II 112th CONGRESS 1st Session S. 274 IN THE SENATE OF THE UNITED STATES February 3, 2011 Mrs. Hagan (for herself, Mr. Franken, Mr. Brown of Ohio, and Mr. Johnson of South Dakota) introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To amend title XVIII of the Social Security Act to expand access to medication therapy management services under the Medicare prescription drug program.

1.

Short title

This Act may be cited as the Medication Therapy Management Empowerment Act of 2011.

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 and only 40 to 70 percent of patients taking antidepressant medications adhere to prescribed therapies. (3)Failure to take medications as prescribed costs over $290,000,000,000 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 prescribed 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 the individuals who care for them. (5)Studies have clearly demonstrated that community-based medication therapy management services provided by pharmacists improve health care outcomes and reduce spending. (6)The Asheville Project, a diabetes program designed for city employees in Asheville, North Carolina, that is 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. (7)Another project involving care provided by pharmacists to patients with high cholesterol increased compliance with medication to 90 percent from a national average of 40 percent. (8)In North Carolina, the ChecKmeds NC program, which offers eligible seniors one-on-one medication therapy management consultations with pharmacists, has saved an estimated $34,000,000 in healthcare costs and avoided numerous health problems since implementation in 2007 for the more than 31,000 seniors receiving such consultations. (9)Results similar to those found under such projects and programs have been achieved in several other demonstrations using community pharmacists.

3.

Improvement in part d medication therapy management programs

(a)

Increased availability and community pharmacy involvement in the provision of medication therapy management services

(1)

Increased beneficiary access to medication therapy management services

Section 1860D–4(c)(2) of the Social Security Act (42 U.S.C. 1395w–104(c)(2)), as amended by section 10328 of the Patient Protection and Affordable Care Act (Public Law 111–148), is amended— (A)in subparagraph (A)— (i)in clause (ii)(I), by inserting or any chronic disease that accounts for high spending in the program under this title, 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) before the semicolon at the end; and (ii)by adding at the end the following new clause: (iii)

Identification of individuals who may benefit from medication therapy management

The PDP sponsor shall, subject to the approval of the Secretary, establish a process for identifying individuals who— (I)are not targeted beneficiaries described in clause (ii); (II)are not otherwise offered medication therapy management services; and (III)a pharmacist or other qualified provider determines may benefit from medication therapy management services. For purposes of this paragraph, any individual identified under this clause shall be treated as a targeted beneficiary described in clause (ii).; (B)by redesignating— (i)subparagraphs (E), (F), and (G), as redesignated by paragraph (1) of such section 10328, as subparagraphs (G), (H), and (I), respectively; and (ii)subparagraph (E), as added by paragraph (2) of such section 10328, as subparagraph (F); and (C)by inserting after subparagraph (D) the following new subparagraph: (E)

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 paragraph shall offer the following: (i)In the case of an enrollee who is a full-benefit dual eligible individual (as defined in section 1935(c)(6)), a comprehensive medication review described in subparagraph (C)(i). The review under the preceding sentence shall be offered at the time of the initial enrollment of such individual in the prescription drug plan. (ii)In the case of any enrollee who is experiencing a transition in care (such as being discharged from a hospital or other institutional setting), a targeted medication review described in subparagraph (C)(ii) of any new medications that have been introduced to the enrollee's therapy. The review under the preceding sentence shall be offered at the time of such transition. . (2)

Access to medication management therapy

Section 1840D–4(c)(2) of such Act (42 U.S.C. 1395w–104(c)(2)) is further amended— (A)by redesignating— (i)subparagraphs (G), (H), and (I), as redesignated by paragraph (1)(B)(i), as subparagraphs (H), (I), and (J), respectively; and (ii)subparagraph (F), as redesignated by paragraph (1)(B)(ii), as subparagraph (G); and (B)by inserting after subparagraph (E), as inserted by paragraph (1)(C), the following new subparagraph: (F)

Access requirements

In order to assure that enrollees have the option of obtaining medication therapy management services under this paragraph, a PDP sponsor shall offer any willing pharmacy in its network and any other qualified health care provider the opportunity to provide such services. . (3)

Appropriate reimbursement for the provision of medication therapy management services

Section 1860D–4(c)(2)(J) of such Act (42 U.S.C. 1395w–104(c)(2)(I)), as redesignated by paragraph (2), is amended— (A)in the heading, by striking Considerations in pharmacy fees and inserting Reimbursement; (B)by striking the first sentence and inserting the following: The PDP sponsor shall reimburse any willing pharmacy in its network and other qualified health care provider furnishing medication therapy management services under this paragraph based on the resources used and the time required to provide such services.; and (C)in the second sentence, by striking any such management or dispensing fees and inserting any such reimbursement. (4)

Effective date

The amendments made by this subsection shall apply to plan years beginning after the date of enactment of this Act. (b)

Incentives based on performance

(1)

Evaluation of performance for payment incentives

Section 1860D–4(c)(2) of the Social Security Act (42 U.S.C. 1395w–104(c)(2)), as amended by subsection (a), is further amended by adding at the end the following new subparagraph: (K)

Evaluation of performance

(i)

Data collection and performance measures

(I)

In general

For plan years beginning after the date of enactment of the Medication Therapy Management Empowerment Act of 2011, the Secretary shall establish measures and standards for data collection by PDP sponsors to evaluate the performance of pharmacies and other entities in furnishing medication therapy management services under this paragraph. (II)

Measures

Measures established under subclause (I) shall be designed to help assess and improve the 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. (III)

Inclusion of certain measures with respect to pharmacist

In the case of pharmacists who furnish medication therapy management services, the measures established under subclause (I) shall include measures developed by the Pharmacy Quality Alliance. (IV)

Encouraging participation of entities that achieve better outcomes

The Secretary shall compare the outcomes of medication therapy management services based on the type of entity offering such services and shall develop appropriate incentives to ensure broader participation in the program offered by the plan sponsor under this paragraph of entities that achieve better outcomes (as defined by the Secretary) with respect to such services. (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 established under clause (i)(I), including the incorporation of medication use measures as part of broader health care outcomes measures. The Secretary shall work with State plans under title XIX to incorporate similar performance-based measures into drug use review programs under section 1927(g). (iii)

Incentive payments

For plan years beginning on or after January 1, 2012, pharmacies and other entities that furnish medication therapy management services under this paragraph shall be provided (in a form and manner specified by the Secretary) additional incentive payments based on the performance of such pharmacies and entities in meeting the performance measures established under clause (i). Such payments shall be made from the Medicare Prescription Drug Account under section 1860D–16, except that such payments may be made from the Federal Hospital Insurance Trust Fund under section 1817 or the Federal Supplementary Medical Insurance Trust Fund under section 1841 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. .