1. (1) Requirements. For MA certification, physician office laboratories, except as noted in sub. (2), shall be licensed pursuant to 42 CFR 493 (CLIA).
2. (2) Exception. Physician office laboratories servicing no more than 2 physicians, chiropractors or dentists, and not accepting specimens on referral from outside providers, are not required to be licensed under 42 CFR 493 (CLIA). These laboratories, however, shall submit an affidavit to the department declaring that they do not accept outside specimens.

3. (3) Medicare certification requirement. Physician office laboratories which accept referrals of 100 or more specimens a year in a specialty shall be certified to participate in medicare in addition to meeting the requirements under sub. (1).

   Note: For covered diagnostic testing services, see s. DHS 107.25.

History

History: Cr. Register, February, 1986, No. 362, eff. 3-1-86; correction in (1) and (2) made under s. 13.93 (2m) (b) 7., Stats., Register, December, 1999, No. 528.