Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Cedar Hills Geriatric Center
(CCN: 675931),
Petitioner,
v.
Centers for Medicare & Medicaid Services.
Docket No. C-20-463
Decision No. CR6322
DECISION
Cedar Hills Geriatric Center (Petitioner or the facility) challenges the determination by the Centers for Medicare & Medicaid Services (CMS) that it was not in substantial compliance with the Medicare program participation requirements at 42 C.F.R. § 483.25 (Tag F684). Petitioner also challenges the $12,250 per-instance civil money penalty (PICMP) CMS imposed. For the reasons discussed below, I find that Petitioner failed to comply substantially with the Medicare participation requirements found at 42 C.F.R. § 483.25. I further conclude that the PICMP imposed is reasonable.
I. Background and Procedural History
Petitioner is a skilled nursing facility (SNF) located in Camp Wood, Texas. See CMS Exhibit (Ex.) 1 at 1. Surveyors from the Texas Health and Human Services Commission (state agency) conducted a complaint investigation at Petitioner’s facility from January 30 to January 31, 2020. Id.; see also CMS Ex. 2 at 1.Based on the survey, the state agency found the facility out of substantial compliance with the following Medicare participation requirements: 42 C.F.R. §§ 483.20(e)(1)(2) (Tag F644) and 483.25 (Tag F684). CMS Ex. 1 at 1; see also CMS Ex. 2 at 1, 4. In a letter dated February 20, 2020,
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CMS stated that it agreed with the state agency’s findings of noncompliance. CMS Ex. 1 at 1. As a result, CMS imposed a $12,250 PICMP for the deficiency cited at Tag F684 concerning events on September 21, 2019. Id. at 2. CMS also noted that unless Petitioner returned to substantial compliance before July 31, 2020, Petitioner’s Medicare and Medicaid provider agreement would be terminated. Id. at 1. Finally, CMS imposed a Denial of Payment for New Admissions (DPNA) beginning February 27, 2020. Id. at 3. In a letter dated September 3, 2020, CMS notified Petitioner that the facility returned to substantial compliance on February 14, 2020. CMS Ex. 12 at 1. Therefore, both the proposed termination of Petitioner’s provider agreement and the DPNA were rescinded. Id.
Petitioner timely requested a hearing, and the case was assigned to me for a hearing and decision. My office acknowledged receipt of Petitioner’s hearing request and provided a copy of my Standing Prehearing Order (Prehearing Order). Pursuant to the Prehearing Order, CMS filed its Prehearing Brief and 11 proposed exhibits, including the written direct testimony of two witnesses. Petitioner filed a Prehearing Brief and 15 proposed exhibits, including the written direct testimony of one expert witness. Petitioner requested to cross-examine CMS’s proposed witnesses, Cindy LeMay, R.N. and Susana Cruz, R.N. Petitioner also objected to CMS Exs. 1-2 and 7-11. CMS requested to cross‑examine Petitioner’s proposed witness, Pearl Merritt, ED.D., MS, MSN, R.N., FAAN. CMS also objected to P. Exs. 1 and 5. On October 28, 2020, CMS filed a motion to supplement, along with CMS Ex. 12, a revised notice of enforcement action from CMS.
On October 5, 2021, I convened a telephone prehearing conference, the substance of which is summarized in my October 6, 2021 Summary of Prehearing Conference and Notice of Hearing (PHC Order). I overruled Petitioner’s objections to CMS Exs. 1, 2, 7, 8, and 11 and CMS’s objections to P. Ex. 5. I also reserved ruling on the admissibility of CMS Exs. 9 and 10 and P. Exs. 1 and 14 until the hearing. PHC Order at 2-4.
On December 13, 2021, I held a hearing by video teleconference and a transcript (Tr.) was made of the proceeding. I presided remotely from my home office in the greater Washington, D.C. area. Allison L. Spruill, Esq., represented Petitioner and appeared from Austin, Texas. Tr. at 7. Jason Meyer, Assistant Regional Counsel, represented CMS and appeared from Dallas, Texas. Id. At the hearing, I incorporated the rulings from my October 6th, 2021 PHC Order, and admitted CMS Exhibits 1-8, 11, and 12, and Petitioner’s Exhibits 2-13 and 15 into the record. Tr. at 11, 20. I admitted CMS Exhibits 9 and 10 and Petitioner’s Exhibit 14 into the record after the witnesses authenticated their written direct testimony. Tr. at 24, 82, 95. I admitted Petitioner’s Exhibit 1 into the record after determining the document had some relevance. Tr. at 32.
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Following the hearing, the parties filed post‑hearing briefs (CMS Post‑hrg. Br., P. Post‑hrg. Br.) and CMS filed a post‑hearing reply (CMS Reply). Petitioner waived its post-hearing reply.
II. Issue
The issues in this case are:
- Whether Petitioner was in substantial compliance with 42 C.F.R. § 483.25 (Tag F684); and
- If Petitioner was not in substantial compliance with Medicare participation requirements, whether the remedy imposed is reasonable.
III. Jurisdiction
I have jurisdiction to hear and decide this case. Social Security Act (Act) §§ 1128A(c)(2), 1819(h)(2)(B)(ii) (codified at 42 U.S.C. §§ 1320a-7a(c)(2), 1395i‑3(h)(2)(B)(ii)); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).
IV. Discussion
- Statutory and Regulatory Framework
The Act sets requirements for SNF participation in the Medicare program. The Act authorizes the Secretary of Health & Human Services (Secretary) to promulgate regulations implementing those statutory provisions. Act § 1819 (42 U.S.C. § 1395i-3). The Secretary’s regulations are found at 42 C.F.R. part 483.
To participate in Medicare, a facility must maintain substantial compliance with program requirements. To be in substantial compliance, a facility’s deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.” 42 C.F.R. § 488.301. A deficiency is a violation of a participation requirement established by sections 1819(b), (c), and (d) of the Act (42 U.S.C. § 1395i-3(b), (c), and (d)), or the Secretary’s regulations at 42 C.F.R. pt. 483, subpt. B. “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.” 42 C.F.R. § 488.301.
The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with the participation requirements. Act § 1864(a) (42 U.S.C. § 1395aa(a)); 42 C.F.R. §§ 488.10, 488.20. The Act and regulations require that facilities be surveyed on average every twelve months, and more often if necessary, to ensure that identified deficiencies are corrected. Act
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§ 1819(g)(2)(A) (42 U.S.C. § 1395i-3(g)(2)(A)); 42 C.F.R. §§ 488.20(a), 488.308. In addition to standard surveys, the Act and regulations require state agencies to investigate complaints that SNFs have violated Medicare participation requirements. Act § 1819(g)(4) (42 U.S.C. § 1395i-3(g)(4)); 42 C.F.R. §§ 488.332, 488.335. When the results of a survey or investigation show that a SNF is not in substantial compliance with program participation requirements, the Secretary may impose enforcement remedies such as CMPs. Act § 1819(h)(2) (42 U.S.C. § 1395i-3(h)(2)); 42 C.F.R. § 488.406.
If CMS imposes a CMP based on a noncompliance determination, then the SNF may request a hearing before an administrative law judge to challenge CMS’s determination of noncompliance that led to the imposition of an enforcement remedy. A SNF may challenge CMS’s finding as to the level of noncompliance only if a successful challenge would affect the range of CMP amounts imposed on the SNF. Act §§ 1128A(c)(2), 1819(h)(2)(B)(ii) (42 U.S.C. §§ 1320a‑7a(c)(2), 1395i‑3(h)(2)(B)(ii)); 42 C.F.R. §§ 488.330(e), 488.408(g)(1), 488.434(a)(2)(viii), 498.3(b)(13), (14); see also 5 U.S.C. §§ 554, 556. Further, where a challenge to the level of noncompliance is permitted, CMS’s determination as to the level of noncompliance must be upheld unless it is clearly erroneous. 42 C.F.R. § 498.60(c)(2).
In a hearing before an administrative law judge, CMS must make a prima facie case that the SNF failed to comply substantially with federal participation requirements. If CMS makes a prima facie case, the burden of persuasion shifts to the SNF, which must prove substantial compliance by a preponderance of the evidence. Hillman Rehab. Ctr., DAB No. 1611 (1997) (1997 WL 123708 at *4), aff’d sub nom. Hillman Rehab. Ctr. v. U.S. Dep’t of Health & Human Servs., No. Civ. A-98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999); Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff’d sub nom. Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App’x 181 (6th Cir. 2005); Emerald Oaks, DAB No. 1800 (2001); Cross Creek Health Care Ctr., DAB No. 1665 (1998).
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- Findings of Fact, Conclusions of Law, and Analysis1
- I find the following facts by a preponderance of the evidence based on my review of the record as a whole.
Resident 12
Resident 1 was admitted to Petitioner’s facility on August 9, 2019. P. Ex. 6 at 9. Upon admission, Resident 1 was 83 years old, with diagnoses that included: dementia with psychosis, anxiety, bipolar disorder, gastroesophageal reflux disease (GERD), muscle wasting, atrophy and hypertension. Id. A medication administration record documented that Resident 1 was prescribed and taking a variety of medications, including Plavix, a blood thinner. CMS Ex. 3; see also P. Ex. 14 at 4.
A nursing evaluation completed upon Resident 1’s admission to Petitioner’s facility listed Dr. John Preddy as Resident 1’s attending physician. P. Ex. 6 at 9. The nursing evaluation included a behavior checklist noting that Resident 1 was “verbally abusive” and “disruptive.” Id. However, the check box for “refuses care” was not marked. Id.
A care-plan conference summary dated September 5, 2019, noted that Resident 1 refused to participate in her care-plan conference and required continued use of antipsychotic medications due to delusions and verbal aggression. P. Ex. 10 at 1. According to the summary, Resident 1’s Brief Interview for Mental Status (BIMS) score was “0” indicating severe cognitive impairment.3 Id. Nursing notes from September 5 to September 15, 2019, documented Resident 1 frequently yelled loudly and disturbed others. P. Ex. 7 at 1. Staff were often unable to redirect Resident 1. Id. On September 15, 2019, staff on the 6 am to 2 pm shift documented that Resident 1 screamed for help but was unable to state what she needed help with. Id.
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Events of September 21, 2019
On September 21, 2019, at 9:00 am, Resident 1 had an unwitnessed fall from her wheelchair; she was found on the dining room floor with a small cut to her nose and bleeding from her nose.4 P. Ex. 6 at 1; P. Ex. 7 at 2; P. Ex. 9; P. Ex. 11 at 1, 7.
A nurse’s note timed 9/21/19 at 9:00 documented that neurological checks were in place, Resident 1’s vital signs were within normal limits, and she did not exhibit signs of pain or distress. P. Ex. 7 at 2.5
I interpret the nurse’s note to mean that, in accordance with Petitioner’s protocol for unwitnessed falls, staff initiated “serial neurological assessments” of Resident 1. See P. Ex. 11 at 1, 7. Serial neurological assessments included monitoring Resident 1’s blood pressure, temperature, pulse, respirations, and checking Resident 1’s pupil response. See CMS Ex. 4. Checking pupillary response involves assessing whether the patient’s pupils are equal, round, and reactive to light and accommodation (PERRLA). CMS Ex. 2 at 1, 5-7.
Between 9:15 am and 9:35 am, staff contacted Resident 1’s family, notified Petitioner’s Director of Nursing, and called Resident 1’s attending physician, Dr. Preddy. P. Ex. 6 at 1; P. Ex. 9. According to one of Petitioner’s nurses, when contacted, Dr. Preddy did not direct that Resident 1 be sent to the hospital for observation. P. Ex. 9. Instead, he directed staff to “continue to monitor” the resident. Id.
Resident 1’s Neurological Record, dated September 21, 2019, indicates that Resident 1’s blood pressure, temperature, pulse, and respirations were recorded at 9:00 am, 9:15 am, 9:30 am, 9:45 am, 10:15 am, 11:15 am, 12:15 pm, 1:15 pm, 2:15 pm, 3:15 pm, 4:15 pm and 5:15 pm. P. Ex. 8 at 1. However, the record also indicates that Resident 1’s pupil size and reactions were only measured at 9:00 am, 9:45 am, and finally at 5:15 pm.
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P. Ex. 8. At 9:15 am, 9:30 am, 10:15 am, 11:15 am, 12:15 pm, 1:15 pm, 2:15 pm, 3:15 pm, and 4:15 pm, the record contains no pupil size or reaction for Resident 1. Id. Instead, the record is marked with a circled “R,” indicating that the measurements were not completed.6 Id.
At the 5:15 neurological check, Resident 1’s left eye was relaxed enough for the Licensed Vocational Nurse (LVN) on duty to check her pupillary response. P. Ex. 7 at 2. At that point, the LVN noted that Resident 1’s left pupil was “constricted and non-reactive.” Id.
Around 5:30 pm, Resident 1 was transferred to the hospital where she was admitted to the intensive care unit, intubated, and diagnosed with an intracerebral hemorrhage. P. Ex. 6 at 2; P. Ex. 7 at 2; P. Ex. 11 at 4, 8; CMS Ex. 7 at 2. Resident 1 subsequently died at the hospital. CMS Ex. 2 at 7; CMS Ex. 7 at 2.
In a nurse’s note dated 9/21/19, one of Petitioner’s nurses wrote “[Resident 1] is normally confused and delusional [at] times, also does not follow commands so her refusing care is not out of her normal.” P. Ex. 7 at 2. I infer from the context of the note and its placement on the page that the writer entered it after Resident 1 had been sent to the hospital.
State Agency Investigations
On September 22, 2019, prior to Resident 1’s demise, Petitioner’s administrator reported Resident 1’s fall and subsequent hospitalization to the state agency. P. Ex 11. The incident report noted that Resident 1’s baseline mental status was “confused.” Id. at 7. As part of the investigation, Petitioner’s staff completed a pre-printed form titled “Provider Investigation Report.” Id. at 3-4. The staff member who completed the form checked boxes to indicate that Resident 1 required extensive supervision, had a history of verbal aggression, could not be interviewed, and lacked the capacity to make informed decisions. Id. at 3.
From October 15 to October 18, 2019, a state agency surveyor investigated Petitioner’s self-reported incident. P. Ex. 1; see also Tr. at 30-31. That investigation did not result in any deficiency citations related to the care Petitioner provided Resident 1. P. Ex. 1; Tr. at 31.
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In or around January 2020, the state agency received another complaint regarding the care provided to Resident 1. CMS Ex. 7 at 1; see also Tr. at 34. Based on that complaint, the state agency conducted a complaint investigation at Petitioner’s facility from January 30 to January 31, 2020. CMS Ex. 2. Investigator Nurse Surveyor Cindy LeMay (Surveyor LeMay) participated in the investigation. 7 CMS Ex. 9 at 2 (¶ 4). As part of the investigation, Surveyor LeMay collected documents, reviewed facility policies and procedures, and conducted interviews with staff; she documented her findings and observations in the statement of deficiencies (Form CMS-2567). Id. (¶ 5). Unless I explicitly state otherwise, I find that the statement of deficiencies and Surveyor LeMay’s notes accurately reflect the content of the interviews she conducted and the documents she reviewed.
Among the documents Surveyor LeMay reviewed was a policy titled “Emergency Treatment ‒ Head Injuries.” CMS Ex. 2 at 8. Petitioner’s head injury treatment policy specified that staff should “[e]valuate pupil size and reaction to light.” Id. Similarly, Petitioner’s “Neurological Assessment” policy provided:
Immediately following the injury/incident obtain vital signs, check the level of consciousness, mental status, speech, pupillary responses, motor and sensory functions to establish a baseline for future assessments.
Id.
On January 31, 2020, Surveyor LeMay interviewed one of Petitioner’s nurses, Kim Ives, LVN. CMS Ex. 8 at 2; see also CMS Ex. 2 at 7. Nurse Ives told Surveyor LeMay she was one of the staff members who performed neurological checks of Resident 1 on September 10, 2019. CMS Ex. 8 at 2. Nurse Ives stated that “she did not consider the [neurological] check to be complete without checking the pupils” and she “did not know why she did not notify the doctor that the resident would not open her eyes.” Id.
Also on January 31, 2020, Dr. Preddy, Resident 1’s attending physician, told Surveyor LeMay that “if he knew [Resident 1] had a head injury and . . . was an elderly person[,] he would send her out to the Emergency room.” Id. He noted that it is his job to “interpret data” and the nurses’ job “to report any changes.” Id. Dr. Preddy also stated that Resident 1’s unwillingness or inability to open her eyes for neurological checks could have been indicative of a status change. CMS Ex. 2 at 7; see also CMS Ex. 9 at 5‑6 (¶ 22).
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Surveyor LeMay’s investigation revealed that surveillance video of Resident 1’s fall was available. See CMS Ex. 8 at 1, 3. Surveyor LeMay reviewed the video images, which showed Resident 1 in the dining room reaching down toward the floor and “falling head first out of the [wheelchair].” Id. at 3.
In the following sections of this decision, I explain why I conclude the facts I have found above establish that Petitioner failed to comply substantially with Medicare participation requirements.
- Petitioner was not in substantial compliance with 42 C.F.R. § 483.25 (Tag F684) because it failed to perform complete neurological assessments following Resident 1’s unwitnessed fall and failed to notify Resident 1’s attending physician of its inability to conduct the assessments.
The quality of care regulation provides:
Quality of care is a fundamental principle that applies to all treatment and care provided to facility residents. Based on the comprehensive assessment of a resident, the facility must ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the resident’s choices[.]
42 C.F.R. § 483.25. Further, appellate decisions of the DAB have held that a facility may fail to comply with the quality of care regulation if it does not provide care consistent with its own policies.
Where a facility policy or a resident’s care plan requires staff to take specific measures in caring for a resident, the [DAB] has repeatedly held that those measures reflect the facility's own determination of what it must do to attain or maintain the resident’s ‘highest practicable physical, mental, and psychosocial well-being’ as required by the overarching quality-of-care requirement.
Heritage Plaza Nursing Ctr., DAB No. 2829 at 6 (2017); accord N. Las Vegas Care Ctr., DAB No. 2946 at 6 (2019); W. Tex. LTC Partners, DAB No. 2652 at 14 (2015) (holding that, at a minimum, the facility must follow its own policies and protocols), aff’d sub nom. W. Tex. LTC Partners, Inc. v. U.S. Dep’t of Health & Human Servs., 843 F.3d 1043 (5th Cir. 2016); Columbus Nursing & Rehab., DAB No. 2247 at 15 (2009); Green Oaks Health & Rehab. Ctr., DAB No. 2567 at 5 (2014) (holding that the measures described in
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a facility’s policies and care plans are evidence of what is required to attain or maintain residents’ highest practicable physical, mental, and psychosocial well-being).
Based on the regulations and prior DAB decisions, I find that Petitioner failed to ensure Resident 1 received treatment and care in accordance with professional standards of practice. Contrary to its own policies and procedures, Petitioner failed to ensure that Resident 1 received complete serial neurological assessments after she experienced an unwitnessed fall. Specifically, Petitioner failed to successfully perform a PERRLA exam 9 times over the course of the day: at 9:15 am, 9:30 am, 10:15 am, 11:15 am, 12:15 pm, 1:15 pm, 2:15 pm, 3:15 pm, and 4:15 pm. P. Ex. 8. Additionally, Petitioner failed to notify Resident 1’s attending physician that staff had been unable to complete the serial neurological assessments successfully.
Petitioner does not dispute that, per its policies and the standard of care, it was appropriate to initiate serial neurological checks for Resident 1 following her unwitnessed fall on September 21, 2019. P. Post-hrg. Br. at 4. Resident 1’s neurological record shows that it was Petitioner’s policy to check blood pressure, temperature, pulse, respirations – whether those respirations were normal or shallow/irregular, size and reaction for each pupil, eye responses, level of consciousness, speech, and motor response. P. Ex. 8. The neurological record indicates that the “frequency” of the checks is “per facility policy.” Id. The neurological checks were every 15 minutes for the first hour, beginning at 9:00 AM, and then every hour beginning at 10:15 AM. Id. However, Resident 1’s pupillary responses were only recorded for 9:00 AM and 9:45 AM. Id. For the 7.5 hours between 9:45 AM and 5:15 PM, Resident 1’s pupillary response was unmeasured, and the documentation indicates Resident 1 did not open her eyes. Id. Petitioner argues that “[n]eurological checks continued for Resident 1 throughout the day, and they were normal” but fails to account for the fact that the neurological checks were incomplete, because they did not include the PERRLA exam.8 See P. Post-hrg. Br. at 4. Surveyor LeMay testified that measuring pupillary response is an important part of the assessment because a change may signal increasing intracranial pressure. Tr. at 71.
Petitioner asserts that, upon assessing Resident 1 after her fall, Petitioner’s staff did not suspect that she had sustained a head injury. P. Post-hrg. Br. at 4. This assertion is a straw man. At the time of the incident, staff may not have known that Resident 1 had sustained a head injury; however, it is equally accurate to say staff could not have known that the resident did not have a head injury. See Tr. at 96. The purpose of performing repeated neurological checks is for precisely this reason: to detect and respond to any
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neurological changes that would signal a head injury and the need for more urgent treatment. Id. Thus, whether staff knew Resident 1 had a head injury or not does not alter the obligation to perform complete neurological assessments.
Petitioner next argues that it did not complete the PERRLA assessments because Resident 1 refused the examinations, as was her right. P. Post-hrg. Br. at 5. According to Petitioner, residents have the “right to refuse care or to refuse an assessment.” P. Post-hrg. Br. at 16; Tr. at 16. Petitioner contends Resident 1 refused the PERRLA assessment based on the fact she did not open her eyes for most of the attempted exams, and “the facility could not force the resident to open her eyes.” P. Post-hrg. Br. at 16; Tr. at 91-92. I acknowledge that residents of long-term care facilities generally have the right to refuse treatment. However, the record in this case does not establish, by a preponderance of the evidence, that Resident 1 affirmatively refused care on September 21, 2019.
Petitioner argues that Resident 1 frequently refused care and treatment and, accordingly, “[t]he fact that Resident 1 refused to open her eyes for several of the neurological assessments was not unusual for her.” P. Post-hrg. Br. at 8, 16. In support of the contention that refusing care was typical of Resident 1, Petitioner points to Resident 1’s “lengthy history” of refusing care, or not cooperating with facility staff. Id. at 5, 16. However, the examples Petitioner cites are open to interpretation. For example, the record documents instances where Resident would yell loudly and disturb others and display other “verbally abusive” and “disruptive” behavior. See P. Ex. 6 at 9; see also P. Ex. 7 at 1. However, these examples do not unequivocally demonstrate that Resident 1 was refusing care. Instead, these behaviors are equally consistent with outbursts attributable to her dementia. In fact, even when Petitioner had the opportunity to document that Resident 1 refused care, it did not. P. Ex. 6 at 9. I therefore find the evidence insufficient to establish that Resident 1 intended to refuse care when she squeezed her eyes shut during the attempted PERRLA exams on September 21, 2019.9
Importantly, even if Resident 1’s actions could be viewed as an attempt to refuse care, the record suggests that Resident l lacked the capacity to do so. See P. Ex. 10 at 1 (Resident 1’s BIMS score was “0”); see also P. Ex. 11 at 3 (resident lacked “[c]apacity to make informed decisions”). The appellate decision in Venetian Gardens explained that facilities have an obligation to make sure a resident’s refusal of care is informed: “This implies assessing what the potential consequences of refusal are and what alternatives
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could reasonably be offered that would not violate the resident’s rights.” DAB No. 2286 at 22 (2009); see also State Operations Manual, Appendix PP at F677, available at SOM - Appendix PP (cms.gov) (last visited July 20, 2023) (“decision to refuse care and treatment must be documented in the clinical record” “after efforts by the facility to inform and educate about the benefits/risks of the proposed care and treatment”) (the cited material appears at page 269 of the PDF file). The Venetian Gardens decision further stated that facilities may not escape deficiency findings by asserting, after the fact, that “demented or combative residents’ resistance to care were exercises of rights” to refuse care. DAB No. 2286 at 18. There is no evidence in the present record that any staff member attempted to explain to Resident 1 the reasons for requesting that she open her eyes. I infer, based on Petitioner’s own documentation, that staff did not attempt to explain the examination to Resident 1 because she was unable to meaningfully consent or refuse treatment. This reinforces my inference that Resident 1 did not have sufficient cognitive ability to knowingly refuse treatment. I further infer that Petitioner’s insistence that Resident 1 refused care was a justification created after the fact, once it was known that the resident experienced a poor outcome.10 I draw this inference based on the lack of documentation created prior to September 21, 2019, showing Resident 1 refused care or did so knowingly.
Moreover, regardless of whether Resident 1 was attempting to refuse care, when it became apparent that Resident 1 was unable or unwilling to open her eyes, Petitioner failed to promptly notify Resident 1’s attending physician of this change in condition. Resident 1’s attending physician, Dr. Preddy, told Surveyor LeMay that Resident 1’s unwillingness or inability to open her eyes for neurological checks could have indicated a status change and that staff should have notified him. CMS Ex. 2 at 7; see also CMS Ex. 9 at 5‑6 (¶ 22). Petitioner suggests that Dr. Preddy’s written statement disavows the statement he gave to Surveyor LeMay. P. Post‑hrg. Br. at 7. My reading of Dr. Preddy’s statement differs from Petitioner’s. In the written statement, Dr. Preddy admitted he did not recall Resident 1 and that his answers were based on facts related by the surveyor. P. Ex. 12. He did not deny telling the surveyor that Resident 1 “not wanting to open her eyes could have been a change.” Id. Rather, he elaborated, “I would add to that statement that I said change in mental status.” Id. I therefore find it more likely than not that the statement of deficiencies accurately recounts Dr. Preddy’s statement. I further find that his statement to Surveyor LeMay, as amplified by his written statement, supports the conclusion that he believed staff should have reported to him that Resident 1 was refusing to open her eyes. This failure to promptly notify the physician upon a resident’s change in condition is another basis to find that Petitioner failed to comply substantially with 42 C.F.R. § 483.25. See, e.g., Magnolia Estates Skilled Care, DAB No. 2228 at 21 (2009) (failure to notify physician that delayed resident receiving
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necessary medical treatment represented a failure to comply with section 483.25); see also Emery Cty. Care & Rehab. Ctr., DAB No. 3006 at 12 (2020) (staff’s failure to notify physician of change in condition violated both sections 483.24 and 483.25).
In addition to contending that it was not required to complete PERRLA assessments either because it was unclear Resident 1 had suffered a head injury or because she refused care, and that staff were not required to notify the resident’s physician, Petitioner argues that CMS is precluded from finding noncompliance based on Surveyor LeMay’s January 2020 investigation. Petitioner suggests that the January 2020 investigation was improper because the state agency had investigated the incident involving Resident 1 in October 2019, finding no deficiencies. P. Post-hrg. Br. at 3; see also P. Ex. 1; Tr. at 30-31, 33. Petitioner states, “[t]here was no legitimate reason for [the state agency] to investigate the Resident 1 incident twice, much less three separate times.” P. Post-hrg. Br. at 3.
Petitioner’s argument is without merit. Petitioner fails to cite any legal authority that prohibits a state agency from conducting multiple surveys or investigations, and I am aware of none. To the contrary, the regulations require state agencies to establish policies and procedures for investigating complaints and to investigate any such complaints in accordance with those policies and procedures. 42 C.F.R. §§ 488.332, 488.335. Nothing in the record supports a conclusion that Surveyor LeMay’s investigation failed to comply with a state agency policy or procedure.11 Indeed, the evidence leads to the opposite conclusion. Surveyor LeMay testified at the hearing that her investigation in January 2020 was triggered by a new complaint (i.e., a different complaint than the one investigated in October 2019), which prompted a separate investigation. Tr. at 71-72.
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I find Surveyor LeMay’s testimony credible.12 I therefore find nothing improper in the process that led the state agency to recommend findings of noncompliance.
Moreover, even if the survey process were somehow flawed ‒ a finding I do not make ‒ that would not change my conclusion that Petitioner failed to comply substantially with 42 C.F.R § 483.25. That is because any alleged failure of the state agency to conform to the correct survey process is not an issue subject to my review. Rather, the only issues properly before me are whether Petitioner was in substantial compliance with Medicare participation requirements and, if not, whether the CMP imposed is reasonable. See Oaks of Mid City Nursing & Rehab. Ctr., DAB No. 2375 at 33 (2011). Because these are the only issues I may hear and decide, “the quality of the surveyors’ information gathering or thought processes is immaterial.” Id.
Additionally, any alleged failing by the state agency to follow proper procedures would not affect CMS’s authority to issue findings of noncompliance and impose remedies. This is because the state agency’s role is to recommend citations and remedies to CMS. See Act § 1819(h)(1); see also 42 C.F.R. § 488.12. DAB decisions consistently interpret these authorities to mean that CMS, not the state agency, makes the determination of compliance or noncompliance. See, e.g., Avon Nursing Home, DAB No. 2830 at 14 (2017) (“a state agency’s survey findings constitute recommendations to CMS.”) (emphasis in original); Britthaven of Chapel Hill, DAB No. 2284 at 6-7 (2009) (state agency merely recommends a finding of compliance or noncompliance; CMS ultimately determines whether the facility is in substantial compliance). As these decisions make clear, nothing in the Act or regulations bars CMS from deciding to cite a deficiency not previously recommended by the state agency surveyors. Nor can Petitioner plausibly argue that it was unfairly surprised by the noncompliance determination, since CMS’s February 20, 2020 notice letter informed Petitioner of CMS’s determination. See CMS Ex. 1. I therefore find that any factual dispute related to the survey process is not material to my decision.
In summary, Petitioner failed to conduct complete neurological assessments for Resident 1 as required by professional standards of practice and the facility’s own policies and procedures. Petitioner failed to check Resident 1’s pupil size and reaction for 7.5 hours. Further, Petitioner’s staff failed to notify Resident 1’s physician that staff were unable to complete the assessments because the resident would not open her eyes. These deficient practices posed the risk of more than minimal harm to Resident 1 because they had the
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potential for delaying the resident’s transfer to the hospital for treatment of her intracerebral hemorrhage. CMS Ex. 9 at 6 (¶ 28); see also P. Ex. 11 at 1. Accordingly, Petitioner failed to comply substantially with 42 C.F.R. § 483.25.
- The remedy imposed, a $12,250 PICMP for the September 21, 2019 deficiency cited, is reasonable.
I have concluded that Petitioner failed to comply substantially with 42 C.F.R. § 483.25. I next explain why I conclude the PICMP imposed for Petitioner’s noncompliance is reasonable.
When reviewing the CMP amount, I apply the factors listed in 42 C.F.R. § 488.438(f): 1) the facility’s history of noncompliance; 2) the facility’s financial condition; 3) the factors specified in 42 C.F.R. § 488.404; and 4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety. The absence of culpability is not a mitigating factor. The factors listed in section 488.404 include: 1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies.
The regulations specify that a PICMP will fall into a single range of penalties. 42 C.F.R. §§ 488.408, 488.438. The range is from $1,000 per instance to $10,000 per instance, adjusted for inflation under 45 C.F.R. pt. 102. 42 C.F.R. § 488.438(a)(2). The adjusted amounts applicable in this case are $2,233 per instance to $22,320 per instance. 45 C.F.R. §§ 102.2, 102.3; see 85 Fed. Reg. 2869, 2880 (Jan. 17, 2020). The regulations leave the decision regarding the choice of remedy to CMS and the amount of the remedy to CMS and the administrative law judge, requiring only that the regulatory factors at sections 488.438(f) and 488.404 be considered when determining the amount of a CMP within a particular range. 42 C.F.R. §§ 488.408, 488.408(g)(2), 498.3(d)(11); see also 42 C.F.R. § 488.438(e)(2), (3); Alexandria Place, DAB No. 2245 at 27 (2009); Kenton Healthcare, LLC, DAB No. 2186 at 28-29 (2008). Unless a facility contends that a particular regulatory factor does not support the CMP amount that CMS has imposed, the administrative law judge must sustain it. Coquina Ctr., DAB No. 1860 (2002) (2002 WL 31985890 at *18).
Here, CMS imposed a $12,250 PICMP, which falls near the middle of the CMP range in effect at the time CMS imposed the remedy. 42 C.F.R. § 488.438(a)(2); 85 Fed. Reg. at 2880. CMS argues primarily that the PICMP imposed is reasonable because it is in the “mid-range” of the permitted penalty range and because of the severity of Petitioner’s noncompliance, which caused harm to Resident 1. CMS Post-hrg. Br. at 15. Petitioner did not argue against any of the regulatory factors set forth above. P. Post-hrg. Br. at 1, 8. Instead, Petitioner argues that it was “in substantial compliance with the
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regulation forming the basis of tag F684,” and, therefore, there is no basis to uphold CMS’s proposed PICMP. Id. at 1, 8.
For the reasons explained in the earlier sections of this decision, I have rejected Petitioner’s contention that it complied substantially with 42 C.F.R. § 483.25. I reject Petitioner’s contention that the PICMP is unreasonable for similar reasons. First, I conclude that Petitioner’s noncompliance was serious and caused harm to a resident. Resident 1 ultimately died after suffering an intracerebral hemorrhage. Further, Petitioner was culpable for the noncompliance. Under the regulation, culpability includes neglect or indifference. 42 C.F.R. § 488.438(f)(4). Here, Petitioner’s staff neglected to inform Resident 1’s physician of a change in her condition. Each of these factors, whether viewed separately or in tandem, supports the imposition of a PICMP in the middle of the permitted range. Based on the seriousness of Petitioner’s noncompliance and Petitioner’s culpability, I conclude that the $12,250 PICMP is reasonable.
V. Conclusion
For the foregoing reasons, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25. The $12,250 per-instance CMP for the September 21, 2019 deficiency cited at Tag F684 is reasonable.
Endnotes:
1 My conclusions of law appear as headings in bold italic type; my findings of fact are set out in the accompanying text.
2 To protect her privacy, I refer to the resident by the numerical identifier assigned during the survey. See CMS Ex. 2 at 4.
3 BIMS scores are categorized into 3 levels: cognitively intact (13-15), moderately impaired (8-12), and severe impairment (0-7). See Long-Term Care Facility Resident Assessment Instrument 3.0 User’s Manual, Ch. 3 (Overview to the Item-by-Item Guide to the MDS 3.0), § C0500 (Summary Score)), https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/Downloads/MDS-30-RAI-Manual-V113.pdf (last visited July 19, 2023) (the cited material appears at page 168 of the PDF file).
4 Petitioner contends that the blood on Resident 1’s face was from the cut on her nose and not from her nostril. P. Post-hrg. Br. at 4 n.3, 10 n.5. However, Petitioner’s own investigation report described Resident 1 as bleeding “from her nose” or “from her right nostril.” P. Ex. 11 at 1, 7. I therefore find it more likely than not that Resident 1 had blood coming from her nostril following the fall. Nevertheless, even if Resident 1 only suffered a cut to her nose, this would not change any part of my analysis of Petitioner’s noncompliance.
5 In several instances, the record includes duplicate copies of documents. For example, CMS Ex. 5 and P. Ex. 7 at 2 are duplicates. Similarly, CMS Ex. 4 and P. Ex. 8 are duplicates and CMS Ex. 6 is a duplicate of P. Ex. 11 at 1. In this decision, I cite to the copies Petitioner offered because they are more legible.
6 Petitioner states that the circled “R” was shorthand for “refused,” indicating that Resident 1 refused to open her eyes. See, e.g., P. Post-hrg. Br. at 4. I accept Petitioner’s representation that this is what staff intended to convey. However, as I discuss in more detail below, I do not find that Resident 1 intended to refuse care on these occasions.
7 Surveyor LeMay was not the surveyor who conducted the investigation in October 2019. See P. Ex. 1; see also Tr. at 30-31.
8 Petitioner argues that CMS ignores and “inexplicably” “overlooks” the fact Resident 1’s vital signs ‒ her blood pressure, temperature, pulse, and respirations, were stable throughout the day. P. Post-hrg. Br. at 5. However, Petitioner fails to acknowledge that even when Resident 1’s left pupil eventually appeared “constricted and non-reactive,” her other vital signs remained stable. CMS Ex. 5; see also Tr. at 98.
9 Petitioner points to no evidence of prior instances in which Resident 1 clearly and knowingly refused care. At best, the evidence equally supports inferences that the resident may have intended to refuse care or may have been combative with care as a symptom of her dementia. Where evidence is in equipoise, Petitioner fails to carry its burden to establish compliance by a preponderance of the evidence. Hillman Rehab. Ctr., DAB No. 1611 (1997 WL 123708 at *4).
10 To the extent Petitioner relies on the testimony of its nursing expert regarding a resident’s right to refuse care, I note that Dr. Merritt nowhere opines on Resident 1’s capacity to refuse care. Therefore, I accord her testimony on this point little weight.
11 Petitioner points to an unsworn statement by its former administrator, describing a third investigation of the facility which the state agency apparently conducted on February 19‑20, 2020. See P. Ex. 5. The statement, which is itself hearsay, recounts a conversation between the administrator and another state agency surveyor. According to Petitioner’s administrator, the surveyor stated she did not think it was necessary to investigate the incident involving Resident 1 because that incident had already been investigated and resolved. Id. Petitioner seems to imply that the surveyor was describing a policy or practice of the state agency not to investigate the same incident on more than one occasion. P. Post‑hrg. Br. at 2-3. I note that, because the investigation described in P. Ex. 5 occurred after Surveyor LeMay’s investigation in January 2020, the surveyor who made the alleged statement in February may have meant that she did not need to investigate again because the January investigation had disposed of the issue. I accord P. Ex. 5 little weight because the statement is double hearsay and is inconsistent with other evidence. Moreover, the point is of marginal relevance for the reasons discussed in the text above.
12 I note that the incident and complaint numbers which were the subject of the October 2019 investigation are different than those that Surveyor LeMay investigated in January 2020. Compare P. Ex. 1 with CMS Ex. 2 at 1. Further, while the record suggests that the October 2019 investigation found allegations of abuse and neglect unsubstantiated (P. Ex. 1), Surveyor LeMay did not cite a deficiency for abuse or neglect following her January 2020 investigation. CMS Ex. 2.
Leslie A. Weyn Administrative Law Judge