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                              West Caldwell Care Center, DAB CR5783 (2020)
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West Caldwell Care Center, DAB CR5783 (2020)








  
  
    

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





West Caldwell Care Center
(CCN: 31-5247),
Petitioner,

v.

Centers for Medicare & Medicaid Services.
Docket No. C-17-100Decision No. CR5783December 21, 2020

        
              
    

      DECISION

Petitioner, West Caldwell Care Center, appealed the determination by the Centers for Medicare & Medicaid Services (CMS) that it was not in substantial compliance with the Medicare program participation requirement related to accidents, 42 C.F.R. § 483.25(h), which posed immediate jeopardy to resident health and safety.  CMS imposed a per-day civil money penalty (CMP) of $10,391 for one day of immediate jeopardy, which was later changed to a $7,550 per-instance CMP after Petitioner requested a hearing before an Administrative Law Judge (ALJ).  Petitioner challenges CMS' immediate jeopardy finding, the change of remedy, imposition of the CMP, and the amount of the CMP.  CMS moved for summary judgment.  Petitioner opposed summary judgment, arguing that genuine issues of material fact are highly disputed.  For the reasons explained below, Petitioner does not have the right to administrative review of CMS' immediate jeopardy finding or CMS' change of remedy.  I also conclude that there is no genuine dispute as to any material fact, and CMS is entitled to judgment as a matter of law.  Viewing the facts in the light most favorable to the non-moving party, I conclude that Petitioner was not in substantial compliance with the Medicare participation requirement and the $7,550 per-instance CMP imposed by CMS is reasonable.  Therefore, I grant CMS' motion for summary judgment and affirm CMS' determination.

**Page 2**

I.  Background and Procedural History

**A. Regulatory Framework**

The Social Security Act (Act) establishes requirements for a skilled nursing facility (SNF) to participate in the Medicare program and authorizes the Secretary of Health and Human Services (the Secretary) to promulgate regulations implementing those statutory provisions.  42 U.S.C. §§ 1395i-3, 1395hh.  To participate in the Medicare program, a SNF must maintain "substantial compliance" with the requirements at 42 C.F.R. Part 483, subpart B.  42 U.S.C. § 1395i-3(b)-(d); 42 C.F.R. § 488.301.  To be in substantial compliance, a SNF's "deficiency," defined as a failure to meet a participation requirement established by the Act or the Secretary's regulations, may "pose no greater risk to resident health or safety than the potential for causing minimal harm."  42 C.F.R. § 488.301.  "Noncompliance" means "any deficiency that causes a facility to not be in substantial compliance."  *Id.*

The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with Medicare participation requirements.  42 U.S.C. § 1395aa(a); 42 C.F.R. §§ 488.10(a), 488.20.  State agencies also investigate complaints that SNFs have violated the Medicare participation requirements.  42 U.S.C. § 1395i–3(g)(4); 42 C.F.R. § 488.332(a).1
  CMS may impose enforcement remedies against SNFs that are not in substantial compliance with one or more participation requirements.  42 U.S.C. § 1395i-3(h)(2); 42 C.F.R. §§ 488.400, 488.402(b)-(c), 488.406.  The purpose of imposing remedies is to ensure prompt compliance with program requirements.  42 C.F.R. § 488.402(a).  When selecting enforcement remedies, CMS considers the "seriousness" of the SNF's deficiencies (i.e., the level of noncompliance).  42 C.F.R. § 488.404(a).  The seriousness of the deficiency is based on its severity (i.e., whether the noncompliance has created a "potential for more than minimal harm," resulted in "actual harm," or placed residents in "immediate jeopardy") and scope (i.e., whether the noncompliance is "isolated," constitutes a "pattern," or is "widespread").  42 C.F.R. § 488.404(b).  "Immediate jeopardy" exists when "the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident."  42 C.F.R. § 488.301.

The scope and severity levels of deficiencies are designated by letters "A" through "L" and have been placed in a matrix published in the State Operations Manual (SOM).  SOM, CMS Pub. 100-07, ch. 7, § 7400.5.1 (Rev. 63, effective Sept. 10, 2010) (applicable table at the time of the survey at issue) (pursuant to Rev. 185, issued November 16, 2018,

**Page 3**

the matrix currently appears at § 7400.3.1 of the SOM, but the substance is largely unchanged).  Relevant here, a scope and severity level of "L" is the highest level deficiency, which indicates widespread immediate jeopardy to resident health or safety.  *See id.*  A deficiency is considered "widespread" when the deficiency is "pervasive (affect many locations) throughout the facility and/or represent[s] a systemic failure that affected, or has the potential to affect, a large portion or all of the residents or employees."  SOM, ch. 7, § 7410.2.1.Also relevant here, a scope and severity level of "E" represents a pattern that presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy.  SOM, ch. 7, § 7400.5.1.  A "pattern" exists when "more than a very limited number of residents or employees are affected, and/or the situation has occurred in more than a limited number of locations but the locations are not dispersed throughout the facility."  SOM, ch. 7, § 7410.2.1.

Among other enforcement remedies, CMS may impose a per-day CMP for the number of days a SNF is not in substantial compliance or a per-instance CMP for each instance of the SNF's noncompliance, regardless of whether or not the deficiencies constitute immediate jeopardy.  42 C.F.R. § 488.430(a).  A per-day CMP may range from either $50 to $3,000 per day for less serious noncompliance, or $3,050 to $10,000 per day for more serious noncompliance that poses immediate jeopardy to the health and safety of residents.  42 C.F.R. § 488.438(a)(1).  The per-day CMP may accrue until the facility achieves substantial compliance or its provider agreement is terminated.  42 C.F.R. § 488.454(a).  The authorized range for a per-instance CMP is $1,000 to $10,000, regardless of whether the deficiencies constitute immediate jeopardy.2
  42 C.F.R. § 488.438(a)(2).  The per-instance CMP is a fixed amount imposed for the particular instance of noncompliance.  42 C.F.R. § 488.454(d).

A SNF may request a *de novo* hearing before an ALJ to challenge a noncompliance finding that led to the imposition of an enforcement remedy, such as a CMP.  42 U.S.C. §§ 1320a-7a(c)(2), 1395i-3(h)(2)(B)(ii), 1395cc(h)(1); 42 C.F.R. §§ 488.408(g)(1), 488.434(a)(2)(viii), 498.3(b)(13); *see also* *CarePlex of Silver Spring*, DAB No. 1683 (1999) (holding that ALJs hold *de novo* hearings based on issues permitted under the regulations and ALJ review is not a quasi-appellate review); *Claiborne-Hughes Health Ctr. v. Sebelius*, 609 F.3d 839, 843 (6th Cir. 2010) (stating that the Departmental Appeals Board (Board) "reviewed the finding under the de novo standard that the ALJ would have

**Page 4**

applied"); *Columbus Park Nursing* & *Rehab. Ctr.* *v. Sebelius*, 940 F. Supp. 2d 805, 817-818 (N.D. Ill. 2013) (finding that the court lacked jurisdiction where the ALJ and Board also lacked jurisdiction because CMS had not imposed an enforcement remedy).  The scope of ALJ review includes the finding of noncompliance and whether the amount of the CMP is reasonable.  42 C.F.R. §§ 488.408(g)(1), 488.438(e)-(f).  However, CMS' choice of remedies and the factors CMS considered when choosing remedies are not subject to review.  42 C.F.R. §§ 488.408(g)(2), 498.3(b)(13).  A determination with respect to the level of noncompliance may be appealed only if a successful challenge on this issue would affect the range of CMP amounts that CMS could collect or if CMS has made a finding of substandard quality of care that results in the loss of approval of a facility's nurse aide training and competency evaluation program (NATCEP).3
  42 C.F.R. §§ 498.3(b)(14), (d)(10)(i)-(ii).  On review, CMS' determination of the level of noncompliance must be upheld unless it is clearly erroneous.  42 C.F.R. § 498.60(c)(2).

As to the burdens of proof, CMS has the burden to produce evidence sufficient to make a *prima facie* case that Petitioner is out of substantial compliance with Medicare participation requirements and has a basis to impose an enforcement remedy.  *See, e.g.,* *Evergreene Nursing Care Ctr.*, DAB No. 2069 at 7 (2007).  If CMS makes this *prima facie* showing, then Petitioner bears the ultimate burden of persuasion as to whether it substantially complied with the participation requirements.  Petitioner has both the burden of coming forward and the burden of persuasion as to any affirmative defense or rebuttal evidence.  To prevail, Petitioner must show by a preponderance of the evidence on the record as a whole that it was in substantial compliance with Medicare participation requirements.  *Id.* at 7-8; *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 (2005).

**B. Petitioner's Request for Hearing**

Petitioner is a SNF located in West Caldwell, New Jersey, that participates in the Medicare program.  On March 27, 2015, surveyors from the New Jersey Department of Health (state agency) completed an unannounced survey of eight complaints at Petitioner's facility.  CMS Exhibit (Ex.) 3 at 1; P. Ex. 3 at ¶ 4; CMS Ex. 20 at ¶ 4.  As a result of that complaint survey, the state agency found that Petitioner was not in substantial compliance with the Medicare participation requirement related to accident hazards, supervision, and devices because windows were not restricted to prevent patient elopement or suicide, which posed immediate jeopardy to resident health and safety and

**Page 5**

constituted substandard quality of care.4
  CMS Ex. 4 at 1, 3-4; CMS Ex. 3 at 1-7 (citing Petitioner for a deficiency under 42 C.F.R. § 483.25(h), Tag F323, relating to accident hazards, supervision, and devices, at the "L" scope and severity level5
).  The state agency also determined that Petitioner was not in substantial compliance with the participation requirement related to pharmacy services/consultation, labeling, and storage of drugs, and biological substances.  CMS Ex. 3 at 7-10 (citing Petitioner under 42 C.F.R. § 483.60(b), (d), and (e), Tag F431, relating to pharmacy services/consultation, labeling, and storage of drugs and biological substances, at the "E" scope and severity level).6
  Specifically, the state agency determined that facility staff failed to follow proper procedures for the use of sterile normal saline solution, which caused no actual harm but had the potential for causing more than minimal harm that does not amount to immediate jeopardy.  *Id.*  Petitioner corrected the immediate jeopardy and substandard quality of care conditions on March 27, 2015, and a revisit survey determined that Petitioner achieved substantial compliance as of May 20, 2015.  CMS Ex. 1 at 1; CMS Ex. 5 at 1.

On September 14, 2016, CMS notified Petitioner that it imposed a per-day CMP of $10,391 for the one day of immediate jeopardy and substandard quality of care on March 27, 2015, based on the deficiency cited under 42 C.F.R. § 483.25(h), Tag F323.  CMS Ex. 1 at 1-2.  Although Petitioner did not have a NATCEP, CMS also imposed a prohibition on the approval of a NATCEP for two years, effective March 27, 2015, through March 26, 2017.  *Id.* at 3.  CMS did not impose any remedies for the deficiency cited under 42 C.F.R. § 483.60(b), (d), and (e), Tag F431.  CMS Ex. 2 at 1-2.

**Page 6**

On November 11, 2016, Petitioner timely requested a hearing to appeal the immediate jeopardy and substandard quality of care findings, imposition of the CMP, and the amount of the CMP.  Docket Entry No. 1 (hereinafter "P. RFH") at 2.  The case was docketed and assigned to ALJ Carolyn Cozad Hughes.  On November 28, 2016, Judge Hughes issued an Acknowledgment and Initial Pre-hearing Order (pre-hearing order) establishing a pre-hearing exchange schedule for the parties.  Docket Entry No. 2.  The pre-hearing order directed the parties to file briefs, proposed exhibits, and written direct testimony for all witnesses they wanted to present in this case.  The pre-hearing order also set forth guidelines for the parties to file a motion for summary judgment.

CMS notified Petitioner on February 1, 2017, that the imposed remedy was changed from a per-day to a per-instance CMP in the amount of $10,391.  CMS Ex. 2.  On February 24, 2017, CMP further notified Petitioner that the amount of the per-instance CMP was changed to $7,550.  CMS Ex. 23.

On February 27, 2017, CMS filed an exchange, including a motion for summary disposition/pre-hearing brief (CMS Br.), a proposed witness list, a proposed exhibit list, and 24 proposed exhibits (CMS Exs. 1-24).  Docket Entry Nos. 4-6x.  On April 3, 2017, Petitioner filed its exchange, including a pre-hearing brief and response in opposition to CMS' motion for summary judgment (P. Br.); a proposed witness list; a proposed exhibit list; and 3 proposed exhibits (P. Exs. 1-3).  Docket Entry Nos. 9-11c.  This case was reassigned to me on July 24, 2019.  Docket Entry No. 12.  CMS' motion for summary judgment is ripe for a ruling.

II.  Jurisdiction

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

III.  Preliminary Matters

Before addressing the merits of this case, I admit the parties' exhibits into the record and address Petitioner's arguments concerning the change of remedy imposed by CMS.

**A. Admission of Exhibits**

CMS filed 24 exhibits in its pre-hearing exchange, identifying them as CMS Exs. 1 through 24.  Petitioner filed three exhibits in its pre-hearing exchange, identified as P. Exs. 1 through 3.  In the absence of any objection from either party, all exhibits are admitted into the record.

**Page 7**

**B. CMS' Change of Enforcement Remedy Does Not Infringe on Petitioner's Appeal Rights**

During the course of this proceeding, CMS changed the enforcement remedy from a $10,391 per-day CMP to a per-instance CMP of the same amount and then reduced the amount of the per-instance CMP to $7,550.  CMS Exs. 1-2, 23.  In its prehearing brief and opposition to CMS' motion for summary judgment, Petitioner argues that CMS cannot change the type of penalty imposed while an appeal is pending in an attempt to foreclose Petitioner's appeal rights.  P. Br. at 15-16.  I reject this argument.  Petitioner does not have a right to appeal CMS' choice of remedy because such action is expressly excluded by the regulations and CMS' choice of remedy is not considered an initial determination.  By extension, Petitioner cannot challenge CMS' decision to change the remedy because it is not appealable in the first instance and cannot be considered a reopened and revised determination.  Additionally, I find no harm or prejudice to Petitioner's appeal rights because Petitioner already appealed the initial determination involving the complaint survey at issue, Petitioner received written notice of the change in remedy, CMS reduced the amount of the CMP, and Petitioner had an opportunity to address the new remedy in this proceeding.  Therefore, as explained in more detail below, I conclude that Petitioner's due process rights were not violated when CMS changed Petitioner's remedy from a $10,391 per-day CMP to a $7,550 per-instance CMP after Petitioner filed a request for hearing.

It is well established that facilities do not have a right to appeal CMS' choice of remedy.  In *Emerald Oaks,* the Board explained that the intended approach of the regulations is "to permit review of the factual underpinnings on which the remedy is based . . . but to make unreviewable the decision to impose a remedy and the choice of that remedy."  *Emerald Oaks,* DAB No. 1800 at 7 (2001).  Indeed, the SNF enforcement regulations expressly state that "[a] facility may not appeal the choice of remedy, including the factors considered by CMS or the State in selecting the remedy . . . ."  42 C.F.R. § 488.408(g)(2); *see also* 42 C.F.R. § 488.438(e)(2) (excluding administrative review of "the exercise of discretion by CMS or the State to impose a civil money penalty").  Consistently, the regulations governing appeal procedures exclude "the determination as to which sanction was imposed" from the definition of an "initial determination" and the scope of review.  42 C.F.R. § 498.3(b)(13); *see also* 42 C.F.R. § 498.3(d)(11) (stating "[a]dministrative actions that are not initial determination[s] (and therefore not subject to appeal . . .)" include "[t]he choice of alternative sanction or remedy to be imposed on a provider or supplier").  Thus, the law is clear that CMS' choice of remedy is not an initial determination that may be appealed.

Since CMS' initial choice of remedy cannot be appealed, it follows that CMS' decision to change that remedy is not subject to review.  Although the regulations permit the reopening and revision of initial determinations, as well as review of such revised determinations, CMS' decision to change an enforcement remedy cannot be considered a

**Page 8**

revised determination because the original remedy imposed by CMS is not itself an initial determination.7
  *See* 42 C.F.R. § 498.30 (permitting CMS to reopen initial determinations, within certain limitations that do not apply in this case); *see also* 42 C.F.R. § 498.20(b)(3) (providing that an initial determination is binding unless revised); *see generally* 42 C.F.R. § 498.32 (explaining the notice requirements and binding effect of revised determinations).

In the written notices changing Petitioner's remedy, CMS acknowledged Petitioner's pending appeal and correctly stated that no further appeal rights existed because CMS' choice of remedy is discretionary and not reviewable.  *See* 42 C.F.R. § 488.408(g).  The notices also explained:

[t]his letter is not an initial determination pursuant to 42 C.F.R. § 498.3(b), nor is it a reopened or revised determination pursuant to 42 C.F.R. § 498.32.

CMS Exs. 2, 23.  Additionally, there is no regulation prohibiting CMS from changing the remedy in these circumstances.  Although section 488.438(d) limits CMS' authority to *increase* a *per-day* CMP under certain circumstances after a hearing has been requested, there is no such restriction for penalty amounts that remain the same or, as in this case, decrease.  Accordingly, I conclude that CMS did not violate the regulations when it changed Petitioner's remedy, and Petitioner may not challenge CMS' decision to change the remedy.

Although Petitioner contends that CMS changed the enforcement remedy in order to limit its appeal rights, Petitioner has not submitted any evidence suggesting an improper motive by CMS.  Moreover, I find that neither the change in remedy nor the timing of such a change, individually or together, is sufficient to establish a due process violation.  CMS has discretion to select an appropriate remedy to correct a facility's noncompliance,

**Page 9**

and CMS may exercise its discretion to change the remedy, where it deems appropriate.  As the Board has recognized in *Britthaven of Goldsboro,* "[c]hanging the remedy imposed can permit CMS flexibility to ensure that it acts consistently in imposing remedies, and appropriately reacts to ongoing facility conduct."  *Britthaven of Goldsboro*, DAB No. 1960 at 6 (2005).  Here, CMS explained that it reduced the amount of the per-instance CMP because it was calculated erroneously based on a new rule that did not apply.  CMS Ex. 23.  CMS did not provide a reason for changing the per-day CMP to a per-instance CMP, but I note that CMS may have decided that a per-instance CMP was more appropriate considering the particular circumstances of this case.  For instance, CMS may have decided that a per-instance CMP was more appropriate because the deficiency lasted less than two days and was corrected during the March 27, 2015 survey.8
  Nevertheless, I cannot review CMS' decision to change the CMP or even speculate about CMS' rationale.  However, on its face, I find no illicit reason that infringes on Petitioner's appeal rights.  Although it might be unusual for CMS to change the type of remedy while an administrative appeal is pending, it has the discretion to do so, and doing so ensures that appropriate remedial measures are taken to achieve facility compliance with Medicare participation requirements and to protect the public health.

While CMS' decision to change Petitioner's remedy may affect the scope of my review,9
 I find no prejudice against Petitioner.  Petitioner had requested a hearing already to review the March 27, 2015 survey determination of noncompliance when it received the notices changing the imposed remedy.  Even though CMS changed the remedy from a per-day to a per-instance CMP, the factual and legal bases for imposing the remedy have not changed.  CMS did not add, alter, or remove any allegations of noncompliance or change the immediate jeopardy and substandard quality of care findings.  Moreover,

**Page 10**

CMS did not impose any additional remedies.  As explained above, the regulations are clear that the facility must appeal the basis for the noncompliance determination and not the choice of remedy.  Accordingly, the issues in this case remain the same, despite the change in remedy, and Petitioner was afforded a full and fair opportunity for a hearing.

Finally, I also note that changing the remedy from a per-day CMP to a per-instance CMP did not affect CMS' authority to collect the CMP in advance and hold it in escrow pending the outcome of independent informal dispute resolution or this proceeding.  42 C.F.R. § 488.431(b)-(d).  Indeed, the February 24, 2017 notice reduced the CMP amount from $10,391 to $7,550 and gave Petitioner instructions on how to obtain a refund of the difference.  CMS Ex. 23 at 2.  Therefore, I reject Petitioner's argument that its appeal rights were infringed upon when CMS changed the imposed remedy after Petitioner requested a hearing on the initial determination.

IV.  Issues

The issues I must decide in this case are:

A. Whether summary judgment is appropriate;

B. Whether Petitioner substantially complied with the Medicare participation requirement at 42 C.F.R. § 483.25(h);

C. Whether CMS' finding of immediate jeopardy is reviewable; and

D. If Petitioner was not in substantial compliance, whether the imposed per-instance CMP amount is reasonable.

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

My conclusions of law are set forth in italics and bold font followed by detailed factual and legal analyses.

**A. Summary Judgment Is Appropriate Because There Are No  Disputed Issues of Material Fact**

Summary judgment is appropriate if there is "no genuine issue as to any material fact, and the moving party is entitled to judgment as a matter of law."  *Mission Hosp. Reg'l Med. Ctr.*, DAB No. 2459 at 5 (2012) (citations omitted).  In order to prevail on a motion for summary judgment, the moving party must show that there is no genuine dispute of material fact requiring an evidentiary hearing and that it is entitled to judgment as a matter of law.  *Id.*  If the moving party meets this initial burden, the non-moving party must "come forward with 'specific facts showing that there is a genuine issue for trial.'"

**Page 11**

*Matsushita Elec. Indus. Co. v. Zenith Radio Corp.*, 475 U.S. 574, 587 (1986).  "To defeat an adequately supported summary judgment motion, the non-moving party may not rely on the denials in its pleadings or briefs, but must furnish evidence of a dispute concerning a material fact – a fact that, if proven, would affect the outcome of the case under governing law."  *Senior Rehab. & Skilled Nursing Ctr.*, DAB No. 2300 at 3 (2010).

In evaluating a motion for summary judgment, an ALJ does not address credibility or evaluate the weight of conflicting evidence.  *Holy Cross Vill. at Notre Dame, Inc.*, DAB No. 2291 at 5 (2009).  Rather, in examining the evidence to determine the appropriateness of summary judgment, an ALJ must draw all reasonable inferences in the light most favorable to the non-moving party.  *See Brightview Care Ctr.*, DAB No. 2132 at 10 (2007) (upholding summary judgment where inferences and views of non-moving party are not reasonable).  "[A]t the summary judgment stage the judge's function is not   . . . to weigh the evidence and determine the truth of the matter but to determine whether there is a genuine issue for trial."  *Anderson v. Liberty Lobby, Inc*., 477 U.S. 242, 255 (1986).  However, drawing factual inferences in the light most favorable to the non-moving party does not require that I accept the non-moving party's legal conclusions.  *Cedar Lake Nursing Home*, DAB No. 2344 at 7 (2010).

Here, the parties do not dispute the basic underlying facts.  Accordingly, there is no genuine issue of material facts concerning whether Petitioner was in substantial compliance with Tag F323, 42 C.F.R. § 483.25(h), on March 27, 2015.  CMS cited Petitioner for failing to prevent accident hazards because Petitioner did not restrict second floor windows from opening to widths that could permit residents to elope or fall, which resulted in widespread immediate jeopardy to residents' health or safety.  Petitioner does not dispute that some windows had window cranks present and were missing screens.  P. Ex. 3 at ¶¶ 17-20.  Although Petitioner notes that only one of the three surveyors used a measuring tape to measure the window openings (*id.* at ¶ 11), it does not dispute the specific measurements taken by any of the surveyors, including the surveyor who used a measuring tape.  Moreover, Petitioner does not dispute that when windows were opened by turning the crank, the window openings were large enough to permit a person to pass through them during an elopement or fall.  *See* CMS Ex. 20 at ¶ 13.

Instead, Petitioner argues that the surveyors were not trained or experienced architects, engineers, or building inspectors, and CMS applied the wrong building code provisions in determining whether it was in compliance with section 483.25(h).  P. Ex. 2 at ¶¶ 15-20, 35, 41; P. Ex. 3 at ¶¶ 5-6.  Petitioner also argues that its windows complied with the correct building code requirements at the time of construction (P. Ex. 2 at ¶¶ 7-13); it had not been cited previously for any deficiencies related to the facility's windows (P. Ex. 2 at ¶¶ 29-34; P. Ex. 3 at ¶ 19); none of the windows were open at the time of the inspection (P. Ex. 3 at ¶¶ 9, 21); the residents are not high-risk for elopement or suicide (P. Ex. 2 at ¶ 6; P. Ex. 3 at ¶ 22); and there was no actual harm or risk of harm presented to residents (P. Ex. 3 at ¶¶ 19-25).

**Page 12**

However, Petitioner's arguments concern facts that are not material to the outcome of this case and legal issues.  Therefore, they are irrelevant to my inquiry into whether summary judgment is appropriate and do not affect the outcome of this case under governing law.  For example, section 483.25(h) does not require the existence of open windows, high-risk residents, or actual harm from an accident for a finding of noncompliance.  Noncompliance exists if the environment has the "potential" to cause more than minimal harm, and it constitutes immediate jeopardy if it is "likely to cause" death or serious harm.  *See* 42 C.F.R. § 488.301 (definitions of "noncompliance," "substantial compliance," and "immediate jeopardy").  Additionally, the basis for Petitioner's noncompliance does not concern Life Safety Code (LSC) requirements or construction standards.  The survey at issue was not an LSC survey and CMS did not make any determinations concerning whether Petitioner complied with LSC requirements.  Rather, the state surveyors conducted a complaint survey and determined that Petitioner was not in substantial compliance with the requirement concerning accident hazards.  As such, the applicable building code provisions and whether the surveyors possessed building code-related experience and qualifications are not relevant.  Even if Petitioner were correct that the survey team should have included building inspectors, engineers, or other building code experts, the lack of such professionals on the survey team does not invalidate the survey or findings of noncompliance.  42 C.F.R. § 488.318(b); *see also Avon Nursing Home*, DAB No. 2830 at 10-12 (2017) (citing the Act, regulations, and well-established case law holding that "allegations of inadequate survey performance are irrelevant to ALJ or Board review of CMS' noncompliance and remedy determinations").

To the extent Petitioner suggests that the windows did not present a foreseeable accident hazard because they complied with applicable building code requirements and the facility did not have any previous accidents or deficiencies related to the windows, I find that argument unpersuasive.  Petitioner concedes that, except for "very few rooms [that] had window cranks present," it had removed window cranks "so that [the windows] could not be opened at will."  P. Ex. 3 at ¶¶ 8, 20.  Petitioner also concedes that "[a] few windows did not have screens . . . ."  *Id.* at ¶ 17.  Finally, Petitioner admits that a resident opened a window in Room 222 at surveyor Theresa Slisz's request, which prompted her to initiate an inspection of all windows.  *Id.* at ¶ 9.  Thus, regardless of its history of compliance with building code requirements and the lack of accidents, Petitioner recognized that opening the windows could present an accident hazard to its residents and that residents were capable of opening the windows without assistance.  Recognizing that risk, Petitioner established a policy and protocol in an attempt to mitigate the risk.  However, Petitioner did not follow its policy and protocol fully and failed to take additional measures, such as installing chains to restrict the window openings, in order to mitigate the risk that it already recognized.  Similarly, it is not material whether the windows were actually open or whether the facility had residents who were high-risk for elopement or suicide at the time of the survey.  Petitioner clearly recognized that the windows were a hazard if "opened at will" and had a duty to mitigate that foreseeable risk of harm to its

**Page 13**

residents.  In short, Petitioner has not raised a genuine issue of material fact concerning its compliance with 42 C.F.R. § 483.25(h).  Rather, Petitioner insists that it cannot be held responsible because CMS applied the wrong building code, which is a legal question appropriate for resolution on summary judgment.  As explained above, the applicable building code is irrelevant to the issues in this case.  Accordingly, I conclude that summary judgment in CMS' favor is appropriate.

**B. Petitioner Failed to Comply Substantially with 42 C.F.R. § 483.25(h) (Tag F323)**

The regulation governing the quality of care provided by long-term care facilities requires facilities to "provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care."  42 C.F.R. § 483.25.  Specifically, section 483.25(h) states:

(h) *Accidents.* The facility must ensure that –

(1) The resident environment remains as free of accident hazards as is possible; and
(2) Each resident receives adequate supervision and assistance devices to prevent accidents.

42 C.F.R. § 483.25(h)(1)-(2).  The Board has stated that "[s]ection 483.25(h)(1) requires that a facility address foreseeable risks of harm from accidents 'by identifying and removing hazards, where possible, or where the hazard is unavoidable because of other resident needs, managing the hazard by reducing the risk of accident to the extent possible.'"  *Meridian Nursing Ctr.,* DAB No. 2265 at 3 (2009) (quoting *Maine Veterans' Home – Scarborough*, DAB No. 1975 at 10 (2005)).  Additionally, "[s]ection 483.25(h)(2) requires that a facility take 'all reasonable steps to ensure that a resident receives supervision and assistance devices that meet his or her assessed needs and mitigate foreseeable risks of harm from accidents.'"  *Id.* (quoting *Briarwood Nursing Ctr.*, DAB No. 2115 at 11 (2007), citing *Woodstock Care Ctr. v. Thompson*, DAB No. 1726 (2000) (facility must take "all reasonable precautions against residents' accidents"), *aff'd, Woodstock Care Ctr. v. Thompson*, 363 F.3d 583 (6th Cir. 2003)).  A facility has discretion on how to achieve compliance, but its "failure to comply with its own policies can support a finding that the facility did not achieve compliance with the regulatory standard."  *Bivins Mem'l Nursing Home,* DAB No. 2771 at 9 (2017); *see also Sheridan Health Care Ctr.*, DAB No. 2178 at 32 (2008); *Liberty Commons Nursing & Rehab – Alamance*, DAB No. 2070 at 3 (2007).

Although Petitioner disputes the finding of noncompliance and substandard quality of care, Petitioner does not dispute the material facts establishing Petitioner's noncompliance with Tag F323, 42 C.F.R. § 483.25(h).  P. Br. at 2, 8.  The facility's

**Page 14**

windows were installed in 1987.  P. Ex. 2 at ¶ 26.  They are Andersen casement windows that require the use of a crank handle to open and close the windows.  P. Ex. 2 at ¶¶ 26-27; CMS Ex. 20 at ¶ 16.  Each resident room has two windows that are side by side with a narrow partition separating them.  CMS Ex. 20 at ¶ 16; *see also* CMS Ex. 13.  The windows are three to four feet in height and located about waist-high above the floor.  CMS Ex. 20 at ¶ 17.  The windows are hinged on one side and the sash opens horizontally on the opposite side of the hinges.  P. Ex. 2 at ¶ 26; P. Ex. 3 at ¶ 15.  The windows also have a lock on the opposite side of the hinges.  *Id.*  The second floor windows were at least ten feet above the ground outside.  CMS Ex. 20 at ¶ 17.

The state agency conducted a two-day complaint survey at Petitioner's facility on March 26 and 27, 2015.  P. Ex. 3 at ¶ 4; *see also* CMS Exs. 8, 9.  One of the complaints received by the state agency was that the windows in the residents' rooms could not be opened.  CMS Ex. 20 at ¶ 11.  Thus, the surveyors asked residents whether the windows can be opened and how wide.  CMS Ex. 9 at 1 ("Resident Interview Questions" on Slisz's Surveyor Notes Worksheet).  Additional questions included whether window locks were removed, and, if so, when and why they were removed.  *Id.* On the second day of the survey, Ms. Slisz asked Petitioner's Assistant Administrator, John Cofrancesco, about the windows at the facility.10
  CMS Ex. 20 at ¶ 11; P. Ex. 3 at ¶ 8.  Mr. Cofrancesco explained that:

Generally, the window cranks in the facility were removed so that they could not be opened at will.  The maintenance department holds the cranks and opens windows upon request.

P. Ex. 3 at ¶ 8; *see also* CMS Ex. 20 at ¶ 11; CMS Ex. 9 at 7.  According to Ms. Slisz, "Mr. Cofrancesco [also] stated that windows opened to approximately one foot, but that windows are only opened by maintenance."  CMS Ex. 20 at ¶ 11.

Ms. Slisz and two other surveyors, Beth Ware and Kimberly Strong, inspected the facility's second floor windows and measured the depth of the window openings.  P. Ex. 3 at ¶ 11; CMS Ex. 20 at ¶¶ 15, 19-20.  Only one of the three surveyors (Ms. Slisz) used a tape measure to measure the window openings.  P. Ex. 3 at ¶ 11; CMS Ex. 20 at ¶¶ 8, 15.  The other two surveyors measured the window openings "using their arms like makeshift rulers."  P. Ex. 3 at ¶ 11; *see also* CMS Ex. 20 at ¶¶ 21-22.  Mr. Cofrancesco accompanied Ms. Slisz while she measured the window openings using a tape measure.  P. Ex. 3 at ¶ 12; CMS Ex. 20 at ¶ 15.  Ms. Slisz inspected the windows in resident rooms numbered 211 through 224, 226, and 228.  CMS Ex. 9 at 13-14.  She also inspected the windows in one of the resident lounges/day rooms.  *Id.* at 14; CMS Ex. 20 at ¶ 23.  Ms.

**Page 15**

Ware inspected the windows in resident rooms 201 through 210, and Ms. Strong inspected the windows in resident rooms 225, 227, and 229 through 234, and the other resident lounge/day room.  CMS Ex. 10 at 4-5; CMS Ex. 11 at 3; CMS Ex. 20 at ¶ 20.

In total, the surveyors inspected 72 windows, including 68 resident windows and 4 windows in the resident lounges/day rooms.  Most of the windows had cranks to open the windows.  CMS Ex. 20 at ¶ 35.  I note that each surveyor testified similarly that she could not have opened and measured the windows unless the cranks were present during their window inspections.  *Id*. at ¶ 15; CMS Ex. 21 at ¶ 12; CMS Ex. 22 at ¶ 10.  Petitioner has not specifically disputed which windows had cranks present or the surveyors' testimonies about not being able to open the windows unless cranks were present on all of the windows that opened.  However, Petitioner stated that "very few rooms had window cranks present."  P. Br. at 8; P. Ex. 3 at ¶ 20.  Each surveyor documented whether the windows included track bars and screens, whether the windows could be opened, and the size of window openings.

Ms. Slisz inspected 34 windows, of which 7 were missing track bars and 9 were missing screens.  CMS Ex. 9 at 13-14.  According to her notes, 30 windows opened to 18 inches or further in depth.  *Id.* Notably, 13 windows opened to 28 inches and 7 windows opened to 29 inches.  *Id.* One of the windows in the east wing resident lounge/day room opened to 23.5 inches.  *Id*.  Ms. Ware inspected 20 windows, of which 14 opened further than 23 inches, and one was missing a screen.  CMS Ex. 10 at 4-5.  Ms. Strong inspected 20 windows,11
 of which 14 opened to 26 inches.  CMS Ex. 11 at 3-4.  Additionally, one of the windows was missing a track bar.  *Id.* at 3.  The Resident Roster on which Ms. Strong documented her findings indicates that the second floor census was either 58 or 59, with a total capacity of 64 beds.  *Id.* at 2-4 (indicating that room 201 was occupied on March 26, 2015, but was vacant on March 27, 2015).

On the Resident Roster, Ms. Slisz placed the number "1" next to residents who were "confused," the number "2" next to residents identified as "wanderers," the number "3" next to residents who were an "elopement risk," and the number "4" next to a resident who was "self-injurious."  CMS Ex. 11 at 2; *see* CMS Ex. 20 at ¶ 27.  Ms. Slisz documented that the unit manager identified 24 residents who were confused,12
 which

**Page 16**

meant they scored 0-7 on the Brief Interview for Mental Status (BIMS), indicating severely impaired cognition.  *Id.* at 2; *see* CMS Ex. 20 at ¶ 27; CMS Ex. 3 at 5.  The unit manager also identified four residents who were elopement risks13
 and four residents who had three issues, *i.e.*, were confused, wanderers, and elopement risks, but none of them were ambulatory.  CMS Ex. 11 at 2; *see* CMS Ex. 20 at ¶¶ 27-28 (Ms. Slisz placed the letter "A" next to ambulatory residents, meaning "the resident was able to ambulate completely independently, without the use of assistive devices, such as a cane, walker, or wheelchair.").  However, one resident in room 220 was confused and self-injurious.  CMS Ex. 11 at 2.  Finally, Ms. Slisz indicated that 9 residents on the second floor were ambulatory.  CMS Ex. 11 at 2.

Although Petitioner notes that two of the surveyors did not use measuring tapes to measure the window openings, Petitioner does not dispute that cranks were left on windows, permitting them to open without supervision, or the actual measurements of the window openings alleged by CMS.  Likewise, Petitioner does not dispute that window screens or track bars, which could provide further elopement protections, were missing.  Petitioner also does not dispute that 9 residents on the second floor were ambulatory.  Importantly, Petitioner does not dispute that a resident sitting near an unopened window was able to open the window "at will," in direct contravention of its own policy.  *See* P. Ex. 3 at ¶ 9.  Petitioner appears to question the surveyor's motives in asking the resident to open the window, suggesting that it may have been impermissible.  P. Br. at 8.  However, Petitioner does not dispute that "[o]ne of the complaints received by the [state agency] was that windows in the resident rooms were not able to be opened."  CMS Ex. 20 at ¶ 11.  Further, it is well-established that surveyors are not limited to the subject matter of the complaint when conducting a complaint survey.  Indeed, they may investigate and cite other potential deficiencies.  *See, e.g.*, 42 C.F.R. § 488.30 (defining "substantiated complaint survey" as "a complaint survey that results in the proof or finding of noncompliance at the time of the survey . . . whether or not the cited deficiency was the original subject of the complaint.").

I accept for summary judgment purposes that Petitioner complied with applicable building code requirements, and the facility did not have any previous accidents or deficiencies related to the windows.  P. Ex. 2 at ¶¶ 7-20, 29-30, 34, 37, 41; P. Ex. 3 at ¶¶ 18-19, 25; *see also* P. Br. at 3-5, 6, 8, 15, 17-19; CMS Ex. 18 at 23-61.  Nevertheless, Petitioner's compliance history and lack of previous accidents do not absolve it from responsibility.  As a legal matter, they do not preclude me from concluding that Petitioner was not in substantial compliance with Medicare program participation requirements on

**Page 17**

March 27, 2015.  A finding of noncompliance with section 483.25(h) does not depend on whether an accident actually occurred or the facility's compliance history.  Rather, the focus is on whether the facility took all reasonable steps to mitigate foreseeable risk of harm from accidents:

For a risk to be foreseeable, it need not have been made obvious by having already materialized.  The regulation speaks in terms of ensuring that what is "practicable" and "possible" to do is done.  What is thus required of facilities is not prescience but reason and professional judgment in assessing what can be done to make residents (given their special needs) safe, through removing accident hazards, providing appropriate devices, and ensuring adequate supervision.

*Josephine Sunset Home*, DAB No. 1908 at 14-15 (2004).  Thus, a facility must anticipate possible accidents and take reasonable steps to prevent them.  Here, Petitioner clearly anticipated possible accidents related to the window openings and attempted to abate that hazard by establishing a policy of removing the window cranks and having the maintenance department open windows only upon request.  Although facilities have some flexibility in choosing methods to prevent accidents, those methods must ensure that the facility remains as free of accident hazards as possible and must constitute an adequate level of supervision.  Yet, Petitioner did not follow its own mitigation policy and protocol.  As a result, numerous windows were able to be opened to unsafe depths.  Thus, Petitioner's policy and protocol for mitigating the known window hazards was ineffective.

As already noted, a SNF's regulatory violations must pose a risk for more than minimal harm to justify the imposition of enforcement remedies.  42 U.S.C. § 1395i-3(h)(2); 42 C.F.R. §§ 488.301, 488.402(b).  Viewing the undisputed facts in the light most favorable to Petitioner and disregarding the window measurements from Ms. Strong and Ms. Ware because they did not use measuring tapes, Ms. Slisz still measured 30 windows that opened to 18 inches or wider.  CMS Ex. 9 at 13-14.  Petitioner does not dispute Ms. Slisz's measurements.  Moreover, Petitioner does not dispute that one resident in each of rooms 206, 209, 210, 216, 218, 229, and 234 was ambulatory, and both residents in room 217 were ambulatory.  CMS Ex. 11 at 2.  Again, disregarding the windows measured by Ms. Ware and Ms. Strong, four out of the nine ambulatory patients were in rooms with windows that opened to 23 inches or wider.  *Compare* CMS Ex. 11 at 2 *and* CMS Ex. 9 at 13-14.  Specifically, Ms. Slisz measured that one window in room 216 opened to 24 inches and the other window in room 216 opened to 29 inches.  CMS Ex. 9 at 13.  Additionally, the window that opened to 29 inches did not have a screen or track bar.  *Id.* According to Ms. Slisz's notes, both windows in room 217 opened to 28 inches, and both were missing screens and track bars.  *Id.* Ms. Slisz also measured that one window in room 218 opened to 23 inches, but the screen and track bar were present, whereas the other window opened to 28 inches and had a screen.  *Id.* She did not note whether the

**Page 18**

window that opened to 28 inches included a track bar.  *Id.*  However, she specifically noted that the window crank was present.  *Id.* Ms. Slisz measured the window openings in rooms 222 and 223 to be 28 inches.  *Id.* at 14.  The crank was on the window in room 222, and the windows were missing track bars and screens.  *Id.* Ms. Slisz noted that the resident was in room 222 at the time of her inspection.  *Id.* Track bars were present on both windows in room 223, but one window was missing a screen.  *Id.*  Track bars and screens were present on the windows in room 224, but the window opened to 24 inches.  *Id.*  Similarly, track bars and screens were present on the windows in room 226, but one window opened to 22 inches.  *Id.*  Ms. Slisz noted that the track bars and screens were present on the windows in room 228, but one window opened to 18 inches, and the other window opened to 24 inches.  *Id.* Finally, Ms. Slisz noted that one of the windows in the east wing resident lounge/day room measured 28.5 inches, which was accessible to all ambulatory residents.  *Id.*

The undisputed facts establish that 30 windows on the second floor of Petitioner's facility opened to widths that could permit residents to elope or fall, including windows in rooms of ambulatory residents and in the common areas accessible to ambulatory residents.  The windows are located at least 10 feet above the ground.  CMS Ex. 20 at ¶ 17.  As such, the windows posed a risk for more than minimal harm to residents.  Moreover, the undisputed facts show that Petitioner failed to follow its own protocol of removing window cranks.  Petitioner failed to provide adequate supervision and to take adequate steps to mitigate the foreseeable risk presented by the second floor windows.  Accordingly, I conclude that Petitioner was not in substantial compliance with Tag F323, 42 C.F.R. § 483.25(h).

Petitioner asserts that it was in substantial compliance because its residents are not high-risk for elopement or suicide or in need of a lock-down unit.  P. Ex. 2 at ¶ 6; P. Ex. 3 at ¶ 22.  Petitioner also asserts that the windows did not present any actual harm or risk of harm to its residents.  P. Ex. 3 at ¶ 19-22, 25.  I disagree.  Although I must view the undisputed facts in the light most favorable to Petitioner before granting summary judgment to CMS, I am only required to draw *reasonable* inferences in Petitioner's favor.  *See Brightview*, DAB No. 2132 at 10.  Petitioner admitted that "[t]ypical residents may suffer from age-related cognitive deficits[,]" and did not dispute that nine residents were ambulatory.  P. Ex. 2 at ¶ 6; CMS Ex. 11 at 2.  Regardless of whether the residents were high-risk for elopement or suicide, the second floor windows were not all secured to prevent accidental falls.  Cranks were left on windows, in violation of Petitioner's own policy, and 30 windows opened wide enough – 18 to 29 inches – for residents to fall through them unintentionally.  Additionally, screens and track bars were missing from several windows.  These conditions presented a risk for more than minimal harm to Petitioner's residents.  Petitioner contends that a resident would have to "climb up to the window, and attempt to climb out[,]" in order to elope, but that is not necessarily true.  P. Br. at 9.  Petitioner does not dispute that the windows on the second floor are waist-high.  CMS Ex. 20 at ¶ 17.  Any resident could lean or lose his or her balance and fall out the

**Page 19**

windows.  A resident who is high-risk for elopement or suicide intentionally climbing out of the windows is not the only scenario that presents an accident hazard.  *See* SOM, app. PP, Guidance to Surveyors for Long Term Care Facilities, F323, § 483.25(h), Accidents (Rev. 27, effective August 17, 2007) (defining "accident" as "any unexpected or unintentional incident, which may result in injury or illness to a resident.").  Moreover, as the Board has explained, "[f]or a risk to be foreseeable, it need not have been made obvious by having already materialized."  *Josephine Sunset Home*, DAB No. 1908 at 14.  For this reason, I find the decisions cited by Petitioner to be inapposite.  P. Br. at 12-15.  Because the unsecured windows had the potential to cause more than minimal harm to Petitioner's residents, I further conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(h).

**C. In this Case, CMS' Finding that Petitioner's Noncompliance Posed Immediate Jeopardy to Resident Health and Safety Is Not Reviewable**

Petitioner has challenged CMS' finding that the deficiency cited under 42 C.F.R. § 483.25(h) placed its residents in immediate jeopardy.  P. RFH at 1; P. Br. at 16-18.  Specifically, Petitioner argues that CMS' immediate jeopardy finding is a factual dispute, which Petitioner contends is "clearly erroneous" because CMS has not established that serious injury, harm, impairment, or death was likely from Petitioner's noncompliance with Medicare program participation requirements.  P. Br. at 16-18.  Petitioner also argues that the immediate jeopardy finding is clearly erroneous considering the facility's long history of compliance and the fact that it is not a psychiatric facility that admits suicidal patients or patients requiring intense supervision in a lock-down unit.  *Id.* at 17-18.  Instead, Petitioner contends that its residents were not at any risk from the windows, and "CMS should have considered a less severe designation, recognizing that there was no actual harm."  *Id.* at 18.  However, CMS has imposed only a per-instance CMP in this case.  Consequently, I have no authority to review CMS' finding of immediate jeopardy.

An ALJ may review CMS' scope and severity findings (which includes a finding of immediate jeopardy) only if a successful challenge would affect:  (1) the range of the CMP amounts that CMS could collect; or (2) a finding of substandard quality of care that results in the loss of approval of a facility's NATCEP.  42 C.F.R. § 498.3(b)(14); 42 C.F.R. § 498.3(d)(10)(i)-(ii).  Petitioner argues that it should be allowed to challenge CMS' finding of immediate jeopardy because CMS impermissibly changed the penalty from a per-day CMP to a per-instance CMP in order to deny Petitioner its substantive appeal rights.  P. Br. at 15-16.  If CMS had kept the original per-day CMP in place, the immediate jeopardy finding would have been reviewable because the level of noncompliance would have affected the range of CMP amounts that CMS could collect.  42 C.F.R. § 498.3(b)(14)(i); *see also* 42 C.F.R. § 488.438(a)(1).  As discussed above, CMS has the authority to change the enforcement remedy, and CMS' change of remedy in this case did not infringe upon Petitioner's appeal rights.  *See* *supra* Part III.B.

**Page 20**

Contrary to Petitioner's assertion, CMS' initial imposition of a per-day CMP does not make the immediate jeopardy determination reviewable in this case.  P. Br. at 19.  CMS ultimately imposed a per-instance CMP against Petitioner.  Unlike per-day CMPs, the regulations provide a single range for a per-instance CMP, which is $1,000 to $10,000, and this range applies to both immediate jeopardy and non-immediate jeopardy level noncompliance.  *Compare* 42 C.F.R. § 488.438(a)(1) *with* 42 C.F.R. § 488.438(a)(2).  Thus, although the severity of noncompliance affects the review of the *amount* of a CMP, it does not, in the case of a per-instance CMP, affect the *range* of the CMP.  42 C.F.R. §§ 488.438(e) and (f), 488.404.  Accordingly, a successful challenge to the immediate jeopardy finding "has no effect on [CMS'] recovery for the program" because CMS only imposed a per-instance CMP against Petitioner.  P. Br. at 16; *see NMS Healthcare of Hagerstown,* DAB No. 2603 at 6-7 (2014).  Additionally, Petitioner did not have a NATCEP at the time of the survey.  Therefore, Petitioner's challenge to CMS' finding of immediate jeopardy is not subject to review in this case.

**D. A Per-Instance CMP of $7,550 Is Reasonable**

If a facility is not in substantial compliance with Medicare program participation requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, including a CMP.  When determining whether the CMP imposed against Petitioner is reasonable, I consider the factors listed in 42 C.F.R. § 488.438(f):  (1) the facility's history of noncompliance; (2) the facility's financial condition; (3) the factors specified at 42 C.F.R. § 488.404; and (4) the facility's degree of culpability, which includes, but is not limited to, neglect, indifference, or disregard for resident care, comfort, or safety.  The absence of culpability is not a mitigating factor.  42 C.F.R. § 488.438(f)(4).  The factors listed at 42 C.F.R. § 488.404 include:  (1) the seriousness of the deficiency, including its severity and scope; (2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and (3) the facility's prior history of noncompliance in general and specifically with reference to the cited deficiencies.  However, I may not (1) set the CMP at zero or reduce it to zero; (2) review the exercise of discretion by CMS in choosing to impose a CMP; and (3) consider any factors other than those specified in 42 C.F.R. § 488.438(f).  42 C.F.R. § 488.438(e).  Unless a facility contends that a particular regulatory factor does not support the CMP amount, the ALJ must sustain it.  *Coquina Ctr.*, DAB No. 1860 at 32 (2002).

I review the reasonableness of the CMP *de* *novo* and based upon the evidence in the record before me.  *Fireside Lodge Retirement Ctr., Inc.*, DAB No. 2794 at 19 (2017).  I am neither bound to defer to CMS' factual assertions, nor free to make a wholly independent choice of remedies without regard for CMS' discretion.  *See, e.g., Barn Hill Care Ctr.*, DAB No. 1848 at 21 (2002).  Rather, I consider whether the evidence supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found, and in light

**Page 21**

of the above factors.  I also must determine whether the amount of any CMP imposed is within reasonable bounds considering the purpose of the Act and regulations.  *Emerald Oaks,* DAB No. 1800 at 10 (2001); *CarePlex of Silver Spring*, DAB No. 1683 at 14-16 (1999); *Capitol Hill Cmty. Rehab. & Specialty Care Ctr.*, DAB No. 1629 (1997).

In this case, CMS imposed a $7,550 per-instance CMP, which is less than the maximum per-instance CMP that CMS may impose ($10,000).  42 C.F.R. § 488.438(a)(2).  Petitioner argues that the imposed CMP is unreasonable, due in part, to the lack of immediate jeopardy.  P. RFH at 2.  I reject this argument for the reasons explained above.  Under the regulations, Petitioner may not challenge CMS' immediate jeopardy finding in this case, and I may not review it.  *See* *supra* Part III.C.  Petitioner also contends that the $7,550 per-instance CMP "is unreasonable given that the [Petitioner] had no history of noncompliance."  P. Br. at 19.  Petitioner asserts "the exact windows at issue were found to be compliant for nearly 30 years at the time of the survey[,]" and Petitioner "fully remediated the concern within hours of CMS identifying the windows as a potential hazard."  *Id.*; *see also* P. RFH at 2.  For summary judgment purposes, I accept that Petitioner had no history of noncompliance with respect to the windows at issue, any "issue regarding quality of life or quality of care[,]" or violating any Medicare program participation requirements at the immediate jeopardy level.  P. Ex. 2 at ¶ 31.  I also accept that Petitioner fully remediated the windows almost immediately.

Nevertheless, Petitioner's noncompliance in this case was serious and widespread.  Petitioner failed to follow its own policy of removing window cranks from the second floor windows.  Petitioner does not dispute that window cranks were left on the second floor windows and at least 30 second-floor windows opened wider than 18 inches.  Moreover, many of these windows did not have safety screens or track bars.  CMS found that this noncompliance constituted widespread immediate jeopardy to the health and safety of Petitioner's residents, citing the most serious scope and severity level ("L").  *See* 42 C.F.R. § 488.404(b).  As discussed above, I cannot review that immediate jeopardy finding.  *See* *supra* Part III.C.

As noted previously, the per-instance CMP imposed in this case falls below the maximum amount allowed by regulation.  As such, I find that it accounts for Petitioner's lack of noncompliance history.  Although commendable, Petitioner's prompt remediation of the noncompliance is not a factor that I am authorized to consider unless Petitioner satisfied certain requirements, which are not applicable here (i.e., it self-reported and corrected the noncompliance, the noncompliance did not constitute immediate jeopardy, and Petitioner waived its right to a hearing, among other requirements).  *See* 42 C.F.R. § 488.438(c)(2); *see also* 42 C.F.R. §§ 488.438(e)-(f), 488.404.  To the extent that prompt remediation of the noncompliance reflects Petitioner's degree of culpability, I also find that the imposed CMP, which is lower than the maximum CMP permitted by law, already accounts for this factor.  42 C.F.R. § 488.438(f)(4).  Finally, Petitioner has not argued that its financial condition precludes payment of the CMP.  Therefore, based on the

**Page 22**

factors listed in 42 C.F.R. §§ 488.438(f) and 488.404, I conclude that the $7,550 per-instance CMP is reasonable.

VI.  Conclusion

For all the reasons discussed above, I grant CMS' motion for summary judgment, affirm CMS' initial determination that Petitioner failed to comply with 42 C.F.R. § 483.25(h), affirm CMS' determination that the noncompliance constituted immediate jeopardy to Petitioner's residents, and sustain the imposition of the $7,550 per-instance CMP.


          /s/
        Karen R. Robinson

                      Administrative Law Judge
      1. CMS recently revised its regulations to clarify regulatory requirements for the composition of survey teams investigating complaints.  82 Fed. Reg. 36,530, 36,623-25 (Aug. 4, 2017). back to note 1
                      2. CMS recently increased the per-day and per-instance CMP amounts to account for inflation in compliance with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, 104 Pub. L. No. 114-74, 129 Stat. 584, 599.  The new adjusted amounts apply to CMPs assessed after August 1, 2016, for deficiencies occurring on or after November 2, 2015.  See 81 Fed. Reg. 61,538, 61,563 (Sept. 6, 2016).  As the deficiencies alleged in this case occurred prior to November 2, 2015, the increased CMP amounts do not apply in this case. back to note 2
                      3. In its brief, CMS, citing Forms CMS-671 completed by Petitioner, notes that Petitioner did not have a NATCEP at the time of the March 27, 2015 survey.  CMS Br. at 16; see CMS Ex. 6 at 1, CMS Ex. 7 at 1. back to note 3
                      4. "Substandard quality of care" exists when there is a deficiency concerning participation requirements under section 483.13, Resident behavior and facility practices; section 483.15, Quality of life; or section 483.25, Quality of care, which constitutes:  immediate jeopardy (scope and severity levels "J," "K," or "L"); a pattern of or widespread actual harm that is not immediate jeopardy (scope and severity levels "H" and "I," respectively); or a widespread potential for more than minimal harm, but less than immediate jeopardy, with no actual harm (scope and severity level "F").  42 C.F.R. § 488.301. back to note 4
                      5. Effective November 28, 2016, CMS revised the long-term care regulations at 42 C.F.R. pt. 483.  Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities, 81 Fed. Reg. 68,688 (Oct. 4, 2016).  Although the substantive participation requirements relating to accidents, supervision, and devices remained the same, it was renumbered as 42 C.F.R. § 483.25(d).  However, the survey at issue in this case occurred before these changes took effect. back to note 5
                      6. Similarly, when the long-term care regulations were revised, these particular participation requirements pertaining to pharmacy services were renumbered as 42 C.F.R. § 483.45(b), (g), and (h), but the substantive requirements remained the same.  42 C.F.R. pt 483; 81 Fed. Reg. 68,688 (Oct. 4, 2016). back to note 6
                      7. Even if CMS' decision to change the remedy were considered an appealable revised determination, I find no prejudice to Petitioner's hearing rights.  On its own initiative, CMS may reopen and revise an initial determination within 12 months of the initial determination, and CMS acted within the 12-month timeframe in this case.  See 42 C.F.R. § 498.30 (permitting CMS to reopen initial determinations concerning a SNF's noncompliance with Medicare participation requirements within 12 months); see also CMS Ex. 1 (September 14, 2016 initial determination); CMS Ex. 2 (February 1, 2017 notice); CMS Ex. 23 (February 24, 2017 notice).  Furthermore, Petitioner already had appealed the initial determination, and the notices changing the remedy did not present any new issues.  Thus, Petitioner exercised its appeal rights and had a full and fair opportunity to address the new remedy in its pre-hearing exchange (and also would have had such opportunity at a hearing, if one were necessary). back to note 7
                      8. See CMS Center for Clinical Standards and Quality/Survey & Certification Group, Division of Nursing Homes, CMP Analytic Tool User's Guide, Version 1.0, at 21 (effective December 19, 2014), https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-15-16.pdf (stating that a per-day CMP is generally used when the noncompliance lasts for two or more days). back to note 8
                      9. I may review CMS' finding of noncompliance that is the basis for imposing the CMP.  However, I do not have authority to review a facility's level of noncompliance, including an immediate jeopardy determination, unless it changes the range of the CMP amounts or results in the loss of the facility's NATCEP.  42 C.F.R. §§ 498.3(b)(13), (b)(14); 42 C.F.R. § 498.3(d)(10)(i)-(ii).  Although Petitioner's successful challenge of an immediate jeopardy determination would lower the range of a per-day CMP (had one been imposed), the range for a per-instance CMP would not change if the immediate jeopardy finding were not upheld because there is only a single range for a per-instance CMP.  Compare 42 C.F.R. § 488.438(a)(1)(i)-(ii) and (a)(2).  Additionally, Petitioner did not have a NATCEP at the time of the March 27, 2015 survey.  See infra Part IV.2. back to note 9
                      10. As the Assistant Administrator, Mr. Cofrancesco "oversaw the day to day maintenance activities of [Petitioner's facility]."  P. Ex. 3 at ¶ 2.  Mr. Cofrancesco was promoted to Administrator in May 2015, after the March 26 and 27, 2015 survey at issue.  Id. at ¶ 3. back to note 10
                      11. Ms. Strong and Ms. Slisz inspected the windows in the east wing resident lounge/day room together.  Both surveyors noted that one of the windows was screwed shut and could not open.  CMS Ex. 9 at 14; CMS Ex. 11 at 3; CMS Ex. 20 at ¶ 23; CMS Ex. 22 at ¶ 11.  Ms. Slisz measured the other window with a measuring tape, which opened to 23.5 inches.  CMS Ex. 9 at 14; CMS Ex. 20 at ¶ 23. back to note 11
                      12. The SOD and Resident Roster indicate that 23 residents were confused, whereas Ms. Slisz's declaration states that she previously miscalculated the number, and 24 residents were actually confused.  CMS Ex. 3 at 5; CMS Ex. 11 at 2; CMS Ex. 20 at ¶ 28. back to note 12
                      13. Similarly, Ms. Slisz's declaration states that she miscalculated the number of residents who were elopement risks, testifying that there were four residents instead of three residents, as stated on the SOD and Resident Roster.  CMS Ex. 3 at 5; CMS Ex. 11 at 2; CMS Ex. 20 at ¶ 28. back to note 13 Back to top
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