Drug Price Negotiation & Health Equity
Since its founding, the Partnership to Improve Patient Care (PIPC) has been at the forefront of applying principles centered on patients and people with disabilities to the nation’s health care system – from the generation of comparative clinical effectiveness research at the Patient-Centered Outcomes Research Institute (PCORI), to the translation of evidence into care in a manner that achieves value to the affected patients and people with disabilities. Evidence should work to improve individual health decisions, not limit access to a one-size-fits-all health system.
Therefore, policies to determine the treatments worth providing - and the people worth treating - must protect against reliance on value assessments based on discriminatory metrics and evidence of effectiveness whose conclusions are based averages. Too often, policies fail people with disabilities and chronic conditions, older adults and communities of color who may be devalued by an algorithm or whose outcomes are not reflected in the data, exacerbating health inequity.
Therefore, policies to determine the treatments worth providing - and the people worth treating - must protect against reliance on value assessments based on discriminatory metrics and evidence of effectiveness whose conclusions are based averages. Too often, policies fail people with disabilities and chronic conditions, older adults and communities of color who may be devalued by an algorithm or whose outcomes are not reflected in the data, exacerbating health inequity.
IRA Implementation
The Inflation Reduction Act became law in August, 2022, and included provisions authorizing the Medicare to establish a “fair price” for certain drugs. We urge all stakeholders to take advantage of opportunities to use their voice to protect against disability bias and ensure consideration of outcomes that matter to patients.
Every life is valuable.
The statute calls for consideration of several factors that will require robust input from affected patients and people with disabilities to ensure that treatments for people with disabilities and chronic conditions are not devalued due to the inherent bias of historic research and value assessment methods. Factors include 1) judgements of a therapeutic advance, 2) comparative clinical effectiveness research that account for subpopulations including people with disabilities that protects against discrimination, and 3) the extent to which an unmet need may be met by the treatment.
We hope you will join PIPC in urging CMS to provide an iterative process of implementation with multiple points of input from patients and people with disabilities, as well as notice and comment as part of formal efforts to gather information as the agency establishes a formal and predictable engagement process for each selected drug. For example, it would be useful for CMS to have an ombudsman as a central point of contact for patients and people with disabilities to ensure early and routine engagement with affected patients and people with disabilities on negotiated drugs.
Help us call on CMS to sets standards protecting against the use of biased or discriminatory assessments of therapeutic value and to ensure systematic, robust, guaranteed, transparent engagement with affected patients and people with disabilities.
Every life is valuable.
The statute calls for consideration of several factors that will require robust input from affected patients and people with disabilities to ensure that treatments for people with disabilities and chronic conditions are not devalued due to the inherent bias of historic research and value assessment methods. Factors include 1) judgements of a therapeutic advance, 2) comparative clinical effectiveness research that account for subpopulations including people with disabilities that protects against discrimination, and 3) the extent to which an unmet need may be met by the treatment.
We hope you will join PIPC in urging CMS to provide an iterative process of implementation with multiple points of input from patients and people with disabilities, as well as notice and comment as part of formal efforts to gather information as the agency establishes a formal and predictable engagement process for each selected drug. For example, it would be useful for CMS to have an ombudsman as a central point of contact for patients and people with disabilities to ensure early and routine engagement with affected patients and people with disabilities on negotiated drugs.
Help us call on CMS to sets standards protecting against the use of biased or discriminatory assessments of therapeutic value and to ensure systematic, robust, guaranteed, transparent engagement with affected patients and people with disabilities.
Key Dates to Watch
Spring 2023
CMS committed that it will issue guidance on the negotiation process for 2026 and invite public comment on key elements.
- It will be important for CMS to hear input from patients and people with disabilities regarding:
- The methodology and data used to determine the maximum fair price, including reinforcement that the langue of the IRA clearly intends to bar the use of QALYs or similar discriminatory metrics.
- The role that patients and people with disabilities should play throughout the negotiation process, including clear comment opportunities and robust engagement of communities impacted by the selected drugs.
- View PIPC comments here.
Summer 2023
CMS committed that it will update its guidance for the negotiation process for 2026 and data collection requests and seek additional comment.
Fall 2023
September 1, 2023
The initial list of drugs subject to negotiation was published. This date marked the start of the negotiation process.
View PIPC’s statement here
October 1, 2023
The Secretary entered into agreements with the manufacturers of selected drugs.
The initial list of drugs subject to negotiation was published. This date marked the start of the negotiation process.
View PIPC’s statement here
October 1, 2023
The Secretary entered into agreements with the manufacturers of selected drugs.
SuMmer 2024
Fall 2024
Winter - Spring 2025
February 1, 2025
Deadline for CMS to have published selected drugs for negotiation for price applicability year 2027. View list published January 17, 2025, here.
View PIPC statement here.
March 1, 2025
As part of the Negotiation Data Elements and Drug Price Negotiation Process, members of the public were able to submit evidence about the selected drugs and their alternative treatments by March 1, 2025. View the final guidance for submissions here.
April 2025
In April, CMS held public engagement events to gather input on the second cycle of drugs selected for the Medicare Drug Negotiation Program, encouraging participation from patients, caregivers, clinicians, researchers, advocacy groups, and other stakeholders. These events included a series of closed roundtable discussions on each drug with selected patient representatives, as well as a public, livestreamed town hall focused on clinical considerations.
Following these events, CMS released redacted transcripts of the roundtable discussions and town hall meeting. For more information, visit CMS’ public engagement page and review the FAQ document.
May 12, 2025
CMS issued draft guidance for the third cycle of negotiations for the Medicare Drug Price Negotiation Program, along with additional information on CMS support for manufacturer effectuation of maximum fair prices (MFPs) in 2026, 2027, and 2028.
Deadline for CMS to have published selected drugs for negotiation for price applicability year 2027. View list published January 17, 2025, here.
View PIPC statement here.
March 1, 2025
As part of the Negotiation Data Elements and Drug Price Negotiation Process, members of the public were able to submit evidence about the selected drugs and their alternative treatments by March 1, 2025. View the final guidance for submissions here.
April 2025
In April, CMS held public engagement events to gather input on the second cycle of drugs selected for the Medicare Drug Negotiation Program, encouraging participation from patients, caregivers, clinicians, researchers, advocacy groups, and other stakeholders. These events included a series of closed roundtable discussions on each drug with selected patient representatives, as well as a public, livestreamed town hall focused on clinical considerations.
Following these events, CMS released redacted transcripts of the roundtable discussions and town hall meeting. For more information, visit CMS’ public engagement page and review the FAQ document.
May 12, 2025
CMS issued draft guidance for the third cycle of negotiations for the Medicare Drug Price Negotiation Program, along with additional information on CMS support for manufacturer effectuation of maximum fair prices (MFPs) in 2026, 2027, and 2028.
Summer 2025
June 1, 2025
For initial price applicability year 2027, CMS issued an initial written offer no later than June 1, 2025, and statutory written counteroffers, if applicable, were due from participating manufacturers of the selected drugs 30 days after receipt of the initial offer.
June 26, 2025
Public comments on the Draft Medicare Drug Price Negotiation Draft Guidance were due Thursday, June 26. CMS asked that comments be submitted directly to [email protected] with the subject line “Medicare Drug Price Negotiation Program Draft Guidance”.
For initial price applicability year 2027, CMS issued an initial written offer no later than June 1, 2025, and statutory written counteroffers, if applicable, were due from participating manufacturers of the selected drugs 30 days after receipt of the initial offer.
June 26, 2025
Public comments on the Draft Medicare Drug Price Negotiation Draft Guidance were due Thursday, June 26. CMS asked that comments be submitted directly to [email protected] with the subject line “Medicare Drug Price Negotiation Program Draft Guidance”.
Fall 2025
September 30, 2025
CMS issued updated guidance for the third cycle of negotiations for the Medicare Drug Price Negotiation Program following stakeholder feedback.
November 30, 2025
Deadline for CMS to have published any agreed-upon "Maximum Fair Prices" resulting from the second cycle of negotiations.
CMS issued updated guidance for the third cycle of negotiations for the Medicare Drug Price Negotiation Program following stakeholder feedback.
November 30, 2025
Deadline for CMS to have published any agreed-upon "Maximum Fair Prices" resulting from the second cycle of negotiations.
Winter - Spring 2026
January 1, 2026
Agreed-upon "Maximum Fair Prices" negotiated for selected drugs from the first cycle of negotiations became effective.
January 27, 2026
CMS announced the 15 additional Medicare Part B and D drugs selected for negotiation and one Part D drug selected for renegotiation for initial price applicability year 2028.
February 28, 2026
Drug companies with a selected drug for the third cycle of negotiations will have until February 28, 2026, to decide if they will participate in negotiations.
March 1, 2026
Deadline for CMS to publish Explanations of agreed upon "Maximum Fair Prices" resulting from the initial price applicability year 2027 negotiation process.
CMS also intends to solicit feedback from stakeholders before March 1, 2026, particularly with respect to patient experience with the conditions treated by drugs selected for price applicability year 2028, as well as therapeutic alternatives.
April 2026
Additionally, in April 2026, CMS intends to host patient-focused listening sessions for each of the 15 selected drugs in initial price applicability year 2028, as well as one town hall meeting focused on each of the clinical considerations of the selected drugs. Details of these public engagement sessions will be posted here.
Agreed-upon "Maximum Fair Prices" negotiated for selected drugs from the first cycle of negotiations became effective.
January 27, 2026
CMS announced the 15 additional Medicare Part B and D drugs selected for negotiation and one Part D drug selected for renegotiation for initial price applicability year 2028.
February 28, 2026
Drug companies with a selected drug for the third cycle of negotiations will have until February 28, 2026, to decide if they will participate in negotiations.
March 1, 2026
Deadline for CMS to publish Explanations of agreed upon "Maximum Fair Prices" resulting from the initial price applicability year 2027 negotiation process.
CMS also intends to solicit feedback from stakeholders before March 1, 2026, particularly with respect to patient experience with the conditions treated by drugs selected for price applicability year 2028, as well as therapeutic alternatives.
April 2026
Additionally, in April 2026, CMS intends to host patient-focused listening sessions for each of the 15 selected drugs in initial price applicability year 2028, as well as one town hall meeting focused on each of the clinical considerations of the selected drugs. Details of these public engagement sessions will be posted here.
Fall 2026
November 30, 2026
Deadline for CMS to publish negotiated prices for selected drugs for initial price applicability year 2028.
Deadline for CMS to publish negotiated prices for selected drugs for initial price applicability year 2028.
Winter 2027
January 1, 2027
Any agreed-upon "Maximum Fair Prices" negotiated for selected drugs from the second cycle of negotiations become effective.
March 1, 2027
Deadline for CMS to publish Explanations of agreed upon “Maximum Fair Prices” for selected drugs for initial price applicability year 2028.
Any agreed-upon "Maximum Fair Prices" negotiated for selected drugs from the second cycle of negotiations become effective.
March 1, 2027
Deadline for CMS to publish Explanations of agreed upon “Maximum Fair Prices” for selected drugs for initial price applicability year 2028.
Winter 2028
January 1, 2027
Any agreed-upon "Maximum Fair Prices" negotiated for selected drugs from the third cycle of negotiations and renegotiations become effective.
Any agreed-upon "Maximum Fair Prices" negotiated for selected drugs from the third cycle of negotiations and renegotiations become effective.
Tell Congress: Pass The Protecting Health Care for All Patients Act
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The Protecting Health Care for All Patients Act would advance the recommendation of the National Council on Disability calling for the bar on use of the quality-adjusted life year (QALY) and similar metrics that discriminate to be extended to all federal programs, including Medicaid.
We urge all Members of Congress to support this legislation as an important step forward to unambiguously bar QALYs and protect all people from health care discrimination. |
“As with the Americans with Disabilities Act, legislation barring QALYs in all federal programs can pass if Members of Congress on both sides of the aisle are determined to work together to get it done. Even in a divided Congress, there are issues such as ending disability discrimination in health care that everyone can agree on. I am grateful that Chair McMorris-Rodgers introduced the bill and is prioritizing its passage. Reach out to your Members of Congress to support the Protecting Health Care for All Patients Act as an important step forward to unambiguously bar QALYs and protect all people from health care discrimination."
- PIPC Chair Tony Coelho
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We will update this section routinely as open comment opportunities arise to protect patients and people from use of discriminatory metrics in health care decisions and to advance use of an evidence base that values health equity. Sign up using the form below to stay informed about the latest developments.
