Diabetic Retinopathy Prevention Act of 2003, HR-3458

HR 3458 IH

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

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

SECTION 1. SHORT TITLE.

This Act may be cited as the `Diabetic Retinopathy Prevention Act of 2003'.

SEC. 2. FINDINGS.

The Congress finds as follows:

(1) Type 2 diabetes affects 17,000,000 Americans, with over 1,000,000 new cases diagnosed each year, and costs the Nation an estimated $138,000,000,000 per year.

(2) Diabetic retinopathy is the most common complication resulting from diabetes, and causes degradation in visual acuity and eventual blindness. Diabetic retinopathy is the leading cause of blindness in people aged 20 to 74, and up to 24,000 diabetics become legally blind each year.

(3) Most individuals with diabetes will ultimately develop diabetic retinopathy, and the risk of diabetic retinopathy increases with the duration of diabetes. Onset of type 2 diabetes is today occurring at younger ages, which will increase the prevalence of diabetic retinopathy in the future.

(4) Clinical trials have demonstrated that early detection and treatment of diabetic retinopathy can reduce vision loss by 90 percent, and remote assessment of diabetic retinopathy has the potential to reach large numbers of diabetic patients who live in rural, remote or underserved areas and who lack geographical or financial access to regular, in-office eye examinations by eye specialists.

SEC. 3. MEDICARE COVERAGE OF REMOTE ASSESSMENT OF DIABETIC RETINOPATHY.

(a) COVERAGE- Section 1861 of the Social Security Act (42 U.S.C. 1395x) is amended--

(1) in paragraph (s)(1)--

(A) in subparagraph (U), by striking `and' at the end;

(B) in subparagraph (V)(iii), by adding `and' at the end; and

`(W) remote assessment of diabetic retinopathy (as defined in subsection (ww));'; and

(2) by adding at the end the following new subsection:

`Remote Assessment of Diabetic Retinopathy

`(ww) The term `remote assessment of diabetic retinopathy' means a diagnostic examination of the retina for the purpose of early detection of diabetic retinopathy that--

`(1) is provided not more frequently than on an annual basis to an individual who has been diagnosed with diabetes;

`(2) meets technical standards set forth by the Secretary (which shall be determined in consultation with industry and practitioner groups with expertise in ophthalmic photography, telemedicine, or related fields); and

`(3) is furnished via a telecommunications system by a physician (as defined in subsection (r)), a practitioner (described in section 1842(b)(18)(C) of this title), or a non-physician technician deemed to be qualified by the Secretary under the regulations promulgated pursuant to this Act, to an eligible patient enrolled under this part, notwithstanding that the individual physician or practitioner providing the service is not at the same location as the beneficiary.'.

(b) PAYMENT NOTWITHSTANDING LIMITATION ON STORE AND FORWARD TECHNOLOGY- Notwithstanding any limitations to the contrary that are set forth in section 1834(m)(1) of the Social Security Act (42 U.S.C. 1395m(m)(1)), the amendments made by subsection (a) shall be applicable to remote assessments of diabetic retinopathy that are furnished through the use of store-and-forward technologies that provide for the asynchronous transmission of health care information in single or multimedia formats.

(c) INTERIM PAYMENT PENDING PUBLICATION OF FINAL RULE- For the period beginning 30 days after the date of the enactment of this Act and ending on the date the Secretary of Health and Human Services publishes a final regulation to carry out section 1861(s)(1)(W) of the Social Security Act, as added by subsection (a), the Secretary shall provide for payment of retinopathy assessments furnished under such section during such period, and assign such temporary HCPCS code as is necessary to provide for such payment.

(d) STUDY ON REIMBURSEMENT FOR REMOTE ASSESSMENTS OF DIABETIC RETINOPATHY- (1) Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall conduct a study on the costs incurred by health care providers to provide remote assessment of diabetic retinopathy services, including an analysis of--

(A) per-patient cost, and

(B) start-up and administrative costs.

(2) Not later than 2 years after the date of the enactment of this Act, the Secretary shall submit a report to Congress on the study conducted under paragraph (1) and shall include recommendations as respect to--

(A) the adequacy of reimbursements for remote assessment of diabetic retinopathy under the medicare program; and

(B) whether the study under paragraph (1) should be repeated, and if so, how frequently.

(e) EFFECTIVE DATE- The amendments made by subsection (a) shall apply to assessments performed on or after the date that is 30 days after the date of the enactment of this Act.

SEC. 4 MEDICAID COVERAGE OF REMOTE ASSESSMENT OF DIABETIC RETINOPATHY.

(a) REQUIREMENT- Section 1905(a)(13) of the Social Security Act (42 U.S.C. 1396d(a)(13)) is amended by inserting `remote assessment of diabetic retinopathy (as defined in section 1861(s)(1)(ww)),' after `including'.

(b) EFFECTIVE DATE- The amendments made by subsection (a) shall apply to assessments performed on or after the date of the enactment of this Act.

(c) STATE COMPLIANCE- In the case of a State plan for medical assistance under title XIX of the Social Security Act which the Secretary of Health and Human Services determines requires State legislation (other than legislation authorizing or appropriating funds) in order for the

plan to meet the additional requirement imposed by the amendments made by subsection (a), the State plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet this additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of such session shall be deemed to be a separate regular session of the State legislature.

SEC. 5. MOBILE DIABETIC RETINOPATHY SCREENING PILOT PROGRAM.

Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) is amended--

(1) by moving section 317R so that it follows section 317Q; and

(2) by inserting after section 317R (as so moved) the following:

`SEC. 317S. MOBILE DIABETIC RETINOPATHY SCREENING PILOT PROGRAM.

`(a) IN GENERAL-

`(1) ESTABLISHMENT- The Secretary shall establish a grant program, to be known as the `Mobile Diabetic Retinopathy Screening Pilot Program', to make grants to 5 eligible entities for the purpose of establishing mobile diabetic retinopathy screening programs.

`(2) USE OF FUNDS- The Secretary may not make a grant to an eligible entity under this section unless the entity agrees to use the grant to carry out a project consisting of the design, demonstration, and implementation of a mobile diabetic retinopathy screening program.

`(3) MAXIMUM AMOUNT- The Secretary may not make any grant under this section in an amount that is greater than $1,000,000 for any year.

`(4) SOLICITATION OF APPLICATIONS- Not later than 90 days after the date on which amounts are first made available to carry out this section, the Secretary shall publish a notice of solicitation for applications for grants under this section that specifies the information to be included in each application.

`(5) APPLICATIONS- To seek a grant under this section, an eligible entity shall submit an application to the Secretary at such time, in such form, and containing such information as the Secretary may require.

`(6) PRIORITY- In making grants under this section, the Secretary shall give priority to any applicant that--

`(A) has experience in evaluating diabetic retinopathy using telecommunications equipment, including store and forward technologies; and

`(B) proposes to serve rural, impoverished, minority, and remote populations.

`(7) CONGRESSIONAL NOTIFICATION- The Secretary may not make a grant under this section unless, not less than 3 days before making the grant, the Secretary provides notification of the grant to the appropriate committees of the Congress.

`(b) EVALUATION AND REPORT-

`(1) EVALUATION- Not later than 3 years after making the first grant under this section, the Secretary shall convene an advisory committee for the purposes of conducting an evaluation of the Mobile Diabetic Retinopathy Screening Pilot Program. In conducting the evaluation, the advisory committee shall determine--

`(A) whether the Program has been effective in increasing early detection of diabetic retinopathy, whether preventative measures taken upon such detection have been effective in decreasing the prevalence and severity of diabetic retinopathy, and whether these findings warrant continued or expanded support of the Program; and

`(B) whether the program may serve as a useful model for similar screening programs to detect complications associated with diabetes, high blood pressure, high cholesterol, and other chronic conditions.

`(2) REPORT- Not later than 42 months after making the first grant under this section, the Secretary shall submit a report to the appropriate committees of the Congress containing the results of the advisory committee's evaluation.

`(c) DEFINITIONS- In this section:

`(1) ADVISORY COMMITTEE- The term `advisory committee' means the advisory committee convened under subsection (b).

`(2) ELIGIBLE ENTITY- The term `eligible entity' means--

`(A) a hospital (as defined in section 1861(e) of the Social Security Act (42 U.S.C. 1395x(e))); or

`(B) a State, an institution of higher education, a local government, a tribal government, a nonprofit health organization, or a community health center receiving assistance under section 330.

`(3) MOBILE DIABETIC RETINOPATHY SCREENING PROGRAM- The term `mobile diabetic retinopathy screening program' means any program--

`(A) that offers remote assessment of diabetic retinopathy as described in Section 1861(s)(1) of the Social Security Act (42 U.S.C. 1395x);

`(B) whose patients primarily reside in rural, underserved, and remote areas; and

`(C) that is mobile (as determined by the Secretary).

`(4) PROGRAM- The term `Program' means the Mobile Diabetic Retinopathy Screening Pilot Program established under this section.

`(d) AUTHORIZATION OF APPROPRIATIONS-

`(1) IN GENERAL- There is authorized to be appropriated to carry out this section (except for subsection (b)) $5,000,000 for each of fiscal years 2005 through 2009.

`(2) EVALUATION AND REPORT- There are authorized to be appropriated to carry out subsection (b) such sums as may be necessary.'.

END