SUBJECT: Premium Diagnostic Laboratory, Inc.,

Petitioner,

Centers for Medicare and Medicaid Services

FINAL DECISION ON REVIEW OF

ADMINISTRATIVE LAW JUDGE DECISION

Premium Diagnostic Laboratory, Inc. (Petitioner), appealed an August 9, 2001 decision by Administrative Law Judge (ALJ) Steven T. Kessel dismissing Petitioner's request for a hearing (ALJ Decision). Petitioner had requested a hearing before the ALJ to contest the decision by the Centers for Medicare and Medicaid Services (CMS) to revoke its certificate issued under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The ALJ found that CMS's subsequent determination to rescind the revocation of Petitioner's CLIA certificate resulted in no appealable determination under the regulations and therefore dismissed Petitioner's request for a hearing.

Petitioner is an independent laboratory operating in California. On March 30, 2001, CMS sent a notice to Petitioner that CMS was proposing to impose sanctions on Petitioner, including the revocation of its CLIA certificate, because Petitioner was owned, operated, or directed by an individual who owned, operated, or directed a laboratory whose CLIA certificate had been revoked within the preceding two years. After Petitioner timely requested a hearing before an ALJ, CMS notified Petitioner on June 29, 2001, that it had determined not to pursue any sanctions against Petitioner and was withdrawing its determination to revoke Petitioner's CLIA certificate and to deny Petitioner Medicare payments.

The ALJ dismissed Petitioner's request for a hearing, finding that, after CMS's rescission of its sanctions, there was no initial determination from which Petitioner could take an appeal, and that since Petitioner had no right to a hearing, dismissal was appropriate under 42 C.F.R. � 498.70(b). The ALJ stated that the consequence of CMS's rescission of the sanctions was the elimination of the sanctions determination which was the basis for Petitioner's hearing request. The ALJ further noted that, even if CMS had not rescinded the sanctions and the ALJ had overturned CMS's determination, he could not have provided any greater relief to Petitioner than what had occurred as a result of CMS's withdrawal of its initial determination and sanctions. ALJ Decision at 3.

The record here includes the record before the ALJ, the ALJ Decision, and the parties' submissions on appeal. Our standard of review on a disputed conclusion of law is whether the ALJ Decision is erroneous. See, e.g., Lake Cook Terrace Nursing Center, DAB No. 1745 (2000). Our standard of review on a disputed finding of fact is whether the ALJ Decision is supported by substantial evidence on the record as a whole. Id.

On appeal Petitioner stated that it was entitled to a review by the ALJ of what it labeled an abuse of discretion by CMS in imposing sanctions against Petitioner. Petitioner asserted that CMS, at relevant times, failed to review documentation Petitioner supplied that demonstrated its compliance with CLIA regulations. Petitioner further argued that the ALJ's dismissal was "erroneous" and "not fair" to Petitioner because it deprived Petitioner of the opportunity to receive damages for CMS's inappropriate actions. Petitioner's Reply Brief at 2. Petitioner claimed that CMS, in revoking its CLIA certificate, had damaged Petitioner's reputation and violated its civil rights, as well as caused Petitioner to suffer financial hardship due to the loss of business revenue and costs incurred in contesting CMS's actions.

We find that the ALJ correctly determined that, with the withdrawal by CMS of the sanctions imposed on Petitioner, there was no longer any appealable determination before him. Actions that are appealable initial determinations under the CLIA regulations are set forth at 42 C.F.R � 493.1844(b). That regulation lists "actions" that are "initial determinations" and therefore subject to appeal, including the "revocation of the laboratory's CLIA certificate . . . because of non-compliance with CLIA requirements" and the "cancellation of the laboratory's approval to receive Medicare payments for its services." 42 C.F.R � 493.1844(b)(1) and (4). If those actions are subsequently rescinded in full, as they were here, there is no longer an initial determination in dispute and an ALJ may properly dismiss the request for a hearing. 42 C.F.R. � 498.70(b). The ALJ Decision cited Lakewood Plaza Nursing Center, DAB No. 1767 (2001), and Schowalter Villa, DAB No. 1688 (1999). Those decisions were based primarily on the language of 42 C.F.R. � 493.3(b)(12), which is not applicable here, but similarly addressed the situation where remedies had been fully rescinded and no relief could be granted as a result of an administrative proceeding.

Petitioner has not provided any legal basis for challenging the ALJ's decision to dismiss its hearing request, instead focusing on the unfairness of CMS's action and the harm Petitioner suffered as a result. While Petitioner may have experienced difficulties as a result of CMS's initial determination to revoke Petitioner's CLIA certificate and cancel its approval to receive Medicare payments, there is no authority in the regulations for the ALJ or the Board to provide the type of relief Petitioner is seeking. The ALJ found, and Petitioner did not deny, that the certificate was reinstated retroactively and that Medicare payments were paid retroactively for the period between the initial effective date of the cancellation and the date the laboratory closed and ceased operating. Thus, even if the ALJ found in Petitioner's favor on the merits, he could not grant any greater relief than was already given through the rescission. Petitioner received all of the relief that the ALJ had the authority to provide.

Conclusion

For the reasons discussed above, we sustain the ALJ's dismissal of Petitioner's request for a hearing. In doing so, we affirm and adopt all the FFCLs made by the ALJ.

Judith A. Ballard

M. Terry Johnson

Donald F. Garrett
Presiding Board Member