NPC Comments on CMS' Proposed Medicare Shared Savings and Physician Fee Policies

September 13, 2021

The Honorable Chiquita Brooks-LaSure
Administrator, Centers for Medicare and Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244
Submitted electronically via http://www.regulations.gov

RE: Medicare Program; CY 2022 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Provider Enrollment Regulation Updates; Provider and Supplier Prepayment and Post-Payment Medical Review Requirements.

Dear Administrator Brooks-LaSure:

The National Pharmaceutical Council (NPC) appreciates the opportunity to submit comments regarding the Centers for Medicare and Medicaid Services (CMS) notice of proposed rulemaking Medicare Program; CY 2022 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Provider Enrollment Regulation Updates; Provider and Supplier Prepayment and Post-Payment Medical Review Requirements (“CY 2022 PFS Proposed Rule”). NPC appreciates CMS’ continued efforts to improve quality measurement and promote coordinated, patient-centered care. NPC further supports CMS’ focus on identifying health equity data elements and standardizing collection to enhance quality reporting programs, as leveraging these data may help stakeholders assess and facilitate improvement of medication access barriers.

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 healthcare policy debates and supports the achievement of the best patient outcomes in the most efficient way possible.

Our comments will focus on the following:

• Priority areas for digital quality measure development;
• The proposals related to the Merit-based Incentive Payment System (MIPS) Value Pathways (MVPs) for Performance Year 2023 and future years;
• The request for feedback on changes to the quality measure set for MIPS; and
• The request for comments on modifications to the improvement activities (IA) inventory, including changes to “Drug Cost Transparency.”

CMS Should Address Patient-Reported and Other Cross-Cutting Quality Measurement Gap Areas When Enhancing its Digital Quality Measurement Portfolio

In the CY 2022 PFS Proposed Rule, CMS is requesting comment on four potential future actions that would enable transformation to a fully digital quality measurement enterprise by 2025:

1. Leveraging and advancing standards for digital data and obtaining all electronic health record (EHR) data required for quality measures via provider Fast Healthcare Interoperability Resources-based application programming interface,
2. Redesigning quality measures to be self-contained tools,
3. Improving support for data aggregation, and
4. Working to align measure requirements across our reporting programs, other federal programs and agencies, and the private sector where appropriate.

NPC agrees with the goals of the digital quality measurement initiative. Current systems for collecting quality measurement data do not adequately capture the information needed for meaningful outcome measures, including patient-reported measures (PRMs). NPC’s research finds that the use of PRMs, including patient-reported outcome measures (PROMs), patient-reported performance measures (PR-PMs), and patient-reported outcome performance measures (PRO-PMs), should be promoted as these measures have the potential to emphasize what is most meaningful to patients. [1]

Specifically, NPC and Discern Health published research in 2019 identifying key priority areas for PR-PM development, focused on cancer care, for use in value-based payment. These areas included patient-reported concepts focused on:

1. Symptoms interfering with daily activities,
2. Collection and conveyance of symptoms and functioning to providers,
3. Provider assessment of patients for emotional or social status or concerns and offer of referral to treatment, and
4. Consideration of patient goals and values across the treatment process. [2]

Patients’ views of quality may differ from those of providers and policymakers. In order to understand and hold clinicians accountable for these perspectives, CMS should prioritize PRMs developed in collaboration with patients and families as an area of focus in its digital quality measurement portfolio.  

NPC further recommends that CMS focus its digital quality measure development efforts on cross-cutting quality measures that apply broadly across clinical specialties. While many accountable care measure sets include some cross-cutting measures, measures related to medication adherence and access to specialists and non-physician clinicians remain limited. As described in NPC and Discern Health’s 2014 report “Accountable Care Measures for High-Cost Specialty Care and Innovative Treatment” gaps in cross-cutting measures include: lifestyle modification, education and monitoring for diet and exercise, health risk assessment, monitoring disease progression, comorbid condition referral/treatment, referrals to non-physician services, education, means to prevent disease transmission, and measures of clinical effectiveness. [3]

NPC recommends that CMS prioritize the advancement of PR-PMs and cross-cutting measures in its digital quality measurement portfolio and continue incorporating stakeholder feedback to ensure quality measures are meaningful and used effectively to improve patient care.

NPC Supports the Use of Patient-Centered Quality Measures and Activities in MVPs, Including Cross-Cutting Measures, Patient-Reported Measures (PRMs) and Measures Assessing Barriers to Medication Access

CMS is proposing to introduce MVPs in MIPS Performance Year 2023, starting with seven focus areas: advancing rheumatology patient care, coordinating stroke care to promote prevention and cultivate positive outcomes, advancing care for heart disease, optimizing chronic disease management, adopting best practices and promoting patient safety within emergency medicine, improving care for lower extremity joint repair, and patient safety and support of positive experiences with anesthesia.

NPC appreciates CMS’ efforts to incorporate elements that align with our recommendations for MVP development, specifically:

• Focusing on certain high-priority patient populations in addition to specific clinical specialties;
• Including a range of measure reporting mechanisms and a variety of different types of measures in the MVPs (e.g., clinical process, clinical outcome, and PR-PM);
• Including a range of quality measures that allow for Part B claims, clinical quality measures, and qualified clinical data registry reporting; and
• Emphasizing patient-reported measures of experience and outcomes, and process measures that assess collection of patient-reported data in proposed MVPs.

NPC supports the use of effective quality measurement to encourage the delivery of better, more appropriate care that is meaningful to patients and appreciates the opportunity to provide feedback to CMS. We would like to reiterate and emphasize that CMS should consider lessons from accountable care measure sets when proposing future MVPs. Our research finds that the use and development of outcome measures, cross-cutting measures, and PRMs should be promoted. [4]

Cross-Cutting Measures Allow for Efficient Assessment of Quality and Promote Care Coordination Across Multiple Conditions

Cross-cutting measures can incorporate care aspects that may not be addressed in other condition-specific quality measures. Such measures can facilitate the movement away from siloed measures and toward aligned measures promoting shared accountability. Since cross-cutting measures relate to multiple clinical conditions, they not only have a broader impact but can also reduce the burden for data collection. As a result, these measures can promote improved care coordination and are particularly useful for addressing complex issues of the growing population of individuals with multiple chronic conditions. CMS should continue incorporating cross-cutting measures in MVPs, especially MVPs that cover more than one clinical condition (e.g., chronic care management, emergency medicine). Cross-cutting measures are also important for conditions where personalized treatment is prioritized and where there are small case numbers (e.g., oncology) as they can generate larger denominators, mitigate burdensome data collection, and assess critical care processes and outcomes across patient populations.

For MVPs focused on diverse patient populations (e.g., oncology), NPC supports continuing to include a broader range of cross-cutting improvement activities (e.g., IA_EPA_1: “Provide 24/7 Access to MIPS Eligible Clinicians or Groups Who Have Real-Time Access to Patient’s Medical Record”). This includes MVPs where a variety of specialty-specific quality measures are needed to ensure that all eligible clinicians, such as specialists in specific cancer types, can participate. Including cross-cutting activities in MVPs will allow them to apply across a range of conditions and specialties.

NPC recommends that CMS prioritize the development of cross-cutting measures to address gaps related to medication adherence and access to specialists and non-physician clinicians, and that CMS consider the use of these measures and IAs in MVPs to allow them to be applicable for clinicians across different conditions and specialties.

Patient-Reported Measures (PRMs) Should Continue to be Prioritized for MVPs

Of the seven proposed MVPs for the 2023 performance period, five include at least one PR-PM or a process measure that assesses collection of patient-reported data. NPC appreciates this effort to advance patient-centered measurement in the MIPS program. CMS has emphasized its goal to focus on patient outcomes in quality measurement, with initiatives aimed at promoting patient preferences and voice in the measure development process. CMS should collaborate with patients, families/caregivers, and other stakeholders through existing avenues, such as the Measure Applications Partnership and the Meaningful Measures Initiative, to work toward the goal of achieving a patient-centered approach to measurement.

We encourage CMS to continue to develop and include cross-cutting PR-PMs when proposing future MVPs. Our research with Discern Health, published in 2019, emphasizes the importance of PR-PMs in oncology and outlines gaps in current measures. To close the gaps, we identified five core recommendations [5]:

1. Involve patients and caregivers throughout all aspects of the measures’ life cycle to ensure measures capture value;
2. Fill care phase and domain gaps in PRMs and PR-PMs (e.g., by offering grants and by developing PR-PMs that can fill the gaps);
3. Address methodological challenges (e.g., ensuring PR-PMs selected for VBP meet high standards of scientific rigor and applying risk adjustment to address the clinical and sociodemographic complexity of the patient population);
4. Reduce provider and patient burden by standardizing and aligning the use of PRMs and PR-PMs; and
5. Support providers in PRM and PR-PM implementation.

We encourage CMS to apply these recommendations in the development process for PR-PMs considered for future MVPs. While these recommendations were specific to oncology measurement, they should be applied to other clinical areas. Research has shown that patient-centered care and activation contribute to improved patient outcomes, better resource use, and decreased healthcare costs. [6],[7]

NPC recommends that CMS continue to incorporate PRMs in future MVPs, where possible, and ensure that patient input is accounted for in quality measurement and value-based payment.

Health Equity Measures May Address Barriers to Medication Adherence and Access

Through various proposals for the Quality Payment Program (QPP) and other policies within the CY 2022 PFS Proposed Rule, CMS has emphasized its interest in incorporating health equity measures to address barriers to care. NPC appreciates and supports CMS’ efforts to deliver equitable care to all populations.

In 2019, NPC and the Pharmacy Quality Alliance (PQA) convened an Access to Care Roundtable to develop a conceptual framework named the Medication Access Patient Journey (MAPJ). The aim of the roundtable discussion was to better define medication access and to identify priority gaps for future quality performance measurement targeting access to medications. Key barriers to medication access impacting specific populations included: [8]

• Organizational health literacy and provider competencies and beliefs;
• Patient’s health literacy, attitudes and beliefs;
• Availability of providers, transportation, and other public support;
• Patients’ medical conditions, race/ethnicity, gender, language, disability status, income, education, and community; and
• Access to medication based on the type of medical insurance and the costs of obtaining healthcare services.

The seven nodes identified within the MAPJ framework (Perceived Need, Help Seeking, Encounter, Prescribing, Prescription Adjudication, Prescription Dispensing, and Adherence) represent various stages, including the major barriers and challenges that exist and that patients encounter when receiving a medication.

NPC recommends CMS use this research and the MAPJ framework to guide the development of health equity measures that assess important barriers to medication access and adherence. These new measures should be used in MVPs.

Prioritize Future Development of an Oncology MVP

Cancer has a significant impact on the U.S. healthcare system, affecting a growing population of patients seeking healthcare services across the nation. The American Cancer Society estimates there will be 1.9 million new cancer cases diagnosed and 608,570 cancer deaths in the U.S. in 2021. [9] Considering the significant impact of oncology on the overall U.S. healthcare system, NPC believes that CMS should prioritize value-based payment and quality measurement of cancer care within the QPP.

Oncology is a complex branch of medicine that covers many site-specific diseases and patient types. CMS should consider this challenge when developing oncology MVPs, as multiple MVPs that focus on sub-populations of cancer patients (e.g., patients with individual types of cancer, patients with advanced or metastatic disease) may be more appropriate than an overarching oncology MVP. CMS should also design MVPs with cost measures that are appropriately balanced by meaningful quality measures that assess medication access and patient outcomes.

NPC recommends that CMS consider PRMs, including PRO-PMs, when proposing future oncology-related MVPs. Recognizing outcomes that are most important to patients (e.g., symptom management, quality of life) and ensuring care aligns with patient preferences, values, and goals can promote stronger patient engagement and better align incentives. The research that NPC and Discern Health conducted in 2019 identified high-priority areas for oncology PRO-PMs, including symptoms and symptom burden, physical functional status, care coordination, access to care, experience of clinical processes, goal attainment and care concordance, and shared decision-making.[10] NPC recommends that CMS seek to address these high-priority areas through PRMs in future oncology-related MVPs.

NPC recommends that CMS develop oncology MVPs that recognize the complexity of cancer diagnoses and treatments, effectively balance cost and quality measures, and incorporate meaningful PRO-PMs.

NPC Encourages CMS to Promote the Use of Patient-Reported Measures (PRMs) in the Traditional MIPS Program

Continue to Prioritize PRMs in the MIPS Quality Measure Inventory

In the CY 2022 PFS Proposed Rule, CMS proposed substantively changing 84 MIPS quality measures, removing 19 quality measures, and adding five quality measures for the 2022 performance period. NPC appreciates CMS’ continued efforts to improve quality measurement sets by reducing reporting burden and emphasizing outcomes within MIPS and the QPP more broadly.

NPC supports the proposed addition of the Person-Centered Primary Care Measure Patient-Reported Outcome Performance Measure (PCPCM PRO-PM), which focuses on a patient’s relationship with their primary care clinician or practice through a comprehensive set of patient-clinician interaction assessments. We encourage CMS to continue moving the QPP toward a model that ties payment to PRMs. As discussed, these measures should encompass patients’ views of quality, which may differ from those of providers and other stakeholders.

As CMS moves away from process measures and towards outcome measures, NPC recommends that PROMs should continue to be prioritized for development and use to ensure better care for patients served by clinicians participating in MIPS and the QPP.

Patient-Reported Performance Measures (PR-PMs) and Activities Should Address Key Domains of Patient-Centered Care

CMS proposes to modify IA_BE_1 “Use of certified EHR to capture patient-reported outcomes” by replacing examples of patient-reported outcomes with “current industry standards,” including functional status, symptoms and symptom burden, health behaviors, and patient experience. As CMS considers PRO examples for inclusion, and the prioritization of PR-PMs in MIPS and the QPP more broadly, NPC recommends focusing on priority areas that have been identified as being most meaningful to patients.

For example, research published in 2019 by NPC and Discern Health emphasized gaps and priorities in PRMs in oncology. Our findings include feedback from key stakeholders across the industry and emphasize goal attainment or care concordance as a gap area that should be addressed in future PRO-PMs. Symptoms and symptom burden is another high-priority area for PRO-PM implementation in value-based programs. Other high-priority concepts identified in our research for inclusion in accountable programs include psychosocial status, access to care, and socioeconomic status. [11]

Additional NPC and Discern Health research published in 2021 highlights the role of shared decision-making in healthcare and reinforces the importance of measuring patient-reported perspectives on its use. While research suggests that shared decision-making may not guarantee cost savings, it can increase medication adherence by promoting patient engagement and care concordant with patient preferences.[12]

In 2021, the Food and Drug Administration (FDA) published its “Core Patient-Reported Outcomes in Cancer Clinical Trials Guidance for Industry” and provided recommendations to sponsors for the collection of a core set of patient-reported clinical outcomes in cancer clinical trials. To maximize the utility of submitted PRO information, FDA recommended focusing on disease-related symptoms, symptomatic adverse events, overall side effect impact, physical function, and role function. [13] While this guidance focuses on clinical research, NPC believes that connections should be made between priorities for demonstrating the effectiveness of treatment and incentives for collecting PRMs and measuring performance in clinical workflow.

NPC recommends that CMS align with the FDA on PRM domains and priority concepts for quality measure development. Additionally, CMS should consider the benefits of PRMs that assess goal setting, shared decision-making, and care concordance with treatment plans.

CMS Should Develop IAs With a More Holistic Approach to Increasing Medication Access That Consider Medication Challenges and the Value of Treatment

In the CY 2020 PFS Proposed Rule, CMS adopted the “Drug Cost Transparency” IA to include requirements for real-time benefit tools (RTBTs) beginning in Performance Year 2020 and subsequent years. As previously finalized, use of an RTBT is optional. [14]

Drug Cost Transparency: To receive credit for this IA, MIPS eligible clinicians must attest that their practice provides counseling to patients and/or their caregivers about the costs of drugs and the patients’ out-of-pocket costs for the drugs. If appropriate, the clinician must also explore with their patients the availability of alternative drugs and patients’ eligibility for patient assistance programs that provide free medications to people who cannot afford to buy their medicine. One source of information for pricing of pharmaceuticals could be a real-time benefit tool (RTBT), which provides to the prescriber real-time patient-specific formulary and benefit information for drugs, including cost-sharing for a beneficiary. (CMS finalized in the Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out of Pocket Expenses final rule (84 FR 23832, 23883) that beginning January 1, 2021, Medicare Part D plans will be required to implement one or more RTBT(s)). [15]

The 2021 Consolidated Appropriations Act includes a provision called “Inclusion of Use of Real-Time Electronic Information in Shared Decision-Making Under MIPS,” which notes that this subcategory must include the use of an RTBT as an activity or component of another activity for performance periods beginning on or after January 1, 2022. In accordance with this provision, CMS is proposing to modify the “Drug Cost Transparency” IA to require the use of an RTBT beginning with the CY 2022 performance year and subsequent years. [16]

NPC agrees with the goal of this IA, which is to improve clinical practice or care delivery with the intent that it will result in improved patient outcomes via increased medication compliance and adherence. We agree that patient out-of-pocket cost is an important factor in medication underuse and may result in a higher likelihood for medical complications that increase healthcare resource utilization and costs.

However, we believe other priority factors beyond out-of-pocket costs should be considered when deciding on a treatment pathway for patients. Through our 2019 collaboration with PQA, the Access to Care Roundtable identified several medication access barriers, including: [17]

• Side effects;
• Low patient health literacy;
• Transportation and geographic location;
• Provider availability, language barriers, and/or cultural differences; and
• Insurance and formulary issues.

Clinicians should consider the full spectrum of variables, including but not limited to cost, that apply to individual patients when making treatment decisions. Under the proposed revisions, the IA establishes cost as the single most important factor when making prescribing decisions. RTBT can be a powerful tool to help providers and patients make the best decision for therapy, but these tools provide an incomplete perspective into the full spectrum of medication access considerations. NPC recognizes that CMS’ proposal is in response to the changes mandated under the 2021 Consolidated Appropriations Act.

Consistent with the Access to Care Roundtable recommendations and report, NPC recommends CMS develop and implement a screening tool for medication access challenges beyond cost that can be integrated into medication access IAs, in order to provide added context for conversations that involve RTBTs.

Value Discussions Must Consider More Holistic Views on Costs

NPC shares in the national priority to reduce national healthcare spending. However, we believe that the efforts to reduce spending must consider the ways health resources are used. NPC supports transparency and improved information access for all stakeholders, particularly patients, to promote informed decisions about appropriate care and lead to better health. Recent estimates indicate that prescription drug spending in the U.S. accounts for approximately 16% of all healthcare spending.[18] To achieve true transparency and efficiency, CMS should account for the other 84% of spending in its quality programs, including through MIPS IAs. As discussed during NPC and PQA’s Access to Care Roundtable, conversations about out-of-pocket costs alone may result in patients making short-term decisions without fully considering future costs or impact on clinical outcomes.

NPC recommends that IAs that promote discussions of value must reflect these factors, and discussions about cost should be considered in the context of benefits and alternatives.

NPC appreciates the opportunity to provide comments on the proposals above. We look forward to continuing to collaborate with CMS to promote patient-centered care and improve the health of Medicare beneficiaries. We hope to continue this important discussion with CMS and other stakeholders and would be happy to meet to expand upon our comments and share relevant research.

Sincerely,

John Michael O’Brien, PharmD, MPH
President and CEO

Kimberly Westrich, MA
Vice President, Health Services Research

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[1] Valuck T, Blaisdell D, Dugan DP, et al. Improving Oncology Quality Measurement in Accountable Care: Filling Gaps with Cross-Cutting Measures. J Manag Care Spec Pharm. 2017;23(2):174-181. doi:10.18553/jmcp.2017.23.2.174.

[2] Valuck T, Schmidt T, Perkins B, et al. Improving patient-reported measures in oncology. NPC website. https://www.npcnow.org/publication/improving-patient-reported-measures-oncology. Published February 21, 2019. Accessed August 21, 2021.

[3] McClellan M, Penso J, Valuck T, et al. Accountable care measures for high-cost specialty care and innovative treatment. NPC website. https://www.npcnow.org/publication/accountable-care-measures-high-cost-specialty-care-and-innovative-treatment. Published October 27, 2014. Accessed August 21, 2021.

[4] Valuck T, Blaisdell D, Dugan DP, et al. Improving Oncology Quality Measurement in Accountable Care: Filling Gaps with Cross-Cutting Measures. J Manag Care Spec Pharm. 2017;23(2):174-181. doi:10.18553/jmcp.2017.23.2.174.

[5] Valuck T, Schmidt T, Perkins B, et al. Improving patient-reported measures in oncology. NPC website. https://www.npcnow.org/publication/improving-patient-reported-measures-oncology. Published February 21, 2019. Accessed August 21, 2021.

[6] Gluyas H. Patient-centred care: improving healthcare outcomes. Nurs Stand. 2015;30(4):50-59. doi:10.7748/ns.30.4.50.e10186.

[7] Hibbard JH, Greene J. What the evidence shows about patient activation: better health outcomes and care experiences; fewer data on costs. Health Aff (Millwood). 2013;32(2):207-214. doi:10.1377/hlthaff.2012.1061.

[8] Pharmacy Quality Alliance & National Pharmaceutical Council. Access to care: Development of a medication access framework for quality measurement. PQA website. https://www.pqaalliance.org/assets/Research/PQA-Access-to-Care-Report.pdf. Published March 2019. Accessed August 21, 2021.

[9] American Cancer Society. Cancer facts & figures 2021. Cancer.org. https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2021.html. Accessed August 21, 2021.

[10] Valuck T, Schmidt T, Perkins B, et al. Improving patient-reported measures in oncology. NPC website. https://www.npcnow.org/publication/improving-patient-reported-measures-oncology. Published February 21, 2019. Accessed August 21, 2021.

[11] Valuck T, Blaisdell D, Dugan DP, et al. Improving Oncology Quality Measurement in Accountable Care: Filling Gaps with Cross-Cutting Measures. J Manag Care Spec Pharm. 2017;23(2):174-181. doi:10.18553/jmcp.2017.23.2.174.

[12] National Pharmaceutical Council (NPC). NPC shared Decision-making and value-based care research featured at PQA annual meeting. NPC website. https://www.npcnow.org/resources/npc-shared-decision-making-and-value-based-care-research-featured-pqa-annual-meeting. Accessed August 21, 2021.

[13] Food and Drug Administration. Core patient-reported outcomes in cancer clinical trials guidance for industry. FDA website. https://www.fda.gov/media/149994/download. Published June 2021. Accessed August 21, 2021.

[14] United States Department of Health and Human Services (HHS). Medicare Program; CY 2022 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Provider Enrollment Regulation Updates; Provider and Supplier Prepayment and Post-Payment Medical Review Requirements. Federal Register website. https://www.federalregister.gov/documents/2021/07/23/2021-14973/medicare-program-cy-2022-payment-policies-under-the-physician-fee-schedule-and-other-changes-to-part. Published July 23, 2021. Accessed August 21, 2021.

[15] Ibid.

[16] Ibid.

[17] Pharmacy Quality Alliance & National Pharmaceutical Council. Access to care: Development of a medication access framework for quality measurement. PQA website. https://www.pqaalliance.org/assets/Research/PQA-Access-to-Care-Report.pdf. Published March 2019. Accessed August 21, 2021.

[18] Kleinrock M, Westrich K, Buelt L, Aitken M, Dubois RW. Reconciling the Seemingly Irreconcilable: How Much Are We Spending on Drugs? NPC website. https://www.npcnow.org/resources/reconciling-seemingly-irreconcilable-how-much-are-we-spending-drugs. Published January 11, 2019. Accessed August 25, 2021.