Town and Country Nursing and Rehabilitation Center, DAB CR6547 (2024)

DECISION

Petitioner, Town and Country Nursing and Rehabilitation Center (Petitioner), is a skilled nursing facility (SNF) located in Boerne, Texas, certified by and participating in the Medicare and Medicaid programs. Based on a survey completed on August 31, 2020, Respondent, the Centers for Medicare & Medicaid Services (CMS), determined Petitioner was not in substantial compliance with Medicare participation requirements. As a result of its determination, CMS imposed a $20,780 per-instance civil money penalty (CMP) against Petitioner. As explained herein, I grant CMS’s motion for summary judgment, affirm CMS’s imposition of penalties, and find the CMP selected by CMS reasonable.

Background and Procedural History

The Texas Health and Human Services Commission (THHSC or state agency) conducted a complaint investigation survey at Petitioner’s facility on August 31, 2020. CMS Ex. 2. The results of that survey led CMS to find Petitioner substantially noncompliant with Tag F600 (42 C.F.R. § 483.12(a)(1) – free from abuse and neglect) at the “J” scope/severity level, Tag F607 (42 C.F.R. § 483.12(b)(1)-(3) – develop/implement abuse/neglect policies) at the “J” scope/severity level, and Tag F684 (42 C.F.R. § 483.25 – quality of

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care) at the “J” scope/severity level.¹ CMS Ex. 1. THHSC found that conditions in the facility prior to the survey on August 31, 2020 constituted immediate jeopardy and also determined Petitioner’s noncompliance constituted substandard quality of care. CMS Ex. 2. On October 13, 2020, CMS imposed a per-instance penalty of $20,780 against Petitioner for noncompliance under Tag F684. CMS Ex 1.

On January 26, 2021, Petitioner challenged CMS’s action by filing a request for hearing in the Civil Remedies Division, resulting in my designation to hear and decide this case. Because Petitioner’s hearing request appeared untimely, I gave CMS leave to file a motion to dismiss if it believed Petitioner untimely filed its request for hearing without good cause. CMS did so, and Petitioner filed a response and four exhibits. On March 29, 2021, I found good cause for Petitioner’s untimely filing, denied CMS’s motion to dismiss, and issued an Acknowledgment and Pre-hearing Order (APHO) that set forth deadlines for the parties to file pre-hearing submissions, including briefs, exhibits, witnesses, and direct testimony for any proposed witnesses. APHO at ¶¶ 5-10.

On June 29, 2021, CMS filed a combined pre-hearing brief and motion for summary judgment (CMS Br.), 16 proposed exhibits (CMS Exs. 1-16), and two proposed witnesses. On July 29, 2021, Petitioner filed a combined pre-hearing brief and response in opposition to CMS’s motion for summary judgment (P. Br.), three proposed exhibits (P. Exs. 1-3), objections to CMS’s exhibits (P. Obj.), and a request for cross-examination of CMS’s proposed witnesses.

II. Admission of Evidence

Petitioner objected to CMS Exhibit 6, an Intake Investigation Worksheet, and CMS Exhibit 8, Surveyor Lan Nguyen’s survey notes, claiming both documents contain impermissible hearsay. P. Obj. at 1-2. Petitioner objected to CMS Exhibits 13 and 16, the declarations of two CMS witnesses, arguing they contain inadmissible hearsay, violate the best evidence rule by quoting documents not submitted into evidence, and fail

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to provide a factual or scientific basis for their opinions or comply with the standards for expert testimony set forth in “Daubert.” Id. at 2-3.²

I overrule Petitioner’s objections as they seek exclusion of evidence pursuant to the Federal Rules of Evidence, which do not strictly apply in these proceedings. Realhab, Inc., DAB No. 2542 at 4 (2013) (citing 42 C.F.R. § 498.61) (“Evidence may be received at the hearing even though inadmissible under the rules of evidence applicable to court procedure.”).

Similarly, the evaluation of opinion evidence required by Daubert and its progeny, embodied by F.R.E. 702, is inapplicable here. That rule provides a framework for a judge to assess scientific opinion evidence to protect lay factfinders from confusion concerning its validity. River City Care Ctr., DAB No. 2627 at 14 (2015). As the finder of fact in this matter, I hardly need afford such protections to myself. Id. Because Petitioner’s objections go to weight and not admissibility, I overrule them.

I admit CMS Exhibits 1-5, 7, 9-12, 14 and 15, and Petitioner Exhibits 1 through 3 into the record.

III. Scope of Decision

Petitioner challenges other deficiencies cited in the August 31, 2020 survey beyond Tag F684, namely those cited under 42 C.F.R. § 483.12(a)(1) (Tag F600) and § 483.12(b)(1)-(3) (Tag F607). P. Br. at 15-19. Petitioner reasons that other enforcement remedies may yet be imposed by the state agency, making Tags F600 and F607 appealable pursuant to 42 C.F.R. § 488.406(a)(9). Id. Petitioner’s claim is without merit. My jurisdiction does not stem from state agency deficiency findings or arise to preclude the possible imposition of remedies.

Instead, I may only review deficiencies upon which CMS relied to impose a remedy. See 42 C.F.R. §§ 488.406, 498.3(b). A SNF “has no right to an [administrative law judge] hearing to contest survey deficiency findings where CMS has not imposed any of the remedies specified in section 488.406 based on those findings.” Columbus Park Nursing & Rehab. Ctr., DAB No. 2316 at 6 (2010), dism. on other grounds, Columbus Park Nursing & Rehab. Ctr. v. Sebelius, 940 F. Supp. 2d 805 (N.D. Ill. 2013). It is the imposition of a remedy, not the citation of a deficiency, that triggers the right to a hearing. Schowalter Villa, DAB No. 1688 (1999); Arcadia Acres, Inc., DAB No. 1607

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(1997). Where CMS does not impose a remedy, Petitioner has no right to a hearing. Fountain Lake Health & Rehab., Inc., DAB No. 1985 (2005).

Here, CMS imposed a $20,780 per-instance CMP “for the instance on August 22, 2020 described at deficiency F684 (S/S: J).” CMS Ex. 3 at 1. Because CMS specifically imposed a CMP only for the deficiency cited under section 483.25 (Tag F684), this is the only deficiency properly before me in this case.

IV. Issues

A. Whether summary judgment is appropriate;

B. Whether Petitioner was in substantial compliance with Medicare participation requirements at 42 C.F.R. § 483.25 (Tag F684) at the time of the August 2020 survey;

C. If Petitioner was not in substantial compliance, whether CMS’s immediate jeopardy determination was clearly erroneous; and

D. If Petitioner was not in substantial compliance, whether the CMP imposed by CMS is reasonable.

V. Jurisdiction

I have jurisdiction to hear and decide this case. Soc. Sec. Act (Act) §§ 1128A(c)(2), 1819(h)(2)(B)(ii) (codified at 42 U.S.C. §§ 1320a-7a(c)(2), 1395i‑3(h)(2)(B)(ii)); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).

VI. Applicable Legal Authority for the Imposition of Penalties

The Act sets requirements for SNFs like Petitioner to participate in the Medicare program. The Secretary of the U.S. Department of Health and Human Services (Secretary) is authorized to promulgate regulations implementing those statutory provisions. Act § 1819 (42 U.S.C. § 1395i-3). These regulations are found at 42 C.F.R. pts. 483 and 488.

A SNF must maintain substantial compliance with program requirements to participate as a provider in the program. 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.

The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with the participation requirements. Act

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§ 1864(a) (42 U.S.C. § 1395aa(a)); 42 C.F.R. § 488.10. The Act also authorizes the Secretary to impose enforcement remedies against SNFs that do not comply with the participation requirements. Act § 1819(h)(2) (42 U.S.C. § 1395i-3(h)(2)). The regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance. 42 C.F.R. § 488.406. Among other enforcement remedies, CMS may impose a per-day CMP for the number of days a facility is out of substantial compliance or a per-instance CMP for each instance of noncompliance. 42 C.F.R. § 488.430(a).

CMS initially had authority to impose a per-instance CMP ranging from $1,000 to $10,000; that range is now adjusted annually for inflation. 42 C.F.R. § 488.430(a); 42 C.F.R. § 488.408(d)(1)(iv); 45 C.F.R. Part 102. In 2020, a per-instance CMP could range from $2,233 to $22,320. 85 Fed. Reg. 2869, 2886 (Jan. 17, 2020).

If CMS imposes a CMP against a facility based on a noncompliance determination, the facility may request a hearing before an Administrative Law Judge to determine whether there was a basis for the deficiency findings that led to the imposition of the remedy and whether the CMP imposed was reasonable. Act §§ 1128A(c)(2) (42 C.F.R. § 1320a-7a(c)(2)), 1819(h)(2)(B)(ii) (42 C.F.R. § 1395i(h)(2)(B)(ii)); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13). However, CMS’s choice of remedies and the factors it considered to decide upon remedies are not subject to review. 42 C.F.R. § 488.408(g)(2).

VII. Burdens of Proof and Persuasion

Congress established that in administrative adjudications covered by the Administrative Procedure Act, “the proponent of a rule or order has the burden of proof[,]” except where otherwise provided by statute. 5 U.S.C. § 556(d). The Act does not “otherwise provide[]” for allocation of the burden of proof or the quantum of evidence necessary to meet that burden in this type of proceeding. It would therefore be reasonable to conclude that CMS, the agency that propounded the regulations implementing its enforcement authority under the Act, bears the burden of proof and persuasion to justify imposition of penalties authorized by the Act.

Nevertheless, the Departmental Appeals Board has imposed a burden-shifting regime in cases involving the imposition of enforcement penalties against providers whose appeals are adjudicated under 42 C.F.R. Part 498. Hillman Rehab. Ctr., DAB No. 1611 (1997), aff’d, Hillman Rehab. Ctr. v. U.S. Dep’t of Health & Human Servs., No. Civ. A. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999); VITAS Healthcare Corp. of Cal., DAB No. 1782 at 4 (2001); Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004), aff’d sub nom., Batavia Nursing & Convalescent Ctr. v. Thompson, 143 F. App’x 664 (6th Cir. 2005).

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Under that regime, CMS has the burden to come forward with evidence sufficient to make a prima facie showing³ that it had a basis to impose a penalty. In Hillman, the Board identified the elements it believed necessary for CMS to make such a showing:

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

Hillman Rehab., DAB No. 1611 at 8.

Once CMS makes a prima facie showing of noncompliance, Petitioner bears the burden of persuasion and must prove by a preponderance of the evidence of record that it substantially complied with statutory and regulatory requirements. See Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004), aff’d sub nom., Batavia Nursing & Convalescent Ctr. v. Thompson, 143 F. App’x 664 (6th Cir. 2005).

To date, federal district and circuit courts have declined to reach the merits of the propriety of this burden-shifting regime. See, e.g., Hillman Rehab. Ctr., DAB No. 1611 (1997), aff’d, Hillman Rehab. Ctr. v. U.S. Dep’t of Health & Human Servs., No. Civ. A. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999); Fairfax Nursing Home, Inc., DAB No. 1794 (2001), aff’d, Fairfax Nursing Home v. Dep’t of Health & Human Servs., 300 F.3d 835 (7th Cir. 2002), cert. denied, 2003 WL 98478 (Jan. 13, 2003); Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004), aff’d sub nom., Batavia Nursing & Convalescent Ctr. v. Thompson, 143 F. App’x 664 (6th Cir. 2005).

The U.S. Supreme Court more recently examined the scope of the Secretary’s rulemaking authority in the context of Medicare reimbursement and held that under section 1871 of the Act, the Secretary must comply with notice-and-comment rulemaking under the Administrative Procedure Act to impose any requirements upon regulated entities which constituted a change in a substantive legal standard. Azar v. Allina Health Servs., 588 U.S. __, 139 S. Ct. 1804, 1809-14 (2019). It remains to be seen whether federal courts

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applying the Allina standard in reviewing the Board’s burden-shifting regime will find it constitutes a “change in a substantive legal standard” under the Allina holding or consider it a procedural mechanism within the Board’s delegated authority to impose as a reviewing body of ALJ decisions pertaining to CMS’s regulatory enforcement actions. Until such judicial scrutiny demands otherwise, and absent modification of the Act or CMS’s implementing regulations, I apply the Board’s burden-shifting regime.

VIII. Standard for Summary Judgment

Summary judgment is appropriate in cases where 42 C.F.R. Part 498 applies if there is no genuine dispute as to any material fact and the moving party is entitled to judgment as a matter of law. Crestview Parke Care Ctr. v. Thompson, 373 F.3d 743, 750 (6th Cir. 2004); Civ. Remedies Div. P. § 19(a). A “genuine” dispute exists if “the evidence is such that a reasonable [trier of fact] could return a verdict for the nonmoving party” (Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986)), and a “material” fact is one “that, if proven, would affect the outcome of the case under governing law.” Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300 at 3 (2010).

To obtain summary judgment, the moving party must show there is no genuine dispute of material fact requiring an evidentiary hearing and that it is entitled to judgment as a matter of law. Mission Hosp. Reg’l Med. Ctr., DAB No. 2459 at 5 (2012). If the moving party meets this initial burden, the non-moving party must “come forward with ‘specific facts showing that there is a genuine issue for trial.’” Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986); Senior Rehab., DAB No. 2300 at 3 (“To defeat an adequately supported summary judgment motion, the non-moving party may not rely on the denials in its pleadings or briefs, but must furnish evidence of a dispute concerning a material fact — a fact that, if proven, would affect the outcome of the case under governing law.”).

In evaluating a motion for summary judgment, an ALJ does not address credibility or evaluate the weight of conflicting evidence. Holy Cross Village at Notre Dame, Inc., DAB No. 2291 at 5 (2009). Rather, an ALJ must draw all reasonable inferences in the light most favorable to the non-moving party. See Brightview Care Ctr., DAB No. 2132 at 10 (2007) (upholding summary judgment where inferences and views of non-moving party are not reasonable); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249 (1986) (“[A]t the summary judgment stage the judge’s function is not . . . to weigh the evidence and determine the truth of the matter but to determine whether there is a genuine issue for trial.”). However, drawing factual inferences in the light most favorable to the non-moving party does not require me to accept the nonmoving party’s legal conclusions. Cedar Lake Nursing Home, DAB No. 2344 at 7 (2010).

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IX. Discussion

A. Legal framework for quality-of-care deficiencies

42 C.F.R. § 483.25 requires a SNF to provide each resident with “necessary care and services” to enable the resident to “attain or maintain the highest practicable physical, mental and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.”⁴ N. Las Vegas Care Ctr., DAB No. 2946 at 6 (2019). Consistent with this regulation, the Board has held that section 483.25 “implicitly imposes on [a SNF] a duty to provide care and services that, at a minimum, meet accepted professional standards of quality.” Id. (quoting Golden Living Ctr. – Foley, DAB No. 2510 at 23 (2013)).

A facility’s obligations under section 483.25 include furnishing the care and services set forth in its own resident care policies. Logan Healthcare Leasing, LLC, DAB No. 3036 at 14 (2021) (citing Life Care Ctr. of Bardstown, DAB No. 2479 at 22 (2012) (citations omitted), aff’d, 535 F. App’x 468 (6th Cir. 2013)); Good Shepherd Home for the Aged, Inc., DAB No. 2858 at 12 (2018).

CMS “may reasonably rely on a facility’s policy relating to the care and treatment of its residents as evidencing the facility’s understanding of what must be done to attain or maintain residents’ highest practicable physical, mental, and psychosocial well-being, as required by section 483.25.” N. Las Vegas Care, DAB No. 2946 at 6 (quoting The Laurels at Forest Glenn, DAB No. 2182 at 18 (2008)); see also Hanover Hill Health Care Ctr., DAB No. 2507 at 6 (2013) (observing “the Board has long held that a facility’s own policy may be sufficient evidence . . . of what the facility has determined is needed to meet the quality of care requirements in section 483.25”).

B. Undisputed Facts

Petitioner admitted Resident 1 (R1) on November 7, 2019 with diagnoses of Alzheimer’s disease, dementia, epilepsy, and unspecified convulsions. CMS Ex. 3 at 45-46; CMS Ex. 11 at 1-2. On November 16, 2019, R1’s physician prescribed Phenobarbital to control R1’s epileptic seizures. CMS Ex. 11 at 4. As of July 1, 2020, R1 received a 32.4 mg dose of Phenobarbital by mouth three times a day. Id. at 59. R1’s January 13, 2020 care plan required staff to “give medications as order[ed,] . . . [o]btain and monitor lab/diagnostic work as ordered[,] . . . [r]eport result to MD and follow up as indicated.” CMS Ex. 3 at 46; CMS Ex. 11 at 28. R1’s medication administration record for the

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month of August 2020 indicated he would receive doses of Phenobarbital at 8:00 a.m., 2:00 p.m., and 8:00 p.m. CMS Ex. 3 at 49.

From July 15 to August 14, 2020, drug control records for R1 indicated staff administered his Phenobarbital dose three times a day and that after giving him the last dose on August 14, 2020, “0” doses remained to administer. CMS Ex. 10 at 1-2. A refill request form from Petitioner to Omnicare, the pharmacy, reflects the facility requested a refill of Phenobarbital by facsimile on August 12, 2020, but that the pharmacy did not receive an order from R1’s physician authorizing the refill until August 19, 2020. CMS Ex. 9; CMS Ex. 12 at 3; CMS Ex. 3 at 59.

Medication Aide (MA) Anibal Guerrero confirmed he did not administer a dose of Phenobarbital to R1 on August 15, 2020, wrote a note requesting more Phenobarbital be ordered, and gave it to the charge nurse, Registered Nurse (RN) Jessica Charles, and Licensed Vocational Nurse (LVN) Theresa Bourgeois. CMS Ex. 3 at 51; P. Ex. 1 at 2. MA Guerrero did not follow up on the request or inform the Director of Nursing (DON) because he did not normally work in the East unit, where R1 resided. CMS Ex. 3 at 51. Nurse Charles could not recall a medication aide informing her the facility ran out of Phenobarbital for R1. CMS Ex. 3 at 51; CMS Ex. 8 at 11. Neither could she recall if she had informed either the Assistant Director of Nursing (ADON) or the DON of that fact. CMS Ex. 51 at 52; CMS Ex. 8 at 11.

On August 17, 2020, MA Neketra Weaver noted the lack of Phenobarbital to administer to R1 and notified LVN Michelle Busco, who MA Weaver claimed she witnessed calling the pharmacy to request a refill. CMS Ex. 3 at 53. MA Weaver acknowledged she did not notify either the ADON or DON on August 17, 2020, believing LVN Busco would do so. Id. LVN Busco confirmed she called the pharmacy and was told the pharmacy would deliver R1’s medication. Id. at 55.

On August 18, 2020, MA Patsy Hernandez could not administer Phenobarbital to R1 and informed LVN Busco there was no medication available to give the resident. Id. at 54. MA Beverly Johnson documented the lack of Phenobarbital available to administer on August 19, 20, and 21, 2020. Id. at 54-55. MA Johnson could not recall when the facility ran out of Phenobarbital to give R1, but confirmed she informed LVN Busco of that fact. Id. at 55.

On August 19 or 20, 2020,⁵ MA Johnson could not administer Phenobarbital to R1 and informed LVN Bourgeois there was no medication available to give the resident. CMS

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Ex. 3 at 56. LVN Bourgeois completed a form requesting that R1’s physician authorize a refill of Phenobarbital and faxed it to the physician’s office. CMS Ex. 3 at 56; CMS Ex. 12 at 3.

On a date she could not recall,⁶ LVN Busco called the pharmacy again and this time was told R1’s physician needed to issue a new prescription to refill R1’s Phenobarbital supply. Id. at 55. She then used an online system to request a prescription refill from R1’s physician. Id. LVN Busco explained the pharmacy communicated by e-mail with the facility’s nurse managers so she could not have known to obtain a new prescription without calling the pharmacy to ask why the medication had not been delivered. Id. at 56. LVN Busco acknowledged she did not inform the ADON or the DON that the facility’s supply of Phenobarbital for R1 had been depleted. CMS Ex. 3 at 56.

Between August 19 and August 21, 2020, R1 called his cousin⁷ several times to complain that he did not receive his medications. CMS Ex. 6 at 2, 10. R1’s cousin spoke with a facility nurse and a member of the business staff on August 20, 2020, and then again to the facility administrator on August 21, 2020, to ensure R1 received his medications. Id. at 10. R1’s cousin reported the administrator told her, after speaking with members of staff, that “residents get mixed up sometimes.” Id. 

The pharmacy delivered R1’s Phenobarbital to the facility on August 21, 2020, at approximately 2:30 p.m. CMS Ex. 3 at 56. R1 received his next dose of Phenobarbital on the evening of August 21, 2020. CMS Ex. 3 at 49, 56, 61; CMS Ex. 6 at 7 (“[P]henobarbital 32.4 mg was delivered on 8/21/2020 and one dose was administered on 8/21/2020 at 8P.M.”). August 22, 2020 laboratory results revealed R1’s Phenobarbital level was 6.8 ug/mL, lower than normal therapeutic levels of 15 to 40 ug/mL.⁸ CMS Ex. 3 at 48; CMS Ex. 11 at 36; CMS Ex. 16 at 2.

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On the morning of August 22, 2020, R1 experienced two seizures,⁹ each one lasting one and a half to two minutes and each one resulting in loss of consciousness. CMS Ex. 11 at 42. Petitioner’s staff notified R1’s cousin, who reported being told R1 had been unconscious for ten minutes after the first seizure. CMS Ex. 6 at 10. After the second seizure, R1’s cousin requested the facility transport R1 to the hospital for emergency care. CMS Ex. 6 at 10; CMS Ex. 11 at 42. Petitioner’s staff called for patient transport early that afternoon and an ambulance service transported R1 to the hospital at approximately 1:00 p.m. CMS Ex. 11 at 42.

In the complaint she filed with the state agency on August 28, 2020, R1’s cousin reported R1 had another seizure before reaching the hospital. CMS Ex. 6 at 10; CMS Ex. 8 at 2. She also claimed Petitioner failed to correctly transmit R1’s medication list by facsimile to the hospital, causing a delay in the administration of R1’s medication and resulting in a fourth seizure on August 22, 2020 at 7:20 p.m. Id.

R1’s Medication Administration Record from August 15, 2020 to August 21, 2020

Petitioner’s nursing staff documented the administration of medicine in each resident’s Medication Administration Record every shift. According to the legend at the bottom of R1’s Medication Administration Record, a check mark indicated a resident received medication. CMS Ex. 11 at 3. A code of “5” indicated “Hold/See Progress Notes,” which meant staff withheld medication from a resident and referred the reader to comments about the interaction (or lack thereof) in progress notes. Id.

The legend in this document does not indicate what a code of “9” means, but in the Statement of Deficiencies, the surveyor indicated “9” meant a medication was not administered to a resident due to lack of supply. CMS Ex. 3 at 49-50; see also CMS Ex. 8 at 4 (“9 stands for progress note . . . [n]umber 9 and progress note written in progress meant the medication was not given because the medication was out of supply.”).

From August 15, 2020, the day after R1’s chart indicated 0 tablets of Phenobarbital were left to administer, see CMS Ex. 10 at 2, to August 21, 2020, the day R1 received his next dose of Phenobarbital, see CMS Ex. 6 at 7, Petitioner documented administration of Phenobarbital to R1 as follows:

• August 15: medication administration scheduled at 8:00 a.m. and 2:00 p.m. coded “9,” 8:00 p.m. administration coded with a check mark;
• August 16: medication administration scheduled at 8:00 a.m. coded “9,” 2:00 p.m. and 8:00 p.m. administration coded with a check mark;

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• August 17: medication administration scheduled at 8:00 a.m. and 2:00 p.m. coded “5,” 8:00 p.m. administration coded “9;”
• August 18: medication administration scheduled at 8:00 a.m., 2:00 p.m., and 8:00 p.m. coded “9;”
• August 19: medication administration scheduled at 8:00 a.m. and 2:00 p.m. coded with a check mark, 8:00 p.m. administration coded “9;”
• August 20: medication administration scheduled at 8:00 a.m. and 2:00 p.m. coded “9,” 8:00 p.m. administration coded with a check mark;
• August 21: medication administration scheduled at 8:00 a.m. and 8:00 p.m. coded with a check mark, 2:00 p.m. administration coded “9.”

CMS Ex. 11 at 3.¹⁰

Facility medication ordering policy

Petitioner’s policy entitled “Medication Ordering: Operating and Monitoring System” required staff to communicate all medication orders to the pharmacy via facsimile and emphasized the pharmacy could not accept verbal orders. CMS Ex. 14 at 1. Staff could call the pharmacy after faxing an order if a medication was needed prior to the next scheduled delivery or to verify receipt of an order. Id. Petitioner’s policy also required nursing staff to audit each medication delivered against the medication ordered and document the date ordered, date received, and the identity of the member of staff taking receipt for each medication. Id.

Petitioner’s policy also required nursing staff to reorder medication when reduced to a five- to seven-day supply and confirm medication refills had been delivered to the facility when reduced to a three-day supply. Id. The policy obliged staff to immediately notify the Director of Nursing if any medication became unavailable. Id. It specified nurse managers were responsible for training staff on the medication ordering and reordering process, auditing reordering documentation daily, and auditing medication carts weekly to ensure availability of a three-day supply of any medication. Id. at 2.

C. Petitioner did not substantially comply with 42 C.F.R. § 483.25 (Tag F684) when it failed to provide R1 with his prescribed dose of Phenobarbital on 20 occasions from August 15 to August 21, 2020.

42 C.F.R. § 483.25 obligated Petitioner to ensure R1 received treatment and care in accordance with professional standards of practice, his care plan, and his choices. In this case, R1’s care plan included a physician’s order to administer Phenobarbital three times daily to manage his seizure disorder and to monitor R1 for side effects and effectiveness. CMS Ex. 11 at 3, 28, 40.

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There is no dispute that Petitioner did not administer Phenobarbital to R1 at the frequency ordered by his physician after its supply of the drug depleted August 14, 2020 until 8:00 p.m. on August 21, 2020.¹¹ CMS Ex. 8 at 7; CMS Ex. 10 at 1-2. CMS therefore contends Petitioner did not substantially comply with 42 C.F.R. § 483.25 by failing to follow its own Medication Ordering policy to obtain necessary medication,¹² which led to the facility’s failure to administer R1’s prescribed Phenobarbital as required by his care plan. CMS Br. at 8-9; CMS Ex. 3 at 45-59.

Petitioner nevertheless argues summary judgment is inappropriate because it in fact followed its Medication Ordering policy. P. Br. at 13. The facility explains its staff properly noted the imminent depletion of its supply of Phenobarbital and in compliance with its policy, notified the charge nurse, who faxed a refill order to the pharmacy. Id. (citing CMS Ex. 3 at 8, 10, 13; CMS Ex. 14). Petitioner points out that members of its staff took additional action to ensure the pharmacy refilled R1’s prescription, including reminders from medication aides to nurses and efforts by nurses to follow up with the pharmacy and, ultimately, contact R1’s physician. Id. (citing CMS Ex. 3 at 12-13, 51, 53-55; CMS Ex. 11 at 6-8; CMS Ex. 15 at 1-5, 7-9).

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Petitioner contends the delay in obtaining R1’s prescribed medication instead resulted from errors made by the pharmacy, namely its effort to notify Petitioner, via e-mail to an unmonitored e-mail address, that R1’s physician had to first authorize the Phenobarbital refill, when it should have contacted the physician directly for authorization. Id. (citing CMS Ex. 3 at 13; P. Ex. 2 at 1).

Petitioner therefore argues CMS failed to demonstrate the facility provided substandard quality of care, noting the record confirms other residents had no issues receiving medication as ordered, that its staff routinely monitored R1 during the period he did not receive Phenobarbital during which he showed no change in status, and that R1 later confirmed he suffered no lasting ill effects or change in his baseline condition as a result of the seizures. Id. at 13-14 (citing CMS Ex. 8 at 13-14; CMS Ex. 11 at 38-41, 42-46, 46-53); P. Ex. 3 at 1). As explained herein, Petitioner’s arguments are unpersuasive.

1. Petitioner failed to follow its Medication Ordering policy.

The undisputed evidence of record plainly rebuts Petitioner’s claim that its staff followed its Medication Ordering policy. That policy instructed nursing staff to reorder medications when reduced to a five- to seven-day supply and confirm delivery when reduced to a three-day supply. CMS Ex. 14 at 1. But the record shows Petitioner’s staff did not fax a refill request to the pharmacy until August 12, 2020, only two days before the facility ran out of Phenobarbital. CMS Ex. 9 at 1.

Even then, Petitioner’s staff took no notice that the pharmacy did not deliver R1’s Phenobarbital, thus failing to comply with the Medication Ordering policy’s requirement to ensure a requested medication refill was in the facility by the time it reduced to a three-day supply. CMS Ex. 3 at 59; CMS Ex. 14 at 1. When R1’s supply of Phenobarbital ran out on August 14, 2020, Petitioner’s staff failed to recognize the issue and take action for three days. On August 17, 2020, MA Weaver discovered there was no Phenobarbital to administer to R1 and notified LVN Busco, who MA Weaver claimed she witnessed calling the pharmacy to request a refill. CMS Ex. 3 at 53. However, Petitioner’s policy required staff to submit requests for medication by facsimile. CMS Ex. 14 at 1.

Despite being informed by medication aides on August 17 and August 18, 2020 that they had no Phenobarbital to administer to R1, LVN Busco did not follow up with the pharmacy until August 20, 2020, when she discovered the pharmacy required R1’s physician to authorize the refill order. CMS Ex. 3 at 55; CMS Ex. 8 at 13. Meanwhile, MA Guerrero wrote a note requesting more Phenobarbital be ordered on August 15, 2020, and gave it to Nurse Charles and LVN Bourgeois. CMS Ex. 3 at 51; P. Ex. 1 at 2. But Petitioner’s staff did not re-fax the request for a refill order of Phenobarbital to R1’s physician until the evening of August 19, 2020, and did not receive the Phenobarbital until August 21, 2020. CMS Ex. 3 at 53, 55; CMS Ex. 8 at 13; CMS Ex. 12 at 3.

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Petitioner’s staff also failed to comply with the facility’s policy to “immediately” notify the DON if a medication became unavailable.¹³ CMS Ex. 14 at 1. Nurse Charles, who was on duty August 15, 2020, could not recall if a medication aide had informed her that R1’s Phenobarbital supply ran out that day, or if she had informed either the ADON or the DON of that fact. CMS Ex. 8 at 11. MA Weaver acknowledged she did not notify either the ADON or DON on August 17, 2020, believing LVN Busco would do so. CMS Ex. 3 at 53. LVN Busco also acknowledged she did not inform the ADON or the DON. CMS Ex. 3 at 56. Both ADON Cabler and DON Smith confirmed facility staff had not informed them when R1’s Phenobarbital ran out. CMS Ex. 3 at 57; CMS Ex. 8 at 11.

Petitioner’s nurse managers themselves failed to comply with the policy’s obligation to audit reordering documentation daily and audit medication carts weekly to ensure a minimum 3-day supply of any necessary medication. CMS Ex. 14 at 1. ADON Cabler admitted she did not audit the medication cart in the East unit where R1 stayed or check the re-order form faxed to the pharmacy to ensure the facility had requested refills for necessary medications. CMS Ex. 3 at 58; CMS Ex. 8 at 16 (“I missed it.”). DON Smith acknowledged she had not reviewed shift reports that would have alerted her to the unavailability of Phenobarbital for R1 from August 17, 2020 to August 19, 2020. Id. DON Smith also confirmed she only audited medication carts every other week, not weekly. CMS Ex. 8 at 17.

In short, the record is replete with examples of various ways Petitioner’s staff, from its Medication Aides to its nurses and nurse managers, failed to follow the facility’s Medication Ordering policy. Petitioner’s claim that it complied with its own policy is starkly at odds with the undisputed evidence of record.

2. Petitioner bore the responsibility to ensure R1 received his medication.

Petitioner next attempts to blame the pharmacy for the delay in obtaining R1’s refill of Phenobarbital, noting that facility staff faxed the refill order on August 12, 2020, before its supply was depleted.¹⁴ P. Br. at 13. Petitioner explains the pharmacy delayed

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dispensing that order when it improperly sought to notify Petitioner of the need for a refill authorization from R1’s physician by sending notice to an unmonitored e-mail address. Id. Petitioner states the pharmacy made no effort to obtain that authorization, despite contacting the physician’s office on August 17, 2020 on another matter. Id.

This argument is without merit as it is premised on the notion that either the pharmacy or R1’s physician bore the primary obligation to ensure facility residents received their medications. That notion is incorrect. 42 C.F.R. § 483.25 requires facilities like Petitioner to “ensure that residents receive treatment and care.” (Emphasis added.) And it is clear Petitioner understood itself to bear that obligation. Its Medication Ordering policy sets forth as its goal “[t]o ensure all medications, pursuant to a valid physician order, are available in the facility at all times.” CMS Ex. 14 at 1. That policy specifically requires nursing staff to “call [the] pharmacy if any [medication] order was not delivered.” Id.

DON Smith acknowledged to Surveyor Nguyen that staff were obligated to immediately contact the pharmacy if a medication was unavailable to ensure its delivery. CMS Ex. 3 at 63. ADON Cabler confirmed staff were required to inform the charge nurse if a medication was out of supply, obligating the charge nurse to call the pharmacy to make sure of delivery, document non-delivery if the medication was not received by the next day, and inform the ADON or DON. Id. at 61-62. In short, had Petitioner’s staff followed its policy concerning reordering medication, particularly those out of supply, it would not have been possible for any alleged error committed by the pharmacy or R1’s physician to prevent delivery of R1’s medication.

3. Petitioner’s failure to provide R1 medication as ordered by his physician for six consecutive days posed a risk of more than minimal harm.

The remainder of Petitioner’s arguments – that other residents had no issues receiving medications, that its staff routinely monitored R1 during the period he went without Phenobarbital to ensure his well-being, and that subsequent medical examination and R1’s own testimony confirm he suffered no harm from the six days he went without the medication – are essentially variations of its claim that CMS failed to demonstrate that it provided substandard quality of care. P. Br. at 13-14. They are equally without merit.

Petitioner’s observation that other facility residents received their medications without issue is irrelevant. A deficiency assigned a “J” level of scope and severity refers to an isolated instance of substandard care that constitutes immediate jeopardy to resident health and safety. State Operations Manual, Rev. 185, Ch. 7, § 7400.3.1. Had other

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residents experienced difficulty receiving medications arising from the failure of Petitioner’s staff to follow its Medication Ordering policy, it is likely CMS would have assigned the deficiency at issue here a higher level of scope, if not severity.

Petitioner’s claims R1 suffered no harm because its staff monitored him¹⁵ during the period he was not receiving Phenobarbital and because subsequent testing along with R1’s own assessment confirmed he had no persistent issues are equally irrelevant for the same reason.¹⁶ To impose a remedy, CMS did not have to show R1 suffered actual harm, as Petitioner appears to believe. CMS only needed to show that Petitioner was not in substantial compliance with the requirements of participation such that the identified deficiency posed a risk to resident health or safety of no more than “the potential for causing minimal harm.” 42 C.F.R. § 488.301; see also Libertyville Manor Rehab. & Healthcare Ctr., DAB No. 2849 at 17 (2018) (“[T]he absence of actual harm does not invalidate the noncompliance finding because, under the governing regulations, a SNF is considered to be out of substantial compliance if the deficiency either results in actual harm to a resident or poses a risk of more than minimal harm to resident health or safety.”).¹⁷

The potential for more than minimal harm to R1 is beyond dispute. It would be absurd to argue that failing to provide a resident medication ordered by his physician to help control a seizure disorder for six days would not pose a risk of more than minimal harm. That R1 suffered several seizures shortly thereafter does not help Petitioner’s case.

Petitioner has failed to prove a genuine dispute of material fact exists with respect to its regulatory obligation to ensure that R1 received treatment and care in accordance with

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professional standards of practice, his care plan, and his choices. Petitioner bore the primary burden of ensuring R1 received medications ordered by his physician and set forth in his care plan. Yet it did not provide R1 his prescribed Phenobarbital for six consecutive days, from 8:00 a.m. on August 15, 2020 to 8:00 p.m. on the evening of August 21, 2020. The facility’s failure to do so stemmed from the almost total noncompliance by its staff with the facility’s Medication Ordering policy, compliance with which would have vastly improved R1’s odds of receiving his medication. This failure posed a risk of more than minimal harm to R1’s health and safety. As a result, I find Petitioner failed to substantially comply with the requirements of 42 C.F.R. § 483.25 (Tag F684).

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

Petitioner argues that even assuming its substantial noncompliance, a genuine issue of material fact exists as to whether that noncompliance rose to the level of actual harm and/or immediate jeopardy. P. Br. at 11-12. Petitioner relies on the absence of abnormal conditions in R1’s progress notes on August 17, 2020 and August 20, 2020 to assert that R1 did not have recent seizures and was not in distress or imminent danger during the period he did not receive Phenobarbital. Id. Petitioner believes this evidence contradicts CMS’s finding of immediate jeopardy and thus precludes summary judgment. Id.

But the lack of documented abnormalities during the period Petitioner stopped administering Phenobarbital does not establish R1 did not suffer negative consequences from Petitioner’s substantial noncompliance. Petitioner omits the fact that after R1 went six days without receiving his prescribed medication, he had at least two seizures and went to the hospital.

In any event, I need not consider the merits of Petitioner’s argument as I cannot review CMS’s determination of immediate jeopardy. A facility may challenge CMS’s determination of the scope and severity of noncompliance only if a successful challenge would affect the range of the CMP that may be imposed or impact the facility’s authority to conduct a nurse aide training program. 42 C.F.R. § 498.3(b)(14), (d)(10)(i). Petitioner has not asserted it had a nurse aide training program when CMS issued its notice of noncompliance. CMS imposed a per-instance CMP for the noncompliance cited at the immediate jeopardy level. There is only one range for per-instance CMPs. 42 C.F.R. § 488.845(b)(6). Overturning the immediate jeopardy finding would have no effect on the range of the CMP issued, therefore making CMS’s immediate jeopardy determination unreviewable. NMS Healthcare of Hagerstown, DAB No. 2603 at 6-7 (2014) (“The level of noncompliance may be appealed, and reviewed, only if a successful challenge would affect the range of the CMP amounts that CMS could collect or affect a finding of substandard quality of care that resulted in the loss of a nurse aide training program.”) (citing 42 C.F.R. § 498.3(b)(14), (d)(10)(i)-(ii)).

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E. The $20,780 per-instance CMP imposed by CMS is reasonable.

Petitioner contends the reasonableness of the penalty imposed by CMS is a triable issue of fact precluding summary judgment. P. Br. at 11. This is incorrect. The reasonableness of a CMP is a legal issue, not a factual one.¹⁸ Crawford Healthcare & Rehab., DAB No. 2738 at 18-19 (2016) (citing Cedar Lake Nursing Home, DAB No. 2344 at 12 (2010)).

Here, CMS imposed a per-instance CMP of $20,780. In 2020, a per-instance CMP could range from $2,233 to $22,320. 86 Fed. Reg. 62,938. In determining the reasonableness of the penalty amount imposed by CMS, I look to the factors set forth at 42 C.F.R. §§ 488.438(f) and 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)). These factors include the seriousness of the deficiency and the facility’s compliance history, financial condition, and degree of culpability. Id.

Considering the seriousness of Petitioner’s noncompliance, I find it significant.¹⁹ Petitioner does not dispute that it did not administer 20 doses of Phenobarbital to R1 from August 15, 2020 to the evening of August 21, 2020. CMS Ex. 3 at 45-60. Petitioner similarly does not dispute that prior to his transfer to the hospital, R1 suffered two seizures at the facility on August 22, 2020. P. Br. at 11; CMS Ex. 3 at 46-49. Petitioner does dispute whether its substantial noncompliance in fact caused R1 to suffer the seizures he experienced on August 22, 2020. Because I decide this matter on summary judgment, I will not draw a negative inference, no matter how obvious, to conclude Petitioner’s failure to ensure R1 received one of the three medications prescribed to prevent seizures for six days caused him to experience at least two seizures the next day. Instead, it is sufficient to note that Petitioner’s failure to provide anti-seizure medications for six days to a resident with a seizure disorder needlessly subjected R1 to at least the potential for serious risk of harm from seizures.

The seriousness of Petitioner’s noncompliance is difficult to overstate given that it resulted from a nearly universal failure on the part of Petitioner’s staff to follow its own policy. As outlined supra at section C.1, nearly every single employee from the medication aides to the nurses on duty who knew R1’s Phenobarbital was dwindling or gone but failed to follow some aspect of the procedure set by the facility to ensure no resident went without necessary medications. Non-managerial employees universally

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failed to notify the DON or ADON, as the facility’s policy required. The nurse managers also failed to follow aspects of the policy that would have alerted them to the issue even when their employees had not. A systemic failure of this magnitude cannot be seen as anything but significant. The seriousness of Petitioner’s substantial noncompliance amply supports the upper-range per-instance CMP amount selected by CMS.

Petitioner’s history of noncompliance shows the facility was found noncompliant in six survey cycles resulting in two enforcement actions, including the one at issue. CMS Ex. 16 at 2. CMS notes that Petitioner’s noncompliance history includes multiple immediate jeopardy deficiencies for failures to develop and implement policies to prevent neglect of residents. CMS Br. at 11. Petitioner does not dispute CMS’s characterization of its history of noncompliance. Petitioner’s history of noncompliance with health and safety requirements supports the upper-range per-instance CMP imposed by CMS in this case.

Petitioner has provided no evidence of its financial condition. I have therefore not considered this factor in my evaluation.

Turning to culpability, while Petitioner did not intend to neglect or disregard R1, the failure of its staff to follow its Medication Ordering policy suggests a lack of concern or ignorance, either of which militates towards a higher penalty. Equally significant is Petitioner’s effort in litigation before me to blame other entities for its mistakes. Neither the pharmacy nor R1’s physician is ultimately culpable for Petitioner’s failure to ensure R1 received necessary medication for six days.

A high degree of culpability is also apparent from Petitioner’s attitude concerning R1’s risk of seizures. After he did not receive Phenobarbital for several days, R1 contacted his cousin to complain. R1’s cousin, who had authority to make medical decisions for him, made numerous efforts to notify Petitioner’s management of the issue. On August 20, 2020, she spoke with Nurse Charles and a member of the facility’s business staff. CMS Ex. 6 at 10. On August 21, 2020, after R1 complained again, R1’s cousin spoke with the Administrator, who by report claimed she spoke with members of staff and said “residents get mixed up sometimes.”²⁰ Id. The next day, August 22, 2020, Nurse Charles called R1’s cousin to report he had experienced two seizures. Id. 

Petitioner now claims these seizures “only” lasted one and a half to two minutes, and that R1 had no lasting damage from the seizures he suffered that day. P. Br. at 11, 14. But as described by Petitioner’s nursing staff, R1’s seizures were not mild events:

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Resident was in [a] wheel[ ]chair in dining room waiting for breakfast when he let out a yell and dropped his cup of coffee on the floor. [Staff] ran over to the resident and found him having convulsions in his wheel[ ]chair. Seizure lasted approx. 2 minutes at which point resident turned pale white and lips cyanotic and then lost consciousness. [R1] was having increased respirations.

CMS Ex. 11 at 42.

The fact that R1 had no lasting harm from the seizures he suffered on August 22, 2020 does not give Petitioner license to minimize their significance, whether the facility’s noncompliance directly caused them or not. I find Petitioner’s culpability supports the CMP selected by CMS.

Given the seriousness of the deficiency, Petitioner’s history of noncompliance, its culpability, and the absence of evidence suggesting an inability to pay, I conclude the $20,780 per-instance CMP selected by CMS is reasonable.

X. Conclusion

Petitioner failed to meet its regulatory obligation to ensure R1 received treatment and care in accordance with professional standards of practice, his care plan, and his choices, and was therefore not in substantial compliance with 42 C.F.R. § 483.25. There is no genuine dispute of material fact concerning the bases for the cited deficiency, namely Petitioner’s failure to provide 20 prescribed doses of Phenobarbital to R1 for six days and the failure of Petitioner’s staff to comply with its Medication Ordering policy. CMS’s immediate jeopardy determination is not reviewable. Based on my analysis of the appropriate regulatory factors in light of the parties’ arguments and submissions, the $20,780 per-instance CMP selected by CMS is reasonable. For these reasons, I grant summary judgment in favor of CMS.

Endnotes

¹ Scope and severity levels, designated by letters “A” through “L,” derive from the scope and severity matrix published by CMS in its State Operations Manual (SOM), the agency’s published guidance for surveyors of long-term care facilities. Ctrs. for Medicare & Medicaid Servs., Pub. 100-07, State Operations Manual Rev. 185, Ch. 7, § 7400.3.1 (eff. Nov. 16, 2018), available at https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads…. Facilities with deficiencies of levels A, B, or C remain in substantial compliance. Id. Levels D, E, or F indicate a deficiency that presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy. Id. Levels G, H, or I indicate a deficiency that involves actual harm that does not amount to immediate jeopardy. Id. Scope and severity levels J, K, and L contain deficiencies that constitute immediate jeopardy to resident health or safety. Id. The matrix specifies which remedies are required and optional at each level based upon the pervasiveness of the deficiency (isolated, pattern, or widespread). Id.

² Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993), requires judges to scrutinize expert testimony by assessing the methodology and reasoning behind opinion evidence before permitting its consideration by a jury. The holdings from Daubert and successor cases clarifying the Daubert standard have been incorporated into F.R.E. 702, the framework Petitioner presumably wishes to be applied here.

³ The Board has not specified the quantum of evidence necessary for CMS to show that it met its prima facie burden, but has observed CMS must produce “evidence related to disputed findings that is sufficient (together with any undisputed findings and relevant legal authority) to establish a prima facie case of noncompliance with a regulatory requirement.” Evergreene Nursing Care Ctr., DAB No. 2069 at 7 (2007); see also Black’s Law Dict. at 1228 (8th ed. 2004) (“Prima facie” means generally that the evidence is ‘[s]ufficient to establish a fact or raise a presumption unless disproved or rebutted’”).

⁴ CMS revised part 483 regulations concerning SNF conditions of participation in 2016, including the introductory language of the quality-of-care regulation found at 42 C.F.R. § 483.25. 81 Fed. Reg. 68,688 (Oct. 4, 2016); 82 Fed. Reg. 32,256 (Jul. 13, 2017) (technical corrections). Because this revision did not significantly change the regulatory requirements, Board cases discussing the quality-of-care regulation prior to its 2016 amendment are still relevant.

⁵ LVN Bourgeois reported to Surveyor Nguyen this event occurred on August 20, 2020, see CMS Ex. 3 at 56, but the record suggests it more likely took place on August 19, 2020. LVN Bourgeois stated she faxed the online request to R1’s physician to refill his Phenobarbital prescription on the same day she learned that medication had run out. CMS Ex. 3 at 56. That refill request is part of the record and shows she transmitted it on August 19, 2020 at approximately 6:00 p.m. CMS Ex. 12 at 3.

⁶ This most likely occurred on August 20, 2020. LVN Busco reported making a second call to the pharmacy and submitting an online reorder request to R1’s physician the same day. CMS Ex. 8 at 12-13. She also recalled that LVN Bourgeois had faxed the reorder request to R1’s physician the night before. Id. at 13. That refill request is dated August 19, 2020. CMS Ex. 12 at 3.

⁷ R1’s cousin had power of attorney to make healthcare decisions for him. CMS Ex. 6 at 10; CMS Ex. 11 at 42.

⁸ Phenobarbital level measures drug concentration in a resident’s blood; levels “of 10-35 ug/mL are recommended for seizure management.” CMS Ex. 16 at 2 (Declaration of Nurse Consultant Susana Cruz), citing Suzanne Bentley, MD, MPH, FACEP, CHSE, Phenobarbital Level, Medscape, available athttps://emedicine.medscape.com/article/2090284-overview#a2?form=fpf (last rev. Sep. 24, 2020)). Petitioner objects to CMS’s reliance on this article, P. Obj. at 2-3, but does not contest the accuracy of this statement. I therefore have no basis to reject Nurse Cruz’s reliance on Dr. Bentley’s opinion as to what constitutes a therapeutic level of Phenobarbital.

⁹ Petitioner claims there is a factual dispute as to the total number of seizures suffered by R1. P. Br. at 11. Even if this were true, it is not a material dispute. The deficiency finding here is not based on the fact that R1 suffered seizures, but on the failure of Petitioner’s staff to follow its policy concerning medication ordering such that R1 did not receive medication for several days.

¹⁰ As explained infra at n. 11, this documentation is inaccurate. R1 did not actually receive his medication at the times and dates indicated.

¹¹ Petitioner’s staff recorded sporadic administration of Phenobarbital to R1 in his Medication Administration Record on several occasions between August 15, 2020 and August 21, 2020. CMS Ex. 11 at 3. However, the two Medication Aides who documented those instances admitted to Surveyor Nguyen that their documentation was erroneous and in fact gave no Phenobarbital to R1 at all during this period. Compare CMS Ex. 11 at 3, with CMS Ex. 3 at 51-53, CMS Ex. 8 at 4-6. Petitioner does not contest their hearsay admissions. Had it done so, I note the amount of Phenobarbital purportedly administered to R1 during that period falls far short of the dosage ordered by R1’s physician to be administered three times daily. See CMS Ex. 11 at 3 (documenting administration of Phenobarbital to R1 once on August 15, 2020, twice on August 16, 2020, twice on August 19, 2020, and once on August 20, 2020). Thus, even if R1’s Medication Administration Record was accurate, it would still establish Petitioner’s failure to provide medication consistent with its Medication Ordering policy and therefore its obligations under 42 C.F.R. § 483.25.

¹² Excluding legal boilerplate, the entirety of CMS’s argument takes up less than one page. CMS Br. at 8-9. CMS makes no effort at all to cite the record to support its assertion that “the facility failed to re-order R1’s medications when down to 5 to 7 days of supply, to confirm that the refill was in the facility when down to a 3-day supply, to notify the DON immediately when R1’s Phenobarbital was unavailable on 20 consecutive occasions, and Nurse management failed to audit the re-order book and medication cart.” Id. It should go without saying that it is insufficient for counsel to make bald assertions and leave me to scour the record to verify those assertions. See, e.g., U.S. v. Dunkel, 927 F.2d 955, 956 (7th Cir. 1991) (“Judges are not like pigs, hunting for truffles buried in briefs.”); see also Tex. Disciplinary R. Prof. Conduct, R. 1.01, Comment 6 (last rev. Jan. 31, 2022), available at https://www.texasbar.com/tdrpc/ (“[A] lawyer should act with competence, commitment and dedication to the interest of the client and with zeal in advocacy upon the client’s behalf. A lawyer should feel a moral or professional obligation to pursue a matter on behalf of a client with reasonable diligence and promptness despite opposition, obstruction or personal inconvenience to the lawyer.).”

¹³ Petitioner briefly asserts it did not matter whether the DON or ADON knew the status of the order for R1’s Phenobarbital because its staff were already acting “prudently and in accordance with professional practice” to obtain the medication. P. Br. at 13. Putting aside the fact that this position flatly contravenes the facility’s own policy requiring notification of the DON when a medication became unavailable, Petitioner’s claim is erroneous. DON Smith made clear that had she been informed of the lack of Phenobarbital for R1, she could have ordered the medication from a different pharmacy on an emergent basis to obtain two to three days’ supply. CMS Ex. 3 at 57.

¹⁴ Petitioner also lays blame at the feet of R1’s physician, noting that a physician’s exclusive power to write prescriptions precludes facility noncompliance for delay caused by a physician. P. Br. at 12. Petitioner does not explain how R1’s physician could have caused the delay in obtaining Phenobarbital for R1 by failing to authorize a refill where there is no evidence Petitioner requested a refill order from R1’s physician any earlier than August 19, 2020, five days after R1’s last dose. CMS Ex. 12 at 3. I decline to speculate as to the basis of Petitioner’s contention.

¹⁵ Petitioner also points to the fact that treating Nurse Practitioner Theresa Lyons saw R1 on August 17 and August 20, 2020, and found him in “status quo.” P. Br. at 14 (citing CMS Ex. 11 at 38-41, 42-46). Petitioner appears to contend NP Lyons validated its claim that R1 suffered no harm from being deprived of Phenobarbital, but the clinical records cited by Petitioner do not suggest NP Lyons was even aware the facility had stopped giving R1 Phenobarbital as of August 15, 2020. See CMS Ex. 11 at 38 (NP Lyon’s documentation of her August 17, 2020 visit with R1, noting he was “[s]table without any recent seizures on dilantin, phenobarbital, and carbamazepine”); CMS Ex. 11 at 41 (NP Lyons’ characterization of R1 as stable on the same three medications and relying on July 2020 laboratory results). There is no reasonable basis to conclude NP Lyons knew R1 was not receiving Phenobarbital on the days she saw him and nevertheless concluded he was “stable.”

¹⁶ Petitioner relatedly speculates as to other reasons why R1 had sub-therapeutic levels of the three medications he took to claim the seizures he experienced on August 22, 2020 were not solely caused by its failure to timely provide him Phenobarbital as ordered by his physician. P. Br. at 14. The ultimate cause of R1’s seizures is irrelevant. Petitioner’s failure to follow its own policy and ensure R1 received his medications was sufficient to cause the potential for more than minimal harm and therefore a valid basis to find a deficiency.

¹⁷ A finding of immediate jeopardy requires CMS to meet a higher burden, which I discuss infra at section D.

¹⁸ It is possible to defeat summary judgment as to the reasonableness of the penalty if there is a genuine factual dispute that would affect my assessment of the relevant regulatory factors. Crawford, DAB No. 2738 at 19. Petitioner has identified no such genuine factual dispute here.

¹⁹ While I would normally consider CMS’s finding of immediate jeopardy as part of my assessment of the seriousness of the deficiency, for the purposes of summary judgment I have not done so here. I assess the seriousness of Petitioner’s substantial noncompliance based solely on the undisputed evidence of record set forth in this decision.

²⁰ The Administrator submitted a declaration in this matter but did not contradict this characterization. P. Ex. 1.