Insights

In a somewhat ambiguous press release on Wednesday, June 18, 2025, the Food and Drug Administration (FDA) announced a halt and “immediate review” of new clinical trials where American patients’ cells are sent to China or other “hostile countries” for genetic engineering with the expectation that the cells will be infused back into U.S. patients.[1] A subsequent podcast published by the agency also said that therapies that involved cells that were sent to China for genetic engineering and intended for subsequent infusion into U.S. patients would not be approved going forward. The announcement said that there is “mounting evidence” that some clinical researchers failed to obtain informed consent from trial participants about the international transfer and manipulation of biological material.

Since his inauguration on January 20, 2025, President Trump has issued a flurry of executive orders (“EOs”). Three of these EOs rescind Biden Administration guidance extending the nondiscrimination protections under Section 1557 of the Affordable Care Act (the “ACA”) to discrimination based on gender identity.[1] These protections have had a tumultuous history since Section 1557 was enacted in 2010, with each administration reversing course from the last. The new administration has reverted to the position taken in President Trump’s last presidency – that the protections against discrimination “on the basis of sex” do not apply to gender identity.

Artificial intelligence is now a mainstay in our daily lives. It’s in our phones and computers. It helps us draft emails and learn math. It recommends purchases and guides our online searches. It’s everywhere—and every sign suggests that it’s here to stay.

Digital health companies, investors, and other healthcare organizations should follow policy developments with a strategic lens towards their market opportunities for key potential growth and risk mitigation. On a quarterly basis, we provide relevant legislative and regulatory updates on artificial intelligence (AI) and digital health policy developments.

On May 10, 2024, the Centers for Medicare & Medicaid Services (“CMS”) published a Final Rule that, for the first time, imposes national minimum nurse staffing requirements for nursing homes. Specifically, the standard adopted by CMS requires minimum staffing of 3.48 hours per resident day (“HPRD”), as discussed in more detail below. CMS estimates that the new requirements will cost facilities $43 billion over the next 10 years, which is more than the $40.6 billion cost that CMS estimated for Proposed Rule of 3.0 HPRD. Some industry sources estimate that less than 25% of nursing facilities across the country currently meet the full scope of staffing standards laid out in CMS’ Final Rule due to a myriad of factors including labor shortages and increasing wage pressures. Indeed, the impact and cost of these staffing requirements will vary significantly by state. For example, CMS reported that at least one state will need to increase certain staff by nearly 96% to meet the minimum standards, while other states already meet the requirements.

Last week, Ranking Member Bill Cassidy (R-LA) of the Senate Committee on Health, Education, Labor and Pensions (“HELP”) issued two separate requests for information (“RFIs”) asking for stakeholder feedback on artificial intelligence (“AI”) and health data privacy policy issues to identify current challenges and receive recommendations to inform potential legislation.  With deadlines set for the end of September, each RFI provides a short window for organizations to submit comments.

On December 29, President Joe Biden signed into law the Consolidated Appropriations Act, 2023 (P.L. 117-164) (the “Act”)—an approximately $1.7 trillion spending package, which consists of all 12 fiscal year (FY) 2023 appropriations bills and funds the federal government through September 30, 2023, provides additional assistance to Ukraine, and makes numerous health care policy changes.  

Today, President Biden signed an executive order and published a presidential memorandum seeking to improve access to the health insurance markets created by the Affordable Care Act, reverse certain Trump Administration healthcare policies, and to protect access to reproductive health services. The action comes on the seventh business day since the administration took office, a day dedicated to addressing broad healthcare issues, as opposed to the more acute pandemic measures that were taken on days one and two. Although not sweeping policy changes, President Biden signals ownership of the Affordable Care Act, which he as President Obama’s vice president shepherded, and rings in a new era of leadership that seeks to strengthen the law rather than repeal and replace it. The following is a summary and link to each of today’s actions:

The House and the Senate introduced a bipartisan bill that would lift the restrictions on the provision of telehealth and remote patient monitoring (RPM) services, with the goal of cost savings and improved quality of care. On Tuesday, February 2, 2016, Democrat and Republican lawmakers from both chambers introduced the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act (S. 2484, H.R. 4442).1 

The "what will Congress do" news leads can now stop. The Supreme Court issued its decision in King v. Burwell and Congress does not need to fix anything because, by a vote of 6-3 in an opinion written by Chief Justice John Roberts, the Supreme Court held that the subsidy provisions of the ACA are not broken, and that individuals who purchase insurance through the Federal Exchange are eligible for ACA subsidies. In a nutshell, the Court held that the most reasonable reading of the ACA provision making credits available to individuals who purchased insurance on an exchange "established by the State" makes tax credits available to individuals who purchased insurance through the Federal Exchange. The decision delves deeply into health insurance policy concepts as well as the dark-art of statutory interpretation and the underlying chaotic legislative process to find, ultimately, that it was "implausible" that Congress intended to limit tax credits to individuals who purchased insurance through a State Exchange. See King, 576 U.S. __ (2015), slip op. at 17.

This summary of key lawsuits affecting managed care is provided by the Health Care Group of Crowell & Moring. If you have questions or need assistance on managed care law matters, please contact Chris Flynn, Peter Roan, or any member of the Health Care Group.