The pharmaceutical industry has grown increasingly complex over the past few decades as the field works to meet the needs of an aging and ailing U.S. population. Many individuals, especially the elderly, struggle with numerous comorbidities and must manage multiple treatment plans, often without the assistance of their siloed providers.

While the movement toward accountable care aims to break down those siloes, coordinating multiple medication regimens remains a struggle for hundreds of thousands of Americans. Medication Therapy Management (MTM) aims to address that need.

We spoke with Mr. Paul DeMuro of Broad and Cassel and Dr. Stephanie Gernant of Nova Southeastern University to discuss the challenges facing MTM in addition to the role it can play in improving health care.

Question: Medical errors are a leading cause of death in the United States. What are health plans doing to reduce this?

Answer: Medical errors not only damage human life but are a drain on the economy as the 1.5 million medication adverse events occurring in the US every year come at a $177 billion expense. To reduce these errors, health plans have begun to utilize Medication Therapy Management (MTM): a group of services that pharmacists provide, including medication reconciliation, patient education, disease state management, and medication safety surveillance. During MTM, patients' individual therapies, comorbidities, and goals of therapy are evaluated for optimization.
MTM programs began in 2003 with the passage of the Medicare Modernization Act and the development of Medicare Part D plans for prescription drug coverage. However, MTM programs have had mixed results, most likely because Americans are taking and spending more on medications than ever before and the programs vary widely in scope of service. To optimize MTM, the Centers for Medicare & Medicaid Services (CMS) has introduced Enhanced MTM Models; these models will test incentive payments' and regulatory flexibilities' effect on MTM outcomes. Those working in a health care setting should expect to see an increase in MTM programs, especially over the next one to three years.

Q: What are some of the most pressing legal issues with regards to a Medication Therapy Management Program?

A: First and foremost is data sharing from EHRs. Some Part D plans complete their own MTM “in house,” meaning they hire their own pharmacist employees to deliver the service (most often telephonically). Others contract with community pharmacists/pharmacies, while other health plans contract with independent, private, or university-run MTM programs. Some Part D plans seem to believe that these pharmacists, pharmacies, or other MTM providers are not covered entities and thus are ineligible to receive patient medical records under HIPAA regulations. Not only are pharmacist MTM providers covered entities when they provide a health service to the patient, but they necessarily need access to patient medical records to complete an optimized MTM.

Secondly, those working with legal departments of health care systems will encounter MTM contracts; these contracts will cover payments, performance reporting, quality assurance, data sharing, and deliverables. While the American Pharmacist Association publishes billing guidelines for MTM, no standard, universal contracts exist. Similarly, MTM programs may choose to credential pharmacists to determine if they meet certain standards. Those working for health plans or health systems may want to assure similar standards are outlined in their contracts. In addition, some clinically integrated networks and health care systems may face certain challenges in developing contracts that compensate pharmacists delivering services in the MTM program. In some cases, for large networks, payment may go to a parent company. Other health systems and plans may be more interested in contracting with independent contractors such as board certified pharmacist-clinicians and licensed consultant pharmacists. Similarly, unless the pharmacists are all employees of one legal entity, it is important to execute contracts with them individually so that they become part of the MTM network. In addition, any other providers and/or entities who might be part of the network should be contractually obligated to the network. The network also will want to have contracts with any entities for which it will be providing MTM services.

Furthermore, those working with health agencies should be aware of regulatory approvals. As noted above, the program may be part of CMS Part D Enhanced MTM model or the traditional Part D MTM program and thus will have to qualify under those programs. MTM is an important component of the delivery of quality care in a cost-effective manner, and some MTM programs are outside of Part D. Pharmacists are licensed by the state in which they practice, so while their participation in an MTM program may not trigger any other state law considerations, it is important to carefully analyze whether there might be any state and federal law considerations.

Finally, if the MTM provider(s) is involved in research, it may need approval from an Institutional Review Board, as MTM research often falls under human subjects research. Protocols, credentials, and support letters will be required from all participating entities.

Q: I thought pharmacists just counted pills. Are these the same people who will deliver MTM services?

A: That is a common misconception. Previously, to become a licensed pharmacist, one attended school for 4 years. Over the last few decades, as reliance on medications has increased and focus on quality of care has shifted, pharmaceutical education has shifted. Thousands of New Drug Applications have been approved by the FDA over the last 50 years, resulting in health systems needing experts who know how to utilize, manage, and optimize these medications in patients with hundreds of comorbidities. Today, all pharmacists complete a doctoral program that includes up to eight years of education and training. After receiving their Doctorates in Pharmacy, these PharmDs often complete another one to three years of post-graduate training in the form of residencies and/or fellowships and obtain board certification.

Q: Are there professional liability considerations to be aware of?

A: It is important to know that not all patients are selected by health plans to receive MTM. On the contrary, CMS allows Part D plans to create their own MTM inclusion criteria within certain parameters of patients' number of medications, conditions, and overall drug expenditure. Similarly, non-part D payers can chose whatever criteria they want. A patient who was ineligible for MTM services and experienced an adverse event may claim that if he or she had received MTM services, the event would have been prevented. Conversely, if a patient was selected to receive MTM and experienced an adverse event, he or she may claim that the MTM service was part of the cause.

Q: How do MTM programs interface with other existing health systems?

A: MTM programs may contract with health care systems, clinically integrated networks, and Accountable Care Organizations (ACOs). Such ACOs must permit patients to visit any provider of his or her choosing; if a patient does not regularly frequent the community pharmacies that provide MTM, managing the patient's care may be more difficult.

Q: Will these programs create a nightmare for compliance staff?

A: No. Compliance professionals are adroit at addressing changes in the dynamic health care marketplace, and the expansion of MTM programs is one such change. Compliance staff should treat MTM programs as any other health service and should educate their constituents and develop programs to monitor and audit compliance.

Q: What are the technological implications of MTM programs?

A: Unfortunately, as in many realms outside of health care, laws have not kept pace with technology. MTM programs can and do employ mHealth, social media, telemedicine, and other communication technologies. Applicable federal and state law may or may not provide for payment for some of these technologies in certain forms. Readers should make their health systems aware, as provision of such services is regulated. In addition, the various laws and regulations may not be consistent among states.

Q: What should I do now?

A: Managing medications cannot be an afterthought for health systems. MTM is part of precision/personalized medicine, but it is an integral part of patient care management. As the Affordable Care Act focuses on preventative care and chronic condition management, it is likely that more pharmacists will deliver MTM and other services as part of care management teams, especially in an accountable care setting. As the price of pharmaceuticals rises and more people take more and more drugs, MTM will move closer to center stage. Systems that recognize it and embrace it earlier should experience better outcomes and higher cost savings. As such, attorneys need to be facile in these concepts to assist their clients in the design, implementation and operation of such programs.