NPC Comments on Medicare and Medicaid Programs; Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program

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April 6, 2020

The Honorable Seema Verma
Administrator, Centers for Medicare and Medicaid Services
U.S. Department of Health and Human Services
200 Independence Ave., SW
Washington, DC 20201

Submitted via https://www.regulations.gov

RE: Medicare and Medicaid Programs; Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly

Dear Administrator Verma, 

Thank you for the opportunity to comment on the Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly. The National Pharmaceutical Council (NPC) shares the administration’s goal of building a health care system that delivers affordable, high-value care to Americans.

NPC is a health policy research organization dedicated to the advancement of good evidence and science and to fostering an environment in the United States that supports medical innovation. NPC is supported by the major U.S. research-based biopharmaceutical companies. We focus on research development, information dissemination, education and communication of the critical issues of evidence, innovation and the value of medicines for patients. Our research helps inform important health care policy debates and supports the achievement of the best patient outcomes in the most efficient way possible.

NPC welcomes policies that will lower out-of-pocket costs for patients and support efforts to increase medication adherence and improve patient outcomes.  Our comments today will focus on: 

  • Implementation of real-time benefit tools should take a stepwise approach to ensure that information is     accurate and reliable, and patients are given a complete sense of health care benefits, risks, and costs; 
  • Any changes to formulary tier and overall benefit design should ensure that patients maintain access to the needed medications; and
  • Increasing the weight of the patient experience category of the Star Ratings is a positive step towards enhancing the role of the patient experience in quality measurement. 

Implementation of Real-Time Benefit Tools Should Take a Stepwise Approach
In previous rulemaking, CMS finalized a requirement that Medicare Part D plans support a prescriber electronic real-time benefit tool (RTBT), which includes formulary and benefit information that could integrate with at least one e-prescribing or electronic health record (EHR) system beginning January 1, 2021. In this rule, CMS proposes that plan sponsors implement a beneficiary RTBT by January 1, 2022. This RTBT would include real-time formulary and benefit information, including formulary status of clinically appropriate alternatives, including any utilization management requirements. 

RTBTs can be powerful tools to help providers and patients make the best decision for therapy. As outlined in other documents, concerns still exist about the ability of Part D plan sponsors to meet the RTBT requirement. CMS originally proposed to support at least one RTBT by January 1, 2020. That proposal was subsequently finalized, but implementation was delayed until 2021 based on concerns from stakeholders that there is no national standard for RTBT and worry that the initial implementation timeline was overly aggressive. In response, CMS notes that the requirement for plan sponsors rests only to implement at least one RTBT, which can integrate with at least one prescriber electronic prescribing system, and there is no related requirement for widespread prescriber adoption of RTBT.[1]

We ask that CMS provide more clarity on 1) how alternatives will be defined and 2) what constitutes “clinically appropriate.” To achieve better health outcomes for both the individual patient and the broader population, individual treatment effects must be understood and reflected in determining what is clinically appropriate. This requires understanding the clinical consequence of delaying optimal treatment, the diversity in underlying patient attributes, the likelihood of response to similar treatments in similar ways, and patient preferences. For consumers using RTBT beneficiary tools, patient preferences may be easily understood. However, understanding the consequences of delayed treatment, how their personal attributes may differ from the “average” patient, or whether treatment alternatives will likely result in similar (or different) responses requires additional information.[2]

Providing a clear understanding of which treatments are considered options and the consequences of those treatment alternatives is needed for RTBT to help both patients and providers make the most informed treatment choice. 

NPC remains supportive of transparency and improved information access across the healthcare spectrum. When the necessary information is available to stakeholders, particularly patients, decisions about the appropriate care are more informed and can lead to better health. However, NPC is concerned that quick implementation of real-time benefit tools could cause uncertainty and confusion. We encourage CMS to take a stepwise approach to implementation and ensure that use of RTBT is done in a way that ensures patients and other stakeholders have a complete view of not only the relative costs of various treatment alternatives but also the benefits and risks of these choices.

Cost Transparency Tools Must Be Accurate, Reliable, and Consider Total Health Care Costs 
Considering the cost of medications prior to prescribing and discussing those costs with patients are important steps for clinicians to take. Likewise, providers have demonstrated a strong desire to share and discuss this information with patients. However, in a recent survey, providers also reported a lack of trust with available tools.[3]  

Further, cost information in real-time benefit tools will not provide patients with the full picture of health care costs. Prescription drugs account for only 16 percent of healthcare spending in the United States.[4] To achieve transparency and improve information access, the other 84 percent of spending should also be considered. Without appropriate evaluation, efforts to reduce health care costs may not be as effective as they could. 

The need to consider costs holistically was echoed at the Access to Care Roundtable recently convened by NPC and the Pharmacy Quality Alliance (PQA). Discussions on out-of-pocket costs alone may result in a patient refusing a prescription without consideration of potential future down-stream costs.[5] Not adhering to a prescribed medication or using the lowest cost treatment that is less effective, not effective, or harmful can result in higher downstream costs. The cost of prescription drugs should be viewed as the culmination of both direct and indirect costs, so providers, patients, and caregivers have a better understanding of overall health spending and health outcomes. NPC recommends that discussions of value must reflect the multitude of factors that impact cost, noting that costs must be considered in the context of benefits and alternatives, instead of merely considering out-of-pocket costs. 

Medication Adherence Goes Beyond Costs
Patient out-of-pocket costs are an important factor in medication underuse, with an estimated 14% of insured Americans not filling a prescription or skipping doses of a prescribed medicine due to cost.[6] Patients who underuse medications are significantly more likely to have complications, resulting in increased healthcare resource utilization (e.g., emergency department visits, hospitalizations, etc.) estimated to cost the U.S. health care system between $100 billion to $289 billion annually.[7],[8]

However, while cost is a key factor to consider when deciding on a treatment pathway for a patient, it is not the only factor. As part of the partnership with PQA and NPC, the multi-stakeholder Access to Care Roundtable developed a conceptual framework that better defines the medication access patient journey (MAPJ) and identifies priority gaps for future quality performance measurement based on commonly identified barriers. This research identified the following as barriers to adherence:

  • Side effects;
  • Low patient health literacy (e.g., not understanding the long-term health effect of hypertension and the need to take medication due to a lack of symptoms);
  • Transportation and geographic location;
  • Provider availability, language barriers, and/or cultural differences; and
  • Insurance issues, which include cost, as well as formulary changes that can lead to patients switching to medications that may be more costly or have a different side-effect profile than previous therapies.[9]  

When making treatment recommendations, clinicians should consider the full spectrum of variables that apply to individual patients making treatment decisions as outlined in the MAPJ barriers. While the use of a RTBT does not necessarily preclude providers from doing so, focusing on the drug costs as presented within that tool implies that the cost of the drug is the single most important factor when making prescribing decisions. Therefore, we urge CMS to adopt policies that address all the elements shown to impact adherence. Consistent with the Access to Care Roundtable recommendations and subsequent report, NPC recommends CMS develop and implement a screening tool for medication access challenges. This tool should include a screening for patient health literacy, real-world limitations such as patient access to a pharmacy in addition to the patient out-of-pocket prescription drug costs in the RTBT tools. 

RTBT checks are a tool to look at in the future, but not all systems can share alternatives and provide counseling services for all elements. Informing patients of out-of-pocket costs is an important, but incomplete element. NPC urges CMS to implement a stepwise approach to encouraging adoption of these tools once standards have been established, the activity includes a spectrum of medication access challenges, incorporates all benefits and costs, and allows for broader testing and adoption to occur. 

Any Changes to Formulary Tier and Overall Benefit Design Should Ensure that Patients Maintain Access to the Needed Medications
This proposed rule also puts forth a policy to allow Medicare Part D plans to include two specialty tiers in their benefit design instead of the standard single specialty tier that current exists in Part D. CMS would set a maximum allowable cost-sharing percentage annually and plans with two specialty tiers would use this maximum amount for the higher tier. 

Any changes to formulary design must maintain patient protections and ensure that patients have access to the medications they need. A treatment that is best for some patients may not be the right for other individuals. We urge CMS to consider the heterogeneity of treatment response if steps continue to implement a second specialty tier. Research has shown treatment responses vary among certain subpopulations, including for the elderly,[10] a key subpopulation among Medicare beneficiaries. In other cases, the variation comes within the symptoms patients with the same disease may experience, so multiple treatment options should be available to ensure that patients have access to the treatment they need. For some conditions, the consequences of delaying optimal treatment can be more serious than for others,[11] so patients must always have access to whatever medication provides the best, most effective treatment. 

In addition, within benefit and formulary design, options for formulary exceptions are needed. The information on which treatment works best for which type of patients is not always available so patients may be asked to use a lower-cost treatment first to see what will effectively treat their symptoms and/or condition. An expert roundtable discussion among patient, payer, and employer representatives agreed that patients who do not positively respond to these initial treatments should have access to the higher-cost therapy often at a lower out-of-pocket cost.[12] This strategy, known as “reward the good solider,” ensures that patients will have the necessary access to treatments they need and will not be further inconvenienced after trying multiple medications.  Patients should not be placed at a disadvantage, lose access, or be financially penalized if they require medications on a secondary specialty tier. 

Further, CMS should ensure the existing procedure to monitor formulary development protects patient access to medications. Should formulary designs change to include a second specialty tier, CMS, as the authority on the prescription drug benefit, must safeguard patient access, making sure that shifts in benefit design do not lead to unintended negative consequences for patients. Access and then subsequent adherence to a medication are key to ensuring positive health outcomes for Medicare Part D beneficiaries, and a change in benefit design should not negatively affect these. 

NPC Support Increasing the Weight of Patient Experience Category, Encourages CMS to Explore Opportunities to Further Incorporate Voice of the Patient into Quality Measurement
CMS is also proposing changes to the Star Ratings Program, including increasing the weight of the patient experience/complaints and access measures category to a 4. 

Patients are the most important source of information regarding experience and quality of life outcome, and we support CMS’ effort to ensure patients are a key part of quality measurement. NPC research on quality measurement, specifically in oncology value-based payment programs, revealed stakeholder concerns that “value” is often defined from the payer perspective and may not be meaningful to patients and family caregivers.[13] This concern extends from the design of programs that incentive providers to cut costs to the meaningfulness of the quality measures used to ensure that cost-cutting efforts do not undermine quality. By increasing the weight of the patient experience category, CMS is demonstrating the value and focus that plans operating in the Medicare Advantage and Medicare Part D markets must place on incorporating the voice of the patient and ensuring that plans will be held accountable based on patient input. While we agree this is an important step, this should not prevent further work to advance the assessment of patient experience in quality measures. 

Overall, NPC encourages CMS to continue adopting policies that further incorporate the patient voice into quality measurement. Including patients in quality development and measurement are consistent with the principles of national organizations and the strategic goals of CMS. NQF identifies patients as the most valuable and authoritative source of information in assessing the quality of health care.[14] CMS also has a strategic goal to “empower patients and doctors to make decisions about their health care” and a goal of the CMS  Meaningful Measures framework is to prioritize measures meaningful to patients.[15] By continuing to ensure that patient voice is a vital part of quality measurement, our health care system can promote better outcomes for all beneficiaries. 

Conclusion
NPC continues to support policies that will lead to lower patient out-of-pocket costs and overall health care costs while ensuring adequate patient protections. We urge CMS to use caution and take a stepwise approach to implementation and utilization of real-time benefit tools to ensure accurate and holistic information is available to patients. NPC also encourages CMS to consider patient out-of-pocket costs, but not at the risk of risking patient access and protections. CMS should closely monitor any changes in benefit design that may result from adding a second specialty tier so that no beneficiary loses access to the medications they need. Finally, NPC supports increasing the weight of the patient experience category and encourage the adoption of additional policies that would incorporate the patient voice into quality measurement. 

NPC appreciates the opportunity to provide comments on this proposed rule and look forward to continuing to collaborate with CMS to improve the health of Medicare beneficiaries. We hope to continue these important discussions with CMS and other stakeholders and would be happy to meet to expand upon our comments and share our research. 

Sincerely, 
 

Jennifer S. Graff, PharmD
Vice President, Comparative Effectiveness Research
National Pharmaceutical Council 
 

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[1] 84 FR 23849-51 (May 23, 2019).
[2] Graff, J.S., Grasela, T., Meltzer, D.O., and Dubois, R.W. (2014). Individual Treatment Effects: Implications for Research, Clinical Practice and Policy. American Journal of Managed Care. 2014; 20(7):544-551. Available at Available at: https://www.npcnow.org/publication/one-these-patients-not-others-considerations-individual-treatment-effects-research.
[3] CoverMyMeds. 2018 Real-Time Benefit Check National Adoption Scorecard Key Findings. August 20, 2018. https://www.covermymeds.com/main/insights/articles/2018-real-time-benefit-check-national-adoption-scorecard-key-findings/
[4] Kleinrock M, Westrich K, Buelt L, Aitken M, Dubois RW. Reconciling the Seemingly Irreconcilable: How Much Are We Spending on Drugs? Value in Health. 2019; 22(7): 792-798.
[5] Pharmacy Quality Alliance and National Pharmaceutical Council. Access to Care: Development of a Medication Access Conceptual Framework. March 2019. Available at https://pqa.memberclicks.net/assets/Research/PQA-Access-to-Care-Report.pdf.
[6] Osborn R, Squires D, Doty MM, Sarnak DO, and Schneider EC. In New Survey of 11 Countries, U.S. Adults Still Struggle with Access to and Affordability of Health Care. Health Affairs. 2016;35(12):2327-36.
[7] Heisler M, Choi H, Rosen AB, et al. Hospitalizations and Deaths Among Adults With Cardiovascular Disease Who Underuse Medications Because of Cost. Med Care. 2010;48(2):87-94.
[8] Viswanathan M, Golin CE, Jones CD, et al. Interventions to Improve Adherence to Self-administered Medications for Chronic Diseases in the United States. Ann Intern Med. 2012;157(11):785.
[9] Pharmacy Quality Alliance and National Pharmaceutical Council. Access to Care: Development of a Medication Access Conceptual Framework. March 2019. Available at https://pqa.memberclicks.net/assets/Research/PQA-Access-to-Care-Report.pdf.
[10] Wertheimer A. Pharmaceuticals for Elders: Why Innovation Matters. Healthcare and Aging. 2002; 9(1). Available at https://www.npcnow.org/system/files/research/download/Pharmaceuticals-for-Elders-Why-Innovation-Matters-1.pdf. Accessed June 12, 2019. 
[11] Graff, J.S., Grasela, T., Meltzer, D.O., and Dubois, R.W. (2014). Individual Treatment Effects: Implications for Research, Clinical Practice and Policy. American Journal of Managed Care. 2014; 20(7): 544-551. Available at: https://www.npcnow.org/publication/one-these-patients-not-others-considerations-individual-treatment-effects-research.
[12] Graff, J.S., Shih, C., Barker, T., Dieguez, G., Larson, C., Sherman, H., and Dubois, R.W. (2017). Does a One-Size-Fits-All Cost-Sharing Approach Incentivize Appropriate Medication Use? A Roundtable on the Fairness and Ethics Association with Variable Cost Sharing. Journal of Managed Care & Specialty Pharmacy. 23(6), 621-627. Available at https://www.jmcp.org/doi/ref/10.18553/jmcp.2017.16009.
[13] Valuck T, Schmidt T, Perkins B, Patel P, Westrich K, Basch E, McClellan M. Improving patient-reported measures in oncology. February 21, 2019. Available at. https://www.npcnow.org/publication/improving-patient-reported-measures-oncology.
[14] National Quality Forum. Patient-reported outcomes. National Quality Forum website. Available at https://www.qualityforum.org/Patient-Reported_Outcomes.aspx. 
[15] Centers for Medicare and Medicaid Services. Meaningful Measures hub. CMS.gov. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.  Updated September 10, 2019.