The Palace Rehabilitation and Care Center, DAB CR6802 (2025)

DECISION

Petitioner, The Palace Rehabilitation and Care Center, is a New Jersey-based long-term care facility that participates in the Medicare program.  Based on a survey completed on January 31, 2022, the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with multiple program requirements, including 42 C.F.R. § 483.25(b)(1), which is a quality-of-care regulation that addresses pressure ulcers.  Based on that deficiency, CMS imposed a per-instance civil money penalty (CMP) of $12,515.

Petitioner appealed, and CMS moves for summary judgment, which Petitioner opposes.  For the reasons explained below, I grant CMS’s motion.  The undisputed evidence establishes that the facility was not in substantial compliance with section 483.25(b)(1) and that the penalty imposed is reasonable.

I.     BACKGROUND

The Social Security Act (Act) sets forth requirements for nursing facilities to participate in the Medicare program and authorizes the Secretary of Health and Human Services

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(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.  To participate in the Medicare program, a nursing facility must maintain substantial compliance with program requirements.  To be in substantial compliance, a facility’s deficiencies may pose no greater risk to resident health and safety than “the potential for causing minimal harm.”  42 C.F.R. § 488.301.

The Secretary contracts with state survey agencies to survey skilled nursing facilities to determine whether they are in substantial compliance.  Act § 1864, 42 U.S.C. § 1395aa; 42 C.F.R. § 488.20.  Each facility must be surveyed annually, with no more than 15 months elapsing between surveys, and must be surveyed more often, if necessary to ensure that identified deficiencies are corrected.  Act § 1819(g)(2)(A), 42 U.S.C. § 1395i-3(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308.  The state agency must also investigate all complaints.  Act § 1819(g)(4), 42 U.S.C. § 1395i-3(g)(4).

Here, surveyors from the New Jersey State Department of Health, Office of Long-Term Care (state agency), conducted a COVID-19 Focused Infection Control survey and investigated a complaint.  CMS Ex. 1 at 1.  Based on the state agency’s findings, CMS determined that the facility was not in substantial compliance with 42 C.F.R. § 483.25(b)(1) (Tag F686) (quality of care – treatment/services to prevent/heal pressure ulcers), cited at scope and severity level G (isolated instance of actual harm that is not immediate jeopardy).  Id. at 23; CMS Ex. 3.  Based on the deficiency, CMS imposed a per-instance CMP of $12,515.  CMS Ex. 3 at 1.

Petitioner appealed, and the case was assigned to Administrative Law Judge (ALJ) Leslie C. Rogall and later reassigned to the undersigned.  Consistent with ALJ Rogall’s Standing Pre-Hearing Order, CMS filed a Pre-Hearing Brief and Motion for Summary Judgment (CMS Br.) with 14 exhibits (CMS Exs. 1-14).  Petitioner filed its Pre-Hearing Brief and Opposition to Respondent’s Motion for Summary Judgment (P. Br.) with 15 exhibits (P. Exs. 1-15).  Petitioner also filed its General Objections to Respondent’s Pre-Hearing Brief, Witnesses and Exhibits (P. Objections).  CMS filed a Reply Brief (CMS Reply), which also contained its response to Petitioner’s objections.

Petitioner objects to my admitting CMS Ex. 12, the written direct testimony of Surveyor T.R., arguing that she has no personal knowledge of the resident at issue, R1, that her expert testimony is flawed and unreliable, and that she cannot opine on the facility’s internal business records as she is not the custodian of the records.  P. Objections at 1-3.  Petitioner also objects to the admission of CMS Ex. 2, Plan of Correction; CMS Ex. 4, AEM Nursing Home Enforcement History; CMS Ex. 7, Petitioner Pressure Ulcer Policy; CMS Ex. 13, nurse aide training and competency evaluation program (NATCEP) Reporting Sheet; and CMS Ex. 14, Chart of Resident’s Wound and Chart of Missed Treatments.  Id. at 3-6.  Petitioner argues the proposed exhibits are irrelevant, unreliable and/or not properly authenticated.  Id.

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I consider the proffered evidence to determine whether it creates a material fact in dispute but need not admit the exhibits into the record.  Lilia Gorovits, M.D., P.C., DAB No. 2985 at 3 n.4 (2020), aff’d sub nom. Gorovits v. Becerra, No. 20-1850, 2021 WL 1962903 (E.D. Pa. May 17, 2021); Ill. Knights Templar Home, DAB No. 2274 at 6-7 (2009) (holding that an ALJ must review all proposed exhibits submitted in support of or in opposition to a motion for summary judgment; the ALJ is not required to admit those exhibits into the record).  The exhibits are “properly treated as an offer of proof,” to be evaluated, as necessary to determine whether a genuine issue of material fact exists.  Ill. Knights Templar Home, DAB No. 2274 at 6.

II.     ISSUES

As a threshold matter, I consider whether summary judgment is appropriate.

On the merits, the issues before me are:

• Whether the facility was in substantial compliance with 42 C.F.R. § 483.25(b)(1); and
• If the facility was not in substantial compliance with § 483.25(b)(1), is the $12,515 per-instance CMP reasonable?

III.     DISCUSSION

Summary judgment is appropriate if a case presents no genuine issue of material fact, and the moving party is entitled to judgment as a matter of law.  Bartley Healthcare Nursing & Rehab., DAB No. 2539 at 3 (2013) (citing Celotex Corp. v. Catrett, 477 U.S. 317, 322-25 (1986)); Ill. Knights Templar Home, DAB No. 2274 at 3-4.

The moving party may show the absence of a genuine factual dispute by presenting evidence so one-sided that it must prevail as a matter of law or by showing that the non-moving party has presented no evidence “sufficient to establish the existence of an element essential to [that party’s] case, and on which [that party] will bear the burden of proof at trial.”  Livingston Care Ctr. v. U.S. Dep’t of Health & Hum. Servs., 388 F.3d 168, 173 (6th Cir. 2004) (quoting Celotex Corp., 477 U.S. at 322).  To avoid summary judgment, the non-moving party must then act affirmatively by tendering evidence of specific facts showing that a dispute exists.  Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 586 n.11 (1986); see also Vandalia Park, DAB No. 1939 (2004); Livingston Care Ctr., DAB No. 1871 (2003).  In doing so, the non-moving party must show more than “some metaphysical doubt as to the material facts.”  W. Tex. LTC Partners, Inc., DAB No. 2652 at 6 (2015), aff’d., W. Tex. LTC Partners, Inc. v. U.S. Dep’t of Health & Hum. Servs., 843 F.3d 1043 (5th Cir. 2016).

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In examining the evidence for purposes of determining the appropriateness of summary judgment, I must draw all reasonable inferences in the light most favorable to the non-moving party.  Livingston Care Ctr., 388 F.3d at 172; see also Brightview Care Ctr., DAB No. 2132 at 10 (2007) (entry of summary judgment upheld where inferences and views of non-moving party are not reasonable).  However, drawing factual inferences in the light most favorable to the non-moving party does not require that I accept the non-moving party’s legal conclusions.  W. Tex. LTC Partners, Inc., DAB No. 2652 at 6-7, 14-15; Cf. Guardian Health Care Ctr., DAB No. 1943 at 11 (2004) (“A dispute over the conclusion to be drawn from applying relevant legal criteria to undisputed facts does not preclude summary judgment if the record is sufficiently developed and there is only one reasonable conclusion that can be drawn from those facts.”).

Here, CMS has come forward with evidence, primarily the facility’s records for R1, establishing facts showing that the facility was not in substantial compliance with § 483.25(b)(1).  More specifically, R1 entered Petitioner’s facility with a pink area on her sacrum.  Within a month, the pink area progressed to an open wound and further deteriorated to a stage 4 pressure ulcer, for which R1 required hospitalization for treatment.  After R1’s readmission to the facility from the hospital, the stage 4 pressure ulcer remained and became infected requiring intravenous (IV) antibiotics.

For its part, Petitioner does not dispute these facts.  Instead, Petitioner contends that it complied with the regulatory requirements by taking all necessary precautions to promote the wound’s healing and to prevent infection, but the deterioration was unavoidable.  To support its contentions, Petitioner proffers additional medical documents, including its admission assessment, physician orders, and wound care consultant records, several staff affidavits, and an expert report.  I have drawn all reasonable inferences in Petitioner’s favor based on all the evidence submitted.  I find that the undisputed evidence establishes that Petitioner was not in substantial compliance with Medicare program requirements because it failed to take all necessary precautions to promote the healing and prevent infection of the resident’s pressure ulcer.

1. CMS is entitled to summary judgment because the facility did not take all necessary precautions to promote healing and prevent infection of a pressure ulcer, which was present at the time of R1’s admission.  This deficiency put the facility out of substantial compliance with 42 C.F.R. § 483.25(b)(1).

Program requirement.  42 C.F.R. § 483.25(b)(1), the regulatory subsection concerning pressure ulcer prevention and treatment, is a quality-of-care requirement.  The quality-of-care regulation broadly demands that “the facility must ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the resident’s choices . . . .”  42 C.F.R. § 483.25.  The regulatory regime “imposes on facilities an affirmative duty designed to

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achieve favorable outcomes to the highest practicable degree.” Windsor Health Care Ctr., DAB No. 1902 at 16-17 (2003), aff’d, Windsor Health Care Ctr. v. Leavitt, 127 F. App’x 843 (6th Cir. 2005).  The facility must take “reasonable steps” and “practicable measures to achieve that regulatory end.”  Clermont Nursing & Convalescent Ctr., DAB No. 1923 at 21 (2004), aff’d, Clermont Nursing & Convalescent Ctr. v. Leavitt, 142 F. App’x 900 (6th Cir. 2005).

The quality-of-care regulation at 42 C.F.R. § 483.25(b), Skin integrity provides:

(1) Pressure ulcers.  Based on the comprehensive assessment of a resident, the facility must ensure that -

(i) A resident receives care, consistent with professional standards of practice, to prevent pressure ulcers and does not develop pressure ulcers unless the individual’s clinical condition demonstrates that they were unavoidable; and

(ii) A resident with pressure ulcers receives necessary treatment and services, consistent with professional standards of practice, to promote healing, prevent infection and prevent new ulcers from developing.

42 C.F.R. § 483.25(b).

In assessing the facility’s compliance with this requirement, the relevant question is whether the facility took all necessary precautions to promote healing, prevent infection, and prevent new sores from developing.  If it did so, and the resident develops or existing sores worsen anyway, I could find no deficiency.  However, if the evidence establishes that the facility fell short of taking all necessary precautions, it has violated the regulation.  Fireside Lodge Ret. Ctr., DAB No. 2794 at 12 (2017) (holding that the issue was not whether a pressure sore could be expected to heal, but rather whether the facility staff provided the care and services necessary to promote healing); Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300 at 13-14 (2010), aff’d, Senior Rehab. & Skilled Nursing Ctr. v. U.S. Dep’t of Health & Hum. Servs., 405 F. App’x 820 (5th Cir. 2010); Koester Pavilion, DAB No. 1750 at 2 (2000).

Facility Procedures.  The facility had in place a “Skin Alteration Reporting and Documentation” protocol.  CMS Ex. 7.  The protocol required, “[u]pon noting a new skin alteration,” a change in condition and skin alteration report was to be initiated as soon as the occurrence was discovered or reported.  Id. at 1.  However, according to Petitioner, the protocol is not applicable here because R1 entered the facility with an existing Stage 1 pressure ulcer on her sacrum.  P. Br. at 2; P. Ex. 9 ¶ 13 (affidavit of T.Ro., Vice President of Nursing and Clinical Services for Petitioner).

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Petitioner explains the “facility [did] not have a written policy for incidents where the resident developed an initial skin alteration prior to Resident’s admission[,]” but proffers its general practice.  P. Ex. 9 ¶ 14.  T.Ro. explains that when a resident has an existing wound, the resident is referred to the primary care physician who will then order a wound care consult if appropriate.  Id. ¶ 15.  The resident will then be seen by a wound care specialist, generally within a week.  Id. ¶¶ 16-17.  The specialist “should conduct a full body exam” and make recommendations, which are then reviewed by the primary care physician who will then issue a wound care order.  Id. ¶¶ 18-19.  The facility relies on the expert opinion of the wound care specialist and physician’s orders to determine how to care for its residents.  Id. ¶¶ 20-21.  Finally, T.Ro. states that the facility cannot take any material steps to care for an existing wound without the physician’s express order.  Id. ¶ 22.

R1.  R1 was admitted to the Petitioner’s facility on January 29, 2021.  P. Ex. 1 at 1.  R1 was admitted with an existing deep tissue injury (DTI) on her left heel and a pink area on her sacrum.  Id. at 4.  R1 was evaluated to be at risk for pressure sores at the time of admission.  Id. at 3.  R1 was documented to be chairfast (her ability to walk marked as non-existent), had very limited mobility (described as able to make occasional slight changes in body or extremity position, but unable to make frequent or significant changes independently), and friction and shearing evaluated as potential problems.  Id.  On the date of her admission, the physician ordered “Weekly Skin Checks on Friday on (7-3) shift” with instructions to code the findings.  CMS Ex. 8 at 111.  None of these facts are in dispute.

Despite the physician’s express order, the facility’s February 2021 treatment records fail to document that the weekly skin checks were performed, and the findings documented.  CMS Ex. 5 at 43-44; see CMS Br. at 4.  I acknowledge Petitioner’s contentions that lack of documentation is not indicative of whether treatment or services are provided or not.  P. Ex. 5 at 14 (G.R. Expert Report stating “[i]t cannot be determined if the treatment or medication was administered and not documented without interview of the staff assigned to provide care on these days.”); P. Ex. 9 ¶ 30.  Petitioner also proffers the declaration of L.S., the facility’s Director of Nursing (DON), who states that staff do not always note when services are rendered and that a failure to sign does not indicate that a service was not provided.  P. Ex. 14 ¶¶ 5-6.

However, Petitioner has not presented any evidence that the weekly skin checks were conducted as ordered in February 2021.  Here, the facility’s treatment records for February 2021 include the physician’s order for weekly skin checks, starting January 29, 2021, but the corresponding entries are blank.  CMS Ex. 5 at 44; cf. CMS Ex. 5 at 50, 54, 59, 65, 68, 71, 80, 85 (facility treatment records from April 2021 forward recording the completion of weekly skin assessments and documented as ordered); see also P. Exs. 7, 8 (certified nursing assistants’ (CNAs) declarations describing the care they provided to R1, which notably omit any mention of weekly skin checks).  Therefore, the DON’s

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broad and general statement that “there was every indication that [R1] was provided with the proper wound care per the doctor’s instructions” is insufficient to cast even a “metaphysical doubt” on the accuracy of the treatment records, which reflect the care that was provided as well as the care that was not provided.  P. Ex. 14 ¶ 9.

In coming to this conclusion, I have considered Petitioner’s contentions that it outsourced wound care to a third party.  P. Br. at 6.  And, according to the facility’s Vice-President of Nursing and Clinical Services, “[t]he wound care specialist should conduct a full body exam and make any recommendations they feel are appropriate.”  P. Ex. 9 ¶ 18.  However, the wound care specialist does not claim that she performed full body exams, nor does she document the same in the contemporaneous visit records.  P. Ex. 6 ¶ 10 (wound care specialist stating that she assessed the resident’s sacral wound, not that she performed skin checks pursuant to the physician’s orders); P. Ex. 2 (wound care records limiting skin observations to existing wounds).

To the extent the facility attempts to shift responsibility to a third party, as a provider seeking Medicare payment for care it provides to beneficiaries, Petitioner was obliged to “provide services to attain or maintain the highest practicable physical, mental, or psychosocial well-being of each resident.”  Act § 1819(b)(2), 42 U.S.C. § 1395i-3(b)(2).  As such, even if the facility relied on the wound care specialist to perform the weekly skin assessments ordered by R1’s physician, upon review of the wound care records, the facility was on notice that the assessments were not performed and/or documented as ordered.  Compare P. Ex. 2 (wound care records limiting skin examinations to existing wounds) and id. at 1-7 (February and March 1, 2021 wound care records lacking any mention of the resident’s existing sacral wound), with CMS Ex. 8 at 111 (instructions to code the findings as 0 (skin intact), 1 (no new changes), and 2 (new skin breakdown)).  The responsibility was on the facility to ensure the resident received all physician-ordered services, either by having its staff perform the weekly skin assessments or directing the wound care specialist to perform all services as ordered.  The proffered evidence shows the facility did neither.

The undisputed facts thus show that the facility failed to perform weekly skin assessments and document those findings as ordered by R1’s physician.  Failure to follow the physician’s orders alone puts the facility out of substantial noncompliance with the program requirements.  Cedar Lake Nursing Home, DAB No. 2390 at 3 (2011) (citing Woodland Vill. Nursing Ctr., DAB No. 2053 at 9 (2006), aff’d, Woodland Vill. Nursing Ctr. v. U.S. Dep’s of Health & Hum. Servs., 239 F. App’x 80 (5th Cir. 2007), citing Lakeridge Villa Health Care Ctr., DAB No. 1988 at 22 (2005), aff’d, Lakeridge Villa Health Care Ctr. v. Leavitt, 202 F. App’x 903 (6th Cir. 2006)).

Moreover, the facility’s noncompliance caused R1 actual harm.  R1 was admitted to the facility with a DTI and a Stage 1 sacral pressure ulcer and was assessed as being at risk for developing additional pressure ulcers.  P. Ex. 1.  Given R1’s condition, it was critical

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for the facility to conduct skin assessments as ordered, both to monitor the effectiveness of the prescribed treatment for R1’s existing wounds and to prevent further skin breakdown.  Had the weekly skin assessments been completed as ordered, it would have become evident that R1’s sacral ulcer was not healing.  Instead, by the time there is any assessment of the sacral area, 28 days after admission, the previously pink area had already worsened into an open wound.  CMS Ex. 5 at 24.

The facility’s substantial noncompliance, however, goes beyond its failure to perform and document the weekly skin assessments.  As discussed below, the undisputed evidence establishes that the treatment ordered (or not ordered), combined with the facility’s failure to consistently provide the prescribed care for R1’s sacral pressure ulcer, fell well short of taking all necessary precautions to promote healing and prevent infection.

Petitioner unequivocally asserts the pink area on R1’s sacrum, identified on admission, was “an existing stage 1 pressure ulcer . . . .”  P. Br. at 2; P. Ex. 9 ¶ 11 (Vice President of Nursing and Clinical Services for facility stating that the pink sacral wound at the time of admission met the definition of a stage 1 pressure ulcer).  Because R1 presented with an existing pressure ulcer, Petitioner was required to ensure that R1 received all the necessary treatment and services to promote healing and prevent infection of the wound.  However, other than identifying the pink area on R1’s sacrum, there are no documented orders or care planning specifically related to the treatment of the area at or around the time of admission.

Although not at issue, it is useful to review the care ordered for the DTI present on R1’s left heel at and shortly after her admission to the facility.  On January 30, 2021, the physician ordered offloading heels in bed every shift, and, on February 5, 2021, a wound care consult was ordered.  CMS Ex. 5 at 2; CMS Ex. 8 at 109; see also CMS Ex. 5 at 107 (wound care note indicating “current treatment is skin prep” for the left heel injury).  On February 8, 2021, the wound care consult was completed.  CMS Ex. 5 at 107 (page 1 of wound care patient visit record, dated February 8, 2021); P. Ex. at 1 (page 2 of wound care patient visit record, dated February 8, 2021).  The plan to treat the ulcer on the left heel included discontinuing skin prep, and to start cleansing the affected area with NSS or wound cleanser, applying Silvadene cream, covering with border gauze dressing, to monitor for signs and symptoms of infection, off-loading pressure and continue repositioning.   CMS Ex. 5 at 107; P. Ex. 2 at 1.  These interventions are documented as in effect by the following week.  P. Ex. 2 at 2-3.

In comparison, there are no documented orders related to the treatment of the sacral wound until February 26, 2021, approximately a month after R1’s admission, and on the date a nurse observed the wound opening.  P. Ex. 3; CMS Ex. 5 at 24.  The lack of documented orders is significant because, as the facility’s Vice-President of Nursing and Clinical Services explains, “[t]he facility staff cannot, without the physician’s express order, take any material steps to care for an existing wound.”  P. Ex. 9 ¶ 22 (emphasis

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added).  Therefore, to satisfy the regulatory requirement of taking all necessary precautions to promote healing of an existing pressure ulcer, it was essential for the physician to issue express orders for the care and treatment of R1’s sacral wound upon admission.  However, no such orders are reflected in the proffered evidence.

I have considered the declaration of R1’s primary care physician who states that her “standing orders for the resident included application of Balmex, a protective skin barrier cream, to be applied to the buttocks and sacral area regularly as a preventative measure, together with the use of pressure relieving devices, turning and repositioning, and offloading pressure.”  P. Ex. 13 ¶ 4 (Dr. D.’s affidavit).  However, Petitioner fails to provide a copy of these standing orders.  Cf. CMS Ex. 5 at 94, 97 (care plan established on June 25, 2021, following readmission from hospital).  Similar to its general unwillingness to accept that treatments that are not documented have nevertheless been performed, the Board has not been “willing to assume that an order that was not documented at the facility was nevertheless communicated to and complied with by the nursing staff, absent credible evidence of such communication.”  River City Care Ctr., DAB No. 2627 at 8 (2015) (internal citations omitted).

Moreover, even affording the physician’s declaration all reasonable inferences, including the assumption that the standing orders were issued at the time of R1’s admission for treatment of her sacral wound, the lack of specificity renders them insufficient to establish that the facility took all necessary precautions to promote healing of R1’s pressure ulcer.  The physician’s statement fails to specify how often the preventative cream was to be applied, or the frequency staff were required to reposition R1.  P. Ex. 13.  Similarly, the physician fails to explain what type of pressure relieving devices were provided to R1 for the treatment of her sacral wound.  Cf. P. Ex. 2 at 9 (March 8, 2021 wound care visit stating interventions needed included a low air loss mattress and upgraded cushion to wheelchair, signifying that neither of these were ordered for R1 at admission).

At most, Petitioner’s proffer establishes the general care that the facility provides to residents who are at risk for developing or worsening ulcers.  See P. Exs. 7 ¶ 4, 8 ¶ 4 (declarations of two CNAs who describe care provided to residents considered at risk of developing or worsening a pressure ulcer but not stating whether there were orders specific to R1).  However, it fails to demonstrate whether this “general care” met R1’s specific clinical needs.  The proffered evidence shows that it did not.  Based on the February 26, 2021 nurse’s note, it is apparent that the repositioning measures being employed were not effective for R1 because of noncompliance.  CMS Ex. 5 at 24.  There is no evidence that the noncompliance was reported to the physician or, if it was reported, whether the physician ordered any alternative measures to promote the healing of R1’s sacral wound.  Because the facility failed to take these steps, it cannot be said that it took all necessary precautions to promote healing, prevent infection and prevent new sores from developing.

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Moreover, while I have no reason to doubt the CNAs’ statements that they applied Balmex to R1’s sacral area and repositioned her approximately every two hours, and that they personally cared for this resident since her admission, there is no basis to determine the frequency of the treatment they (and other CNAs) provided or whether the treatment was provided in accordance with the physician’s orders because there are no contemporaneous notations in the treatment records.  See CMS Ex. 5 at 43-44 (February 2021 treatment records, which do not include orders for preventative cream or repositioning).  In other words, based on the evidence presented, I cannot reasonably infer that the preventative cream and repositioning measures were consistently provided and pursuant to and in compliance with the physician’s orders.  Mission Hosp. Reg’l Med. Ctr., DAB No. 2459 at 8 (2012) (“[T]he reviewer must view the evidence in the light most favorable to the non-moving party, drawing all reasonable inferences in that party’s favor.”).  Without such evidence, I cannot rationally conclude that the facility took all necessary precautions to promote the healing of R1’s existing sacral ulcer.  Instead, the undisputed evidence shows that within the first month of R1’s admission – during which there are no documented orders or treatment records specifically addressing R1’s sacral pressure ulcer – the initially described “pink area” had progressed to a “sacral wound approx. silver dollar sized pink tissue observed open [with] 0 drainage noted.”  CMS Ex. 5 at 24.

Even after the sacral wound had deteriorated and orders related to its treatment finally documented, the undisputed evidence shows a delay in treatment.  For example, despite a wound care consult being ordered on February 26, 2021, and the wound care specialist visiting R1 on March 1, 2021, the wound care specialist did not “see [the] new wound to [R1’s] sacral region” until March 8, 2021, ten days after the consult was ordered.  Compare P. Ex. 2 at 6-7, with P. Ex. at 8-9.  Similarly, despite the deterioration of the wound, the low air mattress ordered for R1 was not noted as being in place until March 22, 2021, and the wheelchair cushion, even later on April 12, 2021.  Id. at 10-19.  Petitioner offers no explanation for the delay in providing these interventions.

Finally, I address Petitioner’s contentions that because it “complied with all the material physician orders and wound specialist recommendations, [the facility] cannot be held responsible for further development of the sacral pressure ulcer.”  P. Br. at 24.  I agree that case law supports treatment orders are the best evidence of “the necessary treatment and services” to facilitate healing based on professional standards of practice.  Fireside Lodge Ret. Ctr., Inc., DAB No. 2794 at 12-13 (2017) (Petitioner’s failure to follow physician’s orders for treating a Resident’s pressure ulcer as reason for affirming determination of deficiency); Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300 at 13-19 (2010) (Petitioner “did not take all necessary precautions to promote healing” of a Resident’s pressure ulcers when it failed to follow Resident care plans and its own facility’s policy.), aff’d, Senior Rehab. & Skilled Nursing Ctr. v. Health & Hum. Servs., 405 F. App’x 820 (5th Cir. 2010).  However, the evidence presented does not support a

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finding that the facility complied with the physician’s orders by consistently administering the prescribed treatments.  See, e.g., CMS Ex. 5 at 61, 62, 65, 66, 69, 71, 73, 74, 82, 84 (treatment records following R1’s readmission to the facility from the hospital showing multiple instances where treatments were not administered as ordered).  Again, I acknowledge Petitioner’s contentions that failure to document does not necessarily mean a failure to perform.  P. Ex. 5 at 14 ( “It cannot be determined if the treatment or medication was administered and not documented without interview of the staff assigned to provide care on these days.”).  However, Petitioner has not proffered any evidence, other than speculation, that the prescribed treatment was administered.  See, e.g., P. Ex. 6 ¶ 17; P. Ex. 9 ¶¶ 28-29; P. Ex. 13 ¶ 6; P. Ex. 14 ¶ 9.  As already stated, mere speculation without any supporting evidence is insufficient to cast even a metaphysical doubt on the accuracy of the treatment records.

In sum, substantial compliance in this case hinges on the facility’s provision of care in accordance with professional standards of practice to promote pressure ulcer healing.  Although the evidence reflects some periods of wound stability and improvement, the undisputed evidence also reveals significant gaps in treatment.  There were significant periods when no care was documented as ordered, and when ordered care was documented, it was delivered inconsistently.  Compare, e.g., CMS Ex. 5 at 46-56 (documentation of physician’s orders and treatment records documenting that ordered care was provided in March through June 2021), with, e.g., CMS Ex. 5 at 61-84, and P. Ex. 2 at 1-7 (February 2021 wound care records that fail to reference, much less suggest a plan of care, for R1’s sacral wound); see also CMS Ex. 5 at 61, 62, 65, 66, 69, 71, 73, 74, 82, 84.  It is undisputed that R1 was hospitalized for treatment of her sacral wound in June 2021, by which time the wound had progressed to a stage 4 pressure ulcer.  CMS Ex. 8 at 9.  After returning to the facility from the hospital, the proffered evidence shows that the facility failed to consistently follow the physician’s orders, and by October 2021, an MRI revealed R1 had a decubitus ulcer with osteomyelitis for which she required IV antibiotics.  CMS Ex. 5 at 18.

Based on the proffered evidence, even when considered in a light most favorable to Petitioner, no rational trier of fact could reasonably conclude that the Petitioner took all necessary precautions to promote healing and prevent infection of R1’s sacral wound.  The Harborage, DAB No. 2905 at 1-2 (2018).  Therefore, I find Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(b)(1)(ii).

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2. The per-instance CMP imposed is reasonable.

Petitioner does not argue that the CMP is unreasonable but instead proffers that there is no basis for a penalty because it was not out of substantial compliance with Medicare program requirements.  P. Br. at 24-25.  Having found otherwise, and in the absence of any additional argument or evidence to the contrary, Petitioner has likely waived the issue.  Nevertheless, I next consider whether the CMP imposed is reasonable by applying the factors listed in 42 C.F.R. § 488.438(f), which include: (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, including neglect, indifference, or disregard for resident care, comfort or safety.  “The absence of culpability is not a mitigating circumstance in reducing the amount of the penalty.”  42 C.F.R. § 488.438(f)(4).  The burden is on the facility “to demonstrate, through argument and submission of evidence addressing the regulatory factors, that a reduction is necessary to make the CMP amount reasonable.”  Heritage Plaza Nursing Ctr., DAB No. 2829 at 22 (2017) (quoting Oaks of Mid City Nursing & Rehab. Ctr., DAB No. 2375 at 26-27 (2011)).  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).

CMS imposed a per-instance CMP of $12,515, which is slightly higher than half the amount that CMS is authorized to impose for per-instance noncompliance (authorized range for per-instance noncompliance is from $2,259 to $22,589).  42 C.F.R. § 488.438(a)(2); 45 C.F.R. § 102.3 (2021); 86 Fed. Reg. 62,928, 62,938 (Nov. 15, 2021).  CMS has offered evidence showing a history of noncompliance, including two G-level deficiencies related to pressure sores.  CMS Ex. 4 at 11, 13.

Petitioner does not offer any argument or evidence related to its financial condition.  Heritage Plaza Nursing Ctr., DAB No. 2829 at 22 (2017) (stating the burden is on the facility to demonstrate, through argument and submission of evidence addressing the regulatory factors, that a reduction is necessary to make the CMP amount reasonable).

Finally, the severity of the deficiency is significant.  R1 entered the facility with a pink sacrum.  P. Ex. 1 at 4.  R1 was assessed to be at risk for developing pressure sores.  Id. at 3 (noted to be chairfast and with very limited mobility; friction and shearing identified as potential problems).  Despite being admitted with a stage 1 pressure ulcer on her sacrum, there were no written orders to promote the healing of the pressure sore on R1’s sacrum at the time of admission, except for weekly skin checks, which were not documented as completed in the treatment record.  CMS Ex. 8 at 111; CMS Ex. 5 at 47; see also P. Ex. 3 at 1 (physician’s order for sacral wound dated February 26, 2021).  R1’s sacral wound deteriorated within a month of her admission, going from a pink area to a “silver dollar sized pink tissue observed open [with] 0 drainage noted.”  CMS Ex. 5 at 24.  R1 would later require hospitalization for the treatment of her sacral wound.  CMS Ex. 8.  Following R1’s return to the facility, staff failed to consistently document the treatment it

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provided to R1 to promote the healing of the wound.  See, e.g., CMS Ex. 5 at 61, 65, 71.  Eventually, R1 was diagnosed with osteomyelitis and required IV antibiotics.  Id. at 18, 92.  The ultimate fate of R1 is unknown.  See id. at 37 (noting R1 was admitted to hospital with septic shock).  The seriousness of the deficiency, coupled with the facility’s history of noncompliance, justifies the penalty amount.

IV.     CONCLUSION

The undisputed evidence establishes that the facility was not in substantial compliance with Medicare program requirements.  The penalty imposed – a $12,515 per-instance CMP – is reasonable.  I therefore grant CMS’s motion for summary judgment.