The House Rules Committee has noticed that 21st Century Cures will be considered next week. The package is expected on the House floor on Wednesday, November 30. The legislation is expected to be added as an amendment to an existing bill (H.R. 34) to allow for expedited action in the Senate.
The House Rules Committee’s summary memo is 44 pages. The bill text is just under 1,000 pages. The package contains major provisions in the Cures and Senate Innovation packages, and the Mental Health Crisis Reform Act of 2016, (which includes Sections 9031 and 9032 on college mental health training and services grants and establishes interagency working group on mental health).
Generally
NIH is reauthorized until 2020 and the bill includes provisions intended to address the regulatory burden imposed on researchers, among other provisions. Rather than establish mandatory funding increases for NIH, appropriators would have to release (appropriate) funding each year to the Office of the Director. The bill establishes a similar mechanism providing $500 million for initiatives at FDA for FYs 2018-2026, and $1 billion for the Secretary to provide to states in FYs 2017 and 2018 for opioid abuse prevention and response efforts.
There are limitations to the general funds going to the office of the Director. The bill also establishes an “Innovation Projects” account for specific initiatives at NIH and FDA, which are special limitations on the general appropriations going to the Office of the Director. For NIH, the bill provides a total of $4.796 billion for FYs 2017-2026 to the NIH director, including $1.4 billion for the Precision Medicine Initiative, $1.564 billion for the BRAIN Initiative, $1.802 billion for cancer research, and $30 million for clinical research to further the field of regenerative medicine using adult stem cells.
The funding for the Innovation Fund is discretionary, but due to the phrasing in the legislation, monies the Innovation Fund does not count against the appropriators caps. However, the language essentially says that appropriations from the account are subtracted from the discretionary budget authority. What’s more important is that both CBO and the Administration (the OMB specifically) agree that spending from the Innovation funds do not count against the caps and the language works the way described below. The money will be put in a specific fund every year for the appropriators to use specifically for NIH, FDA, Cancer Moonshot, etc. In lay terms, the funds can only be used for these purposes and every dollar must be used in the next 10 years.
There are significant inclusions and some noticeable absences including:
- Section 2034 – Reducing Administrative Burden for Researchers (p 66). This section contains several provisions to reduce administrative burdens on grants, including subrecipients, financial conflict of interest reporting, and reducing burdens on animal care and use in research.
- Section 202 – Supports young, emerging scientists by prioritizing policies and programs (p. 45). FY 2017 appropriations includes funds for a national Academies of Science study on improving opportunities for new researcher; and Strengthens NIH’s existing loan repayment programs by increasing the yearly loan repayment amount from $35,000 to $50,000 and streamlining the loan repayment categories.
The revised draft also includes bipartisan, House-passed legislation, the Helping Hospitals Improve Patient Care Act of 2016 (H.R. 5273), that contains several provisions related to socioeconomic status (SES) adjustment and off-campus hospital outpatient department (HOPD) site-neutral payment policy.
To pay for this effort, the bill includes some of the offsets originally included in H.R. 6, including:
- Section 5009. Rescinds $3.5 billion for Prevention and Public Health Fund;
- Section 5010. Directs the DOE to sell a portion of the Strategic Petroleum Reserve;
- Section 5011. Rescinds $464 million available to U.S. territories under ACA.