5.21.18 – 5.25.18 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: both chambers will be on recess next week for the Memorial Day holiday. Unless activity warrants, we will send the next update on June 8.

BUDGET AND APPROPRIATIONS

FY19 Appropriations

This week both the House and Senate approved their 302(b) spending allocations for their fiscal 2019 bills. On Thursday, the Senate Appropriations Committee unanimously approved its allocations, 31-0. However, the Senate vote was in stark contrast to the House committee, where they approved their allocations along party lines, 29-22.

In the House, Democrats have fiercely opposed what they described as hyper-partisan allocations, accusing Republicans of favoring national security, instead of education or addiction programs. Besides the Defense bill, the biggest increases would go to the Military Construction-VA and Homeland Security bills. During the markup, Democrats argued that the border security boosts would come at a cost to the Labor HHS bill, which did not see a funding increase in fiscal 2019. Subcommittee Chairman Tom Cole (R-OK) defended his subcommittee allocation, arguing that critical health programs like the Centers for Disease Control and Prevention and the National Institutes of Health would still see an increase in FY19. Ranking Member DeLauro (D-CT) argued that such increases would come at the expense of other programs within the bill. Cole also said the figure is "likely to change" after conferencing with the Senate. The Senate’s plan would allocate $179.3 billion for the Labor HHS bill, about $2.2 billion higher than the House bill, which is frozen at current-year spending.

On Thursday, it was announced that the House will take up a "minibus" appropriations package in June after returning from the weeklong Memorial Day recess. The three measures included in the package will include, the Energy-Water, Military Construction-VA and Legislative Branch bills. The House Rules Committee posted the measure, with the Energy-Water bill as the vehicle, on its website Thursday and the panel announced that lawmakers who want to submit amendments need to do so by Wednesday, May 30, at 10 a.m., with a Rules Committee meeting on the package to be held sometime the week of June 4.

Senate Majority Leader Mitch McConnell said Thursday that he and Speaker Paul Ryan (R-WI) have been in discussions about the need to package some of the FY19 bills into minibuses to avoid an omnibus at the end of year. McConnell indicated he will begin moving spending bills to the Senate floor next month as well.

The Senate Appropriations panel has approved the FY19 Energy-Water and Agriculture measures, while their House counterparts have reported half of the 12 annual spending bills to the floor: Energy-Water, Agriculture, Military Construction-VA, Legislative Branch, Commerce-Justice-Science and Transportation-HUD. While it has not yet been announced, we understand that the House will consider their Labor HHS bill in subcommittee on June 12. The Senate Appropriations Committee has announced that they will take up the Labor HHS bill the week of June 25.

This week it was also reported that Senate Majority Leader Mitch McConnell could soon announce plans to cancel part of the four-week August recess to focus on passing FY19 spending bills and clearing nominees. No final decision has been made, and McConnell and Minority Leader Chuck Schumer (D-NY) have been discussing potential cooperation on nominees and spending bills, but many of the more junior senators reportedly like the idea of projecting a renewed work ethic as Senate control hangs in the balance this fall. As you might recall, McConnell partially canceled August recess last year, but this time around such a move has the side benefit of keeping the 10 vulnerable Senate Democratic incumbents in town during the summer while their Republican rivals campaign against them at home. Senator Dean Heller (R-NV) would also be affected by the move, but he has joined 16 senators calling on McConnell to cancel the recess and focus on spending bills and nominees.

Rescission Package

This week the House extended the deadline on the rescission package beyond the June 22 deadline as part of a rule for its National Defense Authorization Act. The House Rules Committee tucked language into the NDAA rule that essentially says that next week's recess days between May 25 and June 4 don't count as "calendar days" under the Budget and Impoundment Control Act. Given the extra 11 days, the new deadline for the Senate's filibuster-proof powers to expire would be roughly July 3.

In addition, the Government Accountability Office on Tuesday sent a report to congressional offices approving the vast majority of the administration's $15.3 billion plan to cancel spending, including the more than $7 billion in unused money from the Children's Health Insurance Program. Democrats have argued that the White House's attempt to target CHIP should disqualify it from the procedural advantage allowing the package to pass with just a simple majority.

The House has already drafted legislation mirroring the White House's request, which is expected to receive a House floor vote as early as the first week of June, however, at present they still lack the votes to pass such a package. Nearly a dozen House Republicans are now on the record voicing concerns with the bill, and many more remain noncommittal. Senate GOP leaders have not said whether they would take up an identical bill and several senators, including Lisa Murkowski (R-AK) and Susan Collins (R-ME), have raised issues with the package, including the cuts to CHIP. In the Senate, a single Republican "no" vote likely would be enough to sink the package. Democrats are expected to unanimously oppose the bill in both chambers.

The Trump administration is reportedly eyeing tweaks to their proposal in order to gain additional Republican votes. The White House is talking about canceling cutbacks for a wastewater treatment program at the EPA and might also scale back cuts included in the current package for Ebola funding and disaster relief. The White House, however, is unlikely to back down on its $7 billion cutback from the CHIP program, which could prove problematic for House Republican leaders.

OPIOIDS

While much of the public activity around legislative efforts to address the opioid misuse and overdose epidemic was on the Senate side this week, work behind the scenes continued on the House side as staff worked to prepare bills for floor consideration.

House leadership is planning to bring up bills to address the opioid misuse and overdose epidemic on the House floor the second week in June. Staff are working to determine offsets to pay for the legislation and decisions are being made about how the bills will move procedurally through the House. We understand the process for floor consideration will likely be similar to the process used for consideration of the Comprehensive Addiction and Recovery Act (CARA) in 2016 - each bill got a separate floor vote, largely under the expedited suspension process, and then the bills were bundled together by a rule and sent to the Senate as one large bill.

On the Senate side, as noted above, two Committees – Commerce and Judiciary – voted on legislation this week. As we have previously reported, the Senate will likely take up one package that combines the work of the various committees, including S. 2680, the Opioid Crisis Response Act, which was already approved by the Senate Health, Education, Labor and Pensions (HELP) Committee. It is unclear at this point whether the Senate will vote on the legislation this summer; while there is one view that Senate Majority Leader McConnell (R-KY) will not bring up the legislation because its passage might benefit vulnerable Senate democrats, others believe that the pressure on the Senate following House action may force a vote.

Senate Commerce

On Tuesday, the Senate Commerce Committee approved two bills related to the opioid misuse and overdose epidemic:

S. 2848, Fighting Opioid Abuse in Transportation Act (approved as amended by voice vote)
S. 2842, Opioid Addiction Recovery Fraud Prevention Act of 2018 (approved as amended by voice vote; Sen. Lee (R-UT) voted no)

Senate Judiciary Committee

On Thursday, the Senate Judiciary Committee approved the following bills:

S. 2645 Access to Increased Drug Disposal Act of 2018 (approved by voice vote; Sen. Lee voted no)

S. 2535 Opioid Quota Reform Act (approved as amended by voice vote)

S. 2789 Substance Abuse Prevention Act (approved as amended by voice vote; Sen. Lee voted no)

S. 207 Synthetic Abuse and Labeling of Toxic Substances Act of 2017 (approved by voice vote)

Senate Finance Committee

On Wednesday, the Senate Finance Committee announced the introduction of 22 bipartisan bills to address the opioid misuse and overdose epidemic (see attached list). The Committee is tentatively scheduled to hold a markup the first week in June after the Memorial Day break.

Senate Aging Committee

On Wednesday, the Senate Aging Committee held a hearing entitled, Preventing and Treating Opioid Misuse Among Older Americans. A summary of the hearing is attached.

House Education and Workforce

This week, the House Education and Workforce Committee announced the introduction of bills to address the epidemic. It is not anticipated that the Committee will markup the bills, but rather that they will be brought straight to the floor. These bills include:

H.R. 5889, Recognizing Early Childhood Trauma Related to Substance Abuse Act of 2018 | Dave Brat (R-VA) and Tom O’Halleran (D-AZ)
H.R. 5890, Assisting States' Implementation of Plans of Safe Care Act | Tom Garrett (R-VA) and Stephanie Murphy (D-FL)
H.R. 5891, Improving the Federal Response to Families Impacted by Substance Use Disorder Act | Glenn Grothman (R-WI) and Conor Lamb (D-PA)
H.R. 5892 | Jason Lewis (R-MN) and Matt Cartwright (D-PA)
House Oversight and Government Reform Committee

On Wednesday, the House Oversight and Government Reform Committee approved legislation (HR 5925) to reauthorize the Office of National Drug Control Policy (ONDCP). A press release, bill text and bill summary are available here.

PRESCRIPTION DRUGS

HELP Hearing on the Administration’s Drug Pricing Plan

On June 12, the Senate Health, Education, Labor and Pensions (HELP) Committee will hold a hearing titled, “The Cost of Prescription Drugs: Examining the President’s Blueprint ‘American Patients First’ to Lower Drug Prices.” Department of Health and Human Services (HHS) Secretary Azar will be the only witness.

Right to Try Legislation

On Tuesday, the House of Representatives passed S. 204, the so-called Right To Try Act, by a vote of 250-169. This bill allows terminally ill patients the “right to try” experimental drugs which have not been approved by the FDA for clinical use. Under the bill, a terminally ill patient who has exhausted approved treatment options may request from a drug company use of drugs in early development (Phase I or later). Supporters believe this will provide hope to families during difficult times, and will provide additional clinical data to help future drug development. Opponents contend the bill is unnecessary since the FDA has a similar process in place, and argue nothing in the bill would ensure patients can obtain the experimental drugs or afford them. The bill has previously been passed by the Senate, so the bill now goes to the President’s desk. As of the time of this report, the bill had yet to be signed.

Pandemic Preparedness

On Wednesday, the Senate HELP Committee passed the Pandemic and All Hazards Preparedness and Advancing Innovation Act by a vote of 22-1. The bill reauthorizes and reforms programs under HHS and other agencies which are involved in preparing for and responding to chemical, biological, radiological and nuclear threats. The bill:

Improves coordination between HHS and local hospitals and public health departments before and during pandemics;
Improves coordination between HHS and drug companies regarding the Strategic National Stockpile of medical countermeasures, focusing more on threat-based assessments;
Improves understanding of the critical supplies and healthcare workforce necessary for surge capacity;
Focuses HHS efforts on threats to which there is no countermeasure, antimicrobial resistance, and the universal flu vaccine.
Authorizes $385 million annually for the State and Regional Hospital Preparedness Program through 2023.

The programs expire at the end of September. It is unclear if this legislation will be packaged into a year-end catch-all bill, or if an extension of current law will be required. We will continue to monitor this matter.

MEDICARE & MEDICAID

On Tuesday, the House Ways and Means Committee Health Subcommittee held a third roundtable as part of the Committee’s “Medicare Red Tape Relief” initiative. The roundtable focused on post-acute care.

Chairman Brady (R-TX) noted that the Committee heard from over 100 post-acute care providers as part of their comment process and he emphasized the bipartisan nature of the process. Ranking Member Levin (D-MI) quipped, “There’s going to be tape, but it doesn’t have to red.”

Panelists included:

Long Term Care Hospitals (LTCHs)
Representative: Jim Prister, former President of National Association of Long Term Hospitals (NALTH), and President of RML Specialty Hospital
Guest: Paul Dongilli, President & CEO, Madonna Rehabilitation Hospitals
Inpatient Rehabilitation Facilities (IRFs)
Representative: Richard Kathrins, PhD, Chair, Board of Directors, American Medical Rehabilitation Providers Association (AMRPA)
Guest: Justin Hunter, Senior VP of Public Policy, Encompass Health
Skilled Nursing Facilities (SNFs)
Representative: Mark Parkinson, President & CEO, American Health Care Association
Guest: John Vrba, CEO, Burgess Square Healthcare & Rehabilitation Center
Home Health
Representative: Bill Dombi, President, National Association for Home Care and Hospice (NAHC)
Guest: Carol Gabig-Papst, MSN, RN, Director of Regulatory Compliance, University of Pittsburgh Medical Center (UPMC)
Hospice
Representative: Edo Banach, President & CEO, National Hospice and Palliative Care Organization (NHPCO)
Guest: Susan Lloyd, MSN, RN, President & CEO, Delaware Hospice
Guest: Robin Stawasz, LMSW, Director of Innovation, CareFirst of New York
Beneficiary Advocate Group
Representative: Megan O’Reilly, Director of Federal Health and Family Issues, AARP
Guest: Gwendolyn Miller, family caregiver, Washington, D.C.

Some of the key issues discussed by the panelists included:

The National Association of Long Term Hospitals (NALTH) raised maintaining the IMPACT Act’s timeline for implementing the unified post-acute care prospective payment system (PAC PPS)
Representatives on behalf of the inpatient rehabilitation facilities spoke about problems associated with the 60% rule and the need to add more conditions to the current list of 13 qualifying conditions
Representatives on behalf of the nursing home industry talked about increasing access to care provided by nurses and patient aids and consolidated billing
Home care industry representatives discussed allowing non-physicians providers to certify Medicare eligibility for home care services
The hospice and palliative care representatives raised modifying the requirement that a patient can only become eligible for hospice when they have a life expectancy of 6 months or less
The beneficiary panelist discussed a Centers for Medicare and Medicaid (CMS) pilot on a family caregiver model

A key theme discussed by both NALTH and AMPRA was improving transparency on post-acute data from CMS.

While a timeline for the introduction and consideration of legislation was not publicly discussion, Members and staff have indicated they would like to introduce a bill before the August break.

TRUMP ADMINISTRATION

HHS Family Planning Rule

On Tuesday, the Department of Health and Human Services published its notice for a proposed rulemaking which would change eligibility requirements for Title X family planning grants. Though the rule addresses many aspects of family planning, the biggest point of contention is related to grants to entities which perform abortions. As mentioned last week, the primary target of this rule is Planned Parenthood, which is the nation’s largest abortion provider. Though existing federal prohibits federal funds from abortion services, supporters of the rule contend there is not a firewall between abortions services and other family planning services. This rule addresses that matter by requiring a physical separation of facilities between those which perform abortions and those which provide other services. Another key aspect relates to abortion referrals and advice. Generally speaking, the rule would prohibit Title X dollars going to organizations which provide abortion referrals. It would, however, permit referrals in limited circumstances in which the patient has already chosen to end her pregnancy, in which case the doctor may refer the patient to other providers, so long as at least one is not an abortion provider. HHS is soliciting public comment regarding this rule, which will be due 60 days after it is posted on the Federal Register.

5-23-18 Senate Aging

5.23.18 Bipartisan Medicare, Medicaid & Human Services Bills to Address Opioid Epidemic-1

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