Guidance for Initial Price Applicability Year 2026

Frequently Asked Questions: Medicare Drug Price Negotiation Program for Initial Price Applicability Year 2026 (PDF) (January 5, 2024)

Medicare Drug Price Negotiation Revised Guidance (PDF) (June 30, 2023)

Fact Sheet: Medicare Drug Price Negotiation Revised Guidance (PDF) (June 30, 2023)

Public Comments: Medicare Drug Price Negotiation Program Initial Guidance (ZIP) (submitted by April 14, 2023)

Medicare Drug Price Negotiation Program Initial Guidance (PDF) (March 15, 2023)

Fact Sheet: Medicare Drug Price Negotiation Program Initial Guidance (PDF) (March 15, 2023)

Medicare Drug Price Negotiation Program: Next Steps in Implementation for 2026 (PDF) (January 11, 2023)

Drug Price Negotiation Timeline for 2026 (PDF) (January 11, 2023)

Information Collection Requests (ICRs) for Initial Price Applicability Year 2026

The Negotiation Data Elements ICR is available for viewing on OMB’s website. Click “all” to see full details.

The Drug Price Negotiation Process ICR is available for viewing on OMB's website.  Click “all” to see full details. 

The Small Biotech Exception ICR is available for viewing on OMB's website. Click "all" to see full details.

Patient-Focused Listening Session Redacted Transcripts

CMS hosted 10 Listening Sessions, one for each of the selected drugs, between October 30 - November 15, 2023. Below, find redacted copies of the patient-focused Listening Session transcripts. To maintain fidelity with speakers’ remarks, the transcripts reflect speakers’ language and word choices, including colloquial language. Names and other identifying data were redacted for patients, patient advocacy organization representatives, and family members/caregivers according to the Safe Harbor method.

• Eliquis: Monday, October 30, 2023 (Eliquis redacted transcript (PDF))  
• Enbrel: Tuesday, October 31, 2023 (Enbrel redacted transcript (PDF))
• Entresto: Wednesday, November 1, 2023 (Entresto redacted transcript (PDF))
• Farxiga: Thursday, November 2, 2023 (Farxiga redacted transcript (PDF))
• Fiasp; Fiasp FlexTouch; Fiasp PenFill; NovoLog; NovoLog FlexPen; NovoLog PenFill: Friday, November 3, 2023 (Fiasp-Novolog redacted transcript (PDF))
• Imbruvica: Monday, November 6, 2023 (Imbruvica redacted transcript (PDF))
• Januvia: Tuesday, November 7, 2023 (Januvia redacted transcript (PDF))
• Jardiance: Wednesday, November 8, 2023 (Jardiance redacted transcript (PDF))
• Stelara: Tuesday, November 14, 2023 (Stelara redacted transcript (PDF))
• Xarelto: Wednesday, November 15, 2023 (Xarelto redacted transcript (PDF))

Listening Session Attendance and Registration

The Listening Sessions were open to the public and were live streamed.

CMS used a process to randomly select speakers from among the individuals who registered for the chance to speak.

Opportunities for Public Input

The listening sessions provided an opportunity for patient-focused input relevant to the selected drugs, including information related to clinical benefit of the selected drugs as compared to therapeutic alternatives, how the selected drugs address unmet need, and how the selected drugs impact specific populations. The sessions were listen-only; CMS did not respond to feedback during the sessions.

To accommodate as many speakers as possible during each session, public statements were limited to no more than three minutes per person. To help speakers in planning remarks, CMS provided the following optional discussion topics:

• Patients’ day-to-day experiences living with the condition(s) treated by the selected drug, including how the experience may differ for different patient populations as well as patient caregivers and families.
• How the selected drug impacts patients, including both benefits and side effects, as compared to the therapeutic alternative(s), and which outcomes matter most to patients with the condition(s) treated by the selected drug.
• Patient experiences of access, adherence, and affordability of the selected drug as compared to therapeutic alternative(s).
• Any other information about the selected drug, the condition(s) it is used to treat, and other treatments used for that condition(s) that the speaker believes is important.

Submitted Statement

In addition to the opportunity to provide input during a listening session, the public was also able to submit written input between September 1 – October 2, 2023, in response to the 2023 CMS information collection request about selected drugs and evidence about alternative treatments. Submissions could include data on the selected drugs, therapeutic alternatives to the selected drugs, data related to unmet medical need and impacts on specific populations as well as the patient/caregiver experience. 

Contact Information

For further information about the Listening Sessions please contact CMS by email at IRARebateAndNegotiation@cms.hhs.gov with the subject line “Patient-Focused Listening Sessions.”