Alston & Bird Healthcare Week in Review, August 24, 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 20, 2018, the Food and Drug Administration (FDA) issued guidance entitled, Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations. This guidance is intended to assist sponsors of microdose radiopharmaceutical diagnostic drugs on the nonclinical studies recommended to support human clinical trials and marketing applications.
• On August 22, 2018, the FDA issued guidance entitled, Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, and Biological Products for Treatment. The purpose of this draft guidance is to assist sponsors who are developing drugs, devices, or biological products to treat the underlying pathophysiology and structural progression of osteoarthritis (OA). This draft guidance does not address improvement of symptoms of OA, such as pain or functional impairment, which will be addressed in future guidance.
• On August 22, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a notice entitled, Medicare Program: Certain Changes to the Low-Volume Hospital Payment Adjustment under the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals for Fiscal Years 2011 through 2017. This document announces changes to the payment adjustment for low-volume hospitals under the hospital inpatient prospective payment systems (IPPS) for acute care hospitals for fiscal years (FYs) 2011 through 2017 in accordance with section 429 of the Consolidated Appropriations Act of 2018.
• On August 24, 2018, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) issued a request for information entitled, Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP. This request for information seeks input from the public on how to address any regulatory provisions that may act as barriers to coordinated care or value-based care.

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

• On August 21, 2018, the Senate Homeland Security & Governmental Affairs Committee held a hearing entitled, Examining CMS’s Efforts to Fight Medicaid Fraud and Overpayments. Witnesses present included: Seema Verma, Administrator, Centers for Medicare & Medicaid and Eugene Dodaro, Comptroller General of the United States, Government Accountability Office.
• On August 23, 2018, the Senate Health, Education, Labor, and Pensions Committee held a hearing entitled, Prioritizing Cures: Science and Stewardship at the National Institutes of Health. Francis Collins, Director of the National Institutes of Health was the only witness.

House of Representatives

• No health-related hearings this week.

III. Reports, Studies, & Analyses

• On August 24, 2018, the Government Accountability Office (GAO) released a report entitled, Medicare Fee-For-Service: Information on the First Year of Nationwide Reduced Payment Rates for Durable Medical Equipment. Historically, Medicare used a standard set of rates to pay for certain durable medical equipment for its beneficiaries. Due to concerns that it was paying higher than market rates, Medicare began a competitive bidding program for some of these items in designated areas in 2011. In 2016, information from this program was used to reduce rates in the rest of the country. GAO found that the number of suppliers who sold these items decreases – continuing a long-term trend – but that available information indicates that beneficiaries were able to get needed items.

IV. Other Health Policy News

• On August 23, 2018, the United States Senate passed the $854 billion Labor-HHS-Defense-Education bill by an 85-7 vote. The bill contained a number of health-related provisions, including an amendment giving $1 million to HHS to implement rules requiring drug companies to list prices in direct-to-consumer advertising.