I

103D CONGRESS

2D SESSION H. R. 4809

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 HOUSE OF REPRESENTATIVES

JULY 21, 1994

Mr. MCDERMOTT (for himself, Mr. APPLEGATE, Mr. FIELDS of Texas, Mr.

GUTIERREZ, Mr. HORN, Mr. HUGHES, Mr. KING, Mrs. MINK, Mrs.

MORELLA, Ms. PELOSI, Mr. ROMERO-BARCELO ́, Mr. SWIFT, and Mr.

WASHINGTON) introduced the following bill; which was referred jointly to

the Committees on Energy and Commerce, Ways and Means, and Veterans’ Affairs

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.
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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 1994’’.

6 SEC. 2. MEDICARE COVERAGE OF PROSTATE CANCER

7 SCREENING AND CERTAIN DRUG TREAT8 MENTS.

9 (a) COVERAGE OF SCREENING 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:

21 ‘‘(R) prostate cancer screening services (as de22 fined in subsection (ll));’’.

23 (2) SERVICES DESCRIBED.—Section 1861 of

24 such Act (42 U.S.C. 1395x) is amended—
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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 ‘‘Prostate Cancer Screening Services

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

9 means the following procedures provided to a man for the

10 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 PROSTATE CANCER SCREENING SERVICES.—

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

24 provision of this part, with respect to expenses in-
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1 curred for prostate cancer screening services (as de2 fined 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 a prostate cancer

10 screening service consisting of a prostate11 specific antigen blood test, the fee schedule

12 amount established for the service under

13 section 1833(h) (relating to payments for

14 clinical diagnostic laboratory tests); or

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

16 cancer screening service, the amount pro17 vided under the fee schedule established by

18 the Secretary under paragraph (3) (subject

19 to the deductible established under section

20 1833(b)).

21 ‘‘(2) FREQUENCY COVERED.—

22 ‘‘(A) IN GENERAL.—Subject to subpara23 graph (B) and to revision by the Secretary

24 under subparagraph (C), no payment may be

25 made under this part for a prostate cancer
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1 screening service provided to an individual for

2 the purpose of early detection of prostate can3 cer—

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 screening service.

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

11 for a prostate cancer screening service provided

12 to an individual more frequently than the limit

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

14 individual is at a high risk of developing pros15 tate cancer (as determined pursuant to factors

16 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 prostate cancer screening services based on

23 age and such other factors as the Sec24 retary believes to be pertinent.
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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 prostate cancer screening serv14 ices under this part (other than prostate-spe15 cific antigen blood tests), effective for services

16 furnished after the expiration of the 90-day pe17 riod beginning on the date the Secretary estab18 lishes 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
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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 pros6 tate cancer screening service provided to an in7 dividual for the purpose of early detection of

8 prostate cancer for which payment may be

9 made under this part, if a nonparticipating phy10 sician or supplier provides the procedure to an

11 individual enrolled under this part, the physi12 cian or supplier may not charge the individual

13 more than the limiting charge (as defined in

14 section 1848(g)(2)).

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

16 supplier knowing and willfully imposes a charge

17 in violation of subparagraph (A), the Secretary

18 may apply sanctions against such physician or

19 supplier in accordance with section

20 1842(j)(2).’’.

21 (4) CONFORMING AMENDMENTS.—(A) Para22 graphs (1)(D) and (2)(D) of section 1833(a) of such

23 Act (42 U.S.C. 1395l(a)) are each amended by strik24 ing ‘‘subsection (h)(1),’’ and inserting ‘‘subsection

25 (h)(1) or section 1834(d)(1)(B)(i),’’.
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1 (B) Section 1833(a)(1) of such Act (42 U.S.C.

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

3 OBRA–1993, is amended—

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

5 ‘‘(P)’’; and

6 (ii) by striking the semicolon at the end

7 and inserting the following: ‘‘, and (Q) with re8 spect to prostate cancer screening services (as

9 defined in section 1861(ll)) (other than pros10 tate-specific antigen tests), the amounts paid

11 shall be the amounts described in section

12 1834(d)(1);’’.

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

14 1395l(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 prostate cancer screening

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

23 prostate-specific antigen tests), the amounts de24 scribed in section 1834(d)(1).’’.
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1 (D) Section 1833(h)(1)(A) of such Act (42

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

3 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 prostate cancer screening

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

20 the purpose of early detection of prostate cancer,

21 which are performed more frequently than is covered

22 under section 1834(d)(2);’’; and

23 (ii) in paragraph (7), by striking ‘‘para24 graph (1)(B) or under paragraph (1)(F)’’ and
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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 this section shall apply to services provided on or after

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

20 Secretary 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.
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1 SEC. 3. COVERAGE OF PROSTATE CANCER SCREENING AND

2 TREATMENT SERVICES FOR VETERANS.

3 (a) PROSTATE CANCER SCREENING AND DIAGNOSIS

4 DEFINED AS PREVENTIVE HEALTH SERVICE.—Section

5 1701(9) of title 38, United States Code is amended—

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

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

8 (2) by inserting after subparagraph (I) the fol9 lowing new subparagraph (J):

10 ‘‘(J) screening and diagnostic tests approved

11 for prostate cancer;’’.

12 (b) COVERAGE OF PROSTATE CANCER SCREENING

13 AND TREATMENT.—

14 (1) IN GENERAL.—Chapter 17 of title 38, Unit15 ed States Code, is amended by inserting after sec16 tion 1724 a new section as follows:

17 ‘‘§ 1725. Prostate cancer screening and treatment

18 ‘‘(a) The Secretary shall include in the medical serv19 ices made available to veterans under this chapter appro20 priate prostate cancer screening, counseling, treatment,

21 and information. Based on the best available medical evi22 dence, the Secretary shall develop and implement an ap23 propriate prostate cancer screening schedule for those vet24 erans confined to hospitals or other institutions.

25 ‘‘(b) For the purposes of this section—
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1 ‘‘(1) appropriate prostate cancer screening

2 means procedures provided to a man for the purpose

3 of early detection of prostate cancer, including digi4 tal rectal examinations, prostate-specific antigen

5 blood tests, and transrectal ultrasonography; and

6 ‘‘(2) appropriate prostate cancer treatment in7 cludes drugs approved by the Food and Drug Ad8 ministration for the treatment of prostate cancer.

9 ‘‘(c) The Secretary may carry out research and re10 search training in the diagnosis and treatment of prostate

11 cancer based upon the prostate cancer services provided

12 under this section and may develop guidelines outlining

13 effective treatment regimens for prostate cancer.’’.

14 (2) CLERICAL AMENDMENT.—The table of sec15 tions at the beginning of such chapter is amended

16 by inserting after the item relating to section 1724

17 the following new item:

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

18 SEC. 4. RESEARCH AND EDUCATION REGARDING PROS19 TATE CANCER; CERTAIN PROGRAMS OF PUB20 LIC HEALTH SERVICE.

21 (a) NATIONAL INSTITUTES OF HEALTH.—Section

22 417B(c) of the Public Health Service Act (42 U.S.C.

23 286a–8(c)) is amended in the first sentence by striking

24 ‘‘$72,000,000’’ and all that follows and inserting the fol25 lowing: ‘‘$72,000,000 for fiscal year 1994, $86,000,000
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1 for fiscal year 1995, $100,000,000 for fiscal year 1996,

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

3 years 1997 and 1998.’’.

4 (b) AGENCY FOR HEALTH CARE POLICY AND RE5 SEARCH.—Section 902 of the Public Health Service Act

6 (42 U.S.C. 299a) is amended by adding at the end the

7 following subsection:

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

9 The Administrator shall, with respect to prostate cancer—

10 ‘‘(1) conduct and support research on the out11 comes, effectiveness, and appropriateness of health

12 services and procedures; and

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

14 the development, periodic review, and updating of

15 clinically relevant guidelines, standards of quality,

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

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