Alston & Bird Health Care Week in Review, January 15, 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, CMS issued several rules, while President-elect Biden announced the framework for his COVID-19 relief plan. Read more about these actions and other news below.

I. Regulations, Notices & Guidance

• On January 12, 2021, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary.” This final rule establishes a Medicare coverage pathway to provide Medicare beneficiaries nationwide with faster access to new, innovative medical devices designated as breakthrough by the Food and Drug Administration (FDA). The Medicare Coverage of Innovative Technology (MCIT) pathway will result in 4 years of national Medicare coverage starting on the date of FDA market authorization or a manufacturer chosen date within 2 years thereafter. This rule also implements regulatory standards to be used in making reasonable and necessary determinations under section 1862(a)(1)(A) of the Social Security Act (the Act) for items and services that are furnished under Part A and Part B.
• On January 12, 2021, the Department of Health and Human Services (HHS) issued a final rule entitled, Department of Health and Human Services Transparency and Fairness in Civil Administrative Enforcement Actions. HHS is issuing regulations promoting transparency and fairness in civil enforcement actions. These regulations will help to ensure that regulated parties receive fair notice of laws and regulations they are subject to, and have an opportunity to contest an agency determination prior to the agency taking an action that has a legal consequence.
• On January 13, 2021, FDA issued guidance entitled, COVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity. Due to the current public health emergency, FDA is issuing this guidance to assist sponsors in the development of monoclonal antibodies (mAbs) and other therapeutic proteins for use as COVID-19 therapeutics. A critical quality control measure for these products is the development and implementation of a potency assay(s) adequate to ensure that each lot is consistently produced with the potency necessary to achieve clinical efficacy and that such potency is maintained over the shelf life of the product.
• On January 14, 2021, FDA issued guidance entitled, Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the COVID-19 Public Health Emergency. FDA is issuing this guidance to provide a policy to help expand the availability of coagulation systems for measurement of whole blood viscoelastic properties that are used to assess hemostasis, for the duration of the COVID-19 public health emergency.
• On January 14, 2021, CMS issued a final rule entitled, Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022; Updates to State Innovation Waiver (Section 1332 Waiver) Implementing Regulations. This final rule sets forth provisions related to user fees for federally-facilitated Exchanges and State-based Exchanges on the Federal Platform. It includes changes related to acceptance of payments by issuers of individual market Qualified Health Plans and clarifies the regulation imposing network adequacy standards with regard to Qualified Health Plans that do not use provider networks. It also adds a new direct enrollment option for federally-facilitated Exchanges and State Exchanges and implements changes related to section 1332 State Innovation Waivers.
• On January 14, 2021, FDA and HHS issued a notice and request for information entitled, Making Permanent Regulatory Flexibilities Provided During the COVID-19 Public Health Emergency by Exempting Certain Medical Devices from Premarket Notification Requirements; Request for Information, Research, Analysis, and Public Comment on Opportunities for Further Science and Evidence-Based Reform of Section 510(k) Program. To provide Americans with expanded access to certain medical devices to respond to the COVID-19 Public Health Emergency, FDA issued guidance documents providing numerous regulatory flexibilities, including a temporary waiver of premarket notification requirements under section 510(k) of the Food, Drug, and Cosmetic Act. For seven class I devices for which 510(k) premarket review as temporarily waived during the PHE, HHS is permanently exempting those seven (7) class I devices from the 510(k) requirement and is also proposing to exempt an additional 83 class II devices and 1 unclassified device class from the 510(k) requirement, for which premarket review had also been waived during the PHE. HHS is soliciting the public’s views on whether premarket review should be permanently waived for some or all of these 83 devices and views on ways to improve the 510(k) premarket notification program.
• On January 15, 2021, FDA issued guidance entitled, Investigational COVID-19 Convalescent Plasma: Guidance for Industry. FDA is issuing this guidance to provide recommendations to health care providers and investigators on the use of COVID-19 convalescent plasma or investigational convalescent plasma during the public health emergency. The guidance also provides recommendations to blood establishments on collection.
• On January 15, 2021, FDA issued guidance entitled, Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency. FDA is issuing this guidance to provide recommendations to prospective applicants of abbreviated new drug applications (ANDAs) on ensuring the protection of participants when resuming or initiating bioequivalence (BE) studies conducted to support the approval of an ANDA that have been disrupted during the COVID-19 public health emergency.
• On January 15, 2021, CMS issued a final rule entitled, Patient Protection and Affordable Care Act; Reducing Provider and Patient Burden by Improving Prior Authorization Processes, and Promoting Patients’ Electronic Access to Health Information for Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, and Issuers of Qualified Health Plans on the Federally-facilitated Exchanges; Health Information Technology Standards and Implementation Specifications. This final rule places new requirements on state Medicaid and CHIP fee-for-service (FFS) programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs) to improve the electronic exchange of health care data, and streamline processes related to prior authorization, while continuing CMS’ drive toward interoperability, and reducing burden in the health care market. In addition, on behalf of HHS, the Office of the National Coordinator for Health Information Technology (ONC) is adopting certain specified implementation guides (IGs) needed to support the Application Programming Interface (API) policies included in this rule. Each of these elements plays a key role in reducing overall payer and provider burden and improving patient access to health information.
• On January 15, 2021, CMS issued a final rule entitled, Contract Year 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly. This final rule will revise regulations for the Medicare Advantage (Part C) program, Medicare Prescription Drug Benefit (Part D) program, Medicaid program, Medicare Cost Plan program, and Programs of All-Inclusive Care for the Elderly (PACE) to implement certain sections of the Bipartisan Budget Act of 2018 and the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment- (SUPPORT) for Patients and Communities Act (hereinafter referred to as the SUPPORT Act), enhance the Part C and D programs and the PACE program, codify several existing CMS policies, make required statutory changes, implement other technical changes, and make routine updates.

Event Notices 

• January 19, 2021: The National Institutes of Health (NIH) announced a public meeting entitled, Meeting of the National Advisory Council for Biomedical Imaging and Bioengineering. The purpose of the meeting is for the Institute Director and other Institute staff to present their report.
• January 25, 2021: HHS announced a public meeting entitled, Meeting of the Advisory Council on Alzheimer’s Research, Care, and Services. The Advisory Council will hear presentations on the impact of COVID-19 on people with dementia, health disparities in dementia research, and the implications of new technologies to identify Alzheimer’s disease through a blood tests.
• January 27, 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 vaccines.
• February 2, 2021: FDA announced a public meeting entitled, Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials. The meeting is intended to gather industry, patient, clinician, researcher, institutional review board, ethicist, professional society and other stakeholder input on the scientific and ethical issues that surround the inclusion of pregnant women in clinical trials for drug development.
• February 2, 2021: NIH announced a public meeting entitled, Meeting of the National Advisory Child Health and Human Development Council. The agenda will include opening remarks, administrative matters, Director’s Report, Division of Extramural Research Report, and other business of the Council.
• February 4, 2021: HHS announced a public meeting entitled, Meeting of the National Vaccine Advisory Committee (NVAC). NVAC will hear presentations on vaccine safety, communication activities for COVID-19 vaccines, and immunization equity.
• February 10-11, 2021: HHS announced a public meeting entitled, Meeting of the Presidential Advisory Council on Combatting Antibiotic-Resistant Bacteria (PACCARB). The February 10-11 public meeting will be dedicated to presentations from two new working groups of the PACCARB, one on Inter-Professional Education and another on Antibiotics Access and Use, which were formed in response to a task letter from the Assistant Secretary for Health. The two-day virtual public meeting will also include an update on the impact of COVID-19 on antimicrobial resistance.
• February 11, 2021: NIH announced a public meeting entitled, Meeting of the National Cancer Institute President’s Cancer Panel. The purpose of the meeting is to discuss innovation to increase cancer screening.
• February 11-12, 2021: The Health Resources and Services Administration (HRSA) announced a public meeting entitled, Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children. During the meeting, the Advisory Committee will hear from experts in the fields of public health, medicine, heritable disorders, rare disorders, and newborn screening. Agenda items include a presentation on potential processes for reviewing conditions on the RUSP; potential revisions to the condition nomination form; continuity of operations planning; innovations in long-term follow-up for conditions identified through newborn screening; and workgroup dates.

II. Congressional Hearings

There were no health-related Congressional events this week.

III. Reports, Studies & Analyses

• On January 12, 2021, Kaiser Family Foundation (KFF) published an issue brief entitled, Medicaid Expansion Enrollment and Spending Leading up to the COVID-19 Pandemic. This issue brief analyzes enrollment and spending trends related to the Affordable Care Act’s Medicaid expansion ahead of the pandemic and examines potential consequences of recent enrollment increases.
• On January 13, 2021, KFF published an issue brief entitled, Price Transparency and Price Variation in U.S. Health Services. This issue brief summarizes the key requirements for hospitals, insurers, and self-funded employer plans under new federal price transparency rules. In addition to examining how the new transparency rules may affect patient decision-making, the brief considers their impact on market pricing, including the significant geographic variation in prices for common health services.
• On January 14, 2021, the Senate Finance Committee released the results of their bipartisan investigation into the skyrocketing price of insulin, which they launched nearly two years ago. The investigation sheds light on factors that led to the surging list price of insulin. The Committee is also releasing more than 1,700 pages of documents containing internal emails, contracts, and presentations that served as the basis of the investigation. Full text of the Committee’s investigative report and records can be found here.

IV. Other Health Policy News

• On January 11, 2021, HHS launched a web-based locator for COVID-19 outpatient treatment sites for monoclonal antibodies. To ensure the therapeutic treatments are not in short supply, HHS has agreements in place with Regeneron to purchase approximately 300,000 treatment courses of the company's casirivimab/imdevimab and with Eli Lilly and Company to purchase approximately 3 million treatment courses of the bamlanivimab if needed. More information about this tool and monoclonal antibodies can be found here.
• On January 11, 2021, HHS announced that it has awarded $8 million to fund the Telehealth Broadband Pilot (TBP) program. The TBP program assesses the broadband capacity available to rural health care providers and patient communities to improve their access to telehealth services. More information about this announcement can be found here.
• On January 14, 2021, HHS announced it will publish  Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder, to expand access to medication-assisted treatment (MAT) by exempting physicians from certain certification requirements needed to prescribe buprenorphine for opioid use disorder (OUD) treatment. Specifically, the guidelines issue an exemption from certain certification requirements under 21 U.S.C. § 823(g)(2) of the Controlled Substances Act (CSA) for physicians licensed under State law and who possess a DEA registration. More information about this exemption can be found here.
• On January 14, 2021, President-elect Joe Biden unveiled his $1.9 trillion plan to provide COVID-19 relief to the American public. The “American Rescue Plan” is intended to change the course of the COVID-19 Pandemic through a two-step process: (1) Rescue; and (2) Recovery. Key health provisions of the “rescue” package include, among other things:
  • $20 billion for a national vaccination program in partnership with states, localities, Tribes, and territories.
  • Expanding FMAP to 100% for vaccine administration.
  • $50 billion to expand COVID-19 testing.
  • Funding 100,000 public health workers for vaccine outreach and contact tracing.
  • Addressing health disparities.
  • Measures to protect vulnerable populations in congregate settings.
  • Funding to identify and address new COVID-19 strains.
  • $30 billion for the Disaster Relief Fund for supplies and protective gear.
  • 100% federal reimbursement for critical emergency response resources to states, local governments, and Tribes, including deploying the National Guard.
  • $10 billion to expand domestic manufacturing for pandemic supplies.
  • Investing in COVID-19 treatments and studies of the long-term impact of COVID-19.
  • Subsidizing COBRA through 9/30/2021.
  • Expanding and increasing the value of the Premium Tax Credit to eliminate premiums and ensure enrollees pay no more than 8.5% of income for coverage.
  • $4 billion to SAMHSA to expand access to behavioral health services.
  • $20 billion to the Veterans Health Administration.
  • Authorizing the Occupational Safety and Health Administration (OSHA) to issue a COVID-19 Protection Standard and additional funding for OSHA enforcement and grant funding.
  • $350 billion in emergency funding for state, local, and territorial governments to support first responders and other essential workers.
• On January 15, 2021, HHS announced that it will be amending the reporting timeline for the Provider Relief Fund Program (PRF) due to the recent passage of the Coronavirus Response and Relief Supplemental Appropriations Act. HHS has been working to provide updated reporting requirements that comply with this recently passed legislation. Consequently, PRF recipients will now be required to submit their reporting requirements on their use of these funds later than previously announced. A new deadline has not yet been announced. More information about this announcement can be found here.

Click here to view the members of our Health Care Legislative & Public Policy team.