A federal judge in Maryland has temporarily blocked a Trump executive order that tied Medicare reimbursement for several drugs to lower rates in other countries.
The executive order was facing a flurry of lawsuits.
U.S. District Judge Catherine C. Blake sided with the plaintiffs’ argument that the Department of Health and Human Services (HHS) did not allow a public comment period when finalizing the rule and granted a temporary restraining order against the pricing scheme.
The plaintiffs in the case included the Association of Community Cancer Centers (ACCC) and the Pharmaceutical Research and Manufacturers of America (PhRMA) trade association, among others.
The executive order was slated to go into effect on Jan. 1, 2021.
Centers for Medicare and Medicaid Services (CMS), an HHS department, had published an advance notice of proposed rulemaking in 2018, but later withdrew it as the president sought to pass legislation to address high drug pricing.
The government later tried to bypass the public comment period, claiming it had a “good cause” to do so. In particular, the government argued that the COVID-19 pandemic contributed to a Medicare drug-pricing emergency.
Judge Blake disagreed, stating the government’s plan to use the good cause exception “falls flat,” and arguing the government did not explain how Medicare recipients would see short-term economic relief.
CMS published an update of its pricing scheme for 50 Medicare Part B drugs with international pricing controls on Nov. 27. The plan would add more drugs over a seven-year timeframe. The government projected the plan would cut Medicare spending in the first year by almost $5 billion.
“Because the government is protected by sovereign immunity and no monetary damages are available, these severe economic losses can qualify as irreparable harm,” concluded Judge Blake in her opinion.