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For Immediate Release
July 6, 2023 |
Contact: Thayer Roberts
[email protected] |
The Partnership to Improve Patient Care (PIPC) has issued the following statement on the Centers for Medicare and Medicaid Services' (CMS) final guidance on the Medicare Drug Price Negotiation Program.
Last week, the Centers for Medicare and Medicaid Services (CMS) issued final guidance related to the Medicare Drug Price Negotiation Program. CMS acknowledges the program is subject to the nondiscrimination language in the Inflation Reduction Act as well as in the Affordable Care Act. We appreciate CMS highlighting these prohibitions on the use of quality-adjusted life years (QALYs) and similar measures. While some have advanced the idea that pending House legislation, H.R. 485, the Protecting Health Care for All Patients Act, would somehow impact Medicare negotiation, we hope this acknowledgement from CMS that current law already bars the agency from using QALYs and similar measures will clear up that mischaracterization.
However, we remain concerned as to how CMS will use evidence that includes consideration of QALYs and similar measures of cost effectiveness. CMS cannot easily dissect cost effectiveness calculations from conclusions about a treatment’s clinical impact. We urge CMS to further clarify how the agency will judge whether the evidence being considered represents high quality, patient-centered evidence that is representative of the diverse patient population being treated, promotes health equity and excludes biased judgements of health improvement.
We also remain concerned that CMS left the door open to use of the equal value of life year gained (evLYG) metric, a prime example of efforts to replace the QALY with a metric that similarly incorporates unreliable calculations related to health improvement and quality of life. We appreciate CMS will evaluate the measures being used against the statutes banning QALYs and similar measures, but we also hope CMS will set explicit standards for use of only high-quality, patient-centered evidence in negotiations.
CMS responded to requests from patient and disability groups seeking formal opportunities for engagement by adding patient-focused listening sessions in the fall of 2023. Though a step in the right direction, we urge CMS to ensure that these listening sessions are part of a larger dialogue between CMS and stakeholders. We encourage CMS to go a step further to formalize a standardized process for patients and people with disabilities to engage throughout the process, including creating early opportunities for stakeholders to respond to CMS’ initial thinking on therapeutic alternatives and the negotiation factors. To facilitate this engagement, CMS should appoint an ombudsman dedicated to patient engagement, providing a clear and easy path to ensure these important viewpoints are heard and incorporated throughout the process.
We hope CMS will be transparent in the standards set for evidence considered to be high quality and patient-centered and look forward to future guidance creating more specific and formalized engagement of patients and people with disabilities that assures the agency incorporates their lived experiences into their decisions.
However, we remain concerned as to how CMS will use evidence that includes consideration of QALYs and similar measures of cost effectiveness. CMS cannot easily dissect cost effectiveness calculations from conclusions about a treatment’s clinical impact. We urge CMS to further clarify how the agency will judge whether the evidence being considered represents high quality, patient-centered evidence that is representative of the diverse patient population being treated, promotes health equity and excludes biased judgements of health improvement.
We also remain concerned that CMS left the door open to use of the equal value of life year gained (evLYG) metric, a prime example of efforts to replace the QALY with a metric that similarly incorporates unreliable calculations related to health improvement and quality of life. We appreciate CMS will evaluate the measures being used against the statutes banning QALYs and similar measures, but we also hope CMS will set explicit standards for use of only high-quality, patient-centered evidence in negotiations.
CMS responded to requests from patient and disability groups seeking formal opportunities for engagement by adding patient-focused listening sessions in the fall of 2023. Though a step in the right direction, we urge CMS to ensure that these listening sessions are part of a larger dialogue between CMS and stakeholders. We encourage CMS to go a step further to formalize a standardized process for patients and people with disabilities to engage throughout the process, including creating early opportunities for stakeholders to respond to CMS’ initial thinking on therapeutic alternatives and the negotiation factors. To facilitate this engagement, CMS should appoint an ombudsman dedicated to patient engagement, providing a clear and easy path to ensure these important viewpoints are heard and incorporated throughout the process.
We hope CMS will be transparent in the standards set for evidence considered to be high quality and patient-centered and look forward to future guidance creating more specific and formalized engagement of patients and people with disabilities that assures the agency incorporates their lived experiences into their decisions.
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