Section 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.

The provisions of this § 1243.41 adopted December 5, 1980, effective December 1, 1980, 10 Pa.B. 4614; amended September 5, 2008, effective September 6, 2008, 38 Pa.B. 4898. Immediately preceding text appears at serial pages (276177) to (276178).

Notation

Authority

The provisions of this section are amended under sections 201(2), 403 and 443.3 of the Public Welfare Code (62 P. S. § § 201(2), 403 and 443.3).

Cross References

This section cited in 55 Pa. Code § 1243.52 (relating to payment conditions for various services).