Public Comments

05/09/2016

FasterCures Comments on Proposed Medicare Part B Drug Payment Model

The Honorable Sylvia Mathews Burwell
Secretary
U.S. Department of Health & Human Services
200 Independence Ave., SW
Washington, DC 20201

Andrew M. Slavitt
Acting Administrator
Centers for Medicare & Medicaid Services
U.S. Department of Health & Human Services
200 Independence Ave., SW
Washington, DC  20201

Comments submitted via: www.regulations.gov. Available here. (Docket ID: CMS-2016-0036)
RE: Medicare Program; Part B Drug Payment Model

Dear Secretary Burwell and Acting Administrator Slavitt,

FasterCures welcomes the opportunity to comment on the proposed rule describing a new Medicare Part B Drug Payment Model (the “model”) proposed by the Centers for Medicare & Medicaid Services (CMS) in the Federal Register on March 11, 2016 (Docket ID: CMS-2016-0036). FasterCures, a center of the Milken Institute, is a think tank and catalyst for action determined to remove barriers to medical progress. We work with all stakeholders – academia, patient groups, philanthropies, industry, and government. Our commitment to expanding patients’ roles in the medical and health-care ecosystem is embodied in our Patients Count [1] program, which aims to build and support the science of patient input. As part of Patients Count, we are working to foster a reimbursement environment that incentivizes innovation and ensures life-saving therapies are accessible to patients, and to create opportunities for patient perspectives to inform value and coverage decisions.

FasterCures supports the model’s stated goal of “more efficient spending on quality care of Medicare beneficiaries.” In 2013, we began to study how value is defined in the health-care system because we were concerned that innovative medical products could emerge from the pipeline only to be inaccessible to patients. Therefore, our comments will focus on phase II of the model, which proposes to evaluate a series of value-based purchasing (VBP) tools. In short, any VBP tool used must meaningfully incorporate the patient perspective to determine the value of a medical product or intervention. Reliance on the current set of “value frameworks” to make these determinations will not be sufficient, as none of them includes substantially meaningful patient input.

Phase II: Applying value-based purchasing tools

In 2015, FasterCures convened two workshops bringing together stakeholders across the system to develop a shared understanding of different sectors’ capabilities and contributions to fostering patient-centered considerations of value, and to challenge the traditional boundaries of evidence generation and data standards that inform medical policy and coverage decisions. We have also produced briefing materials to educate patient organizations about the complex and changing health-care and insurance landscape and the roles they might play in influencing care and coverage decisions.[2]

CMS is proposing that phase II of the Medicare Part B model will apply one or more of four VBP tools to select drugs covered by Part B:

  1. Reference pricing
  2. Indications-based pricing
  3. Outcomes-based risk-sharing agreements
  4. Discounting or eliminating patient coinsurance for high-value drugs

As the model’s proposed rule notes, all four of these tools are being used today in the private sector. However, it is critical to understand that the definition of “value” – which is central to the overall effectiveness of any VBP strategy – is not uniform across the health-care system, and current methodologies to determine value may not encompass all parties, especially patients.

We believe that defining value is a necessary first step to understanding the impact of phase II on patient outcomes and system costs. However, the proposed rule goes into very little detail as to how CMS would define “value” for any of these four VBP tools. When discussing the impact of phase II (section IX. C.), the proposed rule states: “We do not believe that we have enough detail on the structure of the final value-based purchasing component to quantify potential savings.” 

Stakeholder engagement is critical. CMS Deputy Administrator Dr. Patrick Conway has said publicly, “We acknowledge that many of these [VBP] tools need further development and patient inputs… We look forward to your comments on this. [We will] have a public, open process where patients and consumers are the key people at the table to…help us define what are outcomes that are most meaningful to patients and how do we structure this work so that it is evidence-based and supports better outcomes for patients.”[3] We whole-heartedly endorse the approach described by Dr. Conway and see this letter as just the first step in a sustained, collaborative engagement among CMS, FasterCures, and the broader patient community to ensure that the agency is defining value in a way that benefits all members of the health-care ecosystem.

 Of particular interest to us are two passages in the proposed rule that address how CMS is considering defining value for phase II of the model.

First, in the discussion of indications-based pricing (section III. B. 2.), the proposed rule references the work being done by the Institute for Clinical and Economic Review (ICER) as an example of the evidence that CMS would use to make these value determinations. ICER reports[4] are one example of a series of efforts by organizations to establish value frameworks for drug pricing and other aspects of health care. Much of the focus to-date has been on cancer with the American Society of Clinical Oncology,[5] Memorial Sloan Kettering Cancer Center,[6] and the National Comprehensive Cancer Network[7] all developing value frameworks. Given that Part B encompasses many cancer therapies, we anticipate that CMS will look not only to ICER’s work but also to these three others as it seeks to define value for the model. However, based on our analysis of these four frameworks, none incorporates meaningful – qualitative or quantitative – input from patients into the definitions of and mechanisms for determining value.[8] 

Second, in the discussion of the outcomes-based risk-sharing VBP tool (section III. C. 1.), the proposed rule describes four data types that could be used to measure value:

  1. Long-term safety and outcomes
  2. Effect on an individual patient
  3. Patient adherence
  4. Impact on utilization and costs

While these four categories are relevant to understand health outcomes, they don’t address the full spectrum of value as determined by patients. This critical gap is starting to be addressed. The National Heath Council recently released a “Patient-Centered Value Model Rubric” to help the community evaluate value frameworks.[9] FasterCures and Avalere Health initiated a collaboration in 2015 to develop a patient-perspective value framework through a rigorous process and methodology that includes patient input as well as that of all other stakeholders.[10] Through that work, we have begun to define meaningful patient-perspective value considerations:

  1. value of the treatment to the individual patient, including an assessment of the clinical, functional, and quality-of-life benefits and harms of a treatment that accrue to the patient in the short term and over the long term, as well as factors such as dosing schedule, convenience, side effects, and mode of administration;
  2. the cost of the treatment to the patient, such as out-of-pocket spending, which will vary depending on an individual’s coverage and plan benefits, and will include the cost of related tests and other services required for access including travel (if care is available only in specialty settings), as well as costs avoided because of the treatment;
  3. the strength of evidence, which provides valuable information to patients because it guides them in understanding the reliability of the evidence being presented to them and to what extent a treatment is likely to show the benefits it is purported to have;
  4. shared decision making (SDM), which refers to the consideration of a patient and family member’s personal values and preferences when deciding on a treatment option; and
  5. the usability of the information provided by a value framework—for example, whether there is a patient-facing tool associated with the framework— that ensures access to meaningful, understandable information for SDM purposes.

CMS – in fact, all payers – will benefit from integrating patients and patient organizations into value determinations. We believe that:

  • Patient-relevant outcomes drive value. Payers need to understand how care is impacting patients’ functioning in the real world if they are going to pay for value.
  • Patient organizations have access to unique sources of real-world evidence in the form of patient registries, biorepositories, social networks, and mobile health initiatives and are often the most trusted intermediaries for and stewards of patients’ data.

We have announced a process to develop a patient-perspective value framework over the coming months.[11] We welcome the opportunity to work collaboratively with CMS and all stakeholders to define health-care value in a way that meaningfully encompasses the system’s customers – the patients.

Regards,

MA sig

Margaret Anderson
Executive Director
FasterCures, a center of the Milken Institute

 

Enclosure: “Integrating the Patient Perspective into the Development of Value Frameworks,” FasterCures and Avalere, March 2016.

 

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[3] Pew Charitable Trusts, Public Forum on the Medicare Part B Drug Payment Model, April 11, 2016. http://www.pewtrusts.org/en/about/events/2016/public-forum-on-the-medicare-part-b-drug-payment-model (Accessed, Apr. 25, 2016).

[4] http://www.icer-review.org/ (Accessed Apr. 26, 2016).

[5] http://www.asco.org/node/1091 (Accessed Apr. 26, 2016).

[6] http://www.drugabacus.org/ (Accessed Apr. 26, 2016).

[7] http://www.nccn.org/evidenceblocks/ (Accessed Apr. 26, 2016).

[8] The full analysis is appended to the end of this letter.

 

 

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