Ruling preserves preventive care coverage for now. Source: NPR - edited for brevity.

The Supreme Court has upheld a key provision of the Affordable Care Act (ACA), ensuring, at least for now, that some 150 million people will continue getting many free, preventive services under the act. The vote was 6-3, with Chief Justice John Roberts, and Justices Amy Coney Barrett and Brett Kavanaugh joining the court's three liberal justices in the majority.

Siding with the government on Friday, the court upheld the ACA, allowing the U.S. Preventive Services Task Force to continue determining which services will be available free of cost to Americans covered by the ACA. 

At issue in the case was a lawsuit that sought to undo the preventive care provision by challenging the appointment process for members of a 16-person task force that determines which preventive services are to be provided for free under insurance policies. Two lower courts found that the appointments were unconstitutional, but on Friday, the Supreme Court disagreed.

Writing for the court majority, Justice Kavanaugh said the Department of Health and Human Services has the power to appoint members of the task force. "Task Force members are supervised and directed by the Secretary, who in turn answers to the President, preserving the chain of command in Article II," Kavanaugh wrote.

The ACA's preventive treatments have benefited millions of people since the health care law went into effect 11 years ago — a sufficiently long time for most people to take the free coverage for granted. Activists argued that if the court ruled for the groups challenging the law, the benefits could disappear.

The case arose when the preventive care task force classified pre-exposure prophylaxis (PrEP) drugs as essential to preventing HIV. Preventive PrEP coverage under the ACA includes not only HIV testing and medication, but also clinic visits and lab testing without added cost-sharing. Without ACA coverage, PrEP care would be astronomically expensive for most Americans.

The suit was brought by individuals and businesses with religious objections to the PrEP mandate—they claimed that providing PrEP coverage encourages "sexual behaviors and drug use" antithetical to their Christian beliefs. Braidwood Management, the case's named plaintiff, is led by Republican mega donor Steven Hotze who has referred to members of the LGBTQ+ community at different times as "morally degenerate," "satanic," and "termites." Hotze, has challenged the ACA in at least two other federal lawsuits.

The court's decision on preventive care likely will protect other existing preventive services under ACA, including treatment for blood pressure screenings, as well as birth control, breast and lung cancer screenings, immunizations, and more.

Most experts expect future lawsuits to be filed regarding this and other ACA related functions so while the court ruling upholds the coverage of preventive care for free, it may not be the last word on the subject.

Use of Artificial Intelligence in Decisions on Medical Products from Pharmaphorum website 1/25

The US Food & Drug Administration has published its first provisional guidance on the use of Artificial Intelligence technology in regulatory filings due to the exponential increase in the use of AI in drug development and regulatory submissions since 2016. AI is increasingly being used to generate data or information on the safety, effectiveness, or quality of a drug or biological product.

The draft guidance – which is open for comment until 7th April – proposes a risk-based assessment framework drug developers can use to establish the credibility of an AI model for its intended use. Examples may include predicting patient outcomes, improving understanding of predictors of disease progression, and analyzing large datasets from sources like real-world studies or digital health technologies.

At the heart of the guidance is the concept of 'context of use' (COU), which defines how an AI will be used to address a "question of interest," according to the document. It describes a risk-based framework for sponsors to assess and establish the credibility of an AI model for a particular COU and communicate that to the regulator.

According to the FDA, it draws on the reviews it has carried out on drugs and biologics with AI components in recent years, but – with the technology still in its infancy – the agency recommends that sponsors engage with it early on in the development process to get feedback on credibility. 

Click here to read the draft and/or comment on it. 

Sponsored by National Organization of Rare Disorders

February 25, 2025 - Albany, NY

Rare disease community members from across the state gather in Albany to:

• attend a legislative breakfast

• host a rare disease awareness public display

• ask Legislators to create a permanent New York State Rare Disease Advisory Council 

• support a New York State rare disease awareness resolution

Room & Travel scholarships are available. Register today to secure your place!   

Click here to register!

March 17, 2025 - Albany, NY 

People with bleeding disorders like Von Willebrands Disease, Platelet Disorder, and Hemophilia from across New York State along with their family members assemble in Albany for a program of advocacy training and meetings with Legislators plus a public awareness display in the state capitol complex.

For more info on NYSBDC: https://www.nysbd.org/