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Dec 17, 2024 | 
today.westlaw.com | Jaime Jones |Meenakshi Datta |Brenna Jenny |Jon Zucker
(January 16, 2025) - Sidley Austin partners Jaime Jones, Meenakshi Datta, Brenna Jenny and Jon Zucker discuss a rare Special Fraud Alert from the Department of Health and Human Services, Office of Inspector General cautioning against paying for referrals of Medicare Advantage beneficiaries.
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Nov 5, 2024 | 
today.westlaw.com | Meenakshi Datta |Meghan M. Weinberg |Stephen Komorek
(November 25, 2024) - Meenakshi Datta, Meghan Weinberg and Stephen Komorek with Sidley Austin LLP discuss legislators' concerns about the potential for fraud stemming from agreements between telemedicine companies and pharmaceutical manufacturers.
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Sep 17, 2024 | 
lexology.com | Meenakshi Datta |Elizabeth Hardcastle |Mark Langdon |Catherine Y. Starks |Trevor L. Wear |Steve Komorek | +1 more
Beginning in January 2025, Medicare Part D prescription drug plans, including stand-alone and Medicare Advantage Part D Plans, must provide enrollees with the option to smooth their out-of-pocket (OOP) prescription drug costs (capped at $2,000 in CY2025) evenly throughout the plan year.
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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.
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Jul 2, 2024 | 
lexology.com | Meenakshi Datta |Brenna Jenny |Kwaku Akowuah |Jillian Stonecipher |Matt Bergs
U.S. Supreme Court Overrules Chevron, Creating New Opportunities in the Healthcare Industry On June 28, 2024, the Supreme Court issued its decision in Loper Bright v. Raimondo and Relentless v. Department of Commerce. As expected following oral argument, the Court overruled Chevron v. Natural Resources Defense Counsel, Inc. in a 6–3 decision written by Chief Justice John Roberts.
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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.
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Feb 27, 2024 | 
lexology.com | Sharon Flanagan |Stephen Abreu |Robert Darwin |Carlton Fleming |Frank Rahmani |Meenakshi Datta | +3 more
Our lawyers share the top investment and regulatory trends from last month’s agenda-setting JP Morgan Health Care Conference. We expect an abundance of novel financing structures, investment focus on new disease states, and important new U.S. Food and Drug Administration (FDA) guidance. Regulatory developments in the U.S.: The FDA has issued several new policy documents on issues such as clinical trial design and conduct, affirming the agency’s high bar for approvals.
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Jan 8, 2024 | 
lexology.com | Meenakshi Datta |Brenna Jenny |Donielle McCutcheon |Catherine Y. Starks |Kwaku Akowuah |Matthew Guillod
In late December 2023, the U.S. District Court for the District of Columbia issued an order that has important implications for pharmaceutical manufacturers that offer co-pay assistance for eligible patients.
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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.
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Nov 21, 2023 | 
lexology.com | Jon Zucker |Meenakshi Datta |Taylor Andelman
The U.S. Centers for Medicare and Medicaid Services (CMS) published a proposed rule on November 15, 2023 that would overhaul the regulations governing insurance agent and broker compensation rates and compensation agreements for Medicare Advantage plans (MAPs) and Medicare Part D plans (PDPs). The proposal follows CMS’ final rule revising the regulations governing marketing by MAPs issued on April 5, 2023, which we covered in a prior Sidley Update here.
