January 27, 2022
The Honorable Chiquita Brooks-LaSure
Administrator, Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services
Attention: CMS-9911-P, P.O. Box 8016
Baltimore, MD 21244-8016
Submitted via https://www.regulations.gov
RE: Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2023 (CMS-9911-P)
Dear Administrator Brooks-LaSure:
Thank you for the opportunity to comment on the Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2023 (CMS-9911-P) proposed rule. The National Pharmaceutical Council (NPC) shares the Administration’s goal of building a health care system that delivers affordable, high-value care to all Americans.
NPC is a health policy research organization dedicated to advancing good evidence and science and 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 appreciates the agency’s efforts to improve patient access to care and health equity. To that end, our comments on the proposed rule focus on the following:
- Standardized Plans: NPC commends the Centers for Medicare & Medicaid Services (CMS) proposal to require issuers to provide standardized plan options at every product network type, metal level, and throughout every service area for plan year 2023 and encourages CMS to continue to work towards improvements in patient access to care with special consideration of health equity.
- Annual Limits on Cost-Sharing: While we appreciate CMS’s efforts to improve patient access to care and health equity, NPC is disappointed CMS did not address its current policy of excluding direct manufacturers’ support from annual cost-sharing limits. As this policy results in significant patient out-of-pocket costs and restricts access to care, we strongly encourage the agency to reevaluate its current policy and recommend it require plans disclose to enrollees whether and how copay accumulator adjustment programs (CAAPs) are being applied to improve transparency and protect patients.
- Essential Health Benefits (EHB) Nondiscrimination Policy and Health Plan Designs: NPC supports CMS’s efforts to refine its EHB nondiscrimination policy and include examples of presumptively discriminatory benefit designs such as adverse tiering. NPC recommends CMS continue to provide oversight, updates, and additional examples in regulations, as necessary, to ensure enforcement of the policy.
- Risk Adjustment Issuer Data Requirements: NPC is committed to efforts to improve health equity and has long conducted research about the importance of mitigating health disparities to advance equitable access to health care. As such, we support CMS’s proposal to collect and extract new data elements that would allow a more granular understanding of subpopulations to better identify and address disparities.
NPC strongly supports CMS’s proposal to require issuers in the Federally-Facilitated Marketplace (FFM) and State-Based Marketplaces using the Federal Platform (SBM-FP) to provide standardized plan options at every product network type, metal level, and throughout every service area for plan year 2023. Consumers currently have many plan options at each actuarial value or metal level, which can lead to confusion. Standardized plans can simplify the process of obtaining health insurance coverage for FFM and SBM-FP enrollees by streamlining plan choices. With standardized plans, consumers will be better able to focus on important differences regarding coverage and quality. In addition, we are supportive of CMS’s proposal to include patient-friendly cost-sharing parameters such as pre-deductible coverage for some metal tiers and utilization of fixed-dollar copayments across all tiers as such changes can lead to more predictable costs for patients and improve treatment adherence.
NPC further encourages CMS to take this opportunity in reintroducing the standardized plan options to ensure these standard plan options support the agency’s goals of health equity. In its approach to standardized plans, we recommend CMS take into account the following considerations noted in the Pharmaceutical Research and Manufacturers of America (PhRMA)’s comments  to last year’s proposed rule, Updating Payment Parameters, Section 1332 Waiver Implementing Regulations, and Improving Health Insurance Markets for 2022 and Beyond (CMS-9906-P):
- Communities of color are disproportionately impacted by certain chronic diseases for many reasons, including access to affordable health care and other social determinants of health. 
- Standardized health plan options can protect patients from rising out-of-pocket costs and eroding coverage that can exacerbate disparities. 
- Implementing standardized plans that prioritize making health care items and services more accessible and affordable is an important component in working towards health equity goals.
We are encouraged by the agency’s efforts to improve patient access to care and address health equity and look forward to ongoing engagement on these efforts.
Annual Limits on Cost-Sharing
Multiple studies have concluded that higher copayments and out-of-pocket costs lead to reduced medication adherence, worse disease control, and increased hospitalizations.     To minimize these unwanted outcomes amidst rising deductibles, copay assistance funds in the form of coupons or copay cards are frequently offered. However, health plans and pharmacy benefit managers have increasingly implemented copay accumulator adjustment programs (CAAPs) such as copay accumulator and copay maximizer programs preventing the assistance from counting towards plan deductibles or the annual limit on cost-sharing. As such, patients are exposed to greater out-of-pocket costs. The financial barrier created by CAAPs has been shown to lower treatment adherence and increase patient discontinuation — unwanted effects that can impact patient health. 
Given the impact of these programs on patient out-of-pocket costs, NPC is disappointed that CMS policy allows health plans to use CAAPs to exclude direct manufacturers’ support from annual cost-sharing. The policy increases patient out-of-pocket costs and threatens patient access to care; therefore, we strongly encourage the agency to reevaluate its current policy, which is counter to the Administration’s goals of improving patient cost-sharing and access to care. In addition, because the use of CAAPs is neither disclosed in the Summary of Benefits and Coverage nor elsewhere on the Marketplace, we also recommend the agency require issuers to disclose which Marketplace plans include copay accumulator adjustment programs and how they are being applied. In particular, as copay maximizer programs use the maximum value of copay cards to adjust patient out-of-pocket costs throughout the year, patients do not have access to how plans and PBMs apply this copay assistance and structure out-of-pocket costs for impacted drugs. Requiring additional transparency will protect patients by helping them understand how manufacturer assistance will be treated and allow Marketplace consumers to make informed decisions about care prior to enrollment.
Essential Health Benefits (EHB) Nondiscrimination Policy and Health Plan Designs
NPC strongly supports CMS’s proposal to refine its EHB nondiscrimination policy and include examples of presumptively discriminatory benefit designs such as adverse tiering. In particular, CMS’s clarification that benefit designs, specifically benefit limitations and plan coverage requirements, be based on clinical evidence is important to ensure that benefit designs are evidence-based and developed with scientific consensus. We also support the inclusion of illustrative examples of presumptively discriminatory benefit design, including adverse tiering. We are encouraged by CMS’s clarification that “relying on cost alone is an insufficient basis to defend an otherwise discriminatory benefit design” and notice to EHB issuers not to discriminate by discouraging enrollment of individuals with significant health needs. These efforts by the agency will help support patient access to care for some of the country’s most vulnerable patients. NPC recommends CMS continue to provide oversight, including updates and additional examples in regulations, as necessary, to ensure enforcement of the policy.
While we support the clarifications on this policy, we continue to have concerns regarding plans applying utilization management tools to discriminate against individuals with significant health needs. One particular area of concern is the use of step therapy in plan design. NPC’s research  suggests step therapy has been shown to increase treatment discontinuation and resource use. We recommend CMS encourage plans to consider this multi-stakeholder informed set of criteria, outlined below, for step therapy protocols to ensure that plan designs utilizing step therapy allow for patient access to care and do not discriminate against individuals with significant health needs. In an NPC study published in the Journal of Managed Care & Specialty Pharmacy , 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, 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 both exceptions criteria and an appeals process is critical to avoiding a “one-size-fits-all” approach to care that may leave behind patients with unique circumstances. Plans should respond in a timely manner to exception requests and appeals.
- Evaluate the results: Any policy or protocol implemented that can impact patient care should be evaluated to ensure it achieves the intended goals.
In addition to requiring that plan designs rely on clinical evidence, we ask that CMS also encourage the incorporation of value-based insurance design (VBID) principles into overall plan design. 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. Per NPC’s work on VBID , VBID is a model-driven by the concept of clinical nuance and involves several key principles: value equals the clinical benefit achieved for the money spent, health care services differ in the health benefits they produce, and the value of health care services depends upon the individual who receives them. NPC’s 2014 report 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. 
We ask that CMS encourage plans to apply VBID principles and considerations in their overall plan design.
Risk Adjustment Issuer Data Requirements
NPC is committed to efforts to improve health equity and has long conducted research about the importance of mitigating health disparities to advance equitable access to health care. In the past decade, research has deepened our understanding of a simple fact: People are different, and their health needs vary. Scientific leaps in precision medicine, an emerging body of research on differences in chronic disease outcomes, and a growing understanding of social determinants of health all point to this conclusion. As such, we support CMS’s proposal to collect and extract new data elements that would allow a more granular understanding of subpopulations to better identify and address disparities. We also encourage CMS to monitor and determine via outcomes measures whether interventions based on these insights have improved health for these subpopulations and whether disparities are being eliminated.
Good policy analysis begins with good research. The expanded data collection proposed will support both, particularly qualified researchers informing policy analysis about benefit design and equitable access to medication use and other health care services. Though differences among patients are common, these differences aren’t always considered in treatment and coverage decisions. NPC’s recently re-released Myth of Average  report explores the barriers patients face when navigating the health care system and identifies opportunities for health care decision-makers to build better health care benefits and improve patient access to needed treatments.
NPC appreciates the opportunity to comment on this proposed rule and looks forward to working with you on future rulemaking. We are happy to discuss these comments if helpful and provide any further detail you request.
John M. O’Brien, PharmD, MPH
President and Chief Executive Officer
 PhRMA. Comments to Patient Protection and Affordable Care Act; Updating Payment Parameters, Section 1332 Waiver Implementing Regulations, and Improving Health Insurance. Markets for 2022 and Beyond Proposed Rule (CMS-9906-P). July 28. 2021. https://www.regulations.gov/comment/CMS-2021-0113-0247.
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 Kaiser Family Foundation. “Disparities in Health and Health Care: 5 Key Questions and Answers”. 2021. https://www.kff.org/racial-equity-and-health-policy/issue-brief/disparities-in-health-and-health-care-5-key-question-and-answers/.
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 Westrich K, Buelt L. The Myth of Average: Why Individual Patient Differences Matter. January 2022. https://www.npcnow.org/sites/default/files/2022-01/The_Myth_of_Average_01.2022.pdf.