Maggie Woods appointed NC Rural Health Director
NCDHHS announced Maggie Woods as the new Rural Health Transformation Program Director to lead North Carolina's $213 million federal initiative supporting rural healthcare delivery. The program will support over 400 rural health facilities across the state serving more than 3.5 million rural residents, addressing workforce shortages, hospital sustainability, and access gaps in mental health and primary care.
Health Talk MS Podcast Episode on Environmental Health Protection
The Mississippi State Department of Health released an April episode of the Health Talk MS podcast featuring Office of Environmental Health directors Les Herrington and Bill Moody discussing environmental health programs. Topics include food safety and restaurant inspections, on-site wastewater regulation, milk and bottled water regulation, and public water supply licensing and quality assurance.
National Public Health Week Celebration
The Mississippi State Department of Health (MSDH) announced the celebration of National Public Health Week from April 6-12. The agency will spotlight various health services through social media and its website, including perinatal services, adult health, vital records, WIC, communicable disease prevention, and the Mississippi Medical Cannabis Program. This is an informational observance recognizing public health professionals across government, business, and nonprofit sectors.
Public Data Asset Release Under OPEN Government Data Act
CMS announced the release of seven public data assets containing Original Medicare utilization and payment data aggregated by provider and service, including physician services, inpatient/outpatient hospitals, Part D prescribers, DMEPOS, and Medicaid provider spending. The datasets are released in open, machine-readable formats under an open license pursuant to the OPEN Government Data Act. CMS evaluated privacy protections under HIPAA, 21st Century Cures Act, and 42 CFR Part 2, determining the data has been de-identified and appropriately limited to mitigate re-identification risk.
CMS PRA Information Collection Request - Annual EPSDT Participation Report
The Centers for Medicare & Medicaid Services (CMS) published a Paperwork Reduction Act (PRA) notice inviting public comment on the revision of Form CMS-416, the Annual Early and Periodic Screening, Diagnostic and Treatment (EPSDT) Participation Report. The notice summarizes the proposed data collection to assess state effectiveness in providing child health screening and treatment services to Medicaid-eligible children. Comments must be submitted to the OMB desk officer by May 6, 2026.
PRA Notice - Skilled Nursing Facility Physician Certification Information Collection
CMS published a 60-day notice under the Paperwork Reduction Act requesting public comment on an information collection related to physician certifications and recertifications in skilled nursing facilities under Section 1814(a) of the Social Security Act. The notice includes burden estimates and invites comments on the necessity, utility, and accuracy of the proposed information collection. Comments must be received by June 5, 2026.
WISeR Model Prior Authorization Technical Correction
CMS issued a correction notice correcting typographical and technical errors in the July 1, 2025 Federal Register notice regarding the WISeR (Wasteful and Inappropriate Services Reduction) Model prior authorization requirements. The corrections refine the lists of Local Coverage Determination (LCD) codes for specific services including Epidural Steroid Injections, Vertebral Compression Fracture procedures, Fusion surgeries, and Sleep Apnea treatments. The corrections are effective April 6, 2026, with applicability to WISeR items and services implemented on January 1, 2026.
WISeR Prior Authorization Implementation Delay
CMS issued a notice delaying implementation of prior authorization requirements for two services under the Wasteful and Inappropriate Services Reduction (WISeR) model: Deep Brain Stimulation for Essential Tremor and Parkinson's Disease (NCD 160.24) and Percutaneous Image-Guided Lumbar Decompression for Spinal Stenosis (NCD 150.13). The original January 1, 2026 implementation date is postponed until a future date to be announced. This is a routine administrative delay to allow additional time for operational readiness.
Hospice Wage Index and Payment Update for FY2027
CMS has issued a proposed rule updating the hospice wage index, payment rates, and aggregate cap amount for Fiscal Year 2027. The proposed rule would require hospices to provide the hospice election statement addendum to all Medicare beneficiaries at the time of hospice election. Comments are due by June 1, 2026.
FY2027 IRF Prospective Payment Rate Updates and Policy Changes
CMS proposes updates to Inpatient Rehabilitation Facility (IRF) prospective payment rates for Federal fiscal year 2027, including the third year of rural adjustment phaseout. The proposed rule includes new requirements for therapy initiation timing (within 36 hours of admission), functional status documentation on preadmission screenings, and interdisciplinary team meeting requirements. Comments are due June 1, 2026.
Medicare Advantage and Part D Drug Benefit Changes
CMS issued a final rule effective June 1, 2026 (applicable to coverage beginning January 1, 2027) implementing Medicare Advantage (Part C), Medicare Part D, and Medicare cost plan changes. The rule codifies Inflation Reduction Act section 11201 changes to Part D benefit design, including new coverage phases, out-of-pocket thresholds, and the Manufacturer Discount Program replacing the Coverage Gap Discount Program.
All IPAY 2028 manufacturers agree to IRA negotiations
All IPAY 2028 manufacturers agree to IRA negotiations
Life Science Regulatory Update: AI IP, Biosimilar Approvals, Cell Therapy
FDA published new guidance in February-March 2026 allowing biosimilar applicants to use foreign clinical trial data to accelerate U.S. approval for rare and ultra-rare diseases. The agency also indicated increased flexibility for iterative manufacturing changes in cell and gene therapies, creating new IP strategy considerations. Knobbe Martens summarizes these regulatory developments for life science companies and their counsel.
EPA Draft CCL 6 Includes Microplastics and Pharmaceuticals for Drinking Water Regulation
The EPA announced the draft Sixth Contaminant Candidate List (CCL 6) under the Safe Drinking Water Act on April 2, 2026. For the first time, microplastics and pharmaceuticals have been designated as potential contaminants, alongside PFAS (as a class), disinfection byproducts, 75 chemicals, and 9 microbes. The draft is open for public comment until June 1, 2026. The CCL process identifies emerging contaminants for research but does not itself impose regulatory requirements.
Idaho Minor Consent Law Amendments
Idaho amended Idaho Code § 32-1015 governing minor consent for healthcare services, effective March 31, 2026 (H0860E1). The amendments maintain parental consent requirements for minors while creating new uncertainties regarding noncustodial parent rights and interaction with existing laws allowing minor self-consent for specific services including contraceptives, communicable disease treatment, and substance abuse care.
Texas HB 4224 - Patient Health Information Posting Requirements
Texas HB 4224 added Section 181.105 to the Texas Health and Safety Code, effective September 1, 2025. The law requires covered healthcare entities to prominently post on their websites and at physical facilities instructions covering three topics: how patients can request healthcare records, how to contact the licensing board, and how to file a consumer complaint. Entities performing only claims processing, billing, or data analysis backend functions are exempt.
Ninth Circuit Reverses FCA Case Against AbbVie for 340B Pricing Fraud
The Ninth Circuit reversed the district court in United States ex rel. Adventist Health System of West v. AbbVie Inc., holding that the False Claims Act provides an independent mechanism for relators to pursue claims alleging fraudulent drug pricing in violation of the 340B Program, even though Section 340B itself contains no private right of action. The court rejected manufacturers' arguments that FCA claims require a prior HRSA violation. The ruling exposes pharmaceutical manufacturers to significant FCA liability for 340B pricing practices.
FDA Updates Patient Preference Information Guidance for Medical Devices
FDA's Center for Devices and Radiological Health and Center for Biologics Evaluation and Research issued final guidance on Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle, superseding the August 2016 guidance. The 2026 guidance clarifies scope across the device lifecycle and substantially enhances methodological specificity for PPI studies. The guidance now expressly recognizes PPI relevance to 510(k) submissions and postmarket enforcement decisions.
Colorado Conversion Therapy Ban Unconstitutional - First Amendment
The Supreme Court ruled 8-1 in Chiles v. Salazar that Colorado's 2019 law prohibiting licensed mental health counselors from performing conversion therapy on minors is unconstitutional. The Court held the statute violated a counselor's First Amendment rights by directly regulating the content and viewpoint of speech during counseling sessions. Colorado's argument that the law regulated professional conduct with only incidental speech effects was rejected.
Proposed Amendments to Runaway and Homeless Youth Program Regulations
HHS/ACF published a Notice of Proposed Rulemaking to remove duplicative or unnecessary sections from 45 CFR part 1351 governing the Runaway and Homeless Youth Program. The amendments aim to streamline program regulations, reduce administrative burden on grantees, and make requirements more accessible. Public comment period closes May 6, 2026.
TANF Work Participation Rate Calculation Changes Under the Fiscal Responsibility Act
ACF proposes amendments to TANF regulations implementing statutory changes from the Fiscal Responsibility Act of 2023. The rule resets the base year for the caseload reduction credit from FY 2005 to FY 2015 and excludes cases receiving less than $35 monthly in assistance from work participation rate calculations. States must submit comments by May 6, 2026.
Proposed Streamlining of Family Violence Prevention and Services Regulations
HHS ACF proposes to remove duplicative or unnecessary sections from 45 CFR part 1370, the Family Violence Prevention and Services program regulations. The NPRM would rescind two regulatory sections affecting States, Territories, Tribes, and nongovernmental entities that administer family violence prevention grants. Public comments are due May 6, 2026.
Rural Health Center of Excellence RFP
Montana DPHHS announced it is accepting proposals for two components of the Rural Health Center of Excellence (CoE): one to create and operate the CoE, and another to assist rural facilities in implementing CoE recommendations. The CoE is part of the Rural Health Transformation Program funded by a $233 million first-year CMS award, with up to $1.2 billion available over five years.
Strengthening Families Month Child Abuse Prevention Awareness
The Montana Department of Public Health and Human Services (DPHHS) announced the kickoff of Strengthening Families Month in April 2026, a statewide child abuse prevention awareness initiative. The Montana Children's Trust Fund will distribute over 12,000 blue pinwheels statewide, with over 71 organizations planning events including pinwheel plantings, family carnivals, and educational workshops. A kickoff event is scheduled for April 3 at Shodair Children's Hospital in Helena.
Governor Gianforte SNAP Junk Food Restriction Waiver Submission
Montana Governor Greg Gianforte submitted a waiver request to USDA Secretary Brooke Rollins to restrict SNAP purchases to nutritious foods, limiting purchases of soft drinks, candy, and junk food. The proposed demonstration project targets approximately 20 percent of SNAP spending currently used on unhealthy items and aligns Montana with 22 other states. The waiver introduces restrictions on beverages exceeding 10 grams of sugar per 8 ounces and establishes a standardized definition for candy and prepared desserts.
Montana Extends Pediatric RSV Immunization Through April
The Montana Department of Public Health and Human Services (DPHHS) issued a notice on March 18, 2026, recommending that healthcare providers continue offering RSV immunizations to eligible infants and young children through April 30, 2026. This extension addresses RSV activity that began circulating later than usual and continues to rise across Montana and the nation. The notice aligns with CDC recommendations for the groups most at risk, including infants under 8 months not yet immunized this season and high-risk children ages 8-19 months.
Montana Medicaid Community Engagement Resource Website Launch
DPHHS launched a new website at medicaidchanges.mt.gov to help Montana Medicaid Expansion members understand upcoming community engagement requirements effective July 1, 2026. Under H.R. 1 (enacted July 4, 2025), non-exempt adults aged 19-64 must complete 80 hours of qualifying activities per month to maintain coverage. DPHHS is conducting outreach via mail to affected members.
North Regional Call Health Coordination Meeting
The Indiana Department of Health announced the North Regional Call health coordination meeting scheduled for April 22, 2026, from 10:00am to 11:00am EDT. The virtual meeting will host IDOH subject matter experts, Local Health Department (LHD) programs, success stories, and updates from the northern regional team.
South Regional Call Health Meeting
The Indiana Department of Health announced a South Regional Call health meeting scheduled for Thursday, April 23, 2026, from 11:00am to 12:00pm EDT. The virtual meeting will be hosted on Microsoft Teams and appears to be an internal coordination call for regional health department staff and program administrators.
Statewide Child Fatality Review Committee Meeting Notice
The Indiana Department of Health published a public meeting notice on March 31, 2026 for the Statewide Child Fatality Review Committee meeting scheduled for April 10, 2026. The meeting will be held from 9 a.m. to noon EST at the Robert O. Yoho Board Room in Indianapolis, with a public session followed by a closed session for case review to protect privacy.
Rural Health Transformation Program Updates Webinar
The Indiana Department of Health announced a statewide webinar on April 2, 2026 to provide updates on the Rural Health Transformation Program. Indiana was awarded nearly $207 million for Year 1 of this five-year federal initiative aimed at improving healthcare access, quality, and outcomes for Hoosiers in rural areas of the state.
Central Regional Call
Indiana Department of Health announces a virtual Central Regional Call meeting scheduled for April 24, 2026 from 10:00am to 11:00am EDT. The meeting will be conducted via Microsoft Teams with dial-in options available for participants. This is an internal coordination meeting for local health department program staff.
Generic Omeprazole Oral Paste Approved for Horse Gastric Ulcers
The FDA approved Gastrobim (omeprazole) oral paste as a generic equivalent to Gastrogard for the treatment and prevention of gastric ulcers in horses and foals four weeks of age and older. Sponsored by Bimeda Animal Health Ltd. of Ireland, the drug was determined bioequivalent to the brand-name product approved in 1999. Gastrobim is available only by prescription from a licensed veterinarian.
Maria Anzures-Camarena Permanent Debarment - FDA Drug Applications
FDA issued a permanent debarment order for Maria Anzures-Camarena, prohibiting her from submitting or assisting in the preparation of drug applications to the agency. The debarment stems from her felony conviction related to drug application matters. All FDA-regulated drug product applications submitted by or on behalf of Ms. Anzures-Camarena are permanently barred.
Permanent Debarment Order - Miguel Angel Montalvo Villa
The FDA issued a Final Debarment Order permanently excluding Miguel Angel Montalvo Villa from submitting or providing assistance in the preparation of drug applications under section 306(a) or (b) of the FD&C Act. The debarment follows a conviction under federal law related to drug product approval. This action prohibits Montalvo Villa from any role in drug application submissions to FDA.
FDA Permanent Debarment Order - John Warrington Kosolcharoen
FDA issued a final permanent debarment order against John Warrington Kosolcharoen, barring him from participating in any way in the submission of applications for FDA approval or accreditation. The debarment relates to activities concerning FDA-regulated products, specifically applications under the Federal Food, Drug, and Cosmetic Act.
Bernardo Garmendia Permanent Debarment Order
The FDA issued a permanent debarment order against Bernardo Garmendia, preventing him from providing services in any capacity related to drug marketing or distribution under the FD&C Act. The order, effective March 14, 2025, follows Garmendia's felony conviction for a drug-related offense, denying his request for a hearing. Pharmaceutical companies and clinical investigators must ensure no engagement with debarred parties.
Matthew Teltser Permanent Debarment Order
The FDA issued a final order permanently debarring Matthew Teltser from providing services to any person or entity that has an approved or pending drug application. The debarment prohibits Teltser from directly or indirectly participating in any FDA-regulated drug business activities. This enforcement action (Docket No. FDA-2025-N-1956) took effect on February 6, 2026.
WHO World Health Day Campaign: Global Commitment to Science
WHO released its World Health Day 2026 campaign theme "Together for health. Stand with science." The campaign calls on people globally to renew commitment to science and international collaboration as drivers of health progress. The announcement highlights achievements including a 40% reduction in maternal mortality since 2000 and over 154 million children's lives saved through immunization over 50 years.
WHO head emergencies visit Lebanon reaffirms support to health system
WHO's Health Emergencies Programme Director Dr. Chikwe Ihekweazu completed a three-day visit to Lebanon reaffirming WHO's support for the national health emergency response amid escalating conflict pressures. WHO launched a $30 million Flash Appeal, with $10 million allocated for Lebanon, to address urgent health needs across five affected countries. Since March 2, 2026, 92 attacks on healthcare have been reported, resulting in 137 injuries and 53 deaths.
Alepsal Unavailable - Therapeutic Alternatives Identified
ANSM announces temporary unavailability of Alepsal (phenobarbital/caffeine anti-epileptic medication) due to supply disruptions affecting all dosages. Manufacturer Teofarma reports difficulties linked to a raw material supplier change, with normal supply expected by summer 2026. Three caffeine-free alternatives have been identified in coordination with the French neurology professional society: Gardenal 10mg and 100mg, and Phenobarbital Richard 100mg.