President Trump Signs Executive Order on Women’s Health

On Monday, October 19, President Trump signed an executive order to create a new division in the National Institutes of Health (NIH), the Women’s Health Division, and create a task force on women’s healthcare issues. Within 90 days, the new Women’s Health Division will begin operations and work with the existing Office of Research of Women’s Health to support research that addresses conditions that primarily or disproportionately impact women’s health. The new division will prioritize research on cancer, endometriosis, fibroids, polyendocrine metabolic ovary syndrome (PMOS), osteoporosis, menopause, infertility, cardiovascular disease, cancer, and other conditions. The task force on women’s health will be jointly led by Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and White House Chief of Staff Susie Wiles. It will include leaders from the FDA, CMS, CDC, and other agencies. The task force is authorized to implement pilot programs that incentivize the integration of prevention, early intervention, and treatment of disease with the goal of removing silos between agencies, programs, and systems (Inside Health Policy, October 19).

CMS Proposes Rule on Medicare Advantage Provider Directories, PBM Transparency, and Dual Eligible Copayments

On October 16, CMS released a proposed rule (CMS-4214-P) to implement certain provisions of the Consolidated Appropriations Act, 2026, specifically:

• Section 6219: Eliminates the $1 generic drug copayment for full-benefit dual-eligible beneficiaries at or below 100% of the Federal Poverty Level, beginning in plan year 2028.
• Section 6220: In alignment with the Requiring Enhanced and Accurate Lists of Health Providers (REAL Health Providers) Act, beginning in calendar year (CY) 2028, Medicare Advantage (MA) organizations would be required to verify and update provider directories at least every 90 days (annually for acute inpatient hospitals, critical care services, and surgical services), publish accuracy scores, and disclose network, provider group, and ownership information in a public, machine-readable format. Enrollees who receive out-of-network care because of an inaccurate directory would be protected from higher cost sharing. CMS proposes codifying these requirements by CY2029 and adding “cultural and linguistic capabilities” as a directory element, though further clarity is needed on what this includes.
• Section 6224: Regulates pharmacy benefit manager (PBM) payments in Medicare Part D by limiting compensation to bona fide service fees based on fair market value rather than drug costs. PBMs would also be required to apply consistent definitions and methodologies in price guarantees and report compensation and cost performance data annually to plan sponsors and CMS. The rule also seeks funding disallowances for violations of remuneration requirements.

If finalized, the rule would improve the accuracy of MA provider directories, increase PBM transparency, and lower prescription drug costs for some low-income Medicare beneficiaries, with key provisions starting in 2028. The proposal is open for public comment for 60 days. It is designed to align with the National Provider Directory (NPD) that CMS is developing, a centralized, public-facing repository for provider directory data (Inside Health Policy, October 16; Inside Health Policy, October 16; CMS, October 16; CMS, October 16).

DOJ Issues Policy to Streamline Self-Disclosure of Criminal Healthcare Fraud

The Department of Justice (DOJ) issued a new policy on voluntary self-disclosure protocol for criminal healthcare fraud on October 15. Companies will now only need to disclose the conduct to the Fraud Division to receive the benefit of both the DOJ’s Corporate Enforcement Policy and the Health and Human Services Office of Inspector General (HHS-OIG) Health Care Fraud Self-Disclosure Protocol. The agencies hope to streamline the disclosure of criminal conduct and promote accountability, transparency, and integrity. The HHS-OIG has also updated its policy to reflect the changes that have made the DOJ’s Fraud Division the single point of contact. The DOJ may still prosecute some companies that self-disclose but do not qualify as voluntary. However, these companies will see reduced penalties according to the DOJ’s recent corporate reporting policy memo (Modern Healthcare, October 19).