Healthcare

California continues to lead the way in regulating foods and dietary supplements sold within its borders. Two recent developments are worth highlighting: the nation's first statewide "Non-Ultraprocessed" food certification program, and a second-of-it...

The proposed class action lawsuit alleging claims for negligence, negligence per se, and breach of contract following a data breach will proceed. The federal district court in St. Louis, Missouri has held that a pharmaceutical company specializing in...

California consumer protection and warranty claims challenging the natural labeling of ginger ale containing industrially manufactured citric acid may proceed, despite federal regulatory guidance classifying fermentation-derived citric acid as nonsyn...

The contractor responsible for screening dentists’ requests for state Medicaid funding for children’s orthodontia, was neither a “governmental unit” nor an “individual” for the purposes of conferring interlocutory appeals jurisdiction. The Supreme Co...

The FDA issued a final rule to amend the standard of identity regulations that specify salt as a required or optional ingredient to permit the use of salt substitutes in standardized foods. The final rule amends the FDA’s standard of identity regulat...

The FDA has determined that LASIX (furosemide) oral solution, 10 milligrams (mg)/ milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that the FDA will not begin procedures to withdraw approva...

CMS lawfully revoked a physician’s Medicare enrollment and added him and his medical practice to the preclusion list based on an affiliation deemed to pose an undue risk of fraud, waste, or abuse. The Departmental Appeals Board (DAB) upheld CMS’ revo...

An HHS ALJ upheld the Inspector General’s exclusion of a former pharmacy technician from federal health care programs after a state licensing board revoked her license based on findings related to unlawful diversion and possession of controlled subst...

The providers denied the allegations that it intentionally used the wrong CPT codes to bill substantially higher “office visit” rates than the rates permitted for COVID-19 specimen collection. The Department of Justice (DOJ), acting on behalf of the ...

The HHS Office of Inspector General’s (OIG) Work Plan—the list of agency audits, evaluations, and inspections that are planned or underway—is adjusted throughout the year to meet changing agency priorities. The OIG has issued Work Plan updates for Se...

Law firms continue to strengthen health care, life sciences, FDA regulatory and litigation capabilities through strategic attorney additions in key U.S. markets. Arnall Golden Gregory. Arnall Golden Gregory welcomed David O. Ault as a partner in its ...

Earlier this month, FDA opened applications for a new Expedited Investigational New Drug (IND) Pilot Program (the "Program"), an initiative launched under HHS Operation TrialBlazer[1] that aims to shorten the path from IND-enabling activities to firs...

The insurer allegedly transmitted sensitive health information to third parties even after users restricted tracking through privacy controls on its website and patient portals. Humana must defend a proposed class action alleging that it secretly int...

The court affirmed dismissal for “impossibility” preemption; however, amendment was not certainly futile because the estate made a presentation of newly acquired information forming a basis for a label change. A state law complaint about the labeling...

The Drug Enforcement Administration (DEA) is revoking the exempted status for certain nonnarcotic prescription products that are currently on the DEA’s Table of Exempted Prescription Products. The certain nonnarcotic prescription products’ National D...

The FDA announced the availability of a draft guidance for industry titled “Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants.” The draft guidance states that...

The FDA has classified the hematopoietic cell enrichment kit into class II (special controls). The special controls that apply to the device type are identified in the order and will be part of the codified language for classification of the hematopo...

An ALJ upheld CMS’ determination that a supplier’s Medicare billing privileges were reactivated on the date CMS received an enrollment application that was later approved. The HHS Departmental Appeals Board (DAB) affirmed CMS’ determination that Octo...

CMS plans to allot up to another $40 billion of the remaining program funds to states over the next four years. In its report to HHS, the Government Accountability Office (GAO) described CMS’s administration of the Rural Health Transformation (RHT) p...

The complaint alleged that a reasonable consumer is likely to be misled by the candy manufacturer’s “naturally flavored” statement on its packaging. A federal district court in California denied a candy maker’s motion to dismiss various consumer prot...

In regard to the two synthetic 7-OH derivatives, MGM-15 and MGM-16, the DEA emphasized the commercial marketing of these substances as a significant public health concern. The Drug Enforcement Administration (DEA) recommended in two proposals additio...

The FDA announced the availability of a final guidance for industry entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers.” This guidance provides answers to commonly asked questions...

The FDA identified the risks to health associated with this type of device and the measures required to mitigate these risks. The FDA has classified the infant pulse rate and oxygen saturation monitor for over-the-counter use into class II (special c...

The FDA believes the action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens. The FDA has classified the system for detection of nucleic acid from non-viral microorganism(s) causing sexually ...

The DAB upheld a 23-year exclusion from federal health care programs, finding that substantial financial losses, prolonged fraudulent conduct, a lengthy prison sentence, and related state disciplinary actions justified the extended exclusion period. ...

The government alleged that the non-profit organization failed to timely investigate and delete diagnosis codes that were either inaccurate or not documented in medical records. Los Angeles-based AIDS Healthcare Foundation (AHF) d/b/a Positive Health...

The state agency’s lack of written policies and procedures for preparing CMS reports and reconciling the reported amounts led to the accounting errors. The HHS Office of Inspector General (OIG) audited records of the South Carolina Department of Heal...

The Department of Health and Human Services’ Office for Civil Rights (OCR) has reached a settlement with Shen Smiles P.C., a Pennsylvania-based dental practice, over potential violations of the Health Insurance Portability and Accountability Act (HIP...

A roundup of other items of interest to the Health Law community. LONG-TERM CARE FACILITIES—CMS LETTERS: REVISED: Nursing Home Risk-Based Survey National Implementation (CMS Letter , No. QSO-26-14-NH (Sept. 29, 2026)). MEDICAL DEVICES— S.D. W. Va.: P...

While the court dismissed the claims seeking damages, the health plan can proceed with seeking injunctive relief and amend the complaint. The federal district court in Chicago, Illinois has dismissed claims brought by a self-funded health plan for sh...

Although the product labels supported classwide reliance and materiality, the purchasers’ damages models were too preliminary to establish classwide damages. A hair care products manufacturer secured reversal of an order certifying a consumer class a...

Corrections made to address ANDA changes. The FDA corrected a notice that appeared in the Federal Register of September 13, 2023 (88 Fed. Reg. 62799). The notice announced the determination that oxandrin (oxandrolone) tablets, 2.5 milligrams (mg) and...

Removing these regulations will not change the IHS’s existing practices or authorities. The Indian Health Service (IHS) of the Department of Health and Human Services (HHS or “the Department”) is issuing this final rule to remove regulations appearin...

The purpose of excluding health care practitioners from participating in government health care programs is to protect the programs from fraud and abuse, exclusion is remedial, not punitive. A physician’s felony conviction for participation in a cons...

The ALJ upheld a determination that a skilled nursing facility violated Medicare quality-of-care requirements by failing to adequately monitor, assess, document, and respond to a resident’s significant change in condition, and upheld a $14,330 per-in...

Wisconsin disagreed with the OIG’s findings. The HHS Office of Inspector General (OIG) concluded that of the $505.5 million Medicaid reimbursement to Wisconsin’s School-Based Program, $454.9 million (89.9 percent) may have been improperly claimed. Br...

This Health Law Regulation Tracker includes a Proposed Rules Comment Calendar and a Table of Final Rule Effective Dates. New proposed rules. On October 8, 2026, CMS issued a proposed rule to amend the Clinical Laboratory Improvement Amendments of 198...

Action for privacy breach may proceed with respect to negligence claim but not breach of fiduciary duties, unjust enrichment, and declaratory judgment. A district court in Texas has granted in part and denied in part the motion to dismiss of a financ...

The patient was given another chance to pursue warranty claims under the UCC. A patient whose implanted hip nailing system failed could not recover against the manufacturer on breach of warranty theories because the nature of her allegation was based...

Existing CLIA certification regulations do not account for remote review of digital laboratory data, digital results, or digital images since these technologies were not available when the original regulations were codified. This proposed rule would ...

The OSC/ISO also proposed the revocation of Registrant’s DEA Certificate of Registration, alleging that Registrant’s continued registration is inconsistent with the public interest. On September 17, 2025, the Drug Enforcement Administration (DEA or G...

The applicant’s corporate structure, acting through the company that owns and controls it and its sister company, all of which are managed by the same CEO, engaged in the unregistered manufacture of marijuana for at least a decade and has diverted ma...

HHS will remove outdated language appearing in the CFR at 42 CFR 136.14(b), which stablished general principles and program requirements for carrying out Indian health programs. The Indian Health Service (IHS) of the HHS issued a final rule to remove...

There was no dispute that a physician participated in multiple proffer sessions in which he cooperated with investigators and prosecutors, but the ALJ did not err in finding that such cooperation did not rise to the level necessary to find a mitigati...

An HHS administrative law judge upheld immediate-jeopardy penalties after a skilled nursing facility failed to provide a high-risk resident with the gait belt and supervision required by her care plan, and the resident fell and fractured her wrist. A...

A new GAO report examines eight years of tobacco product applications, the timeliness of the review process, and what the agency has done to improve its review process. In a new report to Congress entitled, “Tobacco Products: FDA Should Monitor Timel...