General Publications August 17, 2018

Alston & Bird Healthcare Week in Review, August 17, 2018

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 14, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a notice entitled, Application from the Joint Commission for Continued Approval of its Psychiatric Hospital Accreditation Program. The notice acknowledges the receipt of an application from the Joint Commission for continued recognition as a national accrediting organization for psychiatric hospitals that wish to participate in the Medicare or Medicaid programs.
  • On August 16, 2018, the Food and Drug Administration (FDA) issued guidance entitled, Process to Request a Review of Food and Drug Administration’s Decision Not to Issue Certain Export Certificates for Devices. FDA is issuing this draft guidance to comply with changes to the Federal Food, Drug, and Cosmetic Act as amended by the FDA Reauthorization Act of 2017 (FDARA), to specify the process afforded to persons denied a Certificate to Foreign Government (CFG) for a device. This draft guidance describes the information that the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) will provide to a person whose request for a CFG for a device is denied, and the process for seeking review of such a denial. This draft guidance is not final nor is it in effect at this time.
  • On August 16, 2018, the FDA issued a rule entitled, Medical Devices and Device-Led Combination Products: Voluntary Malfunction Summary Reporting Program for Manufacturers. As required by the FDARA, the FDA has identified a list of accessories for which the FDA believes general controls alone are sufficient to provide reasonable assurance of safety and effectiveness, so the accessories could be in class I. FDA is publishing this document proposing to classify these accessories into class I and distinct from other devices, as well as seek public comment in accordance with procedures established by FDARA. This document does not represent FDA's final determination with respect to the proposed accessories listed in this document.
  • On August 16, 2018, CMS issued a transmittal entitled, Current Medicare Coverage of Diabetes Supplies. This special edition article, which does not make any policy changes, presents a current overview of the diabetes supplies covered by Medicare Parts B and D to assist physicians, providers, suppliers, and other health care professionals who provide diabetic supplies to Medicare beneficiaries

Event Notices   

  • August 20, 2018: The CMS announced the annual meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) for 2018. The purpose of the Panel is to advise the HHS Secretary on the clinical integrity of the Ambulatory Payment Classification groups and their associated weights as well as hospital outpatient therapeutic services supervision issues.
  • August 21, 2018: The FDA announced a public work shop entitled, Development of Non-Traditional Therapies for Bacterial Infections. The purpose of the workshop is to discuss the general development considerations of non-traditional therapies, including pre-clinical development, early clinical studies, and phase 3 clinical trial designs to evaluate safety and efficacy.
  • 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 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 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 15, 2018, the Centers for Disease Control and Prevention issued new data on the opioid crisis. The data showed, among other things, the reported and predicted provisional counts of death due to drug overdose occurring nationally. In 2017, there were over 69,000 reported drug overdose deaths in the United States. Additional information is available here.

IV. Other Health Policy News

Media Contact
Nicholas Clarke
Senior Communications Manager
Phone: 212.210.1222
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