I. Regulations, Notices, & Guidance
- On August 24, 2016 the Food and Drug Administration (FDA) issued a final guidance entitled Industry and Food and Drug Administration Staff – Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications. This guidance helps provide greater clarity for FDA reviewers and industry regarding the principal factors FDA considers when making benefit-risk determination during the premarket preview process for certain medical devices.
- On August 23, 2016, CMS issued a Notice soliciting public comment on a collection of standardized assessment-based data items developed under the Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act). These data items meet the IMPACT Act domains of cognitive function and mental status; special services, treatments, and interventions; medical condition and co-morbidities; and impairments. CMS is seeking comment on whether the items have the potential for improving quality, the utility of the items for describing case mix, the feasibility of the items for use in post-acute care settings, and the validity of the items. Public comment is open from August 12th through September 12, 2016.
- September 21, 2016: CMS will hold a meeting of the Advisory Panel on Outreach and Education (APOE) on September 21, 2016. Specifically, the Panel will discuss Affordable Care Act initiatives.
II. Congressional Legislation & Committee Action
- The Senate has adjourned and will reconvene on Tuesday, September 6, 2016.
House of Representatives
- The House has adjourned and will reconvene on Tuesday, September 6, 2016.
III. Reports, Studies, & Analyses
- On August 24, 2016, the Department of Health and Human Services (HHS) issued a report entitled Consumers Will Still Have Affordable Options Even As Premiums Rise. The report states that even if health insurance rates increased by 25 percent nationwide, around three-fourths of exchange customers could still find plans for less than $75 a month.
- On August 24, 2016, the Congressional Budget Office (CBO) released a report entitled An Update to the Budget and Economic Outlook: 2016 to 2026. According to the latest projections made by the CBO, Medicare spending is projected to account for more than half of the increase in federal health spending in FY 2016. Federal spending for the major healthcare programs is projected to jump $77 billion in 2016, or about 8 percent.
- On August 22, 2016, the FDA filed a report entitled Eighth Annual Report on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2015. The report includes the following information: the number of abbreviated new drug applications, 505(b)(2) applications, and biosimilar biological product applications approved during the reporting period; the number of such applications that were delayed by 505(q) petitions; the number of days by which the applications were delayed; and the number of 505(q) petitions that were submitted during the reporting period.
IV. Other Health Policy News
- On August 23, 2016, Avalere Health, in conjunction with the Council for Affordable Health Care Coverage, released an analysis, which projects that 10.1 million individuals will be enrolled in an exchange plan by the end of 2016.
- On August 23, 2016, insurance startup Oscar Insurance Corp. announced that it will pull out of two markets next year. Oscar CEO Mario Schlosser said in a statement, “The individual market isn’t working as intended and there are weaknesses in the way it’s been set up.” Mr. Schlosser added, “We want to focus on the markets we understand well, we want to focus on the market where we have our own model in place.
- On August 22, 2016, the FDA announced that an agreement had been reached, in principle, on proposed recommendations for the fourth reauthorization of a medical device user fee program. Under the new draft agreement, the FDA would be authorized to collect $999.5 million in user fees plus adjustments for inflation over five years starting in October 2017. Details of the draft agreement will be published for the public in the coming weeks, and the final recommendations are scheduled to be delivered to Congress in January 2017.
- On August 22, 2016, CMS released FAQs for Federally-facilitated Marketplace (FFM) User Fee Adjustment Submission Requirements Document. The FAQs are intended to assist issuers and Third-Party Administrators with navigating the submission requirements and understanding the mechanism through which CMS will apply the FFM user fee adjustment to FFM issuers.