Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division |
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IN THE CASE OF | |
Patricio Quines, as owner/operator of Premium Diagnostic Laboratory,
Inc., |
DATE: August 9, 2001 |
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Centers for Medicare & Medicaid
Services
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Docket No.C-01-058 Decision No. CR809 |
DECISION | |
DECISION DISMISSING I dismiss the request for hearing filed in this case by
Petitioner, Patricio Quines. I do so pursuant to 42 C.F.R. � 498.70(b)
because there is no initial determination from which an appeal may be
taken and, therefore, Petitioner has no right to a hearing. I. Background CMS (formerly known as the Health Care Financing Administration
or HCFA) alleged that Petitioner was an owner/operator of Premium Diagnostic
Laboratory, Inc. (Premium), an independent laboratory. By letter dated
March 30, 2000, CMS issued a notice of noncompliance and of proposed sanctions
to Premium for violation of certain Clinical Laboratory Improvement Amendments
of 1988 (CLIA) requirements. In this notice, CMS indicated it was taking
action to revoke Premium's CLIA certificate and to cancel its approval
to receive Medicare payments for services it performed after April 14,
2000. On October 11, 2000, CMS notified Petitioner that it was holding
him concurrently liable as an owner/operator of Premium Diagnostic Laboratory,
Inc., in connection with the sanction action against Premium. CMS stated
in an earlier letter dated September 11, 2000 that this meant that once
the revocation action in Premium was final, the CLIA prohibition against
the laboratory's owners, operators and director from owning, operating
or directing any laboratory for a period of at least two years from the
date of the revocation would apply to Petitioner. Petitioner timely requested a hearing. This case was assigned
to me for a hearing and a decision. However, by letter dated June 29,
2001, CMS notified Premium (and sent Petitioner a copy) that based on
additional information, CMS had determined that it would not pursue any
sanctions against Premium and was withdrawing its determination to revoke
the laboratory's CLIA certificate. By letter dated June 29, 2001, CMS
told Petitioner that CMS was not pursuing its action against Petitioner
inasmuch as the determination to impose sanctions against Petitioner was
corollary to CMS's sanction action against Premium. June 29, 2001 letter
from Wayne Moon, Director of CLIA Operations, to Patricio Quines. In a
separate cover letter dated June 29, 2001, counsel for
CMS stated that "since there is no longer a basis for a hearing," CMS
was requesting that this matter be dismissed for cause pursuant to 42
C.F.R. � 498.70(b) because in the absence of a CMS determination and sanction,
Petitioner has no right to a hearing. On July 1, 2001, Petitioner responded to CMS's letter
asserting his opposition to CMS's withdrawal of its determinations and
sanctions. Petitioner stated that while the action was welcome, it did
not address the specific issues raised in Petitioner's Motion for Summary
Judgment. In that motion Petitioner argued that CMS had no right to take
such a corollary action in the first instance against Petitioner where
there was no evidence that Petitioner was ever an owner or operator of
Petitioner. II. Issue, findings of fact and conclusions of law
The issue before me is whether Petitioner continues to have a right to a hearing where CMS has withdrawn all its determinations and proposed sanctions against Petitioner.
I make findings of fact and conclusions of law (Findings) to support my decision in this case. I set forth each finding below as a separately numbered heading. I discuss each finding in detail.
The June 29, 2001 letter to Petitioner from CMS plainly rescinds the initial determination that CMS made in this case. The letter specifically states -
June 29, 2001 letter from Wayne Moon, Director, CLIA Operations, to Patricio Quines.
In its original notice of remedy determination, CMS alleged
that Petitioner was an owner and or operator of Premium Diagnostic Laboratory.
Regulations which implement CLIA provide for a right to a hearing for
a laboratory that is the subject of a determination by CMS to impose sanctions
against it. The applicable regulations allow a laboratory dissatisfied
with an "initial determination" by CMS to request a hearing conducted
in accordance with 42 C.F.R. Part 498, Subpart D. 42 C.F.R. � 493.1844
(a)(1) - (3); 42 C.F.R. � 493.1844(b). However, the regulations do not
articulate a right to a hearing for an individual who is sanctioned in
the capacity of owner and operator of a laboratory. Had this case been
heard on the merits, I might have decided first whether Petitioner had
a right to a hearing in his capacity as the alleged owner and or operator
of a laboratory. However, it is unnecessary for me to address that issue
in this case. That is because Petitioner plainly does not have a right
to a hearing inasmuch as CMS determined to rescind its sanction determination
against Petitioner. Even if Petitioner had a right to a hearing in his capacity
as the alleged owner or operator of Premium that right would extend only
to challenging a sanction determination made by CMS. In this case, CMS's
rescission of its determinations to impose sanctions against Premium extinguished
those determinations. The consequence of CMS's action was to eliminate
completely the sanction determination which was the basis for Petitioner's
hearing request. Since no sanction determination exist now, there is no
"initial determination" which would give Petitioner a right to a hearing.
Lakewood Plaza Nursing Center, DAB CR691 (2000), aff'd DAB
No. 1767 (2001). As the Appellate Panel in Lakewood stated, "[o]nce
the initial determination and resulting remedy are rescinded ab initio,
there is literally no further remedial action that the ALJ can take under
the regulations." Lakewood Plaza Nursing Center, DAB No. 1767
(2001), at 6. Thus, the result is as if no determination had ever been
made. Petitioner opposes the motion to dismiss and contends
that I should consider his motion for summary judgment and render a decision
on the merits because the issues addressed in the motion may continue
to trouble him in the future. In his motion, Petitioner contends that
CMS's action against him was in error as CMS never had any jurisdiction
over him as he never held a CLIA certificate, nor was he ever an owner
or operator of Premium. However, the scope of my review in these matters
is very clearly proscribed and, unless there is an "initial determination"
subject to review by an administrative law judge under the regulations,
I have no authority to hear the matter. To decide the issues presented
by Petitioner outside the context of a dispute over which I have jurisdiction
would be advisory at best and well beyond the permissible scope of my
review.
Dismissal of a hearing request is appropriate where a party has no right to a hearing. 42 C.F.R. � 498.70(b). Here, dismissal is appropriate inasmuch as Petitioner has no right to a hearing because there is no "initial determination" for which a hearing may be requested. Therefore, I dismiss Petitioner's hearing request. |
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JUDGE | |
Steven T. Kessel Administrative Law Judge
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