December 12, [Submitted online at:

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Centers for Medicare and Medicaid Services Department of Health and Human Services Attention: CMS-4157-P Room C4-26-05 7500 Security Boulevard Baltimore, MD 21244-1850 [Submitted online at: www.

1 Centers for Medicare and Medicaid Services Department of Health and Human Services Attention: CMS-4157-P Room C Security Boulevard Baltimore, MD [Submitted online at: Re: Docket No. CMS-4157-P. Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2013 and Other Proposed Changes Dear Sir/Madam: The American Pharmacists Association (APhA) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) proposed rule, Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2013 and Other Proposed Changes; Considering Changes to the Conditions of Participation for Long Term Care Facilities, published October 11, 2011 (76 FR 63018). APhA, founded in 1852 as the American Pharmaceutical Association, 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, managed care organizations, hospice settings and the uniformed services. Our comments reflect the views of pharmacists practicing across the spectrum of health and patient care settings. APhA appreciates the efforts of CMS to improve the Medicare Advantage (MA) program (Part C) and Prescription drug benefit program (Part D) regulations. We view the proposed rule as a positive step towards reaching this goal. In general, we support the overall direction of the proposed rule and believe that it would generally help to strengthen the Medicare Part C and D programs. APhA s comments will focus on the changes CMS outlined in the preamble concerning requiring long-term care (LTC) consultant pharmacists to be independent from LTC pharmacies and drug manufacturers and distributors. We support the concept but offer recommendations to CMS to consider for improving the proposal. In addition, our comments focus on the proposed provisions to implement expanding Part D drug coverage, improving program efficiency for patients and providers, raising quality standards for plans, expanding benefits for dual eligible patients, increasing flexibility in Part D prescriptions, and clarifying program requirements.

2 Revisions Considered for Long Term Care Consultant Pharmacists Independence of LTC Consultant Pharmacists ( ; p ) APhA Supports an Independent Payment Model Concept for LTC Consultant Pharmacists APhA supports the concept of consultant pharmacists working in an independent capacity to receive payment for patient care services separate from those services provided for the dispensing/delivery of drug products. APhA believes that the independent model concept is applicable to other pharmacist services provided to Medicare patients. For example, CMS should consider such an independent pharmacist model as one option to further utilize and engage community pharmacists as providers of Medicare Part D medication therapy management (MTM) services for targeted beneficiaries to improve patient care and decrease costs. Such an independent payment model could: o Provide a pathway and model for pharmacists to develop business arrangements/contracts and payment methods with Part D plans to provide Part D MTM services for eligible patients without being tied to a single physical pharmacy location. o Further advance opportunities for pharmacists to subcontract with pharmacies to provide MTM services for Part D beneficiaries in a local community thereby opening up MTM to more patients who need it. o Improve opportunities and payment methodologies for pharmacists to participate in integrated patient care models, transition of care programs, accountable care organizations, medical homes, and other evolving patient-centered care processes that utilize all members of the health care team. Specific to the proposal CMS is considering, APhA supports actions to clarify that the delivery of patient care and medication management services provided by consultant pharmacists also be independent from business arrangements that pharmacy benefit managers (PBMs) or manufacturers may have with a LTC dispensing pharmacy. o In such a situation, we would appreciate clarification on how this would apply to Medicare and Medicaid formularies. APhA Concerns and Recommendations While APhA appreciates that CMS has issues with how existing consultant pharmacists relationships with facilities/pharmacies may be perceived, we are concerned with the manner in which the long established and valuable practice of consultant pharmacy is characterized in the notice. o APhA recommends CMS recognize and differentiate traditional and responsible consultant pharmacist services that have been and continue to be provided to patients located in LTC, assisted living, and nursing home facilities from the rogue activities described in the notice. APhA is concerned with the potential impact the proposed changes could have on the current work provided by consultant pharmacists. We are concerned that if implemented as currently drafted and too quickly, the proposed changes could inadvertently result in impending 2

3 consultant pharmacists ability to provide critical patient care services to Medicare patient in such facilities. o APhA recommends that CMS consider the need for sufficient time to evaluate, implement, and phase-in any new independent business arrangements that may be required for consultant pharmacists in the future. APhA is concerned that the requirements as proposed could significantly and negatively impact rural and underserved urban LTC facilities that often have only one pharmacist that is prepared to provide both consultant pharmacist services and product dispensing/delivery services. For example, in many small communities the pharmacist dispenses medications to community patients, mails prescriptions to more rural patients, provides medications, staffing and consulting to the local hospital, and often provides medications and consulting to local nursing homes. Such locations contract with this pharmacist and may have challenges complying with new requirements because of a very limited number of pharmacists in a community and/or no alternative pharmacy to utilize. o We recommend that CMS consider ways to address such challenges when practice location, local populations, and availability of pharmacists may limit the viability of separating an independent consultant pharmacist from the local pharmacy dispensing service. o We also recommend that CMS consider using an existing exception processes or allowing application for waivers when certain demographics may make it impossible to comply with the proposed policy change as CMS continues to discuss utilization of an independent consultant pharmacist model. APhA Recommendation for a Demonstration Project Due to the potential impact of the proposed changes to the practice of LTC consultant pharmacists services for LTC patients, APhA recommends that CMS consider starting with a demonstration program. Limiting implementation to a demonstration program would allow CMS, LTC facilities, consultant pharmacists, and others in the profession of pharmacy to learn from a small scale rollout and consider best practices for further implementation. o We recommend beginning with a demonstration project as this approach would enable CMS and stakeholders to test, in real time and on a limited scale, necessary logistics and administrative requirements to ensure a successful nationwide implementation in the future. o As part of a demonstration project, we encourage CMS to address necessary billing systems that could be utilized through this new approach to providing LTC consultant pharmacist services. As it stands, existing billing systems would need to be modified to support pharmacists working in LTC facilities in an independent capacity to receive payment for their patient care services. o Within the parameters of the demonstration project, CMS is encouraged to modify current requirements to allow LTC consultant pharmacists to seek reimbursement from Part B directly. Doing so would augment and support recommendations for CMS to develop administrative guidance/best practices for implementing this proposed new approach to LTC consultant pharmacists services for LTC patients. 3

4 Medicare Coverage Gap Discount Program Provision of Applicable Discounts on Applicable Drugs for Applicable Beneficiaries: Pharmacy Prompt Payment ( ; p ) APhA supports CMS efforts to ensure pharmacies are reimbursed in timely manner as required by Section 1860D 14A(c)(1)(A)(iv) of the Social Security Act. APhA supports the proposed rule s implementation of this section which specifies that Part D sponsors must reimburse a network pharmacy the amount of the appropriate discount no later than the designated number of calendar days after the date of dispensing an applicable drug. APhA appreciates CMS effort to require prompt payment of pharmacy claims within the Medicare prescription drug benefit as pharmacists have played an integral role in ensuring the success of the Medicare Part D prescription drug benefit program. Expanding Part D Drug Coverage Inclusion of Benzodiazepines and Barbiturates as Part D Covered Drugs ( ; p ) APhA supports revising the definition of a Part D drug in , as required through the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA; Public Law ), to include barbiturates and benzodiazepines (when used to treat epilepsy, cancer, or a chronic mental health disorder) that are dispensed on or after January 1, APhA supports this and future such efforts to ensure patients have appropriate coverage to receive the appropriate medication for their health condition(s). Improving Program Efficiency for Patients and Providers Who May File Part D Appeals with the Independent Review Entity ( and ; p ) APhA supports efforts to improve Medicare program efficiencies and efforts to reduce administrative burdens. We support the proposed language allowing authorizing physicians and other prescribers to request Independent Review Entity (IRE) reconsiderations on behalf of enrollees. We support this modification which would allow prescribers to assist their patients in the appeals process without taking on the added responsibilities related to being an appointed representative. We recommend Medicare ensure that Medicare s Web site, Medicare and You Handbook, and communications from Part D plans to patients specifically include such information to help increase patient awareness of such medical service or drug coverage appeal options. Raising Quality Standards for Plans Requiring MA Plans To Issue ID Cards ( ; p ) APhA strongly supports the proposed rule s language requiring that identification cards be issued to enrollees. While we understand that many MA organizations issue such cards to enrollees, information on the cards is inconsistent and can be confusing to patients and 4

5 pharmacists trying to process prescription claims. We support CMS efforts to establish requirements for the MA member ID card to ensure that needed information is readily available to enrollees and support CMS clearly indicating what information ID cards must contain as described below in the proposal: For an MA PPO or PPFS plan, a statement that Medicare Limiting Charges apply; An address for the plan s website; A customer service number; and The individual identification number for each enrollee, to clearly identify that he or she is a member of the plan. We further support the proposed rule s effort to safeguard enrollees through prohibiting plan sponsors from disclosing social security numbers or health insurance claim numbers on the member ID cards. We recommend that CMS reference such safeguards in its communication to patients through the Medicare Web site and the Medicare and You Handbook. In addition, we recommend that CMS provide information to pharmacists on the standardization, consistencies, and use of information on a plan ID cards to help improve efficiencies in prescription claims processing based on such information easily identified on a patient s member ID card. Increase Flexibility in Part D Prescriptions Establishment and Application of Daily Cost-Sharing Rate as Part of Drug Utilization Management and Fraud, Abuse and Waste Control Program ( and ; p ) APhA supports CMS efforts to reduce medication waste in any setting. Starting in 2013, this proposed rule would require Part D sponsors to provide their enrollees access to a daily prorated cost-sharing rate for prescriptions dispensed by a network pharmacy for less than a 30-day supply of certain covered Part D drugs that are for an initial fill of a new medication and meet specified criteria. We feel this approach should help CMS reach its goal of improving options for addressing drug waste while also reducing the amount of unused drugs dispensed to pharmacies Medicare patients. However, we continue to be concerned with the cost of implementation. As we have stated in past comments on this issue, CMS should ensure that pharmacies are fully compensated for the cost to dispense multiple fills of the same prescription order. There are fixed costs associated with filling every prescription regardless of the quantity dispensed. We recommend that CMS closely monitor the implementation of this provision and specifically the actual dispensing costs to pharmacies to ensure that pharmacy dispensing fees are adequately covered. In addition, we strongly recommend that CMS provide administrative and logistical information/instructions to pharmacies on implementing this new program. As drafted, this rule will impact workflow, staffing and related issues within the network pharmacies that fill these prescriptions. 5

6 Clarify Program Requirements MTM: Medication Therapy Management Comprehensive Medication Reviews and Beneficiaries in Long Term Care Settings ( ; p ) APhA supports CMS attempt to improve medication reviews. We recommend that CMS provide further clarification to pharmacists about distinguishing services provided through existing consultant pharmacists activities and drug utilization reviews versus those that are required for targeted LTC patients through Medicare Part D MTM services. As outlined in the proposal, we support revising to require sponsors to offer the annual comprehensive medical review (CMR) to targeted beneficiaries in an LTC facility, but when the beneficiary cannot accept the offer to participate, the pharmacist or other qualified provider can continue to perform the medication review. This new language recognizes that some targeted patients are unable to communicate with the pharmacist. When this provision is adopted, APhA looks forward to working with CMS to educate pharmacists that in these situations pharmacists are encouraged to reach out to the beneficiaries prescriber, caregiver or other authorized individual to take part in the beneficiaries medication review. Access to Covered Part D Drugs Through Use of Standardized Technology and National Provider Identifiers ( ; p ) APhA supports CMS ongoing efforts to standardize Part D prescriber identifier reporting in prescription claims processing. As outlined in the proposed rule, consistent with the Health Insurance Portability and Accountability Act of 1996 (HIPAA; PL ) the rule would, among other things, require prescription drug event records to contain an active and valid individual NPI starting in We concur with the need for this revision and support its implementation as it will improve the existing reporting requirements. We recommend that CMS work with pharmacy organizations and claims processing stakeholders, such as the National Council for Prescription Drug Programs (NCPDP), on implementation of this provision and in helping to increase awareness of future changes. In addition, we recommend that CMS consider best ways to ensure that pharmacies and third party vendors have administrative and logistical information available to help increase awareness and to implement this provision. In conclusion, APhA thanks you for the opportunity to provide comments on this important issue. We look forward to continuing to work with CMS on this issue and in working with CMS to distribute information to our members to help increase awareness of final changes to the Medicare program in If you have any questions or require additional information, please contact Marcie Bough, Senior Director of Government Affairs, at mbough@aphanet.org or by phone at (202) Sincerely, Thomas E. Menighan, BSPharm, MBA, ScD (Hon), FAPhA Executive Vice President and CEO 6

7 TM/mb cc: Brian Gallagher, BSPharm, JD, Senior Vice President, Government Affairs Marcie Bough, PharmD, Senior Director, Government Affairs 7

Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2013 [File Code CMS 1590 P]

Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2013 [File Code CMS 1590 P] Centers for Medicare & Medicaid Services Attention: CMS 1590 P Mail Stop C4 26 05 7500 Security Boulevard Baltimore, MD 21244 1850 [Submitted online at: http://www.regulations.gov] Re: Medicare Program;