HealthCare Roundtable e-News – November 18, 2020

Regulatory UPDATE: Part D Rule Banning Rebates Awaiting White House Budget Office Clearance

The Trump Administration recently finalized the regulation to end PBM-negotiated rebates in Medicare Part D and the rule is now awaiting final clearance by the White House Office of Management and Budget. The regulation, if it were to be finalized and not reversed by the incoming Biden administration or Congress, would not likely take effect any earlier than the 2022 plan year. 

The Roundtable strongly opposes this decision by the outgoing Trump Administration. In collaboration with our stakeholder allies, we will be posting a media statement and re-circulating our Issue Brief with key Hill offices as well as the Biden-Harris transition team to request that the decision be reversed.

We will be monitoring this issue closely and providing follow-up information in the coming days. Please do not hesitate to reach out to Andrew MacPherson, Roundtable Senior Policy Advisor, with questions:

Outgoing Trump Administration Looks to Move Forward with “Favored Nation” Rule to Lower Medicare Drug Prices

The Trump administration announced plans last week to move forward with the president’s “most favored nation” rule, despite opposition from pharmaceutical industry players. The rule, which Trump had signed amongst other executive orders earlier this year, will aim to lower certain Medicare drug prices to match prices in other wealthy countries. Prior to the election, the administration had been mum on the details of the executive order.

The rule proposes to lower certain Medicare drug prices in order to match the prices of the same drugs in other wealthy countries. The administration has not defined whether the rules will apply to drugs in just Medicare Part B or Medicare Part B and Part D. Republican lawmakers and those in the pharmaceutical industry are likely to oppose the rule, following arguments that the plan veers from traditional GOP free-market principles.

According to sources, it’s expected that the plans for the order are likely to come as an interim final rule, in which it will skip some of the steps in the regulatory process for a faster implementation. When asked about the plans, a spokesperson for the Department of Health and Human Services said the department does not have any announcements at this time.

Biden Sets Sights on Strengthening Obamacare, Cutting Drug Costs in New Term

In response to the Supreme Court hearings on the Affordable Care Act last Tuesday (Nov. 10), President-elect Joe Biden announced that the new administration would not give up on the law, regardless of the court’s ruling, and will get to work planning the expansion of Americans’ health care coverage. The case, California vs. Texas, could declare the ACA – or parts of the ACA — unconstitutional. The Trump administration has been vocal about its support for the 20 GOP attorneys general and governors and seeking to strike down the law.

“This effort to bypass the will of the American people, the verdict of the courts of the past, the judgments of Congress, in my view is simply cruel and needlessly divisive,” said Biden in response to the Supreme Court’s hearing last week. Biden announced that his transition team is in the process of planning how his administration will shore up the law and tackle lowering drug costs, but by the time he takes office in January, it could be too late to influence the court’s decision. (InsideHealthPolicy)

“The Biden administration’s options are pretty limited,” said University of Michigan law professor Nicholas Bagley. “It could drop the Justice Department’s support for the lawsuit, but that won’t make the case go away because the red state plaintiffs will still push it forward.”

Biden had promoted the work the Obama administration did to pass the ACA throughout his campaign and spoke of his support for expanding coverage, lowering seniors’ drug costs by closing the Part D donut hole, and covering pre-existing conditions. The president-elect will get to work on these priorities with his HHS transition team, headed by Chiquita Brooks-LaSure from Manatt, Phelps and Phillips, and Robert Gordon with the Michigan Department of Health and Human Services, according to the campaign’s transition website.

Biden Announces Members of COVID-19 Advisory Team

President-elect Joe Biden officially named the members of his COVID-19 Transition Advisory Board last week. Among the board members are former BARDA Chief Rick Bright, former FDA Commissioner David Kessler, former Surgeon General Vivek Murthy, and Yale Professor Marcell Nunez-Smith. Kessler, Murthy, and Nunez-Smith will serve as the board’s co-chairs.

“Dealing with the coronavirus pandemic is one of the most important battles our administration will face, and I will be informed by science and by experts,” Biden said in a statement Monday. “The advisory board will help shape my approach to managing the surge in reported infections; ensuring vaccines are safe, effective, and distributed efficiently, equitably, and free; and protecting at-risk populations.”

Biden plans to invest $25 billion in a vaccine manufacturing and distribution plan that guarantees a vaccine gets to every American cost-free, though the transition team has yet to comment on additional details of the plan. The president-elect also commented that this task force will look to consult with state and local health officials on how to best prevent coronavirus spread, reopen schools and businesses, and address the racial disparities that have left communities of color harder hit than others by the pandemic. (InsideHealthPolicy)

ICER Revises Recommended Price for Gilead’s Remdesivir Amidst WHO Solidarity Trials

The Institute for Clinical and Economic Review recently announced a lower recommended price for Gilead’s remdesivir, following results from the World Health Organization-funded Solidarity trial. Upon review of the trial’s results, remdesivir did not appear to reduce the death rate among COVID-19 patients. However, the trial results are currently awaiting peer review.

Back in October, the FDA granted the antiviral full approval for treatment of hospitalized COVID-19 patients and issued Fast Track and Priority Review designations, following the drug’s emergency use authorization earlier this year. In the United States, remdesivir’s price is currently capped at $3,120 per treatment course, but the institute’s updated ICER-COVID analysis recommends a base-case price of $2,470 per treatment course for patients with moderate to severe COVID-19 and $70 per treatment course for hospitalized patients with mild symptoms. (InsideHealthPolicy)

ICER had stated that while the WHO Solidarity trials are major contributors to the analysis, there are components of the trial for which the institute has requested more clarity before the results of the study can be determined. The institute, however, acknowledged that the size of the Solidarity trial and the consistent failure of remdesivir to showed enough evidence to warrant an updated analysis. (InsideHealthPolicy)