Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
)
Rensselaer Care Center, ) Date: May 4, 2009

(CCN: 15-5287), )
)
Petitioner, )
)

-V.- ) Docket No. C-07-165

) Decision No. CR1944
Centers for Medicare & Medicaid )
Services. )
)

DECISION

Petitioner, Rensselaer Care Center, violated 42 C.F.R. § 483.25(h)(2) and was not in
substantial compliance with program participation requirements from October 17, 2006
through December 14, 2006. A $200 per day civil money penalty (CMP) for the period
October 17, 2006 through December 14, 2006, is reasonable.

I. Background

Petitioner is a long-term care facility, located in Rensselaer, Indiana. Petitioner is
authorized to participate in Medicare as a skilled nursing facility (SNF) and in the Indiana
Medicaid program as a nursing facility (NF). On October 17, 2006, the Indiana State
Department of Health (the state agency) completed a complaint survey of Petitioner and
alleged in a Statement of Deficiencies (SOD) dated October 17, 2006, that Petitioner
violated 42 C.F.R. § 483.25(h)(2). The state agency notified Petitioner by letter dated
October 25, 2006, that a mandatory denial of payment for new admissions (DPNA)
would be imposed effective January 17, 2007, and that it was recommending that the
Centers for Medicare and Medicaid Services (CMS) impose a CMP of $400 per day
effective October 17, 2006. The state agency completed a revisit survey of Petitioner on
December 15, 2006, and alleged additional deficiencies in a SOD of the same date that
are not at issue on this appeal.’ Joint Stipulation (Jt. Stip.) 44 1-4, 9-10, 12-13.
Petitioner requested a hearing by an administrative law judge (ALJ) by letter dated
December 18, 2006. The case was assigned to me for hearing and decision on January
10, 2007, and a Notice of Case Assignment and Prehearing Case Development Order
(Prehearing Order) was issued at my direction on that date.

CMS notified Petitioner by letter dated January 18, 2007, that a mandatory DPNA was
effective January 17, 2007, and that it was imposing a CMP of $400 per day effective
October 17, 2006, and termination effective March 17, 2007, if substantial compliance
was not achieved before that date. The state agency determined after a revisit survey that
Petitioner returned to substantial compliance with program participation requirements on
February 1, 2007. Jt. Stip. {§ 11, 14. The parties agreed at hearing that only the alleged
violation of 42 C.F.R. § 483.25(h)(2) from the October 17, 2006 survey and the CMP of
$400 per day for the period October 17, 2006 through December 14, 2006, remain at
issue and subject to my review. Tr. 54-57; Jt. Stip. §§ 15-18.

A hearing was convened in Indianapolis, Indiana on July 17 and 18, 2007. A transcript
(Tr.) of the hearing was prepared. CMS offered and I admitted CMS exhibits (CMS Ex.)
1 through 28 and 46 through 51.7 Tr. 16-18. Petitioner offered and I admitted
Petitioner’s exhibits (P. Ex.) 1 through 86. Tr. 19. The parties submitted post-hearing
briefs (CMS Brief and P. Brief) and post-hearing reply briefs (CMS Reply and P. Reply).
Attached to Petitioner’s post-hearing brief were Petitioner’s proposed exhibits 87 through
89. CMS did not object to P. Exs. 87 through 89. I admit P. Exs. 87 through 89.

' Petitioner amended its request for hearing to challenge the findings of the December 15,
2006 survey, and the continuation of remedies based thereon. However, prior to hearing
the parties resolved all disputes related to the December 15, 2006 survey and the
continued remedies after that date.

> CMS notified me by letter dated July 11, 2007, that it withdrew proposed CMS Exs. 29
through 45.
IL. Discussion
A. Issues
The issues in this case are:
Whether there is a basis for the imposition of an enforcement remedy; and,
Whether the remedy imposed is reasonable.
B. Applicable Law

The statutory and regulatory requirements for participation by a long-term care facility
are found at sections 1819 (SNF) and 1919 (NF) of the Social Security Act (Act) and at
42 C.F.R. Part 483. Section 1819(h)(2) of the Act vests the Secretary with authority to
impose enforcement remedies against a SNF for failure to comply substantially with the
federal participation requirements established by sections 1819(b), (c), and (d) of the
Act. Pursuant to section 1819(h)(2)(C), the Secretary may continue Medicare payments
to a SNF not longer than six months after the date the facility is first found not in
compliance with participation requirements. Pursuant to section 1819(h)(2)(D), if a SNF
does not return to compliance with participation requirements within three months, the
Secretary must deny payments for all individuals admitted to the facility after that date —
commonly referred to as the mandatory or statutory DPNA. In addition to the authority
to terminate a noncompliant SNF’s participation in Medicare, the Act grants the
Secretary authority to impose other enforcement remedies, including a discretionary
DPNA, civil money penalties, appointment of temporary management, and other
remedies such as a directed plan of correction. Act § 1819(h)(2)(B).

The Secretary has delegated to CMS and the states the authority to impose remedies
against a long-term care facility that is not complying substantially with federal
participation requirements. “Substantial compliance means a level of compliance with
the requirements of participation such that any identified deficiencies pose no greater risk
to resident health or safety than the potential for causing minimal harm.” 42 C.F.R.

§ 488.301 (emphasis in original). A deficiency is a violation of a participation
requirement established by sections 1819(b), (c), and (d) of the Act or the Secretary’s
regulations at 42 C.F.R. Part 483, Subpart B. Facilities that participate in Medicare may
be surveyed on behalf of CMS by state survey agencies in order to determine whether the

> Section 1919(h)(2) of the Act gives similar enforcement authority to the states to
ensure that NFs comply with their participation requirements established by section
1919(b), (c), and (d) of the Act.
facilities are complying with federal participation requirements. 42 C.F.R. §§ 488.10-
488.28, 488.300-488.335. The regulations specify the enforcement remedies that CMS
may impose if a facility is not in substantial compliance with Medicare requirements.
42 CFR. § 488.406.

The regulations specify that a CMP that is imposed against a facility on a per day basis
will fall into one of two ranges of penalties. 42 C.F.R. §§ 488.408, 488.438. The upper
range of CMP, $3050 per day to $10,000 per day, is reserved for deficiencies that pose
immediate jeopardy to a facility’s residents, and in some circumstances, for repeated
deficiencies. 42 C.F.R. §§ 488.438(a)(1)(i), (d)(2). Pursuant to 42 C.F.R. § 488.301,
“(i)mmediate jeopardy means a situation in which the provider’s noncompliance with one
or more requirements of participation has caused, or is likely to cause, serious injury,
harm, impairment, or death to a resident.” (Emphasis in original.) The lower range of
CMP, $50 per day to $3000 per day, is reserved for deficiencies that do not constitute
immediate jeopardy but either cause actual harm to residents, or cause no actual harm,
but have the potential for causing more than minimal harm. 42 C.F.R.

§ 488.438(a)(1)(ii).

The Act and regulations make a hearing before an ALJ available to a long-term care
facility against which CMS has determined to impose an enforcement remedy. Act

§ 1128A(c)(2); 1866(h); 42 C.F.R. §§ 488.408(g); 498.3(b)(13). The hearing before an
ALJ is a de novo proceeding. Anesthesiologists Affiliated, et al, DAB CR65 (1990),
aff'd, 941 F.2d 678 (8th Cir. 1991); Emerald Oaks, DAB No. 1800, at 11 (2001);
Beechwood Sanitarium, DAB No. 1906 (2004); Cal Turner Extended Care, DAB No.
2030 (2006); The Residence at Salem Woods, DAB No. 2052 (2006). A facility has a
right to appeal a “certification of noncompliance leading to an enforcement remedy.”

42 CFR. § 488.408(g)(1); see also 42 C.F.R. §§ 488.330(e) and 498.3. However, the
choice of remedies by CMS or the factors CMS considered when choosing remedies are
not subject to review. 42 C.F.R. § 488.408(g)(2). A facility may only challenge the
scope and severity level of noncompliance found by CMS if a successful challenge would
affect the range of the CMP that could be imposed by CMS or impact the facility’s
authority to conduct a nurse aide training and competency evaluation program. 42 C.F.R.
§§ 498.3(b)(14) and (d)(10)(i). The CMS determination as to the level of noncompliance
“must be upheld unless it is clearly erroneous” (42 C.F.R. § 498.60(c)(2)), including the
finding of immediate jeopardy. Woodstock Care Center, DAB No. 1726, at 9, 38 (2000),
aff'd, Woodstock Care Center v. Thompson, 363 F.3d 583 (6th Cir. 2003). The
Departmental Appeals Board (the Board) has long held that the net effect of the
regulations is that a provider has no right to challenge the scope and severity level
assigned to a noncompliance finding, except in the situation where that finding was the
basis for an immediate jeopardy determination. See e.g., Ridge Terrace, DAB No. 1834
(2002); Koester Pavilion, DAB No. 1750 (2000). Review of a CMP by an ALJ is subject
to 42 C.F.R. § 488.438(e).
The standard of proof or quantum of evidence required is a preponderance of the
evidence. CMS has the burden of coming forward with the evidence and making a prima
facie showing of a basis for imposition of an enforcement remedy. Petitioner bears the
burden of persuasion to show by a preponderance of the evidence that it was in
substantial compliance with participation requirements or any affirmative defense. See
Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Ctr.
v. United States Dep’t of Health and Human Services, Health Care Fin. Admin., No. 98-
3789 (GEB), slip op. at 25 (D.N.J. May 13, 1999); Cross Creek Health Care Center,
DAB No. 1665 (1998); Emerald Oaks, DAB No. 1800; Batavia Nursing and
Convalescent Center, DAB No. 1904 (2004), aff'd, Batavia Nursing & Convalescent Ctr.
v. Thompson, 129 F. App’x. 181 (6th Cir. 2005); Batavia Nursing and Convalescent Inn,
DAB No. 1911 (2004).

C. Findings of Fact, Conclusions of Law, and Analysis
My conclusions of law are set forth in bold followed by my findings of fact and analysis.

1. Petitioner was in violation of 42 C.F.R. § 483.25(h)(2) (Tag F324)
from October 17, 2006 through December 14, 2006.

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). The Board has explained the
requirements of 42 C.F.R. § 483.25(h)(2) in numerous decisions. See e.g., Eastwood
Convalescent Center, DAB No. 2088 (2007); Liberty Commons Nursing and Rehab -
Alamance, DAB No. 2070 (2007); Golden Age Skilled Nursing & Rehabilitation Center,
DAB No. 2026 (2006); Estes Nursing Facility Civic Center, DAB No. 2000 (2005);
Northeastern Ohio Alzheimer's Research Center, DAB No. 1935 (2004); Woodstock
Care Center, DAB No. 1726, at 28 (2000), aff'd, Woodstock Care Center v. Thompson,
363 F.3d 583 (6th Cir. 2003). Section 483.25(h)(2) does not make a facility strictly liable
for accidents that occur, but it does require that a facility take all reasonable steps to
ensure that a resident receives supervision and assistance devices that meet his or her
assessed needs and mitigate foreseeable risks of harm from accidents. Woodstock Care
Center v. Thompson, 363 F.3d at 589 (a SNF must take “all reasonable precautions
against residents’ accidents”). A facility is permitted the flexibility to choose the
methods of supervision it uses to prevent accidents, but the chosen methods must be
adequate under the circumstances. Jd. Whether supervision is “adequate” depends in
part upon the resident’s ability to protect himself or herself from harm. /d. Based on the
regulation and the cases in this area, CMS meets its burden to show a prima facie case if
the evidence demonstrates that the facility failed to provide adequate supervision and/or
assistance devices to prevent accidents, given what was reasonably foreseeable. Alden
Town Manor Rehabilitation & HCC, DAB No. 2054 (2006), at 5-6, 7-12. An “accident”
is “an unexpected, unintended event that can cause a resident bodily injury,” excluding
“adverse outcomes associated as a direct consequence of treatment or care (e.g., drug side
effects or reactions).” State Operations Manual (SOM), App. PP, Tag F324; Woodstock
Care Center, DAB No. 1726, at 4.

The October 17, 2006 SOD alleges that Petitioner violated 42 C.F.R. § 483.25(h)(2) (Tag
F324) in the case of four residents identified as Residents A, B, C, and D and that
Residents B and C suffered actual harm as a result. CMS Ex. 1; P. Ex. 1.

(a) The examples cited by the surveyors involving Residents A
and D do not show violations of 42 C.F.R. § 483.25(h)(2) for
failure to use gait belts while transferring or ambulating the
residents.

(b) Petitioner’s failure to ensure that the alarm in Resident D’s
wheelchair was properly attached and operating is a violation of
42 C.F.R. § 483.25(h)(2), based upon the facts of this case.

Resident A is discussed in example 2 under Tag F324 in the SOD (CMS Ex. 1, at 9-12;
P. Ex. 1, at 9-12) and Resident D is discussed in example 4 (CMS Ex. 1, at 22-25; P. Ex.
1, at 22-25). I discuss the two examples and residents together as I conclude neither
example describes a violation of 42 C.F.R. § 483.25(h)(2) related to the use of gait belts.
However, I conclude that Petitioner did violate 42 C.F.R. § 483.25(h)(2) by failing to
ensure that Resident D’s wheelchair alarm was attached and on as required by her care
plan.

(1) Resident A, Example 2.

Resident A was a 77-year old female who was admitted to Petitioner’s facility in May of
1999. P. Ex. 9; Jt. Stip. 5. Resident A was dependent on staff for all activities of daily
living and was assessed as requiring a two person assist for transfers. Resident A
suffered from dementia, she could rarely or never be understood or understand others, she
ad severely impaired decision-making ability, and she was incontinent of bowel and
bladder, and she weighed 148 pounds. CMS Ex. 15, at 13-14, 18; P. Ex. 18, at 1. Her
care plan reflects that she was assessed as at risk for falls and required a two person assist
or transfers. CMS Ex. 15, at 18. Her Certified Nurse Aide (CNA) instructions or CNA
care plan provided that she required assistance of two staff or a Hoyer lift for transfers.
CMS Ex. 17, at 112. On September 27, 2006 at about 5 p.m., two CNAs were
transferring the resident by each holding her under an arm and holding onto her
incontinence brief. The incontinence brief broke, one of the CNAs felt that Resident A

would fall, and so they lowered the resident to the floor. According to nurse’s notes and
Petitioner’s incident form, Resident A was not injured and the CNAs were counseled
about the “importance of not using a brief as a transfer aid” and given in-service training.
CMS Ex. 15, at 8, 9.

The surveyors cited Petitioner for violation 42 C.F.R. § 483.25(h)(2) based upon the
September 27, 2006 incident because the CNAs were not using a gait belt to transfer the
resident. CMS Ex. 1, at 11-12. CMS argues before me that 42 C.F.R. § 483.25(h)(2)
was violated because the CNAs used an improper transfer technique by not using an
assistive device such as a gait belt or a Hoyer lift. CMS Brief at 13-18; CMS Reply at 4-
7. CMS argues that when the Director of Nursing (DON) was interviewed, she admitted
that the CNAs should have used a gait belt to transfer Resident A. CMS Brief at 14;
CMS Ex. 1, at 11-12; CMS Ex. 15, at 2, Tr. 94, 113. CMS also relies upon the testimony
of Surveyor DeAnn Mankell to support its argument that the CNAs improperly
transferred Resident A and that the use of a gait belt or a Hoyer lift would have reduced
the risk of a fall. CMS Brief at 14; Tr. 95, 101. According to CMS, the improper transfer
of Resident A created the potential for more than minimal harm secondary to a fall
including skin tears, bruises, or broken bones. CMS Brief at 15; Tr. 96.

Petitioner contends that Resident A did not fall to the floor, but was properly lowered by
facility staff when they perceived that the resident might fall when the incontinence brief
tore. According to Petitioner, the facility’s staff members are trained to protect residents
who begin to fall by lowering them to the floor. Petitioner argues that there is no
regulation, standard of care, or facility policy that requires the use of a gait belt during all
resident transfers. Petitioner cites the testimony of Petitioner’s Executive Director
(Administrator), Paula Powers, and its Rehabilitation Coordinator, Carly Runyon, that
CNAs are taught to assess the specific situation and use their best judgment as to how to
transfer a particular resident. Petitioner cites the testimony of Administrator Powers that
Resident A had fragile skin and wore open-backed clothing and that use of a gait belt
could cause skin injury. P. Brief at 5-7; Tr. 282, 306, 334. Petitioner calls my attention
to the testimony of Surveyor Mankell who testified that there was more than one safe
technique for transferring a resident and that there is no requirement to use a particular
assistive device. P. Brief at 7-8; Tr. 97-98, 107, 111-13. Petitioner does not deny that its
nurses concluded after investigation that the two CNAs had not used the optimal
technique when transferring Resident A and that the CNAs were instructed to use gait
belts in the future. P. Brief at 8; P. Ex. 22. Petitioner asserts that CMS does not allege or
offer evidence that there was any injury or even a risk for more than minimal harm in this
example related to Resident A. P. Brief at 8. Petitioner argues that CMS has not made a
prima facie showing of a violation of 42 C.F.R. § 483.25(h)(2) based on the example of
Resident A because CMS failed to show that there was any legal standard or standard of
care that required the use of a gait belt that the CNAs conduct violated. P. Brief at

19-20.

Petitioner is obliged by the regulation to take reasonable steps to ensure that a resident
receives supervision and assistance devices that meet his or her assessed needs and
mitigate foreseeable risks of harm from accidents. Two CNAs were assisting Resident A
when the incident occurred, thus supervision was being provided. The issue is whether
the failure of the CNAs to use an assistive device for transferring Resident A, specifically
a gait belt or a Hoyer lift, resulted in a violation of 42 C.F.R. § 483.25(h)(2). The
pertinent facts are not disputed. Resident A’s care plan authorized staff to transfer her
with a two person assist or with a Hoyer lift. CMS Ex. 15, at 18; CMS Ex. 17, at 112.
On September 27, 2006, two CNAs were transferring Resident A by lifting her under her
arms and by holding onto her incontinence brief.’ Surveyor Mankell testified that
transfers are usually made by lifting a resident under the arms. Tr. 94. The surveyors did
not cite Petitioner because its staff held the resident’s incontinence brief but, rather,
because staff failed to use a gait belt. CMS makes the additional argument before me that
a Hoyer lift should have been used as an alternative.

I conclude that the example of Resident A does not show a violation of 42 C.F.R.

§ 483.25(h)(2) based upon the testimony of Surveyor Mankell. Surveyor Mankell
testified in response to my questions that she concluded an improper transfer occurred
because the two CNAs were immediately in-serviced and told that they needed to use a
gait belt. However, Surveyor Mankell testified that there was no requirement to use a
gait belt or a Hoyer lift given the facts related to Resident A. Tr. 96-100, 112.
Administrator Powell agreed that there was no regulatory requirement, standard of care,
or policy that required staff to use a gait belt to accomplish a transfer by two person
assist. Tr. 333-39. Absent a statutory or regulatory requirement to use a gait belt to
accomplish a transfer by two person assist, failure to use a gait belt is not a per se
violation of a condition of participation including 42 C.F.R. § 483.25(h)(2). Furthermore,
the weight of the evidence is that it is neither a standard of care nor a policy requirement
of Petitioner that a gait belt be used to accomplish a transfer by two person assist.
Rather, the weight of the evidence indicates that the standard of care is to permit staff to
accomplish a two person assist by lifting a resident under the arms and to determine
whether an assistive device is reasonably required or not. Thus, failure to use a gait belt
did not amount to a failure to take reasonable steps to protect against accidentally

+ Surveyor Mankell indicated that she believed that the CNAs did not grab the resident’s
incontinence brief until the resident started to slip from their grasp. Tr. 93-94, 116-17.
However, Petitioner’s contemporaneous records state that the CNAs were transferring
Resident A by holding her under each arm and holding onto her brief and when the brief
broke one of the CNAs felt she would fall so they lowered her to the floor. CMS Ex. 15,
at 8. The evidence does not show whether the CNAs were actually lifting Resident A
with her brief although the fact that the brief broke permits an inference that there was
some weight applied to the brief.
dropping or otherwise injuring Resident A. In fact, in this case the evidence shows that
use of a gait belt also posed a risk of injury and to permit the CNAs discretion to
determine the appropriate assistive devices was reasonable. Similarly, there is no
regulatory requirement, standard of care, or policy that required the CNAs to use a Hoyer
lift for transferring Resident A. The resident’s care plan permitted the CNAs discretion
to do a two person transfer or use the Hoyer lift. Permitting the CNAs discretion is not
inconsistent with the standard of care according to the evidence before me.

(2) Resident D, Example 4.

Resident D is cited by the surveyors as example 4 in the SOD. CMS Ex. 1, 22-25; P. Ex.
1, 22-25. Resident D was a 55-year old female who was admitted to Petitioner’s facility
in May of 2003. P. Ex. 71. Resident D suffered from moderate mental retardation,
osteoporosis, obesity, a brain injury, and a previous right leg fracture. CMS Ex. 18, at 1;
P. Ex. 71. Resident D required extensive assistance of one person for transfers, toileting,
and walking. P. Ex. 74, at 2-3. She was assessed as being at high risk for falls. CMS Ex.
18, at 17-18; P. Ex. 75, at 1-2. Her care plan included ten interventions to address her
potential for falls, prior to September 27, 2006, including the requirement for an alarm in
her wheelchair. The intervention of a two person assist for transfers was added on
September 27. CMS Ex. 18, at 30.

According to Petitioner’s records, on September 27, 2006, at 4:50 a.m., one CNA was
transferring Resident D from the toilet to her wheelchair. Resident D stated that her right
leg “gave out” due to right hip pain and the CNA had to lower the resident to the floor.
The resident told the nurse that the pain was present before her leg gave out. CMS Ex.
18, at 10, 13-14, 34; P. Ex. 79, at 5; P. Ex. 85; P. Ex. 86. Petitioner’s accident/incident
committee review shows that the resident suffered no injury from the incident. CMS 18,
at 13; P. Ex. 86. According to Petitioner’s records, Resident D had a history of an old
fracture of her right femur that had been fixed with an intramedullary rod and screw,
possibly the source of the resident’s pain. CMS Ex. 18, at 12, 13, 29.

The surveyors allege in example 4 of the SOD that Petitioner violated 42 C.F.R.

§ 483.25(h)(2) because: (1) the surveyor observed the resident in her wheelchair at a
table in the dining room without her string alarm attached to her wheelchair and the alarm
was not turned on; and (2) staff do not always use the gait belts assigned to them. CMS
argues that Petitioner violated 42 C.F.R. § 483.25(h)(2) because the CNA did not use a
gait belt to transfer Resident D and Petitioner failed to ensure that the wheelchair alarm
intervention was used properly. CMS Brief at 24-26; CMS Reply at 21-23.

Petitioner argues that Resident D did not fall to the floor, but was properly lowered to the
floor by the CNA on September 27, 2006. Petitioner points out that a goal of Resident
D’s care plan was for her to ambulate and that it was not out of the ordinary for her to
suddenly sit down on the ground when ambulating. Petitioner argues, as it did related to
10

the example of Resident A, that there is no regulation or standard of care that a gait belt
be used for transferring or walking a resident, and the facility does not require its staff to
use a gait belt during all resident transfers. P. Brief at 16-17; P. Reply at 11-12.
Petitioner argues based on the testimony of Surveyor Carlson and Administrator Powers
that there was no evidence that the resident was lowered to the floor in a way that was not
safe, and the CNA prevented injury by lowering Resident D to the floor. P. Brief at 17;
Tr. 251, 357-358. Petitioner argues that given Resident D’s weight, not using a gait belt
may have been safer for the resident. P. Brief at 16. Petitioner argues, regarding the
unhooked alarm observed by the surveyor, that it was not mentioned in testimony at
hearing, that a sounding alarm would be annoying to other residents during meals, and
that one would think that residents are more closely supervised in the dining room so that
the alarm would be unnecessary. P. Reply at 12.

There is no dispute that during the survey on October 13, 2006 at about 11:10 a.m.,
Surveyor Lisa Carlson observed Resident D in the dining area in her wheelchair, an alarm
was attached to the back of her wheelchair. The pull tab of the alarm was not attached to
the resident and the alarm box was not turned on. The DON who was present
commented to Surveyor Carlson that the alarm should have been attached and on. Tr.
194. The reported statement of the DON is consistent with the fact that Resident D’s care
plan required that she have an alarm in her wheelchair. CMS Ex. 18, at 30. Although the
care plan does not state that the alarm had to be on and appropriately attached to Resident
D while she was in her wheelchair, I have no difficulty inferring that the care planning
team intended that the alarm be properly used when the intervention was added to the
care plan on September 5, 2006. The fact that the intervention was added indicates that
the care planning team determined that the intervention was reasonable and necessary to
address the problem identified in the care plan, which was the potential for injuries due to
alls, and the care planning team’s assessment and intervention appears to have been
made consistent with the requirements of 42 C.F.R. § 483.20(k). Petitioner did not
present evidence to show that the care planning team determined that the use of the alarm
was unnecessary while Resident D was in the lunch room because supervision of the
resident was sufficient at such times to obviate the need for the alarm. Petitioner’s
speculation that the noise of an alarm in the dining area would disturb other residents and
Petitioner’s assumption that there would be adequate supervision in the dining area, are
no substitute for evidence that Petitioner took reasonable steps to avoid harm to Resident
D due to a fall from her wheelchair. Accordingly, I conclude that Petitioner violated 42
C.F.R. § 483.25(h)(2) by failing to ensure that the alarm in Resident D’s wheelchair was
properly attached and operable when observed by the surveyor.

The facts related to the incident on September 27, 2006 are also not in dispute. One CNA
was transferring Resident D from the toilet to her wheelchair. Resident D stated that her
right leg “gave out” due to right hip pain and the CNA had to lower the resident to the
floor. The resident told the nurse that the pain was present before her leg gave out. CMS
Ex. 18, at 10, 13-14, 34; P. Ex. 79, at 5; P. Ex. 85; P. Ex. 86. The resident’s care plan did

11

not require more than a one person assist at the time of the incident. Administrator
Powers testified that the investigation of the incident revealed that the CNA was not
using a gait belt. Tr. 357.

I conclude that the CNA’s failure to use a gait belt for the transfer of Resident D on
September 27, 2006, did not result in a violation of 42 C.F.R. § 483.25(h)(2) based upon
a rationale similar to that discussed in the example of Resident A. Absent a statutory or
regulatory requirement to use a gait belt to accomplish a transfer of a resident, failure to
use a gait belt is not a per se violation of a condition of participation including 42 C.F.R.
§ 483.25(h)(2). Further, it is consistent with the standard of care to permit a CNA to
determine whether or not to use a gait belt when the use of a gait belt is not required by
the resident’s care plan or by facility policy. Failure to use a gait belt did not amount to a
failure to take reasonable steps to protect against accidentally dropping or otherwise
injuring Resident D in this case.

(c) Petitioner violated 42 C.F.R. § 483.25(h)(2) in the case of
Resident B as alleged in Example 1 of the SOD.

The alleged violation regarding Resident B is cited as example | in the SOD. CMS Ex.
1, at 2-9; P. Ex. 1, at 2-9. Resident B was admitted to Petitioner’s facility in November
2001 and she was 66 at the time of the survey. Her diagnoses included Alzheimer’s
disease, osteoporosis, dementia, hypertension, depression and a seizure disorder. P. Ex.
23, at 1. Her Minimum Data Set (MDS) with an assessment reference date of September
13, 2006, reflects that her cognitive skills for daily decision-making were severely
impaired, she seldom understood or made herself understood, and she was totally
dependent on others and required a one or two-person assist for all her activities of daily
living. CMS Ex. 16, at 29-30; P. Ex. 24, at 2-3. Resident B was assessed as being at
high risk for falls and she had a history of falls. CMS Ex. 16, at 54; P. Ex. 25. She was
also assessed as have an excessive forward trunk flexion, i.e. she leaned forward
excessively particularly when sitting. CMS Ex. 16, at 34-35; P. Ex. 35,37. Resident B’s
care plan recognizes that she was at risk for injury due to falls and includes hand-written
notes indicating numerous falls and two instances when seizures were observed. The
falls care plan lists factors contributing to her risk for injury due to falls including her
lack of safety awareness, severe cognitive impairment, seizure disorder, and the fact that
she leans and slides forward, including on the toilet. The care plan indicates that on
September 20, 2006, Resident B received a Broda™ chair.’ Her care plan provided that
she was to be in a reclining position at all times except while feeding until Occupational

* A Broda chair is an adjustable wheelchair, with side wings on the back to keep the
person in the chair upright, a back that reclines, and a seat that can be adjusted. Tr. 79;
P. Ex. 46.
12

Therapy evaluated her;° she was to be observed while in a wheelchair for improper
body/trunk alignment or positioning and she was to be repositioned as necessary.

CMS Ex. 16, at 53-54.” Physical therapy records show that on September 19, 2006,
Resident B was issued the Broda chair to address her poor sitting posture. The records
reflect that Resident B was to be reclined slightly back while sitting in the Broda chair to
keep her from slumping and sliding forward, staff received in-service training on proper
positioning between September 19 and 25, 2006, and Resident B was discontinued from
physical therapy on September 25, 2006. P. Ex. 37; CMS Ex. 16, at 42, 44-46. The
physical therapy records do not mention whether or not Resident B was to be upright
while feeding. The in-service training record dated September 19-25, 2006 lists as
objectives that Resident B was to be in a comfortable sitting position in her Broda chair
with the seat’ tilted slightly backward at 110 degrees to prevent her from slumping or
sliding in the chair, and she was to be supervised at all times. CMS Ex. 16, at 36; P. Ex.
47, at 1.

On October 13, 2006, the special unit care manager pointed out to the surveyor that
Resident B had fallen and had staples in her forehead. The surveyor recorded in the SOD
that she observed that Resident B had a line of staples in the center of forehead
approximately three inches long running from her forehead into her hairline. CMS Ex. 1,
at 2-3. Based upon a records review, the surveyor alleged in the SOD that on October 4,
2006 at approximately noon, Resident B was in her Broda chair for lunch sitting upright
because her husband did not want her reclined as much. Staff concluded that the brakes
on the Broda chair were not locked. Staff heard a loud noise and they found Resident B
laying face down on the floor in the dining room, with her Broda chair behind her, and a
large amount of blood from a three to four inch cut on the top middle of her forehead.
CMS Ex. 1, at 5-9.

° The date that this approach was added is difficult to read but it appears to be October 5,
2006, the day after the fall, which is consistent with other evidence from Petitioner’s
records discussed hereafter.

7 The care plan admitted by CMS at CMS Ex. 16, at 53-54 is dated January 12, 2006
with updates and changes dated to October 2006 and an updated target date of December
20, 2006. Petitioner submitted a care plan for Resident B dated October 13, 2005 with
updates and changes dated to November 2005 and a revised target date of April 18, 2006.
P. Ex. 27.

* T conclude that the physical therapist meant that the seat-back needed to be reclined
back at 110 degrees or 20 degrees off of vertical. The seat bottom was adjustable but
adjusting it to 110 degrees is nonsensical.
13

Petitioner’s records reflect the following facts. Petitioner’s Incident Report dated
October 4, 2006, indicates that at 12 p.m. Resident B was in the dining room sitting in an
upright position in her Broda chair at the table for the afternoon meal; facility staff was
passing out trays and feeding other residents; and Resident B fell out of her Broda chair.
The report indicates that Resident B was upright because her husband insisted. The
report also listed as a preventive measure that the brakes on the Broda chair would be
locked during meal times. CMS Ex. 16, at 6-7. The statements of staff present in the
dining room indicate that no staff observed Resident B leaning forward before the fall,
but no staff admitted to actually seeing Resident B fall. CMS Ex. 16, at 8-11, 15; P. Ex.
45, at 1-4. An Incident Follow-up & Recommendation Form signed by Administrator
Powers on October 5, 2006 states that on October 4, 2006 at 12 noon, Resident B was
found face down on the floor in the dining room, the resident fell forward out of her
Broda chair, and had a laceration to her forehead which required 13 staples. The report
isted follow-up actions of keeping the resident in a reclining position except for meals
until Occupational Therapy screened for possible thigh straps, locking the brakes on the
Broda chair at mealtime, and adding a personal alarm to the Broda chair. CMS Ex. 16, at
3, 55; P. Ex. 44, at 2.

Petitioner argues that Resident B had to be in an upright position while eating to permit
her to swallow properly as her dementia placed her at increased risk of aspiration citing
P. Ex. 36 and 37. P. Ex. 36 is a Rehabilitation Services Progress Notes form with an
entry dated October 5, 2006. The note indicates the resident was screened following her
fall on October 4, 2006 with the instruction that while she was up in her Broda chair she
was to be reclined 100 degrees when not eating. The note also states that nursing staff
was instructed on September 19 through 25, 2006, on the correct positioning of the
resident. The progress note was created the day after the fall. Further it refers to no prior
assessment of Resident B that showed she had difficulty swallowing or that being
reclined 10 degrees from vertical or straight-up would negatively impact her ability to
swallow. P. Ex. 1. P. Ex. 37 consists of physical therapy documents that include no
statement that Resident B needed to be in a vertical position in the Broda chair while
eating. Rather, the physical therapy documents are consistent that Resident B needed to
be reclined slightly for safety. P. Ex. 37. Furthermore, the in-service training record
dated September 19-25, 2006, states that Resident B was to be in a comfortable sitting
position in her Broda chair with the seat tilted slightly backward at 110 degrees to
prevent her from slumping or sliding in the chair, and she was to be supervised at all
times. The training record does not indicate that staff was trained to place Resident B in
an upright position when she was eating. CMS Ex. 16, at 36; P. Ex. 47, at 1. The care
plan Petitioner produced does not reflect an assessment indicating swallowing difficulty
or any intervention to address such a problem. P. Ex. 27. The resident’s MDS with an
assessment reference date of September 13, 2006, does not indicate Resident B had a
swallowing problem. P. Ex. 24, at 3 (Block K1.b.). The MDS does show that she was
totally dependent upon staff for eating and required the assistance of one, from which I
infer that Resident B was not eating when she fell forward from her chair as she was not

14

then attended by anyone. P. Ex. 24, at 3 (Block G1.h.). I further note that Petitioner’s
incident report states that “Resident place in upright position per POA [Power of
Attorney — her husband] request against therapies recommendations.” CMS Ex. 16, at 6.
The incident report also mentions that the husband was insistent that Resident B be in the
upright position. CMS Ex. 16, at 7. The incident report does not state nor suggest that
Resident B was placed in the upright position to be fed due to swallowing difficulty or a
risk of aspiration. Ms. Runyon testified that Resident B had dementia and was at risk for
aspirating while she was eating, thus, it was care planned that she would be upright while
eating. Tr. 287, 302. Ms. Runyon’s testimony in this regard is inconsistent with Resident
B’s September 13, 2006 MDS and not supported by Petitioner’s clinic evidence that was
admitted as evidence. Ms. Runyon opined that while Resident B needed supervision
while sitting up at 90 degrees to eat, she also opined that her supervisor did not need to be
right next to her and there was no way to catch her if she began to fall. Tr. 287-88.
Administrator Powers testified that she spoke with the physical therapist, Ms. Bagwan,
who provided the in-service training to staff on using the Broda chair with Resident B.
Administrator Powers testified that Ms. Bagwan told her that when she indicated the
resident needed supervision, she meant that someone needed to be in the vicinity of the
resident when she was in an upright position. She also testified that Resident B needed to
be upright for eating and also that the resident’s husband wanted her upright and he
would adjust the chair. Tr. 342-44. Administrator Powers’ testimony that Resident B
needed to be upright is not supported by the clinical records introduced for Resident B,
which include no indication that the resident had swallowing difficulty or had to be
upright to eat. Her testimony that Ms. Bagwan told her that by stating that Resident B
needed supervision while in her Broda chair meant only that staff needed to be in the
vicinity, has no probative value as it is impossible to determine what Ms. Bagwan meant
by “in the vicinity.”

I conclude after review of all the evidence related to Resident B and consideration of
Petitioner’s arguments, that Petitioner violated 42 C.F.R. § 483.25(h)(2) in the case of
Resident B. I have no doubt that the Broda chair was the appropriate assistance device
for Resident B based upon the evidence presented. However, the violation occurred due
to the lack of appropriate supervision of Resident B and the failure to follow the physical
therapists instructions based upon her assessment, that Resident B needed to be reclined
to 110 degrees and that she required supervision. Petitioner’s staff violated the specific
directions of the physical therapist by not using the Broda chair in a manner determined
to be safe by the physical therapist for the resident and also by failing to provide any
supervision for the resident at the time of the fall. The evidence before me includes no
care plan or instructions for how staff was to use the Broda chair with the resident other
than those provided by the physical therapist, instructions upon which staff was
specifically trained by the therapist. When Resident B fell, she was sitting upright at a 90
degree angle and unsupervised. Even if Petitioner is correct in its position that Resident
B needed to be upright to eat, there is no dispute that she was not eating at the time, a
conclusion that is consistent with the fact that she was assessed as being totally dependent
15

upon the assistance of one staff member to eat and that no staff member was with her.
Because she was not eating, there was no reason for her to be upright at the dining table.
lalso conclude that, contrary to the physical therapist’s instructions and training for staff,
Resident B was unsupervised when she fell. The evidence shows that no staff saw the
fall and therefore I conclude that no staff was supervising or even observing the resident
from within her “vicinity.” Petitioner has failed to show that the instructions of the
physical therapist were not reasonable means to minimize the risk for harm to Resident B
due to accidental injury or that Petitioner took other reasonable steps to accomplish the
same result.

I am also urged by CMS to consider that the wheels of Resident B’s Broda chair were not
locked at the time of the fall, a fact that is not disputed by Petitioner. Petitioner
introduced some manufacturer’s information regarding the Broda chair, but it contained
no specific instructions regarding the use of the chair or its features. P. Ex. 46. Ican
infer from the fact that the Broda chair had brakes that they were a safety feature
provided by the manufacturer. Petitioner presented no evidence that the brakes were not
to be applied when the chair was not being moved or that applying the brakes was not a
reasonable means to make the chair safer for any occupant of the chair. Petitioner’s
undisputed failure to ensure that a safety device provided by the chair manufacturer was
properly used permitting the chair to roll back when Resident B apparently pitched
forward in her chair, is an independent basis for finding a violation of 42 C.F.R.

§ 483.25(h)(2). However, I stress that even if staff locked the brakes and Resident B hit
her head on the table rather than the floor, Petitioner never the less violated 42 C.F.R.

§ 483.25(h)(2) by leaving the resident unsupervised in an upright position in her Broda
chair.

Accordingly, I conclude that Petitioner violated 42 C.F.R. § 483.25(h)(2) because it
failed to take reasonable steps to mitigate the foreseeable risk of harm due to accidental
injury by ensuring that the Broda chair, an appropriate assistance device, was properly
used and that Resident B had necessary supervision. Resident B suffered actual harm due
to the violation.

(d) Petitioner did not violate 42 C.F.R. § 483.25(h)(2) in the case
of Resident C as alleged in Example 3 of the SOD.

The alleged violation regarding Resident C is cited as example 3 in the SOD. CMS Ex.
1, at 12-22; P. Ex. 1, at 12-22. Petitioner is alleged to have violated 42 C.F.R.

§ 483.25(h)(2) in the case of Resident C on two bases, because Petitioner “failed to
prevent [Resident C] from falling and sustaining a fractured left hip and failed to ensure
the same resident had continuing care planned interventions in place.” CMS Ex. 1, at 2;
P. Ex. 1, at 2.
16

Resident C was nearly 98 when the survey occurred. She was admitted to Petitioner’s
facility in March 2004. Her diagnoses included senile dementia, diabetes, a cataract in
her left eye, degenerative joint disease, osteoporosis, osteoarthritis, hypertension, and
chronic dizziness, among others. P. Ex. 48, at 1; P. Ex. 49, at 1; CMS Ex. 17, at 6; Tr.
158. Her MDS with an assessment reference date of October 2, 2006, shows she required
extensive assistance of one or two staff for all activities of daily living except eating
which she could do with supervision after set-up; she could not balance while standing
without physical help; she had limited use of both arms, both hands, and both legs; she
was usually continent of bowel and occasionally incontinent of bladder; she had a
scheduled toileting plan; and she had fallen in the past 30 days and had a hip fracture
within the last 180 days. P. Ex. 53. She suffered from a neurogenic bladder and did not
want to be catheterized, causing frequent bathroom visits. P. Ex. 64. Resident C was
consistently assessed as being at high risk for falls and she had a history of falls. P. Ex.
55; P. Ex. 56, at 4. Resident C’s care plan, offered by Petitioner and dated May 25, 2006
with hand-written entries to January 2007, indicates she had falls on July 1, 2005, July 3,
2005 with a skin tear, August 22, 2005, November 12, 2005, a skin tear on August 29,
2006; September 2, 2006, and a couple more falls after the survey. Her care plan states in
the section captioned “Problem” that she had an alarming lap buddy in her wheelchair
that she was able to remove, an alarm on her bed, and an alarm on her bedside chair.
Interventions listed at the time of the survey included: reminding her to call for
assistance with transfers, keeping the call light within easy reach, and answering
promptly because Resident C attempts self-transfer; assistance of one or two for transfers;
quarterly restraint and fall assessments and as necessary with star on door; educating on
transfer techniques; alarming lab buddy in wheelchair, bed alarm, alarm in recliner, half
side-rails up on both sides when in bed; toileting plan upon rising, before and after meals,
at bedtime, and as needed; observing for incontinence and providing incontinence care as
needed; occupational therapy; physical therapy; observing alarm at least every shift and
as necessary due to history of disabling or disconnecting; keeping the wheelchair close to
the recliner when she was in the recliner; and the use of skin sleeves. P. Ex. 56, at 4-5;
CMS Ex. 17, at 30-31, 112. The copy of the care plan offered as evidence by Petitioner
includes changes and interventions added after the survey: the lap-buddy in the
wheelchair was discontinued in December 2006; in January 2007 she was placed in a low
bed with floor mats; on October 27, 2006 a personal alarm was applied to the wheelchair
with the alarm box under the seat so Resident C could not reach it and disable the alarm;
and in January 2007 she received a concave mattress for her bed and a pommel cushion
for her wheelchair. P. Ex. 56, at 4-5. I note that both copies of the care plan in evidence
are dated May 25, 2006 and I infer that all the printed entries were on the care plan when
it was prepared in May 2006. There are only three hand-written interventions on the
copy of the care plan obtained by CMS during the survey and admitted at hearing as
CMS Ex. 17, at 30-31, including physical therapy for transfers, standing, and gait among

17

other things; keeping wheelchair close to the recliner; and use of skin sleeves. No dates
are discernable on the copies admitted as evidence for the first two hand-written
interventions but the note regarding the skin sleeves is dated September 6, 2006.” CMS
Ex. 17, at 30-31; P. Ex. 56, at 4-5. I infer that the other hand-written entries were made
sometime between May 25, 2006 and the October 2006 survey and that inference is
consistent with a Nurse’s Notes entry dated September 6, 2006, that indicates that placing
the wheelchair near the recliner was discussed during a fall risk assessment review and a
September 20, 2006 Nurse’s Notes entry and a doctor’s order dated September 20, 2006,
that indicate the resident’s doctor issued a new order for physical therapy five times per
week for three weeks for therapeutic exercises related to transfers, standing, and gait,
among other things. P. Ex. 61, at 19 and 22; P. Ex. 59, at 11. A new order for physical
therapy was issued on October 11, 2006, for an additional four weeks. P. Ex. 59, at 13.

The SOD records that on October 13, 2006 at 1:02 p.m., Surveyor Carlson saw Resident
C in her wheelchair in the bathroom. Resident C was not attended and the Velcro strap of
her alarming lap buddy was unhooked from one side of her wheelchair but the alarm was
not sounding. Resident C was leaning forward in her wheelchair, pulling down on the
waistband of her pants and lifting her top. At 1:03 p.m. a CNA entered the bathroom and
assisted the resident in the use of the toilet. The CNA told Surveyor Carlson that she did
not know why the lap buddy alarm did not sound but the resident was known to unfasten
and then fasten the Velcro so staff did not catch her trying to get up. When the CNA
tested the alarm by attaching and then unhooking the alarm, it sounded properly. CMS
Ex. 1, at 12-13; P. Ex. 1, at 12-13; Tr. 163-66, 236-244, 259-60. Surveyor Carlson
testified that she was concerned because she found the resident alone in the bathroom,
appearing to ready herself to self-transfer, with the lap buddy detached and not alarming,
and that there was a risk the resident might fall. Tr. 165-66. Surveyor Carlson opined
that Petitioner’s interventions were not working because Resident C continued to attempt
self-transfers. Tr. 164. Surveyor Carlson also testified that the interventions on Resident
C’s care plan were not effective to prevent her self-transfers or a fall on September 2,
2006, that she believed resulted in a fractured hip. Tr. 175. Surveyor Carlson opined that
through the date of the October 2006 survey, Petitioner did not provide Resident C
adequate supervision or assistive devices to prevent falls and that there was a risk for
more than minimal harm. Tr. 190. She also testified that she did not find evidence that
Petitioner consistently implemented other interventions on Resident C’s care plan. Tr.
244-48. She testified that Petitioner could have attempted to use either a pommel cushion
or a pressure pad alarm with Resident C to deter or prevent self-transfers. Tr. 253.

° An Accident/Incident Committee Review form dated September 1, 2006, indicates that
skin sleeves were initiated on that date to address the problem of the resident causing a
skin tear on her wrist when she propelled herself into the bathroom door frame.
18

Petitioner offered as evidence Nurse’s Notes forms dated from May 12, 2006 through
November 2, 2006. P. Ex. 61. Review of the notes for the period May 25, 2006, the date
of her care plan, through October 17, 2006, the last day of the survey, reveals the
following: from May 25 to July 9, 2006, there were 33 entries that indicated the resident
was noncompliant with her lap buddy, that one or more attempts were made by the
resident to unhook her lap buddy, and/or to self-transfer to the toilet or her recliner, some
entries reflect that staff responded to the lap buddy alarm or otherwise caught the resident
in the act of transferring, and many entries indicate the resident was instructed to use her
call-light; between May 25 and July 9, 2006, the fall risk committee considered the
resident’s case on May 30, June 6, and on June 14, 2006; from July 10 through
September 1, 2006, no incidents are reported. P. Ex. 61, at 5-16.

The parties agree that Resident C fell on September 2, 2006, and it was subsequently
discovered on about September 25, 2006 (P. Ex. 63, at 3-4; P. Ex. 64, at 6) that Resident
C had a fractured left hip. A Nurse’s Notes entry dated September 2, 2006 at 4:30 p.m.
indicates that Resident C attempted to transfer herself from her lounge chair to her
wheelchair, she grabbed the blankets to hold on to and when they gave way, she fell on
her left hip. She complained of slight pain in her left hip. P. Ex. 61, at 17. A post-fall
assessment dated September 2, 2006, provides little additional detail except that it
indicates a chair alarm was placed in the resident’s lounge chair. P. Ex. 69. A September
5, 2006 entry on an Accident/Incident Committee Review form indicates that on
September 2, 2006 Resident C was sitting in her recliner, the CNA had just left the room
a minute or less before the resident attempted to transfer from her recliner to her
wheelchair, when she grabbed the blankets on her bed to help her stand-up they came
loose and the resident fell to her buttocks, she used the call light to call for assistance.
The intervention ordered was for the CNAs to keep the residents wheelchair close to her
recliner when she was sitting in the recliner, and she only needed a limited assist to
transfer but could not ambulate. P. Ex. 70, at 2. An Incident Follow-Up &
Recommendation Form dated September 5, 2006, indicates that on September 2, 2006, at
4:30 p.m. the resident was found on the floor in front of her recliner and next to the bed,
and that she had attempted transferring from the recliner to the bed. The intervention
ordered was to keep the wheelchair locked and next to the recliner when the resident was
in the recliner. The note also indicates that CNAs were to be in-serviced regarding
placing the wheelchair “in front of recliner.” CMS Ex. 17, at 75. A Nurse’s Notes entry
dated September 6, 2006 at 1:20 p.m., shows that the fall risk committee met and
reviewed the resident’s fall risk and she scored 14; the decision was made to continue the
alarming lap buddy; the note states “alarm bed & w/c;” and that the wheelchair was to be
placed close to the recliner when the resident was in the recliner. P. Ex. 61, at 19.
According to Petitioner’s care plan dated May 25, 2006, she was supposed to have a bed
alarm prior to September 6 and the note is not clear whether a new bed alarm was added
or whether the decision was to continue the bed alarm. Although the note indicates that
there was to be an alarm in Resident C’s wheelchair, it is not clear whether this was an
error and that the note should have stated recliner rather than wheelchair, but there is no

19

evidence of any alarm used in the resident’s wheelchair from May 25, 2006 through the
date of the survey, except the alarming lap buddy. The Nurse’s Notes from September 2,
2006, after the fall, through October 17, 2006 include eight entries that indicated the
resident was noncompliant with her lap buddy, that one or more attempts were made by
the resident to unhook her lap buddy, and/or to self-transfer to the toilet or her recliner.
These entries include: September 13, Resident C attempted to self-transfer after
breakfast but the nurse heard the alarm, assisted the resident, and reminded her to call for
help; September 28, the resident removed her lap buddy twice on the evening shift
apparently planning on transferring herself to the toilet;'° September 29, the resident
removed the lap buddy during the morning shift to transfer herself to her recliner, staff
assisted and reminded her to use her call light; September 29, during the evening shift the
resident attempted to self-transfer to the toilet twice, the resident was assisted and
reminded to use the call light; September 30, Resident C attempted to self-transfer twice
during the morning, unhooking the lap buddy on her own; October 6, the resident
attempted to self-transfer to toilet after breakfast, the lap buddy alarm was heard and staff
assisted; and October 17, the resident attempted to transfer from her wheelchair to her
recliner. P. Ex. 61, at 17-25.

Physician’s orders reflect that Resident 8’s alarming lap buddy was intended to be an
“enabler” and she was to be able to release it upon command. P. Ex. 59, at 5; P. Ex. 60,
at 1-2. The physician’s order is consistent with a restraint verses enabler evaluations
dated January 16, 2006 and June 14, 2006, which indicate that the purpose was to remind
the resident to call for assistance with transfers and to alert staff that the resident was
attempting a transfer without assistance. P. Ex. 57, at 1-2.

CMS argues before me that Petitioner continued to follow a failed care plan for Resident
C that “never worked nor was even consistently implemented.” CMS Brief at 18; CMS
Reply at 7-8. CMS correctly asserts that Resident C continued to attempt self-transfers
after unhooking her alarming lap buddy. CMS incorrectly asserts that Petitioner failed to
do quarterly updates of the resident’s fall risk assessment. CMS points to interventions
implemented by Petitioner after the survey in support of its position that Petitioner failed
to implement new more effective interventions prior to the survey. CMS. Br. at 18-24;
CMS. Reply at 7-10.

Petitioner objected at hearing and in post-hearing briefing to my consideration of the fact
that Resident C fell and suffered a fractured hip on about September 2, 2006 as the basis
for imposition of an enforcement remedy. Petitioner argues that Petitioner was found in

© The note is not clear as to whether staff heard an alarm or simply caught the resident in
the act or whether the resident actually completed a transfer by herself. However, based
on the wording of the note, I conclude that the resident did not complete a transfer herself
but was assisted by staff which responded to the lap buddy sounding.
20

substantial compliance as of September 8, 2006, by a survey completed on September 29,
2006, and events prior to that finding should not be the basis for a deficiency citation or
an enforcement remedy. Tr. 20, 26-30, 39, 44; P. Brief at 25-30; P. Ex. 87, 88, 89. CMS
agreed that Resident C’s records were reviewed during a revisit survey to a prior
complaint survey that was completed on September 29, 2006 and no deficiencies were
cited and Petitioner was certified as being in substantial compliance. However, CMS
argued that the surveyors only reviewed the period from September 8 through 29, 2006.
Counsel for CMS stated that CMS relies upon evidence from before September 8 and
after September 29, 2006, but not the intervening period subject to review during the
revisit survey. Tr. 22-25. Counsel for CMS also asserted CMS proceeded upon the
theory that Resident C’s fractured hip on September 2, 2006, was appropriately
considered as actual harm when CMS determined the CMP to impose. Tr. 41-42.
Petitioner argued that it construed the statement of deficiency to be that Petitioner failed
“to do interventions following the fall and the fracture, but that . . . she wasn’t injured
again after the fracture.” Tr. 42-43. Surveyor Mankell testified that Resident C’s records
were reviewed during the revisit survey that ended on September 29, 2006. Tr. 140.
Surveyor Carlson testified that she participated in the survey that ended on September 29,
2006, and that the records of Resident C were reviewed for the period September 8
through 29, 2006 during that survey but no deficiency was cited based upon her treatment
or care. Tr. 195-97, 220. I find it unnecessary to resolve Petitioner’s objection because I
find no violation of 42 C.F.R. § 483.25(h)(2) based upon the facts related to Resident C
in example 3.

Based upon my review of all the evidence and consideration of the arguments of the
parties, I find no violation of 42 C.F.R. § 483.25(h)(2) based upon the facts related to
Resident C. The CMS argument that Resident C’s care plan had “failed” or was
ineffective is belied by the facts. In 2005, Resident C had several falls. The care plan in
question before me was adopted on May 25, 2006. CMS Ex. 17, at 30-31. Between May
25, 2006 and September 2, 2006, the resident had no falls. Her clinical records show that
Resident C was being toileted as required by her care plan, she was being frequently
monitored, she received physical therapy regarding safe transfer techniques, she was
requently reminded to call for assistance rather than attempt self-transfers unassisted,
and her alarms were being checked. The evidence shows that the purpose of the lap
buddy was to remind the resident to call for help and to alert staff if she did not. The
clinical evidence shows that the lap buddy worked well both to remind the resident and to
alert staff. Administrator Powell testified that Resident C set off her lap buddy alarm
numerous times and staff responded, which is the purpose of the alarm. Tr. 352, 369.
The alarming lap buddy was not intended to be a restraint to prevent self-transfer and the
physician’s order specified that Resident C be able to release the lap buddy, albeit under
supervision. The fact that Resident C could release the lap buddy was not a violation of
the regulation. The fact that Surveyor Carlson found Resident C in her bathroom with

er lap buddy disconnected is not disputed. It is also not disputed that a CNA arrived in
the bathroom in no more than a minute according to the SOD and before Resident C

21

could attempt a self-transfer. Whether or not the CNA entered because she saw the
surveyor enter the room is pure speculation. The records show consistent toileting after
meals and consistently frequent monitoring of the resident, facts that are consistent with
an inference that the CNA entered the bathroom to monitor and toilet the resident rather
to intervene with the surveyor. CMS is correct that P. Ex. 55 only reflects fall risk
assessments on May 8 and October 9, 2006. However, other evidence shows Resident
C’s fall risk was assessed more often than quarterly as required by her care plan. During
the period May 25 through October 17, 2006, she was assessed four times in less than six
months and no more than 90 days passed between any two evaluations. P. Ex. 61, at 6, 9,
11, 17. The evidence does not indicate that an assessment was not done when it was
needed. Staff consistently recorded that the resident’s alarms were functioning and/or in
place and that the resident was receiving her toileting programs on rising, before and after
meals, at bed time, and as necessary. P. Ex. 65. When Resident C fell on September 2,
2006, she was attempting to transfer from her recliner to her bed or wheelchair (the
evidence is conflicting as to her destination) and the lap buddy was not involved. The
care plan required an alarm in the recliner but the evidence does not show if the alarm
was operating or sounded or whether staff could not respond in time to prevent the fall.
The evidence does show that staff did respond promptly when alerted by the resident with
the call light and found the resident sitting on the floor. Within days a new intervention
was added and staff was in-serviced to keep the wheelchair locked and next to the
recliner when the resident was in the recliner. Whether the intent of the intervention was
to block the resident from exiting her recliner (arguably a restraint), to remind her to call
for assistance, to give her a more stable assist than the bed linen, or to minimize the
distance she might attempt to ambulate when attempting a self-transfer, is not clear.

What is clear is that after the new intervention was added the record shows no further
attempt to transfer from the recliner prior to the survey.

I conclude that Petitioner has presented sufficient evidence to meet its burden to show by
a preponderance of the evidence that it provided adequate assistance devices and
supervision to mitigate the foreseeable risk of harm to Resident C due to accidental injury
from falls. Accordingly, Petitioner did not violate 42 C.F.R. § 483.25(h)(2) based upon
the facts related to Resident C.

2. There is a basis for the imposition of a CMP.

3. A CMP of $400 per day for the period October 17, 2006 through
December 14, 2006, is not reasonable, but a CMP of $200 per day for
the period is reasonable.

Ifa facility is not in substantial compliance with program requirements, CMS has the
authority to impose one or more of the enforcement remedies listed in 42 C.F.R.

§ 488.406, including a CMP. CMS may impose a CMP for the number of days that the
facility is not in compliance or for each instance that a facility is not in substantial
22

compliance. 42 C.F.R. § 488.430(a). There are two ranges for per day CMPs. 42 C.F.R.
§§ 488.408, 488.438. The upper range of CMP from $3050 per day to $10,000 per day is
for deficiencies that constitute immediate jeopardy to a facility’s residents, and, in some
circumstances, for repeated deficiencies. 42 C.F.R. §§ 488.438(a)(1)(D, (d)(2). There
was no finding of immediate jeopardy and the upper range is not applicable to this case.
The lower range of CMP from $50 per day to $3000 per day is for deficiencies that do
not constitute immediate jeopardy, but either cause actual harm to residents or cause no
actual harm but have the potential for causing more than minimal harm. 42 C.F.R.

§ 488.438(a)(1)(ii). The $400 per day CMP proposed by CMS in this case is at the low
end of the lower range of authorized CMPs.

In determining whether the amount of the CMP is reasonable, the following factors
specified at 42 C.F.R. § 488.438(f) must be considered: (1) the facility’s history of non-
compliance, including repeated deficiencies; (2) the facility’s financial condition; (3) the
seriousness of the deficiencies as set forth at 42 C.F.R. § 488.404; and (4) the facility’s
degree of culpability.

CMS proposed a $400 per day CMP based on the findings and conclusions that there
were four examples establishing Petitioner’s violation of 42 C.F.R. § 483.25(h)(2), two of
which involved actual harm. I conclude that Petitioner violated the regulation due to its
failure to ensure that Resident D’s wheelchair alarm was properly used and its failure to
ensure that Resident B was properly supervised in her Broda chair and that the chair was
properly used. I conclude that only Resident B suffered actual harm due to the regulatory
violation. I conclude that the regulatory violation was serious, but it was not as serious as
CMS may have considered based on the findings and conclusions of the survey. Thus,
adjustment of the CMP is reasonable. Resident B suffered a serious injury. Petitioner
stipulated it had the ability to pay. Tr. 16. Petitioner was culpable considering that
specific elements of its care plans for the two residents were not implemented. Petitioner
has not presented evidence to show it corrected the deficiency or achieved substantial
compliance prior to December 14, 2006. Based upon my evaluation of all the required
factors, I conclude that a $200 per day CMP for the period October 17 through December
14, 2006 (a total of 59 days), a total CMP of $11,800 is reasonable.

4. The burden of persuasion does not affect the outcome of this case.

5. Review of the reasonableness of the proposed enforcement remedy
was de novo and review of how CMS considered the regulator factors
when proposing an enforcement remedy is not relevant to my review.

Petitioner attempts to preserve two additional issues for appeal. Petitioner argues that the
allocation of the burden of persuasion in this case according to the rationale of the Board
in the prior decisions cited above violates the Administrative Procedures Act, 5 U.S.C.
23

§ 551 et. seq., specifically 5 U.S.C. § 556(d). Petitioner’s Prehearing Brief at 19.
Because the evidence is not in equipoise, the burden of persuasion did not affect my
decision, and Petitioner suffered no prejudice.

Petitioner also argues that the Medicare Act is violated and Petitioner is deprived of due
process if CMS is not required to submit evidence to prove it considered the regulatory
criteria established by 42 C.F.R. §§ 488.404 and 488.438(f). Petitioner’s Prehearing
Brief at 20. I reviewed the evidence related to the regulatory factors de novo and
perceive no prejudice to Petitioner because I did not require CMS to submit evidence
related to its consideration of the regulatory factors.

Il. Conclusion

For the foregoing reasons, I conclude that Petitioner violated 42 C.F.R. § 483.25(h)(2)
and a $200 per day CMP for the period October 17, 2006 through December 14, 2006,
totaling $11,800 is reasonable.

/s/
Keith W. Sickendick
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Decision No. CR1943
The Inspector General.

)
In the Case of: )
)

Gary Grossman, ) Date: May 4, 2009
)
Petitioner, )
)

- ve ) Docket No. C-09-227

)
)
)

DECISION DISMISSING REQUEST FOR HEARING

I dismiss the hearing request of Petitioner, Gary Grossman. I find that Petitioner received
notice of the Inspector General’s (1.G.) determination to exclude him from participating
in Medicare and other federally funded health care programs more than 60 days before
the date when Petitioner filed his hearing request. Therefore, and as a matter of law, I
must dismiss Petitioner’s request.

I. Introduction

On September 28, 2001 the I.G. mailed a notice to Petitioner informing Petitioner that he
was being excluded from participating in Medicare and other federally funded health care
programs for a period of 15 years. Petitioner did not request a hearing until January 9,
2009,” more than seven years after the mailing date of the exclusion notice.

I was assigned to hear and decide the case. The I.G. moved to dismiss Petitioner’s
hearing request on the ground that Petitioner filed it untimely. Petitioner opposed the
motion. I granted leave to the L.G. to file a reply brief. I also granted Petitioner leave to
file a surreply. The I.G. filed seven exhibits, which he identified as I.G. Ex. | — 1.G. Ex.

* The hearing request is dated January 9, 2008, but that appears to be a typographical
error as the request itself references the alleged receipt of the notice in November 2008.
7, in support of his motion. Petitioner filed six exhibits which he identified as P. Ex. 1 —
P. Ex. 6. Additionally, Petitioner filed three declarations consisting of declarations
signed by Petitioner on March 28 and April 17, 2009, and a declaration signed by his
wife. I identify Petitioner’s March 28, 2009 declaration as P. Ex. 7, his April 17, 2009
declaration as P. Ex. 8, and his wife’s declaration as P. Ex. 9. I receive all of these
exhibits into the record.

IL. Issue, findings of fact and conclusions of law
A. Issue

The single issue that I hear and decide in this case is whether I must dismiss Petitioner’s
hearing request.

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. I must dismiss a hearing request that is not timely filed.

Hearings in cases involving the I.G. are governed by regulations at 42 C.F.R. Part 1005.
These regulations provide that an individual who is the subject of an adverse
determination by the I.G. is entitled to a hearing before an administrative law judge, only
if he or she files a hearing request within 60 days after receiving notice of the LG.’s
determination. 42 C.F.R. § 1005.2(c). The date of receipt of the notice is presumed to be
five days after the date of the notice absent proof to the contrary by the individual who is
the addressee. Jd.

The regulations direct an administrative law judge to dismiss any hearing request that is
untimely filed by stating that the judge “will” dismiss any untimely request. 42 C.F.R.
§ 1005.2(e)(1). An administrative law judge has no discretion to grant a hearing in the
case where the hearing request is untimely.

2. Petitioner did not overcome the presumption that he received the
I.G.’s notice 65 days after it was mailed to him.

It is undisputed that the I.G. mailed a notice of exclusion to Petitioner at what the I.G.
believed was Petitioner’s home address on September 28, 2001. Petitioner is presumed
to have received that notice within five days of its mailing, or by October 3, 2001. Any
hearing request filed by him more than 60 days after October 3, 2001 is presumptively
untimely. Petitioner’s hearing request, which he filed more than seven years after the
1.G. mailed his notice of exclusion to Petitioner, is therefore, presumptively late and I
must dismiss that request unless Petitioner provides proof overcoming the presumption of
an untimely request.

Petitioner asserts that he did not receive the I.G.’s 2001 notice. Petitioner contends that
the I.G. sent the notice to a residence which Petitioner had sold and moved from
approximately eight months prior to the date when the notice was mailed. Petitioner’s
brief in opposition to the I.G.’s motion at 1; P. Ex. 1-P. Ex. 3. According to Petitioner, he
did not learn of the I.G.’s exclusion determination until “I was working with counsel to
obtain restoration of my license as a pharmacist.” P. Ex. 7, at 2. Petitioner gives no date
as to precisely when that event occurred but asserts that his attorney did not receive an
actual copy of the exclusion notice until after November 19, 2008. Jd.

There is no reason for me to doubt Petitioner’s contention that he had sold his residence
and moved away from it months prior to the date when the I.G. mailed his exclusion
notice to that address. However, the fact that Petitioner had sold his residence and moved
by the time that the I.G. mailed the exclusion notice is not, in and of itself, sufficient to
overcome the presumption of delivery. Petitioner has not explained why the notice
would not have been forwarded to him by the United States Postal Service. The LG.
never received a return from the Postal Service stating that the notice was returned as
undelivered. I.G. Ex. 5, at 2. The reasonable inference that I draw from this is that the
notice was forwarded in the normal course of business to Petitioner’s new residence.
Even if forwarding did not take place for several weeks after the September 28, 2001
notice was mailed it is entirely reasonable that I infer that Petitioner’s hearing request,
filed by him more than seven years later, was untimely.

Moreover, the evidence produced by the I.G. shows that Petitioner actually received the
September 28, 2001 notice from two sources, directly from the I.G., but also via his then-
attorney.

The L.G. is not required to send an exclusion notice to an individual at that individual’s
home address. The regulation governing sending of notices requires that a notice be sent
by the LG. to an affected individual or entity but it does not direct specifically where the
notice must be sent. Notice is effective so long as the notice is ultimately received by the
affected individual or entity. The governing regulation provides that:

[I]f the I.G. determines that the exclusion is warranted, it will send a written
notice of this decision to the affected individual or entity.

42 C.F.R. § 1001.2002(a). Where the notice is sent or through whom is irrelevant so long
as the affected individual ultimately receives it. Thus, the regulation permits the I.G. to
send notice to an affected individual or entity via that individual’s or entity’s
representative or attorney. Indeed, in the case of a corporation or business entity other
than an individual, it would generally be impractical to send the notice to anyone other
than an agent or representative of that entity.

I conclude that Petitioner actually received the September 28, 2001 notice twice, via a
copy sent to his former residence by the I.G. and forwarded to him, but also via a copy
that was sent to his then-attorney. The LG. not only sent the September 28, 2001 notice
to Petitioner at what he thought was Petitioner’s home address but he sent another copy
of the notice to Petitioner via Alexander Bateman, Esq., the attorney who was
representing him at that time. I.G. Ex. 1, at 2; 1.G. Ex. 6-LG. Ex.7. It is reasonable that I
infer that Petitioner’s attorney communicated the September 28, 2001 notice to Petitioner
more or less contemporaneously with his receipt of that document.

Petitioner asserts that he never received a copy of the notice from his then-attorney. In
fact, according to Petitioner, by July 2001, before the I.G. sent his notice letter to
Petitioner and Mr. Bateman, Petitioner’s relationship with Mr. Bateman had deteriorated
to the point where his attorney was no longer communicating with him. As proof for this
assertion of non-communication, Petitioner offers a copy of a civil lawsuit for unpaid
legal fees filed in January 2004 against Petitioner by Mr. Bateman’s law firm. P. Ex. 6.

I find not to be credible Petitioner’s assertion that he no longer had a relationship with
Mr. Bateman as of September 28, 2001, when the I.G. sent his notice to Petitioner via Mr.
Bateman. Nor do I find to be credible Petitioner’s contention that Mr. Bateman never
forwarded to him the I.G.’s notice of exclusion. The evidence offered by the parties —
including evidence offered by Petitioner — shows that Mr. Bateman was still representing
Petitioner as of September 28, 2001. The civil complaint filed by Mr. Bateman’s firm
against Petitioner states that it represented him until November 2001, several weeks after
the I.G. sent the notice letter to Petitioner and Mr. Bateman. P. Ex. 6, at 4. It is true that
elsewhere the complaint seeks damages for services provided only through June 2001.
But, the fact that the law firm did not sue for services provided after June is not
inconsistent with a continuing attorney-client relationship for several months after that
date.

Furthermore the I.G. produced evidence that Mr. Bateman represented Petitioner until at
least October 2001. On October 10, 2001 the Office of Professional Discipline of the
State Education Department/The University of the State of New York sent to Petitioner a
notice of action concerning Petitioner’s pharmacy license with a copy to Mr. Bateman.
1G. Ex. 7, at 1. The inference that I draw from this document is that Mr. Bateman
continued to represent Petitioner as of October 10, 2001, a date after the mailing of the
1.G.’s September 28, 2001 notice.

3. I dismiss Petitioner’s hearing request because he did not file it timely.

The facts support my conclusion that Petitioner did not file a hearing request within 60
days of his having received the I.G.’s notice of his exclusion. Consequently, I must
dismiss Petitioner’s request.

/s/
Steven T. Kessel
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
)
TEHC, LLC, ) Date: April 14, 2009

(CCN: 10-7790), )
)
Petitioner, )
)

-V.- ) Docket No. C-08-719

) Decision No. CR1941
Centers for Medicare & Medicaid )
Services. )
)

DECISION

Petitioner, TEHC, LLC (Petitioner or TEHC), is a home health agency (HHA) located in
Fort Lauderdale, Florida. Until its termination on August 6, 2008, TEHC was certified to
participate in the Medicare program. Following a survey completed May 8, 2008, the
Centers for Medicare and Medicaid Services (CMS) terminated TEHC’s program
participation because it failed to maintain substantial compliance with five conditions of
participation. Petitioner here challenges its termination, and CMS moves for summary
judgment.'

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

' With its motion CMS filed a brief (CMS Br.) and eight proposed exhibits (CMS Exs.
1-8). Petitioner has filed a response (P. Response), brief (P. Br.) and ten proposed
exhibits (P. Exs. 1-10).
Discussion

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

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

An HHA is a public agency or private organization that “is primarily engaged in
providing skilled nursing services and other therapeutic services” to patients in their
homes. Social Security Act (Act) section 1861(0). It may participate in the Medicare
program as a provider of services if it meets that statutory definition and complies with
certain requirements, called conditions of participation. Act, sections 1861(0), 1891; 42
C.F.R. Part 484; 42 C.F.R. § 488.3. On the other hand, CMS, acting on behalf of the
Secretary of Health and Human Services, may terminate a provider agreement based on
the provider’s failure to comply with provisions of section 1861 or the regulations
governing its program participation. Act, section 1866(b)(2); 42 C.F.R. § 489.53(a)(1).

Here, on May 8, 2008, the Florida Agency for Health Care Administration (State
Agency) completed a recertification survey. CMS Ex. 1. Based on the survey findings,
CMS determined that TEHC was not in substantial compliance with five conditions: 42
C.F.R. § 484.10 (patient rights); 42 C.F.R. § 484.18 (acceptance of patients, plan of care,
and medical supervision); 42 C.F.R. § 484.30 (skilled nursing services); 42 C.F.R. §
484.48 (clinical records); and 42 C.F.R. § 484.55 (comprehensive assessment of
patients).

Petitioner has not challenged the May 2008 survey findings. Its hearing request focuses
solely on the HHA’s efforts to complete and submit an acceptable plan of correction and
to make “substantial changes to its operation in order to comply with federal
requirements.” CMS Ex. 7; see also, P. Ex. 8 (Nord Decl.).

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

> My findings of fact and conclusions of law are set forth, in italics and in bold, in the
discussion captions.
irrelevant to the facility’s appeal of [CMS’s] determination to terminate.” Carmel, DAB
No. 1584, at 13.°

The Board in Carmel noted that a provider’s participation is determined by means of a
state survey. Inasmuch as a facility entering the program may participate no earlier than
the date on which the onsite survey establishes compliance (42 C.F.R. § 489.13(a)), its
participation is terminated based on the findings at the time of the survey. The
regulations require CMS to rely on the survey agency’s finding which “necessarily relate
to the status of the facility as of the date of the survey.” The Board also pointed out that,
as a practical matter, relying on a date after the survey “could cause a never-ending cycle
of resurveys based on unsubstantiated claims of compliance by a facility as of the later
date.” Carmel, DAB No. 1584, at 13.

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

B. Petitioner is not entitled to an opportunity to correct.

In reaching this decision, I recognize CMS’s discretion to afford providers an opportunity
to correct deficiencies prior to termination. See, 42 C.F.R. § 488.28 (A deficient provider
may continue to participate only if the facility has “submitted an acceptable plan of
correction for achieving compliance within a reasonable time.”) Here, CMS afforded
Petitioner such an opportunity. However, because CMS is not required to afford a
provider the opportunity to correct a condition-level deficiency before terminating its
program participation, Petitioner’s claims to have submitted an acceptable plan of
correction are simply irrelevant.’ See, Community Home Health, DAB No. 2134, at 14
(2007); Excelsior Health Care Services, Inc., DAB No. 1529, at 6-7 (1995).

Finally, I note that, although Petitioner submitted two plans of correction (a plan and a
revised plan), CMS rejected the first as unacceptable and the second (submitted the day
after termination) as untimely, so TEHC was not afforded a follow-up survey. CMS Exs.
2, 4, 5. Petitioner bases this appeal on CMS’s refusal to accept its revised plan of

> Carmel involved a long-term care facility (SNF/NF), whose governing rules are not
completely identical to those of other providers (compare, e.g. 42 C.F.R. § 488.28 with
42 C.F.R. § 488.402). However, as I explained in an earlier decision, the Board based its
conclusions on rules applicable to all providers. Therapy Management Services, Inc.
d/b/a CompRehab, DAB CR1892, at 4-5 (2009).

+ T note that Petitioner has not even alleged that it achieved substantial compliance prior
to the termination date; it only claims to have submitted a corrective action plan that
CMS should have considered. P. Br. at 5.
correction. But, notwithstanding the considerable time the parties have dedicated to the
merits of CMS’s determination to reject TEHC’s revised plan, that determination is
wholly within CMS’s discretion and I simply have no authority to review it.

A provider dissatisfied with an initial determination — which includes the termination of a
provider agreement in accordance with section 489.53 — may request a hearing, and
hearings are conducted in accordance with procedures set forth in 42 C.F.R. Part 498. 42
C.F.R. §§ 498.5, 489.53(e). Only initial determinations are appealable. The regulations
list actions that are initial determinations and thus subject to appeal. The determination
to reject a provider’s plan of correction is not listed as an initial determination and is
therefore not reviewable in this forum. 42 C.F.R. § 498.3(b); On-Call Nursing of Alaska,
DAB CR1142, at 3-4 (2004); see also, HRT Laboratory, DAB No. 2118, at 11 (2007)
(same reasoning applied to a clinical laboratory); Hermina Traeye Memorial Nursing
Home, DAB No. 1810, at 13 (2002) (In affirming the termination of a SNF, “ALJ
properly concluded that he lacked authority to adjudicate the question of whether [CMS]
abused its discretion in deciding to reject the POC.”)

Conclusion

Because no one disputes that, at the time of its May 2008 survey, TEHC was not in
substantial compliance with Medicare conditions of participation, CMS was authorized to
terminate its provider agreement. I therefore grant CMS’s motion for summary
judgment.

/s/
Carolyn Cozad Hughes
Administrative Law Judge