Today, the U.S. Supreme Court rejected a challenge to the U.S. Food and Drug Administration (FDA) approval of the drug mifepristone, which is used as part of a two-drug protocol to induce abortion. The Court ruled that the providers seeking to overturn the FDA approval did not have standing, because the providers were not directly
Health Plan Compliance
Final HIPAA Privacy Rule Increases Protection of Reproductive Health Care Data
The Office for Civil Rights (“OCR”) at the Department of Health and Human Services (“HHS”) recently issued final regulations (“Reproductive Health Care Rule”) under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) that narrow the permitted uses and disclosures of protected health information (“PHI”) in the context of an individual seeking, obtaining, providing…
Agencies Update Guidance on Group Health Plan Contraceptive Coverage Requirements
The Departments of Labor, Treasury, and Health and Human Services (the “Departments”) recently issued guidance for group health plans outlining a “therapeutic equivalence” medical management technique for required preventive services coverage of contraceptives. The guidance, which was issued in the form of FAQs that can be downloaded here, builds on previous FAQs addressing required…
Transparency in Coverage Rules: When Accurate Estimates for Low‑Utilization Items and Services Are Not Available
Last week, the Departments of Labor, Treasury and Health and Human Services (“the Departments”) issued an FAQ about the final Transparency in Coverage rules (“TiC Rules”). This FAQ addresses compliance with cost‑sharing disclosure requirements where a plan is providing cost estimates based on claims data but there is extremely low utilization of the item or…