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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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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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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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Nov 9, 2023 | 
lexology.com | Meenakshi Datta |Jaime L.M. Jones |Mark Langdon |Catherine Y. Starks
The U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) earlier this week released General Compliance Program Guidance (GCPG) applicable to all individuals and entities involved in the healthcare industry. As discussed in a prior Sidley Update, the GCPG is the first in a series of voluntary, nonbinding compliance program guidances (CPGs) that HHS-OIG intends to publish in response to stakeholder feedback.
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Jul 17, 2023 | 
lexology.com | Meenakshi Datta |Stephanie P. Hales |Elizabeth Hardcastle |Donielle McCutcheon |William A. Sarraille |Catherine Y. Starks | +1 more
In the past two weeks, the Centers for Medicare & Medicaid Services (CMS) unveiled important details regarding implementation of the Medicare Drug Price Negotiation Program (Negotiation Program) under the Inflation Reduction Act (IRA).
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May 31, 2023 | 
lexology.com | Catherine Y. Starks |Meenakshi Datta |Elizabeth Hardcastle |Donielle McCutcheon |William A. Sarraille |Trevor L. Wear | +2 more
On May 23, 2023, the U.S. Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that addresses a variety of important drug pricing matters under the Medicaid Drug Rebate Program (MDRP).
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Mar 20, 2023 | 
lexology.com | Meenakshi Datta |Stephanie P. Hales |Elizabeth Hardcastle |Donielle McCutcheon |Catherine Y. Starks |Trevor L. Wear | +2 more
On March 15, the Centers for Medicare and Medicaid Services (CMS) made a series of important announcements regarding implementation of the Inflation Reduction Act (IRA). Most crucially, CMS issued new initial guidance on implementation of the Medicare Drug Price Negotiation Program (Medicare Drug Price Program), with public comments due April 14, 2023. Notably, CMS did not issue the initial guidance through notice and comment rulemaking.
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Feb 23, 2023 | 
lexology.com | Elizabeth Hardcastle |Meenakshi Datta |Stephanie P. Hales |Donielle McCutcheon |William A. Sarraille |Catherine Y. Starks | +2 more
On February 14, the U.S. Department of Health and Human Services (HHS) that the HHS Secretary had selected three new payment and service delivery models for testing by the Center for Medicare & Medicaid Innovation (CMS Innovation Center). HHS has directed the CMS Innovation Center to test whether these new models result in lower prescription drug costs, promote accessibility to therapies, and/or improve quality of care.
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Feb 14, 2023 | 
lexology.com | Meenakshi Datta |Donielle McCutcheon |William A. Sarraille |Trevor L. Wear |Elizabeth Hardcastle |Catherine Y. Starks
The U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) has issued a Technical Assistance Brief (the Brief) identifying anticipated challenges the Centers for Medicare & Medicaid Services (CMS) will face in implementing the inflation-indexed rebates for Medicare Part B drugs under the Inflation Reduction Act (IRA). The Brief builds on findings from prior evaluations by HHS-OIG of potential Part B drug rebates.
