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The Rhode Island General Assembly has passed legislation to allow the state to join an interstate dietitian licensure compact. This initiative aims to streamline the licensing process for dietitians, enabling them to practice in multiple compact states without obtaining separate licenses for each jurisdiction. The bill now awaits action from the governor.
The Alabama Board of Medical Examiners (ALBME) emphasizes that despite federal flexibilities, state laws ultimately govern telehealth prescribing of controlled substances, requiring practitioners to adhere to Alabama's specific regulations. The Board's CME course on Prescribing and Pharmacology of Controlled Substances is designed to ensure healthcare professionals are compliant with these stringent state and federal requirements.
The Food and Drug Administration (FDA) has announced the availability of its final guidance document, "Evaluation of Therapeutic Equivalence." This guidance explains FDA's approach to therapeutic equivalence evaluations and codes, which are crucial for drug product selection and healthcare cost containment. These evaluations are listed in the FDA's "Orange Book" and serve as advice for state health agencies, prescribers, and pharmacists.
The Drug Enforcement Administration (DEA) has issued a temporary order placing O-desmethyltramadol (O-DSMT), including its isomers, esters, ethers, and salts, into Schedule I of the Controlled Substances Act (CSA). This action, effective from August 12, 2026, to August 12, 2028, is based on a finding that O-DSMT poses an imminent hazard to public safety. The order imposes stringent regulatory controls and sanctions applicable to all Schedule I controlled substances.
The FDA's Office of Women's Health and Center for Drug Evaluation and Research are hosting a public workshop on September 17, 2026, to examine current scientific evidence and knowledge gaps regarding testosterone use in menopausal women. The goal is to inform future research and potential drug development for testosterone products in this population. Healthcare professionals, industry, and patients are encouraged to attend and submit comments.
The former owner of a Montgomery County, Pennsylvania, home care agency has been sentenced to prison for her involvement in a $1.76 million Medicaid fraud scheme. The scheme involved approving kickback arrangements, assigning fraudulent caregivers, and billing for services not rendered between 2020 and 2023.
The Federal Trade Commission (FTC), joined by the State of Utah and Los Angeles County, has filed a lawsuit against telehealth provider Hims & Hers Health. The complaint alleges that the company engaged in deceptive privacy promises, utilized unlawful billing and subscription practices, and shared sensitive health information with advertising platforms through tracking technologies.
The FDA has announced the availability of new draft guidance titled 'Potency Assessment of Active Immunotherapy Products.' This document provides recommendations for developing and evaluating assays to ensure the potency of active immunotherapy products (ACTIMPs). It aims to clarify the FDA's current thinking on potency testing, including for peptide- and protein-based ACTIMPs, complementing existing guidance for cellular and gene therapies.
The Federal Trade Commission (FTC) has commenced an antitrust inquiry into Epic Systems Corp., the leading vendor of electronic health records, focusing on potential anticompetitive practices. Investigators are examining the company's employee non-compete agreements and its policies regarding rival technology companies' access to patient data.
The Medical Board of California provides definitive guidance on the permissible scope of practice and required supervision for Medical Assistants within the state. This guidance emphasizes that Medical Assistants are unlicensed individuals who perform non-invasive technical support services under direct supervision.
CMS is implementing a mandatory billing change for Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs) concerning distant-site non-behavioral telehealth, effective October 1, 2026. Concurrently, CMS has introduced the ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) Model, a 10-year voluntary program testing outcome-aligned payments for technology-supported chronic care services.
The Department of Justice (DOJ) has launched a new National Fraud Enforcement Division, significantly increasing resources dedicated to combating fraud across several sectors. This division has outlined its enforcement priorities, placing a sharpened focus on the healthcare industry, including telemedicine, Medicare/Medicaid billing, and controlled substance diversion.
The Department of Justice has created the National Fraud Enforcement Division (NFED), centralizing and expanding its capabilities to combat healthcare fraud across the nation. This new division significantly bolsters enforcement resources and will use advanced data analytics to target fraud, waste, and abuse in federal healthcare programs. Telemedicine, Medicare/Medicaid billing, and controlled substance diversion are key priorities, with potential for both civil and criminal liability.
The Centers for Medicare & Medicaid Services (CMS) has issued a final rule prohibiting the use of federal Medicaid funds for 'sex-rejecting procedures' for individuals under 18 years old, and federal CHIP funds for individuals under 19 years old. This rule also mandates that state Medicaid and CHIP plans must prohibit payment for these procedures for the respective age groups. A limited transition period of up to six months is provided for beneficiaries actively receiving cross-sex hormone therapy.
The National Cancer Institute (NCI), under the Department of Health and Human Services (HHS), has issued a notice seeking research co-development partners and/or licensees for a collection of human anti-CE1 antibodies. These antibodies, B9 and B10, target a beneficial viral peptide and have shown potential as therapeutics for hepatocellular carcinoma (HCC), the most common form of liver cancer. This pre-clinical stage invention offers a new avenue for treating this aggressive malignancy.
