Alston & Bird Health Care Week in Review, September 27, 2019

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 September 26, 2019, the Centers for Medicare and Medicaid Services (CMS) released two final rules: one intended to support discharge planning for patients preparing to move from acute care into post-acute care, and the other aimed at reducing physician burden. Read more about these rules below.

I. Regulations, Notices, & Guidance

• On September 23, 2019, the Food and Drug Administration (FDA) issued guidance entitled, Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment. This guidance provides FDA’s current thinking on the clinical development program and clinical trial designs for drugs to support an indication for the treatment of amyotrophic lateral sclerosis (ALS). The guidance addresses the clinical development of drugs intended to treat the main motor aspects of ALS, i.e., muscle weakness and its direct consequences, including shortened life expectancy. It does not address in detail the development of drugs to treat other symptoms that may arise in ALS, such as muscle cramps, spasticity, sialorrhea, pseudobulbar affect, and others. This guidance finalizes the draft guidance of the same name issued on February 16, 2018.
• On September 23, 2019, FDA issued guidance entitled, Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations. The Patient Engagement Advisory Committee (PEAC) recommended that FDA and industry develop some type of framework to clarify how patient advisors can engage in the clinical investigation process. This draft guidance focuses on the applications, perceived barriers, and common challenges of patient engagement in the design and conduct of medical device clinical investigations. This draft guidance is not final nor is it in effect at this time.
• On September 23, 2019, FDA issued guidance entitled, Wholesale Distributor Verification Requirement for Saleable Returned Drug Product--Compliance Policy. This guidance describes FDA’s intention regarding enforcement of the Drug Supply Chain Security Act (DSCSA) provision requiring wholesale distributors to verify a product identifier prior to further distributing returned product beginning on November 27, 2019. Given concerns expressed by stakeholders and to minimize possible disruptions in the pharmaceutical distribution supply chain, FDA does not intend to take action against wholesale distributors who do not, prior to November 27, 2020, verify a product identifier prior to further distributing returned product as required under the DSCSA. This represents a 1-year delay in enforcement of this DSCSA requirement.
• On September 23, 2019, FDA issued a notice entitled, Request for Comments: Post-Marketing Pediatric-Focused Product Safety Reviews. The FDA is establishing a public docket to collect comments related to the post-marketing pediatric-focused safety reviews of products posted between April 12, 2019, and September 23, 2019, on FDA’s website but not presented at the September 26 or 27, 2019, Joint Pediatric Advisory Committee (PAC) and Drug Safety and Risk Management (DSaRM) Advisory Committee meeting. These reviews are intended to be available for review and comment by members of the PAC, interested parties (such as academic researchers, regulated industries, consortia, and patient groups), and the general public. Comments are due by October 7, 2019.
• On September 23, 2019, the Department of Health and Human Services (HHS) issued a notice entitled, Request for Information from Non-Federal Stakeholders: Developing the 2020 National Vaccine Plan. The development of a National Vaccine Plan (NVP) was mandated by Congress as a mechanism for the Director of the National Vaccine Program (as delegated by the Assistant Secretary for Health) to communicate priorities for achieving the Program’s responsibilities of ensuring adequate supply of and access to vaccines and ensuring the effective and optimal use of vaccines. To help inform the development of the National Vaccine Plan 2020, HHS is issuing a Request for Information (RFI). The RFI will solicit specific information regarding the priorities, goals, and objectives in the next iteration of the NVP, remaining gaps, and stakeholder perspectives for the 2020–2025 timeframe.
• On September 23, 2019, CMS issued a final rule entitled, Medicaid Program: State Disproportionate Share Hospital Allotment Reductions. The statute requires aggregate reductions to state Medicaid Disproportionate Share Hospital (DSH) allotments annually beginning with Fiscal Year 2020. This final rule delineates the methodology to implement the annual allotment reductions.
• On September 25, 2019, FDA issued guidance entitled, Providing Regulatory Submissions for Medical Devices in Electronic Format--Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act. Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the FDA Reauthorization Act of 2017 (FDARA) require that certain pre-submissions and submissions for devices be submitted in electronic format specified by FDA beginning on such date as specified in final guidance. It also mandates that FDA issue draft guidance not later than October 1, 2019, providing for further standards for the submission by electronic format, a timetable for establishment of these further standards, and criteria for waivers of and exemptions from the requirements. In addition, in the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter from the Secretary of Health and Human Services to Congress, FDA committed to developing electronic submission templates and issuing a draft guidance on the topic. This guidance is intended to satisfy the draft guidance documents referenced in FDA regulations and the MDUFA IV Commitment Letter.
• On September 26, 2019, FDA issued guidance entitled, Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act. This guidance provides clarity on FDA's current thinking regarding changes made by the 21st Century Cures Act (Cures Act) to the definition of a medical device and the resulting effect on guidances related to medical device software.
• On September 26, 2019, FDA issued guidance entitled, Clinical Decision Support Software. This guidance clarifies the types of clinical decision support (CDS) functions that do not meet the definition of a device as amended by the 21st Century Cures Act (Cures Act). This guidance describes a risk-based approach for regulatory oversight of CDS software functions that remain devices using the categories defined by the International Medical Device Regulators Forum (IMDRF) final document entitled "Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations." The guidance also provides clarity on the types of CDS software functions on which FDA intends to focus its regulatory oversight for health care providers, patients, and caregivers. This draft guidance is not final nor is it in effect at this time.
• On September 26, 2019, CMS issued a final rule entitled, Medicare and Medicaid Programs; Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and Home Health Agencies, and Hospital and Critical Access Hospital Changes to Promote Innovation, Flexibility, and Improvement in Patient Care. This final rule empowers patients to be active participants in the discharge planning process and complements efforts around interoperability that focus on the seamless exchange of patient information between health care settings by revising the discharge planning requirements that Hospitals (including Short-Term Acute-Care Hospitals, Long-Term Care Hospitals (LTCHs), Rehabilitation Hospitals, Psychiatric Hospitals, Children’s Hospitals, and Cancer Hospitals), Critical Access Hospitals (CAHs), and Home Health Agencies (HHAs) must meet in order to participate in the Medicare and Medicaid programs. This final rule also implements discharge planning requirements which will give patients and their families access to information that will help them to make informed decisions about their post-acute care, while addressing their goals of care and treatment preferences, which may ultimately reduce their chances of being re-hospitalized. It also updates one provision regarding patient rights in hospitals, intended to promote innovation and flexibility and to improve patient care.
• On September 26, 2019, CMS issued a final rule entitled, Medicare and Medicaid Programs; Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction; Fire Safety Requirements for Certain Dialysis Facilities; Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care. This final rule reforms Medicare regulations that are identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers. This final rule also increases the ability of health care professionals to devote resources to improving patient care by eliminating or reducing requirements that impede quality patient care or that divert resources away from furnishing high quality patient care. Additionally, this rule updates fire safety standards for Medicare and Medicaid participating End-Stage Renal Disease (ESRD) facilities by adopting the 2012 edition of the Life Safety Code and the 2012 edition of the Health Care Facilities Code. Finally, this final rule updates the requirements that hospitals and Critical Access Hospitals (CAHs) must meet to participate in the Medicare and Medicaid programs. These requirements are intended to conform to current standards of practice and support improvements in quality of care, reduce barriers to care, and reduce some issues that may exacerbate workforce shortage concerns.
• On September 27, 2019, FDA issued guidance entitled, Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Manufactured from Active Pharmaceutical Ingredients Considered to be Soluble in Aqueous Media. This draft guidance describes how the FDA intends to evaluate requests for waiving the requirement for performing in vivo bioequivalence studies for animal drugs administered orally as soluble powders or as Type A medicated articles manufactured from active pharmaceutical ingredients considered to be soluble in aqueous media.

Event Notices

• October 2, 2019: The Department of Health and Human Services (HHS) announced a public meeting entitled, Meeting of the Secretary’s Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030. The meeting will be held online via webinar and is open to the public. The Committee will discuss the nation’s proposed health promotion and disease prevention objectives and will provide recommendations to improve health status and reduce health risks for the nation by the year 2030. The Committee will discuss the role of data partnerships and deliberate recommendations for establishing data partnerships for implementing and achieving the Healthy People 2030 objectives. Pursuant to the Committee’s charter, the Committee’s advice must assist the Secretary in reducing the number of objectives while ensuring that the selection criteria identifies the most critical public health issues that are high-impact priorities supported by current national data.
• October 11, 2019: The Health Resources and Services Administration (HRSA) announced a public meeting entitled, Advisory Committee on Interdisciplinary, Community-Based Linkages. The Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL) provides advice and recommendations to the Secretary of HHS on policy, program development, and other matters of significance concerning activities under sections 750 – 760, Title VII, Part D of the Public Health Service Act. At this meeting, ACICBL members will discuss issues related to the pending Committee reports.
• October 16-17, 2019: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Meeting of the Community Preventive Services Task Force (CPSTF). The CPSTF is an independent, nonfederal panel whose members are appointed by the CDC Director. CPSTF members represent a broad range of research, practice, and policy expertise in prevention, wellness, health promotion, and public health. Matters proposed for discussion during the upcoming meeting include: Cancer Prevention and Control; Obesity Prevention and Control; Pregnancy Health; and Tobacco Cessation.
• October 21, 2019: HHS announced a public meeting entitled, Advisory Council on Alzheimer’s Research, Care, and Services. During the meeting, the Advisory Council will welcome six new members, and discuss ways to increase access to long-term services and supports that support people with dementia and their caregivers in their homes and the community including innovative state programs. Federal workgroups will also provide updates on work completed in the last quarter, as well as an overview of the 2019 Update to the National Plan to Address Alzheimer’s Disease.
• October 31, 2019: FDA announced a public meeting entitled, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Global Meeting on E8(R1) Guideline on General Considerations for Clinical Trials. The purpose of the meeting is to provide information on the draft revised E8(R1) Guideline “General Considerations for Clinical Trials” (ICH E8 Guideline) following the closing of the FDA comment period and closing of the regional consultations conducted in other ICH regions. The ICH E8 Guideline is being revised to provide updated guidance that is both appropriate and flexible enough to address the increasing diversity of clinical trial designs and data sources being employed to support regulatory and other health policy decisions, while retaining the underlying principles of human subject protection and data quality.
• November 5-6, 2019: HRSA announced a public meeting entitled, Meeting of the National Advisory Council on Nurse Education and Practice. During meeting, NACNEP will welcome new members to the Council and discuss strategic priorities for nursing education and practice in preparation for the development of the Council’s 17th Report to Congress.
• November 6-7, 2019: CDC announced a public meeting entitled, Clinical Laboratory Improvement Advisory Committee. The agenda will include agency updates from CDC, the Centers for Medicare & Medicaid Services (CMS), and FDA. Presentations and discussions will focus on a follow up on CLIAC recommendations; an update on the clinical laboratory workforce; improving integration of laboratory information systems with electronic health records; and future CLIAC topics. There will be an extended public comment session focusing on emerging technologies and the clinical laboratory. Agenda items are subject to change as priorities dictate.
• November 7, 2019: FDA announced a public meeting entitled, Promoting Effective Drug Development Programs: Opportunities and Priorities for the Food and Drug Administration's Office of New Drugs. The purpose of the meeting is to solicit specific, actionable policy suggestions that could be implemented in the near-term by the review staff of the Center for Drug Evaluation and Research's Office of New Drugs to promote effective drug development programs without compromising FDA regulatory standards for the assessment of safety and effectiveness.
• November 13-14, 2019: HHS announced a public meeting entitled, Meeting of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment. The purpose of the meeting is to discuss issues related to the President’s initiative on “Ending the HIV Epidemic: A Plan for America,” building community capacity, strategies for engaging people with HIV who are out of care, models of clinical care, workforce issues, pre-exposure prophylaxis services in community health centers, and pending committee reports.

II. Congressional Hearings

House of Representatives

• On September 24, 2019, the House Committee on Oversight and Reform Subcommittee on Economic and Consumer Policy held a hearing entitled, Don’t Vape: Examining the Outbreak of Lung Disease and CDC’s Urgent Warning Not to Use E-Cigarettes. Witnesses present included: Dr. Anne Schuchat, Principal Deputy Director, CDC; Ruby Johnson, Parent; Dr. Ngozi Ezike, Director, Illinois Department of Health; Dr. Albert Rizzo, Chief Medical Director, American Lung Association; and Vicki Porter, Minority Witness.
• On September 25, 2019, the House Committee on Energy & Commerce Subcommittee on Oversight and Investigations held a hearing entitled, Sounding the Alarm: The Public Health Threats of E-Cigarettes. Witnesses present included: Dr. Norman E. Sharpless, Acting Commissioner, FDA; Anne Dr. Schuchat, Principal Deputy Director, CDC; Dr. Joneigh Khaldun, Chief Deputy Director for Health and Chief Medical Executive, Michigan Department of Health and Human Services; Dr. Elizabeth Cuervo Tilson, State Health Director and Chief Medical Officer, North Carolina Department of Health and Human Services; Dr. Lee Norman, Secretary, Kansas Department of Health and Environment; and Dr. Monica Bharel, Commissioner, Massachusetts Department of Public Health.
• On September 25, 2019, the House Committee on Energy & Commerce Subcommittee on Health held a hearing entitled, Making Prescription Drugs More Affordable: Legislation to Negotiate a Better Deal for Americans. Witnesses present included: Robert Fowler, Ph.D., Professor Emeritus, Baldwin Wallace University; Benedic Ippolito, Ph.D., Research Fellow in Economic Policy Studies, American Enterprise Institute (AEI); and Gerard Anderson, Ph.D., Professor, Johns Hopkins Bloomberg School of Public Health (Johns Hopkins).
• On September 25, 2019, the House Committee on Appropriations Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies held a hearing entitled, Investments in Medical Research at Five Institutes and Centers of the National Institutes of Health. Witnesses present included: Dr. Francis Collins, Director, National Institutes of Health; Dr. Christopher Austin, Director, National Center for Advancing Translational Sciences; Dr. Patricia Flatley Brennan, Director, National Library of Medicine; Dr. Helene Langevin, Director, National Center for Complementary and Integrative Health; Dr. Eliseo Perez-Stable, Director, National Institute on Minority Health and Health Disparities; and Dr. Bruce Tromberg, Director, National Institutes of Biomedical Imaging and Bioengineering.
• On September 26, 2019, the House Education and Labor Committee Subcommittee on Health, Employment, Labor, and Pensions held a hearing entitled, Making Health Care more Affordable: Lowering Drug Prices and Increasing Transparency. Witnesses present included: Frederick Isasi, J.D., Executive Director, Families USA; Bari Talente, J.D., Executive Vice President, Advocacy, National Multiple Sclerosis Society; Dr. Mariana P. Socal, MD, MS, MPP, Ph.D., Assistant Scientist, Johns Hopkins Bloomberg School of Public Health, Department of Health Policy and Management; Christopher Holt, Director of Health Care Policy, American Action Forum; Craig Garthwaite, Associate Professor of Strategy, Northwestern University Kellogg School of Management; and David Mitchell, Founder, Patients for Affordable Drugs Now.

U.S. Senate

• On September 25, 2019, the Senate Committee on Aging held a hearing entitled, Promoting Healthy Aging: Living Your Best Life Long Into Your Golden Years. Witnesses present included: Dr. Rudolph Tanzi, Director, Genetics And Aging Research Unit At Massachusetts General Hospital, And Professor Of Neurology, Harvard; Susan Hughes, DSW, Co-Director, Center For Research On Health And Aging, University of Illinois-Chicago; Diane Dickerson, CEO, Bangor YMCA; and Brian Long, Lead Coordinator, Pennsylvania Link To Aging And Disability Resources Service Area 13 & Volunteer Representative, Southcentral Regional Council On Aging.

III. Reports, Studies, & Analyses

• On September 23, the House Ways and Means Committee released a report on international drug pricing entitled, A Painful Pill to Swallow: U.S. vs. International Prescription Drug Prices. This report examines patterns of drug pricing in the U.S. relative to other international comparator countries through a six-part analysis examining price differentials among 79 drugs sold in 11 countries and the U.S. in 2017 and 2018. The non-U.S. comparators in the analysis included the United Kingdom, Japan, Ontario, Australia, Portugal, France, the Netherlands, Germany, Denmark, Sweden, and Switzerland.
• On September 24, Kaiser Family Foundation (KFF) released an issue brief entitled, Recent Medicaid/CHIP Enrollment Declines and Barriers to Maintaining Coverage. Recently, there have been declines in Medicaid and CHIP enrollment, reversing a previous trend of increases following implementation of the ACA. Administrative data from CMS show that total Medicaid and CHIP enrollment declined by 2.4 million, from 74.6 million enrollees in December 2017 to 72.2 million enrollees in June 2019. This brief reviews current rules and state processes related to renewal and periodic eligibility reviews and discusses potential process issues that may be contributing to Medicaid and CHIP enrollment declines.
• On September 25, KFF released the analysis of its 2019 Employer Health Benefits Survey. This annual survey of employers provides a detailed look at trends in employer-sponsored health coverage, including premiums, employee contributions, cost-sharing provisions, offer rates, wellness programs, and employer practices. The 2019 survey included 2,012 interviews with nonfederal public and private firms.
• On September 26, the USC-Brookings Schaeffer Initiate for Health Policy released an analysis entitled, California Saw Reduction in Out-of-Network Care from Affected Specialties After 2017 Surprise Billing Law. This study observes a modest shift toward claims from in-network service providers across all the affected specialties timed to the surprise billing law’s implementation, and does not see similar changes for emergency medicine, which was unaffected by the law. Authors of the study claim that because these shifts toward in-network care are consistent across the affected specialties, this contradicts the California Medical Association claim of widespread diminishing network breadth.

IV. Other Health Policy News

• On September 25, the full statutory text of Senator Chuck Grassley’s (R-IA) drug-pricing bill was released. The text mirrors the Chairman’s mark that passed the Finance Committee in July with a bipartisan, two-thirds majority. According to Inside Health Policy, Senator Grassley is calling on both President Donald Trump and Senate Majority Leader Mitch McConnell (R-KY) to drive forward floor action on the drug pricing package. He said doing so would help the GOP maintain control of the Senate in 2020. Legislative text can be found here.