8.20.18 – 8.24.18 Health Wrap Up
Please find below a summary of the latest major health policy developments in Washington this week. Please let us know if you have any questions.
Scheduling note: The House remains on recess through Labor Day.
BUDGET AND APPROPRIATIONS
FY19 Appropriations
Yesterday, the Senate voted, 85-7, to approve a combined FY19 Labor HHS and Defense spending bill. Prior to the vote on final passage, the Senate adopted by unanimous consent a manager’s package that includes 53 of the 309 filed amendments to the package (see attached for text of all 53 amendments accepted as part of the managers). Senators earlier in the week approved four additional non-controversial amendments.
Among the amendments agreed to as part of the managers package, those of interest include:
- An amendment from Senators Blunt (R-MO), Murray (D-WA), and Alexander (R-TN) transferring $5 million from the National Institute of Health (NIH) Office of the Director to the HHS Office of the Inspector General “for oversight of grant programs and operations of the NIH, including agency efforts to ensure the integrity of its grant application evaluation and selection processes”;
- An amendment from Senators Cassidy (R-LA) and King (I-ME) to require NIH to conduct a comprehensive study of current funding levels related to mental health and substance use disorders;
- An amendment from Senators Peters (D-MI) and Capito (R-WV) requiring a report not later than 180 days after the date of enactment of the Act from the Administrator of the Substance Abuse and Mental Health Services Administration (SAMHSA) on agency activities related to medication-assisted treatment. Specifically, the report “shall include a description of how the agency is taking steps to overcome barriers to medication-assisted treatment for adolescents and young adults.”
- An amendment from Senators Donnelly (D-IN) and Crapo (R-ID) that added $1 million to CDC’s Environmental Health Center for a cancer cluster study, paid for with a $1 million cut to CDC’s National Institute on Occupational Health and Safety.
- An amendment from Senators Casey (D-PA) and Young (R-IN) to provide $10 million to carry out Title I of the Child Abuse Prevention and Treatment Act (CAPTA) in response to the most recent Catholic church scandal.
Earlier in the day, Senator Grassley (R-IA) threatened to delay final passage of the spending package if a measure he proposed with Senator Durbin (D-IL) that would set aside $1 million to implement regulations requiring drug companies to disclose their prices in television ads was not included. Ultimately, a provision was added to the manager’s amendment.
In addition, disagreements over votes for amendments proposed by Senator Rand Paul (R-KY) and Joe Manchin (D-WV) threatened to derail the process. Ultimately, Paul’s amendment, which would have barred federal funding for Planned Parenthood, received a vote, but did not clear the 60 vote threshold required for adoption. The Manchin amendment, which would have expressed a sense of the Senate that the chamber's legal counsel be authorized to represent the Senate in a lawsuit filed by the state of Texas seeking to invalidate the 2010 health law, particularly its protections for pre-existing conditions, did not end up receiving a vote in the end.
With passage of the Defense and Labor HHS bills, the Senate has now cleared 9 of the 12 fiscal 2019 spending bills. The House to date has cleared 6 of their FY19 spending bills. The House and Senate are now expected to enter into conference negotiations to reconcile their Defense and Labor HHS bills with the intention of getting these bills to the President by the end of the fiscal year. This will be a tall order given that lawmakers only have about five weeks to hash out differences in competing versions of the measures given that the House is in recess until after Labor Day and there are only 11 workdays before the September 30 deadline.
As you know, President Trump said he would not sign an omnibus spending bill again this year, so Congressional leaders are working under a plan to send spending bills to his desk in smaller batches. Any bills not signed into law before September 30 will likely be funded under a continuing resolution through the election and into a lame-duck session of Congress.
Senate HELP NIH Hearing
On Thursday, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing entitled, Prioritizing Cures: Science and Stewardship at the National Institutes of Health. A webcast of the hearing and opening statements can be found here.
Issues that came up during the short hearing include: support for young scientists; the ability to recruit and retain scientists; things NIH is doing to help with the opioid epidemic; status of regenerative medicine research following passage of the 21st Century Cures bill; affordable and accessible therapies/drugs; and the All of Us Research Program.
Of particular interest were comments and questions from Senator Hassan (D-NH). She noted that she was proud to help secure additional funds for New Hampshire through SAMHSA State Opioid Response Grants. She thinks it is important to stay focused on the hardest hit states and ensure they get the concentration of grants they need. She also noted the importance of supporting science to find ways to treat addiction and manage pain and she appreciates the work NIH is doing on the HEAL Initiative to advance this science. In a previous appearance, Dr. Collins said he needed more flexibility from Congress to allow the NIH to fund research on the opioid epidemic more quickly and efficiently. Hassan touted the ACE Research Act, which would give NIH the flexibility it needs to quickly advance research on new treatments and non-addictive pain medications by providing other transaction authority. She wanted to know how other transaction authority provided by the ACE Research Act will help NIH’s work on the opioid epidemic, including through the HEAL Initiative.
Dr. Collins noted the importance of other transaction authority and why the timing is urgent. One project the NIH is excited about includes identifying maybe three areas in the US hit hard by the epidemic where they can bring together all players/support systems to see what they can do if everyone works together in a coordinated way to tackle the problem. This has never really been done before and having flexibility through other transaction authority will allow this to happen faster and more effectively. NIH is going to do this anyway but having other transaction authority in next month would make a big difference in NIH’s ability to carry out that part of the HEAL Initiative. Senator Hassan responded that she hopes Congress can pass this legislation, along with a more comprehensive opioid package soon.
OPIOIDS LEGISLATION
Negotiations continued in the Senate this week in an effort to reach an agreement on a legislative package to address the opioid misuse and overdose epidemic. At a press conference on Tuesday, Leader McConnell (R-KY) said that opioids legislation is a “priority for the post Labor Day weekend” and that Senate HELP Committee Chairman Alexander (R-TN) is leading the effort to develop a package based on the work of the four Committees of jurisdiction (HELP, Finance, Judiciary and Commerce) in the hopes that the bill can be considered on the floor under a time agreement or possibly by voice vote.
While the situation is fluid, staff indicated to us that they currently expect the Senate to pass a package in September and a House/Senate conference of some kind (it does not appear to have been decided whether there will be a formal conference or not) would likely follow in October. Under this scenario, with the House scheduled to be on recess for most of October and the Senate also possibly on recess for at least part of the month leading up to the November elections, final passage would likely wait until the lame duck session.
AFFORDABLE CARE ACT
GAO Reports
This week, the Government Accountability Office (GAO) released two reports regarding different aspects of the implementation of the Affordable Care Act (ACA).
One report, authored by the Office of the Comptroller General within GAO, examined the high-risk areas affecting Medicaid. GAO found that Medicaid faces three areas of greatest risk:
- Improper Payments: GAO recommends the Centers for Medicare and Medicaid Services (CMS) improve program integrity of managed care organizations (MCOs), including additional auditing, to ensure MCOs are billing properly. GAO also recommends CMS and states work to improve data collection via the T-MSIS system to better identify improper payments.
- Supplemental Payments: GAO will review CMS’s soon-to-be-released rule to provide more complete data to ensure supplemental payments are made only for Medicaid-covered services.
- Medicaid Demonstrations: GAO found demonstrations are an increasingly large portion of CMS’s budget, and it is concerned it is becoming more difficult to assess the demonstrations’ cost neutrality and if they achieving their intended results. GAO recommends CMS and the Department of Health and Human Services (HHS) establish written procedures for improved evaluation of the Medicaid demonstrations’ effectiveness.
GAO testified on the report at a hearing at the Senate Homeland Security Committee this week. The report may result in CMS placing greater scrutiny and administrative costs on hospitals and providers participating in MCOs and demonstration projects. As of yet, it is unclear how that accountability will play out and to what extent that could inhibit the provision of care.
The other GAO report released this week dealt with HHS’ efforts regarding the ACA’s individual market exchanges. GAO found reduced enrollment could threaten the long-term viability of a government-supported individual market system. GAO found a number of factors have led to the reduction in individual market enrollees in recent years. Key findings in GAO’s report include:
- The biggest factor for reduced participation in the individual market is the high cost of plans
- Reduced participation leads to a downward spiral of increased premiums
- Reduced regulation of navigator price information led to a difficult customer experience
- HHS reduced public promotion of healthcare.gov open enrollment period by 90%
Given the Trump Administration’s skepticism of the ACA generally, it is unclear if they will make efforts to adopt any of GAO’s recommendations to address the shrinking marketplace enrollment.
Maine Medicaid Expansion
In another ACA fight that seems to continue long after expected finality, on Thursday the Maine Supreme Judicial Court ruled that Governor Paul LePage must begin implementing the voter-approved expansion of Maine’s Medicaid program. In 2017, nearly 60% of Maine voters approved Medicaid expansion. The expansion would add roughly 70,000 people to the state’s Medicaid program. However, Governor LePage has fought the referendum with every tool available to him. In the latest round, he refused to budget any funds for state officials to develop plans for the expansion. LePage recently vetoed a spending bill providing administrative costs, and an effort to override that veto failed. Thursday’s ruling stated that Maine must submit a preliminary plan on the expansion. Although a spokesperson for LePage stated the governor is reviewing the decision, the spokesperson noted that the court’s decision did not address underlying state constitutional issues which require an appropriation of funds to conduct the work necessary to expand the program. LePage has previously stated he is prepared to go to jail to block the bill, so the Thursday ruling may not be the end to this fight.
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