Ruling could affect preventive care coverage. Source: Politico - edited for brevity.

Friday the Supreme Court agreed to hear a broad challenge to the Affordable Care Act’s coverage of preventive services in this term, the latest in more than a decade of battles over the health reform law. A negative ruling  would erode the coverage of tens of millions of people who get their health insurance from their employer or through Obamacare’s marketplace, removing requirements that insurers cover the full cost of everything from birth control to vaccines to mental health and other screenings.

The lawsuit centers on experts that advise HHS which services must be covered without cost-sharing, and contends the panels are unconstitutional because their members are not confirmed by the Senate nor chosen by a Senate-confirmed agency head. It also argues certain requirements, such as insurance coverage of the HIV prevention drug PrEP and “certain contraceptives violate the religious rights of employers.

Lower courts have backed the challengers on some of these points. The 5th U.S. Circuit Court of Appeals in New Orleans ruled this summer that the U.S. Preventive Services Task Force is unconstitutional. But the appeals court declined to enforce its ruling nationwide and declined to issue similar decisions against the Advisory Committee on Immunization Practices or the Health Resources and Services Administration — the panels that recommend which vaccines, contraceptives and other preventive services must be covered by insurance.

The Supreme Court’s action raise the question if lawyers for the Trump administration will stand by the previous ACA position or not to defend panels that set the coverage requirements under the Affordable Care Act, which Trump has roundly criticized. If the Justice Department doesn’t defend the arrangements, it’s possible the high court could appoint another lawyer to do so.

The federal government and challengers have been operating under a compromise while they await a decision from the Supreme Court: Obamacare’s insurance requirements will remain in place nationwide, but the government cannot enforce them against the Texas plaintiffs in the case.

The case is likely to be set for argument in March or April and decided by the end of June.

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/