Negotiation Program Drug Selection for Initial Price Applicability Year 2028 (CMS-10844) - IRA

OMB 0938-1443

Latest Forms, Documents, and Supporting Material

Document Name
Form CMS-10844 Identification and Selection of Renegotiation-Eligible Drugs Form and Instruction
Form CMS-10844 Biosimilar Delay Form and Instruction
Form CMS-10844 Small Biotech Exception Without CGDP Agreement (Submitting Manufacture Acquired After December 31, 2021) Form and Instruction
Form CMS-10844 Small Biotech Exception Without CGDP Agreement (Submitting Manufacture Acquired Not After December 31, 2021) Form and Instruction
Form CMS-10844 Small Biotech Exception with CGDP Agreement (Submitting Manufacture Acquired After December 31, 2021) Form and Instruction
Form CMS-10844 Small Biotech Exception Form and Instruction
CMS -10844 Initial Price Applicability Year 2028_Negotiation Program Drug Selection Information Collection Supporting Statement - Part A.docx Supporting Statement A
CMS-10844 Initial Price Applicability Year 2028 60-day Negotiation Program Drug Selection ICR Responses to Public Comments.pdf Supplementary Document
CMS-10844 Initial Price Applicability Year 2028 60-day to 30-day Negotiation Program Drug Selection ICR Crosswalk.pdf Supplementary Document
CMS-10844 Crosswalk.pdf Supplementary Document
Identification and Selection of Renegotiation-Eligible Drugs Form and Instruction
Biosimilar Delay Form and Instruction
Small Biotech Exception Without CGDP Agreement (Submitting Manufacture Acquired After December 31, 2021) Form and Instruction
Small Biotech Exception Without CGDP Agreement (Submitting Manufacture Acquired Not After December 31, 2021) Form and Instruction
Small Biotech Exception with CGDP Agreement (Submitting Manufacture Acquired After December 31, 2021) Form and Instruction
Small Biotech Exception Form and Instruction