Healthcare Week in Review January 6, 2017

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

Healthcare Week in Review

I. Regulations, Notices, & Guidance

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.
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