General Publications September 21, 2018

Alston & Bird Healthcare Week in Review, September 21, 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 September 17, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Medicare and Medicaid Programs; Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction. This proposed rule would reform Medicare regulations that are identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers. This proposed rule is intended to increase the ability of health care professionals to devote resources to improving patient care by eliminating or reducing requirements that impede quality patient care or that divert resources away from furnishing high quality patient care.
  • On September 19, 2018, the Food and Drug Administration (FDA) issued guidance entitled, Product Identifiers under the Drug Supply Chain Security Act Questions and Answers. This draft guidance intends to clarify questions relating to product identifiers that are required by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA) for packages and homogenous cases of certain drug products. Sections of the FD&C Act require manufacturers and re-packagers to affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce beginning November 27, 2017, and November 28, 2018, respectively. This draft guidance intends to clarify these requirements.
  • On September 19, 2018, the FDA issued guidance entitled, Product Identifier Requirements under the Drug Supply Chain Security Act--Compliance Policy. This guidance describes FDA’s intention with regard to enforcement of the DSCSA provision requiring manufacturers to begin affixing or imprinting product identifiers on their products beginning November 27, 2017. This guidance finalizes the draft guidance issued on July 3, 2017.
  • On September 19, 2018, CMS issued a notice entitled, Medicare Program: Medicare Appeals; Adjustment to Amount in Controversy Threshold Amounts for Calendar Year 2019. This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2019. The calendar year 2019 AIC threshold amounts are $160 for ALJ hearings and $1,630 for judicial review.

Event Notices   

  • 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.
  • 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 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 September 18, 2018, the Senate Health, Education, Labor and Pensions Committee held a hearing entitled, Reducing Health Care Costs: Examining How Transparency Can Lower Spending and Empower Patients. Witnesses present included: Leah Binder, President and Chief Executive Officer; The Leapfrog Group; Bill Kampine, Co-Founder and Senior Vice President, Client Analytics, Healthcare Bluebook; Nancy Giunto, Executive Director, Washington Health Alliance; and Ty Tippets, Administrator, St. George Surgical Center.   

House of Representatives

  • No health-related hearings this week.

III. Reports, Studies, & Analyses

  • On September 20, 2018, 46 Brooklyn, a data analysis and research organization, issued a report entitled, What’s Happening to Generic Drug Prices? – September 2018 NADAC Survey. The report found that generic drug prices have reduced over the past year. For example, the report found that the generic Gleevec (Imatinib Mesylate) is down to $21 a pill compared to $156 last year.

IV. Other Health Policy News

  • On September 19, 2018, Health Affairs released an article entitled, Health Care Spending Under Employer-Sponsored Insurance: A 10-Year Retrospective. Using claims data from the Health Care Cost Institute, Health Affairs found that per capita spending on health services in employer-sponsored insurance plans increased by 44 percent from 2007 through 2016. According to the report, spending on outpatient services grew more quickly compared to other services.
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