Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
)
National Rehab Services, Inc., )
(CCN: 23-6772) ) Date: September 16, 2008
)
Petitioner, )
)
-Vv.- ) Docket No. C-07-14

) Decision No. CR1840
Centers for Medicare & Medicaid )
Services. )
)

DECISION

I sustain the determination of the Centers for Medicare and Medicaid Services (CMS) to
terminate National Rehab Services, Inc.’s (Petitioner or facility) provider agreement for
failure to comply substantially with federal requirements governing participation of
outpatient rehabilitation facilities in Medicare and State Medicaid programs. For the
reasons that follow, I uphold termination of Petitioner’s participation from Medicare and
Medicaid programs, effective August 19, 2006.

I. Background

This case is before me pursuant to a request for hearing filed by Petitioner dated
September 14, 2006. Petitioner is an outpatient physical therapy provider located in
Taylor Michigan.

By letter dated May 23, 2006, CMS informed Petitioner that based on a re-certification
survey conducted by the Michigan Department of Community Health (State Agency) on
March 15, 2006, and a revisit completed by the State Agency on April 20, 2006, it was
terminating Petitioner’s participation in the Medicare program effective June 23, 2006,
due to Petitioner’s failure to be compliant with the conditions of participation for
outpatient physical therapy facilities. During those surveys, Petitioner was cited for
noncompliance with six conditions of participation and noncompliance with five
conditions of participation, respectively. Petitioner had previously submitted a plan of
correction to CMS addressing the noncompliance cited in the March survey and on May
31, 2006, Petitioner submitted a plan of correction to CMS addressing the noncompliance
cited in the April survey. On July 19, 2006, CMS sent Petitioner a notice accepting
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Petitioner’s plan of correction and notified Petitioner that it was administratively
extending Petitioner’s termination from June 23, 2006 to August 19, 2006. On August 7,
2006, the State Agency completed a revisit survey and found that Petitioner was still out
of compliance with the Program Evaluation condition of participation (42 C.F.R.

§ 485.729). By letter dated August 18, 2006, CMS notified Petitioner that its Medicare
provider agreement would be terminated effective August 19, 2006, and that Petitioner
was informed of its appeal rights in CMS’s May 23, 2006 letter. By letter dated
September 14, 2006, Petitioner requested a hearing to contest whether its citation for
noncompliance with 42 C.F.R. § 485.729 (Program Evaluation) warrants a condition level
deficiency.

On April 2, 2008, Petitioner and CMS submitted its “Joint Statement Waiving In-Person
Hearing.” By Order dated April 5, 2008, I vacated the April 8, 2008 hearing date
scheduled for this case and instructed the parties to submit a written brief (CMS Br. and
P. Br.), witness declarations and proposed exhibits by May 8, 2008, and simultaneous
replies (CMS Reply and P. Reply) by May 23, 2008. Along with CMS’s brief, CMS
offered 7 exhibits, identified as CMS Exhibits (Exs.) 1-7. I receive CMS Exs. 1-7 into
evidence without objection. Along with Petitioner’s brief, Petitioner offered 1 exhibit,
identified as P. Ex. 1. [receive P. Ex. 1 into evidence without objection.

Based on the documentary evidence, the arguments of the parties, and the applicable law
and regulations, I find that Petitioner was not in compliance with 42 C.F.R. § 485.729
(Program Evaluation), on the date determined by the State Agency and CMS. I further
find that CMS was authorized to terminate Petitioner for non-compliance of this
Condition of Participation, effective August 19, 2006.

If. Applicable Law and Regulations

Petitioner is considered a rehabilitation facility that provides outpatient physical therapy
services (outpatient physical therapy facility) under the Social Security Act (Act) and
regulations promulgated by the Secretary of Health and Human Services (Secretary). The
statutory requirements for participation by a provider of outpatient physical therapy
services are found at section 1861(p) of the Act, and at 42 C.F.R. Part 485, Subpart H.
Section 1861(p)(4) of the Act specifies that rehabilitation facilities that provide outpatient
physical therapy services participating in Medicare and Medicaid programs must meet
and maintain certain conditions of participation. These conditions of participation are
further promulgated in 42 C.F.R. Part 485, Subpart H.

Facilities that participate in Medicare may be surveyed on behalf of CMS by state survey
agencies in order to determine whether the facilities are complying with federal
participation requirements. 42 C.F.R. §§ 488.10-488.28; 42 C.F.R. §§ 488.300 - 488.335.
Pursuant to 42 C.F.R. Part 488, CMS may determine that an institution or agency does
not qualify for participation in the Medicare or Medicaid programs or coverage because it
is not in compliance with the conditions of participation or the conditions of coverage. 42
C.F.R. § 488.24. The regulations provide that CMS may terminate the agreement with
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any provider if CMS finds that the provider no longer meets the conditions of
participation. 42 C.F.R. § 489.53(3).

In provider appeals under 42 C.F.R. Part 498, the Departmental Appeals Board has
determined that CMS must make a prima facie case that an entity has failed to comply
substantially with federal requirements. See MediSource Corporation, DAB No. 2011
(2006). “Prima facie” means that the evidence is “[s]ufficient to establish a fact or raise a
presumption unless disproved or rebutted.” Black’s Law Dictionary 1228 (8" ed. 2004);
see also Hillman Rehabilitation Center, DAB No. 1611, at 8 (1997), aff'd, Hillman
Rehabilitation Center v. U.S. Dept. of Health and Human Services, No. 98-3789 (GEB)
(D.N.J. May 13, 1999). Once CMS has established its prima facie case, the entity must
overcome CMS’s showing by a preponderance of the evidence. Batavia Nursing and
Convalescent Center, DAB No. 1904 (2004); Batavia Nursing and Convalescent Inn,
DAB No. 1911 (2004); Emerald Oaks, DAB No. 1800 (2001); Cross Creek Health Care
Center, DAB No. 1665 (1998); Hillman, DAB No. 1611 (1997).

The Act and regulations make a hearing before an ALJ available to a provider against
whom CMS has terminated its provider agreement. But the scope of such hearings is
limited to whether an initial determination made by CMS is correct. 42 C.F.R.

§ 498.3(b)(8). The hearing before an ALJ is a de novo proceeding. Anesthesiologists
Affiliated, et al., DAB CR65 (1990), aff'd 941 F.2d 678 (8" Cir. 1991). An ALJ may
review the basis for CMS’s imposition of remedies, however, the choice of remedies by
CMS or the factors CMS considered when choosing remedies are not subject to review.
42 C.F.R. § 498.3(b)(11); see also Belmont Nursing & Rehab Ctr. v. HCFA, DAB CRS507
(1997).

Ill. Issue

Whether the facility was not in compliance with conditions of participation for
outpatient physical therapy facilities.

IV. Findings and Discussion

The findings of fact and conclusions of law noted below, in italics, are followed by a
discussion of each finding.

A, Petitioner was not in compliance with Medicare conditions of participation
for 42 C.F.R. § 485.729 (Program Evaluation) during the August 7, 2006
Survey.

Subpart H of 42 C.F.R. Part 485 implements section 1861(p)(4) of the Act which defines
outpatient physical therapy and imposes requirements on facilities offering this service
with respect to adequate program, facilities, policies, staffing, and clinical records. 42
C.F.R. § 485.701. Several conditions of participation for rehabilitation agencies as
providers of outpatient physical therapy facilities are required under Subpart H of 42
C.F.R. Part 485. One of the conditions of participation is program evaluation at 42 C.F.R.
4

§ 485.729. The regulation at 42 C.F.R. § 485.729 requires that a rehabilitation agency
that provides outpatient physical therapy services complete a clinical-record review and
an annual statistical evaluation. According to the regulations, the standard for a
rehabilitation agency that offers outpatient physical therapy services is that:

An evaluation is conducted annually of statistical data such as number of
different patients treated, number of patient visits, condition on admission
and discharge, number of new patients, number of patients by diagnosis(es),
sources of referral, number and cost of units of service by treatment given,
and total staff days or work hours by discipline.

42 C.F.R. § 485.729(b).

CMS alleges that Petitioner did not meet the Annual Statistical Evaluation standard of the
Program Evaluation condition of participation during the August 7, 2006 survey. In
support of this allegation, CMS offers the declaration of the State Agency surveyor, Rick
Brummette. Surveyor Brummette completed re-visit surveys of Petitioner’s facility on
April 20, 2006 and August 7, 2006. CMS asserts that Surveyor Brummette visited the
provider, reviewed the relevant provider records, and interviewed Petitioner’s
administrator and alternate administrator. CMS Br. at 6. According to Surveyor
Brummette, Petitioner remained out of compliance with the federal requirements for
program evaluation for 2005. CMS Ex. 4 (Rick Brummette Declaration). CMS
acknowledges that Petitioner did produce various records and statistics related to the
ongoing operations of the facility. However, CMS contends that although clinical record
review and statistical analysis are important parts of the annual evaluation, “the dominant
requirement of [42 C.F.R. § 485.729(b)] is aimed at ensuring systemic evaluation of each
organization’s ‘total program.’” CMS Br. at 7-8. CMS further contends that “mere
completion of any one evaluation component is insufficient to meet the full condition of
participation.” CMS Br. at 8.

n its brief, Petitioner argues that it met both of the standards of 42 C.F.R. § 485.729 for
Program Evaluation of outpatient physical therapy agencies. Petitioner asserts that it
completed clinical record reviews and compiled its annual statistical evaluation.
Petitioner contends that these two components of the Program Evaluation condition of
participation were further buttressed by numerous components of the two standards
related to statistical analysis and subdivisions within the report. P. Br. at 1. According to
Petitioner, its noncompliance with 42 C.F.R. § 485.729 was not addressed in the April 20,
2006 survey or the State Agency’s review of Petitioner’s correction plan. P. Br. at 2.

find that Petitioner was not in compliance with 42 C.F.R. § 485.729 (Program
Evaluation). I agree with CMS that the documents that Petitioner presented as its
program evaluation do not constitute an evaluation of its total program as required by the
regulations and the Act. Petitioner does not meet the standard of Annual Statistical
Evaluation as required in 42 C.F.R. §485.729(b).

5

Petitioner submitted its annual statistical evaluation as P. Ex. 1. Petitioner’s statistical
evaluation consists of:

. A chart entitled “Patient’s Doctor 2005” that divides a list of patients by
first and last name next to one of thirteen treating physicians. P. Ex. 1, at 1,
2;

. A chart entitled “Diagnosis Statistics 2005” that lists each patient by first

and last name along with abbreviations for nine different diagnoses and the
patient’s physician. P. Ex. 1, at 3, 4;

. A monthly chart that breaks down the number of visits, the payment and the
cost per visit of the patients that were treated at the facility. P. Ex. 1, at 5;
and

. A chart entitled “PT Visits” which provides a monthly and yearly total of

the number of visits by patients to the facility. P. Ex. 1, at 6.

There is no written report accompanying these charts that interprets what these numbers
mean to the facility or anyone reviewing them. Any type of evaluation of these numbers,
statistics, and names is absent from the document as presented. Numbers, statistics, and
names alone cannot be considered as an evaluation within the meaning of 42 C.F.R.

§ 729(b). What Petitioner appears to have submitted as its annual statistical evaluation is
what can only be considered as the first step in a multi-step process. The program
evaluation regulation requires that a facility must go beyond compiling names and
numbers in its statistical evaluation and that the raw data must be interpreted and
evaluated in written form in order that appropriate utilization of the facility’s services can
be ensured and whether the facility’s policies are followed in providing services to
patients through employees or under arrangements with others can be determined. 42
C.F.R. § 485.729. Also, it appears from the documents submitted as its annual statistical
evaluation by Petitioner that the documents only included some of the suggested data;
information such as number of new patients and total staff days or work hours by
discipline were not included in Petitioner’s report. While each form of data that is listed
may not be required, these types of data are listed so that a facility’s total program can be
properly evaluated. Each of the forms of data listed in section 485.729(b) of 42 C.F.R.
would contribute to a complete and total program evaluation. Petitioner’s submitted
documents fail to meet the standard and are lacking as to what can be considered a
complete and total program evaluation.

Petitioner has not given any reasonable explanation as to why a comprehensive written
statistical evaluation was not completed. Petitioner argues that it was not aware of the
gravity of the noncompliance because the Program Evaluation Condition of Participation
was not “addressed” in the facility’s April 20, 2006 survey or in the State Agency’s
review of the correction plan. P. Br. at2. However, during Petitioner’s annual
recertification survey completed on March 15, 2006, Petitioner was cited for not meeting
the annual statistical evaluation standard. This deficiency is documented on the March
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20, 2006 Statement of Deficiencies as well as Petitioner’s plan of correction for this
deficiency. CMS Ex. 1, at 17, 18. Petitioner’s plan of correction states that:

We are currently compiling data for our annual statistical evaluation for
2005, and it will be complete within the next 2 weeks. It will be the
responsibility of the Administrator, to begin collecting data at the close of
each fiscal year, in order to complete this report by the end of each March,
in accordance with our policies. He will monitor this annually.

Id. at 17. During the April 20, 2006 re-visit survey, Petitioner was again cited for not
meeting the annual statistical evaluation standard. CMS Ex. 2, at 15. Also, during the
April 20, 2006 survey, Petitioner was cited for failing to document measures for ensuring
the completion of an annual program evaluation. CMS Ex. 2, at 14, 15. Furthermore, as
CMS argues, Petitioner has “an on-going duty to comply with the Medicare Conditions of
Participation .. .” and “this duty exists independent of the survey process.” CMS Br. at 4.

Petitioner contends that it met both the standards of 42 C.F.R. § 485.729 and attempts to
support its contention by describing how it provides a breakdown of the statistical data
and subdivides the raw data. P. Br. at 1. But it is in this description that it is apparent
that Petitioner does not demonstrate a full appreciation of the Program Evaluation
Condition of Participation. Petitioner describes this breakdown of data as being presented
in a summary numerical format. Jd. But even Petitioner acknowledges in its submission
that “the only thing missing was the results were not summarized in a statement.” Jd.
Although a written summary of the results is not the only thing missing, it is a key
component of 42 C.F.R. § 485.729. Surveyor Brummette, stated in his declaration that
“merely producing the individual data components without any evidence of overall
analysis is not sufficient to demonstrate a systemic evaluation of a provider’s total
program.” CMS Ex. 4, at 5. I find the surveyor’s opinion persuasive. A statistical
evaluation should include a written summary and analysis of the data provided
concerning a facility’s total program. Despite Petitioner’s contention that the results not
having been summarized in a statement as being a “minor omission;” I disagree. Without
these components it is much more difficult to evaluate whether a facility’s policies are
followed and whether there is an appropriate utilization of services as required in the
regulations. I infer from Petitioner’s argument that the program evaluation condition of
participation may be complied with by merely reciting in narrative from what is shown in
the statisical compilation. Such understanding is a misconception of the regulatory
requirement. A facility that does not interpret its collected data through a written
statistical evaluation falls short of the requirements in 42 C.F.R. § 485.729.

CMS has presented additional evidence that Petitioner should have known that an annual
statistical evaluation was required in order to achieve compliance with the relevant
Conditions of Participation. As part of Petitioner’s approved policies and procedures that
7

Petitioner submitted along with its hearing request is a policy entitled “Program
Evaluation” that has an effective date of 3/28/06. Part of this policy is the statement that:

In order to assure appropriate utilization of services and to determine
whether the organization’s administrative and clinical policies are followed,
a systematic evaluation of the total program will be conducted on an annual
basis by members of the Governing Body.

CMS Ex. 5, at 18.
In the procedure section of the policy statement, Petitioner’s statement sets out that:

2. Ata minimum, the review will include:
Administrative policy and procedure review
Clinical policy and procedure review
Number of referring physicians

Number of new patients & different patients
Number of discharged patients

Patient outcomes

Number of patients per diagnosis

Cost per unit of service

Number of staff days per discipline

~ TO BOO >

3. The evaluation report will include a statement of the organization’s
current standing future plans, summary and conclusions with
recommendations.

CMS Ex. 5, at 18. Petitioner’s Policies and Procedures appear to have the necessary
components that, if followed, would have satisfied the Program Evaluation conditions of
participation. According to Surveyor Brummette, he conducted telephone interviews on
August 7, 2006 with Petitioner’s Administrator and Alternative Administrator and was
told that as of that date, no report had been generated for the most recent calendar year,
2005. Petitioner had five months from when it was first cited for not completing an
annual statistical evaluation and four months from the effective date of its “Program
Evaluation” policy to come into compliance with 42 C.F.R. § 485.729 by completing an
evaluation report. It was Surveyor Brummette’s opinion that had National Rehab actually
followed its own Program Evaluation policy and completed a report that included all of
the components and analysis required by the policy, that such a report would have
probably met the condition of participation regarding Program Evaluation. /d., at 4-5.

B. Petitioner’s Medicare provider agreement may be terminated by CMS.

Pursuant to 42 C.F.R. § 489.53(a) CMS may terminate the agreement with any provider if
CMS finds that the provider no longer meets the appropriate conditions of participation.
In this case, Program Evaluation is a condition of participation for outpatient physical
therapy agencies. One of the two standards for the program evaluation condition of
participation is that the provider conduct an annual statistical evaluation. Petitioner did
not provide the State Agency with a credible annual statistical evaluation, thus, it was not
in compliance with the condition of participation for outpatient physical therapy agencies.
Therefore, CMS is authorized to terminate Petitioner’s provider agreement.

V. Conclusion

Based on the documentary evidence, the arguments of the parties, and the applicable law
and regulations, I find that Petitioner was not in substantial compliance with the
conditions of participation for rehabilitation agencies that provide outpatient physical
therapy services and that CMS is authorized to terminate Petitioner’s provider agreement.

/s/
José A. Anglada
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
)
Britthaven of New Bern )

(CCN: 34-5211), ) Date: September 2, 2008
)
Petitioner, )
)

-Vv.- ) Docket No. C-08-70
) Decision No. CR1837
Centers for Medicare & Medicaid )
Services. )
)
DECISION

I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to
impose remedies against Petitioner, Britthaven of New Bern, a skilled nursing facility
which participates in the Medicare program and which does business in the State of North
Carolina. All of these remedies address failures by Petitioner to comply substantially
with Medicare participation requirements. The remedies | sustain are civil money
penalties of:

+ $250 per day for each day of a period beginning on July 14 and running through
July 15, 2007;

+ $4050 per day for each day of a period beginning on July 16 and running through
July 18, 2007; and

+ $200 per day for each day of a period beginning on July 19 and running through
August 30, 2007.
I. Background

Petitioner’s participation in Medicare as a skilled nursing facility is governed by sections
1819 and 1866 of the Social Security Act and by regulations at 42 C.F.R. Parts 483 and
488. Its right to a hearing in this case is governed by regulations at 42 C.F.R. Part 498.

Petitioner was surveyed for compliance with Medicare participation requirements in
surveys that ended on July 25 (July survey) and on August 28 (August survey) 2007. The
surveyors found noncompliance at each of these surveys. These noncompliance findings
included two findings, made at the July survey, that Petitioner’s noncompliance was so
egregious as to pose immediate jeopardy for its residents. Regulations define “immediate
jeopardy” as being noncompliance that causes or has the likelihood of causing serious
injury, harm, impairment, or death to residents of a facility. 42 C.F.R. § 488.301. CMS
accepted the surveyors’ findings and determined to impose the remedies that I describe in
this decision’s opening paragraph.

Petitioner requested a hearing and the case was assigned to me for a hearing and a
decision. The parties completed pre-hearing exchanges of proposed exhibits and briefs. I
scheduled the case for an in-person hearing. CMS then moved for summary disposition
and Petitioner opposed the motion. I conferred with the parties and they agreed that the
case could be decided based on their written submissions. | therefore cancelled the in-
person hearing and provided the parties with the opportunity to submit final briefs. Each
party submitted a final brief. I then directed CMS to submit additional clarifying
comments to address some ambiguities that I identified in its brief. CMS complied and
Petitioner responded to that.'

CMS submitted proposed exhibits which it identified as CMS Ex. 1 - CMS Ex. 52.
Petitioner submitted proposed exhibits which it identified as P. Ex. 1 - P. Ex. 23. I
receive all of these exhibits into evidence.”

' In its several briefs, CMS continues to advocate at times that I issue summary

disposition in its favor. But, although some of the facts of this case are undisputed,
summary disposition is not at issue here. Rather, the parties have agreed to have their
cases tried based on their written submissions which include the written direct testimony
of several witnesses.

2

* CMS submitted two amended exhibit lists and additional exhibits after it had
completed its pre-hearing exchange. With its first amended exhibit list, CMS added four
new exhibits, CMS Ex. 53 - CMS Ex. 56. With its second amended exhibit list, CMS
added two additional new exhibits, CMS Ex. 57 and CMS Ex. 58. Iam excluding CMS

3
II. Issues, findings of fact and conclusions of law
A. Issues
The issues in this case are whether:

1. Petitioner failed to comply substantially with Medicare participation
requirements at the July and August surveys.

2. CMS’s determination that Petitioner’s noncompliance at the July survey
constituted immediate jeopardy level noncompliance is clearly erroneous.

3. Petitioner’s non-immediate jeopardy level compliance persisted through
August 30, 2007.

4. CMS’s remedy determinations are reasonable.
B. Findings of fact and conclusions of law

I make findings of fact and conclusions of law (Findings) to support my decision. I set
forth each Finding below as a separate heading.

1. Petitioner was noncompliant with Medicare participation requirements
as of the July survey.

Here I address the two immediate jeopardy level findings of noncompliance that were
made at the July survey. There was a third finding of noncompliance, an alleged failure
by Petitioner to comply with the requirements of 42 C.F.R. § 483.12(a)(7), about which
neither party has provided argument, and which I do not address.

Ex. 53 - CMS Ex. 58 because CMS failed to file them timely, and failed to make a
showing of good cause for not filing the exhibits timely. My initial pre-hearing order in
this case made it plain to the parties that I expected that they would file a// of their
proposed exhibits with their initial exchanges and that I would allow a party to
supplement its exchange only with a showing of good cause and an absence of prejudice
to the opposing party. CMS has not made either showing here.
4

a. Petitioner failed to comply substantially with the requirements
of 42 C.F.R. § 483.13 (a).

The regulation which is at issue here states that a resident of a skilled nursing facility has
a right to be free from any physical or chemical restraints imposed by a facility for
purposes of discipline or convenience and not required to treat the resident’s medical
symptoms. CMS alleges that Petitioner restrained four of its residents inappropriately.
These residents are identified in the July survey report as Residents #s 1, 2, 3, and 4.
CMS Ex. 16, at 6.

The undisputed facts establish that Petitioner imposed involuntary restraints on all of
these residents as a measure to prevent them from falling. Each of these residents had
medical and or psychological problems that placed him or her at great risk for falls. Some
of them had a history of falling. The interventions that Petitioner adopted to address this
problem included tying the residents to their wheelchairs with non self-releasing seatbelts.
CMS argues that Petitioner’s use of involuntary restraints was wrong, both as a matter of
law and as a matter of sound nursing practice. It contends that involuntary restraints are
never appropriate tools for dealing with fall risks. In fact, according to CMS, the use of
such devices actually increases the likelihood that residents will sustain injurious falls.

I find CMS’s arguments to be well-supported by the evidence. There simply was no
legitimate justification for Petitioner’s use of involuntary restraints as a protective
measure.

These residents shared common characteristics and the care that Petitioner provided to
them had similar features. Each of these residents was an elderly individual with
debilitating physical and/or mental impairments. Resident # 1 was 73 years old and
suffered from congestive heart failure, a below-the-knee amputation of his right leg,
Parkinson’s disease, and depression. CMS Ex. 16, at 7; CMS Ex. 18, at 1-4; CMS Ex. 19,
at 2. Resident # 2 was aged 71 years, and had diagnoses of late stage Parkinson’s disease,
diabetes, stroke, renal insufficiency, and ambulatory dysfunction. CMS Ex. 16, at 20;
CMS Ex. 21, at 2. Resident # 3 was 78 years old and had suffered a stroke, mental status
change, and depression. CMS Ex. 16, at 22; CMS Ex. 22, at 7. Resident # 4 was 92
years old and had diagnoses including dementia, anxiety, and depression. CMS Ex. 16, at
23.

Each of the four residents was prone to sustaining falls. Resident # 1 experienced several
falls during the approximately three weeks that he resided in Petitioner’s facility. CMS
Ex. 18, at 7, 12, 16, 17, 26. Resident # 2 was identified by Petitioner’s staff as being at
risk for falling. CMS Ex. 21, at 11. Resident # 3 had been identified by the staff as being
a fall risk and, in fact, the resident sustained a fall from her wheelchair on March 26,
5

2007. CMS Ex. 22, at 7; CMS Ex. 23, at 9. Resident # 4 was identified as having an
unsteady gait which put her at risk for sustaining falls. CMS Ex. 24, at 3.

The evidence establishes further that Petitioner’s staff attempted various interventions
with each of these residents in order to protect them against falling. However, the staff
decided that each required an involuntary physical restraint. Petitioner obtained a
physician’s order for involuntary physical restraints for each of the four residents. CMS
Ex. 18, at 10-11; CMS Ex. 21, at 54, 56; CMS Ex. 23, at 1, 9; P. Ex. 18, at 7-8.
Petitioner’s staff tied all of these residents to their wheelchairs with non self-releasing
seat belts. CMS Ex. 18, at 24-25; CMS Ex. 21, at 63; CMS Ex. 23, at 9; CMS Ex. 24, at
1-2.

The use of involuntary restraints by skilled nursing facilities has long been a controversial
issue. More than 20 years ago, experts reached a consensus that the overuse of physical
restraints and the harm caused by their use constituted a major problem in such facilities.
CMS Ex. 50, at 1-23 I take notice that the Secretary’s principal purpose in adopting 42
C.F.R. § 483.13(a) was to assure that facilities used restraints only in circumstances
where residents’ medical conditions made their use absolutely necessary. See id.

That intent is restated in a policy memorandum, issued on June 22, 2007, from the
director of CMS’s survey and certification group to State survey agency directors. CMS
Ex. 35. The purpose of the memorandum is to describe the circumstances where use of
physical restraints may be appropriate. The memorandum reiterates the Secretary’s
policy that restraints may be used by a facility under only the most limited circumstances.
It states that a resident may not be restrained unless he or she has a specific medical
symptom that cannot be addressed by another, less restrictive intervention. Jd. at 2.
Furthermore, the restraint must be required to treat a resident’s symptom, to protect his or
her safety, and help him or her attain or maintain his or her highest level of physical or
psychological well-being.

> The clinical literature about restraints, some of which I discuss in this decision,
focuses on the risks that these devices pose for residents as opposed to the possible
benefits that they may produce. The dry tone of these analyses fails at times to capture
the essential nature of a restraint. When a nursing facility resident is restrained
involuntarily that individual is subjected to limitations on his or her freedom of movement
which exceed those which are imposed by our prisons on their inmates.
6

The memorandum additionally makes it clear that a heavy burden lies on a facility that
seeks to justify using a restraint. A physician’s order does not justify a facility using a
restraint where that measure is not supported by the resident’s entire medical record.
CMS Ex. 35, at 2.

Most pertinent to this case is that the memorandum proscribes using restraints as a
mechanism for protecting residents against falling:

Falls do not constitute self-injurious behavior or a medical symptom that
warrants the use of a physical restraint. Although restraints have been
traditionally used as a falls prevention approach, they have major, serious
drawbacks and can contribute to serious injuries. There is no evidence that
the use of physical restraints . . . will prevent or reduce falls. Additionally,
falls that occur while a person is physically restrained often result in more
severe injuries.

Id. at 3 (emphasis added).

Thus, and as a matter of policy, involuntary restraints may not be used as a falls
protection device. The risks to residents of physical and psychological injury resulting
from the use of restraints outweigh any possible benefits that may be obtained from their
use.

This policy is supported by the professional literature. The policy memorandum rests on
journal articles which find that restraints do not protect residents against sustaining falls.
CMS Ex. 35, at 3 n.1. The weight of professional opinion is that restraints do not reduce
the likelihood that residents will sustain falls but, rather, increase that likelihood. CMS
Ex. 52, at 5

The fact that Petitioner, by its own admission, used involuntary restraints as a falls
prevention measure establishes Petitioner not to be compliant with regulatory policy.
Petitioner’s actions were improper as a matter of law. They contravened professionally
recognized standards of care. And, they were also ineffective.

The ineffectiveness of Petitioner’s use of restraints is demonstrated by the history at
Petitioner’s facility of Resident # 1, who is one of the four residents whose care is at
issue. This resident was at a very high risk for falls while at Petitioner’s facility. He was
at times agitated, he manifested irrational behavior, and he fell often from his wheelchair.
Petitioner’s solutions to the problems posed by the resident’s propensity to fall included

7

tying him to his wheelchair with a non self-releasing restraint. The consequences of
restraining the resident were not beneficial. The resident’s propensity for sustaining falls
did not diminish as a consequence of being restrained. His level of agitation increased.
And, in fact he fell at least twice after Petitioner’s staff restrained him.

On July 10, 2007, Petitioner’s staff obtained an order from a physician for a non self-
releasing seatbelt to be applied to Resident # 1. CMS Ex. 18, at 10. The evidence
establishes that the resident became increasingly agitated after being restrained and he
continued to fall. On July 14, 2007, the resident was observed to be very agitated. He
loosened his seatbelt and attempted to pull it over his head. CMS Ex. 18, at 14. He
remained agitated on the following day. Jd. at 15. On July 16, 2007, at about 5:30 p.m.,
the resident was found to be lying in front of his wheelchair on the floor of Petitioner’s
dining room. P. Ex. 11, at 89. The stitching on his seatbelt had broken. The resident was
put back in his wheelchair and tied in with a new non-releasing belt. At about 9:00 p.m.
on that same evening, Petitioner’s staff found the resident lying on the floor on his right
side, having tipped over the wheelchair in an evident attempt to free himself from his
restraint. /d. Petitioner’s staff restrained the resident in a “rock and go” wheelchair in an
effort to prevent the resident from tipping his chair over. On July 17, 2007, the staff
noted that the resident’s agitation had increased. He was observed to be grasping at the
facility’s walls and on wall safety rails and jerking on them. Jd. The staff administered
Ativan, a tranquilizer, to the resident, with little effect. Jd. On the evening of July 17, the
resident was found sitting on the floor of Petitioner’s TV room. CMS Ex. 18, at 17.

The resident was briefly hospitalized on July 17, 2007. He returned to Petitioner’s
facility on July 18, at which time he was again restrained and provided with continuous
monitoring. However, on July 22, 2007, the resident became extremely agitated and
attempted to scoot out of his restraint and the “rock and go” wheelchair. CMS Ex. 18, at
21.

I have considered the arguments that Petitioner makes in support of its restraining the four
residents whose care is at issue here. I find these arguments to be unpersuasive.

Petitioner argues that “the crux of the dispute” between it and CMS is that Petitioner
believes that the circumstances pursuant to which a skilled nursing facility may use
involuntary restraints includes protection of residents who are at high risk for sustaining
falls. Petitioner’s final brief at 6. According to Petitioner skilled nursing facilities have
traditionally and appropriately used restraints to protect residents against sustaining falls
and its use of these restraints in the cases of Residents #s 1, 2, 3, and 4 is consistent with
such allegedly traditional use. In its eyes, the policy memorandum that I discuss above
represents a departure from tradition and from professionally recognized standards of
care. Petitioner adds that, even if the memorandum now constitutes the Secretary’s
binding policy precluding use of restraints for falls protection, it should not be held
accountable for violating that policy inasmuch as this allegedly new policy was
effectuated only weeks before the July survey took place.

I disagree with Petitioner’s assertions that the policy prohibiting involuntary restraints as
a falls prevention measure states a new policy or is a departure from professionally
recognized standards of care governing the use of restraints. The memorandum captures
the weight of professional opinion that has accumulated over decades of experience. As I
discuss above, the policy memorandum is grounded on numerous journal articles which
hold that using restraints as a falls protection measure is never in the interest of residents.
CMS Ex. 35, at3 nl.

Additional long-standing professional opinion not cited in the memorandum supports the
policy prohibiting use of involuntary restraints as a falls prevention measure. In 1994,
thirteen years prior to the July survey, two physicians who studied the issue of restraints
use in nursing homes stated:

The most common and apparently misguided use of restraints is to prevent
falls. The risk factors for being restrained and for falling substantially
overlap. Falls are very common in restrained patients. There is evidence
that restraints do not decrease fall-related injuries.

Steven H. Miles, M.D., and Roberta Meyers, M.D., Untying the Elderly, 1989 to 1993
Update, CLINICS IN GERIATRIC MEDICINE, Vol. 10, No. 3, August 1994, at 513 (emphasis
added) (citations omitted). Dr. Miles, whose expert testimony was provided by CMS,
testified that:

[S]cientific literature has long dispelled the notion that restraints are
effective in preventing falls. Not only are restraints not effective in
preventing falls but studies have shown that restraints can increase the risk
of serious injuries from falling.

CMS Ex. 52, at 5.

Petitioner argues that CMS’s ban on the use of restraints to prevent falls depends on a
rationale which is inapplicable to a specific subgroup of residents. According to
Petitioner these residents comprise precisely the type of residents whose care is at issue
here. They are those residents who are confused, elderly, and non-ambulatory or who are
unable to transfer or ambulate safely without staff assistance, and who lack the judgment
to seek necessary assistance. Petitioner’s final brief at 10. Petitioner contends that while
others may not benefit from the use of restraints the residents who are part of this
9

subgroup do benefit from such measures. Consequently, according to Petitioner, its
restraining the four residents whose care is at issue, all asserted to be members of the
subgroup that benefits from restraints, was consistent with professionally recognized
standards of care.

As support for this contention Petitioner cites a single journal article, Capezuti et al.,
Physical Restraint Use and Falls in Nursing Home Residents, 44 JOURNAL OF THE
AMERICAN GERIATRIC SOCIETY, 627-633, 631 (1996). Petitioner relies on the following
statement in that article:

Restraint use with nonambulatory residents, both confused and
nonconfused, was associated with a lower risk of falls and injuries.

Id. Petitioner did not supply this article nor did it explain the methodology used for its
purported conclusion. I do not find the single citation relied on by Petitioner to be
persuasive in the absence of any explanation of the article’s contents and methodology.
At most it comprises an outlier analysis that contradicts a large body of literature which
states a different conclusion. Petitioner did not buttress this article with any empirical
evidence or expert testimony which refutes the mass of expert opinion provided by CMS
or which shows that the policy prohibiting use of restraints for falls protection is
unsupported.

I take notice also that the article’s principal author co-authored another article in 1998
which states a conclusion that is entirely consistent with mainstream thought about the
benefits of restraints as a falls prevention measure:

Based on the multiple logistic regression analysis, there was no indication
of increased risk of falls or injuries with restraint removal. Moreover,
restraint removal significantly decreased the chance of minor injuries due to
falls ... CONCLUSIONS: Physical restraint removal does not lead to
increases in falls or subsequent fall-related injury in older nursing home
residents.

Capezuti et. al, The Relationship Between Physical Restraint Removal and Falls and
Injuries Among Nursing Home Residents, 53 JOURNALS OF GERONTOLOGY SERIES A:
BIOLOGICAL SCIENCES AND MEDICAL SCIENCES, Issue 1, at M47-M52 (1998).

But, even assuming that the regulation governing the use of restraints hypothetically
permits these devices to be used by a facility to protect a resident or residents against
falling, I do not find that Petitioner established that restraining its residents was a
10

necessary element of their care. Petitioner has not made a credible showing that any of
the residents whose care is at issue actually benefitted by being restrained.

Petitioner’s case boils down to contending that it had tried every other intervention its
staff could think of to protect the residents whose care is at issue without obtaining an
effective level of protection. Consequently, according to Petitioner, it restrained these
residents as an intervention of last resort. I find that to be an inadequate justification for
the use of restraints. Restraining residents because other interventions have not worked to
protect them is not justified given the great mass of professional opinion and empirical
evidence to the effect that restraining falls prone residents actually increases their risk of
falling.

While I have no doubt that these residents’ propensities for falling were caused by
underlying medical conditions and that their instability and lack of judgment merited
aggressive care by Petitioner and its staff, I do not find that Petitioner established that
restraining the residents was an appropriate intervention.’ Petitioner has simply not
adduced evidence showing why, as a matter of logic and sound nursing care, restraining
these residents would have helped them.

Indeed, the weight of the evidence in this case establishes that, at least insofar as Resident
# 1 is concerned, the resident did not benefit from the use of restraints. Resident # 1
became more agitated after he was restrained. He fought against his restraints and he fell
at least twice after he was restrained. Notwithstanding, Petitioner’s staff made no effort
to reassess their determination to restrain him, did not ask the resident’s physician to
reconsider his order to restrain the resident, and did not contemplate removing the
restraints.’ That evidence is sufficient, standing alone, to sustain a finding of

* CMS argues at length that none of the residents manifested “symptoms” that
would have justified restraining them. It is unnecessary that I decide this argument
because it is clear that Petitioner did not establish that restraining the residents comprised
appropriate care to treat the residents’ instability and/or poor judgment.

> Petitioner asserts that putting the resident in a “rock and go” wheelchair after his
second post-involuntary restraint fall on July 16, 2007, was an appropriate intervention in
response to the resident’s problems. Petitioner’s pre-hearing brief at 33. I disagree. The
“rock and go” chair may have been somewhat more stable than the chair previously used
by the resident. But, it did not ameliorate the resident’s increased agitation nor did it
eliminate the risk that the resident might fall. In fact, the resident came out of the chair
on July 17, 2007. CMS Ex. 18, at 17.
11

noncompliance even if, as a matter of law, the use of restraints as a falls prevention
technique was not prohibited.

Petitioner introduced the testimony of the physician who ordered that Residents #s 2, 3,
and 4 be restrained as support for its contention that it acted reasonably to restrain these
residents. P. Ex. 18.° With respect to Resident # 2, the physician avers that the use of an
involuntary restraint was appropriate in order to protect the resident due to the failure of
other protective measures attempted by Petitioner and due also to the resident’s
progressively deteriorating condition. Jd. at 3-4. He contends that it was appropriate to
restrain Residents #s 3 and 4 involuntarily, essentially for the same reasons. Jd. at 4-9.

I do not find this testimony to be persuasive. The physician does not explain how
restraining any of these residents against their will would have provided any of them with
enhanced protection against falls. Use of restraints is not justified by saying that the
residents were at great risk for falling and that their medical conditions were
deteriorating. Assuming the accuracy of the physician’s assessment of these residents’
physical and mental conditions, that does not justify the use of involuntary restraints in
the absence of clear evidence that the residents would benefit from being restrained.

Finally, I am not persuaded that Petitioner established that there were no alternatives to
restraining the four residents whose care I have discussed. Each of these residents shared
a common characteristic. Their many physical and mental impairments rendered them
incapable of standing and walking safely without close supervision. But, these common
problems suggest a common solution, enhanced supervision of the residents. Petitioner
has not shown that these residents would not have benefitted simply by being watched
more closely by facility staff in lieu of being tied to their wheelchairs.

The regulation forbids a facility from restraining residents for purposes of its own
convenience and that, I find, is the true crux of this case. When challenged with problems
that would have been financially daunting to solve or which required possibly more
intensive dedication of staff resources, Petitioner opted instead to restrain the residents.
Petitioner’s administrator comes close to admitting that, in fact, its use of restraints was,

® Petitioner did not provide a physician’s testimony explaining the reasons for
restraining Resident # | against his will.
12

at bottom, premised on reasons of convenience rather than as treatment for residents’
conditions:

As the facility Administrator at Britthaven of New Bern, I am of the opinion
that it would be operationally and financially unfeasible to provide 24 hour
one to one monitoring for all residents who are at risk for falls.

P. Ex. 19, at 2.

Petitioner argues that it would have had to hire as many as eight additional employees in
order to have provided the residents with the intensive one-on-one supervision that might
have obviated the need for restraints. Which is to say that Petitioner asserts that it might
have been quite costly for it to give these residents care that effectively protected them. I
am not persuaded that any of these residents needed “24 hour one to one monitoring” in
order to be kept safe (for example, Petitioner did not tie the residents to their beds when
they were out of their wheelchairs and the residents evidently slept without continuous
observation) and I find no evidentiary support for Petitioner’s assertion that it would
require eight additional employees to protect the residents adequately. But, even ifa
significant augmentation of staff resources would have been necessary to safeguard these
residents from falling, that does not excuse Petitioner from failing to provide such care.
Providing necessary care was an obligation which it assumed when it applied to
participate in Medicare and when it accepted the four residents.

b. Petitioner failed to comply substantially with the requirements
of 42 C.F.R. § 483.25(h)(1).

The regulation which is at issue here states that a facility must ensure that its residents’
environment remain as free of accident hazards as is possible. The regulation imposes on
a facility the duty of accounting for all hazards that it knows or should know pose a threat
for resident safety and well-being and it requires the facility to take every reasonable
measure to eliminate such hazards.

CMS’s allegations of noncompliance derive from the care that Petitioner provided to
Resident # 1, the resident whose care I discussed in detail at subpart a. of this Finding. In
essence, CMS alleges that restraining the resident constituted a hazard to his well-being
because it created the likelihood that the resident would fall. The gravamen of CMS’s
case against Petitioner is that, once Petitioner restrained Resident # 1, it had the obligation
13

to assure the resident’s safety, either by eliminating the restraint or by providing the
resident with intensive supervision at all times. CMS Ex. 16, at 24-48.’

I find CMS’s argument to be well-founded. As I discuss above, the accepted professional
literature holds that restraining residents increases the likelihood of falls. Petitioner
should have known that the resident was at an increased risk for falling after he was
restrained against his will.

The increased risk to Resident # | was not only apparent from the accepted professional
literature, of which Petitioner’s nursing staff should have been aware, but it was made
evident by the resident’s behavior and the consequences of that behavior after he was
restrained. The record unequivocally establishes that the resident strongly resisted being
restrained and struggled more or less continuously against his restraint after it was applied
by Petitioner’s staff. In the wake of being restrained, the resident suffered two falls on
July 16, 2007.* Petitioner argues that the first of these falls is attributable solely to a
defective restraint, contending that the restraint broke, thus allowing the resident to
become unstable and to fall. However, there is no evidence to prove that there was a
defect in the restraint and it is equally possible that the restraint broke simply as a
consequence of the resident’s struggles against it. And, even if the restraint was
defective, I infer from the evidence that the resident would not have fallen but for his
struggles after being restrained.

In any event, whether the resident’s first fall was as a consequence of a defective restraint
or the consequence of his vigorous resistance to being restrained, that fall coupled with
the resident’s heightened agitation and efforts to escape put Petitioner’s staff on notice
that restraining the resident enhanced the resident’s risk of falling. The staff knew that
the resident was resisting his restraint and that his struggling increased the likelihood of a
fall. The second fall that occurred on July 16 was a foreseeable consequence of the
resident’s continued struggles to free himself from his restraints.

Petitioner argues that, whatever hazards may have contributed to the resident’s July 16
falls, they were eliminated by placing the resident in a “rock and go” wheelchair. That
intervention, according to Petitioner, gave the resident enhanced stability and eliminated

7 In stating this argument CMS does not concede that restraining the resident was
appropriate.

® T cite to the exhibits which describe these events above, at subpart a. of this
Finding.
14

the likelihood that he would tip the chair over. I do not find this argument to be
persuasive.

Placing the resident in the “rock and go” chair did not do anything to ameliorate the
resident’s increased agitation. He continued to struggle afterwards, to the extent that, on
numerous subsequent occasions, the staff administered Ativan to the resident in an
attempt to calm him. P. Ex. 11, at 89-92. Nor did placing the resident in the “rock and
go” chair eliminate the likelihood that the resident would fall as a consequence of his
agitation and his struggling. On July 17, 2007, after the resident had been placed in the
“rock and go” wheelchair he was found to be sitting on the floor of Petitioner’s TV room,
having come out of the chair as a result of his struggling against his restraints.

2. Petitioner remained noncompliant with a Medicare participation
requirement as of the August survey.

CMS’s allegations of continuing noncompliance by Petitioner as of the August survey
again are based on the provisions of 42 C.F.R. § 483.25(h). CMS Ex. 26, at 1-4. CMS
contends that Petitioner failed to provide adequate supervision to a resident who is
identified as Resident # 1 in the report of the August survey.”

The undisputed facts establish that the resident was an individual with a history of falls
who was unsteady even when she was seated. CMS Ex. 26, at 1. The resident had been
given a seat belt known as a “lap buddy” to wear while she was in her wheelchair as a
supportive device.'° On July 14, 2007, Petitioner’s hairdresser found the resident to be
lying on the floor of the facility’s dining room. The resident was transferred to a hospital
for assessment of complaints of leg pain and was diagnosed to be suffering from a left hip
fracture. Id. at 2.

CMS asserts — and I agree — that the prima facie evidence shows that Petitioner was
remiss in supervising Resident # 1. This resident was an individual who was known to be

° In its briefs, CMS refers to this resident as “Resident # 5” ostensibly in order to
avoid confusing this resident with the different resident who is identified as Resident # 1
in the report of the July survey and whose care I have discussed in detail in Finding 1. I
find that there is no need to change the identification of this resident from that which is
used in the August survey report and, so, I refer to the resident as “Resident # 1”
throughout this Finding.

'° CMS does not allege, nor do I find, that the seatbelt given to this resident was an
involuntary restraint.
15

unstable and who was at a risk for falling even when seated in a wheelchair.
Consequently, the resident needed to be supervised closely. Petitioner failed to provide
this resident with the requisite close supervision on July 14, 2007 and, consequently, she
fell. The evidence shows that Petitioner’s staff was not really aware of the resident’s
whereabouts just prior to her sustaining her fall. CMS Ex. 26, at 3; CMS Ex. 27, at 11.
For example, Petitioner’s hairdresser averred that, prior to the resident’s fall, she had
provided services to the resident and returned her to her room. CMS Ex. 26, at 3; CMS
Ex. 27, at 11; P. Ex. 23, at 1-2. But, somehow, and inexplicably unobserved, the resident
traveled to another part of Petitioner’s facility where she fell.

There is also evidence to show that someone on Petitioner’s staff improperly positioned
Resident # | in her wheelchair prior to the resident sustaining her fall. The resident had
been given a tilt wheelchair that was designed to minimize the possibility that the resident
might lean forward and fall out of the chair. CMS Ex. 26, at 2. However, at the time of
the fall someone had left the chair back in a vertical position. Jd.

Thus, the evidence offered by CMS strongly supports a conclusion that Resident # 1 was
inadequately supervised by Petitioner’s staff. The resident had a history of falls and was
known to be unstable even while in her wheelchair. Yet, on July 14, 2007 the resident
was left unsupervised with the chair improperly positioned long enough so that the
resident fell and was injured.

Petitioner’s response to this evidence is to assert that the accident occurring to Resident

# 1 was the first and only
allegedly isolated event s
Moreover, according to P.
training to its staff.

Iam not persuaded by thi
unrebutted evidence that

accident sustained by the
accident comes as a surpr

such incident involving the resident. It contends that this
ould not be viewed as evidence of overall deficient care.
etitioner, it promptly addressed the situation by providing

s argument that Petitioner was compliant. There is clear and
Petitioner’s staff was remiss in supervising Resident #1. The
resident may have been unanticipated in the sense that every
ise when it occurs. But, staff had every reason to know that

failing to closely supervise Resident #1 and failing to assure that she was properly
positioned in her wheelchair put her at great risk for an injury-producing accident.

3. CMS’s determinations of immediate jeopardy are not clearly
erroneous.

The burden falls on Petitioner to prove that a finding by CMS of an immediate jeopardy
level deficiency is clearly erroneous. CMS’s findings of immediate jeopardy attach to the
two deficiencies identified at the July survey which I address at Finding | of this decision.
16

There is ample evidence in the record to show that there was a likelihood that these
deficiencies would cause residents to suffer serious injury, harm, impairment or death.
All four of the residents who were restrained against their will were exposed to the
likelihood of grave physical and/or psychological harm. Indeed, the reaction of one of
them, Resident # 1, to being restrained is graphic evidence of how the imposition of
restraints can cause both agitation and falls. That conclusion is buttressed by the
professional literature and opinion evidence offered by CMS showing that restraints as a
falls reduction technique actually increase the likelihood that residents will suffer serious
falls.

Petitioner has not offered rebuttal evidence which proves CMS’s findings of immediate
jeopardy to be clearly erroneous. Indeed, Petitioner has not offered argument or
identified evidence which it purports to show that its deficiencies — assuming them to be
established — were at a level of scope and severity that is less than immediate jeopardy.

4. Petitioner’s non-immediate jeopardy level noncompliance persisted
through August 30, 2007.

Once noncompliance is established the burden falls on the facility to prove that it has
corrected its deficiencies. In this case, CMS determined that Petitioner’s non-immediate
jeopardy level noncompliance with the requirements of 42 C.F.R. § 483.25(h), identified
at the August survey as commencing on July 14, 2007 with Resident # 1’s fall, persisted
through August 30, 2007.'' Petitioner has not offered persuasive proof to establish that it
attained compliance at an earlier date.

Petitioner asserts that it addressed the circumstances surrounding the fall of Resident # 1
by providing its staff with in-service training on proper positioning of residents.
Petitioner’s pre-hearing brief at 36. Petitioner contends also that it gave one-on-one
inservice training to its hairdresser on July 16, 2007.

Petitioner’s records show that it did not complete its staff in-service training relative to
the deficiency identified at the August survey prior to at least August 31, 2007. That is
the date on which Petitioner’s staff received training on monitoring residents for safety.
CMS Ex. 32, at 5. And, indeed, the plan of correction submitted by Petitioner addressing
the August survey deficiency does not represent that training relating to that deficiency
was completed before October 15, 2007. This evidence satisfies me that Petitioner did

'' T refer here to the resident who was identified as Resident # | at the August
survey and not to the resident who was identified as Resident # | at the July survey.
17

not prove that it attained compliance prior to August 30, 2007, the correction date
determined by CMS.

5. CMS’s remedy determinations are reasonable.

CMS determined to impose civil money penalties of $4050 per day for July 16-18, 2007
to remedy Petitioner’s immediate jeopardy level noncompliance. It determined to impose
penalties of $250 per day to remedy Petitioner’s non-immediate jeopardy level
noncompliance on July 14-15, 2007 and $200 per day for each day from July 19 through
August 30, 2007, also to remedy Petitioner’s non-immediate jeopardy level deficiencies.
I find these determinations to be reasonable.

a. Civil money penalties of $4050 per day are reasonable to
remedy Petitioner’s immediate jeopardy level noncompliance.

Per-diem civil money penalties imposed to remedy immediate jeopardy level
noncompliance must fall within a range of from $3050 to $10,000 per day. 42 C.F.R.

§ 488.438(a)(1)(i). There are regulatory criteria for deciding what amount within this
range may be a reasonable remedy for an immediate jeopardy level deficiency. These
criteria include: the seriousness of a facility’s noncompliance; its compliance history; its
culpability; and its financial condition. 42 C.F.R. §§ 488.438(f)(1) - (4); 488.404
(incorporated by reference into 42 C.F.R. § 488.438(f)(3)).

The immediate jeopardy level civil money penalty amount that CMS determined to
impose in this case is extremely modest, being at the bottom end of the range of penalties
that may be imposed to remedy immediate jeopardy level noncompliance. | find that, in
this case, a daily penalty amount of $4050 is justified by the seriousness of the
noncompliance. Petitioner has offered no evidence to prove that it lacks the financial
wherewithal to pay penalties in this daily amount.

As I discuss above, at Finding 3, Petitioner’s noncompliance was extremely serious. It
put residents who were restrained involuntarily at great risk for severe physical and
psychological harm. Petitioner restrained these residents for reasons of convenience and
not as a medically justified form of treatment. I find that penalties of $4050 per day are
amply justified in light of that.

Petitioner argues that, if it is liable for an immediate jeopardy level deficiency, the
penalty should be assessed at $3050, and not $4050, per day. Petitioner asserts that it is
the victim of a new and allegedly non-traditional interpretation of the regulation
governing restraints and that it should not be penalized heavily for following what it
contends was a traditional interpretation of the regulation. I do not accept this
18

characterization. As I discuss above, at Finding 1, the consensus in the nursing
profession for many years has been that restraints should not be used as a falls prevention
measure. CMS’s policy as to restraints is not new but, rather, it is simply a restatement
of that consensus. Moreover, it is apparent that Petitioner’s primary reason for
restraining these residents was not so much to protect them as it was to save itself the
expense associated with providing them with a greater degree of supervision and security.

b. Penalties of $250 and $200 per day are reasonable to remedy
Petitioner’s non-immediate jeopardy noncompliance.

The permissible range of non-immediate jeopardy level civil money penalties is from $50
to $3000 per day. 42 C.F.R. § 488.438(a)(1)(ii). The same regulatory criteria for
determining what is reasonable within this range apply here as apply to immediate
jeopardy level penalties. 42 C.F.R. §§ 488.438(f)(1) - (4); 488.404 (incorporated by
reference into 42 C.F.R. § 488.438(f)(3)).

The non-immediate jeopardy level penalties that CMS determined to impose are
extremely modest and lie at the low end of the permissible range of non-immediate
jeopardy level civil money penalties. They comprise significantly less than ten percent of
the maximum non-immediate jeopardy level penalty amount.

I find that they are strongly supported by the seriousness of Petitioner’s non-immediate
jeopardy level deficiency. CMS determined — and the evidence supports this
determination — that Resident # 1 sustained serious injuries as a consequence of
Petitioner’s failure to protect her adequately against accident hazards.'? In light of that a
minimal level daily civil money penalty, either of $250 or $200 per day, is certainly
appropriate.

/s/
Steven T. Kessel
Administrative Law Judge

° Here I refer to the Resident # 1 who is identified in the report of the August
survey.