Tony Hagen is senior managing editor for The Center for Biosimilars®.
Under the Biden administration, the Department of Justice (DOJ) has reversed course and now backs the constitutionality of the Affordable Care Act (ACA).
The Department of Justice (DOJ) has changed its position on the Supreme Court case involving the severability of the individual mandate from the Affordable Care Act (ACA), now arguing that the ACA should not be struck down if the mandate is deemed unconstitutional.
Under the Trump administration, the DOJ argued the mandate was not severable, but under President Joseph Biden the federal argument is now different. Oral statements were held before the Supreme Court in November 2020 whether the entire ACA should be invalidated. A decision is expected in June.
The Trump administration had sided with Republican-governed states led by Texas that had argued against severability and for the invalidation of the ACA.
The significance for biosimilar markets is that if the ACA is allowed to stand, the biosimilar regulatory approval pathway, or Biologics Price Innovation and Competition Act, which is part of the ACA, will remain also.
The DOJ position was outlined in a letter filed by Deputy Solicitor General Edwin S. Kneedler. “The purpose of this letter is to notify the court that the United States no longer adheres to the conclusions in the previously filed brief of the federal respondents,” Kneedler wrote. “After reconsideration of the issue, it is now the position of the United States that the amended Section 5000A [individual mandate] is constitutional.”
The individual mandate was amended so that individuals do not have to pay a penalty if they do not have coverage for themselves.
Kneedler went on to say that if the Supreme Court decides that the altered section is unconstitutional, it is the DOJ position “that provision is severable from the remainder of the ACA.”
The Biden administration has promised to strengthen Obamacare by improving access to coverage and medical care for residents of the United States.