Re: Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2012 and Other Proposed Changes

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1 January 11, 2011 Submitted via: Dr. Donald M. Berwick, Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services 200 Independence Avenue, SW Washington, DC Attn: CMS 4144 P Re: Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2012 and Other Proposed Changes Dear Administrator Berwick: The American Society of Consultant Pharmacists (ASCP) is pleased to provide comments to the Centers for Medicare and Medicaid Services (CMS) regarding the proposed rule, Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2012 and Other Proposed Changes, published in the November 22, 2010 Federal Register. ASCP is the international professional society of consultant pharmacists whose mission is to promote the appropriate, safe and effective use of medications in the elderly. Our 7,000 members provide long term care (LTC) and consultant pharmacist services to seniors and individuals living with chronic illness wherever they reside. ASCP members serve patients residing in a variety of environments, including nursing facilities, sub acute care and assisted living facilities, psychiatric hospitals, hospice programs, and home and community based care. ASCP has a long history of advocating for the medical best interests of people who reside in longterm care facilities (LTCFs) and those enrolled in hospice programs. ASCP is pleased to provide comments on the following proposed changes to the Medicare Advantage and Medicare Prescription Drug Benefit programs: 1. Appropriate Dispensing of Prescription Drugs in Long Term Care Facilities Under PDPs and MA PD Plans ( )

2 2. Improvements to Medication Therapy Management Programs ( ) ASCP is pleased to assist CMS in its goal to implement certain provisions of the Affordable Care Act (ACA), improve upon the Medicare Prescription Drug Benefit Program, and to strengthen beneficiary protections. Please direct any technical questions to Lynne Batshon, Director of Policy & Advocacy, at lbatshon@ascp.com or x141. Thank you for the opportunity to provide feedback. Sincerely, John Feather, Ph.D., CAE Executive Director, ASCP Albert Barber, PharmD, CGP, FASCP President, ASCP 2

3 1. Appropriate Dispensing of Prescription Drugs in Long Term Care Facilities Under PDPs and MA PD Plans ( ) Section 3310 of the Affordable Care Act (ACA) intends to reduce both financial and physical pharmaceutical waste associated with dispensing 30 day fills to Medicare Part D beneficiaries residing in LTCFs. ASCP supports any efforts to meaningfully reduce waste in an effort to reduce costs associated with Medicare administration, to reduce the potential for impact on the environment, and to reduce the potential for diversion. However implementation of the proposed 7 days or less dispensing method for Part D covered brand prescription medications would represent a major shift in LTCF medication handling procedures, and business operations models for LTC pharmacies that will make or break their ability to operate. While we support CMS s long term goals for cost savings for the Part D program, ASCP has serious concerns over the LTC pharmacy industry s ability to adjust in the short term, and with the mandated timeline outlined in the proposed regulation. ASCP also has concerns about the added complexity of handling multiple additional refills of each medication at a LTCF and the subsequent potential for increased medication errors. Finally, ASCP has concerns over the pressure on the existing labor force charged with carrying out these new requirements. Proposal to initially limit the requirement to brand name drugs CMS proposes to begin the transition to 7 days or less dispensing by only mandating the regulations for Part D covered brand name drugs with the option to apply the new regulations to generic drugs. ASCP agrees with CMS s assertion (as provided by industry sources) that as much as 80% of medication waste and the costs associated with it in LTC come from brand name drugs, which represents only 20% of the medications dispensed. However in consideration of the capital investments needed to transition pharmacy business models that service primarily LTCFs and currently operate primarily based upon a 30 day fill cycle, most LTC pharmacies will not realize any benefits that could arise from applying the 7 days or less fill cycle requirement on only a fraction of the medications dispensed. When evaluating new investments that must be considered in order to accommodate an all LTC operation and regular uniform dispensing of medications in 7 days or less dispensing fill cycles, pharmacies must consider: Costs associated with purchasing new equipment, such as automated dispensing systems, packaging equipment, and computer software; Costs associated with hiring additional pharmacists and pharmacy technicians, as would be required to accommodate an ongoing manual 7 days or less dispensing fill cycle process; Providing an expanded training program to educate new and existing staff on the new process, and to maintain training for staff with high turnover rates; 3

4 Costs associated with reprogramming software in existing equipment and pharmacy management systems; Costs associated with the development of new policies and procedures, and the time needed to change out and implement a new system (typically a 3 6 month process); Expectations for coverage of operational, staff and retooling costs through dispensing fees paid by Part D Plan sponsors. Many ASCP members have indicated their estimated upfront capital investment for implementing 7 days or less dispensing fill cycles at an LTC pharmacy is anywhere from the tens of thousands to the hundreds of thousands of dollars depending on the size of the pharmacy, the volume of medications processed, and the number of LTCFs serviced. Given CMS s mandate to implement the new regulation beginning January 1, 2012, LTC pharmacies will have less than a year from the date of the finalization of the rule to finalize and implement major operational decisions and to make all of the financial investments needed to be operational by that date. For many LTC pharmacies, the operational retooling needed to accommodate 7 days or less dispensing for only part of the medications dispensed is the same as for accommodating 7 days or less dispensing for all of the medications dispensed. ASCP believes the application of 7 days or less dispensing to brand only Part D covered drugs does not represent a reasonable opportunity for most LTC pharmacies to transition. Pharmacies that process and dispense a small volume of Part D covered drugs supplied to LTCFs relative to the rest of their operation may see an advantage to this transitional approach for a start date of January 1, However many of our members initial investment will be the same regardless of whether the mandate is for part or all Part D covered drugs, and therefore no cost benefit can be realized by starting with only a portion of the total medications dispensed. Further, large LTC pharmacy operations looking to retool in time for the January 1, 2012 deadline may find themselves operating multiple dispensing systems at LTCFs at the time of implementation. This scenario has the potential to lead to errors in the management of dispensing systems from both the pharmacy and LTCF staffs. For example, the potential for inappropriate reordering of medications on a timely basis could lead to missed doses and delays in getting medications to patients. Although CMS has indicated that it reasonably expect[s] dispensing fees [to] be adjusted based on the proposed requirements under this provision, CMS has provided limited assurance that dispensing fees will reasonably capture all additional expenses related to complying with 7 days or less dispensing requirements. ASCP supports CMS s expanded definition of dispensing fee under to include acquisition, maintenance, and technology costs accrued by the pharmacy. However this definition does not take into account the breadth of these capital expenses and the variables involved in each business relationship, nor does 4

5 it compel Part D Plans to ensure that reasonable care is taken to reasonably cover expenses. ASCP believes more time is needed for business negotiations between pharmacies and Part D Plans to ensure dispensing fees capable of supporting 7 days or less dispensing can be determined and established. ASCP believes that giving the LTC pharmacy industry a year or less to finalize and implement capital investment decisions is unreasonable and will not benefit the long term goal of reducing pharmaceutical waste in a meaningful way. Further, more time is needed to evaluate options to ensure the long term goal of waste reduction is attainable and sustainable for the LTC industry. A rapid change in systems could lead to adverse patient events, which will negate any financial or environmental benefit to be gained through 7 days or less dispensing. Therefore ASCP respectfully requests CMS revise the implementation deadline from January 1, 2012 to January 1, ASCP supports CMS s goal for achieving over $2 billion in cost savings for the Part D program by However CMS should consider a delay in implementation for the following reasons: LTC pharmacies will have a more appropriate time period in which to make clear capital investment decisions that are appropriate for each unique business and circumstance. The risk for medication errors, delays in patient access to medications, and related adverse events associated with making a rapid transition to new systems will be limited. Pharmacy dispensing transactions are recorded and tracked through electronic transaction standards, created primarily by the National Council of Prescription Drug Programs (NCPDP). ASCP believes CMS has not provided NCPDP with enough time to develop the transaction standards needed to accommodate all aspects of 7 days or less dispensing. Further, we disagree with CMS s assertion that existing transaction standards can accommodate all aspects of the proposed new requirements for appropriate dispensing of prescription drugs in LTCFs. Hasty business decisions made under pressure will put an otherwise stable pharmacy business at unnecessary risk for failure. Once capital business decisions and investments are finalized, they cannot be reversed. Making the wrong kind of business decision under pressure could result in the loss of pharmacy businesses and a decrease in the number of provider pharmacies available to service LTCFs. There may not be enough supply of new systems equipment (including but not limited to automated dispensing systems, medication carts) from manufacturers to install, implement and train staff in the time frame mandated by CMS. Types of dosage forms and drugs that should be excluded from the requirements 5

6 ASCP supports the application of an exemption for the list of drug dosage forms proposed on page of the Federal Register notice. However ASCP proposes the addition of controlled substances to the proposed list of exempted drug classes. Each state has established regulatory requirements for recordkeeping, dispensing and inventory maintenance for controlled drugs, which are different and more cumbersome than for non controlled medications. It is a recognized standard practice for LTCFs and provider pharmacies to adhere to these regulations, which include requirements for staff to keep separate logs documenting the delivery, storage, packaging and administration of controlled medications. Further, the number of transactions for handling controlled medications is limited as much as possible not only to ease the administrative burden, but also to deter opportunities for diversion. For example, each time a dispensed controlled medication is received from the pharmacy at the LTCF, it must be counted separately and entered into a narcotic inventory sheet, which must be initiated, maintained and signed by a designated staff person. A secured delivery process, which differs from the process for other medications, must be in place and must coincide with a special reconciliation process. If this class of drugs was subject to 7 days or less dispensing requirements, the number of these transactions will multiply by four times increasing the volume of paperwork, staff time, delays in patient access to medications, and the window of opportunity for diversion. Specific regulations for delivery and handling of controlled medications are determined at the state level. These procedures must be executed for each controlled medication dispensed, delivered and administered. In consideration of the staff time, administrative burden, risk for patient access delays, and risk for diversion that could occur when carrying out these requirements, ASCP respectfully requests the addition of controlled medications to the proposed list of drug dosage forms exempt from the 7 days or less requirement. Return and Reuse as a solution for pharmaceutical waste reduction ASCP shares CMS s concerns with the application and limitations of return for credit and reuse of dispensed medications. However some ASCP members located in states where return for credit and reuse is allowed by state law have indicated that the 7 days or less mandate will disrupt current systems that already limit the generation of waste. Further, CMS s regulation requires these pharmacies to make substantial capital investments with little return on their investment in the form of further waste reduction. ASCP members in some states have indicated that the application of return for credit and reuse works well within the LTC community. Unused brand drugs are returned to the pharmacy for credit and then restocking. And while there are expenses and fees associated with this process, pharmacists in these states have 6

7 indicated that the operational impact is minimal. Further any unused generic drugs that cannot be credited or restocked at the pharmacy are donated to prescription drug donation programs in states that have such programs. These drug donation programs rely substantially on these donations from LTC and other settings in order to provide needed pharmaceuticals to low income citizens. When these two systems are allowed to operate together, very little pharmaceutical waste for disposal is generated and pharmacy businesses have a demonstrated ability to remain profitable. By requiring such pharmacies to move away from an efficient return for credit and reuse process to the 7 days or less dispensing process, CMS risks mandating a major operational retooling that requires substantial capital investment with limited benefit in the form of reduced waste and cost savings. The length of time needed for pharmacies to realize a return on investment and cost savings from the capital investment needed to implement 7 days or less dispensing is unknown. Risking the stability of pharmacy businesses by forcing them to make investments that may have little to no improvement on waste reduction outcomes is unacceptable. Therefore ASCP respectfully requests CMS consider recognizing as an alternative to the 7 days or less dispensing requirement, allowing the application of return for credit and reuse by pharmacies located in states that permit return for credit and reuse of unused drugs, and in states that utilize drug repository programs. The following states have regulatory frameworks 1 in place that provide for, or already allow pharmacies to accept unused pharmaceuticals for credit and/or return to stock and/or reuse in addition to allowing prescription drug donation programs: Arizona Arkansas California Colorado Connecticut Florida Georgia Idaho Iowa Kansas Louisiana Maryland Michigan Minnesota Montana Nebraska 1 Based on public information available on state government websites. 7

8 New Hampshire Ohio Oregon Tennessee Virginia West Virginia Further, ASCP believes that the Drug Enforcement Administration (DEA) will propose new regulations 2 regarding the disposition of unused controlled medications in long term care, which would allow LTCFs to transfer possession of unused controlled medications generated at a LTCF to a DEA registered entity for proper disposition. If such regulations were to allow LTCFs to transfer unused controlled medications to state drug repository programs, the promulgation of these regulations would further reduce waste for pharmacies and LTCFs in Iowa and in other states with similar drug repository programs. Proposal to require the return of all unused dispensed Part D covered drugs back to the pharmacy and reported to the Part D sponsor ASCP opposes CMS s recommendation to require Part D Sponsors and LTC pharmacies to include in their contractual agreements a requirement to return all unused Part D covered drugs back to the pharmacy. While we understand CMS s desire for Part D Plan sponsors and LTC pharmacies to account for the disposition of all unused pharmaceuticals, ASCP views any requirement to return all unused pharmaceuticals to the pharmacy as arbitrary, as well as financially and operationally burdensome. ASCP recognizes that some LTC pharmacies already accept on behalf of LTCF clients, unused pharmaceuticals that are not controlled substances and are not considered hazardous wastes. And in states where return for credit and reuse is allowed, some unused pharmaceuticals (mostly brand drugs) are returned to the pharmacy. In these cases, the expenses related to the transfer logistics for the unused pharmaceuticals are typically included as part of any contractual service agreements between LTC pharmacies and LTCFs. Pharmacies not already accepting returns will have to raise their fees back to LTCFs to cover the expenses to facilitate the return process. In states where credit and reuse is not allowed, pharmacies will incur additional expenses for proper disposal that would otherwise be incurred by the LTCF. If CMS mandates for all LTC pharmacies the return of all unused dispensed Part D covered drugs regardless of whether they can be restocked or where disposal is required, LTC pharmacies currently not practicing this as part of their existing 2 Procedures for the Surrender of Unwanted Controlled Substances by Ultimate Users; Notice, 75 Fed. Reg (December 22, 2010) Web. Notice of a public meeting January to discuss methods for proper disposal of unused controlled medications. 8

9 service agreements will be forced to take on substantial additional operating costs, which would likely put them at an unfair business disadvantage. Further, certain medications should not be transferred to another location prior to disposal and therefore should not be required to be returned to the dispensing pharmacy. This includes drugs: Determined to be hazardous waste because of their chemical characteristics and because they are contaminated, expired, or otherwise cannot be reused, such as warfarin tablets; Determined to be controlled drugs; Located in a state where return for credit and reuse is prohibited by law; Located in a state where return of any dispensed prescription drugs back to the pharmacy is prohibited by law; Drugs falling into any of these categories should not be transferred to another location prior to disposal and therefore should not be required to be returned to the dispensing pharmacy. In the case of drugs considered hazardous and also waste destined for disposal, federal 3 and local state laws prohibit the transport of these materials between the waste generation site and a different site once the material is deemed waste. Since that determination is likely to be made at the LTCF, transport of hazardous waste drugs back to the LTCF would be illegal. In states where return for credit and reuse is prohibited by law, all drugs, including those that would not otherwise be considered waste, would fall into this category and therefore could not be returned to the dispensing pharmacy. In the case of controlled drugs, current DEA regulations prohibit the transfer of any unused controlled drugs from non registrants to any entities whether registrants or non registrants of DEA. LTCFs and their residents are not DEA registrants and therefore cannot transfer possession of controlled drugs beyond the LTCF site without permission or assistance from local law enforcement or local DEA officials 4. DEA is in the process of proposing and promulgating regulations that will determine how ultimate users of controlled drugs, including residents in LTCFs, may be able to dispose of unwanted controlled drugs as provided through the 3 For example, 40 CFR Part 262 describes standards applicable to generators of hazardous waste. Additionally, 49 CFR Part 173 describes requirements for shipments of hazardous materials, which applies to shipments of hazardous waste. 4 Pharmacist s Manual: An Informational Outline of the Controlled Substances Act. United States Department of Justice, Drug Enforcement Administration, Office of Diversion Control, 2010 Edition, Page 51. Accessed on the web January 11,

10 Secure and Responsible Drug Disposal Act of It is unknown at this time whether those regulations would permit the return of controlled drugs back to the dispensing pharmacy. Additionally, there are several states that prohibit the return of dispensed prescription drugs once they have left the pharmacy. While ASCP s list may not be exhaustive, we have found the following states would not allow the return of already dispensed medications back to the pharmacy 6 : Alabama Hawaii Mississippi New Mexico Further, ASCP asks that CMS clarify whether it intends to apply the return provision to: All prior dispensed drugs from LTCFs; All Part D covered dispensed drugs from LTCFs; All Part D covered dispensed drugs from LTCFs, except those drugs excluded from the 7 days or less dispensing requirement The current language is unclear on CMS s intent. It appears CMS is requiring this provision for the purpose of tracking and recording the disposition of unused dispensed drugs. It is also unclear whether CMS s regulatory authority extends to mandating the return of some or all of the drugs subject to this proposed regulation. If in fact CMS believes that returning unused dispensed drugs back to the pharmacy would enhance the ability to track and record the disposition of these drugs, ASCP asks CMS to amend this language to suggest returns to the pharmacy, where allowed by law, rather than mandating under this regulation. ASCP further recommends CMS provide guidance on information being sought, collected, recorded, and reported for unused pharmaceuticals, and that CMS provide the option for that information be collected and recorded at the LTCF prior to final disposition. Proposal to waive 7 days or less dispensing requirements for particular types of LTC pharmacies 5 Procedures for the Surrender of Unwanted Controlled Substances by Ultimate Users; Notice, 75 Fed. Reg (December 22, 2010) Web. Notice of a public meeting January to discuss methods for proper disposal of unused controlled medications. 6 Based on public information available on state government websites. 10

11 ASCP supports waiving requirements for the mentally retarded and developmentally disabled (ICFMRDD) and institutes for mental disease (IMDs). ASCP further supports waiving the requirements for similar facilities that meet and demonstrate the same criteria outlined in the proposed rule. ASCP supports waiving requirements for LTCFs utilizing Indian Health Service or Tribal facilities. ASCP supports CMS s proposal to allow an independent community pharmacy that is a primary provider of the Part D covered drugs to a LTCF located in a rural community to dispense a 14 day supply through December 31, However ASCP believes the criteria outlined for pharmacies and LTCFs that might qualify for this relief is unclear and possibly too narrow to be useful to a reasonable extent. Many pharmacies and their LTCF clients that do not fit CMS s criteria for an extension currently lack dedicated staff to adequately train and make the necessary changes to convert to 7 days or less dispensing by January 1, Further, ASCP questions whether those facilities that do meet this requirement would benefit in a meaningful way if still required to dispense in 14 day supplies by January 1, As stated earlier in this document, the needed resources and capital investment to convert to a less than 30 day dispensing method is substantial regardless of whether the conversion is to 14 day or 7 day dispensing cycles. ASCP does not believe CMS has provided reasonable parameters for an extension and therefore requests CMS to instead revise the implementation deadline from January 1, 2012 to January 1, 2013 for all stakeholders. Possible industry incentives for early implementation of 7 days or less dispensing in the LTC setting ASCP understands CMS s goal of implementing 7 days or less dispensing in the LTC setting with a goal of achieving over $2 billion in cost savings by If CMS agrees that a delay of one year is necessary in order to ensure the LTC industry is able to make a successful transition to 7 days or less dispensing, ASCP believes CMS would still meet is stated cost savings goal through: Many pharmacies implementation of 7 days or less dispensing on all medications dispensed in LTC beginning January 1, 2013 A financial incentive to beginning January 1, 2012 and end December 31, 2012, for pharmacies to implement 7 days or less dispensing on brand only medications beginning January 1, 2012 ASCP proposes extending a financial incentive of $.01 per dose dispensed through a 7 days or less dispensing system for pharmacies choosing to implement 7 days or less dispensing on January 1, 2012, or one full year before the final regulations would become effective. This incentive would only be made available between January 1, 2012 through December 31, 2012 and would 11

12 apply only to those drugs dispensed through a 7 days or less dispensing system. The revenue generated through the incentive could assist pharmacies with defraying the cost of acquiring and installing new technology and systems that would otherwise present an extreme capital investment challenge. CMS could potentially realize all its projected cost saving or more by implementing such an incentive program while putting less financial burden on the industry. 2. Improvements to Medication Therapy Management Programs ( ) ASCP supports CMS s goal of ensuring that LTCF patients with multiple chronic diseases and taking multiple Part D covered drugs have access to an optimal level of care through medication therapy management (MTM) programs. Medication related changes can have a significantly greater impact on the health status of the frail, elderly LTC beneficiary who has multiple complex comorbidities treated with concomitant medications. Consultant pharmacists, as part of established practice in the LTC setting, provide many aspects of MTM as needed, or as required, in addition to the monthly medication regimen review (MRR). ASCP believes that to ensure LTC patients receive the full MTM benefit afforded to them through Medicare Part D, clarification in support of consultant pharmacist delivered MTM services is needed to delineate between those services being provided as part of the MRR and those services being provided as part of MTM services. Coordination of MTM Programs required by the Medicare Modernization Act (MMA), the CMS State Operations Manual (SOM), and the Affordable Care Act (ACA) Part D beneficiaries residing in LTCFs are entitled to the MTM Program (MTMP) services administered by Part D sponsors and mandated by the MMA. Additionally, residents of LTCFs must receive a monthly MRR as mandated by the SOM. And as stated in the Federal Register notice, Congress provided for specific MTMP improvements as part of the ACA. ASCP considers the MRR and some aspects of MTM services in the LTC setting to be distinct processes even though they share common goals regarding quality, safety, and cost effectiveness: MTM and MRR are mandated by separate federal regulations. MRR is an ongoing process occurring at least monthly for every resident and is conducted by a consultant pharmacist in the facility; in contrast, MTM explicitly targets selected beneficiaries, may or may not occur routinely, and may or may not be conducted by a pharmacist. MTM has explicit prescription cost control components, per CMS regulation, to help maintain the financial sustainability of the Part D benefit. MTM has a greater focus on risk management of high cost, high risk beneficiaries than does MRR (for non Part A residents). 12

13 In the LTC setting, the MRR is the best mechanism for ensuring that patients receive a thorough review of their medication therapy. It is timely, accurate, comprehensive, and does not take into consideration drug costs when a consultant pharmacist makes medication change recommendations for a patient. A Part D Plan sponsor typically prompts the need for MTM services. Currently there is no standard or description that established criteria for consultant pharmacist delivered MTM services in the LTC setting. This definition is highly variable among providers, Part D Plan sponsors, and other stakeholders in the industry. With no standard in place, MTM may be of limited value to an LTC patient expected to remain in a facility for an indefinite period of time. However MTM services provided separately from and in addition to the MRR can be beneficial for those patients that are high risk and high cost as well as those patients expected to return home or transition to a different care setting. To ensure that the application of MTM services for patients in the LTC setting is equally and effectively applied, ASCP respectfully requests CMS work collaboratively with ASCP to develop and establish standards and criteria for effective application and delivery of MTM services to patients in the LTC setting. The process of creating these standards would include developing an enhanced understanding of the process and patient outcomes related to the MRR and delineating the unique aspects of MRR and MTM. ASCP further requests CMS delay any additional requirement to provide MTM services to patients in LTC in addition to the MRR until such standards can be established and effectively disseminated throughout the LTC industry. Part D Sponsor contractual agreements to provide MTM services to LTC beneficiaries in coordination with MRRs performed by a consultant pharmacist ASCP recommends Medicare Part D plans contract directly with a consultant pharmacist, (for example: the consultant pharmacist contracted by the LTCF) and establish a business relationship for MTM services for the following reasons: Consultant pharmacists have a critical role in achieving positive clinical outcomes because they have access to the complete medical record and are familiar with the residents, staff, and prescribers of a particular facility. The State Operations Manual (SOM) mandates coordination of pharmaceutical services through the consultant pharmacist if and when multiple service providers, such as Prescription Drug Plans (PDPs), are utilized. This mandate illustrates the necessity of the PDP to coordinate any MTM services that are provided to long term care beneficiaries with the facility contracted consultant pharmacist. The consultant pharmacist has expertise in the complexity and frailty of patients residing in long term care facilities and the regulations governing these facilities. 13

14 Contracting with the consultant pharmacist for the provision of MTM services would be the most efficient use of available resources, which limits the investment risk to a Medicare Part D plan sponsor. Consultant pharmacists have proven a return on investment from their clinical services, both financially and clinically. Consultant pharmacists clinical services have decreased overall health care costs and improved outcomes. In consideration of payment for MTM services provided to LTC beneficiaries from Part D sponsors to consultant pharmacists, ASCP believes the following principles should be applied: There must be a mechanism for adequate, market based payment of MTM services in long term care settings. An MTM contract between a Medicare Part D plan and pharmacy, or pharmacist, must define the types of MTM services to be paid for and the billing process and specific codes to be utilized. For example, the definition could expand face toface intervention to include communications with family, a caregiver, or a responsible party for LTC beneficiaries with cognitive impairment. Medicare Part D plans should allow for payment to either individual pharmacies or pharmacists for the provision of MTM services. Use of the consultant pharmacist to evaluate outcomes of previous MTM interventions should be paid for as a separate MTM service. Part D plans should consider using National Provide Identification numbers (NPI) to assist with identifying and creating networks of pharmacists as well as facilitating payment. Currently there are three time based Current Procedural Terminology (CPT) codes approved for the provision of MTM services by pharmacists. These CPT payment codes are for face to face MTM interventions. While a face to face intervention may be applicable for some long term care beneficiaries, it is not applicable to the majority of MTM services provided to this population. In the LTC setting, the logistics for carrying out MTM services may be different in that the MTM occurs at the point of care instead of at the point of sale, as is the case in the ambulatory setting. In the LTC setting, face to face may actually mean face to family, faceto caregiver, face to guardian, or face to prescriber, if a resident is cognitively impaired and unable to directly interact with the MTM service provider. Application of telehealth to delivery of MTM in the LTC setting ASCP would be opposed to the use of a remote MTM process for LTC beneficiaries. Remote programs have limitations for the following reasons: The process is inefficient. The beneficiary and the chart are located in the facility but the physician is not. Physicians often use extenders (such as nurse 14

15 practitioners) in LTC, which means the prescriber most knowledgeable about the beneficiary is not the one receiving the MTM communication from the Medicare Part D plan. Many patients residing in LTC settings have cognitive impairments. These beneficiaries rarely will be able to interact with, or respond to, MTM services. Evaluation of the appropriateness of drug therapy requires knowledge of patient values and priorities, and the goals of drug therapy as outlined in the resident s plan of care. ASCP believes Medicare Part D plans will have more success with coordinating MRRs and MTM programs in LTCFs by establishing business relationships with consultant pharmacists at these facilities for the following reasons: Greater clinical, regulatory and procedural expertise when performing the MTM services or evaluating the Medicare Part D plan s recommendations Access to more comprehensive data through the residents health records located in the facilities Reduced cost of the prescription drug benefit by using an existing resource Demonstrated ability to improve clinical outcomes. 15