Government Shutdown: An agreement was reached and those parts of the federal government that were shut down will reopen today. The agreement is good until Feb. 15. As a reminder, the only portion of the U.S. Department of Health and Human Services (HHS) impacted by this is the Food and Drug Administration (FDA). Otherwise, HHS agencies, including the Centers for Medicare and Medicaid Services (CMS), are funded through the fiscal year, which ends September 30.
This Week: Congress begins hearings on drug issues; Ways and Means focuses on preexisting conditions.
- Ways and Means Chairman Schedules Hearing Next Week on Preexisting Conditions
- Bipartisan Introduction of Cadillac Tax Repeal Bill in 116th Congress
Ways and Means Chairman Schedules Hearing Next Week on Preexisting Conditions
The House Ways and Means Committee Chairman Richard Neal (D-MA) announced a hearing on protecting individuals with preexisting conditions to be held on Jan. 29. The hearing is the first for the Ways and Means Committee since the Democrats gained the majority in the House. This hearing also begins their work on how to stabilize the marketplace.
Find details for the hearing here.
Bipartisan Introduction of Cadillac Tax Repeal Bill in 116th Congress
On Jan. 24, a bipartisan effort out of the House reintroduced legislation to fully repeal the 40 percent excise tax on high-cost health plans, known as the “Cadillac tax.”
The Middle Class Health Benefits Tax Repeal Act is led by Reps. Joe Courtney (D-CT) and Mike Kelly (R-PA), with Reps. Suzan DelBene (D-WA) and Elise Stefanik (R-NY) also signing on as original sponsors. In the last Congress, more than 300 representatives and 33 senators from both parties cosponsored a similar Cadillac tax repeal bill.
Read and monitor H.R. 748 here.
Senate Finance and House Oversight Committees to Hold Drug-Pricing Hearing on Same Day
Senate Finance Committee Chair Chuck Grassley (R-IA) will hold a drug-pricing hearing on Jan. 29, the same day the House Oversight Committee will also hold a hearing on the same topic. Grassley reintroduced bills with Sen. Amy Klobuchar (D-MN) early this month to ban pay-for-delay patent settlements between brands and generics and to permit Canadian drug imports.
Find details for the Senate Finance Committee hearing here.
Find details for the House Oversight Committee hearing here.
FDA: Final Guidance on 510(k) Reform Plans
On Jan. 22, the Food and Drug Administration (FDA) published final guidance for a framework to install objective performance criteria in the Abbreviated 510(k) process, for certain devices. The changes to the 510(k) process include introducing objective performance criteria and encouraging medical device makers to use younger predicates in applications. The FDA reopened public comments on how to encourage medical device manufacturers to follow these changes. While the device industry expressed concern over the reforms initially shared in Nov. 2018, the FDA maintains its rationale for the proposed guidance.
Read the final guidance here.
While the public comment closing date has not been updated, comments can currently be received here.
GAO: Medicare; Voluntary and Mandatory Episode-Based Payment Models and Their Participants
On Jan. 22, the Government Accountability Office (GAO) released a report on Medicare testing alternatives to the way it pays the hospitals and physicians who provide health care services. The report reviewed tests of models that pay per “health care episode,” such as a hospitalization for surgery.
The GAO found advantages to using either voluntary or mandatory participants in these tests. Volunteers are motivated to do well, which can help Medicare determine whether a novel payment approach could work. Mandatory participation, however, allows Medicare to test with a more diverse group of participants.
Read the full report here.