George Maliha M.D

Jul 3, 2024 | lexology.com | Meenakshi Datta |Catherine Y. Starks |George Maliha M.D

The Department of Health and Human Services Agency for Healthcare Research and Quality (AHRQ) published a Request for Information (RFI) on June 3, 2024, soliciting proposals for strategies and approaches to advance shareable, interoperable, and reusable clinical decision support (CDS) resources.

May 30, 2024 | lexology.com | Jaime Jones |Brenna Jenny |George Maliha M.D

DOJ recently secured dismissal of a qui tam complaint premised on alleged violations of EMTALA over the relator’s objections, with the district court affirming that DOJ satisfied the Polansky standard for Section 3730(c)(2)(A) dismissals by presenting a “reasonable argument.” In this case, DOJ’s argument rested on perceived flaws in the viability of the relator’s legal theory, government litigation costs, and complex privilege issues that would need to be resolved during discovery.

Apr 25, 2024 | lexology.com | Meenakshi Datta |Catherine Y. Starks |George Maliha M.D

The U.S. Centers for Medicare & Medicaid Services’ (CMS) annual Medicare Advantage and Part D final rule, published on April 23, 2024, will allow Medicare Part D Plans (PDPs) to change their biologics coverage policies in the middle of a plan year beginning in Calendar Year (CY) 2025 without a robust transition process for current branded biologic prescriptions.

Apr 9, 2024 | lexology.com | Jon Zucker |Jaime L.M. Jones |Francesca R. Ozinal |George Maliha M.D |Taylor Andelman

The U.S. Centers for Medicare and Medicaid Services (CMS) published a final rule on April 4, 2024 that overhauls the regulations governing insurance agent and broker compensation rates and agreements for Medicare Advantage Plans (MAPs) and Medicare Part D Plans (PDPs). The final rule, which adopts the majority of the changes from the proposed rule that we previously discussed here, is intended to establish additional guardrails to protect beneficiaries and support competition within the industry.

Dec 14, 2023 | lexology.com | Meenakshi Datta |Mark Langdon |Brenna Jenny |George Maliha M.D

Two recent developments serve as reminders that healthcare and life sciences companies should take care in structuring so-called “commercial only” arrangements that seek to reduce U.S. Anti-Kickback Statute (AKS) risk by excluding federal healthcare program (FHCP) patients from the arrangement.