I

104TH CONGRESS

1ST SESSION H. R. 2839

To amend title XVIII of the Social Security Act to establish a medication

evaluation and dispensing system for Medicare beneficiaries, to improve

the quality of pharmaceutical services received by our Nation’s elderly

and disabled, and to reduce instances of adverse reactions to prescription

drugs experienced by Medicare beneficiaries.

IN THE HOUSE OF REPRESENTATIVES

DECEMBER 22, 1995

Mr. STARK introduced the following bill; which was referred to the Committee

on Ways and Means, and in addition to the Committee on Commerce,

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 title XVIII of the Social Security Act to establish

a medication evaluation and dispensing system for Medicare beneficiaries, to improve the quality of pharmaceutical services received by our Nation’s elderly and

disabled, and to reduce instances of adverse reactions

to prescription drugs experienced by Medicare

beneficiaries.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,
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1 SECTION 1. SHORT TITLE.

2 This Act may be cited as the ‘‘Medicare Medication

3 Evaluation and Dispensing System Act of 1995’’.

4 SEC. 2. ESTABLISHMENT OF MEDICATION EVALUATION

5 AND DISPENSING SYSTEM UNDER MEDICARE.

6 (a) IN GENERAL.—Title XVIII of the Social Security

7 Act (42 U.S.C. 1395 et seq.) is amended by inserting after

8 section 1888 the following new section:

9 ‘‘MEDICARE MEDICATION EVALUATION AND DISPENSING

10 SYSTEM

11 ‘‘SEC. 1889. (a) ESTABLISHMENT.—

12 ‘‘(1) IN GENERAL.—In accordance with the re13 quirements of this section, the Secretary shall estab14 lish and operate the Medicare Medication Evaluation

15 and Dispensing System (hereafter in this section re16 ferred to as the ‘MMEDS’) to provide for—

17 ‘‘(A) prospective and retrospective review

18 of prescription drugs furnished to Medicare

19 beneficiaries (in accordance with subsection

20 (b));

21 ‘‘(B) educating physicians, patients, and

22 pharmacists regarding the appropriate use of

23 prescription drugs (in accordance with sub24 section (c)); and

25 ‘‘(C) the establishment of standards for

26 counseling Medicare beneficiaries (consistent
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1 with the laws of the State in which a bene2 ficiary resides) regarding the appropriate use of

3 prescription drugs.

4 ‘‘(2) TREATMENT OF DRUGS NOT COVERED

5 UNDER MEDICARE.—The MMEDS shall provide for

6 review, information, and counseling with respect to

7 any prescription drug furnished to a Medicare bene8 ficiary without regard to whether or not payment

9 may be made for the drug under this title.

10 ‘‘(3) MEDICARE BENEFICIARY DEFINED.—In

11 this section, a ‘Medicare beneficiary’ is any individ12 ual entitled to benefits under part A or enrolled

13 under part B.

14 ‘‘(b) REQUIREMENTS FOR REVIEW OF PRESCRIP15 TIONS.—

16 ‘‘(1) IN GENERAL.—The MMEDS shall provide

17 on-line prospective review of prescriptions on a 24-

18 hour basis and periodic retrospective review of

19 claims.

20 ‘‘(2) PROSPECTIVE DRUG UTILIZATION RE21 VIEW.—

22 ‘‘(A) IN GENERAL.—The MMEDS shall

23 provide for on-line prospective review of each

24 outpatient prescription drug prescribed for a

25 Medicare beneficiary before the prescription is
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1 filled or the drug is furnished, including screen2 ing for potential drug therapy problems due to

3 therapeutic duplication, drug-to-drug inter4 actions, drug-disease contraindications, and in5 correct drug dosage or duration of drug treat6 ment.

7 ‘‘(B) DISCUSSION OF APPROPRIATE USE.—

8 In conducting prospective review under the

9 MMEDS, any individual or entity that dis10 penses an outpatient prescription drug shall

11 offer (consistent with the law of the State in

12 which the patient resides) to discuss with the

13 patient to whom the drug is furnished or the

14 patient’s caregiver (in person if practicable, or

15 through access to a toll-free telephone service)

16 information regarding the appropriate use of

17 the drug, potential interactions between the

18 drug and other drugs dispensed to the individ19 ual, and such other matters as the Secretary

20 may require.

21 ‘‘(C) ADDITIONAL DUTIES.—In carrying

22 out this paragraph, the Secretary shall—

23 ‘‘(i) develop public domain software

24 which could be used by carriers and phar-
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1 macies to provide the on-line prospective

2 review; and

3 ‘‘(ii) study the feasibility and desir4 ability of requiring patient diagnosis codes

5 on prescriptions and the feasibility of ex6 panding the prospective drug utilization re7 view program to include the identification

8 of drug-disease contraindications, inter9 actions with over-the-counter drugs, and

10 drug-allergy interactions.

11 ‘‘(3) RETROSPECTIVE DRUG UTILIZATION RE12 VIEW.—As part of the MMEDS, the Secretary shall

13 provide for a retrospective drug utilization review

14 program to provide for the ongoing periodic exam15 ination of claims data and other records on out16 patient prescription drugs furnished to Medicare

17 beneficiaries in order to identify patterns of inappro18 priate or medically unnecessary patient care.

19 ‘‘(4) USE OF ELECTRONIC SYSTEM.—

20 ‘‘(A) IN GENERAL.—As part of the

21 MMEDS, the Secretary shall establish, by not

22 later than June 1, 1997, a point-of-sale elec23 tronic system for use by carriers and phar24 macies in the submission of information re25 specting outpatient prescription drugs dis-
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1 pensed to Medicare beneficiaries. Such system

2 shall be consistent with the standards estab3 lished by the National Council of Prescription

4 Drug Programs.

5 ‘‘(B) TECHNICAL ASSISTANCE.—The Sec6 retary shall provide technical assistance in the

7 use of the electronic system established under

8 subparagraph (A) to carriers and pharmacies.

9 ‘‘(c) EDUCATION REGARDING APPROPRIATE USE OF

10 PRESCRIPTION DRUGS.—

11 ‘‘(1) IN GENERAL.—Under the MMEDS, the

12 Secretary (either directly or through contract) shall

13 provide for an educational outreach program to edu14 cate patients, pharmacists, and other health care

15 providers concerning—

16 ‘‘(A) instances or patterns of unnecessary

17 or inappropriate prescribing or dispensing prac18 tices for outpatient prescription drugs,

19 ‘‘(B) instances or patterns of substandard

20 care with respect to such drugs,

21 ‘‘(C) potential adverse reactions and inter22 actions, and

23 ‘‘(D) appropriate use of generic products.

24 ‘‘(2) INFORMATION ON CHANGES IN PRESCRIB25 ING AND DISPENSING PRACTICES.—Under the pro-
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1 gram described in paragraph (1), the Secretary shall

2 provide information (in such format as the Secretary

3 considers appropriate) on changes in prescribing and

4 dispensing practices to promote the appropriate use

5 of prescription drugs.

6 ‘‘(d) PRIVACY PROTECTION.—The Secretary shall es7 tablish standards to protect from public disclosure any in8 formation provided by or through the MMEDS that identi9 fies an individual and relates to the individual’s physical

10 or mental health and the identity of any individual (wheth11 er a patient or an individual involved in the prescribing,

12 dispensing, or administration of the drug) who is the sub13 ject of such information.

14 ‘‘(e) ASSISTANCE FOR PARTICIPATING PHAR15 MACISTS.—

16 ‘‘(1) IN GENERAL.—The Secretary shall provide

17 to each pharmacist meeting the requirements of

18 paragraph (2)—

19 ‘‘(A) a distinctive emblem (suitable for dis20 play to the public) indicating that the pharmacy

21 participates in the MMEDS, and

22 ‘‘(B) upon request, such technical assist23 ance as the Secretary determines may be nec24 essary for the pharmacist to submit information
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1 to and retrieve information from the electronic

2 system established under subsection (b)(4).

3 ‘‘(2) REQUIREMENTS DESCRIBED.—A phar4 macist meets the requirements of this paragraph if

5 the pharmacist is legally authorized under State law

6 (or the State regulatory mechanism provided by

7 State law) of the State in which the drug is received

8 by the beneficiary to dispense outpatient prescription

9 drugs and meets other participation standards estab10 lished by the Secretary with respect to the following:

11 ‘‘(A) Maintenance of patient records.

12 ‘‘(B) Accuracy of information submitted

13 under the MMEDS.

14 ‘‘(C) Patient counseling.

15 ‘‘(D) Performance of drug use review ac16 tivities under the MMEDS.

17 ‘‘(f) ADOPTION OF MEDICAID PROGRAMS.—To the

18 extent considered appropriate by the Secretary, the

19 MMEDS with respect to drugs furnished in a State may

20 include elements applicable to the furnishing of covered

21 outpatient drugs under the State Medicaid program under

22 section 1927.’’.

23 (b) RECOMMENDATIONS ON COORDINATION WITH

24 PROGRAMS UNDER OTHER PLANS.—Not later than Octo-
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1 ber 1, 1996, the Secretary of Health and Human Services

2 shall submit recommendations to Congress on measures—

3 (1) to ensure the coordination of information

4 collected and disseminated under the Medicare Medi5 cation Evaluation and Dispensing System estab6 lished under section 1889 of the Social Security Act

7 (as added by subsection (a)) with information pro8 vided to and collected from similar programs provid9 ing services to Medicare beneficiaries enrolled in

10 health care plans (including plans of an organization

11 described in section 1833(a)(1)(A) of such Act or an

12 eligible organization with an agreement in effect

13 under section 1876 of such Act, plans serving as pri14 mary plans section 1862(b) of such Act, and medi15 care supplemental policies described in section 1882

16 of such Act); and

17 (2) to avoid the duplication of services provided

18 under such System with services provided under

19 such similar programs.

20 (c) SPECIAL RULES FOR CARRIERS.—

21 (1) USE OF REGIONAL CARRIERS.—Section

22 1842(b)(2) of the Social Security Act (42 U.S.C.

23 1395u(b)(2)) is amended by adding at the end the

24 following new subparagraph:
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1 ‘‘(E) With respect to activities related to the Medi2 care Medication Evaluation and Dispensing System under

3 section 1889, the Secretary may enter into contracts with

4 carriers under this section to perform the activities on a

5 regional basis.’’.

6 (2) ADDITIONAL FUNCTIONS.—Section

7 1842(b)(3) of such Act (42 U.S.C. 1395u(b)(3)) is

8 amended—

9 (A) by striking ‘‘and’’ at the end of sub10 paragraph (I); and

11 (B) by inserting after subparagraph (I) the

12 following new subparagraphs:

13 ‘‘(J) if it makes determinations with respect to

14 outpatient prescription drugs which are subject to

15 the Medicare Medication Evaluation and Dispensing

16 System under section 1889, will receive information

17 transmitted under the electronic system established

18 under section 1889(b)(4);

19 ‘‘(K) will enter into such contracts with organi20 zations described in subsection (f)(3) as the Sec21 retary determines may be necessary to implement

22 and operate (and for related functions with respect

23 to) the electronic system established under section

24 1889(b)(4); and’’.
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1 (3) PAYMENT ON OTHER THAN A COST

2 BASIS.—Section 1842(c)(1)(A) of such Act (42

3 U.S.C. 1395u(c)(1)(A)) is amended—

4 (A) by inserting ‘‘(A)’’ after ‘‘(c)(1)’’,

5 (B) in the first sentence, by inserting ‘‘,

6 except as otherwise provided in subparagraph

7 (B),’’ after ‘‘under this part, and’’, and

8 (C) by adding at the end the following:

9 ‘‘(B) To the extent that a contract under this section

10 provides for activities related to the Medicare Medication

11 Evaluation and Dispensing System under section 1889,

12 the Secretary may provide for payment for those activities

13 based on any method of payment determined by the Sec14 retary to be appropriate.’’.

15 (4) USE OF OTHER ENTITIES.—Section 1842(f)

16 of such Act (42 U.S.C. 1395u(f)) is amended—

17 (A) by striking ‘‘and’’ at the end of para18 graph (1),

19 (B) by striking the period at the end of

20 paragraph (2) and inserting ‘‘; and’’, and

21 (C) by adding at the end the following:

22 ‘‘(3) with respect to activities related to the

23 Medicare Medication Evaluation and Dispensing

24 System under section 1889, any other private entity
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1 which the Secretary determines is qualified to con2 duct such activities.’’.

3 SEC. 3. RECOMMENDATIONS ON MEDICARE COVERAGE OF

4 PHARMACIST PROFESSIONAL SERVICES.

5 Not later than the expiration of the 2-year period

6 which begins on the date of the initial operation of the

7 Medicare Medication Evaluation and Dispensing System

8 under section 1889 of the Social Security Act (as added

9 by section 2(a)), the Secretary of Health and Human

10 Services shall submit to Congress (in consultation with ac11 tively practicing pharmacists)—

12 (1) an analysis of the effect on net aggregate

13 expenditures under the Medicare program from the

14 establishment and operation of such System; and

15 (2) such recommendations as the Secretary con16 siders appropriate regarding the coverage of and

17 payment for pharmacist professional services under

18 part B of the medicare program as the Secretary

19 considers appropriate, except that the Secretary may

20 recommend coverage of and payment for such serv21 ices only under a methodology which does not result

22 in an increase in net expenditures under the pro23 gram (taking into account reductions in expendi24 tures under the program as a result of demonstrable
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1 reductions in the inappropriate use of outpatient

2 prescription drugs).

3 SEC. 4. DISTRIBUTION OF CONSUMER GUIDE TO OUT4 PATIENT PRESCRIPTION DRUGS.

5 Not later than January 1, 1997, the Secretary of

6 Health and Human Services shall publish and disseminate

7 a consumer guide to outpatient prescription drugs to as8 sist medicare beneficiaries in reducing expenditures for

9 outpatient prescription drugs and to assist individuals and

10 entities furnishing items and services to such beneficiaries

11 in determining the cost-effectiveness of such drugs.

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