Yesterday, the Supreme Court heard arguments on the constitutionality of the Affordable Care Act (ACA). Here’s what we know about the case so far and what the outcome means for the biotech industry.
The case: Brought to the Supreme Court by the Trump administration and Attorneys General from several Republican states, California v. Texas challenges the constitutionality of the individual mandate and calls for the entire law to be struck down.
With a 6-3 conservative majority on the court, it's thought that the individual mandate could be at risk.
However: “Chief Justice John Roberts and Justice Brett Kavanaugh, one of the three justices on the court appointed by President Trump, both signaled they disagree with arguments from Republican-led states that Obamacare should fall if its individual mandate is deemed unconstitutional,” reported CBS News.
“If the Court strikes down the ACA in its entirety, 20 million people would lose health insurance, a variety of protections for people with pre-existing conditions would be eliminated, and an extensive set of policies affecting Medicare, Medicaid, prescriptions drugs, and other parts of the health care system would be reversed,” explains Brookings.
A few other things would happen if the Court strikes down the entire law:
The Medicare Part D “donut hole” coverage gap would be reopened—creating chaos for seniors, insurance companies, and manufacturers. (The ACA eliminated the “donut hole.”)
The Center for Medicare and Medicaid Innovation (CMMI) would be eliminated. Both President Obama and President Trump used CMMI to drive proposed changes to Medicare payment policies.
This would also strike the Biologics Price Competition and Innovation Act (BPCIA), which creates an approval pathway for biosimilars.
Without BPCIA, “[n]ew approvals would immediately cease, and the status of 28 biosimilars currently approved would be uncertain,” explains Brookings. “Manufacturers of the approved products would not know if it was legal to continue making their products, pharmacies would not know if they could legally dispense them, and patients would not know if they would continue to have access to them in place of higher-priced brand name biologics. Moreover, further litigation on this question seems likely, extending the period of uncertainty.”
So, what’s next? “[T]hough the majority of justices on Tuesday appeared unlikely to side with the Trump administration and red state arguments that the entire law should be struck down, the uncertainty will hang over health care markets possibly through spring. And if Republicans keep control of the Senate and the law is struck down, Democrats’ hopes for passing a replacement would be quashed,” says Yahoo! News.
More Health Care News:
FDA: FDA offers guidance to enhance diversity in clinical trials, encourage inclusivity in medical product development
“This guidance offers recommendations on how product sponsors can improve clinical trial diversity by accounting for logistical and other participant-related factors that could limit participation.”
STAT News: The story of mRNA: How a once-dismissed idea became a leading technology in the COVID vaccine race
“There are about a dozen experimental vaccines in late-stage clinical trials globally, but the ones being tested by Pfizer and Moderna are the only two that rely on messenger RNA.”
The Hill: Fauci says he trusts Pfizer, will take vaccine if FDA approves it
“Asked by MSNBC's Andrea Mitchell whether he would take the vaccine, Fauci replied, ‘Well, I'm going to look at the data, but I trust Pfizer, I trust the FDA. These are colleagues of mine for decades, the career scientists.’”
