Alston & Bird Health Care Week in Review - July 2021 #3

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.


Week in Review Highlight of the Week:

This week, CMS published its annual Physician Fee Schedule proposed rule. Read more about the regulation and other news below.


I. Regulations, Notices & Guidance

  • On July 13, 2021, the Federal Communications Commission (FCC) issued a final rule entitled, Promoting Telehealth for Low-Income Consumers. This rule offers further guidance on the administration of the Connected Care Pilot Program, including guidance on eligible services, competitive bidding, invoicing, and data reporting for selected participants, allowing selected Pilot Program participants to begin their Pilot projects.
  • On July 13, 2021, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, CY 2022 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Provider Enrollment Regulation Updates; Provider and Supplier Prepayment and Post-payment Medical Review Requirements. This major proposed rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; Medicare coverage of opioid use disorder services furnished by opioid treatment programs; updates to certain Medicare provider enrollment policies; requirements for prepayment and post-payment medical review activities; requirement for electronic prescribing for controlled substances for a covered Part D drug under a prescription drug plan, or a Medicare Advantage Prescription Drug (MA-PD) plan; updates to the Medicare Ground Ambulance Data Collection System; changes to the Medicare Diabetes Prevention Program (MDPP) expanded model; and amendments to the physician self-referral law regulations.

Event Notices

  • July 19, 2021: HHS announced a public meeting of the Advisory Council on Alzheimer’s Research, Care, and Services (Advisory Council). The Advisory Council will discuss the implications of and opportunities presented by the approval of aducanumab. The Council will also hear updates from federal workgroups on efforts undertaken in the last quarter. The risk reduction subcommittee will present a summary of their work and recommendations. The research, clinical care, and long-term services and supports subcommittees will present recommendations and the Council will vote on adopting them.
  • July 21-22, 2021: The National Institutes of Health (NIH) announced a public meeting entitled, Approaches to Effective Therapeutic Management of Pain for People with Sickle Cell Disease. This workshop on Sickle Cell Disease Pain aims to explore critical gaps and research challenges, as well as to brainstorm potential solutions for this understudied pain condition in a highly underserved population. This fits into the NIH mission of seeking fundamental knowledge to enhance health.
  • July 22, 2021: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Meeting of the Advisory Committee on Immunization Practices (ACIP). The agenda will include discussions on COVID-19 vaccine safety.
  • July 28, 2021: CMS announced a public meeting entitled, Meeting of the Advisory Panel on Outreach and Education (APOE). The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the CMS Administrator on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP).
  • July 28-29, 2021: CMS announced a public meeting entitled, Meeting of the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests. The purpose of the Panel is to advise the HHS Secretary and CMS Administrator on issues related to clinical diagnostic laboratory tests.
  • July 30, 2021: HHS announced a public meeting entitled, Meeting of the COVID-19 Health Equity Task Force. The purpose of this meeting is to consider interim recommendations addressing future pandemic preparedness, mitigation, and resilience needed to ensure equitable response and recovery in communities of color and other underserved populations.
  • August 12, 2021: The Substance Abuse and Mental Health Services Administration (SAMHSA) Center for Substance Abuse Treatment (CSAT) announced a public meeting. The meeting is open to the public and will include consideration of minutes from the SAMHSA CSAT NAC meeting of March 31, 2021; an update on CSAT activities; a discussion with SAMHSA leadership; and discussion of recovery and recovery support. Interested persons may present data, information, or views, orally or in writing, on issues pending before the Council.
  • September 9, 2021: NIH announced a meeting entitled, Meeting of the National Institute on Minority Health and Health Disparities. The purpose of the meeting it to review and evaluate grant applications.
  • September 21, 2021: The Food and Drug Administration (FDA) announced a public workshop entitled, Considerations for Progressive Multifocal Leukoencephalopathy Clinical Trial Designs. The purpose of the public workshop is to discuss the challenges and clinical trial design considerations for developing therapeutic products for the treatment of progressive multifocal leukoencephalopathy (PML).

II. Congressional Hearings

U.S. House of Representatives

  • On July 12, 2021, the House Committee on Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a markup of the draft Fiscal Year (FY) 2022 Labor-HHS funding bill. The legislation passed by a voice vote.
  • On July 15, 2021, the House Committee on Appropriations held a markup of the draft FY 2022 Labor, Health and Human Services, Education, and Related Agencies funding bill. The legislation passed by a vote of 33-25.
  • On July 15, 2021, the House Committee on Energy and Commerce Subcommittee on Health held a markup of 19 health bills. All 19 bills passed by voice vote.

U.S. Senate

  • On July 13, 2021, the Senate Committee on the Judiciary Subcommittee on Competition Policy, Antitrust, and Consumer Rights held a hearing entitled, A Prescription for Change: Cracking Down on Anticompetitive Conduct in Prescription Drug Markets. Witnesses present included: Michael Kades, Director, Markets and Competition Policy, Washington Center for Equitable Growth; Alden Abbott, Senior Research Fellow, The Mercatus Center at George Mason University; Geoffrey Levitt, Counsel DLA Piper, on behalf of Pharmaceutical Research and Manufacturers of America; Dr. Rachel Moodie, Vice President, Head of Legal and Intellectual Property, Biosimilars, Fresenius Kabi; and David Mitchell, President and Founder, Patients for Affordable Drugs.

III. Reports, Studies & Analyses

  • On July 16, 2021, the Kaiser Family Foundation (KFF) published an issue brief entitled, Health Coverage by Race and Ethnicity, 2010-2019. Health coverage plays a major role in enabling people to access health care and protecting families from high medical costs. People of color have faced longstanding disparities in health coverage that contribute to disparities in health. This brief examines trends in health coverage by race/ethnicity between 2010 through 2019, prior to the onset of the COVID-19, and discusses the implications for health disparities. It is based on KFF analysis of American Community Survey data for the nonelderly population.

IV. Other Health Policy News

  • On July 12, 2021, CMS opened a National Coverage Determination (NCD) analysis to allow the agency to carefully review and determine whether Medicare will establish a national Medicare coverage policy for monoclonal antibodies targeting amyloid for the treatment of Alzheimer’s disease. This NCD analysis will be applicable to national coverage considerations for aducanumab, which was recently approved by the Food and Drug Administration (FDA), as well as any future monoclonal antibodies that target amyloid for the treatment of Alzheimer’s disease. More information about the NCD process can be found here.
  • On July 13, 2021, CMS announced a funding opportunity made possible by the American Rescue Plan to help states strengthen system capacity to provide community-based mobile crisis intervention services for those with Medicaid. The $15 million funding opportunity is available to state Medicaid agencies for planning grants to support developing these programs. More information about this funding can be found here.
  • On July 13, 2021, HHS provided $398 million in American Rescue Plan funding through the Small Rural Hospital Improvement Program (SHIP)to 1,540 small rural hospitals for COVID-19 testing and mitigation. More information about this funding and SHIP can be found here.
  • On July 15, 2021, HHS, through the Health Resources and Services Administration (HRSA), awarded nearly $144 million in American Rescue Plan funding to 102 HRSA Health Center Program look-alikes (LALs) to respond to and mitigate the spread of COVID-19, and enhance health care services and infrastructure in communities across the country. More information about this funding can be found here.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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