March 6, I. Quality: Star Ratings, Drug Utilization Review, and Medication Therapy Management (MTM)

Transcription

1 March 6, 2015 [Submitted electronically to Centers for Medicare and Medicaid Services Department of Health and Human Services Attention: CMS-4159-P P.O. Box 8013 Baltimore, MD Re: Advance Notice of Methodological Changes for Calendar Year (CY) 2016 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2016 Call Letter Dear Sir/Madam: APhA is pleased to submit these comments regarding the CY 2016 Call Letter (the Call Letter ). Founded in 1852 as the American Pharmaceutical Association, APhA represents more than 62,000 pharmacists, pharmaceutical scientists, student pharmacists, pharmacy technicians, and others interested in improving medication use and advancing patient care. APhA members provide care in all practice settings, including community pharmacies, hospitals, long-term care facilities, community health centers, physician offices, ambulatory clinics, managed care organizations, hospice settings, and the uniformed services. APhA would like to offer CMS its feedback on the Call Letter s provisions in three key areas: quality, provider networks, and pricing and delivery. We address each area separately below. I. Quality: Star Ratings, Drug Utilization Review, and Medication Therapy Management (MTM) A. Enhancements to the 2016 Star Ratings and Beyond i. Medication Therapy Management Program Completion Rate for Comprehensive Medication Reviews (Part D) (p. 86) APhA supports the Medication Therapy Management (MTM) Program Completion Rate for Comprehensive Medication Reviews (CMR) measure as a mechanism for evaluating the uptake of the MTM benefit by beneficiaries. In 2014, CMS reported in the Medicare Part D Proposed Rule that access to MTM services remains very low, with MTM program eligibility rates at less than 8 percent in 2011, despite a CMS beneficiary eligibility goal of 25 percent. We believe that the CMR Completion Rate measure will incentivize plans to increase outreach

2 APhA Comments to CMS re: CY 2016 Call Letter Page 2 of 8 efforts to beneficiaries who can benefit from these services. While we agree that this measure should receive a weight of 1 in its inaugural year, we encourage CMS to continue to monitor its impact to determine whether a weighting increase would further optimize the measure. ii. Beneficiary Access and Performance Problems (p ) APhA supports the reintroduction of CY 2014 measure Beneficiary Access and Performance Problems. Relatedly, we recommend that plans be evaluated on how restrictive their preferred networks are, especially in rural and medically underserved areas, where restrictive networks may compromise beneficiary access. When pharmacies are allowed to accept the contract terms of the plan or plan s pharmacy benefit manager, preferred networks broaden, meaning more beneficiaries will have access to lower cost sharing levels. iii. Controlling Blood Pressure (p. 88) APhA encourages alignment of metrics with evidence-based guidelines and supports the modification of the Controlling Blood Pressure measure to include updated evidence-based guidelines in the quality parameters. iv. Medication Adherence (for Diabetes Medications and Hypertension (RAS antagonists)) and Diabetes Treatment (p. 91) APhA supports CMS s adoption of the Pharmacy Quality Alliance s ( PQA s ) 2014 updated specifications to exclude End-Stage Renal Disease ( ESRD ) patients from the denominator of three measures: Adherence to Diabetes Medications, Adherence to Hypertension (RAS antagonists), and Diabetes Treatment. Furthermore, APhA recognizes that identifiers obtained from the Medicare Enrollment Database ( EDB ) are more accurate, accessible, and frequently updated for all Part D beneficiaries. Therefore, APhA supports the use of EDB data to identify patients included in the denominator. v. Medication Adherence (Diabetes Medications, Hypertension (RAS antagonists), and for Cholesterol (Statins)) (p. 9) APhA agrees that CMS should use the exact death date, when available in the Common Medicare Environment ( CME ) enrollment table, instead of the disenrollment date at the end of the beneficiary s measurement period for the following adherence measures: Diabetes Medications, Hypertension (RAS antagonists), and Cholesterol (Statins). CMS s use of the exact death or disenrollment date will yield more accurate reports and better align with the PQA measure criteria. vi. Obsolete NDCs (Part D) (p. 93) APhA agrees with CMS s proposal to implement PQA s 2014 obsolete date methodology for the 2016 Star Ratings and display measures. This is the methodology that is used to develop the National Drug Code ( NDC ) lists for PQA measures. Active NDCs, as well as those with obsolete dates within the measurement year or six months prior to the beginning of the measurement period, are included in the NDC list.

3 APhA Comments to CMS re: CY 2016 Call Letter Page 3 of 8 vii. Dual/LIS Status (p ) APhA believes that continued examination of the connection between higher dualeligible and Low Income Subsidy ( LIS ) beneficiary enrollment in Medicare Advantage ( MA ) and Prescription Drug Plans ( PDP ) and lower Star Ratings is warranted because the challenges these populations face can create barriers to continuous health care. We applaud CMS for examining risk adjustment methods that take socioeconomic status or other sociodemographic factors into consideration. While APhA can accept a weight reduction from 3 to 1.5 for the Medication Adherence for Hypertension (RAS antagonists) measure, we caution that continued monitoring of plan performance on the measure is vital to ensure that patient care and outcomes are not adversely impacted by the change. While providing an interim solution to address risk adjustment issues, we remain concerned that this change could have the unintended consequence of plans placing less emphasis on hypertension medication adherence. viii. Medication Reconciliation Post Discharge (p. 103) APhA supports CMS s plan to implement the revised National Committee for Quality Assurance ( NCQA ) measure on medication reconciliation post discharge. By expanding the denominator to include all MA beneficiaries, and by expanding the age range to 18 years of age and above, patients who are disabled or live with ESRD or Lou Gehrig s Disease ( ALS ) can also benefit from important medication reconciliation services during a care transition. ix. MPF Price Accuracy (p ) APhA supports the potential change to the MPF Price Accuracy measure to include claims filled for near 30-day supplies. With this change, plans will be encouraged to provide beneficiaries with more accurate pricing on common pharmaceuticals with near 30-day supplies, such as 28-day supply bisphosphonate products and hormone replacement therapy agents. x. Care Coordination Measures (p. 106) APhA supports the development, adoption, and implementation of care coordination measures and applauds CMS for its efforts to measure plan coordination approaches. We agree with CMS that 5-star plans perform well on Star Ratings measures because they understand how to effectively coordinate care for their enrollees. APhA is actively involved in PQA s measurement development process and other initiatives to better coordinate care during care transitions and shares CMS s interest in identifying mechanisms to measure effective care coordination processes and the effectiveness, timeliness, and clinical relevance of electronic information exchange during care transitions. APhA also supports CMS s plan to monitor measures developed by PQA or NCQA that could be added to the Star Ratings program. xi. Asthma Measure Suite (p ) APhA supports the testing of three asthma measures to evaluate the effects of expanding the measures to include adults 65 and older. APhA believes that by expanding these measures, plans will be encouraged to provide MTM services for older adults who take asthma medications. Taking asthma medication appropriately is challenging. Most asthma patients need to understand how to use medical devices such as nebulizers, which require a multistep process for dosing. Additionally, asthma therapy often includes a rescue inhaler that must be properly

4 APhA Comments to CMS re: CY 2016 Call Letter Page 4 of 8 handled and administered in order to work effectively. Asthma patients are required to have a requisite level of memory, comprehension, and dexterity to adhere to an asthma medication regimen. Testing the three NCQA measures in the elderly population will offer important insight into how to improve asthma treatments and outcomes for the elderly population. xii. Statin Therapy (p. 108) APhA recognizes PQA s November 2014 endorsement of the Statin Use in Persons with Diabetes measure, and we support continued testing of this measure by CMS, as well as consideration of the measure for inclusion in future Part D Star Ratings. xiii. High Risk Medication (HRM) (p. 108) The American Geriatric Society ( AGS ) is reviewing and considering revisions to the Beers criteria. If the timing aligns so that any AGS changes can be incorporated into the HRM measure by PQA and endorsed by the PQA membership prior to the 2016 formulary and bid deadlines, then APhA will support the CMS proposal to consider adoption of the updated measure for the 2018 Star Ratings using 2016 data. B. Drug Utilization Review i. Opioid Overutilization (p. 108) APhA recognizes the importance of developing and implementing programs to address areas of concern such as the overuse of opioids. However, we believe that implementation of measures to monitor opioid utilization to prevent opioid abuse and misuse should occur only after careful study and should be balanced with potential downstream effects on legitimate patient access. For these reasons, we support CMS s decision not to consider opioid overutilization measures for Star Ratings at this time. We also encourage CMS to include pharmacists who provide care to patients taking opioid products as part of the decision-making process. ii. Improving Drug Utilization Review Controls in Medicare Part D (p ) and Improved Drug Utilization Controls for Other Drug Classes (p. 147) APhA was pleased to see CMS s data regarding the decrease in opioid overutilization in Part D plans. We have long been strongly supportive of programs that effectively target and deter prescription drug abuse and misuse provided these programs are narrowly tailored and carefully structured to ensure that legitimate patient access to medications is not compromised. Expansion of the Part D overutilization policy to other therapeutic drug categories beyond opioids should be considered carefully and any new policies should be developed based on scientific evidence so as not to establish arbitrary restrictions and unnecessarily restrict patient access, which could negatively impact patient care. APhA strongly urges CMS to include pharmacists in its utilization control efforts, particularly pharmacists practicing in the therapeutic area(s) under consideration.

5 APhA Comments to CMS re: CY 2016 Call Letter Page 5 of 8 C. Medication Therapy Management (MTM): Annual MTM Eligibility Cost Threshold (p. 148) APhA appreciates CMS s continued support for MTM programs, which improve medicationrelated and overall health outcomes. Studies indicate that for every $1 spent on MTM services, anywhere from $4 up to $12 is saved in addition to cost savings, patients also realize significant improvements in key health measures. Despite clear evidence supporting the value of pharmacist-led MTM services, these programs continue to be significantly underutilized. We strongly encourage CMS to revisit the cost threshold for CY 2016 the current $3,138 threshold excludes many beneficiaries with complex conditions, but smaller drug spends, who could benefit from MTM services. APhA appreciates CMS s ongoing efforts to expand MTM uptake and we hope CMS will continue to work collaboratively with pharmacists, plans, and beneficiaries to improve and streamline MTM eligibility criteria (including the number of medications and chronic conditions) in order to maximize the services benefits to both patients and the larger health care system. II. Provider Networks and Patient Access A. Preferred Cost Sharing Access (p ) APhA strongly supports CMS s commitment to providing patients with access to both affordable medication and the clear, accurate information regarding plans benefits that beneficiaries need to make informed plan selections. APhA, like CMS, advocates for better transparency and supports the concept of plans offering patients access to preferred cost sharing pharmacies ( PCSPs ), which have the potential to increase patient access to affordable medications. In the Call Letter, CMS proposes to supply beneficiaries with information regarding PCSP access levels for each plan offering a preferred cost sharing benefit structure. APhA agrees that providing this information will assist beneficiaries in making informed choices regarding plan selection. The Call Letter does not provide details regarding how PCSP access information will be communicated to beneficiaries, but we suggest that rather than simply providing data on access levels, CMS develop interactive tools for beneficiaries that provide an individualized picture of access based on a specific plan choice (e.g., a website where beneficiaries can input their zip code and view nearby pharmacies that offer a plan s cost sharing levels). We believe this reform is a valuable step in ensuring beneficiary access. We are pleased that CMS will be actively monitoring actual beneficiary access to Part D benefits, including PCSPs, but we encourage CMS to evaluate options to further enhance beneficiary access and choice. CMS s analysis indicates that fewer than half (46%) of plans met the convenient access standards in urban areas. As a result, APhA remains concerned that current plan networks offer inadequate access to PCSPs. While CMS s proposed reforms will certainly offer beneficiaries more information to make informed choices, we believe that if additional pharmacies are offered the opportunity to participate in Part D plans, patients will have increased access to benefits and services, which may result in improved medication adherence and patient outcomes. Thus, APhA continues to advocate for the imposition of a requirement that Part D plans contract with any pharmacy willing to accept their contractual terms and conditions. We believe that patients would further benefit if certain network adequacy standards were introduced. APhA supports network adequacy standards that recognize and include pharmacists as essential providers. In contracting with community pharmacies, plans

6 APhA Comments to CMS re: CY 2016 Call Letter Page 6 of 8 create opportunities for patients to interact with providers in a way that improves outcomes while controlling costs. Finally, while the Call Letter does not address the direct and indirect remuneration rate ( DIR ) for pharmacies participating Part D plans, APhA would like to take this opportunity to advise CMS that a number of our members are encountering increases in DIR that further threaten patient access. In many cases, the increases in percentage fees for brand medications result in the pharmacy returning more money to the plan than the pharmacy receives in actual reimbursement for the medication. Pharmacies are seeing similar negative reimbursement for generics medications as well. We encourage CMS to work with plans to set reasonable thresholds for DIR fees so as not to limit pharmacy participation in Part D plan networks, which could negatively impact patient access. Pharmacies simply do not have the margins to subsidize medications and despite a firm commitment to patient access, the financial realities associated with very high DIR may force many pharmacies to withdraw from networks, further constricting service accessibility in certain areas. B. Value-Based Payment Models (p ) In the Call Letter, CMS notes that it will be reaching out to and having conversations with MA organizations regarding how they are using physician incentive payments (e.g. payments based on quality of care, patient satisfaction) and value-based contracting of provider services to achieve these goals. APhA considers patient-centered, coordinated care to be the gold standard. Thus, we support the development of accountable care organizations ( ACOs ) and other integrated care delivery models that improve outcomes and contain costs. As these models become the norm, it is imperative that clinicians do not encounter regulatory or administrative barriers to participation. Pharmacists are the medication experts of the health care team, and without their participation, ACOs are unlikely to reach their cost and quality goals. Pharmacists currently face barriers to full participation in ACOs, including a lack of provider status (pharmacists are not specifically listed in the statutory definition of ACO Professionals ), limited access to the electronic health record technology (or health information technology subsidies) and health information exchange capabilities necessary to fully engage and exchange information with other clinicians, and payment mechanisms that are insufficient to sustain pharmacist services in ACOs. We encourage CMS to include pharmacists with other health care providers in discussions regarding value-based payment and integrated models of care and to continue to work to address and remove these barriers to participation. We look forward to working with CMS and other stakeholders to find innovative solutions to full and effective care coordination across the entire spectrum of providers and the health system as a whole. III. Drug Pricing and Delivery A. Tier Labeling and Composition; Benefit Review (p ) APhA applauds CMS for addressing the ongoing issues beneficiaries face in determining how a plan s cost sharing requirements will be applied to their medications. CMS s proposals to merge generics into a single tier, with the option of having a Preferred Generics tier, and to require that tier labeling be representative of the actual drugs included within each tier will help beneficiaries better understand the real out-of-pocket costs of their generic medications. Unfortunately, recently, pharmacists and patients have experienced large increases in the cost of generics in the marketplace. These price spikes negatively impact patient access (and, in some

7 APhA Comments to CMS re: CY 2016 Call Letter Page 7 of 8 cases, patient adherence) and APhA appreciates any steps that CMS can take to increase transparency regarding generic pricing and out-of-pocket cost to patients. Additionally, APhA commends CMS for emphasizing the importance of the adult immunization benefit. Offering full coverage of vaccines with very low or no beneficiary costsharing requirement will incentivize many beneficiaries to stay up-to-date with their immunizations. Immunizations are vital to public health, and higher rates of adult immunization will improve patient health while reducing health costs associated with preventable conditions. Pharmacists are important members of the immunization neighborhood and improve patient access to vaccinations recommended by the Centers for Disease Control and Prevention s ( CDC s ) Advisory Committee on Immunization Practices ( ACIP ). Therefore, CMS should encourage plans to maximize the inclusion of pharmacists as in-network clinicians providing vaccines in accordance with the National Vaccine Advisory Committee ( NVAC ) Adult Immunization Standards and as authorized under state practice acts. B. Maximum Allowable Cost (MAC) Pricing (p. 156) APhA appreciates CMS s clarification to plans that MAC pricing data must be submitted to pharmacies in a usable format. Requiring plans to submit pricing data in an organized, accessible fashion will allow pharmacies to utilize the data effectively without having to dedicate scarce human and financial resources to organizing it. C. Mail Order and Changes to Applying for Exceptions to the Auto-Ship Policy (p ) APhA thanks CMS for considering beneficiary choice in addition to beneficiary access when developing Part D policy. In particular, we were pleased that CMS restated its requirement that plans not offer lower cost sharing on mail order to incentivize the use of mail order, which for some beneficiaries can effectively restrict their choice in pharmacies (p. 151). Allowing plans to automatically auto-ship new prescriptions without requesting a CMS exemption and/or without explicit beneficiary consent raises concerns. APhA believes that it should be the patient s choice regarding from which pharmacy, and through what delivery mechanism, prescriptions are received. Further, we have heard from members that many beneficiaries do not fully understand opt-out procedures (e.g., that they can opt-out for one medication but continue to receive others via auto-ship). APhA is extremely supportive of identifying ways to provide convenient, costeffective and quality care to patients, and in identifying these methods, we strongly encourage CMS to also incorporate beneficiary choice. Thank you for the opportunity to provide comments on the Call Letter. We support CMS s efforts to continue to improve the Medicare Part D program and look forward to continuing to work with CMS to reach that goal. If you have any questions or require additional information, please contact Jillanne Schulte, JD, Director of Regulatory Affairs, at jschulte@aphanet.org or by phone at (202) Sincerely, Thomas E. Menighan, BSPharm, MBA, ScD (Hon), FAPhA Executive Vice President and CEO

8 APhA Comments to CMS re: CY 2016 Call Letter Page 8 of 8 cc: Stacie S. Maass, RPh, JD, Senior Vice President, Pharmacy Practice and Government Affairs