I 

111TH CONGRESS 

1ST SESSION H. R. 1699 

To require that certain complex diagnostic laboratory tests performed by 

an independent laboratory after a hospital outpatient encounter or inpatient stay during which the specimen involved was collected shall be 

treated as services for which payment may be made directly to the 

laboratory under part B of title XVIII of the Social Security Act. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 25, 2009 

Mr. ALTMIRE (for himself, Mr. TIM MURPHY of Pennsylvania, and Ms. 

ESHOO) 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 require that certain complex diagnostic laboratory tests 

performed by an independent laboratory after a hospital 

outpatient encounter or inpatient stay during which the 

specimen involved was collected shall be treated as services for which payment may be made directly to the 

laboratory under part B of title XVIII of the Social 

Security Act. 

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 ‘‘Patient Access to Crit3 ical Lab Tests Act’’. 

4 SEC. 2. FINDINGS; SENSE OF CONGRESS. 

5 (a) FINDINGS.—The Congress finds as follows: 

6 (1) Timely access to laboratory testing is essen7 tial to ensure quality of care for patients. 

8 (2) Genetic and molecular laboratory testing 

9 are the new cornerstones of high quality, cost-effec10 tive preventive medicine. 

11 (3) The completion of the Human Genome 

12 Project in 2003 paved the way for a more sophisti13 cated understanding of disease causation, which has 

14 contributed to the advent of ‘‘personalized medi15 cine’’. 

16 (4) Personalized medicine is the application of 

17 genomic and molecular data to better target the de18 livery of health care, facilitate the discovery and clin19 ical testing of new products, and help determine a 

20 patient’s predisposition to a particular disease or 

21 condition. 

22 (5) Personalized medicine offers the promise of 

23 smarter, more effective, and safer care as physicians 

24 and patients become equipped with better informa25 tion to guide treatment decisions. 


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1 (6) Some of the most encouraging personalized 

2 medicine developments involve highly specialized lab3 oratory tests that, using biomarkers and vast stores 

4 of historical data, provide individualized information 

5 that enable physicians and patients to develop per6 sonalized treatment plans. 

7 (7) Several outdated Medicare regulations for 

8 laboratory billing are obstructing access to highly 

9 specialized laboratory tests and delaying patients’ di10 agnoses and treatments. These same rules are dis11 couraging investments in development of new tests. 

12 (8) Realizing the promise of personalized medi13 cine will require improved regulation that appro14 priately encourages development of and access to 

15 these specialized tests. 

16 (b) SENSE OF CONGRESS.—It is the sense of Con17 gress that— 

18 (1) where practical, Medicare regulations and 

19 policies should be written to promote development of 

20 and access to the highly specialized laboratory tests 

21 referred to in subsection (a)(6); and 

22 (2) the Medicare regulation described in section 

23 414.510 of title 42, Code of Federal Regulations, is 

24 one such regulation that should be revised to permit 

25 laboratories furnishing certain specialized tests to 


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1 bill for and be paid directly by Medicare for fur2 nishing such tests. 

3 SEC. 3. TREATMENT OF CERTAIN COMPLEX DIAGNOSTIC 

4 LABORATORY TESTS. 

5 (a) IN GENERAL.—Notwithstanding sections 

6 1862(a)(14) and 1866(a)(1)(H)(i) of the Social Security 

7 Act (42 U.S.C. 1395y(a)(14) and 1395cc(a)(1)(H)(i)), in 

8 the case that a laboratory performs a covered complex di9 agnostic laboratory test, with respect to a specimen col10 lected from an individual during a period in which the in11 dividual is a patient of a hospital, if the test is performed 

12 after such period the Secretary of Health and Human 

13 Services shall treat such test, for purposes of providing 

14 direct payment to the laboratory under section 1833(h) 

15 or 1848 of such Act (42 U.S.C. 1395l(h) or 1395w–4), 

16 as if such specimen had been collected directly by the lab17 oratory. 

18 (b) COVERED COMPLEX DIAGNOSTIC LABORATORY

19 TEST DEFINED.—For purposes of this section, the term 

20 ‘‘covered complex diagnostic laboratory test’’ means an 

21 analysis— 

22 (1) of DNA, RNA, chromosomes, proteins, or 

23 metabolites that detects genotypes, mutations, chro24 mosomal changes, biochemical changes, cell re25 sponse, or gene expression or is a cancer chemoVerDate Nov 24 2008 02:56 Mar 26, 2009 Jkt 079200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H1699.IH H1699

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1 therapy sensitivity assay, but does not include meth2 ods principally comprising immunohistochemistry, 

3 flow cytometry, enzyme assay or immunoassay; 

4 (2) that is described in section 1861(s)(3) of 

5 the Social Security Act (42 U.S.C. 1395x(s)(3)); 

6 (3) that is developed and performed by a lab7 oratory which is independent of the hospital in which 

8 the specimen involved was collected and not under 

9 any arrangements (as defined in section 1861(w)(1) 

10 of such Act (42 U.S.C. 1395x(w)(1)); and 

11 (4) that is not furnished by the hospital where 

12 the specimen was collected to a patient of such hos13 pital, directly or under arrangements (as defined in 

14 section 1861(w)(1) of such Act (42 U.S.C. 

15 1395x(w)(1)) made by such hospital. 

16 SEC. 4. EFFECTIVE DATE. 

17 The provisions of section 3 shall apply to tests fur18 nished on or after the date of the enactment of this Act. 

Æ 


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