Leadership Declares Cures a Priority for Lame Duck

In a series of separate announcements last week, House and Senate leadership have declared that the passage of the 21st Century Cures Act is a priority for both chambers when lawmakers return in November. Senate Majority Leader Mitch McConnell (R-Ky.) highlighted funding the government and the 21st Century Cures bill as his own personal priorities, noting that the latter “could end up being the most significant piece of legislation we pass in the whole Congress.” In his weekly press briefing, Speaker of the House Paul Ryan (R-Wis.) said that his focus would be on sending 21st Century Cures and mental health reform legislation to the President’s desk. Leadership of the House Energy and Commerce Committee also released a statement reiterating their commitment to getting the medical innovation bill signed into law this year. The bipartisan statement was signed by Chairman Fred Upton (R-Mich.), Rep. Diana DeGette (D-Colo.), Ranking Member Frank Pallone (D-N.J.), Health Subcommittee Chairman Joseph Pitts (R-Pa.) and Ranking Member Gene Green (D-Texas). A revised version of the legislation is expected to be released immediately following the election recess. The new version of the bill could be in part offset by a proposal that would allow for pharmaceutical manufacturers to obtain samples needed to create generic versions of brand-name drug treatments. The offset would be a rewrite of the CREATES Act (S. 3056), introduced by Sen. Patrick Leahy (D-Vt.), which could produce $2.9 billion in savings over the next decade.

Members Urge CMMI to Stop Mandatory Experiments

Members of the House of Representatives have written to the Centers for Medicare and Medicaid Services (CMS) Acting Administrator Andy Slavitt and Deputy Administrator Patrick Conway urging the agency to limit the size and scope of demonstrations administered by the Centers for Medicare and Medicaid Innovation (CMMI). The letter was led by House Budget Committee Chairman Tom Price, M.D. (R-Ga.), Ways and Means Committee Member Charles Boustany Jr., M.D. (R-La.), and Ways and Means Member Erik Paulsen (R-Minn.) and was signed by 176 other House members. The lawmakers ask CMS to commit to seeking Congressional approval if expansion of demonstrations require changes to the underlying statute. They also urge the agency to establish an open and transparent process that supports communication with stakeholders in the development of new models. The letter specifically points to the Part B Drug Payment Model, the Comprehensive Care Joint Replacement (CJR) Model, and the Cardiac Bundle Payment Model as examples of CMMI’s overstep of authority.

Recently Introduced Health Legislation

H.R.6174 (introduced by Rep. Peter Welch): To amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title; Energy and Commerce; September 27

H.R.6184 (introduced by Rep. Robert J. Dold): To amend title XVIII of the Social Security Act to provide for a special enrollment period under Medicare for individuals enrolled in COBRA continuation coverage, and for other purposes; Energy and Commerce, Ways and Means, Education and the Workforce; September 27

H.R.6185 (introduced by Rep. Yvette D. Clarke): To provide for further comprehensive research at the National Institute of Neurological Disorders and Stroke on unruptured intracranial aneurysms; Energy and Commerce; September 27

H.R.6215 (introduced by Rep. Marc A. Veasey): To amend the Internal Revenue Code of 1986 to exempt from the individual health insurance mandate certain low-income individuals residing in States that have not elected the Medicaid expansion under the Patient Protection and Affordable Care Act; Ways and Means; September 28

H.R.6224 (introduced by Rep. Joyce Beatty): To amend the Public Health Service Act to promote the inclusion of minorities and women in clinical research, and for other purposes; Energy and Commerce; September 28

H.R.6226 (introduced by Rep. Tom Price): To delay the Medicare demonstration for pre-claim review of home health services, and for other purposes; Energy and Commerce; September 28

H.R.6241 (introduced by Rep. Ron DeSantis): To amend the Federal Food, Drug, and Cosmetic Act to provide for reciprocal marketing approval of certain drugs, biological products, and devices that are authorized to be lawfully marketed abroad, and for other purposes; Energy and Commerce, Rules; September 28

H.R.6243 (introduced by Rep. Daniel M. Donovan, Jr.): To improve the ability of the Federal Government to address synthetic opioids, and for other purposes; Energy and Commerce, Judiciary, Oversight and Government Reform; September 28

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