[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4292 Introduced in House (IH)]

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114th CONGRESS
  1st Session
                                H. R. 4292

   To provide for research and the testing of innovative health care 
    delivery models to improve medication adherence, and for other 
                               purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           December 18, 2015

Mrs. Noem (for herself and Mr. Pascrell) 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 provide for research and the testing of innovative health care 
    delivery models to improve medication adherence, and for other 
                               purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Synchronization & Nonadherence 
Correction (SYNC) Act of 2015''.

SEC. 2. FINDINGS.

    Congress makes the following findings:
            (1) Between one-half and two-thirds of patients with 
        chronic diseases in the United States do not take medications 
        as prescribed.
            (2) Low rates of medication adherence result in higher 
        health care costs, reduced effectiveness of health care 
        treatments and regimens, negative health effects for patients, 
        and tens of thousands of deaths on an annual basis.
            (3) Medication adherence may be lowest among patients with 
        chronic diseases.
            (4) Improving medication adherence would reduce unnecessary 
        hospital admissions and emergency room visits.
            (5) Nonadherence is estimated to cost the United States 
        health care system over $100,000,000,000 each year.
            (6) Improving medication adherence could improve patient 
        health outcomes, reduce health care costs, and lead to 
        productivity gains.

SEC. 3. DEFINITIONS.

    In this Act:
            (1) The term ``applicable individual'' means an applicable 
        individual (as defined in section 1115A(a)(4)(A) of the Social 
        Security Act, 42 U.S.C. 1315(a)(4)(A)) who has been prescribed 
        2 or more chronic care medications.
            (2) The term ``medication adherence'' means a patient 
        taking medications according to the prescribed dosage, time, 
        frequency, and direction.
            (3) The term ``medication wastage'' means, with respect to 
        a medication, a switch of the medication or strength of the 
        medication within the same therapeutic class that occurs before 
        the expected refill date.
            (4) The term ``persistence'' means the act of continuing 
        treatment with a medication for the prescribed duration.
            (5) The term ``primary nonadherence'' means the failure to 
        pickup a newly prescribed medication from a pharmacy.
            (6) The term ``Secretary'' means the Secretary of Health 
        and Human Services.
            (7) The term ``synchronization'' means the coordination of 
        medication refills for a patient taking two or more chronic 
        medications such that the patient's medications are refilled on 
        the same schedule for a given time period.

SEC. 4. NATIONAL RESEARCH AND REPORTING STRATEGY FOR IMPROVED 
              MEDICATION ADHERENCE.

    (a) In General.--The Secretary of Health and Human Services, acting 
through the Agency for Healthcare Research and Quality, the Centers for 
Medicare & Medicaid Services, the Health Resources and Services 
Administration, the Director of the National Institutes of Health, and 
the Director of the Centers for Disease Control and Prevention, and in 
coordination with the Patient-Centered Outcomes Research Institute, 
shall conduct research and develop information to better inform 
decisionmakers regarding medication adherence and medication 
persistence, and methods to improve medication adherence and 
persistence in Federal health programs.
    (b) Activities Included.--The activities described in subsection 
(a) shall include development of annual statistics on recommended 
medications, the rate of medication adherence, the rate of primary 
nonadherence, and the rate of medication persistence for patients with 
chronic diseases such as cardiovascular disease, hypertension, 
diabetes, autoimmune diseases, chronic obstructive pulmonary disease 
(COPD), and mental health conditions treated under the following health 
care programs:
            (1) Medicare.--The Medicare program under title XVIII of 
        the Social Security Act.
            (2) Medicaid.--The Medicaid program under title XIX of such 
        Act.
            (3) FEHBP.--The Federal Employees Health Benefit Program 
        under chapter 89 of title 5, United States Code.
    (c) Biennial Report on Medication Adherence and Medication 
Persistence.--Not later than 2 years after the date of enactment of 
this Act (and annually thereafter), the Secretary shall submit to 
Congress a report on the statistics collected under subsection (a), 
together with recommendations for such legislation and administrative 
action to address problems and improve medication adherence and 
medication persistence as the Secretary determines appropriate.

SEC. 5. TESTING MODELS FOR IMPROVING MEDICATION ADHERENCE.

    (a) In General.--The Secretary shall test innovative health care 
delivery models, as described in subsections (b) and (c), to improve 
medication adherence and medication persistence, with the goal of 
improving health outcomes and decreasing health costs for chronic care 
conditions.
    (b) Models To Test Efficacy of Synchronization.--
            (1) In general.--The model described in this subsection 
        shall test the efficacy of synchronization of prescription drug 
        medications for applicable enrollees in improving medication 
        adherence, determining cost avoidance, and improving outcomes 
        for those enrollees.
            (2) Participation.--An applicable enrollee who is eligible 
        to participate in the model testing under this subsection shall 
        participate in the model testing, unless the enrollee elects 
        not to participate in the model.
            (3) Models tested.--The following models of synchronization 
        shall be tested under this subsection:
                    (A) Model 1.--Synchronization (synchronization of 
                prescription drug medications and medication 
                reconciliation phone calls or electronic communication 
                with enrollees prior to filling prescriptions).
                    (B) Model 2.--Synchronization (as described in 
                subparagraph (A)) and compliance-based packaging.
                    (C) Model 3.--Synchronization (as described in 
                subparagraph (A)) and ongoing pharmacist counseling 
                that shall occur at the patient's request and include 
                review of the appropriateness of the medication regimen 
                and any barriers to medication adherence.
            (4) Evaluation.--The Secretary shall evaluate the models in 
        paragraph (3) by collecting and analyzing relevant plan and 
        enrollee data, including at least the following:
                    (A) Synchronization enrollment and drop-out rates.
                    (B) Primary medication nonadherence.
                    (C) Medication adherence and persistence rates.
                    (D) Demographic characteristics of applicable 
                enrollees.
                    (E) Plan characteristics, such as plan benefit 
                design.
                    (F) Impact of the models on applicable enrollees 
                who are--
                            (i) eligible for benefits under a State 
                        plan under title XIX of the Social Security; or
                            (ii) eligible for premium and cost-sharing 
                        subsidies under section 1860D-14(a) of the 
                        Social Security Act (42 U.S.C. 1395w-114(a)).
                    (G) Prescription drug claims data in comparison to 
                other medical claims data for applicable enrollees in 
                order to examine the effect of synchronization and 
                adherence on overall health spending, including health 
                care costs avoided, and patient outcomes.
    (c) Testing 90-Day Fills at Retail Pharmacies for the First 
Prescription.--
            (1) In general.--The Secretary shall conduct a 
        demonstration that compares the use of 90-day first fills of 
        prescriptions at retail pharmacies or using mail-order for 
        maintenance medications against 30-day first fills for 
        applicable enrollees under part D of title XVIII of the Social 
        Security Act, to determine whether there is an impact on 
        medication persistence, cost avoidance, and improving outcomes 
        for those enrollees in subsequent refill periods.
            (2) Drugs tested.--The model under this subsection shall 
        only pertain to first fills for maintenance drugs treating 
        chronic diseases such as cardiovascular disease, hypertension, 
        diabetes, autoimmune diseases, chronic obstructive pulmonary 
        disease (COPD), and mental health conditions.
            (3) Evaluation of demonstration by gao.--
                    (A) Provision of data for evaluation.--The 
                Secretary shall make available to the Comptroller 
                General of the United States relevant plan and enrollee 
                data in order to enable an evaluation of the 
                demonstration under this subsection under subparagraph 
                (B).
                    (B) Evaluation.--Using data made available under 
                subparagraph (A) and other relevant data, the 
                Comptroller General of the United States shall evaluate 
                the demonstration conducted under this subsection. Such 
                evaluation shall examine the effect of long-term fills 
                and adherence on overall health spending, including 
                health care costs avoided, and patient outcome, and 
                shall examine at least the following in relation to 
                part D enrollees using 90-day first fills in comparison 
                with those enrollees using 30-day first fills:
                            (i) Medication adherence and persistence 
                        rates.
                            (ii) Cost differentials in pharmacy costs.
                            (iii) Prescription drug claims data in 
                        comparison to other medical claims.
                            (iv) Medication wastage (as defined in 
                        section 3).
                    (C) Report.--The Comptroller General shall submit a 
                report to the Secretary and Congress on the evaluation 
                conducted under this paragraph.
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