II 

111TH CONGRESS 

1ST SESSION S. 1220 

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 SENATE OF THE UNITED STATES 

JUNE 9, 2009 

Mr. SPECTER (for himself and Mr. WYDEN) introduced the following bill; 

which was read twice and referred to the Committee on Finance 

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, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Patient Access to Crit5 ical Lab Tests Act’’. 


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1 SEC. 2. FINDINGS; SENSE OF CONGRESS. 

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

3 (1) Timely access to laboratory testing is essen4 tial to ensure quality of care for patients. 

5 (2) Genetic and molecular laboratory testing 

6 are the new cornerstones of high-quality, cost-effec7 tive preventive medicine. 

8 (3) The completion of the Human Genome 

9 Project in 2003 paved the way for a more sophisti10 cated understanding of disease causation, which has 

11 contributed to the advent of ‘‘personalized medi12 cine’’. 

13 (4) Personalized medicine is the application of 

14 genomic and molecular data to better target the de15 livery of health care, facilitate the discovery and clin16 ical testing of new products, and help determine a 

17 patient’s predisposition to a particular disease or 

18 condition. 

19 (5) Personalized medicine offers the promise of 

20 smarter, more effective, and safer care as physicians 

21 and patients become equipped with better informa22 tion to guide treatment decisions. 

23 (6) Some of the most encouraging personalized 

24 medicine developments involve highly specialized lab25 oratory tests that, using biomarkers and vast stores 

26 of historical data, provide individualized information 


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1 that enable physicians and patients to develop per2 sonalized treatment plans. 

3 (7) Several outdated Medicare regulations for 

4 laboratory billing are obstructing access to highly 

5 specialized laboratory tests and delaying patients’ di6 agnoses and treatments. These same rules are dis7 couraging investments in development of new tests. 

8 (8) Realizing the promise of personalized medi9 cine will require improved regulation that appro10 priately encourages development of and access to 

11 these specialized tests. 

12 (b) SENSE OF CONGRESS.—It is the sense of Con13 gress that— 

14 (1) where practical, Medicare regulations and 

15 policies should be written to promote development of 

16 and access to the highly specialized laboratory tests 

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

18 (2) the Medicare regulation described in section 

19 414.510 of title 42, Code of Federal Regulations, is 

20 one such regulation that should be revised to permit 

21 laboratories furnishing certain specialized tests to 

22 bill for and be paid directly by Medicare for fur23 nishing such tests. 


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1 SEC. 3. TREATMENT OF CERTAIN COMPLEX DIAGNOSTIC 

2 LABORATORY TESTS. 

3 (a) IN GENERAL.—Notwithstanding sections 

4 1862(a)(14) and 1866(a)(1)(H)(i) of the Social Security 

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

6 the case that a laboratory performs a covered complex di7 agnostic laboratory test, with respect to a specimen col8 lected from an individual during a period in which the in9 dividual is a patient of a hospital, if the test is performed 

10 after such period the Secretary of Health and Human 

11 Services shall treat such test, for purposes of providing 

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

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

14 as if such specimen had been collected directly by the lab15 oratory. 

16 (b) COVERED COMPLEX DIAGNOSTIC LABORATORY

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

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

19 analysis— 

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

21 metabolites that detects, identifies, or quantitates 

22 genotypes, mutations, chromosomal changes, bio23 chemical changes, cell response, protein expression, 

24 or gene expression or similar method or is a cancer 

25 chemotherapy sensitivity assay or similar method, 


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1 but does not include methods principally comprising 

2 routine chemistry or routine immunology; 

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

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

5 (3) that is developed and performed by a lab6 oratory which is independent of the hospital in which 

7 the specimen involved was collected and not under 

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

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

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

11 the specimen was collected to a patient of such hos12 pital, directly or under arrangements (as defined in 

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

14 1395x(w)(1))) made by such hospital. 

15 SEC. 4. EFFECTIVE DATE. 

16 The provisions of section 3 shall apply to tests fur17 nished on or after the date of the enactment of this Act. 

Æ 


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