Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Golden Living Center — Colonial Manor
(CCN: 52-5309),

Petitioner
v.

Centers for Medicare and Medicaid Services.
Docket No. C-11-398
Decision No. CR2504

Date: February 22, 2012

DECISION

Petitioner, Golden Living Center — Colonial Manor (Petitioner or facility), is a long term
care facility located in Glendale, Wisconsin, that participates in the Medicare program.
Based on a survey completed on January 12, 2011, the Centers for Medicare and
Medicaid Services (CMS) determined that Petitioner was not in substantial compliance
with Medicare participation requirements. CMS imposed against Petitioner a civil money
penalty (CMP) of $700 per day effective January 12 through February 14, 2011, for a
total CMP of $23,800.

Petitioner appealed, and CMS moves for summary judgment.

For the reasons set forth below, I grant summary judgment. The undisputed facts
establish that the facility was not in substantial compliance with 42 C.F.R. §§ 483.25(1)
(Tag F329 unnecessary drugs), 483.60(a), (b) (Tag F425 pharmaceutical services), and
483.75(1)(1) (Tag F514 clinical records). I also find that the $23,800 CMP that CMS
imposed is reasonable.
I. Background

The Social Security Act (Act) sets forth requirements for nursing facilities’ participation
in the Medicare program and authorizes the Secretary of Health and Human Services
(Secretary) to promulgate regulations implementing those statutory provisions. Act

§ 1819. The Secretary’s regulations are found at 42 C.F.R. Part 483. To participate in
the Medicare program, a nursing facility must maintain substantial compliance with
program requirements. To be in substantial compliance, a facility’s deficiencies may
pose no greater risk to resident health and safety than “the potential for causing minimal
harm.” 42 C.F.R. § 488.301.

The Secretary contracts with state agencies to conduct periodic surveys to determine
whether skilled nursing facilities are in substantial compliance. Act § 1864(a); 42 C.F.R.
§ 488.20. The Act and regulations require that each facility be surveyed once every 12
months and more often, if necessary, to ensure that identified deficiencies are corrected.
Act § 1819(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308.

Surveyors from the Wisconsin Department of Health Services conducted a survey of
Petitioner that ended on January 12, 2011. Based on their findings, CMS determined that
the facility was not in substantial compliance with numerous Medicare requirements and
imposed a CMP of $700 per day effective January 12 through February 14, 2011, fora
total CMP of $23,800. After a revisit survey, CMS found that the facility returned to
substantial compliance on February 15, 2011.

On April 15, 2011, Petitioner timely requested a hearing contesting all findings of
noncompliance and related sanctions set forth in the CMS notices issued on February 17
and March 16, 2011. The case was assigned to me for hearing and decision. On

April 20, 2011, I issued an Acknowledgement and Initial Pre-Hearing Order establishing
a briefing schedule. In accordance with the schedule, on July 1, 2011, CMS submitted a
motion for summary judgment and memorandum (CMS Br.), along with 28 exhibits
(CMS Exs. 1-28). On August 2, 2011, Petitioner submitted a response in opposition to
CMS’s motion for summary judgment (P. Br.) and 15 exhibits (P. Exs. 1-15).

IL. Issues
e Whether, from January 12 through February 14, 2011, the undisputed facts

establish that Petitioner was in substantial compliance with 42 C.F.R. §§ 483.25(1),
483.60(a), (b), and 483.75(1)(1); and

e If Petitioner was not in substantial compliance, whether the $700 per day CMP
CMS imposed is reasonable.
II. Discussion

Summary judgment is appropriate when a case presents no issue of material fact, and its
resolution turns on questions of law. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242,
247-48 (1986); Livingston Care Ctr. v. United States Dep’t of Health and Human Servs.,
388 F.3d 168, 173 (6th Cir. 2004). See also Illinois Knights Templar Home, DAB No.
2274, at 3-4 (2009) (citing Kingsville Nursing Ctr., DAB No. 2234, at 3-4 (2009)). The
moving party may show the absence of a genuine factual dispute by presenting evidence
so one-sided that it must prevail as a matter of law, or by showing that the non-moving
party has presented no evidence “sufficient to establish the existence of an element
essential to [that party’s] case, and on which [that party] will bear the burden of proof at
trial.” Livingston Care Ctr., 388 F.3d 168, 173 (quoting Celotex Corp. v. Catrett, 477
US. 317, 323-24 (1986)). To avoid summary judgment, the non-moving party must then
act affirmatively by tendering evidence of specific facts showing that a dispute exists.
See Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586 n.11 (1986);
see also Vandalia Park, DAB No. 1939 (2004); Lebanon Nursing and Rehab. Ctr., DAB
No. 1918 (2004). To defeat an adequately supported summary judgment motion, the
non-moving party may not rely on the denials in its pleadings or briefs, but it must
furnish evidence of a dispute concerning a material fact. [/linois Knights Templar Home,
DAB No. 2274, at 4; Livingston Care Ctr., DAB No. 1871, at 5 (2003).

In examining the evidence for purposes of determining the appropriateness of summary
judgment, I must draw all reasonable inferences in the light most favorable to the non-
moving party. Brightview Care Ctr., DAB No. 2132, at 2, 9 (2007); Livingston Care
Ctr., 388 F.3d at 168, 172; Guardian Health Care Ctr., DAB No. 1943, at 8 (2004); but
see Cedar Lake, DAB No. 2344, at 7; Brightview Care Ctr., DAB No. 2132, at 10
(upholding summary judgment where inferences and views of non-moving party are not
reasonable). However, drawing factual inferences in the light most favorable to the non-
moving party does not require that I accept the non-moving party’s legal conclusions.
Cedar Lake, DAB No. 2344, at 7; Guardian Health Care Ctr., DAB No. 1943, at 11 (“A
dispute over the conclusion to be drawn from applying relevant legal criteria to
undisputed facts does not preclude summary judgment if the record is sufficiently
developed and there is only one reasonable conclusion that can be drawn from those
facts.”).

Petitioner failed to tender sufficient evidence allowing me to draw reasonable inferences
in its favor creating a genuine dispute of material fact regarding the deficiencies at issue
here. Petitioner relies mainly on the declaration of Jameie Williams, R.N., Petitioner’s
Director of Nursing (DON), to challenge the material facts that CMS alleges, which are
that (CMS Br. at 3): 1) the facility continued to administer an antipsychotic to a resident
without adequate indications documented in the resident’s clinical record to justify its
continued administration; 2) the facility did not monitor for the need, reduction, or
discontinuation of the administration of the antipsychotic; 3) the facility did not dispense
and administer medications to three residents in accordance with their medical
professionals’ orders; 4) the facility did not come forward with any proof of an accurate
pharmaceutical reconciliation for these three residents; and 5) the facility did not
maintain clinical records on these three residents that it completely and accurately
documented. Even when I construe DON Williams’ declaration and Petitioner’s other
exhibits in the light most favorable to the Petitioner, Petitioner was not able to come
forward with sufficient evidence to dispute the fact that for 24 days a resident continued
to receive an antipsychotic without proper monitoring, and the facility did not reconcile
records showing that three residents did not receive their medications as their medical
professionals ordered.

My findings and conclusions are set forth in the bold italicized headings and supported by
the discussions in the sections below.

A, CMS is entitled to summary judgment that Petitioner was not in substantial
compliance with 42 C.F.R. § 483.25(l) because the undisputed evidence
establishes that Petitioner did not monitor for the need, reduction, or
discontinuation of the administration of the antipsychotic drug Haldol to
Resident 8.

Under the Act and the “quality of care” regulation, each resident must receive, and the
facility must provide, the necessary care and services to allow a resident to attain or
maintain the highest practicable physical, mental, and psychosocial well-being, in
accordance with the resident’s comprehensive assessment and plan of care. Act

§ 1819(b); 42 C.F.R. § 483.25. Each resident’s drug regime must be free from
unnecessary drugs. Unnecessary drugs include drugs used in excessive doses, drugs used
for an excessive duration, drugs that are not adequately monitored, drugs used without
adequate indications for their use, and drugs whose adverse consequences indicate that
they should be reduced or discontinued. See 42 C.F.R. § 483.25(1)(1).

Additionally, special rules apply to the use of antipsychotic drugs. Based on a resident’s
comprehensive assessment, the facility must ensure that a resident who has not used
antipsychotic drugs is not given them unless necessary “to treat a specific condition as
diagnosed and documented in the clinical record.” Unless contraindicated, the facility
must also ensure that it gradually reduces doses and implements behavioral interventions
to discontinue the antipsychotics.' 42 C.F.R. § 483.25(1)(2).

Responding to comments, the drafters of the regulation explained that an “unnecessary
drug” is “reserved for drug therapy circumstances” that CMS guidelines establish “are a
potential threat to the resident’s health and safety, and for which the facility is unable to

' Petitioner’s own Policy & Procedure Manual regarding Medication Management
mirrors the language set out in subsections | and 2 of this regulation. See CMS Ex. 6.
justify why using a drug under such circumstances is in the best interest of the resident.”
The facility “can certainly rely on physician justification of the risk-benefit of the drug
use,” but it cannot simply claim that “the doctor ordered it.” Requiring only a
physician’s order to justify a questionable drug “would render the regulation, and the
statutory underpinnings for it, meaningless.” 56 Fed. Reg. 48,826, 48,851-52 (Sept. 26,
1991).

CMS cited Petitioner for an unnecessary drug deficiency involving the administration of
the antipsychotic drug Haldol (haloperidol). Haldol is used to treat the symptoms of
delirium and is usually prescribed for a short period of time in order to stabilize a
patient’s cognitive state. CMS Ex. 8, at 6. In all patients, response to antipsychotics
should be monitored at least every 24 hours. Jd. Once a patient’s cognitive state
stabilizes, Haldol should be administered over the next few days, then tapered, and then
discontinued. Jd. For over three weeks the facility administered the antipsychotic to one
resident, identified as Resident 8 (R8).

R8, a 70-year-old female, was admitted to the facility on November 2, 2010, suffering
from a number of conditions, including congestive heart failure, chronic obstructive
pulmonary disease, hypertension, diabetes, obesity, sleep apnea, and osteoarthritis. CMS
Ex. 7, at 33. R8’s treatment regimen included several medications but did not include
Haldol. Id. On December 6, 2010, R8 experienced respiratory distress and was admitted
to a hospital with sepsis and hypoxia. CMS Ex. 7, at 8, 12-13, 42. R8 began exhibiting
confusion and agitated behaviors, such as repeated attempts to get out of bed. CMS Ex.
7, at 8; P. Br. at 11. A hospital psychiatrist evaluated R8 and diagnosed her with
“{dJelirium secondary to sepsis and hypoxia.”” CMS Ex. 7, at 9. The psychiatrist
recommended a range of Haldol as needed for agitation “‘so as to allow diminishing doses
as she medically clears.” CMS Ex. 7, at 9.

After more than a week in the hospital, R8 was prepared for discharge. Her final hospital
evaluation noted that her delirium had “improved today” and ordered the continuation of
0.5 milligrams (mg.) of Haldol each day at bedtime. CMS Ex. 7, at 10. The hospital
discharge summary indicated that R8 “did experience prolonged episodes of delirium and
agitation throughout her stay” and required Haldol, as needed, for her agitation. CMS
Ex. 7, at 13. The discharge summary included a list of R8’s medications at discharge that
included a notation of 0.5 mg. of Haldol as a handwritten addition to the otherwise typed
list. CMS Ex. 7, at 11, 14.

On December 13, 2010, the hospital discharged R8, and the facility readmitted her. The
facility’s orders beginning on that date included 0.5 mg. Haldol at bedtime every day.
CMS Ex. 7, at 15. The facility completed an “Immediate Plan of Care” for alteration of
skin integrity, the use of oral anticoagulants, and the following risks: pain; skin

? Delirium is a temporary condition resulting from a co-existing condition such as an
infection. CMS Ex. 10. Haldol is a drug approved to treat delirium. CMS Ex. 5, at 41.
breakdown; respiratory problems; cardiovascular problems; and falls. CMS Ex. 7, at 21-
27. There was no Immediate Plan of Care for R8’s use of antipsychotics. See CMS Ex.
7. A “Behavior Monthly Flow Sheet,” dated December 2010, was present in R8’s file.
CMS Ex. 7, at 28. The form is a pre-printed checklist that states it should be used when a
resident is administered certain classes of medication, including antipsychotics, such as
Haldol. The form lists possible behaviors to monitor, possible staff interventions, and
provides space to document resident responses to those interventions. However, other
than R8’s name, physician’s name, and date, the form is completely blank. CMS Ex. 7,
at 28.

Petitioner’s staff began administering 0.5 mg. of Haldol to R8 after readmission.
Petitioner claims it continued administering Haldol until a psychologist, Dr. Heimler,
evaluated R8 24 days later on January 6, 2011. P. Ex. 3; P. Br. at 13. On that date, Dr.
Heimler discussed the antipsychotic with Nurse Practitioner (NP) Lisa Lockwood. NP
Lockwood discontinued the medication on that same date. CMS Ex. 7, at 30. This was
also the same day that the surveyor inquired about the status of R8’s treatment with
Haldol. CMS Ex. 1, at 65.

To defeat CMS's motion for summary judgment, Petitioner must do more than deny the
allegations. It must furnish evidence of specific facts showing that a dispute exists.
Petitioner claims that—consistent with the regulatory requirements and its own policy—(1)
a nurse practitioner appropriately assessed, evaluated, and monitored R8 upon
readmission; and (2) Haldol was medically necessary—for 24 days-to treat R8’s delirium,
and the administration of Haldol was appropriately discontinued in a timely manner.
Petitioner, however, has not come forward with clinical records supporting its assertions.
Further, Petitioner has not provided an affidavit from NP Lockwood disputing that R8
failed to receive a proper assessment for the administration of the antipsychotic drug.
Based on the evidence presented, the only reasonable inference that can be drawn from
the undisputed facts is that, prior to the survey, the facility did not properly assess R8 for
unnecessary drugs or implement interventions to assure that R8 was not unnecessarily
medicated or experiencing adverse reactions to administered antipsychotic medication.

Petitioner argues that, the same day that R8 was readmitted, NP Lockwood evaluated R8,
“noted the Haldol order, determined that she did not want to change it until she could be
sure that the delirium did not recur at the nursing facility and a mental health professional
conducted a more thorough evaluation, and so she ordered the medication continued, and
a mental health evaluation as soon as possible.” P. Br. at 13; see P. Ex. 1, at 6. To
support its position, Petitioner cites only a computer printout progress note authored by
NP Lockwood. P. Ex. 2. This progress note, dated January 6, 2011, 24 days after R8’s
readmission, simply states:
Resident seen by [behavioral health consultant psychologist] today.
Resident has been on scheduled Haldol at bedtime since readmission
secondary to delirium. Delirium issues are resolved at this time.

P. Ex. 2. NP Lockwood does not reference a previous evaluation, assessment, order, or
referral—all of which Petitioner alleges were performed. P. Br. at 13. Before the date of
discontinuation, nowhere in the record did Petitioner provide any clinical records
reflecting NP Lockwood’s assessment upon readmission, let alone one that contains a
review of R8’s signs or symptoms of delirium and whether they indicated the continued
need for the antipsychotic.

Again, Petitioner has not come forward with any clinical records showing NP Lockwood
ordered the continued administration of Haldol. There are no clinical records that NP
Lockwood ordered Petitioner’s staff to monitor R8 to assure the medication was effective
in treating signs and symptoms of delirium or to monitor R8 for possible side effects.
The only proffered evidence of a clinical record in defense of this cited deficiency is the
progress note, written more than three weeks after the purported readmission evaluation,
which does not support Petitioner’s position that it was necessary to continue to
administer Haldol to R8 after her readmission.

The only support Petitioner offers for NP Lockwood’s purported readmission evaluation
is DON Williams’ declaration. P. Br. at 13; P. Ex. 1. She asserts that:

The same day the Resident returned [December 13, 2010], a Nurse
Practitioner named Lisa Lockwood evaluated her, noted the Haldol order,
determined that she did not want to change it until she could be sure that
the delirium did not recur at the nursing facility, and a mental health
professional conducted a more thorough evaluation, and so she ordered the
medication continued, and a mental health evaluation as soon as possible.
That evaluation took place on January 6, 2011, which is as soon as it was
possible to arrange the consultation during the holiday season.

P. Ex. 1, at 6. For the purposes of summary judgment, I am not required to accept as true
inferences that are unreasonable. And considering there is no clinical documentation of
NP Lockwood’s purported December 13, 2010 assessment, or an affidavit from NP
Lockwood, I will not infer that this assessment took place. Nevertheless, even if I were
to accept as true that NP Lockwood did assess R8’s need for continued Haldol upon
readmission, nowhere in Petitioner’s clinical records is there evidence to show the facility
properly monitored R8 for potential side effects or signs or symptoms of delirium to
justify the drug’s use for 24 days after the facility readmitted R8.

Interestingly, although Petitioner argues that Haldol was medically necessary to treat
R8’s delirium and, as such, the facility administered the drug upon R8’s December 13,
2010 readmission and continued it until January 6, 2011, the Medication Administration
Record (MAR)? inexplicably reflects that the facility did not administer Haldol to R8 on
December 13, December 29, or at any time in January 2011. See CMS Ex. 7.

Considering Petitioner has not come forward with evidence establishing a factual dispute
as to whether the facility kept R8 free from unnecessary drugs, whether it be by not
showing adequate continued indications for administration of Haldol nor adequate
monitoring of the Haldol under the terms of 42 C.F.R. § 483.25(1), I find the facility is
not in substantial compliance with this deficiency, and CMS is entitled to summary
judgment.

As I discuss later, I find the seriousness of this violation alone substantiates the $700 per
day CMP that CMS imposed upon the facility. Nonetheless, I also consider the other
violations CMS alleges in its motion for summary judgment.

B. CMS is entitled to summary judgment that Petitioner was not in substantial
compliance with 42 C.F.R. § 483.60(a) and (b) because the undisputed evidence
establishes Petitioner did not accurately dispense and administer drugs to meet
the needs of Resident 10 and Resident 32 nor did Petitioner come forward with
an accurate reconciliation for these residents’ drug records.

42 C.F.R. § 483.60(a) and (b) require the following:

(a) Procedures. A facility must provide pharmaceutical services
(including procedures that assure the accurate acquiring, receiving,
dispensing, and administering of all drugs and biologicals) to meet
the needs of each resident.

(b) Service consultation. The facility must employ or obtain the
services of a licensed pharmacist who--
(1) Provides consultation on all aspects of the provision of
pharmacy services in the facility;
(2) Establishes a system of records of receipt and
disposition of all controlled drugs in sufficient detail to
enable an accurate reconciliation; and

* A MAR is the facility document that specifies how each mediation is administered to a
resident.
(3) Determines that drug records are in order and that an
account of all controlled drugs is maintained and
periodically reconciled.

42 C.F.R. § 483.60(a) , (b) (Emphasis added).
Resident 10

R10 was a 70-year old male whose diagnoses included fungal lumbar spinal discitis,
chronic kidney disease, bilateral knee replacement, chronic obstructive pulmonary
disease, chronic ischemic heart disease, osteoarthritis, a left heel ulcer, and mild cognitive
impairment. CMS Ex. 13, at 1,7. He needed pain management and monitoring related
to his left foot/heel wound, fungal lumbar spinal discitis, and peripheral vascular disease.
CMS Ex. 13, at 15.

R10 was admitted to Petitioner’s facility on October 14, 2010. See CMS Ex. 1, at 94; P.
Ex. 5, at 3. The record shows that on October 18, 2010, R10 had a nurse practitioner’s
order for Oxycontin, 10 mg. by mouth every eight hours, and oxycodone, 10 mg. by
mouth every four hours, as needed. P. Ex. 5, at 1. Oxycontin is a trade name for a long-
acting, extended release narcotic pain medication containing oxycodone. Oxycodone is a
short-acting narcotic pain medication. On October 27, 2010, the nurse practitioner
changed R10’s Oxycontin order, increasing the dosage to 20 mg. by mouth every eight
hours. P. Ex. 5, at 2. Following a hospital stay for exacerbation of his cardiac and
respiratory ailments, R10 was readmitted to Petitioner’s facility on December 1, 2010.
On that date, the nurse practitioner gave a new order for Oxycontin, 20 mg. by mouth
every 12 hours, and continued the previous order for oxycodone, 10 mg. by mouth every
four hours, as needed for pain. See CMS Ex. 1, at 94; CMS Ex. 13, at 17.

The record shows that the nurse practitioner’s new order for Oxycontin every 12 hours
was not entered into R10’s December 2010 MAR, and instead, the old order for
Oxycontin every eight hours was incorrectly entered. CMS Ex. 13, at 18-19.

As alleged in the SOD, on the following dates, R10’s Individual Narcotic Record (INR),
a log on which nursing staff signed-out the narcotics, shows that nursing staff gave R10
Oxycontin three times a day, instead of every 12 hours as ordered:

December 16, 2010 - Petitioner administered 20 mg. of Oxycontin to
R10 at 6a.m., 12 p.m., and 8 p.m. See CMS Ex. 1, at 95; CMS Ex.
13, at 18, 22.

December 28, 2010 - Petitioner administered 20 mg. of Oxycontin to
R10 at 5 a.m., 2 p.m., and 10 p.m. See CMS Ex. 1, at 95; CMS Ex.
13, at 23, 24.
10

December 29, 2010 - Petitioner administered 20 mg. of Oxycontin to
R10 at 5 a.m., 2 p.m., and 9 p.m. See CMS Ex. 1, at 95; CMS Ex.
13, at 23.

December 30, 2010 - Petitioner administered 20 mg. of Oxycontin to
R10 at 6 a.m., 2 p.m., and 9 p.m. See CMS Ex. 1, at 95; CMS Ex.
13, at 23, 24.

January 1, 2011 - Petitioner administered 20 mg. of Oxycontin to
R10 at 6a.m., 9 a.m., and 9 p.m. See CMS Ex. 1, at 95; CMS Ex.
13, at 23, 24, 25.

On the following date, Petitioner administered a double dose of Oxycontin to R10:

January 4, 2011 - 20 mg. of Oxycontin was administered to R10 at 6
a.m., and then two doses (40 mg. total) were administered at 9 p.m.
(R10’s order is for one 20 mg. tablet, not two). See CMS Ex. 1, at
95; CMS Ex. 13, at 23.

Moreover, the MAR and INR show that on the following dates, Petitioner failed to
administer to R10 his morning or evening does of Oxycontin, 20 mg., as prescribed:

December 15, 2010 - Petitioner failed to administer R10 his morning
dose.

January 3, 2011 - Petitioner failed to administer R10 his evening
dose.

January 5, 2011 - Petitioner failed to administer R10 his evening
dose.

January 6, 2011 - Petitioner failed to administer R10 his morning
dose.

CMS Exs. 1, at 96; 13, at 18, 21, 22, 23, 24, 25.

Irregularities also existed with respect to the administration of oxycodone. CMS notes
that staff wrote in the wrong medication name and strength at the top of some of R10’s
INR log sheets, so that, instead of writing “oxycodone 10 mg.,” they incorrectly wrote in
“Oxycontin 10 mg.” CMS Br. at 14. Under the nurse practitioner’s order, R10 was
supposed to receive 10 mg. of oxycodone by mouth every four hours as needed for pain.
However, the INR shows that staff did not follow this order.
11

The record reflects that Petitioner’s staff administered either too much oxycodone to R10
or administered it more frequently than ordered:

December 25, 2010 - Petitioner administered oxycodone, 20 mg., at
2p.m.. CMS Ex. 1, at 96; CMS Ex. 13, at 30.

December 27 and 31, 2010 - Petitioner administered two tablets of
oxycodone (10 mg. x 2 = 20 mg.), at 2 p.m. CMS Ex. 1, at 96; CMS
Ex. 13, at 30.

December 15 and 18, 2010 - Petitioner administered one dose of
oxycodone to R10 at 2 p.m. and another dose at 4 p.m., which is
every two hours, not every four hours as ordered. CMS Ex. 1, at 96;
CMS Ex. 13, at 28-29.

December 26, 2010, Petitioner administered two 10 mg. tablets of
oxycodone, instead of one, at | p.m., and again gave him two tablets
of oxycodone at 6 p.m. CMS Ex. 1, at 96; CMS Ex. 13, at 29.

January 4, 2011 - Petitioner administered two 10 mg. tablets of
oxycodone at 8 a.m. CMS Ex. 1, at 96; CMS Ex. 13, at 29.

Petitioner concedes that a transcription error occurred when a nurse mistakenly reentered
the old medication order for Oxycontin on R10’s December MAR, instead of entering the
nurse practitioner’s new December 1, 2010 order, which prescribed 20 mg. of Oxycontin
every twelve hours rather than every eight hours. P. Response at 20; see P. Ex. 1, at 9.
Petitioner, however, downplays this error and cites the statements DON Williams made
that it was not a “significant” medication error. According to Ms. Williams’ declaration,
the pharmacy correctly filled the December 1, 2010 Oxycontin order and delivered only
two 20 mg. doses of Oxycontin each day. Ms. Williams acknowledges that “[R10’s]
December MAR indicates that the Resident was administered three 20 mg. doses on most
days in December,” but then states that she “determined that the nurses actually were
administering two of the 10 mg. oxycodone tablets from the “PRN” (as needed) supply
on those days.” Ms. Williams states that she “also determined that our narcotic
reconciliation records correctly documented and accounted for every such dose.” P. Ex.
1, at 9. As a further attempt to justify that the error was not significant, Ms. Williams
contends that R10 did not suffer any harm because he “never actually received more
medication on any day in December than was permissible under the Nurse Practitioner’s
Orders.” P. Ex. 1, at 10.

Ms. Williams’ testimony alone is not enough to defeat CMS’s motion for summary
judgment. Although Ms. Williams refers to “narcotic reconciliation records” as proof
that every dose was “accounted for,” Petitioner has not indicated what these documents

12

are, nor has Petitioner proffered them as evidence. Therefore I do not have to accept her
unsupported and unreasonable inference as true for summary judgment purposes. See
Brightview Care Ctr., DAB No. 2132, at 10.

CMS has offered Petitioner’s own records in support of findings that the surveyors made
based on review of those records documenting that Petitioner’s staff made multiple errors
in the administration of Oxycontin, 20 mg., and oxycodone, 10 mg., to R10. On some
days, R10 received too many doses of these medications. On other days, R10 did not
receive the correct number of doses. Other than the declaration of Ms. Williams, who
concedes some errors, Petitioner has not come forward with any evidence establishing a
dispute over any of the facts set forth in the MAR and INR documentation regarding the
administration of Oxycontin and oxycodone during the relevant time frame. The only
reasonable inference for me to draw is that Petitioner’s staff did not dispense and
administer Oxycontin and oxycodone to R10 in accordance with the nurse practitioner’s
orders.

Despite the DON’s conclusion that Petitioner’s errors were not significant, Petitioner’s
own training documents recognize that Oxycontin and oxycodone must be properly
administered and closely regulated. A training document for nursing staff from January
2010 states, among other instructions, “Oxycodone and Oxycontin are 2 different
medications. They are the same drug type but Oxycontin is long acting and oxycodone is
short acting. They CANNOT be interchanged.” The document also states that
“[nJarcotics are to be counted at the end of your shift with oncoming nurse.” CMS Ex.
13, at 35.

The Mayo Clinic states the following regarding oxycodone:

Do not take more of it, do not take it more often, and do not
take it for a longer time than your doctor ordered. This is
especially important for elderly patients, who may be more
sensitive to the effects of pain medicines. If too much of this
medicine is taken for a long time, it may become habit-
forming (causing mental or physical dependence).

CMS Ex. 14, at 10. Regarding missed doses, the Mayo Clinic states, “[i]f you miss a
dose of this medicine, take it as soon as possible. However, if it is almost time for your
next dose, skip the missed dose and go back to your regular dosing schedule. Do not
[take] double doses.” CMS Ex. 14, at 12.

The fact that Petitioner alleges R10 did not suffer any actual harm does not precludemy
finding it out of substantial compliance with participation requirements. For a facility to
be found not in “substantial compliance” with participation requirements, all that is
required is a finding that the deficiency has the potential for more than minimal harm. 42
13

C.F.R. §§ 488.301, 488.402(c), 488.430(a). Here, Oxycontin and oxycodone are
powerful narcotic pain medications that can pose serious risks to a resident’s health and
safety if improperly administered. As Schedule II narcotics having strong potential for
abuse or addiction, they are controlled substances subject to additional regulations that do
not apply to other medications. 42 C.F.R. § 483.60(b)(2), (3), and (e)(2). With
controlled substances, facilities must establish a system to ensure that their receipt and
disposition is recorded with sufficient detail to enable an accurate reconciliation and have
an account of all controlled drugs that is maintained and periodically reconciled. 42
C.F.R. § 483.60(b)(2), (3). Additionally, a facility must provide separately locked,
permanently affixed compartments for storage of Schedule II controlled drugs and other
drugs subject to abuse, except when the facility uses single unit package drug distribution
systems where the quantity is minimal and missing doses can be readily detected. 42
C.F.R. § 483.60(e)(2).

The errors by Petitioner’s staff clearly had the potential for more than minimal harm.
The improper administration of these powerful narcotics could potentially have led to
serious complications, including dependency issues and untreated pain symptoms for
R10. For the purposes of this deficiency, even if Petitioner were to have shown it
administered the narcotics to R10 as ordered, its consistent failure to have accurate and
reconciled documentation of what narcotic was administered, and when, also constitutes
a violation under this regulation.

Resident 32

R32 was a 75-year-old woman diagnosed with hypertension, heart disease, schizophrenia,
periodic fainting, and chronic fatigue. CMS Ex. 16, at 7. She regularly took almost two
dozen medications. CMS Ex. 16, at 7, 9.

CMS alleges support for a deficiency under 42 C.F.R. § 483.60(a) and (b) because R32’s
records reflect missing doses of Acular, Spiriva, and Zestril. Acular is used to treat itchy
eyes caused by allergies. It is also used to treat swelling and redness that can occur after
cataract surgery. CMS Ex. 17. Spiriva is inhaled medication used to prevent wheezing,
shortness of breath, and difficult breathing in patients with chronic obstructive pulmonary
disease. CMS Ex. 21. Zestril is a blood pressure medication. CMS Br. at 15; P. Ex. 1, at
11.

R32 had physician orders originally dated November 4, 2010, for Acular eye drops
administered twice a day, every day, to the right eye; for a Spiriva inhaler, one puff once
a day, every day; and for Zestril, one tablet by mouth once a day, every day. CMS Ex. 1,
at 99, 101; CMS Ex. 16, at 7. According to R32’s January 2011 MAR, Acular was not
given as prescribed on January 3-5, 2011. CMS Ex. 1, at 100; CMS Ex. 16, at 30. On
January 3, 2011, R32 was not provided the 9 a.m. dose of Acular. Although R32 was
provided her 5 p.m. dose as prescribed, she was not provided the medication at all on
14

January 4 and 5. CMS Ex. 1, at 100; CMS Ex. 16, at 30. The MAR also indicates that
Spiriva was not administered to R32 on January 4, 2011. CMS Ex. 1, at 100; CMS Ex.
16, at 27. With respect to Zestril, R32’s MARs show that she received this medication
once a day from November 5-12, 2010 (CMS Ex. 16, at 19), then did not receive it again
until January 1, 2011 (CMS Ex. 16, at 10, 27-28). R32 then did not receive Zestril again
from January 2-5, 2011, even though the order for daily administration was renewed
monthly. CMS Ex. 16, at 27-28. According to the SOD, a nurse had mistakenly noted on
the MAR that R32’s Zestril was discontinued. CMS Ex. 1, at 100-01.

In addition, CMS alleges that R32’s records show that Petitioner administered R32 too
many doses of Zocor, a medication to control high levels of cholesterol in the blood. R32
was supposed to receive Zocor on Mondays, Wednesdays, and Fridays, as her prescriber
ordered, but Petitioner’s staff documented that Zocor was administered every day. CMS
Ex. 1, at 102-03.

Petitioner has conceded that some pharmaceutical errors occurred. In a Medication Error
Reporting Form dated January 1, 2011, Petitioner’s staff stated that Acular and Spiriva
were not given to R32 because the facility ran out of these medications. Staff also noted
that these medications were ordered too late. CMS Ex. 16, at 5. Another Medication
Error Reporting Form, dated January 4, 2011, states that Petitioner did not administer
Zestril to the resident from November 12 through December 31, 2010, nor did Petitioner
administer it on January 2 and 3, 2011. The form indicates also that Petitioner
administered Zocor to R32 every day from November 5 through November 30, 2010,
when it was supposed to be administered only on Mondays, Wednesdays, and Fridays.
CMS Ex. 16, at 4. Staff noted that there was a documentation error that started as a
transcription error. In explaining these errors, Petitioner’s staff wrote on the form,
“[njurse yellowed out Zestril by mistake. Zestril was just above Zocor and Zocor was
rewritten on the day Zestril was yellowed out. [I] [feel the nurse yellowed Zestril by
mistake. End of month order check did NOT catch this mistake.”” CMS Ex. 16, at 4.

Petitioner’s DON, Ms. Williams, concedes that staff made several errors with respect to
R32’s medications. P. Ex. 1, at 11. However, she asserts that none of the errors harmed,
or had the potential to cause more than minimal harm to R32, and that the errors “plainly
represent human errors and do not reflect some inadequacy in Petitioner’s pharmacy

* Petitioner asserts that it is universally recognized that highlighting an order in yellow
means that the order has been discontinued. P. Br. at 23.
15

systems”. ° Id. at 12.

Although Ms. Williams admits that “Zocor continued to be administered per the now-
incorrect MAR every day through November,” she claims that the December MAR
correctly showed “X’s” in the boxes for Sunday, Tuesday, Thursday, and Saturday,
indicating that Zocor was to be administered only on Mondays, Wednesdays, and
Fridays, and that Zocor was, in fact, administered correctly in December. See P. Ex. 13,
at 1. Ms. Williams states further that a nurse who noticed that the phrase “at bedtime”
had been incorrectly written in the Zocor box intended to correct this error, but instead
mistakenly highlighted in yellow the order for Zestril, which is above the order for Zocor
on the MAR. As a result, nursing staff believed that Zestril had been discontinued and
stopped administering this medication to R32 through December. Ms. Williams stated
that this error was caught and corrected before the survey. According to Ms. Williams,
“there is no indication that too much Zocor or too little Zestril caused any harm to [R32]”
(P. Ex. 1, at 12; P. Ex. 15), and she claims that she confirmed that R32’s blood pressure
remained under control even though she did not receive Zestril for several weeks. P. Ex.
1, at 12.

As for the alleged missed doses of Acular and Spiriva, Ms. Williams questions whether
is was actually the case based on R32’s MAR. P. Ex. 1, at 13. She acknowledges that
i MAR does reflect that R32 did not receive some doses of Acular during January 1-5,

011, but she claims that it also shows that some doses were administered, which would

uggest that Acular was not unavailable. P. Ex. 1, at 13. Ms. Williams concedes that, on

anuary 4, 2011, one dose of Spiriva was missed but gave no reason to explain why, and

ere were no missed doses documented in December 2010 or January 2011.

bog

aan

For summary judgment purposes, I accept Ms. Williams’ claims as true. However, her
statements, even when interpreted in a light most favorable to Petitioner, do not dispute
CMS’s allegations that Petitioner’s staff committed numerous pharmaceutical errors with
respect to R32. Petitioner has conceded that its staff made numerous pharmaceutical
errors: R32 received more Zocor than she was prescribed; she received less Zestril than
she was prescribed (in fact, it was discontinued for several weeks); and, on certain dates,
she did not receive her prescribed doses of Spiriva and Acular because the facility ran out
of the medication. It is clear that Petitioner’s pharmacy system was not accurate in

> While Petitioner concedes that there were medication errors, it consistently attempts to
analyze them under the requirements of section 483.25(m) and not the pharmaceutical
deficiency at issue here under section 483.60. Nonetheless, the Board has found that it is
a facility’s burden under 483.60(a) to rebut CMS’s showing that a drug was not available
to a resident who was taking it regularly. See Western Care Management Corp., d/b/a
Rehab. Specialties Inn, DAB No. 1921 (2004).

16

assuring that its residents received medications as ordered and required to meet their
needs.

Moreover, I reject Ms. Williams’ conclusions that none of Petitioner’s pharmaceutical
errors harmed or had the potential for causing more than minimal harm to R32. To the
contrary, R32 could have experienced adverse effects and potentially serious harm as a
result of Petitioner’s staff’s failure to give her the medications she had been prescribed.
For example, she could have untreated symptoms including breathing problems from a
missed dose of Spiriva and increased blood pressure due to missing Zestril from
November 12 through December 31, 2010, and on January 2 and 3, 2011. With respect
to Zocor, R32 could have suffered serious adverse effects from the fact that she received
it every day instead of her prescribed dose, which was only on Mondays, Wednesdays,
and Fridays. Zocor is a prescribed drug, and the Mayo Clinic warns that one of its side
effects may include difficulty with breathing. CMS Ex. 24, at 7. Especially considering
R32 was prescribed Spiriva for existing breathing problems, this error had the potential
for causing more than minimal harm.

In Petitioner’s view, the pharmaceutical errors resulted from “human errors” and not
from inadequacies in Petitioner’s pharmacy system. P. Br. at 15 and 17. As noted in
Barn Hill Care Ctr., DAB No. 1848, at 18 (2002), the regulatory requirements offer no
“human error” exception:

Indeed, it is difficult to imagine any deficiency that is not, at its core,
attributable to “human error.” A facility, therefore, puts in place
systems that minimize the chance for “human error.”

As with R10, Petitioner’s staff committed multiple pharmaceutical errors with respect to
R32 and these errors establish that Petitioner failed to ensure that systems were in place
to accurately dispense and administer drugs to meet R32’s needs, in violation of 42
C.F.R. § 483.60(a) and (b). Additionally, Petitioner failed to have a system in place to
reorder prescribed medications, and it failed to promptly remedy this situation. These
errors had the potential for more than minimal harm to both R10 and R32. Based on the
undisputed facts above, I find that Petitioner was not in substantial compliance with 42
C.F.R. § 483.60(a) and (b).

C. CMS is entitled to summary judgment that Petitioner was not in substantial
compliance with 42 C.F.R. § 483.75()(1) because the undisputed evidence
establishes Petitioner did not maintain clinical records on R8, R10, and R32 that
were complete and accurately documented.

42 C.F.R. § 483.75(1)(1) requires a facility to maintain clinical records on each resident,
in accordance with accepted professional standards and practices that are complete,
accurately documented, readily accessible, and systematically organized.
17

CMS principally relies on the same facts that I have already discussed for the deficiencies
under 42 C.F.R. §§ 483.25 and 483.60(a) and (b). With respect to R8, CMS cites the
inaccurate and incomplete facility records created when Petitioner administered Haldol to
the resident. CMS Ex. 1, at 115, 125-26. With respect to R10’s clinical record, CMS
refers to the missed doses and other errors relating to the administration of Oxycontin and
oxycodone. CMS Ex. 1, at 115-20. As for R32’s record, CMS cites the missed doses of
Acular, Spiriva, and Zestril, as well as the fact that the resident received too many doses
of Zocor. CMS Ex. 1, at 120-24.

CMS alleges also that R8’s records regarding receipt of the drug Remeron, used to treat
depression, were not accurate. CMS Ex. 1, at 115. According to the SOD, R8 hada
physician’s order, dated December 28, 2010, for 7.5 mg. of Remeron every evening.
However, staff transcribed this order as “75” mg., not “7.5” mg. and entered “Remeron
75 mg.” every evening on the December 2010 and January 2011 MAR. As alleged in the
SOD, Petitioner’s staff initialed the administration of 75 mg. of Remeron every night to
R8 from December 29, 2010. CMS Ex. 1, at 124-25. CMS notes, however, that
according to the SOD, Petitioner’s staff apparently did provide the correct dose by cutting
15 mg. tablets of Remeron in half. CMS Ex. 1, at 125; CMS Br. at 18.

In its hearing request, Petitioner acknowledges that errors existed in the medical records,
but attempts to attribute any discrepancies to “software glitches.” P. Hearing Request at
12. To support its assertion that none of the errors in the medical records constitute a
violation of 42 C.F.R. § 483.75(1)(1), Petitioner points to DON Williams’ statements that
clinical records are to serve as “ongoing guidance to the variety of caregivers who
interact with each resident over time . . . and a historical record of the resident’s
condition, status... over time.” P. Response at 26; P. Ex. 1, at 13-14.

As already discussed above with the other two deficiencies, the undisputed evidence
shows that the clinical records of R8, R10, and R32 were neither complete nor accurate
and contained significant documentation errors. With respect to R10 and R32,
Petitioner’s staff committed numerous documentation errors in their medication records,
which resulted in missed doses, under-dosing, and excessive doses.

R8’s records were not accurate or complete because Petitioner did not monitor R8 to
assure the Haldol was effective in treating R8’s symptoms or for adverse effects. The
alleged readmission assessment that NP Lockwood conducted is also not contained in
R8’s clinical record. Further, the MAR reflects that R8 was only provided Haldol from
December 14-28 and December 30-31, 2010. CMS Ex. 7, at 32. Although Petitioner
argues that R8 medically required Haldol upon readmission through January 6, 2011,
when NP Lockwood discontinued it, there is no evidence, either in the MAR or in the
progress or nursing notes, that Petitioner administered Haldol to R8 on December 13,
December 29, or at any time in January. Nor does the record contain any explanation as

18

to whether the Haldol was provided as ordered, and not documented, or whether it
simply was not provided at all. See CMS Ex. 7.

Petitioner failed to maintain clinical records on R8, R10, and R32 that were complete
and accurately documented. The inaccurate, incomplete, and error-filled records had the
potential for causing more than minimal harm to R8, R10, and R32, as I previously
discussed for the underlying deficiencies. Based on the undisputed facts above, I find
that Petitioner was not in substantial compliance with 42 C.F.R. § 483.75(I)(1).

D. The penalty CMS imposed is reasonable.

I next consider whether the CMP is reasonable by applying the factors listed in 42 C.F.R.
§ 488.438(f): 1) the facility’s history of noncompliance; 2) the facility’s financial
condition; 3) factors specified in 42 C.F.R. § 488.404; and 4) the facility’s degree of
culpability, which includes neglect, indifference, or disregard for resident care, comfort,
or safety. The absence of culpability is not a mitigating factor. The factors in 42 C.F.R.
§ 488.404 include: 1) the scope and severity of the deficiency; 2) the relationship of the
deficiency to other deficiencies resulting in noncompliance; and 3) the facility’s prior
history of noncompliance in general and specifically with reference to the cited
deficiencies.

Unless a facility contends that a particular regulatory factor does not support the CMP
amount, the ALJ must sustain it. Coquina Center, DAB No. 1860 (2002). In its hearing
request, Petitioner simply makes a general assertion that it “specifically challenges the
amount of the CMP.” P. Hearing Request at 13. However, in its response in opposition
to CMS’s motion for summary judgment, Petitioner provides no further information or
details as to the basis of this challenge. Petitioner does not contest the length of time
during which CMS imposed the CMP or claim that its financial condition affects its
ability to pay.

As previously noted, I find that the administration of unnecessary drugs violation (42
C.F.R. § 483.25(1)) alone justifies the amount of the CMP. Administering an
antipsychotic drug without adequate monitoring in an elderly patient for an extended
period of time is a serious deficiency, for which I find the facility culpable. The
additional violations further support the $700 per day CMP imposed from January 12
through February 14, 2011.

I note that the $700 penalty is at the lower end of the lower range of penalties, which
varies from $50 - $3,000. 42 C.F.R. § 488.438(a)(1)(ii). Further, the facility has a long
history of noncompliance. In the past two years alone, various surveys of Petitioner —
annual health certification surveys, complaint surveys, and Life Safety Code surveys —
have resulted in findings of numerous deficiencies. CMS Ex. 27. Among other surveys
finding deficiencies, a December 10, 2009 annual recertification survey resulted in a
19

finding of immediate jeopardy under Tag F323 (accidents and supervision) for which
Petitioner was assessed a CMP of $11,400. CMS Ex. 27, at 3. I note that at a complaint
survey conducted on April 7, 2009, Petitioner was cited, among other things, for failing
to be in substantial compliance with Tag F425 (pharmacy services), at the “D” level of
scope and severity. CMS Ex. 27, at 4. This tag is one of the deficiencies discussed
above. Petitioner has thus demonstrated repeated noncompliance under Tag F425, a fact
that supports an aggravated penalty amount.

For the reasons set forth above, I grant summary judgment in favor of CMS and find that
the remedy imposed is reasonable.

/s/
Joseph Grow
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Candace Lynn Reid,
Petitioner,
v.
The Inspector General.
Docket No. C-12-22
Decision No. CR2503

Date: February 22, 2012

DECISION

This matter is before me on the Inspector General's (I.G.’s) Motion for Summary
Disposition affirming the I.G.'s determination to exclude Petitioner Candace Lynn Reid
from participation in Medicare, Medicaid, and all other federal health care programs for a
period of five years. The L.G.'s Motion and determination are based on section
1128(a)(2) of the Social Security Act (Act), 42 U.S.C. § 1320a-7(a)(2), and arise from
Petitioner’s state court conviction of an offense relating to patient neglect or abuse. As I
shall explain below, the undisputed facts in this case require the imposition of the five-
year exclusion. For that reason, I grant the I.G.'s Motion for Summary Disposition.

I. Procedural Background

In 2009 Petitioner Candace Lynn Reid was employed as a caregiver at an adult foster
care facility known as Progressive Habilitative Services and located in suburban
Minneapolis, Minnesota. At some time prior to November of that year Petitioner formed
an attachment to one of the male residents identified here as R.M., whose diagnoses
included brain damage to the hippocampus and frontal lobe, mild mental retardation, and
histories of attention deficit disorder and intermittent explosive disorder. Eventually that
attachment took on the dimension of an intimate sexual relationship conducted by
Petitioner and R.M. in his bed at the facility. Authorities learned of this activity, and on
February 10, 2010 Petitioner was charged with the gross misdemeanor offense of Abuse
of a Vulnerable Adult, in violation of MINN. STAT. §§ 609.2325.1(b) and 2325.3(b).

On July 16, 2010, Petitioner appeared with counsel in the District Court, Fourth Judicial
District, County of Hennepin, Minnesota. She appeared there to plead guilty to the
charge, and did so after executing a lengthy and comprehensive Petition to Enter Plea of
Guilty.

Petitioner’s plea was acted upon by the District Court, which over the prosecution’s
objection ordered a stay of adjudication for twelve months and seven days, and placed
Petitioner on probation subject to conditions including a “no-contact” condition barring
contact between R.M. and Petitioner. Petitioner was required to pay $100.00 costs of
prosecution.

Section 1128(a)(2) of the Act dictates the mandatory exclusion, for a term of not less than
five years, of “[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.” The LG. notified Petitioner of her exclusion

for the mandatory minimum period of five years on August 31, 2011.

Acting through counsel, Petitioner timely sought review of the I.G.’s action on October 3,
2011. I convened a telephonic prehearing conference on November 2, 2011, pursuant to
42 C.F.R. § 1005.6, in order to discuss the issues presented by the case and the
procedures best suited for addressing them. The parties agreed that the case likely could
be decided on written submissions, and I established a schedule for the submission of
documents and briefs. The details of the conference and the schedule established in it are
set out in my Order of November 3, 2011. All briefing is now complete, and for purposes
of 42 C.F.R. § 1005.20(c), the record closed February 3, 2012.

There are eight exhibits in this case. The LG. has proffered I.G.’s Exhibits 1-6 (1.G. Exs.
1-6); Petitioner has not objected to these exhibits, and they are admitted. Petitioner has
proffered Petitioner’s Exhibits 1 and 2 (P. Exs. 1 and 2) to which objections have been
made by the LG. Although there is some validity to the I.G.’s objections, I cannot see the
admission of those proffered Petitioner’s Exhibits as having the slightest prejudicial
effect on the I.G.’s position in this case. Accordingly, P. Exs. 1 and 2 are admitted.

IL. Issues

The legal issues before me are limited to those set out at 42 C.F.R. § 1001.2007(a)(1). In
the specific 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)(2) 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. Section 1128(a)(2) of the
Act mandates Petitioner’s exclusion since her predicate conviction has been established.
A five-year period of exclusion is the minimum period established by section
1128(c)(3)(B) of the Act, 42 U.S.C. § 1320a-7(c)(3)(B), and is therefore reasonable as a
matter of law.

III. Controlling Statutes and Regulations

Section 1128(a)(2) of the Act, 42 U.S.C. § 1320a-7(a)(2), requires the exclusion from
participation in Medicare, Medicaid, and all other federal health care programs of 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.” The terms of section 1128(a)(2) are restated in regulatory language
at 42 C.F.R. § 1001.101(b). 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 ... by a... State... court,” section 1128(i)(2) of the Act; “when a
plea of guilty . . . by the individual . . . has been accepted by a... State . . . court,”
section 1128(i)(3) of the Act; or “when the individual . . . has entered into participation in
a... deferred adjudication ... program where judgment of conviction has been
withheld,” section 1128(i)(4) of the Act. 42 U.S.C. §§ 1320a-7(i)(1)-(4). These
definitions are repeated at 42 C.F.R. § 1001.2.

MINN. STAT. § 609.2325.1(b) defines the crime of Abuse of a Vulnerable Adult in
these terms:

(b) A caregiver, facility staff person, or person providing services ina
facility who engages in sexual contact or penetration, as defined in
section 609.341, under circumstances other than those described in
sections 609.342 to 609.345, with a resident, patient, or client of the
facility is guilty of criminal abuse and may be sentenced as provided in
subdivision 3.
An exclusion based on section 1128(a)(2) 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 July 16, 2010 in the District Court, Fourth Judicial District, County of Hennepin,
Minnesota, Petitioner Candace Lynn Reid pleaded guilty to one count of the gross
misdemeanor criminal offense of Abuse of a Vulnerable Adult, in violation of MINN.
STAT. §§ 609.2325.1(b) and 609.2325.3(b). IG. Exs. 5, 6.

2. In response to Petitioner’s plea of guilty, the District Court ordered Petitioner to pay
the costs of prosecution in the sum of $100.00, imposed conditions of probation including
a “no-contact” condition barring contact between R.M. and Petitioner, and stayed the
adjudication of the remaining proceedings for 12 months and seven days. I.G. Exs. 5, 6;
P. Ex. 1, at 11, 13.

3. The proceedings described above in Findings 1 and 2 constitute a “conviction” within
the meanings of sections 1128(a)(2) and 1128(i)(3) and (4) of the Act, and 42 C.F.R.
§ 1001.2.

4. There is a nexus and a common-sense relationship between the criminal offenses of
which Petitioner was convicted, as noted above in Findings | and 2, and the neglect or
abuse of a patient in connection with the delivery of a health care item or service. LG.
Exs. 3, 4, 5; P. Ex. 1.

5. Petitioner’s conviction of a criminal offense relating to neglect or abuse of a patient in
connection with the delivery of a health care item or service constitutes a basis for the
1.G.’s exclusion of Petitioner from participation in Medicare, Medicaid, and all other
federal health care programs. Section 1128(a)(2) of the Act; 42 U.S.C. § 1320a-7(a)(2).

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

7. There are no disputed issues of material fact and summary disposition is therefore
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)(2) of
the Act are: (1) the individual to be excluded must have been convicted of a criminal
offense; (2) the conviction must have been related to the neglect or abuse of patients; and,
(3) the patient neglect or abuse to which an excluded individual's conviction related must
have occurred in connection with the delivery of a health care item or service. Bruce
Lindberg, D.C., DAB No. 1280 (1991); Neitra Maddox, DAB CR1218 (2004); Maureen
T. Kehoe, DAB CR673 (2000); Gabriel S. Orzame, M.D., DAB CR587 (1999); Ann M.
MacDonald, DAB CR519 (1998); Anthony A. Tommasiello, DAB CR282 (1993).

The parties’ pleadings do not argue the second and third elements. Petitioner does not
contest that the crime to which she pleaded guilty was related to the abuse, as that term is
lefined by Minnesota statute, of the impaired man with whom she became sexually
intimate. While Petitioner claims that R.M. “benefitted and saw his life affirmed and
enhanced in a significant way,” she also concedes that her crime constituted “abuse of a
patient as defined by Minnesota Statute and the Act.” P. Ans. Br., at 7. Nor does she
leny that the incident occurred while R.M. was in her care. I note, however, that both
these elements are established by the investigation that led to the charges filed on
February 10, 2010, and by the language of the charges themselves. I.G. Exs. 3, 4, 5.

The parties’ arguments in this case focus on the first element. Petitioner asserts that the
stayed adjudication of her tendered guilty plea does not, under Minnesota state law,
support the .G.’s determination to treat it as a predicate “conviction” under the federal
exclusionary statute. The I.G. relies on a long line of precedent to argue that Petitioner
has been convicted for purposes of this federal litigation, and that the stayed adjudication
of her guilty plea cannot operate to invalidate it as a predicate “conviction” under federal
law.

Petitioner has provided no citations to Minnesota statutes or to Minnesota rules of
criminal procedure that might permit an extended analysis of her position. The only
reference to the authority relied on by the District Court appears in the noticeably-
incomplete transcript of the proceedings on July 16, 2010, where the term “stay of
adjudication” or a variant appears. P. Ex. 1, at 5, 7,9, 11, 14, and 15. There is,
moreover, an evidentiary gap in Petitioner’s position: in her Answer Brief, she asserts as
a fact that her year-long probationary period was successfully completed on or about
August 16, 2011. P. Ans. Br., at 4. An attachment to her October 3, 2011 Request for
Hearing appears to be the District Court’s docket sheet or register of actions reflecting an
amended disposition on August 17, 2011. That document, or the purported order of
August 17, 2011, might lend support to her factual assertion if they were elucidated by
some explanation or if they were part of the evidentiary record, which by the explicit
terms of paragraph 7 of my November 3, 2011 Order they are not. As matters stand, no
order of dismissal appears in the evidence before me; for purposes of this Decision,

however, I shall assume arguendo that an order of discharge from probation and
dismissal of the charge of some sort was eventually entered, and that it entitled Petitioner
to the form of relief under Minnesota law she now claims.

The prosecution opposed the stay of adjudication, and expressed its preference to a stay
of imposition of sentence, pursuant to MINN. STAT. § 609.135. But whatever the
incomplete transcript of the proceedings on July 16, 2010 may reveal, it is clear that
Petitioner’s guilty plea was accepted to the extent necessary to allow the District
Court to place her on probation for a year, order that she pay $100.00 in costs of
prosecution, and impose the strict provision barring contact between Petitioner and
the man whom she abused. '

Without more information on the legal authority relied on by the District Court for the
stay of adjudication, and its specific application in Petitioner’s prosecution, those
questions remain obscure, but they are not critical to this discussion. Instead, the
established law of this forum requires that the Act’s definitions of “conviction” be
applied in these circumstances. Ellen L. Morand, DAB No. 2436 (2012); Henry L.
Gupton, DAB No. 2058 (2007), aff'd sub nom. Gupton v. Leavitt, 575 F. Supp. 2d 874
(E.D. Tenn. 2008); Marc Schneider, D.M.D., DAB No. 2007 (2005); Carolyn Westin,
DAB No. 1381 (1993), aff'd sub nom. Westin v. Shalala, 845 F.Supp. 1446 (D. Kan.
1994); see Bethany Anne Winther-Galimore, DAB CR2501 (2012); Myrna Baptista,
DAB CR2410 (2011); Theresa A. Bass, DAB CR1397 (2006). Those specific definitions
noted in sections 1128(i)(3) and 1128(i)(4) of the Act encompass the proceedings against
Petitioner. By the federal definitions applicable in this federal litigation aimed at
protecting the integrity of federal health care programs, the criminal proceedings against

' The extended colloquy among prosecution, defense, and the District Judge does not
clarify the legal theory underlying the stay of adjudication. The incomplete transcript of
that colloquy, and several spelled-out references in it, mention a 1996 Minnesota
Supreme Court decision called “Krautzer.” P. Ex. 1, at 6,7, 9. Petitioner cites that case
in her brief as “State v. Krautzer, 548 NW2d252(MN 1996)[sic].” P. Ans. Br. at 6. All
of these references appear to be intended citations of State v. Billy Jim Krotzer, 548
N.W.2d 252 (Minn. 1996). That case dealt with the inherent powers of Minnesota courts
to remedy what they might perceive as the overly-harsh consequences of a conviction by
staying the adjudication of criminal charges under very special circumstances. The
relevance of Krotzer to this case is uncertain, but even if applied vigorously in Minnesota
courts, Krotzer is an example of precisely what the Board meant when it wrote, in
Carolyn Westin, DAB No. 1381 (1993), aff'd sub nom. Westin v. Shalala, 845 F. Supp.
1446 (D. Kan. 1994): “Congress has defined for the ALJ and this Board what
‘convicted’ means for purposes of section 1128 and that definition is binding on us.
Moreover, it is clear from the legislative history of this provision that Congress adopted
such broad definitions to ensure that exclusions from federally funded health programs
would not hinge on state criminal justice policies.” Westin, at 6.

Petitioner ended in her “conviction” as charged on July 16, 2010. This issue has been
debated in this forum and before the Departmental Appeals Board (Board) for nearly two
decades, and the resolution of the issue has never varied. The Administrative Law Judges
(ALJs) of this forum and appellate panels of the Board have frequently addressed
petitioners’ arguments that they should not be regarded here as “convicted” because they
are not considered “convicted” under state law. The Board panels and ALJs of this forum
have consistently rejected those arguments for the reason that federal law — specifically
section 1128(i) of the Act — and not state laws, governs the meaning of “convicted” in
applying the terms of the Social Security Act.

Because the I.G. has established a basis for Petitioner’s exclusion pursuant to section
1128(a)(2), her exclusion for five years is mandatory pursuant to section 1128(c)(3)(B) of
the Act. 42 U.S.C. § 1320a-7(c)(3)(B). That period is reasonable as a matter of law.

Summary disposition is authorized by the terms of 42 C.F.R. § 1005.4(b)(12). Resolution
of a case by summary disposition is particularly fitting when settled law can be applied to
undisputed material facts. Marvin L. Gibbs, Jr., M.D., DAB No. 2279 (2009); Michael J.
Rosen, M.D., DAB No. 2096 (2007). The material facts in this case are undisputed and
unambiguous. They support summary disposition as a matter of settled law, and this
Decision issues accordingly.

VI. Conclusion

For the reasons set out above, the I.G.’s Motion for Summary Disposition is GRANTED.
The I.G.’s exclusion of Petitioner Candace Lynn Reid 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)(2) of the Act, 42 U.S.C. § 1320a-7(a)(2), is thereby
sustained.

/s/
Richard J. Smith
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Karen Karsif, M.D.,
(NPI: 1760433957),

Petitioner
v.
Centers for Medicare and Medicaid Services.
Docket No. C-11-777
Decision No. CR2502

Date: February 13, 2012

DECISION
I dismiss as untimely Petitioner’s hearing request in this matter.

Petitioner is not entitled to a hearing because she did not
file a timely hearing request, and no good cause justifies
extending the time for filing.’

The regulations governing these proceedings mandate that an affected party, who would
be entitled to a hearing under 42 C.F.R. Part 498, must file her request for hearing in
writing within 60 days of the day she receives notice of the determination that she wishes
to appeal, unless the appeal period is extended. 42 C.F.R. § 498.40(a)(2). On motion of
a party, or on his/her own motion, an Administrative Law Judge may dismiss a hearing
request that was not timely filed, if the time for filing was not extended. 42 C.F.R. §
498.70(c). Receipt of the notice is “presumed to be 5 days after the date on the notice
unless there is a showing that it was, in fact, received earlier or later.” 42 C.F.R. §§
498.40(a)(2), 498.22(b)(3).

'T make this one finding of fact/conclusion of law.
Here, Petitioner, Karen Karsif, M.D., applied for enrollment in the Medicare Part B
program. By letter dated May 5, 2011, the Medicare contractor, National Government
Services, Inc., approved her application, effective March 13, 2011. Petitioner Karsif
sought reconsideration, challenging the effective date. In a decision letter dated May 23,
2011, the contractor denied her request. The contractor’s letter included notice of
Petitioner’s appeal rights, advising: “You must file your appeal within 60 calendar days
after the date of receipt of this decision by writing ....” The letter then told her to
submit her appeal to this office and provided the address of the Civil Remedies Division
of the Departmental Appeals Board. The letter also referred her to 42 C.F.R. § 498 for an
explanation of her appeal rights.

Although Petitioner’s appeal letter has two dates on it -- July 27, 2011 and September 8,
2011 -- the document was postmarked September 9, 2011, and received in this office on
September 14, 2011, well after the regulatory filing deadline. Petitioner did not seek an
extension of time for filing her appeal. She did not suggest good cause justified late
filing.

In an order dated February 1, 2012, I directed Petitioner to show cause why this matter
should not be dismissed as untimely. I also directed the Centers for Medicare and
Medicaid Services (CMS) to explain its position on whether the appeal should be
dismissed as untimely filed. Order to Show Cause (Feb. 1, 2012).

CMS responded by noting that the “evidence available” does not establish that Petitioner
timely mailed her appeal. CMS asked that the matter be dismissed as untimely, citing 42
C.F.R. § 498.70(c). Petitioner responded: “We began our appeal process on 7/27/11 to
request a review of the denial we received regarding case: 225401113654295” (the case
number assigned to her application). Petitioner then repeats the argument she proffered
in her appeal letter. Petitioner does not explain what she did on July 27, 2011 that began
the appeals process. She does not claim that she mailed her appeal to this office, as
instructed by the notice letter. And no evidence suggests that she submitted her appeal
prior to September 9, 2011. Petitioner has not asked for an extension of time for filing
nor explained why an extension is warranted.

Because Petitioner did not file her hearing request within 60 days of receiving the
contractor’s notice letter, and no good cause justifies my extending the time for filing, I
dismiss Petitioner’s hearing request. 42 C.F.R. § 498.70(c).

/s/
Carolyn Cozad Hughes
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Bethany Anne Winther-Galimore and the Winther Family Chiropractic Center, LLC,
(O.I. File Number 7-08-40116-9),

Petitioner,
v.

The Inspector General.

Docket No. C-11-831

Decision No. CR2501

Date: February 13, 2012
DECISION

This matter is before me on the Inspector General’s (1.G.’s) Motion for Summary
Disposition affirming the I.G.’s determinations to exclude Petitioners Bethany Anne
Winther-Galimore and the Winther Family Chiropractic Center, LLC, from participation
in Medicare, Medicaid, and all other federal health care programs for a period of five
years. With respect to Petitioner Bethany Anne Winther-Galimore, the I.G.’s Motion and
determination are based on section 1128(a)(1) of the Social Security Act (Act), 42 U.S.C.
§ 1320a-7(a)(1). With respect to Petitioner Winther Family Chiropractic Center, LLC,
the I.G.’s Motion and determination are based on section 1128(b)(8) of the Act, 42
U.S.C. § 1320a-7(b)(8).
The undisputed facts of this case demonstrate that the five-year exclusion must be
imposed against each Petitioner, and that the length of each period of exclusion is not
unreasonable. Accordingly, I grant the I.G.’s Motion for Summary Disposition.

I. Procedural Background

In 2007 and 2008, Bethany Anne Winther-Galimore, a chiropractor, owned and operated
the Winther Family Chiropractic Center, LLC (WFCC), located in Camdenton, Missouri.
In February 2008 law enforcement officials began an investigation into Winther-
Galimore’s activities as they related to the Dove Senior Citizens Home in that
community. That investigation revealed that Winther-Galimore had billed the Medicare
program for chiropractic services that were not performed by her or received by several
residents of the Dove facility.

On July 22, 2009, in the Circuit Court of Camden County, Missouri, Winther-Galimore
was charged with the class C felony offense of stealing by deceit, in violation of Mo.
REV. STAT. § 570.030. On August 23, 2010, Winther-Galimore appeared in the Circuit
Court with counsel and tendered a plea of guilty to the charge. Her plea was accepted
and Winther-Galimore was adjudged guilty of the offense. Imposition of sentence was
suspended and Winther-Galimore was placed on probation for five years. As a condition
of probation, Winther-Galimore was required to pay an unspecified sum to what court
documents designate a “‘victim’s compensation judgment” and court costs.

On August 31, 2011, the I.G. notified Winther-Galimore that she was to be excluded
pursuant to the terms of section 1128(a)(1) of the Act for a period of five years. The I.G.
also sent a similar notice of exclusion for five years to WFCC on August 31, 2011, and in
that notice relied on the terms of section 1128(b)(8) of the Act.

Acting through counsel, Winther-Galimore and WFCC sought review of the I.G.’s
determinations in a joint request for hearing timely filed on September 26, 2011.

I convened a prehearing conference by telephone on October 26, 2011, pursuant to 42
C.F.R. § 1005.6, in order to discuss procedures for addressing the issues presented by this
case. By order of October 27, 2011 I established a schedule for the submission of
documents and briefs.

The evidentiary record on which I decide the issues before me contains 21 exhibits. The
1.G. proffered 12 exhibits marked I.G. Exhibits (I.G. Exs.) 1-12. Petitioners have jointly
proffered nine exhibits, marked Petitioners’ Exhibits (P. Exs.) 1-9. In the absence of
objection, I have admitted all proffered exhibits as designated by the offering party.

The record in this case closed for purposes of 42 C.F.R. § 1005.20(c) with the receipt of
Petitioners’ Notice of Intent Not to File Response Brief on February 2, 2012.

II. Issues

The legal 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:
a. Whether the LG. has a basis for excluding each Petitioner from
participating in Medicare, Medicaid, and all other federal health care
programs pursuant to sections 1128(a)(1) and 1128(b)(8) of the Act; and

b. Whether the length of each proposed period of exclusion is
unreasonable.

These issues must be resolved in favor of the I.G.’s position. Section 1128(a)(1) of the
Act mandates Petitioner Winther-Galimore’s exclusion for her predicate conviction has
been proven. A five-year period of exclusion is the minimum period established by
section 1128(c)(3)(B) of the Act, 42 U.S.C. § 1320a-7(c)(3)(B). Petitioner WFCC is
subject to the same period of exclusion by operation of the terms of section 1128(b)(8) of
the Act and 42 C.F.R. § 1001.1001(b)(1). The length of neither proposed period of
exclusion is unreasonable.

III. 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 convicted of a criminal offense related to the delivery of an item or
service under title XVIII of the Act (the Medicare program) or any state health care
program (the Medicaid program). The terms of section 1128(a)(1) are restated in similar
language at 42 C.F.R. § 1001.101(a). Section 1128(a)(1) does not distinguish between
felonies and misdemeanors as predicates for exclusion.

The Act defines “conviction” as including those circumstances “when a judgment of
conviction has been entered against the individual or entity... 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 or entity... bya... State. . . court,” section
1128(i)(2) of the Act; “when a plea of guilty or nolo contendere by the individual . . . has
been accepted bya... State... court,” section 1128(i)(3) of the Act; or “when the
individual . . . has entered into participation in a first offender, deferred adjudication, or
other arrangement or program where judgment of conviction has been withheld,” section
1128(i)(4) of the Act, 42 U.S.C. §§ 1320a-7(i)(1)-(4). These definitions are repeated at
42 CFR. § 1001.2.

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

Section 1128(b)(8) of the Act, 42 U.S.C. § 1320a-7(b)(8), authorizes the exclusion from
participation in Medicare, Medicaid, and all other federal health care programs of any
business entity that is owned, operated, or managed by, or has as its agent, any person

“who has been convicted of any offense described in subsection (a) of this section . . .”
or who has been excluded from a federal or state health care program. Exclusions under
section 1128(b) are permissive, and entities excluded under section 1128(b)(8) generally
must be excluded for the same period as the person whose relationship with the entity is

the basis for the exclusion. 42 C.F.R. § 1001.1001(b)(1).

The standard of proof is a preponderance of the evidence and there may be no collateral
attack of the conviction that is the basis for the exclusion. 42 C.F.R. § 1001.2007(c) and
(d). Petitioner bears the burden of proof and persuasion on any affirmative defenses or
mitigating factors and the LG. bears the burden on all other issues. 42 C.F.R. §
1005.15(b) and (c).

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

1. On July 22, 2009, in the Circuit Court of Camden County, Missouri, Petitioner
Bethany Anne Winther-Galimore was charged with the class C felony offense of stealing
by deceit, in violation of MO. REV. STAT. § 570.030. I.G. Ex. 7; P. Ex. 7.

2. On August 23, 2010, Petitioner Winther-Galimore appeared in the Circuit Court with
counsel and tendered a plea of guilty to the class C felony charge of stealing by deceit, in
violation of MO. REV. STAT. § 570.030. Her plea was accepted and Winther-Galimore
was adjudged guilty of the offense. 1I.G. Exs. 8, 9, 10; P. Ex. 8.

3. After accepting Petitioner Winther-Galimore’s plea of guilty and finding her guilty as
charged, the Circuit Court suspended imposition of sentence and placed her on probation
for five years, beginning on August 23, 2010. As a condition of her probation, Petitioner
was ordered to pay an unspecified amount in restitution and court costs. I.G. Exs. 9, 10;
P. Ex. 8.

4. The judgment of conviction, finding of guilt, and accepted plea of guilty described
above in Findings 2 and 3 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.

5. A nexus and a common-sense connection exist between the criminal offense of which
Petitioner Winther-Galimore was convicted, as noted above in Findings | and 2, and the
delivery of an item or service under the Medicare program. I.G. Exs. 3, 4, 7, 8; P. Exs. 3,
4,7, 8, 9; Berton Siegel, D.O., DAB No. 1467 (1994).

6. By reason of Petitioner Winther-Galimore’s conviction, a basis exists for the I.G.’s
exercise of authority, pursuant to section 1128(a)(1) of the Act, 42 U.S.C. § 1320a-
7(a)(1), to exclude her from participation in Medicare, Medicaid, and all other federal
health care programs.

7. Petitioner Winther-Galimore is the owner and agent of Petitioner WFCC. I.G. Exs. 3,
5,6, 11, 12; P. Exs. 1, 2,9.

8. Because Petitioner Winther-Galimore is the owner and agent of Petitioner WFCC, and
because of her conviction as noted above in Findings 1-6, a basis exists for the I.G.’s
exercise of authority, pursuant to section 1128(b)(8) of the Act, 42 U.S.C. § 1320a-
7(b)(8), to exclude Petitioner from participation in Medicare, Medicaid, and all other
federal health care programs.

9. The I.G.’s exclusion of each Petitioner for a period of five years is not unreasonable.
Findings 1-8 above.

10. There are no disputed issues of material fact and summary disposition is
therefore 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 Exclusion of Petitioner Winther-Galimore

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
(Medicaid). Tamara Brown, DAB No. 2195 (2008); Thelma Walley, DAB No. 1367;
Boris Lipovsky, M.D., DAB No. 1363 (1992); Lyle Kai, R.Ph., DAB CR1262 (2004),
rev'd on other grounds, DAB No. 1979 (2005), aff'd sub nom. Kai v. Leavitt, Civ. No.
05-00514 (D. Haw. July 17, 2006); see also Russell Mark Posner, DAB No. 2033, at 5-6
(2006). Those two essential elements are fully demonstrated in the evidence before me.

Winther-Galimore’s conviction is shown by I.G. Exs. 8, 9, and 10, and by P. Exs. 7 and
8. The Circuit Court’s acceptance of her guilty plea, its finding of her guilt, and its entry
of judgment of conviction on August 23, 2010 satisfied the definitions of “conviction” set
out at sections 1128(i)(1), 1128(i)(2), and 1128(i)(3) of the Act. The first essential
element is established by the record. I will discuss Winther-Galimore’s challenge to the
proof of this first element below.

The evidence also shows that Winther-Galimore’s conviction is related to the delivery of
an item or service under the Medicare program. Petitioner submitted fraudulent claims to
the Medicare program for chiropractic services she never performed. An extended
history of the investigation into Winther-Galimore’s abuse of the Medicare program
appears in I.G. Ex. 3 and P. Ex. 3. The detailed language of the charge to which she
pleaded guilty makes the connection explicit and both her statement to investigators and
her plea petition repeat the connection in her own handwriting. I.G. Exs. 7, 8; P. Exs. 4,
7, 8. The submission of false claims to the protected health care programs has been
consistently held to be a program-related crime within the reach of section 1128(a)(1).
Douglas Schram, R.Ph., DAB No. 1372 (1992); Dewayne Franzen, DAB No. 1165
(1990); Jack W. Greene, DAB No. 1078 (1989), aff’d sub nom. Greene v. Sullivan, 731
F. Supp. 835 (E.D. Tenn. 1990). I find the facts of Winther-Galimore’s crime
demonstrate the required nexus and common-sense connection between the crime and the
Medicare program. Berton Siegel, D.O., DAB No. 1467. The second essential element is
established by the record.

Winther-Galimore argues that certain provisions of Missouri law operate to keep the
definitions of “conviction” established by the Act from applying to her. She relies on
Mo. REV. STAT. § 610.105, a provision by which records of criminal proceedings can be
sealed — or, in the statute’s precise wording, “closed” — in certain circumstances, thus
barring those proceedings from forming the predicate for collateral actions in which a
prior Missouri conviction must be proven. The details of the Missouri statute and its
operation are not critical to this discussion.’ Instead, the established law of this forum
requires that the Act’s definitions of conviction be applied in these circumstances.
Ellen L. Morand, DAB No. 2436 (2012); Henry L. Gupton, DAB No. 2058 (2007), aff'd,
Gupton v. Leavitt, 575 F. Supp. 2d 874 (E.D. Tenn. 2008); Marc Schneider, D.M.D.,
DAB No. 2007 (2005); Carolyn Westin, DAB No. 1381 (1993), aff'd sub nom, Westin v.
Shalala, 845 F.Supp. 1446 (D. Kan. 1994); see Myrna Baptista, DAB CR2410 (2011);
Theresa A. Bass, DAB CR1397 (2006). Those definitions — noted in sections
1128(a)(1) and 1128(4)(1), 1128(i)(2), and 1128(i)(3) of the Act, and arguably in section
1128(i)(4) — encompass the proceedings against Witner-Galimore. By the federal
definitions applicable in this federal litigation aimed at protecting the integrity of federal
health care programs, the criminal proceedings against Winther-Galimore ended in her
conviction.

' It is true, as Winther-Galimore points out, that the disposition of her charges on August
23, 2010 left her eligible at some time in the future for the relief provided by MO. REV.
STAT. § 610.105. But even if Missouri criminal law governed this situation, the terms of
the statute are clear that the records of Winther-Galimore’s plea and adjudication of guilt
cannot be “closed until August 2015: “If ... imposition of sentence is suspended .. .
official records pertaining to the case shall thereafter be closed records when such case is
finally terminated.... MO. REV. STAT. § 610.105 (emphasis added). Presumably
Winther-Galimore understood that her records had not been closed and that her term of
probation would last until 2015 when she stipulated to those facts before the Missouri
State Board of Chiropractic Examiners. P. Ex. 9, at 3; LG. Ex. 4, at 3.
Winther-Galimore goes on to argue that if she must be excluded, that exclusion ought to
be based on the permissive authority granted to the I.G. in section 1128(b)(1) of the Act,
and should be for only three years, not for the minimum five-year period mandated by
section 1128(a)(1). She supports this argument with the claim that the charge to which
she pleaded guilty was a misdemeanor, not a felony, and that the shorter three-year term
is “appropriate because of mitigating circumstances” which she lists. P. Ans. Br. at 11-
3.

This argument abides comfortably neither with the facts of Winther-Galimore’s
conviction nor with the plain language of the statutes and regulations involved. As to the
facts, Winther-Galimore’s labored effort to cast her crime as a misdemeanor is belied by
the statement in her plea petition, written in her own hand: “I appropriated U.S.
currency, by billing for services which I did not perform. The total value . . . I received
was approximately $3300.” P. Ex. 8, at 2. It is further belied by her own stipulation, in
proceedings before the Missouri State Board of Chiropractic Examiners, that she pleaded
guilty “to the Class C Felony charge of Theft/Stealing by Deceit (value of property or
services $500 or more but less than $25,000), which constitutes a violation of Section
570.030, RSMo. ” P. Ex. 9, at 3; LG. Ex. 4, at 3.

But this argument and the considerable distortion of the record it incorporates are beside
the point for at least two reasons. First, section 1128(a)(1) makes no distinction between
misdemeanors and felonies as predicates for exclusion. A conviction based on either
class of criminal offense is sufficient predicate for an exclusion based on section
1128(a)(1). Craig Richard Wilder, DAB No. 2416 (2011); Lorna Fay Gardner, DAB
No. 1733 (2000); Tanya A. Chouke, R.N., DAB No. 1721 (2000); see Tamara Brown,
DAB CR1799 (2008). Second, once a conviction is shown to be within the reach of
section 1128(a), the mandatory operation of that section bars a petitioner from demanding
that the I.G. apply the terms of any part of section 1128(b), even in situations where the
underlying conviction could be argued to fall within section 1128(a) and one or more of
the provisions of sections 1128(b)(1)-(15). Craig Richard Wilder, DAB No. 2416;
Kenneth M. Behr, DAB No. 1997 (2005); Stacy Ann Battle, D.D.S, et al., DAB No. 1843
(2002); Lorna Fay Gardner, DAB No. 1733.

Although I have characterized the process of exclusion under section 1128(a)(1) as
mandatory, section 1128(c)(3)(B) of the Act, 42 U.S.C. § 1320a-7(c)(3)(B) provides that
“the Secretary may, after consulting with the Inspector General . . . waive the exclusion
under subsection (a)(1) ....” Such a waiver depends on a request from the administrator
of a federal or state health care program, and by the terms of 42 C.F.R. § 1001.1801(a)
must be in writing, must come from an individual directly responsible for administering
the program, and must assert that the individual for whom waiver is sought is a “sole
source” in the community. Significantly, both statute and regulation emphasize that the
decision to grant or deny a waiver is not reviewable here or elsewhere. Act, §
1128(c)(3)(B); 42 C.F.R. § 1001.1801(f).

Winther-Galimore has attempted to bring herself within the reach of this waiver
provision, although she cites the statutory provision incorrectly as 42 U.S.C. § 1320A-
7(B) and cites the regulation not at all. But her effort lacks the essential foundation of a
request from a program administrator, and it asserts facts insufficient to meet the “sole
source” requirement. Thus, even were the decision to grant or deny the waiver subject to
my review, I could hardy find an abuse of discretion in the denial of a request never
made, and if made, made on insufficient facts. Winther-Galimore is not entitled to a
waiver of her exclusion.

A survey of Winther-Galimore’s remaining arguments reveals that they present no basis
for overturning the I.G.’s action. She offers a series of factual assertions intended to be
“mitigating circumstances” as that term is used in section 1128(c)(3)(D) of the Act, but
since section 1128(c)(3)(D) applies only to certain permissive exclusions under section
1128(b) and not to this section 1128(a)(1) action, they are inapposite to this case. Nor are
they cognizable as mitigating factors in the sense comprehended by 42 C.F.R. §
1001.102(c), for the I.G. has not attempted to enhance the period of exclusion by
alleging any of the aggravating factors listed at 42 C.F.R. § 1001.102(b). Winther-
Galimore’s self-justifying assertions — that her crime was accidental, a mere business
mistake made during a time of physical and mental stress and made without the intent to
defraud Medicare, and that her guilty plea may have been based on an imperfect
understanding of its consequences — are all challenges that amount to collateral attacks
on her conviction. They are irrelevant here, for the regulations explicitly preclude any
collateral attack on Winther-Galimore’s conviction. “When the exclusion is based on the
existence of a criminal conviction . . . where the facts were adjudicated and a final
decision was made, the basis for the underlying conviction . . . is not reviewable and the
individual or entity may not collaterally attack it either on substantive or procedural
grounds, in this appeal.” 42 C.F.R. § 1001.2007(d); Joann Fletcher Cash, DAB No.
1725 (2000). “There is no reason to ‘unnecessarily encumber the exclusion process’ with
efforts to reexamine the fairness of state convictions.” Chander Kachoria, R.Ph., DAB
No. 1380, at 8 (1993).

Because the I.G. has established a basis for Petitioner Bethany Anne Winther-Galimore’s
exclusion pursuant to section 1128(a)(1), her exclusion for five years is mandatory
pursuant to section 1128(c)(3)(B) of the Act. 42 U.S.C. § 1320a-7(c)(3)(B). That period
is reasonable as a matter of law.
The Exclusion of Petitioner WFCC

The exclusion of a business entity based on section 1128(b)(8) of the Act, 42 U.S.C. §
320a-7(b)(8) is a derivative action. It depends first on a showing that a person has been
convicted of an offense described in sections 1128(a), 1128(b)(1), 1128(b)(2), or
128(b)(3) of the Act; or has been assessed a civil monetary penalty under sections
128A or 1129 of the Act; or has been excluded from participation in a program under
Title XVIII of the Act (Medicare) or a state health care program. If that first showing is
made, then the business entity is subject to exclusion on the further showing that the
person in question bears a relationship of responsibility, defined in detail at section
128(b)(8)(A), to that business entity.

In this case, the I.G. has made the first showing, as I have discussed above. Petitioner
Bethany Anne Winther-Galimore has been convicted of an offense described in section
128(a)(1) and has been excluded from all federal health care programs.

The I.G. has made the second showing as well. Winther-Galimore acknowledged
ownership of WFCC to the Missouri State Board of Chiropractic Examiners. I.G. Ex. 4,
at 3; P. Ex. 9, at 3. Her ownership of WFCC is affirmed in other official business filings
in the Missouri Secretary of State’s office. I.G. Exs. 11 and 12. She appears as WFCC’s
agent in similar official filings in that office. I.G. Exs. 5 and 6. Both relationships are
among those defined at section 1128(b)(8)(A).

Because the I.G. has established a basis for the exclusion of Petitioner Winther Family
Chiropractic Center, LLC, pursuant to section 1128(a)(8) of the Act, its exclusion for five
years is authorized by 42 C.F.R. § 1001.1001(b)(1). That period is reasonable as a matter
of law.

VI. Conclusion

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

For the reasons set forth above, the I.G.’s Motion for Summary Disposition should be,
and it is, GRANTED. The I.G.’s exclusion of Petitioners Bethany Anne Winther-
Galimore and Winther Family Chiropractic Center, LLC, from participation in Medicare,
Medicaid, and all other federal health care programs for a period of five years pursuant to
10

the terms of sections 1128(a)(1) and 1128(b)(8) of the Act, 42 U.S.C. §§ 1320a-7(a)(1)
and 1320a-7(b)(8), is sustained.

/s/

Richard J. Smith
Administrative Law Judge