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                              Associated Homecare, Inc., DAB CR5372 (2019)
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Associated Homecare, Inc., DAB CR5372 (2019)








  
  
    

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





Associated Homecare, Inc.,
	(CCN: 157249),
	Petitioner,
v.
Centers for Medicare & Medicaid Services.
Docket No. C-17-362Decision No. CR5372July 24, 2019

        
              
    

      DECISION
The Centers for Medicare & Medicaid Services (CMS) imposed on Associated Homecare, Inc. (Petitioner or Associated) per-day civil money penalties (CMPs) totaling $722,500 for Petitioner’s alleged noncompliance with Medicare conditions of participation from July 22 through December 19, 2016.  Among other things, CMS found that Petitioner’s alleged noncompliance posed immediate jeopardy to Petitioner’s patients from July 22 through August 18, 2016.  Petitioner requested a hearing to challenge the noncompliance findings and CMPs.  However, in its brief, Petitioner challenges only the alleged immediate jeopardy-level noncompliance and the CMP related to that noncompliance.  Petitioner does not challenge CMS’s evidence or allegations that Petitioner was noncompliant from August 19 through December 19, 2016, or the CMPs that CMS imposed for that period.  As explained more fully below, the evidence establishes that Petitioner was noncompliant with Medicare conditions of participation from July 22 through December 19, 2016, and Petitioner has not carried its heavy burden to show that the finding of immediate jeopardy is clearly erroneous.  I therefore conclude that CMS had a basis to impose on Petitioner CMPs totaling $722,500.
**Page 2**
I. Background and Procedural History
Associated is a home health agency (HHA) located in Valparaiso, Indiana, that participated in Medicare.  CMS Exhibit (Ex.) 1.  From July 7 through 22, 2016, a surveyor for the Indiana State Department of Health (state agency) conducted a survey of Associated in response to a complaint.  CMS Ex. 1 at 1; CMS Ex. 25 at 1.  The state agency found that Associated was not in compliance with Medicare conditions of participation and that the noncompliance with one of those conditions constituted immediate jeopardy.  CMS Ex. 1 at 1; CMS Ex. 25 at 1, 3-4.  On August 19, 2016, the state agency conducted a revisit survey of Associated.  CMS Ex. 1 at 7; CMS Ex. 26 at 1.  The state agency found that Associated had removed the immediate jeopardy conditions as of August 19, 2016, but had not corrected the other condition-level noncompliance identified during the July 22, 2016 survey and remained out of compliance with Medicare conditions of participation.  CMS Ex. 1 at 7; CMS Ex. 26 at 1-3.  On October 28, 2016, the state agency completed a second revisit survey of Associated, finding that Associated remained out of compliance with Medicare conditions of participation.  CMS Ex. 1 at 14; CMS Ex. 97 at 1.  On January 27, 2017, the state agency completed a final revisit survey of Associated, finding that, effective December 20, 2016, Associated had resumed substantial compliance with all Medicare conditions of participation.  CMS Ex. 1 at 19; CMS Ex. 98 at 1.1
Based on the surveys, CMS made the following determinations:
From July 22 through October 27, 2016, Associated failed to comply with the conditions of participation at 42 C.F.R. §§ 484.10 (Tag G100) and 484.18 (Tag G156);2
	From July 22 through August 18, 2016, Associated’s noncompliance with 42 C.F.R. § 484.10 (Tag G100) posed immediate jeopardy to the health and safety of its patients;**Page 3**
From July 22 through December 19, 2016, Associated failed to comply with the conditions of participation at 42 C.F.R. §§ 484.30 (Tag G168), 484.36 (Tag G202), 484.48 (Tag G235), and 484.55 (Tag G330); and
	Effective December 20, 2016, Associated returned to substantial compliance with all conditions of participation.CMS Ex. 1 at 1, 7, 14, 19; CMS Ex. 25 at 1, 3, 40, 60, 79, 81-82, 84; CMS Ex. 26 at 3-9; CMS Ex. 97 at 1, 10, 20, 25, 28; CMS Ex. 98 at 1.  Based on these determinations, CMS imposed on Associated the following CMPs:3
A CMP of $8,500 per day effective July 22 through August 18, 2016, for a total of $238,000;
	A CMP of $2,000 per day effective August 19 through October 27, 2016, for a total of $140,000; and
	A CMP of $6,500 per day effective October 28 through December 19, 2016, for a total of $344,500.CMS Ex. 1 at 1, 8-9, 14-15, 20.
By letters dated October 3, 2016, November 17, 2016, and February 10, 2017, Petitioner requested hearings to challenge the notices of remedies issued by CMS.4
  By order dated October 7, 2016, (Pre-hearing Order) I acknowledged Petitioner’s October 3, 2016 hearing request and established a briefing schedule.  In subsequent orders dated November 21, 2016, and February 15, 2017, I acknowledged Petitioner’s November 17, 2016 and February 10, 2017 hearing requests, consolidated them under one docket number, and extended the briefing schedule.  In accordance with the schedule I set, CMS and Petitioner filed pre-hearing exchanges, including pre-hearing briefs (CMS Br. and P. Br., respectively), exhibit and witness lists, and proposed exhibits.  Within their pre‐hearing briefs, each party moved for summary judgment.  CMS submitted 111 exhibits (CMS Exs. 1-111), and Petitioner submitted nine exhibits (P. Exs. 1-9).  As neither party has objected to any of the proposed exhibits, I admit all of them into the record.
**Page 4**
Neither party requested to cross-examine the other’s witnesses.  Pre-hearing Order ¶ 9; CRDP § 14(e).5
  Therefore, although both parties have moved for summary judgment, I decide this case based on the written record, without regard for whether the standards for summary judgment are met.  Pre-hearing Order ¶¶ 10, 13; CRDP § 19(b), (d).  I deny both parties’ motions for summary judgment as moot.
II. Issues
The issues in this case are:
Whether Petitioner failed to comply with any Medicare conditions of participation;
	If Petitioner failed to comply with any conditions of participation, then whether CMS’s determination that Petitioner’s noncompliance with 42 C.F.R. § 484.10 (Tag G100) posed immediate jeopardy to patient health and safety is clearly erroneous; and
	Whether the imposed CMPs are reasonable.III. Jurisdiction
I have jurisdiction to hear and decide this case.  Social Security Act (Act) §§ 1891(f)(2)(A), 1128A(c)(2) (codified at 42 U.S.C. §§ 1395bbb(f)(2)(A), 1128a‐7a(c)(2)); 42 C.F.R. §§ 488.845(c)(2)(i), 498.3(b)(13).
IV. Discussion
**A. Applicable Legal Authority**
The Social Security Act (Act) sets forth requirements for HHAs to participate in Medicare and authorizes the Secretary of Health and Human Services (Secretary) to promulgate regulations implementing the statutory provisions.  Act §§ 1861(m), (o);
**Page 5**
1891 (42 U.S.C. §§ 1395x(m), (o); 1395bbb).6
  The Secretary’s regulations governing HHA participation in Medicare are found at 42 C.F.R. part 484.
In order to participate in Medicare and obtain reimbursement for services provided to beneficiaries, an HHA must comply with all applicable conditions of participation specified in Act § 1891(a) (42 U.S.C. § 1395bbb(a)) and 42 C.F.R. part 484.  Act § 1861(o)(6) (42 U.S.C. § 1395x(o)(6)).  A “condition of participation” represents a broad category of home health services.  Each condition is contained in a single regulation, which is divided into subparts called standards.  42 C.F.R. pt. 484.  Compliance with a condition of participation is determined by the manner and degree to which the provider satisfies the standards within the condition.  42 C.F.R. § 488.26(b).  If deficiencies are of such character as to “substantially limit the provider’s . . . capacity to furnish adequate care or which adversely affect the health and safety of patients,” the provider is not in substantial compliance with the conditions of participation.  42 C.F.R. § 488.24(b).  If the HHA fails to meet even one condition of participation or to comply with the provisions of section 1861, CMS may terminate its program participation or impose an “alternative sanction,” including a CMP.  Act §§ 1866(b)(2)(B), 1891(f)(2)(A)(i) (42 U.S.C. §§ 1395cc(b)(2)(B), 1395bbb(f)(2)(A)(i)); 42 C.F.R. §§ 488.845, 489.53(a)(3); *Nightingale Home Healthcare, Inc.*, DAB No. 2784 at 2 (2017).  Uncorrected deficiencies, even at the standard level, may justify sanctions, although the provider usually has 60 days in which to correct a standard-level deficiency.  42 C.F.R. § 488.28.
The hearing before an ALJ is a *de novo* proceeding.  *CarePlex of Silver Spring*, DAB No. 1683 at 9 (1999) (holding that ALJs hold *de novo* hearings based on issues permitted under the regulations and ALJ review is not a quasi-appellate review); *see also Claiborne-Hughes Health Ctr. v. Sebelius*, 609 F.3d 839, 843 (6th Cir. 2010) (The Departmental Appeals Board (DAB) “reviewed the finding under the *de novo* standard that the ALJ would have applied”).  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 this occurs, the HHA must, in order to prevail, prove substantial compliance by a preponderance of the evidence.  *See Hillman Rehab. Ctr.*, DAB No. 1611 at 8 (1997), *aff’d*, *Hillman Rehab. Ctr. v. U.S. Dep’t of Health & Human Servs.*, No. 98-3789 (GEB) (D.N.J. May 13, 1999); *see also* *Batavia Nursing & Convalescent Inn*, DAB No. 1911 (2004), *aff’d*, *Batavia**Nursing & Convalescent Ctr. v. Thompson*, 143 F. App’x 664 (2005); *Batavia Nursing & Convalescent Ctr.*, DAB No. 1904 (2004), *aff’d*,*Batavia*
**Page 6**
*Nursing and Convalescent Ctr. v. Thompson*, 129 F. App’x 181 (2005); *Emerald Oaks*, DAB No. 1800 (2001); *Cross Creek Health Care Ctr.*, DAB No. 1665 (1998).
**B. Findings of Fact, Conclusions of Law, and Analysis**
***1. Petitioner did not comply with all Medicare conditions of participation.7***
***a. Petitioner did not comply with the conditions of participation at 42 C.F.R. §§ 484.30 and 484.55.***
Petitioner has not challenged CMS’s determination that the services it provided to patients did not comply with 42 C.F.R. §§ 484.30 and 484.55.8
  CMS premised that determination on multiple findings from the July 22 and October 28, 2016 surveys, none of which Petitioner disputes.
**Condition of Participation:  42 C.F.R. § 484.30:**  HHAs are required to furnish skilled nursing services by or under the supervision of a registered nurse (RN) and in accordance with each patient’s plan of care.  42 C.F.R. § 484.30.  As relevant here, the RN makes the initial evaluation visit, regularly reevaluates the patient’s nursing needs, initiates the patient’s plan of care and necessary revisions, prepares clinical and progress notes, and informs the patient’s physician of changes in the patient’s condition or needs.  42 C.F.R. § 484.30(a).  If an HHA provides care through a licensed practical nurse (LPN), as Petitioner did, the LPN must, among other things, assist the physician and RN to perform specialized procedures.  42 C.F.R. § 484.30(b).
**Page 7**
**Condition of Participation:  42 C.F.R. § 484.55.**  HHAs are also required to conduct a comprehensive assessment of each patient “that accurately reflects the patient’s current health status and includes information that may be used to demonstrate the patient’s progress toward achievement of desired outcomes.”  42 C.F.R. § 484.55.  An RN must complete “an initial assessment visit to determine the immediate care and support needs of the patient” within 48 hours of either the referral or the patient’s return home, or on the physician-ordered start of care date.  42 C.F.R. § 484.55(a)(1).  An RN also must complete the comprehensive assessment within five days of the start of care.  42 C.F.R. § 484.55(b).  The comprehensive assessment must be updated “as frequently as the patient’s condition warrants,” including updating within “48 hours of the patient’s return to the home from a hospital admission of 24 hours or more for any reason other than diagnostic tests . . . .”  42 C.F.R. § 484.55(d)(2).
**Petitioner’s policies.**  Petitioner had several policies relevant to the discussion of its noncompliance with 42 C.F.R. §§ 484.30 and 484.55.  For example, Petitioner’s skilled nursing services policy largely tracks the language of 42 C.F.R. § 484.30.  CMS Ex. 6.  Similar to the regulation, that policy charges RNs with making initial evaluation visits, reevaluating patient nursing needs regularly, initiating the care plan and necessary revisions, preparing clinical and progress notes, and informing the physician of changes in a patient’s condition and needs.  *Id.* at 1.  That policy also charges LPNs with assisting the physician and RN to perform specialized procedures.  *Id.* at 2.
A policy titled “Vital Signs Protocols” described:  normal expected body temperatures, when measured in different ways and under different circumstances; normal heart rate, based on patient gender and other factors; normal resting respiration rate; normal blood pressure; and normal blood oxygen saturation levels.  CMS Ex. 17 at 1-4.  Where a physician ordered “standard vital sign protocol,” Petitioner’s staff was to call the physician if a patient exhibited a temperature above 100.4°F, a heart rate above 100 beats per minute (bpm) or below 60 bpm, respirations greater than 20 per minute or less than 12 per minute, systolic blood pressure above 130 mmHg or below 100 mmHg, or diastolic blood pressure above 90 mmHg or below 70 mmHg.  CMS Ex. 17 at 3.  Petitioner’s vital signs protocol stated that for “patients that are seen frequently, . . . [v]ital signs may be reduced to 1 time per week.”  CMS Ex. 17 at 4.
Petitioner also had a policy entitled “Home Health Aide:  Assignment.”  CMS Ex. 19.  An RN was to assign a home health aide to a particular patient and prepare written instructions for patient care.  *Id.* at 1.  The policy lists some examples of care that aides may provide.  *Id*.  Importantly, the first procedure states that an RN “shall make a home visit to assess the patient’s needs prior to initiation of home health aide services.”  *Id*.  In addition, the RN was to “explain the duties of the home health aide . . . .”  *Id*.
**July 22, 2016 survey findings.**  Patient 1 required home health services for colostomy complications.  CMS Ex. 29 at 1.  Additionally, she was diagnosed with type 2 diabetes,
**Page 8**
major depressive disorder, dementia without behavioral disturbance, and generalized anxiety disorder.  *Id*. Her prognosis was “[g]uarded,” and she was described as “likely to remain in fragile health and have ongoing high risk(s) of serious complications and death.”  *Id*.  Among other things, her care plan called for twice-weekly nursing visits, during which the nurse was to take vital signs.  *Id*.  The nurse was to notify Patient 1’s physician if her vitals fell outside the thresholds established in Petitioner’s vital sign protocols.  *Id*.; *see* CMS Ex. 17 at 3.  On three separate visits spanning more than a week, from April 21 through 29, 2016, the RN did not measure Patient 1’s vital signs.  CMS Ex. 30 at 1, 3, 4.
Patient 2’s file did not include a record of a doctor’s referral for home health services.  CMS Ex. 25 at 86-87.  Her care plan called for a skilled nurse to fill her medication box once weekly and supervise home health aides every other week.  CMS Ex. 48 at 1.  Her care plan did not specify any other skilled nursing care.  During two skilled nursing visits, however, the nurse measured Patient 2’s vital signs and performed a variety of assessments not called for in the care plan.  CMS Ex. 51 at 1-3; CMS Ex. 53 at 1-3.
Patient 3 required home health services to care for a second-degree burn on her right fifth toe.  She was also diagnosed with cellulitis, heart failure, ischemic cardiomyopathy, polyneuropathy, and fibromyalgia.  CMS Ex. 66 at 1.9
  Similar to Patient 1, Patient 3’s prognosis was “[g]uarded,” and she was also described as “likely to remain in fragile health and have ongoing high risk(s) of serious complications and death.”  *Id.* at 2.  Her doctor referred her to home health care on April 6, 2016.  CMS Ex. 65.  Petitioner conducted the initial assessment five days later, on April 11, 2016.  CMS Ex. 67.  Her care plan directed the nurse to perform wound care for her burned toe, including cleansing with hibiclens, applying silverstat to wound bed, covering with a dry dressing, and securing the site, every other day.  CMS Ex. 66 at 1.  The care plan goal was for her burn to be “free of [signs and symptoms] of infection . . . .”  *Id*.  Among other things,
**Page 9**
Petitioner’s wound care protocol called for measuring the wound “on Mondays or the first visit of the week,” reporting “[a]ny deterioration (or improvement that necessitates a change [in] wound treatment) in wound status . . . to the physician immediately,” and documenting the wound care given.  CMS Ex. 5.  In her declaration, the surveyor states that “[w]ithout measuring or assessing [a] wound, the nurse could not check for signs of infection or healing as directed by the plan of care.”  CMS Ex. 2 ¶ 24.  On two visits, June 19 and 24, 2016, neither the LPN nor the RN documented performing wound care.  CMS Ex. 69 at 7-9.  I infer from this lack of documentation that the nurses did not provide wound care during these visits.  In addition, for 11 separate visits from June 11 through July 7, 2016, neither the RN (two visits) nor the LPN (nine visits) documented measurements of Patient 3’s wound, contrary to Petitioner’s policy.  CMS Ex. 69 at 1, 3, 4, 5, 7, 8, 17, 21, 24, 28, 31.  Progress notes for four of those visits state, “No Wound Records were Found,” even though the nurse documented that she provided wound care on those visits.  *Id.* at 21, 24, 28, 31.
Patient 5 required home health care following inpatient surgery to close a stage 3 pressure ulcer to her left hip.  CMS Ex. 71 at 11.  The patient’s pressure ulcer had become infected with methicillin-resistant staphylococcus aureus (MRSA).  *Id*. Patient 5’s medical history was also significant for quadriplegia, neurogenic bowel, and incontinence of bowel.  CMS Ex. 70 at 1.  Patient 5 had an “extensive surgical wound,” a Jackson‐Pratt (JP) drain (to drain fluid from the surgical site), and a peripherally inserted central catheter (PICC) line through which the patient was administered antibiotics.  CMS Ex. 71 at 11.  During the initial assessment on March 8, 2016, the RN did not measure the surgical wound or describe the location of the JP drain.  CMS Ex. 71 at 10-11.  Patient 5’s care plan directed the nurse to assess her for signs and symptoms of an infected wound, to change the surgical site dressing daily (or educate the caregiver to do so), and to change the PICC dressing every week and as needed.  CMS Ex. 70 at 1-2.  The patient’s care plan did not include any instructions to assess or provide care for the JP drain.  *Id*.10
  The RN took Resident 5’s vital signs on April 5, 2016, but no nurse documented vital signs again until April 16, 2016, a gap of more than one week.  CMS Ex. 72 at 18, 35.  This is so even though Petitioner provided nursing visits on five intervening dates, including April 12, 2016, which was seven days after April 5, 2016.  *See id.*at 21, 23, 26, 29, 32.  Progress notes also fail to document that Petitioner’s staff changed the PICC dressing at any time from the start of care until the PICC line was removed.  CMS Ex. 72 at 1-2, 4-5, 8-10.  During 12 visits from March 12 through April 16, 2016, neither the LPN (three visits) nor the RN (nine visits) measured Patient 5’s wound.  CMS Ex. 72 at 1, 4, 7, 9, 12, 15, 21, 23, 26, 29, 32, 35.  Progress notes for two of those visits state, “No Wound Records were Found,” even though the nurse documented
**Page 10**
that she provided wound care on those visits.  *Id.* at 32, 35.  During the visit on March 12, 2016, the nurse assessed the JP drain, despite no instruction to do so in the care plan.  CMS Ex. 72 at 1.
Patient 6 required care related to a principal diagnosis of periodic paralysis, with additional diagnoses of general muscle weakness, heart failure, Parkinson’s disease, and chronic kidney disease.  CMS Ex. 76 at 1.  His doctor referred him to home health care on May 18, 2016.  CMS Ex. 73 at 2.  Petitioner conducted the initial assessment nine days later, on May 27, 2016.  CMS Ex. 74.11
  Patient 6’s care plan called for a total of two visits from a skilled nurse.  CMS Ex. 76 at 1.  However, Petitioner’s records indicate that he received three skilled nurse visits, one each on May 27, June 1, and June 7, 2016.  CMS Exs. 74, 77, 78.
During the survey, the surveyor conducted a home visit observation of Patient 7.  CMS Ex. 25 at 58.  At that time, the surveyor observed a red area approximately two cm long and two cm wide on Patient 7’s right heel.  CMS Ex. 2 ¶ 28; CMS Ex. 25 at 58.  Patient 7 told the surveyor the red area was sore and had been sore and red for about two weeks.  *Id*.  He also told the surveyor that Petitioner had known about the red area and his pain for at least two weeks.  *Id*.  In her declaration, the surveyor describes the painful red area as “a change in patient 7’s status” but notes that Petitioner “took no steps to address the sore until [she] alerted them to it . . . on the morning of July 18, 2016.”  CMS Ex. 2 ¶ 28.  The agency contacted Patient 7’s physician that afternoon.  *Id*.  That same day, Patient 7’s physician ordered a gel heel pad to treat an “[u]nspecified injury of right foot . . . .”  CMS Ex. 79.
Patient 9 required home health care related to a colostomy, and his medical history included muscle weakness, late effects of poliomyelitis, type 2 diabetes, and hypertensive chronic kidney disease.  CMS Ex. 83 at 1.  His care plan called for Petitioner to inform his physician if he gained “more than 10 pounds in 30 days . . . .”  *Id*.  His initial assessment states that he is “[o]verweight” but does not include a precise weight.  CMS Ex. 84 at 2.  Notes from five later nursing visits also do not include Patient 5’s weight.  CMS Exs. 85, 86.  Notes from three of the visits suggest that Patient 5 had not gained weight.  CMS Ex. 86 at 1, 4, 9.  However, the absence of any weight measurements undermines the credibility of these notes.
Patient 11 required home health care related to an ileostomy, and she had a history of muscle weakness, atrial fibrillation, Alzheimer’s disease, obesity, hypertension, collapsed abdominal walls, and chronic pain.  CMS Ex. 87 at 1.  During a home visit observation,
**Page 11**
the surveyor noted that Patient 11’s “skin area surrounding the ileostomy area was . . . very red the entire circumference of the stoma area with 3 small red open areas observed on the bottom or inferior side of the stoma opening.”  CMS Ex. 25 at 58, 75.  A progress note dated June 24, 2016, documents bleeding around the ostomy stoma, which apparently occurred when the flange and colostomy bag were changed.  CMS Ex. 88.  The surveyor opined that Petitioner should have informed Patient 11’s physician of this change in status because the red area occurred in an area “particularly vulnerable to infection.”  CMS Ex. 2 ¶ 29.
**October 28, 2016 survey findings.**  Patient 12 required home health care to treat a stage 4 pressure ulcer in his sacral region.  CMS Ex. 99 at 1.  He was also diagnosed with diabetes with polyneuropathy, hypertension, cerebral palsy, COPD, and major depressive disorder.  *Id*.; *see also*CMS Ex. 100 at 2.  Patient 12 was described as “likely to remain in fragile health and have ongoing high risk(s) of serious complications and death.”  CMS Ex. 100 at 2.  On September 16, 2016, Patient 12 was admitted to a skilled nursing facility, which discharged him a week later.  CMS Ex. 97 at 14, 18-19.  Although Patient 12 returned home on September 23, 2016, Petitioner did not perform a resumption of care assessment for him until October 25, 2016.  CMS Ex. 100 at 1.  Moreover, the assessment Petitioner belatedly completed failed to document important information.  Petitioner did not document in the assessment Patient 5’s vital signs, wound measurements for his pressure ulcer, or any nursing assessment of his cardiovascular, musculoskeletal, nervous, endocrine, gastrointestinal, and urinary systems.  CMS Ex. 97 at 18; CMS Ex. 100 at 1-9.
Patient 13 required home health care related to her primary diagnosis of type 2 diabetes with neuropathy, hyperglycemia, and long-term use of insulin.  CMS Ex. 102 at 1.  Patient 13’s most recent care plan in effect prior to the survey expired on October 20, 2016.  *Id*.  The surveyor states in her declaration that Patient 13’s record included “nothing . . . indicating that her doctor gave verbal confirmation of her plan of care for October 21, 2016 to December 19, 2016.”  CMS Ex. 2 ¶ 38.  During an in-home observation that occurred after October 20, 2016, the surveyor observed Petitioner’s staff provide care to Patient 13, even though her care plan had expired.  CMS Ex. 97 at 11.  The RN assessed Patient 13’s vital signs, gave her a flu shot, set up her medication reminder box with a week’s worth of medications, and performed a finger stick to test her blood glucose level.  *Id.* at 11-12, 15-16, 19.
Patient 15 was referred for home health care on October 3, 2016.  CMS Ex. 104 at 1.  She was first visited by a home health aide on October 4, 2016, from 6:45 a.m. to 8:45 a.m.  CMS Ex. 105.  However, Petitioner’s RN did not make her initial assessment visit until 9:26 a.m. that same day, after the aide’s visit.  CMS Ex. 97 at 12-13, 30; CMS Ex. 2 ¶ 39.  The aide thus provided care before a nurse assessed Patient 15’s needs and provided the aide with instructions for proper care, contrary to Petitioner’s home health aide assignment policy.  CMS Ex. 19 at 1.
**Page 12**
CMS’s undisputed findings from the July and October surveys demonstrate multiple violations of 42 C.F.R. §§ 484.30 and 484.55, as well as Petitioner’s own policies.  Petitioner’s nurses, RNs and LPNs alike, did not follow the care plans for seven of its patients (Patient 1, Patient 2, Patient 3, Patient 5, Patient 6, Patient 9, and Patient 13) across the July and October surveys, either by failing to provide necessary care or by providing care not called for in the care plan.  The initial assessments of four patients (Patient 3, Patient 5, Patient 6, and Patient 15) were inadequate or conducted untimely.  Petitioner did not inform physicians timely (or at all) of a change of status for two patients (Patient 7 and Patient 11).  Notably, within hours of being notified of the change of status, Patient 7’s physician faxed an order to treat the condition that gave rise to the change of status.  CMS Ex. 79.  For two patients (Patient 12 and Patient 13), Petitioner did not maintain complete and accurate progress notes.  This occurred because Petitioner’s staff provided care to Patient 12 before completing a resumption of care assessment (which was significantly delayed) and allowed Patient 13’s care plan to expire without replacement.  CMS Ex. 2 ¶¶ 38-40; CMS Ex. 97 at 14, 18-20; CMS Ex. 100; CMS Ex. 102 at 1.  Finally, Petitioner did not effectively reevaluate the nursing needs of or fully and timely update the comprehensive assessments for two patients (Patient 3 and Patient 12).  At least three of the patients affected by these deficiencies (Patient 1, Patient 3, Patient 12) were in poor health and faced a high risk of serious complications and death.  CMS Ex. 29 at 1; CMS Ex. 66 at 2; CMS Ex. 100 at 2.
Petitioner’s deficiencies substantially limited its capacity to furnish adequate care to its patients and adversely affected patient health and safety.  Petitioner therefore did not comply with 42 C.F.R. §§ 484.30 and 484.55.
***b. Petitioner did not comply with the condition of participation at 42 C.F.R. § 484.10.***
**Condition of Participation:  42 C.F.R. § 484.10.**  An HHA patient has the right to be informed of his or her rights, and HHAs “must protect and promote the exercise of these rights.”  42 C.F.R. § 484.10.  An HHA patient also “has the right to exercise his or her rights as a patient of the HHA” and “the right to voice grievances regarding treatment or care that is (or fails to be) furnished . . . and must not be subjected to discrimination or reprisal for doing so.”  42 C.F.R. § 484.10(b)(1), (4).
**Petitioner’s policies.**  Petitioner maintained a “Patient/Client Bill of Rights” that listed 11 rights that Petitioner’s patients had.  CMS Ex. 12.  Among other rights, Petitioner’s patients had “the right to be treated with dignity and be free from physical, verbal, and psychological abuse.”  *Id*.  Also pertinent here, Petitioner’s patients had “the right to voice grievances regarding treatment or care that is (or fails to be) furnished,” and, should they exercise this right, Petitioner stated that patients would “not be subjected to discrimination or reprisal.”  *Id*.
**Page 13**
Petitioner’s policy pertaining to patient complaints and grievances similarly provided that “[p]atients may voice concerns and grievances regarding any aspect of care/service without fear of coercion, discrimination, reprisal or unreasonable interruption in service.”  CMS Ex. 9 at 1.  Petitioner’s policy authorized any staff member to receive a complaint or grievance and, having done so, the staff member was obligated under the policy to report the complaint to the administrator or her designee.  *Id*.  The administrator was tasked with investigating complaints and grievances, taking evidence from “all interested persons,” maintaining records related to grievances, and issuing a written decision about the grievance within 30 days of filing.  *Id.* at 1-2.  The administrator or her designee was also responsible for imposing discipline based on her findings.  Such discipline could range from “counsel[ing] appropriate staff as needed to prevent occurrence” to “employee termination if indicated depending upon each complaint and the findings.”  *Id.* at 3.
Petitioner’s policy for reporting abuse, neglect, or exploitation similarly assigned to Petitioner’s administrator responsibility for addressing incidents of suspected abuse.  CMS Ex. 11.  Staff were to report any suspected abuse to a supervisor, who would report it to the director of nursing, who in turn reported the incident to the administrator.  *Id.* at 1, 3.  The administrator would then investigate the report to determine whether staff responded to the incident appropriately.  *Id.* at 1.  The administrator was responsible for presenting to Petitioner’s governing body her findings and follow-up actions and any new or changed policies or procedures that she thought might “reduce or eliminate future re occurrences [sic].”  *Id*.  The administrator was also responsible for reporting to the appropriate licensing board any licensed staff found to have committed abuse.  *Id*.  The abuse reporting policy also provided that Petitioner “may not retaliate against a person for filing a complaint, presenting a grievance, or providing, in good faith, information.”  *Id.* at 2.
**Patient 2.**  At the time of the July survey, Patient 2 was a 56-year-old woman who required home health care related to her primary diagnosis of multiple sclerosis.  CMS Ex. 48 at 1.  She lived at home with her husband, who was her primary caregiver.  CMS Ex. 64 at 1; P. Ex. 3 at 3.  In addition to multiple sclerosis, Patient 2 was diagnosed with trigeminal neuralgia, chronic fatigue, and obstructive sleep apnea.  CMS Ex. 48 at 1.  Her prognosis was described as “[f]air,” but her rehabilitation potential indicated that she was “likely to remain in fragile health and have ongoing high risk(s) of serious complications and death.”  *Id*.  The goal of her care plan was for Petitioner to effectively meet her needs related to activities of daily living.  *Id*.  To meet those needs, Petitioner created a care plan that called for one visit per week from a skilled nurse and six visits per week for eight hours per day from a home health aide.  *Id*.  Petitioner began providing care to Patient 2 on June 8, 2016.  *Id*.
**Page 14**
Not long after Petitioner began caring for Patient 2, Patient 2’s husband began reporting complaints to Petitioner about the care she was receiving.  On June 14, 2016, Patient 2’s husband made his first complaint.  CMS Ex. 55.  On that occasion, he complained that one of Petitioner’s aides engaged in unsanitary behavior while providing care to Patient 2; behavior that Patient 2’s husband had captured in a video recording.  *Id.* at 2.12
  On June 15, 2016, Patient 2’s husband complained that one of Petitioner’s nurses stated to Patient 2 she could only stay for half an hour and then allegedly filled Patient 2’s medicine box incorrectly.  CMS Ex. 56.  The nurse denied the allegations, and Petitioner’s records indicated that the nurse had stayed at Patient 2’s residence for 1.75 hours.  *Id*.  On June 21, 2016, Patient 2’s husband complained that another of Petitioner’s aides had “picked her nose” while providing care to Patient 2.  CMS Ex. 59.13
  The aide denied the incident, but Petitioner gave her a verbal warning.  *Id*.  On June 22, 2016, Patient 2’s husband reported a fourth complaint, asserting that another of Petitioner’s nurses “‘flipped’ med[ication]s in the wrong compartments of [Patient 2’s] med[ication] box.”  CMS Ex. 58.  The nurse denied that the compartments of Patient 2’s medication box could have been interchanged.  CMS Ex. 57.  In a nursing communication dated June 22, 2016, Petitioner’s administrator noted, “It appears [Patient 2’s husband] may be manipulating situations at the home.”  *Id*.  Finally, on the morning of June 24, 2016, Patient 2 called Petitioner “very irate and somewhat unintelligible”; her husband got on the phone and alleged that one of Petitioner’s aides “had walked out and she had hit his garbage cans” and “became very disrespectful . . . .”  P. Ex. 7 at 2.
Within hours of Patient 2’s call, Petitioner discharged Patient 2 from its care.  CMS Exs. 60-62; *see also*P. Ex. 7 at 2.  The stated basis for the termination was because Patient 2’s husband was “threatening and extorting the agency and staff.”  CMS Ex. 60.  Petitioner’s administrator called Patient 2 and explained that she “did not feel [Petitioner was] the right agency for [Patient 2]” and that her husband’s “use of threats and extortion could not go on.”  P. Ex. 7 at 2.
On the evening of the same day that Petitioner discharged Patient 2, Petitioner’s administrator began calling Patient 2 and her husband repeatedly, leaving at least 11
**Page 15**
voicemail messages for one or the other within a period of an hour until she was told by police to stop calling them.  CMS Ex. 2 ¶ 11; CMS Exs. 37-47, 64.  Petitioner admits that its administrator contacted Patient 2’s husband after having “a few glasses of wine” and that her response was “somewhat unprofessional.”  P. Br. at 13; *see also* P. Br. at 11 (“Associated’s owner [and administrator] admits that, after [Patient 2] was discharged from Associated, she made a number of unprofessional statements to [Patient 2’s] husband”).  This is consistent with the voicemails submitted as exhibits by CMS, in which the administrator slurs her words and at times sounds as if she is struggling to organize her thoughts.  CMS Exs. 37-47.  It is also consistent with a police report regarding the incident, in which the officer describes her messages as “unprofessional and borderline harassment.”  CMS Ex. 64 at 1.  Petitioner does not dispute the authenticity of any of these messages.  *See*P. Br. at 13.  When asked in a separate proceeding whether she had made “inappropriate comments” when calling Patient 2’s husband, Petitioner’s administrator admitted under oath that she “could have” made such comments and that she “had been drinking.”  P. Ex. 3 at 34.  According to sworn testimony from Patient 2’s husband in the same proceeding, the administrator mostly left voicemails after calling his phone number, which was separate from Patient 2’s phone number.  P. Ex. 3 at 18.  Based on my review of the messages, I find that the nine messages contained in CMS Exs. 37 and 40-47 were left for Patient 2’s husband, while the two messages contained in CMS Exs. 38 and 39 were left for Patient 2.
In one voicemail to Patient 2’s husband, the administrator states that she is going to call Adult Protective Services and “Medicaid Services” to report on the living conditions in Patient 2’s home to “be able to cut you off because your wife should be in a institution [sic] and not in your care.”  CMS Ex. 37 at 0:15-1:04.  In another voicemail, this one left for Patient 2, the administrator also states that she is going to contact Adult Protective Services because she feels that Patient 2’s husband is manipulating Patient 2 and that Patient 2 was in danger due to the configuration of her “home situation.”  CMS Ex. 38 at 0:40-1:05.  In the rest of her messages to Patient 2’s husband, the administrator repeatedly states that she is going to contact Adult Protective Services and Medicaid about the conditions in his home and his treatment of his wife.  CMS Exs. 40-47.  Her tone varies from smug (at times gleefully so) and condescending to aggressive to borderline hysterical.  In one voicemail, she tells Patient 2’s husband he’s “so screwed,” uses an expletive, and states that she is “going to take [him] down,” that she’s “got it over [him],” and that he “better call” her.  CMS Ex. 40 at 0:33-0:35, 0:58-1:00, 1:10-1:13, 1:38-1:41, 1:44-1:46.  In another, she tells him to “quit being a baby.”  CMS Ex. 45 at 0:03-0:04.  In a third, she says, “You wanna talk about anything?  You better frickin’ call me.”  CMS Ex. 46 at 1:22-1:26.  In a fourth, she says sarcastically, “Thank you,” mockingly enunciating the names of Patient 2 and her husband before cackling loudly and saying, again sarcastically, “I love you people.”  CMS Ex. 47 at 0:54-1:07.
During the survey, the surveyor called Adult Protective Services “and was told that [Petitioner’s administrator] never made a complaint regarding [P]atient 2’s living
**Page 16**
situation.”  CMS Ex. 2 ¶ 13.  The surveyor also interviewed Patient 2, describing her as “tearful and visibly upset when discussing how she was treated by [Petitioner] for making her complaints.”  *Id*.  The surveyor goes on to state in her declaration that Patient 2 “cried while discussing [the administrator’s] abuse and said she found it difficult to trust other HHAs to respect her rights.”  *Id.* at ¶ 16.  In addition, Patient 2 told the surveyor “that her pain and the severity of her headaches had increased because of the stress brought on by [the administrator’s] treatment.”  *Id*.  Petitioner does not dispute this evidence or otherwise attempt to rebut it.
As just described, following complaints by Patient 2’s husband, Petitioner’s administrator herself made statements to Patient 2 and her husband that could be viewed as abusive.  Yet, nothing in the record demonstrates that, prior to the survey, Petitioner’s administrator removed herself as the person responsible for addressing patient complaints and allegations of patient abuse.  To the contrary, the surveyor’s declaration indicates that the administrator continued to exercise those responsibilities until the survey.  CMS Ex. 2 ¶ 17.  Even after re-assigning responsibility for addressing patient complaints to the assistant administrator, Petitioner had not ensured, by the conclusion of the July survey that its entire staff knew to report complaints and abuse allegations to the assistant administrator rather than the administrator.  *Id*.  Thus, I find it more likely than not that the administrator continued to serve as the main person responsible for handling patient complaints and allegations of patient abuse through the date of the survey, even after her highly inappropriate, indeed abusive,14
 behavior towards Patient 2 and Patient 2’s husband.  I further find that even after the survey, Petitioner had not ensured that its full staff was aware that they should report complaints and grievances to the assistant administrator, rather than the administrator.
Per Petitioner’s policies, Petitioner’s administrator had significant responsibility for protecting and promoting Petitioner’s patients’ rights, including their right to file complaints without reprisal and their right to be free of abuse.  CMS Ex. 9 at 1-3, CMS Ex. 11 at 1.  Yet, Petitioner’s administrator violated Patient 2’s rights by repeatedly calling and leaving abusive messages for Patient 2 and her husband.  She did so within hours of Patient 2’s discharge.  Based largely on the questionable timing of the administrator’s abusive behavior, I find it more likely than not that the administrator’s
**Page 17**
phone calls and messages were intended, at least in part, as responses to the complaints registered by Patient 2 and her husband.  The administrator thus violated Patient 2’s right to voice grievances regarding the treatment Petitioner provided without being subject to reprisal.  42 C.F.R. § 484.10(b)(4).  More fundamentally, the administrator’s messages violated Patient 2’s rights to be treated with dignity and to be free from verbal and psychological abuse and contravened Petitioner’s duty to protect Patient 2’s rights.  42 C.F.R. § 484.10; CMS Exs. 12, 50.
The evidence also establishes that Petitioner’s violations of the regulations adversely affected Patient 2’s health.  The surveyor’s observations show that Patient 2 was quite upset over the administrator’s harassing phone messages, suffering worsened headaches due to the stress.  CMS Ex. 2 ¶¶ 13, 16.  Further, Petitioner’s violations of its policies and the regulation also had the potential to adversely affect the health of Petitioner’s other patients.  This risk was present even though Petitioner discharged Patient 2, because Petitioner’s administrator remained responsible for addressing patient complaints and allegations of abuse, despite exhibiting the potential to act abusively towards patients.
Notwithstanding the foregoing, Petitioner argues, in essence, that its administrator’s abusive behavior did not amount to condition-level noncompliance because, although unwise, it was justified by Patient 2’s husband’s own misbehavior.  P. Br. at 11.  Petitioner describes in detail the sequence of events that began with Patient 2’s husband’s first complaint, involving the video recording of an aide acting in an unsanitary way, and ended with the administrator’s alcohol-infused messages.  P. Br. at 3-14.  Petitioner alleges that Patient 2’s husband was very hard to please, as evidenced by the multiple complaints he made, some of which Petitioner attacks as meritless or even fabricated.  *Id*. at 3-11.  Petitioner claims, nonetheless, that it responded to each of his complaints appropriately but that he was not satisfied and continuously threatened to ruin Petitioner and Petitioner’s administrator by publishing the recording of Petitioner’s aide on regular and social media.  *Id.* at 3-4, 6, 10-12.15
  According to Petitioner, Patient 2’s husband also was abusive towards Petitioner’s staff, demanding they perform work outside their scope of care and yelling at them repeatedly when they did not satisfy his whims.  *Id.* at 8-11.
Even accepting, for purposes of this decision, the truth of Petitioner’s allegations about how difficult Patient 2’s husband was, its administrator’s abusive behavior when responding to that difficulty was a serious violation of Petitioner’s obligations under federal law.  Although, by its own account, Petitioner was placed in a very difficult position trying to satisfy a hard-to-please patient and her husband, that does not excuse Petitioner from respecting and promoting Patient 2’s rights to file grievances without
**Page 18**
retaliation, to be treated with dignity, and to be free from abuse.  Had Petitioner truly been motivated to discharge Patient 2 entirely due to its difficulty in dealing with her husband and out of concern for its inability to satisfy her care needs, it could have discharged her and left it at that.  Only hours after discharging her, though, Petitioner’s administrator began leaving messages for Patient 2 and her husband that served no other apparent purpose than to intimidate and harass them and that directly caused harm to Patient 2.  Ultimately, then, Petitioner’s argument does not convince me to reject the conclusions that Petitioner violated its duties under 42 C.F.R. § 484.10 and that its violation of those duties adversely affected patient health.  Consequently, I conclude that Petitioner did not comply with the condition of participation at 42 C.F.R. § 484.10.
***2. CMS’s immediate jeopardy determination is not clearly erroneous**.*
Immediate jeopardy is “a situation in which the [HHA’s] noncompliance with one or more requirements of participation has caused, or is likely to cause serious injury, harm, impairment or death to a patient(s).”  42 C.F.R. § 488.805.  The regulation does not require that a patient *actually*be harmed.  *Nightingale*, DAB No. 2784 at 18.  I must uphold CMS’s determination as to the level of a facility’s substantial noncompliance (which includes an immediate jeopardy finding) unless it is “clearly erroneous.”  42 C.F.R. § 498.60(c)(2); *Nightingale*, DAB No. 2784 at 18.  The “clearly erroneous” standard imposes on facilities a heavy burden to overcome a finding of immediate jeopardy.  Appellate panels of the DAB have sustained determinations of immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.”  *See, e.g.*,*Barbourville Nursing Home*, DAB No. 1962 at 11 (2005) (citing*Florence Park Care Ctr.*, DAB No. 1931 at 27-28 (2004)),16
 *aff’d*,*Barbourville Nursing Home v. U.S. Dep’t of Health & Human Servs.*, 174 F. App’x 932 (6th Cir. 2006); *see also, e.g.*, *Easley v. Cromartie*, 532 U.S. 234, 242 (2001) (“In applying [the clearly erroneous] standard, . . . a reviewing court must ask whether, ‘on the entire evidence,’ it is ‘left with the definite and firm conviction that a mistake has been committed.’”).
On this record, I am unable to say that I have a definite and firm conviction that the declaration of immediate jeopardy was a mistake.  Not only did Petitioner’s administrator, the person responsible for handling patient complaints and abuse allegations, herself act abusively towards a patient, she remained in charge of handling patient complaints and abuse allegations even after her highly inappropriate behavior.
**Page 19**
All of Petitioner’s patients, whether current or future, were at risk of being subjected to similar behavior while this state of affairs persisted.
Petitioner argues that its administrator’s actions were “not an issue that rose to the level of an immediate jeopardy and only occurred after [Patient 2’s] husband had repeatedly called and threatened to publish the videos in order to destroy the [administrator] and her agency.”  P. Br. at 11.  Petitioner expands on this argument, averring “[t]his was an isolated incident arising out of the unreasonable conduct of [Patient 2’s] husband and had been finally resolved before the survey” and claiming “[t]here is no evidence that these issues impacted any other patients.”  P. Br. at 15.
Petitioner’s argument suffers from three fatal flaws.  First, as stated, I do not review the record to determine whether I think the facts rise to the level of immediate jeopardy.  Instead, I must determine whether the facts are such that I am firmly convinced that CMS made a mistake in declaring immediate jeopardy.  Under that heightened standard, Petitioner’s attempt to shift blame for its serious noncompliance with respect to Patient 2’s husband does not support a finding in Petitioner’s favor.  Second, even if Patient 2’s husband was a very difficult person to deal with, Petitioner still was obligated to take the high road and respect and promote Patient 2’s rights.  Finally, even accepting that the incident was isolated and that no evidence shows other patients were impacted directly, so long as Petitioner’s administrator remained in charge of handling patient grievances and abuse allegations, there was a risk that the harm Patient 2 suffered due to Petitioner’s noncompliance could befall other patients.
For these reasons, I conclude that CMS did not clearly err in determining that Petitioner’s noncompliance with 42 C.F.R. § 484.10 posed immediate jeopardy to patient health and safety.
**Page 20**
***3. The CMPs imposed are reasonable in amount and duration.***17
**CMP Regulations.**  The regulations regarding imposition of CMPs on home health agencies allow for the imposition of CMPs in three ranges:  upper, middle, and lower.  42 C.F.R. § 488.845(b)(3), (4), (5).  The upper range, $8,500 to $10,000 per day, is for condition-level deficiencies that constitute immediate jeopardy.  42 C.F.R. § 488.845(b)(3).  An $8,500 per day CMP is meant for an isolated incident of immediate jeopardy noncompliance.  42 C.F.R. § 488.845(b)(3)(i).  An upper-range CMP continues until compliance can be determined based on a revisit survey.  *Id*.  The middle range, $1,500 to $8,500, is for repeat or condition-level deficiencies that directly relate to poor quality patient care outcomes.  42 C.F.R. § 488.845(b)(4).
There are additional regulatory factors that may be considered in determining the appropriate amount of a civil money penalty.  42 C.F.R. § 488.845(b)(1) (cross‐referencing 42 C.F.R. § 488.815).  These 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).  The size and resources of an agency are also relevant considerations.  42 C.F.R. § 488.815(b)(1)(ii).
**Amount.**  CMS decided to impose per-day CMPs in this case, and I have found that the declaration of immediate jeopardy is not clearly erroneous.  For the period of Petitioner’s immediate jeopardy level noncompliance (July 22 through August 18, 2016), CMS imposed a CMP of $8,500.00 per day.  CMS Ex. 1 at 1, 8.  This amount is the minimum amount authorized for such noncompliance.  42 C.F.R. § 488.845(b)(3).  Therefore, the amount of this CMP is reasonable as a matter of law.
**Page 21**
Petitioner’s noncompliance with 42 C.F.R. §§ 484.30 and 484.55, discussed in detail above, plainly relate directly to poor quality patient care outcomes.  CMS therefore had a basis to impose a CMP in the middle range for Petitioner’s noncompliance with these conditions of participation.  42 C.F.R. § 488.845(b)(4).
Initially, from August 19 through October 27, 2016, CMS imposed a CMP of $2,000 per day, which is near the bottom of the middle range.  CMS Ex. 1 at 8-9, 14.  Following the October survey, CMS increased the CMP to $6,500 per day, which is in the upper half of the middle range, effective from October 28 through December 19, 2016.  CMS Ex. 1 at 15, 20.  Petitioner does not specifically challenge the reasonableness of these CMPs or argue that any particular regulatory factor supports a reduction of the CMP amounts.  For that reason alone, I could conclude the CMPs are reasonable in amount and duration.  *See Coquina Ctr.*, DAB No. 1860 at 32 (2002).  However, Petitioner does state generally its belief that the CMPs imposed are “unfounded and unreasonably excessive.”  P. Br. at 3.
On this record, the only factor that conceivably could warrant a reduction in the CMP is Petitioner’s size and resources.  However, Petitioner submitted no evidence to demonstrate an inability to pay the CMP.  At most, Petitioner’s evidence shows that it is a relatively small agency.  *See, e.g.*, P. Ex. 7 at 1 (indicating Petitioner “only ha[d] 12 aides”).  It would be speculative to infer that Petitioner lacks financial resources based solely on the number of aides it employed.
In any event, size and resources are only two factors among many to consider in addressing whether a CMP is reasonable.  Even assuming that Petitioner’s size and resources weigh in favor of a smaller CMP, other pertinent factors weigh against reducing the CMP.  Petitioner’s noncompliance with 42 C.F.R. §§ 484.30 and 484.55 was serious, adversely affecting many of Petitioner’s patients, and reflected a systemic failure to provide quality care to Petitioner’s patients.  The seriousness of the noncompliance alone warrants the $2,000 per day CMP, which, as noted, is near the bottom of the middle range of permissible CMPs.  42 C.F.R. § 488.845(b)(4).  One might suppose that even such a modest CMP (given the available CMP range) would prompt a small agency like Petitioner to move expeditiously to return to compliance.  Yet even after the state agency and CMS notified Petitioner that it was noncompliant and imposed the $2,000 per day CMP that would continue until it returned to compliance, Petitioner remained noncompliant with 42 C.F.R. §§ 484.30 and 484.55.  Petitioner’s sustained noncompliance continued to affect adversely the quality of care provided to Petitioner’s patients for many months.  Clearly, the already-imposed $2,000 per day CMP was inadequate to induce Petitioner to return to compliance by the time the surveyor returned in October 2016.  Under these circumstances, I cannot say that an increase in the CMP from $2,000 per day to $6,500 per day to underscore the need for Petitioner to return to compliance with all conditions of participation was unreasonable.  To the contrary, I find that the totality of the relevant factors support the reasonableness of the $6,500 per day CMP.  In particular, the seriousness and lengthy duration of the noncompliance and the
**Page 22**
fact that Petitioner demonstrated repeated instances of noncompliance, even after the initial survey put Petitioner on notice of its noncompliance, continued to affect adversely the quality of care Petitioner provided to its patients.  Therefore, I conclude that the $2,000 per day CMP, effective August 19 through October 27, 2016, and the $6,500 per day CMP, effective October 28 through December 19, 2016, are reasonable in amount.
**Duration**.  Petitioner does not challenge the duration of the CMPs or argue that it abated immediate jeopardy before August 19, 2016, or that it returned to compliance with all conditions of participation earlier than December 20, 2016.  Petitioner also has not demonstrated that CMS’s determination regarding the duration of the period of immediate jeopardy is clearly erroneous.  Therefore, I also conclude that the CMPs imposed are reasonable in duration.
V. Conclusion
For all the reasons discussed above, I find that Petitioner did not comply with Medicare conditions of participation from July 22 through December 19, 2016.  CMS’s finding of immediate jeopardy from July 22 through August 18, 2016, is not clearly erroneous.  The imposed CMPs, $8,500 per day effective July 22 through August 18, 2016; $2,000 per day effective August 19 through October 27, 2016; and $6,500 per day effective October 28 through December 19, 2016, a total CMP of $722,500, are reasonable.  Therefore, I conclude that CMS had a basis to impose those CMPs on Petitioner.


          /s/
        Leslie A. Weyn

                      Administrative Law Judge
      1. The January 27, 2017 survey revealed some additional standard-level deficiencies, CMS Ex. 1 at 19; CMS Ex. 98 at 1-20, but these deficiencies are not at issue in this case. back to note 1
                      2. In a final rule published January 13, 2018, CMS substantially revised and reorganized the conditions of participation for home health agencies codified in 42 C.F.R. pt. 484. 82 Fed. Reg. 4504, 4504, 4578-91 (Jan. 13, 2017) (initial revision and reorganization, effective July 13, 2017); 82 Fed. Reg. 31,729 (July 10, 2017) (delaying the effective date of revisions to the part 484 regulations until January 13, 2018, with conforming amendments). I cite to the codification of the regulations that was in effect during the period July through December 2016, when the findings of condition-level noncompliance were issued. back to note 2
                      3. CMS also initially determined to terminate Petitioner’s Medicare provider agreement, but it subsequently delayed and ultimately rescinded the termination action. CMS Ex. 1 at 2, 7, 8, 15, 19. back to note 3
                      4. Although Petitioner initially requested a hearing through counsel, Petitioner’s counsel ultimately withdrew from representing it. Dkt. Entry #3. back to note 4
                      5. Notably, Petitioner listed ten witnesses on its witness list but only submitted written statements from three of them (P. Exs. 5, 6, 9). None of those statements complies with my instructions for filing written direct testimony from witnesses, as they are neither affidavits made under oath nor written declarations that the witnesses signed under penalty of perjury. See Pre-hearing Order ¶ 8. back to note 5
                      6. The current version of the Social Security Act can be found at: https://www.ssa.gov/OP_Home/ssact/ssact-toc.htm. Each section of the Act on that website contains a reference to the corresponding United States Code chapter and section. In addition, a cross-reference table for the Act and the United States Code can be found at 42 U.S.C.A. Ch. 7, Disp. Table. back to note 6
                      7. My conclusions of law appear as headings in bold italic type. My findings of fact appear in the supporting text. back to note 7
                      8. Petitioner states generally in its brief that it has been in compliance with Medicare conditions of participation since 1993 and that it challenges the “findings of condition level noncompliance at the July 22, 2016 and October 28, 2016 surveys.” P. Br. at 1, 3. However, beyond these general statements, Petitioner submitted neither evidence nor argument to dispute or rebut CMS’s evidence of its condition-level noncompliance with 42 C.F.R. §§ 484.30 and 484.55. I warned the parties that their “pre-hearing brief[s] must contain any argument that [they] intend[] to make.” Pre-hearing Order ¶ 4. However, Petitioner’s specific arguments address only the alleged noncompliance with 42 C.F.R. § 488.10 that CMS found posed immediate jeopardy to patient health and safety. See generally P. Br. Similarly, Petitioner’s exhibits relate only to the alleged immediate jeopardy level-noncompliance. back to note 8
                      9. CMS, as did the surveyor, charged Petitioner also with a deficiency for failing to check Patient 3’s vital signs during multiple visits. CMS Br. at 11; CMS Ex. 25 at 44-45; CMS Ex. 69 at 5, 17, 31. However, Patient 3’s care plan instructs that the skilled nurse should “[u]se agency [p]rotocol” for measuring vitals. CMS Ex. 66 at 1. Petitioner’s vital signs protocol permitted staff to take vital signs once weekly for patients seen frequently. CMS Ex. 17 at 4. Progress notes indicate that the nurse followed Petitioner’s protocol, measuring Patient 3’s vitals on June 13, June 24, June 27, and July 5, 2016. CMS Ex. 69 at 3, 8, 18, 28. These are all dates within one week of the visits during which Petitioner did not measure Patient 3’s vitals. CMS Ex. 69 at 1 (June 11), 4 (June 15), 5 (June 17), 7 (June 19), 17 (June 25), 21 (June 29), 24 (July 1), 31 (July 7). I find it more likely than not that the documentation gap from June 13 to June 24 occurred because Patient 3 was hospitalized from on or about June 19, 2016, to on or about June 22, 2016, interrupting her in home care. See CMS Exs. 68 at 1, 3; 69 at 7-9. back to note 9
                      10. This may be explained by a note from the initial visit that the RN “educated [Patient 5’s mother] on JP care and how to empty contents [every day] and to record amount each time it is emptied.” CMS Ex. 71 at 11. back to note 10
                      11. Patient 6’s records include notes from what appear to be two separate initial assessments, one dated May 27, 2016, the other June 1, 2016. CMS Exs. 74, 75. Whichever date is used, it is clear that Petitioner did not conduct an initial assessment of Patient 6 within 48 hours of his referral to home health care. See 42 C.F.R. § 484.55(a)(1) back to note 11
                      12. CMS submitted as exhibits three video recordings depicting two different aides. CMS Exs. 34-36. Petitioner disputes that CMS Ex. 34 depicts one of its aides, but it does not dispute that CMS Exs. 35 and 36 depict one of its aides. P. Br. at 4-5. The resolution of the videos is not high, but the images in one clip appear to show a person putting her finger in her nose and then into her mouth, while the other clip appears to show a person fiddling with the waistband of her pants. CMS Exs. 35, 36. back to note 12
                      13. Despite the alleged inappropriate behavior, Patient 2’s husband indicated that he and Patient 2 still wanted the aide to care for Patient 2 “because she gave [Patient 2] ‘the best bath[ ]she had ever had.’” CMS Ex. 59. back to note 13
                      14. Although not directly applicable to home health agencies, regulations governing Medicare participation by skilled nursing facilities (SNFs) define abuse in a way that is instructive when compared to Petitioner’s administrator’s actions. Among other things, the SNF regulations state that “[a]buse is the willful infliction of . . . intimidation[] or punishment with resulting physical harm, pain or mental anguish.” 42 C.F.R. § 488.301. The voicemails Petitioner’s administrator left for Patient 2 and her husband leave a strong impression that she was attempting to intimidate or punish them, and, as a result, Patient 2 did suffer physical harm and pain (worsened headaches) as well as mental anguish. back to note 14
                      15. The record does not indicate whether he actually posted the video on social media, but he did show the video to police. CMS Ex. 64 at 1. It does not appear that the police took any action beyond informing Patient 2 and her husband of their “options.” Id. back to note 15
                      16. The Barbourville Nursing Home and Florence Park Care Center decisions address immediate jeopardy noncompliance by long-term care facilities, rather than HHAs. However, as the appellate panel observed in Nightingale, the definition of immediate jeopardy in the home health regulations parallels that in the long-term care regulations. Nightingale, DAB No. 2784 at 26. Therefore, the DAB’s analysis in long-term care cases is relevant in interpreting the home health regulations. back to note 16
                      17. I am permitted, “in the interests of judicial economy,” to review “only those deficiencies that have a material impact on the outcome of the dispute.” Claiborne Hughes Health Ctr. v. Sebelius, 609 F.3d 839, 847 (6th Cir. 2010). The deficiencies I have discussed above are adequate to support the enforcement remedies that CMS imposed on Petitioner. Thus, Petitioner’s compliance (or not) with 42 C.F.R. §§ 484.18, 484.36, and 484.48 do not “have a material impact on the outcome” of this case. Consequently, in the interest of judicial economy, I do not address Petitioner’s alleged noncompliance with these conditions of participation. Notably, however, Petitioner has offered no evidence or argument to challenge its alleged noncompliance with these conditions of participation. back to note 17 Back to top
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