Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Mission Oaks Manor,
(CCN: 67-5409),

Petitioner,
Vv.
Centers for Medicare & Medicaid Services.
Docket No. C-09-384
Decision No. CR2102

Date: April 1, 2010

DECISION

This case presents questions involving the proper use of restraints in a long-term care
facility.

Petitioner, Mission Oaks Manor (Petitioner or facility), is a long-term care facility located
in San Antonio, Texas, that participates in the Medicare program. The facility restrained
mentally ill and sometimes volatile residents in geriatric chairs (geri-chairs)' using pelvic
restraints. On multiple occasions, residents deliberately flipped or otherwise fell to the
floor while so restrained, resulting in multiple injuries and one fatality. The Centers for
Medicare & Medicaid Services (CMS) has determined that the facility was not in
substantial compliance with Medicare requirements governing restraints and resident
neglect, and that its deficiencies posed immediate jeopardy to resident health and safety.
CMS has imposed two per-instance civil money penalties (CMPs) of $5,000 each.

The parties have filed cross-motions for summary judgment.

For the reasons set forth below, I find that the facility was not in substantial compliance
with Medicare program requirements, and that the penalties imposed -- $5,000 per
instance for two of the deficiencies cited (total: $10,000) -- are not unreasonably high. I
therefore grant CMS’s motion for summary judgment and deny Petitioner’s.

' A geri-chair is a reclining chair that sits on casters. CMS Ex. 23; CMS Ex. 28 at 7.
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
twelve 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 January 27, 2009, CMS
determined that the facility was not in substantial compliance with Medicare participation
requirements, and that deficiencies cited under 42 C.F.R. § 483.13(a) (Tag 221 — physical
restraints) and 42 C.F.R. § 483.13(c) (Tags F225 and F226 — staff treatment of residents)
posed immediate jeopardy to resident health and safety. CMS Exs. 1, 2. Based on these
findings, CMS has imposed two per instance civil money penalties: $5,000 for the
deficiencies cited under § 483.13(a), and $5,000 for the deficiencies cited under 42
C.F.R. § 483.13(c). CMS Exs. 1, 3.

Although other deficiencies were cited, CMS rescinded all other penalties when it
determined that the facility achieved substantial compliance.

Petitioner timely requested a hearing.

The parties have filed cross-motions for summary judgment and memoranda in support of
their positions (CMS MSJ Br.; P. MSJ Br.) as well as response briefs (CMS Response; P.
Response). CMS has submitted 29 exhibits (CMS Exs. 1-29). Petitioner has submitted
15 exhibits (P. Exs. 1-15).

IL. Issues

I consider whether summary judgment is appropriate.

On the merits, the issues before me are: 1) whether, at the time of the survey, the facility
was in substantial compliance with 42 C.F.R. §§ 483.13(a) and (c); and 2) if the facility

was not in substantial compliance, were the remedies imposed -- $5,000 per instance for
each of the two deficiencies cited — reasonable.
3

Because no penalties were imposed for the other deficiencies cited, Petitioner is not
entitled to review of them. 42 C.F.R. §§ 498.3(b)(13); 498.3(d)(10)(ii); Schowalter Villa,
DAB No. 1688 (1999).

Nor have I the authority to review the immediate jeopardy determination. An ALJ may
review CMS’s scope and severity findings (which include a finding of immediate
jeopardy) only if a successful challenge would affect the range of the CMP, or if CMS

as made a finding of substandard quality of care that results in the loss of approval of a
acility’s nurse aide training program. 42 C.F.R. § 498.3(b)(14); 42 C.F.R. §
498.3(d)(10); see Evergreen Commons, DAB No. 2175 (2008); Aase Haugen Homes,
DAB No. 2013 (2006). Here, the penalty imposed is a per instance CMP, for which the
regulations provide only one range ($1,000 to $10,000), so the level of noncompliance
does not affect the range of the CMP. 42 C.F.R. § 488.438(a)(2). Nor does CMS’s scope
and severity finding affect approval of the facility’s nurse aide training program. The
acility was not enrolled in a nurse aide training program at the time of the survey.
Moreover, the state could not approve the facility’s nurse aide training program even if it
ad one, because the facility has been assessed a CMP of $5,000 or more. Act §
819(f)(2)(B); 42 C.F.R. § 483.151(b)(2)(iv).

Finally, I have no authority to review Petitioner’s constitutional claims.
III. 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
68, 173 (6th Cir. 2004) (quoting Celotex Corp. v. Catrett, 477 U.S. 317, 323-24 (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.

918 (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, DAB No. 2274 at 4; Livingston Care Center, DAB No. 1871 at
5 (2003).
4

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). However, 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.”).

Here, I have accepted, for summary judgment purposes, every one of Petitioner’s
supported allegations, even those for which the support seems extraordinarily weak.

A. CMS is entitled to summary judgment that the facility was not in substantial
compliance with 42 C.F.R. § 483.13(c), because the undisputed evidence
establishes that staff repeatedly left vulnerable residents restrained in geri-
chairs, knowing that they were capable of flipping themselves over when so
restrained.”

Facilities must develop and implement written policies and procedures that prohibit
resident neglect. 42 C.F.R. § 483.13(c). “Neglect” means failure to provide goods and
services necessary to avoid physical harm, mental anguish, or mental illness. 42 C.F.R. §
488.301. See Jennifer Matthew Nursing & Rehabilitation Center, DAB No. 2192 at 19
(2008).

Resident 13. CMS has presented evidence (the facility’s own documents) establishing that,
in the middle of the night, facility staff restrained Resident 13 (R13), a mentally ill and
agitated resident, in a geri-chair and left him, unsupervised, in one of the facility’s dining
rooms even though he had a history of flipping himself over when so restrained. Petitioner
has not come forward with evidence suggesting a dispute over these facts. By itself, this
undisputed evidence regarding staff treatment of R13 establishes the facility’s substantial
noncompliance with 42 C.F.R. § 483.13(c) and justifies imposing significant penalties.

R13 was a 60-year-old man when first admitted to the facility on August 28, 2008. His
diagnoses included schizoaffective disorder, dementia, hypertension, obesity, sleep
apnea, gastroesophageal reflux disease, and other ailments. CMS Ex. 20 at 1, 8, 19, 20,
42. He had neither a history nor diagnosis of seizures. P. Ex. 13 at 24, 98-104. See P.
Ex. 6 at 1 (Rapp Decl. § 3).

> My findings of fact/conclusions of law are set forth, in italics and bold, in the discussion
captions of this decision.
5

At the time of his admission, R13 was able to walk independently, using a cane or
walker. P. Ex. 13 at 26. Staff determined that he was at risk for falls and elopement
(CMS Ex. 20 at 73-74), and his care plan listed a number of interventions to address these
issues, including non-skid shoes, placing needed articles within his reach, encouraging
him to use a walker for ambulation, encouraging rest periods, reminding him to change
positions slowly and to use his call light, therapy screens/referrals as needed, monitoring
certain medications, and providing physical therapy reviews as needed. CMS Ex. 20 at
75.> No restraints were ordered or in use for him. CMS Ex. 20 at 34, 36.

Facility response to R13’s deteriorating behaviors. As reflected in nurses’ notes,
however, by November 2008, R13 was engaging in self-injurious behaviors, and, on a
few occasions, he attacked the staff who attempted to intervene. In response, staff began
regularly to obtain, by telephone, physician orders authorizing them to restrain him in a
geri-chair, using a pelvic restraint. P. Ex. 13 at 6; P. Ex. 6 at 1 (Rapp Decl. 93).

Specifically:

e A nurse’s note dated November 5, 2008, says that at about 9:10 p.m. a nurse aide
observed R13 attempting to hit his face against a door frame. When she
intervened, he “punched her in the face.” He then went into the hallway and “got
onto the floor [and] placed self on floor.” He yelled for the nurses to help him,
claiming to have fallen. They put him in a geri-chair with a pelvic restraint, citing
“lack of safety awareness.” They left him at the nurses’ station “for closer
observation.” P. Ex. 13 at 6.

A telephone order dated November 5, 2008, says “placed” resident in geri-chair
with a pelvic restraint for 24 hours, due to “lack of safety awareness”; release
every two hours. CMS Ex. 20 at 54.

e A nurse’s note written at 3:00 a.m. on the morning of November 12, 2008,
describes R13 as awake and “very anxious, wanting medications for his anxiety.”

> Both CMS and Petitioner have described this care plan as “dated January 9, 2009.”
CMS MSJ Br. at 6; P. MSJ Br. at 20. In fact, the document was initiated on September
10, 2008, with a goal date of December 10, 2008. The January 9 date was added later,
presumably following a January 2009 review. The original plan addressed R13’s
“potential for falls & related injuries” related to cognitive deficits/impaired safety
awareness, psychotropic medication use, unsteady gait, and visual deficits. Over time,
additional behaviors and interventions were added, and those additions are dated. See 42
C.F.R. § 483.20(k). The staff revisited the plan in November 2008 and January 2009.
The entry “throws self to floor” sits between two dates: “11-24-08 . . . throws self to
floor... 1-5-09.” Presumably, this means that the behavior was first noted in the care
plan on November 24, and, as of January 5, the behavior continued. It appears that no
interventions were added to address that behavior on either date, except to “intervene
PRN.”

6

He was given Ativan. P. Ex. 13 at 7. At 2:30 in the afternoon, a nurse’s note
indicates that R13 was in the office of the Director of Nursing (DON). He
announced that he was going to do “bad things” and then lay on the floor and
knocked over a ceramic column with a vase on it. Staff put him in a geri-chair,
according to the note, due to “lack of safety awareness.” They again placed him at
the nurses’ station “for closer observation.” P. Ex. 13 at 7.

A telephone order dated November 12, 2008, from Dr. Valdez (Olivia Valdez,
M.D.) authorizes placing the resident in a geri-chair with “pelvic” for 24 hours,
due to “lack of safety awareness,” and to release for ten minutes every two hours.
CMS Ex. 20 at 53.

A note written at 4:00 a.m. on November 13, 2008, says that R13 “continued to be
in [geri-chair] for behavior” but was released at 1:00 a.m. and assisted to bed. P.
Ex. 13 at 7.

A report of a physical examination on Geriatrics Associates of America letterhead
is dated November 13, 2008, and refers to an un-witnessed fall. The report does
not mention behavior problems or restraints. P. Ex. 13 at 75.

Ina psychiatric follow-up, dated November 14, 2008, Dr. Valdez describes R13
as very anxious, worried, fearful, pacing, restless, and agitated. Dr. Valdez writes
that R13’s paranoia and delusions continue and mentions “depressed, needy.” She
describes his affect as “flat, tense, suspicious.” Her plan is to increase his
medications. She says nothing about physical restraints, or lack of safety
awareness. P. Ex. 13 at 31.

At 1:00 in the afternoon of November 18, 2008, according to the nurse’s note,
R13 was “noted sitting on the floor of his room,” claiming that he had fallen and
hit his head. No injuries were noted. P. Ex. 13 at 7. An incident report prepared
the following day says that he subsequently recanted, reporting that he purposely
sat down, but, because he had a headache, he told the staff that he fell and hurt his
head. P. Ex. 13 at 45-48.

A nurse’s note, dated November 24, 2008, at 5:00 p.m., indicates that R13
ambulates using a walker. His current behavior includes throwing himself on the
floor, but he is “easily redirected verbally.” He also has constant crying episodes.
CMS Ex. 20 at 61.

On the same day, a note was added to his August 28, 2008, MDS (minimum data
set): “resident constantly throws self to ground.” CMS Ex. 20 at 26.

According to a separate form, dated the same day, no injuries were noted. The
form asks whether fall/restraint risk assessments have been performed or are
needed, but the section is left blank. P. Ex. 13 at 49.
7

Another report from Geriatrics Associates of America, dated November 24, 2008,
indicates that nursing requested an evaluation following a fall. It mentions
lethargy and suggests that, if falls persist, the resident be referred for further
evaluation. Again, the report includes no mention of restraints. P. Ex. 13 at 76.

Entries to R13’s care plan, dated November 24, 2008, add to the problem list
“throws self to the floor.” Although difficult to read, an additional intervention
says “intervene and redirect if resident throws self on floor,” assess for bruises and
other injuries as needed. CMS Ex. 20 at 75, 76.

An incident report, prepared November 25, 2008, says only that future episodes of
throwing himself to the floor could cause injuries and that the resident was
encouraged to ask for assistance as needed. The incident report says nothing about
restraints. P. Ex. 13 at 50-53.

Nevertheless, that same day, November 25, 2008, a telephone order calls for geri-
chair with pelvic restraint for 24 hours, release for ten minutes every two hours for
resident safety. CMS Ex. 20 at 52.

A telephone order, dated November 28, 2008, again calls for geri-chair for 24
hours, release for ten minutes every two hours for resident safety. CMS Ex. 20 at
52.

At 8:00 a.m. on November 29, 2008, a nurse’s note describes R13 as “sitting on
wheelchair [and] throwing himself onto the floor” without visible injuries. After a
call to his physician’s office, he is restrained in a geri-chair with a pelvic restraint.
CMS Ex. 20 at 62.

In a separate report, no recommendation for “fall/restraint assessments” is
checked. CMS Ex. 20 at 72.

A telephone order from Dr. Rapp (Keith Rapp, M.D., C.M.D.), dated November
29, 2008, at 8:00 a.m., calls for geri-chair with pelvic restraint for 24 hours,
release every two hours for 10 minutes for resident safety. CMS Ex. 20 at 51.

A nurse’s note, dated December 4, 2008, at 9:30 p.m., says that R13 attacked a
nurse aide, “blindsiding her [and] throwing himself on top of her [and] refusing to
get up [and] holding her down.” Staff administered a shot of Ativan and,
according to the note, put R13 in the geri-chair due to “lack of safety awareness.”
CMS Ex. 20 at 62. He apparently went to sleep in the chair and, at 2:00 a.m., staff
put him to bed. CMS Ex. 20 at 62.
8

An incident report, dated December 4, 2008, says that R13 had a bruise on the
right side of his forehead. When asked what happened, he said that he must have
fallen, but then when asked if he had fallen, he said “I don’t know.” P. Ex. 13

at 54.

A separate form describes the incident and says again that no fall or restraint
assessment is needed. CMS Ex. 20 at 71.

According to the final disposition report, dated December 8, 2008, “no orders
were received,” but the psychiatrist recommended Veterans’ Administration (VA)
hospitalization if his self-injurious behavior continued. P. Ex. 13 at 55,57.

Notwithstanding the report’s assertion of no new orders, a December 4, 2008,
telephone order from Dr. Rapp authorizes a geri-chair with pelvic restraint for 24
hours, release every ten minutes for resident safety. CMS Ex. 20 at 51. Also
confusing, in light of the final disposition report, a note indicates that R13 was
apparently transported to the VA hospital at noon on December 4. P. Ex. 13 at 9.
See also CMS Ex. 20 at 50 (physician telephone order to send to VA for
evaluation and treatment).

That R13 subsequently went to the VA hospital is certain, although the record is not
altogether clear as to when he went. Some of the notes suggest he was transferred on
December 4, 2008, but nurses’ notes for December 5 place him at the facility, anxious
and tearful, asking to go to the hospital. His physician approved transfer to the VA
hospital. CMS Ex. 20 at 63.

While at the VA, staff noted that R13 tried to throw himself out of bed, tried to get out of
bed by himself, and had an unsteady gait. According to records dated December 14 and
16, 2008, the VA’s intervention was to “maintain close observation for safety,” which
apparently had “prevented [him] from falling.” The plan was to continue close
observation. He was also given an extra low bed. P. Ex. 13 at 113, 115-16.

R13 was re-admitted to the facility on December 17, 2008. A nurse’s note
describes new and old bruising, characterizes R13 as confused and wandering,
with “several redirection attempts needed to complete assessment.” CMS Ex. 20
at 55.

A December 17, 2008, telephone order, attributed to Dr. Rapp, says “place in
[geri-chair with] pelvic [for 24 hours due to] lack of safety awareness. CMS Ex.
20 at 49.

A physical therapy screening form refers to R13 as “status post fall December 17,
2008,” and contains the following note from a physical therapy assistant:
“Resident ambulated out of his room [and] into middle of hallway [and] let
himself fall backwards. Resident put in geri-chair [with] pelvic restraint due to
9

lack of safety awareness.” CMS Ex. 20 at 98-99. The form says nothing about
whether he could benefit from therapy.

An incident report says that he ambulated out of his room to the middle of the
hallway and let himself fall backward. He voiced no complaints of pain or
discomfort, although he suffered a hematoma. P. Ex. 13 at 58. The report lists
physician orders to monitor for pain and perform neurological checks; it says
nothing about any order for restraints. P. Ex. 13 at 59.

A separate report describes the incident and again says, remarkably, that “no
fall/restraint assessment needed.” CMS Ex. 20 at 70.

At 2:00 a.m. on December 18, 2008, a nursing note describes the resident as “up
in geri-chair” due to throwing himself to the floor. CMS Ex. 20 at 55.

A physician telephone order dated December 18 calls for “skull series.” CMS Ex.
20 at 49.

An incident report, dated December 22, 2008, says that at 8:15 p.m., R13 was
walking down the hall toward the nurses’ station, when he “threw” himself
forward. He broke his fall with his palms and knees, but hit the left front of his
forehead, sustaining two hematomas. Redness was also noted on his palms and
knees, but he voiced no pain or discomfort. He was sent to the VA hospital for a
computerized tomography (CT) scan and skull x-rays. P. Ex. 13 at 60, 61; CMS
Ex. 20 at 47.

Another document describes the incident and indicates that a fall assessment (but
not a restraint assessment) is needed. CMS Ex. 20 at 69.

The final disposition report says that the resident continues to require staff
reevaluation related to self-injurious behavior and mentions that the family is
supportive, with increased visits and telephone calls. It also says that the care plan
team has been notified, and physicians have or will review medications. P. Ex. 13
at 63. Again, the report says nothing about physical restraints.

R13 was released from the VA on December 29, 2008, and returned to the
facility. Kevin McNamara, M.D., his physician at the VA, noted his agitation and
aggressiveness, but called for medication, close observation, and “restraints only if
absolutely necessary.” P. Ex. 13 at 93.

A readmission report says no behavior problems reported and indicates that he was
using a wheelchair at the time of readmission. P. Ex. 13 at 64. When he stood up
from the wheelchair, a nurse’s note indicates that he was redirected to sit on the
bed, and he complied. But he apparently attempted again to throw himself on the
floor, so was placed in restraints in a geri-chair “for lack of safety awareness.”
10

CMS Ex. 20 at 57. A form titled “nursing comprehensive admission data” dated
December 29 indicates, under a section titled “ADL” (activities of daily living)
that the resident uses a wheelchair and a geri-chair, but does not explain why. It
says nothing about behaviors or restraints. P. Ex. 13 at 1-4.

A report from Geriatric Associates of America dated December 29, 2008, finally
mentions his behavior and says “safety, geri-chair [with] pelvic restraint.” P. Ex.
13 at 77.

On December 29, 2008, use of a geri-chair with pelvic restraint is added to R13’s
care plan as an intervention to address falls and related injuries as well as
dementia. CMS Ex. 20 at 75-76. His readmission orders also call for a geri-chair
with pelvic restraint, listing the reason as “lack of safety awareness.” The order
instructs staff to “release and reposition” every two hours for ten minutes. CMS
Ex. 20 at 42. Nevertheless, on December 29 (time is not indicated), staff also
obtained a telephone order authorizing geri-chair with pelvic restraints due to lack
of safety awareness. CMS Ex. 20 at 46.

At 2:00 p.m. on December 31, 2008, he is up in his geri-chair with a pelvic
restraint, according to the nursing note. No justification for the restraint is offered.
In fact, the note says “no [signs or symptoms] of distress.” CMS Ex. 20 at 57.

A nursing note dated January 1, 2009, at 8:00 p.m. describes R13 as up in a geri-
chair with pelvic restraint. When released after two hours, he attempts to throw
himself to the floor. CMS Ex. 20 at 58.

At 2:00 a.m. on January 2, 2009, according to the nurse’s note, he is again in the
geri-chair, because of attempts to throw himself to the floor. He asked to go to
bed, and staff put him in bed, but he attempted to throw himself to the floor. So, at
2:15 a.m., staff restrained him in the geri-chair. CMS Ex. 20 at 58.

At 5:00 a.m., staff noticed increased bruising on R13’s forehead. When asked
about it, he said that he “slipped.” Subsequent entries for the day describe him as
restrained in a geri-chair, and say that, when released, he tried to throw himself to
the floor. CMS Ex. 20 at 58.

At 3:00 a.m. on January 3, 2009, according to the nurse’s note, R13 is up ina
geri-chair. CMS Ex. 20 at 59.

On January 4, 2009, he is in the geri-chair due to trying to throw himself to the
floor. CMS Ex. 20 at 59.

A nurse’s note and an incident report dated January 5, 2009, indicate that R13
was throwing himself to the floor, but provides no additional information. P. Ex.
13 at 66; CMS Ex. 20 at 59. On the incident report, “fall risk assessment” is
11

checked (although not initialed), which appears to mean that one is necessary.
CMS Ex. 20 at 68."

Skull x-rays were negative. According to the report, the resident “is now wearing
a soft helmet” and staff and family continue to assist as needed. P. Ex. 13 at 66-
67. The report says nothing about restraints.

A second report “prepared in anticipation of litigation,” says that at 3:30 a.m., he
threw himself to the floor, hitting the top and side of his head. P. Ex. 13 at 68.

On January 9, 2009, a social worker’s psycho/social assessment notes that the
resident has been throwing himself out of bed, and injuring himself. She notes
that his family is supportive, and that social work will follow as needed. The note
does not mention restraints. P. Ex. 13 at 80.

An MDS completed January 9, 2009, identifies socially inappropriate/disruptive
behavioral symptoms exhibited within the previous week that were “not easily
altered.” It says that he requires a one-person physical assist for most activities of
daily living. CMS Ex. 20 at 18. The form indicates that a trunk restraint and chair
to prevent rising are used daily. CMS Ex. 20 at 21. It refers to nursing notes to
document behavioral symptoms and use of restraints. CMS Ex. 20 at 24.

R13’s success in flipping over himself and the geri-chair while restrained. Undisputed

evidence establishes that by mid-January, R13 was capable of flipping himself over —
chair and all -- while restrained in his geri-chair:

On January 10, 2009, at 10:00 a.m., a nurse’s note describes R13 as “yelling” and
“throwing himself backwards into his geri-chair repeatedly.” When verbal
redirection proved ineffective, he was given a shot of Ativan. CMS Ex. 20 at 64.

On January 13, 2009, staff found R13 “on [the] hallway” at 2:00 a.m. He said
that he was not sleeping. A nurse aide restrained him in a geri-chair “to prevent
any possible injuries.” CMS Ex. 20 at 64. But, at 2:15, he began a new and very
dangerous behavior. According to the nurse’s note, he attempted to flip the geri-
chair by grabbing the hall side rails. Staff gave him an injection of Ativan. CMS
Ex. 20 at 64. At 2:30 a.m., he again attempted to flip the geri-chair. Staff describe
him as “sitting in” the geri-chair, then leaning forward and pushing back,
“attempting to flip [the] chair backward.” Staff reminded him that he could injure
himself. CMS Ex. 20 at 64. At 2:45 a.m., he “succeeded in his attempts”
(emphasis added). According to the note, his chair fell backward, with him still

* The form is curious because it allows staff to check that “no” restraint assessment is
necessary, but it does not provide a place to check that a restraint assessment is
necessary.
12

restrained in it. Fortunately, he suffered no injuries. He was given an injection of
Haldol “for extreme agitation.” CMS Ex. 20 at 64-65.

R13 thus demonstrated that he was capable of flipping himself over while restrained in a
geri-chair. This was a serious warning to facility staff that restraining him in a geri-chair
placed him in danger. At a minimum, they should have considered alternatives. Yet, no
one even filled out an incident report. No one investigated.° No one assessed this
significant change in the resident’s behavior. No interdisciplinary team or anyone else
amended his care plan to address the behavior. I see no evidence that they even told
R13’s attending physician. Indeed, in his declaration, Dr. Rapp indicates that he ordered
R13 restrained in a geri-chair “in direct response to the resident’s ability to tip the
wheelchair.” P. Ex. 6 at 1 (Rapp Decl. 43). He does not claim that it was appropriate to
restrain R13 in a geri-chair after R13 showed that he could also flip over that type of
chair.”

And staff continued to restrain R13 in a geri-chair:

e At 4:00 a.m. on January 15, 2009, R13 was again trying to jump out of bed and
was striking out at staff. They placed him in a geri-chair with pelvic restraints.
CMS Ex. 20 at 65.

e At 2:00 a.m. on the morning of January 16, 2009, he was trying to get out of bed,
so they “placed [him] in [a] geri-chair for lacking of safety awareness.” CMS Ex.
20 at 65.

e At what appears to be 5:00 a.m. on January 18, 2009, he was in his geri-chair
wearing protective head gear. He again “leaned forward, then quickly pushed

> Petitioner asserts generally that staff “performed a complete investigation and
completed incident reports following each incident,” but then cites only to reports of the
incidents occurring November 18 and 24, December 4, 17, and 22, and January 5 and 21.
Petitioner offers no reports for this incident or the one occurring on January 18 (discussed
below). P. MSJ Br. at 22. Moreover, as this discussion shows, none of the cited reports
evidence a “complete investigation.” See Century Care of Crystal Coast, DAB No. 2076
at 21 (2007), aff'd, No. 07-1491, 2008 WL 2385505 (4th Cir. 2008) (by not investigating,
the facility loses an opportunity to analyze and correct its problems).

® T recognize that I must draw every reasonable inference in the light most favorable to
Petitioner. From Dr. Rapp’s conspicuous silence on the issue, I could infer that staff did
not inform him that R13 was able to flip himself over while restrained in a geri-chair. Or,
I could infer that staff told him, and he nevertheless continued to renew the restraint order
whenever staff requested, without regard to the dangers posed. Inasmuch as Dr. Rapp is
the facility’s medical director, neither inference seems more favorable to Petitioner. P.
Ex. 6; CMS Ex. 7 at 9. In any event, the physician’s willingness to issue the order does
not absolve the facility of its duty to provide R13 with the services necessary to protect
him from harm.

13

back[,] flipping the G-chair back.” He fell on top of the chair’s padding. He was
placed on one-on-one supervision for the remainder of the shift. CMS Ex. 20 at
65. Notes indicate that, at 2:00 in the afternoon of January 18, he was in the geri-
chair wearing protective headgear. CMS Ex. 20 at 65.

Thus, for a second time, R13 showed himself capable of flipping over while restrained in
his geri-chair. While providing him with one-on-one supervision for the remainder of the
shift was probably a good idea, staff did not address the underlying problem, which was
that R13 could no longer be considered safe while restrained in a geri-chair. Again, I see
no evidence of an incident report, investigation, interdisciplinary team meeting, or care

plan changes.

A note dated January 20, 2009, at 8:00 a.m., says that he “continues to throw self
on ground in an attempt to hurt self.” In the office of the Director of Nursing, he
threw himself onto his knees, and old scabs started bleeding. CMS Ex. 20 at 66.

A nurse’s note dated January 21, 2009, 10:30 p.m., says that R13 was trying to
jump out of bed, so staff placed him in a geri-chair with pelvic restraints, and then
put him in the “B” dining room. At 11:00 p.m., a nurse at the nurses’ station
“heard a loud thump.” She found R13 on the floor, lying on his back still
restrained in the geri-chair, wearing a helmet. Staff noted seizure activity; his
pupils were dilated and non-reactive to light. Staff called Emergency Medical
Services (EMS), and he was taken to the emergency room. P. Ex. 13 at 14; CMS
Ex. 20 at 67.

A physician’s telephone order indicates that, at 10:30 p.m., staff “may place in
geri-chair for 24 [hours] [due to] lack of safety awareness.” CMS Ex. 20 at 45. At
11 p.m., another telephone order says “notify EMS.” CMS Ex. 20 at 45.

A very puzzling incident report says nothing about the restraint, but reports that
“Charge Nurse Della Pinder stated ‘resident had a [seizure]’” but was uninjured
“due to the protection of the tall padded back of [the geri-chair] and helmet.” P.
Ex. 13 at 72. Nevertheless, the report also says that staff called EMS, and sent the
purportedly uninjured resident to the hospital. P. Ex. 13 at 72. The report
mentions R13’s history of throwing himself on to the floor, notes that he continues
to wear a helmet, and “receives staff redirection” as needed, and “‘is afforded the
use of a geri-chair for protection.” With respect to the particular incident, it says
that on January 21 at 10:30 p.m., R13 attempted to throw himself from his bed, but
staff were “able to intervene.” It mentions, without further explanation, that the
restraint committee would meet prior to R13’s readmission. P. Ex. 13 at 73.

And apparently some misinformation made its way to the VA hospital. Trauma
staff there understood that R13 had been sitting in his chair and fell to the ground.
He was found unresponsive and had one episode of seizure-like activity. The
trauma note indicates “difficult to assess whether this was a witnessed fall or not.”

14

CMS Ex. 20 at 10. A CT scan revealed a subdural hematoma, and he was
admitted to the intensive care unit. CMS Ex. 20 at 10. The neurosurgeon
described the injury as “traumatic.” CMS Ex. 20 at 12. He was subsequently
removed from his ventilator and died on January 25, 2009. CMS Ex. 20 at 13.

Petitioner concedes that R13 “was placed in a geri-chair with a pelvic restraint for
safety,” and “[a]fter hearing a noise,” a licensed vocational nurse (LVN) “assessed [him]
to be ‘on his back with [geri-chair] and restraint and helmet on’ and non-responsive.” P.
MSJ Br. at 20-21. Although silent on some of the additional details, Petitioner has not
come forward with evidence to challenge CMS’s assertions that: 1) staff put the
restrained resident “in the B dining room”; or 2) no staff person witnessed the incident.
Petitioner also concedes that staff immediately called EMS, and transferred R13 to the
hospital, where he was diagnosed with a subdural hematoma and died on January 25,
2009. P. MSJ Br. at 21.

On the other hand, Petitioner makes the following assertions, which have little or no
support in the record:

e Citing the nurse’s note (CMS Ex. 20 at 67) Petitioner asserts that R13’s “head
never hit the floor.” P MSJ Br. at 22. The note says that R13 was found “on the
floor, on his back [with the] geri-chair [and] restraint on [and] helmet on.” CMS
Ex. 20 at 67.

e Without any citation to the record, Petitioner asserts that “[t]he resident was in
direct line of observation of the LVN at the nurses’ station,” and that his “geri-
chair likely tipped backwards as the resident experienced a seizure and the resident
was admitted to the hospital. The circumstances of the event were observed and
recorded.” P. MSJ Br. at 25.

e Citing generally to Dr. Rapp’s declaration, Petitioner suggests that the “geri-chair
may have tipped backwards as a result of the resident’s seizure.” P. MSJ Br. at 22.

With respect to whether R13’s head hit the floor, although the nurse’s note is far from
definitive, for summary judgment purposes, I accept Petitioner’s inference that R13’s
head did not actually hit the floor. Nevertheless, the undisputed evidence demonstrates
that:

1) R13 had no history of a seizure disorder;

2) until this incident, he had not displayed any seizure-like activity;

3) immediately after the incident, the nurse observed seizure-like symptoms; and
4) R13 was subsequently diagnosed with a subdural hematoma.

Accordingly, the only reasonable inference is that the geri-chair and soft helmet did not
provide sufficient protection and that he injured his head.
15

Petitioner’s claims that R13 was in “direct line of observation” of the nurse and that the
circumstances “were observed” are not supported by any evidence in this record. No
staff member has come forward claiming to be a witness. Neither the nurse’s note nor
the incident report identifies any witness to the event. The nurse’s note says that staff put
R13 in the dining room and responded, because the nurse heard (but did not see) the
incident. Moreover, in defending the facility’s failure to investigate and to notify the
Texas State Agency of this incident, Petitioner inconsistently argues that, under state
rules, “an unwitnessed fall is not a reportable event,” which seems to concede that no one
witnessed R13’s accident. P. MSJ Br. at 24.”

Finally, the suggestion that a seizure, rather than R13’s well-documented behaviors,
caused the geri-chair to flip is neither supported by any of the evidence nor a reasonable
inference. Dr. Rapp’s declaration does not mention the January 21 incident and says
nothing about seizures. P. Ex. 6 (Rapp Decl.). No evidence in the record suggests that
R13 had ever had a seizure before he suffered that head injury on January 21.

But even if I accepted all of Petitioner’s unsupported assertions and unreasonable
inferences, I would find them not material. My finding of substantial noncompliance
does not turn on whether R13 hit his head on the floor, nor on whether he had a seizure
before or after his head injury. From at least January 13 on, staff were on notice that R13
could and would flip over his geri-chair. The facility was not in substantial compliance,
because, knowing that R13 engaged in such dangerous and self-injurious behavior, they
continued to restrain him without taking appropriate precautions to ensure his safety. On
the night of January 21, they so restrained him, and left him in a dining room. This was
neglect and posed the potential for more than minimal harm.

R13 was not the only resident who was regularly restrained in a geri-chair, even after he
proved himself capable of overturning it.

Resident 3. The facts regarding Resident 3 (R3) are undisputed. He was admitted to the
facility on December 20, 2007, with diagnoses of Alzheimer’s disease, dementia with
delusions, and hypothyroidism. At the time of the survey, he was 68-years old. CMS Ex.
latl.

7 Petitioner allows for an exception to its “unwitnessed fall” rule: if the fall results in
death, it must be reported and investigated. But Petitioner also points out that when the
surveyors arrived at the facility, R13 was not yet dead. P. MSJ Br. at 24. I do not accept
Petitioner’s interpretation of state law, and, in any event, federal regulations required
reporting and investigation of the incident. 42 C.F.R. § 483.13(c)(2) and (3); see Century
Care of Crystal Coast, DAB No. 2076 (2007), aff'd, No. 07-1491, 2008 WL 2385505
(4th Cir. 2008) (Professional standards of quality require that incidents be reported and
investigated.) Certainly, any time a fall is followed by significant symptoms of serious
injury and hospitalization, it must be reported and investigated.
16

A physical restraint assessment form, dated January 8, 2008, suggests restraining R3 in
order to maintain posture and decrease falls. CMS Ex. 11 at 5. The same day, his
attending physician, Dr. Lira, ordered a geri-chair with tray when out of bed due to “lack
of safety awareness.” CMS Ex. 11 at 16. In a psychiatric consult, dated January 8, 2008,
Dr. Valdez indicates that she reviewed the chart and talked to staff. She writes that,
according to staff, R3 is “restless, easily angered [and] agitated.” He sleeps poorly, is
confused, anxious, worried, paranoid, and delusional. Dr. Valdez recommended
medication changes, but her report does not mention physical restraints. P. Ex. 3 at 22-
23.

A nurse’s note indicates that, on January 18, 2008, R3 attacked one of the nurse aides.
Staff responded with medication, and, when he refused to stay in bed, they transferred
him to a geri-chair. P. Ex. 3 at 3. According to the notes, at 4:00 a.m., he was found
trying to get into bed with his roommate. Staff put him in a geri-chair with a tray
restraint, citing “lack of safety awareness.” P. Ex. 3 at 3.

A physician’s order, dated February 21, 2008, calls for pelvic restraint in a geri-chair
when out of bed due to “lack of safety awareness [related to] dementia.” Release every
two hours. P. Ex. 3 at 4. On March 11, 2008, Dr. Lira apparently amended the order and
called for a pelvic restraint while in a wheelchair when out of bed. P. Ex. 3 at 5.

Physician progress notes, dated February 20, March 7, and March 12, 2008, indicate
that Dr. Valdez reviewed the chart and discussed with staff the resident’s paranoia,
delusions, anxiety, and agitation. She increased the resident’s medications, but, again,
her report does not include physical restraints as part of the “plan.” P. Ex. 3 at 6-9.

An April 8, 2008, progress note indicates that Dr. Valdez again discussed R3’s chart with
facility staff who reported that R3 was “very agitated, anxious, [and] restless in his geri-
chair -- to the point that he knocks himself [and] the geri-chair over to the floor’®
(emphasis added). The physician’s subsequent plan includes medication changes and lab
work, but does not mention physical restraints. P. Ex. 3 at 10-11.

On April 9, 2008, another physician renewed R3’s order for a geri-chair with pelvic
restraint when out of bed, citing restlessness, dementia, and lack of safety awareness.
CMS Ex. 11 at 17.

Between April and November 2008, additional physician progress notes mention R3’s
symptoms and medication changes, but none of them talk about physical restraints or the
resident’s ability to overturn his geri-chair. P. Ex. 3 at 12-16.

5 T note that, except for this note, the record contains no evidence that, prior to November
12, 2008, facility staff investigated or reported any instances of R3 overturning his geri-
chair while restrained.
17

The record also includes versions of a care plan indicating that use of a geri-chair with
table top and use of a geri-chair with pelvic restraint were added to the plan, but the
entries are dated in such a jumbled way that I am not able to determine when that
occurred. CMS Ex. 11 at 8-10. In any event, notwithstanding Dr. Valdez’s April 8 note
that R3 “knocks himself and the geri-chair over to the floor,” the care plan does not
describe or address that dangerous behavior.

A cryptic note says that on November 12, 2008, while in his geri-chair, R3 was “noted to
have fallen backward.” He suffered no injuries. CMS Ex. 11 at 19. The report offers no
additional information. Sections on the form regarding referrals and assessments are left

blank. An incident report only repeats the same information (or lack of information). P.

Ex. 3 at 18. No further investigation was conducted, and no interdisciplinary team met to
consider this development. No changes were made to the resident’s care plan. Physician
notes, dated November 19, 2008, do not mention the incident or R3’s physical restraints.

P. Ex. 3 at 17.

Thereafter, facility staff continued to restrain R3 in a geri-chair, using the pelvic restraint.
A second report, dated November 24, 2008, indicates that R3 was again “noted” to be
lying on the back of the chair, “chair being flipped backwards.” CMS Ex. 11 at 18.
Again, the sections of the form relating to referrals and assessments are left blank, and
the facility took no additional action to address the problem. An incident report includes
the same information. P. Ex. 3 at 20-21.

On January 24, 2009, one of the surveyors observed R3 in the hallway restrained in a
geri-chair by means of a pelvic restraint. He was repeatedly raising his legs, pushing off
the wall, causing the chair’s front legs to lift. CMS Ex. 8 at 7.

Petitioner does not dispute any of this, but argues that the regular physician assessments
and multiple changes in the resident’s care plan were sufficient to satisfy the regulations.
Petitioner also points to R3’s behaviors and suggests that restraining him in a geri-chair
was safer than allowing him to walk, because “[h]e would often run, staggering down the
hall, oblivious to other residents and to other hazards,” as well as safer than restraining
him in a wheelchair, which “he would have flipped.” P. MSJ Br. at 9-10.

Even accepting (for summary judgment purposes) that facility staff chose an intervention
that was safer than others might have been, when that intervention proved dangerous,
they were obligated to consider alternatives. But, even though R3’s care plan notes that
he “flips over” the geri-chair, facility staff did not even consider ways to address that
dangerous behavior until the time of the survey. CMS Ex. 11 at 9 (a note, dated January
25, 2009, says discontinue the restraint; a note, dated January 26, 2009, calls for 1:1
supervision).

Staff put R3 in harm’s way whenever they restrained him in a geri-chair -- knowing that
he was able to overturn it — without taking precautions to ensure his safety. They were
thus not providing him the services “necessary to avoid physical harm” and were guilty
18

of neglect. I find this ongoing practice particularly disturbing here since staff were doing
it on January 24, just days after R13 had suffered his subdural hematoma while restrained
in the same fashion.

Resident 4. Again, the facts surrounding Resident 4 (R4) are not in dispute. He was re-
admitted to the facility on August 25, 2008. CMS Ex. 12 at 1.” He was 57-years-old,
suffering from Parkinson’s disease and dementia. CMS Ex. 12 at 5. He also had a long
history of schizophrenia and depression. P. Ex. 4 at 25. At 5:00 a.m. on August 26, Dr.
Lira ordered R4 placed in a geri-chair with a pelvic restraint when out of bed due to “lack
of safety awareness related to Parkinson["]s.” He was to be checked every hour and
released every two hours for ten minutes. CMS Ex. 12 at 1. CMS alleges that no
restraint assessment accompanied the order, and Petitioner has neither produced an
assessment nor claimed to have performed one.

Physician notes, dated August 28, September 10, and September 12, 2008, describe R4 as
“totally demented,” paranoid, anxious, delusional, agitated, restless, and aggressive. Dr.
Valdez includes a plan in her notes, which describes medication changes, but, again, does
not mention physical restraints. P. Ex. 4 at 15-16.

At 5:25 p.m. on September 20, 2008, according to the nurses’ notes, staff “heard a
noise” and found R4 on the floor on his left side, still restrained in the geri-chair. No
injuries were noted. CMS Ex. 12 at 2. Staff paged Dr. Lira, who did not return the call.
They called Dr. Valdez, who did not answer and did not have voice mail, so they were
unable to leave a message. At 11:15 a.m. the following day, staff apparently reached Dr.
Valdez, who prescribed Ativan. The nurse’s note does not include any discussion of
physical restraints. CMS Ex. 12 at 2.

According to another note, at 12:15 p.m. on September 21, 2008, an agitated R4 “flipped
his] geri-chair over and fell” but sustained no visible injuries. Staff again called Dr.
Lira, who returned the call a couple of hours later but gave no new orders. CMS Ex. 12
at 2.

Physician notes, dated September 22 and 23 and October 29, 2008, mention the
resident’s anxious and aggressive behaviors and provide for more medication changes,
but they say nothing about the physical restraint employed, much less the risk of injury it
posed. P. Ex. 4 at 17-18.

A report, dated November 5, 2008, on Geriatrics Associates of America letterhead notes
that R4 is at high risk of falls and injury. He is “in geri-chair, very restless — restrained
secondary to] risk of injury.” P. Ex. 4 at 23. The note does not mention a pelvic

° The record is murky as to R4’s earlier admission and discharge. He was apparently
admitted on July 4, 2008, discharged on August 22, and readmitted on August 25. P. Ex.
4atl.
19

restraint and, again, says nothing about the resident’s ability to flip over the geri-chair
and the risks of injury posed by the restraint itself.

Staff continued to restrain R4 in a geri-chair. On January 7, 2009, at 10:00 a.m., they
found him on the floor, his geri-chair tipped on the right side. An incident report
describes no injuries and offers no additional information. CMS Ex. 12 at 7. According
to surveyor notes, however, R4 injured his shoulders, and Petitioner has not disputed that
fact. CMS Ex. 8 at 20; CMS MSJ Br. at 9.

Finally, at 6:00 p.m. on January 24, 2009, one of the surveyors observed R4 restrained
in a geri-chair; he was fidgeting and “would fling his legs over the . . . arm rests.” CMS
Ex. 8 at 6.

Again, Petitioner disputes none of this but points out R4’s significant behaviors as
justification for keeping him restrained. P. MSJ Br. at 10-12. But the undisputed
evidence establishes that R4 could not safely be restrained in a geri-chair. Yet, knowing
that he was capable of overturning the geri-chair, staff made no plans and took no
precautions to keep him safe.

Resident 5. The parties also agree about the facts surrounding Resident 5 (R5). He was
admitted to the facility on November 14, 2007. CMS Ex. 8 at 15. A restraint assessment,
dated January 9, 2008, says that he has a history of falls, is unable to comprehend safety
instructions, and needs a restraint to “[increase] socialization.” CMS Ex. 13 at 1. His
care plan was amended to add “pelvic restraint while in [geri-chair]. Release and
reposition [every two hours and as needed].” CMS Ex. 13 at 3. On April 10, 2008, R5
was “found sitting on floor [with geri-chair] tipped on one side.” The pelvic restraint was
still attached to the resident and to the chair, although it had been loosened. CMS Ex. 13
at 4. Again, the facility was on notice that R5 was able to tip himself over while
restrained, yet staff took no precautions to keep him safe. They did not even review his
assessment until November 25, 2008, more than seven months after he demonstrated that
he could tip himself over while restrained in a geri-chair. CMS Ex. 13 at 1.

Thus, the undisputed evidence establishes that, from at least as early as April 2008 until
the time of the survey, staff regularly restrained these residents in geri-chairs. Staff
knew, or should have known, that it was a dangerous practice, because these individuals
were capable of tipping or flipping themselves over while so restrained. And yet, the
facility did not timely assess the safety of its practice nor initiate interventions to ensure
resident safety. When incidents occurred, staff failed to investigate adequately. The
facility therefore failed to implement policies and procedures that prohibit resident
neglect, and was not in substantial compliance with 42 C.F.R. § 483.13(c).'°

'° Because I find that the deficiencies involving the residents discussed above more than
justify the minimal penalties imposed, I do not discuss every resident CMS identifies as

at risk under 42 C.F.R. § 483.13(c), nor all of the incidents cited. See Grace Healthcare
of Benton, DAB No. 2189 at 5 (2008).
20

B. CMS is entitled to summary judgment that the facility was not in substantial
compliance with 42 C.F.R. § 483.13(a), because the undisputed facts establish
that the facility imposed physical restraints that were not required to treat the
resident’s medical symptoms.

The use of restraints is associated with numerous negative outcomes, such
as emotional desolation, agitation, fractures, chafing, burns, nerve damage,
circulatory impairment, decubitus ulcers, strangulation, and death.

Cross Creek Health Care Center, DAB No. 1665 at 6 (1998), citing 57 Fed. Reg. 27,
397, 27, 398 (June 19, 1992). Driven by such concerns, Congress explicitly required that
skilled nursing facilities protect and promote the rights of each resident “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.” Restraints may only be imposed
“to ensure the physical safety of the resident or other residents,” and, except in an
emergency, only upon the written order of a physician that “specifies the duration and
circumstances under which the restraints are to be used.” Act § 1819(c)(1)(A)(ii).

By regulation, CMS has implemented the statutory provision:

The resident has 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). As the Departmental Appeals Board has noted, this regulation
imposes on the facility an independent obligation to ensure that its use of restraints, even
with a doctor’s order, meets the regulatory criteria. The facility must “continue to assess
the impact of the use of a restraint and to consult with the doctor if [it] finds that use of
the restraint no longer meets the criteria of the regulation.” Cross Creek, DAB No. 1665
at 11. The mere existence of the doctor’s order does not presumptively establish that the
facility is complying with the requirements of the statute or regulation. Cross Creek,
DAB No. 1665 at 12, n.9.

The parties do not disagree as to what policies and procedures a long-term facility must
have in place in order to comply with the regulation. Petitioner has come forward with
what it identifies as the facility policy on restraint (P. Ex. 14), and its provisions echo
those sections of the State Operations Manual, relied on by CMS.'! See CMS Ex. 29; see
also CMS Ex. 21 at 1-5. For summary judgment purposes, I accept as true that

'' Tn the State Operations Manual, CMS provides guidance to state survey agencies on
procedures and regulatory criteria relating to the Medicare certification of long term care
facilities and other providers.
21

Petitioner’s proffered document encompasses the facility’s written policies and
procedures governing its use of restraints.

The policy recognizes that “[i]n practice, restraints have many negative side effects and
risks that, in some cases, far outweigh any possible benefit that can be derived from their
use.” P. Ex. 14 at 5.

In this case, Petitioner justifies the facility’s extensive use of restraints by pointing to the
“unique” character of its population, the majority of whom “suffer from major
depression, psychotic disorders. . . and/or dementia with major behavioral features,” and
many of whom are “also mentally impaired.” P. MSJ Br. at 4. In fact, as Petitioner’s
policy explains, the facility has a heightened obligation to employ restraints judiciously
when caring for the cognitively impaired.

Residents who are cognitively impaired are at a higher risk of entrapment
and injury or death caused by restraints. Jt is vital that restraints used on
this population be carefully considered and monitored. In some cases, the
risk of using the device may be greater than the risk of not using the device.

P. Ex. 14 at 3 (emphasis added). Thus, prior to employing any restraint,

the facility must assess the resident to properly identify the resident’s needs
and the medical symptom that the restraint is being employed to address.

P. Ex. 14 at 5 (emphasis added). See Lakeridge Villa Health Care Center, DAB No.
1988 (2005) ([A] facility must properly document that its staff assessed the resident for
restraint use prior to calling the resident’s physician requesting an order, and that the
specific medical symptom cannot be addressed by another less restrictive intervention.).

The undisputed evidence establishes multiple instances in which the facility routinely
restrained its residents, without first performing the necessary resident assessment. In
addition to R13 and R4, discussed above,

e R7’s diagnoses included convulsion, Alzheimer’s disease, anxiety, and
schizophrenia. P. Ex. 7 at 1. The facility obtained physicians’ orders to restrain
him as early as May 2008 (P. Ex. 7 at 28), and use of a pelvic restraint with the
geri-chair was apparently added to his care plan on June 14, 2008. CMS Ex. 14 at
3. By August 2008, facility staff were regularly restraining him in a geri-chair.
Yet, the facility did not assess R7 for restrains until December 3, 2008. CMS Ex.
14 at 1.

e R9 was readmitted to the facility on October 15, 2008, and the parties agree that
he was restrained in a geri-chair, using a pelvic restraint, as early at October 2008.
CMS MSJ Br. at 12; P. MSJ Br. at 16; P. Ex. 9 at 5, 6, 12, 14; CMS Ex. 16 at 8.
Yet the pelvic restraint with geri-chair intervention was not added to his care plan
22

until December 23, 2008, and his restraint assessment form is dated January 2009.
CMS Ex. 16 at 1, 3-6.

The inadequate assessments were not the facility’s only shortcoming with regard to its
use of restraints. The facility’s treatment of R13 illustrates that the facility was not in
substantial compliance with 42 C.F.R. § 483.13(a) in other respects:

e Ihave already discussed how the facility regularly applied restraints without ever
having assessed the resident’s needs, symptoms, or whether his symptoms could
be addressed by less restrictive means.'? When staff prepared an incident report,
they simply ignored questions about the need for a restraint assessment, or said
that none was necessary. P. Ex. 13 at 45-49, 70-72.

e Staff invariably justified applying the restraints by pointing to R13’s “lack of
safety awareness,” even though they restrained him in response to his aggressive
and/or self-injurious behaviors. P. Ex. 13 at 6, 7; CMS Ex. 20 at 62.

e In responding to his behaviors, staff did not follow R13’s care plan. His
problematic behaviors began at least as early as November 5, 2008, and were
added to his care plan on November 24. But, as of November 24, staff were
instructed to “intervene and redirect” whenever R13 threw himself on the floor.
CMS Ex. 20 at 75, 76. Nothing in the care plan directed them to restrain him.
Yet, on November 29, December 4, December 17, December 18, and December
29, 2008, staff restrained the resident in response to his behavior. CMS Ex. 20 at
55, 57, 62, 98-99. On December 29, 2008, restraint in a geri-chair was finally
added to the resident’s care plan; however, the plan still says that staff should
attempt to redirect first.

e Isee no evidence that staff even regarded Dr. McNamara’s December 29, 2008,
order calling for “close observation” and “restraints only if absolutely necessary.”
P. Ex. 13 at 93.

e On some occasions, R13 is restrained without any documented justification, or for
reasons not justified by his care plan. For example, the nurse’s note for the
morning of January 13, 2009, does not describe any behavior other than the
resident’s wandering in the hallway. He did not become agitated until after he was

According to Surveyor Cyndia Kitt, RN, when staff could not produce a restraint
assessment for R13, the facility’s Director of Nursing (DON) explained that the
responsible nurse was not aware that he needed to do them. The DON also told Surveyor
Kitt that the restraint was “physician driven” and used when the resident demonstrated
injurious behaviors to himself or others. If allowed to propel himself in a wheelchair, “he
would be more difficult to monitor.” CMS Ex. 27 at 3 (Kitt Decl.). Petitioner has not
come forward with any evidence suggesting a dispute over the DON’s admissions. Of
course, even without the remarks, sufficient evidence justifies CMS’s actions.
23

restrained. CMS Ex. 20 at 64. On other occasions, no reason is given for the
restraint. CMS Ex. 20 at 57 (December 31, 2008); 59 (January 3, 2009); 64
(January 10, 2009); 65(January 15, 2009).

e lam deeply disturbed by the disconnect between R13’s January 9, 2009, MDS,
which indicates that the resident was restrained daily, and the rest of his record,
which suggests frequent, but not daily restraints. CMS Ex. 20 at 21.

Without any citation to the record, Petitioner claims to have “reduced” restraint
utilization by the time of the survey. P. MSJ Br. at 24. Inasmuch as the claim is
unsupported, I need not accept it. Although Petitioner provides a sign-in sheet for a
restraints meeting held December 23, 2008, that document does not support Petitioner’s
claim. It lists the topic discussed there as “Suggestions — steps to restraint reduction,” but
includes nothing else. No evidence even suggests that R13 or any other resident was
discussed. P. Ex. 13 at 127. According to Petitioner, the meeting’s purpose was “to
implement a plan to reduce restraints in the facility,” but nothing in that document, or any
other document in this record, suggests that staff developed or implemented such a plan
until after the survey.'> P. MSJ Br. at 23.

Thus, the undisputed evidence establishes that facility staff repeatedly imposed restraints
without any assessment. They regularly imposed restraints without considering
alternatives. They failed to follow resident care plans that called for other interventions,
rather than restraints. They imposed restraints for reasons other then that listed in the
physician order. For all of these reasons, the facility was not in substantial compliance
with 42 C.F.R. § 483.23(a).'4

C. The penalties imposed are not unreasonably high.

I next consider whether the CMPs are reasonable by applying the factors listed in 42
C.F.R. § 488.438(f): 1) the facility’s history of noncompliance; 2) the facility’s financial
condition; 3) factors specified in 42 C.F.R. § 488.404; and 4) the facility’s degree of
culpability, which includes neglect, indifference, or disregard for resident care, comfort,
or safety. The absence of culpability is not a mitigating factor. The factors in 42 C.F.R.
§ 488.404 include: 1) the scope and severity of the deficiency; 2) the relationship of the
deficiency to other deficiencies resulting in noncompliance; and 3) the facility’s prior
history of noncompliance in general and specifically with reference to the cited
deficiencies.

8 In fact, staff were more likely to add even more restraints whenever a restrained
resident suffered injury. See, e.g., P. Ex. 14 at 23 (noting that after resident suffered falls
while restrained in a geri-chair with a table top, staff added pelvic restraint).

‘Again, because I find that the deficiencies involving the residents discussed above
more than justify the minimal penalties imposed, I do not discuss every resident CMS
identifies as at risk under 42 C.F.R. §§ 483.13(a), nor all of the incidents cited.
24

In reaching a decision on the reasonableness of the CMP, I consider whether the evidence
supports a finding that the amount of the CMP is at a level reasonably related to an effort
to produce corrective action by a provider with the kind of deficiencies found, in light of
the above factors. I am neither bound to defer to CMS’s factual assertions, nor free to
make a wholly independent choice of remedies without regard for CMS’s discretion.
Barn Hill Care Center, DAB No. 1848 at 21 (2002); Community Nursing Home, DAB
No. 1807 at 22 et seq. (2002); Emerald Oaks, DAB No. 1800 at 9 (2001); CarePlex of
Silver Spring, DAB No. 1638 at 8 (1999).

Petitioner incorrectly asserts that CMS has imposed the “maximum daily penalty.” P.
MSJ Br. at 25. In fact, CMS has imposed two per-instance penalties: $5,000 for each of
the deficiencies discussed above. These penalties are in the middle of the range for per-
instance penalties ($1,000 to $10,000). 42 C.F.R. § 488.408(d)(iv). On the other hand,
they are extraordinarily modest considering what CMS might have imposed. See
PlumCity Care Center, DAB No. 2272 at 18-19 (2009) (even a $10,000 per instance
CMP can be “a modest penalty when compared to what CMS might have imposed”).

CMS has produced evidence, which Petitioner does not challenge, that the facility has a
history of noncompliance. According to Daniel J. McElroy, R.N., a nurse consultant
employed by CMS, “this is the ninth noncompliance cycle and the second enforcement
action” taken against the facility since October 20, 2004. CMS Ex. 28 at 6 (McElroy
Decl.).

With respect to the facility’s financial condition, Petitioner asserts, without explanation
or underlying support, that the $10,000 penalties place “a significant financial burden on
the facility.” P. MSJ Br. at 25. Of course, the burden should be “significant” or it is not
likely to produce corrective action. In any event, since Petitioner has not come forward
with any evidence regarding its financial condition, its opportunity to raise that issue has
been waived. Community Nursing Home, DAB No. 1807 at 15-16, 22 et seq.

With respect to the remaining factors, I consider the severity of the deficiencies

significant enough to warrant penalties muc
deficiencies did not stem from single, isolat
facility staff regularly imposed restraints in
They disregarded the instructions in resident
Knowing that residents were capable of flip
geri-chairs, staff continued the practice, wit

higher than those imposed here. These

ed instances. Among other transgressions,
the absence of assessments or care plans.

t care plans in order to restrain residents.

ping themselves over while restrained in their
hout even considering the dangers posed.

When accidents occurred, they failed to report or investigate in any meaningful way.

Based on these and the other facility practic
staff “neglect, indifference, or disregard” fo:
justifies the relatively minimal penalties im,

In light of the facility’s significant degree o

es discussed above, I find a high degree of
r resident safety. The facility’s culpability
posed.

f culpability, particularly with respect to R13,

the two $5,000 per instance penalties seem minimal.
25

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 restraints and neglect.
42 C.F.R. § 483.13(a) and (c). The penalties imposed were not unreasonably high. I
therefore grant CMS’s motion for summary judgment.

/s/
Carolyn Cozad Hughes
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Alpha Mobile Imaging, LLC,
Petitioner,
Vv.
Centers for Medicare & Medicaid Services.
Docket No. C-10-110
Decision No. CR2096

Date: March 23, 2010

DECISION

This matter is before me on the Centers for Medicare & Medicaid Services’ (CMS)
Motion for Summary Judgment. Petitioner, Alpha Mobile Imaging, LLC, opposes the
motion. | find that no material facts are in dispute and conclude that CMS’s position is
correct as a matter of law. I therefore grant CMS’s Motion and affirm CMS’s
determination to approve Petitioner’s Medicare participation effective May 26, 2009.

I. Background

Petitioner is a supplier of portable x-ray services in the greater Baton Rouge, Louisiana
area. On May 26, 2009, the Louisiana Department of Health and Hospitals (state agency)
conducted a survey of Petitioner to determine whether it was in compliance with
Medicare participation requirements for suppliers of x-ray services. CMS Ex. 1. The
state agency found that Petitioner met all requirements for Medicare participation on the
date of the survey, specifically finding that Petitioner was in compliance with 42 C.F.R.
Part 486, Subparts A-C, the conditions for coverage for suppliers of portable x-ray
services. Id. By letter dated June 8, 2009, CMS notified Petitioner that the effective date
of its Medicare participation was May 26, 2009, the date the state agency surveyed
Petitioner, as that was the earliest date that it determined that Petitioner met all
participation requirements.

By letter dated November 2, 2009, Petitioner requested a hearing. Petitioner asserted that
the effective date of its participation should be moved to July 10, 2008 (the date
Petitioner started to provide portable x-ray services to Medicare beneficiaries) due to the
state agency’s failure to timely notify Petitioner of a moratorium on surveys and other
circumstances beyond Petitioner’s control (but in CMS’s or the state agency’s control)
that unreasonably delayed the survey.

The case was assigned to me for hearing and decision on November 13, 2009. CMS filed
a motion for summary judgment (CMS Br.) on December 14, 2009, accompanied by
CMS exhibits (CMS Exs.) 1-3. Petitioner responded on January 26, 2010 (P. Br.),
accompanied by Petitioner’s exhibits (P. Exs.) 1-7. In the absence of objection, I admit
into evidence CMS Exs. 1-3 and P. Exs. 1-7.

II. Issues
The issues in this case are:
1. Whether summary judgment is appropriate; and

2. Whether CMS’s determination to approve Petitioner as a Medicare supplier
effective May 26, 2009, is correct as a matter of law.

Ill. Controlling Statutes and Regulations

Regulations at 42 C.F.R. Part 424, subpart P, govern the process for the enrollment of
providers and suppliers in the Medicare program. Completion of the enrollment process
is a prerequisite for a provider or supplier to bill and to receive payment for Medicare
covered services, to be granted Medicare privileges and to establish eligibility to submit
claims. 42 C.F.R. §§ 424.500; 424.505; and 424.502. To be enrolled, a provider or
supplier must meet the enrollment requirements specified in section 424.510(d), which
incorporates by reference additional compliance and reporting requirements in section
424.520. CMS is responsible for validating the accuracy of the information submitted as
part of the enrollment process, but uses Medicare contractors to verify information and to
recommend approval or denial to CMS.

With respect to the effective date of Medicare reimbursement, the enrollment regulations
incorporate by reference the regulation at 42 C.F.R. § 489.13, as well as other regulatory
provisions. 42 C.F.R. § 424.510(b). The preamble to the 2006 final rule explained that,

while CMS would not grant billing privileges until completion of the enrollment process
and approval of the enrollment application, the effective date for reimbursement of
Medicare covered services would continue to be determined based on current Medicare
regulations and policy based on the type of provider or supplier submitting the claims.
71 Fed. Reg. 20,754, 20,758 (April 21, 2006).

Part 489 of Title 42 applies generally to “providers” which must enter into provider
agreements to participate in Medicare. However, section 489.13 also applies to
“supplier” approval of entities such as portable x-ray services companies that, as a basis
for participation in Medicare, are subject to survey and certification by CMS or a state
agency. 42 C.F.R. § 489.13(a).

As a portable x-ray services company, Petitioner is designated a supplier under the Act
and regulations and has to meet all of the requirements of participation relevant to that
category of supplier. 42 C.F.R. Part 486, Subparts A-C. With regard to the effective date
of approval for Petitioner as a supplier, the regulations state that:

(b) All Federal requirements are met on the date of the survey. The agreement or
approval is effective on the date the survey . . . is completed, if on that date the
provider or supplier meets all applicable Federal requirements as set forth in this
chapter.

42 C.F.R. § 489.13(b).
IV. Summary Judgment

In Senior Rehabilitation and Skilled Nursing Center, DAB No. 2300 (2010), the
Departmental Appeals Board (Board) stated the standards for summary judgment:

Summary judgment is appropriate when the record shows that there is no genuine
issue as to any material fact, and the moving party is entitled to judgment as a
matter of law. Kingsville Nursing and Rehabilitation Center, DAB No. 2234, at 3
(2009), citing Celotex Corp. v. Catrett, 477 U.S. 317, 322-25 (1986). While the
Federal Rules of Civil Procedure (FRCP) are not binding in this administrative
appeal, we are guided by those rules and by judicial decisions on summary
judgment in determining whether the ALJ properly granted summary judgment.
See Thelma Walley, DAB No. 1367 (1992) .... The party moving for summary
judgment bears the initial burden of showing that there are no genuine issues of
material fact for trial and that it is entitled to judgment as a matter of law.
Kingsville at 3, citing Celotex, 477 U.S. at 323. If the moving party carries its
initial burden, the non-moving party must “come forward with ‘specific facts
showing that there is a genuine issue for trial.” Matsushita Elec. Industrial Co. v.
Zenith Radio, 475 U.S. 574, 587 (1986) (quoting FRCP 56(e)). 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 - - a fact that, if proven, would affect the outcome of the
case under governing law. /d. at 586, n. 11; Celotex, 477 U.S. at 322. In
determining whether there are genuine issues of material fact for trial, the reviewer
must view the evidence in the light most favorable to the non-moving party,
drawing all reasonable inferences in that party’s favor. U.S. v. Diebold, Inc., 369
USS. 654, 655 (1962). ... Whether summary judgment is appropriate is a legal
issue that we address de novo. Lebanon Nursing and Rehabilitation Center, DAB
No. 1918 (2004). In reviewing whether there is a genuine dispute of material fact,
we view the proferred evidence in the light most favorable to the non-moving
party. Kingsville at 4, and cases cited therein.

Senior Rehabilitation, DAB No. 2300, at 3. The Board has also noted that the role of an
administrative law judge (ALJ) in deciding a summary judgment motion differs from the
ALJ’s role in resolving a case after a hearing. The ALJ should not be assessing
credibility or evaluating the weight of conflicting evidence. Holy Cross Village at Notre
Dame, DAB No. 2291, at 4-5 (2009).

V. Findings of Fact and Conclusions of Law
1. The case can be decided based on CMS’s motion for summary judgment.
2. The effective date of Petitioner’s Medicare participation is May 26, 2009.

For purposes of summary judgment, I accept the material facts of the case set forth by
Petitioner. Petitioner asserts that from September 18, 2008 until May 26, 2009, when the
survey was performed, Petitioner was prepared for the survey, eligible for participation in
Medicare, and in compliance with all federal law. I accept Petitioner’s assertion that
employees of the state agency and of Pinnacle Business Solutions, Inc., the Medicare
carrier (carrier), either informed Petitioner that a survey would be forthcoming shortly
after Petitioner submitted its Medicare enrollment application, or did not inform
Petitioner that there was a moratorium on surveys or some other directive that would
delay Petitioner’s Medicare survey and enrollment. I accept that Petitioner was reassured
by CMS or the carrier that it would be able to bill for services possibly as early as July
10, 2008, not later than August 15, 2008, and certainly not later than September 18, 2008.
l accept that Petitioner expended money to lease its truck and equipment, obtain
insurance, and contract for staffing and billing services. I accept Petitioner’s assertion
that it has sustained approximately $100,000 in lost reimbursements as a result of having
the survey performed on May 26, 2009, instead of on an earlier date, and that Petitioner
worked assiduously to have the survey performed, and that Petitioner acted in good faith
during the entire enrollment process. P. Br. at 1-4; P. Ex. 1. Because I accept the
material facts asserted by Petitioner as the material facts of this case, and because I have
considered the facts in the light most favorable to Petitioner and have drawn all
reasonable inferences in favor of Petitioner, I find there is no need for the in-person
hearing requested by Petitioner to demonstrate its assertion that it provided mobile x-ray
services in good faith and should be reimbursed for them, or to demonstrate the
extraordinary financial hardship that CMS and the state agency caused by failing to act
reasonably and timely consistent with their obligations. P. Br. at 7, 9.

With regard to the legal issues involved, Petitioner argues that the only consistent
enrollment requirement under 42 C.F.R. § 489.13 is that an applicant meet all federal
requirements before billing privileges are extended. Petitioner contends that the
extension of billing privileges is not dependent upon the survey, but upon the date that
the applicant meets all federal requirements. While Petitioner acknowledges that
approval may be effective on the date of the survey if all federal requirements are met on
that date, it asserts the approval only relates to when billing privileges are extended and
not to when services may be provided by the applicant that may be reimbursed by
Medicare. P. Br. at 5-6. Petitioner references the Board’s decision in Renal
CarePartners of Delray Beach, LLC, DAB No 2271 (2009) for the proposition that it
should be permitted to bill and be reimbursed for services prior to the effective date of its
approval as long as it can demonstrate that all the services were provided in accordance
with the applicable federal regulations. P. Br. at 7-8. Petitioner misconstrues the Board’s
decision. In its decision, while the Board found that the enrollment regulations do not
treat CMS or contractor approval as an enrollment requirement that every provider or
supplier must meet to provide reimbursable items or services, it specifically noted that
enrollment regulations specify that the “effective date of reimbursement” is to be
determined by regulations that apply according to the type of provider or supplier
applying to enroll. Renal CarePartners of Delray Beach, LLC, DAB No. 2271, at 6.
Here the language of the regulation at 42 C.F.R. § 489.13(b) is clear and plain and
specifically requires that for a portable x-ray services provider the survey is the condition
precedent to an effective date, and the earliest date that a supplier such as Petitioner can
be approved (assuming that on the date of the survey it met all applicable federal
requirements).

Petitioner also asserts that CMS and the state agency have an obligation to act timely in
working through the application process. Failing to recognize their obligation to timely
conduct a survey after an application is submitted creates an “unconscionable situation in
which the applicant is required to incur prohibitive and substantial costs . . . to be
prepared for the survey that will be scheduled on some date that no one can determine.
The regulations cannot be so rigidly applied that they remove fairness and reasonableness
from the application process, especially when CMS and the state survey agency do not
timely inform an applicant that the state survey agency is prohibited or restricted from
performing any surveys for new suppliers who seek to participate in Medicare.” P. Br. at
6-7. Petitioner asserts CMS’s directive permitted the state agency to continue licensing
even if it could not perform the surveys timely. P. Br. at 7.

Petitioner’s arguments regarding what it terms unreasonable delay in scheduling the
survey, and its arguments regarding its reliance on the state agency or carrier
representations that led it to believe it would be reimbursed for services prior to the
survey date, are equitable arguments. However worthy those arguments may be, I have
no authority under equitable principles to establish an effective date earlier than that
contemplated by 42 C.F.R. § 489.13(b). Oklahoma Heart Hospital, DAB No. 2183
(2008); Forest Glen Skilled Nursing Center, DAB No. 1887 (2003).

IV. Conclusion

For the reasons set forth above, I grant CMS’s motion for summary judgment and affirm
CMS’s determination to approve Petitioner’s Medicare participation effective May 26,
2009, the date the state agency survey found Petitioner to be in compliance with all
applicable federal requirements.

/s/
Richard J. Smith
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Jason Wardell, PA,
Petitioner,
Vv.
Centers for Medicare & Medicaid Services.
Docket No. C-09-772
Decision No. CR2095

Date: March 19, 2010

DECISION

I deny the motion of the Centers for Medicare & Medicaid Services (CMS) to dismiss the
hearing request of Petitioner, Jason Wardell, P.A. On the merits I grant summary
disposition in favor of CMS, deciding that CMS’s contractor, Pinnacle Business
Solutions, Inc. (Pinnacle), and CMS correctly determined that the effective date of
Petitioner’s participation in the Medicare program is March 24, 2009.

I. Background

Petitioner is a physician’s assistant. He filed a hearing request to challenge the
determination that the effective date of his enrollment in Medicare was March 24, 2009.
Petitioner contends that he should be reimbursed for Medicare claims for Medicare
covered items or services that he provided dating back to December 15, 2008.

CMS filed a pre-hearing exchange consisting of a brief, three proposed exhibits (CMS
Ex. 1 — CMS Ex. 3), and a motion to dismiss. Petitioner filed a pre-hearing exchange
consisting of a brief, a proposed exhibit (I identify the exhibit and its attachments as P.
Ex. 1) and his opposition to CMS’s motion to dismiss. I receive all of the parties’
proposed exhibits into the record.
IL. Issues, findings of fact and conclusions of law
A. Issues
The issues in this case are whether:
1. Petitioner is entitled to a hearing on the merits; and

2. Pinnacle and CMS correctly determined the effective date of
Petitioner’s participation in Medicare to be March 24, 2009.

B. Findings of fact and conclusions of law
I make the following findings of fact and conclusions of law.
1. Petitioner is entitled to a hearing on the merits.

CMS’s motion to dismiss is identical to motions that it has filed in many of these cases
involving the issue of effective date of a provider’s participation in Medicare. The
gravamen of CMS’s motion is that the regulations that govern a provider’s enrollment in
Medicare at 42 C.F.R. Part 424 do not allow a provider a hearing to challenge his or her
effective date of enrollment. According to CMS, these regulations allow only a challenge
to a denial of enrollment or a revocation of enrollment and not to a determination as to
effective date of enrollment.

I have addressed this issue on numerous occasions and, on each of them, have denied
CMS’s motion to dismiss. The problem with CMS’s argument is that there is a
regulation, 42 C.F.R. § 498.3(b)(15), which plainly gives a provider a right to a hearing
to challenge the effective date of his or her enrollment. The regulation states that initial
determinations that confer hearing rights include:

The effective date of a Medicare provider agreement or supplier approval.

CMS would have me ignore the plain meaning of the regulation. It contends that this
regulation predates the Part 424 regulations and was intended to confer hearing rights
only in situations not covered under Part 424. That argument is unpersuasive. The
regulation is plain and unambiguous.

Having said that, however, it is important to comprehend exactly what may be
challenged. The sole substantive issue that I may hear and decide in this case is whether
Pinnacle and CMS properly determined Petitioner’s effective date of Medicare to be
March 24, 2009. Petitioner has raised an additional issue which I do not have authority to
hear and decide because it is not a challenge to the effective date of his enrollment.
It is undisputed that Petitioner is a practitioner who was inactive in the Medicare program
for a time due to his military commitment and to his assignment to Iraq. When Petitioner
returned to civilian life he was apparently advised that his provider enrollment had
expired due to inactivity and that he would have to submit a new enrollment application.
It is the effective date that was assigned as a consequence of the new application that is at
issue here.

Not at issue before me is whether Petitioner was entitled to reimbursement pursuant to a
previous enrollment. Petitioner now contends that he was advised that he, in fact, had an
active enrollment that was effective through March 21, 2009 and that claims he submitted
should have been reimbursed on the authority of that previous enrollment. He asserts that
denials of those claims are improper.

I simply lack jurisdiction to hear that issue. That issue is not an effective date of
enrollment issue nor is it an issue having to do with denial or revocation of enrollment.
There is no authority in governing regulations that allows me to decide the question of
whether claims should be reimbursed pursuant to an extant enrollment. That is a
reimbursement issue. Petitioner may have hearing rights on that reimbursement issue but
not before me. Consequently, I dismiss Petitioner’s hearing request insofar as it applies
to his assertions that claims that he filed under a previous enrollment were improperly
denied.

2. Pinnacle and CMS correctly determined Petitioner’s effective date of
enrollment to be March 24, 2009.

The facts of this case are undisputed. On January 26, 2009, Petitioner filed a Medicare
enrollment application with Pinnacle. CMS Ex. 1. On February 7, 2009, Pinnacle
returned the application to Petitioner. It advised Petitioner that his application had been
submitted prematurely. /d. at 2. The problem identified by Pinnacle is that it received
the application more than 30 days prior to the effective date of participation listed on the
application. Jd. The application listed April 1, 2009 as the effective date of Petitioner’s
enrollment. /d. at 23.

Petitioner re-filed his application on April 21, 2009 and Pinnacle received it on April 24,
2009. CMS Ex. 2, at 4. On June 12, 2009, Pinnacle notified Petitioner that his
enrollment application had been approved, with a Provider Transaction Access Number
(PTAN) effective date of March 24, 2009. Jd. at 2. This meant that claims generated by
Petitioner beginning but not prior to March 24, 2009 would be reimbursed pursuant to
Petitioner’s PTAN.

These undisputed facts plainly establish that Pinnacle correctly established an effective
date of enrollment for Petitioner of March 24, 2009. As a matter of law, Pinnacle could
not permit Petitioner to claim reimbursement for items or services that he provided earlier
than that date.

Regulations provide that the effective date of enrollment of a physician or practitioner
such as Petitioner shall be the later of the following:

the date of filing of a Medicare enrollment application that was
subsequently approved by a Medicare contractor or the date an enrolled
physician or nonphysician practitioner first began furnishing services at a
new practice location.

42 C.F.R. § 424.520(d). Additionally, a provider may not claim reimbursement for items
or services that were provided more than 30 days from the effective date of his or her
enrollment. 42 C.F.R. § 424.521(a)(1).

Petitioner filed an application for enrollment on April 24, 2009 that was subsequently
approved by Pinnacle effective that date. By operation of 42 C.F.R. § 424.520(d), April
24, 2009 was the earliest date on which the enrollment application could be approved.
And, by operation of 42 C.F.R. § 424.521(a)(1), claims for items or services provided by
Petitioner could only be reimbursed for those items or services provided by him on
March 24, 2009 or thereafter. Pinnacle thus correctly gave Petitioner an “effective date”
of enrollment of March 24, 2009.!

Petitioner disputes none of the above-described facts. Nor does he assert that CMS’s
interpretation and application of 42 C.F.R. §§ 424.520(d) and 424.521(a)(1) to the facts
are incorrect. Essentially, Petitioner makes an equitable argument, asserting that he
applied for enrollment only after months of evidently frustrating discussions with
(apparently) Pinnacle about his enrollment status. In effect, Petitioner asserts that a
bureaucratic snafu may have delayed his ultimate enrollment and caused him to receive
an effective date that was later than he might otherwise have obtained.

' Technically, there is an error in Pinnacle’s approval of Petitioner’s application for
enrollment but it is harmless and has no effect on the outcome of this case. By
regulation, the “effective date” of Petitioner’s enrollment is April 24, 2009, the date that
he filed the application that Pinnacle subsequently approved. The earliest reimbursement
date for items or services generated by Petitioner is March 24, 2009. In approving
Petitioner’s application, Pinnacle erroneously referred to March 24 as the “effective date”
of his enrollment when it should have said that the effective date was April 24 and the
earliest reimbursement date was March 24. However, this error is harmless because
Pinnacle and CMS have made it clear that Petitioner is ineligible for reimbursement for
claims that were generated prior to March 24.

I do not address the merits of these assertions because they are irrelevant. The effective
date of a provider’s Medicare enrollment is governed by regulations that brook no
exceptions and the undisputed facts of this case show that these regulations were applied
correctly here.”

Petitioner also argues that his claims should be reimbursed under a different PTAN than
the one he received from Pinnacle that is the subject of this case. As I discuss at Finding
1, I have no authority to hear that issue.

/s/
Steven T. Kessel
Administrative Law Judge

>T note, however, that Petitioner has provided no explanation for his waiting more than
two months after Pinnacle returned his first application before filing a second one.
Presumably, had Petitioner re-filed sooner, he would have received an effective
enrollment date that is earlier than March 24, 2009.