SUBJECT:

Medical Service Laboratories,

Petitioner,

Centers for Medicare & Medicaid Services

DECISION

Summary judgment is entered affirming the determination of Respondent, the Centers for Medicare & Medicaid Services (CMS) ⁽¹⁾ suspending the CLIA ⁽²⁾ certificate of Petitioner, Medical Service Laboratories, due to a finding of immediate jeopardy. Petitioner's certificate is revoked pursuant to 42 C.F.R. § 493.1844(d)(4)(ii) as I have affirmed the suspension.

By operation of law, Robert L. Gillett, the owner/operator of Petitioner, and Adolfo Boye, M.D., the laboratory director of Petitioner, are prohibited from owning, operating, or directing a laboratory for two years pursuant to 42 U.S.C. § 263a(i)(3) due to the revocation of Petitioner's CLIA certificate. The two-year prohibition runs from the date of the revocation of the laboratory's certificate pursuant to 42 U.S.C. § 263a(i)(3).

The effective date of revocation is the date of my decision affirming the CMS suspension action in this case. 42 C.F.R. § 493.1844(d)(2) and (4)(ii). Summary judgment is appropriate as there are no genuine issues of material fact in dispute and the controlling issues may be resolved as a matter of law.

PROCEDURAL HISTORY

This case is before me pursuant to a request for hearing filed by Petitioner on July 31, 2000, in accordance with 42 C.F.R. § 498.40.

On May 2, 2000, the Texas Department of Health (TDH) initiated a complaint investigation of Petitioner which concluded with its report or statement of deficiencies (SOD) dated May 17, 2000. CMS Exs. 2, 7. ⁽³⁾ TDH reported that eight condition-level deficiencies were found at Petitioner. Based upon the TDH report and Petitioner's compliance history, CMS determined that Petitioner did not meet the requirements to perform testing under CLIA. CMS further declared that the deficiencies found on the May 2000-survey constituted immediate jeopardy to patients served by Petitioner. CMS elected to impose principal sanctions including cancellation of approval to receive Medicare payments effective June 9, 2000; suspension of Petitioner's CLIA certificate effective June 9, 2000; and revocation of Petitioner's CLIA certificate if approved by an ALJ in the event of a timely appeal. Petitioner's laboratory director, Adolfo Boye, M.D., and owner, Robert L. Gillett, were notified of the CMS actions by letter dated June 2, 2000. CMS Ex. 1.

Petitioner filed a request for hearing on July 31, 2000. The case was assigned to Chief Judge Silva on August 30, 2000, for hearing and decision. On November 5, 2001, the case was reassigned to me. Respondent filed its motion for summary judgment and supporting brief on October 25, 2001 (R. Brief). Petitioner filed its response to the Respondent's motion on November 19, 2001 (P. Response). Respondent filed a reply brief on November 28, 2001.

FINDINGS OF FACT

1. On May 2, 2000, Petitioner was certified under CLIA to do a limited range of moderate and high complexity human testing. ⁽⁴⁾ CMS Exs. 2, 7.

2. On May 2 and 3, 2000, the TDH conducted a complaint survey of Petitioner and cited Petitioner for eight condition-level deficiencies. CMS Exs. 2, 7.

3. Robert Gillett was the sole owner and operator of Petitioner before and after the survey of May 2000. CMS Exs. 25, 26.

4. Adolfo Boye, M.D. was the laboratory director of Petitioner before and after the survey of May 2000. CMS Ex. 1.

5. On about April 26, 2000, Petitioner began moderate complexity and high complexity testing of human samples. CMS Ex. 2; Affidavit of Robert Gillett, para. 5.

6. In April 2000, Petitioner made inquiry and completed forms to enroll in proficiency testing to begin in May 2000 for hematology and June 2000 for chemistry. Affidavit of Robert Gillett, ¶ 4.

7. Petitioner never enrolled in proficiency testing. Affidavit of Robert Gillett, ¶ 7.

CONCLUSIONS OF LAW

1. Summary judgment is appropriate as the material facts are not in dispute and this case can be decided as a matter of law.

2. Title 42 C.F.R. § 493.801 establishes the condition-level requirement that a laboratory conducting moderate and high complexity testing must enroll in a proficiency testing program approved by the Secretary.

3. Petitioner began conducting human testing at a moderate and high level of complexity on April 26, 2000, without enrolling in an approved proficiency testing program in violation of 42 C.F.R. § 493.801.

4. The CMS declaration that the condition level violation by Petitioner constituted immediate jeopardy for its patients is not subject to review. 42 C.F.R. § 493.1844(c)(6).

5. Cancellation of approval to receive Medicare payments is mandatory upon suspension of the Petitioner's CLIA certificate. 42 C.F.R. § 493.1842(a)(1).

6. Suspension and revocation of Petitioner's CLIA certificate is supported by the finding of a condition-level deficiency. 42 C.F.R. § 493.1806(a) and (b).

7. The owner and operator of Petitioner is barred from owning, operating, or directing another CLIA certified laboratory for a period of two years by operation of law. 42 U.S.C. § 263a(i)(3).

8. The laboratory director of Petitioner is barred from owning, operating, or directing another CLIA certified laboratory for a period of two years by operation of law. 42 U.S.C. § 263a(i)(3).

9. It is not necessary to review the other alleged deficiencies as the revocation of Petitioner's CLIA certificate is fully supported by the one condition-level deficiency, the existence of which is resolved as a matter of law.

ISSUES PRESENTED

1.a. Whether 42 C.F.R. § 493.801 establishes the condition-level requirement that a laboratory conducting moderate and high complexity testing must enroll in a proficiency testing program approved by the Secretary.

b. Whether Petitioner was in violation of a condition-level requirement for a CLIA certified laboratory.

2. Whether Petitioner's CLIA certificate must be revoked.

3.a. Whether Petitioner's owner/operator is barred from owning, operating or directing another CLIA certified laboratory for two years.

b. Whether Petitioner's laboratory director is barred from owning, operating or directing another CLIA certified laboratory for two years.

GOVERNING LAW

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 is to ensure the accuracy and reliability of laboratory tests, and hence the public health of all Americans. See H.R. Rep. No. 899, 100^th Cong. 2d Sess. 8, 18 (1988), reprinted in 1988 U.S.C.C.A.N. 3828, 3839. CMS certification of a laboratory under CLIA is dependent upon whether the laboratory meets the conditions for certification set out in the statute and regulations. 42 U.S.C. § 263a(f)(1); 42 C.F.R. § 493.1 et seq. Pursuant to CLIA the Secretary of Health and Human Services (Secretary) has broad enforcement authority, including the ability to suspend, limit, or revoke the certificate of a laboratory that is out of compliance with one or more requirements for certification.

The Secretary has exercised his authority under 42 U.S.C. § 263a(f) and issued regulations implementing CLIA. See 42 C.F.R. Part 493. The regulations specify standards and the specific conditions of certification that a laboratory must meet to achieve compliance. The regulations confer broad authority on CMS to ensure that laboratories perform as Congress intended, including authority to inspect and sanction laboratories that fail to comply with the regulatory requirements. CMS has the delegated authority to suspend, limit, or revoke the CLIA certificate of a laboratory that is out of compliance with one or more CLIA conditions, and may also impose alternative sanctions such as a directed plan of correction or monitoring by the state. 42 C.F.R. § 493.1806.

The regulations specify "conditions" and "standards" that laboratories must meet and maintain in order to obtain and retain their CLIA certification and their eligibility to receive Medicare or Medicaid reimbursement. Title 42 C.F.R. § 493.801, the regulatory provisions that is key to this decision provides an example of the regulatory scheme. Section 493.801 includes the condition-level requirement that a laboratory must enroll in a proficiency testing (PT) program and test the PT program specimens in the same manner as it tests patient specimens. Section 493.801 also includes two standard-level requirements that impose additional and more detailed requirements regarding enrollment and testing.

Pursuant to the enforcement provisions, CMS may impose principal or alternative sanctions when it finds that a laboratory has a "condition-level" deficiency. 42 C.F.R. § 493.1804(b)(2). Principal sanctions include suspension, limitation, or revocation of a CLIA certificate. 42 C.F.R. § 493.1806(b). Alternative sanctions include a directed plan of correction, state on-site monitoring, and civil money penalty. 42 C.F.R. § 493.1806(c). Cancellation and or suspension of Medicare payments are also authorized. 42 C.F.R. § 493.1807.

The phrase "immediate jeopardy" is defined at 42 C.F.R. § 493.2 to mean:

(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.

If, on inspection, a laboratory is found to have condition-level deficiencies that pose immediate jeopardy, CMS must require immediate action to remove the jeopardy and may impose alternative sanctions to assist. If the deficiencies remain on revisit, CMS may suspend or limit and later revoke the laboratory's CLIA certificate. CMS is also delegated authority to bring a civil suit for injunction against a laboratory in specified circumstances where there is immediate jeopardy. 42 C.F.R. § 493.1812. Condition-level deficiencies that do not constitute immediate jeopardy and standard-level deficiencies that do not rise to condition level are treated differently and the laboratory is generally accorded 12 months in which to make corrections. 42 C.F.R. §§ 493.1814 - 1816.

Eight condition-level deficiencies are alleged in this case. However, as CMS argues, if on review the existence of even one condition-level deficiency is found, then the CMS suspension of Petitioner's certificate must be upheld. CMS asserts there are no disputed facts as to a violation of 42 C.F.R. § 493.801 and the existence of the violation may be resolved as a matter of law. Title 42 C.F.R. § 493.801 establishes the condition-level requirement that:

Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients'specimens.

If a condition-level violation is found and the laboratories CLIA certificate is revoked, the laboratories owner, operator, and laboratory director are subject to a two-year statutory ban on owning, operating, or directing a laboratory. CLIA provides the following with respect to the owners and operators of non-compliant laboratories in addition to sanctions which may be imposed directly against a laboratory:

(3) Ineligibility to own or operate laboratories after revocation.

No person who has owned or operated a laboratory which has had its certificate revoked may, within 2 years of the revocation of the certificate, own or operate a laboratory for which a certificate has been issued under this section.

42 U.S.C. § 263a(i)(3). This statutory disability arises by operation of law immediately upon revocation of a laboratory's certification. No action by the Secretary is required, no discretion is granted the Secretary, and there is no appeal. The Secretary's regulations specify that a "laboratory director" is considered an "operator" of a laboratory:

Operator means the individual or group of individuals who oversee all facets of the operation of a laboratory and who bear primary responsibility for the safety and reliability of the results of all specimen testing performed in that laboratory. The term includes- (1) A director of the laboratory if he or she meets the stated criteria . . . .

42 C.F.R. § 493.2 (emphasis in original). This definition of "operator" was part of the final regulations that became effective September 1, 1992. The source of the provision that a "laboratory director" is an operator is reflected at 57 Fed. Reg. 7226 (1992) in the discussion of the public comments related to the proposed regulation:

Comment: Four commenters voiced the opinion that if a laboratory's CLIA certificate has been revoked within the preceding two-year period, [CMS] should initiate adverse action, not only against its owner or operator, but also against those directors involved in the operation of the laboratory. Response: We have added a definition of "operator" which clarifies that directors of laboratories who are involved in their overall operation, are knowledgeable about the workings of the entire facility, and who bear primary responsibility for the safety and reliability of laboratory testing, are considered operators for the purpose of this regulation. It is our belief, consistent with the direction given by Congress in section 353(i)(3) of the PHS Act, that any laboratory director who meets the criteria as an operator should not be permitted to operate or own any laboratory within 2 years of operating a laboratory which has had its CLIA certificate revoked, as set forth at § 493.1840(a)(8) of these regulations.

CLIA provides at 42 U.S.C. § 263a(i)(1) that a laboratory's certificate may be suspended, revoked, or limited only after reasonable notice and opportunity for hearing to "the owner or operator of the laboratory. . . ." The Secretary's regulations provide that a laboratory or prospective laboratory dissatisfied with an initial determination listed in 42 C.F.R. § 493.1844(b) is entitled to a hearing before an Administrative Law Judge (ALJ). 42 C.F.R. § 493.1844(a). CMS's decision to suspend, limit, or revoke a laboratory's certificate due to noncompliance with CLIA requirements is an initial determination that is subject to appeal and a hearing by an ALJ. 42 C.F.R. § 494.1844(c)(6). However, the CMS determination that condition-level deficiencies poses immediate jeopardy is not subject to appeal or review. 42 C.F.R. § 493.1844(b)(1). Generally, the suspension, limitation, or revocation of a CLIA certificate is not effective if appealed, until the ALJ makes a decision. However, when CMS declares immediate jeopardy, there is no delay in the suspension or limitation of the offending laboratory's CLIA certificate. 42 C.F.R. § 493.1844(d)(2). If an ALJ upholds a suspension imposed due to immediate jeopardy, that suspension becomes a revocation. 42 C.F.R. § 493.1844(d)(4)(ii).

On ALJ review, CMS bears the burden of producing evidence sufficient to establish a prima facie case. CMS must set forth the basis for its determination with sufficient specificity for a petitioner to respond and come forward with evidence related to the disputed findings. The evidence set forth by CMS must be sufficient to establish a prima facie case that CMS had a legally sufficient basis to impose a remedy. In order for a petitioner to prevail, the petitioner must then prove by a preponderance of the evidence on the record as a whole that it was in substantial compliance with the relevant statutory and regulatory provisions. Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. U.S. Dept. of Health and Human Services, No. 98-3789 (D.N.J. May 13, 1999); Edison Medical Laboratories, Inc., DAB No. 1713 (1999).

Summary judgment is appropriate and no hearing is required where either: there are no disputed issues of material fact and the only questions that must be decided involve application of law to the undisputed facts; or, the moving party must prevail as a matter of law even if all disputed facts are resolved in favor of the party against whom the motion is made. A party opposing summary judgment must allege facts which, if true, would refute the facts relied upon by the moving party. See e.g., Fed. R. Civ. P. 56(c); Garden City Medical Clinic, DAB No. 1763 (2001); Everett Rehabilitation and Medical Center, DAB No. 1628, at 2 (1997) (in-person hearing required where non-movant shows there are material facts in dispute that require testimony); see also, New Millennium CMHC, DAB CR672 (2000); New Life Plus Center, DAB CR700 (2000).

DISCUSSION

1. a. 42 C.F.R. § 493.801 establishes the condition-level requirement that a laboratory conducting moderate and high complexity testing must enroll in a proficiency testing program approved by the Secretary.

CMS alleges that eight condition-level deficiencies were found at Petitioner during the May 2000-survey. However, CMS argues that if the existence of even one condition-level deficiency is found on review, then the CMS suspension of Petitioner's certificate must be upheld. CMS asserts there are no disputed facts as to a violation of 42 C.F.R. § 493.801 and the existence of the violation may be resolved as a matter of law.

Title 42 C.F.R. § 493.801 establishes the condition-level requirement that:

Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens.

b. Petitioner was in violation of a condition-level requirement for a CLIA certified laboratory.

Petitioner's owner/operator has admitted in this case that the Petitioner began testing human samples on April 26, 2000. Affidavit of Robert Gillett, ¶ 5. He further admits that Petitioner made inquires and completed forms for PT programs in hematology and chemistry, but Petitioner did not "fully enroll." Affidavit of Robert Gillett, ¶ 7. Construing Mr. Gillett's statement that Petitioner did not "fully enroll" in a light most favorable to Petitioner, I find that there is only one possible meaning and that is that Petitioner did not complete the enrollment process and as a result it was not enrolled in a PT program at the time of the May 2000-survey. Furthermore, Petitioner makes no allegation and offers no evidence that it remedied the deficiency by enrolling sometime after the May 2000-survey. Petitioner does argue that it made arrangements to participate in PT, but it does not specify what those arrangements were. Petitioner indicates that schedules for PT "were to be consummated by Petitioner during the week beginning May 2, 2000," but it "did not fully enroll" based on the inspection on May 2, 2000. P.

Response, at 3. I take Petitioner's point to be that it planned to enroll in PT, had completed the forms and only needed to send the check, but did not do so because it became apparent that the surveyors were going to shut down the Petitioner. While this may be a reasonable explanation for Petitioner's failure to enroll, I do not find that it satisfies the requirements of the regulation.

Petitioner argues that 42 C.F.R. § 493.801 does not specify that testing can only be performed after enrolling in a PT program. I agree with Petitioner that the regulation does not state the requirement in Petitioner's terms. However, the plan language of the regulation is that "(e)ach laboratory must enroll," which is clearly mandatory language. Further, the second sentence of the regulation requires enrollment in an approved program for each specialty and subspecialty for which the laboratory "seeks certification," which clearly implies that enrollment must be accomplished prior to or at the time of issuance of the CLIA certificate.

Further, it is accepted that the Congressional purpose was to ensure the public health by regulating laboratories to ensure quality. If laboratories are allowed to test and report, without being enrolled and participating in an approved PT program, the Congressional intent would be frustrated as there would be no way to ensure test quality. The Secretary's regulations must be construed consistent with Congressional intent and consistent with fulfilling the Congressional purpose. Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 843 n.9 (1984); Sullivan v. Stoop, 496 U.S. 478, 493 (1990). There is also a history of strict enforcement to achieve the Congressional purpose. Failure by a laboratory to comply with even a single condition in an area of testing offered by that laboratory may be grounds for suspension or revocation of a laboratory's CLIA certificate. Ward General Practice Clinic, DAB No. 1624, at 2 (1997).

Hence, consistent with the plain language of the regulation and Congressional intent, I conclude that the only reasonable interpretation of the regulation is that a laboratory must enroll in the appropriate PT program at certification and before beginning human testing. ⁽⁵⁾

2. Whether Petitioner's CLIA certificate must be revoked.

Petitioner's owner/operator has admitted that Petitioner was not actually enrolled in a PT program when human testing began on April 26, 2002. Petitioner was not enrolled in an approved PT program during the May 2000-survey. Petitioner has made no allegation that it enrolled in an approved PT program at anytime after the survey. I have resolved as a matter of law, that 42 C.F.R. § 493.801 requires a Petitioner to enroll in an approved PT program prior to commencing human testing. Therefore, Petitioner has violated 42 C.F.R. § 493.801 by failing to be enrolled - a condition-level violation. CMS is authorized to suspend or limit a CLIA certificate based upon a condition-level violation.

In this case CMS declared that Petitioner's deficiencies posed immediate jeopardy to its patients. I may not look behind the declaration of immediate jeopardy. However, as there is a basis for suspension in this case and a declaration of immediate jeopardy has been made, suspension with revocation upon issuance of this decision is clearly supported in this case.

3. a. Whether Petitioner's owner/operator is barred from owning, operating or directing another CLIA certified laboratory for two years.

CLIA provides that "no person who has owned or operated a laboratory which has had its certificate revoked may, within 2 years of the revocation of the certificate, own or operate a laboratory for which a certificate has been issued under this section." 42 U.S.C. § 263a(i)(3). This statutory disability arises by operation of law immediately upon revocation of a laboratory's certification. The statute requires no action by the Secretary, no discretion is granted the Secretary, and there is no appeal.

b. Whether Petitioner's laboratory director is barred from owning, operating or directing another CLIA certified laboratory for two years.

Title 42 U.S.C. § 263a(i)(3) applies equally to Petitioner's laboratory director.

Operator means the individual or group of individuals who oversee all facets of the operation of a laboratory and who bear primary responsibility for the safety and reliability of the results of all specimen testing performed in that laboratory. The term includes - (1) A director of the laboratory if he or she meets the stated criteria . . . .

42 C.F.R. § 493.2 (emphasis in original).

Accordingly, both Petitioner's owner/operator, Robert Gillett, and its laboratory director, Adolfo Boye, M.D., are barred from owning, operating or directing a CLIA certified laboratory for a period of two years from the date of this decision.

4. Petitioner's other arguments have no merit.

Petitioner raises several arguments that have no bearing upon the controlling issue and are of no merit. They are mentioned only in the interest of completeness. Petitioner argues that the complaint investigation was invalid. P. Response, at 2. Petitioner's rational is not clear. However, I will not accept an argument in this case challenging the legitimacy of a complaint investigation of a laboratory that has not applied for a certificate, that has not been issued a certificate, that is reportedly testing without a valid certificate, and that is otherwise testing in violation of the law, given the broad enforcement authority Congress granted the Secretary to fulfill the purpose of CLIA.

Petitioner's argument that the survey was unwarranted and unfair and conducted in a harassing and intimidating manner is also without merit. CMS is tasked with conducting enforcement through facility surveys. Whether or not a complaint against a facility has merit may only be determined after a survey is done. A condition of operating is that a laboratory subjects itself to CLIA regulations and enforcement by CMS. Hence, when a complaint is made, a laboratory should expect that a survey will occur and the laboratory has, at least by implication, consented to the survey. I have no doubt that a survey team is intimidating and that laboratory staff may well feel harassed by the mere presence of the team, but the issue is whether either the intimidation or harassment were undue, improper or excessive - allegations which are not present in this case.

Petitioner indicates that the material fact in dispute that prevents entry of summary judgment is that Petitioner "had not been performing patient testing after December 2, 1999, when it was issued a new CLIA certificate." P. Response, at 3. However, I have already discussed that the controlling material facts are that Petitioner admitted beginning testing on April 26, 2000, before enrolling in an approved PT program, and these facts are not in dispute.

Petitioner also argues that CMS violated the settlement agreement it entered into with Petitioner in November 1999, specifically paragraph 8, by conducting a survey without prior arrangement with Petitioner. I have reviewed the settlement agreement at CMS Ex. 27. Paragraph 8 of the agreement states that Petitioner agreed to a compliance survey that would be conducted by CMS no sooner than 60 days after the date of the settlement agreement. Paragraph 8 does not require prior notice by CMS or require further agreement by Petitioner as to the date and time of the compliance survey. Most importantly, paragraph 8 says nothing about complaint surveys and in no way limits CMS's ability to perform its regulatory duty in that regard. Petitioner further argues that CMS violated paragraph 9 of the agreement by not conducting inspections to assist

Petitioner in its compliance with CLIA. Petitioner concludes by stating that "HCFA cannot enforce an agreement that they themselves have broken." Petitioner's argument misses the point that enforcement in this case is not pursuant to any settlement agreement, but is pursuant to the statutory and regulatory enforcement scheme. ⁽⁶⁾

CONCLUSION

For the foregoing reasons, the CMS suspension of Petitioner's CLIA certificate due to a finding of immediate jeopardy is upheld, and the suspension becomes a revocation pursuant to 42 C.F.R. § 493.1844(d)(4)(ii).

Keith W. Sickendick

Administrative Law Judge

1. Effective July 5, 2001, the Health Care Finance Administration was renamed the Centers for Medicare and Medicaid Services (CMS). 66 Fed. Reg. 35437 (2001).

2. Clinical Laboratory Improvement Amendments of 1988, codified at 42 U.S.C. § 263a.

3. The parties completed their final document exchanges on March 15, 2001. Respondent, CMS, submitted 28 proposed exhibits marked "HCFA Ex." Respondent subsequently submitted an amended exhibit list which refers to the exhibits as "CMS." Respondent submitted nine documents with its motion for summary judgment which were originally numbered HCFA Ex. 3; HCFA Ex. 5; HCFA Ex. 6, at 8; HCFA Ex. 6, at 7; HCFA Ex. 4; Exhibit 20 (from Petitioner's final exchanges); HCFA Ex. 27, at 4, 5; Exhibit 19 (from Petitioners' final exchanges); and Exhibit 5 (from Petitioner's final exchanges). Respondent's counsel renumbered all the exhibits attached to the motion for summary judgment designating them in order as Exhibits 1 through 9 with the result that those exhibits now have two exhibit numbers. Renumbering was unnecessary and confusing. Reference to exhibits in this decision is to the exhibit number from Respondent's amended exhibit list filed September 4, 2001 or to Petitioner's list of 26 exhibits filed as part of its final exchanges. CMS exhibits are referred to as "CMS Ex." rather than "HCFA Ex." and Petitioner's exhibits are referred to as "P. Ex.". Petitioner submitted the affidavit of Robert Gillett in support of its brief in opposition to the motion for summary judgment designated as Exhibit A, but it will be referred to as the Affidavit of Robert Gillett.

4. Pursuant to a settlement agreement between Respondent and Petitioner related to an earlier enforcement proceeding, Petitioner was not to do testing involving any atomic absorption procedures, microbiology, or blood banking except ABO typing and RH typing only, for a period of two years. CMS Ex. 27, ¶ 6.

5. The only issues before me relate to whether enrollment in a PT program is required before testing and whether failure to be enrolled violates the regulation. I do not reach the issue that arises when a laboratory is enrolled but participation has not begun.

6. I also note that CMS cannot contract in violation of its regulatory and statutory duties and estoppel will not lie against the government. Office of Personnel Management v. Richmond, 496 U.S. 414 (1990); Heckler v. Community Health Services of Crawford County, Inc, 467 U.S. 51 (1984). While the Supreme Court has not ruled that estoppel will never lie against the government, the decisions in Richmond and Heckler, make clear that estoppel will not lie against the government in cases involving benefits to be paid from the Treasury, particularly in the complicated area of Medicare.