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.
Notes
The
provisions of this § 1243.42 adopted December 5, 1980, effective
12/1/1980, 10 Pa.B. 4614;
amended September 5, 2008, effective 9/6/2008, 38 Pa.B.
4898.
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).
This section cited in 55 Pa. Code §
1243.71 (relating to scope of
claims review procedures).
