Health Policy Report

The Week in Review

The farm bill was the main action for the House last week, which came to an end with a surprising failed vote on Friday. The nutrition and agriculture package (H.R. 2) became embroiled in the immigration debate as the House Freedom Caucus decided to oppose the farm bill unless a vote was held on a conservative immigration measure first. Seeing the bill as one of the last major opportunities to flex their muscle before this fall’s midterms, the conservative caucus led the charge against the bill — with all Democrats also voting against due to its inclusion of work requirements for the Supplemental Nutrition Assistance Program (SNAP) — ultimately resulting in its failure Friday on a 198-213 vote. The failure comes as a major embarrassment for House Republican leadership, and will likely further incite the calls for votes on immigration proposals of both the conservative and moderate variety in the coming weeks.

News coming from the Senate last week centered on two votes: one on a resolution to overturn the Federal Communications Commission’s repeal of Obama-era net neutrality rules, and another to confirm Gina Haspel as Director of the Central Intelligence Agency (CIA). The net neutrality resolution (S.J. Res. 52) — which was opposed by most Republicans — was forced to the floor due to procedural rules under the Congressional Review Act and passed 52-47 with Sens. Susan Collins (R-ME), Lisa Murkowski (R-AK) and John Kennedy (R-LA) joining the minority. The resolution now heads to the House, where it is unlikely to overcome the stronger Republican majority. Haspel was confirmed Thursday as the first female director of the CIA, overcoming Democratic opposition over her role in the CIA’s interrogation program that had been known to use methods now considered torture.

The White House announced that it would nominate Acting Veterans’ Affairs Secretary Robert Wilkie to head the Department on a permanent basis after their original pick, White House physician Ronny Jackson, was forced to withdraw earlier this month. Wilkie, who's also undersecretary for defense and readiness at the Pentagon, has served as acting secretary since President Trump fired David Shulkin in March.

The Week Ahead

The Senate-passed financial regulatory relief bill will be back in the spotlight this week with just a few days left in the work period before the Memorial Day recess. The House is aiming to take up the bill (S. 2155), which broadly intends to ease the regulatory regime imposed on small and medium-sized banks by the 2010 Dodd-Frank financial reform law, among other changes. The measure is expected to pass in the House thanks to the Republican majority and a likely cadre of Democratic moderates, which will send the bill to a supportive President Trump to be signed into law. Other anticipated action in the House includes consideration of ‘right to try’ legislation (S. 204) that would allow terminal patients to use unapproved medical products and the annual National Defense Authorization Act (NDAA).  

The Senate has a mix of confirmations and legislation on its docket for the week. Among the nominees to be confirmed are Dana Baiocco to be a Commissioner of the Consumer Product Safety Commission, Jelena McWilliams to be Chair of the Federal Deposit Insurance Corporation (FDIC), and James Evans to be Ambassador to Luxembourg. Senators are also likely to consider a bill (S. 2372) that includes funding for the Veterans’ Affairs Choice program that funds private care for veterans. The bill passed the House last week on a 347-70 vote.

The primary season also continues this week with elections scheduled in Arkansas, Georgia, Kentucky, and Texas tomorrow. Texas’ voters will be voting in a runoff for the gubernatorial nomination, while Georgia’s gubernatorial primary features five Republican candidates and two Democrats seeking to succeed Gov. Nathan Deal.

HHS Promotes Drug Pricing Plan in Week-Long Blitz

Top officials from the Department of Health and Human Services (HHS) made waves last week as the administration sought to promote their recent announcement of a comprehensive blueprint to reduce prescription drug prices. The initiative, entitled ‘American Patients First,’ includes policies to address four key areas: (1) better negotiation; (2) increasing competition; (3) lowering out-of-pocket costs; and (4) lowering list prices.  The administration also released an official request for information (RFI) last week on the plan, kicking off a highly-anticipated 60-day public comment period that is sure to see feedback from patients and stakeholders from across the pharmaceutical supply chain.

Last Monday, HHS Secretary Alex Azar kicked of the week by delivering a landmark address on the initiative, as he offered targeted rebukes of pharmaceutical manufactures who have increased prices and claimed that “the entire system of pharmacy benefit managers negotiating rebates needs to be re-examined.” Secretary Azar made clear during his speech that the administration plans to use the bully pulpit to publicly admonish bad actors, suggesting that President Trump himself “is going to be very interested in the next company that takes a price increase not justified by inflation or change in clinical benefit.” The Secretary also addressed criticisms that the plan does not go far enough by proposing direct government negotiation or importation of prescription drugs, pointing to analysis from the Congressional Budget Office (CBO) which concludes that neither idea would generate significant savings.

Secretary Azar’s top deputies also hit the ground running last week, as the Centers for Medicare and Medicaid Services (CMS) released updates to their drug spending dashboard, and the Food and Drug Administration (FDA) publicized a list of branded drug companies that have allegedly obstructed development of generic drugs (see below for details).

House to Vote This Week on Senate-Passed ‘Right to Try’ Bill

The House is set to vote this week on Senate-passed legislation aimed at making it easier for sick patients to access experimental drugs — a top priority for the White House, spurred by the long-time support of Vice President Mike Pence. In August, the Senate passed ‘right to try’ legislation by unanimous consent, but the House took up their own version of the measure after Energy and Commerce Committee Chairman Greg Walden (R-OR) expressed concerns with the Senate bill. But as House Democrats have voiced concerns about patient safety — a sentiment reinforced by various patient advocacy groups — Senate Democrats followed suit, and the path forward in the upper chamber has become increasingly tenuous. As Senate Minority Leader Charles Schumer (D-NY) has recently objected to a request to bring the House bill up by unanimous consent, ‘right to try’ advocates have since seen a House vote on the Senate-passed version as their best path forward. The House has already passed a separate version of ‘right to try’ legislation on a 267-149 vote, largely along party lines.

Supporters of ‘right to try’ have argued that people with a terminal illness should have all tools at their disposal to try a drug that could possibly help them. But opponents of the effort have pointed to FDA’s compassionate use program, saying the agency approves 99 percent of requests to let patient use an experimental drug. They also said the bill provides a sense of “false hope,” since drug manufacturers aren’t required to provide the drug to patients who ask.

FDA Calls Out Drug Makers for Blocking Generics as Ryan Eyes CREATES Act Compromise

The Food and Drug Administration (FDA) has publicized a list of 41 branded drug manufacturers that have allegedly blocked access to drug samples in order to obstruct development of generic drugs. The list includes complaints about branded drug makers improperly using Risk Evaluation and Mitigation Strategy (REMS) requirements to restrict access to samples of branded drugs that are necessary to conduct FDA-required tests to demonstrate bioequivalence. In other instances, FDA claims branded drug companies may have placed restrictions in commercial agreements that limit the ability of distributors, wholesalers, or specialty pharmacies to sell samples. FDA Commissioner Gottlieb has said the agency is notifying the Federal Trade Commission (FTC) about the inquiries and encouraged generic companies to raise their cases with the Commission.

The announcement comes less than a week after the Trump administration released their broader drug pricing blueprint, and is part of an ongoing effort from FDA Commissioner Scott Gottlieb to spotlight anticompetitive behavior in the prescription drug market. Generic drug makers have been pressing Congress to pass legislation, known as the CREATES Act (S. 974), that would allow them to sue over these “gaming tactics.” To that end, House Speaker Paul Ryan (R-WI) indicated last week that the Energy and Commerce Committee and the Judiciary Committee are working out a compromise on the legislation that they hope to pass later this year. Despite having bipartisan support in Congress, previous iterations of the bill have stalled amid opposition from branded drug makers. 

CMS Releases Update to Drug Spending Dashboard

The Centers for Medicare and Medicaid Services (CMS) has released new data on the redesigned version of the Drug Spending Dashboards and the annual update to the Part D Prescriber Public Use File, changes that the agency says will help hold the drug industry accountable for price increases by making pricing more transparent. The Drug Spending Dashboards now include year-over-year information on the amount that CMS spends on drugs for Medicare and Medicaid, and highlights manufacturers that have increased their prices. In addition, CMS is expanding the dashboards to include a majority of the drugs prescribed under these programs. Specifically, the new Drug Spending Dashboards include a section for spending information for Medicare fee-for-service beneficiaries enrolled in Medicare Part B as well as drug spending and utilization information for Medicare beneficiaries enrolled in Part D. 

House Committees March Towards June Vote on Opioid Legislation

A pair of key House committees continued their work last week on a wide-ranging package of bills to address the opioid crisis, as Energy & Commerce Committee Chairman Greg Walden (R-OR) indicated that House leaders are reserving floor time for the package in June.  Both the Ways & Means and Energy & Commerce Committees held markups last week on opioid measures, setting the stage for their bills to be combined with legislation expected to come out of the Judiciary Committee. The Senate is simultaneously working on its own opioid package, with the goal of both chambers approving legislation by August recces.

The Energy & Commerce Committee has now approved 57 individual bills over the last two weeks focused on all aspects of the health care system, from increasing access to addiction treatment for Medicaid beneficiaries to building up the provider workforce and encouraging non-opioid treatments for pain.  Meanwhile, the Ways & Means Committee advanced seven bipartisan bills last week, most of which make modest tweaks to the Medicare program to prevent future misuse of prescription painkillers among seniors and to make addiction treatment more readily available to beneficia