Alexandra Valenti, JD: The ACA and the Future of the BPCIA

Alexandra Valenti, JD, associate at Goodwin, discusses the future of the Biologics Price Competition and Innovation Act (BPCIA) in light of challenges to the Affordable Care Act.


So, the [Biologics Price Competition and Innovation Act, BPCIA] was enacted as part of the Affordable Care Act, and there was a recent successful challenge on constitutional grounds to the Affordable Care Act before a District Court in Texas. That decision is up on appeal now before the Fifth Circuit, and the Department of Justice has submitted a brief saying not only should the Fifth Circuit affirm that decision, but it should further find that provisions of the Affordable Care Act other than the individual mandate provision, which is the subject of the constitutional challenge, should be found to be not severable from the rest of the statute, meaning that if one provision of the statute goes down, so too the rest of the statute.

So, the question of whether the constitutional challenge to the Affordable Care Act has any effect on the BPCIA will hinge on that question of severability and whatever court makes the ultimate decision on this question, whether that be the Fifth Circuit or the Supreme Court in this case, finds that the individual mandate is severable from the rest of the statute. Of course, this doesn’t matter if the courts ultimately decide that the individual mandate provision is constitutional.

Interestingly, in the original challenge to the Affordable Care Act back in 2012, that was [National Federation of Independent Business v Sebelius], before the Supreme Court, President Obama’s Department of Justice submitted a brief that argued that the rest of the statute should not be found to be severable from the individual mandate because Congress would not have enacted the entire statute without the Individual Mandate Provision. So, it’s interesting to see the Obama administration and the Trump administration taking essentially the same position on the same issue.

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