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                              The Heights of Tomball, DAB CR6147 (2022)
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The Heights of Tomball, DAB CR6147 (2022)








  
  
    

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





The Heights of Tomball
(CCN: 676350),
Petitioner,

v.

Centers for Medicare & Medicaid Services.
Docket No. C-17-482Decision No. CR6147August 25, 2022

        
              
    

      DECISION

I reverse the Centers for Medicare & Medicaid Services' (CMS) determination that Petitioner, The Heights of Tomball, was not in substantial compliance with Medicare participation requirements arising from a complaint investigation completed by the Texas Department of Aging and Disability Services (state agency) on January 4, 2017.  For the reasons discussed below, I conclude that the preponderance of evidence establishes that Petitioner was in substantial compliance with Medicare participation requirements at this time.  Therefore, CMS is not authorized to impose remedies based on the January 4, 2017 complaint investigation.  Additionally, I incorporate into this decision my ruling dated July 9, 2021, in which I granted partial summary disposition in favor of CMS.  In that ruling, I determined that Petitioner was not in substantial compliance with Medicare participation requirements arising from surveys completed by the state agency on October 27, 2016, but deferred ruling on whether the imposed remedies for those deficiencies were reasonable until after a hearing, which I determined was required.  Accordingly, I conclude that CMS has a basis to impose remedies only for the deficiencies found at the October 2016 surveys, and a per-day civil money penalty (CMP) of $1,203, beginning November 6, 2016 through November 10, 2016, is a reasonable remedy.

Page 2

I.  Background and Procedural History

Petitioner is a skilled nursing facility (SNF) located in Tomball, Texas, that participates in Medicare.  On October 27, 2016, surveyors from the state agency completed a complaint investigation and an annual survey, consisting of a standard long-term care health survey; standard life safety code (LSC) survey; and licensing inspection, at Petitioner's facility.  CMS Exhibit (Ex.) 11 at 1; Petitioner Exhibit (P. Ex.) 1 at 1.  As a result of the October 2016 surveys, CMS determined that Petitioner was not in substantial compliance with several Medicare participation requirements1 and imposed the following remedies:  (1) termination of Petitioner's Medicare and Medicaid provider agreement if Petitioner did not achieve substantial compliance before April 27, 2017; and (2) a denial of payment for new admissions (DPNA), beginning November 25, 2016, until the day before Petitioner achieved substantial compliance or was terminated from participation in the Medicare program.  CMS Ex. 1 at 1-2.

The state agency conducted a revisit survey by desk review on December 2, 2016, and found that Petitioner corrected all LSC deficiencies2 cited at the October 2016 survey on November 11, 2016.  P. Ex. 2 at 2; P. Ex. 103 at 5-6.  On January 12, 2017, the state agency conducted a second revisit survey by desk review and found that Petitioner also corrected all health deficiencies cited at the October 2016 survey on November 11, 2016.  P. Ex. 2 at 1; P. Ex. 10 at 3-4.

On January 4, 2017, the state agency completed a new complaint investigation survey concerning Resident #1, an 84-year-old diabetic resident who was hospitalized on December 20, 2016, for acute renal failure, hypernatremia, and hyperglycemic hyperosmolar nonketotic coma (HHNC) with an altered mental status and elevated blood glucose levels, ranging from 500 to 871 mg/dl.  CMS Ex. 2 at 2-3, 6; CMS Ex. 6 at 104-05, 112, 115-19, 123.  The state agency found that Petitioner was not in substantial compliance with Medicare participation requirements related to 42 C.F.R. §§ 483.24 (Quality of life); 483.25(k) (Quality of care:  Pain management); and 483.25(*l*) (Quality

Page 3

of care:  Dialysis).  The state agency cited the noncompliance collectively under Tag F-309 at scope and severity level "G."  CMS Ex. 2 at 1.4  As a result of the January 4, 2017 complaint investigation, the state agency recommended continuation of the previous enforcement remedies, a $1,950 per-instance CMP, and termination if Petitioner were not in substantial compliance by April 27, 2017.  P. Ex. 3 at 1-2; P. Ex. 7.

On January 19, 2017, CMS notified Petitioner that it concurred with the state agency's finding that it was not in compliance with federal participation requirements.  CMS Ex. 1 at 5-9.  In addition to continuation of the DPNA and proposed termination if Petitioner did not establish compliance by April 27, 2017, CMS added a $1,950 per-instance CMP for the deficiency found at the January 2017 survey.  CMS Ex. 1 at 5-6.  On January 23, 2017, CMS notified Petitioner of revised remedies.  *Id.* at 12-18.  CMS rescinded the $1,950 per-instance CMP and imposed a $1,203 per-day CMP for 37 days, beginning November 6, 2016 through December 12, 2016, which totaled $44,511.  *Id.* at 12.  CMS also imposed a $303 per-day CMP, beginning December 13, 2016, until Petitioner achieved substantial compliance.  *Id*.  The previous remedies of the DPNA, beginning November 25, 2016, and proposed termination, on April 27, 2017, remained in effect until Petitioner achieved substantial compliance or termination.  *Id.* at 12-13.

On February 28, 2017, CMS notified Petitioner that its facility achieved substantial compliance, effective January 27, 2017.  *Id.* at 19-21.  CMS rescinded the proposed termination and ended the DPNA and $303 per-day CMP on January 26, 2017.  Thus, CMS' final enforcement remedies imposed against Petitioner for the October 2016 surveys and the January 2017 complaint investigation survey included the following:

A DPNA for 63 days, beginning November 25, 2016, through January 26, 2017;
	A $1,203 per-day CMP for 37 days, beginning November 6, 2016, through December 12, 2016, which totaled $44,511; and
	A $303 per-day CMP for 45 days, beginning December 13, 2016, through January 26, 2017, which totaled $13,635.*Id.* at 19.

On March 24, 2017, Petitioner timely requested a hearing to appeal CMS' noncompliance findings and imposition of the DPNA and CMPs.  P. Request for Hearing (RFH) at 2-3.  The case was docketed and assigned to ALJ Carolyn Cozad Hughes and subsequently

Page 4

reassigned to me.  Departmental Appeals Board (DAB or Board) Electronic Filing System (E-File) Docket Entry Nos. 2, 2a-2b, 14.  The parties filed prehearing exchanges, including prehearing briefs, witness lists and written direct testimony, proposed exhibits, cross-motions for summary judgment, and responses opposing the other party's motion for summary judgment.  DAB E-File Docket Entry Nos. 4, 4a-4j, 5, 5a-5i, 6, 6a-6h, 7, 8-8a, 9-12, 12a-12g, 13, 15, and 17.  I admitted CMS' exhibits into the record, including the declaration of CMS' sole witness, Captain (Ret.) Daniel J. McElroy, R.N., a CMS Nurse Consultant.  *The Heights of Tomball*, ALJ Ruling No. 2021-6 at 9-10 (July 9, 2021); CMS Ex. 29.  I also admitted Petitioner's exhibits into the record, including the affidavits of Petitioner's three witnesses:  Cindy Gabel, Vice President of Revenue Management for Trident Health Services, who is responsible for the oversight of billing all nursing home charges at Petitioner;5 Dezarei Richey, RN-GNPBC, a geriatric nurse practitioner; and Amy Williams, Petitioner's Administrator.  ALJ Ruling No. 2021-6 at 8-10; P. Exs. 4, 5, 8.

On April 20, 2021, I ordered the parties to state whether they wished to cross-examine the other party's witnesses at a hearing or, in the alternative, wished to waive an oral hearing and have the case decided on the written record.  DAB E-File Docket Entry No. 20.  On May 4, 2021, the parties responded that they wished to cross-examine witnesses and did not wish to waive an oral hearing.  DAB E-File Docket Entry No. 21.

On July 9, 2021, I issued a ruling on the parties' cross-motions for summary judgment.  I granted CMS' summary judgment motion, in part, and denied Petitioner's summary judgment motion in its entirety.  ALJ Ruling No. 2021-6 at 2, 32-33.  I concluded that the undisputed facts established that Petitioner was not in substantial compliance with Medicare participation requirements based on the October 2016 surveys.  *Id.* at 2, 11-12, 15-32.  I also determined that a hearing was required to resolve whether Petitioner was in substantial compliance based on the January 2017 complaint investigation and whether the enforcement remedies imposed by CMS are reasonable.  *Id.* at 2, 12-15, 32.  In particular, a hearing was necessary to determine whether:

Petitioner was in substantial compliance at the time of the January 4, 2017 complaint investigation, and consequently, when the facility ultimately achieved substantial compliance after the October 2016 surveys;
	CMS had a basis to continue remedies imposed due to the deficiencies cited during the October 2016 surveys;Page 5

CMS had a basis to impose new remedies due to the alleged deficiency cited during the January 2017 complaint investigation; and
	All of CMS' imposed remedies are reasonable.DAB E-File Docket Entry No. 28 (Notice of Hearing at 1-2).

On July 23, 2021, I convened the hearing via video teleconference.  A transcript (Tr.). was made of the proceeding.  Petitioner cross-examined CMS' witness Capt. McElroy and CMS cross-examined Petitioner's witnesses, Ms. Richey and Ms. Williams.  Tr. at 6-9, 11-50, 67-75.  Both parties also conducted redirect examinations of their respective witnesses.  Tr. at 9-11, 50-66, 75-78.  The parties filed post-hearing briefs (CMS Post-hearing Br., P. Post-hearing Br.) and reply briefs (CMS Post-hearing Reply, P. Post-hearing Reply).  DAB E-File Docket Entry Nos. 33-34, 37, 38.  CMS filed proposed corrections to transcript errata, to which Petitioner did not object.  DAB E-File Docket Entry Nos. 35, 37a.  Petitioner did not file any proposed transcript corrections, but it filed a Motion for Leave to File Late Exhibits.  DAB E-File Docket Entry Nos. 32, 32a.  CMS did not oppose Petitioner's motion.  DAB E-File Docket Entry No. 39.  The administrative record is closed, and the case is fully briefed.  Accordingly, this case is ready for a decision.

II.  Admission of Exhibits and Transcript Corrections into the Record

I previously admitted Petitioner Exhibits 1 through 9 and CMS Exhibits 1 through 29 into the record.  ALJ Ruling No. 2021-6 at 9-10.  On October 20, 2021, Petitioner filed a Motion for Leave to File Late Exhibits (P. Ex. 10 Motion).  Petitioner requested admission of Petitioner Exhibit 10, which "reflect[s] the October 2016 health and Life Safety Code deficiencies were cleared by desk review, without onsite revisits."  P. Ex. 10 Motion at 1.  According to Petitioner:

The proposed exhibit was not offered previously because the issue of whether the tags were cleared by desk review was not in issue until the court ruled in the Order Granting Partial Summary Judgement that the tags were cleared during onsite revisits. The proposed exhibit is offered to reflect the accurate procedural history and to show that no onsite verification of correction was required.

*Id.*  As noted above, CMS did not oppose the motion.  DAB E-File Docket Entry No. 39.

I find that good cause exists to admit Petitioner Exhibit 10 into the record.  Petitioner Exhibit 10 is relevant and material to the issues in this case.  42 C.F.R. §§ 498.60(b)(1),

Page 6

498.61.  Moreover, inclusion of Petitioner's Exhibit 10 ensures a complete and accurate record of this proceeding.  42 C.F.R. §§ 498.64, 498.74(a).  Accordingly, Petitioner's Exhibit 10 is admitted into the administrative record.

Likewise, inclusion of corrections to transcript errata ensures a complete and accurate record of the hearing in this proceeding.  For that reason, I also accept CMS' proposed transcript corrections.  42 C.F.R. § 498.64.  The Notice of Transcript Corrections, dated May 18, 2022, includes CMS' proposed corrections, as well as my additional transcript corrections.  DAB E-File Docket Entry No. 40.

III.  Issues

In my July 9, 2021 ruling, I determined that Petitioner was not in substantial compliance with Medicare participation requirements at 42 C.F.R. §§ 483.10(b)(11), 483.25(c), 483.25, 483.25(d), 483.60(b), (d), (e), 483.75(*l*)(1), and 483.70(a) based on the findings of the October 2016 surveys and complaint investigation.  ALJ Ruling No. 2021-6 at 32-33.  The remaining issues I must decide in this appeal are:

**A.** Whether Petitioner substantially complied with Medicare participation requirements at 42 C.F.R. §§ 483.24 and 483.25(k) and (*l*) based on the findings of the January 2017 complaint investigation; and

**B.** If Petitioner was not in substantial compliance, whether the imposed DPNA for 63 days, a $1,203 per-day CMP for 37 days totaling $44,511, and a $303 per-day CMP for 45 days totaling $13,635 are reasonable.

IV.  Applicable Statutes and Regulations

Sections 1819 and 1919 of the Social Security Act (Act) and their implementing regulations at 42 C.F.R. Part 483 govern a long-term care facility's participation in Medicare and Medicaid.  42 U.S.C. §§ 1395i-3 (pertaining to SNFs), 1396r (pertaining to nursing facilities or NFs); *see* 42 C.F.R. pt. 483.  Petitioner, a SNF, must maintain substantial compliance with program participation requirements.  *See* 42 U.S.C. §§ 1395i-3(b)-(d).  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 the Act or the regulations at 42 C.F.R. Part 483, Subpart B.  42 C.F.R. § 488.301.  "Noncompliance" is "any deficiency that causes a facility to not be in substantial compliance."  42 C.F.R. § 488.301.
The Act also authorizes the Secretary of the United States Department of Health and Human Services (Secretary) to impose enforcement remedies against SNFs that are not in substantial compliance with program participation requirements.  42 U.S.C. § 1395i-3(h)(2).  The Secretary has delegated this enforcement authority to CMS and state

Page 7

agencies.  Among other enforcement remedies, CMS may impose a DPNA and a per-day CMP for noncompliance, regardless of whether the deficiencies constitute an immediate jeopardy level of noncompliance.  42 C.F.R. §§ 488.406, 488.430(a).  CMS also may impose a per-day CMP for the number of days of past noncompliance since the last standard survey, including for days at the immediate jeopardy level.  42 C.F.R. § 488.430(b).  At the time of the January 2017 survey at issue, the upper range for a per-day CMP for noncompliance at the immediate jeopardy level was $6,291 - $20,628, while the lower range for a per-day CMP for noncompliance that did not constitute immediate jeopardy was $103 - $6,188.  42 C.F.R. § 488.438(a)(1); 45 C.F.R. § 102.3; *see also* 81 Fed. Reg. 61,538, 61,565 & 61,574 (Sept. 6, 2016) (providing the annual adjusted CMP amounts for CMPs, effective for the time frame from September 6, 2016, until February 3, 2017).  All enforcement remedies, including a DPNA and a per-day CMP, continue until the facility achieves substantial compliance or its provider agreement is terminated.  42 C.F.R. § 488.454(a)(1)-(2).

If CMS (or a state agency) imposes an enforcement remedy, such as the DPNA or CMPs imposed in this case, a SNF has the right to appeal the noncompliance finding and the enforcement remedy before an ALJ.  42 U.S.C. §§ 1320a-7a(c)(2), 1395i-3(h)(2)(B)(i), (ii); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).  The facility may challenge the scope and severity level of the noncompliance only if a successful challenge would affect the range of CMP amounts that CMS could collect or if 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.  42 C.F.R. § 498.3(b)(14), (d)(10)(i).  However, the facility may not challenge CMS' choice of remedies or the factors CMS considered when choosing remedies.  42 C.F.R. § 488.408(g)(2).  The hearing before an ALJ is a *de novo* proceeding.  *See, e.g., CarePlex of Silver Spring*, DAB No. 1683 (1999) (holding that ALJs hold *de novo* hearings based on issues permitted under the regulations and ALJ review is not a quasi-appellate review).

When an enforcement remedy is imposed and appealed, CMS has the burden to produce evidence sufficient to make a *prima facie* case that Petitioner is not in substantial compliance with Medicare participation requirements and has a basis to impose an enforcement remedy.  *See, e.g.*, *Evergreene Nursing Care Ctr.*, DAB No. 2069 at 7 (2007).  If CMS makes this *prima facie* showing, then Petitioner bears the ultimate burden of persuasion as to whether it substantially complied with the participation requirements.  Petitioner has both the burden of coming forward and the burden of persuasion as to any affirmative defense or rebuttal evidence.  To prevail, Petitioner must show by a preponderance of the evidence on the record, as a whole, that it was in substantial compliance with Medicare participation requirements.  *Id.* at 7-8; *see also Batavia Nursing & Convalescent Inn*, DAB No. 1911 (2004); *Batavia Nursing & Convalescent Ctr.*, DAB No. 1904 (2004), *aff'd*, *Batavia Nursing & Convalescent Ctr. v.*

Page 8

*Thompson*, 129 F. App'x 181 (6th Cir. 2005).

V.  Findings of Fact, Conclusions of Law, and Analysis

I have carefully considered all the evidence, including the exhibits and the testimony at hearing and the arguments of both parties.  My findings of fact and conclusions of law are set forth in bold font followed by detailed factual and legal analyses.

**A. I incorporate my ruling dated July 9, 2021 (*The Heights of Tomball*, ALJ Ruling No. 2021-6) into this decision.**

I incorporate into this decision my ruling of July 9, 2021, granting in part CMS' motion for summary disposition.  In that ruling, I upheld CMS' determination that Petitioner was not in substantial compliance with Medicare participation requirements based on the October 2016 surveys.  Accordingly, CMS has a basis to impose remedies against Petitioner for these deficiencies.

**B. Petitioner was in substantial compliance with Medicare participation requirements at 42 C.F.R. §§ 483.24, 483.25(k), and 483.25(*l*) based on the findings of the January 2017 complaint survey.**

****CMS presented a *prima facie* case alleging that Petitioner was not in substantial compliance with Medicare participation requirements.****CMS has the initial burden to produce evidence sufficient to make a *prima facie* case that Petitioner was not in substantial compliance with Medicare participation requirements based on the January 2017 complaint survey.  *See, e.g., Evergreene*, DAB No. 2069 at 7.  In order to establish a *prima facie* case, CMS must present evidence that is "[s]ufficient to establish a fact or raise a presumption unless disproved or rebutted; based on what seems to be true on first examination, even though it may later be proved to be untrue."  ("*Prima facie*" as defined in *Black's Law Dictionary* (11th ed. 2019), as found on Westlaw; *see also id.* defining *"prima facie case*" as: "1. The establishment of a legally required rebuttable presumption.  2. A party's production of enough evidence to allow the fact-trier to infer the fact at issue and rule in the party's favor.").  The Board has explained that:

Page 9

HCFA6 must identify the legal criteria to which it seeks to hold a provider.  Moreover, to the extent that a provider challenges HCFA's findings, HCFA must come forward with evidence of the basis for its determination, including the factual findings on which HCFA is relying and, if HCFA has determined that a condition of participation was not met, HCFA's evaluation that the deficiencies found meet the regulatory standard for a condition-level deficiency.

*Hillman Rehab. Ctr.*, DAB No. 1611 (1997), 1997 WL 123708 at 6 (1997), *aff'd, Hillman Rehab. Ctr. v. U.S. Dep't of Health & Human Servs.*, No. 98-3789 (GEB), slip op. (D.N.J. May 13, 1999), 1999 WL 34813783 (1999).

I conclude that CMS has met its burden of establishing a *prima facie* case.  Specifically, CMS presented evidence identifying the legal criteria, factual findings, and its determination that Petitioner violated Medicare program participation requirements.  CMS submitted the Statement of Deficiencies and Plan of Correction (Form CMS-2567) identifying the alleged regulatory violations, Petitioner's policies and procedures, and the alleged factual findings supporting the alleged violations.  CMS Ex. 2; *see also* CMS Ex. 8.  CMS also submitted the CMS determination letters (CMS Ex. 1), the surveyor's notes (CMS Ex. 10), Resident #1's medical records (CMS Ex. 6), and the direct and redirect testimony of Capt. McElroy (CMS Ex. 29; Tr. at 50-66), among other documents (CMS Exs. 3-5, 7, 9).

These documents reveal that the January 2017 complaint survey concerned allegations involving Resident #1, an 84-year-old diabetic resident who was hospitalized on December 10, 2016, for acute renal failure, hypernatremia, and HHNC, with an altered mental status and elevated blood glucose levels, ranging from 500 to 871 mg/dl.  CMS Ex. 2 at 3, 6; CMS Ex. 6 at 104-05, 112, 115-19, 123.  According to CMS, Petitioner failed to provide care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being in accordance with Resident #1's comprehensive assessment and plan of care, in violation of 42 C.F.R. § 483.24.  CMS Ex. 2 at 1-2; CMS Ex. 29 at 4-7.  Petitioner also allegedly violated 42 C.F.R. §§ 483.25, 483.25(k), and 483.25(*l*) when it failed to transcribe and implement the entire physician's orders.  CMS Ex. 2 at 1-2; CMS Ex. 6 at 92, 94; CMS Ex. 29 at 4-5.  Furthermore, CMS alleged that Petitioner did not follow its medication administration and physician order process policies with respect to Resident #1.  CMS Ex. 2 at 8, 9; CMS Ex. 8 at 1-2, 9.

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Despite an October 14, 2016 physician's order to check her blood sugar level every morning after a diabetes medication change, CMS alleges that Petitioner did not follow this order and continued to check Resident #1's blood sugar level every seven days.  CMS Ex. 2 at 4-5; CMS Ex. 6 at 1, 12, 68, 94, 96.  On November 21, 2016, Resident #1 had another change in her diabetes medication and blood sugar checks were ordered again for every morning.  CMS Ex. 2 at 5; CMS Ex. 6 at 73, 92, 106.  However, a physician's order sheet was not completed, and Petitioner continued checking Resident #1's blood sugar every seven days.  CMS Ex. 2 at 5; CMS Ex. 6 at 1, 68.  CMS alleges, moreover, that even if the orders for daily checks were properly changed back to weekly blood sugar checks, Petitioner did not carry out the orders for weekly blood sugar checks either.  CMS Post-hearing Br. at 4-6.  For example, CMS argues that no blood sugar checks were recorded "for a period of 23 days straight during October" and "for a full two weeks in the month of November."  CMS Post-hearing Br. at 5, 6 (citing CMS Ex. 6 at 12, 68).

Resident #1's medical record also notes that, on November 29, 2016, her son reported that he or his sister had seen a regular Coke in her room several times and requested it to stop.  CMS Ex. 2 at 5-6; CMS Ex. 6 at 90, 106.  CMS alleges that "there is no indication that the facility evaluated whether [Resident #1] was receiving an appropriate drink or took steps to evaluate how Coke might affect [Resident #1's] blood sugar."  CMS Prehearing Br. at 1; *see also id.* at 8.

CMS also alleges that Resident #1 had a change in condition on December 10, 2016, when she had an altered mental status, her blood sugar level measured 500 mg/dl, and she required hospitalization for acute renal failure, hypernatremia, and HHNC.  CMS Ex. 2 at 2-3, 6; CMS Ex. 6 at 1, 104-05, 115-19.  After she arrived at the hospital's emergency room, Resident #1's blood glucose level was 871 mg/dl.  CMS Ex. 2 at 6; CMS Ex. 6 at 118.  According to CMS, "[i]n the weeks prior to her hospitalization, [Resident #1's] blood sugar levels were often above 200, but the facility did not notify her physician or nurse practitioner, nor did it take steps to address the high sugar levels."  CMS Post-hearing Br. at 1; *see also* CMS Ex. 6 at 1, 12, 68.

Capt. McElroy testified that these events show Petitioner's poor quality communication beginning October 14, 2016, failure to document any baseline finger-stick blood glucose (FSBG) test results before changing Resident #1's diabetes medication, failure to implement blood sugar checks every morning as ordered by the Nurse Practitioner, failure to report high blood sugars to the physician or Nurse Practitioner, failure to document communication between Petitioner's staff and the Nurse Practitioner, and failure to control Resident #1's sugar intake.  CMS Ex. 29 at 4-6; *see also* Tr. at 50-51, 54-55, 58-59, 61.  He also testified that normal serum (venous blood) glucose is 70 to 110 mg/dl, and FSBGs are not to be used on unstable patients.  CMS Ex. 29 at 5.  Capt. McElroy opined

Page 11

that "Resident #1's outcome from [Petitioner's] failures was immediate jeopardy" and her care plan was deficient for not specifying Resident #1's acceptable FSBG parameters and hyperglycemia symptoms for Petitioner's staff to monitor.  CMS Ex. 29 at 6; Tr. at 52-53, 57-59.  According to CMS, Petitioner's failures affected Resident #1 and placed its other 28 diabetic residents at risk for delayed treatment, hospitalization, diabetic coma, and death.  CMS Ex. 2 at 3; CMS Ex. 7.

Based on these alleged facts, the state agency and CMS cited Petitioner for deficiencies related to 42 C.F.R. §§ 483.24, 483.25(k), and 483.25(*l*),7 under Tag F-309, at scope and severity level "G."8  CMS Ex.1 at 5-9.  CMS imposed the continuation of the enforcement remedies from the October 2016 surveys (termination if Petitioner was not in substantial compliance by April 27, 2017, and a DPNA beginning November 25, 2016, until substantial compliance was achieved or termination), and a $1,950 per-instance CMP.  *Id*. at 5-11.  CMS determined that Petitioner returned to substantial compliance on January 27, 2017, rescinded termination, and imposed revised remedies of a DPNA for 63 days (beginning November 25, 2016 through January 26, 2017), a $1,203 per-day CMP for 37 days (beginning November 6, 2016 through December 12, 2016) totaling $44,511, and a $303 per-day CMP for 45 days (beginning December 13, 2016 through January 26, 2017) totaling $13,635.  *Id*. at 19-21.  Capt. McElroy provided testimony explaining the basis for the imposed remedies.  CMS Ex. 29 at 2-3, 7; Tr. at 61-66.

I conclude that the foregoing evidence is sufficient to establish a *prima facie* case that Petitioner violated the Medicare participation requirements at 42 C.F.R. § 483.24 and 42 C.F.R. § 483.25, and CMS had a basis to impose enforcement remedies.  CMS identified the relevant participation requirements and the factual allegations for its determination that Petitioner was not in substantial compliance and had a basis to impose enforcement remedies.

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****Petitioner rebutted CMS' *prima facie* case and established by a preponderance of evidence that it was in substantial compliance with Medicare participation requirements during the relevant time period.**

	**The relevant Medicare participation requirements are 42 C.F.R. §§ 483.24 and 483.25.****As noted in the previous section, CMS cited Petitioner for G-level deficiencies relating to Quality of Life and Quality of Care participation requirements for long-term care facilities (Tag F-309).  CMS Ex. 2 at 1-2; *see* 42 C.F.R. §§ 483.24, 483.25(k), and 483.25(*l*).  Section 483.24, which pertains to Quality of Life, states, in pertinent part:

Each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, consistent with the resident's comprehensive assessment and plan of care.

42 C.F.R. § 483.24.

CMS cited Petitioner for Quality-of-Care deficiencies with specific reference to sections 483.25(k) and (*l*).  CMS Ex. 1 at 5; CMS Ex. 2 at 1-2.  Those sections concern participation requirements for treatment and care related to "Pain Management" and "Dialysis," respectively.  However, those sections do not apply to the specific facts of the January 2017 complaint survey because CMS did not allege any violations in the pain management or dialysis care of Resident #1.  *See generally* CMS Exs. 1-2; 42 C.F.R. § 483.25(k), (*l*); P. Post-hearing Br. at 4 (stating "No allegations relate to [42 C.F.R. §] 483.25(k) or (l)," which CMS does not dispute).

Nevertheless, the general participation requirements at section 483.25 apply.  Section 483.25, relating to Quality of Care, states, in pertinent part:

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.  Additionally, residents have "[t]he right to request, refuse, and/or discontinue treatment."  42 C.F.R. § 483.10(c)(6); *see also* 42 U.S.C. § 1395i-3(c)(1)(A)(i) (stating that residents have "[t]he right . . . to participate in planning care and treatment or changes in care and treatment."); 42 U.S.C. § 1395i-3(c)(1)(A)(v)(I)

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(stating that residents also have the right "to reside and receive services with reasonable accommodation of individual needs and preferences . . .").

Chapter 7 and Appendix PP ("Guidance to Surveyors for Long Term Care Facilities") of the SOM provide protocols and interpretive guidelines to surveyors for conducting nursing home surveys and enforcing Medicare/Medicaid program participation requirements.  SOM, CMS Pub. 100-07, ch. 7, § 7000 (Rev. 63, eff. Sept. 10, 2010) (explaining that "Chapter 7 implements the nursing home survey, certification, and enforcement regulations at 42 CFR Part 488.").  According to the guidance related to Tag F-309 in Appendix PP of the SOM:

The facility must ensure that the resident obtains optimal improvement or does not deteriorate within the limits of a resident's right to refuse treatment, and within the limits of recognized pathology and the normal aging process.

SOM, CMS Pub. 100-07, ch. 7, App. PP (Rev. 41, eff. Apr. 10, 2009).9

According to Appendix PP, guidance related to Tag F-309 is "for review of quality of care not specifically covered by 42 [C.F.R. §] 483.25(a)-(m)."  SOM, CMS Pub. 100-07, ch. 7, App. PP (Rev. 41, eff. Apr. 10, 2009).  Thus, "Tag F-309 includes, but is not limited to, care such as end-of-life, diabetes, renal disease, fractures, congestive heart failure, non-pressure-related skin ulcers, pain, or fecal impaction."  *Id.*

****The facts establish that Petitioner appropriately managed Resident #1's diabetes.****The evidence of record establishes that Resident #1 was an 84-year-old, non-insulin-dependent diabetic.  CMS Ex. 6 at 27-28, 56; Tr. at 34.  At the time of the January 2017 complaint investigation, her most recent care plan (dated September 28, 2016) and most recent MDS quarterly review assessment (dated November 17, 2016) state that she was incontinent of bladder and bowel; wheelchair-bound with muscle wasting/atrophy and gait issues; had cognitive deficits, dysarthria, and dysphagia related to cerebrovascular disease; and was on a diabetic diet consisting of LCS/NAS (Low Concentrated Sweets/No Added Salt), regular texture, and regular/thin Liquids consistency.  CMS Ex. 6 at 24-29, 35, 41, 46-48, 52.  She also had hypertension, heart disease, an implanted pacemaker, and bipolar disorder, among other health conditions.  CMS Ex. 6 at 23, 25-26, 28-29, 47-48.  She required one or two people to assist her with activities of daily living.  CMS Ex. 6 at 27, 40-41.

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According to Nursing Progress Notes dated September 22, 2016, Resident #1 was taking Metformin, an oral diabetes medication to control blood sugar levels, and was having chronic episodes of watery stool.  CMS Ex. 6 at 107; CMS Ex. 8 at 13.  At the time, her blood sugar was monitored with Accuchecks every week, once a day in the morning, every seven days, per orders dated August 13, 2016.  CMS Ex. 6 at 98.  A nurse practitioner named "Candice" ordered the discontinuation of Metamucil, put Metformin on hold for seven days, ordered "FSBS" in the morning daily for seven days, and a reassessment in seven days.10  *Id.* at 107.  Resident #1's glucose level was recorded as 121 mg/dl on September 22, 2016.  *Id.*  In terms of diet, Resident was on an LCS, NAS diet of regular consistency.  *Id.*

On September 30, 2016, Resident #1's Nursing Progress Notes state that Resident #1's Metformin was on hold for seven days with Accuchecks in the morning.  *Id.*  Resident #1's blood sugar was elevated with Metformin on hold, but her diarrhea had decreased to only one episode in a week.  *Id.*  The nurse practitioner wrote new orders decreasing Resident #1's Metformin to 500 mg by mouth twice daily and to perform a hemoglobin A1C (HgbA1C or A1C) test in one month.11  *Id.*  Resident #1's son, who is her responsible party for medical decisions, agreed with the new plan of care.  *Id.*  As the order for daily Accuchecks lasted for only seven days, Resident #1's weekly Accuchecks resumed on October 2, 2016.  *Id.* at 12.  Although Resident #1's FSBGs were performed on October 2 and 9, 2016, the values were not recorded in her electronic medical record.  *Id.*

On October 14, 2016, Resident #1 was examined by Ms. Richey, a geriatric nurse practitioner, for having "diarrhea every day per staff."  *Id.* at 96.  Ms. Richey noted that the diarrhea had abated when Resident #1 was off Metformin for a week and had resumed when she started taking a low dose of Metformin.  *Id.; see also* P. Ex. 5 at ¶ 7.  Ms. Richey documented that Resident #1's FSBG was recorded as 205 mg/dl and her most recent A1C from August 15, 2016, was 6.8%, which was higher than her previous A1C of 5.7 on November 17, 2015, but still under the recommended "treatment goal of 7% for diabetic patients."  CMS Ex. 6 at 93, 96.  Ms. Richey wrote orders to discontinue Metformin; to start Tradjenta (an oral diabetes medication), 5 mg/day; and to perform FSBG every morning "(for now)."  *Id.* at 96; *see also id.* at 94, 100.  Later that same day, a licensed vocational nurse informed Resident #1's son of the new orders, and he objected to daily finger stick checks.  P. Ex. 5 at ¶ 9; *see also* CMS Ex. 6 at 94, 106; P.

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Ex. 6 at 2.  Because Resident #1's son could not be persuaded to agree to daily finger stick checks, Ms. Richey "discontinued the order for FSBG checks each morning and issued a new order for blood sugar checks once a week, which had been the order in place."  P. Ex. 5 at ¶¶ 9-10; *see also* CMS Ex. 6 at 94 (physician order sheet stating in the lower right corner "n/o BS once a week. DC check FSBG QAM").  The Nursing Progress Note, dated October 14, 2016, also stated "[k]eep blood sugar checks Q [every] week" following a discussion with Resident #1's responsible party about her new orders.  CMS Ex. 6 at 106; P. Ex. 6 at 2.

On October 16, 2016, Resident #1's weekly FSBG was checked and initialed as performed in the morning ("Morni"), but the value was not recorded in her electronic medical record.  CMS Ex. 6 at 12.  According to the Chart Codes in the lower left corner, a check mark indicates that the service was "Administered," but the box above it for entering the blood sugar ("BS") value has an "x" mark instead of a number.  *Id.*  Thus, the FSBG was performed, but the blood glucose level was not recorded.  On October 23, 2016, her FSBG was recorded as 113 mg/dl.  *Id.*  On October 30, 2016, Resident #1's FSBG was recorded as 220 mg/dl.  *Id.*  Resident #1's A1C was checked on October 31, 2016, as previously ordered.  *Id.* at 93, 107.  Her A1C was 8.1%, which was an increase from her previous level of 6.8% on August 15, 2016.  *Id.* at 90, 93.

On November 6, 2016, Resident #1's weekly FSBG was checked and recorded as 186 mg/dl.  *Id.* at 68.  Resident #1's FSBG was checked on November 13, 2016, but the value was not recorded.  *Id.*  On November 20, 2016, her FSBG was recorded as 442 mg/dl.  *Id.*  Petitioner's staff alerted Ms. Richey of Resident #1's high FSBG.  Tr. at 71.

The following day, on November 21, 2016, Ms. Richey performed an examination of Resident #1.  CMS Ex. 6 at 92, 106.  Ms. Richey testified that she "saw [Resident #1] the very next day because the staff alerted [her] of that [FSBG] number."  Tr. at 71.  She noted Resident #1's four previous documented FSBG readings (442 mg/dl, 186 mg/dl, 220 mg/dl, 113 mg/dl) and two previous A1C values (8.1% and 6.8%).  CMS Ex. 6 at 92.  According to Ms. Richey's evaluation form, Resident #1 denied any new issues, and Resident #1's daughter was present and also denied any concerns.  *Id.* at 92.  Resident #1 was assessed as having hyperglycemia, among other conditions.  *Id.*  Ms. Richey ordered the addition of 15 mg of Actos daily (an oral diabetes medication) and Accuchecks every morning.  *Id.* at 73, 92, 106.  Resident #1's responsible party was informed of the new orders.  *Id.* at 106.

According to her electronic medical record, Resident #1's FSBG was not checked on November 21, 2016 through November 26, 2016, but was checked again on the seventh day, November 27, 2016.  *Id.* at 68.  On November 27, 2016, Resident #1's FSBG was recorded to be 286 mg/dl, a significant decrease from her previous level of 442 mg/dl on November 20, 2016.  *Id.*

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On November 29, 2016, Ms. Richey examined Resident #1 for erythema, rash, and pruritus of the genitals and perianal region.  *Id.* at 90.  In addition to making assessments, diagnoses, and orders concerning the rash, Ms. Richey noted Resident #1's six previous documented FSBGs (286 mg/dl, 442 mg/dl, 186 mg/dl, 220 mg/dl, 113 mg/dl, and 151 mg/dl) and most recent A1C of 8.1%.  *Id.*  Resident #1 was assessed to have candidiasis and hyperglycemia, among other conditions.  *Id.*  Ms. Richey noted that Resident #1 had been taking Actos for a week and that she may need to increase her dosage.  *Id.*  She also noted that Resident #1's son reported a regular Coke in her room and did not want her to get anymore.  *Id.*  According to the Nursing Progress Note, dated November 29, 2016, Resident #1's son had a:

concern that they have changed her diabetic medicine and started checking her blood sugar again, however there have been several times when he or his sister has been here and there has been a regular coke in her room or on her tray.  He requested that whoever is giving her regular coke to stop it. This nurse assured him that charge nurse, ADON< and DON would be made aware of this.  He was very appreciative.

*Id.* at 106.  Resident #1's FSBG was not checked again until the seventh day, December 4, 2016.  *Id.* at 1.  Her level was recorded as 286 mg/dl, which was the same as the previous week.  *Id.*

On November 29, 2016, Resident #1's treatment nurse notified Amy Williams, Petitioner's Administrator, and the Director of Nursing (DON) that Resident #1's son reported concerns about his mother's treatment orders and her receiving regular Coke.  P. Ex. 8 at 1-2, 4.12  Ms. Williams, the DON, and Assistant DON (ADON) investigated the complaint:

ADON/DON spoke with Charge Nurses regarding the above concern.  Charge Nurse states residents [sic] sister was in the dining room during lunch and observed a coke on the table.  The coke was not on the residents [sic] tray and belonged to another individual.  Charge Nurse could not remember the exact date but no concerns were voiced by the sister at that time.  Further investigation revealved [sic] that nurses and CNA's [sic] do not recall purchasing or serving cokes to resident.

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*Id.* at 4; *see also id.* at 2.  Ms. Williams determined that there was no indication in the grievance or her investigation that a coke was ever observed in Resident #1's room.  *Id.* at 2.

On December 1, 2016, Ms. Williams reported the results of the investigation to Resident #1's son:

Admin. spoke with [Resident #1's son] and informed [him] of findings.  Son [was] appreciative of follow-up call and stated he has not witnessed this but [it] was shared with him by his sister.  Will monitor and address any further concerns.

*Id.* at 4.

At approximately 1:10 P.M. on December 10, 2016, Resident #1 was noted to be lethargic, unable to swallow thin liquids without coughing, and having poor respiratory effort due to lethargy.  CMS Ex. 6 at 105.  The registered nurse consulted Resident #1's physician and new orders were received for nectar liquids, IV fluids, oxygen support at two liters per minute via nasal cannula, and various laboratory tests, consisting of a CBC (Complete Blood Count), a CMP (Comprehensive Metabolic Panel), a UAC&S (Urinalysis, Culture and Sensitivity), and a STAT CXR (immediate chest x-ray).  *Id.*  Resident #1's responsible party (her son) was called and received an update.  *Id.*

At 2:17 P.M. on December 10, 2016, Resident #1 was transferred to Tomball Regional Medical Center for altered mental status.  *Id.*  Her most recent set of vital signs were reported on the transfer paperwork, including a blood sugar level of 500 mg/dl, which was taken at 2:24 P.M.  *Id.*  Resident #1's blood pressure was 117/54 mmHg; her pulse was 86 bpm; her respiration rate was 16 breaths per minute, her temperature was 96.7 degrees Fahrenheit; and her oxygen level on room air was 88%.  *Id.*  Petitioner also provided information concerning "existing skin/wound issues and care/treatment orders and frequencies, behavioral issues, interventions and any additional relevant information for [Resident #1]."  *Id.*  Current medication administration records, treatment administration records, and active physician orders were sent with the transfer paperwork to the hospital.  *Id.*

Resident #1 presented at the hospital's Emergency Department (ED) with an altered mental status.  *Id.* at 115.  She was disoriented and had decreased responsiveness.  *Id.*  According to the ED report, her onset of symptoms occurred just prior to arrival at the ED, was "moderate" in degree initially, and was "minimal" when examined at the ED.  *Id.*  According to ED records, Resident #1 went:

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to the ED BIBEMS [Brought in by Emergency Medical Services] after they were called from the NH [Nursing Home] for dehydration.  Patient [Resident #1] was apparently eating food 5 minutes prior and when EMS arrived she was very lethargic responsive to only sternal rub.  Patient [Resident #1] has a pacemaker., is diabetic [and] had a sugar that was HI [high]. . . .

*Id.*  Her temperature was 98.5 degrees Fahrenheit; her respiratory rate was 18 breaths per minute; her pulse rate was 67 bpm; her blood pressure was 141/51 mmHg; and her oxygen level was 96% on 4 liters per minute.  *Id.* at 116.

Initially, the ED was not able to obtain a review of systems due to her altered mental status.  *Id.* at 115.  Subsequent examination by the ED revealed that Resident #1 was in mild distress and lethargic.  *Id.* at 116.  Her systems were found to be normal.  Her skin was warm, dry, and pink.  *Id.*  Her pupils were equal, round, and reactive to light and her extraocular movements were intact.  *Id.*  Resident #1's mucous membranes were dry.  She had a regular heart rate and rhythm, no murmur, normal peripheral perfusion, and a pacemaker was noted in her left chest.  *Id.*  Her lungs were clear to auscultation, respirations were non-labored, and breath sounds were equal.  *Id.*  She had no focal neurological deficits, had normal speech, was responsive to sternal rub, and moved her extremities in response with incomprehensible sounds.  *Id.*  She was cooperative.  *Id.*

The ED ordered various tests, including an electrocardiogram, chest x-ray, CT of the head or brain without contrast, bloodwork, and a urine sample.  *Id.* at 116-18, 124-25.  Notably, Resident #1's glucose, creatinine, BUN (blood urea nitrogen), sodium, and neutrophils levels were high at 2:58 P.M.13  *Id.* at 117-18, 142-43.  Her glucose was 871 mg/dl; creatinine was 1.62 mg/dl; BUN was 65 mg/dl; sodium was 155 mmol/l; and neutrophils were 74.3%.  *Id.*  Resident #1's blood was tested again approximately 10 minutes later, at 3:09 P.M.  *Id.* at 117.  Her sodium and BUN levels remained the same or around the same level, but her creatinine decreased to 1.2 mg/dl, which was within normal range, and her glucose was reported as high again, at >700 mg/dl.  *Id.*  Resident #1's glucose levels continued to drop to 642 mg/dl at 5:41 P.M. and to 539 mg/dl at 6:53 P.M.  *Id.* at 160.  Similarly, Resident #1's BUN and creatinine decreased when tested again at 5:41 P.M. and 6:53 P.M. (BUN to 52 mg/dl and 47 mg/dl and creatinine to 1.1 mg/dl and 1.0 mg/dl, respectively).  *Id.* at 160.  At those same times, Resident #1's

Page 19

sodium was 162 mmol/l and then increased to 163 mmol/l.  *Id.* at 159-60.  It does not appear that her neutrophils level was retested.  *Id.* at 159-61.  Resident #1's urine sample included abnormal amounts of ketones and blood.  *Id.* at 132.  Her urine culture results revealed "[g]reater than 100,000 colonies/ml [of] Escherichia coli [E. coli]."  *Id.* at 162.
Resident #1's ED treatment consisted of an indwelling urinary catheter and insulin infusions.  *Id.* at 127-28.  Her blood glucose was checked hourly for approximately 24 hours.  *Id.* at 125-27.  She was discharged from the ED at 7:12 P.M. on December 10, 2016.  *Id.* at 123.  She was stable and was admitted to inpatient care at the hospital's Critical Care Unit (CCU).  *Id.* at 112, 119.  Her discharge diagnoses were acute renal failure, HHNC, and hypernatremia.  *Id.* at 119, 123.

At 9:31 P.M. on December 10, 2016, a Nursing Progress Note reflects that Resident #1's son called Petitioner, was very upset, and asked to speak with the DON or the Administrator.  *Id.* at 104.  The substance of the conversation was not documented, but the record noted that "the receptionist was the primary person that spoke [to] the Residents [sic] son and the administrator."  *Id.*  I infer that Resident #1's son called Petitioner to provide an update on his mother's status and to discuss her hospitalization.

Although Resident #1 initially was admitted to the CCU, it appears she was transferred to the hospital's Progressive Care Inpatient (PCI) unit at some point and remained hospitalized at least through December 15, 2016.  *See generally* CMS Ex. 6 at 112-63 (caption on hospital records identifying the "Service Code" as "PCI PROGRESSIVE CARE INPATIENT"); *see also id.* at 145 (indicating what appears to be Resident #1's last "Glu POC Bdside" (Point-of-Care bedside glucose) testing, which was collected on December 15, 2016, at 12:11 P.M. and recorded as 282 mg/dl).  While hospitalized, Resident #1's glucose levels continued to fluctuate, but also dropped.  At 9:23 P.M. on December 10, 2016, her glucose was recorded at 433 mg/dl.  *Id.* at 142.  Over the next five days, her glucose fluctuated significantly, ranging from a low of 55 mg/dl on December 12, 2016, at 1:07 A.M. to a high of 357 mg/dl on December 11, 2016, at 9:38 A.M., and on December 13, 2016, at 4:58 P.M.  *Id*. at 141, 148, 152; *see Id*. at 132-41, 145-59.  It appears based on the hospital records in evidence that the last reported glucose level was 282 mg/dl on December 15, 2016, at 12:11 P.M.  *Id.* at 145.

Resident #1's sodium, BUN, and creatinine levels decreased steadily between December 10 and 14, 2016.  Her sodium levels ranged from 164 mmol/l to 136 mmol/l; her BUN levels ranged from 65 to 18 mg/dl; and her creatinine levels ranged from 1.62 mg/dl to 0.52 mg/dl.  *Id.* at 133-34, 140, 142; *see also id.* at 135-39, 141.  It appears the last recorded levels during Resident #1's hospitalization were on December 14, 2016, at 5:30 A.M:  her sodium was 140 mmol/l; BUN was 18 mg/dl; and creatinine was 0.52 mg/dl.  *Id.* at 133.

Page 20

On December 11, 2016, the morning after Resident #1 was transferred to the hospital, Petitioner conducted an audit of Resident #1's Medication Administration Record (MAR).  CMS Ex. 2 at 6-7.  The ADON could not locate the physician's orders for November 21, 2016, so it appeared that Nurse C had implemented the orders from a physician's progress note.  *Id.* at 7.  Also, Nurse C had transcribed the orders for Actos and Pepcid, but she had not transcribed the order for an Accucheck every morning.  *Id.*  Nurse C was suspended pending the outcome of the investigation and subsequently was terminated for failing to enter the November 21, 2016 physician's orders correctly.  *Id.*  Nurse C had been written up previously and received one-on-one education for not entering all physician's orders and not implementing the physician's orders correctly for another resident.  *Id.*

On December 12, 2016, Petitioner provided in-service training to nurses, audited the MARs of the other 28 diabetic residents, and created a QAPI (Quality Assurance and Performance Improvement) project on transcription of physicians' orders.  CMS Ex. 2 at 8; CMS Ex. 8 at 4, 6-8; CMS Ex. 9.  Petitioner also drafted an undated QAPI report that was scheduled to be presented at the next meeting on January 18, 2017.  CMS Ex. 2 at 8; CMS Ex. 8 at 3-8; CMS Ex. 9 at 2.  Lastly, Petitioner conducted ongoing monitoring of physicians' progress notes and transcription of orders, beginning December 12, 2016.  CMS Ex. 2 at 8; CMS Ex. 8 at 4-5.

****Petitioner provided care and services that were consistent with professional standards and Resident #1's comprehensive assessment, plan of care, and right to refuse treatment, and, accordingly, Petitioner attained or maintained Resident #1's highest practicable physical, mental, and psychosocial well-being.****Based on the applicable law and my findings of fact, I conclude that Petitioner provided appropriate care and treatment to Resident #1 that was consistent with professional standards of care, her care plan, and her choices and right to refuse treatment.  42 C.F.R. §§ 483.25, 483.10(c)(6).  On October 14, 2016, Ms. Richey, the nurse practitioner who was treating Resident #1, changed her medication from Metformin to Tradjenta due to side effects and ordered daily Accuchecks, which requires finger sticks to obtain blood glucose readings.  *See* CMS Ex. 2 at 4; P. Ex. 5 at ¶¶ 7-8; Tr. at 68; CMS Ex. 6 at 94, 96; *see also* CMS Ex. 8 at 13 (listing diarrhea among possible side effects of Metformin).  Petitioner informed Resident #1's son of the new orders, and he refused to allow daily finger sticks.  P. Ex. 5 at ¶ 9; P. Ex. 6 at 2; CMS Ex. 6 at 106; Tr. at 67-68.  Therefore, Ms. Richey discontinued the daily finger sticks and changed back to weekly finger sticks immediately.  P. Ex. 5 at ¶¶ 9-10; P. Ex. 6 at 2; CMS Ex. 6 at 106.

The record reflects that Petitioner's staff appropriately implemented the revised orders for weekly finger sticks from October 14, 2016 through December 10, 2016.  CMS Ex. 6

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at 1, 12, 68.  Although the values of two finger sticks were not recorded in the MAR, Resident #1's MAR shows that her weekly finger sticks were actually performed.  *Id.* at 12, 68.  Thus, Petitioner followed its Diabetic Management policy of taking blood glucose measurements "per the physician order."  CMS Ex. 8 at 16.  I also find Ms. Richey's testimony to be credible and persuasive that monitoring Resident #1's blood glucose on a weekly basis was consistent with professional standards of care.  Tr. at 76-77.  While it is normal to monitor insulin-dependent diabetics with daily finger sticks, it is not common to do so for diabetics who do not take insulin, such as Resident #1.  *Id.* at 76.  Therefore, Ms. Richey was comfortable with continuing weekly finger sticks, as requested.  *Id.* at 77.  Although it would have been ideal to have daily finger sticks to monitor the medication change, Resident #1's legal representative refused daily finger sticks.  P. Ex. 5 at ¶ 9; Tr. at 76-77.

The fact that Resident #1 was hospitalized with hyperglycemia does not necessarily mean that Petitioner failed to manage her diabetes adequately.  Resident #1's Care Plan, last reviewed on September 28, 2016, included management of her diabetes.  Specifically, the Care Plan stated the following interventions:

Diabetes medication as ordered by doctor.  Monitor/document for side effects and effectiveness.
	Monitor/document my/families [sic] ability to manage the treatment program, i.e. medications, dietary, glucose monitoring, exercise and knowledge of complications.
	Monitor/document/report to MD PRN [as needed] s/sx [signs/symptoms] of hypoglycemia:  Sweating, Tremor, Increased heart rate (Tachycardia), Pallor, Nervousness, Confusion, slurred speech, lack of coordination, Staggering gait.
	Observe compliance with diet and document any problems.CMS Ex. 6 at 27.  The record reflects that Resident #1 received her diabetes medications (Metformin, Tradjenta, and Actos) as ordered from October 14, 2016 through December 10, 2016.  *Id.* at 7, 10, 19, 20, 73, 75.  As explained above, Petitioner also documented communications with Resident #1's son regarding her treatment plan, including medication changes, diet, and glucose monitoring.  *Id.* at 106-7; P. Ex. 5 at ¶¶ 9-10; P. Ex. 6 at 2.  Petitioner promptly investigated the son's complaint regarding whether its staff had given Resident #1 a regular Coke.  P. Ex. 8 at 1-2, 4.  Resident #1 did not have any hypoglycemic episodes during the relevant period, but I infer that Petitioner adequately monitored her for such symptoms because Petitioner monitored, documented, and promptly reported Resident #1's hyperglycemia symptoms, such as elevated FSBG and altered mental status, on November 21, 2016 and December 10, 2016, even though hyperglycemia was not expressly on her care plan.  *See, e.g.,* Tr. at 71; CMS Ex. 6 at 92, 104-06.  Additionally, I note that Petitioner's Diabetic Management policy addresses care

Page 22

for residents who have complications from low blood sugar levels.  Among other things, it states that if the level is "below 60 mg/dl (or physician designated low for the specific resident) and the resident is presenting with signs/symptoms of hypoglycemia, the physician shall be notified."  CMS Ex. 8 at 16-17.  Ms. Richey testified that she "would never want a sugar going below 120 on an 80-year-old."  Tr. at 76.  Although Resident #1 had an FSBG of 113 mg/dl on October 23, 2016, it does not appear that she had any signs or symptoms of hypoglycemia, and, thus, neither the physician nor NP were notified.  CMS Ex. 6 at 12.  Nevertheless, Nursing Progress Notes on October 20, 22, and 26, 2016, note that Resident #1 would have a HgbA1C test, the primary test for diabetes management, on October 30, 2016.  *Id.* at 106.

Although the care plan did not specify monitoring for hyperglycemia, Ms. Richey explained that, given her age and "delicate" condition, Resident #1 was at a greater risk of developing hypoglycemia than hyperglycemia.  Tr. at 69.  According to Ms. Richey, "[v]ery elevated sugar is a lot easier to pick up and treat . . . [and] worse-case scenario, obviously a hyperosmolar hyperglycemic nonketotic coma.  But usually that doesn't happen with an oral medication."  *Id.*  When asked about the benefit of more frequent blood glucose checks when starting a new diabetes medication, Ms. Richey explained that more frequent checks would "make sure that she wasn't going too low" and "probably would have given [her] a better idea [of] how she was reacting to the new medication."  *Id.*  However, Resident #1's son would not agree to more frequent blood glucose checks.  At the hearing, Capt. McElroy testified that the diabetes interventions on Resident #1's care plan were appropriate and agreed that "hypoglycemia is a more serious problem . . . . [D]iabetics can tolerate hyperglycemia quite well, up to a certain point, of course."  *Id.* at 57.  Thus, I conclude that Petitioner provided care that was consistent with her care plan, professional standards, and within the limits presented by Resident #1's right to refuse treatment.  As such, Petitioner attained and maintained Resident #1's "highest practicable physical, mental, and psychosocial well-being, consistent with the resident's comprehensive assessment and plan of care."  42 C.F.R. § 483.24.

Although Petitioner failed to transcribe the November 21, 2016, physician's orders for an Accucheck every morning, I do not conclude that Petitioner was out of substantial compliance because Resident #1 would not have agreed to them in any event.  Resident #1's son repeatedly refused daily Accuchecks for Resident #1, and I infer from record evidence that he most likely would have refused them on November 21, 2016.  CMS Ex. 6 at 94, 106.  Ms. Richey testified that:

[she] had talked to the son, Dr. Casagrande, my boss, had talked [to] the son ad nauseam, numerous times in the past.  It's well documented by both of us that we had discussed it with him over and over.  And he did not want his mother, who was close to death at that point, to be stuck on a daily

Page 23

basis, no matter what.  And he didn't even want them weekly, but he finally agreed to let us do it once a week . . . .

Tr. at 67-68.  Indeed, Ms. Richey testified, "to this day, her son refuses to do anything more than a weekly finger stick."  *Id.* at 78.  The record also reflects that Petitioner respected Resident #1's wishes and continued weekly Accuchecks.  CMS Ex. 6 at 1, 68, 94, 106; P. Ex. 5 at ¶¶ 9-10; P. Ex. 6 at 2.

Furthermore, Petitioner promptly audited Resident #1's physician orders and disciplined Nurse C for failing to follow its order transcription policies.  CMS Ex. 2 at 6-7.  In addition to suspending and ultimately terminating Nurse C, Petitioner swiftly provided in-service training and issued a QAPI report concerning transcription of physicians' orders.  *Id.* at 7-8; CMS Ex. 8 at 4-8; CMS Ex. 9.  I do not find that Nurse C's failure to transcribe the physician's order for daily Accuchecks caused Resident #1's hospitalization or rendered Petitioner out of substantial compliance with Medicare participation requirements.  Rather, Petitioner's corrective actions demonstrate that it was serious about maintaining and improving the safety and quality of care in its nursing home, while respecting its residents' rights.  *See generally* 42 C.F.R. §§ 483.10, 483.75.

Additionally, I am persuaded that Resident #1's elevated blood sugar requiring hospitalization "was due to the urinary tract infection she had at the time" and not because of any mismanagement of her diabetes or charting error.  P. Ex. 5 at ¶ 12; *see also* Tr. at 72, 77-78.  Petitioner's MAR indicates that on November 29, 2016, Petitioner treated Resident #1 for a UTI.  Resident #1 was given Diflucan, 150 mg, four times a day for ten days.  CMS Ex. 6 at 105-06.  Also, on November 29, 2016, Nursing Progress Notes reveal that Resident #1 had a new onset of a skin rash on her buttocks and genitals and began oral treatment with Diflucan, 150 mg daily.  *Id.* at 8, 106; *see also id.* at 74 (November 2016 MAR reflecting administration of Diflucan beginning November 30, 2016).  Resident #1 was monitored for adverse reactions over the next four days, and the rash was reported to be improving.  *Id.* at 105.  Resident #1's physician also ordered Miconazole Nitrate cream 2% to be applied to the affected area twice a day for 14 days.  *Id.* at 81.  Prior to November 29, 2016, Resident #1's MAR also includes orders for zinc oxide to be applied every day to her left buttock and for Allevyn wound dressings to be applied every Thursday and Monday as a preventative measure.  *Id.* at 78-80, 82, 84-86.

Among her lab test results at the ED on December 10, 2016, Resident #1's urine tested positive for E. coli.  *Id.* at 162.  Ms. Richey testified that:

the number one cause of the coma is infection.  So the fact that she had a urinary tract infection is the reason she had that, because a sugar of 800 is not going to happen in a person that doesn't have an infectious process and an electrolyte imbalance going on.  So there's no way we could have

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predicted that she was going to have a UTI and send her into that.  So fortunately, they did check it and send her out with a 500.

Tr. at 78.  Capt. McElroy also testified that the results of Resident #1's urine culture "would be diagnosed as a urinary tract infection."  *Id.* at 36.  He acknowledged that Resident #1 "was incontinent of bowel and urine, which makes her at high risk of a urinary tract infection."  *Id.* at 38.  He also testified that if "a diabetic patient has a urinary tract infection, there is going to be an increased demand for sugar.  And because the person's diabetic, they may not be able to move that sugar into the cells for it to be used by the immune system and so forth."  *Id.* at 37.

Petitioner also promptly investigated whether Resident #1 had been given a regular Coke and determined that the regular Coke was not on her food tray and belonged to someone else.  P. Ex. 8 at 1-2 (¶¶ 5-8); *Id.* at 4; CMS Ex. 6 at 106.  There is no credible evidence in the record establishing that Petitioner gave Resident #1 a regular coke, that Resident #1 actually consumed a regular Coke, or that Petitioner otherwise failed to follow Resident #1's LCS diet.  Although a charge nurse also observed a regular Coke on the table when Resident #1's sister was in the dining room during lunch, the Coke was not on Resident #1's tray and belonged to another individual.  P. Ex. 8 at 2 (¶ 7).  Additionally, no concerns were voiced by the sister at that time.  *Id.*  Moreover, "[t]here was no indication in the grievance or [the Administrator's] investigation of it that a [regular] Coke was ever observed in Resident #1's room."  *Id.* (¶ 8).  None of the nurses or aides recalled purchasing or serving a Coke to Resident #1.  *Id.* (¶ 7).

Thus, I conclude by the preponderance of evidence that Petitioner was in substantial compliance with Medicare participation requirements.  Petitioner provided care and treatment that was consistent with professional standards of practice and Resident #1's plan of care and right to refuse treatment.  42 C.F.R. §§ 483.10(c)(6); 483.25; SOM, CMS Pub. 100-07, ch. 7, Appx. PP (guidance related to Tag F-309).  Additionally, I find that the actions taken by Petitioner to manage Resident #1's diabetes were consistent with its Diabetic Management policy, reasonable, and practicable in light of the facts and circumstances of this case.  Resident #1's hospitalization due to hyperglycemia could not have been avoided, given the circumstances, including her age, diabetes mellitus, urinary tract infection, and right to refuse more frequent FSBGs.  Thus, Petitioner provided the necessary care and services to maintain Resident #1's highest practicable well-being.  42 C.F.R. § 483.24.

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****CMS's arguments of noncompliance are not persuasive because they are based on inaccurate facts and unreliable opinion testimony.****CMS insists that Petitioner did not follow orders for daily or weekly Accuchecks and "tests were not conducted for a full two weeks in the month of November."  CMS Post-Hearing Br. at 6.  However, as explained above, Resident #1's son would not agree to daily Accuchecks, and Petitioner actually performed weekly Accuchecks, although the blood glucose values were not recorded on a few occasions.  P. Ex. 5 at ¶ 9; Tr. at 67-68; CMS Ex. 6 at 1, 12, 68, 94, 106; P. Ex. 6 at 2.  CMS also alleges that "[t]here is nothing in [Resident #1's] records to indicate that Petitioner's staff notified [Resident #1's] physician or nurse practitioner of the elevated blood glucose numbers, or that any steps were taken to address the blood glucose results."  CMS Prehearing Br. at 3; *see also* CMS Prehearing Br. at 7-8; CMS Post-hearing Br. at 1, 4.  However, that is not true either.  For example, the record reveals that Petitioner's staff notified Ms. Richey of Resident #1's elevated blood glucose of 442 dl/mg on November 20, 2016.  Tr. at 71; CMS Ex. 6 at 68.  As a result, Ms. Richey examined her the next day and added Actos to her treatment.  Tr. at 71; CMS Ex. 6 at 73, 92, 106.  On November 27, 2016, Resident #1's blood glucose had fallen to 286 dl/mg and remained at 286 dl/mg on December 4, 2016.  CMS Ex. 6 at 1, 68.  Thus, Petitioner monitored Resident #1's blood glucose and responded to elevated levels by adding a second medication.  As a result, Resident #1's blood glucose levels were trending downwards.  Petitioner could not have anticipated that the following week, on December 10, 2016, her blood glucose would rise to 500 dl/mg and that Resident #1 would require hospitalization.  *Id.* at 105.

In its prehearing brief, CMS also alleged that Resident #1's son "noted that [Resident #1] should be having her blood sugars checked, and that he and his sister had found regular Coke cans on [Resident #1's] dining tray on several occasions."  CMS Prehearing Br. at 2.  CMS also argues that "[t]here is no evidence that [Petitioner] investigated to determine if [Resident #1] was receiving an appropriate beverage with her meal, or if [Resident #1's] blood sugar levels were negatively affected by drinking regular Coke."  CMS Prehearing Br. at 8; *see also* CMS Ex. 29 at 4 (opining that Petitioner "failed to control Resident #1's sugar intake").  However, these allegations are also factually incorrect.  Resident #1's son was concerned that his mother was having her blood sugars checked again.  CMS Ex. 6 at 106 (Nov. 29, 2016 Nursing Progress Note stating Resident #1's son had "a concern that they have changed her diabetic medicine and started checking her blood sugar again . . .").  Also, Petitioner did, in fact, investigate his concerns about the regular Coke and determined that a regular Coke was never on her tray.  CMS Ex. 6 at 106; P. Ex. 8 at 1-2, 4.  When the ADON reported the results of the investigation into regular Cokes to him, Resident #1's son was appreciative and revealed that he had not personally seen a regular Coke in his mother's room.  P. Ex. 8 at 4.  Thus, the record reflects that Petitioner immediately investigated whether Resident #1

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consumed a regular Coke and determined it did not belong to her and was not on her food tray.

CMS also faults Petitioner for possibly not fully explaining to Resident #1's son why daily finger sticks were necessary.  Tr. at 54.  CMS's Registered Nurse Consultant, Capt. McElroy, testified that he:

didn't see anything that indicated the responsible party was clearly informed of why that frequent – frequency of blood sugar checks was necessary. . . . My problem really was is [sic] that it was presented to the son.  The son says, you know, I really don't want to bother mom.  You know, I have no idea how the interchange went. . . . That's to me the non-compliance issue in this situation, is making sure that that was informed decision on the part of the responsible party.

Tr. at 54-55.  Contrary to Capt. McElroy's testimony, the record reveals that Petitioner did notify Resident #1's legal representative about the need for daily finger sticks and documented that it was refused.  CMS Ex. 6 at 94, 106.  Ms. Richey also testified that she and Dr. Casagrande had talked to the son "*ad nauseam"* about daily finger sticks and he finally agreed to let Petitioner do it once a week.  Tr. at 67-68 (emphasis added).  I find no evidence supporting Capt. McElroy's speculation that the son's objection to daily finger sticks was not an informed decision.

Capt. McElroy's testimony also ignores Petitioner's duty to respect its residents' choices and right to participate in the planning of care and treatment.  42 C.F.R. § 483.25; 42 U.S.C. § 1395i-3(c)(1)(A)(i).  Residents have the right to refuse treatment.  42 C.F.R. § 483.10(c)(6).  The evidence establishes that Resident #1's son refused daily FSBGs for Resident #1.  CMS Ex. 6 at 94, 106; P. Ex. 5 at ¶¶ 9-10; Tr. at 67-68.  Petitioner cannot coerce residents to accept treatment or administer treatment against a resident's wishes.  Indeed, to do so could constitute possible abuse or criminal assault.  Capt. McElroy also suggests that Petitioner could have reported Resident #1's responsible party for not acting in her best interest.  Tr. at 54-56.  But I find that recommendation to be inappropriate and unnecessary here.  The responsible party clearly acted in his mother's best interest when he relayed concerns about his mother receiving a regular Coke, even though he had not witnessed it personally.  He was grateful that Petitioner quickly investigated and determined that she had not received any regular Coke.  P. Ex. 8 at 4.  Also, Resident #1's son did not object to all treatment but allowed medication changes and other treatment that she received for diabetes, a UTI, rash, and other conditions.  CMS Ex. 6 at 94, 106-07.  Thus, Petitioner had no genuine reason to believe he was not acting in his mother's best interest when he refused daily finger sticks.  I find that the son's decision to continue weekly FSBGs was an informed decision.

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I also find that Petitioner's compliance with that decision was within professional medical standards.  Ms. Richey explained that, although daily FSBGs would be "textbook" or "preferred," she felt comfortable staying with weekly FSBGs because Resident #1 is over 80 years old and a non-insulin-dependent diabetic.  Tr. at 68, 76; P. Ex. 5 at ¶ 9.  She testified that she does not order daily finger sticks for 80-year-old patients or "any of [her] patients who are not on insulin."  Tr. at 68, 76.  She also testified that Resident #1's son did not want Petitioner to do daily finger sticks; "he had talked to [Petitioner] repeatedly, yelled at [Petitioner], about not doing it," and Resident #1 "got very upset when [Petitioner] would do it."  *Id.* at 76.  Unlike Ms. Richey, Capt. McElroy is not a geriatric nurse practitioner and is not authorized to make medical diagnoses or order treatment, including blood glucose testing or medications for diabetes.  *Id.* at 11-12.  At the hearing, he also agreed that it is the prerogative of the physician or nurse practitioner "to determine the appropriate parameters for following blood glucose levels and for modifying medical treatments[.]"  *Id.* at 12.  Therefore, I accord Capt. McElroy's testimony little weight as it relates to the proper standard of care for treating Resident #1's diabetes.

In addition to his lack of experience and qualifications to diagnose medical conditions and order treatment, Capt. McElroy's testimony was inconsistent and relied on incorrect facts and assumptions stated in the survey report.  For example, the survey report stated that "FSBG" stands for "Fasting Blood Glucose," but it actually stands for "Finger-Stick Blood Glucose."  *See, e.g.*, CMS Ex. 2 at 4; Tr. at 22; CMS Ex. 29 at 4.  In his testimony, Capt. McElroy acknowledged the survey report's error and explained that a FSBG "is a laboratory test that uses capillary blood and a glucometer to indicate blood sugar levels," whereas a "fasting blood glucose [test] is a different kind of blood glucose test which must be performed on venous blood by a CLIA-certified laboratory."  CMS Ex. 29 at 4-5.  He stated that a FSBG "wouldn't be used for a fasting blood sugar because it's capillary blood."  Tr. at 21.  Despite acknowledging the surveyor's misunderstanding of the acronym FSBG and the distinction between FSBGs and fasting/venous blood glucose tests, Capt. McElroy testified that "normal serum (venous blood) glucose is 70 to 110 [mg/dl]," and relied on that range to opine that FSBGs of 186 and 286 mg/dl were "high" for Resident #1 and Petitioner failed to notify the NP or physician about the high blood sugars.  CMS Ex. 29 at 4, 5-6; *see also* Tr. at 20 (testifying that "a normal range of blood glucose on a fasting test" is "[g]enerally speaking . . . 70 to 110 milligrams per deciliter.").  He also testified that "the blood sugars that were obtained required nurses to reduce Resident #1's sugar intake."  CMS Ex. 29 at 4.  I also note that Capt. McElroy testified that the "high" blood sugars "required nurses . . . to suggest to the NP that more frequent FSBGs were indicated until Resident #1's blood sugars could be normalized and stabilized on her new diabetic medications," but also testified inconsistently that "FSBGs are not to be used on unstable patients."  *Id.* at 4, 5.  It is incongruent to assert that more frequent FSBGs were required for Resident #1 and then argue that FSBGs were not to be used at all on her.

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Not only is Capt. McElroy's testimony inconsistent about the appropriate use or frequency of FSBG tests, but he provides an incorrect "normal" range or baseline for Resident #1's FSBGs.  As noted, he testified that a FSBG would not be used for fasting blood sugar but applied the normal range for fasting venous blood glucose (70 to 110 mg/dl) to assert that Resident #1's FSBGs of 186 mg/dl and over were "high" and not addressed properly by Petitioner.  CMS Ex. 29 at 4-5; Tr. at 21; *see* Tr. at 58.  However, Ms. Richey testified credibly that a blood sugar of 186 mg/dl is "not an uncommon blood sugar nor alarming value for an 80[-]year[-]old diabetic patient."  P. Ex. 5 at ¶ 11.  She further explained that "[i]t does not indicate a change in condition or a potential need to alter treatment."  P. Ex. 5 at ¶ 11.  Given that "they're [FSBG tests] done two hours after the patient has eaten, anything under 250 [mg/dl] is the goal."  Tr. at 76.  Further, she "would never want a sugar going below 120 on an 80-year-old."  *Id.* at 76.  Ms. Richey also testified that she would not expect to be notified of Resident #1's blood glucose level unless it reached 400 mg/dl.  P. Ex. 5 at ¶ 11; Tr. at 71.  Petitioner's staff notified Ms. Richey when Resident #1's FSBG was 442 mg/dl, and she examined Resident #1 the following day.  Tr. at 71.  Capt. McElroy testified that he was not aware that Resident #1's finger sticks were taken in the morning two hours after a meal.  *Id.* at 32-33.  Considering his lack of qualifications to diagnose and order treatment for patients, reliance on inaccurate facts about Resident #1's FSBG readings, and reliance on inaccurate assumptions concerning fasting venous blood glucose, I accord Capt. McElroy's opinion testimony less weight.  Furthermore, I conclude that Petitioner followed its Diabetic Management policy of notifying the resident's physician or NP of blood glucose results outside of ordered parameters when it notified Ms. Richey of Resident #1's FSBG of 442 mg/dl on November 20, 2016.  CMS Ex. 8 at 16; Tr. at 71.  Petitioner was not required to notify Resident #1's physician or NP when her FSBGs were 186 mg/dl or 286 mg/dl.

In its post-hearing brief, CMS alleges that besides failing to respond to Resident #1's high blood sugar levels, Petitioner also failed to provide necessary care and services to Resident #1 when it failed to care plan for hyperglycemia, establish high/low blood sugar parameters for Resident #1, and provide diabetic monitoring in lieu of daily checks.  CMS Post-hearing Br. at 4.  CMS contends these failures began as early as mid-October 2016, when Resident #1's medication was changed.  *Id*.   However, these assertions are based largely on the testimony of Capt. McElroy.  *See id.* at 7-11.  I have already determined that his testimony is not persuasive because he lacks the professional qualifications to diagnose and order treatment for patients and relied on inaccurate facts and assumptions.  Thus, I find his opinions about Petitioner's alleged shortcomings in Resident #1's diabetic care to be unavailing.  Even Capt. McElroy agreed with Ms. Richey that "hypoglycemia is a more serious problem" and "diabetics can tolerate hyperglycemia quite well, up to a certain point, of course."  Tr. at 57.  Moreover, he testified that he personally had never set parameters for changing a patient's type or dosage of diabetes medication.  *Id.* at 12.  He assumes that blood glucose parameters were not set for Resident #1, but Ms. Richey explained that she did not expect to be

Page 29

notified of Resident #1's high blood sugar unless it hit 400 mg/dl, which Petitioner did when it tested 442 mg/dl on November 20, 2016.  P. Ex. 5 at ¶ 11; CMS Ex. 6 at 68, 92, 106; Tr. at 69-71.  She also testified that she "would never want a sugar going below 120 on an 80-year-old."  Tr. at 76.  In regard to monitoring diabetics for signs and symptoms, Capt. McElroy acknowledged that "the finger-stick blood glucose is still your best measure of what's going on with a patient when you're concerned about what their blood sugars may be."  *Id.* at 58.

Nevertheless, the record also reflects that Petitioner monitored Resident #1 for signs and symptoms of diabetic complications.  Petitioner notified Resident #1's NP when she had diarrhea due to Metformin and her medications were changed in September and October 2016.  CMS Ex. 6 at 94, 96, 106-07.  Petitioner also notified Ms. Richey of an elevated blood sugar reading on November 20, 2016; Ms. Richey examined her the following day, assessed Resident #1 to have hyperglycemia, and added Actos.  *Id.* at 92; *see also id.* at 90 (examining Resident #1 on November 29, 2016, assessing her with hyperglycemia, noting that Actos may need to be increased, and noting that son reported a regular Coke in her room).  Likewise, Petitioner's staff noted that Resident #1 was lethargic and had an altered mental status on December 10, 2016.  *Id.* at 104-05.  Although it was not the day for her weekly FSBG, Petitioner checked it and had her transferred to the hospital's ED when the test revealed a blood glucose level of 500 mg/dl.  *Id.* at 104-05.  Petitioner also monitored Resident #1's glucose with orders for HgbA1C tests.  *Id.* at 93.  Ms. Richey examined Resident #1 when she had complications and noted her most recent, as well as previous, FSBG and HgbA1C test results.  *Id.* at 90, 92, 96.  Thus, Petitioner monitored Resident #1's diabetes and provided the necessary notifications and treatment.

Finally, I note that CMS contends that deficiencies related to Resident #1 predate the prior complaint investigation and annual survey completed on October 27, 2016.  CMS Post-hearing Br. at 4, 16; CMS Ex. 29 at 3-4; Tr. 63.  Although Resident #1 was interviewed during that survey, no concerns related to Resident #1's care, treatment, or MAR were identified at that time.  *See* CMS Ex. 24 at 11, 30, 58.  The surveyors did not identify any compliance issues related to Resident #1.  Although the absence of allegations concerning Resident #1 from the October 2016 survey is not dispositive nor would it preclude a finding of noncompliance based on the January 2017 survey, it is consistent with my findings of fact and ultimate determination that Petitioner was in substantial compliance with Medicare participation requirements.

Contrary to CMS' assertions, Petitioner did not fail to provide necessary care and services for Resident #1.  CMS Prehearing Br. at 7; CMS Post-hearing Br. at 2.  Petitioner appropriately managed Resident #1's diabetes by changing her medication when she experienced side effects, performing weekly Accuchecks of her blood glucose in accordance with her responsible party's wishes, adding a second diabetes medication when her blood sugar was elevated, investigating whether she received inappropriate beverages with her meals, and transferring her to the ED when her blood sugar reached

Page 30

500 mg/dl.  CMS Ex. 6 at 1, 12, 68, 94, 106; P. Ex. 8 at 4; Tr. at 67-68, 71.  Accordingly, I conclude that the preponderance of evidence in the administrative record establishes that Petitioner substantially complied with Medicare participation requirements during the relevant time.  Thus, CMS is not authorized to impose remedies against Petitioner for the January 2017 complaint investigation.  42 C.F.R. § 488.402(b) ("[T]he remedies are applied on the basis of noncompliance found during surveys conducted by CMS or by the survey agency."); *see also* 42 U.S.C. §§ 1395i-3(h)(2)(A), 42 C.F.R. §§ 488.400, 488.417(a), 488.430(a).

****Petitioner returned to substantial compliance on November 11, 2016.****Having determined that Petitioner was not out of substantial compliance with Medicare participation requirements based on the findings of the January 2017 complaint survey, I conclude that Petitioner returned to substantial compliance as of November 11, 2016.  The record evidence reveals that all deficiencies from the October 2016 surveys were corrected as of that date.  Specifically, the Post-Certification Reports state that the health and LSC deficiencies cited in the October 2016 surveys were corrected as of November 11, 2016.  P. Ex. 2.  Capt. McElroy also testified that all deficiencies from the recertification survey completed in October 2016 were corrected as of November 11, 2016.  Tr. at 62 (testifying that "all of the deficiencies from the recertification survey were corrected November 11[, 2016]."); Tr. at 45 (testifying that the December 2, 2016 correction date stated in his declaration (CMS Ex. 29 at 2) for the LSC deficiencies cited at the October 2016 survey (CMS Ex. 29) was incorrect and should be November 11, 2016); CMS Ex. 29 at 3 (testifying that the health deficiencies cited at the October 2016 surveys were corrected as of November 11, 2016).  Moreover, I note that "[f]or the October surveys, CMS is not contesting Tomball's allegation of compliance, which is dated November 11, 2016."  CMS Post-hearing Br. at 13.  Although a facility's correction of deficiencies alone does not necessarily mean that it has returned to substantial compliance, I find that the facts of this case warrant such a conclusion.  Petitioner corrected the October 2016 survey deficiencies as of November 11, 2016, and as discussed at length above, was in substantial compliance with Medicare participation requirements thereafter.

****A per-day CMP of $1,203 from November 6, 2016, through November 10, 2016, is a reasonable enforcement remedy.****I have concluded that Petitioner violated the Medicare participation requirements at 42 C.F.R. §§ 483.10(b)(11) (Tag F-157); 483.25(c) (Tag F-314); 483.25 and 483.25(d) (Tags F-315 and 309); 483.60(b), (d), (e) (Tag F-431); 483.75(*l*)(1) (Tag F-514); and 483.70(a) (Tags K-25, K-69, K-72) based on the undisputed facts of the October 2016 surveys.  ALJ Ruling No. 2021-6 at 2, 15-32.  I have also concluded that Petitioner returned to

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substantial compliance on November 11, 2016, and did not violate Medicare participation requirements based on the findings of the January 2017 survey.  Therefore, CMS has a basis to impose one or more enforcement remedies against Petitioner based on the findings of the October 2016 surveys.  42 U.S.C. §§ 1395i-3(h)(2)(A)-(B); 42 C.F.R. §§ 488.400, 488.406, 488.417(a), 488.430(a).

When CMS determines that a facility is not in substantial compliance with participation requirements and imposes remedies, the facility may appeal the findings of noncompliance leading to the imposition of remedies.  42 C.F.R. §§ 488.408(g)(1), 488.330(e)(3).  However, CMS' choice of remedy and the factors CMS considered when choosing a remedy are not subject to review.  42 C.F.R. § 488.408(g)(2).  I am constrained to determining whether the imposed remedies are reasonable.  When CMS imposes a DPNA, the Act provides that the "finding to deny payment . . . shall terminate when the Secretary finds that the facility is in substantial compliance with all the requirements . . . ."  42 U.S.C. § 1395i-3(h)(3); *see also* 42 C.F.R. § 488.417.

When determining whether the CMP imposed against Petitioner is reasonable, I consider 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 at 42 C.F.R. § 488.404; and (4) the facility's degree of culpability, which includes, but is not limited to, neglect, indifference, or disregard for resident care, comfort, or safety.  The absence of culpability is not a mitigating factor.  42 C.F.R. § 488.438(f)(4).  The factors listed at 42 C.F.R. § 488.404 are:  (1) the seriousness of the deficiency, including its severity and scope; (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.  I may not (1) set the CMP at zero or reduce it to zero; (2) review the exercise of discretion by CMS in choosing to impose a CMP; or (3) consider any factors other than those specified in 42 C.F.R. § 488.438(f).  42 C.F.R. § 488.438(e).  Unless a facility contends that a particular regulatory factor does not support the CMP amount, I must sustain it.  *Coquina Ctr.*, DAB No. 1860 at 32 (2002).

I review the reasonableness of the CMP *de novo* and based upon the evidence in the record before me.  *Fireside Lodge Ret. Ctr., Inc.*, DAB No. 2794 at 19 (2017).  I am neither bound to defer to CMS' factual assertions nor free to make a wholly independent choice of remedies without regard for CMS' discretion.  *See, e.g., Barn Hill Care Ctr.*, DAB No. 1848 at 21 (2002).  Rather, I consider whether the evidence supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found, and in light of the above factors.  I also must determine whether the amount of any CMP imposed is within reasonable bounds considering the purpose of the Act and regulations.  *Emerald Oaks,* DAB No. 1800 at 10 (2001); *CarePlex of Silver Spring*, DAB No. 1683 at 14-16 (1999); *Capitol Hill Cmty. Rehab. & Specialty Care Ctr.*, DAB No. 1629 (1997).

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In this case, CMS imposed an optional DPNA, beginning November 25, 2016, against Petitioner based on the findings of the October 2016 surveys.  P. Ex. 1 at 2; CMS Ex. 1 at 2; Act § 1819(h)(2)(B); 42 C.F.R. § 488.417(a).  CMS later added and revised the imposed remedies against Petitioner based on the findings of the January 2017 survey.  42 C.F.R. §§ 498.30, 498.32; *Britthaven of Goldsboro*, DAB No. 1960 (2005).  Specifically, on January 19, 2017, CMS added a per-instance CMP of $1,950.  CMS Ex. 1 at 5-6.  CMS later rescinded the per-instance CMP and imposed a per-day CMP of $1,203, from November 6, 2016, through December 12, 2016, and a per-day CMP of $303, beginning December 13, 2016 through January 26, 2017, the day before CMS determined Petitioner returned to substantial compliance.  The optional DPNA also ended on January 26, 2017.  CMS Ex. 1 at 12, 19.

As explained above, I concluded that Petitioner met its ultimate burden of persuasion proving that it was in substantial compliance with Medicare participation requirements based on the findings of the January 2017 survey.  Accordingly, CMS is not authorized to impose remedies against Petitioner for that survey.  According to Capt. McElroy, the optional DPNA applies solely to the January 2017 survey.  Tr. at 62 (correcting his declaration testimony that the DPNA applied to the LSC deficiencies); CMS Ex. 29 at 2-3.  Capt. McElroy further explained that "the DPNA would not apply to any of the deficiencies cited on the recertification survey [October 2016 surveys] . . . because the compliance date was before the DPNA started."  Tr. at 47.  Therefore, I conclude that CMS does not have a basis to impose the optional DPNA from November 25, 2016, through January 26, 2017, because it was based on the January 2017 survey.

According to Capt. McElroy, the per-day CMP applies to the health and LSC deficiencies from the January 2017 and October 2016 surveys.  CMS Ex. 29 at 2, 3.  In his declaration, Capt. McElroy testified that, with respect to the January 2017 survey, the per-day CMP applies from November 6, 2016, through November 10, 2016.  CMS Ex. 29 at 3.  However, at the hearing, Capt. McElroy testified that the end date of the CMP he stated in his declaration was incorrect and should be December 10, 2016, not November 10, 2016.  Tr. at 46.  Nevertheless, I have concluded that CMS does not have a basis to impose remedies for the health deficiencies from the January 2017 survey.  Accordingly, the per-day CMP would not apply to the January 2017 survey.

In contrast, I uphold CMS' imposition of the per-day CMP for the LSC and health deficiencies cited in the October 2016 survey.  Capt. McElroy initially testified in his declaration that the CMP for the LSC deficiencies from the October 2016 survey applied from November 6, 2016, through December 1, 2016, and the CMP for the health deficiencies from the October 2016 survey applied from November 6, 2016, through November 10, 2016.  CMS Ex. 29 at 2-3.  However, at the hearing, he testified that the end date of the CMP for the LSC deficiencies stated in his declaration was incorrectly based on the revisit date (December 2, 2016) instead of the date of compliance (November 11, 2016).  Tr. at 45.  He testified that the "correction date" should have been

Page 33

November 11, 2016, instead of December 2, 2016.  Tr. at 61.  At the hearing, he confirmed that the dates stated in his declaration concerning the CMP for the health deficiencies from the October 2016 survey were correct.  Tr. at 45.  When correcting his testimony about the DPNA, he also confirmed that "all of the deficiencies from the [October 2016] recertification survey were corrected November 11th[, 2016]."  Tr. at 62 (correcting his declaration testimony that the DPNA applied to the LSC deficiencies).  Thus, the per-day CMP of $1,203 would apply from November 6, 2016, through November 10, 2016, the day before Petitioner returned to substantial compliance.  According to Capt. McElroy, the CMP started on November 6, 2016, in part "to keep the CMP more reasonable, manageable, level for the facility."  Tr. at 63.  He testified that one of the considerations in setting the CMP start date was the "financial condition of the facility."  Tr. at 63.  Capt. McElroy also testified that the per-day CMP was lowered to $303 on December 13, 201614 to coincide with Resident #1's hospitalization.  Tr. at 64-65; CMS Ex. 1 at 19.

Petitioner asks that I find that no remedies are reasonable for the October 2016 surveys.  P. Post-Hearing Br. at 21.  As discussed above, I cannot review CMS' discretion to impose a remedy or its choice of remedy.  42 C.F.R. § 488.438(e).  Having sustained CMS' determination that Petitioner was out of substantial compliance in relation to the October 2016 surveys, I uphold the imposition of remedies for that period of noncompliance.  Based on Capt. McElroy's testimony, I find that the per-day CMP of $1,203 applies to the October 2016 surveys, while the DPNA and reduced per-day CMP of $303 apply to the January 2017 survey.  Accordingly, I review the reasonableness of the $1,203 CMP imposed from November 6, 2016, through November 10, 2016,15 based on the factors listed in 42 C.F.R. § 488.438(f).  Unless Petitioner contends that a particular regulatory factor does not support the CMP amount, I must sustain it.  *Coquina Ctr.*, DAB No. 1860 at 32.

The imposed per-day CMP of $1,203 from November 6, 2016 through November 10, 2016, is reasonable.  The undisputed deficiencies from the October 2016 surveys were cited at scope and severity levels "E" and "F," indicating a pattern and widespread deficiencies resulting in no actual harm with the potential for more than minimal harm

Page 34

that does not amount to immediate jeopardy.16  ALJ Ruling No. 2021-6 at 15-32.  At the time of the surveys at issue in this case, CMS was authorized to impose a CMP ranging from $103 to $6,188 per day for non-immediate jeopardy noncompliance.  42 C.F.R. § 488.438(a)(1)(ii); 45 C.F.R. § 102.3.  The per-day CMP may accrue until the facility achieves substantial compliance or its provider agreement is terminated.  42 C.F.R. § 488.454(a).  I note that the imposed CMP of $1,203 is on the lower end of the permissible range and ends on November 10, 2016, which is the last day of noncompliance.

Petitioner argues that no CMPs were recommended by the state agency or imposed by CMS for the October 2016 surveys.  P. Post-Hearing Reply at 8-9.  Although that contention appears to be true based on the initial enforcement letters Petitioner received from the state agency and CMS,17 CMS subsequently changed the remedies "[b]ased on a further administrative review."  CMS Ex. 1 at 12.  Capt. McElroy's testimony clarified that the DPNA does not apply to the October 2016 surveys, while the per-day CMP does apply.  Tr. at 47, 62; CMS Ex. 29 at 2-3.

Petitioner also suggests that application of CMS' CMP Analytic Tool warrants a lower CMP.  P. Post-Hearing Br. at 19; Tr. at 42-45.  As Capt. McElroy testified, use of the CMP Analytic Tool is not mandatory and serves only as guidance when CMS imposes a CMP.  Tr. at 43-44.  Nevertheless, he testified that he used the analytic tool.  *Id.* at 44.  Capt. McElroy also testified that he considered Petitioner's culpability and compliance history when setting the CMP.  *Id.* at 43, 45, 53-54; CMS Ex. 29 at 7.  Although CMS' culpability consideration focused primarily on the January 2017 survey (for which I found no violation), lack of culpability does not mitigate the CMP.  Therefore, I find no reason to reduce the CMP based on Petitioner's degree of culpability.  Indeed, Petitioner did not contest any facts related to the October 2016 deficiencies.

Petitioner also did not contest consideration of its compliance history in connection with the October 2016 surveys.  However, Capt. McElroy testified that he reviewed Petitioner's three-year history of noncompliance cycles since a survey completed on May 14, 2014, and learned this action is Petitioner's seventh noncompliance cycle and second enforcement action.  CMS Ex. 29 at 7.  Aside from its calculation of the value of claims during the DPNA window (P. Ex. 4), Petitioner did not present any evidence of its

Page 35

financial condition.  Upon consideration of the factors in 42 C.F.R. § 488.438(f), including the seriousness of the October 2016 survey deficiencies and Petitioner's degree of culpability, compliance history, and financial condition, I conclude that a per-day CMP of $1,203, beginning November 6, 2016, and continuing through November 10, 2016, is a reasonable remedy.  Moreover, I find that the CMP is reasonable, considering the purpose of the Act and regulations and CMS' enforcement authority to ensure that corrective action is taken to achieve Petitioner's compliance with Medicare participation requirements and to protect the public health.

VI.  Conclusion

For all the reasons discussed above, I conclude that Petitioner was not in substantial compliance with Medicare participation requirements based on the surveys completed on October 27, 2016.  However, I also conclude that Petitioner returned to substantial compliance on November 11, 2016, and remained in substantial compliance with Medicare participation requirements during the complaint investigation survey completed on January 4, 2017.  Accordingly, I conclude that CMS has a basis to impose remedies only for the deficiencies found at the October 2016 surveys, and a per-day CMP of $1,203, beginning November 6, 2016, through November 10, 2016, is a reasonable remedy.

Endnotes

1  My ruling dated July 9, 2021, articulates the factual findings of the October 2016 surveys, including the cited health and LSC deficiencies, and is incorporated in this decision.  Administrative Law Judge (ALJ) Ruling No. 2021-6 (2021).

2  "Revisit survey means a survey performed with respect to a provider or supplier cited for deficiencies during an initial certification, recertification, or substantiated complaint survey and that is designed to evaluate the extent to which previously-cited deficiencies have been corrected and the provider or supplier is in substantial compliance with applicable conditions of participation, requirements, or conditions for coverage.  Revisit surveys include both offsite and onsite review."  42 C.F.R. § 488.30(a).

3  *See* Section II *infra* for my ruling admitting Petitioner Exhibit 10 into the record.

4  Federal nursing home regulations substantially changed beginning on November 28, 2016.  81 Fed. Reg. 68,688 (Oct. 4, 2016).  The October 2016 surveys are governed by the previous version of the regulations, while the January 2017 complaint investigation is governed by the revised regulations.

5  Although Petitioner offered the Affidavit of Cindy Gabel, it did not list her as a witness.  *Compare* P. Ex. 4, *with* DAB E-File Docket Entry No. 9 at 2 (Petitioner's List of Proposed Exhibits and Witnesses, which identifies only Dezarei Richey and Amy Williams as witnesses).

6  HCFA (Health Care Financing Administration) changed its name to the Centers for Medicare & Medicaid Services (CMS) in 2001.  66 Fed. Reg. 35,437 (July 5, 2001).

7  As explained in the following section, there are no allegations concerning sections 483.25(k) and (*l*), but the general requirements of section 483.25 apply in this case.

8  A scope and severity level of "G" indicates that the deficiency was an isolated instance resulting in actual harm to a resident that was not immediate jeopardy.  State Operations Manual (SOM), CMS Pub. 100-07, ch. 7, § 7400.5.1 (Rev. 161, eff. Sept. 28, 2016) (applicable table at the time of the survey at issue) (pursuant to Rev. 185, issued November 16, 2018, the matrix currently appears at § 7400.3.1 of the SOM, but the substance is largely unchanged).

9  The SOM, Appendix PP uses "Tag" designations to identify alleged deficiencies of the regulatory requirements, such as "Tag F-309" cited in this case.

10  The progress notes show that the nurse practitioner ordered "FSBS" testing, which I interpret to mean "Finger Stick Blood Sugar" testing, which would be the same as ordering "FSBG" testing.  CMS Ex. 6 at 107.

11  As noted in Petitioner's post-hearing brief, the HgbA1c test is "the primary test for diabetes management" and "measures a patient's mean blood glucose level over the past 90 days."  P. Post-hearing Br. at 16.

12  In its post-hearing brief, Petitioner notes that the affidavit of Ms. Williams (P. Ex. 8) contains a typo.  Petitioner states that Ms. Williams was informed on November 29, 2016, of Resident #1's son's statement to the nurse concerning the Coke, not November 26, 2016.  P. Post-hearing Br. at 8 n.4.

13  High levels of glucose may lead to diabetes complications, such as HHNC.  CMS Post-hearing Br. at 1 n.3.  High levels of creatinine and BUN may be indicative of impaired renal function.  Kathleen Deska Pagana & Timothy J. Pagana, *Mosby's Manual of Diagnostic and Laboratory Tests* 191 (5th ed. 2014).  High levels of sodium in the blood may lead to a condition called hypernatremia.  *Id.* at 467.  High levels of neutrophils may be indicative of an acute bacterial infection.  *Id.* at 528.

14  CMS' counsel incorrectly stated that the CMP was lowered "as of December 10th."  Tr. at 64.

15  CMS concedes that the CMP end date should be November 10, 2016, if Petitioner is deemed to be in compliance as of the January 2017 survey.  CMS Post-hearing Br. at 14 n.13; CMS Post-Hearing Reply at 7 n.7.

16  Capt. McElroy corrected his declaration testimony to clarify that there was no finding of immediate jeopardy and the imposed CMP "is not an immediate jeopardy range CMP."  Tr. at 40-41.

17  *See* P. Ex. 1 at 2 and CMS Ex. 1 at 2 (state agency and CMS letters imposing the optional DPNA after the October 2016 surveys); P. Ex. 3 at 2 (recommending a per-instance CMP of $1,950 "for deficiency F309"); CMS Ex. 1 at 5 (imposing "$1,950.00 per instance for the instance on January 4, 2017, described at deficiency [Tag F-309].").
  
          /s/
        Karen R. Robinson

                      Administrative Law Judge Back to top
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