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PA Bulletin, Doc. No. 07-683



[55 PA. CODE CHS. 1150 AND 1243]

Clinical Laboratory Improvement Amendments

[37 Pa.B. 1865]
[Saturday, April 21, 2007]

   The Department of Public Welfare (Department), under the authority of sections 201(2), 403 and 443.3 of the Public Welfare Code (62 P. S. §§  201(2), 403 and 443.3), proposes to amend Chapters 1150 and 1243 (relating to MA Program payment policies; and outpatient laboratory services) to read as set forth in Annex A.

Purpose of Proposed Rulemaking

   The proposed amendments to Chapters 1150 and 1243 amend current Medical Assistance (MA) regulations to be consistent with the Clinical Laboratory Improvement Amendments of 1988 (CLIA).


   Under the CLIA, specifically 42 U.S.C.A. § 263a, regarding certification of laboratories, the United States Department of Health and Human Services (HHS) was required to establish certification requirements for laboratories performing tests on human specimens and to certify through the issuance of a certificate that those laboratories meet the requirements established by the HHS. Further, 42 CFR Part 493 (relating to laboratory requirements) sets forth the certification requirements and establish uniform certification requirements for laboratories, regardless of location, size or type of testing performed. Section 263a of the U.S.C.A. applies to laboratories that examine human specimens for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of human beings.

   The provisions in 42 U.S.C.A. § 263a(f) also specify performance requirements, based on test complexity and risk factors related to erroneous test results. This section also provides requirements that ensure the quality of laboratory services and support the best interest of public health.

   The purpose of the CLIA and the Federal regulations is to ensure that appropriate standards are established to ensure quality laboratory testing to improve the diagnosis of disease, management of care for treatment and assessment of health of patients and to avoid or eliminate test errors that might result in patient harm. In addition, both 42 U.S.C.A. § 263a(b) and the Federal regulations require that laboratories have a CLIA identification number and a CLIA certificate identifying those laboratory procedures the laboratory is eligible to perform.

   A State Medicaid agency may only pay for laboratory services performed by laboratories that have CLIA certification. (See 42 U.S.C.A. § 1396a(a)(9)(C), regarding state plan for medical assistance, and 42 CFR 493.1809 (relating to limitation on Medicaid payment).) The Department is now amending its regulations to reflect this Federal requirement.


   Under existing MA regulation, the Department limited MA payment to hospital and independent laboratories enrolled in the MA Program. The Department will adopt the CLIA definition of ''laboratory'' and include hospital laboratories and privately owned laboratories under the same definition, thus the term ''independent laboratory'' is obsolete.

   The Department proposes to amend the following sections to be consistent with the CLIA:

   Section 1150.57(d) (relating to diagnostic services and radiation therapy) by deleting the reference to an independent laboratory.

   Section 1243.1 (relating to policy) by deleting the reference to independent laboratories.

   Section 1243.2 (relating to definitions) by deleting the definition of ''independent laboratory'' and by adding the definitions of ''CLIA'' and ''laboratory.''

   Sections 1243.41(1), (3) and (4), 1243.42(1) and (3), 1243.52(a) and 1243.54(3) are amended to incorporate CLIA requirements and definitions.

Individuals and Organizations

   The proposed rulemaking requires laboratories participating in the MA Program to meet CLIA certification requirements established by the HHS.

Accomplishments and Benefits

   The Department's adoption of the CLIA definition of ''laboratory'' will include hospital and privately owned laboratories under the same definition. This amendment will help ensure consistency across the MA Program, both for laboratory providers and for laboratory services provided to MA recipients. In addition, the amendments will be consistent with Federal requirements for participating laboratories.

Fiscal Impact

   Laboratories should already be in compliance with Federal law and regulations; therefore, there is no anticipated fiscal impact.

Paperwork Requirements

   There are no additional reports, paperwork or new forms needed to comply with the proposed rulemaking.

Effective Date

   This proposed rulemaking will be effective upon final-form publication in the Pennsylvania Bulletin.

Public Comment

   Interested persons are invited to submit written comments, suggestions or objections regarding the proposed rulemaking to the Department of Public Welfare, Office of Medical Assistance Programs, Attention: Regulations Coordinator, c/o Deputy Secretary's Office, Room 515, Health and Welfare Building, Harrisburg, PA 17120 within 30 calendar days after publication of this proposed rulemaking in the Pennsylvania Bulletin. Reference Regulation No. 14-508 when submitting comments.

   Persons with a disability who require an auxiliary aid or service may submit comments by using the AT&T Relay Service, (800) 654-5984 (TDD users) or (800) 654-5988 (voice users).

Regulatory Review Act

   Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on April 11, 2007, the Department submitted a copy of this proposed rulemaking and a copy of a Regulatory Analysis Form to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the House Committee on Health and Human Services and the Senate Committee on Public Health and Welfare. A copy of this material is available to the public upon request.

   Under section 5(g) of the Regulatory Review Act, IRRC may convey any comments, recommendations or objections to the proposed rulemaking within 30 days of the close of the public comment period. The comments, recommendations or objections must specify the regulatory review criteria which have not been met. The Regulatory Review Act specifies detailed procedures for review, prior to final publication of the rulemaking, by the Department, the General Assembly and the Governor of comments, recommendations or objections raised.


   Fiscal Note: 14-508. No fiscal impact; (8) recommends adoption.

Annex A





§ 1150.57. Diagnostic services and radiation therapy.

*      *      *      *      *

   (d)  A practitioner may bill for laboratory services performed in the office only if the practitioner is licensed by the Department of Health and enrolled in the MA Program as [an independent] a laboratory.

*      *      *      *      *


§ 1243.1. Policy.

   The MA Program provides payment for specific outpatient laboratory services rendered to eligible recipients by [hospital and independent] laboratories enrolled as providers under the [program] Program. Payment for outpatient laboratory services is subject to this chapter and Chapters 1101 and 1150 (relating to general provisions; and MA Program payment policies) and the MA Program fee schedule.

§ 1243.2. Definitions.

   The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:

   CLIA--The Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C.A. § 263a).

   [Independent laboratory--A laboratory that is licensed by the Department of Health and which is not affiliated with the medical practitioners it serves.]

   Laboratory--A facility for the biological, microbiological, serological, chemical, immunohema- tological, hematological, biophysical, cytological, pathological or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings. These examinations also include procedures to determine, measure or otherwise describe the presence or absence of various substances or organisms in the body. Facilities only collecting or preparing specimens, or both, or only serving as a mailing service and not performing testing are not considered laboratories.

*      *      *      *      *


§ 1243.41. Participation requirements.

   In addition to the participation requirements established in Chapter 1101 (relating to general provisions) laboratories shall meet the requirements of this subsection:

*      *      *      *      *

   (1)  [Hospital and independent laboratories whether in or out-of-State shall, at the time of enrollment, submit to the Bureau of Provider Relations, a list of the diagnostic procedures that are Medicare approved to perform and the fee currently charged to the general public for each of the procedures. Each procedure shall be identified in accordance with the Uniform Procedure Terminology (UPT) Code used by Medicare and Pennsylvania Blue Shield.] Each laboratory, whether in or out-of-State, shall submit the following to the Department:

   (i)  A copy of its CLIA certificate.

   (ii)  A copy of its CLIA identification number.

   (iii)  A list of diagnostic procedures that the laboratory is CLIA-certified to perform with the corresponding Healthcare Common Procedure Coding System (HCPCS) codes.

   (iv)  The fee currently charged to the general public for each of the procedures.

*      *      *      *      *

   (3)  [Independent laboratories] A laboratory shall be currently licensed by the Department of Health, [Division] Bureau of Laboratories and be Medicare certified under Title XVIII, or certified as meeting standards comparable to those of Medicare.

   (4)  Out-of-State [hospital and independent] laboratories shall meet the applicable requirements established in paragraphs (1) and (2) and shall sign the [outpatient] provider agreement designated by the Department.

§ 1243.42. Ongoing responsibilities of providers.

   In addition to the ongoing responsibilities established in § 1101.51(a)--(e) (relating to ongoing responsibilities of providers), laboratories shall, as a condition of participation, comply with the following requirements:

   (1)  Promptly report [changes in laboratory fees or procedures and the dates the changes became effective to the Bureau of Provider Relations] to the Department changes in the laboratory's CLIA certification, including changes in the type of CLIA certificate, changes in laboratory fees or procedures and the effective date of these changes.

*      *      *      *      *

   (3)  [Independent laboratories] Laboratories shall avoid locked-in referral arrangements between themselves and a prescriber.


§ 1243.52. Payment conditions for various services.

   (a)  If a laboratory refers work to another laboratory, payment will be made to either the referring laboratory or the laboratory actually performing the test. Payment will be made only if the laboratory billing the Department is currently participating in the MA Program and has listed the diagnostic procedure being billed with the [Bureau of Provider Relations] Department as specified in § 1243.41(1) (relating to participation requirements).

*      *      *      *      *

§ 1243.54. Noncompensable services.

   Payment will not be made to a laboratory for the following services regardless of where or to whom they are provided:

*      *      *      *      *

   (3)  Procedures that the laboratory is not CLIA-certified to perform.

[Pa.B. Doc. No. 07-683. Filed for public inspection April 20, 2007, 9:00 a.m.]

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