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# All Saints Healthcare Subacute, DAB CR6215 (2023)

----

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

## All Saints Healthcare Subacute,(CCN: 056407),Petitioner,

## v.

## Centers For Medicare & Medicaid Services.

### Docket No. C-19-331Decision No. CR6215January 12, 2023

### DECISION

Petitioner, All Saints Healthcare Subacute, did not violate 42 C.F.R. § 483.45(c)(3) or (e)(1) through (3)1 as alleged by the Centers for Medicare & Medicaid Services (CMS).  Petitioner violated 42 C.F.R. § 483.45(e)(4) and (5) but the violations did not pose a risk for more than minimal harm and did not amount to noncompliance.  There is no basis for imposing an enforcement remedy.

### I.  Background

Petitioner is in North Hollywood, California, and participates in Medicare as a skilled nursing facility (SNF) and the state Medicaid program as a nursing facility (NF).  The

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California Department of Public Health (state agency) completed a complaint investigation and recertification survey of Petitioner on August 10, 2018.  The state agency surveyors concluded that Petitioner was not in substantial compliance with program participation requirements due to thirteen regulatory violations that posed a risk for more than minimal harm.  CMS Exhibits (Exs.) 1-2; Joint Stipulation of Undisputed Facts (Jt. Stip.) ¶¶ 1‐2.  CMS subsequently found that Petitioner returned to substantial compliance with program participation requirements effective October 18, 2018.  Jt. Stip. ¶ 4.

CMS notified Petitioner by letter dated November 28, 2018, that based only upon the alleged violations of 42 C.F.R. § 483.45(c)(3) and (e)(1) through (5) (Tag F758)2 CMS was imposing a per‐instance civil monetary penalty (PICMP) of $10,000.  Jt. Stip. ¶ 3; CMS Ex. 2 at 2.

Petitioner requested a hearing before an administrative law judge (ALJ) on January 10, 2019 (RFH).  The case was assigned to me for hearing and decision on January 22, 2019, and an Acknowledgment and Prehearing Order was issued at my direction.

On November 3 and 4, 2020, a hearing was convened by video teleconference and a transcript (Tr.) of the proceedings was prepared.  CMS offered CMS Exs. 1 through 37 that were admitted as evidence.  Tr. 26‐29.  Petitioner offered Petitioner’s exhibits (P. Exs.) A through C that were admitted as evidence.  Tr. 29‐30.  During the hearing, Petitioner requested leave to submit additional exhibits.  Tr. 30-36.  Petitioner filed P. Exs. D through F on November 3, 2020, and P. Exs. G through K on November 4, 2020.  On November 24, 2020, CMS waived objections to my consideration of P Exs. D through K.  On December 7, 2020, Petitioner filed substituted copies of P. Exs. D through K and moved to admit those exhibits.  On December 8, 2020, I issued a ruling granting Petitioner’s motion and admitted P. Exs. D through K.

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In accordance with my November 4, 2020 order from the bench during the hearing (Tr. 468), CMS filed a motion offering CMS Ex. 38 on November 6, 2020.  On November 13, 2020, CMS filed an unopposed motion to withdraw CMS Ex. 38 and offered CMS Ex. 39.  CMS Ex. 39 is admitted as evidence.

CMS called the following witnesses to testify at the hearing:  Surveyor Linda Ekeomodi, who, according to her resume, has a Bachelor of Science degree in pharmacy and is licensed as a pharmacist in California with prior pharmacist licenses in Nebraska and Maryland (CMS Ex. 3); and Surveyor Leilani Joy Abucay-Soller, RN, BSN (CMS Ex. 4).  Petitioner called the following witnesses:  Pamela Rupp, RN, MSN, who holds a certification as a public health nurse and a nursing home administrator’s license and was Petitioner’s Vice President of Operations (P. Ex. B); and Ilanit Brook, MD, MSHS (P. Ex. C).

Following the hearing, the parties filed post-hearing briefs (CMS Br. and P. Br., respectively) and post-hearing replies (CMS Reply and P. Reply, respectively).

### II.  Discussion

**A.  Applicable Law**

**1.  Statutory and Regulatory Medicare Program Enforcement**

The statutory and regulatory requirements for participation of a SNF in Medicare are at section 1819 of the Social Security Act (Act) and 42 C.F.R. pt. 483.  Section 1819(h)(2) of the Act authorizes the Secretary (the Secretary) of Health and Human Services (HHS) to impose enforcement remedies against a SNF for failure to comply substantially with the federal participation requirements established by sections 1819(b), (c), and (d) of the Act.3  The Act requires that the Secretary terminate the Medicare participation of any SNF that does not return to substantial compliance with participation requirements within six months of being found not to be in substantial compliance.  Act § 1819(h)(2)(C).  The Act also requires that the Secretary deny payment of Medicare benefits for any beneficiary admitted to a SNF if the SNF fails to return to substantial compliance with program participation requirements within three months of being found not to be in

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substantial compliance – commonly referred to as the mandatory or statutory denial of payments for new admissions (DPNA).  Act § 1819(h)(2)(D).  The Act grants the Secretary discretionary authority to terminate a noncompliant SNF’s participation in Medicare, even if there has been less than six months of noncompliance.  The Act also grants the Secretary authority to impose other enforcement remedies, including a discretionary DPNA, civil money penalties (CMP), appointment of temporary management, and a directed plan of correction.  Act § 1819(h)(2)(B).

The Secretary has delegated to CMS and the states the authority to impose remedies against a SNF or NF that is not in substantial compliance with federal participation requirements.  42 C.F.R. §§ 488.400, 488.402(b).  "*Substantial compliance*means a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm."  42 C.F.R. § 488.301 (emphasis in original).  A deficiency is a violation of a participation requirement established by sections 1819(b), (c), and (d) of the Act or the Secretary’s regulations at 42 C.F.R. pt. 483, subpt. B.  42 C.F.R. § 488.301.  The term "noncompliance" refers to any deficiency (statutory or regulatory violation) that causes a facility not to be in substantial compliance; that is, a deficiency that poses a risk for more than minimal harm.  42 C.F.R. § 488.301.  Therefore, even if a facility violates a statutory or regulatory requirement, CMS may not impose enforcement remedies if the deficiency does not pose a risk for more than minimal harm.

State survey agencies survey facilities that participate in Medicare on behalf of CMS to determine whether the facilities are complying with federal participation requirements.  42 C.F.R. §§ 488.10‐.28, 488.300-.335.  The regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance with Medicare requirements.  42 C.F.R. § 488.406.

CMS is authorized to impose a CMP against a facility not in substantial compliance with program participation requirements.  CMS is authorized to impose a CMP on a per day or per instance basis.  In this case, CMS proposed a PICMP.  CMS is authorized to impose a PICMP in the range of $2,097 to $20,965.  42 C.F.R. §§ 488.408(d), (e); 488.438(a)(2); 45 C.F.R. § 102.3 (Table) (2017).

The Act and regulations make a hearing before an ALJ available to a SNF against which CMS has determined to impose an enforcement remedy.  Act §§ 1128A(c)(2), 1866(h); 42 C.F.R. §§ 488.408(g), 498.3(b)(13).  A facility has a right to appeal a "certification of noncompliance leading to an enforcement remedy."  42 C.F.R. §§ 488.408(g)(1); 488.330(e), 498.3(b)(13).  However, the choice of remedies, or the factors CMS considered when choosing remedies, are not subject to review.  42 C.F.R. § 488.408(g)(2).  A facility may only challenge the scope and severity level of noncompliance determined by CMS if a successful challenge would affect the range of the CMP that may be imposed or impact the facility’s authority to conduct a NATCEP.

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42 C.F.R. § 498.3(b)(14), (d)(10)(i).  The CMS determination as to the level of noncompliance, including the finding of immediate jeopardy, "must be upheld unless it is clearly erroneous."  42 C.F.R. § 498.60(c)(2); *Woodstock Care Ctr.*, DAB No. 1726 at 9, 39 (2000), *aff’d*, *Woodstock Care Ctr. v. Thompson*, 363 F.3d 583 (6th Cir. 2003).  The Board has long held that the net effect of the regulations is that a provider has no right to challenge the scope and severity level assigned to a noncompliance finding, except in the situation where that finding was the basis for an immediate jeopardy determination.  *See, e.g*., *Ridge Terrace*, DAB No. 1834 (2002); *Koester Pavilion*, DAB No. 1750 (2000).  ALJ review of a CMP is subject to 42 C.F.R. § 488.438(e).

**2.  Burden of Proof, Burden of Production, and Quantum of Evidence**

The hearing before an ALJ is a de novo proceeding, that is, "a fresh look by a neutral decision-maker at the legal and factual basis for the deficiency findings underlying the remedies."  *Life Care Ctr. of Bardstown*, DAB No. 2479 at 33 (2012) (citation omitted).

The allocation of the burden of proof and the quantum of evidence required to meet the burden is not addressed by regulations applicable in this case.4  Rather, the Board has long held that the petitioner, i.e., the nongovernmental party affected by CMS action imposing and enforcement remedy, bears the ultimate burden of persuasion to show by a

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preponderance of the evidence that it was in substantial compliance with participation requirements or any affirmative defense.  *Batavia Nursing & Convalescent Inn*, DAB No. 1911 (2004); *Batavia Nursing & Convalescent Ctr.*, DAB No. 1904 (2004), *aff’d*, *Batavia Nursing & Convalescent Ctr. v. Thompson*, 129 F. App’x 181 (6th Cir. 2005); *Emerald Oaks*, DAB No. 1800 (2001); *Cross Creek Health Care Ctr.*, DAB No. 1665 (1998); *Hillman Rehab. Ctr.*, DAB No. 1611 (1997) (remand to ALJ), DAB No. 1663 (1998) (after remand), *aff’d*, *Hillman Rehab. Ctr. v. United States*, No. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999).  The Board has indicated that CMS has the initial burden of production to make a prima facie showing of noncompliance.  If CMS makes a prima facie showing, then the facility bears the burden to show, by a preponderance of the evidence on the record as a whole, that it was in substantial compliance or had an affirmative defense.  *Evergreene Nursing Care Ctr.*, DAB No. 2069 at 7 (2007).  The Board has not clearly defined the quantum of evidence CMS needs to present to meet its burden of making a prima facie showing.  The Board has stated that CMS must come forward with "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."  *Id.*; *Batavia Nursing & Convalescent Ctr.*, DAB No. 1904.  "Prima facie" means generally that the evidence is "[s]ufficient to establish a fact or raise a presumption unless disproved or rebutted."  *Black’s Law Dictionary* 1228 (8th ed. 2004).  One might conclude that if the preponderance of the evidence is required in these proceedings, that standard would also apply to the requirement for CMS to make a prima facie showing, i.e., CMS should be required to present evidence sufficient to establish a fact as more likely true and to raise a presumption, subject to being disproved or rebutted.  However, the Board has never specifically ruled that the CMS prima facie case must be supported by preponderant evidence, or what happens if it is not, including whether Petitioner has the burden of persuasion even if CMS failed to make a prima facie showing on each element of its case.  It is also unclear from prior Board decisions whether CMS can make a prima facie showing with mere allegations or a scintilla of evidence.

**B.  Issues**

Whether there is a basis for the imposition of an enforcement remedy; and

Whether the remedy imposed is reasonable.

**C.  Conclusions of Law**
                            CMS made a prima facie showing that Petitioner violated 42 C.F.R. § 483.45(e)(1) through (5) (Tag F758) based on the examples of Residents 45 and 115.

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                            Petitioner rebutted CMS’ prima facie showing of noncompliance under 42 C.F.R. § 483.45(e)(1) through (5) (Tag F758).
There is no basis for the imposition of an enforcement remedy.

These conclusions of law are based on the following findings of fact and analysis.  I have carefully considered all the evidence and the arguments of both parties, although not all may be specifically discussed in this decision.  I discuss the credible evidence given the greatest weight in my decision-making.5  I also discuss any evidence that I find is not credible or worthy of weight.  The fact that evidence is not specifically discussed should not be considered sufficient to rebut the presumption that I considered all the evidence and assigned such weight or probative value to the credible evidence that I determined appropriate within my discretion as an ALJ.  There is no requirement for me to discuss the weight given every piece of evidence considered in this case, nor would it be consistent with notions of judicial economy to do so.  Charles H. Koch, Jr., *Admin. L. and Prac.* § 5:64 (3d ed. 2013).

**D.  Findings of Fact and Analysis**
                            The Survey Process

As a preliminary matter it is important to understand the purpose of the survey process.  The Secretary has provided guidance for surveyors to follow in determining whether a facility is complying with participation requirements.  The Secretary has prescribed principles to be applied in determining compliance including the following:

The survey process uses resident and patient outcomes as the primary means to establish the compliance process of facilities and agencies.  Specifically, surveyors will directly observe the actual provision of care and services to residents and/or patients, and the effects of that care, **to assess whether the care provided meets the needs of individual residents and/or patients**.

42 C.F.R. § 488.26(c)(2) (emphasis added).  This regulation directs that surveyors:  (1) observe the actual provision of care and services to residents; (2) observe the effects

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of the care and services provided; and (3) assess whether the care and services provided meet the needs of the residents in order to determine compliance with participation requirements.  The Secretary’s guidance does not allow for a mechanical application of the regulations.  Rather, the survey process is generally an outcome-based approach.  This outcome-based approach is further demonstrated by the fact that substantial compliance is defined as "a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm."  42 C.F.R. § 488.301.  Therefore, long-term care facilities are generally not held to strictly comply with the participation requirements of 42 C.F.R. pt. 483.  Even if care and services are imperfect, so long as the care and services delivered meet the needs of the individual resident without posing a risk for more than minimal harm, a facility is in substantial compliance and there is no basis for imposing an enforcement remedy.

In this case, the surveyors and CMS attempt to mechanically apply the participation requirements related to the use of psychotropic drugs established by 42 C.F.R. § 483.45(e) without consideration of the plethora of evidence showing that the use of those drugs was necessary to meet the needs of the residents and that any violation of the regulations posed no risk for more than minimal harm.  More concerning is the fact that the surveyors’ and CMS efforts in this case may be viewed as an attempt to interfere with the decision-making and judgment of Resident 45’s physicians.  CMS and the surveyors appear to second guess Resident 45’s physicians’ prescribing decisions, clearly indicating their preference for non-pharmaceutical approaches.  CMS and the state agency have no authority delegated by the Secretary to interfere with physician treatment decisions in the context of the survey and certification of long-term care facilities.  In fact, Congress imposes upon every long-term care facility the requirement to ensure that the medical care of every resident is "provided under the supervision of a physician."  Act §§ 1819(b)(6)(A), 1919(b)(6)(A).
                            Noncompliance Subject to Review

The complaint investigation and survey completed on August 10, 2018, cited Petitioner for 13 regulatory violations (deficiencies) that amounted to noncompliance because they allegedly posed a risk for more than minimal harm.  However, the CMS notice dated November 28, 2018, shows CMS imposed an enforcement remedy based only upon the alleged violation of 42 C.F.R. § 483.45(c)(3) and (e)(1) through (5) (Tag F758, scope and severity (s/s)6 G).  CMS Ex. 2 at 2.  Only the citation of deficiency that was the basis for

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the imposition of an enforcement remedy is subject to appeal by Petitioner and review by me.  42 C.F.R. §§ 488.408(g), 488.330(e)(3), 498.3(b)(13) (facility may appeal certificate of noncompliance for which enforcement remedy imposed).  Therefore, Petitioner’s right to review and my authority to provide review is limited to Tag F758, the noncompliance for which the PICMP7 was imposed.  42 C.F.R. §§ 488.408(g)(1), 488.330(e)(3), 498.3(b)(13).
                            42 C.F.R. § 483.45(c)(3) Defines Psychotropic Drugs – Imposes No Substantive Legal Requirements on Petitioner

CMS and the surveyors allege that Petitioner violated 42 C.F.R. § 483.45(c)(3) and (e)(1)-(5).  CMS Ex. 1 at 70-71.  However, 42 C.F.R. § 483.45(c)(3) defines the term "psychotropic drug" and does not impose any substantive legal requirement upon

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Petitioner.  The substantive legal requirements related to psychotropic drugs with which Petitioner must comply are found in 42 C.F.R. § 483.45(e)(1) through (5).  Therefore, 42 C.F.R. § 483.45(c)(3) is not discussed as a basis for a finding of noncompliance and is only referred to for the definition of psychotropic drugs.
                            Psychotropic Drugs Involved

The surveyors allege Petitioner violated 42 C.F.R. § 483.45(e) based on the medications received by Resident 45 and Resident 115.  CMS Ex. 1 at 70-84.  There is no dispute that the three medications of concern to the surveyors were psychotropic drugs.

Pursuant to 42 C.F.R. § 483.45(c)(3), a psychotropic medicine is any medicine that affects brain activities associated with mental processes and behavior.  The regulation provides that psychotropic drugs include, but are not limited to, the following classes of drugs, (i) antipsychotics; (ii) antidepressants; (iii) antianxiety drugs; and (iv) hypnotics.

The noncompliance alleged by the surveyors under Tag F758 focused on three drugs.  CMS Ex. 1 at 70-84.  Both the proprietary names and the generic names of the drugs appear throughout the evidence.

CMS Exs. 8, 30, 39; Jt. Stip. at 3 ¶ 9; Tr. 268-69.  Where possible, both the generic and proprietary names appear together in this decision for the benefit of any appellate review authority.
                            Substantive Legal Requirements -- Sections 1819(c)(1)(D) and 1919(c)(1)(D) of the Act and 42 C.F.R. § 483.45(e)

The substantive legal requirements with which Petitioner must comply related to the use of psychotropic drugs are established by section 1819(c)(1)(D) of the Act and 42 C.F.R. § 483.45(e).  The parties do not specifically address the requirements Congress imposed in section 1819(c)(1)(D) of the Act, related to the use of psychiatric medications in nursing facilities.  Congress specified that:

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Psychopharmacologic drugs may be administered only on the orders of a physician and only as part of a plan (included in the written plan of care described in paragraph (2)) designed to eliminate or modify the symptoms for which the drugs are prescribed and only if, at least annually, an independent, external consultant reviews the appropriateness of the medicine plan of each resident receiving such drugs.  In determining whether such a consultant is qualified to conduct reviews under the preceding sentence, the Secretary shall take into account the needs of nursing facilities under this title to have access to the services of such a consultant on a timely basis.

Act §§ 1819(c)(1)(D), 1919(c)(1)(D).  Thus, Congress specified that psychotropic medications may be used if:  (1) ordered by a physician; (2) ordered as part of the written care plan; (3) the medicine ordered is designed to eliminate or modify the symptoms for which the medicine is prescribed; and (4) there is an annual independent consultant review of the appropriateness of the medicine plan for each resident receiving such drugs.  It should be noted that Congress did not specify that the medicine ordered be used only in the manner or for the reasons approved by the Food and Medicine Administration (FDA).

The Secretary has by regulation imposed significantly more detailed requirements for the use of psychotropic drugs in long-term care facilities.  Following are the substantive regulatory requirements established by 42 C.F.R. § 483.45(e):

(e) *Psychotropic drugs*.  Based on a comprehensive assessment of a resident, the facility must ensure that—

(1)  Residents who have not used psychotropic drugs are not given these drugs unless the medication is necessary to treat a specific condition as diagnosed and documented in the clinical record;

(2)  Residents who use psychotropic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs;

( 3) Residents do not receive psychotropic drugs pursuant to a PRN order unless that medication is necessary to treat a diagnosed specific condition that is documented in the clinical record; and

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(4)  PRN orders for psychotropic drugs are limited to 14 days.  Except as provided in § 483.45(e)(5), if the attending physician or prescribing practitioner believes that it is appropriate for the PRN order to be extended beyond 14 days, he or she should document their rationale in the resident’s medical record and indicate the duration for the PRN order.

(5)  PRN orders for anti-psychotic (sic) drugs are limited to 14 days and cannot be renewed unless the attending physician or prescribing practitioner evaluates the resident for the appropriateness of that medication.

42 C.F.R. § 483.45(e)(1)-(5) (emphasis added).  "PRN" is not defined in 42 C.F.R. pt. 483.  However, 42 C.F.R. § 482.13(e)(6) indicates that PRN means on an as needed basis.

It is important to note that 42 C.F.R. § 483.45(e) does not prohibit administering psychotropic medications to residents.  Rather, 42 C.F.R. § 483.45(e)(1) and (3) provide that a resident should not receive psychotropic drugs unless the medicine is necessary to treat a specific diagnosed condition that is documented in the clinical8 record.  Once psychotropic drugs are prescribed, the regulation requires that there be an effort to discontinue the drugs, unless clinically contraindicated.  42 C.F.R. § 483.45(e)(2).  The regulation does not prescribe the frequency or duration of gradual dose reductions or the use of alternate interventions.  The regulation does not require that when it is determined that a gradual dose reduction with or without alternate interventions is determined to be contraindicated, that there be repeated efforts at gradual dose reduction.  Under 42 C.F.R. § 483.45(e)(4), PRN orders for psychotropic drugs are limited to 14 days, unless the

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physician or practitioner determines and documents in the resident’s medical record that a PRN order should extend beyond 14 days and how long the extension should be.  The regulation provides an exception applicable only to antipsychotic drugs which may not be extended beyond 14 days but must be renewed only after a physician evaluation.  42 C.F.R. § 483.45(e)(5).  Subsection 483.45(e)(4) of 42 C.F.R. does not rule out the possibility that an indefinite extension may be ordered by a physician for a psychotropic drug, except in the case of an antipsychotic under 42 C.F.R. § 483.45(e)(5).  The regulation also does not prescribe that there be another review once the physician determines that the PRN psychotropic is necessary and determines for how long the PRN should be extended.  The regulation does not impose a substantive legal requirement regarding the frequency of the reevaluation of the use of psychotropic drugs following the initial 14-day evaluation, except in the case of antipsychotic drugs which are subject to 42 C.F.R. § 483.45(e)(5).  The regulation does not require that the physician or practitioner review the psychotropic medications, other than antipsychotics, every 14 days or preclude a determination that the extension of an order for a psychotropic other than an antipsychotic may be indefinite as the regulation does not impose any limit on the duration of the extension.  The only requirement is that the determination of need and duration be made by the resident’s attending physician or practitioner and be documented in the medical record.

A special exception for antipsychotic drugs is established by 42 C.F.R. § 483.45(e)(5).  The subsection provides that prescriptions for antipsychotics are limited to 14 days and cannot be renewed unless the physician or practitioner evaluates for the appropriateness of the drug.  CMS interprets 42 C.F.R. § 483.45(e)(5) to mean that an order may be for no more than 14 days at a time, and that a new order may not be issued until the resident is evaluated by the physician or practitioner.  CMS Ex. 6 at 8.  The regulation does not require that the evaluation of the resident be hands-on or in person.  42 C.F.R. § 483.45(e)(5).
                            CMS Policies Related to 42 C.F.R. § 483.45(e)

CMS provides its policy guidance to surveyors in the SOM.  The SOM is not promulgated by notice and comment rule making under section 1871 of the Act.  Section 1871 of the Act requires that the Secretary promulgate by regulation a rule, requirement, or other statement of policy, except for national coverage determinations, that establish or change a substantive legal standard that governs the scope of benefits, the payment for services, or the eligibility of individuals, entities, or organizations to furnish or receive services or benefits under Medicare.  Therefore, the required notice for any substantive legal standard to be enforced as law is promulgation as a regulation.  Act § 1871(a)(1)-(2).  If CMS seeks to enforce an interpretative rule or policy (such as the SOM) that effectively imposes a substantive legal standard without notice and comment rulemaking under section 1871 of the Act, then the United States Supreme Court decision in *Azar v.*

*Page 14*

*Allina Health Services*, 588 U.S. __, 139 S. Ct. 1804 (2019) indicates that that substantive legal standard is not enforceable.

CMS instructs surveyors in the SOM that:

**The regulations and guidance concerning psychotropic medications are not intended to to (sic) supplant the judgment of a physician or prescribing practitioner in consultation with facility staff, the resident and his/her representatives and in accordance with appropriate standards of practice.**  Rather, the regulations and guidance are intended to ensure psychotropic medications are used only when the medication(s) is appropriate to treat a resident’s specific, diagnosed, and documented condition and the medication(s) is beneficial to the resident, as demonstrated by monitoring and documentation of the resident’s response to the medication(s).

CMS Ex. 6 at 15 (emphasis added).  This guidance is consistent with the direction of Congress in sections 1819(c)(1)(D), 1919(c)(1)(D) of the Act.  In short, it is not for the state agency or CMS to decide whether the use of psychotropics is necessary and appropriate.  Rather, CMS and the state agency are to determine whether there is a specific, diagnosed, and documented condition and that documented monitoring of the use of the medication and the resident’s response shows that the medication is beneficial to the resident.  This clear, understandable, and practical statement of CMS policy, which seems to be ignored by CMS in this case, guides my further analysis.

Regarding antipsychotic medications, CMS instructs surveyors as a matter of policy in the SOM that the indication for use of antipsychotic medication must be thoroughly documented in the medical record; the resident’s interdisciplinary team (IDT) 9 must, before prescribing antipsychotic mediation, identify and address any medical, physical, psychological causes, and social or environmental triggers; and the antipsychotic must be administered in the lowest possible dose for the least amount of time.  CMS states that antipsychotic medications are subject to the gradual dose reduction requirement of

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psychotropic medication.  CMS Ex. 6 at 17.  An attending physician or prescribing practitioner issues orders for medications not the IDT.  42 C.F.R. § 483.45(e).  However, the IDT, which includes a resident’s attending physician, would be involved in developing and reviewing the care plan.  42 C.F.R. § 483.21(b)(2)(ii).  Therefore, I infer that it is the treating physician, probably in consultation with the IDT, who determines the lowest possible dose, and whether gradual dose reduction is contraindicated.

CMS states in the SOM that diagnoses alone do not justify the use of an antipsychotic medication, but an antipsychotic may be indicated when:  (1) behavioral symptoms pose a danger to the resident or others; (2) the resident is demonstrating significant distress; (3) unless contraindicated, the use of multiple non-pharmacological approaches have been attempted but did not relieve symptoms causing significant distress; and/or (4) gradual dose reduction was attempted but symptoms recurred.  If antipsychotic medication is prescribed, CMS states that there must be documentation that:  (1) the antipsychotic medication is needed; (2) there have been multiple attempts to implement care planned non-pharmacological interventions; and (3) there is ongoing evaluation of the effectiveness of the non-pharmacological interventions.  CMS Ex. 6 at 18.

CMS policy for prescribing psychotropic medication PRN, excluding antipsychotics, provides a time-limit of 14 days for the PRN order.  However, the attending physician or prescribing practitioner may determine to extend the order and, if so, should document the rational in the medical record and indicate a specific duration.  CMS policy regarding prescribing PRN antipsychotic medication imposes a 14-day time-limit with no provision for extension of an order for an antipsychotic.  CMS policy states that after 14 days the attending physician or prescribing practitioner may write a new order but must first directly examine the resident and assess the resident’s current condition and progress to determine if the new order is appropriate.  The physician or practitioner should record in the resident’s medical record whether the antipsychotic continues to be needed on a PRN basis, the benefit of the PRN medication to the resident, and whether the resident’s expressions or indications of distress improved due to the PRN antipsychotic.  CMS Ex. 6 at 20-21.

CMS also states as policy in the SOM that "the failure of the facility to provide appropriate care and services to manage the resident’s medication regime to avoid unnecessary mediation and minimize negative outcomes places a resident at risk for more than minimal harm."  CMS Ex. 6 at 28.  The statement shows that CMS does not recognize that a violation of 42 C.F.R. § 483.45(e) may not pose a risk for more than minimal harm.  Therefore, the CMS policy indicates that CMS treats all violations of 42 C.F.R. § 483.45(e) as noncompliance and a basis for an enforcement remedy.  This policy is, on its face, inconsistent with the regulatory requirement that the survey process is to be based on resident outcomes, except to the extent that the CMS policy is only read to establish a rebuttable presumption that a violation of 42 C.F.R. § 483.45(e) posed a risk for more than minimal harm.  42 C.F.R. § 488.26(c)(2).

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                            Resident 45 -- Findings and Analysis Related to 42 C.F.R. 483.45(e)(1) through (5)

Resident 45 was born October 28, 2016, prematurely by cesarean section due to preterm labor of unknown cause.  She was intubated in the delivery room, and she was admitted to a community hospital neonatal intensive care unit.  Following an exploratory surgery, she developed necrotizing fasciitis and was transferred to Children’s on November 16, 2016, for treatment.  CMS Ex. 35 at 143.  Resident 45 was subsequently sent to Petitioner where she was admitted on May 30, 2017, when she was seven months old.  CMS Ex. 13.

Resident 45 was 21 months old when the survey was completed on August 10, 2018.  Resident 45 was at that time in her third admission to Petitioner, which commenced on April 3, 2018, just over four months before the survey.  Her primary physician listed on her record of admission was Danieli Salinas, MD.10  Diagnoses listed on her admission record for her April 3, 2018 admission to Petitioner included chronic respiratory failure, respirator (ventilator) dependence, she had a tracheostomy, pulmonary hypertension, adrenocortical insufficiency, restlessness and agitation, and she had a gastrostomy for feeding.  CMS Exs. 13, 18; Jt. Stip. at 2 ¶ 5.  It is important to know that Resident 45 was readmitted to Petitioner after her hospitalization at Children’s from March 26 to April 3, 2018.  It is also important that the Children’s discharge summary listed dysautonomia as her discharge diagnosis.  CMS Ex. 35 at 11.

The CMS portrayal of Petitioner’s care and treatment of Resident 45 is that Petitioner maintained the resident on psychotropics (Ativan® (lorazepam) and Seroquel® (quetiapine)) with a PRN dose of each to keep the resident sedated and make her easier to care for.  CMS Br. at 15-16.  To paint its picture, CMS wants to focus us on the limited period of April 3, 2018 through August 2018.  However, such a narrow focus greatly distorts the severity of Resident 45’s medical impairments and the care and services Resident 45 actually needed and received from both her physicians at Children’s and Petitioner’s staff.  It is important and necessary to review what is effectively Resident 45’s entire albeit brief medical history to understand the context for the delivery of care and services to her by Petitioner as ordered by the Resident 45’s primary care physician based on recommendations of physicians at Children’s.  Doing so reveals that the allegations of CMS are out of context and do not show any noncompliance for which an enforcement remedy may be imposed.

To understand Resident 45’s case it is necessary to have a longitudinal perspective.  Resident 45 had an extensive medical history dating from her birth and much of the

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history is recorded in records from Children’s.  Although CMS placed in evidence most of the records from Children’s that are before me (CMS Ex. 34 and 35), CMS argues that Petitioner cannot rely on those records in support of its case.  The records of Children’s, which I infer are from the medical record of Resident 45 maintained by Petitioner because they were obtained by the surveyors during the August 2018 survey,11 are the most credible evidence of the resident’s medical history.12  CMS argues that Petitioner cannot rely upon Children’s records because it has an independent duty to keep its own, complete clinical records of its patients citing 42 C.F.R. § 483.70(i)(1).  CMS Br. at 7.  Indeed, Petitioner is required to keep a medical record for each of its residents that is complete, accurately documented, readily accessible, and systemically organized.  42 C.F.R. § 483.70(i)(1).  The medical record must contain:  sufficient information to identify the resident; a record of the resident’s assessments; the comprehensive plan of care and services provided; the results of any preadmission screening and resident reviews conducted by the state; progress notes of physicians, nurses, and other licensed professionals; and laboratory, radiology, and other diagnostic services reports.  42 C.F.R. § 483.70(i)(5).  The regulation does not require, for example, that a long‐term care facility obtain for a resident’s medical records, the records of hospitals, nursing facilities,

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or other institutions from which a resident is received, or the records of treatments delivered to the resident by suppliers of services not arranged or provided by Petitioner or on Petitioner’s premises.  However, there should be no contention that if a facility obtains other provider and supplier records and adds them to the resident’s medical record, it should have the effect of giving staff and physicians a better perspective on the resident’s health and well-being and need for care and services.  When as in this case a long-term care facility has third-party records in the medical record of a resident, there is no specification by CMS in regulation or policy that the records must be in a particular form and there is no prohibition on such records being in the form in which they were received from the other provider or supplier.  Absent a specific legal or policy requirement to the contrary, records in whatever form accessible in a resident’s medical record should be treated as part of that resident’s medical record.  Further, given the advent of electronic medical records that can be shared among physicians, practitioners, hospitals, long-term care facilities, records accessible to a facility’s staff should arguably considered part of the resident’s medical records.  *See e.g.*, 45 C.F.R. §§ 164.506(c), 164.510.  In this case, I infer that the Children’s records placed in evidence by CMS were obtained by the surveyors during the surveyor of Petitioner from Petitioner’s medical record for Resident 45.  Accordingly, I reject CMS’ argument that the documents from Children’s hospital that CMS placed in evidence cannot be considered and given weight.

**Resident 45’s Medical History to April 3, 2018**

The focus of this summary is the use of psychotropic medications which are the covered by 42 C.F.R. § 483.45(e) – the regulation the surveyors allege Petitioner violated.  Ativan® (lorazepam) and Seroquel® (quetiapine) are the two psychotropic medications that are involved in the example of Resident 45.  Other drugs are mentioned only because the records reflect some use to address Resident 45’s agitation/irritability.  It is important to remember that the records show and there is no dispute between the parties, that Resident 45 was severely impaired and unable to communicate except by crying, screaming, and sometimes smiling.  Physician summaries in CMS Ex. 35 show that the various experts at Children’s who attended to Resident 45 had to speculate as to whether her behaviors, including agitation and/or irritability were due to pain or some other cause.  CMS Ex. 35 at 29, 47; Tr. 135-37.  The evidence shows that she was given many different pain medications for example morphine, Dilaudid® (hydromorphone), and Tylenol® (acetaminophen) for pain, simethicone to relieve possible gas pains, and laxative and enemas to relieve constipation, but the use of these drugs is not at issue in this case.  CMS Exs. 14, 20.

Copies of records from various departments of Children’s from the period June 9, 2017 (shortly after Resident 45’s initial admission to Petitioner) through March 6, 2018, show problems and diagnoses addressed as possible bases for continuing problems with agitation and irritability, including dysautonomia (CMS Ex. 35 at 3), seizures, autonomic storm, spasticity, neuro-agitation and neuro-irritability secondary to extensive cystic

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encephalomalacia with neurologic devastation (CMS Ex. 35 at 1-4, 9-10, 129), and bradycardia and hypotension (CMS Ex. 35 at 1-10, 52-89).  The records show, as detailed hereafter, that Children’s physicians used opioids to control the resident’s agitation/irritability, I infer based on an assessment that her pain was a contributing factor.  The records also show that the physicians used the psychotropics Ativan® (lorazepam) and Seroquel® (quetiapine) to attempt to control the resident’s agitation as well as simethicone apparently because digestive gas buildup can cause discomfort and agitation.  CMS Ex. 35 at 29, 47.  The evidence shows repeated efforts to wean13 Resident 41 from opioids and also to limit use of and wean the resident from psychotropics.  I infer based on the evidence, that Resident 45’s physicians could not be sure whether her agitation was caused by pain, abdominal discomfort due to gas or overfeeding, her brain damage, or some other cause as Resident 45 could not communicate and likely never will.  CMS Ex. 35 at 29, 47; Tr. 135-37.  It would be unreasonable in this case to ignore the efforts of Resident 45’s physicians at Children’s and the effort of her treating physician who issued prescriptions recommended by the consulting physicians at Children’s during the period preceding that interests CMS, in assessing whether there was compliance with 42 C.F.R. § 483.45.  The following summary is based on the records from Children’s placed in evidence by CMS, records I infer were obtained by the surveyors during the survey of Petitioner and from the records of Petitioner, providing a snapshot of Resident 45 and efforts to manage her agitation/irritability.

On June 9, 2017, Resident 45, who was residing at Petitioner, was seen as a new patient in the Chronic Pain Clinic at Children’s for a medication/sedation wean from methadone.  It is noted that she had difficulty weaning from methadone.  However, Ativan® (lorazepam) was prescribed by "[Petitioner’s] physician"14 with good benefit, she was no

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longer agitated but still responsive.  CMS Ex. 35 at 159.  Her medication list included Dilaudid® (hydromorphone) every four hours PRN for agitation/irritability, Ativan® (lorazepam) every six hours and PRN for agitation/irritability, and simethicone daily PRN for agitation/irritability.  CMS Ex. 35 at 158-59.  The plan was to continue to wean Resident 45 from the methadone and then wean her from Ativan® (lorazepam).  CMS Ex. 35 at 162-63.

On July 10, 2017, Resident 45 was seen in Children’s High Risk Infant Follow-up Clinic.  She was noted to be extremely irritable.  CMS Ex. 35 at 230.  Her medication list included Dilaudid® (hydromorphone) every four hours PRN for agitation/irritability, Ativan® (lorazepam) every six hours and PRN for agitation/irritability, and simethicone daily PRN for agitation/irritability.  CMS Ex. 35 at 227.

Resident 45 was seen in the neurology department at Children’s on July 17, 2017, for "neuro-agitation and neuro-irritability secondary to extensive cystic encephalomalacia with neurologic devastation."  CMS Ex. 35 at 129.  At the time of the visit, she was being weaned off methadone, but required frequent doses of Dilaudid® (hydromorphone) to calm her due to neuro-agitation.  Her prescriptions included Dilaudid® (hydromorphone) every four hours PRN for agitation/irritability and Ativan® (lorazepam) every six hours PRN for agitation/irritability, simethicone every day as necessary for agitation/irritability.  CMS Ex. 35 at 129, 143.  Resident 45 was extremely agitated and inconsolable during the examination.  CMS Ex. 35 at 144.  The examination was "extremely limited due to ongoing neuro-irritability and neuro-agitation."  CMS Ex. 35 at 145.

On August 29, 2017, Resident 45 was seen by pain management at Children’s for a medication/sedation wean.  Resident 45 was off methadone as of August 28, 2017.  She was being given Dilaudid® (hydromorphone) once or twice each day when she was not consolable.  It was noted that her agitation was not associated with a particular trigger and that she easily calmed down.  She also continued to receive Ativan® (lorazepam).  Her medication list included Dilaudid® (hydromorphone) every four hours and PRN for agitation/irritability, Ativan® (lorazepam) every six hours and PRN for agitation/irritability, and simethicone daily for agitation/irritability.  CMS Ex. 35 at 164-65.

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On September 18, 2017, Resident 45 was seen in the Children’s pain clinic for medication wean.  CMS Ex. 35 at 169-173.  It was noted that she was not needing Dilaudid® (hydromorphone) PRN as often and she continued gabapentin, clonidine, and Ativan® (lorazepam).  Her medications list included Dilaudid® (hydromorphone) every four hours and PRN for agitation/irritability, Ativan® (lorazepam) every six hours and PRN for agitation/irritability, and simethicone daily and PRN for agitation/irritability.  CMS Ex. 35 at 170-71.  The plan was to wean her from Ativan® (lorazepam) over seven weeks.  She was to return to the pain clinic two months after completing the wean.  CMS Ex. 35 at 173.  She was also seen in the neurology clinic at Children’s on September 18, 2017, for follow-up.  At the time of the visit, she had been weaned of methadone and was being weaned from Ativan® (lorazepam).  Petitioner’s nurses reported to the physician at Children’s that there were on-going issues with neuro-agitation while tapering off sedation and Resident 45 was not tolerating changes in positions with transfers, I infer due to pain.  Medications listed included Ativan® (lorazepam) every six hours and PRN for agitation/irritability, Dilaudid® (hydromorphone) every four hours and PRN for agitation/irritability, and simethicone everyday PRN for agitation/irritability.  CMS Ex. 35 at 221-22.  Resident 45 was noted to be extremely agitated and inconsolable during the examination.  CMS Ex. 35 at 223.  The plan was to continue medications as prescribed with interventional therapies as tolerated in addition to stretching and strengthening exercises.  CMS Ex. 35 at 224.

Resident 45 was admitted to Children’s on October 7, 2017, for a consultation for bradycardia and hypotension and concern for possible septic shock.  CMS Ex. 35 at 1-10, 52-89.  Resident 45 was at that time of admission prescribed PRN Dilaudid® (hydromorphone) every four hours for agitation/irritability, lorazepam (Ativan®) every six hours for agitation/irritability, and simethicone once a day for agitation/irritability.  CMS Ex. 35 at 1-2.  Her bradycardia was thought to most likely be the result of her dysautonomia and high vagal tone due to her neurologic devastation.  CMS Ex. 35 at 3.  Her discharge instructions were for lorazepam (Ativan®) every six hours, quetiapine (Seroquel®) every eight hours and every hour PRN for agitation/irritability, and simethicone once a day as needed for agitation/irritability.  CMS Ex. 35 at 56.  She received a neurology consultation for evaluation for possible seizures, autonomic storm, or spasticity.  Ativan® (lorazepam) was used on a PRN basis to resolve episodes that involved heart rate elevated to the 190s and were speculated to be the result of seizure activity, autonomic storm, or spasticity.  CMS Ex. 35 at 1-4, 9-10.  Notes from a physician consultation indicate that Resident 45 had been weaned off methadone for neuro-agitation, but it was restarted while she was in septic shock and she weaned again on October 11, 2017, and the methadone was discontinued on October 13, 2017.  CMS Ex. 35 at 4, 7, 61.

On November 20, 2017, Resident 45 was seen in the Children’s pain clinic related to her medication wean.  CMS Ex. 35 at 174-82.  It is noted that Resident 45 had been started on Seroquel® (quetiapine) for agitation.  Her caregiver reported some agitation lasting

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minutes to an hour mid-morning and afternoon without an identifiable trigger.  It is stated that comfort measures usually work but if not Resident 45 was given Tylenol®.  CMS Ex. 35 at 175.  Her medication list included Ativan® (lorazepam) every six hours for maintenance, Seroquel® (quetiapine) every hour and PRN for agitation/irritability, and simethicone daily and PRN for agitation/irritability.  CMS Ex. 35 at 175-76.  The plan was to continue her Ativan® (lorazepam) wean over the next four weeks.15  CMS Ex. 35 at 180-81.  However, a subsequent note on the same date indicates that Petitioner’s staff reported increased agitation that did not seem pain related.  Staff reported they could console Resident 45, but she required more than they could provide.  The physician states it is reasonable to add Ativan® (lorazepam) PRN.  CMS Ex. 35 at 182.

On November 30, 2017, Resident 45 was seen in the Comfort and Palliative Care Clinic of Children’s, with chief complaints of respiratory failure, neurologic injury, and to set or review goals for care.  CMS Ex. 35 at 136-42.  She was noted to sleep well at Petitioner, she appeared more comfortable, and she had more time awake and calm.  CMS Ex. 35 at 136-37.  Her prescriptions included Ativan® (lorazepam) every six hours for maintenance; Seroquel® (quetiapine) every eight hours for maintenance; and simethicone daily for maintenance.  CMS Ex. 35 at 138-39.  No normal motor activity, speech, or coordination was observed.  She was to be continued on her current medication but the "Pain team [was] working on Ativan wean."  CMS Ex. 35 at 141.  Movement and other therapies were to be continued at Petitioner.  CMS Ex. 35 at 142.

On January 10, 2018, Resident 45 was seen in the neurology department at Children’s.  It was reported by Resident 45’s nurse that her baseline was to be relaxed and calm.  However, she continued to have neuro-agitation and neuro-irritability, with her suddenly becoming agitated, crying, screaming, and flushing.  Sometimes the episodes were triggered by a dirty diaper, but they also occurred without a trigger.  She was given Dilaudid® (hydromorphone) for these episodes.  CMS Ex. 34 at 6; CMS Ex. 35 at 146.  Her medications included Dilaudid® (hydromorphone) every four hours and PRN for agitation/irritability.  CMS Ex. 34 at 7; CMS Ex. 35 at 146-47.  However, it was also recommended that her prescription for gabapentin be increased to help with her agitation.  CMS Ex. 34 at 8; CMS Ex. 35 at 148-149.  The notes/final report for this visit in evidence in CMS Ex. 34 and CMS Ex. 35, do not list Ativan® (lorazepam) or Seroquel® (quetiapine) as medications for Resident 45.  However, the final report of Resident 45’s neurology clinic visit on January 10, 2018, lists prescriptions including lorazepam (Ativan®) every six hours, quetiapine (Seroquel®) every eight hours and PRN every

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hour for agitation/irritability, and simethicone four times per day PRN for agitation/irritability.  CMS Ex. 35 at 24-26.  These records show that the examinations were conducted within about 45 minutes of each other on January 10, 2018.  I can detect no reason from the face of the documents for the discrepancy.  I consider both documents equally weighty.  Nevertheless, I find it more likely than not that the more detailed medication list at CMS Ex. 35 at 25-26 is the accurate list of Resident 45’s medications and that she was prescribed at that time Ativan® (lorazepam) and Seroquel® (quetiapine).

On February 12, 2018, Resident 45 was seen in the Children’s High Risk Infant Follow Up Clinic.  CMS Ex. 35 at 36-40.  Her prescriptions included lorazepam (Ativan®) every six hours, quetiapine (Seroquel®) every eight hours and PRN every hour for agitation/irritability, and simethicone four times per day PRN for agitation/irritability.  CMS Ex. 35 at 36-38, 232-237.  Agitation was noted to be an ongoing concern.  Petitioner was trying to wean the resident off Dilaudid® (hydromorphone).  CMS Ex. 35 at 233.

On February 26, 2018, Resident 45 was seen in the Children’s Center for Endocrinology, Diabetes and Metabolism.  CMS Ex. 35 at 30-33.  Her prescriptions included lorazepam (Ativan®) every six hours quetiapine (Seroquel®) every eight hours and PRN every hour for agitation/irritability, and simethicone four times per day PRN for agitation/irritability.  CMS Ex. 35 at 30-31.  Resident 45 was also seen in the otolaryngology department for tracheostomy care and she was cleared to have hearing aids.  CMS Ex. 35 at 213.

A final report from Children’s Pain and Palliative Care Center dated March 6, 2018, shows that Resident 45 was seen for a follow-up.  CMS Ex. 35 at 16.  Her prescriptions were lorazepam (Ativan®) every six hours; quetiapine (Seroquel®) every eight hours and PRN for agitation/irritability; and simethicone four times a day and as needed for agitation/irritability.  CMS Ex. 35 at 17-18.  Orders included continuing Ativan® (lorazepam) every six hours as needed with monitoring of use and weaning Resident 45 to Seroquel® (quetiapine) twice daily for two months.  CMS Ex. 35 at 20.

Resident 45 was also seen in the pain management clinic at Children’s on March 6, 2018, for follow-up with her medication wean.  What medicine she was being weaned from is not clearly stated.  However, I infer based on the preceding report from February 12, 2018, that the reference is to the Dilaudid® (hydromorphone) wean that was being done at Petitioner.  CMS Ex. 34; CMS Ex. 35 at 130-35.  Notes from the visit indicate that Resident 45 had done well following her wean and her continued episodes of agitation were well-controlled with PRN Ativan® (lorazepam) that was administered zero to twice per day.  Her medication list shows that she also received Ativan® (lorazepam) every six hours for maintenance, Seroquel® (quetiapine) every eight hours for maintenance and every hour PRN for agitation/irritability, and simethicone once per day for agitation/irritability.  CMS Ex. 34 at 2-3; CMS Ex. 35 at 131-32, 34.  The assessment

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notes that Resident 45 was doing well with the medication wean and intermittent agitation was well-controlled.  The assessment also indicates that a Seroquel® (quetiapine) wean was discussed.  CMS Ex. 34 at 4; CMS Ex. 35 at 134.  The plan provided for Ativan® (lorazepam) every six hours PRN; Dilaudid® (hydromorphone) every four hours PRN for pain; weaning from Seroquel® (quetiapine) to twice daily for two months, and monitoring Ativan® (lorazepam) use.  CMS Ex. 35 at 134.

Petitioner’s record of physician orders includes an order to wean Resident 45 to fewer doses of Seroquel® (quetiapine).  On March 6, 2018, it was ordered by Dr. Sally Ward that Seroquel® (quetiapine), which was prescribed for every eight hours for neuro-agitation, be discontinued.  Resident 45 was to be weaned to Seroquel® (quetiapine) 6.25 mg twice each day until May 7, 2018, when she had her Children’s pain clinic appointment.  CMS Ex. 14 at 9; CMS Ex. 20 at 10, 28.  This evidence shows that a Seroquel® (quetiapine) wean was put in place by Dr. Ward per the recommendations of Children’s physician.  This evidence shows that physicians at Children’s considered weaning to include a dose or frequency reduction of a medication not just eliminating a medication completely.  This evidence also illustrates that when a resident/patient is on a maintenance dose of a medication and a PRN dose, reducing or eliminating either the PRN dose or the maintenance dose may be considered weaning.

Resident 45’s condition leading up to her next hospitalization at Children’s is reflected in nursing notes from Petitioner placed in evidence by CMS.  CMS placed in evidence a collection of "24 Hour Nursing Flowsheets" related to Resident 45 dated from March 1, 2018 through August 8, 2018.  The flowsheets placed in evidence do not cover every day during the period and not all the hand-written notes are readable.  However, the following pertinent incidents are extracted from the flowsheets in evidence.  The notes reflect the use of nonpharmacologic interventions, use of medication other than psychotropics, assessments of the resident, and effectiveness of the various medications reported in the nursing notes.

March 3, 2018, at 1:00 a.m., Resident 45 was agitated, and her heart rate was 180 beats per minute.  She was given PRN Ativan® (lorazepam), which was effective to reduce the resident’s heart rate and permit or cause her to sleep.  CMS Ex. 29 at 5.

March 4, 2018, at 1:45 a.m. Resident 45 was agitated, and her heart rate was 170 beats per minute.  She was given PRN Ativan® (lorazepam), which was effective as shown by a decline in heart rate and allowing or causing the resident to sleep.  CMS Ex. 29 at 8.  At 9:45 p.m. a respiratory therapist changed the ties that held Resident 45’s tracheostomy tube in place.  At 10:55 p.m., the respiratory therapist discovered that Resident 45’s tracheostomy tube was out, and the backup tube was inserted, which caused some bleeding from the tracheostomy.  At 11:05 p.m. the resident was given Tylenol® for discomfort as her heart rate was over 200.  At

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11:45 p.m. the Tylenol® was ineffective as the resident was crying and her heart rate continued to be greater than 200.  PRN Ativan® (lorazepam) was given.  The Ativan® (lorazepam) was effective in reducing the resident’s heart rate and allowing or causing her to sleep.  CMS Ex. 29 at 11.

March 6, 2018, at 3:50 p.m. a new order was entered to discontinue Seroquel® (quetiapine) every eight hours for neuro-agitation and wean Seroquel® (quetiapine) to twice per day until May 7, 2018, Resident 45’s next Children’s pain clinic appointment.  CMS Ex. 29 at 17.

March 9, 2018, at 4:00 a.m. Resident 45 was agitated with her heart rate in the 170s.  Repositioning was ineffective because she continued to be agitated.  She was given PRN Ativan® (lorazepam), which was effective to reduce her heart rate and permit or cause her to sleep.  CMS Ex. 29 at 26.

March 10, 2018, at 11:25 a.m. Resident 45 was thought to have discomfort manifested by crying and a heart rate in the 160s.  She was repositioned and given Tylenol® which was not effective manifested by continued crying and increased heart rate.  At 12:20 p.m. Resident 45 was given PRN Ativan® (lorazepam), which was effect to allow or cause her to sleep and reduce her heart rate.  CMS Ex. 29 at 29.

March 11, 2018, at 10:00 a.m. PRN Ativan® (lorazepam) given due to Resident 45’s agitation evidenced by tachycardia, grimacing, and crying.  Repositioning and holding did not calm the resident.  The Ativan® (lorazepam) was effective as the resident was subsequently reported to be calm and asleep.  CMS Ex. 29 at 32.

March 22, 2018, at 7:30 a.m. Resident 45 was transported to Children’s.  On return at 10:25 a.m. the transport nurse reported that she had to give Resident 45 her PRN Ativan® (lorazepam) due to agitation evidenced by crying and posturing.  The Ativan® (lorazepam) was noted to be effective with Resident 45 calm and sleeping.  CMS Ex. 29 at 65.

March 23, 2018, at 7:00 a.m. Resident 45 was noted to be crying with a heart rate greater than 200 beats per minute.  She was repositioned and a "cooling measure" was applied.  At 7:30 a.m. her heart rate had dropped to 189 and she was not crying.  At 8:30 a.m. she was crying with heart rate greater than 200.  Resident 45 was repositioned.  At 9:00 a.m. Resident 45 remained tachycardic with a heart rate greater than 200 beats per minute and she was crying.  She was given Dilaudid® (hydromorphone) and "cooling measure" remained in place.  At 10:00 a.m. Resident 45’s heart rate had dropped to the 130s, and she stopped crying.  From about 10:30 a.m. to 7:30 p.m., Resident 45’s heart rate continued in the range of

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130 to 180 and at 7:30 p.m. she was noted to be easily agitated.  CMS Ex. 29 at 68.

March 24, 2018, at 1:00 a.m. Resident 45 was crying and agitated with heart rate of 180.  PRN Tylenol® was given for discomfort.  The Tylenol® appears to have been effective as Resident 45’s heart rate dropped to 89 and she went to sleep.  CMS Ex. 29 at 69.

March 24, 2018, at 10:45 a.m. Resident 45 crying with heart rate in the 190s which increased to the 200’s.  Ativan® (lorazepam) was administered at 11:00 a.m.  At 11:30 a.m. her heart rate had dropped to 108 and she was noted to be calm.  At 8:35 p.m. Resident 45 was given PRN Ativan® (lorazepam) for agitation and heart rate of 150.  At 11:00 p.m. Resident 45 was agitated with a heart rate in the 140s and she was repositioned for comfort.  CMS Ex. 29 at 71-72.

March 25, 2018, at 1:30 a.m. Resident 45 was agitated and crying.  She was given Tylenol® (acetaminophen).  At 2:30 a.m. Tylenol® (acetaminophen) was noted to have been effective as the resident was calm and sleeping.  CMS Ex. 29 at 72.  At 7:30 p.m. Resident 45 was crying and agitated.  At 8:00 p.m. Resident 45 continued to be agitated and crying and she was repositioned for comfort.  At 9:00 p.m. Resident 45 was given Dilaudid® (hydromorphone) for agitation as manifested by crying and heart rate in 160s.  CMS Ex. 29 at 74-75.

March 26, 2018, at 2:00 a.m. Resident 45 was crying and she was repositioned for comfort.  CMS Ex. 29 at 74.

March 26, 2018, at 10:00 a.m. Resident 45’s heart rate dropped into the 60s.  At noon her heart rate continued to be 58 to 60.  At 12:45 p.m. Resident 45’s mother was advised the resident was being transferred to Children’s due to her low heart rate and the fact she was difficult to arouse.  CMS Ex. 29 at 77.

Resident 45’s medication regime in March 2018 is reflected in Petitioner’s Medication Administration Record (MAR) for the resident.  March 2018 MARs list a prescription issued October 21, 2017, for 6.25 mg (milligrams) of Seroquel® (quetiapine) administered through the feeding tube every eight hours for neuro-agitation.  The order, initially ordered on October 21, 2017, was followed until March 6, 2018, when it was discontinued, and a new order was issued.  CMS Ex. 20 at 28.  On March 6, 2018, the new order issued by Dr. Ward was to wean Resident 45 to Seroquel® (quetiapine) 6.25 mg though her feeding tube twice per day until May 7, 2018, her next appointment at Children’s pain clinic.  CMS Ex. 14 at 9; CMS Ex. 20 at 35.  This new order was implemented until Resident 45 was sent to Children’s on March 26, 2018.  CMS Ex. 20 at 35.  The March 2018 MARs also list a prescription issued January 10, 2018, for Ativan® (lorazepam) 0.4 mg administer by feeding tube every six hours PRN for

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agitation manifested by rapid heart rate, rapid breathing, and crying.  The PRN Ativan® (lorazepam) was used 14 times in March 2018 on 11 days.  CMS Ex. 20 at 33-34.  The March 2018 MARs list prescriptions for Tylenol® (acetaminophen) for fever or pain; Motrin® (ibuprofen) in case Tylenol was ineffective or the maximum dose had been given; gabapentin for spasticity; clonidine for neuro-agitation; simethicone for gas; and for constipation polyethylene glycol, glycerin suppository, and enema.  CMS Ex. 20 at 28, 29, 32, 33.

The evidence shows that Resident 45 was readmitted to Children’s on March 26, 2018, and she was discharged on April 3, 2018.  CMS Ex. 23 at 3-6; CMS Ex. 35 at 11-14, 90-122, 183-204.  She was admitted for evaluation for the possibility of infection, sepsis, adrenal insufficiency, dystonia, and/or increasing dysautonomia.  CMS Ex. 35 at 90, 111.  According to her discharge and transfer summary, her discharge diagnosis for that admission was dysautonomia.  CMS Ex. 35 at 11.  Her prescriptions included lorazepam (Ativan®) every four hours and every six hours PRN for agitation/irritability; quetiapine (Seroquel®) three times per day and every hour PRN for agitation/irritability; and simethicone four times per day PRN for agitation/irritability.  CMS Ex. 23 at 4; CMS Ex. 35 at 12.  Her discharge summary shows that she was treated for possible pneumonia or tracheitis (infection of the trachea (CMS Ex. 35 at 101)).  It is noted that Resident 45’s agitation and dysautonomia consistently responded to being held and gently rocked.  However, she still became agitated one to two times per day with increased heartrate but her PRN medications and interventions such as holding, bathing, and rocking calmed her down.  The palliative care team agreed to follow her as an outpatient.  Psychiatry recommended increasing her Seroquel® (quetiapine) to three times per day because she had increased agitation during the month her Seroquel® was reduced to twice per day.  The new medication regime recommended by the palliative care team included Ativan® (lorazepam) every four hours; clonidine every eight hours as the first treatment for agitation/irritability, Ativan® (lorazepam) PRN every six hours as a second-line treatment for agitation/irritability; and increasing Seroquel® (quetiapine) administered to three times per day (because the recent attempt to wean Resident 45 had caused increased dysautonomia over the past month) and every hour PRN for agitation/irritability.  CMS Ex. 35 at 22-23, 42, 91, 93-94.

**Resident 45’s Medical History April 3, 2018 to Survey**

The evidence shows that Resident 45 had to be readmitted to Children’s on March 26, 2018.  She was subsequently discharged to Petitioner on April 3, 2018, the beginning of the limited period on which CMS chooses to focus.  CMS Ex. 23 at 3-6; CMS Ex. 35 at 11-14, 90-122, 183-204; CMS Br. at 12.

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The recommendations of the physicians at Children’s were implemented for Resident 45.  Petitioner’s record of physician orders16 by Resident 45’s physician, Dr. Danieli Salinas, showed the increase in Seroquel® (quetiapine) and other pharmacologic interventions to address possible causes of Resident 45’s continuing problems with agitation and/or irritability.  On April 3, 2018, Ativan® (lorazepam) was ordered for every four hours and PRN every six hours for agitation/irritability.  Seroquel® (quetiapine) was ordered for three times per day for agitation.  Simethicone was also ordered for everyday for abdominal gas and polyethylene glycol was ordered daily for constipation.  Motrin® (ibuprofen) and Tylenol® (acetaminophen) were ordered for discomfort (pain).  CMS Ex. 14 at 3-4.  The evidence shows that discomfort (pain), abdominal gas, and constipation may cause agitation/irritability.  CMS Ex. 35 at 29, 47.  Dr. Brook also testified that Resident 45’s tracheostomy and ventilator are abnormal stimulus that could cause agitation.  Tr. 135-37.  On April 11, 2018, a new order for Seroquel® (quetiapine) was issued that provided for administration every six hours PRN for agitation/irritability up to two times per day following clonidine and Ativan® (lorazepam).  CMS Ex. 14 at 4.  I infer the physician intended administration of Seroquel® (quetiapine) if administration of clonidine and then Ativan® (lorazepam) were not effective to control agitation and/or irritability.

Resident 45’s medication regime from April 2018 through August 2018 is reflected by Petitioner’s MARs for her for that period.

April 2018 MARs list an undated order for a maintenance dose of Seroquel® (quetiapine), 6.25 mg by feeding tube three times per day for agitation.  The medication was administered every day in April except April 1 and 2, when Resident 45 was at Children’s.  A PRN order for Seroquel® (quetiapine) 6.25 mg by feeding tube every hour but no more than four times per day for agitation/irritability is listed as discontinued.  CMS Ex. 20 at 18.  I consider the discontinuation of the PRN dose of Seroquel® (quetiapine) to be a wean from the PRN dose.  There was a prescription for Ativan® (lorazepam), 0.2 mg via feeding tube every six hours PRN for agitation or irritability, which does not appear to have been administered during April 2018, except on April 11, 2018.  There was also a prescription for a maintenance dose of Ativan® (lorazepam) 0.3 mg by

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feeding tube every four hours that was administered every day in April except April 2 and 3, 2018 when Resident 45 was at Children’s.  CMS Ex. 20 at 19-20.  The MAR lists a hand-written and undated order for clonidine by feeding tube every eight hours for agitation/irritability that was administered 10 times in April 2018.  CMS Ex. 20 at 21; P. Ex. B at 1.  A note on the April MAR indicates that clonidine is supposed to be tried for agitation before Ativan® (lorazepam) is used.  CMS Ex. 20 at 23.  Another note indicates that Seroquel® (quetiapine) 6.25 mg may be administered PRN up to two times per day after clonidine and Ativan® (lorazepam) are administered (I infer after they are administered without effect).  CMS Ex. 20 at 16.  Simethicone for gas, polyethylene glycol for constipation, gabapentin for spasticity, are also listed as medications.  CMS Ex. 20 at 18, 19, 21.

May 2018 MARs list an April 3, 2018 prescription for a maintenance dose of Seroquel® (quetiapine) 6.25 mg by feeding tube three times per day for agitation.  This prescription was administered every day in May according to the MAR.  CMS Ex. 20 at 10.  The MAR lists an April 11, 2018 prescription for Seroquel® (quetiapine) 6.25 mg by feeding tube every six hours PRN, up to two times per day, for agitation/irritability after clonidine and Ativan® (lorazepam) have, I infer, been ineffective.  The PRN Seroquel® (quetiapine) was not administered in May according to the MAR.  CMS Ex. 20 at 2.  I note that the PRN order for Seroquel® (quetiapine) is for a less frequent dose than was discontinued in April 2018.  The MAR lists a prescription for clonidine by feeding tube every eight hours PRN for agitation/irritability, which was not administered in May.  CMS Ex. 20 at 2.  The MAR lists Ativan® (lorazepam) 2 mg by feeding tube every six hours PRN for agitation of irritability, which was not administered in May.  CMS Ex. 20 at 3.  The MAR also lists an April 3, 2019 order that PRN clonidine was to be administered before Ativan® (lorazepam) (I infer the PRN Ativan® (lorazepam)).  CMS Ex. 20 at 6.  The MAR lists a maintenance dose of Ativan® (lorazepam), 3 mg by feeding tube every four hours for agitation/irritability, which was administered every day in May 2018.  CMS Ex. 20 at 8.  The MAR also lists gabapentin for spasticity; a suppository and enema for constipation, Tylenol® (acetaminophen) and Motrin® (ibuprofen) for fever or discomfort, simethicone for gas, and polyethylene glycol for constipation.   CMS Ex. 20 at 2, 9, 10.

June 2018 MARs list the April 3, 2018 order for the maintenance dose of Seroquel® (quetiapine), 6.25 mg by feeding tube three times per day for agitation, which was administered every day in June 2018.  CMS Ex. 20 at 38.  The MAR lists the April 11, 2018 order for Seroquel® (quetiapine), 6.25 mg by feeding tube every six hours PRN for agitation/irritability, but no more than two doses per day and only after PRN clonidine and PRN Ativan® (lorazepam) were used.  No doses of PRN Seroquel® (quetiapine) are recorded in June 2018.  CMS Ex. 20 at 50.  The MAR lists the April 3, 2018 order for the maintenance dose of Ativan® (lorazepam) 2 mg by feeding tube every four hours for agitation/irritability that

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was administered every day in June 2018.  CMS Ex. 20 at 42.  The MAR also lists the April 3, 2018 order for Ativan® (lorazepam), by feeding tube every six hours PRN for agitation/irritability, which was administered once in June 2018.  CMS Ex. 20 at 49, 52.  The MAR lists the April 3, 2018 order for clonidine by feeding tube every eight hours PRN if blood pressure is greater than 80/50, for agitation/irritability.  CMS Ex. 20 at 50.  The MAR lists an April 3, 2018 order that PRN clonidine should be administered before Ativan® (lorazepam) (PRN I infer).  CMS Ex. 20 at 44.  The MAR also lists gabapentin for spasticity, simethicone for gas, polyethylene glycol, enema, and suppository for constipation, PRN Tylenol® (acetaminophen) and PRN Motrin® (ibuprofen) for fever or discomfort.  CMS Ex. 28 at 38, 40, 49, 50-51.

July 2018 MARs list the April 3, 2018 order for a maintenance dose of Seroquel® (quetiapine) 6.25 mg by feeding tube three times per day for agitation, which was administered every day in July 2018.  CMS Ex. 20 at 55.  The MAR lists the April 11, 2018 order for Seroquel® (quetiapine) for agitation/irritability, by feeding tube every six hours PRN, up to twice per day, after PRN clonidine and PRN Ativan® (lorazepam), but no administrations of the medication are noted in July.  The July MAR lists a maintenance dose of Ativan® (lorazepam) by feeding tube every four hours for agitation/irritability that was administered every day in July.  CMS Ex. 20 at 57.  The MAR lists an April 3, 2018 order for Ativan® (lorazepam) by feeding tube every six hours PRN for agitation/irritability, that was administered once in July 2018.  CMS Ex. 20 at 61.  An April 3, 2018 order required clonidine by feeding tube every eight hours PRN for agitation/irritability.  CMS Ex. 20 at 62.  The July MAR lists the direction that PRN clonidine be administered before Ativan® (lorazepam) (PRN I infer).  CMS Ex. 20 at 58.  The nurses’ medication notes for the July 2018 MAR states that PRN Ativan® (lorazepam) was administered for high heart rate and irritability on July 8, 2019; PRN Seroquel® (quetiapine) was administer on July 21, 2018 for high heart rate; and PRN clonidine was administered on July 27, 2018 for agitation, high heart rate, and crying.  All administrations were reported to be effective at lowering Resident 45’s heart rate and calming her.  None of the notes state why on July 8 and July 21, 2018, the order to give PRN clonidine first was not followed.  CMS Ex. 20 at 64.  The July 2018 MAR lists gabapentin and baclofen for spasticity; simethicone for gas; polyethylene glycol, glycerin suppository, and enema for constipation; Tylenol® (acetaminophen) and Motrin® (ibuprofen) for fever or pain.  CMS Ex. 20 at 55-56, 61-62.

August 2018 MARs list the April 3, 2018 order for the maintenance dose of Seroquel® (quetiapine) three times per day by feeding tube for agitation that was recorded as being administered every day through August 8 and two times on August 9, 2018.  I infer that August 9, 2018, the date of the last entries on the form, was the date this copy of the MAR was made for the surveyor.  CMS Ex. 20

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at 65.  The MAR lists the April 3, 2018 order for the maintenance dose of Ativan® (lorazepam) by feeding tube every four hours for agitation/irritability that was administered every day in August 2018 through August 9, 2018.  CMS Ex. 20 at 67.  The MAR also lists the April 3, 2018 order for Ativan® (lorazepam) by feeding tube every six hours PRN for agitation/irritability.  No administrations of the PRN Ativan® (lorazepam) are noted.  CMS Ex. 20 at 71.  The August 2018 MAR lists the April 11, 2018 order for Seroquel® (quetiapine) by feeding tube every six hours PRN for agitation/irritability, up to twice per day, after PRN clonidine and PRN Ativan® (lorazepam) have been used.  The MAR lists the April 3, 2018 order for clonidine by feeding tube every eight hours PRN for agitation/irritability.  CMS Ex. 20 at 72.  The August 2018 MAR lists the direction to give PRN clonidine before PRN Ativan® (lorazepam).  CMS Ex. 20 at 68.  The August 2018 MAR also lists orders for gabapentin and baclofen for spasticity; simethicone for gas; polyethylene glycol, glycerin suppository, and enema for constipation; Tylenol® (acetaminophen) and Motrin® (ibuprofen) for fever or pain.  CMS Ex. 20 at 65-66, 71-73.  The August 2018 MAR for the period August 1 through 9, 2018, notes no administration of PRN Ativan® (lorazepam), clonidine, or Seroquel® (quetiapine).

The MARs for April through August 2018, show that maintenance doses of Seroquel® (quetiapine) and Ativan® (lorazepam) were given as ordered.  However, PRN doses of the two medications were used infrequently during the period.  The forms show that there was an attempt to wean or taper the use of Seroquel® (quetiapine) by reducing the frequency of the PRN dose and by using the non-psychotropic clonidine first followed by PRN Ativan® (lorazepam) before a PRN dose of Seroquel® (quetiapine) was administered.  Although the MARs may show a deviation from orders on one occasion, Petitioner was not cited for a medication error related to that instance.

**Specific Allegations of Noncompliance**

Having reviewed Resident 45’s medical history, we turn to the allegations of noncompliance of the surveyors and CMS.

**(1)  42 C.F.R. § 483.45(e)(1) requires**

Residents who have not used psychotropic drugs are not given these drugs unless the medication is necessary to treat a specific condition as diagnosed and documented in the clinical record;

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**(2)  42 C.F.R. § 483.45(e)(3) requires**

Residents do not receive psychotropic drugs pursuant to a PRN order unless that medication is necessary to treat a diagnosed specific condition that is documented in the clinical record;

**Surveyor Allegation:  Resident 45 had no documented history of psychosis.  CMS Ex. 1 at 71-72.**

**Surveyor Allegation:  Resident 45, was under 10 years old and Seroquel® (quetiapine) is not approved for use in a child under 10 years old.  CMS Ex. 1 at 72.**

**CMS Allegation:  Petitioner administered Seroquel® (quetiapine) and Ativan® (lorazepam) in ways not contemplated by the manufacturer or the FDA.  CMS Br. at 8.**

It is correct that Resident 45 had no documented history of psychosis.  Ilanit Brook, M.D., Associate Professor of Pediatrics and Anesthesiology at the University of Southern California Kech School of Medicine and Director of Hospice and Palliative Medicine at Children’s was called to testify by Petitioner.  Tr. 125.  I find Dr. Brook’s testimony credible and weighty based on her knowledge of Resident 45 and her expertise.17

Dr. Brook testified that she was part of the team of physicians and consultants at Children’s that provided care for Resident 45.  Tr. 126.  She identified the following Children’s departments or disciplines as participating in the care of Resident 45:  pulmonary medicine, neurology, pediatrics, palliative medicine, gastroenterology,

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orthopedics, endocrinology, and cardiology.  Her department was palliative care which focused on keeping a patient with a life-limiting or life-threatening illness such as Resident 45 as comfortable as possible.  Tr. 126-27.  She explained that Resident 45 first arrived at Children’s as a baby, and she was in the neonatal care intensive care unit.  After Resident 45 went to Petitioner, the Children’s team continued to provide services in consultation with her care team at Petitioner.  The team at Children’s had access to Petitioner’s electronic records for Resident 45 and at least some of the team at Petitioner had access to records at Children’s.  Both Children’s records and Petitioner’s records would be used by the IDT when care planning for Resident 45.  She explained that physicians who see patients at Petitioner are also faculty and physicians at Children’s and they have access to their records at either facility.  Also, fellows at Children’s are required to spend time at Petitioner rounding with Dr. Sally Ward. 18  Tr. 128, 170-71, 181.  Dr. Brook explained that Resident 45 was not prescribed Ativan® (lorazepam) and Seroquel® (quetiapine) for psychosis.  She testified that Resident 45 will never be verbal, and it was not possible to diagnose her with psychosis and it was unlikely that she had psychosis.  Tr. 141-42, 198.

There is no dispute that Resident 45 was under 10 years old.  There is also no dispute that both Ativan® (lorazepam) and Seroquel® (quetiapine) were used for Resident 45 in ways not recommended, suggested, or evaluated by the manufacturer of those drugs.  However, an assertion that the FDA has not approved the use of Seroquel® (quetiapine) for children under 10 years old is misleading.  An excerpt of the Pediatric Dosing Handbook and Formulary from Children’s placed in evidence by CMS, indicates that the usual dose for a child less than 12 years old is 12.5 mg per day and does not specify that that dose may not be used for child under 10 years old or younger.  CMS Ex. 30 at 2.  The full prescribing information for Seroquel® (quetiapine) placed in evidence by CMS also does not state the medicine may not be prescribed for children under 10 years old.  Rather, the evidence indicates that the safety and effectiveness of Seroquel® (quetiapine) for certain conditions in pediatric patients of less than certain ages has not been established.  CMS Ex. 39 at 27, 49.  CMS does not raise an issue related to prescribing Ativan® (lorazepam) for pediatric patients.  The evidence submitted by CMS states that long-term use of Ativan® (lorazepam) for more than four months has not been assessed and physicians should periodically assess the usefulness of the medicine for the individual patient.  CMS

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Ex. 39 at 1.  The evidence does not include specific precautions for pediatric use of Ativan® (lorazepam).  CMS Ex. 39 at 3.

Dr. Brook testified that for her pediatric patients in 2018, it was not unusual to use psychotropics for palliative care.  Use of Ativan® (lorazepam) and Seroquel® (quetiapine) for pediatric patients is off-label19 use.  She explained that there is no prohibition on doctors using drugs off-label.  Tr. 149-50.  On cross-examination, Dr. Brook testified that using drugs when possible, according to instructions of the FDA and manufactures, was standard of care.  She testified that she was familiar with the black box warnings for Ativan® (lorazepam) and Seroquel® (quetiapine) and that there were no instructions for giving the drugs to children under 10 years of age.  She believed that instructions for Ativan® (lorazepam) indicted the medicine should not be used for more than four weeks.  However, she clarified that safety and efficacy of using the drugs as they were with Resident 45 was shown by standard of care and pediatric practitioners as published in professional journal articles and poster presentations or presentations at national conferences.  She could not recall or cite any specific article that established the safety and efficacy of use of Seroquel® (quetiapine) or Ativan® (lorazepam) for a child under two years of age or for a period of three or four months.  Tr. 195-98.  However, I do not find that her inability to recall specific article undermines her credibility, understanding that it is not reasonable to expect physicians to recall every piece of scientific research regarding medications prescribed to their patients.

**Surveyor Allegation:  The surveyors found no consistent indication for the use of Ativan® (lorazepam) and Seroquel® (quetiapine).  CMS Ex. 1 at 72. **

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**Surveyor Allegation:  The surveyors found no documented behaviors that supported the administration of either medication.  CMS Ex. 1 at 72. **

**CMS Allegation:  Petitioner administered psychotropic drugs to Resident 45 that were not necessary to treat a specific condition that was diagnosed and documented in the clinical record in violation of 42 C.F.R. § 483.45(e)(1).  CMS Br. at 5; CMS Reply at 2-3. **

The evidence of record shows that these allegations are unfounded.

Surveyor Ekeomodi testified that based on her review of the physician’s order dated April 3, 2018, Resident 45’s physician prescribed Seroquel® and Ativan® for agitation or irritation.  Tr. 258-259.  Based on her experience as a pharmacist, she opined that agitation is a very vague term and can be any type of movement that causes discomfort or inability to sit or stay still.  Tr. 259, 323.  Restlessness is also a very general term which means an inability to sit still.  Irritability is also a general term something causing the baby to not easily be comforted or relaxed.  Tr. 259-260.  However, during cross-examination, she stated that "agitation is considered a diagnosis but it’s kind of general" and confirmed again that agitation is a diagnosis.  Tr. 329-330.  She also testified that Seroquel® (quetiapine) is an antipsychotic medication used to treat mental disorders, usually used to treat patients with a diagnosis of schizophrenia, dissociation from reality, or a form of severe manic depression.  Tr. 260.  Upon my questioning, Surveyor Ekeomodi agreed that the use of Ativan® (lorazepam) and Seroquel® (quetiapine) for Resident 45 was an off-label use.  As shown in her surveyor notes, she had discussed the off-label use with Dr. Sally Ward, who stated the off-label use of Ativan® (lorazepam) and Seroquel® (quetiapine) for Resident 45 was appropriate.  Tr. 335-337; CMS Ex. 7 at 27.  In her notes, she wrote that Dr. Ward told her that in pediatrics, drugs are often used for off-label purposes.  CMS Ex. 7 at 28.  I also referred Surveyor Ekeomodi to Pediatric Sub-Unit Progress Notes (CMS Ex. 22), which list agitation as an acute diagnosis, and Surveyor Ekeomodi then confirmed neuro-agitation was a diagnosis.  Tr. 375.

The evidence shows that Resident 45 was prescribed Ativan® (lorazepam) and Seroquel® (quetiapine) as well as several non-psychotropic medications for the diagnosis of agitation and restlessness.  Agitation and restlessness is listed in the International Classification of Diseases (ICD)20 under diagnosis code R45.1, which shows that

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agitation and restlessness is a recognized disease or condition.  CMS Ex. 13.  Dr. Brook testified that agitation is a clinical diagnosis, but it is connected to more than one condition. 21  Tr. 186.

Contrary to the allegations of the surveyors and CMS, Children’s documents and Petitioner’s documents in evidence show that Resident 45 had multiple diagnoses that had specific signs and symptoms for which Ativan® (lorazepam) and Seroquel® (quetiapine) were prescribed for Resident 45.  Copies of records from various departments of Children’s from the period June 9, 2017 (shortly after Resident 45’s admission to Petitioner) through March 6, 2017, show problems and diagnoses addressed as basis for continuing problems with agitation and irritability, including dysautonomia (CMS Ex. 35 at 3), seizures, autonomic storm, spasticity, neuro-agitation and neuro-irritability secondary to extensive cystic encephalomalacia with neurologic devastation (CMS Ex. 35 at 1-4, 9-10, 129), bradycardia due to her dysautonomia resulting from her neurologic devastation, and hypotension (CMS Ex. 35 at 1-10, 52-89), "neuro-agitation and neuro-irritability secondary to extensive cystic encephalomalacia with neurologic devastation" (CMS Ex. 35 at 129).  When she was discharged from Children’s on April 3, 2018, Resident 45’s discharge diagnosis was dysautonomia.  CMS Ex. 35 at 11.  Her discharge summary listed acute diagnoses including sepsis, hypothermia, bradycardia, adrenal insufficiency, chronic respiratory failure, ventilatory dependence, and agitation.  CMS Ex. 23 at 3; CMS Ex. 35 at 90.  Petitioner’s admission record for Resident 45 on April 3, 2019, lists restlessness and agitation.  CMS Ex. 13.  Petitioner’s physician order sheets for Resident 45 show that Seroquel® (quetiapine) was prescribed for agitation, gabapentin was prescribed for spasticity, simethicone was prescribed for abdominal gas, polyethylene glycol was prescribed for constipation, Ativan® (lorazepam) was prescribed for agitation/irritability, clonidine was prescribed for agitation/irritability, a pediatric glycerin suppository and enema were prescribed for constipation, and her feeding tube was to be vented continuously to prevent abdominal distention.  CMS Ex. 14 at 3-8.  Dr. Ward’s order on March 6, 2018, reflected that Seroquel® (quetiapine) was prescribed for neuro-agitation.  CMS Ex. 14 at 9.  Dr. Brook testified that Resident 45 suffered from both dysautonomia (indicated by agitation and abnormal vital signs) and neuro-agitation and maintenance doses and PRN doses of both Ativan® (lorazepam) and Seroquel® (quetiapine) were necessary to manage Resident 45.  Tr. 144-46, 165-66.  Dr. Brook testified that neuro-agitation means the brain is not reacting normally to stimulus and the brain is agitated – which she explained may not the best word but is commonly

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understood in the medical field.  She explained that both Resident 45’s tracheostomy and ventilator are abnormal stimulus that could cause agitation that the resident had to cope with.  Tr. 135-37.  Resident 45 also suffered seizures that caused her to be hospitalized in 2018.  Tr. 137.  June 12, 2018 Interdisciplinary Team Meeting/Care Plan Meeting Notes show that Resident 45 received Seroquel® (quetiapine) three times per day for agitation, simethicone four times per day for gas, polyethylene glycol every day for constipation, Tylenol® (acetaminophen) needed for fever/discomfort, and Ativan® (lorazepam) twice a day for agitation.  CMS Ex. 27.

CMS argues that "[d]espite an absence of the symptoms for which [Seroquel® (quetiapine)] was prescribed, [Petitioner’s] apparent plan was to indefinitely keep a toddler on psychotropic medication without evaluation."  CMS Br. at 12.  CMS argues, selectively relying upon the evidence, that behavioral interventions (holding and rocking) could be successfully used to address the resident’s agitation.  CMS says the evidence "strongly suggests that the dose and/or frequency of the use of prescribed psychotropics could have been reduced or eliminated" using comfort measures alone.  CMS Br. at 12.  CMS advances these arguments ignoring the fact that Resident 45’s physicians prescribed her medication not Petitioner.  CMS also ignores the Children’s records related to Resident 45’s hospitalization and treatment.  The Children’s records show that Resident 45’s agitation and dysautonomia consistently responded to being held and rocked as stated by CMS.  However, CMS overlooks the fact that the record shows that Resident 45 still became agitated one to two times per day with increased heartrate and her PRN medications (I infer her psychotropics and pain medication) were necessary with nonpharmacologic interventions such as holding, bathing, and rocking to calm her.  Psychiatry recommended increasing Resident 45’s Seroquel® (quetiapine) because she had increased agitation (dysautonomia) during March 2018, the month her Seroquel® (quetiapine) was reduced to only twice per day.  CMS Ex. 35 at 22-23, 42, 91, 93-94.

CMS also fails to recognize that, upon discharge on April 3, 2018, the attending physician for Resident 45 with Children’s Division of Comfort and Palliative Care, sent Lindsay Barr (possibly a nurse practitioner or physician’s assistant) and Dr. Sally Ward an email informing them that Resident 45 was returning to Petitioner.  This document was placed in evidence by CMS, and I have no reason to question its authenticity or credibility or to discount its weight as evidence.  The email included recommendations for symptom management including:  increasing Ativan® (lorazepam) to every four hours around the clock; using clonidine as the first-line for agitation if blood pressure is greater than 80/50; Ativan® (lorazepam) every six hours PRN as a second-line for agitation; and continuing Seroquel® (quetiapine) twice per day but with a "low threshold" to increase to three times per day because the attempt to wean Resident 45 caused the increase in her dysautonomia over the past month.  The email also alerted Dr. Ward and Petitioner’s staff to other possible triggers for the residents’ agitation.  The email recommended that Petitioner was to continue Resident 45’s bowel regime to allow a soft bowl movement every day because constipation can be a cause of agitation; and

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cautioned that overfeeding may also cause worsening of agitation.  The email also informed Petitioner’s staff that Resident 45 would have future appointments in Children’s palliative care clinic for symptom management rather than in the pain clinic.  CMS Ex. 35 at 29, 47.

The evidence shows continuing evaluation by Petitioner’s staff and the resident’s physicians, adjustments in Resident 45’s medication, and the use of behavioral interventions – evidence that is ignored by CMS.  The evidence shows that despite various interventions, Resident 45 continued to suffer agitation and/or irritability in April 2018.

Petitioner’s "24 Hour Nursing Flowsheets" (nursing flowsheets) for Resident 45 document ongoing agitation and/or irritability after her readmission to Petitioner on April 3, 2018.

A nursing flowsheet entry on April 7, 2018, at 8:00 a.m. shows Resident 45’s heart rate was in the 160’s, she was agitated and crying.  Ativan® (lorazepam) was given and she was repositioned.  At 10:50 a.m. PRN clonidine was given, and the resident was repositioned.  At 11:20 a.m. the clonidine was noted to be effective as Resident 45 was calm and sleeping with a heart rate of 79.  CMS Ex. 29 at 83.

A nursing note on April 11, 2018, at 6:30 a.m. indicates Resident 45 was agitated and crying with a heart rate in the 170s.  The note states the resident was repositioned and comfort measures were attempted.  PRN clonidine was subsequently administered.  P. Ex. K at 4, CMS Ex. 29 at 90.  A nursing flowsheet entry at 8:10 a.m. on April 11, 2018, shows Resident 45 remained agitated with her heart rate in the 170s so she was given PRN Ativan® (lorazepam).  CMS Ex. 29 at 90.  A nursing narrative notes dated April 11, 2018, at 9:00 a.m., indicates that the PRN Ativan® (lorazepam) was ineffective and Resident 45’s heart rate continued to be in the 150’s and staff was going to monitor the situation.  At 11:00 a.m. the resident was noted to have no signs of distress.  At 1:00 p.m. she was noted to be calm in her mother’s arms.  At 6:30 p.m. Resident 45 was agitated with an increased heart rate and clonidine PRN was administered.  The note indicates that Seroquel® (quetiapine) every hour PRN was discontinued with a new order for Seroquel® (quetiapine) every six hours PRN up to twice per day and after PRN clonidine and PRN Ativan® (lorazepam) were used.  P. Ex. A at 20; CMS Ex. 29 at 147.

A nursing flowsheet entry on April 12, 2018, at 6:30 a.m. shows that Resident 45 was crying and agitated with a heart rate in the 170s.  She was repositioned and given clonidine, which appears to have been effective as at 7:00 a.m. she was reported to be calm and in no distress.  CMS Ex. 29 at 148.  A nursing note at 9:00 a.m. reported that Resident 45 had discomfort and increased heart rate with crying.

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Repositioning and comfort measurers were effective to calm her.  P. Ex. K at 5.  However, at noon on April 12, 2019, Resident 45’s heart rate ranged from 168 to 190 and she was repositioned for comfort.  At 1:00 p.m. she was given PRN clonidine for agitation.  At 8:00 p.m. she was again noted to be agitated with heart rate of 140.  Her routine prescription for Ativan® (lorazepam) was administered and she was repositioned.  At 10:00 p.m. Resident 45 was noted to be asleep with no signs or symptoms of pain or agitation.  CMS Ex. 29 at 94; P. Ex. K at 5.

The evidence shows that on April 18, 2018, one of Petitioner’s RNs spoke with one of Resident 45’s physicians at Children’s.  Petitioner’s RN explained that Resident 45 initially did well following her April 3, 2018 discharge from Children’s.  However, Resident 45 subsequently had increased agitation and all her PRN medication was needed to address the agitation.  Petitioner’s RN requested an order for an additional dose of quetiapine (Seroquel®) PRN after all other PRN medications were exhausted.  The RN reported no signs or symptoms of illness or other reason for agitation.  The Children’s physician agreed to the additional PRN dose, but no more than two doses per day.  The physician noted that Resident 45 remained responsive to handling by her mother and noted a need to evaluate other reasons for agitation and possible interventions.  The note also indicated that the Children’s physician wrote to Dr. Ward and Petitioner’s nurse practitioner so that they could write an order in Petitioner’s system.  CMS Ex. 35 at 122.

On April 30, 2018, at 6:30 p.m. the nursing notes indicate that clonidine was given for agitation and heart rate in the 170s.  P. Ex. A at 21; CMS Ex. 29 at 100.

Contrary to the CMS argument (CMS Br. at 12), the evidence shows that Resident 45 also continued to suffer agitation in May 2018.

On May 10, 2018, Resident 45 was seen in the Children’s Pain and Palliative Care Center.  CMS Ex. 34 at 10-14; CMS Ex. 35 at 48-51, 123-128.  The summary of the consultation states that since her last discharge from the hospital Resident 45 had fewer episodes of agitation and indicates that the episodes of agitation were resolved with holding and no use of PRN clonidine, Ativan® (lorazepam), or Seroquel® (quetiapine).  This statement is inconsistent with the nurse’s notes from April 2018 and other evidence. The summary of the consultation reports that one of Petitioner’s RNs who cared for Resident 45 reported that Resident 45 had only rare episodes of agitation that resolved with holding or no intervention.  However, the report of the RN is misleading and not accurate.  Resident 45 had orders for Ativan® (lorazepam) and Seroquel® (quetiapine) on both a daily basis for maintenance as well as PRN orders for both when her agitation increased.  In fact, the note indicates that her regular order for Seroquel® (quetiapine) had recently been changed back to three times per day and that had caused further decrease in Resident 45’s agitation.  CMS Ex. 34 at 10; CMS Ex. 35 at 123

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Her prescriptions included lorazepam (Ativan®) every four hours and every six hours PRN for agitation/irritability; quetiapine (Seroquel®) three times per day and PRN every hour for agitation/irritability, and simethicone four times per day PRN for agitation/irritability.  CMS Ex. 35 at 49-50, 124-25.  Even though PRN psychotropics may have been less necessary in April 2018 than they were in March 2018, Resident 45 continued to receive her maintenance doses of Ativan® (lorazepam) and Seroquel® (quetiapine), which more likely than not, considering all the prior efforts at control, aided in controlling her agitation and irritation.

The evidence shows that Resident 45 continued to suffer from agitation and/or irritability in June and July 2018.

Nursing flowsheets show that on June 1, 2018, at 1:00 p.m. Resident 45 was agitated and comfort measures were used to calm her.  CMS Ex. 29 at 106.  Nursing narrative notes from June 13, 2018, at 10:00 a.m. record that Resident 45’s heart rate had increased to the range of 160 to 170 beats per minute, she was in discomfort as manifested by her crying and flushed face.  She was repositioned and cooling measures were implemented.  According to a note at 10:30 a.m. her heart rate decreased, and she stopped crying.  A note at 11:00 a.m. states her heart rate was increased to 170, she was crying.  Cooling measures were used again.  However, at 11:25 a.m. Resident 45 continued to cry and her heart rate was ranging from 170 to 180.  Resident 45 was repositioned and PRN Ativan® (lorazepam) was administered.  There is no indication why PRN clonidine was not administered first.  Resident 45 was reported to be calm and her heart rate had dropped to 130 to 140 at Noon.  P. Ex. K at 8.

On June 25, 2018, Resident 45 was seen in the Children’s Endo-Metabolism Department for follow-up.  Her medications listed included lorazepam (Ativan®) every four hours for maintenance and every six hours PRN for agitation/irritability; quetiapine (Seroquel®) three times per day for maintenance and PRN every hour for agitation/irritability, and simethicone daily and PRN for agitation/irritability. CMS Ex. 35 at 248-50.

On July 8, 2018, nurse notes at 2:00 a.m. report that Resident 45 was awake, irritable, and agitated.  At 6:00 a.m. she was given PRN Ativan® (lorazepam) due to her agitation and heart rate of 192.  The PRN Ativan® (lorazepam) was reported to be effective at 7:00 a.m.  There is no indication why PRN Ativan® (lorazepam) was given before clonidine.  P. Ex. K at 10.

On July 27, 2018, at 1:00 p.m., Resident 45 was noted to be crying and agitated with heart rate ranging from the 180s to 200s.  PRN clonidine was given which appears to have been effective as at 1:45 a.m. the resident was calm with a heart rate of 117.  CMS Ex. 29 at 112.

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The nursing notes and nursing flowsheets clearly show that Petitioner used the non-psychotropic medication clonidine and comfort measures to manage Resident 45’s agitation after her readmission to Petitioner on April 3, 2018, in addition to Ativan® (lorazepam) and Seroquel® (quetiapine).

Petitioner’s Psychopharmaceutical Summary Sheets for Resident 45 show that she was given Ativan® (lorazepam), Seroquel® (quetiapine), and clonidine for neuro-agitation, agitation and irritability, and agitation manifested by tachycardia and tachypnea.  Resident 45 required no PRN dose of Seroquel® (quetiapine) in April, May, and June 2018, but she required one dose in July 2018, and it was effective in addressing Resident 45’s agitation/irritability.  CMS Ex. 26 at 4.  Petitioner’s records show that she continued to receive the maintenance dose of Seroquel® (quetiapine) during April, May, June, and July 2018.  CMS Ex. 26 at 3.  The summary sheets show that PRN Ativan® (lorazepam) was administered for agitation or irritation one time in April 2018, one time in June 2018, and one time in July 2018, with no administration in May 2018, with Resident 45 receiving her maintenance dose throughout the period.  CMS Ex. 26 at 1-2.  CMS cites Petitioner’s Psychopharmaceutical Summary Sheets at CMS Ex. 26 in support of its argument that Resident 45 experienced no episodes of agitation for three months prior to the survey.  CMS Br. at 12.  However, documents in CMS Ex. 26 show that, despite her maintenance doses of psychotropics, Resident 45 required PRN doses of Ativan® (lorazepam) and/or Seroquel® (quetiapine) in April, June, and July 2018, for agitation or irritation.  Therefore, the CMS argument that Resident 45 had shown no symptoms of agitation for three months (CMS Br. at 12) is clearly incorrect.

Dr. Brook explained that in August 2018, Resident 45 required both Seroquel® (quetiapine) and Ativan® (lorazepam) in a maintenance dose and a PRN dose, because the drugs work on different brain receptors.  Resident 45 was also receiving other drugs to act on additional brain receptors.  The goal was to keep the brain calm despite stimulus while keeping Resident 45 awake.  The PRN doses were necessary to address agitation when Resident 45 was awake.  Using the PRN dose allowed the maintenance dose to be lower and keep the resident awake.  She testified that if a PRN dose was used, the reason should be documented.  Tr. 142-44.  Dr. Brook testified that dysautonomia is abnormal autonomic system response.  Dysautonomia is like neuro-agitation –  the latter term normally used when talking with families.  Dysautonomia is generally indicated by agitation and abnormal vital signs and for Resident 45 when these events occurred they were life-threatening.  Tr. 144-46.  She testified that Resident 45 suffered from both dysautonomia and neuro-agitation and both Ativan® (lorazepam) and Seroquel® (quetiapine) as a maintenance dose and PRN dose, were necessary to handle those conditions.  Tr. 165-66.

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**Summary**

I find that Resident 45 had specific diagnoses documented in her medical record, including neuro-agitation, dysautonomia, agitation and/or irritation and various other diagnosed conditions that could cause agitation and/or irritation, for which she was prescribed maintenance and PRN doses of Seroquel® (quetiapine) and Ativan® (lorazepam).

Accordingly, I conclude that, contrary to the allegations of the surveyors and CMS there was no violation of 42 C.F.R. § 483.45(e)(1) and (3).

**(3)  42 C.F.R. § 483.45(e)(2) requires**

Residents who use psychotropic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs;

**Surveyor Allegation:  The surveyors found no documentation of the use of nonpharmacological interventions.  CMS Ex. 1 at 72. **

**CMS Allegation:  Petitioner failed to attempt behavioral interventions in an effort to discontinue Seroquel® (quetiapine) and Ativan® (lorazepam).  CMS Br. at 9; CMS Reply at 2.  **

**CMS Allegation:  Petitioner failed to attempt any gradual dose reductions of Resident 45’s psychoactive medication, despite evidence that it could be successful.  CMS Br. at 12; CMS Reply at 2, 5. **

The allegations are contrary to the evidence and without merit.

A cautious reading of the allegations is necessary in order not to be misled.  CMS alleges that Petitioner failed to attempt behavioral interventions22 and failed to attempt gradual

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dose reductions (weaning or tapering).  However, Petitioner cannot issue orders for a resident to receive psychotropics, to implement behavioral interventions in lieu of psychotropics, or weaning (eliminating or reducing psychotropics) as those orders must be issued by a resident’s physicians.  The evidence also shows that weaning and behavioral interventions were used many times with Resident 45.23

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Petitioner’s medical record for Resident 45 contains evidence of attempts to wean Resident 45 off Ativan® (lorazepam) and Seroquel® (quetiapine) as well as narcotics and other drugs used to help control her agitation.

The evidence shows that from her first admission to Petitioner on May 30, 2017, to her readmission to Petitioner on April 3, 2018, Resident 45 was seen by physicians in various departments of Children’s, either as an inpatient or outpatient, every month except December 2017.  The evidence shows that physicians at Children’s were actively engaged in managing Resident 45’s medications to find the right combinations of drugs to control her agitation and irritability, whether the agitation and irritability was caused by pain, seizure activity, autonomic storm, spasticity, overfeeding, gas, or some other cause.

Resident 45 was weaned off methadone (an opioid/narcotic) for pain at least twice between May 30, 2017 and April 3, 2018.  Weaning her from methadone caused her to be given Dilaudid® (hydromorphone) (an opioid/narcotic).

In June 2017, it was noted that Resident 45’s physician ordered Ativan® (lorazepam) and that was beneficial as she was no longer agitated but remained responsive.  CMS Ex. 35 at 159.  In June 2017, she was receiving Dilaudid® (hydromorphone), Ativan® (lorazepam), and simethicone all prescribed for agitation and irritability.  CMS Ex. 35 at 158-59.  The plan on June 9, 2017, was to continue to wean her off methadone and then wean her off Ativan® (lorazepam).  CMS Ex. 35 at 162-63.

On July 17, 2017, Resident 45 was still being weaned off methadone and required frequent doses of Dilaudid® (hydromorphone) to control her neuro-agitation.  She

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continued to receive Ativan® (lorazepam) and simethicone for agitation and irritability.  CMS Ex. 35 at 129, 143.

On August 29, 2017, Resident 45 was reported to be off methadone but being given Dilaudid® (hydromorphone) once or twice each day when inconsolable.  She continued to receive Ativan® (lorazepam) and simethicone for agitation and irritability.  CMS Ex. 35 at 164-65.

On September 18, 2017, Resident 45 was reported to require less Dilaudid® (hydromorphone) and she was being given gabapentin (typically used for seizure disorders), clonidine, Dilaudid® (hydromorphone), Ativan® (lorazepam), and simethicone to address her agitation.  The plan was to wean her off Ativan® (lorazepam) over seven weeks.  CMS Ex. 35 at 170-71, 173.  However, Petitioner’s nurses reported that issues with neuro-agitation continued while tapering off sedation and Resident 45 was not tolerating changes in her position and transfers, presumably due to pain.  CMS Ex. 35 at 221-22.  During the September 18, 2017 appointment, Resident 45 was noted to be extremely agitated and inconsolable.  The plan was to continue with prescribed medications and add interventional therapies and stretching and strengthening exercise.  CMS Ex. 35 at 222-24.

During her admission to Children’s in October 2017, Seroquel® (quetiapine) was added.

A November 20, 2017 report shows that Resident 45’s care giver reported some agitation lasting minutes to an hour without identifiable trigger; comfort measures usually worked, if not Tylenol® (acetaminophen) was given.  CMS 35 at 175.  Ativan® (lorazepam), Seroquel® (quetiapine), and simethicone were ordered in maintenance and/or PRN doses for the resident’s agitation/irritability.  CMS Ex. 35 at 175-76.  There was a plan to wean the resident off Ativan® (lorazepam) during the next four weeks, but due to her increased agitation PRN Ativan was authorized.  CMS Ex. 35 at 182.

On November 30, 2017, the Children’s Comfort and Palliative Care Clinic team was working on an Ativan® (lorazepam) wean.  CMS Ex. 35 at 141.

A January 10, 2018 report shows that Dilaudid® (hydromorphone) was being used for periods of agitation/irritability and it was recommended that the resident’s doses of gabapentin be increased to help with her agitation.  CMS Ex. 34 at 8; CMS Ex. 35 at 148-49.

On February 12, 2018, it was reported Resident 45’s agitation was an on-going concern, and that Resident 45 was being weaned off Dilaudid® (hydromorphone).

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A March 6, 2018, report shows that weaning Resident 45 to less frequent use of Seroquel® (quetiapine) was recommended with monitoring of Ativan® (lorazepam) use.  CMS Ex. 35 at 20.

Resident 45 was readmitted to Children’s on March 26, 2018, and she was discharged on April 3, 2018.  CMS Ex. 23 at 3-6; CMS Ex. 35 at 11-14, 90-122, 183-204.  According to her discharge and transfer summary, her discharge diagnosis for that admission was dysautonomia.  CMS Ex. 35 at 11.  It is noted that Resident 45’s agitation and dysautonomia consistently responded to being held and gently rocked.  However, she still became agitated one to two times per day with increased heartrate but her PRN medications and interventions such as holding, bathing, and rocking calmed her down.  Psychiatry recommended increasing her Seroquel® (quetiapine) to three times per day because she had increased agitation during the month her Seroquel® was reduced to twice per day.  The new medication regime recommended by the palliative care team included Ativan® (lorazepam) every four hours; clonidine every eight hours as the first treatment for agitation/irritability, Ativan® (lorazepam) PRN every six hours as a second-line treatment for agitation/irritability; and increasing Seroquel® (quetiapine) administered to three times per day (because the recent attempt to wean Resident 45 had caused increased dysautonomia over the past month) and every hour PRN for agitation/irritability.  CMS Ex. 35 at 22-23, 29, 42, 47, 91, 94-95.

The surveyors and CMS fail to recognize that tapering or weaning of Seroquel® (quetiapine) was also ordered on April 11, 2018.  A new order required that Seroquel® (quetiapine) could be given PRN every six hours, up to two times per day, for agitation but only after clonidine followed by Ativan® (lorazepam) were ineffective to control agitation/irritability.  CMS Ex. 14 at 4; CMS Ex. 20 at 2, 16, 23, 44, 50, 62, 72.  This represented a reduction in the frequency of administration of Seroquel® (quetiapine) to a maximum of two times per day and constituted tapering.

The medical record for Resident 45 shows that behavioral interventions were used at Children’s and Petitioner to control her agitation and irritability and reduce the need for PRN doses of psychotropics in addition to maintenance doses.

The April 3, 2018 Children’s discharge summary states that Resident 45’s agitation and dysautonomia consistently responded to being held and gently rocked.  However, it is important to note that the summary also states that she still became agitated one to two times per day with increased heartrate and her PRN medications were necessary to calm her with interventions such as holding, bathing, and rocking.  CMS Ex. 35 at 42, 91.  A pediatric sub-acute psychosocial evaluation dated April 4, 2018, shows that Resident 45 enjoyed being rocked to sleep.  CMS Ex. 18.

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There was also the April 3, 2018 email to Dr. Ward and Lindsay Barr cautioning them that constipation and overfeeding may contribute to Resident 45’s agitation and irritability.  CMS Ex. 35 at 29, 47.  This email shows that Children’s physicians and Petitioner’s staff were looking at all possible causes for and means to control Resident 45’s agitation/irritation, and not just attempting to keep her sedated as suggested by CMS.  CMS Br. at 12.

Petitioner had a care plan for Resident 45 dated April 3, 2018, that addressed the problem of the potential for agitation due to her medical condition.  Interventions were to monitor and assess every shift, administer medication ordered and observe for adverse reactions, provide a calm and noise free environment, always make the resident comfortable.  CMS Ex. 24 at 14.  An update to the care plan dated April 6, 2018, included interventions of holding and rocking, tactile stimulation, flash cards, musical toys, light-up toys, music, movies, one-way conversation, pet therapy, room visits, reading to her, and using different shapes with texture.  CMS Ex. 24 at 15.  A care plan dated April 3, 2018, addressed the problem of potential pain or discomfort and required assessing for pain, providing non-medication interventions for comfort, administering PRN medications for discomfort or pain, and evaluating the effectiveness of medication.  CMS Ex. 24 at 10.

Pediatric Initial Assessments completed on April 6, 2018 (following Resident 45’s readmission from Children’s) and June 7, 2018, show that Resident 45’s favorite activities were musical toys, light-up toys, and being held and rocked.  The assessments show that Resident 45 required daily interaction and age-appropriate activities to promote awareness and increase her development.  The plan of care listed interventions such as holding, rocking, flash cards, musical toys, light-up toys, music, movies, one-way conversation, tactile stimulation, pet therapy, room visits, reading, and slight massage of the head, shoulders, and arms for awareness of human companionship.  CMS Ex. 19.

On May 17, 2017, a physician order indicates Resident 45 may participate in activities as tolerated.  CMS Ex. 14 at 11.  On June 12, 2017, a physician ordered that Resident 45 may have bedside activities.  CMS Ex. 14 at 10.  The order permitting bedside activities was reissued on July 16, 2018.  CMS Ex. 14 at 8.  What activities constitute bedside activities are is not specified.  However, IDT meeting notes from June 12, 2018, show that Resident 45’s activities were at bedside only per physician order and she was provided holding and rocking for comfort, music, book reading, and tactile stimulation.  CMS Ex. 27.

Pediatrics Activity Participation Records for April through August 2018, show that holding and rocking were used for Resident 45, 5 times in April 2018, 7 times in May 2018, 6 times in June 2018, 11 times in July 2018, and 4 times in the first 8 days of August 2018.  CMS Ex. 25.

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Nursing notes show behavioral interventions were used frequently when Resident 45 was agitated and/or irritable, including repositioning (CMS Ex. 29 at 83, 90, 94, 148; P. Ex. K at 4-5), other unspecified comfort measures (CMS Ex. 29 at 90, 106; CMS Ex. 34 at 10; CMS Ex. 35 at 123; P. Ex. K at 4-5, 8); and cooling measures (P. Ex. K at 8).  Repositioning, unspecified comfort measures, bedside activities, warming blankets, and cooling measures were also employed by Petitioner’s staff prior to Resident 45’s April 3, 2018 readmission to Petitioner.  CMS Ex. 14 at 7-8, 10-11; CMS Ex. 29 at 5-74.

RN Rupp testified on behalf of Petitioner.  She explained that Petitioner is not a typical skilled nursing facility and has a California certificate to operate pediatric and adult subacute care units.  All Petitioner’s residents are subacute patients on life support.  Petitioner had 128 adult beds and 48 pediatric beds.  Petitioner’s staffing is one licensed nurse, a respiratory therapist, and a certified nursing assistant for every five residents.  Tr. 397-98.  Ms. Rupp testified that she is Petitioner’s vice president of operations and is also referred to as the chief nursing officer.  She testified she oversees all operations of the facility, particularly nursing, nursing staff, and respiratory staff.  She has bachelor’s and master’s degrees in nursing, she is a public health nurse, and she is a licensed nursing home administrator.  Tr. 403-05; P. Ex. B.

RN Rupp testified that she knows Resident 45.  She testified Resident 45 is monitored 24 hours a day, and there is usually someone in her room.  Tr. 406.  RN Rupp testified that Resident 45 has a history of ventilator dependence, a tracheostomy, severe dysautonomia, neuro-agitation, adrenal insufficiency, pulmonary hypoplasia, severe bronchial pulmonary dysplasia, she has a small brain with a severely narrow brainstem, she has no autonomic impulse control, severe autonomic instability, cystic encephalomalacia, thinning of the corpus colostrum, persistent agitation, and abnormal heart rates (both tachycardia and bradycardia), which required 24-hour monitoring.  Tr. 407.  She testified that she witnessed Resident 45 agitated between January and August 2018. She observed that Resident 45’s temperature rose, and they applied cooling measures, her heart rate rose into the 160s to the 190s, she would cry inconsolably no matter what staff tried, and they had to use medication to calm her.  Tr. 413-14.  She testified that when Resident 45 became agitated and inconsolable activities staff held and rocked Resident 45, talked to her, played with her, and tried to distract her.  They have a large activities department mostly dedicated to the pediatric subacute unit.  Dr. Ward and a nurse practitioner from Children’s are at Petitioner two to three times per week.  Petitioner’s staff reports to Dr. Ward or the nurse practitioner about Resident 45’s daily progress and they look at her MARs, her oxygen saturation recordings, and staff also calls Dr. Ward or the nurse practitioner when necessary.  Dr. Ward also participated in the two IDT meetings between January and August 2018.  Staff could also call Dr. Brook if there was a specific question related to neurology or palliative care for Resident 45.  Dr. Salinas was Resident 45’s attending physician during the period January through August 2018.  Tr. 414-17.

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RN Rupp testified that nonpharmacological (behavioral) interventions for Resident 45 involved using toys, music, reading, holding, carrying her in the room, playing cartoons or other appropriate video/music using a video display, and other possible interventions that she could not recall.  Tr. 417-19.  She testified that maintenance doses of Ativan® (lorazepam) and Seroquel® (quetiapine) had to be given as ordered to avoid any withdrawal and Petitioner had no discretion with the maintenance doses.  In 2018, when Resident 45 had a storm (agitation, irritability, high or low heart rate, elevated temperature, and inconsolable crying), they would try cooling measures, holding her, playing music, and those interventions might work for an hour or hour and a half, but then she would become extremely agitated, and it was necessary to use her PRN Ativan® (lorazepam) or other drug.  The addition of Seroquel® (quetiapine) by Children’s was very helpful in controlling Resident 45’s agitation.  Tr. 421-23.  She testified that Petitioner’s staff knows and trusts the Children’s team and they follow their orders strictly.  The doctors decide what to prescribe not Petitioner’s staff.  Tr. 423.  She testified that she would like staff to record every intervention attempted with a resident, but they do not and cannot write down everything that occurs.  She testified that every use of PRN Ativan was documented during April through August 2018, on the MAR.  Tr. 426-27.

On cross-examination, RN Rupp testified that Petitioner’s policy and procedure for administration of psychotropic medications reflects the standard of care.  Tr. 435-36.  She agreed that the specific condition for which a psychotropic medication is necessary should be reflected in the clinical record.  The reason for prescribing a psychotropic would be listed in the physician’s orders.  Tr. 437-38.  She testified that PRN orders are reevaluated every 14 days in Petitioner’s adult unit.  However, in the pediatric unit there is on-going evaluation by the physician who notes that there is no change needed.  The physician’s reevaluation would be documented in the physician notes and also in the charge nurse notes.  She testified that generally the nurse asks the physician whether he or she wants to continue the medication and the doctor decides.  She explained that Petitioner does not usually have children on psychotropic drugs.  It is the Children’s palliative care team that makes the recommendation for the medications and that is communicated to Dr. Ward or Dr. Brook who issue the orders for the medications and are informed if the medication is working so that the medication can be changed if necessary.  I note that the MARs for Resident 45 do not show that Dr. Brook issued orders for Resident 45.  RN Rupp simply misspoke when stating Dr. Brook issued medication orders.  Most orders in 2018 were issued by Dr. Salinas or Dr. Ward.  I do not find that these errors in RN Rupp’s recollection reflect adversely upon her credibility or the weight of her testimony.  PRN Ativan® (lorazepam) and Seroquel® (quetiapine) were prescribed for serious breakthrough agitation and they could tell if it did not work if she had continued breakthrough agitation and that would be reported to the physician.  She testified that if a psychotropic medicine was ordered for psychiatric reasons, then there would be a reevaluation every 14 days even on the children’s unit.  Tr. 438-43.

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RN Rupp’s testimony is fully credible and entitled to weight based on her training and experience and her direct knowledge of Resident 45.  Her testimony is unrebutted by any testimony or evidence presented by CMS.  Even though she freely admitted that staff may not enter in medical records every intervention attempted or used (Tr. 426-27), I find that her testimony and the entries in medical records in evidence indicating the use of behavioral interventions records shows it more likely than not that such interventions were used.

Surveyor Ekeomodi testified that she did find documentation of nonpharmacologic interventions documented in Resident 45’s medical record including reading and repositioning.  Tr. 305-06.  She testified that she saw Resident 45 sleeping throughout her survey, and she opined that could be due to the medication.  Tr. 267.  However, she testified earlier that during her initial observation of Resident 45, before her medication was administered, Resident 45 was awake and moving her head.  Tr. 251-52.  Another time, she heard the resident crying and then observed her laying in her bed crying but she stopped crying when she was touched to remove some drool coming from her mouth and was repositioned – I infer Resident 45 was not sleeping during this incident.  Tr. 255-56.  Surveyor Ekeomodi was only in the facility for three days from August 7 through 10, 2019.  Tr. 250-51.  She admitted that she saw Resident 45 awake at least twice so her testimony that Resident 45 was sleeping throughout her survey is an overstatement and not credible.  She subsequently clarified that there were times when she saw Resident 45 sleeping.  Tr. 269.

Surveyor Ekeomodi testified that she saw in the clinical record that the physician at Children’s reduced Resident 45’s dose of Seroquel® (quetiapine) to two times per day when she was readmitted to Petitioner but then toward the end of April or early May 2018, the Seroquel® (quetiapine) dose was increased to three times per day and the Ativan® (lorazepam) was increased from 0.2 mg to 0.3 mg every four hours.  Tr. 306-07.  Surveyor Ekeomodi testified that she did not see evidence in the clinical record that a gradual dose reduction was contraindicated.  She did see one pharmacy consultant document that indicated that gradual dose reduction was contraindicated.  However, she testified that she did not see in nursing notes "any failures or – or the results of decreasing the dose."  Tr. 307.  In response to my question, she clarified that she was just looking for any evidence that there was an attempted gradual dose reduction and a failure.  Tr. 307.  Surveyor Ekeomodi did not explain why Petitioner would encourage one of Resident 45’s physicians to attempt a gradual dose reduction when she admits that there was evidence that a gradual dose reduction was contraindicated (I infer she was referring to CMS Ex. 16).  She implies that a gradual dose reduction was necessary even though she found evidence that the determination was that it was contraindicated.  The unexplained inconsistency in her position means that her implied opinion that a gradual dose reduction was necessary is neither credible nor weighty.  She explained that if a physician explains in the clinical record why a gradual dose reduction is contraindicated, particularly if there is some discussion of risks versus benefits, that would be sufficient

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from her perspective.  She testified that surveyors do not second guess the physician.  Tr. 311-12.  The evaluation could be documented in IDT meeting notes, physician notes, progress notes, nursing documentation, or a care plan adjustment according to Surveyor Ekeomodi.  Tr. 314.  Surveyor Ekeomodi failed to acknowledge the evidence that the attempt to wean Seroquel® (quetiapine) in March 2018 resulted in Resident 45’s hospitalization for increased dystonia, the end of that wean, and the eventual increase in Seroquel® (quetiapine).  CMS Ex. 35 at 22-23, 29, 42, 47, 91, 94-95.  Surveyor Ekeomodi also apparently overlooked the evidence that on April 18, 2018, one of Petitioner’s RNs spoke with one of Resident 45’s physicians at Children’s.  Petitioner’s RN explained that Resident 45 initially did well following her April 3, 2018 discharge from Children’s.  However, Resident 45 subsequently had increased agitation and all her PRN medication was needed to address the agitation.  Petitioner’s RN requested an order for an additional dose of quetiapine (Seroquel®) PRN after all other PRN medications were exhausted.  The Children’s physician agreed to the additional PRN dose, but no more than two doses per day.  The physician noted that Resident 45 remained responsive to handling by her mother and noted a need to evaluate other reasons for agitation and possible interventions.  The note also indicated that the Children’s physician wrote to Dr. Ward and Petitioner’s nurse practitioner so that they could write an order in Petitioner’s system.  CMS Ex. 35 at 122.

In response to my questioning, Surveyor Ekeomodi explained that based on her review of Resident 45’s records there was a period of months when she had no reported episodes of agitation.  She did not find evidence that staff reported to Resident 45’s physicians that she was not having episodes of agitation.  She concluded that there should have been an attempt to wean Resident 45 off Ativan® (lorazepam) and Seroquel® (quetiapine).  She further concluded that if there was no plan to wean the resident there should have been documentation of an assessment by the physicians showing that weaning was contraindicated.  When she spoke to Dr. Ward, Dr. Ward indicated that Resident 45 would be seen by Children’s palliative care and the physician there may begin a weaning plan, but she would take guidance from palliative care.  Although she reviewed records from Children’s, Surveyor Ekeomodi did not testify that she interviewed physicians at Children’s palliative care who Dr. Ward indicated would make any future decisions about weaning Resident 45 off psychotropics.  Tr. 346-55, CMS Ex. 7 at 25-27.  Surveyor Ekeomodi agreed on cross-examination that Petitioner’s nursing staff did not have authority to attempt a gradual dose reduction.  She also testified that nurses are to follow physician orders as written.  Tr. 361.  Due to inconsistencies in her testimony and failure to recognize facts reflected by Resident 45’s medical record, I give little weight to the opinions of Surveyor Ekeomodi regarding the occurrence of any alleged regulatory violation.

The regulation requires that efforts be made to discontinue psychotropic drugs, unless clinically contraindicated, for residents who receive them, through gradual dose reduction (weaning) and behavioral interventions.  42 C.F.R. § 483.45(e)(2).

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CMS advises surveyors in the SOM that after a psychotropic medication is started or its dose is increased it **must be reevaluated at least quarterly to determine the potential for reducing or discontinuing the medication**.  CMS Ex. 6 at 16.  However, as already noted 42 C.F.R. § 483.45(e) imposes no substantive legal requirement regarding the frequency of reevaluation of the use of psychotropic medication, except in the case of antipsychotics under 42 C.F.R. § 483.45(e)(5).  CMS identifies as opportunities for the reevaluation of the use of psychotropics the pharmacist’s monthly medication review; the attending physician’s or prescribing practitioner’s review of resident progress; and quarterly MDS reviews.  CMS Ex. 6 at 18-19.

Regarding gradual dose reductions, CMS advises surveyors as a matter of policy in the SOM that the intent is to determine the appropriate dose and duration for each psychotropic (including antipsychotics) and minimizing the risk of adverse consequences.24  It is not clear whether by "adverse consequences" CMS refers to the potential adverse effects of using a psychotropic or the potential adverse effects of tapering the medicine though both should no doubt be considered.  Tapering a medication (gradual dose reduction or weaning) may serve one of two purposes according to CMS:  (1) finding the optimal dose, or (2) determining whether the medication benefits the resident.  Tapering may be indicated if:  (1) the resident’s clinical condition has improved or stabilized; (2) the underlying cause of the symptoms for which the psychotropic was prescribed have resolved; or (3) nonpharmacological interventions have been effective in reducing symptoms.  CMS Ex. 6 at 18.  CMS states that the time frames for and duration of attempts at gradual dose reduction must be consistent with accepted standards of practice.  CMS does not identify the standards of practice to which it refers or their source or specify the time frames for and duration of tapering psychotropics indicated by standards of practice.  Factors to be considered include the resident’s medication regimen, underlying causes of symptoms, risk factors, and the pharmacologic characteristics of the psychotropic medication.  **CMS specifically states that in some cases psychotropic medications may be required indefinitely.**  CMS Ex. 6 at 19.

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Although no substantive legal requirement regarding the frequency of gradual dose reduction (weaning or tapering) or the duration of such efforts is established by 42 C.F.R. § 483.45(e), CMS policy states that gradual dose reduction must be attempted in two separate quarters with at least one month between the attempts during the first year a psychotropic is prescribed or the resident is at the facility, unless contraindicated.  After the first year, CMS states that a gradual dose reduction must be attempted annually, unless clinically contraindicated.  CMS Ex. 6 at 19.  The policy is misleading in that it states the facility must attempt gradual dose reduction.  However, 42 C.F.R. § 483.45(e) is clear that the decisions of whether and when a gradual dose reduction should occur or whether it is contraindicated are decisions made by the attending physician or prescribing practitioner, many of whom are not employees of or bound by directions of a long-term care facility.

The evidence shows that there was an attempt to wean Resident 45 from Ativan® (lorazepam) in November 2017.  CMS Ex. 35 at 141, 180-81.  Petitioner’s Psychopharmaceutical Summary Sheet for Resident 45 for October, November, and December 2017, show that from November 21 to December 19, 2017, Resident 45 was being weaned from Ativan® (lorazepam).  CMS Ex. 26 at 5.  The evidence also shows that there was an attempt to wean Resident 45 from Seroquel® (quetiapine) in March 2018.  The order to wean was listed on the Petitioner’s physician order sheet for Resident 45.  CMS Ex. 14 at 9; CMS Ex. 20 at 18, 35; CMS Ex. 35 at 20, 134.  The evidence shows that after being weaned from Ativan® (lorazepam) and Seroquel® (quetiapine) each medicine was again increased by physician order.  CMS Ex. 14 at 4.  The April 3, 2018 order to use PRN clonidine before the PRN dose of Ativan® (lorazepam), and to use the PRN dose of Ativan® (lorazepam) before the PRN dose of Seroquel® (quetiapine) (CMS Ex. 14 at 4) is also a taper or wean if Ativan® (lorazepam) was to be used only if the clonidine was not effective and Seroquel® (quetiapine) was to be used only if the PRN dose of Ativan was not effective.  The April 3, 2018 order satisfied the definition of a gradual dose reduction under the CMS policy (CMS Ex. 6 at 4) as it was clearly intended to see if PRN clonidine could be effective without the need to administer a PRN dose of either Ativan® (lorazepam) or Seroquel® (quetiapine).  Another attempt to wean Resident 45 from Seroquel® (quetiapine) occurred when the April 11, 2018 order reduced the frequency that the PRN dose of Seroquel® (quetiapine) could be administered.  CMS Ex. 14 at 4; CMS Ex. 20 at 2, 16, 50, 62, 72.  According to CMS policy, gradual dose reduction must be attempted in two separate quarters with at least one month between the attempts during the first year a psychotropic is prescribed or the resident is at the facility, unless contraindicated.  After the first year, CMS states that a gradual dose reduction must be attempted annually, unless clinically contraindicated.  CMS Ex. 6 at 19.  Resident 45 was admitted to Petitioner May 30, 2017.  The evidence shows that Resident 45 began receiving Ativan® (lorazepam) either just before or just after her arrival at Petitioner.  CMS Ex. 35 at 159.  Therefore, under the CMS policy, tapering should have been attempted twice between June 2017 and June 2018, in two separate quarters with at least one month in between.  The evidence shows that Resident

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45 began receiving Seroquel in October 2017, while a resident of Petitioner.  Under the CMS policy, tapering of Seroquel® (quetiapine) should occur twice between October 2017 and October 2018, in two separate quarters with one month in between the attempts.  Therefore, as of the survey in August 2018, the time for attempting a second taper of Seroquel® (quetiapine) had not elapsed.  The evidence shows that there were two attempts to taper both Ativan® (lorazepam) and Seroquel® (quetiapine) within a year of Resident 45’s arrival at Petitioner, as required by the CMS implementation of the gradual dose reduction requirement of 42 C.F.R. § 483.45(e)(2).

Regarding gradual dose reduction of the maintenance doses of Ativan® (lorazepam) and Seroquel® (quetiapine), I am satisfied that the documentary evidence and testimony shows that tapering or weaning Resident 45 from the maintenance doses was contraindicated.  Dr. Brook testified that when a gradual dose reduction is attempted depends on what is going on with the patient.  She explained that the goal of a gradual dose reduction is to remove a medication that a patient no longer needs, safely, and without withdrawal symptoms.  She testified that Petitioner’s staff had no authority to attempt a gradual dose reduction without a physician’s order.  Tr. 199-207.  She opined that it would not have been possible with Resident 45 to stop Seroquel® (quetiapine) and Ativan® (lorazepam) and use only nonpharmaceutical interventions due to the level of the resident’s dysautonomia and neuro-agitation which were severe enough to be life-threatening and contrary to the goal of keeping her alive.  Tr. 208.  She opined that Resident 45 needed Seroquel® (quetiapine) and Ativan® (lorazepam).  She testified that behavioral interventions were appropriate as tolerated.  She opined that gradual dose reductions would not have been appropriate and were contraindicated because Resident 45 would not have tolerated it.  She opined that Resident 45 could not be tapered off psychotropics completely.  She opined that the PRN orders for Resident 45 for psychotropics were appropriate.  Tr. 218-21.  Dr. Brook’s opinions are credible and weighty based on her demonstrated knowledge of Resident 45 and her expertise.  Surveyor Ekeomodi did not have the knowledge of Resident 45 or the expertise as a pharmacist to rebut Dr. Brook’s testimony.

CMS attaches significance to its belief that Resident 45 showed no symptoms of agitation for three months.  CMS Br. at 12-13.  CMS cites CMS Ex. 26, Petitioner’s psychopharmaceutical summary sheets for Resident 45.  However, CMS errs as those documents show that Resident 45 had to be given a PRN dose of Seroquel® (quetiapine) for agitation/irritability in July 2018 (CMS Ex. 26 at 4), and she was given PRN doses of Ativan® (lorazepam) in April, June, and July 2018 for agitation/irritability (CMS Ex. 26 at 2).  Resident 45 had to be given PRN doses of Ativan® (lorazepam) and Seroquel® (quetiapine) during the period April through July 2018, despite having been on maintenance doses of each throughout that period.  CMS Ex. 26 at 1, 3.  CMS Ex. 26

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shows maintenance doses of Seroquel® (quetiapine) from October 2017 through February 2018.  CMS Ex. 26 at 6.  CMS Ex. 26 also shows that Resident 45 required 8 doses of PRN Ativan® (lorazepam) in January 201825 and 13 PRN doses of Ativan® (lorazepam) in February 2018 (CMS Ex. 26 at 7) following having been weaned from Ativan® (lorazepam) in November and December 2017 (CMS Ex. 26 at 5).  Dr. Brook testified that she did not recall whether Resident 45 had agitation storms between April and August 2018.  Tr. 188-94.  However, Dr. Brook testified in response to my questioning that the fact Resident 45 may have had few or no instance of neuro-agitation and dysautonomia storms documented would be the result of great medication management and excellent care by Petitioner’s staff.  Tr. 217-18.

CMS argues that Dr. Brook "did not explain why her own staff was successful in its attempts at gradual dose reduction weeks prior to Resident 45’s admission, while [Petitioner] could not have the same success."  CMS Br. at 13.  I infer CMS refers to the attempt to wean Resident 45 from Seroquel® (quetiapine) in March 2018.  However, it is clear from the evidence that the wean from Seroquel® (quetiapine) in March 2018 (CMS Ex. 20 at 28, 35) failed,26 resulting in increased dysautonomia, and an increase in Seroquel® (quetiapine).  CMS Ex. 35 at 22-23, 42, 91, 93-94.  Dr. Brook testified that in 2018, Resident 45 was seen in a clinic at Children’s every few months (actually every month from January through August 2018 by my count) but there were also telephone calls and email to which the Children’s team responded.  She clarified that she and the Children’s team continued to follow Resident 45 from her initial admission to Children’s when she was four months old.  Tr. 130.  She testified that over time there were several medication modifications but Resident 45 continued to have intermittent agitation due to her underlying brain issues/function.  Resident 45 required 24-hour care and that was why she lived at Petitioner.  Dr. Brook explained that Resident 45 was born premature at 27 weeks, she developed necrotizing fasciitis on her abdomen which ultimately went to her brain, resulting in a long-term abnormal brain that cannot regenerate.  Large areas of Resident 45’s brain were not functional resulting in abnormal activity.  She explained that

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Resident 45 reacts strongly to even small stimulus and her brain does not adequately control the relaxation and contraction of her muscles which means she will always require a ventilator for breathing.  For no perceptible reason Resident 45 would have completely abnormal vital signs and vital sign instability.  Dr. Brook cited as an example that Resident 45 would become very agitated and clamp down on or fight against the ventilator causing her heart rate to go down and she would desaturate (drop in blood oxygen level) fairly quickly making it difficult to bring her back.  The medical team tried several medications that act on different brain receptors to try to keep her from reacting in a way that put her life in danger.  Resident 45’s family goals were to keep her comfortable and alive and those became the goals of the medical team.  In 2018, the Children’s medical team had enough success that Resident 45 could be kept alive and be sent to Petitioner for subacute care.  Tr. 130-34.

Dr. Brook testified that it would not have been possible to handle Resident 45 with only nonpharmacological interventions like rocking and holding.  Tr. 146-47.  Although, on cross-examination she testified that Resident 45 could be comforted and soothed.  She testified that it was possible for Resident 45 to cry due to discomfort.  Sometimes Resident 45 liked rocking and holding.  During the period April through August 2018, she was thought to recognize her care giver, she could be calmed, sometimes responded positively to gentle massage, sat in her wheelchair and bouncer, she could be propped up with a pillow, sometimes she could be rocked to sleep, she could follow familiar sounds, she liked musical and light-up toys, and enjoyed music and she enjoyed lights on a screen that had sound.  Resident 45 had to take naps, she needed diaper changes, Dr. Brook felt that companionship was beneficial and sometimes she reacted favorably to human contact, she felt rocking and holding Resident 45 and tactile stimulation were beneficial when Resident 45 could tolerate it.  Dr. Brook agreed on cross-examination that reading to Resident 45 could stimulate her.  She clarified that Resident 45 could benefit from many of the things described if she was calm and awake but if she was sleeping or not calm, stimulus could cause a dysautonomic storm which would be harmful.  Tr. 188-94.  She testified to various drugs that were used to attempt to keep Resident 45 calm and awake from the time she first arrived at Children’s to August 2018.  Tr. 151-53.

CMS argues it is significant that Dr. Brook admitted at hearing that Resident 45 was weaned off Seroquel® (quetiapine) in August 2018, after the survey.  CMS Br. at 13.  Dr. Brook did testify as CMS represents that Resident 45 was weaned from Seroquel® (quetiapine) in August 2018.  However, CMS fails to consider Dr. Brook’s testimony that Resident 45 was weaned from Seroquel® (quetiapine) during a hospitalization in August 2018, when phenobarbital was started for seizures.  She testified that phenobarbital is much more sedating than Ativan® (lorazepam) and Seroquel® (quetiapine), causing Resident 45 to be calm but not awake.  Tr. 158-59, 164.  She testified it is always a goal to have a patient awake and alert and able to interact to maximize whatever potential a patient has.  Tr. 165.

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**Surveyor Allegation:  Resident 45 received two psychotropics, Seroquel® (quetiapine) and Ativan® (lorazepam), both of which had potential adverse side-effects or reactions.  CMS Ex. 1 at 72.  **

**CMS Allegation:  Petitioner failed to monitor Resident 45 for side-effects of Ativan® (lorazepam) and Seroquel® (quetiapine).  CMS. Br. at 9.**

The surveyor and CMS allegations that Petitioner failed to monitor Resident 45 for side effects from administration of Ativan® (lorazepam) and Seroquel® (quetiapine) are without merit.

CMS cites Resident 45’s need for suppositories to address constipation, her episodes of low blood pressure, and her seizures arguing that they are all know side effects of Seroquel® (quetiapine) and Ativan® (lorazepam).  CMS asserts that the surveyor did not find documentation in the residents MARs that Petitioner considered these as possible side effects of the psychotropics.  CMS Br. at 9.

Resident 45’s April 3, 2018 care plan for the use of psychotropic drugs required monitoring the resident’s response to medication; reporting any signs of sensitivity or response to the physician for possible medication change; and observing the resident for any adverse reactions.  CMS Ex. 24 at 9.  Resident 45’s care plan for agitation required that medication be administered for neuro-agitation and that every shift staff observe for any adverse reactions.  CMS Ex. 24 at 14.

On April 18, 2018, one of Petitioner’s RNs contacted a physician at Children’s and requested an additional PRN dose of Seroquel® (quetiapine) to address Resident 45’s break-through agitation.  CMS Ex. 35 at 122.  RN Rupp testified that Resident 45 is monitored 24 hours each day with staff often in her room.  Tr. 406.

Nursing notes and MARs also are evidence of monitoring for both adverse side-effects and effectiveness of medication administration.  CMS Ex. 20 at 34, 52, 64; CMS Ex. 25 at 4, CMS Ex. 29 at 11, 26, 71-72, 83, 94, 112, 147-48; P. Ex. K at 5, 8, 10.  Not every administration of the maintenance and PRN doses of Ativan® (lorazepam) and Seroquel® (quetiapine) have a corresponding note in records in evidence before me that state there were no side-effects and that the medication was effective.  However, 42 C.F.R. § 483.45(e) does not specifically impose a substantive legal requirement to either monitor or document side effects related to administering psychotropics, either positive or adverse.27  However, the detailed documentation that is in the record shows it

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is more likely than not that Petitioner’s staff was complying with Resident 45’s care plan and monitoring for adverse side effects and the effectiveness of the medications administered, even though they did not make a detailed record of every observation.

Surveyor Ekeomodi testified that she saw Seroquel® (quetiapine) administered to Resident 45 and when she checked back on Resident 45, she was sleeping.  She testified that Seroquel® (quetiapine) has a sedating effect.  On further examination she agreed that while Seroquel® (quetiapine) has a sedating effect, she did could not say that Resident 45 was sleeping more due to the use of Seroquel® (quetiapine).  She also could not opine that Resident 45 was sleeping more due to the use of Ativan® (lorazepam).  Tr. 261-66.  She testified that side effects of Seroquel® (quetiapine) include sedation, drowsiness, confusion, respiratory depression, hypotension (low blood pressure), seizures, irritation, and aggressive behaviors.  She found in the documents reviewed and interviews with staff that at times Resident 45 had low blood pressure, she slept quite a bit, and there was evidence of respiratory depression (low oxygen level), all of which are adverse reactions that may be caused by Seroquel® (quetiapine) and Ativan® (lorazepam).  She admitted she is not a nurse and testified nurses needed to assess Resident 45 to determine whether the medications were causing the adverse effects.  She also clarified that clonidine, which Resident 45 also received, may have contributed to the adverse effects that concerned her.  Tr. 266-68.  She testified that side effects of Ativan® (lorazepam) include drowsiness, sedation, it can be habit forming, and it may occasionally cause more agitation.  She could not recall whether the Petitioner’s documentation showed they were monitoring for some of the possible adverse reactions. Tr. 269-70.  She opined nurses should monitor for adverse effects of medication and if adverse effects seem to outweigh the benefit of the drug, the physician should be notified for revaluation of whether the medication is necessary or causing more harm than good.  Tr. 270-71.

Dr. Brook identified possible side effects of Seroquel® (quetiapine) as drowsiness, increased hunger, and diarrhea.  She testified that possible side effects of Ativan® (lorazepam) are drowsiness; at higher doses there may be changes in blood pressure; and there are possible serious side effects if used with some other medications.  Tr. 215-16

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She testified that Resident 1 was hospitalized in March 2018 due to tracheitis and possible sepsis not due to the use of Ativan® (lorazepam) or Seroquel® (quetiapine).  She testified that Ativan® (lorazepam) does not cause constipation and Seroquel® (quetiapine) can cause constipation or diarrhea.  She opined that Resident 45 may been constipated due to other medications or because her gut did not work normally, i.e., she did not have normal motility.  Tr. 159-61.  She testified that Children’s physicians did not identify any harm to Resident 45 due to the use of Ativan® (lorazepam) and Seroquel® (quetiapine).  Tr. 163.  She also opined that the use of those drugs did not hinder her development.  Tr. 166.

Both Dr. Brooks and Surveyor Ekeomodi are credible.  However, I find Dr. Brooks testimony weightier than Surveyor Ekeomodi regarding the impacts of Ativan® (lorazepam) and Seroquel® (quetiapine) upon Resident 45, i.e., whether the effects of the medications were adverse or beneficial.  Dr. Brooks was directly involved with the team that managed Resident 45’s care at Children’s and Petitioner.  Dr. Brooks had more knowledge of Resident 45’s case.  Dr. Brooks had more experience using psychotropics with pediatric patients.

**Summary**

I find that the surveyor allegation that suggests that no nonpharmacological interventions were used for Resident 45 (CMS Ex. 1 at 72) is without merit.

I also find of no merit CMS’ allegation that Petitioner failed to attempt behavioral interventions in an effort to discontinue Seroquel® (quetiapine) and Ativan® (lorazepam).  CMS Br. at 9.** **The documentary evidence shows that there were behavioral interventions used to address Resident 45’s agitation.  The weight of the evidence, including the documentary evidence and the testimony of Dr. Brook and RN Rupp, shows that Resident 45’s consulting and attending physicians determined that behavioral interventions alone were insufficient to control the resident’s agitation in all instances it needed to be controlled.  I find that the use of psychotropics in maintenance and PRN doses was appropriate to address the resident’s agitation when it could not be controlled by behavioral interventions and non-psychotropic medications.

The CMS argument that Petitioner failed to attempt gradual dose reductions of Ativan® (lorazepam) and Seroquel® (quetiapine) is also without merit.  The documentary evidence shows that Resident 45’s physicians did attempt to taper her off Ativan® (lorazepam) in November 2017 and April 2018, and Seroquel® (quetiapine) in March and April 2018.  The testimony of Dr. Brook shows that Resident 45 was weaned from Seroquel® (quetiapine) in August 2018, because she started receiving the more sedating

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phenobarbital.  I find that the documentary evidence and testimony of Dr. Brook amply support the determination reflected by the evidence that repeated efforts to wean Resident 45 from Ativan® (lorazepam) and Seroquel® (quetiapine) was contraindicated.28

The preponderance of the evidence shows that there was monitoring of Resident 45 for adverse side effects and the effectiveness of her medications.

**(4)  42 C.F.R. § 483.45(e)(4) requires**

PRN orders for psychotropic drugs are limited to 14 days.  Except as provided in § 483.45(e)(5), if the attending

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physician or prescribing practitioner believes that it is appropriate for the PRN order to be extended beyond 14 days, he or she should document their rationale in the resident’s medical record and indicate the duration for the PRN order.

**(5)  42 C.F.R. § 483.45(e)(5) requires**

PRN orders for anti-psychotic drugs are limited to 14 days and cannot be renewed unless the attending physician or prescribing practitioner evaluates the resident for the appropriateness of that medication.

**CMS Allegation:  In violation of 42 C.F.R. § 483.45(e)(3)-(5), psychotropic drugs were administered pursuant to an indefinite PRN order without documentation in the medical record justifying extending the order beyond 14 days or any meaningful evaluations.  CMS Br. at 13-15.**

**CMS Allegation:  Petitioner failed to provide documentation that shows PRN orders for psychotropic medications were reevaluated every 14 days.  CMS Br. at 14; CMS Reply at 3.**

The requirements of 42 C.F.R. § 483.45(e)(4) are clear.  Prescriptions for psychotropics to be administered PRN are limited to 14 days.  However, except for antipsychotics, the attending physician or prescribing practitioner may extend a PRN order for more than 14 days.  If the PRN order is extended beyond 14 days, the rationale for the extension and duration should be specified in the resident’s medical record.

There is no dispute that Resident 45 was prescribed Ativan® (lorazepam), a psychotropic, and Seroquel® (quetiapine), a psychotropic that is classified as an antipsychotic.  Resident 45 was prescribed both at various times and doses from the fall of 2017 to after the survey on August 10, 2018.  Both drugs were prescribed in a maintenance dose and a PRN dose and for more than 14 days.  CMS Ex. 20 at 2-3, 8, 10, 16, 18, 19, 38, 42, 49-50, 55, 57, 61, 65, 67, 71-72.  Subsections 3,29 4, and 5 of 42 C.F.R. § 483.45, apply only to psychotropics ordered on a PRN basis and the orders for maintenance doses of Ativan® (lorazepam) and Seroquel® (quetiapine) are not at issue under these regulatory provisions.  CMS focuses on the prescriptions for PRN doses

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of Ativan® (lorazepam) and Seroquel® (quetiapine) during the period April 3, 2018, through the survey on August 10, 2018.

The record includes two forms used by Petitioner’s consultant pharmacist to notify Resident 45’s physician, Dr. Salinas, that PRN orders for Seroquel® (quetiapine) and Ativan® (lorazepam) had to be reevaluated every 14 days.  The forms are undated.30  CMS Ex. 16 at 2-3.  A separate copy of the form for Seroquel® (quetiapine) includes hand‐written entries.  There is no dispute that the hand‐written entries were made by one of Resident 45’s physicians, most likely Dr. Salinas as she issued the orders in effect at the time of the pharmacist review.  The hand-written entries are dated May 8, 2018.  CMS Ex. 16 at 1.  There is no form for Ativan® (lorazepam) with hand-written entries.  CMS Ex. 16.  The hand-written entries on the form for Seroquel® (quetiapine) state that the medicine is given for severe episodes of neuro-agitation with muscle spasms and pain.  The entries indicate that if clonidine and Ativan® (lorazepam) are not effective then Seroquel® (quetiapine) is the next option.  The entries indicate that the need for the PRN dose of Seroquel® (quetiapine) would continue to be discussed and evaluated with Children’s palliative care.  CMS Ex. 16 at 1.  The entries clearly indicate that the physician evaluated Resident 45’s need for Seroquel® (quetiapine).  The entries also clearly indicate that the physician intended that the order continue for an indefinite period.

Under 42 C.F.R. § 483.45(e)(2), a PRN order for an antipsychotic is limited to 14 days.  The regulation is specific that the order "cannot be renewed unless the attending physician or prescribing practitioner evaluates the resident for the appropriateness of that medication."  The regulation does not provide that a PRN order for an antipsychotic automatically expires after 14 days.  The regulation does not specify that a physician must issue a new order.  Rather, the regulation states that the PRN order cannot be renewed.  The regulation is unclear about the status of a PRN order that is not renewed.  However, I note that if the regulation was construed to automatically invalidate a PRN order for an antipsychotic because it automatically expired or was not renewed and could not be followed without violating the regulation, the regulation would be applied in a

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manner to override or supersede the resident’s attending physician or prescribing practitioner’s order.  For example, if the regulation was construed to mean that a PRN order for an antipsychotic was no longer valid after 14 days, a long-term care facility would violate the regulation if it continued to administer the antipsychotic.  I find it highly unlikely that Congress intended to permit the Secretary to supplant the Secretary’s judgment or that of CMS for the judgment of the attending physician or prescribing practitioner.  Indeed, such an approach would mean that medical judgment was being exercised by the federal government and most likely with little or no qualified knowledge of the resident’s actual need for care and services.  Such an approach would also mean that a long-term care facility could be penalized for violation of the regulation unless the facility refused to follow the order for the antipsychotic – arguably not in the best interest of a resident, at least in some cases.  The more reasonable construction of the regulation is that a facility is responsible to remind an attending physician that a PRN order for an antipsychotic must be renewed every 14 days.  If the facility does so and has documented or can offer other credible evidence of its efforts to help the attending physician or prescribing practitioner to comply with the regulation, it should be a defense for the facility to a charge of violation of the regulation.  The fact that a facility continues to administer a PRN dose of an antipsychotic after 14 days even when the attending physician or prescribing practitioner has failed to renew the PRN order should not be the basis for finding a violation of 42 C.F.R. § 483.45(e)(5).  The regulation also requires that before a PRN order for a psychotropic is renewed, the attending physician or prescribing practitioner must evaluate the resident for the appropriateness of the medication.  42 C.F.R. § 483.45(e)(5).  The regulation does not specify that the attending physician or prescribing practitioner must conduct a physical assessment of the resident.  Rather, the regulation requires an evaluation without specifying how the evaluation must be done.  The regulation arguably leaves the decision as to the degree or thoroughness of the evaluation to the medical judgment of the attending physician or prescribing practitioner, who may find that a medical record review, physical assessment, or some other form of evaluation is what is required.

What is not clear from the regulation, CMS has attempted to require by policy.  CMS policy regarding prescribing PRN antipsychotic medication imposes a 14-day time-limit with no provision for extension of an order for an antipsychotic.  After 14 days the attending physician or prescribing practitioner may write a new order but must first directly examine the resident and assess the resident’s current condition and progress to determine if the new order is appropriate.31  The physician or practitioner should record

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in the resident’s medical record whether the antipsychotic continues to be needed on a PRN basis, the benefit of the PRN medication to the resident, and whether the resident’s expressions or indications of distress improved due to the PRN antipsychotic.  CMS Ex. 6 at 20-21.  Therefore, CMS policy is much more aggressive than the regulation.  The CMS policy implies that after 14 days a PRN order for an antipsychotic is invalid and a new order must be issued and only after a direct examination of the resident by the attending physician or prescribing practitioner.  The CMS policy may be read to make a facility liable for the attending physician’s or prescribing practitioner’s failure to conduct a direct examination and issue a new PRN order for an antipsychotic that will be invalid after 14 days.  Worse, the CMS policy may be read to impose liability on a long-term care facility for violating 42 C.F.R. § 483.45(e)(5) if the facility continues to administer a prescribed PRN antipsychotic after 14 days have elapsed and no new order is written following a direct physical examination.  If that interpretation is followed, the Secretary and CMS would clearly be supplanting their judgment for the medical judgment of the resident’s physician.  CMS has been clear that is not the intent of the regulations specifically stating that "[t]he regulations and guidance concerning psychotropic medications are not intended to to (sic) supplant the judgment of a physician or prescribing practitioner in consultation with facility staff, the resident and his/her representatives and in accordance with appropriate standards of practice."  CMS Ex. 6 at 15 (emphasis added).

What is a reasonable interpretation of what 42 C.F.R. § 483.45(e)(5) requires of Petitioner?  It is clearly not the Secretary’s or CMS’ intention to control treatment decisions through the regulations.  Not only has CMS said as much, but it is commonsense that the Secretary and CMS cannot make treatment decisions because it is not possible for them to properly assess the need for care and services of thousands of individual residents.  Therefore, 42 C.F.R. § 483.45(e)(5) should not be read to require that a facility must stop administering a PRN antipsychotic after 14 days if the resident is not evaluated and the order is not renewed or reissued.  However, CMS clearly intends to use facilities to ensure compliance with the regulations.  To accomplish the CMS goal of having facilities maintain regulatory compliance, it is reasonable to read 42 C.F.R. § 483.45(e)(5) to impose on facilities the requirement to show that facility staff made efforts to ensure that PRN orders for antipsychotics were renewed every 14 days following evaluation of the resident.  That interpretation is consistent with the plain language of the regulation.

Dr. Salinas issued the April 11, 2018 order for the PRN dose of the antipsychotic Seroquel® (quetiapine) for agitation/irritability, up to two times per day after PRN clonidine and PRN Ativan® (lorazepam) were not effective.  CMS Ex. 14 at 4.  In this case, the evidence does not include documents showing that every 14 days from April 11 through August 10, 2018, Petitioner notified Dr. Salinas that she needed to document for Petitioner’s records that she evaluated Resident 45 and decided to renew the PRN order.  The record includes only the consultant pharmacist’s note with the hand-written entry dated May 8, 2018.  CMS Ex. 16 at 1.  Accordingly, the evidence shows that a violation

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of 42 C.F.R. § 483.45(e)(5) occurred.  The issue addressed in the next section of this decision is whether that violation amounted to noncompliance.

Ativan® (lorazepam) is not an antipsychotic subject to 42 C.F.R. § 483.45(e)(5).  However, Ativan® (lorazepam) is subject to 42 C.F.R. § 483.45(e)(4).  The foregoing analysis of what substantive legal requirements 42 C.F.R. § 483.45(e)(4) imposes upon Petitioner is the same as for 42 C.F.R. § 483.45(e)(5).  It is not reasonable to read the regulation to require Petitioner to stop administering a PRN dose of the psychotropic Ativan after 14 days if the attending physician or prescribing practitioner fails to order that the prescription be extended and has documented the duration of the extension and the rationale in the resident’s medical records.  A sensible reading of the substantive legal requirement of 42 C.F.R. § 483.45(e)(4) is that a facility must make efforts to ensure that an attending physician or prescribing practitioner reviews an order for a PRN psychotropic after 14 days and, if the physician or practitioner determines it is appropriate to extend the order beyond 14 days, the physician or practitioner documents their rationale and how long the PRN order will be in effect.  The regulation does not state that a PRN order for a psychotropic such as Ativan® (lorazepam) cannot be extended indefinitely and does not require review every 14 days if the extension exceeds 14 days.  If the attending physician or prescribing practitioner fails to comply, the regulation should not be read to require Petitioner to stop administering the PRN dose of the psychotropic or face a sanction by CMS.  Neither 42 C.F.R. § 483.45(e)(4) nor (5) states or implies that an order for a psychotropic is invalid and may not be followed once the 14-day period has elapsed.  Such a regulatory provision or the interpretation of the current regulatory language would place the Secretary and CMS in the position of making treatment decisions for individual residents.  Given the fact the Board imposed the burden of persuasion on Petitioner, in order to establish compliance Petitioner needs to present some documentary or other credible evidence that it informed the attending physician of prescribing practitioner of the need to reevaluate a PRN order for a psychotropic and to document how long the order will be extended if it is to be and the rationale for doing so.

On April 3, 2018, Dr. Salinas issued the order for PRN Ativan® (lorazepam) every six hours PRN for agitation or irritability, but after clonidine was administered to address agitation/irritability and (I infer) was not effective.  CMS Ex. 14 at 4.  In this case, there is no documentary evidence of Petitioner’s efforts to get Dr. Salinas to reevaluate the need for Ativan® (lorazepam) 14 days after the prescription was issued.  The evidence also does not show that Petitioner informed her of the need to determine whether to extend the order and for how long, and to get her to document in Resident 45’s medical record.  The consultant pharmacist note (CMS Ex. 16 at 2) is undated and I have insufficient evidence to draw any inference about its date or that it was ever sent to Dr. Salinas or Dr. Ward.  Accordingly, the evidence shows that a violation of 42 C.F.R. § 483.45(e)(4) occurred.  The issue addressed in the next section of this decision whether that violation amounted to noncompliance.

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It is important to note neither 42 C.F.R. § 438.45(e)(4) nor (5) require that Petitioner or the resident’s IDT make any treatment decision for the resident.  Rather, the purpose of 42 C.F.R. § 483.45(e)(4) and (5) is to give Petitioner responsibility to remind attending physicians and prescribing practitioners to review and document decisions related to the PRN orders for psychotropics.  Therefore, if Petitioner fails to fulfill its substantive duty under the regulation, its failure is a failure to ensure that the record is documented to reflect its efforts.  The benefit to nursing home residents of a long-term care facility working to ensure that physicians and practitioners do review PRN orders for psychotropics, is that such review may reduce the instances of unnecessary or improper use of the drugs, for example to keep the resident sedated rather than active and awake so that the resident can "attain or maintain the highest practicable physical, mental, and psychosocial well-being."  42 C.F.R. § 483.24 ("[q]uality of life is fundamental principle that applies to all care and services provide to facility resident.").  Ultimately, the responsibility for the prescribing decision is the attending physician’s or prescribing practitioner’s, not the responsibility of the facility, the Secretary, or CMS.  Indeed, Surveyor Ekeomodi made clear during testimony at hearing that the determination of whether any adverse effects of medication, including psychotropics, is outweighed by the benefit to a resident is to be determined by the resident’s physician.  The role of Petitioner’s staff is to observe and report to the physician.  Tr. 270-71.

In the day of electronic medical records, it would seem a minor matter for a long-term care facility to create a form32 that could be sent to an attending physician or prescribing practitioner every two weeks reminding them of the need for reevaluation of a PRN order for psychotropics with check boxes to show that the physician or practitioner did the review or evaluation of the resident, and decided to extend the order for a specified or an indefinite period or renew the PRN order for an antipsychotic.  Even if the physician or practitioner failed to comply, the facility could prove to CMS and state surveyors that it had done what is required of the facility by 42 C.F.R. § 483.45(e)(4) and (5).  Of course, a physician’s focus is generally not likely to be ensuring that a facility meets its requirements for documentation, and it is possible physicians will not be responsive to requests by a facility for documentation.  However, evidence of an attempt to comply by Petitioner should be all that is necessary to satisfy surveyors and CMS that no violation of 42 C.F.R. § 483.45(e)(4) and (5) occurred.

RN Rupp testified that PRN orders are reevaluated every 14 days in Petitioner’s adult unit.  However, in the pediatric unit there is on-going evaluation by the physician who

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notes that there is no change needed.  The physician’s reevaluation would be documented in the physician notes and in the charge nurse notes.  She testified that generally the nurse asks the physician whether he or she wants to continue the medication and the doctor decides.  She explained that Petitioner does not usually have children on psychotropic drugs.  It is the Children’s palliative care team that makes the recommendation for the medications and that is communicated to Dr. Ward or Dr. Salinas who issue the orders for the medications and are informed if the medication is working so that the medication can be changed if necessary.  PRN Ativan® (lorazepam) and Seroquel® (quetiapine) were prescribed for serious breakthrough agitation and they could tell if it did not work if Resident 45 had continued breakthrough agitation and that would be reported to the physician.  RN Rupp testified that if a psychotropic medicine was ordered for psychiatric reasons, then there would be a reevaluation every 14 days even on the children’s unit.  Tr. 438-43.

RN Rupp’s testimony is credible.  However, she did not testify that she knew that in Resident 45’s case Dr. Salinas reevaluated the use of PRN psychotropics after 14 days or that Dr. Salinas documented her rationale for extending the PRN order for Ativan® (lorazepam) or renewing the order for Seroquel® (quetiapine) in Resident 45’s medical record.  I have received no document that shows Petitioner’s staff reminded Dr. Salinas every 14 days of the need to reevaluate the use of Seroquel® (quetiapine) and renew the prescription if she wanted to.  I have received no document that shows that Petitioner advised Dr. Salinas of the requirements of 42 C.F.R. § 483.45(e)(4) to specify the period a PRN psychotropic is to be administered and the rationale for the extension.  I can infer from the fact Petitioner did not present the documentation, that it does not exist, and more likely than not the documentation was not done.  The evidence is insufficient for me to infer Petitioner reminded Dr. Salinas of the requirements of 42 C.F.R. § 483.45(e)(4) and (5).33

I do not infer that Dr. Salinas, the care team at Children’s, and the IDT were not regularly evaluating Resident 45’s need for PRN Ativan® (lorazepam) and Seroquel® (quetiapine) and how to minimize the use of psychotropics.  Indeed, the evidence summarized above shows that Resident 45 and her need for care and services were closely monitored and

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supervised by her attending physician, the team of physicians at Children’s, and Petitioner’s staff.

**(6)  Risk for More than Minimal Harm Required for Noncompliance as Opposed to Determining Reasonableness of Enforcement Remedy**

**Surveyor Allegation:  Resident 45 suffered actual harm.  CMS Ex. 1 at 71. **

**CMS Allegation:  Resident 45 suffered actual harm.  CMS Br. at 9, 16. **

I have concluded that Petitioner violated 42 C.F.R. § 483.45(e)(4) and (5).  However, violation of the regulation alone does not amount to noncompliance that triggers CMS’ authority to impose an enforcement remedy.

CMS and the states have delegated authority to impose enforcement remedies against a SNF or NF, if the SNF or NF is not in "substantial compliance" with federal participation requirements.  42 C.F.R. §§ 488.400, 488.402(b).  "Substantial compliance" means that a facility is maintaining a level of compliance with statutory and regulatory participation requirements so that, even if there is a violation of the requirements (a deficiency), the violation (deficiency) does not pose a risk for causing more than minimal harm to residents.  42 C.F.R. § 488.301.  "Noncompliance" exists when violation of a statutory or regulatory participation requirement, i.e., a deficiency, poses a risk for more than minimal harm.  42 C.F.R. § 488.301.  Therefore, even if a facility violates a statutory or regulatory requirement, CMS may not impose enforcement remedies if the deficiency does not pose a risk for more than minimal harm.

In a long-term care enforcement case such as this, the Board has determined that the standard of proof, or quantum of evidence required, is a preponderance of the evidence.  CMS has the burden of coming forward with the evidence and making a prima facie showing of a basis for imposing an enforcement remedy.  The Board has stated that CMS must come forward with "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; *Batavia Nursing & Convalescent Ctr.*, DAB No 1904.  "Prima facie" means generally that the evidence is "[s]ufficient to establish a fact or raise a presumption unless disproved or rebutted." Black's Law Dictionary 1228.  In *Hillman Rehab. Ctr.*, the Board described the elements of the CMS prima facie case in general terms as follows:

**HCFA [now known as CMS] 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

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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.

DAB No. 1611 at 8 (emphasis added).  Thus, CMS has the initial burden of coming forward with sufficient evidence to show that its decision to impose an enforcement remedy is legally sufficient under the statute and regulations.  To make a prima facie case that its decision was legally sufficient, CMS must:  (1) identify the statute, regulation or other legal criteria to which it seeks to hold the provider; (2) come forward with evidence upon which it relies for its factual conclusions that are disputed by Petitioner; and (3) show how the deficiencies it found amount to noncompliance that warrants an enforcement remedy, that is, that there was a risk for more than minimal harm due to the regulatory violation.  *See e.g., Evergreene Nursing Care Center*, DAB No. 2069 at 21 (Petitioner showed no potential for more than minimal harm by showing overall effort to maintain and improve resident’s nutrition adequately ensured resident did not suffer more than minimal harm).  In *Evergreene Nursing Care Ctr.*, the Board explained its "well-established framework for allocating the burden of proof on the issue of whether a SNF is out of substantial compliance" as follows:

CMS has the burden of coming forward with 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.  If CMS makes this prima facie showing, then the SNF must carry its ultimate burden of persuasion by showing, by a preponderance of the evidence, on the record as a whole, that it was in substantial compliance during the relevant period.

DAB No. 2069 at 7.  CMS makes a prima facie showing of noncompliance if the credible evidence CMS relies on is sufficient to support a decision in its favor absent an effective rebuttal.  The regulation gives Petitioner notice of the criteria or elements it must meet to comply with the program participation requirement established by the regulation.  5 U.S.C. §§ 551(4), 552(a)(1).  Therefore, in order to make a prima facie showing of noncompliance, CMS must show that Petitioner violated the regulation by not complying with one or more of the criteria or elements of the regulation, which is a deficiency.  CMS must also show that the deficiency amounted to "noncompliance," that is, that Petitioner was not in substantial compliance because the deficiency posed a risk for more than minimal harm.  *See Jennifer Matthew Nursing & Rehab. Ctr.*, DAB No. 2192 at 20 n.12 (2008).  A facility can overcome CMS’s prima facie case either by rebutting the evidence upon which that case rests, or by proving facts that affirmatively show

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substantial compliance.  "An effective rebuttal of CMS’s prima facie case would mean that at the close of the evidence the provider had shown that the facts on which its case depended (that is, for which it had the burden of proof) were supported by a preponderance of the evidence."  *Id*. at 7-8 (citations omitted).

Based on the example of Resident 45 CMS made a prima facie showing of a violation of 42 C.F.R. § 483.45(e)(4) and (5).  The surveyors and CMS allege that the violation posed a risk for more than minimal harm for Resident 45 because they allege that Resident 45 suffered actual harm.  The surveyors’ determination that there was a risk for more than minimal harm due to the regulatory violation is reflected by the citation of deficiency in the SOD.  CMS Ex. 1 at 70.  Surveyor Ekeomodi did not identify specifically in her testimony the risk for more than minimal harm the violation of 42 C.F.R. § 483.45(e)(4) and (5) posed for Resident 45.  She testified generally that the risks for harm to a patient receiving too much psychotropic medication are increased side effects such as sedation, hypotension, and constipation.  Tr. 271-72.  She did not testify that she found that Resident 45 received too much psychotropic medication or that Resident 45 suffered the side effects she identified.  As previously noted, CMS states as policy in the SOM that "the failure of the facility to provide appropriate care and services to manage the resident’s medication regime to avoid unnecessary mediations and minimize negative outcomes places residents at risk for more than minimal harm."  CMS Ex. 6 at 28.  The CMS policy establishes a rebuttable presumption34 that a violation of 42 C.F.R. § 483.45(e) posed a risk for more than minimal harm.  42 C.F.R. § 488.26(c)(2).  The CMS policy, by its terms, indicates that the presumption that a violation of 42 C.F.R. § 483.45(e) poses a risk for more than minimal harm may be rebutted by showing that actual care and services received by a resident, including efforts to control the resident’s medication regime, were sufficient to avoid unnecessary medication and minimize negative outcomes for the resident.  CMS Ex. 6 at 28.

In the example of Resident 45, CMS satisfied the requirement to make a prima facies showing of a risk for more than minimal harm due to the regulatory violation based on the determination of the surveyors reflected by the SOD (CMS Ex. 1 at 71) and the presumption established by the SOM (CMS Ex. 6 at 28).  Therefore, the burden of persuasion is upon Petitioner to show by a preponderance of the evidence that there was no risk for more than minimal harm to Resident 45 on the facts of this case to rebut the CMS prima facie showing that there was a risk for more than minimal harm.  Petitioner meets the burden by showing that actual care and services, including its efforts to control

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Resident 45’s medication regime, were sufficient to avoid unnecessary medication and minimize negative outcomes.  CMS Ex. 6 at 28.

The burden of persuasion on the risk for harm element of the CMS prima facie case is subject to being confused with the standard for review of the level of noncompliance involved in reviewing the reasonableness of a CMP.  Under 42 C.F.R. § 498.60(c)(2) "CMS’ determination as to the level of noncompliance of a SNF, NF, HHA [home health agency], or hospice program must be upheld unless it is clearly erroneous."  Under 42 C.F.R. § 498.3(d)(10) a CMS determination of level of noncompliance of a SNF, NF, HHA, or hospice program is not an initial determination subject to ALJ review except as specified by 42 C.F.R. § 498.3(b)(13).  Under 42 C.F.R. § 498.3(b)(13) a finding of noncompliance that leads to an enforcement remedy is reviewable but not the CMS determination of which sanction to impose in cases involving a SNF, NF, or HHA.  Under 42 C.F.R. § 498.3(b)(14) the level of noncompliance found by CMS in the case of a SNF, NF, or HHA is subject to review but only if a successful challenge on the issue would affect the range of the civil money penalty that CMS could collect or a finding of substandard quality of care that causes the loss of eligibility of a SNF or NF to conduct a nurse aide training program.  Therefore, when "level of noncompliance" is used, the regulations are referring to review of the enforcement remedy imposed by CMS and not review of whether the regulatory violation posed a risk for more than minimal harm and amounted to noncompliance which triggers CMS authority to impose any enforcement remedy.  Consistent with my interpretation, is the fact that subsection 498.60(c) of Title 42 which imposes the clearly erroneous standard is titled "Scope of review:  Civil money penalty."  I conclude that the clearly erroneous standard does not apply to the determination of whether there is a basis for the imposition of an enforcement remedy.  The Board has been clear that Petitioner has the burden of showing it was in substantial compliance by a preponderance of the evidence.  *Evergreene Nursing Care Ctr.*, DAB No. 2069 at 7 (if CMS makes a prima facie case, facility bears burden to show by preponderant evidence it was in substantial compliance or had an affirmative defense).  Therefore, Petitioner must rebut the CMS prima facie case on the element of the risk for harm by a preponderance of the evidence rather than by showing the CMS conclusion was clearly erroneous.35

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Under the CMS policy in the SOM the presumption that a violation of 42 C.F.R. § 483.45(e) poses a risk for more than minimal harm may be rebutted by showing that actual care and services received by a resident, including efforts to control the resident’s medication regime, were sufficient to avoid unnecessary medication and minimize negative outcomes for the resident.  CMS Ex. 6 at 28.  I do not review again in this section the evidence already discussed.

The evidence shows that Resident 45 was closely followed by physicians at Children’s with many evaluations of Resident 45’s medication regime, including the use of PRN psychotropics.  The evidence shows evaluation of medications prior to recommendations to the attending physicians, Dr. Salinas and previously Dr. Ward, to taper the psychotropics by adjusting dosages or stopping the drugs completely, and then increasing the use of the PRN psychotropics when after evaluation increases were determined to be necessary to control Resident 45’s neuro-agitation and/or irritability.  The necessity for the PRN psychotropics was a decision best left to the sound discretion of Resident 45’s physicians and not for second guessing by CMS and the state agency.  The evidence shows that gradual dose reductions were attempted and failed prior to the survey.  The evidence shows that the elimination of Seroquel® (quetiapine) following the survey resulted in the use of the more sedating phenobarbital, which according to Dr. Brook was inconsistent with the goal of keeping Resident 45 as awake as possible so that she could

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develop to the maximum of her potential.  The evidence shows that nonpharmacologic interventions were authorized by Resident 45’s physicians and used by Petitioner’s staff rather than psychotropics, albeit in many instances they were not sufficient, and medication was needed to calm the resident.  Although CMS argues that Resident 45 was subject to side effects due to the use of the psychotropics, Dr. Brook explained that the possible side effects listed by CMS were more likely than not caused by Resident 45’s medical condition.  Dr. Brook’s knowledge and expertise as a physician in the specialty of palliative care with pediatric patients is significant.  Dr. Brooks had direct personal knowledge of Resident 45.  Dr. Brooks’ opinions significantly outweigh those of Surveyor Ekeomodi, a pharmacist, not a physician or nurse, with minimal or no pediatric experience, and no direct personal knowledge of Resident 45’s case except her minimal observation of Resident 45 during her three days at Petitioner during the survey.

Based on my de novo review of all the evidence of record, I find that the actual care and services received by a Resident 45, including efforts to control her medication regime, were sufficient to avoid unnecessary medication and minimize negative outcomes for her. Petitioner’s failure that led to the conclusion that Petitioner violated 42 C.F.R. § 483.45(e)(4) and (5), was the failure to document that it notified Resident 45’s attending and prescribing physicians of the requirements of 42 C.F.R. § 483.45(e)(4) and (5).  Petitioner could not compel Resident 45’s physicians to comply or simply refuse to administer medications ordered by the physicians.  Petitioner’s failure to document that on more than the one occasion in May 2018, that Resident 45’s attending and prescribing physician was notified of the requirements of 42 C.F.R. § 483.45(e)(4) and (5) did not pose a risk for Resident 45 to receive unnecessary drugs or have negative outcomes related to drugs administered on a PRN basis because the evidence shows Resident 45 was closely monitored by Children’s physicians and Petitioner’s staff and she received the necessary care and services.  The CMS policy indicates that the presumption that a violation of 42 C.F.R. § 483.45(e) poses a risk for more than minimal harm may be rebutted by showing that actual care and services received by a resident, including efforts to control the resident’s medication regime, were sufficient to avoid unnecessary medication and minimize negative outcomes for the resident.  CMS Ex. 6 at 28.

Accordingly, I conclude that Petitioner violated 42 C.F.R. § 483.45(e)(4) and (5), but the violation did not pose a risk for more than minimal harm, there is no noncompliance, and no enforcement remedy is authorized under 42 C.F.R. § 488.477.

**(f) Resident 115 -- Findings and Analysis Related to 42 C.F.R. 483.45(e)**

**Surveyor Allegation:  The surveyors did not find documentation that Resident 115 was monitored for adverse reactions associated with nortriptyline (Pamelor®) use, including tachycardia and postural**

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**hypotension.**36**  CMS Ex. 1 at 72; Tr. 100-01; CMS Br. at 2, 16-18; CMS Reply at 7-8.**

**CMS Allegation:  The evidence does not show that Resident 115 was monitored for additional possible side effects of psychotropic medications not alleged in the SOD, including drowsiness, dry mouth, blurred vision, or constipation, or an assessment as to whether symptoms were related to psychotropic medications. ****CMS Br. at 17; CMS Reply at 2, 7-8. **

The surveyors and CMS allege that Petitioner violated 42 C.F.R. § 483.45(e) because Petitioner did not have documents showing that Resident 115 was monitored for the side effects of nortriptyline.  Before proceeding with findings of fact and analysis it is necessary to review the regulatory requirements.  The regulation CMS and the surveyors allege Petitioner violated provides:

(e) Psychotropic drugs. Based on a comprehensive assessment of a resident, the facility must ensure that—

(1) Residents who have not used psychotropic drugs are not given these drugs unless the medication is necessary to treat a specific condition as diagnosed and documented in the clinical record;

(2) Residents who use psychotropic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs;

(3) Residents do not receive psychotropic drugs pursuant to a PRN order unless that medication is necessary to treat a diagnosed specific condition that is documented in the clinical record; and

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(4) PRN orders for psychotropic drugs are limited to 14 days. Except as provided in § 483.45(e)(5), if the attending physician or prescribing practitioner believes that it is appropriate for the PRN order to be extended beyond 14 days, he or she should document their rationale in the resident’s medical record and indicate the duration for the PRN order.

(5) PRN orders for anti-psychotic drugs are limited to 14 days and cannot be renewed unless the attending physician or prescribing practitioner evaluates the resident for the appropriateness of that medication.

42 C.F.R. § 483.45(e).  The regulation imposes no substantive legal requirement upon a long-term care facility to monitor for or document side effects related to the use of psychotropic medications.  While it may be commonly believed that good nursing practice requires monitoring for and documenting adverse side effects and the effectiveness of medication,37 that requirement is not enforceable as law.38  In this case, however, the documentation that is in the record shows it is more likely than not that Petitioner’s staff was complying with Resident 115’s care plan and monitoring for adverse side effects and the effectiveness of the medications administered, even though they may not have recorded every observation in detail on in a way that CMS might prefer.

I conclude based on the testimony of the surveyors and the documentary evidence presented by CMS, that CMS made a prima facie showing of a violation of 42 C.F.R. § 483.45(e) that posed a risk for more than minimal harm, i.e., noncompliance.  However, after consideration of the entire record, I conclude that Petitioner has rebutted the CMS prima facie case, because Petitioner satisfied its burden to show by a preponderance of the evidence that it was in substantial compliance with the requirements of 42 C.F.R. § 483.45(e) in the example of Resident 115, because the evidence shows it is more likely

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than not that Petitioner’s staff provided adequate monitoring of Resident 115 for side effects of Pamelor® (nortriptyline).

Resident 115, a female, was 71 years old at the time of the survey.  She was originally admitted to Petitioner’s facility on April 9, 2012, and readmitted on October 12, 2016.  Her record of admission lists diagnoses including chronic respiratory failure, dependence on a ventilator, tracheostomy, chronic obstructive pulmonary disease, end stage renal disease requiring renal dialysis, anemia, and major depressive disorder.  CMS Ex. 11; Jt. Stip. ¶ 7; Tr. 56.  A quarterly MDS dated July 25, 2018, indicated Resident 115 could not speak;39 she required limited assistance with activities of daily living, but she was bed bound, also likely due to the need for the ventilator; and she was cognitively intact.  CMS Ex. 10 at 22-24.

Resident 115 had an order dated October 12, 2016, for nortriptyline (Pamelor®) 25 mg every 12 hours for postherpetic neuralgia (nerve pain that is a residual of shingles).  CMS Ex. 10 at 16; Jt. Stip. ¶ 8;40 Tr. 57.  Nortriptyline (Pamelor®) is an anti-depressant, but off-label use for neurogenic pain such as postherpetic neuralgia is well-recognized.  CMS Ex. 8 at 3.  The most frequent side effects of nortriptyline (Pamelor®) in adults include, among others, drowsiness, fatigue, dry mouth, constipation, delayed urination, asthenia, abdominal pain, postural orthostatic hypotension, pharyngitis, weight gain, lethargy, increased alanine aminotransferase indicating possible liver damage, dyspepsia, blurred vision, diaphoresis, impaired concentration, increased appetite, and urinary retention.  Occasional and rare side effects are GI disturbances, photosensitivity, and fine hand tremor.  CMS Ex. 8 at 4; CMS Ex. 39 at 13.

Only the August 2018 MAR for Resident 115 was placed in evidence by CMS.  It shows that Resident 115 received nortriptyline (Pamelor®) as ordered every day in August to August 10, 2018, which I infer is the date that the form was copied for the surveyors.  CMS Ex. 10 at 1; Jt. Stip. ¶ 8.  Generally, MAR forms have a second side on which nurse’s notes may be entered, an example of which is in evidence as CMS Ex. 10 at 15; Tr. 33-34, 83-84.  The nurse’s notes side of the MAR for August 2018 was not placed in evidence by CMS, although Surveyor Abucay-Soller testified that it is normally her practice to request that both sides of forms be copied.  Tr. 84.

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Resident 115’s care plan dated October 18, 2017, listed as a concern or problem that Resident 115 was at risk for adverse reactions related to the use of psychotropic drugs.  The care plan required Petitioner’s staff to monitor Resident 115’s vital signs every shift; monitor for signs of sedation or drowsiness, dry mouth, blurred vision, constipation, tachycardia, postural hypotension; and report any adverse reactions to Resident 115’s physician.  CMS Ex. 10 at 19; P. Ex. J at 1; Jt. Stip. ¶ 8.

Surveyor Abucay-Soller was called to testify by CMS.  Tr. 46; CMS Ex. 4.  Surveyor Abucay-Soller participated in the survey of Petitioner from August 7 through 10, 2018, as survey team leader.  Tr. 50.  She testified that she wrote the part of Tag F758 in the SOD related to Resident 115.  She testified that Resident 115 was identified for investigation by a CMS computer system.  Tr. 52-55.  She testified that her investigation of Resident 115 involved the interview of a nurse who was the RN charge nurse on the adult unit where Resident 115 resided, and review of records including the resident’s record of admission (face sheet), doctor’s orders, the resident’s care plan, the resident’s MAR, and Petitioner’s policy.  Tr. 55-56.  She testified that a nurse she interviewed during the survey told her that monitoring was tracked on the MAR.  However, when she checked the MARs for Resident 115, monitoring was not reflected on the MAR, which caused her to investigate further.  She opined that monitoring for the occurrence or absence of side effects and documenting in some record such as the MAR or nursing notes is the standard of practice.  However, she could not recall whether she reviewed nursing notes for Resident 115.  Tr. 67-70.  On cross-examination Surveyor Abucay-Soller testified that she did not recall reviewing nurse progress notes as part of her investigation.  According to Surveyor Abucay-Soller, if she had reviewed nurse progress notes she would have obtained copies for the file.  Tr. 77-78.  I note that no nurse’s notes or progress notes for Resident 115 were placed in evidence by CMS.  Surveyor Abucay-Soller agreed that although there was no physician order to monitor side effects for nortriptyline,41 the

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resident’s care plan did require monitoring for side effects.  She also agreed that documenting monitoring for side effects could be appropriately done in nursing notes.  Tr. 77-86, 88.  Surveyor Abucay-Soller’s notes from the survey do not show that she reviewed Resident 115’s progress notes or nurse’s notes.  CMS Ex. 7.  Petitioner’s policy for psychotropic medication use does not require documenting adverse reactions on the MAR but simply states they should be properly documented in the resident’s records.  CMS Ex. 9 at 1.  I find that Surveyor Abucay-Soller’s opinions that Petitioner did not document monitoring for side effects related to Resident 115’s use of Pamelor® (nortriptyline) are not weighty.  It is clear the surveyor had limited knowledge because she did not review many documents such as nurse’s notes from the medical record of Resident 115, which she admitted were appropriate places to document monitoring for side effects consistent with Petitioner’s policy.

I accept as weighty Surveyor Abucay-Soller’s opinion that monitoring vital signs is one way of monitoring for possible side effects of medication and vital signs in the normal range may be evidence that there were no adverse side effects.  Surveyor Abucay-Soller testified that she found that nortriptyline (Pamelor®) was necessary for Resident 115 to manage her pain and the medicine needed to be continued with no gradual dose reduction.  Tr. 89-90.  I also accept as weighty her opinion that Resident 115 suffered no actual harm.  Tr. 75, 89.  Surveyor Abucay-Soller testified that the only reason Petitioner was cited for noncompliance related to Resident 115 was the fact that she found no documentation that the resident was monitored for side effects related to nortriptyline (Pamelor®) use.  Tr. 100-01.  She also opined that if nurse’s notes indicate that nortriptyline (Pamelor®) or any medication was administered and no side effects were noted, that would be sufficient.  Tr. 105-06.

RN Rupp testified regarding Resident 115 and the allegation that Petitioner’s staff failed to monitor for adverse side effects following administration of Pamelor® (nortriptyline).  She testified that she expected that Petitioner’s nurses monitor Resident 115 for the side effects of administration of Pamelor® (nortriptyline).  She testified that it was her understanding that monitoring was done.  She testified that any observed or reported side effects would be reported in the nurse’s note for every shift.  The nurse’s note should indicate administration of the medication and any side effects observed or reported.  If there were side effects the physician and family would be notified, and Petitioner’s staff would wait for further orders.  However, when there were no side effects to report, side effects were not reported, and no negative report was entered in the nurse’s notes.  RN Rupp also explained that Resident 115 was alert and capable of telling staff if something was going on with her.  Tr. 428-31, 433.  She testified that she was not aware of Resident 115 having any side effects during the period April through August 2018.  Tr. 432.  RN Rupp’s testimony was fully credible and is supported by the documentary evidence.  P. Exs. D, E, F, G, H, I.

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Petitioner placed in evidence documents Petitioner describes as "Licensed Nurse Progress Notes" (progress notes) for June, July, and August 2018.  P. Exs. D, E, F, respectively.  Petitioner also placed in evidence forms titled "Nursing Narrative Notes" (nurse’s notes) for June, July, and August 2018.  P. Ex. G, H, I, respectively.  The progress notes for June through August 2018, show that nursing staff assessed Resident 115’s vital signs, including temperature, respiration rate, pulse, and blood pressure twice daily.  Nursing staff also performed daily assessments of Resident 115’s pain level, fluid and food intake, and urine and stool output.  The progress notes indicated staff recorded all urine and stool outputs throughout the entire day.  The progress notes also show that Resident 115 was able to verbalize pain sites and pain levels on most days.  P. Exs. D-F.  From June through August 2018, there were only 11 instances where Resident 115 was unable to verbalize her pain.  P. Ex. D at 3, 8, 9, 15, 22, 25-27; P. Ex. E at 6-8; P. Ex. F at 30.  On August 10, 2018, Resident 115 verbalized that she had no pain during both morning and evening assessments.  P. Ex. F at 22.  The fact Resident 115 could verbalize was important because she could report if she perceived that she was experiencing side effects as well as pain.

Nurse’s notes for June through August 2018, show that nursing staff assessed Resident 115 multiple times daily.  In their narratives, Petitioner’s staff documented Resident 115’s overall condition, medication administration, dialysis appointments, and specific notes about her condition, including respiration, pain, urine and stool output, meal and fluid consumption, bowel sounds, skin condition, and whether she was alert and oriented.  For example, staff noted whether Resident 115 displayed any signs and symptoms of pain, distress, or discomfort and whether she was stable and comfortable, tolerated her medications well, had any skin issues, was continent of bowel and bladder, had even and unlabored respiration, and that all her needs were met.  From June through August 2018, Resident 115 often displayed no signs and symptoms of distress, was alert and oriented in four spheres, responded to verbal and tactile stimulation, verbalized needs, tolerated medications well, showed no signs of shortness of breath or other respiratory distress, was continent of bowel and bladder, had no changes in condition, and continued to undergo regular dialysis treatments.  P. Exs. G-I.

Nurse’s notes from June through August 2018, also show that when staff administered medications, staff noted whether the medications were effective and well tolerated.  No adverse side effects are listed in the nurse’s notes.  P. Ex. G at 1-6, 8, 10, 12, 14, 16, 18, 20, 22, 24-26, 29, 31, 32, 34, 37, 38, 41, 42, 44, 47, 49, 50, 53, 55, 57; P Ex. H at 1, 4, 7, 9, 10, 13, 16, 18, 19, 22, 24, 25, 27, 28, 31, 34, 37, 40, 43, 46, 49, 52, 55, 58, 59, 61, 62, 64, 67, 70, 71, 73, 76, 79, 82, 85, 88, 91; P Ex. I at 1, 3, 6, 9, 11, 14, 16, 18, 20, 23, 24.

CMS argues that Surveyor Abucay-Soller testified that it is "standard of care" to note on the MAR that a resident has been assessed for side effects of medication and, if side effects are noted, it would be determined whether they were related to the resident’s psychotropic medication.  CMS Br. at 17.  However, that is not what Surveyor Abucay-

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Soller testified.  Rather, Surveyor Abucay-Soller testified that it is standard of practice to monitor for side effects and "to document it" on the MAR.  She opined in response to my questioning that nurses show that they did monitor for side effects by noting there are no side effects, or if there are side effects, that would be noted along with interventions to address the side effects.  Surveyor Abucay-Soller could not recall where to find the standard of practice she described.  She further agreed in response to my questions that there is no CMS guidance or regulation that requires that monitoring for side effects or that observed side effects be recorded on a MAR and there is no requirement for a MAR in a particular format.  She agreed that monitoring for side effects and the observation of any side effects could be recorded in nursing notes.  Tr. 68-70.

Surveyor Abucay-Sollar’s confusion about what it required is understandable given the lack of clarity of the regulations.  There is no requirement to document monitoring for side effects specified by 42 C.F.R. § 483.45(e) related to use of psychotropic drugs with residents.  Section 483.45(d) of Title 42 provides that an unnecessary medicine is any medicine used without adequate monitoring but does not specify that monitoring be documented.  42 C.F.R. § 483.45(d)(3).  Under 42 C.F.R. § 483.45(d)(5) a medicine is considered unnecessary if its use causes adverse consequences that indicate the dosage of the medicine should be reduced or the medicine eliminated.  Therefore, 42 C.F.R. § 483.45(d)(3) and (5) arguably establish the requirement for a facility to monitor for adverse consequences.  However, the regulation does not impose any substantive legal requirement to document monitoring or the observation of no side effects during monitoring.  Obviously, it is easier for a facility to demonstrate to surveyors that monitoring occurred if it is documented in some way.  Surveyor Abucay-Soller’s suggestion, which has not been shown to be the standard of practice, that the recording of an observation of no side effects shows monitoring was done is an approach.  However, under the regulations there is no such requirement.  The observation of side effects needs to be documented with documentation of any interventions to address the side effects to reflect care and services delivered to a resident, but that is also not specifically required by the regulations.

The requirement to maintain a medical record for each resident is established by 42 C.F.R. § 483.70(i).  The regulation indicates that the medical records should be maintained in accordance with accepted professional standards and practices but does not point to any source for either standards or practices.  The regulation does require that medical records be complete (with no definition of that term), accurately documented, readily accessible, and systemically organized.  42 C.F.R. § 483.70(i)(1).  The minimum requirements established by 42 C.F.R. § 483.70(i)(5) include sufficient information to identify the resident; a record of resident assessments; the resident’s comprehensive plan of care and services provided; the results of any preadmission screenings and review evaluations; physician, nurse, and other licensed professional’s progress notes; and laboratory, radiology, and other diagnostic reports.  The regulation does not specify the

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form for reports or notes or required contents.  CMS policy guidance to surveyors for 42 C.F.R. § 483.70(i) instructs that medical records should:

[R]eflect a resident’s progress toward achieving their person‐centered plan of care objectives and goals and the improvement and maintenance of their clinical, functional, mental and psychosocial status.  Staff must document a resident’s medical and non-medical status when any positive or negative condition change occurs, at a periodic reassessment and during the annual comprehensive assessment.  The medical record must also reflect the resident’s condition and the care and services provided across all disciplines to ensure information is available to facilitate communication among the interdisciplinary team.

The medical record must contain an accurate representation of the actual experiences of the resident and include enough information to provide a picture of the resident’s progress, including his/her response to treatments and/or services, and changes in his/her condition, plan of care goals, objectives and/or interventions.

Except for the annual comprehensive assessment, periodic reassessments when a significant change in status occurs, and quarterly monitoring assessments, regulations do not define the documentation frequency of a resident’s progress. Professional standards of practice however suggests documentation include a resident’s care plan implementation progress.

SOM, app. PP, F842 (rev. 173, eff. Nov. 28, 2017).  CMS instructs surveyors in the SOM that, when assessing the adequacy of a resident’s medical record, they should consider whether the information in the record provides sufficient information for staff to respond to a resident’s needs and changes in status.  The CMS policy applicable to medical records does not expressly require documentation of each instance of monitoring nor state that that is a recognized standard of practice.  The CMS policy also does not require that the absence of adverse effects of treatment including the administration of medications be documented in the medical record.

CMS policy related to the administration of psychotropic drugs under 42 C.F.R. § 483.45(e) is found in the SOM at app. PP, F758 (rev. 173, eff. Nov. 28, 2017) and is in evidence as CMS Ex. 6.  The policy requires monitoring as does the regulation.  The policy is more specific than the regulation and requires monitoring for efficacy and

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adverse consequences.  The policy provides that "[m]onitoring and accurate documentation of the resident’s response to any medication(s) is essential to evaluate the ongoing benefits as well as risks of various medications."  CMS Ex. 6 at 12.  Although the policy emphasizes the importance of monitoring and documenting response to medication, the policy does not specify the form of the documentation or require that the absence of side effects be noted in the medical record.  CMS Ex. 6 at 12-18, 22-23.  Surveyors are instructed by the policy to consider whether the IDT monitored and reported:  (1) response to medication and progress to therapeutic and resident goals, and (2) the emergence of medication related adverse consequences.  CMS Ex. 6 at 24.  Surveyors are not tasked to determine whether staff documented each and every instance a resident was observed to have no side effects to medications.

Petitioner’s policy related to psychotropic medication use requires residents be monitored for any potential adverse reaction to the medication which will be properly documented in the resident’s record.  CMS Ex. 9 at 1.  The policy is not a model of clarity as it is not clear whether the policy requires staff to document the monitoring or the occurrence of adverse reactions to medication.  RN Rupp’s testimony provides necessary clarification as to how the policy was intended to be implemented.  She testified that she expected that Petitioner’s nurses monitor Resident 115 for the side effects and she understood that there was monitoring.  Her testimony indicates that if there were side effects observed, they would be reported in nurse’s notes.  She testified that any side effects would be reported in the nurse’s note for every shift, the physician and family would be notified, and staff would await a further order.  However, when there were no side effects to report, side effects were not reported.  Tr. 428-31, 433.  RN Rupp’s testimony indicates that if there were no side effects observed no side effects were reported which is consistent with interpretation of Petitioner’s policy as requiring documentation of adverse effects but not the absence of side effects to demonstrate that monitoring was done.42

CMS argues that Petitioner has not introduced evidence that its staff specifically monitored for side effects including drowsiness, dry mouth, blurred vision, constipation, increased heart rate, and postural hypertension in accordance with Resident 115’s care plan.  CMS Reply at 7.  Resident 115’s care plan dated October 18, 2017, required Petitioner’s staff to monitor Resident 115’s vital signs every shift; monitor for signs of sedation or drowsiness, dry mouth, blurred vision, constipation, tachycardia, postural

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hypotension; and report any adverse reactions to Resident 115’s physician.  CMS Ex. 10 at 19; P. Ex. J at 1; Jt. Stip. ¶ 8.  Nurse’s notes and progress notes for June through August 2018 placed in evidence by Petitioner show consistent detailed monitoring of Resident 115.  The nurse’s notes also report that when medication was administered it was tolerated well, which is reasonably understood to show that no adverse side effects were observed.  P. Ex. G at 1-6, 8, 10, 12, 14, 16, 18, 20, 22, 24-26, 29, 31, 32, 34, 37, 38, 41, 42, 44, 47, 49, 50, 53, 55, 57; P Ex. H at 1, 4, 7, 9, 10, 13, 16, 18, 19, 22, 24, 25, 27, 28, 31, 34, 37, 40, 43, 46, 49, 52, 55, 58, 59, 61, 62, 64, 67, 70, 71, 73, 76, 79, 82, 85, 88, 91; P Ex. I at 1, 3, 6, 9, 11, 14, 16, 18, 20, 23, 24.  Those nurse’s notes and progress notes plus the testimony of RN Rupp that she understood monitoring was done, are a sufficient basis for me to infer that Resident 115 was in fact monitored for any side effects from taking Pamelor® (nortriptyline).

I find that the evidence, including the medical records for Resident 115 and the testimony of RN Rupp, shows that it is more likely than not that Petitioner’s staff monitored Resident 115 for side effects from the use of Pamelor® (nortriptyline).  The absence of side effects may not have been recorded in Resident 115’s medical record in a way preferred or expected by the surveyors or CMS.  However, I conclude that there is no substantive legal requirement for long-term care facilities to record that no side effects were observed in any particular manner and no CMS policy establishes a standard for such entries.

Accordingly, I conclude that the example of Resident 115 involved no violation of 42 C.F.R. § 483.45(e).

### III.  Conclusion

For the foregoing reasons, I conclude that there were no violations of statutory or regulatory participation requirements that posed a risk for more than minimal harm cited by the survey of Petitioner completed on August 10, 2018; there was no noncompliance; and there was no basis for the imposition of an enforcement remedy.

----

### Endnotes

1  References are to the 2017 revision of the Code of Federal Regulations (C.F.R.), unless otherwise stated.  The C.F.R. revision in effect when a survey was conducted applies in long-term care survey and certification cases.  *Good Shepard Home for the Aged, Inc.,* DAB No. 2858 at 1 n.1 (2018); *Carmel Convalescent Hosp.*, DAB No. 1584 at 2 n.2 (1996).

2  This is a "Tag" designation as used in CMS Pub. 100-07, State Operations Manual (SOM), app. PP – Guidance to Surveyors for Long Term Care Facilities.  The current version of the SOM is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items/CMS1201984.  The "Tag" refers to the specific regulatory provision allegedly violated and CMS’s policy guidance to surveyors.  Although the SOM does not have the force and effect of law, the provisions of the Act and regulations interpreted clearly do have such force and effect. * Ind. Dep’t of Pub. Welfare v. Sullivan*, 934 F.2d 853 (7th Cir. 1991); *Nw. Tissue Ctr. v. Shalala*, 1 F.3d 522 (7th Cir. 1993).  Thus, while the Secretary may not seek to enforce the provisions of the SOM, the Secretary may seek to enforce the provisions of the Act or regulations as interpreted by the SOM.

3  SNFs and nursing facilities (NFs) are often referred to as long-term care facilities or nursing homes.  NF participation in Medicaid is governed by section 1919 of the Act.  Section 1919(h)(2) of the Act gives enforcement authority to the states to ensure that NFs comply with their participation requirements established by sections 1919(b), (c), and (d) of the Act.

4  Congress granted the Secretary authority to impose enforcement remedies for noncompliance.  Act § 1819(h)(2).  The Secretary is authorized to impose CMPs as an enforcement remedy by section 1128A of the Act.  CMPs are imposed by CMS with delegated authority of the Secretary.  42 C.F.R. § 488.2.  Pursuant to subsection 1128A(j) of the Act, section 205 of the Act is applicable to the imposition of CMPs, and that section is applicable to the imposition of CMPs by both the Secretary and the Commissioner of Social Security under the authority of section 1128A of the Act.  The Inspectors General (IGs) for both HHS and the Social Security Administration (SSA) also exercise delegated authority to impose CMPs pursuant to section 1128A of the Act.  Both IGs engaged in rulemaking to specify the allocation of the burden of persuasion and the quantum of evidence required when proceeding upon a case involving a CMP.  Both the SSA IG and the HHS IG imposed upon the government in CMP cases the burden of persuasion on all issues other than affirmative defenses and mitigating factors for which the burden is upon the nongovernmental party.  The regulations of the IGs for SSA and HHS provide that the burden of persuasion is to be judged by a preponderance of the evidence.  20 C.F.R. § 498.215(b), (c); 42 C.F.R. § 1005.15(b), (d).  CMS failed to promulgate a regulation like those of the HHS and SSA IGs and the Board has filled the gap with its interpretative rules allocating the burden of persuasion to the nongovernmental party, the party defending against the imposition of the CMP.

5  "Credible evidence" is evidence that is worthy of belief.  *Black**‘**s Law Dictionary* 596 (18th ed. 2004).  The "weight of evidence" is the persuasiveness of some evidence compared to other evidence.  *Id*. at 1625.

6  Scope and severity levels are used by CMS and a state when selecting remedies.  The scope and severity level is designated by an alpha character, A through L, selected by CMS or the state agency from the scope and severity matrix published in the SOM, ch. 7, § 7400E.  A scope and severity level of A, B, or C indicates a deficiency that presents no actual harm but has the potential for minimal harm, which is an insufficient basis for imposing an enforcement remedy.  Facilities with deficiencies of a level no greater than C remain in substantial compliance.  42 C.F.R. § 488.301.  A scope and severity level of D, E, or F indicates a deficiency that presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy.  A scope and severity level of G, H, or I indicate a deficiency that involves actual harm that does not amount to immediate jeopardy.  Scope and severity levels J, K, and L are deficiencies that constitute immediate jeopardy to resident health or safety.  The matrix, which is based on 42 C.F.R. § 488.408, specifies which remedies are required and optional at each level based upon the frequency of the deficiency.

7  CMS imposed a PICMP and no other enforcement remedies.  CMS Ex. 2 at 2.  Therefore, the period or duration of the alleged noncompliance is not in issue, as any single instance of noncompliance during the period examined by the survey could be an adequate basis for an enforcement remedy.  In the case of Resident 45, CMS focuses primarily on facts related to her admission to Petitioner from Children’s Hospital Los Angeles (Children’s) on April 3 through August 10, 2018, the date of the survey.  CMS Br. at 12; CMS Reply at 5-6.  However, CMS also urges my consideration of evidence of Resident 45’s treatment after the survey.  CMS Br. at 13; CMS Reply at 6.  CMS does not clearly indicate the period of concern related to Resident 115 and Petitioner’s alleged failure to monitor the resident for side effects of medication.  CMS Br. at 16-18; CMS Reply at 7-8.  As part of my de novo review in this case, I consider all the evidence admitted to the record and the entire period covered by that evidence rather than limiting my review to a single period or point in time.

8  "Clinical record" is referred to in 42 C.F.R. § 483.45(e)(1) and (3).  "Medical record" is referred to in 42 C.F.R. § 483.45(e)(4).  What is the difference?  Pursuant to 42 C.F.R. § 483.70(i), Petitioner is required to maintain a "medical record" for each resident, with specific contents, protection, and retention requirements specified in the regulation.  The regulations at 42 C.F.R. pt. 483 do not require that a long-term care facility create or maintain a "clinical record" for a resident or define the term "clinical record."  In fact, there are only five occurrences of the term "clinical record" in 42 C.F.R. pt. 483.  Congress required that Petitioner maintain "clinical records" for all residents.  Act §§ 1819(b)(6)(C) and 1919(b)(6)(C) of the Act.  Sections 1819 and 1919 of the Act do not include the term "medical records."  For purposes of this decision, I conclude that "clinical record" and "medical record" are synonymous as did CMS when drafting the regulation.  81 Fed. Reg. 68,688, 68,711, 68,720, 68,788 (Oct. 4, 2016).

9  Each resident’s care plan is developed by the resident’s IDT, which includes the resident’s physician, a registered nurse responsible for the resident, a nurse aide with responsibility for the resident, a member of food and nutrition services staff, the resident and/or resident’s representative, and other staff or professionals based on the resident’s needs.  42 C.F.R. § 483.21(b)(2)(ii).

10  Dr. Salinas was a member of Children’s Division of Pulmonary Medicine.  Tr. 167.

11  Surveyor Ekeomodi testified that she asked that Petitioner provide Resident 45’s clinical records and subsequently requested additional records, specifically behavioral documentation, activities records, medication administration records, and some Children’s records.  She recalled that Petitioner had some of the Children’s records but also requested that Children’s provide additional records.  She could not identify which Children’s records were held by Petitioner and which were sent to Petitioner when the request was made to Children’s.  Tr. 317-18.  She testified that among the records she reviewed at Petitioner were records from Children’s.  Tr. 263.

12  I find the records of Children’s credible and entitled to great weight in this case as they are contemporaneously made, detailed, and completed for the purpose of providing care to Resident 45.  The records are, however, not perfect.  There are inconsistencies or possible errors in the medical records from Children’s.  Information summarized in this decision should be considered my findings based on my review of the records available to me.  Not every inconsistency or possible error is specifically identified and explained as those facts, while relevant, do not affect the outcome, i.e., are not material, to the extent that if the fact did not exist or was determined to be different, it would not cause a different decision.  A couple of examples of possible errors in the records are the date of Resident 45’s first admission to Children’s (some documents show her transfer to Children’s on October 18, 2016, which was 10 days before she was born (CMS Ex. 35 at 129, 224, 227)), and variations in medication lists from the various Children’s departments involved in Resident 45’s care.

13  Weaning, tapering, and gradual dose reduction are treated as being synonymous.  According to CMS policy a gradual dose reduction "is the stepwise tapering of a dose to determine if symptoms, conditions, or risks can be managed by a lower dose or if the dose or medication can be discontinued."  CMS Ex. 6 at 4, 18-19.  Dr. Brook testified that gradual dose reduction is typically called weaning.  Tr. 163.

14  Resident 45’s physician was listed in the Children’s record as Mark Barrett, MD and he is noted not to be a staff physician at Children’s.  CMS Ex. 35 at 158.  It is not clear whether the reference to him as Petitioner’s physician meant that he was Petitioner’s medical director or simply Resident 45’s treating physician.  Dr. Barrett’s employment is not material to this decision.

Dr. Barrett is listed as Resident 45’s physician on Petitioner physician’ orders sheets from June 2017.  CMS Ex. 14 at 10-11.  The record reflects that Dr. Sally Ward was Resident 45’s physician and she ordered Resident 45’s prescriptions in March 2018.  CMS Ex. 14 at 9.  Dr. Danieli Salinas was listed as Resident 45’s physician and ordered Resident 45’s prescriptions from April 3 through August 8, 2018.  CMS Ex. 14 at 1-8.

15  Petitioner’s Psychopharmaceutical Summary Sheet for Resident 45 for October, November, and December 2017, shows that from November 21 to December 19, 2017, Resident 45 was being weaned from Ativan® (lorazepam).  CMS Ex. 26 at 5.

16  CMS placed in evidence copies of physician orders sheets obtained from Petitioner during the survey for the period May 22, 2017 through August 8, 2018.  CMS Ex. 14.  Because the exhibit includes only 11 pages, it is doubtful that all orders for Resident 45 for that period are included.  It appears, for example that the order dated May 22, 2017, is incomplete.  CMS Ex. 14 at 11.  Further, no orders are listed with dates between June 12, 2017 and March 19, 2018.  CMS Ex. 14 at 9-10.

17  CMS argues that Dr. Salinas not Dr. Brook was Resident 45’s treating physician who ordered the administration of Ativan® (lorazepam) and Seroquel® (quetiapine) during the period April through August 2018.  CMS asserts that Dr. Brook’s testimony should be given little weight for this reason.  CMS Br. at 8.  However, CMS ignores the clear evidence that Dr. Brook was part of Resident 45’s team of physicians at Children’s with Dr. Salinas and she was knowledgeable of the resident’s care and treatment.  Although Dr. Brook did not issue the prescriptions for Ativan® (lorazepam) and Seroquel® (quetiapine), her testimony shows that she was one of Resident 45’s treating physicians who decided that both prescriptions were necessary to control Resident 45’s agitation.  Tr. 141-47, 165-66, 198.

18  Dr. Brook identified Sally Ward as a physician who is the chief of the division of pulmonary and sleep medicine at Children’s and the pediatric medical director at Petitioner.  She testified that Dr. Ward did rounds at Petitioner seeing every patient at least twice per week.  Tr. 155-58.  She agreed that Dr. Salinas, a member of Children’s Division of Pulmonary Medicine, was Resident 45’s primary care physician in 2018, and it was usual for her to issue orders for medications and treatments.  Tr. 167-68.

19  Off-label means that a medicine is prescribed for a use not approved by the FDA.  The FDA explains that "[f]rom the FDA perspective, once the FDA approves a drug, healthcare providers generally may prescribe the medicine for an unapproved use [off-label] when they judge that it is medically appropriate for their patient."  Https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label (last visited Oct. 28, 2022).  Therefore, off-label use is consistent with the standard of care.  Indeed, the Agency for Healthcare Research and Quality, which is part of HHS, points out that not only is off-label prescribing legal, it is common with one in five prescriptions written for off-label use.  Https://www.ahrq.gov/patients-consumers/patient-involvement/off-label-drug-usage.html (last visited Oct. 28, 2022).  Surveyor Ekeomodi testified incorrectly that off-label use means that a medication is used for a purpose not approved by the manufacturer.  She also did not know whether any federal regulation prohibited off-label prescribing but she was not aware of any.  Tr. 331-34.

20  The World Health Organization (WHO) established the ICD more than a century ago for global reporting of the extent, causes, and consequences of human disease, and death.  Https://www.who.int/standards/classifications/classification-of-diseases (last visited Sep. 7, 2022).

21  Dr. Brook clarified on cross-examination that the terms agitated, irritable, and restless are ambiguous when used by parents and other laypeople.  Tr. 187-88.

22  What are behavioral interventions?  The term is not defined in the regulations.  However, CMS provided a definition in the SOM.

*"**Behavioral interventions**" are individualized, non-pharmacological approaches to care that are provided as part of a supportive physical and psychosocial environment, directed toward understanding, preventing, relieving, and/or accommodating a resident’s distress or loss of abilities, as well as maintaining or improving a resident’s mental, physical or psychosocial well-being.*

CMS Ex. 6 at 3 (italics and bold in original).  For purposes of this decision, consistent with the CMS policy, I construe the term broadly to include all nonpharmacologic interventions.

23  There is evidence that Petitioner’s staff provided many activities and opportunities for human interaction to Resident 45 in accordance with her care plan.  The record shows that Petitioner’s staff provided daily interaction and age-appropriate activities in accordance with the April 6, 2018 Care Plan, May 28, 2018 Child Life Development Assessment, and June 7, 2018 Pediatric Initial Assessment.  Activity progress notes show staff visited Resident 45 at bedside daily and provided a variety of activities including reading, music, movies, educational videos, one-way conversation, toys, tactile stimulation, holding, rocking, and massages of the head, shoulders, and arms.  CMS Ex. 21 at 1-6.  Pediatrics activity participation records showed that Petitioner’s staff performed one-to-one room visits and at least one other type of activity, such as tactile or touch stimulation, holding and rocking, talking, reading, singing, and playing music daily.  The record also showed that Resident 45 occasionally watched TV or movies and played with toys.  CMS Ex. 25 at 1, 3; P. Ex. A at 38.  The evidence shows that Resident 45 often responded positively and enjoyed the daily interaction and activities Petitioner’s staff provided.  A Pediatric Sub-Acute Psychosocial Evaluation dated April 4, 2018, stated Resident 45 enjoyed being rocked to sleep.  CMS Ex. 18.  Activity progress notes indicated that Resident 45 responded to activities with eye movements.  CMS Ex. 21 at 1-6.  A Child Life Development Assessment dated May 28, 2018, showed that Resident 45 loved to sit in her wheelchair and bouncer and be propped up using her "boppy" pillow but could not sustain visual tracking.  Resident 45 was able to lift her arm and swing it to the side and could smile and follow familiar sounds.  Resident 45 smiled and cried to have her needs met.  CMS Ex. 17 at 3-4.  A nursing narrative note dated June 13, 2018, stated that Resident 45 was responsive to tactile stimuli.  P. Ex. K at 8.

CMS placed in evidence quarterly and annual child life development assessment forms for Resident 45 obtained during the survey.  The forms are dated August 31, 2017 through May 28, 2018.  CMS Ex. 17.  The forms show that bedside activities and rocking and holding were used to meet play and recreation needs on August 31, 2017 (quarterly report), February 28, 2018 (quarterly report), and May 28, 2018 (annual report).  CMS Ex. 17 at 2, 4, 6.

It should be noted however that the activities discussed were therapy and not necessarily behavioral interventions to control episodes of agitation and/or irritability.  The evidence should not be considered as showing that such interventions were successful in addressing Resident 45’s agitation and/or irritability as the activities were not offered for that purpose in most cases according to the record and were not often effective when employed for that purpose.

24  CMS explains that "adverse consequence" is a broad term that refers to "unwanted, uncomfortable, or dangerous effects that a drug may have, such as impairment or decline in an individual’s mental or physical condition or functional or psychosocial status."  CMS Ex. 6 at 3.  "A side effect is an expected, well-known reaction that occurs with a predictable frequency and may or may not constitute an adverse consequence."  CMS Ex. 6 at 3.  Section 483.45(e) of Title 42 does not require monitoring for either adverse consequences or side effects.  In this decision the term "side effect" is used as the term is broad enough to include both positive and negative consequences of the use of medications.

25  PRN Ativan® (lorazepam) was ordered following the November and December 2017 wean on January 10, 2018, for agitation manifested by tachycardia, tachypnea, and crying.  CMS Ex. 20 at 33.

26  After the wean from Seroquel® (quetiapine) 6.25 mg every 8 hours (CMS Ex. 20 at 28) to twice per day, the MAR reflects a significant number of PRN doses of Ativan® (lorazepam) were required for agitation in March 2018 (CMS Ex. 20 at 34).  Nurses notes also reflect increased agitation during that period.  CMS Ex. 29 at 5, 11, 17, 26, 29, 32, 65, 68-69, 71-72, 74-75, 77.  On April 3, 2018, the order was given to return to 6.25 mg of Seroquel® (quetiapine) three times per day (every 8 hours).  CMS Ex. 20 at 10.

27  While it may be commonly accepted that good nursing practice requires documenting adverse side effects and the effectiveness of medication, that requirement is not established as a substantive legal requirement by the regulations and is not enforceable as law.  I do not suggest however, that failure to monitor or assess a resident’s response to medication could not be cited as a violation of another regulatory participation requirement such as quality of life or quality of care, for example, for which the absence of documentation may be evidence of failure to deliver necessary care and services that meet professional standards of care.  However, Petitioner was not cited for violation of such regulations either intentionally or by omission.

28  CMS argues that Dr. Brook’s testimony does not help Petitioner meet its burden because her testimony does not satisfy the documentation requirements of 42 C.F.R. § 483.45(e) for the use of psychotropics.  CMS Br. at 7-8.  Documentation in a resident’s medical record related to the use of psychotropics is required by 42 C.F.R. § 483.45(e)(1), (3), (4).  The regulation does not specify the form of the documentation and no particular form is prescribed for resident medical records required by 42 C.F.R. § 483.70(i)(1).  CMS does require the use of the MDS for the resident assessments required by 42 C.F.R. § 483.20(a).  However, the MDS in evidence for Resident 45 does not include information required to be documented by 42 C.F.R. § 483.45.  Except for the MDS, the form and content of resident medical records are left to long-term care facility discretion, so long as the general requirements of 42 C.F.R. § 483.70(i)(1) are satisfied.  Petitioner was not cited for noncompliance based on a violation of 42 C.F.R. § 483.70(i).  CMS Ex. 1.  Dr. Brook’s testimony is no substitute for proper documentation.  However, Dr. Brook’s testimony is considered weighty evidence that clarifies existing documentation in Resident 45’s medical record.  There can be no dispute that long-term care facilities should document a resident’s medical record as thoroughly as possible, not to satisfy CMS, but to ensure that needed care and services are provided to the resident.  Of course, a facility may also avoid some citations of noncompliance by thorough documentation in a form that is legible and understandable to surveyors and CMS.  However, it is not reasonable to hold a facility to a standard not established and articulated by CMS regarding documentation.  In this case, the documents and testimony show that the substantive legal requirement for documentation under of 42 C.F.R. § 483.45(e) was, in fact, satisfied even though CMS and the surveyors did not find a form with the exact content they sought.  Because CMS does not specify forms to be used, except the MDS, CMS and the surveyors cannot avoid the need to evaluate all the evidence to determine whether noncompliance occurred rather than simply citing noncompliance because they did not readily find a document in their ideal or expected format.

29  CMS and surveyor allegations that the psychotropics were not prescribed for a diagnosed specific condition identified in the resident’s medical record in violation of 42 C.F.R. § 483.45(e)(3), have been rejected for the reasons discussed above.

30  It is helpful to know that 42 C.F.R. § 483.45(c)(1) requires that a licensed pharmacist review a resident’s medicine regime, including the resident’s medical record, every 30 days.  The reviewing pharmacist must notify the attending physician of the resident and the medical director of any irregularities.  I infer that the pharmacist in this case was alerting Resident 45’s physician to the fact that he could find no evidence Resident 45’s physician reevaluated the PRN orders for Seroquel® (quetiapine) and Ativan® (lorazepam) every 14 days, with two 14-day periods having elapsed between Resident 45’s readmission to Petitioner on April 3, 2018 and early May 2018.

31  The policy provides no clue how a facility is to ensure that every 14 days an attending physician or prescribing practitioner will directly examine a resident before issuing a new order.  The policy is impracticable and unworkable because a long-term care facility cannot compel action by a physician who is not an employee or contractor of the facility.

32  Except for the MDS and related forms, CMS does not prescribe the forms long-term care facilities use to track care and services delivered to residents, such as for example, MARs, orders, notes, assessments, and the like.

33  The evidence does not show that Dr. Salinas was Petitioner’s medical director as an employee or contractor.  The evidence shows only that Dr. Salinas was a physician at Children’s who was also Resident 45’s attending physician beginning in the spring of 2018.  Because Dr. Salinas was not Petitioner’s medical director and not an employee or contractor of Petitioner, 42 C.F.R. § 483.45(e)(4) and (5) cannot be enforced against Dr. Salinas and CMS has no ability to compel her to comply with the regulation.

34  Treating the policy as establishing a rebuttable presumption is consistent with the fact that the regulations require that surveys be outcome based.  42 C.F.R. § 488.26(c)(2).

35  Even if the clearly erroneous standard was incorrectly found to apply to the determination of whether Petitioner rebutted the CMS prima facie showing that Petitioner’s violation of 42 C.F.R. § 483.45(e)(4) and (5) posed a risk for more than minimal harm, I conclude that Petitioner meets the higher burden and the CMS prima facie showing has been rebutted.  The clearly erroneous standard is not defined by the Secretary in 42 C.F.R. pts. 488 or 498.  The "clearly erroneous standard" is described in Black’s Law Dictionary as a standard of appellate review applied in judging the trial court's treatment of factual issues, under which a factual determination is upheld unless the appellate court has the firm conviction that an error was committed. Black’s Law Dictionary 269 (8th ed. 2004).  The United States Supreme Court has addressed the "clearly erroneous standard" in the context of the federal APA.  The Court described the preponderance of the evidence standard, the most common standard, as requiring that the trier-of-fact believe that the existence of a fact is more probable than not before finding in favor of the party that had the burden to persuade the judge of the fact’s existence.  *In re Winship*, 397 U.S. 358, 371-72 (1970); *Concrete Pipe & Prods. of Cal., Inc. v. Constr. Laborers*, 508 U.S. 602, 622 (1993).  The "substantial evidence" standard considers whether a reasonable mind might accept a particular evidentiary record as adequate to support a conclusion.  *Consol. Edison*, 305 U.S. 197, 229 (1938); *Dickinson v. Zurko*, 527 U.S. 150, 162 (1999).  Under the "clearly erroneous" standard, a finding is clearly erroneous even though there may be some evidence to support it if, based on all the evidence, the reviewing judge or authority has a definite and firm conviction that an error has been committed.  *United States v. U.S. Gypsum Co.*, 333 U.S. 364, 395 (1948); *Dickinson*, 527 U.S. at 162; *Concrete Pipe*, 508 U.S. at 622.  Based on my review of the evidence, I have a definite and firm conviction that the CMS conclusion that the regulatory violation of 42 C.F.R. § 483.45(e)(4) and (5) posed a risk for more than minimal harm is clearly erroneous.

36  The SOD alleges that Resident 115 was monitored for side effects.  CMS Ex. 1 at 72.  Surveyor Abucay-Soller, who drafted the allegation of noncompliance in the example of Resident 115, testified that she inadvertently omitted the word "not."  She testified that the allegation she intended was that Petitioner did not give the surveyors documentation showing that Resident 115 was monitored for side effects.  She testified that was the only basis for the deficiency citation.  Tr. 100-01.

37  CMS discusses the importance of adequate monitoring in the SOM.  CMS Ex. 6 at 5-8, 10-17, 22-24.

38  I am not suggesting that failure to monitor or assess a resident’s response to medication could not be cited as a violation of another regulatory participation requirement such as quality of life or quality of care, for example, for which the absence of documentation may be evidence of failure to deliver necessary care and services.  However, Petitioner was not cited for violation of such regulations.

39  RN Rupp testified however, that Resident 115 was verbal and called her on the telephone.  Tr. 432-33.  I need not resolve this inconsistency to decide this case.

40  The parties stipulated incorrectly that the nortriptyline (Pamelor®) was prescribed for depression.  Jt. Stip. at 8.

41  Surveyor Abucay-Soller opined that Petitioner needed a physician’s order to monitor for side effects of nortriptyline (Pamelor®) and that it was standard of practice to have such an order.  She also opined that Petitioner’s policy required a physician’s order to monitor for side effects.  Tr. 75-77, 103-04.  I do not find her opinion weighty.  Surveyor Abucay-Soller overlooks the fact that each resident’s care plan is developed by the resident’s IDT, which includes the resident’s physician, a registered nurse responsible for the resident, a nurse aide with responsibility for the resident, a member of food and nutrition services staff, the resident and/or resident’s representative, other staff or professionals based on the resident’s needs.  42 C.F.R. § 483.21(b)(2)(ii).  Therefore, obtaining a separate physician’s order to monitor for side effects is an unnecessary act if the requirement for monitoring is included in the resident’s care plan.  Petitioner’s policy in evidence does not require obtaining a physician’s order to monitor for side effects.  CMS Ex. 9 at 1.

42  Noting that a medicine has been administered and no side effects were observed on the MAR, in nurse’s notes, or other appropriate document in a resident’s medical record, may make it easier for a facility to address surveyor concerns about whether monitoring was done.  However, because CMS has not specified the use of certain forms or entries to be made on those forms, other entries should be equally acceptable such as "medication was well tolerated."

Keith W. SickendickAdministrative Law Judge