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 October 2, 2018, the Food and Drug Administration (FDA) issued guidance entitled, Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs; Guidance for Industry; Availability. The guidance addresses FDA’s current thinking about the relevant age groups to study and how early in drug development applicants should incorporate pediatric patients for development of systemic drugs for atopic dermatitis.
• On October 3, 2018, the FDA issued guidance entitled, Process to Request a Review of the Food and Drug Administration's Decision not to Issue Certain Export Certificates for Devices; Extension of Comment Period. The FDA is extending the comment period for the notice of availability that appeared in the Federal Register on August 17, 2018.
• On October 4, 2018, the FDA issued guidance entitled, Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials; Draft Guidance for Industry; Availability; Correction. The FDA is correcting a document that appeared in the Federal Register on September 7, 2018. The document announced the draft guidance for industry entitled “Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbial.” The notice inadvertently contained the wrong docket number. This document corrects that error.

Event Notices   

• October 27, 2018: The FDA announced a public meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general functions of the committees is to provide advice and recommendations to the FDA on regulatory issues.
• 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.
• November 7, 2018: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC). The CLIAC will hear updates from other agencies on a range of laboratory-related issues, including laboratory interoperability.
• November 8, 2018: The FDA announced a meeting of the Vaccines and Related Biological Products Advisory Committee. The Committee will hear an overview of the research program in the Laboratory of DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review.
• November 27, 2018: The FDA announced a public meeting entitled, Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions. The purpose of the hearing is to give stakeholders the opportunity to provide input on the underlying systemic causes of drug shortages and make recommendations for actions to prevent or mitigate drug shortages.

II. Congressional Legislation & Committee Action

U.S. Senate

• On October 3, 2018, the Senate Aging Committee held a hearing entitled, Patient-Focused Care: A Prescription to Reduce Health Care Costs. Witnesses present included Dr. David Howes, President and CEO, Martin’s Point Health Care; Jeff Micklos, Executive Director, Health Care Transformation Taskforce; Sean Cavanaugh, Chief Administrative Officer, Aledade Inc.; and Rev. Sally Jo Snyder, Director of Advocacy & Consumer Engagement, Consumer Health Coalition.
• On October 3, 2018, the Senate Health, Education, Labor and Pensions Committee held a hearing entitled, Rare Diseases: Expediting Treatments for Patients. Witnesses present included: Mark Dant, Chair, EveryLife Foundation for Rare Diseases; Marc Patterson, MD, Professor of Neurology Pediatrics, and Medical Genetics, Mayo Clinic; Michael Strupp, MD, Professor of Neurology, University of Munich; Lincoln Tsang, Partner, Arnold, Porter, Kaye, Scholer LLP; and Mallory Factor, Founder and Chief Executive Officer, IntraBio, Inc.

House of Representatives

• There were no health-related hearings this week.

III. Reports, Studies, & Analyses

• On October 4, 2018, the Robert Wood Johnson Foundation released a report entitled, Marketplace Pulse: Percent of Plans with Out-of-Network Benefits. The report found that exposure to out-of-network bills is high and rising in the individual and small group markets. According to the study, only 29 percent of individual plans have out-of-network benefits. Further information is available here.

IV. Other Health Policy News

• On October 3, 2018, CMS announced revisions to the Medicare Program Integrity Manual. The changes are intended to accelerate innovation and promote patient access to medical technology. According to CMS, Medicare Administrative Contractors determine which healthcare items and services meet requirements for Medicare coverage – taking into account local variations in the practice or medicine – through local coverage determinations (LCDs). The manual changes are intended to help clarify and simplify the LCD process to help ensure companies can get therapies and devices to patients efficiently. Additional information is available here.