Health Policy Report

The Week in Review

Both chambers of Congress were on a brief recess. Congress will start a three-week work period on Monday before another recess for Memorial Day at the end of the month.

The Week Ahead

The House’s work this week features a Senate-passed Congressional Review Act (CRA) resolution (S.J. Res. 57) that would nullify guidance issued by the Consumer Financial Protection Bureau (CFPB) regarding auto lending. The most consequential element of the measure is that it will repeal agency guidance, as opposed to a rule, which sets a new precedent for congressional oversight of regulations. Only one Democrat, Sen. Joe Manchin (D-WV) voted in favor of the resolution in the upper chamber and it is expected to be considered along partisan lines in the House as well.

Other items on the House docket include a bill that would require the Department of Justice to release information on their grant programs for state and local governments on pretrial release programs (H.R. 2152), a measure to change the way the Federal Trade Commission (FTC) considers mergers (H.R. 5645), and a bill that would set policy for used nuclear fuel, including at the controversial Yucca Mountain site in Nevada (H.R. 3053). The nuclear waste measure has broad support after being approved by the Energy and Commerce on a 49-4 vote last June, but has faced vocal opposition from Nevada lawmakers who argue that the Silver State is bearing too heavy of a burden for the nation’s nuclear energy production.

In the Senate, Majority Leader Mitch McConnell (R-KY) has teed up another judicial confirmation blitz, with six high-level federal judges expected to be voted on this week. The process starts today with a cloture vote due on the nomination of Kurt Engelhardt to join the 5^th Circuit Court of Appeals. Much to the chagrin of Democrats, the rate of federal judicial confirmations during the Trump Administration has far outpaced that of recent presidents, partly due to the abandonment of the 60-vote threshold for judicial nominees in 2013.

Outside of Washington, major primary elections will be held for Senate and House races in a handful of important states – Indiana, North Carolina, Ohio, and West Virginia – for this fall’s midterms. The West Virginia Republican primary for a candidate to compete against Sen. Joe Manchin (D-WV) will be watched particularly closely as establishment candidates battle against the controversial coal executive Don Blankenship.

Gottlieb Alludes to Forthcoming Action on Drug Rebates in Speech 

Wednesday, Food and Drug Administration Commissioner Scott Gottlieb signaled that the government could consider changing the federal anti-kickback law to remove protections for drug rebates. He blamed the rebates between payers and manufacturers for driving higher list prices, and said the government should “reexamine the current safe harbor for drug rebates under the Anti-Kickback statute” in an attempt to restore “some semblance of reality to the relationship between list and negotiated prices.” Gottlieb caused confusion among the health care industry with his comments, and many have argued that Gottlieb likely meant that rebates should be considered kickbacks. They say the Commissioner intended  to imply that this would force plans and pharmacy benefit managers to use up-front discounts instead. Drug makers disagree, however, calling for a much less drastic interpretations of Gottlieb’s comments.

The comments were made in reference to President Trump’s highly anticipated, upcoming speech on drug prices, and Gottlieb said the president’s plan will be focused on dismantling provisions that shield parts of the drug industry from competition. Health and Human Services Secretary Alex Azar also mentioned last week that Trump will announce a series of changes to the pricing mechanisms in Medicare Part D, and will likely go beyond what was laid out in his budget proposal. The President’s speech Is expected to take place on May 11.

Conservative Groups Huddle ACA Replacement

In an effort led by the Heritage Foundation, the Galen Institute, and former Sen. Rick Santorum (R-PA), conservative Republicans hope to release a new Affordable Care Act replacement plan at the end of the month. The plan would include block grants to the states funded by taking money currently being spent on ACA subsidies and Medicaid expansion, but would not cap Medicaid spending. Many of the plan’s details have not yet been worked out. 

The bill would likely dead-on-arrival upon introduction, as House leadership has made clear they will not move again on ACA efforts this year, and the Senate does not have the votes to pass such a bill. Heritage Foundation Leadership acknowledged “disinterest” in the bill in Congress, but noted they could use the legislation to push for an outside repeal effort.  The White House has announced that they support the coalition effort to address the “Obamacare disaster.”

Key House Panel Sets May 17 Deadline to Advance Opioid Bills

The House Energy and Commerce Committee announced last week that it would hold markups over the next two weeks to advance legislation aimed at tackling the opioid epidemic to the House floor. The proposed markup was divided up over two weeks to appease House Democrats who claimed Republicans were moving too fast on the issue. The markups will split a yet-to-be-announced list of opioid specific bills between a markup on May 9^th and one next week on May 17^th. The list of included bills and markup timing will be announced Monday, May 7^th. Committee Chairman Greg Walden hopes to put opioid legislation on the House floor by Memorial Day.

New CMMI Director Pledges to Add ‘Value’ Without Increasing Risk

The Center for Medicare and Medicaid Innovation Director Adam Boehler said last Thursday that he would use his new role to reduce regulatory burdens, promote better sharing of data, and encourage value-based care through models that would not involve providers taking on more risk. He noted that risk may add value, but that there were other ways to increase value such as improving quality and outcomes. He suggested that small, incremental changes will bring major accomplishments in added value, rather than new big payment models. Director Boehler explained CMMI will judge its work by its ability to achieve three big goals – improving the affordability of health care, as well as its quality and access. He also mentioned the agency would pursue improvements in increasing transparency around CMMI reasoning. Little was previously known about the new director’s priorities for the CMMI as he had not held a government position or given many public statements before arriving in his role.

NIH Announces Largest Longitudinal Study on Determinants of Health

The National Institutes of Health (NIH) has announced the launch of the All of Us program, which is a key element of NIH’s Precision Medicaid Initiative (PMI). All of Us seeks to collect data from at least one million people with diverse lifestyles, environments and biological makeup to inform studies addressing a wide range of health conditions. At the World Health Congress in Washington, D.C. last Wednesday, Department of Health and Human Services (HHS) Secretary Alex Azar noted that the program will gather data on everything from lifestyle and nutrition to genetics and healthcare outcomes, so that the NIH and HHS may better understand the determinants of health.

The All of Us research program will open national enrollment on May 6, and will mark the occasion with community events in seven major cities, as well as an online event. The program is open to all individuals over the age of 18 to enroll regardless of health status. More than 25,000 participants are already enrolled in the program after participation in a year-long beta test before the national launch. The NIH is emphasizing enrollment in underrepresented communities in the effort to make the research project one of the largest, most diverse resources of its kind.