I 

108TH CONGRESS 

1ST SESSION H. R. 3458

To amend titles XVIII and XIX of the Social Security Act to provide for 

coverage under the Medicare and Medicaid Programs of certain screening 

procedures for diabetic retinopathy, and to amend the Public Health 

Service Act to establish pilot programs to foster such screening, and 

for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

NOVEMBER 6, 2003

Mr. COOPER introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on 

Ways and Means, 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 titles XVIII and XIX of the Social Security Act 

to provide for coverage under the Medicare and Medicaid 

Programs of certain screening procedures for diabetic 

retinopathy, and to amend the Public Health Service 

Act to establish pilot programs to foster such screening, 

and for other purposes.

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 ‘‘Diabetic Retinopathy 

3 Prevention Act of 2003’’. 

4 SEC. 2. FINDINGS. 

5 The Congress finds as follows: 

6 (1) Type 2 diabetes affects 17,000,000 Ameri7 cans, with over 1,000,000 new cases diagnosed each 

8 year, and costs the Nation an estimated 

9 $138,000,000,000 per year. 

10 (2) Diabetic retinopathy is the most common 

11 complication resulting from diabetes, and causes 

12 degradation in visual acuity and eventual blindness. 

13 Diabetic retinopathy is the leading cause of blind14 ness in people aged 20 to 74, and up to 24,000 dia15 betics become legally blind each year. 

16 (3) Most individuals with diabetes will ulti17 mately develop diabetic retinopathy, and the risk of 

18 diabetic retinopathy increases with the duration of 

19 diabetes. Onset of type 2 diabetes is today occurring 

20 at younger ages, which will increase the prevalence 

21 of diabetic retinopathy in the future. 

22 (4) Clinical trials have demonstrated that early 

23 detection and treatment of diabetic retinopathy can 

24 reduce vision loss by 90 percent, and remote assess25 ment of diabetic retinopathy has the potential to 

26 reach large numbers of diabetic patients who live in 
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1 rural, remote or underserved areas and who lack 

2 geographical or financial access to regular, in-office 

3 eye examinations by eye specialists. 

4 SEC. 3. MEDICARE COVERAGE OF REMOTE ASSESSMENT OF 

5 DIABETIC RETINOPATHY. 

6 (a) COVERAGE.—Section 1861 of the Social Security 

7 Act (42 U.S.C. 1395x) is amended—

8 (1) in paragraph (s)(1)—

9 (A) in subparagraph (U), by striking 

10 ‘‘and’’ at the end; 

11 (B) in subparagraph (V)(iii), by adding 

12 ‘‘and’’ at the end; and 

13 (C) by inserting after subparagraph (V) 

14 the following new subparagraph: 

15 ‘‘(W) remote assessment of diabetic retinopathy 

16 (as defined in subsection (ww));’’; and 

17 (2) by adding at the end the following new sub18 section: 

19 ‘‘Remote Assessment of Diabetic Retinopathy 

20 ‘‘(ww) The term ‘remote assessment of diabetic ret21 inopathy’ means a diagnostic examination of the retina for 

22 the purpose of early detection of diabetic retinopathy 

23 that—
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1 ‘‘(1) is provided not more frequently than on an 

2 annual basis to an individual who has been diag3 nosed with diabetes; 

4 ‘‘(2) meets technical standards set forth by the 

5 Secretary (which shall be determined in consultation 

6 with industry and practitioner groups with expertise 

7 in ophthalmic photography, telemedicine, or related 

8 fields); and 

9 ‘‘(3) is furnished via a telecommunications sys10 tem by a physician (as defined in subsection (r)), a 

11 practitioner (described in section 1842(b)(18)(C) of 

12 this title), or a non-physician technician deemed to 

13 be qualified by the Secretary under the regulations 

14 promulgated pursuant to this Act, to an eligible pa15 tient enrolled under this part, notwithstanding that 

16 the individual physician or practitioner providing the 

17 service is not at the same location as the bene18 ficiary.’’. 

19 (b) PAYMENT NOTWITHSTANDING LIMITATION ON

20 STORE AND FORWARD TECHNOLOGY.—Notwithstanding 

21 any limitations to the contrary that are set forth in section 

22 1834(m)(1) of the Social Security Act (42 U.S.C. 

23 1395m(m)(1)), the amendments made by subsection (a) 

24 shall be applicable to remote assessments of diabetic ret25 inopathy that are furnished through the use of store-and-
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1 forward technologies that provide for the asynchronous 

2 transmission of health care information in single or multi3 media formats. 

4 (c) INTERIM PAYMENT PENDING PUBLICATION OF

5 FINAL RULE.—For the period beginning 30 days after the 

6 date of the enactment of this Act and ending on the date 

7 the Secretary of Health and Human Services publishes a 

8 final regulation to carry out section 1861(s)(1)(W) of the 

9 Social Security Act, as added by subsection (a), the Sec10 retary shall provide for payment of retinopathy assess11 ments furnished under such section during such period, 

12 and assign such temporary HCPCS code as is necessary 

13 to provide for such payment. 

14 (d) STUDY ON REIMBURSEMENT FOR REMOTE AS15 SESSMENTS OF DIABETIC RETINOPATHY.—(1) Not later 

16 than 1 year after the date of the enactment of this Act, 

17 the Secretary of Health and Human Services shall conduct 

18 a study on the costs incurred by health care providers to 

19 provide remote assessment of diabetic retinopathy serv20 ices, including an analysis of—

21 (A) per-patient cost, and 

22 (B) start-up and administrative costs. 

23 (2) Not later than 2 years after the date of the enact24 ment of this Act, the Secretary shall submit a report to 
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1 Congress on the study conducted under paragraph (1) and 

2 shall include recommendations as respect to—

3 (A) the adequacy of reimbursements for remote 

4 assessment of diabetic retinopathy under the medi5 care program; and 

6 (B) whether the study under paragraph (1) 

7 should be repeated, and if so, how frequently. 

8 (e) EFFECTIVE DATE.—The amendments made by 

9 subsection (a) shall apply to assessments performed on or 

10 after the date that is 30 days after the date of the enact11 ment of this Act. 

12 SEC. 4 MEDICAID COVERAGE OF REMOTE ASSESSMENT OF 

13 DIABETIC RETINOPATHY. 

14 (a) REQUIREMENT.—Section 1905(a)(13) of the So15 cial Security Act (42 U.S.C. 1396d(a)(13)) is amended by 

16 inserting ‘‘remote assessment of diabetic retinopathy (as 

17 defined in section 1861(s)(1)(ww)),’’ after ‘‘including’’. 

18 (b) EFFECTIVE DATE.—The amendments made by 

19 subsection (a) shall apply to assessments performed on or 

20 after the date of the enactment of this Act. 

21 (c) STATE COMPLIANCE.—In the case of a State plan 

22 for medical assistance under title XIX of the Social Secu23 rity Act which the Secretary of Health and Human Serv24 ices determines requires State legislation (other than legis25 lation authorizing or appropriating funds) in order for the
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1 plan to meet the additional requirement imposed by the 

2 amendments made by subsection (a), the State plan shall 

3 not be regarded as failing to comply with the requirements 

4 of such title solely on the basis of its failure to meet this 

5 additional requirement before the first day of the first cal6 endar quarter beginning after the close of the first regular 

7 session of the State legislature that begins after the date 

8 of the enactment of this Act. For purposes of the previous 

9 sentence, in the case of a State that has a 2-year legisla10 tive session, each year of such session shall be deemed to 

11 be a separate regular session of the State legislature. 

12 SEC. 5. MOBILE DIABETIC RETINOPATHY SCREENING 

13 PILOT PROGRAM. 

14 Title III of the Public Health Service Act (42 U.S.C. 

15 241 et seq.) is amended—

16 (1) by moving section 317R so that it follows 

17 section 317Q; and 

18 (2) by inserting after section 317R (as so 

19 moved) the following: 

20 ‘‘SEC. 317S. MOBILE DIABETIC RETINOPATHY SCREENING 

21 PILOT PROGRAM. 

22 ‘‘(a) IN GENERAL.—

23 ‘‘(1) ESTABLISHMENT.—The Secretary shall es24 tablish a grant program, to be known as the ‘‘Mobile 

25 Diabetic Retinopathy Screening Pilot Program’’, to 
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1 make grants to 5 eligible entities for the purpose of 

2 establishing mobile diabetic retinopathy screening 

3 programs. 

4 ‘‘(2) USE OF FUNDS.—The Secretary may not 

5 make a grant to an eligible entity under this section 

6 unless the entity agrees to use the grant to carry out 

7 a project consisting of the design, demonstration, 

8 and implementation of a mobile diabetic retinopathy 

9 screening program. 

10 ‘‘(3) MAXIMUM AMOUNT.—The Secretary may 

11 not make any grant under this section in an amount 

12 that is greater than $1,000,000 for any year. 

13 ‘‘(4) SOLICITATION OF APPLICATIONS.—Not 

14 later than 90 days after the date on which amounts 

15 are first made available to carry out this section, the 

16 Secretary shall publish a notice of solicitation for ap17 plications for grants under this section that specifies 

18 the information to be included in each application. 

19 ‘‘(5) APPLICATIONS.—To seek a grant under 

20 this section, an eligible entity shall submit an appli21 cation to the Secretary at such time, in such form, 

22 and containing such information as the Secretary 

23 may require. 
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1 ‘‘(6) PRIORITY.—In making grants under this 

2 section, the Secretary shall give priority to any ap3 plicant that—

4 ‘‘(A) has experience in evaluating diabetic 

5 retinopathy using telecommunications equip6 ment, including store and forward technologies; 

7 and 

8 ‘‘(B) proposes to serve rural, impoverished, 

9 minority, and remote populations. 

10 ‘‘(7) CONGRESSIONAL NOTIFICATION.—The 

11 Secretary may not make a grant under this section 

12 unless, not less than 3 days before making the 

13 grant, the Secretary provides notification of the 

14 grant to the appropriate committees of the Congress. 

15 ‘‘(b) EVALUATION AND REPORT.—

16 ‘‘(1) EVALUATION.—Not later than 3 years 

17 after making the first grant under this section, the 

18 Secretary shall convene an advisory committee for 

19 the purposes of conducting an evaluation of the Mo20 bile Diabetic Retinopathy Screening Pilot Program. 

21 In conducting the evaluation, the advisory committee 

22 shall determine—

23 ‘‘(A) whether the Program has been effec24 tive in increasing early detection of diabetic ret25 inopathy, whether preventative measures taken 
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1 upon such detection have been effective in de2 creasing the prevalence and severity of diabetic 

3 retinopathy, and whether these findings war4 rant continued or expanded support of the Pro5 gram; and 

6 ‘‘(B) whether the program may serve as a 

7 useful model for similar screening programs to 

8 detect complications associated with diabetes, 

9 high blood pressure, high cholesterol, and other 

10 chronic conditions. 

11 ‘‘(2) REPORT.—Not later than 42 months after 

12 making the first grant under this section, the Sec13 retary shall submit a report to the appropriate com14 mittees of the Congress containing the results of the 

15 advisory committee’s evaluation. 

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

17 ‘‘(1) ADVISORY COMMITTEE.—The term ‘advi18 sory committee’ means the advisory committee con19 vened under subsection (b). 

20 ‘‘(2) ELIGIBLE ENTITY.—The term ‘eligible en21 tity’ means—

22 ‘‘(A) a hospital (as defined in section 

23 1861(e) of the Social Security Act (42 U.S.C. 

24 1395x(e))); or 
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1 ‘‘(B) a State, an institution of higher edu2 cation, a local government, a tribal government, 

3 a nonprofit health organization, or a community 

4 health center receiving assistance under section 

5 330. 

6 ‘‘(3) MOBILE DIABETIC RETINOPATHY SCREEN7 ING PROGRAM.—The term ‘mobile diabetic retinop8 athy screening program’ means any program—

9 ‘‘(A) that offers remote assessment of dia10 betic retinopathy as described in Section 

11 1861(s)(1) of the Social Security Act (42 

12 U.S.C. 1395x); 

13 ‘‘(B) whose patients primarily reside in 

14 rural, underserved, and remote areas; and 

15 ‘‘(C) that is mobile (as determined by the 

16 Secretary). 

17 ‘‘(4) PROGRAM.—The term ‘Program’ means 

18 the Mobile Diabetic Retinopathy Screening Pilot 

19 Program established under this section. 

20 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—

21 ‘‘(1) IN GENERAL.—There is authorized to be 

22 appropriated to carry out this section (except for 

23 subsection (b)) $5,000,000 for each of fiscal years 

24 2005 through 2009. 
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1 ‘‘(2) EVALUATION AND REPORT.—There are 

2 authorized to be appropriated to carry out sub3 section (b) such sums as may be necessary.’’.

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