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.

Week in Review Highlight of the Week:

On Jan. 15, the Department of Health and Human Services released its draft 2020-2025 Federal Health IT Strategic Plan for public comment. Read more about the plan and other news below.

I. Regulations, Notices, & Guidance

• On January 13, 2020, the Food and Drug Administration (FDA) issued a final rule entitled, Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Wheeled Stretcher. FDA is publishing an order granting a petition requesting exemption from premarket notification (510(k)) requirements for powered wheeled stretchers (product code INK). These devices are battery-powered tables with wheels that are intended for medical purposes for use by patients who are unable to propel themselves independently and who must maintain a prone or supine position for prolonged periods because of skin ulcers or contractures (muscle contractions). This order exempts powered wheeled stretchers, class II devices, from 510(k) requirements, subject to certain conditions for exemption. This exemption from 510(k) requirements is immediately in effect for powered wheeled stretchers. FDA is publishing this order in accordance with the section of the Federal Food, Drug, and Cosmetic Act (FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).
• On January 15, 2020, FDA issued guidance entitled, Pediatric Study Plans for Oncology Drugs: Questions and Answers. This draft guidance provides information to sponsors regarding the submission of an initial pediatric study plan (iPSP), as required by the FD&C Act, for oncology drugs only. Specifically, when finalized, this draft guidance will provide FDA’s current thinking regarding iPSPs for oncology drugs in light of the amendments to the FD&C Act made by the FDA Reauthorization Act of 2017 (FDARA). FDA has received a number of questions on this topic and, as a result, is providing this draft guidance in a question and answer format, addressing the most frequently asked questions.
• On January 15, 2020, the Department of Health and Human Services (HHS) issued a final rule entitled, Annual Civil Monetary Penalties Inflation Adjustment. HHS is updating its regulations to reflect required annual inflation-related increases to the civil monetary penalties in its regulations, pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, and to make changes to reflect an amendment to the Federal Food, Drug, and Cosmetic Act by the Further Consolidated Appropriations Act, 2020 (effective January 1, 2020).
• On January 16, 2020, HHS issued a proposed rule entitled, Ensuring Equal Treatment of Faith-Based Organizations. This rule proposes changes to provide clarity about the rights and obligations of faith-based organizations participating in HHS programs, clarify HHS guidance documents for financial assistance with regard to faith-based organizations, and eliminate certain requirements for faith-based organizations that no longer reflect executive branch guidance or Supreme Court precedent. This proposed rulemaking is intended to ensure that HHS programs are implemented in a manner consistent with the requirements of federal law, including the First Amendment to the Constitution and the Religious Freedom Restoration Act.
• On January 17, 2020 , the Centers for Medicare & Medicaid Services (CMS) issued a notice of proposed rulemaking entitled, Coordinating Care from Out-of-State Providers for Medicaid Eligible Children with Medically Complex Conditions. This document is a request for information (RFI) to seek public comments regarding the coordination of care from out-of-state providers for Medicaid-eligible children with medically complex conditions. CMS wishes to identify best practices for using out-of-state providers to provide care to children with medically complex conditions; determine how care is coordinated for such children when that care is provided by out-of-state providers, including when care is provided in emergency and non-emergency situations; reduce barriers that prevent such children from receiving care from out-of-state providers in a timely fashion; and identify processes for screening and enrolling out-of-state providers in Medicaid, including efforts to streamline such processes for out-of-state providers or to reduce the burden of such processes on them. CMS intends to use the information received in response to this RFI to issue guidance to state Medicaid directors on the coordination of care from out-of-state providers for children with medically complex conditions.

Event Notices       

• January 27, 2020: HHS announced a public meeting entitled, Advisory Council on Alzheimer’s Research, Care, and Services. During the meeting, an invited panel will present lessons from epidemiology on understanding current rates of dementia, future trends, and potential preventive strategies. The Advisory Council will hear about the Department of Defense’s Peer Reviewed Alzheimer’s Research Program as well as an update on the recommendations from the Alzheimer’s Disease-Related Dementias Research Summit. Federal workgroups will also provide updates on work completed in the last quarter.
• January 28, 2020: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting entitled, Meeting of the Substance Abuse and Mental Health Services Administration’s National Advisory Council. The meeting will include remarks and dialogue from the Assistant Secretary for Mental Health and Substance Use; updates from the SAMHSA Centers Directors, and a council discussion on clinical trends and emerging national issues with SAMHSA NAC members.
• January 30-31, 2020: HHS announced a public meeting entitled, Meeting of the Advisory Committee on Minority Health. The topics to be discussed during this meeting will include strategies to improve access to and success of clinical prevention services among racial and ethnic minority populations. The recommendations will be given to the Deputy Assistant Secretary for Minority Health to inform efforts related to the Department’s community-wide, chronic disease prevention strategies.
• February 13-14, 2020: HHS announced a public meeting entitled, Meeting of the National Vaccine Advisory Committee. During the February 2020 meeting, sessions will focus on vaccine innovation and vaccine confidence with updates from subcommittees and members.
• February 24, 2020: FDA announced a public meeting entitled, Rare Disease Day 2020: Supporting the Future of Rare Disease Product Development. The goal of this meeting is to obtain stakeholders' perspectives on challenges and solutions in rare disease product development and identify commonalities that can support product development across a variety of rare diseases.
• March 4, 2020: FDA announced a public meeting entitled, Vaccines and Related Biological Products Advisory Committee. The committee will discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2020 to 2021 influenza season. Also, on March 4, 2020, under Topic II, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Respiratory and Special Pathogens (LRSP), Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, CBER.

II. Congressional Hearings

House of Representatives

• On January 14, 2020, the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled, A Public Health Emergency: State Efforts to Curb the Opioid Crisis. Witnesses present included: Jennifer Smith, Secretary, Department of Drug and Alcohol Programs (DDAP), Pennsylvania; Monica Bharel, M.D., Commissioner, Department of Public Health (DPH), Massachusetts; Christina Mullins, Commissioner, Bureau for Behavioral Health, HHS, West Virginia; Kody Kinsley, Deputy Secretary, Behavioral Health and Intellectual and Developmental Disabilities, HHS, North Carolina; and Nicole Alexander-Scott, M.D., Director, Department of Health, Rhode Island (RIDOH).
• On January 15, 2020, House Committee on Energy and Commerce Subcommittee on Health held a hearing entitled, Cannabis Policies for the New Decade. Witnesses present included: Matthew Strait, Senior Policy Advisor, Diversion Control Division, Drug Enforcement Division; Douglas Throckmorton, M.D., Deputy Director for Regulatory Programs, Center for Drug Evaluation and Research, FDA; and Nora Volkow, M.D., Director, National Institute on Drug Abuse, National Institutes of Health.

III. Reports, Studies, & Analyses

• On January 10, 2020, the Government Accountability Office (GAO) published an assessment of the Health Resources and Services Administration’s (HRSA) oversight of the 340B Drug Discount Program. In their report, entitled 340B Drug Discount Program: Increased Oversight Needed to Ensure Nongovernmental Hospitals Meet Eligibility Requirements, GAO identified several weaknesses in HRSA’s review of nongovernmental hospital contracts that are required for such providers to qualify for 340B discounts and said HRSA does not provide enough assurance that nongovernmental hospitals meet 340B eligibility requirements.
• On January 16, 2020, Kaiser Family Foundation (KFF) published an issue brief entitled, Explaining Health Care Reform: Questions About Health Insurance Subsidies. Health insurance can be expensive and is therefore often out of reach for lower and moderate-income families—particularly if they are not offered health benefits at work. To make coverage obtainable for families that otherwise could not afford it and to encourage broad participation in health insurance, the Affordable Care Act (ACA) includes provisions to lower premiums and out-of-pocket costs for people with low and modest incomes. This brief provides an overview of the financial assistance provided under the ACA for people purchasing coverage on their own through health insurance Marketplaces (also called exchanges).
• On January 17, 2020, KFF published an issue brief entitled, Medicaid: What to Watch in 2020. Medicaid, the provider of health insurance coverage for about one in five Americans and the largest payer for long-term care services in the community and nursing homes, continues to be a key part of health policy debates at the federal and state level. KFF found that key Medicaid issues to watch in 2020 include: Medicaid expansion developments; Section 1115 waiver activity; enrollment and spending trends; benefits, payment and delivery system reforms, and the implications of the 2020 elections.

IV. Other Health Policy News

• On January 15, 2020, HHS released its draft 2020-2025 Federal Health IT Strategic Plan for public comment. The draft plan outlines federal health information technology (health IT) goals and objectives to ensure that individuals have access to their electronic health information to help enable them to manage their health and shop for care. The strategic plan was developed by the HHS Office for the National Coordinator for Health Information Technology (ONC) in collaboration with more than 25 federal organizations. The federal agencies that helped to create the draft strategic plan regulate, purchase, develop, and use health IT to help deliver care and improve patient health. Through these efforts, stakeholders such as providers, payers, and researchers are increasingly using health IT tools and systems that can provide individual patients access to their health information, provide for tracking and managing of their health care treatments, and allow for interactions with their healthcare providers. Read more about the draft plan here.
• On January 15, 2020, President Trump signed an initial trade deal with China. The 86-page “Phase 1” agreement includes patent protections that could potentially spell a win for pharmaceutical companies. If China abides by the agreement, it would set up patent protections in China that are similar to U.S. law. The agreement would help protect branded drugs from generic competition while they are still under patent protection. Additionally, drugmakers could also receive a patent extension if there is a delay during the approval process. However, the agreement does not include a measure giving drugs a certain patent exclusivity period, something the industry has been pushing for in trade deals in the recent past, specifically for biologics. Read more about the deal here.

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