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Oct 8, 2024 | 
lexology.com | Alice Valder Curran |Ken Choe |Melissa Bianchi |Joy Sturm |Allison Pugsley |Kathleen Peterson | +6 more
On October 2, 2024, the Centers for Medicare & Medicaid Services (CMS) issued final guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the Inflation Reduction Act (IRA) (“Final Guidance”). The Final Guidance largely represents a continuation of CMS’s IPAY 2026 approach.
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Sep 23, 2024 | 
jdsupra.com | Mahmud Brifkani |Ken Choe |Alice Valder Curran
September 23, 2024 Mahmud Brifkani, Ken Choe, Alice Valder Curran, Caroline Farrington, Xochitl Halaby, Samantha Marshall, Rianna Modi, Kathleen Peterson, Drew Savage Hogan Lovells + Follow x Following x Following - Unfollow Contact To embed, copy and paste the code into your website or blog: On September 20, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled: Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid...
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Sep 23, 2024 | 
lexology.com | Alice Valder Curran |Ken Choe |Kathleen Peterson |Samantha Marshall |Mahmud Brifkani |Rianna Modi | +4 more
On September 20, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled: Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program.
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Jul 30, 2024 | 
jdsupra.com | Mahmud Brifkani |Ken Choe |Alice Valder Curran
The Centers for Medicare & Medicaid Services (CMS) recently issued several important updates concerning the reporting of Average Sales Price (ASP) with potential implications for manufacturers.
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Jul 29, 2024 | 
lexology.com | Alice Valder Curran |Ken Choe |Stuart Langbein |Kathleen Peterson |Samantha Marshall |Mahmud Brifkani | +2 more
The Centers for Medicare & Medicaid Services (CMS) recently issued several important updates concerning the reporting of Average Sales Price (ASP) with potential implications for manufacturers.
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May 6, 2024 | 
lexology.com | Alice Valder Curran |Ken Choe |Susan Cook |Kathleen Peterson |Samantha Marshall |Lindsey Johnson | +3 more
On May 3, 2023, the Centers for Medicare & Medicaid Services (CMS) issued draft guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the IRA. Notwithstanding the agency’s oft-stated claim in litigation that its guidance for IPAY 2027 may differ from that for IPAY 2026, the draft guidance largely represents a continuation of CMS’s IPAY 2026 approach.
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Apr 22, 2024 | 
jdsupra.com | Mahmud Brifkani |Ken Choe |Alice Valder Curran
On April 19, 2024, the Health Resources and Services Administration (HRSA) published a final rule (Final Rule) in the Federal Register adopting several changes to the current administrative dispute resolution (ADR) process under the 340B Drug Pricing Program (340B Program). The Final Rule largely finalizes the policies in the proposed rule, dated November 30, 2022.
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Apr 3, 2024 | 
lexology.com | Ken Choe |Alice Valder Curran |Melissa Bianchi |James Huang |Samantha Marshall |Mahmud Brifkani | +1 more
On April 2, 2024, the Centers for Medicare & Medicaid Services (CMS) released the 2025 Notice of Benefit and Payment Parameters (NBPP) final rule (Final Rule), finalizing policies applicable to qualified health plans offered on health insurance exchanges as well as certain policies applicable to certain health plans more broadly.
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Mar 6, 2024 | 
jdsupra.com | Alice Valder Curran |Howard Levine |Cullen M. Taylor
Kicking off the webinar, Dr. Frederick Ch'en, partner in the Hogan Lovells Intellectual Property, Media, and Technology practice, APAC lead for Life Sciences, and Office Managing Partner of the firm’s Tokyo office, noted that whether or not your organization (or a competitor) has a product that has been selected for negotiation under the IRA, the impact of the legislation looms over the industry.
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Dec 19, 2023 | 
jdsupra.com | Mahmud Brifkani |Ken Choe |Alice Valder Curran |Kathleen Peterson
December 19, 2023 Mahmud Brifkani, Ken Choe, Alice Valder Curran, James Huang, Samantha Marshall, Rianna Modi, Kathleen Peterson Hogan Lovells + Follow x Following x Following - Unfollow Contact To embed, copy and paste the code into your website or blog: [co-authors: Drew Savage, Gabrielle Simeck] On December 14, 2023, the Centers for Medicare & Medicaid Services (CMS) published two “revised” guidance documents implementing the Medicare Part B and Part D inflation rebate provisions of the...
