• District of Columbia: On the 51st anniversary of the Roe v. Wade decision, the Biden administration announced new actions to protect patients' access to abortions and other reproductive services. HHS, along with the Department of Treasury and the Department of Labor, are planning to issue new guidance to expand access to no-cost contraception under the Affordable Care Act. The Office of Personnel Management is also expected to advance measures support access to contraception for federal workers, retirees, and their families, and HHS Secretary Xavier Becerra is sending letters to private and public insurers about their "obligations" to cover contraception benefits. "Abortion is healthcare. Contraception is healthcare. And healthcare decisions should be made by a patient with her doctor, not by politicians," Becerra said. "No American who believes in freedom should accept anything less." In addition to contraception access, HHS and CMS are working to raise patient awareness around the Emergency Medical Treatment and Labor Act (EMTALA), especially for people who are experiencing pregnancy loss or other related emergencies. (Firth, MedPage Today, 1/22; Garrison, USA Today, 1/22)
• Illinois: Blue Cross Blue Shield (BCBS) insurers have become the first to cover new multimillion-dollar gene therapies for sickle cell disease. In December, FDA approved the first of these new therapies, including BlueBird Bio's Lyfgenia and Vertex Pharmaceutical's Casgevy. Synergie Medication Collective, which is owned by BCBS, has entered into risk-sharing agreements with both Bluebird and Vertex. Through the deal, self-insured employers can pay BCBS plans a fee to cover sickle cell gene therapies for their employees through their stop-loss policies. "Our goal is to have an effective outcomes-based contract for every gene therapy on the market," said Synergie CEO Jarrod Henshaw. According to Modern Healthcare, other insurers and Medicaid agencies are also working on their own deals to cover the new treatments. Bluebird is also currently negotiating with CMS to include its treatment in a pilot program where federal regulators would broker payment agreements that could be used by all state Medicaid agencies. (Tepper, Modern Healthcare, 1/19)
• Maryland: FDA is requiring companies that manufacture CAR T-cell cancer therapies to add a boxed warning that the treatments themselves may also cause cancer. In November, the agency investigated whether CAR T-cell therapy could cause lymphoma, a blood cancer, following reports of CAR-associated T cell malignancies. FDA sent letters to five companies — Bristol-Myers Squibb, Juno Therapeutics, Janssen Biotech, Novartis, and Kite Pharma — requiring them to warn patients that "mature T-cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes." The companies have 30 days to submit proposed changes to their products' safety labels or a statement why they don't believe the changes are warranted. "Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, the FDA continues to investigate the identified risk of T-cell malignancy with serious outcomes, including hospitalization and death," FDA said. (Jewett, New York Times, 1/23; Bassett, MedPage Today, 1/24)

Maternal and reproductive healthcare is rapidly changing. Health leaders must grapple with worsening maternal health disparities, the nationwide maternal mental health crisis, lasting impacts of the Dobbs v. Jackson  ruling, and the rise of femtech disruptors. Download our report to learn about these four key drivers reshaping maternal and reproductive healthcare delivery.