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 inpa-
tient 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 Com-
mittee 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 serv-
ices for which payment may be made directly to the 
laboratory under part B of title XVIII of the Social 
Security Act. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
VerDate Nov 24 2008 
02:56 Mar 26, 2009
Jkt 079200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H1699.IH
H1699
smartinez on PROD1PC64 with BILLS
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Patient Access to Crit-
ical Lab Tests Act’’. 
SEC. 2. FINDINGS; SENSE OF CONGRESS. 
(a) FINDINGS.—The Congress finds as follows: 
(1) Timely access to laboratory testing is essen-
tial to ensure quality of care for patients. 
(2) Genetic and molecular laboratory testing 
are the new cornerstones of high quality, cost-effec-
tive preventive medicine. 
(3) The completion of the Human Genome 
Project in 2003 paved the way for a more sophisti-
cated understanding of disease causation, which has 
contributed to the advent of ‘‘personalized medi-
cine’’. 
(4) Personalized medicine is the application of 
genomic and molecular data to better target the de-
livery of health care, facilitate the discovery and clin-
ical testing of new products, and help determine a 
patient’s predisposition to a particular disease or 
condition. 
(5) Personalized medicine offers the promise of 
smarter, more effective, and safer care as physicians 
and patients become equipped with better informa-
tion to guide treatment decisions. 
VerDate Nov 24 2008 
02:56 Mar 26, 2009
Jkt 079200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H1699.IH
H1699
smartinez on PROD1PC64 with BILLS
(6) Some of the most encouraging personalized 
medicine developments involve highly specialized lab-
oratory tests that, using biomarkers and vast stores 
of historical data, provide individualized information 
that enable physicians and patients to develop per-
sonalized treatment plans. 
(7) Several outdated Medicare regulations for 
laboratory billing are obstructing access to highly 
specialized laboratory tests and delaying patients’ di-
agnoses and treatments. These same rules are dis-
couraging investments in development of new tests. 
(8) Realizing the promise of personalized medi-
cine will require improved regulation that appro-
priately encourages development of and access to 
these specialized tests. 
(b) SENSE OF CONGRESS.—It is the sense of Con-
gress that— 
(1) where practical, Medicare regulations and 
policies should be written to promote development of 
and access to the highly specialized laboratory tests 
referred to in subsection (a)(6); and 
(2) the Medicare regulation described in section 
414.510 of title 42, Code of Federal Regulations, is 
one such regulation that should be revised to permit 
laboratories furnishing certain specialized tests to 
VerDate Nov 24 2008 
02:56 Mar 26, 2009
Jkt 079200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H1699.IH
H1699
smartinez on PROD1PC64 with BILLS
bill for and be paid directly by Medicare for fur-
nishing such tests. 
SEC. 3. TREATMENT OF CERTAIN COMPLEX DIAGNOSTIC 
LABORATORY TESTS. 
(a) 
IN
GENERAL.—Notwithstanding 
sections 
1862(a)(14) and 1866(a)(1)(H)(i) of the Social Security 
Act (42 U.S.C. 1395y(a)(14) and 1395cc(a)(1)(H)(i)), in 
the case that a laboratory performs a covered complex di-
agnostic laboratory test, with respect to a specimen col-
lected from an individual during a period in which the in-
dividual is a patient of a hospital, if the test is performed 
after such period the Secretary of Health and Human 
Services shall treat such test, for purposes of providing 
direct payment to the laboratory under section 1833(h) 
or 1848 of such Act (42 U.S.C. 1395l(h) or 1395w–4), 
as if such specimen had been collected directly by the lab-
oratory. 
(b) COVERED COMPLEX DIAGNOSTIC LABORATORY 
TEST DEFINED.—For purposes of this section, the term 
‘‘covered complex diagnostic laboratory test’’ means an 
analysis— 
(1) of DNA, RNA, chromosomes, proteins, or 
metabolites that detects genotypes, mutations, chro-
mosomal changes, biochemical changes, cell re-
sponse, or gene expression or is a cancer chemo-
VerDate Nov 24 2008 
02:56 Mar 26, 2009
Jkt 079200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H1699.IH
H1699
smartinez on PROD1PC64 with BILLS
therapy sensitivity assay, but does not include meth-
ods principally comprising immunohistochemistry, 
flow cytometry, enzyme assay or immunoassay; 
(2) that is described in section 1861(s)(3) of 
the Social Security Act (42 U.S.C. 1395x(s)(3)); 
(3) that is developed and performed by a lab-
oratory which is independent of the hospital in which 
the specimen involved was collected and not under 
any arrangements (as defined in section 1861(w)(1) 
of such Act (42 U.S.C. 1395x(w)(1)); and 
(4) that is not furnished by the hospital where 
the specimen was collected to a patient of such hos-
pital, directly or under arrangements (as defined in 
section 1861(w)(1) of such Act (42 U.S.C. 
1395x(w)(1)) made by such hospital. 
SEC. 4. EFFECTIVE DATE. 
The provisions of section 3 shall apply to tests fur-
nished on or after the date of the enactment of this Act. 
Æ 
VerDate Nov 24 2008 
02:56 Mar 26, 2009
Jkt 079200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6301
E:\BILLS\H1699.IH
H1699
smartinez on PROD1PC64 with BILLS