Mercy Home Care, Sioux City, DAB CR5211 (2018)

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. CMS imposed a per-day civil monetary penalty (CMP) of $6,000 for 69 days of noncompliance, for a total CMP of $414,000. For the reasons discussed below, I affirm the remedies imposed.

I. Background

The Social Security Act (Act) sets forth requirements for HHA participation in the Medicare program. The Act authorizes the Secretary of the United States Department of Health and Human Services (Secretary) to promulgate regulations implementing those statutory provisions. 42 U.S.C. §§ 1395x(m), (o), 1395bbb. The Secretary's regulations are found at 42 C.F.R. pt. 484.HHA regulations were amended effective July 13, 2017, at which time various regulations were revised and redesignated, to include the condition of participation that was formerly listed at 42 C.F.R. § 484.18 and is the focus of this decision. 82 Fed. Reg. 4504 (Jan. 13, 2017). I refer to the regulatory conditions of participation that were in effect at the time of the survey and imposition of the CMP in 2016. Further, CMS revised the Automated Survey Processing Environment (ASPEN) tags for each condition and standard for participation in January 2018; Tags G158, G159, and G164, which are referenced herein, have been redesignated and revised in the current version of Appendix B of the State Operations Manual. See QSO-18-13-HHA (January 12, 2018). https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/QSO-18-13-HHA-.pdf, last visited November 2, 2018.

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In order to participate in the Medicare program, an HHA must meet all conditions of participation specified in 42 U.S.C. § 1395bbb(a) and 42 C.F.R. §§ 484.10 through 484.115. 42 U.S.C. § 1395x(o)(6). CMS enters into agreements with state survey agencies, and these local survey agencies determine compliance with conditions of participation. 42 C.F.R. §§ 488.10, 488.11, 488.26. As relevant here, CMS "may impose a civil monetary penalty against an HHA for either the number of days the HHA was not in compliance with one or more conditions of participation or for each instance that an HHA is not in compliance, regardless of whether the HHA's deficiencies pose immediate jeopardy." 42 C.F.R. § 488.845(a)(1). An HHA may request a hearing before an administrative law judge (ALJ) to dispute the imposition of a CMP. 42 C.F.R. § 488.845(c)(2)(i).

On appeal to an ALJ, CMS must make a prima facie case that the HHA failed to comply substantially with federal participation requirements and, if shown, the "burden [is] on [an HHA] to demonstrate compliance with the identified conditions by the preponderance of the evidence in the record." Nightingale Home Healthcare, Inc., DAB No. 2784 at 11 (2017). An ALJ hearing is a de novo proceeding. See, e.g., Jewish Home of Eastern Pa., DAB No. 2380 at 7-8 (2011).

The Iowa Department of Inspections and Appeals, Health Facilities Division, completed a revisit survey on August 31, 2016, following a revalidation survey, at which time it determined that Petitioner continued to not be in compliance with 42 C.F.R. § 484.18 (Acceptance of patients, plan of care, and medical supervision), which is a condition of Medicare participation. CMS Exhibit (Ex.) 1 at 1.

In a letter dated November 28, 2016, CMS informed Petitioner that it was imposing a $6,000 per-day CMP based on the noncompliance cited in the statement of deficiencies following the first revisit survey completed on August 31, 2016. November 28, 2016 letter (Departmental Appeals Board Electronic Filing Docket entry # 1a.). The letter informed Petitioner that, based on a second revisit survey on November 7, 2016, it had returned to compliance as of the date of the second revisit survey.

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On January 20, 2017, Petitioner requested a hearing. Pursuant to my Acknowledgment and Pre-Hearing Order (Pre-Hearing Order), CMS submitted a pre-hearing briefCMS's brief consists largely of a regurgitation of the statement of deficiencies, and CMS did not provide a single citation to the documentary record that was relied upon by CMS and the surveyors. Further, CMS invokes summary judgment in the conclusory two sentences of its brief, yet did not style its pre-hearing submission as a motion for summary judgment or include such a motion in its pre-hearing submission. (CMS Br.) and three proposed exhibitsCounsel for CMS submitted, as CMS Ex. 2, a 415-page dump of a variety of records consisting of surveyor documents, reports prepared by Petitioner, facility policies, and care records for 12 different patients, despite the instruction in Section 6 of my Pre-Hearing Order that exhibits should be filed as separate documents and that multiple documents should not be uploaded as one file. I am not the first ALJ to express frustration with this particular counsel. See Consolid. Home Health, DAB CR4923 at 4 n.2 (2017) ("CMS counsel unhelpfully and unprofessionally grouped all of the survey documents and medical records for each of the surveys conducted in this case under two exhibit numbers .... The records for each patient ought to have been made separate exhibits and, by listing those individual exhibits on the exhibit list, Petitioner and I could have located documents relevant to each deficiency expeditiously, rather than rummaging through large exhibits."). (CMS Exs. 1-3). Petitioner, through its counsel, filed a pre-hearing brief and motion for summary judgment (P. Br.), along with twelve exhibits (P. Exs. 1‑12).CMS did not file a response to Petitioner's motion for summary judgment. Neither party has requested an opportunity to cross-examine any witnesses at a live hearing, and therefore, a hearing for the purpose of cross-examination of witnesses is unnecessary.As a hearing is unnecessary, I need not rule on Petitioner's motion for summary judgment and will decide this case on the merits. Pre-Hearing Order, §§ 8-10.

II. Issues

1. Whether Petitioner failed to comply with a condition of participation in the Medicare program;
2. Whether CMS had a legitimate basis to impose a CMP; and
3. Whether a CMP in the amount of $6,000 per day is reasonable.

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III. Findings of Fact and Conclusions of Law, and AnalysisFindings of fact and conclusions of law are in italics and bold font.

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.

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

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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.

With respect to the condition of participation for "Acceptance of patients, plan of care, and medical supervision," 42 C.F.R. § 484.18, the statement of deficiencies includes the following discussion regarding Patient # 6:

Patient # 6 had a start of care date of 6/10/16 and received skilled nursing services from the Pender, Nebraska branch office.

The patient's Plan of Care, dated 8/9/16 to 10/7/16, included physician orders for skilled nursing visits 3 times weekly for one week, twice weekly for one week and three times weekly thereafter to assess the patient's abdominal surgical wound and change the dressing to the wound. The patient's clinical records included the following:

a. The clinical record included a Skilled Nurse Visit Note, dated 8/15/16. The Note included wound measurements of the abdominal wound. The wound measured 4 centimeters (cm) long by 9 cm wide by 1 cm deep.

b. The clinical record included a Skilled Nurse Visit Note, dated 8/22/16. The Note included wound measurements of the abdominal wound. The wound measured 16.2 cm long by 4 cm wide by 1 cm deep. The length of the wound increased from 4 cm to 16.2 cm in one week.

c. The patient's clinical record lacked documentation of any contact with the patient's physician to report the increased length of the wound.

CMS Ex. 1 at 15-16. In its brief, CMS succinctly addressed this deficiency, which was cited under Tag G164 (Prompt notification of physician to any changes that suggest a

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need to alter the plan of care), arguing that "[t]he length of his [sic] wound increased from 4 cm on August 15, 2016, to 16 cm on August 22, 2016."CMS incorrectly uses the male gender in its discussion of Patient # 6. CMS Br. at 9. Relying solely on the statement of deficiencies, CMS charged that Patient # 6's clinical record "lacked documentation of any contact with the patient's physician to report the 400% increase in length of the wound." CMS Br. at 9-10. Petitioner offered no response to this allegation. P. Br.

Petitioner has a policy, Wound Measurements and Assessment, that instructs, inter alia, that all wounds should be measured "at least weekly with dressing changes." CMS Ex. 2 at 34. Petitioner's policy directs that wound length is measured in centimeters from "head to toe" at the longest points on a vertical plane, and width of a wound is measured in centimeters from "side to side" at the widest point on a horizontal plane. CMS Ex. 2 at 34. The policy directs its clinicians to document any signs of wound infection, with signs including "erythema, induration, purulent or increased drainage, color changes, odor, pain or fever." CMS Ex. 2 at 34.

Petitioner's policy, Care Management and the Plan of Care, instructs that "[d]uring visits and other client contacts, the clinician regularly reevaluates the client's medical condition, psychosocial status, home environment and the achievement or lack of achievement of goals and outcomes." CMS Ex. 2 at 20. The policy requires that "[d]uring an episode of care, clinicians notify the physician about condition changes, and make physician-ordered changes to the plan of care (in consultation with the client)." CMS Ex. 2 at 20. Likewise, the policy directs that "[c]linicians working with the client identify changes in client condition that necessitate changes to the plan and notify the physician to obtain updated orders." CMS Ex. 2 at 20. Further, the policy instructs that its clinician will contact the attending physician "whenever" a patient has "condition changes" or the plan of care needs to be changed. CMS Ex. 2 at 24.

An HHA must follow a "written plan of care established and periodically reviewed by a doctor . . . " in order to comply with 42 C.F.R. § 484.18, which is the condition of participation addressing acceptance of patients, plans of care, and medical supervision. One of the standards for that condition requires that HHA professional staff "promptly alert the physician to any changes that suggest a need to alter the plan of care." 42 C.F.R. § 484.18(b) (Periodic review of plan of care).

Patient # 6 was a 67-year-old woman who had a primary diagnosis of infection following a surgical procedure. CMS Ex. 2 at 285. Patient # 6 had surgical repair of an incarcerated hernia in June 2016, and received 60 days of home health services for care of the wound after the surgery. CMS Ex. 2 at 321. Nonetheless, the wound became infected, and Petitioner established a new plan of care for another 60 days, beginning August 9, 2016. CMS Ex. 2 at 321. The August 2016 plan of care directed that

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Petitioner assess and evaluate co-morbid conditions, "including wound care and other conditions that present themselves," in order "to identify changes and intervene to minimize complications." CMS Ex. 2 at 321 (capitalization omitted). The plan of care directed that Patient # 6 "will demonstrate improved wound status as evidenced by a decrease in size/drainage of wound, absence of infection, and decreased pain." CMS Ex. 2 at 321 (capitalization omitted). Patient # 6's plan of care instructed that a skilled nurse will report significant changes in status to the physician for early intervention. CMS Ex. 2 at 322.

On August 15, 2016, Petitioner sent a registered nurse to visit Patient # 6. The nurse assessed Patient # 6's wound, and reported there was no change in status of the wound, which measured 4 cm in length, 9 cm in width, and 1 cm in depth. The surface area of the wound was 36 cm², and the WAT score was 23.Petitioner submitted the written testimony of Barbara A. Samson, RN, MSN, who serves as Director of Clinical Services for Trinity Home Health Services. Ms. Samson testified that a "WAT score" refers to a standard “Wound Assessment Tool." P. Ex. 11 at 2. She explained that a WAT "measures thirteen separate factors including length, width, depth, surface area (in cm²), surface area score, depth description, granulation tissue, edges, exudate type, exudate amount, epithelialization, necrotic tissue type, necrotic tissue amount, skin color surrounding wound, peripheral tissue edema, peripheral tissue induration, and undermining." P. Ex. 11 at 2-3. Ms. Samson testified that nurses use a WAT score "to objectively evaluate and trend a patient's wound healing status." P. Ex. 11 at 3. She explained that the “lower the score, the better the wound is," and that "a higher score reflects deterioration in the wound." P. Ex. 11 at 3. The nurse reported that Patient # 6 reported pain at a level of 6 at the wound site, and that there was moderate bloody discharge. P. Ex. 6 at 65, 98-99.

A licensed practical nurse for Petitioner visited Patient # 6 on August 20, 2016. P. Ex. 6 at 108. The nurse did not record wound measurements because they were not due to be taken at that visit. P. Ex. 6 at 108. Patient # 6 reported that her pain at the wound site was at level 4, and the nurse documented that the wound had a small amount of serosanguineous discharge. P. Ex. 6 at 108.

Petitioner sent a registered nurse to visit Patient # 6 on August 22, 2016, at which time the nurse recorded that Patient # 6's wound was 16.2 cm in length, 4 cm in width, and 1 cm in depth. P. Ex. 6 at 65, 116. The surface area of the wound was 64.8 cm2, and the WAT score was 37. A large amount of serosanguineous discharge was observed from the wound, and Patient # 6 reported a pain level 7 at the wound site. P. Ex. 6 at 65, 116‑17. Despite the significant increase in the length of the wound and increases in the surface area and WAT score, along with the increased pain and large amount of

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serosanguineous discharge, the nurse reported there was no change in the status of the wound. P. Ex. 6 at 116.

Petitioner's policy required that it reevaluate a patient's medical condition and "lack of achievement of goals and outcomes," and that it "identify changes in client condition that necessitate changes to the plan of care and notify the physician to obtain updated orders." CMS Ex. 2 at 20. And even though Patient # 6 had a goal of demonstrating improved wound status, which specifically included a decrease in size of the wound, decreased drainage of the wound, an absence of infection, and decreased pain (CMS Ex. 2 at 321), Petitioner did not inform Patient # 6's physician that there was a "a lack of achievement of goals and outcomes," nor did it inform the physician of the increased size of the wound, along with the increased pain and drainage.Petitioner's policy identifies purulent or increased drainage, along with pain, as symptoms of infection. CMS Ex. 2 at 34. And even though Patient # 6's plan of care required that Petitioner assess and evaluate the wound and "identify changes and intervene to minimize complications," Petitioner reported on August 22, 2016, the response of "NONE" in response to a question on its wound care assessment form asking whether there had been a change in status of the wound. P. Ex. 6 at 116. Petitioner failed to recognize a worsening of the wound over the course of a week, and this failure is even more remarkable because Patient # 6 had suffered from a prior infection of the same wound, and was undergoing her second 60-day course of skilled home care to treat the wound. CMS Ex. 2 at 321. Because it failed to recognize the change in status of this wound, Petitioner did not notify the physician of a change of condition. As a result, Patient # 6's physician was not given an opportunity to update the plan of care to address this condition.

The pertinent condition of participation requires that an HHA be able to meet a patient's medical needs at his or her place of residence. 42 C.F.R. § 484.18. The condition of participation further requires that a patient's written plan of care is followed and is 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. 42 C.F.R. § 484.18. Petitioner, by not recognizing a change of condition, nor contacting the physician about the change of condition so that the plan of care could be reviewed and revised, as necessary, did not comply with the condition of participation listed under 42 C.F.R. § 484.18. I conclude that Petitioner was not in compliance with 42 C.F.R. § 484.18.

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.

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The deficiency cited above, in and of itself, is sufficient to demonstrate noncompliance with the entire condition of participation at 42 C.F.R. § 484.18. Petitioner failed to recognize a change in the status of a wound, even though the wound, which had a history of a prolonged course of healing and prior infection, quadrupled in length, nearly doubled in surface area, and had an increase in WAT score from 23 to 37 in the span of a week. Further, Petitioner failed to contact Patient # 6's physician, even though its own policy, and Patient # 6's plan of care, required notification in such an instance. This deficiency, alone, demonstrates noncompliance with this condition of participation. Therefore, I will not address the other deficiencies cited under Tags G158, G159, and G164.

13. CMS's imposition of a per-day CMP of $6,000 is reasonable.

A CMP in the "middle range" of penalties is warranted when there is a deficiency involving structure and process that is directly related to patient care outcomes. The middle range of penalties, prior to inflation adjustment, ranged from $1,500 to $8,500 per day.The proposed rulemaking included a table of per-day CMPs "for illustrative purposes only," that listed a per-day CMP of $5,000 for first-time deficiencies and a per-day CMP of $8,500 for repeat deficiencies involving 42 C.F.R. § 484.18. 77 Fed. Reg. 41,548, 41,583 (July 13, 2012). The CMPs referenced in the rulemaking do not include an adjustment for inflation. 42 C.F.R. § 488.845(b)(4). However, at the time the CMP was assessed on November 28, 2016, the inflation-adjusted CMP ranged from $2,968 to $16,819 per day.The cost-of-living adjustment was mandated pursuant to the Federal Civil Penalties Inflation Adjustment Improvements Act, P.L. 114-74, which was enacted on November 2, 2015. The Secretary determined that the new CMP amounts would apply to any CMP imposed on or after September 6, 2016, regardless of the date of the survey, so long as the noncompliant conduct occurred on or after November 2, 2015. See S&C: 16-40-NH/HHA/CLIA (September 8, 2016), https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-16-40.pdf, last visited November 2, 2018; 81 Fed. Reg. 61,538 (discussing that the law "provides a clear formula for adjustment of the civil monetary penalties, leaving agencies little room for discretion," and that the increased penalties will apply to "penalties assessed after August 1, 2016, whose associated violations occurred after November 2, 2015, the date of the enactment of the 2015 Amendments."). The inflation-adjusted CMPs are applicable, as the survey occurred on August 30-31, 2016, and the CMP was imposed on November 28, 2016. 81 Fed. Reg. 61,538, 61,555 (Sept. 6, 2016). CMS imposed a per-day CMP of $6,000 per day, which is at the low end of that range.

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A per-day CMP continues until compliance can be determined based on a revisit survey. 42 C.F.R. §§ 488.845(d)(4)(ii), (e)(1). Petitioner returned to compliance at the revisit survey on November 7, 2016, and therefore, the CMP remained in effect for 69 days. Petitioner has not disputed the duration of the CMP.

Additional regulatory factors may be considered in determining the appropriate amount of a CMP. 42 C.F.R. § 488.845(b)(1). These factors include: 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 its November 28, 2016 letter, CMS stated: "Please see 42 [C.F.R. §§] 488.815 and 488.845(b) regarding the factors CMS must consider when setting the amount of the civil monetary penalty ...." Thus, CMS identified the regulatory factors that it considered when determining the CMP. Further, CMS offered Petitioner an opportunity to submit evidence that should be considered to determine the amount of the CMP, yet Petitioner did not submit the requested evidence.

Petitioner argues that "[a]lthough the November 28, 2016 notice to Mercy cites to 42 C.F.R. § 488.815, there is no discussion of the scope and severity criteria set out in 42 C.F.R § 488.404, which describes the factors to be considered when CMS selects a remedy based on noncompliance . . . . " P. Br. at 21. Contrary to Petitioner's arguments, section 488.404 is irrelevant because it applies to penalties involving long-term care facilities and not HHAs.

Petitioner further argues there "is no evidence of immediate jeopardy to health and safety, and no immediate patient harm." P. Br. at 21. Petitioner is correct that it was not cited for any deficiencies at the immediate jeopardy level.Although the issue of immediate jeopardy is not before me, I note 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 of condition, is a serious deficiency that could have been upheld at the immediate jeopardy level. If the noncompliance had been cited at the immediate jeopardy level, then a much higher CMP, of no less than $17,808 per day, would be applicable pursuant to 42 C.F.R. § 488.845(b)(3). 81 Fed. Reg. 61,538. Because the deficiency was not cited at the immediate jeopardy level, the CMP range of $2,968 to $16,819 is applicable.

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Petitioner also argues, without specificity, that "the facts in this case fall well short of the factors set out in Section 488.815, and as a result CMS does not have a basis to impose a civil monetary penalty on Mercy." P. Br. at 21. Petitioner is again mistaken. 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. In fact, the nature, manner, and degree of noncompliance would support a much higher penalty, and would even support a per-day CMP of $6,000 based on the CMP range of $1,500 to $8,500 that preceded inflation adjustment. 42 C.F.R. §§ 488.815, 488.845(b)(4). Petitioner further argues that "there are no repeated deficiencies," yet it 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. CMS Ex. 2 at 10; see 42 C.F.R. § 488.815(c). I note that the factor listed at section 488.815(d) involves the extent to which deficiencies are directly related to a failure to provide quality patient care. Addressing this factor, Petitioner argues "there is no evidence at all of any causal connection between any cited deficiency and deficient patient care." P. Br. at 21. However, Petitioner failed to identify Patient # 6's change of condition and did not notify the physician of this change of condition; this deficiency is undoubtedly and directly related to patient care.I reiterate that Petitioner failed to address this particular allegation in its brief. Any one of these factors under 42 C.F.R. § 488.815, alone, supports the per-day CMP of $6,000.

Petitioner fails to raise any specific arguments that a CMP of $6,000, which is at the low end of the penalty range, is not reasonable pursuant to 42 C.F.R. § 488.845(b). The per-day CMP of $6,000 is reasonable, and the duration of the CMP is not challenged by Petitioner.

IV. Conclusion

I affirm CMS's imposition of a CMP, and I conclude that the per-day CMP of $6,000 is reasonable.