A&B Healthcare Week in Review, January 6, 2017

I. Regulations, Notices, & Guidance

• On January 3, 2017, the Food and Drug Administration (FDA) issued a notice entitled, Technical Electronic Product Radiation Safety Standards Committee, Renewal. The notice announces the renewal of the Technical Electronic Product Radiation Safety Standards Committee. The Technical Electronic Product Radiation Safety Standards Committee has been renewed for an additional 2 years beyond the charter expiration date. The new charter will be in effect until December 24, 2018.
• On January 4, 2017, the Department of Health and Human Services (HHS) issued a final rule entitled, 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation. The final rule will apply to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. The final rule sets forth the calculation of the 340B ceiling price and application of civil monetary penalties (CMPs). The rule is effective on March 6, 2017.
• On January 4, 2017, the FDA issued a draft guidance entitled, Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals. The draft guidance, when finalized, will provide questions and answers on topics related to compliance, labeling of added sugars, declaration of quantitative amounts of vitamins and minerals, and format for Nutrition and Supplement Facts labels. Comments are due by March 6, 2017.
• On January 4, 2017, the FDA issued a draft guidance entitled, Reference Amounts Customarily Consumed: List of Products for Each Product Category. The draft guidance, when finalized, will provide examples of products that belong to product categories included in the tables of Reference Amounts Customarily Consumed (RACCs) per Eating Occasion established in our regulations. Comments are due by March 6, 2017.
• On January 4, 2017, the FDA issued a notice entitled, Food and Drug Administration Tribal Consultation Policy. The purpose of the FDA Tribal Consultation Policy is to further the government-to-government relationship between the FDA and American Indian and Alaskan Native Tribes (Indian Tribes) and facilitate tribal consultation with the FDA. The FDA Tribal Consultation Policy provides background on the FDA's mission and organizational structure and elaborates on the principles and guidelines in HHS Tribal Consultation Policy. The policy finalizes the draft FDA Tribal Consultation Policy issued in February 2016.
• On January 6, 2017, the Centers for Medicare & Medicaid Services (CMS) issued an extension of temporary moratoria entitled, Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Extension of Temporary Moratoria on Enrollment of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Designated Geographic Locations. CMS announced the extension of statewide temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance providers and suppliers and Medicare home health agencies, subunits, and branch locations in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey, as applicable, to prevent and combat fraud, waste, and abuse. This extension also applies to the enrollment of new non-emergency ground ambulance suppliers and home health agencies, subunits, and branch locations in Medicaid and the Children’s Health Insurance Program in those states.
• On January 6, 2017, the FDA issued a final rule entitled, Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses.” The final rule describes the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The final rule is intended to provide direction to regulated industry and to help avoid consumer confusion
• On January 6, 2017, the FDA issued a notice entitled, Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus. The notice announces the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of the Zika virus in response to the Zika virus outbreak in the Americas. The FDA issued this Authorization under the FD&C Act, as requested by ELITechGroup Inc. Molecular Diagnostics. The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The authorization is effective on December 9, 2017.
• On January 6, 2017, the FDA issued a notice entitled, Generic Drug User Fee Amendments II Program Fee: List of Abbreviated New Drug Application Sponsors and Application Numbers. The FDA is seeking information and public comment, in anticipation of the passage of Generic Drug User Fee Amendments reauthorization (GDUFA II), relevant to the FDA’s planned approach for administering generic drug program fees under that legislation for fiscal year (FY) 2018. This notice includes requests for comment and information regarding the FDA’s initial inventory of approved abbreviated new drug application sponsors and application numbers. Comments must be submitted by March 10, 2017.

Event Notices

• February 1, 2017: HHS announced a meeting of Substance Abuse and Mental Health Services Administration’s (SAMHSA) Center for Substance Abuse Treatment (CSAT) National Advisory Council (NAC). The meeting will include consideration of minutes from the SAMHSA CSAT NAC meeting of August 24, 2016, the Director’s report, a budget update, discussions of CSAT’s role translating science to service, and discussion of technology assisted care.
• February 23, 2017: The FDA announced a public advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. The committee will discuss and make recommendations on clinical information related to the de novo request for the Sentinel Cerebral Protection System, a first of a kind embolic protection device to be used with transcatheter aortic valve replacement (TAVR) procedures.
• March 6, 2017: The FDA announced a public advisory committee meeting of the Pediatric Advisory Committee (PAC). The PAC will meet to discuss pediatric-focused safety reviews.
• March 15 – 17, 2017: CMS announced the annual qualified health plan (QHP) issuer conference. The event is for issuers applying for QHP certification in the Federally-facilitated Marketplace (FFM).
• April 6, 2017: The FDA announced a public workshop entitled, Emerging Tick-Borne Diseases and Blood Safety. The purpose of the public workshop is to discuss tick-borne pathogens that continue to emerge as threats to blood safety, the effectiveness of current and potential mitigation strategies, and the general approach to decision making on blood safety interventions
• April 19 – 20, 2017: The FDA announced a public workshop on electronic nicotine delivery systems (ENDS). The 2-day public workshop will include presentations and panel discussions about ENDS battery safety concerns as well as how potential safety hazards and risks are communicated to consumers and the general public.

II. Congressional Legislation & Committee Action

U.S. Senate

• There were no healthcare related hearings this week.

House of Representatives

• There were no healthcare related hearings this week.

III. Reports, Studies, & Analyses 

• On January 4, 2017, the Office of Inspector General (OIG) released a report entitled, High-Price Drugs Are Increasing Federal Payments for Medicare Part D Catastrophic Coverage. The report found that the federal payments for catastrophic coverage exceeded $33 billion in 2015, which is more than triple the amount paid in 2010. Spending for high-price drugs contributed significantly to this growth. By 2015, high-price drugs were responsible for almost two-thirds of the total drug spending in catastrophic coverage. Moreover, the study found that 10 high-price drugs accounted for nearly one-third of all drug spending for catastrophic coverage in 2015.
• On January 4, 2017, the OIG released a report entitled, Virginia Did Not Bill Manufacturers for Some Rebates for Physician-Administered Drugs Dispensed to Enrollees of Medicaid Managed-Care Organizations. The report found that for the period January 1 through December 31, 2013, the Virginia Department of Medical Assistance Services, Division of Health Care Services (State agency), did not fully comply with Federal Medicaid requirements for billing manufacturers for some rebates for physician-administered drugs dispensed to enrollees of managed-care organizations (MCOs). The State agency properly billed manufacturers for rebates for drugs associated with the National Drug Codes (NDCs) in the OIG’s judgmental sample. However, the State agency did not have valid NDCs for other drug utilization data submitted by MCOs for physician-administered drugs, and the State agency did not bill manufacturers for rebates for these drugs. The State agency estimated average rebates per claim billed to manufacturers, and we determined these estimates to be reasonable. The OIG applied the estimates and determined that the State agency did not bill rebates of $5.8 million ($2.9 million Federal share) to manufacturers for physician-administered drug utilization without valid NDCs.

IV. Other Health Policy News

• On January 4, 2017, CMS released a Biweekly Enrollment Snapshot for weeks 8 and 9 of Open Enrollment of 2017. According to CMS, 8.8 million Americans have signed up for coverage through HealthCare.gov since Open Enrollment began on November 1st. This compares to about 8.6 million plan selections last year at this time. Total plan selections as of December 31st, which include auto reenrollments, consist of 2.2 million new consumers and 6.6 million returning consumers. Among returning consumers, two thirds, or 4.4 million, actively selected a plan, an increase from last year.
• On January 5, 2017, CMS issued an informational bulletin entitled, The Early and Periodic Screening, Diagnostic and Treatment (EPSDT) benefit for children and youth in managed care. The informational bulletin describes the flexibility states have in determining how to ensure the provision of EPSDT benefits. Specifically, beneficiaries under age 21 are entitled to EPSDT services, whether they are enrolled in a managed care plan or receive services in a fee-for-service (FFS) delivery system. In states that use managed care to deliver some or all of the services included in the EPSDT benefit, CMS states that it is important to include enough specificity in managed care plan contracts to avoid confusion about what the benefit includes and what entity is responsible for delivering it to ensure that eligible individuals under age 21 have access to the full EPSDT benefit. The informational bulletin describes three ways in which states and plans can accomplish this.
• On January 5, 2017, the CMS Center for Medicare and Medicaid Innovation (CMMI) released their third report to Congress. The report focuses on activities between October 1, 2014 and September 30, 2016, but also highlights a number of important activities started during that time period that were announced between September 30, 2016 and December 31, 2016.