Health Update (January 21)
|The Medicaid Extenders Act of 2019 is one step closer to becoming law. This week, the Senate passed H.R. 259 unanimously without amendment, sending it to President Trump’s desk. The Money Follows the Person (MFP) demonstration project and spousal impoverishment protections for Home- and Community-based Services (HCBS) recipients will be extended for three months.
House Committee Rosters
Committee assignments continue to be doled out by leadership in both parties. Energy and Commerce Chairman Frank Pallone (D-NJ) and Ranking Member Greg Walden (R-OR) have made the final assignments for subcommittee chairmanships and ranking member positions. Committee Democrats elected Representative Yvette Clarke (D-NY) as Vice Chair of the full committee. For a list of all subcommittee chairmanships and assignments for the majority, click here. For a list of subcommittee ranking members and assignments for the minority, click here.
Ways and Means Committee Chairman Richard Neal (D-MA) has also announced the membership and new chairs of the Ways and Means subcommittees for the 116th Congress. Representative Lloyd Doggett (D-TX) was named Chair of the Health Subcommittee. For a full list of subcommittee chairmanships and assignments for the majority, click here. For subcommittee ranking members and assignments for the minority, click here.
Shutdown Impact on FDA
While the government shutdown has officially become the longest in American history, agencies are working to make ends meet. Food and Drug Administration (FDA) Commissioner Scott Gottlieb tweeted this week that the agency has reduced overhead charges to the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research in order to preserve program function. Said Commissioner Gottlieb, “We’ve stretched carryover drug user fees to get a longer runway should the shutdown continue.” He estimates that the elimination of the overhead charges gives FDA approximately 5 weeks until they run out of money.
A list from the House Oversight Committee details the twelve drug companies that received a letter from Chairman Elijah Cummings (D-MD) seeking information on each companies’ pricing practices. The list, which includes Health and Human Services (HHS) Secretary Alex Azar’s former employer Eli Lilly, can be viewed here. A news release from the committee calls the pending investigation “one of the most wide-ranging investigations in decades into the prescription drug industry’s pricing practices.” Chairman Cummings and Secretary Azar had a 40 minute meeting this week, and both men agreed that they would do everything in their power to work together in a bipartisan basis. In a discussion with reporters, Chairman Cummings said that he believed he and Secretary Azar had “the same goals, but not necessarily the exact same legislation” with regard to lowering drug prices.
This morning, the Centers for Medicare and Medicaid Services (CMS) put out new information on the Part D and Medicare Advantage model. The Center for Medicare and Medicaid Innovation (CMMI) announced a new payment model and updates to an existing model to “provide seniors with more benefits while strengthening competition among plans.” It is noteworthy that the new payment model was announced via CMMI, as Ways and Means Chairman Richard Neal (D-MA) and Ranking Member Kevin Brady (R-TX) sent a letter last Wednesday to HHS requesting more transparency on the work CMMI is doing.
The FDA is taking new steps to make naloxone easier to use. A press announcement from Commissioner Gottlieb this week detailed a new Drug Facts label (DFL) for FDA-approved naloxone, which are required for over-the-counter (OTC) products. Commissioner Gottlieb called this an “unprecedented step” in increasing access to naloxone. It is the first time the FDA has used the development of a DFL to support the approval of an over-the-counter product.
A new study from the Centers for Disease Control and Prevention (CDC) revealed a disparity in opioid prescribing rates in rural areas when compared to metropolitan counties. In a study period from January 2014 to January 2015, opioid prescribing rates were “significantly higher” in nonmetropolitan counties. The study suggests that this trend might be attributed to “higher prevalences of chronic pain among persons in rural areas”, as well as the fact that rural areas tend to have “higher concentrations of older adults with increased likelihood of conditions associated with pain.” To read the full study from CDC, click here.
Affordable Care Act News
This week, CMS issued a proposed rule for Benefit and Payment Parameters in 2020. While the proposed rule does not end the practice of “silver loading” (raising premiums on silver plans to compensate for lost cost-sharing reduction payments), it seeks feedback from stakeholders on ways in which HHS might address the problem. It also seeks feedback on the practice of re-enrollment, citing concerns that automatic re-enrollment may shield consumers from changes to their coverage, which “may result in consumers being less aware of their options from year to year.” Notably, the proposed rule does propose allowing the exclusion of drug manufacturer coupons from counting toward the annual limitation on cost sharing when generics are available. The rule can be viewed here, and the public comment period for the proposed rule ends at 5:00 pm on February 19th.
 Scott Gottlieb, M.D. Twitter, 14 Jan 2019. https://twitter.com/SGottliebFDA/status/1084913705500987392
 “Oversight Committee Launches Sweeping Drug Price Investigation.” House Committee on Oversight and Reform, 14 Jan 2019. https://democrats-oversight.house.gov/news/press-releases/oversight-committee-launches-sweeping-drug-price-investigation
 CMS Announces New Model to Lower Drug Prices in Medicare Part D and Transformative Updates to Existing Model for Medicare Advantage.” Centers for Medicare and Medicaid Services, 18 Jan 2019. https://www.cms.gov/newsroom/press-releases/cms-announces-new-model-lower-drug-prices-medicare-part-d-and-transformative-updates-existing-model
 Sarah Peddicord. “Statement from FDA Commissioner Scott Gottlieb, M.D., on unprecedented new efforts to support development of over-the-counter naloxone to help reduce opioid overdose deaths.” Food and Drug Administration, 17 Jan 2019. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm629571.htm
 Macarena Garcia et al. “Opioid Prescribing Rates in Nonmetropolitan and Metropolitan Counties Among Primary Care Providers Using an Electronic Health Record System – United States, 2014-2017.” Morbidity and Mortality Weekly Report, 18 Jan 2019. https://www.cdc.gov/mmwr/volumes/68/wr/mm6802a1.htm?s_cid=mm6802a1_w
 “Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2020.” Department of Health and Human Services, 18 Jan 2019. https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-00077.pdf