News

CMS Launches Cell and Gene Therapy Model for Sickle Cell

• The Centers for Medicare and Medicaid Services (CMS) has reached agreements with Vertex Pharmaceuticals and Bluebird Bio to include newly approved treatments, Casgevy and Lyfgenia, in a new model aimed at improving access to cell and gene therapies for Medicaid patients. These therapies, which treat sickle cell disease, are a breakthrough for a condition that affects 100,000 people in the U.S., predominantly in the Black and Hispanic communities. The model, designed to help manage the high cost of these therapies, allows states to tie payments to patient outcomes, making it easier for Medicaid to cover treatments without breaking the budget. States can start applying to participate this month, with an optional funding application due by the end of February 2025. With the new model, CMS hopes to improve both access and affordability for Medicaid patients, who often face barriers to cutting edge treatment (Fierce Healthcare, December 4).

Federal Legislation

Congressional Budget Office Scores Bipartisan Safe Step Act Aimed at Increasing Prescription Drug Access

• The Congressional Budget Office (CBO) has released its score for the Safe Step Act, estimating that the legislation would likely increase premiums and reduce federal revenue by $2B over ten years. The Safe Step Act is a bipartisan, bicameral bill that would require employer plans to create a clear exceptions process for medication step therapy and increase access to prescription drugs. The National Psoriasis Foundation has been leading efforts to curtail step therapy and maintains that the bill would be cost neutral, citing similar policies in states and Medicare that have not impacted premiums. The legislation was first introduced in the 116^th Congress and has changed over time. It was included in the bipartisan Pharmacy Benefit Manager Reform Act that passed the Senate health committee in Spring 2023 and received a favorable report from the CBO that indicates cost savings. However, despite considerable stakeholder support, it does not appear that Democratic offers in Congress mention the Safe Step Act by name during this lame duck session (Inside Health Policy, December 6).

Federal Regulation and Guidance

CMS Releases State Medicaid Director Letter on Beneficiary Protections from Impermissible Sanctions and Penalties

• CMS released a State Medicaid Director Letter (SMD #24-005) on December 5, 2024. Building upon guidance from October 2022, the agency provided information to states on ensuring Medicaid beneficiary protections from impermissible sanctions and penalties related to eligibility fraud, waste, and abuse. CMS stated that it expects states to immediately cease any unallowable sanctions or penalties like administrative recoupments, early termination of eligibility, and lockouts. States that continue these actions may be subject to compliance actions like the withholding of federal financial participation. The agency emphasized that it is available for technical assistance in determining whether additional sanctions are permissible and reiterated that beneficiaries must be afforded due process during an investigation of suspected Medicaid beneficiary fraud (CMS, December 5).

HHS Sets Deadline for Providers to Meet Language Access Requirements

• Hospitals, clinics, and other providers subject to Section 1557 of the Affordable Care Act must comply with the new federal requirement for language access by July 5, 2025, according to a letter issued by the Department of Health and Human Services (HHS) Office of Civil Rights (OCR). The letter also directs providers using artificial intelligence to translate communications into other languages to have qualified interpreters review the translations for accuracy in cases critical to patient rights or safety. OCR stated that while machine translation may be a low-risk situation, providers must inform patients that the translations might contain errors. The letter follows continued concerns about compliance with Section 1557’s nondiscrimination rules, finalized in April, which require federally funded providers to ensure patients with limited English proficiency or disabilities, can access free language assistance. OCR Director Melanie Fontes Rainer emphasized the importance of these services, stating, “Healthcare is a right – and providing language assistance is a critical component to help ensure equitable outcomes and quality care for every person.” The requirements also call for cultural competency, accounting for differences in dialects and expressions, and ensuring that patients with disabilities receive communications in accessible formats such as Braille, large print, and sign language interpretation at no cost (Inside Health Policy, December 10).

CMS Releases New CMCS Information Bulletin  and Framework to Address Health-Related Social Needs

• CMS released an updated CMCS Information Bulletin (CIB) on December 10, which discusses opportunities that states have under Medicaid and CHIP to cover clinically appropriate and evidence-based services and supports to address health-related social needs. This new guidance clarifies, updates, and supersedes the CIB and Health-Related Social Needs (HRSN) Framework released in November 2023. A new HRSN Framework table is included in the December 10 CIB. CMS covers housing, intervention services, and nutrition services and indicates what is allowed through the various authorities available to states. The agency encouraged states to help enrollees maintain coverage and access to healthcare services by addressing HRSN (CMS, December 10).

CMS Releases Accompanying Slide Deck for Ex Parte Renewal Basic Requirements

• On December 5, CMS released a slide deck highlighting the basic requirements for states to follow regarding ex parte renewals of Medicaid and CHIP eligibility. The slide deck accompanies the CMCS Information Bulletin (CIB) brief that was released on November 26. The deck serves as a resource to remind states of the current requirements and expectations for renewal of eligibility to ensure that they are properly complying with federal standards (42 C.F.R. §§ 435.916 and 457.343), special considerations, and resources available to them. The CIB also includes actionable strategies that states can leverage to increase efficiency and effectiveness of the ex-parte system, including obtaining SSNs for non-applicant household members that are applying for their children’s coverage to verify household income, relying on findings from express lane agencies for eligibility, and continued usage of previously proven effective unwinding strategies (CMS, December 5; CMCS, November 26).

Key Findings From the 2021 Medicaid Maternal Health Equity Report: Disparities and Progress

• On December 5, 2024, CMS released the 2021 Medicaid Maternal Health Equity Brief slide deck, which highlights the critical role that Medicaid and CHIP play in addressing maternal health disparities, particularly among Black, Hispanic, and Indigenous populations. These populations experience significantly higher risks of pregnancy-related complications, with Black women being three times more likely to experience pregnancy-related complications compared to White women. Since Medicaid and CHIP cover nearly half of all births in the U.S., they have an opportunity to reduce these disparities. One of the key takeaways from the brief is the importance of expanding access to services that go beyond traditional medical care. The brief notes that integrating doula services is an area Medicaid has begun to expand in several states. The report also stresses the need for Medicaid to address social determinants of health. This includes services like transportation, housing, and food assistance that can significantly impact maternal health. Furthermore, there is an emphasis on combating implicit bias in healthcare settings and promoting culturally competent care to foster better communication and trust, especially with marginalized communities. Despite these efforts, there are still barriers to improving maternal health outcomes especially in rural areas and low-income populations. The brief recommends expanding Medicaid’s coverage to include a wider variety of maternal health services and ensuring that care is accessible, affordable, and tailored to meet the needs of all mothers (Medicaid.gov, December 5).

Federal Studies and Reports

Gallup Poll Shows that Most U.S. Adults are Dissatisfied with Healthcare Costs

• On December 6, Gallup released a Health and Healthcare poll, consisting of telephone interviews with a random sample of adults across the nation. The poll found that regardless of political affiliation, the majority of Americans are unhappy about the cost of healthcare, with only 15% of Republicans or Republican leaning, 19% of Democrats, and 19% of adults overall, having satisfaction toward the cost of healthcare. The poll also showed that in terms of healthcare quality, 33% rated it as good and 11% as excellent. Poll respondents also indicated that the most urgent health problems facing Americans are cost, access, and obesity. The Peterson-KFF Health System Tracker shows that since 2022, healthcare costs have increased by 119.2% and are expected to rise by 8% in 2025, based on a PwC annual report. Additionally, the CMS Office of the Actuary estimates that healthcare spending will increase by about 5.6% per year, rising to $7.7T by 2032 (Modern Healthcare, December 6).