42 CFR §493.47

1. (a)A certificate for PPM procedures is required—
   1. (1)Initially for all laboratories performing test procedures specified as PPM procedures; and
   2. (2)For all certificate of waiver laboratories that intend to perform only test procedures specified as PPM procedures in addition to those tests listed in § 493.15(c).
2. (b)HHS will issue a certificate for PPM procedures if the laboratory—
   1. (1)Complies with the requirements of § 493.43; and
   2. (2)Remits the fee for the certificate, as specified in subpart F of this part.
3. (c)Laboratories issued a certificate for PPM procedures are subject to—
   1. (1)The notification requirements of § 493.53;
   2. (2)The applicable requirements of this subpart and subparts H, J, K, and M of this part; and
   3. (3)Inspection only under the circumstances specified under §§ 493.1773 and 493.1775, but are not routinely inspected to determine compliance with the requirements specified in paragraphs (c) (1) and (2) of this section.
4. (d)In accordance with subpart R of this part, HHS will initiate suspension, limitation, or revocation of a laboratory's certificate for PPM procedures for failure to comply with the applicable requirements set forth in this subpart. HHS may also impose certain alternative sanctions. In addition, failure to meet the requirements of this subpart may result in suspension of all or part of payments under Medicare and Medicaid, as specified in subpart R of this part.
5. (e)A certificate for PPM procedures is valid for a period of no more than 2 years.