II

103D CONGRESS

2D SESSION S. 2283

To amend title XVIII of the Social Security Act to provide for coverage

of prostate cancer screening and certain drug treatment services under

part B of the medicare program, to amend chapter 17 of title 38,

United States Code, to provide for coverage of such screening and services under the programs of the Department of Veterans Affairs, and

to expand research and education programs of the National Institutes

of Health and the Public Health Service relating to prostate cancer.

IN THE SENATE OF THE UNITED STATES

JULY 14 (legislative day, JULY 11), 1994

Mr. SHELBY (for himself, Mr. THURMOND, Mr. REID, and Mr. STEVENS) 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 provide

for coverage of prostate cancer screening and certain

drug treatment services under part B of the medicare

program, to amend chapter 17 of title 38, United States

Code, to provide for coverage of such screening and

services under the programs of the Department of Veterans Affairs, and to expand research and education programs of the National Institutes of Health and the Public Health Service relating to prostate cancer.

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 ‘‘Prostate Cancer Diag3 nosis and Treatment Act of 1994’’.

4 SEC. 2. MEDICARE COVERAGE OF PROSTATE CANCER

5 SCREENING AND CERTAIN DRUG TREAT6 MENTS.

7 (a) COVERAGE OF SCREENING SERVICES.—

8 (1) IN GENERAL.—Section 1861(s)(2) of the

9 Social Security Act (42 U.S.C. 1395x(s)(2)), as

10 amended by section 13553(a) of the Omnibus Budg11 et Reconciliation Act of 1993 (hereafter in this Act

12 referred to as ‘‘OBRA–1993’’), is amended—

13 (A) by striking ‘‘and’’ at the end of sub14 paragraph (P);

15 (B) by adding ‘‘and’’ at the end of sub16 paragraph (Q); and

17 (C) by adding at the end the following new

18 subparagraph:

19 ‘‘(R) prostate cancer screening services (as de20 fined in subsection (ll));’’.

21 (2) SERVICES DESCRIBED.—Section 1861 of

22 such Act (42 U.S.C. 1395x) is amended—

23 (A) by redesignating the subsection (jj) in24 serted by section 4156(a)(2) of the Omnibus

25 Budget Reconciliation Act of 1990 as sub26 section (kk); and
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1 (B) by inserting after such subsection the

2 following new subsection:

3 ‘‘Prostate Cancer Screening Services

4 ‘‘(ll) The term ‘prostate cancer screening services’

5 means the following procedures provided to a man for the

6 purpose of early detection of prostate cancer:

7 ‘‘(1) Digital rectal examination.

8 ‘‘(2) Prostate-specific antigen blood test.

9 ‘‘(3) Transrectal ultrasonography.

10 ‘‘(4) Such other procedures as the Secretary

11 may designate as appropriate for early detection of

12 prostate cancer.’’.

13 (3) PAYMENT AMOUNTS; LIMITATIONS ON FRE14 QUENCY OF COVERAGE.—Section 1834 of such Act

15 (42 U.S.C. 1395m) is amended by inserting after

16 subsection (c) the following new subsection:

17 ‘‘(d) PAYMENT AMOUNTS AND FREQUENCY LIMITS

18 FOR PROSTATE CANCER SCREENING SERVICES.—

19 ‘‘(1) IN GENERAL.—Notwithstanding any other

20 provision of this part, with respect to expenses in21 curred for prostate cancer screening services (as de22 fined in section 1861(ll))—

23 ‘‘(A) payment may be made only for serv24 ices provided consistent with the frequency per25 mitted under paragraph (2); and
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1 ‘‘(B) the amount of the payment under

2 this part shall be equal to 80 percent of the

3 lesser of the actual charge for the service or—

4 ‘‘(i) in the case of a prostate cancer

5 screening service consisting of a prostate6 specific antigen blood test, the fee schedule

7 amount established for the service under

8 section 1833(h) (relating to payments for

9 clinical diagnostic laboratory tests); or

10 ‘‘(ii) in the case of any other prostate

11 cancer screening service, the amount pro12 vided under the fee schedule established by

13 the Secretary under paragraph (3) (subject

14 to the deductible established under section

15 1833(b)).

16 ‘‘(2) FREQUENCY COVERED.—

17 ‘‘(A) IN GENERAL.—Subject to subpara18 graph (B) and to revision by the Secretary

19 under subparagraph (C), no payment may be

20 made under this part for a prostate cancer

21 screening service provided to an individual for

22 the purpose of early detection of prostate can23 cer—

24 ‘‘(i) if the individual is under 50 years

25 of age; or
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1 ‘‘(ii) if the service is provided within

2 the 11 months after a previous prostate

3 cancer screening service.

4 ‘‘(B) EXCEPTION FOR HIGH RISK INDIVID5 UALS.—Payment may be made under this part

6 for a prostate cancer screening service provided

7 to an individual more frequently than the limit

8 established under subparagraph (A)(ii) if the

9 individual is at a high risk of developing pros10 tate cancer (as determined pursuant to factors

11 identified by the Secretary).

12 ‘‘(C) REVISION BY SECRETARY.—

13 ‘‘(i) REVIEW.—The Secretary, in con14 sultation with the Director of the National

15 Cancer Institute, shall review periodically

16 the appropriate frequency for performing

17 prostate cancer screening services based on

18 age and such other factors as the Sec19 retary believes to be pertinent.

20 ‘‘(ii) REVISION OF FREQUENCY.—The

21 Secretary, taking into consideration the re22 view made under clause (i), may revise

23 from time to time the frequency with

24 which such services may be paid for under

25 this subsection, but no such revision shall
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1 apply to services performed before January

2 1, 1998.

3 ‘‘(3) ESTABLISHMENT OF FEE SCHEDULE.—

4 ‘‘(A) IN GENERAL.—The Secretary shall

5 establish fee schedules (on such geographic

6 basis as the Secretary considers appropriate)

7 for payment for prostate cancer screening serv8 ices under this part (other than prostate-spe9 cific antigen blood tests), effective for services

10 furnished after the expiration of the 90-day pe11 riod beginning on the date the Secretary estab12 lishes the fee schedules.

13 ‘‘(B) FACTORS CONSIDERED.—In estab14 lishing fee schedules under subparagraph (A),

15 the Secretary shall take into consideration vari16 ations in the cost of furnishing such services

17 among geographic areas and among different

18 sites where services are furnished, together with

19 such other factors as may be appropriate to as20 sure that payment amounts are equitable.

21 ‘‘(4) LIMITING CHARGES OF NONPARTICIPATING

22 PHYSICIANS.—

23 ‘‘(A) IN GENERAL.—In the case of a pros24 tate cancer screening service provided to an in25 dividual for the purpose of early detection of
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1 prostate cancer for which payment may be

2 made under this part, if a nonparticipating phy3 sician or supplier provides the procedure to an

4 individual enrolled under this part, the physi5 cian or supplier may not charge the individual

6 more than the limiting charge (as defined in

7 section 1848(g)(2)).

8 ‘‘(B) ENFORCEMENT.—If a physician or

9 supplier knowingly and willfully imposes a

10 charge in violation of subparagraph (A), the

11 Secretary may apply sanctions against such

12 physician or supplier in accordance with section

13 1842(j)(2).’’.

14 (4) CONFORMING AMENDMENTS.—(A) Para15 graphs (1)(D) and (2)(D) of section 1833(a) of such

16 Act (42 U.S.C. 1395l(a)) are each amended by strik17 ing ‘‘subsection (h)(1),’’ and inserting ‘‘subsection

18 (h)(1) or section 1834(d)(1)(B)(i),’’.

19 (B) Section 1833(a)(1) of such Act (42 U.S.C.

20 1395l(a)(1)), as amended by section 13544(b)(2) of

21 OBRA–1993, is amended—

22 (i) by striking ‘‘and (P)’’ and inserting

23 ‘‘(P)’’; and

24 (ii) by striking the semicolon at the end

25 and inserting the following: ‘‘, and (Q) with re-
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1 spect to prostate cancer screening services (as

2 defined in section 1861(ll)) (other than pros3 tate-specific antigen tests), the amounts paid

4 shall be the amounts described in section

5 1834(d)(1);’’.

6 (C) Section 1833(a) of such Act (42 U.S.C.

7 1395l(a)) is amended—

8 (i) by striking ‘‘and’’ at the end of para9 graph (6);

10 (ii) by striking the period at the end of

11 paragraph (7) and inserting ‘‘; and’’; and

12 (iii) by adding at the end the following new

13 paragraph:

14 ‘‘(8) in the case of prostate cancer screening

15 services (as defined in section 1861(ll)) (other than

16 prostate-specific antigen tests), the amounts de17 scribed in section 1834(d)(1).’’.

18 (D) Section 1833(h)(1)(A) of such Act (42

19 U.S.C. 1395l(h)(1)(A)) is amended by striking ‘‘The

20 Secretary’’ and inserting ‘‘Subject to section

21 1834(d), the Secretary’’.

22 (E) Section 1861(s)(2)(O) of such Act (42

23 U.S.C. 1395x(s)(2)(O)) is amended by striking

24 ‘‘(jj)’’ and inserting ‘‘(kk)’’.
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1 (F) Section 1862(a) of such Act (42 U.S.C.

2 1395y(a)) is amended—

3 (i) in paragraph (1)—

4 (I) in subparagraph (E), by striking

5 ‘‘and’’ at the end,

6 (II) in subparagraph (F), by striking

7 the semicolon at the end and inserting ‘‘,

8 and’’, and

9 (III) by adding at the end the follow10 ing new subparagraph:

11 ‘‘(G) in the case of prostate cancer screening

12 services (as defined in section 1861(ll)) provided for

13 the purpose of early detection of prostate cancer,

14 which are performed more frequently than is covered

15 under section 1834(d)(2);’’; and

16 (ii) in paragraph (7), by striking ‘‘para17 graph (1)(B) or under paragraph (1)(F)’’ and

18 inserting ‘‘subparagraphs (B), (F), or (G) of

19 paragraph (1)’’.

20 (b) COVERAGE OF CERTAIN DRUG TREATMENTS.—

21 Section 1861(s)(2) of the Social Security Act (42 U.S.C.

22 1395x(s)(2)), as amended by subsection (a)(1), is further

23 amended—

24 (1) by striking ‘‘and’’ at the end of subpara25 graph (Q);
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1 (2) by adding ‘‘and’’ at the end of subpara2 graph (R); and

3 (3) by adding at the end the following new sub4 paragraph:

5 ‘‘(S) an oral drug prescribed for the treatment

6 of prostate cancer, if the use of the drug for such

7 purpose is a medically accepted indication under

8 subsection (t)(2);’’.

9 (c) EFFECTIVE DATE.—The amendments made by

10 this section shall apply to services provided on or after

11 January 1, 1995, without regard to whether or not the

12 Secretary has established fee schedules under section

13 1834(d)(3) of the Social Security Act (as added by sub14 section (a)(3)) or promulgated other regulations to carry

15 out such amendments by that date.

16 SEC. 3. COVERAGE OF PROSTATE CANCER SCREENING AND

17 TREATMENT SERVICES FOR VETERANS.

18 (a) PROSTATE CANCER SCREENING AND DIAGNOSIS

19 DEFINED AS PREVENTIVE HEALTH SERVICE.—Section

20 1701(9) of title 38, United States Code is amended—

21 (1) by redesignating subparagraphs (J) and (K)

22 as subparagraphs (K) and (L), respectively; and

23 (2) by inserting after subparagraph (I) the fol24 lowing new subparagraph (J):
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1 ‘‘(J) screening and diagnostic tests approved

2 for prostate cancer;’’.

3 (b) COVERAGE OF PROSTATE CANCER SCREENING

4 AND TREATMENT.—

5 (1) IN GENERAL.—Chapter 17 of title 38,

6 United States Code, is amended by inserting after

7 section 1724 a new section as follows:

8 ‘‘§ 1725. Prostate cancer screening and treatment

9 ‘‘(a) The Secretary shall include in the medical serv10 ices made available to veterans under this chapter appro11 priate prostate cancer screening, counseling, treatment,

12 and information. Based on the best available medical evi13 dence, the Secretary shall develop and implement an ap14 propriate prostate cancer screening schedule for those vet15 erans confined to hospitals or other institutions.

16 ‘‘(b) For the purposes of this section—

17 ‘‘(1) appropriate prostate cancer screening

18 means procedures provided to a man for the purpose

19 of early detection of prostate cancer, including digi20 tal rectal examinations, prostate-specific antigen

21 blood tests, and transrectal ultrasonography; and

22 ‘‘(2) appropriate prostate cancer treatment in23 cludes drugs approved by the Food and Drug Ad24 ministration for the treatment of prostate cancer.
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1 ‘‘(c) The Secretary may carry out research and re2 search training in the diagnosis and treatment of prostate

3 cancer based upon the prostate cancer services provided

4 under this section and may develop guidelines outlining

5 effective treatment regimens for prostate cancer.’’.

6 (2) CLERICAL AMENDMENT.—The table of sec7 tions at the beginning of such chapter is amended

8 by inserting after the item relating to section 1724

9 the following new item:

‘‘1725. Prostate cancer screening and treatment.’’.

10 SEC. 4. RESEARCH AND EDUCATION REGARDING PROS11 TATE CANCER; CERTAIN PROGRAMS OF PUB12 LIC HEALTH SERVICE.

13 (a) NATIONAL INSTITUTES OF HEALTH.—Section

14 417B(c) of the Public Health Service Act (42 U.S.C.

15 286a–8(c)) is amended in the first sentence by striking

16 ‘‘$72,000,000’’ and all that follows and inserting the fol17 lowing: ‘‘$72,000,000 for fiscal year 1994, $86,000,000

18 for fiscal year 1995, $100,000,000 for fiscal year 1996,

19 and such sums as may be necessary for each of the fiscal

20 years 1997 and 1998.’’.

21 (b) AGENCY FOR HEALTH CARE POLICY AND RE22 SEARCH.—Section 902 of the Public Health Service Act

23 (42 U.S.C. 299a) is amended by adding at the end the

24 following subsection:
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1 ‘‘(f) ACTIVITIES REGARDING PROSTATE CANCER.—

2 The Administrator shall, with respect to prostate cancer—

3 ‘‘(1) conduct and support research on the out4 comes, effectiveness, and appropriateness of health

5 services and procedures; and

6 ‘‘(2) in carrying out section 912(a), provide for

7 the development, periodic review, and updating of

8 clinically relevant guidelines, standards of quality,

9 performance measures, and medical review criteria.’’.

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