Jason Schultz

2 months ago | natlawreview.com | Jason Schultz

Highlights HHS-OIG recently released Advisory Opinion No. 24-12, a favorable opinion involving a drug manufacturer’s patient support program for individuals who suffer from genetic condition causing chronic kidney stones The proposed arrangement is consistent with previous HHS-OIG guidance on patient assistance that promotes access to care involving rare health conditions The HHS-OIG noted several factors that limited the possibility of fraud and abuse, even though the arrangement implicates...

Jan 23, 2025 | natlawreview.com | Jason Schultz

Highlights A favorable opinion from HHS-OIG involves a drug manufacturer covering the costs of meningococcal vaccines for patients with increased risk of infections due to the manufacturer’s drug treatments The HHS-OIG found the proposed arrangement improved patient safety and access to treatment for several different rare disorders The proposed arrangement included several factors that limited risk under the CMP and Anti-Kickback Statutes The U.S. Department of Health and Human Services’...

Oct 21, 2024 | natlawreview.com | Jason Schultz

Skilled nursing facilities (SNFs) will receive notice of required off-cycle revalidation from their Medicare Administrative Contractor from October to December 2024 SNFs will have 90 days from the date of each letter to submit additional required information under the newly revised CMS-855A into the PECOS system or by paper application The additional reporting requirements require SNFs to disclose new information regarding their ownership and contractual relationships The Centers for Medicare...

Sep 6, 2024 | natlawreview.com | Jason Schultz

Highlights The HHS-OIG released a favorable opinion on a patient assistance program (PAP) run by a nonprofit that subsidizes Medicare Part D cost-sharing obligations for diabetes treatments The agency determined low risks for fraud and abuse as the PAP was not controlled or influenced by pharma, would not steer patients to a particular treatment or pharmacy, and would not lead to overutilization or increased costs to federal healthcare programs The opinion demonstrates the agency’s...

Aug 23, 2024 | natlawreview.com | Jason Schultz

Highlights The HHS-OIG issued an unfavorable opinion on whether a pharma manufacturer may offer financial assistance to patients if they have significant side effect from its gene therapy product The agency determined it did not have sufficient data to determine that the arrangement is sufficiently low risk to garner a favorable advisory opinion The opinion reiterates the HHS-OIG’s concern that financial need is not a sufficient basis for permitting valuable gifts that may constitute...