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Category: On the Hill

Cures Passes House

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Last night, the House approved, 392-26, the 21st Century Cures Act, amended by a Manager’s Amendment submitted by House Energy and Commerce Chair Fred Upton (R-MI). While the Manager’s Amendment modifies slightly the allocation of funding in the NIH Innovation Account on an annual basis, it maintains the overall level of funding in the Account at a total of $4.796 billion between FYs 2017 and 2026. For the Precision Medicine Initiative, the Amendment provides $1.455 billion between FYs 2017 and 2026; for BRAIN, $1.511 billion between FYs 2017 and 2026; for cancer research, $1.8 billion between FYs 2017 and 2023; and for clinical research to advance regenerative medicine using adult stem cells, the Amendment provides $30 million between FYs 2017 and 2020.

The overwhelming vote tally gained more Republican votes and registered the same level of Democratic support when compared to the vote on a previous 2015 bill version (HR 6).

The legislation now moves to the Senate for consideration next week.

White House Supports Cures

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Late yesterday, the White House issued a Statement of Administrative Policy (SAP) in support of the 21st Century Cures legislation, which is on the House Floor today.

The SAP expressly calls out the Innovation Fund in the measure, which targets funding for several of the Administration’s health care priorities, as a highlight of the measure.

Read the SAP here. 

They’re BACK & 21st Century Cures to be Considered by the House

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Congress is back today for the remainder of its lame-duck session. While both the House and Senate are slated to be in session until December 16, Republicans appear content to run out the clock until President-elect Donald Trump is sworn in on January 20, which could make for a much shorter and less eventful lame duck session.

Congress still has a handful of legislative priorities to take care of before the end of this Congress, including passing a final National Defense Authorization Act and a government funding bill. The final fiscal 2017 defense policy bill could surface as early as this week. Once finalized, a conference report must be signed by House and Senate negotiators before final floor consideration in both chambers.

The compromise NDAA is expected to ditch contentious riders, including provisions on the greater sage grouse and workplace protections based on sexual orientation. It’s also expected to include $9 billion on top of the Pentagon’s budget request, incorporating the Administration’s $5.8 billion war supplemental request the Obama Administration submitted to Congress on November 10, as well as funding to cover military readiness shortfalls.

It’s still all about the money.  

Additionally, Congress needs to pass a spending bill to fund government by the December 9 to avoid a shutdown. Republican leaders decided before Thanksgiving to move a new continuing resolution (CR) through March, allowing Trump to put his mark on federal spending during his first year in office. Meanwhile, Appropriators and Congressional leadership continue to wrestle with an exact date in March to end the CR as well as if to include the supplemental funding requested by the Obama Administration. 

Agenda for the Week

In the House, lawmakers will consider a compromise bill seeking to spur efforts on medical innovation. A new version of the 21st Century Cures measure (HR 6) emerged on Friday after private negotiations among bill supporters and is headed toward a House vote on Wednesday of this week. House Members passed the original bill in 2015, but Senators were unable to complete the assembly their own bill.

The newly revised version tweaks funding, offsets and other provisions of the package seeking to revamp Food and Drug Administration procedures for approving new drugs and boosting biomedical research efforts of the National Institutes of Health.

The main order of business on the Senate floor is a bill that would study expanding a program to provide specialized medical treatments to rural and medically underserved communities.

Compromise on Cures Heads to House

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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. 

Trump First Day Agenda

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President-elect Trump posted a 2 minute 37 second video on You Tube, which is the first time he’s addressed the American people directly since the election.

Mr. Trump’s video included six calls for action on trade, immigration, energy, regulatory curbs, national security (specifically cyber infrastructure), and lobbying ethics changes, most of which have already been announced either during the campaign or the transition period.

Of note, Trump did not mention action on the Affordable Care Act, his proposed wall along the southern border, the tax code, or the Iran nuclear deal, all of which were central arguments for his election.

See the video here or below.