- 340B: Finalized wide-ranging 340B omnibus guidance now is due for release in December 2016, representing a delay from the previously anticipated September 2016 target date. A proposal that would outline an administrative dispute resolution process to resolve claims raised by covered entities that they have been overcharged for drugs purchased under the 340B Program is targeted for September 2016. A final rule imposing penalties on drug manufacturers who intentionally charge a covered entity a price above the 340B ceiling price is slated for November 2016.
- Part B Drug Payment Model: CMS lists a target of March 2019 for the proposal’s finalization. However, the three-year timeframe likely does not indicate CMS’ actual intention to delay the Model’s finalization for three years. Instead, it appears to reflect CMS’ decision to default to listing the statutory maximum timeframe for the agency to finalize a proposed rule pursuant to the requirements imposed by the MMA. Under section 902 of the MMA, CMS must finalize proposals within three years or re-propose them.
- Critical Access Hospitals: Scheduled for release in May 2016 is a proposal that would update the requirements that hospitals and Critical Access Hospitals (CAHs) must meet to participate in the Medicare and Medicaid programs.
- Medicaid Supplemental Payments: The proposal, slated for release in November 2016, would impose new reporting requirements for states to provide to CMS certain information on supplemental payments to Medicaid providers, including supplemental payments approved under either Medicaid state plan or demonstration authority.
- Medicaid DSH Allotment Reductions: Notice of proposed rulemaking is expected in January 2017 for a rule that would implement statutory reductions to state Medicaid DSH allotments from FY 2014 through FY 2020.
- MACRA MIPS and APMs: A proposal to implement provisions of the Medicare Access and CHIP Reauthorization Act (MACRA) related to MIPS and APMs is expected for finalization in November 2016 pursuant to statutory requirements.
- Generic Drug Labeling : A final rule on “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products,” which would allow label updates in advance of FDA review of the change, now is delayed until April 2017, according to the projected target date.
- Buprenorphine: The agency’s proposed rule on lifting DATA Act caps on the number of patients that physicians may treat with buprenorphine is slated for final rulemaking in September 2016.
- Confidentiality of Substance Abuse Records: A final rule is expected on 42 CFR Part 2 by SAMHSA’s November 2016 target date.
If you like what you see here, get a FREE 30-DAY all-access pass to Healthcare Lighthouse. Lighthouse Beacon will elevate and illuminate your understanding of Federal health policy, at an unbeatable price. TRY IT FREE FOR 30 DAYS.
Not only will you unlock access to all components of our site, including ACA Explained, CRS Vault, LightSearch and the Event Calendar, you’ll get a daily snapshot of the key press clips, regulatory updates and other developments driving your day through LightNews Daily.View More
Did You Know?
Healthcare Lighthouse tracks healthcare policy in 200 different topic categories!