National
CMS Expands Therapies Under Cell and Gene Therapy Access Model. Last Tuesday, the Centers for Medicare & Medicaid Services (CMS) Innovation Center announced it was expanding the scope of the Cell and Gene Therapy (CGT) Access Model beyond sickle cell disease. Under the model, CMS negotiates outcomes-based arrangements with cell and gene therapy manufacturers for state Medicaid programs. The expansion follows positive results from the model’s first evaluation report. In the coming months, CMS is expected to release a Request for Applications for manufacturers to begin negotiations for other FDA-approved therapies and other therapies pending FDA approval or licensing, once they receive approval.
CMS Releases Schedule for Medicaid and CHIP Policy Changes. Recently, the Centers for Medicaid and CHIP Services (CMCS) released a resource detailing the implementation of policy and technology requirements for final rules and statutes that could require changes to state Medicaid Enterprise Systems (MES). The “Roadmap of Select Medicaid and CHIP Policy Implementation Dates” allows users to see upcoming implementation dates for MES changes and filter by the type of system that requires updates (e.g., state websites, eligibility systems, or enrollment systems) as well as the governing statute or regulation. According to CMCS, the timeline is not intended to include all regulations or statutes that may impact Medicaid or CHIP programs. Instead, it focuses on rules and regulations that potentially impact systems, which CMS notes may look different in each state and territory.
Federal Judge Blocks Rule Defining Medical Frailty for Medicaid Community Engagement Requirements. Last Thursday, a US District Court Judge in Massachusetts blocked the Centers for Medicare & Medicaid Services’ (CMS) Interim Final Rule (IFR) defining medical frailty exemptions for the upcoming Medicaid community engagement requirements. 25 states and DC sued over the rule’s implementation, arguing that the definition was unlawful and that required enforcement could lead to otherwise eligible Medicaid beneficiaries being disenrolled. Furthermore, Judge Richard Stearns ruled that states would receive a 6-month stay on implementing any determinations of whether an individual qualifies as medically frail. However, Judge Stearns upheld the rule’s two other provisions requiring data used to verify medical frailty to be no older than twelve months and restricting self-attestations to once per enrollment period.
Indiana
Family and Social Services Administration Releases Approach for Medicaid Medical Frailty Exemptions. This past Tuesday, the Indiana Family and Social Services Administration (FSSA) announced its three-tiered approach for determining medical frailty exemptions for Medicaid community engagement requirements effective January 1, 2027. The first tier uses Milliman Advanced Risk Adjusters (MARA) to automatically review qualifying diagnoses and indicate whether a beneficiary falls under medical frailty. In addition to qualifying diagnoses, the second tier has MARA review treatments, services, procedure codes, devices, durable medical equipment, and pharmacy claims. The third tier allows beneficiaries, providers, managed care organizations, or state staff to submit referrals and additional medical documentation for beneficiaries that did not qualify under Tier 1 or 2. State clinical staff will review the documentation and make the final determination of medical frailty. FSSA estimates that over 139,000 beneficiaries will qualify through the automated screenings. Exemptions will last for six months, and FSSA expects to send initial notices out by late November or early December.
Family and Social Services Administration Temporarily Withdraws Medicaid Managed Care RFP. Last Tuesday, the Indiana Family and Social Services Administration (FSSA) announced it was withdrawing its request for proposals (RFP) for the state’s Medicaid managed care system. FSSA issued the RFP last August, and anticipates re-releasing the RFP by November 9 with minimal changes and to incorporate the State Budget Committee’s feedback. The reprocurement includes the state’s four managed care programs: Hoosier Healthwise (HHW), Healthy Indiana Plan (HIP), Hoosier Care Connect (HCC), and Indiana PathWays for Aging, which cover approximately 1.5 million beneficiaries. FSSA intends to award all four programs to the same awarded health plans; successful bidders must support care integration for Medicare-Medicaid dual enrollees throughout the contract term and operate a Dual Eligible Special Needs Plan (D-SNP) beginning January 1, 2029, under Indiana PathWays for Aging. FSSA seeks applicants that will support the Make Indiana Healthy Again Initiative, advance quality improvement, member engagement, provider collaboration, and fiscal accountability, and implement member and provider incentive programs, targeted enhanced benefits, and expanded value-based purchasing arrangements. The agency still expects that contracts will begin January 1, 2029.
Missouri
Attorney General Hanaway Sends Cease-and-Desist over 340B Covered Entity Claims Submissions. Last Monday, Attorney General Catherine Hanaway (R) sent a cease-and-desist letter to a drug manufacturer, ordering it to stop requiring covered entities to submit claims data to access 340B discounts. In particular, the letter orders the manufacturer to end its requirement that covered entities submit claims for dispensation of all drugs, regardless of setting, and to stop using the collected claims data. Attorney General Hanaway’s office stated that failure to comply may result in enforcement action under the Missouri Merchandising Practices Act. According to the office, the manufacturer updated its claims submission policy in January 2026, which the University of Missouri Health Care refused to comply with, leading the manufacturer to cut the hospital off from 340B pricing on July 2, 2026. The letter gives the manufacturer 30 days to confirm it ended its policy and stopped using the claims data.
North Carolina
Supreme Court Agrees to Hear Challenges on CON Awards. Recently, the North Carolina Supreme Court agreed to hear two challenges from a nonprofit health system on Certificates of Need (CON) the state previously awarded. In both cases, lower courts previously rejected the health system’s arguments, including a case regarding a CON for a freestanding emergency department in Candler, NC. In 2024, the Court of Appeals found that state regulators failed to follow proper procedures by not holding a public hearing before awarding the Candler CON, but that the error did not amount to substantial prejudice against the health system. The health system did not apply for the Candler CON; critically, it is asking the Supreme Court to define what a challenger must prove to win a dispute over a “noncompetitive” CON review. If the court rules for the health system, it could make it easier for competitors to challenge CON awards statewide.
Department of Health and Human Services Releases Strategic Plan for Medicaid and Rural Health. Recently, the North Carolina Department of Health and Human Services (NCDHHS) released its 2026-2030 Strategic Plan. The plan prioritizes coordinating implementation of Medicaid, the Supplemental Nutrition Assistance Program (SNAP), and other child support services; expanding rural health services through the Rural Health Transformation Program; improving behavioral health crisis care for individuals involved with the justice system; and creating partnerships to address healthcare affordability. Through these priorities, NCDHHS plans to support access to care, residents’ well-being, rural care delivery, the healthcare workforce, and health technology and data use.
Ohio
Court Blocks Provisions in Unconstitutional Six-Week Abortion Ban. Last Thursday, Hamilton County Common Pleas Court Judge Christian Jenkins struck down provisions of Ohio’s six-week abortion ban that required providers to test for fetal cardiac activity and ask patients why they are seeking abortions. The law has not been enforced since 2023, after voters approved a constitutional amendment guaranteeing individuals’ right to make their own reproductive decisions. Judge Jenkins reasoned that requirements of the now-void heartbeat law that carried potential criminal and civil penalties for providers were unconstitutional for inhibiting access to abortion in violation of the 2023 constitutional amendment. Attorney General Andy Wilson’s (R) office is currently reviewing the decision, though it has not yet indicated whether the state will pursue an appeal.
Oklahoma
Health Care Authority Receives Approval for Mental Health and Substance Use Disorder Waiver Renewal. This past Wednesday, the Centers for Medicare & Medicaid Services (CMS) approved a five-year renewal of Oklahoma’s Institutions for Mental Diseases Waiver for Serious Mental Illness/Substance Use Disorder Section 1115(a) Demonstration, extending the waiver through 2031. Through the renewal, the state can continue providing coverage for serious mental illness (SMI) and substance use disorder (SUD) treatment to short-term residents of institutions of mental diseases (IMDs). Additionally, the renewal eliminates the state’s authority to provide coverage through Qualified Residential Treatment Programs for beneficiaries under the age of 21; a program which the Health Care Authority never implemented.
Virginia
Court Sets Hearing on Challenge to Reproductive Rights Ballot Measure if Approved. Recently, the Tazewell Circuit Court ordered a court hearing for November 13 regarding a reproductive rights ballot measure, if it is approved by voters on November 3. The lawsuit seeks a preliminary injunction to block the amendment, alleging it was not properly filed and that the ballot language is misleading. If approved, the measure would establish a constitutional right to reproductive freedom, including abortion care, contraception, and fertility care. The plaintiffs argue that, along with the misleading language, the amendment would eliminate required parental consent for minors seeking surgical birth control procedures or abortions and risk patient safety by removing the current three-physician approval process for later-term abortions. Notably, the hearing is taking place in the same circuit court where a judge ruled to overturn Virginia’s approved ballot initiative for a mid-decade congressional redistricting.