Health Policy Report

The Week in Review

In a busy week for the House, lawmakers approved a number of bills under suspension of the rules, including a measure altering regulations related to crowdfunding (H.R. 4855) and a long-awaited bill reforming mental health services (H.R. 2646). The mental health bill, which among other provisions would create an Assistant Secretary for Mental Health within the Health and Human Services Department, passed nearly unanimously on a 422-2 vote. In an additional bipartisan victory, House lawmakers approved the conference report (S. 524) to a measure intending to stem the opioid epidemic in another landslide vote, 407-5. Democrats had a late change of heart in supporting the measure, as many originally claimed that funding levels were insufficient. The bill now heads to the Senate, where it is expected to pass easily and be signed into law by President Obama before the summer recess.

The House also approved the Financial Services and General Government spending bill (H.R. 5485), albeit on a party line vote of 239-185. The spending measure includes cuts to the budgets of the Internal Revenue Service (IRS) and Securities Exchange Commission (SEC), and would also subject the Consumer Financial Protection Bureau (CFPB) to the annual appropriations process. In additional health policy action, the House approved a bill (H.R. 1270) 243-164 that repeals provisions in the tax code limiting the use of health savings accounts to only prescription drugs and insulin – essentially allowing those funds to be used for over-the-counter medication.

Meanwhile in the Senate, lawmakers approved legislation (S. 764) that would institute labeling requirements for genetically modified organisms (GMOs) in most groceries and supersede state regulations on the issue. The upper chamber then planned to move on to the fiscal 2017 defense appropriations bill, but that effort was blocked by Democrats due to concerns that Republicans would ignore other provisions in the budget deal struck last year. However, the $515.8 billion spending bill is expected to top the Senate agenda this week.

The Week Ahead

Congress has just five days left until their scheduled recess for the national conventions and the traditional August break, with a slate of significant time-sensitive legislation still awaiting action. Namely, the legislature’s to-do list includes airport security and Federal Aviation Administration (FAA) reauthorization, Iran sanctions, and a long-debated funding package to combat the Zika virus.   

Both chambers will be required to act on a bill reauthorizing the FAA ahead of the expiration of the aviation agency’s funding on July 15. The negotiated measure – which would extend the FAA’s authority through fiscal 2017 – lacks a controversial provision that would privatize air traffic control, bolsters airport security, and directs the FAA to take more action to prevent drones from flying near airports.

In the House, lawmakers are primed to take on one more appropriations bill before breaking for the summer. The fiscal 2017 Interior-Environment spending bill (H.R. 5538) would slightly cut funds for the Environmental Protection Agency (EPA) and gut some of the Obama Administration’s environmental regulations, while giving a funding increase to the Interior Department. House leaders have also lined up a trio of bills dealing with Iran and the 2015 agreement with world powers to curtail the country’s nuclear program. The measures would prevent the U.S. from buying heavy water from Iran (H.R. 5119), bar the White House from allowing Iran to access financial transactions involving the U.S. dollar (H.R. 4992), and hold Iran responsible for state sponsored terror and human rights violations (H.R. 5631).

On the Senate floor, lawmakers will debate a motion to proceed to the fiscal 2017 defense spending bill (H.R. 5293) after Democrats blocked the initial effort earlier this week. The Senate bill abides by the spending limits decided under last year’s budget deal and avoids dipping into the war funds account to pay for high-profile Pentagon weapons programs.

Finally, off the floor, both parties will be working to reach an agreement on Zika funding before the recess. Democrats have labeled the Republican-led effort as insufficient, while Republicans have insisted on the inclusion of offsets that would target other Democratic healthcare priorities.

House Labor-HHS Subcommittee Advances $161B FY '17 Spending Bill

The House Appropriations Labor, Health and Human Services (HHS), Education, and Related Agencies Subcommittee advanced a $161.6 billion fiscal year (FY) 2017 appropriations bill on a voice vote Thursday, despite objections from Democrats that it contains “poison pill” policy riders, does not provide enough money for priorities like Zika, and cuts programs for family planning and Centers for Medicare and Medicaid Services (CMS) operations. Democrats introduced a number of amendments during the markup which were all voted down. Among the amendments offered included provisions that would reverse the appropriation bill’s funding cuts to maintain current levels, restore $300 million in Title X family planning funds, designate $125 million to combat the spread of the Zika virus, eliminate all 15 policy riders attached to the bill, including one that defunds the Affordable Care Act (ACA), and allow the Centers for Disease Control (CDC) to conduct gun violence prevention research.

The spending bill, among other things, provides a $1.25 billion increase for the National Institutes of Health (NIH), which would bring the agency’s budget to $33.3 billion. The raise is short of the $2 billion increase approved by Senate appropriators last month. The bill also provides $7.8 billion for the CDC – roughly $605 million over current levels. The agency would receive $390 million to fight Zika and $300 million to create a new Infectious Diseases Rapid Response Reserve Fund that could be used for emergencies such as Ebola or Zika. Moreover, the bill provides funding to combat the opioid abuse crisis, including $581 million to the Substance Abuse and Mental Health Services Administration (SAMHSA) and $90 million for the CDC to address the epidemic.

Although the bill advanced out of Subcommittee and is expected to be marked up by full committee this week, it’s unlikely that it will ever make it to the President’s desk. While Republicans in the House could pass the bill, it would not meet the 60-vote threshold in the Senate, where the full Appropriations Committee has already approved its own bipartisan version of the bill. With time running out on the legislative schedule and focus shifting to the upcoming election, a continuing resolution is looking more and more likely.

House Approves Opioid Conference Report; Senate Dems Demur Over Funding Concerns

On Wednesday, members from both the House and Senate finalized the Opioid Conference Report aimed at addressing the country’s heroin and prescription drug abuse epidemic. Once considered largely bipartisan, the opioid legislation faces sharp criticism from Democrats whose amendments were rejected during the conference, including two that which would have provided $920 million in immediate funding to tackle opioid abuse over the next two years, fully offset.

What happens next remains to be seen, as conference committee Democrats say they will not vote for a bill that does not include funding. Although the House was able to quickly pass legislation Friday without Democratic votes, the report will likely stall in the Senate as Republican supporters do not have the 60 votes necessary to block a filibuster. The Obama Administration – which also wants additional funding – has yet to say whether it would veto opioid legislation that does not include funding. The Senate vote on the Conference Report is expected to take place this week.

Meanwhile, the White House unveiled a long list of new actions to combat the opioid abuse epidemic Thursday. As part of the announcement, the Administration finalized changes to restrictions on the number of patients per practitioner that may be prescribed buprenorphine-containing products to treat opioid dependence, raising the limit from 200 per practitioner to 275 patients per practitioner in the final rule. Furthermore, the White House announced that it is eliminating pain-management questions in the Hospital Consumer Assessment of Healthcare Providers and Systems survey from the hospital payment scoring calculation so that patient satisfaction in the treatment of pain is no longer viewed as an incentive for providers to prescribe pain relievers.

House Passes Mental Health Reform Bill

The House voted overwhelmingly Wednesday to pass bipartisan legislation aimed at reforming the nation’s mental health system. The Helping Families in Mental Health Crisis Act (H.R. 2646), which was introduced by Rep. Tim Murphy (R-PA) in the wake of the 2012 tragedy at the Sandy Hook Elementary School in Newtown, Connecticut, passed by a 422-2 vote.  Republicans opposed to new gun control measures have previously touted the legislation as their response to mass shootings. But less than two weeks after Democrats mounted a House sit-in over gun laws, Republicans and Democrats held to a tacit agreement to avoid the issue during floor speeches ahead of the vote on the bill.

The wide-ranging measure was originally intended as a massive overhaul of the mental health care system. But after disagreements over many controversial provisions, Energy and Commerce Committee Chairman Fred Upton (R-MI) introduced a pared-down version of the bill that stripped several costly and contentious provisions, including some that would have expanded access to psychiatric hospital beds and made it easier for doctors to share information about mentally ill patients. The budget-neutral bill authorizes new prevention and treatment programs, reauthorizes existing ones, restructures leadership at the Substance Abuse and Mental Health Services Administration (SAMHSA), and requires insurers to provide more robust coverage for eating disorders.

A companion measure that was approved unanimously out of the Senate HELP Committee earlier this year has also been subject to gun control politics. Chairman Lamar Alexander (R-TN) says he is hopeful the Senate will take up that measure in September.

Obama Administration Unveils New Steps in Precision Medicine Initiative

On Wednesday, the White House announced new steps towards its Precision Medicine Initiative, a research effort aimed at modernizing and accelerating biomedical discoveries, and bringing new treatments to patients faster. The Initiative – also known as the “Cancer Moonshot” – was launched after Vice President Joe Biden’s older son died of cancer last year.

The new steps include awarding $55 million in grants from the National Institutes of Health (NIH) to develop the initiative’s experimental cohort program where they plan to recruit millions of new participants to the program. The NIH plans to give this money to several health provider organizations, or HPOs, as well as a data research and support center and a participant technologies center. The HPOs chosen for grants include four regional medical centers, six community health centers and Veteran’s Administration health centers. They were selected with the goal of enrolling a diverse, representative set of participants into the cohort program. The data research and support center and the participant technologies center will aim to make the data gathered from the cohort secure and available to researchers and participants. The NIH is awarding grant money to Vanderbilt University, in collaboration with Verily and the Broad Institute, to create the data infrastructure of the cohort program. It’s also funding The Scripps Research Institute, Vibrent Health,  to develop methods of enrolling people directly into the study. In addition to Scripps and Vibrent, NIH has designated several sub-awardees which will share the $20 million award and work together on the Participant Technologies Center: Cambridge, Massachusetts-based online patient community platform PatientsLikeMe, Seattle-based Sage Bionetworks, which is best known for its work on Apple's ResearchKit, and Walgreens.

Meanwhile, the Food and Drug Administration announced draft guidance for a new oversight approach for genomic tests. Part of the Precision Medicine Initiative is facilitating innovation around genomic testing, in order to facilitate individualized treatment. Wednesday’s guidance aims to streamline oversight of DNA sequencing tests while maintaining safety standards. Developers would be able to opt into the new regulatory approach, which “aims to speed the development and scalability of genomic tests,” according to a White House fact sheet.