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.
BUDGET AND APPROPRIATIONS
FY19 Appropriations
On Monday, the Senate Appropriations Committee announced that they plan to hold 12 individual bill markups in a six-week stretch, completing consideration of all FY19 bills by June 29. The Labor HHS bill will be considered the week of June 25. Senate Appropriations Committee Chairman Richard Shelby (R-AL) said this week that the Senate could skip part of its August recess to bring some of the FY19 bills to the floor, in an attempt to avoid an omnibus in September. The House Appropriations Committee has not indicated when they will consider their Labor HHS bill, but to date the full committee has considered five bills and two additional bills have been considered in subcommittee. The full Senate markup schedule is below:
- Week of May 21-25: Energy-Water and Agriculture-FDA
- Week of June 4-8: Transportation-HUD and Military Construction-VA
- Week of June 11-15: Interior-Environment, Commerce-Justice-Science and Legislative Branch
- Week of June 18-22: State-Foreign Operations, Homeland Security and Financial Services.
- Week of June 25-29: Defense and Labor-HHS-Education
Senate NIH Hearing
On Thursday, the Senate Labor HHS Appropriations Subcommittee held a hearing to review the FY19 budget request for the National Institutes of Health. Topics of interest included funding for opioids, Alzheimer’s disease, cancer and big data. A summary of the hearing is attached.
Witnesses included:
- Dr. Francis S. Collins, M.D., Ph.D., Director, National Institutes of Health
- Dr. Norman Sharpless, M.D., Director, National Cancer Institute
- Dr. Walter Koroshetz, M.D., Director, National Institute of Neurological Disorders and Stroke
- Dr. Anthony Fauci, M.D., Director, National Institute of Allergy and Infectious Diseases
- Dr. Richard Hodes, M.D., Director, National Institute on Aging
- Dr. Nora Volkow, M.D., Director, National Institute on Drug Abuse
Paul Budget
On Thursday, the Senate failed to advance toward a vote on a budget-cutting proposal from Senator Rand Paul (R-KY). Senator Paul said he wanted to force a floor vote on his budget cutting plan to single out dozens of his fellow Senate Republicans who have signed off on a “massive spending binge” this year, including those who voted for the FY18 omnibus and the recent budget deal. The motion to proceed to the bill failed 21-76. Because Senate leadership is not rolling out its own fiscal 2019 budget plan this year, any senator is allowed to present his or her own proposal for a floor vote.
OPIOIDS
This week the House Ways and Means and Energy and Commerce Committees held markups of bills to address the opioid misuse and overdose epidemic. As we have previously reported, House leaders are preparing to bring bills to the floor in June and the first week after Memorial Day is rumored to be “opioids week.”
On the Senate side, as of press time, two Committees - Commerce and Judiciary - have noticed markups for next week. We understand the Senate Finance Committee is also readying bills for markup. As you know Senate Health, Education, Labor and Pensions (HELP) Committee Chair Alexander (R-TN) said he has asked Leader McConnell (R-KY) for floor time this summer so that the bill reported by HELP may be considered with legislation approved by the other committees.
House Ways and Means
On Wednesday, the House Ways and Means Committee held a markup of bills to address the opioid misuse and overdose epidemic. A summary of the markup is attached.
House Energy and Commerce
On Thursday, the House Energy and Commerce Committee held the second half of their markup of legislation. While the markup was largely collegial, it ended on a very partisan note as Democrats were upset that the majority did not call up a bill sponsored by Rep. Tonko (HR 3962) related to buprenorphine prescribing. Chairman Walden (R-OR) said they did not bring up the bill because the Committee had received feedback from stakeholders and the Drug Enforcement Administration asking them to hold off on expanding prescribing authority until more data is available. A detailed summary of the markup is attached.
Senate Commerce
On Tuesday, the Senate Commerce Committee will hold a markup. Bills that have been noticed that relate to opioids include:
- S. 2848, Fighting Opioid Abuse in Transportation Act, Sponsor: Sen. John Thune (R-S.D.)
- S. 2842, Opioid Addiction Recovery Fraud Prevention Act of 2018, Sponsors: Sens. Shelley Moore Capito (R-W.V.), Catherine Cortez Masto (D-Nev.)
Senate Judiciary Committee
The Senate Judiciary Committee noticed for May 17, but then held over until next week (as is the Committee’s normal custom), bills to address the opioid misuse and overdose epidemic. Bills that have been noticed for the May 24 markup include:
- S. 2645 Access to Increased Drug Disposal Act of 2018 (Ernst, Blumenthal, Grassley)
- S. 2535 Opioid Quota Reform Act (Durbin, Kennedy, Feinstein, Grassley)
- S. 2789 Substance Abuse Prevention Act (Cornyn, Feinstein, Tillis, Klobuchar)
- S. 207 Synthetic Abuse and Labeling of Toxic Substances Act of 2017 (Klobuchar, Graham, Feinstein, Grassley, Whitehouse, Hatch, Blumenthal, Cornyn, Tillis, Kennedy)
- S. 2838 Using Data to Prevent Opioid Diversion Act of 2018 (Feinstein, Grassley, Durbin)
- S. 2837 Preventing Drug Diversion Act of 2018 (Hassan)
340B DRUG PRICING PROGRAM
On Tuesday, the Senate Health, Education, Labor and Pensions (HELP) Committee held an oversight hearing over the 340B program. As the first hearing following President Trump’s new prescription drug price plan, many were eager to see the reaction of Committee members. Though Chairman Alexander described it as a sweeping plan to put patients and taxpayers first, no other Republicans commented. Democrats, however, were very critical, stating that the rhetoric of reducing prices does not match official actions, such as withdrawing a HRSA proposed rule to verify drug company pricing. At the hearing, there was consensus that the 340B program requires greater transparency on drug ceiling prices and hospital charity services, as well as a better-defined mission. Members of both parties mentioned the importance of 340B to keeping some hospitals open. Some Democrats highlighted the “uneven playing field” of regulation whereby hospitals are more heavily scrutinized under the program than drug companies. A summary of the hearing is attached.
TRUMP ADMINISTRATION
Title X Funding Restrictions
On Friday, the White House announced the Department of Health and Human Services will no longer allow Title X family planning dollars to go to recipients which perform abortions. There are conflicting media report whether the rule would also apply to recipients that provide information about abortion services, such as referrals or other clinical information. The intended target of this proposed rule is Planned Parenthood. That group argues abortion is a legal medical service, and the new rule would jeopardize millions of STD tests, free birth control, and cancer screenings. But groups like Susan B. Anthony List argue the rule does not cut funding, but directs it to organizations which do not advocate abortions. The rule is under review at the Office of Management and Budget, which reviews all proposed rules, and it is unclear when the matter will formally be announced by HHS. Once the rule is noticed, it is almost certain the matter will be litigated in federal court.
Prescription Drug Blueprint Reaction
Following last week’s prescription drug speech, HHS Secretary Alex Azar gave additional remarks, giving additional understanding of what the Trump Administration plans with the prescription drug blueprint. In his remarks, Azar described in greater detail some of the elements of the Blueprint.
- Banning pharmacy benefit managers from negotiating rebates with drug companies.
- Move more expensive drugs from Medicare Part B to Part D where insurers have more negotiating power.
- Improve CMS’s drug dashboard to provide better transparency of drug pricing.
- Expose brand-name drug companies which do not share data with companies planning to develop a generic version.
The health care industry has had a chance to let the dust settle and examine the real impact of the plan. Compared to then-candidate Trump, who had a much more aggressive posture regarding drug companies, the Blueprint is a relief to drug makers. Some of the boldest steps which could have been taken were not. As a result, publicly traded drug companies saw their stocks rise this week.
New VA Secretary Nominee
On Friday, President Trump nominated Robert Wilkie to be the next Secretary of Veterans’ Affairs. Wilkie is currently the Under Secretary of Defense for Personnel and Readiness, as well as Acting Secretary of VA.
May 17 Senate NIH hearing summary 5-17-18 EC 5-16-18 WM 5-15-18 HELP May 17 Senate NIH hearing summary
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