September 27, 2019
The Honorable Seema Verma
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 2020 Revisions to Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Establishment of an Ambulance Data Collection System; Updates to the Quality Payment Program; Medicare Enrollment of Opioid Treatment Programs and Enhancements to Provider Enrollment Regulations Concerning Improper Prescribing and Patient Harm; and Amendments to Physician Self-Referral Law Advisory Opinion Regulations [CMS-1715-P]
Dear Administrator Verma:
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 2020 Revisions to Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Establishment of an Ambulance Data Collection System; Updates to the Quality Payment Program; Medicare Enrollment of Opioid Treatment Programs and Enhancements to Provider Enrollment Regulations Concerning Improper Prescribing and Patient Harm; and Amendments to Physician Self-Referral Law Advisory Opinion Regulations (“PFS”). NPC supports the agency’s continued efforts to improve quality measurement and explore opportunities for more coordinated care.
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.
Our comments will focus on the following:
- The proposed inclusion of a new improvement activity in the Merit-based Incentive Payment System (MIPS) called “Drug Cost Transparency;”
- The request for feedback on development of the MIPS Value Pathways; and
- The request for feedback on the use of bundled payments in the Physician Fee Schedule.
CMS Should Replace the Drug Cost Transparency Clinical Improvement Activity With a More Holistic Approach to Increasing Medication Adherence and Compliance
Within the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program (QPP), providers are required to report on quality measures within four categories: quality, cost, improvement activities, and promoting interoperability. For 2020, CMS is proposing to add a new improvement activity:
Drug Cost Transparency: To receive credit for this improvement activity, 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)).
CMS Should Develop an Improvement Activity that Addresses the Spectrum of Medication Access Challenges
NPC agrees with the underlying premise and stated goal of this proposed improvement activity: to improve clinical practice or care delivery with the intent that it will result in improved patient outcomes via increased medication compliance and adherence. Patient out-of-pocket cost is 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.[i] 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.[ii],[iii]
However, while cost is an important factor to consider when deciding on a treatment pathway for a patient, it is not the only factor. Earlier this year, we partnered with the Pharmacy Quality Alliance (PQA) to publish a report on patient access to care and principles for developing a medication access framework for quality measurement. As part of the project, PQA and NPC convened a multi-stakeholder Access to Care Roundtable to develop 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.[iv]
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 proposed CMS improvement activity certainly does not preclude providers from doing so, it implies that the cost of the drug is the single most important factor when making prescribing decisions. Therefore, we urge CMS to refocus the improvement activity to capture the different elements that have been 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.
Discussion of Value Must Consider Benefits, Alternatives and More Holistic Costs
Reducing health care spending is a national priority. NPC shares in this priority. However, efforts to reduce health spending need to take into account the way health care resources are used. In 2018, NPC, along with 20 other stakeholders, launched the Going Below The Surface Forum initiative to broaden and improve the conversation around the use of health care resources. The initiative is aimed at better understanding the roots of the nation’s health investments by promoting a discussion that is firmly based in health policy and systems research.[v]
Grounded in this goal, NPC supports transparency and improved information access across the healthcare spectrum. When information is available to stakeholders, particularly patients, decisions about the appropriate care are more informed and can lead to better health. However, efforts to reduce health spending need to consider the way health care resources are used. First, prescription drugs account for only 16 percent of healthcare spending in the United States.[vi] To achieve true transparency, the other 84 percent of spending should also be accounted for in health care programs, including the improvement activities in the Merit-based Incentive Payment System (MIPS). Second, as recommended at the Access to Care Roundtable, costs must be considered holistically. Discussions on out-of-pocket costs alone may result in patient refusing a prescription without regard to the indirect cost related to engaging with the health system to obtain the medication or the down-stream costs.[vii] For these reasons, NPC recommends that discussions of value must reflect these factors and costs should be considered in the context of benefits and alternatives, rather than simply out-of-pocket costs. Prescription cost(s) should be viewed as the culmination of both direct and indirect costs.
Drug Cost Transparency Tools Must be Accurate and Reliable
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 be able to share and discuss this information with patients. However, in a recent survey, providers also reported a lack of trust with currently available tools.[viii]
RTBTs, which CMS requires Medicare Part D plan sponsors to adopt by January 1, 2021, 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 implement a requirement for Part D plan sponsors 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 current 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.[ix]
RTBT checks are a tool to look at in the future, but not all systems have the ability to 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.
NPC Supports the Use of Patient-Focused Quality Measurement in Development of the MIPS Value Pathways Using Cross-Cutting, Layered, Modular, and Patient-Reported Measures
In the Calendar Year 2020 PFS proposed rule, CMS is proposing to create a new option within the MIPS, the MIPS Value Pathways (MVPs) beginning with the 2021 performance year. MVPs would include quality measures that result in data of value to patients when evaluating clinicians and making decisions about their care. NPC supports the use of effective quality measurement to encourage the use of better, more appropriate care that is meaningful to patients and appreciates the opportunity to provide feedback to CMS.
In developing the MIPS value pathways, we encourage CMS to consider lessons from accountable care measure sets. NPC research finds that the use and development of outcome measures, cross-cutting measures, and patient-reported measures should be promoted.[x] The use of outcome measures ensures the collected data are meaningful to a variety of stakeholders, including patients, payers, and policy makers. Cross-cutting measures enable efficient assessment across multiple conditions, incorporating aspects of care that may not be directly addressed in other quality measures. Patient-reported measures incorporate what is important to patients and should be included in measure sets. In response to the request for comment regarding the types of performance measure collection types, NPC encourages CMS to incorporate multiple types of measures into the future MVPs and continue incorporating stakeholder feedback to ensure quality measures are used effectively to improve patient care.
Cross-Cutting Measures Can Efficiently Assess Quality Across Multiple Conditions and Promote Care Coordination
Cross-cutting measures efficiently assess quality across multiple conditions and aid in the movement from siloed activities and measures toward aligned measures that promote shared accountability. Because cross-cutting measures relate either indirectly or directly to more than one clinical condition, they can have a broader impact on quality measurement, while decreasing the burden of data collection. For these reasons, cross-cutting measures are particularly useful for addressing the complex issues of the large and growing population of individuals with multiple chronic conditions who benefit from a patient-centered approach to care coordination across their multiple conditions.[xi] For other conditions such as oncology or with personalized treatments, cross-cutting measures address the challenges associated with potentially burdensome data collection and challenges when evaluating quality when there are only a small number of cases among even medium to large provider practices.[xii]
Using the illustrative examples outlined in Table 34[xiii], the inclusion of MVPs for each specialty condition will likely require a large number of specialty-specific measures to ensure that all MIPS-Participating clinicians can participate. For these reasons, NPC does not recommend restricting MVPs to activities directly related to the clinical outcomes (e.g., IA_PM “Glycemic Management Services”) but instead include a selection of improvement activities which include cross-cutting measures (e.g., IA EPA “Provide 24/7 Access to MIPS Eligible Clinicians or Groups Who Have Real-Time Access to Patient’s Medical Record”) to allow MVPs to be applicable for clinicians across a range of conditions and specialties, one of the four guiding principles outlined in the proposed rule.
While many cross-cutting measures exist, measures related to medication adherence and access to specialists and non-physician clinicians remain limited. As outlined in the Accountable Care Measures for High-Cost Specialty Care, 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.[xiv] We recommend that similar measures are considered for in future measure development and possible future MIPS Value Pathways.
Layered and Modular Approaches Promote Effective Quality Measurement
NPC research has found two approaches that promote appropriate quality measurement while still accounting for patient feedback and minimizing provider administrative burden: the layered approach and the modular approach. These two approaches target measures to address existing gaps while minimizing the number of reported measures, thereby minimizing clinician burden.[xv] NPC suggests CMS consider using both layered and modular strategies when determining which measures physicians participating in a MVP will report.
The layered approach, as its name suggests, involves using measures at different levels that serve unique yet related goals. The levels in this approach can incorporate different types of measures, including patient-reported outcome measures, cross-cutting measures, appropriate use measures, and composite measures. The layered approach allows for the use of measures both externally and internally; external accountability to track population-level measures while internally, performance and improvement can be tracked at system-wide and provider levels. The graphic below outlines the layered approach using diabetes as a case study.[xvi]Source: Accountable Care Measures for High-Cost Specialty Care and Innovative Treatment. NPC and Discern Health.
The layered approach allows for external accountability (e.g., measures associated with complication rates or incidence of adverse reactions such as syncope related to hypoglycemia) at the population level while internally, performance (e.g., composite measures of HbA1C levels, LDL, and blood pressure) and improvement activities (e.g., ordering appropriate tests) can be tracked at system-wide and provider levels. Mapping the measures chosen for internal management to the external accountability measures is key for the layered approach because this promotes coordinated, focused, and comprehensive measurement while maintaining flexibility. [xvii] This layered approach promotes interoperability, connecting the goals outlined for MVPs as well as the existing four categories in the MIPS program.
In contrast, the modular approach uses a more specific set of measures to focus on improving quality for a specific subpopulation and supplement the general-purpose measure set used for the whole population.[xviii] Should MVPs be more focused or narrow, the modular approach allows for the targeted use of measures while still maintaining provider flexibility. Like the layered approach, multiple types of measures, including outcome measures, process measures, and cross-cutting measures, can all be used. Below is a graphic outlining the modular approach.Source: Accountable Care Measures for High-Cost Specialty Care and Innovative Treatment. NPC and Discern Health.
As outlined in the proposed rule, some public health priorities may require additional consideration. In the NPC and Discern Health Roundtable discussion, participants noted that modular measures are ideal for particular subpopulations or those conditions compatible with clinical data registries. Other conditions well-suited to the modular approach include those conditions treated at centers of excellence or specific patient populations such as newly diagnosed cancer patients and pediatric patients. However, such an approach also has challenges when the collection types are not consistent or comparable across centers or collections.[xix] Despite these challenges, NPC recommends a modular approach for certain high priority patient subpopulations rather than clinician populations. In response to CMS request for comments, rather than developing modular MVPs based on the specialty as outlined in the proposed rule, NPC recommends a using a modular approach for certain high priority patient subpopulations rather than clinician populations to ensure coordinated, patient-focused efforts.
Patient-Reported Measures Should be Prioritized
NPC also encourages CMS to move towards a system that ties payment to patient-reported performance measures (PR-PMs). Patients’ views of quality may differ from those of providers and policy makers. As the agency has moved away from process measures and towards outcome measures, more patient-reported measures should be developed and used to help ensure better care. Existing avenues, such as the Measure Applications Partnership and the Meaningful Measures Initiative, provide opportunities for CMS and other quality stakeholders to works towards this goal.
Patient-reported performance measures are particularly important when individual needs and preferences for treatment vary. Few existing PR-PMs address the impact of medications, decision-making, or care planning, which are measures that matter to patients. For example, patients being treated for breast cancer may have specific goals based upon the cancer stage, the characteristics of the tumor, or tolerance of certain treatment approaches. Recognizing outcomes that are most important to patients (e.g., symptom control, quality of life) as well as the patient understanding of the goals of care at key points (e.g., time of diagnosis, time of recurrence, and when further tumor-directed therapy becomes ineffective) can encourage stronger patient engagement and aligned incentives.[xx] While, PR-PMs may differ from condition to condition, where appropriate cross-cutting PR-PMs should be considered in future rule-making.[xxi]
For example, research published by NPC and Discern Health in 2019 found that the following strategies would be beneficial for improving patient-reported measures in oncology:
- Involving patients and caregivers throughout all aspects of the measures life cycle to ensure measures capture value;
- Filling care phase and domain gaps in patient-reported measures and PR-PMs;
- Addressing methodological challenges;
- Reducing provider and patient burden by standardizing and aligning the use of both PRMs and PR-PMs; and
- Supporting providers in PRM and PR-PM implementation.[xxii]
Across many conditions, research has shown that activated patients incur lower health care costs and experience fewer adverse events — shared goals of the MVP program to help clinicians improve care, engage patients, reward high-value care. Where possible, NPC recommends CMS consider using patient-reported measures. However, for patient-reported measures that are in the development phase, CMS should monitor progress, encourage development, and promote their use across quality programs.
Overall, NPC appreciates CMS’ continued efforts to improve quality measurement pathways within the Quality Payment Program, specifically, the Merit-based Incentive Payment System. We encourage CMS to consider more effective types of measures and ensure that the patient perspective is accounted for along the quality spectrum.
NPC Recommends a Cautious Approach to Instituting Bundled Payments, Ensuring Providers are Properly Reimbursed While Patients Still Receive Appropriate Care
In the PFS proposed rule, CMS requests feedback from stakeholders on expanding bundled payments to recognize efficiencies among the services paid for under the PFS. Bundled payments shift the financial incentives from payers to providers, creating intended benefits such as improved care management and coordination of services typically delivered together. However, there is also the potential for bundled payments to have unintended consequences such as underutilization of care or lack of access for the most costly patients. While NPC believes coordinated and bundled care is a laudable goal, we urge CMS to consider the three principles NPC outlined in a Health Affairs Blog to ensure that patients still receive the best possible care:
- Ensure bundled payments have sufficient reimbursement to achieve optimal patient outcomes;
- Incorporate evidence-based treatment variability, including risk adjustment; and
- Use quality metrics to ensure appropriate care.[xxiii]
Optimal Patient Outcomes Will Require Sufficient Reimbursement in Bundled Payments
If bundled payments are used, payments must appropriately reimburse providers for the resources required to achieve positive patient outcomes. To incentivize the use of appropriate care and encourage a focus on long-term impacts and not short-term process elements, payment bundles should be adjusted to compensate providers for the use of new, innovative technologies and time frames should be aligned with desired clinical outcomes. Allowing for the cost of new, innovative treatments has been a consistent challenge for bundled payment demonstrations in the past. As both CMS and providers continue to refine approaches to this challenge, any new bundled payment demonstrations must be designed in such a way that patients still maintain access to new and innovative therapies.
Additionally, bundled payments should only be used in target populations with sufficiently large populations that use homogenous services and medication to achieve the desired outcome of the payment. This will ensure that the bundled payment provides adequate reimbursement for the greatest number of patients instead of inadvertently putting providers at higher risk due to small numbers of patients or making patients in a varied target population vulnerable to inappropriate treatment.
Evidence-based Treatment Variability Should be Incorporated into a Bundled Payment
While bundled payments can be used to reduce treatment variability and incentivize providers to be mindful of resources, these payments should account for variability that may be caused by several factors, such as age, genetics, comorbid conditions, and personal preference. A one-size-fits-all approach can lead to financial hardships for providers when treating their sickest patients and patients may ultimately not receive the care they need. Risk adjustment can be used to account for variation and medications and services that are highly variable, high cost, and unpredictable can be excluded from the bundle to reduce the risks of financial loss and undertreatment of patients. Bundled payments should only be used if patient choice among clinically appropriate options is permitted. For example, women with stage I or stage II breast cancer may choose either breast-conserving therapy or a total mastectomy each with a different impact on costs. Incorporating patient choice into a bundled payment will ensure that patients receive the treatment they feel most comfortable with while still ensuring that a provider receives appropriate reimbursement for the resources required for treatment.
Quality Metrics Should be Incorporated to Ensure Appropriate Care for Patients
Effective use of bundled payments goes beyond providing sufficient reimbursement. To ensure that patients are receiving the appropriate care, bundled payments require oversight and incentives to use resources wisely. Quality metrics should be used to incentivize optimal care. When quality metrics cannot accurately assess the value of care, a bundled payment would not be appropriate. For example, one goal of diabetes care is lowering hemoglobin A1c to 7 percent. Setting a single performance threshold at this level could incentivize providers to focus only on their patients who could meet that threshold instead of their entire patient population rather than improving care delivery for all patients with diabetes regardless of their hemoglobin A1c level. Metrics should incorporate multiple performance thresholds so that physicians are incentivized to focus on the entire population covered by the bundled payment, not just the population subset who can achieve the goal. Further, quality metrics and financial metrics should be linked as an additional way to incentivize optimal care.
Overall, NPC believes that bundled payments can be a valuable tool when designed and utilized correctly. However, bundled payments must be deployed carefully, ensuring that patients and providers do not face unintended consequences that ultimately result in inappropriate treatment. Successful bundled payment programs would do the following:
- Begin with mostly homogenous patient populations and well-defined quality metrics and expand to additional areas as better risk adjustment and quality metrics become available;
- Include protections to safeguard patients, the most vulnerable stakeholder; and
- Emphasize aligning physician incentivize with the best interests of the patient.
NPC appreciates the opportunity to provide comments on the proposals above. NPC looks forward to continuing to collaborate with CMS to 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 our research.
Robert W. Dubois, MD, PhD
Chief Science Officer
National Pharmaceutical Council
Jennifer S. Graff, PharmD