Trump Expresses Strong Support for Part D Negotiations

During a press conference last Wednesday, President-Elect Donald Trump promised to force the pharmaceutical and biotechnology industries to bid for the government’s business. He offered few specific details on the policy. Negotiation of drug prices between the government and private industry is an issue which many congressional Republicans strongly oppose, including Trump’s nominee for Secretary of Health and Human Services (HHS) Rep. Tom Price (R-Ga.). Trump’s remarks were later echoed by Sen. Bernie Sanders (I-Vt.). Sen. Sanders introduced a more bipartisan proposal to address drug prices during debate on the fiscal year (FY) 2017 budget resolution last week. The amendment, introduced
with Sen. Amy Klobuchar (D-Minn.), would allow for the importation of drugs from Canada by pharmacists, wholesalers, and individuals with a valid prescription. While the amendment was not adopted by a 46-52 vote, twelve Republicans voted in favor of the measure: Sens. John Boozman (R-Ark.), Susan Collins (R-Maine), Ted Cruz (R-Texas), Jeff Flake (R-Ariz.), Chuck Grassley (R-Iowa), Dean Heller (R-Nev.), John Kennedy (R-La.), Mike Lee (R-Utah), John McCain (R-Ariz.), Lisa Murkowski (R-Alaska), Rand Paul (R-Ky.) and John Thune (R-S.D.). But 13 Democrats opposed the measure, in part due to concerns about the Food and Drug Administration’s (FDA) ability to ensure the safety of imported prescriptions. A recent report from the HHS Office of the Inspector General (OIG) found that high-price drugs are increasing federal payments for Medicare Part D catastrophic coverage. Catastrophic coverage pays for drug costs when beneficiaries’ out-of-pocket spending exceeds a certain threshold. Federal spending on catastrophic coverage has more than tripled in the past five years, from $10.8 billion in 2010 to $33.2 billion in 2015. OIG recommends that the Centers for Medicare and Medicaid Services (CMS) assess tools to address high-price drugs, such as restructuring the Part D benefit, creating transparency around drug pricing, promoting value-based options, and negotiating prices for certain drugs.

Price Promises to Sell Stocks Ahead of Nomination Hearing

Rep. Tom Price (R-Ga.), President-Elect Donald Trump’s choice to lead the U.S. Department of Health and Human Services (HHS), has vowed to divest his interests in health care companies if he is confirmed by the Senate for the cabinet position. Price has faced scrutiny in recent weeks over his stock trades in health care companies while serving on the Ways and Means Committee, which has jurisdiction over Medicare spending. In a letter to the HHS ethics office, Price also promised to resign as a delegate for the American Medical Association (AMA) if he is confirmed. Price’s first nomination hearing will be held on Wednesday before the Senate Health, Education, Labor and Pensions (HELP) Committee. According to Committee Chairman Lamar Alexander (R-Tenn.), confirmation of Price’s nomination may not come until mid-February. The extra time could be used to consult with governors about repeal and replacement of the Affordable Care Act (ACA). The Senate Finance Committee has primary responsibility for the HHS nomination, and has not yet scheduled a hearing or vote for Rep. Price.

NCI Launches New Formulary

The National Cancer Institute (NCI) announced the creation of a new drug formulary that will allow its cancer centers to more quickly access approved and experimental treatments for use in cancer research. Access to these drugs usually requires a lengthy negotiation process. The formulary was launched as a part of the Cancer Moonshot Initiative and includes 15 drugs. The National Institutes of Health (NIH) expect the formulary to speed the start of research by more than a year and a half. The public-private partnership currently includes six drug manufacturers, and additional pharmaceutical companies are still in the process of negotiating with the agency. Leaders of NIH expect the formulary to include double the number of available drugs by the end of 2017.

Trump Administration Staff Announcements

President-Elect Donald Trump has picked current Undersecretary of Health for the Veterans Health Administration (VHA) David Shulkin as his nominee for Secretary of the Veterans Affairs (VA). Shulkin would be the first VA secretary who is not a veteran. He is an internist who has previously overseen the turnaround of hospitals in the private sector, including Beth Israel Medical Center in New York. Shulkin was nominated by President Obama and confirmed for his current position in 2015. During his time at the VHA, he has advocated for more integration of private sector providers in the VA.

Upcoming Congressional Hearings and Meetings

Senate Health, Education, Labor and Pensions (HELP) Committing hearing on the nomination of Tom Price to serve as Secretary of Health and Human Services; 10:00 a.m., 430 Dirksen Bldg.; January 18

Recently Introduced Health Legislation

H.R.352 (introduced by Rep. Todd Rokita): To amend the Social Security Act to replace the Medicaid program and the Children’s Health Insurance program with a block grant to the States, and for other purposes; Energy and Commerce, Rules, Ways and Means, Education and the Workforce, Judiciary, Natural Resources, House Administration, Appropriations

H.R.365 (introduced by Rep. Erik Paulsen): To amend the Internal Revenue Code of 1986 to provide for the treatment of certain direct primary care service arrangements and periodic provider fees; Ways and Means H.Res.32 (introduced by Rep. Grace Meng): Recognizing July 28, 2017, as “World Hepatitis Day”; Energy and Commerce

H.R.370 (introduced by Rep. Bill Flores): To repeal the Patient Protection and Affordable Care Act and health carerelated provisions in the Health Care and Education Reconciliation Act of 2010, and for other purposes; Energy and Commerce, Education and the Workforce, Ways and Means, Judiciary, Natural Resources, Rules, House Administration, Appropriations, Budget

H.R.372 (introduced by Rep. Paul A. Gosar): To restore the application of the Federal antitrust laws to the business of health insurance to protect competition and consumers; Judiciary

H.Res.35 (introduced by Rep. John J. Duncan, Jr.): Expressing the sense of the House of Representatives relating to automated external defibrillator (AED) training in the Nation’s schools; Education and Workforce, Energy and Commerce

S.58 (introduced by Sen. Dean Heller): A bill to amend the Internal Revenue Code of 1986 to repeal the excise tax on high cost employer-sponsored health coverage; Finance

H.R.394 (introduced by Rep. Lynn Jenkins): To amend the Internal Revenue Code of 1986 to repeal the amendments made by the Patient Protection and Affordable Care Act which disqualify expenses for over-the-counter drugs under health savings accounts and health flexible spending arrangements; Ways and Means

H.R.407 (introduced by Rep. Steve King): To amend the Internal Revenue Code of 1986 to allow a deduction for premiums for insurance which constitutes medical care; Ways and Means

H.R.408 (introduced by Rep. Steve King): To amend the Internal Revenue Code of 1986 to expand health savings accounts, and for other purposes; Ways and Means

H.R.409 (introduced by Rep. Steve King): To amend title XVIII of the Social Security Act to sunset certain penalties relating to meaningful electronic health records use by Medicare eligible professionals and hospitals, and for other purposes; Ways and Means, Energy and Commerce

H.R.410 (introduced by Rep. Steve King): To amend title XVIII of the Social Security Act to exclude coverage of advance care planning services under the Medicare program; Ways and Means, Energy and Commerce

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