Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Mara Lynne Hall Groth,

(OI File No. H-14-43054-9),
Petitioner,

v.

The Inspector General.

Docket No. C-15-2709
Decision No. CR4353

Date: October 21, 2015

DECISION

Petitioner, Mara Lynne Hall Groth, was licensed as a registered nurse in the State of
Arizona until the Arizona State Board of Nursing (State Board) revoked her license.
Pursuant to section 1128(b)(4) of the Social Security Act (Act), the Inspector General
(I.G.) has excluded her from participation in Medicare, Medicaid, and all federal health
care programs until she regains her Arizona nursing license. Petitioner now appeals the
exclusion.

For the reasons set forth below, I find that the Arizona licensing authority revoked
Petitioner’s nursing license for reasons bearing on her professional competence and
performance, so the I.G. has appropriately excluded her from program participation.

I. Background
Petitioner, who is pro se, was first licensed as a registered nurse in 1998. I.G. (Exhibit)

(Ex.) 2 at 2. On or about March 13, 2012, the State Board “received an anonymous
complaint alleging that [Petitioner] ‘drinks and uses drugs every day.’” I.G. Ex. 2 at 2.
The complainant also alleged that Petitioner had been arrested for driving under the
influence (DUI). I.G. Ex. 2 at 2. On or about July 5, 2012, the Vice President of Clinical
Operations at North Valley Surgical Center, Petitioner’s employer, reported a suspicion
that Petitioner had a drinking problem, and informed the State Board that Petitioner had
multiple absences and did not follow company policy for reporting absences. I.G. Ex. 2
at 2. The State Board then undertook an investigation, which revealed the following
information that was included in its findings of fact, as summarized below:

e Petitioner had been convicted of misdemeanor DUI on October 13,
2006, and did not report that she had been charged with DUI to the
State Board within 10 days of her arrest;

e Petitioner was arrested on January 3, 2009, for assault and criminal
damage, and did not report these charges to the State Board within
10 days of her arrest;'

e Petitioner was charged with two felony counts relating to an alleged
aggravated DUI on March 25, 2011, after being involved in an
accident with personal injury. Petitioner’s 11-year-old daughter was
in Petitioner’s vehicle during the accident, at which time Petitioner
was found to have had a blood alcohol level of 0.199 g/dL.
Petitioner did not report that she had been charged with aggravated
DUI to the State Board;

e Petitioner, on or about April 26, 2012, answered “No” to a question
on an employment application asking if she had been guilty of a
misdemeanor or felony, and she failed to reveal a previously used
last name on the same application. In that application, she denied
having been terminated or asked to resign from previous
employment, but the State Board found that at the time of the
application, she had been terminated from at least three previous
jobs;

e Petitioner was diagnosed with alcohol abuse by Banner Behavior
Health, and was also diagnosed with alcohol dependence by Calvary
Recovery Center. Petitioner had a history of several admissions for
treatment and detoxification related to alcohol abuse;

' The State Board acknowledged that the assault charge was dismissed, and that a March
2009 conviction for criminal damage was set aside on August 15, 2012. I.G. Ex. 2 at 4.
e Petitioner admitted to a medical provider that she consumed two
bottles of wine on a daily basis.

1G. Ex. 2 at 3-6. The State Board, in its January 30, 2013 order, determined that
Petitioner had committed “unprofessional conduct” and placed her on probation for a
period of five years. I.G. Ex. 2. The State Board’s imposition of probation included
numerous requirements, which as will be explained below, were not fulfilled. As a result,
the State Board, citing “unprofessional conduct,” subsequently revoked Petitioner’s
nursing license effective 30 days from service of its September 23, 2014 order. I.G. Ex.
3.

In an April 30, 2015 letter, the I.G. advised Petitioner that she was excluded from
participation in Medicare, Medicaid, and all federal health care programs because her
license to provide health care in the State of Arizona was revoked, suspended, or
otherwise lost or was surrendered while a formal disciplinary proceeding, bearing on her
professional competence, professional performance, or financial integrity, was pending
before the state licensing authority. The letter explained that section 1128(b)(4) of the
Act authorizes the exclusion. I.G. Ex. | at 1. Petitioner timely requested review.

The I.G. submitted his brief (I.G. Br.) and three exhibits (I.G. Exs. 1-3). Petitioner filed a
brief (P. Br.) which included three attachments. The I.G. also filed a Reply Brief. In the
absence of any objection, I admit into evidence I.G. Exs. 1-3.

Administrative Law Judge Joseph Grow directed the parties to indicate in their briefs
whether an in-person hearing would be necessary, and, if so, to “describe the testimony”
it wishes to present, the names of the witnesses it would call, and a summary of each
witness’ proposed testimony.” Neither party indicates that an in-person hearing is
necessary, and neither party has listed any witnesses. This case was subsequently
assigned to me on September 23, 2015.

II. Controlling Statutes and Regulations

The Act authorizes the Secretary of Health and Human Services to exclude from program
participation an individual whose license to provide health care “has been revoked or
suspended by any State licensing authority” for reasons bearing on the individual’s
“professional competence, professional performance, or financial integrity.” Act

§ 1128(b)(4)(A); see also 42 C.F.R. § 1001.501.

> Judge Grow also directed the parties to each complete and submit a “short form brief.”
Order and Schedule for Filing Briefs and Documentary Evidence (July 9, 2015).
An exclusion based on section 1128(b)(4) of the Act is discretionary. If the I.G. exercises
his discretion to proceed with the sanction, then the mandatory minimum period of
exclusion to be imposed under section 1128(b)(4) of the Act “shall not be less than the
period during which the individual’s or entity’s license to provide health care is revoked,
suspended, or surrendered .. . .” Act § 1128(c)(3)(E) (42 U.S.C. § 1320a-7(c)(3)(E)).
Regulatory language at 42 C.F.R. § 1001.501(b)(1) implements the statutory provision.
Although an exclusion based on section 1128(b)(4) of the Act is discretionary, the I.G.’s
decision to exercise his discretion and proceed with the sanction is not subject to review.
Donna Rogers, DAB No. 2381 (2011); Keith Michael Everman, D.C., DAB No. 1880
(2003); Sheldon Stein, M.D., DAB No. 1301 (1992); 42 C.F.R. § 1005.4(c)(5).

The State Board has the authority to regulate and control the practice of nursing in that
state pursuant to A.R.S. §§ 32-1606, 1663, and 1664. The State Board has authority to
impose disciplinary sanctions when a registered nurse violates the Nurse Practice Act,
ARS. §§ 32-1601 through 1667.

III. Discussion

1. The IG. had a legal basis to exclude Petitioner from
participation in Medicare, Medicaid, and all federal health
care programs because the Arizona State Board of Nursing
revoked Petitioner’s nursing license for reasons bearing on
her professional competence or performance.*

In its initial Findings of Fact, Conclusions of Law, and Order, the State Board adopted
the findings of its administrative law judge, who concluded that, under state law,
Petitioner had committed unprofessional conduct. I.G. Ex. 2 at 7-8. In its Order, the
State Board imposed numerous conditions of probation that were tailored to address
Petitioner’s alcohol abuse. I.G. Ex. 2. The conditions of probation required the
following, in pertinent part:

e Schedule an evaluation with a State Board-approved psychologist
(Ph.D.) with expertise in substance abuse and complete the
evaluation within 60 days of the effective date of the order;

e Enroll in a State Board-acceptable Nurse Recovery Group within
seven days of the effective date of the order;

> T make this one finding of fact/conclusion of law.
e Participate at least two/three times weekly in Alcoholics
Anonymous/Narcotics Anonymous meetings within seven days of
the effective date of the order;

e Enroll in a program that meets State Board criteria for random drug
testing within seven days of the effective date of the order;

e Abstain from the personal use of alcoholic beverages and the
personal use or possession of controlled drugs requiring a
prescription unless lawfully prescribed to Petitioner for a bona fide
illness or condition by a medical provider;

e Sign all release of information forms required by the State Board or
its designee and return within ten days;

e Appear in person or telephone for interviews with the State Board;

e Apply for renewal of license, pay the applicable fee, and otherwise
maintain qualifications to practice nursing in Arizona.

LG. Ex. 2 at 9-17. On September 19, 2014, the State Board issued new Findings of Fact
and Conclusions of Law and revoked Petitioner’s license because she failed to complete
the requirements of her probation. I.G. Ex. 3 at 1. The State Board explained, in detail,
the specific probation requirements that were not completed. I.G. Ex. 3 at 1-3.

It is not disputed that Petitioner’s nursing license has been revoked by her state licensing
authority. Thus, the first element of section 1128(b)(4) is satisfied.

The second element of section 1128(b)(4) requires that the license was revoked “for
reasons bearing on the individual’s . . . professional competence [or] professional
performance.” Petitioner argues that this prong is not met and contends that she has
never been unprofessional or had an issue with professional performance. Petitioner
further contends that she could not fulfill the probation requirements because she had
financial difficulties. P. Br. at 5.

The State Board placed Petitioner on probation due, in large part, to her alcohol abuse.

At the time probation was imposed, Petitioner had one previous DUI conviction and there
were pending felony charges for a second and aggravated DUI. I.G. Ex. 2 at 3-5.
Evidence discussed by the State Board included diagnoses of alcohol abuse and alcohol
dependence, and the State Board cited several hospital admissions for detoxification. I.G.
Ex. 2 at 5-6. Additionally, medical evidence cited by the State Board indicated that
Petitioner “admitted to drinking two bottles of wine daily for years.” I.G. Ex. 2 at 6.
Although Petitioner was given the opportunity to continue working and to retain her
nursing license pursuant to the conditions of probation, she failed to complete numerous
probation requirements.

When a license is revoked due to violations of previous conditions placed on that license,
it is appropriate to look at the underlying reasons why the license was in a probationary
status. Tracy Gates, R.N., DAB No. 1768, at 6-7 (2001), citing Roy Crosby Stark, DAB
No. 1746 (2000). The circumstances that led the State Board to previously impose the
conditions of probation can reasonably be viewed as the reasons the State Board
ultimately revoked Petitioner’s license. Stark, DAB No. 1746, at 4.

Although the State Board revoked Petitioner’s license for failing to complete the
requirements of probation, the underlying basis for the probation was heavily premised
on Petitioner’s alcohol abuse. I.G. Ex. 2 at 7-8. Substance abuse directly affects
professional competence as those terms are used in section 1128(b)(4). Gates, DAB No.
1768; Stark, DAB No. 1746. Furthermore, the State Board made a conclusion of law that
Petitioner had committed unprofessional conduct, which it noted “specifically” included
a “pattern of using or being under the influence of alcohol, drugs, or similar substance to
the extent that judgment may be impaired and nursing practice detrimentally affected.”
IG. Ex. 2 at 7-8, citing A.A.C. R4-19-403(B)(17) (2005). The Board also specifically
found that Petitioner had engaged in a “pattern of failure to maintain minimum standards
of acceptable and prevailing nursing practice.” I.G. Ex. 2 at 7-8, citing A.A.C. R4-19-
403(1) (2009). While Petitioner disagrees and believes that her use of alcohol had no
bearing on her professional competence and performance, she is mistaken. I conclude as
a matter of law that the revocation of Petitioner’s nursing license was for reasons related
to her professional competence and professional performance. This is supported by the
State Board’s findings of fact and conclusions of law, along with the violations of nursing
standards contained in the Arizona Revised Statutes and Arizona Administrative Code
that were referenced by the State Board.

While Petitioner appears to disagree with the underlying basis for the revocation of her
nursing license, the basis for that determination is not reviewable, as it is a final
adjudicated decision by another government agency. 42 C.F.R. § 1001.2007(d). I
reiterate that my authority is limited to determining whether there is a basis for exclusion,
and I have no authority to review the I.G.’s exercise of discretion. 42 C.F.R.

§ 1005.4(c)(5). The I.G. appropriately excluded Petitioner from program participation
under section 1128(b)(4)(A) of the Act.

Petitioner indicated that “‘[o]nce I get my DUI issues resolved I plan to get my Nursing
License reinstated.” P. Br. at 6. The statute requires that Petitioner’s period of exclusion
“shall not be less than the period during which [her] . . . license... is... revoked.” Act
§ 1128(c)(3)(E); see also 42 C.F.R. § 1001.501(b)(1). If Petitioner regains her Arizona
nursing license, she may be eligible for reinstatement at such time. I.G. Ex. | at 1.
IV. Conclusion

For the above reasons, I conclude that the I.G. properly excluded Petitioner from
participation in Medicare, Medicaid, and all federal health care programs for so long as
her Arizona nursing license is revoked.

/s/
Leslie C. Rogall
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
LF Medical Services of NY, P.C.,

(NPI: 1699916957; PTAN: A100001711),
Petitioner,

v.

Centers for Medicare & Medicaid Services
Docket No. C-15-2177
Decision No. CR4350
Date: October 21, 2015
DECISION

The Medicare enrollment and billing privileges of Petitioner, LF Medical Services of NY,
P.C., are revoked pursuant to 42 C.F.R. § 424.535(a)(9), effective January 7, 2015.

I. Background

National Government Services (NGS), the Medicare contractor, notified Petitioner by
letter dated December 8, 2014, that its Medicare billing privileges were being revoked
effective January 9, 2015. NGS cited 42 C.F.R. § 424.535(a)(9) as the basis for the
revocation and notified Petitioner that it was subject to a two-year reenrollment bar
pursuant to 42 C.F.R. § 424.535(c). Centers for Medicare & Medicaid Services (CMS)
Exhibit (Ex.) 1 at 8-9.

Petitioner requested reconsideration of the revocation. CMS Ex. | at 4-6. Ina
reconsideration decision dated February 23, 2015, CMS upheld the revocation, again
citing 42 C.F.R. § 424.535(a)(9) as the basis for revoking Petitioner’s billing privileges.
CMS Ex. | at 1-2.
On April 22, 2015, Petitioner timely filed a request for hearing before an administrative
law judge (ALJ). On May 15, 2015, the case was assigned to me for hearing and decision
and an Acknowledgement and Prehearing Order (Prehearing Order) was issued at my
direction.

On June 15, 2015, CMS filed a combined prehearing brief and motion for summary
judgment (CMS Br.) with CMS Exs. | through 13. On July 14, 2015, Petitioner filed a
combined prehearing brief and opposition to CMS’s motion for summary judgment

(P. Br.) with Petitioner’s Exhibits (P. Exs.) 1 and 2. On July 29, 2015, CMS filed a reply
brief (CMS Reply). No objections have been made to my consideration of CMS Exs. 1
through 13 and P. Exs. 1 and 2, and they are admitted as evidence.

II. Discussion
A. Applicable Law

Section 1831 of the Social Security Act (the Act) (42 U.S.C. § 1395j) establishes the
supplementary medical insurance benefits program for the aged and disabled known as
Medicare Part B. Administration of the Part B program is through contractors, such as
NGS. Act § 1842(a) (42 U.S.C. § 1395u(a)). Payment under the program for services
rendered to Medicare-eligible beneficiaries may only be made to eligible providers of
services and suppliers.” Act §§ 1835(a) (42 U.S.C. § 1395n(a)), 1842(h)(1) (42 U.S.C.
§ 1395u(h)(1)). Petitioner is a supplier.

The Act requires the Secretary of Health and Human Services (Secretary) to issue
regulations that establish a process for the enrollment in Medicare of providers and
suppliers, including the right to a hearing and judicial review of certain enrollment

* A “supplier” furnishes services under Medicare and includes physicians or other
practitioners and facilities that are not included within the definition of the phrase
“provider of services.” Act § 1861(d) (42 U.S.C. § 1395x(d)). A “provider of services,”
commonly shortened to “provider,” includes hospitals, critical access hospitals, skilled
nursing facilities, comprehensive outpatient rehabilitation facilities, home health
agencies, hospice programs, and a fund as described in sections 1814(g) (42 U.S.C.

§ 1395f(g)) and 1835(e) (42 U.S.C. § 1395n(e)) of the Act. Act § 1861(u) (42 U.S.C.

§ 1395x(u)). The distinction between providers and suppliers is important because they
are treated differently under the Act for some purposes.
determinations, such as revocation of enrollment and billing privileges. Act § 1866(j)
(42 USC. § 1395cc(j)). Pursuant to 42 C.F.R. § 424.505, a supplier such as Petitioner
must be enrolled in the Medicare program and be issued a billing number to have billing
privileges and to be eligible to receive payment for services rendered to a Medicare
eligible beneficiary.

Suppliers must submit complete, accurate, and truthful responses to all information
requested in the enrollment application. 42 C.F.R. § 424.510(d)(2). Pursuant to

42 CFR. §§ 424.502 and 424.510(d)(3), a supplier’s application to enroll in Medicare
must be signed by an authorized official, i.e., one with authority to bind the provider or
supplier both legally and financially. The regulation provides that the signature attests to
the accuracy of information provided in the application. The signature also attests to the
fact that the provider or supplier is aware of and agrees to abide by all applicable statutes,
regulations, and program instructions. 42 C.F.R. § 424.510(d)(3). Suppliers must meet
basic requirements depending on their type of service. 42 C.F.R. §§ 424.505, 424.516,
424.517. Suppliers are also subject to additional screening requirements depending upon
the type of service they provide. 42 C.F.R. § 424.518.

The Secretary has delegated the authority to revoke enrollment and billing privileges to
CMS. 42 C.F.R. § 424.535. CMS or its Medicare contractor may revoke an enrolled
supplier’s Medicare enrollment and billing privileges and supplier agreement for any of
the reasons listed in 42 C.F.R. § 424.535. Pursuant to 42 C.F.R. § 424.535(a)(1), CMS
may revoke a supplier’s enrollment and billing privileges if the supplier is determined not
to be in compliance with enrollment requirements. Relevant here, revocation is also
authorized under 42 C.F.R. § 424.535(a)(9) when a provider or supplier fails to comply
with the reporting requirements in 42 C.F.R. § 424.516(d)(1)(ii) and (iii). Those
reporting requirements provide that physicians, nonphysician practitioners, and physician
and nonphysician practitioner organizations must report any adverse legal action or
change in practice location to their Medicare contractor within 30 days. 42 C.F.R.

§ 424.516(d)(1)(ii), (iii).

If CMS revokes a supplier’s Medicare billing privileges, the revocation becomes
effective 30 days after CMS or one of its contractors mails the revocation notice to the
supplier, subject to some exceptions not applicable in this case. 42 C.F.R. § 424.535(g).
After a supplier’s Medicare enrollment and billing privileges are revoked, the supplier is
barred from reenrolling in the Medicare program for one to three years. 42 C.F.R.

§ 424.535(c).

A supplier whose enrollment and billing privileges have been revoked may request
reconsideration and review as provided by 42 C.F.R. pt. 498. 42 C.F.R. § 424.545(a). A
supplier submits a written request for reconsideration to CMS or its contractor. 42 C.F.R.
§ 498.22(a). CMS or its contractor must give notice of its reconsidered determination to
the supplier, giving the reasons for its determination and specifying the conditions or

requirements the supplier failed to meet, and the right to an ALJ hearing. 42 C.F R.

§ 498.25. If the decision on reconsideration is unfavorable to the supplier, the supplier
has the right to request a hearing by an ALJ and further review by the Departmental
Appeals Board (the Board). Act § 1866(j)(8) (42 U.S.C. § 1395cc(j)(8)); 42 C.F.R.

§§ 424.545, 498.3(b)(17), 498.5. A hearing on the record, also known as an oral hearing,
is required under the Act. Crestview Parke Care Ctr. v. Thompson, 373 F.3d 743, 748-51
(6th Cir. 2004). The supplier bears the burden to demonstrate that it meets enrollment
requirements with documents and records. 42 C.F.R. § 424.545(c).

B. Issues
Whether summary judgment is appropriate; and

Whether there was a basis for revocation of Petitioner’s billing privileges and
enrollment in Medicare.

C. Findings of Fact, Conclusions of Law, and Analysis

My conclusions of law are set forth in bold text followed by my findings of fact and
analysis.

1. Summary judgment is appropriate.

CMS has requested summary judgment. As noted above, a supplier whose enrollment
has been revoked has a right to a hearing and judicial review, and a hearing on the record
is required under the Act. Act §§ 205(b), 1866 (h)(1), (j); 42 C-F.R. §§ 498.3(b)(1), (5),
(6), (8), (15), (17), 498.5; Crestview, 373 F.3d at 748-51. A party may waive appearance
at an oral hearing but must do so affirmatively in writing. 42 C.F.R. § 498.66. In this
case, Petitioner has not waived the right to oral hearing or otherwise consented to a
decision based only upon the documentary evidence or pleadings. Accordingly,
disposition on the written record alone is not permissible, unless CMS’s motion for
summary judgment has merit.

Summary judgment is not automatic upon request but is limited to certain specific
conditions. The Secretary’s regulations at 42 C.F.R. pt. 498 that establish the procedure
to be followed in adjudicating Petitioner’s case do not establish a summary judgment
procedure or recognize such a procedure. However, the Board has long accepted that
summary judgment is an acceptable procedural device in cases adjudicated pursuant to 42
CFR. pt. 498. See, e.g., Ill. Knights Templar Home, DAB No. 2274 at 3-4 (2009);
Garden City Med. Clinic, DAB No. 1763 (2001); Everett Rehab. & Med. Ctr., DAB No.
1628 at 3 (1997). The Board also has recognized that the Federal Rules of Civil
Procedure do not apply in administrative adjudications such as this, but the Board has
accepted that Fed. R. Civ. Pro. 56 and related cases provide useful guidance for
determining whether summary judgment is appropriate. Furthermore, a summary
judgment procedure was adopted as a matter of judicial economy within my authority to
regulate the course of proceedings and made available to the parties in the litigation of
this case by my Prehearing Order. The parties were given notice by the Prehearing Order
that summary judgment is an available procedural device and that the law as it has
developed related to Fed. R. Civ. Pro. 56 will be applied.

Summary judgment is appropriate when there is no genuine dispute as to any issue of
material fact for adjudication and/or the moving party is entitled to judgment as a matter
of law. In determining whether there are genuine issues of material fact for trial, the
reviewer must view the evidence in the light most favorable to the non-moving party,
drawing all reasonable inferences in that party’s favor. The party requesting summary
judgment bears the burden of showing that there are no genuine issues of material fact for
trial and/or that it is entitled to judgment as a matter of law. Generally, the non-movant
may not defeat an adequately supported summary judgment motion by relying upon the
denials in its pleadings or briefs but must furnish evidence of a dispute concerning a
material fact, i.e., a fact that would affect the outcome of the case if proven. Mission
Hosp. Reg’! Med. Ctr., DAB No. 2459, at 4 (2012) (and cases cited therein); Experts Are
Us, Inc., DAB No. 2452, at 4 (2012) (and cases cited therein); Senior Rehab. & Skilled
Nursing Ctr., DAB No. 2300, at 3 (2010) (and cases cited therein); see also Anderson v.
Liberty Lobby, Inc., 477 U.S. 242, 248 (1986).

The standard for deciding a case on summary judgment and an ALJ’s decision-making in
deciding a summary judgment motion differ from that used in resolving a case after a
hearing. On summary judgment, the ALJ does not make credibility determinations,
weigh the evidence, or decide which inferences to draw from the evidence, as would be
done when finding facts after a hearing on the record. Rather, on summary judgment, the
ALJ construes the evidence in a light most favorable to the non-movant and avoids
deciding which version of the facts is more likely true. Holy Cross Vill. at Notre Dame,
Inc., DAB No. 2291, at 5 (2009). The Board also has recognized that on summary
judgment it is appropriate for the ALJ to consider whether a rational trier of fact could
find that the party’s evidence would be sufficient to meet that party’s evidentiary burden.
Dumas Nursing & Rehab., L.P., DAB No. 2347, at 5 (2010). The Secretary has not
provided in 42 C.F.R. pt. 498 for the allocation of the burden of persuasion or the
quantum of evidence required to satisfy the burden. However, the Board has provided
some persuasive analysis regarding the allocation of the burden of persuasion in cases
subject to 42 C.F.R. pt. 498. Batavia Nursing & Convalescent Ctr., DAB No. 1904
(2004), aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson, 129 Fed. App’x 181
(6th Cir. 2005).

There is no genuine dispute as to any material fact pertinent to revocation under 42
CFR. § 424.535(a)(9) or the effective date of the revocation that requires a hearing. The
issues in this case raised by Petitioner related to revocation under 42 C.F.R.
§ 424.535(a)(9) are issues of law that must be resolved against Petitioner as a matter of
law. The undisputed evidence shows that there is a basis for revocation of Petitioner’s
Medicare enrollment and billing privileges. Accordingly, summary judgment is
appropriate.

2. There is a basis for revocation of Petitioner’s billing privileges
pursuant to 42 C.F.R. § 424.535(a)(9).

3. The effective date of revocation of Petitioner’s Medicare enrollment
and billing privileges is January 7, 2015.

a. Facts
The facts are not disputed and any inferences are drawn in favor of Petitioner.

In June 2009, Petitioner first applied to enroll as a Medicare supplier by completing and
submitting a CMS-855] form. Its practice location at the time of enrollment was 3057
Coney Island Avenue, Brooklyn, New York 11235. CMS Ex. 2 at 17.

On September 23, 2009, Petitioner submitted a CMS-855] to “add” a new practice
location at 52 Lorraine Street, Brooklyn, New York 11231. CMS Ex. 3 at 2,8, 19. The
CMS-855I has three check-boxes in section 4 — “change,” “add,” or “delete” — and it is
not disputed that Petitioner checked only the “add” box. CMS Ex. 3 at 19. NGS
approved the added practice location effective September 1, 2009. CMS Ex. | at 12.

On January 14, 2013, Petitioner submitted a CMS-855I form marked to “add” a new
practice location at 2174 Flatbush Avenue, Brooklyn, New York 11234. CMS Ex. 4 at 1-
2, 4-6, 18. Again, it is not disputed that Petitioner checked only the “add” box on the
CMS-855I, not the “change” or “delete” boxes. CMS Ex. 4 at 18. CMS ultimately
rejected the application after Petitioner failed to provide requested information. CMS Ex.
4 at 33-34. On August 6, 2013, Petitioner applied to “change” its practice location to the
2147 Flatbush Avenue address. On this CMS855-I, Petitioner checked only the “change”
box. CMS Ex. 5 at 1-2, 4-6, 18. NGS subsequently informed Petitioner that it had
approved the “new practice location” effective July 1, 2013. CMS Ex. | at 15.

On June 26, 2014, Petitioner applied to “add” a new practice location at 424 Lafayette
Avenue, Brooklyn, New York 11238. On this CMS-855], it is undisputed that Petitioner
checked the “add” box and not the “change” or “delete” boxes. Following the address for
the practice location, Petitioner noted “Secondary Location.” CMS Ex. 6 at 1-3, 7-8, 20.
NGS approved the “new practice location . . . added” effective July 1, 2014. CMS Ex. 1
at 19.
On September 27, 2014, a CMS contractor attempted to conduct a site verification survey
at Petitioner’s Lorraine Street practice location, but found that the building was occupied
by a candy store. CMS Exs. 7-8. On October 1, 2014, a CMS contractor attempted to
conduct a site verification survey at Petitioner’s Flatbush Avenue practice location, but
found that the building was vacant. CMS Exs. 9-10. On October 7, 2014, a CMS
contractor attempted to conduct a site verification survey at Petitioner’s Coney Island
Avenue practice location, but found that the building was vacant. CMS Exs. 9, 11.
Petitioner does not deny that it was not operating at the three locations when the site
visits were made. P. Br. at 3, P. Ex. 1-2.

By letter dated December 8, 2014, NGS notified Petitioner that its Medicare billing
privileges would be revoked effective January 9, 2015, pursuant to 42 C.F.R.

§ 424.535(a)(9) because Petitioner had failed to notify CMS within 30 days that it had
ceased operating at the Lorraine Street, Flatbush Avenue, and Coney Island Avenue
practice locations as required by 42 C.F.R. § 424.516(d)(1)(iii). CMS Ex. 1 at 8-9, 22-
23.

Petitioner admits that it only operated the Coney Island Avenue location until October
2009, the Lorraine Street location until 2013, and the Flatbush Avenue location until July
2014. P. Br. at 3; P. Ex. 1 at 2.

b. Analysis

Petitioner agreed as a condition for enrolling in Medicare to notify NGS of any “change
in practice location” within 30 days. 42 C.F.R. §§ 424.500, 424.505, 424.510,
424.516(d)(1)(ili). Section 4 of the CMS-855] enrollment application provides boxes for
providers and suppliers to check to report a change, addition, or deletion of a practice
location. CMS Ex. 3 at 19; CMS Ex. 5 at 18; CMS Ex. 6 at 20. There is no dispute that
Petitioner notified NGS each time it started practicing at a new practice location by
submitting a CMS-855I to “add” or “change” a practice location. But there is also no
dispute that Petitioner never notified NGS that it was ceasing operations at its practice
locations on Coney Island Avenue, Lorraine Street, and Flatbush Avenue by completing a
CMS-855I to alert NGS and CMS that those practice locations were no longer operating
and should be deleted. Because Petitioner failed to comply with the reporting
requirements of 42 C.F.R. § 424.516(d)(1)(iii), there is a basis for revocation of
Petitioner’s Medicare enrollment and billing privileges under 42 C.F.R. § 424.535(a)(9).

Petitioner argues that it timely notified CMS of its new practice locations, and did not
understand that it needed to “affirmatively remove practice locations” in order to comply
with the reporting requirements. P. Br. at 2; P. Ex. | at 3; P. Ex. 2 at 2. Petitioner argues
that 42 C.F.R. § 424.535(a)(9) is unconstitutionally vague and that the CMS-8551
provides inadequate instructions about how to report a change in practice location. P. Br.
at 5-10. My authority is limited to determining whether there is a basis for revocation of
Petitioner’s Medicare enrollment and billing privileges. Abdul Razzaque Ahmed, M.D.,
DAB No. 2261 at 19 (2009). I am required to follow the Act and regulations, and I have
no authority to declare statutes or regulations invalid. 1866I1CPayday.com, L.L.C., DAB
No. 2289 at 14 (2009) (noting that “[a]n ALJ is bound by applicable laws and regulations
and may not invalidate either a law or regulation on any ground”). Thus, even though I
accept for purposes of summary judgment that Petitioner’s owner and employee (P. Exs.
1,2) did not understand either the regulations or the CMS-855I, that fact is not a basis on
which I may conclude that the regulations are invalid and that Petitioner’s failure to
comply with the regulations is not a basis for revocation.

Petitioner further argues that CMS’s decision to revoke its billing privileges was
unreasonable, unjust, and an abuse of discretion, and that a two-year reenrollment bar is
excessive. P. Br. at 11-12. CMS is authorized to impose a bar to reenrollment of one to
three years. 42 C.F.R. § 424.535(c). The regulations grant Petitioner no right to review
of the CMS decision as to the appropriate period of the bar, and I have no authority to
conduct review of that issue. 42 C.F.R. § 424.545. I also have no authority to review the
exercise of discretion by CMS to revoke where there is a basis for revocation. Ahmed,
DAB No. 2261 at 19. To the extent Petitioner’s arguments are construed as a request for
equitable relief, I have no authority to grant equitable relief. US Ultrasound, DAB No.
2302 at 8 (2010) (“Neither the ALJ nor the Board is authorized to provide equitable relief
by reimbursing or enrolling a supplier who does not meet statutory or regulatory
requirements.”).

NGS notified Petitioner on December 8, 2015, that the effective date of the revocation of
Petitioner’s enrollment and billing privileges was January 9, 2015. CMS Ex. | at 8-9, 22-
23. The regulation is clear that when CMS revokes a supplier’s Medicare billing
privileges, the revocation becomes effective 30 days after CMS or one of its contractors
mails the revocation notice to the supplier, subject to some exceptions not applicable in
this case. 42 C.F.R. § 424.535(g). The thirtieth day after December 8, 2015 (the date the
letter was mailed has not been disputed) was January 7, 2015, not January 9, 2015.
Accordingly, by operation of 42 C.F.R. § 424.535(g), the effective date of revocation was
January 7, 2015, and not January 9, 2015.
III. Conclusion

For the foregoing reasons, Petitioner’s Medicare enrollment and billing privileges were
properly revoked due to noncompliance with 42 C.F.R. § 424.535(a)(9), effective January
7, 2015.

/s/
Keith W. Sickendick
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division

Natalie Galbo, R.N,
(OI File No. H-14-4-2824-9),

Petitioner,
v.

Inspector General,
U.S. Department of Health and Human Services,

Respondent.
Docket No. C-15-2139
Decision No. CR4347
Date: October 20, 2015
DECISION
Petitioner, Natalie Galbo, R.N., is excluded from participating in Medicare, Medicaid,
and all federal health care programs pursuant to section 1128(a)(2) of the Social Security
Act (Act) (42 U.S.C. § 1320a-7(a)(2)), effective March 19, 2015. Petitioner’s exclusion,

for a minimum period of five years, is required by section 1128(c)(3)(B) of the Act
(42 U.S.C. § 1320a-7(c)(3)(B)).!

' 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.
I. Background

The Inspector General (1.G.) for the Department of Health and Human Services notified
Petitioner by letter dated February 27, 2015, that she was excluded from participation in
Medicare, Medicaid, and all federal health care programs for a period of five years. The
LG. cited section 1128(a)(2) of the Act as the basis for Petitioner’s exclusion and stated
that the exclusion was based upon her conviction in the Buffalo City Court of Erie
County of the State of New York of a criminal offense related to the neglect or abuse of
patients, in connection with the delivery of a health care item or service. Attachment to
Request for Hearing at 1.

Petitioner timely requested a hearing on April 17, 2015. The case was assigned to me,
and I convened a prehearing conference by telephone, the substance of which is recorded
in my Prehearing Conference Order and Schedule for Filing Briefs and Documentary
Evidence dated June 15,2015. The I.G. filed a motion for summary judgment with a
supporting brief (I.G. Br.) and four exhibits marked I.G. Exhibits (Exs.) 1 through 4.
Petitioner filed her opposition to the I.G.’s motion (P. Br.), with three exhibits marked as
Petitioner’s exhibits (P. Exs.) 1 through 3. The LG. filed a reply brief (I.G. Reply).
There have been no objections to my consideration of I.G. Exs. 1 through 4 and P. Exs. |
through 3, and all are admitted as evidence.

II. Discussion
A. Applicable Law

Section 1128(f) of the Act (42 U.S.C. § 1320a-7(f)) establishes Petitioner’s rights to a
hearing by an administrative law judge (ALJ) and judicial review of the final action of
the Secretary of Health and Human Services (the Secretary).

Pursuant to section 1128(a)(2) of the Act, the Secretary must exclude from participation
in any federal health care program any individual convicted under federal or state law of
a criminal offense related to the neglect or abuse of a patient, in connection with the
delivery of a health care item or service, including any offense that the I.G. concludes
resulted in neglect or abuse of patients. The Secretary has promulgated regulations
implementing these provisions of the Act. 42 C.F.R. § 1001.101(b).”

> References are to the revision of the Code of Federal Regulations (C.F.R.) in effect at
the time of the I.G. action, unless otherwise indicated.
Pursuant to section 1128(i) of the Act, an individual is “convicted” of a criminal offense
when a judgment of conviction has been entered by a federal, state, or local court whether
or not an appeal is pending or the record has been expunged; or when there has been a
finding of guilt in a federal, state, or local court; or when a plea of guilty or no contest
has been accepted in a federal, state, or local court; or when an accused individual enters
a first offender program, deferred adjudication program, or other arrangement where a
judgment of conviction has been withheld. 42 U.S.C. § 1320a-7(i)(1)-(4); 42 C.F.R.

§ 1001.2.

Section 1128(c)(3)(B) of the Act provides that an exclusion imposed under section
1128(a) of the Act will be for a period of not less than five years. 42 C.F.R.

§ 1001.102(a). Pursuant to 42 C.F.R. § 1001.102(b), the period of exclusion may be
extended based on the presence of specified aggravating factors. Only if the aggravating
factors justify an exclusion of longer than five years are mitigating factors considered as a
basis for reducing the period of exclusion to no less than five years. 42 C.F.R.

§ 1001.102(c).

The standard of proof is a preponderance of the evidence, and there may be no collateral
attack of the conviction that provides the basis of the exclusion. 42 C.F.R.

§ 1001.2007(c), (d). Petitioner bears the burden of proof and the burden of 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).

B. Issues
The Secretary has by regulation limited my scope of review to two issues:

Whether the I.G. has a basis for excluding an individual or entity from
participating in Medicare, Medicaid, and all other federal health care programs;
and

Whether the length of the proposed exclusion is unreasonable.

42 CFR. § 1001.2007(a)(1). If the I.G. imposes the minimum period of exclusion
authorized for a mandatory exclusion under section 1128(a)(2 ) of the Act, then there is
no issue of whether the period of exclusion is unreasonable. 42 C.F.R.

§ 1001.2007(a)(2). The I.G. proposes to exclude Petitioner for five years, the minimum
authorized period. Therefore, the length of the proposed exclusion is not at issue.

C. Findings of Fact, Conclusions of Law, and Analysis

My conclusions of law are set forth in bold followed by the pertinent findings of fact and
analysis.
1. Petitioner timely filed her request for hearing, and I have
jurisdiction.

2. Summary judgment is appropriate in this case.

There is no dispute that Petitioner timely requested a hearing and that I have jurisdiction
pursuant to section 1128(f) of the Act and 42 C.F.R. pt. 1005.

Pursuant to section 1128(f) of the Act, a person subject to exclusion has a right to
reasonable notice and an opportunity for a hearing. The Secretary has provided by
regulation that a sanctioned party has the right to a hearing before an ALJ, and both the
sanctioned party and the I.G. have a right to participate in the hearing. 42 C.F.R.

§ 1005.2-.3. Either or both parties may choose to waive appearance at an oral hearing
and to submit only documentary evidence and written argument for my consideration.
42 C.F.R. § 1005.6(b)(5). An ALJ may also resolve a case, in whole or in part, by
summary judgment. 42 C.F.R. § 1005.4(b)(12).

Summary judgment is appropriate in an exclusion case when there are no disputed issues
of material fact and when the undisputed facts, clear and not subject to conflicting
interpretation, demonstrate that one party is entitled to judgment as a matter of law.
Tanya A. Chuoke, R.N., DAB No. 1721 (2000); David A. Barrett, DAB No. 1461 (1994);
Robert C. Greenwood, DAB No. 1423 (1993); Thelma Walley, DAB No. 1367 (1992);
Catherine L. Dodd, R.N., DAB No. 1345 (1992); John W. Foderick, M.D., DAB No.
1125 (1990). When the undisputed material facts of a case support summary judgment,
there is no need for a full evidentiary hearing, and neither party has the right to one.
Surabhan Ratanasen, M.D., DAB No. 1138 (1990); Foderick, DAB No. 1125. In
opposing a properly-supported motion for summary judgment, the nonmoving party must
show that there are material facts that remain in dispute, and that those facts either affect
the proponent’s prima facie case or might establish a defense. Garden City Med. Clinic,
DAB No. 1763 (2001); Everett Rehab. & Med. Ctr., DAB No. 1628 (1997). It is
insufficient for the nonmovant to rely upon mere allegations or denials to defeat the
motion and proceed to hearing. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247
(1986).

There are no genuine issues of material fact in dispute in this case. Petitioner does not
dispute that she was convicted within the meaning of section 1128(i) of the Act of two
criminal offenses. Petitioner argues that the conduct for which she was convicted does
not relate to abuse or neglect in connection with delivery of a health care item or service.
P. Br. at 2. Petitioner’s arguments require application of law to the undisputed facts and,
as discussed hereafter, are resolved against her. To the extent that Petitioner disputes the
facts underlying her conviction (P. Br. at 3-7; P. Ex. 1), her arguments amount to
collateral attacks on her conviction which are not permitted under 42 C.F.R.

§ 1001.2007(d). Therefore, Petitioner’s assertions of fact other than those she admitted to
as part of her plea agreement do not constitute genuine disputes of material fact that
preclude summary judgment. P. Br. at 3-7. I conclude that summary judgment is
appropriate as there are no genuine disputes as to any material facts and the I.G. prevails
as a matter of law on the issue of whether there is a basis for exclusion.

3. Petitioner’s exclusion is required by section 1128(a)(2) of the Act.
a. Facts

The material facts of this case are undisputed. On December 9, 2014, Petitioner signed a
“Plea Agreement and Colloquy” in which she agreed to having committed the offenses of
disorderly conduct. Petitioner specifically admitted as part of her plea agreement:

I admit that in the County of Erie, State of New York, with
intent to cause public inconvenience, annoyance or alarm, or
recklessly creating a risk thereof, I created a hazardous or
physically offensive condition by an act which served no
legitimate purpose, as follows: On or about and between June
11 and June 27, 2013, while I was employed as a Registered
Nurse at Highpointe and assigned to physically check on the
welfare of resident LM, a bedridden 56 year old male who
suffered from Huntington’s chorea and was totally dependent
on Highpointe staff for all of his care, I signed the Q2 check
sheet for resident LM, a record kept and maintained by
Highpointe in the regular course of business, indicating that I
had checked on resident LM when I did not.

1G. Ex. 3 at 4-5. Based on her admitted misconduct, Petitioner pleaded guilty to two
counts of disorderly conduct, violations of section 240.20(7) of the Penal Laws of the
State of New York. LG. Ex. 3 at 5. Petitioner’s guilty pleas were accepted. I.G. Ex. 2 at
6-7. Petitioner was sentenced to pay a $120 surcharge, perform 200 hours of community
service, and attend a “Scared Straight” program at a nursing facility if asked to do so.
IG. Ex. 2 at 7-8; I.G. Ex. 3 at 2; 1.G. Ex. 4.

b. Analysis

The IG. cites section 1128(a)(2) of the Act as the basis for Petitioner’s mandatory
exclusion. The statute provides:

(a) MANDATORY EXCLUSION. — The Secretary shall
exclude the following individuals and entities from
participation in any Federal health care program (as defined
in section 1128B(f)):

(2) Conviction relating to patient abuse. — Any individual or
entity that has been convicted, under Federal or State law, of
a criminal offense relating to neglect or abuse of patients in
connection with the delivery of a health care item or service.

Act § 1128(a)(2). The plain language of section 1128(a)(2) of the Act requires that the
Secretary exclude from participation in Medicare, Medicaid, and all federal health care
programs, any individual or entity: (1) convicted of a criminal offense; (2) where the
offense related to neglect or abuse of patients; and (3) where the offense is related to the
delivery of a health care item or service.

Petitioner does not contest that she was convicted of two criminal offenses within the
meaning of 1128(i) of the Act (42 U.S.C. § 1320a-7(i)). P. Br. at 2; P. Ex. 1 at 6. As
noted above, an individual is “convicted” of an offense when a plea of guilty is accepted
by a state court. Act § 1128(i)(3). Petitioner’s guilty pleas were accepted by the court.
The court issued a judgment of conviction and sentenced Petitioner for the offenses of
which she was convicted. I.G. Ex. 2 at 7-8. Accordingly, I conclude that Petitioner was
convicted of a criminal offense within the meaning of 1128(i) of the Act.

Petitioner argues that the facts the I.G. has offered regarding Petitioner’s conduct, those
contained in her plea agreement, do not tell the whole story and that if I look behind the
facts to the underlying conduct, I will see that Petitioner’s criminal offense did not
constitute abuse or neglect. Petitioner characterizes her actions as a “‘singular ministerial
act” and argues that the language in her plea agreement does not accurately reflect her
conduct. P. Br. at 4. Her conduct was neither abuse nor neglect, she contends, because:
(1) she was not assigned to provide care for resident LM; (2) she believed that the care
had been provided to the resident; (3) she was not covering up the lack of delivery of a
health care item or service; and (4) she reasonably believed the record would be corrected
at a later time. P. Br. at 5. Petitioner filed her affidavit marked and admitted as P. Ex. 1.
Petitioner argues and asserts in her affidavit that she and her attorney did not prepare the
Plea Agreement and Colloquy that she signed on December 9, 2014, and agreed to in
open court. I.G Ex. 2 at 6-7; I.G. Ex. 3. In her affidavit, Petitioner attests to facts
different than those she agreed to in her Plea Agreement and Colloquy and admitted to in
court. P. Ex. 1. Pursuant to 42 C.F.R.§ 1001.2007(d), when the I.G. excludes an
individual based on a criminal conviction, as here, “the basis of the underlying conviction
. .. is not reviewable and the individual . . . may not collaterally attack it either on
substantive or procedural grounds.” 42 C.F.R. § 1001.2007(d). Accordingly, I conclude
that in this proceeding Petitioner is bound by the facts she agreed to as part of her plea
agreement. Petitioner cannot in this proceeding create a genuine dispute as to the facts
she admitted as part of her plea or seek to have me find that her conviction was based on
incorrect facts.

Petitioner argues that her conviction of disorderly conduct did not involve abuse or
neglect. She argues that “filling out information on an internal form (the ‘Q2’) when
requested to do so by her supervisor” was neither neglect or abuse, “particularly when
Petitioner was made to believe that the aide who was responsible for providing these
services but neglected to fill in the data on the form” would make corrections at a later
date. P. Br. at 4-5. Petitioner states she did not fail to satisfy a duty of care, willfully
mistreat a patient, or fail to provide goods and services necessary to avoid harm or willful
infliction of injury. She urges that her “conduct was solely related to record keeping and
data entry. P. Br. at 5.

Section 1128 does not define either abuse or neglect. Previously, I have looked to
definitions for those terms under 42 C.F.R. § 488.301, where abuse and neglect are
defined in the context of long-term care facilities. Yvette Greaves, DAB CR1403 (2006).
I look to those definitions here as well, which is appropriate because Petitioner concedes
that she was practicing as a registered nurse and nurse manager at a nursing home when
she committed her offenses. P. Ex. | at 3-4. Abuse is “the willful infliction of injury,
unreasonable confinement, intimidation, or punishment with resulting physical harm,
pain or mental anguish.” 42 C.F.R. § 488.301. Neglect is “failure to provide goods and
services necessary to avoid physical harm, mental anguish, or mental illness.” Id.

I conclude that Petitioner pleaded guilty to acts that constitute neglect within the meaning
of section 1128(a)(2). Specifically, Petitioner admitted as part of her plea agreement that
she was “assigned to physically check on the welfare of resident LM . . . [who] was
totally dependent on Highpointe staff for all of his care.” I.G. Ex. 3 at 3-4. Petitioner
further admitted as part of her plea that she “signed the Q2 check sheet . . . indicating that
[she] had checked on resident LM when [she] did not.” I.G. Ex. 3 at 5. Petitioner was
assigned to provide care that she did not provide, and her care was necessary to avoid
harm to resident LM because the resident was totally dependent on the facility’s staff,
including Petitioner, for his wellbeing. There is a sufficient nexus between Petitioner’s
criminal offense and the neglect of the nursing home resident. Therefore, I conclude that
Petitioner was convicted of criminal offenses related to neglect of a patient because she
failed to provide a necessary care or services to avoid harm to the resident.

Petitioner also argues that her actions were not in connection with the delivery of a health
care item or service because she was not assigned to provide care for resident LM. P. Br.
at 7. Petitioner’s conduct was plainly in connection with the delivery of a health care
item or service because, as she admitted as part of her plea agreement, her conduct was
related to the performance of her duties as a nurse working in a nursing home. I.G. Ex. 3
at 5.
I conclude that Petitioner was convicted of criminal offense related to neglect of a patient
in connection with the delivery of a health care item or service. Accordingly, I conclude
that all elements of section 1128(a)(2) of the Act are met and there is a basis for
Petitioner’s exclusion. The I.G. has no discretion under the Act not to exclude Petitioner
when the elements of section 1128(a)(2) are satisfied, as they are in this case.

4. Five years is the minimum authorized period of exclusion pursuant
to section 1128(a) of the Act.

5. Petitioner’s exclusion for five years is not unreasonable as a matter
of law.

Congress established five years as the minimum period of exclusion for exclusions
pursuant to section 1128(a) of the Act. Act § 1128(c)(3)(B). Pursuant to 42 C.F.R.

§ 1001.2007(a)(2), when the I.G imposes an exclusion pursuant to section 1128(a) of the
Act for the statutory minimum period of five years, there is no issue of whether or not the
period is unreasonable. Accordingly, I conclude that Petitioner’s exclusion for a period
of five years is not unreasonable as a matter of law.

Petitioner submitted numerous performance reviews that demonstrate Petitioner’s
competence and good performance of her nursing duties. P. Ex. 2. However, I have no
authority to reduce the period of exclusion below the mandatory minimum of five years
based on Petitioner’s otherwise exemplary performance of her nursing duties. Act

§ 1128(c)(3)(B); 42 CFR. § 1001.102(a).

Exclusion is effective 20 days from the date of the I.G.’s written notice of exclusion to
the affected individual or entity. 42 C.F.R. § 1001.2002(b).

III. Conclusion

For the foregoing reasons, Petitioner is excluded from participation in Medicare,
Medicaid, and all other federal health care programs for the minimum statutory period of
five years, effective March 19, 2015.

/s/
Keith W. Sickendick
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Orthotic Prosthetic Associates Inc.,
d/b/a RJM Orthotic & Prosthetic Associates, Inc.
(PTAN: 1247220001),

Petitioner,
v.
Centers for Medicare & Medicaid Services.
Docket No. C-15-2262
Decision No. CR4336

Date: October 20, 2015

DECISION

Petitioner, Orthotic Prosthetic Associates Inc., d/b/a RJM Orthotic & Prosthetic
Associates, Inc., appeals the Centers for Medicare & Medicaid Services’ (CMS’s)
decision to revoke its Medicare enrollment and billing privileges. As explained below, I
find Petitioner was not in compliance with all Medicare requirements, and I uphold
CMS’s revocation determination. However, I modify the effective date of the revocation
from October 31, 2014 to January 4, 2015.

I. Background and Procedural History

Petitioner was enrolled in the Medicare program as a supplier of durable medical
equipment, prosthetics, orthotics and supplies (DMEPOS). By letter dated December 5,
2014, Palmetto GBA National Supplier Clearinghouse (NSC), a Medicare contractor,
notified Petitioner that it was revoking Petitioner’s Medicare supplier number retroactive
to October 31, 2014, and that Petitioner was barred from re-enrolling in the Medicare
program as a supplier for two years from this date. CMS Ex. 4, at 1. The notice letter
explained that site visits by a NSC representative on October 22 and 31, 2014, were
unsuccessful because on both attempts Petitioner’s facility was closed during its posted
hours of operation. The letter further explained that because an inspection could not be
completed, NSC could not verify Petitioner’s compliance with the supplier standards.
Accordingly, NSC determined that Petitioner was not operational to furnish Medicare
covered items and services and was in violation of 42 C.F.R. §§ 424.57(c)(7),

424 .535(a)(5)(ii), and all other supplier standards in 42 C.F.R. § 424.57(c). The notice
letter also stated that, according to NSC’s records, Petitioner was not accredited, in
violation of 42 C.F.R. § 424.57(c)(22). CMS Ex. 4, at 1-2.

Petitioner requested reconsideration. CMS Ex. 5. On February 24, 2015, a hearing
officer issued an unfavorable decision upholding the revocation, finding that Petitioner
was not in compliance with Medicare enrollment requirements, specifically Supplier
Standards 7 and 22 (42 C.F.R. § 424.57(c)(7), (22)). CMS Ex. 1, at 1-4. Petitioner then
timely requested a hearing with the Civil Remedies Division of the Departmental Appeals
Board. On May 7, 2015, I issued an Acknowledgment and Pre-Hearing Order (Order).
Pursuant to this Order, on June 8, 2015, CMS filed its pre-hearing brief and motion for
summary judgment (CMS Br.), along with five exhibits (CMS Exs. 1-5). On August 17,
2015, Petitioner filed its pre-hearing brief opposing CMS’s motion for summary
judgment and cross-moving for summary judgment (P. Br.), along with six exhibits (P.
Exs. 1-6) and the written direct testimony of its owner (Manfredi Cert.). Neither party
objected to the other’s exhibits, nor did CMS object to the written direct testimony
proffered by Petitioner, so I admit all proffered exhibits and testimony into the record.

My Order advised the parties that they must submit written direct testimony for each
proposed witness and that an in-person hearing would be necessary only if the opposing
party affirmatively requested an opportunity to cross-examine a witness. Pre-Hearing
Order §§ 8, 9; see Vandalia Park, DAB No. 1940 (2004); Pacific Regency Arvin, DAB
No. 1823, at 7-8 (2002) (holding that the use of written direct testimony for witnesses is
permissible so long as the opposing party has the opportunity to cross-examine those
witnesses). CMS did not propose any witnesses, nor did it request to cross-examine the
one witness, Petitioner’s owner, proposed by Petitioner. I find, therefore, that an in-
person hearing in this case is unnecessary, and I issue this decision on the full merits of
the written record.

II. Analysis
A. Issue

The issue in this case is whether the evidence establishes that CMS had a legitimate basis
to revoke Petitioner’s Medicare enrollment and billing privileges.
B. Findings of Fact and Conclusions of Law

1. CMS had a legitimate basis to revoke Petitioner’s Medicare enrollment
and billing privileges because a NSC inspector was not able to access
Petitioner’s location on October 22 and 31, 2014, during Petitioner’s
posted hours of operation, in violation of Supplier Standard 7.

To receive Medicare payments for items furnished to a Medicare-eligible beneficiary, a
DMEPOS supplier must have a supplier number issued by the Secretary of Health and
Human Services. Social Security Act (Act) § 1834(j)(1)(A) (42 U.S.C.

§ 1395m(j)(1)(A)). To enroll in Medicare and receive billing privileges, a DMEPOS
supplier is required to meet and maintain compliance with the 30 “supplier standards” set
forth in 42 C.F.R. § 424.57(c). In pertinent part, Supplier Standard 7 requires a
DMEPOS supplier to be in a location accessible to the public and CMS and to be
accessible and staffed during its posted hours of operation. 42 C.F.R.

§ 424.57(c)(7)(i)(B),(C).

If a DMEPOS supplier is found not to meet the standards in section 424.57(c), CMS will
revoke the supplier’s billing privileges. 42 C.F.R. § 424.57(e). Where a Medicare
contractor’s representative finds the supplier’s facility closed during its posted hours, the
supplier does not meet the regulatory requirements of section 424.57(c)(7), and CMS
may appropriately revoke the supplier’s billing privileges. See Ita Udeobong, DAB No.
2324 (2010).

In support of its revocation determination, CMS introduced the inspection report of the
NSC investigator who attempted to visit Petitioner’s location. According to the report,
the investigator attempted to visit Petitioner’s facility at approximately 11:45 a.m. on
Wednesday, October 22, 2014, and at approximately 3:55 p.m. on Friday, October 31,
2014. On both attempts, the inspector noted that the facility was closed, no staff
appeared to be present, and no signs of customer activity were present. CMS Ex. 3 at 1.
Date- and time-stamped photographs support the investigator’s observations and show
that the location’s posted hours were Monday-Friday 8:30 a.m.-4:30 p.m. CMS Ex. 3 at
2-5.

Petitioner concedes that the investigator was not able to access its location during its
posted hours of operation on October 22 and 31, 2014. Petitioner argues, however, that
its closure at those times was a “de minimis” deviation from its posted hours, not
reflective of its standard operations, and that there are reasonable explanations for the
closures. P. Br. at 6-7.

According to Petitioner, the location was inaccessible on October 22 because staff briefly
locked the front door to take a lunch break or to use the bathroom. Petitioner asserts that
its business involves meeting with customers by appointment, so it allows staff flexible
lunch periods during times when there are no scheduled appointments. Petitioner also
asserts that it is office policy for staff to lock up while using the bathroom to ensure the
safety and security of its employees, files, and inventory. P. Br. at 6-7; Manfredi Cert. at
99 7-10.

Petitioner says that it was inaccessible on October 31 because its owner allowed a staff
member to close early to spend Halloween with her children. P. Br. at 7; Manfredi Cert.
at JJ 11-13. Petitioner argues that by attempting to visit the location on Halloween, a
“widely celebrated holiday,” the investigator violated CMS’s own written protocols on
the timing of inspections. P. Br. at 7-8.

I find that Petitioner’s closures on October 22 and 31, 2014, constituted noncompliance
with Supplier Standard 7. As Petitioner admits, its location was not accessible at certain
times during its posted hours of operation on those dates. Although Petitioner argues that
it was inaccessible for only brief periods and that there were sound management
rationales for the closures, the regulations require a supplier to make whatever reasonable
arrangements are necessary to keep its business open during all of its posted hours of
operation. Ato Z DME, LLC, DAB CR1995, at 6 (2009), aff’d, Ato Z DME, LLC, DAB
No. 2303 (2010). (“A Medicare supplier differs from a strictly private business in that it
is an integral part of a publicly run program. The requirement that a supplier be open at
all times during normal business hours reflects CMS’s determination that a supplier be
available to beneficiaries to meet their needs and to alleviate their medical conditions.”).
This is true even in situations where beneficiaries do not routinely visit a supplier’s
facility. 73 Fed. Reg. 4503, 4506 (2008) (preamble to proposed rule).

Further, CMS guidance does instruct contractors not to perform site verifications on
“holidays,” without elaborating what is meant by that term. CMS Pub. 100-08, Medicare
Program Integrity Manual, Ch. 15, § 15.20.1(B). However, in the preamble to the final
tule that implemented section 424.57(c)(7)(i)(B) and (C), in response to comments
suggesting that CMS should allow facilities to temporarily close during posted hours to
account for circumstances including holidays, the drafters noted that CMS has “always
made exceptions concerning posted hours for disasters and emergencies and Federal and
State holidays.” 75 Fed. Reg. 52,629, 52,636 (2010) (emphasis added). Thus, suppliers
may be excused for closing during their posted hours of operation on federal and state
holidays, and it may not be appropriate for contractors to perform site inspections on
those days. Halloween is not a federal or state holiday, however.

Because Petitioner failed to comply with Supplier Standard 7, CMS had a legitimate basis
to revoke Petitioner’s Medicare enrollment and billing privileges. 42 C.F.R. § 424.57(e).
Failure to comply with even one supplier standard on one occasion is a sufficient basis
for revocation, so I do not address Petitioner’s purported noncompliance with Supplier
Standard 22 in order to sustain CMS’s decision to revoke. See 1866ICPayday.com, DAB
No. 2289, at 13 (2009).

2. The correct effective date for the revocation is January 4, 2015, 30 days
after the date that NSC issued the initial revocation determination.

NSC’s initial notice letter to Petitioner dated December 5, 2014, informed Petitioner that
its billing privileges were revoked effective October 31, 2014, “the date [CMS]
determined your practice location is not operational.” CMS Ex. 4 at 1. In setting
October 31, 2014, as the effective date of the revocation, CMS was apparently relying on
42 CFR. § 424.535(g), which provides in part that if CMS revokes a provider or
supplier’s billing privileges on the ground that the provider or supplier’s practice location
is not operational, the revocation is effective as of the date that CMS or its contractor
determined the provider or supplier was no longer operational. As a general rule,
however, the regulations provide that a revocation becomes effective 30 days after the
provider or supplier is sent notice of the revocation. See 42 C.F.R. §§ 424.57(e),
424.535(g). The general rule, rather than the exception present in section 424.535(g),
should govern here.

NSC’s initial notice letter explained that Petitioner had been found not operational, in
violation of 42 C.F.R. § 424.535(a)(5)(ii), as well as out of compliance with 42 C.F.R.

§ 424.57(c)(7) and (22). CMS Ex. 4 at 1-2. But the Medicare hearing officer’s
reconsidered decision dated February 24, 2015 — which is the determination before me
for review (see 42 C.F.R. § 498.5(1)(2); Neb Group of Arizona, DAB No. 2573, at 5-6;
Joy Medical Supply, DAB No. 2572, at 5) — did not conclude that Petitioner was not
operational. The hearing officer cited the definition of “operational,” but she found only
that Petitioner “has not shown compliance with supplier standard[s] 7 and 22” and she
stated that her decision was made “in accordance with Medicare guidelines, as outlined in
... 42CFR424.57.”! CMS Ex. | at 2-4.

The hearing officer’s reconsidered decision did not modify the effective date of the
revocation of Petitioner’s billing privileges. However, because the hearing officer did not
find that Petitioner’s practice location was not operational and instead found only that
Petitioner was out of compliance with the supplier standards in section 424.57, the
effective date should have been determined in accordance with section 424.57(e). Thus,
the proper effective date for the revocation of Petitioner’s billing privileges is January 4,
2015, 30 days after the date that NSC issued the initial revocation determination.

' Talso note that CMS argued before me only that the revocation was appropriate
because Petitioner violated Supplier Standards 7 and 22, not because Petitioner’s practice
location was not operational.
III. Conclusion

I sustain the revocation of Petitioner’s supplier number and billing privileges because
CMS has shown that Petitioner was not accessible and staffed on October 22 and 31,
2014, during Petitioner’s posted hours of operation, as the regulations require. However,
in accordance with 42 C.F.R. § 424.57(e), I modify the effective date of the revocation to
January 4, 2015. Petitioner is barred from re-enrolling in Medicare for two years from
this date.

/s/
Joseph Grow
Administrative Law Judge