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 August 19, 2019, the Food and Drug Administration (FDA) issued a notice entitled, Fit for Use Pilot Program Invitation for the Clinical Data Interchange Standards Consortium for Standard for Exchange of Nonclinical Data Implementation Guide, Version 3.1. The FDA is announcing that it intends to conduct a Fit for Use (FFU) pilot program to test the processing and analysis of nonclinical study data provided electronically for the Clinical Data Interchange Standards Consortium (CDISC) for Standard for Exchange of Nonclinical Data (SEND) Implementation Guide (IG): Version 3.1 (SEND 3.1). The Agency’s Center for Drug Evaluation and Research (CDER) will test the processing and analysis of nonclinical study data provided electronically in SEND 3.1 format. FDA is inviting individual firms that wish to participate in this pilot program to submit participation requests via email or in writing.
- On August 19, 2019, FDA issued a Request for Nominations entitled, Voting Members on a Public Advisory Committee; Blood Products Advisory Committee. FDA is requesting nominations for voting members to serve on the Blood Products Advisory Committee (the Committee) in the Center for Biologics Evaluation and Research. Nominations will be accepted for upcoming vacancies effective with this notice. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and therefore encourages nominations of appropriately qualified candidates from these groups.
- On August 20, 2019, the Drug Enforcement Administration (DEA) issued a proposed rule entitled, Schedules of Controlled Substances: Removal of 6-beta-Naltrexol from Control. The DEA proposes to remove (5a,6b)-17-(cyclopropylmethyl)-4,5-epoxymorphinan-3,6,14-triol (6b-naltrexol) and its salts from the schedules of the Controlled Substances Act (CSA). This scheduling action is pursuant to the CSA, which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. 6b-Naltrexol is currently a schedule II controlled substance because it can be derived from opium alkaloids. This action would remove the regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances, including those specific to schedule II controlled substances, on persons who handle (manufacture, distribute, reverse distribute, dispense, conduct research, import, export, or conduct chemical analysis) or propose to handle 6b-naltrexol.
- On August 22, 2019, the Department of Health and Human Services (HHS) issued a proposed rule entitled, Confidentiality of Substance Use Disorder Patient Records. This notice of proposed rulemaking proposes changes to the Confidentiality of Substance Use Disorder Patient Records regulations. These proposals were prompted by the need to continue aligning the regulations with advances in the U.S. health care delivery system, while retaining important privacy protections for individuals seeking treatment for substance use disorders. The Substance Abuse and Mental Health Services Administration (SAMHSA) strives to facilitate information exchange for safe and effective substance use disorder care, while addressing the legitimate privacy concerns of patients seeking treatment for a substance use disorder. Within the constraints of the statute, these proposals are also an effort to make the regulations more understandable and less burdensome.
- September 9-11, 2019: The Health Resources & Services Administration (HRSA) announced a public meeting entitled, National Advisory Committee on Rural Health and Human Services. The National Advisory Committee on Rural Health and Human Services (NACRHHS) provides advice and recommendations to the Secretary of HHS on policy, program development, and other matters of significance concerning both rural health and rural human services. During the September 9, 2019, through September 11, 2019, meeting, NACRHHS will examine the current delivery of health care and human services in rural areas. Agenda items are subject to change as priorities dictate. Refer to the NACRHHS website for any updated information concerning the meeting.
- September 11-12, 2019: FDA announced a public workshop entitled, Food and Drug Administration Science Forum 2019. The purpose of the public workshop is to share with the public the unique scientific research and collaborative efforts of FDA’s 11,000 scientists and researchers, who use novel science and technologies to inform FDA’s regulatory decision-making and drive innovation.
- September 18, 2019: FDA announced a public workshop entitled, Implementing the Food and Drug Administration’s Predictive Toxicology Roadmap. The purpose of this public workshop is to highlight the work FDA has been doing to support and implement FDA’s Predictive Toxicology Roadmap.
- September 26, 2019: FDA announced a public meeting entitled, Joint Pediatric Advisory Committee and Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. During the meeting, committee members will discuss the pediatric-focused safety review for OxyContin (oxycodone hydrochloride) extended-release tablets, as mandated by the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), and to discuss pediatric data considerations for opioid analgesics labeling and Pediatric Research Equity Act studies for opioids generally, using Opana IR as an example.
- 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.
- 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 public 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 (CDER's) Office of New Drugs to promote effective drug development programs without compromising FDA regulatory standards for the assessment of safety and effectiveness.
There were no health-related hearings this week.
III. Reports, Studies, & Analyses
- On August 19, 2019, the Urban Institute released a report entitled, Decomposing Trends in U.S. Health Care Spending Among Nonelderly Adults, 2007-2016. Using the 2007 to 2016 Medical Expenditure Panel Survey–Household Component, this study analyzes trends in per capita health expenditures among nonelderly adults from the Great Recession to the period following full implementation of the Affordable Care Act. The authors found that the growth in total per capita spending—and specifically for prescription drug and emergency room spending—from 2007-2009 to 2014-2016 was largely driven by increases in expenditures per unit; that is, increases in per unit prices, quality, and/or intensity of treatment. The authors also found that changes in the health insurance distribution were the largest driver behind the increase in total per capita expenditures over this period, while changes in prevalence of chronic conditions explained a smaller portion of the increase.
- On August 22, 2019, the Bipartisan Policy Center released a report entitled, Health in All Policies (HiAP): Exploring the Role of Three Federal Departments in Influencing Health. While the HHS has a substantial responsibility in advancing the health of the nation, other federal departments and agencies can also have a significant impact on disease prevention and health promotion. Health in All Policies (HiAP) is a strategy that considers the factors that influence health across all levels of policymaking to improve health outcomes. In this study, the Bipartisan Policy Center explored how three executive branch departments—the U.S. Department of Education (ED), U.S. Department of Treasury (Treasury), and U.S. Department of Labor (DOL)—currently implement a HiAP approach and how these departments can build on these efforts. The report highlights specific examples from these departments, and offers considerations and recommendations to those departments and to the Executive Office of the President of the United States to expand on this approach.
IV. Other Health Policy News
- On August 19, 2019, the Centers for Medicare & Medicaid Services (CMS) announced plans to update the quality measurement methodology of the Overall Hospital Quality Star Ratings located on the popular Hospital Compare website in 2021. In the interim, CMS will next refresh the Star Ratings using the current methodology in early 2020, ensuring patients have timely access to the most up-to-date hospital quality information while a new methodology is being finalized. More information about this announcement can be found here.
- On August 20, 2019, SAMHSA released the 2018 National Survey on Drug Use and Health (NSDUH). The annual survey is the nation’s primary resource for data on mental health and substance use among Americans. More information about the survey can be found here.
- On August 20, 2019, HHS announced nearly $107 million in Quality Improvement Awards to 1,273 health centers across nearly all U.S. states, territories and the District of Columbia. Funded by the HRSA, health centers will use these awards to improve the quality, efficiency, and value of the health care they provide. More information about this action and the recipients of the 2019 Quality Improvement Awards can be found here.
- On August 23, 2019, CMS issued guidance to states regarding how they should determine certain sponsored immigrants’ eligibility for Medicaid and the Children’s Health Insurance Program (CHIP). This guidance follows the issuance of the Presidential Memorandum on Enforcing the Legal Responsibilities of Sponsors of Aliens, which directs relevant federal agencies to update or issue procedures and guidance as needed, to ensure compliance with the sponsor deeming and repayment obligations under current law. More information about this action is available here.