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PA Bulletin, Doc. No. 08-1624




[55 PA. CODE CHS. 1150 AND 1243]

Clinical Laboratory Improvement Amendments

[38 Pa.B. 4898]
[Saturday, September 6, 2008]

   The Department of Public Welfare (Department), by this order, adopts the amendments set forth at 37 Pa.B. 1865 (April 21, 2007) 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).

Purpose of the Final-Form Rulemaking

   The purpose of this final-form rulemaking is to amend current Medical Assistance (MA) regulations set forth in Chapters 1150 and 1243 (relating to MA program payment policies; and outpatient laboratory services) 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 establishes uniform certification requirements for laboratories, regardless of location, size or type of testing performed. The provisions of 42 U.S.C.A. § 263a apply 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 the 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.


   A complete description of the amendment was published at 37 Pa.B. 1865 (April 21, 2007).

Affected Individuals and Organizations

   The final-form 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 final-form rulemaking will help ensure consistency across the MA Program, both for laboratory providers and for laboratory services provided to MA recipients. In addition, the final-form rulemaking 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 final-form rulemaking.

Public Comment

   Written comments, suggestions and objections regarding the proposed rulemaking were requested within a 30-day period following publication of the proposed rulemaking. No public comments were received within the 30-day time frame. The Independent Regulatory Review Commission (IRRC) did not comment on the proposed amendments.

Regulatory Review Act

   Under section 5.1(a) of the Regulatory Review Act (71 P. S. § 745.5a(a)), on June 20, 2008, the Department submitted a copy of this final-form rulemaking to IRRC and to the Chairpersons of the House Committee on Health and Human Services and the Senate Committee on Public Health and Welfare (Committees). No comments were received on the proposed amendments.

   In accordance with section 5.1(j.1) and (j.2) of the Regulatory Review Act, this final-form rulemaking was deemed approved by the Committees on July 22, 2008.

   Under section 5(g) of the Regulatory Review Act, the final-form rulemaking was deemed approved effective July 23, 2008.

   In addition to submitting the final-form rulemaking, the Department provided IRRC and the Committees with a copy of a Regulatory Analysis Form prepared by the Department. A copy of this form is available to the public upon request.


   The Department finds that:

   (1)  Public notice of intention to amend the administrative regulations by this order has been given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) (45 P. S. §§ 1201 and 1202) and the regulations promulgated there under, 1 Pa. Code §§ 7.1 and 7.2.

   (2)  The adoption of this final-form rulemaking in the manner provided by this order is necessary and appropriate for the administration and enforcement of the Public Welfare Code (62 P. S. §§ 101--1412).

   The Department acting under sections 201(2), 403 and 443.3 of the Public Welfare Code, orders that:

   (a)  The regulations of the Department, 55 Pa. Code Chapters 1150 and 1243, are amended by amending §§ 1150.57, 1243.1, 1243.2, 1243.41, 1243.42, 1243.52 and 1243.54 to read as set forth in Annex A.

   (b)  The Secretary of the Department shall submit this order and Annex A to the Offices of General Counsel and Attorney General for approval as to legality and form as required by law.

   (c)  The Secretary of the Department shall certify and deposit this order and Annex A with the Legislative Reference Bureau as required by law.

   (d)  This order shall take effect upon final publication in the Pennsylvania Bulletin.


   (Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 38 Pa.B. 4449 (August 9, 2008).)

   Fiscal Note: Fiscal Note 14-508 remains valid for the final adoption of the subject regulations.

Annex A





§ 1150.57.  Diagnostic services and radiation therapy.

   (a)  The fees for diagnostic radiology, nuclear medicine, radiation therapy, pathology and medical diagnostic procedures are comprised of a total fee, which is divided into a professional component fee and a technical component fee.

   (b)  The technical component of any diagnostic services provided on an inpatient basis will be included in the hospitals' payment for inpatient services. No other payment will be made for the total component or technical component for inpatient services.

   (c)  Physicians may bill for a visit in addition to the professional component if an appropriate medical care visit is provided. However, a visit to a practitioner's office or the outpatient department of a hospital solely for the purpose of receiving a diagnostic service or radiation therapy does not qualify for payment for a visit and the diagnostic service or radiation therapy. In this kind of situation, payment is made only for the diagnostic service or 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 a laboratory.

   (e)   A practitioner may bill for medical diagnostic, surgical diagnostic, diagnostic radiology, nuclear medicine and radiation therapy in addition to:

   (1)  A surgical procedure.

   (2)  A medical care visit if the situation described in subsection (c) does not occur.


§ 1243.1.  Policy.

   The MA Program provides payment for specific outpatient laboratory services rendered to eligible recipients by laboratories enrolled as providers under the 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).

   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.

   Panel test--A series of diagnostically related laboratory tests ordered by a practitioner to confirm a presumptive diagnosis.


§ 1243.41.  Participation requirements.

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

   (1)  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.

   (2)  For hospital laboratories, the hospital shall be currently Medicare certified or currently certified by the Department of Health as meeting standards comparable to those of Medicare.

   (3)  A laboratory shall be currently licensed by the Department of Health, Bureau of Laboratories and be Medicare certified under Title XVIII (42 U.S.C.A. §§ 1395--1395hhh), or certified as meeting standards comparable to those of Medicare.

   (4)  Out-of-State laboratories shall meet the applicable requirements established in paragraphs (1) and (2) and shall sign the 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 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.

   (2)  Permit authorized State and Federal officials or their authorized agents to conduct onsite reviews for the purpose of verification of information furnished as a basis for payment under the MA Program. During the course of the review, the reviewers shall be allowed access to the laboratory area. The provider shall also allow reviewers access to laboratory procedure manuals and any records or documents necessary to determine whether payment for services that have or are being provided comply with Federal and State laws and regulations. The reviewers shall be allowed to photograph, photocopy or duplicate the manuals, records, and documents. Onsite reviews shall be conducted during the normal hours of operation or at another time mutually agreeable to the officials and the provider.

   (3)  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 Department as specified in § 1243.41(1) (relating to participation requirements).

   (b)  Laboratory procedures billed to the Department will be based on a written request of the practitioner. The written request must include the following:

   (1)  The name of the practitioner, the Medical Assistance Identification (M.A.I.D.) number of the practitioner or the DEA number of the practitioner.

   (2)  The name of the recipient.

   (3)  The case number of the recipient.

   (4)  The date of the request.

   (5)  The handwritten signature of the practitioner or the designee of the practitioner.

   (c)  Preadmission laboratory tests performed by a hospital laboratory shall be included in the inpatient billing of the hospital. If the recipient is not admitted for some reason, the preadmission laboratory tests shall be billed as an outpatient claim.

§ 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:

   (1)  Procedures not listed in the fee schedule in the MA Program fees schedule.

   (2)  Travel to a recipient's place of residence to collect a specimen. The provider will be reimbursed for performing the procedure if it is compensable; however, no extra payment will be made for mileage.

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

[Pa.B. Doc. No. 08-1624. Filed for public inspection September 5, 2008, 9:00 a.m.]

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