Alston & Bird Health Care Week in Review, June 18, 2021

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, MedPAC and MACPAC released their June 2021 Reports to Congress, and the U.S. Supreme Court upheld the ACA in a 7-2 vote. Read more about these actions and other news below.

I. Regulations, Notices & Guidance

• On June 15, 2021, the Department of Health and Human Services (HHS) issued a proposal to rescind the final rule entitled, Implementation of Executive Order on Access to Affordable Life-Saving Medications. HHS is proposing the rescission due to undue administrative costs and burdens that implementation would impose on health centers. In particular, the final rule would require health centers to create and sustain new practices necessary to determine patients’ eligibility to receive certain drugs at or below the discounted price paid by the health center or subgrantees under the 340B Program, resulting in reduced resources available to support critical services to their patients—including those who use insulin and injectable epinephrine. These challenges would be significantly exacerbated by the multitude of demands on health centers related to the COVID-19 pandemic. HHS is seeking public comment on this notice of proposed rulemaking (NPRM). As Executive Order 13937 remains in effect, should the final rule be rescinded, other implementation approaches will be considered to effectuate the Executive Order.
• On June 17, 2021, FDA issued guidance entitled, Premenopausal Women with Breast Cancer: Developing Drugs for Treatment. This guidance provides recommendations to sponsors developing drugs or biological products regulated by CDER and CBER for the treatment of breast cancer. Specifically, this guidance includes recommendations regarding the inclusion of premenopausal women, as defined by serum hormonal levels (including but not limited to follicle-stimulating hormone and estradiol), in breast cancer clinical trials. The issues of fertility and fertility preservation when treating premenopausal women with breast cancer are outside the scope of this guidance and are not addressed.
• On June 18, 2021, the Food and Drug Administration (FDA) issued guidance entitled, Remanufacturing of Medical Devices. This draft guidance is intended to help clarify whether activities performed on devices are likely "remanufacturing." Such clarification is intended to help provide consistency and better understanding of applicable statutory and regulatory requirements. This draft guidance also includes recommendations for information that should be included in labeling to help assure the continued quality, safety, and effectiveness of devices that are intended to be serviced over their useful life. In drafting this guidance, FDA considered objective evidence and information learned from the Agency's activities discussed in this draft guidance.

Event Notices

• June 23, 2021: FDA announced a public workshop entitled, Fiscal Year 2021 Generic Drug Science and Research Initiatives Workshop. The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives.
• June 24, 2021: The Centers for Medicare & Medicaid Services (CMS) announced a public meeting regarding new and reconsidered clinical diagnostic laboratory test codes for the Clinical Laboratory Fee Schedule for calendar year (CY) 2022. This notice announces a public meeting to receive comments and recommendations (including data on which recommendations are based) on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System codes being considered for Medicare payment under the Clinical Laboratory Fee Schedule (CLFS) for CY 2022. This meeting also provides a forum for those who submitted certain reconsideration requests regarding final determinations made last year on new test codes and for the public to provide comment on the requests.
• June 25, 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 the inequities and the impact of long-COVID or Post-Acute Sequelae of SARS-CoV-2 infection (PASC), and access to personal protection equipment, testing, and therapeutics that are related to this pandemic.
• July 7-9, 2021: CMS announced a public meeting entitled, New Revisions to the Healthcare Common Procedure Coding System (HCPCS) Code Set. The purpose of the meeting is to discuss preliminary coding recommendations for new revisions to the HCPCS Level II code set.
• June 29-30, 2021: HHS announced a public meeting entitled, Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. This meeting will be dedicated to the council’s deliberation and vote on two reports to transmit to the HHS Secretary, the first from the Disparities in Antibiotics Access and Use Working Group, and the second from the Working Group on Antimicrobial Resistance (AMR) in Inter-Professional Education. The remainder of the two-day public meeting will include an update on the status of the antibiotic development pipeline and an open council discussion on provocative questions in AMR (no recommendations will be made), in addition to presentations from subject matter experts on Operationalizing One Health and the Environmental Dimensions of AMR.
• 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.

II. Congressional Hearings

U.S. Senate

• On June 15, 2021, the Senate Committee on Finance held a hearing entitled, Mental Health Care in America: Addressing Root Causes and Identifying Policy Solutions. Witnesses present included: Benjamin Miller, PsyD, Chief Strategy Officer, Well Being Trust; Chantay Jett, MA, MFT, Executive Director, Wallowa Valley Center Wellness; Michelle Durham, MD, MPH, FAPA, DFAACAP, Assistant Professor of Psychiatry at Boston University School of Medicine, Vice Chair of Education for the Department of Psychiatry, Department of Psychiatry Residency Training Director for General Psychiatry Residency, Associate Director, Global and Local Center for Mental Health Disparities, Boston Medical Center; and Thomas Betlach, MPA, Partner, Former Arizona Medicaid Director and Single State Authority Director for Mental Health and Substance Abuse, Arizona Department of Health Services.
• On June 17, 2021, the Senate Committee on Aging held a hearing entitled, 21st Century Caregiving: Supporting Workers, Family Caregivers, Seniors and People with Disabilities. Witnesses present included: Ai-jen Poo, Executive Director, National Domestic Workers Alliance; Stephanie Blunt, Executive Director, Trident Area Agency on Aging; Brittany Williams, Home Care Worker, SEIU 775 Member; and Theo Braddy, Consultant and Former CEO, Center for Independent Living of Central Pennsylvania.

U.S. House of Representatives

• On June 15, 2021, the House Committee on Energy and Commerce Subcommittee on Health held a hearing entitled, Booster Shot: Enhancing Public Health through Vaccine Legislation. Witnesses present included: Phyllis Arthur, Vice President, Infectious Diseases and Diagnostic Policy Biotechnology Innovation Organization; Rebecca Coyle, Executive Director, American Immunization Registry Association; Dr. Yvonne Maldonado, Chair, Committee on Infectious Diseases, American Academy of Pediatrics Professor of Pediatrics and of Epidemiology and Public Health, Stanford University; and Dr. Lijen Tan, Chief Strategy Officer, Immunization Action Coalition.
• On June 16, 2021, the House Committee on Education and Labor held a hearing entitled, Examining the Policies and Priorities of the U.S. Department of Health and Human Services. HHS Secretary Xavier Becerra served as the sole witness.

III. Reports, Studies & Analyses

• On June 15, 2021, the Bipartisan Policy Center published a report entitled, Key Considerations in the Development of a Medicaid Home- and Community-Based Services Benefit. In developing legislation to expand the availability of Medicaid home- and community-based services (HCBS), policymakers will need to consider a number of issues. In May of 2021, The Bipartisan Policy Center hosted a private roundtable discussion with experts, supplemented by individual interviews. Experts included state-level policymakers, consumer advocates, plans, and providers. This paper discusses the key challenges and opportunities identified by experts in expanding Medicaid HCBS, and outlines options for congressional consideration. It is important to note, however, that some experts indicated that an expansion of HCBS should be done through the Medicare program, rather than Medicaid, and several proposals have been introduced to create a Medicare long-term care benefit.
• On June 16, 2021, the Kaiser Family Foundation (KFF) published an issue brief entitled, How Do CMS’s New COVID-19 Vaccine Reporting and Education Rules Apply To Different Long-Term Care Settings? Recognizing that ongoing vaccination efforts are crucial to ending the pandemic, CMS issued an Interim Final Rule with Comment Period (IFC) that establishes new vaccine reporting and/or education requirements for nursing homes and ICF/IIDs as of May 21, 2021. Public comments are due July 12, 2021, after which CMS may revise the rule. CMS also seeks public comment about whether similar requirements should apply to inpatient behavioral health settings and community-based congregate settings. This issue brief explains the new requirements and identifies where gaps remain across different LTCF settings.
• On June 17, 2021, the Bipartisan Policy Center published a report entitled, The Cost of Waiting to Act on Medicare’s Hospital Insurance Trust Fund. Medicare is the nation’s largest health insurance program, covering more than 60 million beneficiaries—primarily Americans over age 65, and younger people with certain health conditions. Administered by the federal government and funded by a combination of payroll taxes, general revenues, premiums, and other sources, the program faces significant financial challenges, with expenditures in recent years consistently outpacing dedicated revenue streams. As these funding imbalances have attracted growing attention, a variety of reforms have been proposed to address Medicare’s solvency problems. This paper examines five such proposals, focusing specifically on how each would affect the solvency of the Hospital Insurance (HI) Trust Fund, which finances Medicare Part A (primarily covering inpatient health care services). A February 2021 report by the Congressional Budget Office (CBO) projects that the HI Trust Fund will become insolvent in 2026.
• On June 18, 2021, the Government Accountability Office (GAO) published a report entitled, Medicare Spending on Drugs with Direct-to-Consumer Advertising. GAO was asked to examine direct-to-consumer advertising (DTCA) and Medicare spending on advertised drugs. This report examines (1) drug manufacturer spending on DTCA; (2) Medicare spending on advertised drugs; and (3) changes in DTCA spending and Medicare use and spending for selected drugs.

IV. Other Health Policy News

• On June 14, 2021, HHS, through the Health Resources and Services Administration (HRSA), awarded $125 million in American Rescue Plan Act funds to support 14 nonprofit private or public organizations to reach underserved communities in all 50 states plus the District of Columbia, Puerto Rico, Guam and the Freely Associated States to develop and support a community-based workforce that will engage in locally tailored efforts to build vaccine confidence and bolster COVID-19 vaccinations in underserved communities. More information about this funding can be found here.
• On June 15, 2021, the Medicare Payment Advisory Commission (MedPAC) released its 2021 June Report to the Congress. The annual report primarily focuses on Medicare’s payment policies and provides recommendations on ways to improve these policies where appropriate.
• On June 15, 2021, the Medicaid and CHIP Payment and Access Commission (MACPAC) released its 2021 June Report to the Congress, recommending that Congress take measures to address the effect of high-cost specialty drugs on state Medicaid programs and take steps that would improve access to mental health services for adults and children and adolescents enrolled in Medicaid and the State Children’s Health Insurance Program (CHIP). The report also contains additional topics of interest to Congress such promoting integration of physical and behavioral health care through electronic health records (EHRs), the non-emergency transportation (NEMT) benefit in Medicaid, and state strategies for integrating care for people who are dually eligible for Medicaid and Medicare.
• On June 17, 2021, the HHS Office of the National Coordinator for Health Information Technology (ONC) announced the establishment of an $80 million Public Health Informatics & Technology Workforce Development Program (PHIT Workforce Program) to strengthen U.S. public health informatics and data science. As part of this launch, ONC is inviting college and universities—particularly Historically Black Colleges and Universities (HBCUs), Tribal Colleges and Universities (TCUs), Hispanic Serving Institutions (HSIs), Asian American and Native American Pacific Islander-Serving Institutions (AANAPISIs), and other minority-serving institutions (MSIs)—to apply for funding through a consortium that will develop the curriculum, recruit and train participants, secure paid internship opportunities, and assist in career placement at public health agencies, public health-focused non-profits or public health-focused private sector or clinical settings. More information about this initiative can be found here.
• On June 17, 2021, HHS announced that it is investing more than $3 billion in American Rescue Plan Act funding to accelerate the discovery, development, and manufacturing of antiviral medicines as part of the Biden Administration’s whole-of-government strategy to develop the next generation of COVID-19 treatments. This plan, called the Antiviral Program for Pandemics, will respond to the urgent need for antivirals to treat COVID-19 by spurring the availability of medicines to prevent serious illness and save lives. It also will build sustainable platforms for discovery and development of antivirals for other viruses with pandemic potential, helping better prepare the nation to face future viral threats. More information about this program can be found here.
• June 17, 2021, the U.S. Supreme Court upheld the Affordable Care Act (ACA) in 7-2 vote, saying that the suing states and individuals lacked the legal right to challenge the law because they lacked standing. The two dissenting justices were Samuel Alito and Neil Gorsuch. The ruling marks the third time the Supreme Court has backed central parts of the ACA.

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