Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Generations at Oakton Pavillion
(CCN: 145626),
Petitioner,
v.
Centers for Medicare & Medicaid Services,
Respondent.
Docket No. C-23-697
Decision No. CR6623
DECISION
Following complaint investigation surveys completed on February 10, 2023 and February 28, 2023, by the Illinois Department of Public Health (IDPH), the Centers for Medicare & Medicaid Services (CMS) determined that Petitioner, Generations at Oakton Pavillion, was not in substantial compliance with several Medicare participation requirements. CMS imposed a per-day civil money penalty (CMP) of $1,530 against Petitioner from February 10, 2023 continuing through March 21, 2023, for a total of $61,200.
Petitioner filed an initial appeal, which was docketed under C-23-453. CMS subsequently issued revised initial determinations, and Petitioner then filed another appeal, which was docketed under C-23-697. In the interest of judicial economy, the two cases were consolidated under C-23-697, dismissing C-23-453. CMS filed a partial motion to dismiss in C-23-453, and, following consolidation, filed another partial motion to dismiss in C-23-697.
For the reasons set forth below, I grant CMS’s partial motion to dismiss. Furthermore, I find that Petitioner was not in substantial compliance with multiple Medicare requirements, and CMS’s imposed CMP is reasonable.
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I. Background and Procedural History
Petitioner is a skilled nursing facility (SNF) located in Des Plaines, Illinois. Joint Stipulation of Undisputed Facts (Jt. Stip.) at 1. Based on complaints it received, the IDPH conducted an investigation survey of Petitioner’s facility on February 10, 2023. Jt. Stip. at 1.
Based on the February 10, 2023 survey, the IDPH found that Petitioner was not in substantial compliance with four Medicare requirements:
(1) 42 C.F.R. § 483.10(c)&(g) (Tag F578), Scope and Severity (S/S) level D (an isolated deficiency that does not cause actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy)
(2) 42 C.F.R. § 483.25 (Tag F684), S/S level D (an isolated deficiency that does not cause actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy)
(3) 42 C.F.R. § 483.25(b)(1) (Tag F686), S/S level G (an isolated deficiency that involves actual harm but does not pose immediate jeopardy to resident health or safety)
(4) 42 C.F.R. § 483.25(d) (Tag F689) S/S level D (an isolated deficiency that does not cause actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy)
CMS Ex. 1; Jt. Stip. at 2.
Based on the February 28, 2023 revisit survey, the IDPH found that Petitioner was not in substantial compliance with six Medicare requirements:
(1) 42 C.F.R. § 483.10(g) (Tag F580), S/S level D (an isolated deficiency that does not cause actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy)
(2) 42 C.F.R. § 483.12(a)(1) (Tag F600), S/S level G (an isolated deficiency that involves actual harm but does not pose immediate jeopardy to resident health or safety)
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(3) 42 C.F.R. §§ 483.10(e) and 483.12(a)(2) (Tag F604), S/S level G (an isolated deficiency that involves actual harm but does not pose immediate jeopardy to resident health or safety)
(4) 42 C.F.R. § 483.25 (Tag F684), S/S level G (an isolated deficiency that involves actual harm but does not pose immediate jeopardy to resident health or safety)
(5) 42 C.F.R. § 483.25(d) (Tag F689), S/S level G (an isolated deficiency that involves actual harm but does not pose immediate jeopardy to resident health or safety)
(6) 42 C.F.R. § 483.25(e) (Tag F690), S/S level D (an isolated deficiency that does not cause actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy)
CMS Ex. 3; Jt. Stip. at 6.
Based on these findings, CMS issued an initial determination dated June 23, 2023. CMS Ex. 10. CMS determined that Petitioner was not in substantial compliance, noting the most serious deficiency was cited at S/S level G for Tag F686. CMS Ex. 10 at 1. The notice imposed a federal civil money penalty (CMP) of $1,530 per day for a total of 40 days, beginning February 10, 2023 and continuing through March 21, 2023, totaling $61,200. CMS Ex. 10 at 2. CMS also notified Petitioner that it is subject to a Nurse Aide Training and Competency Evaluation Program (NATCEP) prohibition for two years because the CMP amounted to $11,995 or more. CMS Ex. 10 at 4. The notice also imposed a Discretionary Denial of Payment for New Medicare and Medicaid Admissions from March 10, 2023 through March 21, 2023. CMS Ex. 10 at 2.
Following the completion of an Independent Informal Dispute Resolution, IDPH deleted Tag F836D from the statement of deficiencies. CMS Ex. 55 at 5. An amended Statement of Deficiencies was issued which did not result in any change to the imposed or recommended remedies. CMS Ex. 55 at 5.
Petitioner initially filed a hearing request on May 5, 2023 based on the March 7, 2023 notice from IDPH. That case was docketed under C-23-453. On August 22, 2023, Petitioner filed another hearing request to appeal CMS’s June 23, 2023 notice. That case was docketed under C-23-697. On September 13, 2023, Administrative Law Judge Jacinta Alves issued an Acknowledgment and Consolidation Order, in which she dismissed C-23-453 and consolidated both cases under C-23-697, as well as reissued Judge Alves’ Standing Prehearing Order (SPO).
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On September 29, 2023, CMS filed a partial motion to dismiss. CMS then filed its prehearing exchange on December 12, 2023 in accordance with Judge Alves’ SPO. CMS included its prehearing brief (CMS PH. Br.), along with 56 exhibits (CMS Exs. 1-56), and a list of five proposed witnesses.
On October 18, 2023, Petitioner filed a response to the partial motion to dismiss. Petitioner then filed a prehearing exchange consisting of a prehearing brief (P. P. Br.), four exhibits (P. Exs. 1-4), and objections to five of CMS’s proposed exhibits.
On November 1, 2023, CMS filed a reply brief in support of its motion for partial dismissal (CMS Reply). On January 31, 2024, CMS filed a response to Petitioner’s evidentiary objections, a notice it would not file a reply brief to Petitioner’s prehearing exchange, and objections to two of Petitioner’s proposed exhibits.
On February 12 and 13, 2024, the parties filed a joint statement of issues, joint stipulation of undisputed facts, and a joint settlement status report in which the parties waived an oral hearing and requested a decision on the written record. The parties subsequently filed a motion requesting the opportunity for additional briefing, which was granted, and filed supplemental briefs (CMS Br. and P. Br.) on April 8, 2024.
This case was transferred to me on January 24, 2025.
A. Evidentiary Objections
Petitioner objected to CMS Exhibits 19, 20, 21, 46, and 47 on the basis of hearsay. While they can be used as guidance, the Federal Rules of Evidence do not govern these proceedings. See 42 C.F.R. § 498.61 (“[e]vidence may be received at the hearing even though inadmissible under the rules of evidence applicable to court procedure”). The regulations that govern these proceedings state that an Administrative Law Judge (ALJ) “inquires fully into all of the matters at issue, and receives in evidence . . . any documents that are relevant and material.” 42 C.F.R. § 498.60(b)(1).
CMS Exhibits 19, 20, 21, 46, and 47 are surveyor notes. Petitioner objected to these exhibits on the basis of hearsay, and that “[t]here is no guarantee of accuracy as these interviews and documents are not transcribed word for word.” Petitioner’s Objections at 1-2. In this administrative hearing, hearsay is not grounds to exclude an exhibit, and the survey notes are relevant and material to the survey forming the basis of the citations. Therefore, the survey notes are admissible. Any contended inaccuracies within the survey notes will be considered in light of the total evidence in the record.
I overrule Petitioner’s objections to the aforementioned exhibits. I admit CMS Exhibits 1-56 to the record.
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CMS objected to Petitioner’s Exhibit 2 on the basis of relevancy and Exhibit 3 as unsworn witness testimony from a person not on the proposed witness list. I admit Exhibits 2 and 3, but consider CMS’s objections in determining what weight, if any, to give the exhibits. I admit P. Exhibits 1-4 to the record.
B. Ruling on CMS’s Partial Motion to Dismiss
In its August 22, 2023 request for hearing, Petitioner states it is contesting the imposition outlined in the June 23, 2023 initial determination. Petitioner states further that it contests the imposed penalties and the DPNA. August 22, 2023 Request for Hearing at 1. Petitioner also requested that CMS refrain from using the disputed citations proposed to calculate the facility’s 5 Star Quality Rating on CMS’s Nursing Home Compare website until an ALJ issued a decision in the matter. Id. at 1-2.
In its partial motion to dismiss, CMS moved to partially dismiss Petitioner’s appeal under 42 C.F.R. § 498.70(b). CMS argues that Petitioner’s appeal should be dismissed as to:
(1) the various CMS actions pursuant to statute, regulation, and policy that are not remedies, including CMS’ recalculation of Petitioner’s Star Rating and the posting of Petitioner’s deficiencies and a consumer alert on Care Compare;
(2) the scope and severity level of the imposed deficiencies; and
(3) the selection of remedies.
CMS partial motion to dismiss (CMS Mot.) at 4. CMS contends that none of these actions is appealable under 42 C.F.R. § 498.3. Id. CMS argues that “neither a reduction in Star Rating nor the posting of deficiencies or a consumer alert to CMS’ Care Compare website or availability elsewhere nor any of the other actions are enumerated enforcement remedies under 42 C.F.R. § 488.406.” Id. CMS cites 42 C.F.R. § 498.3, as well as Generations at Regency Center, DAB No. 2950 (2019), in support of its argument. Id at 4-5.
CMS argues that Petitioner does not have the right to contest the “scope or severity of the imposed deficiencies or CMS’ choice of remedies.” CMS Mot. at 6. CMS contends that a successful challenge to the scope or severity would not affect the range of the CMP, as there was no finding of immediate jeopardy, or substandard quality of care. CMS Mot. at 6. The regulations provide for a different (i.e., higher) per-day CMP range only for immediate jeopardy level deficiencies, and limit Petitioner’s right to appeal CMS’s selection of remedies. 42 C.F.R. § 488.438(a); 42 C.F.R. § 488.408(g)(2). The CMP is the only enforcement remedy imposed on Petitioner for which Congress has provided the right to a formal Administrative Procedure Act (APA) hearing. 42 U.S.C. § 1395i-
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3(h)(2)(B)(ii)(I); see 5 U.S.C. §§ 554(a), 556(a)-(b); 42 U.S.C. § 1320a-7a(c)(2). The Star Rating is not an enforcement remedy listed in 42 C.F.R. § 488.406. Lastly, Petitioner cannot appeal the scope and severity levels imposed, as there was no finding of immediate jeopardy. As the ranges for per-day CMPs are only different for deficiencies cited at immediate jeopardy, a challenge to the level of noncompliance could not result in a change to the CMP range amount. Therefore, the level of noncompliance here is not an initial determination and is not subject to appeal in this proceeding. 42 C.F.R. § 498.3(b)(14); 42 C.F.R. § 488.438(a). Additionally, “[a] Facility may not appeal the choice of remedy, including the factors considered by CMS or the State in selecting the remedy, specified in § 488.404.” 42 C.F.R. § 488.408(g)(2). For these reasons, I grant CMS’s motion.
II. Issues
The issues in this case are:
Whether Petitioner was in substantial compliance with Medicare requirements at 42 C.F.R. §§ 483.10(c), (g); 483.25; 483.25(b)(1); 483.25(d); 483.10(g); 483.12(a)(1); 483.10(e); 483.12(a)(2); 438.25(d); and 483.25(e);
and
If Petitioner was not in substantial compliance, whether the amount and duration of the CMP imposed on Petitioner is reasonable under the factors in 42 C.F.R. § 488.438(f).
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), 1395i3(h)(2)(B)(ii)); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).
IV. Discussion
A. Applicable Legal Authority
The Act sets requirements for SNFs to participate in the Medicare program and authorizes the Secretary of Health and 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.
To participate in the Medicare program, a SNF must maintain substantial compliance with program requirements. To be in substantial compliance, a facility’s deficiencies
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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 the participation requirements. Act § 1864(a) (42 U.S.C. § 1395aa(a)); 42 C.F.R. § 488.10, 488.20. The Act and its implementing regulations require that facilities be surveyed on average every 12 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 state agency must also investigate all complaints. Act § 1819(g)(4) (42 U.S.C. § 1395i-3(g)(4)).
The regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance with Medicare requirements. 42 C.F.R. § 488.406. Among other remedies, CMS is authorized to impose a per-day CMP for the number of days a facility is not in substantial compliance or a per-instance CMP for each instance of the facility’s noncompliance. 42 C.F.R. § 488.430(a). In this case, CMS imposed a per-day CMP. The regulations specify that a per-day CMP will fall into one of two ranges of penalties. 42 C.F.R. §§ 488.408, 488.438. The upper range, $7,317 to $23,989 per day, is reserved for deficiencies that pose immediate jeopardy to a facility’s residents, and, in some circumstances, for repeated deficiencies.1 42 C.F.R. § 488.438(a)(1)(i), (d)(2); 45 C.F.R. § 102.3 (Table) (2022). The lower range, $120 to $7,195 per day, is reserved for deficiencies that do not pose immediate jeopardy, but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm. 42 C.F.R. § 488.438(a)(1)(ii); 45 C.F.R. § 102.3 (Table).
Petitioner was also notified that it would be ineligible to conduct a NATCEP. Pursuant to 42 C.F.R. § 483.151(b)(2) and (f), a state may not approve and must withdraw any prior approval of a NATCEP offered by a SNF or nursing facility that has been: (1) subject to an extended or partial extended survey under sections 1819(g)(2)(B)(i) or 1919(g)(2)(B)(i) of the Act; (2) assessed a CMP of not less than $11,995 (45 C.F.R. § 102.3 (Table) (2022)); or (3) subject to termination of its participation agreement, a DPNA, or the appointment of temporary management. Ineligibility or withdrawal of approval to conduct a NATCEP is mandatory if the conditions are satisfied. See 42 C.F.R. § 488.406.
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If CMS imposes a remedy based on a noncompliance determination, such as a CMP, then the facility may request a hearing before an ALJ to determine whether there was a basis for the deficiency findings that led to the imposition of the remedy and whether the CMP imposed was reasonable. Act §§ 1128A(c)(2), 1819(h)(2)(B)(ii) (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). However, the facility may not appeal CMS’s choice of remedies or the factors CMS considered in selecting remedies. 42 C.F.R. § 488.408(g)(2).
A facility may challenge CMS’s determination as to the scope and severity of noncompliance only if a successful challenge would affect the range of the CMP that may be imposed, or impact the facility’s authority to conduct a NATCEP. 42 C.F.R. § 498.3(b)(14), (d)(10)(i). The CMS determination as to the level of noncompliance, including the finding of immediate jeopardy, “must be upheld unless it is clearly erroneous.” 42 C.F.R. § 498.60(c)(2); Woodstock Care Ctr., DAB No. 1726 at 9, 39 (2000), aff’d, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003). The Departmental Appeals Board (Board) has held that the net effect of the regulations is that a provider has no right to challenge the scope and severity level assigned to a noncompliance finding, except in the situation where that finding was the basis for an immediate jeopardy determination. See, e.g., Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750 (2000). ALJ review of a CMP is subject to the parameters set forth in 42 C.F.R. § 488.438(e).
B. Findings of Fact, Conclusions of Law, and Analysis
1. Petitioner did not contest its noncompliance with 42 C.F.R. § 483.25 and § 483.10(c) & (g) from the first survey and 42 C.F.R. § 483.25(d)(2) and § 483.25(e)(1)-(3) from the second survey.
2. Resident 5 had a pressure ulcer upon admission to Petitioner’s facility.
3. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(b)(1) (Tag F686), because Petitioner failed to take appropriate measures to promote the healing of Resident 5’s pressure ulcer.
CMS alleges that Petitioner “failed to ensure Resident 5’s wound VAC machine remained on and connected to the wound as ordered.” CMS Br. at 6. At the time of admission to Petitioner, Resident 5 had a stage 4 sacrum pressure ulcer and had a negative pressure therapy (wound VAC) machine attached to the wound. Jt. Stip. at 2. The wound measured 11 cm by 8 cm by 2 cm. Id. Resident 5’s physician entered an order to connect the sacrum pressure ulcer to the wound VAC. Id. Resident 5’s care plan included the use of the wound VAC and stated that if the wound VAC seal was broken or
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the alarm failed, the wound VAC should be removed, moist dressing applied and the doctor notified. Id.
On December 26, 2022, a progress note for Resident 5 reported that the wound VAC was not sealed, the wound VAC dressing was completely soaked, and the wound had a foul odor, erythema and maceration. Jt. Stip. at 3. It was also noted that the wound VAC had been turned off and that it was unknown how long it had been turned off. Id. Resident 5 was sent to the hospital on December 30, 2022, after a wound culture showed a heavy growth of bacteria present in the sacrum pressure ulcer. Id. At the time of admission to the hospital, the wound measured 15 cm x 15 cm and had purulent draining with a foul odor. Id. at 4.
With respect to quality of care for skin integrity, the regulations at the time of survey provide that:
Based on the comprehensive assessment of a resident, the facility must ensure that—
(i) A resident receives care, consistent with professional standards of practice, to prevent pressure ulcers and does not develop pressure ulcers unless the individual’s clinical condition demonstrates that they were unavoidable; and
(ii) A resident with pressure ulcers receives necessary treatment and services, consistent with professional standards of practice, to promote healing, prevent infection and prevent new ulcers from developing.
42 C.F.R. § 483.25(b)(1).
Under the quality of care regulation, a facility is required to “provide the care and services necessary to attain or maintain a resident’s highest practicable well-being.” Act § 1819(b); 42 C.F.R. § 483.25; Spring Meadows Health Care Ctr., DAB No. 1966 at 14 (2005). The Board has explained that 42 C.F.R. § 483.25 imposes a duty that a facility must provide care and services that, at a minimum, meet accepted “professional standards of quality.” Spring Meadows, DAB No. 1966 at 17 (citing 42 C.F.R. § 483.25). When assessing a facility's compliance with this regulatory requirement, the question is whether the facility took “all necessary precautions” to promote healing. Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300 at 13-14 (2010), aff’d, Senior Rehab. & Skilled Nursing Ctr. v. Health & Human Servs., 405 F. App’x 820 (5th Cir. 2010); Koester Pavilion, DAB No. 1750 at 32 (2000). And if the evidence establishes that the facility fell short of taking all necessary precautions, it has violated the regulation. See id.
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CMS contends that Petitioner’s treatment of Resident 5’s wound falls short of the requisite standard of care in contravention of 42 C.F.R. § 483.25(b)(1), and I agree. See CMS Br. at 7. In support, CMS provided as evidence a declaration from the Surveyor testifying to the relevant standards of care for a resident admitted with a Stage 4 pressure ulcer and a wound VAC. CMS Ex. 25. The Surveyor is now a Public Service Administrator at IDPH with over 10 years of long-term care experience in positions including as a registered nurse at a hospital and associated clinics providing nursing care for patients with wounds and the use of wound VACs. CMS Ex. 25 at 1. The Surveyor testified that in her professional opinion, Petitioner was out of compliance with 42 C.F.R. § 483.25(b)(1) because it failed to ensure Resident 5’s wound VAC was on continuously, resulting in the pressure wound becoming infected and requiring hospitalization. CMS Ex. 25 at 3. The Surveyor further testified that a complaint had been received stating that the vacuum pump on Resident 5’s wound VAC had lost its seal on December 24, 2022, but that Petitioner had no taken action. Id. She further stated that the complaint indicated that when action was taken on December 26, 2022, an infection had set in and Resident 5 had to be hospitalized. Id. The Surveyor also testified that when reviewing Resident 5’s medical records she noted that wound VAC had no seal on December 26, 2022, and that the dressing was soaked. Id. Lastly, the Surveyor testified that the condition of the wound supports that the wound VAC seal had failed for a lengthy period of time without any action having been taken. Id. at 4. I find the Surveyor’s testimony credible, and Petitioner has not offered any rebuttal testimony into evidence.
Petitioner argues that Resident 5 arrived at the facility with a wound in a condition that indicates wound healing was all but impossible. P. Br. at 7. However, Petitioner does not explain why the Resident’s plan of care was not followed and why it failed to ensure that Resident 5’s wound VAC machine was turned on. See Heritage Plaza, DAB No. 2829 at 20 (2017) (Where . . . a resident’s care plan requires staff to take specific measures in caring for a resident, the Board has repeatedly held that those measures reflect the facility’s own determination of what it must do to attain or maintain . . . the overarching quality-of-care requirement.”) (citations omitted).
With respect to Resident 5, Petitioner did not ensure that a “resident with pressure sores receives the necessary treatment and services to promote healing, prevent infection and prevent new sores from developing.” The Harborage, DAB No. 2905 at 1-2 (2018). As such, Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(b)(1).
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4. Resident 3 was admitted to Petitioner from a hospital on January 20, 2023. The hospital discharge instructions and the notes from Resident 3’s admission included wearing a mitten on both hands because he was trying to grab his tracheostomy tube.
5. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d) (Tag F689), because Petitioner failed to ensure Resident 3 received adequate supervision and assistance devices to prevent accidents.
Petitioner was cited for not substantially complying with 42 C.F.R. § 483.25(d). Under section 483.25(d), facilities must ensure, based on a resident’s comprehensive assessment, 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(d).
To provide a resident adequate supervision consistent with 42 C.F.R. § 483.25(d)(2), a facility has flexibility to choose how to supervise a resident, but the measure chosen must be able to reduce known or foreseeable accident risks to the highest practicable degree. Heritage Plaza Nursing Ctr., DAB No. 2829 at 6, 20 (2017). Additionally, a facility’s obligations under section 483.25 also includes furnishing the care and services set forth at its own resident care policies. Life Care Ctr. of Bardstown, DAB No. 2479 at 22 (2012).
Resident 3
Resident 3 was admitted to Petitioner on January 20, 2023. The hospital discharge instructions and the admission notes included that Resident 3 wear mittens to prevent him from removing his tracheostomy tube. Jt. Stip. at 4. A patient wearing restraint mittens would not be able to remove them unless the mittens were not secured properly, and the patient was flailing. Id. On January 21, 2023, V8, an RN, found Resident 3 in his room with his tracheostomy and g-tubes pulled out and his mittens off. Id.
CMS contends that Petitioner failed to ensure Resident 3 wore his physician-ordered restraint mittens in violation of 42 C.F.R. § 483.25(d). I agree. In support, CMS provided the testimony of the Surveyor. CMS Ex. 23. The Surveyor testified that Resident 3 had a physician’s order to wear mittens because he had a history of pulling on
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his tracheostomy and g-tubes. CMS Ex. 23 at 4. She testified that with two mittens on, it is very difficult to grab anything and extremely difficult to pull out a tube. Id. She further explained that in her nine years of working as a nurse in a hospital, she never saw a patient pull out a tracheotomy or g-tube while wearing mittens. Id. at 4-5. The Surveyor also testified that V8 told her that she found Resident 3 with his mittens off and that Resident 3 should not have been able to pull out the tubes with his mittens on. Id. at 5. Lastly, she testified that a patient would not be able get the mittens off unless they were not properly secured and the patient was flailing. Id.
Petitioner argues that Resident 3 may have been able to remove the mittens himself. P. Br. at 9. Petitioner also states that Resident 3’s mittens were removed when his family visited. P. Br. at 9; CMS Ex. 16 at 27. Petitioner further argues that the medical records support that the mittens were reapplied after the family left. Id. Lastly, Petitioner argues that the evidence supports that Resident 3 removed the mittens himself prior to pulling out his tubes. P. Br. at 10. To further support its argument, Petitioner submitted the unsworn statement of Lynn Cerrado, the Assistant Nursing Director. P. Ex. 3. Nurse Cerrado states that she reviewed the statement of deficiencies and concludes that restraint “mittens were re-applied by the nurse when the family left.” Id.
However, I find that the evidence does not support Petitioner’s arguments. Resident 3 was found without his restraint mittens and his tubes removed. As a result, either Resident 3’s mittens were not applied properly or were not re-applied following his family visit. Either way, Resident 3 was not properly supervised in a manner sufficient to prevent him from pulling out both his tracheostomy and gastrostomy tubes. Therefore, I find that Petitioner failed to ensure that each resident received adequate supervision and assistance devices to prevent accidents pursuant to 42 C.F.R. § 483.25(d).
6. Petitioner was not in substantial compliance with 42 C.F.R. § 483.10(g) (Tag F580), 42 C.F.R. § 483.12(a)(1) (Tag F600), 42 C.F.R. § 483.10(e) (Tag F604) and 42 C.F.R. § 483.12(a)(2) (Tag F604) because Petitioner failed to protect Resident 3 from verbal, mental or physical abuse; failed to ensure that Resident 3 was free from physical restraints imposed for the purposes of discipline or convenience; and failed to immediately inform Resident 3’s representatives of a significant change in her status.
With respect to Resident 3, Petitioner was cited for noncompliance with 42 C.F.R. § 483.10(g)(14)(i)(B) because of its failure to notify Resident 3’s representatives of a significant change in her condition. The regulation states that:
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(14) Notification of changes.
(i) A facility must immediately . . . notify, consistent with his or her authority, the resident representative(s), when there is—
* * *
(B) A significant change in the resident’s physical, mental, or psychosocial status (that is, a deterioration in health, mental, or psychosocial status in either life-threatening conditions or clinical complications).
42 C.F.R. § 483.10(g)(14)(i)(B).
With respect to Resident 3, Petitioner was also cited for noncompliance with 42 C.F.R. § 483.12(a)(1) because of its failure to protect Resident 3 from verbal, mental or physical abuse. The regulation states that:
(a) The facility must—
(1) Not use verbal, mental, sexual, or physical abuse, corporal punishment or involuntary seclusion;
42 C.F.R. § 483.12(a)(1).
Lastly, with respect to Resident 3, Petitioner was also cited for noncompliance with 42 C.F.R. §§ 483.10(e) and 483.12(a)(2) because it failed to ensure that Resident 3 was free from physical restraints imposed for purposes of discipline or convenience. The regulations state that:
(e) Respect and dignity. The resident has a right to be treated with respect and dignity, including:
(1) The right to be free from any physical or chemical restraints imposed for purposes of discipline or convenience, and not required to treat the resident’s medical symptoms . . . [.]
42 C.F.R. § 483.10(e)(1).
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(a) The facility must—
(2) Ensure that the resident is free from physical or chemical restraints imposed for purposes of discipline or convenience and that are not required to treat the resident’s medical symptoms. When the use of restraints is indicated, the facility must use the lease restrictive alternative for the least amount of time and document ongoing re-evaluation of the need for restraints.
42 C.F.R. § 483.12(a)(2).
The parties agree that on February 16, 2023, Nurse V19 shoved Resident 3 into her wheelchair after she repeatedly tried to stand up. Jt. Stip. at 6. V19 then wheeled Resident 3 into the hallway where he appeared to yell, pointing in her face with his finger and making a second lunging motion. Id. V19 then restrained Resident 3 to her wheelchair with two plastic bags tied together. Id. Nurse V18 approached V19 and asked about the restraints. Id. V18 then reported the information to the Administrator. Id. On February 18, 2023, Resident 3 was evaluated at the hospital and was diagnosed with a neck strain. Id. On February 21, 2023, Resident 3 was observed to have a linear reddened area on her back that had not previously been noted by Petitioner’s staff. Id.
Resident 3 had a diagnosis of dementia as well as severe cognitive impairment. Jt. Stip. at 6.
Petitioner informed V25, Resident 3’s Power of Attorney for Health Care and her emergency contact, of V19’s conduct towards Resident 3 on the evening of February 17, 2024. Jt. Stip. at 7.
Petitioner’s Facility Abuse Prevention Guidance states that it “affirms the right of our residents to be free from abuse” by staff and prohibits the abuse and mistreatment of residents. Jt. Stip. at 7; CMS Ex. 40. The Guidance further states that the facility will assure that physical restraints are used sparingly and properly. CMS Ex. 40 at 1. The Guidance also states that “all instances of abuse of residents, even those in a coma, cause physical harm or pain or mental anguish.” Jt. Stip. at 7.
Petitioner’s Facility Policy Regarding Physical Restraints states that the use of physical restraints shall be limited to situations necessary to maximize a resident’s physical, mental and psychosocial well-being and to treat the resident’s medical symptoms. Jt. Stip. at 7; CMS Ex. 41 at 1. The Policy also states that physical restraints shall not be used for staff convenience or as a punitive measure. Id.
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CMS asserts that the evidence establishes Petitioner’s non-compliance with the above cited regulations: 42 C.F.R. § 483.12(a)(1); 42 C.F.R. § 483.10(e)(1); 42 C.F.R. § 483.12(a)(2); and 42 C.F.R. § 483.10(g). I agree. Petitioner admits that V19 forced Resident 3 back into her wheelchair and utilized plastic bags as a restraint. P. Br. at 12‑16. The police report created by the Des Plaines Police Department includes a review of video footage taken during the incident involving V19 and Resident 3. CMS Ex. 37 at 7. The police report states that the video shows V19 shoving Resident 3, lunging at her, and restraining her with plastic bags. Id. A similar report is included in the February 28, 2023, Statement of Deficiencies. CMS Ex. 3 at 2-3. The police report further states that the investigating officer spoke with V18 who told him she reported the improper use of restraints to the lead administrator on February 16, 2023. CMS Ex. 37 at 7. This is also supported by the video review which shows V18 entering the elevator to report the incident following her discussion with V19. Id.
Petitioner asserts that it was not aware of the alleged abuse until February 17, 2023 and was, therefore, under no obligation to report anything to Resident 3’s representative. P. Br. at 12. However, the evidence does not support such a conclusion. Rather, it is clear that Petitioner was aware of the incident shortly after it occurred on February 16, 2023. After being told that V19 used improper restraints on Resident 3, Petitioner should have recognized the use of plastic bags as restraints constituted abuse and notified Resident 3’s representative.
Petitioner admits that V19’s action violated facility policy and V19 was ultimately terminated. P. Br. at 13. Petitioner argues that there was no actual harm to Resident 3 and, therefore, a citation at scope and severity level G is improper. Id. at 14-15. As noted above, Petitioner cannot appeal the scope and severity of these deficiencies. However, Petitioner’s own Facility Policy Regarding Physical Restraints states that all instances of physical abuse cause harm. As a result, the evidence supports CMS’s conclusion that there was actual harm.
Given the facts detailed above, Petitioner failed to substantially comply with these requirements.
7. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25 (Tag F684), because Petitioner failed to promptly follow an order to obtain a urine sample from Resident 1.
With respect to Resident 1, Petitioner was cited for noncompliance of 42 C.F.R. § 483.25 because of its failure to promptly follow a physician’s order to obtain a urine sample to diagnose a urinary tract infection. The regulation states that:
The facility must ensure that residents receive treatment and care in accordance with professional standards of practice, the
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comprehensive person-centered care plan, and the resident’s choices . . . [.]
42 C.F.R. § 483.25.
The parties agree Resident 1 had a physician order for an indwelling catheter. Jt. Stip. at 8. There had been some issues with a leak in Resident 1’s catheter which lead to it being changed on January 26, 2023. Id. at 9. The surveyor testified that the advanced nurse practitioner examined Resident 1 on January 26, 2023 and noted that Resident 1’s urine culture showed “signs of mixed flora – contamination – will recollect.” CMS Ex. 51 at 4. She further testified that the standard of care following the advanced nurse practitioner’s notes was to review the plan, enter the order, recollect the sample, and send to the lab. Id. Further, the evidence shows and the parties agreed that incorrect catheter and balloon sizes were used on January 14, 2023, January 23, 2023, and January 28, 2023. Jt. Stip. at 8-9. Also, Resident 1’s physician expected to be notified if the urine output was less than 150 ml during an 8 hour shift. CMS Ex. 51 at 4. However, the report did not occur on February 4 and February 5, 2023 when Resident 1’s output was less than 150 ml. At other times, Resident 1’s output was only measured as medium or large. Id.
Petitioner argues that the facility provided proper care to Resident 1 and that Resident 1 did not suffer any harm. P. Br. at 19. Petitioner’s argument regarding proper care is unsupported. And the argument challenging the scope and severity is not within my jurisdiction. As a result, given the facts detailed above, Petitioner failed to substantially comply with the requirements found at 42 C.F.R. § 483.25.
8. The imposed CMP is reasonable.
I have concluded that Petitioner violated 42 C.F.R. §§ 483.10(c) & (g) (Tag F578), 483.25 (Tag F684), 483.25(b)(1) (Tag F686), 483.25(d) (Tag F689) 483.10(g) (Tag F580), 483.12(a)(1) (Tag F600), 483.10(e) & 483.12(a)(2) (Tag F604), 483.25 (Tag F684), 483.25(d) (Tag F689), and 483.25(e) (Tag F690).
In determining whether the CMP imposed against Petitioner is reasonable, I apply 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 42 C.F.R. § 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
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particular regulatory factor does not support the CMP amount, I must sustain it. Coquina Ctr., DAB No. 1860 at 32 (2002).
The Board has explained that “[i]t is settled law that ALJ review of the reasonableness of CMP amounts imposed by CMS is de novo.” Fireside Lodge Retirement Ctr., Inc., DAB No. 2794 at 19 (2017). I consider whether the evidence supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found and in light of the above factors. I am neither bound to defer to CMS’s factual assertions, nor free to make a wholly independent choice of remedies without regard for CMS’s discretion. See, e.g., Barn Hill Care Ctr., DAB No. 1848 at 21 (2002). The Board has explained that “[t]he determination of whether a CMP amount is reasonable is a conclusion of law, not a finding of fact.” Cedar Lake Nursing Home, DAB No. 2344 at 12 (2010), aff’d, Cedar Lake Nursing Home v. U.S. Dep’t of Health & Human Servs., 619 F.3d 453, 457 (5th Cir. 2010).
In assessing the reasonableness of a CMP amount, an ALJ considers the per-day amount, rather than the total accrued CMP. See Kenton Healthcare, LLC, DAB No. 2186 at 28 (2008). Pursuant to 42 C.F.R. § 488.408(g)(2), a facility cannot appeal CMS’s choice of a remedy, and an appeal of a CMP is limited to review based on the regulatory factors set forth at 42 C.F.R. §§ 488.438(f) and 488.404. See, e.g., Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300 at 19-20.
The lower per-day CMP range of $120 to $7,195, as adjusted annually, is applicable to this case, because this range applies to deficiencies that do not constitute immediate jeopardy, but either cause actual harm to residents, or have the potential for causing more than minimal harm. 42 C.F.R. § 488.438(a)(1)(ii); 45 C.F.R. § 102.3 (Table) (2022); 83 Fed. Reg. 51,369, 51,380 (Oct. 11, 2018). Here, CMS imposed a per-day CMP of $1,530 per day for 40 days beginning February 10, 2023 and continuing through March 21, 2023 for a total of $61,200. The $1,530 amount is at the lower end of the penalty range.
In support of its chosen CMP amount, CMS contends that five of the deficiencies cited were severe and at the actual harm level. CMS Br. at 22. CMS also notes that Petitioner’s culpability is high because multiple instances of harm were related to Petitioner’s failure to follow physician’s orders or care plans. Id. CMS also notes that there were two repeat deficiencies from the February 10, 2023 survey at the February 28, 2023 survey. Id.
Petitioner argues the CMP is unreasonable because the deficiencies cited should not have been at the G scope and severity. See P. P. Br. and P. Br. Petitioner does not argue that the CMP duration is unreasonable for the cited deficiencies. However, as found above, actual harm (s/s level G) remains appropriate for the Tag F686, Tag F600, Tag F604, Tag F684, and Tag F689 citations, and Petitioner remains culpable.
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Petitioner has not offered any evidence to establish that it cannot pay the $1,530 per-day CMP.
As noted above, the CMP of $1,530 per day is at the lower end of the applicable penalty range. Accordingly, based on the regulatory factors, I conclude that the $1,530 per-day CMP is reasonable.
9. The imposition of a denial of payment for new admissions is appropriate.
CMS imposed a denial of payment for new Medicare/Medicaid admissions in effect from March 10, 2023 to March 21, 2023. CMS Ex. 10. The DPNA is supported because Petitioner did not return to compliance until March 22, 2023 for 9 out of the 10 deficiencies. CMS Exs. 2, 4. Petitioner does not make an argument as to why the DPNA should be reversed except to argue that it is inappropriate if the scope and severity level of the deficiencies is reduced. See P. P. Br. and P. Br. However, since the scope and severity level of the cited deficiencies has not been changed, this argument is without merit and the DPNA imposed is reasonable.
10. Because CMS imposed a CMP in the total amount of $11,995 or more, CMS is required by law to prohibit Petitioner from having a NATCEP for two years.
In its June 23, 2023 notice letter, CMS informed Petitioner that if it has been assessed a total CMP of not less than $11,995, then it would be prohibited from offering or conducting a NATCEP for two years. CMS stated that the two-year NATCEP prohibition would be effective “for two years from March 10, 2023 . . . . This prohibition remains in effect for the specified period even though other actions relating to remedies are being taken, as indicated above . . . . This prohibition is not subject to appeal.” CMS Ex. 10 at 4.
The inflation-adjusted monetary threshold applicable to this case for the withdrawal of NATCEP approval was $11,995. 45 C.F.R. § 102.3 (Table) (2022). Because the total amount of the CMP assessed in this case is greater than $11,995, CMS is required by law to prohibit Petitioner from having a NATCEP for two years.
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V. Conclusion
For the reasons discussed above, I conclude that Petitioner was not in substantial compliance with the Medicare participation requirements at 42 C.F.R. §§ 483.10(c)&(g); 483.25; 483.25(b)(1); 483.25(d); 483.10(g); 483.12(a)(1); 483.10(e); 483.12(a)(2); 438.25(d); and 483.25(e). A $1,530 per-day CMP from February 10, 2023 and continuing through March 21, 2023, for a total of $61,200, is reasonable. CMS is required by law to prohibit Petitioner from having a NATCEP for two years.
Kourtney LeBlanc Administrative Law Judge
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“Immediate jeopardy means a situation in which 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 (emphasis in original).