The Legacy at Willow Bend, CR6278 (2023)

DECISION

The Centers for Medicare & Medicaid Services (CMS) moves for summary judgment on its allegations that The Legacy at Willow Bend (Petitioner or facility) was not in substantial compliance with Medicare participation requirements at 42 C.F.R. §§ 483.45(f)(2) and 483.70(i) and that the per-instance civil money penalties (PICMPs) CMS imposed as remedies for Petitioner’s alleged noncompliance are reasonable in amount.  Petitioner contests these allegations and opposes summary judgment. 

I conclude that summary judgment is appropriate in this case because the undisputed facts, even when viewed in the light most favorable to Petitioner, establish that:  1) Petitioner did not substantially comply with the Medicare participation requirements found at 42 C.F.R. §§ 483.45(f)(2) and 483.70(i); and 2) the imposed PICMPs are reasonable in amount.  I therefore grant CMS’s motion for summary judgment.

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I.     Background and Procedural History

Petitioner is a skilled nursing facility (SNF) located in Plano, Texas.¹  See, e.g., CMS Exhibit (Ex.) 1.  Surveyors from the Texas Department of Health and Human Services (state agency) conducted a survey of Petitioner’s facility from August 21-24, 2020 (the August survey).  CMS Ex. 2 at 1; see also P. Ex. 1.  During the August survey, the state agency found the facility out of substantial compliance with the following Medicare participation requirements:  42 C.F.R. §§ 483.10(g)(14)(i)-(iv), (15) (Tag F580); 483.45(a), (b)(1)-(3) (Tag F755); and 483.20(f)(5), 483.70(i)(1)-(5) (Tag F842).  CMS Ex. 2 at 1; see also P. Ex. 1.  From October 15-20, 2020, the state agency conducted a follow-up survey (the October survey) and found that the facility was not in substantial compliance with the following Medicare participation requirements, all at the immediate jeopardy level:  42 C.F.R. §§ 483.12(a)(1) (Tag F600); 483.25 (Tag F684); 483.45(f)(2) (Tag F760); and 483.20(f)(5), 483.70(i)(1)-(5) (Tag F842).  CMS Ex. 2 at 1; see also CMS Ex. 1.  Both the August and October surveys investigated incidents that occurred in August of 2020.  Compare CMS Ex. 1 with P. Ex. 1. 

In a letter dated November 4, 2020, CMS stated that it agreed with the state agency’s findings of the October 20, 2020 survey.  CMS Ex. 2 at 1.  As a result, CMS imposed two PICMPs for Petitioner’s alleged noncompliance:  one for the deficiency cited at Tag F842 concerning events on August 18, 2020, and one for the deficiency cited at Tag F760 concerning events on August 19, 2020.  Id. at 2.  Each PICMP was for $14,390.  Id.  CMS also imposed a Denial of Payment for New Admissions (DPNA) from November 18, 2020, through November 22, 2020, when Petitioner achieved substantial compliance.  Id. at 3; see also CMS Ex. 3 at 1. 

Petitioner timely requested a hearing, and the case was assigned to me. 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, the parties filed pre-hearing exchanges, including prehearing briefs (CMS Br. and P. Br., respectively), exhibit and witness lists, and proposed exhibits.  Within its prehearing brief, CMS moved for summary judgment, which Petitioner opposed in its own prehearing brief. 

Though not styled as a cross-motion for summary judgment, Petitioner’s brief asserts that I should grant Petitioner summary judgment as to certain deficiencies because CMS did not address them in its brief.  P. Br. at 9-10.  However, Petitioner acknowledges that CMS did not impose any enforcement actions based on those deficiencies.  Id. at 9.  Facilities such as Petitioner have the right to appeal a “finding of noncompliance leading

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to the imposition of enforcement actions specified in [42 C.F.R.] § 488.406 [e.g., civil money penalties, denial of payment for new admissions] or § 488.820.”  42 C.F.R. § 498.3(b)(13) (emphasis added).  Similarly, 42 C.F.R. § 488.408(g)(1) provides that “[a] facility may appeal a certification of noncompliance leading to an enforcement remedy.”  Because CMS did not impose an enforcement action based on the deficiencies to which Petitioner refers, Petitioner has no right to administrative review of those findings.  See, e.g., Generations at Regency Center, DAB No. 2950 at 6-7 (2019).  I therefore deny Petitioner’s request for summary judgment. 

CMS submitted 31 exhibits (CMS Exs. 1-31), and Petitioner submitted eight exhibits (P. Exs. 1-8).  As neither party has objected to any of the proposed exhibits, I admit all of them into the record. 

II.    Issues

The issues in this case are: 

1. Whether summary judgment is appropriate;
2. Whether Petitioner failed to comply substantially with Medicare participation requirements; and
3. If Petitioner was not in substantial compliance, whether the remedies imposed are 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

1. 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

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greater risk to resident health and safety than “the potential for causing minimal harm.”  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 § 1819(g)(2)(A) (42 U.S.C. § 1395i-3(g)(2)(A)); 42 C.F.R. §§ 488.20(a), 488.308. 

2. Findings of Fact, Conclusions of Law, and Analysis
   1. Summary judgment is appropriate.²

Summary judgment is appropriate if there is “no genuine issue as to any material fact, and the moving party is entitled to judgment as a matter of law.”  Mission Hosp. Reg’l Med. Ctr., DAB No. 2459 at 5 (2012) (citations omitted), aff’d on other grounds, Mission Hosp. Reg’l Med. Ctr. v. Burwell, 819 F.3d 1112 (9th Cir. 2016).  To prevail on a motion for summary judgment, the moving party must show that there is no genuine dispute of material fact requiring an evidentiary hearing and that it is entitled to judgment as a matter of law.  Id.  If the moving party meets this initial burden, the non-moving party must “come forward with ‘specific facts showing that there is a genuine issue for trial . . . .’”  Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986) (quoting Fed. R. Civ. Pro. 56(e)).  “To defeat an adequately supported summary judgment motion, the non-moving party may not rely on the denials in its pleadings or briefs, but must furnish evidence of a dispute concerning a material fact – a fact that, if proven, would affect the outcome of the case under governing law.”  Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300 at 3 (2010), aff’d, Senior Rehab. & Skilled Nursing Ctr. v. Health & Human Servs., 405 F. App’x 820 (5th Cir. 2010). 

In evaluating a motion for summary judgment, an administrative law judge does not address credibility or evaluate the weight of conflicting evidence.  Holy Cross Village at Notre Dame, Inc., DAB No. 2291 at 5 (2009).  Rather, in examining the evidence to determine the appropriateness of summary judgment, an administrative law judge must draw all reasonable inferences in the light most favorable to the non-moving party.  See Brightview Care Ctr., DAB No. 2132 at 9-10 (2007) (upholding summary judgment where inferences and views of non-moving party are not reasonable). “[A]t the summary judgment stage the judge’s function is not . . . to weigh the evidence and determine the truth of the matter, but to determine whether there is a genuine issue for trial.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249 (1986).  However, drawing factual inferences in the light most favorable to the non-moving party does not require that I accept the non-

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moving party’s legal conclusions.  Cedar Lake Nursing Home, DAB No. 2344 at 7 (2010). 

Petitioner opposes summary judgment, arguing there are disputes of material fact because the August survey and the October survey cited different deficiencies at different scope and severity, based on the same facts.  See P. Br. at 15.  Petitioner’s argument is not a basis to deny summary judgment.  Petitioner implicitly concedes that the facts underlying the deficiencies are undisputed;³ the dispute concerns whether those facts support the deficiencies cited at the October survey.  Whether certain facts support a particular deficiency citation is not a question of fact, but one of law.  See Lake Park Nursing & Rehab. Ctr., DAB No. 2035 (2006) (2006 WL 2382924 at *11) (witness’s opinion “that a facility should not be cited for a deficiency . . . or . . . for immediate jeopardy” is a “legal conclusion[], not evidence.”).  As such, it is a question I may properly address on summary judgment.  

Moreover, to the extent Petitioner raises a dispute of fact, the dispute concerns the process undertaken by the state agency during the October survey.  However, the regulations are clear that “inadequate survey performance does not . . . [i]nvalidate adequately documented deficiencies.” 42 C.F.R. § 488.318(b)(2).  As one appellate decision of the Departmental Appeals Board (DAB) explains: 

[U]nder the governing administrative appeal regulations, the ultimate issue before an [administrative law judge] is not how the state agency performed the survey or what process it followed to reach its conclusions, but “whether the evidence as it is developed before the [administrative law judge] supports” CMS’s independent “finding of noncompliance” under the relevant participation requirements. 

Avon Nursing Home, DAB No. 2830 at 11 (2017) (emphasis in original) (citing Sunshine Haven of Lordsburg, DAB No. 2456 at 21 (2012), aff’d in part and transferred, Sunshine Haven Lordsburg v. U.S. Dept. of Health & Human Servs., 742 F.3d 1239 (10th Cir.

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2014)).  I therefore find that any factual dispute related to the survey process is not material to my decision.⁴

2. I find the following facts are undisputed.

The documents in the record establish the following undisputed facts. 

Resident D.C.⁵

On August 18, 2020, D.C. was admitted to Petitioner’s SNF with a primary diagnosis of COVID-19.  CMS Ex. 10 at 1.  On admission, D.C. was 93 years old.  Id.  Among other drugs, D.C. was prescribed Mirtazapine for depression and Quetiapine Fumarate for vascular dementia with behavioral disturbance.  CMS Ex. 16 at 5. 

Resident A.W.

Like D.C., A.W. was admitted to Petitioner’s SNF on August 18, 2020.  CMS Ex. 24 at 1; see also CMS Ex. 25 at 3.  On admission, A.W. was 78 years old, with diagnoses that included:  diabetes, dementia, depression, and cerebrovascular accident (CVA) with hemiparesis and aphasia.  CMS Ex. 24 at 1; CMS Ex. 25 at 3.  A.W. had a Brief Interview for Mental Status (BIMS) score of 3 out of 15, demonstrating that he had

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severely impaired cognition.⁶  CMS Ex. 24 at 8.  A.W. further required extensive assistance with all activities of daily living.  Id. at 9.  A.W. was prescribed Metformin HCL for diabetes, Tradjenta for diabetes, Valsartan for hypertension, and Sertraline for depression.  CMS Ex. 9 at 8-10.  A.W.’s physician also ordered staff to check A.W.’s fasting blood sugar once per day.  CMS Ex. 9 at 1, 3.  Prior to August 18, 2020, A.W.’s diabetes was well-controlled with diet and medication and did not require insulin injections.  CMS Ex. 8 at 10; CMS Ex. 25 at 4; see also CMS Ex. 6 at 3 (A.W.’s family reports diabetes (DM) usually controlled on Metformin).  Like D.C., A.W. was COVID-positive upon admission.  CMS Ex. 24 at 1. 

Events of August 2020⁷

As discussed above, both D.C. and A.W. were COVID-positive on admission to Petitioner’s SNF on August 18, 2020.  CMS Ex. 10 at 1; CMS Ex. 24 at 1.  In fact, D.C. and A.W. were admitted to Petitioner’s SNF from the separate memory care unit because they tested positive for COVID-19.⁸  CMS Ex. 6 at 2; CMS Ex. 31 at 2.  According to Petitioner’s director of nursing, these were the first COVID transfers on Petitioner’s campus.  CMS Ex. 6 at 2.  According to Petitioner’s administrator, staff were rushing to get the residents moved out of the memory care unit because of the risk COVID-19 would spread to other memory care residents.  Id.  Staff did not complete transfer paperwork for the residents and brought them in through a side entrance.  Id.  The

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residents were brought in without identifying information.  Id.; see also CMS Ex. 31 at 2‑3. Further, staff caring for D.C. and A.W. did not initially receive orders for the residents.  CMS Ex. 6 at 2. The facility’s internet was down at the time and staff were unable to access residents’ electronic medical records from the memory care unit.  Id.; see also CMS Ex. 31 at 2.Later, staff were able to print out paper orders.  CMS Ex. 6 at 2.  However, pictures of D.C. and A.W. did not transfer from the memory care unit to the SNF through the electronic system.  CMS Ex. 31 at 3, 94, 102.  In addition, staff who brought D.C. and A.W. to the SNF placed them in different rooms from the ones listed in their paperwork.  CMS Ex. 6 at 2; see also CMS Ex. 10 at 1.  D.C. and A.W. received no medications on the evening of August 18, 2020.  CMS Ex. 6 at 1, 5; see also CMS Ex. 1 at 7. 

Sometime late on August 18 or early on August 19, 2020, Petitioner’s staff sent D.C. to the hospital emergency department for respiratory decline.  CMS Ex. 6 at 1.  However, likely due to a combination of the factors described in the previous paragraph, Petitioner’s staff confused the identities and medical records of D.C. and A.W.  Id.  Because of this error, Petitioner sent D.C. to the emergency department with A.W.’s identity and paperwork, while A.W. stayed at Petitioner’s facility with D.C.’s identity and paperwork.  Id.  Accordingly, Petitioner and the emergency department believed that it was A.W., not D.C., who was sent to the hospital.  Id. 

At around midnight on August 19, 2020, a member of Petitioner’s staff informed A.W.’s family that A.W. was transferred to the emergency department for respiratory distress.  CMS Ex. 6 at 11.  A.W.’s family inquired how this was possible when he was “asymptomatic only [six] hours before.”  Id.  In the early hours of August 19, 2020, an emergency department nurse informed the family that A.W. was being treated for fever, difficulty breathing, and COVID pneumonia.  Id. at 12.  The hospital inquired if A.W. had a do not resuscitate order and whether to place him on a respirator.  Id. The hospital also informed the family that A.W. would be treated as a full code.  Id.  The hospital contacted the family again around 3 am to inquire what life-saving measures it should take.  Id.  Around 3:30 am, the family was able to contact A.W.’s wife, a resident of Petitioner’s assisted living facility, to inform her what was happening with her husband.  Id.  A.W.’s family reported that she was hysterical and inconsolable.  Id. 

Around 6 am on August 19, the emergency department nurse informed A.W.’s family that he was stabilized and would be moved to the ICU.  Id.  Around noon, ICU staff informed the family that A.W. was doing well.  Id. at 13.  Around 9 pm A.W.’s family was able to speak with the patient believed to be A.W.  Id.  The family reported that the patient with whom they spoke “didn’t sound like [their father] at all,” as “his voice was weak and sounded very high-pitched.”  Id. 

Around 9:15 am on August 20, 2020, A.W.’s family called the hospital for an update.  Id. at 14.  A hospital employee told the family they needed to speak with Petitioner’s

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administrator and gave them her cell phone number.  Id.  When reached by phone, the administrator informed A.W.’s family that A.W. had never left the facility, that A.W. was fine, and that a different resident was taken to the hospital.  Id.  The administrator explained that Petitioner mixed up the identities of the two residents and that A.W. had been administered D.C.’s medications for two days.  Id. 

Because of the mix-up of identities, Petitioner treated A.W. according to D.C.’s care plan meaning that A.W. did not receive any of his medications and, instead, received D.C.’s medications, including:  Aspirin, Ferrous Sulfate, Gabapentin, Quetiapine Fumarate, Ropinirole HCL, Tamsulosin HCL, Metoprolol Tartrate, and Tervinafine HCL cream.  Id. at 18-19.  Because he did not receive his diabetes medications, A.W.’s blood sugar levels were elevated for days.  Id. at 20, 23; CMS Ex. 8 at 16, 20; CMS Ex. 25 at 1‑2; CMS Ex. 31 at 125, 126.  On August 20, 2020, A.W. had a blood sugar level of 378 and was prescribed regular (injected) insulin of 15 units.  CMS Ex. 31 at 126.  Previously, A.W. had not required insulin injections as his diabetes was well-controlled with diet and oral medications.  CMS Ex. 6 at 3 (A.W.’s family reports diabetes (DM) usually controlled on metformin); CMS Ex. 25 at 4; CMS Ex. 31 at 95 (A.W.’s physician prescribed only oral DM medications).  A.W.’s blood sugar and blood pressure were elevated through August 31, 2020.  CMS Ex. 8 at 7, 16, 20.  A.W.’s physician continued to treat him with injected insulin for several days.  See, e.g., CMS Ex. 31 at 115. 

Similarly, because Petitioner’s staff believed that D.C. was A.W., staff recorded observations and treatments for D.C. in A.W.’s medical record until D.C. was transferred to the hospital.  This is apparent, for example, where a change in D.W.’s condition (shortness of breath at 12:30 am on August 19) was entered in A.W.’s medical record and later stricken out with the notation “Wrong Chart.”  CMS Ex. 31 at 126-27.  D.C. ultimately died in the hospital of COVID complications on August 24, 2020.  CMS Ex. 7 at 1. 

The state agency conducted a complaint investigation at Petitioner’s SNF from August 21-24, 2020.  CMS Exs. 30, 31; see also P. Ex. 1.  As part of the August survey, Petitioner’s staff provided a surveyor with copies of various facility policies.  CMS Ex. 30 at 2 (¶ 5).  Among the policies was a policy titled “Resident Identifiers.”  CMS Ex. 31 at 58.  Petitioner’s Resident Identifiers policy provides, in part:  “Upon admission and prior to the administration of care, use at least two identifiers to verify Resident’s identity, neither of which should be the resident’s room number.”  Id. (bold type omitted, underscore in original).  The first suggested method of identification is to “[c]ompare resident with picture in electronic chart.”  Id. 

In the following sections of this decision, I explain why I conclude that the undisputed facts I have found above establish that Petitioner failed to comply substantially with Medicare participation requirements.

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3. Petitioner was not in substantial compliance with Medicare participation requirements. 
   1. Petitioner was not in substantial compliance with 42 C.F.R. § 483.45(f)(2) (F760) because it failed to ensure its residents were free from significant medication errors. 

42 C.F.R. § 483.45(f)(2) states that SNFs must ensure that residents are free of “any significant medication errors.”  CMS defines “medication error” to include administering medication that “is not in accordance with . . . [t]he prescriber’s order[.]” State Operations Manual (SOM), CMS Pub. 100-07, Appendix PP, at 592.⁹  CMS further instructs that a “‘significant medication error’ means one which causes the resident discomfort or jeopardizes his or her health or safety.”  Id.  Among the factors to consider when deciding if a medication error is significant are the resident’s condition (i.e., did the resident suffer negative consequences as a result of the error) and the frequency of error (i.e., did the error occur several times).  Id. at 593.  Consistent with this guidance, DAB decisions hold that evidence of a significant medication error supports a finding of noncompliance with § 483.45(f)(2) without regard to whether there is evidence of a pattern of errors.  Franklin Care Center, DAB No. 1900 (2003) (2003 WL 23142158 at *5).  Further, a showing of actual harm is not required to find that a medication error was significant.  Life Care Center of Tullahoma, DAB No. 2304 at 35 (2010), aff’d, Life Care Ctr. Tullahoma v. Secretary of U.S. Dep’t of Health & Human Servs., 453 F. App`x 610 (6th Cir. 2011); Rosewood Care Center of Peoria, DAB No. 1912 (2004) (2004 WL 714963 at *4-*5).¹⁰

Based on the regulations, SOM guidance, and prior DAB decisions, I find that Petitioner failed to ensure that A.W. was free of significant medication errors.  First, for two days, A.W. did not receive his medications and instead received D.C.’s medications.  This

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represents a medication error because A.W. did not receive the medications his physician had prescribed.  Second, the error was significant because A.W. suffered negative consequences as a result, including elevated blood pressure levels and elevated blood sugar levels requiring injected insulin, which he did not require previously.  See CMS Ex. 31 at 126. 

Petitioner does not dispute any of the above.  Instead, Petitioner argues it did not commit a significant medication error while treating D.C.  P. Br. at 14-15.  I disagree.  As was true for A.W., D.C. did not receive any of his medications the evening of August 18, 2020, which I find to be a significant medication error in and of itself.¹¹  But even if I viewed Petitioner’s failure to administer any medications to D.C. on August 18 as insignificant, the medication errors Petitioner committed while caring for A.W. are more than sufficient to establish that Petitioner failed to comply substantially with 42 C.F.R. § 483.45(f)(2).  Put another way, CMS is not required to establish that more than one resident was the subject of significant medication errors to establish a violation of 42 C.F.R. § 483.45(f)(2). 

However, Petitioner’s main argument opposing CMS’s citation of noncompliance is that CMS is precluded from finding noncompliance with 42 C.F.R. § 483.45(f)(2) based on the October revisit survey because the statement of deficiencies for the August survey did not cite a deficiency based on that regulation.  P. Br. at 15.  Petitioner’s argument is without merit.  Petitioner fails to cite any legal authority that prohibits CMS from updating or changing its determinations, and I am aware of none.  To the contrary, DAB decisions hold that “CMS may defend a noncompliance determination based on facts, evidence, or reasoning not specified in the Statement of Deficiencies, provided . . . that due process requirements – adequate notice and a meaningful opportunity to be heard – are satisfied.” Golden Living Ctr. – Superior, DAB No. 2768 at 8 n.4 (2017).  Thus, if CMS had changed its theory of the case by relying on different or additional deficiencies beyond those cited in the August statement of deficiencies, this would not be a basis to find the deficiencies invalid. 

However, I find nothing in the record to support Petitioner’s claim that CMS changed its position regarding what deficiencies would be cited or the scope and severity of those deficiencies.  The only statement in the record addressing the noncompliance found at the August survey is in a letter to Petitioner from the state agency, not CMS.  See P. Ex. 2.  As far as the record shows, CMS itself did not address Petitioner’s noncompliance until

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CMS issued the November 4, 2020 notice letter, following the October revisit survey.  CMS Ex. 2.  Petitioner’s argument therefore attempts to bind CMS to the state agency’s initial view of the deficiencies cited.  Such a result would reverse the roles of the state agency and CMS, contrary to the Act and regulations.  See Act, § 1819(h)(1) (state agency recommends action to the Secretary) (emphasis added); 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, DAB No. 2830 at 14 (“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 and whether immediate jeopardy exists).  As these decisions make clear, nothing in the Act or regulations bars CMS from deciding to cite different deficiencies at a different scope and severity than those recommended by the state agency surveyors.¹²  Similarly, other DAB decisions hold that if a given set of facts demonstrates a SNF has violated more than one participation requirement, CMS may, in its discretion, cite the SNF for violating any, or all, of the applicable requirements.  Brian Ctr. Health & Rehab./Goldsboro, DAB No. 2336 at 6 (2010).  Nor can Petitioner plausibly argue that it was unfairly surprised by the noncompliance determination, since CMS’s November 4 notice letter informed Petitioner of CMS’s determinations.  See CMS Ex. 1. 

As I have found that there is ample, undisputed evidence that Petitioner failed to comply substantially with 42 C.F.R. § 483.45(f)(2), I affirm CMS’s determination of noncompliance and grant summary judgment in favor of CMS as to that issue. 

2. Petitioner was not in substantial compliance with 42 C.F.R. § 483.70(i)(1)-(5) (F842) because it failed to ensure resident medical records were complete, accurately documented, readily accessible, and systematically organized. 

42 C.F.R. § 483.70(i)(1) states that, “the facility must maintain medical records on each resident that are complete, accurately documented, readily accessible and systematically organized.  42 C.F.R. § 483.70(i)(5) states that:

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[t]he medical record must contain sufficient information to identify the resident; [a] record of the resident’s assessments; [t]he comprehensive plan of care and services provided; [t]he results of any preadmission screening and resident review evaluations and determinations conducted by the State; [p]hysician’s, nurse’s, and other licensed professional’s progress notes; and [l]aboratory, radiology and other diagnostic services reports as required under § 483.50. 

The undisputed facts establish that Petitioner confused the identities of two residents for two days, causing one resident to be sent to the emergency room under the identity of another resident, while the resident that remained received the hospitalized resident’s medications instead of his own, while staff documented the care it provided in the hospitalized resident’s medical record.  It is therefore apparent that the medical records for D.C. and A.W. were not complete or accurately documented in violation of 42 C.F.R. § 483.70(i)(1).  It is equally clear that the medical records for D.C. and A.W. did not contain sufficient information to identify them, nor accurate records of their assessments and progress notes in violation of 42 C.F.R. § 483.70(i)(5). 

First, Petitioner’s records lacked sufficient information to identify D.C. and A.W.  When the residents were admitted to Petitioner’s SNF, their electronic health records were unavailable.  Even when the electronic records became available, the residents’ photographs were not present.  CMS Ex. 31 at 3.  The absence of photographs contributed to Petitioner’s staff confusing the residents’ identities.  Next, because the residents were misidentified, Petitioner’s staff entered incorrect information in each resident’s medical records.  For example, Petitioner’s staff entered A.W.’s blood pressure readings for August 19, 2020, in D.C.’s medical record.  Id. at 55.  The blood pressure readings in D.C.’s record could not have been obtained from D.C., because the readings were taken at 4 am and later.  Id.  Meanwhile, D.C. had been transferred to the hospital shortly after midnight (staff documented D.C.’s transfer to the hospital in A.W.’s chart, however).  Id. at 128.  In addition, printouts of D.C. and A.W.’s progress notes show that Petitioner’s staff later had to correct each medical record by striking information concerning the other resident.  See id. at 126-27, 129‑37.  Thus, the medical records for each resident were obviously inaccurate, as the observations recorded did not describe the conditions of the named residents.  Moreover, the inaccurate medical records had the potential to cause ‒ and did cause ‒ more than minimal harm to A.W., because he did not receive his prescribed medications, which exacerbated his diabetes and high blood pressure.

These failures were able to occur, at least in part, because staff did not implement Petitioner’s Resident Identifiers policy, which required staff to use at least two identifiers to verify a resident’s identity, prior to providing care.  Id. at 58; see also id. at 1 (when staff gave medications on August 19, the photographs were not yet in the system).

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Further, Petitioner’ s policy instructs that a resident’s room number is not an acceptable means of verifying identity.  Id. at 58.  A facility’s failure to follow its own policies may be evidence of a deficiency.  Good Shepherd Home for the Aged, Inc., DAB No. 2858 at 12 (2018) (a resident care policy may reflect the facility’s own judgment about how best to achieve compliance; thus, failure to comply with its own policies can support a finding that the facility did not achieve compliance with the regulatory standard) (citing Bivins Memorial Nursing Home, DAB No. 2771 at 9 (2017)). 

Petitioner again does not attempt to dispute these facts as to D.C. and A.W.  It instead again argues that CMS should not be allowed to cite violations in a revisit survey that were not cited in the original survey.  P. Br. at 16-17.  For the same reasons explained in the previous section of this decision, I reject this argument. 

In its brief, CMS alleges that Petitioner’s care of a third resident, S.R., also violated 42 C.F.R. § 483.70(i)(1)-(5).  CMS Br. at 4-5, 16.  Petitioner disputes that its care of S.R. was noncompliant.  P. Br. at 11-14.  Petitioner supports its argument with the written direct testimony of Gertrude Massamba, LVN and Amanda Robinson.  P. Exs. 7, 8.  I find that the testimony of Petitioner’s witnesses raises disputes of material fact concerning whether Resident S.R.’s medical records were substantially noncompliant with the regulatory requirements.  However, 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).  Because the facts I have found concerning Petitioner’s care of D.C. and A.W. are more than sufficient to sustain the finding of substantial noncompliance, I do not consider the care of Resident S.R. in concluding that Petitioner was out of substantial compliance with 42 C.F.R. § 483.70(i)(1)-(5). 

4. Petitioner’s arguments concerning its plan of correction concern issues that are not initial determinations under 42 C.F.R. § 498.3.

Petitioner additionally argues that it had corrected any deficiencies prior to the October revisit survey because it had fully implemented the plan of correction (POC) it submitted following the August survey (the September POC).  P. Br. at 19-22.  Petitioner states that CMS “failed to evaluate ‒ or even acknowledge ‒ the September POC.”  Id. at 21.  Whether CMS accepted or rejected Petitioner’s September POC is immaterial to my decision as a matter of law.  As many decisions of the DAB have held, administrative review under 42 C.F.R. Part 498 is limited to the initial determinations listed in section 498.3.  See, e.g., Great Lakes HealthCare, LLC, DAB No. 2777 at 6-7 (2017)(citing cases).  The Great Lakes decision specifically rejected the provider’s argument that it could obtain administrative law judge review of CMS’s alleged failure to formally act on a POC:

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The legal issue is the same regardless of whether CMS acts or fails to act on a proposed POC; neither administrative act is listed as an “initial determination” in section 498.3(b), therefore neither is subject to review by an [administrative law judge] or the Board. 

Id. at 7.  Therefore I need not ‒ indeed I may not ‒ consider or opine on CMS’s actions (or inactions) on Petitioner’s September POC. 

5. CMS’s immediate jeopardy determination is not reviewable. 

Petitioner argues that the finding of immediate jeopardy is clearly erroneous.  P. Br. at 18.  However, I do not consider this argument because the regulations do not permit me to review the finding of immediate jeopardy in this case.  An administrative law judge may review CMS’s scope and severity findings (including a finding of immediate jeopardy) only if:  (1) a successful challenge would affect the range of the CMP; or (2) CMS has made a finding of substandard quality of care that results in the loss of approval of a facility’s Nurse Aide Training and Competency Evaluation Program (NATCEP).¹³  42 C.F.R. § 498.3(b)(14), (d)(10); see also Cedar Lake Nursing Home, DAB No. 2344 at 9 (2010); Evergreen Commons, DAB No. 2175 at 2 (2008), aff’g DAB CR1684 (2007); Aase Haugen Homes, Inc., DAB No. 2013 (2006). 

For PICMPs, the regulations provide for a single penalty range ($2,233 to $22,320), without regard to the level of noncompliance.¹⁴  42 C.F.R. § 488.438(a)(2).  Here, CMS imposed two PICMPs of $14,390 each.  Thus, the finding of immediate jeopardy does not affect the range of the CMP.  See NMS Healthcare of Hagerstown, DAB No. 2603 at 6-7 (2014); see also Oaks of Mid City Nursing & Rehab., DAB No. 2375 at 24.  Similarly,

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CMS’s scope and severity finding does not affect approval of the facility’s NATCEP.¹⁵  Under the statute and regulations, the state agency cannot approve the program if CMS imposes a penalty of $11,160¹⁶ or more; the facility loses its approval without regard to the immediate jeopardy finding, even if that finding constitutes substandard quality of care.  Act § 1819(f)(2)(B) (42 U.S.C. § 1395i‑3(f)(2)(B); 42 C.F.R. § 483.151(b)(2)(iv); see Sunshine Haven Lordsburg, DAB No. 2456 at 3 (2012), aff’d in part, Sunshine Haven Nursing Operations, LLC v. U.S. Dep’t of Health & Human Servs., 742 F.3d 1239 (10th Cir. 2014).  Under the statute and regulations, it is the dollar amount of the CMP, and not the level of noncompliance, that results in the loss of the facility’s NATCEP.  Because the dollar amount of the CMP is above the threshold that triggers loss of NATCEP approval (and I affirm the amount of the CMP below), the absence of substandard quality of care would not restore Petitioner’s NATCEP.  For these reasons, I have no basis to review CMS’s determination that Petitioner’s deficiencies posed immediate jeopardy to its residents.  Furthermore, as I explain below, the amounts of the CMPs imposed are reasonable.

6. The remedies imposed are reasonable.

Regarding the amount of the CMPs, I examine whether a CMP was reasonable by applying 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 § 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.  Unless a facility contends that a particular regulatory factor does not support the CMP amount that CMS proposed, the administrative law judge must sustain it.  Coquina Ctr., DAB No. 1860 (2002) (2002 WL 31985890 at *18).  The regulations specify that a CMP that is imposed against a facility on a per-instance basis 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.  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,

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requiring only that the regulatory factors at §§ 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). 

CMS decided to impose two PICMPs in this case.  Each PICMP that CMS imposed was $14,390, which is near the middle of the range permitted for PICMPs. 

CMS argues primarily that the PICMPs imposed are reasonable because they are near the middle of the permitted penalty range and because of the severity of Petitioner’s noncompliance, which caused actual harm to A.W.  CMS Br. at 18.  Petitioner did not argue against any of the regulatory factors set forth above.  P. Br. at 18-19.  Instead, it argues that CMS has not met its burden of showing that Petitioner was in substantial noncompliance with regard to Resident S.R., and therefore the penalty must be revised downward.  Id. 

I disagree.  Each of the two instances of noncompliance which I have upheld above was significant and caused actual harm to a resident.  The fact that I have not considered whether Petitioner’s care of a third resident is further evidence of substantial noncompliance does not lessen the seriousness of the other instances.  Petitioner’s noncompliance was severe, and Petitioner was highly culpable for that noncompliance.  Each of these factors, whether viewed separately or in tandem, supports the imposition of a PICMP in the middle of the permitted range.  Consequently, I conclude that the two $14,390 PICMPs imposed by CMS are reasonable. 

V.     Conclusion

For the reasons set forth above, I sustain CMS’s determinations.  I conclude that Petitioner was not in substantial compliance with the participation requirements at 42 C.F.R. §§ 483.45(f)(2) and 483.70(i)(1)-(5).  I also conclude that the imposed PICMPs are reasonable.  I therefore grant CMS’s motion for summary judgment and deny Petitioner’s cross-motion for summary judgment.

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Endnotes

¹  Petitioner’s SNF is part of a “continuing care retirement community.”  Petitioner’s Brief (P. Br.) at 2.  Petitioner’s campus offers “a continuum of integrated care” that includes independent living, assisted living, and memory care, which are housed separately from Petitioner’s SNF.  Id. 

²  My conclusions of law appear as headings in bold italic type. 

³  While minimizing the impact of these facts, Petitioner acknowledges the room assignments of two residents admitted to the COVID-19 unit (within its SNF) on August 18, 2020, were changed, which led to the residents’ identities being confused.  P. Br. at 2. 

⁴  Petitioner contends that it was prevented from obtaining potentially relevant evidence because I denied its request for a subpoena duces tecum.  P. Br. at 6; see also DAB E‑File, Docket Entries # 26 and # 27.  Petitioner asked me to compel CMS and the state agency to produce records relating to all surveys of Petitioner’s SNF from January 1, 2018 through January 1, 2021.  Thus, the request included surveys not at issue in the present case.  In addition, Petitioner requested guidance documents from CMS to its regional offices and to facilities nationwide.  As I stated in my order denying Petitioner’s subpoena request, Petitioner appeared to be seeking discovery of documents related to CMS’s or the state agency’s decision-making processes.  Such documents are not relevant to any issue I am authorized to hear and decide.  See Oaks of Mid City Nursing & Rehab. Ctr., DAB No. 2375 at 33 (2011); see also n.12, infra.

⁵  I refer to the residents in this case by their initials, rather than by the numerical identifiers assigned during the survey.  See CMS Ex. 5 at 1.  I do this because, as CMS points out, the numerical identifiers are sometimes interchanged in the documents of record.  See CMS Br. at 2 n.2.  Importantly, Petitioner does not dispute the identity of either resident nor that their identities became confused.

⁶   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 April 19, 2023) (the cited material appears at page 168 of the PDF file).

⁷  I have drawn the timeline of events described in this section primarily from the state agency surveyors’ notes and the statements of deficiencies.  While some of this material includes hearsay statements, CMS (and I) may rely on such statements to establish a prima facie case of noncompliance.  Florence Park Care Ctr., DAB No. 1931 (2004) (2004 WL 1764743 at *6, *17); see also Evergreene Nursing Care Ctr., DAB No. 2069 (2007) (2007 WL 1354307 at *8).  Moreover, Petitioner has failed to produce any witnesses who disavow the statements attributed to them or recount a different version of the events.  As noted above, to defeat summary judgment, Petitioner may not rely on its pleadings or briefs, but must present evidence that raises a material fact.  Senior Rehab., DAB No. 2300 at 3.  I therefore conclude the facts in this section are undisputed.

⁸  It appears Petitioner designated an area within its SNF as a “COVID-19 unit.”  See P. Br. at 2; see also CMS Ex. 6 at 1.

⁹  In light of the Supreme Court’s decision in Azar v. Allina Health Services, 139 S. Ct. 1804 (2019), it is unclear what weight, if any, to give sub-regulatory guidance such as CMS manuals when adjudicating an administrative appeal.  I nevertheless consider the SOM interpretation to be consistent with the plain meaning of the regulation.

¹⁰  In 2016, CMS issued a final rule that re-designated and revised the provisions of 42 C.F.R. Part 483.  See Final Rule, Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities, 81 Fed. Reg. 68,688 (Oct. 4, 2016).  Prior to 2016, the Pharmacy Services regulation was codified at 42 C.F.R. § 483.25(m)(2).  See id. at68,828.  The cited decisions interpreted 42 C.F.R. § 483.25(m)(2).  I find it appropriate to rely on the reasoning of these decisions in the present case because 42 C.F.R. § 483.45(f)(2) (as currently codified) remains essentially identical to 42 C.F.R. § 483.25(m)(2) (as formerly codified).

¹¹  Further, the only reason that Petitioner did not administer A.W.’s medications to D.C. (which I find would have been a significant medication error), is because Petitioner had sent D.C. to the hospital.  Although I do not rely on this fact in finding Petitioner noncompliant with 42 C.F.R. § 483.45(f)(2), there was at least a risk that the hospital would provide D.C. with incorrect medications because the hospital believed him to be A.W. based on the records Petitioner sent to the hospital with D.C. 

¹²  As this analysis demonstrates, any evidence suggesting CMS may have instructed the state agency to cite different deficiencies at a different scope and severity following the October revisit survey that Petitioner sought through its subpoena duces tecum would be immaterial to my decision.  This is so because such evidence, if it existed, would not lead to a different outcome.

¹³  Petitioner’s arguments also fail to acknowledge the regulations’ directive that 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).  Moreover, to the extent Petitioner’s argument is that CMS failed to make a prima facie case that Petitioner’s noncompliance represents immediate jeopardy, this is equally incorrect.  The appellate decision in Liberty Commons Nursing and Rehab Ctr. - Johnston, DAB No. 2031 (2006) (2006 WL 1726482), aff’d Liberty Commons Nursing & Rehab Ctr.-Johnston v. Leavitt, 241 F. App’x 76 (4th Cir. 2007), holds that requiring CMS to make a prima facie case as to the level of noncompliance would conflict with the presumption created by 42 C.F.R. § 498.60(c)(2).  2006 WL 1726482 at *12.

¹⁴  The CMP ranges listed in the regulations are adjusted annually for inflation under 45 C.F.R part 102.  The amounts I cite here were those in effect at the time CMS imposed the remedies at issue in the present case.  85 Fed. Reg. 2869, 2880 (January 17, 2020).

¹⁵  The record does not reveal whether Petitioner maintained a NATCEP during the period in question. 

¹⁶  As is true of the CMP ranges, the CMP dollar amount that triggers disapproval of a NATCEP was adjusted upward for inflation.  85 Fed. Reg. at 2886.