What's the Fate of the BPCIA?

The Center for Biosimilars Staff

A new president may mean new rules.

A new president in the White House and health care rules and regulations in question (and under fire) could mean big changes for Big Pharma. But what’s next for the Biologics Price Competition and Innovation Act (BPCIA) when the now president-elect inherits the highest office in the land?

But practical realities and current Senate rules make it unlikely that the BPCIA would fall even if major changes to other aspects of the ACA did make it to President Trump’s desk.

The ACA contained provisions affecting many aspects of U.S. law, from Medicare to FDA to the healthcare workforce. Restoring pre-ACA law would require unraveling these far-reaching changes, and would likely result in a standstill as agencies scramble to write new rules and regulations. The BPCIA — which amended sections of the Public Health Service Act, the FFDCA, and the Patent Act, among others — is a good example.

Nor does it appear that President-elect Trump still wants a total repeal of the ACA, as Mr. Trump has recently backed away from his initial rhetoric, indicating room for compromise and the retention of certain aspects of the legislation. In particular, in an interview with the Wall Street Journal last week, Mr. Trump indicated that he would be open to a proposal that would maintain coverage for patients with pre-existing conditions, allow young adults to remain on their parents’ health plans until age 26, and even retain the controversial individual mandate, which requires all Americans to have health coverage or risk paying a fine.

In addition, Republicans might not have the votes needed in the Senate to repeal the ACA. Though Republicans will enjoy majorities in both congressional bodies next session, the GOP majority in the Senate is slim at just 52 seats. In other words, Republicans do not have a filibuster-proof majority, as 60 votes are needed to end any filibuster under current Senate rules. But Senator Harry Reid used the “nuclear option” in 2013, which eliminated the 60-vote supermajority to end filibusters on consideration of most presidential appointees, and he had further promised to do so again for Supreme Court nominees should Secretary Clinton have won the election and Democrats taken back the majority in the Senate.

There have been suggestions that Senate Republicans will at least consider a change in Senate rules to require only a simple majority to block a filibuster for some or all measures in the new Congress, perhaps including legislation. Although a change in Senate rules requires only a simple majority for approval, whether Republicans will further change or eliminate current Senate filibuster rules remains to be seen.