II

104TH CONGRESS

1ST SESSION S. 691

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

of early detection of prostate cancer 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 early detection

and treatment 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

APRIL 6 (legislative day, APRIL 5), 1995

Mr. SHELBY (for himself, Mr. STEVENS, Mr. INOUYE, Mr. THURMOND, Mr.

HEFLIN, and Mr. MACK) 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 early detection of prostate cancer 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

early detection and treatment 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.
2

S 691 IS

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

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Prostate Cancer Diag5 nosis and Treatment Act of 1995’’.

6 SEC. 2. MEDICARE COVERAGE OF EARLY DETECTION OF

7 PROSTATE CANCER AND CERTAIN DRUG

8 TREATMENTS.

9 (a) COVERAGE OF EARLY DETECTION SERVICES.—

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

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

12 amended by section 13553(a) of the Omnibus Budg13 et Reconciliation Act of 1993 (hereafter in this Act

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

15 (A) by striking ‘‘and’’ at the end of sub16 paragraph (P);

17 (B) by adding ‘‘and’’ at the end of sub18 paragraph (Q); and

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

20 subparagraph: ‘‘(R) services for early detection

21 of prostate cancer (as defined in subsection

22 (ll));’’.

23 (2) SERVICES DESCRIBED.—Section 1861 of

24 such Act (42 U.S.C. 1395x) is amended—
3

S 691 IS

1 (A) by redesignating the subsection (jj) in2 serted by section 4156(a)(2) of the Omnibus

3 Budget Reconciliation Act of 1990 as sub4 section (kk); and

5 (B) by inserting after such subsection the

6 following new subsection:

7 ‘‘Services for Early Detection of Prostate Cancer

8 ‘‘(ll) The term ‘services for early detection of prostate

9 cancer’ means the following procedures provided to a man

10 for the purpose of early detection of prostate cancer:

11 ‘‘(1) Digital rectal examination.

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

13 ‘‘(3) Transrectal ultrasonography.

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

15 may designate as appropriate for early detection of

16 prostate cancer.’’.

17 (3) PAYMENT AMOUNTS; LIMITATIONS ON FRE18 QUENCY OF COVERAGE.—Section 1834 of such Act

19 (42 U.S.C. 1395m) is amended by inserting after

20 subsection (c) the following new subsection:

21 ‘‘(d) PAYMENT AMOUNTS AND FREQUENCY LIMITS

22 FOR SERVICES FOR EARLY DETECTION OF PROSTATE

23 CANCER.—

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

25 provision of this part, with respect to expenses in-
4

S 691 IS

1 curred for services for early detection of prostate

2 cancer (as defined in section 1861(ll))—

3 ‘‘(A) payment may be made only for serv4 ices provided consistent with the frequency per5 mitted under paragraph (2); and

6 ‘‘(B) the amount of the payment under

7 this part shall be equal to 80 percent of the

8 lesser of the actual charge for the service or—

9 ‘‘(i) in the case of services for early

10 detection of prostate cancer consisting of a

11 prostate-specific antigen blood test, the fee

12 schedule amount established for the service

13 under section 1833(h) (relating to pay14 ments for clinical diagnostic laboratory

15 tests); or

16 ‘‘(ii) in the case of any other services

17 for early detection of prostate cancer, the

18 amount provided under the fee schedule es19 tablished by the Secretary under para20 graph (3) (subject to the deductible estab21 lished under section 1833(b)).

22 ‘‘(2) FREQUENCY COVERED.—

23 ‘‘(A) IN GENERAL.—Subject to subpara24 graph (B) and to revision by the Secretary

25 under subparagraph (C), no payment may be
5

S 691 IS

1 made under this part for a service provided to

2 an individual for the purpose of early detection

3 of prostate cancer—

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

5 of age; or

6 ‘‘(ii) if the service is provided within

7 the 11 months after a previous prostate

8 cancer detection service.

9 ‘‘(B) EXCEPTION FOR HIGH RISK INDIVID10 UALS.—payment may be made under this part

11 for a service for early detection of prostate can12 cer provided to an individual more frequently

13 than the limit established under subparagraph

14 (A)(ii) if the individual is at a high risk of de15 veloping prostate cancer (as determined pursu16 ant to factors identified by the Secretary).

17 ‘‘(C) REVISION BY SECRETARY.—

18 ‘‘(i) REVIEW.—The Secretary, in con19 sultation with the Director of the National

20 Cancer Institute, shall review periodically

21 the appropriate frequency for performing

22 services for early detection of prostate can23 cer based on age and such other factors as

24 the Secretary believes to be pertinent.
6

S 691 IS

1 ‘‘(ii) REVISION OF FREQUENCY.—The

2 Secretary, taking into consideration the re3 view made under clause (i), may revise

4 from time to time the frequency with

5 which such services may be paid for under

6 this subsection, but no such revision shall

7 apply to services performed before January

8 1, 1998.

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

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

11 establish fee schedules (on such geographic

12 basis as the Secretary considers appropriate)

13 for payment for services for early detection of

14 prostate cancer under this part (other than

15 prostate-specific antigen blood tests), effective

16 for services furnished after the expiration of the

17 90-day period beginning on the date the Sec18 retary establishes the fee schedules.

19 ‘‘(B) FACTORS CONSIDERED.—In estab20 lishing fee schedules under subparagraph (A),

21 the Secretary shall take into consideration vari22 ations in the cost of furnishing such services

23 among geographic areas and among different

24 sites where services are furnished, together with
7

S 691 IS

1 such other factors as may be appropriate to as2 sure that payment amounts are equitable.

3 ‘‘(4) LIMITING CHARGES OF NONPARTICIPATING

4 PHYSICIANS.—

5 ‘‘(A) IN GENERAL.—In the case of a serv6 ice provided to an individual for the purpose of

7 early detection of prostate cancer for which

8 payment may be made under this part, if a

9 nonparticipating physician or supplier provides

10 the procedure to an individual enrolled under

11 this part, the physician or supplier may not

12 charge the individual more than the limiting

13 charge (as defined in section 1848(g)(2)).

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

15 supplier knowingly and willfully imposes a

16 charge in violation of subparagraph (A), the

17 Secretary may apply sanctions against such

18 physician or supplier in accordance with section

19 1842(j)(2).’’.

20 (4) CONFORMING AMENDMENTS.—(A) Para21 graphs (1)(D) and (2)(D) of section 1833(a) of such

22 Act (42 U.S.C. 13951(a)) are each amended by

23 striking ‘‘subsection (h)(1),’’ and inserting ‘‘sub24 section (h)(1) or section 1834(d)(1)(B)(i),’’.
8

S 691 IS

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

2 13951(a)(1)), as amended by section 13544(b)(2) of

3 OBRA–1993, is amended—

4 (i) by striking ‘‘and (P)’’ and insert ‘‘(P)’’;

5 and

6 (ii) by striking the semicolon at the end

7 and inserting the following: ‘‘, and (Q) with re8 spect to services for early detection of prostate

9 cancer (as defined in section 1861(ll)) (other

10 than prostate-specific antigen tests), the

11 amounts paid shall be the amounts described in

12 section 1834(d)(1);’’.

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

14 13951(a)) is amended—

15 (i) by striking ‘‘and’’ at the end of para16 graph (6);

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

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

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

20 paragraph:

21 ‘‘(8) in the case of services for early detection

22 of prostate cancer (as defined in section 1861(ll))

23 (other than prostate-specific antigen tests), the

24 amounts described in section 1834(d)(1).’’.
9

S 691 IS

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

2 U.S.C. 13951(h)(1)(A)) is amended by striking

3 ‘‘The Secretary’’ and inserting ‘‘Subject to section

4 1834(d), the Secretary’’.

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

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

7 ‘‘(jj)’’ and inserting ‘‘(kk)’’.

8 (F) Section 1862(a) of such Act (42 U.S.C.

9 1395y(a)) is amended—

10 (i) in paragraph (1)—

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

12 ‘‘and’’ at the end,

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

14 the semicolon at the end and inserting ‘‘,

15 and’’, and

16 (III) by adding at the end the follow17 ing new subparagraph:

18 ‘‘(G) In the case of services (as defined in sec19 tion 1861(ll)) provided to an individual for the pur20 pose of early detection of prostate cancer, which are

21 performed more frequently than is covered under

22 section 1834(d)(2);’’; and

23 (ii) in paragraph (7), by striking ‘‘para24 graph (1)(B) or under paragraph (1)(F)’’ and
10

S 691 IS

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

2 paragraph (1)’’.

3 (b) COVERAGE OF CERTAIN DRUG TREATMENTS.—

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

5 1395x(s)(2)), as amended by subsection (a)(1), is further

6 amended—

7 (1) by striking ‘‘and’’ at the end of subpara8 graph (Q);

9 (2) by adding ‘‘and’’ at the end of subpara10 graph (R); and

11 (3) by adding at the end the following new sub12 paragraph:

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

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

15 purpose is a medically accepted indication under

16 subsection (t)(2);’’.

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

18 Section 1 shall apply to services provided on or after Janu19 ary 1, 1996, without regard to whether or not the Sec20 retary has established fee schedules under section

21 1834(d)(3) of the Social Security Act (as added by sub22 section (a)(3)) or promulgated other regulations to carry

23 out such amendments by that date.
11

S 691 IS

1 SEC. 3. COVERAGE OF SERVICES FOR EARLY DETECTION

2 AND TREATMENT OF PROSTATE CANCER IN

3 VETERANS.

4 (a) PROSTATE CANCER EARLY DETECTION AND DI5 AGNOSIS DEFINED AS PREVENTIVE HEALTH SERVICES.—

6 Section 1701(9) of title 38, United States Code is amend7 ed—

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

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

10 (2) by inserting after subparagraph (I) the fol11 lowing new subparagraph (J):

12 ‘‘(J) early detection and diagnostic tests ap13 proved for prostate cancer,’’.

14 (b) COVERAGE OF EARLY DETECTION AND TREAT15 MENT SERVICES FOR PROSTATE CANCER.—

16 (1) IN GENERAL.—Chapter 17 of title 38, Unit17 ed States Code, is amended by inserting after sec18 tion 1724 a new section as follows:

19 ‘‘§ 1725. Early Detection and Treatment of Prostate

20 Cancer

21 ‘‘(a) The Secretary shall include in the medical serv22 ices made available to veterans under this chapter appro23 priate services for early detection, counseling, treatment,

24 and information on prostate cancer. Based on the best

25 available medical evidence, the Secretary shall develop and

26 implement an appropriate schedule for early detection of
12

S 691 IS

1 prostate cancer for those veterans confined to hospitals or

2 other institutions.

3 ‘‘(b) for the purposes of this section—

4 ‘‘(1) appropriate service for early detection of

5 prostate cancer means procedures provided to a man

6 for the purpose of early detection of prostate cancer,

7 including digital rectal examinations, prostate-spe8 cific antigen blood tests, and transactual

9 ultrasonography; and

10 ‘‘(2) appropriate prostate cancer treatment in11 cludes drugs approved by the Food and Drug Ad12 ministration for the treatment of prostate cancer.

13 ‘‘(c) The Secretary may carry out research and re14 search training in the diagnosis and treatment of prostate

15 cancer based upon the prostate cancer services provided

16 under this section and may develop guidelines outlining

17 effective treatment regimens for prostate cancer.’’.

18 (2) CLERICAL AMENDMENT.—The table of sec19 tions at the beginning of such chapter is amended

20 by inserting after the item relating to section 1724

21 the following new item:

‘‘1725. Early Detection and Treatment of Prostate Cancer.’’.
13

S 691 IS

1 SEC. 4. RESEARCH AND EDUCATION REGARDING PROS2 TATE CANCER; CERTAIN PROGRAMS OF PUB3 LIC HEALTH SERVICE.

4 (a) NATIONAL INSTITUTES OF HEALTH.—Section

5 417B(c) of the Public Health Service Act (42 U.S.C.

6 285a–8(c)) is amended in the first sentence by striking

7 ‘‘72,000,000’’ and all that follows and inserting the follow8 ing: ‘‘$86,000,000 for fiscal year 1996, $100,000,000 for

9 fiscal year 1997, $115,000,000 for fiscal year 1998, and

10 $130,000,000 for fiscal year 1999.’’.

11 (b) AGENCY FOR HEALTH CARE POLICY AND RE12 SEARCH.—Section 902 of the Public Health Service Act

13 (42 U.S.C. 299a) is amended by adding at the end the

14 following subsection:

15 ‘‘(f) ACTIVITIES REGARDING PROSTATE CANCER.—

16 The Administrator shall, with respect to prostate cancer—

17 ‘‘(1) conduct and support research on the out18 comes, effectiveness, and appropriateness of health

19 services and procedures; and

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

21 the development, periodic review, and updating of

22 clinically relevant guidelines, standards of quality,

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

Æ