Logan Healthcare Leasing, LLC d/b/a Logan Care and Rehabilitation, DAB CR5677 (2020)

DECISION

The Centers for Medicare & Medicaid Services (CMS) moves for summary judgment, alleging that, based on a smoking accident involving a resident, Logan Healthcare Leasing, LLC d/b/a Logan Care and Rehabilitation (Petitioner or facility) was not in substantial compliance with the Medicare participation requirements at 42 C.F.R. § 483.25(d)(1)-(2) and that the per-instance civil money penalty (CMP) imposed for the substantial noncompliance is reasonable in amount.  Petitioner contests these allegations and opposes CMS’s motion.

As explained below, I conclude that summary judgment is appropriate in this case because the evidence, even viewed in the light most favorable to Petitioner, establishes that:  (1) Petitioner did not substantially comply with the Medicare participation requirements at 42 C.F.R. § 483.25(d)(1)-(2); and (2) the per‑instance CMP imposed is reasonable.  I therefore grant CMS’s motion for summary judgment.

I.       Background and Procedural History

Petitioner is a skilled nursing facility (SNF) located in Logan, Ohio.  CMS Exhibit (Ex.) 15 at 1.  The Ohio Department of Health (state agency) completed a complaint survey on

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January 30, 2018, and found that Petitioner’s facility was not in substantial compliance with two Medicare participation requirements, including one deficiency that was cited at the immediate jeopardy level:

• 42 C.F.R. § 483.25(d)(1)-(2) (Tag F689–Free of Accident Hazards/Supervision/Devices) at scope and severity level J (instance of noncompliance that poses immediate jeopardy to resident health and safety);
• 42 C.F.R. § 483.90(i)(4) (Tag F925–Maintains Effective Pest Control Program) at scope and severity level F (widespread noncompliance that causes no actual harm with the potential for more than minimal harm that is not immediate jeopardy);

CMS Exs. 9, 15.  In a letter dated July 30, 2018, CMS informed Petitioner that it was imposing a $20,905 per-instance CMP for the facility’s noncompliance with Tag F689.  CMS Ex. 9at 2-3.  The state agency had previously notified Petitioner of additional remedies, including termination of Petitioner’s Medicare and Medicaid Agreement and a denial of payment for new admissions.  CMS Ex. 2 at 2.  But, after a revisit survey, CMS found that Petitioner corrected the deficiencies as of March 30, 2018; therefore, those remedies did not go into effect.  CMS Ex. 9 at 2.1

Petitioner timely requested a hearing, and the case was assigned to me.  On October 5, 2018, I issued an acknowledgment and prehearing order (Prehearing Order) establishing a briefing schedule.  In accordance with the briefing schedule, CMS filed a prehearing exchange, including a combined prehearing brief and motion for summary judgment (CMS Br.); exhibit and witness lists; and 40 proposed exhibits (CMS Exs. 1-40).  Petitioner also filed its prehearing exchange, including a combined opposition to CMS’s motion for summary judgment, cross-motion for partial summary judgment, and prehearing brief (P. Br.); exhibit and witness lists; and 10 proposed exhibits (P. Exs. 1‑10).  CMS then responded to Petitioner’s cross-motion for summary judgment.  (CMS Response).

CMS objects to a number of Petitioner’s proposed exhibits and to all of Petitioner’s proposed witnesses (CMS Obj.).  Petitioner did not respond to CMS’s objections.  

CMS objects to P. Ex. 5, the written declaration for one of the facility’s nurses, Janet “Bea” Meade, LPN, arguing that the exhibit was filed out of time without good cause.  CMS Obj. at 1.  I agree that the exhibit was filed untimely.  Further, Petitioner did not

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respond with a showing of good cause.  I therefore sustain CMS’s objection and exclude P. Ex. 5.

CMS also objects to all seven of Petitioner’s witnesses on the basis that Petitioner failed to submit as a proposed exhibit the complete, written direct testimony of each proposed witness, as required by the Prehearing Order.  CMS Obj. at 3-4.  CMS is correct that Petitioner did not file written declarations for its proposed witnesses with its exchange; instead, Petitioner had attached affidavits for its proposed witnesses to its hearing request.  Despite its objection, CMS marked the affidavits as exhibits and submitted them as part of its own exchange.  CMS Ex. 10 at 44-45 (Sarah Secrest), 46-48 (Amy Wilson), 49-50 (Cherokee Hampshire), 51 (John Evans), 52-53 (Jonathan Tucker),2 54-55 (Nicole Thompson), 56-57 (Janet Meade).  Moreover, my Prehearing Order specifically directed Petitioner “NOT to file as proposed exhibits any document[] that CMS has already filed among its proposed exhibits” and “not [to] submit duplicate copies of CMS form 2567, resident treatment records, or any other document that CMS has already filed as one of its proposed exhibits.”  Prehearing Order at 4 (¶ 4).  Assuming Petitioner intended to rely on the same affidavits that were submitted with its hearing request and that were later included as part of CMS’s exchange, I am unable to find that Petitioner contravened the order by failing to file another copy of the affidavits for its witnesses.  I therefore overrule CMS’s objection to Petitioner’s witnesses.

Finally, CMS also objects to P. Exs. 9 and 10 and the affidavit for Jonathan Tucker, Maintenance Manager, on grounds of relevance.  CMS Obj. at 2-3.  The exhibits are related to CMS’s citation of Tag F925 for bed bugs and the facility’s pest control program.  CMS contends that Petitioner has no right to dispute Tag F925 in this forum.  CMS Obj. at 2-3.  As I explain in more detail in section IV.B.3, infra, I agree that Petitioner has no right to a hearing to dispute the Tag F925 deficiency.  Accordingly, I sustain CMS’s objection to P. Exs. 9-10 and also exclude Mr. Tucker as a witness. 

After excluding P. Exs. 5, 9, and 10, I admit P. Exs. 1-4 and 6-8 into the record.  Petitioner has not objected to CMS’s exhibits, and so I admit CMS Exs. 1-40 into the record (including a corrected CMS Ex. 1).

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II.      Issues

The issues in this case are:

1. Whether summary judgment is appropriate;

2. Whether Petitioner failed to comply substantially with Medicare participation requirements; and

3. If Petitioner did not comply substantially with Medicare participation requirements, whether the remedy imposed is reasonable.

III.    Jurisdiction

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

IV.    Discussion

A.    Statutory and Regulatory Framework

The Social Security Act sets requirements for SNF participation in the Medicare program.  The Act authorizes the Secretary of the U.S. Department of Health & Human Services (Secretary) to promulgate regulations implementing those statutory provisions.  Act § 1819 (42 U.S.C. § 1395i-3).  The Secretary’s regulations are found at 42 C.F.R. parts 483 and 488.

A facility must maintain substantial compliance with program requirements in order to participate in Medicare.  To be in substantial compliance, a facility’s deficiencies may pose no greater risk to resident health and safety than “the potential for causing minimal harm.”  42 C.F.R. § 488.301.  A deficiency is a violation of a participation requirement established by sections 1819(b), (c), and (d) of the Act (42 U.S.C. § 1395i-3(b), (c), and (d)) or the Secretary’s regulations at 42 C.F.R. pt. 483, subpt. B.  Id.  “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 the participation requirements.  Act § 1864(a) (42 U.S.C. § 1395aa(a)); 42 C.F.R. §§ 488.10, 488.20.  The Act and regulations require that facilities be surveyed on average every twelve months, and more often if necessary, to ensure that identified deficiencies are corrected.  Act § 1819(g)(2)(A) (42 U.S.C. § 1395i-3(g)(2)(A)); 42 C.F.R. §§ 488.20(a), 488.308.  The

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Act also authorizes the Secretary to impose enforcement remedies against SNFs that are not in substantial compliance with the program participation requirements.  Act § 1819(h)(2) (42 U.S.C. § 1395i-3(h)(2)).  Among other enforcement remedies, CMS may impose a per-instance CMP for each instance of noncompliance.  42 C.F.R. § 488.430(a).  At the time of the January 2018 survey at issue in this case, the range for a per-instance CMP was $2,097 to $20,965.  42 C.F.R. § 488.438(a)(2); see also 82 Fed. Reg. 9174, 9188 (February 3, 2017).

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

1.      Summary judgment is appropriate.3

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), aff’d sub nom Mission Hosp. Reg’l Med. Ctr. v. Burwell,819 F.3d 1112 (9th Cir. 2016).  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.’”  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) (quoting Matsushita), aff’d sub nom Senior Rehab. & Skilled Nursing Ctr. v. Health & Human Servs., 405 F. App’x 820 (5th Cir. 2010). 

In evaluating a motion for summary judgment, an administrative law judge does not address credibility or evaluate the weight of conflicting evidence.  Holy Cross Village at Notre Dame, Inc.,DAB No. 2291 at 5 (2009).  Rather, in examining the evidence to determine the appropriateness of summary judgment, an administrative law judge must draw all reasonable inferences in favor of 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, 249 (1986).  However, drawing factual inferences in the light most

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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, there is no genuine dispute of material fact.  Many of the parties’ arguments center not on what the facts are, but rather on the legal significance of those facts.  Insofar as Petitioner attempts to raise factual disputes in its brief opposing summary judgment, my analysis in section IV.B.2, infra, shows that those disputes are not material to the issues I must decide.  Consequently, I conclude that summary judgment is appropriate in this case.4

2.      Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d)(1)-(2) (Tag F689) because it failed to provide adequate supervision to prevent Resident 5’s5 smoking accident.

Section 483.25 of 42 C.F.R., which governs quality of care, provides generally that “the facility must ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the resident’s choices.”  Subsection 483.25(d) imposes specific obligations upon a facility to minimize accident hazards and prevent accidents, as follows:

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.

Appellate panels of the Departmental Appeals Board (DAB) have held that the regulations require 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.”  Meadowwood Nursing Ctr., DAB No. 2541 at 2 (2013) (citing Me.

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Veterans’ Home – Scarborough, DAB No. 1975 at 10 (2005)).6  Subsection 483.25(d)(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.”  Briarwood Nursing Ctr., DAB No. 2115 at 11 (2007) (citing Woodstock Care Ctr. v. Thompson, 363 F.3d 583, 590 (6th Cir. 2003) (facility must take “all reasonable precautions against residents’ accidents”)).  Facilities are given “the flexibility to choose the methods” they use to provide supervision or assistive devices to prevent accidents, so long as the chosen methods “constitute an ‘adequate’ level of supervision under all circumstances.”  Windsor Health Care Ctr., DAB No. 1902 at 5 (2003), aff’d sub nom Windsor Health Ctr. v. Leavitt, 127 F. App’x 843 (6th Cir. 2005).

Resident 5 (R5) was 75 years old when he was originally admitted to the facility on September 13, 2017.  CMS Ex. 10 at 10.  He had diagnoses of chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, acute respiratory failure with hypoxia, hypoxemia, and shortness of breath, among others.  Id. at 10-11.  Based on the resident’s COPD and respiratory issues, he had orders for continuous oxygen at 5 liters per minute at all times via nasal cannula.  Id. at 24-26; see also CMS Ex. 25 at 1.  He was also alert, oriented, and able to make his needs and wishes known.  See P. Ex. 1 at 7.  

On December 5, 2017, a few months after admission, the resident underwent a smoking assessment.  CMS Ex. 10 at 41-42.  The resident was assessed to require supervision while smoking and to require the facility to store lighters and cigarettes on the resident’s behalf.  Id. at 41.  His care plan was updated on the same date and documented the resident’s “risk for injury [related to] Smokes tobacco-cigarette products.”  CMS Ex. 25 at 21.  The care plan had a stated goal that R5 “will remain compliant” with the facility’s smoking procedures and “smoking restrictions.”  Id.  Interventions for achieving that goal included the following:

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• Nursing to maintain/monitor lighting/smoking materials in designated smoking area.  Nursing to store smoking materials for resident.7
• Report [the resident’s] non-compliance with facility smoking policy or unsafe smoking practices to supervisor as indicated.
• Supervised smoker.  To wear apron when smoking.

Id.

The facility’s smoking policy in effect on and after December 19, 2016, provided that the facility “shall establish and maintain safe resident smoking practices.”  CMS Ex. 28 at 1.  To implement that policy statement, the facility established certain guidance and requirements, including the following:

10.  Any resident with restricted smoking privileges requiring monitoring shall have the direct supervision of a staff member, family member, visitor or volunteer worker at all times while smoking.

****

13.  Smoking articles for residents WITHOUT independent smoking privileges:

a.  Residents without independent smoking privileges may not have or keep any types of smoking articles, including cigarettes, tobacco, etc., except when they are under direct supervision. 
b.  Smoking shall not be permitted in bed ever.

****

15.  This facility may check periodically to determine if residents have any smoking articles in violation of our smoking policies.  Staff shall confiscate any such articles, and shall notify the Charge Nurse/Unit Manager that they have done so.

Id. at 1-2.

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On the morning of January 14, 2018, the date of the smoking accident, R5 told staff he wasn’t going to use his oxygen unless he smoked a cigarette.  CMS Ex. 10 at 14; P. Ex. 3 at 2.  In response, two staff members counseled him on the hazards of smoking and the need for him to keep his oxygen in place.  P. Ex. 3 at 2; CMS Ex. 10 at 44 (¶ 4); CMS Ex. 10 at 46 (¶ 7).  The resident did not have any cigarettes available to him that morning, but later that day, the resident received a visitor who brought him smoking materials, including cigarettes.  One of the facility’s staff members, Cherokee Hampshire, STNA (State Tested Nursing Assistant), testified in her affidavit that she observed the visitor hand the resident a pack of cigarettes.  CMS Ex. 10 at 49 (¶ 4).  Then, shortly after the visitor left,8 STNA Hampshire observed the resident leave his wheelchair and oxygen in the building and walk outside to the facility’s designated smoking area on the patio.  CMS Ex. 10 at 49 (¶ 5); CMS Ex. 23 at 2; see also CMS Ex. 10 at 46 (¶ 11). 

There is no dispute that several members of Petitioner’s staff were aware that the visitor had given R5 a pack of cigarettes.  As noted, STNA Hampshire observed the visitor do so.  The parties, however, dispute whether staff were aware that R5 had also acquired a lighter.  CMS points out that, according to the surveyor’s notes, another nurse, Amy Wilson, LPN, stated that the resident had informed her that the friend had brought him a pack of cigarettes and a lighter.  CMS Br. at 5-6; CMS Ex. 23 at 2.  Petitioner denies that staff were aware and cites the staff members’ affidavits in support.  P. Br. at 5-6, 13 (“Yes, staff knew [R5] had cigarettes, but not a lighter.”).  For example, STNA Hampshire denied that she ever saw the resident with a lighter and that, “[b]y the time [she] got outside [to find the resident], he already had the cigarette lit.”  CMS Ex. 10 at 49 (¶ 6).  She further testified that she believed one of the other residents smoking on the patio had lit the cigarette for R5.  Id.  Similarly, Nurse Wilson testified that R5 denied having a lighter when she had asked him during his smoke break.  CMS Ex. 10 at 47 (¶ 16); see also CMS Ex. 10 at 14 (nursing note indicating resident “[s]tated didn’t have a lighter”).  For purposes of ruling on CMS’s motion for summary judgment, I accept that, though staff were aware R5 had cigarettes, they were unaware that he also had a lighter in his possession.  The issue is ultimately immaterial, however, as I explain below.

While R5 was smoking outside, he was supervised first by STNA Hampshire and then by Nurse Wilson.  CMS Ex. 10 at 46-47 (¶¶ 14-17), 49 (¶ 6); P. Ex. 3 at 2; see also P. Br. at 14.  Both staff members explained the facility’s smoking policy to the resident and told him that he would need to turn in his cigarettes after his smoke break, but the resident

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refused to comply.  According to both Nurse Wilson and STNA Hampshire, the resident stated that they would have to “pry the cigarettes from his cold, dead hands.”  CMS Ex. 10 at 14, 47 (¶ 16), 49 (¶¶ 6-7); see also CMS Ex. 23 at 2.  After R5 finished his smoke break, Nurse Wilson helped him back to his wheelchair, back inside the building.  CMS Ex. 10 at 47 (¶ 17); see also id. at 14 (“[wheelchair] was left in facility/outside smoking area doors.”).

While Nurse Wilson was supervising the resident during the smoke break, STNA Hampshire searched the resident’s room for any additional smoking materials.  CMS Ex. 10 at 49-50 (¶¶ 8, 14).9  But STNA Hampshire’s sweep of the resident’s room did not reveal any cigarettes or lighters.  Id. at 49 (¶ 8).

Petitioner does not allege that it added any new interventions to address R5’s risk of accident following his return from his smoke break until 7:00 p.m. that evening.  At that time, Petitioner asserts, staff initiated checks on the resident at least every half hour.10  P. Br. at 6-7, 13, 15; see CMS Ex. 10 at 49 (¶ 10) (STNA Hampshire testifying that, “[a]t shift change, I reported to the on-coming STNA that [R5] had cigarettes” and that “[the on-coming STNA] was going to try to get the cigarettes later that night.”).  The resident’s evening nurse, Janet Meade, LPN, testified that she observed R5 in bed at the beginning of her shift and that she did not observe any cigarettes or lighters on him at that time.  CMS Ex. 10 at 56 (¶ 6).

Then, “[a]t approximately 8:00 p.m.,” Nurse Meade was called into R5’s room by STNA Shawn Ruff.  CMS Ex. 10 at 54 (¶ 4), 56 (¶ 7).  Nurse Meade found STNA Ruff in the room, holding pieces of burnt and melted oxygen tubing.  Id. at 14, 56 (¶ 7).  R5 was still in bed, but had “burn marks to [the] right side of [his] neck” and a “scorched neckline” on his shirt.  Id. at 14, 56 (¶ 7).  He was “soaked with water” from having poured a pitcher of water on himself to stop the burning.  Id. at 14, 56 (¶ 7).  At that time, R5 denied smoking, but staff found a pack of cigarettes, a lighter, and a Styrofoam cup with

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two cigarette butts on his bedside stand.  Id. at 56 (¶ 7).  Nurse Meade completed a head to toe assessment and noted burn areas to R5’s neck.  Id. at 14.

Although the resident initially denied he smoked in his room, Petitioner acknowledges that it was “obvious” the resident had been smoking and that “the oxygen generated a fire.”  P. Br. at 7.  R5 was transferred to the hospital for further evaluation and treatment.  CMS Ex. 10 at 14.  He was diagnosed with a second degree burn to the right side of his neck.  CMS Ex. 26 at 7.  His discharge orders were to clean and redress the burn daily for seven days and he was prohibited from smoking “until this problem [was] discussed with [his] attending physician.”  Id.

Based on the undisputed facts described above, I conclude that the facility failed to follow its smoking policy because it did not directly supervise R5 while he had cigarettes in his possession.  Appellate panels of the DAB have held that the accident prevention regulation “does not prescribe any specific accident-prevention method.”  See, e.g., Heritage Plaza Nursing Ctr., DAB No. 2829 at 20 (2017) (citing Lifehouse of Riverside Healthcare Ctr., DAB No. 2774 at 15 (2017)).  Rather, “facilities have flexibility to choose the specific methods as appropriate to their circumstances and to employ reasonably necessary measures to comply with the regulation.”  Id.  The appellate panel in Heritage Plaza went on to explain, “[o]nce a facility adopts a policy that incorporates the measures that are appropriate to assure that residents receive adequate supervision and assistance devices to prevent accidents, however, the facility is held to follow through on them.”  Id.; see also Sheridan Health Care Ctr., DAB No. 2178 at 32 (2008) (observing that a facility’s adoption of a resident care policy supports an inference that the policy was “necessary to attain or maintain resident well-being”).  Consistent with the analysis in Heritage Plaza and Sheridan Health Care, another appellate panel reasoned that a facility’s “failure to comply with its own policies can support a finding that the facility did not achieve compliance with the regulatory standard.”  Bivins Memorial Nursing Home, DAB No. 2771 at 9 (2017); see also Life Care Ctr. of Bardstown, DAB No. 2233 at 22 (2009) (finding that a facility’s failure to comply with its own policies can constitute a deficiency under section 483.25).  Accordingly, Petitioner was out of substantial compliance with 42 C.F.R. § 483.25(d)(1)-(2) because it failed to take all reasonable steps to prevent the smoking accident that occurred. 

Petitioner disputes this conclusion arguing, in essence, that R5’s accident was unforeseeable and unpreventable.  According to Petitioner, it could not have prevented the smoking accident because R5 refused to relinquish his cigarettes and Petitioner’s staff could not confiscate the cigarettes without using force.  P. Br. at 12, 19; CMS Ex. 10 at 47 (¶ 20).  In this regard, Petitioner apparently concedes that it did not follow that portion of its smoking policy prohibiting non-independent smokers from keeping smoking materials on their persons.  Petitioner instead asserts that it could not implement the policy without violating R5’s rights.  On summary judgment, I must draw all reasonable inferences in favor of Petitioner, the non‑moving party.  In light of the evidence of the

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resident’s refusal and his statement that staff would have to “pry” the cigarettes from his “cold, dead hands,” I accept that Petitioner’s staff tried, but were unable, to persuade the resident to surrender the cigarettes and that staff were unable to confiscate the cigarettes without force.  P. Br. at 12, 19; CMS Ex. 10 at 47 (¶ 16), 49 (¶ 6).

Nevertheless, Petitioner’s argument is, at bottom, a straw man.  It assumes that Petitioner’s only choices in response to R5’s refusal to turn over his cigarettes were either to take the cigarettes by force, or allow R5 to retain them without staff supervision.  Contrary to Petitioner’s argument, its own smoking policy offered Petitioner another option for dealing with R5’s refusal to give up his cigarettes:  direct supervision.  See CMS Ex. 28 at 2 (¶ 13); see also CMS Br. at 21 (arguing that “[i]f [R5] refused the search or refused to relinquish the cigarettes, the facility could and should have imposed greater . . . supervision to ensure that he did not have a lighter or until he relinquished his cigarettes”).  Nor has Petitioner argued that direct supervision of R5 would have been impossible.  See CMS Ex. 10 at 44 (¶ 9) (LPN Sarah Secrest testifying that, if she had known R5 had a lighter, she would have placed him on one to one supervision).

Petitioner concedes that R5 “wasn’t supervised at the time of the accident.”  P. Br. at 14.  Petitioner’s position appears to be that staff nevertheless appropriately implemented its smoking policy because the policy “presume[s] staff has knowledge the resident is currently engaged in the act of smoking, thereby triggering the need for supervision.”  P. Br. at 4; see also id. at 20 (contending that “the evidence demonstrates that the staff followed the care plan and the smoking policy when they had knowledge the resident was smoking”).  According to Petitioner, “[c]ommon sense dictates that a healthcare provider can’t supervise an event if they have no knowledge of the event.”  Id. at 20.  Petitioner elaborates that its staff could not have known of the need to supervise R5 because he smoked in his room covertly and did so despite multiple warnings from staff about the dangers.  Id. at 14.  Petitioner adds that R5 assumed the risk of injury by knowingly engaging in dangerous behavior.  Id.  These arguments are unavailing.

First, Petitioner’s argument that it could not have known that R5 required additional supervision following his smoke break is belied by the actions of Petitioner’s staff.  After staff became aware that R5 had cigarettes in his possession and refused to relinquish them, STNA Hampshire searched R5’s room to look for additional smoking materials, including a lighter, but her search revealed none.  CMS Ex. 10 at 49 (¶ 8), 50 (¶ 14).  Then, at approximately 7 p.m., Nurse Meade placed the resident on 30-minute checks.  P. Br. at 13, 15.  These interventions reflect that staff were aware of the risk that R5 might smoke in his room.  Further, the fact that R5 had already refused to comply with the facility’s smoking policy by refusing to turn over his cigarettes made it more likely – not less so – that he might ignore the facility’s rules and warnings against smoking in his

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room.11  Thus, Petitioner took some steps to address the risk that R5 would smoke in his room in violation of facility policy.  However, the steps Petitioner took were not “adequate” to “ensure” that R5’s environment was as free of accident hazards as possible and did not constitute adequate supervision under the circumstances.

STNA Hampshire completed her sweep of the resident’s room during his smoke break, making the sweep inadequate to address the risk that the resident, with cigarettes still in his possession, might later obtain a lighter from another resident or visitor.  Of course, the sweep of R5’s room also failed to address the risk that the resident already had a lighter on his person, which the facility later presumed to be the case.  See P. Br. at 14 (“Clearly, [R5] had all smoking materials on his person – a fact that only became known to staff after the accident.”).

The 30-minute checks, moreover, left gaps in supervision that exposed R5 to unnecessary risk.12  Petitioner does not explain what each “check” entailed or whether they were anything more than momentary visual checks.  In any case, in addition to the resident’s risk of accident between checks, Petitioner did not initiate the checks until the shift change at 7 p.m.  P. Br. at 6-7, 13, 15.  Thus, there were no interventions in place to address the resident’s risk of accident from the time he finished his smoke break until 7 p.m. – a period of at least three hours, during which staff knew the resident had cigarettes, but still left him alone in his room.  See P. Ex. 3 at 2 (documenting the resident’s smoke break at 3:55 p.m. (15:55)).

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Beyond the fact that the interventions Petitioner did implement were inadequate to protect R5 under the circumstances, Petitioner provides no explanation, either in its contemporaneous records or its brief before me, why the facility deviated from its smoking policy.  As described above, the policy prohibited residents without independent smoking privileges, like R5, from having or keeping any type of smoking articles, including cigarettes, tobacco, etc., except when under direct supervision.  CMS Ex. 28 at 2 (¶ 13) (emphasis added).  The language of ¶ 13 is not limited to situations where staff members are aware that a resident is currently in the act of smoking.  Id.  Thus, Petitioner’s staff did not comply with the directive in its smoking policy to provide R5 direct supervision while he was in possession of smoking materials.  In sum, I conclude as a matter of law that, by failing to directly supervise R5 while he had cigarettes in his possession, in violation of its own smoking policy, Petitioner did not comply substantially with 42 C.F.R. § 483.25(d)(1)-(2).

3.      Petitioner has no right to a hearing with respect to the deficiency cited at Tag F925 because CMS did not impose a remedy for that deficiency. 

In addition to disputing the findings related to the smoking accident and Tag F689, Petitioner argues that it should have the opportunity to challenge the deficiency cited at Tag F925, which involved a finding that the facility failed to maintain an effective pest control program, as required by 42 C.F.R. § 483.90(i)(4).  P. Br. at 23-24; CMS Ex. 9 at 1.  Petitioner also cross-moved in favor of summary judgment on the F925 citation, arguing that CMS failed to cite any evidence to support the citation.  Id. at 24-26.  Petitioner contends that, even without a CMP imposed for the deficiency, there are still negative impacts that give rise to a remedy or penalty.  Id. at 23.  Petitioner contends that nursing homes are assessed points based on deficiencies, which, in turn, affect a facility’s star rating in CMS’s Five Star-Program and can lead to placement on a “Special Focus Facility” list and termination from Medicare.  Id. at 23-24.  I reject these arguments.

The hearing rights of a long-term care facility are established by federal regulations at 42 C.F.R. Part 498.  A provider dissatisfied with an initial determination is entitled to further review, but administrative actions that are not initial determinations are not subject to appeal.  42 C.F.R. § 498.3(a), (d).  The regulations specify which actions are “initial determinations” and set forth examples of actions that are not.  With an exception not applicable here, a finding of noncompliance that results in the imposition of a remedy specified in 42 C.F.R. § 488.406 is an initial determination for which a facility may request administrative law judge review.  42 C.F.R. § 498.3(b)(13).  But a facility has no right to a hearing if CMS does not impose one of the specified remedies.  Lutheran Home‑Caledonia, DAB No. 1753 (2000); Schowalter Villa, DAB No. 1688 (1999); Arcadia Acres, Inc., DAB No. 1607 (1997).  The remedy, not the citation of a deficiency, triggers the right to a hearing.  Schowalter Villa, DAB No. 1688 at 3; Arcadia Acres, Inc., DAB No. 1607 at 3.  Where CMS withdraws proposed remedies or otherwise declines to

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impose remedies, Petitioner has no hearing right.  See, e.g., Fountain Lake Health & Rehab., Inc., DAB No. 1985 at 5-6 (2005).

Aside from the per-instance CMP for the F689 deficiency, no other findings of noncompliance resulted in the imposition of a remedy specified in 42 C.F.R. § 488.406.  CMS Ex. 9 at 1-2.  The potential harms Petitioner complains of are not such remedies and the possible adverse consequences Petitioner envisions are speculative.  Moreover, even if the consequences were concrete, appellate panels of the DAB have considered and rejected Petitioner’s precise argument.  For instance, in Columbus Park Nursing & Rehab. Ctr., the panel held that the negative impact of noncompliance findings on a facility’s Five-Star Quality Rating does not create an appeal right.  DAB No. 2316 at 5-9 (2010), aff’d sub nom. Columbus Park Nursing & Rehab. Ctr. v. Sebelius, 940 F. Supp. 2d 805 (N.D. Ill. 2013); see also NMS Healthcare of Hagerstown, DAB No. 2603 at 8 (2014).  Petitioner therefore does not have the right to dispute, and I do not have the authority to review, CMS’s findings of noncompliance with 42 C.F.R. § 483.90(i)(4).

4.      The remedy imposed is reasonable.

Regarding the amount of the CMP, I examine whether a CMP is reasonable by applying 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 in 42 C.F.R. § 488.404; and 4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety.  The absence of culpability is not a mitigating factor.  The factors listed in § 488.404 include:  1) the scope and severity of the deficiency; 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.  Unless a facility contends that a particular regulatory factor does not support the CMP amount that CMS proposed, the administrative law judge must sustain it.  Coquina Ctr., DAB No. 1860 at 32 (2002).

The regulations leave the decision regarding the choice of remedy to CMS, and the amount of the remedy to CMS and the administrative law judge, requiring only that the regulatory factors at §§ 488.438(f) and 488.404 be considered when determining the amount of a CMP within a particular range.  42 C.F.R. §§ 488.408, 488.408(g)(2), 498.3(d)(11); see also 42 C.F.R. § 488.438(e)(2)-(3); Alexandria Place,DAB No. 2245 at 27 (2009); Kenton Healthcare, LLC,DAB No. 2186 at 28-29 (2008).

Here, CMS decided to impose a $20,905 per-instance CMP for Petitioner’s noncompliance, close to the then-maximum amount for a per-instance CMP.13  CMS Ex. 9 at 3.  Applying the regulatory factors, I agree with CMS that the seriousness of the

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deficiency and the facility’s culpability support a finding that the CMP amount is reasonable.  See CMS Br. at 24.

The facility’s noncompliance was extremely serious as it resulted in actual harm to R5, who suffered a second degree neck burn requiring him to be transported to the emergency room.  CMS Ex. 10 at 14; CMS Ex. 26 at 7.  As noted, the resident was on continuous oxygen and, of course, smoking near flowing oxygen, as R5 was able to do in his room, was extremely dangerous given the potential harm not only to R5, but to other facility residents and staff.  See P. Br. at 7 (acknowledging that “the oxygen generated a fire”); see also State Operations Manual, CMS Pub. 100-07, Appendix PP – Guidance to Surveyors for Long Term Care Facilities (Rev. 168, eff. 11‑22‑2017) (allowing facilities to establish policies prohibiting “[s]moking by residents when oxygen is in use” and noting that “any smoking by others near flammable substances is also problematic”)14; CMS Ex. 23 at 2 (surveyor observing during the survey that a “portable oxygen tank was affixed to the back of [R5’s] wheelchair”).

The facility’s culpability also justifies a substantial CMP amount.  Regarding this factor, I find that Petitioner’s failure to comply with its own smoking policy demonstrates a disregard for resident safety.  The facility failed to directly supervise the resident although it knew he had cigarettes with him in his room.  This led directly to R5’s smoking-related injuries and put other residents and staff at risk.  Petitioner points out that the resident “recognized his culpability for the event.”  P. Br. at 17.  But, the resident’s culpability, whatever the extent, does not eliminate the facility’s share, which was significant and therefore justifies an increased CMP. 

Petitioner argues that the CMP is “excessive” considering the facility has a “good survey history” and that it is “not a facility that is accustomed to receiving citations for substandard care.”  Id.  On this issue, CMS asserts that Petitioner “has been consistently cited for noncompliance” and cites electronic data of the facility’s history.  CMS Br. at 24.  In particular, the data show that a CMP was imposed for two citations based on a March 2017 survey.  CMS Ex. 14 at 2.  The citations were not substandard quality of care citations, but if anything, the recent CMP imposed within a year before the survey at issue would support an increased CMP amount, as well.

Finally, Petitioner does not claim that its financial condition affects its ability to pay the CMP.  Gilman Care Ctr., DAB No. 2357 at 7 (2010) (facility bears the burden of proving its financial condition by the preponderance of the evidence).

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Overall, the seriousness of the deficiency and the facility’s culpability fully justify the CMP amount in this case, even without considering the facility’s compliance history.  I therefore conclude that the $20,905 per-instance CMP imposed here is reasonable.

V.    Conclusion

For the reasons explained above, I conclude that the undisputed facts of record demonstrate that Petitioner was not in substantial compliance with the participation requirements at 42 C.F.R. § 483.25(d)(1)-(2).  I further conclude that the $20,905 per‑instance CMP imposed here is reasonable.  In light of the foregoing, I grant CMS’s motion for summary judgment and deny Petitioner’s cross-motion for summary judgment.

• 1. The state agency completed another survey in this same cycle on March 29, 2018, which found the facility out of substantial compliance with Tag F624.  CMS Exs. 5, 13.  Nevertheless, the facility corrected this deficiency and returned to substantial compliance before any remedy went into effect.  CMS Ex. 8 at 1‑2; CMS Ex. 9 at 2.
• 2. As I discuss in the next paragraph, I exclude Mr. Tucker as a witness, because his proffered testimony relates to an issue that is not before me.  It is not practicable to exclude a portion of CMS Ex. 10.  However, I do not consider pages 52-53 of CMS Ex. 10 in reaching my decision.
• 3. My conclusions of law appear as numbered headings in bold italic type.  My findings of undisputed fact appear in the supporting text.
• 4. CMS requested to cross-examine all of Petitioner’s proposed witnesses and Petitioner requested to cross-examine CMS’s sole proposed witness.  Because I find that summary judgment is appropriate in this case, however, such cross-examination is not necessary.
• 5. To protect the resident’s privacy, I refer to him by the numerical identifier assigned during the survey.  See CMS Ex. 20 at 1.
• 6. In 2016, CMS issued a final rule that re-designated and revised the provisions of 42 C.F.R. Part 483.  See Final Rule, Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities, 81 Fed. Reg. 68,688, 68,828 (Oct. 4, 2016).  Prior to 2016, the content of subsections 483.25(d)(1) and (2) was codified at subsections 483.25(h)(1) and (2).  The Meadowwood decision interpreted 42 C.F.R. § 483.25(h)(1) and (2), as did the other decisions cited in this discussion section.  I find it appropriate to rely on the reasoning of these decisions in the present case because there was no substantive change to the language when 42 C.F.R. § 483.25(h)(1) and (2) were re‑codified as § 483.25(d)(1) and (2).
• 7. The care plan indicates that this intervention was initiated January 15, 2018, which was the day following R5’s smoking accident.  CMS Ex. 25 at 21.  However, as noted, the smoking assessment of December 5, 2017, documented that the facility was to store R5’s smoking materials.  CMS Ex. 10 at 41.  The smoking assessment further provided that the resident’s care plan would be “used to assure resident is safe while smoking.”  Id.  It therefore appears that the intervention to store R5’s smoking materials should have been care planned as of December 5, 2017.
• 8. The statement of deficiencies (SOD) and surveyor notes reflect that STNA Hampshire observed R5 going to the smoking area at 3:30 p.m.  CMS Ex. 15 at 11; CMS Ex. 23 at 2.  STNA Hampshire disputes the time; her affidavit reports that she observed R5 “shortly after lunch, not 3:30 p.m.”  CMS Ex. 10 at 49 (¶ 12).  In any event, the exact time at which staff observed R5 smoking is not material to my decision.
• 9. There does not appear to be a dispute that Petitioner’s staff completed a room sweep while the resident was smoking outside.  The SOD indicates that three staff members were unable to confirm whether a room sweep was completed.  CMS Ex. 15 at 10-11; see also CMS Ex. 23 at 2.  However, in its brief, CMS appears to have conceded the point, acknowledging that Mary Yanko, the DON, stated that a nurse went into the resident’s room and was unable to locate a lighter.  CMS Br. at 6.
• 10. Petitioner relies on the affidavit of Nurse Meade (P. Ex. 5) in support of its assertion that its staff initiated 30-minute checks on R5 after 7 p.m.  See, e.g., P. Br. at 7.  I have excluded P. Ex. 5 as filed untimely without good cause.  See pages 2-3, supra.  Nevertheless, for purposes of summary judgment, I accept that Petitioner’s staff implemented 30-minute checks on R5.
• 11. The fact that R5 chose to smoke in his room in violation of Petitioner’s smoking policy does not absolve Petitioner of its duty to protect the resident from accident hazards.  A Medicare-certified SNF, such as Petitioner, is required by Federal statutes and regulations to ensure that its residents remain as free from accident hazards as practicable.  This duty is not limited by common law tort concepts such as assumption of risk.  Moreover, even if R5 could be said to have knowingly assumed the risk of smoking in his room in the presence of oxygen, that would certainly not absolve Petitioner of its duty to protect its other residents from the danger of a fire that might spread beyond R5’s room.  See Century Care of Crystal Coast, DAB No. 2076, at 18 (2007), aff’d sub nom Century Care of the Crystal Coast v. Leavitt, 281 F. App’x 180 (4th Cir. 2008) (“The facility should also have considered the risk to other residents in the event of an oxygen explosion or fire in determining how much reliance to place on [the resident’s] judgment.”).
• 12. Petitioner argues that it couldn’t have reasonably known that the resident would “sneak a cigarette between 30-minute checks.”  P. Br. at 14.  However, had the facility directly supervised the resident, as it was required to under its own smoking policy, the facility would not have had to consider the risks that remained with 30-minute checks.
• 13. The maximum per-instance CMP at the time the remedy was imposed was $20,965.  See 82 Fed. Reg. 9174, 9188 (February 3, 2017).
• 14. Appendix PP (Rev. 168) is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R168SOMA.pdf (last visited July 31, 2020).  The cited quotation appears at PDF page number 293.