PIPC joined organizations representing patients, people with disabilities, family members, caregivers, veterans, seniors, providers, and others in response to the Advance Notice of Proposed Rulemaking released by the Center for Medicare & Medicaid Services (CMS) to utilize an “International Pricing Index” (IPI) to set reimbursement for medicines in Medicare Part B. The letter highlights concerns that this new policy would import QALY-based standards to key U.S. health programs. "Addressing health care costs, including drug prices, is an important and meaningful effort that should center on achieving outcomes that matter to those being served by health systems (patients, people with disabilities, veterans, seniors and other marginalized communities) such as improved quality of care and lower out-of-pocket costs," the letter states. "We are hopeful the Administration will reconsider their plan to import international cost-effectiveness standards into the U.S. and instead advance patient-centered, non-discriminatory approaches and establish meaningful protections for our communities in future demonstrations."
More than 90 leading advocacy organizations representing patients, people with disabilities, physicians, and caregivers wrote a letter to CVS Caremark in opposition to a new policy that would discriminate against individuals with disabilities and chronic illnesses.
In August, CVS announced that they would offer new insurance plans that exclude drugs if they exceed a subjective “cost-effectiveness” threshold. CVS would rely on a deeply flawed value assessment model developed by the Institute for Clinical and Economic Review (ICER) in determining whether treatments fall below a $100,000 “cost per quality-adjusted-life-year” limit. This type of cost effectiveness analysis discriminates against people with disabilities and other vulnerable groups like the elderly because it assigns higher value to people in “perfect health” than people in less-than-perfect health. As the letter states, "policy decisions based on cost-effectiveness ignore important differences among patients and instead rely on a single, one-size-fits-all assessment. Further, cost-effectiveness analysis discriminates against the chronically ill, the elderly and people with disabilities, using algorithms that calculate their lives as 'worth less' than people who are younger or non-disabled."
PIPC recently joined 50 leading organizations representing patients and people with disabilities in submitting a letter to the Centers for Medicare and Medicaid Innovation (CMMI) urging the agency to act on their statute’s call for alternative payment models to be evaluated based on patient-centeredness criteria. PIPC Chairman Tony Coelho emphasized that when it comes to payment model development, CMMI must engage patients early in their work to develop and implement new models. Specifically, the letter offers three concrete steps to establish the criteria called for by CMMI’s statute: (1) Establish the “patient-centeredness criteria” mandated under Section 1115A of the Affordable Care Act, which requires evaluation of alternative payment models (APMs) against patient-centeredness criteria; (2) convene patient and consumer advisory panels for each of the Innovation Center models under development as well as those currently being implemented; and (3) define “informed decision-making” as a core criterion of patient-centeredness and a goal of each alternative payment model.
In response to the Department of Health and Human Services (HHS) request for information (RFI) on the agency's Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs, PIPC has submitted a comment letter urging HHS to advance policies that emphasize the individual needs of patients. PIPC Chairman Tony Coelho encouraged HHS to make decisions that incorporate comparative clinical effectiveness research that works for patients to improve their health decisions, arguing for "informed healthcare that enables patients, doctors, and other health care professionals to choose the care that best meets the individual needs of the patient; and a health system that fosters continued medical innovation." The letter also includes four guiding principles for HHS to consider as they consider implementing new drug pricing policies, including: (1) avoid one-size-fits-all policies; (2) codify criteria for patient-centeredness across HHS programs; (3) convene patient advisory panels; and (4) focus on policies that advance informed healthcare.
PIPC Letter to MedPAC: Don’t Rely on Cost-Effectiveness to Make Coverage and Reimbursement Decisions
In a letter to the Medicare Payment Advisory Commission (MedPAC), Over 40 organizations representing patients, people with disabilities, and providers joined PIPC to express concerns about MedPAC’s consideration of cost effectiveness in Medicare. “We are concerned that the “incremental approach” suggested by commissioners may be intended to impose cost effectiveness over time, thereby avoiding intense scrutiny despite its methodological flaws and long-term impact on access to care. Additionally, such a policy recommendation would rely on overturning or undermining the law passed in 2010 by Congress banning Medicare from incorporating the QALY metric used in cost effectiveness analyses.
In response to a request for information from a bipartisan group of senators, PIPC has submitted comments on barriers to price and information transparency in health care. “When patients do not have access to information that allows them to assess the best available treatment for them, our health care system bears the cost of reduced treatment adherence, increased hospitalization and other acute care episodes, as well as the societal costs of increased disability over time. While insurers may see those costs in different buckets, patients do not. Your work could drive a more holistic perspective of healthcare centered on the patients and people with disabilities that are the ultimate beneficiaries of healthcare.”
In a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma, Partnership to Improve Patient Care (PIPC) Chairman Tony Coelho criticized the HHS Notice of Benefit and Payment Parameters for focusing on cost effectiveness and creating a national default definition of essential health benefits. While the notice proposes flexibility for states in defining essential health benefits, Chairman Coelho noted that the Notice of Benefit does not focus on how to align payment with achieving care tailored to individual patients. "It fluctuates between a policy of “anything goes” by allowing states increased flexibility in defining their benefit packages, and a “one-size-fits-all” policy relying on cost effectiveness reports to determine patient access to care," wrote Chairman Coelho. "To truly put patients first, CMS should instead embrace this as an opportunity to change the culture of our payment system to be patient-centered."
In a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma, Partnership to Improve Patient Care (PIPC) Chairman Tony Coelho submitted comments on behalf of PIPC in response to the Request for Information on a new direction to promote patient-centered care at the Center for Medicare and Medicaid Innovation (CMMI). Chairman Coelho urged CMS to implement "concrete reforms" in four key areas, including: (1) Defining a clear, consistent process for engaging patients and other stakeholders in development and implementation of CMMI evaluations; (2) Defining and adopting detailed criteria for patient-centeredness in CMMI evaluations; (3) Building on and strengthening the patient safeguards articulated in the RFI and; (4) Pursuing demonstrations that embody these reforms and put patients at the center of the health care.
In a letter to Department of Veterans Affairs Secretary David Shulkin, over 40 representatives of veterans, patients and people with disabilities expressed concern regarding the recently announced collaboration between the Institute for Clinical Economic Review (ICER) and the Department of Veterans Affairs (VA) Pharmacy Benefits Management Services office. They cautioned Secretary Shulkin about ICER's quality-adjusted-life-year (QALY) metric, citing its "potentially discriminatory" impact on people with disabilities and serious chronic conditions.
PIPC Submits Letter to HHS Expressing Concerns about MassHealth Section 1115 Demonstration Amendment Request.
In a letter to acting Health and Human Services Secretary Eric Hargan, Partnership to Improve Patient Care (PIPC) Chairman Tony Coelho expresses serious concerns with the proposal in the Massachusetts 1115 waiver amendment that would potentially limit access to new and innovative drug therapies. Chairman Coelho suggests to Secretary Hargan that the State of Massachusetts look to entities such as PCORI for insights on how to measure comparative effectiveness of treatments in real world situations. "We encourage states like Massachusetts to invest in the development of shared decision-making tools that reflect how treatments impact patients in real-world circumstances, so that patients are able to choose the treatment that is most effective for their individual needs," wrote Chairman Coelho. "You have an opportunity to partner with patients and people with disabilities to determine the outcomes that matter most to them in their treatment, measure those outcomes, and translate that information into tools that ensure patients get the right care at the right time."