II 

114TH CONGRESS 

2D SESSION S. 3454 

To improve medication adherence. 

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 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. FINDINGS. 

4 Congress makes the following findings: 

5 (1) Eighty to ninety percent of the means by 

6 which we prevent and control chronic disease is with 

7 medications. Assuring the most appropriate and ef8 fective medications are used to optimize patient out9 comes is a national priority. The ability of patients 

10 to then adhere to the medication regimen becomes 

11 vital. 


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(2) Between 1⁄2 and 2 1 ⁄3 of individuals with 

2 chronic diseases in the United States do not take 

3 medications as prescribed. 

4 (3) Suboptimal medication use, including un5 treated indications (such as failure to immunize), 

6 over or under dosing of medications, safety issues, 

7 and low rates of medication adherence result in 

8 higher health care costs, reduced effectiveness of 

9 health care treatments and regimes, negative health 

10 effects for patients, and tens of thousands of deaths 

11 on an annual basis. 

12 (4) Appropriate medication use and adherence 

13 may be lowest among individuals with chronic dis14 eases. 

15 (5) Improving medication adherence would re16 duce unnecessary hospital admissions and emergency 

17 room visits. 

18 (6) Drug therapy problems including underuse 

19 and nonadherence is estimated to cost the healthcare 

20 system in the United States over $290,000,000,000 

21 each year. 

22 (7) Improving appropriate medication adher23 ence could improve patient health outcomes, reduce 

24 health care costs, and lead to productivity gains. 


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1 SEC. 2. NATIONAL RESEARCH AND REPORTING STRATEGY 

2 FOR IMPROVED MEDICATION ADHERENCE. 

3 Part A of title III of the Public Health Service Act 

4 (42 U.S.C. 341 et seq.) is amended by adding at the end 

5 the following: 

6 ‘‘SEC. 310B. NATIONAL RESEARCH AND REPORTING STRAT7 EGY FOR IMPROVED MEDICATION ADHER8 ENCE. 

9 ‘‘(a) IN GENERAL.—The Secretary, in coordination 

10 with the Administrator of the Agency for Healthcare Re11 search and Quality, the Administrator of the Centers for 

12 Medicare & Medicaid Services, and the Director of the 

13 Centers for Disease Control and Prevention, shall report 

14 annual statistics on medication adherence, particularly 

15 with respect to individuals with chronic diseases such as 

16 cardiovascular disease, hypertension, diabetes, auto17 immune diseases, chronic obstructive pulmonary disease, 

18 and mental health conditions, to better inform decision19 makers regarding— 

20 ‘‘(1) primary nonadherence, including among 

21 patients newly prescribed one or more medications 

22 at the time of discharge from an acute care setting; 

23 ‘‘(2) medication persistence; 

24 ‘‘(3) related quality measures with respect to 

25 medication and methods to improve medication ad26 herence and medication persistence; and 


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1 ‘‘(4) the strategies used by private stakeholders 

2 to improve medication adherence among individuals 

3 with one or more chronic illnesses. 

4 ‘‘(b) FEDERAL HEALTH CARE PROGRAMS.—The re5 search conducted, and information and statistics devel6 oped, under subsection (a) (other than paragraph (6) of 

7 such subsection) shall be with respect to individuals treat8 ed under the following health care programs: 

9 ‘‘(1) The Medicare program under title XVIII 

10 of the Social Security Act. 

11 ‘‘(2) The Medicaid program under title XIX of 

12 the Social Security Act. 

13 ‘‘(3) The Federal Employees Health Benefits 

14 Plan under chapter 89 of title 5, United States 

15 Code. 

16 ‘‘(4) The TRICARE program under chapter 55 

17 of title 10, United States Code. 

18 ‘‘(5) Hospital care and medical services fur19 nished by the Department of Veterans Affairs under 

20 chapters 17 and 18 of title 38, United States Code. 

21 ‘‘(c) DEFINITIONS.—In this section: 

22 ‘‘(1) The term ‘medication adherence’ means a 

23 patient taking medications as prescribed by their 

24 health care provider, which may include the pre25 scribed dosage, time, frequency, and direction. 


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1 ‘‘(2) The term ‘medication persistence’ means 

2 the act of continuing treatment with a medication 

3 for the prescribed duration. 

4 ‘‘(3) The term ‘primary nonadherence’ means 

5 the failure to fill a newly prescribed medication. 

6 ‘‘(4) The term ‘medication management’ means 

7 medical care provided by a health care professional 

8 to optimize drug therapy and improve therapeutic 

9 outcomes for patients, including medication therapy 

10 management. 

11 ‘‘(d) REPORTS TO CONGRESS.—The Secretary shall 

12 submit to Congress an initial report on the research con13 ducted under this section not later than 1 year after the 

14 date of enactment of this section, and an updated report 

15 not later than 5 years after submission of such initial re16 port.’’. 

17 SEC. 3. LINKING MEDICARE PRESCRIPTION DRUG AND 

18 PARTS A AND B CLAIMS DATA. 

19 Section 1860D–4(c) of the Social Security Act (42 

20 U.S.C. 1395w–104(c)) is amended by adding at the end 

21 the following new paragraph: 

22 ‘‘(5) LINKING PRESCRIPTION DRUG AND PARTS

23 A AND B CLAIMS DATA.— 

24 ‘‘(A) IN GENERAL.—Notwithstanding any 

25 other provision of law, subject to subparagraph 


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1 (B), effective for plan year 2018 and each sub2 sequent plan year, the Secretary shall, upon re3 quest by the PDP sponsor of a prescription 

4 drug plan, provide the plan with enrollee claims 

5 data under parts A and B, in order to enable 

6 the plan to see the items and services furnished 

7 to an enrollee under such parts and to provide 

8 greater context for the medication regimen of 

9 the enrollee. 

10 ‘‘(B) REQUIREMENTS.—The data de11 scribed in subparagraph (A) shall, as deter12 mined by the Secretary, be provided to a pre13 scription drug plan on a regular basis and in a 

14 format that is computable and accessible to as15 sist plan efforts in identifying and supporting 

16 at-risk enrollees.’’. 

17 SEC. 4. RECOGNIZING MEDICATION MANAGEMENT IM18 PROVES QUALITY UNDER MEDICARE ADVAN19 TAGE AND PRESCRIPTION DRUG PLANS. 

20 Section 1857(e) of the Social Security Act is amend21 ed— 

22 (1) in paragraph (4), by striking ‘‘If the Sec23 retary’’ and inserting ‘‘Subject to paragraph (5), if 

24 the Secretary’’; and 


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1 (2) by adding at the end the following new 

2 paragraph: 

3 ‘‘(5) RECOGNIZING MEDICATION MANAGEMENT

4 IMPROVES QUALITY.—For purposes of calculating 

5 the minimum medical loss ratio under paragraph (4) 

6 for a contract year (beginning with 2018), the Sec7 retary shall include medication management (as de8 fined in section 310B(c) of the Public Health Serv9 ice Act) as part of activities that improve health care 

10 quality (as described with respect to Medicare Ad11 vantage plans and prescription drug plans in sec12 tions 422.2430 and 423.2430, respectively, of title 

13 42, Code of Federal Regulations (or in any successor 

14 regulation)).’’. 

15 SEC. 5. ENHANCED MEDICATION THERAPY MANAGEMENT 

16 MODEL FOR MA–PD PLANS. 

17 Section 1115A(b)(2) of the Social Security Act (42 

18 U.S.C. 1315a(b)(2)) is amended— 

19 (1) in subparagraph (A), by adding at the end 

20 the following new sentence: ‘‘The models selected 

21 under this subparagraph shall include the model de22 scribed in subparagraph (D), which shall be imple23 mented by not later than the date that is 1 year 

24 after the implementation of the Part D Enhanced 

25 Medication Therapy Management Model, as conVerDate Sep 11 2014 23:35 Oct 04, 2016 Jkt 069200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S3454.IS S3454

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1 ducted by the Centers for Medicare & Medicaid 

2 Services with respect to stand-alone basic prescrip3 tion drug plans.’’; and 

4 (2) by adding at the end the following new sub5 paragraph: 

6 ‘‘(D) ENHANCED MEDICATION THERAPY

7 MANAGEMENT FOR MA–PD PLANS.— 

8 ‘‘(i) IN GENERAL.—Subject to clause 

9 (ii), the model described in this subpara10 graph is a model to test, with respect to 

11 MA–PD plans (as defined in section 

12 1860D–1(a)(3)(C)), a model for enhanced 

13 medication therapy management that is 

14 similar to the Part D Enhanced Medica15 tion Therapy Management Model, as con16 ducted by the Centers for Medicare & Med17 icaid Services with respect to stand-alone 

18 basic prescription drug plans. 

19 ‘‘(ii) NO ADDITIONAL PERFORMANCE

20 PAYMENT.—Under the model described in 

21 this subparagraph, an MA–PD plan (as so 

22 defined) shall not receive any additional 

23 performance payment (other than any ap24 plicable percentage quality increase otherVerDate Sep 11 2014 23:35 Oct 04, 2016 Jkt 069200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S3454.IS S3454

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1 wise applicable for the plan under section 

2 1853(o)).’’. 

Æ 


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