Alston & Bird Health Care Week in Review, September 25, 2020

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:

On Thursday, President Trump unveiled his “America First” health care plan, which includes a pledge to protect preexisting conditions and address surprise billing. Read more about these actions and other news below.

I. Regulations, Notices & Guidance

• On September 21, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a rule entitled, Medicare Program: Specialty Care Models to Improve Quality of Care and Reduce Expenditures. This final rule implements two new mandatory Medicare payment models under section 1115A of the Social Security Act—the Radiation Oncology Model (RO Model) and the End-Stage Renal Disease (ESRD) Treatment Choices Model (ETC Model). The RO Model will promote quality and financial accountability for providers and suppliers of radiotherapy (RT). The RO Model will be a mandatory payment model and will test whether making prospective episode payments to hospital outpatient departments (HOPD) and freestanding radiation therapy centers for RT episodes of care preserves or enhances the quality of care furnished to Medicare beneficiaries while reducing Medicare program spending through enhanced financial accountability for RO Model participants. The ETC Model will be a mandatory payment model focused on encouraging greater use of home dialysis and kidney transplants, in order to preserve or enhance the quality of care furnished to Medicare beneficiaries while reducing Medicare expenditures. The ETC Model adjusts Medicare payments on certain dialysis and dialysis-related claims for participating ESRD facilities and clinicians caring for beneficiaries with ESRD—or Managing Clinicians—based on their rates of home dialysis transplant waitlisting, and living donor transplants.
• On September 21, 2020, the Food and Drug Administration (FDA) issued guidance entitled, Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. FDA is issuing this guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity for the duration of the COVID-19 public health emergency. The appendix to this guidance further explains those general considerations by providing answers to questions that the Agency has received about conducting clinical trials during the COVID-19 public health emergency.
• On September 22, 2020, FDA issued a proposed rule entitled, Regulations Regarding Intended Uses. FDA is proposing to amend its medical product “intended use” regulations. This action, if finalized, will amend FDA’s regulations describing the types of evidence relevant to determining whether a product is intended for use as a drug or device under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Public Health Service Act (PHS Act), and FDA’s implementing regulations, including whether an approved or cleared medical product is intended for a new use.
• On September 24, 2020, the Department of Health and Human Services (HHS) issued a rule entitled, Implementation of Executive Order 13937, Executive Order on Access to Affordable Life-saving Medications. HHS proposes to implement the Executive Order 13937 (Executive Order) of July 24, 2020. The Executive Order requires that entities funded under section 330(e) of the PHS Act, whether by receiving a federal award or a subaward, and who also participate in the 340B Drug Pricing Program, must establish practices to provide access to insulin and injectable epinephrine to low-income patients at the price the health center purchased these two drugs through the 340B Drug Pricing Program. The Executive Order supports the improved access to these life-saving medications by low-income individuals who do not have access to affordable insulin and injectable epinephrine due to either lack of insurance or high cost sharing requirements. HHS is seeking public comment on this notice of proposed rulemaking (NPRM).
• On September 25, 2020, FDA issued guidance entitled, The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program. The Pilot Accreditation Scheme for Conformity Assessment Program (ASCA Pilot) is authorized under section 514(d) of the FD&C Act. In accordance with amendments made to section 514 by the FDA Reauthorization Act of 2017 (FDARA), and as part of the enactment of the Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA was directed to issue a guidance regarding the goals and implementation of the ASCA Pilot. The establishment of the goals, scope, procedures, and a suitable framework for the voluntary ASCA Pilot supports the Agency's continued efforts to use its scientific resources effectively and efficiently to protect and promote public health. FDA believes the voluntary ASCA Pilot may further encourage international harmonization of medical device regulation because it incorporates elements, where appropriate, from a well-established set of international conformity assessment practices and standards (e.g., ISO/IEC 17000 series). The voluntary ASCA Pilot does not supplant or alter any other existing statutory or regulatory requirements governing the decision-making process for premarket submissions. This guidance refers to voluntary consensus standards.
• On September 25, 2020, FDA issued guidance entitled, Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program. This guidance provides information on how the Biological Evaluation of Medical Devices standards are incorporated into the ASCA Pilot.
• On September 25, 2020, FDA issued guidance entitled, Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program. This guidance provides information regarding how the basic safety and essential performance standards are incorporated into the ASCA Pilot.
• On September 25, 2020, FDA issued a final rule entitled, Importation of Prescription Drugs. This final rule would implement a provision of the FD&C Act to allow importation of certain prescription drugs from Canada. Under this final rule, States and Indian Tribes, and in certain future circumstances pharmacists and wholesalers, may submit importation program proposals to the FDA for review and authorization. An importation program may be cosponsored by a State, Indian Tribe, pharmacist, or wholesaler. The final rule contains all requirements necessary for a sponsor to demonstrate that their importation program will pose no additional risk to the public’s health and safety. In addition, the final rule requires that the sponsor explain how they will ensure their program will result in a significant reduction in the cost of covered products to the American consumer.
• On September 25, 2020, FDA issued guidance entitled, Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, and Combination Products Under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act. This guidance describes recommended procedures to obtain a National Drug Code (NDC) for certain FDA-approved prescription drugs that are imported into the United States in compliance with the FD&C Act, which would provide an additional avenue through which these drugs could be sold at a lower cost in the U.S. market. This guidance is intended to address certain challenges in the private market faced by manufacturers seeking to sell their drugs at lower costs.

Event Notices

• October 2, 2020: FDA announced a public meeting entitled, Meeting of the Vaccines and Related Biological Products Advisory Committee. The committee will discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2021 southern hemisphere influenza season.
• October 8, 2020: FDA announced a public meeting entitled, Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss new drug application (NDA) 211179, for amphetamine sulfate immediate-release oral capsules, submitted by Arbor Pharmaceuticals, LLC, for the proposed indication of treatment of attention deficit hyperactivity disorder.
• October 26, 2020: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Meeting of the Board of Scientific Counselors, Center for Preparedness and Response (CPR). The agenda will include discussions on updates from the CPR Director and Division Directors, CPR Strategic Planning and Science Agenda, and CPR BSC Polio Containment Workgroup (PCWG) Updates.
• October 27, 2020: FDA announced a public meeting entitled, Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027. The purpose of the meeting is to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years 2023 through 2027 (MDUFA V).
• October 28-29, 2020: CDC announced a public meeting entitled, Meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC). The agenda will include agency updates from CDC, CMS, and FDA. The focus of the meeting is Clinical Laboratory Medicine in the Age of COVID-19 and will include presentations and discussions on preparedness and response: the partnership between clinical laboratories and public health; laboratory data exchanges during COVID-19; and the clinical laboratory’s role in identifying health inequities during the COVID-19 response.
• October 30, 2020: FDA announced a public workshop entitled, New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation. The purpose of the public workshop is to seek public comments/feedback on the Integrated Review documentation generated by the new Integrated Assessment of marketing applications for new drug products developed as part of the New Drugs Regulatory Program Modernization.
• November 5, 2020: CDC announced a public meeting entitled, Meeting of the Healthcare Infection Control Practices Advisory Committee. The agenda will include updates from the following HICPAC workgroups: The Healthcare Personnel Guideline Workgroup; the Long-term Care/Post-acute Care Workgroup; and the Neonatal Intensive Care Unit Workgroup.
• November 9, 2020: FDA announced a public meeting entitled, Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee. On November 9, 2020, the committee will discuss, make recommendations and vote on information regarding the PMA for the VisAbility Micro Insert sponsored by Refocus Group, Inc.

II. Congressional Hearings

U.S. House of Representatives

• On September 23, 2020, the House Committee on Energy and Commerce Subcommittee on Health held a hearing entitled, Health Care Lifeline: The Affordable Care Act and the COVID-19 Pandemic. Witnesses present included: Dr. Aviva Aron-Dine, Ph.D., Vice President for Health Policy Center on Budget and Policy Priorities; Dean Cameron, Director, Idaho Department of Insurance; Dr. Douglas Holtz-Eakin, President, American Action Forum; Peter Lee, Executive Director, Covered California; and Dr. Benjamin D. Sommers, M.D., Ph.D., Huntley Quelch Professor of Health Care Economics, Professor of Health Policy & Economics/Professor of Medicine, Harvard T.H. Chan School of Public Health/Brigham & Women’s Hospital.

U.S. Senate

• On September 23, 2020, the Senate Committee on Health, Education, Labor and Pensions held a hearing entitled, COVID-19: An Update on the Federal Response. Witnesses present included: Dr. Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH); Dr. Robert Redfield, Director, CDC; ADM Brett Giroir, Assistant Secretary for HHS; and Dr. Stephen Hahn, Commissioner of Food and Drugs, FDA.

III. Reports, Studies & Analyses

• On September 21, 2020, the Government Accountability Office (GAO) published a report entitled, COVID-19: Federal Efforts Could Be Strengthened by Timely and Concerted Actions. This report updates GAO’s oversight of federal actions to support public health, individuals, and the economy during the COVID-19 pandemic. Findings include: (1) Shortages of personal protective equipment and testing supplies because very few of them are made in the U.S. and global demand for them is high; (2) HHS may be able to collect more complete data on COVID-19 cases, hospitalizations, and deaths among racial and ethnic minority groups; and (3) The Department of the Treasury and the IRS do not know how many eligible people have yet to receive an economic impact payment. GAO is making 16 recommendations to address these and other issues.
• On September 21, 2020, RAND Corporation published a report entitled, COVID-19 Vaccinations: Liability and Compensation Considerations for Policymakers. This report examines liability and compensation issues as they relate to the future distribution and administration of the COVID-19 vaccine.
• On September 22, 2020, Kaiser Family Foundation (KFF) published an issue brief entitled, Medicaid Maintenance of Eligibility (MOE) Requirements: Issues to Watch When They End. To help support states and promote stability of coverage amidst the COVID-19 pandemic, federal legislation provides a temporary increase in federal Medicaid matching rates to states conditioned on states providing continuous eligibility for existing enrollees and meeting certain other eligibility requirements. This brief provides an overview of these maintenance of eligibility (MOE) requirements, examines what happens when the MOE expires, and discusses key issues to consider looking ahead.

IV. Other Health Policy News

• On September 22, 2020, HHS announced approximately $341 million in funding to 55 states, territories and nonprofit organizations through the Maternal, Infant and Early Childhood Home Visiting (MIECHV) Program and approximately $16 million in funding to the State Maternal Health Innovation (State MHI) Program to improve maternal health outcomes. More information about this funding can be found here.
• On September 22, 2020, CMS announced that it will expand the Medicare Prior Authorization Model for Repetitive, Scheduled Non-Emergent Ambulance Transport (RSNAT) nationwide. The model has saved Medicare about $650 million over four years while preserving quality of care and access to essential services. More information about the announcement can be found here.
• On September 23, 2020, CMS announced the availability of up to $165 million in supplemental funding to states currently operating Money Follows the Person (MFP) demonstration programs. This funding will help state Medicaid programs jump-start efforts to transition individuals with disabilities and older adults from institutions and nursing facilities to home and community-based settings of their choosing. More information about this funding can be found here.
• On September 23, 2020, HHS announced upcoming action by the Centers for Disease Control and Prevention (CDC) to provide $200 million to jurisdictions for COVID-19 vaccine preparedness. More information on this funding can be found here.
• On September 24, 2020, President Trump unveiled his “America First” healthcare plan, signing an executive order based on three pillars: (1) more choice, (2) lower costs, and (3) better care. The executive order lays out a vision for quality health care at affordable prices, with lower prescription drug costs, more consumer choice, and greater transparency. The order includes a pledge to protect those with preexisting conditions and a directive to HHS to address surprise billing if Congress has not acted by the end of the year. A summary of the executive order can be found here.
• On September 24, 2020, CMS released the Calendar Year (CY) 2021 participation in the Medicare Advantage (MA) Value-Based Insurance Design (VBID) Model and information about the CY 2022 application process for eligible MA organizations. More information about this announcement can be found here.

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