[Congressional Record Volume 155, Number 85 (Tuesday, June 9, 2009)]
[Senate]
[Pages S6382-S6383]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. SPECTER (for himself and Mr. Wyden):
  S. 1220. 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; to the Committee on Finance.
  Mr. SPECTER. Mr. President, I have sought recognition today to 
introduce The Patient Access to Critical Lab Tests Act. The legislation 
would modernize Medicare billing rules to improve beneficiary access to 
important, life-saving advanced diagnostic technologies.
  Mapping the human genome has enabled revolutionary advances in 
understanding a wide variety of diseases, and ushered in an era where 
treatments can be tailored to individual patients based on their DNA 
and specific molecular character of their disease. Complex diagnostic 
laboratory tests make such ``personalized medicine'' possible. By 
understanding the molecular nature of

[[Page S6383]]

disease, these new technologies increasingly allow clinicians and 
patients to pick individualized treatment options, rather than basing 
treatment choices on broad assessments of what works best for a 
population.
  Unfortunately Medicare payment, coding and coverage practices are 
harming Medicare beneficiary access to specialized diagnostic tests. In 
particular is the Centers for Medicare and Medicaid Services, CMS, 
Medicare ``date of service'' regulation. Under the regulation, any test 
furnished within 14 days after the patient's discharge from a hospital 
is deemed to have been performed on the day of collection, when the 
patient was in or at the hospital, even though the patient may no 
longer be at the hospital when the test is ordered, and the test is not 
used to guide treatment during the patient's hospital encounter. A 
laboratory test that is deemed to coincide with the date on which the 
patient was a hospital patient becomes a service furnished by the 
hospital, even though the hospital may have nothing to do with the 
ordering, performance, or use of the test.
  The combination of these rules creates a host of administrative and 
financial disincentives for hospitals to embrace these tests.
  Hospitals are required to exercise professional responsibility over 
these services, but are unwilling to do so for tests that are not 
offered by the hospital, and which are, in fact, offered by 
laboratories that are otherwise unaffiliated with and unfamiliar to the 
hospital.
  Hospitals are required to bill for the service; the laboratories may 
not bill Medicare directly, and instead must bill the hospital for the 
services they provide, which means the hospital assumes the financial 
risk that the service is covered and that Medicare will pay for it.
  In light of these administrative and financial disincentives, 
hospitals are encouraging physicians to delay ordering the tests until 
after the 14 days; others are cancelling orders altogether. These 
disincentives create obstacles for physicians and their patients, and 
genuine barriers to access these beneficial tests.
  These rules also create substantial hardship for the laboratories 
that are seeking to develop these tests. In order for the tests to be 
covered, hospitals must enter into agreements with the laboratories 
furnishing the tests. It is administratively overwhelming for these 
small laboratories to seek to enter into agreements with all potential 
originating hospitals, which may number in the thousands when 
considering sites where tissue may be stored.
  The legislation that I am introducing today with Senator Wyden would 
require CMS to take a small, but important step toward facilitating 
Medicare beneficiary access to innovative, life-saving diagnostic tests 
by updating the ``date of service'' regulation. Specifically, the 
Patient Access to Critical Lab Tests Act would permit independent 
laboratories offering complex diagnostic laboratory tests to bill 
Medicare directly for tests performed anytime following a patient's 
hospital stay, without forcing the hospital into an unnecessary 
middleman role.
  Given the promise of these new technologies, it is important that all 
regulatory regimes keep pace with the rapidly evolving world of science 
and technology, and operate to promote innovation. Out-dated 
regulations and calcified regulatory agencies can stifle innovation and 
prevent new life-saving diagnostics and therapies from ever coming to 
market. They can also serve as a drag on our economy.
  Fixing this rule is a matter of critical importance to Medicare 
beneficiaries, as well as to the laboratories developing these 
technologies.
  I encourage colleagues to join Senator Wyden and me in cosponsoring 
this bill. I likewise urge Senators Baucus and Grassley to consider 
this important measure as part of health care reform.
  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 1220

       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 ``Patient Access to Critical 
     Lab Tests Act''.

     SEC. 2. FINDINGS; SENSE OF CONGRESS.

       (a) Findings.--The Congress finds as follows:
       (1) Timely access to laboratory testing is essential to 
     ensure quality of care for patients.
       (2) Genetic and molecular laboratory testing are the new 
     cornerstones of high quality, cost-effective preventive 
     medicine.
       (3) The completion of the Human Genome Project in 2003 
     paved the way for a more sophisticated understanding of 
     disease causation, which has contributed to the advent of 
     ``personalized medicine''.
       (4) Personalized medicine is the application of genomic and 
     molecular data to better target the delivery of health care, 
     facilitate the discovery and clinical 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 information to guide treatment 
     decisions.
       (6) Some of the most encouraging personalized medicine 
     developments involve highly specialized laboratory tests 
     that, using biomarkers and vast stores of historical data, 
     provide individualized information that enable physicians and 
     patients to develop personalized treatment plans.
       (7) Several outdated Medicare regulations for laboratory 
     billing are obstructing access to highly specialized 
     laboratory tests and delaying patients' diagnoses and 
     treatments. These same rules are discouraging investments in 
     development of new tests.
       (8) Realizing the promise of personalized medicine will 
     require improved regulation that appropriately encourages 
     development of and access to these specialized tests.
       (b) Sense of Congress.--It is the sense of Congress 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 bill for and be paid directly by 
     Medicare for furnishing 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 diagnostic laboratory 
     test, with respect to a specimen collected from an individual 
     during a period in which the individual 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 laboratory.
       (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, identifies, or quantitates genotypes, mutations, 
     chromosomal changes, biochemical changes, cell response, 
     protein expression, or gene expression or similar method or 
     is a cancer chemotherapy sensitivity assay or similar method, 
     but does not include methods principally comprising routine 
     chemistry or routine immunology;
       (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 laboratory 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 hospital, 
     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 furnished 
     on or after the date of the enactment of this Act.
                                 ______