High
HHS
Other
Legal action highlights growing regulatory scrutiny of telehealth companies' data practices and consumer protection compliance. The Federal Trade Commission, joined by attorneys general from Utah and California, has filed a lawsuit against telehealth provider Hims & Hers, alleging the company...
High
CMS
The health plans allege CMS' methodology unfairly penalizes MA plans, potentially affecting reimbursement and plan competitiveness in the 2026 star ratings cycle. SCAN Health Plan and Alignment Healthcare have filed a lawsuit against the Centers for Medicare & Medicaid Services (CMS) alongside...
High
HHS
Despite reports of delays, HHS confirms it is proceeding with a final rule that would bar providers offering pediatric gender-affirming care from receiving Medicare and Medicaid reimbursement. HHS rebuked a recent report claiming that a controversial proposal to add pediatric gender-affirming...
High
HHS
The HHS Office for Civil Rights investigation found OSF Healthcare disclosed protected health information without authorization during a media interview. OSF Healthcare System and its Affiliated Covered Entities have agreed to pay $552,250 to settle an investigation by the HHS Office for Civil...
High
Other
The Agency for Healthcare Research and Quality has spent less than 5% of its appropriated budget on grants and issued none in over a year, severely impairing its patient safety research mission. Congress appropriated $345 million for the Agency for Healthcare Research and Quality (AHRQ) for...
High
HHS
HHS is assembling technical experts to inform federal policy on clinical artificial intelligence standards, signaling increased regulatory focus on AI in healthcare delivery. The U.S.
High
CMS
💬 Comments close in 50 days (Sep 21)
Proposed rule would revise indirect hold harmless thresholds for state health care-related taxes under the One Big Beautiful Bill Act, with changes effective October 2026 and further phase-downs in 2027. The Centers for Medicare & Medicaid Services (CMS) has issued a proposed rule to implement...
High
CMS
💬 Comments close in 22 days (Aug 24)
Updates include base rate adjustments, acute kidney injury payment changes, and refinements to quality reporting measures that could affect dialysis providers' revenue strategies and HIT interoperability needs. The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule on June 26,...
Notable
FDA
FDA sets fee schedule for medical device submissions, establishment registrations, and periodic reports under MDUFA V for fiscal year 2027. The Food and Drug Administration has published the medical device user fee rates for fiscal year 2027, covering the period October 1, 2026 through September...
Notable
CMS
Annual updates add and remove specific HCPCS codes from lists requiring physician face-to-face encounters, written orders, and prior authorization for Medicare coverage. The Centers for Medicare & Medicaid Services (CMS) has issued updates to three key Medicare requirement lists affecting durable...
Notable
HHS
💬 Comments close in 57 days (Sep 28)
AHRQ requests OMB approval to continue collecting CAHPS survey data from health plans, proposing modifications to the existing information collection for quality measurement. The Agency for Healthcare Research and Quality (AHRQ) has announced its intention to request Office of Management and...
Notable
CMS
CMS's proposed Medicare reimbursement changes for 340B drugs would reduce safety-net hospital revenues while increasing for-profit hospital revenues, according to KFF analysis. CMS has proposed cutting Medicare reimbursement for drugs purchased through the 340B Drug Pricing Program while...
Notable
CMS
HHS
💬 Comments close in 26 days (Aug 28)
CMS and state entities will use Office of Personnel Management data to verify ACA exchange eligibility and affordability program qualifications. The Centers for Medicare & Medicaid Services (CMS) has announced the re-establishment of a matching program with the Office of Personnel Management...
Notable
CMS
The renewal allows NCQA to continue certifying Medicare Advantage plans through accreditation, avoiding duplicative CMS reviews. The Centers for Medicare & Medicaid Services (CMS) has approved the renewal of the National Committee for Quality Assurance's (NCQA) deeming authority for Medicare...
Notable
FDA
💬 Comments close in 44 days (Sep 15)
FDA seeks public comment on its infant formula information collection, including electronic Form FDA 3978, labeling, and recordkeeping requirements under the Paperwork Reduction Act. The Food and Drug Administration (FDA) has issued a Federal Register notice announcing a 60-day public comment...
Notable
CMS
💬 Comments close in 43 days (Sep 14)
CMS Request for Information on Clinical Laboratory Improvement Amendments (CLIA) aims to gather feedback on updating regulations to reflect advances in lab technology, cybersecurity, and emergency preparedness. The Centers for Medicare & Medicaid Services (CMS) has issued a Request for...
Notable
FDA
💬 Comments close in 11 days (Aug 13)
HHS requests stakeholder feedback on training and care delivery models for potential FDA-approved psychedelic drugs in ambulatory settings to support safe administration. On April 18, 2026, President Trump issued Executive Order 14401, "Accelerating Medical Treatments for Serious Mental Illness,"...
Notable
FDA
💬 Comments close in 40 days (Sep 11)
FDA proposes to allow distributed manufacturers to register as a single establishment and align foreign establishment requirements with the PREVENT Pandemics Act. The FDA issued a proposed rule to amend drug establishment registration and drug listing requirements for two specific scenarios:...
Notable
CMS
HHS
💬 Comments close in 4 days (Aug 6)
The program allows CMS to share data with the VA to confirm enrollment in Veterans Health Administration care, helping determine eligibility for insurance affordability programs under the ACA. The Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) has...
Notable
HHS
💬 Comments close in 22 days (Aug 24)
HHS is requesting public comment on potential updates to fraud-and-abuse protections that could affect how sponsors compensate trial participants, with implications for study design and compliance. The U.S.