Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of:

Renal CarePartners of Delray Beach,
LLC, (CCN: 10-2854), Date: May 8, 2009
Petitioner,

Docket No. C-09-140
Decision No. CR1950

-V.-

Centers for Medicare & Medicaid
Services.

were SS SH SH SES ES SS SD

DECISION

This matter is before me on the Motions for Summary Judgment filed by the
Centers for Medicare & Medicaid Services (CMS) and by Petitioner Renal
CarePartners of Delray Beach, LLC (Renal CarePartners). CMS and Renal
CarePartners have filed briefs and exhibits in support of their positions. All
proffered exhibits have been admitted. Having reviewed these pleadings and
exhibits, I find that no material facts remain in dispute and conclude that CMS’s
position is correct as a matter of well-recognized and long-established law. I
therefore grant CMS’s Motion and thus summarily affirm CMS’s determination to
approve Renal CarePartners’ provider agreement as an end-stage renal disease
treatment center (ESRD) under the Medicare program effective November 21,
2007, but not earlier. Renal CarePartners’ Motion is in all respects denied.

I. Procedural Background

Renal CarePartners is an ESRD located in Delray Beach, Florida. On or about
April 18, 2007, Renal CarePartners began the process of applying for certification
to participate in the Medicare program by submitting a CMS Form 855A (Form
855A) to the Medicare Part A fiscal intermediary for Florida, First Coast Service
Options (First Coast). By letter dated May 11, 2007, Renal CarePartners informed
the Agency for Health Care Administration (AHCA or state survey agency) that
the facility was fully operational and providing treatment for dialysis patients.
CMS Exhibit (Ex.) 1. Renal CarePartners requested AHCA to visit the facility to
2
perform the initial certification survey. CMS Ex. 1. On July 6, 2007, AHCA
conducted the initial certification survey of Renal CarePartners. P. Ex. A. The
survey revealed no deficiencies, and the survey report stated that Renal
CarePartners “was found in compliance with the requirements for ESRD Facilities
at 42 C.F.R. Part 405.2100, Subpart U.” P. Ex. A. According to Renal
CarePartners, at the exit interview, the state surveyor advised the facility’s staff
that the facility had no deficiencies and they could begin to admit Medicare
patients.

On August 9, 2007, First Coast requested further documentation from Renal
CarePartners to complete its Form 855A review process. P. Ex. B. On August 10,
2007, Renal CarePartners faxed the requested information to First Coast. P. Ex. C.
On September 26, 2007, Renal CarePartners re-faxed the documents it had
submitted to First Coast on August 10, 2007. P. Ex. D. By letter dated November
21, 2007, First Coast advised Renal CarePartners that its Form 855A had been
validated, a recommendation had been made to AHCA, and that AHCA would
determine the next steps in the enrollment process. P. Ex. E.

Renal CarePartners received correspondence from AHCA dated November 29,
2007. In this letter, the state survey agency informed Renal CarePartners that its
Form 855A had been received and was complete, and informed it of the next steps
in the process to be certified to participate in the Medicare program. P. Ex. F.
Renal CarePartners received another letter from AHCA dated February 8, 2008, in
which AHCA formally advised Renal CarePartners that it was found to be in
compliance with the applicable federal regulations during its initial certification
survey of July 6, 2007.’ P. Ex. G. By letter dated March 26, 2008, CMS informed
Renal CarePartners that it met all federal requirements for participation in the
Medicare program effective November 21, 2007. The letter further explained that
the effective date was established in part based on the date First Coast approved
Renal CarePartners’ Form 855A, which was November 21, 2007. P. Ex. H.

On September 22, 2008, Renal CarePartners requested that CMS reconsider its
effective certification date and change the effective date to July 6, 2007. P. Ex. L.

CMS declined to alter the date, and affirmed the November 21, 2007 date in a
letter to Renal CarePartners on October 16, 2008. CMS stated in the letter that the
earliest date CMS could accept that Renal CarePartners met all federal
requirements was the date that First Coast recommended approval for its
enrollment in the Medicare program — November 21, 2007. P. Ex. J.

On December 10, 2008, Renal CarePartners timely filed a request for hearing
contesting CMS’s determination to certify Renal CarePartners eligible to

' AHCA’s letter states that the survey of Renal CarePartners was conducted on
“July 7, 2007.” The date appears to be a typographic error.
3

participate in the Medicare program effective November 21, 2007. As it has
below, Renal CarePartners asserts here the effective date should be July 6, 2007.

II. Issue

The issue before me is simply whether Renal CarePartners is entitled to approval
or certification as a Medicare provider effective as of any date prior to November
21, 2007.

This issue has been addressed in a variety of factual settings by several other
Administrative Law Judges (ALJs), by appellate panels of the Departmental
Appeals Board (Board), and by me most recently in Cedar Park Regional Medical
Center, DAB CR1919 (2009); Dublin Methodist Hospital, DAB CR1894 (2009);
University Behavioral Health of El Paso, LLC, DAB CR1880 (2009); Physicians
Medical Center of Santa Fé, LLC, DAB CR1790 (2008); and Oklahoma Heart
Hospital, DAB CR1719 (2008), aff'd, DAB No. 2183 (2008). Some of those
cases differ slightly from the present one in certain factual details, but all invoke
tules well-settled in this forum, and all rest on principles that require the
conclusion that Renal CarePartners is not entitled to approval or certification as a
Medicare provider on any date prior to November 21, 2007.

III. Controlling Statutes and Regulations

In order to participate in the Medicare program, a prospective provider such as an
ESRD must apply for and be granted an approved provider agreement with CMS.”
The general framework of the application process is set out at section 1866 of the
Social Security Act (Act), 42 U.S.C. § 1395cc. Before CMS will approve a
provider agreement and certify that a prospective provider is eligible, the provider
must meet all of the requirements of participation relevant to that provider. 42
C.F.R. §§ 488.3(a)(2), 489.10(a).

One requirement ESRDs wishing to participate in Medicare must meet addresses
the identity, qualifications, and character of the prospective provider’s operating
entity. The eligibility of the operating entity must be assessed according to the
criteria established at 42 C.F.R. §§ 489.10 and 489.12 for transparency of
ownership, reliability, financial soundness, and compliance with important civil
rights standards. CMS may decline to approve a provider agreement if the

* ESRD facilities are classified as “suppliers,” but it has been held that they are
subject to the application, survey, certification, and enforcement requirements
applicable to “providers.” Maher A. A. Azer (Florence Dialysis Center, Inc.),
DAB CR994 (2003), citing Renal Services Group of El Centro, DAB CR482
(1997); and SRA D/B/A St. Mary Parish Dialysis Center, DAB CR341 (1994).
4

facility’s operating entity does not meet the criteria listed at 42 C.F.R. §§ 489.10
and 489.12.

Another such requirement is that the ESRD’s facility must be surveyed on-site by
an agency authorized by CMS to do so, in order that its compliance with the
requirements of the Medicare program can be assessed and certified. 42 C.F.R.
§§ 489.2(b)(1) and 489.10(a). Either the state agency or the Joint Commission on
Accreditation of Healthcare Organizations (JCAHO) is authorized to conduct
certification surveys. 42 C.F.R. § 488.5. When the surveying agency has
completed its on-site survey, it reports the results and its recommendations to
CMS. 42 C.F.R. § 488.11(a). On the basis of the agency’s report and
recommendations, CMS will determine whether the ESRD’s facility is eligible to
participate in the Medicare program. 42 C.F.R. § 488.12(a)(1).

Generally, the earliest date on which an ESRD may be certified by CMS to
participate in Medicare is established by 42 C.F.R. § 489.13. If an ESRD’s
operating entity has satisfied all other requirements and the survey of that
provider’s facility is the final step in the review sequence, then 42 C.F.R.

§ 489.13(b) controls:

b) All federal requirements are met on the date of the survey. The
agreement or approval is effective on the date the survey . . . is completed,
if on that date the provider or supplier meets all applicable Federal
requirements as set forth in this chapter.

In practice, the survey is usually the last step in the process. But, significantly, 42
C.F.R. § 489.13(c) provides for situations in which the facility survey may be
completed before the operating entity has been approved:

(c) All Federal requirements are not met on the date of survey. If on the
date the survey is completed the provider or supplier fails to meet any of
the requirements specified in paragraph (b) of this section, the following
tules apply:

(2) For an agreement with, or an approval of, any other provider...
the effective date is... :

(i) The date on which the provider or supplier meets all
requirements.
5

Until a facility’s operating entity’s eligibility has been assessed and verified, and
until the facility has been surveyed and certified, its agreement cannot be
approved. Until its agreement has been approved based on those assessments, its
status is that of a prospective provider. 42 C.F.R. § 498.2. With limited
exceptions, none of which are relevant in the matter presently before me, a
prospective provider, such as an ESRD, may not receive reimbursement for
services provided to Medicare beneficiaries prior to the effective date of its
provider agreement. Act, section 1814(a) (42 U.S.C. § 1395f(a)).

IV. Findings of Fact and Conclusions of Law
I find and conclude as follows:

1. Petitioner Renal CarePartners did not meet all applicable federal requirements
for participation in the Medicare program when the AHCA survey of the facility
was completed on July 6, 2007.

2. Petitioner Renal CarePartners did not meet all applicable federal requirements
for participation in the Medicare program at any time between July 6, 2007 and
November 21, 2007.

3. Petitioner Renal CarePartners first met all applicable federal requirements for
participation in the Medicare program on November 21, 2007, when First Coast
approved its Form 855A.

4. Petitioner Renal CarePartners is entitled to approval or certification as a
Medicare provider effective November 21, 2007, but not earlier.

5. There are no disputed issues of material fact and summary disposition is
appropriate in this matter. I have viewed the facts and the inferences reasonably to
be drawn from the facts in the light most favorable to the nonmoving party. See
Pollock v. American Tel. & Tel. Long Lines, 794 F.2d 860, 864 (3rd. Cir. 1986);
Brightview Care Center, DAB No. 2132 (2007); Madison Health Care, Inc., DAB
No. 1927, at 5-7 (2004).

V. Discussion

Although Renal CarePartners attempts to distinguish them, the decisions of this
forum and of the Board that govern its resolution are not in doubt, either as to their
meaning or as to their application in this appeal. They are clear and unambiguous,
and their holdings may be summarized simply: a facility’s application to be a
Medicare provider may not be approved, and CMS may not certify it as a
Medicare provider, until the facility has been determined to meet all applicable
6

federal requirements for participation in the Medicare program, both as to its
facility and as to its operating entity.

There is no dispute as to the material facts surrounding the sequence of steps
leading to CMS’s letter of March 26, 2008. Renal CarePartners applied to
participate in the Medicare program on April 18, 2007, by submitting its Form
855A to First Coast. AHCA completed its survey of Renal CarePartners’ facility
on July 6, 2007, and, based on the survey report, the facility was found to be in
compliance with the Medicare requirements for ESRD facilities. The record
shows that First Coast completed its review of Renal CarePartners’ operating
entity on November 21, 2007, and found the operating entity in compliance with
Medicare requirements. On that date, First Coast wrote to Renal CarePartners,
informing it that its Form 855A had been validated, and that a favorable
recommendation to AHCA had been made. By letter dated February 8, 2008,
AHCA formally advised Renal CarePartners that it was found to be in compliance
with the applicable federal regulations during its initial certification survey of July
6, 2007. Renal CarePartners was subsequently informed by CMS in a letter dated
March 26, 2008, that it met all federal requirements for participation in the
Medicare program effective November 21, 2007, which is the date First Coast
approved the facility’s Form 855A.

It may very well be that the sequence described above is a reversal of the more
commonly-seen sequence in which the facility survey is not undertaken until the
fiscal intermediary has approved the operating entity. Most of the earlier recorded
litigation in this forum seems to have been based on an “entity-approval first,
facility-survey next” model. But that sequence is not the unvarying model, and
four significant exceptions to that model apply to these facts and control the
disposition of this dispute.

The first significant exception to the usual sequence appears in SRA, Inc., D/B/A
St. Mary Parish Dialysis Center, DAB CR341 (1994), a case in which an ESRD
sought certification of its Medicare provider agreement. The ESRD successfully
“passed” a state agency survey of its facility, but certain aspects of the ESRD’s
management, and of its supervisory and professional arrangements, were not then
in compliance with Medicare requirements. Eventually those operating
arrangements were corrected and approved by CMS’s predecessor agency, the
Health Care Financing Administration (HCFA). The ESRD claimed that it was
entitled to certification as of the date of the successful survey, but HCFA insisted
that the ESRD had not met all requirements until its operating arrangements were
7

finally approved. In upholding HCFA’s position, the ALJ announced the rule that
controls this case:

The regulations provide plainly that, where a provider or supplier fails to
meet certification requirements at the date of the inspection, it will be found
to satisfy those requirements either on the date when it actually meets the
requirements or on the date that it submits a plan of correction acceptable to
HCFA, whichever comes first. 42 C.F.R. § 489.13(a) and (b). Thus, a
provider or supplier cannot be certified effective the date of survey where:
(1) deficiencies are found to exist as of the survey date, and (2) the
deficiencies are not corrected (or an acceptable plan of correction is not
submitted by the provider or supplier) until a subsequent date.

SRA, DAB CR341, at 20.

In the three more recent cases to which I have referred briefly above, hospitals had
“passed” a state survey or alternatively, received accreditation by the JCAHO, but
had simply not yet met “all requirements” for certification because their operating
entities had not been approved by the fiscal intermediary. Relying on the rule
enunciated in SRA, I concluded in these cases that the hospitals could not be
certified effective the dates of survey or accreditation as they asked because the
approvals of their operating entities remained unresolved on that date. Cedar Park
Regional Medical Center, DAB CR1919; Dublin Methodist Hospital, DAB
CR1894; Physicians Medical Center of Santa Fé, LLC, DAB CR1790.

There are no exceptions to these rules based on delays in the administrative
process of reviewing a facility’s satisfaction of the participation requirements, and
there are no exceptions based on a facility’s claimed reliance on allegedly-
erroneous representations it complains were made to it by representatives of CMS,
a state agency, or a fiscal intermediary. “The governing regulations are essentially
unforgiving.” Tenet HealthSystem Philadelphia, Inc., DAB CR663, at 7 (2000).

Thus, Renal CarePartners’ claim that it reasonably relied on the surveyor’s
incorrect statement allegedly made at the exit interview concerning the effective
date of its participation in Medicare, and provided ESRD services to Medicare
patients to its detriment, is immaterial. Renal CarePartners’ assertion is based on
the doctrine of equitable estoppel. And equitable estoppel, particularly in cases
involving the effective dates of Medicare provider agreements, is specifically
beyond my authority to consider. Oklahoma Heart Hospital, DAB CR1719, at 10-
11 (2008), aff'd, DAB No. 2183, at 16-17 (2008); Maher A. A. Azer (Florence
Dialysis Center, Inc.), DAB CR994 (2003); Danville HealthCare Surgery Center,
DAB CR892 (2002); Everett Rehabilitation and Medical Center, DAB CR455
(1997), aff'd, DAB No. 1628 (1997).
8

Further, Renal CarePartners’ asserts that First Coast failed to make a
recommendation on its Form 855A within the 30-day time frame as stated in the
State Operations Manual (SOM) and that it suffered a delay of over seven months
before receiving notice of approval of its Form 855A. As I have stated above, any
delay that may occur in the processing of a Form 855A does not entitle the
provider to Medicare privileges. Moreover, without exploring in detail the
provisions of the SOM upon which Renal CarePartners relies, it will suffice to
state that the SOM’s provisions are without the force or effect of law, and may not
be relied on to extend, enlarge, or otherwise alter the plain meaning of applicable
regulations. Beverly Health & Rehabilitation Services, Inc. v. Thompson, 223 F.
Supp. 2d 73, at 99-106 (D.D.C. 2002); Cal Turner Extended Care Pavilion, DAB
No. 2030 (2006); Aase Haugen Homes, Inc., DAB No. 2013, at 15 (2006). I need
not resolve Renal CarePartners’ factual assertions because they raise questions of
fact that have no bearing on the issues I may properly consider. They represent no
bar to summary disposition.

VI. Conclusion

For the reasons discussed above, Renal CarePartners’ Motion for Summary
Judgment is DENIED. CMS’s Motion for Summary Judgment should be, and it
is, GRANTED. | affirm CMS’s determination to certify Renal CarePartners to
participate in the Medicare program as a Medicare provider effective November
21, 2007, but not earlier.

/s/
Richard J. Smith
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: } Date: May 5, 2009

Reginald Maurice Dawson, }
DC # 129868, ) Docket No. C-08-636
) Decision No. CR1949

Petitioner, )

)

- Vv - )

)

The Inspector General. )

)

DECISION

This matter is before me on the Inspector General’s (1.G.’s) Motion for Summary
Affirmance of the L.G.’s determination to exclude Petitioner pro se Reginald Maurice
Dawson from participation in Medicare, Medicaid, and all other federal health care
programs for a period of five years. The I.G.’s Motion and determination to exclude
Petitioner are based on section 1128(a)(4) of the Social Security Act (Act), 42 U.S.C.
§ 1320a-7(a)(4). The facts in this case mandate the five-year exclusion, and for that
reason, I grant the I.G.’s Motion for Summary Affirmance.

I. Background

By letter dated June 30, 2008, the I.G. notified Petitioner that he was being excluded for a
period of five years from participating in the Medicare, Medicaid, and all federal health
care programs. The I.G. informed Petitioner specifically that he was being excluded
pursuant to section 1128(a)(4) of the Act based on his felony conviction in the Circuit
Court, Fourth Judicial Circuit, in and for Duval County, Florida, of a criminal offense
related to the unlawful manufacture, distribution, prescription, or dispensing of a
controlled substance as defined under federal or state law.
By undated letter which was received by the Civil Remedies Division on July 24, 2008,
Petitioner, acting pro se, timely sought review of the I.G.’s action, and the matter was
assigned to me for a hearing and a decision. On August 21, 2008, I held a telephone
prehearing conference with the parties and advised Petitioner of his right to be
represented by an attorney. Petitioner indicated that he wished to proceed pro se. The
1.G. expressed his position that this matter could be resolved on the basis of written
submissions. Petitioner did not explicitly state his position on whether an in-person
hearing was required. | advised the parties that, once I had received their submissions, I
would determine whether an in-person hearing was required. I set a schedule for the
submission of briefs and documentary evidence. See Pre-Hearing Order, dated
September 2, 2008 (Order).

The I.G. has submitted a brief with nine proposed exhibits attached (I.G. Exs. 1-9).
Because I did not receive a response brief from Petitioner, I issued an Order to Show
Cause, directing Petitioner to show cause why I should not dismiss his request for hearing
or abandonment or dismiss as a sanction. Petitioner filed a response to the Order to
Show Cause out of time, requesting an opportunity to respond to the I.G.’s position. I
was persuaded by Petitioner’s explanation for his untimely submission, and accepted his
response. I gave Petitioner an opportunity to respond to the I.G.’s brief, and revised the
briefing schedule. See Order Establishing A Revised Briefing Schedule, dated February
4, 2009.

Petitioner submitted a response, with no proposed exhibits. The 1G. did not file a reply
brief. Petitioner has expressed no objection to the I.G.’s proposed exhibits, and so I
admit into evidence I.G. Exs. 1-9.

II. Issue

The sole issue before me is whether the I.G. had a basis for excluding Petitioner from
participation in the Medicare, Medicaid, and all federal health care programs. Because an
exclusion under section 1128(a)(4) of the Act must be for a minimum period of five
years, the reasonableness of the length of the exclusion is not an issue.

Ill. Controlling Statutes and Regulations

Section 1128(a)(4) of the Act, 42 U.S.C. § 1320a-7(a)(4), requires the mandatory
exclusion from participation in Medicare, Medicaid, and all other federal health care
programs of “[a]ny individual or entity that has been convicted for an offense which
occurred . . . [after August 21, 1996] . . . under Federal or State law, of a criminal offense
consisting of a felony relating to the unlawful manufacture, distribution, prescription, or
dispensing of a controlled substance.” The terms of section 1128(a)(4) are restated
somewhat more broadly in regulatory language at 42 C.F.R. § 1001.101(d).
The Act defines “convicted” as including those circumstances: “(1) when a judgment of
conviction has been entered against the individual... by a... State. . . court, regardless
of whether . . . the judgment of conviction or other record relating to criminal conduct has
been expunged;” or “(2) when there has been a finding of guilt against the individual . . .
bya... State... court;” or “(3) when a plea of guilty or nolo contendere by the
individual . . . has been accepted by a... State... court....” Act, section 1128(i)(1)-
(3), 42 U.S.C. § 1320a-7(i)(1)-(3). These definitions are repeated at 42 C.F.R. § 1001.2.

An exclusion based on section 1128(a)(4) of the Act is mandatory, and the I.G. must
impose it for a minimum period of five years. Act, section 1128(c)(3)(B), 42 U.S.C.
§ 1320a-7(c)(3)(B). The regulatory language of 42 C.F.R. § 1001.102(a) affirms the
statutory provision.

IV. Discussion

A, Petitioner was convicted of a felony relating to the unlawful manufacture,
distribution, prescription, or dispensing of a controlled substance, within the
meaning of section 1128(a)(4) of the Act.'

Section 1128(a)(4) of the Act requires that any individual or entity convicted of a felony
criminal offense that occurred after the date of the enactment of the Health Insurance
Portability and Accountability Act (August 21, 1996) “relating to the unlawful
manufacture, distribution, prescription, or dispensing of a controlled substance” be
excluded from all federal health care programs.’

During the time period relevant to this case, Petitioner was a licensed pharmacist in the
State of Florida. Petitioner operated a pharmacy called “Your Family Pharmacy” located
in Jacksonville, Florida. On February 26, 2007, an eight-count criminal information was
filed against Petitioner and three others in the Circuit Court of the Fourth Judicial Circuit
in and for Duval County, Florida. 1.G. Ex. 7. The information charged Petitioner
specifically, at Counts 1, 2, 3, and 7, with violation of racketeering laws, conspiracy to

' My findings of fact and conclusions of law are set forth, in italics and bold, in the
discussion captions of this decision.

> “Federal health care program” is defined in section 1128B(f) of the Act as any plan or
program that provides health benefits, whether directly, through insurance, or otherwise,
which is funded directly, in whole or in part, by the United States Government, or any
State health care program.
traffic in controlled substances, and Medicaid provider fraud. Specifically, Counts 2 and
3 alleged that Petitioner, “on or between February 1, 2005 and January 24, 2006, in the
County of Duval and the State of Florida, did agree, conspire, combine or confederate
with [other named co-defendants] to knowingly sell, purchase, manufacture, deliver,
bring into the State, or to be knowingly in actual or constructive possession of”
Oxycodone and Hydrocodone, “contrary to the provisions of Sections 893.135(5) and
777.04(3), Florida Statutes.” I.G. Ex. 7, at 1. Count 7, which was related to Medicaid
provider fraud, alleged that Petitioner, “on or between February 1, 2005 and January 24,
2006, in the County of Duval and the State of Florida, did knowingly make, cause to be
made or aid and abet in the making of a claim for items or services that are not authorized
to be reimbursed by the medicaid program, . . . contrary to the provisions of Section
409.920(2)(b), Florida Statutes.” I.G. Ex. 7, at 2.

Petitioner appeared with counsel in the Circuit Court of the Fourth Judicial Circuit, in and
for Duval County, Florida, on November 30, 2007, and pleaded guilty to Count 2 of the
information, “Conspiracy to Traffic in Controlled Substances,” a felony in violation of
FLA. STAT. ANN §§ 893.135(5) and 777.04(3). 1G. Ex. 8. The court accepted
Petitioner’s guilty plea, found him guilty, and entered judgment of conviction on January
7, 2008. I.G. Ex .2.' On that day, pursuant to the terms of a negotiated sentence, the
court sentenced Petitioner to 24 months in prison, and ordered him to pay court costs of
$441, and restitution in the amount of $21,811.14 to the Agency for Health Care
Administration, which amount was to be owed jointly and severally with a co-defendant.
1G. Ex. 2; see I.G. Ex. 8. As part of the sentence, Petitioner permanently surrendered his
Florida Department of Health pharmacy license. I.G. Ex. 2; see I.G. Ex. 8. Counts 1, 3,
and 7 were dismissed nolle prosequi.

Petitioner does not dispute that he has been convicted of a felony, and the fact of his
conviction is conclusively established by the court records. The court’s acceptance of his
guilty plea, finding of guilt, and the entry of a judgment of conviction, constitute a
“conviction” within the meaning of sections 1128(i)(1), 1128(i)(2), and 1128(i)(3) of the
Act, and 42 C.F.R. § 1001.2.

Petitioner’s felony conviction for Conspiracy to Traffic in Controlled Substances, is, on
its face, related to the unlawful manufacture, distribution, prescription, or dispensing of a
controlled substance. There is no doubt that the criminal conduct described in Count 2
and to which Petitioner pleaded guilty — conspiring with others to “knowingly sell,
purchase, manufacture, deliver, bring into the State, or to be knowingly in actual or

' Petitioner states that he is currently appealing his conviction to the “district court
of appeals.” I.G. Ex. 3. Petitioner’s appeal of his criminal conviction is irrelevant to my
decision here.
constructive possession of Oxycodone” plainly related to the unlawful manufacture,
distribution, prescription, or dispensing of a controlled substance. The requisite
connection to controlled substances is thus established, and there can be no dispute that
Petitioner committed a crime that falls squarely within the purview of section 1128(a)(4)
of the Act.

In his defense, Petitioner asserts that he “operated [his] Pharmacy never with the intent of
defrauding the government in any way” and was not guilty of committing any crimes.
Petitioner’s hearing request at 1; I.G. Exs. 3, 4; see Petitioner’s Response. Petitioner
contends that other pharmacists engaged in filling fraudulent prescriptions, but were
never prosecuted. In Petitioner’s view, he was “selectively prosecuted” and “selectively
excluded from the Federal Health Care process.” Petitioner’s hearing request at 1; I.G.
Ex. 4. Petitioner argues that the fact that he has not practiced pharmacy for over three
years should be disbarment enough, and wonders how he can be perceived as a “threat to
the integrity of the system” if he’s no longer a practicing pharmacist. Petitioner’s
Response at 2.

Insofar as Petitioner himself now seeks to minimize or dilute his admission of
criminality, he is bound by his guilty plea to Count 2 of the Information. Any form of
collateral attack on predicate convictions in exclusion proceedings is precluded by
regulation at 42 C.F.R. § 1001.2007(d), and that preclusion has been affirmed repeatedly
by the Departmental Appeals Board. Susan Malady, R.N., DAB No. 1816 (2002); Dr.
Frank R. Pennington, M.D., DAB No. 1786 (2001); Joann Fletcher Cash, DAB No. 1725
(2000); Paul R. Scollo, D.P.M., DAB No. 1498 (1994); Chander Kachoria, R.Ph., DAB
No. 1380 (1993).

Petitioner appears here pro se, and for this reason, I have taken additional care in reading
his submissions. In doing so, I have been guided by the Board’s reminders that pro se
litigants should be offered “some extra measure of consideration” in developing their
records and their cases. Louis Mathews, DAB No. 1574 (1996); Edward J. Petrus, Jr.,
M.D., et al., DAB No. 1264 (1991). I have searched for any arguments or contentions
that might raise a valid defense to the proposed exclusion. I have found nothing that
could be so construed.

Resolution of a case by summary disposition is particularly fitting when settled law can
be applied to undisputed material facts. Michael J. Rosen, M.D., DAB No. 2096; Thelma
Walley, DAB No. 1367. Summary disposition is authorized by the terms of 42 C.F.R.

§ 1005.4(b)(12). This forum looks to FED. R. CIV. P. 56 for guidance in applying that
regulation. Robert C. Greenwood, DAB No. 1423 (1993). The material facts in this case
are undisputed and unambiguous. They support summary disposition as a matter of
settled law. This Decision issues accordingly.

B. Pursuant to section 1128(c)(3)(B) of the Act, the minimum period of
exclusion under section 1128(a)(4) is five years.

An exclusion under section 1128(a)(4) of the Act must be for a minimum mandatory
period of five years. As set forth in section 1128(c)(3)(B) of the Act:

Subject to subparagraph (G), in the case of an exclusion under subsection
(a), the minimum period of exclusion shall be not less than five years ....

When the I.G. imposes an exclusion for the mandatory five-year period, the
reasonableness of the length of the exclusion is not an issue. 42 C.F.R.

§ 1001.2007(a)(2). Petitioner was convicted of a felony relating to the unlawful
manufacture, distribution, prescription, or dispensing of a controlled substance. As a
result of Petitioner’s conviction, the I.G. was required to exclude him pursuant to section
1128(a)(4) of the Act, for at least five years.

V. Conclusion

For these reasons, I conclude that the I.G. properly excluded Petitioner from participation
in Medicare, Medicaid, and all other federal health care programs, and I sustain the five-
year exclusion.

/s/
Alfonso J. Montano
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
)
Keith Howard Roberts, ) Date: May 5, 2009
)
Petitioner, ) Docket No. C-09-146
) Decision No. CR1948
v. )
)
The Inspector General. )
)
DECISION

Petitioner, Keith Howard Roberts, is excluded from participation in Medicare, Medicaid,
and all other federal health care programs pursuant to section 1128(b)(4) of the Social
Security Act (Act) (42 U.S.C. § 1320a-7(b)(4)), effective October 20, 2008. Petitioner is
excluded because his license to provide health care as a professional counselor in the
State of Ohio was revoked by the Ohio Counselor, Social Worker & Marriage and Family
Therapist Board (The Ohio Board), for reasons bearing upon his professional
competence, professional performance, or financial integrity. There is a proper basis for
exclusion. Petitioner’s exclusion for not less than the period during which his state
license is revoked, is required by the Act.' Act, § 1128(c)(3)(E) (42 U.S.C. § 1320a-

T(c)(3)(E)).
I. Background

The Inspector General for the Department of Health and Human Services (1.G.) notified
Petitioner by letter dated September 30, 2008, that he was being excluded from
participation in Medicare, Medicaid, and all federal health care programs pursuant to
section 1128(b)(4) of the Act, until he regains his license as a counselor in the State of
Ohio. Petitioner requested a hearing by an undated “Notice of Appeal” received at the

' Pursuant to 42 C.F.R. § 1001.3001, Petitioner may apply for reinstatement only
after the period of exclusion expires. Reinstatement is not automatic upon completion of
the period of exclusion.
Departmental Appeals Board on December 12, 2008. The LG. has not asserted that the
request for hearing was untimely. The case was assigned to me for hearing and decision.
On January 5, 2009, I convened a prehearing telephonic conference, the substance of
which is memorialized in my Order dated January 6, 2009. The parties agreed that the
case could be decided based on briefs and documentary evidence, and Petitioner waived
the right to an in-person hearing.

The LG. filed a brief in support of exclusion on February 4, 2009 (I.G. Brief), with I.G.
Exhibits (1.G. Exs.) 1 and 2. Petitioner filed a response (P. Brief) on April 6, 2009.
Petitioner did not file any exhibits. The I.G. filed a reply (I.G. Reply) on April 24, 2009,
with I.G. Ex. 3. No objection has been made to my consideration of I.G. Exs. 1 and 2 and
both are admitted. I.G. Ex. 3 is not admitted because it is not relevant.’

II. Discussion

A. Issues

The Secretary of Health and Human Services (the Secretary) has by regulation limited my
scope of review to two issues:

Whether there is a basis for the imposition of the exclusion; and,

Whether the length of the exclusion is unreasonable.
42 CFR. § 1001.2007(a)(1).

B. Applicable Law
Petitioner’s right to a hearing by an administrative law judge (ALJ) and judicial review of
the final action of the Secretary is provided by section 1128(f) of the Act (42 U.S.C.

§ 1320a-7(f)). Petitioner’s request for a hearing was timely filed and I do have
jurisdiction.

> 1G. Ex. 3 is a clinical evaluation of Petitioner prepared in 2004 related to an
application to become a Licensed Professional Clinical Counselor. Although it is listed as
a state exhibit in The Ohio Board’s Adjudication Order (I.G. Ex. 2, at 2), the order does
not indicate whether the evaluation impacted the decision to revoke Petitioner’s license.
Because the evaluation was completed in 2004, it does not provide any information
regarding Petitioner’s professional competence or performance in 2007 when his license
was revoked.
Pursuant to section 1128(b)(4)(A) of the Act, the Secretary may exclude from
participation in Medicare, Medicaid, and all federal health care programs, any individual
whose license to provide health care is revoked or suspended by any state licensing
authority for reasons bearing upon the individual’s professional competence, professional
performance, or financial integrity. See also 42 C.F.R. § 1001.501(a)(1). The standard of
proof is a preponderance of the evidence and the state agency determination revoking
Petitioner’s state license is not subject to my review. 42 C.F.R. § 1001.2007(c) and (d).
Petitioner bears the burden of proof and persuasion on any affirmative defenses or
mitigating factors and the I.G. bears the burden on all other issues. 42 C.F.R.

§ 1005.15(b) and (c).

C. Analysis
My conclusions of law are in bold followed by my findings of fact and analysis.

1. There is a basis for Petitioner’s exclusion pursuant to section
1128(b)(4)(A) of the Act.

The LG. cites section 1128(b)(4) of the Act as the basis for Petitioner’s permissive
exclusion. I.G. Ex. 1. The statute provides:

(b) PERMISSIVE EXCLUSION. - The Secretary may
exclude the following individuals and entities from
participation in any Federal health care program (as defined in
section 1128B(f)):

ek KK
(4) LICENSE REVOCATION OR SUSPENSION. - ANY
INDIVIDUAL OR ENTITY -

(A) whose license to provide health care has
been revoked or suspended by any State
licensing authority, or who otherwise lost such a
license or the right to apply for or renew such a
license, for reasons bearing on the individual’s
or entity’s professional competence,
professional performance, or financial integrity,

The statute permits the Secretary to exclude from participation any individual: (1) whose
state license to provide health care has been suspended or revoked by a state licensing
authority; and (2) the revocation or suspension is for reasons bearing on the individual’s
professional competence, professional performance, or financial integrity.
Petitioner does not dispute that his license to practice counseling was revoked by The
Ohio Board on January 19, 2007. P. Brief at 2. Petitioner does not deny or rebut the
1.G.’s evidence that shows The Ohio Board revoked Petitioner’s professional counselor
license based on findings that Petitioner was “impaired and unable to practice to the
standards expected of a licensed professional counselor.” I.G. Ex. 2, at 3. The Ohio
Board based its decision on evidence that Petitioner had a history of substance abuse, and
that he had recently relapsed into active substance abuse, which impaired his ability to
perform properly as a professional counselor. The Ohio Board’s decision indicates it
considered a complaint against Petitioner from his employer due to Petitioner’s erratic
and irresponsible work behavior and his admission, when pressed for a drug and alcohol
screen, that he had indeed relapsed. The Ohio Board also considered Petitioner’s March
9, 2006 letter to The Ohio Board in which he admitted that he had another relapse into
active substance abuse in January 2006, he resigned his counseling jobs on February 9,
2006, and he sought treatment beginning February 14, 2006. I.G. Ex. 2, at 2-3, 17-18, 20.
Prior to issuing its Order, the Board provided Petitioner with several notices of the
Board’s proposed action as well as an opportunity for a hearing. I. G. Ex. 2 at 6-11, 15,
16. Petitioner did not request a hearing before The Ohio Board. I.G. Ex. 2, at 2.3

Petitioner argues before me that the I.G. has no authority or jurisdiction to exclude him
pursuant to section 1128(b)(4) of the Act because, as a counselor, he was not a “health
care provider.” P. Brief at 2-3. Petitioner also argues that the I.G. cannot show that his
counselor’s license was revoked for reasons bearing upon his professional competence or
performance or his financial integrity. P. Brief at 3. Neither argument has any merit.

Section 1128(b)(4)(A) of the Act permits the Secretary to exclude “individuals and
entities” “whose license to provide health care” has been suspended or revoked by a state
icensing authority. Contrary to Petitioner’s argument, the plain language of the section
does not limit the Secretary to excluding only those who meet the definition of “health
care provider.” Petitioner does not dispute that he had a license to practice as a licensed
professional counselor in Ohio as required by Ohio Rev. Code Ann. § 4757.23. He does
not dispute that his counselor’s license was revoked by The Ohio Board — the state
agency responsible for the regulation of counselors, social workers and marriage and
family therapists in the State of Ohio. LG. Ex. 2; P. Brief at 2; Ohio Rev. Code Ann.

§§ 4757.05, 4757.36.

> Petitioner stated in his request for hearing (RFH) that he appealed the decision of
The Ohio Board to the Mahoning County Common Pleas Court and the appeal was
pending. RFH at 2. Petitioner does not indicate in his brief whether the appeal was still
pending. However, if his appeal is successful, the regulations require that he be reinstated
in Medicare, Medicaid, and other federal health care programs retroactive to the effective
date of the exclusion. 42 C.F.R. § 1001.3005.
I conclude, based upon the applicable Ohio law, that Petitioner’s professional counselor
license authorized him to provide health care. Pursuant to Ohio Rev. Code Ann.

§ 4757.01(A), the “‘[p]ractice of professional counseling’ means rendering or offering to
render to individuals, groups, organizations, or the general public a counseling service
involving the application of clinical counseling principles, methods, or procedures to
assist individuals in achieving more effective personal, social, educational, or career
development and adjustment, including the diagnosis and treatment of mental and
emotional disorders.” “Clinical counseling principles, methods, or procedures’ means an
approach to counseling that emphasizes the counselor’s role in systematically assisting
clients through all of the following: assessing and analyzing background and current
information, diagnosing mental and emotional disorders, exploring possible solutions, and
developing and providing a treatment plan for mental and emotional adjustment or
development. ‘Clinical counseling principles, methods or procedures’ includes at least
counseling, appraisal, consulting and referral.” Ohio Rev. Code Ann. § 4757.01(B). A
licensed professional counselor in Ohio is permitted to diagnose and treat mental and
emotional disorders under supervision of a psychologist, psychiatrist, professional clinical
counselor, independent marriage and family therapist, or independent social worker.

Ohio Rev. Code Ann. § 4757.21. Petitioner was licensed as a professional counselor
under the Ohio law. The foregoing sections of the Ohio law clearly show that Petitioner
was authorized by his license to “provide health care” within the meaning of section
1128(b)(4) of the Act. I further conclude, contrary to Petitioner’s argument, that he was a
“health care provider” within the meaning of section 1171(3) of the Act (42 U.S.C.

§ 1320d(3)), because he fit within the catch-all provision of the definition, i.e., “any other
person furnishing health care services or supplies.”

Petitioner’s second argument is also without merit because The Ohio Board’s decision
clearly shows that his license was revoked for reasons bearing upon his professional
competence and performance. The Act permits the LG. to exclude an individual whose
license has been revoked by a state licensing agency, such as the state agency here, where
the reason for the revocation or suspension bore on the individuals’s professional
competence, performance, or financial integrity. The Ohio Board revoked Petitioner’s
license as a professional counselor based on the finding that Petitioner was “impaired”
due to substance abuse and was “unable to practice to the standards expected of a licensed
professional counselor.” I.G. Ex. 2, at 3. The Ohio Board’s choice of language clearly
reflects a nexus between his relapse into substance abuse and the Board’s conclusion that
he could not meet the standards of professional competence and performance The Ohio
Board expected of a licensed professional counselor.

I conclude that the evidence shows that Petitioner’s professional counselor’s license was
revoked and that the revocation was for reasons related to Petitioner’s professional
competence and performance. Accordingly, there is a basis for Petitioner’s exclusion
from Medicare, Medicaid, and all federal health care programs pursuant to section
1128(b)(4) of the Act.
2. The period of exclusion is reasonable as a matter of law.

There is no issue regarding the duration of the exclusion, as section 1128(c)(3)(E) of the
Act specifies that the exclusion shall not be less than the period during which Petitioner’s
state license to provide health care is revoked, suspended, or surrendered. See also 42
C.F.R. § 1001.501(b)(1). The Secretary’s regulations provide that the LG. will consider a
request for reinstatement only after the individual obtains a valid license in the state
where the individual’s license was originally suspended or revoked. 42 C.F.R.

§ 1001.501(b)(4).

Petitioner argues in his request for hearing that if he had been excluded pursuant to
section 1128(a) of the Act for commission of a crime, he could have been excluded for as
few as five years rather than what amounts to a lifetime exclusion under section
1128(b)(4) of the Act. RFH at 2. Congress specified that the period of exclusion under
section 1128(b)(4) would be not less than the period during which the state license was
revoked or suspended. Act, § 1128(c)(3)(E). The Secretary, the I.G. and I are bound by
the statute.

III. Conclusion

For the foregoing reasons, Petitioner is excluded from participation in Medicare,
Medicaid, and all federal health care programs effective October 20, 2008, 20 days after
the September 30, 2008 I.G. notice of exclusion, and for a period coterminous with his
license revocation.

/s/
Keith W. Sickendick
Administrative Law Judge


The Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

The Centers for Medicare & Medicaid
Services.

In the case of: )
)
InterCare Community Health ) Date: May 5, 2009
Network Inc. (CCN: 23-1929), )
)
Petitioner, ) Docket No. C-09-68
) Decision No. CR1947
-V.- )
)
)
)
)

DECISION GRANTING SUMMARY DISPOSITION
TO CENTER FOR MEDICARE & MEDICAID SERVICES

I grant summary disposition to the Centers for Medicare & Medicaid Services (CMS)
sustaining its determination to establish May 19, 2008 as the effective date for
participation in the Medicare program of Petitioner, InterCare Community Health
Network, Inc. I deny Petitioner’s cross motion for summary disposition.

I. Background

On March 25, 2008 Petitioner applied to participate in the Medicare program as a
Federally Qualified Health Center (FQHC). CMS determined to accept Petitioner’s
application and to enroll Petitioner in the program effective May 19, 2008. Petitioner
sought reconsideration of this determination, arguing that its application should have
been accepted by CMS effective April 1, 2008. On reconsideration CMS affirmed its
initial determination. Petitioner requested a hearing and the case was assigned to me for
a hearing and a decision. CMS moved for summary disposition. Petitioner opposed the
motion and cross moved for summary disposition. CMS filed a brief in opposition to
Petitioner’s cross motion.
2

CMS submitted eight proposed exhibits, which it designated as CMS Ex. 1 — CMS Ex. 8,
in support of its motion for summary disposition. Petitioner submitted a single exhibit,
which it designated as P. Ex. A, in opposition to CMS’s motion and in support of its cross
motion for summary disposition. CMS then submitted four additional exhibits, which it
identified as CMS Ex. 9- CMS Ex. 12, in response to Petitioner’s cross motion for
summary disposition. I receive all of these exhibits into the record of this case and I cite
to some of them in the body of this decision. I note, however, that there are no disputed
material facts in this case and I make no evidentiary findings based on the parties’
exhibits.

IL. Issue, findings of fact and conclusions of law
A. Issue

The issue in this case is whether May 19, 2008 is the effective date of Petitioner’s
enrollment in the Medicare program.

B. Findings of fact and conclusions of law

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 separate heading.

1. An FQHC may not be enrolled as a Medicare participant until CMS
accepts a signed agreement from the FQHC which assures that it meets
all participation requirements.

There are basic criteria which every applicant for participation in Medicare must satisfy
as a prerequisite to enrollment. First, the applicant must satisfy all Medicare participation
requirements. In order to satisfy these requirements an applicant must, among other
things, complete an enrollment application and supply all of the information required of it
by 42 C.F.R. § 424.510(d)(2). Second, CMS must accept a signed agreement from the
applicant which assures that all federal participation requirements are met. 42 C.F.R.

§ 405.2434(b)(1); see 42 C.F.R. § 489.13(a)(2).

Completion of an application for enrollment is not by law synonymous with acceptance.
Enrollment cannot occur until CMS formally accepts a signed agreement from an
applicant. An applicant may not be deemed to have been enrolled at a date that is earlier
than the acceptance date. The regulations contemplate that CMS or an entity or entities
that it designates to act on its behalf will review for completeness and accuracy any
application before accepting it. Nothing in the regulations mandates that CMS accept an
3

application on the date that it is filed even if that application is subsequently determined
to be complete on that date. Thus, the regulations contemplate that there may be a time

lag between the date when an applicant files for enrollment and the date when review of
the application is completed.

2. CMS reasonably determined to accept Petitioner’s application for
enrollment effective May 19, 2008.

These facts are undisputed. On April 10, 2008, National Government Services (NGS), a
Medicare intermediary acting on behalf of CMS, received an application from Petitioner
to enroll as an FQHC. CMS Ex. 2, at 5. The application was made on a form known as a
“CMS 855A”. Id. The enrollment application contained an attestation statement signed
on behalf of Petitioner on April 8, 2008 which attested specifically that Petitioner was in
compliance with federal requirements governing FQHCs. CMS Ex. 4, at 3. The form
was not complete and on subsequent dates Petitioner provided NGS with additional
information that was necessary to complete its application for enrollment. For example,
the application lacked necessary information concerning Petitioner’s Public Health
Service Grant. It also was missing identifying information concerning a member of
Petitioner’s management. Petitioner submitted additional relevant information on April
24, April 30, May 2, and May 6, 2008. CMS Ex. 2, at 8, 22, 37, 39, 45-57, 64, 68, 69, 71,
72.

On May 19, 2008 NGS forwarded to CMS the completed enrollment application.
However, NGS erroneously sent the application to the wrong regional office. It rectified
that error on June 11, 2008 when it forwarded the completed enrollment application to
CMS’s Chicago regional office. CMS Ex. 2, at 1-2; CMS Ex. 3. In forwarding the
application NGS advised CMS that it had reviewed it and that it had found no evidence
that the application should be denied. CMS Ex. 2, at 2; CMS Ex. 3, at 2. On June 18,
2008, CMS notified Petitioner that its request for enrollment as an FQHC had been
approved with an effective date of participation of May 19, 2008. CMS Ex. 4. CMS did
not penalize Petitioner for the delay caused by NGS’s erroneous forwarding of
Petitioner’s application to the wrong office. CMS accepted the application effective the
date when NGS completed its review.

The gravamen of Petitioner’s argument that it should be enrolled effective April 1, 2008
is that it should not be held hostage to the administrative review process. Petitioner
argues that it acted in good faith to provide expeditiously to NGS all of the information
that NGS demanded of it. It asserts that, if there were delays in the review process, none
of them were its fault and it should not be penalized for those delays. For example,
Petitioner asserts that it had completed and submitted an initial application for

4

participation on March 25, 2008. Petitioner’s opposition to CMS’s motion for summary
disposition and cross motion for summary disposition (Petitioner’s brief) at 2. It asserts
that it had to resubmit its application because of faulty advice that it received from NGS.
Id.

Petitioner does not contend that it actually satisfied all regulatory requirements for
enrollment as of April 1, 2008. It concedes that it had not provided NGS or CMS with all
that was necessary to qualify as an FQHC by that date. In fact, the chronology of events
supplied by Petitioner corroborates that it did not supply NGS with all necessary
information until a date subsequent to April 1. P. Ex. A, at 2.

That Petitioner may have experienced some delays in providing NGS with all necessary
information — even if those delays may have been caused by errors committed by NGS —
is no basis for me to order Petitioner to be enrolled on a date that is earlier than the date
when NGS completed its review of the application and found that Petitioner met all
participation requirements. The regulatory criteria for enrollment allow no such
exception to the rule governing when enrollment will be made effective. Even assuming
all of Petitioner’s complaints and assertions to be true there is nothing in the regulations
which requires CMS to accept an application for enrollment on a date that is earlier than
the date when the application is complete and when CMS or the entity delegated to act on
its behalf have completed a review of the application.

Petitioner relies on a decision by the Departmental Appeals Board in Family Health
Services of Darke County, DAB No. 2092 (2007) to support its argument that it should
have been enrolled effective April 1, 2008. In fact, there is nothing in the Darke County
decision that supports Petitioner’s argument.

In Darke County a Board appellate panel remanded an administrative law judge decision
with instructions that the judge decide whether CMS may have “accepted” applications
for participation by two FQHCs over the course of more than two years of dealing with
these entities in which CMS arguably acted as if they had been enrolled. The Board
panel was particularly concerned with the possibility that the entities had supplied CMS
with all of the information necessary to qualify as an FQHC even if they had not filled
out and filed a formal application for FQHC participation. The Board panel remanded
the case so that the administrative law judge could decide whether CMS had
constructively accepted the applications at a date or dates prior to the date when CMS
formally accepted them.

Darke County was predicated on the possibility that CMS received all that it needed to
accept applications for FQHC and constructively accepted that information — as
demonstrated by a possible course of dealing with the applicants — even if the applicants
failed to fill out the requisite forms. Here, however, there is no argument that CMS
received all of the requisite information and constructively accepted it at some date
5

earlier than May 19, 2008. Petitioner is arguing that CMS should be made to accept its
application as of April 1, 2008 even if Petitioner had not supplied NGS or CMS with all
necessary information and attestations by that date. That is an argument that is not
addressed by the Darke County decision and, indeed, there is nothing in that decision that
suggests that a Board appellate panel would agree with Petitioner’s argument.

At bottom, Petitioner’s argument rests on equitable considerations. It contends,
essentially, that it is the victim of errors that it did not make or which were induced by
the actions of others. Had the process worked optimally, according to Petitioner, it would
have been enrolled by April 1, 2008. However, I have no authority to address
considerations of equity. The regulations are unequivocal. An applicant for FQHC
enrollment may not be enrolled until it provides all requisite information and assurances
to CMS or to the entity that CMS designates to act on its behalf and CMS determines to
accept the application as complete. In this case, acceptance did not occur until May 19,
2008 and that is the effective date of Petitioner’s enrollment.

/s/
Steven T. Kessel
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of:

Sky Medical Services,
(Supplier No. 5816230001),

Date: May 4, 2009

Petitioner,

Docket No. C-09-107
Decision No. CR1946

-V.-

Centers for Medicare & Medicaid
Services.

wr SSS SS ES SS SS DY

DECISION
1 affirm the revocation of Sky Medical Services’ supplier number.
I. Background

Petitioner, Sky Medical Services, was enrolled in the Medicare program as a supplier of
durable medical equipment, prosthetics, orthotics and supplies (DMEPOS), effective
January 9, 2008. On May 15, 2008, the Supplier Audit and Compliance Unit, National
Supplier Clearinghouse, Palmetto GBA (NSC), a CMS contractor,’ sent a letter to
Petitioner stating that its supplier number would be revoked 15 days from the postmark of
the letter. CMS Ex. 2, at 58-59.” Petitioner was informed that the basis for the
revocation was its failure to be operational or open on more than one occasion when an

' NSC, a division of Palmetto GBA, LLC, has been delegated the responsibility to
review supplier enrollment applications to determine if an entity requesting a Medicare
supplier billing number meets the requirements of 42 C.F.R. Part 424 before issuing
billing privileges. CMS Pub. 100-108, Medicare Program Integrity Manual, Chapter 10.
Once a billing number is issued, NSC has the responsibility to ensure that the DMEPOS
supplier continues to meet the standards set forth in the applicable regulations. /d.; CMS
Pre-hearing Brief (PH Br.) at 2.

> [refer to CMS’s exhibits as “CMS Ex.” I refer to Petitioner’s exhibits as “P. Ex.”
2
NSC investigator attempted to complete an inspection to verify Petitioner’s compliance
with supplier standards. Petitioner submitted a corrective action plan on or about May
21, 2008. CMS Ex. 2, at 10-41. On June 10, 2008, CMS notified Petitioner that it had
reviewed the corrective action plan but determined that Petitioner was still out of
compliance with supplier standards. CMS Ex. 2, at 8. On July 10, 2008, Petitioner
submitted a request for reconsideration. CMS Ex. 2, at 6. On September 12, 2008, a
telephone hearing was held before a Hearing Officer. The Hearing Officer upheld the
decision to revoke Petitioner’s supplier number. CMS Ex. 1, at 1-3. On November 17,
2008, Petitioner submitted a hearing request and, on December 1, 2008, the case was
assigned to me for hearing and decision.

I held a prehearing conference in the case on December 15, 2008, at which time I
determined that, because material facts were in dispute, a hearing was necessary.
Specifically, the issue of fact to be determined is whether Petitioner’s owner, Christine
Okezie, was at Petitioner’s premises when the NSC investigator came to the facility on
April 16, 2008. I held the hearing in Houston, Texas, on February 18, 2009. Testifying
‘or CMS was Mark D. Porter, the NSC investigator who conducted the inspections of
Petitioner at issue here. Testifying for Petitioner were: Christine Okezie, Petitioner’s
owner; Odoemelem Okezie, Christine Okezie’s husband; and Kate Koko, Christine
Okezie’s friend. A 103-page transcript (Tr.) of the hearing was prepared. CMS offered
five exhibits. I admitted CMS Exs. 1-5, except that I reserved ruling on CMS Ex. 4, at 8-
10, which consists of photographs taken at the on-site survey in December 2008.
Petitioner objected to the authenticity of these photographs. Tr. at 8. I now admit these
photographs, as I find that Mr. Porter, the NSC witness, has shown that the photographs
were taken in the usual course of business (although signing and dating the photos was
only a requirement of the December inspection). Tr. at 6-8, 25, 37-38, 44-48, 64; CMS
Ex. 5, at 2. Petitioner offered three exhibits. I admitted P. Exs. 1-3.° Tr. at 9-10. I also
marked and admitted ALJ exhibit (ALJ Ex.) 1. Tr. at 93-94. Both parties filed pre-
earing briefs (CMS and P. PH Br.) and post-hearing briefs (CMS and P. Br.). By e-mail
dated April 13, 2009, CMS notified Maxine Winerman, the staff attorney assigned to
assist me in this case, that it did not intend to file a reply brief. Petitioner filed a reply on
April 13, 2008 (P. Reply).

> Following the hearing, I found that page 5 of P. Ex. 2 was missing from the record
copy of the exhibit submitted during the hearing. The same page was missing when
Petitioner filed its pre-hearing exchange. Petitioner faxed three copies of page 5 to me on
February 5, 2009 to complete its pre-hearing exchange. In the absence of objection, I
have placed one of the copies of page 5 sent to me on February 5, 2009 in the record copy
of the exhibit. E-mail dated March 9, 2009.
II. Applicable Law

Section 1861(n) of the Social Security Act (Act) defines medical and other health
services that are eligible for Medicare reimbursement for DMEPOS suppliers. Under
section 1834(j)(1)(A) of the Act, a DMEPOS supplier may not be paid for items provided
to an eligible beneficiary unless the supplier has a supplier number issued by the
Secretary of Health and Human Services (Secretary). A supplier may not obtain a
supplier number unless the supplier meets the standards prescribed by the Secretary. Act,
section 1834(j)(1)(B). A prospective DMEPOS supplier must meet all of the standards
specified at 42 C.F.R. § 424.57(b) and (c) to be issued supplier billing privileges. Once
billing privileges are issued, CMS or NSC may revoke a supplier’s billing privileges for
failure to meet all of the standards specified. 42 C.F.R. § 424.57(d); 42 C.F.R. § 405.874.
CMS or NSC must send notice by certified mail of the revocation and the revocation
becomes effective 15 days after the entity is sent notice of the revocation. 42 C.F.R.

§ 405.874(b).* Supplier standard eight, the standard at issue in this case, states:

(c) Application certification standards. The supplier must meet and must certify
in its application for billing privileges that it meets and will continue to meet the
following standards. The supplier: . . . (8) Permits CMS, or its agents to conduct
on-site inspections to ascertain supplier compliance with the requirements of this
section. The supplier location must be accessible during reasonable business
hours to beneficiaries and to CMS, and must maintain a visible sign and posted
hours of operation.

42 C.F.R. § 424.57(c)(8). CMS has the right to conduct on-site inspections to confirm
compliance with supplier standards. 42 C.F.R. § 424.535(a) states,

(a) Reasons for revocation. CMS may revoke a currently enrolled provider or
supplier’s Medicare billing privileges . . . for the following reasons: . . . (5) On site
review. CMS determines upon on-site review, that the provider or supplier is no
longer operational to furnish Medicare covered items or services, or is not meeting
Medicare enrollment requirements under statute or regulation to supervise
treatment of, or to provide Medicare covered items or services for, Medicare
patients. Upon on-site review, CMS determines that —. . . (ii) A Medicare Part B
supplier is no longer operational to furnish Medicare covered items or services, or
the supplier has failed to satisfy any or all of the Medicare enrollment
requirements, or has failed to furnish Medicare covered items or services as
required by the statute or regulations.

+ 42 C.F.R. § 405.874 was amended effective August 26, 2008. Under the amended
regulations, the effective date of revocation is 30 days after CMS or the CMS contractor
mails the notice of its determination to a supplier. 42 C.F.R. § 405.874(b)(2).
4
A supplier is “operational” when “the . . . supplier has a qualified physical location, is
open to the public for the purpose of providing health care related services, is prepared to
submit valid Medicare claims, and is properly staffed, equipped, and stocked . . . to
furnish these items or services. 42 C.F.R. § 424.502.

A supplier has the right to request reconsideration of a determination to deny or revoke
its billing privileges (or to submit a corrective action plan for a denied or revoked billing
number, 42 C.F.R. § 405.874(e)). 42 C.F.R. § 405.874(c)(2). If the hearing request is
timely, a fair hearing officer not involved in the original determination to revoke the
billing number will schedule a hearing in which both the entity and the carrier may offer
evidence. A supplier has the right to appeal the reconsidered determination to an
administrative law judge.

Once CMS has established a prima facie case that a supplier is not in substantial
compliance with relevant statutory or regulatory provisions, the supplier must prove
substantial compliance by the preponderance of the evidence. MediSource Corporation,
DAB No. 2011, at 2-3 (2006).

Ill. Findings of Fact and Conclusions of Law

1. Mr. Mark D. Porter, the NSC investigator, attempted to complete an inspection of
Petitioner on April 2 and April 16, 2008, to verify Petitioner’s compliance with
DMEPOS supplier standards, but was unable to do so because Petitioner’s office
was not open and thus not operational. Tr. at 24-65, 94-97; CMS Exs. 3, 5.

2. Petitioner was out of compliance with supplier standard eight, and the site
investigator could not determine whether Petitioner was in or out of compliance
with other supplier standards because the site investigator could not access
Petitioner’s office.

3. A DMEPOS supplier must be in compliance with all supplier standards in order to
retain Medicare billing privileges.

4. CMS had a basis to revoke Petitioner’s Medicare billing privileges.
IV. Analysis

CMS asserts that Petitioner failed to be operational because it was not open during two
attempted site inspections, on April 2, 2008 and April 16, 2008, in violation of supplier
5
standard eight.’ CMS asserts that to be in compliance with supplier standard eight, the
physical facility of the supplier must be accessible during reasonable business hours, and,
during the posted hours of operation, staff must be available, so that beneficiaries, CMS,
or NSC can contact the supplier directly and visit the supplier’s location. See
MediSource Corp., DAB No. 2011, at 9. [“The physical facility required of suppliers is
the place where patients can contact the supplier directly . . . Staff must be available at
the facility during posted hours of operation.”] CMS asserts Petitioner was not in
compliance here because, on April 2 and 16, 2008, the NSC investigator was unable to
complete an on-site visit to verify compliance with supplier standards because Petitioner
was not open.

Petitioner asserts that CMS and the NSC Hearing Officer misstated the law. Specifically,
Petitioner refers to the statement in the Hearing Officer decision that:

According to 42 CFR § 424.515(d), “the NSC reserves the right to perform on-site
inspections as a means of verifying information on file with the NSC and confirm
compliance with the supplier standards. If during on-site review a facility is found
closed this becomes grounds for revocation because the facility was found not in
operation.”

Hearing Officer decision dated September 27, 2008, attached to Petitioner’s November
17, 2008 Hearing Request. Petitioner notes that counsel for CMS made an almost
identical statement at hearing:

According to 42 C.F.R. Section 515(d), the NSC, the National Supplier
Clearinghouse, reserves the right to perform on-site inspections as a means of
verifying information on file with the NSC and confirm compliance with supplier
standards. If, during on-site review, a facility is found closed, this becomes
grounds for revocation because the facility was found not in operation.

Tr. at 14. Petitioner argues that the language of 42 C.F.R. § 424.515(d) (a copy of which
is in the record at CMS Ex. 2, at 62) does not reflect this language. It states,

(d) Off Cycle revalidations. (1) CMS reserves the right to perform off cycle
revalidations in addition to the regular 5-year revalidations and may request that a
provider or supplier recertify the accuracy of the enrollment information when
warranted to assess and confirm the validity of the enrollment information

* CMS also notes that Petitioner failed to be open or operational on two additional site
inspections on December 8 and 9, 2008. CMS Br. at 2. It is not necessary for me to
address these alleged failures to decide the case, and I thus limit my analysis to the April
visits.
6
maintained by CMS. Off cycle revalidations may be triggered as a result of
random checks, information indicating local health care fraud problems, national
initiatives, complaints, or other reasons that cause CMS to question the
compliance of the provider or supplier with Medicare enrollment requirements.
Off cycle revalidations may be accompanied by site visits. . . .

Petitioner’s argument that the Hearing Officer and CMS made “gross misstatements”

of law (P. Reply at 1) is overblown. The regulation cited by CMS refers not to the
second half of these statements, but to the first half, and addresses only the right to
perform off cycle revalidations on site visits such as the ones that took place in this case.
That CMS does not reference the second half of the statements is not a mis-statement.
Other sections of the regulations, noted above, support the second half of the statement.°
It is axiomatic that if a facility is not open an investigator cannot determine whether or
not it is otherwise operational. In regard to Petitioner’s assertion that the statement at
section 424.515(d) refers to CMS and not to NSC, and to Petitioner’s inference that there
is something wrong in referring only to CMS and not specifically referring to NSC, that
fact is insignificant. NSC is CMS’s contractor and the regulations permit CMS or its
agents (such as NSC) to verify compliance with supplier standards.

Petitioner also asserts that supplier standard eight does not address the temporary absence
of a supplier’s staff from the supplier’s location. Instead, Petitioner asserts that the
standard mandates that suppliers will “permit” on-site inspections and be accessible
during business hours. Petitioner asserts that CMS cannot establish a prima facie case by
proving that no staff was available on the dates in question, but must prove instead that
Petitioner was not operational (inferring that a temporary absence of staff does not show
that Petitioner was not operational at the time of the inspections).

The evidence shows, however, that Petitioner was not open at the time of the inspections,
and, by not being open, was not operational at the time that the NSC investigator
attempted to conduct his site investigations. By not being open, the NSC investigator
was unable to find out whether or not Petitioner was in compliance with all supplier
standards and beneficiaries were not able to access Petitioner’s services. CMS has
established a prima facie case, unrebutted by Petitioner, that Petitioner was not
operational (because it was not open) on more than one occasion when the NSC
investigator attempted to complete an investigation to verify compliance.

6

Petitioner also asserts that the reliance of the Hearing Officer and CMS on what it
terms this “gross misstatement” of law has detrimentally affected it and denied it due
process of law. Although I disagree, Petitioner’s Constitutional argument is saved for
later appeal, as I do not have the authority to decide Constitutional issues.
7
Specifically, I find the testimony and the affidavit of Mark D. Porter, the NSC
investigator, to be credible and determinative. Tr. at 24-65, 94-97; CMS Ex. 5. Mr.
Porter is a trained and experienced investigator with an extensive background and
familiarity with Medicare supplier regulations and requirements. Jd. His investigation
was conducted in the course of his business as an investigator.

Mr. Porter’s affidavit, CMS Ex. 5, states, at page 2, his general practice in conducting an
on-site visit:

I conduct the initial phase of on-site visits the same for all locations. When I
receive a request for a site inspection, I drive to the location. I find the
suite/office. I make note on the site visit questionnaire if there is a sign for the
business name and if there are posted hours of operation. I will turn the doorknob
and if the door is unlocked, I will enter, announce myself and conduct the site
inspection. If the door is locked, I make a note on the site visit questionnaire
indicating I made a first attempt, and I leave the location. I physically turn the
knob each time with force enough to open the door. I do not leave a notice that I
was at the location. We are no longer required to leave notices of attempts;
however, a couple years ago we were required to leave notices of all attempts.
This was discontinued because it became evident applicants would only appear at
the office after notices of attempts were left. Site visits are all unannounced. I
will later make a second attempt to conduct an on-site investigation during the
posted hours of operation, if there are any; if none, I make the attempt during
reasonably assumed business hours. I will go through the same steps. If the door
is locked when I turn the knob, I make a note on the site visit questionnaire. If this
is the second attempt that the office was closed during the posted hours of
operation, I will annotate only the sections of the site visit questionnaire II (sic)
was able to complete and fail the site inspection. I am required to make only two
attempts of a supplier site visit for a particular location before failing the site
inspection.

I will also take photographs of the location during a site inspection. Photos are
mandatory for every site inspection. The photos are required to substantiate my
visit to a particular location. I am required to take photos of the business sign and
hours of operation (if any), and if I enter the office, photos of the layout of the
office, any and all inventory, paths to show the location is handicap accessible (if
above the 1* floor, include photos of elevator), and any other item that would be
relevant to substantiate any statements and/or findings.
8
I completed the applicable sections of the document entitled Site Investigation for
— Durable Medical Equipment (DME) Suppliers identified and marked as CMS
Exs. 3 and 4. this questionnaire is used in the regular course of my duties as an
investigator for NSC. It was in the regular course of my duties that I completed
the applicable section of the document related to Sky Medical Services.

CMS Ex. 5, at 2-3. Mr. Porter’s affidavit further states at page 3 that:

I received notification on March 31, 2008 to conduct an ad hoc’ site inspection on
Sky Medical Services located at 2650 Fountain View, Ste. 124, Houston, Texas
77057. Documentation shows I made the 1“ attempt at conducting this site
inspection on April 2, 2008 at 10:20 AM and the office was closed. There was no
other sign, notice or indication as to why this supplier was closed during posted
hours of operation. A 2" attempt at conducting this site inspection was made on
April 16, 2008 at 11:55 AM. There was no other sign, notice or indication as to
why this supplier was closed during posted hours of operation. On April 16, 2008,
I failed this site inspection because two attempts were made at conducting this site
inspection. The office was closed on each attempt during posted hours of
operation. No further attempts were required. The supplier was found to be not
operational based on noncompliance with supplier standards #1-21.

Mr. Porter’s hearing testimony is consistent with his affidavit. Tr. at 35-38. Mr. Porter
testified with regard to investigator practice that when he attempts to enter a DMEPOS
supplier in an executive office building (and he does not only survey DMEPOS suppliers
in office buildings, but also surveys suppliers such as CVS, Wal-Mart, or The Scooter
Store, testifying that all DMEPOS suppliers must meet the same standards), if the
supplier has a sign with posted hours, he “turn[s] the knob and walk[s] in.” Tr. at 34. He
testified that investigators do not expect to knock. Although, he acknowledged that for
companies in “problematic” areas that keep their doors locked there might be a sign to
knock. He testified that,

Typically, no. We don’t knock, unless there is a specific sign that says please
knock or ring the bell. But if there’s no such sign . . . then we typically will just
turn the doorknob and expect to walk in because the standards say that they must
be open and accessible to beneficiaries during reasonable business hours.

Tr. at 35. Mr. Porter documented his site visit on April 16, 2008 with photographs. CMS
Ex. 3, at 9-11; Tr. at 36-37, 47. The sign he photographed on the door on April 16, 2008,

7 Mr. Porter explained that the NSC does three types of inspections. An initial on-site
inspection when an entity applies for a supplier number; a re-enrollment inspection every
three years; and an “ad-hoc” request for an out-of-sequence inspection. Tr. 32-33, 55.
9
stated “Sky Medical Services Hours of Operation Mon - Fri 9am - 5 pm” and “No
Soliciting” CMS Ex. 3, at 9; Tr. at 38. Mr. Porter noted as comments on his site visits
“2 attempts; office closed on each attempt; no further attempt necessary” (CMS Ex. 3, at
2), and “2 attempts during parties hours of operation — office closed on each attempt — no
further attempts necessary.” CMS Ex. 3, at 8. Mr. Porter did not call the number listed
on the Site Investigation Request (CMS Ex. 3, at 1), because it is not a requirement to do
so and investigators are prohibited from calling a supplier to tell the supplier they are
coming to make a site visit. Tr. at 59, 62. In fact, to do so would defeat one purpose of
the visit, which is to find out if the supplier is open during stated business hours.

Petitioner seeks to impeach Mr. Porter’s credibility by pointing to Mr. Porter’s testimony
that he did not leave a notice of attempted visit on April 2, 2008, because investigators
were no longer required to, when he did, in fact, do so. That notice read:

A representative of the National Supplier Clearinghouse attempted to conduct an
inspection of your company, Sky Medical Services. The first attempt was made
today, April 2, 2008; however, the visit was unsuccessful because the facility was
closed or an authorized representative was not available. A second unannounced
attempt will be made soon during your posted hours of operation. If we are unable
to complete the inspection, it may be concluded that this company is not open for
business. In addition, the company will be determined to be in non-compliance
with the 21 Medicare DMEPOS Supplier Standards as listed in 42 CFR 424.57(c),
and it will be subject to denial or revocation of its Medicare DMEPOS supplier
number.

ALJ Ex. 1. During CMS’s rebuttal case, Mr. Porter testified that he thought he had been
given the instruction not to leave a notice prior to the April 2 visit, but was mistaken.

Tr. at 46-47, 94-97; ALJ Ex. 1. Ido not find that Mr. Porter’s failure to recall leaving
this notice impeaches the credibility of his well-documented and consistent testimony
that, on two occasions, April 2 and 16, 2008, he attempted to enter Petitioner’s offices but
could not because the door was not open. Moreover, having been notified on April 2,
2008, that an investigator was attempting a site visit, Petitioner was on notice that
someone needed to be available during its posted business hours for inspection (or at least
a notice left on the door as to when someone would be back).

Petitioner also seeks to impeach Mr. Porter’s credibility by referring to earlier site visits
made to Petitioner’s office by Mr. Porter in connection with Petitioner’s initial site
inspection. Mr. Porter conducted a site inspection at Petitioner’s facility on July 5, 2007.
Mr. Porter found Petitioner noncompliant. NSC later found Petitioner in compliance and
issued a billing number, but Mr. Porter did not know why the number was issued, as he
testified that he is not involved after his site inspection. Tr. at 56-57. Ms. Okezie,
Petitioner’s owner, testified that Mr. Porter failed to forward all documentation to the
10

person processing Petitioner’s application and testified that she did so and received her
supplier number. Tr. at 75,77. Petitioner stated that such errors are likely given the vast
territory covered by Mr. Porter. P. Br. at 9, citing Tr. at 48. Petitioner thus infers that
given the large territory covered by Mr. Porter, Mr. Porter may have made mistakes with
regard to the two site investigation visits here. Given the documentation at CMS Ex. 3,
and the fact that the only action Mr. Porter took was to try to enter Petitioner’s facility,
Petitioner’s suggestion does not, in any way, diminish Mr. Porter’s credible testimony.

Petitioner admits that no-one was in Petitioner’s office on April 2, 2008, when Mr. Porter
attempted his site visit. Tr. at 68. Thus, the office was not open on that date. Ms. Okezie
testified that, after April 2, 2008 (and her receipt of Mr. Porter’s notice, ALJ Ex. 1) she
made it a point to be in her office during business hours. Tr. at 69. Petitioner asserts that
the testimony of Ms. Okezie, Mr. Okezie and Ms. Koko, and telephone records from
April 16, 2008, show that Petitioner was open (and thus operational) on April 16, 2008.

Ms. Okezie testified that she was present on April 16, 2008, when Mr. Porter made his
second attempt to conduct a site inspection during Petitioner’s regular business hours of
9:00 a.m. to 5:00 or 5:15 p.m. Tr. at 69. Petitioner asserts this testimony is corroborated
by Ms. Koko, who testified that she visited Ms. Okezie at Petitioner’s offices, arriving
around 10:30 or 11:00 a.m. and left to get lunch around 11:30, returning before noon.

Tr. 20-21. Petitioner also refers to telephone records showing that telephone calls were
made from Petitioner’s landline phone on that date, reflecting a call from Petitioner’s
number at 1:28:37 p.m. and a call to Petitioner’s number at 3:02:31 p.m. P. Ex. 2, at 11;
Tr. at 71. Additionally, Mr. Okezie testified that it was Ms. Okezie’s custom and habit to
keep office hours and that Ms. Okezie was there on April 16, 2008, because he called to
get her lunch, but her friend was there. Tr. at 87. Ms. Okezie does not explain, however,
why her door would have been locked when Mr. Porter arrived.

The evidence adduced by Petitioner does not show that Petitioner was open when Mr.
Porter attempted to enter Petitioner’s facility at 11:55 a.m. on April 16, 2008. The
telephone calls were made on the afternoon of April 16, 2008, after Mr. Porter attempted
to enter. And, I find the testimony of Mr. Porter, and the site report and attached
photographs at CMS Ex. 3, to be more credible than the evidence adduced by Petitioner.
In sum, I find that Mr. Porter attempted to enter Petitioner’s premises twice, was unable
to enter because the door was locked, took the photographs included in CMS Ex. 3 on
April 16, 2008, and left, all in the ordinary course of his business. Because Petitioner’s
office was not open: Petitioner’s office was not accessible during the reasonable business
hours Mr. Porter sought to enter; CMS was not able to conduct the on-site inspection to
ascertain Petitioner’s compliance with supplier standards; and Petitioner was not in
compliance with supplier standard eight.

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V. Conclusion

A supplier must comply with all supplier standards. NSC was unable to access
Petitioner’s office on two occasions in April, during posted hours of operation, to verify
compliance with all surveyor standards. Petitioner’s noncompliance with supplier
standard eight is a sufficient basis for the revocation of its Medicare billing privileges.

/s/
Alfonso J. Montano
Administrative Law Judge