Liberty Commons Nursing v. Leavitt

UNPUBLISHED

UNITED STATES COURT OF APPEALS
FOR THE FOURTH CIRCUIT

No. 07-1329

LIBERTY COMMONS NURSING AND REHAB CENTER - ALAMANCE,

Petitioner,

v.

MICHAEL LEAVITT, Secretary of the United States Department of
Health & Human Services; U.S. DEPARTMENT OF HEALTH & HUMAN
SERVICES,

Respondents.

On Petition for Review of an Order of the United States Department
of Health & Human Services. (A-06-80)

Argued: March 20, 2008 Decided: July 18, 2008

Before GREGORY and SHEDD, Circuit Judges, and William L. OSTEEN,
Jr., United States District Judge for the Middle District of North
Carolina, sitting by designation.

Affirmed by unpublished per curiam opinion. Judge Shedd wrote a
dissenting opinion.

ARGUED: Joseph L. Bianculli, HEALTH CARE LAWYERS, P.L.C.,
Arlington, Virginia, for Petitioner. Donald J. Calder, UNITED
STATES DEPARTMENT OF HEALTH & HUMAN SERVICES, Office of the General
Counsel, Atlanta, Georgia, for Respondents. ON BRIEF: Daniel
Meron, General Counsel, Howard H. Lewis, Acting Regional Chief
Counsel, UNITED STATES DEPARTMENT OF HEALTH & HUMAN SERVICES,
Office of the General Counsel, Atlanta, Georgia, for Respondents.
Unpublished opinions are not binding precedent in this circuit.

2
PER CURIAM:

Liberty Commons Nursing and Rehab Center (“Petitioner”), seeks

review of a final decision by the Departmental Appeals Board

(“DAB”) of the U.S. Department of Health and Human Services

(“DHHS”). The DAB affirmed the imposition of a civil monetary

penalty (“CMP”) upon Petitioner for failure to be in substantial

compliance with federal regulatory standards governing

certification as a skilled nursing facility. This court has

“jurisdiction over the appeal of a final DAB decision pursuant to

42 U.S.C. § 1320a-7a(e).” Crestview Parke Care Ctr. v. Thompson,

373 F.3d 743, 746 (6th Cir. 2004); see also 42 U.S.C. §

1320a-7a(e); 42 C.F.R. § 498.90(a)(1). For the reasons set forth

below, we affirm the decision of the DAB.

I

Petitioner is a Medicare-certified nursing facility located in

Burlington, North Carolina. The certification signifies that

Petitioner has met the Long Term Care Requirements of Participation

(“ROP”), allowing it to participate in the Medicare Program for

Medicare and Medicaid funding.1 Facilities that participate in

this program are subject to annual inspections by the Centers for

1
The substantive requirements of participation are listed in
42 U.S.C. § 1395i-3.

3
Medicare and Medicaid Services2 (“CMS”), for the purpose of

determining a facility’s continued compliance with the ROPs.3

On November 11, 2004, the North Carolina State Survey Agency

(“SSA”) inspected Petitioner’s facility.4 Following the

inspection, the SSA cited Petitioner for a violation of 42 C.F.R.

483.25(h)(2), which is regulatory noncompliance that posed

“immediate jeopardy” to a single resident (“Resident”).5

Specifically, the violation stated that Petitioner “failed to put

interventions in place to prevent elopement of 1 of 1 sampled

residents.” (J.A. 1.) As a result of the SSA’s finding, the

Secretary of the DHHS imposed upon Petitioner a CMP. Petitioner

applied to the DAB for a review of the imposition of the CMP.

During an oral administrative hearing, an administrative law judge

2
Centers for Medicare and Medicaid Services is an agency of
the federal Department of Health and Human Services that is in
charge of administering the Medicare program. See MacKenzie Med.
Supply, Inc. v. Leavitt, 506 F.3d 341, 343 (4th Cir. 2007). It
operates as an agent of the Secretary of DHHS.
3
All participating facilities are subject to annual state
surveys to determine if they comply with the Medicare and Medicaid
participation requirements. 42 U.S.C. § 1395i-3(g)(2)(A)(iii)(I).
4
The Secretary of the Department of Health and Human Services
is permitted by statute to enter into agreements with state
agencies; for example the North Carolina State Department of Health
and Human Services. Such agreements allow a state agency (the SSA)
to act as an agent of the Secretary. See 42 U.S.C. § 1395aa. In
this case, an agreement existed that enabled the SSA to conduct
surveys for the purpose of determining Petitioner’s compliance with
federal regulations.
5
Regulatory noncompliance with 42 C.F.R. 483.25(h)(2) is also
commonly referred to within the DHHS as a violation of F Tag 324.

4
(“ALJ”) made the following findings of fact, which we adopt in

their entirety as they are not disputed on appeal.

A. Administrative Law Judge’s Findings of Fact

Prior to May 2003, Petitioner operated a locked wing in its

facility, referred to as the Special Care Unit. Resident, an 87-

year-old woman with severe Alzheimer’s disease and osteoporosis,

was housed in Petitioner’s Special Care Unit from September 2000

until May 2003 due to her “high risk for elopement as the result of

her numerous medical and psychological ailments.” (J.A. 370.)

In May 2003, Petitioner converted the Special Care Unit to a

rehabilitation unit. The new unit did not provide the same level

of services and security as that of the Special Care Unit.

Accordingly, Petitioner advised Resident’s family about the need to

move Resident to another facility. The family urged Petitioner to

allow Resident to remain at her current location. Despite

Petitioner’s concerns, Petitioner reluctantly allowed Resident to

remain at the facility. During Resident’s stay in the

rehabilitation unit, she eloped on several occasions.6

Petitioner documented in writing each time Resident eloped.

The first time Resident eloped was June 2, 2003, when she simply

walked out of Petitioner’s facility. To prevent future elopements,

6
According to the record before the court, Resident began to
elope on June 2, 2003, less than a month after moving into the new
unit. Petitioner documented five additional elopements which
occurred on June 23, August 14, September 19, November 6, and
November 7, 2004.

5
Petitioner placed a Wander Guard transponder on Resident’s ankle

that would trigger an alarm if Resident eloped through the front

door. Other doors, however, were not equipped with a Wander Guard

alarm. Despite this precaution, Resident managed to elope

undetected through exit doors other than the front door.

On September 19, 2004, Petitioner became aware of the manner

in which Resident eloped without detection. Another resident

observed Resident flip a bypass switch that disabled an electronic

door lock and allowed Resident to exit through a back door.7

Petitioner located Resident on this date after she had wandered

through a fence, down a grassy slope, and into a parking lot. In

response to Resident’s actions, Petitioner placed pieces of paper

over the bypass switches in an attempt to confuse or distract her.8

On November 6, 2004, Resident, undeterred by the paper-covered

switches, again disabled the electronic lock and eloped through the

rear exit doors. The following day, Resident also attempted to

elope through the front door, but her Wander Guard triggered an

alarm and she was promptly retrieved by two visitors.

7
All of Petitioner’s doors were controlled by electronic
locks. No door, with the exception of the front door, was equipped
with an alarm system that would alert the staff in the event that
a resident exited the facility.
8
Petitioner has argued that “distraction” is a common method
of deterring conduct by residents with Alzheimer’s disease.
Although an untested technique in this context, Petitioner placed
paper over the bypass switches in order to distract her from
operating the bypass switches.

6
 B. The Centers for Medicare and Medicaid Services Inspection

On November 11, 2004, the SSA conducted an annual inspection

of Petitioner’s facility and sent its findings to CMS. After the

inspection and review of Petitioner’s records and facility, termed

a “survey,” CMS found that Petitioner failed to comply with federal

regulations governing care facilities approved for Medicare and

Medicaid funding, and imposed a CMP. Specifically, CMS found that

Petitioner was not operating in substantial compliance with nursing

home regulations that require facilities to provide adequate

supervision of its residents to prevent accidents.

CMS found that Petitioner was not in compliance because

Petitioner had failed to take appropriate steps to prevent Resident

from repeatedly eloping from its facility. (J.A. 5.) As a result

of CMS’s inspection, Petitioner decided to install squeal boxes

(alarms) on the bypass switches to alert the staff when a bypass

switch was activated. The squeal boxes were installed on November

16-17 and were fully operational on November 19, 2004. CMS

conducted a follow-up survey on November 18, 2004, after which CMS

determined that Petitioner’s noncompliance constituted “immediate

jeopardy” from the date Petitioner was aware of Resident’s means of

elopement, September 19, 2004, until the squeal boxes were

installed on November 17, 2004. Additionally, CMS found that

Petitioner’s noncompliance continued at a level below immediate

jeopardy from the time the squeal boxes were installed until the

7
staff was trained on how to respond to the alarms on November 18,

2004. Accordingly, Petitioner was fined $3,050 per day from

September 19, 2004 through November 17, 2004, and $50 per day on

November 18, 2004, resulting in a total fine of $180,000.9

C. The DAB Proceeding

Following CMS’s imposition of fines, Petitioner requested an

administrative review of the CMP by the DAB. As provided by

statute, the DAB afforded Petitioner a hearing before an ALJ. The

ALJ conducted a hearing on December 15, 2005, and affirmed CMS’s

findings. Petitioner then appealed the ALJ’s decision to the

Appellate Division of the DAB.10 The DAB Appellate Division

reviewed and affirmed the ALJ’s decision. This case is now before

this court on appeal of the final decision of the DAB.

Standard of Review

In this case, the Secretary of DHHS (“Secretary”)11 made

findings of fact to support the conclusion that Petitioner was not

9
There is great discrepancy within the various documents
before the court as to the amount of the fine. The total amount
should be $180,000. This represents a fine of $3,050 each day from
September 19 - November 17 (59 days) and a fine of $50 on November
18 (1 day): 59 x $3,050 = $179,950 and 1 x $50 = $50. $50 +
$179,950 = $180,000.
10
Initially, Petitioner moved to reopen the case in order to
submit additional evidence, but the request was denied.
11
For the purposes of this opinion, the decision of CMS will
be treated as that of the Secretary.

8
in substantial compliance with 42 C.F.R. § 483.25(h)(2), and that

such noncompliance resulted in both immediate jeopardy and the

potential for minimum harm. We review the Secretary’s factual

findings to determine if they are supported by substantial

evidence. 42 U.S.C. § 1320a-7a(e) (“The findings of the Secretary

with respect to questions of fact, if supported by substantial

evidence on the record considered as a whole, shall be

conclusive.”). Substantial evidence is “such relevant evidence as

a reasonable mind might accept as adequate to support a

conclusion.” Richardson v. Perales, 402 U.S. 389, 401, 91 S. Ct.

1420, 1427 (1971) (citation and internal quotations omitted). This

level of evidence is further defined as “more than a mere scintilla

of evidence but may be somewhat less than a preponderance.” Laws

v. Celebrezze, 368 F.2d 640, 642 (4th Cir. 1966). The Secretary’s

legal conclusions are subject to a highly deferential standard of

review. By regulation, a determination of noncompliance must be

upheld unless that decision is clearly erroneous. See 42 C.F.R. §

498.60(c)(2).

Governing Regulations: Adequate Supervision and Assistance

This case is governed by regulations set forth in the Code of

Federal Regulations, which provides standards to which nursing

homes must conform in order to qualify for participation in

Medicare and Medicaid funding. The regulation at issue in this

9
case, 42 C.F.R. § 483.25(h)(2), states that a facility must ensure

that “[e]ach resident receives adequate supervision and assistance

devices to prevent accidents.” 42 C.F.R. § 483.25(h)(2). An

“‘accident’ is defined in the State Operations Manual (SOM) issued

by HCFA as ‘an unexpected, unintended event that can cause a

resident bodily injury.’” Woodstock Care Ctr. v. Health Care Fin.

Admin., DAB No. 1726 (May 30, 2000) (citation omitted).12 In order

for a facility to be in substantial compliance with this

regulation, “a provider must have no deficiencies that pose a risk

to resident health or safety greater than ‘the potential for

causing minimum harm.’” Id. (citing 42 C.F.R. § 488.301).

In this case, the Secretary found that Petitioner failed to

adequately supervise Resident in order to prevent her from eloping,

in violation of 42 C.F.R. § 483.25(h)(2). The Secretary found that

Petitioner failed to take all reasonable steps necessary to secure

its exit doors after discovering Resident’s ability to flip the

bypass switches and exit the building undetected. Petitioner

argues that its electronic door locks were state-of-the-art and

were installed within parameters dictated by state law.

As a participant in Medicare and Medicaid funding, Petitioner

is obligated to ensure that “[e]ach resident receives adequate

supervision and assistance devices to prevent accidents.” 42

12
The Health Care Financing Administration or HCFA has been
reorganized into the Centers for Medicare and Medicaid Services.

10
C.F.R. § 483.25(h)(2). The regulation directs a facility to take

all reasonable precautions to prevent situations that have the

potential for causing harm to a resident. See Woodstock Care Ctr.

v. Thompson, 363 F.3d 583, 589 (6th Cir. 2003). Petitioner, as of

September 19, 2004, knew that Resident could disable the electronic

door locks and exit the facility undetected. Accordingly,

Petitioner had no means of adequately supervising Resident or

preventing accidents once she exited the facility undetected.

Petitioner challenges the Secretary’s determination,

contending that Resident’s elopements were few and far between, and

resulted in no injury. Contrary to Petitioner’s assertion,

however, substantial evidence supports the Secretary’s finding of

a failure to adequately supervise and prevent accidents. It is

uncontested that Resident was able to elope from Petitioner’s

facility undetected despite the fact that Petitioner knew Resident

was eloping by flipping the bypass switch and exiting through the

back door. This knowledge placed Petitioner on notice and

obligated Petitioner to take steps necessary to adequately

supervise Resident. Additionally, the fact that Resident eloped

multiple times undetected after September 19, 2004, also provides

substantial evidence in support of the Secretary’s findings. See

Woodstock Care Ctr. V. Health Care Fin. Admin., DAB No. 1726 (May

30, 2000) (The ALJ held that “evidence which shows that residents

were able to escape Petitioner’s facility on multiple occasions, is

11
ample evidence of a lack of supervision of these residents.”).

Substantial evidence, therefore, supports a finding that Petitioner

was not in substantial compliance with 42 C.F.R. § 483.25(h)(2).

Petitioner further contends that Resident’s lack of an injury

during her elopements compels a conclusion that she was adequately

supervised. The fact that no injury occurred while Resident

eloped, however, is not factually dispositive on the issue of

adequate supervision. The absence of an injury does not indicate

whether Resident was adequately supervised or merely fortunate. In

this case, the Secretary analyzed the fact that Resident was an

elderly woman who ambulated using a walker and was at a high risk

for experiencing falls, and came to the conclusion that her

exposure to the outdoor terrain put her in immediate jeopardy of

sustaining an injury. Substantial evidence supported the

Secretary’s conclusion that Resident’s ability to avoid an injury

was completely fortuitous.

Immediate Jeopardy

Petitioner challenges the Secretary’s conclusion that

Petitioner’s noncompliance rose to the level of immediate jeopardy.

The federal regulations governing inspections of nursing facilities

classifies noncompliance violations based on the severity of risk

to a resident. Immediate jeopardy is defined as “a situation in

which the provider’s noncompliance with one or more requirements of

12
participation has caused, or is likely to cause, serious injury,

harm, impairment, or death to a resident.” 42 C.F.R. § 488.301.

The second level of noncompliance is defined as a situation where

there is “[n]o actual harm with a potential for more than minimal

harm, but not immediate jeopardy.” 42 C.F.R. § 488.404(b)(1)(ii).

The lowest level violation is found when there is “[n]o actual harm

with a potential for minimal harm.” 42 C.F.R. § 488.404(b)(1)(I).13

The Secretary determined that Resident’s ability to elope

undetected resulting in unsupervised exposure to areas beyond the

confines of the facility walls constituted immediate jeopardy. We

are required to uphold this determination unless we find it to be

clearly erroneous. See Liberty Commons Nursing & Rehab Ctr. -

Johnston v. Leavitt, 241 Fed. Appx. 76, 81 (4th Cir. 2007)

(unpublished) (citing 42 C.F.R. § 498.60). In reviewing the facts,

the ALJ determined that Resident’s advanced age, Alzheimer’s

disease, and debilitating physical condition put her at risk of,

inter alia, falling down, getting lost, or being hit by a car in

the parking lot. In evaluating these potential consequences, the

ALJ concluded that the elopements were likely to cause serious

13
The level of infraction determines the civil penalty. In
situations deemed to constitute immediate jeopardy, “[p]enalties in
the range of $3,050 - $10,000 per day are imposed.” 42 C.F.R. §
488.438(a)(1). Likewise, “[p]enalties in the range of $50 - $3,000
per day are imposed for deficiencies that do not constitute
immediate jeopardy, but either caused actual harm, or caused no
actual harm, but have the potential for more than minimal harm.”
Id. § 488.438(a)(2).

13
injury or harm to Resident. The Secretary’s conclusion is not

clearly erroneous because patients suffering from conditions

similar to Resident’s have wandered from their facility and been

involved in accidents. See Golden Villa Nursing Home, Inc. v.

Smith, 674 S.W.2d 343 (Tex. App. 1984) (resident who eloped was hit

by person on motorcycle); Lincoln Manor, Inc. v. Dep’t of Pub.

Health, 832 N.E.2d 956, 358 Ill. App. 3d 1116 (2005) (resident

eloped from facility and sustained a fractured hip as a result of

a fall); Ostrom v. Manorcare Health Servs., 2007 U.S. Dist. LEXIS

4106 (E.D. Mich. Jan. 22, 2007) (resident with Alzheimer’s disease

who eloped suffered severe head trauma after tripping over a light

post). Moreover, the fact Resident eloped on multiple occasions

lends more strength to the ALJ’s conclusion. See Woodstock Care

Ctr. v. Thompson, 363 F.3d 583, 590 (6th Cir. 2003) (The court, in

considering the frequency of the residents’ elopements as well as

“the vulnerable state of the residents, and the dangers of the

outside world to residents in such a state,” held the conclusion

that the residents’ “elopements would likely cause serious injury

was supported by substantial evidence.”).

Petitioner further claims that the Secretary’s conclusion is

unfounded for two reasons: (1) because Petitioner undertook

certain efforts to prevent Resident from eloping, and (2) because

Resident never sustained any injury while outside the facility.

These arguments are without merit, however, because the Secretary

14
can make a finding of immediate jeopardy notwithstanding a

facility’s attempt to take remedial measures or the lack of an

actual injury to a resident.

The purpose of the regulation, 42 C.F.R. § 483.25(h)(2), is to

prevent not only actual harm, but also likely harm to a resident.

Therefore, a facility is to take all reasonable precautions to

prevent unintended events that can cause a resident bodily injury.

Woodstock, 363 F.3d at 589. “The question whether [a facility]

took all reasonable precautions is highly fact-bound and can only

be answered on the basis of expertise in nursing home management.

As such, it is a question the resolution of which we defer to the

expert administrative agency.” Id.

Petitioner’s Responses to Resident’s Elopements

Petitioner claims that this court should reverse the

Secretary’s decision to impose a CMP because Petitioner attempted

to take remedial measures to prevent Resident from continuing to

elope. Specifically, Petitioner challenges the Secretary’s

determination that Petitioner’s attempts were not sufficient. In

evaluating a facility’s response to a risk of harm to a resident,

courts focus on whether a facility “had taken reasonable steps to

respond to the residents’ need for supervision.” Woodstock Care

Ctr. V. Health Care Fin. Admin., DAB No. 1726 (May 30, 2000). This

“regulatory standard does not amount to strict liability or require

15
absolute success,” as there is “an element of reasonableness [that]

is inherent in the regulation’s requirements.” Crestview Parke

Care Ctr. v. Thompson, 373 F.3d 743, 754 (6th Cir. 2004) (citation

and internal quotations omitted). The standard does require,

however, that a facility do more than simply respond to a problem,

because it imposes a burden of taking “all reasonable precautions.”

Woodstock, 363 F.3d at 589. DAB tribunals interpret this to mean

that “a facility is not required to do the impossible or be a

guarantor against unforeseeable occurrence, but is required to do

everything in its power to prevent accidents.” Koester Pavilion

Petitioner v. Health Care Financing Administration, DAB No. 1750

(Oct. 18, 2000).

In order to determine whether Petitioner’s responses were

reasonable, this court looks at two factors: whether a risk of an

“accident” was foreseeable and whether the facility’s response was

adequate under the circumstances. See Woodstock Care Ctr. V.

Health Care Fin. Admin., DAB No. 1726 (May 30, 2000). In this

case, Petitioner learned on September 19, 2004, that Resident was

flipping the bypass switches and walking out the exit doors.

Despite Resident’s unique ability to operate the switches, all of

Resident’s future elopements became foreseeable the moment

Petitioner realized Resident was capable of operating the bypass

switches.

16
 Petitioner’s reaction to Resident’s behavior was not adequate

because it was not tailored to address her relatively high

functional capacity. In order to prevent Resident from eloping,

Petitioner placed paper covers over the switches that release the

locks on the exit doors. Petitioner claimed that this would

confuse and distract Resident, thus preventing her from locating

the switches. The Secretary did not consider this response to be

adequate under the circumstances and substantial. We agree.

When deciding to cover the bypass switches with paper,

Petitioner did not consider Resident’s “novel talent for operating

the bypass switches.” (P.B. at 43.) Though Petitioner’s tactics

might have worked on less functional Alzheimer’s patients,

Petitioner should have employed measures designed to prevent

someone with Resident’s level of cognitive ability from operating

the bypass switches. At the very least, Petitioner could have

initially combined the paper covers with a proven measure, such as

one-on-one supervision to analyze whether the paper covers were

effective.14 Assuming such measures were not feasible, Petitioner’s

actions still never addressed the ultimate problem, Resident’s

14
The applicable regulations require Petitioner to take all
reasonable precautions to prevent accidents. See, 42 C.F.R. §
483.25(h)(2). Petitioner contends that one-on-one supervision as
suggested by the ALJ and DAB Appellate Board compromises a
resident’s dignity, and is therefore not a preferred method of
supervision. Petitioner, however, provides no authority to support
a conclusion that safeguarding a resident’s dignity or independence
is preferred to protecting a resident against accidents.
Accordingly, we find no merit in Petitioner’s position.

17
ability to exit the facility without detection. Considering the

other possible responses available and known to Petitioner at that

time, including the use of the Wander Guard alarm or full-time,

one-on-one supervision, Petitioner cannot claim that covering the

switches with paper was reasonable.

This conclusion is further supported by the fact that Resident

was previously housed in a locked unit. In assessing the proper

level of care required for Resident, Petitioner acknowledged that

she was at a high risk for elopement. This risk did not decrease

when she moved to an unlocked unit; in fact, her risk of elopement

increased. Petitioner’s reply brief admits that its staff “knew

that they could not assure the Resident’s safety on an open,

unlocked unit.” (P.R. 15.) Furthermore, Petitioner states that it

was the staff’s professional judgment that Resident required

greater supervision in an unlocked unit. Id. Accordingly,

Petitioner cannot show that the Secretary’s findings were not

supported by substantial evidence or that his legal conclusions

were clearly erroneous.

Resident Suffered No Actual Harm

Petitioner’s argument that Resident never sustained any actual

injury during her elopements is not a proper basis to set aside the

Secretary’s finding of immediate jeopardy. In fact, the DAB has

“held that the regulations do not require any finding of actual

18
harm to justify a determination that immediate jeopardy to

residents exists.” Southridge Nursing and Rehab. Ctr. v. Health

Care Fin. Admin., DAB No. 1778 (July 30, 2001) (citation and

internal quotations omitted). According to the plain language of

the regulation, a finding of immediate jeopardy only requires that

a nursing facility’s noncompliance is likely to cause harm to a

resident. See 42 C.F.R. § 488.301. As mentioned above, Resident’s

condition made her likely to suffer harm if unsupervised outside of

Petitioner’s facility. This is not a case where a resident eloped

a single time, or where the resident was retrieved immediately upon

her decision to exit. Here, Resident continued to exit the

facility without the staff’s knowledge. Additionally, on at least

two occasions, the staff was unsure how long Resident had been

outside the facility. The fact that she eloped on numerous

occasions increased the possibility that she would suffer an

injury. See Woodstock Care Ctr. v. Thompson, 363 F.3d 583, 590

(2003) (“Even in the absence of ‘actual harm,’ a ‘widespread

potential for more than minimal harm’ is sufficient to sustain the

CMP.”) (citing 42 C.F.R. § 488.301). Therefore, Petitioner’s

argument that Resident always found her way back to the facility

unharmed is not persuasive. See Southridge, DAB No. 1778 (July 30,

2001) (“Just because the resident fortuitously did not suffer any

actual harm does not eliminate the likelihood that harm could have

19
befallen him in the course of his time outside.”). Accordingly, we

affirm the Secretary’s determination of immediate jeopardy.

Due Process

Petitioner claims it was deprived of procedural rights during

the hearing before the ALJ because the Secretary changed its reason

for imposing a CMP and the ALJ thereafter denied Petitioner an

opportunity to submit additional evidence through direct witness

testimony. Because we find Petitioner’s argument to lack merit, we

will not upset our decision to affirm the rulings below.

Petitioner notes that the DAB lacks uniform rules for

conducting a hearing to review the imposition of a CMP instead

allowing the ALJs to use their discretion setting the procedure for

a hearing. The Medicare Act at (42 U.S.C. § 1395i-3(h)(2)(B)(ii))

specifically grants discretion to the Secretary to conduct CMP-

related proceedings by incorporating by reference 42 U.S.C. §

1320a-7a(c)(4). Under 42 C.F.R. § 498.60, the discretion regarding

hearing procedures is passed along to the ALJ. In this case, the

presiding ALJ issued an initial order outlining the procedures to

be used for the hearing. The order requested that the parties

submit written direct testimonial evidence of all potential

witnesses to be used at the hearing, and to make these witnesses

available for cross-examination during the hearing. (J.A. 41-42.)

Once this prehearing exchange was complete, neither party could

20
supplement its evidence unless it made a motion to do so. (J.A.

40.)

In accordance with the ALJ’s directives, CMS submitted a brief

and direct testimony of its surveyor in May 2005. Approximately 30

days later, Petitioner responded by submitting direct witness

testimony and a prehearing brief. After Petitioner’s submission,

CMS moved to supplement its evidence with additional testimony of

the surveyor in rebuttal to certain claims made by Petitioner’s

employees. The ALJ granted this motion. Petitioner did not

supplement or amend its evidence.15

Petitioner claims it was prejudiced by the ALJ’s procedures

regarding witness testimony. Specifically, Petitioner claims that

it was denied the opportunity to supplement its case with

additional testimony regarding the efficacy of its electronic door-

locking system because the ALJ’s rules prevented witnesses from

testifying at the hearing unless they were cross-examined. The

record, however, shows that the only obstacle Petitioner faced in

submitting additional evidence was its own failure to organize and

submit such evidence. The record shows both that the ALJ granted

Petitioner’s motion to supplement (J.A. 134-35), and that

Petitioner failed to submit additional evidence. (J.A. 526). We

15
Petitioner did make a motion to submit supplemental evidence
in the form of direct testimony of Randy Warden, the installer of
Petitioner’s alarm system. The ALJ granted this motion, but
Petitioner never submitted any additional materials.

21
fail to see how the Petitioner’s procedural due process rights were

prejudiced by the ALJ’s procedures.

Even assuming that Petitioner proffered the direct witness

testimony it claims was wrongly omitted from the ALJ’s

consideration, this evidence would not have affected the ALJ’s

analysis. Petitioner sought to submit testimony of Randy Warden,

the installer of Petitioner’s door-locking system, in an attempt to

show that the system Petitioner installed was the one preferred by

the State of North Carolina and conformed to all the Life Safety

Code requirements. Such testimony, however, was irrelevant to the

determination of whether Petitioner was in substantial compliance

with the regulation requiring adequate supervision of its

residents. Though the electronic locking system may have been

state-of-the-art at the time, the system was still unable to alert

Petitioner’s staff of Resident’s elopements. This required

Petitioner to take additional steps to monitor Resident and prevent

her from eloping undetected. Accordingly, this evidence was

irrelevant to the determination that Petitioner was not in

substantial compliance with 42 C.F.R. § 483.25(h)(2).

The remainder of Petitioner’s procedural due process arguments

are also without merit. Petitioner’s attempt to analogize its case

to Crestview Parke Care Ctr. v. Thompson, 373 F.3d 743, 749 (6th

Cir. 2004), is unpersuasive because Petitioner was afforded an oral

hearing and was given an opportunity to present its case, and the

22
Secretary did not rely on any post hoc rationalizations to support

its contention that Petitioner failed to adequately supervise

Resident. Petitioner, therefore, suffered no prejudice nor injury

from the ALJ’s hearing procedures.

Conclusion

For the reasons set forth above, the final judgment of the DAB

is

AFFIRMED.

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SHEDD, Circuit Judge, dissenting:

Liberty Commons must comply with 42 C.F.R. § 483.25(h), which

provides: “Accidents. The facility must ensure that . . . (2) each

resident receives adequate supervision and assistance devices to

prevent accidents.” In interpreting this regulation, the DAB has

held a facility is not subject to strict liability but a

reasonableness standard, requiring that a facility take all

“reasonable steps to respond to the residents’ need for

supervision.” Woodstock Care Ctr. v. Healthcare Fin. Admin., DAB

No. 1726 (May 30, 2000).*

Liberty Commons claims that it met the DAB’s reasonableness

standard by responding to Resident #2's (“the Resident”) continued

elopements by increasing remedial measures to prevent future

elopements. The last of these remedial measures involved the

covering of door lock override switches with paper, a step taken to

prevent the Resident from operating the switches to unlock exit

doors by diverting her attention. After Liberty Commons covered

the switches with paper, the Resident did not elope for a period of

approximately six weeks.

*
The DAB also interprets the regulation to mean that “a
facility is not required to do the impossible or be a guarantor
against unforeseeable occurrences, but is required to do everything
in its power to prevent accidents.” Koester Pavilion v. Healthcare
Fin. Admin., DAB No. 1750 (Oct. 18, 2000). Clearly, though, the
DAB does not apply this interpretation literally. Doing so would
result in a violation in every case because some further step to
prevent accidents is always available.

24
 Under the DAB’s interpretation of § 483.25(h), Liberty

Commons’ actions should have been analyzed for reasonableness. The

agency, however, failed to do so. The state surveyor who inspected

Liberty Commons’ facility testified that she did not evaluate the

reasonableness of the paper covers because the resident “was still

getting out of the facility. It was a non-issue.” J.A. 259.

Likewise, the ALJ did not address this remedial measure. Only the

DAB did so, and its analysis failed to comply with its own

announced standards.

The DAB found that Liberty Commons’ response was not

“reasonable and effective” because it ultimately failed to keep the

Resident from eloping. However, the DAB never analyzed the

reasonableness of Liberty Commons’ remedial steps but focused its

discussion solely on their effectiveness. In other words, the DAB

failed to consider the possibility that a facility can take

appropriate, reasonable steps to prevent accidents which in the end

prove ineffective. Thus, the DAB engaged in no reasonableness

analysis at all but simply an effectiveness analysis. Such an

analysis for “effectiveness” is simply an application of strict

liability, in violation of the DAB’s standards.

Because there is some evidence in the record indicating that

Liberty Commons acted reasonably to prevent the Resident’s

elopements, I would vacate and remand for further consideration

using a proper reasonableness analysis.

25