Department of Health and Human Service

DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

)
In the Case of: )
) Date: May 22, 2009
Carver Living Center (CCN: 34-5434), )
)
Petitioner, ) Docket Nos. C-07-316
) Decision No. CR1954
v. )
)
Centers for Medicare & Medicaid Services. )
)
DECISION

Petitioner violated 42 C.F.R. § 483.25(h)(1)' on November 14, 2006, and did not return
to substantial compliance with program participation requirements until January 26,
2007. The civil money penalty (CMP) proposed by the Centers for Medicare & Medicaid
Services (CMS) is not reasonable. A CMP of $3050 per day from November 14, 2006
through December 7, 2006, and a CMP of $50 per day from December 8, 2006 through
January 24, 2007, a total CMP of $75,600, is reasonable.

I. Background

Petitioner, located in Durham, North Carolina, is authorized to participate in Medicare as
a skilled nursing facility (SNF) and in the North Carolina Medicaid program as a nursing
facility (NF). Petitioner was subject to surveys by the North Carolina Department of
Health and Human Services, Division of Facility Services (the state agency), that were
completed on October 12, 2006, November 29, 2006, December 21, 2006 and January
25, 2007.

' All references are to the Code of Federal Regulations (C.F.R.) in effect at the time of
the survey unless otherwise indicated.
The state agency notified Petitioner by letter dated October 18, 2006, that CMS would be
required to deny payment for new admissions to Petitioner effective January 12, 2007,
based upon the findings of deficiency from the survey ended on October 12, 2006, if
Petitioner did not return to substantial compliance before that date. The Centers for
Medicare & Medicaid Services (CMS) notified Petitioner by letter dated January 16,
2007, based upon the findings of the survey completed on December 21, 2006, that it was
imposing a CMP of $3050 per day from November 14, 2006 through December 20, 2006,
and a CMP of $100 per day from December 21, 2006, until the date on which Petitioner
returned to substantial compliance; a denial of payment for new admissions (DPNA)
effective January 12, 2007, if Petitioner did not return to substantial compliance prior to
that date; and termination of Petitioner’s provider agreement effective April 12, 2007, if
Petitioner did not return to substantial compliance before that date. CMS also advised
Petitioner that its authority to conduct a Nurse Aide Training and Competency Evaluation
Program (NATCEP) had to be withdrawn for a period of two years.”

Petitioner requested a hearing by pleading dated March 15, 2007. The request for hearing
was docketed and assigned to me for hearing and decision on March 20, 2007, and a
Notice of Case Assignment and Prehearing Case Development Order (Prehearing Order)
was issued at my direction.

A hearing was convened on November 5, 2007, in Raleigh, North Carolina. A 207-page
transcript of the hearing was prepared. CMS offered, and I admitted, CMS exhibits
(CMS Exs.) 1, 5-7, 13-21, and 24. Tr. 29, 57, 86. Petitioner offered, and I admitted,
Petitioner’s exhibits (P. Exs.) 1, 4-6, 9, 11-14, and 17-25. Tr. 34. Testifying for CMS
was Kathleen Dunn, R.N., a state agency surveyor. Testifying for Petitioner were Jamie
Royster and Tonya Mitchell, facility employees who both drove Petitioner’s van. CMS
and Petitioner filed post-hearing briefs and post-hearing reply briefs (CMS Br. and P. Br.
and CMS Reply and P. Reply, respectively).

> Petitioner did not have a NATCEP. Transcript (Tr.) at 12.
IL. Discussion
A. Issues
The issues in this case are:
Whether there is a basis for the imposition of an enforcement remedy; and,
Whether the remedy imposed is reasonable.
B. Applicable Law

The statutory and regulatory requirements for participation by a long-term care facility
are found at sections 1819 (SNF) and 1919 (NF) of the Act and at 42 C.F.R. Part 483.
Section 1819(h)(2) of the Act vests the Secretary of Health and Human Services (the
Secretary) with authority to impose enforcement remedies against a SNF for failure to
comply substantially with the federal participation requirements established by sections
1819(b), (c), and (d) of the Act.> Pursuant to section 1819(h)(2)(C), the Secretary may
continue Medicare payments to a SNF not longer than six months after the date the
facility is first found not in compliance with participation requirements. Pursuant to
section 1819(h)(2)(D), if a SNF does not return to compliance with participation
requirements within three months, the Secretary must deny payments for all individuals
admitted to the facility after that date — commonly referred to as the mandatory or
statutory DPNA. In addition to the authority to terminate a noncompliant SNF’s
participation in Medicare, the Act grants the Secretary authority to impose other
enforcement remedies, including a discretionary DPNA, 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 facility that is not complying substantially with federal
participation requirements. “Substantial compliance means a level of compliance with
the requirements of participation such that any identified deficiencies pose no greater risk
to resident health or safety than the potential for causing minimal harm.” 42 C.F.R.

> Section 1919(h)(2) of the Act gives similar enforcement authority to the states to
ensure that NFs comply with their participation requirements established by section
1919(b), (c), and (d) of the Act.
§ 488.301 (emphasis in original). A deficiency is a violation of a participation
requirement established by sections 1819(b), (c), and (d) of the Act or the Secretary’s
regulations at 42 C.F.R. Part 483, Subpart B. Facilities that participate in Medicare may
be surveyed on behalf of CMS by state survey agencies in order to determine whether the
acilities are complying with federal participation requirements. 42 C.F.R. §§ 488.10-
488.28, 488.300-488.335. The regulations specify the enforcement remedies that CMS
may impose if a facility is not in substantial compliance with Medicare requirements.

42 CFR. § 488.406.

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

The Act and regulations make a hearing before an administrative law judge (ALJ)
available to a long-term care facility against which CMS has determined to impose an
enforcement remedy. Act § 1128A(c)(2); 1866(h); 42 C.F.R. §§ 488.408(g);
498.3(b)(13). The hearing before an ALJ is a de novo proceeding. Anesthesiologists
Affiliated, et al, DAB CR65 (1990), aff'd, 941 F.2d 678 (8th Cir. 1991); Emerald Oaks,
DAB No. 1800, at 11 (2001); Beechwood Sanitarium, DAB No. 1906 (2004); Cal Turner
Extended Care Pavilion, DAB No. 2030 (2006), The Residence at Salem Woods, DAB
No. 2052 (2006). A facility has a right to appeal a “certification of noncompliance
leading to an enforcement remedy.” 42 C.F.R. § 488.408(g)(1); see also 42 C.F.R.

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

§ 488.408(g)(2). A facility may only challenge the scope and severity level of
noncompliance found by CMS if a successful challenge would affect the range of the
CMP that could be imposed by CMS or impact the facility’s authority to conduct a
NATCEP. 42 C.F.R. §§ 498.3(b)(14) and (d)(10)(i). The CMS determination as to the
level of noncompliance “must be upheld unless it is clearly erroneous” (42 C.F.R.

§ 498.60(c)(2)), including the finding of immediate jeopardy. Woodstock Care Center,
DAB No. 1726, at 9, 39 (2000), aff'd, Woodstock Care Center v. Thompson, 363 F.3d
583 (6th Cir. 2003). The Departmental Appeals Board (the Board) has long held that the
net effect of the regulations is that a provider has no right to challenge the scope and
severity level assigned to a noncompliance finding, except in the situation where that
finding was the basis for an immediate jeopardy determination. See, e.g., Ridge Terrace,
DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750 (2000). Review of a CMP by
an ALJ is subject to 42 C.F.R. § 488.438(e).

The standard of proof or quantum of evidence required is a preponderance of the
evidence. CMS has the burden of coming forward with the evidence and making a prima
facie showing of a basis for imposition of an enforcement remedy. Petitioner bears the
burden of persuasion to show by a preponderance of the evidence that it was in
substantial compliance with participation requirements or any affirmative defense. See
Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Ctr.
v. United States Dep’t of Health and Human Services, Health Care Fin. Admin., No. 98-
3789 (GEB), slip op. at 25 (D.N.J. May 13, 1999); Cross Creek Health Care Center,
DAB No. 1665 (1998); Emerald Oaks, DAB No. 1800; Batavia Nursing and
Convalescent Center, DAB No. 1904 (2004), aff'd, Batavia Nursing & Convalescent Ctr.
v. Thompson, 129 F. App’x. 181 (6th Cir. 2005); Batavia Nursing and Convalescent Inn,
DAB No. 1911 (2004).

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

The parties stipulated prior to hearing that the survey completed on November 29, 2006,
alleged violations of 42 C.F.R. §§ 483.15(e)(1) (F Tag 246) and 483.25(a)(3) (F Tag
312). Joint Stipulation (Jt. Stip.) 45. The alleged violation of 42 C.F.R. § 483.25(h)(1)
from the December 2006 survey resulted from a complaint to the state agency. Tr. 50-51,
53. Petitioner requested review of the deficiencies from the November and December
surveys in its request for hearing but did not request review of the findings of deficiency
from the surveys that ended October 12, 2006 or January 25, 2007. The parties stipulated
at hearing that no remedy proposed by CMS was based upon the alleged deficiencies
from the November survey and that those deficiencies are not at issue before me. Tr. 10-
12; P. Br. at 1-2. The parties stipulated that a DPNA was in effect January 16 through 25,
2007 (Tr. 13), however the CMS notice indicates that the DPNA actually began on
January 12, 2007 (CMS Ex. 5, at 3). The record reflects that the DPNA that began on
January 12, 2007 was actually a mandatory or statutory DPNA that was required to be
imposed three months after the findings of deficiency from the survey that ended on
October 12, 2006, if Petitioner did not return to substantial compliance prior to the end of
the three-month period. CMS Ex. 5; CMS Ex. 22 (not admitted); P. Ex. 6. The parties
stipulated that the facility returned to substantial compliance with program participation
requirements effective January 26, 2007, and the termination remedy was not effectuated.
Tr. 11- 14; P. Ex. 25; Jt. Stip. ¥ 12.
The parties stipulated: that, based upon the alleged violation of 42 C.F.R. § 483.25(h)(1)
from the survey completed on December 21, 2006, CMS imposed a CMP of $3050 per
day from November 14, 2006 through December 20, 2006; that the state agency
surveyors found that immediate jeopardy was abated as of December 21, 2006; and that
the CMP was reduced to $100 per day from December 21, 2006 to January 24, 2007.

The parties agreed that the alleged violation of 42 C.F.R. § 483.25(h)(1), and the CMPs
from November 14, 2006 through January 24, 2007 based on that deficiency, are the only
deficiency and remedies at issue before me. Jt. Stip. Jf 9-13; Tr. 24-28; P. Br. at 1-2.
Petitioner did not challenge the deficiency finding from a revisit survey completed on
January 25, 2007 or the one-day, $150 CMP based on that deficiency. Tr. 26. Petitioner
does not challenge or discuss the DPNA in either of its briefs. Although Petitioner
alleges in its post-hearing brief that it corrected the alleged violation of 42 C.F.R.

§ 483.25(h)(1) by December 4, 2006, and that no CMP based upon that deficiency should
have continued beyond that date (P. Br. at 12-15; Tr. 38), Petitioner does not dispute
before me that it did not return to substantial compliance with program participation
requirements prior to January 26, 2007, or that it was properly subject to the DPNA.

1. Petitioner violated 42 C.F.R. § 483.25(h)(1).
(a) Facts

Resident 4 was 76 years of age at the time of the accident that is the subject of the
deficiency citation. Her diagnoses included diabetes mellitus, congestive heart failure,
end stage renal failure with dialysis, peripheral vascular disease, and hypertension; she
also had bilateral above the knee amputations, almost no lap, and was wheelchair bound.
CMS Ex. 13, at 1; Tr. 184-85; CMS Ex. 17; P. Ex. 20. Resident 4 did not suffer from
long or short-term memory loss and was independent in daily decision-making. CMS Ex.
13, at 2; Tr. 63.

Resident 4 was required to undergo dialysis treatments three times a week as a result of
her diabetes and Petitioner was responsible for transporting Resident 4 to and from her
dialysis appointments. During transport, Resident 4 was secured in a facility van while
sitting in her own wheelchair. On November 14, 2006, Resident 4 and three other facility
residents were being transported in the facility van after Resident 4 had been picked up at
the dialysis center. The van was driven by certified nursing assistant (CNA) Jamie
Royster. Transportation aide CNA Arnecia Langley accompanied Ms. Royster in the
van. Ms. Royster placed the van wheelchair restraint system shoulder harness across
Resident 4’s torso after securing Resident 4’s wheelchair to the facility van by locking
four wheelchair belts and floor straps (two in front, two in back). The shoulder harness
came across Resident 4’s left shoulder, across her torso, through the space between the
right wheelchair arm and the seat, and affixed to the floor. Ms. Royster did not place a
lap belt across Resident 4’s lower torso as a lap belt was not part of the van’s restraint
system. Resident 4 was not wearing a wheelchair lap belt and Ms. Royster was unaware

that she had such a belt in her wheelchair.* Ms. Royster was forced to stop suddenly in
order to avoid hitting another vehicle that cut in front of the van and then abruptly
stopped in order to turn left. After the sudden stop, Ms. Langley observed Resident 4 had
slid from her wheelchair to the floor of the van. Ms. Langley told Ms. Royster to stop the
van and Ms. Royster pulled the van to the side of the road, turned on the hazard lights,
and went back to check on Resident 4. Resident 4 was sitting straight up on the floor.
The shoulder harness was still secured after Resident 4 left her seat. Ms. Royster asked
Resident 4 if she was o.k. and if she was getting her oxygen and Resident 4 indicted she
was not injured, other than scraping her stump. Ms. Royster and Ms. Langley lifted
Resident 4 to the edge of her chair and she “scooted” herself back into her chair. Ms.
Royster strapped Resident 4 down and proceeded back to the facility. Resident 4 told
Ms. Royster upon their return that her leg hurt, and Resident 4 was noted to have an
abrasion on her right stump. Upon returning to the facility, Resident 4 complained of hip
pain and was sent to the hospital. At the hospital, it was determined that Resident 4 had
sustained a hip fracture. Given Resident 4’s medical conditions, surgery to fix the hip was
tuled out. Resident 4 sustained pain and depression as a result of her injury. Tr. 63, 146-
49, 157-59, 171, 172, 174-75, 178; CMS Ex. 17, at 5-8, 12-15, 20-22, 38-43; P. Exs. 13,
14, 15, 16, 19, 20; P. Ex. 23, at 1; P. Br. at 5-6.

The unrebutted evidence is that the restraint system in the facility van had not been
recalled, was not broken, was not otherwise damaged, and was reliable. Tr. 120, 189.
After November 14, 2006, the facility van was sent out for maintenance and installation
of a new restraint system. Tr. 146, 185-86; P. Exs. 21, 22. While the van was being
serviced, an independent transportation company transported Petitioner’s residents and
Petitioner’s drivers did not transport residents. Tr. 160, 185-87. On December 5, 2006,
the facility’s transportation staff received in-service training on the new restraint system,
which consisted of an instructional video and quiz provided by the manufacturer
regarding proper use of the seatbelt system and a hands-on demonstration session during
which Petitioner’s transportation staff had to demonstrate their ability to properly use the
system to secure a wheelchair and resident. Tr. 160; P. Exs. 10, 11, 24. Jamie Royster
and two transportation aides viewed the video and participated in the hands-on in-service
training on December 5, 2006. Tr. 160. Tonya Mitchell, a back-up driver, attended the
December 5, 2006 hands-on training with the other employees, but did not view the video
until December 21, 2006. Tr. 180, 187, 192; P. Ex. 24. However, Ms. Mitchell had

+ Ina statement dated January 31, 2007, Ms. Royster stated that she did secure Resident
4’s wheelchair lap belt. P. Ex. 14, at 1, ff] 8, 15. However, the credible evidence is that
she was not aware the resident had a lap belt in her wheelchair. Tr. 148-49, 151-52, 154-
57, 171-72, 177.

worked with a restraint system similar to the new restraint system with a prior employer.
Tr. 186-88, 192. When Ms. Mitchell viewed the video on December 21, 2006, the only
information from the video with which she was not familiar was the section on storage of
the system. P. Exs. 11, 12. Petitioner does not remove and store the restraint system.

P. Ex. 12. The facility van was returned to the facility on December 8, 2006, following
installation of the new restraint system and repair of the mechanical lift. P. Ex. 22.

(b) Analysis

CMS urges that the facts establish a prima facie showing that Petitioner violated

42 C.F.R. § 483.25(h)(1) on November 14, 2006. I agree. CMS can point to no statutory
or regulatory requirement, state or federal, which specifies the type of restraints to be
used for transportation of people in wheelchairs. CMS Ex. 24, at 6. However, it is not
necessary for CMS to cite a specific statutory or regulatory requirement for the safe
transport of people in wheelchairs. Participating facilities, such as Petitioner, agree to
provide each resident “the necessary care and services to attain or maintain the highest
practicable physical, mental, and psychosocial well-being” (42 C.F.R. § 483.25) based
upon a comprehensive assessment of the needs of the resident and the plan of care the
care plan team develops as required by 42 C.F.R. § 483.20. The specific quality of care
requirement at issue in this case requires a facility to ensure that “[t]he resident
environment remains as free of accident hazards as is possible... .” 42 C.F.R.

§ 483.25(h)(1). The State Operations Manual (SOM), CMS’s guidance to surveyors,
instructs surveyors that the intent of section 483.25(h)(1), is that the facility prevents
accidents by providing “an environment that is free from accident hazards over which the
facility has control.” SOM, Appendix (App.) PP, F Tag 323. The Board has provided
some further interpretative guidance for adjudicating alleged violations of the section:

The standard in section 483.25(h)(1) itself - that a facility “ensure that the
environment is as free of accident hazards as possible” in order to meet the
quality of care goal in section 483.25 -- places a continuum of affirmative
duties on a facility. A facility must determine whether any condition exists
in the environment that could endanger a resident’s safety. If so, the
facility must remove that condition if possible, and, when not possible, it
must take action to protect residents from the danger posed by that
condition. [Footnote omitted.] Ifa facility has identified and planned for a
hazard and then failed to follow its own plan, that may be sufficient to
show a lack of compliance with [the] regulatory requirement. In other
cases, an ALJ may need to consider the actions the facility took to identify,
remove, or protect residents from the hazard. Where a facility alleges (or
shows) that it did not know that a hazard existed, the facility cannot prevail
if it could have reasonably foreseen that an endangering condition existed
either generally or for a particular resident or residents.
Maine Veterans’ Home — Scarborough, DAB No. 1975, at 6-7 (2005); see Liberty
Nursing and Rehabilitation Center-Mecklenberg County, DAB No. 2095 (2007);
Sunbridge Care and Rehabilitation for Pembroke, DAB No. 2170 (2008).

In this case, Resident 4 required transportation to her dialysis appointments. Petitioner
undertook to provide transportation for Resident 4 using its van. Petitioner’s van was
thus part of Resident 4’s environment and Petitioner was obliged to ensure that
environment was as free of accident hazards as possible. Petitioner argues that the
incident with Resident 4 being ejected from her wheelchair was not foreseeable, i.e. it
was not foreseeable that the van driver would have to stop abruptly to avoid hitting a car
that cut her off and it was not foreseeable that Resident 4 would be ejected from her
wheelchair when the van stopped abruptly. Petitioner’s arguments are not persuasive. It
is common knowledge and commonly accepted that accidents occur when one is driving
or riding in a vehicle on the public streets and highways. Thus, it is readily foreseeable
that one riding as a passenger may be involved in an accident involving the vehicle in
which the person is riding. Based upon the fact that there was a foreseeable risk and an
accident occurred, I conclude that there has been a prima facie showing of a violation.
The burden of persuasion is thus upon Petitioner to show by a preponderance of the
evidence that it was in substantial compliance or had an affirmative defense.

I conclude that Petitioner has failed to meet its burden. Given that Resident 4 was a
bilateral amputee with almost no lap, it was incumbent upon Petitioner to plan for her
safe transport when riding in the facility van. The evidence shows that Petitioner’s van
was equipped with a wheelchair harness system that included a shoulder belt but not a lap
belt. While such a system may have been safe for an individual with legs, Petitioner has
not adduced any evidence that it specifically planned for the safe transport of this
bilateral amputee, instead asserting that the restraint system was not used inconsistently
with manufacture’s instructions, was in good repair, was used correctly, and Resident 4
ad traveled safely in the van in the past, had good balance and coordination, and did not
ike to wear her wheelchair lap belt and did not wear it as a matter of personal dignity.

P. Br. at 8. Petitioner’s arguments do not establish that the facility appropriately assessed
Resident 4’s needs for safe transport, i.e. what measures needed to be observed and
implemented to ensure she was not thrown about in the vehicle in the event of a crash or
sudden stop. Petitioner’s arguments also do not show that Petitioner actually planned for
Resident 4’s safe transport given her unique needs. Furthermore, Resident 4’s
wheelchair, which the evidence shows was securely fastened to the floor of the van and
apparently moved little if at all during the accident, had a seat lap belt that was not
fastened across the resident’s lap. One may infer from the presence of the lap belt in the
wheelchair that one intended function was to prevent the user from coming out of the seat
of the chair. The lap belt was not used and Resident 4 was ejected from the wheelchair
during a sudden stop. Use of the wheelchair lap belt was a reasonable step to mitigate the
hazards associated with being transported, a step Petitioner failed to take.

10

Accordingly, I conclude that Petitioner has failed to show that it acted reasonably to
ensure that Resident 4’s environment was as free of accident hazards as possible, a
violation of 42 C.F.R. § 483.25(h)(1).

2. Petitioner’s violation of 42 C.F.R. § 483.25(h)(1) posed immediate
jeopardy.

3. The finding of immediate jeopardy was not clearly erroneous.
4. Immediate jeopardy was abated on December 8, 2006.

Once CMS determines that a Petitioner’s noncompliance poses immediate jeopardy, it is
Petitioner’s burden to prove that determination to be clearly erroneous. The Board has
observed repeatedly that the “clearly erroneous” standard imposes on facilities a “heavy
burden” to show no immediate jeopardy, and has sustained determinations of immediate
jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’
that immediate jeopardy exists.” Barbourville Nursing Home, DAB No. 1962, at 11
(2005), citing Florence Park Care Center, DAB No. 1931, at 27-28 (2004) (citing
Koester Pavilion, DAB No. 1750 (2000)). In this case, Petitioner is permitted to
challenge CMS’s finding of immediate jeopardy because, if decided favorably to
Petitioner, the decision could impact the range of CMP applicable. 42 C.F.R.

§ 498.3(b)(14).

Petitioner has not proved that CMS’s finding of immediate jeopardy was clearly
erroneous during the period November 14, 2006 through December 7, 2006. Resident 4
suffered a serious injury on November 14, 2006, due to Petitioner’s failure to ensure that
she was properly secured and safely transported in the facility van. Resident 4 suffered a
ip fracture, a particularly serious injury in the elderly, and the fracture could not be
corrected surgically given Resident 4’s medical conditions. Resident 4, who was alert
and oriented, suffered pain and depression, also significant injuries. Tr. 59-62; CMS Ex.
17, at 20-22, 41.

Petitioner did show that the jeopardy was removed or abated effective December 8, 2006,
when the new restraint system with an integrated lap belt was installed in the facility’s
van and the van was returned to Petitioner. Staff had been trained on December 5, 2006
to use the new restraint system and had demonstrated their ability to use the new system.
The evidence shows that back-up driver Tonya Mitchell did not view the video regarding
the new system on December 5, 2006 with the other driver and aides. But the evidence
that Ms. Mitchell had prior experience with a similar system and was able to demonstrate
her competence to use it is sufficient for me to conclude that jeopardy was abated when
the van was returned on December 8. The surveyors confirmed during the survey that
Ms. Mitchell competently demonstrated use of the restraint system. CMS Ex. 13, at 9-10.
The unrebutted evidence shows that the only additional information the video provided
11

Ms. Mitchell when she viewed it during the morning of December 21, 2006, was how to
store the system, information that has nothing to do with the safe transport of residents,
particularly as the evidence shows that the system was not removed and stored by
Petitioner’s staff. Tr. 187-88; P. Ex. 12. Thus, Petitioner has shown that the immediate
jeopardy was abated as of December 8, 2006, and immediate jeopardy was clearly
erroneous after that date.

Petitioner argues that immediate jeopardy was actually abated on December 4, 2006,
when the facility van was sent out to have the new restraint system installed and Resident
4 was transported by a contractor. P. Br. at 3, 12. Surveyor Dunn seemed to agree with
Petitioner that immediate jeopardy may have been abated for the period when Resident 4
was being transported by a contractor. Tr. 101. However, Petitioner has not presented
evidence from which I can find that the contractor actually provided transportation of
Resident 4 in a manner to minimize the risk of harm to residents due to accidental injury.
There is no evidence as to the type of restraint system the contractor used for Resident 4’s
transport or that Petitioner assessed whether safe transport would be provided by the
contractor for Resident 4. Accordingly, I cannot conclude that Petitioner took reasonable
steps to mitigate the risk to Resident 4 of accidental injury during transportation away
from the facility by the contractor or that immediate jeopardy was abated as a result.

5. There is a basis for the imposition of an enforcement remedy.

6. The proposed CMPs of $3050 per day for the period November 14,
2006 through December 20, 2006 and $100 per day for the period
December 21, 2006 through January 24, 2007, are not reasonable.

7. CMPs of $3050 per day for the period November 14, 2006 through
December 7, 2006, and $50 per day for the period December 8, 2006
through January 24, 2007, are reasonable.”

I have concluded that Petitioner violated 42 C.F.R. § 483.25(h)(1). Hence, there is a
basis for the imposition of an enforcement remedy. The issues that still require resolution
are the duration of the noncompliance with the regulatory provision and the reasonable
amount for any CMPs imposed.

* As already discussed, the parties stipulated the CMP was increased to $150 for January
25, 2007, based upon a different regulatory violation that caused Petitioner not to be in
substantial compliance on that date.
12

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

§ 488.406, including a CMP. CMS may impose a CMP for the number of days that the
facility is not in compliance or for each instance that a facility is not in substantial
compliance. 42 C.F.R. § 488.430(a).° There are two ranges for per day CMPs.

42 C.F.R. §§ 488.408, 488.438. The upper range of CMP, from $3050 per day to
$10,000 per day, is for deficiencies that constitute immediate jeopardy to a facility’s
residents and, in some circumstances, for repeated deficiencies. 42 C.F.R. §§
488.438(a)(1)(i) & (d)(2). The lower range of CMP, from $50 per day to $3000 per day,
is for deficiencies that do not constitute immediate jeopardy, but either cause actual harm
to residents or cause no actual harm but have the potential for causing more than minimal
harm. 42 C.F.R. § 488.438(a)(1)(ii).

Petitioner was in violation of 42 C.F.R. § 483.25(h)(1) beginning on November 14, 2006.
The violation posed immediate jeopardy through December 7, 2006, the day prior to the
return of the facility van with the new restraint system installed, with staff having been
adequately trained by December 5, 2006. Petitioner has failed to show that the
immediate jeopardy determination was clearly erroneous. The $3050 per day CMP
proposed by CMS is the smallest CMP that is authorized for a deficiency that poses
immediate jeopardy. Accordingly, a CMP of $3050 per day for the period November 14,
2006 through December 7, 2006, is reasonable.

CMS proposed to impose a CMP of $100 per day for the period after immediate jeopardy
was abated but before Petitioner was found to have corrected the violation of 42 C.F.R.

§ 483.25(h)(1) on January 24, 2006. Petitioner alleges that it corrected the violation of
42 C.F.R. § 483.25(h)(1) not later than December 21, 2006, and no remedy should be
imposed for the violation after that date. P. Brief at 13. However, Petitioner’s argument
is not supported by the evidence. Petitioner’s plan of correction included monitoring by
its quality assurance (QA) committee. CMS Ex. 13, at 2. Surveyor Dunn testified that
Petitioner’s Administrator told her that monitoring by the QA committee would not occur
until the committee’s next meeting in January 2007. Tr. 99. Surveyor Dunn testified that
Petitioner was not found to have remedied the violation until the revisit survey on

° Petitioner argues that the $5000 per instance CMP recommended by the state agency
would have been a more appropriate remedy. P. Br. at 14. However, Petitioner has no
right to contest CMS’s choice of remedies and I have no authority to review CMS’s
choice of remedies. 42 C.F.R. §§ 488.408(g)(2); 498.3(d)(11) and (14).
13

January 25, 2007, after monitoring for continued compliance had occurred by Petitioner’s
QA committee. Petitioner has not shown that it effected monitoring as part of its plan of
correction prior to January 25, 2007. Thus, I conclude that Petitioner did not correct the
violation of 42 C.F.R. § 483.25(h)(1) prior to January 24, 2006.

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 non-
compliance, including repeated deficiencies; (2) the facility’s financial condition; (3) the
seriousness of the deficiencies as set forth at 42 C.F.R. § 488.404; and (4) the facility’s
degree of culpability. Emerald Oaks, DAB No. 1800, at 10 (2001); CarePlex of Silver
Spring, DAB No. 1683, at 14-16 (1999); Capitol Hill Community Rehabilitation and
Specialty Care Center, DAB No. 1629 (1997).

CMS proposed a CMP of $100 per day for the period after immediate jeopardy, which is
at the low end of the $50 to $3000 range of penalties authorized for deficiencies that do
not pose immediate jeopardy. 42 C.F.R. § 488.438(a)(ii). Ihave no information
regarding the facility’s history of non-compliance (other than in the survey cycle before
me) and Petitioner has not provided me with information regarding the facility’s financial
condition. The deficiency at issue was a serious one that caused serious injury to
Resident 4. However, by December 8, 2006, Petitioner had taken all necessary steps to
remedy the regulatory violation except demonstrating that it was monitoring to ensure no
recurrence. Considering the facility’s efforts to remedy the violation, I conclude that the
minimum authorized CMP of $50 per day is reasonable after immediate jeopardy was
abated on December 8, 2006.’

T Tnote Petitioner’s argument that CMPs imposed in other cases have been calculated
starting with the date of the survey and ending when the facility came into compliance,
while here the CMP was assessed from the date of the “solitary instance of
noncompliance,” thus leading to the imposition of an excessive CMP in this case. P. Br.
at 15. As noted by the Board, “[c]ase to case comparisons generally have little value
given the unique circumstances of each case and the myriad factors that must be
considered.” Western Care Management Corp., d/b/a Rehab Specialties Inn, DAB No.
1921, at 94 (2004). In this case it was not unreasonable to begin the CMP with the date
of the incident.
14

Il. Conclusion

For the foregoing reasons, I uphold CMS’s determination that Petitioner violated

42 C.F.R. § 483.25(h)(1) on November 14, 2006, and did not return to substantial
compliance with program participation requirements until January 26, 2007. However, I
find that immediate jeopardy existed only from November 14 through December 7, 2006,
and that a CMP of $3050 is only reasonable through December 7, 2006. A CMP of $50
per day is reasonable from December 8, 2006 through January 24, 2007.

/s/
Keith W. Sickendick
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
)
Senior Rehabilitation & Skilled ) Date: May 18, 2009

Nursing Center (CCN: 67-5541), )
)
Petitioner, )
)

-Vv.- ) Docket No. C-08-755

) Decision No. CR1953
Centers for Medicare & Medicaid )
Services. )
)

DECISION

Petitioner, Senior Rehabilitation & Skilled Nursing Center (Petitioner or facility), is a
nursing facility located in Port Arthur, Texas, that participates in the Medicare program.
Based on a complaint investigation/survey completed June 12, 2008, by the Texas
Department of Aging and Disability Services (State Agency), the Centers for Medicare
& Medicaid Services (CMS) determined that, from June 2 through July 15, 2008, the
facility was not in substantial compliance with program participation requirements, and
imposed a civil money penalty (CMP) of $800 per day for each day of substantial
noncompliance (total CMP $35,200). Petitioner appeals, and CMS now moves for
summary judgment.

For the reasons discussed below, I find that summary judgment is appropriate. Based on
undisputed facts, I conclude that the facility was not in substantial compliance with
Medicare requirements governing notification of changes, 42 C.F.R. § 483.10(b)(11), and
prevention of pressure sores, 42 C.F.R. § 483.25(c). I affirm as reasonable the penalties
imposed.

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 June 12, 2008, CMS
determined that the facility was not in substantial compliance with Medicare participation
requirements, specifically:

e 42 C.F.R. § 483.10(b)(11) (Tag F157 — resident rights: notification of changes);

e 42 C.F.R. § 483.25(c) (Tag F314 — quality of care: pressure sores); and

© 42 C.F.R. § 483.25(a)(3) (Tag F312 — quality of care: activities of daily living).

CMS subsequently determined that the facility returned to substantial compliance on July
16, 2008. CMS Exs. 1, 3; P. Exs. 1, 2, 5.

CMS has imposed against the facility a CMP of $800 per day for the period of substantial
noncompliance (44 days x $800 = $35,200).

Petitioner timely requested a hearing. CMS has moved for summary judgment, which
Petitioner opposes. With its motion and brief, CMS has submitted 14 exhibits (CMS Exs.
1-14). With its response, Petitioner has submitted 29 Exhibits (P. Exs. 1-29).

II. Issues

I consider first whether summary judgment is appropriate.

On the merits, the issues before me are: 1) whether, from June 2 through July 15, 2008,
the facility was in substantial compliance with 42 C.F.R. §§ 483.10(b)(11); 483.25(c);

and 483.25(a)(3); and 2) if the facility was not in substantial compliance, was the penalty
imposed, $800 per day, reasonable?
II. Discussion

A, Because the undisputed facts establish that facility staff did not immediately
consult an attending physician when Resident 26 experienced rapid weight loss
nor when the facility’s dietary consultant recommended a change in treatment,
the facility was not in substantial compliance with 42 C.F.R. § 483.10(b)(11),
and CMS is entitled to summary judgment on that issue.

Summary judgment is appropriate if a case presents no genuine issue of material fact and
one party is entitled to judgment as a matter of law. 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. U.S. Dep't. of Health & Human Services, 388 F.3d 168, 173 (6th Cir. 2004)
(quoting Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986)). To avoid summary
judgment, the non-moving party must then act affirmatively by tendering evidence of
specific facts showing that a dispute exists. Matsushita Elec. Indus. Co. v. Zenith Radio
Corp., 475 U.S. 574, 586, n.11 (1986); see also Vandalia Park, DAB No. 1939 (2004);
Lebanon Nursing and Rehabilitation Center, DAB No. 1918 (2004). In examining the
evidence for the purposes of determining the appropriateness of summary judgment, I
must draw all reasonable inferences in the light most favorable to the non-moving party.
Livingston Care Center, 388 F.3d at 172; Guardian Health Care Center, DAB No. 1943,
at 8 (2004). However, drawing 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 conclusions 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.”).

In this case, CMS alleges as undisputed fact — and presents evidence to establish — that
the facility impermissibly delayed consulting a treating physician whose extremely
vulnerable patient lost almost 10% of her body weight in a month. CMS also alleges as
undisputed fact — and presents evidence to establish — that the facility failed to consult the
treating physician about its consulting dietician’s recommendations for treatment
changes. In CMS’s view, the facility’s inaction violated the regulation governing
notification of changes, which mandates that the facility immediately consult a resident’s
physician whenever there is a significant change in the resident’s physical, mental, or
psychosocial status (i.e., a deterioration in health, mental, or psychosocial status in either
life-threatening conditions or clinical complications); or a need to alter treatment
significantly (i.e., a need to discontinue an existing form of treatment due to adverse
consequences or to commence a new form of treatment). 42 C.F.R. § 483.10(b)(11).
Specifically, CMS alleges the following facts:

Resident 26 (R26) was a 72-year-old woman suffering from organic brain syndrome,
dysphagia, hypertension, and convulsions. She had a history of stroke. She had a gastric
feeding tube (g-tube) in place, through which she received all of her nutrition, hydration,
and medications. CMS Ex. 6, at 6, 10, 17. She was at high risk for pressure sores, and,
in April 2008, had a stage IV pressure sore on her coccyx, and another pressure sore on
her right lower back, which was apparently unstageable because it was obscured by
eschar.' CMS Ex. 6, at 6, 11, 21, 39, 40; P. Ex. 12.

Facility staff weighed R26 monthly. Her weight dropped from 93.6 pounds in March
2008, to 84.6 pounds in April 2008. CMS Ex. 6, at 9.” Staff notified the facility’s
consulting dietician of the weight loss. In a dietary progress note dated April 17, 2008,
the dietician noted R26’s significant weight loss, and her pressure sores, and
recommended the following treatment change: increase her nutritional intake and
hydration from “Jevity 1.5 @ 60 ml x 18 [hours]” to “Jevity 1.5 @ 62 ml x 18 [hours].
The consulting dietician reminded staff to turn on the resident’s feeding tube “in a timely
manner,” and recommended that she be weighed weekly, rather than monthly. CMS Ex.
6, at 6-7.

93,

' Pressure sores (also referred to as pressure ulcers or decubitus ulcers) are classified into
stages, based on the extent of the damage to skin and underlying tissues. At stage I, the
skin may appear reddened, like a bruise. Although the integrity of the skin remains
intact, the area is at high risk of further breakdown, so it is crucial that the area be
identified promptly and treated properly. At stage II, the skin breaks open, wears away,
and forms an ulcer. At stage III, the sore worsens and extends beneath the skin surface,
forming a small crater, presenting a high risk of tissue death and infection. By stage IV,
deeper tissues (muscles, tendons, bones) suffer extensive damage, which can cause
serious complications, such as osteomyelitis (infection of the bone) or sepsis (infection
carried through the blood). John L. Zeller, MD, PhD, Pressure Ulcers, 296 J. AM. MED.
ASS’N 1020 (2006), available at www.jama.com (follow link to Past Issues); CMS Ex. 9,
at 4. Eschar is a slough, or piece of dead tissue, like a scab.

> R26’s quarterly assessment, signed April 23, 2008, correctly reports R26’s weight at 85
pounds, but incorrectly and inexplicably denies weight loss of 5% or more in the
preceding 30 days, and denies weight loss of 10% or more in the preceding 180 days.
Compare CMS Ex. 6, at 17, with CMS Ex. 6, at 9. The regulations require that
assessments be accurate. 42 C.F.R. § 483.20. CMS has not cited a deficiency under
section 483.20.

* Jevity is a fiber-fortified, calorically dense, tube-feeding formula. For 18 hours each
day, R26 was supposed to receive 60 milliliters of the formula per hour. The dietician
recommended that the hourly amount be increased to 62 milliliters.
No one told R26’s attending physician about her weight loss or the dietician’s
recommendations until almost three weeks later, on May 7, 2008. CMS Ex. 6, at 8. In
the meantime the dietician’s recommendations were ignored. R26’s care plan was not
amended to address the weight loss problem until May 6, and the new care plan was
obviously developed without regard to the dietician’s recommendations and without
attending physician input (since the physician had not yet been notified of the problem).
CMS Ex. 6, at 36.

Petitioner tenders no evidence showing that a factual dispute exists with respect to its
fulfilling its obligation to consult R26’s attending physician about her weight loss and the
dietician’s recommendations. In fact, Petitioner’s evidence confirms CMS’s factual
assertions. Petitioner submits an affidavit from Dr. William George, R26’s attending
physician, who confirms that on May 7, 2008, the facility “apprised” him of R26’s weight
loss and of the dietician’s April 17 report and recommendation. P. Ex. 28 (George
Decl.).

Dr. George opines, and Petitioner argues, that the facility “appropriately communicated”
and “reasonably and timely informed” him about R26’s care needs and changes in
condition. P. Brief (Br.) at 7; P. Ex. 28 (George Decl.).* These are conclusions that I
need not accept for purposes of summary judgment. See Guardian Health Care Center,
DAB No. 1943, at 11. And, to the contrary, the only reasonable conclusion to be drawn
from the undisputed fact that facility staff delayed three weeks in notifying Dr. George is
that the facility did not meet the regulatory requirement. A three-week delay is simply
unacceptable, particularly when the resident involved is as compromised as R26.
“Immediately” means “‘as soon as the change . . . is detected, without any intervening
interval of time.” Magnolia Estates Skilled Care, DAB No. 2228, at 8 (2009); The
Laurels at Forest Glenn, DAB No. 2182, at 13 (2008).

Further, Petitioner does not allege that it did anything other than “communicate” or
“inform” Dr. George. Simply communicating the information does not satisfy the
regulatory requirement to “consult” the treating physician. As the Departmental Appeals
Board ruled in Magnolia Estates, consultation requires more than just informing or
notifying the physician.

Consultation . . . requires a dialogue with and a responsive directive from
the resident’s physician as to what actions are needed; it is not enough to
merely notify the physician of the resident’s change in condition. Nor is it
enough to leave just a message for the physician.

DAB No. 2228, at 9.

+ Petitioner does not argue that the changes in R26’s condition were not “significant,” as
indeed they were. See The Laurels at Forest Glenn, DAB No. 2182, at 11-12.
The undisputed facts establish that the facility am

ended R26’s care plan to address the

weight loss without physician consultation and without regard to the dietician’s
recommendations, which may explain why the revised plan does not seem to address the
needs of a resident who receives nutrition through a g-tube.> Some of its instructions are

general: “supervise and maintain residents [sic] safety and well being
and encourage family to participate in plan of care
and follow physicians [sic] orders.” Other

ption” and “offer supplemental nutrition if resident

abnormalities or difficulties observe

instructions — “monitor meal consum,
consumes less than 50% of meal” — p!
meals, not to R26, who received all o
over her meal consumption. Ironical
notifying the physician of abnormalities) were “o
“assess for need to change dietary consistency.”

lainly apply

Petitioner does not explain who decided or how t
the treatment changes recommended by the healt!
expertise in nutrition, but justifies its disregard o

; “notify family
notify family and physician of

>

to an individual who is able to eat her

f her nutrition through a g-tube and had no control
ly, the most relevant provisions of the plan (besides

btain dietary consult if needed” and

CMS Ex. 6, at 36.

at person or persons decided to reject

h care professional with special

the dietician’s recommendations by

arguing that R26 “was already receiving more than adequate nutrition to meet her daily

needs without the recommended increase of 2 m
29, at 2 (Banks Decl. ¥5).° I accept t
judgment, but I do not find them material. R26’s
interdisciplinary team charged with planning her

of feeding per hour.” P. Br. at 8; P. Ex.

hese assertions as true for purposes of summary

physician (along with the
care) might well have had sound reasons

for rejecting the dietician’s recommendations. H
attending
presented
George ul

timately concurred (at least temporari

* The facility must develop

owever, failing to consult R26’s
physician about her dramatic weight loss risked her health and safety and

the potential for more than minimal harm. Further, while fortuitous that Dr.

ly)’ with the actions (or inaction) taken by

‘or each resident an individualized comprehensive care plan

describing services that are to be furnished to attain or maintain the resident’s highest

practicable physical, mental,
an interdisciplinary team tha
other appropriate staff (whic

and psychosocial well-being. The plan must be prepared by
t includes the attending physician, a registered nurse, and
could include a dietician). 42 C.F.R. § 483.20(k). CMS

has not cited a deficiency under the care planning regulation. But see CMS Ex. 12, at 6
(McElroy Decl. § 6) (in which CMS nurse consultant Daniel McElroy, R.N., points to
need for “consultation with her physician for more nutrition and revision of her nutrition

care’).

° But see CMS Ex. 6, at 47, 49 (Even before her dramatic weight loss, R26’s care plan
directs staff to “improve nutrition,” an instruction that was ignored, and, based on

Petitioner’s assertions here, erroneous.).

7 A physician’s order dated June 2, 2008, increases feeding to “62 cc/hr per dietary

recommendation.” CMS Ex. 6, at 62.
facility staff without his knowledge or approval, staff plays a dangerous game when it
rejects an expert’s recommendation without input from the attending physician. I find
that such action poses a risk to resident health and safety and presents the potential for
more than minimal harm.

The undisputed facts thus establish that the facility did not immediately consult the
resident’s attending physician following a significant change in her condition, and the
facility was therefore not in substantial noncompliance with 42 C.F.R. § 483.10(b)(11).
CMS is entitled to summary judgment on that issue.

B. The uncontroverted evidence establishes that staff did not consistently follow
care plan instructions and that staff allowed a vulnerable resident to lie for up to
two hours on a urine and feces contaminated incontinent pad. The facility was
therefore not taking all necessary precautions to promote healing, prevent
infection, and prevent new pressure sores from developing, as required by 42
CF.R. § 483.25(c), and CMS is entitled to summary judgment on that issue.

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

§ 1819(b); 42 C.F.R. § 483.25. The regulation further requires that the facility ensure,
based on the resident’s comprehensive assessment, that a resident who enters the facility
without pressure sores does not develop them unless his/her clinical condition shows that
they were unavoidable. 42 C.F.R. § 483.25(c)(1). Ifthe resident has pressure sores, the
facility must ensure that he/she receives the treatment and services necessary to promote
healing, prevent infection, and prevent new sores from developing. 42 C.F.R.

§ 483.25(c)(2). In assessing the facility’s compliance with this requirement, the relevant
question is: did the facility “take all necessary precautions” to prevent new sores from
developing. If they did so and the resident develops sores anyway, I could find no
deficiency. But if the evidence establishes that the facility fell short of taking all
necessary precautions, then the regulation is violated. Koester Pavilion, DAB 1750, at 32
(2000).

The prevention or healing of pressure ulcers requires scrupulous and
continuous attention to minimizing compression and shearing pressures,
avoiding maceration from continuous moisture and contact with the skin-
erosive contents of urine, feces and bacteria while maximizing blood flow,
hydration and nutrition.

CMS Ex. 12, at 4 (McElroy Decl. § 6).
CMS’s allegations of noncompliance with section 483.25(c) center around the care
provided to R26 and two other residents, R100 and R92. Because the deficiencies in the
care provided to R26, by themselves, justify the penalties imposed, I do not address the
citations relating to the other two residents. See Batavia Nursing and Convalescent
Center, DAB No. 1904, at 23 (2004); Beechwood Sanitarium, DAB No. 1824, at 19
(2002) (within the ALJ’s discretion to limit his decision to findings necessary to support
the remedies imposed).*

As discussed above, R26 was assessed at high risk for pressure sores. CMS Ex. 6, at 21,
31; P. Ex. 12. When re-admitted to the facility in January 2008, she had pressure sores
on her coccyx and left inner knee. Among other approaches, her care plan, which was
originally dated January 24, 2008, with the date changed monthly thereafter, called for an
indwelling catheter “to promote wound healing [due to] unstageable decub[itus] to
coccyx.” CMS Ex. 6, at 31, 32; P. Ex. 13, at 3.

The ulcer on R26’s coccyx did not heal, and, over time, she developed additional sores.
By April, she had developed a “nonstageable” (defined as “full thickness tissue loss in
which the base of the ulcer is covered by slough . . . and/or eschar . . . in the wound bed”)
pressure sore on her right lower back. CMS Ex. 6, at 48, 49, 52. That wound did not
heal either. At the time of the June survey, R26 also had stage II pressure sores on her
left and right hips (CMS Ex. 6, at 43, 58; CMS Ex. 13, at 2), a stage II pressure sore on
her left elbow (CMS Ex. 6, at 44; CMS Ex. 13, at 2), and a stage I pressure sore on her
left lateral foot (CMS Ex. 6, at 45).

In his declaration, Dr. George opines that “the development of [R26’s] skin wounds
located on her feet, left elbow, hips and coccyx were medically unavoidable due to her
compromised circulation and other underlying diseases.” P. Ex. 28 (George Decl.).? For
purposes of summary judgment, I accept that R26’s pressure sores were clinically
unavoidable. However, this fact does not relieve the facility of its obligation, under the
regulation, to provide care and services necessary to promote healing, prevent infection,
and prevent other pressure sores from forming.

Citing testimony from Lisa Jackson, R.N., the facility’s quality assurance nurse,
Petitioner also asserts that staff conducted risk assessments, completed care plans which
set forth goals and interventions, and then monitored the wounds to determine the plans’
effectiveness. P. Br. at 10, 11; P. Ex. 27, at 3 (Jackson Decl. 47). CMS does not dispute
the existence of some assessments and care plans, and I accept that the facility developed

* For the same reason, I decline to address the deficiencies cited under 42 C.F.R.
§ 483.25(a)(3).

° Dr. George does not include in this list the pressure sore on R26’s right lower back. I
assume the omission was simply an oversight.
multiple care plans to address R26’s susceptibility to pressure sores. CMS criticizes the
quality of the assessments and plans. As the discussion below establishes, facility
assessments and care plans were often incomplete, and occasionally inconsistent, but, for
purposes of summary judgment, I accept that they were adequate. But see CMS Ex. 12,
at 4 (McElroy Decl. § 6) (minimum assessment includes staging, measurement of size,
exudate, wound bed characteristics, pain, surrounding skin and tunnel/sinus tract
ormation). Nevertheless, undisputed evidence establishes that the facility was not in
substantial compliance because its staff did not consistently follow the instructions in
those plans.

January 2008 assessments and plans. In addition to calling for an indwelling catheter,
R26’s January 24, 2008 plan directs staff to: provide incontinent care every two hours
and as needed; insure that the resident is turned and repositioned every two hours and as
needed; reinforce proper positioning with pillows if necessary; conduct ongoing
assessment of skin for signs and symptoms of redness or breakdown; and notify the
attending physician as necessary. The plan sets as a goal that the “res[ident] will not
ave skin breakdown x 90 days.” CMS Ex. 6, at 31.

Specifically addressing her then-existing ulcers, the plan also sets as a goal that R26’s
“ulcer will be free of drainage and show signs of healing x 90 days” (i.e., by late April
2008). Approaches listed are: administer treatment as ordered by the attending
physician; maintain good infection control when dealing with ulcers; monitor for
drainage, odor; encourage good dietary intake to promote wound healing;'° monitor labs
as ordered; resident to be out of bed daily as tolerated; turn and reposition resident every
two hours and as needed; and notify the attending physician as indicated. CMS Ex. 6, at
32.

Finally, the care plan notes that R26 is incontinent of bowel, and does not voice the urge
to have a bowel movement because she no longer talks. It sets as a goal that she “will
remain clean and odor free for the next 90 days.” Approaches listed are: closely
supervise to maintain resident safety and well being; encourage family to participate in
plan of care; answer resident’s summons to room promptly; check resident frequently for
incontinence and provide incontinent care as needed; frequently assess skin for signs and
symptoms of breakdown or injury and treat according to physician orders; maintain
resident’s dignity and explain what you are going to do; and provide incontinent care
every two hours and as needed. CMS Ex. 6, at 35.

April 2008 assessments and plans. The January care plans did not achieve their stated
goals — no skin breakdown; drainage-free with signs of healing — because, by April 2008,
R26’s coccyx ulcer had deteriorated, and she had developed a new pressure ulcer on her

© Again, since R26 was wholly dependent on a g-tube for her nutrition, the instruction
that staff “encourage good dietary intake” does not seem relevant to her.
10

lower right back. A care plan, dated April 4, 2008, identifies as a problem “pressure
ulcer(s) right lower back.” The goals set are: that the pressure ulcer show signs of
healing and that pressure ulcer risk will be minimized, with a target date of July 4, 2008.
The approaches are listed as reposition every two hours, treat with Accuzyme, assess
wound daily, and notify MD/RP of any change in status. CMS Ex. 6, at 40.

With respect to the ulcer on R26’s coccyx, the record contains no corresponding
assessment, but a care plan, dated April 11, 2008, sets as goals, that the pressure ulcer
show signs of healing and that pressure ulcer risk will be minimized, with a target date of
July 11, 2008. The approaches listed are: reposition (although the space for indicating
frequency for repositioning is left blank); treat with Sorbsan; “assess wound daily”; and
“notify MD/RP of any change in status.” CMS Ex. 6, at 39 (emphasis added).

Both wounds were re-assessed on April 17, 2008. An April 17 assessment worksheet
describes the wound on R26’s right lower back as yellow, brown and black, and “not
stageable.” It measures 1.9 cm long, 2.0 cm wide. It has eschar/slough and scant serous
drainage. CMS Ex. 6, at 48. The assessment characterizes the wound as “acute non-
surgical (duration less than 6 wks).” Treatment goals are underlined on the form:
pressure redistribution, control bioburden, improve nutrition, |! promote circulation, and
promote granulation/contraction/re-ephithelialization. CMS Ex. 6, at 49.

An April 17 wound assessment describes the coccyx wound as a red/pink stage III
wound, 9 cm long, 8.5 cm wide, and 0.4 cm deep, with moderate serosang (blood and
serum) drainage, without odor, eschar, undermining or tunneling. CMS Ex. 6, at 46.
According to the assessment, the wound is “chronic” but “improving.” The treatment
goals underlined are the same treatment goals as for the right lower back wound. CMS
Ex. 6, at 47.

Additional assessments are dated April 25. The right lower back wound is larger than
before, 5.6 cm long by 2.5 cm wide, and the treatment goals are the same with the
addition of “decrease or remove necrotic tissue.” CMS Ex. 6, at 52-53. The coccyx
wound assessment describes that wound as a red and pink stage III pressure sore,
measuring 7.5 cm long, 7.5 cm wide and 0.4 cm deep with moderate serosang drainage.
CMS Ex. 6, at 50. The earlier treatment goals are repeated, with the addition of
“decrease or remove necrotic tissue.” CMS Ex. 6, at 51.

May 2008 assessments and plans. A May 2 assessment measures the right lower back
wound at 5.2 cm long, 3.0 cm wide, and describes it as yellow and black. CMS Ex. 6, at
54. The treatment goals remain the same except that the goal to “decrease or remove

" Thus, according to the care plan, R26’s nutrition needed improvement, a fact that is at
odds with Petitioner’s articulated position, discussed above, that no changes in nutrition
were necessary.
11

necrotic tissue” has not been underlined. CMS Ex. 6, at 55; see CMS Ex. 11, at3. A
document dated May 2, labeled “weekly skin report,” which lists pressure ulcers, records
the size of the coccyx wound as 6.0 x 7.8 x 0.4. CMS Ex. 11, at 3.

Petitioner submits a virtually unreadable copy of a May 5 assessment of R26’s lower
back wound. P. Ex. 15, at 1. A second May 5 assessment describes the coccyx wound as
at stage III, with moderate serosang drainage. The wound depth is 0.3 cm deep, but the
length and width are not decipherable on the copy submitted. P. Ex. 15, at 5. A final
May 5 assessment describes a right hip wound as red and pink, measuring 2.9 x 3.4,
without drainage. The assessment does not stage the wound. P. Ex. 15, at 9.

The May 16 weekly skin report says the pressure ulcer on R26’s right lower back is 3.5 x
5.3 x 0, and the coccyx ulcer is 6.2 x 8.5 x 0.3. CMS Ex. 11, at 9. It does not mention a
hip wound.

An assessment dated May 16 of R26’s lower back wound is also difficult to read, but
seems to indicate that the wound is unstageable and has scant serous drainage. Its
measurements are not decipherable. P. Ex. 15, at 2. The coccyx wound assessment,
dated May 16, puts the wound at stage IV, measuring 6.5 x (an unreadable width) x 0.3.
P. Ex. 15, at 6.

The May 23 skin report lists the dimensions for the lower back ulcer as 3.5 x 5.3 x 0, and
describes the coccyx ulcer at 5.4 x 8.5 x 0.3. CMS Ex. 11, at 12.

Petitioner submits additional assessments, apparently dated May 22 and May 29,
although the dates are difficult to read. P. Ex. 9. On May 22, the coccyx wound was
assessed at stage IV and measured 5.4 x 8.5. It was red, with a small amount of serosang
drainage. P. Ex. 9, at 1; P. Ex. 15, at 7. The lower back wound was not stageable. It
measured at 5.4 x 2.9 and was red and yellow with a small amount of serosang drainage.
P. Ex. 9, at 3. For May 29, the coccyx wound assessment does not indicate a stage, but
says that the wound measures 5.7 x 7.7 with moderate serosang drainage. P. Ex. 9, at 2;
P. Ex. 15, at 8. The lower back wound is assessed as unstageable and measures 5.0 x 3.4
with a small amount of serosang drainage. P. Ex. 9, at 4; P. Ex. 15, at 4. Petitioner also
submits a May 29 assessment of the wound on R26’s right hip, which describes the
wound as pink, measuring 3.1 x 4.0, with scant serosang drainage. No staging
information is provided. P. Ex. 9, at 5; P. Ex. 15, at 10.

June 2008 assessments and plans. According to CMS, R26 had additional wounds that
were neither identified nor properly assessed until pointed out by one of the surveyors. In
her written declaration, Surveyor Deena Gill, R.N., asserts that on June 2, she found R26
with unreported pressure sores on her feet, her left elbow, and both hips. CMS Ex. 13, at
2 (Gill Decl.). Petitioner does not exactly deny the assertion, but offers Nurse Jackson’s
declaration that “there would have not been weekly skin assessments for the areas on the
elbow, the left hip and the feet since these areas were new.” P. Ex. 27, at 2 (Jackson

12

Decl. 4 4). R26’s care plan is ambiguous about how frequently staff were supposed to
perform skin checks, calling for “ongoing assessment of skin,” and instructing staff to
“frequently assess skin.” CMS Ex. 6, at 31, 35. Drawing every inference in the light
most favorable to the non-moving party, I allow that a weekly skin assessment could be
consistent with R26’s care plan for skin assessments, and I accept as true the prospect
that not one of the four additional wounds listed by Nurse Jackson was detectable on or
before May 23, the date of the last weekly skin assessment prior to the surveyor
observations on June 2.

But Nurse Jackson does not mention the right hip wound, which was first described in an
assessment dated May 5. P. Ex. 15, at 9. That wound was apparently not assessed
weekly, since it is not mentioned again until the May 29 assessment. P. Ex. 9, at 5; P. Ex.
15, at 10. Further, a weekly skin report, dated June 6, 2008, lists a “right hip abrasion”
measuring 3.1 x 4.0 x 0.1, along with sores on her coccyx and right back, and says that
the hip sore was found on April 28. CMS Ex. 11, at 14. Nevertheless, the hip sore was
not mentioned in the earlier weekly reports of May 2, May 9, May 16, and May 23,
which suggests that staff were not adequately conducting weekly skin assessments in
accordance with R16’s care plan. CMS Ex. 11, at 3, 6, 9, 12.

More significant, however, R26’s care plan also required that staff assess daily the
pressure sores on her lower back and coccyx. CMS Ex. 6, at 39, 40. Petitioner presents
no evidence — indeed does not claim — that staff followed the care plans in this regard.
See P. Br. at 9; P. Ex. 29, at 3-4 (Banks Decl. § 7) (“weekly skin assessments were
conducted and acted upon.”). The undisputed evidence establishes that the facility was
not taking all necessary precautions to prevent pressure sores because staff plainly did not
follow R26’s care plan instructions to assess those wounds daily.

With respect to the dangers posed by R26’s incontinence, her care plans call for an
indwelling catheter and instructs staff to provide incontinent care every two hours and as
needed. CMS Ex. 6, at 31, 35. Staff are also instructed to “check resident frequently for
incontinence and provide incontinant [sic] care as needed” and to “maintain good
infection control when dealing with ulcers.” CMS Ex. 6, at 32, 35 (emphasis added).

Surveyor Gill testified that on June 2 she observed R26 lying on a wet incontinent pad
with drying feces on her buttocks. CMS Ex. 13, at 3 (Gill Decl.); accord CMS Ex. 3, at
12 (R26 observed on wet incontinent pad with drying brown edges); CMS Ex. 4, at 1
(“smells like urine”; “cold wet BM on buttocks”). Petitioner does not dispute the
surveyor observation, but argues that, so long as staff provided incontinent care every
two hours, it complied with facility protocols and sound nursing practice. According to
Director of Nursing, Dana Banks, R.N.:

The surveyors state Resident 26 was laying [sic] on an incontinent pad that
had a drying brown ring and foul urine odor, and Resident 131 had a wet
13

incontinent pad with drying feces. These circumstances do not necessarily
indicate the facility failed to provide incontinent care within a two hour
period. The words “drying” and “wet” used to describe the urine, feces and
brown ring indicates [sic] the bowel movements or urine could have just as
easily been a recent occurrence (i.e. less than two hours old).

P. Ex. 29, at 3 (Banks Decl. § 6); see P. Br. at 8.

Thus, in Petitioner’s view, the facility may allow a resident, even someone as
compromised as R26, to lie in urine and feces for up to two hours at a time without
running afoul of the requirement that it take all necessary precautions to promote healing,
prevent infection, and prevent new sores from developing. I disagree.

Petitioner has not explained how R26 ended up on a wet incontinent pad in the first place.
An indwelling catheter was in place to prevent that from happening. CMS Ex. 6, at 16
(indwelling catheter in place “that does not leak urine”). R26’s care planners recognized
that such a catheter put her at significant risk of infection, but determined that the dangers
posed by exposing her skin to urine outweighed the considerable danger of a urinary tract
infection (UTI). CMS Ex. 6, at 31; see CMS Ex. 6, at 32, 38 (“decline since hospital stay
with UTI”). Facility policy required that staff “[m]ake sure that there is no disconnection
or leaking of urine from the [catheter] system (except into the drainage bag).” CMS Ex.
9, at 7 (emphasis added). But staff obviously did not do so. As a result, R26 suffered the
significant risk of a UTI, without deriving the anticipated benefit of clean, dry skin.

Moreover, R26 could not safely be exposed to urine and/or feces for any significant
period of time, and neither facility policy nor her care plan allowed for such ongoing
exposure. Facility policy instructed staff to “[c]lean skin as soon as soiled.” CMS Ex. 9,
at 2. Although both the facility’s written policy and R26’s care plans instructed staff to
check the incontinent resident at least once every two hours, they also consistently said
that she should be checked “frequently,” provided care “as needed,” and that staff should
maintain “good infection control when dealing with ulcers.” CMS Ex. 6, at 31, 32, 35;
CMS Ex. 9, at 8.

Pressure ulcers are made worse by moisture, and by irritating substances, such as feces
and urine, on the resident’s skin. CMS Ex. 9, at 1. Stage III and stage IV pressure ulcers
are further damaged by contact with acidic urine and the enzymes in feces. Bacteria from
feces can readily infect the wounds. CMS Ex. 12, at 4 (McElroy Decl. J 6). R26 hada
pressure sore on her coccyx the size of a soft ball, and that sore was “tunneling.” CMS
Ex, 3, at 12; CMS Ex. 6, at 56.'* She was at high risk for infection. Far from “providing

” Staff did not notify Dr. George of the tunnels — the crater beneath the skin surface,
which creates a high risk of tissue death and infection — until June 2, the first day of the
survey. CMS Ex. 6, at 12.

14

treatment and services necessary to promote healing, prevent infection, and prevent new
sores from developing,” the facility’s allowing R26 to lie in urine and feces for up to two
hours at a time significantly increased her risk of infection and developing new sores.
The facility was therefore not in substantial compliance with 42 C.F.R. § 483.25(c).

C. The penalties imposed are reasonable.

I next consider whether the CMP is 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.

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 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 seg. (2002); Emerald Oaks, DAB No. 1800, at 9-10
(2001); CarePlex of Silver Spring, DAB No. 1683, at 8 (1999).

CMS has imposed a penalty of $800 per day for the period of substantial noncompliance,
which is at the low end of the penalty range ($50-$3000). 42 C.F.R. § 488.438(a)(1).

With respect to the facility history, CMS Nurse Consultant, Captain (Ret.) Daniel J.
McElroy R.N. characterizes this as the facility’s “sixth noncompliance cycle,” and the
first enforcement action since April 2005. He points out that, during an April 30, 2008
survey, surveyors also found a pattern of noncompliance with 42 C.F.R. § 483.10(b)(11)
that caused no actual harm, but with the potential for more than minimal harm. CMS Ex.

12, at 7 (McElroy Decl. § 7); CMS Ex. 1. Petitioner does not challenge his assertion.
Petitioner has not argued that its financial condition affects its ability to pay the penalty.

With respect to the remaining factors, R26 was an extremely vulnerable resident at high
risk for pressure sores. But facility staff did not keep her clean and dry; they did not
insure that her catheter was free of leaks; and they allowed her to lie on a wet and soiled
incontinent pad for up to two hours at a time. They did not assess daily her significant
and deteriorating pressure sores as called for in her care plan. Notwithstanding the
15

importance of nutrition and hydration in preventing and treating pressure sores, staff
waited three weeks before they even advised her attending physician of a dramatic and
problematic weight loss. And, without consulting that physician, they completely
disregarded the dietician’s recommendations for changes in her treatment. Staff thus
showed disregard for her care, comfort, and safety, for which they are culpable. Facility
culpability, together with its less than stellar history, justifies the penalties imposed.'*

IV. Conclusion

For the reasons discussed above, I find that, from June 2 through July 15, 2008, the
facility was not in substantial compliance with Medicare requirements governing
notification of changes (42 C.F.R. § 483.10(b)(11)) and quality of care — prevention of
pressure sores (42 C.F.R. § 483.25(c)). L affirm as reasonable the $800 per day CMP
(total $35,200).

/s/
Carolyn Cozad Hughes
Administrative Law Judge

© Petitioner also challenges CMS’s determination that its deficiencies constituted
substandard quality of care, 42 C.F.R. § 488.301. I decline to review that issue since my
finding would not affect the facility’s loss of nurse aide training. 42 C.F.R.

§ 498.3(b)(16) (substandard quality of care finding reviewable only if it leads to facility’s
loss of approval of its nurse aide training program). Since the penalty imposed is greater
than $5000, the Act precludes approval of the facility’s nurse aide training program
without regard to the finding of substandard quality of care. Act § 1819(f)(2)(B).


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

In the Case of: )
)
Comfort Home Health Care, Inc., ) Date: May 18, 2009

(CCN: 15-7567), )
)
Petitioner, )
)

-Vv.- ) Docket No. C-09-177

) Decision No. CR1952
Centers for Medicare & Medicaid )
Services. )
)

DECISION

The September 3, 2008 request for hearing filed by Comfort Home Health Care, Inc.,
Petitioner, is dismissed pursuant to 42 C.F.R. § 498.70(c) because it was not timely filed.
Furthermore, Petitioner has not shown good cause for an extension of time to file the
request for hearing.

I. Background

Petitioner is a home health agency doing business in the State of Indiana. It participated
in the Medicare program and its participation was governed by provisions of the Social
Security Act (Act) and by implementing regulations. Its hearing rights in this case are
governed by regulations at 42 C.F.R. Part 498.

This matter is before me based on Petitioner’s request for review of Centers for Medicare
& Medicaid Services’ (CMS) determination to terminate its Medicare provider agreement
based on findings made at a recertification survey of Petitioner’s agency completed on
June 9, 2008 (June survey), by the Indiana State Department of Health (state survey
agency). CMS Exhibit (Ex.) 1; CMS Ex. 3, at 1-2. On June 20, 2008, CMS notified
Petitioner (June notice) that it was terminating its Medicare provider agreement effective
September 5, 2008, unless Petitioner was in compliance with participation requirements
by that date. CMS Ex. 3, at 1-3. The June notice also advised Petitioner that it could
submit a plan of correction (POC) to address the deficiencies identified at the June survey.
The June notice advised Petitioner that the POC would be reviewed upon receipt and, if
CMS found it to be acceptable, CMS would ask the state survey agency to conduct a
revisit survey of Petitioner’s agency in order to verify compliance. CMS Ex. 3, at 2. The
2

June notice also advised Petitioner that it had a right to request a hearing before an
administrative law judge (ALJ) of the Departmental Appeals Board if it wished to contest
CMS’s determination. In advising Petitioner of that right, the notice stated:

If you desire a hearing, you must request it not later than 60 days from
the date you receive this notice.

CMS Ex. 3, at 3.

Petitioner filed a POC on August 7, 2008, for the deficiencies cited in the June survey.
CMS Ex. 1. A revisit survey of Petitioner’s agency was completed on August 28, 2008
(August revisit), in order to ascertain whether Petitioner had attained compliance with
participation requirements. CMS Ex. 4, at 1. Based on the outcome of the August
revisit, CMS determined that Petitioner remained out of compliance. Therefore, CMS
effectuated termination of Petitioner’s Medicare participation on September 24, 2008.
CMS Ex. 7. CMS notified Petitioner of its determination to terminate the provider
agreement by notice dated September 4, 2008 (September notice). CMS Ex. 7, at 2. The
September notice further advised Petitioner that CMS was “administratively extending
the termination date to September 24, 2008 to allow sufficient time to publish legal notice
of the termination.” CMS Ex. 7, at 3. The September notice informed Petitioner that it
could submit a POC, and further advised:

If you believe that this determination is not correct, you may request a
hearing before an Administrative Law Judge of the Department of
Health and Human Services, Departmental Appeals Board. If you desire
a hearing, you must request it not later than 60 days from the date you
receive this notice.

CMS Ex. 7, at 3.

Petitioner subsequently filed a request for hearing on September 3, 2008. However,
Petitioner’s request for hearing references and contests only the June notice from CMS.
CMS Ex. 6. Petitioner did not file a request for hearing to contest the findings of the
revisit survey completed on August 28, 2008.

The case was assigned to me on January 8, 2009 for hearing and decision. On March 6,
2009, CMS filed a motion to dismiss the request for hearing (CMS Br.) on the ground
that it was not timely filed. In support of its motion, CMS filed 11 exhibits marked as
CMS Exs. 1-11. Petitioner responded to CMS’s motion on March 17, 2009 (P. Br.), but
did not file any proposed exhibits with its brief. Petitioner did not object to the exhibits
offered by CMS. Accordingly, I admit CMS Exs. 1-11 into evidence.
IL. Discussion
A. Findings of Fact

1. By letter dated June 20, 2008, CMS notified Petitioner that it was
terminating its Medicare provider agreement effective September 5, 2008,
based on the deficiencies cited during a June 9, 2008 survey. CMS Ex. 3.

2. On August 7, 2008, Petitioner submitted a POC for the deficiencies cited
during the June 9, 2008 survey. CMS Ex. 1.

3. Petitioner filed its request for a hearing by an ALJ on September 3, 2008,
appealing the deficiencies cited during the June 9, 2008 survey. CMS Ex. 6.

4. By letter dated September 4, 2008, CMS notified Petitioner of the findings
of an August 28, 2008 revisit survey that disclosed Petitioner remained out of
substantial compliance with participation requirements. CMS informed
Petitioner that it would be terminated from participation in the Medicare
program. Petitioner was further informed that CMS was extending the
termination date of its Medicare provider agreement from September 5 to
September 24, 2008 in order to meet the regulatory requirements for public
notice. CMS Ex. 7.

5. Petitioner received CMS’s September 4, 2008 notice on September 8, 2008.
CMS Ex. 8, at 1, 4.

6. On September 17, 2008, Petitioner submitted a POC in response to the
revisit survey of its agency completed on August 28, 2008. CMS Ex. 8.

7. On October 8, 2008, Petitioner wrote to CMS requesting a response to its
September 17, 2008 POC submission and that it be resurveyed. CMS Ex. 9.

B. Conclusions of Law
1. Petitioner’s request for a hearing, dated September 3, 2008 and contesting
CMS’s June 20, 2008 notice, was filed more than 60 days after Petitioner is

presumed to have received the notice.

2. Petitioner’s September 17, 2008 letter to CMS does not constitute a request
for hearing.

3. Petitioner has not shown good cause to extend the time to file a request for
hearing in this case.
4

4. Dismissal of a request for hearing that is not timely filed and for which no
extension of time to file has been granted is appropriate.

III. Issues
The issues in this case are:
1. Whether Petitioner filed a timely request for hearing and, if not;

2. Whether Petitioner has demonstrated good cause for the untimely filing
and should be granted an extension.

IV. Applicable Law

In order to participate in the Medicare program, a home health care agency must execute
a “provider agreement” and undergo surveys to certify its compliance with program
requirements. 42 C.F.R. §§ 488.20; 489.11. The provider agreement contains assurances
that the provider! meets, and will continue to meet, applicable conditions for Medicare
participation, and also reflects CMS’s acceptance of the provider’s eligibility to
participate in the program. 42 C.F.R. §§ 489.11(a); 489.20.

A provider agreement may be terminated by either the provider or by CMS. Section
1866(b) of the Act sets out the conditions under which the Secretary of Health and
Human Services (Secretary) may terminate a provider agreement. Section 1866(b)(2)(B)
provides that the Secretary may, “upon such reasonable notice to the provider and to the
public as may be specified in regulations,” terminate the provider agreement if she
determines that the provider “fails substantially to meet the applicable provisions of
section 1861.” Title 42 C.F.R. § 489.53 implements the statutory provisions governing
termination of a provider, and 42 C.F.R. § 489.53(a)(1) provides that CMS may terminate
a provider agreement if it finds that the provider “is not complying with the provisions of
title XVIII and the applicable regulations or the provisions of the agreement.” Title 42
C.F.R. § 489.53(d)(1) requires that CMS give the provider notice of termination at least
15 days before the effective date of termination. Title 42 C.F.R. § 489.53(e) states that a
provider may appeal the termination of its provider agreement by CMS in accordance
with 42 C.F.R. Part 498.

Pursuant to 42 C.F.R. 498.40(a)(2), a provider must file a request for an ALJ hearing
within 60 days of receipt of the notice of initial, reconsidered, or revised determinations,
unless the period for filing is extended by the ALJ for good cause shown in accordance

' The term “provider” is defined in the regulations to include home health agencies and
other health care organizations. 42 C.F.R. § 400.202.
5

with 42 C.F.R. § 498.40(c)(2). Pursuant to 42 C.F.R. § 498.40(a)(2), which incorporates
by reference 42 C.F.R. § 498.22(b)(3), the provider is presumed to have received the
notice five days after the date on the notice, unless there is a showing that it was, in fact,
received by the provider earlier or later.

A, Petitioner failed to file a timely request for hearing to appeal the findings of
the June 9, 2008 survey.

The June 20, 2008 CMS letter is a notice of initial determination by CMS that it would
terminate Petitioner’s provider agreement because Petitioner was not in substantial
compliance with program participation requirements. CMS Ex. 3. The June notice
clearly advised Petitioner that the deadline for filing a hearing request was not more than
60 days from receipt of the notice. CMS Ex. 3.

Petitioner is presumed to have received the June 20, 2008 notice five days after the date
on the notice pursuant to 42 C.F.R. §§ 498.40(a)(2) and 498.22(b)(3). Petitioner does not
argue and has not demonstrated that the notice was received on a date later than the
presumed receipt date. Here, the fifth day after the date on the notice was Wednesday,
June 25, 2008. The 60" day following June 25, 2008 was Sunday, August 24, 2008.
Petitioner’s request for hearing is dated September 3, 2008, ten days after the 60" day
from the presumed receipt of the notice.

A provider’s failure to file a request for hearing within the regulatory time period, absent
a showing of good cause for such failure, is grounds for dismissal pursuant to 42 C.F.R.

§ 498.70(c). Ihave authority to dismiss Petitioner’s request for hearing in this case
because Petitioner filed its request for hearing 10 days beyond the 60 day period provided
by the regulations. Petitioner does not dispute that it received the June 20, 2008 notice
nor does it present any real arguments relative to this point in its response. Petitioner’s
response brief is essentially a three-page chronology of the facts of the case. Based on
my review of the entire record in this case I find that Petitioner’s request for hearing was
not timely filed within the meaning of the regulatory requirement at 42 C.F.R. §
498.40(a)(2), which incorporates by reference 42 C.F.R. § 498.22(b)(3).

B. Petitioner has not made a showing of good cause for its failure to file a

hearing request in compliance with the regulatory requirement at 42 C.F.R.
§ 498.40(c)(2).

Applicable regulations afford an ALJ authority to extend a party’s deadline for filing its
request for hearing. The authority to extend the time to file a request for hearing is
contingent upon a party establishing that good cause exists for it failure to file a timely
request for hearing. 42 C.F.R. § 498.40(c)(2). The term “good cause,” although not
defined in the regulations, has been the subject of much litigation and is interpreted
6

universally to mean a circumstance beyond a party’s ability to control which prevents
that party from filing its request timely. Hospicio San Martin, DAB No. 1554 (1996).

Petitioner has not denied that it was provided notice by CMS of CMS’s intent to
terminate its provider agreement, nor has Petitioner asserted that it was unaware of the
regulatory requirements governing hearing requests. Petitioner is represented by counsel
who is either aware of, or should be aware of, the timeliness requirements of 42 C.F.R.

§ 498.40(a)(2). Petitioner has offered no satisfactory explanation for its delay in the face
of the regulatory requirement for timely filing. Specifically, Petitioner has not contended
that there existed events beyond its capacity to control preventing it from filing a timely
request for hearing.

As previously noted, Petitioner provides a chronological timeline of events in an apparent
effort to provide good cause for its untimely filing. P. Br. at 1. Petitioner notes that it
opted to submit a POC which it claims was accepted, and a revisit survey was scheduled.
P. Br. at 1. Petitioner further asserts that on September 4, 2008, CMS notified Petitioner
that it was extending the termination date to September 24, 2008. P. Br. at 2. Petitioner
relies on certain events in the timeline it provides to justify why it submitted its request
for hearing untimely. However, Petitioner’s reliance on these events is misplaced.
Petitioner’s submission of a POC and its request for, and CMS’s scheduling of, the
August revisit do not toll the running of the 60-day appeal period. The filing of a plan of
correction and scheduling of a revisit survey are procedures which are separate and
distinct from appeal rights provided to Medicare providers under federal regulations.
Opting to file a POC does not constitute a substitution for the filing of a request for
hearing nor does it in any way establish good cause for failure to file a request for hearing
within the regulatory time frame. Petitioner has not established that the failure to file a
timely request for hearing was due to circumstances beyond it control.

C. Petitioner did not file a request for hearing challenging the August revisit
findings.

Petitioner acknowledges that based on the findings from the August revisit CMS
determined that Petitioner remained out of substantial compliance. P. Br. at 2-3. CMS
advised Petitioner by notice dated September 4, 2008, that it could submit another POC.
Petitioner concedes that the September notice from CMS also advised Petitioner that it
had “sixty (60) days from th[e] date that the September 4, 2008 letter was received” to
appeal the findings of the August revisit survey. P. Br. at 2.

Petitioner did not file a request for hearing to challenge the August revisit survey
findings. Instead, Petitioner, on September 17, 2008, chose to file a “rebuttal response”
to the revisit findings as part of its corrective action plan, and its request it be resurveyed.
CMS Ex. 8. Petitioner then wrote to CMS on October 8, 2008, requesting CMS to
respond to its September 17, 2008 “rebuttal response.” CMS Ex. 9. On November 26,
7

2008, Petitioner, without referencing a request for hearing, wrote to Alan Dorn, the
Acting Chief Counsel for the Office of General Counsel, inquiring as to when the ALJ
hearing would take place. CMS Ex. 11, at 1. It is unclear as to how Petitioner came to
labor under the belief that it had filed a request for hearing. The time period to perfect an
appeal of the findings of the August revisit survey, conveyed to Petitioner in the
September 4, 2008 notice, had expired. Petitioner is legally presumed to have received
CMS’s September notice on September 9, 2008. Therefore, Petitioner should have filed
its request for hearing no later than Saturday, November 8, 2008. Petitioner did not do
so.

While Petitioner does not make specific arguments as to the August revisit survey,
Petitioner does assert that it’s “intentions were to proceed to hearing on this case,” and
states that its September 8, 2008 letter “referencing a request for hearing” should be
recognized as a request for hearing. P. Br. at 2. The September 8, 2008 letter from the

law firm of Miller, Canfield, Paddock and Stone, LLC, is addressed to:

CMS
Department of Health, State of Indiana

The letter is directed to: “To Whom It May Concern:” CMS Ex. 11, at 2.

A review of the letter establishes that there was no specific reference to a request for
hearing. Rather, the letter states: “Mr. MacKelvie will represent us in our upcoming
Administrative Law Judge hearing.” CMS Ex. 11, at 2. I find no basis to construe the
September 8, 2008 letter as constituting a request for hearing. It neither evidences an
intent by Petitioner to request a hearing, nor does it comply in any respect with the
requirements for content of a request for hearing as set forth at 42 C.F.R. § 498.40(b)(1)
and (2). A party requesting a hearing must specify the issues and CMS’s findings of fact
and conclusions of law with which it disagrees, and it must specify the basis for
contending that these findings and conclusions are incorrect. 42 C.F.R. § 498.40(b)(1)
and (2). Petitioner’s September 8, 2008 letter fails to even mention the findings of
noncompliance that were cited during the August revisit. Indeed, nowhere in the
September 8, 2008 letter does Petitioner affirmatively state that it was filing a request for
hearing challenging the findings of the August revisit. Therefore, I find Petitioner’s
assertion that the September 8, 2008 letter constitutes a request for hearing to be without
evidentiary support, and is thus unavailing. Therefore, based on my review of the entire
record in this case, the only request for hearing filed by Petitioner is the untimely request
for hearing dated September 3, 2008.

Petitioner also makes reference to contact with CMS officials and responses from CMS
personnel which Petitioner apparently believes supports its contention that a hearing
request had been filed. However, Petitioner makes no legal argument as to how those

8

statements prove a hearing request was filed or how those contacts in any way toll the 60-
day time frame to file a request for hearing. Petitioner further argues that the record
establishes that there was “frequent participation” by Petitioner and that Petitioner
intended to proceed to hearing in this case. P. Br. at 2. Again, Petitioner fails to explain
how its conduct fulfills the requirement of filing a timely request for hearing or how such
participation and intentions demonstrate good cause. The record is clear that Petitioner
filed a single untimely request for hearing appealing the findings of the June survey.
Furthermore, the evidence is clear that Petitioner’s request for hearing was not filed
within 60 days of CMS’s June notice.

Petitioner had legal representation from two separate law firms, and Petitioner’s counsel
knew or should have known the federal appeal processes and related timeline filing
requirements. Petitioner may have been actively involved in attempting to preserve its
Medicare provider agreement from being terminated, but it failed to preserve its right for
a hearing. Both notices issued by CMS clearly and unequivocally provided Petitioner
with ample and clear notice of its rights to appeal and the process to be utilized in
perfecting such an appeal. CMS Ex. 3; CMS Ex. 7. Petitioner’s response brief does not
establish that Petitioner’s late filing was due to circumstances beyond its control, nor do
the events support an argument that Petitioner may not have received adequate notice
from CMS ina timely manner. Accordingly, Petitioner has failed to show good cause.
The burden is squarely on Petitioner to ensure it follows the requirements if it wishes to
seek a hearing. Petitioner failed to do so in this case.

V. Conclusion

Having considered the parties’ arguments and the complete record before me, I find that
Petitioner failed to file a request for hearing within the applicable regulatory time period
as contemplated by 42 C.F.R. § 498.40(a)(2). I further find that Petitioner has not shown
good cause to extend the period for filing its request for hearing. Accordingly, the CMS
motion to dismiss the request for hearing is granted. For the forgoing reasons,
Petitioner’s September 3, 2008 request for a hearing is dismissed.

/s/
Alfonso J. Montano
Administrative Law Judge