CMS Final Rule – Accrediting Organization Oversight
The Centers for Medicare & Medicaid (CMS) has finalized a new rule strengthening oversight of Accrediting Organizations (AOs), the entities responsible for surveying and accrediting more than 9,000 Medicare-certified healthcare providers and suppliers. The rule is designed to ensure AO standards and survey processes align with Medicare requirements, promote consistency between accrediting organizations and State Survey Agencies, and enhance patient safety through more uniform enforcement of health and safety standards.
For hospitals, the rule introduces several important changes, including enhanced CMS monitoring of AO performance, standardized survey processes and definitions, and required CMS training for AO surveyors. Accreditation surveys must continue to be conducted without advance notice, and AOs will be prohibited from performing mock surveys for hospitals they accredit before an initial survey and within 12 months of reaccreditation to prevent conflicts of interest. To view the final rule, click here and to view the fact sheet, click here.
1115 Medicaid Waiver Budget Neutrality Guidance
The Centers for Medicare & Medicaid Services (CMS) has issued guidance on 1115 Medicaid waiver budget neutrality standards. H.R. 1, also known as the Working Families Tax Cuts (WFTC) or the One Big Beautiful Bill Act (OBBBA), statutorily added budget neutrality as a requirement for 1115 waiver demonstrations. This new guidance requires the Chief of Actuary of CMS to certify the demonstration is not expected to result in an increase in the amount of federal Medicaid expenditures compared to the amount that such expenditures would otherwise be in the absence of such project, effective Jan. 1, 2027 for approval of new applications, amendments, or renewals.
CMS is preparing a notice of proposed rulemaking to facilitate the Chief Actuary’s certification of budget neutrality, including changes to the analyses and documentation states would need to submit to CMS for review and determination of budget neutrality prospectively. As part of this rulemaking, CMS will propose a methodology for determining whether a demonstration project meets the requirements. To view the guidance, click here.
Governor Signs Bill Banning Sale of Intoxicating Hemp to Minors
On Friday, Gov. JB Pritzker signed Senate Bill 3222/PA 104-0463, legislation that bans the sale of intoxicating hemp to minors, while also seeking to bolster equity and oversight of the cannabis industry, according to a news release. The bill immediately bans the sale of intoxicating hemp products to people under the age of 21, and beginning in November 2026 intoxicating hemp products will be subject to regulations set forth in the Cannabis Regulation and Tax Act, including requiring child-proof packaging; banning misleading marketing and packaging that rips off consumer brands to appeal to children; and ensuring the existing cannabis regulatory framework applies to intoxicating hemp products. For more information, click here.
FDA Clears First OTC Continuous Glucose Monitor for Children
Last week, the Food and Drug Administration (FDA) cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM) for children, Dexcom Inc.’s Stelo Glucose Biosensor System, an integrated CGM indicated for people 2 years of age and older who do not use insulin. FDA previously cleared the device for individuals 18 years and older in March 2024. Prediabetes is increasingly impacting children in the United States, placing millions at heightened risk for progressing to Type 2 diabetes. OTC CGMs can play a critical role in addressing this public health concern for pediatric users who do not use insulin. By providing real-time glucose data, these devices can help pediatric patients and their caregivers build greater glycemic awareness, track patterns in response to meals and exercise, and make informed adjustments to support healthier long-term outcomes and quality of life.
