12.10.18 – 12.14.18 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.
FY19 Appropriations
On Tuesday, Senate Minority Leader Chuck Schumer (D-NY) and House Minority Leader Nancy Pelosi (D-CA) met with President Trump to discuss his proposed border wall and a way forward on Fiscal Year 2019 Appropriations. During the meeting, which was conducted in front of the press despite numerous attempts by Pelosi to take the negotiations behind closed doors, Trump said he would be proud to shut down the government if he doesn’t get money for a border wall.
Schumer said after the meeting that he and Pelosi made two offers to avoid a shutdown. In one case, they could pass six of the seven remaining appropriations bills, plus a year-long continuing resolution for the Homeland Security spending bill. In the other, they could rely on a year-long stopgap for all seven bills. Without a continuing resolution or a spending deal for the remaining seven FY19 bills, there will be a partial government shutdown on December 22.
With no deal in sight, incoming House Appropriations Committee Chairwoman, Nita Lowey (D-NY) on Wednesday introduced a CR for all seven remaining spending bills. Lawmakers this week have also discussed the possibility of a full-year CR for the Homeland Security bill while passing the other six FY19 bills. On Thursday, Senate Appropriations Committee Chairman Richard Shelby (R-AL) said Republicans are discussing options for a short-term stopgap to avoid a partial shutdown. The short-term stopgaps being considered will extend government operations for varying amounts of time and include possible dates of December 26, January 3, sometime in February, or sometime in May. There are also discussions about advancing a continuing resolution that would run through the end of fiscal year 2019.
Earmarks
On Tuesday, House Democratic Leader Steny Hoyer (D-MD) at a reporter briefing predicted Congress will bring back earmarks early next year. He said they are a key part of Congress' constitutional authority to tell the executive branch exactly where federal money should go. This sentiment is shared by the senior Democrats on the House Appropriations Committee including the incoming chair, Rep. Nita Lowey.
Hoyer also listed the specific reforms Congress put into place before the practice ended when Republicans regained control of the House in 2010 as potential guidelines for future earmarks. He said only not-for-profit or public-sector entities would be eligible to receive earmarks, and that the lawmaker who puts in the request has to put his name on the request and also affirm that neither he or she or any family member will benefit financially.
Hoyer also indicated that the Republican Senate leadership is open to the change. House Republicans have privately indicated support for bringing back earmarks but are waiting to see what Democrats decide when they take control of the House in the 116th Congress. There was an attempt to restart the earmark process in early 2017 which was stopped by Speaker Paul Ryan (R-WI).
Republican Sen. Roy Blunt (R-MO), who chairs the Senate Labor HHS Appropriations Subcommittee, has said that its ultimately up to the House to revise its position since that's where the formal prohibition against earmarks was put in place. He also said there's "great interest" in the Senate in bringing earmarks back. Senate Majority Leader Mitch McConnell (R-KY) has thus far been non-committal.
HEALTH POLICY LEGISLATION
Health policy bills on spending package
As of press time, it still remains unclear how much, if any, health and/or tax policy legislation may hitch a ride on the CR and/or appropriations bill referenced above.
Work continues to resolve issues with two bills – the Over-the-Counter Drug Safety, Innovation and Reform Act (S. 2315) and the Pandemic and All-Hazards Preparedness Act (S. 2852). Staff indicated to us this week that they were hopeful the holds placed on the bills could be resolved to allow the legislation to be attached to whatever form the spending package takes.
While we reported last week that there were last minute negotiations to reach an agreement on modifications to 42 CFR Part 2 addiction treatment privacy protections, staff have since indicated to us that they think it is unlikely a deal is reachable this year.
This week, House Ways and Means Committee Chairman Brady (R-TX) introduced a modified version of his tax package. Unlike the previous iteration, this version does address some of the Affordable Care Act’s taxes including delaying the medical device tax. However, it is unclear if there is enough support for the package for it to be taken up and passed this year. If tax extenders are not addressed before the end of the year, incoming Ways and Means Committee Chairman Neal (D-MA) said they would look at taking them up quickly in 2019.
Fetal Tissue Research
On Thursday, two House Oversight Committee subcommittees — Healthcare, Benefits, and Administrative Rules as well as Government Operations – held a hearing on Fetal Tissue Alternatives. The hearing largely focused on the issue of abortion with the discussion falling along party lines, with Republicans expressing concerns about the source of fetal tissue and decrying federal funding for Planned Parenthood and Democrats lamenting the "wasteful" replay of abortion investigations. Democrats also praised the merits of fetal tissue research in significantly advancing the development of vaccines and new therapies. Witness statements and a webcast can be found here.
The hearing follows the NIH announcement that it will pause acquisitions of fetal tissue while it conducts an agency-wide review of all financial contracts involving fetal tissue. On December 10, NIH announced that it would spend $20 million to find alternatives to using fetal tissue.
Following the hearing, Rep. Diana DeGette (D-CO), the incoming head of the Energy and Commerce Oversight Subcommittee, said her panel plans to scrutinize the Trump administration’s handling of fetal tissue research in the next Congress.
Energy and Commerce 21st Century Cures Hearing
On Tuesday, the Energy and Commerce Subcommittee on Health held a hearing reviewing the implementation of the Interoperability title of the 21st Century Cures Act. The only witness was Donald Rucker, M.D., National Coordinator for Health Information Technology. He noted that while progress has been made, additional work is necessary to help advance the availability of electronic health information to patients and their providers. He said that barriers to the appropriate and secure movement of electronic health information include technical limitations and business incentives, but the Cures Act takes a great step toward addressing those barriers. He summarized by saying that ONC has made great progress toward implementing key provisions of the 21st Century Cures Act and that these actions will maximize the potential of health IT and result in improved care and reduced cost. He also noted that due to development timelines and the size and complexity of the U.S. health system, it is important to note that nationwide interoperability will take time to achieve.
Drug Pricing Rebate Legislation
The House approved legislation this week intended to punish drug manufacturers that attempt to game the Medicaid drug rebate system. The provision was approved as part of a Medicaid bill (HR 7217), which also included the Advancing Care for Exceptional (ACE) Kids Act, The Ensuring Medicaid Provides Opportunities for Widespread Equity, Resources (EMPOWER) and Care Act and The Protecting Married Seniors from Impoverishment Act.
Ways and Means Bills
On Tuesday, Republican members of the House Ways and Means Committee introduced several bills as part of the Committee’s Reducing Medicare Red Tape initiative and targeting rural health issues. According to a release from the Committee, the legislation includes:
- H.R. 7248, the Reducing Administrative Burden and Becoming Increasingly Transparent Act, introduced by Rep. Kenny Marchant (R-TX). This bill gives Medicare providers a vehicle for submitting comments to CMS every year on how to reduce administrative burden in each Medicare payment system. It also gives post-acute care providers a new platform to weigh in on the development of a unified post-acute care payment system, while ensuring that all post-acute care providers are afforded the opportunity to directly engage with CMS.
- H.R. 7253, the Remove Extraneous Measures that Obstruct Value and Efficiency (REMOVE) Act, introduced by Rep. Jason Smith (R-MO). This bill codifies all measure removal factors for hospital and post-acute care quality measures, including the newest measure removal factor #8 that weighs the benefits of a measure against the costs of reporting the measure. Additionally, the bill codifies principles for meaningful measures that the Secretary should take into account when selecting quality measures within the Medicare program, including that measures are meaningful to patients and providers, address high-impact measure areas that safeguard public health, are outcome-based where possible, and minimize the level of burden for providers.
- H.R. 7247, the Incentivizing Shared Risk in Medicare Advantage, introduced by Chairman Brady and Energy and Commerce Member Rep. John Shimkus (R-IL). This bill clarifies that a Medicare Advantage organization may establish a waiver process to exempt physicians that engage in financial risk arrangements with the plan. Additionally it expresses support for these types of private sector driven arrangements.
- H.R. 7249, the Better Prior Authorization Notification Act, introduced by Rep. Tom Reed (R-NY). This bill requires notification to providers and beneficiaries that will be impacted by prior authorization.
- H.R. 7250, the Prior Authorization Improvement Act, introduced by Rep. Mike Kelly (R-PA) and Energy and Commerce Member Rep. Brett Guthrie (R-KY). This bill requires a study on the feasibility of existing technologies that can help streamline and reduce the burden of prior authorization requests in MA.
- H.R. 741, the Rural Hospital Regulatory Relief Act of 2017, introduced by Rep. Lynn Jenkins (R-KS). This bill permanently extends the application by CMS of an instruction against the enforcement of certain physician supervision requirements with respect to outpatient therapeutic services in critical access hospitals and small rural hospitals.
- H.R. 5507, the Critical Access Hospital Relief Act, introduced by Rep. Adrian Smith (R-NE). This bill repeals the 96-hour physician-certification requirement for inpatient critical access hospital services under Medicare. Under current law, as a condition for Medicare payment for such services, a physician must certify that a patient may reasonably be expected to be discharged or transferred to a hospital within 96 hours after admission to the critical access hospital.
Reducing Health Care Costs
On Tuesday, Senate Health, Education, Labor and Pensions (HELP) Committee Chair Alexander (R-TN) released the attached letter soliciting comments on how the federal government can reduce health care costs. We understand part of the Committee’s focus next year will also be on looking at reducing regulatory burden. Comments are due March 1, 2019.
116TH CONGRESS
Senate Schedule
The Senate’s 2019 calendar was released this week and is attached. It largely mirrors the previously released House schedule.
House Leadership Term Limits
On Wednesday, House Democratic Leader Nancy Pelosi struck a deal with a group of Democrats intent on denying her the speakership, all but ensuring she will have the votes to become speaker in the 116th Congress. The agreement would limit her time as speaker to no more than four additional years. The proposal also limits to three terms the time her two deputies, Minority Whip Steny Hoyer (D-MD) and Assistant Democratic Leader Jim Clyburn (D-SC), can stay in their posts, although those changes will likely have to be ratified by the full caucus. The leaders have an option to pursue a fourth term but must win two-thirds support of the caucus to do so. Currently only a majority is required. The term limits are also retroactive, meaning the four years Pelosi served as speaker beginning in 2007 would count against her, and the same goes for Hoyer and Clyburn, meaning the longest the three of them can serve in their current posts is through 2022, though they could serve in other leadership positions. The House will hold a vote to elect the Speaker on January 3.
House Committee Chairmen
House Democratic Leader Nancy Pelosi (D-CA) on Tuesday revealed a list of Steering and Policy Committee recommendations for House chairmen in the next Congress. Most of the leadership assignments go to the ranking members in the current Congress, except Rep. Mark Takano (D-CA) at Veterans’ Affairs. A full list of chairmen can be found below.
- Appropriations: Nita Lowey (D-NY)
- Energy and Commerce: Frank Pallone (D-NJ)
- Ways and Means: Richard Neal (D-MA)
- Agriculture: Collin Peterson (D-MN)
- Armed Services: Adam Smith (D-WA)
- Education & Labor: Bobby Scott (D-VA)
- Financial Services: Maxine Waters (D-CA)
- Foreign Affairs: Eliot Engel (D-NY)
- Homeland Security: Bennie Thompson (D-MS)
- Judiciary: Jerrold Nadler (D-NY)
- Natural Resources: Raul Grijalva (D-AZ)
- Oversight & Government Reform: Elijah Cummings (D-MD)
- Science, Space & Technology: Eddie Bernice Johnson (D-TX)
- Small Business: Nydia Velázquez (D-NY)
- Transportation & Infrastructure: Peter DeFazio (D-OR)
- Veterans’ Affairs: Mark Takano (D-CA)
Senate Ranking Members
In the Senate, Minority Leader Chuck Schumer (D-NY) on Tuesday announced the chamber’s ranking members.
- Agriculture: Senator Debbie Stabenow (D-MI)
- Appropriations: Senator Patrick Leahy (D-VT)
- Armed Services: Senator Jack Reed (D-RI)
- Banking: Senator Sherrod Brown (D-OH)
- Budget: Senator Bernie Sanders (I-VT)
- Commerce: Senator Maria Cantwell (D-WA)
- Energy: Senator Joe Manchin (D-WV)
- EPW: Senator Tom Carper (D-DE)
- Finance: Senator Ron Wyden (D-OR)
- Foreign Relations: Senator Bob Menendez (D-NJ)
- HELP: Senator Patty Murray (D-WA)
- HSGAC: Senator Gary Peters (D-MI)
- Judiciary: Senator Dianne Feinstein (D-CA)
- Rules: Senator Amy Klobuchar (D-MN)
- Small Business: Senator Ben Cardin (D-MD)
- Veterans’ Affairs: Senator Jon Tester (D-MT)
- Aging: Senator Bob Casey (D-PA)
- Ethics: Senator Christopher Coons (D-DE)
- Indian Affairs: Senator Tom Udall (D-NM)
- Intelligence: Senator Mark Warner (D-VA)
- Joint Economic Committee: Senator Martin Heinrich (D-NM)
Senate Democratic Committee Rosters
Yesterday, Senate Democrats announced Committee rosters for next year. Sens. Hassan (D-NH) and Cortez Masto (D-NV) will become members of the Senate Finance Committee in the next Congress.
Additionally, Sen-elect Rosen (D-NV) will join the HELP Committee. Membership lists for key Committees with healthcare jurisdiction are below and a complete list is attached.
Appropriations
Senator Leahy – Vice Chairman
- Senator Murray (D-WA)
- Senator Feinstein (D-CA)
- Senator Durbin (D-IL)
- Senator Reed (D-RI)
- Senator Tester (D-MT)
- Senator Udall (D-NM)
- Senator Shaheen (D-NH)
- Senator Merkley (D-OR)
- Senator Coons (D-DE)
- Senator Schatz (D-HI)
- Senator Baldwin (D-WI)
- Senator Murphy (D-CT)
- Senator Manchin (D-WV)
- Senator Van Hollen (D-MD)
Finance
Senator Wyden – Ranking Member
- Senator Stabenow (D-MI)
- Senator Cantwell (D-WA)
- Senator Menendez (D-NJ)
- Senator Carper (D-DE)
- Senator Cardin (D-MD)
- Senator Brown (D-OH)
- Senator Bennet (D-CO)
- Senator Casey (D-PA)
- Senator Warner (D-VA)
- Senator Whitehouse (D-RI)
- Senator Hassan (D-NH)
- Senator Cortez Masto (D-NV)
Health, Education, Labor & Pensions
Senator Murray – Ranking Member
- Senator Sanders (I-VT)
- Senator Casey (D-PA)
- Senator Baldwin (D-WI)
- Senator Murphy (D-CT)
- Senator Warren (D-MA)
- Senator Kaine (D-VA)
- Senator Hassan (D-NH)
- Senator Smith (D-MN)
- Senator Jones (D-AL)
- Senator Rosen (D-NV)
Aging
Senator Casey – Ranking Member
- Senator Gillibrand (D-NY)
- Senator Blumenthal (D-CT)
- Senator Warren (D-MA)
- Senator Cortez Masto (D-NV)
- Senator Jones (D-AL)
- Senator Sinema (D-AZ)
- Senator Rosen (D-NV)
TRUMP ADMINISTRATION
HIPAA RFI
On Wednesday, the HHS Office of Civil Right issued a Request for Information (RFI) on HIPAA privacy laws. The RFI poses 54 questions on topics ranging from patient access to health information to sharing with social service agencies to expanding data clearinghouses' access to patient health data. Comments are due on February 12, 2019.
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