March 7, [Submitted electronically to

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1 March 7, 2014 [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) 2015 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2015 Call Letter Dear Sir/Madam: APhA is pleased to submit these comments regarding the CY 2015 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 related to changes to measures for 2015 (at p ), changes to measures (at p. 90), access to preferred cost-sharing (Attachment VI, Section III, p ), and medication therapy management (MTM) (Attachment VI, Section III, p ). We address each provision separately below. I. Changes to Measures for CY 2015 APhA would like to thank CMS for recognizing the value of pharmacists patient care services and pharmacist involvement in impacting many Star Ratings that advance the quality of sponsor plans. Specifically, we are pleased to see updates to measures such as the Annual Flu Vaccine; High Risk Medications; Medication Adherence for Diabetes Medications; Transitions Monitoring; and, Combined MPF Price Accuracy Measures. However, we have some concerns with the weighting for the medication adherence measures for the Star Ratings program.

2 1. CMS Modifying Measures Methodology APhA agrees with CMS that the yearly timeframe should be expanded for patients receiving their flu vaccine. This expansion will increase the numerator value of the measure, and this, coupled with the elimination of the pre-determined 4-star threshold, will incentivize sponsors to promote important beneficiary vaccinations against the often preventable influenza virus. CMS should expect to realize tremendous cost savings associated with decreased influenza-related hospitalizations and drug utilization. We applaud CMS for including the updates to the Pharmacy Quality Alliance (PQA) Medication Adherence for Diabetes measure that adds meglitinides and incretin mimetic agents in the 2015 Star Ratings. With these highly effective diabetes drug classes included in the adherence measure, sponsors will emphasize beneficiary adherence to critically important medications for the effective management and control of diabetes. Complications from longstanding poorly-treated diabetes, such as chronic kidney disease, are devastating for patients and costly outcomes for the Medicare program. 2. Measures Remaining on the Display Page for 2015 APhA supports the Medication Therapy Management (MTM) Program Completion Rate for Comprehensive Medication Reviews (CMR) measure as a mechanism of evaluating uptake of the MTM benefit by beneficiaries. While we would like to see the CMR measure moved to the Star Ratings program as soon as possible, we understand CMS rationale for deferring addition of this measure to the Star Ratings program until 2016 or 2017, after the proposed changes to the MTM benefit have been implemented. APhA strongly supports the proposed changes to the MTM benefit in CMS proposed rule. The proposed expanded eligibility criteria of two chronic diseases, two Part D medications, and $620 in annual drug spend will allow many more beneficiaries to receive this important benefit and will also standardize many aspects of the MTM benefit that will facilitate more meaningful measurement of processes and outcomes, including the CMR completion rate. APhA supports delaying transition of the CMR completion rate to the Star Ratings program until the new changes are in effect. 3. Measures Being Considered for Introduction on the 2015 Display Page APhA applauds CMS for identifying gaps in the continuity of patient care. Often, patients experience gaps in drug therapy during plan transitions and the pharmacist, concerned that the patient may go without their life-saving medications, advances medications to the patient with only a hope of being reimbursed. We are pleased to see measures related to transition monitoring that ensure sponsors are adequately administering formulary transition requirements by providing enrollees with a one-time temporary supply of requested non-formulary drugs to allow time for the enrollees to switch to alternative therapies. We also commend CMS for recognizing the importance of price transparency. The new display measure, Plan Submitted Higher Prices for Display on MPF, evaluates when a sponsor s posted price for a Part D drug is higher than the actual price charged at the POS. This measure, along with its counterpart, the MPF Price Accuracy Star Rating measure, which measures when a sponsor s posted price for a Part D drug is lower than the actual price charged at the point of sale (POS), is a leap forward in sponsor drug benefit transparency. Star Ratings in 2

3 this category will increase sponsor competition which will lead to significant declines in drug costs to CMS. 4. Changes to Measure Specifications on the 2015 Display Page APhA supports the proposed changes to the Drug-Drug Interactions and Diabetes Medication Dosing measures, which reflect recent updates made to PQA measures. II. Measurement Concepts APhA strongly supports CMS interest in the development of new measures in the care coordination, care transitions, and patient reported outcomes areas. Measures of care coordination focusing on how well providers and organizations coordinate services and measures of care transitions from one healthcare setting to another (e.g. care transitions following hospital discharge) are important areas of focus nationally in an effort to improve patient health and prevent adverse events. Likewise, measures of patient-reported outcomes are important to understanding patients experiences with their providers and the health care system. We encourage CMS to work with PQA in efforts to create meaningful measures to address these important areas-apha is very interested in being involved in this work as well. III. Weighted Adherence Measures APhA is concerned with the proposal to reduce the weight of the adherence measures to 1.5x, as access measures, from the current 3x as outcomes measures. We recognize that adherence measures are not true outcomes measures, but believe that these measures contribute to positive health outcomes. Reducing the weighting of the adherence measures would diminish the incentives for health plans to develop adherence interventions. While we recognize the limitations of claimsbased measures, we disagree that the adherence measures do not point to outcomes. Improved adherence is positively associated with clinical outcomes as indicated by the Agency for Healthcare Research and Quality (AHRQ) and numerous peer-reviewed studies. The adherence measures currently included in the Star Ratings were developed with broad stakeholder consensus and are the best measures currently available to address these issues. We believe CMS should keep the weights at 3x and collaborate with measure development organizations like the Pharmacy Quality Alliance (PQA) to develop more robust outcomes measures for the Star Ratings programs. IV. Access to Preferred Cost-Sharing APhA strongly supports CMS s commitment to promoting beneficiary access through clear cost-sharing requirements. In particular, CMS s decision to study beneficiary access to preferred cost-sharing should help identify specific geographical areas where beneficiaries may have limited access to pharmacy services. We believe that as more pharmacies are offered the opportunity to participate in plans, patients will have increased access to services, which may result in increased medication adherence and improved patient outcomes. APhA strongly supports the requirement that a plan contract with any pharmacy willing to accept its cost-sharing requirements. However, it is important to note that in order to ensure wide provider participation, plans should set cost-sharing levels at rates that are sufficient to 3

4 cover providers costs. 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 pharmacies, plans create opportunities for patients to interact with providers in a way that improves outcomes while controlling costs. V. Medication Therapy Management APhA would again like to take this opportunity to express our thanks to CMS for recognizing the important role pharmacist-led MTM plays in improving patient outcomes. We have several comments on the MTM section of the Call Letter (p ). Audit Standards: CMS notes that it is considering new audit performance requirements for MTM and that these requirements may impact Star Ratings. While APhA is supportive of methods to evaluate MTM programs, the Call Letter provides no detail on these new requirements. We respectfully request that CMS include more specific information on the audit requirements in the Final Call Letter or indicate when more specific guidance may become available. HIT Standards: APhA has long supported the development and implementation of health information technology (HIT) standards for MTM services. Pharmacists work with MTM systems daily and are uniquely situated to provide essential feedback on how to incorporate MTM documentation practices efficiently and seamlessly into existing workflows. APhA strongly supports consensus on standard definitions for terms such as MTM, CMR, and drug therapy recommendations and resolutions for service delivery and performance measurements and will continue to work with other stakeholders as well as CMS to reach consensus on standard definitions. Opioid Management: APhA commends CMS for recognizing the complexity of managing chronic pain and the need for pharmacist-led interventions. However, APhA suggests that CMS require, rather than just encourage, sponsors to offer services to beneficiaries for the treatment of noncancer pain management. The Institute of Medicine (IOM) has documented that there are 100 million Americans living with chronic pain -a significant portion of whom are Medicare beneficiaries. Often, patients living with chronic pain never receive MTM services because noncancer chronic pain is currently not one of the recognized core chronic diseases for MTM eligibility. APhA is concerned that if sponsors are not required to offer MTM services to this specific group of beneficiaries, then their pain management treatment will remain suboptimal. 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 [email protected] or by phone at (202) Sincerely, 4

5 Thomas E. Menighan, BSPharm, MBA, ScD (Hon), FAPhA Executive Vice President and CEO cc: Stacie S. Maass, RPh, JD, Senior Vice President, Pharmacy Practice and Government Affairs 5