Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Fullerton-Kimball Medical & Surgical Center — Laboratory,
(CLIA ID# 14D1047993),

Petitioner,
v.
Centers for Medicare & Medicaid Services.
Docket No. C-16-326
Decision No. CR4694

Date: August 30, 2016

DECISION

I grant summary judgment in favor of the Centers for Medicare & Medicaid Services
(CMS), sustaining its determination to impose remedies against Petitioner, Fullerton-
Kimball Medical Surgical Center — Laboratory. The remedies that I sustain are the
following:

e Suspension of Petitioner’s certificate to perform testing subject to the Clinical
Laboratory Improvement Amendments of 1988 (CLIA), Public Law 100-578
(section 353 of the Public Health Services Act, 42 U.S.C. § 263a);

¢ Cancellation of Petitioner’s approval to receive Medicare payments effective
December 22, 2015;

¢ Civil money penalties of $7,500 for each day of a three-day period beginning
December 19, 2015 and running through December 21, 2015; and

¢ Revocation of Petitioner’s CLIA certificate.
I. Background

Petitioner, a clinical laboratory, filed a hearing request in order to challenge CMS’s
remedy determinations. CMS moved for summary judgment. CMS filed 14 proposed
exhibits with its motion, which are identified as CMS Ex. 1-CMS Ex. 14. Petitioner
opposed the motion and filed 35 proposed exhibits in opposition, which are identified as
P. Ex. 1-P. Ex. 35.

I receive the parties’ proposed exhibits into the record for purposes of deciding the
motion for summary judgment. I make no findings as to whether any or all of these
exhibits would be admissible were I to hold an evidentiary hearing.

IL. Issues, Findings of Fact and Conclusions of Law
A. Issues

The issues are whether Petitioner failed to comply with CLIA conditions of participation
and whether CMS’s remedy determinations are authorized by law and reasonable.

B. Findings of Fact and Conclusions of Law

This case is governed by CLIA and by regulations published at 42 C.F.R. Part 493. I
discuss the Act and regulations in more detail below. However, I note preliminarily, that
there is no dispute between the parties as to the law applying to this case. Furthermore,
Petitioner does not assert that the facts alleged by CMS, if true, would not support the
imposition of the remedies that CMS determined to impose. Rather, Petitioner’s
argument is based strictly on what it contends is a dispute as to the material facts.

CMS premises its case against Petitioner on the assertion that, as of a survey conducted
on November 18, 2015, Petitioner was not complying with six distinct CLIA conditions
of participation. CMS Ex. 3. Specifically, according to CMS, Petitioner was not
complying with conditions stated at: 42 C.F.R. § 493.1213, governing toxicology
services and testing; 42 C.F.R. § 493.1250, governing analytic systems; 42 C.F.R.

§ 493.1441, governing the role and duties of the laboratory director; 42 C.F.R.

§ 493.1447, governing the role and duties of a technical supervisor; 42 C.F.R.

§ 493.1459, governing the role and duties of a general supervisor; and 42 C.F.R.

§ 493.1487, governing the role and duties of testing personnel. CMS asserts additionally
that it provided Petitioner with the opportunity to file credible allegations of compliance
to address the deficiencies that CMS had identified. According to CMS, Petitioner did so
but its evidence of compliance was inadequate and incomplete. CMS Ex. 5.

The facts offered by CMS, if not contested, establish that Petitioner was noncompliant
with the six conditions of participation cited in the Statement of Deficiencies from the
November 18, 2015 survey. The allegations of noncompliance, as I shall discuss, involve
failures by Petitioner to comply with specific certification standards. Its noncompliance
with these standards is sufficient to establish condition-level deficiencies in the way
Petitioner operated its laboratory.

Petitioner asserts that it always has been and remains in full compliance with all CLIA
requirements and that there is at least a dispute as to material facts that precludes entry of
summary judgment. But, on close analysis, Petitioner doesn’t actually rebut the facts
offered by CMS. As I shall discuss, with the exception of one of the conditions
governing the laboratory’s technical supervisor, Petitioner for the most part doesn’t really
challenge the fact findings made by the surveyor on November 18, 2015, nor does it deny
the incompleteness and inadequacy of its plan of correction. Rather, Petitioner proffers
an alternate universe of facts that, it contends, establishes a true picture of its operations.
I have examined these asserted facts, which I assume to be true for purposes of ruling on
CMS’s motion, and I find them to be irrelevant because they beg the crucial questions of
whether Petitioner was out of compliance as of the November 18" survey and whether it
demonstrated compliance with its subsequent filing of allegations of compliance.

Based on the undisputed facts, I find that Petitioner failed to comply with five of the six
conditions that CMS contends that it violated. The only condition about which I find a
genuine dispute as to material facts is the condition governing technical supervisor stated
at 42 C.F.R. § 493.1447. As I shall discuss, Petitioner’s noncompliance with the other
five conditions justifies imposition of all of the remedies CMS determined to impose.

CMS contends that Petitioner failed as of November 18, 2015 to comply with the
Toxicology and Analytic Systems conditions at 42 C.F.R. §§ 493.1213 and 493.1250

for three reasons. First, it asserts that Petitioner was required to have a comprehensive
procedures manual that advised laboratory employees about the performance of a range
of necessary testing tasks. CMS contends that Petitioner failed to produce that manual
when its surveyor demanded it. 42 C.F.R. §§ 493.1251(b) and 493.1242(a); CMS Ex. 1
at 3-6, 10-11; CMS Ex. 9; CMS Ex. 14 at §§ 8-12. Nor did the laboratory, according to
CMS, have a comprehensive manual available that addressed when and how an employee
should take corrective action, among other things, to address problems, or proceed in the
event of imminently life threatening results. 42 C.F.R. § 493.1251(b); CMS Ex. | at 11;
CMS Ex. 9; CMS Ex. 14 at § 12.

Petitioner concedes that it was unable to produce requested manuals on November 18".
Petitioner’s pre-hearing brief at 5. It argues that it was compliant with the requirement
that it maintain manuals because those manuals in fact existed even if the staff was
unable to find them and offer them to the surveyor. P. Ex. 3.' For purposes of deciding

' Petitioner asserts that its laboratory director was out of the country on November 18,
2015. It is unclear to me whether Petitioner is suggesting that his absence condones its
CMS’s motion I accept Petitioner’s assertion as true. It is irrelevant. Those manuals, to
be meaningful, had to be available to Petitioner’s staff on November 18" so that the staff
could refer to them as needed. The fact that the manuals — even if they existed — could
not be located on that date rendered them useless to the staff. For compliance purposes, it
was as if the manuals did not exist.

Petitioner made allegations of compliance on January 7 and 8, 2016. In responding to
Petitioner’s allegations, CMS noted that the manual portions that Petitioner provided on
January 7 and 8 were substantially incomplete. CMS Ex. 5. Petitioner doesn’t deny that
what it submitted on January 7 and 8 was incomplete, but it now asserts that its policy
and procedures manual is complete and that it addresses all of the concerns raised by
CMS. Petitioner’s pre-hearing brief at 6-7. For purposes of deciding this case I accept
Petitioner’s representation that it has corrected all of the inadequacies that CMS
identified with the manual portions that Petitioner located and submitted. But, Petitioner
did not prove that its manuals were complete as of November 18, 2015 or as of January 7
and 8, 2016. Rather, its proffered facts and arguments address the current condition of its
manuals.

Petitioner’s assertions about its manuals’ current condition are irrelevant because the
current status of the manuals isn’t at issue in this case. What matters is whether
Petitioner was in compliance as of the November 18 survey or as of January 7 and 8,
2016. CMS made its remedy determination based on its evaluation of Petitioner’s status
as of those dates and it is under no obligation to accept Petitioner’s subsequent corrective
actions. CMS’s inspections of clinical laboratories are not open-ended processes in
which the laboratories get infinite bites at the apple until they get things right. CMS
properly set deadlines and Petitioner failed to establish compliance by those deadlines.
That is what matters here and not what may have occurred subsequently.

Second, CMS asserts that Petitioner failed to comply with the Toxicology and Analytic
Systems requirements because at the November 18, 2015 survey Petitioner could not
demonstrate that it was conducting tests to verify the performance of its equipment.

CMS alleges additionally that Petitioner failed to demonstrate that it performed tests of
control materials on each day that patient specimens were being tested. 42 C.F.R.

§§ 493.1253(b)(2) and 493.1256(d)(3)(i), (g); CMS Ex. 1 at 12-15; CMS Ex. 14 at §§ 12-
13. On at least one date, June 16, 2015, according to CMS, Petitioner conducted a patient

inability to produce laboratory manuals on that date. It does not. Moreover, I note that
Petitioner received advanced notice of the November 18 survey by letter dated November
4, 2015. It had nearly two weeks to prepare for that survey and it could easily have made
its manuals accessible during that period. See CMS Ex. 2.
test but was unable to show that it had conducted quality control testing. CMS Ex. 11 at
2; CMS Ex. 14 at J 13. CMS also asserts that on dates when the laboratory alleged that it
had conducted quality control tests the test results were incomplete. CMS Ex. 12; CMS
Ex. 14 at ¥ 13.

Petitioner replies to CMS’s assertions by stating flatly that it “is, and always has been,
compliant with all . . . [quality control] requirements and performs . . . [quality control]
testing as required.” Petitioner’s pre-hearing brief at 9. It then offers evidence
purporting to prove that its quality control testing is compliant as of now. But, that begs
the question as to its compliance on November 18. Petitioner does not deny that it was
unable to show that it had conducted quality control testing on June 16, 2015 or that the
test results that it showed to the surveyor on November 18" were incomplete.

Petitioner seems to argue that its quality control testing was compliant as of November
18, 2015 even if it failed to provide proof of that to the surveyor on that date. According
to Petitioner:

It can be established and verified that performance characteristics of all
assays in the subspecialty of toxicology testing were completed, reviewed
and signed in a timely manner. See P. Ex. 22. All required . . . [quality
control testing] was performed before any toxicology testing was
completed. The . . . [quality control] records prove compliance. See e.g.
P. Ex. 19; see also P. Ex. 20 and P. Ex. 23....

Petitioner’s pre-hearing brief at 11. However, and notwithstanding Petitioner’s
representations, it has offered no evidence to show that on November 18" it had
performed the tests that CMS alleges Petitioner failed to perform.

Specifically, Petitioner did not rebut CMS’s assertion that it had failed on at least one
occasion, June 16, 2015, to conduct quality control testing as support of a patient test.
Nor did it rebut the assertion that there were dates where quality control test results were
incomplete. Petitioner produced exhibits — P. Ex. 19 and P. Ex. 20 — that Petitioner
apparently purports to show quality control test results. But, these results, if that’s what
they are, are for just two dates, October 9 and 12, 2015.” Petitioner has made no showing
by producing test results that it did quality control testing on June 16, 2015. Nor did

> Throughout its argument Petitioner repeatedly offers to provide more evidence in the
event that what it has provided is inadequate. Evidently, it labors under the
misperception that the hearing in this case is open ended and that it has infinite
opportunity and time to amend its submission. That is absolutely contrary to what I
ordered the parties to do by way of pre-hearing exchanges. Petitioner was obligated to
produce all of the evidence on which it intended to rely by a date certain. It cannot hold
back evidence and offer vaguely, to provide more if requested to do so.
Petitioner produce evidence showing that it did quality control testing on the several
dates requested by the surveyor during the November 18, 2015 survey. CMS Ex. 14 at J
13.

Petitioner relies on two other exhibits, P. Ex. 19 and P. Ex. 20, as ostensible rebuttal of
CMS’s assertions. But, these exhibits do not show that Petitioner was doing requisite
testing on the dates at issue.

Third, CMS alleges that Petitioner erred in the way that it documented and reported
toxicology test results. Specifically, CMS contends that, with respect to three patients,
Petitioner failed to document the dates and times that it received specimens to be tested.
42 C.F.R. § 493.1242(b); CMS Ex. 1 at 6; CMS Ex. 11; CMS Ex. 14 at ¥ 11. CMS
contends additionally that Petitioner failed to include in its test results a disclaimer that
the manner in which the toxicology tests were conducted was not FDA-approved.

42 CFR. § 493.1291(c); CMS Ex. | at 15-16.

Petitioner did not rebut these allegations. It has offered no evidence rebutting CMS’s
contention that it failed to document the dates and times it received specimens for three
individuals, nor did it provide evidence showing that it put the requisite disclaimer on test
results. Rather, Petitioner merely states that it has performed tests timely and that it now
puts the requisite disclaimer on test results. These assertions again simply beg the
question of whether Petitioner was compliant when it was surveyed on November 18,
2015.

CMS makes the following assertions concerning Petitioner’s noncompliance with the
management and staffing conditions at 42 C.F.R. §§ 493.1441, 493.1447, 493.1459 and
493.1487. First, it contends that Petitioner was not in compliance with the laboratory
irector condition at 42 C.F.R. § 493.1441 because Petitioner’s laboratory director, Dr.
Arana, failed to provide specifications of the responsibilities of laboratory personnel.
CMS Ex. | at 17-24; CMS Ex. 14 at ¥ 14. Second, it contends that Petitioner failed to
comply with the technical supervisor and general supervisor requirements of 42 C.F.R.
§§ 493.1447 and 493.1459 because the laboratory had neither a technical supervisor nor a
qualified general supervisor on its staff. CMS Ex. 1 at 21-24; CMS Ex. 7; CMS Ex. 14 at
4 15. Finally, CMS asserts that Petitioner failed to comply with the testing personnel
requirements of 42 C.F.R. § 493.1487 because testing personnel at Petitioner’s laboratory
were not qualified to conduct high complexity tests. CMS Ex. | at 21-28; CMS Ex. 14 at
q 1s.

Petitioner denies CMS’s allegations as “wholly inaccurate.” Petitioner’s pre-hearing
brief at 13. It contends that it:

has sufficient and qualified laboratory personnel present at the laboratory
during all testing, including high complexity testing. All laboratory
personnel’s roles are properly defined, and each laboratory personnel is
qualified to complete assigned tasks.

Id. at 13-14. Significantly, Petitioner makes its assertions in the present tense. I will
accept these assertions as true for purposes of ruling on CMS’s motion, but they are
irrelevant to the extent that they do not address Petitioner’s compliance as of the
November 18" survey and in January 2016. Asserting that Petitioner is presently
compliant does not establish that it was compliant on earlier dates.

Petitioner relies on two exhibits, P. Exs. 25 and 26, to support its assertion that laboratory
personnel’s roles are properly defined. These two documents spell out the duties of
Petitioner’s staff. But, they are undated and Petitioner does not allege that they existed as
of November 2015 or January 2016. For that reason they do not rebut CMS’s assertions
that, as of the date of the survey, Petitioner’s laboratory director had failed to specify the
duties of laboratory staff.

Petitioner discusses at length its decision to hire a new laboratory director to replace Dr.
Arana and it asserts that its new director is fully qualified to perform in that capacity. It
also argues that Dr. Arana was qualified, by virtue of his education and work experience,
to perform the duties of laboratory director. Petitioner’s pre-hearing brief at 14-15.
Petitioner concedes that Dr. Arana sometimes erred in failing to sign documents timely.
However, it asserts that these conceded errors are “moot” because it has replaced Dr.
Arana. Id. at 15-16.

I find these assertions — assuming their truth — to be irrelevant. The fact that Petitioner
replaced its director after the survey was complete does not derogate from CMS’s
assertions that the director as of the date of the survey — Dr. Arana — was not performing
his duties consistent with conditions of participation. It is essentially the same argument
that Petitioner makes repeatedly, that it corrected whatever was wrong subsequently.
This argument is irrelevant for the reasons I have stated.

Petitioner asserts that it did have a technical supervisor as of the November 18" survey
and as proof of that contention it has offered the curriculum vitae of Mohammed A.
Elmannan, M.D., and a consulting contract with that individual dated December 2013.

P. Ex. 32; dd. at 11-15. On its face this document appears to show that Petitioner
complied with the Technical Supervisor condition of participation and I find a dispute of
material fact as to that issue. I do not grant summary judgment in favor of CMS on the
issue of whether Petitioner complied with the technical supervisor condition.

However, I find that Petitioner failed to rebut CMS’s allegations concerning its failure, as
of the November 18" survey, to have a general supervisor as is required by 42 C.F.R.

§ 493.1459. In order to serve as a general supervisor, an employee of the laboratory must
either qualify as a technical supervisor pursuant to the requirements of 42 C.F.R.
§ 493.1449, or meet the laboratory director requirements of 42 C.F.R. § 493.1443.
42 C.F.R. § 493.1461(b). Among other things, the requirements for both technical
supervisor and general supervisor include requirements that such individuals have
degrees as doctors of medicine or equivalent educational attainment in other specialties.

As of November 18, 2015, Susan DeVries, the individual purporting to be Petitioner’s
general supervisor, held an associate’s degree as a laboratory technician. CMS Ex. 14 at
4 15. That is plainly inadequate to qualify her as Petitioner’s general supervisor and for
that reason Petitioner failed to comply with the condition governing general supervisor.

Petitioner argues that Ms. DeVries is “qualified under § 493.1461 of this subpart to
provide general supervision in accordance with § 493.1463 of this subpart.” However,
Petitioner did not offer anything to rebut CMS’s assertion that she lacked the
requirements for general supervisor mandated by the applicable regulations.

CMS asserts that Petitioner failed to comply with the regulatory requirements governing
testing personnel because two of the three individuals who were performing high
complexity testing had only high school degrees. CMS Ex. 14 at § 15. The regulatory
requirements governing personnel performing high complexity testing require these
individuals to have advanced training. 42 C.F.R. § 493.1487. Having a high school
degree without such training plainly disqualifies an individual from performing high
complexity testing and a laboratory’s utilization of such individuals to perform high
complexity tests would be a condition-level violation of requirements.

Petitioner did not rebut CMS’s assertions. It asserts that, as of the time of the survey, Ms.
DeVries was “testing personnel,” avoiding answering CMS’s charge that other
individuals who were manifestly unqualified as of the survey were performing high
complexity tests. Petitioner’s pre-hearing brief at 16. Petitioner also argues that its
current staff includes several individuals who are qualified to perform high complexity
tests. Id. That begs the question of whether Petitioner was using unqualified personnel
as of the survey date or in January 2016 to perform high complexity tests.

I have found that Petitioner was noncompliant with five of the six conditions that CMS
alleges Petitioner violated as of the November 18" survey and in January 2016. I find
that the remedies that CMS determined to impose, including civil money penalties, are
justified by the degree of Petitioner’s noncompliance. It is unnecessary that CMS
establish that Petitioner failed to comply with all six conditions, as alleged originally, in
order to justify the remedies at issue.

In discussing these remedies, I note that Petitioner made no arguments concerning any of
them. It effectively concedes that all of these remedies would be appropriate were it to
be found noncompliant as alleged originally by CMS. I would not address the issue of
remedy at all but for the fact that I find that summary judgment is appropriate as to five
of the six conditions about which CMS alleges noncompliance.

Regulations governing imposition of remedies against noncompliant laboratories are set
forth at 42 C.F.R. Part 493, Subpart R. CMS may impose principal and alternative
sanctions against a laboratory where noncompliance consists of failure to comply with
even just one condition of participation. 42 C.F.R. § 493.1804(b)(2), incorporating

42 C.F.R. §§ 493.1806 and 493.1807. CMS has discretion to determine what remedies to
impose where there is condition-level noncompliance. Edison Med. Labs., DAB No.
1713, at 2 (1999), aff'd, Edison Med. Labs., Inc. v. Thompson, 250 F.3d 735 (3 Cir.
2001). When CMS revokes a laboratory’s CLIA certificate, it must cancel the
laboratory’s approval to receive Medicare reimbursement for its services. 42 C.F.R.

§§ 493.1808(a), 493.1842(a).

Thus, all of the remedies that CMS determined to impose, with the exception of the
imposition of civil money penalties, are justified as a matter of law by Petitioner’s failure
comply with just one CLIA condition of participation. Petitioner’s noncompliance with
five conditions of participation is more than enough to sustain CMS’s remedy
determinations.

That leaves the issue of the civil money penalties of $7500 per day for each day of a
three-day period. CMS based these penalties on Petitioner’s failure to comply with six
conditions of participation. Does failure to comply with five of the six conditions also
support the imposition of penalties in these amounts? I conclude that it does.

Civil money penalties are authorized where a laboratory manifests condition-level
noncompliance, whether or not that deficiency poses immediate jeopardy for patients
whose specimens are being tested by that laboratory. 42 C.F.R. §§ 493.1806(c)(3),
493.1834. Penalties in a range of from $3050 to $10,000 per day may be imposed where
immediate jeopardy exists. 42 C.F.R. § 493.1834(d)(2). There are regulatory factors
governing the determination of penalty amount and these include the nature, scope,
severity, and duration of a laboratory’s noncompliance. 42 C.F.R. § 493.1834(d)(1).

In this case, CMS found immediate jeopardy level noncompliance because it found that
the noncompliance was likely to cause serious injury, harm or death to individuals served
by the laboratory. There is ample basis for that determination even if Petitioner was
noncompliant with five, and not all six, of the conditions alleged by CMS. Among other
things, Petitioner was using personnel to perform high complexity tests who were
manifestly unqualified to perform those tests. On the day of the survey, manuals that
addressed issues or problems that might come up during the performance of high
complexity tests were unavailable to Petitioner’s staff. So, untrained staff were
10

potentially left in the dark as to how to address problems that might arise with tests
whose outcomes could be life-altering for the individuals whose specimens were being
tested. That level of noncompliance is certainly immediate jeopardy.

The penalty amounts of $7500 per day that CMS determined to impose had the remedial
intent of inducing Petitioner to come back into compliance. I find that they were
commensurate with the degree of seriousness of that noncompliance and appropriate
based on the five conditions with which Petitioner failed to comply.

/s/
Steven T. Kessel
Administrative Law Judge


DEPARTMENT OF HEALTH AND HUMAN SERVICES
Departmental Appeals Board

Civil Remedies Division

Brookdale Mountain View
(CCN: 06-5392)

Petitioner,
v.
Centers for Medicare & Medicaid Services.
Docket No. C-16-688
ALJ Ruling No. 2016-18

Date: August 30, 2016

ORDER OF DISMISSAL

On July 1, 2016, Petitioner, through counsel, submitted a request for hearing appealing
the determination of the Centers for Medicare & Medicaid Services (CMS) “to impose a
denial of payment for new admissions . . . as a result of a Recertification Survey ending
on January 14, 2016.” Request for Hearing at 1. Petitioner also contended that
“{a]lternatively, and contrary to CMS’s and [the state agency’s] contentions, Brookdale
Mountain View asserts that it had achieved and maintained substantial compliance as of
February 26, 2016... .” Request for Hearing at 2. In an Attachment 5 that was
referenced in its hearing request, Petitioner stated “[t]he facility was in compliance with
the requirements under [Tag] F315 [42 C.F.R. § 483.25(d)] by February 26, 2016.”

On July 22, 2016, in lieu of issuing an Acknowledgment and Pre-Hearing Order, I
ordered Petitioner to show cause why its hearing request should not be dismissed. At that
time, I explained that it appeared that Petitioner had filed an untimely hearing request.
Petitioner filed a response to my Order (P. Response), and CMS in turn filed a reply
(CMS Reply). Petitioner, with prior approval, filed a sur-reply on August 22, 2016 (P.
Sur-reply).
Discussion

On January 14, 2016, the Colorado Department of Public Health and Environment
(CDPHE) completed a recertification survey in conjunction with an abbreviated survey of
Petitioner and assessed 18 deficiencies with Medicare program requirements. Request
for Hearing, Attachment 4. On February 17, 2016, CMS notified Petitioner, as relevant
for the purposes of this Order, that it would impose a per-instance civil monetary penalty
(CMP) for one deficiency (42 C.F.R. § 483.25(j) (Tag F327)), and that effective March 3,
2016, it would impose a denial of payment for new admissions (DPNA).! Request for
Hearing, Attachment | at 1-2. On April 1, 2016, Petitioner notified CMS that it had
waived its right to a hearing based on the January 14, 2016 survey. CMS Exhibit (CMS
Ex.) 2. Although Petitioner had been explicitly informed by CMS’s February 17, 2016
letter that it could request a hearing before an administrative law judge (ALJ) within 60
days of receipt of the letter, Petitioner did not timely request a hearing. See Request for
Hearing, Attachment 1.

Another survey on February 26, 2016, revealed that Petitioner was out of compliance
with seven additional participation requirements. CMS notified Petitioner of the survey
results in a letter dated March 9, 2016, at which time CMS informed Petitioner that the
DPNA remedy, which had been in effect since March 3, 2016, would continue until the
facility substantially complied with program requirements. CMS once again provided
notice that Petitioner could appeal to an ALJ within 60 days of receipt of the letter, but
the facility did not appeal the March 9, 2016 determinations that it continued to be out of
compliance following a February 26, 2016 survey and that the previously imposed DPNA
would continue. CMS Ex. I.

CDPHE conducted a re-visit survey on May 3, 2016, and determined that the facility was
back in compliance with participation requirements as of that date. CDPHE reported that
the date of compliance for 17 of the deficiencies cited in the January 14, 2016 survey was
February 26, 2016, but that the date of compliance for the remaining deficiency cited in
the January 14, 2016 survey, cited as Tag F315, was May 3, 2016. CMS Ex. 4. With
respect to the seven deficiencies cited in the February 26, 2016 survey, a Post-
Certification Revisit Report indicates that the facility returned to substantial compliance
in April 2016. CMS Ex. 5. A May 9, 2016 letter from CMS informed Petitioner that the
DPNA had been discontinued as of midnight on May 3, 2016, although CMS contends in
its reply that the correct end date for the DPNA was midnight on May 2, 2016. Request
for Hearing, Attachment 3; CMS Response at 3 n.1.

' CMS may deny payment for all new admissions to a facility when a facility is not in
substantial compliance with Medicare requirements; payments may resume when a
“facility achieves substantial compliance as indicated by a revisit or written credible
evidence acceptable to CMS ....” 42 C.F.R. § 488.417(c)(1).
Petitioner argues that dismissal is inappropriate. Petitioner contends that it “was in
substantial compliance as of February 26, 2016[,] with all deficiencies cited during the
January 14, 2016 survey.” P. Response at 4 (emphasis omitted). Petitioner further
contends that “[t]he hearing request was clearly filed within 60 days of CMS’s May 9
notice” and “the hearing request challenging the date of substantial compliance is timely
filed.”? P. Response at 4. In response, CMS argues that Petitioner failed to file a timely
request with respect to the relief sought in its request for hearing. CMS contends that
“Petitioner did not file a timely hearing request to challenge the findings of substantial
noncompliance as a result of the January 14, 2016 and the February 26, 2016 surveys and
cannot establish good cause for failing to meet the filing deadline.” CMS Reply at 5.
CMS argues that Petitioner waived its right to challenge the findings of noncompliance
from the January 14, 2016 survey and did not timely request a hearing after receiving the
letters dated February 17 and March 9, 2016. CMS Reply at 6-7.

As relevant for purposes of the instant discussion, Petitioner did not submit a request for
earing within 60 days of receipt of the February 17, 2016 letter that informed it that
CMS had imposed remedies based on deficiencies identified at a January 14, 2016
survey. In fact, Petitioner waived its right to a hearing pursuant to 42 C.F.R. § 488.436
so that the CMP would be reduced by 35 percent. CMS Ex. 2. Petitioner, in its request
for hearing, “appeals from a decision... to impose a... DPNA... as a result of a
Recertification Survey ending on January 14, 2016.” Request for Hearing at 1.
However, Petitioner failed to timely appeal following receipt of the February 17, 2016
letter that informed it that a CMP and DPNA would be imposed. As Petitioner did not
timely appeal the imposition of the DPNA, Petitioner’s appeal on this basis is untimely.

The subsequent March 9, 2016 letter informed Petitioner that CMS had identified another
seven deficiencies at the time of the February 26, 2016 survey. With respect to the
DPNA, the letter informed Petitioner that “[t]his remedy was effective March 3, 2016,
and will continue until the facility is in substantial compliance with all participation
requirements.” CMS Ex. | at 3. Petitioner was given appeal rights, but it did not request

2 Petitioner inexplicably does not reference either the February 26, 2016 survey or
CMS’s March 9, 2016 letter that notified it of new deficiencies and continued remedies in
either its request for hearing or its initial response to the Order to Show Cause.
Furthermore, Petitioner explicitly stated that it appealed the imposition of the DPNA “as
a result of the Recertification Survey ending on January 14, 2016,” and alternatively,
“maintained substantial compliance as of February 26, 2016 as alleged in the Plan of
Correction addressing the alleged non-compliance . . . identified in Form CMS-2567L for
the January 15, 2016 survey... .” Request for Hearing at 1-2. Thus, Petitioner, in its
request for hearing, seeks relief only with respect to the remedies imposed as a result of
the January 14, 2016 survey. Petitioner did not assert that it was challenging any remedy
that resulted from the February 26, 2016 survey.
a hearing to challenge the deficiencies noted during the February 26, 2016 survey or the
continued remedy of the DPNA at the time of the March 9, 2016 letter. While Petitioner
raised an “alternative” argument in its request for hearing that “it achieved substantial
compliance as of February 26, 2016” (Request for Hearing at 2), it did not timely submit
a request for hearing following receipt of the March 9, 2016 notice imposing continued
remedies based on the noncompliance found at the February 26, 2016 survey. CMS
specifically notified Petitioner on March 9, 2016, that it had identified another seven
deficiencies and that Petitioner had not returned to substantial compliance as of that date;
therefore, Petitioner had 60 days from the date of receipt of the notice to challenge this
finding, which it did not do. Thus, any current argument that Petitioner returned to
substantial compliance as of February 26, 2016, is simply untimely.

Relevant to this Order, Petitioner stated two bases for challenging CMS’s actions in its
request for hearing: 1) the imposition of the DPNA as a result of the January 14, 2016
survey; and 2) that it had, alternatively, returned to compliance on a specific date —
February 26, 2016 — following the January 14, 2016 survey. Request for Hearing at 1-2.
Only after I ordered Petitioner to show cause why its appeal should not be dismissed did
Petitioner raise, for the first time, that it is also challenging the duration of the DPNA
remedy. However, other than stating in its request for hearing that it had returned to
compliance on the specific date of February 26, 2016, a date prior to the imposition of the
DPNA, Petitioner has not made any allegation that it came back into compliance at a date
prior to May 3, 2016, such that the DPNA should be shorter in duration.> Thus, while
Petitioner contends that a party can properly challenge the duration of noncompliance,
Petitioner has not actually argued that it returned to compliance on any date other than
February 26, 2016, which is the date of the survey that was the basis for a determination
of continued noncompliance and remedies. Furthermore, Petitioner’s request for hearing
addressed only the January 14, 2016 survey and is silent regarding the additional
noncompliance cited at the February 26, 2016 survey that was a basis for the continuation
of the DPNA.

l agree with Petitioner, as does CMS, that the Departmental Appeals Board “has
determined that a provider may appeal the duration of a remedy outside of the 60-day
deadline of the original imposition notice, once it receives notice of the full duration of

3 It is difficult to reconcile Petitioner’s argument that it returned to compliance on
February 26, 2016, in light of its failure to appeal the March 9, 2016 determination citing
seven new deficiencies that were identified at the survey on February 26, 2016. In
making such an argument, Petitioner is essentially contending that not only had it
returned to substantial compliance based on the original 18 deficiencies cited in the
January 2016 survey, but that it should not have been cited for the additional seven
deficiencies documented in the February 2016 survey. However, I reiterate that
Petitioner did not timely appeal any of the 25 deficiencies found during the two surveys.
the remedy,” and I acknowledge that Petitioner “has the right to demonstrate it achieved
substantial compliance earlier than the date found” in the May 9, 2016 letter. CMS Reply
at 8; P. Response at 5; see, e.g., Mimiya Hosp., DAB No. 1833 (2002); Taos Living Ctr.,
DAB No. 2293 (2009); Elant at Fishkill, DAB No. 2468 (2012). I further acknowledge
that Petitioner could have appealed the May 9, 2016 CMS determination with respect to
the date it was found to have returned to substantial compliance — had it chosen an
alleged date of return to substantial compliance not already foreclosed by a final,
unappealed CMS determination.

However, Petitioner, in its request for hearing, has contended as an alternative argument
that it returned to substantial compliance on February 26, 2016; CMS determined, in a
final and unappealed determination issued on March 9, 2016, that Petitioner did not
return to substantial compliance as of that date. Request for Hearing at 2; CMS Ex. | at
1, 2. Petitioner has not otherwise disputed the duration of the DPNA (i.e., by arguing
that it returned to substantial compliance on a date after the DPNA went into effect but
before CMS determined it ended); in fact, based on Petitioner’s assertions in the request
for hearing, Petitioner contends that a DPNA should not have been imposed at all (based
on its alleged return to substantial compliance on February 26, 2016). Petitioner does not
seek any relief in its request for hearing that has not already been precluded by a final and
unappealed determination, and Petitioner has not amended its request for hearing. 42
C.F.R. § 498.40(b) (request for hearing must identify specific issues, findings of fact, and
conclusions of law and the basis for contending that the findings and conclusions are
incorrect). Nor has Petitioner requested an extension of the filing deadline. 42 C.F.R.

§ 498.40(c). As such, Petitioner has no right to a hearing on the specific issues raised in
its request for hearing. 42 C.F.R. § 498.70(b). I therefore dismiss Petitioner’s request for
hearing.

It is so ordered.

/s/
Leslie C. Rogall
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Andrew S. Martin, M.D.
(NPI: 1417007345)
(PTAN: V110196),
Petitioner,
v.
Centers for Medicare & Medicaid Services.
Docket No. C-16-293
Decision No. CR4693

Date: August 29, 2016

DECISION

The Centers for Medicare & Medicaid Services (CMS), through its Medicare
administrative contractor, revoked the Medicare enrollment and billing privileges of
Andrew S. Martin, M.D. (Petitioner or Dr. Martin) pursuant to 42 C.F.R. § 424.535(a)(9)
because Dr. Martin failed to report to CMS within 30 days that his license to practice
medicine had been suspended by the Nevada State Board of Medical Examiners (State
Board). Dr. Martin acknowledges that he did not report his license suspension to CMS
within 30 days as was required. Accordingly, CMS had a legal basis to revoke Dr.
Martin’s Medicare enrollment and billing privileges.

I. Background

Dr. Martin is an orthopedic surgeon. Petitioner’s Exhibit (P. Ex.) 2 at 4. He was
originally licensed to practice medicine in the State of Nevada on April 20, 2005. P. Ex.
2 at 43. The State Board suspended Dr. Martin’s license to practice medicine on
September 23, 2014. P. Ex. 2 at § 6. On October 5, 2014, Dr. Martin entered an inpatient
rehabilitation program for chemical dependency, where he was treated until November 7,
2014. P. Ex. 2 at § 7; see also P. Ex. 3 at 14. After his release from the inpatient
rehabilitation program, he continued treatment on an outpatient basis. P. Ex. 2 at § 7; see
also P. Ex. 3 at 15.

On or about December 8, 2014, the State Board reinstated Dr. Martin’s medical license,
subject to probation. P. Ex. 2 at | 10; see also P. Ex. 3 at 16. According to a compliance
letter, dated February 20, 2015, the State Board opined that the conditions of probation
“do not restrict or limit [Dr. Martin’s] license to practice medicine as an Orthopedic
Surgeon.” P. Ex. 3 at 16.

At the time of his license suspension, Dr. Martin was a partner with Desert Orthopaedic
Center, Ltd., an orthopedic group practice. P. Ex. 2 at § 4; see also P. Ex. 3 at 22-30.
Desert Orthopaedic Center terminated its relationship with Dr. Martin on or about
December 8, 2014. P. Ex. 2 at § 12; see also P. Ex. 3 at 17. Desert Orthopaedic Center
did not notify Medicare that Dr. Martin’s license to practice medicine had been
suspended. P. Ex. 2 at 49; see also P. Ex. 3 at 17.

On or about February 24, 2015, Dr. Martin applied for individual Medicare billing
privileges under his own name and for group privileges under the name A.S. Martin
Orthopedics, P.C. P. Ex. 2 at § 13; see also P. Ex. 3 at 42-51. In these applications,

Dr. Martin disclosed that his Nevada medical license had been suspended and reinstated
subject to a probationary period of 24 months. P. Ex. 2 at J 13; see also P. Ex. 3 at 38.
In letters dated April 24, 2015, Noridian Healthcare Solutions (Noridian), a Medicare
administrative contractor, notified Dr. Martin that his enrollment applications were
approved. P. Ex. 2 at § 14; see also P. Ex. 3 at 31, 40.

Ina letter dated August 5, 2015, Noridian informed Dr. Martin that his Medicare billing
privileges were being revoked effective September 4, 2015, pursuant to 42 C.F.R.

§ 424.535(a)(9), based on his failure to report timely the suspension of his Nevada
medical license. P. Ex. 3 at 5. In addition, Noridian barred Dr. Martin from re-enrolling
in the Medicare program for one year. P. Ex. 3 at 6. On or about August 12, 2015, Dr.
Martin requested reconsideration. P. Ex. 3 at 8, 13. By letter dated December 30, 2015,
Noridian issued an unfavorable reconsidered determination reaffirming the initial
determination to revoke Dr. Martin’s Medicare billing privileges. P. Ex. 3 at 53-55.

Petitioner, through counsel, submitted a hearing request dated January 27, 2016, whic
was received February 5, 2016. The case was initially assigned to Administrative Law
Judge Scott Anderson, but effective July 15, 2016, the case was reassigned to me. Judge
Anderson issued an Acknowledgement and Pre-Hearing Order (Order) dated February
11, 2016, which directed each party to file a pre-hearing exchange consisting of a brief
and any supporting documents, and also set forth the deadlines for those filings. Order
44. The Order also explained that the parties should submit written direct testimony for

any witnesses in lieu of in-person direct testimony. Order § 8. Finally, the Order
explained that a hearing would only be necessary for the purpose of cross-examination of
witnesses. Order §§ 9, 10.

In response to the Order, CMS filed a brief (CMS Br.), exhibits (CMS Exs. 1-7), anda
response to Petitioner’s brief (CMS Resp.). Petitioner, through counsel, filed a brief
(P. Br.) and three exhibits (P. Exs. 1-3). Neither party objected to any proposed exhibit.
I admit the parties’ exhibits into the record.

CMS represented that it did not intend to present any witness testimony; accordingly, it
did not submit the written direct testimony of any witness. Petitioner submitted the
written direct testimony of Dr. Martin. P. Ex. 2. CMS did not ask to cross-examine Dr.
Martin. The parties cross-moved for summary judgment. However, as an in-person
hearing to cross-examine witnesses is not necessary, I decide this case based on the
written record. I therefore deny the parties’ cross-motions for summary judgment.

II. Issues

Whether CMS had a legal basis to revoke Dr. Martin’s Medicare enrollment and billing
privileges because Dr. Martin failed to report timely to CMS an adverse legal action.

If CMS had a legal basis to revoke Dr. Martin’s Medicare enrollment and billing
privileges, whether the revocation was effective 30 days from the date of the revocation
notice or the date Dr. Martin’s medical license was suspended.

Ill. Jurisdiction

I have jurisdiction to decide this case. 42 C.F.R. §§ 498.3(b)(17), 498.5())(2); see also
42 U.S.C. § 1395cc(j)(8).

IV. Findings of Fact, Conclusions of Law, and Analysis!

As a physician, Dr. Martin is a “supplier” for purposes of the Medicare program. See
42 U.S.C. § 1395x(d); 42 C.F.R. §§ 400.202 (definition of supplier), 410.20(b)(1). In
order to participate in the Medicare program as a supplier, individuals must meet certain
criteria to enroll and receive billing privileges. 42 C.F.R. §§ 424.505, 424.510. CMS
may revoke the enrollment and billing privileges of a supplier for any reason stated in
42 C.F.R. § 424.535. When CMS revokes a supplier’s Medicare billing privileges, CMS
establishes a reenrollment bar for a period ranging from one to three years. 42 C.F.R.
§ 424.535(c). Generally, a revocation becomes effective 30 days after CMS mails the

' My numbered findings of fact and conclusions of law appear in bold and italics.
initial determination revoking Medicare billing privileges, but if the revocation is based
on a license suspension or revocation, the revocation is effective with the date of such
license suspension or revocation. 42 C.F.R. § 424.535(g).

I. Dr. Martin’s license to practice medicine in the State of Nevada was suspended
September 23, 2014; however, Dr. Martin did not report the suspension to the
Medicare contractor until on or about February 24, 2015.

Dr. Martin does not dispute that his license to practice medicine was suspended from
September 23, 2014, to December 8, 2014. P. Br. at 2; see also P. Ex. 2 at J§ 6, 10.
Further, he does not dispute that he first reported to Noridian that his license had been
suspended on or about February 24, 2015, which is more than 30 days after the date his
license was suspended. P. Br. at 3; see also P. Ex. 2 at § 13. As discussed in the
following section, Dr. Martin’s reasons for failing to report timely the suspension of his
license do not provide a basis for reversing the revocation of his Medicare enrollment and
billing privileges.

2. CMS had a legal basis to revoke Dr. Martin’s Medicare enrollment and billing
privileges pursuant to 42 C.F.R. § 424.535(a)(9) because Dr. Martin failed to
report an adverse legal action within 30 days as is required by 42 C.F.R.

§ 424.516(d)(1)(ii) .

CMS may revoke a currently enrolled supplier’s billing privileges in the following
circumstance, among others:

The . . . supplier did not comply with the reporting requirements
specified in 42 C.F.R. § 424.516(d)(1)(ii) and (iii) of this subpart.

42 C.F.R. § 424.535(a)(9). In turn, section 424.516(d)(1)(ii) requires physicians and
other practitioners to report to their Medicare contractor, within 30 days, any “adverse
legal action.” Section 424.502 defines a “final adverse action” to include “[s]uspension
... of a license to provide health care by any State licensing authority.” 42 C.F.R.

§ 424.502.

It is true that that the regulations do not separately define the phrase “any adverse legal
action” as used in 42 C.F.R. § 424.516(d)(1)(ii). However, if anything, the phrase “any
adverse legal action” in section 424.516(d)(1)(ii) is broader than the term “final adverse
action,” as defined in section 424.502, because the word “any” can encompass all adverse
legal actions, not just final adverse actions. See Akram A. Ismail, DAB No. 2429 at 10-
11 (2011) (concluding that the plain language of the phrase “any adverse legal action” in
42 C.F.R. § 424.516(d)(1)(ii) requires the reporting of a license suspension, even if under
appeal). Further, in the present case, Dr. Martin has not argued that the suspension of his
icense to practice medicine in Nevada was not an “adverse legal action” or that he was
under no duty to report the suspension to Noridian. Instead, he argues, in essence, that
is failure to report the suspension should be excused.

Dr. Martin admits that he did not report his license suspension within 30 days. However,
e contends that he was unable to report timely because, during the 30 days following the
suspension, he was admitted to an inpatient rehabilitation program that restricted him
from outside contact. P. Ex. 2 at 4 8. He further asserts that he assumed that the
credentialing department of his former practice group would (and did) report on his
behalf. P. Ex. 2 at 99. Neither of these circumstances relieves Dr. Martin of his duty to
report under the regulation.

First, although Dr. Martin suggests that he was an inpatient at all times during the 30 days
immediately following his license suspension, the documents he submitted do not fully
bear this out. In particular, the facility that treated Dr. Martin issued a verification letter
stating that he was admitted to the facility on October 5, 2014, and was discharged on
November 7, 2014. P. Ex. 3 at 14. There is no evidence to suggest that he was admitted
to any other facility at an earlier date. Thus, there is no evidence that Dr. Martin was
admitted as an inpatient until 12 days following his license suspension. Therefore, I am
not persuaded that it was impossible for Dr. Martin to have reported his license
suspension within the required time frame.” Moreover, even after his release from
inpatient treatment, Dr. Martin did not immediately report to Noridian that his license had
been suspended and explain why the report was filed beyond the 30-day deadline.

Second, Dr. Martin’s assumption that his former practice group would notify Noridian on
his behalf does not relieve him of the duty to report. I am aware of no authority that
would permit Dr. Martin to avoid responsibility for his failure to report by shifting
responsibility to an agent or employee. See George E. Anderson, M.D., DAB CR4631 at
12 (2016). Indeed, the regulations compel a contrary conclusion. Section
424.516(d)(1)(ii) of the regulations imposes the duty to report adverse legal actions on
the affected physician independent of the reporting responsibility of any organization
with which the physician may be affiliated. The regulation provides, “[p]hysicians,
nonphysician practitioners and physician and nonphysician practitioner organizations
must report the following reportable events to their Medicare contractor... .” 42 C.F.R.
§ 424.516(d) (emphasis added); see also Gulf South Med.& Surgical Inst., & Kenner
Dermatology Clinic, Inc., DAB No. 2400 (2011) (corporate entities as well as their
physician owner had a duty to report). Because the regulation requires both physicians

> Although I need not and do not reach the issue here, it is not clear that the regulations
contemplate that incapacity would relieve a physician of the duty to report. See, e.g.,
Phyllis Barson, M.D., DAB CR2510 at 7 (2012) (stating that “[t]here are no exceptions to
the requirement to report”).
and physician organizations to report adverse legal actions, Dr. Martin was required to
report his license suspension whether or not his former practice group fulfilled its duty to
report.

Apparently, neither Dr. Martin nor his former practice group was aware of the duty to
report his license suspension within 30 days. See P. Ex. 2 at § 14; see also P. Ex. 3 at 17.
However, a party’s misunderstanding or ignorance of the regulation is not a defense. See
Emmanuel Brown, M.D. & Simeon K. Obeng, M.D., DAB CR2145 at 6 (2010).

Dr. Martin failed to notify Noridian within 30 days following the suspension of his license
to practice medicine in Nevada. Therefore, I conclude that CMS had a legal basis to revoke
Dr. Martin’s enrollment and billing privileges under 42 C.F.R. § 424.535(a)(9).

3. Dr. Martin’s arguments in equity are not a basis to reverse the revocation of his
Medicare enrollment and billing privileges.

Dr. Martin points out that he fully disclosed that his license to practice medicine had been
temporarily suspended when he filed his enrollment applications on or about February
24, 2015, and that Noridian approved those applications on April 24, 2015, with a
retroactive effective date of February 9, 2015. P. Ex. 2 at § 13, 14; see also P. Ex. 3 at
31, 40. Petitioner argues that Noridian approved Dr. Martin’s enrollment applications
after the opportunity to evaluate fully the circumstances of his license suspension. On
these facts, Petitioner argues that CMS exercised its discretion to approve Dr. Martin’s
Medicare enrollment applications in April 2015 and should be foreclosed from later
exercising its discretion to revoke Dr. Martin’s enrollment in August 2015 based on facts
that were apparent at the time the enrollment applications were approved. P. Br. at 5.

Petitioner’s argument assumes that it was apparent on the face of Dr. Martin’s enrollment
applications that grounds for revoking his Medicare enrollment and billing privileges
existed. The argument further assumes that, in approving the enrollment applications,
Noridian decided that revocation on those grounds was not warranted. I do not agree
with these assumptions. What was apparent from Dr. Martin’s enrollment applications
was that his license to practice medicine in Nevada had been suspended and that the
suspension had later been lifted. The enrollment applications provided no information
indicating whether Dr. Martin had previously reported his license suspension to Noridian.
Significantly, the regulatory bases that authorize a Medicare administrative contractor to
deny an enrollment application under 42 C.F.R. § 424.530 do not parallel in all instances
the bases for revocation under 42 C.F.R. § 424.535. Relevant here, the failure to report
an adverse action during a prior enrollment period is not a basis to deny enrollment under
42 C.F.R. § 424.530. See Dana Marks, M.D., DAB CR4616 at 5 (2016). Thus,

Noridian’s actions approving Dr. Martin’s enrollment applications are not a basis to infer
that Noridian had even considered, at that point, whether Dr. Martin had failed to report
his earlier license suspension.*

Petitioner argues that the enrollment applications provided Noridian with sufficient
information to determine whether Dr. Martin had violated the requirement to report
adverse actions within 30 days. P. Br. at 5. Petitioner argues, in essence, that it was
unreasonable that Noridian did not make a determination on this point until
approximately six months after the effective date it approved for Dr. Martin’s enrollment
applications. Jd. I find this argument unpersuasive. Nothing in the regulations
authorizes me to invalidate a revocation based on the amount of time it took CMS or its
contractor to investigate the basis for the revocation. The only issue before me is whether
there is a legal basis for the revocation.

Petitioner argues that Dr. Martin relied on the approval of his enrollment applications by
treating Medicare beneficiaries, for whose care he will not be reimbursed as a result of
the revocation of his enrollment. P. Br. at 5. This argument implicitly relies on the
doctrine of equitable estoppel, i.e., that CMS should be estopped from revoking Dr.
Martin’s Medicare enrollment because he relied to his detriment on Noridian’s earlier
approval of his enrollment applications. Whether the government can ever be estopped
from enforcing valid regulations based on the misrepresentations of government
employees or their agents is highly questionable. See Heckler v. Cmty. Health Servs. of
Crawford Cnty., 467 U.S. 51, 63 (1984); Schweiker v. Hansen, 450 U.S. 785 (1981). Yet,
even if estoppel could be asserted against CMS under some set of circumstances, it would
not lie here. An administrative law judge is not “authorized to provide equitable relief by
reimbursing or enrolling a supplier who does not meet statutory or regulatory
requirements.” US Ultrasound, DAB No. 2302 at 8 (2010).

Moreover, to the extent Petitioner argues that revocation of Dr. Martin’s Medicare
enrollment and billing privileges is inequitable under the circumstances presented,
CMS’s discretionary act to revoke a provider or supplier is not subject to review based on
equity or mitigating circumstances. Letantia Bussell, M.D., DAB No. 2196 at 13 (2008).
Rather, “the right to review of CMS’s determination by an [administrative law judge]
serves to determine whether CMS has the authority to revoke [the provider’s or
supplier’s] Medicare billing privileges, not to substitute the [administrative law judge’s]
discretion about whether to revoke.” Jd. (emphasis original). Once CMS establishes a
legal basis on which to proceed with a revocation, then the CMS determination to revoke

3 Tnote, additionally, that CMS instructs contractors, such as Noridian, to process
enrollment applications within specific time frames, and that the applicable processing
requirements primarily involve verifying the accuracy of the entries submitted rather than
reviewing the supplier for historical compliance. See Medicare Program Integrity
Manual §§ 15.6, 15.7.
becomes a permissible exercise of discretion, which I am not permitted to review. See id.
at 10; see also Abdul Razzaque Ahmed, M.D., DAB No. 2261 at 19 (2009), aff'd, Ahmed
v. Sebelius, 710 F. Supp. 2nd 167 (D. Mass. 2010) (if CMS establishes the regulatory
elements necessary for revocation, an administrative law judge may not substitute his or
her “discretion for that of CMS in determining whether revocation is appropriate under
the circumstances”).

4. Ido not disturb CMS’s determination that Dr. Martin’s Medicare enrollment
and billing privileges were revoked effective September 4, 2015, because even if
revocation had occurred earlier, Dr. Martin would nevertheless be barred from
applying for re-enrollment until at least September 4, 2016.

Petitioner argues that his Medicare enrollment and billing privileges should be revoked, if
at all, as of September 23, 2014, the date his license was suspended. P. Br. at 6. CMS
argues that Noridian correctly set the effective date as September 4, 2015 (i.e. 30 days
after the date of notice). CMS Resp. at 3 n.3; see also P. Ex. 3 at 5.

As an initial matter, it is not clear to me that I have authority to change the effective date
on which CMS revoked a provider or supplier’s Medicare enrollment. * The regulation at
42 C.F.R. § 498.3(b) does not include the effective date of revocation among the list of
“initial determinations” that are subject to my review. However, I need not reach this
issue, nor decide whether the effective date of Dr. Martin’s revocation should be
changed, because these issues have no practical effect on the outcome of this case.

This is because when Noridian revoked Dr. Martin’s Medicare enrollment and billing
privileges, it imposed a one-year re-enrollment bar. P. Ex. 3 at 6. The applicable
regulation, at section 424.535(c)(1) provides:

The re-enrollment bar begins 30 days after CMS or its contractor
mails notice of the revocation and lasts a minimum of | year, but not
greater than 3 years, depending on the severity of the basis for
revocation.

Thus, even if the effective date of revocation were changed in Dr. Martin’s case, the re-
enrollment bar did not begin to run until 30 days after the date of the WPS notice, that is
on September 4, 2015. Thus, the earliest Dr. Martin is eligible to apply for re-enrollment

* In interpreting 42 C.F.R. § 1001.2002(b), a provision similar to 42 C.F.R. § 424.535(g),
the Departmental Appeals Board and administrative law judges of the Civil Remedies
Division have long held that they lack authority to change the effective date of an
exclusion imposed by the Office of Inspector General pursuant to section 1128 of the
Social Security Act. See, e.g., Shaikh M. Hasan, M.D., DAB No. 2648 at 7-13 (2015)
(and cases discussed therein).

is September 4, 2016. Moreover, I am without authority to direct that Dr. Martin be re-
enrolled in Medicare at any point before he submits a new application for enrollment
which is approved by CMS or its contractor. 42 C.F.R. § 424.535(d)(1); see also

42 CFR. § 424.520(d)(1).

V. Conclusion

1 affirm CMS’s revocation of Petitioner’s Medicare enrollment and billing privileges.

/s/
Leslie A. Weyn
Administrative Law Judge