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-
1395hh h), 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.
Notes
The
provisions of this § 1243.41 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 §
1243.52 (relating to payment
conditions for various services).
