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News and updates

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. 

What We’re Reading This Week, November 21 – 25

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Here’s a selection of articles the Federal Relations team is enjoying this week.

Medicaid Worries – In places like rural Kentucky, the ACA was a life changing law for Medicaid patients. Eliminating the expansion will have serious impacts. Read more at NPR.  

Trump & TV – Representatives from the broadcast and cable-TV news networks met with President-elect Donald Trump Monday. The unprecedented gathering follows Trump’s public disdain for most of the media which was evident throughout the election. Beyond what he often considered unfair coverage, the pre-election polling and Election Day exit polls appeared to predict a Hillary Clinton win. It did not go well according to inside sources. Read more in the New York Post. 

Whither OSTP? – For 40 years, the Office of Science and Technology Policy (OSTP) has closely counseled the President on matters of science and technology—everything from disease outbreaks to climate change to nanotechnology. However, the role of OSTP in the Trump administration is unclear. Read more in The Atlantic. 

Autism & Higher Ed – The first generation of students with an autism diagnosis is fanning out to schools across the country. They face a complex array of academic and social challenges. Read more in The New York Times. 

DeVos to be ED Secretary

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President-elect Donald Trump is nominating Betsy DeVos for Education Secretary. A billionaire GOP donor, she also once served as head of the Michigan Republican Party.

DeVos is a vocal advocate of allowing parents to use school vouchers to seek alternative schools and other policies strongly opposed by teachers unions. She is the current chairwoman of the American Federation for Children, an education advocacy group pushing school-choice-friendly policies.

 

 

Trump Taps SC Gov. Nikki Haley for UN

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South Carolina Governor Nikki Haley has accepted Donald Trump’s offer to be his ambassador to the United Nations. She is the first woman Trump has tapped to his cabinet, and would add diversity as a woman and the daughter of immigrants from India. A rising star in the GOP, she is the first woman to hold the Governor’s office in South Carolina. Haley served three terms in South Carolina’s State House before winning the governorship in 2010 and again in 2014. Haley’s limited foreign policy experience is likely to draw scrutiny during Senate confirmation hearings for the Cabinet-level position.