Public Comments - Cover Letters/General Comments

AIDS United, Washington, DC

You will find a collection of comments on HRSA's Administrative Streamlining and Burden Reduction Request For Information from various members of AIDS United Public Policy Council (PPC). The AIDS United PPC members who have submitted comments for this RFI constitute a broad cross-section of the HIV service provider community, with a good deal of geographic, demographic, and institutional diversity represented in their remarks and their experiences. In addition to the comments from Legacy Community Health, AIDS Resource Center Wisconsin, APLA Health and Equitas Health, we have included a sign-on list of other AIDS United PPC member organizations who would also like to express their support for recommendations made in this document.

  • AIDS Alabama
  • AIDS Foundation of Chicago
  • AIDS Resource Center Wisconsin
  • Amida Care
  • APLA Health
  • Cascade AIDS Project
  • CrescentCare
  • Equitas Health
  • GMHC
  • Harm Reduction Coalition
  • Housing Works
  • JustUs Health
  • Latino Commission on AIDS
  • Legacy Community Health
  • Los Angeles LGBT Center
  • Project Inform
  • Puerto Rico CoNCRA
  • Southern AIDS Coalition
  • Southern HIV/AIDS Strategy Initiative
  • Treatment Action Group

ALTURA Centers for Health, Tulare, CA

Altura Centers for Health (ALTURA) appreciates the opportunity to comment on the Health Resources and Services Administration (HRSA) Administrative Streamlining and Burden Reduction RFT (RFI). ALTURA is a federally qualified health center (FQHC) serving over 27,000 patients in Tulare and surrounding rural communities. We have been a designated FQHC for 20 years. Our long history as a HRSA grantee under these programs makes us uniquely qualified to weigh in on this RFI.

American Association of Nurse Practitioners, Alexandria, VA

The American Association of Nurse Practitioners (AANP), representing more than 248,000 nurse practitioners (NPs) in the United States, appreciates the opportunity to provide comment in response to the Request for Information (RFI) on Administrative Streamlining and Burden Reduction.

NPs are advanced practice registered nurses who are prepared at the masters or doctoral level to provide primary, acute, chronic and specialty care to patients of all ages and walks of life. Daily practice includes: assessment; ordering, performing, supervising and interpreting diagnostic and laboratory tests; making diagnoses; initiating and managing treatment including prescribing medication and non-pharmacologic treatments; coordinating care; counseling; and educating patients and their families and communities. NPs practice in nearly every health care setting including clinics, hospitals, Veterans Affairs and Indian Health Care facilities, emergency rooms, urgent care sites, private physician or NP practices (both managed and owned by NPs), nursing homes, schools, colleges, retail clinics, public health departments, nurse managed clinics, homeless clinics, and home health. NPs hold prescriptive authority in all 50 states and the District of Columbia. It is important to note that 86.6% of NPs are certified in primary care, the majority of whom see Medicare and Medicaid patients. NPs complete more than one billion patient visits annually. Below are our responses to the RFI, and we look forward to working with you on these initiatives.

American Optometric Association, Alexandria, VA

The American Optometric Association (AOA) appreciates the opportunity to provide these comments in response to the Health Resources and Services Administration request for information on "Administrative Streamlining and Burden Reduction."

The AOA represents approximately 33,000 doctors of optometry and optometry students. Doctors of optometry are eye and vision care professionals who diagnose, treat and manage diseases, injuries and disorders of the eye, surrounding tissues and visual system and play a major role in a patient’s overall health and well-being by detecting and helping to prevent complications of systemic diseases such as hypertension, cardiovascular disease, neurologic disease, and diabetes - the leading cause of acquired blindness. Doctors of optometry serve patients in 10,176 communities across the country, and are the only eye doctors available in 3,500 of those communities. Providing more than two-thirds of all primary eye and vision health care in the United States, doctors of optometry deliver up to 80 percent of all primary vision and eye health care provided through Medicaid. Recognized as Medicare physicians for more than 25 years, doctors of optometry provide medical eye care to nearly six million Medicare beneficiaries annually. These valued primary care providers are an important access point to the health care system for many patients.

Bi-State Primary Care Association, Montpelier, VT

Established in 1986, Bi-State Primary Care Association (Bi-State) is a nonpartisan, nonprofit 501(c)(3) charitable organization promoting access to effective and affordable primary care and preventive services for all, with special emphasis on underserved populations in Vermont and New Hampshire. Bi-State’s combined Vermont and New Hampshire membership includes 22 Federally Qualified Health Centers (FQHCs), delivering primary care to over 260,000 patients.

Bi-State appreciates this opportunity to provide comments regarding Administrative Streamlining and Burden Reduction (RFI released 5/1/18). Bi-State has held and currently holds multiple HRSA grants (including those from BPHC, ORHP, and MCH) in addition to our Primary Care Association Cooperative Agreement. Bi-State additionally has gathered feedback from its twenty-two FQHCs and Look-Alikes in Vermont and New Hampshire and includes their input in this comment submission.

California Primary Care Association, Sacramento, CA

The California Primary Care Association (CPCA) appreciates the opportunity to comment on the Health Resources and Services Administration (HRSA) Administrative Streamlining and Burden Reduction RFI (RFI). CPCA represents more than 1,300 community clinic and health center (CCHC) sites in California that provide services to 6.5 million Medi-Cal beneficiaries.

CCHCs provide care to about one out of every six Californians. A fundamental characteristic of CCHCs is their commitment to serve all individuals, regardless of ability to pay. For this reason, a majority of CCHCs are designated as Federally Qualified Health Centers (FQHCs) and many participate in HRSA-administered programs considered in this RFI, including the Ryan White HIV/AIDS Program (RWHAP), programs administered by the Bureau of Healthcare Workforce (BHW), and many other grant programs overseen by HRSA’s Office of Federal Assistance Management (OFAM). Participating in such a wide array of HRSA-run programs makes California's CCHCs uniquely qualified to weigh in on this RFI.

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

The Community Clinic Association of Los Angeles County (CCALAC) appreciates the opportunity to comment on the Health Resources and Services Administration (HRSA) Administrative Streamlining and Burden Reduction Request for Information (RFI). CCALAC is a Section 501(c)(3) tax-exempt organization representing 64 nonprofit community clinics and health centers (members) that operate more than 350 sites throughout Los Angeles County and serve more than 1.5 million low-income, uninsured and underserved individuals each year.

A majority of CCALAC's members are designated as Federally Qualified Health Centers (FQHCs) and many participate in the HRSA-administered programs considered in this RFI, including the Ryan White HIV/AIDS Program (RWHAP), programs administered by the Bureau of Healthcare Workforce (BHW), and other grant programs overseen by HRSA's Office of Federal Assistance Management (OFAM).

Participating in a wide array ofHRSA-run programs makes community clinics and health centers uniquely qualified to weigh in on this RFI.

Community Health Systems, Inc., Moreno Valley, CA

Community Health Systems, Inc. (CHSI) appreciates the opportunity to comment on the Health Resources and Services Administration (HRSA) Administrative Streamlining and Burden Reduction RFI (RFI). Community Health Systems, Inc. (CHSI) is a federally qualified health center (FQHC) serving more than 27,000 patients in San Bernardino, Riverside, and North Inland San Diego Counties. We have been a designated FQHC for more than 25 years, and have also received Section 330(e) funding from HRSA. Our long history as a HRSA grantee under these programs makes us uniquely qualified to weigh in on this RFI.

Eastern Aleutian Tribes, Anchorage, AK

HRSA should work with other federal agencies, like Indian Health Service and CMS, to streamline the GPRA and performance measures that health centers are required to report on. Alaska Native Tribal Health Consortium has created a document with all three requirements on one document that demonstrates how close some of the measures are to each other. Revising a few performance measures to be the same as what other federal agencies require would greatly reduce our reporting burden.

Family Health Centers of San Diego, San Diego, CA

Family Health Centers of San Diego appreciates the opportunity to comment on the Health Resources and Services Administration (HRSA) Administrative Streamlining and Burden Reduction RFI (RFI). Family Health Centers of San Diego is one of the ten largest federally qualified health centers (FQHCs) in the nation, serving 137,937 unique patients in 2017 across San Diego County. Our long history as a HRSA grantee and a national leader in community medicine makes us uniquely qualified to provide our comments on proposed streamlining and burden reduction.

Health Center Partners of Southern California, San Diego, CA

Health Center Partners of Southern California appreciates the opportunity to comment on the Health Resources and Services Administration (HRSA) Administrative Streamlining and Burden Reduction RFI (RFI). Health Center Partners of Southern California is a voluntary association of seventeen primary care medical providers (12 are FQHC) serving more than 860,000 patients in San Diego, Imperial and Riverside counties of southern California. We have been a designated a health center-controlled network (HCCN) for six years through HRSA. Our long history as a HRSA grantee under these programs make us uniquely qualified to weigh in on this RFI.

Legacy Community Health, Houston, TX

On behalf of Legacy Community Health, we appreciate the opportunity to respond to Health Resources and Services Administration’s (HRSA) Request for Information (RFI) regarding changes to regulations or guidance that could reduce burden and increase efficiencies for grant recipients and other stakeholders.

As a full-service, Federally Qualified Health Center (FQHC) and Ryan White grantee based in Houston, Texas, Legacy identifies unmet needs and gaps in health-related services and develops client-centered programs to address those needs. A United Way-affiliated agency since 1990, Legacy currently provides adult primary care, pediatrics care, dental care, vision services, behavioral health services, OB/GYN and maternity services, vaccinations and immunizations, health promotion and community outreach, wellness and nutrition information and comprehensive HIV/AIDS care.

With over thirty locations across Southeast Texas, Legacy is truly on the front lines of treating patients seeking high-quality, integrated care. As a recipient of the Ryan White grant since the program’s inception, we are an active stakeholder in bettering the program, and we encourage HRSA to remove any unnecessary restrictions that limit access to care for some of the nation’s most vulnerable patient populations.

Mendocino Community Health Clinic, Ukiah, CA

Mendocino Community Health Clinic (MCHC) appreciates the opportunity to comment on the Health Resources and Services Administration (HRSA) Administrative Streamlining and Burden Reduction RFI (RFI). MCHC is a federally qualified health center (FQHC) serving 32,000 patients in rural Mendocino and Lake County, California. We have been a designated FQHC for 25 years, and also receive Healthcare for the Homeless and Agricultural Health Center funding from HRSA. Our long history as a HRSA grantee under these programs makes us uniquely qualified to weigh in on this RFI.

National Association of Community Health Centers, Washington, DC

The National Association of Community Health Centers (NACHC) is pleased to respond to HRSA's Request for Information on Administrative Streamlining and Burden Reduction, released on May 1, 2018. As you are aware, NACHC is the national membership organization for HRSA's Health Centers. With almost 1,400 grantee organizations and over 10,000 sites, HRSA's Health Centers — which include Community Health Centers, Migrant Health Centers, Health Care for the Homeless Grantees, and Public Housing Primary Care Grantees — all work to provide affordable access to 26 million medically vulnerable individuals across the nation.

NACHC supports HRSA's efforts to actively reduce public and stakeholder burden in complying with administrative and reporting requirements, and welcomes this opportunity to provide input. We begin with a summary of our comments, and then discuss each individually.

Neighborhood Healthcare, Escondido, CA

Neighborhood Healthcare appreciates the opportunity to comment on the Health Resources and Services Administration (HRSA) Administrative Streamlining and Burden Reduction RFI (RFI). Neighborhood Healthcare is a federally qualified health center (FQHC) serving 65,399 patients in San Diego and Riverside Counties. We have been a designated FQHC for 45 years, and receives funding under Section 330 of the Public Health Service Act as a designated Community Health Center from HRSA. Our long history as a HRSA grantee under these programs make us uniquely qualified to weigh in on this RFI.

OCHIN, Portland, OR

On the behalf of OCHIN, we appreciate the opportunity to comment on the “Administrative Streamlining and Burden Reduction RFI” due July 2, 2018. The Department’s efforts to improve interoperability and reduce administrative burden runs parallel to OCHIN’s goals and has widespread impact on our national healthcare system.

OCHIN is a 501(c)(3) nonprofit community-based health information technology (HIT) collaborative based in Portland, Oregon. OCHIN receives support from the U.S. Department of Health and Human Services Administration (HRSA), and is a HRSA-designated Health Center-Controlled Network (HCCN). OCHIN’s mission is to pioneer the use of health information technology (HIT) in caring for the medically underserved touching over 500 clinics across the U.S. OCHIN serves community health centers (CHCs), including Federally Qualified Health Centers (FQHCs), rural and school-based health centers, safety-net providers and public health and corrections facilities across the nation. OCHIN’s comments are based on our experiences with the community health centers we serve.

OCHIN strongly supports interoperability to promote healthcare information exchange for the benefit of both patients and providers. An all-inclusive interoperability system provides for timely, secure, and trusted bidirectional exchange of pertinent healthcare information with affiliated and unaffiliated health care providers, and with disparate electronic health record (EHR) technology and vendors.

Papa Ola Lokahi (POL), Honolulu, HI

Papa Ola Lokahi (POL) is deeply and solely committed to raising the health status of Native Hawaiians and their families to the highest possible levels, which is why we appreciate the opportunity to comment on RFI sections A.I and A.3.

POL strives to accomplish its miss ion through work related to policy, research, collecting and disseminating data and information, protecting and perpetuating traditional Hawaiian healing practices, health education and wellness promotion. In addition, we provide administrative oversight and technical assistance to the five Native Hawaiian Health Care Systems (NHHCS) as it relates to funding received under the Native Hawaiian Health Program so they may better focus on the needs of their unique and individual communities by providing primary and behavioral health care and enabling services throughout the islands.

With the highest racial minority population in the United States, the State of Hawai'i plays host to a myriad of disparities that for many Native Hawaiians have been reality for generations. For over 20 years NHHCSs have helped to reveal gaps in the community's needs, some of which concealed behind government and organizational bureaucracy, invisible to policymakers, leaving needs of the most vulnerable individuals unmet.

Premier, Inc., Charlotte, NC

Thank you for the opportunity to respond to the above-captioned request for information (RFI) on administrative streamlining and burden reduction. Premier, Inc. appreciates the Health Resources and Services Administration's (HRSA's) efforts to reduce administrative burden in its programs. We are writing in response to Provision B, HRSA's Healthcare Systems Bureau (HSB). One program under HSB that could benefit from streamlining and reduction of burden is the 340B Drug Pricing Program. We are particularly concerned about HRSA's implementation of the GPO exclusion in the 340B through the agency's implementation of Policy Release 2013-1.

Premier, Inc. represents an alliance serving approximately 3,900 leading hospitals and health systems, hundreds of thousands of clinicians and 150,000 other provider organizations. Premier healthcare alliance, a 2006 Malcolm Baldrige National Quality Award recipient, plays a critical role in the rapidly evolving healthcare industry, collaborating with members to co-develop long-term innovations that reinvent and improve the way care is delivered to patients nationwide. Our comments primarily reflect the concerns of our owner hospitals and health systems which, as service providers, have a vested interest in the effective operation of the 340B program.

We respectfully request that HRSA rescind Policy Release 2013-1. The Policy Release has increased the regulatory and compliance costs as well as increased the costs of products for Premier member hospitals.

For 21 years (1992 to 2013) the 340B program ran effectively. Under that model, hospitals maintained a 2 inventory system. All initial purchases were through GPOs and replenished with either a GPO or 340B drug depending on the patient's eligibility. Policy Release 2013-1 forbade hospitals from making initial purchases through a GPO account, forcing them instead to buy their initial inventories at a non-GPO, non-340B price. The practical effect of the Policy Release was that hospitals had to start maintaining 3 inventories: 1) a 340B inventory for drugs that qualify as "covered outpatient drugs" and are dispensed or administered to 340B-eligible patients; 2) a GPO inventory for inpatient drugs or drugs that don't otherwise qualify as "covered outpatient drugs"; and 3) a non-GPO, non-340B inventory for initial purchases and when a "covered outpatient drug" can't be replenished with a 340B drug.

Today, when a hospital participating in the Prime Vendor program makes its initial purchases through a non-GPO, non-340B account, the Prime Vendor's sub-WAC price file is automatically loaded into that account. Those drugs are then replenished with 340B drugs when used as "covered outpatient drugs" for 340B-eligible patients, with GPO drugs when used for purposes outside the "covered outpatient drug" definition and with non-GPO, non-340B drugs for anything else.

The 3-inventory model is not required by statute, which states that hospitals may not "obtain" covered outpatient drugs through a GPO. A drug only becomes a "covered outpatient drug" once it is furnished to a patient and billed to a payer. Before that, it is simply a drug with no inpatient or outpatient status. The purchase of the covered outpatient drug comes after the fact when the drug is replenished. Moreover, a drug's purchase price is typically not final until after the manufacturer has settled up with the wholesaler through the chargeback process – which can take days, even weeks, to complete – making HRSA’s initial-purchase-at-WAC requirement an illusory concept. The Supreme Court in Abbott Laboratories v. Portland Retail Druggists, 425 U.S. 1 (1976), recommended a 2-inventory system for a similar GPO exclusion.

Implications:

The 3-inventory system is burdensome to operate and has increased operating costs. It imposes substantial labor and software costs on hospitals. One analysis estimates that the policy has raised costs by $223,000,000 since its inception.

The 3-inventory system also increases drug costs through unnecessary sub-WAC purchases. Complexities of 3-inventory system may cause many hospitals unnecessarily to purchase drugs eligible for GPO discounts or 340B pricing through the higher priced sub-WAC account. Comparisons between GPO and the Prime Vendor’s sub-WAC file prices show that the sub-WAC file is substantially more expensive. A 2015 survey showed that approximately 90% of respondents affected by the 2013 policy reported increased spending on their non-GPO, non-340B accounts.

Finally, the 3-inventory system puts hospitals at risk of being terminated from the 340B program or making significant repayments to manufacturers by using a single GPO drug on a hospital outpatient, even if unintended.

Because of the cost, regulatory and compliance requirements of the current policy governing the GPO prohibition, we urge HRSA to rescind Policy Release 2013-1.

QueensCare Health Centers, Los Angeles, CA

QueensCare Health Centers (QHC) appreciates the opportunity to comment on the Health Resources and Services Administration (HRSA) Administrative Streamlining and Burden Reduction Request for Information (RFI). As a Federally Qualified Health Center (FQHC), QHC is serving nearly 25,000 patients throughout its five clinics (Bresee (all pediatric), Eagle Rock, East 3rd Street, Echo Park and Hollywood) located in Los Angeles County. In 2017, QHC earned the distinction of being renewed by the National Committee on Quality Assurance (NCQA) as a Patient-Centered Medical Home (PCMH),Level 3; and was also the recipient of a 2017 Health Center Patient-Centered Medical Home (PCMH) Recognition Quality Award from HRSA.

Our long history as a HRSA grantee under some of HRSA-administered programs make us uniquely qualified to weigh in on this RFI.

Whitman-Walker Health, Washington, DC

Whitman-Walker Health (WWH or Whitman-Walker) is pleased to submit these comments in response to HRSA's May 1, 2018, Request for Information: Administrative Streamlining and Burden Reduction. We support HRSA’s efforts to identify and reduce inefficient and unnecessary administrative burdens in order to increase the effectiveness of the Ryan White Program and other HRSA-administered public health programs and ensure maximum benefits for the low-income people living with HIV or other serious medical conditions, or in need of primary care.

Interest of Whitman-Walker Health

Whitman-Walker is a Federally Qualified Health Center serving greater Washington, DC's diverse urban community, including individuals who face barriers to accessing care, and with a special expertise in HIV care and serving lesbian, gay, bisexual, transgender and questioning/queer (LGBTQ) populations. We empower all persons to live healthy, love openly, and achieve equality and inclusion. Our health center provides high quality, affirming health care to more than 20,000 individuals annually and is the medical home to more than 10,000 patients. The center has five sites and a team of more than 280 highly educated and practically experienced staff.

WWH services include primary medical care, HIV and LGBTQ specialty care, oral health, mental health care, addictions treatment services, psychosocial support, medical nutrition therapy, early intervention services, public benefits and insurance navigation, nursefocused case management, HIV and STI screening, legal services, youth programs, and an onsite pharmacy. The health center has achieved Level 3 Patient Centered Medical Home accreditation with the National Committee for Quality Assurance.

A programmatic innovation, which was a major success and led to changes in the regional provision of immediate HIV care, is our Red Carpet initiative. This program ensures that individuals newly diagnosed with HIV, or HIV-positive and new to care at Whitman- Walker, receive immediate services at any WWH site. Clients receive an evaluation of emotional, social, psychological and physical needs and public benefits and health insurance needs to ensure all programs and assistance to reduce cost of care are accessed.

WWH began in November 1973 in a church basement as the Gay Men's VD Clinic. Officially chartered in 1978, Whitman-Walker Clinic, Inc. took the lead as the HIV/AIDS epidemic developed. As the organization grew, goals broadened beyond HIV until WWH matured into the full-service health care center that exists today. To better reflect our broad mission, the organization began doing business as Whitman-Walker Health in 2011.

WWH has received Ryan White funding since the inception of the grant program in 1990. WWH’s service area is the greater Washington, DC metropolitan area; we serve more than 20% of the District of Columbia’s reported HIV-positive population, many of them lowincome or members of otherwise underserved communities. Our patient populations include: African Americans; Hispanic individuals; men who have sex with men (MSM); substance users; low income and homeless individuals; and transgender persons. Of DC’s reported Ryan White patients, WWH serves 30% and diagnosed 30% of the new HIV cases in 2016 via a robust HIV testing program.

Date Last Reviewed:  August 2018