PhRMA Challenges Trump's GLOBE Rule on Medicare Drug Prices, Calls It Illegal Overreach
New York: The pharmaceutical industry's top lobby group on Wednesday sued to invalidate one piece of the Trump administration's efforts to benchmark US drug prices to lower costs overseas in the Medicare health insurance program, arguing that it is an illegal overreach by the US government.
The GLOBE rule intends to set hospital drug prices for Medicare patients. Its final version was published last week on exactly how a "most favored nation" pricing system based on what is paid in a group of comparable countries would be integrated in the Medicare Part B program.
The rule is expected to have limited reach. CMS plans to waive it for manufacturers that have signed separate voluntary deals with the White House to cut prices for their drugs, and it could ultimately apply to as few as four drugmakers.
The PhRMA lobby group filed its lawsuit in the US District Court for the District of Columbia against Health Secretary Robert F. Kennedy Jr., the US Department of Health and Human Services he runs, and the Centers for Medicare & Medicaid Services and two of its officials.
The lobby group argues in its lawsuit that CMS, Medicare's regulator, has stretched the authority of a program to test new pricing ideas into rewriting Medicare's pricing structure without congressional action.
Congress has given CMS "a little bit of authority to test models," PhRMA General Counsel Jim Stansel said in an interview. "Instead, CMS is doing exactly what Congress has declined to do multiple times over the last several years, and that's to replace the pricing structure in Medicare with a most-favored-nation structure."
Stansel said that the lawsuit was important even with the limited reach of the rule because GLOBE could outlast the voluntary deals drugmakers have signed, and could extend to future administrations beyond Trump.
Rachel Turow, an attorney with Skadden who is not involved in the lawsuit, said it can be viewed as an attempt to stop future price controls using similar mechanisms.
If they don't foreclose the idea that you can use this process "to impose drug pricing controls, then they've basically opened the floodgates," Turow said.
Medicare is the US government program that provides health coverage to about 70 million people aged 65 and older or with disabilities.
The Department of Health and Human Services was not immediately available to comment on the lawsuit. In the finalized version of the rule, however, the agency argued that it was not overstepping its bounds, writing, "CMS is acting within a detailed, purpose specific statutory framework that Congress designed precisely for this type of model test."
Trump has already signed deals with more than two dozen drugmakers, including many of the world's largest, such as Pfizer, Eli Lilly and Novo Nordisk.
The final rule sharply reduced the government's projected savings from the model. HHS now estimates the program will reduce Medicare Part B spending by about $440 million over the 7-year model period, compared with roughly $11.9 billion projected in the proposed rule published last year.
In 2020, PhRMA successfully sued to block a previous incarnation of most-favored-nation pricing, but that rule was invalidated on procedural grounds because the administration had rushed it out without giving the public a chance to comment.
Also named in the suit were CMS Administrator Dr. Mehmet Oz, the agency's innovation center that is running the most-favored-nation pricing pilot and the director of that division, Abe Sutton.
