Trump Nominates Former Eli Lilly President for HHS Secretary

President Trump has announced his plans to nominate former Eli Lilly & Co. president Alex Azar to be the next Secretary of the U.S. Department of Health and Human Services (HHS). Former Secretary Tom Price, MD resigned from the Cabinet position in late September following reports of taxpayer-funded private jet travel. Azar’s ties to the pharmaceutical industry are expected to be scrutinized by Senate Democrats. While the Senate Finance Committee has jurisdiction to vote on the nomination and advance it for consideration by the full Senate, the nominee will also appear at a hearing before the Senate Health, Education, Labor, and Pensions (HELP) Committee next week. Azar will likely be questioned about his stance on the implementation of the Affordable Care Act (ACA), as well as the issue of rising drug costs. Azar has spoken on the subject several times in the past, remarking that other parts of the supply chain such as insurers and drug plans also bear responsibility for the increasing cost of prescription medications. Azar previously served as general counsel (2001-2005) and deputy secretary (2005-2007) of HHS during the Bush administration. He then served for a decade at Eli Lilly as senior vice president of corporate affairs and communications leading the company’s U.S. operations. He is also the chairman and founder of Seraphim Strategies, LLC, a strategic consulting firm focused on the biopharmaceutical and health insurance industries.

Gene Green to Retire in 2018

Rep. Gene Green (D-Texas) will not seek reelection when his current term expires. After having served for more than two decades in the House, Green expressed his wish to spend more time with his family. Green currently serves as the Ranking Member of the House Energy and Commerce Health Subcommittee.

Hospitals File Lawsuit to Block 340B Cuts

Three hospital groups have filed a lawsuit against the Administration to block steep cuts to the 340B drug discount program. The American Hospital Association, Association of American Medical Colleges, and America’s Essential Hospitals argue that the Centers for Medicare and Medicaid Services’ (CMS) plan to cut payments for physicianadministered drugs by more than 28 percent beginning January 1 threatens patient access to care for uninsured and other vulnerable populations. Lawmakers have introduced bipartisan legislation in the House of Representatives to prevent the cuts from going into effect. The bill (H.R. 4392) was introduced by Reps. David B. McKinley (R-W.Va.) and Mike Thompson (D-Calif.) last week.

FDA to Develop LDT Certification Process Pilot Program

The Food and Drug Administration (FDA) plans to launch a program in the coming months to certify laboratories that develop diagnostic tests, instead of writing regulations for the tests themselves. The laboratory-developed test (LDT) precertification process will be modeled after the agency’s pilot approval program for manufacturers of digital health products. The LDT plan will not overlap with the rules of the Clinical Laboratory Improvement Amendments (CLIA) administered by the Centers for Medicare and Medicaid Services (CMS). If the pilot program is successful, the FDA plans to seek legislation to codify it into law.

Upcoming Congressional Hearings and Meetings

The House Committee on Oversight and Government Reform field hearing on Combating the Opioid Crisis; 12:30 p.m., Chevy Chase Auditorium – 1st Floor, Johns Hopkins Hospital, 1800 Orleans Street Baltimore, MD 21287; November 28

Senate Health, Education, Labor, and Pensions Committee hearing on the Nomination of Alex Azar to serve as Secretary of Health and Human Services; 9:30 a.m., 430 Dirksen Bldg.; November 29

Senate Health, Education, Labor, and Pensions Committee hearing “The Front Lines of the Opioid Crisis: Perspectives from States, Communities, and Providers;” 10:00 a.m., 430 Dirksen Bldg.; November 30

Senate Judiciary Committee hearing to examine firearm accessory regulation and enforcing Federal and state reporting to the National Instant Criminal Background Check System (NICS); 10:00 a.m., 226 Dirksen Bldg.; December 6

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