I 111th CONGRESS 1st Session H. R. 3108 IN THE HOUSE OF REPRESENTATIVES June 26, 2009 Mr. Ross introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To amend part D of title XVIII of the Social Security Act to promote medication therapy management under the Medicare part D prescription drug program.

1.

Short title

This Act may be cited as the Medication Therapy Management Benefits Act of 2009.

2.

Findings

Congress finds the following: (1)Medications are important to the management of chronic diseases that require long-term or lifelong therapy. Pharmacists are uniquely qualified as medication experts to work with patients to manage their medications and chronic conditions and play a key role in helping patients take their medications as prescribed. (2)Nonadherence with medications is a significant problem. According to a report by the World Health Organization, in developed countries, only 50 percent of patients with chronic diseases adhere to medication therapies. For example, in the United States only 51 percent of patients taking blood pressure medications are adherent; similarly, only 40 to 70 percent of patients taking antidepressant medications adhere to prescribed therapies. (3)Failure to take medications as prescribed costs over $177 billion dollars annually. The problem of nonadherence is particularly important for patients with chronic diseases that require use of medications; poor adherence leads to unnecessary disease progression, reduced functional status, lower quality of life, and premature death. (4)When patients adhere to, or comply with, their medication therapy, it is possible to reduce higher-cost medical attention, such as emergency department visits and catastrophic care, and avoid the preventable human costs that impact patients and those who care for them. (5)Studies have clearly demonstrated that community-based medication therapy management (MTM) services provided by pharmacists improve health care outcomes and reduce spending. For example, the Asheville Project—a diabetes program designed for city employees in Asheville, North Carolina, and delivered by community pharmacists—resulted over a 5-year period in a decrease in total direct medical costs ranging from $1,622 to $3,356 per patient per year, a 50 percent decrease in the use of sick days, and an increase in productivity accounting for an estimated savings of $18,000 annually. Another project involving pharmacist-provided care to patients with high cholesterol increased compliance with medication to 90 percent from a national average of 40 percent. In North Carolina, the ChecKmeds NC program, which offers eligible seniors one-on-one MTM consultations with pharmacists, saved an estimated $10,000,000 in healthcare costs and avoided numerous health problems in the first year of the program for the more than 15,000 seniors receiving MTM. Similar results have been achieved in several other demonstrations using community pharmacists. (6)Therefore, enhancement of the MTM benefit under part D of the Medicare program should be a key component of the national health care reform agenda.

3.

Improvement in part D medication therapy management (MTM) programs

(a)

In general

Section 1860D–4(c)(2) of the Social Security Act (42 U.S.C. 1395w–104(c)(2)) is amended— (1)by redesignating subparagraphs (C) through (E) as subparagraphs (F) through (H), respectively; and (2)by inserting after subparagraph (B) the following new subparagraph: (C)

Required reviews and interventions

Beginning in the first plan year after the date of the enactment of the Medication Therapy Management Benefits Act of 2009, PDP sponsors shall offer medication therapy management services to targeted beneficiaries described in subparagraph (A)(ii) that include, at a minimum, the following to increase adherence to prescription medications: (i)An annual comprehensive medication review furnished person-to-person by a licensed pharmacist. The comprehensive medication review— (I)shall include a review of the individual’s medications, creation of a personal medication record, and a recommended medication action plan in consultation with the individual and the prescriber; and (II)shall include providing the patient with a written or printed summary. (ii)Targeted medication reviews furnished person-to-person by a licensed pharmacist offered no less frequently than once every quarter to assess medication use since the last annual comprehensive medication review, to monitor unresolved issues, to identify problems with new drug therapies or if the individual has experienced a transition in care. (iii)Followup interventions, which may be provided person-to-person or through other interactive means, on a schedule and frequency recommended by the prescriber or a licensed pharmacist. . (b)

Increase availability of MTM services to beneficiaries and increase community pharmacy involvement in provision of MTM services

(1)

Increased beneficiary access to MTM services

Section 1860D–4(c)(2) of such Act (42 U.S.C. 1395w–104(c)(2)), as amended by subsection (a), is further amended— (A)in subparagraph (A)(ii)(I), by inserting before the semicolon at the end the following: or any chronic disease that accounts for high spending in the Medicare program including diabetes, hypertension, heart failure, dyslipidemia, respiratory disease (such as asthma, chronic obstructive pulmonary disease or chronic lung disorders), bone disease-arthritis (such as osteoporosis and osteoarthritis), rheumatoid arthritis, and mental health (such as depression, schizophrenia, or bipolar disorder); (B)by adding at the end of subparagraph (A) the following new clause: (iii)

Identification of individuals who may benefit from medication therapy management

The PDP sponsor shall identify a process subject to the Secretary’s approval that allows pharmacists or other qualified providers to identify enrollees for medication therapy management interventions where such individuals are not described as targeted beneficiaries under clause (ii) or are not otherwise offered services described in paragraph (C). ; and (C)by inserting after subparagraph (C) the following new subparagraph: (D)

Medication reviews for dual eligibles and enrollees in transition of care

Without regard to whether an enrollee is a targeted beneficiary described in subparagraph (A)(ii), the medication therapy management program under this program shall offer— (i)a comprehensive medication review described in subparagraph (C)(i) at the time of initial enrollment under the plan for an enrollee who is a full-benefit dual eligible individual (as defined in section 1935(c)(6)); and (ii)a targeted medication review described in subparagraph (C)(ii) for any enrollee at the time of transition of care (such as being discharged from a hospital or another institutional setting) where new medications have been introduced to the individual’s therapy. . (c)

Community Pharmacy Access

Section 1840D–4(c)(2) of such Act is further amended by inserting after subparagraph (D) the following new subparagraph: (E)

Pharmacy access requirements

A PDP sponsor shall offer any willing pharmacy in its network the ability to provide medication therapy management services to assure that enrollees have the option of obtaining services under the medication therapy management program from community-based retail pharmacies. . (d)

Reimbursement and incentives based on performance

(1)

Appropriate reimbursement for the provision of MTM services

Section 1860D–4(c)(2)(H) of such Act, as redesignated by subsection (a), is amended by striking the first sentence and inserting the following: The PDP sponsor shall reimburse pharmacists and other entities furnishing medication therapy management services under this paragraph based on the resources used and the time required to provide such services.. (2)

Evaluation of performance for payment incentives

Section 1860D–4(c)(2) of such Act (42 U.S.C. 1395w–104(c)(2)) is amended by adding at the end the following new subparagraph: (I)

Evaluation of performance

(i)

Data collection and provider measures

Effective beginning in the first plan year after the date of the enactment of the Medication Therapy Management Benefits Act of 2009, the Secretary shall establish measures and standards for data collection by PDP sponsors to evaluate performance of pharmacies and other entities in furnishing medication therapy management services. Such measures shall be designed to help assess and improve overall quality of care, including a reduction in adverse medication reactions, improvements in adherence and persistence in chronic medication use, and a reduction in drug spending, where appropriate. PDP sponsors shall also compare outcomes based on the type of entity offering such services and shall ensure broader participation of entities that achieve better outcomes with respect to such services. The measures established under this clause shall include measures developed by the Pharmacy Quality Alliance (PQA) in the case of pharmacist providers. (ii)

Continual development and incorporation of medication therapy management measures in broader health care outcomes measures

The Secretary shall support the continual development and refinement of performance measures described in clause (i), including the incorporation of medication use measures as part of broader health care outcomes measures. The Secretary shall work with state Medicaid programs to incorporate similar performance-based measures into State-required Drug Use Review programs under title XIX. (iii)

Incentive payments

Beginning with plan year 2011, pharmacies and other entities that furnish medication therapy management services under this part shall be provided (in a manner specified by the Secretary) with additional incentive payments based on the performance of such pharmacies and entities in meeting the quality measures established under clause (i). Such payments shall be made from the Medicare Prescription Drug Account except that such payments may be made from the Federal Hospital Insurance Trust Fund or the Federal Supplemental Medical Insurance Trust Fund if the Secretary determines, based on data under this part and parts A and B, that such services have resulted in a reduction in expenditures under part A or part B, respectively. .