Association Details Why BPCIA Should Stay Even If ACA Falls


The Association of Accessible Medicines (AAM), which supports biosimilar development, argues that even if the Affordable Care Act (ACA) is overturned by the Supreme Court later this year, the Biologics Price Competition and Innovation Act (BPCIA) is severable and should survive.

This month, briefs were due in the Supreme Court, which in March agreed to review the decision of the Fifth Court of Appeals in California v. Texas (originally Texas v. Azar) over the constitutionality of the Affordable Care Act (ACA).

One of those briefs, filed by the Association of Accessible Medicines (AAM), which supports biosimilar development, argues that even if the ACA is deemed unconstitutional, the Biologics Price Competition and Innovation Act (BPCIA) is severable and should survive, noting it has strong bipartisan support.

Last December, the Fifth Court struck down the individual mandate—the heart of the ACA—and sent the case back to the federal district court in Texas to determine whether other parts of the law, such as provisions to require plans to cover pre-existing conditions, are constitutional and can exist without the mandate. However, the justices agreed to fit the case into its schedule beginning in October 2020, after refusing to hear it on an expedited basis by June.

Writing in To the Point, a column of The Commonwealth Fund, Timothy S. Jost, emeritus professor at the Washington and Lee University School of Law, summarized the main points of the briefs that were filed by May 13. Most stress that if the ACA is overturned, the damage to the United States—now already reeling from the effects of the coronavirus disease 2019—would be catastrophic.

If the entire ACA is overturned, up to 20 million Americans could lose health coverage, and alternative payment systems on which the health care industry has some to rely on for both quality and value would be shredded, among other things.

A few of the amicus briefs address specific provisions of the ACA unrelated to the mandate and health insurance and urge that their own provisions of interest in the 2010 landmark law should stand. The AAM is one of those.

“FDA-approved biosimilars offer patients and taxpayers enormous cost savings on life-saving treatments,” says the organization’s interim CEO and general counsel, Jeff Francer, in a statement. “If a constitutional challenge to some provisions of the Affordable Care Act (ACA) resulted in the invalidation of the entire ACA, including the BPCIA, a decade of progress by AAM and its members would be lost—and at a crucial moment.”

In its brief, the organization says that biosimilars are expected to save at least $54 billion for patients and health care systems over the next 7 years. Throwing the BPCIA out with the ACA would mean that the FDA would lose its approval to streamline biosimilar approvals and corporations would lose the investments they have made in this industry.

“The BPCIA is exactly the type of legislation that should not be declared invalid based on a constitutional challenge to another part of the same public law,” the brief argues. “The BPCIA stands on its own and serves an important public purpose that is entirely disconnected from the insurance-related provisions of the ACA that are challenged here."

States, including the plaintiffs, benefit from lower drug costs, they note; spending on name-brand, originator biologics increased by 65% between

2011 and 2016. States have benefitted from the BPCIA and have not been injured, and therefore have no standing to challenge the provision. The brief also criticized the plaintiffs for saying that the all provisions of the ACA are “minor.” "That is not remotely accurate as a description of the BPCIA, an important and independently justified piece of legislation that stands on its own," the brief says.

Moreover, the BPCIA also includes a framework by which biologic and biosimilar manufacturers can attempt to work out patent disputes before a biosimilar launch, the brief says; that process reduces litigation costs.

In addition, the BPCIA “passes every test for severability,” AAM says. Even ACA opponents are in favor of the BPCIA, the brief says.

The plaintiffs are led by Texas, which argue that the ACA can be severed from the individual mandate, which was rendered moot by the Tax Cuts and Jobs Act of 2017, as it was zeroed out. Texas and other Republican-led states sued HHS in 2018, arguing that the ACA cannot be “severed” from the mandate and the entire law must be invalidated, stemming from the fact that in 2012, the high court had invalidated the ACA’s individual mandate as a legal obligation but upheld it as a tax.

A group of Democratic states led by California and the House of Representatives have intervened to defend the law, which the Trump administration has refused to defend.

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