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Learn about policy issues important to medical schools and teaching hospitals, with Executive Vice President Atul Grover, M.D., Ph.D.
House Overwhelmingly Approves 21st Century Cures Package
December 2, 2016—The House of Representatives Nov. 30 approved, by a vote of 392-26, the 21st Century Cures Act (H.R. 34), which includes new funding for the National Institutes of Health (NIH) and Food and Drug Administration (FDA), as well as mental health provisions and other hospital and health care provisions.
AAMC President and CEO Darrell Kirch, MD, sent a letter of support to House leaders and released a statement following the passage of the bill, urging the “Senate to pass this critical legislation.” Dr. Kirch also noted that the “bill recognizes the importance of more funding for the National Institutes of Health (NIH), reducing the administrative burden for medical researchers, and the role of socioeconomic status—SES—in the Medicare hospital readmissions reduction program,” adding that the new funding for NIH is meant to “supplement—not supplant—increases to the base NIH budget.”
The bill establishes an “Innovation Account” for specific initiatives at the NIH and the FDA. The bill provides $500 million for initiatives at the FDA. For NIH, the bill provides $4.796 billion, including:
$1.455 billion for the Precision Medicine Initiative;
$1.511 billion for the Brain Research through Advancing Innovative Neuroethologies (BRAIN) Initiative;
$1.8 billion for the Cancer Moonshot Initiative; and
- $30 million for clinical research to advance regenerative medicine using adult stem cells.
In addition to the new funding for NIH and FDA, the bill includes provisions to address health disparities, data collection, and young researchers. This bill also would implement many of the recommendations of the National Academies of Sciences, Engineering, and Medicine report Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century: Part 1, which would reduce the administrative burden on researchers.
The bill also incorporates socioeconomic status (SES) into the Medicare Hospital Readmissions Reduction Program (HRRP). Further, the bill exempts off-campus teaching hospital outpatient departments (HOPDs) that either attested that the regulatory requirements were met prior to Dec. 2, 2015, or were “mid-build” upon passage of the Bipartisan Budget Act of 2015 (P.L. 114-74) from so-called “site-neutral” payment policies. It also provides $1 billion for states to support opioid abuse prevention and response efforts.
House Energy and Commerce Committee Chairman Fred Upton (R-Mich.) and Ranking Member Diana DeGette (D-Colo.) noted that “21st Century Cures is the innovation game-changer that patients, their loved ones, and the nation’s researchers and scientists so desperately need.” Speaker of the House Paul Ryan (R-Wis.) added, “With this bill, we are laying the groundwork for medical breakthroughs that will help countless Americans suffering from what today are considered incurable diseases.” The White House Nov. 29 issued a Statement of Administration Policy, noting that the administration “strongly supports” the package.
The AAMC-led Ad Hoc Group for Medical Research Nov. 29 issued a statement, noting that the bill “provides a meaningful injection of funds for lifesaving biomedical research.”
The Senate is expected to consider and approve the bill early next week.
House Approves Title VIII Reauthorization Bill
Rep. Lois Capps (D-Calif), who introduced the legislation, praised the House for passing the bill, noting, “For half a century, Title VIII Nursing Workforce programs have made important gains in recruiting the best nursing students, getting them trained, and keeping them in the field.” Capps added, “This bipartisan reauthorization effort will ensure that nurses continue to meet our nation’s health care system needs now and in the future.”
Key provisions of the reauthorization bill include: reauthorizing through fiscal year (FY) 2020 Title VIII nursing workforce programs, which provide loan repayment and incentives to work in underserved communities; and revising the advanced education nursing education grant program to include clinical nurse leaders as advanced education nurses.
Sens. Jeff Merkley (D-Ore.) and Richard Burr (R-N.C.) July 7 introduced a Senate companion, S.3245, but it has not yet been taken up by the Senate Health, Education, Labor, and Pensions (HELP) committee.
Preliminary Injunction Issued on Department of Labor Overtime Rule
December 2, 2016—A U.S. District Court in Texas Nov. 22 issued a nationwide preliminary injunction that blocks the Department of Labor's (DOL) overtime rule from going into effect on Dec. 1. Under a key provision of the rule, full-time salaried individuals paid an annual salary less than $47,476 would have been eligible for overtime as “non-exempt” employees [see Washington Highlights, May 20]. The Justice Department Dec. 1 filed a notice that it intends to appeal the injunction.
The National Institutes of Health (NIH) Aug. 10 announced that it plans to increase postdoctoral National Research Service Award (NRSA) stipends to levels at or above the $47,476 threshold. The NIH Nov. 7 reiterated that it “plans to raise its NRSA stipends for consistency with [the] spirit of the DOL’s support for increased pay, as reflected in its recent revisions to the overtime regulations.” NIH Deputy Director Mike Lauer, MD, Nov. 23 reaffirmed the guidance.
Although prompted by the DOL rulemaking, NIH’s authority to increase stipends for NRSA postdocs is not dependent on the rulemaking taking effect. The AAMC continues to support NIH’s recommended stipend levels for post-docs.
Jodi B. (Lubetsky) Yellin, PhD
Director, Science Policy
Matthew Shick, JD
Director, Gov't Relations & Regulatory Counsel
On The Hill
December 2, 2016—President-elect Donald Trump Nov. 29 nominated Rep. Tom Price, MD, (R-Ga.) to be Secretary of the Health and Human Services Department. Additionally, Seema Verma was nominated to be administrator of the Centers for Medicare and Medicaid Services.
House Minority Leader Nancy Pelosi (D-Calif.) was re-elected another term to lead the House Democrats after defeating Rep. Tim Ryan (D-Ohio) by a vote of 134 to 63.
Rep. Greg Walden (R-Ore.) was elected as the next chairman of the House Energy and Commerce Committee while Rep. Phil Roe, MD, (R-Tenn.) was elected to serve as the next chair of the House Veterans Affairs Committee. Rep. Sander Levin (D-Mich.) announced that he will not seek reelection for the ranking member position on the House Ways and Means Committee.
On The Agenda
Dec. 6: Health IT Policy and Standards Joint Committee Meeting
9:30 a.m.; Webinar
The Office of the National Coordinator (ONC) for Health Information Technology (HIT) Standards Committee and Policy Committee will meet via webinar to discuss standards implementation specifications and certification criteria for the electronic exchange of health information.
Dec. 8-9: NIH Advisory Committee to the Director Meeting
9 a.m.; NIH Campus, Bethesda, Md.
The National Institutes of Health Advisory Committee to the Director (ACD) will hold a meeting. An agenda for the meeting is posted to the website. Meeting topics include: the ACD Diversity working group report; ACD HeLa working group report; and the Environmental influences on Child Health Outcomes Program.
Dec. 8-9: MedPAC Meeting
Time: TBD; 1300 Pennsylvania Ave., N.W., Washington, D.C.
The Medicare Payment Advisory Commission (MedPAC) will meet to discuss Medicare issues and policy questions and to develop and approve reports and recommendations to the Congress
Dec. 8: HRSA Advisory Committee on Interdisciplinary, Community-Based Linkages Meeting
10 a.m.; Webinar
The Advisory Committee on Interdisciplinary, Community-Based Linkages will meet via webinar to discuss policy and program development and other matters of significance related to activities under Part D, Title VII of the PHS Act, as amended by the Affordable Care Act.
Washington Highlights, a weekly electronic newsletter, features brief updates on the latest legislative and regulatory activities affecting medical schools and teaching hospitals.
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Sr. Program & Policy Specialist, Govt Relations
Senior Legislative Analyst