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October Legislative Update

Medication Therapy Management

Kelly Vyzral, Director of Government Affairs

Medication Therapy Management
Pursuant to passage of the Medicare Prescription Drug, Improvement and Modernization Act (MMA) of 2003, the Centers for Medicare & Medicaid Services (CMS) recently issued rules that have the potential to greatly affect the pharmacy profession. These regulations will provide direction to sponsors of prescription drug plans on how to provide their chronically ill beneficiaries medication therapy management services. These regulations would allow pharmacists to provide these services and be reimbursed.

CMS has requested assistance in drafting the final regulations for the section on Medication Therapy Management Services (MTMS). OPA would also be interested in hearing your thoughts on the proposed rules as well.

Below is a summary of the draft rules regarding the Medication Therapy Management Program (MTMP). If you would like to read the rules in full, please go to: http://www.cms.hhs.gov/medicarereform/default.asp. />
Please consider making comments. Your views are important on a state as well as a federal level, and we will be looking at them very closely as we in decide how to go forward with ideas like this on a state level in the future.

Please forward any comments or questions to Kelly Vyzral, Director of Government Affairs at 614.798.0037, or
kvyzral@ohiopharmacists.org.

Medication Therapy Management Program
Prescription Drug Plans (PDPs) and Medicare Advantage offering Prescription Drug Coverage (MA-PDs) must establish a medication therapy management program (MTMP). The purpose of the MTMP is to provide services that will optimize therapeutic outcomes for targeted beneficiaries. Specific services to be provided under a MTMP would be distinct from those required for dispensing medication. MTM services (MTMS) would be reimbursable when adopted by a plan and only when provided to targeted beneficiaries.

Targeted Beneficiaries
Targeted beneficiaries include individuals with multiple chronic diseases, who are taking multiple Part D covered drugs, and are likely to incur annual costs that exceed a certain level. CMS has the authority to set the level of annual costs that must be incurred by a beneficiary to qualify for MTMS; however, CMS prefers to delegate the determination of “high annual costs” to the drug plan sponsor.

MTMP Services
MTMPs may include elements designed to promote:
  • Enhanced enrollee understanding – through beneficiary education counseling, and other means – that promotes the appropriate use of medications and reduces the risk of potentially adverse events associated with medications;
  • Increased enrollee adherence to prescription medication regimens (e.g., through refill reminders, special packaging, and other compliance programs and other appropriate means);
  • Detection of adverse events and patterns of overuse and underuse of prescription drugs.

    In addition to those services mentioned in the MMA, services could include, but not be limited to:
  • Performing patient health status assessments
  • Formulating prescription drug treatment plans
  • Managing high cost “specialty” medications
  • Evaluating and monitoring patient response to drug therapy
  • Providing education and training
  • Coordinating medication therapy with other care management services
  • Participating in State-approved collaborative drug therapy management

    CMS does not expect provision of these services to be limited to such programs.

    CMS envisions MTMPs potentially spanning a range of services, from simple to complex. In addition to MTMPs providing for different types of services, CMS also anticipates the need for different levels of service based on the individual requirements of the targeted beneficiaries. The level of service should be determined by time and resources required to accommodate the specific needs of the individual beneficiary. MTMPs would include policies and procedures for ensuring targeted beneficiary access to the appropriate types and levels of service offered by the particular PDP or MA-PD plan.

    CMS may require plans to demonstrate the types of services, levels of service, and quality outcomes associated with their MTMPs to further aid beneficiaries with choosing the plan that will best meet their needs.

    A MTMP, as adopted by a plan, would have to be developed in cooperation with patients, and licensed practicing pharmacists and physicians.

    CMS considers MTMPs to be administrative activities similar to Quality Assurance (QA), Drug Utilization Review (DUR), or fraud, abuse and waste control measures. Therefore, MTMP services would not involve direct beneficiary cost-sharing and Part D enrollees would not be required to pay separate fees for these services, although the cost could be reflected in the premium rate. The cost of a MTMP is considered an administrative cost incident to appropriate drug therapy and, therefore, not an additional benefit.

    MTMS Providers
    CMS believes that pharmacists will be the primary providers of MTMS; however, MTMPs could also include other qualified health care professionals as providers of services. The individual needs of the targeted beneficiary should determine the appropriate provider and setting for MTMP services. For example, consultant pharmacists will likely provide services to beneficiaries in long-term care facilities; retail pharmacists could provide those same services to ambulatory beneficiaries.

    CMS believes that “beneficiary choice and on-going beneficiary-provider relationships should play a role in determining the best provider for MTMP services… While population-based QA and cost control measures might adequately be served by impersonal telephone services, CMS believes that telephone services are only one mode of providing MTMS. Active beneficiary participation and consistent delivery of quality MTMP services will require developing and maintaining on-going beneficiary-provider relationships.”

    MTMS Fees
    In establishing fees for pharmacists and others providing MTMP services, the plan must take into account the resources and time associated with implementing the MTMP. Plans must describe, as part of their application, their mechanism to consider the resources used and the time required to implement MTMP in establishing fees. Plans must, upon request, disclose to CMS the management and dispensing fees and the portion paid for MTMS services to pharmacists and other providers. If CMS receives complaints that a plan is not paying pharmacists or others in accordance with the fees discussed in the application, CMS will investigate.

    CMS does not set a certain amount plans must pay pharmacists or other providers to provide MTMP services. CMS does not believe it has the authority to do so. CMS does state that it believes that MTMS’ fees are separate and distinct from dispensing fees.

    While the MMA states that PDP sponsors must disclose to the Secretary the amount of “any such management or dispensing fees,” it merely governs disclosure and does not require that MTMP be included in the dispensing fee (and the MMA distinguishes management fees from dispensing fees that are part of individual prescriptions.)

    Therefore, CMS includes the costs associated with MTMPs, including these management fees, as part of the general administrative overhead costs in the plan bid. For purposes of evaluating the administrative component of a PPD’s bid, CMS will ask a plan sponsor to disclose the fees it pays to pharmacists or others, including an explanation of those fees attributable to MTMP services. CMS would be prohibited from disclosing the specific fees in a manner that links the fees to the particular pharmacy or other provider, except in certain cases.

    Fraud, Abuse, and Waste
    Plans must provide a program to control fraud, abuse, and waste. Fraud, abuse, and waste control efforts should apply not only to the plans, but also to the PBMs, pharmacies, physicians, and others the plan deals with. Plans can develop and utilize methods such as data analysis; record audit of PBMs, pharmacies, physicians, and other providers; DUR; and methods to consider and resolve disputes related to pharmacies’, physicians’, and other providers’ dissatisfaction to ensure the integrity of all entities.

    CMS is concerned with the inappropriate switching of prescriptions by a plan without consulting a prescribing physician. While switching from brand to generic may be appropriate, switching from one brand to another brand may not be without consultation.

    Quality Improvement Organization Activities
    Under the MMA, Quality Improvement Organizations (QIO) are required to offer providers, practitioners, Medical Advantage (MA) organizations, and PDP sponsors quality improvement assistance pertaining to health care services, including those related to prescription drug therapy. CMS will issue guidance on how QIOs can provide this assistance and will coordinate the activities of the QIOs with the quality related activities of other parties.

    To fulfill this responsibility, QIOs will need access to data from the transactions between pharmacies and PDP and MA-PD plans. The data would be extracted from the claims data submitted to CMS. CMS anticipates aggregating the data and then distributing it to QIOs to fulfill their requirements for quality improvement as specified in their contracts and in response to requests. Any information collected by QIOs would fall under confidentiality provisions.

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