Below is Alston & Bird’s Healthcare 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.
I. Regulations, Notices, & Guidance
- On June 26, 2019, the Food and Drug Administration (FDA) issued guidance entitled, Marketing Clearance of Diagnostic Ultrasound Systems and Transducers. This final guidance provides detailed recommendations for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers, and includes guidance describing the types of modifications to a diagnostic ultrasound device for which FDA does not intend to enforce the requirement for a new premarket notification (510(k)).
- On June 27, 2019, FDA issued a proposed rule entitled, Biologics License Applications and Master Files. This rule proposes to amend the FDA’s regulations concerning the use of master files for biological products. This action, if finalized, will allow certain biological products approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to continue to incorporate by reference information about drug substances, drug substance intermediates, or drug products contained in master files after those products are deemed to be licensed under the Public Health Service Act (PHS Act) on March 23, 2020. The proposed rule also codifies FDA's practice of permitting applications for biological products submitted under the PHS Act to incorporate by reference information other than drug substance, drug substance intermediate, or drug product information contained in a master file. In addition, the proposed rule codifies FDA's practice of permitting investigational new drug applications to incorporate by reference any information contained in a master file for products subject to licensure under the PHS Act.
- On June 27, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Medicare and Medicaid Programs: Risk Adjustment Data Validation. This document summarizes actions taken to date, requests public comment on additional subjects, and announces that CMS is releasing additional material, including study data, related to the Risk Adjustment Data Validation (RADV) provisions of the proposed rule titled “Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Program of All-inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021” that was published in the November 1, 2018 Federal Register, 83 FR 55037.
- July 16, 2019: CMS announced a public meeting entitled, Advisory Panel on Outreach and Education. The Panel will advise and make recommendations to the Secretary of HHS and the Administrator of CMS on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP).
- July 26, 2019: FDA announced a public workshop entitled, Endpoints for Drug Development in Heart Failure. The purpose of this public meeting is to bring the stakeholder community together to discuss clinical endpoints for trials in heart failure that could be used to support FDA approval of drugs. The workshop will focus on endpoints related to symptoms and physical function. In addition, there will be discussion of the need to assess mortality effects of drugs under development for heart failure.
- July 29, 2019: HHS announced a public meeting entitled, Advisory Council on Alzheimer’s Research, Care, and Services. The Advisory Council will spend the majority of the meeting considering recommendations made by each of the three subcommittees to present to the Secretary of HHS and Congress. Additional presentations will include updates on the latest biomedical research findings, an overview of the Healthy Brain Initiative: The Road Map for Indian Country,and a discussion of the progress made since 2011 through the National Plan to Address Alzheimer's Disease. Federal workgroups will also provide updates.
- On June 26, 2019, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a markup of three bills. Legislation included: 1895, the Lower Health Care Cost Act of 2019 (LHCCA); S. 1199, Poison Center Network Enhancement Act of 2019; and S. 1173, Emergency Medical Services for Children Reauthorization Act of 2019. All three bills, as amended, were reported favorably to the Senate floor.
- On June 27, 2019, the Senate Judiciary Committee held a markup of four bills. Legislation included: S. 1227, the Prescription Pricing for the People Act of 2019; S. 1224, the Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (STALLING) Act; S. 1416, the Affordable Prescriptions for Patients Act of 2019; and S. 440, the Preserving Access to Cost Effective Drugs (PACED) Act. All four bills, as amended, were reported favorably to the Senate floor.
House of Representatives
- On June 25, 2019, the House Committee on Energy and Commerce Subcommittee on Health held a hearing entitled, Reauthorizing Vital Health Programs for American Families. Witnesses present included: Amy Hewitt, Ph.D., Director, Institute on Community Integration, University of Minnesota; Joseph Bocchini, M.D., Professor, Department of Pediatrics, Louisiana State University Health, Shreveport; Patricia Kunz Howard, Ph.D., RN, President, Emergency Nurses Association, Director, Emergency Services, University of Kentucky Healthcare; Jill Kagan, Director, ARCH National Respite Network and Resource Center.
- On June 26, 2019, the House Committee on Veterans’ Affairs Subcommittee on Health Oversight held a hearing entitled, Beyond the Million Veterans Program: Barriers to Precision Medicine. Witnesses present included: Matt Kuntz, Executive Director, National Alliance on Health Illness, Montana; Dr. Magali Haas, MD, Ph.D., CEO and President of Cohen Veterans Bioscience; and Dr. Carolyn Clancy, M.D., Deputy Under Secretary for Discovery, Education, and Affiliated Networks, Veterans Health Administration, U.S. Department of Veterans Affairs.
- On June 26, 2019, The House Ways & Means Committee held a markup of five bills. Legislation included: R. 3417, The Beneficiary Education Tools, Telehealth, and Extenders Reauthorization Act of 2019; H.R. 3429, The HEARTs and Rural Relief Act, H.R. 3436, The Improving Chronic Care Management Act; H.R. 3414, The Opioid Workforce Act of 2019; and H.R. 3439, The Protecting Access to Information for Effective and Necessary Treatment (PATIENTS) Act of 2019.
III. Reports, Studies, & Analyses
- On June 26, 2019, the Center for American Progress issued a report entitled, The High Price of Hospital Care. The study examined rising hospital rates, taking a close look at hospital profits, determinants of hospital prices, and suggested policies that could help reduce the cost of hospital care.
IV. Other Health Policy News
- On June 24, 2019, President Trump signed an Executive Order entitled Improving Price and Quality Transparency in American Healthcare to Put Patients First. The Order is intended to initiate the development of several rules aimed at improving the transparency of the American healthcare pricing system. The text of the Executive Order is available here.