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No Additional Funding for NIH in CR

Senate Appropriations Labor-HHS subcommittee Chairman Roy Blunt (R-MO) has said today that the CR will not include the $2b bump to NIH that was included in the Senate bill. The CR, in whatever duration, should contain level funding of $32.084b or FY 2016 levels. There has been a research and health community effort to increase funding for NIH as an anomaly to the CR, but Blunt said today that it will not happen.

While this does not mean that an ultimate increase to NIH will not happen in a final FY 2017 package, it will not happen in the stopgap spending measure.

Additionally, there is now tension between the House and Senate as to when to end the CR. House is looking towards a March ending and the Senate wants a May date. 

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

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

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. 

Jindal HHS Secretary Possibility, Carson Out

Former Louisiana Governor Bobby Jindal is in the running for Secretary of HHS. He has health care policy in his background. At just 24 years old, he served as secretary of the Louisiana Department of Health and Hospitals, and later served as principal policy adviser to HHS Secretary Tommy Thompson in President George W. Bush’s administration. Pence and Jindal served in the House together. 

Jindal has proposed Obamacare replacement plan, which he first released in 2014. Full report: More. Executive summary: More.

However, others are still in the mix, and Jindal was no fan of Trump during the Republican primaries. Jindal also attempted a run for president this cycle and then threw his support to Rubio. That could take him out of serious contention. 

Dr. Ben Carson, presidential nominee, has announced he will not be in the Trump Cabinet effectively taking himself out of the running for a series of Secretary positions to which his name has been linked.

Lame Duck Priorities

Congress is scheduled to return next week for a Lame Duck session of Congress and many items still remain on the 2016 agenda before Trump takes office, including wrapping up the 11 remaining FY 2017 spending bills and a 21st Century Cures bill that both Majority Leader McConnell and Speaker Ryan said was a priority for passage in the Lame Duck session.  While President-elect Trump won’t be signing any bills in the lame duck, he will influence decisions on how to wrap up the 114th Congress.

While it is too soon to tell whether or not Congress will try to address its remaining legislative business in a Lame Duck session of Congress, or wait until President-elect Trump is sworn in on January 20 and Republicans control both the House and the Senate, a few things are fairly certain, dealing with the FY 2017 and the 21st Century Cures bill will be the Lame Duck priories.

FY 2017, Finishing the Fiscal Year

The current Continuing Resolution keeping the federal government open expires on December 9.  Prior to the elections, Republican leaders expressed support for passing a series of “minibuses” that would group appropriations bills together, while Democrats were leaning toward an omnibus bill that would include all of the remaining FY 2017 bills.  House Appropriations Committee Chair Rogers (R-KY) has said no decisions have been made yet on the process, but as of today, the House Appropriations Committee has put conference negotiations on hold pending further analysis.

However, Majority Leader Mitch McConnell said this week that funding the government remains a top priority heading into the lame duck and that lawmakers will wrap up spending bills this year rather than punt to the next Congress via another stopgap spending bill. McConnell said he plans to talk to House Speaker Paul Ryan and President Obama about how the FY 2017 bills could be enacted, but gave little in the way of specifics on how this would be accomplished.

That plan, though, was criticized by conservative House Freedom Caucus prior to the election as the Caucus continues to pushing for a continuing resolution to extend government funding into the next calendar year so that congressional Republicans can negotiate a spending package with Trump rather than Obama.

Must Pass? Should Pass? Legislation

Additionally, outstanding legislative priorities include the 21st Century Cures medical innovation package and mental health reform.  The Cures package is a particular priority of House Energy and Commerce Committee Chair Upton (R-MI), who is term limited as Chair. Upton has been vocal on having a package on the House floor next week when the House returned to session.  However, it’s unclear if the measure will be considered. Prior to the election, Democrats voiced wanting the mandatory funding for the National Institutes of Health in the bill, but also expressed desires to insert prescription drug controls and concerns about offsets. In addition, bringing a large mandatory spending bill to the floor may not help Ryan keep his speakership with his contentious caucus.

Several other issues remain before Congress, including the FY2017 National Defense Authorization Act (NDAA), which has seen some hiccups this year, but must pass annually. Also in limbo is the Water Resources and Development Act (WRDA), which passed the House and Senate respectively and is currently being conferenced.

Trade

The 12-nation Trans-Pacific Partnership agreement, which was a priority for The Obama Administration in the Lame Duck, will not be considered, according to House Ways and Means Chairman Kevin Brady (R-TX).  It will remain ”on hold” until President-elect Donald Trump decides whether to take action on the agreement in the next Congress.

SCOTUS

Supreme Court Justice Nominee Merrick Garland will not receive a confirmation hearing or a vote.  With the Senate remaining in Republican control, it will wait for President Trump to submit a new nominee for the Supreme Court after he is sworn in on January 20, 2017.

At this juncture, there are two likely scenarios for Congress to deal with these issues, and the outlook will be clearer in the coming days.

Clear the Decks

Under this scenario, President-elect Trump would indicate to Congress that he would like them to complete as much business as possible in the remaining days of the 114th Congress.  This would free up both President Trump, and the 115th Congress to focus on his priorities during the first 100 days of his Administration, as well as big-picture items such as a Supreme Court nomination and the debt-ceiling (which could be reached as early as March 2017).  This path would require some degree of cooperation from both the Obama Administration and the conservative element of the Republican conference.

Punting

The second scenario would be for Congress to push off all but must-do issues until after President-Elect Trump is sworn in.  Because Republicans would control both chambers of Congress and the White House, they would, in theory, have the ability to include more of their priorities in these bills before passage.  The risk in this scenario is that it bogs down the new Administration during their first days in office, at which time they will want to unveil new policy ideas, and when they have the most political capital to see those ideas to fruition.