Lakeridge Villa Health Care Center v. Leavitt

NOT RECOMMENDED FOR FULL-TEXT PUBLICATION
File Name: 06a0809n.06
Filed: November 3, 2006
No. 05-4194
UNITED STATES COURT OF APPEALS
FOR THE SIXTH CIRCUIT
LAKERIDGE VILLA HEALTH CARE )
CENTER, )
)
Petitioner-Appellant, )
) ON APPEAL FROM THE
v. ) DEPARTMENTAL APPEALS BOARD
) OF THE UNITED STATES
MIKE LEAVITT, Secretary, United ) DEPARTMENT OF HEALTH AND
States Department of Health and Human ) HUMAN SERVICES
Services; UNITED STATES )
DEPARTMENT OF HEALTH AND )
HUMAN SERVICES, )
Respondent-Appellee.
Before: GIBBONS and MCKEAGUE, Circuit Judges; FORESTER, District Judge.*
JULIA SMITH GIBBONS, Circuit Judge. Petitioner Lakeridge Villa Health Center
(“Lakeridge”) is an Ohio specialized nursing care facility that participates in the Medicare and
Medicaid programs under an agreement with respondent, the Secretary of Health and Human
Services (“Secretary”). As a participant in the federal programs, Lakeridge is required to be in
substantial compliance with federal requirements for skilled nursing homes (“provider
*
The Honorable Karl S. Forester, Senior United States District Judge for the Eastern
District of Kentucky, sitting by designation.
1
requirements”). The Ohio Department of Health (“ODH”) surveyed Lakeridge on behalf of the
Centers for Medicare and Medicaid Services (“CMS”) and found that Lakeridge was not in
substantial compliance with several provider requirements. CMS imposed a civil monetary penalty
(“CMP”) against Lakeridge in the amount of $80,300. An administrative law judge (“ALJ”) upheld
the CMP and, on appeal, the Departmental Appeals Board of the Department of Health and Human
Services (“DAB”) upheld the decision of the ALJ. Lakeridge appealed the DAB decision. Because
substantial evidence supports the DAB’s decision, we affirm.
I.
As a skilled nursing service provider, Lakeridge receives federal payments in accordance with
its provider agreement with the Secretary. 42 U.S.C. § 1395i-3. As part of the Medicare system,
Lakeridge must substantially comply with provider requirements for such nursing facilities as
described in the Social Security Act. 42 U.S.C. § 1395i-3(a)-(d); 42 C.F.R. §§ 483.1-483.75
(identifying provider requirements). State health agencies, acting by agreement with the Secretary,
conduct surveys of participating nursing facilities to monitor their compliance with provider
requirements. 42 C.F.R. § 488.305. Deficiencies identified during such surveys subject the facility
to a range of enforcement actions, including the imposition of a CMP of up to $10,000 per day of
violation, depending on the seriousness of the offense. 42 U.S.C. § 1395i-3(h)(2)(B)(ii). The
Secretary has clarified that “deficiencies constituting immediate jeopardy” are eligible for penalties
ranging between $3,050 and $10,000 per day, while “deficiencies that do not constitute immediate
jeopardy, but either caused actual harm, or caused no actual harm, but have the potential for more
than minimal harm” are eligible for fines ranging between $50 and $3,000 per day of violation. 42
C.F.R. § 488.438(a)(i)-(ii). CMPs begin on the date that the Secretary finds that the facility became
2
out of compliance and end when the facility has achieved substantial compliance. Id. § 488.440.
The following facts are not in dispute. On August 27, 1999, ODH, a designated reviewing
state agency, completed a standard survey1 at Lakeridge. ODH identified violations of five provider
requirements of sufficient seriousness to warrant a CMP, including one violation of 42 C.F.R. §
483.25(h)(2), creating immediate jeopardy, and violations of 42 C.F.R. §§ 483.13, 483.25,
483.25(c), and 483.25(d)(2), not producing immediate jeopardy.2 On October 8, 1999, ODH
completed a revisit survey. As a result of this survey, Lakeridge was determined to be in substantial
compliance with the provider requirements as of October 3, 1999. CMS imposed a fine on
Lakeridge in the amount of $5,150 per day from August 23, 1999 to August 30, 1999 and $1,150 per
day from August 31, 1999 until October 3, 1999, for a total of $80,300. Lakeridge timely requested
a hearing, which occurred over three days before an ALJ. CMS presented testimony by four state
surveyors, including three registered nurses and a registered dietician, and Lakeridge presented
testimony from one licensed practical nurse in its employ. The ALJ found that Lakeridge was not
in substantial compliance with respect to the asserted violations during the periods asserted and
upheld CMS’s imposition of a CMP. On appeal, the DAB upheld the ALJ’s determination.
II.
This court’s review of the DAB’s imposition of a CMP is “highly deferential.” Woodstock
Care Ctr. v. Thompson, 363 F.3d 583, 588 (6th Cir. 2003). “The findings of the Secretary with
1
A standard survey is “a periodic, resident-centered inspection which gathers information
about the quality of service furnished in a facility to determine compliance with the requirements
for participation.” 42 C.F.R. § 488.301.
2
CMS also presented evidence of a deficiency under 42 C.F.R. § 483.20(b), but the ALJ
determined Lakeridge was in substantial compliance with this section.
3
respect to questions of fact, if supported by substantial evidence on the record considered as a whole,
shall be conclusive.” Id. (quoting 42 U.S.C. § 1320a-7a). Substantial evidence is “such relevant
evidence as a reasonable mind might accept as adequate to support a conclusion.” Myers v. Sec’y
of Health & Human Servs., 893 F.2d 840, 842 (6th Cir. 1990) (quoting Richardson v. Perales, 402
U.S. 389, 401 (1971)). As to questions of law, significant deference is accorded to the agency’s
interpretation of its own regulations, and such an interpretation will be overturned only if it is
“arbitrary, capricious, an abuse of discretion or otherwise not in accordance with law.” St. Francis
Health Care Ctr. v. Shalala, 205 F.3d 937, 943 (6th Cir. 2000) (citation and quotation marks
omitted). The court “do[es] not consider the case de novo, nor resolve conflicts in the evidence, nor
resolve questions of credibility.” MeadowWood Nursing Home v. United States Dep’t of Health &
Human Servs., 364 F.3d 786, 788 (6th Cir. 2004) (internal citation and quotation marks omitted).
A.
Lakeridge first contends that both the ALJ and the DAB applied an incorrect standard of
review in this case “by placing the burden of persuasion on the facility” under Hillman
Rehabilitation Center, DAB No. 1611 (1997), available at 1997 WL 123708. Hillman’s burden-
shifting framework applies only when the evidence is in equipoise. Batavia Nursing & Convalescent
Ctr. v. Thompson, 143 F. App’x 664, 665 (6th Cir. 2005) (citing Fairfax Nursing Home, Inc. v.
United States Dep’t of Health & Human Servs., 300 F.3d 835, 840 n.4 (7th Cir. 2002)). The
evidence in this case is not in equipoise. As a result, Hillman does not apply, and the panel need not
address the validity of the Hillman standard.3
3
Counsel for Lakeridge has raised an identical challenge to Hillman at least five times on
behalf of different clients. See Harmony Court v. Leavitt, No. 05-3644, 2006 WL 2188705, at
*1 (6th Cir. Aug. 1, 2006); Ivy Woods Healthcare & Rehab. Ctr. v. Thompson, 156 F. App’x 775,
4
B.
Lakeridge proceeds to offer evidence purporting to counter the findings of deficiency made
by the CMS and upheld by the DAB. Although we are not obliged to review every violation, we
outline the findings of the DAB to demonstrate the substantial evidence supporting the imposition
of the CMPs.
1. 42 C.F.R § 483.25(h)(2)
Lakeridge’s most serious violation was based on 42 C.F.R. § 483.25(h)(2), which requires
facilities to provide adequate supervision and assistance devices to prevent accidents. The DAB
found that Lakeridge violated this regulation by attaching restraints to immovable objects in a
manner warned against by the restraint manufacturer and by not supervising residents who were thus
restrained. These failures created immediate jeopardy to six residents. Resident 30 has an impaired
cognitive status and a history of falling out of bed, and ODH observed her attempting to get out of
a bed with lowered side rails five times while restrained and unsupervised, thereby placing her at risk
of suffocation. ODH observed Resident 29 attempting to remove her restraint while unsupervised,
placing herself at risk of suffocation as a result, and Resident 8 attempting to get out of bed while
wearing a waist restraint and unsupervised while wearing the restraint, even after the ODH surveyor
informed the nursing staff of the resident’s attempt to leave the bed. Resident 22, like Resident 8,
778 (6th Cir. 2005); Sanctuary at Whispering Meadows v. Thompson, 151 F. App’x 386, 388-89
(6th Cir. 2005); Batavia Nursing & Convalescent Ctr. v. Thompson, 143 F. App’x 664, 665 (6th
Cir. 2005); Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App’x 181, 183-84 (6th
Cir. 2005). On each occasion, panels of this court have declined to entertain the claim for the
same reasons articulated in this opinion. The briefing on behalf of Lakeridge makes no mention,
however, of this argument’s lack of success before the Sixth Circuit. While we are mindful of
counsel’s wish to preserve this issue should there be a change in the law, we believe it incumbent
upon him to notify any future reviewing panels of the status of this argument in the Sixth Circuit.
See Thompson v. Parkes, 963 F.2d 885, 888 n.1 (6th Cir. 1992).
5
attempted to get out of bed while restrained and unsupervised. Resident 74 was incorrectly placed
in an improperly sized vest restraint, and ODH observed the resident become repeatedly suspended
by the restraint while unsupervised. Finally, Resident 73 was unsupervised while wearing a pelvic
restraint, contrary to the manufacturer’s instructions. The ALJ and DAB both found this evidence
sufficient to show immediate jeopardy to the restrained residents.
Lakeridge challenges the findings of deficiency as to each of these residents, but it does not
challenge the facts underlying the ALJ’s and the DAB’s holdings. Instead, Lakeridge asserts that
it was following a physician’s instructions in each case and makes unsubstantiated assertions that
its supervision was adequate. These arguments are unavailing. Not only does § 483.25(h)(2) not
address the justification for the use of restraints, but the ODH surveyors’ unchallenged observations
of residents attempting to get out of bed and becoming suspended are sufficient evidence to support
the DAB’s conclusion that Lakeridge’s supervision was inadequate. In addition, whether or not the
supervision was adequate, Lakeridge has not addressed CMS’s argument that the restraints were in
some cases incorrectly sized and secured.
Lakeridge also asserts that it cannot be cited for violating § 483.25(h)(2) because no actual
injury occurred; to hold otherwise, Lakeridge argues, would be to impose a strict liability standard.
Neither the regulation nor this court requires that actual harm occur for an immediate jeopardy
finding to be valid. Woodstock, 363 F.3d at 589-90; see also 42 C.F.R. § 488.301 (defining
“immediate jeopardy” as “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 added). This holding does not impose strict liability but rather
requires a nursing facility to take reasonable care to avoid accidents. As we have noted, the question
6
of whether a facility’s precautions are reasonable “is highly fact-bound and can only be answered
on the basis of expertise in nursing home management. As such, it is a question the resolution of
which we defer to the expert administrative agency, the HHS.” Woodstock, 363 F.3d at 589. Thus,
Lakeridge has provided no basis on which the panel could overrule the DAB’s conclusion that
Lakeridge violated 42 C.F.R. § 483.25(h)(2).
2. 42 C.F.R. § 483.13
The regulations guarantee nursing facility residents “the right to be free from any physical
or chemical restraints imposed for purposes of discipline or convenience, and not required to treat
the resident's medical symptoms.” 42 C.F.R. § 483.13(a). The DAB found that Lakeridge violated
this requirement with respect to at least four residents. Lakeridge’s sole argument is that this
determination is flawed because each restrained patient exhibited medical symptoms warranting the
use of restraints and because restraints were used upon a doctor’s orders.
This justification is unpersuasive. Even if the use of restraints on a patient is warranted for
a medical purpose, that use may not exceed the bounds established by § 483.13(a). As the DAB has
noted:
Because section 483.13(a) is directed towards nursing facilities, the regulation
imposes on the long-term care facility an independent obligation to ensure that the
use of restraints, even with a doctor's order, meets the criteria of the regulation.
Further, it imposes an independent obligation to continue to assess the impact of the
use of a restraint and to consult with the doctor if the nursing facility finds that use
of the restraint no longer meets the criteria of the regulation. Finally, review of a
facility's compliance requires careful consideration to make sure that the facility is
implementing the doctor's restraint order pursuant to its terms. Therefore, a long-term
care facility cannot rely solely on a doctor's order to prove compliance with section
483.13(a) and must be able to show with other evidence as appropriate that the
specific restraints applied were not imposed for discipline or convenience and were
necessary to treat a medical symptom.
7
Cross Creek Health Care Ctr., DAB No. 1665, at 11 (1998).
The record is replete with evidence supporting the DAB’s determination as to the manner in
which Lakeridge personnel utilized restraints. Although Lakeridge restrained Resident 29 on the
basis of a doctor’s order to immobilize the resident following a hip fracture, Lakeridge did not
reassess the need for restraints after the fracture healed in May 1999. The DAB also determined that
two patients were in pelvic restraints to a degree not supported by a physician’s orders. Resident 73
was to be released from her restraints after two hours, but was restrained for three hours during the
ODH survey. Similarly, Resident 62 was restrained for four consecutive hours, even though her
physician ordered that she be released after two hours.
Other than noting that each of these residents had symptoms that could support the use of
restraints, Lakeridge has not contested the evidence supporting the DAB’s findings for any of these
residents. The undisputed evidence is sufficient to support the DAB’s conclusion that Lakeridge
violated § 483.13(a) because Lakeridge used restraints, at a minimum, in ways not permitted by a
physician’s orders. There is substantial evidence to support the DAB’s conclusion that Lakeridge
violated § 483.13(a).
3. 42 C.F.R. § 483.25
The DAB upheld CMS’s citation of Lakeridge for violating the catchall provision, which
requires that “[e]ach resident . . . receive and the facility . . . provide the necessary care and services
to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in
accordance with the comprehensive assessment and plan of care.” 42 C.F.R. § 483.25.
The ALJ determined that Lakeridge violated § 483.25 with respect to several residents by not
providing care consistent with that provided for in the plan of care for each resident. Lakeridge does
8
not offer a challenge to the findings underlying the DAB’s decision as to §483.25. Instead, it
presents two arguments wholly unrelated to the evidence. It contends, first, that it is inappropriate
to cite the nursing facility under the general language of § 483.25 when the violations could have
been cited under a specific subsection. Second, it insists, generally, that no causal relationship exists
between the care administered by Lakeridge employees and the problems suffered by the residents.
Lakeridge’s first contention is without merit and exhibits a misunderstanding of the
deficiency; not only has Lakeridge failed to identify a specific subsection under which failure to
follow a plan of care would be appropriately addressed, but such identification would not be
dispositive. A single act can easily violate more than one provision, as did Lakeridge’s care for some
residents who developed pressure sores as a result of Lakeridge’s failure to follow a prescribed
standard of care. As the DAB stated, relying on Beechwood Sanatarium, DAB No. 1906 (2004),
“[t]he fact that CMS may have been able to cite a deficiency under another tag is irrelevant.” JA 75.4
Lakeridge’s causation argument is similarly unavailing. The issue of whether Lakeridge
followed the plan of care is logically independent from the health outcome of the care actually
delivered. Actual harm is not required for Lakeridge to violate the provider requirements. Nor does
the mere presence of adequate plans of care suffice; the ALJ did not determine that the plans of care
were insufficient but rather determined that Lakeridge failed to follow them.
4. 42 C.F.R. § 483.25(c)
Lakeridge next claims that the DAB wrongly upheld the CMP imposed for violation of
4
In fact, the regulations anticipate this eventuality; one of the factors to be considered in
assessing a fine is “the relationship of the one deficiency to other deficiencies resulting in
noncompliance.” 42 C.F.R. § 488.404(c)(1).
9
§ 483.25(c), which provides:
Based on the comprehensive assessment of a resident, the facility must ensure
that–
(1) A resident who enters the facility without pressure sores does not develop
pressure sores unless the individual's clinical condition demonstrates that they were
unavoidable; and
(2) A resident having pressure sores receives necessary treatment and services to
promote healing, prevent infection and prevent new sores from developing.
42 C.F.R. § 483.25(c). CMS claims that Lakeridge violated this subsection by allowing several
residents to develop pressure sores and by failing to provide necessary treatment of such sores.
The ALJ determined that Lakeridge failed to provide proper pressure sore care to four
residents. This decision is supported by substantial evidence as to each of the residents. Resident
24 suffered from a pressure sore that increased in size between August 17 and August 26, 1999.
The ODH surveyor noted that Resident 24 was left in a chair with no pressure-relieving device for
three hours and two hours on two separate occasions. The surveyor testified that the pressure sore
was exacerbated by these long periods without movement. The surveyor also noted that the sore was
not dressed, in contravention of a physician’s instruction, and that the wound was covered by a urine-
soaked incontinence brief while not dressed. The surveyor testified that this condition also
exacerbated the condition of the sore. This is sufficient evidence to support the ALJ’s determination
that Lakeridge failed to provide necessary care to promote healing and prevent infection of the sore.
The fact that Lakeridge’s plan of care included the application of an ointment to the area twice a day
and that no doctor noted any sores prior to the development of the sore on August 19, 1999 does not
change this conclusion. The ALJ could reasonably credit the surveyor’s testimony and determine
that Lakeridge was not providing necessary treatment despite the fact that Lakeridge provided some
10
treatment.
The ALJ’s conclusions as to the other residents is similarly supported by substantial
evidence. Resident 29 had a sore that increased in size, and the surveyor saw that feces were allowed
to come in contact with the wound. Like Resident 24, Resident 29 was restrained in a wheelchair
without a pressure-relieving device. Lakeridge defends its actions by claiming that no doctor ordered
the use of a pressure-relieving device. This is an insufficient argument: Lakeridge cannot fail to take
action based on its reliance on the lack of a prescribed course of action; Resident 29 had a sore, and
the regulation requires Lakeridge to use a pressure-relieving device whether or not prescribed.
Resident 9 exhibited several pressure sores. Like the preceding residents, he was left in his
wheelchair for an extended period without a pressure-relieving device. He was not toileted and was
allowed to sit in urine. The ALJ could properly determine that Resident 9 was not provided the
required standard of care to promote healing of the sores. This would be true even if the panel
accepted Lakeridge’s argument that the ALJ improperly relied on an abrasion of the resident’s skin
rather than on pressure sores. The evidence regarding the chair positioning and toileting of the
resident is sufficient to support the decision.
In sum, there is substantial evidence to support the DAB’s determination that Lakeridge
violated § 483.25(c).
5. 42 C.F.R. § 483.25(d)(2)
Finally, Lakeridge challenges the DAB’s conclusion as to its violation of § 483.25(d)(2),
which requires nursing facilities to ensure that “[a] resident who is incontinent of bladder receives
appropriate treatment and services to prevent urinary tract infections and to restore as much normal
bladder function as possible.” 42 C.F.R. § 483.25(d)(2).
11
As is the case for the other violations, substantial evidence supports the Secretary’s
conclusion that Lakeridge’s care violated § 483.25(d)(2). Resident 39 is a particularly egregious
example of Lakeridge’s failings in this area. According to the ALJ, the resident’s toileting program
was insufficient because it was to be used only three to five times per week. The facility failed to
provide toileting in advance of need as required by the care plan. The resident was transferred to her
bed after spending two hours in her chair during dinner without being offered toileting, the resident
soiled herself less than 45 minutes later, and the staff did not change the brief for an additional 45
minutes. Finally, the resident was left in a chair for three hours without an offer of toileting.
Lakeridge’s sole defense to this evidence is to claim that the patient refused treatment due to knee
pain. CMS rightly notes, however, that this claim is based on testimony as to Resident 31, not
Resident 39
The record reveals a number of similar deficiencies. Resident 31, who was left in bed
wearing a wet brief, knew when she needed to use the bathroom but was unable to find help at that
time. Resident 26 was not offered toileting after meals or at bedtime in violation of the plan of care.
Resident 30 was left for more than an hour wearing a soiled brief and was not cleaned when the brief
was changed. Resident 9 received assistance moving to the commode only upon the surveyor’s
prompting, and his soiled brief was replaced only after the resident successfully used the commode.
This is substantial evidence to support the Secretary’s finding.
C.
Finally, Lakeridge challenges the amount of the fine imposed by CMS.5 Lakeridge, however,
5
CMS claims that Lakeridge has not challenged the reasonableness of the CMP.
Lakeridge, however, has made a sufficient argument as to this point to require review of the
issue.
12
provides no reason why the fine is excessive. CMS imposed a fine well within the statutory range
for both the immediate-jeopardy violation and the non-immediate-jeopardy violations. In imposing
a CMP, CMS is required to consider (1) the facility’s history of noncompliance; (2) the facility’s
financial condition; (3) the facility’s degree of culpability; and (4) the factors listed in 42 C.F.R. §
488.404. 42 C.F.R. § 488.438(f). Section 404 allows CMS to consider the scope and severity of the
deficiencies and the relationship of one deficiency to other deficiencies resulting in noncompliance.
In this case, the ALJ analyzed the fines separately for each jeopardy category. In upholding
the CMP as to the immediate-jeopardy violation, the ALJ considered: (1) the severity of the
violation; (2) the broad scope of the violation, which affected six separate residents; (3) Lakeridge’s
poor compliance history; and (4) Lakeridge’s culpability, because its staff appeared indifferent to the
plight of its residents. As to the violations not creating immediate jeopardy, the ALJ considered (1)
scope, both as to the large numbers of affected residents and the number of separate types of
violation; (2) severity, because several residents suffered actual harm from the violations; and (3)
Lakeridge’s prior history of violations, especially as to pressure sores. The ALJ adequately
considered the required factors to satisfy any procedural reasonableness claim and reached a
reasonable conclusion as to the amount of the CMP.6
III.
For the reasons outlined above, we affirm the decision of the Departmental Appeals Board.
6
Lakeridge also argues that CMS may not assess a fine while the facility is implementing
a plan of correction. Lakeridge points to no authority, however, within the statute or the
applicable regulations to support the proposition that the adoption of a corrective plan by a care
provider effects a stay of penalties upon the adoption and execution of a corrective plan. Rather,
the regulations state that per-day civil money penalties are computed and collectible “for the
number of days of noncompliance until the date the facility achieves substantial compliance . . .
.” 42 C.F.R.§ 488.440(b).
13