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108th CONGRESS
2d Session
H. R. 5311
To amend title XVIII of the Social Security Act to provide
whistleblower protection to employees of clinical laboratories who
furnish services under the Medicare Program, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
October 8, 2004
Mr. Cummings 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
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A BILL
To amend title XVIII of the Social Security Act to provide
whistleblower protection to employees of clinical laboratories who
furnish services under the Medicare Program, and for other purposes.
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 ``Clinical Laboratory Compliance
Improvement Act of 2004''.
SEC. 2. PROTECTION OF EMPLOYEES OF PROVIDERS AND SUPPLIERS OF CLINICAL
DIAGNOSTIC LABORATORY TESTS WHO REPORT VIOLATIONS.
(a) In General.--Section 1846 of the Social Security Act (42 U.S.C.
1395w-2) is amended by adding at the end the following new subsection:
``(c)(1)(A) Each provider or clinical laboratory approved for
participation under this title to provide clinical diagnostic
laboratory tests shall post in a conspicuous place a notice to
employees that indicates the manner in which to report instances of
noncompliance with conditions of participation under this title of the
provider or laboratory (as the case may be), including deficiencies
with respect to testing, quality, and inadequately trained personnel.
``(B)(i) A notice under subparagraph (A) shall include--
``(I) the name and contact information of the appropriate
entity, accreditation organization, or State or Federal agency
to report instances of noncompliance; and
``(II) a description of the rights and protections under
this section of individuals who report instances of
noncompliance.
``(ii) The Secretary shall specify the form of the notice.
``(2)(A) A provider or clinical laboratory approved for
participation under this title to provide clinical diagnostic
laboratory tests shall not discriminate or retaliate in any manner
against any employee of the provider or laboratory (as the case may be)
because that employee, or any other person, has presented a grievance
or complaint, or has initiated or cooperated in any investigation or
proceeding of any kind, relating to the clinical diagnostic laboratory
tests performed by the provider or laboratory (as the case may be) or
other requirements and prohibitions of this title.
``(B) An employee of a provider or clinical laboratory approved for
participation under this title to provide clinical diagnostic
laboratory tests who has been discriminated or retaliated against in
employment in violation of this subsection may initiate judicial action
in a United States District Court and shall be entitled to
reinstatement, reimbursement for lost wages and work benefits caused by
the unlawful acts of the employing provider or laboratory (as the case
may be). Prevailing employees are entitled to reasonable attorney's
fees and costs associated with pursuing the judicial action.
``(C) No action may be brought under subparagraph (B) more than 2
years after the discrimination or retaliation with respect to which the
action is brought.
``(D) For purposes of this paragraph--
``(i) an adverse employment action shall be treated as
`retaliation or discrimination'; and
``(ii) an adverse employment action includes--
``(I) the failure to promote an individual or
provide any other employment-related benefit for which
the individual would otherwise be eligible;
``(II) an adverse evaluation or decision made in
relation to accreditation, certification,
credentialing, or licensing of the individual; and
``(III) a personnel action that is adverse to the
individual concerned.''.
(b) Clerical Amendment.--The heading of such section is amended by
adding at the end the following:
``; whistleblower protections''.
(c) Effective Date.--The amendment made by subsection (a) shall
take effect January 1, 2005.
SEC. 3. REQUIREMENT FOR UNANNOUNCED SURVEYS.
(a) In General.--Section 1846 of the Social Security Act (42 U.S.C.
1395w-2), as amended by section 2(a), is further amended by adding at
the end the following new subsections:
``(d)(1) Upon receipt of a report of an instance of noncompliance
with conditions of participation by a provider or clinical laboratory
approved for participation under this title to provide clinical
diagnostic laboratory tests, the investigative organization shall--
``(A) provide notice to the Secretary and other
investigative organizations involved of receipt of the report
within 3 business days of such receipt using a standard format
and manner of transmission developed by the Secretary for such
purpose;
``(B) promptly determine whether to investigate the report;
and
``(C) if appropriate, promptly investigate the report.
``(2) In measuring performance of an investigative organization
under a contract entered into with the Secretary, the Secretary shall
provide for appropriate adjustments to payments under the contract for
failure to carry out the responsibilities of this subsection.
``(3) In this subsection, the term `investigative organization'
means an accreditation organization, a State agency, or other entity
responsible for surveys of such providers or clinical laboratories.
``(e)(1) Each provider or clinical laboratory approved for
participation under this title to provide clinical diagnostic
laboratory tests shall be subject to a standard survey, to be conducted
without any prior notice to the provider or laboratory (as the case may
be). Each survey shall include verification of compliance with
requirements under subsection (c).
``(2) Any individual who notifies (or causes to be notified) a
provider or laboratory of the time or date on which such a survey is
scheduled to be conducted is subject to a civil money penalty not to
exceed $2,000.
``(3) The Secretary shall review each State's procedures for the
scheduling and conduct of standard surveys to assure that the State has
taken all reasonable steps to avoid giving notice of such a survey
through the scheduling procedures and the conduct of the surveys
themselves.
``(f) The Secretary shall submit to Congress an annual report on
the actions taken under this section. Each such report shall include
information on reports made under subsection (c), actions taken under
subsection (d), the promptness with which such actions were taken, the
findings of any investigation of such reports, and any actions taken
based upon such findings.''.
(b) Clerical Amendment.--The heading of such section, as amended by
section 2(b), is further amended by adding at the end the following:
``; unannounced surveys''.
(c) Effective Date.--The amendment made by subsection (a) shall
take effect January 1, 2005.
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