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Public Comments - HIV/AIDS Bureau (HAB)

General Comments

Comments from General Public

To understand the impact and burden of our clients we MUST look at ourselves first such as do we understand the discrepancies they face daily, the cultural discrimination they face we need a FULL assessment and knowledge on racism cultural understanding cause most clients that are Black or Hispanic, need to have someone who understands what is going on in there day to day word. Do we truly understand that we are working with HIV infected clients. What does that mean to us? we don't have it or may not know someone personally living with it besides our clients, so how can we know how much of the importance it is to consider that if it only is looked at as a job or career doing the work that we do we can't and never will see the importance of what it means to do the work that we do. Our clients need to feel that they have people, who understands them where they are at. [...]** Not saying we should kiss any ones butt or treat them like they're dying or broken but we should cater to their minds and spirit making them understand that were they are is a new beginning for purpose and a healthier and happier life. Some of us but NOT many of us come from broken homes that some of us are still in so who can we run to how are we going to hide this how long am I going to hide this will I ever talk about it to someone how do I open up that conversation there a whole mind spectrum of things to consider but if we don't start with ourselves than we won't know how to better serve our clients. Sometimes even with transportation for example can be something to consider.

** denotes parts of the comments have been redacted

AIDS Healthcare Foundation (AHF), Los Angeles, CA

AHF is a nonprofit organization dedicated to ending the HIV/AIDS epidemic. It provides HIV/AIDS medical care, prevention and testing, pharmacy, and numerous other services in dozens of Ryan White CARE Act jurisdictions in 15 States and the District of Columbia. Based on this experience providing services across a number of geographies, and under a number of different Ryan White contracts, AHF proposes the following changes to streamline the administration of the CARE Act, and reduce the burdens on CARE Act providers.

AHF's comments are focused the manners in which CARE Act information is collected, and the type and amount of information gathered:

1.  Institute A Uniform System Of Data Collection Across All Ryan White Jurisdictions

Currently, various Ryan White jurisdictions are able to collect program data from providers on different platforms. This requires providers operating in multiple jurisdictions to understand, be trained on, and maintain and supports multiple programs; the inefficiency and extra cost from this situation are obvious. It also makes sharing and using this information across jurisdictions for comparison, effectiveness, and planning purpose difficult if next to impossible.

Given that the CARE Act has been in existence for over 25 years, it should be apparent what system is best suited to fulfil the goals of the Act, and AHF requests that all jurisdictions be required to gather data on the same system.

2.  Reduce The Number Of Reporting Requirements, And Establish Uniform Requirements Across CARE Act jurisdictions

For far too long, the data collected for the CARE act has disappeared into a black hole – very little has actually filtered out to providers in ways that have materially improved their services. In addition, much like the situation regarding data collection platforms set out above, various CARE Act jurisdictions, for their own purposes, require the collection and reporting of other data. This makes for an inefficient and costly system of CARE Act providers being required to track and collect onerous, inconsistent data, the collection of which has an unclear value on the overall effectiveness of the program. AHF recommends that HRSA adopt a concise, uniform data collection set, and that HRSA explicitly state why the required data is being requested, and what benefits uses HRSA, and the CARE Act, will derive from that data.

Eliminate The Requirement To Collect Data On Non-Ryan White Eligible Clients.

It is typical for clinics and facilities that receive Ryan White funding to provide services not just to Ryan White eligible patients, but to other patients as well. The care provided to these other patients in no way impacts the effectiveness or outcomes of the CARE Act. Nevertheless, Ryan White-funded clinics are required to report data on non-eligible patients as well. This increases compliance costs, potentially exposes patients to violations of their privacy, and has no bearing on the CARE Act. Eliminating this reporting requirement would ease the compliance burdens of clinics.

Thank you for your attention in this matter.

AIDS Resource Center of Wisconsin, Milwaukee, WI

The AIDS Resource Center of Wisconsin (ARCW) provides health care, social services and access to pharmacy and medication services to approximately 5,000 people living with HIV in Wisconsin and Colorado, following a recent merger with Rocky Mountain CARES. ARCW receives funding from Parts A, B, and C of the Ryan White HIV/AIDS Program, as a direct grantee and subgrantee, and is a covered entity participating in the 340B Drug Discount Program (340B program). ARCW appreciates the opportunity to respond on the Request for Information: Administrative Streamlining and Burden Reduction that was issued by the Health Resources and Services Administration (HRSA).

Other Issues: Ryan White, 340B and Program Income

Currently, HRSA maintains that savings generated by grantees participating in the 340B are considered program income, and therefore these savings can only be used to cover costs for services allowable under the grant that makes the entity eligible to participate in the 340B program. In the case of Ryan White grantees, this means that 340B savings can only be used to support services allowable under the RWHAP and provided to people living with HIV.

This overly constrictive view of program income and 340B savings prohibits entities like ARCW from being able to use 340B savings to address the needs of the communities they serve or meet evolving organizational needs. In order to meet the goals of the National HIV/AIDS Strategy and move toward realizing an end of HIV/AIDS as an epidemic by the year 2030, HRSA should stop the practices of counting 340B savings as restricted program income and prohibiting the investment of 340B savings into programs and services that can prevent HIV infection from occurring in the first place — namely access to Pre-Exposure Prophylaxis (PrEP) and its necessary clinical services; the prevention, diagnosis and treatment of sexually transmitted infection among at-risk, HIV-negative individuals; and interventions designed to prevent HIV infections among people who inject drugs, in light of the burgeoning opioid epidemic.

AIDS United, Washington, DC

Ryan White Program Geographic Limitations (Equitas Health)

Ryan White grants are issued based on an approved geographic region that consists of a grouping of counties. Program income that is generated in that region may only be used in that region. This policy is incredibly restrictive and inequitable for underfunded regions that the organization serves throughout the state. Equitas Health is fortunate to have robust Ryan White grant funding in Columbus, which generates substantial program income; however, the program income exceeds the volume of expenses that are Ryan White-eligible in this region. While we could continue to grow our Columbus based services using this program income, that would only exacerbate the inequity of funding and services available to clients throughout the state of Ohio. As an organization that operates 17 offices in 11 cities throughout the state, it is crucial for us to be able to use the profits generated by one sector of the organization to sustain underfunded services in another region. Ohio is a geographically diverse state that has several major metropolitan cities, as well as large rural and Appalachian areas. The needs of people living in these areas are varied, but all are significant.

As an example, our Toledo office, located 142 miles away from Columbus, is desperate to use the program income generated by our Columbus site to expand Ryan White eligible services such as behavioral health therapy. However, because of the geographic limitations rule, the Toledo site cannot access that program income. As a result, behavioral health services cannot be expanded in that region and clients ultimately suffer by not having access to services simply due to where they live. All the while, program income goes unused in the Columbus region.

Restricted Program Income Utilization and Consistency (Equitas Health)

The Ryan White program income utilization rules should be aligned with other similar programs’ program income rules to improve consistency and to empower entities to manage resources appropriately and utilize them effectively and efficiently. Ryan White program income requirements are so restrictive that it is challenging to spend the funds. Real unmet needs of organizations such as ours include costly program expenses such as property purchases and renovations, syringe exchange/access programs, and PrEP/PEP services. Covering these expenses would benefit Ryan White beneficiaries and those impacted by HIV, but they are currently unallowable expenses under the existing rules.

340B Revenue as Program Income (Equitas Health)

The difference between third party reimbursement for 340B-eligible medications and the 340B drug purchase price is considered Ryan White program income. 340B income is a significant portion of many Ryan White providers' revenue streams, including ours. Because program income is so heavily restricted, as discussed above, we are hamstrung in the ways in which we can use much of our revenue. We agree with the position taken by Ryan White Clinics for 340B Access ("RWC- 340B") that 340B savings do not fall within the regulatory definition of program income. We also agree with RWC-340Bs assertion that HRSA is exceeding its regulatory authority by adopting a policy that 340B savings are program income. Lastly, and most importantly, we also believe that HRSA’s policy that 340B savings are program income is harmful to individuals with HIV/AIDS and the mission of the RWHAP. We request that HRSA reconsider its position that its policy complies with the law

Ryan White, 340B and Program Income (AIDS Resource Center Wisconsin)

Currently, HRSA maintains that savings generated by grantees participating in the 340B are considered program income, and therefore these savings can only be used to cover costs for services allowable under the grant that makes the entity eligible to participate in the 340B program. In the case of Ryan White grantees, this means that 340B savings can only be used to support services allowable under the RWHAP and provided to people living with HIV.

This overly constrictive view of program income and 340B savings prohibits entities like ARCW from being able to use 340B savings to address the needs of the communities they serve or meet evolving organizational needs. In order to meet the goals of the National HIV/AIDS Strategy and move toward realizing an end of HIV/AIDS as an epidemic by the year 2030, HRSA should stop the practices of counting 340B savings as restricted program income and prohibiting the investment of 340B savings into programs and services that can prevent HIV infection from occurring in the first place – namely access to Pre-Exposure Prophylaxis (PrEP) and its necessary clinical services; the prevention, diagnosis and treatment of sexually transmitted infection among at-risk, HIV-negative individuals; and interventions designed to address the burgeoning opioid epidemic.

CAEAR Coalition, Washington, DC

The CAEAR Coalition is the oldest national HIV/AIDS organization representing the interests of people living with HIV/AIDS, community-based service providers, and the public health grantees of the Ryan White CARE Act. CAEAR targets its advocacy on behalf of the Part A eligible metropolitan areas and the community-health centers directly funded through Ryan White Part C.

CAN Community Health, Inc., Sarasota, FL

CAN Community Health, Inc., (CAN), is a not-for-profit 501(c)(3) organization based in Sarasota County serving those infected and affected by HIV/AIDS and the community at large. CAN has been serving the needs of the HIV/AIDS community in Sarasota and throughout the Southeast for 28 years. We are dedicated to the treatment, care and continual wellness of people living with the HIV disease, Hepatitis C and Sexually Transmitted Diseases (STDs). Our Sarasota Headquarters clinic offers medical, dental, psychological and lifestyle counseling to all patients, regardless of their financial situation, insurance status, or ability to pay. CAN provides a broad scope of services under two Ryan White Part B contracts (Sarasota and Daytona Beach), as well as a Part A contract in Jacksonville. CAN is also a subcontractor for medical services in two other Part A areas, Broward and Pinellas Counties in Florida.

We welcome the opportunity to provide feedback on reducing RWHAP program burdens and increasing efficiency. We affirm that the reduction or improvement of administrative process frees up resources for more direct services to clients. Ultimately, this is what both CAN and HRSA want. Implementing the proposed changes to the eligibility process, and not implementing the proposed changes to client-level reporting, will promote this outcome.

Central Carolina Health Network, Greensboro, NC

Central Carolina Health Network (CCHN) receives Ryan White Part D funds and Part B funds (as a subcontractor through the state of North Carolina). We serve over 1,700 HIV positive individuals and their families each year so that they can lead healthy, productive lives while managing their HIV. Our network includes 13 different service providers that we must coordinate with to ensure the Ryan White eligibility when serving clients.

Central Carolina Health Network, Greensboro, NC

Triad Health Project

On behalf of Triad Health Project, I respectfully submit the following comments from staff regarding the process of completing eligibility documents twice annually. In my experience with these forms during the past 25 years (both HMAP eligibility and for patients with ESRD), it is incredibly onerous and difficult for many clients to complete these documents even once a year. Many of our population are challenged with other factors, such as homelessness, mental illness, and substance abuse, and often only have their HIV controlled while these other problems are present. Clients inevitably are unreachable during the 45 day enrollment periods, resulting in loss of medication and medical access. All too frequently, North Carolina's program or the clients' pharmacies fail to notify clients of renewal dates in a timely fashion, if at all.

Case Manager Kathryn Weitzner: "While I understand the importance of re-enrollment, I believe that going back to a once yearly HMAP re-enrollment would be greatly beneficial to the client s we serve. Clients who utilize the HMAP program are typically the most vulnerable individuals that we serve. Many have unstable housing, income, jobs, and access to healthcare. The re-enrollment process can be a lot for these clients to track down necessary documents and get to the office for an appointment. Unfortunately, we oftentimes have clients who are unable to complete re-enrollment in time, and thus lose access to medications and healthcare for a period of time. In addition, as a case manager with a majority of clients served by the HMAP program, it is very time consuming to complete r e-enrollment for each individual on my caseload. It oftentimes takes away valuable time that I would be able to work on meeting clients' other basic needs."

Case Manager Meagan Patillo: "7 pages? The postage alone."

Case Manager Annie Segal: "Having to apply for Medication Assistance Programs twice annually is very taxing on our clients. Many clients struggle with transportation. Requiring clients to come in and fill out the same forms twice a year creates a burden on the client for transportation for an unnecessary trip, when other needs can be met via a phone call. The overall burden of twice annual renewals costs agencies money in bus tickets, staff time, postage, and client frustration."

Our staff shares the opinion that two annual re-enrollments results in additional health issues for our clients and increases our community viral load, resulting in more clients and more re-enrollment s. One annual enrollment would certainly improve our patient and community outcomes.

Equitas Health, Columbus, OH

Equitas Health is a nonprofit, community-based health care organization serving more than 67,000 individuals across Ohio through a diverse set of services, including primary and specialized medical care, behavioral health, dental care, HIV/STI prevention, advocacy, and case management. We are a Federally Qualified Health Center, and also operate three pharmacies. Our mission is to be the gateway to good health for those at risk of or affected by HIV/AIDS, for the LGBTQ community, and for those seeking a welcoming health care home.

As the largest provider of Ryan White services in Ohio, we appreciate the opportunity to provide input on this very important topic. Policies and guidance peculiar to the Ryan White Program — including those related to program income, covered services, and eligible beneficiaries — are uniquely overbroad and restrictive. In this document, we particularly wish to comment on constraints on program income.

Geographic Limitations

Ryan White grants are issued based on an approved geographic region that consists of a grouping of counties. Program income that is generated in that region may only be used in that region. This policy is incredibly restrictive and inequitable for underfunded regions that the organization serves throughout the state. Equitas Health is fortunate to have robust Ryan White grant funding in Columbus, which generates substantial program income; however, the program income exceeds the volume of expenses that are Ryan White-eligible in this region. While we could continue to grow our Columbus based services using this program income, that would only exacerbate the inequity of funding and services available to clients throughout the state of Ohio. As an organization that operates 17 offices in 11 cities throughout the state, it is crucial for us to be able to use the profits generated by one sector of the organization to sustain underfunded services in another region. Ohio is a geographically diverse state that has several major metropolitan cities, as well as large rural and Appalachian areas. The needs of people living in these areas are varied, but all are significant.

As an example, our Toledo office, located 142 miles away from Columbus, is desperate to use the program income generated by our Columbus site to expand Ryan White eligible services such as behavioral health therapy. However, because of the geographic limitations rule, the Toledo site cannot access that program income. As a result, behavioral health services cannot be expanded in that region and clients ultimately suffer by not having access to services simply due to where they live. All the while, program income goes unused in the Columbus region.

Restricted Program Income Utilization and Consistency

The Ryan White program income utilization rules should be aligned with other similar programs' program income rules to improve consistency and to empower entities to manage resources appropriately and utilize them effectively and efficiently. Ryan White program income requirements are so restrictive that it is challenging to spend the funds. Real unmet needs of organizations such as ours include costly program expenses such as property purchases and renovations, syringe exchange/access programs, and PrEP/PEP services. Covering these expenses would benefit Ryan White beneficiaries and those impacted by HIV, but they are currently unallowable expenses under the existing rules.

340B Revenue as Program Income

The difference between third party reimbursement for 340B-eligible medications and the 340B drug purchase price is considered Ryan White program income. 340B income is a significant portion of many Ryan White providers' revenue streams, including ours. Because program income is so heavily restricted, as discussed above, we are hamstrung in the ways in which we can use much of our revenue.

We agree with the position taken by Ryan White Clinics for 340B Access ("RWC-340B") that 340B savings do not fall within the regulatory definition of program income. We also agree with RWC-340B's assertion that HRSA is exceeding its regulatory authority by adopting a policy that 340B savings are program income. Lastly, and most importantly, we also believe that HRSA's policy that 340B savings are program income is harmful to individuals with HIV/AIDS and the mission of the RWHAP. We request that HRSA reconsider its position that its policy complies with the law and does not have a harmful effect on patients that Ryan White clinics seek to serve.

Harris Health System HIV - Services, Houston, TX

ADAP has a justifiable proud history of serving patients with HIV, and the program is deeply appreciated and acknowledged by Thomas Street Health Center, a facility within Harris Health System. Due to the added "Six Month Self-Attestation," process now required by ADAP, approximately 400 of our patients have been dis-enrolled due to missing this required component within the last ten months. Subsequently, disenrollment has negatively impacted our patients and the health care team in the following ways:

  • Negative effects on the community, where transmission risks are now increased due to loss of viral control due to interruptions in medication regiments.
  • Strain on the healthcare system, including all disciplines, which now must devote resources to re-enrollment of an established patient, while new patients are waiting for services.
  • Loss of physician productivity when having to explain this process to patients, write new prescriptions and fill out the extensive paperwork.
  • Fiscal impact on all programs and services that provide interim prescription coverage.

As the healthcare system that provides HIV care to the largest number of patients in the Greater Houston area, we ask for your understanding that our patient population has many barriers to care. These include:

  • Limited access to regular US Mail to receive ADAP notices due to transiency.
  • Limited resources regarding literacy, language barriers, transportation, cultural barriers and stigma.
  • Limited access to phones needed for verbal attestation.

We would like the following options made available for the "Six Month Self-Attestation:"

  1. Approval for staff to "attest" on behalf of our patients by phone, without the presence of the patient, in cases where the information has been confirmed.
  2. Extend the "hold" for six months before dropping the patient from ADAP.

We thank ADAP for its consideration of the above and encourage you to continue the mission of providing medication assistance to those in need who live with HIV/AIDS.

HIV Medicine Association, Arlington, VA

Dear Dr. Sigounas and Dr. Cheever:

We are writing on behalf of the HIV Medicine Association (HIVMA) and the Ryan White Medical Providers Coalition (RWMPC) in response to the Health Resources and Services Administration's (HRSA) Request for Information: Administrative Streamlining and Burden Reduction due on July 2, 2018. HIVMA represents nearly 5,000 physicians, scientists, and other health care professionals working on the frontlines of the HIV epidemic across the U.S. RWMPC is a coalition of medical providers and administrators nationwide who work in clinics supported by the Ryan White HIV/AIDS Program. Thank you for requesting our input on important questions regarding the administration of the Ryan White Program.

Conclusion

Thank you so much for your time and consideration of HIVMA's and RWMPC's input on these important Ryan White Program questions. Continuing to improve the administrative efficiency and effectiveness of the Ryan White Program while reducing patient and grantee burden whenever possible will increase the excellence of the Ryan White Program, an essential component to achieving an AIDS-free generation.

Legacy Community Health, Houston, TX

In an effort to respond to HRSA's request for recommendations on changes to regulations or guidance that could reduce burden and increase efficiencies for grant recipients, Legacy has provided the specific recommendations below.

Suggestion #1 for HAB: Allow greater flexibility for the use of 340B savings

Allowing greater flexibility in areas specifically related to the mission of HIV service organizations would significantly improve the services of HIV organizations and agencies. HRSA and Congress should clarify that Program Income from the 340B Drug Discount Program be acceptable for uses that comport with section 330 grantees (Federally Qualified Health Centers) and/or specifically functions within subgrantee operations to support health and end the HIV epidemic. Such common uses could include: HIV Prevention services including Pre-Exposure Prophylaxis (PrEP); funding for Sexually Transmitted Infections (STI) prevention services; construction of accommodations to benefit patients; and reasonable reserve funding (6 months) for use when regular income is disrupted or reduced in order for typical operations to continue.

Suggestion #2 for HAB: Remove HAB’s prohibition on construction costs for Ryan White HIV/AIDS Program (RWRAP) Parts C and D

It would benefit patients if HAB allowed Part C and D providers to propose construction projects, and approve the projects when appropriate. In particular, HAB should exercise its authority to allow the application of program income for such purposes to enable investments in the RWHAP program that benefit the program, the grantees, and the beneficiaries over the long term.

The McGregor Clinic, Inc, Fort Myers, FL*

The McGregor Clinic, on behalf of the clients and community we serve, greatly appreciates this opportunity to provide the Health Resources and Services Administration ("HRSA") and its HIV/AIDS Bureau ("HAB") with feedback on how HAB can streamline guidance to reduce administrative burdens, eliminate inconsistencies with statutory authorities, and otherwise improve the RWHAP without affecting the agency's ability to perform adequate oversight. We have been a Ryan White HIV/AIDS Program ("RWHAP")-funded clinic since our privatization in 1999. We are unique in that our clinic was founded and is governed by the clients and the community. These funds have allowed us to increase the number of clients served from 150 in 1999 to 1200 in 2017.

HIV is now a manageable chronic illness and our clients are now able to live healthier and longer lives as long as they access care. Current funding restrictions have become a barrier to care as we continue to best meet the outcomes as set forth in the National HIV/AIDS Strategy and the NHAS 2020 updates. Admission of new clients as a result of increased testing and diagnosis stretches resources while the limitations of the PCN does not allow us to utilize funds to meet the greatest needs.

Please consider our comments as you review possible deregulatory actions to take in response to Executive Order 13771 and the Office of Management and Budget's Final Bulletin for Agency Good Guidance Practices. If you have any questions regarding these comments, or would like any additional information, please do not hesitate to contact us at 239-334-9555, ext. 8018.

Feldesman Tucker Leifer Fidell LLP, Washington, DC*

*The comments below were identical from both entities.

Clarifying Patient Income Requirements and the Payer of Last Resort Standard

Comment 1: Correct Existing Guidance That Misrepresents the RWHAP's Low-Income Protections

The RWHAP statute contains protections for low-income PLWHA, but the program is not limited to low-income individuals. HRSA should correct guidance that implies otherwise, while encouraging grantees to ensure that all low-income patient needs are met before applying resources to higher-income individuals.

The Issue

The RWHAP statute prohibits the imposition of charges on individuals with an income less than or equal to 100 percent of the federal poverty line ("FPL"), and caps the total annual charges for individuals with incomes above 100 percent of the FPL.1 RWHAP contains further protections for low-income individuals through the "payer of last resort" provision (discussed in more detail in Comment 2, below).

However, the RWHAP statute does not limit program eligibility to only low-income individuals. In fact, the statute makes clear that all PLWHA are potentially eligible for some or all services. In particular, it requires that Part A and Part B grantees to "furnish services without regard to the ability of a patient to pay."2 Moreover, it provides for no upper cap in requiring that the maximum annual amount that a RWHAP-funded clinic may charge a patient whose income is above 300% of the FPL is 10% of his or her annual income. 3

Yet Policy Clarification Notice ("PCN") 13-02 states that "[t]he RWHAP legislation requires that individuals receiving services through the RWHAP must have a diagnosis of HIV/AIDS and be low-income as defined by the RWHAP grantee."4 The restriction that RWHAP program service eligibility is limited to low-income individuals seems to have been read into the law, but it never appears there.

Later guidance, including PCN 16-02, describes "eligible individuals" in some detail without referencing any expectation that all recipients of RWHAP-funded services would be below a certain income threshold.5 PCN 13-05 describes premium assistance as a possible service to individuals with incomes as high as 400% of the FPL or greater.6

PCN 13-02's stated limitation that to be an eligible beneficiary a person must be low-income adds (without authority and in a manner directly conflicting with the RWHAP statute) a new legal requirement to the RWHAP program through sub regulatory guidance. The limitation creates unnecessary burden on the ability of grantees to structure programs that will be most effective for meeting the RWHAP's purpose of "provid[ing] for the development, organization, coordination and operation of more effective and cost-efficient systems for the delivery of essential services to individuals and families with HIV disease."7

Negative Impact of the Guidance

The RWHAP authorizes recipients to provide many core medical and support services that have proven highly effective for treating PLWHA, but which are rarely reimbursed by traditional health insurance. These so-called “wrap-around” services benefit PLWHA regardless of their income, and facilitate the linkage, retention, therapy, and viral suppression numbers seen in RWHAP-funded clinics. Depriving an individual of those services does a disservice to the broader PLWHA community.

In addition, PLWHA might not stay in a specific income band. Many RWHAP services are most effective when they are provided continuously, and not when they are started and stopped due to income fluctuations. The implementation of income-based limitation guidance that is inconsistent with the RWHAP statute places grantees in the untenable position of having to potentially deny (at risk of a program finding or HAB-initiated disallowance) statutorily authorized benefits based on inconsistent sub-regulatory guidance, placing them at risk of disputes with potential beneficiaries, subrecipients and subcontractors.

Suggested Solution

Under the RWHAP statute, the decision to prioritize particular services to low-income individuals appears intended to be left to the discretion of the grantee. RWHAP guidance should confirm this statutory intent, but not imply that RWHAP resources may never be allocated to individuals who earn more than 300%, 400%, or some other arbitrary income ceiling.

The RWHAP statute contains support for the prioritization of resources in such a manner. For Parts A and B, the statute requires the grantee's application to include assurances that the grantee will (i) "ensure [RWHAP] services will be provided in a setting that is accessible to low-income individuals with HIV/AIDS . . . and (ii) "provide outreach to low-income individuals with HIV/AIDS."8 Similarly, for State-administered programs under Part B that offer "Continuum of Health Insurance Coverage" services, such services are to be targeted at individuals who could not otherwise afford the coverage, and grantees are to set eligibility criteria.9 This requirement both furthers the point that the statute does not limit beneficiaries to low-income individuals and the point that the statutory scheme is designed to afford grantees flexibility on a service-by-service basis, so long as assistance to low-income individuals is prioritized.

For the reasons stated above, we request that PCNs 13-02 and 16-02 (and other RWHAP guidance as necessary)10 be corrected and/or clarified to indicate that income thresholds for eligibility may be set by the grantee at any level (or, when appropriate, not applied at all), so long as the grantee ensures its services are made available to low-income individuals.

Comment 2: Clarify the Application of the RWHAP Payer of Last Resort Requirement to Non-Health Care Services and Situations in Which RWHAP Is Not Acting as a Payer

The RWHAP "payer of last resort" expectations lead to confusion among RWHAP providers. Due to some overbroad HAB guidance, some providers will only provide RWHAP resources to the uninsured, or will not provide support services if similar services are available in the community. HAB should clarify its existing guidance and amplify guidance that explains that RWHAP resources may be used to fill gaps in health care services and may be used to provide support services regardless of an individual's health coverage.

The Issue

The RWHAP "payer of last resort" restriction appears in RWHAP Parts A, B, and C. In Part A, the provision states that RWHAP funds may not be utilized:

to make payments for any item or service to the extent that payment has been made, or can reasonably be expected to be made, with respect to that item or service—(A) under any State compensation program, under an insurance policy, or under any Federal or State health benefits program (except for a program administered by or providing the services of the Indian Health Service); or (B) by an entity that provides health services on a prepaid basis.11

Though the statutory limitation applies only to payments made under state compensation programs, insurance policies, and federal or state health benefits programs, HAB guidance states that RWHAP funds cannot be used to pay the cost of a service where any other funding is available.12 Additionally, for RWHAP Part C, the limitation is applied by the statute only to EIS services;13 and for RWHAP Part D the limitation (to the questionable extent it might be construed as a limitation under its wording) is stated only in reference to "primary care services."14

Negative Impact of the Guidance

First, HAB's overly broad guidance on the payer of last resort provision has potential to be erroneously construed to mean that RWHAP-funded services may only be provided to PLWHA who lack health insurance. That misconception unnecessarily limits the ability of the provider to render needed support services to PLWHA.

Further, though the statute only requires certain listed types of funding be sought and/or applied before RWHAP funds may be used to provide services for PLWHA, HAB's guidance implies any and all funding or payment sources other than RWHAP funds must first be exhausted. Of particular importance are federal non-healthcare sources of funding (which the statute does not mention). For example, HAB guidance implies that a grantee that receives HOPWA funding could not use RWHAP funding to support housing services without first exhausting all available HOPWA funds. Such rules make proper allocation of expenses under the federal costs principles unnecessarily complicated.

Suggested Solution

RWHAP guidance should be clarified to more closely follow the actual limited statutory restriction. HAB should clarify that while RWHAP providers may not use RWHAP funds when another healthcare funding source is available, they may use RWHAP funds to provide support services (regardless of whether other funding sources may be available to provide support for those services). HAB should emphasize guidance that indicates that RWHAP resources may be applied to healthcare services "not covered, or partially covered, by public or private health insurance plans."15 We appreciate that HAB made that point in recently released Policy Clarification Notice 18-01.

HAB might also wish to reemphasize that, irrespective of the payer of last resort provision, the Uniform Administrative Requirements at Part 75 of Title 45 of the Code of Federal Regulations contain expenditure control and budget mechanisms in the form of the Cost Principles at Subpart E.

Eliminating Unnecessary Restrictions on Program Income Calculation and Expenditures

Comment 3: HAB's Blanket Prohibition on Construction Costs for RWHAP Parts C and D Is Incorrect and Is Harmful to Grantees, Beneficiaries, and the RWHAP Program.

Many providers funded under Parts C and D of the RWHAP are utilizing outdated and cramped facilities. Some have the potential to generate sufficient resources to fund construction or major renovation of their facilities, but HAB has imposed a blanket prohibition on construction costs. That prohibition is not supported by the statute to the extent applied, and should be revised to reflect the actual scope of the statutory limitation.

The Issue

HAB has stated repeatedly that construction activities are prohibited by the RWHAP statute. For Parts A and B, the RWHAP statute provides that grant recipients may not use "amounts received under a grant" awarded under Parts A or B to "purchase or improve land, or to purchase, construct, or permanently improve (other than minor remodeling) any building or other facility." Those prohibitions do not appear in Parts C and D. However, multiple HAB issuances have extended the prohibition to Parts C and D.

For example, in the Frequently Asked Questions ("FAQs") issued by HAB on March 21, 2016 to interpret PCNs 15-03 and 15-04, HAB described "[c]onstruction and/or major alteration or renovation" as a specific example of a cost toward which a grantee may not apply program income (as defined in 45 C.F.R. § 75.2 and discussed in more detail below).17 In an April 2016 FAQ document issued specifically for RWHAP Parts C and D, HAB's Division of Community HIV/AIDS Programs wrote:

4. Can 340B program income be used for building new facilities?

No. Construction is an unallowable expense under the RWHAP, including Part C and Part D. Consequently, program income may not be used for construction.18

The FAQ repeats the statement in its paragraph 17, stating that "those costs that are expressly articulated by statute as being unallowable, including construction…, may not be funded by program income."19

In the OMB Compliance Supplement, the support cited for this restriction for Part C funds (CFDA 93.918) is 42 U.S.C. § 300ff-64(g)(1). Subsection 300ff-64(g)(1) provides merely a general statement that the applicant must agree that it "will not expend amounts received under this part [i.e., RWHAP Part C] for any purpose other than the purposes described in [Part C]." That general sentiment appears in Parts A and B as well,20 yet in those areas Congress still felt the need to specify that construction is not an allowable cost.

Agencies must presume that Congress "says in a statute what it means and means in a statute what it says."21 The absence of the construction prohibition in the language of Parts C and D indicates that Congress intended to authorize such activities for Part C and D grants, not prohibit them. Also, the Supreme Court has said that statutes must be read so as to avoid interpreting "a statutory provision so as to render superfluous other provisions in the same enactment."22 If the general limitation on the use of RWHAP funds for core medical services, support services, and administrative expenses appears in Parts A, B, and C, and Congress felt the need to specify that construction costs are not allowed in Parts A and B, we must presume that Congress intended to permit construction costs under Part C. HAB cannot impose a new funding condition, because Congress, and not the executive branch, sets funding conditions.23

While program income is subject to a federal interest and subject to certain of the same terms and conditions as the federal funds, HAB can authorize broader use of program income than it can grant funds. For example, HAB has explained in the HAB FAQ issuance for PCNs 15-03 and 15-04 that the internal thresholds for certain types of expenditures such as the 75 percent core medical services threshold, 50 percent early intervention services ("EIS") threshold, and 10 percent administrative cost cap do not apply to program income.24

Moreover, to remove this unsupported limitation would not remove HAB's authority to exercise judgment in authorizing construction-type activities under RHWAP Parts C and D, as the federal cost principles require express prior approval all capital expenditures funded with federal grant funds.25

Negative Impact of the Guidance

Some RWHAP Part C providers have the resources, primarily in the form of program income, to fund much-needed construction and renovation projects. Due to the stated application of a construction prohibition to Part C, those providers are forced to waste program income on renting unsuitable space or are unable to provide services to their full potential due to existing space and facility limitations.

Moreover, were HAB to authorize the use of RWHAP Parts C and D funds, or RWHAP Part C or D program income for such purposes, the RWHAP program would benefit from the long term federal interest investment in the property.26 Currently, RHWAP recipients are forced to rent facilities, with long term benefits instead accruing to their landlords.

Suggested Solution

HAB should permit Part C and D providers to propose construction projects and should approve the projects when appropriate. HAB should exercise its authority to permit application of program income for such purposes to enable investments in the RWHAP program that benefit the program, the grantees, and the beneficiaries over the long term.

Comment 4: Clarify 340B Drug Revenue Program Income Calculations

HRSA clarified in late 2015 and early 2016 that 340B program pharmacy revenues (whether directly earned or earned through a contract pharmacy) constitute "program income" within the meaning of 45 C.F.R. § 75.2. For many RWHAP providers, pharmacy-related program income is the largest source of revenue. HAB should explicitly permit RWHAP grantees to deduct the underlying cost of generating program income from the total reimbursement received when calculating program income, so long as that cost has not been charged to the grant elsewhere.

The Issue

Under federal regulations, non-federal grantees are restricted in how they can spend "program income." Program income is "gross income earned by the non-Federal entity that is directly generated by a supported activity or earned as a result of the Federal award during the period of performance…"27 Grantees are encouraged to earn program income.28 If authorized by the federal agency making the award, program income does not include the "costs incidental to the generation of program income" so long as those costs have not been charged to the federal award.29 RWHAP providers must add program income to their grant funding and use the program income "for the purposes and under the conditions of the Federal award."30 Program income must be spent before RWHAP dollars can be applied.31

Patient service revenue (i.e., reimbursement) is the most common source of program income for RWHAP providers, and pharmacy reimbursement is often the largest source of patient service revenue. Current HAB guidance indicates that, in the context of 340B drug sales, program income is the "difference between the third-party reimbursement and the 340B drug purchase price."32 HAB does not address any other costs incident to the generation of 340B drug revenue.

Negative Impact of the Guidance

HAB currently does not recognize many of the costs inherent in generating 340B drug revenue. RWHAP providers suffer from having "too much" program income because they may only expend program income in accordance with the purposes and conditions of the underlying award, which can be restrictive. For Part A and B recipients (and Part C recipients under HAB's interpretation), program income cannot be spent on construction or major renovations. For all RWHAP Parts, program income cannot be used to purchase pre-exposure prophylaxis (PrEP).33 The reimbursement for a 340B drug is made up of many calculable components, including the cost of the drug, the cost of dispensing it, the cost of complying with 340B program requirements, and the amount of reimbursement. Under HAB's guidance, the program income is the reimbursement minus the cost of the drug. That method neither accurately accounts for the costs incidental to the generation of the income nor the part of the activity that is actually "supported" by the federal award.

Suggested Solution

HAB should recognize that the costs incidental to the generation of 340B program revenue include dispensing and compliance costs, and permit RWHAP grantees to deduct those costs from gross program income to the extent the costs have not otherwise been charged to the grant. The 340B program, which is managed by HRSA's Office of Pharmacy Affairs, requires strict compliance with program requirements, especially when a contract pharmacy model is used.34 RWHAP providers typically must pay a dispensing fee each time a contract pharmacy dispenses the provider's 340B drug inventory, and typically must pay an administrative fee to a compliance vendor whenever a 340B drug is dispensed (regardless of whether it is dispensed from an in-house or contracted pharmacy). Further, HRSA expects each 340B program participant to conduct an annual independent audit of every single contract pharmacy site. An entity that is not willing to incur those costs cannot participate in the 340B program. Thus, the costs are incidental to the generation of 340B program revenue.

The incidental costs of generating 340B program income, including dispensing fees, administrative fees, and independent audit costs, that are not otherwise charged to the federal grant should be deducted from gross program income. HAB should issue guidance clarifying its treatment of the costs.

Comment 5: Waive Prior Approval Requirements for Special Purpose Equipment Purchases under $25,000 and Program Income Expenditures

RWHAP grantees and subgrantees often must wait months to obtain approval for expenditures for which prior approval is not required in other programs. HAB should waive prior approval requirements for equipment purchases that cost less than $25,000 and for program income expenditures.

The Issue

Capital expenditures for special purpose equipment purchases in excess of $5,000 typically require the prior written approval of the awarding agency or pass-through entity.35 Agencies within HHS, however, have expanded authority under the HHS Grants Policy Statement to waive certain prior approval requirements.36 Agencies have the authority to waive cost-related prior approvals for direct cost items, including equipment, except when the purchase would result in a change of scope.37

Negative Impact of the Guidance

RWHAP grantees and subgrantees go months without needed equipment because the approval process is time-consuming.

Suggested Solution

HRSA should waive prior approval requirements for special purpose equipment purchases of less than $25,000, when program income is being used rather than grant funds. Such a $25,000 threshold for equipment purchases is common within federal grant programs. For example, it is applied under the National Institutes of Health (“NIH”) Grants Policy Statement.38 The government-wide standard research terms and conditions administered by the National Science Foundation ("NSF").39

Other Issues

Comment 6:Clarify Status of ADAP Rebate Dollars as RWHAP Part B "Support"

State ADAP programs are able to generate "rebates" through their coverage of drug costs. Some rebates come from 340B program discounts, while others are supplemental rebates negotiated between ADAPs and manufacturers. ADAPs must use drug rebates for activities supported under Part B.40

The Issue

At least one RWHAP provider has been told by HAB that ADAP rebate dollars do not constitute "assistance under subchapter XXIV" of the Public Health Service Act, which is the trigger for the subrecipient to participate in the 340B program (though the agency is still examining that conclusion).41 Under 45 C.F.R. § 75.305(b)(5), Part B grantees must expend rebate dollars before drawing down additional grant funding. Some states apparently did not do that, and now are only spending rebate dollars. Those dollars, which must be spend in accordance with RWHAP Part B by statute, clearly constitute "assistance" through the RWHAP.

The contrary preliminary conclusion expressed by HAB is illogical for the following reasons: (i) the 340B statute uses the broad term "assistance" as the triggering condition for 340B eligibility,4 (ii) ADAP rebate funds are expressly made available to States for use under the RWHAP statute,43 and (iii) the Uniform Guidance defines "financial assistance" as including not just "grants," but also "[n]on-cash contributions or donations of property" and "[o]ther financial assistance."44 Moreover, even were the 340B statute to use the specific term "grant," the result would likely be the same because the Federal Grant and Cooperative Agreement Act of 1977 defines "grants" broadly, covering the transfer "things of value" and not merely cash.45

Clear guidance from HAB on this issue would correct current misinterpretation and avoid similar future misinterpretations, alleviating unnecessary burden upon their subrecipients.

Negative Impact of the Guidance

Logically, the nature of the dollars received as "assistance" from a Part B grantee should be irrelevant to 340B eligibility.

If rebate dollars were not assistance under RWHAP Part B, subgrantees would move in and out of eligibility depending on whether the state is expending program income, rebate dollars, refunds, contract settlements, etc. A Part B grantee might expend grant funds, then rebates, then grant funds again over the course of a year. Given the three- to six-month lag time to re-enter the 340B program once eligibility is lost, it would be untenable for the RWHAP to have front line providers lose and gain access to the program, and thus lose and gain the ability to offer program benefits and pharmacy-supported services to patients.

Suggested Solution

Publicly clarify that Part B rebate dollars sub granted to other RWHAP providers constitute "assistance" under Part B within the meaning of the 340B program statute. Coordinate with the Office of Pharmacy Affairs to eliminate any misunderstanding.

Comment 7:Eliminating Requirements to Budget Personnel by Specific Name as Opposed to Merely Position and FTE.

The Issue

HAB requires grantees to provide specific provider names in their budget justifications, implying that those specific individuals are the only individuals for whose salaries and wages RWHAP funds should be used. Some state and municipal passthrough entities ("PTEs") require budgeting by individual named providers, insisting that only the salary and fringe costs of those specific individuals are allowable.

HAB should clarify that its budget justifications should not be construed as creating any binding obligation that the grantee pay for the specific individuals listed in the budget justification with RWHAP funds, and that PTEs should impose no such requirement. The Uniform Guidance46 and Department of Health and Human Services Grants Policy Statement ("GPS")47 provide, when read together, that so long as the grantee does transfer, between budget categories, funds in excess of twenty five percent (25%) of the total approved budget, no approval of the awarding agency is required. Moreover, the Uniform Guidance requires that this flexibility be flowed down to subrecipients by PTEs.48

Negative Impact of the Guidance

Often, RWHAP grantees allocate costs and develop budgets on an FTE basis without regard to who individual providers are (for example, historical data may show that 0.7 FTE registered nurses are needed, but that 0.7 FTE is comprised of the combined periodic effort of a pool of four different individuals). It is simply not feasible for many entities to employ providers dedicated to furnishing services only to HIV-positive individuals, and it is rarely the most economical approach to employing providers. When HAB implies, and PTEs require, budgeting by individuals, grantee operations are greatly impacted; requiring either (i) unusual and inefficient staffing patterns, or (ii) use of specifically named individuals as mere "placeholders" with the hope that such use of individuals as placeholders is not later construed by a PTE as a misrepresentation by the subrecipient.

Suggested Solution

Issue guidance clarifying that HAB does not require, and PTEs may not require, budgeting by specific named individuals, in HAB FOAs and its Part A and B manuals.

Comment 8: Suspend Changes to RSR Expenditure Reporting and Reduce Eligibility Recertification to Once Annually until CAREWare Is Modernized.

The RFI requests feedback specific proposals for (i) additional and more detailed Ryan White Services Report ("RSR") submissions; and (ii) ways in which the semiannual eligibility recertification process burden can be reduced. Both issues are addressed together, because both implicate needed improvements to CAREWare.

The Issue

HRSA's proposals rely to some extent on HRSA's CAREWare system, which is badly outdated and increasingly ill-equipped to support modern health care operations.

The Burden

CAREWare has not kept pace with modern electronic medical record systems. Increasingly, RWHAP providers must resort to manual processes to work around CAREWare's limitations. Those limitations increase the burden on RWHAP clinics trying to recertify twice annually that patients are eligible to receive RWHAP-funded services. They also would make any changes to RSR reporting more burdensome than necessary.

Suggested Solution

Refrain from requiring additional RSR reporting on expenditures until CAREWare has been modernized. Pare recertification back to once annually until CAREWare has been modernized.


1 42 U.S.C. §§ 300ff-15(e); 300ff-27(c); 300ff-64(e).
2 42 U.S.C. §§ 300ff-15(a)(7)(A)(i) (Part A) and 300ff-27(b)(7)(B)(i) (Part B).
3 42 U.S.C. §§ 300ff-15(e)(1)(C) (Part A), 300ff-27(c)(1)(E) (Part B), and 300ff-64(e)(2)(C) (Part C).
4 HRSA, HAB, Policy Clarification Notice ("PCN") 13-02 at 1.
5 HRSA, HAB, PCN 16-02 at 2-3.
6 HRSA, HAB, PCN 13-05 at 5.
7 42 U.S.C. § 300ff.
8 Id. §§ 300ff-15(a)(7)(B)–(C) (Part A), 300ff-27(b)(7)(B)(ii)–(iii) (Part B).
9 Id. § 300ff-27(b)(7)(B)(iv).
10 Other pertinent guidance may include, but would not necessarily be limited to, the RWHAP Part A and B Manuals, Site Visit Guides, and the OMB Subpart F Audit Compliance Supplement for RWHAP programs.
11 42 U.S.C. § 300ff-15(a)(6) (limitation as stated in Part A); see also §§ 300ff-27(b)(7)(F) (nearly identical language for Part B), 300ff-64(f)(1) (identical language for Part C); 300ff-71(i) ("Nothing in this part shall be construed as requiring funds under this part be used for primary care services when payments are available for such services from other sources (including under titles XVIII [Medicare], XIX [Medicaid], and XXI of the Social Security Act).").
12 See, e.g., RWHAP Part A Manual at 33 ("By statute, the RWHAP funds may not be used for any item or service 'for which payment has been made or can reasonably be expected to be made' by another payment source . . ." (emphasis added)); Part B Manual at 63 (identical language to the Part A Manual); HRSA, HAB, PCN 10-02 at 2 ("The RWHAP statute, codified at title XXVI of the Public Health Service Act, stipulates that ‘funds received . . . will not be utilized to make payments for any item or service to the extent that payment has been made, or can reasonably be expected to be made . . .’ by another payment source." (emphasis added)); HRSA, HAB, PCN 13-02 at 1 ("By statute, RWHAP funds may not be used for any item or service ‘for which payment has been made or can reasonably be expected to be made’ by another payment source . . ." (emphasis added)); HRSA, HAB, PCN 13-05 at 1 (identical language to PCN 13-02);
13 42 U.S.C. § 300ff-64(f).
14 42 U.S.C. § 300ff-71(i).
15 HRSA, HAB, PCN 13-03 at 2.
16 42 U.S.C. §§ 300ff-14(i) (construction prohibition for Part A funds); 300ff-22(f) (construction prohibition for Part B funds).
17 HRSA, HAB, FAQ on PCNs 15-03 and 15-04 (Mar. 21, 2016), ¶ 4, at https://hab.hrsa.gov/sites/default/files/hab/Global/faq15031504.pdf.
18 HRSA, HAB, Parts C/D FAQ on Program Income/Maintenance of Effort (April 2016), ¶ 4, at https://careacttarget.org/sites/default/files/supporting-files/FINAL_DCHAP%20Program%20Income%20FAQ_051016.pdf. HRSA Exit Disclaimer.
19 Id., ¶ 17.
20 42 U.S.C. §§ 300ff-14(a)(1)(2) (Part A — "The Secretary may not make a grant…unless such political subdivision agrees that…funds provided under [Part A] will be expended only for…[core medical services, support services, and administrative expenses."), 300ff-22(a) (Part B — "A State may use amounts provided under grants made under [Part B] for [core medical services, support services, and administrative expenses.")
21 Conn. Nat. Bank v. Germain, 503 U.S. 249, 254 (1992).
22 Pa. Dept. of Pub. Welfare & Dev. v. Davenport, 495 U.S. 552, 562 (1990).
23 See, e.g., South Dakota v. Dole, 483 U.S. 203 (1987).
24 HRSA, HAB, FAQs on PCNs 15-03 and 15-04, Program Income ¶ 9 (Mar. 21, 2016).
25 45 C.F.R. § 75.439.
26 See 45 C.F.R. §§ 75.318(c), 75.323.
27 45 C.F.R. § 75.2.
28 Id. § 75.307(a).
29 Id. § 75.307(b).
30 Id. § 75.307(e)(2).
31 Id. § 75.305(b)(5).
32 HRSA, HAB, FAQs on PCNs 15-03 and 15-04, Program Income ¶ 4 (Mar. 21, 2016).
33 See, e.g., HRSA, HAB, Letter from Dr. Laura Cheever (Jun 22, 2016).
34 Notice Regarding 340B Drug Pricing Program – Contract Pharmacy Services, 75 Fed. Reg. 10,272 (Mar. 5, 2010)
35 45 C.F.R. § 75.439(b)(2).
36 HHS, Grants Policy Statement at II-57.
37 Id. at II-57 to II-58.
38 See NIH, Grants Policy Statement at IIA-71.
39 See Nation Science Foundation, Research Terms and Conditions Overlay to the Uniform Administrative Requirements, at 35-36 (Mar. 14, 2017).
40 42 U.S.C. § 300ff-26(g); see also HRSA, HAB, PCN 15-04, at https://hab.hrsa.gov/sites/default/files/hab/Global/pcn_15-04_pharmaceutical_rebates.pdf.
41 42 U.S.C. § 256b(a)(4)(J).
42 Id.
43 42 U.S.C. § 300ff-26(f).
44 45 C.F.R. § 75.2 (definition of "Federal financial assistance").
45 31 U.S.C. § 6304 (instructing that agencies should use grant agreements when "the principal purpose of the relationship is to transfer a thing of value to the State or local government or other recipient.").
46 45 C.F.R. § 75.308(e).
47 HHS GPS at II-54 (discussing "significant rebudgeting").
48 45 C.F.R. § 75.101(b)(1).

NASTAD, Washington, DC

On behalf of NASTAD, a leading non-partisan non-profit association that represents public health officials who administer HIV and hepatitis programs in the U.S. and around the world, I appreciate the opportunity to comment on the Health Resources and Services Administration's (HRSA) Request for Information (RFI) pertaining to the HIV/AIDS Bureau (HAB).

We continue to support the Department of Health and Human Services (HHS) in its efforts to reduce reporting burden associated with federal funding for HIV across federal agencies. In the context of rapidly evolving health care and public health systems, health departments are facing increased pressure on already constrained resources — both human and fiscal. Reporting burden continues to divert health department resources and attention away from efforts to support an appropriate and essential public health response, and impedes the program and service integration desired by both health departments and federal partners. Additional reductions coordinated across programs and funding streams are urgently needed.

Recommendations for streamlining reporting requirements associated with the Ryan White HIV/AIDS Program (RWHAP) are presented below. These recommendations seek to reduce reporting burden for health departments, promote consistency across funding streams, eliminate duplication of effort in reporting, and promote program and service integration. With health departments having varying opinions and capacity, we encourage HAB to have continued conversations with grantees on the development and implementation of new policies in these areas.

Powers Pyles Sutter & Verville PC, Washington, DC

Ryan White Clinics for 340B Access (RWC-340B) is a coalition of HIV/AIDS health care providers that receive funding under the Ryan White CARE Act and participate as "covered entities" in the federal 340B drug discount program (340B program). RWC-340B appreciates the opportunity to comment on the Request for Information: Administrative Streamlining and Burden Reduction issued by the Health Resources and Services Administration (HRSA) in May 2018.

Other Issues

RWC-340B would like to take this opportunity to comment on other issues that HRSA should consider as part of its administrative streamlining evaluation.

340B Revenue is Not Program Income

RWC-340B has written twice to HRSA outlining its position that 340B savings are not program income (October 2016 and April 2018). RWC-340B provided detailed arguments in those letters that HRSA's policy that 340B savings are program income is improper. In short, RWC-340B informed HRSA that: 1) 340B savings do not fall within the regulatory definition of program income; 2) HRSA is exceeding its regulatory authority by adopting a polity that 340B savings are program income; and 3) most importantly, HRSA’s policy that 340B savings are program income is harmful to individuals with HIV/AIDS and the mission of the RWHAP. HRSA responded to both of RWC-340B’s letters by stating that it had not changed its position and that 340B savings are program income. Once again, RWC-340B urges HRSA to consider that its policy does not comply with the law and is harmful to the patients that Ryan White clinics seek to serve. RWC-340B would be happy to provide copies of its 2016 and 2018 letters to HAB if HAB would like to refresh its memory about those letters.

HRSA Should Develop More Expansive Policies on the Uses of Program Income

HRSA should relax its policies regarding the permissible uses of program income. Ryan White providers are committed to providing the highest quality of care to HIV/AIDS patients, but HRSA's policies on the allowable uses of program income prevent the provision of necessary services and force Ryan White clinics to adopt practices that are costly to the RWHAP. HRSA should review its restrictions on the use of program income in the context of the National HIV/AIDS Strategy and provide greater flexibility to Ryan White Clinics on the allowable uses of program income.

Purchase of Facilities

HHS regulations governing allowable grant expenditures state that a capital expenditure for a building is not an allowable cost except with the express approval of the grant awarding agency or, for a subgrantee, approval from the grantee. 42 C.F.R. § 75.39(b). While Ryan White grants awarded under Parts A and B are arguably subject to these restrictions by statute, grants provided under other sections of the RWHAP statute are not. This policy results in RWHAP Part C grantees spending exorbitant amount on lease payments rather than investing in real estate purchases that would be less costly to RWHAP in the long term. Although it is possbible theoretically to obtain permission to purchase or construct a building, granting agencies rarely grant this approval in practice. HHS should give project officers greater discretion to allow RWHAP grantees to use program income to purchase buildings or to construct buildings, particularly if the grantee can show that doing so will result in lower expenditures in the long term than lease payments.

Improvements to Facilities

HHS policy on the use of program income to make improvements to facilities is confusing at best. Frequently asked questions issued by HRSA in March 2016 to clarify Policy Notice 2013-1 state that, "Construction and/or major alteration or renovation" is not an allowable use of program income".1

The HHS Grants Policy Statement, however, allows grantees to spend grant funds on "minor" alterations and renovations, subject to certain restrictions.2 Specifically, an HHS grantee may spend the lesser of $150,000 or 25% of its program budget on alterations and renovations.3 The HHS Grants Policy Statement also provides that the alterations and renovations must be "essential" to the purpose of the grant and that the renovated space must be occupied by the project or program.4

The HHS Grants Policy Statement states that if an alteration or renovation is considered "modernization," it is not a minor activity, no matter what its costs, and is not allowable unless there is specific statutory authority.5 The HHS Grants Policy Statement does not, however, include a clear distinction between "modernization" and "alteration or renovation."6 Therefore, grantees are without clear policy guidance as to the type of changes that would be considered modernization.

The perplexing guidance described above leaves RWHAP grantees without clear guidance on whether they can make improvements to facilities. Is upgrading a facility so that it is more readily accessible for disable individuals a permissible alteration or renovation or is it an impermissible "modernization"? HRSA should give project officers greater discretion to allow RHWAP grantees to use program income to modernize and upgrade facility.

Other Services

HRSA Policy Notice 16-02 sets out the types of services that RWHAP providers may furnish to their patients. While HRSA has stated that a RWHAP provider may use program income to furnish any type of service that is permissible under its grant category regardless of whether that service is permitted under that provider’s grant, HRSA should allow additional flexibility to RWHAP providers on the types of services that they can furnish.

Currently, RWHAP providers cannot use program income to provide services such as long-term child care for children of their HIV/AIDS patients. Nor can they use program income to provide services to uninfected partners of their HIV/AIDS patients, even though doing so might result in better adherence from the HIV/AIDS patient. HRSA should consider that Ryan White clinics are in the best position to assess the needs of their patients and should be granted additional flexibility to provide needed services to their patients.


1 Available at: https://hab.hrsa.gov/sites/default/files/hab/Global/faq15031504.pdf
2 HHS Grants Policy Statement, p. II-30; see also 45 CFR § 75.462.
3 Id.
4 Id.
5 Id.
6 The Grants Policy Statement states that modernization may include "alteration, renovation, remodeling, improvement, expansion, or repair; provision of equipment necessary to make the building suitable for use by a particular program; and the modernization, or completion, of shell space." Grants Policy Statement at II – 98. Notably, this definition includes the terms "alternation" and "renovation" and the definition of "alteration and renovation" (above) includes the term "modernization." Therefore, the Grants Policy Statement does not provide clear guidance on how to distinguish "alternative and renovation" from "modernization."

New York City Department of Health and Mental Hygiene, Queens, NY

The New York City Department of Health and Mental Hygiene (Health Department) appreciates the opportunity to comment on Health Resources and Services Administration (HRSA)'s "Request for Information: Administrative Streamlining and Burden Reduction," announced May 1, 2018. The Health Department commends HRSA’s efforts to reduce public and stakeholder burden in complying with administrative and reporting requirements, and appreciates the opportunity to comment on its proposed changes to waiver application, data reporting, and eligibility screening requirements under the HIV/AIDS Bureau (HAB)'s Ryan White program.

The Health Department is the largest public health department in the United States, with more than 6,000 employees serving 8.4 million New Yorkers from a diverse array of ethnic, cultural, and economic backgrounds. The Health Department coordinates the City's response to the HIV epidemic, including prevention, care and treatment, and surveillance efforts. The Health Department serves as the grantee for the Ryan White Part A program for the New York Eligible Metropolitan Area, which includes New York City and Putnam, Rockland, and Westchester Counties; New York’s grant is the largest Ryan White Part A grant in the country, with a total award of $101,129,828 for 2016.

Regional Center for Infectious Disease, Cone Health Medical Group, Greensboro, NC

Dr Cheever

As always it was a pleasure to visit with you with the Ryan White Medical Providers Part C steering committee this spring.

in asking for comments about reduction of burden several points come forward.

  1. the biannual re-application for Ryan White and ADAP is overly burdensome on our staff and our patients.
  2. our clinic is fortunate enough to get funding via sub-contracts from Part B/C/D.
    Unfortunately this means we also have to report multiple times. I am hoping that this proves can be streamlined.
  3. please do not close the AETCs. They are an incredible resource for training staff.

thank you for this opportunity to comment and your commitment to excellence in HIV care best wishes.

SFDPH - HIV Health Services, San Francisco, CA

In the context of rapidly changing health care and public health systems, health departments are facing increased pressures on already constrained resources – both human and fiscal. San Francisco appreciates the opportunity to respond to the Request for Information (RFI) on reducing burden to create a streamlined, flexible, and less burdensome compliance and reporting structure for recipients of Ryan White funding.

St. John's Riverside Hospital, Yonkers, NY

Dr. Sigounas,

The undersigned Ryan White HIV/AIDS Program ("RWHAP")-funded clinic greatly appreciates this opportunity to provide the Health Resources and Services Administration ("HRSA") and its HIV/ AIDS Bureau ("HAB") with feedback on how HAB can streamline guidance to reduce administrative burdens, eliminate inconsistencies with statutory authorities,and otherwise improve the RWHAP without affecting the agency's ability to perform adequate oversight.

Please consider our comments as you review possible deregulatory actions to take in response to Executive Order 13771 and the Office of Management and Budget's Final Bulletin for Agency Good Guidance Practices.

Clarifying Patient Income Requirements and the Payer of Last Resort Standard

Comment 1: Correct Existing Guidance That Misrepresents the RWHAP's Low-Income Protections

The RWHAP statute contains protections for low-income PLWHA, but the program is not limited to low-income individuals. HRSA should correct guidance that implies otherwise, while encouraging grantees to ensure that all low-income patient needs are met before applying resources to higher-income individuals.

The Issue

The RWHAP statute prohibits the imposition of charges on individuals with an income less than or equal to 100 percent of the federal poverty line ("FPL"), and caps the total annual charges for individuals with incomes above 100 percent of the FPL.1 RWHAP contains further protections for low-income individuals through the "payer of last resort" provision (discussed in more detail in Comment 2, below).

However, the RWHAP statute does not limit program eligibility to only low-income individuals. In fact, the statute makes clear that all PLWHA are potentially eligible for some or all services. In particular, it requires that Part A and Part B grantees to "furnish services without regard to the ability of a patient to pay."2 Moreover, it provides for no upper cap in requiring that the maximum annual amount that a RWHAP-funded clinic may charge a patient whose income is above 300% of the FPL is 10% of his or her annual income.3

Yet Policy Clarification Notice ("PCN") 13-02 states that "[t]he RWHAP legislation requires that individuals receiving services through the RWHAP must have a diagnosis of HIV/AIDS and be low-income as defined by the RWHAP grantee."4 The restriction that RWHAP program service eligibility is limited to low-income individuals seems to have been read into the law, but it never appears there.

Later guidance, including PCN 16-02, describes "eligible individuals" in some detail without referencing any expectation that all recipients of RWHAP-funded services would be below a certain income threshold.5 PCN 13-05 describes premium assistance as a possible service to individuals with incomes as high as 400% of the FPL or greater.6

PCN 13-02's stated limitation that to be an eligible beneficiary a person must be low-income adds (without authority and in a manner directly conflicting with the RWHAP statute) a new legal requirement to the R WHAP program through subregulatory guidance. The limitation creates unnecessary burden on the ability of grantees to structure programs that will be most effective for meeting the RWHAP's purpose of"provid[ing] for the development, organization, coordination and operation of more effective and cost-efficient sr5tems for the delivery of essential services to individuals and families with HIV disease."7

Negative Impact of the Guidance

The RWHAP authorizes recipients to provide many core medical and support services that have proven highly effective for treating PLWHA, but which are rarely reimbursed by traditional health insurance. These so-called "wrap-around" services benefit PLWHA regardless of their income, and facilitate the linkage, retention, therapy, and viral suppression numbers seen in RWHAP-funded clinics. Depriving an individual of those services does a disservice to the broader PLWHA community.

In addition, PLWHA might not stay in a specific income band. Many RWHAP services are most effective when they are provided continuously, and not when they are started and stopped due to income fluctuations. The implementation of income-based limitation guidance that is inconsistent with the RWHAP statute places grantees in the untenable position of having to potentially deny (at risk of a program finding or HAB-initiated disallowance) statutorily authorized benefits on the basis of inconsistent sub-regulatory guidance, placing them at risk of disputes with potential beneficiaries, subrecipients and subcontractors.

Suggested Solution

Under the RWHAP statute, the decision to prioritize particular services to low-income individuals appears intended to be left to the discretion of the grantee. RWHAP guidance should confirm this statutory intent, but not imply that RWHAP resources may never be allocated to individuals who earn more than 300%, 400%, or some other arbitrary income ceiling.

The RWHAP statute contains support for the prioritization of resources in such a manner. For Parts A and B, the statute requires the grantee's application to include assurances that the grantee will (i) "ensure [RWHAP] services will be provided in a setting that is accessible to low-income individuals with HIV/AIDS ... and (ii) "provide outreach to low-income individuals with HIV/AIDS."8 Similarly, for State-administered programs under Part B that offer "Continuum of Health Insurance Coverage" services, such services are to be targeted at individuals who could not otherwise afford the coverage, and grantees are to set eligibility criteria.9 This requirement both furthers the point that the statute does not limit beneficiaries to low-income individuals and the point that the statutory scheme is designed to afford grantees flexibility on a service-by-service basis, so long as assistance to low-income individuals is prioritized.

For the reasons stated above, we request that PCNs 13-02 and 16-02 (and other RWHAP guidance as necessary)10 be corrected and/or clarified to indicate that income thresholds for eligibility may be set by the grantee at any level (or, when appropriate, not applied at all), so long as the grantee ensures its services are made available to low-income individuals.

Comment 2: Clarify the Application of the RWHAP Payer of Last Resort Requirement to Non-Health Care Services and Situations in Which RWHAP Is Not Acting as a Payer

The RWHAP "payer of last resort" expectations lead to confusion among RWHAP providers. Due to some overbroad HAB guidance, some providers will only provide RWHAP resources to the uninsured, or will not provide support services if similar services are available in the community. HAB should clarify its existing guidance and amplify guidance that explains that RWHAP resources may be used to fill gaps in health care services and may be used to provide support services regardless of an individual's health coverage.

The Issue

The RWHAP "payer of last resort" restriction appears in RWHAP Parts A, B, and C. In Part A, the provision states that RWHAP funds may not be utilized:

to make payments for any item or service to the extent that payment has been made, or can reasonably be expected to be made, with respect to that item or service—(A) under any State compensation program, under an insurance policy, or under any Federal or State health benefits program (except for a program administered by or providing the services of the Indian Health Service); or (B) by an entity that provides health services on a prepaid basis.11

Though the statutory limitation applies only to payments made under state compensation programs, insurance policies, and federal or state health benefits programs, HAB guidance states that RWHAP funds cannot be used to pay the cost of a service where any other funding is available.12 Additionally, for RWHAP Part C, the limitation is applied by the statute only to EIS services;13 and for RWHAP Part D the limitation (to the questionable extent it might be construed as a limitation under its wording) is stated only in reference to "primary care services."14

Negative Impact of the Guidance

First, HAB's overly broad guidance on the payer of last resort provision has potential to be erroneously construed to mean that RWHAP-funded services may only be provided to PLWHA who lack health insurance. That misconception unnecessarily limits the ability of the provider to render needed support services to PLWHA.

Further, though the statute only requires certain listed types of funding be sought and/or applied before RWHAP funds may be used to provide services for PLWHA, HAB's guidance implies any and all funding or payment sources other than RWHAP funds must first be exhausted. Of particular importance are federal non-healthcare sources of funding (which the statute does not mention). For example, HAB guidance implies that a grantee that receives HOPWA funding could not use RWHAP funding to support housing services without first exhausting all available HOPWA funds. Such rules make proper allocation of expenses under the federal costs principles unnecessarily complicated.

Suggested Solution

RWHAP guidance should be clarified to more closely follow the actual limited statutory restriction. HAB should clarify that while RWHAP providers may not use RWHAP funds when another healthcare funding source is available, they may use RWHAP funds to provide support services (regardless of whether other funding sources may be available to provide support for those services). HAB should emphasize guidance that indicates that RWHAP resources may be applied to healthcare services "not covered, or partially covered, by public or private health insurance plans."15 We appreciate that HAB made that point in recently released Policy Clarification Notice 18-01.

HAB might also wish to reemphasize that, irrespective of the payer of last resort provision, the Uniform Administrative Requirements at Part 75 of Title 45 of the Code of Federal Regulations contain expenditure control and budget mechanisms in the form of the Cost Principles at Subpart E.

Eliminating Unnecessary Restrictions on Program Income Calculation and Expenditures

Comment 3: HAB's Blanket Prohibition on Construction Costs for RWHAP Parts C and D Is Incorrect and Is Harmful to Grantees, Beneficiaries, and the RWHAP Program.

Many providers funded under Parts C and D of the RWHAP are utilizing outdated and cramped facilities. Some have the potential to generate sufficient resources to fund construction or major renovation of their facilities, but HAB has imposed a blanket prohibition on construction costs. That prohibition is not supported by the statute to the extent applied, and should be revised to reflect the actual scope of the statutory limitation.

The Issue

HAB has stated repeatedly that construction activities are prohibited by the RWHAP statute. For Parts A and B, the RWHAP statute provides that grant recipients may not use "amounts received under a grant" awarded under Parts A or B to "purchase or improve land, or to purchase, construct, or permanently improve (other than minor remodeling) any building or other facility."16 Those prohibitions do not appear in Parts C and D. However, multiple HAB issuances have extended the prohibition to Parts C and D.

For example, in the Frequently Asked Questions ("FAQs") issued by HAB on March 21, 2016 to interpret PCNs 15-03 and 15-04, HAB described "[c]onstruction and/or major alteration or renovation" as a specific example of a cost toward which a grantee may not afply program income (as defined in 45 C.F.R. § 75.2 and discussed in more detail below).17 In an April 2016 FAQ document issued specifically for RWHAP Parts C and D, HAB's Division of Community HIV/ AIDS Programs wrote:

4. Can 340B program income be used for building new facilities?

No. Construction is an unallowable expense under the RWHAP, includinf: Part C and Part D. Consequently, program income may not be used for construction. 18

The FAQ repeats the statement in its paragraph 17, stating that "those costs that are expressly articulated by statute as being unallowable, including construction..., may not be funded by program income."19

In the OMB Compliance Supplement, the support cited for this restriction for Part C funds (CFDA 93.918) is 42 U.S.C. § 300ff-64(g)(l). Subsection 300ff-64(g)(l) provides merely a general statement that the applicant must agree that it "will not expend amounts received under this part [i.e., RWHAP Part C] for any purpose other than the purposes described in [Part C]." That general sentiment appears in Parts A and B as well,20 yet in those areas Congress still felt the need to specify that construction is not an allowable cost.

Agencies must presume that Congress "says in a statute what it means and means in a statute what it says."21 The absence of the construction prohibition in the language of Parts C and D indicates that Congress intended to authorize such activities for Part C and D grants, not prohibit them. Also, the Supreme Court has said that statutes must be read so as to avoid interpreting "a statutory provision so as to render superfluous other provisions in the same enactment."22 If the general limitation on the use of RWHAP funds for core medical services, support services, and administrative expenses appears in Parts A, B, and C, and Congress felt the need to specify that construction costs are not allowed in Parts A and B, we must presume that Congress intended to permit construction costs under Part C. HAB cannot impose a new funding condition, because Congress, and not the executive branch, sets funding conditions.23

While program income is subject to a federal interest and subject to certain of the same terms and conditions as the federal funds, HAB can authorize broader use of program income than it can grant funds. For example, HAB has explained in the HAB FAQ issuance for PCNs 15-03 and 15-04 that the internal thresholds for certain types of expenditures such as the 75 percent core medical services threshold, 50 percent early intervention services ("EIS") threshold, and 10 percent administrative cost cap do not apply to program income.24

Moreover, to remove this unsupported limitation would not remove HAB's authority to exercise judgment in authorizing construction-type activities under RHWAP Parts C and D, as the federal cost principles require express prior approval all capital expenditures funded with federal grant funds.25

Negative Impact of the Guidance

Some RWHAP Part C providers have the resources, primarily in the form of program income, to fund much-needed construction and renovation projects. Due to the stated application of a construction prohibition to Part C, those providers are forced to waste program income on renting unsuitable space or are unable to provide services to their full potential due to existing space and facility limitations.

Moreover, were HAB to authorize the use of RWHAP Parts C and D funds, or RWHAP Part C or D program income for such purposes, the RWHAP program would benefit from the long term federal interest investment in the property.26 Currently, RHWAP recipients are forced to rent facilities, with long term benefits instead accruing to their landlords.

Suggested Solution

HAB should permit Part C and D providers to propose construction projects, and should approve the projects when appropriate. In particular, HAB should exercise its authority to permit application of program income for such purposes to enable investments in the RWHAP program that benefit the program, the grantees, and the beneficiaries over the long term.

Comment 4: Waive Prior Approval Requirements for Special Purpose Equipment Purchases under $25,000 and Program Income Expenditures

RWHAP grantees and subgrantees often must wait months to obtain approval for expenditures for which prior approval is not required in other programs. HAB should waive prior approval requirements for equipment purchases that cost less than $25,000 and for program income expenditures.

The Issue

Capital expenditures for special purpose equipment purchases in excess of $5,000 typically require the prior written approval of the awarding agency or pass-through entity.27 Agencies within HHS, however, have expanded authority under the HHS Grants Policy Statement to waive certain prior approval requirements.28 Agencies have the authority to waive cost-related prior approvals for direct cost items, including equipment, except when the purchase would result in a change of scope.29

Negative Impact of the Lack of Guidance

RWHAP grantees and subgrantees go months without needed equipment because the approval process is time-consuming.

Suggested Solution

HRSA should waive prior approval requirements for special purpose equipment purchases of less than $25,000, when program income is being used rather than grant funds. Such a $25,000 threshold for equipment purchases is common within federal grant programs. For example, it is applied under the National Institutes of Health ("NIH") Grants Policy Statement.30 The government-wide standard research terms and conditions administered by the National Science Foundation ("NSF").31

Other Issues

Comment 5: Eliminating Requirements to Budget Personnel by Specific Name as Opposed to Merely Position and FTE.

The Issue

HAB requires grantees to provide specific provider names in their budget justifications, implying that those specific individuals are the only individuals for whose salaries and wages RWHAP funds should be used. Some state and municipal passthrough entities ("PTEs") require budgeting by individual named providers, insisting that only the salary and fringe costs of those specific individuals are allowable. HAB should clarify that its budget justifications should not be construed as creating any binding obligation that the grantee pay for the specific individuals listed in the budget justification with RWHAP funds, and that PTEs should impose no such requirement. The Uniform Guidance32 and Department of Health and Human Services Grants Policy Statement ("GPS")33 provide, when read together, that so long as the grantee does transfer, between budget categories, funds in excess of twenty five percent (25%) of the total approved budget, no approval of the awarding agency is required. Moreover, the Uniform Guidance requires that this flexibility be flowed down to subrecipients by PTEs.34

Negative Impact of the Guidance (and Lack of Guidance)

Often, RWHAP grantees allocate costs and develop budgets on an FTE basis without regard to who individual providers are (for example, historical data may show that 0.7 FTE registered nurses are needed, but that 0.7 FTE is comprised of the combined periodic effort of a pool of four different individuals). It is simply not feasible for many entities to employ providers dedicated to furnishing services only to HIV-positive individuals, and it is rarely the most economical approach to employing providers. When HAB implies, and PTEs require, budgeting by individuals, grantee operations are greatly impacted; requiring either (i) unusual and inefficient staffing patterns, or (ii) use of specifically named individuals as mere "placeholders" with the hope that such use of individuals as placeholders is not later construed by a PTE as a misrepresentation by the subrecipient.

Suggested Solution

Issue guidance clarifying that HAB does not require, and PTEs may not require, budgeting by specific named individuals, in HAB FOAs and its Part A and B manuals.

Comment 6: Suspend Changes to RSR Expenditure Reporting and Reduce Eligibility Recertification to Once Annually

The RFI requests feedback specific proposals for (i) additional and more detailed Ryan White Services Report ("RSR") submissions; and (ii) ways in which the semiannual eligibility recertification process burden can be reduced.

The Issue

In City's and state's where the state funded HIV programs require use of other databases than Care Ware and which do not build these calculations into the required databases (such as New York City and State), RSR Expenditure reporting will be onerous.

Programs with income (for example, Part C) are already required to generate a listing of program expenditures prior to voucher for federal funds. In addition, they generate backup of expenditure of their income for their notation on the annual FSR that program funds were used in accordance with the stated guidelines. To add yet another requirement to provide this information is duplicative and a time burden on grantees.

In addition, clients incomes do not change significantly over the course of a year. We respectfully request that a consideration be made of only requiring annual eligibility recertification to reduce the paperwork and burden on grantees and clients alike.

Suggested Solution

Refrain from requiring additional RSR reporting on expenditures. Pare recertification back to once annually.


1  42 U.S.C. §§ 300fT-15(e); 300fT-27(c); 300ff-64(e).
2  42 U.S.C. §§ 300ff-15(a)(7)(A)(i) (Part A) and 300ff-27(b)(7)(B)(i) (Part B).
3  42 U.S.C. §§ 300ff-l5(e)(I)(C) (Part A), 300fT-27(c)(I)(E)(Part B), and 300ff-64(e)(2)(C) (Part C).
4  HRSA, HAB, Policy Clarification Notice ("PCN") 13-02 at I.
5  HRSA, HAB, PCN 16-02 at 2-3.
6  HRSA, HAB, PCN 13-05 at 5.
7  42 U.S.C. § 300ff.
8  Id. §§ 300ff-l 5(a)(7)(BH C) (Part A), 300ff-27(b)(7)(B)(ii–iii) (Part B).
9  Id. § 300ff-27(b)(7)(B)(iv).
10 Other pertinent guidance may include, but would not necessarily be limited to, the RWHAP Part A and B Manuals, Site Visit Guides, and the 0MB Subpart F Audit Compliance Supplement for RWHAP programs.
11 42 U.S.C. § 300ff-15(a)(6) (limitation as stated in Part A); see also §§ 300ff-27(b)(7)(F) (nearly identical language for Part B ), 300ff-64(f)(I) ( identical language for Part C); 300ff-71 (i) ("Nothing in this part shall be construed as requiring funds under this part be used for primary care services when payments are available for such services from other sources (including under titles XVIII [Medicare], XIX [Medicaid], and XXI of the Social Security Act).").
12 See, e.g., RWHAP Part A Manual at 33 ("By statute, the RWHAP funds may not be used for any item or service 'for which payment has been made or can reasonably be expected to be made' by another payment source..." (emphasis added)); Part B Manual at 63 (identical language to the Part A Manual); HRSA, HAB, PCN 10-02 at 2 ("The RWHAP statute, codified at title XXVI of the Public Health Service Act, stipulates that 'funds received ... will not be utilized to make payments for any item or service to the extent that payment has been made, or can reasonably be expected to be made...' by another payment source." (emphasis added)); HRSA, HAB, PCN 13-02 at I ("By statute, RWHAP funds may not be used for any item or service 'for which payment has been made or can reasonably be expected to be made' by another payment source..." (emphasis added)); HRSA, HAB, PCN 13-05 at I (identical language to PCN 13-02);
13 42 U.S.C. § 300ff-64(f).
14 42 U.S.C. § 300ff-71(i).
15 HRSA, HAB, PCN 13-03 at 2.
16 42 U.S.C. §§ 300ff-14(i) (construction prohibition for Part A funds); 300ff-22(f) (construction prohibition for Part B funds).
17 HRSA, HAB, FAQ on PCNs 15-03 and 15-04 (Mar. 21, 2016), ¶ 4, at https://hab.hrsa.gov/sites/default/files/hab/Global/faq15031504.pdf.
18 HRSA, HAB, Parts C/D FAQ on Program Income/Maintenance of Effort (April 2016), ¶ 4, at https://careacttarget.org/sites/default/files/supporting-files/FINAL_DCHAP%20Program%20Income%20FAQ_051016.pdf. HRSA Exit Disclaimer
19 Id., ¶17.
20 42 U.S.C. §§ 300ff-14(a)( I )(2) (Part A – "The Secretary may not make a grant... unless such political subdivision agrees that... funds provided under [Part A] will be expended only for ... [core medical services, support services, and administrative expenses."), 300ff-22(a) (Part B – "A State may use amounts provided under grants made under [Part B] for (core medical services, support services, and administrative expenses.")
21 Conn, Nat. Bank v, Germain, 503 U.S. 249, 254 (1992).
22Pa. Dept. of Pub. Welfare & Dev. v. Davenport, 495 U.S. 552,562 (1990).
23 See, e.g., South Dakota v. Dole, 483 U.S. 203 (1987).
24 HRSA, HAB, FAQs on PCNs 15-03 and 15-04, Program Income ¶ 9 (Mar. 21, 2016).
25 45 C.F.R. § 75.439.
26 See 45 C.F.R. §§ 75.31 S(c), 75.323.
27 45 C.F.R. § 75.439(b)(2).
28 HHS, Grants Policy Statement at II-57.
29 Id. at II-57 to II-58.
30 See NIH, Grants Policy Statement at IIA-71.
31 See Nation Science Foundation, Research Terms and Conditions Overlay to the Uniform Administrative Requirements, at 35-36 (Mar. 14, 2017).
32 45 C.F.R. § 75.308(e).
33 HHS GPS at II-54 (discussing "significant rebudgeting").
34 45 C.F.R. § 75.101(b)(1).

Texas Health Action, Austin, TX

Ryan White Part C grantee eligibility should include STD clinics as they take an increasing role in testing and diagnosing HIV as part of PrEP services for prevention and rapid linking to care.

Part C Early Intervention Services should support PrEP services including the rapid linkage to care where patients are diagnosed or work to keep them on PrEP.

6 month patient/individual re-certification process should include a grace period that allows an agency/provider to re-certify within 30 days of the 6 month re-certification deadline. Moving to longer periods will keep people in care longer and reduce the burden on local providers as well as States in paperwork and systems.

RFI section C.1

AIDS United, Washington, DC (Legacy Community Health)

In an effort to respond to HRSA's request for recommendations on changes to regulations or guidance that could reduce burden and increase efficiencies for grant recipients, Legacy has provided the specific recommendations below:

Suggestion #1 for HAB: Allow greater flexibility for the use of 340B savings: Allowing greater flexibility in areas specifically related to the mission of HIV service organizations would significantly improve the services of HIV organizations and agencies. HRSA and Congress should clarify that Program Income from the 340B Drug Discount Program be acceptable for uses that comport with section 330 grantees (Federally Qualified Health Centers) and/or specifically functions within subgrantee operations to support health and end the HIV epidemic. Such common uses include: HIV Prevention services including Pre-Exposure Prophylaxis (PrEP); funding for Sexually Transmitted Infections (STI) prevention services; construction of accommodations to benefit patients; and reasonable reserve funding (6 months) for use when regular income is disrupted or reduced in order for typical operations to continue.

Suggestion #2 for HAB: Remove HAB's prohibition on construction costs for Ryan White HIV/AIDS Program (RWRAP) Parts C and D: It would benefit patients if HAB allowed Part C and D providers to propose construction projects, and approve the projects when appropriate. In particular, HAB should exercise its authority to allow the application of program income for such purposes to enable investments in the RWHAP program that benefit the program, the grantees, and the beneficiaries over the long term.

Boston Public Health Commission, Boston, MA

The Core Waiver requires supporting documentation that could be requested more efficiently.

For example, letters from state ADAP programs regarding waitlists could be requested directly by HRSA annually from state providers. For states that do not have a waitlist, EMAs in those jurisdictions could automatically be excluded from requesting a waiver. Requiring Part A programs to request letters from state partners adds an additional step.

Secondly, the application requires evidence of a public process, which is already described in each year’s grant application where EMAs discuss priority setting and resource allocation by the Planning Council.

Lastly, expenditures are submitted through the electronic handbook, which calculates core and support allocations. Require a resubmission of this information through the waiver process is redundant.

CAEAR Coalition, Washington, DC

The Core Medical Services Waiver process as outlined in PCN 13-07 is overly complicated and should be streamlined. In particular, much of the information provided does not change significantly, if at all, year-to-year and some of it even comes directly from HRSA's Data Warehouse. The option to submit a certification that there has been no change, even in alternating years, would reduce burden significantly. Or, since much of the discussion of the decision to allocate the less than 75% to core medical services is explained throughout the grant, including the planning council section and the resource inventory, it also seems like the addition of a letter from Medicaid and ADAP Director to the attachments, would also suffice to meet the requirements of the waiver in the annual application.

California Department of Public Health, Sacramento, CA

  • Rather than requiring recipients to submit a ten-page waiver request, HAB should develop a standardized form with pertinent data and narrative questions for recipients to complete and submit for consideration of a waiver; similar to how recipients demonstrate the need for a Women, Infants, Children, and Youth (WICY) Waiver. Such a form would ensure that all recipients requesting a waiver provide uniform information to HAB so that they can make their decisions. Use of a form would also reduce recipients' administrative burden writing a ten-page narrative request.
  • The overall time spent on data collection only for our state is estimated to be 45 hours each time we apply for a waiver.
  • It is a challenge to know if clients can access services in 30 days. We use other data as a proxy to show what we believe is proof that the services are available. Data includes surveillance data and Ryan White Services Report (RSR) data showing the time from diagnosis to first lab and viral load suppression.
  • It is unrealistic for HAB to assume larger states will have client utilization data outside of the RSR.
  • As of December 2017, 83% of Medicaid participants in our state are on a managed care plan. Getting data from these plans is starting but is still a challenge. We use Fee-for-Service data but that is not as helpful now that so many participants are covered under a managed care plan.
  • It would be helpful if HAB could use data from statewide continuum of care data as all States will have that data and HAB can see improvements from year to year.

California Primary Care Association (CPCA), Sacramento, CA

CPCA members have expressed support for the 75/25 requirement as a way to regulate and ensure the proper use of these critical Ryan White funds. We do, however, believe that HRSA should reduce the documentation necessary to request a waiver. Specifically, HRSA should consider reducing narrative length and number of required support letters.

C​ommonwealth of Kentucky HIV/AIDS Branch, Frankfort, KY

Under RFI C.1 on the 75% rules I try to monitor the expenditures to ensure we spend the 75% as required and most all of the time we spend the required 75% and more.

Community Clinic Association of Los Angeles County (CCALAC), Los Angeles, CA

Health centers in California have expressed support for the 75/25 requirement as a way to regulate and ensure the proper use of these critical Ryan White funds. They also support reducing the documentation necessary to request a waiver, possibly by reducing narrative length and number of required support letters.

Department of State Health Services, Texas Part B, Austin, TX

Not applicable for Texas Part B.

Family Health Centers of San Diego, San Diego, CA

Family Health Centers of San Diego has never requested the waiver. The County of San Diego does apply for the waiver each year. While we have not heard that the content and documentation is overly burdensome, that question would have to be answered by the County of San Diego as the primary grantee. It is our belief that until it is generally accepted that the Ryan White wrap-around services are THE reason that Ryan White patients have much higher rates of viral suppression than non-Ryan White patients, we feel the requirements should remain as they exist today in order to provide adequate justification to congress and the administration of the need for Ryan White program funding.

Grady Health System Infectious Disease Program, Atlanta, GA

The Core Medical Services Waiver process as outlined in PCN 13-07 is indeed overly complicated and could be streamlined. In particular, much of the information provided does not change significantly, if at all, year-to-year and some of it even comes directly from HRSA Data Warehouse. The option to submit a certification that there has been no change, even in alternating years, would reduce burden significantly. Or, since much of the discussion of the decision to allocate the less than 75% to core medical services is explained throughout the grant, including the planning council section and the resource inventory, it also seems like the addition of a letter from Medicaid and ADAP Director to the attachments, would also suffice to meet the requirements of the waiver in the annual application.

HIV Medicine Association (HIVMA), Arlington, VA

Regarding HRSA's HIV/AIDS Bureau's (HAB) process to obtain a waiver for the requirement that jurisdictions spend at least 75% of their funds on core medical services, HIVMA and RWMPC are unaware of jurisdictions experiencing difficulty with the current waiver process and have heard that jurisdictions are able to obtain waivers in a timely fashion. HIVMA and RWMPC urge HRSA/HAB to continue the current waiver process.

Massachusetts Department of Public Health, Boston, MA

Core Medical Services Waivers — No feedback since we have not had to request this type of waiver. However, our Ryan White Part A colleagues have submitted the waiver and reported that it was burdensome.

Mendocino Community Health Clinic (MCHC), Ukiah, CA

MCHC supports the 75/25 requirement as a way to regulate and ensure the proper use of these critical Ryan White funds. We do, however, believe that HRSA should reduce the documentation necessary to request a waiver. Specifically, HRSA should consider reducing narrative length and number of required support letters.

NASTAD, Washington, DC

While health departments commend the improvements HAB has made to the 75/25 waiver request process and associated application requirements, there is still substantial duplication of content of information related to the waiver request within a project period. Jurisdictions must be able to adapt and tailor their funding to fit their epidemic and care needs of their most affected populations.

The 75/25 waiver request represents an area of substantial opportunity for reducing reporting burden and improving health outcomes for people living with HIV (PLWH). NASTAD believes the 75/25 waiver request must be more fully incorporated into the Part A and B application which would allow the deletion of several sections of the current wavier request. In addition, HAB already has information and data from several sections required under the waiver process from other grant submissions. The Needs Assessment and Unmet Need section should not be required again, as it has already been submitted. In addition, many of the narrative sections requested are discussed in applications and continuation submissions. The requirement to certify that there are no ADAP waiting lists is unnecessary and onerous at this point in the program and HAB is already aware of the fiscal health and services provided by all ADAPs. NASTAD has heard of jurisdictions who must go back and forth several times with their HAB project officer clarifying and providing additional information, almost all of which has been provided to HAB in previous grant submissions or project officer interactions. Eliminating and streamling questions for this request will provide receipients more time to implement programs.

New York City Department of Health and Mental Hygiene, Queens, NY

The Core Medical Services Waiver process as outlined in PCN 13-07 is overly complicated. Most of the information HRSA requires for waiver applications changes little, if at all, from year to year; also, some of the information included in the application comes directly from the HRSA Data Warehouse. To significantly reduce applicant burden, the Health Department suggests that instead of requiring applicants to submit a waiver application each year, HRSA offer the option to submit a certification in alternating years that there has been no change. Alternatively, the Health Department suggests that HRSA consider allowing letters from Medicaid and the AIDS Drug Assistance Program (ADAP) to substitute for the current waiver application requirements, since much of the reasoning as to whether to allocate less than 75% to core medical services appears throughout the grant application, including the planning council section and the resource inventory.

Public Health – Seattle & King County, Seattle, WA

We are grateful for the opportunity to have the Core Medical Services requirement waived. The requirements for requesting a waiver are reasonable not burdensome for the first year of the waiver, but in subsequent years, when there has been no change, the need to submit all content for the original waiver seems redundant. Perhaps HAB could consider extending the waiver until such time as the jurisdiction determines, through their needs assessment process, that a waiver is unwarranted. Or, like the WICY waiver, the jurisdiction could merely provide the resource inventory chart as the sole document required to continue the waiver in subsequent years.

SFDPH - HIV Health Services, San Francisco, CA

2018 will be the fifth consecutive year that San Francisco will have engaged the Core Medical Services Waiver process as outlined in the HIV/AIDS Bureau’s Policy Clarification Notice (PCN) 13-07. The application for the Waiver has amounted to over 150 pages of information in each of those years, though much of that information does not change significantly from year to year. Some tasks required with the Waiver application are particularly labor intensive, such as performing a comprehensive review and update of the inventory of HIV resources in the jurisdiction, including funding information. The planning council and resource inventory sections of the annual grant application contain much of the justification for the local decision to allocate less than 75% to core medical services. California has 8 Part A jurisdictions, and all of those jurisdictions that seek a waiver will need to obtain and report the same letter from the State Office of AIDS that indicates there is no wait-list for the state-managed ADAP. This would seem a clear case of duplication. Serious consideration should be given as to whether the waiver needs to be an annual application, or whether once the waiver is approved, subsequent applications might have significantly reduced amount of documentation required. Ideally, a short form stating that an EMA/TGA has received and is again requesting said waiver with no impactful changes to information previously submitted. Instead of reporting details of program income, the burden for large EMAs could be substantially reduced if the broad commitment of local funds to offset client costs could be demonstrated.

Waterloo Counseling Center, Austin, TX

"c. Letters from Medicaid and other State and local HIV/AIDS entitlement and benefits programs, which may include private insurers."

I am not sure why this is necessary. It would definitely cause an undue burden, especially when dealing with private insurers who have no sense of urgency in helping move on a waiver. This should be removed for expediency.

WV Bureau for Public Health, Charleston, WV

The current process to request a waiver is very complicated. WV recommends that waiver request documentation be limited to a statement from the state Ryan White Part B/ADAP Director that describes how the approval of a waiver will positively contribute to the ability to address service needs for non-core services and a statement that no waiting list exists and that services will be available and accessible within 30 days for all eligible individuals. The previously submitted RSR should suffice as supporting documentation related to the request.

RFI section C.2

Comments from General Public

Comment #1

I think that for our health center most of our patients meet the threshold of eligibility for RSR reporting since. I think for an agency of our size with our population type it would not be burdensome. For larger entities who serve a lot of people who do not use Grant funds it could be a burden.

Comment #2

This would be incredibly burdensome for the providers and raises a number of issues: 1 – HAB does NOT have authority over rebate dollars – OMB staff have clearly stated that an FAQ is not a legally binding or enforceable document. Rebate dollars have not been sufficiently documented to be program income and therefore reporting on them is also not in HAB's authority. As late as 2017 the House and Energy Committee clearly stated:

Screenshot from House Energy & Commerce Report showing excerpt from the Review of the 340B Drug Pricing Program

What areas HRSA had regulatory authority over. Finally many funds come from Private grantees, foundations and even pharmaceutical companies. These funders require their own reporting for the grant dollars given. Will HRSA ask for dual reporting on items they have no right to have ? How do you allow for “client level data when you are not the funder ?? Medicaid insurers have no right to client information unless they are paying for the service – what rights have you ?

AIDS Institute - New York State Department of Health, Bronx, NY

The intent of this RFI is to seek public comment on "Administrative Streamlining and Burden Reduction". However, the proposal to change the Ryan White Services Report (RSR) client-level reporting to include eligible clients who receive RWHAP allowable services that were funded using RWHAP and RWHAP-related funding will increase the administrative and reporting burden on grant recipients and sub-grant recipients.

Expanding the scope of the RSR reporting requirement to include RWHAP-related funding will increase the number of eligible clients included in the RSR. While this might be the intent of the proposal, grant recipients and sub-grant recipients must now extend the RW eligibility and recertification requirements to this additional population. The amount of effort required to determine eligibility and recertify clients every six months cannot be ignored and oftentimes results in unnecessary delays in service provision, or worse yet, unnecessary elimination of services altogether (see comments related to Section C.3.).

Existing RSR reporting requirements state that when RWHAP funding covers only salaries, client level data must still be submitted in the RSR. Staff whose salary is paid by RWHAP must report all eligible clients who receive eligible services. This proposal would assume to now include staff whose salary is paid by RWHAP and RWHAP-related funding, increasing the reporting burden on those additional staff.

All RWHAP contract information is stored in the Grantee Contract Management System (GCMS). The GCMS uses information from previous RSR submissions, the Consolidated List of Contracts (CLC) and/or Program Terms Report (PTR) to populate each grant recipient's RSR Recipient Report with all the elements necessary to complete the RSR, such as subrecipient relationships and funded services. In the past, grant recipients were not required to synchronize any changes to the RSR Recipient Report as long as the subrecipient and service information populated from the GCMS were correct. With the proposed changes, under the existing structure, all RWHAP-related funded contracts will need to be included in the grantee's RSR Recipient Report. Since RWHAP-related contracts are not included in the grantee's CLC or PTR, all information related to these contracts will need to be manually entered and administered within GCMS by the grantee, thereby increasing the grantee's administrative and reporting burden.

Finally, when all sub-grant recipients have submitted their RSR Provider Report and client-level data, it is the grant recipient's responsibility to review the following for each sub-grant recipient: the Provider Report, the Upload Confirmation Report validation, the Completeness Report, and the Validation comments the sub-grant recipient has made. After reviewing and validating the data, the grant recipient must then "accept" each report individually. All new RWHAP-related contracts must now be included in this process, increasing the grant recipient's administrative and reporting burden.

AIDS Resource Center of Wisconsin (ARCW), Milwaukee, WI

According to Section C.2. of the RFI, HRSA is proposing to change requirements for the Ryan White Services Report (RSR) to include client-level data on patients and clients who receive services funded through Ryan White HIV/AIDS Program (RWHAP) grant funds as well as program income, starting in 2019.

ARCW applauds the intent of HRSA's RFI inasmuch as it strives to "seek input on changes to regulations or guidance that could reduce the burden and increase efficiencies for grant recipients and other stakeholders," as outlined in Executive Order 13771. Unfortunately, the proposed changes outlined in RFI Section C.2. would significantly increase the reporting burden for ARCW by increasing the amount of information that is now required and changing the parameters concerning which individuals must be included in reports without providing a new or more efficient reporting mechanism or tool. Moreover, it is unclear why HRSA needs the information and what HRSA intends to do with the information once collected.

In order to meet the guidelines stated in Section C.2., ARCW would now be required to report client-level data on a new subset of patients and clients who receive allowable services that were funded using program income, and not just funded with RWHAP grant funding. No ARCW RWHAP allowable service is fully funded using RWHAP grant funds. Furthermore, some ARCW patients and clients who receive RWHAP allowable services are not eligible to receive RWHAP funded services because they do not meet income eligibility guidelines. Often times, for the individuals ARCW serves, RWHAP eligibility changes throughout the year, but the critical programmatic needs for that individual remain unchanged. An increase or decrease in income or change in employment does not mean the individual is in any more or less need of health services.

The proposed requirements, much like current HRSA RSR requirements, fail to take into consideration the complexity of determining 'who' a Ryan White client is, 'when' they are a Ryan White client, and which 'part' of the RWHAP is funding client services at any given point.

For example, at ARCW, patients and clients can receive medical, dental, mental health, pharmacy, housing, food, legal and case management services all in one location, dependent upon their need and irrespective of their ability to pay or insurance status. During a typical patient visit to ARCW in Milwaukee, a patient visiting their doctor would be utilizing a service that is funded directly by Part C, funded using Part B resources via a subgrant and potentially further offset by program income generated through the 340B program. When on that same day that patient meets with their case manager, they are receiving a Part B funded service, and when they follow-up with the clinical pharmacist regarding medication adherence over the phone, they are receiving a service funded by 340B program income related to a Part B or Part C allowable service.

Determining which RWHAP-related services in the above scenario apply to any patient or client on any given day or during any visit is an incredible burden on service providers and staff responsible for generating RSR data. Given the RSR has more than 75 fields, and that information would need to be taken at each encounter for each of the approximately 5,000 patients and clients ARCW, an increase of only 5 minutes of documentation per provider per patient per year could result in more than 830 additional hours of reporting burden for ARCW per year. Currently, ARCW employs two full-time staff who devote a total of 600 hours per year addressing HRSA-mandated reporting, bringing the amount of time to over 1,400 hours per year (or approximately 175 days of reporting burden per year).

HRSA states in the RFI that not having the proposed new information somehow "limits HAB's and grant recipients' ability to measure the investment and impact of all RWHAP-related expenditures at the state and local levels." It is questionable as to how this newly requested information would enhance HRSA's ability to understand the investment and impact of RWHAP services. Specifically, the proposed reporting changes in Section C.2. are concerning because they would elucidate nothing related to the most significant impact of the Ryan White Program – helping people living with HIV achieve viral suppression and long-term health. It is simply more health care activity reporting, and does nothing to substantiate the significant return on investment the RWP has delivered in helping people with HIV live longer, healthier lives. At ARCW, 91% of patients are achieving viral suppression. This is the most critical indicator of our success and the impact of the RWP on the people we serve. Congress, the Administration and taxpayers would be much better served if HRSA were to endeavor to understand how the patients served by RWHAP services fare by measuring patient viral suppression rates and additional outcomes related to co-morbidities such as depression, addiction, diabetes, hypertension, hyperlipidemia and other prevalent health conditions as well as outcomes related to positively addressing factors that prevent patients and clients from engaging in and staying linked to health services such as food and housing insecurity, poverty, and lack of employment and educational opportunities.

AIDS United, Washington, DC (AIDS Resource Center Wisconsin)

According to Section C.2. of the RFI, HRSA is proposing to change requirements for the Ryan White Services Report (RSR) to include client-level data on patients and clients who receive services funded through Ryan White HIV/AIDS Program (RWHAP) grant funds as well as program income, starting in 2019.

ARCW applauds the intent of HRSA's RFI inasmuch as it strives to "seek input on changes to regulations or guidance that could reduce the burden and increase efficiencies for grant recipients and other stakeholders," as outlined in Executive Order 13771. Unfortunately, the proposed changes outlined in RFI Section C.2. would significantly increase the reporting burden for ARCW by increasing the amount of information that is now required and changing the parameters concerning which individuals must be included in reports without providing a new or more efficient reporting mechanism or tool. Moreover, it is unclear why HRSA needs the information and what HRSA intends to do with the information once collected.

In order to meet the guidelines stated in Section C.2., ARCW would now be required to report client-level data on a new subset of patients and clients who receive allowable services that were funded using program income, and not just funded with RWHAP grant funding. No ARCW RWHAP allowable service is fully funded using RWHAP grant funds. Furthermore, some ARCW patients and clients who receive RWHAP allowable services are not eligible to receive RWHAP funded services because they do not meet income eligibility guidelines. Often times, for the individuals ARCW serves, RWHAP eligibility changes throughout the year, but the critical programmatic needs for that individual remain unchanged. An increase or decrease in income or change in employment does not mean the individual is in any more or less need of health services.

The proposed requirements, much like current HRSA RSR requirements, fail to take into consideration the complexity of determining 'who' a Ryan White client is, 'when' they are a Ryan White client, and which 'part' of Ryan White is funding client services at any given point. For example, at ARCW, patients and clients can receive medical, dental, mental health, pharmacy, housing, food, legal and case management services all in one location, dependent upon their need and irrespective of their ability to pay or insurance status. During a typical patient visit to ARCW in Milwaukee, a patient visiting their doctor would be utilizing a service that is funded directly by Part C, funded using Part B resources via a subgrant and potentially further offset by program income generated through the 340B program. When that patient meets with their case manager, they are receiving a Part B funded service, and when they follow-up with the clinical pharmacist regarding medication adherence over the phone, they are receiving a service funded by 340B program income related to a Part B or Part C allowable service.

Determining which RWHAP-related services in the above scenario apply to any patient or client on any given day or during any visit is an incredible burden on service providers and staff responsible for generating RSR data. Given the RSR has more than 75 fields, and that information would need to be taken at each encounter for each of the approximately 5,000 patients and clients ARCW, an increase of only 5 minutes of documentation per provider per patient per year could result in more than 830 additional hours of reporting burden for ARCW per year. Currently, ARCW employs two full-time staff who devote a total of 600 hours per year addressing HRSA-mandated reporting, bringing the amount of time to over 1,400 hours per year (or approximately 175 days of reporting burden per year).

HRSA states in the RFI that not having the proposed new information somehow "limits HAB's and grant recipients' ability to measure the investment and impact of all RWHAP-related expenditures at the state and local levels.&quo;t Just as concerning to ARCW as the incredible increase in reporting burden is, the proposed reporting changes in Section C.2. are concerning because they would elucidate nothing related to the most significant impact of the Ryan White Program – helping people living with HIV achieve viral suppression and long-term health. It is simply more health care activity reporting, and does nothing to substantiate the significant return on investment the RWP has delivered in helping people with HIV live longer, healthier lives. At ARCW, 91% of patients are achieving viral suppression. This is the most critical indicator of our success and the impact of the RWP on the people we serve.

Boston Public Health Commission, Boston, MA

It is unclear what benefit this proposal offers with related to reducing reporting burden. This proposal sounds like additional reporting requirements from recipients and sub-recipients.

CAEAR Coalition, Washington, DC

Currently, some agencies are reporting every HIV positive client served, regardless of payer, while some are only reporting those who received directly a specific Ryan White-funded service. Changing the reporting scope would only further confuse people on who needs to be reported. It will also continue to "muddy the waters" for the data that are submitted and reported as being representative of the work of the Ryan White Program. Before expanding the reporting scope, it would be helpful if HRSA/HAB investigated the types of services reported and whether they are RW funded or not by program, Ryan White part, and jurisdiction.

California Department of Public Health, Sacramento, CA

  • In 2015, HAB moved from "funded scope" to "eligible scope" reporting for the RSR. Many RSR-ready vendors had to reprogram their systems to meet this need. Additionally, providers did not (and do not) receive additional funding to collect, enter, and manage non-Ryan White funded data into their systems. Many RWHAP-funded providers only enter Ryan White data into CAREWare, ARIES, Casewatch Millennium, or other systems.
  • In order to assess the value of including RWHAP-related funding (e.g., direct RWHAP funding, sub-grant recipient funding, program income, and RWHAP ADAP rebates) on the RSR, it would be critical for HAB to analyze the impact and value of moving to eligible scope reporting. For example, did the transition to eligible scope reporting meet HAB's expectations? Did providers implement it fully and correctly? How has the change impacted the RSR data that is reported to HAB? Such an evaluation may help shape how to efficiently and effectively implement this change.
  • If HAB decides to include RWHAP-related funding, HAB needs to provide concrete guidance on program income. There is a great deal of confusion about how to identify, track, use, and report program income. This inconsistent approach to program income will impact the completeness of the RSR.
  • If HAB decides to include ADAP rebates, this information should be reported on the ADAP Data Report (ADR), not the RSR.

California Primary Care Association (CPCA), Sacramento, CA

Although reporting data by different funding sources, whether directly funded or not, may allow for a more complete picture of service utilization patterns and trends for HRSA, there are many challenges with gathering and reporting related but not directly funded services. In many cases, multiple databases are used to collect client data for programs funded at the county, state, and federal (i.e. CaseWatch, LEO, ARIES). There are restrictions and limitations with data sharing across systems, issues with internal protocol policies and procedures for collecting data, interfacing, and requesting customized reports. Before considering the collection of related services data, major strides need to be made to create a streamlined, centralized, effective, and less burdensome data collection system that could be used at all funding levels.

CAN Community Health, Inc., Sarasota, FL

This RFI is intended to "seek input on changes to regulations or guidance that could reduce burden and increase efficiencies for grant recipients and other stakeholders." In Section C.2 of the RFI, however, HRSA proposes to change the requirements for the Ryan White Services Report (RSR) client-level data to include data on patients whose services are funded through rebate dollars or Ryan White HIV/AIDS Program (RWHAP) program income starting with the 2019 RSR. This would seem to run counter to the reduction of burden and increased efficiency in the outset of the RFI. Moreover, it also seems to contradict Executive Order 13771, titled "Reducing Regulation and Controlling Regulatory Costs," which works to identify "regulations and other policy guidance or procedures that are outdated, unnecessary, or ineffective, impose costs that exceed benefits; or are otherwise inconsistent with established regulatory policy and guidance." Changes to client-level reporting to increase the detailed information on how rebates and program income are expended will neither reduce burden nor increase efficiency. Program income reports submitted via the Federal Financial Report already provide sufficient accountability for compliance with OMB guidelines. Additional reporting, or alternative reporting at a less aggregate level, will create an administrative burden with little or no additional gain for client services.

Central Carolina Health Network (CCHN), Greensboro, NC

While CCHN understands HAB's desire to better understand the service utilization and outcomes for services funded by RWHAP-related sources, we consider this an overreach of HAB's scope. One of the main benefit s of no n-RW HAP funding sources is the flexibility that they allow for programs to implement creative program structures and solutions that are not subject to heavy administrative burden. As an agency that currently submits Ryan White Service Report data for both Part B and D programs, the misaligned timeframes of the two programs and number of subcontractors in our network already make the RSR a time-consuming and challenging process for a small organization like ours. An additional reporting requirement linked to funds that are not directly tied to HRSA grants will create more work that diverts us from our main goal of serving people living with HIV. We strongly suggest that HAB reconsider this change in reporting and seek to gather information on these RWHAP-related income sources in a less burdensome manner, if at all.

C​ommonwealth of Kentucky HIV/AIDS Branch, Frankfort, KY

Under RFI C.2 Rebate/Program income reporting. I think it would be beneficial for us to report every expenditure instead of trying to keep the expenditures separate because we don't always know

When rebates/program income will arrive at the program and we have to spend rebates/program income before we spend grant dollars and this is very hard to keep track of when you think you may be doing

Okay and then you receive a flux of rebates and we must try and spend before the grant ends.

Community Clinic Association of Los Angeles County (CCALAC), Los Angeles, CA

Although reporting data by different funding sources, whether directly funded or not, may allow for a more complete picture of service utilization patterns and trends, there are potentially many challenges with gathering and reporting related but not directly funded services. We are concerned that this proposal raises issues related to restrictions and limitations on data sharing across systems, internal protocol, policies and procedures, interfacing and other IT challenges. This proposal seems premature given the limitations and challenges of existing data collection systems.

Department of State Health Services, Texas Part B, Austin, TX

  • Eligible scope reporting is very difficult, as it requires income verification, when in reality, any patient could be eligible for services regardless of the income at entry into care. Meeting this requirement would be easier if it required general input of all patients receiving HIV care services. Requirement of income verification and eligibility screening for patients with a payor is a barrier to care and is an undue burden on the patient and provider. As providers diversify their payor mixes to support the sustainability of programs, it is important that we don’t burden those patients with payors, as it negatively impacts the organizations.
  • The need for providers to report on all patients is overall very burdensome. Especially, when the largest payors for services are Medicaid and Medicare – it would be more reasonable to think that a data sharing agreement with CMS could ensure those data are reported to HRSA for reporting. This would increase the administrative burden on provider as they will have to enter data into the system they are not currently entering without additional staff or financial support.
  • If the purpose of the RFI is to investigate ways to "reduce public and stakeholder burden in complying with administrative and reporting requirements," this proposal will have exactly the opposite effect. If non-RWHAP-funded services are subject to the same data reporting requirements as RWHAP-funded services, then the level of administrative and reporting requirements would increase rather than decrease. As the purpose of the RSR is to monitor and track Ryan White fund usage (and by extension, state-provided matched funding with requirements that mirror RWHAP fund usage), then it seems that there is no governmental authority to provide oversight on privately raised and/or non-governmental funds.

EVMS Medical Group, Norfolk, VA

HRSA proposes to change client-level reporting to include eligible clients who receive RWHAP allowable services that were funded using RWHAP and RWHAP-related funding (e.g., direct RWHAP funding, sub-grant recipient funding, program income, and RWHAP ADAP rebates) starting with the 2019 RSR. I think this would be more accurate of all the clients we serve but what updates will be required of those clients to include them so that identical information is captured on all clients. And if the updates are twice a year, now we are referring to over 3000+ clients and it is again very burdensome on clients and staff to obtain pretty much identical eligibility information that was obtained at the first update.

Family Health Centers of San Diego, San Diego, CA

No, the Ryan White program should collect client level data regarding any patient who receives any Ryan White funded services, regardless of which part. It is our belief that efforts would be better spent to coordinate data reporting with CDC because the combined data could paint a very useful picture in advocating for the effect of program dollars on clients.

Grady Health System Infectious Disease Program, Atlanta, GA

Currently, some agencies are reporting every HIV positive client served, regardless of payer, while some are only reporting those who received directly a specific Ryan White-funded service. Changing the reporting scope would only further confuse people on who needs to be reported. It will also continue to “muddy the waters” for the data that are submitted and reported as being representative of the work of the Ryan White Program. Before expanding the reporting scope, it would be helpful if HRSA/HAB investigated the types of services reported and whether they are RW funded or not by program, Ryan White part, and jurisdiction. It would also be useful to wait until the new CAREWare web-based system is fully launched and operational for at least a year to give agencies using CAREWare time to adjust their processes to the new system before introducing any other changes.

Hawaii Department of Health, Honolulu, HI

Regarding RFI Section C.2., this jurisdiction has conferred with the operator of its electronic data collection system. The operator of the electronic data collection system had been previously made aware of this proposed change and had analyzed the possible impact on operations. The electronic data collection system operator has determined that the impact of this change on the data collection system and on operations will be minor.

HIV Medicine Association (HIVMA), Arlington, VA

Regarding HRSA's proposal to change client-level reporting to include eligible clients who receive Ryan White Program allowable services funded both with Ryan White and Ryan White-related funding, HIVMA and RMWPC support the idea of this new data collection. However, if implemented, it would be important that HRSA/HAB collect these data in the aggregate - in terms of how a Ryan White clinic serves its patients overall. HRSA/HAB should not require clinics to track these data by specific patient encounter or specific payor source. If HRSA/HAB were to require this level of specificity, it would create data collection and tracking problems that would be very difficult for Ryan White clinics to overcome and would likely generate unreliable data that could not be compared across clinics. For example, a hospital-based Ryan White medical provider stated that for clinics that don't track 340B program income because the 340B program is run by their parent institutions (such as hospitals) it would be extremely difficult to impossible to report on that payor source for those services. Additionally, some Ryan White medical providers are concerned about the challenge of reporting on services provided with Ryan White income via CareWare. At clinics embedded in larger institutions, such as hospitals, the task of using CareWare to track Ryan White-related income could be difficult to achieve. Therefore, if HRSA/HAB decides to introduce the new data collection requirement, HIVMA and RWMPC urge that in addition to requesting data in the aggregate that HRSA/HAB provide technical assistance and training appropriate to all types of Ryan White Program grantees, and that the training include clear examples for how grantees can best meet the new data collection requirement.

Holmwood Data Consulting, Ridgewood, NJ

As a TGA we want our data to reflect as much as possible all of the PLWH served within our Ryan White system of care so we approve of data reporting that shows the full picture. However, CAREware upgrades need to be done in a timely way to correspond with any changes in reporting requirements so that we have a mechanism to track any additional data and report it accurately.

Massachusetts Department of Public Health, Boston, MA

Ryan White Services Report Data Submission Changes — The changes proposed in this section regarding reporting services funded with non-HRSA dollars would be quite burdensome due to the complexities of tracking other income. This proposal does not seem in keeping with the stated purpose of streamlining & burden reduction as it would involve more reporting by grantees and subrecepients. In addition, it is unclear what the purpose of this reporting is, as well as the legislative basis that HRSA has for requiring it and the ultimate goal of the proposal.

Mendocino Community Health Clinic (MCHC), Ukiah, CA

Although reporting data by different funding sources, whether directly funded or not, may allow for a more complete picture of service utilization patterns and trends for HRSA, there are many challenges with process. In many cases, multiple databases are used to collect client data for programs funded at the county, state, and federal (i.e. CaseWatch, LEO, ARIES). There are restrictions and limitations with data sharing across systems, issues with internal protocol policies and procedures for collecting data, interfacing, and requesting customized reports. Before considering the collection of related services, major strides need to be made to create a streamlined, centralized, effective, and less burdensome data collection system that could be used at all funding levels.

NASTAD, Washington, DC

Health departments are increasingly implementing comprehensive and integrated activities and services across HIV, viral hepatitis, STD, and TB programs. Health departments leverage multiple funding streams to support well-coordinated, integrated services. It is often not possible to precisely determine which funding stream(s) pay for a particular service or component of a service. In fact, doing so distorts the contribution of individual funding streams. NASTAD understands the desire to have data on all clients and services touched by a RWHAP funding stream, whether directly from the federal grant or another source. However, as RWHAP have grown and interact with an evergrowing list of other payers, this could greatly increase the amount of data being handled and collected by Ryan White Part A and B recipients. Changing the data collection system for receipeints and sub-receipients would be quite burdensome due to the complexities of tracking other programing income. This proposal is not keeping with the stated purpose of streamlining and burden reduction, as it would involve more reporting by grantees and subrecipients.

NASTAD believes that in order to fully move forward with such a proposal HAB must more fully explore the costs and capacities of current systems to move in this way. The current RSR scheme and internal state data systems are not all poised to track services by many different funding streams. Additional consultation with receipients is necessary.

New York City Department of Health and Mental Hygiene, Queens, NY

The Health Department has concerns that HRSA's proposal to change client-level reporting to include eligible clients receiving Ryan White allowable services funded using Ryan White and Ryan White-related funding could cause confusion. Based on informal reports from Health Department Ryan White providers, some agencies currently report every HIV-positive client, while others report only those directly receiving a specific service. Changing the reporting scope could further confuse agencies regarding their reporting obligations, and further compromise the integrity of the data. The Health Department recommends that HRSA assess the data currently collected before altering reporting scope.

Powers Pyles Sutter & Verville PC, Washington, DC

In Section C.2 of the RFI, HRSA proposes to change the requirements for the Ryan White Services Report (RSR) client-level data to include data on patients whose services are funded through rebate dollars or Ryan White HIV/AIDS Program (RWHAP) program income starting with the 2019 RSR.

As an initial matter, we note that HRSA's RFI is intended to "seek input on changes to regulations or guidance that could reduce burden and increase efficiencies for grant recipients and other stakeholders." The impetus for this effort is the Administration's vision for regulatory reform as outlined in Executive Order 13771, titled "Reducing Regulation and Controlling Regulatory Costs," which requires federal agencies to take specific actions to reduce regulatory burden. We are pleased that HRSA is striving for the "identification of regulations and other policy guidance or procedures that are outdated, unnecessary, or ineffective, impose costs that exceed benefits; or are otherwise inconsistent with established regulatory policy and guidance." We strongly support those goals. For that reason, we do not support the proposal in Section C.2. Instead of reducing regulatory burden, it would actually increase that burden by requiring Ryan White grant recipients and sub-recipients to collect and submit additional data in the RSR. A proposal to require additional reporting by Ryan White recipients and sub-recipients should not be part of an RFI that is intended to reduce administrative reporting requirements.

Even more troubling is that HRSA is proposing to implement the new reporting requirements starting with the 2019 RSR. Ryan White Clinics Coalition members operate across the United States and bring critical health services to underserved individuals living with AIDS/HIV. Many operate in rural areas where there are no other providers. Many are small clinics with limited budgets. These clinics are constantly working to stretch scarce resources to serve their vulnerable populations.

The proposal in Section C.2. would require clinics to collect client-level data on a whole new population of patients. The RSR client-level form has over 75 fields and information would need to be collected for each encounter. This will take at least 10-20 minutes per encounter, which could mean several hours a day of additional staff time that would have to be diverted from our clinics' core mission of meeting the health needs of HIV/AIDS patients. Moreover, although a few larger clinics have electronic medical record systems that can transmit information electronically to CAREWARE, most facilities do not have this ability and would need to manually input the additional data.

Nor has HRSA articulated a reason why this information is needed. It only states that not having this additional data on this population "limits HAB's and grant recipients' ability to measure the investment and impact of all RWHAP-related expenditures at State and local levels." According to the 2017 Progress Report on the National HIV/AIDS Strategy for the United States (p.22), the overall percentage of RWHAP patients receiving medical care who achieved viral suppression increased from 69.5% in 2010 to 84.9% in 2016. These statistics, which are based on the information collected from clients whose care is fully-funded by RWHAP, testify to the success of the RWHAP. We believe the proposal to collect additional data from additional patients would add little to our understanding of the impact of the RWHAP and any benefit is outweighed by the administrative burden it would impose.

In addition, we point out that this proposal is subject to the Paperwork Reduction Act (PRA), 44 U.S.C. § 3501, et seq. A primary objective of the PRA is to "minimize the paperwork burden for individuals, small businesses, education and nonprofit institutions . . ." 44 U.S.C. § 3501. This requires that HRSA, before it can adopt or revise a collection of information, first publish a notice in the Federal Register with a 60-day notice period to solicit comment from members of the public. 44 U.S.C. § 3506(c)(2)(A). The notice must include a description of the need for the information and an estimate of the total annual reporting and recordkeeping burden that will result. 5 C.F.R. § 1320.5. Finally, the proposed collection must be submitted to the Office of Management and the Budget (OMB) for approval triggering another 30-day public comment period and an additional 60-day period for OMB to notify the agency of its decision. 44 U.S.C. § 3507.

Apart from the many reasons why this proposal should not be implemented, we point out that it would be virtually impossible for HRSA to complete the requirements of the PRA in time to submit data for the 2019 RSR. Although the RSR is not due until the end of the year, it requires clinics to engage in ongoing encounter-level data collection beginning January of 2019. Therefore, implementation would have to start January 1, 2019. We do not believe this implementation date is possible given HRSA's obligations under the PRA.

For all of the above reasons, we urge HRSA to abandon this additional data collection initiative, which is in direct contradiction to the Administration's goals of reducing regulatory burden, the stated purpose of the RFI and has not been reviewed under the PRA.

Prism Health North Texas, Dallas, TX

Requiring grant recipients and sub-grant recipients to submit client-level data for eligible clients who receive services using Ryan White HIV/AIDS Program (RWHAP)-related funding adds additional administrative burdens and requirements to a system that has become heavily regulated. We are therefore opposed to imposing additional administrative requirements on the program.

The National Center for Innovation in HIV Care released a report entitled Enhancing the Sustainability of Ryan White-Funded AIDS Service Organizations and Community-Based Organizations. The report shared that when analyzing RWHAP funding, which included adjustments for inflation, the appropriations had remained level since 2003. Despite level funding there has been increasing numbers of individuals served through the Ryan White program. As conveyed in this report, the Ryan White Part C program alone sustained a two-thirds increase in one decade.

During this same time HRSA has continued to issue more policy requirements relative to documentation, for instance requiring eligibility recertification twice per year. Documentation needs related to programmatic, quality management and fiscal program compliance require the implementation of complex data systems capable of reporting on myriad mandates including comprehensive assessments; documentation of eligibility requirements; detailed programmatic records such as care plans and acuity assessments; compliance with and evidence of operationalizing standards of care and performance measures; and adherence with a plethora of mandated policies and procedures from federal, state and local administrative oversite for the Ryan White Program. Anecdotally, case management staff at this agency reports that 40% - 50% of their time is now spent on documentation related to regulatory obligations as the agency continues to sustain increases in clients accessing care. On average the agency assists more than 600 new clients per year, despite no measurable increase in funds to support corresponding service needs and the related increases in administrative reporting requirements. We are therefore opposed to adding yet more administrative reporting requirements, thereby impacting already strained staffing needed to provide care and treatment to clients.

SFDPH - HIV Health Services, San Francisco, CA

San Francisco is concerned with the introduction of new or expanded reporting requirements connected with existing Ryan White funding streams. Many jurisdictions, such as a Part A metropolitan area, do not administer rebate funding connected to state ADAP programs, and any additional reporting requirements for services funded by rebates would add, not reduce, reporting burden. Changing client-level reporting to include clients who receive RWHAP allowable services funded using RWHAP and RWHAP-related funding (e.g., direct RWHAP funding, sub-grant recipient funding, program income, and RWHAP ADAP rebates) would to add confusion as to the RSR's reflection of the work of the Ryan White Program.

State of Wisconsin Department of Health Services AIDS/HIV Program, Madison, WI

The Ryan White Services Report (RSR) is already an extremely burdensome process for Part B agencies in Wisconsin; due to technology issues, some Ryan White Part B-funded agencies in Wisconsin are forced to go through paper charts for each client and manually report what services the client received.

While we appreciate that the intention of the proposal is to better monitor services people living with HIV receive, the impact of the proposal would be to force organizations providing services, which are already burdened by reporting requirements, to spend more time on reporting and data analysis. This proposal would be especially burdensome for smaller agencies that receive funding from multiple public and private sources, many of which impose their own reporting requirements and funding restrictions. Requiring agencies receiving ADAP rebates to spend more time on reporting requirements might lead to employee frustration and burnout, or a reduction in the amount of time agency staff are able to spend serving people living with HIV (PLWH).

The Wisconsin Department of Health Services strongly urges HRSA to maintain the current RSR requirements rather than expanding them.

University of Mississippi Medical Center, Jackson, MS

This will take significant time and should require additional financial allocation for support staff to perform more data entry.

University of Wisconsin School of Medicine and Public Health, Madison, WI

We feel that our program has the ability to report on RWHAP-related program income funded services in the RSR. We feel that reporting on these services would provide a more comprehensive view of the reach of our program and the RWHAP as a whole. However, if this change were to be implemented we feel that additional guidance is needed on identifying RWHAP program income and the timing of the data reporting change needs to be planned carefully.

Additional clarity is needed on how to calculate program income because we have heard various definitions of how to calculate Ryan White 340B program income and program income from third party payers. Some have said that all third party payment revenue earned by an HIV clinic that receives Ryan White funding is program income while others have said it is directly linked to what the grant funds (i.e., a provider sees 10% Ryan White clients so 10% of their payer revenue is program income). And yet another argument would be to look at the revenue generated from Ryan White eligible patients’ visits. RWHAP clinics have complex funding models, with multiple revenue streams, and determining what is RWHAP program income isn’t straightforward. Regarding 340B program income, HRSA has said that the difference between the reimbursement from a third-party payer and the cost of the drug is the program income. However, programs with a 340B Drug Pricing Program have certain contracting and compliance costs that are necessary to participate in the program (contract pharmacy dispensing fees, administration costs, and external audits) and we feel these costs should be deducted in the calculation of program income.

The timing of this new reporting requirement is important because data workflows and reporting tools, such as CAREWare and the new Epic Ryan White module, will need to be modified in order to implement this change. Therefore any change to reporting program income funded services on the RSR should be implemented at the beginning of an RSR reporting year, January 1, and grantees should be given a 6 month notice prior to the change in order to update systems and workflows.

UPMC Pinnacle, Harrisburg, PA

RWHAP should be held accountable for outcomes utilizing program income and therefore could and should report on clients served using RWHAP-related funding.

Waterloo Counseling Center, Austin, TX

This seems to be meaning that clients who are HIV+ and are insured or who are not relying on RW for payment for services (100% private pay) would be entered into ARIES? I hope this is not the case. HRSA is not inherently entitled to this information and it would be a violation of HIPAA for us to enter this information without written consent and release from the client.

Enacting this will have an adverse effect on clients who are not seeking services under RW. They may choose to walk away from services in favor of a private practitioner, who will not report their PHI but who lacks the expertise they were seeking from a mental health provider who understands HIV. This may also cause such a client not to disclose their HIV status to their therapist, which is a problem. Word gets around, and this will have a negative impact on our ability to serve HIV+ insured people.

If such a client refuses to sign a written consent to enter this information, does this mean we may not see the client and must refuse him services? Even though RW is not paying for the service?

I also need to understand exactly what information is expected to be entered. If it is related to eligibility, do we have to perform six month and annual updates on RW eligibility and re-enter that information as well? Do we need to demand proof of HIV positivity to serve someone who discloses that they are positive, but who is not using RW as their payor?

How will HRSA know this policy is being followed? What will AAs have to do at site visits to determine that the provider is entering the information of all HIV+ clients, regardless of their insurance status? Will that require examining all client files, including those clients who report as HIV-? What if someone's HIV status changes? They are then subject to this policy, which will feel invasive. This policy is unenforceable, unmonitorable, and rife with the dangers of HIPAA violations. It will add a barrier to service for clients not served under RW and complicate service delivery for providers. I strongly ask you to consider not moving forward with this policy.

If the intent is truly to reduce burden and streamline processes, this policy should not move forward.

Whitman-Walker Health (WWH), Washington, DC

General Comments: HAB should take this opportunity to more clearly define the discrepancies between Ryan White-funded services and Ryan White eligible clients. Whitman-Walker serves many more HIV-positive patients who are eligible for Ryan White services, than are paid for by the amount of funding we receive. We suggest that HAB ask grantees to provide data on their total patients diagnosed with HIV; total patients diagnosed with HIV who would qualify for Ryan White services given income and other requirements; and the number of such individuals actually covered by funds provided.

That HAB is receiving less data via the RSR, is as a direct result of unclear and sometimes contradictory guidance from HAB regarding which persons are eligible for services. HAB should not change client-level reporting requirements to be inclusive of all Ryan White eligible clients funded directly by Ryan White monies, by sub-grantee funds, by program income and by ADAP rebates, without first clearly issuing guidance that clarifies the related issue of eligibility.

With higher levels of health insurance available for our patients, many living with HIV do not always directly benefit from Ryan White services, as their insurance pays for those services. While Ryan White provides some support for insurance navigation and medical adherence nurse staff, there may not be a direct patient service level benefit being provided. This means that patients do not understand why they must provide the personal information required for Ryan White reporting when they do not see what service it is paying for.

Health care providers like WWH, located in jurisdictions such as the District of Columbia which have expanded health insurance eligibility (through Medicaid expansion and higher income/asset thresholds), are penalized in that they cannot claim Ryan White clients for medical or behavioral health services — even though those clients receive many services that are uncompensated which we are still providing. Ryan White guidance is unclear around allowing the "treatment completion concept" where insurance covers some aspect of an eligible patient’s care and Ryan White wraps around what was covered by insurance to cover the rest of the care. Without the ability to apply the "treatment completion concept," these services that are not fully paid for or that health centers provide as wrap around go unfunded. HAB should take every opportunity, not prevented by clear legislative language, to enable and encourage Ryan White programs to provide wrap around services and fund care completion. National data indicates that persons who access Ryan White services enjoy better health overall than those who do not. These wrap around services and care completion promote better health outcomes.

WV Bureau for Public Health, Charleston, WV

WV currently expends rebate funding prior to utilizing grant funds. We understand the importance of reflecting accurate information regarding recipient services and agree to submit necessary data.

RFI section C.3

Comments from General Public

Comment #1

When clients become ineligible because their phone bill is not paid or we temporarily lose contact with a client — they are at risk for not getting their meds or medical services — this works against us in trying tom reach viral load suppression. Eligibility should be moved to once annually — plain and simple.

Comment #2

Thank you for the opportunity to provide feedback.

HERE IS MY PERSONAL STATEMENT REGARDING RYAN WHITE FUNDING: THE FUNDING WAS CREATED TO PROVIDE CARE TO HIV/AIDS PATIENTS. THE GOAL IS FOR PATIENTS TO ACHIEVE VIRAL SUPPRESSION AND REMAIN IN CARE. AS YOU KNOW WITH THE MANY YEARS OF FUNDING AND THE AMOUNT OF FUNDING THAT THE GOVERNMENT APPROVES FOR THIS GRANT WE ARE FAILING — AS EVIDENCED BY THE NATIONAL SUPPRESSION RATE! WHY ARE WE FAILING? BELOW ARE SOME REASONS THAT WE ARE:

Please see recommendations/STRONG suggestions below:

Request to REQUIRE the State and local Administrative Agencies to align the Universal Standards and local Standards of Care. It is very DIFFICULT and EXTREMELY CHALLENGING to provide guidance to staff and also provide direction to patients when we have to follow two of them: WHAT DO YOU WANT US TO DO? Especially when an agency is funded by different parts of the grant.

Allow Ryan White Eligibility to be required only once a year. Patients are tired of having to update all their information EVERY six months — to include ADAP. Patients get frustrated and lose hope when they can't obtain the required documents that will allow them to remain in care and achieve viral suppression (again missing the whole point of why the grant exists). I have heard patients state that they would rather not be in care and much less take their medications!

Require auditors to be companies that are independent that are willing to learn the requirements of Ryan White so it can be an OBJECTIVE result. Also, it needs to be uniformed — we have Part A auditors that will say one thing and then you have Part B auditors that same something different — AGAIN WHAT DO WE DO? WHAT DO YOU WANT US TO DO?

Auditors should also be required to ask the staff that are actually doing the work how their specific program works. Instead of coming in to audit and making decisions on an audit based on "what they think". Not allowing staff that are doing the work the opportunity to provide feedback, creates frustration and is demoralizing when results of audits are given, which may not be accurate because it is based on the auditor's thoughts or perceptions.

HRSA/HAB/DSHS/AA's should sit down or request feedback directly from "the boots on the ground (providers, case managers, nurses, front desk staff, etc..)" on what is needed or what policies/processes/procedures will work or just plainly what are they hearing from patients — why aren't they in care? Why aren't you taking your medicine? What do you think about the Ryan White Eligibility process? What do you think about the ADAP process?

Policies should NOT be created by people that have never worked directly with a patient or a "DYING PATIENT" in their office — because you don't know what it is like when a patient needs assistance because they may not be "ELIGIBLE" for assistance. ELIGIBLE IS A BROAD TERM HERE — EXAMPLE: IF THIS PATIENT COMES IN FOR SERVICES (BECAUSE THEY ARE SICK) IF THEY COULD NOT PROVIDE PROOF OF RESIDENCE (WHICH BY THE WAY MAY BE DIFFERENT FOR PART A AND PART B) THEN WE DON'T SEE THEM UNDER RYAN WHITE? IF WE DO SEE THEM AND WE GET AUDITED THEN WE GET DINGED FOR NOT HAVING PROOF OF RESIDENCE (BUT IRONICALLY MAYBE HE HAD PROOF OF RESIDENCE 6 MONTHS AGO). THIS IS JUST ONE EXAMPLE OF SOOO MANY. Another example is Non-Medical Case Management vs. Medical Case Management — we will sometimes need a Medical Case Manager to assist a patient in obtaining their HIV medication (re-certify for ADAP) but low acuity, we get dinged by the auditor for this because we billed a Medical Case Management visit when that patient should have seen the Non-Medical Case Manager that possibly wasn't available that day (full ledger) or out sick. I am not going to allow a patient to not be seen that needs to obtain medication because we are "afraid" to get dinged by the auditor.

THIS IS VERY FRUSTRATING AND CHALLENGING BUT MOST OF ALL IT IS NOT SOMETHING THAT HIV PATIENTS SHOULD BE CHALLENGED WITH, AS WELL.

INSTEAD OF CREATING NEW PROGRAMS AND NEW FUNDING BECAUSE WE ARE FAILING (BASED ON DATA), LET'S TRY TO FIGURE WHY WE ARE FAILING, JUST THINK ABOUT HOW MUCH FURTHER WE WOULD BE IN ACHIEVING OUR GOALS OF PROVIDING EXCELLENT QUALITY CARE TO HIV PATIENTS, RETAINING PATIENTS IN CARE, AND ACHIEVING VIRAL SUPPRESSION IF WE JUST TAKE A STEP BACK AND RE-EVALUATE AND LISTEN TO FEEDBACK FROM THE STAFF DOING THIS WORK!

Again, I appreciate the opportunity to provide feedback and will continue with our mission to provide excellent quality care to all of our patients!

Comment #3

I think six month recerts are extremely difficult in the field for worker, vulnerable population and people impacted by social determinates. Some patients have complained about additional meetings with enrolling staff, financial counselors and case manager thus impacting their willingness to engage with us.

Comment #4

Eligibility Criteria Comments supporting the modification of the six-month recertification policy
HIV Status
  1. Does not change
Income
  1. Usually it is the same or less.
  2. "HIV Health care and support services provided by the CARE Act must be offered without regard the individual's ability to pay"
    (Source: FY 2002 Grant Application Guidance, August 2001)
  3. The certification form of the Medicaid Program officially validates this criteria on an annual basis.
Residency
  1. May need some time to make the transition to other funding source.
  2. Moreover, "a non-citizen can receive services under these programs"
    (Source: May 26, 1999, Claude Earl Fox, MD, MPH, HRSA Administrator communication)
  3. The certification form of the Medicaid Program officially validates this criteria on an annual basis.
Insurance Status
  1. Does not represent a barrier to receive services.
  2. The critical issue is "to have a system in place to bill and collect from the appropriate third party payers"
    (Source: Tools for All Grantees: For all Grantees-Third Party Reimbursement FAQs, 2003)
  3. The certification form of the Medicaid Program officially validates this criteria on an annual basis.

Comment #5

Prior to the Affordable Care Act there was a need to re-examine whether or not there were any changes in a client's eligibility status with particular emphasis on income and insurance coverage. During a one year period, very few clients experience income or healthcare coverage changes significant enough to disqualify them for RWHAP services. The six month recertification requirement is a burdensome process that in certain instances creates a barrier to care as well as inhibition to maintain client's in care.

In the ACA environment, this requirement should be eliminated in an effort to allow line workers to be able to provide services to clients versus the effort required now in chasing paperwork.

Comment #6

[...]** I find the 6 month recertification an exercise in futility. It is indeed burdensome for both the intake specialist as well as the consumer. It is not expressed in the HAB guidelines that Ryan White eligibility recertification documents must coincide with lab reports in order to receive services, but this caveat causes a lot of challenges when you are in need of service. Essentially as a client, you do the recertification only to find out that your labs just expired so you have to come back to get the lab work so you can get a referral for services. I believe the preliminary findings that consumers don't actually have any changes during this six month period is correct. [...]** Perhaps a revision in which the recertification can be done yearly with understanding that if any changes occur the consumer must recertify. I believe this would be best practices for grant recipients and remove a barrier to care for people living with HIV.

** denotes parts of the comments have been redacted

Comment #7

Thank you for the opportunity to comment. I would suggest, if the data reports identify problems regarding engaging people in care, with emphasis on engaging through certification/recertification processes, that it would stand to reason it may be because the policy itself is stigmatizing when viewed from a trauma informed care lens. The folk who comprise the HIV community have higher prevalence to belong individually to a collectivity of minorities. These individuals are subjected to a lifetime of mistreatment or maltreatment across multiple systems that drive society, based on the issues endured by each minority represented singularly and collectively. The statistic is plentiful that support the notion of "cultural trauma" whereas persons of color, sexual orientation, gender identification, sexual practices and or other affects deemed to be so categorized, experience disproportionate rates of traumas over the course of a lifetime. Further damaging are the adverse childhood experiences that are more prevalent in lower socioeconomic individuals, families, communities, etc. During the formative years exposure to traumatic life experiences causes impairment of an individual's brains to process from a relaxed and calm state of mind. Once activated, the fight flight or freeze reactions are replayed repeatedly in that persons maturing process. Trauma informed care can provide a meaningful solution to engagement in care across all domains of that adherence represents (medical adherence, medication adherence, certification adherence, which could mean multiple certifications for a variety of necessary services, etc.). Once we are mindful to the whole of people we serve and truly want to ensure a large return on investment of funding the best chance we have is by ensuring all agencies receiving HRSA dollars, from top to the bottom and back up again are certified in delivering Trauma informed care to all PLHIV. This ideological shift will help inform policymakers as they take the next step that shows efficacy regarding treating people with histories of trauma. HIV diagnosis itself, is a trauma. Please consider making this a policy choice; education and training on trauma informed care as a service delivery model which require certifications for all entities and their staffs whose HAB funding stream touches (make haste while funding remains and before 340b becomes the cash cow for political purposes rather than the affected communities the funding is meant to serve). Developing trauma informed care policy directives will improve quality measures across the board. Diminishing the punitive perception of what having to expose your most personal details regarding sexual practices, numbers of partners, income sources, expenditures, judgment, judgment, judgment. PLHIV experience enough shame and self-judgment and the current policy that requires biannual recertification is yet one more reminder for a PLHIV of the reality of living with HIV. It would also seem plausible based on the information you have been collecting over the years, that for most persons receiving RYAN WHITE services experience little change in their income in several years, let alone six months, has that been studied? Furthermore, it would also seem that much of that information could be verified through the IRS and Dept of Homeland Security, which seem to have tethers to all things. The data you seek has already been compiled and presented on, numerous studies on the growing field of trauma informed care as a human services delivery care model and the benefits attributed to it.

[...]** as a clinical social worker in an HIV hospital‐based part B, C recipient, I humbly request consideration of my suggestions. Provide funding for TIC training / certification for all HRSA HAB policy makers and staff and to all persons in all positions all along the delivery model. Review the current information required/requested during certification and find ways to make it less intrusive and minimize or avoid re‐traumatizing and limit such recerts to once a year or every several years. PLHIV deserve to feel safe, provide safety is key to engagement with persons with history of trauma.

The World Health Organization declares; "Poverty is the single determinant of health outcomes"

** denotes parts of the comments have been redacted

AIDS Institute - New York State Department of Health, Bronx, NY

According to a 2017 HRSA press release, "HRSA awards $2.36 billion in grants to help Americans access HIV/AIDS care and medications. Grant awards in FY 2017 support states, cities, counties, and communities to achieve the national goals to end the HIV epidemic. These include efforts to reduce new HIV infections, increase access to HIV care and improve health outcomes for people living with HIV infection, and reduce HIV-related disparities and health inequities."

In 2014, the Governor of New York outlined New York State's Ending the Epidemic (ETE) initiative — the plan to end the AIDS epidemic in NYS. As part of the three-point plan, increased efforts are being directed toward: 1) identifying persons with HIV who remain undiagnosed and linking them to care; 2) linking and retaining persons diagnosed with HIV in health care to maximize viral suppression; and 3) facilitating access to Pre-Exposure Prophylaxis (PrEP) for high-risk HIV-negative persons.

NYS Medicaid and other Public Assistance programs recertify on an annual basis. Other health care coverage programs such as the Medicare Savings Programs and EPIC certify eligibility annually or less often. It is unreasonable to impose more stringent certification requirements on people living with HIV and AIDS.

ADAP participants face substantial hurdles certifying their eligibility every six months. Frequent requests for information cause confusion and frustration. Despite efforts to create documents that are easy to understand, enrollment applications and recertification requests include language that is not easily translatable. Participants who miss a deadline lose health care and prescription coverage, risking viral rebound and disengagement in health care coverage.

Failure to complete the eligibility recertification process is the primary reason ADAP participants have an interruption in their medical and prescription drug coverage. During the most recent one-year period, less than 1% percent of participants enrolled in NYS ADAP were deemed ineligible for program coverage due a change in income or other household circumstances.

During the most recent 12-month period, over 24,000 people were active in NYS ADAP. Due to the exceedingly small number of individuals with income changes precluding them from coverage and the short window of opportunity for health care coverage through marketplace open enrollment, recertifying eligibility twice per year yields no program savings and in virtually all cases interrupts care. Further, certifying eligibility only once per year preserves administrative time and effort that should more appropriately be focused on quality of care improvement and viral suppression. Considering the amount of effort and funding that is dedicated to linking and retaining PLWHA in health care, it is unconscionable to arbitrarily install a barrier to care within a program designed to provide medications and health care to the nation's most vulnerable individuals.

AIDS Outreach Center, Fort Worth, TX

I feel as though a six month update with our clients is creating a barrier. Most of our clients have to ride the bus for 2 hours to come for an appointment that takes 20 minutes. A self attestation can be mailed to the client but most of my clients will not send any supporting documentation back simply because they do not understand the self attestation. Clients receive SSI or SSDI and only receive a award letter once a year the most common thing I hear is "my income has not changed why do I have to keep giving you the same award letter"? I think it would be benefit the client if we could stop with the six month updates.

AIDS Project Worcester, Worcester, MA

[...]**

The services delivery structure today, is not like they were years ago [...]**. Today, there seem to be more Red Tape and barriers to accessing services for PLWH. I see why clients tend to not comply with medical care and/or medication adherence, go missing in action from the service delivery system, and is difficult for them to remain virally suppressed.

As a staff member of an ASO for over 12 years, it has been expressed to me by many clients that they feel harassed about providing the same information that was submitted to the agency months prior. This 6-month recertification has become burdensome for the clients that really need the services, but are denied because they do not meet eligibility requirements. What happened to someone being HIV+? Is that not requirement enough?

HIV services are supposed to support the PLWH, not make their lives more difficult. I am not sure who sits in Washington and make these decisions that impact the well-being and overall health of the PLWH. To me, these decisions are made by someone that is not impacted by HIV, someone who lives in a mansion, has a six-figure income, has a white collared job, has no care, compassion, or concern for the PLWH, and their objective at work is how they can hinder access to HIV services.

Why are we expecting PLWH to stay on top of bringing their HIV provider an updated income every 6 months when they are dealing with an array of other issues that affect their ability to be compliant with the recertification nonsense (not process).

On any given day, a PLWH can deal with issues, such as mental health, substance abuse, side effects from medications, domestic violence, legal issues, homelessness, comorbidities, or not have the skillset or capacity to ascertain the severity of consequences of not providing eligibility documents.

Ryan White Legislation exists to provide services to PLWH that needs them, not deny them services because they cannot produce an income (especially when their income has not changed within the year). The only way a PLWH income changes, unless they get $30 - $40 annual increase from social security.

The expectation of client's recertifying every 6 months is producing barriers for PLWH to access care. At the ASO that I am employed with, we provide clients with an ample amount of time to provide recertification documents and when the documents are not provided in a timely manner, it is a tough decision to have to decide whether or not to continue providing services to the PLWH that does not meet the eligibility requirement on one hand, and the other hand is to provide the service and not report it, which would impact the agency from meeting our projected scope of service numbers.

I would like for the powers to be to reconsider this grievous matter and remove the 6-month recertification process to allow PLWH to continue to thrive utilizing the services without all the Red Tape.

** denotes parts of the comments have been redacted

AIDS Resource Center of Wisconsin (ARCW), Milwaukee, WI

ARCW applauds HRSA HAB's stated goal of "seeking input to understand the impact and burden of the six-month recertification policy to assess RWHAP client eligibility for services. HAB is considering how to minimize the impact on patients' access to medical services, retention in care, access to HIV antiretroviral medications, and ultimately reaching viral suppression."

ARCW appreciates and understands the important distinction the RWHAP has a payer of last resort and that RWHAP funding must be spent on services for eligible individuals.

However, the six-month re-certification process presents time-consuming challenges for ARCW providers and patients and clients. For providers and staff, most of the burden for recertification falls on case managers who also play significant roles related to care coordination, retention and linkage to care, and have responsibilities related to quality metrics and viral suppression. Last year, ARCW served approximately 5,000 patients, almost all of whom were eligible for at least one Ryan White allowable service. Each of them required at least one verification event, as well as a re-certification, resulting in approximately 10,000 hours of staff time dedicated to eligibility certification and re-certification. This time, funded in part by Ryan White resources, could be much better spent assessing and responding to the healthcare, socioeconomic and programmatic needs of patients and clients. This is especially true considering that the financial situation of the overwhelming majority of ARCW patients and clients does not change in any meaningful way throughout the year.

The six-month certification burden is significant on patients and clients as well. More than 90% of ARCW patients and clients are living at or below 200% of FPL. Many of them are facing housing and food insecurity, are struggling to navigate a complex health care and social service infrastructure. Frequent asks for documents from staff not only at ARCW, but across all of the different health care, employment, and social service providers people with HIV may interact with on a regular basis is burdensome, confusing and creates a disincentive for engagement and adherence to HIV treatment regimens.

ARCW strongly encourages HRSA HAB to adopt an annual certification process for RWHAP services.

AIDS Services of Dallas, Dallas, TX

It would be fair to characterize the six-month recertification process as burdensome for both the agency and the clients we serve; furthermore, as a by-product and an unintended consequence, the level of encumbrance exerted upon our client base has a deleterious effect on the ability of agency staff to create and maintain an environment of effective cooperation and trust with the people we serve.

On this last point, and perhaps being the most important, it should be noted that our case management and other residential staff are expected to establish a positive working relationship, build trust and good-faith in order to motivate our base of formerly homeless, and in many cases, chronically homeless individuals towards positive steps in pursuit of independent living. These individuals are not always well-equipped to manage the stresses that our agency and other Ryan White funded agencies place on them on this seemingly endless loop of recertification. Please appreciate the level of consternation and, sometimes, anger this creates for our clients; they understandably direct this frustration at the very agencies that are there to help and assist and care. Unfortunately, the message at the very heart of the Ryan White Act gets lost in this maze of paperwork.

Regarding the first point, income, healthcare benefits, address, identification and so on simply do not change dramatically enough to warrant the level of scrutiny on a six-month basis. As a housing provider with supportive services, anytime any of these mentioned variables change, regardless of the time of year, our staff work to immediately address changes for verification purposes. Other agencies that do not have the same level of contact or inter-connectivity with a “captive” client base, may not be able to address changes as quickly; however, as mentioned earlier the Social Security Disability or Income amounts do not change mid-year; same with Medicare/Medicaid. For a vast majority of our clients (approximately 75%) their incomes are derived from Social Security. Nearly all of our client’s healthcare benefits are sourced from the above mentioned programs or Ryan White. These are all expressly static.

All providers need to do a better job of fostering an environment that encourages independence and graduation off of services that are no longer necessary. Furthermore, we should be very diligent in determining eligibility to maintain services for the greatest number of people with the greatest number of needs and urgency. As a community of funders and providers, we should be careful not be overzealous in this pursuit through cumbersome and repetitive procedural implementations. There are real-world negative consequences through such pursuit.

AIDS United, Washington, DC (AIDS Resource Center Wisconsin)

ARCW applauds HRSA HAB's stated goal of "seeking input to understand the impact and burden of the six-month recertification policy to assess RWHAP client eligibility for services. HAB is considering how to minimize the impact on patients' access to medical services, retention in care, access to HIV antiretroviral medications, and ultimately reaching viral suppression." ARCW appreciates and understands the important distinction the RWHAP has a payer of last resort and that RWHAP funding must be spent on services for eligible individuals.

However, the six-month re-certification process presents time-consuming challenges for ARCW providers and patients and clients. For providers and staff, most of the burden for recertification falls on case managers who also play significant roles related to care coordination, retention and linkage to care, and have responsibilities related to quality metrics and viral suppression. Last year, ARCW served approximately 5,000 patients, almost all of whom were eligible for at least one Ryan White allowable service. Each of them required at least one verification event, as well as a re-certification, resulting in approximately 10,000 hours of staff time dedicated to eligibility certification and re-certification. This time, funded in part by Ryan White resources, could be much better spent assessing the healthcare, socioeconomic and programmatic needs of patients and clients. This is especially true considering that the financial situation of the overwhelming majority of ARCW patients and clients does not change in any meaningful way throughout the year.

The six-month certification burden is significant on patients and clients as well. More than 90% of ARCW patients and clients are living at or below 200% of FPL. Many of them are facing housing and food insecurity, are struggling to navigate a complex health care and social service infrastructure. Frequent asks for documents from staff not only at ARCW, but across all of the different health care, employment, and social service providers people with HIV may interact with on a regular basis is burdensome, confusing and creates a disincentive for engagement and adherence to HIV treatment regimens.

ARCW strongly encourages HRSA HAB to adopt an annual certification process for RWHAP services.

AIDS United, Washington, DC (APLA Health)

The Ryan White Program six-month recertification policy is burdensome on both APLA Health employees who must do the work as well as on the patients and clients of the agency who access Ryan White Program funded services, and should either be simplified or eliminated. In some cases, recertification can be quickly accomplished, provided clients and patients are reporting no changes to address and income and when patient/client files are already in the agency's electronic reporting system. However, when programs or locations are not connected to an electronic data base — as is the case with APLA Health's Ryan White-funded food pantry — recertification forms must be completed by hand and later transferred to electronic files. Clients frequently report income changes that do not impact their eligibility for Ryan White services, but nonetheless they may have to go to local Social Security offices to obtain a print-outs to report income changes, sometimes as little as $3. Staff at APLA Health's food pantry and dental clinics report that younger clients and patients are generally more adept at securing the documents they need online, but that older clients often have more difficulty and spend more time retrieving hard copy documentation. Anecdotally, the manager of APLA Health's Ryan White oral health program, which sees several thousand unique patients each year, could not recall a single instance of patient eligibility for the program changing, based on recertification.

AIDS United, Washington, DC (Legacy Community Health)

Legacy appreciates HRSA's request for input regarding the burden of the six-month recertification policy to assess RWHAP client eligibility for services. Lessening the burden of requiring six-month recertifications for all Ryan White patients would eliminate the need for significant staff resources required to perform them, and would ease the burden on patients that have minor changes in income or healthcare coverage and still qualify for the program. We recommend HRSA allow patient self-attestation to notify providers of minor changes in income or healthcare coverage, and encourage the removal of the six-month recertification process when minor changes do not disqualify patients from the program.

Alabama Dept of Public Health, Montgomery, AL

Alabama's Ryan White HIV/AIDS Program (RWHAP) commends HRSA's recent request for information (RFI) to streamline administrative procedures and reduce burden.

Requiring twice a year eligibility recertification of this under-served, vulnerable, and hard to reach population creates barriers to care and inhibits progression along the HIV care continuum towards achieving and maintaining viral suppression. Persons living with HIV (PLWH) who achieve and maintain viral suppression are 96 percent less likely to pass HIV on to their sexual partners. For PLWH who have reached undetectable levels, there are no documented cases of sexual transmission. This is the premise of the Prevention Access Campaign's Undetectable Equals Untransmittable (U=U) initiative, which the Centers for Disease Control and Prevention supports agreeing there is "effectively no risk" of sexually transmitting HIV when on treatment and undetectable. For the first time ever, we have the tools to end the HIV epidemic!

PLWH receiving RWHAP AIDS Drug Assistance Program (ADAP) and Part B core medical and support services experience improved retention in care and viral suppression compared to all PLWH in Alabama. While preliminary 2017 data show retention in care and viral suppression among all PLWH in Alabama is only 54 percent, clients receiving ADAP and Part B core medical and support services fare much better. In fact, clients receiving ADAP and Part B services are quickly approaching the National HIV/AIDS Strategy (NHAS) 2020 indicator of 90 percent retention in HIV medical care and many have already surpassed the NHAS 2020 indicator of 80 percent viral suppression. This proves the effectiveness of the RWHAP! By enrolling all eligible PLWH into Alabama's RWHAP, the number of PLWH retained in care and virally suppressed will increase and the number of new HIV infections will decrease.

Unfortunately, getting eligible PLWH enrolled into the RWHAP is only one step in helping this vulnerable and hard to reach population. Keeping eligible clients enrolled in the RWHAP is a battle. In Alabama, the primary reason for losing access to ADAP and Part B services is disenrollment due to failure to recertify. The majority of these disenrolled clients do not experience income or healthcare coverage changes significant enough to disqualify them from RWHAP services, they simply miss their twice a year eligibility recertification requirements. This results in inconsistent HIV care and avoidable disruptions in antiretroviral adherence. As previously stated, PLWH represent a very vulnerable and hard to reach population. Many PLWH are transient, and even those with stable housing often experience frequent moves and/or changes in contact information and cellular phone numbers. While Alabama agrees requiring an annual eligibility assessment to ensure the RWHAP remains the payor of last resort is necessary, requiring an additional six-month recertification creates unnecessary burden and barriers for PLWH to receive continuous HIV medical care and support services.

Alabama's RWHAP ADAP and Part B respectfully requests reconsideration and removal of the burdensome six-month eligibility recertification requirement. Many other federally funded programs in Alabama aimed at improving the health and nutrition of vulnerable populations require only an annual eligibility screening (e.g., the Children's Health Insurance Program (CHIP); the Women, Infants, and Children (WIC) food and nutrition service; the Supplemental Nutrition Assistance Program (SNAP). Imposing additional eligibility requirements on PLWH receiving RWHAP services beyond those required for consumers of other federal funded programs is unnecessary and inhibits national progress towards ending the HIV epidemic.

Again, Alabama commends HRSA for soliciting responses to this RFI and addressing this issue. On behalf of Alabama's RWHAP ADAP and Part B program and the PLWH in Alabama this program serves, we look forward to a favorable response.

Sources:

http://www.alabamapublichealth.gov/hiv/assets/ADAPAnnualReport_2017.pdf (PDF - 428 kb)
http://www.alabamapublichealth.gov/hiv/assets/HIVContinuumCare_2017_Preliminary.pdf (PDF - 468 kb)

AT Still University, Kirksville, MO

A 6 month re-enrollment/re-certification for HAB services creates significant burden for patients accessing services and can lead to a disruption of much needed services and care for this population. Any efforts to minimize the requirements of re-certification would reduce patient and provider burden.

Beth Israel Deaconess Hospital Plymouth, Plymouth, MA

The ACCESS HIV/AIDS Program receives both Part A and C funding to provide care to people living with HIV/AIDS in the Plymouth MA area. Our team has reviewed the RFI on burden reduction and have the following comment pertaining to RFI section C.3.

As Part A recipients, we believe the 6 month certification has been beneficial for a few reasons. The 6 month reassessment, HDAP application and RW Dental applications provide us with an opportunity to update patient labs, social service needs, ISPs, and ensure that patients are seeing their medical provider on a regular basis. The 6 month appointment also encourages patients to seek us out if there is an issue they may need help in resolving.

The downside of the 6 month recertification is that some clients find it very difficult to submit the many documents needed every 6 months. This results in deferment of services until a crisis happens. When the crisis occurs, they re-engage with case managers, only to fall out of service again when the crisis is resolved.

Perhaps a compromise would be an annual once full recertification that includes proof of income, residence and insurance followed by a brief 6 month recertification that does not require document submission unless there has been a change. This could reduce paper burden for staff and reluctance for clients having to obtain documents o often for each different program.

Boston Public Health Commission, Boston, MA

Six-month recertification of client eligibility introduces an unnecessary reporting burden. This policy provides little benefit to clients accessing services, adds additional administrative time and effort to programs, and does little to prevent ineligible clients from accessing services.

Program monitoring is required and time-intensive. Over 800 client records are reviewed annually through on-site compliance visits, representing 15% of all client records. For the last three years, records reviews have produced at most 1-2 patient records annually that significantly lacked sufficient service eligibility documentation. These files represent less than .1% of all clients accessing services. In each case, providers were able to produce appropriate eligibility documentation for their clients in a timely manner following an on-site visit.

Re-certification focuses on 3 key areas: residency, insurance status, and income.

Residency: HRSA provides little guidance on residency documentation. Yet, it is exceedingly rare to encounter a record for a client who cannot show in some form or another that they live within the EMA’s region. Clients must demonstrate residency (and income) to qualify for the state Medicaid programs, and most clients accessing Ryan White are receiving this support. Therefore, requiring proof of residency and income for Ryan White is often redundant.

Insurance: Due to health care reform in our service region, over 97% of clients have some form of insurance coverage and maintain it throughout the year.

Income: Comprehensive annual visits and data reported by service providers demonstrate that most Ryan White clients live at or below 200% of the federal poverty line, with little change year to year. Income level rarely changes for most clients and for many, documentation is only made available to them by the social security department annually. Most Ryan White clients rely on public benefits to meet their most basic needs, and often are only able to access this income source through support by Ryan White providers. Several subrecipients stress the difficulty of obtaining income verification on a 6-month cycle for clients that experience immigration issues, chronic homelessness, severe substance use, and mental illness. Engaging clients with such acute needs requires trust-building, which can be hampered by an overemphasis on documentation. Lastly, to be compliant with HRSA policy, some programs may choose to screen out clients who miss the 6-month certification window, but ultimately end up re-enrolling them after they prove to be eligible for services a month or two later. This increases the risk of service discontinuity.

While it is understood that eligibility for services is a legislative requirement, the 6-month frequency of recertification offers little benefit to our service region at this time.

Broward County, Ryan White Part A Program, Fort Lauderdale, FL

Clients already bear the challenges of having multiple appointments and multiple eligibility processes (Part A, ADAP, food bank, etc.) which is further compounded by poor access to transportation. Recertification should be done if there is a qualifying event (which would need to be determined). The costs savings realized by not having a six month recertification should be repurposed to maximize services that have a direct impact on retention.

CAEAR Coalition, Washington, DC

The eligibility screen can create barriers to care and service delivery. It can also feel unnecessary and burdensome to clients whose income rarely, if ever, changes. (Many are on public benefits that do not change or their incomes are so far below most jurisdictions' eligibility criteria that it would be nearly impossible for their income to change enough to be ineligible.) The six-month re-certification requirement should be eliminated. Jurisdictions should have greater leeway to develop their own eligibility re-certification policies, including how often re-certification is needed. They should be able to address local factors, such as client/patient demographics, local eligibility criteria, and service categories. For example, stricter criteria for those that are possibly reimbursed by Medicaid.

California Department of Public Health, Sacramento, CA

The impact of six-month recertification on California AIDS Drug Assistance Program (ADAP)

To meet the six-month recertification requirement, California ADAP uses a selfattestation approach by developing a Self-Verification Form (SVF) that is mailed to clients 45-days before their six-month recertification eligibility end date. The SVF requests that the client validate their residential address, income, and health coverage (i.e., Medi-Cal, Medicare, and/or private insurance). If the information remains unchanged, then the client signs the SVF attesting that the information is still accurate and mails the signed and completed form back to ADAP. If the information has changed, then the client needs to schedule an appointment to meet with their ADAP enrollment worker to update the information and provide the supporting documents that are associated with the change. The six-month recertification process is a very labor- and time-intensive process. At times, the six-month recertification can also become a barrier to clients to being retain in care.

SVFs are extremely time sensitive and are mailed monthly, requiring program staff to run queries to generate mailing lists containing the most recent mailing address of each client that is due for a six-month recertification. Program staff then conduct a quick quality assurance review to ensure there are no major mailing address issues that would prevent the SVF from being delivered. ADAP is looking into implementing an address validation tool in the ADAP Enrollment System (AES) to improve data accuracy. After review, program staff must complete an order form to initiate the mailing process with California's Department of General Services (DGS), Office of State Publishing (OSP). The OSP facilitates the mailing of ADAP's SVF to all ADAP clients. Approximately 1,500 to 2,000 SVFs are mail each month.

There are times the SVF is incorrectly or incompletely filled out by the client and mailed back to ADAP for processing. The client may indicate no changes on the SVF but upon ADAP's review, based on the client's comments, it is clear there is a change. There are also times when the client completes the SVF correctly, but forgets to sign the SVF to attest the information provided is accurate. In these circumstances, ADAP cannot process the SVF and an ADAP Advisor must reach out to the ADAP enrollment worker to follow-up with the client. The enrollment worker will need to schedule an appointment with the client to meet at the enrollment site to redo the SVF. During the appointment, the enrollment worker would also provide guidance to the client on how to properly fill out the SVF to avoid future disruptions in eligibility. Clients are consider delinquent for their six-month recertification until the SVF is accurately completed, which could lead to a lapse in eligibility. The SVF process can be especially burdensome for clients who are homeless or who do not have stable housing because the client may not receive their SVF or the ADAP enrollment worker and ADAP advisor may have difficulty contacting the client to have the SVF corrected prior to the their eligibility lapsing.

Clients often forget about their annual six-month recertification date, as it is aligned with the client's half-birthday (six-months before the client's birthday), when compared to their annual re-enrollment date, which is aligned with the client's birthday. Clients who lapse in their six-month recertification are required to reapply to ADAP and, if applicable, ADAP's insurance assistance programs. Often time this becomes a barrier for the client, especially for clients who do not have health coverage and rely on ADAP's assistance as their sole source for antiretroviral medication.

ADAP's insurance assistance programs consist of the Office of AIDS-Health Insurance Premium Payment (OA-HIPP) program, the Employer Based-Health Insurance Premium Payment (EB-HIPP) program, and the Medicare Part D Premium Payment Program. The OA-HIPP and EB-HIPP program assists clients with their health insurance premiums and the employee's portion of the health insurance premium, respectively. While the Medicare Part D Premium Payment Program assists clients with their Medicare Part D premiums and, if applicable, their Medigap premium. ADAP's insurance assistance program also assist clients with their medical out-of-pocket costs. Clients who enroll in ADAP's insurance assistance programs often have difficulty even paying one month of insurance premiums. For these clients, it would be difficult to overcome the financial hurdle of paying their own health insurance premiums and medical out-of-pocket costs if there is a lapse in their eligibility. This could potentially lead to the loss of the client's health coverage and affect the client's ability to access medical care, and prevent the client from achieving or maintaining viral suppression.

The impact of six-month recertification on HCP sub-recipients:

  • Sub-recipients express challenges with trying to manage the six-month recertification as not all clients need to be seen as frequently and the timing of appointments does not always match the strict six-month requirement.
  • Sub-recipients continue to struggle with the burden of having to have clients who are stable come in to the office to provide eligibility documents for the annual recertification. We have been asked if clients can submit documentation electronically, rather than in person.
  • Anecdotally, sub-recipients report that the vast majority of their clients do not experience significant enough changes to disqualify them for RWHAP eligible. It may be useful for HAB to conduct a study to quantify the degree to which clients become ineligible at the six-month recertification and for which reasons. This may help HAB to better streamline the six-moth recertification requirement.

California Primary Care Association (CPCA), Sacramento, CA

The six-month recertification policy to assess Ryan White eligibility is extremely burdensome and should be changed. As California has fully implemented health care reform, Ryan White consumers do not experience significant shifts in health care coverage due to minor fluctuations in income. Further, as the vast majority of Ryan White consumers have other health and mental health issues, it has been increasingly difficult to get consumers to recertify through the mail or in-person. While we have tried to make the six-month recertification as easy as possible, it increases time and resources spent by enrollment workers and is a barrier to patients.

CPCA member health centers request that recertification be simplified to a periodic attestation of eligibility. This would include a standard question asking if there are any changes to the patient’s eligibility, which will be asked at each encounter, instead of a periodic redetermination process. This would require less paperwork and time spent recertifying by enrollees and health center staff.

If we cannot move to a periodic attestation of eligibility at each encounter, we ask that HRSA move to an annual certification. Returning to annual recertification would decrease the burden on enrollment workers and consumers. It would also align Ryan White recertification with Covered CA (California's health exchange) and Medi-Cal.

CAN Community Health, Inc., Sarasota, FL

Minimizing the impact of RWHAP eligibility certification on patients, however, is worthy of further exploration. In section C.3, HRSA's RFI indicates that RWHAP is considering eliminating the six-month recertification requirement related to income and insurance status for Ryan White recipients. There is no doubt that eliminating this requirement will reduce burden and increase efficiencies for grant recipients and sub-recipients. Removing the need to re-certify more than once a year essentially removes a barrier to care, especially in those areas where care and eligibility are not provided in the same facility. Removing this requirement will also reduce the impact of transportation as a barrier.

Central Carolina Health Network (CCHN), Greensboro, NC

The requirement for Ryan White clients to recertify every six months should be updated to reflect changes in standards of care and to lessen the burden on clients and grant recipients. If HAB would like the Ryan White program to align more closely with other needs-based programs, the ACA marketplace, or private insurance plans, they should move to a once annually certification process. We find that our client's financial status does not change drastically within a year (or year to year) to necessitate a six-month recertification process. Additionally, many clients that have been virally suppressed for years on the same medications may be scheduled for a follow-up appointment with their infectious disease doctor at nine-month intervals instead of six months. Although this is a positive outcome in terms of their health and management, these clients may miss the recertification window, and receive delays in care when they return to the clinic for services. Other needs-based programs with frequent recertification intervals or extremely burdensome certification criteria often see steep drop offs in program enrollment. In the case of the Ryan White program, this has serious implications for public health and the spread of HIV. HAB should consider once a year certification to ensure that clients can achieve uninterrupted access to services.

City of New Orleans, Office of Health Policy and AIDS Funding, New Orleans, LA

New Orleans EMA strives to ensure Ryan White funds are funds of last resort by ensuring clients are diligently screened for third party payor. While we appreciate the spirit of the requirement to rescreen clients every six months, this rescreening process is a hardship for some clients and frontline staff serving PLWH such as clients who are transient and receives cash or has no income and agencies with high caseloads. Self-attestation can only be used once a year, but some clients are homeless and continue to be so after six months. For example, an undocumented client who did not have any documentation in her name because she was living with a friend and paid the friend in cash for rent and utilities. Most Part A clients are 300% and below, and their income does not change every six months. The following are comments from providers and frontline stakeholders regarding the six-month recertification requirements.

HIV Cancer Care Program

As a community organizer and direct service provider for PLWHA, I can attest from both personal and professional interactions that the 6 month re-certification process for the RWHAP is burdensome for both clients and service providers. Many of our clients struggle with access to transportation, child care, getting time off work for various health-related appointments, and being able to procure necessary documents to verify RW eligibility. From a service provider standpoint, this creates challenges in scheduling and rescheduling missed appointments for re-certification, as well as having to keep continuous outreach to clients who are only able to provide partial documentation/who are challenged by being able to provide primary documentation. In addition, when considering case manager case load, bi-annual re-certification creates an additional burden in keeping track of client eligibility when there is frequently little to no change in our clients' income, especially for those surviving on SSI. Systems challenges aside, the true affect is felt when a client's certification lapses and a gap in medication access arises. We in the New Orleans EMA are proud to have collectively brought our community viral suppression to 84% for those in care- any opportunity to minimize barriers in increasing viral suppression and assisting those who have reached it to maintain their undetectable status should be taken into serious consideration. I have no doubts that annual re-certification, as opposed to bi-annual re-certification, would assist us in reaching that goal.

CrescentCare – Multiple feedback from case managers

  • Some clients report feeling burdened by a high volume of paperwork that seems redundant.
  • If self-attestation can only be accepted one time in a 12-month period and "appropriate documentation" is required for one of the recertification events, what is acceptable as “appropriate documentation” (especially for individuals who are living on the street/transient and/or have zero income or work for cash/tips that isn't reported, etc.)? We've moved away from obtaining an affidavit because an affidavit does not make a self-report of income or residence any more true/reliable/valid.
  • A number of clients we serve face great instability and may only present when in crisis. They're not necessarily equipped at that time with verifications of income and residency, and may not be in an appropriate condition to complete eligibility re-screening.
  • On the flip side of that situation, PLWH are living a much more healthier lives than before. There are a large percentage of clients that aren't scheduled for Primary Care services more than once every 6 months. Doing a 6 month renewal process could cause barriers to care. Clients would have to update paperwork before coming in for a regular appointment or have to reschedule a primary care appointment so that they can get the paperwork completed.
  • It is only an extremely small subset of the population who become qualified or disqualified for RWHAP over the course of a 12-month period of time.
  • In the RWB system, there is a hard-stop in which LA HAP stops providing services if 6-month certification is not completed. In the RWA system, there is no hard-stop, and it's easy to miss completing re-certification and/or updating LaCAN given the number of competing priorities that must be factored in.
  • The RW system is rooted in a model in which most/all eligibility screening and access to services relies on RWHAP program staff. Clients do not have an efficient mechanism to self-manage eligibility screening and the various RW systems are disconnected in terms of sharing information regarding eligibility. Improvements are being made, but this will be a large systems change and rely on technology that is both accessible to our clients and connects to our programs.
  • Volume presents a bottleneck given this re-screening requires meeting with RWHAP staff in the RWA system.
  • Clients with consistent income, notably SSI/SSDI, rarely experience a significant change in income over the span of several years' time let alone in a 6-month period of time. It seems that SSI/SSDI recipients in particular could have an eligibility determination made more efficiently. Further, especially in the case of SSI, it seems that RWHAP eligibility could be presumed (as is the case for RWB…no SSI income proof or SNAP proof is needed).

Belle Reve

I agree the 6 month can be burdensome as most of our clients do not experience major income changes that would deem them to not be qualified. As far as CD4 and Virals, one major problem is receiving current labs from the client’s providers which only makes it seem as if they had fallen out of care. Another obstacle is receiving referrals with outdated labs.

University Medical Center

From our clients we hear of the inconvenience of having to come in so soon when nothing has changed. Many have transportation issues that are burdensome and cause clients in many cases to miss the "update" appointment which can delay access to needed Ryan White resources. Additionally, we have a number of RW individuals that are accessing other federal programs such the ACA, Medicare, Medicaid and financial disability assistance from SSA that allow for yearly renewals and enrollments which are confusing to our clients.

Priority Health Care

Dependent on the size of the caseload, we are sure that many recertification dates are missed or late because the dates can vary so drastically. While we are sure that the six month recertification was developed for specific reasons, it feels like it is something that is already being addressed in other areas.

C​ommonwealth of Kentucky HIV/AIDS Branch, Frankfort, KY

Under RFI C.3 this is a real challenge anyway you go. Currently, we have adopted a No change form that the client can sign at the 6 months if there is no change to address. Medical insurance, income or

Household size. We use a ROC(Report of Change) if there is any change to any of the following; address, income, insurance or household size with the supporting documentation uploaded as well as the ROC.

I think it is a good practice to meet with clients at least every 6 months. The issue we run into is that clients fail to come in before the end of the expiration month we decertify and then in about 1 – 2 weeks

They try and get their medications and come in and update for failure to recertify. It would be nice if we could have a grace period as we have done a sample and when we decertify about 100 clients usually

By 2 weeks into the new month we have had at least 60% return to care.

Community Clinic Association of Los Angeles County (CCALAC), Los Angeles, CA

The six-month recertification policy to assess Ryan White eligibility is extremely burdensome on both health center staff and patients and should be changed.

As California has fully implemented health care reform, Ryan White consumers do not experience significant shifts in health care coverage due to minor fluctuations in income and health centers report that virtually none of their patients' eligibility changes based on this recertification. Also, due to other health and mental health issues, it can be extremely difficult to get Ryan White consumers to complete the recertification process. The process requires time and resources on the part of both health center staff and patients. It is particularly challenging for patients who are unable to obtain needed documents online and have to take steps such as going to local Social Security offices to obtain hard copies of income documents.

For these reasons, we recommend recertification be simplified to include a standard question asking if there are any changes to the patient's eligibility, which could be asked at each encounter, instead of a periodic redetermination process. This would require significantly less paperwork and time for both program enrollees and health center staff.

If a periodic redetermination is needed, we recommend that HRSA move to annual certification. This also would decrease the burden on both staff and patients. It would also align Ryan White recertification with Covered California (California's health insurance exchange) and Medi-Cal (California's Medicaid program), both of which require only annual redetermination.

Craig Dalsimer Division of Adolescent Medicine at Children's Hospital of Philadelphia (CHOP), Philadelphia, PA

As the director of Adolescent HIV Services (Dr. Dowshen) and an attending physician (Dr. Wood) for the Craig Dalsimer Division of Adolescent Medicine at Children's Hospital of Philadelphia (CHOP), we appreciate the opportunity to provide comments on the proposed Request for Information: Administrative Streamlining and Burden Reduction published by the Health Resources and Services Administration, in regards to Executive Orders 13771 and 13777. CHOP is the nation's largest pediatric health care network with over 50 locations for primary and subspecialty care throughout Pennsylvania and New Jersey.

Our comments specifically address the question raised in Section C. HRSA's HIV/AIDS Bureau (HAB) of this RFI regarding the burdens associated with the biannual recertification for Ryan White service eligibility. A solid body of evidence shows that requiring too frequent administrative processes to renew eligibility for health care services is detrimental to continuity of care and leads to poorer health outcomes. Our own recent research conducted at CHOP demonstrates that youth living with HIV have high rates of gaps in care. During these commonly occurring periods out of care, patients do not have access to case management services for Ryan White re-application, often further delaying care. This loss can result in poor medication adherence, jeopardize individual health, increase the risk of HIV transmission, and ultimately increase health care costs. Additionally, the agencies that must process the Ryan White recertification applications experience a greater administrative burden due the volume and frequency of applications and the regular gaps in coverage that often occur.

Moving to a 12 month eligibility model, as could be done for the Ryan White program, has already been shown to be successful in studies regarding Medicaid coverage. A study of selected states moving from a 6-month to a 12-month eligibility enrollment showed a decrease in administrative costs and the disenrollments and reenrollments processed by the states' Medicaid programs.i A study done in 2014 used Wisconsin Medicaid enrollments from 1999 to 2012 to show that extending redetermination from 6 to 12 months reduced compliance costs.ii Similarly, a 2015 simulation study of Medicaid enrollments showed that increasing the continuous eligibility to 12 months decreases Medicaid exit and re-entry of beneficiaries, referred to as "churning", and increases the amount of people covered over that year period.iii Strengthening continuity of coverage in the same way for Ryan White services will likely yield similar positive health and administrative outcomes.

The Ryan White HIV/AIDS program has an extensive reach servicing vulnerable populations in need of HIV-related care. According the 2016 Ryan White program highlights, 65.4% of those served live at or below 100% of the federal poverty line, and many are adolescents and young adults.iv More than 25,000 individuals between the ages of 13 – 24 are able to obtain services nationwide by Ryan White clinics,v with about 25% of those young people getting their care in Pennsylvania.vi Here at CHOP, alone, there are currently over 100 adolescents and young adults served by our Ryan White-funded clinic, with more than 300 young patients receiving care through our programs over the past 10 years.

Vulnerable populations, such as adolescents and young adults who have difficulty accessing and adhering to their medications, are in need of continuous access to Ryan White coverage which provides intensive psychosocial support, such as counseling and referrals for housing and nutrition, as well as free or reduced cost antiretroviral therapy – which is critical to both maintaining individuals’ health and preventing HIV transmission. According to a 2016 study in Clinical Infectious Diseasesvii, Ryan White access was necessary to fill gaps in coverage that remained despite expansion of Medicaid in many states and increasing private insurance coverage rates. This finding emphasizes the need for continuous coverage, especially in this population.

A separate 2016 study showed that individuals receiving their antiretroviral coverage through the Ryan White AIDS Drug Assistance Program (ADAP) are more likely to achieve viral suppression, the gold standard outcome of HIV treatment, compared to individuals with Medicaid or private insurance coverage.viii Viral suppression improves health and life expectancy, and halts disease progression for people living with HIV. Importantly, it also eliminates the possibility of transmission of HIV. Centers for Disease Control and Prevention (CDC) data demonstrate that only 48-57% of adults over the age of 35 living with HIV have achieved viral suppression. For adolescents and young adults, this number is only 28%.ix

Our research at CHOP further supports the need to reduce barriers for individuals seeking Ryan White services. Last year, we conducted a study of youth who had received HIV care at our clinical site to determine the role of insurance on reducing HIV transmission risk, which we defined as lack of viral suppression with a co-occurring sexually transmitted infection. This study, published in the journal AIDS this year,x identified that youth with insurance coverage, when defined including Ryan White ADAP coverage, had a more than 50% reduction in the odds of being at high risk of transmitting HIV over a 13 year period. When we repeated our analysis taking Ryan White ADAP coverage out of our definition of insurance, this protective effect was diminished. This finding demonstrates that it is the treatment safety net provided by Ryan White that may reduce HIV transmission risk. These data demonstrate that Ryan White services are critical in reducing in controlling the HIV epidemic.xi

The requirement to reapply for Ryan White eligibility every 6 months creates an increased burden that is felt by the individual accessing care and across the entire health care system. Youth living with HIV often experience many competing needs, including high rates of housing and food insecurity, and these needs will often take priority over renewal of health care benefits. A 2015 study of individuals living with HIV in a county with extensive Ryan White funding showed that the loss of insurance coverage was the most common barrier to care and treatment. Our recently published 2018 study also showed that there is an association between insurance coverage gaps and being at risk for transmitting HIV.

Furthermore, the reapplication process puts a burden on the administrative system. Ryan White medical case managers and health care organization administrative staff spend significant time assisting with renewal and confirmation of benefits. This time could be better spent working with youth to improve adherence and engagement in their medical care and well-being.

Ryan White services are an essential tool in improving health outcomes and preventing the spread of HIV. We should work to minimize potential barriers to accessing these services whenever possible. The current six month re-application requirement is a challenge for many individuals as issues with work, housing, transportation, or finances, among other factors, may make it difficult or impossible to complete the process so frequently. Preventing interruptions in access to Ryan White care is essential in curtailing the HIV epidemic in the United States, especially among adolescents and young adults. Additionally, a reduced administrative and time burden to health care systems and staff has the potential to lower healthcare costs, and shift focus to providing the highest value care and improving outcomes for people living with HIV.

We applaud HRSA for considering elimination of this six-month reapplication requirement, and urge that it be replaced with a policy of at most a yearly reapplication process that will promote administrative efficiency, continuity of care, and greater health outcomes for the most vulnerable populations. We are available for follow up questions if needed via our contact information below.


i Irvin C, Peikes D, Trenholm C, Khan N. Discontinuous Coverage in Medicaid and the Implications of 12-Month Continuous Coverage for Children, Final Report. Mathematica Policy Research Inc. 2001.
ii Moynihan D, Herd P, Harvey H. Administrative Burden: Learning, Psychological, and Compliance Costs in Citizen-State interaction. Journal of Public Administration Research 2014;25(1):43-69. DOI: 10.1093/jopart/muu009
iii Swartz K, Farley Short P, Graefe D, Uberoi N. Evaluating State Options for Reducing Medicaid Churning. Health Aff (Millwood) 2015;34(7):1180-1187. DOI: 10.1377/hlthaff.2014.1204.
iv Improving Health Outcomes Through Data Utilization: 2016 Ryan White HIV/AIDS Program Highlights. Health Resources and Services Administration website. https://hab.hrsa.gov/sites/default/files/hab/data/biennialreports/2016_HRSA_Biennial_Report.pdf. 2017. Accessed June 20, 2018.
v Ryan White HIV/AIDS Program Annual Client-Level Data Report Ryan White HIV/AIDS Program Services Report (RSR). Health Resources and Services Administration website. https://hab.hrsa.gov/sites/default/files/hab/data/datareports/RWHAP-annual-client-level-data-report-2016.pdf. 2017. Accessed June 20, 2018.
vi RSR Client Characteristics in Pennsylvania in 2015. Health Resources and Services Administration. https://hab.hrsa.gov/stateprofiles2015/#/profile. 2015
vii Berry SA, Fleishman JA, Yehia BR, et al. Healthcare Coverage for HIV Provider Visits Before and After Implementation of the Affordable Care Act. Clinical Infectious Diseases 2016;63(3):387-95. DOI: 10.1093/cid/ciw278
viii Bradley H, Viall AH, Wortley PM, Dempsey A, Hauck H, Skarbinski J. Ryan White HIV/AIDS Program Assistance and HIV Treatment Outcomes. Clinical Infectious Diseases 2016;62(1):90-98. DOI: 10.1093/cid/civ708
ix HIV Continuum of Care, U.S., 2014, Overall and by Age, Race/Ethnicity, Transmission Route and Sex. Centers for Disease Control and Prevention website.
x Wood S, Ratcliffe S, Gowda C, Lee S, Dowshen N, Gross R. Impact of insurance coverage on HIV transmission potential among antiretroviral therapy-treated youth living with HIV. AIDS 2018;32:895-902
xi Bradley H, Viall AH, Wortley PM, Dempsey A, Hauck H, Skarbinski J. Ryan White HIV/AIDS Program Assistance and HIV Treatment Outcomes. Clinical Infectious Diseases 2016;62(1):90-98. DOI: 10.1093/cid/civ708

Department of State Health Services, Texas Part B, Austin, TX

  • The Texas HIV Medication Program (THMP) has over 22,000 participants. HRSA eligibility guidelines require that RWHAP recipients are recertified annually and complete a self-attestation at the six-month mark. The burden to the state is significant, with over 44,000 recertification actions for THMP alone, required annually. THMP has received feedback from both community agencies and program participants reporting that six-month self-attestations and annual recertification requirements for RWHAP with THMP represent a burden for program participants.
  • The Texas HIV Medication Program (THMP) has over 22,000 participants. HRSA eligibility guidelines require that RWHAP recipients are recertified annually and complete a self-attestation at the six-month mark. The burden to the state is significant, with over 44,000 recertification actions for THMP alone, required annually. THMP has received feedback from both community agencies and program participants reporting that six-month self-attestations and annual recertification requirements for RWHAP with THMP represent a burden for program participants.
  • The majority of participants in the THMP are below 100% of the federal poverty line and are uninsured. Participants are often unstably-housed and lack a stable mailing address for program materials to be mailed to reliably.
  • The THMP is unable to provide a grace period or presumptive eligibility due to grant requirements. Because of this, program recipients who have moved, do not respond to recertification application requests, or provide incomplete information are dropped from the program. This results in participants needing emergency medication assistance at the local level temporarily, lapsing medication treatment temporarily, or disengaging from medication treatment completely. These results are troubling and disproportionately impact those who are most difficult to engage in care.
  • THMP serves a population that overwhelmingly continues to be eligible for services. It is our belief that recertification every two to three years would ensure payer of last resort while eliminating needless stress and loss of services for those most in need of services. We urge HRSA to consider the burden of this eligibility policy.
  • Biannual eligibility screening is by far the biggest burden providers, patients, the ability to spend-down of funds, and the utilization of RWHAP services by providers and patients. As a medical provider, many patients fall off RWHAP at the six-month mark; however, we are obligated to continue to provide services, including medications, which eats at our overall organizational budget. In total last year alone, we lost about $1,095,420.53 in bridging medications to patients who had missed the 6-month eligibility screening for RWHAP and ADAP. As a larger organization we are able to do this, but this not only hurts our ability to grow services, it also cripples smaller organizations.
  • Biannual screening is complicated for patients for a number of reasons, one being that every other benefit program, including other state and federal grant programs, only require annual screening. For organizations working to ensure they have up-to-date screening information, many personnel and financial resources are directed toward eligible screening. These resources are not fully-funded by RWHAP and can be used to support other patient navigation support services.
  • At this point, six-month recertification is an unnecessary administrative burden that discourages clients from engaging in care. A client's financial, residency, and insurance status does not often change in a years' time. Changing to an annual eligibility screening would increase access and reduce the burden for both the client and the provider.
  • The motivations that led to the existing annual/6-month recertification process is understood and mostly agreed with. Furthermore, the enhanced focus on ensuring eligibility requirements are met is also understood and supported. However, the downside to these requirements may be having an undesirable effect on clients and providers that potentially outweighs the benefits.
  • Due to the six-month recertification requirements, an increased number of clients are being discharged from services for non-compliance, or are becoming lost to follow-up.
  • The consensus among clients is that the new requirements (every six months) are more burdensome and redundant than doing it annually.
  • The degree of administrative work required to ensure that the requirements are met every six months is extensive. Does the data show that there has been a significant increase in eligibility being kept current? If so, at what ratio to client discharges/lost to follow up?
  • If the requirements for annual eligibility are maintained and strictly enforced, that there is no discernable benefit to keeping the six-month recertification process; rather, it may have detrimental effects on the overall goal of retention in care.
  • The Regional TX/LA Part A/B Group are all in agreement that the recertification process is extremely burdensome on clients and service providers. We all strongly support there NOT being a recertification process. The current recertification process for both Ryan White and THMP is extremely cumbersome on our clients, especially given the fact that not much changes for them in a six-month period.

EVMS Medical Group, Norfolk, VA

I agree that it is burdensome to clients as many of their clients do not experience income or healthcare coverage changes significant enough to disqualify them for RWHAP services. We are working with close to 2500 clients in a year. By the time all of the clients have updated the first time, it is time to update all of them again with very little change in the updates. If there were significant change or more change within the population we serve, then I could understand the need or desire to have updated information a second time in the year. However, there are not significant changes in their poverty level so the information collected a second time is almost identical to all the information collected the first time and it burdensome to clients and to staff to obtain the same information from thousands of clients that was just obtained a short time ago.

Family Health Council of Central PA, Camp Hill, PA

As a regional HIV program manager and a former agency level program manager, I have seen the effects of the recertification both on the client level and on the administrative level. On both the client level and administrative level, the most common thing I’ve heard is the question around why they have to go through this process when they already provided all of these items during the intake process.

You need to know and understand that HIV staff don’t just let random clients into the HIV program for services. The people that we serve are truly in need and by requesting this additional information you are creating not only an undue burden on the client but you are adding a sometimes stigmatizing and trauma inducing event to this person’s life. Trauma informed care providers know that administrators can inflict trauma just by nature of the forms we ask for. By having to recertify clients every six months they are reminded of their HIV status again and again.

In addition, client income and insurance does not drastically change over time. Their identity doesn’t change at all, so why are we asking for this information repeatedly. It creates another barrier to care. If a client cannot get the information to the agency in a timely manner they can lose much needed services. Around 75% of the clients I work with are under 100% of poverty and are more concerned about where their next meal is coming from than trying to gather paperwork to bring to their providers. I cannot stress enough the barrier this creates. A client who doesn’t turn in their paperwork on time can lose much needed benefits that keep them in care and help them maintain their adherence to medications. I have seen firsthand, clients who have increased viral loads just because they have not been able to get the paperwork to the agency that they need for recertification.

Please trust that the HIV providers know what they are doing and are providing Ryan White care to the people who need it most.

Family Health Centers of San Diego, San Diego, CA

The six-month recertification policy to assess Ryan White eligibility is extremely burdensome and should be changed, however, currently in California ADAP clients must also recertify every six months so in our case removing the Ryan White requirement will not significantly reduce the workload, unless the ADAP requirement went back to annual as well.

Grady Health System Infectious Disease Program, Atlanta, GA

The eligibility screen can definitely create barriers to care and service delivery. It can also feel unnecessary and burdensome to clients whose income rarely, if ever, changes. (Many are on public benefits that do not change or their incomes are so far below most jurisdictions’ eligibility criteria that it would be nearly impossible for their income to change enough to be ineligible.) The HAB requirement should be changed to an annual eligibility determination only (removing the 6-month certification of changes or no changes). The process for all Ryan White parts should be consistent so there is no difference in timeframes for clients receiving Ryan White A support from those on ADAP (Ryan White B). This change would help simplify the process for clients and streamline the process for providers.

Hawaii Department of Health, Honolulu, HI

Regarding RFI Section C.3., the operator of its electronic data collection system had also been previously made aware of this proposed change. The electronic data collection system operator has determined that the impact of this change on the data collection system and on operations will be minor.

Harborview Medical Center, Seattle, WA

The six-month recertification process has little utility. Of the 3,000 patients my clinic serves who have HIV, I have no examples of clients who had a change in income or residency such that they are now no longer eligible for Ryan White services within six months of the last certification in the last 9 years I have been working at this clinic.

However, the process of collecting the verifications (which ultimately show the client is still eligible) are a tremendous administrative burden to both the client (who is asked by every Ryan White service provider for the same verifications twice a year) and the agencies collecting them. Whole positions are dedicated to collecting & managing the verifications, which is a waste of staff time and of clinic resources. I am hopeful that you will examine the need for the six month recertification, and decide that it is indeed a waste of resources and time.

HIV Medicine Association (HIVMA), Arlington, VA

Regarding the annual eligibility screening and six-month recertification of eligibility for Ryan White Program clients, like HRSA/HAB, HIVMA and RWMPC also have witnessed that the requirements have been difficult and sometimes burdensome for patients receiving Ryan White Program services to meet and for clinics to administer. Many patients receiving Ryan White Program services do not experience income or healthcare coverage changes significant enough to disqualify them from Ryan White Program services within such a short, six-month time period. Additionally, many patients have limited personal, social, and/or financial resources to complete this process so frequently. These processes and requirements create barriers to patients engaging in HIV care and treatment and result in delays or interruptions in HIV treatment access that make it difficult for patients to achieve or maintain viral suppression. These policies can compromise patient outcomes by leading to disruptions in HIV treatment or other related care or treatment that jeopardize individual patient health and increases HIV transmission risk. While we strongly urge HRSA/HAB to incentivize the implementation of streamlined eligibility and recertification processes by Ryan White grantees, including the AIDS Drug Assistance Program, we urge HRSA/HAB to do away with the recertification process every six months and instead move to an annual recertification process if possible. Additionally, for whatever eligibility and recertification process is in place, HRSA/HAB should track and monitor Ryan White Program eligibility disruptions related to these processes.

The HRSA/HAB Policy Clarification Notice (PCN) #13-02 outlines for grantees the flexibility provided to develop streamlined certification and recertification processes. In addition, the National Alliance of State and Territorial AIDS Directors (NASTAD) has developed resources to help clarify for grantees requirements for the Ryan White Program annual eligibility and recertification process and to highlight best practices1. However, clinicians working in Ryan White-funded clinics report that real-world implementation problems persist. HIVMA and RWMPC make the following recommendations for remediating some of these issues, including:

  1. Identify solutions that reduce the administrative burden on patients as a way to remove barriers to HIV care and treatment. Locating documents required for recertification is still difficult for some patients. At any given time during the process, many patients are either homeless or not living in their own dwelling, making it extremely difficult to contact them or mail them documents, despite the fact that patients may now sign documents electronically. Additionally, many patients living in rural communities do not have access to public transportation and therefore are unable to return to clinic to present necessary paperwork in a timely fashion. As highlighted by NASTAD, patient attestation by phone or email (as well as in person) of no changes in financial or insurance status is permissible as well as allowing clients to either sign attestation or provide documentation of changes at the next clinic or service visit. However, not all states have implemented this streamlined approach, and it still is common for some patients to fail to renew their certification or miss clinic appointments because they lack the required documents or fail to attest. Unfortunately, this problem results in the disruption of critical HIV care and treatment.
    HIVMA and RWMPC urge HRSA/HAB to continue to find solutions that reduce administrative burden on patients as a way to remove barriers to HIV care and treatment. For example, self-attestation, while an important improvement, may not be needed from the patient if the case manager has recently documented this information in the patient’s file or chart. Therefore, case managers should be permitted to attest that there are no changes in patient status in order to facilitate timely completion of the Ryan White Program eligibility and recertification process.
  2. Clarify for Ryan White grantees the flexibility to use either household income or individual income when assessing program eligibility or recertification and provide training and technical assistance to grantees on when it is best to use each income standard. Ryan White Program legislation requires that individuals receiving services must have a diagnosis of HIV/AIDS and be low-income as defined by the grantee. HAB PCN 13-02, "Clarifications on Ryan White Program Client Eligibility Determinations and Recertification Requirements," clarifies the requirement that all Ryan White Program grantees establish and monitor procedures to ensure that all funded providers verify and document client eligibility. Additionally, HAB PCN 13-03, “Ryan White HIV/AIDS Program Client Eligibility Determinations: Considerations Post-Implementation of the Affordable Care Act,” encourages recipients to consider aligning their Ryan White Program financial eligibility requirements with Modified Adjusted Gross Income (MAGI)-based methodologies to reduce the burden on clients and to support coordination with the eligibility determination processes for insurance programs, such as Medicaid and CHIP. As MAGI is the total of a household's adjusted gross income plus any tax-exempt interest income, Ryan White Program grantees that utilize MAGI for initial eligibility and recertification determinations do so based on household income. While HIVMA and RWMPC support streamlining and aligning the eligibility processes for the Ryan White Program and insurance and/or health care programs as a way to reduce administrative burden on both patients and grantees, it is important to note that requiring patients to provide proof of income for relatives or individuals with whom they reside to calculate household income can be problematic in some cases. Stigma and other considerations sometimes prevent patients from disclosing their HIV infection to others in their household. Gathering proof of household income in some of these cases could force a confidentiality breach of a patient’s HIV status that would jeopardize their safety and/or well-being. In such instances, Ryan White Program grantees should have the flexibility to consider the patient’s individual income when assessing Ryan White Program eligibility or recertification, especially since using household income for this determination is not required by statute. Some Ryan White Program grantees already use individual income as the way to assess Ryan White Program eligibility.
  3. Permit retroactive payment for services by the Ryan White Program when there have been patient Ryan White Program eligibility gaps as a way to improve the financial support available to provide ready access to HIV care and treatment. While recertifying all patients in a timely way can be challenging, preventing treatment interruptions for all patients is critical. Clients may not receive services if their eligibility period (six months) has expired and they have not recertified. The Ryan White Program does not permit a grace period for missed annual eligibility or recertification determinations. While many Ryan White clinics and providers allow for sufficient time for recertification, some patients will have trouble meeting deadlines for a variety of reasons. The availability of alternate funding to cover patient costs during these eligibility gaps is difficult for some clinics to identify or they may not exist at all, especially when Ryan White Program funding has remained level funded for the past several years. Allowing Ryan White grantees to pay for services with the Ryan White Program retroactively, upon a patient’s recertification, would help to ease this administrative and financial burden on both the clinics and patients. Such a policy could be very similar to the Medicaid Program policy that permits medical providers to bill Medicaid for care provided to a patient during the previous three months prior to Medicaid eligibility. This type of approach would help ensure more seamless access to HIV care and treatment and uninterrupted anti-retroviral therapy, thus improving both individual and public health outcomes by better supporting patient viral suppression.

Finally, HRSA/HAB should monitor states and localities to ensure that they do not require additional items for Ryan White Program eligibility and recertification determinations that make the process more difficult, expensive, or time consuming for patients to complete and for clinics and other Ryan White Program grantees to administer.


1 NASTAD. Ryan White Eligibility Determination and Recertification: Improving Efficiency. January 2017. Online at: https://careacttarget.org/sites/default/files/file-upload/resources/NASTAD-eligibility-recertification-january-2017.pdf. HRSA Exit Disclaimer

HIV Services Planning Council | Multnomah County, Portland, OR

The Portland, OR TGA solicited comments from Ryan White sub-recipients regarding documentation of eligibility every six months. As a collective system of care, we have found no benefit in documenting eligibility every six months. Collecting eligibility every six months opposed to annually is a burden to both service providers and clients for the following reasons:

  • Tracking down the required documents to verify eligibility is a challenge. Service providers spend countless hours creating systems to monitor who is due for an eligibility review and what documents are missing. Clients often do not come to appointments with all required documents. This means that service providers are responsible for following up with clients until all the correct documents are received. Service providers have reported spending weeks of concerned efforts trying to track down documents from clients. Service providers are putting more resources towards verifying eligibility that could be more beneficial towards engaging people in services.
  • Clients cannot easily get access to documents in a timely manner, which could create delays in services. A delay in service could mean the difference of someone returning to care in the future.
  • Additionally, clients have other complicating factors that make gathering documents a challenge. Factors could include being homeless and not having anywhere safe and dry to store documents, literacy challenges, being released from jail or prison in which papers are not readily available, and cognitive problems that may impact remembering where or how to access documents.
  • Clients, especially those with mental health diagnosis, have expressed frustration, anxiety and paranoia with needing to provide the same documents over and over again in order to access service and assistance programs. In some cases this has created unnecessary fear for clients that are concerned they will lose benefits if they cannot quickly produce eligibility documents.
  • Clients' situations do not change that often. Specifically place of residence, insurance, and income are not changing enough to make someone ineligible for Ryan White services.
  • Ryan White is the only federal program that requires documentation every six months. Many service providers are also conducting recertifications for other federal assistance programs such as HOPWA, Shelter Plus Care, Medicaid, open enrollment, etc. on an annual basis. Aligning Ryan White certifications with the requirements of other federal programs would ease the burden.

The goals of Ryan White programs are to increase access to care and improve health outcomes. Collecting eligibility documents every six months creates systematic barriers to achieving this goal. It puts an excessive burden on people living with HIV which does not exist for other federal programs. As a result of this requirement, we have had to devote more funding to collection of eligibility documents which takes away from funding that should go towards services. Thank you for reviewing these comments.

Holmwood Data Consulting, Ridgewood, NJ

The 6 month recertification has posed challenges for MCMs and PLWH because of the amount of documentation required to bring for review and getting the consumer to comply can require time-consuming staff follow-up. Many of our RW consumers have been in care with our medical programs for 20 years or more and their income and insurance benefits are in place and change in RW eligibility is unlikely; similarly any PLWH eligible for and receiving ADDP is also RW eligible so conducting another eligibility screen every 6 months is duplicative. Also, as many PLWH are stable and VLS the interval between scheduled visits is longer so e.g. if a PLWH is seen every 6 months and an appointment is missed around the time of the 6 month recertification the program is out of RW compliance (6 Months Eligibility Determination is a Condition of Award).

This does not happen in our TGA but we are aware of RW programs in our region that notify the client that their case is closed if a 6 month recertification visit is missed, then when (if) the PLWH returns the case is reopened which is counterproductive to retention in care and disruptive to the consumer.

Iowa Department of Public Health, Des Moines, IA

  1. Regarding the reasonableness of the content and amount of documentation required for the 75/25, we believe that it is too extensive. In a state that has expanded Medicaid as well as have 90% of ADAP clients on insurance, it seems quite obvious that the core medical needs are being largely met outside of the Ryan White Part B grant. In addition, in a state that is collecting significant rebate funding, it should be allowed to use Part B funds to address other issues that are keeping so many PLWH out of care. Things like housing, emergency financial assistance. In addition, flexibility to use more funding on support services ensures appropriate level of services are provided to those who are doing well, but need to stay connected with the system to ensure long-term engagement. It is well documented in several places how it is critical these services are.
  2. We believe that collecting client level data regardless of which funding stream is used is not only acceptable, but important to best show how critical our services and our programs are in ending the epidemic.
  3. We believe that 6-month recertification is a reasonable requirement for service categories such as ADAP and Medical Case Management services. However, we do not believe that 6- month recertification is necessary for all service categories. There should be a mechanism to document justification for not collecting that information. Examples include psycho social support services and outreach.

IU Health Methodist Hospital, Indianapolis, IN

The six month recertification is absolutely a burden on care providers and services as a barrier to care for eligible clients as well. It leads to more gaps in coverage as well as a tremendous amount of non-medical case management hours to work.

Keystone Health HIV Program, Chambersburg, PA

While I understand the intention of ensuring that Ryan White funds are being used for the intended recipients, in my 14 years of working in a Ryan White program I can only remember one instance of someone receiving RW funded services that did not qualify. That is because as an integral part of our work flow we make sure those seeking services meet eligibility requirements. The process of collecting and submitting documents biannually to prove that eligibility and tracking the certifications is an unnecessary waste of time and resources that can be much better spent on providing services to clients. For most Ryan White providers, the majority of the population we serve inherently qualifies for Ryan White services and the elements of income, residence, insurance change very little over the course of time. When they do change, assessing continued eligibility is a part of our process. The resources wasted on verifying eligibility of the 95+% whose eligibility never changes is obscene when funds to provide actual services is so limited. It makes much more sense to review the grantee or provider's process for qualifying clients' eligibility for Ryan White services as part of a site visit, the same as compliance with other Ryan White standards and legislative requirements.

Legacy Community Health, Houston, TX

Legacy appreciates HRSA’s request for input regarding the burden of the six-month recertification policy to assess RWHAP client eligibility for services. Lessening the burden of requiring six-month recertifications for all Ryan White patients would eliminate the need for significant staff resources required to perform them, and would ease the burden on patients that have minor changes in income or healthcare coverage and still qualify for the program. We recommend HRSA allow patient self-attestation to notify providers of minor changes in income or healthcare coverage, and encourage the removal of the six-month recertification process when minor changes do not disqualify patients from the program.

Legacy Counseling Center, Dallas, TX

While we understand that information needs to be updated on a 6 month basis, the new policy of doing this on birthdays and half birthdays is excessive and unnecessarily administratively burdensome.

We have been updating all clients in January and in June. This provision ensures that no client will go more than 6 months without being updated.

Trying to figure out birthdays and half birthdays and scheduling updates is:

  • Difficult to track
  • Confusing to clients
  • Time consuming

We already have a burdensome amount of paperwork and things to track, adding this random unnecessary step has created chaos and reduced our ability to service additional clients because we have to be mindful of the ½ birthday additional burden we must now track.

Our prior system, updating all people in January and June served the same purpose of ensuring eligibility but did not require us to spend time daily seeing if there is a ½ birthday and making client come in to update information.

Our client financial and health insurance status does not tend to jump in and out of eligibility in first place. Adding this extraneous step is limiting our ability to do our jobs and discouraging clients to stay in care. They are tired of coming to the 5 agencies where they get services 2 extra times a year to update information. This is creating an unnecessary administrative burden on them which decreases the chances they will stay in care. It’s just too much trouble.

Maricopa Integrated Health System, Phoenix, AZ

 

The Maricopa County Special Health Care District dba Maricopa Integrated Health System (MIHS) submits the following comments in response to the Request for Information (RFI) issued by the Health Resources and Services Administration (HRSA) in May 2018. MIHS is pleased to continue our long collaboration with HRSA. The comments address Section C.3 of the RFI regarding Ryan White HIV/AIDS Program (RWHAP) client eligibility determinations and recertification requirements.

MIHS has been involved with RWHAP since 1990, when we received HRSA Demonstration Project funding to open our McDowell Health Care Center (MHCC), now the largest HIV primary care medical practice in Arizona. We are the oldest Ryan White recipient in the state and receive funding under RWHAP Parts A (sub-recipient), B (rebate funding sub-recipient), C (recipient), and D (recipient).

For over twenty-five years, MHCC has provided exceptional state-of-the-art primary HIV care and wrap-around services for Persons Living with HIV (PLWH). MHCC offers primary HIV medical care, oral health care, outpatient behavioral health, laboratory testing, and integrated supportive services, including medical case management. Because of the excellent reputation of MHCC in the state, and the lack of providers in rural areas, one in every five PLWH in Arizona chooses MIHS for all or part of their HIV care. As the largest provider of primary HIV care services in Arizona, one in every three PLWH in Maricopa County chooses MHCC for all or part of their health care. The majority of PLWH seeking care at MHCC are underserved and medically needy. MHCC is home to the only HIV Women's Clinic in Arizona and is located in a Medically Underserved Area and Health Professional Shortage Area. The exceptional care provided to PLWH was noted by HAB during a DCHAP site visit in 2015. The site visit team wrote, "Overall, the majority of the clients expressed extreme satisfaction with medical care, their relationship with providers/staff and the aesthetic of the current clinic site."

MHCC provides services to a diverse community. Our target populations include those who are racially and ethnically diverse — particularly Hispanics and Blacks or African Americans. Other target populations include gay, bisexual, and other men who have sex with men, women, pregnant women, youth transitioning into adult care, transgender persons, post-incarcerated persons, and those who are unstably housed.

RWHAP Policy Clarification Notice (PCN) 13-02, Clarifications on Ryan White Program Client Eligibility Determinations and Recertifications Requirements, re-enforces the long-standing policy of the HIV/AIDS Bureau (HAB) requiring eligibility reviews at least every six months for PLWH seeking RWHAP funded services.1 Consistent with changes to the Medicaid program accomplished under the Affordable Care Act (ACA), MIHS strongly urges HRSA to reconsider this policy by moving to annual eligibility reviews.

The purpose of the Ryan White HIV/AIDS Program (RWHAP) is to provide comprehensive primary health care and support services in an outpatient setting for low income, uninsured, and underinsured People Living with HIV (PLWH).2 Our recommendation is based on an extensive review of the published literature regarding six month versus annual eligibility certifications in both Medicaid and Children's Health Insurance Program (CHIP) populations. Because of the demographic similarities in these populations, we think the study findings apply across both the Medicaid and the RWHAP programs. There is little, if any, published research concerning RWHAP program enrollment time frames. In our analyses, RWHAP coverage, which is not insurance, is analogous to Medicaid coverage.

WHAT IS CHURN?

The major concept related to enrollment periods is that of Churn. "Churning" occurs when individuals lose coverage and then regain it after only a short period of time — often because of unnecessary burdens in the eligibility renewal process.3 Churn can also be defined as unstable insurance coverage,4 discontinuous coverage, or gaps in coverage.5 Medicaid churning — the constant exit and re-entry of beneficiaries as their eligibility changes — has long been a problem for both Medicaid administrators and recipients.6 Churning undermines continuity of care.7

In 2009, MIHS completed a review of our then existing RWHAP enrollment process. Using a Plan-Do-Study-Act (PDSA) cycle, we identified efficiencies that increased retention and reduced churn. Our baseline PDSA data included 749 patients over a sixteen-month period starting in January 2007. Because of six-month recertification requirements, there were a total of 1,281 renewal opportunities (an average of 1.7 renewals per patient) during the sixteen-month period.

The goal of the PDSA cycle was to increase timely RWHAP renewals while easing the burden on patients and administrative staff. The initial range of renewals started at 36 days early to 486 days late. The average renewal occurred 65 days late while the median renewal occurred 10 days late. Of the 1,281 renewals included in the PDSA, only 34% (439) were completed timely.

The goal of the PDSA was to eliminate HIV primary medical care churning by streamlining the renewals process. This goal reduced the chance that patients may incur charges while also reducing administrative burden. Simultaneously, the goal increased access to and retention in HIV primary medical care, improved patient and provider satisfaction, and promoted business efficiency. The ultimate goal for everything that we do is better patient health outcomes.

The streamlining undertaken included more targeted reminder mailing, inclusion of postage-paid return envelopes, and the elimination of an in-person office visit to complete the renewal. At the start of the PDSA, 13% (74 of 554 patients) were overdue for their six-month renewal. At the end of the PDSA, the overdue percentage had shrunk by 33% in that 52 of 581 patients (9%) were overdue.

Administrative simplification reduces churn. Administrative simplification can, and should, include annual renewal. Administrative simplification leads to better health, better care, and reduced cost.

WHO EXPERIENCES CHURN?

In calendar year 2016, on a national level, 62.8% of RWHAP clients lived at or below 100% of the federal poverty level (FPL). Three-quarters (74.8%) of RWHAP clients lived at or below 138% FPL (the income limit for states with expanded Medicaid).8 Lower income is the single factor most related to churning.

Churning is experienced disproportionately by patients with lower incomes, especially those below 200% FPL. Other factors that increase the likelihood of churn include younger age,Hispanic ethnicity, and those with lower educational levels. Despite all other factors and across all racial and ethnic groups, the rate of stable insurance enrollment was lower among those with incomes below 200% of FPL.4-5,7,9-10

Any experience with low income (family income below 200% FPL) results in higher rates of unstable insurance coverage. Individuals and families always below 200% FPL were disproportionately subject to instable insurance coverage.4 In low income families with children, the greatest predictor of a child’s gap in insurance coverage is having one or more parents without continuous (or any) coverage. This is true even if the child remains eligible for insurance coverage.5

Having parents without continuous coverage was the greatest predictor of a child's coverage gap in both 1998 and 2009. Compared to children with at least one parent continuously covered, children whose parents did not have continuous coverage had a significantly higher relative risk of a coverage gap. In adjusted models, parental continuous coverage was the only significant predictor of discontinuous coverage for children.5

Lower family and individual incomes increases churn and discontinuous insurance coverage.

WHAT ARE THE CONSEQUENCES OF CHURN?

Churning negatively effects the overall quality of medical care and health outcomes.11 Access to health insurance coverage has important effects on clinical outcomes for PLWH. Not having health care coverage can delay HIV diagnosis and linkage to HIV care. Once in care, PLWH without continuous health care coverage are more likely to discontinue anti-HIV medications, which leads to unsuppressed viral load.12

The updated National HIV/AIDS Strategy for the United States (NHAS) calls for the proportion of diagnosed PLWH who are virally suppressed to increase to at least 80% by 2020.13 HAB reports that, in 2016, 85% of RWHAP enrolled clients had achieved viral suppression.14 While this is an impressive achievement and exceeds the NHAS goal, it does not tell the full story.

In calendar year 2016, 21% of RWHAP enrolled clients had no health insurance coverage.8 When viral suppression data are stratified by health care coverage categories, health disparities emerge. For example, RWHAP clients who have health insurance provided by an employer achieved 91% viral suppression. Those enrolled in Medicaid achieved 81% viral suppression. RWHAP clients with no health insurance coverage achieved only 79% viral suppression.14

Viral suppression is generally achieved only when PLWH have access to a provider with privileges to prescribe anti-retroviral therapy (ART). Once prescribed, PLWH must actually take the medications as prescribed. Skipping medications was twice as common among those with coverage gaps than among those without gaps. Churning also leads to changes in prescription medications.11

As demonstrated by the HAB viral suppression data, churn is problematic because insurance discontinuities are associated with higher rates of unmet medical and prescription drug needs. Churn contributes to a lack of recommended preventive health services similar to the uninsured. All these factors lead to poorer health. In comparison, having continuous health insurance leads to better access to health care and improved health outcomes.5

In addition to ART interruptions, insurance coverage disruption may cause adults to forgo routine care. Interruptions in Medicaid coverage are associated with lower rates of primary and preventative care services. Patients with churning Medicaid status have office-based visits at a rate 75% lower than those with stable insurance.10 Gaps in insurance coverage impinge on continuity of care, especially primary care, which affects care quality and health outcomes.15 Policies that result in churning mean that many vulnerable patients fall outside of accountability structures intended to assure they receive necessary services.16

Continuity of care, including reduced client and administrative burden, show significant gains in terms of insurance coverage, affordability of care, access to preventive care, and chronic disease management. Perhaps most important, were improvements in the perceived quality of care and overall health status.17 Continuity of coverage is associated with more accessible and higher quality healthcare, both of which are fundamental aims of the ACA.18 In addition to improved access to care and utilization there are increases in the diagnoses of a range of diseases and conditions and in the number of adults receiving consistent care for chronic conditions like HIV.19

Churning also contributes to increased Medicaid expenditures for medical care. People who experience lapses in coverage often re-enroll in Medicaid when, for example, they obtain high-cost care in hospitals that could have been avoided with better ongoing care. Research also has shown that people with short episodes of coverage have poorer quality of health care than people enrolled for longer episodes. In short, costs to taxpayers and to eligible individuals would be substantially lower if Medicaid churning were reduced.6

The consequences of churn and gaps in care result in poorer health outcomes, decreased patient satisfaction, and greater disease burden. Stable coverage leads to better health, better care, and reduced cost.

HOW CAN CHURN BE REDUCED?

The peer-reviewed literature shows us that frequent and burdensome Medicaid renewal processes exacerbate churn, resulting in breaks in enrollment and the need to reenroll.19 We also know, as a practical matter, nothing can completely eliminate churn.18

That said, the Ryan White HIV/AIDS Program can and should revise existing policies and institute new policies to reduce churn. Researchers and policy analysts have proposed strategies to mitigate the disruptive effect of churning on ambulatory care use. First and foremost is the provision of twelve months of guaranteed eligibility.5-6,9-10,15,18,20-24

Adults could be granted [RWHAP] enrollment for twelve months from the date of their initial or annual eligibility determination and would retain eligibility for twelve months, with some exceptions, even if a change in income or life-circumstances would otherwise make them ineligible. By guaranteeing coverage for twelve months after a person’s initial and subsequent eligibility redeterminations, churning is eliminated for that client for a year.6

There may also be times when a lack of client understanding contributes to churn. Not understanding a need to submit documentation or sign something can deter individuals from recertifying in a timely manner.19 Continuous eligibility promotes retention and reduces churn — that is, individuals moving on and off coverage due to small income changes, which can be administratively costly and result in gaps in health care access. Many quality measures require at least twelve months of continuous enrollment, so the policy shift also enhances the abilities of RWHAP providers to assess quality of care.22

The twelve month eligibility option involves procedures that could simplify [RWHAP] eligibility recertification and avoid disruptions in coverage commonly caused by income fluctuations, administrative errors, and enrollees’ not fulfilling re-certification requirements.6 The enrollment and reenrollment of the same eligible clients introduces inefficiencies and unnecessary administrative costs into public programs without increasing program participation rates.24 Twelve month enrollment increases administrative efficiency and accuracy, which are important benefits for programs dealing with reduced financial resources to manage their programs.23

Twelve-month enrollment reduces churn. The reduction provides better health, better care, and reduces cost and administrative burden.

DISCUSSION

HIV/AIDS Bureau (HAB) PCN 13-02 states that to "maintain eligibility for RWHAP services, clients must be recertified at least every six months." HAB sites both the 2011 National Monitoring Standards (NMS) and the statutory requirement that RWHAP funds are utilized as the payer of last resort.1

NATIONAL MONITORING STANDARDS

The NMS for Parts A and B include language requiring six-month recertification.25-26 The requirements include source citations, specifically to Title XXVI of the Public Health Service (PHS) Act (codified at 42 U.S.C. § 300ff-11 et seq). For the Ryan White Part A NMS, the sources cited for rationalization of six-month eligibility are PHS Act §§ 2604(c)(3)(B) and 2616(e).25 For the Ryan White Part B NMS, the sources cited for rationalization of six-month eligibility are PHS Act §§ 2612(b)(3)(B) and 2616.26

The plain language contained in the statute cited in the NMS defines an eligible individual as having a medical diagnosis of HIV/AIDS and being low-income as defined by the individual state (see PHS Act § 2616(b)).27

The statutory language does not specify how often eligible individuals must recertify their eligibility.

Thus, the language included in both the National Monitoring Standards and in PCN 13-02 are policy requirements promulgated by the HIV/AIDS Bureau and not statutory requirements promulgated by Congress. Policy requirements can, and should, be revisited and revised from time to time to ensure their continued relevance to further program goals.

In light of the statutory silence regarding recertification requirements, MIHS urges HAB to revise current policy to implement twelve-month recertifications requirements.

PAYER OF LAST RESORT

The PHS Act §§ 2605(a)(6), 2617(b)(7)(F), 2664(f)(1), and 2671(i) are collectively referred to as the Ryan White payer of last resort requirement. By statute, RWHAP funds may not be used for any item or service "for which payment has been made or can reasonably be expected to be made" by another payment source.1 This requirement is most germane when RWHAP funded entities provide medical, behavioral, and oral health care or other services funded by third-party payers.

In order to provide RWHAP funded services, entities eligible to bill third-party payers must have participation agreements with those payers. Every RWHAP application, renewal, and conditions of award require recipients and subrecipients to provide Medicare and Medicaid numbers for licensed clinical staff eligible to bill those programs for provided services.2 Additionally, the majority of RWHAP funded medical providers have attained HRSA designation as a Federally Qualified Health Center (FQHC) or as an FQHC-Look-Alike (FQHC-LAL). HRSA's Health Center Compliance Manual also requires both FQHCs and FQHC-LALs to participate in and bill services to third-party payers.28

Best practices under both the RWHAP and Health Center programs dictate that at every clinical visit, the insurance status for each patient presenting for services should be verified.

Because providers are required by one or more programs to check for public or private health insurance coverage at every visit, the payer of last resort provisions in the RWHAP legislation are fulfilled more frequently than every six months, depending on the patient’s health status and visit frequency. Even if an RWHAP client is enrolled for twelve months of continuous services, if the client becomes eligible for Medicaid or other insurance coverage, that insurance status will be discovered, either by routine checks of electronic databases or by client disclosure.

Eligibility for services not billable to third parties (e.g., medical case management or patient navigation) should not be jeopardized every six months when the payer of last resort provisions are not applicable.

Twelve-month recertification does not compromise payer of last resort requirements. MIHS urges HAB to revise current policy to implement twelve-month recertifications requirements.

REFERENCES

  1. Health Resources and Services Administration, HIV/AIDS Bureau. Policy Clarification Notice #13-02: Clarifications on Ryan White Program Client Eligibility Determinations and Recertifications Requirements.
  2. Health Resources and Services Administration, HIV/AIDS Bureau. Ryan White HIV/AIDS Program Part C HIV Early Intervention Services Program: Existing Geographic Services Areas. Notice of Funding Opportunity Number HRSA-18-001. June 2017.
  3. Redmond, P. Medicaid and SCHIP Retention in Challenging Times: Strategies from Managed Care Organizations. Center on Budget and Policy Priorities. September 2005.
  4. Klein K, Glied S, and Ferry D. Entrances and Exits: Health Insurance Churning, 1998-2000. The Commonwealth Fund, Issue Brief #855. September 2005.
  5. DeVoe JE, Tillotson CJ, Angier H, and Wallace LS. "Predictors of Children's Health Insurance Coverage Discontinuity in 1998 Versus 2009: Parental Coverage Continuity Plays a Major Role." Maternal and Child Health Journal, Vol. 19, No. 4. April 2015.
  6. Swartz K, Short PF, Graefe DR, and Uberoi N. "Evaluating State Options for Reducing Medicaid Churn." Health Affairs, Vol. 37, No. 7. July 2015.
  7. Ravel G and DeSantis A. "Crossing 138: Two Approaches to Churn under the Affordable Care Act." Health Matrix: Journal of Law-Medicine, Vol. 24. 2014.
  8. Health Resources and Services Administration, HIV/AIDS Bureau. Clients Served by the Ryan White HIV/AIDS Program, 2016 – Overview. December 2017.
  9. Dickson V. "The Challenge of Churning: Insurers and States Seek to Ensure Coverage Continuity between Medicaid and Private Plans." Modern Healthcare, Vol. 44, No. 30. July 2014.
  10. Roberts ET and Pollack CE. "Does Churning in Medicaid Affect Health Care Use?" Medical Care, Vol. 54, No 5. May 2016.
  11. Sommers BD, Gourevitch R, Maylone B, et al. "Insurance Churning Rates for Low-Income Adults under Health Reform: Lower than Expected but Still Harmful for Many." Health Affairs, Vol. 35, No. 10. October 2016.
  12. Monroe AK, Myint L, Rustein RM, et al. "Factors Associated with Gaps in Medicaid Enrollment among People with HIV and the Effect of Gaps on Viral Suppression." Journal of Acquired Immune Deficiency Syndromes, Vol. 78, No. 4. August 2018.
  13. The White House, Office of National AIDS Policy. The National HIV/AIDS Strategy for the United States: Updated to 2020. July 2015.
  14. Health Resources and Services Administration, HIV/AIDS Bureau. Clients Served by the Ryan White HIV/AIDS Program, 2016 – HIV Care Outcomes: Viral Suppression. December 2017.
  15. Rosenbaum S, Lopez N, Dorley M, et al. Mitigating the Effects of Churning under the Affordable Care Act: Lessons from Medicaid. The Commonwealth Fund. June 2014.
  16. Fairbrother G, Jain A, Park HL, et al. "Churning in Medicaid Managed Care and Its Effects on Accountability." Journal of Health Care for the Poor and Underserved, Vol. 15. 2004.
  17. Maylone B and Sommers BD. Evidence from the Private Option: The Arkansas Experience. The Commonwealth Fund, Issue Brief 1932. February 2017.
  18. Rosenbaum S. "Addressing Medicaid/Marketplace Churn through Multimarket Plans: Assessing the Current State of Play." Journal of Health Politics, Policy and Law, Vol. 40, No. 1. February 2015.
  19. Fairbrother G, Park HL, Haidery A, and Gray BH. "Periods of Unmanaged Care in Medicaid Managed Care." Journal of Health Care for the Poor and Underserved, Vol. 16. 2005.
  20. Antonisse L, Garfield R, Rudowitz R, and Artiga S. The Effects of Medicaid Expansion under the ACA: Updated Findings from a Literature Review. The Henry J. Kaiser Family Foundation. March 2018.
  21. Saunders MR and Alexander GC. "Turning and Churning: Loss of Health Insurance among Adults in Medicaid." Journal of General Internal Medicine, Vol. 24, No. 1. December 2008.
  22. Sommers BD, Graves JA, Swartz K, and Rosenbaum S. "Medicaid and Marketplace Eligibility Changes Will Occur Often in All States; Policy Options Can Ease Impact." Health Affairs, Vol. 33, No. 4. April 2014.
  23. Brooks T, Wagnerman K, Artiga S, and Cornachione E. Medicaid and CHIP Eligibility, Enrollment, Renewal, and Cost Sharing Policies as of January 2018: Findings from a 50-State Survey. The Henry J. Kaiser Family Foundation. March 2018.
  24. Heberlein M, Brooks T, Guyer J, et al. Holding Steady, Looking Ahead: Annual Findings of a 50-State Survey of Eligibility Rules, Enrollment and Renewal Procedures, and Cost Sharing Practices in Medicaid and CHIP, 2010-2011. The Henry J. Kaiser Family Foundation, Kaiser Commission on Medicaid and the Uninsured. January 2011.
  25. Orzol SM, Hula L, and Harrington M. "Program Churning and Transfers between Medicaid and CHIP." Academic Pediatrics, Vol. 15, No. 3S. May-June 2015.
  26. Health Resources and Services Administration, HIV/AIDS Bureau. National Monitoring Standards for Ryan White Part A Grantees. April 2013.
  27. Health Resources and Services Administration, HIV/AIDS Bureau. National Monitoring Standards for Ryan White Part B Grantees. April 2013.
  28. Public Health Service Act, as Amended through Public Law 114-113. Enacted December 18, 2015.
  29. Health Resources and Services Administration, Bureau of Primary Health Care. Health Center Program Compliance Manual. January 2018.

Massachusetts Department of Public Health, Boston, MA

Six-Month Recertification of Eligibility — While recertification can be burdensome in some cases, it also enables the accessing of services by those most in need. HRSA has already instituted the approved option to use client attestation as an abbreviated process when needed. Massachusetts has seen no evidence that the six-month recertification of eligibility has impacted patients' access to medical services, retention in care, access to HIV antiretroviral medications, and ultimately reaching viral suppression.

Medical Advocacy and Outreach (MAO), Montgomery, AL

Medical Advocacy and Outreach (MAO) is responding to the Request for Information (RFI), Section C.3 regarding HRSA's HIV/AIDS Bureau (HAB) policy requiring the completion of annual eligibility screening and six-month recertification for clients receiving Ryan White HIV/AIDS Program (RWHAP) Part B services.

MAO is a community-based organization providing medical and social services to persons living with HIV/AIDS (PLWHA) in Alabama. MAO maintains three (3) full-time clinic locations, as well as ten (10) outreach clinics serving 28 rural counties in South Central Alabama. MAO provided care to over 1,800 PLWHA in 2017.

MAO respectfully requests consideration for the removal of the six-month eligibility recertification currently required for PLWHA receiving RWHAP Part B services. The six-month recertification process is burdensome and creates additional barriers for an already marginalized and vulnerable population. Other federally-funded programs, including those aimed at providing access to medical care (i.e. Medicaid, CHIP, etc.) require eligibility screening on an annual basis. Imposing additional eligibility requirements for PLWHA inhibits progress towards the eradication of HIV/AIDS; further oppresses and stigmatizes PLWHA; and negatively impacts already limited access to medical care.

In 2017, over half of MAO's consumers received a RWHAP Part B-funded service which includes approximately 500 clients enrolled in medication assistance through AIDS Drug Assistance Program (ADAP) and/or the Alabama Insurance Assistance Program (AIAP). For PLWHA, these programs offer much needed access to medical care and antiretroviral therapy (ART) in order to achieve and maintain viral suppression, thereby reducing the risk of HIV transmission to others. While a large portion of MAO's clients completed initial and/or annual enrollment for RWHAP services in 2017, nearly 25% of clients subsequently lost access to these services due to failure to complete the six-month recertification. The majority of these clients did not experience income or healthcare-coverage changes that would impact their eligibility to receive RWHAP services; they simply did not recertify. This results in a loss of medication and/or insurance coverage that is crucial to supporting viral suppression.

As previously stated, PLWHA are a vulnerable population and face significant barriers by simply living in the rural South. Many are transient, lack support from their family and/or community, and experience other disparities in addition to HIV infection; however, removing the additional requirement of a six-month recertification for RWHAP Part B services will allow PLWHA continued access to medical care and supportive services, and promote better health outcomes to one day see an end to the HIV epidemic.

MAO is grateful for the opportunity to provide information to streamline administrative procedures and reduce burdens associated with the provision of healthcare services to disadvantaged populations and anxiously awaits a favorable response.

Mendocino Community Health Clinic (MCHC), Ukiah, CA

The six-month recertification policy to assess Ryan White eligibility is extremely burdensome and should be changed. As California has fully implemented health care reform, Ryan White consumers do not experience significant shifts in health care coverage due to minor fluctuations in income. Further, as the vast majority of Ryan White consumers have other health and mental health issues, it has been increasingly difficult to get consumers to recertify through the mail or in-person. While we have tried to make the six-month recertification as easy as possible, it increases time and resources spent by enrollment workers and is a barrier to patients.

In response, MCHC requests that recertification be simplified to include a standard question asking if there are any changes to the patient's eligibility, which will be asked at each encounter, instead of a periodic redetermination process. This would require less paperwork and time spent recertifying by enrollees and health center staff.

If we cannot move to a periodic recertification attestation at each encounter, we ask that HRSA move to an annual certification. Returning to annual recertification would decrease the burden on enrollment workers and consumers. It would also align Ryan White recertification with Covered CA (California's health exchange) and Medi-Cal.

NASTAD, Washington, DC

PLWH receiving RWHAP and ADAP services experience improved retention in care and viral suppression compared to all PLWH in the U.S.. Unfortunately, getting eligible PLWH enrolled into the RWHAP is only one step in helping these vulnerable and hard to reach clients. In many jurisdictions, the primary reason RWHAP clients lose access to services is disenrollment due to failure to recertify. NASTAD believes HAB should move to an annual recertification process for RWHAP enrollment. This change would have the following effects as described by Ryan White Part A and B receipients:

  • Changing the six-month recertification requirement would minimize the threshold for all clients, especially those dealing with unstable housing, comorbidities, and behavioral health issues. Eligibility information varies little from recertification to recertification for a large swathe of clients. Despite this, RWHAP programs cannot provide services to clients who fail to provide documentation of eligibility, thus interrupting their access to care. This is especially disruptive if ADAP is paying a client's insurance premium. In this instance, the client will likely lose their health insurance and remain uninsured until open enrollment or they experience a qualifying life event.
  • Even if the lapse is minimal, clients may lose insurance coverage, have their treatment adherence negatively impacted, or even fall out of care. The risk of medical harm to our clients as a result is significant. The most negatively impacted clients are those already most vulnerable to falling out of care due to service interruptions caused by the need to recertify for RWHAP services.
  • Bi-annual re-certification places an undue burden on clients living in rural locations throughout the country. Some clients may live hundreds of miles from their provider and case manager.
  • In addition to client burden, the administrative burden is significantly increased due to the six-month recertification requirement. Eligibility determination is conducted internally by RWHAP staff, and the administrative tasks to coordinate recertification twice annually without exceeding the 10% administrative cap requirement can be challenging. Additionally, the coordination of service provisions such as health insurance premium payments, emergency financial assistance, oral health services, food bank, and transportation services become more difficult and may be interrupted due to semi-annual recertification.
  • An annual recertification would move the RWHAP into closer alignment with many other federally funded programs aimed at improving the health and nutrition of vulnerable populations.

Extending the recertification timeframe from six months to 12 months will allow clients and case managers to focus their energy on the primary goals of the RWHAP, including improving access to HIV medical care and supporting clients to achieve improved health outcomes. This would reduce the amount of time that clients and case managers spend gathering and processing paperwork rather than focusing on improving health outcomes and pursuing other goals identified by the client. HAB should also undertake efforts to assist recipients in the same jurisdiction to coordinate and streamline their eligibility systems and data.

New Hanover Regional Medical Center, Wilmington, NC

The requirement for six-month recertification of eligibility for RWHAP clients is extremely burdensome for both providers and clients.

Many of our clients are challenged to provide financials several times a year to different agencies for case management, ADAP, medical care, support services, etc. I think ideally there should be a state-wide website that keeps annual eligibility on all clients, as they often lead transient lifestyles that take them to different places. Perhaps the state ADAP websites could be modified for this purpose- I know CareWare has the ability to record annual reviews of income, insurance, etc. We use CW to share this info with Part B, C and D in our region so the client only has to apply one time at one place. I also think patients should have part of the responsibility to let us know if there is a change in income or insurance.

Client eligibility is one of the most common findings for HRSA site visits. Trying to keep up with client eligibility every 6 months is extremely challenging. Our patients are in and out of care; when they present back to us (as they usually do) if their eligibility is expired we can’t use Ryan White to help them. With level or reduced funding in states that did not expand Medicaid, manpower needs to focus more on actual care than chasing down clients for a pay stub.

New York City Department of Health and Mental Hygiene, Queens, NY

The Health Department suggests that, at a minimum, HRSA eliminate the six-month recertification requirement. The eligibility screening can create barriers to care and service delivery. Clients may view recertification as unnecessary and burdensome, as many clients’ income rarely, if ever, changes (e.g., many clients receiving public benefits) or is so far below Ryan White eligibility criteria that any change is unlikely to affect eligibility. Jurisdictions should have greater flexibility to develop their own eligibility recertification policies, including how often recertification is necessary, a determination that should be based on local factors such as client demographics, local eligibility criteria, and service categories (e.g., imposing stricter criteria for those clients potentially eligible for Medicaid reimbursement).

NYC Department of Health & Mental Hygiene, Long Island City, NY

  • One client said "I think that the consumer should be told that they don't have to answer all the questions if they are feeling uncomfortable. The consumer has a right to privacy. Not ALL questions are relevant to get services".
  • After waiting 90 mins, following intake, client (who was homeless) got few answers to his questions, nor was he given any referrals for shelter that evening. He was provided with a pantry bag filled with canned goods without a can opener. After completing re-certification process, client was still unsure as to what his past drug/alcohol history had to do with his current situation — being homeless and food insecure — and in need of services. The client left with that feeling that providers' needs were first priority, clients' were secondary.
  • One client reported feeling that the question "Have you ever been paid to have sex?" was an invasion into that individual's privacy, especially so soon after diagnosis, and left that client feeling "disgusted and revolted". Client felt that this question does not acknowledge, without regard to personal history, that clients are human beings with feelings. This question or line of questioning should be eliminated.
  • One client with many needs who had never sought services before felt shame and was both overwhelmed and willing to answer the questions (in order to get services), particularly in response to the client's mental health history. Although the client is no longer receiving any treatment for mental health issues, the client felt that the volume and intensity of mental health-related questions and the assignation of a mental health case manager was a pre-requisite for receiving housing services.
  • A client who has recently returned to work underwent a 45-60 minute, 20 page questionnaire of duplicated questions, seeking the relevance of such questions in his quest to return to work and never had any follow up communication with the agency. It is this client's impression that many case managers are not skilled enough to answer questions with accuracy or relevant information.
  • Another client noted that while the questions are intrusive and can be shocking to the new client, the information can be of value when used for planning purposes.
    Many times, the repeat questions are simply demographic. It was noted that questions regarding past sexual history are not seen as frequently by some clients.
  • One client felt uncomfortable with questions asking how many sexual partners the client had in a stated period of time and questioned its relevancy to the receipt of services.
  • Another client felt re-traumatized by having to repeatedly recount early sexual experiences, history of alcohol/drug use and mental health issues, made more acute when referred to other agencies providing additional services.

Partnership Comprehensive Care Practice, Philadelphia, PA

The Ryan White certification process is particularly burdensome to those medical case management programs located within medical clinics. This activity consumes a great deal of time that could otherwise be spent directly helping patients.

In our clinic, at least two thirds of our patients are on Medical Assistance or our state ADAP program. There is very little change in their income and insurance status and so documenting Ryan White eligibility takes a lot of time for very little result. Additionally, in clinic based settings there are two separate software databases maintained. One that is the Electronic Medical Record that is maintained by the medical institution and the other is CAREWare which is mandated for reporting to HRSA. Case managers have to document Ryan White eligibility in both software programs, which makes this process very time consuming.

To summarize:

  • RW eligibility documentation is time consuming in itself.
  • RW eligibility documentation in a clinic setting is doubly time consuming.
  • RW eligibility documentation in our clinic setting changes very little in the course of a year such that documenting RW eligibility twice a year is largely unnecessary.

Please take this information seriously as any reduction in redundant paperwork (screen time) would result in an increase in face to face patient care.

Pennsylvania HIV Planning Group, Harrisburg, PA

Annual eligibility screening and six-month recertification of eligibility for RWHAP clients is redundant and evasive for both clients and their case managers. It becomes burdensome on the agencies when their main interest is to provide services to clients. Many of our client's information for eligibility of services does not change in a six-month period. Agencies essentially collect the same information twice a year.

The Pennsylvania ADAP program, Special Pharmaceutical Benefits Program (SPBP), recently implemented an annual full eligibility application and a six-month Express Application. The six-month Express Application streamlines the process by ensuring that the conditions that made a client eligible six months earlier have not changed or collects information that may have changed to ensure further eligibility. (These include items such as address changes, income changes, disability status, etc.) Until there is a cure an individual eligible by virtue of their HIV positive status will remain positive for the rest of their lives.

I personally recommend that HRSA's HIV Bureau (HAB) implement a similar process to Pennsylvania's SPBP protocol that continues to ensure eligibility for clients and decreases redundancy while also reducing burdensome processes for agencies and their case managers so they may use their time more effectively and efficiently to serve clients.

Powers Pyles Sutter & Verville PC, Washington, DC

RFI section C.3 states that HAB is considering eliminating the six-month recertification requirement related to income and insurance status for RWHAP grant recipients. RWC-340B supports elimination of the six-month recertification requirement for RWHAP grant recipients.

First, the six-month recertification is challenging for grant recipients to implement. RWHAP providers work diligently to build trust with their clients and requesting the six-month recertification is viewed by many clients as a statement of mistrust from the RWHAP provider. The six-month recertification requirement creates a strain between the RWHAP provider and the patient. Most individuals, regardless of HIV/AIDS status, are reluctant to share information about their financial status. It forces RWHAP providers to either inform their clients that their services will no longer be covered by the RWHAP if the client does not complete the recertification or to continue to furnish services without charging the grant. Second, the six-month recertification is unnecessary. In the experience of RWC-340B members, it is extremely unusual for a client’s financial situation to change significantly in a six month period such that the client is no longer eligible for RWHAP services. Third, at its worst, the policy results in a patient losing RWHAP assistance simply because the patient is reluctant to provide information for the recertification and not because the patient is ineligible. RWHAP providers prefer to focus on medication adherence and other case management services, rather than an unnecessary bureaucratic formality.

RWC-340B recognizes that the Ryan White program is the payer of last resort and that it is important that HAB provided funding only for services for qualified individuals. However, an annual certification comports with most financial reporting practices and should be sufficient to ensure that Ryan White funds are not spent on services for individuals who do not qualify financially.

Prism Health North Texas, Dallas, TX

Implementation of the six month recertification policy to assess Ryan White HIV/AIDS Program (RWHAP) client eligibility has created an undue burden on individuals accessing the program and in some cases has impeded access to care among the most vulnerable populations served.

The requirement to maintain program eligibility currently necessitates clients to be recertified at minimum every six months to evidence any changes in residency, income and/or insurance status. While HRSA provides flexibility in the implementation of this policy, the policy has none-the-less become onerous and in particular has created access issues for some of the most vulnerable populations of focus. Individuals experiencing homelessness, substance mis-use and/or mental health disorders particularly struggle to maintain eligibility documentation required to access care. For those who experience homelessness they may not be in a location that is either sheltered or safe and therefore they are unable to securely maintain critically needed papers such as social security letters for proof of income.

It is the experience of this agency that many of these vulnerable clients do lose their eligibility to access Ryan White services resulting in disruptions to their continuity of care. Despite staff explicitly knowing that there are no changes in status regarding residency, income and/or insurance status, the staff and clients still must demonstrate compliance with the policy requiring additional effort and time. This eligibility process impacts client access to needed support and has become an arduous practice particularly given most clients do not experience a change that impacts their eligibility for services within the six month time frame.

Many individuals who are retired and/or receive social security payments (SSDI/SSI) are on a fixed income which doesn't change during the year. These individuals have a documented insured status which also doesn’t change and these individuals tend not to move frequently. Requiring them to go through an unnecessary eligibility process creates a needless burden on the individual and utilizes system resources to process a requirement without cause thereby creating inefficiencies in the usage of limited Ryan White funding.

Finally, there is an additional administrative burden with regard to the implementation of this policy. Because HRSA RWHAP allows their contracted local administrative agencies the ability to define program requirements more precisely, more layers of administrative burden may occur. This is the case in Dallas, Texas where the local administrative process does not allow individuals with no noted changes to their eligibility the opportunity to provide a self-attestation of no change by phone or email, as allowed by HRSA. They further require the client to provide current versions of their original eligibility documentation for their six month recertification thereby resulting in a more onerous policy. This increases filing burdens and importantly intensifies the procedural impact on clients by requiring them to physically engage with an appointment and reproduce documentation to recertify eligibility for services. The six-month recertification process is extremely cumbersome for both clients and providers of care and does impact access to care.

Public Health – Seattle & King County, Seattle, WA

The recertification requirement is burdensome to many clients as they do not experience income or healthcare coverage changes significant enough to disqualify them for RWHAP services. In our jurisdiction, our overall population of PLWH is 91% diagnosed, 82% engaged in care, and 75% suppressed viral load; and our Ryan White engagement in care and viral load suppression are at 85%. We are proud of the accomplishments of our Ryan White funded partners for getting us to these levels. And as we work to get the 9% of the PLWH who do not know their status, we expect that many of the people who comprise that 9% are going to have significant barriers (homelessness, substance use disorder, serious mental illness, stigma, cultural barriers, etc.). This requirement poses an unnecessary burden on clients, especially those who are might have issues accessing or retaining paperwork. It would be a shame if this client was denied services because this bureaucratic barrier kept an otherwise engaged client from achieving viral load suppression.

San Antonio HIV Health Services Planning Council, San Antonio, TX

In reference to RFI section C.3, the San Antonio Area Planning Council, Administrative Agency, Service Providers, CQM Committee, the CQM SPOC Committee, and the Regional TX/LA Part A/B Group are all in agreement that the recertification process is extremely burdensome on the client and service providers. We all strongly support there NOT being a recertification process. The current recertification process for both Ryan White and THMP is extremely cumbersome on our clients, especially given the fact that not much changes for them in a 6 month period.

HAB has provided consistent policy guidance on the annual eligibility screening and six-month recertification of eligibility for RWHAP clients (HIV/AIDS Bureau’s PCN 13-02, “Clarifications on Ryan White Program Client Eligibility Determinations and Recertifications Requirements (PDF - 40kb)"); however, RWHAP grant recipients remain challenged to implement the policy in the field. Formal reviews and grant recipient reporting describe several inconsistencies in the application of the recertification requirement by RWHAP grant recipient. In addition, some grant recipients report that the recertification requirement is burdensome as many of their clients do not experience income or healthcare coverage changes significant enough to disqualify them for RWHAP services. HAB is seeking input to understand the impact and burden of the six-month recertification policy to assess RWHAP client eligibility for services. HAB is considering how to minimize the impact on patients' access to medical services, retention in care, access to HIV antiretroviral medications, and ultimately reaching viral suppression.

SFDPH - HIV Health Services, San Francisco, CA

The burden of the six-month recertification policy for RWHAP client eligibility can indeed create barriers to care, and the impact is perhaps most significant on clients needing medications from AIDS Drug Assistance Programs. Many of these clients have limited incomes from essentially static public benefits and are in any case substantially below income eligibility thresholds. Jurisdictions should be able to assess local factors, including client demographics, assessments of need and state Medicaid reimbursement to develop their own recertification policies.

State of Wisconsin Department of Health Services AIDS/HIV Program, Madison, WI

The Wisconsin Department of Health Services (DHS) urges HRSA to take any possible steps to minimize the impact of the six-month recertification policy on patients' access to medical services, retention in care, access to HIV antiretroviral medications, and reaching viral suppression. Agencies funded by Wisconsin DHS report that people living with HIV (PLWH) express frustration with the six-month recertification policy, and this harms job satisfaction for case managers and service providers.

The six-month income recertification policy disproportionately impacts people with lower incomes, who often have multiple, short-term income sources such as seasonal or temporary work. Income for these people living with HIV may often change slightly multiple times per year, but almost never changes enough to affect a person’s eligibility for the Ryan White program in Wisconsin. For these clients, income recertification is burdensome and can delay care unnecessarily. Wisconsin DHS requests that HRSA consider reducing the six-month recertification requirement to a twelve-month recertification requirement.

Suffolk Project for AIDS Resource Coordination (SPARC), Riverhead, NY

I am writing in response to HRSA's Request for Information on Administrative Streamlining and Burden Reduction, specifically the Bureau of Primary Health Care's request regarding eligibility screening and six-month recertification of eligibility (RFI section C.3.). HRSA's current guidance for Eligibility Determinations and Recertification indicates that HIV Status must be documented initially while Income, Residency and Insurance Status must be documented annually with self-attestation permitted at 6-month recertification if there have been no changes. As a recipient/sub-recipient of Ryan White funding through Parts A, B and D, I can attest that the current requirements for documenting eligibility are not only burdensome for staff (taking time away from actually providing clients with needed services) but create a barrier to care for many of our clients in greatest need of services who are living and/or working in situations that make obtaining eligibility documentation extremely difficult (i.e., no pay stubs, no bills in their name). Many of our clients are living with and/or supported by a family member, partner or friend who is unaware of their HIV status and/or sexual orientation and therefore having to ask this individual to provide some type of proof of income or residency raises questions that may place our client at increased risk for domestic violence or homelessness. This situation is further complicated when the individual supporting the client is themselves undocumented, works off-the-books or does not have permission from their landlord to have the client in their house/apartment. While I understand the importance of establishing that all clients receiving Ryan White funded services are eligible to receive those services, the majority of our clients do not experience dramatic changes from one year to the next that would impact on their continued eligibility. For instance, they may go from one poorly paid, off-the-books job to another or from one inappropriate/unstable housing situation to another but they are still living below the Federal poverty level and in the same county.

I do not believe that it is HRSA's intent for recipients/sub-recipients to deny Ryan White services to an individual who is an established client of a program and is clearly still eligible to receive services merely because they have not provided updated documentation that indicates their place of residency or level of income. I think that after initial eligibility is established, it would be more reasonable for Ryan White program recipients/sub-recipients to re-certify eligibility annually rather than every 6 months (with self-attestation of no change being acceptable, particularly for Income and Residency). I do think it is reasonable, however, to check Insurance Status every 6 months to ensure that if a client has somehow lost their medical insurance during this time, the program can provide prompt assistance/referrals to either obtain new insurance or reinstatement/reactivation of the client's previous insurance coverage.

For Initial Eligibility Determinations, I believe that if a client has already provided proof of income and residency to another government program that serves low-income individuals (such as a state's ADAP program or a county's home heating assistance program), that their active status with this other program should be considered to be acceptable documentation of eligibility for receipt of Ryan White services. An administrative burden is created for both clients and staff when each agency providing Ryan White services to a client must collect their own eligibility documentation and recertify eligibility every 6 months. In situations where a client has no form of official documentation of income or residency, a statement attesting to where they live and/or how they are supporting themselves should be sufficient to establish eligibility. A requirement that such a statement be notarized creates a barrier to care without providing any greater proof of accuracy (a notarized document simply means that the client has provided proof of their identity, not that the information contained in the document is accurate) and unless the a client has a bank account, they will likely be charged a fee to have their statement notarized. When documenting HIV Status for Initial Eligibility Determination, a note from the treating clinician in the medical record indicating that the client has HIV infection (or AIDS) should be sufficient. Requiring that a program have a record of a positive HIV test result or a detectable HIV viral load test is unreasonably burdensome when a client has an undetectable HIV viral load for many years and has been in care long enough (often at multiple facilities) that their initial HIV test result is no longer available.

The Callie Clinic, Sherman, TX

  • The six-month recertification process is burdensome as most of our clients are on fixed incomes from the federal government (social security). They receive one award letter a year and their income does not change after the receipt of the award letter. Very little is accomplished of value other than creating additional paperwork for the organization that does not substantially add new information on client eligibility.
  • There are different eligibility requirements contingent on the funding stream. Streamline process to align with other Federal awarding agency. We receive HOPWA/HUD funding and for them household program eligibility must be recertified annually (every 12 months) at a minimum.
  • State of Texas interpretation of when to do annual recertification and six-month recertification is extremely difficult to track for all of our clients. Texas DSHS require us to do annual recertification on their date of birth and six-month recertification six months from their date of birth. Prior to the State of Texas telling us when recertification’s would take place for our clients, our organization had determined that annual would occur for all clients in January and six-month recertification would occur for all clients in July. For our organization, this was an easier way for clients and staff to remember when these activities must be done. In addition, many federally subsidized housing facility have their clients do annual recertification one month a year. Again, clients know the routine and staff know the routine.

Unity Wellness Center, Opelika, AL

Comment #1

In an attempt to eliminate barriers to care for PLWHA, I urge you to please remove the six-month recertification requirement for RWB Clients. The six-month recertification requirement is burdensome as many clients do not experience income or healthcare coverage changes significant enough to disqualify them for RWHAP services. It creates an unnecessary waste of resources, both of paper and Case Manager time, and it is often a hassle to our Clients, who experience enough inconveniences in their daily lives.

In my 3 years as a Linkage Coordinator for an ASO in rural Alabama, I can safely assure you that only 2-3 of my hundreds of Clients have reported any changes in income or address that would disqualify them from the program at their 6 month recertification. Those 2-3 Clients who have reported changes were in the process of moving out of state and were therefore transferred to another Clinic.

Please consider making this positive change to the program. It will improve the operation of RWB programs for both Clients and Clinic staff, and it will allow us to focus on more pressing daily issues.

Comment #2

I would like to take a moment to suggest that the AIAP/ADAP 6 month recertification be eliminated. Many clients, from my experience, do not have significant changes, or any changes at all during the 6 month update. It creates a barriers to care and many of our clients are already experiencing significant barriers. The 6 month is adding to the list of barriers that our clients are already experiencing. Client lose insurance unnecessarily due to the 6 month review. Eliminating the 6 month will only assist our clients better and we will be able to provide better, longer lasting care.

Comment #3

I am taking the opportunity today to request that you cease the six-month recertification for RWHAP clients. This six-month recertification adds a great deal of burden on our clients as well as the caseworkers. This requirement is not required for other programs, so one has to wonder why it is required for this one. In the three years I have been working with this population, I have had precisely ONE individual who had a change of address or income in the six month time period for the recertification. That is ONE change in approximately 500 recertifications that I have completed. It seems like there could be a far better use of everyone's time and resources.

Comment #4

I'm writing today to support the push for a removal of the six-month recertification for Ryan White HIV/AIDS recipients. As a Ryan White Social Worker at an ASO, I encounter Clients who experience a plethora of barriers to care. Very, very rarely do I see any clients move UP beyond the 400% federal poverty level (or experience any other form of R.W. disqualifying event) and outside the Ryan White services umbrella. The six-month recertification stands as just another barrier preventing clients from remaining in care and receiving the services that they need. I do hope you consider this message in your decision making. Thank you.

Comment #5

As the Clinical Coordinator of a rural Aids Service Organization (ASO) I would like to express my support for discontinuing the mandatory six month recertification requirement. Typically it is a mere exercise in redundancy as few things change in six months. As is typical of most ASOs, we are inundated with paperwork. Our clinic answers to numerous oversight committees, we fall under the direction of a larger ASO whose Medical Director oversees us. As well as a regional hospital that has two Attendings, one for family practice and one for infectious disease who are collaboratives for our Nurse Practioner. These are just a few of the many regulatory entities that monitor us locally and do not include the time and paperwork Medicaid, Medicare, private insurance and the un- or underinsured patients require.

As many ASOs do, we work with a skeleton crew and each employee has more than one job. Decreasing the workload by requiring a twelve month recertification will certainly streamline the process. The undue burden of the six month recert also impacts our patients. Transportation is a huge issue for most of our patients. While we do provide it to those who are eligible, many patients cannot easily get to clinic at the time the six month recertification process calls for. Please keep these barriers to care in mind when making your decision concerning the recertification process.

Comment #6

In an attempt to eliminate barriers to care for PLWHA, I urge you to please remove the six-month recertification requirement for RWB Clients. The six-month recertification requirement is burdensome as many clients do not experience income or healthcare coverage changes significant enough to disqualify them for RWHAP services. It creates an unnecessary waste of resources, both of paper and Case Manager time, and it is often a hassle to our Clients, who experience enough inconveniences in their daily lives.

In my 3 years as a Linkage Coordinator for an ASO in rural Alabama, I can safely assure you that only 2-3 of my hundreds of Clients have reported any changes in income or address that would disqualify them from the program at their 6 month recertification. Those 2-3 Clients who have reported changes were in the process of moving out of state and were therefore transferred to another Clinic.

Please consider making this positive change to the program. It will improve the operation of RWB programs for both Clients and Clinic staff, and it will allow us to focus on more pressing daily issues.

University of Massachusetts Medical School, Worcester, MA

The administrative burden of complying with PCN-13-02 is a challenge for our organization and is not helpful or beneficial to patients. As a Part C medical provider, our power to compel our patients to comply with this regulation is severely limited. I do not believe that HRSA or our parent organization would want us to refuse patients medical care, or ancillary services relevant to medical care, because the patient does not provide a written verification of their income. Some patients are very suspicious of a process that they consider “government intrusion” in their affairs; this is particularly true for patients with substance use, mental health issues and/or are foreign born. Although we do our best to encourage patients to provide their income statements twice per year, a heavy-handed approach could cause them to disengage from medical care. We believe that retention to care and viral load suppression are far more important than how poor our patients are.

At present, our medical case managers struggle with this issue on a daily basis. With over 700 patients, it is difficult to quantify the number of hours spent on gathering this information, which changes very little for the overwhelming majority of our patients. Most patients do not experience income or healthcare coverage changes significant enough to disqualify them for RWHAP services. They are often on some form of public assistance which changes very little from year-to-year; others are only working part-time in minimum wage jobs.

We believe that this reporting burden limits the amount of time our medical case managers could be working with patients on issues that actually impact their health, such as medication adherence, harm reduction, and housing and food security.

The following is a snapshot we believe illustrates our argument. Since 1/1/2015 we have had 595 clients stay in care with us through 12/31/17; you will note that there is very little change from year-to-year—not to mention the six-month period of time required by PCN-13-02.

Poverty Level <100% 100-138% 139-200% 201-250% 251-400% 401-500% >500%
2015 54% 14% 10% 7% 7% 4% 4%
2016 54% 14% 10% 7% 7% 4% 4%
2017 53% 16% 9% 7% 7% 4% 3%

University of Mississippi Health Care, Jackson, MS

The 6-month eligibility determination is quite burdensome both to the agencies and to the clients. This is particularly difficult for clients do not have typical paychecks that they can get a copy of, and for clients who don’t have any significant change in income for years and years. I would suggest that this be done on an annual basis rather than biannually. Thank you.

University of Mississippi Medical Center, Jackson, MS

Indigent patients are unlikely to have major fluctuations in their financial need given the very low likelihood of pulling oneself out of poverty over an entire lifetime if born into poverty. Certification done once a year, every five years, one time only are likely to be highly predictive of ongoing financial need.

UPMC Pinnacle, Harrisburg, PA

Annual eligibility is reasonable but six-month recertification of eligibility is unduly burdensome. Six month recertification impedes access to services in the following ways:

  1. Patients experience lapse in medications when they are unable to complete paperwork every 6 months for ADAP eligibility
  2. Patients experience lapse in coverage for medical appointments using HIP when they are unable to complete paperwork every 6 months for Ryan White eligibility
  3. Attestation does not provide any additional or verifiable information or data because documentation is not required and patients may just be checking a box without evaluating changes in their income or insurance status.
  4. Clients do not experience significant income or healthcare coverage changes every six months that would disqualify them from the program. They are only becoming disqualified due to administrative burden, when in fact they are eligible for services that they are then denied.
  5. Finally, the recertification process every six months is a waste of Ryan White administrative dollars as Ryan White staff are completing unnecessary and burdensome paperwork, wasting time that could be spent on client services.

University of Wisconsin School of Medicine and Public Health, Madison, WI

We strongly support HRSA's review of the six-month recertification requirement for Ryan White eligibility. Individuals who are eligible for Ryan White services rarely experience income or healthcare coverage changes that would disqualify them for Ryan White coverage. In addition, the individuals who can benefit the most from Ryan White funded services are the ones who struggle the most with administrative requirements. At the time of the ADAP six-month recertification deadline, several of our patients usually fail to return paperwork to the state, are removed from ADAP coverage, are unable to refill their medications and experience a gap in medication adherence due to this administrative burden. Patients are also on varying schedules for return medical visits which don’t always line up with the 6 month recertification timeline. This can be challenging for our program staff to ensure that a recertification happens within the 6 month timeframe. We would recommend that instead of imposing an administratively burdensome 6 month requirement, HRSA move to a best practice model, where Ryan White programs are encouraged to develop systems to incorporate continuous screening for changes in healthcare coverage eligibility into office visits, medication refill requests, and medical case management services, with documentation of a formal eligibility assessment still required at least annually. We would also recommend that HRSA allow Ryan White programs to use enrollment in other programs that assess income and residency as eligibility documentation whenever possible to reduce waste of federal resources on duplicative tasks. For example, if a client was deemed eligible for Medicaid and the eligibility requirements for Medicaid are more restrictive than Ryan White eligibility then allow Ryan White programs to use the Medicaid enrollment verification as documentation for Ryan White eligibility (in lieu of collecting residency and income documentation).

Vanderbilt Health at One Hundred Oaks, Nashville, TN

Paperwork Reduction

In Tennessee, we have a centralized, electronic eligibility system for the state that all case managers and service providers are able to access. Despite this centralized system, each program requires paperwork with the same demographic information to enroll patients in specific services. If a patient requires all of the Ryan White services like Insurance Assistance, dental and vision, then the case manager has to complete five separate forms with the same demographic information (name, DOB, address, SSN, phone number):

  1. 3716 in RWES
  2. Insurance Assistance Program application to be sent to IAP
  3. Dental assistance program to be sent to the dental program
  4. Vision care application to be sent to United Way
  5. Physician referral form for vision care

Because all of the Ryan White programs have access to RWES, these additional applications are not necessary. It takes about 15 minutes to complete and send the documentation to the various providers. Despite receiving a receipt from the secure file transfer site, the programs frequently indicate that they have not receive applications, then the medical case manager must resend the documentation which delays patient care.

I propose that all providers utilize the Ryan White Eligibility System for their application information instead of three separate applications.

6-month Eligibility Recertification

Most patients do not experience significant enough changes in their income to disqualify from Ryan White services, particularly those who receive social security. Because these patients are on a fixed income, it is difficult for them to pay for transportation to medical appointments and to a recertification appointment. While we do our best to coordinate care, it is not always possible with various provider schedules. I propose that patients who have primary income from social security have a less frequent recertification process.

Many patients are computer-literate and would be willing to provide their documentation via email or a secure file transfer. I would like to see an investment in technology to facilitate this type of programming that would permit patients to enroll and recertify from their homes.

Victory Program Incorporated, Boston, MA

As a sub-grant recipient providing RWHAP Part A support services in Massachusetts, the recertification requirement is burdensome for many reasons. As indicated, the vast majority of individuals served by our program do not experience income or healthcare coverage changes significant enough to impact their eligibility for RWHAP services. Massachusetts has determined that the income guideline for service eligibility be set at 500% of the FPL. An analysis of the 860 unduplicated individuals served by our organization in FY17 indicates that more than 86% of individuals fall under 200% of FPL. Only 1% of individuals served by our program (11 people) had incomes greater than 500% of FPL. In addition, a deeper look indicates that the vast majority of these clients have remained in the same FPL category for several years.

Our organization operates a low-threshold community drop in center for individuals living with HIV/AIDS, where over the years we have provided a variety of RWHAP services, including meals and peer support. Clients who utilize services are often homeless, or unstably housed; struggle with multiple complex issues including substance use, co-occurring mental health and/or medical issues (in addition to HIV); were recently incarcerated, or have histories of incarceration/criminal justice involvement; have been impacted by violence and trauma; and are impacted on a daily basis living with multiple stigmatized identities. Often, these RWHAP services are the first place individuals “show up” when they have fallen out of care. Staff work hard, sometimes over weeks, to build rapport with this transient population in order to move towards re-engagement in care. Constantly having to ask individuals to bring in documentation that they don’t have (lost; can’t find; etc.), or are unable or unwilling to go get creates significant barriers in building rapport and helping folks to re-engage in care (“you care more about my social security print-out than me”). Staff time gets shifted to satisfying the burden of required documentation instead of delivering much needed services. As a result, clients avoid staff or stop coming in all together, thereby remaining disengaged from care (not seeing doctors; not accessing ART; not virally suppressed).

Organizations providing RWHAP support services, in particular those services that are not reimbursable by insurance (home-delivered meals; peer support; housing search and advocacy; etc.), are more often than not delivering these services in community-based settings. Because of this, staff typically do not have access to the centralized information systems that hospitals and clinics use to verify insurance. Even if they do have access to the insurance verification systems, there are no centralized systems (in Massachusetts) to verify income. Staff have to rely on clients who are struggling just to survive to bring in the documentation.

Recommendations:

Since Medicaid eligibility/enrollment is income-based, providers should be able to use documentation of current Medicaid enrollment to satisfy “income documentation” (as well as “insurance documentation”). The Masshealth eligibility guideline from 3/1/18 – 2/29/19, is $3,086 monthly or $37,032 per year for single household. As previously stated, the majority of our members served will fall well within that maximum threshold to remain insured. We recommend that proof of Masshealth insurance also serve as acceptable proof of income in order to reduce documentation burden.

Overall the 6 month reassessment of need paperwork is extremely burdensome. There is heavy focus on administrative staff to obtain this information, just to remain in compliance. When it comes to audits, we typically have been able to obtain yearly updated paperwork; though this is still difficult, it is reasonable to assess changes in income/residency/insurance yearly. Any/all citations we have received in recent years are the result of not showing this recert proof at the 6 month interval. Due to the nature of our drop in community based services, and the population we serve, it has been difficult setting the expectations that members need to bring in this extensive amount of documentation every 6 months. (Especially when many have higher priority issues such as finding a place to live, reconnecting to care, improving medication adherence, etc)

Additionally, it is our hope to shift the concentration of our support staff role to enhance the outcomes based reporting, rather than proof of paperwork. We recommend eliminate the 6 month recent and/or increase the allowable administrative staff capacity. The funder administrative cap for staff has not increased; though, we still must obtain extensive amount of documentation without any additional FTE support. With the increasing shift to outcomes based reporting, this ultimately divides our staff resources. In some ways we need to decide where the administrative focus will be: outcome measures/enhancing reporting/brainstorming new ways to engage clients currently out of care…or we decided to push to “get your income updates done and bring in your new paperwork” while we reach out to clients and providers to obtain information.

Virginia Commonwealth University, Richmond, VA

The Virginia Commonwealth University (VCU) Ryan White Program (RWP) is located in an urban academic-healthcare setting. The VCU RWP provides core and support services to eligible patients receiving HIV-Care at the Infectious Disease Clinic location(s). Approximately 2000 patients are served under the VCU RWP annually. Table 1 (below) describes the poverty level of the patient population served. 78% of VCU RWP patients served in the past twelve months have income under 200% of the federal poverty level (FPL).

Table 1: Federal Poverty Table
FPL Patient Count
0-100% 929
101-200% 434
201-300% 187
301-400% 95
401-500% 48
>500% 51

Eligibility efforts mirror the state of Virginia in that, as reported in the annual report to the General Assembly by the Virginia Department of Health, the majority (63%) of Direct ADAP recipients are at or below 100% of the FPL.

The VCU RWP has a current policy in place requiring annual eligibility screening and six-month recertification for Ryan White HIV/AIDS Program (RWHAP) clients as required under PCN 13-02. The VCU RWP follows the Ryan White Part B eligibility guidelines allowing patients under 500% of the FPL access to RWHAP funding. Less than 3% of the patients served have income above 500% FPL.

During the HRSA technical site visit the VCU RWP received in May 2016, the consumer panel addressed concerns related to accessing services due to the overwhelming requirements surrounding eligibility. Primarily, the requirement to complete a six-month recertification although income has not changed or has not changed significantly enough to result in a change of eligibility status.

The VCU RWP began a quality improvement project (QIP) to first address annual eligibility and secondly, to address six-month recertification (see graph below). Through the success of this project the VCU RWP was able to increase overall annual eligibility. Once six-month re-certifications were added to the QIP, overall eligibility began to decrease although there were not significant changes/changes at all in an individual’s financial status.

Results of the VCU Ryan White Program Quality Improvement Project

In order to complete this QIP, the following additional administrative actions were implemented. This highlights the administrative burden placed on patients and staff alike. Weekly data reports provided to all staff identifying patients as eligible or ineligible, broken down by case manager (estimated time to access and put into usable form – 10 hours of data staff time per week)

  • Increase in staffing to support eligibility efforts (hired 2 eligibility coordinators)
  • Increase generalized patient communication through newsletters, mass mailings, and electronic displays in the clinic waiting area to specifically highlight eligibility requirements (2 - 4 hours per week)
  • Mailing of individualized patient letters to request specific documents related to eligibility (10 hours of clerical time per week)
  • The support of an annual eligibility and insurance enrollment event (80 hours planning; 1 full day of 80% of staff during event day)
  • Revised job descriptions for all RWP staff to include requirement of eligibility assurance (10 hours per week, per Case Manager spent on eligibility.)

Despite this enormous addition of administrative, clerical, and case management time, the VCU RWP is as yet unable to fully fulfill the implementation of PCN 13-02. Overall, we remain committed to addressing eligibility and adding staff and administrative time to this objective. However, our data supports that the additional 6 month eligibility leads to limited identification of clients who are truly ineligible. The additional information gained rarely identifies a patient who has become ineligible. However, the additional burden on staff time effectively leads to diminished time for provision of core services to patients who are eligible.

Waterloo Counseling Center, Austin, TX

In my TGA, we used to be required to recertify on the client's six-month service anniversary and one-year service anniversary. We are now required to recertify in the client’s birthday month and half-birthday month. This adds an undue burden to both staff and the client. For example, if the client enters services in July, completes the arduous paperwork required for entry into RW, and has a birthday or half birthday in August, the client has to recertify that information all over again. Waiting until the next six-month occurrence would put the client out of compliance. They have to do this at every agency they encounter, and for some that can be four or five places.

The paperwork burden has been a source of consternation to our clients and a serious barrier to service for many years, and I hope we can address it. Clients report feeling demoralized, discriminated against, dehumanized, and overwhelmed. Some simply walk away from services rather than go through it all again. It damages provider credibility with clients and makes us look like bureaucrats who do not care about them.

It also diverts time from serving clients to non-service-based tasks. I know of one agency here that has frequent turnover in staff due to this issue. Staff take jobs like these to help people and are put in the position of policing them and denying services if they go one day past their eligibility.

I know of one program here that simply buckled under the growing and unnecessary undue burden of paperwork and is no longer available to clients. I know that is not the intent of HRSA and I hope we can remain in compliance, but address this issue.

Western North Carolina Community Health Services/ Minnie Jones Health Center, Asheville, NC

In my experience it is very difficult to have patients come in every six months for recertification, as most of the time the status of the patient e.g. Poverty Level, Income, insurance status, etc. has not changed to the degree that they would no longer qualify to receive Ryan White Services. The staff time required for an agency to do this for 750 patients twice a year is burdensome.

At a minimum please consider a "verbal" verification from the patient that their eligibility status has not changed in the past six months. This could be accomplished with a phone call. A standardized form could be used to indicate the date the Ryan White client verbally verified their unchanged status. This form could act as the 6 month recertification. Otherwise, our service area is rural and covers 18 counties. It is very burdensome for many patients to take a half a day off from work to drive to our health center to fill out a couple of pieces of paper verifying their status hasn't changed in 6 months.

Whitman-Walker Health, Washington, DC

The six-month recertification requirements are too burdensome on patients and providers. The work necessary for a six-month recertification includes: contacting each patient to notify about the need for new documentation, which generally includes sending a letter to the patient and then following up by phone or otherwise; meeting with each patient to obtain the new documentation; scanning that documentation in the patient’s electronic health record and making other necessary additions to the medical record. This process is labor intensive for both the patient and the staff. The process burdens, and in effect, stigmatizes Ryan White clients by putting them through a burdensome process that their peers, not designated as Ryan White clients, do not experience. Many requirements do not change from the previous six months, so clients are required to submit much of the same information for each recertification. Many if not most public insurance and public benefit programs require annual recertifications. In addition, with the advent of "passive recertifications" for many programs, the state agency matches information electronically to confirm continuing eligibility and a beneficiary frequently needs to provide no additional documentation or to take any further action to, e.g., continue their Medicaid. Moreover, many patients must recertify even though their medical or behavioral health care is covered by their Medicaid or other insurance, not by Ryan White — because Ryan White pays for a portion of some of the indirect services they receive such as appointments with insurance navigators or medical adherence nursing staff. This means that these patients are experiencing significant recertification burdens when they do not see the benefits they are receiving in return.

For all these reasons, we urge HAB to transition to annual rather than six-month recertification. This would substantially reduce burdens on clients, and free up staff time and resources to help eligible clients to fully access other benefits that may be available to them in their states.

Wisconsin HIV Primary Care Support Network, Milwaukee, WI

The Wisconsin HIV Primary Care Support Network respectfully requests that the Ryan White Program Client Eligibility Determinations and Recertification Requirement move to an annual recertification. (Reference RFI section C 3)

  • Staff perform a comprehensive annual assessment which includes obtaining appropriate release forms, insurance information, and verification of eligibility of services. This is documented in each client's medical record. Clinical staff work with clients closely throughout the year and identify when changes in income, insurance, or eligibility for services occur. While insurance HMOs change frequently and it is imperative to maintain updated information on this data point, changes in income or eligibility rarely occur. It is rare to have a client have such a significant change in income that they would be no longer eligible for services In fact, it has never happened to our clients.
  • The documentation for an every 6 month assessment that leads to very low change in eligibility is fairly significant and involves not only taking a client's time and energy to do the assessment, but the staff time for a client discussion, and then additional staff time required for maintaining the documentation. This is burdensome on everyone, from client to professional staff, to support staff.
  • Annual recertification would save staff time and resources, which can then be more effectively spent supporting patients with retention in care and treatment adherence with the goal of improved viral load suppression.

WV Bureau for Public Health, Charleston, WV

The requirement to re-certify eligibility every six months has been a time consuming and a burdensome policy to implement since the inception of the policy. While the state has achieved a high level of compliance with the policy throughout the years of implementation, it has been very time consuming for the medical case management, (MCM), staff. It has become increasingly difficult to comply since many physicians have adopted a policy of seeing their most stable patients just once per year, the opportunities to engage face to face with the clients at their medical appointments have dwindled. This has required much more follow up by the MCM. At times, the staff reports that they have spent up to a cumulative hour making requests to the client for supporting info to re-certify. Even self- attestations have required additional time to obtain and document. The end result, in almost all of the cases, is that the income of the client has not changed and valuable time that could have been spent with more pressing needs of clients has been utilized in complying with the policy. In addition, other services, such as oral health and nutritional support have had to be interrupted while awaiting recertification documents. The policy has also been a burden for the PLWHA who must comply with the recertification procedures. It requires a significant amount of time from staff assisting clients who are experiencing mental health and substance use issues; clients who are homeless are often more difficult to reach and frequently have no access to a phone. Many clients complain that they do not have access to a computer or a copier and others face significant travel burdens if they are attempting to meet with the MCM to meet this policy’s requirements. The states have the ability to closely monitor those clients who are nearing income limits and the foresight to conduct investigations into cases where information is questioned. Requiring every client to meet 6 month recertification lessens the time devoted to retention, linkage to care and to the delivery of quality services to the PLWHA in their jurisdictions.

Date Last Reviewed:  November 2018