Legend Healthcare and Rehabilitation - Paris, DAB CR5873 (2021)

DECISION

I grant summary judgment in favor of the Centers for Medicare & Medicaid Services (CMS), sustaining its determination that Petitioner, Eiffel Healthcare, Inc. dba Legend Healthcare and Rehabilitation – Paris, a skilled nursing facility, failed to comply with a Medicare participation requirement.  Additionally, I sustain CMS’s determination that Petitioner’s noncompliance was so egregious as to comprise immediate jeopardy for residents of its facility.  Finally, I sustain the imposition of remedies against Petitioner consisting of the following:  civil money penalties (CMP) of $6,500 per day for each day of a period from August 18, 2020 through September 23, 2020; and penalties of $550 for one day of noncompliance, on September 24, 2020. 

I. Background

CMS filed a brief in support of its motion for summary judgment (CMS Br.) plus 10 exhibits that it identified as CMS Ex. 1-CMS Ex. 10.  Petitioner filed a pre-hearing brief in opposition (Petitioner’s brief) and 14 exhibits that it identified as P. Ex. 1-P. Ex. 14.

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It is unnecessary that I rule on the admissibility of the parties’ exhibits inasmuch as I grant summary judgment based on undisputed material facts.  In this decision I cite to some of those exhibits, but only to illustrate facts that are undisputed.

II. Issues, Findings of Fact and Conclusions of Law

A. Issues

The issues are whether Petitioner failed to comply with a Medicare participation requirement, whether Petitioner’s noncompliance was so egregious as to comprise immediate jeopardy for its residents, and whether CMS’s penalty determinations are reasonable in amount and duration.

B. Findings of Fact and Conclusions of Law

I evaluate a motion for summary judgment based on the criteria set out at Rule 56 of the Federal Rules of Civil Procedure.  I am mindful that I must base my decision only on material facts that are undisputed.  I must draw whatever inference may be favorable to the party opposing the motion where more than one inference may reasonably be drawn from the facts.

1. Noncompliance

CMS alleges that Petitioner failed to comply substantially with the participation requirement stated at 42 C.F.R. § 483.25 (Tag F684 - Quality of Care).  In relevant part, this regulation requires a skilled nursing facility to provide care to its residents that complies with professionally recognized standards of practice.

CMS alleges that Petitioner failed to comply with this regulation because, for a period of 24 days, its staff failed to perform any tests to measure the blood sugar levels of a diabetic resident and failed to inquire from relevant health care providers as to why there were no orders for testing to be performed.  It contends that these failures violated Centers for Disease Control (CDC) guidelines and the recommendations of the manufacturers of the medications that were prescribed to the resident to address his diabetes.  CMS argues that the failure created a likelihood that the resident would sustain serious injury, harm or death.  CMS Br. at 4-9. 

I find that the undisputed facts unequivocally support CMS’s allegations.  These facts are as follows.

Resident 1, a 96-year-old individual, was admitted to Petitioner’s facility on August 18, 2020, following discharge from a behavioral hospital.   The resident suffered from a number of medical conditions including a contusion to his left foot, an unspecified open

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wound (left ankle), and Type II diabetes.  CMS Ex. 5 at 1-2.  The resident was identified as being at risk for the development of pressure ulcers.  He had a diabetic foot ulcer.  Id.; CMS Ex. 3 at 1-4.

The resident had been receiving insulin on a sliding scale prior to the hospitalization that predated his admission to Petitioner’s facility.  His blood sugar levels were checked at the hospital on August 10 and 11, 2020.  CMS Ex. 5 at 7-8, 10-17.  However, the discharge document from the hospital did not order that the resident continue to receive insulin.  He left the hospital with prescriptions for three oral medications to address aspects of his diabetes, including Alogliptin Benzoate, Amaryl, and Januvia.  CMS Ex. 3 at 1-4; CMS Ex. 5 at 154-55.1

Guidelines issued by the CDC state that monitoring a diabetic patient’s blood sugar level is critical to managing Type II diabetes.  CMS Ex. 7 at 1-5.  Blood sugar levels should be checked for both low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia).  Hyperglycemia can lead to a condition known as diabetic ketoacidosis (a form of metabolic acidosis), a very dangerous condition that can cause coma or death.  Id. at 3.  Blood sugar levels of above 180 milligrams per deciliter within two hours after eating are abnormally high.  Id. at 2.

The manufacturer’s instructions for administration of Januvia are consistent with CDC guidelines.  The instructions for administration of Januvia provide that their response to all diabetic therapies should be monitored by periodic blood glucose and AIC tests.  P. Ex. 13 at 1.  An “AIC test” is a test that measures a patient’s average blood sugar level over a period of two or three months.  CMS Ex. 7 at 4.  Instructions for administration of Pioglitazone direct that tests should be performed periodically to monitor glycemic control and the therapeutic response to medications.  P. Ex. 13 at 2.

The care instructions from the behavioral hospital did not address discontinuation of the resident’s insulin therapy, nor did they specify that the resident’s blood sugar be checked.  The resident’s treating physician did not order blood sugar checks.  P. Ex. 11 at 1-3.

Nothing in the record shows that Petitioner’s staff queried the hospital about the change in the resident’s diabetes medication.  Nor did it ask the hospital or the resident’s

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physician about their failures to order monitoring of Resident 1’s blood sugar levels.  Petitioner’s director of nursing admitted that during the resident’s stay she did not seek clarification regarding his diabetes management.  CMS Ex. 6 at 4-5.

Petitioner’s staff did not check Resident 1’s blood sugar levels at any time during his 24‑day stay at Petitioner’s facility.  CMS Ex. 5 at 111-51.

Petitioner discharged Resident 1 to an acute care hospital on September 10, 2020.  On admission, the resident manifested gangrene in his left toe and was in septic shock.  The hospital staff measured the resident’s blood sugar level to be 764, more than four times the maximum acceptable blood sugar level as measured within two hours after eating.  The resident’s hospital admission diagnoses included hyperglycemia and severe metabolic acidosis.  CMS Ex. 3 at 1-5; CMS Ex. 5 at 153; CMS Ex. 6 at 1-6.  The resident died on September 17, 2020.  CMS Ex. 6 at 6.

These undisputed facts establish an abject failure by Petitioner to provide professionally acceptable care to Resident 1.  Petitioner’s staff knew or should have known that periodically measuring a diabetic resident’s blood sugar levels was a critical element of providing that resident with skilled nursing care.  The staff was also put on notice by the package instructions that accompanied at least one of the medications that it was providing to Resident 1 (Januvia) that it should measure the resident’s blood sugar levels.  The staff failed to perform even a single test despite being put on notice of the need to do so.  Petitioner’s staff failed to inquire why there were no orders on file that the resident be tested.

It is no defense to argue that the staff was relieved of the responsibility to do testing in the absence of a physician’s order that it do so.  At a minimum, Petitioner’s staff should have queried the hospital that discharged Resident 1 into Petitioner’s care and the resident’s physician about the need to do testing, given that both the CDC and the manufacturers of medication being given to the resident directed that testing be performed.  As Petitioner’s director of nursing admitted, Petitioner’s staff failed to make any inquiry.

The failure to perform any testing during Resident 1’s 24-day stay at Petitioner’s facility defies common sense.  As the CDC makes clear, uncontrolled hyperglycemia can lead to very dangerous, even fatal, ketoacidosis, as it plainly did in the case of Resident 1.  The professional nurses on Petitioner’s staff must have known that basic precept.  However, the staff ignored this fundamental element of care.

Equally confounding is Petitioner’s staff’s failure to ask either the behavioral hospital or the resident’s physician why there were no orders for tests.  Staff knew that tests were required because the medications’ instructions included a requirement for testing. 

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I find Petitioner’s arguments to be unavailing. 

In its defense Petitioner offered the declarations of three individuals.  P. Ex. 11-P. Ex. 13.  These include the declarations of:  Stephen J. Burns, M.D., Resident 1’s treating physician; Gina Rushing, D.O., another physician; and Lee Ann Hampton, PharmD., a local pharmacist.  In his declaration, Dr. Burns admits that he did not order testing of Resident 1’s blood sugar levels.  P. Ex. 11 at 2.  He avers that based on his medical education and clinical experience, it is common for diabetic patients on oral medications to be well-controlled and not require daily blood sugar checks.  Id.

It is unnecessary that I address the validity of Dr. Burns’ opinion, although I note that Dr. Burns does not, his statement that diabetic residents don’t always need tests aside, explain why he failed to order tests for Resident 1.  As I have discussed, Petitioner’s staff had an absolute duty to inquire of Dr. Burns as to why he hadn’t ordered blood sugar testing, given the CDC guidelines and the medication manufacturers’ instructions.  As Dr. Burns acknowledges, he provided no guidance to Petitioner’s staff about blood sugar testing.  There is no record that he and the staff discussed that question at all, and Petitioner’s director of nursing admitted that she did not make or direct any inquiry. 

Moreover, Dr. Burns’ opinion is a red herring.  Whether or not daily blood sugar testing was necessary in this case is not at issue.  At issue is the failure by Petitioner’s staff to perform blood sugar testing on Resident 1 at any time during his 24-day stay at the facility.  That failure blatantly violates the professional practice standards established by the CDC and the medication manufacturers’ directions.

From the face of her declaration, Dr. Rushing had no care relationship with Resident 1.  P. Ex. 12.  She does not aver that she reviewed the resident’s treatment records, nor does she acknowledge any understanding of CDC guidelines or the medication manufacturers’ instructions.  Id.  She declares, without any foundation whatsoever, that “Residents on oral hyperglycemia medication do not necessarily need routine blood sugar checks.”  Id.

It is not necessary that I address the validity of Dr. Rushing’s opinion – even though it plainly contradicts established guidelines – in order to conclude that it is of no benefit to Petitioner.  My decision in this case is grounded on the admitted failure of Petitioner’s staff to inquire about the absence of any directions concerning blood sugar testing of Resident 1.  That failure to consult would comprise noncompliance even if a consultation with a physician might have resulted in a conclusion that tests were unnecessary.

In her declaration, Ms. Hampton avers that neither Januvia nor Pioglitazone lead to “hypoglycemia significant enough to warrant routine daily finger sticks.”  P. Ex. 13 at 1.  That opinion is another red herring because the issue here is whether failure to test Resident 1’s blood sugar resulted in undisclosed hyperglycemia – dangerously high levels of blood sugar – a condition that both the CDC and the medications’ manufacturers warn

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about.  However, Ms. Hampton admits that the package insert instructions for both medications, Januvia and Pioglitazone, call for periodic monitoring of blood sugar levels, something that Petitioner did not do.  Id. at 1-2.

Ms. Hampton avers that she would recommend following the prescriber’s recommendation on the routine ordering of tests.  P. Ex. 13 at 2.  This opinion is of no benefit to Petitioner because, as the undisputed facts show, the record of Resident 1’s care is devoid of any recommendation from a prescriber, and Petitioner’s staff made no effort to obtain one.

Petitioner’s additional arguments are unavailing as well.  Petitioner asserts that its staff relied on the absence of orders to perform blood sugar level testing, either from the behavioral hospital or from Resident 1’s physician.  It contends that the absence of orders absolved it from responsibility.  Petitioner’s brief at 7-9.  Further, it contends that there was no requirement that its staff perform mandatory blood sugar checks.  Id.

However, in this case, Petitioner’s staff plainly knew or should have known that some amount of blood sugar testing – whether it be daily or at some other regular interval – was necessary to protect the Resident 1 against the development of ketoacidosis.  CDC guidelines explicitly require that testing.  Petitioner’s assertions notwithstanding, the medication manufacturers’ instructions plainly call for testing.  Given that, Petitioner’s staff could not sit back and do nothing – which is exactly what it did – without querying the resident’s physician about whether and when testing should be performed.

Next, Petitioner contends that there are statements in the report of the survey of Petitioner’s facility that are erroneous or that misinterpret the facts.  Petitioner’s brief at 9-10.  The only statement that Petitioner identifies is a statement attributed to Dr. Burns in which he is reported to have declared that he would order blood sugar monitoring of all residents of the facility who were not receiving hospice or palliative care.  Id. at 9; see CMS Ex. 3 at 6. 

There is a dispute of fact as to what the surveyors reported Dr. Burns as having said and what he subsequently asserts that he said to the surveyors.  See P. Ex. 11 at 2.  I do not find this fact dispute to be material to my decision.  Whether or not Dr. Burns would have ordered that Resident 1’s blood sugar levels be tested if Petitioner’s staff had inquired about testing is immaterial, because the staff made no such inquiry.

Petitioner argues at length that its staff provided care to Resident 1 that is consistent with professionally recognized practice standards and that there can be no finding of noncompliance given that its staff complied with applicable standards.  Petitioner’s brief at 10-15.  As support for these assertions, Petitioner provides a detailed statement of the care that it provided to the resident and its communications with the resident’s family about that care.  Id. at 10-11.  However, all of this described care – even if it was

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appropriate – begs the question of Petitioner’s compliance.  At issue here is the care that Petitioner failed to provide.

2. Immediate Jeopardy

Immediate jeopardy level noncompliance is noncompliance that is so egregious that it causes or is likely to cause a resident or residents to suffer serious injury, impairment, harm, or death.  42 C.F.R. § 488.301.  If I were to hold an evidentiary hearing in this case, it would be Petitioner’s burden to prove that CMS’s determination of immediate jeopardy level noncompliance is clearly erroneous.

Petitioner’s burden is different in defending against a motion for summary judgment.  Petitioner must adduce facts that call into dispute a finding of immediate jeopardy.  I must deny summary judgment on the issue of immediate jeopardy if there are facts from which I could infer that the jeopardy finding is clearly erroneous.

The undisputed facts establish that, if Petitioner’s staff’s failure to test Resident 1’s blood sugar levels did not result in his death, the failure certainly created the likelihood that he would experience a life-threatening condition.  The facts establish that, after 24 days without his blood sugar levels being tested even once, Resident 1’s blood sugar was elevated to 764 mg/dl (more than four times the acceptable maximum non-fasting blood sugar level), the resident was suffering from severe ketoacidosis (metabolic acidosis), and he died a few days thereafter.  The inescapable conclusion from these facts is that failure to test Resident 1’s blood sugar produced a concomitant failure to diagnose life-threatening hyperglycemia and its consequences.

Petitioner offers no facts that challenge CMS’s immediate jeopardy determination.  Essentially, its argument is that it complied with regulatory requirements in providing care to Resident 1.  It asserts that there can be no immediate jeopardy if it complied with regulatory requirements.  However, the undisputed facts plainly establish noncompliance, and those facts also lead only to a conclusion that the noncompliance in this case jeopardized Resident 1’s life.

3. Remedies

CMS determined to impose civil money penalties against Petitioner consisting of daily penalties in the following amounts and duration:  penalties of $6,500 per day for each day of a period from August 18, 2020 through September 23, 2020; and penalties of $550 for one day of noncompliance, on September 24, 2020. 

The penalty amounts fall both below and within the ranges authorized by regulation for daily civil money penalties.  42 C.F.R. §§ 488.438 (a)(1)(i), (ii);  45 C.F.R. § 102.3.  Indeed, these penalties are quite modest, with the $6,500 per-day immediate jeopardy

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CMP falling below the lowest end of the permissible range for per-day penalties, while the $550 non-immediate jeopardy CMP is at the lowest end of the permissible range for per-day penalties.2

Petitioner has not challenged the amounts or duration of the penalties that CMS determined to impose except to argue that immediate jeopardy level penalties should not be imposed in the absence of immediate jeopardy level noncompliance.  Petitioner’s brief at 15.  However, I have evaluated the reasonableness of the penalty amounts based on the undisputed material facts and applicable regulatory standards for determining penalty amounts.  I find them to be reasonable.

Regulatory criteria for deciding penalty amounts are at 42 C.F.R. §§ 488.438(f)(1)-(4); 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)).  These criteria include the seriousness of noncompliance, a facility’s culpability for its noncompliance, and its financial condition.

I find Petitioner’s noncompliance to have been extremely serious.  As I have discussed, Petitioner’s staff’s failure to inquire about whether to test Resident 1’s blood sugar and its total failure to perform any tests for a period of 24 days clearly put the resident’s life at jeopardy, even if these failures did not directly cause the resident to die.  Moreover, Petitioner is culpable for its noncompliance.  The staff knew or should have known that professional practice standards required that the resident’s blood sugar levels be tested at least periodically.  The failure by the staff to at least inquire about the absence of orders to perform tests constitutes an abject failure by the staff to perform its responsibilities.

Petitioner did not offer any facts to show that its financial condition precludes it from paying the penalties that CMS determined to impose.  Consequently, I find that Petitioner is under no financial constraint that would prevent it from paying these penalties.

1. A pharmacist’s declaration proffered by Petitioner discusses an additional medication, Pioglitazone.  The declaration  suggests that this drug was provided to Resident 1.  I take notice that Pioglitazone is sometimes administered in combination with Alogliptin Benzoate.  Resident 1’s clinical records do not state expressly that he received this medication.  Compare P. Ex. 13, CMS Ex. 5 at 5 with CMS Ex. 3 at 3, CMS Ex. 5 at 154-55, P. Ex. 11 at 1.  However, if Resident 1 did receive Pioglitazone, as the pharmacist admits, manufacturer instructions call for periodic testing for both Pioglitazone and for Januvia.  It is undisputed that Resident 1 was given Januvia.
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2. The range for per-day immediate jeopardy deficiencies in 2020 is $6,808 to $22,320, while the lower range for deficiencies that are not immediate jeopardy is $112 to $6,695.  45 C.F.R. § 102.3 (as of January 17, 2020).  Since the reasonableness of the CMP amount, rather than the amount itself, is at issue, I need not address why CMS selected a per-day CMP amount for an immediate jeopardy deficiency that is less than authorized.
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