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 6, 2018, the Food and Drug Administration (FDA) issued guidance entitled, Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment; Draft Guidance for Industry; Availability. This guidance addresses the clinical endpoints acceptable to demonstrate effectiveness of drugs for medication-assisted treatment of opioid use disorder. FDA is also requesting comments on when the use of placebo or active controls is most appropriate in clinical trials for such drugs.
• On August 8, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Adoption of Methodology for HHS-Operated Permanent Risk Adjustment Program for 2018 Benefit Year. This rule proposes to adopt the risk adjustment methodology that the Department of Health and Human Services (HHS) previously established for the 2018 benefit year. In February 2018, a district court vacated the use of statewide average premium in the HHS-operated risk adjustment methodology for the 2014 through 2018 benefit years. HHS is proposing to adopt the HHS-operated risk adjustment methodology for the 2018 benefit year as established in the final rules published in the March 23, 2012 Federal Register and the December 22, 2016 Federal Register.
• On August 9, 2018, CMS issued a proposed rule entitled, Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations - - Pathways to Success. Under the Medicare Shared Savings Program (Shared Savings Program), providers of services and suppliers that participate in an Accountable Care Organization (ACO) continue to receive traditional Medicare fee-for-service (FFS) payments under Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements. The policies included in this proposed rule would provide a new direction for the Shared Savings Program by establishing pathways to success through redesigning the participation options available under the program to encourage ACOs to transition to two-sided models (in which they may share in savings and are accountable for repaying shared losses). These proposed policies are designed to increase savings for the Trust Funds and mitigate losses, reduce gaming opportunities, and promote regulatory flexibility and free-market principles. The proposed rule also would provide new tools to support coordination of care across settings and strengthen beneficiary engagement; ensure rigorous benchmarking; promote interoperable electronic health record technology among ACO providers/suppliers; and improve information sharing on opioid use to combat opioid addiction.
• On August 9, 2018, CMS issued a notice entitled, Medicaid Drug Rebate Program Notice: For Participating Drug Manufacturers; Revision to the Line Extension Unit Rebate Amount Calculation. This notice announces CMS’ intent to modify the rebate system in accordance with the Bipartisan Budget Act of 2018. The notice specifically focuses on the rebate calculation for line extension drugs.

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 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 10, 2018, the HHS Office of Inspector General (OIG) issued a report entitled, Medicare Part B Drug Payments: Impact of Price Substitutions Based on 2016 Average Sales Prices. The OIG found that CMS lowered Part B reimbursement for 16 drugs; CMS’ price-substitution policy saved Medicare beneficiaries $13.1 million over a year; and Medicare and its beneficiaries could have saved up to an additional $2.7 million over 1 year if CMS implemented a more expansive price-substitution policy that, for example, allowed substitution for drugs that exceed the five percent threshold in a single quarter.

IV. Other Health Policy News

• On August 7, 2018, CMS announced that Medicare Advantage plans will have the choice of implementing step therapy to manage Part B drugs beginning January 1, 2019. Additional information is available here.

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