Pharmacy Law CE Column

By Laura Carpenter, RPh, JD, attorney and pharmacist, founder Carpenter Law Firm PC and Zachary Edgar, candidate for JD, 2012, University of Arizona

Healthcare reform: Medication therapy management

Medication therapy management, also referred to as MTM, is a term that describes a broad range of healthcare services provided by pharmacists. In short, MTM is a service or group of services that optimizes therapeutic outcomes for individual patients and includes medication therapy reviews, pharmacotherapy consults, anticoagulation management, immunizations, health-and-wellness programs and many other clinical services. Pharmacists provide medication therapy management to help patients benefit the most from their medications by actively managing drug therapy and by identifying, preventing and resolving medication-related problems.¹

MTM services were developed in the 1990s to assist patients and physicians in better management of therapeutic and cost outcomes of drug therapy. Generally, these services were provided without reimbursement to the pharmacist. It was not until 2003, when the Medicare Modernization Act was enacted, that MTM services became more widely recognized and reimbursed when the government required Part D sponsors to design and implement MTM programs for certain beneficiaries.²

These Part D MTM programs showed significant cost containment and improved patient health outcomes, leading Congress to expand MTM programs through grants for providers to design and implement MTM programs in the Patient Protection and Affordable Care Act, also known as PPACA or Healthcare Reform.3 In addition, PPACA codified some of the regulatory changes made by the Centers for Medicare and Medicaid Services in 2010.

MTM and Medicare

Medicare Part D defines MTM as "a program of drug therapy management that may be furnished by a pharmacist and that is designed to assure, with respect to targeted beneficiaries, that covered Part D drugs under the prescription drug plan are appropriately used to optimize therapeutic outcomes through improved medication use, and to reduce the risk of adverse events."4 MTM programs must include the following for each targeted beneficiary:

(1) Interventions for both beneficiaries and prescribers
(2) Annual comprehensive medication reviews with written summaries
(3) Quarterly targeted medication reviews with follow-up interventions if necessary⁵

In addition, Medicare recommends that pharmacists engaged in MTM counsel beneficiaries so that they can better understand their medications, use them appropriately and reduce the risk of adverse events. Further, Medicare recommends that MTM programs should include methods to increase medication adherence, such as medication refill reminders, special packaging and other compliance programs. Finally, it is suggested that MTM programs involve processes to detect adverse drug events and patterns of overuse and underuse.⁶ MTM programs must be developed in cooperation with licensed pharmacists and physicians, and they also must allow beneficiaries to opt-out of the MTM program.⁷

This year, CMS revised its MTM regulations in order to increase consistency among MTM programs in determining which beneficiaries should be targeted to participate in MTM: Part D enrollees that have multiple chronic diseases, are taking multiple Part D drugs and are likely to incur annual costs that exceed a predetermined level.⁸ PPACA also revised the requirements for Part D plans providing MTM programs under grants or contracts with CMS.

A beneficiary must have at least two chronic diseases to qualify. However, a plan cannot require a beneficiary to have more than three chronic diseases in order to qualify.⁹ According to the new MTM grant program in PPACA, beneficiaries must be targeted if they have two chronic diseases.¹⁰ Sponsors must target at least four of the following chronic diseases: hypertension, heart failure, diabetes, dyslipidemia, respiratory disease, bone disease-arthritis and mental health diseases.¹¹

Target beneficiaries also must be taking multiple drugs that are covered by Part D in order to qualify.¹² Before 2010, the thresholds specified by sponsors were between two and 15 different drugs, meaning that if a person had two different drugs they could qualify, and if they were taking fifteen drugs they had to qualify.¹³ As of 2010, the minimum required for eligibility is between two and eight drugs.¹⁴ PPACA will amend the law so that if the patient takes four or more medications, including over-the-counter medications and dietary supplements, then they will qualify to be a targeted beneficiary.¹⁵

The final requirement is that the beneficiary will likely incur an annual cost of at least $3,000 for all Part D drugs.¹⁶ In 2012 and the following years, the amount will be $3,000 plus the annual percentage increase in average per capita aggregate expenditures for Part D drugs for eligible individuals. This figure will be based on data for the 12-month period ending in July of the previous year.¹⁷ In addition, PPACA has added two more options that can be used to determine whether a patient should be enrolled in an MTM program: if they take any high-risk medications or if they have undergone a transition of care (hospital discharge or switching prescribers).¹⁸

On March 23, 2012, the Plan D sponsors will be required to do the following: (1) an annual comprehensive medication review furnished person-to-person or using telehealth technologies by a pharmacist or other qualified provider. Tshis will include a review of the individuals medications and may result in the creation of a recommended medication action plan or other actions in consultation with the individual and input from the prescriber, and a written summary of the results of the review; (2) follow-up interventions as warranted; (3) the plan sponsor shall assess, at least on a quarterly basis, the medication use of individuals who are at risk but not enrolled in the MTM program; and (4) the plan sponsor shall have in place a process to automatically enroll targeted beneficiaries and also permit beneficiaries to opt-out of enrollment in the program.¹⁹

The changes in PPACA were made in order to try to incorporate more Medicare beneficiaries into MTM programs. In addition, changes made in 2010 by CMS and the subsequent changes made in PPACA are intended to make MTM programs more consistent for beneficiaries so that health outcomes and cost containment also will be more uniform.

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1. American Pharmacists Association. Medication Therapy Management MTM Central. Available at: www.pharmacist.com/AM/Template.cfm?section=MTM#nogo Accessed July 1, 2010.

2. Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Pub. L. No. 108-173.

3. HR 3590 (2010).

4. 42 U.S.C. § 1395w-104(c)(2)(A)(i).

5. 42 C.F.R. § 423.153(d)(1)(vii).

6. 42 U.S.C. § 1395w-104(c)(2)(B).

7. 42 C.F.R. § 423.153(d)(3).

8. Centers for Medicare and Medicaid Services. Medicare Part D Medication Therapy Management Programs  2010 Fact Sheet 1. Available at: www.cms.hhs.gov/PrescriptionDrugCovContra/Downloads/MTMFactSheet.pdf Accessed June 23, 2010.

9. 42 C.F.R. § 423.153(d)(2)(i).

10. HR 3590 § 3503(d)(3).

11. Centers for Medicare and Medicaid Services. Medicare Part D Medication Therapy Management Programs  2010 Fact Sheet 2. Available at: www.cms.hhs.gov/PrescriptionDrugCovContra/Downloads/MTMFactSheet.pdf Accessed June 23, 2010.

12. 42 U.S.C. § 1395w-104(c)(2)(A)(ii)(II).

13. Centers for Medicare and Medicaid Services. Medicare Part D Medication Therapy Management Programs  2010 Fact Sheet 4. Available at: www.cms.hhs.gov/PrescriptionDrugCovContra/Downloads/MTMFactSheet.pdf Accessed June 23, 2010.

14. 42 C.F.R. § 423.153(d)(2)(ii).

15. HR 3590 § 3503(d)(1).

16. 42 C.F.R. § 423.153(d)(2)(iii).

17. Id.; 42 C.F.R. § 423.104(d)(3)(iv).

18. HR 3590 § 3503(d)(2)-(4).

19. HR 3590 § 10328(a)(2)(C)-(E).