Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
)
Therapy Management Services, Inc., )
d/b/a CompRehab, (CCN: 49-6641), ) Date: January 26, 2009
)
Petitioner, )
)
-V.- ) Docket No. C-08-301
) Decision No. CR1892
Centers for Medicare & Medicaid )
Services. )
)
DECISION

Petitioner, Therapy Management Services, Inc., d/b/a CompRehab (Petitioner or
CompRehab), provided outpatient physical therapy (OPT) services in Woodbridge,
Virginia. Until its termination on January 10, 2008, CompRehab was certified to
participate in the Medicare program. However, following a survey completed on May 23,
2007, the Centers for Medicare & Medicaid Services (CMS) terminated CompRehab’s
program participation because it failed to maintain substantial compliance with six out of
twelve conditions of participation. Petitioner here challenges its termination. CMS now
moves for summary judgment.'

' CMS filed a Brief in Support of Summary Affirmance (CMS Br.), accompanied
by 11 proposed exhibits (CMS Exs. 1-11). Petitioner, represented by Brenda M. Hunt, its
owner/administrator, did not submit a separate brief, but responded with 12 proposed
exhibits (P. Exs. 1-12). One of those exhibits, a written statement signed by
Administrator Hunt, sets forth Petitioner’s allegations of fact and legal arguments. P.

Ex. 1. CMS filed a reply brief (CMS Reply).
2

For the reasons discussed below, I find that summary judgment is appropriate. Petitioner
does not challenge CMS’s determination that it was not in substantial compliance with all
Medicare conditions of participation at the time of its survey. CMS was therefore
authorized to terminate its Medicare provider agreement.

Discussion

CMS is entitled to summary judgment because the undisputed facts
establish that CompRehab failed to maintain substantial compliance with
all Medicare conditions of participation, and CMS is therefore authorized
to terminate its program participation.”

Summary judgment is appropriate here because this case turns on a question of law and
presents no genuine dispute as to any material fact. Anderson v. Liberty Lobby, Inc., 477
U.S. 242, 247-48 (1986); Livingston Care Center v. United States Department of Health
and Human Services, 388 F.3d 168, 173 (6" Cir. 2004).

OPT services may be covered by the Medicare program if they are provided in
accordance with statutory and regulatory requirements. The Social Security Act (Act)
defines OPT services as physical therapy services furnished by, or under arrangement
with, a provider of services, clinic, rehabilitation agency or public health agency to an
individual who is under the care of a physician, and with respect to whom a physician or
qualified physical therapist has established a care plan prescribing the type, amount and
duration of services. A physician must review the plan periodically. Act § 1861(p).
Pursuant to the Act, the Secretary of Health and Human Services has, by regulation,
established additional health and safety requirements called “conditions of participation.”
Act § 1861(p)(4); 42 C.F.R. §§ 485.701; 488.1.

A “condition of participation” represents a broad category of OPT services. Each
condition is contained in a single regulation, which is divided into subparts called
standards. 42 C.F.R. Part 485. Compliance with a condition of participation is
determined by the manner and degree to which the provider satisfies the standards within
the condition. 42 C.F.R. §§ 488.1; 488.26(b). If deficiencies are of such character as to
“substantially limit the provider’s .. . capacity to furnish adequate care or which
adversely affect the health and safety of patients,” the provider is not in compliance with
conditions of participation. 42 C.F.R. § 488.24(b).

? | make this one finding of fact/conclusion of law.
3

CMS, acting on behalf of the Secretary, may terminate a provider agreement based on the
provider’s failure to comply with the provisions of section 1861 or its failure to comply
with all applicable conditions of participation. Act § 1866(b)(2); 42 C.F.R. § 489.53(a);
Community Home Health, DAB No. 2134, at 12 (2007). To monitor compliance, CMS
contracts with state agencies that conduct periodic surveys. Act § 1864(a); 42 C.F.R.

§ 488.20. For facilities that are not skilled nursing facilities (SNFs), nursing facilities
(NFs), or home health agencies, the State Agency must survey “as frequently as necessary
to ascertain compliance. ...” 42 C.F.R. § 488.20(b)(1).

Here, CompRehab apparently was not surveyed for more than eleven years — from
February 1996 until May 2007. P. Ex. 1. On May 23, 2007, the Virginia Center for
Quality Health Care Services and Consumer Protection (State Agency) completed a re-
certification survey.’ CMS Ex. 2. Based on the survey findings, CMS has determined
that CompRehab was not in substantial compliance with six conditions: 42 C.F.R.

§ 485.709 (administrative management); 42 C.F.R. § 485.717 (rehabilitation program);
42 C.F.R. § 485.721 (clinical records); 42 C.F.R. § 485.725 (infection control); 42 C.F.R.
§ 485.727 (disaster preparedness); and 42 C.F.R. § 485.729 (program evaluation). CMS
Exs. 1, 11.4

> At the time of the survey, CompRehab was dually enrolled in the Medicare
program as both a comprehensive outpatient rehabilitation facility (CORF) and an OPT
provider, but, following the survey, it withdrew its CORF participation and continued
only as an OPT provider. CMS Ex. 3, at 1, 2 (Thomas-Naarden Decl. Jf 4, 6, 8); CMS
Ex. 10, at 2.

+ Among other deficiencies, CompRehab lacked by-laws; it had failed to disclose
a change in ownership and control; it had no budget plan or cost report, no staff job
descriptions, no performance evaluations, no evidence of continuing education. Policies
were neither dated nor signed; no evidence suggested physician or physical therapist
involvement in their development; CompRehab did not have a group of professional
personnel to develop and review policies. The physician named in the emergency
services policy was no longer on staff, and staff were instructed to call 911 in the event of
an emergency if the patient’s private physician could not be reached. Assessments for
social and vocational adjustment were not conducted and those services were not
provided. CompRehab had no contracts for outside services. Clinical records, stored
offsite, could not be obtained in the Administrator’s absence. Some clinical records were
stored in an unlocked closet. Cleaning solutions were stored under a sink near the
children’s treatment area. Necessary repairs had not been made. The facility had no
designated containers for contaminated linens or dressings; it had no process for

(continued...)
4

Petitioner has not challenged the May 2007 survey findings. Its hearing request
acknowledges that “there were deficiencies at the time of the survey.” Nor do
Petitioner’s subsequent submissions suggest any dispute with the survey findings. In fact,
in her written statement, Administrator Hunt does not allege that CompRehab achieved
substantial compliance any earlier than “the time of the expected re-visit of the survey
team in early December 2008.” P. Ex. 1.

When a provider’s Medicare participation is terminated because of alleged
noncompliance, “the critical date for establishing compliance is the survey date, not the
subsequent effective date of the termination.” Carmel Convalescent Hospital, DAB No.
1584, at 12 (1996); Rosewood Living Center, DAB No. 2019, at 11 (2006). A provider’s
efforts to bring itself into compliance after the date of the resurvey is “completely
irrelevant to the facility’s appeal of [CMS’s] determination to terminate.” Carmel, DAB
No. 1584, at 13.

I recognize that the petitioner in Carmel was a long-term care facility (SNF or NF). I also
recognize that care should be exercised when applying to other types of providers
decisions involving a long-term care facility’s participation in the Medicare program.
Although long-term care facilities are “providers” and generally subject to the same
procedural rules as other providers, the rules are not identical. Compare, e.g., 42 C.F.R.

§ 488.28 with 42 C.F.R. § 488.402. Special rules allow for the ongoing certification of
noncompliant SNFs and NFs. 42 C.F.R. §§ 488.24; 488.330. In applying a SNF or NF
ruling to another type of provider, it is therefore important to examine the underlying
reasoning to assure that the ruling is not based solely on rules peculiar to long-term care,
but instead is based on principles applicable to all providers.

4(...continued)
identifying patients with open sores. It had no process for identifying, investigating,
preventing and controlling causes of patient infection. To clean equipment, staff used
germicidal wipes with an expiration date more than two years earlier. No evidence
showed that the carpeting had been cleaned, and the facility had no cleaning schedule.
No provisions were in effect to insure that the premises were maintained free of rodent
and insect infestation. The facility’s 11-year-old disaster plan did not designate how,
where, or by whom patients would be relocated. No evidence showed staff drills or
training in disaster preparedness. CMS Ex. 8. Remarkably, the State Agency must have
determined that these deficiencies neither jeopardized patient health and safety nor
seriously limited CompRehab’s capacity to render adequate care, because it allowed the
facility to continue its participation contingent on its submission of an acceptable plan of
correction. CMS Ex. 6. And CMS subsequently acquiesced in that determination. CMS
Exs. 7, 10; see, 42 C.F.R. § 488.28(a) and (b).
5

The Departmental Appeals Board’s reasoning in Carmel applies here. The Board noted
that a provider’s participation is determined by means of a state survey. Inasmuch as a
facility entering the program may participate no earlier than the date on which the onsite
survey establishes compliance — here, the Board cited 42 C.F.R. § 489.13(a), a rule
applicable to all providers — its participation is terminated based on the findings at the
time of the survey. The regulations require CMS to rely on the survey agency’s finding
which “necessarily relate to the status of the facility as of the date of the survey.” The
Board also pointed out that, as a practical matter, relying on a date after the survey “could
cause a never-ending cycle of resurveys based on unsubstantiated claims of compliance

y a facility as of the later date.” Carmel, DAB No. 1584, at 13.

Because the parties agree that CompRehab was not in substantial compliance with all
conditions of participation on the date of the survey, CMS had the authority to terminate
its Medicare participation, and is entitled to summary judgment.

n reaching this decision, I recognize CMS’s discretion to afford providers an opportunity
to correct deficiencies prior to termination. See 42 C.F.R. § 488.28 (A deficient provider
may continue to participate only if the facility has “submitted an acceptable plan of
correction for achieving compliance within a reasonable time.”) Here, CMS afforded
Petitioner an opportunity to correct. CMS Exs. 6, 7, 10. But, because CMS is not
required to afford a provider the opportunity to correct a condition-level deficiency before
terminating its program participation, Petitioner’s assertion that it took corrective action
prior to the termination date is irrelevant. Community Home Health, DAB No. 2134, at
4; Excelsior Health Care Services, Inc., DAB No. 1529, at 6-7 (1995).

Finally, I note that, although Petitioner submitted two plans of correction (a plan and a
revised plan), neither the State Agency nor CMS found them acceptable, so CompRehab
was not afforded a follow-up survey. CMS Exs. 1, 8,9, 11. Petitioner bases this appeal
on CMS’s refusal to accept its Plan of Correction, arguing that it could have demonstrated
its substantial compliance during a follow-up survey. But, notwithstanding the
considerable time the parties have dedicated to the merits of CMS’s determination to
reject CompRehab’s plan of correction, that determination is wholly within CMS’s
discretion and I simply have no authority to review it

° Even though CMS has defended, on the merits, its determination to reject the
plans of correction and to decline a follow-up survey, its brief also argues that, based on
the cited deficiencies, “CMS may immediately terminate participation and had no
obligation to solicit a plan of correction or grant a reasonable period in which to correct
the deficiencies.” (Citing 42 C.F.R. §§ 488.24; 488.28.) CMS Br. at 10-11. Further,

(continued...)
6

A provider dissatisfied with an initial determination — which includes the termination of a
provider agreement in accordance with section 489.53 — may request a hearing, and
hearings are conducted in accordance with procedures set forth in 42 C.F.R. Part 498. 42
C.F.R. §§ 498.5; 489.53(e). Only initial determinations are appealable. The regulations
list actions that are initial determinations and thus subject to appeal. The determination to
reject a provider’s plan of correction is not listed as an initial determination and is
therefore not reviewable in this forum. 42 C.F.R. § 498.3(b); On-Call Nursing of Alaska,
DAB CR 1142, at 3-4; see also, HRT Laboratory, Inc., DAB No. 2118, at 11 (2007)
(same reasoning applied to a clinical laboratory); Hermina Traeye Memorial Nursing
Home, DAB No. 1810, at 13 (2002) (In affirming the termination of a SNF, “ALJ
properly concluded that he lacked authority to adjudicate the question of whether [CMS]
abused its discretion in deciding to reject the POC.” )

Conclusion

Because the uncontroverted evidence establishes that, at the time of its May 2007 survey,

CompRehab was not in substantial compliance with Medicare conditions of participation,
CMS was authorized to terminate its provider agreement. I therefore grant CMS’s motion
for summary judgement.

/s/
Carolyn Cozad Hughes
Administrative Law Judge

5(...continued)
CMS argues that its rejection of CompRehab’s plan of correction is not reviewable. CMS
Br. at 11-12. Thus, Petitioner had notice of these ultimately dispositive arguments.


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: } Date: January 23, 2009

Kim J. Rayborn, }

) Docket No. C-08-581

Petitioner, ) Decision No. CR1891
)
v. )
)
The Inspector General. )
a )

DECISION

Petitioner, Kim J. Rayborn, is excluded from participation in Medicare, Medicaid, and all
federal health care programs pursuant to section 1128(a)(2) of the Social Security Act
(the Act) (42 U.S.C. § 1320a-7(a)(2)), effective June 19, 2008, for the minimum statutory
period of five years.'

I. Background

The Inspector General (1.G.) notified Petitioner by letter dated May 30, 2008, that she was
being excluded from participation in Medicare, Medicaid, and all federal health care
programs for five years pursuant to section 1128(a)(2) of the Act. The I.G. cited as the
basis for Petitioner’s exclusion her conviction in the 27th Judicial District, Laurel
District, Division Il, Commonwealth of Kentucky, of a criminal offense related to neglect
or abuse of patients in connection with the delivery of a health care item or service.

' 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.
2

Petitioner requested a hearing by letter dated June 27, 2008. The case was assigned to me
on July 23, 2008. I held a prehearing conference in the case on August 19, 2008, the
substance of which is memorialized in my Order of that date. During the conference,
Petitioner declined to waive her right to an oral hearing, and the I.G. requested the
opportunity to file a motion for summary judgment prior to further case development.
Petitioner’s objection to proceeding on summary judgment prior to further case
development was overruled and a briefing schedule was set. On October 3, 2008, the I.G.
filed its motion for summary judgment, supporting brief (I.G. Brief) and exhibits (I.G.
Ex.) | through 5. Petitioner filed its opposition to the I.G. motion for summary judgment
(P. Brief) with exhibits (P. Ex.) 1 through 3 on December 2, 2008. CMS filed a reply
rief on December 17, 2008 (CMS Reply). No objection has been made to my
consideration of any of the offered exhibits and I.G. Exs. 1 through 5 and P. Exs. 1
through 3 are admitted as evidence.

II. Discussion
A. Findings of Fact

The following findings of fact are based upon the uncontested and undisputed assertions
of fact in the parties’ pleadings and the exhibits submitted.

1. On November 13, 2007, Petitioner pled guilty to one count of a violation of KY.
REV. STAT. § 209.990(4), a Class A misdemeanor, in the 27th Judicial District,
Laurel District, Division I, Commonwealth of Kentucky. I.G. Ex. 5.

2. Petitioner’s guilty plea was accepted on November 13, 2007, and she was
sentenced to “12 months to be diverted for a period of one year, with no time to
serve,” on certain specified conditions, and she was barred for one year from
providing direct caring of vulnerable adults. I.G. Ex. 5.

3. KY. REV. STAT. § 209.990(4) provides that “[a]ny person who recklessly abuses or
neglects an adult is guilty of a Class A misdemeanor.”

4. Petitioner agreed in her plea agreement that on or about August 1, 2006, she
“neglected ...a mentally retarded cancer patient, by failing to adequately monitor
her pain medication prescription.” I.G. Ex. 4, at 4.
3

5. Petitioner does not dispute that on or about August 1, 2006, when she neglected
the mentally retarded cancer patient, she was a caretaker and case manager at New
Foundations, a facility for the care of individuals with disabilities and that the
cancer patient was a resident at New Foundations and subject to Petitioner’s care.
LG. Brief at 3; P. Brief at 2.

6. On November 25, 2008, an Agreed Order was entered on the docket of the 27th
Judicial District, Laurel District, Division I, Commonwealth of Kentucky, that
provided that the charge against Petitioner was “diverted and dismissed” and “shall
not constitute a criminal conviction.” P. Ex. 1, at 1.

B. Conclusions of Law

1. Petitioner’s request for hearing was timely and I have jurisdiction.
2. Summary judgment is appropriate.
3. Petitioner was convicted within the meaning of section 1128(i) (42 U.S.C.

§ 1320a-7(i)) of the Act.

4. Petitioner’s conviction is related to the neglect of a patient in connection with the
delivery of a health care item or service within the meaning of section 1128(a)(2)
of the Act.

5. Petitioner’s exclusion is mandated by section 1128(a)(2) of the Act.

6. A five-year exclusion is mandatory pursuant to section 1128(c)(3)(B) (42 U.S.C.
§ 1320a-7(c)(3)(B)) of the Act.

7. Exclusion is effective 20 days from the date of the notice of exclusion. 42 C.F.R.
§ 1001.2002(b).

C. Applicable Law
Petitioner’s right to a hearing by an administrative law judge (ALJ) and judicial review of

the final action of the Secretary of Health and Human Services (Secretary) is provided by
section 1128(f) of the Act (42 U.S.C. § 1320a-7(f)).
4

Pursuant to section 1128(a)(2) of the Act, the Secretary must exclude from participation
in the Medicare and Medicaid programs “(a)ny 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.” One is
convicted of a criminal offense when a judgment of conviction is entered against an
individual or entity by a state or federal court, regardless of whether there is an appeal
pending or the judgment of conviction or other record is ultimately expunged; or when
there is a finding of guilt; or when a plea of guilty or no contest is accepted; or when the
individual or entity enters a first offender, deferred adjudication, or similar arrangement
where a judgment of conviction is withheld. Act § 1128(i).

Section 1128(c)(3)(B) of the Act provides that an exclusion imposed under section
1128(a) of the Act shall be for a minimum period of five years.

An excluded entity is entitled to reasonable notice and an opportunity for hearing under
section 205(b) of the Act. 42 U.S.C. § 1320a-7(f)(2).

D. Issues

The Secretary has by regulation limited my scope of review to two issues in a case where
exclusion is based on section 1128(a)(2) of the Act:

1. Whether there is a basis for the imposition of the exclusion; and
2. Whether the length of the exclusion is unreasonable.

42 C.F.R. § 1001.2007(a)(1). The I.G. has excluded Petitioner for the minimum
mandatory period in this case and the only issue for my consideration is whether there is a
basis for the imposition of the exclusion.

E. Analysis
1. Summary judgment is appropriate.

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 right to hearing before an ALJ is
accorded to a sanctioned party by 42 C.F.R. § 1005.2, and the rights of both the
sanctioned party and the I.G. to participate in a hearing are specified in 42 C.F.R.

§ 1005.3. 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.
5

§ 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 and no hearing
is required where either: there is no genuine dispute of material fact and the only
questions that must be decided involve application of law to the undisputed facts; or, the
moving party must prevail as a matter of law even if all disputed facts are resolved in
favor of the party against whom the motion is made. A party opposing summary
judgment must allege facts which, if true, would refute the facts relied upon by the
moving party. E.g., Fed. R. Civ. P. 56(c); Garden City Medical Clinic, DAB No. 1763
(2001); Everett Rehabilitation and Medical Center, DAB No. 1628, at 3 (1997) (in-
person hearing required where non-movant shows there are material facts in dispute that
require testimony); Thelma Walley, DAB No. 1367 (1992); see also New Millennium
CMHC, Inc., DAB CR672 (2000); New Life Plus Center, CMHC, DAB CR700 (2000).

Contrary to the assertion of Petitioner, there are no genuine issues of material fact in
dispute. Petitioner does not dispute that she was convicted of neglecting a patient in her
care. Rather, she argues that her criminal conviction no longer constitutes a criminal
conviction (P. Brief at 2-3), that the I.G. should be bound by her plea agreement (P. Brief
at 3), that her criminal conduct did not involve “the delivery of a healthcare item or
service” within the meaning of section 1128(a)(2) (P. Brief at 3-4), that summary
judgment should be denied because she deserves a hearing, and that Petitioner has been
deprived of due process. The issue of whether Petitioner’s criminal conduct involved the
delivery of a health care item or service appears, at first blush, to be a fact issue.
However, as discussed hereafter, Petitioner’s argument is that the statutory language does
not cover an offense involving the “nondelivery” or a failure to deliver a healthcare item
or service. P. Brief at 3-4. The facts necessary to my decision are either admitted or not
disputed, resolution of the issues involves application of law to undisputed facts or
interpretation of law, and summary judgment is appropriate.

2. Petitioner was convicted within the meaning of section 1128(i) of the
Act.

Petitioner argues that she no longer has a conviction within the meaning of section
1128(a) of the Act because an order was issued by the Kentucky trial court that provided
that the charge against Petitioner was “diverted and dismissed” and “shall not constitute a
criminal conviction.” P. Ex. 1, at 1; P. Brief at 2-3. Petitioner’s argument is not
persuasive. A person is “convicted” for purposes of sections 1128(a) and (b): (1) when a
judgment of conviction is entered by a state, federal, or local court, even though an appeal
may still be pending or the record of the conviction has been expunged; (2) when there
has been a finding of guilt by a court; (3) when a plea of guilt or no contest is accepted by
a court; or (4) when a judgment of conviction is withheld under a first offender, deferred
6

adjudication, or other arrangement. Act § 1128(i); Henry L. Gupton, DAB No. 2058
(2007), and ruling on reconsideration, Ruling No. 2007-1 (2007). Federal law, not state
law, provides the definition for “conviction” in this case. Travers v. Shalala, 20 F.3d
993, 996 (9th Cir. 1994).

Petitioner does not dispute that she pled guilty and her guilty plea was accepted by the
Kentucky court. Therefore, she was convicted within the meaning of sections 1128(a)
and 1128(i) of the Act. The fact that the Kentucky trial court subsequently expunged the
record is not controlling in a case involving an exclusion pursuant to section 1128(a) or
(b) of the Act.?

3. Petitioner’s plea agreement does not protect her from mandatory
exclusion pursuant to section 1128(a)(2) of the Act.

The criminal complaint against Petitioner was signed and sworn by Agent John
Dudinskie, of the Medicaid Fraud & Abuse Control Division, Commonwealth of
Kentucky, Office of the Attorney General. I.G. Ex. 3; P. Ex. 2. Petitioner argues that
Agent Dudinskie was “an agent of Medicaid and thus the Federal Government is bound to
the one year exclusion of [Petitioner] from the care of adults as stated in the Plea
Agreement.” P. Brief at 3. Petitioner asserts that Agent Dudinskie was an agent for
Medicaid in negotiating Petitioner’s plea agreement. P. Brief at 3.

Even if I accept for purposes of summary judgment that Agent Dudinskie was involved in
negotiating the plea agreement with Petitioner, Petitioner’s argument is meritless. Agent
Dudinskie’s business card reflects that he was an employee of the Commonwealth of
Kentucky, not the United States (P. Ex. 2); Medicaid is a program administered by the
state, not the federal government; Petitioner was prosecuted by the Commonwealth of
Kentucky, not the federal government (I.G. Exs. 3-5; P. Ex. 1); and Petitioner’s plea
agreement was with the Commonwealth of Kentucky, not the United States (I.G. Ex. 4, at
4). There is no evidence that suggests that federal agents had any involvement in the

? Petitioner did not object to the admissibility of I.G. Exs. 3 through 5, and
Petitioner offered P. Ex. 1, all documents related to her conviction. However, based upon
KY. REV. STAT. § 533.258(3), Petitioner notes that she does not consent “to the use of
pretrial diversion records . . . against her here.” P. Brief at 2. If the Kentucky statute has
any application in this proceeding, I conclude that Petitioner waived the application of the
provision of the Kentucky statute or constructively consented to the admission of any and
all records related to her conviction by requesting a hearing, subject only to objections
based upon authenticity and relevance of the evidence.
7

investigation or prosecution of Petitioner, there is no evidence that any representative of
the United States was involved in Petitioner’s plea agreement, and there is no evidence
that the United States was a party to Petitioner’s plea agreement. Petitioner argues that
plea agreements must be interpreted according to contract principles and that prosecutors
cannot breach plea agreements. P. Brief at 3. While the general rules Petitioner states
may be correct, Petitioner nevertheless cannot prevail on this theory as a matter of law
because there is no evidence from which to draw an inference that the federal government
was a party to Petitioner’s plea agreement. Because the United States was not a party to
Petitioner’s plea agreement, its agents are not bound by the agreement terms.

Petitioner’s plea agreement provided that the court could impose a one-year ban on
Petitioner taking direct care of vulnerable adults. I.G. Ex. 4, at 4. Her plea agreement
said nothing about the status of any license to deliver health care issued by the
Commonwealth of Kentucky. Petitioner’s plea agreement also included no provision
related to her participation in Medicare, Medicaid, or other federal health care programs.
Not only is Petitioner’s plea agreement silent about her license and participation,
Petitioner cites no authority for the proposition that the court by which she was convicted
had any authority to accept a plea agreement that included such provisions.

The I.G. argues that Petitioner’s exclusion was mandatory pursuant to section 1128(a)(2)
of the Act for a minimum period of five years and the I.G. had no discretion to do
otherwise. I.G. Reply at 4. I concur with the I.G.’s interpretation. If Petitioner’s
conviction meets the requirements of section 1128(a)(2), then Congress mandated her
exclusion for the minimum period of five years. The I.G., the Secretary, and I have no
discretion to do otherwise, and Petitioner has cited no authority for the proposition that
the provisions of a plea agreement, even if negotiated with an agent of the United States,
could affect the mandate of Congress.

4. Petitioner’s criminal conduct of neglecting a patient by failing to
monitor the patient’s pain medication prescription was a failure to
deliver a health care item or service and is within the scope of section
1128(a)(2) of the Act.

Petitioner argues that her criminal conduct did not involve the delivery of a health care
item or service; rather, it involved the “non-delivery” of an item or service. P. Brief at 3.
This argument verges on being frivolous. Petitioner admitted by her guilty plea that she
neglected “a mentally retarded cancer patient by failing to adequately monitor her pain
medication prescription.” I.G. Ex. 4, at 4. Petitioner thus admitted that the cancer patient
was her patient, that she had some duty to monitor her patient’s pain medication, and that
she failed or neglected to monitor the pain medication prescription as she was required to
do. Petitioner cannot now allege before me that the cancer patient was not her patient or
that she had no duty or obligation to deliver the healthcare service of administering and
monitoring the patient’s pain medication because collateral attack of her conviction is
prohibited. 42 C.F.R. § 1001.2007(d). Similarly, Petitioner cannot now allege new facts,
i.e. that the basis for the conviction was failure to deliver pain medication. Petitioner
admitted by her plea that she failed to deliver the health care service of monitoring her
patient’s pain medication prescription and the evidence shows that she was convicted for
that conduct. Accordingly, I conclude that the elements of section 1128(a)(2) of the Act
are satisfied and that Petitioner’s exclusion is mandatory.’

Petitioner also argues that the evidence does not show that Petitioner “received Federal
funds either through Medicare or Medicaid,” and that her exclusion is not mandatory but
should be permissive under section 1128(b) of the Act because her’s is a minor crime.

P. Brief at 3-4. Petitioner’s arguments are not persuasive. Section 1128(a)(2) of the Act
requires the exclusion from participation in federal health care programs of any individual
or entity (1) convicted under state or federal law, (2) of a criminal offense relating to
neglect or abuse of a patient, (3) in connection with the delivery of a health care item or
service. Section 1128(a)(2) does not include an element that the individual or entity to be
excluded either received or claimed payment of funds from a federal source. 42 C.F.R.

§ 1001.101(b). Section 1128(a)(2) does not include an element that requires the
conviction be for a felony rather than a misdemeanor offense. Section 1128(a)(2) also
does not require that the patient neglected or abused be Medicare or Medicaid-eligible.
Petitioner was convicted by a state court of a criminal offense of neglect of a patient by
failure to monitor pain medication. The undisputed facts satisfy the elements of section
1128(a)(2) of the Act, and there is a basis for Petitioner’s mandatory exclusion.

5. Petitioner has not been deprived of due process.

Petitioner argues that summary judgment should be denied because Petitioner deserves
the right to a hearing “to assert that the exclusion imposed against her here is a violation
of her Due Process Rights under the Fifth and Fourteenth Amendment of the United
States Constitution.” P. Brief at 4. She asserts that the I.G. action violates her
substantive and procedural due process rights to enter the type of employment she
chooses. P. Brief at 4.

> Even if the conduct for which Petitioner was convicted was her failure to give
medication, Petitioner has cited no authority to support her argument that such neglect is
not within the scope of section 1128(a)(2).
9

In this case, Petitioner has been accorded her due process right to notice and to ALJ
review. Summary judgment is appropriate in this case and no hearing is required to

satisfy Petitioner’s right to procedural

ue process for the reasons already discussed. The

correspondence forwarding this decision to Petitioner advises of her further due process

rights. Furthermore, the federal courts
procedures amount to a deprivation of

ave rejected claims that the Secretary’s exclusion
ue process, finding no constitutionally-protected

property or liberty interests. Rodabaugh v. Sullivan, 943 F.2d 855 (8th Cir. 1991);
Lavapies v. Bowen, 883 F.2d 465 (6th Cir. 1989); Hillman Rehabilitation Center v. U.S.

Dept. of Health and Human Services,

0. 98-3789 (GEB), slip op. at 16, 1999 WL

34813783, at *16 (D.N.J. May 13, 1999); Travers v. Sullivan, 801 F.Supp. 394, 404-05
(E.D. Wash. 1992), aff’d, Travers v. Shalala, 20 F.3d 993 (9th Cir. 1994). Finally, I note

that Petitioner’s exclusion does not pro

ibit her from engaging in any employment;

rather, it precludes her from participation in Medicare, Medicaid, and all federal health
care programs and payment for her services through those programs.

6. Pursuant to section 1128(c)(3)(B) of the Act, the minimum period of

exclusion under section

1128(a) is five years.

The minimum period of exclusion pursuant to section 1128(a) of the Act is five years as
mandated by section 1128(c)(3)(B). I have found there is a basis for Petitioner’s
exclusion pursuant to section 1128(a)(2), and the minimum period of exclusion is thus

five years.

Ill. Conclusion

There is a basis for exclusion and five years is the minimum period of exclusion

authorized by law.

/s/

Keith W. Sickendick
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
)
Catherine R. Kinnunen, ) Date: January 14, 2009

)
Petitioner, )
)

-Vv.- ) Docket No. C-08-577

) Decision No. CR1889
The Inspector General. )
)

DECISION

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

I. Procedural Background

Petitioner pro se Catherine R. Kinnunen was employed as a caregiver at The Seaside
House, Seaside, Oregon, in 2005 and 2006. The Seaside House is an assisted living
facility and some of its residents are Medicaid beneficiaries. From February 2005 until
January 2006, Petitioner forged checks on the personal bank accounts of at least four
residents of Seaside House, three of whom were Medicaid beneficiaries.

This activity came to the attention of Seaside House administrators, who in February 2006
reported it to local authorities. Petitioner was arrested and questioned and at first denied
wrongdoing. Her denials notwithstanding, Petitioner and her appointed attorney reached
a plea agreement with the Clatsop County District Attorney and on October 26, 2006,
Petitioner appeared with counsel in the Circuit Court for Clatsop County, State of
Oregon, and pleaded nolo contendere to four misdemeanor counts of Forgery in the
Second Degree, in violation of OR. REV. STAT. § 165.007. The Circuit Court entered its
2

Judgment and sentence on November 13, 2006: Petitioner was placed on two years’
probation, and was ordered to pay restitution in the sum of $5051, fees of $405, and
assessments of $268.

On August 31, 2007, the I.G. attempted to notify Petitioner that she was to be excluded
pursuant to the terms of section 1128(a)(1) of the Act for the mandatory minimum period
of five years. Although the precise circumstances are not clear, the record suggests that
Petitioner’s move from Oregon to North Dakota prevented her prompt receipt of the
LG.’s August 31, 2007 letter, and the I.G. sent Petitioner another copy to her current
address under separate cover dated April 21, 2008. Petitioner timely sought review of the
1.G.’s action by her pro se letter dated June 23, 2008.

I convened a telephonic prehearing conference on August 18, 2008, pursuant to 42 C.F.R.
§ 1005.6, in order to discuss procedures for addressing the case. By Order of that date, I
established a schedule for the submission of documents and briefs. All briefing is now
complete, and the record in this case is closed under the circumstances, findings, and
conclusions set out in my Order of December 11, 2008.

The evidentiary record on which I decide the issues before me contains seven exhibits, all
proffered by the I.G. and marked I.G. Exhibits 1-7 (1.G. Exs. 1-7). Petitioner proffered no
exhibits of her own and did not object to the I.G.’s proffer. In the absence of objection, I

admit I.G. Exs. 1-7.

II. Issues

The issues before me are limited to those set out at 42 C.F.R. § 1001.2007(a)(1). In the
context of this record, they are:

1. Whether the I.G. has a basis for excluding Petitioner from participating in
Medicare, Medicaid, and all other federal health care programs pursuant to
section 1128(a)(1) of the Act; and

2. Whether the proposed five-year period of exclusion is unreasonable.

Both issues must be resolved in favor of the I.G.’s position. Because her predicate
conviction has been established, section 1128(a)(1) of the Act mandates Petitioner’s
exclusion. A five-year period of exclusion is reasonable as a matter of law, since it is the
minimum period established by section 1128(c)(3)(B) of the Act, 42 U.S.C. § 1320a-
7(c)(3)(B).
Ill. Controlling Statutes and Regulations

Section 1128(a)(1) of the Act, 42 U.S.C. § 1320a-7(a)(1), requires the mandatory
exclusion from participation in Medicare, Medicaid, and all other federal health care
programs of any “individual or entity that has been convicted of a criminal offense related
to the delivery of an item or service under title X VIII or under any State health care
program.” The terms of section 1128(a)(1) are restated in regulatory language at 42
C.F.R. § 1001.101(a). This statutory provision makes no distinction between felony
convictions and misdemeanor convictions as predicates for mandatory exclusion.

The Act defines “conviction” as including those circumstances “when a judgment of
conviction has been entered against the individual... bya... State... court, regardless
of... whether the judgment of conviction or other record relating to criminal conduct has
been expunged,” section 1128(i)(1) of the Act; “when there has been a finding of guilt
against the individual... bya... State... court,” section 1128(i)(2) of the Act; or
“when a plea of guilty or nolo contendere by the individual ... has been accepted bya...
State... court,” section 1128(i)(3) of the Act. 42 U.S.C. § 1320a-7(i)(1)-(3). These
definitions are repeated at 42 C.F.R. § 1001.2.

An exclusion based in section 1128(a)(1) is mandatory and the I.G. must impose it for a
minimum period of five years. Section 1128(c)(3)(B) of the Act, 42 U.S.C. § 1320a-
7(c)(3)(B). The regulatory language of 42 C.F.R. § 1001.102(a) affirms the statutory
provision.

IV. Findings and Conclusions
I find and conclude as follows:

1. On her pleas of nolo contendere on October 26, 2006, in the Circuit Court for Clatsop
County, State of Oregon, Petitioner Catherine R. Kinnunen was found guilty of four
counts of the criminal offense of Forgery in the Second Degree, in violation of OR. REV.
STAT. § 165.007. I.G. Exs. 3, 4, 6.

2. The accepted pleas of nolo contendere, the finding of guilt, and the judgment of
conviction described above constitute a “conviction” within the meaning of sections
1128(a)(1) and 1128(i)(1), 1128(4)(2), and 1128(i)(3) of the Act, and 42 C.F.R. § 1001.2.

3. A nexus and a common-sense connection exist between Petitioner’s conviction, as
noted above in Findings | and 2 above, and the delivery of an item or service under a
State health care program. I.G. Exs. 4,5, 6, 7. Berton Siegel, D.O., DAB No. 1467
(1994).
4

4. By reason of Petitioner’s conviction, a basis exists for the I.G.’s determination to
exclude Petitioner from participation in Medicare, Medicaid, and all other federal health
care programs, pursuant to section 1128(a)(1) of the Act.

5. Because the five-year period of Petitioner’s exclusion is the mandatory minimum
period provided by law, it is not unreasonable. Section 1128(c)(3)(B) of the Act; 42
C.F.R. §§ 1001.102(a) and 1001.2007(a)(2).

6. There are no disputed issues of material fact and summary disposition is
appropriate in this matter. Michael J. Rosen, M.D., DAB No. 2096 (2007); Thelma
Walley, DAB No. 1367 (1992); 42 C.F.R. § 1005.4(b)(12).

V. Discussion

The essential elements necessary to support an exclusion based on section 1128(a)(1) of
the Act are: (1) the individual to be excluded must have been convicted of a criminal
offense; and (2) the criminal offense must have been related to the delivery of an item or
service under title XVIII of the Act (Medicare) or any state health care program. Tamara
Brown, DAB No. 2195 (2008); Thelma Walley, DAB No. 1367; Boris Lipovsky, M.D.,
DAB No. 1363 (1992). These two essential elements are fully established in the record
before me.

The first essential element is conclusively established by the Circuit Court records, which
include the Defendant’s Petition to Enter Plea, by which Petitioner, her counsel, and the
prosecuting attorney negotiated Petitioner’s nolo contendere pleas (I.G. Ex. 3), the
original charging document in the prosecution, the Complaint (I.G. Ex. 4), and the Circuit
Court’s Judgment, by which the disposition of the prosecution was recorded (I.G. Ex. 6).
The I.G. has proved the first essential element.

The second essential element — the nexus or common-sense connection to the delivery of
an item or service under a protected health care program — is present when a caregiver or
administrator, acting in a setting where care is being provided by that person or under that
person’s supervision, steals from the person or persons being cared for. One particularly
cogent statement of the notion appears in Kim Anita Fifer, DAB CR1016 (2003). While
that case involved an exclusion based on section 1128(a)(3) of the Act, its rationale fits
this section 1128(a)(1) exclusion perfectly:

A nursing facility must rely on the honesty and integrity of its employees in
order to provide necessary nursing care and housekeeping services. Here,
because she held positions of trust, Petitioner had access to personal
information on nursing home residents. She violated that trust and
victimized those individuals that she was supposed to be serving. Her
5

actions are no different than those of any nursing facility employee using
his/her position to rob or otherwise exploit vulnerable facility residents.

Kim Anita Fifer, DAB CR1016, at 4.

Section 1128(a)(1) applies only in the context of a protected program, while section
1128(a)(3) is not so restricted. Here, three of the four residents victimized by Petitioner
were Medicaid beneficiaries. I.G. Ex. 7. Petitioner gained access to her victims’
checkbooks during the course of her employment as one of their caregivers. I.G. Ex. 5.
There is ample support for my finding that the required nexus or common-sense
connection exists when private property is converted by criminal means or stolen from
Medicare or Medicaid beneficiaries. Andrew L. Branch, DAB CR1359 (2005); Tenisha
Taylor, a/k/a Tenisha Carter, DAB CR1132 (2004); Dorothy A. Woodrum, DAB CR956
(2002); Roberta E. Miller, DAB CR367 (1995); Teri L. Gregory, DAB CR336 (1994);
Gary Gregory, DAB CR274 (1993); Jerry L. Edmonson, DAB CR59 (1989). The I.G.
has proved the second essential element.

Petitioner’s pro se defense to the proposed exclusion is not developed in depth, but the
core of it is that she proclaims her innocence of crime and denies the truth of the charges,
the competence of her appointed attorney, the wisdom and soundness of her pleas, the
validity of the judgment of conviction in the Circuit Court, and the fundamental fairness
of the proceedings that led to her conviction. In the interests of that fundamental fairness,
it may be best to set out her position in her own words:

I pleaded nolo-contendere, because of the stress I endured for almost a
year, some think I got a good deal, what kinda deal, can’t do what I know
and do good - have a fine of over $6,000.00 dollars, had to do things I
shouldn’t have, I have a record, and medicaid fraud. Hindsight I should of
took it to trial, if I knew then what I know now, and better representation.
Things like this can make a person disgruntle, I am angry actually I am
mad as hell... .

Pet. Answer Brief, at 3-4.

Her arguments are no defense to the exclusion. In exclusion proceedings like this one,
any form of collateral attack on predicate convictions is categorically precluded by
regulation at 42 C.F.R. § 1001.2007(d), and that categorical preclusion has been affirmed
repeatedly by the Departmental Appeals Board (Board). Lyle Kai, R.Ph., DAB No. 1979
(2005); Susan Malady, R.N., DAB No. 1816 (2002); Dr. Frank R. Pennington, M.D.,
DAB No. 1786 (2001); Joann Fletcher Cash, DAB No. 1725 (2000); Paul R. Scollo,
D.P.M., DAB No. 1498 (1994); Chander Kachoria, R.Ph., DAB No. 1380 (1993).
6

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

Resolution of a case by summary disposition is appropriate 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.
Michael J. Rosen, M.D., DAB No. 2096; Thelma Walley, DAB No. 1367. Summary
disposition is authorized by the terms of 42 C.F.R. § 1005.4(b)(12). This forum looks to
FED. R. CIV. P. 56 for guidance in applying that regulation. Robert C. Greenwood, DAB
No. 1423 (1993). The material facts in this case are undisputed, clear, and unambiguous.
They support summary disposition as a matter of law, and this Decision is issued
accordingly.

VI. Conclusion

For the reasons set out above, the I.G.’s Motion for Summary Affirmance should be, and
itis, GRANTED. The I.G.’s exclusion of Petitioner Catherine R. Kinnunen from
participation in Medicare, Medicaid, and all other federal health care programs for a
period of five years, pursuant to the terms of section 1128(a)(1) of the Act, 42 U.S.C.

§ 1320a-7(a)(1), is thereby affirmed.

/s/
Richard J. Smith
Administrative Law Judge

"Tam aware that Petitioner’s November 17, 2008 letter — received as her Answer
Brief by the terms of my Order of December 11, 2008 — makes an unspecific and
unsupported assertion that “I had sent evidence regarding my appeals, however it went to
the wrong department, and asked if it could please be forwarded to the appropriate
department.” Having learned in Mark K. Mileski, DAB No. 1945 (2004), that a certain
quantum of mischief can attend such assertions, I here note that I give absolutely no
credence to Petitioner’s assertions concerning mis-sent evidence, if for no other reason
than her conviction of crimena falsi. See, e.g., FED. R. EVID. 404(b). But on the
assumption arguendo that some documents may have been mis-sent, there is still no
reasonable likelihood that any such documents might negate the proof of the two essential
elements.


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
)
Barbara Jean Emerson, ) Date: January 14, 2009

)
Petitioner, )
)

-Vv.- ) Docket No. C-08-632

) Decision No. CR1888
The Inspector General. )
)

DECISION

This matter is before me on the Inspector General’s (1.G.’s) Motion for Summary
Affirmance of the I.G.’s determination to exclude Petitioner pro se, Barbara Jean
Emerson, from participation in Medicare, Medicaid, and all other federal health care
programs for a period of five years. The I.G. relies on the terms of section 1128(a)(1) of
the Social Security Act (Act), 42 U.S.C. § 1320a-7(a)(1). I grant the I.G.’s Motion for
Summary A ffirmance.

I. Procedural Background

Petitioner pro se, Barbara Jean Emerson, was a Licensed Practical Nurse in the State of
Wyoming in 2007, when she became the subject of an investigation into the theft of
certain prescription drugs from residents of a nursing home. On August 23, 2007,
Petitioner was charged by criminal information filed in the Circuit Court for the Fifth
Judicial District, State of Wyoming, with one count of Larceny by a Bailee, in violation of
WYO. STAT. ANN. § 6-3-402(b), a misdemeanor.

Petitioner appeared with counsel in the Circuit Court on January 9, 2008, and pleaded
guilty to the charge. She was sentenced on the same day to payment of a partially-
suspended fine and certain costs, to payment of restitution to the Wyoming Medicaid
program in the sum of $84.35, and to a six-month period of supervised probation.
2

On May 30, 2008, the LG. notified Petitioner that she was to be excluded pursuant to the
terms of section 1128(a)(1) of the Act for the mandatory minimum period of five years.
Acting pro se, Petitioner timely sought review of the I.G.’s action by letter dated July 11,
2008.

I convened a telephonic prehearing conference on August 21, 2008, pursuant to 42 C.F.R.
§ 1005.6, in order to discuss the issues presented by the case and procedures for
addressing them, and, by Order of August 21, 2008, I established a schedule for the
submission of documents and briefs. Pursuant to the terms of paragraph 8 of that Order,
the record in this case closed December 3, 2008. Petitioner has continued to act pro se
throughout these proceedings.

The evidentiary record in this case is made up of the nine exhibits proffered by the LG.,
LG. Exhibits 1-9 (1.G. Exs. 1-9). Petitioner has not objected to these exhibits, nor has she
proffered any exhibits of her own.

II. Issues

The legal issues before me are set out at 42 C.F.R. § 1001.2007(a)(1). They are:

. Whether the I.G. has a basis for excluding Petitioner from participating in
Medicare, Medicaid, and all other federal health care programs pursuant to section
28(a)(1) of the Act; and

N

. Whether the proposed five-year period of exclusion is unreasonable.
As I shall explain below, both issues must be resolved in favor of the I.G.’s position.

Ill. Controlling Statutes and Regulations

Section 1128(a)(1) of the Act, 42 U.S.C. § 1320a-7(a)(1), requires the exclusion from
participation in Medicare, Medicaid, and all other federal health care programs of any
“individual or entity that has been convicted of a criminal offense related to the delivery
of an item or service under Title XVIII or under any State health care program.” The
terms of section 1128(a)(1) are restated in regulatory language at 42 C.F.R.

§ 1001.101(a). This statutory provision makes no distinction between felony convictions
and misdemeanor convictions as predicates for mandatory exclusion.
WYO. STAT. ANN. § 6-3-402(b) provides:

(b) A bailee, a public servant as defined by W.S. 6-5-101(a)(vi) or any
person entrusted with the control, care or custody of any money or other
property who, with intent to steal or to deprive the owner of the property,
converts the property to his own or another’s use is guilty of larceny.

The Act defines “conviction” as including those circumstances “when a judgment of
conviction has been entered against the individual... bya... State... court, regardless
of... whether the judgment of conviction or other record relating to criminal conduct has
been expunged,” section 1128(i)(1) of the Act; “when there has been a finding of guilt
against the individual... bya... State... court,” section 1128(i)(2) of the Act; or
“when a plea of guilty or nolo contendere by the individual ... has been accepted bya...
State ... court,” section 1128(i)(3) of the Act. These definitions are repeated at 42 C.F.R.
§ 1001.2.

An exclusion based in section 1128(a)(1) is mandatory and the I.G. must impose it for a
minimum period of five years. Section 1128(c)(3)(B) of the Act; 42 U.S.C. § 1320a-
7(c)(3)(B). The regulatory language of 42 C.F.R. § 1001.102(a) affirms the statutory
provision.

IV. Findings and Conclusions
I find and conclude as follows:

1. On her accepted plea of guilty on January 9, 2008, in the Circuit Court for the Fifth
Judicial District, State of Wyoming, Petitioner Barbara Jean Emerson was found guilty of
the criminal offense of Larceny by a Bailee, in violation of WYO. STAT. ANN. § 6-3-
402(b). I.G. Ex. 9.

2. The accepted guilty plea, finding of guilt, and judgment of conviction described above
constitute a “conviction” within the meaning of sections 1128(i)(1), 1128(i)(2), and
1128(i)(3) of the Act, and 42 C.F.R. § 1001.2.

3. A nexus and a common-sense connection exist between the criminal offense to which
Petitioner pleaded guilty and of which she was found guilty, as noted above in Finding 1,
and the delivery of an item or service under a State health care program. I.G. Exs. 8, 9.
Berton Siegel, D.O., DAB No. 1467 (1994).
4

4. By reason of Petitioner’s conviction, a basis exists for the I.G.’s exercise of authority,
pursuant to section 1128(a)(1) of the Act, to exclude Petitioner from participation in
Medicare, Medicaid, and all other federal health care programs.

5. Because the five-year period of Petitioner’s exclusion is the mandatory minimum
period provided by law, it is not unreasonable. Section 1128(c)(3)(B) of the Act; 42
C.F.R. §§ 1001.102(a) and 1001.2007(a)(2).

6. There are no disputed issues of material fact and summary disposition is warranted in
this matter. Michael J. Rosen, M.D., DAB No. 2096 (2007); Thelma Walley, DAB No.
1367 (1992); 42 C.F.R. § 1005.4(b)(12).

V. Discussion

The essential elements necessary to support an exclusion based on section 1128(a)(1) of
the Act are: (1) the individual to be excluded must have been convicted of a criminal
offense; and (2) the criminal offense must have been related to the delivery of an item or
service under Title XVIII of the Act (Medicare) or any state health care program. Tamara
Brown, DAB No. 2195 (2008); Thelma Walley, DAB No. 1367; Boris Lipovsky, M.D.,
DAB No. 1363 (1992). Those two essential elements are proven in the record before me.

Petitioner admits that she has been convicted, and the fact of her conviction is clear: I.G.
Ex. 9 shows that on January 9, 2008, Petitioner appeared with counsel in the Court of
Common Pleas and pleaded guilty to the misdemeanor crime of Larceny by a Bailee. The
trial court’s acceptance of that guilty plea and its finding of Petitioner’s guilt appear in the
Arraignment and Sentencing Order reflecting the proceedings, and are underscored by the
fact that the trial court proceeded immediately to the imposition of sentence. I.G. Ex. 9.
Those procedural steps satisfy the definitions of “conviction” set out at sections
1128(i)(1), 1128(4)(2), and 1128(i)(3) of the Act. The LG. has proven the first essential
element.

It is true that the statute that Petitioner pleaded guilty to violating is not on its face
specific to the Wyoming Medicaid program, and it is also true that the court records of
Petitioner’s conviction do not explicitly charge that the drugs she converted to her own
use were intended for Medicaid beneficiaries. But the record in this case does include a
report of the investigation that led to Petitioner’s conviction. I.G. Ex. 8. I may properly
consider this report — even though it is not part of the official court records — for I find
that it is reliable and credible to show the underlying context of Petitioner's conviction:
the contents and source of the report correspond in all particulars to the actual court
records. Narendra M. Patel, M.D., DAB No. 1736 (2000); Tanya A. Chuoke, R.N., DAB
5

No. 1721 (2000); Salmon Daniels, DAB CR1380 (2005); Neitra Maddox, DAB CR1218
(2004). That report reflects the participation of the Wyoming Medicaid Fraud Control
Unit in the investigation, and supplies the names and Medicaid numbers of the nursing
home residents whose medications Petitioner converted to her own use. I.G. Ex. 8, at 1. I
find that the report and the court records demonstrate the requisite nexus and common-
sense connection between the criminal act and the program. Berton Siegel, D.O., DAB
No. 1467.

Moreover, the court records show that Petitioner was ordered to pay restitution in the
amount of $84.35 to “Wyoming Medicaid.” I.G. Ex. 9, at 1. As I have written elsewhere,
if an individual has been convicted of a criminal offense, then proof that any sentence
based on that conviction included the payment of restitution to a protected program
creates a rebuttable presumption of a nexus or common-sense connection between the
conviction and the delivery of an item or service under the program. Alexander
Nepomuceno Jamias, DAB CR1480 (2006). Thus, conclusive proof of the second
essential element is found in I.G. Exs. 8 and 9.

Petitioner asks that I reduce the proposed period of exclusion, or modify it in some way as
to make allowances for her successful completion of probation, and for her determined
efforts to overcome a number of very difficult personal circumstances. I have no reason
at all to doubt Petitioner’s assertions, and parts of the evidentiary record before me
certainly suggest that for nearly a decade prior to the events in this case, Petitioner had
gained control of her self-damaging criminal behavior. I.G. Ex. 8, at 2-4. But what
Petitioner asks is beyond my power to grant. The five-year period of exclusion proposed
in this case is the statutory minimum required by section 1128(c)(3)(B) of the Act. Asa
matter of law, it is not unreasonable. 42 C.F.R. § 1001.2007(a)(2); Mark K. Mileski,
DAB No. 1945 (2004); Salvacion Lee, M.D., DAB No. 1850 (2002); Krishnaswami
Sriram, M.D., DAB CR1463 (2006), aff'd, DAB No. 2038 (2006).

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

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

§ 1005.4(b)(12). This forum looks to FED. R. CIV. P. 56 for guidance in applying that
6

regulation. Robert C. Greenwood, DAB No. 1423 (1993). The material facts in this case
are undisputed and unambiguous. They support summary disposition as a matter of
settled law. This Decision issues accordingly.

VI. Conclusion

For the reasons set out above, the I.G.’s Motion for Summary Affirmance should be, and
is, GRANTED. The I.G.’s exclusion of Petitioner, Barbara Jean Emerson, from
participation in Medicare, Medicaid, and all other federal health care programs for a
period of five years, pursuant to the terms of section 1128(a)(1) of the Act, 42 U.S.C.

§ 1320a-7(a)(1), is thereby affirmed.

/s/
Richard J. Smith
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
)
Techota, LLC, d/b/a CV Home Health ) Date: January 12, 2009

Services, )
)
Petitioner, )
)

-Vv.- ) Docket No. C-08-445

) Decision No. CR1886
Centers for Medicare & Medicaid )
Services. )
)

DECISION

For the reasons stated below, I conclude that Techota, LLC, d/b/a CV Home Health
Services (Petitioner or Techota), was not eligible to participate in the Medicare program
because it did not meet the Medicare conditions of participation governing home health
agencies. Accordingly, I find that the determination of Centers for Medicare & Medicaid
Services (CMS) that Petitioner did not qualify as a home health agency was correct.’

I. Background

Petitioner operated a home health agency (HHA) in Vance, Alabama that applied to
participate in the Medicare program. CMS Posthearing Brief (CMS Br.) at 2. The
Alabama Department of Public Health (the survey agency) performed an initial Medicare
certification survey of Petitioner on October 9-10, 2007. CMS Ex. 1. The survey agency

' At all times relevant during this appeal, Petitioner could have reapplied for
participation in Medicare. In fact, it could have proceeded on this course simultaneously
with this appeal. Petitioner, however, elected to pursue only this appeal of CMS’s
decision that it was not eligible to participate. CMS Exhibits (Exs.) 10, 11; Transcript
(Tr.) 206-211; and CMS Br. at 3.
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determined that Petitioner failed to meet at least two of the conditions of participation
necessary for certification for participation in the Medicare program, namely 42 C.F.R. §
484.18 (Condition of participation: acceptance of patients, plan of care, and medical
supervision) with respect to the administration of the HHA and 42 C.F.R.

§ 484.30 (Condition of participation: skilled nursing services) with respect to the HHA’s
furnishing of services to patients. On November 7, 2007, CMS notified Petitioner of its
determination that Petitioner was not eligible to participate as an HHA in the Medicare
program. CMS Ex. 10. It further informed Petitioner that it could take steps to correct
the deficiencies found and to reapply to establish eligibility. CMS also informed
Petitioner that it could request that CMS reconsider its determination. Petitioner sought
reconsideration from CMS of its determination. By letter dated March 10, 2008, CMS
notified Petitioner of its reconsideration decision. CMS Ex. 11. It determined that the
deficiencies cited under the two conditions of participation were correct and that CMS’s
decision to deny participation was correct. CMS indicated that if Petitioner believed this
decision was incorrect it could request a hearing.

By letter dated May 8, 2008, Petitioner appealed the denial of participation, and the
matter was assigned to me for hearing and decision. I convened a hearing in Atlanta,
Georgia on September 3, 2008. CMS offered offered 11 exhibits, CMS Exs. 1-11 were
admitted. Petitioner offered 21 exhibits, Petitioner Exhibits (P. Exs.) 1-21 were admitted.
The parties submitted posthearing briefs (CMS Br. and P. Br.) and posthearing reply
briefs (CMS Reply and P. Reply).’

If. Analysis
A. Issue presented
This case presents the following issue for my determination-

. The sole issue before me is whether CMS properly determined that Petitioner was
not qualified to participate as an HHA in the Medicare program.

> Petitioner titled its posthearing brief as its posthearing reply brief. I refer to it,
however, as its posthearing brief ( P. BR.) because Petitioner later sought leave to file a
sur reply to CMS’s posthearing reply brief, which I granted. That is referred to as P.
Reply.
B. Applicable law

The Social Security Act (Act) sets forth requirements that a prospective provider of HHA
services must meet in order to participate in the Medicare program, and authorizes the
Secretary of Health and Human Services to promulgate regulations implementing the
statutory provisions. Act, sections 1861(0) and 1891 (42 U.S.C. §§ 1395x(o); 1395bbb).
The Secretary's regulations governing HHA participation in the Medicare program are
found at 42 C.F.R. Part 484.

In order to be eligible to participate in the Medicare program and obtain reimbursement,
42 C.F.R. § 488.3(a)(2) requires that an HHA must be in compliance with all applicable
“conditions” as specified in 42 C.F.R. Part 484. An initial review of compliance with the
conditions of participation is required and such reviews or surveys are conducted by the
state survey agency. Based upon its survey, the state survey agency either certifies
compliance or noncompliance of the surveyed provider. 42 C.F.R. § 488.20.

The state survey agency certifies that an HHA is not in compliance with the conditions for
participation when “the deficiencies are of such character as to substantially limit the
provider’s . . . capacity to furnish adequate care or which adversely affect the health and
safety of patients.” 42 C.F.R. § 488.24(b). Whether or not there is compliance with a
condition of participation depends upon the “manner and degree to which the provider...
satisfies the various standards within each condition.” 42 C.F.R. § 488.26(b); CSM Home
Health Services, DAB No. 1622, at 6-7 (1997). The state survey agency is to assess the
provider’s performance against the appropriate standards to determine and document the
nature and extent of any deficiency and to assess the need for correction or improvement.
Surveyors are required to “directly observe the actual provision of care and services to
residents, and the effects of that care, to assess whether the care provided meets the needs
of individual residents. ...” 42 C.F.R. § 488.26(c). Furthermore, deficiencies, which
considered individually might not constitute violation of a condition of participation,
should also be considered collectively with all other deficiencies to determine whether a
condition of participation has been violated. CSM Home Health Services, DAB No.
1622, at 7.

A prospective provider that is determined not to qualify as a provider by CMS, has a right
to have the determination reviewed in accordance with the procedures of 42 C.F.R. Part
498.

CMS bears the burden of producing evidence sufficient to establish a prima facie case.
CMS must set forth the basis for its determination with sufficient specificity for a
petitioner to respond and come forward with evidence related to the disputed findings.
The evidence set forth by CMS must be sufficient to establish a prima facie case that
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CMS had a legally sufficient basis to determine that a prospective provider did not meet
the participation requirements. In order for a petitioner to prevail, the petitioner must
then prove by a preponderance of the evidence on the record as a whole that it was in
substantial compliance with the relevant statutory and regulatory provisions. Hillman
Rehabilitation Center, DAB No. 1611, aff'd, Hillman Rehabilitation Center v. U.S. Dept.
of Health and Human Services, No. 98-3789 (D.N.J. May 13, 1999).

C. Discussion

The regulations in 42 C.F.R. Part 484 establish the conditions and standards by which
HHA compliance with the Medicare program participation requirements is determined.
The standards set forth in the regulations are essentially the yard sticks by which
surveyors measure the level of compliance of the HHA. If HHA performance does not
measure-up to the regulatory standard, a deficiency exists. If a deficiency is found, the
question is whether that deficiency alone, or considered in combination with another
deficiency, is “of such character as to substantially limit the provider’s . . . capacity to
furnish adequate care or which adversely affect the health and safety of patients. ...” 42
C.F.R. § 488.24(b). Ifthe provider’s capacity to furnish adequate care is substantially
limited, or if the health and safety of patients is adversely affected, then a condition-level
deficiency exists. Consequently, if I determine that Petitioner failed to meet even one
condition of participation, I need go no further and I must affirm CMS’s determination
not to certify the provider for participation in the Medicare program.’

Prospective new providers must be in operation and providing services to patients when
surveyed. This means that, at the time of the survey, the provider must be furnishing all
services necessary to meet the applicable provider definition and demonstrate its
operational capability in all facets of its operations. State Operations Manual (SOM),
section 2008A. A new HHA applicant must be providing skilled home health services to
a minimum of 10 patients before a survey is conducted and, at the time of the survey, the
HHA must be providing care to at least seven of the 10 required patients. SOM, section
2008B. At the time of the certification survey of this HHA, it was treating 10 patients
and the survey found deficiencies with respect to four of the 10 patients.’

* T must point out that at all times relevant to this matter, Petitioner also had the
option of correcting the particular deficiencies and reapplying for certification and
participation in the Medicare program, but it chose not to pursue that course of action.
Tr. 211.

* CMS contends deficiencies with respect to just less than half of the entire patient
sample is indicative of serious systemic problems with the HHA. See also Tr. at 34-35.
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1. Because Techota was not in compliance with one Medicare condition of
participation, CMS appropriately decided not to certify Techota for
participation as an HHA in the Medicare program.

a. Petitioner did not meet the condition of participation at
42 C.F.R. § 484.18 (Tags G 159 (plan of care) and G 165
(conformance with physician orders)).

The regulation on which this participation requirement is based states—

Condition of participation: Acceptance of patients, plan
of care, and medical supervision.

Patients are accepted for treatment on the basis of a
reasonable expectation that the patient’s medical, nursing, and
social needs can be met adequately by the agency in the
patient’s place of residence. Care follows a written plan of
care established and periodically reviewed by a doctor of
medicine, osteopathy or podiatric medicine.

(a) Standard: Plan of care. The plan of care developed in
consultation with the agency staff covers all pertinent
diagnoses, including mental status, types of services and
equipment required, frequency of visits, prognosis,
rehabilitation potential, functional limitations, activities
permitted, nutritional requirements, medications and
treatments, any safety measures to protect against injury,
instructions for timely discharge or referral, and any other
appropriate items. If a physician refers a patient under a plan
of care that cannot be completed until after an evaluation
visit, the physician is consulted to approve additions or
modifications to the original plan. Orders for therapy services
include the specific procedures and modalities to be used and
the amount, frequency, and duration. The therapist and other
agency personnel participate in developing the plan of care.

42 CER. § 484.18(a).
Tag G 159 and Tag G165

The surveyors determined that Techota failed to meet these particular standards under the
condition of participation for two of eight patient records reviewed. The surveyors first
found that Petitioner failed to follow the patients’ plans of care. All home health care
services must be authorized and directed by the patient’s physician. 42 C.F.R.

§ 484.18(a). This authorization and direction is effectuated by written individualized
plans of care for each patient and signed by the physician. Therefore, a skilled nurse can
only provide services as ordered by the physician and cannot operate outside the
boundaries of the plan of care. Techota’s own written policies echo the regulatory
requirements and home health industry standards of care. The policy for patient plans of
care indicate that any patient services by Techota must be under medical supervision
requiring a plan of care, signed by the patient’s physician, which is developed by the
HHA upon admission and which is reviewed and revised as needed but at least every 60
days. The policy further states that all interim verbal orders from a physician must be
confirmed in writing and signed by the physician and that all interventions and treatments
provided by the HHA are to be consistent with the patient’s plan of care. See CMS Ex. 8,
at 6-7.

The surveyors then determined that Petitioner failed to meet another standard, Tag G165,
under the condition of participation, when Petitioner administered an injection of
Lovenox, a blood thinner, to a patient on two occasions without an order by the physician
and without indication in the plan of care that this was an ordered medication, treatment
or intervention. 42 C.F.R. § 484.18(c).

Patient Medical Record (MR) 4

Patient MR4 was a 52-year-old woman whose physician admitted her to Petitioner’s
agency on August 27, 2007. CMS Ex. 3, at 4. The plan of care stated at Section 21 that
Patient MR4 was to receive skilled nursing services twice a week for 21 days and then
once a week for 39 days. She was also to receive the services of a home health aide twice
a week for 60 days. CMS Ex. 3, at 4; P. Ex. 12, at 41; Tr. 36. Also, under the section
titled, Orders for Discipline and Treatments, it indicates on an addendum page “wound”
and “assess wound for healing,” “assess circumference, depth, character and presence or
absence of infection,” “change dressings.” The plan of care also indicates in Section 22,
Goals/Rehabilitation Potential/Discharge Plans, that the primary goal of the HHA services
to be rendered to Patient MR4 is “to promote the healing of skin tears @ sacrum/gluteal
folds.” Id.
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The surveyor found that the HHA did not provide the twice weekly frequency for skilled
nursing care for the first 21 days as ordered by the physician and as set forth in the
patient’s plan of care. The surveyor examined the medical record for this patient and
noted the date of each nurse’s note in the record. The surveyor found that the patient was
provided skilled nursing care twice during the first week but thereafter skilled nursing
services were provided only once a week for week two and week three (up to September
16, the 21“ day).’ CMS Ex. 1, at 3; Tr. 37-38. Petitioner does not dispute that the
requisite skilled nursing visits were not made during week two, but contends that
Petitioner provided skilled nursing visits three times (twice on September 12 and once on
September 14) during week three.° P. Br. at 7. I find no basis for Petitioner’s
contention. I examined the records. The records indicate a nurse’s note for September 12
(P. Ex. 12, at 102-06) and the same RN also filled out a form assessing, in a supervisory
capacity, the care given to the patient by the home health aide (P. Ex. 12, at 102). Thus,
the record does not establish that there were two skilled nursing visits made on the same
day. As for the assertion that a skilled nursing visit was made on September 14, 2007,
there is no nurse’s note for that date in the record. Petitioner contends that its
computerized log indicated an RN routine visit on September 14, 2007. However, upon
closer examination, Petitioner agreed that indeed there was a discrepancy in the
computerized calender-log. While the calendar indicated an RN visit, the same form
indicated below on the billing information that the visit was actually made by the home
health aide. P. Ex. 12, at 2; Tr. 191-92; CMS Reply Br. at 4-5; Petitioner’s Br. at 7.
There is no indication from the patient’s medical record that there was any skilled nursing
care rendered to the patient on September 14.

Petitioner nevertheless would have me believe that this is a minor issue; it contends that
while skilled nursing services may not have been rendered as scheduled, a home health
aide still provided services to the patient twice a week during this time so that someone
was in the patient’s home “checking on her.” P. Br. at 7. This does not lessen the
deficiency or lead me to find that Petitioner still met the relevant condition of
participation. Here, Petitioner’s RN made a complete assessment of the patient and
determined that based on the patient’s condition, the patient needed skilled nursing

* CMS determined that Petitioner provided skilled nursing services on the
following dates only during the first 21 days: August 27, August 31, September 4, and
September 12, 2007. CMS Br. at 7-8; CMS Ex. 3, at 33, 40, 42, 44; Tr. 38.

® Petitioner also argued that an additional skilled nursing visit was made during
week one on August 28. P. Br. at 7. However, the medical records reveal that no such
skilled nursing visit was made to the patient on that date; rather, the RN called the
patient’s physician. P. Ex. 12, at 81, 84. This is not considered a skilled nursing visit
under the plan of care.
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services at least twice a week for 21 days in addition to twice weekly home health aide
services. If the RN believed the patient needed skilled care for less than that, the plan of
care would have so stated. Also, the patient’s physician signed the plan of care. In doing
so, the physician is ordering that skilled nursing services be rendered to the patient twice
a week. Failure to provide those services amounts to a failure to follow the physician’s
specified order. But, more importantly, failure to follow the plan of care is breach of the
regulatory requirement. 42 C.F.R. § 484.18(a). The condition of participation here has as
one of its primary standards that each patient must have a plan of care that covers, among
other things, all pertinent diagnoses, types of services and equipment required, frequency
of visits, and medication and treatment appropriate for the specific patient. Failure to
provide the frequency of the visits prescribed for rendering skilled nursing care is indeed
a significant deficiency and a failure to meet the required standard. Also, as CMS pointed
out, failure to provide this patient with the required twice weekly skilled nursing services
was significant because she had a “wound” that needed to be assessed, cleansed, and
dressed, and there is no indication from the plan of care that there was anyone in the
household who was capable of providing, or was taught by the RN to provide, the
necessary wound care. Tr. 39.

Petitioner also failed to properly develop the plan of care for Patient MR4. An HHA
provides services and treatments to a patient in their home and the same nurse may not be
providing the services each time. Therefore, the plan of care must be complete and
comprehensible. It must indicate all the diagnoses and specify the treatments in such a
way that the provider of the services knows what treatment to provide. The plan of care
also should specify what supplies will be needed to provide the services in the plan of
care, so that when the RN provides the requisite services she brings with her the supplies
necessary to perform those services.’ Tr. 43-44. Here, although this patient’s “wound”
was of primary concern to her physician, and treatment of the wound is listed as a
treatment order, there is no diagnosis listed regarding the wound nor are there any
supplies listed for cleansing and dressing the wound. See P. Ex. 12, at 82-83; Tr. 41-42.
As the surveyor pointed out in her testimony, the plan of care lacks the necessary
specificity. The only mention of the location on the wound is in Section 22, Goals. The
plan of care, at the very least, should have indicated where the wound was, and described
the condition of the wound, its dimensions and depth, and any other pertinent information
which would be useful in assessing and staging the wound. There is no specificity in the
plan of care as to how this wound should be treated; should it be cleansed with soap and

7 Under section 14 of the plan of care form, all medical supplies and equipment
necessary for the patient are supposed to be listed.
9

water or is saline necessary, should a transparent dressing be used or another kind of
dressing be used? The orders for wound care should have specified these matters, and if
the patient’s physician did not so specify, the nurse should have contacted the physician
for specific orders.*

As the surveyor pointed out, however, the RN did perform a comprehensive start of care
assessment and the form filled out during that assessment has certain information that
then was expected to be placed in the plan of care.? See CMS Ex. 3, at 6-32. For
example, any question in the assessment that is noted by several stars also states the
specific section in the HCFA Form 485, the plan of care, where this information should
be input. Here the assessment form indicated that in Section 13, under medical supplies,
the plan of care should have included the following: 4x4 gauze, alcohol prep, gloves,
saline, Tegaderm, and wound cleanser. CMS Ex. 3, at 30. Yet none of these supplies
were included on the plan of care (HCFA Form 485); in fact, no supplies for any kind of
wound or pressure sore care was included.'” P. Ex. 12, at 82; Tr. 45-46. Clearly, this too
demonstrates the lack of necessary specificity in the plan of care. As CMS pointed out,
this lack of required specificity in the plan of care means that Petitioner never had a
complete written order for treatment of the patient’s wound which was signed by her
physician. CMS Br. at 8-9 and Reply at 5.

Therefore, I find significant failures with respect to the plan of care for Patient MR4 and
that these failures clearly impacted the treatment provided to Patient MR4. Indeed, the
failures with respect to this patient’s wound care had the potential for causing harm to this
patient, including the possibility of infection or sepsis. I also find it significant that

since this was an initial certification survey to determine if Petitioner met the conditions

* Apparently, the RN contacted the doctor for clarification, but the plan of care
does not include any supplemental treatment order nor does the medical record contain
any signed physician order as required by the HHA’s own policy. CMS Ex. 8, at 1; Tr.
54-55.

° Petitioner’s RN also filled out a Wound Assessment form at the time that the
Start of Care Assessment was performed. However, this information included in this
form was not inputted into the Plan of Care. See CMS Ex. 3, at 33-38; Tr. at 48.

'° | find this puzzling considering that the Wound Assessment Form indicates
“current treatments” for the patient’s wound care, including that the wound had been
cleansed with soap and tap water with “Duoderm” dressing, yet nothing of this specificity
is included in the plan of care, and the start of care assessment form suggested very
different cleaning methods and dressing type. P. Ex. 12, at 77, compared with 67; Tr.
48-50.
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of participation, these kinds of failures, for even one patient, when Petitioner is only
treating 10 patients, demonstrated that Petitioner was not qualified to participate in
Medicare at the time of the survey.

Patient MR5

Patient MR5 was a 79-year-old man admitted to Petitioner’s agency on August 8, 2007.
CMS Ex. 5, at 4. The statement of deficiency indicated that Petitioner’s Nurses Notes for
visits to this patient on August 16, 2007, documented that the RN administered Lovenox
by injection to Patient MRS on two visits. CMS Ex. 5, at 4-5, 15. There were no notes as
to the amount of the drug administered. The plan of care for Patient MRS did not list this
drug as one of the medications for this patient nor did it indicate that the RN should
administer or “teach” the patient’s spouse caregiver how to administer the injection.

CMS Ex. 5, at 4-5. Lovenox is a blood thinner. Petitioner’s administration of this
medication was cited as a deficiency under both the Tag F159 - Plan of Care, and Tag
F165 - Conformance with Physician Orders.

Petitioner does not dispute that this medication is not listed on the patient’s plan of care.
Petitioner contends that it was not on the plan dated August 8 for two reasons: one,
because the patient received the medications in pre-filled syringes from Critical Care
Systems ,who referred Patient MRS to Petitioner; and, two, because the medication was
not ordered by the physician until August 15. P. Br. at 10-11. Petitioner also contends
that the RN only administered the injections on two occasions in order to provide a
reminder demonstration to the patient’s spouse, who had been instructed on how to
administer the medication at the hospital. P. Br. at 11.

Neither reason excuses the error or changes the fact that the medication was administered
without the plan of care indicating that Patient MR5 was prescribed this medication, and
the physician had not ordered the HHA nurse to administer the injection or teach the
patient’s spouse how to administer the medication. Petitioner’s own policy manual
specifically provides that orders for medication and its administration by the HHA can
only be taken from the physician and that orders for medications will be given only on
written or phone orders by the physician to a RN or LPN. CMS Ex. 8, at 1. The
medication policy further provides that when a new medication is ordered it is added to
the patient’s medication profile along with any appropriate information. CMS Ex. 8, at 2-
5. For any injection, however, the medication policy specifically provides that for the RN
to administer an injection and to provide teaching to the family to administer the injection
requires specific written and signed orders by the patient’s physician. CMS Ex. 8, at 3.
Finally, Petitioner’s own policies provide that all interventions and treatments provided
by Petitioner’s staff must be consistent with the plan of care and conform to the
physician’s orders and any interim verbal orders from the physician must be promptly
11

confirmed in writing and signed by the physician. CMS Ex. 8, at 6. Contrary to
Petitioner’s contentions, it has wholly failed to rebut CMS’s prima facie case of
Petitioner’s noncompliance with respect to Patient MRS with Tag G159 in providing care
in accordance with the patient’s plan of care, and under Tag G165, that requires that

drugs and treatments are administered by agency staff only as ordered by the physician. If
it had met this standard it would have been easy to prove its compliance by showing the
conforming plan of care and the necessary written signed order by Patient MR5’s
physician. Petitioner did not do so.

Petitioner’s failure to meet two out of the three standards under the condition of
participation is significant. Petitioner’s failures indicate to me a lack of capacity to
furnish adequate care that had the potential to adversely affect the health and safety of
Petitioner’s patients. I find by a preponderance of the evidence that Petitioner failed to
meet the condition of participation at 42 C.F.R. § 484.18.

Ill. Conclusion

Based on the above findings and analysis, I sustain CMS’s determination that Techota, a
prospective provider, was not in substantial compliance with the Medicare conditions of
participation necessary to be certified as an HHA provider. In so finding, I determined
that Petitioner’s deficiencies would substantially limit its capacity to furnish adequate
care or would adversely affect the health and safety of patients.

/s/
Alfonso J. Montano
Administrative Law Judge