Alston & Bird Health Care Week in Review, November 20, 2020

I. Regulations, Notices & Guidance

• On November 16, 2020, the Food & Drug Administration (FDA) issued guidance entitled, Electromagnetic Compatibility of Medical Devices. FDA has developed this guidance document to describe relevant information that should be provided in a premarket submission (i.e., premarket approval application (PMA), humanitarian device exemption (HDE), premarket notification (510(k)) submission, investigational device exemption (IDE), and De Novo request) to support a claim of electromagnetic compatibility for electrically powered medical devices and medical devices with electrical or electronic functions. This draft guidance is not intended to change current policy, but to provide specific technical information to address the recommendations originally described in the guidance entitled "Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices" published July 11, 2016 (2016 EMC guidance). This draft guidance is not final nor is it in effect at this time.
• On November 17, 2020, FDA issued guidance entitled, Product-Specific Guidance for Tiotropium Bromide. This draft guidance, when finalized, will provide product-specific recommendations on, among other things, the information and data needed to demonstrate bioequivalence (BE) to support abbreviated new drug applications (ANDAs) for tiotropium bromide inhalation spray.
• On November 18, 2020, FDA issued a notice of availability for several product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of BE studies to support ANDAs.
• On November 19, 2020, FDA issued guidance entitled, Cross Labeling Oncology Drugs in Combination Drug Regimens. This guidance describes FDA’s current recommendations on including relevant information in labeling for oncology drugs approved for use in combination drug regimens.
• On November 19, 2020, FDA issued guidance entitled, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act of 2009. The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars, as well as to describe FDA’s interpretation of certain statutory requirements added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This draft guidance document provides new Q&As. It does not replace the draft guidance document entitled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2),” issued December 12, 2018.
• On November 20, 2020, FDA issued guidance entitled, Clinical Drug Interaction Studies With Combined Oral Contraceptives. This guidance assists sponsors of investigational new drug applications and new drug applications in evaluating the need for and design drug-drug interaction (DDI) studies involving combined oral contraceptives (COCs) during drug development as well as determining how to communicate the results and recommendations from the DDI studies. Specifically, this guidance focuses on the conduct of clinical studies to evaluate the DDI potential of an investigational drug on a COC, including the need for and design of the clinical studies and the interpretation of the study results.
• On November 20, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period (IFC) entitled, Most Favored Nation Model. This IFC implements the Most Favored Nation (MFN) Model, a new Medicare payment model under section 1115A of the Social Security Act (the Act). The MFN Model will test whether more closely aligning payment for Medicare Part B drugs and biologicals (hereafter, referred to as “drugs”) with international prices and removing incentives to use higher-cost drugs can control unsustainable growth in Medicare Part B spending without adversely affecting quality of care for beneficiaries.
• On November 20, 2020, the Department of Health and Human Services (HHS) issued a final rule entitled, Fraud And Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals And Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees. Discounts for prescription pharmaceutical products are central to this final rule, in which the HHS amends the safe harbor regulation concerning discounts. Amending this regulation changes the definition of certain conduct that is protected from liability under the Federal anti-kickback statute of the Social Security Act. New regulatory text in the amendment revises the discount safe harbor. By excluding from the definition of a discount eligible for safe harbor protection certain reductions in price or other remuneration from a manufacturer of prescription pharmaceutical products to plan sponsors under Medicare Part D or pharmacy benefit managers (PBMs) under contract with them, HHS modifies the existing discount safe harbor in particular contexts. Existing safe harbors otherwise remain unchanged. Safe harbors are also created for two additional types of arrangements. The first protects certain point-of-sale reductions in price on prescription pharmaceutical products, and the second protects certain PBM service fees.
• On November 20, 2020, CMS issued a final rule entitled, Modernizing and Clarifying the Physician Self-Referral Regulations. This final rule addresses any undue regulatory impact and burden of the physician self-referral law. This final rule is being issued in conjunction with the CMS Patients over Paperwork initiative and the HHS Regulatory Sprint to Coordinated Care. This final rule establishes exceptions to the physician self-referral law for certain value-based compensation arrangements between or among physicians, providers, and suppliers. It also establishes a new exception for certain arrangements under which a physician receives limited remuneration for items or services actually provided by the physician; establishes a new exception for donations of cybersecurity technology and related services; and amends the existing exception for electronic health records (EHR) items and services. This final rule also provides critically necessary guidance for physicians and health care providers and suppliers whose financial relationships are governed by the physician self-referral statute and regulations.
• On November 20, 2020, HHS issued a final rule entitled, Fraud and Abuse; Revisions to Safe Harbors under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements. This final rule amends the safe harbors to the Federal anti-kickback statute by adding new safe harbors and modifying existing safe harbors that protect certain payment practices and business arrangements from sanctions under the anti-kickback statute. This rule is issued in conjunction with the HHS Regulatory Sprint to Coordinated Care and focuses on care coordination and value-based care. This rule also amends the civil monetary penalty (CMP) rules by codifying a revision to the definition of “remuneration” added by the Bipartisan Budget Act of 2018.

Event Notices         

• December 1, 2020: 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, ACHDNC will hear from experts in the fields of public health, medicine, heritable disorders, rare disorders, and newborn screening. Agenda items include presentations on the decision making criteria and matrix used to evaluate conditions nominated to the RUSP; review of newborn screening implementation for the following RUSP conditions: severe combined immunodeficiency (SCID), critical congenital heart disease (CCHD), Pompe disease, mucopolysaccharidosis type I (MPS I), X-linked adrenoleukodystrophy (XALD); and overview of the Review of Newborn Screening for Spinal Muscular Atrophy (SMA) report and vote on whether to submit this review to the Secretary.
• December 8-9, 2020: FDA announced a public meeting entitled, The Drug Supply Chain Security Act Pilot Project Program and Enhanced Drug Distribution Security. The purpose of the public meeting is to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to discuss with FDA and provide input on strategies and issues related to the enhanced drug distribution security provisions of the Drug Supply Chain Security Act (DSCSA) and the results of FDA’s DSCSA Pilot Project Program.
• December 11, 2020: FDA announced a public workshop entitled, Evaluating the Effect of the Opioid Analgesics Risk Evaluation and Mitigation Strategy Education Program on Prescribing Behaviors and Patient Outcomes—Exploring the Path Forward for Assessment. The purpose of the public workshop is to obtain scientific input on methods to evaluate the Opioid Analgesics Risk Evaluation and Mitigation Strategy (OA REMS) education program. To assist in the workshop discussion, FDA is making available an issues paper that provides a brief overview of the REMS background and challenges with evaluating the REMS education intervention.
• December 15, 2020: FDA announced a public meeting entitled, Meeting of the Cardiovascular and Renal Drugs Advisory Committee. The committee will discuss supplemental new drug application (sNDA) 207620-S18, for the angiotensin receptor-neprilysin inhibitor, ENTRESTO (sacubitril and valsartan) tablets, submitted by Novartis Pharmaceuticals Corp., for the proposed indication of heart failure with preserved ejection fraction (HFpEF)
• December 15-16, 2020: CMS announced a town hall entitled, Meeting on the FY 2022 Applications for New Medical Services and Technologies Add-On Payments. The purpose of the meeting is to discuss FY 2022 applications for add-on payments for new medical services and technologies under the IPPS.
• December 16, 2020: FDA announced a public meeting entitled, Meeting of the Cardiovascular and Renal Drugs Advisory Committee. The committee will discuss spironolactone for the proposed treatment of heart failure with preserved ejection fraction, a serious and often fatal condition for which no drug is approved to improve outcomes.
• January 7, 2020: CMS announced a public meeting entitled, Town Hall Meeting on Merit-based Incentive Payment System (MIPS) Value Pathway (MVP) Implementation. This notice announces a virtual Town Hall meeting for CMS to share updates on the Merit-based Incentive Payment System (MIPS) Value Pathway (MVP) policy considerations and for stakeholders to provide feedback on those MVP considerations for future implementation. Clinicians, professional organizations, third party vendors, stakeholders, and other interested parties are invited to this meeting to present their individual views on MVP design and implementation.

II. Congressional Hearings

U.S. Senate

• On November 17, 2020, the Senate Committee on Commerce, Science, and Transportation Subcommittee on Manufacturing, Trade, and Consumer Protection hearing entitled, Examining the American Manufacturing Industry’s Response to the COVID-19 Pandemic. Witnesses present included: Ravi Bulusu, Founder, MolMas; Mr. Neil Gilman, President, Gilman Gear; Mr. Rick Krska, President and Chief Executive Servant, InkCycle, Inc.; Ms. Tiffany Stovall, Chief Executive Officer, Kansas Manufacturing Solutions; and Mr. Michael Wessel, Commissioner, U.S.-China Economic and Security Review Commission.
• On November 19, 2020, the Senate Committee on Homeland Security and Governmental Affairs hearing entitled Early Outpatient Treatment: An Essential Part of a COVID-19 Solution. Witnesses present included: Dr. Peter A. McCullough, Vice Chief of Internal Medicine, Baylor University Medical Center; Dr. Harvey Risch, Professor of Epidemiology, Yale University; Dr. George C. Fareed, Medical Director and Family Medicine Specialist, Pioneers Medical Center; and Dr. Ashish K. Jha, Dean of the School of Public Health, Brown University.

III. Reports, Studies & Analyses

• On November 18, 2020, the Kaiser Family Foundation (KFF) published an issue brief entitled, Vaccine Coverage, Pricing, and Reimbursement in the U.S. This brief explains how vaccines are covered and paid for through government programs and different types of insurance, including information on specific policies put into place for a COVID-19 vaccine. The brief also includes background information on how the CDC develops vaccine recommendations, since many of the federal vaccine coverage requirements currently in place are tied to those recommendations.
• On November 20, 2020, KFF published an issue brief entitled, Cost-Sharing Waivers and Premium Relief by Private Plans in Response to COVID-19. This updated issue brief estimates the number of enrollees in individual and fully-insured group market plans that have waived cost-sharing – out-of-pocket costs including coinsurance, copayments, and deductibles – for COVID-19 treatment. The analysis also estimates the number of enrollees whose insurer is offering various forms of premium payment relief.

IV. Other Health Policy News

• On November 17, 2020, in an effort to improve access to emerging technologies and healthcare services, the HHS Office of the Assistant Secretary for Health (OASH), in partnership with federal agencies, has issued a Request for Information (RFI) to better inform the direction of Federal efforts. OASH and partners also seek to identify opportunities to strengthen the U.S. healthcare system through public-private partnerships for data sharing, comprehensive analytics, and other potential mechanisms. More information about this announcement can be found here.
• On November 18, 2020, CMS updated certain research-ready Transformed Medicaid Statistical Information System (T-MSIS) data files, which provides for a more robust and evolving collection of Medicaid and Children’s Health Insurance Program (CHIP) data. The data CMS released through T-MSIS provides timely and accurate information on utilization and spending under Medicaid and CHIP, and are needed to enable research and analysis to improve quality of care, assess beneficiary care costs and enrollment, improve program integrity and monitor performance. More information about this update can be found here.

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