United States: Capitol Hill Healthcare Update - April 16, 2018


Food and Drug Administration (FDA) Commissioner Scott Gottlieb will testify Tuesday before a House appropriations subcommittee on his agency's fiscal 2019 budget – which includes the largest proposed funding increase in its history.

President Trump earlier this year proposed boosting the FDA's budget by $473 million – to nearly $3.3 billion. The FDA separately receives an additional $2.5 billion in industry user fees from pharmaceutical and medical technology manufacturers.

Gottlieb is likely to be questioned by subcommittee members on the administration's plans to lower prescription drug prices. Health and Human Services (HHS) Secretary Alex Azar is expected to present Trump later this month with a series of proposals, some of which could be new but most of which are expected to include administrative and regulatory actions already undertaken to lower drug costs.

During his congressional testimony, Gottlieb is likely to point to his agency's success in speeding generic drug approvals. The FDA last year approved 1,027 general drugs – the highest annual total in the agency's history. The FDA in 2017 also approved a record number of novel drugs and biologics, including 46 new molecular entities. More than two-thirds of those treatments were approved using an expedited review program. The FDA also had a record number of drugs with orphan indications approved, and it eliminated the entire backlog of pending orphan drug designation requests.

For medical technology, the FDA last year approved 95 new medical devices – a record number and more than four times the number of novel devices that won market approval in 2009.


The Senate Finance Committee this week will continue Congress' ongoing interest in the opioid crisis as senior HHS and the Centers for Medicare & Medicaid Services (CMS) officials are scheduled to testify before the panel.

The committee hearing will focus on opioid and substance abuse within Medicare and Medicaid. Scheduled witnesses are Adm. Brett Giroir, the HHS assistant secretary for health, and Kimberly Brandt, the principal deputy administrator for operations at CMS. Brandt also testified last week on opioid issues before a House health subcommittee.

Finance Committee Chairman Orrin Hatch (R-Utah) and the panel's top Democrat, Sen. Ron Wyden (D-Ore.), said last week they are soliciting senators for opioid-related legislative proposals to include in a future committee-backed bill.

Meanwhile, the House Energy and Commerce investigations subcommittee last week formally announced its May 8 hearing examining the opioid crisis in West Virginia, which the panel has been examining for more than a year. That hearing will feature five senior executives of drug distributors, including John Hammergren, CEO of McKesson; Steven Collis, CEO of AmerisourceBergen; George Barrett, executive board chairman of Cardinal Health; Joseph Mastandrea, chairman of Miami-Luken; and Christopher Smith, former CEO of the Smith Wholesale Drug Company.


Senate Health, Education, Labor and Pensions Committee Chairman Lamar Alexander (R-Tenn.) said his committee will vote next week on a legislative package aimed at controlling the nation's opioid crisis.

The bipartisan legislation would grant the FDA and National Institutes of Health flexibility to promote alternative pain treatments, allow nurse practitioners and physician assistants to prescribe medication-assisted treatments, and establish uniform guidelines for local opioid recovery centers. Alexander said other provisions are likely to be included in the panel's bill.

Other Senate committees also have expressed interest in opioid-related legislation, and Alexander said he wants to coordinate efforts to avoid legislation being stalled by procedural or jurisdictional issues.

Meanwhile, House Energy and Commerce Committee Chairman Greg Walden (R-Ore.) said he's confident his panel's opioid measures can be on the House floor by Memorial Day. Walden's committee is considering at least 34 different opioid bills.


HHS Secretary Alex Azar will be on Capitol Hill this week to testify before a Senate committee on his department's fiscal 2019 budget.

Azar will testify Thursday before the Senate Appropriations subcommittee on labor, health and human services, and education.

The White House earlier this year proposed $68 billion for HHS for fiscal 2019, which begins Oct. 1. Azar also is likely to receive questions about his plans to update Medicare and Medicaid payment models as well as on his efforts to reduce prescription drug prices.


A group of bipartisan members of the House Ways and Means Committee last week called on CMS to allow certain accountable care organizations (ACOs) to participate in the Medicare Shared Savings Program for a third three-year period.

Current regulations cap ACO participation at two three-year terms, and ACOs that participated during the shared savings program's inaugural year in 2012 are entering the their final year of eligibility. Extending the term of participating ACOs would encourage the program's prosperity and encourage providers to consider joint value-based payment models, the lawmakers wrote in a letter to CMS administrator Seema Verma.

The letter was signed by Reps. Suzan DelBene (D-Wash.), Earl Blumenauer (D-Ore.), Erik Paulsen, (R-Minn.), John Lewis (D-Ga.), Pat Meehan (R-Pa.), Mike Thompson (D-Calif.) and Terri Sewell (D-Ala.).


Sen. Cindy Hyde-Smith (R-Miss.) was appointed to serve on the Senate appropriations subcommittee that approves funding for HHS, FDA, CMS, and dozens of other federal health agencies and programs.

Hyde-Smith was appointed to the Senate last month by Mississippi Gov. Phil Bryant to fill the seat vacated by long-time Sen. Thad Cochran (R-Miss.), who resigned earlier this month. She was sworn in last week.

Hyde-Smith is first female lawmaker to represent Mississippi in Congress. She previously was elected as the state's commissioner of agriculture and commerce. She will compete in a special election in November to complete the balance of Cochran's term.

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