THE DAILY WHIP: FRIDAY, JULY 10, 2015

Complete Consideration of H.R. 6 – 21st Century Cures Act (Rep. Upton – Energy and Commerce).  This bill provides $8.75 billion in mandatory funding for the National Institutes of Health (NIH) over the next five years, which is meant to spur scientific innovation and discovery by providing an additional, supplementary funding stream to NIH.   

This bipartisan measure modifies current federal processes involving medical research, developing drugs and other treatments, and testing and approving those drugs and treatments in an effort to accelerate the development and delivery of cures to diseases and medical conditions. 

The bill directs funds towards high-risk, high-reward research performed by early stage investigators. NIH is encouraged to use the new influx of dollars to address areas of unmet medical needs, including but not limited to, biomarkers, precision medicine, infectious diseases, and antibiotics. The measure would promote the maintenance of the best biomedical workforce in the world, including increasing the diversity of the biomedical workforce. Additionally, H.R. 6 modifies the regulatory framework for medical devices and the oversight of certain technology by the Food and Drug Administration (FDA). The bill also would ensure system-wide accountability for the interoperability of electronic health record systems‎ to enhance communication and information sharing in the delivery of patient care. Additionally, the bill includes a provision that applies any policy riders included in the annual Agriculture and Labor-HHS appropriations bills, including language related to the Hyde Amendment to NIH and FDA funds in H.R. 6.

The cost of this measure is fully offset through the sale of oil from the Strategic Petroleum Reserve, limiting federal Medicaid reimbursements to states for durable medical equipment to Medicare rates, and other reforms to Medicare and Medicaid ‎drug reimbursements. CBO estimates the measure will save over $500 million in the next decade.  Members are urged to VOTE YES.

As of last night, the House had completed all general debate.  Today, the House will consider amendments to H.R. 6. 

The Rule, which was adopted yesterday, provides for no further general debate and makes in order 8 amendments, each debatable for 10 minutes, equally divided between the offeror and an opponent.  The amendments are:

Brat/McClintock/Garrett/Stutzman/Perry Amendment.  Reforms the NIH and Cures Innovation Fund to make it a discretionary spending program.
Young (IN)/Harris Amendment.  Creates authority within NIH to conduct a prize program. The intent of the program would be to incentivize health innovation by offering competitors the chance to win a prize for creating breakthrough research and technology.
Lee/Schakowsky/Clarke Amendment.  Strikes the provision that applies any policy riders included in the annual LHHS Appropriations Bill, including language related to the Hyde Amendment to NIH funds in H.R. 6 . Also strikes the provision that applies any policy riders applied to the FDA in the annual Agriculture Appropriations bill to FDA funding in H.R. 6.
Castro Amendment.  Ensures underrepresented individuals, such as women and minorities, are included in the Supporting Young Emerging Scientists Report.
Slaughter Amendment.  Directs the CDC to conduct a study to determine how the additional payments are affecting the development of drug resistance.
Fitzpatrick Amendment.  Expresses a sense of Congress that recording Unique Device Identifiers at the point-of-care in electronic health record systems could significantly enhance the availability of medical device data for post-market surveillance purposes.
Polis Amendment.  Directs the Food and Drug Administration to issue a report on the risks and benefits associated with a two-tiered approval process that would permit certain medical devices to provisionally come to market if they have demonstrated safety but not efficacy.
Jackson-Lee Amendment.  Directs the Secretary of Health and Human Services to conduct outreach to Historically Black Colleges and Universities; Hispanic Serving Institutions; Native American Colleges; and rural Colleges to ensure that health professionals from underrepresented populations are aware of research opportunities under this Act.

Bill Text for H.R. 6:
PDF Version

Background for H.R. 6:
House Report (HTML Version)
House Report (PDF Version)