II 114th CONGRESS 2d Session S. 3454 IN THE SENATE OF THE UNITED STATES September 28, 2016 Mr. Carper (for himself and Mr. Roberts ) introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To improve medication adherence.

1. Findings Congress makes the following findings: (1) Eighty to ninety percent of the means by which we prevent and control chronic disease is with medications. Assuring the most appropriate and effective medications are used to optimize patient outcomes is a national priority. The ability of patients to then adhere to the medication regimen becomes vital. (2) Between 1/2 and 2/3 of individuals with chronic diseases in the United States do not take medications as prescribed. (3) Suboptimal medication use, including untreated indications (such as failure to immunize), over or under dosing of medications, safety issues, and low rates of medication adherence result in higher health care costs, reduced effectiveness of health care treatments and regimes, negative health effects for patients, and tens of thousands of deaths on an annual basis. (4) Appropriate medication use and adherence may be lowest among individuals with chronic diseases. (5) Improving medication adherence would reduce unnecessary hospital admissions and emergency room visits. (6) Drug therapy problems including underuse and nonadherence is estimated to cost the healthcare system in the United States over $290,000,000,000 each year. (7) Improving appropriate medication adherence could improve patient health outcomes, reduce health care costs, and lead to productivity gains. 2. National research and reporting strategy for improved medication adherence Part A of title III of the Public Health Service Act ( 42 U.S.C. 341 et seq. ) is amended by adding at the end the following: 310B. National research and reporting strategy for improved medication adherence (a) In general The Secretary, in coordination with the Administrator of the Agency for Healthcare Research and Quality, the Administrator of the Centers for Medicare & Medicaid Services, and the Director of the Centers for Disease Control and Prevention, shall report annual statistics on medication adherence, particularly with respect to individuals with chronic diseases such as cardiovascular disease, hypertension, diabetes, autoimmune diseases, chronic obstructive pulmonary disease, and mental health conditions, to better inform decisionmakers regarding— (1) primary nonadherence, including among patients newly prescribed one or more medications at the time of discharge from an acute care setting; (2) medication persistence; (3) related quality measures with respect to medication and methods to improve medication adherence and medication persistence; and (4) the strategies used by private stakeholders to improve medication adherence among individuals with one or more chronic illnesses. (b) Federal health care programs The research conducted, and information and statistics developed, under subsection (a) (other than paragraph (6) of such subsection) shall be with respect to individuals treated under the following health care programs: (1) The Medicare program under title XVIII of the Social Security Act. (2) The Medicaid program under title XIX of the Social Security Act. (3) The Federal Employees Health Benefits Plan under chapter 89 of title 5, United States Code. (4) The TRICARE program under chapter 55 of title 10, United States Code. (5) Hospital care and medical services furnished by the Department of Veterans Affairs under chapters 17 and 18 of title 38, United States Code. (c) Definitions In this section: (1) The term medication adherence means a patient taking medications as prescribed by their health care provider, which may include the prescribed dosage, time, frequency, and direction. (2) The term medication persistence means the act of continuing treatment with a medication for the prescribed duration. (3) The term primary nonadherence means the failure to fill a newly prescribed medication. (4) The term medication management means medical care provided by a health care professional to optimize drug therapy and improve therapeutic outcomes for patients, including medication therapy management. (d) Reports to Congress The Secretary shall submit to Congress an initial report on the research conducted under this section not later than 1 year after the date of enactment of this section, and an updated report not later than 5 years after submission of such initial report. . 3. Linking Medicare prescription drug and parts A and B claims data Section 1860D–4(c) of the Social Security Act ( 42 U.S.C. 1395w–104(c) ) is amended by adding at the end the following new paragraph: (5) Linking prescription drug and parts A and B claims data (A) In general Notwithstanding any other provision of law, subject to subparagraph (B), effective for plan year 2018 and each subsequent plan year, the Secretary shall, upon request by the PDP sponsor of a prescription drug plan, provide the plan with enrollee claims data under parts A and B, in order to enable the plan to see the items and services furnished to an enrollee under such parts and to provide greater context for the medication regimen of the enrollee. (B) Requirements The data described in subparagraph (A) shall, as determined by the Secretary, be provided to a prescription drug plan on a regular basis and in a format that is computable and accessible to assist plan efforts in identifying and supporting at-risk enrollees. . 4. Recognizing medication management improves quality under Medicare Advantage and Prescription Drug Plans Section 1857(e) of the Social Security Act is amended— (1) in paragraph (4), by striking If the Secretary and inserting Subject to paragraph (5), if the Secretary ; and (2) by adding at the end the following new paragraph: (5) Recognizing medication management improves quality For purposes of calculating the minimum medical loss ratio under paragraph (4) for a contract year (beginning with 2018), the Secretary shall include medication management (as defined in section 310B(c) of the Public Health Service Act) as part of activities that improve health care quality (as described with respect to Medicare Advantage plans and prescription drug plans in sections 422.2430 and 423.2430, respectively, of title 42, Code of Federal Regulations (or in any successor regulation)). . 5. Enhanced medication therapy management model for MA–PD plans Section 1115A(b)(2) of the Social Security Act ( 42 U.S.C. 1315a(b)(2) ) is amended— (1) in subparagraph (A), by adding at the end the following new sentence: The models selected under this subparagraph shall include the model described in subparagraph (D), which shall be implemented by not later than the date that is 1 year after the implementation of the Part D Enhanced Medication Therapy Management Model, as conducted by the Centers for Medicare & Medicaid Services with respect to stand-alone basic prescription drug plans. ; and (2) by adding at the end the following new subparagraph: (D) Enhanced medication therapy management for MA–PD plans (i) In general Subject to clause (ii), the model described in this subparagraph is a model to test, with respect to MA–PD plans (as defined in section 1860D–1(a)(3)(C)), a model for enhanced medication therapy management that is similar to the Part D Enhanced Medication Therapy Management Model, as conducted by the Centers for Medicare & Medicaid Services with respect to stand-alone basic prescription drug plans. (ii) No additional performance payment Under the model described in this subparagraph, an MA–PD plan (as so defined) shall not receive any additional performance payment (other than any applicable percentage quality increase otherwise applicable for the plan under section 1853(o)). .