Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
)

St. Michael’s Nursing Center ) Date: November 25, 2009
(CCN: 23-5610), )
)
Petitioner, )
)

-V.- ) Docket No. C-09-75
) Decision No. CR2038
Centers for Medicare & Medicaid )
Services. )
)
DECISION

Petitioner, St. Michael’s Nursing Center (Petitioner or facility), is a long-term

care facility located in Detroit, Michigan, that, until recently, participated in the Medicare
program. The Centers for Medicare & Medicaid Services (CMS) determined that the
facility was not in substantial compliance with Medicare requirements and has imposed
penalties: denial of payment for new admissions (DPNA) and termination. Petitioner
here challenges CMS’s determinations, and CMS has moved for summary judgment.

For the reasons set forth below, I find that the facility was not in substantial compliance
with Medicare program requirements. CMS may therefore impose remedies, including
those imposed here. I have no authority to review its determination to do so, nor its
selection of remedies.

I. Background

The Social Security Act (Act) sets forth requirements for nursing facility participation in
the Medicare program, and authorizes the Secretary of Health and Human Services to
promulgate regulations implementing those statutory provisions. Act § 1819. The
Secretary’s regulations are found at 42 C.F.R. Part 483. To participate in the Medicare
program, a nursing facility must maintain substantial compliance with program
requirements. To be in substantial compliance, a facility’s deficiencies may pose no
greater risk to resident health and safety than “the potential for causing minimal harm.”
42 CFR. § 488.301.

The Secretary contracts with state survey agencies to conduct periodic surveys to
determine whether skilled nursing facilities are in substantial compliance. Act § 1864(a);
42 C.F.R. § 488.20. The regulations require that each facility be surveyed once every 12
months, and more often, if necessary, to ensure that identified deficiencies are corrected.
Act § 1819(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308.

Here, following a complaint investigation survey, completed July 23, 2008, CMS
determined that the facility was not in substantial compliance with a multitude of
Medicare participation requirements, two of which it determined posed immediate
jeopardy to resident health and safety. Specifically, CMS found that the facility was not
in substantial compliance with the following regulations:

© 42C.F.R. § 483.13(a) (Tag F221 — physical restraints) at a D level of scope and
severity (isolated instance of noncompliance that causes no actual harm with the
potential for more than minimal harm);

© 42 C.F.R. § 483.13(c)(1)(ii)-(iii), (c)(2)-(4) (Tag F225 — staff treatment of
residents) at a D level of scope and severity;

© 42 C.F.R. §§ 483.20(d) and 483.20(k)(1) (Tag F279 — comprehensive care plans)
at a D level of scope and severity;

© 42C.F.R. § 483.25 (Tag F309 — quality of care) at a G level of scope and severity
(isolated instance of noncompliance that causes actual harm that is not immediate
jeopardy);

e 42C.F.R. § 483.25(c) (Tag F314 — pressure sores) at the immediate jeopardy level
of scope and severity);

© 42 C.F.R. § 483.25(h) (Tag F323 — accidents and supervision) at a G level of
scope and severity;

© 42C.F.R. § 483.25(k) (Tag F328 — special needs) at the immediate jeopardy level;
© 42C.F.R. § 483.30(a) (Tag F353 — nursing services) at an H level of scope and

severity (pattern of noncompliance that causes actual harm that is not immediate
jeopardy);
© 42C.F.R. § 483.65(a) (Tag F441 — infection control) at an F level of scope and
severity (widespread noncompliance that causes no actual harm with the potential
for more than minimal harm);

© 42 C.F.R. § 483.70 (Tag F454 — physical environment) at an E level of scope and
severity (pattern of noncompliance that causes no actual harm with the potential
for more than minimal harm);

© 42C.F.R. § 483.75 (Tag F490 — administration) at an F level of scope and
severity;

e 42C.F.R. § 483.75(e)(8) (Tag F497 — regular in-service education) at an E level of
scope and severity;

e 42 C.F.R. § 483.75(j)(1) (Tag F502 — laboratory services) at an E level of scope
and severity;

e 42 C.F.R. § 483.75(1)(1) (Tag F514 — clinical records) at a D level of scope and
severity.

CMS Exs. 1, 2.

Based on these findings, CMS denied the facility payment for its new admissions,
effective August 30, 2008, and terminated the facility’s Medicare/Medicaid provider
agreement, effective October 3, 2008. CMS Ex. 2, at 2.

Petitioner timely requested a hearing.

CMS moves for summary affirmance, arguing that undisputed evidence establishes that
the facility was not in substantial compliance with 42 C.F.R. §§ 483.25(h) (accidents and
supervision), 483.25(k) (special needs), 483.75(e)(8) (regular in-service education), and
483.75(j)(1) (laboratory services). CMS argues that, as a matter of law, it may impose
remedies based on the facility’s failure to comply substantially with any one of these
regulations.

Petitioner has not disputed CMS’s argument that it may impose these penalties when a
facility is not in substantial compliance with program requirements. However, Petitioner
opposes CMS’s motion, arguing that, for each of these deficiencies, genuine issues of
material fact preclude the entry of summary judgment.
The parties have filed memoranda in support of their positions (CMS Br.; P. Br.). CMS
has submitted 14 exhibits (CMS Exs. 1-14). Petitioner has submitted 13 exhibits,
numbered P. Exs. 1-6 and P. Exs. 11-17 (P. Exs. 7-10 were not submitted).

IL. Issues
I consider whether summary judgment is appropriate.

On the merits, the sole issue before me is whether the facility was in substantial
compliance with program requirements. As discussed below, if the facility is not in
substantial compliance, CMS may impose a remedy, including those remedies imposed
here (denial of payment for new admissions and termination).

II. Discussion

Summary Judgment. Summary judgment is appropriate if a case presents no genuine
issue of material fact, and the moving party is entitled to judgment as a matter of law.
Illinois Knights Templar Home, DAB No. 2274, at 3-4 (2009), and cases cited therein.

The moving party may show the absence of a genuine factual dispute by presenting
evidence so one-sided that it must prevail as a matter of law, or by showing that the non-
moving party has presented no evidence “sufficient to establish the existence of an
element essential to [that party’s] case, and on which [that party] will bear the burden of
proof at trial.” Livingston Care Center v. Dep’t of Health & Human Services, 388 F.3d
168, 173 (6th Cir. 2004) (quoting Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986)).
To avoid summary judgment, the non-moving party must then act affirmatively by
tendering evidence of specific facts showing that a dispute exists. Matsushita Elec.
Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586 n.11 (1986); see also Vandalia Park,
DAB No. 1939 (2004); Lebanon Nursing and Rehabilitation Center, DAB No. 1918
(2004).

To defeat an adequately supported summary judgment motion, the non-
moving party may not rely on the denials in its pleadings or briefs, but must
furnish evidence of a dispute concerning a material fact... .

Illinois Knights Templar at 4; Livingston Care Center, DAB No. 1871, at 5 (2003).

In examining the evidence for purposes of determining the appropriateness of summary
judgment, I must draw all reasonable inferences in the light most favorable to the non-
moving party. Brightview Care Center, DAB No. 2132, at 2, 9 (2007); Livingston Care
Center, 388 F.3d at 172; Guardian Health Care Center, DAB No. 1943, at 8 (2004); but
see Brightview, DAB No. 2132, at 10 (entry of summary judgment upheld where
inferences and views of non-moving party are not reasonable). Moreover, drawing
factual inferences in the light most favorable to the non-moving party does not require
that I accept the non-moving party’s legal conclusions. Cf: Guardian Health Care
Center, DAB No. 1943, at 11 (“A dispute over the conclusion to be drawn from applying
relevant legal criteria to undisputed facts does not preclude summary judgment if the
record is sufficiently developed and there is only one reasonable conclusion that can be
drawn from those facts.”).

A, CMS is entitled to summary judgment because the undisputed facts
establish that the facility was not in substantial compliance with 42
CF.R. § 483.25(h); it did not ensure that the resident environment
remained as free of accident hazards as possible and did not ensure that
each resident received supervision and assistance devices necessary to
prevent accidents.’

Under the statute and the “quality of care” regulation, each resident must receive, and the
facility must provide, the necessary care and services to allow a resident to attain or
maintain the highest practicable physical, mental, and psychosocial well-being, in
accordance with the resident’s comprehensive assessment and plan of care. Act

§ 1819(b); 42 C.F.R. § 483.25. The regulation also requires that the facility “ensure” that
the resident’s environment remains as free of accident hazards as is possible. It must
“take reasonable steps to ensure that a resident receives [the] supervision and assistance
devices designed to meet his assessed needs and to mitigate foreseeable risks of harm
from accidents.” Guardian Health Care Center, DAB No. 1943, at 18 (2004) (citing 42
C.F.R. § 483.25(h)(2)); Briarwood Nursing Center, DAB No. 2115, at 5 (2007). The
facility must anticipate what accidents might befall a resident and take steps to prevent
them. A facility is permitted the flexibility to choose the methods it uses to prevent
accidents, but the chosen methods must constitute an “adequate” level of supervision
under all the circumstances. Briarwood at 5; Windsor Health Care Center, DAB No.
1902, at 5 (2003).

Resident 513 (R513). R513 was a 54-year-old man suffering from end-stage renal
disease, anasarca (massive edema), dementia, bi-polar disorder, and other maladies.
CMS Ex. 6, at 8. Although described as alert and oriented to name and place, he was
often forgetful and confused. He had a history of behavioral problems, was verbally and
physically abusive, and resisted care. CMS Ex. 6, at 18.

' My findings of fact/conclusions of law are set forth, in italics and bold, in the
discussion captions of this decision.
At least as early as November 2007,’ the facility recognized that R513 was at risk for
injury from falls, and set as a goal “no incident of falls, accident, trauma, or injury” for
90 days. Among the approaches listed in his care plan were to “maintain hazard free
environment,” “do initial fall risk assessment and up-date every 90 days,” and “institute
fall protocol.” CMS Ex. 6, at 29. Nothing in the record explains the “fall protocol.”

R513 nevertheless had a series of accidents, neither well-documented nor investigated,
that resulted in minor injuries. CMS Ex. 6 at 29 (on December 29, 2007, resident found
on the floor); CMS Ex. 6, at 10, (January 10, 2008 wrist injury); CMS Ex. 6, at 12, 13, 37
(February 19, 2008 “fall at dialysis” injuring head and arm). Except to note the incidents,
no changes were made to his care plan following these injuries. CMS Ex. 6, at 29.

R513 required regular hemodialysis, and the facility arranged his transportation to the
dialysis center. CMS Ex. 6, at 18. On February 28, 2008, the van driver charged with
taking R513 to dialysis left the resident unattended, his wheelchair on the van’s lift while
he (the driver) went to start the van. The resident flipped backward, hitting his head on
the concrete. The driver returned the bleeding resident to the facility, and he was
subsequently transferred to the hospital with a left occipital abrasion and hematoma, right
knee abrasion, and right rib pain. CMS Ex. 6, at 14-15, 18, 38, 134-149.

In response to this accident, facility staff told the driver never to leave residents
unattended. CMS Ex. 6, at 14.

Judging from its report of the incident, the facility’s investigation was perfunctory, at
best, offering few details, and, aside from instructing the driver not to leave residents
unattended, no suggestions for preventive measures. The report is also inaccurate.
Notwithstanding R513’s earlier falls (CMS Ex. 6, at 12, 13, 29, 37), it says that the
resident has had no recent falls or similar incidents. CMS Ex. 6 at 14-15.

Although his November 2007 care plan called for a fall risk assessment, I find no
evidence that facility staff performed one until March 19, 2008. Again, even though the
record documents multiple falls and multiple injuries from falls — including the very
significant incident of February 28 — R513’s March 19 fall risk assessment indicates zero
falls in the preceding three months. Even with this rather significant inaccuracy, R513
still scored 16 on the assessment, where a score of 10 or above represents high risk for
falls. CMS Ex. 6, at 34. And yet, no changes were made to his written care plan.

> It seems that R513 was admitted to the facility on November 9, 2007, transferred
to St. Johns Hospital on November 10, was readmitted to the facility on November 13,
transferred to St. Johns on February 28, 2008, and was readmitted to the facility on
March 19, 2008. CMS Ex. 6, at 8.
A physician order dated March 20 calls for pelvic restraint. CMS Ex. 6, at 66. A note
dated March 21, 2008 indicates that physical therapy staff evaluated R513’s tendency to
slide forward in his wheelchair, putting him at risk for falls. She recommended a
pommel cushion’ and “nursing to monitor.” CMS Ex. 6, at 41.

An assessment dated March 23, 2008, identifies R513 as at risk for falls related to his
“wandering in and out of other resident rooms,” his antidepressant and antianxiety
medications, and his “inability to ambulate great distances.” Curiously, and inexplicably,
the assessment again says that he “has had no falls noted.” CMS Ex. 6, at 28.

On April 4, 2008, the facility reported that R513’s left femur had been fractured,
although no one knew how or when the injury occurred. CMS Ex. 6, at 16,48. Ina
report dated April 11, 2008, the facility’s director of nursing (DON), Kafi Wilson, RN,
indicated that on March 27, 2008, R513 complained of discomfort and slight edema, but
x-rays of his left ankle, tibia, fibula and knee showed no fracture. See P. Ex. 14, at 1, 4,
5. A week later, after he complained of discomfort on his left side, x-rays of his left hip
and pelvis showed “slightly displaced intertrochanteric fracture” of left femur. See CMS
Ex. 6, at 94, 95, 96. He went to the hospital where he underwent surgery to repair the
fracture. CMS Ex. 6, at 111-114. According to DON Wilson, interviews with staff, the
resident, and his roommate “revealed resident had not sustained any recent falls, trauma
or injury since the occurrence on 2/28/08; however, he continued to attempt unassisted
transfers, ambulation, and resistance to care since that time.” She concluded that “aside
from the occurrence on 2/28/08, we are unable to substantiate how this fracture
occurred.” CMS Ex. 6, at 18-19; see CMS Ex. 6, at 20-25.

Staff apparently developed for R513 a new care plan, dated April 13, 2008, which refers
to the resident’s history of falls, and sets as goals to “identify the least restrictive and
most effective restraint,” and to minimize the use of restraints within 60 days. Among
other approaches, the plan calls for consultation with physical therapy staff “for restraint
evaluation,” releasing him from his restraints every two hours, and “frequent short
contacts with resident to assess needs.” CMS Ex. 6, at 31; P. Ex. 14, at 11. The call fora
physical therapy consult is puzzling because staff had a/ready consulted the physical
therapist, who had recommended a pommel cushion and nurse monitoring. CMS Ex. 6,
at 41. Yet the new care plan does not refer to that recommendation, and does not call for
a pommel cushion or any other new intervention. Further, nurses’ notes document that
the facility had been restraining R513 at least as early as January 2008, even though
restraints were not then incorporated into his care plan. CMS Ex. 6, at 35 (“resident
sitting in [wheelchair with] belt, restraint in place”); see also CMS Ex. 6, at 40 (March 20
telephone order for “pelvic restraint for maintain safety”).

> A pommel cushion is a seat cushion designed to provide seating stability.
On June 3, 2008, R513 was found on the floor of his room with a deep cut in his
forehead, and was again transferred to the hospital. Staff suggested obtaining an order
for a restraint, and a medication assessment, as well as placing him in a low bed to
prevent injury. CMS Ex. 6 at 26-27, 51-52, 98, 201-219. But, again, none of these
recommendations were added to his care plan.

Petitioner has not disputed any of these facts, but points to the declaration of Licensed
Practical Nurse (LPN) Peggye Jackson, a former nurse supervisor at the facility. LPN
Jackson provides absolutely no details regarding when, how, or why facility staff
implemented interventions to prevent R513 from falls, although she lists generally some
preventive measures that she says the facility took: wheelchair use, geri chair use,
pommel cushion to prevent sliding, pelvic restraint, and a low bed “when it was
appropriate.” She also notes that R513 was administered psychotropic medication to
control his agitation. P. Ex. 13 (Jackson Decl.).

l accept that, at some time, the facility implemented each of these measures;* however, it
does not follow that the facility was therefore ensuring an environment as free of accident
hazards as possible, or that it was adequately supervising R513. First, not one of the
interventions mentioned by LPN Jackson was incorporated into R513’s care plan. In
fact, the written care plan seems geared toward improving a resident’s ability to stand and
walk (assess and assist with posture and gait, provide proper shoes, exercise extremities,
mop up spills and remove clutter, encourage balance and exercise for long distance
ambulations). In contrast, the interventions described by LPN Jackson seem designed for
an individual who is unable to stand and walk safely, and must be restrained in a chair.
Similarly, DON Wilson’s April 4, 2008 accident report suggests that R513’s accidents
were caused by his unassisted transfers, ambulation, and resistance to care. CMS Ex. 6 at
18-19.

If DON Wilson’s opinion as to the causes of R513’s falls was correct, and the
interventions described by LPN Jackson were the more appropriate, those problems and
interventions should have been incorporated into R513’s care plan after a comprehensive
assessment had been performed. Ad hoc measures do not satisfy the regulation, which
requires that care and services be provided “in accordance with the comprehensive
assessment and plan of care.” 42 C.F.R. § 483.25.°

* For example, staff initially suggested a low bed in June 2008. I accept that he
was eventually provided such a bed, although the record is silent as to when.

* Notwithstanding DON Wilson’s report, LPN Jackson’s declaration, and R513’s
medical records, Petitioner suggests that R513 ambulation was improving, because he
was “actually receiving physical therapy.” In a remarkable and wholly unsupported
statement, Petitioner claims that “[i]t makes no sense that someone with a falls problem

(...continued)
The record here shows that from November 2007 until at least April 2008 (when staff
discovered his unexplained fracture) the facility’s principal response to R513’s accidents
was to ignore or deny them. For most of his injuries, the record shows no investigation.
For the more serious incidents, the facility reports only perfunctory investigations.

Although called for in his November 2007 care plan, I see no evidence of any fall risk
assessment until March 2008, four months later. CMS Ex. 6, at 34. And, to the extent
that facility staff were performing any such assessments, they did not accurately reflect
R513’s situation. In their assessments and investigations, staff repeatedly reported
erroneously that R513 had suffered no falls. CMS Ex. 6, at 14-15 (no recent falls or
similar incidents); CMS Ex. 6, at 34 (zero falls in preceding three months); CMS Ex. 6, at
28 (no falls noted). The facility thus did not even accurately describe the extent of the
resident’s problems. Such errors and inconsistencies show that the facility was not taking
reasonable steps to ensure the resident’s safety.

The facility should also have carefully investigated each of the accidents involving R513
and accurately re-assessed the resident’s condition. It should have developed approaches
reasonably related to the resident’s situation, and incorporated them into his care plan. It
then should have implemented those approaches, and documented their effectiveness.

Finally, Petitioner evidences an unacceptably narrow view of its responsibilities for
keeping the resident safe when it disavows any responsibility for R513’s February 28,
2008 fall, arguing that the fall was “due to the van driver’s negligence,” and
characterizing the responsible party as “a transportation company that was entirely
unrelated by ownership or control” to the facility. P. Br. at 28-29. According to
Petitioner, the van driver failed to secure the resident’s wheelchair, so it tipped back and
he fell and was injured. P. Br. at 28-29; P. Ex. 13 (Jackson Decl.) (“This resident[’]s fall
on 2/19/08 was strictly the negligence of the van driver leaving the resident at the edge of
the elevated ramp not anchored or strapped down.”) I agree that R513’s injuries were
likely the result of negligence on the part of his caregivers. However, I do not agree that

* (continued...)

would be receiving physical therapy if he was actually declining in that regard.” P. Br. at
29. In fact, the opposite is true. A resident whose condition is declining would more
likely be referred to physical therapy. As LPN Jackson asserts, R513 was receiving
physical therapy “to prevent further decline and try to maintain or improve his level of
functioning.” P. Ex. 13 (Jackson Decl.). Moreover, the physical therapy records describe
the resident’s decreasing strength, decreasing range of motion and decreasing functional
level. P. Ex. 14, at 15-21; CMS Ex. 6 at 56. For purposes of summary judgment, I need
not accept the unsupported assertions of counsel. In any event, whether R513’s ability to
walk was improving is not material to my resolution of this case.
10

the facility avoids responsibility by distancing itself, administratively, from the
transportation company engaged to convey its resident to the dialysis center.

Facilities frequently contract out services, but doing so does not relieve them of their
responsibility for the quality of those services. See 42 C.F.R. § 483.20(k)(3) (services
“arranged by the facility must . . . meet professional standards of quality’).

Moreover, as the Departmental Appeals Board ruled in Liberty Nursing and
Rehabilitation Center — Mecklenberg County, DAB No. 2095 (2007) and SunBridge Care
and Rehabilitation for Pembroke, DAB No. 2170 (2008), the regulatory term “resident
environment” must be construed broadly to protect the residents whose care the facility
has undertaken to provide. Liberty Nursing, DAB No. 2095, at 8; SunBridge, DAB No.
2170, at 28. Specifically applying this principle to transportation, the Board held that
“when a facility transports residents under its care in a van, the van is the resident
environment, and the regulations [483.25(h)] apply.” Liberty at 9; Sunbridge at 29.

Nor is the facility exempt here because it did not own the van service. In Eastwood
Convalescent Center, DAB No. 2088 (2007), the Board held the facility accountable for a
resident’s injuries where, with the knowledge and approval of the facility administrator,
the resident’s husband undertook to transport her back to the facility. Eastwood
Convalescent Center at 12-14.

Here, no one disputes that R513 was a seriously ill resident whose behavior problems and
resistance to care made him difficult to control. Yet, the facility sent him, unsupervised,
to hemodialysis, under the sole “care” of a van driver, without verifying that driver’s
competence or training to provide R513 the level of supervision he obviously required.
By itself, this practice establishes that the facility was not taking reasonable steps to
ensure the R513 received the supervision that he needed.

The parties dispute whether R513 was “acting out” when the accident occurred. Pointing
to statements from the van driver, CMS claims that he was. Despite having no actual
witness or other evidence to suggest otherwise, Petitioner denies that R513 was
displaying any behavior problems at the time of his accident. I could simply dismiss
Petitioner’s claims, since it has not come forward with evidence establishing a dispute of
fact. In any event, this purported dispute of fact is not material. Entrusting to the care of
a lone van driver an erratic and behaviorally-challenged resident, by itself, violates the
regulation.

R513 was not the only resident for whom the facility failed to provide necessary
supervision and assistance devices to mitigate foreseeable risks of harm from accidents.

Resident 515 (R515). At the time of the survey, R515 was a 45-year-old woman
suffering from bipolar disorder, seizure disorder and other impairments. CMS Ex. 7, at 6.
11

She apparently used a wheelchair, and the undisputed evidence establishes that she
experienced multiple falls.

A nurse’s note dated January 7, 2008, indicates that the nurse, responding to the
resident’s call light, went to her room and found her on the floor by her bed. The
resident reported that she had been attempting to make the bed when she tipped
over out of her wheelchair. CMS Ex. 7, at 40. Shortly thereafter, according to a
January 9 physical/occupational therapy note, R515 was seen for a falls
evaluation. According to the note, the resident did not remember how she lost her
balance. Nevertheless, the note says that R515 “is able to transfer” from bed to
wheelchair to toilet and back. No recommendations were made. CMS Ex. 7, at
42.

On January 22, 2008, R515 was found on the floor of her bathroom, with injuries
to her right knee and femur that required x-rays. She had fallen while trying to
transfer from her wheelchair to the toilet. Staff’s response was to encourage her to
use her call light to request assistance. CMS Ex. 7, at 7-8, 39.

On March 8, 2008, R515 was again found on her bathroom floor, with skin
abrasions to her right arm. The intervention recommended was “‘staff to assist
with dressing.” CMS Ex. 7, at 9-10. According to a separate nurse’s note, the
resident had put on her call light. When the nurse responded, finding R515 on the
floor, the resident said that she had leaned forward to put on her shirt and fell off
the toilet. The nurse described a scratch and reddish-blue discoloration on the
resident’s right arm. Both knees were red. The nurse advised R515 that staff
would assist her with dressing. CMS Ex. 7, at 38.

On March 14, 2008, R515 was found, uninjured, on the floor, although the
incident report does not say where, nor does it suggest any preventive measures.
CMS Ex. 7, at 11-12. A nurse’s note explains that R515 was on the floor in her
room. The resident reported that she had been trying to get from her wheelchair to
her bed, when she slipped and fell on the floor. Later that day, she complained of
right knee pain. CMS Ex. 7, at 37.

R515 apparently suffered a fall on May 10, 2008, although the record contains no
incident report. According to the nurse’s note, the nurse responded to the
resident’s call light, and found the resident on the bathroom floor. The resident
said that she was trying to use the toilet, but when she stepped from the
wheelchair, she fell to the floor. She complained of hip and leg pain and x-rays
were ordered. CMS Ex. 7, at 31, 17.

12

e On June 9, 2008, R515 was found on the floor of her room. She said that she had
been trying to reach her wheelchair. Staff told her to “use the call light for safety.
CMS Ex. 7, at 16, 17, 29.

The resident apparently told the surveyor that staff did not respond to her call light. CMS
Ex. 1, at 42.

Petitioner does not deny that all of these falls occurred. Petitioner faults the surveyor for
purportedly failing to corroborate the resident’s statement regarding staff response to her
call light, pointing out that R515 had a history of substance abuse, and was considered
“manipulative.” P. Br. at 29-30; P. Ex. 15, at 6. According to LPN Jackson, R515’s “fall
activity was mostly related to her attention seeking behavior of sliding out of her chair
when she got angry with the [n]Jurses if she could not have pain medication at non-
scheduled times.” LPN Jackson also opines that the resident’s refusal to rest promoted
the “possibility for falls.” P. Ex. 13 (Jackson Decl.). LPN Jackson does not identify any
specific intervention instituted by the facility to prevent falls.

For summary judgment purposes, I accept Petitioner’s claims regarding R515’s drug
history, efforts to manipulate, and general unreliability. Drawing all inferences in the
light most favorable to Petitioner, I accept that R515 lacks credibility, and dismiss, as
unreliable, her complaints. However, based solely on the facility’s own documents and
the allegations of its witness, I find that the facility was not providing R515 adequate
supervision and assistance devices to prevent her falls.

I note first that the resident’s mental illness and behavior problems do not relieve the
facility of its duty to protect her from falls. To the contrary, accepting as true LPN
Jackson’s claim that R515’s falls were attributable to her behavior problems, the facility
should have assessed the impact her behavior had on those falls, and implemented
interventions to protect her. Facility staff should then have reviewed periodically the
effectiveness of those interventions, particularly after she experienced a fall.

But R515’s care plans do not identify her behaviors as causes for falls, much less provide
any strategy for protecting the resident. Although a plan dated January 8, 2009 describes
inappropriate behaviors — depressive neuroses, verbal aggression, agitation, belligerence,
lack of cooperation, mood swings, and attention-seeking behavior — it does not mention
falls. The plan sets two goals: decreasing episodes of verbally abusive language and
attention seeking behavior toward staff, and increasing episodes of accepting care and
treatment. The plan says nothing about the resident deliberately sliding out of her chair
when angry nor her refusal to rest. P. Ex. 15, at 1.

Nor does the plan even offer any approaches for addressing the problems it identifies. It
contains a lengthy check-list of possible approaches with directions to “check all that
apply.” None are checked. P. Ex. 15, at 1.

13

A second plan, which is undated, identifies the “potential for injury and trauma.”
Someone has hand-written onto the printed form references to six falls — those of January
22, March 8, March 14, May 10, June 9 and August 8. The plan’s goal is to “prevent
injury . . . no incident of falls, accident, trauma or injury in 90 days.” The plan then lists
a number of general interventions: nursing to assess resident for signs and symptoms of
incorrect posture, sliding out of chair, assist resident in correcting posture as necessary;
keep call light within reach;° provide passive range of motion exercises to extremities, as
needed; siderails for safety and mobility; monitor body alignment, encourage balance of
rest and exercise; acknowledge the resident’s ability to function independently; do initial
fall risk assessment and up-date every 90 days; institute fall protocol. At the bottom of
the printed form, someone has added half side rails for mobility and safety, although that
entry is undated. Under “resolved date/evaluation date” are written 3/12/08 (which, in
light of the 90-day review provision, suggests that the plan originated about December
12, 2007) and 6/11/08. P. Ex. 15, at 6.

Aside from the short January 9 physical therapy note saying that R515 was able to
transfer among her bed, wheelchair, and toilet, I see no evidence of any assessments.
Certainly, by March 14, 2008 — which was the second or third time she fell while
attempting to make the transfer — staff should have revisited that January 9 assessment,
and should have recognized that the interventions the facility purportedly had in place
were inadequate to prevent her from falling.

Based on these undisputed facts, I find that Petitioner failed to take all reasonable steps to
prevent R515’s falls.

The facility was thus not in substantial compliance with 42 C.F.R. § 483.25(h) and, as
discussed below, CMS is authorized to impose penalties.

B. CMS is entitled to summary judgment because the undisputed facts
establish that the facility did not provide or obtain laboratory services to
meet resident needs, as required by 42 C.F.R. § 483.75(j).

A facility must provide or obtain laboratory services to meet the needs of its residents,
and is responsible for the quality and timeliness of the services. 42 C.F.R. § 483.75(j)(1).

CMS lists multiple instances in which the facility failed to provide or obtain ordered
laboratory tests:

° T note that for at least two of the six cited falls, the nurse states specifically that
she was answering the resident’s call light, which shows that R515 used the light on those
occasions.
14

Resident 522 (R522). R522 was a 37-year-old man suffering from cerebral palsy, who
was dependent on a tracheostomy tube for breathing. In June 2008, he was transferred
from the facility to the hospital with sepsis and profound electrolyte disturbances. He
was treated with antibiotics and was hydrated aggressively. When stable, he was
readmitted to the facility, but staff noted significant edema and he returned to the hospital
on June 6, 2008. Among other treatment, hospital physicians ordered that his BUN
(blood urea nitrogen) and creatinine be monitored and that his urine output be strictly
monitored. CMS Ex. 11, at 42-43, 50. He returned to the facility on June 11, 2008 with
a transfer order to monitor BUN. CMS Ex. 1, at 87. On June 12, his physician ordered a
complete blood count and electrolyte panel. CMS Ex. 11, at 5. No such tests were
performed. On June 26, 2008, R513 suffered a heart attack and died. CMS Ex. 11, at 54-
56.

Petitioner concedes that it failed to perform the ordered tests, but claims that since the
tests were not ordered “stat,” the facility was not required to perform them immediately,
and the resident died before they could be performed. LPN Jackson declares that
“{rjoutine labs can be drawn within [one] week unless otherwise stated by the physician.”
P. Ex. 13 (Jackson Decl.). For purposes of summary judgment I accept that LPN Jackson
is qualified to opine on such issues. I also accept her claim as to the standard of care.

But see Golden Living Center — Frankfurt, DAB CR1981, at 9-11 (2009). Drawing
inferences in the light most favorable to Petitioner, I am even willing to accept that these
were “routine” tests (notwithstanding the resident’s acute condition and problems with
fluid balance). This still means that the tests should have been performed no later than
June 18 and 19, and the facility’s failure to perform them violated even the somewhat lax
standard of care articulated by LPN Jackson.

Resident 527 (R527). R527’s physician ordered for her a complete blood count (CBC)
every three months. CMS Ex. 12 at 2. At the time of the survey, July 2008, her last CBC
had been performed five months earlier, in February 2008. CMS Ex. 1, at 88. Petitioner
concedes that the labs were not performed as ordered, but claims that the resident “often
refused to have labs drawn,” and points out that in July 2008 (at the time of the survey)
staff were able to “encourage her to have the lab.” P. Br. at 30; P. Ex. 13 (Jackson
Decl.); P. Ex. 16, at 8-9. That the resident refuses a blood draw does not justify the two
month delay in obtaining ordered laboratory tests. If staff are truly unable to obtain the
ordered labs, they should inform the physician, who can then modify his orders. They are
not free simply to disregard those orders. Moreover, the surveyors found no record that
R527 refused to have her blood drawn at the time the tests were due (May 2008), even
though they saw documentation of earlier refusals (in January and February 2008). CMS
Ex. 1, at 87-88. Petitioner has neither claimed nor provided any evidence of a May

15

refusal. Nor does Petitioner claim or provide any evidence of subsequent efforts to
comply with the physician’s order, prior to the time of the survey.’

Resident 528 (R528). R528’s physician ordered a monthly CBC, but, according to CMS,
tests were not performed in April, May or June 2008. CMS Ex. 1, at 88; CMS Ex. 13, at
2. Again, Petitioner concedes that the tests were not performed as ordered, although it
produces (without argument or other explanation for its significance) evidence that blood
was drawn on March 31, and test results were reported on April 1, suggesting that it may
ave complied with the order for the month of April.* For summary judgment purposes, I
accept that the order was satisfied as of April 1. Nevertheless, no lab tests were
performed for more than three months thereafter. As with R527, Petitioner claims that
R528 would “periodically” refuse to have blood drawn, and that the labs were drawn
“with encouragement” at the time of the survey. P. Ex. 13 (Jackson Decl.). Again,
although I accept these assertions as true, I do not consider “periodic” refusals sufficient
justification for the facility’s three-month-long failure to comply with the physician
order. P. Ex. 16, at 6-7. I note also that Petitioner again neither claims nor provides
evidence of any specific refusal at that time, nor any staff efforts to comply with the
physician’s order, prior to the time of the survey.

Resident 511 (R511). R511 was a 71-year-old man suffering from dementia, seizure
disorder, and Dilantin toxicity. CMS Ex. 14, at 5. On May 29, his physician ordered a
urinalysis. CMS Ex. 14, at 10. None was performed. Petitioner again concedes that the
test was not performed, but points to LPN Jackson’s claim that he “did not like giving
urine samples and would refuse on almost all attempts.” P. Br. at 31; P. Ex. 13 (Jackson
Decl.)’ For purposes of summary judgment, I accept the assertion that R511 regularly

refused to provide the sampl
for the facility’s ongoing fai
evidence of staff efforts to ol

le, but I do not consider this, by itself, sufficient justification
ure to follow the physician’s order. The facility provides no
btain a sample from this seriously demented individual.

Accepting LPN Jackson’s claim that his physician “was advised” of the refusal and opted

7 The resident’s care
provided due to the resident’

* Petitioner also provi
reported March 18, which it
explanation for performing t
Ex. 16, at 4-5.

°’ LPN Jackson also c:
provides no such documentat
claim. CMS Ex. 14. Nevert

plan must describe any required services that have not been
s refusal. 42 C.F.R. § 483.20(k)(1)(ii).

ides evidence that blood was drawn on March 17, 2008, and
characterizes as the “March report,” but offers no
he test again two weeks later, rather than a month later. P.

aims that the refusals are “well-documented” but Petitioner
tion. R511’s clinical record does not appear to support her
eless, for purposes of summary judgment, I draw all

reasonable inferences in the

ight most favorable to Petitioner, and accept her claims.
16

to obtain the information he wanted from blood tests, the facility should nevertheless
have obtained updated physician orders reflecting the change in strategy.

C. CMS is entitled to summary judgment because the undisputed
evidence establishes that it failed to provide to all of its nurse aides at
least 12 hours of in-service education annually, as required by 42 C.F.R.
§ 483.75(e)(8).

Facilities are required to provide each nurse aide with regular in-service education, based
on the outcome of the aide’s annual performance review. The training must be sufficient
to ensure the continuing competence of the nurses aides, “but must be no less than 12
hours per year.” It must address the area of weakness determined in the performance
reviews, and may address the residents’ special needs. 42 C.F.R. § 483.75(e)(8).

CMS alleges that the facility failed to provide the required in-service education for five of
its nurse aides. For each of these employees, CMS counts the number of education hours
from employment anniversary date to employment anniversary date. Petitioner
characterizes this method as “arbitrary,” and points out that the regulations do not specify
any particular means for selecting a 12-month period. But Petitioner proffers no evidence
as to the facility’s policy for calculating in-service education hours. I do not agree that a
facility satisfies the regulation merely by demonstrating 12 hours of training during any
12-month period. The problem with this approach is that it allows for overlapping
periods, and thus double-counting of training hours. At a minimum, the facility must
show a consistent policy, assuring that each employee has a minimum of 12 in-service
education hours each year.

Petitioner limits its argument to one employee, Jamilla Blanding, and claims that “in
2007 alone[,] she had well over the required 12 hours of education,” which suggests that
the facility calculates employee education hours per calendar year. P. Br. at 32.

Jamilla Blanding was hired on March 24, 1998. CMS has produced the facility’s
computer print-out for the period March 24, 2007 to March 24, 2008. It shows 8.5
education hours for that year. CMS Ex. 10, at 6. Petitioner produces a similar, but not
identical, computer print-out, which shows that CNA Blanding earned only 7.5 education
hours in 2007. P. Ex. 17, at 29. I note also that Petitioner’s print-out generally lines up
with CMS’s print out, except that it adds an additional two education hours (purportedly
earned on August 28, 2007 and March 24, 2008). However, for reasons it does not
explain, Petitioner’s print-out runs from March 24, 2007 to September 1, 2008.'°

According to Petitioner’s print-out, between March 24, 2007 and March 24,
2008, CNA Blanding earned 10.5 education hours, short of the mandatory 12.
17

Nevertheless, Petitioner has also produced some sign-in sheets for training sessions.
These show that, in addition to the 2007 hours reflected in Petitioner’s computer print-
out, Jamilla Blanding signed in for training sessions on January 11, 2007 (P. Ex. 17, at 2),
February 21, 2007 (P. Ex. 17, at 4), February 28, 2007 (P. Ex. 17, at 3), March 9, 2007
(P. Ex. 17, at 5), March 13 or 15, 2007 (P. Ex. 17, at 9) and March 16, 2007 (P. Ex. 17, at
11). Accepting all of these submissions for purposes of summary judgment, I agree that
Petitioner has pointed to material facts in dispute with respect to CNA Blanding’s in-
service education requirements.'!

Similarly, although CMS’s computer print-out shows that CNA Katherine Hilton
completed 10 training hours between her employment anniversary dates (June 29, 2007
to June 29, 2008), Petitioner’s computer print-out shows three additional classes for that
period. Notwithstanding the questions raised regarding the discrepancies between the
two print-outs, Petitioner has established material facts in dispute regarding CNA
Hilton’s in-service education hours.'? CMS Ex. 10, at 5; P. Ex. 17, at 31.

However, Petitioner has not demonstrated material facts in dispute with respect to other
employees. According to CMS’s computer print-out, Deon King completed 9.5 hours of
education between January 11, 2007 (the anniversary of his hiring) and January 11, 2008.
CMS Ex. 10, at 3. Petitioner’s print-out shows one additional class, August 28, 2007 (for
which it provides no staff sign-in sheet), but still falls short of the 12-hour requirement.

P. Ex. 17, at 27. Moreover, accepting as true Petitioner’s suggestion that it calculated
compliance based on calendar year, rather than employment anniversary, CNA King
would have completed only 9.5 hours for 2007. The training sign-in sheets that Petitioner
supplied reflect the same sessions listed on the computer print-outs (although not the
August 28, 2007 session) and do not establish any additional training. P. Ex. 17, at 5, 6,

"' But if this matter were not decided on summary judgment, Petitioner would
have a lot to explain regarding its documentation of training. Here, for example, why
does its computer print-out include the additional August 28, 2007 and March 24, 2008
education hours that are missing from the print-out it provided to the surveyor at the time
of the survey? Why are there no sign-in sheets to verify her attendance for that additional
training session? Why is Nurse Aide Blanding’s signature on the April 4 sign-in sheet
markedly different from her signature on the other sign-in sheets? Why does it appear to
be the same as the signatures of four other purported attendees (including Deon King and
Felice Dillard) whose names immediately precede hers? Why does Deon King’s
signature differ so markedly on all but two of the sign-in sheets? Compare P. Ex. 17 at 5-
6, with P. Ex. 17, at 10, 12, 13, 14.

» Based solely on calendar year 2007, I see evidence that she completed 13 hours
of education, although, again, questions arise regarding Petitioner’s documentation. P.
Ex. 17, at 3, 4, 5, 7, 8, 9, 10, 12, 20.
18

10, 12, 13, 14. The undisputed evidence thus establishes that CNA King did not satisfy
the minimum in-service education requirements.

CMS’s computer print-out shows that Nurse Aide Linda Moultire completed 11 hours of
education between her employment anniversary dates (January 10, 2007 to January 10,
2008). CMS Ex. 10, at 4. Petitioner’s print-out reflects the same number of hours
between those two dates. P. Ex. 17, at 23. The training sign-in sheets add no additional
ours for calendar year 2007; they reflect some of the classes listed on the print-outs. P.
Ex. 17, at 4, 6, 10, 12, 14. The undisputed evidence establishes that CNA Moultrie did
not satisfy the minimum in-service education requirements.

Finally, both CMS’s and Petitioner’s computer print-outs reflect only 10 hours of in-
service education for Felece Dillard from January 3, 2007 until January 3, 2008, her
employment anniversary dates. CMS Ex. 10, at 7; P. Ex. 17, at 25. The sign-in sheets
provided reflect attendance at the sessions listed on the print-outs. P. Ex. 17, at 4, 6, 9,
10, 12, 15, 16. Nor has Petitioner suggested any 12-month period during which she
would have completed the requisite training hours.

Thus, the undisputed evidence establishes that at least three of the facility’s nurse aides
ailed to complete the required in-service training, so Petitioner was not in substantial
compliance with 42 C.F.R. § 483.75(e)(8).

D. Because the facility was not in substantial compliance with program
requirements, CMS may impose a remedy, including termination, and I
have no authority to review CMS’s determination to impose a remedy nor
its choice of remedies."*

CMS argues — and Petitioner does not dispute — that “any one of these deficiencies is
sufficient to support the remedies appealed by the facility” (denial of payment for new
admissions and termination of the facility’s provider agreement). CMS Br. at 3.

The statute gives CMS the authority to impose one or more enforcement remedies
whenever a facility is not in “substantial compliance,” i.e., its deficiencies pose no actual
harm but have the potential for causing more than minimal harm. Act § 1819(h); see also
42 C.F.R. §§ 488.301, 488.402, 488.406. A facility may not appeal the choice of remedy.
42 C.F.R. §§ 488.408(g)(2), 498.3(d)(1 1), 498.5 (CMS’s choice of remedy is not an
initial determination and is therefore not reviewable).

® Because the deficiencies discussed above, either individually or collectively,
establish that the facility was not in substantial compliance and that CMS therefore has
the authority to impose the remedies it has imposed, I need not consider the facility’s
compliance with 42 C.F.R. § 483.25(k).
19

The regulations also explicitly allow CMS to terminate a facility’s provider agreement if
it finds that the facility is not in substantial compliance with program requirements,
regardless of whether immediate jeopardy is present. 42 C.F.R. §§ 488.412(a),
488.456(b); Rosewood Living Center, DAB No. 2019, at 8-9 (2006).

Thus, because I find that the facility was not in substantial compliance with program
requirements, CMS is authorized to impose the remedies it has imposed.

E. The facility must meet program participation requirements without
regard to the quality of the survey.

Finally, Petitioner’s principal complaint centers around the conduct of the state surveyor,
which, it suggests, taints the entire process and shows that “none of the factual allegations
in the [statement of deficiencies] can be trusted.” P. Br. at 27-28. As the above
discussion shows, the facility’s own documents and the statement of its witness establish
its substantial noncompliance, without regard to surveyor testimony or the allegations set
forth in the statement of deficiencies. The issue here is not whether a state surveyor
meticulously followed CMS instructions and guidelines, which, though useful, do not
constitute enforceable, substantive rules. Beverly Health & Rehab. Services v.
Thompson, 223 F.Supp. 2d 73, at 99-106 (D.D.C. 2002); Oakwood Community Center,
DAB No. 2214, at 16 (2008); Aase Haugen Homes, Inc., DAB No. 2013, at 15 (2006).
The issue is the facility’s own compliance or lack thereof. In this regard, the regulations
are explicit: “Inadequate survey performance does not 1) relieve a [skilled nursing
facility] or [nursing facility] of its obligation to meet all requirements for program
participation; or 2) invalidate adequately documented deficiencies.” 42 C.F.R.

§ 488.318(b).

IV. Conclusion

Accepting as true all of Petitioner’s factual assertions, I find that the facility was not in
substantial compliance with the Medicare requirements governing quality of care —
accidents (42 C.F.R. § 483.25(h)); laboratory services (42 C.F.R. § 483.75(j)); and in-
service education (42 C.F.R. § 483.75(e)(8)). CMS was therefore authorized to impose
penalties, including denial of payment for new admissions and termination of the
facility’s Medicare provider agreement. | therefore grant CMS’s motion for summary
judgment.

/s/
Carolyn Cozad Hughes
Administrative Law Judge


Department of Health and Human Service
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

)
In the Case of: )
)
Columbus Park Nursing & Rehabilitation ) Date: November 27, 2009

Center (CCN: 14-5834), )
)

Petitioner, ) Docket Nos. C-09-758

) Decision No. CR2037
v. )
)
Centers for Medicare & Medicaid Services. )
)

DECISION

The request for hearing of Petitioner, Columbus Park Nursing & Rehabilitation Center, is
dismissed pursuant to 42 C.F.R. § 498.70(b), as Petitioner has no right to a hearing.

I. Background

Petitioner requested a hearing before an administrative law judge (ALJ) by letter dated
September 21, 2009. Petitioner requests review as to deficiencies cited by the survey of
its facility completed on July 20, 2009 by the Ilinois Department of Public Health (state
agency) and proposed enforcement remedies. The request for hearing was docketed as C-
09-758 and assigned to me for hearing and decision on September 29, 2009.

On October 15, 2009, CMS filed a motion to dismiss this case and a motion to stay
further proceedings pending a ruling upon its motion with CMS exhibits (CMS Ex.) 1
through 3. On November 4, 2009, Petitioner filed an opposition to the CMS motion to
dismiss (P. Opp.) with Petitioner’s exhibit (P. Ex.) A. The offered exhibits are admitted.

II. Findings of Fact, Conclusions of Law, and Discussion

My conclusions of law are set forth in bold followed by my findings of fact and
discussion.
A. CMS imposed no enforcement remedies in this case and therefore
Petitioner has no right to hearing before an ALJ.

B. Ihave no jurisdiction or authority to review alleged deficiencies
from a survey absent enforcement remedies based upon those
deficiencies.

C. Dismissal of Petitioner’s request for hearing pursuant to 42 C.F.R.
§ 498.70(b) is appropriate because Petitioner has no right to a hearing.

1. Pertinent Facts

The state agency completed a complaint survey of Petitioner on July 20, 2009. No
extended survey was conducted. The Statement of Deficiencies (SOD) for the survey
alleges that Petitioner violated 42 C.F.R. § 483.13(b)(1)(i) with one resident suffering
actual harm due to the violation. CMS Ex. 1. The state agency notified Petitioner by
letter dated July 23, 2009, that it was proposing that CMS impose the following
enforcement remedies: directed in-service training and a civil money penalty of $200 per
day effective July 20, 2009. The state agency also advised Petitioner that it would be
allowed an opportunity to correct the alleged deficiency before any remedies would be
imposed. CMS Ex. 2, at 2. CMS notified Petitioner by letter dated October 5, 2009, that
the state agency determined, based on a revisit survey, that Petitioner had returned to
substantial compliance with program participation requirements effective August 4, 2009,
and that no remedies would be imposed for the alleged deficiency. CMS Ex. 3.

2. Analysis

CMS argues in its motion to dismiss that no remedy was imposed; that Petitioner has no
right to a hearing; and that dismissal of the request for hearing is required. Petitioner
argues that the request for hearing should not be dismissed and that Petitioner should be
accorded a hearing. I conclude that Petitioner’s request for hearing must be dismissed.
CMS determined to impose no enforcement remedies, Petitioner has no right to review,
and I have no authority to render a decision that addresses the merits of the alleged
deficiency.

Petitioner advances four theories in its opposition to the CMS motion to dismiss, which I
summarize as follows: (1) citation of the violation was based on an improper conclusion
that Petitioner provided substandard quality of care without giving Petitioner an
opportunity to challenge the findings; (2) citation of a regulatory violation and alleging a
resident suffered actual harm “amounts to an adverse and significant
consequence/interference with a property right;” (3) citation of a regulatory violation
without affording Petitioner a right to hearing is “a deprivation of [Petitioner’s] rights, in
contradiction of fundamental fairness and procedural due process enumerated in the
Constitution;” and (4) citation of a violation without the opportunity for hearing

“encourages error and abuse of the survey process.” P. Opp. 1-2. I conclude that the
theories Petitioner presents in its opposition to the motion to dismiss are without merit.

Petitioner does not dispute that CMS decided to impose no enforcement remedies in this
case. Petitioner does not specifically address the rationale of various ALJs and appellate
panels of the Departmental Appeals Board (the Board) in prior cases in which a long-
term care facility has been found to have no right to an ALJ hearing when CMS imposed
no enforcement remedy or CMS reopened and revised an initial determination and
rescinded all enforcement remedies resulting in dismissal of a pending request for hearing
pursuant to 42 C.F.R. § 498.70(b). I find the rationale expressed in the prior Board and
ALJ decisions persuasive.

A provider does not have a right to a hearing to challenge every action by CMS with
which it disagrees. Only certain actions by CMS or its delegates trigger hearing rights.

In general, a participating long-term care facility will have a right to a hearing if CMS
makes an initial determination to impose an enforcement remedy against that facility. 42
C.F.R. § 498.3(b)(13). The possible remedies that CMS might impose against a facility
are specified at 42 C.F.R. § 488.406(a). No right to a hearing exists pursuant to 42
C.F.R. § 498.3(b)(13) unless CMS determines to impose - and actually imposes - one of
the specified remedies. 42 C.F.R. § 488.408(g) (“facility may appeal a certification of
noncompliance leading to an enforcement remedy”); Fountain Lake Health &
Rehabilitation, Inc., DAB No. 1985 (2005); The Lutheran Home - Caledonia, DAB
CR674, aff'd, DAB No. 1753 (2000); Schowalter Villa, DAB CR568, aff'd, DAB No.
1688 (1999); Arcadia Acres, Inc., DAB CR424, aff'd, DAB No. 1607 (1997); Twin Pines
Nursing and Rehabilitation Center, DAB CR1601 (2007). The Secretary of Health and
Human Services specifically rejected a proposal to grant hearing rights for deficiency
findings that were made without the imposition of remedies. 59 Fed. Reg. 56,116, 56,158
(Nov. 10, 1994) (“if no remedy is imposed, the provider has suffered no injury calling for
an appeal”).

It is specifically the imposition or proposed imposition of an enforcement remedy and not
the citation of a deficiency that triggers the right to a hearing under 42 C.F.R. Part 498.
When the enforcement remedy is eliminated, so too, is Petitioner’s right to review and
my authority to conduct the review. Fountain Lake Health & Rehabilitation, Inc., DAB
No. 1985; Twin Pines Nursing and Rehabilitation Center, DAB CR1601; see EagleCare,
Inc. d/b/a/ Beech Grove Meadows, DAB CR923 (2002); Schowalter Villa, DAB No.
1688; Arcadia Acres, Inc., DAB No. 1607; see also The Lutheran Home — Caledonia,
DAB No. 1753; Walker Methodist Health Center, DAB CR869 (2002); Charlesgate
Nursing Center, DAB CR868 (2002); D.C. Association for Retarded Citizens, DAB
CR776 (2001); Alpine Inn Care, Inc., d/b/a Ansley Pavilion, DAB CR728 (2001);
Woodland Care Center, DAB CR659 (2000); Fort Tryon Nursing Home, DAB CR425
(1996). In each of these cases, the failure or inability of the petitioner to demonstrate that
the appealed survey findings and deficiency determinations had resulted in a remedy was
fatal to its appeal. In each of the cases, the appeal was dismissed. The appellate panels
of the Board and the ALJs who decided the cases have uniformly concluded that a

citation of deficiency that is not the basis for an enforcement remedy, or that results in the
imposition of a remedy that is later rescinded or reduced to zero, does not trigger the right
to a hearing under 42 C.F.R. Part 498.

Petitioner argues that it should be granted the opportunity to challenge the conclusions of
the survey as incorrect and against the weight of the evidence. P. Opp. at 2-3. Petitioner
argues that the survey conclusions are based upon the unreliable statements of the
resident, the subject of the alleged violation, who suffered a chronic mental illness.
Petitioner’s allegations go to the merits of the regulatory violation cited by the survey and
are not subject to my review because, under the controlling regulation, Petitioner has no
right to review of the survey allegations. Petitioner argues that the citation of a violation
that allegedly resulted in actual harm to a resident has adverse and significant
consequences to the facility, including: the violation is easily accessible by the public on
the internet without any indication that the violation is subject to dispute; the alleged
violation negatively impacts Petitioner’s “star rating” and its reputation which will likely
deter resident admissions and referrals; and the violation will likely negatively impact
future surveys and any resulting enforcement remedies and may jeopardize Petitioner’s
license. P. Opp. at 4-6. The adverse consequences foreseen by Petitioner are speculative.
However, even if I accept that the alleged adverse consequences are possible, the
regulations nevertheless limit my authority to reviewing those cases where an
enforcement remedy authorized by the regulations is actually imposed. None of the
adverse consequences foreseen by Petitioner are enforcement remedies listed in the
regulations. Petitioner suggests that CMS has the option of simply removing the alleged
violation from its record (P. Opp. at 5), and while that may be correct, it is not within my
authority to direct CMS or the Secretary to take such action. Petitioner argues that
denying it a hearing results in a violation of its right to due process and undermines
principles of fundamental fairness. P. Opp. at 6-8. Petitioner cites cases where the courts
have recognized that a party is entitled to a hearing when governmental action deprives
the party of a protected interest. However, it is not within my authority to address
Petitioner’s Constitutional challenges to either the Secretary’s regulations or the Social
Security Act. Finally, Petitioner argues that depriving it of a hearing facilitates error and
encourages abuse of the survey process. P. Opp. at 8-9. This argument challenges the
policy underlying the Secretary’s regulations, and is not within my authority to review.
Florida Health Sciences Center, Inc., d/b/a Tampa General Hospital, DAB No. 2263, at
5-6 (2009) (Board and ALJs do not have authority to ignore unambiguous statues or
regulations on grounds that they are unconstitutional).

I conclude, based upon the Secretary’s regulations and the rationale of prior decisions by
the Board and ALJs, that Petitioner does not have a right to a hearing in this case and I
have no jurisdiction to grant the review requested.
II. Conclusion

For the foregoing reasons, Petitioner’s request for hearing is dismissed pursuant to 42
C.F.R. § 498.70(b).

/s/
Keith W. Sickendick
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Decision No. CR2036
Centers for Medicare & Medicaid
Services.

In the Case of: )
)

Peter Manis, M.D., FACEP ) Date: November 20, 2009
PMMDOC, Inc. (NPI: 1447313978), )
)
Petitioner, )
)

-V.- ) Docket No. C-09-634

)
)
)
)

DECISION DISMISSING REQUEST FOR HEARING

I dismiss the hearing request of Petitioner, Peter Manis, M.D., because under the
applicable regulations Petitioner does not have a right to a hearing before me.

I. Background

Petitioner filed a hearing request which asked for further appeals rights with respect to
the effective date given Petitioner for billing Medicare. Petitioner contends that under
previous policy (prior to January 1, 2009), physicians were allowed to retroactively bill
Medicare for services provided to Medicare beneficiaries for 27 months from the
effective date of enrollment. Petitioner indicated that he previously was certified as a
Medicare provider but as part of partnership practice. Because he was beginning a new
solo practice, Petitioner was required to apply for new Medicare certification even though

ie had previously been billing his services to Medicare for over 20 plus years under his
previous practice. Petitioner contends that even though he did not file his application
until February 23, 2009, he began treating patients in November, 2008 based on this
previous policy thinking that he would still receive payment for his services. Petitioner
was approved for Medicare enrollment effective February 23, 2009 and, thus, under the
regulations in effect as of January 1, 2009, his right to bill for services to Medicare
beneficiaries became effective as of January 24, 2009.

This case was assigned to me for a hearing and a decision. Petitioner responded to my
initial Order that he had submitted everything he wished for me to consider and that he
did not have any testimony or witnesses he wished to present.
IL. Issue, findings of fact and conclusions of law

A. Issue
The issue is whether the Petitioner has a right to a hearing before me.

B. Findings of fact and conclusions of law

I make findings of fact and conclusions of law (Findings) to support my decision in this
case. I set forth my Findings below as separate headings.

1. The Petitioner does not have a right to a hearing.

The Petitioner, a physician, requested a hearing because he is dissatisfied with the policy

of the Medicare program governing payment
dates of his enrollment in Medicare.

Because Petitioner was changing from a grou
to obtain a new Medicare certification. He as:

or claims for services generated prior to the

p practice to a solo practice, he was required
serts that he began the process in November

2008, but had problems obtaining a National Provider Identifier and therefore did not

submit his application for enrollment until Fel

bruary 23, 2009. Petitioner provided

services to one or more Medicare beneficiaries from November 1, 2008, prior to the date
of his enrollment, through February 23, 2009, and seeks to claim reimbursement for those
services. Petitioner argues that new Medicare regulations bar reimbursement for claims
for services that Petitioner provided prior to the effective date of his enrollment and he is
dissatisfied with that likely outcome. He contends that at the time he began the
enrollment process the previous policy, which allowed him to bill back for services
rendered 27 months prior to the effective date of his enrollment in the Medicare program,
was in effect.

At its heart, this case appears to involve a challenge to regulations which govern the time
frame for which Medicare will retrospectively reimburse items or services provided prior
to the effective dates of enrollment by physicians who are newly enrolled in the Medicare
program (or re-enrolled at a point in time after enrollment has lapsed). The regulations
are 42 C.F.R. §§ 424.520(d) and 424.521(a). These are relatively newly enacted
regulations which became effective in January 1, 2009.
The regulations provide, first, that the effective date for Medicare billing privileges for
physicians and certain other practitioners is the later of the date of filing of a Medicare
enrollment application that was subsequently approved by a Medicare contractor or the
date that an enrolled physician or other practitioner first began furnishing services at a

new practice location. 42 C.F.R. § 424.520(d). This regulation establishes the point in
time (effective date) from which Medicare may determine to reimburse retrospectively
claims for services provided by an enrolled physician.

Medicare will reimburse retrospectively a claim for services by an enrolled physician for
up to 30 days prior to the effective date of enrollment “if circumstances precluded
enrollment in advance of providing services to Medicare beneficiaries.” 42 C.F.R.

§ 424.521(a)(1). It will reimburse retrospectively for up to 90 days prior to the effective
date of enrollment in the event that a Presidentially-declared disaster precluded
enrollment in advance of providing services. 42 C.F.R. § 424.521(a)(2). There are no
other circumstances under which retrospective reimbursement is permitted.

Petitioner’s challenge of the regulations and the policies that they embody is not
something that I have the authority to hear and decide. As a delegate of the Secretary of
this Department, I must apply her policies as they are stated in regulations. I have no
authority to declare a regulation to be unlawful or ultra vires. Consequently, I may not
hear Petitioners’ challenge to the lawfulness of 42 C.F.R. §§ 424.520(d) and 424.521(a).
Nor do I have the authority to grant exceptions to this policy. Consequently, I may not
direct that it be waived in the case of this Petitioner.

l only have authority to hear cases where Medicare enrollment was denied or revoked,
but here Petitioner’s Medicare enrollment was not improperly denied or revoked. See 42
C.F.R. § 498.3(b)(17).? While Petitioner might argue that I do have authority to hear and
decide this matter pursuant to 42 C.F.R. § 498.3(b)(15); that particular authority is
inapplicable here as Petitioner does not contend that he was entitled to an earlier effective
date of enrollment; rather he argues about when he may begin billing for his services.

See 42 C.F.R. § 498.3(b)(15). This section therefore does not confer hearing rights with
respect to the issue Petitioner here asks me to review.

' Petitioner avers that the Medicare program previously gave newly enrolled
physicians a 27-month grace period during which claims would be reimbursed
retrospectively. Petitioner complains that it is unreasonable for the Medicare program to
change its policy from the 27-month period to the periods that are now permitted, under
defined circumstances, by 42 C.F.R. § 424.521(a)(1) and (2).

2 The applicable regulations do not provide appeal rights for this issue. The
regulations only provide review when a provider is denied enrollment or when a
provider’s enrollment has been revoked (42 C.F.R. §424.545(a) and 42 C.F.R. §
495.3(b)(17)) and here Petitioner’s Medicare enrollment was neither denied or revoked.
2. I must dismiss Petitioner’s hearing request.

I must dismiss a hearing request in the circumstance where a party requesting a hearing
has no right to a hearing. 42 C.F.R. § 498.70(b). I conclude that Petitioner has not
established a right to a hearing. Consequently, I dismiss this case.

/s/
Alfonso J. Montafio
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

The Centers for Medicare & Medicaid
Services.

)
In the Cases of: )
)
David A. Baker, M.D., ) Date: November 20, 2009
Jettie Person, M.D., )
Richard Berger, M.D., )
Christopher Allen Sanford, M.D., ) Docket Nos. C-09-729
) C-09-730
Petitioners, ) C-09-731
) C-09-732
- ve ) Decision No.CR2035
)
)
)
)

DECISIONS DISMISSING REQUESTS FOR HEARING

I dismiss the hearing requests of the four Petitioners whose names are recited in the
caption of these decisions. None of these individuals has a right to a hearing before me.
I consolidate these decisions into a single document for reasons of efficiency. The
controlling issue is identical in each case and the same interested entity has filed a
hearing request on behalf of each of the Petitioners. However, each of these Petitioners
has an individual and independent right to appeal my decision in his or her case.

I. Background

Each of the Petitioners in these cases is on the staff of University of Washington
Physicians, an entity which describes itself as the largest medical group in the State of
Washington. In each case this entity filed a hearing request on behalf of the named
Petitioner asking that the Petitioner be given a “retro effective date of enrollment” in the
Medicare program. The hearing requests in these cases are in all other respects
essentially identical. The cases were assigned to me for a hearing and a decision.

On October 21, 2009 I issued decisions in ten other cases in which University of
Washington Physicians had filed hearing requests substantially identical to those under
consideration here. Bradley D. Anawalt, M.D. et als., DAB CR2021 (2009). In the
Anawait decisions I dismissed the hearing requests because I found that the requests did
not raise any issue of which I had authority to hear and decide. As with the present cases
the hearing requests at issue in the Anawalt decisions ask that individual physicians be
assigned “retro effective” enrollment dates in Medicare.

On October 22, 2009 I sent an order to the parties in each of the present cases advising
them that I was contemplating issuing decisions in these cases that are consistent with my
decisions in Anawalt et als. and giving the parties the opportunity to comment. Order
Giving Parties the Opportunity to File a Statement or a Brief, October 22, 2009. None of
the individual Petitioners or University of Washington Physicians filed anything in
response to my order. Neither did counsel for The Centers for Medicare & Medicaid
Services (CMS). On November 16, 2009 I asked the staff attorney at the Civil Remedies
Division who was assigned to work with me on these cases to contact counsel for CMS to
ascertain whether he intended to file a response to my October 22 order. Counsel advised
her that he was not filing anything.

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

These cases all have the identical issue, that being whether the Petitioner in each of them
has a right to a hearing before me.

B. Findings of fact and conclusions of law

I make findings of fact and conclusions of law (Findings) to support my decisions in
these cases. I set forth my Findings below as separate headings.

1. The Petitioners do not have a right to a hearing.

The four hearing requests each state the same complaint. Petitioner in each of these cases
recently enrolled in Medicare as a participating physician. University of Washington
Physicians complains on behalf of the individual Petitioners that it is prohibited by a
recent (January 2009) amendment to Medicare billing regulations from obtaining
reimbursement for Medicare claims for covered items or services that the Petitioners may
have provided to Medicare beneficiaries prior to the dates of their enrollment. 42 C.F.R.
§ 424.52 1(a).

The regulation in question effectuates a policy change. Prior to its enactment Medicare
would reimburse newly enrolled physicians for claims for Medicare covered items or
services that were provided as far back as 23 months prior to the enrollment date. The
new regulation effectively does away with retrospective reimbursement except in
narrowly defined instances that are not implicated here. 42 C.F.R. § 424.521(a)(1), (2).
By filing hearing requests on behalf of these Petitioners University of Washington
Physicians essentially challenges the regulation and the policy that it implements as being
unfair.

I have no authority to hear and decide that assertion. My authority in a case like these is
limited by regulations. I may hear and decide a challenge to CMS’s determination of an
effective date of enrollment. 42 C.F.R. § 498.3(b)(15). And, I may hear and decide a
challenge to a determination that a provider is ineligible for enrollment or that his or her
enrollment should be revoked. 42 C.F.R. § 498.3(b)(17). But, I do not have authority to
question the Secretary’s policy determinations or to declare that a regulation is unlawful
or ultra vires a statute. Nor do I have the authority to order that a regulation’s authority
be waived in any case.

Here, University of Washington Physicians has raised no issues on behalf of the four
Petitioners that I have authority to hear and decide. The sole argument that it makes on
behalf of each Petitioner is that the policy change made by 42 C.F.R. § 424.521 (a) is
unfair. It has not asserted, for example, that CMS improperly determined the date when
each of the four Petitioners qualified for enrollment as Medicare participating providers.
Nor has University of Washington Physicians asserted that CMS or its contractor
improperly denied enrollment to any of the Petitioners.

Under applicable regulations the “effective date” of enrollment for a physician may only
be the /ater of two dates: the date when the physician filed an application for enrollment
that was subsequently approved by a Medicare contractor charged with reviewing the
application on behalf of CMS; or the date when the physician first began providing
services at a new practice location. 42 C.F.R. § 424.520(d). University of Washington
Physicians has not asserted in any of these cases that CMS or its contractor erred in
determining either a Petitioner’s application filing date or the date when the Petitioner
began providing services at a new practice location.

2. I must dismiss Petitioner’s hearing requests.

I may dismiss a hearing request in the circumstance where a party requesting a hearing
has no right to a hearing. 42 C.F.R. § 498.70(b). None of these Petitioners has
established a right to a hearing. Consequently, I dismiss these cases.

/s
Steven T. Kessel
Administrative Law Judge