CMS’s public explanations leave patients with questions about what evidence shaped negotiated prices and how their input was considered.
| pipc_blog_apx_8.17_final.pdf |
The Inflation Reduction Act (IRA) authorizes the Medicare Drug price Negotiation Program under which Maximum Fair Prices are established by the Centers for Medicare & Medicaid Services (CMS) for selected high-expenditure Medicare drugs. In reaching those prices, the law requires CMS to make judgments on factors that go to the heart of what matters to patients in their medical care – about therapeutic alternatives, comparative clinical benefit, therapeutic advances, and unmet medical need.
However, the short deadlines established by the IRA combined with CMS’ lack of specificity in implementation have left key questions unanswered about whether, and how, input from patients and people with disabilities and patient-centered outcomes are considered. To try to answer these questions, PIPC worked with leading experts to dig into the public explanations the agency released for its Maximum Fair Price (MFP) decisions. What we found did not inspire confidence. For example, as detailed in this blog, less than 2% of referenced studies described how patient involvement affected the study design. Further, referenced studies only rarely considered outcomes that matter to patients, such as caregiver burden or treatment convenience.
Our analysis looked at two key domains: first, how, if at all, was CMS considering patient input and patient-centered outcomes in its process; and second, to what degree was it citing studies that include cost-effectiveness analysis that employs the quality-adjusted life year (QALY). We reviewed the evidence cited for three drugs negotiated for Initial Price Applicability Year 2027.
The findings raise two basic concerns:
The disability community has long fought for federal policies restricting use of QALYs and similar measures. The Affordable Care Act (ACA) specifically prohibits Medicare from using a QALY, or a similar measure, in a way that discounts the value of a life because of an individual’s disability. The Inflation Reduction Act similarly includes additional protections against treating life extension for older adults, people with disabilities, and people with terminal illnesses as having lower value in the process of determining Maximum Fair Prices.
PIPC has a long history advocating for health care policies that are centered on the real-world experiences of patients and people with disabilities. As one Senator said during the IRA debate (p. S3858), Congress expected engagement and consultation of people directly impacted, including patients and people with disabilities, to inform CMS’ decisions. The law requires CMS to publish Maximum Fair Price Explanation documents identifying the evidence considered during negotiations. The documents offer some insight into the evidence used during the agency’s deliberations, but do not explain how CMS evaluates different types of evidence or weighs input from patients and people with disabilities.
Read our full analysis of these documents below.
However, the short deadlines established by the IRA combined with CMS’ lack of specificity in implementation have left key questions unanswered about whether, and how, input from patients and people with disabilities and patient-centered outcomes are considered. To try to answer these questions, PIPC worked with leading experts to dig into the public explanations the agency released for its Maximum Fair Price (MFP) decisions. What we found did not inspire confidence. For example, as detailed in this blog, less than 2% of referenced studies described how patient involvement affected the study design. Further, referenced studies only rarely considered outcomes that matter to patients, such as caregiver burden or treatment convenience.
Our analysis looked at two key domains: first, how, if at all, was CMS considering patient input and patient-centered outcomes in its process; and second, to what degree was it citing studies that include cost-effectiveness analysis that employs the quality-adjusted life year (QALY). We reviewed the evidence cited for three drugs negotiated for Initial Price Applicability Year 2027.
The findings raise two basic concerns:
- Evidence about patients’ priorities made up a small share of the literature, even when relevant patient-focused information was available, and;
- There are still some instances where CMS cites research using QALYs and cost-effectiveness thresholds, without providing sufficient information to demonstrate how the research was considered within the context of legal constraints.
The disability community has long fought for federal policies restricting use of QALYs and similar measures. The Affordable Care Act (ACA) specifically prohibits Medicare from using a QALY, or a similar measure, in a way that discounts the value of a life because of an individual’s disability. The Inflation Reduction Act similarly includes additional protections against treating life extension for older adults, people with disabilities, and people with terminal illnesses as having lower value in the process of determining Maximum Fair Prices.
PIPC has a long history advocating for health care policies that are centered on the real-world experiences of patients and people with disabilities. As one Senator said during the IRA debate (p. S3858), Congress expected engagement and consultation of people directly impacted, including patients and people with disabilities, to inform CMS’ decisions. The law requires CMS to publish Maximum Fair Price Explanation documents identifying the evidence considered during negotiations. The documents offer some insight into the evidence used during the agency’s deliberations, but do not explain how CMS evaluates different types of evidence or weighs input from patients and people with disabilities.
Read our full analysis of these documents below.
| pipc_blog_apx_8.17_final.pdf |
