SUBJECT:

James G. Morgan, D.O., Laboratory Director,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION DISMISSING HEARING REQUEST

For the reasons set forth below, I conclude that Petitioner, James G. Morgan, D.O., is not entitled to a hearing because his hearing request was not timely filed. I therefore grant the motion of the Centers for Medicare & Medicaid Services (CMS) to dismiss the hearing request.

It appears that Petitioner operated a clinical laboratory as part of his medical practice. See CMS Exhibit (Ex.) 5. On June 17, 2005, the Michigan Department of Community Health completed an inspection of Petitioner's laboratory pursuant to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and found noncompliance at the immediate jeopardy level. In a notice dated June 22, 2005, CMS advised Petitioner that, based on those survey findings, it would impose the following remedies: suspension of the laboratory's CLIA certificate and cancellation of its approval to receive Medicare payments. CMS Ex. 1. The notice informed Petitioner that the suspension and cancellation would be effective June 29, 2005, if the immediate jeopardy had not been removed by that date. Id. CMS also informed Petitioner that the laboratory's CLIA certificate would be revoked if the laboratory did not achieve compliance with all CLIA conditions within 60 days. Id. Finally, the notice informed Petitioner that he could request a hearing within 60 days by writing either to CMS or to the Departmental Appeals Board. Id. Petitioner responded to the June 22 notice in a letter dated June 28, 2005. CMS Ex. 5. In a letter dated July 6, 2005, CMS notified Petitioner that the remedies of suspension of the CLIA certificate and cancellation of approval to receive Medicare payments had been imposed. CMS Ex. 6. In a letter dated August 26, 2005, CMS notified Petitioner that the laboratory's CLIA certificate was revoked. CMS Ex. 2. Petitioner requested a hearing by letter dated September 2, 2005. CMS Ex. 3.

CMS has moved to dismiss this case, arguing that Petitioner failed timely to file his request for hearing. In support of its motion to dismiss, CMS attached six exhibits, CMS Exs.1-6. Petitioner did not respond to the motion, and the time for response has since passed. In the absence of objection, I have admitted CMS Exs. 1-6 into the record.

1. Petitioner is not entitled to a hearing because he did not file a timely hearing request. ⁽¹⁾

CLIA establishes requirements for all laboratories that perform clinical diagnostic tests on human specimens and provides for federal certification of such laboratories. Pub. L. No. 100-578, amending � 353 of the Public Health Service Act, codified at 42 U.S.C. � 263a et seq. The purpose of CLIA requirements is to ensure the accuracy and reliability of laboratory tests, and hence the health and safety of those tested. See H.R. Rep. No. 899, 100th Cong. 2d Sess. 8 (1988), reprinted in 1988 U.S.C.C.A.N. 3828, 3829.

Generally, a laboratory that is performing tests of high and/or moderate complexity must have a certificate, such as a certificate of compliance, and must meet applicable conditions of certification set out in subparts F, H, J, K, M, P, and Q of Part 493. ⁽²⁾ 42 C.F.R. �� 493.5, 493.20. Each condition represents a general requirement that must be met for certification. Standards are the specific components of the conditions, and failure to meet one or more standards may be so serious as to constitute a failure to comply with the conditions of certification. Edison Medical Laboratories, Inc., DAB No. 1713, at 2 (1999).

If a laboratory is found to have condition-level deficiencies that pose immediate jeopardy, CMS requires the laboratory to take immediate action to remove the jeopardy and may impose one or more alternative sanctions. If the findings of a revisit indicate that a laboratory has not eliminated the immediate jeopardy, CMS may suspend or limit and later revoke the laboratory's CLIA certificate. 42 C.F.R. � 493.1812. "Immediate jeopardy" is defined as "a situation in which immediate corrective action is necessary because the laboratory's noncompliance with one or more condition level requirements has already caused, is causing, or is likely to cause, at any time, serious injury or harm, or death, to individuals served by the laboratory or to the health or safety of the general public. . . ." 42 C.F.R. � 493.2.

A laboratory is entitled to a hearing before an ALJ to contest the imposition of CLIA remedies. The determination as to which alternative sanctions to impose, the amount of any CMP, and the determination that a laboratory's deficiencies pose immediate jeopardy are not appealable. The CLIA regulations incorporate by reference the hearing procedures and the request for review provisions in 42 C.F.R. Part 498, subparts D and E. 42 C.F.R. � 493.1844.

Pursuant to 42 C.F.R. � 498.40(a)(2), a request for hearing must be filed within 60 days "from receipt of the notice of initial, reconsidered, or revised determination." In the present case, CMS notified Petitioner of the imposition of remedies in a letter dated June 22, 2005. CMS Ex. 1. Assuming five days for mailing, Petitioner would have received the notice letter not later than June 27, 2005. Based on that assumption, a timely hearing request would need to have been filed not later than August 26, 2005. Petitioner's hearing request was dated September 2, 2005, which is beyond the 60-day deadline. I am permitted, pursuant to 42 C.F.R. � 498.40(c)(2), to extend the deadline for filing a hearing request upon a showing of "good cause." Petitioner did not respond to CMS's motion to dismiss. By failing to respond, Petitioner has, in essence, conceded that no good cause exists for his failure to file his hearing request timely. Therefore, I conclude that Petitioner's hearing request was not filed within 60 days and that no good cause has been shown for extending the time for filing. Accordingly, this case is dismissed pursuant to 42 C.F.R. � 498.70(c).

Carolyn Cozad Hughes

Administrative Law Judge

1. There being no dispute of fact in this case, I make this one conclusion of law.

2. A laboratory performing only simple laboratory examinations and procedures may operate under a certificate of waiver if it meets the requirements of subpart B of Part 493.