Section 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.

The provisions of this § 1243.42 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 page (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 § 1243.71 (relating to scope of claims review procedures).