NPC Comments on CMS Request for Information on the Medicare Program

NPC's comments to CMS's recent request for information on the Medicare program focus on access, innovation and the importance of patient engagement. 


August 31, 2022

The Honorable Chiquita Brooks-LaSure
Administrator, Centers for Medicare & Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244

Submitted electronically via 

RE: Medicare Program; Request for Information on Medicare [CMS–4203–NC]

Dear Administrator Brooks-LaSure:

The National Pharmaceutical Council (NPC) appreciates the opportunity to submit comments regarding the Centers for Medicare & Medicaid Services (CMS) Request for Information (RFI), Medicare Program, Request for Information on Medicare. 

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. 

In response to questions in the RFI, NPC provides the following comments and recommendations, which we provide more detail on below:


  • Given the impact of utilization management tools on patient access, NPC asks that CMS consider best practices for step therapy and evaluate the impact of benefit design and utilization management on patient access.
  • We also ask that CMS actively safeguard patients against discrimination resulting from plan benefit design and application of utilization management. 


  • NPC supports CMS’s interest in value-based contracting and encourages the Agency to engage with stakeholders to clear additional barriers impacting the use of these arrangements. 
  • We also encourage the Agency to address gaps in quality measurement, including adding additional measures to capture the patient experience in the Medicare Advantage Star Ratings program.


  • NPC encourages CMS to ensure quality measures adequately capture the patient voice.
  • In addition, we recommend that CMS develop policies to support increased transparency and communication with patients regarding step therapy and other utilization management so that processes are transparent and efficient for the patient, ultimately improving patient engagement in the program.


10.    What steps could CMS take to ensure utilization management does not adversely affect enrollees’ access to medically necessary care?

NPC is concerned that plan use of utilization management, such as step therapy and prior authorizations, may impede patient access to needed medicines. Recent research published by the Medicare Payment Advisory Commission (MedPAC) found that Medicare beneficiaries face increasing access barriers for over half of all medicines covered in MA-PD plans.[1] In addition, a recent Office of the Inspector General report found that extra steps beneficiaries face to access medications are often for avoidable or inappropriate reasons.[2] These utilization management tools can increase the administrative burden for providers and delay patient access to treatment. NPC’s research suggests the use of step therapy increases treatment discontinuation and resource use.[3]

As the use of such tools can ultimately result in discrimination against individuals with significant health needs, we ask that CMS work to ensure that utilization management is based on high-quality clinical information, allows appropriate flexibility for patients with unique characteristics, and reduces redundant and burdensome steps. 

One area of concern is the use of step therapy. Currently, step therapy protocols can vary widely as there are no common standards for their development. Findings on the use of step therapy in commercial health plans provide insight into the utilization and design of these protocols in Medicare Advantage. According to research by NPC and Tufts Medical Center for the Evaluation of Value and Risk, there is a wide variation in the frequency with which plans apply step therapy in specialty drug coverage decisions. Utilization of step therapy ranged from 2 percent to 49 percent across the plans in the Specialty Drug Evidence and Coverage (SPEC) database, which obtains information from publicly available coverage decisions issued by 17 of the largest 20 commercial health plans and lines of business.[4]

Such variations in how health plans manage access to specialty medications can impact patients and mean that treatment might be significantly disrupted for patients whose conditions are controlled on one treatment, but the patient switches health plans. NPC’s research team convened a group of 16 stakeholders and experts—representing the patient, physician, payer, pharmacy, health policy, and ethics communities — to determine what should define appropriate step therapy standards and what these standards should include. In a study published in the Journal of Managed Care & Specialty Pharmacy,[5]  multiple stakeholders, including payer, provider and patient groups, agreed that the following criteria were important to developing, implementing, communicating, safeguarding and evaluating step therapy protocols: 

  • Clinical evidence before costs: Step therapy protocols should be based on up-to-date and comprehensive clinical evidence, patient perspectives, and clinical practice guidelines and be reviewed by an objective, unbiased, evidence-based group of experts.
  • Patients should face no more steps than are necessary: Implementation practices such as lengthy trials of treatments or interruptions in patient care are not appropriate.
  • Transparency and communication are critical: Communicating information on coverage decisions, the evidence that led to these coverage decisions, and how to navigate the processes can empower physicians, pharmacists, and patients.
  • Patient safeguards are needed: The development of exception criteria and an appeals process is critical to avoiding a “one-size-fits-all” approach to care that may leave patients with unique circumstances behind. Plans should respond in a timely manner to exception requests and appeals.
  • Evaluate the results: Any policy or protocol implemented to impact patient care should be evaluated to ensure it achieves the intended goals.

We recommend CMS encourage plans to consider this set of criteria for step therapy protocols to ensure that plan designs utilizing step therapy allow for patient access to care. 

We also encourage CMS to develop safeguards to protect patient access to care and ensure that plans do not discriminate against individuals with significant health needs. Additional guidance to plans with examples of discriminatory benefit design and utilization management tools would help support patient access to medically necessary treatment. In addition, we recommend that CMS proactively collect data and provide oversight to plans to ensure patients continue to have access to medically necessary treatments and prevent discriminatory practices that can create health inequities. These efforts by the agency will help support patient access to care for some of the country’s most vulnerable patients. 

11.    What data, whether currently collected by CMS or not, may be most meaningful for enrollees, clinicians, and MA plans regarding the applications of specific prior authorization and utilization management techniques? 

Considering our concerns regarding the unintended consequences for patients, we urge CMS to proactively collect data to evaluate the impact of such tools, particularly step therapy protocols, on health and administrative burden. Quality measures could be included in the Medicare Advantage program that examine step therapy requests for exceptions, approvals, denials, percent of appeals accepted and denied, and appeals sent for external review. Such data could help shed light on potential issues with patient access. Ensuring less burdensome processes can alleviate provider administrative efforts and reduce potential impacts on patient health. Routine evaluations of step therapy protocols can help identify whether further policies may be needed when certain protocols are no longer effective and if unintended consequences occur. Without such evaluation, the administrative costs may outweigh the potential impact of getting the right care at the right cost and optimizing patient health. This evaluation information could be considered in the formulary review of Medicare Advantage and Part D plans and various audit procedures, building on existing reporting requirements as part of the plan formulary review. 


3.    What steps within CMS’s statutory or administrative authority could CMS take to support more value-based contracting in the MA market? 

NPC supports value-based contracting as a promising avenue for promoting patient access to innovative therapies but notes there are currently barriers to the broader use of such agreements. NPC’s white paper, “Regulatory Barriers Impair Alignment of Biopharmaceutical Price and Value,” notes that the Federal Anti-Kickback Statute and Medicaid Best Price are key barriers to such agreements.[6],[7]

While recent regulatory efforts have addressed some of these barriers, additional regulatory changes are needed, including clarifying ambiguities and addressing operational challenges. We encourage CMS to engage with key stakeholders to solicit feedback on potential areas that would need additional clarification so that the Agency can address these barriers and clear the way for more value-based contracting. In addition, research indicates that future arrangements may benefit from a framework or other evaluative tool that can help manufacturers and payers assess the desirability of pursuing value-based contracting for a given product and guide negotiations and implementation.[8] Such a framework or tool could help facilitate future arrangements.

8.    Do the MA Star Ratings quality measures accurately reflect the quality of care that enrollees receive? If not, how could CMS improve the MA Star Ratings measure set to accurately reflect care and outcomes?

While NPC appreciates CMS’s prior efforts to ensure that quality measures reflect the quality of care received in the Medicare Advantage Star Ratings program, the program still has gaps. For example, though CMS has addressed areas including mental health, pain management, and diabetes, gaps remain in currently available measures related to dementia/cognitive impairment and co-morbid conditions that are particularly relevant for the Medicare population. Eighty percent of U.S. adults aged 65 and over have multiple chronic conditions.[9] We encourage CMS to develop clinically relevant measures in therapeutic areas representative of the Medicare population to appropriately assess the quality of care provided to address these gaps. Inclusion of additional outcome measures that address a broader range of conditions and medication management would strengthen the program and help ensure that it achieves its goals. 

CMS could also consider developing comprehensive measure sets that include a mix of measure types (i.e., outcomes and processes, disease-specific and cross-cutting, and clinical and patient-reported outcomes data sources) to ensure that measure sets provide a complete picture of the quality of care. 

We also urge CMS to continue adopting policies that 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.[10] 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.[11] By ensuring that the patient voice is a vital part of quality measurement, our health care system can promote better outcomes for all beneficiaries.

9.    What payment or service delivery models could CMMI test to further support MA benefit design and care delivery innovations to achieve higher quality, equitable, and more person-centered care? Are there specific innovations CMMI should consider testing to address the medical and nonmedical needs of enrollees with serious illnesses through the full spectrum of the care continuum?

NPC appreciates the Centers for Medicare & Medicaid Services (CMS) Center for Medicare and Medicaid Innovation (Innovation Center) (CMMI’s) existing efforts to examine the use of value-based insurance design (VBID) in Medicare Advantage. Though many payers and purchasers have established requirements for high cost-sharing for specialty medications that may trigger cost-related non-adherence for some patients, VBID is a key tactic that payers and purchasers can use to promote access to high-value medications. VBID offers the potential to achieve high-value care by reducing barriers to high-value clinical services and providers and discouraging the use of services and providers of lower value, aligning consumer incentives with value. NPC’s 2014 report,[12] co-authored with the Center for Value-Based Insurance Design at the University of Michigan, outlines some key considerations in the successful implementation of clinically nuanced benefit designs for specialty pharmaceuticals: 

  • Impose no more than modest cost-sharing on high-value medications; 
  • Reduce cost-sharing in accordance with patient- or disease-specific characteristics; 
  • Relieve patients from high cost-sharing after failure on a different medication; and 
  • Use cost-sharing to encourage patients to select high-performing providers and settings for their care.[13]

We ask that CMS incorporate such considerations as the Agency explores VBID in the MA program and encourage plans to apply such VBID principles and considerations in their overall plan design.


1.    What information gaps exist within the MA program for beneficiaries, including enrollees and other stakeholders? What additional data do MA stakeholders need to understand better the MA program and the experience of enrollees and other stakeholders within MA? What steps could CMS take to increase MA transparency and promote engagement with the MA program?

As noted above in our comments in section II regarding utilization management, NPC recommends that CMS work to collect data regarding the use of utilization management tools and its impact on providers and patient access to treatment. Such data could help shed light on potential issues with patient access and support CMS’s efforts to ensure health equity for all its beneficiaries, including those with significant health needs. 

Because step therapy can result in delays in treatment and negatively impact patient health outcomes, we recommend that CMS consider ways to enable greater transparency and communication of the step therapy processes to patients and providers and emphasize the potential to request exceptions. Per NPC’s research with key patient and provider stakeholders,[14] transparency and communication of any step therapy requirements to patients and providers are critical to minimizing patient and provider burden. For example, requirements regarding the step therapy protocol should be easily accessible via a public link on the plan’s website (e.g., CMS website) so patients can know what to expect as they navigate their health care. In addition, information regarding exceptions or appeals status, formulary review, formulary changes, and the transition processes should be shared with patients and easily accessible. Additional formal requirements around transparency and accessibility of the evidence used to develop step therapy programs and efforts to enable electronic communication between the patient and provider would aid providers and patients alike. Lastly, patients should be provided with information on the requirements to request exceptions, submit appeals for coverage decisions, and the option for an external review in an easily accessible format to ensure more transparent and efficient processes for the patient, ultimately improving patient engagement in the program.

3.    What steps could CMS take to enhance the voice of MA enrollees to inform policy development?

NPC supports CMS’s interest in incorporating patient voice to inform policy development within the MA program. As mentioned, the Agency can include patient experience by ensuring that data regarding beneficiary experiences are collected via quality measures. Complete, accurate, and transparent information regarding access problems, appeals, and complaints is critical to determining whether plans provide timely and appropriate access to needed care. Quality measures should capture patient interactions with health plans and providers and inform future health care decisions. We encourage the agency to ensure that patients receive high-quality customer service while minimizing barriers to care. We also encourage the Agency to refine its measures to support plan accountability regarding timely access to care and ensure that the collected data provides accurate and detailed information regarding beneficiaries’ access to therapy. Data integrity and completeness of appeals information is essential to ensuring that beneficiary access to high-quality care is not hindered. Furthermore, NPC encourages CMS to ensure that its quality measures for the MA program include measures based on patient-reported outcomes data sources alongside other measures to ensure that measure sets provide a complete picture of the quality of care and capture the patient’s voice and experiences. 

NPC appreciates CMS’s interest in soliciting feedback from stakeholders on how to improve the Medicare Advantage program. We look forward to continuing this conversation and would be happy to meet to expand upon our comments and share our research. 


John M. O’Brien, PharmD, MPH
President and Chief Executive Officer



[1] MedPAC. July 2022 Data Book: Health Care Spending and the Medicare Program. July 2022. 
[2] U.S. Department of Health and Human Services – Office of Inspector General. Some Medicare Part D Beneficiaries Face Avoidable Extra Steps That Can Delay or Prevent Access to Prescribed Drugs. September 2019. 
[3] Karmarkar T, Dubois RW, Graff JS. Journal of Managed Care & Specialty Pharmacy. 2021; 27(2):268-275.January 28, 2021
[4] Chambers, J., Kim, D., Pope, E., Graff, J., Wilkinson, C., and Neumann, P. (2018). Specialty Drug Coverage Varies Across Commercial Health Plans in the US. Health Affairs, 37(7), 1041-1047.
[5] Ibid.
[6] Academy of Managed Care Pharmacy (AMCP). AMCP Partnership Forum: Advancing Value-Based Contracting. 2017. J Manag Care Spec Pharm, 23(11):1096-1102.
[7] NPC. Regulatory Barriers Impair Alignment of Biopharmaceutical Price and Value. June 2018. 
[8] Mahendraratnam N, Sorenson C, Richardson E, Daniel GW, Buelt L, Westrich K, Qian J, Campbell H, McClellan M, Dubois RW. Value-based arrangements may be more prevalent than assumed. Am J Manag Care. 2019 Feb;25(2):70-76. 
[9] Buttorff, Christine, Teague Ruder and Melissa Bauman, Multiple Chronic Conditions in the United States. RAND Corporation, TL-221-PFCD, 2017. 
[10] National Quality Forum. Patient-reported outcomes. National Quality Forum website. Available at 
[11] Centers for Medicare and Medicaid Services. Meaningful Measures hub. 
[12] Fendrick AM, Buxbaum J, Westrich K. Supporting Consumer Access to Specialty Medications Through Value-Based Insurance Design. June 10, 2014. 
[13] Ibid.
[14] Chambers, J., Kim, D., Pope, E., Graff, J., Wilkinson, C., and Neumann, P. (2018). Specialty Drug Coverage Varies Across Commercial Health Plans in the US. Health Affairs, 37(7), 1041-1047.