The following is the latest health policy news from the federal government as of 2:30 p.m. on Thursday, March 10. Some of the language used below is taken directly from government documents.
- The White House has posted a transcript of the March 2 press briefing given by its COVID-19 response team to outline the administration’s National COVID-19 Preparedness Plan.
340B Eligibility Protection and Telehealth Extensions in the Omnibus Spending Bill
Providers that feared they might lose their eligibility to continue participating in the 340B prescription drug discount program because they have fallen below that program’s Medicare disproportionate share (Medicare DSH) threshold will remain eligible for the program at least through their next reporting period.
The following is a summary of the telehealth flexibilities extensions included in this bill, which passed in the House yesterday and is expected to pass in the Senate this weekend.
- Patients will be permitted to continue receiving telehealth services at any site at which they are located, including their homes, for 151 days beginning on the first day after the public health emergency (PHE) formally ends.
- This applies to all services that are considered payable under the Medicare physician fee schedule at the time of enactment and as provided for in the Medicare list of telehealth services found here.
- During this 151-day extension period CMS must continue to provide coverage and payment for audio-only telehealth services that it has permitted during the PHE.
- During the extension period, CMS will permit qualified occupational therapists, physical therapists, speech-language pathologists, and audiologists to furnish telehealth services.
- All telehealth flexibilities and related payment policies in place during the PHE for federally qualified health centers (FQHCs) and rural health clinics (RHCs) will continue during the 151-day extension period.
- The bill delays for 151 days a provision of the Consolidated Appropriations Act of 2021 that would have required patients that receive post-PHE telehealth services for the diagnosis, evaluation, or treatment of a mental health disorder to have an in-person physician visit every six months.
- Likewise, periodic in-person physician visit requirements for hospice patients receiving virtual mental health visits from an FQHC or RHC will not apply during the extension period.
- The option for a hospice physician or nurse practitioner to conduct a face-to-face encounter via telehealth will remain during the extension period.
- Certain IRS flexibilities that protect high-deductible health plans from losing their status for failing to have a deductible for telehealth and other remote care services will be continued during the extension period.
- HHS is authorized to implement the provisions of this legislation through program instructions rather than full notice-and-comment rule-making.
It is yet unclear whether CMS will continue to pay providers an originating site facility fee for telehealth services at sites that did not qualify to receive this fee prior to implementation of the COVID-19 PHE flexibilities. It appears the legislation is attempting to restrict payment of the facility fee to “new sites” but stakeholders are seeking clarification on whether this prevents non-rural originating site hospitals and physician offices from billing for the facility fee as they have done during the pandemic.
The bill directs MedPAC to study the effects of the telehealth waivers made available during the COVID-19 PHE and during the extension period and to report its findings to Congress by June 15, 2023. That analysis shall include information on utilization, the provision of telehealth services by clinicians located in different states than the beneficiary receiving the service, beneficiary types, Medicare expenditures, payment policies and potential alternatives, and the implications of this expansion for access to care and quality of care. Part of this process will include quarterly publication of utilization and beneficiary characteristics data beginning on July 1, 2022.
The bill also directs HHS’s Office of Inspector General to report to Congress by June 15, 2023 on the program integrity risks associated with Medicare telehealth services, including recommendations to prevent waste, fraud, and abuse.
Centers for Medicare & Medicaid Services
- CMS has issued guidance to state Medicaid programs to ensure that they are prepared to initiate eligibility renewals for all individuals enrolled in Medicaid and CHIP within 12 months of the eventual end of the public health emergency and to complete renewals within 14 months. To help consumers maintain coverage, the guidance emphasizes current rules requiring states to provide a smooth transition to other options for those who may no longer be eligible for Medicaid or CHIP. This letter is part of a series of guidance and tools that outline how states may address the large volume of pending eligibility and enrollment actions that will need to be addressed when they restore routine operations, including terminations of coverage. It describes how states may distribute eligibility and enrollment work in the post-public health emergency period, mitigate churn for eligible beneficiaries who lose coverage and later reenroll, and smoothly transition individuals between coverage programs. It reiterates options for states to align work on pending eligibility and enrollment actions after the public health emergency ends and provides that states must initiate, rather than complete, all pending actions during the 12-month unwinding period. In addition, it informs states that they are at risk of inappropriately terminating coverage for eligible individuals if they plan to initiate a high volume of renewals in a given month and that CMS intends to collect information on all states’ plans to adopt strategies that will promote continuity of coverage and guard against inappropriate terminations. Learn more from this CMS letter to state Medicaid officials.
- CMS has updated its FAQ about whether the use of over-the-counter tests authorized by the FDA intended for home use require CLIA certification and whether facilities that administer over-the-counter COVID-19 tests require CLIA certification. Find that information here.
Health Policy Update
- CMS has posted a new edition of MLN Connects, its online publication with information about Medicare payment issues. The latest edition includes a notice of revised emergency use authorization for one of the monoclonal antibodies used to treat COVID-19; direct graduate medical education resets for teaching hospitals; reissued preview reports for LTCHs and IRFs; and more. Find these items and others in the latest edition of MLN Connects.
Department of Health and Human Services
- HHS announced that the administration has launched a nation-wide “test-to-treat” approach to ensure rapid access to COVID-19 treatments. Through this program, people who test positive for COVID-19 will be able to visit hundreds of local pharmacy-based clinics and federally qualified community health centers (FHQCs) and will, in one stop, be assessed by a qualified health care provider who can prescribe antiviral pills on the spot; the same will be true for residents of long-term-care facilities. This will ensure that if people who are at high risk for developing severe COVID-19 test positive and if administration of an antiviral is appropriate, they can get treatment quickly and easily. The program includes a direct allocation of antiviral pills to participating clinics, centers, and facilities. Learn more about this program from this HHS news release and an accompanying fact sheet.
- HHS and the Office of the Surgeon General have issued a request for information seeking input from interested parties on the impact and prevalence of health misinformation in the digital information environment during the COVID-19 pandemic. Learn more about the request for information in this Federal Register notice. Comments are due by May 2.
Health Policy Update
- HHS and its Substance Abuse and Mental Health Services Administration (SAMHSA) and Office of Minority Health have announced nearly $35 million in funding opportunities to strengthen and expand community mental health services and suicide prevention programs for America’s children and young adults. The initiative consists of seven distinct funding programs with their own objectives, requirements, funding limits, and potential grant amounts and with due dates ranging from April 18 to May 2. Learn more about the overall initiative and find descriptions of each program and links to more detailed information about the individual funding opportunities and eligibility in this HHS news release.
Centers for Disease Control and Prevention
- The CDC has updated its guidance for administering tests for the diagnosis of COVID-19. The updated guidance addresses when to consider confirmatory testing in symptomatic and asymptomatic individuals; removes general guidance for congregate settings; adds links to setting-specific guidance; removes general guidance for processing and handling COVID-19 clinical specimens; and adds links to guidance on quality assurance procedures. Find the updated guidance here.
- The CDC is seeking nominations for membership on the Advisory Committee to the Director, Health Equity Workgroup. The work group will consist of approximately 15 members who are experts in fields associated with health equity; public health science and practice; public health policy development, analysis, and implementation. Learn more about the committee and its work in this Federal Register notice. Nominations are due by March 17.
Occupational Safety and Health Administration (OSHA)
- OSHA has directed its regional offices to engage in a highly focused, short-term inspection initiative directed at hospitals and skilled nursing care facilities that treat or handle COVID-19 patients. Through this initiative, OSHA will assess employer compliance efforts, including the readiness of hospitals and skilled nursing care employers to address any ongoing or future COVID-19 surges, by focusing on follow-up and monitoring inspections of hospitals and skilled nursing care facilities that OSHA had previously inspected or investigated. The intent of this initiative is to magnify OSHA’s presence in high-hazard health care facilities over a three-month period (March 9, 2022 to June 9, 2022) and to encourage employers in these sectors to take the necessary steps to protect their workers against the hazards of COVID-19. Learn more about OSHA’s intentions and how it intends to conduct these inspections in this memo to OSHA’s regional offices.
National Institutes of Health
- NIH researchers are conducting a clinical trial designed to help understand rare but potentially serious systemic allergic reactions to COVID-19 mRNA vaccines. Learn more from this NIH news release.
Medicare Payment Advisory Commission (MedPAC)
- MedPAC has submitted formal comments to CMS in response to that agency’s notice of proposed rulemaking titled “Advance Notice of Methodological Changes for Calendar Year (CY) 2023 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies.” MedPAC’s comments address provisions involving a proposed Medicare Advantage coding pattern adjustment. Find MedPAC’s comments here.
- MedPAC has submitted formal comments to CMS in response to that agency’s notice of proposed rulemaking titled “Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs.” Find MedPAC’s letter here.
- MedPAC met virtually last week. Find a transcript of that meeting here and go here for links to presentations on findings from MedPAC’s annual beneficiary and clinician focus groups; Medicare payment policies to support safety-net providers; opportunities to strengthen the geriatric workforce; integrating episode-based payment with population-based payment; and improving Medicare Advantage risk adjustment by limiting the influence of outlier predictions
Medicaid and CHIP Payment and Access Commission (MACPAC)
- In a letter to CMS, MACPAC commented on CMS’s proposed rule “Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs.” MACPAC generally supported changes intended to promote integration of care for dually eligible beneficiaries by applying features of the Medicare-Medicaid plans operating under the Financial Alignment Initiative to Medicare Advantage dual eligible special needs plans (D-SNPs) but urged CMS to look for ways to expand policies to promote integration beyond D-SNPs and offered suggestions for future rule-making. Find MACPAC’s letter here.
- MACPAC has posted “Medicaid Managed Care Capitation Rate Setting,” a new issue brief in which it offers a history of federal regulation of Medicaid capitation payments, describes current federal rate-setting standards and processes, describes the tools available to states to manage various risks, and discusses several policy issues relevant to developing Medicaid capitation rates.
- MACPAC met virtually last week. For the agenda of that meeting, a summary of the proceedings, and links to the presentations delivered during the sessions, go here. Among other subjects, those presentations address Medicaid managed care directed payments, electronic health records and the delivery of behavioral health care, Medicaid and health equity, integrated care for the dually eligible, Medicaid managed care rate-setting, and Medicaid home- and community- based services.
Government Accountability Office (GAO)
- Medicare adjusts how much it pays for physician services based on the geographic area where physicians work, paying more for physicians’ service in areas where approximate costs for their time, skills, and effort are higher than the national average and less in areas where costs are lower. In the new study “Medicare: Information on Geographic Adjustments to Physician Payments for Physicians’ Time, Skills, and Effort,” the GAO examines this system and its effectiveness, concluding that it generally does a good job of adjusting for differences in an area’s relevant costs.
CMS – Emerging Technologies – March 31
CMS will hold public listening sessions on transitional coverage for emerging technologies on Thursday, March 31, also at 3:00 (eastern). The purpose of these sessions is to obtain feedback to help inform CMS’s development of an alternative coverage pathway to provide transitional coverage for emerging technologies following the repeal of the January 2021 Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” final rule. For additional information about the listening sessions and to register to participate, go here.
CMMI – Medicare Advantage Value-Based Insurance Design Model – 2023 Hospice Benefit Component Overview – April 5
CMMI will host an office hours session on Tuesday, April 5, 2022 at 3:00 p.m. (eastern) to discuss the Medicare Advantage Value-Based Insurance Design Model and its Hospice Benefit Component. Participants will receive an overview of the model and the CY 2023 application process and have an opportunity for questions and answers with the model team. For more information about the program and how to register for the event, go here.