Epione Pavilion, DAB CR6555 (2024)

DECISION

Epione Pavilion (hereinafter referred to as “Epione” or “Petitioner”) challenges the Centers for Medicare & Medicaid Services (CMS) determination of substantial noncompliance with Medicare participation requirements and that the noncompliance posed immediate jeopardy to resident health and safety.  Petitioner also challenges the imposition of a civil monetary penalty (CMP) of $22,320 per day from May 25, 2021 through June 2, 2021, and a CMP of $225 per day for 18 days starting June 3, 2021 through June 20, 2021.

As explained below, the record supports the facility’s noncompliance with Medicare requirements and supports the immediate jeopardy determination.  Based on the evidence, I find that there is a basis for the imposition of enforcement remedies and the per-day CMP amounts imposed by CMS are reasonable.

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I. Background and Procedural History

Epione Pavilion is a skilled nursing facility (SNF) located in Cuba City, Wisconsin that participates in the Medicare program.  P. Br. at 1; see CMS Ex. 9.  The Wisconsin Department of Health Services (state agency) completed a complaint survey at the facility on June 8, 2021.  The state surveyors found, and CMS later agreed, that the facility was not in substantial compliance with the Medicare participation requirement at 42 C.F.R. § 483.25(b)(1)(i)(ii), Treatment/Services to Prevent/Heal Pressure Ulcer, Tag F686, cited at scope and severity (s/s) level J.1  CMS Ex. 6 at 1.

By letter dated June 10, 2021, the state agency informed Petitioner of the results of the survey.  CMS Ex. 1.  By letter dated March 28, 2022, CMS notified Petitioner of the noncompliance determination and the imposition of remedies.  CMS Ex. 6.  CMS explained that the immediate jeopardy was abated on June 3, 2021, but the facility did not regain substantial compliance until June 21, 2021.  CMS Ex. 6 at 1.  CMS imposed a CMP of $22,320 per day from May 25, 2021 through June 2, 2021, and a CMP of $225 per day for 18 days starting June 3, 2021, through June 20, 2021.  The total CMP amount is $204,930.  CMS Ex. 6 at 2.

Petitioner filed a request for hearing on May 23, 2022.  The case was assigned to me for hearing and decision.

On August 22, 2022, CMS timely filed a pre-hearing exchange that included a pre-hearing brief and motion for summary judgment (CMS Br.), in addition to 64 exhibits (CMS Exs. 1-64).  CMS identified three proposed witnesses.

On September 26, 2022, Petitioner timely filed a pre-hearing exchange that included a pre-hearing brief and motion to dismiss CMS’s summary judgment motion (P. Br.), along with 15 exhibits (P. Exs. 1-15).  Petitioner identified one proposed witness.

CMS filed a reply brief on October 11, 2022, along with objections to several of Petitioner’s exhibits.  Petitioner filed a sur-reply and response to CMS’s objections on November 14, 2022.

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II. Admission of Exhibits and Decision on the Record

Absent objection, CMS Exhibits 1-64 are admitted into evidence.

CMS objected to P. Ex. 6, a statement from Dr. Jeffrey White, Resident 2’s (R2’s) treating physician, dated June 17, 2021.  CMS’s objection to Petitioner’s Exhibit 6 is overruled.  While CMS correctly notes that the statement is not in the form of an affidavit, I find that the information contained therein is relevant and material to this case.  The evidence will be given the proper weight and consideration.

CMS also objected to Petitioner’s Exhibits 11-15, which are care plans and records pertaining to the care of R5 and R10, who were both residents at Epione.  CMS argues that the records are not material or relevant to Epione’s care of R2. CMS’s objections are overruled.  Petitioner’s Exhibits 1-15 are admitted into the record.  The exhibits will be given the proper weight and consideration.

Neither party requested to cross-examine the opposing party’s witnesses.  Therefore, CMS’s motion for summary judgment is moot and this case may be decided on the written record.

III. Issues

The issues are as follows:

1. Whether Petitioner was in substantial compliance with 42 C.F.R. § 483.25(b)(1)(i)-(ii) (Tag F686, s/s level J);
2. If it is determined that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(b)(1), whether CMS’s immediate jeopardy determination was clearly erroneous; and
3. If Petitioner was not in substantial compliance, whether a $22,320 per-day CMP beginning May 25, 2021 through June 2, 2021, and a CMP of $225 per-day for 18 days beginning June 3, 2021 through June 20, 2021, are reasonable.

IV. Jurisdiction

I have jurisdiction to hear and decide this case.  Social Security Act (Act) §§ 1128A(c)(2), 1819(h)(2)(B)(ii) (codified at 42 U.S.C. §§ 1320a-7a(c)(2), 1395i‑3(h)(2)(B)(ii)); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).

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V. Legal Authorities

The Act sets requirements for SNFs to participate in the Medicare program and authorizes the Secretary of Health & Human Services (Secretary) to promulgate regulations implementing those statutory provisions.  Act § 1819 (42 U.S.C. § 1395i-3).  The Secretary’s regulations are found at 42 C.F.R. part 483 and 488.

To participate in the Medicare program, a SNF must maintain substantial compliance with program requirements.  42 U.S.C. § 1395i-3(a)(3), (b)-(d); 42 C.F.R. pt. 483, subpt. B.  When CMS selects an enforcement remedy to impose on a 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); see also 42 U.S.C. § 1395i-3(h)(2)(B)(ii)(III)(bb).

CMS may impose a per-day CMP for the number of days a 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 January 17, 2020 and before November 15, 2021, and for deficiencies that occurred on or after November 2, 2015, the CMP amounts may range as follows:  $112 to $6,695 per day for less serious noncompliance; or $6,808 to $22,320 per day for noncompliance that poses immediate jeopardy to the health and safety of residents.2  45 C.F.R. § 102.3 (2020); 85 Fed. Reg. 2869, 2880 (Jan. 17, 2020); see 42 C.F.R. § 488.438(a)(1) (providing original CMP amounts before statutory inflation adjustments).

Depending on the nature of a facility’s noncompliance and the type of remedy imposed by CMS, a facility may also by operation of law lose its ability to offer or conduct a nurse aide training and competency evaluation program (NATCEP) for two years.  42 C.F.R. § 483.151(b)(2).  Pursuant to 42 C.F.R. § 483.151(b)(2) and (f), a state may not approve and must withdraw any prior approval of a NATCEP offered by a SNF or nursing facility that has been:  (1) subject to an extended or partial extended survey under sections 1819(g)(2)(B)(i) or 1919(g)(2)(B)(i) of the Act; (2) assessed a CMP of not less than $11,160 (45 C.F.R. § 102.3 (Table) (2020)); or (3) subject to termination of its participation agreement, a DPNA, or the appointment of temporary management.  Ineligibility or withdrawal of approval to conduct a NATCEP is mandatory if any of the conditions are satisfied; it is not a remedy that the state agency or CMS may decline to impose.  See 42 C.F.R. § 488.406.

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If CMS imposes a remedy based on a noncompliance determination, then the facility may request a hearing before an administrative law judge to determine whether there was a basis for the deficiency findings that led to the imposition of the remedy and whether the CMP imposed was reasonable.  Act §§ 1128A(c)(2) (42 C.F.R. § 1320a-7a(c)(2)), 1819(h)(2)(B)(ii) (42 U.S.C. § 1395i-3(h)(2)(B)(ii)); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).  However, the facility may not appeal CMS’s choice of remedies.  42 C.F.R. § 488.408(g)(2).

A facility may only challenge CMS’s determination as to the scope and severity of noncompliance if a successful challenge would affect the range of the CMP that may be imposed or impact the facility’s authority to conduct a NATCEP.  42 C.F.R. § 498.3(b)(14), (d)(10)(i).  CMS’s determination as to the level of noncompliance, including the finding of immediate jeopardy, “must be upheld unless it is clearly erroneous.”  42 C.F.R. § 498.60(c)(2); Woodstock Care Ctr., DAB No. 1726 at 9, 39 (2000), aff’d, 363 F.3d 583 (6th Cir. 2003).  Appellate decisions of the DAB have 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., Koester Pavilion, DAB No. 1750 (2000).

CMS must make a prima facie showing that the facility failed to comply substantially with federal participation requirements.  If this occurs, the facility must prove substantial compliance by a preponderance of the evidence in order to rebut CMS’s showing and to prevail.  Hillman Rehab. Ctr., DAB No. 1611 at 8 (1997), aff’d, No. Civ. A 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999); Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff’d, 129 F. App’x 181 (6th Cir. 2005); Emerald Oaks, DAB No. 1800 (2001); Cross Creek Health Care Ctr., DAB No. 1665 (1998).

VI. Findings of Fact

Resident 2 was a 92-year-old man admitted to Petitioner’s facility on December 1, 2016.  CMS Ex. 25.  R2 had several diagnoses, including, but not limited to, chronic obstructive pulmonary disease, heart failure, Stage 3 of chronic kidney disease, dementia, neuropathy, and osteoarthritis.  CMS Ex. 47 at 1.

R2 was assessed on December 2, 2016, and it was determined that he had the potential for the impairment of skin integrity.  CMS Ex. 20.  R2’s initial care plan called for a nurse aide to inspect his skin daily and report any changes to the nurse.  CMS Ex. 20.

An intervention was added to R2’s care plan on January 9, 2020, stating that the nurse aide was to provide barrier cream to R2’s peri-area as needed.  CMS Ex. 20.

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On August 13, 2020, R2 was assessed using the Braden Scale for Predicting Pressure Ulcer Risk (Braden Scale).  R2 scored a 17.  CMS Ex. 23.3

On or around August 31, 2020, Petitioner implemented a new electronic charting system.  However, R2’s care plan did not transfer into the new system.

From October 10, 2020 to November 23, 2020, Epione experienced a COVID-19 outbreak with 31 residents and 21 staff members testing positive for COVID-19.  P. Ex. 2 at 2.  R2 tested positive for COVID-19 on October 20, 2020.  P. Ex. 4 at 7; CMS Ex. 21 at 2.  R2’s care plan addressed treatment for his COVID-19 diagnosis, but not his susceptibility to pressure injuries.  CMS Ex. 21 at 2.

R2 was reassessed using the Braden Scale on November 6, 2020.  CMS Ex. 24.  R2 scored a 15 on the scale, which indicated that he was at risk for developing a pressure ulcer.  Id.  On November 10, 2020, a pressure injury measuring 3.0 cm in length x 0.4 cm in width x 0.1 cm in depth was found near R2’s upper gluteal crevice.4  An order for duoderm dressing was initiated and applied, and it was noted that R2 continued to use a gel cushion in his recliner.  CMS Ex. 22 at 1; P. Ex. 4 at 40.  Petitioner updated R2’s care plan on November 11, 2020 with the following interventions:  encourage resident to reposition from side to side while in bed with staff assistance; if a skin tear occurs, provide treatment per facility protocol and notify the physician and family; keep skin clean and dry, and use lotion on dry scaly skin; monitor/document location, size and treatment of skin tear; report abnormalities, failure to heal, signs and symptoms of infection, maceration, etc. to the physician; continue to use a gel cushion while sitting in recliner as tolerated; use APM [alternating pressure mattress] mattress.  CMS Ex. 21 at 26.

R2 was admitted to Southwest Health Hospital on November 12, 2020, due to facial swelling.  CMS Ex. 26 at 1.  The hospital noted that R2 had a “[l]arge $0.50 piece sized deep midline sacral ulcer with surrounding slough consistent with shearing of skin.”  CMS Ex. 26 at 23.  A green discharge was cultured, and the results showed moderate growth of Morganella morganii, heavy growth of Enterococcus faecalis, and moderate growth of Pseudomonas aeruginosa.  CMS Ex. 26 at 39, 41-44.  Under “Assessment,” the physician listed several diagnoses, including parotitis and “[p]ressure injury of sacral

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region, stage 3.”  CMS Ex. 26 at 25.  On November 17, 2020, R2 was discharged back to Epione.  The discharge summary noted the “[s]acral ulcer remains difficult with some sloughing surrounding the area as well.  Wound care will need to continue.”  CMS Ex. 26 at 14.  The summary included special instructions to continue daily wound care for the sacral ulcer.  CMS Ex. 26 at 16.  The hospital records show that R2 was repositioned every two hours and barrier cream was applied to the excoriated area.  P. Ex. 4 at 45.

Upon readmission to Epione, R2 was reassessed and scored 11 on the Braden Scale, indicating that he was at high risk for developing a pressure injury.  R2’s pressure injury was Stage III and measured 3.8 cm x 2.0 cm x. 1.8 cm.  CMS Exs. 27 at 2; 28.

A nursing note dated November 19, 2020, stated that R2 had a “[n]ew duoderm over stage III on coccyx crease and around his anus” with the top layer of skin missing in some areas.  According to the note, staff notified R2’s treating physician, Dr. Jeffrey White, of the skin around his anus.  CMS Ex. 22 at 5; P. Ex. 4 at 52.  On the same date,  Dr. White entered a treatment order directing staff to “cleanse wound with wound cleanser, apply skin prep to peri wound, place calcium alginate to wound beds and cover with a duoderm.  One time a day every 3 day(s) for wound/dressing change.”  CMS Ex. 31 at 2.

A nursing note dated November 21, 2020, called for an assist of two people “to provide peri care inc. [including], of soft stool, frequent replacement of dressing to coccyx area, reposition resident side to side assist of 2.”  P. Ex. 4 at 58.  On November 23, 2020, it was noted that R2 was taking antibiotics as ordered and the duoderm was intact to his buttocks.  P. Ex. 4 at 65.

The next note regarding R2’s pressure injury was a skin/wound note entered on December 10, 2020, which noted “[w]ound to sacrum changed as ordered, tolerated well.  Wound edges distinct and boggy to distal edges.  Wound bed is moist and red with white slough.  Moderate amount of serosanguinous on soiled dressing noted.”  The wound was measured at 4 cm L x 1.6 cm W x 1.5 cm D.  CMS Ex. 22 at 10.  Dr. White examined R2 on December 11, 2020, and noted that R2 had diminished capacity and difficulty recovering from COVID-19.  CMS Ex. 32.  R2’s loose stools ended on or about December 14, 2020.  P. Ex. 4 at 101.

Another wound assessment and measurement was taken on December 16, 2020, noting that:

[t]he open area to the coccyx measures:  the open [sic] to the wound is 3.6 c.m. by 2.2 c.m.  There is tunneling at 0300 with a depth of 2.8 c.m. and 0700 to 0900 with a depth of 1.5 c.m.  The wound edges are defined and firm.  The center depth of the wound is 2.2 c.m.  The wound bed is 100% slough.  No

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s/sx [signs/symptoms] of infection noted.  The peri skin is dry and intact.  Wound cleansed, packed, and covered.  MD updated on wound status and orders obtained.  Care plan updated.

CMS Ex. 22 at 11; P. Ex. 4 at 102.  R2 was provided with a Pro Elite alternating pressure mattress on December 18, 2020.  CMS Ex. 45 at 1-2.

Ten days later, on December 26, 2020, a nurse noted, “[w]ound care provided to pressure ulcer on coccyx.  Area cleansed, packed with ointment gauze and dressed with a foam dressing.”  P. Ex. 4 at 110.  A nursing note dated December 27, 2020, stated that R2’s dressing to his coccyx was changed without incident that morning and that R2 tolerated the procedure well.  CMS Ex. 22 at 13.  In a skin/wound note date January 1, 2021, a nurse documented:

Wound care performed as ordered, tolerated well.  Wound bed has significant slough noted and copious amount of yellow/green drainage.  Foul odor noted.  Resident remains afebrile at this time and states he has no pain.  Pervious [sic] dressing saturated.  PCP aware.

CMS Ex. 22 at 14.

The next substantive note regarding R2’s pressure injury was dated January 8, 2021, when R2 was assessed by Dr. White, who noted that the pressure injury was infected, and the sacral ulcer was quite large with “stage IV findings and a gray membrane or pseudomembrane noted with significant malodor and discharge.”  CMS Ex. 35.  A care plan for R2 was initiated on the same date, and an intervention was put in place to “[c]ontinue to follow all wound care orders.”  CMS Ex. 21 at 15.  No wound measurements were documented on this date.  Dr. White noted that that R2’s prognosis was “quite grave” and noted no other changes.  CMS Ex. 35.

A nursing note dated January 18, 2021, states “[d]ressing to coccyx discovered dislodged at this time.  [R2] refuses to have treatment and dressing change at this time.”  P. Ex. 4 at 136.  A nursing note later that day stated that there was still a large amount of wound drainage; the old dressing was removed, and the wound was cleansed and redressed per orders.  R2 was repositioned every two hours to keep him off his bottom.  P. Ex. 4 at 138.  That night, a nurse documented that R2 continued to receive antibiotics for his coccyx wound, his dressing was “c/d/i” [clean, dry, intact] with no drainage visible,” and he was positioned per facility policy to evenly distribute his body weight every two hours.  The nurse noted that R2 had an appointment at a wound clinic later that week.  P. Ex. 4 at 139.

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R2 was again assessed for pressure injury risk on January 28, 2021.  R2 scored 15 on the Braden Scale, indicating he was at risk for developing pressure ulcers.  CMS Ex. 39.

According to the January 8, 2021 care plan, the following intervention was initiated:  “Cleanse wound with Dakins pack with sponge and cover with clear dressing bridge to hip and apply wound vac [every] Mon, Wed, Friday[.]”  CMS Ex. 21 at 15.

On January 22, 2021, R2 began receiving wound care through the Wound Care Clinic at Finley Hospital.  CMS Ex. 37 at 1-2; P. Ex. 2 at 3.  Dr. White examined R2 on February 12, 2021, and noted that there was some improvement in the wound, though the wound had a high risk of not healing.  Dr. White noted that R2 had an “excellent air mattress.”  CMS Ex. 40; P. Ex. 9.  On the same date, in a “Skin Only Evaluation” report, it was also noted that R2’s pressure ulcer at his coccyx was unstageable and  tunnelling was present.  The area was cleansed with Dakins and repacked with foam and wound vac treatment was applied.  CMS Ex. 41 at 2; P. Ex. 4 at 158.  The wound measured 2.5 cm in length x 2 cm in width and had an odor.  CMS Ex. 41 at 1-2; P. Ex. 4 at 158.

On February 17, 2021, R2’s wound was noted to have had a bad odor when the wound vac dressing was changed the previous day.  P. Ex. 4 at 161.  The dressing on the wound was intact for wound vac on February 20, 21, and 23.  P. Ex. 4 at 167, 170, 176.  On February 24, 2021, R2’s pressure injury was still Stage IV, he remained on antibiotics, and a nurse noted “wound vac placed.”  P. Ex. 4 at 179, 180.  A nursing note dated February 26, 2021, documented that “wound vac changed as ordered.”  P. Ex. 4 at 186.  Improvement was noticed in R2’s wound as of March 3, 2021.  P. Ex. 4 at 189.

On March 12, 2021, Dr. White examined R2 and noted that his “rather severe sacral ulcer is actually healing.”  P. Ex. 10.  Dr. White further noted that R2’s “[l]ower extremity ulcer is observed and has significantly reduced in size . . . still a stage IV ulcer at this time, but I see no pseudomembrane which has been excised and/or treated with antibiotic and dressings changes in the Wound Clinic with good results.”  P. Ex. 10.

On April 14, 2021, another Braden Scale assessment was conducted on R2.  The score increased to 16, which again indicated that R2 was at risk for pressure ulcers.  CMS Ex. 43.

On April 16, 2021, Petitioner’s staff conducted a skin evaluation.  It was determined that R2’s pressure ulcer was “Stage IV:  Full thickness tissue loss” and measured 1.8 cm deep.  No length or width was recorded.  An odor was noted along with tunneling.  Staff contacted R2’s physician, Dr. White, and updated him on the pressure ulcer measurements.  P. Ex. 4 at 248; CMS Ex. 44.  R2 began receiving hospice care on April 16, 2021, and died on April 24, 2021.  P. Br. at 2.

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On June 3, 2021, Epione was notified that an immediate jeopardy situation existed, which began on January 8, 2021, and that the immediate jeopardy was removed on June 3, 2021, after it completed several corrective measures, including immediately educating all nursing staff prior to their next working shift, on completing pressure injury assessments, measurements, care plan updates, and appropriate pressure injury interventions.  CMS Ex. 9 at 2, 12-13.

A revisit survey was conducted on July 7, 2021, and it was found that Epione was in substantial compliance with the requirements for long term care facilities effective June 21, 2021.  CMS Ex. 4.

VII. Analysis and Conclusions of Law

1. Epione Pavilion was not in substantial compliance with 42 C.F.R. § 483.25(b)(1)(i)-(ii) (Tag F686) because it failed to ensure that R2 received appropriate care to prevent pressure ulcers and, after he developed a pressure ulcer, failed to provide necessary treatment and services to promote healing and prevent infection consistent with professional standards.

Under the Act 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. § 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 their 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 they receive 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 so, and the resident still develops sores, then there is 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, 19 (2010), aff’d, 405 Fed. App’x 820 (5th Cir. 2010); Koester Pavilion, DAB No. 1750 at 32 (2000).

Upon entering the facility in December 2016, Resident 2 was assessed, and it was determined that he had the potential for the impairment of skin integrity.  CMS Ex. 20.  The initial care plan called for a nurse aide to check R2’s skin daily and report any changes to the nurse.  CMS Ex. 20.  Despite knowing that R2 was susceptible to

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developing pressure ulcers, Petitioner did not have a care plan in place that addressed R2’s risk for skin breakdown from around August 31, 2020, until after R2’s pressure injury developed.  CMS Ex. 9 at 2; CMS Ex. 21.  On November 10, 2020, several weeks after R2 was diagnosed with COVID-19, a registered nurse at the facility noted that Resident 2 had a slit-like opening to his upper gluteal crevice, measuring 3.0 cm in length x 0.4 cm in width x 0.1 cm in depth.  CMS Ex. 22 at 1.  A care plan was developed after the nurse discovered R2’s pressure injury, despite Petitioner being repeatedly identified as a resident at risk or at high risk for developing pressure ulcers.  CMS Ex. 9 at 5; CMS Ex. 21 at 26.

According to the SOM guidelines, “unavoidable” means that “the resident developed a pressure ulcer/injury even though the facility had evaluated the resident’s clinical condition and risk factors; defined and implemented interventions that are consistent with resident needs, goals, and professional standards of practice; monitored and evaluated the impact of the interventions; and revised the approaches as appropriate.5  P. Ex. 7 at 2.  The Board has ruled that a facility “cannot claim unavoidability unless it first shows that it furnished all necessary treatment and services.”  Heritage House of Marshall Health & Rehab., DAB No. 3035 at 12 (2021).

Epione argues that due to R2’s comorbidities and his COVID-19 diagnosis, the pressure injury and the ensuing infection were unavoidable, and that CMS failed to consider the impact of the COVID-19 outbreak at the facility  P. Br. at 6, 12.  Petitioner’s Director of Nursing (DON) claims that the facility took “aggressive efforts” to treat R2’s pressure injury.  P. Ex. 2 at 4.  Petitioner also claims that R2’s wound was regularly assessed; however, those assessments are not documented in the record.  It is difficult to determine if the alleged “aggressive efforts” were effective, or to determine that adequate care was provided to R2’s pressure injury when there is inconsistent documentation as to the treatment and the impact of the interventions.  As of December 10, 2020, R2’s pressure injury measured 4.0 cm in length x 1.6 cm in width x 1.5 cm in depth.  CMS Ex. 22 at 10.  On December 16, 2020, R2’s wound measured 3.6 cm x 2.2 cm, and no sign of infection was noted.  P. Ex. 4 at 102.  The next substantive note regarding R2’s pressure injury was dated January 8, 2021, where it was noted that the pressure injury was Stage IV and infected.  CMS Ex 35.  There is no record of what, if any, treatment was provided from November 26, 2020 – December 10, 2020, and it casts doubts on Petitioner’s alleged aggressive efforts.  The DON acknowledges the gaps in the record, stating, “[d]espite any gaps in documentation in R2’s record, R2’s wound was cleansed and assessed numerous

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times a day during the provision of peri cares.”  P. Ex. 2 at 2.  However, the Board has generally been unwilling to accept that treatments that are not documented have nevertheless been performed.  River City Care Ctr., DAB No. 2567 (2015).

Petitioner argues that it provided R2 with care consistent with professional standards “at the time of the COVID-19 crisis and a facility COVID-19 outbreak.”  P. Br. at 7.  In support, Petitioner cites to an article issued by the U.S. Department of Health and Human Services in October 2020 entitled, “COVID-19 Intensifies Nursing Home Workforce Challenges,” discussing the effects of COVID-19 on nursing homes.  P. Br. at 10-12 (citing P. Ex. 5).  However, for better or for worse, the professional standards for skilled nursing facilities pertaining to the care and treatment of pressure ulcers were not changed due to the COVID-19 pandemic.  While I acknowledge and sympathize with the challenges faced by medical professionals and SNFs during the COVID-19 pandemic, Petitioner was still expected to have a care plan in place and to care for R2’s pressure wound consistent with the professional standards.  Additionally, Epione experienced a COVID-19 outbreak from October-November 2020.  This does not explain why R2 did not have a care plan addressing his susceptibility to developing pressure ulcers in place prior to the outbreak and why measurements were inconsistently taken and documented long after the COVID-19 outbreak at the facility ended.

Petitioner also provided an article titled, “Unavoidable Pressure Injury during COVID-19 Pandemic:  A Position Paper from the National Pressure Injury Advisory Panel,” which states that “the preventive measures possible in pre-COVID-19 times may not have been feasible in the middle of the COVID-19 crisis.”  P. Ex. 3 at 5.  The article goes on to state that the “demand for appropriate equipment” and “the skin and wound care products required may have been difficult to obtain” and that all extrinsic and intrinsic factors should be considered when determining the avoidability of a pressure injury that developed during the COVID-19 crisis.  Id.  In this case, Petitioner has not alleged a shortage of equipment to treat pressure injuries, nor that it had difficulty obtaining skin and wound care products.  While Petitioner does mention that several staff members contracted COVID-19, it does not explain the continued lapses in documentation and treatment for R2’s pressure injury.  Petitioner argues that CMS failed to consider the totality of the circumstances when determining noncompliance and that CMS failed to acknowledge the steps that were taken to aid R2, such as providing a bariatric air mattress, and later providing a more advanced pressure-reducing air mattress prior to his COVID-19 infection.  P. Br. at 6.  Petitioner also argues that R2’s pressure injury developed and worsened only as a result of his other comorbidities and his COVID-19 infection.  P. Br. at 8, 12.  However, Petitioner has not provided any evidence to support this claim.  Even if the wound developed as a result of other co-morbidities, Petitioner still had the responsibility to properly care for the wound.  The evidence shows there are large gaps in the records pertaining to the treatment of R2’s pressure ulcer.  While Petitioner touts improvements in R2’s pressure injury, it fails to acknowledge that the wound festered for months and became infected, progressing to a Stage IV pressure

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injury, before showing any signs of improvement.  Dr. White surmises that the “wound care was adequate at the nursing home level” and the wound showed improvement once R2 received treatment through the wound care clinic at Finley Hospital.  P. Ex. 6.  However, Dr. White did not address the lapses in documentation or the lack of a care plan to address R2’s susceptibility for pressure injuries, nor did he state whether R2’s pressure injury was avoidable, nor define what he deems as adequate care, which are all issues central to this case.  On the other hand, Dr. Berlowitz, CMS’s expert witness, concluded that R2’s pressure injury was avoidable, based on a review of the record and based on his experience.  CMS Ex. 62 at 6.  I find credible and convincing Dr. Berlowitz’s testimony, which notes that even if R2’s wound was unavoidable, Epione failed to provide treatment and services consistent with professional standards to promote its healing.  Id.  “An ALJ may discount a treating physician’s testimony when it is unpersuasive, internally inconsistent, or not ‘consistent with the weight of other substantial evidence.’” Autumn Ridge Rehab. Ctr., DAB No. 2467 at 15 (2012) (quoting Golden Living Ctr. - Frankfort, DAB No. 2296 at 7 (2009)).  Here, I find Dr. White’s statements to be unpersuasive because it is inconsistent with the weight of the evidence in the record.

Lastly, the record shows that R2 experienced loose stools as a side effect of the antibiotics that he was prescribed.  P. Ex. 2 at 2.  Petitioner argues that the diarrhea prevented nursing staff from measuring R2’s wound and it interfered with the treatment of the pressure injury.  P. Br. at 8.  The DON stated that the prolonged diarrhea resulted in frequent dressing changes, which allowed for more frequent monitoring of R2’s wound, but slough developed and hindered the ability to take accurate measurements.  P. Ex. 2 at 3.  However, the record does not show that staff attempted to take measurements but were unable to do so due to R2’s loose stools.  The records show large gaps between measurements, with no explanation for the gaps in the record.  Additionally, the lack of measurements in the records continued long after R2’s diarrhea ended on or around December 14, 2020.  P. Ex. 4 at 101.

Epione’s Policy and Procedure on Pressure Injury Prevention and Managing Skin Integrity states that after an abnormal skin finding a wound care nurse or designee will conduct a weekly skin evaluation, update the primary care physician with any changes, update the Care Plan with any new interventions, and update the resident’s representative as indicated.  CMS Ex. 16 at 2.  The policy also states that staff nurses are to follow through with the interventions implemented for the prevention and treatment of skin breakdown.  CMS Ex. 16 at 2.  Unfortunately, these steps were not taken with R2.  The Board has held that the requirements under section 483.25 “obligate the [facility] to furnish the care and services set forth in a resident’s care plan, to implement doctors’ orders, to monitor and document the resident’s condition, and . . . to follow its own resident care policies.”  Heritage House of Marshall Health, DAB No. 3035 at 10.  Additionally, the Board (and ALJ) may “rely on a facility policy as evidence of the provider's own judgment as to what must be done to attain or maintain its residents’ highest practicable

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physical, mental and psychosocial well-being, as required by section 483.25.”  Id. at 10.  Petitioner did not adhere to its own policy.

While acknowledging that R2 was less mobile and had a decreased appetite due to the effects of COVID-19, the evidence shows that R2’s pressure injury was avoidable.  Epione did not have a care plan in place to address R2’s risk for developing pressure injuries, prior to his COVID-19 diagnosis.  Having a care plan to address this issue for R2 was critical, especially given the impact of COVID-19, his predisposition to pressure wounds, and his existing comorbidities.  Additionally, the lack of documentation regarding the treatment of R2’s wound brings into question what preventative and treatment measures were actually provided.  The evidence establishes that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(b)(1)(i)-(ii) (Tag F686) because it failed to provide care to R2 consistent with professional standards.

2. CMS’s immediate jeopardy determination was not clearly erroneous. 

CMS alleges that Petitioner’s violation of 42 C.F.R. § 483.25(b)(1)(i)-(ii) constituted immediate jeopardy to resident health and safety.  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).  CMS’s determination as to the level of a facility’s substantial noncompliance (which includes an immediate jeopardy finding) must be upheld unless it is “clearly erroneous.”  42 C.F.R. § 498.60(c).  The “clearly erroneous” standard imposes on facilities a heavy burden to overcome a finding of immediate jeopardy.  Appellate panels of the DAB have 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) (citing Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004)), aff’d, 174 F. App’x 932 (6th Cir. 2006).

The state agency determined that immediate jeopardy existed beginning January 8, 2021, when R2’s physician determined that R2’s wound had progressed to stage IV.  CMS Ex. 60 at 3.  The decision was based on three factors:  Epione’s failure to complete weekly pressure injury assessment and wound measurements; the noncompliance resulted in serious injury and serious harm to R2; and immediate action was necessary to correct the noncompliance.  CMS Ex. 60 at 2.  The state agency informed Petitioner of the immediate jeopardy via telephone on June 3, 2021.  CMS Ex. 60 at 3.

Petitioner argues that after R2 developed his pressure wound and after his passing, there was no need for immediate action beyond what was taken by Epione.  P. Br. at 23.  Petitioner included records for patients identified as R5 and R10 who also suffered from pressure injuries and argues that those pressure injuries were properly attended to by

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Epione.  P. Br. at 20-21.  Epione also argues that they had baseline processes and procedures in place to protect residents from pressure wound injuries.  P. Br. at 22.  Though it is undisputed that Epione had a policy in place regarding pressure injuries, its staff failed to follow it, which resulted in R2’s pressure injury progressing to Stage IV and becoming infected.  Despite Epione’s argument of two other residents who may have been properly treated, there was a need for immediate action to prevent other residents from suffering the same harm as R2.

Given the evidence of the likelihood of serious harm and actual serious harm suffered by R2, the record supports CMS’s immediate jeopardy determination.  CMS’s determination of immediate jeopardy is not clearly erroneous.

3. The CMP amounts imposed, $22,320 per day from May 25, 2021 through June 2, 2021, and $225 per day from June 3, 2021 through June 20, 2021 are reasonable.

Reasonableness of CMPs

In this case, CMS imposed a $22,320 per-day CMP for nine days from May 25, 2021 through June 2, 2021, and a $225 per-day CMP for 18 days from June 3, 2021 through June 20, 2021.  CMS Ex. 6.  Epione has challenged both the duration of the non-compliance periods and the amount of the CMP.

In determining whether the amounts of CMPs are reasonable, I must apply the following factors which are listed in 42 C.F.R. § 488.438(f):  1) the facility’s history of noncompliance; 2) the facility’s 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 42 C.F.R. §§ 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) and (3); Alexandria Place,DAB No. 2245 at 27 (2009); Kenton Healthcare, LLC,DAB No. 2186 at 28-29 (2008).  The Board has explained that “there is a presumption that CMS has considered the regulatory factors in setting the

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amount of the CMP and that those factors support the CMP amount imposed by CMS.  Unless a facility contends that a particular regulatory factor does not support that CMP amount, the ALJ must sustain it.”  Coquina Ctr., DAB No. 1860 at 32 (2002) (emphasis added).  Thus, the burden is not on CMS to explain its decision-making process or to explain the relative weights assigned to each deficiency to support the CMP amounts imposed.  Once the facility contends that a regulatory factor does not support the CMP amount, CMS must then produce evidence as to that factor.  Id.

CMS argues that Petitioner has a history of noncompliance, though none of its prior deficiencies have been cited as immediate jeopardy violations.  CMS Br. at 21; CMS Ex. 8.  The evidence shows that Petitioner was cited for noncompliance in the following survey cycles:  October 2018 (highest s/s level cited was D), February 2019 (highest s/s level cited was F), June 2019 (highest s/s levels cited were G and D),  March 2020 (highest s/s levels cited were D and F), and March 2021 (highest s/s level cited was D).  CMS Ex. 8.  Petitioner has not disputed this evidence.  Therefore, CMS has proven that Petitioner has a history of noncompliance.

Petitioner has not provided information regarding the facility’s financial condition.  The state agency stated that Petitioner reported assets of $79,282,346 with liabilities of $13,310,609.  CMS Ex. 2.  However, Petitioner did not argue that its financial condition necessitates a reduction of the CMP.  Therefore, this factor does not require further consideration.

In determining whether a CMP amount is reasonable, I must also consider culpability, which the applicable regulation defines to include “neglect, indifference, or disregard for resident care, comfort, or safety.”  42 C.F.R. § 488.438(f)(4).  I do not believe Petitioner intended neglect, indifference, or disregard for its residents.  Nevertheless, Petitioner’s culpability is significant.  As stated, Petitioner failed to have a plan in place for an elderly resident identified as being susceptible to pressure injuries.  Petitioner also failed to document and measure R2’s pressure injury weekly, which resulted in the wound progressing to stage IV and ultimately becoming infected.

The $22,320 per-day CMP for the facility’s noncompliance with the requirement to treat pressure wounds is at the upper limit of the range of immediate jeopardy CMP amounts ($6,808 to $22,320).  85 Fed. Reg. at 2880.  As discussed above, the facility’s noncompliance here was very serious.  Despite R2’s wound becoming infected, staff routinely failed to assess and measure the wound at every shift as required by Epione’s policy, and for a substantial period there was no care plan in place for R2 which addressed his susceptibility to skin breakdown.  The facility was also very culpable because assessing and measuring R2’s wound every shift was part of Epione’s policy and staff failed to carry out those directives.  These factors more than support the $204,930 CMP.

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Duration of the Noncompliance

Petitioner also challenges the duration of the noncompliance.  P. Br. at 23.  Specifically, Petitioner argues that the dates for which CMS imposed a CMP are after R2 passed away.  P. Br. at 24.  The survey in question was completed on June 8, 2021, in response to a complaint. The immediate jeopardy violation was removed effective June 3, 2021, when Epione provided CMS with a list of tasks that it would complete to abate the immediate jeopardy.  CMS Ex. 60 at 3.  A surveyor returned to Epione on June 8, 2021, to confirm that steps were taken to abate the immediate jeopardy.  CMS Ex. 60 at 4.6

In general, when a facility has been found not to be in substantial compliance with the participation requirements, the facility must submit a plan of correction (POC) that is acceptable to CMS or the state agency.  42 C.F.R. §§ 488.402(d), 488.408(f).  If CMS accepts a noncompliant facility’s POC, the facility must then timely implement all the steps that it identified in the POC as necessary to correct the cited problems.  Cal Turner Extended Care Pavilion, DAB No. 2030 at 18-19 (2006); see also Meridian Nursing Ctr., DAB No. 2265 at 20-21 (2009); Lake Mary Health Care, DAB No. 2081 at 29 (2007).  A noncompliant facility “is not considered to be [back] in substantial compliance until a determination has been made, through a revisit survey or based on ‘credible written evidence’ that ‘CMS or the State can verify without an on-site visit,’ that the facility returned to substantial compliance.”  Omni Manor Nursing Home, DAB No. 2431 at 6 (2011) (citing or quoting 42 C.F.R. § 488.454(a)(1) and Oceanside Nursing & Rehab. Ctr., DAB No. 2382 at 20 (2011)).  The Board has previously held that the noncompliance found during a survey is “presumed to continue until the facility demonstrates that it has achieved substantial compliance.”  Taos Living Ctr., DAB No. 2293 at 20 (2009).  Here, Epione submitted a plan of correction on June 16, 2021, indicating that the measures listed in the POC would be completed by June 21, 2021.  CMS Ex. 48.  A verification survey was conducted on July 7, 2021, and it was determined that Epione was back in substantial compliance.  Epione has not proven that it returned to substantial compliance prior to the revisit survey.

Petitioner argues that the noncompliance ended when R2 passed away on April 24, 2021.  The Board has previously rejected similar arguments and has repeatedly found that discharging an individual (resident or employee) who is at the center of an immediate jeopardy finding does not alleviate the immediate jeopardy.  Rosewood Care Ctr. of Rockford, DAB No. 2466 at 7 (2012); Florence Park, DAB No. 1931; Sheridan Health Care Ctr., DAB No. 2178 at 43-44 (2008).

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The regulations and prior Board decisions also make clear that a facility’s “noncompliance is deemed to be corrected or removed only when the incidents of noncompliance have ceased, and the facility has implemented appropriate measures to ensure that similar incidents will not recur.”  Florence Park, DAB No. 1931 at 30 (bolded emphasis added); see also Oceanside, DAB No. 2382 at 20.  Moreover, the facility “bears the burden of showing that it returned to substantial compliance on a date earlier than that determined by CMS,” and the Board “has rejected the idea that CMS must establish a lack of substantial compliance during each day in which a remedy remains in effect.”  Owensboro Place & Rehab. Ctr., DAB No. 2397 at 12 (2011).

VIII. Conclusion

Epione Pavilion was not in substantial compliance with the participation requirements at 42 C.F.R. § 483.25(b)(1) (Tag F686).  CMS’s determination that Epione’s noncompliance posed immediate jeopardy to resident health and safety was not clearly erroneous.  There is a basis for the imposed remedies and the penalty amounts imposed are reasonable.