Alston & Bird’s Week in Review provides a synopsis of the latest news in health care 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 27, 2018, the Department of Veterans Affairs (VA) issued a notice entitled, Cost-Based and Inter-Agency Billing Rates for Medical Care or Services Provided by the Department of Veterans Affairs. This document updates the Cost-Based and Inter-Agency billing rates for medical care or services provided by the VA furnished in certain circumstances.
- On August 27, 2018, the Food and Drug Administration (FDA) issued a notice entitled, List of Bulk Drug Substances for Which There is a Clinical Need under the Federal Food, Drug, and Cosmetic Act. The FDA is developing a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on the 503B Bulks List qualify for certain exemptions from the Federal Food, Drug, and Cosmetic Act (FD&C Act) provided certain conditions are met. This notice identifies three bulk drug substances that FDA has considered and is proposing not to include on the list: bumetanide, nicardipine hydrochloride, and vasopressin. Additional bulk drug substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of future notices.
- On August 29, 2018, the FDA issued a notice entitled, Development of a Shared System Risk Evaluation and Mitigation Strategy; Draft Guidance for Industry; Availability; Reopening of the Comment Period. The FDA is reopening the comment period for the notice of availability for "Development of a Shared System Risk Evaluation and Mitigation Strategy; Draft Guidance for Industry," published in the Federal Register of June 1, 2018. The FDA has received a request for an extension of the comment period for the draft guidance.
Event Notices
- September 4, 2018: the FDA announced a public hearing on FDA’s approach to enhancing competition and innovation in the biological products marketplace, including by facilitating greater availability of biosimilar and interchangeable products.
- September 10-11, 2018: The Health Resources and Services Administration (HRSA) announced a meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD). The ACTPCMD will discuss oral health training programs and finalize its recommendations on funding and appropriate levels to be included in its report.
- September 12, 2018: The FDA announced a public hearing to solicit comments on FDA’s Predictive Toxicology Roadmap, which was issued by FDA on December 6, 2017. FDA is seeking comments on how to foster the development and evaluation of emerging toxicological methods and new technologies and incorporate these methods and technologies into regulatory review.
- September 12, 2018: The FDA announced a public meeting of the Pharmacy Compounding Advisory Committee (PCAC). The PCAC will receive information on balancing the criteria for the 503A bulk drug substance evaluation and compounding as it relates to dietary supplements.
- September 20, 2018: The FDA announced a public meeting entitled, Expanding Access to Effective Treatment for Opioid Use Disorder: Provider Perspectives on Reducing Barriers to Evidence-Based Care. The meeting is intended to generate discussion with providers and health system stakeholders on the armamentarium of medications to treat opioid use disorder, current barriers to appropriate use of these medications, opportunities to reduce stigma, and methods to expand access to effective pharmacotherapies.
- September 25-26, 2018: The FDA announced a public meeting of the Pain Management Best Practices Inter-Agency Task Force. The Task Force will discuss updates to existing best practices and recommendations based on gaps and inconsistencies for pain management, including chronic and acute pain.
- September 28, 2018: The FDA announced a conference entitled, Scientific Conference: Opioid and Nicotine Use, Dependence, and Recovery – Influences of Sex and Gender. The purpose of the conference is to discuss the biological and sociological influences on misuse, abuse, and cessation of opioids and tobacco.
- November 5, 2018: The FDA announced a public hearing and an opportunity for public comment on the future format of the National Drug Code (NDC). FDA is seeking input from a variety of stakeholders through comments and responses to FDA questions included in the above notice and associated web content that will be published before the hearing.
II. Congressional Legislation & Committee Action
U.S. Senate
- No health-related hearings this week.
House of Representatives
- No health-related hearings this week.
III. Reports, Studies, & Analyses
- On August 29, 2018, The Centers for Disease Control and Prevention (CDC) released a survey entitled, Health Insurance Coverage: Early Release of Estimates From the National Health Interview Survey, January - March 2018. The survey contains CDC’s most recent health insurance coverage data. The data showed that in the first 3 months of 2018, 28.3 million (8.8 percent) people were uninsured, which is 20.3 million fewer people than in 2010.
IV. Other Health Policy News
- On August 29, 2018, CMS released a memo to Medicare Part D plans intended to improve flexibility in prescription drug choices and strengthen negotiation for Medicare enrollees. A copy of the memo that was sent to Medicare Part D plan sponsors is available here.