CDC Issues Health Advisory for Prescription Stimulant Users
Last week, the Centers for Disease Control and Prevention (“CDC”) issued a Health Advisory to inform public health officials, clinicians, and patients who use subscription-based telehealth platforms to obtain prescriptions for stimulant medications about possible disrupted access to medication and increased risks for injury and overdose. This disruption comes on top of an already ongoing prescription drug shortage involving several stimulant medications commonly prescribed to treat ADHD. As many as 50,000 patients could be impacted by this disruption.

New FAQs for Hospital Price Transparency Requirements
On July 1, 2024, new Hospital Price Transparency Requirements are set to take effect. To assist in understanding and meeting the new compliance requirements, the Centers for Medicare & Medicaid Services (“CMS”) updated its Frequently Asked Questions page with new information for both hospitals and patients. 

OIG Issues Favorable Advisory Opinion for Pharmaceutical Manufacturer’s Financial Assistance for Patients
The Office of Inspector General for the Department of Health and Human Resources (“OIG”) issued a new advisory opinion, Advisory Opinion No. 24-03. Requestor is a pharmaceutical manufacturer of a gene therapy product (“Product”) recently approved by the U.S. Food and Drug Administration (“FDA”) as a one-time, potentially curative treatment for two conditions. The Product will be administered in multiple treatment stages at one of at least 50 Treatment Centers Requestors plans to activate.  In the Proposed Arrangement, Requestor will offer one patient and one caregiver for patients ages 26 years and older, or one patient and two caregivers for patients under 26 years of age, assistance for certain travel, lodging, meals, and associated expenses during specific stages of treatment. Only patients who meet certain criteria, including being at or below 600% of the Federal poverty level, will be offered assistance. The Proposed Arrangement will be implemented and administered by Requestor and a travel vendor, will not be available when insurance or Treatment Center support is available, and will not be advertised beyond providing providers with a general overview of the patient support resources available for qualifying patients. The OIG indicated that although the Proposed Arrangement would generate prohibited remuneration under the Federal anti-kickback statute if the requisite intent were present, it would not impose administrative sanctions; and the Proposed Arrangement does not constitute grounds for the imposition of sanctions under the Beneficiary Inducements CMP.

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