C.F.R. » Title 42 » CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER G—STANDARDS AND CERTIFICATION › PART 493—LABORATORY REQUIREMENTS › Subpart R—Enforcement Procedures

42 C.F.R. § 493.1842

Cancellation of Medicare approval

Read at: eCFRecfr.gov CornellLII GovInfogovinfo.gov CasesGoogle Scholar

(a) Basis for cancellation. (1) CMS always cancels a laboratory's approval to receive Medicare payment for its services if CMS suspends or revokes the laboratory's CLIA certificate.

(2) CMS may cancel the laboratory's approval under any of the following circumstances:

(i) The laboratory is out of compliance with a condition level requirement.

(ii) The laboratory fails to submit a plan of correction satisfactory to CMS.

(iii) The laboratory fails to correct all its deficiencies within the time frames specified in the plan of correction.

(b) Notice and opportunity to respond. Before canceling a laboratory's approval to receive Medicare payment for its services, CMS gives the laboratory—

(1) Written notice of the rationale for, effective date, and effect of, cancellation;

(2) Opportunity to submit written evidence or other information against cancellation of the laboratory's approval.

This sanction may be imposed before the hearing that may be requested by a laboratory, in accordance with the appeals procedures set forth in § 493.1844.

(c) Effect of cancellation. Cancellation of Medicare approval terminates any Medicare payment sanctions regardless of the time frames originally specified.

Notes of Decisions
Cited in 2 cases (1 in the last 5 years), 2002–2021 · leading case: Michele Yates v. Pinellas Hematology & Oncology, P.A., 21 F.4th 1288 (11th Cir. 2021).
Sort: Relevance Newest Treatment
Michele Yates v. Pinellas Hematology & Oncology, P.A., 21 F.4th 1288 (11th Cir. 2021). “” 42 C.F.R. § 493.1842 (a)(1). And Med- icare’s claims processing manual indicates that “[t]he CLIA mandates that vir- tually all laboratories, including physician office laboratories (POLs) .”
Oakland Med. Grp., P.C., Harold Margolis, D.O. v. Sec'y of Health & Human Servs., Health Care Fin. Admin., 298 F.3d 507 (6th Cir. 2002). · cites it 3× “See 42 C.F.R. § 493.1842 (a)(1) (West 2002); see also 42 U.”
Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.