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Rural Health Policy

Regulatory Review

The Federal Office of Rural Health Policy is charged in Section 1102(b) of the Social Security Act with advising the Secretary of the U.S. Department of Health and Human Services on the effect that federal health care policies and regulations may have on rural communities. Monitoring current and proposed changes, including programs established under titles XVIII and XIX (Medicare and Medicaid), FORHP analyzes their impact on the financial viability of small rural hospitals and clinics, on the ability of rural areas to attract health professionals, and on rural areas’ access to high quality care.

Data collection and analysis is essential to understanding the challenges in rural communities, how those communities are impacted by policy, and setting policy for the future. For this reason, the work of the Rural Health Research Centers informs that of FORHP’s policy team and vice versa.

Policy Updates 

December 17

Final Rule: 340B Drug Pricing Program; Administrative Dispute Resolution Regulation. The provisions of this final rule include a process to resolve (1) claims by covered entities that they have been overcharged for covered outpatient drugs by manufacturers and (2) claims by manufacturers, after the manufacturer has conducted an audit of a covered entity as authorized by section 340B(a)(5)(C) of the Public Health Service Act, that a covered entity has violated the prohibition on diversion or duplicate discounts.  HRSA will post the final rule on the 340B Drug Pricing Program website

Comments Requested: Proposed Changes to HIPAA Privacy Rule – 60 days from publication in the Federal Register. (PDF - 2.47 MB)  The Office for Civil Rights (OCR) at the Department of Health and Human Services (HHS) seeks comment on proposed changes to the use and disclosure of protected health information (PHI) in the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, which protects the privacy and security of individuals’ medical records and other PHI. 

December 10

CMS Final Medicare Outpatient Payment Rule.  Last week, the Centers for Medicare & Medicaid Services (CMS) finalized Medicare policies and payment updates for hospital outpatient departments and ambulatory surgical centers for calendar year 2021.  It continues past payment methods for participants of the 340B Drug Pricing Program, which allows hospitals and other providers to purchase certain covered outpatient drugs from manufacturers at discounted prices, revises the methods used to calculate the Overall Hospital Quality Star Rating, and includes Critical Access Hospitals and Veterans Health Administration Hospitals in the Star Ratings.

December 3

Medicare Physician Fee Schedule for 2021.  This week the Centers for Medicare & Medicaid Services (CMS) released the final policy, payment, and quality updates (PDF - 9.96 MB) for the Medicare Physician Fee Schedule, the Medicare Shared Savings Program, the Quality Payment Program, and the Diabetes Prevention Program for calendar year 2021.  In addition to payment updates,  it adds new services to the telehealth list, updates the scope of practice policies to allow teaching physicians to use interactive, real-time audio/video to interact with residents, and finalizes billing codes for Principal Care Management (PCM) services for Rural Health Clinics and Federally Qualified Health Centers.

Proposed Changes to Individual Insurance Market for 2022. (PDF - 40 KB)  Last week, the Centers for Medicare & Medicaid Services (CMS) released proposed regulations for states and health insurers planning on offering Qualified Health Plans (QHPs) through Federal and State Health Exchanges in 2022.  In addition to proposing new special enrollment periods and options for direct enrollment through private sector entities, this rule also proposes to make QHP Enrollee Experience Survey results publicly available in an annual public use file. 

Accountable Health Communities (AHC) Model – Two Rural Participants’ Experiences (PDF - 425.1 KB) HRSA Exit Disclaimer – This Rural Health Value HRSA Exit Disclaimer Rural Innovation Profile describes the successes and challenges of two AHCs serving rural populations.  The CMS Innovation Center Accountable Health Communities (AHC) Model seeks to identify and address health-related social needs of Medicare, Medicaid, and dual-eligible beneficiaries.

Waiver to Provide Acute Hospital Care At HomeThe Centers for Medicare & Medicaid Services (CMS) is accepting requests for hospitals to waive certain Medicare Conditions and Participation (CoPs) in order to provide acute care hospital services in a patient’s home. 

Stark Law and Anti-Kickback Statute Changes Finalized.  The Department of Health and Human Services (HHS) finalized changes to two rules that will allow healthcare providers to participate in care coordination activities and value-based arrangements without violating laws.  The first rule creates exceptions to the Physician Self-Referral law (aka the Stark Law), which prohibits a physician from referring a patient to any entity with which they have a financial relationship.  The second rule (PDF - 274 KB) adds safe harbors to the Anti-Kickback Statute, which imposes criminal penalties when someone solicits, pays, or receives a reward in exchange for referrals. 

November 19

Medicare Extreme and Uncontrollable Exceptions Applications – Due December 31.  The Centers for Medicare & Medicaid Services (CMS) is encouraging clinicians to submit an application now if there are concerns about the effect of COVID-19 on their performance data for the Quality Payment Program.  Learn more details about how the extreme and uncontrollable exception will change data reporting requirements. Clinicians should cite COVID-19 as the reason for the application.

Updated: Rural Crosswalk for COVID-19 Waivers and Flexibilities. (PDF - 1.84 MB) The Centers for Medicare & Medicaid Services (CMS) updated their summary of the COVID-19-related waivers and flexibilities that affect Rural Health Clinics, Federally Qualified Health Centers, Critical Access Hospitals, rural skilled nursing facilities, and rural hospitals to include those from the most recent Interim Final Rule with Comment (IFC)-4.

Updates to Medicare’s Online Compare Tool.  Starting December 1, Medicare.gov will compile the eight online tools to compare providers, such as Hospital Compare, Nursing Home Compare, and Physician Compare, into one place called Care Compare.  It provides the same information but with a new, streamlined design.  The Centers for Medicare & Medicaid Services urges providers to update hyperlinks on public-facing websites to the eight original care tools, so patients are directed to the new Care Compare.

November 12 

Final Medicaid and CHIP Managed Care Rule (PDF - 858 KB). This week, the Centers for Medicare & Medicaid Services (CMS) finalized revisions to the Medicaid and Children’s Health Insurance Program (CHIP) managed care regulations that were proposed in 2018.   The 2018 proposed rule and this final rule modifies several provisions from the 2016 managed care rule based on stakeholder feedback, including pass-through payments, network adequacy standards, and the Quality Rating System.  It also adds a provision allowing states to determine the most appropriate method to coordinate Medicare and Medicaid benefits for those that qualify for both.

Medicare Advanced Payment Model (APM) Changes for 2021 (PDF - 499 KB).  Under the Medicare Quality Payment Program (QPP), clinicians can participate in two tracks for payment purposes based on their practice size, specialty, location, or patient population: the Merit-based Incentive Payment System (MIPS) or an Alternative Payment Model (APM).  The criteria for clinicians to qualify as a participant in an APM are changing as of January 1, 2021, so the Centers for Medicare & Medicaid Services (CMS) developed a Quick Start Guide (PDF - 500 KB) and an Eligibility Decision Tree (PDF - 731 KB) to help clinicians determine if they qualify for an APM or if they will need to participate in MIPS in 2021. 

CMS Finalizes CY2021 End-Stage Renal Disease (ESRD) Rule.  This week, the Centers for Medicare & Medicaid Services (CMS) finalized Medicare payment policy updates for renal dialysis services provided to Medicare beneficiaries beginning January 1, 2021. The final rule includes an overall payment increase of 2.0 percent or $250 million for all ESRD facilities, while rural ESRD facilities are estimated to experience a 1.0 percent increase as a result of the proposed changes. Other policy changes include adoption of the 2018 OMB delineations, expansion of the list of new equipment and supplies, TPNIES, to include home dialysis machines, and updates to the low-volume payment adjustment due to the COVID-19 public health emergency.

Comments Requested: CMS Proposed Rule on Durable Medical Equipment – January 4. Last week, the Centers for Medicare & Medicaid Services (CMS) proposed policy changes for the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) fee schedule effective April 1, 2021, or the date immediately following the duration of the COVID-19 public health emergency.  Under the rule, CMS is proposing continuation of higher payment rates for items and services furnished in rural and non-contiguous areas, classifying all continuous glucose monitors as DME, and revisions to the application process for common procedure codes.

November 5

Comments Requested: Medicare Advantage Advance Notice Part II – November 30 (PDF - 1.64 MB).  Last week, the Centers for Medicare & Medicaid Services (CMS) released Part II of the Calendar Year 2022 Advance Notice of Methodological Changes for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies for public comment.  It includes estimates of changes in payments to MA plans and requests input on future quality measures and concepts for the MA and Prescription Drug plan Star Ratings system, which helps beneficiaries to compare plans.

New Toolkit for Long-term Services and Supports (PDF - 1.27 MB).  The Centers for Medicare & Medicaid Services (CMS) developed this toolkit to supporting states’ efforts to rebalance long-term services and supports (LTSS), so there is an equitable balance between services and supports delivered in home and community-based settings relative to institutional care.  The kit includes strategies to increase the share of LTSS provided in community-based settings; tools to assist with policy and programmatic changes; case studies of innovative programs; and links to relevant resources.

Final Rule on Price Transparency for Private InsuranceIn this final rule, the Department of Health and Human Services (HHS), the Department of Labor, and the Department of the Treasury are requiring individual and group health insurers, by 2023, to offer online tools for consumers to estimate how much they will have to pay out-of-pocket for health care items and services before receiving care.  The rule also requires that by 2022 insurers publically display their negotiated rates for in-network providers; their historical payments to out-of-network providers; and their in-network negotiated rates and historical net prices for prescription drugs.

CMS Finalizes CY2021 Payment Rules for Home Health. On November 4, CMS finalized Medicare payment policy updates for home health providers that are effective January 1, 2021. The rule includes an overall payment rate increase of $410 million that rural areas will experience as 1.5 percent greater than last year.  Other policy updates are related to rural add-on payments, remote patient monitoring, and the home infusion therapy benefit.  CMS finalized using the September 14, 2018 OMB Bulletin for delineations for Core-Based Statistical Areas (CBSAs), so several counties changed status as to whether they are rural or urban.  CMS included a transition period to mitigate any potential decreases in payments.

October 29

CMS Announces Fourth COVID-19 Interim Final Rule with Comment Period (PDF - 2.8 MB). On October 28, the Centers for Medicare & Medicaid Services (CMS) issued its fourth Interim Final Rule with Comment Period (IFC) in response to the COVID-19 Public Health Emergency (PHE). Highlights of interest to rural stakeholders in this rule include vaccine-related provisions; flexibilities for states maintaining Medicaid enrollment during the COVID‑19 PHE; enhanced Medicare payments for new COVID-19 treatments; and price transparency for COVID-19 tests. Comments will be due 60 days after the date of display in the Federal Register.

New CMS Rural Health Listserv HRSA Exit Disclaimer. The Centers for Medicare & Medicaid Services (CMS) has a new rural health care listserv dedicated to sharing information about programs, policies and resources. To subscribe to the new topic, click on the link above for CMS Email Updates, then look for Outreach and Education, then Rural Health. For more information on rural health activities at CMS, visit go.cms.gov/ruralhealth or contact RuralHealth@cms.hhs.gov.

Delayed Start Date for the Radiation Oncology Payment Model. In response to stakeholder feedback, the Centers for Medicare & Medicaid Services (CMS) is changing the start date of the Radiation Oncology Model to July 1, 2021, instead of January 1.  Participation in this model is required for all providers of radiotherapy treatment.  It creates a single, bundled payment system that is the same across providers, regardless of whether care occurs in an outpatient department or in a physician’s office.

CMS Releases Frequently Asked Questions for the CHART Model. Last week, CMS released a Frequently Asked Questions (FAQs) document addressing stakeholder questions regarding the Community Health Access and Rural Transformation (CHART) Model. The FAQs are posted on the CHART website.

October 22

Medicare Changes Payments for COVID-19 Lab Results.  Beginning January 1, 2021, the Centers for Medicare & Medicaid Services (CMS) will lower its base payment from $100 to $75 for COVID-19 diagnostic tests using certain highly sophisticated equipment called “high throughput technology.”  The change is explained in an amended Administrative Ruling, CMS 2020-1-R2. Labs that complete the test within two calendar days will receive a $25 add-on payment.

Updated Telehealth Resources for Medicare and MedicaidLast week, the Centers for Medicare & Medicaid Services (CMS) updated the “State Medicaid & CHIP Telehealth Toolkit: Policy Considerations for States Expanding Use of Telehealth, COVID-19 Version,” originally released in April 2020.  It has new examples and insights into lessons learned from states that have implemented telehealth changes.  The Medicaid and CHIP data snapshot (PDF - 313 KB) illustrates the rate of telehealth use across the states during the public health emergency.  CMS also updated the list of Medicare services that can be provided via telehealth during the COVID-19 public health emergency.

October 15

Updated Medicare COVID-19 Data Snapshot (PDF - 325 KB). This factsheet reports COVID-19 cases, hospitalizations, and services used by Medicare beneficiaries between January 1 and August 15.  In rural areas, there were 959 cases per 100,000 Medicare beneficiaries during this time and 252 hospitalizations per 100,000 beneficiaries.

New CMS Guidance on Repayment Terms for Medicare Accelerated and Advance Payments (PDF - 71 KB).  Last week, the Centers for Medicare & Medicaid Services (CMS) updated the repayment terms for providers and suppliers who received accelerated and advance Medicare payment(s) during the COVID-19 emergency to reflect that repayment does not begin for one year after payment was issued.  Providers experiencing financial hardship should contact their Medicare Administrative Contractor to request an Extended Repayment Schedule.

New Website on Hospital Price Transparency. Last week, CMS announced a website to assist hospitals with meeting the requirements of the FY2020 Price Transparency Rule (PDF 790 KB).  By January 1, 2021, all hospitals, including rural and Critical Access Hospitals (CAHs),  must provide clear, accessible pricing information online about the items and services they provide.  This information must include a machine-readable file with all items and services as well as a display of shoppable services in a consumer-friendly format.

Preliminary Findings on the CMS Accountable Health Communities ModelCMS announced that, through the Accountable Health Communities (AHC) model, 750,000 screenings have been completed to identify and address health related social needs (HRSN) for eligible Medicare and Medicaid beneficiaries.  The AHC model operates in 21 states and tests the impact of screenings for HRSN and referrals to community resources on health care costs and health care utilization in rural and urban communities.  Of the screenings completed, one-third reported at least one HRSN with food being the most prominent need.

October 8

Nominations: NQF Rural Telehealth Committee HRSA Exit Disclaimer – October 26.  The National Quality Forum (NQF) is a nonpartisan, not-for-profit organization that determines measures and standards of quality for safe health care with better outcomes.  The NQF’s Rural Telehealth and Healthcare System Readiness Committee will work on a 14-month project funded by the U.S. Department of Health & Human Services, researching current health-system readiness for pandemics, disaster events, and other public health emergencies, and exploring what’s required to implement telehealth in rural areas.

Critical Access Hospital (CAH) Meaningful Use Hardship Exception Applications HRSA Exit Disclaimer – November 30.   The Centers for Medicare & Medicaid Services (CMS) requires that all CAHs use 2015 Edition certified electronic health record technology (CEHRT) to meet the requirements of the Promoting Interoperability Programs. If a CAH can provide proof that meeting this requirement results in a significant hardship, they can apply for a hardship exception, which is valid for only one payment adjustment year. CAHs that do not meet the requirement and do not get a hardship exception will have a downward payment adjustment.

Comments Requested: Proposed DATA 2000 Training Payment Application – December 7.  HRSA will soon be able to reimburse Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs) for the average training costs of eligible physicians and practitioners to obtain Drug Addiction Treatment Act of 2000 (DATA 2000) waivers. These waivers allow eligible physicians to treat opioid dependency in settings other than opioid treatment programs (OTPs).  FQHCs and RHCs are encouraged to provide comments on whether the proposed application collects necessary and useful information, if HRSA accurately estimated the burden of completing the application, and how the application could be improved.

Guidance on Hospital COVID-19 Data Reporting and Enforcement (PDF - 170 KB).  This week, the Centers for Medicare & Medicaid Services (CMS) released the requirements and enforcement process for all Medicare and Medicaid hospitals and Critical Access Hospitals (CAHs) to report COVID-19 data.  Hospitals and CAHs must report daily to the federal government or to their state if they receive a written release from the state.  Failure to do so will result in a series of enforcements actions over several weeks that could result in termination of the Medicare provider agreement.  Separate guidance provides the definitions of the data elements for hospitals and in-hospital labs.  

October 1

Quick Start Guide for Labs to Become Medicare-Certified (PDF - 1.97 MB).  For laboratories seeking Medicare Clinical Laboratory Improvement Amendments (CLIA) certification to test for COVID-19, CMS released a guide last week to help with the application process and the expedited review process, including how to submit the form to the correct state agency (PDF - 71 KB).  Under the public health emergency, labs have the option to pay CLIA certification fees on the CMS CLIA Program website, and they can start COVID-19 testing before the official paper certificate arrives by postal mail. 

Reporting Requirements for Provider Relief Funds (PDF - 262 KB). This guidance, released last week, informs Provider Relief Fund (PRF) recipients who received payments exceeding $10,000 of the data elements that they must report for calendar years 2019 and 2020 as part of their terms and conditions.  It provides detail on how to report expenses attributable to COVID-19, including general and administrative, health care related, and lost revenue.

Medicare Ambulance Payment Model to Expand Nationwide.  Last week, the Centers for Medicare & Medicaid Services (CMS) announced that it will expand the Medicare Prior Authorization Model for Repetitive, Scheduled Non-Emergent Ambulance Transport (RSNAT) nationwide.  This model allows for certain Medicare beneficiaries to ride in ambulances to certain medical appointments, most often for dialysis treatment, when the service is approved in advance. The evaluation found that the model reduces Medicare spending without changing quality or access to care in both rural and non-rural areas.

Date Last Reviewed:  December 2020


Reports

Guide for Rural Health Care Collaboration and Coordination (2019) (PDF - 2 MB) This Guide describes how rural hospitals, community health centers, local public health departments, and other rural stakeholders can work together to assess and address their rural communities’ health needs. 

Interim Report to Congress on Frontier Health Demonstration Project (2018) (PDF - 565 KB)

Final Report to Congress on Frontier Health Demonstration Project (2020) (PDF - 345 KB) This final Report to Congress expands on the interim report, with findings from the duration of the 3-year model and recommendations for legislative and administrative action.

Note: Persons using assistive technology may not be able to fully access information in this file. For assistance, please email Kerri Cornejo or call (301) 443-4204.

Questions about Policy Updates?