Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
Hawthorne Inn of Danville, Date: June 11, 2008
)
Petitioner, )
)
-Vv.- ) Docket Nos. C-07-746

) C-08-10

Centers for Medicare & Medicaid ) Decision No. CR1801
Services. )
)

DECISION

In this case, I consider a long term care facility’s responsibilities when it receives
inconsistent, ambiguous, or otherwise irregular medication orders.

Petitioner, Hawthorne Inn of Danville (Petitioner or facility), is a long term care facility
located in Danville, Illinois, that is certified to participate in the Medicare program as a
provider of services. Petitioner challenges the Centers for Medicare & Medicaid
Services’ (CMS’s) determination that, based on a July 19, 2007 survey, it was not in
substantial compliance with program participation requirements. CMS asks for summary
affirmance of its determination.

I grant CMS’s motion. Based on the undisputed evidence, I conclude that the facility was
not in substantial compliance with requirements governing medication errors (42 C.F.R.

§ 483.25(m)(2)) and pharmacy services (42 C.F.R. § 483.60), and I affirm the imposition
of two $5,000 per instance civil money penalties (CMPs).

I. Background
The Social Security Act (Act) sets forth requirements for nursing facility participation in

the Medicare program, and authorizes the Secretary of Health and Human Services to
promulgate regulations implementing those statutory provisions. Act, § 1819. The
2

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 survey agencies to conduct periodic surveys to
determine whether skilled nursing facilities are in substantial compliance with program
participation requirements. Act, § 1864(a); 42 C.F.R. § 488.20. The regulations require
that each facility be surveyed once every twelve 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.

Here, following a July 19, 2007 complaint investigation survey, CMS determined that the
facility was not in substantial compliance with Medicare participation requirements, and
that its deficiencies posed immediate jeopardy to resident health and safety. Based on
these determinations, CMS imposed against the facility two $5,000 per instance CMPs
($10,000 total).

Petitioner requested a hearing and the case was assigned to me. I issued an initial pre-
hearing order which directed the parties to file pre-hearing exchanges, including briefs
and proposed exhibits, that included the written direct testimony of all proposed
witnesses. The parties complied, filing their initial briefs and exhibits. CMS filed 63
proposed exhibits (CMS Ex 1 — CMS Ex. 63) but later withdrew CMS Exs. 14 - 19 and
51, and Petitioner filed 57 proposed exhibits (P. Ex. 1 — P. Ex. 55, P. Ex. 57, and P. Ex.
58, with P. Ex. 56 intentionally omitted). CMS subsequently moved for summary
judgment, which Petitioner opposes (P. Opp. Br.).

II. Issues

I consider first whether summary judgment is appropriate.

On the merits, the case presents the following questions:

. whether, at the time of the July 19, 2007 survey, the facility was in substantial
compliance with program participation requirements, specifically 42 C.F.R.

§ 483.25(m)(2) (medication errors), and 42 C.F.R. § 483.60 (pharmacy services);

. if the facility was not then in substantial compliance, are the two $5,000 per
instance CMPs reasonable?
III. Discussion

A, Summary judgment is appropriate because Petitioner has not brought
forth evidence sufficient to establish a genuine factual dispute.'

“To defeat an adequately supported summary judgment motion, the non-moving party
may not rely on the denials in its pleadings or briefs, but must furnish evidence of a
dispute concerning a material fact... .” Livingston Care Center, DAB No. 1871, at 5
(2003). The moving party may show the absence of a genuine factual dispute 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 Center v. Dep’t of Health and Human Services, 388
F.3d 168, 173 (6" Cir. 2004). To avoid summary judgment, the non-moving party must
then act affirmatively by tendering evidence of specific facts showing that a dispute
exists. 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 Rehabilitation
Center, DAB No. 1918 (2004).

Here, CMS has come forward with evidence — the facility’s own records — establishing
that:

. a facility resident, identified as R3, was admitted to the facility from an acute care
hospital;
. R3's transfer documents included two different orders for a powerful

chemotherapy drug, one calling for daily administration of the medication, the
other calling for weekly administration;

. facility staff forwarded to the facility’s consulting pharmacist one of those
medication orders, but did not mention the other;

. the consulting pharmacist contacted facility staff, questioning the medication
order;
. staff confirmed the order for daily administration, but again neglected to mention

the order for weekly administration;

' My findings of fact and conclusions of law are set forth, in italics and bold, in
the discussion captions of this decision.
4

. with the pharmacist’s approval, staff continued to administer the daily dose, which
proved to be a significant drug overdose; and

. R3 became acutely ill, was hospitalized, and died.

In CMS’s view, these facts lead to the inescapable conclusion that the facility did not
ensure that each resident was free of any significant medication error (as required by 42
C.F.R. § 483.25(m)(2)), and that a licensed pharmacist review each resident’s drug
regimen and report irregularities to the attending physician and to the director of nursing
(as required by 42 C.F.R. § 483.60).

Petitioner tenders no evidence suggesting a dispute over any of these facts upon which
CMS bases its case. Instead, Petitioner challenges CMS’s legal conclusions, and provides
a list of questions, which it characterizes as “material issues of fact in dispute” (whether
the two orders were “conflicting and uninterpretable;” whether staff misinterpreted the
order; whether staff committed a medication error; whether staff could rely upon the
review of the consultant pharmacist; whether, and to what degree, the facility was
culpable for the incorrect order; whether R3 died as a result of the medication error;
whether R3's symptoms were consistent with his prior condition; what R3's condition was
upon readmission to the hospital). But most of Petitioner’s questions do not describe
factual disputes; they call for legal conclusions. Those that involve facts, or inferences to
be drawn from facts — such as the potentially dispositive question as to the appropriate
standard of care — are not material. For purposes of summary judgment, I resolve them in
Petitioner’s favor, and Petitioner still does not prevail.

Because the undisputed facts establish deficiencies that are sufficient to sustain the
penalties imposed, CMS is entitled to summary judgment.

B. The facility was not in substantial compliance with 42 C.F.R. § 483.25(m)(2)
nor with 42 C.F.R. § 483.60.

Under the statute 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. To this end, the regulation specifically requires that the
facility “ensure” that its residents are free of any significant medication errors. 42 C.F.R.
§ 483.25(m)(2).
5

The facility also must employ or obtain the services of a licensed pharmacist who, among
other responsibilities, consults “on all aspects of the provision of pharmacy services in the
facility.” 42 C.F.R. § 483.60(b)(1). A licensed pharmacist must review the drug regimen
of each resident at least monthly, and “must report any irregularities to the attending
physician and the director of nursing, and these reports must be acted upon.” 42 C.F.R.

§ 483.60(c)(1) and (2) (emphasis added).

In this case, R3 was an 86-year-old man suffering from a multitude of impairments,
including Alzheimer’s disease, anxiety, rheumatoid arthritis, urinary tract infection,
dehydration, and muscle weakness. P. Exs. 6, 42. He was admitted to the facility on June
3, 2007, transferring from an acute-care hospital. P. Ex. 3. At the time of his admission,
the hospital sent his medication orders to the facility. These orders cover three pages.
One page is labeled “Patient Home Medications” and two are labeled “Current Active
Medications.” P. Ex. 7. Among the many medications listed is methotrexate, a
chemotherapy drug that may also be used to treat rheumatoid arthritis. P. Ex. 38. The
page labeled “Patient Home Medications” calls for a dose of 2.5 mg, by mouth, 3 times
daily (hereafter, I will refer to this order as “daily dose order”). P. Ex. 7, at 1. One of the
pages labeled “Current Active Medications” also calls for 2.5 mg doses of methotrexate
by mouth, but, under the frequency section, the order reads: “Fr@09”, followed by the
following comments:

Comments: **MAY BE GIVEN ON A WEEKLY BASIS
AT HIGHER DOSES - VERIFY DOSING FREQUENCY.**

(Emphasis in original) (hereafter, I will refer to this order as “weekly dose order”). R3's
attending physician signed each page and his signature is dated June 6. P. Ex. 7, at 2.

An error in transcription obviously caused the two different orders. The hospital’s
Medication Administration Record indicates that hospital staff had been administering the
drug weekly. P. Ex. 2. And, in the hospital’s discharge summary, R3's attending
physician left no doubt that he had ordered a weekly dose:

methotrexate 2.5 mg. q. 12 hours X 3 doses, all done on
Fridays. In other words, he takes 3 doses per week, a total of
7.5 mg./week taken on Friday in 3 divided doses.

P. Ex. 9, at 2. Nevertheless, a Medication Reconciliation Sheet lists the daily dose order.
P. Exs. 4, 5. It seems that the attending physician discovered the error, and attempted to
correct it. On a medication list he signed on June 4, 2007, the “3 times daily order” is
scratched out, and “weekly” is written in with an emphatic note: “this is incorrect!
6

Should be q week, not q day.” P. Ex. 8. Unfortunately, the correction was not reflected
in the transfer orders.”

Facility staff opted to administer the drug three times daily. Licensed Practical Nurse
(LPN) Leslie Brown made that decision. She points out that the three times daily order
“was clear:” she had no difficulty interpreting or understanding it. P. Ex. 49, at 3 (Brown
Decl. § 7). On the other hand, in her view, the weekly dose order was “not a standard
accepted notation” so she thought that it was not a complete, correct order. P. Ex. 49, at 3
(Brown Decl. { 10). After confirming that methotrexate may be prescribed for one of
R3's conditions (rheumatoid arthritis), she transcribed the order into the facility’s
computer system, and forwarded the list of prescribed medications — absent the weekly
dose order — to the facility’s consulting pharmacist. P. Ex. 49, at 4 (Brown Decl. § 12).

Soon thereafter, the facility’s consulting pharmacist called the facility and questioned
another nurse, LPN Betty Creasy, about the methotrexate order. LPN Creasy read to him
the daily dose order, and told him that it had been signed by the physician. P. Ex. 50, at
1-2 (Creasy Decl. {] 2,3). The pharmacist told her that the medication could be given
once a week in a higher dose, but after LPN Creasy confirmed the daily order, he did not
inquire further. LPN Creasy did not tell him about the weekly dose order. P. Ex. 50, at 2
(Creasy Decl. § 4). Neither the pharmacist nor facility staff reported any irregularity to
R3's attending physician.

Facility staff continued to administer methotrexate according to the daily dose order until
June 23, 2007, when R3 was hospitalized. P. Exs. 10, 11, 12. He died on June 26, 2007.
His death certificate lists as the cause of death Pancytopenia’ due to methotrexate
toxicity. P. Ex. 22.

? Petitioner argues that the hospital and R3's attending physician were at fault for
not providing accurate and understandable orders. Without doubt, there is much blame to
go around in this sad situation, but the culpability of others is wholly irrelevant to the
question of whether the facility met its responsibilities under the regulations. See
Rosewood Care Center of Peoria, DAB No. 1912 (2004).

* Pancytopenia is an abnormal reduction in the number of red and white blood
cells and blood platelets. As discussed below, Petitioner challenges these conclusions as
to the cause of R3's death, and, for summary judgment purposes, I resolve the issue in
Petitioner’s favor.
7

1. Facility staff did not ensure that R3 would be free of
medication errors because they did not clarify ambiguous
medication orders and they did not provide to the consulting
pharmacist a complete account of R3's medication orders.

The facility concedes that R3 was administered an incorrect medication dose, but argues
that it should not be held accountable for the errors because its nursing staff followed a
signed physician order, and relied on the approval of the facility’s consulting pharmacist.
Petitioner defines the standard of care as follows:

A nurse may rely upon an order that she receives when the
order is clear and has been signed off by the physician and
has been reviewed by the consultant pharmacist.

P. Opp. Br. at 5 (emphasis added). For purposes of summary judgment, I accept this
definition. But facility staff did not meet this standard of care. First, the orders sent to
the facility were not clear. The presence of two different orders created ambiguity, and,
as is implicit in Petitioner’s definition of standard of care, a nurse may not rely on
ambiguous orders, but must obtain clarification. See CMS Ex. 58, at 3-4; CMS Ex. 59,
at 4.

Second, the orders were not, in fact, reviewed by the consultant pharmacist because staff
did not provide him with a complete account of the physician’s orders. LPN Brown
selected what she recognized and understood, but disregarded what she did not
understand. Not only does this violate the standard of care, it violates the facility’s own
policies. The facility’s medication administration policy requires that a// physician orders
be given to the pharmacy “exactly as stated by the physician.” P. Ex. 23 (emphasis
added). The nurse was not free to withhold the order simply because she did not
understand it.

The facility had an opportunity to correct this error when the consulting pharmacist called
expressing his concerns about what he considered irregularities in the methotrexate order.
But, again, staff told him about the daily dose order, and did not mention the weekly dose
order. At a minimum, the pharmacist’s inquiry should have alerted them that this drug
might not be prescribed in a way that they recognized.

Petitioner argues that, with respect to medication orders, a nurse should not be held to the
same standard of care as a pharmacist. P. Ex. 53, at 5 (Chizek Decl. 7). Lagree. Nurses
are simply not expected to possess anywhere near a pharmacist’s level of expertise about
medications and medication orders. (If they did, there would be little need for review of
medication orders by a licensed pharmacist). For this very reason, a nurse may not
8

disregard a medication order that she does not recognize or understand. At a minimum,
she must pass the unintelligible order on to the pharmacist, who presumably has the
expertise to determine its validity. The failure of the facility nurses to do so in this case
violated the standard of care and put the facility out of compliance with 42 C.F.R.

§ 483.25(m)(2).

2. Neither the facility staff nor the consulting pharmacist
conferred with R3's attending physician about the irregular
methotrexate orders, in contravention of the regulations,
FDA warnings, and the facility’s own policies.

Because a high number of fatalities have resulted from the mis-administration of oral
methotrexate, the Food and Drug Administration (FDA) characterizes it as “a high alert
medication” and has issued multiple warnings about its dangers. P. Ex. 38, at 1. When
prescribed for conditions such as rheumatoid arthritis (as opposed to cancer treatment),
the dose is generally administered weekly instead of daily. The FDA warns that the
expectation of daily dosing “has led to serious and sometimes fatal mistakes.” P. Ex. 38,
at 1. To reduce the risk of error, the FDA recommends (among other measures) that
prescribers include the clinical indication within the prescription directions. “That way, if
daily dosing is ordered for an autoimmune disease, the pharmacist will be alert to the
possibility of error.” P. Ex. 38, at 1. If such indication is not included, the pharmacist
“should speak directly with the prescriber to determine the reason for use of methotrexate,
and to verify the proper dosing schedule.” P. Ex. 38, at 1; see also P. Ex. 39.

As noted above, the facility’s consulting pharmacist recognized the irregularity of
prescribing a daily dose of methotrexate for rheumatoid arthritis, and he brought that fact
to the attention of the facility’s nursing staff. But neither he nor the facility staff reported
it to the attending physician, as recommended by the FDA, and required by both the
regulation (42 C.F.R. § 483.60(c)(2)) and the facility’s pharmacy consultant agreement.
(“[the pharmacist] will .. . report in writing any irregularity to the facility’s
Administrator, Medical Director, the resident’s physician, and the Director of Nursing
Services.”) P. Ex. 21, at 1.

The facility also suggests that it should not be accountable for the errors of its consulting
pharmacist. However, to comply with the regulations, the facility must ensure that its
residents are free of drug errors and the facility is responsible for the performance of its
pharmacist, without regard to whether he is an employee or a consultant. Here, the
facility’s contract with its consulting pharmacist echoed the requirements of the
regulations. The facility was responsible for ensuring that its consultant met those terms.
42 C.F.R. § 483.20(k)(3)(i) (“the services provided or arranged by the facility must...
9

meet professional standards of quality.”) (emphasis added); see, Emerald Oaks, DAB No.
1800, at 7 n.3 (2001).

C. The $5,000 per instance penalties are reasonable.

CMS has imposed two penalties of $5,000 per instance — one for the facility’s failure to
ensure that its residents were free of medication errors, and one for its failure to comply
with requirements for pharmacy services. Such penalty is toward the mid-range for per
instance situations ($1,000 — $10,000). 42 C.F.R. § 488.438(a)(2).

The parties have provided me little assistance on the issue of the reasonableness of the
penalties. At most, Petitioner has only marginally raised the issue, arguing only that the
facility was not culpable.

In determining whether penalties imposed are reasonable, I consider 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. 42 C.F.R.

§ 488.438(f)(4). 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; 3) the facility’s prior history of noncompliance in general and
specifically with reference to the cited deficiencies.

I have no information about the facility history. Petitioner has not suggested that its
financial condition affects its ability to pay the penalty.

With respect to the other factors, I consider the severity of the deficiencies significant
enough to warrant a substantial penalty. Petitioner challenges the hospital records and
death certificate conclusion that the mis-administration of methotrexate caused R3's
death. Compare P. Exs. 12, 13 with P. Ex. 19; see also, P. Ex. 24. For summary
judgment purposes, I accept Petitioner’s position that the medication overdoses did not
cause R3's death. However, as the FDA warning establishes, methotrexate can be a very
dangerous drug. P. Ex. 38. Unquestionably, administering on a daily basis what should
have been a weekly dose of methotrexate is likely to cause serious injury, harm,
impairment, or death to a resident, which means that the deficiencies posed immediate
jeopardy to R3's health and safety. 42 C.F.R. § 488.301.

Moreover, the facility was culpable. As discussed above, at multiple points facility
nurses and the consulting pharmacist could have prevented serious error, had they
adhered to the standards of care and the facility policies. That they failed to do so at each
10

point makes the facility culpable. I find that this level of culpability, as well as the
severity of the deficiencies, justify the penalties imposed.

IV. Conclusion

For all of the reasons discussed above, I uphold CMS’s determination that Petitioner was
not in substantial compliance with program participation requirements, and I find
reasonable the imposition of two $5,000 per instance CMPs.

/s/
Carolyn Cozad Hughes
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
)
Tamara Brown, ) Date: June 4, 2008

)
Petitioner, )
)

-Vv.- ) Docket No. C-08-139

) Decision No. CR1799
The Inspector General. )
)

DECISION

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

I. Procedural Background

Petitioner pro se Tamara Brown was a Licensed Practical Nurse and Medicaid provider in
the State of Ohio between November 2005 and July 2006. On August 15, 2006,
Petitioner was indicted by the Special Grand Jury sitting for the Court of Common Pleas,
Franklin County, Ohio, and charged with one count of Medicaid Fraud, in violation of
OHIO REV. CODE § 2913.40(B). That offense is classified as a fourth-degree felony
based on the amount of Petitioner’s claims for Medicaid services purportedly provided by
her.

Petitioner appeared with counsel in the Court of Common Pleas, Franklin County, Ohio,
on March 20, 2007, and pleaded guilty to the stipulated lesser included offense of
Attempted Medicaid Fraud, a first-degree misdemeanor offense. She was sentenced on
the same day to a fine of $100.00 and the payment of her prosecution’s costs.
2

Section 1128(a)(1) of the Act mandates the exclusion of “[a]ny individual or entity that
has been convicted of a criminal offense related to the delivery of an item or service
under... any State health care program” for a period of not less than five years. On
September 28, 2007, the I.G. notified Petitioner that she was to be excluded pursuant to
the terms of section 1128(a)(1) of the Act for the mandatory minimum period of five
years.

Acting pro se, Petitioner timely sought review of the I.G.’s action by letter dated July 24,
2007. I convened a telephonic prehearing conference on January 28, 2008, pursuant to 42
C.F.R. § 1005.6, in order to discuss the issues presented by the case and procedures for
addressing those issues. The parties agreed that the case likely could be decided on
written submissions, and by Order of February 5, 2008, I established a schedule for the
submission of documents and briefs. All briefing is now complete, and the record in this
case closed on May 19, 2008. All proffered exhibits are admitted to the evidentiary
record on which I decide this case. Throughout these proceedings, Petitioner has
continued to act pro se.

II. Issues

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

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

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

Ill. Controlling Statutes and Regulations

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

§ 1001.101(a). This statutory provision makes no distinction between felony convictions
and misdemeanor convictions as predicates for mandatory exclusion.
3

In Ohio, the crime of Medicaid Fraud is defined by a specific statute, OHIO REV. CODE
§ 2913.40(B), which provides:

No person shall knowingly make or cause to be made a false or misleading
statement or representation for use in obtaining reimbursement from the
medical assistance program.

The crime of Medicaid Fraud is classified by degree according to the value of the
property, services, or funds fraudulently obtained. As classified by OHIO REV. CODE
§ 2913(E), Medicaid fraud can range from a first-degree misdemeanor to a third-degree
felony:

Whoever violates this section is guilty of medicaid fraud. Except as
otherwise provided in this division, medicaid fraud is a misdemeanor of the
first degree. If the value of property, services, or funds obtained in violation
of this section is five hundred dollars or more and is less than five thousand
dollars, medicaid fraud is a felony of the fifth degree. If the value of
property, services, or funds obtained in violation of this section is five
thousand dollars or more and is less than one hundred thousand dollars,
medicaid fraud is a felony of the fourth degree. If the value of the property,
services, or funds obtained in violation of this section is one hundred
thousand dollars or more, medicaid fraud is a felony of the third degree.

Attempts to commit criminal offenses are forbidden by OHIO REV. CODE § 2923.02(a),
which declares that:

(a)No person, purposely or knowingly, and when purpose or knowledge is
sufficient culpability for the commission of an offense, shall engage in
conduct that, if successful, would constitute or result in the offense.

The Act defines “conviction” as including those circumstances “when a judgment of
conviction has been entered against the individual... bya... State... court, regardless
of... whether the judgment of conviction or other record relating to criminal conduct has
been expunged,” section 1128(i)(1) of the Act; “when there has been a finding of guilt
against the individual... bya... State... court,” section 1128(i)(2) of the Act; “when a
plea of guilty or nolo contendere 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 ina... 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.

4

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

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

1. On her accepted plea of guilty on March 20, 2007, in the Court of Common Pleas,
Franklin County, Ohio, Petitioner Tamara Brown was found guilty of the first-degree
misdemeanor offense of Attempted Medicaid Fraud, in violation of OHIO REV. CODE
§§ 2913.40(B) and 2923.02(a). Inspector General Exhibit (1.G. Ex.) 2; Petitioner Exhibit
(P. Ex.) 1.

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

3. A nexus and a common-sense connection exist between the criminal offense to which

Petitioner pleaded guilty and of which she was found guilty, as noted above in Finding 1,
and the delivery of an item or service under a State health care program. I.G. Exs. 2, 3; P.
Ex. 1; Berton Siegel, D.O., DAB No. 1467 (1994).

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

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

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

V. Discussion
The essential elements necessary to support an exclusion based on section 1128(a)(1) of

the Act are: (1) the individual to be excluded must have been convicted of a criminal
offense; and (2) the criminal offense must have been related to the delivery of an item or
5

service under Title XVIII of the Act (Medicare) or any state health care program. Thelma
Walley, DAB No. 1367; Boris Lipovsky, M.D., DAB No. 1363 (1992); Mark D. Perrault,
M.D., DAB CR1471 (2006); Andrew L. Branch, DAB CR1359 (2005); Lyle Kai, R.Ph.,
DAB CR1262 (2004), rev'd on other grounds, DAB No. 1979 (2005). Those two
essential elements are fully established in the record before me.

Petitioner does not deny that she has been convicted, and the fact of her misdemeanor
conviction is clear: I.G. Ex. 1 shows that on March 20, 2007 Petitioner appeared with
counsel in the Court of Common Pleas and pleaded guilty to the crime of Attempted
Medicaid Fraud, a first-degree misdemeanor. The trial court’s acceptance of that guilty
plea and its finding of Petitioner’s guilt are explicit in the Entry reflecting the
proceedings, and are underscored by the fact that the trial court proceeded immediately to
the imposition of sentence. I.G. Ex. 1. Those procedural steps satisfy the definition of
“conviction” set out at section 1128(a)(1) of the Act. The I.G. has proven the first
essential element.

The submission of false billings to the Medicare and Medicaid programs has been
consistently held to be a program-related crime within the reach of section 1128(a)(1).
Jack W. Greene, DAB No. 1078 (1989), aff'd sub nom. Greene v. Sullivan, 731 F. Supp.
835 (E.D. Tenn. 1990); Mark D. Perrault, M.D., DAB CR1471; Kennard C. Kobrin,
DAB CR1213 (2004); Norman Imperial, DAB CR833 (2001); Egbert Aung Kyang Tan,
M.D., DAB CR798 (2001); Mark Zweig, M.D., DAB CR563 (1999); Alan J. Chernick,
D.D.S., DAB CR434 (1996). It is of no significance whatsoever that Petitioner’s
conviction was for Attempted Medicaid Fraud, as distinct from the completed offense of
Medicaid Fraud. The plain rule is that an attempt to commit a program-related offense is
the “necessary precursor to and part of ” a completed offense and is a sufficient predicate
for exclusion. Kenneth M. Behr, DAB No. 1997 (2005); Yvette Greaves, DAB CR1403
(2006); Sheila Mauney, DAB CR31 (1989).

I find that the Indictment and the Entry of proceedings on March 20, 2007, especially
when read in the context of OHIO REV. CODE §§ 2913(E) and 2923.02(a), demonstrate
the requisite nexus and common-sense connection between the criminal act and the
program. Berton Siegel, D.O., DAB No. 1467. I also believe that Petitioner’s conviction
for attempting to violate OHIO REV. CODE § 2913.40(B), given the statute’s specific
application to the Medicaid program, is a program-related crime as a matter of law. See,
e.g., Stanley Junious Benn, DAB CR1501 (2006); Mark D. Perrault, M.D., DAB CR1471
(2006). The I.G. has proved the second essential element.

Petitioner’s first defense to the exclusion is based on her assertion that at the time of her
plea and conviction she was unaware that the conviction could result in the imposition of
the exclusion sanction. P. Ans. Br. at 1. Whether her assertion is true or not is

6

immaterial, for assuming, arguendo, her ignorance of the mandatory operation of section
1128(a) of the Act when she tendered her plea, her ignorance would neither invalidate the
conviction nor bar the exclusion. Charmaine Sue Moon, DAB CR1769 (2008); Marietje
Kindangen, DAB CR1765 (2008); Timothy Wayne Hensley, DAB CR1415 (2006); Stella
Remedies Lively, DAB CR1369 (2005); Steven Caplan, R.Ph., DAB CR1112 (2003),
aff'd, Steven Caplan v. Tommy G. Thompson, Civ. No. 04-00251 (D. Hawaii, Dec. 17,
2004).

Her second defense asserts that the I.G. was misled into believing that her conviction was
of a felony, and not a misdemeanor. P. Ans. Br. at 1. There is no evidence to support that
suggestion, nor does it appear that the I.G. was under any such misapprehension, but the
plain language of section 1128(a)(1) makes no distinction between convictions based on
misdemeanors and convictions based on felonies. A conviction based on either class of
criminal offense is an adequate predicate for an exclusion based on section 1128(a)(1).
Lorna Fay Gardner, DAB No. 1733 (2000); Tanya A. Chuoke, DAB No. 1721 (2000);
Amable de los Reyes Aguiluz, DAB CR1417 (2006).

A dispute over her payment of costs and the fine included in her sentence is the basis of
Petitioner’s third defense. P. Ans. Br. at 2. Her argument is unclear, but it does not alter
the fact of her conviction. Even assuming that the amount of costs and fine were related
to the amount of loss to Ohio’s Medicaid program, that amount would not be relevant to
these proceedings, since the I.G. has not attempted to enhance Petitioner’s period of
exclusion by invoking the aggravating factors set out at 42 C.F.R. §§ 1001.102(b)(1) and
02(b)(7)."

Petitioner argues an additional point related to her conviction of a misdemeanor offense:
she asserts that the “discretionary exclusion” provisions of section 1128(b)(1)(a) of the
Act, 42 U.S.C. § 1320a-7(b)(1)(a), should control her situation. By that argument
Petitioner seeks to avoid the mandatory effect of section 1128(a)(1). See Petitioner’s
notes on P. Ex. 8. But once a conviction is shown to be within the reach of section
128(a)(1), the mandatory operation of that section bars any petitioner, including this one,
from demanding that other more lenient, more discretionary, or more favorable
exclusionary provisions should be applied instead. Even in situations where the
underlying conviction could be argued to fall within both section 1128(a)(1) and one or
more of the permissive exclusions or three-year mandatory minimum periods of sections
128(b)(1)-(15), the rule is clear: if section 1128(a)(1) fits, then the mandatory exclusion

‘Nor has the I.G. sought to enhance the period of Petitioner’s exclusion by reliance
on the aggravating factor listed at 42 C.F.R. § 1001.102(b)(9), evidence concerning which
aggravating factor was submitted by Petitioner herself, in P. Exs. 9, 10, 11.
7

and mandatory minimum period prescribed by section 1128(a)(1) must be imposed. The
LG. may not choose to proceed under an alternative statute. Stacy Ann Battle, D.D.S.,
DAB No. 1843 (2002); Tarvinder Singh, D.D.S., DAB No. 1752 (2000); Lorna Fay
Gardner, DAB No. 1733; Douglas Schram, R.Ph., DAB No. 1372 (1992); Niranjana B.
Parikh, M.D., DAB No. 1334 (1992); David S. Muransky, D.C., DAB No. 1227 (1991);
Leon Brown, M.D., DAB No. 1208 (1990); Napoleon S. Maminta, M.D., DAB No. 1135
(1990); Charles W. Wheeler, DAB No. 1123 (1990); Jack W. Greene, DAB No. 1078,
aff'd sub nom. Greene v. Sullivan, 731 F. Supp. 835.

Petitioner challenges the proposed period of exclusion as “harsh, cruel, and unusual
punishment.” P. Ans. Br. at 3. The five-year period of exclusion proposed in this case is
the statutory minimum required by section 1128(c)(3)(B) of the Act. As a matter of law it
is not unreasonable. 42 C.F.R. § 1001.2007(a)(2). Mark K. Mileski, DAB No. 1945
(2004); Salvacion Lee, M.D., DAB No. 1850 (2002); Krishnaswami Sriram, M.D., DAB
CR1463 (2006), aff'd, DAB No. 2038 (2006).

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 (2007);
Thelma Walley, DAB No. 1367 (1992). Summary disposition is authorized by the terms
of 42 C.F.R. § 1005.4(b)(12). This forum looks to FED. R. CIV. P. 56 for guidance in
applying that regulation. Robert C. Greenwood, DAB No. 1423 (1993). The material
facts in this case are undisputed and unambiguous. They support summary disposition as
a matter of settled law. This Decision issues accordingly.

VI. Conclusion

For the reasons set out above, the I.G.’s Motion for Summary Affirmance should be, and
is, GRANTED. The I.G.’s exclusion of Petitioner Tamara Brown from participation in
Medicare, Medicaid, and all other federal health care programs for a period of five years,
pursuant to the terms of section 1128(a)(1) of the Act, 42 U.S.C. § 1320a-7(a)(1), is
thereby affirmed.

/s/
Richard J. Smith
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
)
Laurelwood Care Center, ) Date: May 30, 2008

(CCN: 39-5812), )
)
Petitioner, )
)

-Vv.- ) Docket No. C-07-222

) Decision No. CR1796
Centers for Medicare & Medicaid )
Services. )
)

DECISION

Petitioner, Laurelwood Care Center, is a long-term care facility located in Johnstown,
Pennsylvania, that is certified to participate in the Medicare program as a provider of
services. After receiving a report that a resident was found dead, with his face and arm
caught in his bed’s side rail, surveyors from the Pennsylvania Department of Health,
Division of Nursing Care Facilities (State Agency) surveyed the facility. As a result of
their findings, the Centers for Medicare & Medicaid Services (CMS) determined that: 1)
from August 22 through November 27, 2006, the facility was not in substantial
compliance with the program requirement that the resident environment remain as free of
accident hazards as possible (42 C.F.R. § 483.25(h)(1)); and 2) from August 22 through
25, 2006, its deficiencies posed immediate jeopardy to resident health and safety. CMS
imposed civil money penalties (CMPs) of $5000 per day for four days of immediate
jeopardy, and $100 per day for 94 days of substantial noncompliance that was not
immediate jeopardy ($29,400 total). Petitioner here challenges those determinations.

For the reasons set forth below, I find that the facility was not in substantial compliance
with program requirements for the period in question, and that, from August 22 through
25, 2006, its deficiencies posed immediate jeopardy to resident health and safety. I find
reasonable the CMP amounts.
I. Background

The Social Security Act (Act) sets forth requirements for nursing facility participation in
the Medicare program, and authorizes the Secretary of Health and Human Services 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 survey agencies to conduct periodic surveys to
determine whether skilled nursing facilities are in substantial compliance with program
participation requirements. Act § 1864(a); 42 C.F.R. § 488.20. The regulations require
that each facility be surveyed once every twelve 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.

In this case, on August 21, 2006, the facility reported that a 64-year-old facility resident
(R1) had been found dead, caught in one of the side rails attached to his bed. CMS
Exhibit (Ex). 10; Tr. 121. Surveyors went to the facility to investigate. They determined
that the facility had not ensured that R1’s environment was as free of accident hazards as
possible. Although the facility placed R1 in a bed with side rails that were 8 inches apart
—a gap much wider than the Food and Drug Administration (FDA) recommended
maximum of 4% inches — no documentation showed that staff had adequately assessed
the potential safety hazards posed by putting him in a bed with such side rails. CMS Ex.
2, at 4 et seq.; CMS Ex. 58, at 15, 18. The surveyors also determined that the facility had
inadequately assessed for safety the use of similar side rails on the beds of 53 other
residents reviewed, and that this failure posed immediate jeopardy to resident health and
safety. CMS Ex. 2, at 3. Based on the survey findings, CMS determined that the facility
was not in substantial compliance because it failed to ensure that the resident environment
remained as free of accident hazards as possible — as required by 42 C.F.R.

§ 483.25(h)(1) — at scope and severity level K (pattern of immediate jeopardy).

CMS has imposed CMPs of $5000 per day for four days of immediate jeopardy, and
$100 per day for 94 days of substantial noncompliance that was not immediate jeopardy.
CMS Ex. 9.

The facility timely requested a hearing, and the matter was assigned to me. I held a
hearing in Pittsburgh, Pennsylvania on November 6 through 7, 2007. Mr. Christopher S.
Lucas appeared on behalf of Petitioner, and Mr. Alan C. Horowitz appeared on behalf of
CMS.
I admitted CMS Exs. 1-71 and Petitioner (P.) Exs. 1-8 and 10-31. Transcript (Tr.) 2-3;
Ruling on Petitioner’s Motion to Exclude CMS’s Proposed Exhibits, and Petitioner’s
Request for Issuance of Subpoenas (October 19, 2007). I declined to admit P. Ex. 9,
autopsy photographs of the deceased resident. While I recognize the occasional need to
introduce intrusive or even seemingly disrespectful evidence, I find the probative value of
these photographs insufficient to justify their admission. Petitioner argued that the
pictures would help establish that R1 was not wedged between the rails, but was instead
caught between his mattress and side rail. As discussed below, establishing that R1 died
wedged between mattress and side rail would not further Petitioner’s case. Moreover,
Petitioner had the opportunity to make its point through the testimony of its witnesses,
including the attending pathologist, who could simply describe their observations,
including whatever marks they observed on R1’s neck. Tr. 3-4.'

The parties have filed initial briefs (Br.) and closing briefs (Cl. Br.).

II. Issues

This case presents the following questions:

1. Whether, from August 22 through November 27, 2006, the facility was not in
substantial compliance with requirements for facilities participating in the
Medicare program, specifically 42 C.F.R. § 483.25(h)(1), because it failed to

ensure that the resident environment was as free of accident hazards as possible.

2. If the facility was not in substantial compliance from August 22 through 25, 2006,
did its deficiencies then pose immediate jeopardy to resident health and safety?

3. If the facility was not in substantial compliance, were the CMPs — $5000 per day
for the period of immediate jeopardy and $100 per day for the period of substantial
noncompliance that was not immediate jeopardy — reasonable?

' Petitioner incorrectly suggests that it was not allowed to present expert testimony
regarding whether the resident was injured by the gaps in his bed rails. P. Cl. Br. at 23.
Although the pictures were not admitted, the witnesses had every opportunity to address
the cause of R1’s death. See P. Ex. 3 (Lees Decl.); P. Ex. 4 (Ashcraft Decl.); Tr. 299 et
seq., 304 et seq.
III. Discussion

A, The facility was not in substantial compliance with 42 C.F.R. § 483.25(h)(1)
(quality of care) because it routinely used side rails without adequately assessing
the potential safety hazards they posed to the individual residents, and because it
failed to make sure that the side rails in use were as safe as possible.”

Under the statute 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. Among other requirements, the facility must ensure that
the resident environment is as free of accident hazards as possible. 42 C.F.R.

§ 483.25(h)(1).

1. Facility policies did not reflect the standard of care,
which mandates that: a) side rails be used only where an
individualized resident assessment establishes that their
potential benefit outweighs safety risks; and b) the facility
takes steps to minimize the risk of entrapment whenever side
rails are used.

No one disputes that side rails can represent an accident hazard. At one time they were
used more-or-less routinely in hospitals and nursing homes, but health care professionals
and others now recognize the risks their use presents, particularly to the elderly and
infirm.

[S]ide rails present an inherent safety risk, particularly when
the patient is elderly or disoriented. Even when a side rail is
not intentionally used as a restraint, patients may become
trapped between the mattress or bed frame and the side rail.

CMS Ex. 60, at 5 (quoting U.S. Department of Health and Human Services, Health Care
Financing Administration, State Operations Manual Provider Certification Transmittal
17, A-182-183 (June 2000) (guidance to surveyors in the implementation of 42 C.F.R.
Part 482 Medicare and Medicaid Programs)).

? My findings of fact and conclusions of law are set forth, in italics and bold, in
the discussion captions.
5

The FDA has issued alerts and other warnings describing the dangers posed by side rail
use. In an alert dated August 23, 1995, for example, the FDA warned that individuals
with pre-existing conditions such as confusion, restlessness, lack of muscle control, or a
combination of these factors, were at “high risk for entrapment.” CMS Ex. 57, at 2.
“Entrapment” is defined as an event in which the individual is “caught, trapped, or
entangled in the space in or about the side rail, mattress, or hospital bed frame.” CMS
Ex. 58, at 6.

The standard of care mandates that side rails be used only where an individualized
resident assessment establishes that their potential benefit outweighs the risks. An
interdisciplinary team performs the assessment and makes the determination. Tr. 22, 56.
The assessment should include consideration of the resident’s diagnoses, behavioral
symptoms, sleep habits, medications, cognition, communication, mobility (in and out of
bed), risk of falling, and any other relevant concerns. It should include consideration of
the sleeping environment and the resident’s care plans. Hospital Bed Safety Workgroup,
Clinical Guidance for the Assessment and Implementation of Bed Rails in Hospitals,
Long Term Care Facilities, and Home Care Settings (April 2003); CMS Ex. 60, at 6-14;
CMS Ex. 66, at 4-5 (Osterweil Decl. § 13); Tr. 107, 114, 188, 214, 269.

Beryl D. Goldman, Ph.D, RN, NHA is the outreach leader for the FDA’s Hospital Bed
Safety Workgroup. CMS Ex. 65, at | (Goldman Decl. ¥ 1); Tr. 102. She is also the
director of the Pennsylvania Restraint Reduction Initiative, and has written and lectured
widely on issues involving the elderly and long term care. Dr. Goldman opined that side
rails should be the exception, not the norm. Facilities should begin with the presumption
that side rails not be used, and should place the burden on the side rail proponent to
demonstrate that their use is appropriate. Tr. 107, 114; see also CMS Ex. 43, at 8 (“The
automatic use of bed rails may pose unwarranted hazards to patient safety.”) and 10
(“Avoid the automatic use of bed rails of any size or shape.”). The facility’s medical
director, Balkissoon Maharajh, M.D., acknowledged that the American Medical Directors
Association “prefer[s] that side rails be used at a minimum, if at all they have to be used.”
Tr. 214.

Dan Osterweil, M.D., C.M.D. (Certified Medical Director) is a physician who specializes
in geriatrics and long term care, and is obviously well-qualified to discuss standards of
care for nursing homes.? CMS Ex. 66, at 1-2 (Osterweil Decl. 4 1), 9-31 (Osterweil

* Among other accomplishments, Dr. Osterweil is a clinical professor of medicine
at the University of California in Los Angeles, editor-in-chief of the Journal of the

American Medical Directors Association, research associate in gerontology services at
(continued...)
6

Curriculum Vitae). Dr. Osterweil agreed that the standard of care requires that nursing
personnel perform an individualized risk assessment before side rails are ordered or used.
CMS Ex. 66, at 4-5 (Osterweil Decl. § 13); Tr. 53-54.

Petitioner’s own witnesses, including its Director of Nursing (DON), Terri Russo, agreed
that the facility must assess whether the side rail benefits outweigh the risks to resident
safety. P. Ex. 11, at 3 (Russo Decl. § 23); Tr. 188; see also P. Ex. 13, at 2 (Polantz Decl.
q 12); Tr. 269.

Dr. Goldman also testified that if rails are not to be used, they should be removed entirely
from the bed to prevent their unauthorized use, which seems a sensible precaution that is
easily implemented. Tr. 99.4

Although Petitioner claims that its staff were well aware of the FDA’s concerns, it does
not seem that they took those warnings very seriously. Indeed, notwithstanding its
denials, the evidence suggests a strong facility bias in favor of side rails. DON Russo
acknowledges that the risks posed by side rails include entrapment, injury, and death, but
she characterizes those risks as “remote,” and suggests that failing to provide side rails
creates even greater risks, which, in her view, include immobility, bed sores, helplessness,
and depression. P. Ex. 11, at 1, 3 (Russo Decl. § 8, 9, 29).° According to DON Russo,

4(...continued)
UCLA/Jewish Home for the Aging Borun Center for Gerontological Research, and
medical director for the Gerontology Services at Sherman Oaks Hospital & Health
System. He has also written and lectured widely on issues involving geriatrics and
nursing home care. CMS Ex. 66, at 9-31.

+ Every bed in the facility was equipped with side rails, which created a risk of
unauthorized use. CMS Ex. 68, at 15 (LaMantia Decl. § 45). Petitioner attempts to
minimize the significance of this fact with a declaration from the facility’s medical
records director, which claims that “not all of the [facility] residents. . . on August 20,
2006 had bed rails in use.” P. Ex. 12 (Rietscha Decl. J 3). But the medical records
director later conceded that he did not know how many side rails were in use. “I wouldn’t
know. I'd have to actually look at the bed and that is not part of my job.” Tr. 236. When
afforded the opportunity to refute the surveyor assertion that every bed in the facility was
equipped with side rails, DON Russo either could not or would not answer the question.
Tr. 175 (“I can’t speak to that.”)

* In contrast, Dr. Goldman pointed out that padded side rails (which all agree are
necessary to fill in gaps wide enough to entrap a head or body) might alleviate some risks,
(continued...)
7

without side rails, residents will not “feel enabled” and “will die.” P. Ex. 11, at 2 (Russo
Decl. §§ 12, 13). “[S]taff simply cannot provide the support that a good side rail can
provide.” P. Ex. 11, at 2 (Russo Decl. § 17). Jolene Polantz, RN, corporate quality nurse
for Petitioner’s parent organization, also claims that the “much higher prevalence of
pressure ulcers” compared to entrapments “skews the risk-benefit analysis in favor of
interventions that prevent pressure ulcers. .. .” According to Nurse Polantz, “There is an
immediate and tangible benefit to the resident that is not automatically outweighed by the
serious but rare risk of entrapment.” P. Ex. 13, at 2 (Polantz Decl. 4 10); see also P. Ex.
14, at 1 (Klein Decl. § 3).

The facility’s practices reflected its bias in favor of side rails. Instructions to staff posted
at the nurses station stated, “Starting today [June 21, 2006], when a new admission comes
in[,] write the preventative order as... Side Rails up X 2 for transfers/repositioning.”
The instruction is signed by Terri Kibler, Wound Care. CMS Ex. 36. The facility
concedes that the two-month-old notice was there, but denies that it reflected facility
policy. P. Ex. 11, at 1 (Russo Decl. § 5); Tr. 174-179, 191. Petitioner’s denials are not
credible. First, no one has explained anything about the origins of the notice, or its
purpose if not to direct staff to justify the wide-spread use of side rails for new
admissions. Nor has Petitioner explained why the notice remained posted for two
months, if not reflective of facility policy. Second, and more significant, the facility
operated as if that were its policy. Side rails were affixed to every bed. CMS Ex. 68, at
15 (LaMantia Decl. 45); Tr. 179. The 53 residents in the surveyors’ sample, as well as
RI, all had orders for side rails. Tr. 183. And, as discussed below, staff cited
“repositioning” to justify an order for rails, even where, as with R1, the resident was
wholly incapable of using side rails for that purpose.

In what it characterizes as R1’s individualized assessment, for example, staff checked
“yes” in response to question 7 of the Side Rail Screen: “Is the resident currently using
the side rail for positioning or support?” P. Ex. 20, at 10. Yet, Rl was obviously not
using side rails for these purposes — he was incapable of voluntary movement and was not
able to use his side rails. P. Ex. 21, at 93; CMS Ex. 15, at 6; CMS Ex. 68, at 14
(LaMantia Decl. § 40); P. Cl. Br. at 5. Moreover, for the vast majority of the
“assessments” that mention side rails, staff have checked “yes” to question 7. For those
with an accompanying assessment team narrative, staff have written some variation of:
“Bilateral elevated side rails for positioning.” P. Ex. 20, at 10, 13, 14, 15, 16, 20, 22, 24,

5(...continued)
but could also make the resident lying in the bed surrounded by pads feel like he/she is
lying in a coffin “so from a psychological perspective[,] I would really be opposed to
using them.” Tr. 89.
8

25, 26, 27, 28, 30, 31, 32, 34, 36, 38, 39, 40, 41, 42, 44, 46, 47, 48, 49, 50, 51, 52, 53, 54,
55, 56, 57, 58, 60, 62, 63, 64, 65, 66, 67, 68, 70, 71, 72, 74, 75, 76, 77, 78, 79, 80, 81, 82
83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 94, 96, 98, 99, 100, 101, 102, 103, 104, 105, 106,
108, 110, 111, 112, 113, 114, 115, 118, 119, 120, 121, 122, 124, 126, 128, 130, 131,132,
134, 135, 136, 138, 140, 141, 142, 143, 144, 146, 148, 149, 150, 151, 152, 154, 156, 158
162, 164, 166, 168, 169, 170, 172; see also CMS Ex. 41. In virtually all of these
documents, the only justification for side rails listed by the assessment team is
“positioning.” This fact, together with the posted instructions (CMS Ex. 36) show that
use of rails was, at the least, the facility’s de facto policy. Moreover, as the following
discussion explains, the facility policy favoring side rail use seems invariably to have
trumped safety considerations.

2. The facility’s use of side rails without adequate
assessments jeopardized resident health and safety.

As discussed above, the parties recognize that individualized assessments are critical for
determining whether the benefits derived from side rail use justify their risks. However,
they dispute whether the facility adequately assessed its residents for side rails.
According to CMS, the facility did not first determine whether any potential benefit
outweighed the safety risks. All 53 residents in the surveyors’ sample (as well as R1)
were in beds with rails and had orders for rails. Yet none had been adequately assessed
for safety. Tr. 183-184.

When surveyors asked the facility administrator, James E. Neely, for safety assessments,
he told them that the facility considered only whether side rails were “enablers” or
restraints. CMS Ex. 68, at 23 (LaMantia Decl. § 72). Administrator Neely has not denied
that he gave the surveyors that information. See P. Ex. 10 (Neely Decl.). In fact, during
his testimony, he reiterated that staff's concern was to demonstrate that they did not
employ rails as restraints:

[U]p until this incident [R1’s entrapment] there was no
question that ever came to our committee or to my attention
that gee, we should be doing something about these rails
because we were looking at them as enablers... . It was my
understanding that the Department of Health was more
concerned about whether they were used as enablers or
restraints.

Tr. 204.
9

Similarly, DON Russo and Corporate Quality Nurse Polantz told the surveyors that they
had no assessments of side rail safety risks. CMS Ex. 68, at 33 (LaMantia Decl. § 101).
Neither has denied making that statement. See P. Ex. 11 (Russo Decl.); P. Ex. 13
(Polantz Decl.). LPN James Winters told the surveyors that all of the residents’ beds had
side rails, and that they were used routinely. CMS Ex. 68, at 10 (LaMantia Decl. § 31).

Notwithstanding the statements DON Russo and her colleagues made to the surveyors,
Petitioner now argues that its “Initial Restraint Assessment” form demonstrates that it
performed the necessary individualized safety assessments, and justifies its use of side
rails. P. Ex. 20, at 10-173; P. Ex. 11, at 4 (Russo Decl. fff 31, 32). But review of those
documents confirms that, at most, the facility considered only whether the rails were
restraints, and did not consider safety.°

The “Initial Restraint Assessment” form is a two page document. P. Ex. 20, at 10, 11.
Page | includes a section titled “Side Rail Screen,” consisting of eight yes-or-no
questions. Page 2 includes a section for the assessment team to fill in, indicating who
comprised the team, and with a space in which to write its notes. See, e.g., P. Ex. 20, at
0, 11; Tr. 255.

The expert witnesses agreed that the form is insufficient as a tool for assessing the
costs/benefits of side rail use. CMS Ex. 65, at 2, 6-7 (Goldman Decl. ff 3, 10, 12, 13);
CMS Ex. 66, at 3-5 (Osterweil Decl. f§ 8, 11, 13, 14, 15). It provides some information,
ut does not suggest how a side rail is more of a benefit than a risk for any particular
individual. Tr. 119-120. Dr. Goldman also explained that an adequate individualized
assessment requires consideration of the environment, i.e., the bed system,” as well as the
individual. None of these forms say anything about the environment. Tr. 104; see CMS
Ex. 60, at 9-14. Petitioner’s own expert, Engineer Mark Bruley, who was also a member
of the FDA’s Hospital Bed Safety Group, agreed that the document addresses restraint
use, but is not adequate for assessing the safety of a bed system. Tr. 271-272.

® The facility used the same rationale (“positioning”) to justify its use of side rails
for each of the residents reviewed, apparently without regard to individual characteristics,
a practice that raises questions about the facility’s use of restraints. However, CMS has
cited no deficiency under the restraint regulation, 42 C.F.R. § 483.13(a), so I do not
consider that issue.

7 The “bed system” is comprised of the bed, mattress, bed rails, and any pads or
accessories in or on the bed. P. Ex. 5, at 1 (Bruley Decl. ¥ 4).
10

Although Petitioner suggests that other facility documents, such as Occupational Therapy
(OT) Assessments, might contain evidence of side rail safety assessments, it has not
produced such documents. Petitioner’s consulting occupational therapist, Angela Klein,
who talked about the potential benefits of side rails (repositioning, assisting with self-
care, increasing independence, aid in transfer), admitted under cross-examination that the
OT evaluations did not address safety risks associated with side rails. P. Ex. 14, at 1
(Klein Decl. § 3); Tr. 73.6

The inadequacies of the facility’s reliance on the “Initial Restraint Assessment” form for
assessing resident safety are well illustrated by the situation of Rl. R1 was the type of
individual that the FDA Alerts placed at high risk for entrapment. He was a 64-year-old
mentally retarded man with a seizure disorder who required complete care. He was a
very small man, just 4'10" and 120 pounds, and he was incapable of voluntary movement.
CMS Ex. 15, at 11; CMS Ex. 12, at 2. The facility kept him in a bed with the side rails
up. Tr. 37-38, 41. According to his Initial Restraint Assessment, R1 is “currently using
the side rail for positioning and support.” P. Ex. 20, at 10. This, of course, is patently
incorrect; R1 was not capable of any voluntary movement. On the second page of that
purported assessment is a space for indicating who comprised the assessment team and
for writing in any notes. P. Ex. 20, at 11; Tr. 255. But, for R1, that entire page is blank,
which, as Corporate Quality Nurse Polantz conceded, indicates that the assessment team
did not meet. Tr. 256; P. Ex. 20, at 11.

CMS’s experts also agreed that side rails are not the best means for protecting an
individual with a seizure disorder or who cannot move voluntarily, an opinion that
Petitioner’s experts have not challenged. Tr. 41, 87-88. Even Engineer Bruley testified
that “forces involved in a seizure could be more than sufficient to separate the hook and
loop closures used to attach the foam filled bed rail pad....” P. Ex. 5, at 2 (Bruley Decl.
4 14). And, as discussed below, the experts agreed that such padding is essential to
protect the resident from becoming entrapped in the 8 inch gap between side rails. Tr. 59,
101, 102, 218, 280. Yet, no one in the facility seems to have considered this very real
safety issue before putting R1 into a bed with such rails. Instead, R1’s Initial Restraint
Assessment simply lists “seizure disorder” as a medical symptom “requiring restraint
use.” Under the summary section of the form, the assessment team is supposed to
indicate “how the use of the restraint promotes or maintains the resident’s highest
practicable physical, mental, and psychosocial well-being.” Again without explanation,
someone has written in “seizure disorder.” P. Ex. 20, at 10. Nothing suggests that

* Therapist Klein also admitted that she educated therapists who worked in the
facility, but had no personal knowledge of its residents. Tr. 71.
11

anyone considered the dangers that side rails, particularly widely-spaced side rails, could
pose to an individual with a seizure disorder.’

Medical Director Maharajh, who was R1’s physician, initially testified that the placement
of padded side rails on R1’s bed was “within the standard of care,” but he also admitted
that he did not participate in any risk/benefit analysis with respect to the use of side rails
for R1. Tr. 224. He could not recall any conversations with staff regarding R1’s need for
side rails. Tr. 229. He had never before seen R1’s initial restraint assessment. Tr. 231.
He had not signed off on it, and had not even seen “this type of document” before. Tr.
232, 233. Dr. Maharajh also agreed that another approach — placing R1 in a low bed with
adjacent mats — would have been “reasonable.” Tr. 225.

Engineer Bruley could not recall seeing any evidence that the facility had conducted an
appropriate risk/benefit analysis of side rail hazards for Rl. Tr. 269-270.

3. The facility did not ensure that its bed systems were as
safe as possible.

If side rails are required, close attention must be given to their design and the relationship
between the rails and the other parts of the bed. Among other considerations, “[t]he bars
within the bed rails should be closely spaced to prevent a patient’s head from passing
through the openings and becoming entrapped.” CMS Ex. 60, at 14. The FDA
recommends inspection of all hospital bed frames, side rails, and mattresses as part of a
regular maintenance program to identify areas of possible entrapment, as well as the use
of protective barriers to close off open spaces in which patients might accidently become
entrapped, CMS Ex. 57, at 2,3. Alignment of the bed frames, side rail, and mattress
“should leave no gap wide enough to entrap a patient’s head or body.” CMS Ex. 57, at 2.
To this end, the FDA recommends that rails be no more than 4% inches apart. CMS Ex.
52.

Petitioner claims that R1’s bed was “totally [excluded]” from the FDA guidelines because
it was an “air fluidized therapy” bed. P. Cl. Br. at 3-4. In a May 10, 2006 issuance, the
FDA recognized that certain pressure reduction therapeutic products

may pose an additional risk of entrapment when used with
conventional hospital bed systems. When these types of

° The document is also inconsistent. On the one hand, it suggests that side rails
were not restraints, but “enablers” used for “positioning.” On the other hand, it says that
they were restraints, justified by R1’s seizure disorder. P. Ex. 20, at 10.
12

mattresses compress, the space between the mattress and the
bed rail may increase and pose an additional risk of
entrapment. While entrapments have occurred with the use of
framed flotation therapy beds (specialty air beds built into a
hospital bed frame) and air mattress replacements, these
products are excluded from the dimensional limit
recommendations, except for those spaces within the
perimeter of the rail.

CMS Ex. 58, at 12 (U.S. Department of Health and Human Services, Food and Drug
Administration, Hospital Bed System Dimensional and Assessment Guidance to Reduce
Entrapment) (emphasis added). The recommendations explain that the exemption is due
to the highly compressible nature of the mattresses, which present technical difficulties in
measuring. Nevertheless, the FDA re-emphasizes that, before using these products,
facilities take steps “to ensure that the therapeutic benefit outweighs the risk of
entrapment.” Jd. In a published interview, Engineer Bruley re-emphasized that “users [of
these products] should identify and address areas of potential entrapment for each resident
through a comprehensive bed safety program.” CMS Ex. 53, at 6.

Thus, the FDA’s so-called exemption does not even apply to the spaces between the rails
— the maximum 4% inch recommendation still applies to them. With respect to other gaps
in the bed system, the FDA acknowledges how difficult it is to come up with standard
measurements that would render all the systems safer. If anything, this means that the
facility has an even greater responsibility to examine carefully the safety of its bed system
when these products are used. And the manufacturer’s instructions reflect this concern.
They emphasize “Ensure against any gaps that might entrap the patients’ head or body.”
CMS Ex. 48, at 3 (emphasis in original).

In any event, although far from ideal, I am satisfied that widely-spaced bed rails do not
per se violate any standard of care.’ According to Engineer Bruley — and CMS does not

'° The bed systems in question are quite old, and the appearance of the widely-
spaced side rails is startling to anyone accustomed to newer models. See P. Ex. 8, at 7; P.
Ex. 10, at 1 (Neely Decl { 9) (referring to age and frequency of repair); Tr. 203-204; Tr.
61 (Dr. Osterweil: “And it kind of reminds me of maybe a picture from [Romania] or
from some very different place than I’m used to being or maybe the United States 50
years ago.”) I questioned witnesses and counsel about the appearance of the rails, as well
as the significance of the FDA spacing guidelines. Citing my questions and comments,
Petitioner asked that I recuse myself from this case, a motion I denied in orders dated

(continued...)
13

appear to disagree — such bed systems can be made acceptably safe by eliminating the
excessive gaps. High density foam and foam-filled pads may be used “to mitigate
entrapment hazards posed by the 8" gaps between the vertical bed rails” as well as other
gaps in a bed system. P. Ex. 5, at 1, 2 (Bruley Decl. 4 6, 12).

Engineer Bruley opines that R1’s bed system was “not an accident hazard.” P. Ex. 5, at 2
(Bruley Decl. § 10). In his view, the foam-filled pad used to separate R1 from the bed rail
“was a reasonable accessory to use to mitigate entrapment hazards posed by the 8" gaps
between the vertical bed rails.” P. Ex. 5, at 2 (Bruley Decl. § 12). On the other hand,
viewing what Petitioner represents as a photograph of R1’s bed system (or reasonable
facsimile), both Drs. Goldman and Osterweil pointed out multiple, significant problems.
P. Ex. 8, at 7. According to Dr. Osterweil,

You can easily stick a hand between the pad and the mattress
in each of those [8 inch] gaps. You have exposed edges and
you can actually stick a part of your body between the head of
the bed and the headboard. You have only one support to that
rail at the far end of the bed — the right side of the picture
allows you to lower it or raise it, and that even is not very safe
for caregivers because once they do it they can actually catch
their hand in between the metal frame and the rail. And it
kind of reminds me of maybe a picture from [Romania] or
from some very different place than I’m used to being or
maybe the United States 50 years ago.

Tr. 61.

Dr. Goldman agreed that the side rails in use presented significant risk to resident safety;
the gaps between the rails were too great; the gap between the headboard and the rail
presented a problem. She also noted the psychological damage of putting the side panels
up because it makes the bed feel “like a coffin.” Tr. 89, 101-102.

I find more plausible the observations from CMS’s experts, which are also consistent with
Engineer Bruley’s underlying premise — that excessive gaps in bed systems are accident
hazards unless they are filled in — than Engineer Bruley’s conclusion. Engineer Bruley
does not explain how the bed can be safe in light of the obvious, significant gaps. Nor

'(.continued)
December 13, 2007, and January 15, 2008. In fact, based on responses to my comments,
I resolve questions of a per se violation in Petitioner’s favor.
14

does he explain how a resident with a seizure disorder can safely rely on a rail pad if his
seizure activity “could be more than sufficient” to separate the pad from the rail. P. Ex. 5,
at 2 (Bruley Decl. § 14).

Even if I accepted Engineer Bruley’s conclusion about the safety of R1’s bed system
(which I do not), I would still find that the facility did not ensure that its bed systems
were as safe as possible because so many residents were in beds with widely-spaced rails
that had no padding or other fillers to protect them from entrapment between the rails.

Of the residents sampled, only two had padded side rails. The surveyors observed that
the others had the widely-spaced but unpadded rails.'' Tr. 142-144, 150. All of the
experts, including Petitioner’s witnesses Bruley and Maharajh, agreed that, without the
padding, the side rails are simply unsafe. They pose an accident hazard and are not
within the standard of care. Tr. 218, 280.

The surveyors also found problems with those few beds that had padding. For R2, the
padding was not attached to the side rail, exposing side rail gaps. R2 was in bed, leaning
toward the unpadded section of the rail. CMS Ex. 68, at 16 (LaMantia Decl. § 48).
Similarly, when his body was found wedged between the rails, R1’s rail pad was no
longer attached to the rail but was “hanging down toward the floor.” CMS Ex. 22, at 1.’

4. The facility inadequately responded to evidence of
problems with the side rails.

Administrator Neely justifies the absence of safety assessments by claiming that
“investigation of accidents and analysis of their frequency are key tools in preventing
accidents in the future.” P. Ex. 10, at 1 (Neely Decl. § 6). No one would disagree about
the importance of investigation and analysis of accidents. But the evidence here
establishes that the facility neither adequately investigated accidents in which side rails
were implicated, nor adequately analyzed and responded to the problems they posed.

'' One resident (R11) had bed rails that were 7 % inches apart. All of the others
were 8 inches apart. CMS Ex. 68, at 33 (LaMantia Decl. ¥ 100); Tr. 143.

® Engineer Bruley produced a side rail pad which he identified as the pad attached
to R1’s bed. P. Ex. 31; Tr. 282-284. I find it highly unlikely that this was R1’s actual
pad. Compare P. Ex. 8, at 7 with P. Ex. 31; see Tr. 285-287, 292-295. In any event, the
pad is well worn, with holes in it, and I was able to detach its velcro holder using only a
pinky finger. Tr. 284.
15

According to Administrator Neely, in 18 years, “there has never been an accident
involving the vertical side rails or mattress gaps.” P. Ex. 10, at 1 (Neely Decl. § 8). But
facility incident reports suggest otherwise. Although the facility’s investigations and
reports provide incomplete information, they show that side rails were implicated in
multiple incidents involving resident injuries. For example, an incident report dated July
3, 2006, shows that Rl suffered an abrasion on his left leg above the knee (although the
body diagram indicates his right knee). A short note instructs staff to be “extra careful
when transferring resident with lift,” and “be careful not to bump resident on side rail.”
CMS Ex. 13, at 15. But the facility did not assess the risk of continued use of side rails,
nor explore alternatives. CMS Ex. 68, at 25 (LaMantia Decl. 4 78); see also Tr. 106. In
fact, when staff completed R1’s 30-day “restraint review” form on August 4, 2006, they
omitted any mention of the incident, cited no problems, and recommended “continue
[with] padded side rails.” CMS Ex. 13, at 4.

R5 was in a bed with the side rails up. On August 19, 2006, at about 8:10 a.m., his bed
alarm sounded. He had managed to get out of bed, and was urinating on the floor. CMS
Ex. 29, at 6. Staff did not consider the safety issue of his climbing out of bed, but
returned him to his bed and left his rails up. At 11:00 that night, his alarm went off again,
and they found him out of bed, on the floor, with the side rails still up. CMS Ex. 29, at 1;
Tr. 104-105.

Other incident reports suggest additional injuries, which staff suspected were related to
side rails. CMS Exs. 25, 27, 28. Yet, in none of these cases did the facility assess the risk
of continuing their use. Indeed, DON Russo conceded that it had not occurred to her that
side rail related injuries could be a problem. Tr. 192.

More troubling, the facility did not revisit its practices with respect to side rails, even
following R1’s death. That side rails were implicated in R1’s death is beyond doubt.

Every document generated by facility staff at the time of his death confirms that staff
found him lying on his right side, with his head, arm, and part of his shoulder caught

etween the side rails. He was blue. CMS Exs. 11; 13 at 1; 18; 22; 23. He died from
“positional asphyxia.” CMS Exs. 11; 12 at 1.

Petitioner’s efforts to cast doubt on that factual scenario are both unpersuasive and
irrelevant. They are unpersuasive because they rely on witnesses’ half-hearted and,
ultimately, not credible efforts to distance themselves from their earlier statements.

LPN James Winters, for example, was not able to provide a coherent explanation for the
discrepancies between the account he wrote at the time of the incident (he entered the
room and found R1 “on his [right] side, left arm and his head facing down caught in
right] sided side rail”) and his written declaration (he entered the room and found R1

16

“partly on his right side and partly face down in the area between the bed rail and the
mattress.”) Tr. 260-264; compare CMS Ex. 23 with P. Ex. 2 (Winters Decl. § 3).

Petitioner also presents declarations from the county deputy coroner and from the
attending pathologist for R1’s autopsy disavowing their earlier statements that R1 died
wedged between side rails, claiming instead that he died wedged between his mattress
and side rails. Under cross-examination, Pathologist Harold G. Ashcraft, M.D., admitted
to errors in his report, and conceded that R1 had marks on his neck likely caused by a
“firm object that was elongated ... such as a side rail.” Tr. 301-303. And, in testimony
that ranged from evasive to incredible, Deputy Coroner Jeffrey Lees failed to explain
why, long after the incident, he chose to disregard a// of the statements from the actual
eye witnesses in favor of vague suggestions from individuals (whom he did not
specifically name) who did not see the body until it was removed from the rails. See Tr.
307 et seq.

But the issue is irrelevant because, even if R1 had been caught between his bed rail and
mattress, the rails would have been equally implicated in his death, and should have
triggered a response from the facility. Remarkably, no one at the facility even considered

it necessary to re-examine its side rail practic
facility to act, the facility left its residents in
Agency that “[t]o prevent this from happenin.

es. Until these proceedings compelled the
eds with side rails. It reported to the State
g again to a resident in a similar situation, all

residents currently in house will be re-assessed for the need/or no need for siderails and/or

padded rails and careplans adapted as neede
surveyors arrived at the facility, no safety ass

Administrator Neely told the surveyors that t

.” CMS Ex. 10, at 2. But when the
essments had been performed.

e facility had changed the bed systems for

16 residents identified as suffering from seizure disorder. But when the surveyors looked

at six of those 16 residents (R9, R10, R11,R

5, R27, R28), their beds had not been

changed. CMS Ex. 68, at 15-16 (LaMantia Decl. § 47).

B. CMS’s determination that the facility’s deficiencies posed immediate
jeopardy was not clearly erroneous.

Immediate jeopardy exists if the facility’s noncompliance has caused or is likely to cause
“serious injury, harm, impairment, or death to a resident.” 42 C.F.R. § 488.301. CMS’s
determination as to the level of a facility’s noncompliance — which includes its immediate
jeopardy finding — must be upheld unless it is “clearly erroneous.” 42 C.F.R. § 498.60(c).
The Departmental Appeals Board has observed repeatedly that the “clearly erroneous”
standard imposes on facilities a “heavy burden” to show no immediate jeopardy, and has
sustained determinations of immediate jeopardy where CMS presented evidence “from
which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.” Barbourville
17

Nursing Home, DAB No. 1962, at 11 (2005) (citing Florence Park Care Center, DAB
No. 1931, at 27-28 (2004) (quoting Koester Pavilion, DAB No. 1750 (2000))).

Here, compelling evidence establishes that R1 died trapped between side rails, and I find
it more likely than not that Petitioner’s deficiencies contributed to his death. But I need
not even reach that conclusion in order to sustain the immediate jeopardy finding. So
long as the facility’s noncompliance “is likely to cause serious injury, harm [or]
impairment,” its deficiencies pose immediate jeopardy. Petitioner’s routine use of bed
rails without assessing their risks creates the likelihood of serious injury or harm.
Further, as Engineer Bruley explained, a bed system is unsafe if it presents excessive
gaps. P. Ex. 5, at 1 (Bruley Decl. § 6). Here, the facility routinely left its vulnerable
individuals in beds with widely spaced rails, without filling in any of the gaps. CMS’s
determination that such practices pose immediate jeopardy to resident safety was not
clearly erroneous.

C. The amount of the CMP — $5000 per day for the period of immediate
jeopardy and $100 per day for the period of noncompliance that was not
immediate jeopardy — is reasonable.

Having found a basis for imposing a CMP, I now consider whether the amount imposed is
reasonable, 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. 42 C.F.R. § 488.438(f). 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.

It is well-settled that, in reaching a decision on the reasonableness of the CMP, I may not
look into CMS’s internal decision-making processes. Instead, I consider whether the
evidence presented on the record concerning the relevant regulatory factors supports a
finding that the amount of the CMP is at a level reasonably related to an effort to produce
corrective action by a provider with the kind of deficiencies found and in light of the
other factors involved (financial condition, facility history, culpability). I am neither
bound to defer to CMS’s factual assertions, nor free to make a wholly independent choice
of remedies without regard for CMS’s discretion. Barn Hill Care Center, DAB No. 1848,
at 21 (2002); Community Nursing Home, DAB No. 1807, at 22 et seq. (2002); Emerald
Oaks, DAB No. 1800, at 9 (2001); CarePlex of Silver Spring, DAB No. 1683, at 8 (1999).
18

CMS has imposed a penalty of $5000 per day, which is toward the mid-range for
immediate jeopardy situations ($3050 — $10,000). It has imposed a penalty of $100 per
day for the remaining period of noncompliance, which is at the low end of the penalty
range ($50 — $3000). 42 C.F.R. § 488.438(a)(1).

The parties have provided me little assistance on this issue. Petitioner says only that it
was not culpable because it acted appropriately, which the evidence belies, as the above
discussion establishes. CMS, for its part, does not address the issue at all except to point
out that deficiencies involving side rail usage were cited in an earlier survey.

So, with respect to the facility history, CMS alleges that, in 2005, the State Agency cited
deficiencies based on problems with the facility side rails, and Petitioner has not denied
that assertion. CMS Ex. 68, at 3 (LaMantia Decl. § 11).

Petitioner has not argued that its financial condition affects its ability to pay the penalty.

With respect to the other factors, Petitioner’s deficiencies constituted a pattern of
noncompliance that posed immediate jeopardy to resident health and safety. I consider
this significant enough in scope and severity to warrant a substantial penalty. Moreover, I
disagree that the facility was not culpable. The evidence establishes that the facility
employed side rails without any serious regard for the risks they posed. Staff did not
assess safety considerations in its so-called assessments. In fact, those documents seemed
geared exclusively toward convincing examiners that the rails were not used as restraints.
Nor did staff ensure that the bed systems they used were as safe as possible. Even
following R1’s unfortunate death, the facility did not reexamine its practices. I find that
this level of culpability, as well as the scope and severity of the deficiencies, justify the
penalties imposed.

IV. Conclusion

For all of the reasons discussed above, I find that Petitioner was not in substantial
compliance with program participation requirements from August 22 through November
27, 2006. I find that from August 22 through 25, 2006, its deficiencies posed immediate
jeopardy to resident health and safety. I find reasonable the imposition of a $5000 per
day CMP for the period of immediate jeopardy, and a $100 per day CMP for the period of
substantial noncompliance that was not immediate jeopardy.

/s/
Carolyn Cozad Hughes
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
)
Danielle Lyn Timkovich, ) Date: May 27, 2008

)
Petitioner, )
)

-Vv.- ) Docket No. C-08-259

) Decision No. CR1793
The Inspector General. )
)

DECISION

Danielle Lyn Timkovich (Petitioner) appeals the decision of the Inspector General (I.G.),
made pursuant to section 1128(a)(3) of the Social Security Act (Act), to exclude her from
participation in Medicare, Medicaid, and all federal health care programs for a period of
five years. For the reasons discussed below, I find that the LG. is authorized to exclude
Petitioner. The five-year exclusion is the mandatory minimum period as a matter of law.

I. Background

The facts are not in dispute. In 2006, while working as an pharmacy intern at Kroger
Pharmacy in Sylvania, Ohio, Petitioner stole drugs from the pharmacy for her own
personal use. Petitioner Exhibit (P. Ex.) 1, at 6-8, 18-19; LG. Ex. 5. On June 1, 2006, she
pled guilty in Ohio State Court to six counts of felony theft by deception. Jd.

na letter dated December 31, 2007, the I.G. notified Petitioner that, because of the
felony conviction, she would be excluded from program participation for five years
pursuant to section 1128(a)(3) of the Social Security Act (Act). On January 23, 2008,
Petitioner filed a timely request for review, and the matter has been assigned to me for
resolution. The parties agree that this matter should proceed on their written submissions
and that an in-person hearing is not necessary. Order at 2 (March 5, 2008); Petitioner
Brief (P. Br.) at 6.

2

The parties have submitted their briefs. Attached to the I.G.'s brief are I.G. Exhibits (1.G.
Exs.) 1-7. Attached to Petitioner’s brief (P. Br.) are Petitioner Exhibits (P. Exs.) 1-3.
There being no objections, I.G. Exs. 1-7 and P. Exs. 1-3 are admitted into evidence.

II. Issue

The sole issue before me is whether the I.G. had a basis upon which to exclude Petitioner
from participation in the Medicare, Medicaid, and all federal health care programs. This
depends on whether the offenses for which she was convicted were “[i]n connection with
the delivery of a health care item or service.” 42 C.F.R. § 1001.101(c)(1) (2005). The
length of the period of exclusion is not an issue because the I.G. imposed the statutory
minimum.

Ill. Finding

Petitioner must be excluded for five years because she was convicted of a felony
relating to theft in connection with the delivery of a health care item, within the
meaning of section 1128(a)(3) of the Act.'

Under the statute and regulations, an individual convicted of felony theft in connection
with the delivery of a health care item must be excluded from participation in federal
health care programs for a minimum of five years. Act, § 1128(a)(3); 42 C.F.R.

§ 1001.101(c). Petitioner points out that she was found eligible for intervention in lieu of
conviction, but concedes that the state court determination nevertheless falls within the
statutory definition of “conviction.” P. Br. at 2.

Petitioner nevertheless argues that she was not convicted of any crime committed “[i]n
connection with the delivery of a health care item.” 42 C.F.R. § 1001.101(c)(1). She
recognizes the line of Departmental Appeals Board cases holding that theft of drugs by a
pharmacist from his employer constitutes theft in connection with the delivery of a health
care item, but characterizes as “overly broad” the Board’s reading of the statute. P. Br. at
5. In Petitioner’s view, she committed no crime with respect to the delivery of a health
care item because the drugs were store property that had not been prescribed to any
patient, and she kept them for her own personal use. Jd. I reject Petitioner’s strained
reading of the statute.

' T make this one finding of fact/conclusion of law to support my decision in this
case.
3

The Board’s reasoning in finding the requisite “common sense connection” in cases
involving theft by pharmacy employees has been as follows: the pharmacy obtains health
care items for the purpose of delivering them to members of the general public in order to
meet their medical needs. When an employee pharmacist takes one of those drugs, he
interferes with the delivery of that item. “[T]heft of [a] drug while under the guise of
performing his professional responsibilities is clearly the requisite common sense
‘connection’ to health care delivery that section 1128(a)(3) requires.” Erik D. DeSimone,
R.Ph., DAB No. 1932 at 3 (2004) (where the petitioner pled guilty to theft of a controlled
substance and paid $2,500 in restitution); see also, Kevin J. Bowers, DAB No. 2143
(2008); Robert F. Tschinkel, R.Ph., DAB CR1323 (2005); Thomas A. Oswald, R.Ph.,
DAB CR1216 (2004).

I find the Board’s reasoning sound. To accept Petitioner’s view, I would have to
conclude that pharmacies obtain and stock drugs for some purpose other than to deliver
them to consumers. I can think of no such purpose, and Petitioner has not suggested one.
She was convicted of stealing drugs intended for consumers, and her conduct therefore
falls within the ambit of section 1128(a)(3). I therefore sustain the exclusion.

IV. Conclusion

For these reasons, I conclude that the LG. has a basis for excluding Petitioner from
participation in Medicare, Medicaid, and all other federal health care programs, and I
sustain the five-year exclusion.

/s/
Carolyn Cozad Hughes
Administrative Law Judge