Medicare Drug Price Negotiation Program Patient-Focused Listening Sessions

Medicare Drug Price Negotiation Program Patient-Focused Listening Sessions

 

IRA Questions

The Centers for Medicare & Medicaid Services (CMS) will host a series of patient-focused Listening Sessions this fall as part of the Medicare Drug Price Negotiation Program. The virtual public Listening Sessions will provide an opportunity for patients, beneficiaries, caregivers, consumer and patient organizations, and other interested parties to share input relevant to drugs selected for the first round of negotiations.

Listening Session Dates: The Listening Sessions will be held October 30 – November 15, 2023. Speaker registration will be open September 1 – October 2, 2023. 

The Listening Sessions are subject to change, including postponement and/or cancellation. 

CMS will host 10 Listening Sessions this fall, one for each of the 10 selected drugs:

  • Eliquis: Monday, October 30, 2023 at 12:00 – 1:30 PM EST 
  • Enbrel: Tuesday, October 31, 2023 at 12:00 – 1:30 PM EST
  • Entresto: Wednesday, November 1, 2023 at 12:00 – 1:30 PM EST
  • Farxiga: Thursday, November 2, 2023 at 12:00 – 1:30 PM EST
  • Fiasp; Fiasp FlexTouch; Fiasp PenFill; NovoLog; NovoLog FlexPen; NovoLog PenFill: Friday, November 3, 2023 at 12:00 – 1:30 PM EST
  • Imbruvica: Monday, November 6, 2023 at 12:00 – 1:30 PM EST
  • Januvia: Tuesday, November 7, 2023 at 12:00 – 1:30 PM EST
  • Jardiance: Wednesday, November 8, 2023 at 12:00 – 1:30 PM EST
  • Stelara: Tuesday, November 14, 2023 at 12:00 – 1:30 PM EST
  • Xarelto: Wednesday, November 15, 2023 at 2:00 – 3:30 PM EST

Listening Session Attendance and Registration

The Listening Sessions are open to the public and will be live streamed here.

Please note that registration is not necessary to view/attend the Listening Session livestream. Registration is only necessary to make a public statement at one or more Listening Sessions.

Opportunities for Public Input

CMS is interested in 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 will be listen-only; CMS will not be responding to feedback during the sessions.

There are two ways the public can share feedback and input related to the selected drugs.

Registering to Make a Public Statement at the Listening Sessions

Public Statement: Members of the public who have input on the selected drugs are encouraged to register for the chance to make a live, public statement at any of the 10 Listening Sessions.

You must register for the chance to speak.

REGISTER HERE. Registration will close at 11:59 PM PDT on October 2, 2023.

CMS expects a high level of interest in the Listening Sessions. CMS will use a process to randomly select speakers from among the individuals who register for the chance to speak. Approximately 20 speakers will be selected for each Listening Session. A confirmation email will be sent to selected speakers the week of October 9, 2023.

To accommodate as many speakers as possible during each session, public statements will be limited to no more than three minutes per person. To help speakers in planning remarks, CMS is providing 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

Because there are limited speaking opportunities during the Listening Sessions, CMS encourages the public to submit written input, if interested, in response to the 2023 CMS information collection request about selected drugs and evidence about alternative treatments. Submissions can 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. 

SUBMIT HERE. Information can be submitted between September 1 - October 2, 2023.

Guide: Information about How to Submit

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.”

Page Last Modified:
09/20/2023 09:23 AM