Ken Choe

Oct 8, 2024 | jdsupra.com | Melissa Bianchi |Mahmud Brifkani |Ken Choe

CMS used the publication of the Final Guidance to also issue a number of related issuances: a revised template MFP file, a definitions document, and updated Information Collection Request (ICR) forms for data submission for small biotech exception and biosimilar delay requests. CMS is soliciting comment on the updated ICR forms, with comments due on November 1, 2024.

Oct 8, 2024 | jdsupra.com | Melissa Bianchi |Mahmud Brifkani |Ken Choe

CMS used the publication of the Final Guidance to also issue a number of related issuances: a revised template MFP file, a definitions document, and updated Information Collection Request (ICR) forms for data submission for small biotech exception and biosimilar delay requests. CMS is soliciting comment on the updated ICR forms, with comments due on November 1, 2024.

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.

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...

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.