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.
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.
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:
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:
In a remarkable change of pace, the House and Senate came to a conference agreement on S.524, Comprehensive Addiction and Recovery Act this Wednesday. The agreement contains numerous provisions to combat increasing rates of opioid drug abuse, including through modifications to prescribing and pain management practices, by creating or modifying programs to expand access to treatment, particularly access to opioid overdose reversal drugs or medication-assisted treatment that eases withdrawal symptoms, and by establishing or strengthening specific programs for vulnerable groups such as drug-addicted infants. It also requires the Veterans Affairs Department (VA) to take several actions to better manage and track the use of opioids by veterans.
In both chambers and in the conference committee process, Democrats sought to add hundreds of millions of dollars in appropriations to ensure that individuals suffering from opioid addiction would have access to treatment; however, those efforts were blocked. Because of the lack of funding, the Administration has expressed opposition to the agreement — but has not issued a formal veto threat.
Today, the House almost unanimously approved legislation, by a vote of 407-5, to combat opioid overdoses after Democrats dropped their opposition to the bill at the last minute. The vote all but assures that the bill will sail through the Senate and head to President Obama’s desk next week. The legislation, a top priority for GOP leaders, is expected to be one of Congress’s biggest achievements this year.
Early Thursday morning, the House approved a Zika funding package, the product of a House-Senate conference report that was crafted just hours before.
House Democrats’ unusual daylong protest over gun control finally ended early Thursday morning after Republican leaders moved to adjourn the House through the July 4 recess – without a gun vote.
As a result, House hearings and legislation that had been planned for this week are now delayed at least 11 days. Another consequence, and shocking bonus — a surprisingly speedy vote on a major Zika funding deal.
What’s in the $1.1 billion package:
The package is offset by about $750 million from unspent Ebola and Obamacare funds, in addition to another $100 million from HHS’s administrative fund. It now heads to the Senate for a vote, where it’s expected to face resistance.
Democrats on the House Appropriations Committee said they won’t support the deal and called for negotiations to continue.
After the measure passed, the House recessed for the Fourth of July work period.