Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division
Plott Nursing Home
(CCN: 05-5619),
Petitioner
Vv.
Centers for Medicare and Medicaid Services.
Docket Nos. C-09-189, C-09-357
Decision No. CR2326

Date: February 17, 2011

DECISION

Petitioner, Plott Nursing Home, was not in substantial compliance with program
participation requirements from September 24, 2008 through December 15, 2008, due to
violations of 42 C.F.R. §§ 483.25(c)' (Tag F314) and 483.25(d)(2) (Tag F315). There is
a basis for the imposition of enforcement remedies. The following enforcement remedies
are reasonable: a civil money penalty (CMP) of $500 per day from September 24
through December 3, 2008 and $100 per day from December 4 through 15, 2008, a total
CMP of $36,700; and a denial of payments for new admissions (DPNA) from November
22, 2008 through December 15, 2008.

' Citations are to the version of the Code of Federal Regulations (C.F.R.) in effect at the
time of the surveys, unless otherwise indicated.
I. Background

Petitioner is located in Ontario, California, and participates in Medicare as a skilled
nursing facility (SNF) and the state Medicaid program as a nursing facility (NF). On
September 24, 2008, the California Department of Public Health (state agency) surveyed
Petitioner and concluded that Petitioner was not in substantial compliance with program
participation requirements. The Centers for Medicare and Medicaid Services (CMS)
notified Petitioner by letter dated November 7, 2008, that it was imposing the following
enforcement remedies: a $500 per day CMP effective September 24, 2008 and a DPNA
effective November 22, 2008. The state agency completed a revisit survey on December
4, 2008, but Petitioner was not found to have returned to substantial compliance. CMS
notified Petitioner by letter dated February 10, 2009, that Petitioner returned to
substantial compliance with participation requirements on December 16, 2008 and that
the CMP was reduced to $100 per day for the period December 4 through December 15,
2008. Joint Stipulation of Undisputed Facts.

Petitioner requested a hearing before an administrative law judge (ALJ) by letters dated
January 2, 2009 and March 24, 2009, which were docketed as C-09-189 and C-09-357,
respectively. The cases were assigned to me for hearing and decision. On April 13,
2009, I ordered that the cases be consolidated. On December 7 through 10, 2009, a
earing was convened in San Bernardino, California and a 1058-page transcript (Tr.) of
the proceedings was prepared. CMS offered CMS exhibits (CMS Exs.) 1 through 64 and
66 through 73 that were admitted as evidence. Tr. at 31-32, 581-82. Petitioner offered
Petitioner exhibits (P. Exs.) 1 through 53, and P. Exs. | through 40, page 3 of 41, and 42
through 53 were admitted as evidence. Tr. at 36-55, 819. CMS called the following
witnesses: Lieutenant Commander (LCDR) Kelly Valente, Pharm.D., US Public Health
Service; Surveyor Michelle Renee Buell, RN; Surveyor Charmaine DeBay, RN; Surveyor
Eleanor Pruitt, RN; Surveyor Linda Walton, RN; Surveyor Janine Nichols, RN; Surveyor
Deanna Wali, RN; and Surveyor Napoleon Imperio, RN. Petitioner called the following
witnesses: Anthony Scarpelli, Petitioner’s Administrator; Rasmy Nambela, RN,
Petitioner’s Director of Nursing (DON); Wendy Perez, LVN, Petitioner’s Director of
Staff Development; Carol Wagner, RN; John Randolph, MD; Thomas Woodbury, DO,
Petitioner’s Medical Director; Elizabeth Sterling, Pharm.D., Petitioner’s consultant
pharmacist; and William Simonson, Pharm.D., FASCP. The parties filed post-hearing
briefs (CMS Br. and P. Br., respectively) and post-hearing reply briefs (CMS Reply and
P. Reply, respectively).

II. Discussion

A. Issues

The issues in this case are:
Whether there is a basis for the imposition of an enforcement

remedy; and

Whether the remedies proposed are reasonable.

B. Applicable L

The statutory and regula’
are found at sections 18

aw

tory requirements for participation by a long-term care facility
9 (SNF) and 1919 (NF) of the Act and at 42 C.F.R. Part 483.

Section 1819(h)(2) of the Act vests the Secretary of Health and Human Services
(Secretary) with authority to impose enforcement remedies against a SNF for failure to
comply substantially with the federal participation requirements established by sections

1819(b), (c), and (d) of t
Medicare payments to a
found not in compliance
SNF does not return to c
the Secretary must deny

e Act.” Pursuant to 1819(h)(2)(C), the Secretary may continue
SNF not longer than six months after the date the facility is first
with participation requirements. Pursuant to 1819(h)(2)(D), ifa
compliance with participation requirements within three months,

payments for all individuals admitted to the facility after that

date — commonly referred to as the mandatory or statutory DPNA. In addition to the
authority to terminate a noncompliant SNF’s participation in Medicare, the Act grants the
Secretary authority to impose other enforcement remedies, including a discretionary
DPNA, CMPs, appointment of temporary management, and other remedies such as a
directed plan of correction. Act § 1819(h)(2)(B).

The Secretary has delegated to CMS and the states the authority to impose remedies

against a long-term care
participation requirement
the requirements of parti
to resident health or safe

‘acility that is not complying substantially with federal

its. “Substantial compliance means a level of compliance with
cipation such that any identified deficiencies pose no greater risk
‘ty than the potential for causing minimal harm.” 42 C.F.R.

§ 488.301 (emphasis in original). A deficiency is a violation of a participation
requirement established by sections 1819(b), (c), and (d) of the Act or the Secretary’s
regulations at 42 C.F.R. Part 483, subpart B. State survey agencies survey facilities that
participate in Medicare on behalf of CMS to determine whether the facilities are
complying with federal participation requirements. 42 C.F.R. §§ 488.10-.28, 488.300-

.335. The regulations sp
facility is not in substant:
§ 488.406.

ecify the enforcement remedies that CMS may impose if a
ial compliance with Medicare requirements. 42 C.F.R.

> Section 1919(h)(2) of the Act gives similar enforcement authority to the states to
ensure that NFs comply with their participation requirements established by sections
1919(b), (c), and (d) of the Act.
The regulations specify that a CMP that is imposed against a facility on a per day basis
will fall into one of two ranges of penalties. 42 C.F.R. §§ 488.408, 488.438. The upper
range of a CMP, $3,050 per day to $10,000 per day, is reserved for deficiencies that pose
immediate jeopardy to a facility’s residents and, in some circumstances, for repeated
deficiencies. 42 C.F.R. § 488.438(a)(1)(i), (d)(2). “Immediate jeopardy means a
situation in which the provider’s noncompliance with one or more requirements of
participation has caused, or is likely to cause, serious injury, harm, impairment, or death
to a resident.” 42 C.F.R. § 488.301 (emphasis in original). The lower range of a CMP,
$50 per day to $3,000 per day, is reserved for deficiencies that do not constitute
immediate jeopardy but either cause actual harm to residents, or cause no actual harm but
have the potential for causing more than minimal harm. 42 C.F.R. § 488.438(a)(1)(ii).

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

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

§§ 488.408(g)(1), 488.330(e), 498.3. However, the choice of remedies or the factors
CMS considered when choosing remedies are not subject to review. 42 C.F.R.

§ 488.408(g)(2). A facility may only challenge the scope and severity level of
noncompliance CMS determined if a successful challenge would affect the range of the
CMP that may be imposed or impact the facility’s authority to conduct a nurse aide
training and competency evaluation program. 42 C.F.R. § 498.3(b)(14), (d)(10)(i). The
CMS determination as to the level of noncompliance, including the finding of immediate
jeopardy, “must be upheld unless it is clearly erroneous.” 42 C.F.R. § 498.60(c)(2).
Woodstock Care Ctr., DAB No. 1726 at 9, 38 (2000), aff'd, 363 F.3d 583 (6th Cir. 2003).
The Departmental Appeals Board (the Board) has long held that the net effect of the
regulations is that a provider has no right to challenge the scope and severity level
assigned to a noncompliance finding, except in the situation where that finding was the
basis for an immediate jeopardy determination. See, e.g., Ridge Terrace, DAB No. 1834
(2002); Koester Pavilion, DAB No. 1750 (2000). Review of a CMP is subject to 42
CFR. § 488.438(e).

The standard of proof or quantum of evidence required is a preponderance of the
evidence. CMS has the burden of coming forward with the evidence and making a prima
facie showing of a basis for imposition of an enforcement remedy. Petitioner bears the
burden of persuasion to show by a preponderance of the evidence that it was in
substantial compliance with participation requirements or any affirmative defense.
Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing
& Convalescent Ctr., DAB No. 1904 (2004), aff'd, Batavia Nursing & Convalescent Ctr.
v. Thompson, 129 F. App’x 181 (6th Cir. 2005); Emerald Oaks, DAB No. 1800; Cross
Creek Health Care Ctr., DAB No. 1665 (1998); see Hillman Rehab. Ctr., DAB No. 1611
(1997), No. 98-3789, 1999 WL 34813783 (D.N.J. May 13, 1999).

C. Findings of Fact, Conclusions of Law, and Analysis

My conclusions of law are set forth in bold text followed by my findings of fact and
analysis. Based upon the surveys that ended September 24, 2008 and December 4, 2008,
CMS alleges that Petitioner was not in substantial compliance with program participation
requirements from September 24, 2008 through December 15, 2008, based upon the
following regulatory violations: 42 C.F.R. §§ 483.10(b)(11) (Tag F157,° scope and
severity (s/s) * D); 483.13(a) (Tag F 221, s/s D); 483.15(g)(1) (Tag F250, s/s D);
483.15(h)(2) (F253, s/s E); 483.20(g)-(j) (Tag F278, s/s D); 483.20(d), (k)(1) (Tag F279,

> This is a “Tag” designation as used in CMS Publication 100-07, State Operations
Manual (SOM), Appendix PP — Guidance to Surveyors for Long Term Care Facilities
(http://www.cms.hhs.gov/Manuals/IOM/list.asp). The “Tag” refers to the specific
regulatory provision allegedly violated and CMS’s related guidance to surveyors.
Although the SOM does not have the force and effect of law, the provisions of the Act
and regulations interpreted clearly do have such force and effect. Northwest Tissue Ctr.
v. Shalala, 1 F.3d 522 (7th Cir. 1993); State of Ind. by Ind. Dep’t of Pub. Welfare v.
Sullivan, 934 F.2d 853 (7th Cir. 1991). Thus, while the Secretary may not seek to
enforce the provisions of the SOM, she may seek to enforce the provisions of the Act or
regulations as interpreted by the SOM.

* CMS and the state agency use scope and severity levels when selecting remedies. The
scope and severity level is designated by an alpha character, A through L, that CMS or
the state agency selects from the scope and severity matrix published in the SOM, Chap.
7, § TA00E. A scope and severity level of A, B, or C indicates a deficiency that presents
no actual harm but has the potential for minimal harm, which is an insufficient basis for
imposing an enforcement remedy. Facilities with deficiencies of a level no greater than
C remain in substantial compliance. 42 C.F.R. § 488.301. A scope and severity level of
D, E, or F indicates a deficiency that presents no actual harm but has the potential for
more than minimal harm that does not amount to immediate jeopardy. A scope and
severity level of G, H, or I indicates a deficiency that involves actual harm that does not
amount to immediate jeopardy. Scope and severity levels J, K, and L are deficiencies
that constitute immediate jeopardy to resident health or safety. The matrix, which is
based on 42 C.F.R. § 488.408, specifies the remedies that are required and optional at
each level based upon the frequency of the deficiency.
s/s E); 483.25 (F309, s/s D); 483.25(a)(1) (F311, s/s D); 483.25(c) (Tag F314, s/s D);
483.25(d) (Tag F315, s/s H); 483.25(e)(2) (F318, s/s D); 483.25(h) (Tag F323, s/s D);
483.25(i) (Tag F325, s/s D); 483.25(1) (F329, s/s G); 483.35(d)(3) (Tag F365, s/s D);
483.35(e) (Tag F367, s/s D); 483.35(i) (Tag F371, s/s D); 483.40(c)(3)-(4) (Tag F388, s/s
D); 483.60(c) (Tag F428, s/s D); 483.60(b), (d), (e) (Tag F431, s/s E); 483.65(a) (Tag
F441, s/s F); 483.70(f) (Tag F463, s/s D); 483.70(h) (Tag F465, s/s E); 483.75(f) (Tag
F498, s/s F); 483.75(i) (Tag F501, s/s F); 483.75(j)(3)(ii) (Tag F505, s/s D); and
483.75(0)(1) (Tag F520, s/s F).° The December 4, 2008 survey cited only a violation of
42 C.F.R. § 483.25(d) (Tag F315) as posing a risk for more than minimal harm and only
that deficiency citation may be the basis for an enforcement remedy (42 C.F.R. §§
488.301, 488.402(b), 498.3(b)(13)) and is subject to my review (42 C.F.R. § 488.408(g)).

I conclude that Petitioner violated 42 C.F.R. § 483.25(c) (Tag F314) and that the
violation resulted in actual harm to Petitioner’s residents, as alleged by the September 24,
2008 survey. I also conclude that Petitioner violated 42 C.F.R. § 483.25(d) (F315) as
alleged by the surveys completed September 24 and December 4, 2008. The deficiencies
under Tags F314 and F315 establish that Petitioner was not in substantial compliance
during the period September 24 through December 15, 2008. The deficiencies also
provide a sufficient basis for the enforcement remedies that CMS proposes. Thus, I
conclude it is not necessary to address all the other alleged deficiencies from the
September 2008 survey. The enforcement remedies proposed by CMS are reasonable.

I have carefully considered all the evidence, including the documents and the testimony
at hearing, and the arguments of both parties, though not all may be specifically discussed
in this decision. I discuss in this decision the credible evidence given the greatest weight
in my decision-making.° The fact that evidence is not specifically discussed should not
be considered sufficient to rebut the presumption that I considered all the evidence and
assigned such weight or probative value to the credible evidence that I determined
appropriate within my discretion as an ALJ. There is no requirement for me to discuss
the weight given every piece of evidence considered in this case, nor would it be
consistent with notions of judicial economy to do so.

> The parties stipulated at hearing that CMS was not proceeding upon certain
deficiencies cited by the September 24, 2008 survey. Tr. at 647-50.

® “Credible evidence’ is evidence that is worthy of belief. Blacks Law Dictionary 596
(18" ed. 2004). The “weight of evidence” is the persuasiveness of some evidence
compared to other evidence. Jd. at 1625.
1. Petitioner violated 42 C.F.R. § 483.25(c) (Tag F314), as determined
by the survey completed on September 24, 2008, and that violation
caused actual harm.

The quality of care regulation includes the requirement that a facility ensure that a
resident who enters the facility without a pressure sore does not develop one unless
clinically unavoidable. The regulations also require that a resident entering with a
pressure sore receives care and services necessary to: promote healing; prevent infection;
and prevent other sores from developing. 42 C.F.R. § 483.25(c).

The application of the regulation has been extensively discussed in decisions of various
appellate panels of the Board, including Koester Pavilion, DAB No. 1750 and Cross
Creek Health Care Ctr., DAB No. 1665. The Board has recognized that the pressure sore
regulation has two prongs: (1) a facility must ensure a resident who enters the facility
without sores does not develop sores unless the resident’s clinical condition demonstrates
that pressure sores are unavoidable; and (2) a resident with pressure sores must receive
necessary treatment and services to promote healing, prevent infection and prevent new
sores. Regarding prevention and treatment, the Board has concluded that a facility bears
a duty to “go beyond merely what seems reasonable to, instead, always furnish what is
necessary to prevent new sores, unless clinically unavoidable, and to treat existing ones
as needed.” See Koester Pavilion, DAB No. 1750, at 32; see also Meadow Wood
Nursing Home, DAB No. 1841 (2002) (loose dressing contaminated with fecal matter
constitutes violation); Ridge Terrace, DAB No. 1834, at 15-16 (a single observation by a
surveyor of a nurse aide cleaning an open sore area with a stool-stained washcloth was
sufficient to sustain a deficiency finding under this Tag). If CMS establishes a prima
facie case, the facility bears the burden of showing that the development or deterioration
of a pressure sore was clinically unavoidable.

An appellate panel of the Board in Clermont Nursing & Convalescent Ctr., DAB No.
1923, at 9-10 (2004), aff'd, Clermont Nursing & Convalescent Ctr. v. Leavitt, 142 F.
App’x 900 (6th Cir. 2005), provided the following analysis:

The standard of necessity is expressly articulated in the
regulation. The primary regulatory requirement is that
residents must receive, and facilities must provide, “the
necessary care and services” for attainment or maintenance of
the highest practicable resident well-being. 42 C.F.R.

§ 483.25 (emphasis supplied). The regulation then goes on to
provide that a resident with pressure sores must receive
“necessary treatment and services” for healing, prevention of
infection, and prevention of yet more pressure sores. 42
C.F.R. § 483.25(c)(2) (emphasis supplied). We therefore
reject Clermont’s contention that the standard is “nowhere in

the regulation.” That argument is belied by the plain
language of the regulation.

Moreover, as we explained in Koester Pavilion, in the
preamble to the final regulation, CMS expressly declined to
use “less demanding” language with respect to a facility’s
obligation to “ensure” outcome of treatment for pressure
sores. Koester Pavilion at 30, quoting 56 Fed. Reg. 48,826, at
48,850 (Sept. 26, 1991). CMS recognized that factors beyond
required treatment and services, such as disease process and
resident compliance, affect care outcome. Jd. However,
CMS also recognized that the regulation allows a facility to
put forward “available clinical evidence” to show that “a
negative resident care outcome was unavoidable.” Jd. The
preamble further provides that facilities “should always
furnish the necessary treatment and services” for pressure
sore prevention or healing. Jd. at 30-31(emphasis supplied).
Thus, a facility may provide necessary treatment and services
to ensure the prevention or healing of pressure sores, yet still
be confronted with a negative outcome. In that instance, the
facility may put forward clinical evidence to show that the
outcome was unavoidable.

See also Woodland Vill. Nursing Ctr., DAB No. 2172, at 12-14 (2008).
The SOM defines avoidable and unavoidable pressure ulcers as:
“Avoidable/Unavoidable” Pressure Ulcers

o “Avoidable” means that the resident developed a pressure
ulcer and that the facility did not do one or more of the
following: evaluate the resident’s clinical condition and
pressure ulcer risk factors; define and implement
interventions that are consistent with resident needs, resident
goals, and recognized standards of practice; monitor and
evaluate the impact of the interventions; or revise the
interventions as appropriate.

o “Unavoidable” means that the resident developed a pressure
ulcer even though the facility had evaluated the resident’s
clinical condition and pressure ulcer risk factors; defined and
implemented interventions that are consistent with resident
needs, goals, and recognized standards of practice; monitored
and evaluated the impact of the interventions; and revised the
approaches as appropriate.

SOM, app. PP, Tag F314.

The surveyors allege in the Statement of Deficiencies (SOD) for the September 24, 2008
survey that Petitioner violated 42 C.F.R. § 483.25(c) (Tag F314) because Petitioner failed
to provide necessary treatment and services to prevent healed pressure sores from
reopening and to prevent the development of new sores in the case of Resident 6. CMS
Ex. 1, at 49.

a. Facts

Resident 6 had a care plan for skin breakdown dated June 2007, with the following
interventions: check skin daily during care; turn and reposition every two hours; provide
good perineal care with each episode of incontinence; keep skin clean and dry as
possible; the resident should be up in her geriatric chair each day; and the resident was to
have a pressure relief mattress. The care plan was updated on November 21, 2007,
without additional interventions being added. P. Ex. 11, at 256. A continuation sheet for
the care plan for skin breakdown indicates that Resident 6 slid down in her bed, was non-
compliant with turning and repositioning, and refused to be turned. The interventions
added on March 18, 2008, were to assist the resident with positioning in bed, monitor her
for turning and repositioning, and assess her skin during activities of daily living. P. Ex.
11, at 258.

Wound Care Evaluation Records from December 26, 2007 through February 29, 2008,
show that Resident 6 developed an ulcer over her sacrum’ that was closed as of February
29. P. Ex. 11, at 283-85, 298, 307-08. A Wound Care Evaluation Record dated March
13, 2008, shows that a coccyx wound had reopened and that it closed by March 20, 2008.
P. Ex. 11, at 309. Wound Care Evaluation Records from May 23, 2008 through May 30,
2008, show that Resident 6 had an open ulcer on her coccyx. P. Ex. 11, at 301-302.

A physician’s order dated June 5, 2008, states that Resident 6, who was 81 years old, was
readmitted to Petitioner’s facility with diagnoses of MRSA in her scalp wound; left ankle
sprain, aphasia, cognitive disorder secondary to a craniotomy, hypertension, and

7 Petitioner’s records refer to ulcers over both the sacrum and the coccyx. Because the
sacrum and coccyx are adjacent, I recognize the possibility that the terms are being used
interchangeably. Whether Resident 6 had an ulcer over the coccyx or the sacrum or both
does not affect my decision.
10

allergies. P. Ex. 11, at 222-25. An admission Minimum Data Set (MDS) for Resident 6
with an assessment reference date of June 18, 2008, shows she was readmitted to
Petitioner’s facility on June 5, 2008 from an acute care hospital. The MDS shows she
was previously a resident of Petitioner’s facility. Her diagnoses listed included
hypertension, arthritis, osteoporosis, Alzheimer’s disease, dementia other than due to
Alzheimer’s, depression and anxiety, anemia, cancer, antibiotic resistant infection,
septicemia, a history of urinary tract infection in the last 30 days, a history of a malignant
neoplasm of the brain, dysphagia, malnutrition, gastrointestinal distress, and expressive
aphasia. She was assessed as severely impaired for daily decision-making; she rarely
understood others but could sometimes be understood; she was totally dependent upon
staff for activities of daily living including bed mobility; she was incontinent of bowel
and bladder; she had one Stage 2 pressure ulcer; she was noted to have a pressure
relieving device for both bed and chair, to be on a turning/repositioning program, to have
nutrition or hydration interventions, to be receiving ulcer care and surgical wound care, to
receive the application of dressings and ointments and medication, and other preventive
or protective skin care. P. Ex. 11, at 269-75.

Wound Care Evaluation Records from June 5 to June 18, 2008, show that Resident 6 had
a pressure ulcer over her coccyx that resolved. P. Ex. 11, at 288-89. Wound Care
Evaluation Records show that Resident 6 developed a pressure ulcer over her coccyx on
June 26, 2008 that resolved by August 21, 2008. P. Ex. 11, at 290-93, 297. A Wound
Care Assessment dated July 31, 2008, reflects a healing lower sacrum pressure ulcer, 0.5
by 0.3 centimeters, with no measurable depth, with a scab, and no exudate. Orders were
to discontinue hydrocolloid dressing, apply skin prep to wound and surrounding tissue,
keep wound open to air, reposition per facility protocol, and a revisit in one week. P. Ex.
11, at 230-31. A Wound Care Assessment dated August 7, 2008, indicates that the lower
sacrum pressure ulcer measured 1.0 by 0.3 centimeters with a scab and no exudate, the
wound was improving and the increased size reflected the inclusion in the measurement
of healing skin that was around the wound. Orders were to clean the wound daily with
normal saline, apply skin preparation to the wound and surrounding skin, repositioning
per facility policy, and continue use of low air loss mattress (the first reference to such
a mattress in the evidence before me). P. Ex. 11, at 234-35. A Wound Care Assessment
dated August 14, 2008, shows a new healing pressure sore, 1.5 by 0.5 centimeters with no
measurable depth, no exudate, with a note that the previous sacral wound had resolved
with only very superficial excoriation remaining. Orders were to continue repositioning
per facility protocol, continue use of low air loss mattress, clean daily with normal
saline, apply skin preparation to sacral area, and leave the sacral area open to air. P. Ex.
11, at 232-33. A wound care assessment dated August 21, 2008, shows that all sacral
wounds were resolved. P. Ex. 11, at 236-37.

Wound Care Evaluation records reflect that on August 27, 2008, the coccyx wound was
reopened. The ulcer was reflected on Wound Care Evaluation records through
September 22, 2008. P. Ex. 11, at 295-96. The presence of this ulcer and the
11

development of the new ulcer on the resident’s left lower buttock triggered the significant
change MDS of September 18, 2008.

Resident 6’s significant change MDS with an assessment reference date of September 18,
2008, shows that she was assessed as severely impaired for daily decision-making; she
rarely understood others but could sometimes be understood; she was totally dependent
upon staff for activities of daily living including bed mobility; and she was incontinent of
bowel and bladder; she had two Stage 2 pressure ulcers; she was noted to have a pressure
relieving device for both bed and chair, to be on a turning/repositioning program, to have
nutrition or hydration interventions, to be receiving ulcer care and surgical wound care, to
receive the application of dressings and ointments and medication, and other preventive
or protective skin care. P. Ex. 11, at 260-64. A “Global RAP Narrative” dated
September 18, 2008, indicates that the significant change MDS was done because
Resident 6 developed an excoriation to the left lower buttock. The Narrative also
indicates that Resident 6 continued to receive treatment for her coccyx wound, with a
weekly wound consult; and that she was at risk for further skin breakdown due to her
deficits and diagnoses. The Narrative lists the following interventions: treatment of the
ulcers as ordered, daily monitoring of the skin during activities of daily living, nutritional
supplement, turning and repositioning every two hours, and perineal care after each
episode of incontinence. P. Ex. 11, at 279-80.

Resident 6’s care plan dated June 18, 2008, with updated interventions in June and July
2008, show that she was assessed as at risk for further skin breakdown due to decreased
mobility and self-care deficits, with an open area on her coccyx on admission and MRSA
in her craniotomy wound. The goal was to have no further skin breakdown. The care
planned interventions were to: monitor skin everyday during activities of daily living;
assist with turning and repositioning; provide perineal care with every incontinence
episode; she was to wear mittens to prevent her from picking her head wound; she was to
be given a supplement with every meal; she was to have treatment to the coccyx as
ordered. P. Ex. 11, at 245. A continuation sheet for the care plan contains additional
interventions dated July 23, 2008, related to cleaning the coccyx wound and the use of
Tegasorb dressings to be changed every three days for three weeks. The intervention of
applying a skin preparation wipe to the coccyx as a protective measure was added on July
31, 2008. Use of a low air loss mattress was not added as an intervention until September
24, 2008. Carol Wagner RN, a special project person for Petitioner testified that a
pressure relief mattress was added as an intervention on June 9, 2008, according to a “late
entry” added to the care plan on October 4, 2008. Tr. at 819, 853. P. Ex. 11, at 247.
Another continuation sheet includes an intervention, dated August 5, 2008, to continue
treatment to the coccyx including keeping off pressure and report any changes to the
physician. An intervention dated September 18, 2008, requires turning and repositioning,
perineal care, a supplement with every meal, and treatment to the left buttock. P. Ex. 11,
at 249.
12

b. Analysis

The gist of the CMS case and the basis for the deficiency citation is that Petitioner did not
do all that was necessary for Resident 6 to prevent the development of new pressure
ulcers.* The fact that Resident 6 developed multiple pressure ulcers while under
Petitioner’s care is undisputed.

The evidence shows that Resident 6 had a care plan from June 2007 that required: skin
checks daily during care; turning and repositioning every two hours; cleaning after each
episode of incontinence; maintaining her skin clean and dry; that she be up in her
geriatric chair for some time each day; and that she have a pressure relief mattress. P. Ex.
11, at 256. Despite her care plan, Resident 6 developed an open pressure ulcer on her
sacrum on December 26, 2007 that was reported to be closed on about February 29,
2008.° P. Ex. 11, at 283-85, 298, 307-08. Petitioner has presented no evidence that the
care planning team evaluated the effectiveness of the interventions from the June 2007
care plan or that any new interventions were proposed and implemented based upon the
development of the new ulcer on about December 26, 2007. The development of the new
ulcer should have alerted the care planning team that existing interventions were
inadequate or that new interventions were required. The development of the new ulcer
triggers the inference that Petitioner was not doing all that was necessary.

Either the sacral ulcer reopened or a new ulcer developed over Resident 6’s coccyx on
about March 13, 2008. P. Ex. 11, at 309. The evidence shows that Resident 6’s care plan
was revised on March 18, 2008 to address her sliding down in her bed and
noncompliance with turning and repositioning. The interventions added on March 18,
2008, were to assist the resident with positioning in bed, monitoring her for turning and
repositioning, and assessing her skin during activities of daily living. P. Ex. 11, at 258.
The coccyx or sacral ulcer was reported to have closed as of March 20, 2008. P. Ex. 11,
at 309. Petitioner presented no evidence to explain why issues related to position in the
bed and noncompliance were not addressed by the care planning team prior to the
development of an ulcer on March 13, 2008. The evidence indicates that the resident’s

® CMS refers to the reopening of a pressure ulcer on the coccyx. Based upon my review
of the evidence, it is not possible or necessary to distinguish between the reopening of a
mostly healed pressure ulcer and the development of a new ulcer in proximity to the prior
pressure ulcer.

° Petitioner’s records do not indicate the “stage” for the various ulcers reported.
However, the descriptions in the cited clinical records support an inference that the ulcers
were all Stage 2 as described by the SOM, app. PP, Tag F314.
13

noncompliance and sliding in bed existed prior to the development of the ulcer. Because
the resident was known to be at risk for skin breakdown, Petitioner’s failure to care plan
to address sliding in bed and noncompliance with turning and repositioning triggers the
inference that Petitioner was not doing all that was necessary.

On about May 23, 2008, Resident 6 developed another pressure ulcer over her coccyx. P.
Ex. 11, at 301. The ulcer continued to be reported on May 30, 2008. P. Ex. 11, at 301-
302. The evidence does not show that the care planning team evaluated the effectiveness
of the interventions from the June 2007 care plan as updated through March 18, 2008, or
that any new interventions were proposed and implemented based on the development of
the new ulcer on about May 23, 2008. The development of the new ulcer should have
alerted the care planning team that existing interventions were inadequate or that new
interventions were required. The development of the new ulcer triggers the inference that
Petitioner was not doing all that was necessary.

The evidence shows that Resident 6 went to an acute care hospital sometime between
May 30 and June 5, 2008. On June 5, 2008, she was readmitted to Petitioner’s facility.
On June 5, 2008, she was reported to have an ulcer over her coccyx, whether or not this
was the same ulcer reported on May 30, 2008 is not clear, but I infer it is. Petitioner’s
records show that the ulcer was closed as of June 18, 2008. P. Ex. 11, at 288-89. The
evidence does not show that the care plan was updated prior to June 18, 2008, while the
ulcer was opened. However, a new care plan was developed following completion of the
admission MDS with the reference date of June 18, 2008.

The June 18, 2008 care plan required that Resident 6’s: skin be monitored everyday; that
she be turned and repositioned, but the frequency is not indicated; that she be cleaned
after every episode of incontinence; that she receive a supplement with every meal; and
that she have treatment of her coccyx as ordered. P. Ex. 11, at 245. A pressure relief
mattress was added as an intervention on June 9, 2008, although it was not documented
until October 4, 2008, after the survey. P. Ex. 11, at 247; Tr. at 853. Petitioner argues
that a pressure relief mattress was a standard intervention for residents subject to skin
breakdown. P. Br. at 19. Petitioner does not specify in its brief when Resident 6 was
placed on a pressure relief mattress. However, if Petitioner’s position is that Resident 6
was on a pressure relief mattress prior to June 9, 2008, surely staff who updated the care
plan with the late entry on October 4, 2008, would have indicated a date earlier than June
9, 2008. Nurse Wagner testified only that a pressure relieving mattress was in use at the
time of the survey. Tr. at 819. Petitioner does not present credible evidence as to why
the pressure relief mattress was not actually listed on Resident 6’s care plan until October
2008, after the survey and long after June 2007, the first evidence in the clinical record of
a care plan for skin breakdown. Petitioner also does not explain why a nutritional
supplement was not added as an intervention until June 2008.
14

The evidence shows that on or about July 23 or 24, 2008, Resident 6 developed a new
pressure ulcer over her lower sacrum that was evaluated by the physician on July 31,
2008. P. Ex. 11, at 230-31. Interventions added on July 23, 2008, related to cleaning the
coccyx wound and the use of Tegasorb dressings to be changed every three days for three
weeks. The intervention of applying a skin preparation wipe to the coccyx as a protective
measure was added on July 31, 2008. An intervention was added, dated August 5, 2008,
to continue treatment to the coccyx, including keeping off pressure, and report any
changes to the physician. P. Ex. 11, at 249. Wound assessments were done on August 7
and 14, 2008, and orders included the continued use of a “low air loss mattress.” P. Ex.
11, at 232-35. Resident 6’s care plan at the time did not list either a “low air loss
mattress” or a “pressure relief mattress.” Petitioner presented evidence that it used a
Panacea® Ultimate 3000 mattress for Resident 6, which according to manufacture’s
literature is not an air mattress. P. Ex. 42; Tr. at 819. According to the care plan and the
testimony of Petitioner’s witness, RN Wagner, the low air loss mattress, first ordered
August 7, 2008, was not actually implemented by Petitioner until September 24, 2008.
Tr. at 853; P. Ex. 11, at 247. The wound was reported to be resolved on August 21, 2008.
P. Ex. 11, at 236-37. Resident 6’s new ulcer on her left buttock triggered the addition of
interventions to the care plan on September 18, 2008, including turning and
repositioning, perineal care, a supplement with every meal, and treatment to the left
buttock. P. Ex. 11, at 249. An intervention added to the care plan dated September 24,

2008, specified the use of the low air loss mattress (Tr.

been ordered on August 7, 2008 and again on August
The next entry on the care plan is the October 4, 2008

at 853; P. Ex. 11, at 247) that had
4, 2008. P. Ex. 11, at 232-35.
entry that indicates it is a late entry

and that a pressure relief mattress was to be implemented on June 9, 2008.

I conclude that there is a prima facie showing of a vio

ation of 42 C.F.R. § 483.25(c)

because Petitioner did not do all that was necessary to prevent Resident 6 from
developing new pressure sores. The evidence does not show that the effectiveness of
interventions was assessed or that new interventions were implemented when Resident 6

develop new or reopened ulcers in
Furthermore, the evidence shows tl

December 2007, May 2008, or late June 2008.
at Petitioner failed to implement the low air loss

mattress in August 2008, when it was ordered. I conclude that there is no merit to
Petitioner’s argument that Resident 6’s pressure ulcers were unavoidable. P. Br. at 18-
20; P. Reply at 15-16. The evidence shows that Resident 6 had multiple pressure sores
that healed, which is good evidence that the development of new pressure sores was

avoidable. RN Wagner agreed wit!

counsel for CMS that the fact a resident has ulcers

that heal is an indication the resident has the physiological resources necessary to heal
and, thus, prevent ulcers. Tr. at 853-54. Furthermore, Petitioner added new interventions

over time that led to the resolution
interventions that are properly imp:

of each ulcer, which shows that the addition of proper
lement, would be effective for the healing and

prevention of ulcers. RN Wagner characterized the interventions implemented by
Petitioner to address skin breakdowns to be “aggressive interventions.” Tr. at 822.

However, RN Wagner did not simi:

arly characterize Petitioner’s interventions to prevent
15

the development of new ulcers or the reopening of old ulcers. Petitioner offers no
explanation for why the evidence does not show it implemented the pressure relief
mattress, nutritional supplement, and other interventions that ultimately proved effective,
when Resident 6 was first assessed as at risk for pressure ulcers in June 2007.

Petitioner argues that Resident 6 was not a risk for any harm due to Petitioner’s treatment
of her. To the contrary, Resident 6 developed open sores on her coccyx or sacrum which
I conclude is actual harm with or without specific indication that the resident suffered
pain or discomfort to any particular degree.'°

Accordingly, I conclude that Petitioner violated 42 C.F.R. § 483.25(c) based upon the
example of Resident 6, and that the resident suffered actual harm as a result.

2. Petitioner violated 42 C.F.R. § 483.25(d)(2) (Tag F315) as alleged by
the survey completed on September 24, 2008, and that violation
resulted in actual harm.

3. Petitioner violated 42 C.F.R. § 483.25(d)(2) (Tag F315) as alleged by
the survey completed on December 4, 2008, and that violation posed
the risk for more than minimal harm.

The quality of care regulation requires that, based up the comprehensive assessment of a
resident, a facility must deliver necessary care and services to ensure that:

(1) A resident who enters the facility without an indwelling
catheter is not catheterized unless the resident’s clinical
condition demonstrates that catheterization was necessary;
and
(2) A resident who is incontinent of bladder receives
appropriate treatment and services to prevent urinary tract

'° The surveyors cited this deficiency at a scope and severity of D (CMS Ex. 1, at 49),
which means no actual harm with potential for more than minimal harm but not
immediate jeopardy. I need only find a potential for more than minimal harm to conclude
that there is a deficiency that provides a basis for imposition of an enforcement remedy.
However, for purposes of assessing the reasonableness of the remedy it is necessary to
consider the seriousness of the deficiency. A deficiency that causes actual harm is
generally considered to be more serious than one that does not. In this case, the
surveyor’s conclusion that there was no actual harm is clearly and plainly in error as a
matter of fact. The evidence shows open ulcers and they amount to actual harm because
any open wound has associated pain, risk for infection, and other complications.
16

infections and to restore as much normal bladder function as
possible.

42 CFR. § 483.25(d).

The surveyors allege in the SOD for the September 24, 2008 survey, that Petitioner
violated the regulation for the following reasons:

Petitioner failed to ensure that Residents 5, 6, and 27, who were
incontinent, received treatment and services necessary to prevent urinary
tract infections (UTIs); and

Petitioner failed to ensure that Resident 10 did not continue to have a
urinary catheter after the condition that required the catheter resolved.

The surveyors also alleged that nurse aides were unable to demonstrate competency in
skills and techniques related to catheter and perineal care. The surveyors allege that all
four residents suffered actual harm in the form of UTIs. CMS Ex. 1, at 55-56. I conclude
that the example cited by the surveyors related to Resident 5 establishes a violation of 42
C.F.R. § 483.25(d)(2). Thus, it is not necessary to discuss the examples cited by the
September 2008 survey related to Residents 6, 10, and 27.

The surveyors allege in the SOD for the survey completed on December 4, 2008, that
Petitioner violated the regulation because Petitioner failed to ensure that Resident 5’s
catheter tubing was maintained in the proper position. The surveyors allege that the
violation posed a risk for more than minimal harm. I agree that there was a deficiency
that posed a risk for more than minimal harm.

a. Resident 5 Facts

Resident 5 was 79 at the time of the survey. P. Ex. 12, at 8. She had an indwelling Foley
catheter. CMS Ex. 13, at 25, 30, 44; P. Ex. 12, at 10. The following diagnoses or history
were considered during her July 30, 2008, care plan conference: gastroesophageal reflux
disease (GERD), diabetes mellitus (DM), hypertension, history of urosepsis, history of
calculus of the kidney, spinal stenosis, muscle spasms, congestive heart failure,
hyperlipidemia, hypothyroidism, Parkinson’s Disease, depression, osteoarthritis,
peripheral neuropathy, urinary retention, seasonal allergies, anemia, insomnia, and
complications of the eye due to the DM. P. Ex. 12, at 13. The clinical record shows that
Resident 5 had laboratory testing to detect UTIs and that antibiotics were ordered as
treatment on December 6 and 21, 2007; March 4 and 21, 2008; June 17 and 20, 2008;
July 3, 2008; and August 28, 2008. CMS Ex. 13, at 33, 35-37, 39, 41, 46-47, 49-53, 55-
56, 59-60, 62-66, 69-71, 73; P. Ex. 12, at 32, 34-37, 47-49, 53-55, 63-65, 70-71, 87-92,
94, 96, 99-109. Petitioner’s clinical records include short-term care plans for each UTI.
17

Each short-term care plan includes the following interventions: administer the particular
antibiotic prescribed, encourage increased fluids, monitor for adverse signs and
symptoms (some specify to notify the physician if any observed), and provide good
perineal care and/or keep the resident clean and dry. P. Ex. 12, at 101-09. Petitioner also
offered evidence of two long-term care plans, one related to a problem of a staghorn
calculus and the other a risk for infection due to Foley catheter use and a history of urine
retention. P. Ex. 12, at 2,5. An Operative Report shows that on January 16, 2007,
Resident 5 had two renal stones or staghorn calculi removed, with no residual stones
observed. P. Ex. 12, at 20-22. Petitioner’s care plan dated January 20, 2007, identified
Resident 5 as at risk for increased pain due to the staghorn calculi and their removal as
well as urosepsis, among other things. The care planned interventions dated January 20,
2007, required the administration of various medications as ordered; comfort measures;
repositioning in bed, monitoring pain level, and notifying the physician if the
interventions were not effective. On October 10, 2007, a new intervention to administer
Actonel as ordered was added. On September 5, 2008, the intervention of giving Tylenol
as ordered was added. P. Ex. 12, at 2. The care plan for the infection risk due to the
Foley catheter and history of retention of urine is dated January 2007, and includes the
following interventions: monitor for signs and symptoms of infection and report any
noted; Foley catheter care daily with changes as necessary; good perineal care; good
hydration; and laboratory testing as ordered. The care plan includes an entry dated
October 18, 2007, that lists a particular size Foley catheter that was to be changed as
necessary. A subsequent entry on an uncertain date requires that antibiotics be
administered as ordered. The final entry appears to be dated June 2008, and specifies that
an antibiotic is to be administered for ten days followed by laboratory testing. P. Ex. 12,
at 5. Resident 5’s MDS with an assessment reference date of April 25, 2008, shows that
she had a UTI within the preceding thirty days. CMS Ex. 13, at 24-25. Resident 5’s
MDS with an assessment reference date of July 25, 2008, shows that she also had a UTI
within the thirty days preceding that assessment. CMS Ex. 13, at 29-30.

b. Resident 5 Analysis

I conclude that there is merit to the allegation that Petitioner failed to deliver necessary
care and services to prevent UTIs for Resident 5, who required a Foley catheter to
maintain continence. The regulation requires that Petitioner deliver treatment and
services necessary to ensure that an “incontinent” resident not develop UTIs. 42 C.F.R.
§ 483.25(d)(2). Resident 5 was assessed on both MDSs in the record as being continent
of bladder. However, the MDS form specifies that a resident should be assessed as
“continent” if the resident’s urine is controlled by use of a catheter, as it was in the case
of Resident 5. CMS Ex. 13, at 25, 30. I construe the requirement of 42 C.F.R.

§ 483.25(d)(2) broadly to oblige Petitioner to deliver necessary treatment and services to
ensure that a resident does not develop UTIs even though the resident is assessed as
continent, when that assessment is based on the use of a urinary catheter. A broad
construction is appropriate as it is undisputed that use of a urinary catheter poses an
18

increased risk for development of UTIs, just as incontinence poses an increased risk for
infection. Petitioner specifically recognized the increased risk for UTIs associated with
Foley catheter use by care planning for the risk in January 2007. P. Ex. 12, at 5. In this
case, Resident 5 was at increased risk for UTIs due to the continued use of the Foley
catheter. Petitioner recognized the risk and prepared the January 2007 care plan. P. Ex.
12, at 5.

The evidence shows that Resident 5 had multiple UTIs between December 6, 2007 and
August 28, 2008. However, the long-term care plan reflects no additional interventions
during the period except the administration of antibiotics and follow-up laboratory work.
P. Ex. 12, at 5. Similarly, the short-term care plans for each of the UTIs between
December 2007 and August 2008, include the nearly identical interventions. P. Ex. 12, at
101-09. Petitioner has provided me no evidence that the care planning team assessed the
effectiveness of chosen interventions to prevent UTIs or considered alternative
interventions to prevent UTIs. Thus, I conclude that Petitioner has failed to rebut the

CMS prima facie showing of a violation of 42 C.F.R. § 483.25(d)(2).

Petitioner argues that Resident 5 had a staghorn calculus that predisposed her to
colonization of bacteria that is generally asymptomatic and that the standard of care is not
to treat. P. Br. at 22-23. This argument verges on being frivolous. The evidence
Petitioner has produced shows that Resident 5 had two renal stones or staghorn calculus
removed in January 2007. The operative report for the procedure shows that no residual
stone or calculus remained after the operation. P. Ex. 12, at 20-22. Petitioner has
presented no credible objective evidence that shows that any physician examined
Resident 5 and diagnosed her with a staghorn after January 2007. Furthermore,
Petitioner’s clinical records cited above, including laboratory reports, show that Resident
5 was diagnosed with UTIs and treated with antibiotics. Thus, Petitioner’s argument that
Resident 5 did not have recurring UTIs but suffered from urinary tract bacterial
colonization due to staghorn calculus is not supported by the evidence of record.
Petitioner cites to the testimony of Thomas Woodbury, DO, Petitioner’s Medical Director
at page 746 of the transcript in support of the assertion that “Resident 5 never had
recurrent UTIs because the colonization of bacteria was due to her staghorn horn
calculus. I note that Dr. Woodbury is neither an urologist nor a nephrologist. P. Ex. 36,
at 9-12. I further note that Petitioner misrepresents Dr. Woodbury’s testimony. Dr.
Woodbury testified generally about staghorn calculus and bacteria, but he never testified
that Resident 5 redeveloped or had residual staghorn calculus following her surgery in
January 2007. Dr. Woodbury also never opined that the diagnoses of the multiple UTIs
between December 2007 and August 2008 were wrong or that the prescription of
antibiotics was in error. Tr. at 745-54. Dr. Woodbury testified that he was not Resident
5’s treating physician. Tr. at 772.

Petitioner also elicited testimony from John Randolph, MD. P. Ex. 36, at 13-15. Dr.
Randolph testified as to the standard of care for treatment of UTIs in elderly nursing
19

ome residents. He testified regarding conducting an appropriate history and physical,
and the need for confirmation by laboratory testing. He also testified that, although
00,000 colonies of bacteria is a UTI per se, a UTI is not diagnosed based only upon a
laboratory report but also upon signs and symptoms. He testified that asymptomatic
bacteriuria is common in the elderly and does not require treatment as a UTI. Tr. at 859-
76. Dr. Randolph testified that he never treated a patient at Petitioner’s facility. He
agreed that if a physician for a resident at Petitioner’s facility diagnosed a UTI and
prescribed antibiotics, he was not in a position to challenge that diagnosis. Tr. at 876.
Dr. Randolph did not testify specifically about Resident 5 or any other resident at
Petitioner’s facility.

Accordingly, I conclude that Petitioner was not in substantial compliance with program
participation requirements based on a violation of 42 C.F.R. § 483.25(d)(2) (Tag F315)
that caused Resident 5 actual harm in the form of multiple UTIs.

c. Facts Related to Resident 5 and the Survey of December 4, 2008.

The surveyors allege in the SOD for the survey that ended on December 4, 2008, that
there were four regulatory violations. However, only the alleged violation of 42 C.F.R.

§ 483.25(d) posed a risk for more than minimal harm to a resident. The surveyors allege
that Petitioner violated this regulation, because Petitioner failed to ensure that Resident
5’s urinary catheter tubing and collection bag were positioned so that the catheter drained
to the collection bag and not back to the bladder. CMS Ex. 68, at 3-4. According to the
SOD, a surveyor observed Resident 5 asleep in bed on December 1, 2008, with her
catheter tubing and urine collection bag hanging on the bed side-rail, which was above
the level of the resident’s bladder. The surveyor cited positioning of the catheter tube and
the collection bag as a deficiency because the position of the bag and tubing could allow
urine to flow back to the bladder and pose a risk for infection. Surveyor Nichols testified
at hearing that even with an anti-reflux valve, urine in the tubing between the bladder and
the valve could flow back to the bladder if the bag and tubing is placed above the level of
the bladder. Surveyor Nichols also pointed out that with the bag and tubing positioned
above the level of the bladder, the bladder could not empty properly. CMS Ex. 68, at 4;
Tr. at 86-88, 90.

Petitioner does not dispute that Surveyor Nichols observed that Resident 5’s urinary
catheter tubing and catheter bag were hung at a level above Resident 5’s bladder. P. Br.
at 29-30.

d. Analysis Related to Resident 5 and the Survey of December 4,
2008

Petitioner does not deny that urinary catheter tubing and the catheter bag should be hung
below the level of the resident’s bladder. P. Br. at 29-30. Petitioner argues that the error
20

was not its fault as the catheter bag was improperly positioned by a hospice aide, not a
facility staff member. P. Br. at 30. Petitioner cites no authority that recognizes a defense
that Petitioner is not responsible for care delivered in its facility by hospice aides who are
not employees. Petitioner argues that the facts reflect an isolated incident and no other
catheter bags or tubing were observed to be improperly positioned. P. Br. at 30.
Petitioner cites no authority for the proposition that a single violation must be excused.
Petitioner also cites no authority for the proposition that a single violation is not an
adequate basis for imposing an enforcement remedy, if the single violation has the
potential for causing more than minimal harm. Petitioner argues that Surveyor Nichols
did not realize that the catheter tubing and bag had an anti-reflux valve and that there was
no potential for harm. P. Br. at 30. Surveyor Nichols admitted at hearing that she did not
determine whether or not Resident 5’s catheter had an anti-reflux valve. However,
contrary to Petitioner’s assertion, Surveyor Nichols was familiar with anti-reflux valves,
their purpose, and that they were used at Petitioner’s facility. She opined that even with
an anti-reflux valve it was not safe to hang a catheter bag or tubing above the level of the
resident’s bladder. Tr. at 87-88. As a trained nurse, Surveyor Nichols was qualified to
render the opinion and Petitioner presented no evidence to rebut the opinion. I conclude
that the weight of the credible evidence shows that there is a risk for more than minimal
harm secondary to hanging a catheter bag or tubing above the level of the bladder. I also
conclude that Petitioner has neither rebutted the CMS prima facie showing nor

established an affirmative defense.

Accordingly, I conclude that Petitioner was not in substantial compliance with program
participation requirements due to a violation of 42 C.F.R. § 483.25(d)(2) (Tag F315) that
posed a risk for more than minimal harm to Resident 5. I further conclude that Petitioner
returned to substantial compliance on December 16, 2008, the date alleged by CMS, as
Petitioner has presented no evidence or argument to support a conclusion that it returned
to substantial compliance at an earlier date.

4. There is a basis for the imposition of enforcement remedies from
September 24 through December 15, 2008.

5. A CMP of $500 per day from September 24 through December 3,
2008 and $100 per day from December 4 through 15, 2008, a total
CMP of $36,700; and a DPNA from November 22, 2008 through
December 15, 2008, are reasonable enforcement remedies.

I have concluded that Petitioner was not in substantial compliance with program
participation requirements due to violations 42 C.F.R. § 483.25(c) and (d) and that the
violations posed a risk for more than minimal harm. Accordingly, there is a basis for
imposing enforcement remedies in this case. Ifa facility is not in substantial compliance
with program requirements, CMS has the authority to impose one or more of the
enforcement remedies listed in 42 C.F.R. § 488.406, including a CMP. CMS may impose
21

a daily CMP for the number of days that the facility is not in compliance or a per instance
CMP for each instance that a facility is not in substantial compliance. 42 C.F.R.

§ 488.430(a). The regulations establish two ranges for a daily CMP. 42 C.F.R.

§§ 488.408, 488.438. The lower range for a CMP — $50 per day to $3,000 per day — is
applicable when there is no immediate jeopardy, but there is either actual harm or a risk
for more than minimal harm. 42 C.F.R. § 488.438(a)(1)(ii).

If I conclude, as I have in this case, that there is a basis for the imposition of an
enforcement remedy and the remedy proposed is a CMP, my authority to review the
reasonableness of the CMP is limited by 42 C.F.R. § 488.438(e). The limitations are:

(1) I may not set the CMP at zero or reduce it to zero; (2) I may not review the exercise
of discretion by CMS in selecting to impose a CMP (or the CMS selection of any other
authorized remedy); and (3) I may only consider the factors specified by 42 C.F.R.

§ 488.438(f) when determining the reasonableness of the CMP amount. In determining
whether the amount of a CMP is reasonable, the following factors specified at 42 C.F.R.
§ 488.438(f) must be considered: (1) the facility’s history of noncompliance, including
repeated deficiencies; (2) the facility’s financial condition; (3) the seriousness of the
deficiencies as set forth at 42 C.F.R. § 488.404(b), the same factors CMS and/or the state
were to consider when setting the CMP amount; and (4) the facility’s degree of
culpability, including, but not limited to, the facility’s neglect, indifference, or disregard
for resident care, comfort, and safety and the absence of culpability is not a mitigating
factor. The factors that CMS and the state were required to consider when setting the
CMP amount and that I am required to consider when assessing the reasonableness of the
amount are set forth in 42 C.F.R. § 488.404(b): (1) whether the deficiencies caused (i) no
actual harm but had the potential for minimal harm, (ii) no actual harm but had the
potential for more than minimal harm, but not immediate jeopardy, (iii) actual harm that
is not immediate jeopardy, or (iv) immediate jeopardy to resident health and safety; and
(2) whether the deficiencies are isolated, constitute a pattern, or are widespread. My
review of the reasonableness of the CMP is de novo and based upon the evidence in the
record before me. 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, and in light of the above factors. I am not bound to defer to the CMS
determination of the reasonable amount of the CMP to impose but my authority is limited
by regulation as already explained. I am to determine whether the amount of any CMP
proposed is within reasonable bounds considering the purpose of the Act and regulations.
Emerald Oaks, DAB No. 1800, at 10 (2001); CarePlex of Silver Spring, DAB No. 1683,
at 14-16 (1999); Capitol Hill Cmty. Rehab. & Specialty Care Ctr., DAB No. 1629
(1997).

The evidence does not show a history of noncompliance by Petitioner that required the
imposition of enforcement remedies. The evidence of noncompliance introduced by
CMS shows prior instances that were apparently quickly corrected and required no
22

enforcement remedies to encourage Petitioner to return to substantial compliance. CMS
Ex. 62-64. CMS does not urge me to consider any history of noncompliance in
determining whether the proposed remedies are reasonable. CMS Br. at 30; CMS Reply
at 25. Petitioner has presented no evidence regarding its financial condition or an
inability to pay the CMP proposed. Therefore, I conclude that the amount of the CMP
would not cause a substantial financial burden to Petitioner. Crestview Parke Care Ctr.
v. Thompson, 373 F.3d 743, 756 (6th Cir. 2004). I conclude that Petitioner’s
noncompliance was serious and caused actual harm to residents. I also conclude that
Petitioner was culpable within the meaning of the regulations.

CMS proposes a $500 per day CMP from September 24 through December 3, 2008 and a
$100 per day CMP from December 4 through 15, 2008. Both amounts proposed are at
the low end of the range of authorized CMPs. I conclude the proposed CMPs are
reasonable in duration and amount. I also conclude that CMS was authorized to impose a
discretionary DPNA beginning November 22, 2008 and continuing until substantial
compliance was achieved on December 15, 2008, and that the DPNA was a reasonable
enforcement remedy. 42 C.F.R. §§ 488.402, 488.404, 488.406(a), 488.408.

Il. Conclusion

For the foregoing reasons, I conclude that Petitioner was not in substantial compliance
with program requirements from September 24, 2008 through December 15, 2008. A
basis exists to impose the following enforcement remedies, which are reasonable: a CMP
of $500 per day from September 24 through December 3, 2008 and $100 per day from
December 4 through 15, 2008, a total CMP of $36,700; and a DPNA from November 22,
2008 through December 15, 2008.

/s/
Keith W. Sickendick
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Robin H. Vaughan
(CCN: 10196011100088-001),

Petitioner
Vv.
Centers for Medicare and Medicaid Services.
Docket No. C-10-950
Decision No. CR2325

Date: February 18, 2011

DECISION

For the reasons set forth below, I grant the Centers for Medicare and Medicaid Services’
(CMS’s) motion for summary judgment. Palmetto GBA, the CMS contractor, had a
legitimate basis to determine that Robin H. Vaughan (Petitioner) did not meet the
requirements to enroll in the Medicare program as a non-physician practitioner of
neurophysiology. I therefore affirm the contractor’s determination to deny Petitioner’s
application.

I. Background

Petitioner states that he holds a Masters Degree in audiology, in which he is currently
licensed, and a Ph.D. in neurophysiology, which does not have a licensing program.
Hearing Request (HR). Petitioner seeks to enroll in the Medicare program as a non-
physician practitioner, specifically as a neurophysiologist, to perform and bill for services
including intraoperative neurophysiologic monitoring and electrodiagnositcs. Jd. In May
2010, Petitioner filed an enrollment application. CMS Ex. 2 at 1-3. The CMS contractor
denied his application and explained that Petitioner’s specialty is not covered under the
Medicare program. CMS. Ex. 3, at 1. Upon reconsideration, the contractor again denied
Petitioner’s application for enrollment and reiterated that a neurophysiologist was not
recognized as a supplier type eligible to enroll and bill for services rendered to Medicare
patients. CMS Ex. 5 at 1 (citing 42 C.F.R. § 405.400). Pursuant to 42 C.F.R. § 498.40,
Petitioner timely filed a request for an Administrative Law Judge (ALJ) hearing by letter
dated August 25, 2010. With Petitioner’s hearing request, he included thirteen
supplemental pages, which I have marked as Petitioner’s Exhibit 1 (P. Ex. 1).

This case was originally assigned to Board Member Leslie A. Sussan, pursuant to

42 C.F.R. § 498.44, which permits a Member of the Departmental Appeals Board (Board)
to hear appeals under Part 498. The case was subsequently transferred to me for
decision, and the parties were notified by letter dated October 25, 2010. Pursuant to the
September 2, 2010 Acknowledgement and Pre-Hearing Order, CMS filed a motion for
summary judgment and supporting memorandum (CMS Br.) on October 22, 2010. CMS
accompanied its submission with CMS Exhibits 1-6. On November 12, 2010, Petitioner
filed a letter in reply, stating that he did “not have any additional documents or exhibits to
add to [his] appeal ....” In the absence of objection, I receive into the record of this case
P. Ex. | and CMS Exs. 1-6.

II. Issue

The issue in this case is whether CMS is authorized to deny Petitioner’s
application for enrollment as a supplier in the Medicare program as a non-
physician practitioner.

Ill. Applicable Standard
The Board stated the standard 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. . .. 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... . 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. . . . 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.

Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300, at 3 (2010) (citations omitted).
The role of an ALJ in deciding a summary judgment motion differs from the ALJ’s role
in resolving a case after a hearing. The ALJ should not assess credibility or evaluate the
weight of conflicting evidence. Holy Cross Vill. at Notre Dame, Inc, DAB No. 2291, at 5
(2009). The Board has further stated, “[i]n addition, it is appropriate for the tribunal to
consider whether a rational trier of fact could regard the parties’ presentation as sufficient
to meet their evidentiary burden under the relevant substantive law.” Dumas Nursing and
Rehab., L.P., DAB No. 2347, at 5 (2010).

IL. Findings of fact, Conclusions of Law, and Discussion
I make a single finding and conclusion set out below:

CMS was authorized to deny Petitioner’s application for enrollment
because he was not eligible to enroll in the Medicare program

Petitioner appeals the contractor’s determination denying his application to enroll in the
Medicare program as supplier of neurophysiology services. HR. As noted, the contractor
denied his application, stating that neurophysiology was not a recognized supplier type
eligible to enroll and bill for services rendered to Medicare patients. CMS Ex. 5 at 1
(citing 42 C.F.R. § 405.400).

Part B of the Medicare program is a voluntary supplemental insurance program covering
outpatient services. Social Security Act (Act) §§ 1831-1848, 42 U.S.C. §§ 1395j—
1395w-4. The program provides reimbursement for physician services and certain
“medical and other health services” provided by non-physician practitioners, including
physician assistants, nurse practitioners, physical therapists, occupational therapists,
clinical nurse specialists, certified nurse-midwives, clinical social workers, clinical
psychologists, registered dietitians or nutrition professionals, anesthesiology assistants,
and speech language pathologists and audiologists. See Act § 1861(s), 42 U.S.C. §
1395x(s); Act § 1842(b)(18)(C), 42 U.S.C. § 1395u(b)(18)(C); Act § 1861(bb), 42 U.S.C.
§ 1395x(bb); Act § 1861(Il), 42 U.S.C. § 1395x(Il). The entities or individuals furnishing
such health care services are known as “suppliers.” 42 C.F.R. § 400.202.

The Act requires the Secretary to issue regulations establishing a process for the
enrollment of suppliers. Act § 1866(j). To receive payment, a supplier must be enrolled
in the Medicare program. 42 C.F.R. § 424.505. The purpose of the Medicare Part B
enrollment process is to determine a supplier’s eligibility to bill and receive Medicare
payment for health care services. 42 C.F.R. § 424.502 (defining the term “enrollment” to
mean a process for establishing eligibility to submit payment claims to Medicare). CMS
may deny a prospective supplier enrollment if Part B does not authorize payment for
services. 42 C.F.R. § 424.505. See Peter McCambridge, C.F.A., DAB CR1961 (2009),
aff'd, DAB No. 2290 (2009). It is appropriate to deny an enrollment application if a
prospective supplier is not found in compliance with the enrollment requirements. 42
C.F.R. § 424.530(a)(1).
The Medicare Program Integrity Manual (MPIM), CMS’s guidance for affiliated
contractors, lists the types of non-physician practitioners that may be enrolled in the
Medicare program as suppliers, referencing the statutory and regulatory basis for
Medicare payment to these suppliers.' In accordance with Federal regulations, a
neurophysiologist is not included among the types of non-physician practitioners
authorized to receive payment for services as a supplier under the Medicare program.
MPIM, Chpt. 10, Section 12.4; see 42 CFR § 405.400; see also 42 CFR §§ 424.5, 410.1 —
410.175

Petitioner recognizes that his profession is not an area the Medicare program is
authorized to cover. In his hearing request, Petitioner states:

I did not dispute that neurophysiology is not included in that list [of non-
physician practitioners]. My point is simple, once upon a time a physician
assistant or nurse practitioner appeals to Medicare to become a Non
Physician Practitioner and it was granted. There was a process that that
application went through and was granted. I am asking for that same
process.

I do not question Petitioner’s reported credentials or that Petitioner provides a valuable
service to his clients. However, I have no authority, nor does CMS through this
enrollment appeals process, to grant Petitioner the remedy he seeks. The purpose of the
Medicare Part B enrollment process is to determine a supplier’s eligibility to bill and
receive Medicare payment for health care services. 42 C.F.R. § 424.502; see
McCambridge, DAB No. 2290, at 4. This enrollment appeals process is not the proper
forum for challenging current regulation or policy. Neither the Board nor I can create or
dictate such a policy. The authority to create coverage and payment policy, as embodied
in the Medicare statute and regulations, instead rests with Congress and CMS. My role is
to apply the Medicare laws as they exist, and I see nothing in those laws that authorize
CMS to pay for Petitioner’s services as a neurophysiologist. See McCambridge, DAB
No. 2290, at 7-8.

I must apply the regulations as they are stated. The applicable regulations do not
authorize CMS to enroll Petitioner in the Medicare program as a neurophysiologist.
Petitioner points to no source of authority for me to grant an exemption on policy or
equitable grounds. Moreover, I have no authority to declare the statute or the regulation

' On July 30, 2010, the provisions in Chapter 10 of the MPIM were relocated to Chapter
15 of the MPIM. See Chapter 10 Manual Redesign, CMS Pub. 100-08, C.R. 6938, July
15, 2010, available at http://www.cms.gov/transmittals/downloads/ R347PL.pdf. In this
decision, however, I cite to the MPIM provisions as they existed during the relevant
period.
invalid or ultra vires. 1866[CPayday.com, L.L.C., DAB No. 2289, at 14 (2009) (“An
ALJ is bound by applicable laws and regulations and may not invalidate either a law or
regulation on any ground.”).

Ill. Conclusion

It is undisputed that Petitioner does not qualify as a non-physician practitioner supplier
under the regulation. I therefore grant the CMS motion for summary judgment and
affirm the reconsideration to deny Petitioner’s request to participate in the Medicare
program as neurophysiologist.

/s/
Joseph Grow
Administrative Law Judge