Luther Manor Health Care Center, DAB CR6348 (2023)

DECISION

Luther Manor Health Care Center (hereinafter referred to as “Luther Manor,” “Petitioner,” or “the facility”) challenges the determination by the Centers for Medicare & Medicaid Services (CMS) that it was not in substantial compliance with multiple Medicare participation requirements and that certain noncompliance posed immediate jeopardy to resident health and safety.  Petitioner also challenges the imposition of a $7,030 per day civil money penalty (CMP) from May 14, 2021, through May 25, 2021; a $540 per day CMP from May 26, 2021, through June 28, 2021; and the loss of its approval for its Nurse Aide Training and Competency Evaluation Program (NATCEP).

As explained below,  the record supports the facility’s noncompliance with Medicare requirements and supports the immediate jeopardy determination.  There is a basis for the imposition of enforcement remedies and the per day CMP amounts are reasonable.

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I.    Background and Procedural History

Luther Manor Health Care Center is a skilled nursing facility (SNF) located in Milwaukee, Wisconsin, that participates in the Medicare program.  CMS Exhibit (Ex.) 4 at 1.  The Wisconsin Department of Health Services (state agency) completed a complaint investigation survey on May 27, 2021.  CMS Ex. 4 at 1; CMS Ex. 2 at 1.  The state agency surveyors found, and CMS later agreed, that the facility was not in substantial compliance with the following Medicare participation requirements:

• 42 C.F.R. § 483.25(b)(1)(i)-(ii) (Tag F686 – Treatment/Services to Prevent/Heal Pressure Ulcer), scope and severity (s/s) level J.
• 42 C.F.R. § 483.40(b)(3) (Tag F744 – Treatment/Service for Dementia), s/s level G;
• 42 C.F.R. §§ 483.10(e)(1), 483.12(a)(2) (Tag F604 – Right to be Free from Physical Restraints), s/s level D; and
• 42 C.F.R. § 483.15(c)(7) (Tag F624 – Preparation for Safe/Orderly Transfer/Discharge), s/s level D.

CMS Ex. 4.  By letter dated September 21, 2021, CMS notified Petitioner of the noncompliance determinations and resulting remedies.  CMS Ex. 2 at 1.  CMS explained that the facility abated the immediate jeopardy conditions on May 26, 2021, but remained out of substantial compliance with requirements until June 29, 2021.  CMS Ex. 2 at 1-2.  CMS imposed a $7,030 per day CMP for 12 days beginning May 14, 2021, through May 25, 2021; and a $540 per day CMP for 34 days beginning May 26, 2021, through June 28, 2021.  CMS Ex. 2 at 2.  The total CMP amount is $102,720.  CMS Ex. 2 at 2.  CMS also explained that, because the noncompliance cited under Tag F686 constituted substandard quality of care, which required a partial extended survey, Petitioner was prohibited from offering or conducting a NATCEP for two years.  CMS Ex. 2 at 1, 4.

Petitioner filed requests for hearing on August 4, 2021, and September 30, 2021.  The cases were assigned to me and consolidated for hearing and decision under Docket No. C-21-1124.

CMS timely filed a prehearing exchange that included a combined motion for summary judgment and prehearing brief, as well as 16 proposed exhibits (CMS Exs. 1-16).  Three of CMS’s exhibits (CMS Exs. 12, 14, and 16) are written direct testimony from witnesses.  Luther Manor timely filed a brief titled “Combined Prehearing Brief and Request for Hearing and Motion to Dismiss CMS’s Motion for Summary Judgment,” as well as 11 proposed exhibits (P. Exs. 1-11).  Three of Luther’s exhibits (P. Exs. 9-11) are written direct testimony from witnesses.

As explained in the July 18, 2022 Order, absent objections, CMS Exs. 1-16 and P. Exs. 1-11 were admitted into evidence.

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II.    Decision on the Record

On June 27, 2022, CMS’s motion for summary judgment was denied and the case was set for a hearing.  On August 2, 2022, before the scheduled hearing date, Petitioner waived its right to an oral hearing and requested a decision on the record.  CMS did not oppose Petitioner’s request.  The hearing was canceled, and each party filed supplemental briefs (CMS Supp. Br.; P. Supp. Br.).  Order (Aug. 19, 2022).

The record is closed and this decision will be issued based on the written record.  Standing Prehearing Order ¶ 13; Civil Remedies Division Procedures § 19(b), (d).

III.    Issues

Because Luther Manor has not challenged the findings of noncompliance with 42 C.F.R. §§ 483.10(e)(1), 483.12(a)(2) (Tag F604) and 42 C.F.R. § 483.40(b)(3) (Tag F744), those deficiencies are administratively final.  Ruling Denying Motion for Summary Judgment at 4-5 (Jun. 27, 2022).  The unchallenged deficiencies provide a basis for CMS to impose a CMP of at least $112 per day, which is the relevant regulatory minimum amount in effect at the time the penalty was assessed.  42 C.F.R. § 488.438; see 45 C.F.R. § 102.3 (2020); 85 Fed. Reg. 2869, 2880 (Jan. 17, 2020); CMS Ex. 2.

The remaining issues are as follows:

1. Whether Luther Manor was in substantial compliance with 42 C.F.R. § 483.25(b)(1)(i)-(ii) (Tag F686, s/s level J);
2. Whether Luther Manor was in substantial compliance with 42 C.F.R. § 483.15(c)(7) (Tag F624, s/s level D)¹ ;
3. If Luther Manor was not in substantial compliance with 42 C.F.R. § 483.25(b)(1)(i)-(ii) (Tag F686), whether CMS’s immediate jeopardy determination was clearly erroneous;

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4. If Luther Manor was not in substantial compliance, whether a $7,030 per-day CMP for 12 days beginning May 14, 2021 through May 25, 2021, and a $540 per-day CMP for 34 days beginning May 26, 2021 through June 28, 2021 are reasonable; and
5. If Luther Manor was not in substantial compliance, whether there is a basis to prohibit the approval of Luther’s NATCEP.

IV.    Jurisdiction

This tribunal has 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).

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 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).

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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 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 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.

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(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).

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VI.    Findings of Fact

1. Resident 2 (R2)’s pressure injury

R2 was a 72-year-old woman admitted to Petitioner’s facility on April 14, 2021, following a brief hospital stay to treat a COVID infection.  CMS Ex. 7 at 127; P. Ex. 1.  R2 had a history of chronic obstructive pulmonary disease (COPD), a cerebral vascular accident (stroke), and moderately impaired decision making (Brief Interview for Mental Status (BIMS) score of 11).  CMS Ex. 7 at 1, 122, 127-28.  At the time of R2’s admission, she used a walker and wheelchair, and required one person to assist her with bed mobility, transferring, toileting, and personal hygiene.  CMS Ex. 7 at 135, 141-42.  Before being hospitalized, R2 lived with her husband and daughter.  P. Ex. 1 at 1.

An initial skin assessment conducted when R2 initially entered the facility documented the following minor conditions:  “Skin is warm, dry, and intact.  Skin turgor is WNL [within normal limits].  Scar tissue and redness noted to coccyx but [blanching].  Cyst noted to ABD [abdomen] resident states [it’s] been there for years no pain or discomfort noted.  Bruises noted to left AC [shoulder].”  CMS Ex. 7 at 17, 127.  R2’s Braden Scale assessment, a pressure injury risk tool, revealed a score of “17,” meaning that R2 was “at risk” for developing pressure injuries.  Id. at 128.

On April 17, 2021, three days after admission to the facility, R2 was sent to the hospital emergency room due to confusion and shivers.  Id. at 114.  R2 returned to the facility after spending several hours at the hospital.  Id.  The hospital did not issue any new orders for R2.  Id.

Two days later, on April 19, 2021, a nurse noticed an “open area” to R2’s left buttock.  CMS Ex. 7 at 109.  The next day, the wound nurse assessed R2 with a pressure ulcer, noting in her evaluation:  “Left side of buttock currently with unstageable PI [Pressure Injury] present.  Appears to be DTI [deep tissue injury] that was present to left side of buttock/sacrum & since no treatment performed DTI opened & currently is unstageable.”  CMS Ex. 7 at 24.  At that time, R2’s wound measured 3.3 cm x 3.1 cm giving it an area of 5.6 cm2.  Id. at 19.  The wound bed had 10% granulation and there was no odor.  Id. at 19-20.

On April 23, 2021, R2 stated that her bottom hurt, and she was uncomfortable in bed.  In response, a pillow was placed under one side of her to take some additional pressure off of her buttocks.  CMS Ex. 7 at 81.  A dressing change was ordered later that day and a moderate amount of tan and red drainage was noted.  Id.  

The resident’s care plan was updated for staff to treat the wound and new interventions included an order for a new air mattress.  CMS Ex. 7 at 162.  Facility staff members were directed to document the wound healing progress:  “Assess/record/monitor wound

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healing every shift:  Measure length, width and depth where possible.  Assess and document status of wound perimeter, wound bed and healing progress.  Report improvements and declines to the MD [doctor].”  CMS Ex. 7 at 163.

The resident was evaluated a week later, on April 27, 2021, and the wound nurse documented that the wound had “increased in size extending to mid coccyx area,” measuring 3.5 cm x 4.4 cm, with an area of 11.7 cm2.  Id. at 26.  The wound nurse noted:  “Depth of PI [Pressure Injury] = less than 0.1cm.  Boggy brown slough tissue to wound has opened with only 20% of wound bed still with brown slough tissue present, yellow/slough tissue present to 50% of wound bed with new onset red/granulation tissue to wound bed.”  Id.  The evaluation also reflected that there was “pain present to PI [Pressure Injury] to left side of buttock extending to mid coccyx when area is touched/palpated during dressing change” and that R2 “reports pain level of 2/10 during dressing changed.”  Id. at 29.

R2 was prescribed medi-honey to be applied to the wound bed to debride the slough tissue.  Id. at 26.  The wound nurse also noted that the wound would “continue to get worse until all brownish colored boggy slough tissue is removed from wound bed” and that the new treatment orders were “appropriate with no concerns present.”  Id. at 31.  Finally, the nurse marked the evaluation form to indicate “Slow to Heal: wound healing is slow or stalled but stable, little no deterioration.”  Id. at 29, 31.

Staff continued to treat R2’s wound, and a progress note dated April 30 indicates that the resident received Tramadol (pain medication) after she complained of pain to her buttocks.  CMS Ex. 7 at 53.

R2 was discharged on May 3, 2021, just before she was scheduled to receive her next weekly skin assessment.  P. Ex. 10 ⁋⁋ 8-9.  After the resident’s discharge, R2’s family had concerns about R2’s wound and so they took her to the hospital.  CMS Ex. 7 at 226 (“At discharge from this facility yesterday family noted a significantly enlarged and draining sacral ulcer, prompting them to bring patient to the ED [emergency department] . . . .”).

The hospital notes state that “[t]here is a low large in deep ulcer going down to bone and imaging has demonstrated osteomyelitis of the sacrum.”  Id.  Another note described the wound as a “deep stage IV sacral ulcer with concern for [osteomyelitis]” and documented that R2 “underwent debridement with excision of coccyx under general anesthesia.”  Id. at 200.  The hospital notes also indicate that the “sore” was “very painful.”  Id. at 201.  R2 passed away on May 14, 2021.  Id. at 199-200.  The cause of death was reported as “[a]cute on chronic hypoxic and hypercapnic respiratory failure” and “COPD,” but her “Stage IV sacral ulcer” was also listed as a “[s]ignificant [c]ondition[].”  Id. 

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2. R2’s discharge

On April 19, 2021, two weeks before R2’s discharge, Petitioner held an initial care conference to plan for R2’s discharge.  CMS Ex. 7 at 108.  Notes from that initial conference state:  “Care conference scheduled for the resident today.  Present were writer, ADT [admission, discharge, transfer] Nurse and resident. . . . Therapy also reported that the resident is max assist x2 with transfer trials with therapy and standing tolerance 10 seconds approximately. . . . Discharge plan is to return home with daughter [L].”  CMS Ex. 7 at 108.

The following week, on April 26, 2021, the facility held the discharge care conference.  CMS Ex. 7 at 69.  Notes from the discharge conference state:

Care conference scheduled for the resident today.  Present was writer, ADT [admission discharge transfer] Nurse and resident.  Resident does request that writer call daughter [L] after the care conference is completed.  Writer acknowledged.  Writer provided therapy report per notes provided that resident is currently moderate assistance with transfers and ADL [activities of daily living] tasks in PT [physical therapy] and OT [occupational therapy] trials. . . . Therapy is recommending PT/OT in home upon discharge with recommended 24/7 assistance from family member(s).  Resident confirmed that resident’s family does provide assistance throughout the day therefore this is not a concern.  Resident confirmed that resident’s family does provide assistance throughout the day and therefore this is a not concern.  Resident confirmed that resident lives with daughter [L] and husband currently residents in Arkansas. . . . Discharge plan will be to go home with daughter with PT/OT referral to be sent to Aurora at Home.  Resident informed IDT [interdisciplinary team] that resident will speak with daughter [L] to confirm the pick-up time and will let IDT know.

CMS Ex. 7 at 69.

On April 30, 2021, social services provided written notice (Notice of Medicare Non-Coverage) to R2 that her insurance would no longer be covering the facility’s care.  CMS Ex. 7 at 49, 52.  R2 expected to stay at the facility longer and appealed the denial to the Quality Improvement Organization (QIO).  See CMS Ex. 7 at 178 (indicating “[e]arlier [than] planned [discharge] due to insurance denied.”).  However, by letter dated May 1, 2021, the QIO upheld the determination that R2 “no longer require[d] skilled nursing facilities services” and that R2’s services “will no longer be covered (paid for) by the Medicare program beginning May 3, 2021.”  P. Ex. 7 at 3-4.

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It is undisputed that at the time of her discharge on May 3, 2021, R2 required two people and maximum assistance for transfers.  The facility issued a discharge summary, which stated:  “Currently you need 2 people to help you stand up and transfer. . . .  Do not try to get up on your own.”  CMS Ex. 7 at 195.  R2’s physical therapy discharge summary stated the following:  “Max A [assistance] needed for bed mobility.  Max A of 2 for transfers.  Pt [Patient] is not able to ambulate at this point.  Pt is discharging to her daughter’s home with assist for all mobility.  Pt will continue to [have] PT thru HH [home health].”  CMS Ex. 7 at 178.  A physician’s discharge order states that R2 needed ongoing wound care, PT, and OT post-discharge.  P. Ex. 6.

It is also undisputed that R2 was discharged to live with her daughter, who lives alone.  CMS Ex. 13 at 30 (interview notes that R2’s daughter reported she lives alone).  On the discharge date, Luther Manor’s social services arranged for PT, OT, and ongoing nursing assistance for wound care at home.  CMS Ex. 7 at 40 (Luther Manor’s social services team communicated the orders to Aurora, a home care agency, on May 3, 2021, to ensure ongoing care was provided to R2 once she returned to the community).  In an interview, a staff member reported that, on the day of her discharge, R2 said she was “being kicked out of the facility and that the facility only wanted her money.”  CMS Ex. 4 at 12; CMS Ex. 3 at 21 (surveyor notes that resident “was worried about facility getting ‘husband’s pension’”).

VII.    Analysis and Conclusions of Law

1. Luther Manor was not in substantial compliance with 42 C.F.R. § 483.25(b)(1)(ii) (Tag F686) because it failed to assess and measure R2’s wound every shift as ordered by R2’s care plan.

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

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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).

The record shows that Luther Manor failed to comply with R2’s care plan which called for staff to “[a]ssess/record/monitor wound healing every shift:  Measure length, width, and depth where possible.  Assess and document status of wound perimeter, wound bed, and healing progress.  Report improvements and declines to the MD.”  CMS Ex. 7 at 163 (emphasis added); CMS Br. at 11.  There are no notes concerning the resident’s wound for at least two full days—April 24 and 26th.  Outside of the two weekly formal assessments, there is only one additional progress note, on April 28, indicating that the size of R2’s wound was measured.  CMS Ex. 7 at 59 (documenting “wound bed has yellow eschar to lower and lateral upper sides with dark eschar size of a nickel”).³   The remaining progress notes that address the wound simply document dressing changes and whether there was any drainage or signs of infection.  Without measurements of the wound, as called for by the resident’s care plan, staff were effectively precluded from tracking the wound’s progression outside of the formal weekly assessments.   CMS’s expert, Dr. Dan R. Berlowitz, opined that the wound’s eventual progression to the bone “likely should have been observable by facility staff several days before [R2’s hospitalization] with a proper assessment.”  CMS Ex. 16 ¶ 13.

Initially, Petitioner acknowledged that the care plan called for assessments and measurements every shift but now argues that this “was above and beyond the standard of practice, which requires formal assessments to take place on a weekly basis only.”  P. Br. at 17.  Luther Manor’s expert, Dr. Tareq Maraqa, stated that the facility “properly assessed the pressure injury every seven days” with a wound nurse, which is “consistent with the regulations and the standard of practice unless there is an infection.”  P. Ex. 11 ¶ 6.

Petitioner’s argument is not persuasive.  The noncompliance is not based on the failure to complete formal weekly assessments, but based on the failure to comply with R2’s care plan which called for assessments and measurements every shift.  “[T]he Board has observed that where a facility itself requires that specific measures be taken, either in its policies or in the care plans it develops for its residents, those measures are evidence of the facility’s evaluation of what must be done to attain or maintain a resident’s ‘highest practicable physical, mental, and psychosocial well-being’ as required by the overarching introductory language to section 483.25.”  Azalea Court, DAB No. 2352 at 9 (2010); see also Spring Meadows Healthcare Ctr., DAB No. 1966 at 17 (2005) (“the clearest case of failure to meet [section 483.25] is failure to provide one of the specific services outlined

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in the subsections or failure otherwise to follow the plan of care based on the comprehensive resident assessment”).  Thus, even assuming the standard of practice requires formal assessments to be conducted weekly only, staff determined that the resident needed assessments and measurements on a more frequent basis—every shift—and staff utterly failed to follow those instructions.

Petitioner also argues that “the near daily progress notes indicate R2’s wound was being monitored ‘frequently.’”  P. Br. at 17.  But such monitoring was inadequate as it did not include measuring the size and depth of the wound, as called for by R2’s care plan.  CMS’s expert, Dr. Berlowitz, noted that “[p]rogression to the bone would not have happened overnight,” yet Luther has not offered an explanation as to how the resident’s wound had progressed to that point.  CMS Ex. 16 ¶ 13.

Dr. Berlowitz stated that “R2’s wound should have been assessed more than once weekly because of how quickly it was progressing,” adding that “weekly is ok when wound is stable, which R2’s was not.” CMS Ex. 16 ¶ 13.  According to Dr. Berlowitz, R2’s wound was a “rapidly evolving injury.”  Id. ¶ 12.  I find CMS’s expert’s opinion credible because it is consistent with the rest of the record, including the notes about R2’s wound in the hospital.  Specifically, on April 27, one week after the wound was identified, the formal assessment noted that the depth of the wound was just less than 0.1 cm.  CMS Ex. 7 at 31.  One week later, on May 3, the resident’s wound became “very painful” as it had progressed to the bone and required surgery under general anesthesia.  Id. at 200-01.  Additional hospital notes indicate that “imaging has demonstrated osteomyelitis of the sacrum.”  Id. at 226.⁴  The rapid progression of the wound from a depth of 0.1 cm to reaching the bone, in just a week’s time is thus consistent with CMS’s expert’s opinion that the resident had a “rapidly evolving injury” and for that reason required more frequent assessments and measurements.

Petitioner also disputes the noncompliance finding by arguing the wound was, in fact, healing or improving.  P. Br. at 14.  In support, Petitioner cites the evaluation from April 27, which indicated that “wound healing is slow or stalled but stable, little/no deterioration.”  P. Br. at 14 (citing CMS Ex. 7 at 29).  The wound nurse also noted on the

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evaluation form that a worsening of the wound was anticipated until the slough tissue could be removed from the wound bed.  P. Br. at 14 (citing CMS Ex. 7 at 31).  However, the formal wound evaluation on April 27 was more equivocal than Petitioner paints it to be.  During the initial evaluation, the wound nurse measured the wound to have an area of 5.6 cm2 (3.3 cm length x 3.1 cm width) (depth inapplicable).  CMS Ex. 7 at 19.  But the April 27 evaluation found the wound to have an area of 11.7 cm2 (3.5 cm length x 4.4 cm width)—more than double the area.  CMS Ex. 7 at 26.  The wound nurse documented that the pressure injury “has increased in size extending to mid coccyx area.”  Id. at 31.  Additionally, I recognize that the wound nurse marked the April 27 evaluation form to indicate that the wound was “Slow to Heal:  wound healing is slow or stalled, but stable, little/no deteriorating.”  CMS Ex. 7 at 29.  But in that particular section of the evaluation form, there are only three pre-set prognoses to choose from:  (1) Healable (2) “Slow to Heal” (which is what the wound nurse marked) and (3) “Monitor/Manage:  Wound healing not achievable due to untreatable underlying condition.”  CMS Ex. 7 at 22, 29.  The limited—and therefore imprecise—options in that particular section of the form keep me from placing significant weight on the wound nurse’s selection.  Finally, the record shows that, on April 30, for the first time, the resident received pain medication (Tramadol) after she complained of pain to her buttocks.  CMS Ex. 7 at 53.  The balance of the record therefore does not show that the wound was ever healing or improving.

Luther Manor’s failure to assess and measure the wound every shift as directed by R2’s care plan caused more than minimal harm.  CMS submitted unrebutted expert opinion that “[a] wound, like R2’s, that progresses to the bone has a very high risk of becoming infected, which is likely to lead to serious injury and death.”  CMS Ex. 16 ¶ 15.  Indeed, the record supports that R2 was actually harmed, as the hospital documentation noted that the wound was “very painful,” and the resident eventually required surgery.  CMS Ex. 7 at 200-01.  For these reasons, Luther Manor was out of substantial compliance with the requirements to treat pressure injuries at 42 C.F.R. § 483.25(b)(1)(ii).

2. CMS’s finding of immediate jeopardy is not clearly erroneous.

CMS alleges that Petitioner’s violation of 42 C.F.R. § 483.25(b)(1)(i)-(ii) constituted an isolated instance of 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

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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).

Luther Manor argues that it was in substantial compliance and notes that it “did not cause a likelihood of serious injury or death when it properly assessed and treated R2’s wound.”  P. Br. at 10.  However, the record shows that Luther Manor did not measure R2’s wound as required by her care plan.  Dr. Berlowitz provided undisputed expert testimony that “[t]he wound’s progression to the bone would not have happened overnight” and that the wound’s progression “likely should have been observable by facility staff several days before [R2’s hospitalization] with a proper assessment.”  CMS Ex. 16 ¶ 13; see also CMS Ex. 16 ¶ 13 (“The facility should have recognized that ulcer went down to bone, but it did not detect this progression before R2’s discharge on May 3, 2021.”).  Given the wound’s “rapidly evolving” nature and how it doubled in size the first week, staff’s failure to measure the wound placed R2 at likely risk of serious harm.  The failure effectively allowed the wound to progress and foreclosed any opportunity for the wound nurse or physician to modify the treatment plan accordingly.  I find Dr. Berlowitz’s testimony to be credible and convincing.

Indeed, R2 eventually suffered serious harm as it is undisputed that R2’s wound progressed to the bone and required surgery.  CMS Ex. 7 at 226; CMS Ex. 16 ¶ 15 (“The facility’s failures in assessing the wound . . . allowed the pressure ulcer to worsen to the point that the wound needed to be surgically debrided (removing infected and dead tissue and her coccyx excised (removed).”).  Hospital documentation also supports that the wound was “very painful.”  CMS Ex. 7 at 201.

Given the evidence of the likelihood of serious harm and actual serious harm suffered by R2, the record supports CMS’s immediate jeopardy determination and Luther has not met its burden to show that the determination was clearly erroneous.

3. CMS has proven that Luther Manor was not in substantial compliance with 42 C.F.R. § 483.15(c)(7) (Tag F624).  

CMS argues that the facility failed to provide a safe discharge by discharging R2 to her daughter’s home where only one person was available to assist with transfers even though R2 required two people to assist.  CMS Br. at 12.  CMS also argues that the facility was required to “ensure that R2’s family could meet her medical needs at home before discharging her there” and that “this included ensuring that two people would be available to help her safely transfer.”  CMS Supp. Br. at 6; CMS Ex. 4 at 9-10.  In addition, CMS states that the facility “did not inquire, much less confirm, that two people would be available at the daughter’s home, when it discharged R2.”  CMS Br. at 12.  The SOD also notes that R2’s daughter was not invited to the discharge plan meeting, and when R2’s insurance terminated her benefits, the facility did not provide R2 with

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information about other programs that that might pay for her care at the facility.  CMS Ex. 4 at 6.

According to CMS, these facts support the facility’s noncompliance with the requirement at 42 C.F.R. § 483.15(c)(7), which provides that:  “A facility must provide and document sufficient preparation and orientation to residents to ensure safe and orderly transfer or discharge from the facility.  This orientation must be provided in a form and manner that the resident can understand.”

Petitioner argues that the deficiency cited under Tag F624 does not require a nursing home to ensure a family is qualified to meet the needs of the discharging resident.  P. Supp. Br. at 3-4.  According to Petitioner, its obligation pursuant to Tag F624 was solely to “‘orient and prepare [R2] regarding . . . her transfer or discharge in a form and manner that [R2] can understand’” or, otherwise, to explain the reason for the discharge to R2 and to assist in discharge preparations to minimize anxiety to R2.  P. Supp. Br. at 3-4.

The State Operations Manual (SOM) provides guidance which states:

Sufficient preparation and orientation means the facility informs the resident where he or she is going, and takes steps under its control to minimize anxiety.

Examples of preparation and orientation may include explaining to a resident why they are going to the emergency room or other location or leaving the facility; working with family or resident’s representative to assure that the resident’s possessions (as needed or requested by the resident) are not left behind or lost; and ensuring that staff handle transfers and discharges in a manner that minimizes anxiety or depression and recognizes characteristic resident reactions identified by the resident’s assessment and care plan.

The facility must orient and prepare the resident regarding his or her transfer or discharge in a form and manner that the resident can understand. The form and manner of this orientation and preparation must take into consideration factors that may affect the resident’s ability to understand, such as education level, language and/or communication barriers, and physical and mental impairments.

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SOM, App. PP at 168-69 (rev. 173 eff. Nov. 22, 2017). ⁵   The guidance instructs surveyors investigating this deficiency to “[a]sk [the] resident or his or her representative if they understand why the transfer or discharge occurred.”  SOM, App. PP at 169.

Here, the record shows that at least two weeks before the resident’s discharge, the facility explained to R2 that there was a plan to discharge her home with her daughter.  CMS Ex. 7 at 108.  The facility held another discharge meeting one week before the scheduled discharge date and again discussed the discharge plan, including continuing her therapy and nursing services with a home health agency.  CMS Ex. 7 at 69 (“Discharge plan will be to go home with daughter with PT/OT referral to be sent to Aurora at Home.”).  At that conference, R2 “informed [the interdisciplinary] team that [she] will speak with daughter [L] to confirm the pick-up time and will let [the interdisciplinary team] know.”  CMS Ex. 7 at 69.  Despite the plan to discharge R2 to her daughter’s home, the record shows that R2’s daughter was not invited to participate in any of the discharge planning meetings.  This is particularly concerning given the notes which described R2’s mental status as “confused” and noted her level of cognitive impairment as “some forgetfulness”.  CMS Ex. 7 at 106 and 110.  Additionally, it was noted that R2 was experiencing signs of short-term memory loss.  CMS Ex. 7 at 110.

On the date of R2’s discharge, the facility provided R2 written notice of her need for two people to assist with transfers.  CMS Ex. 7 at 195.  But there are no notes specifically documenting that staff discussed with R2 whether she would have two people to assist with her transfers.  At the discharge conference, staff documented the following:

Therapy is recommending PT/OT in home upon discharge with recommended 24/7 assistance from family member(s).  Resident confirmed that resident’s family does provide assistance throughout the day therefore this is not a concern.  Resident confirmed that resident lives with daughter [L] and husband currently resides in Arkansas.

CMS Ex. 7 at 69.  Although there is some ambiguity, the best reading of these notes is that staff discussed with the resident her need for 24/7 assistance and confirmed she did have 24/7 family support available, but that staff did not confirm whether R2 would have two people to assist with transfers at home.  There is no indication that the facility explained the risks to the resident of a discharge setting that does not meet her needs and no documentation that the resident understood her options and still chose to be discharged home.  SOM, App. PP at 223. There is also no indication that R2’s daughter, who was responsible for R2’s care immediately after discharge, was made aware of the need to have two people  to assist R2 upon discharge.

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The Board has  addressed what is required of a “safe and orderly discharge from a facility,” stating in pertinent part,  “…to prevent trauma that might be associated with transferring or discharging a resident home, a facility necessarily must consider factors that would affect whether the arrival home would be safe and orderly.”  Bartley Healthcare Nursing and Rehabilitation, DAB No. 2539 at 19 (2013).  Based on the circumstances surrounding R2’s discharge, I find that Petitioner did not provide sufficient preparation and orientation to ensure R2’s safe and orderly discharge from the facility.  The record as a whole therefore supports the facility’s noncompliance with the requirement to ensure a safe discharge from the facility.  For these reasons, I conclude that the facility was not in substantial compliance with the requirement at 42 C.F.R. § 483.15(c)(7).

4. The CMP amounts imposed, $7,030 per day from May 14, 2021 through May 25, 2021, and $540 per day from May 26, 2021 through June 28, 2021 are reasonable.

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).

In this case, CMS imposed a $7,030 per day CMP from May 14, 2021, through May 25, 2021, and $540 per day CMP from May 26, 2021 through June 28, 2021.  Luther Manor has not disputed the duration of the immediate jeopardy or noncompliance periods, but argues that CMS “remains opaque” in explaining how it calculates CMPs.  P. Supp. Br. at 3.   Petitioner also argues that CMS “refuses to explain the weight given to each cited deficiency and the facility’s compliance history in their [CMS’s] CMP calculations,” which, according to Petitioner, means that it “can only rely upon its records and

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testimony to assert the deficiencies cited . . . are unwarranted.”  P. Supp. Br. at 12; see also P. Supp. Br. at 3.

The Board has explained that “there is a presumption that CMS has considered the regulatory factors in setting the 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. 

Petitioner argues in favor of a per-instance penalty in the amount of $12,605 for this case.  In support, it relies on “CMS’s Analytical Tool⁶ ,” which includes recommended penalty amounts for a “G”-level deficiency (like the unchallenged deficiency cited under Tag F744) and a facility with a “three-year history of level 3 and 4 deficiencies.”  P. Supp. Br. at 12.

Contrary to Petitioner’s arguments, the regulations preclude a facility from appealing CMS’s choice of remedy, including the choice between a per day and a per instance CMP.  42 C.F.R. § 488.408(g)(2).  As the Board has explained, “because the ALJ conducts a de novo review, the ALJ is not to review whether CMS’s determination to impose a particular remedy was made correctly, but instead must make an independent determination of whether evidence presented on appeal supports the reasonableness of the amount of the CMP imposed.”  Mercy Home Care, Sioux City, DAB No. 3044 at 23 (2021) (citing W. Care Mgmt. Corp., DAB No. 1921 at 17 (2004)); Residence at Salem Woods, DAB No. 2052 at 11 (2006).  Considering the regulatory factors here, I conclude that the CMP amounts imposed are reasonable

The facility has not submitted evidence of its financial condition to show that a reduction of the CMP amounts is necessary to make them reasonable.  Coquina Ctr., DAB No. 1860 at 32 (2002).

With respect to the facility’s history of noncompliance, CMS has submitted evidence showing that during the December 2019 survey cycle, the facility was out of substantial compliance with the same requirement to treat pressure wounds (Tag F686).  CMS Ex. 3 at 1.  Although the prior deficiency was cited a lower scope and severity level E (pattern noncompliance that does not pose immediate jeopardy but has the potential for more than

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minimal harm), the repeat violation with the same regulation is significant and supports the CMP amounts in this case.  CMS Ex. 3 at 1.

The $7,030 per day CMP for the facility’s noncompliance with the requirement to treat pressure wounds is at the very end 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.  R2’s wound progressed rapidly to the bone, apparently without the facility’s awareness because staff failed to assess and measure the wound at every shift as required by the resident’s care plan.  The facility’s failure placed R2 at likely risk of infection, which would be serious, and indeed, the resident suffered actual serious harm as the wound was “very painful” at the hospital and required surgery.  The facility was also very culpable because assessing and measuring R2’s wound every shift was part of R2’s care plan and staff failed to carry out those orders.  These factors more than support the $7,030 CMP amount imposed.

The $540 per day CMP, which is towards the lower end of the range for non-immediate-jeopardy CMP amounts ($112 to $6,695), was imposed after the facility had abated immediate jeopardy conditions, but while its noncompliance continued for at least three deficiencies.  CMS Ex. 4 at 15 (stating that noncompliance with the requirement to treat pressure wounds continued at a scope and severity level of E while the facility continued to implement its action plan.); 85 Fed. Reg. at 2880.  The unchallenged deficiency cited under Tag F744, which involves noncompliance with 42 C.F.R. § 483.40(b)(3) and treating a resident with dementia, could support this lower-level CMP amount alone given that the noncompliance involved actual harm to a resident.  CMS Ex. 4 at 29; CMS Ex. 2 at 1.  The seriousness of the facility’s noncompliance with the requirement to treat pressure wounds and its culpability with respect to that deficiency have already been discussed above and apply here to support the lower-level CMP as well.  CMS Ex. 4 at 15.  Together, the seriousness of the affirmed deficiencies justifies the reasonableness of the lower CMP amount.  Given the factors discussed above, the $540 per day CMP amount is reasonable.

5. CMS was required by law to prohibit Luther Manor from having a NATCEP for two years.

Petitioner also challenged the loss of its NATCEP.  P. Br. at 21.  Given the facility’s noncompliance with the requirements discussed above, CMS had a basis for imposing a total CMP in excess of $11,160 and the facility was subject to a partial extended survey under section 1819(g)(2)(B)(i).  Act § 1819(f)(2)(B)(iii)(I)(c) (42 U.S.C. § 1395i-3(f)(2)(B)(iii)(I)(c)).  And, because Luther Manor met those conditions, the loss of the NATCEP was mandatory.  42 C.F.R. § 483.151(b)(2), (f).

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VIII.    Conclusion

Luther Manor was not in substantial compliance with the participation requirements at 42 C.F.R. §§ 483.25(b)(1) (Tag F686), 483.40(b)(3) (Tag F744), 483.10(e)(1), 483.12(a)(2) (Tag F604), and 42 C.F.R. § 483.15(c)(7) (Tag F624).  CMS’s determination that Luther’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.

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Endnotes

¹  Although the parties initially disputed whether a remedy had been imposed for the deficiency cited under Tag F624, both parties eventually addressed the deficiency on the merits and this decision will consider Luther Manor’s appeal of Tag F624.  P. Supp. Br. at 1-7; CMS Supp. Br. at 6-8.  As CMS alludes to in its brief, the September 2021 notice explained that “[the May 2021] survey revealed that your facility was not in substantial compliance” and that a list of remedies was being imposed “[a]s a result of the survey findings.”  CMS Ex. 2 at 1-2; CMS Supp. Br. at 7-8.

²  CMS increases the CMP amounts annually to account for inflation in compliance with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, Pub. L. No. 114-74, § 701, 129 Stat. 584, 599 (2015).  See 85 Fed. Reg. 2869 (Jan. 17, 2020).

³  Although the wound was documented as unstageable, the measurements of the wound during the two weekly formal assessments support that it was possible to measure the size of the wound, including length, width, and depth.

⁴  Luther attempts to discount the evidence that R2 had osteomyelitis by arguing that “the medical record does not confirm a diagnosis of osteomyelitis as this was only suspected by hospital admissions staff but not conclusively diagnosed.”  P. Br. at 18.  According to Luther’s expert, “the hospital did not make a definitive diagnosis of osteomyelitis as that would require an MRI and bone biopsy which was not done.”  P. Ex. 11 ¶ 8.  Nevertheless, whether the hospital made a definitive diagnosis of osteomyelitis is immaterial.  It is undisputed that the hospital staff suspected “osteomyelitis” which tends to support that the harm to R2 was serious, and it is also undisputed that R2 wound became “very painful” and ultimately required surgery.  CMS Ex. 7 at 200-01.

⁵  Available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017Downloads/R173SOMA.pdf (last visited Aug. 28, 2023)

⁶  CMP Analytic Tool, User’s Guide available at https://qcor.cms.gov/documents/CMP_Analytic_Tool_Users_Guide.pdf (last visited Aug. 28, 2023)