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                              Mercy Home Care, Sioux City, DAB CR5907 (2021)
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Mercy Home Care, Sioux City, DAB CR5907 (2021)








  
  
    

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





Mercy Home Care, Sioux City
(CCN: 16-7073),
Petitioner,

v.

Centers for Medicare & Medicaid Services
Docket No. C-21-885Decision No. CR5907July 21, 2021

        
              
    

      DECISION

Petitioner, Mercy Home Care, Sioux City, is a home health agency (HHA) with offices in Sioux City, Iowa, and Pender, Nebraska.  Petitioner participates in the Medicare program.  Following a revalidation survey revisit that was completed on August 31, 2016, the Centers for Medicare & Medicaid Services (CMS) determined that Petitioner was not in substantial compliance with Medicare conditions of participation for HHAs and imposed a per-day civil monetary penalty (CMP) of $6,000 for 69 days of noncompliance, for a total CMP of $414,000.  Petitioner requested an administrative law judge (ALJ) hearing to dispute the remedy imposed, at which time it did not dispute the determinations of noncompliance with 42 C.F.R. § 484.18(b) with respect to its care of Patient # 6 or that it remained out of compliance for a period of 69 days.  Based on this undisputed deficiency, I upheld the per-day CMP in a decision issued on November 15, 2018.  *Mercy Home Care, Sioux City*, DAB CR5211 (2018).  On July 1, 2021, the Departmental Appeals Board (DAB) affirmed Petitioner’s noncompliance with the condition of participation at 42 C.F.R. § 484.18, based on its noncompliance with 42 C.F.R. § 484.18(b), and also affirmed the determination that the noncompliance continued for 69 days.  The DAB remanded the matter “for further consideration of the reasonableness of the CMP.”  *Mercy Home Care, Sioux City*, DAB No. 3044 (2021).  I re-affirm the per-day CMP of $6,000.

**Page 2**

**I.     The DAB upheld the determinations that Petitioner did not comply with the condition of participation in 42 C.F.R. §** **484.181
 based on its noncompliance with the standard-level requirement at 42 C.F.R. §** **484.18(b) and that it remained out of compliance for 69 days.**

It is not necessary to re-state the previous decision in its entirety; that decision can be found at *https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2018/alj-cr5211/index.html* (last visited July 19, 2021).  Because the DAB remanded the matter for further consideration of the reasonableness of the CMP, specifically for the ALJ “to set out her rationale explaining why the absence of findings” relating to other deficiencies “does not materially affect or detract from her assessment of the reasonableness of the CMP,” it was unnecessary to solicit supplemental briefing or to make new evidentiary findings.  This matter is ready for the issuance of a new decision.

As relevant here, 42 C.F.R. § 484.18, which is the condition of participation addressing the acceptance of patients, plans of care, and medical supervision, requires that an HHA must follow a “written plan of care established and periodically reviewed by a doctor.”  The standard at 42 C.F.R. § 484.18(b) requires that an HHA’s professional staff “promptly alert the physician to any changes that suggest a need to alter the plan of care.”  The DAB upheld the factual findings listed below and I incorporate those findings herein:2

***1.  CMS presented prima facie evidence that, with respect to Patient #*** ***6, Petitioner failed to comply with 42 C.F.R. § 484.18, which is a condition of participation addressing the acceptance of patients, plans of care, and medical supervision.***

***2.  Petitioner’s briefing is silent regarding CMS’s allegation of noncompliance regarding Patient #*** ***6, and therefore, it has not rebutted CMS’s prima facie case by a preponderance of the evidence.***

***3.  Patient #*** ***6 had a care plan goal to demonstrate improved wound status, which would be evidenced, in part, by a decrease in size of the wound.***

***4.  On August 15, 2016, Petitioner recorded that Patient #*** ***6’s wound measured 4 cm by 9 cm by 1 cm, the surface area of the wound was 36 cm2, and the wound assessment tool (WAT) score was 23.***

**Page 3**

***5.  On August 22, 2016, Petitioner recorded that Patient #*** ***6’s wound measured 16.2 cm by 4 cm by 1 cm, the surface area of the wound was 64.8 cm2, and the WAT score was 37.***

***6.  Patient # 6 reported that her wound pain was a level 4 on August 20, 2016, and that her wound pain was a level 7 on August 22, 2016.***

***7.  Patient # 6’s plan of care required that Petitioner contact the attending physician if she had any condition changes.***

*********8.  Petitioner had a policy, Care Management and the Plan of Care, that required it to reevaluate a patient’s medical condition and the achievement or lack of achievement of goals and outcomes, and this policy required Petitioner’s clinicians to notify an attending physician of any condition changes and to make any physician-ordered changes to a patient’s plan of care.***

***9.  Petitioner submitted written testimony that the condition of a wound would not warrant special notification to an attending physician when, in the span of one week, the total surface area had been decreasing, the patient had no pain in the wound area, and the WAT score had decreased, which would evidence healing.  Patient # 6’s wound quadrupled in length, the surface area nearly doubled in size, the WAT score increased from 23 to 37, and she reported increased pain at the wound site.***

***10.  Patient # 6 had a change of condition.***

***11.  Petitioner did not notify Patient # 6’s physician of a change of condition after the August 22, 2016 visit by one of its clinicians, nor did it determine whether it was necessary for the physician to update Patient # 6’s plan of care to address her change of condition.***

***12.  Petitioner’s noncompliance involving Patient # 6 demonstrates noncompliance with the condition of participation at 42 C.F.R. § 484.18, and I need not address any other deficiencies cited under the same condition of participation.***

*Mercy Home Care,*DAB CR5211 at 4-5; *see Mercy Home Care,*DAB No. 3044 at 20.

**Page 4**

The previous decision explained that Patient # 6 had a primary diagnosis of infection following a surgical repair of an incarcerated hernia and had received 60 days of home health services for care of the wound after the surgery.  *Mercy Home Care*, DAB CR5211at 6.  The decision also explained that during the second 60-day course of treatment, Patient # 6’s wound *quadrupled*in length and nearly *doubled* in surface area.  *Id*. at 7, 9.  And although the wound had a “small” amount of serosanguinous discharge on August 20, 2016, only two days later a nurse documented a “large” amount of serosanguinous discharge.  *Id.*at 7.  Further, the WAT score, which assesses 13 separate factors, had increased from 23 to 37.  *Id.*at 7.Months after surgery, Patient # 6 reported a pain level of 7 on a scale of 10.  *Id.*at 7.  Despite the significant pain, increasing wound size, a large amount of serosanguinous discharge, and a double-digit increase of the WAT score, Petitioner reported, on August 22, 2016, “NONE” in response to a question on its wound care assessment form asking whether there had been a change in status of the wound.  *Id.*at 8.  Not only did Petitioner fail to recognize the worsening of the wound, but it did not notify Patient # 6’s physician, as required by both Patient # 6’s plan of care and its own Care Management and the Plan of Care policy.  *Id*. at 6, 8.

The decision determined that based on its noncompliance with 42 C.F.R. § 484.18(b),  Petitioner did not substantially comply with the condition of participation at 42 C.F.R. § 484.18 that requires an HHA be able to meet a patient’s medical needs at his or her place of residence.  *Id.*at 8.  The decision explained that the same condition of participation requires that a patient’s written plan of care be followed and reviewed by the physician, which necessarily would occur when HHA personnel “promptly alert the physician to any changes that suggest a need to alter the plan of care,” which is a standard for the condition.  *Id.*  The decision also discussed that not only did Petitioner not recognize Patient # 6’s change of condition, but it also failed to notify Patient # 6’s physician so that the plan of care could be reviewed and revised.  *Id.*at 8.  The decision explained that the deficiencies involving the care of Patient # 6, in and of themselves, demonstrated noncompliance with the entire condition of participation at 42 C.F.R. § 484.18.  The decision further noted that Petitioner had not disputed CMS’s determination that it did not return to compliance for 69 days.  *Id.*at 10.

***13.  The DAB upheld the determination that Petitioner remained out of compliance with a condition-level requirement for 69 days.***

***14.  CMS’s choice of remedy of a per-day CMP is not reviewable.***

***15. The DAB determined that the middle CMP range of $2,968 to $16,819, as adjusted for inflation, is applicable.***

***16.  The DAB determined that a per-day CMP of $6,000 is at the “low end” of the applicable inflation-adjusted CMP range.***

**Page 5**

***17.  A per-day CMP of $6,000 is in the bottom quartile of the applicable CMP range, and constitutes less than 36% of the maximum allowable middle-range CMP.***

***18.******CMS’s imposition of a per-day CMP of $6,000, at the low end of the applicable CMP range, is reasonable based on the deficiency involving Patient # 6, alone; if anything, a per-day CMP of $6,000 is unreasonably low based on the presence of multiple factors that individually support a per-day CMP of at least $6,000.***

The DAB “conclude[d] that the ALJ’s findings of fact concerning P6 supported a standard-level deficiency on which a condition-level deficiency may be found,” and that “[t]he ALJ properly found noncompliance with the condition of participation in section 484.18.”  *Mercy Home Care*, DAB No. 3044 at 20.  The DAB remanded the matter for further assessment of the evidence and reconsideration of the reasonableness of the CMP.  *Id.*at 21.  The DAB remarked that because “the ALJ confined her fact-finding to the wound care given to P6, the only patient Mercy did not address in its brief submitted to the ALJ, the ALJ did not reach the questions of whether Mercy’s arguments about rebutting CMS’s allegations on deficiencies affecting patients other than P6 had any merit and whether Mercy had put before the ALJ evidence about such other patients that could favor Mercy as it relates to the reasonableness question.”  *Id.*at 23.  The DAB further stated, “the ALJ should assess whether the resolution of some or all of the unaddressed deficiencies could materially affect a determination on the reasonableness of the CMP.”  *Id.*at 23.  The DAB also commented that “although the ALJ stated that ‘the nature, manner and degree of noncompliance’ as to the wound care given to P6 ‘would support a much higher penalty,’ ALJ Decision at 11, the ALJ did not sufficiently explain the basis for that statement.”  *Id*. at 24.

The DAB recognized that the applicable CMP range was $2,968 - $16,819.  *Id.*at 24; *see*42 C.F.R. § 488.845(b)(4) (middle range penalties “are imposed for a repeat and/or condition-level deficiency that does not constitute immediate jeopardy, but is directly related to poor quality patient care outcomes”); 45 C.F.R. § 102.3 (2016).

CMS’s choice of remedy (i.e., a per-day CMP) is not subject to review.  *See*42 C.F.R. § 488.845(h); *Mercy Home Care*, DAB No. 3044 at 23 (stating “the ALJ is not to review whether CMS’s determination to impose a particular remedy was made correctly”).  Because Petitioner did not challenge the 69-day duration of substantial noncompliance, the DAB determined that a per-day CMP would be applicable for a period of 69 days.  *Id.*at 25 (“If the $6,000 per-day CMP were found not reasonable in that circumstance and a lower per-day amount appropriate, the total CMP amount would be lower assuming noncompliance for 69 days (Mercy does not dispute this duration) . . . .”).  Thus, the ALJ’s role is to assess whether the *per-day* amount is reasonable, meaning, whether a

**Page 6**

per-day CMP of $6,000 is a reasonable enforcement remedy.3
  *Compare Mercy Home Care*, DAB CR5211 at 9 (Finding of Fact/Conclusion of Law # 13 that “CMS’s imposition of a per-day CMP of $6,000 is reasonable”) *with Mercy Home Care*, DAB No. 3044 at 9 (“The ALJ upheld the imposition of the $414,000 CMP.”).  An ALJ does not review the reasonableness of the CMP through the lens of whether the aggregate CMP (i.e., $414,000) is reasonable, but rather, reviews whether the per-day CMP is a reasonable enforcement remedy.  *See Mercy Home Care*, DAB No. 3044 at 23.

The DAB recognized that “the per-day CMP of $6,000 was at the low end of the middle range,” but it calculated that the $6,000 CMP is “more than double the lowest possible inflation-adjusted amount.”  *Id.*at 24-25.  The DAB’s calculation is correct, but I note that doubling a low number can still produce a low number, as happened here.  In fact, more than doubling the minimum CMP to $6,000 results in a CMP that is in the *bottom quartile*of the prescribed “middle range” between $2,968 and $16,819.  Likewise, a $6,000 CMP is less than *36%* of the maximum CMP for the “middle range.”  A low CMP in the bottom quartile of a CMP range is not unreasonably high for a “serious” and “repeated” deficiency that was “directly related to patient care.”  *Mercy Home Care*, DAB CR5211 at 10-11.  If anything, a “low end” CMP in the bottom quartile of the CMP range is unreasonably low.

CMS considers the following factors in selecting sanctions:  the extent to which deficiencies pose immediate jeopardy; the nature, incidence, manner, degree, and duration of deficiencies or noncompliance; the agency’s overall compliance history and the presence of repeat deficiencies; the extent to which deficiencies are directly related to the failure to provide quality patient care; the extent to which an agency is part of a larger organization with performance problems; and, an indication of any system-wide failure to provide quality care.  42 C.F.R. § 488.815(a)-(f).  In addition to the aforementioned factors, CMS also “takes into account the following factors” when assessing the amount of the penalty:  the size of an agency and its resources, accurate and credible sources that provide information on the operation and resources of the agency, and evidence regarding whether the agency has a “built-in, self-regulating quality assessment and performance improvement system” to address various performance, qualitative, health, and safety measures.  42 C.F.R. § 488.845(b)(1).

As explained by the DAB, it is presumed that CMS has considered the aforementioned regulatory factors.  *Mercy Home Care*, DAB No. 3044 at 21 (citing *Coquina Ctr.*, DAB No. 1860 at 32 (2002)).  In its June 5, 2017 brief, Petitioner did not address any of the regulatory factors addressed in 42 C.F.R. § 488.845(b)(1)(ii)-(iv).  Rather, Petitioner offered a terse and inaccurate discussion of the regulatory factors addressed in 42 C.F.R. § 488.815(a), (c), (d), and (f).  P. Br. at 21-22.  Notably, and specifically with respect to

**Page 7**

the deficiency involving Patient # 6, Petitioner did not address the regulatory factor at section 488.815(b) pertaining to “[t]he nature, incidence, manner, degree, and duration of the deficiencies or noncompliance.”  And Petitioner erroneously denied the presence of repeat deficiencies and that the deficiency at issue was “directly related to a failure to provide quality patient care.”  P. Br. at 21-22; *see*42 C.F.R. § 488.815(c)-(d).

Petitioner did not dispute the cited noncompliance involving Patient # 6.  I previously explained that this deficiency, in and of itself, supported the CMP, and I address it in greater detail below.  *See Mercy Home Care*, DAB CR5211 at 10 n.13 (“Petitioner’s failure to recognize that a complicated and previously infected surgical wound had significantly increased in size over a short period of time, along with its failure to notify the physician of this change in condition, is a serious deficiency that could have been upheld at the immediate jeopardy level.”); 11 (“As I have previously discussed, the nature, manner, and degree of the noncompliance support the penalty that was imposed at the low end of the penalty range,” and “[a]ny one of these factors under 42 C.F.R. § 488.815, alone, supports the per-day CMP of $6,000.”).

Although the other cited deficiencies were not insignificant, those deficiencies, even if substantiated, collectively paled in severity to the deficiency involving Patient # 6.  *See*CMS Ex. 1.  The single deficiency involving Patient # 6 was more egregious than any of the other cited deficiencies; Petitioner failed to recognize that Patient # 6, who was receiving a second 60-day course of care for a previously infected wound, had a worsening wound that had quadrupled in length, nearly doubled in surface area, developed a large amount of discharge, and caused a significant amount of pain, despite a plan of care goal that the wound decrease in size, have decreased drainage, and a decrease in pain.  *Mercy Home Care,*DAB CR5211 at 7.  The deficiency involving Patient # 6 alone supports the remedies imposed.  Even if Petitioner was in compliance with all other requirements identified in the statement of deficiencies, it gets no special credit for doing what it was always supposed to do.  The serious deficiency involving Patient # 6 *alone* supports a per-day CMP of $6,000, which is at the low end of the CMP range.

**II.     The CMP is reasonable.**

I address below why a per-day CMP of $6,000, which is at the low end of the applicable CMP range, is reasonable (if not unreasonably low) for a repeat deficiency in which Petitioner failed to recognize an increase in wound size, increased drainage, and increased pain, all contrary to the goals of Patient # 6’s plan of care, and also failed to notify her physician of this deterioration as required by the plan of care.

I first address the factors listed in 42 C.F.R. § 488.815:

**Page 8**

**42 C.F.R. §** **488.815(a)**:  Petitioner argued that the deficiency involving Patient # 6 was not cited at the immediate jeopardy level.  P. Br. at 21.  The previous decision stated that neither section 42 C.F.R. § 488.815(a) nor the associated CMP range (with a minimum per-day CMP of $17,808) is applicable.  *Mercy Home Care,*DAB CR5211at 10.

***19.  The nature, incidence, manner, degree, and duration of the deficiencies, pursuant to 42 C.F.R. §*** ***488.815(b), weigh in favor of a CMP above the minimum level.***

***20.  The deficiency involving Patient #*** ***6 was serious, in that Petitioner failed to recognize a worsening of Patient #*** ***6’s previously infected surgical wound that had quadrupled in length, increased in surface area, exhibited a large amount of serosanguinous discharge, sustained a significant increase in WAT score, and caused increased pain, and also involved a failure to notify Patient #*** ***6’s physician so that he could review and revise the plan of care.***

***21.  Petitioner’s noncompliance with respect to the care provided to Patient #*** ***6 followed a June 2016 survey that had identified noncompliance with the same participation requirement with respect to four out of 20 sampled residents.***

********42 C.F.R. §** **488.815(b)**:  Petitioner, in its brief, did not specifically address, with respect to the deficiency involving Patient # 6, “[t]he nature, incidence, manner, degree and duration of the deficiencies or noncompliance.”  I addressed this factor in my previous decision.  *Mercy Home Care,*DAB CR5211at 11 (“As I have previously discussed, the nature, manner, and degree of the noncompliance supports the penalty that was imposed at the low end of the penalty range.”).  I also addressed the severity of the deficiency involving Patient # 6, explaining that “Petitioner’s failure to recognize that a complicated and previously infected surgical wound had significantly increased in size over a short period of time, along with its failure to notify the physician of this change in condition, is a serious deficiency that could have been upheld at the immediate jeopardy level.”  *Id.*at 10 n.13.  The nature, manner, and degree of the noncompliance involving Patient # 6, alone, supports a $6,000 per-day CMP at the bottom quartile of the CMP range.

I also commented that “the nature, manner, and degree of noncompliance would support a much higher penalty.”  *Mercy Home Care*, DAB CR5211 at 11.  The DAB was not satisfied with this statement.  *Mercy Home Care*, DAB No. 3044 at 24 (stating “the ALJ did not sufficiently explain the basis for this statement”).  The condition-level requirement at 42 C.F.R. § 484.18 conveys expectations that a patient’s “medical, nursing, and social needs can be met adequately by the agency in [her home],” and the patient’s care follows a “written plan of care established and periodically reviewed by a doctor.”  42 C.F.R. § 484.18.  Patient # 6 had a previous 60-day course of home health

**Page 9**

services during which her surgical wound had been infected, and her primary diagnosis for the second 60-day course of home health services related to the previous wound infection.  *Mercy Home Care*, DAB CR5211 at 6.  Yet during this second 60-day course of care, Patient # 6’s wound increased in size (ultimately quadrupling in length and nearly doubling in surface area), the WAT score significantly increased from 23 to 37, serosanguinous discharge increased to a “large” amount, and the reported pain level increased to a 7 out of 10.  *Id.*at 7-8.  Petitioner neither recognized this worsening during the third post-operative month, nor did it recognize that Patient # 6 was not meeting the plan of care’s goals of a decreased wound size, decreased discharge, and decreased pain such that it should “promptly alert” the physician of any changes that suggested a need to alter the plan of care.  *See id.*at6; 42 C.F.R. § 484.18(b).  Based on these fundamental failures, it is unclear what, if any, benefit Petitioner’s home health services had on Patient # 6’s wound recovery.  Petitioner’s failures with respect to Patient # 6, alone, demonstrate an egregious failure to comply with the section 484.18(b) requirement.

Further, Petitioner’s noncompliance with 42 C.F.R. § 484.18(b) pre-dated the August 31, 2016 survey; in fact, the survey was a “45-day validation survey revisit” following the identification of other deficiencies involving the same participation requirement.  *Mercy Home Care*, DAB No. 3044 at 24; *see*CMS Ex. 1 at 1.  Despite the previous recent citation of noncompliance, Petitioner remained out of compliance, to the detriment of Patient # 6.

Even if Petitioner was in compliance with the other requirements that had been cited in the statement of deficiencies, which I previously explained paled in comparison to the deficiency involving Patient # 6, “the nature, manner, and degree of noncompliance” involving Patient # 6, which involved multiple failures, supports the low-end $6,000 CMP.

***22.  Petitioner was previously cited for noncompliance with 42 C.F.R. §*** ***484.18(b) in June 2016, and the presence of repeat deficiencies is an appropriate basis, pursuant to 42 C.F.R. §*** ***488.815(c), for a low-end CMP within the bottom quartile of the allowable range.***

**42 C.F.R. §** **488.815(c)**:  Petitioner erroneously claimed, without any elaboration, that “there are no repeat deficiencies.”  P. Br. at 21.  Addressing this misrepresentation in my previous decision, I remarked that Petitioner “appears to have overlooked that it was cited for noncompliance with the same condition (under multiple tags, to include G158, G159, G164, and G165) in a June 2016 survey, which is the reason why it was the subject of a revisit survey in August 2016.”  *Mercy Home Care*, DAB CR5211 at 11.  The DAB likewise addressed Petitioner’s erroneous claim, stating:

The evidence the ALJ cited, CMS’s exhibit 2, page 10, is the first page of a two-page summary of data from the June 2016 survey in chart form.  The

**Page 10**

chart summary indicates that noncompliance with five conditions of participation, 42 C.F.R. §§ 484.14, 484.18, 484.30, 484.48, and 484.55, were found; that various section 484.18 deficiency findings, cited under various tags, were noted as to several of 20 sampled patients; and, with respect to Tag G164 (“Periodic Review of the POC [plan of care] – failed to alert physician to need to change POC”) deficiency findings were noted with respect to four of 20 sampled patients.  CMS Ex. 2, at 10.  The [statement of deficiencies] states that the state agency conducted a “45-day validation survey revisit” at the end of August 2016 “following the condition level validation survey concluded” in June 2016 and that Mercy was found to have remained out of compliance with section 484.18.  *See*CMS Ex. 1, at 1; CMS Ex. 3 (written testimony of H.T., a registered nurse), at 1-2 (¶¶ 4, 5, 9, 10) (testifying that she was a member of the survey team for both the June and August surveys; although Mercy returned to compliance with four of the five conditions of participation as of August 2016, Mercy remained out of compliance as to Tags G156 and G164).  Thus, the record supports a history of noncompliance, at a minimum, with the standard-level condition in section 484.18(b), even the conclusion we have upheld regarding P6, that goes back to June 2016.  Before the [DAB], Mercy does not raise any specific dispute about this evidence of history of noncompliance.

*Mercy Home Care*, DAB No. 3044 at 24.  The DAB further stated that, upon remand, “the ALJ may further consider whether that history, in the context of subsequent (August 2016) revisit survey findings upheld by the ALJ, has a bearing on the overall nature, manner, and degree of the deficiencies and whether the deficiencies reflect a broader, system-wide failure to provide quality care.”  *Id.* at 24.

Petitioner failed to correct its earlier deficiencies.  Petitioner was on notice that it was not in compliance with 42 C.F.R. § 484.18(b) within the preceding two months, yet it still did not take the necessary steps to follow a written plan of care established and periodically reviewed by a patient’s physician.  *See*42 C.F.R. § 484.18(b).  Petitioner had a repeat deficiency involving the same participation requirement, and this factor, in and of itself, warrants a CMP significantly higher than the minimum level.  A low per-day CMP of $6,000, still within the bottom quartile of the middle CMP range, is entirely reasonable based on Petitioner’s failure to rectify its noncompliance.

***23.  Consistent with the ALJ decision, the DAB determined that the deficiency involving Patient #*** ***6 constituted inadequate patient care and adversely affected a patient’s health and safety.***

**Page 11**

***24.  Petitioner’s failure to provide adequate patient care and the resulting adverse impact on a patient’s health and safety warrant a CMP above the minimum level.***

**42 C.F.R. §** **488.815(d):**  Petitioner argued, again without elaboration, that “there is no evidence at all of any causal connection between any cited deficiency and deficient patient care.”  P. Br. at 21.  I reiterate that Petitioner failed to raise any arguments regarding the cited deficiency involving Patient # 6.  *See Mercy Home Care*, DAB No. 3044 at 21 (“However, in contrast, with respect to P6, the ALJ made findings that P6’s wound progressively *worsened –*facts Mercy does not dispute.”); 22 (“Mercy attempted to rebut CMS’s allegations, making arguments about every patient (other than P6) discussed in the survey findings concerning the condition of participation in section 484.18.”).  The DAB agreed that Petitioner failed to provide quality care to Patient # 6, stating:

Leaving P6’s wound changes unattended and unaddressed inconsistent with section 484.18(b) and Mercy’s care-planning policy provisions . . . could have further hampered P6’s post-surgical recovery process, causing her even more pain, and could have led to further complications, notably, infection, which evidently had manifested as indicated by changes in discharge noted at the wound site.  The findings not only constituted inadequate patient care but adversely affected a patient’s health and safety.  We therefore conclude that the ALJ’s findings of fact concerning P6 supported a standard-level deficiency on which a condition-level deficiency may be found.

*Id.*at 20; *see Mercy Home Care*, DAB CR5211 at 11 (“[T]his deficiency is undoubtedly and directly related to patient care.”).  Because the deficiency involving Patient # 6 is “directly related to a failure to provide quality patient care,” a CMP at the bottom quartile of the middle penalty range, yet still at the low end of that range, is undoubtedly reasonable, if not too low.  42 C.F.R. § 488.815(d).

**42 C.F.R. §** **488.815(e)**:  Petitioner did not address this factor, which is not otherwise raised by the evidence.

***25.  Petitioner’s failure to address its noncompliance with 42 C.F.R. §*** ***484.18(b) is an indication of a system-wide failure to provide quality care.***

**42 C.F.R. §** **488.815(f)**:  Petitioner argued “there are no [systemic] errors; to the extent that there are any errors by Mercy, they are isolated incidents, and nothing in the Statement of Deficiencies indicates that particular errors were widespread.”  P. Br. at 22.  The evidence shows that Petitioner’s noncompliance with 42 C.F.R. § 484.18(b) was not

**Page 12**

an isolated occurrence; the June 2016 survey determined that, with respect to four out of 20 sampled patients, Petitioner “failed to alert physician to need to change [plan of care].”  CMS Ex. 2 at 10.  This previous and recent noncompliance with the *same* standard was a basis for the August 2016 revisit survey.  CMS Exs. 1 at 1; 2 at 10.  The DAB acknowledged this factor could appropriately be considered as an indication of a system-wide failure to provide quality care.  *See Mercy Home Care*, DAB No. 3044 at 24 (“On remand, the ALJ may further consider whether . . . the deficiencies reflect a broader, system-wide failure to provide quality care.”).  The fact that Petitioner, after its noncompliance with respect to four of 20 sampled patients, remained out of compliance with 42 C.F.R. § 484.18(b), evidences a systemic problem with its provision of quality care.  Petitioner was on notice that a 45-day revisit survey would be performed based on, in part, the requirement at section 484.18(b), yet it still failed to identify the worsening of Patient # 6’s wound and notify the physician so that the plan of care could be reviewed and updated.  *See id.*at 19 (“Mercy did not show before the ALJ, and does not show before the [DAB], that Mercy’s nursing professionals recognized and noted the changes in P6’s wound and alerted a physician about them consistent with the regulatory standard or Mercy’s care-planning policy.”).  This systemic failure warrants a CMP higher than the minimum allowable CMP, and a CMP within the bottom quartile of the middle range, based on this factor alone, is reasonable.

***26.  Petitioner did not claim that CMS failed to adequately take into account any of the factors listed in 42 C.F.R. §*** ***488.845(b)(1)(ii)-(iv).***

******Petitioner did not claim a lack of resources or that CMS misapplied any other factor addressed in 42 C.F.R. § 488.845(b)(1)(ii)-(iv).  *See*P. Br. at 21-22.

***27.  I affirm the remedy imposed by CMS.***

Petitioner offered no defense to what can be viewed as the most significant deficiency detailed in the statement of deficiencies, and the same deficiency had been identified with respect to four of 20 sampled patients only weeks earlier.  The deficiency was serious, in that it involved an unrecognized worsening of the very wound that Petitioner was treating and monitoring through home health services.  Petitioner failed to recognize *multiple*signs of worsening (lengthening of the wound, increased surface area, increased discharge, increased WAT score, increased pain), and it failed to notify Patient # 6’s physician.  This deficiency is attributable to a failure to provide quality patient care, and Petitioner failed to correct its previous noncompliance with the requirement.  A $6,000 per-day CMP, which is at the *low end* of the middle range, is entirely reasonable.  Despite the presence of *several* factors that could individually support a significantly higher CMP, the per-day CMP imposed was within the bottom quartile of the allowable CMP range and less than 36% of the allowable maximum penalty for that range.  To the extent the per-day CMP of $6,000 is unreasonable, it is only because it is unreasonably low.  I reiterate that I may not impose a different remedy (i.e. a per-instance CMP), and

**Page 13**

Petitioner has not disputed that it remained out of compliance for 69 days.  Therefore, I uphold the per-day CMP of $6,000.

**Page 14**

IV.  Conclusion

I affirm CMS’s imposition of a per-day CMP of $6,000 because it is a reasonable enforcement remedy.


          /s/
        Leslie C. Rogall

                      Administrative Law Judge
      1. I reference 42 C.F.R. § 484.18 as it was in effect at the time of the surveys.  See 82 Fed. Reg. 4504, 4578 (Jan. 3, 2017). back to note 1
                      2. Findings of fact are in italics and bold font. back to note 2
                      3. Petitioner has not disputed the duration of the CMP, and the DAB upheld the 69-day duration of substantial noncompliance.  Mercy Home Care, DAB No. 3044 at 25. back to note 3 Back to top
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