Alston & Bird Health Care Week in Review, September 4, 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 Wednesday, CMS published its FY 2021 Medicare Hospital Inpatient Prospective Payment System and Long-Term Acute Care Hospital Final Rule. Read more about the final rule and other news below. 

I. Regulations, Notices & Guidance

• On August 31, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Medicare Coverage of Innovative Technology and Definition of Reasonable and Necessary. This proposed rule would establish a Medicare coverage pathway to provide Medicare beneficiaries nationwide with faster access to new, innovative medical devices designated as breakthrough by the FDA. After the final rule is effective, the Medicare Coverage of Innovative Technology (MCIT) pathway would begin national Medicare coverage on the date of FDA market authorization and would continue for 4 years. CMS is also proposing regulatory standards to be used in making reasonable and necessary determinations under section 1862(a)(1)(A) of the Social Security Act for items and services that are furnished under Part A and Part B.
• On August 2, 2020, the Food and Drug Administration (FDA) issued guidance entitled, Control of Nitrosamine Impurities in Human Drugs. This guidance recommends steps manufacturers of active pharmaceutical ingredients and drug products should take to detect and prevent objectionable levels of nitrosamine impurities in pharmaceutical products. The guidance also describes conditions that may introduce nitrosamine impurities. The recent unexpected finding of nitrosamine impurities, which are probable human carcinogens, in drugs such as angiotensin II receptor blockers, ranitidine, nizatidine, and metformin, has made clear the need for a risk assessment strategy to identify and minimize nitrosamines in any pharmaceutical product at risk for their presence.
• On August 2, 2020, FDA issued guidance entitled, Investigational COVID-19 Convalescent Plasma. On August 23, 2020, FDA issued an Emergency Use Authorization (EUA) for COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19. FDA recognizes that while COVID-19 convalescent plasma may be used under an EUA consistent with the authorization, COVID-19 convalescent plasma may also be used under an investigational new drug application (IND). For the purposes of this guidance, the term “COVID-19 convalescent plasma” refers to the convalescent plasma authorized under the EUA, while the term “investigational convalescent plasma” refers to convalescent plasma that does not meet all the conditions of the EUA and/or is being used under an IND.
• On August 2, 2020, CMS issued a final rule entitled, Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Final Policy Changes and Fiscal Year 2021 Rates; Quality Reporting and Medicare and Medicaid Promoting Interoperability Programs Requirements for Eligible Hospitals and Critical Access Hospitals. CMS is revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from CMS’s continuing experience with these systems for FY 2021 and to implement certain recent legislation. CMS is also making changes relating to Medicare graduate medical education (GME) for teaching hospitals. In addition, CMS is providing the market basket update that will apply to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis, subject to these limits for FY 2021. CMS is updating the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2021. In this FY 2021 IPPS/LTCH PPS final rule, CMS is finalizing changes to the new technology add-on payment pathway for certain antimicrobial products and other changes to new technology add-on payment policies, and the collection of market-based rate information on the Medicare cost report for cost reporting periods ending on or after January 1, 2021 and finalizing the adoption of a market-based MS-DRG relative weight methodology beginning in FY 2024. CMS is establishing new requirements or revising existing requirements for quality reporting by acute care hospitals and PPS-exempt cancer hospitals. CMS also established new requirements and revised existing requirements for eligible hospitals and critical access hospitals (CAHs) participating in the Medicare and Medicaid Promoting Interoperability Programs. CMS is also establishing performance standards for the Hospital Value-Based Purchasing (VBP) Program, and updating policies for the Hospital Readmissions Reduction Program and the Hospital-Acquired Condition (HAC) Reduction Program.
• On September 3, 2020, FDA issued guidance entitled, Pharmacokinetics in Patients with Impaired Renal Function—Study Design, Data Analysis, and Impact on Dosing. In general, drug development programs should be conducted so that when products are approved, the labeling provides appropriate dosing recommendations for patients with renal impairment. This draft guidance revises and replaces the draft guidance entitled "Pharmacokinetics in Patients with Impaired Renal Function—Study Design, Data Analysis, and Impact on Dosing and Labeling" (March 2010) and is meant to assist sponsors in the design and analysis of studies that assess the influence of impaired renal function on the pharmacokinetics (PK) and/or pharmacodynamics of an investigational drug and how such information can impact dosing.
• On September 3, 2020, FDA issued guidance entitled, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process”. FDA has developed this guidance document to assist industry in preparing Premarket Applications (PMAs), Humanitarian Device Exceptions (HDEs), Investigational Device Applications (IDEs), Premarket Notifications (510(k)s), and De Novo requests for medical devices that come into direct contact or indirect contact with the human body in order to determine the potential for an unacceptable adverse biological response resulting from contact of the component materials of the device with the body. The purpose of this guidance is to provide further clarification and updated information on the use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" to support applications to FDA. This guidance replaces Office of Device Evaluation (ODE) Blue Book Memorandum #G95-1 (1995), entitled "Use of International Standard ISO-10993, ‘Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing.’" This guidance document also incorporates several new considerations, including the use of risk-based approaches to determine if biocompatibility testing is needed, chemical assessment recommendations, and recommendations for biocompatibility test article preparation for devices with submicron or nanotechnology components and for devices made from in situ polymerizing and/or absorbable materials, which were not previously discussed in G95-1.

Event Notices         

• September 8-9, 2020: FDA announced a public meeting entitled, Meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. During the meeting, the committee will discuss the classification of several medical devices.
• September 14, 2020: The Department of Health and Human Services (HHS) announced a public meeting entitled, Meeting of the National Committee on Vital and Health Statistics. The National Committee on Vital and Health Statistics (NCVHS), Subcommittee on Privacy, Confidentiality, and Security, will explore the privacy, confidentiality, and security considerations for data collection and use during a public health emergency, in light of the nationwide COVID-19 pandemic.
• September 15, 2020: FDA announced a public meeting entitled, Meeting of the Pediatric Advisory Committee. The committee will discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and the Pediatric Research Equity Act of 2003 (Pub. L. 108-155).
• September 22, 2020: CDC announced a public meeting entitled, Meeting of the Advisory Committee on Immunization Practices (ACIP). The agenda will include discussions on COVID-19 vaccines.
• September 23-24, 2020: HHS announced a public meeting entitled, Meeting of the National Vaccine Advisory Committee (NVAC). During the September 2020 NVAC meeting, sessions will focus on future coronavirus vaccines, the upcoming flu season, immunization equity, and routine vaccination.
• 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 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 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 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 1, 2020, the House Select Subcommittee on the Coronavirus Crisis held a hearing with U.S. Department of Treasury Secretary Steven T. Mnuchin on the Trump Administration’s response to the economic crisis resulting from the COVID-19 pandemic.

III. Reports, Studies & Analyses

• On August 31, 2020, the Government Accountability Office (GAO) published a report entitled, COVID-19: Brief Update on Initial Federal Response to the Pandemic. The CARES Act includes a provision for GAO to report bimonthly on its ongoing monitoring and oversight efforts related to COVID-19. This second report examines federal spending on the COVID-19 response; indicators for monitoring public health and the economy; and the status of matters for congressional consideration and recommendations from GAO’s June 2020 report.
• On September 1, 2020, the Kaiser Family Foundation (KFF) published an issue brief entitled, Overlooked and Undercounted: The Growing Impact of COVID-19 on Assisted Living Facilities. While COVID-19 outbreaks and deaths in nursing homes have received a fair amount of attention, assisted living facilities, which are home to over 800,000 mostly frail, elderly residents, have been largely overlooked. Unlike nursing homes, assisted living facilities are not federally regulated, leaving states to decide whether or not to publicly report data or to impose restrictions to protect residents. This analysis examines the impact of COVID-19 on assisted living facilities as well as changes over time, using state-level data on COVID-19 cases and deaths reported in early June 2020, and again in early August. These counts are a subset of the state-level COVID-19 cases and deaths in all long-term care facilities, including nursing homes, as reported in other KFF analyses.
• On September 2, 2020, KFF published an issue brief entitled, What We Know About Provider Consolidation. This brief provides an overview of existing research that examines the impact of provider consolidation on health care costs and quality. There are two major types of consolidation among health care providers, both of which are discussed in this brief. The first is horizontal consolidation, which occurs when two providers performing similar functions join, such as when two hospitals merge or groups of physician practices merge to form larger group practices. The second type is vertical integration, which refers to one type of entity purchasing another in the supply chain such as hospitals acquiring physician practices.

IV. Other Health Policy News

• On August 31, 2020, HHS extended coverage under the Public Readiness and Emergency Preparedness Act (PREP Act) to licensed health-care practitioners prescribing or administering point-of-care COVID-19 tests, using anterior nares specimen collection or self-collection, for screening in congregate facilities across the U.S. More information about this decision can be found here.
• On September 1, 2020, The Federal Communications Commission (FCC), U.S. Department of Health and Human Services (HHS), and U.S. Department of Agriculture (USDA) announced that they signed a Memorandum of Understanding to work together on the Rural Telehealth Initiative, a joint effort to collaborate and share information to address health disparities, resolve service provider challenges, and promote broadband services and technology to rural areas in America. More information about this announcement can be found here.
• On September 1, 2020, HHS announced that assisted living facilities may now apply for funding under the Provider Relief Fund Phase 2 General Distribution allocation. More information about this announcement can be found here.
• On September 3, 2020, HHS released a Rural Action Plan, the first HHS-wide assessment of rural healthcare efforts in more than 18 years and the product of HHS’s Rural Task Force. This action plan provides a roadmap for HHS to strengthen departmental coordination to better serve the millions of Americans who live in rural communities across the United States. More information about the Rural Action Plan can be found here.
• On September 3, 2020, HHS announced the details of a $2 billion Provider Relief Fund performance-based incentive payment distribution to nursing homes. This distribution is the latest update in the previously announced $5 billion in planned support to nursing homes grappling with the impact of COVID-19. More information about this distribution can be found here.
• On September 3, 2020, CMS launched Care Compare, a streamlined redesign of eight existing CMS health care compare tools available on Medicare.gov. Care Compare provides a single, user-friendly interface that patients and caregivers can use to make informed decisions about health care based on cost, quality of care, volume of services, and other data. More information about this new tool can be found here.

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