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                              Azria Health Olathe, DAB CR5790 (2020)
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Azria Health Olathe, DAB CR5790 (2020)








  
  
    

  
      
Department of Health and Human Services 
    DEPARTMENTAL APPEALS BOARD
          Civil Remedies Division





Azria Health Olathe
(CCN: 17-5557),
Petitioner,

v.

Centers for Medicare & Medicaid Services.
Docket No. C-17-930Decision No. CR5790December 31, 2020

        
              
    

      DECISION

Azria Health Olathe (Petitioner or facility), a skilled nursing facility (SNF), frequently failed to treat Resident 1's left heel after a pressure wound formed.  Several months later, the wound deteriorated to a point where a physician recommended amputation.  The Centers for Medicare & Medicaid Services (CMS) found that Petitioner was out of substantial compliance with Medicare program participation requirements and that its noncompliance posed immediate jeopardy to the health and safety of its residents.  Based on the facility's noncompliance, CMS imposed civil money penalties (CMP).

Petitioner argues that its treatments and care complied substantially with the requirements for treating pressure wounds, but Petitioner also argues in the alternative that the pressure wound requirements are inapplicable because the resident had a vascular wound, not a pressure wound.  Petitioner further disputes the immediate jeopardy determination, the duration of the immediate jeopardy period, and the reasonableness of the CMP amounts imposed.

The record in this case shows that Petitioner's wound was caused, at least in part, by pressure.  In addition, the record indicates that Petitioner's staff failed to properly treat

**Page 2**

that wound, which contributed to the deterioration of that wound.  Therefore, the facility was out of substantial compliance with the regulations for treating pressure wounds.  The record also supports CMS's immediate jeopardy determination, including the duration of the immediate jeopardy period, and the CMP amounts imposed.

I.  Legal Framework

The Medicare program "provides basic protection against the costs of . . . related post‐hospital . . . care" for individuals over the age of 65 who are eligible for Social Security retirement benefits and for individuals under 65 who meet other criteria.  42 U.S.C. § 1395c.  Post-hospital care includes extended care services provided at an SNF.  42 U.S.C. §§ 1395f(a)(2)(B), 1395x(h)-(i).

For Medicare program purposes, an SNF is an institution that is primarily engaged in providing skilled nursing care and/or rehabilitation services for its residents, but is not primarily engaged in the care and treatment of mental diseases.  42 U.S.C. §§ 1395x(j), 1395i-3(a)(1).  Because an SNF is a "provider of services" in the Medicare program, each SNF that participates in the program must file a provider agreement with the Secretary of Health and Human Services (Secretary).  42 U.S.C. §§ 1395cc(a), 1395x(u).  Further, a participating SNF must meet a variety of ongoing requirements related to how it provides services, maintains the rights of its residents, and administers its facility.  42 U.S.C. § 1395i-3(a)(3), (b)-(d); 42 C.F.R. pt. 483, subpt. B.1

When an SNF fails to meet a statutory or regulatory participation requirement, then the SNF has a "deficiency."  42 C.F.R. § 488.301; *see* 42 U.S.C. § 1395i-3(h)(1).  "Noncompliance" means "any deficiency that causes a facility to not be in substantial compliance."  42 C.F.R. § 488.301.  To maintain "substantial compliance," an SNF's deficiencies may "pose no greater risk to resident health or safety than the potential for causing minimal harm."  42 C.F.R. § 488.301.

Broadly, noncompliance that subjects an SNF to enforcement remedies is divided into two levels.  One level is comprised of deficiencies that immediately jeopardize the health or safety of residents and the other level is composed of deficiencies that do not.  42 U.S.C. § 1395i-3(h)(1).  "Immediate jeopardy" exists when "the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident."  42 C.F.R. § 488.301.

The Secretary contracts with state agencies to conduct surveys to determine whether SNFs are in substantial compliance.  42 U.S.C. §§ 1395aa(a), 1395i-3(g); 42 C.F.R. § 488.10.  These surveys can be unannounced surveys that occur at least once every 15

**Page 3**

months or can be in response to a complaint.  42 U.S.C. § 1395i-3(g).  When the results of a survey show that an SNF is not in substantial compliance with program participation requirements, the Secretary may impose enforcement remedies on the SNF.  42 U.S.C. § 1395i-3(h)(2); 42 C.F.R. § 488.406.  When CMS selects an enforcement remedy to impose on an SNF, it determines the scope (i.e., the number of residents affected or potentially affected) and severity (i.e., the degree of harm or potential harm) for each deficiency.  *See* 42 C.F.R. § 488.404(a)-(b).

One such enforcement remedy is a CMP.  42 U.S.C. § 1395i-3(h)(2)(B)(ii).  CMS may impose a per‐instance CMP for each instance of the SNF's noncompliance or a per‐day CMP for the number of days an SNF is not in substantial compliance.  42 U.S.C. § 1395i‐3(h)(2)(A), (h)(2)(B)(ii)(I); 42 C.F.R. § 488.430(a).  For CMPs assessed on or after February 3, 2017, and for deficiencies that occurred after November 2, 2015, the CMP amounts may range as follows:  $2,097 to $20,965 for per-instance CMPs; $105 to $6,289 per day for less serious noncompliance; or $6,394 to $20,965 per day for more serious noncompliance that poses immediate jeopardy to the health and safety of residents.  45 C.F.R. § 102.3 (2017); 82 Fed. Reg. 9,174-75, 9,182-83 (Feb. 3, 2017); *see* 42 C.F.R. § 488.438(a)(1) (CMP amounts before statutory inflation adjustments).

If CMS imposes a CMP based on a finding of substantial noncompliance, then the SNF may request a hearing before an administrative law judge (ALJ) to challenge CMS's initial determination of noncompliance that led to the imposition of an enforcement remedy and/or the level of noncompliance (if a successful challenge to the level would affect the range of CMP amounts imposed on the SNF).  42 U.S.C. §§ 1320a-7a(c)(2), 1395i‐3(h)(2)(B)(ii); 42 C.F.R. §§ 488.330(e)(3)(ii), 488.408(g)(1), 488.434(a)(2)(viii), 498.3(b)(13)-(14), (d)(10); *see also* 5 U.S.C. §§ 554, 556.  However, CMS's choice of remedies is not reviewable.  42 C.F.R. §§ 488.438(e)(2), 488.408(g)(2), 498.3(b)(13).

If an SNF challenges the existence of a deficiency, CMS must make a prima facie case that the SNF failed to substantially comply with federal participation requirements and, if this occurs, the SNF must then prove substantial compliance by a preponderance of the evidence.  *Hillman Rehab. Ctr.*, DAB No. 1611 at 8 (1997); *see Batavia Nursing & Convalescent Inn*, DAB No. 1911 (2004); *Batavia Nursing & Convalescent Ctr.*, DAB No. 1904 (2004), *aff'd, Batavia Nursing & Convalescent Ctr. v. Thompson*, 129 F. App'x 181 (6th Cir. 2005); *Emerald Oaks*, DAB No. 1800 (2001).  If an SNF challenges CMS's determination as to the level of noncompliance, CMS's determination must be upheld unless it is clearly erroneous.  42 C.F.R. § 498.60(c)(2).

If an ALJ concludes that there was a basis for imposing a CMP on an SNF, then the SNF may dispute the amount of the CMP.  The ALJ's review of the CMP amount is limited to considering the statutory and regulatory factors for setting a CMP amount.  42 C.F.R. § 488.438(e)(3); *see* 42 U.S.C. §§ 1320a-7a(d), 1395i-3(h)(2)(B)(ii)(I); 42 C.F.R. § 488.438(f).  The ALJ may not reduce a CMP to zero.  42 C.F.R. § 488.438(e)(1).

**Page 4**

Either the SNF or CMS may request Departmental Appeals Board (DAB) review of an ALJ's decision.  42 C.F.R. § 498.80.

II.  Background and Procedural History

Petitioner is an SNF that operates in Olathe, Kansas.  Surveyors from the Kansas Department for Aging and Disability Services (state agency) conducted a survey of the facility that concluded on April 25, 2017.  The state agency found that the facility was not in substantial compliance and that the conditions constituted immediate jeopardy. Relevant to this case, the state agency found the following deficiencies, from April 11 through May 2, 2017:

42 C.F.R. § 483.24(a)(2) (Tag F312) (ADL care for dependent residents) at a scope and severity level of "D"2
	42 C.F.R. § 483.25(b)(1) (Tag F314) (Treatment/services to prevent/heal pressure ulcers) at a scope and severity level of "J"3CMS Exhibit (Ex.) 4.

In an April 27, 2017 initial determination, the state agency imposed a denial of payment for new admissions on Petitioner effective May 17, 2017.  CMS Ex. 1 at 1.  On May 18, 2017, CMS issued an initial determination adopting the state agency survey findings and, based on the deficiency at 42 C.F.R. § 483.25(b)(1) (Tag F314), imposed an $8,196 per‐day CMP effective April 11 through April 21, 2017; and a $503 per-day CMP effective April 22, 2017, until the facility returned to substantial compliance.  DAB E‐File Dkt. C‐17-930, Doc. No. 1a.

The state agency revisited the facility and found that Petitioner returned to substantial compliance effective May 3, 2017.  CMS notified the facility that the $503 per-day CMP would be imposed from April 22 through May 2, 2017.  CMS also indicated that the total CMP amount owed by Petitioner was $95,689.  CMS Ex. 2 at 1.

In response, Petitioner requested a financial hardship review regarding the amount of the CMP.  P. Ex. 25.  On August 23, 2017, CMS informed Petitioner that CMS's accountant determined that the facility had demonstrated financial hardship, but that Petitioner could

**Page 5**

make full payment of the CMP if CMS permitted Petitioner to pay the CMP in 12 monthly payments.  CMS Ex. 3 at 1.  Therefore, CMS stated that it agreed to such a payment plan; however, Petitioner had to pay "financing interest."  CMS Ex. 3 at 2.

Petitioner requested a hearing before an ALJ to dispute the initial determination.  The ALJ originally assigned to this case issued an Acknowledgment and Initial Pre-hearing Order (Prehearing Order) that established a prehearing exchange schedule for the parties.  In that order, the ALJ directed the parties to file briefs, proposed exhibits, and written direct testimony for all witnesses they wanted to present in this case.

In compliance with the Prehearing Order, CMS filed an exchange, including a prehearing brief (CMS Pre-hrg. Br.) and 15 proposed exhibits (CMS Exs. 1-15).  CMS submitted written direct testimony for one witness, Amanda Ehrlich, RN.  CMS Ex. 15.  Petitioner filed an exchange, which included a prehearing brief (P. Pre-hrg. Br.), 27 proposed exhibits (P. Exs. 1-27), and nine proposed witnesses, including Frederick W. Short, DO.4
  Petitioner also moved for summary disposition, objected to Ms. Ehrlich's written direct testimony, and requested to cross-examine Ms. Ehrlich.  CMS requested to cross-examine Dr. Short.

**Page 6**

On November 20, 2018, this case was transferred to me.  *See* 42 C.F.R. § 498.44(b).  In an August 22, 2019 Notice of Hearing, I denied Petitioner's motion for summary disposition, overruled Petitioner's objection to Ms. Ehrlich's written direct testimony, admitted CMS Exs. 1-15 and P. Exs. 1-27 into the record, and set this case for hearing on January 14-15, 2020.  In an October 9, 2019 Amended Notice of Hearing, I set the hearing for only one day, January 14, 2020.  On January 14, 2020, I held a hearing in this case.  Both parties timely filed closing briefs (CMS Br. and P. Br., respectively).

III.  Issues

1) Whether Petitioner failed to comply substantially with the requirements of 42 C.F.R. § 483.25(b)(1) (Tag F314, relating to treatment/services to prevent/heal pressure ulcers)5
;

2) If Petitioner was not substantially compliant with 42 C.F.R. § 483.25(b)(1), whether CMS's immediate jeopardy determination with regard to those standards was clearly erroneous; and

3) If Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(b)(1), whether the CMP amount imposed by CMS is appropriate based on the factors in 42 C.F.R. § 488.438(f).  42 C.F.R. § 488.438(e)(3); *see* 42 U.S.C. §§ 1320a‐7a(d), 1395i-3(h)(2)(B)(ii)(I).

IV.  Findings of Fact

Petitioner is an SNF located in Olathe, Kansas, that participates in Medicare.  CMS Exs. 1, 4.
	Until October 24, 2015, Resident 1 lived with his daughter; however, his daughter had Resident 1 taken to Olathe Medical Center for an evaluation because over the preceding two weeks, "he was not getting up, not able to care for himself . . . ."  P. Ex. 2 at 1.**Page 7**

Resident 1 was admitted to the facility on October 27, 2015, after discharge from the acute care hospital.  P. Ex. 1 at 1.
	At the time of admission to the facility, Resident 1 was nearly 79 years old and had a diagnosis of Alzheimer's disease and circulation-related diagnoses such as peripheral vascular disease, ischemic cardiomyopathy, cerebral vascular disease, atherosclerotic heart disease, congestive heart failure, hypertension, cerebral infarction due to thrombosis, and a cardiac pacemaker placement.  P. Ex. 1 at 1-3; P. Ex. 2 at 1-2.
	At the time of admission, Resident 1 had a diagnosis of foot drop for his left foot.  P. Ex. 1 at 2; P. Ex. 2 at 1.
	Upon admission, the facility assessed Resident 1 as at risk for skin breakdown and instituted weekly skin checks and a requirement to "[e]levate heels on pillows at all times while in bed."  *See* CMS Ex. 11 at 36-37.
	On September 7, 2016, staff documented redness on Resident 1's left heel.  CMS Ex. 11 at 50.
	On September 30, 2016, staff documented that Resident 1's left heel area opened.  CMS Ex. 10 at 9; CMS Ex. 11 at 45.
	On September 30, 2016, Dr. Frederick W. Short ordered daily cleansing of the wound and dressing changes as follows:  "Cleanse left heel with normal saline/wound cleanser, apply foam dressing and change dressing daily."  P. Ex. 3 at 1; P. Ex. 16 ¶ 5; *see* P. Ex. 4 at 1.
	On October 4, 2016, Resident 1's open area on his left heel measured 1.5 cm x 0.5 cm.  CMS Ex. 11 at 45.  The open area was bleeding, had blanchable redness, and was "mushy" to the touch.  P. Ex. 4 at 2.
	The Treatment Administration Record (TAR) shows that the facility failed to change Resident 1's dressing for 21 days in October 2016.  CMS Ex. 10 at 1.
	On November 11, 2016, the resident received a new order to change his dressings once every three days.  CMS Ex. 10 at 5.
	On November 20, 2016, staff noticed "dark/brownish red" foul smelling drainage from the wound and notified the resident's physician, Dr. Short, who ordered:  "cleanse with NS/WC, pat dry, apply Metronidazole gel, cover with a perforated**Page 8**

dressing, wrap with Kerlix and tape in place.  Change dressing once daily as needed until healed."  P. Ex. 3 at 3-4; P. Ex. 16 ¶ 9; CMS Ex. 10 at 15.

On November 23, 2016, staff documented the wound as having a black center and a noxious odor.  CMS Ex. 10 at 16; CMS Ex. 11 at 45, 47; *see also* P. Ex. 16 ¶ 10.
	On November 25, 2016, Dr. Short referred Resident 1 to an outside consultant wound clinic, Shawnee Mission Medical Center Wound Clinic (SMMC), to receive weekly wound care treatments for his left heel.  P. Ex. 16 ¶ 12; P. Ex. 4 at 4; P. Ex. 27.
	From December 2016 through about January 2017,****SMMC provided weekly assessments and managed the treatment of Resident 1's left heel wound.  P. Ex. 27.6
	On December 1, 2016, a physician at SMMC assessed Resident 1's left heel wound as a pressure wound.  CMS Ex. 12 at 46; P. Ex. 27 at 17.  The physician directed that there should be "no pressure to wound."  CMS Ex. 12 at 47.
	Throughout the month of December 2016, physicians ordered that Resident 1's dressings be changed daily.  CMS Ex. 12 at 47; P. Ex. 3 at 4, 7; P. Ex. 27 at 2, 4, 6, 8.
	The TAR shows that the facility did not change Resident 1's dressings on seven days in December 2016 (i.e., December 1, 6, 7, 9, 15, 16, and 31).  CMS Ex. 12 at 4, 6.
	Throughout the month of January 2017, Resident 1 had orders to change his dressings daily.  CMS Ex. 12 at 8; P. Ex. 27 at 10, 12, 14.
	The TAR shows that the facility did not change the resident's dressings on seven days in January 2017 (i.e., January 2, 5, 6, 9, 13, 16, and 21).  CMS Ex. 12 at 8.
	In multiple Minimum Data Set (MDS) assessments, the facility documented Resident 1's wound as an unstageable pressure ulcer.  CMS Ex. 10 at 40-41 (February 3, 2017 MDS assessment); CMS Ex. 10 at 43 and CMS Ex. 11 at 1 (March 8, 2017 MDS assessment); CMS Ex. 11 at 3-4 (March 25, 2017 MDS assessment).**Page 9**

In multiple MDS assessments, the facility documented that Resident 1 had "0" venous or arterial ulcers.  CMS Ex. 10 at 39 (November 3, 2016 MDS assessment); CMS Ex. 10 at 42 (February 3, 2017 MDS assessment); CMS Ex. 11 at 2 (March 8, 2017 MDS assessment).
	On February 2, 2017, Dr. Short authorized a change in the wound care consultant for Resident 1, from SMMC to Wound Care Plus, who could provide in-house visits.  P. Ex. 3 at 9.  During February and March 2017, Wound Care Plus provided weekly assessments and managed the treatment of Resident 1's left heel wound.  CMS Ex. 12 at 48-50; CMS Ex. 13 at 1-8, 10-32.
	On February 6, 2017, Wound Care Plus documented Resident 1's wound type as both "Venous/Full Thickness" and "Pressure Ulcer/Injury" and noted a diagnosis of "[p]ressure ulcer of left heel, unstageable."  CMS Ex. 13 at 11-12.  The consultants also measured the wound at 4.5 cm x 5.2 cm x 0.3 cm.  CMS Ex. 13 at 11.
	Wound Care Plus treated Resident 1's wound as a pressure wound by ordering, among other things, regular repositioning and pressure-relieving devices like boots and heel protectors.  *See, e.g.,* CMS Ex. 13 at 11; *see also* P. Ex. 4 at 19-20.
	On February 28, 2017, the facility initiated new interventions for "preventative skin care to protect again[st] new wounds," which included a low air loss (LAL) mattress to reduce pressure on Resident 1 while in bed and instructions to "off load heel," or for Resident 1 to wear a "protective boot."7
  CMS Ex. 11 at 43.
	On March 2, 2017, Dr. Short clarified an order to "apply Blue Boots to [left] foot when [Resident 1] is in bed" (as opposed to when Resident 1 is up).  P. Ex. 3 at 13.
	From November 2016 through March 2017, Resident 1 was prescribed antibiotics for infections related to his left heel.  P. Ex. 3 at 3 (November 2016); CMS Ex. 10 at 12 (November 2016); P. Ex. 4 at 5-6 (December 2016); CMS Ex. 11 at 18-19 (December 2016); P. Ex. 4 at 11-12, 14 (January 2017); CMS Ex. 11 at 24-26 (January 2017); P. Ex. 4 at 15, 17 (February 2017); CMS Ex. 11 at 14-16 (February 2017); P. Ex. 4 at 23-25 (March 2017).
	On March 25, 2017, Petitioner's staff sent Resident 1 to Olathe Medical Center after observing that he had jerking movements, restlessness of his upper**Page 10**

extremities, increased confusion and mumbling, and an oxygen saturation of only 75%.  CMS Ex. 14 at 1; P. Ex. 4 at 26.

A vascular surgeon at Olathe Medical Center, Dr. Daniel P. Connelly, assessed Resident 1's left heel wound as "a pressure sore on his left heel which extends down to the calcaneus" and recommended an above-knee amputation.  CMS Ex. 14 at 9.
	On March 29, 2017, Resident 1 was discharged to inpatient hospice.  CMS Ex. 14 at 41, 43.
	The facility's Skin Care Treatment Regimen policy originally adopted December 3, 2015, and revised February 20, 2017, required the facility to ensure prompt identification, documentation, and to obtain appropriate topical treatment for residents with skin breakdown.  The procedures further indicated that the wound care nurse or designee administers routine daily wound care treatment, including dressing changes, and that routine wound care is documented on the TAR.  CMS Ex. 9 at 1.
	At the hearing, Amanda Ehrlich, RN testified that failing to change dressings daily on a pressure wound as ordered "could lead to deterioration of the wound or an increase in . . . the size or staging of the wound or infection."  Transcript (Tr.) at 61-62.  Ms. Ehrlich further explained that, "if [staff are] not changing the dressing and applying the topical medications that were prescribed and cleansing the wound as prescribed, it could lead to infection."  Tr. at 62.
	Petitioner submitted financial documents covering a period from roughly November 2016 through May 2017.  P. Ex. 25.  The balance sheets provided appear to show liabilities growing to more than double the facility's assets (and a growing negative members' equity balance).  P. Ex. 25 at 7, 20, 33, 46, 59, 72.  The monthly income statements all show net losses.  P. Ex. 25 at 8, 21, 34, 47, 60, 73.V.  Conclusions of Law and Analysis

***1. Petitioner was not in substantial compliance with 42 C.F.R. §*** ***483.25(b)(1) (Tag F314) because it frequently failed to change Resident 1's dressings as ordered.***

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.  42 U.S.C.

**Page 11**

§ 1395i-3(b); 42 C.F.R. § 483.25.  To this end, the facility must (among other requirements) ensure that a resident who enters the facility without pressure sores does not develop them unless his clinical condition shows that they were unavoidable, based on the resident's comprehensive assessment.  42 C.F.R. § 483.25(b)(1)(i).  If the resident already has pressure sores, the facility must ensure that he receives the treatment and services necessary to promote healing, prevent infection, and prevent new sores from developing.  42 C.F.R. § 483.25(b)(1)(ii).

In assessing the facility's compliance with this requirement, the relevant question is:  did the facility "take all necessary precautions" to promote healing, prevent infection, and prevent new sores from developing.  If it 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, it has violated the regulation.  *Senior Rehab. & Skilled Nursing Ctr.*, DAB No. 2300 at 13-14 (2010), *aff'd, Senior Rehab. & Skilled Nursing Ctr. v.* *Health & Human Servs*., 405 Fed. App'x 820 (5th Cir. 2010); *Koester Pavilion*, DAB No. 1750 at 32 (2000).

As noted, Resident 1's left heel opened on September 30, 2016, and the resident received physician orders for staff to clean the wound and change his dressings.  CMS Ex. 10 at 9; P. Ex. 3 at 1.  During the months of October 2016, December 2016, and January 2017 specifically, the resident had orders to change his dressings daily.8
  CMS alleges in its brief and in the statement of deficiencies that the facility failed to follow those orders.  CMS Br. at 5-7; CMS Ex. 4 at 11-12 (October), 15 (December), 16 (January).  In response, Petitioner argues that the "purported chart misses here and there across [the facility's] six months of treating [Resident 1's] heel wound . . . ignores the enormous amount of care and treatment (plus documentation) that the facility provided to [Resident 1]."  P. Br. at 17.  Petitioner argues that the facility's skin treatments overall were in substantial compliance with the regulation and that it documented all details of the wound.  P. Br. at 16-17.

The documentation in the record shows that the facility missed changing the resident's dressings frequently and not just "here and there" as Petitioner contends.  The facility's staff tracked the dressing changes on the TAR, and when there were orders for daily dressing changes in October 2016, December 2016, and January 2017, the TAR shows that the facility failed to change Resident 1's dressing for 21 days in October 2016, seven days in December 2016, and seven days in January 2017.  P. Ex. 3 at 1 (September 30 order); CMS Ex. 10 at 1 (October TAR); CMS Ex. 12 at 47 (SMMC December order); CMS Ex. 12 at 4, 6 (December TAR showing missed dressing changes on December 1, 6, 7, 9, 15, 16, and 31); CMS Ex. 12 at 8 (January TAR showing missed dressing changes on January 2, 5, 6, 9, 13, 16, and 21); P. Ex. 3 at 4, 7 (orders dated November 20 and

**Page 12**

December 8, 2016).  Thus, the facility failed to provide daily dressing changes as ordered for two thirds of October 2016 and almost a quarter of both December 2016 and January 2017.9

Despite the facility's other efforts to treat the resident's heel wound, the frequency of the missed dressing changes shows that the facility failed to "take all necessary precautions" to promote healing and prevent infection of Resident 1's wound.10
  The facility's failures placed Resident 1 at risk of more than minimal harm.  At the hearing, Ms. Ehrlich testified that failing to change dressings daily on a pressure wound as ordered "could lead to deterioration of the wound or an increase in . . . the size or staging of the wound or infection."  Tr. at 61-62.  Ms. Ehrlich further explained that "if [staff are] not changing the dressing and applying the topical medications that were prescribed and cleansing the wound as prescribed, it could lead to infection."  Tr. at 62.  It is no surprise that the resident's****wound continued to deteriorate under the facility's care.  The wound deteriorated and grew in size (CMS Ex. 13 at 11), emitted a "noxious" and "foul" odor (CMS Ex. 11 at 45; CMS Ex. 10 at 16; P. Ex. 10 at 64), became unstageable (CMS Ex. 10 at 41; CMS Ex. 12 at 49), and eventually amputation was recommended.  CMS Ex. 14 at 9.  Accordingly, based on the facility's frequent failures to change Resident 1's dressings daily as ordered, I conclude the facility was out of substantial compliance with the requirement to provide "necessary treatment and services . . . to promote healing [and] prevent infection."  42 C.F.R. § 483.25(b)(1).

Aside from Petitioner's argument that its treatments substantially complied with the regulation for treating pressure sores, Petitioner's main argument in challenging the deficiency is that the pressure sore regulation at 42 C.F.R. § 483.25(b)(1) is inapplicable because Resident 1's left heel wound was not caused by pressure at all, but by vascular issues.  P. Br. at 8-14.  Petitioner contends Resident 1 had a vascular wound, not a pressure wound, and so the deficiency cited under tag F314 should be dismissed.  P. Br. at 13-14.

**Page 13**

Petitioner cites Dr. Short's testimony to explain that a lack of blood flow from vascular (or more specifically, arterial) issues causes a wound to form "from the bottom to the top" rather than "from the surface of the skin down" as with pressure.  P. Br. at 10; Tr. at 121; *see also* Tr. at 63 (surveyor testifying that "there is nothing externally that you could do to treat an ulcer that was [] vascular").  Specifically, an arterial ulcer is ulceration that occurs as a result of arterial occlusive disease when "non-pressure related disruption or blockage of the arterial blood flow to an area causes tissue necrosis."  P. Br. at 9.  According to Petitioner, "the only way to successfully heal the wound would be to address the underlying venous/arterial (or vascular) compromise."  P. Br. at 10; P. Ex. 16 ¶ 20.

Petitioner relies on physician testimony to support its argument that Resident 1's left heel wound was a vascular wound.  Dr. Short testified that he examined the heel on November 7, 2016, and determined that it was "vascular in nature."  P. Br. at 4, 9; P. Ex. 16 ¶ 7.  Dr. Short's opinion was also based on his review of a November 25, 2016 ultrasound report.  P. Br. at 9; P. Ex. 8; P. Ex. 16 ¶¶ 14-15.  Additionally, Petitioner cites a statement from Dr. Robert Dorsey, a consulting vascular surgeon with the outside wound clinic, Wound Care Plus.  Dr. Dorsey opined that the left heel wound was a "medically unavoidable vascular (arterial) wound" and that "pressure was not a causative factor in the development or deterioration of this wound."  P. Ex. 17 at 1; P. Br. at 9-10.  Dr. Dorsey stated that the decreased blood flow to Resident 1's left foot "was the major factor in the etiology of the open wound."  P. Ex. 17 at 1.

Despite the testimony from Dr. Short and the written statement from Dr. Dorsey, the weight of the evidence in the record does not support the conclusion that Resident 1's sore was caused by vascular issues, or at the least, entirely by vascular issues.  Rather, the weight of evidence in the record is that Resident 1's sore was a pressure sore.  Accordingly, the facility's failure to properly care for the part of the wound caused by pressure still places the facility out of substantial compliance with the regulations.

It is difficult to fully accept Dr. Short's testimony and Dr. Dorsey's statement when the contemporaneous documentation does not corroborate their testimony.  For instance, Petitioner contends that Dr. Short's opinion about the vascular nature of Resident 1's wound was based on his examination of Resident 1's heel on November 7, 2016, and his review of the findings from the November 25, 2016 ultrasound report.  P. Br. at 4, 9.  However, it does not appear that Dr. Short documented this conclusion.  In any event, long after November 2016, Dr. Short continued to order treatments to address concerns related to pressure.  As late as March 2, 2017, Dr. Short updated an order for pressure-relieving boots for the resident when in bed.  P. Ex. 3 at 13; P. Br. at 15.  During the hearing, Dr. Short also acknowledged that, to treat a vascular wound, the resident would need surgical intervention, such as "doing a balloon to try to open his artery" and "the major option you were looking at was either below-the-knee or above-the-knee amputation."  Tr. at 122-23.  Yet there is no documentation showing that he ever

**Page 14**

considered such interventions while treating the resident, before it was suggested by Dr. Connelly, the vascular consultant from Olathe Medical Center in March 2017.11

Dr. Dorsey's opinion was similarly inconsistent with the documentation from his associates at Wound Care Plus, who noted the cause of Resident 1's wound as both pressure and arterial.  *See, e.g.*, CMS Ex. 12 at 48-50.  Throughout its care of Resident 1, Wound Care Plus treated Resident 1's wound as a pressure wound by ordering, among other things, heel protectors and "keep[ing] pressure off heel."  P. Ex. 27.  Dr. Dorsey's testimony was not submitted in the form of an affidavit or written declaration as required by the Prehearing Order.  Therefore, I do not give his statement the same weight as sworn testimony or testimony made under penalty of perjury.12
  Prehearing Order at 6.

In addition, two other physicians diagnosed Resident 1 with a pressure sore.  The first wound care consultant, SMMC, assessed Resident 1 with a left heel pressure ulcer in December 2016.  CMS Ex. 12 at 46.  And months later, when Resident 1 was transferred to Olathe Medical Center in March 2017, he underwent a vascular consultation with Dr. Connelly, who noted that Resident 1 "has a pressure sore on his left heel which extends down to the calcaneus."  CMS Ex. 14 at 9.  Dr. Connelly's impression was "[p]ressure ulceration of [Resident 1's] left heel" and he noted that, "I do not think that any efforts towards limb salvage should be pursued [and] [g]iven [Resident 1's] current mental status, I think that and with regards to his wound care, I believe that an above-the-knee amputation would be the most appropriate therapy for him."  CMS Ex. 14 at 9.

Petitioner's staff obviously agreed that the weight of medical opinion showed that Resident 1 had a pressure ulcer because they consistently documented Resident 1's wound as a pressure ulcer in MDS assessments.  CMS Ex. 10 at 40-41, 43; CMS Ex. 11 at 1, 3-4.  Significantly, facility staff indicated in those MDS assessments that Resident 1 did not have a venous or arterial ulcer.  CMS Ex. 10 at 39, 42; CMS Ex. 11 at 2; *see also* Tr. at 100.  I find unpersuasive Petitioner's unsupported assertion that the MDS documents reveal a mistake by the facility in checking boxes on the MDS form.

**Page 15**

It is also worth noting that, under SOM guidelines, SNFs are expected to have specific documentation of an ulcer "if the ulcer has characteristics consistent with a pressure ulcer, but is determined not be one."  P. Ex. 12; SOM – Guidance to Surveyors for Long Term Care Facilities, CMS Pub. 100-07, App. PP at 152, 2018 (rev. 70, eff. Oct. 1, 2010), *available at* https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R70SOMA.PDF.  In particular, "[a]t the time of the assessment and diagnosis, the clinician is expected to document the clinical basis (e.g., underlying condition contributing to the ulceration, ulcer edges and wound bed, location, shape, condition of surrounding tissues) which permit differentiating the ulcer type."  SOM, App. PP at 152, 208.  There is no such specific documentation in the record showing that the facility had assessed and determined that Resident 1's left heel wound was not caused by pressure.

Thus, I find that the weight of the evidence in the record supports that Resident 1's left heel wound was caused by pressure, or at least caused in part by pressure and was not caused entirely by vascular issues.  The requirements for treating pressure wounds, therefore, apply and, for the reasons discussed above, the facility was out of substantial compliance as it failed to take "all the necessary steps" to promote healing and to prevent infection.

***2. CMS's determination that Petitioner's noncompliance with 42 C.F.R. § 483.25(b)(1) posed immediate jeopardy to resident health and safety is not clearly erroneous.***

Immediate jeopardy exists if a facility's noncompliance has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.  42 C.F.R. § 488.301.  The regulation does not require that a resident *actually* be harmed.  *Lakeport Skilled Nursing Ctr.*, DAB No. 2435 at 8 (2012).  I must uphold CMS's determination as to the level of a facility's substantial noncompliance (which includes an immediate jeopardy finding) unless it is "clearly erroneous."  42 C.F.R. § 498.60(c).  The "clearly erroneous" standard imposes on facilities a heavy burden to show no immediate jeopardy, and the DAB has sustained determinations of immediate jeopardy where CMS presented evidence "from which '[o]ne could reasonably conclude' that immediate jeopardy exists."  *See, e.g.*, *Barbourville Nursing Home*, DAB No. 1962 at 11 (2005) (quoting *Florence Park Care Ctr.*, DAB No. 1931 at 27-28 (2004)).

Petitioner disputes the immediate jeopardy determination, by adding to its theory that Resident 1's wound was caused entirely by vascular issues and not by pressure.  Petitioner argues that the development of Resident 1's vascular wound was, in fact, "clinically unavoidable" because, in its view, this was "an extremely rare instance" where a resident's underlying medical issues "makes decline inevitable regardless of treatment."  Petitioner points to Dr. Dorsey's description of Resident 1's left foot as "doomed" and to Dr. Short's determination that successful healing was impossible without addressing the

**Page 16**

resident's underlying vascular problems.  Because Resident 1 had a vascular wound that was clinically unavoidable, Petitioner contends, the specific allegations in this case of improper treatment of Resident 1's heel for pressure issues could not cause, nor be likely to cause, serious harm.  P. Br. at 19.

As explained above, however, the weight of the evidence in the record does not support the finding that Resident 1's wound was caused entirely by Resident 1's vascular issues, but instead supports that there was at least a pressure component to Resident 1's wound.  Petitioner also does not argue that Resident 1 had a *pressure* wound that was clinically unavoidable (as opposed to a vascular wound that was clinically unavoidable) or point to evidence to support such a finding.  One could argue that Resident 1's underlying vascular problems made it more critical for staff to do its part to address the pressure component of the wound's development.  In any case, the facility's failure to follow physician orders to change dressings daily was likely to—and did—cause serious injury or harm to Resident 1.  As noted, at the hearing, Surveyor Ehrlich testified that failing to change dressings daily on a pressure wound as ordered "could lead to deterioration of the wound or an increase in . . . the size or staging of the wound or infection."  Tr. at 61-62.  The facility's frequent failures to change Resident 1's dressings contributed to the deterioration of the wound, which grew in size, emitted "noxious" odors, and became unstageable.  CMS Ex. 10 at 16, 41; CMS Ex. 12 at 49; CMS Ex. 13 at 11 (wound measure).  Further, Resident 1 was nearly always on antibiotics from November 2016 through March 2017 due to infection from the sore on his left foot.  P. Ex. 3 at 3; P. Ex. 4 at 5-6, 11-12, 14, 23-25; CMS Ex. 10 at 12; CMS Ex. 11 at 14-16, 18-19, 24-26.

Thus, there is no question that Resident 1 was seriously harmed as his wound deteriorated to the point where Resident 1 ran a fever despite his antibiotic regimen and an above‐the‐knee amputation was recommended.  CMS Ex. 14 at 7, 9.  All of these reasons support the finding that the facility's noncompliance caused serious harm and injury to Resident 1.  Therefore, I conclude that CMS did not clearly err in determining that Petitioner's noncompliance with 42 C.F.R. § 483.25(b)(1) posed immediate jeopardy to resident health and safety.

***3. CMS's determination that the immediate jeopardy period ran from April 11 through April 21, 2017, is not clearly erroneous.***

Petitioner briefly disputes the duration of the immediate jeopardy period, which CMS determined to run from April 11 through April 21, 2017.  According to Petitioner, there is no "rational relationship" with that immediate jeopardy period and the citations against the facility for failing to perform assessments and to implement certain treatments during a period from September 2016 through March 2017.  P. Br. at 21.  I find Petitioner's arguments unavailing.

**Page 17**

As discussed above, the facility failed to treat Resident 1's heel wound by failing to follow orders to change the resident's dressings daily.  The facility's failures, which put the facility out of substantial compliance at the immediate jeopardy level, started at least as early as October 2016.

Even though the facility's care for Resident 1 may have ended by March 2017, its noncompliance at the immediate jeopardy level did not by necessity end at the same time.  Noncompliance is presumed to continue until the facility demonstrates that it has achieved substantial compliance.  *Cary Health & Rehab. Ctr.*, DAB No. 1771 at 23-24 (2001); *see also Park Manor Nursing Home*, DAB No. 2005 at 26 (2005), *aff'd sub nom. Park Manor, Ltd.*,*v. U.S. Dep't of Health & Human Servs.*, 495 F.3d 433 (7th Cir. 2007).  Further, "[t]he burden is on the facility to show that it timely completed the implementation of [its] plan [of correction] and in fact abated the [immediate] jeopardy (to reduce the applicable CMP range) or achieved substantial compliance (to end the application of remedies)."  *Lake Mary Health Care*, DAB No. 2081 at 29 (2007) (citing *Spring Meadows Health Care Ctr.*, DAB No. 1966 (2005)).  Finally, a "determination by CMS that [an] SNF's ongoing compliance remains at the level of immediate jeopardy during a given period constitutes a determination about the 'level of noncompliance' and, therefore, is subject to the clearly erroneous standard of review under section 498.60(c)(2)."  *Brian Ctr. Health & Rehab./Goldsboro*, DAB No. 2336 at 7-8 (2010).

Petitioner has not offered any evidence showing when it abated the immediate jeopardy level conditions that caused serious harm to Resident 1.  Petitioner did not provide evidence showing when it completed a plan of correction that, for example, addressed its staff's failure to follow physician orders or to document treatment carefully.  The statement of deficiencies instead indicates that the facility did not abate the immediate jeopardy conditions until April 22, 2017, when the facility, among other things, implemented a new skin management program and policy, conducted new Braden assessments on all residents, in-serviced licensed staff on the skin management program and policy, and required skin assessments, TARs, and treatments to be reviewed by the DON, ADON, or designee three times a week and reviewed by the quality assurance committee monthly.  CMS Ex. 4 at 22-23.

Taking these findings together, the record could have supported a much longer period of immediate jeopardy noncompliance, starting as early as October 2016, and running through April 21, 2017.  CMS chose a shorter period within—and consistent with—those dates, from April 11 through April 21, 2017.  I therefore conclude that the duration of the immediate jeopardy period was not clearly erroneous.

***4. The CMPs imposed are reasonable in amount.***

When determining whether a CMP amount is reasonable, I apply the factors listed in 42 C.F.R. § 488.438(f):  1) the facility's history of noncompliance; 2) the facility's

**Page 18**

financial condition; 3) the 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.  *See* 42 U.S.C. §§ 1320a-7a(d)(2), 1395i-3(h)(2)(B)(ii)(I).  The absence of culpability is not a mitigating factor.  42 C.F.R. § 488.438(f).  The factors listed 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.  *See* 42 U.S.C. §§ 1320a-7a(d)(1), (3), 1395i-3(h)(2)(B)(ii)(I).

The regulations leave the decision regarding the choice of remedy to CMS, and the amount of the remedy to CMS and the ALJ, requiring only that the regulatory factors at §§ 488.438(f) and 488.404 be considered when determining the amount of a CMP within a particular range.  42 C.F.R. §§ 488.408, 488.408(g)(2), 498.3(d)(11); *see also* 42 C.F.R. § 488.438(e)(2), (3); *Alexandria Place*, DAB No. 2245 at 27 (2009); *Kenton Healthcare, LLC*, DAB No. 2186 at 28-29 (2008).  However, unless a facility contends that a particular regulatory factor does not support the CMP amount, an ALJ must sustain it.  *Coquina Ctr.*, DAB No. 1860 (2002).

Here, CMS imposed an $8,196 per-day CMP effective April 11 through April 21, 2017; and a $503 per-day CMP effective April 22 through May 2, 2017.  CMS Ex. 3.  Petitioner only provided an argument for a reduction in the CMP based on its financial condition.

**Financial Condition of the Facility:**Petitioner challenges the total CMP amount imposed as unreasonable in light of its financial condition, arguing that the burden of a $95,689 CMP would "jeopardize its ability to continue as a going concern."  P. Br. at 20-21.  Petitioner submitted financial documents and points out the following factors:  the facility's resident population is approximately 90% Medicaid, which is driving financial losses, including $988,283 cumulative new loss from August 2016 until June 2017; its income from operations cannot cover its capital and ancillary expenses averaging nearly $900,000 annually; the facility is depleting its cash reserve, down to $4,172 in May 2017; and its liabilities are more than twice its assets, which means the facility is financially insolvent.  P. Br. at 20-21.

The evidence shows signs of the facility's poor financial health.  The balance sheets provided appear to show liabilities growing to more than double the facility's assets (and a growing negative members' equity balance).  P. Ex. 25 at 7, 20, 33, 46, 59, 72.  The monthly income statements all show net losses.  P. Ex. 25 at 8, 21, 34, 47, 60, 73.

Despite this evidence, the documentation does not support a reduction in the CMP.  Petitioner submitted financial documents covering just a limited time period, from roughly November 2016 through May 2017.  P. Ex. 25.  Petitioner notes that it acquired the business in August 2016 (P. Ex. 25 at 2 n.1), but the limited period of documents may not reveal a fair picture of the facility's overall condition.  Further, in response to

**Page 19**

Petitioner's request for financial hardship consideration, CMS agreed, as determined by an accountant, to allow Petitioner to pay the total CMP over a 12-month installment plan with financing interest, which would mean monthly payments of $7,974.08 plus interest ($95,689 total CMP over 12 months).  CMS Ex. 3.  Petitioner's income statements appear to show that it has been able to suffer losses substantially greater than that amount in a single month without going out of business.  *See, e.g.*, P. Ex. 25 at 8 (appearing to show net income loss of $135,054 for the month ending December 31, 2016); *see Gilman Care Ctr.*, DAB No. 2357 at 7 (2010) (observing that "[t]he facility has been able to sustain operating losses of up to ten times the CMP amount without closing, making it less credible that paying the CMP would put it out of business.").

**Facility's History of Noncompliance:**  Neither party submitted evidence concerning facility's history of compliance or noncompliance with Medicare program requirements.

**Scope and Severity of Deficiencies and Relationship Between Deficiencies:**  This case involves an immediate jeopardy situation for one resident, and only involves a single deficiency.

**Culpability:**  I find that Petitioner's actions in this case were very culpable.  There is no excuse for its staff's failure to follow physician orders for changing dressings daily or to document that care.  The record shows a pattern of missing dressing changes over several months, apparently resulting in infection and the need for antibiotics to be prescribed for months.  Petitioner's noncompliance was serious as it resulted in the deterioration of Resident 1's wound, to a point where amputation was recommended.  The facility was fortunate that Resident 1's repeated infections to his left heel wound did not result in even more serious harm.

**CMP Amount:**  Finally, I observe that the amounts imposed in this case, $8,196 and $503, are already at the low end of the two CMP ranges ($6,394 and $105, respectively).13
  Further, as found above, Petitioner has not submitted sufficient evidence to justify reducing the CMP amounts based on its financial condition, and, in any event, its culpability is quite high, justifying a substantial penalty.  Therefore, the record fully supports the relatively low CMPs imposed, and I conclude that the $8,196 upper-range CMP and $503 lower-range CMP are reasonable.

**Page 20**

VI.  Conclusion

For the reasons set forth above, I sustain CMS's determination that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(b)(1), conclude that CMS's determination that Petitioner immediately jeopardized Resident 1 was not clearly erroneous, and find that the CMPs imposed by CMS, an $8,196 per-day CMP effective April 11 through April 21, 2017, and a $503 per-day CMP effective April 22 through May 2, 2017, are reasonable and appropriate based on the regulatory factors discussed in this decision.


          /s/
        Scott Anderson

                      Administrative Law Judge
      1. All citations to the Code of Federal Regulations (C.F.R.) are to the version in effect at the time of the survey unless otherwise indicated. back to note 1
                      2. A "D" scope and severity level indicates isolated noncompliance of no actual harm with potential for more than minimal harm that is not immediate jeopardy.  State Operations Manual (SOM), Chap. 7, § 7400.5.1 (rev. 161, eff. Sept. 23, 2016). back to note 2
                      3. A "J" scope and severity level indicates isolated noncompliance that poses immediate jeopardy to resident health and safety.  See SOM, Chap. 7, § 7400.5.1. back to note 3
                      4. Petitioner's witness list indicated that it had nine proposed witnesses.  Of these nine, only one, Dr. Short, submitted a declaration, although that declaration was not signed under penalty of perjury.  P. Ex. 16.  For the remaining eight witnesses, Petitioner submitted a document for each that Petitioner described in its exhibit list as a "Prior written statement."  Although a number of those statements were witnessed by a notary public, none of them were signed under oath or penalty of perjury.  See P. Exs. 17-24.  This contravened Prehearing Order ¶ 8, which required the parties to submit the written direct testimony for each proposed witness "in the form of an affidavit made under oath or as a written declaration that the witness signs under penalty of perjury for false testimony."  This requirement stems from the applicable statute, which provides that the Petitioner is entitled "to present witnesses," and the regulation implementing that provision, which requires that "[w]itnesses at the hearing testify under oath or affirmation."  42 U.S.C. §§ 1320a-7a(c), 1395i-3(h)(2)(B)(ii)(I); 42 C.F.R. § 498.62; see also 5 U.S.C. § 556(c)(1).  An ALJ may direct the parties to submit written direct testimony for witnesses in lieu of obtaining direct testimony during an oral hearing; however, "[a]ny written direct testimony must be in the form of a sworn affidavit or declaration under penalty of perjury."  Civil Remedies Division Procedures (CRDP) §§ 16(b), 19(b); see also 28 U.S.C. § 1746.  At the hearing in the present case, Dr. Short testified under oath that his declaration at P. Ex. 16 constituted his testimony in this case.  Tr. at 69.  Therefore, I accept P. Ex. 16 as Dr. Short's written direct testimony.  However, I do not accord any of the "Prior written statements" that status, and, as a result, give them less weight than I would testimony made under oath or signed under penalty of perjury. back to note 4
                      5. In addition to the deficiency cited under 42 C.F.R. § 483.25(b)(1) (Tag F314), Petitioner also challenges the deficiency cited under 42 C.F.R. § 483.24(a)(2) (Tag F312), arguing that it appealed the "entire survey as the basis for a CMS enforcement remedy" which included § 483.24(a)(2).  P. Br. at 7.  Petitioner, however, has no right to request a hearing with respect to the deficiency cited under § 483.24(a)(2) because I may only review deficiencies that are the basis for the imposition of an enforcement remedy.  42 C.F.R. §§ 488.408(g)(1), 498.3(b)(13); San Fernando Post Acute Hosp., DAB No. 2492 at 7-8 (2012).  As indicated earlier, CMS imposed a CMP based on the deficiency under § 483.24(a)(2) only.  Therefore, I confine my discussion in this decision accordingly. back to note 5
                      6. Petitioner did not mark and paginate P. Ex. 27 as required by the Prehearing Order.  Therefore, when I cite to specific pages in P. Ex. 27, it will be to the page numbers when viewing the exhibit as a pdf file. back to note 6
                      7. The care plan has an undated, handwritten notation of the following intervention:  "to wear offloading shoe on left foot when out of bed."  CMS Ex. 11 at 36. back to note 7
                      8. The dressing change orders in November 2016 varied in frequency, from daily to once every three days.  See, e.g., CMS Ex. 10 at 3, 5. back to note 8
                      9. The October TAR incorrectly recorded the physician's order as "every other day" instead of "daily," which may explain why the facility failed to clean the wound and redress it.  Compare P. Ex. 3 at 1 (order) with CMS Ex. 10 at 1 (TAR). back to note 9
                      10. Petitioner asserts that it documented overall care on the 24-hour reports.  P. Br. at 16 (citing P. Ex. 10).  The documentation submitted, however, begins January 2017 and does not otherwise show that the facility had, in fact, changed the resident's dressing on the missing dates in January (2, 5, 6, 9, 13, 16, and 21).  There were references to the resident's left heel wound on the 24-hour reports for January 2 and 16, but those notes were either illegible or otherwise did not show that dressings were changed.  P. Ex. 10 at 1, 4.  Finally, it was the facility's policy to document dressing changes on the TAR.  CMS Ex. 9. back to note 10
                      11. At the hearing, Dr. Short recognized that Resident 1 was at greater risk for pressure ulcers because of his underlying conditions.  Tr. at 70. back to note 11
                      12. Petitioner further relies on Dr. Dorsey's statement that, "[t]he right heel had no skin breakdown throughout . . . [Resident 1's] course from September 2016 through March 2017" and "[h]ad pressure been a causative factor in the development of the heel wound[,] I would have expected to see breakdown on the right heel and other prominences."  P. Ex. 17 at 1; P. Br. at 10.  This statement alone is unpersuasive as it does not account for the fact that Resident 1 had drop foot on the foot with the sore, which Dr. Short conceded could cause a pressure ulcer.  Tr. at 108.  Additionally, a physical exam in March 2017 revealed that "[Resident 1's] body positioning puts pressure on his left heel."  CMS Ex. 14 at 9. back to note 12
                      13. I may not reduce the CMP amounts below the regulatory minimums.  82 Fed. Reg. at 9182-83.  Even if I reduced the CMPs imposed to the regulatory minimums and for the total number of days possible, the total reduction would amount to just $24,200 (i.e., a $71,489 total CMP if amounts reduced to regulatory minimums).  That amount is less than what Petitioner had offered to pay as the penalty in this case, in its request for financial hardship consideration.  P. Ex. 25 at 3 (requesting that CMS reduce the total CMP to $27,789.40, an amount Petitioner represented it could absorb without imperiling the survival of the facility). back to note 13 Back to top
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