Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Generations at Elmwood Park,
(CCN: 145419),
Petitioner,
v.
Centers for Medicare & Medicaid Services.
Docket No. C-22-746
Decision No. CR6611
DECISION
Generations at Elmwood Park (Petitioner or facility), a skilled nursing facility (SNF) that participates in the Medicare program, left a resident (Resident 2) unattended while getting dressed even though Resident 2 was a documented fall risk. As a result of being unattended and unsupervised, Resident 2 fell while attempting to put on her pants and sustained a hip fracture that required an inpatient hospitalization and surgery. Moreover, following the incident, Petitioner failed to immediately consult Resident 2’s physician or notify her family representative.
Based on the results of a complaint survey conducted on January 13, 2022, by the Illinois Department of Public Health (IDPH or state agency), the Centers for Medicare & Medicaid Services (CMS) found that Petitioner was not in substantial compliance with Medicare program participation requirements for SNFs at 42 C.F.R. § 483.25(d)(1), (2) (relating to accident hazards and adequate supervision/devices) as well as 42 C.F.R. § 483.10(g)(14)(i) (notification of changes). CMS imposed a $1,435 per-day civil money penalty (CMP) from January 10, 2022 continuing through January 28, 2022.
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Petitioner disputes that it was not in substantial compliance and argues that Resident 2’s falls were unavoidable and unforeseeable. Petitioner asserts that it provided Resident 2 with adequate supervision and interventions to prevent accidents. Petitioner further argues that the CMP imposed was not reasonable.
As explained below, I sustain CMS’s determination that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d) because it failed to plan and implement effective fall prevention measures for Resident 2. As a result, Petitioner did not ensure for Resident 2 an environment that remains as free from accidental hazards as is possible. Additionally, I sustain CMS’s determination that Petitioner was not in substantial compliance with 42 C.F.R. § 483.10(g)(14)(i) because it failed to immediately consult with Resident 2’s physician and notify her representative following the accident. Lastly, I conclude that the CMP imposed in this matter is appropriate under relevant statutory and regulatory factors.
I. Legal Framework
The Medicare program “provides basic protection against the costs of . . . related post-hospital . . . care” for individuals over the age of 65 who are eligible for Social Security retirement benefits and for individuals under 65 who meet other criteria. 42 U.S.C. § 1395c. Post-hospital care includes extended care services provided at an SNF. 42 U.S.C. §§ 1395f(a)(2)(B), 1395x(h)-(i).
For Medicare program purposes, an SNF is an institution that is primarily engaged in providing skilled nursing care and/or rehabilitation services for its residents but is not primarily engaged in the care and treatment of mental diseases. 42 U.S.C. §§ 1395x(j), 1395i-3(a)(1). Because an SNF is a “provider of services” in the Medicare program, each SNF that participates in the program must file a provider agreement with the Secretary of Health and Human Services (Secretary). 42 U.S.C. §§ 1395cc(a), 1395x(u).
In addition to complying with the terms of the provider agreement, a participating SNF must meet a variety of ongoing statutory requirements related to how it provides services, maintains the rights of its residents, and administers its facility. 42 U.S.C. § 1395i-3(a)(3), (b)-(d). Further, SNFs must comply with “such other requirements relating to the health, safety, and well-being of residents or relating to the physical facilities thereof as the Secretary may find necessary.”1 42 U.S.C. § 1395i-3(d)(4)(B); see 42 U.S.C. § 1395i-
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3(c)(1)(xi), (f). The Secretary promulgated regulations to establish those additional requirements. See 42 C.F.R. pt. 483, subpt. B.2
When an SNF fails to meet a statutory or regulatory participation requirement, then the SNF has a “deficiency.” 42 C.F.R. § 488.301; see 42 U.S.C. § 1395i-3(h)(1). “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.” 42 C.F.R. § 488.301. To maintain “substantial compliance,” an SNF’s deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.” 42 C.F.R. § 488.301.
Broadly, noncompliance that subjects an SNF to enforcement remedies is divided into two levels. One level is comprised of deficiencies that immediately jeopardize the health or safety of residents and the other level is composed of deficiencies that do not. 42 U.S.C. § 1395i-3(h)(1). “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 Secretary has the duty to enforce the statutory and regulatory participation requirements for SNFs. 42 U.S.C. § 1395i-3(f)(1). To do so, the Secretary contracts with state agencies to conduct surveys to determine whether SNFs are in substantial compliance. 42 U.S.C. §§ 1395aa(a), 1395i-3(g); 42 C.F.R. § 488.10. Standard surveys are unannounced and occur at least once every 15 months. 42 U.S.C. § 1395i-3(g)(2)(A)(i), (iii)(I). State agencies also conduct investigations into complaints against SNFs. 42 U.S.C. § 1395i-3(g)(1)(C), (4). When the results of a survey show that an SNF is not in substantial compliance with program participation requirements, the Secretary may impose enforcement remedies on the SNF. 42 U.S.C. § 1395i-3(h)(2); 42 C.F.R. § 488.406. When CMS selects an enforcement remedy to impose on an SNF, it determines the scope (i.e., the number of residents affected or potentially affected) and severity (i.e., the degree of harm or potential harm) for each deficiency.3 See 42 C.F.R. § 488.404(a)-(b).
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One such remedy is a CMP. 42 U.S.C. § 1395i-3(h)(2)(B)(ii). CMS may impose a per‑instance CMP for each instance of the SNF’s noncompliance or a per‑day CMP for the number of days an SNF is not in substantial compliance. 42 U.S.C. § 1395i‑3(h)(2)(A), (h)(2)(B)(ii)(I); 42 C.F.R. § 488.430(a). For CMPs assessed on or after March 17, 2022, and for deficiencies that occurred after November 2, 2015, the CMP amounts may range as follows: $2,400 to $23,989 for per-instance CMPs; $120 to $7,195 per day for less serious noncompliance; or $7,317 to $23,989 per day for more serious noncompliance that poses immediate jeopardy to the health and safety of residents. 45 C.F.R. § 102.3 (2022); 87 Fed. Reg. 15,100, 15,111 (Mar. 17, 2022); see 42 C.F.R. § 488.438(a)(1) (providing original CMP amounts before statutory inflation adjustments).
If CMS imposes a CMP based on a finding of substantial noncompliance, then the SNF may request a hearing before an administrative law judge (ALJ) to challenge CMS’s initial determination of noncompliance that led to the imposition of an enforcement remedy and/or the level of noncompliance (if a successful challenge to the level would affect the range of CMP amounts imposed on the SNF). 42 U.S.C. §§ 1320a-7a(c)(2), 1395i‑3(h)(2)(B)(ii); 42 C.F.R. §§ 488.330(e)(3)(ii), 488.408(g)(1), 488.434(a)(2)(viii), 498.3(b)(13)-(14), (d)(10); see also 5 U.S.C. §§ 554, 556. However, CMS’s choice of remedies is not reviewable. 42 C.F.R. §§ 488.438(e)(2), 488.408(g)(2), 498.3(b)(13).
If an SNF challenges the existence of a deficiency, CMS must make a prima facie case that the SNF failed to substantially comply with federal participation requirements and, if such a showing is made, the SNF must then prove substantial compliance by a preponderance of the evidence. Hillman Rehab. Ctr., DAB No. 1611 at 8 (1997); see Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App’x 181 (6th Cir. 2005); Emerald Oaks, DAB No. 1800 (2001). If an SNF challenges CMS’s determination as to the level of noncompliance, CMS’s determination must be upheld unless it is clearly erroneous. 42 C.F.R. § 498.60(c)(2).
If an ALJ concludes that there was a basis for imposing a CMP on an SNF, then the SNF may dispute the amount of the CMP. The ALJ’s review of the CMP amount is limited to considering the statutory and regulatory factors for setting a CMP amount. 42 C.F.R. § 488.438(e)(3); see 42 U.S.C. §§ 1320a-7a(d), 1395i-3(h)(2)(B)(ii)(I); 42 C.F.R. § 488.438(f). The ALJ may not reduce a CMP to zero. 42 C.F.R. § 488.438(e)(1).
Either the SNF or CMS may request Departmental Appeals Board (DAB) review of an ALJ’s decision. 42 C.F.R. § 498.80.
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II. Background and Procedural History
Petitioner is a SNF that operates in Elmwood Park, Illinois. On January 13, 2022, surveyors from the IDPH completed a complaint survey relating to four complaints filed against Petitioner. CMS Ex. 1. The state agency subsequently issued a Statement of Deficiencies (SOD). Id. The SOD stated that there were no deficiencies based on three of the complaints. Id. However, the SOD indicated that the investigation into the fourth complaint yielded evidence of substantial noncompliance with 42 C.F.R. § 483.25(d)(1), (2) (Tag F689) (i.e., free of accident hazards/supervision and assistive devices to prevent accidents) at a scope and severity level “G” (i.e., isolated deficiency constituting actual harm that is not immediate jeopardy) and 42 C.F.R. § 483.10(g)(14)(i) (Tag F580) (resident rights – notification of changes) at a scope and severity level of “D” (i.e., isolated deficiency that presents no actual harm but has the potential for more than minimal harm) related to one resident (Resident 2). CMS Ex. 1. The state agency notified Petitioner on January 20, 2022, that it recommended CMS impose a denial of payment for new admissions (DPNA) effective February 4, 2022. CMS Ex. 2 at 1. The state surveyors thereafter revisited Petitioner’s facility on March 10, 2022, and determined that Petitioner had returned to substantial compliance as of January 29, 2022. Id.; see CMS Ex. 9.
Petitioner availed itself of IDPH’s Informal Dispute Resolution (IDR) process to dispute the deficiencies during the January 13, 2022 survey. See CMS Ex. 10.4 On June 24, 2022, CMS issued an initial determination that Petitioner was not in substantial compliance with Medicare participation requirements, with the most serious deficiency cited at 42 C.F.R. § 483.25(d)(1), (2). CMS Ex. 2 at 1. CMS imposed a $1,435 per-day CMP for the 19 days beginning January 10, 2022, and continuing through January 28, 2022, for a total of $27,265. Id. at 2. CMS informed Petitioner that the DPNA did not go into effect. Id. CMS also advised Petitioner that it would be ineligible to conduct a nurse aide training and competency evaluation program (NATCEP) for two years because a CMP in the amount of $11,292 or more had been imposed against it.5 Id. at 4.
On August 23, 2022, Petitioner timely requested a hearing before an ALJ. On August 25, 2022, ALJ Scott Anderson issued an acknowledgment and Standing Prehearing Order (SPO) which directed the parties to file briefs, proposed exhibits, and written direct
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testimony for all witnesses they wanted to present in this case. In compliance with the SPO, CMS filed an exchange, including a combined motion for summary judgment and prehearing brief (CMS Br.) and 18 proposed exhibits (CMS Exs. 1-18), which included written direct testimony from one proposed witness. Petitioner filed an exchange consisting of a prehearing brief and response to CMS’s motion for summary judgment (P. Br.), five proposed exhibits (P. Exs. 1‑5), and no proposed witnesses. Petitioner also filed objections to two of CMS’s proposed exhibits. CMS did not file a reply.
Effective November 5, 2024, this case was reassigned to me.
III. Admission of Exhibits into the Record
I admit Petitioner’s five proposed exhibits into the record, without objection from CMS. I also admit all of CMS’s proposed exhibits into the record. Below I explain why I overrule Petitioner’s objection to two of CMS’s exhibits.
Petitioner objected to CMS Exhibits 9 and 10. Petitioner’s Objections to CMS’s Proposed Exhibits (P. Objections). Petitioner objects to CMS Exhibit 9, which is Petitioner’s “Plan of Correction,” asserting that this document is not relevant and is neither an “admission of guilt nor . . . evidence [of] non-compliance.” Id.
In these proceedings, I am to receive into evidence any testimony and documents that are relevant and material. 42 C.F.R. § 498.60(b)(1). Further, I may receive evidence even if it is inadmissible under the rules of evidence applicable to the courts. 42 C.F.R. § 498.61. Further, the Administrative Procedure Act provides:
Any oral or documentary evidence may be received, but the agency as a matter of policy shall provide for the exclusion of irrelevant, immaterial, or unduly repetitious evidence. A sanction may not be imposed or rule or order issued except on consideration of the whole record or those parts thereof cited by a party and supported by and in accordance with the reliable, probative, and substantial evidence.
5 U.S.C. § 556(d). Therefore, the primary test for the admission of evidence is whether it is relevant and material to an issue in the case. The “Plan of Correction” is relevant and material to these proceedings as it is relevant to Petitioner’s own assessment of when it corrected its deficiencies. The document is therefore admitted. I note, however, that I do not rely on this document to establish Petitioner’s substantial noncompliance.
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Petitioner also objects to CMS Exhibit 10, which comprise the IDR/IIDR results.6 Petitioner objects that these results contain inadmissible hearsay. P. Objections. Petitioner specifically states that the “IIDR results cannot be used in adjudicating this matter as the Facility cannot examine the reviewer and further, there is no evidence that the reviewer examined the facts at hand through the same legal perspective as this tribunal.” Id. Petitioner’s claims regarding hearsay evidence, however, are misplaced. I am permitted to admit and consider hearsay statements in these administrative proceedings even if they would be inadmissible under the rules of evidence applicable to court proceedings. See 42 C.F.R. § 498.61; Florence Park Care Ctr., DAB No. 1931 (2004). The Board has recognized that hearsay statements “may be accorded appropriate weight, if supported by adequate indicia of reliability . . . .” Omni Manor Nursing Home, DAB No. 1920 at 16 (2004) (quoting Pac. Regency Arvin, DAB No. 1823 at 15 n.6 (2002)). The weight an ALJ accords hearsay is “determined by the degree of reliability, based on relevant indicia of reliability and whether the hearsay is corroborated by other evidence in the record as a whole.” Id. at 17. While I admit this document, I note that with respect to a reviewer’s opinion, the Board has stated that an “ALJ does not review CMS’s conclusions or determinations about earlier state agency-level review, but rather reviews de novo the entire record and determines whether the facility was or was not in substantial compliance with applicable regulations. See Kindred Transitional Care & Rehab - Greenfield, DAB No. 2792 (2017) (citing Britthaven of Chapel Hill, DAB No. 2284 at 4-6 (2009) (discussion in context of informal dispute resolution)).
Therefore, I overrule Petitioner’s objections and admit all of CMS’s proposed exhibits into the record.
IV. Decision on the Record
Pursuant to ALJ Anderson’s SPO, the parties were directed to submit written direct testimony for all witnesses that they wanted to testify in this proceeding. Judge Anderson’s SPO stated that an in-person hearing would only be necessary if a party requested to cross-examine a witness. SPO ¶¶ 10-12; CRD Procedures §§ 16(b), 19(b).
Petitioner did not offer any witnesses, nor did it submit written direct testimony from any witnesses. CMS submitted written direct testimony for one witness. Petitioner’s filing was ambiguous as to whether it wanted to cross-examine CMS’s witness and simply states it “reserves the right to question any and all CMS witnesses at a hearing on this matter.” Petitioner’s List of Proposed Exhibits and Witnesses. However, the SPO in this case, just like the orders issued by several other CRD ALJs, requires an explicit request
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from a party to cross-examine a witness. SPO ¶ 11. Given that Petitioner did not comply with the SPO or make an explicit request to cross-examine, I assume Petitioner did not want to do so. Therefore, I decide this case based on the written record because Petitioner did not request to cross-examine the only witness in this case.7 SPO ¶ 13; CRD Procedures § 19(d).
V. Issues
1) Whether Petitioner was in substantial compliance with the requirements of 42 C.F.R. § 483.25(d)(1), (2) (Tag F689) (scope and severity level “G”), relating to accident prevention and adequate supervision;
2) Whether Petitioner was in substantial compliance with the requirements of 42 C.F.R. § 483.10(g)(14)(i) (scope and severity level “D”), relating to notification of changes; and
3) If Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d)(1), (2) and 42 C.F.R. § 483.10(g)(14)(i), whether the $1,435 per-day CMP for the 19 days beginning January 10, 2022, and continuing through January 28, 2022, is appropriate and reasonable under applicable statutory and regulatory factors.
VI. Findings of Fact and Conclusions of Law
My findings of fact and conclusions of law are in bold and italics.
1. On January 1, 2022, Resident 2, a 101-year-old female resident, who was left unattended, suffered an unwitnessed fall from her wheelchair while dressing her lower body. As a result of her fall, Resident 2 sustained a fractured hip which required surgery. This fall occurred after Resident 2 had fallen on three previous occasions at the facility. It also happened in spite of Resident 2’s care plan for falls and documented assessment, which specified the need for assistance while Resident 2 was dressing her lower body. Moreover, following the incident, Petitioner did not immediately consult Resident 2’s physician or notify her family representative.
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Resident 2, a 101-year-old woman during the relevant time, was originally admitted to Petitioner’s facility on November 1, 2017, with multiple diagnoses including: dyskinesia of the esophagus, anemia, dysphagia, osteoarthritis, cognitive communication deficit, hearing loss of the left ear, unsteadiness on feet, muscle weakness, history of falls, fractures to the femur and spine, and other significant medical issues. CMS Ex. 3 at 1-2, CMS Ex. 6 at 1.
Upon Resident 2’s initial admission, Petitioner created a care plan with an entry that specified Petitioner was at risk for falls. CMS Ex. 5 at 1-3; see CMS Ex. 1 at 12-13. The care plan listed an intervention which instructed staff to implement an exercise program targeting strength, gait, and balance. CMS Ex. 5 at 2. On December 11, 2017, the care plan for falls was updated to include an entry for “[i]ncreased staff supervision with intensity based on [Resident 2’s] need.” CMS Ex. 5 at 2; see CMS Ex. 1 at 12-13.
Following admission, the medical records indicate that Resident 2 fell on at least three occasions: December 5, 2017, December 11, 2017, and May 6, 2019. CMS Ex. 6 at 8. On November 10, 2021, Petitioner’s staff completed a Minimum Data Set (MDS) assessment for Resident 2. CMS Ex. 4 at 1-2; CMS Ex. 1 at 8. The MDS indicated that Resident 2 used a walker and wheelchair and needed supervision and the assistance of one person while dressing. Id.
According to Resident 2’s progress notes, a late entry on January 3, 2022, documented that on January 1, 2022, Resident 2 had an unwitnessed fall in her room. CMS Ex. 6 at 17. Resident 2’s progress notes indicated that a Registered Nurse (V#19) had observed Resident 2 in her wheelchair around 9:30 a.m. that morning “getting ready for the day.” Id. Approximately 10 minutes later, Resident 2, who had been left unattended, was heard “calling for assistance and observed sitting on the floor directly in front of her wheelchair with her pants around her ankles.” Id. Resident 2 stated that “she was putting on her pants when she slid out of her chair and unto the floor.” Id. Following the fall, the Registered Nurse performed an assessment which noted that Resident 2 had no complaints of pain and no evidence of bruising, redness, or swelling. Id. Around 5:00 p.m., Resident 2 complained of pain to the buttock area, which was relieved with pain medication. Id. Around 9:03 p.m., Resident 2 complained of generalized pain which was relieved with pain medication. Id. The next afternoon, Resident 2 was observed to have swelling in her left hip and had pain while weight bearing. Id. Resident 2 was thereafter transferred to the ER for evaluation. Id. at 16-17. While at the hospital, Resident 2 was diagnosed with a broken hip on her left side and admitted on an inpatient basis. Id. at 16. On January 3, 2022, Resident 2 had surgery involving a closed reduction and nailing of the left femur.8 Id. at 15. Resident 2 was readmitted to Petitioner’s facility on January 5,
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2022. Id. During the survey, the surveyor observed Resident 2 along with a family member in Petitioner’s facility. CMS Ex. 1 at 3. The family representative stated that she had not been informed of Resident 2’s fall on the date of the incident. Id. The family member told the state surveyor that she was only notified of the incident the next day when a certified nurse aide called her and told her to come to the facility. Id. Moreover, when interviewed by the surveyor, the Registered Nurse (V#19) confirmed that she was “busy” when Resident 2 fell and did not notify either the family representative or Resident 2’s physician immediately. Id. at 4. Nor did the Registered Nurse “endorse the incident to the next shift.” Id.
2. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d)(1), (2) (Tag F689) because it did not take all reasonable steps to provide the supervision and assistance necessary to prevent Resident 2’s foreseeable accident.
The Social Security Act requires SNFs to “provide services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident, in accordance with a written plan of care.” 42 U.S.C. § 1395i-3(b)(2). In furtherance of this mandate, the Secretary promulgated the general quality of care regulation at 42 C.F.R. § 483.25, which states that the SNF “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 on a facility related to accident hazards and accidents, as follows:9
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.
Therefore, subsection 483.25(d)(1) requires that a facility address foreseeable risks of harm from accidents “by identifying and removing hazards, where possible, or, where the
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hazard is unavoidable because of other resident needs, managing the hazard by reducing the risk of accident to the extent possible.” Maine Veterans’ Home - Scarborough, DAB No. 1975 at 10 (2005) (explaining the inherent standard of care in section 483.25(h)(1)). The provisions of subsection 483.25(d) “come into play when there are conditions in a facility that pose a known or foreseeable risk of accidental harm.” Meridian Nursing Ctr., DAB No. 2265 at 10 (2009), aff’d sub nom. Fal‑Meridian, Inc. v. U.S. Dep’t of Health & Human Servs., 604 F.3d 445 (7th Cir. 2010). Further, 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”), aff’g Woodstock Care Ctr., DAB No. 1726 (2000)). 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” for a particular resident’s needs. 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).
On January 1, 2022, Resident 2 had an unwitnessed fall in her room while dressing her lower body. CMS Ex. 1 at 7; CMS Ex. 6 at 17. The next afternoon, Resident 2 was transferred to the ER where she was diagnosed with a broken hip on her left side. CMS Ex. 6 at 16-17. On January 3, 2022, she underwent a surgical procedure involving a closed reduction and nailing of the left femur. Id. at 15. Resident 2 was readmitted to Petitioner’s facility on January 5, 2022. Id. These basic facts are not in dispute.
However, the following are disputed matters that I must decide in this case:
1) Whether it was foreseeable that Resident 2 was at risk for falls while dressing; and
2) Did Petitioner provide adequate supervision to prevent Resident 2’s accident.
CMS contends that Petitioner was not in substantial compliance with the accident prevention requirements at 42 C.F.R. § 483.25(d)(1), (2) because it was foreseeable that Resident 2 could fall while dressing; nevertheless, the facility failed to create and implement a care plan to prevent such incidents. CMS Br. at 7-8. Specifically, CMS contends that the facility did not adequately supervise or assist Resident 2, despite her medical history, MDS assessment, history of falls, and knowledge that she was a fall risk while dressing. Id. at 8.
Petitioner does not dispute that Resident 2 was a “fall risk” but asserts that her fall while dressing was “unavoidable” and “unforeseeable.” P. Br. at 12-15. Moreover, Petitioner
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argues it did evaluate and analyze Resident 2’s fall risk and that CMS’s reliance on the MDS assessment to support the deficiency is misplaced because “the MDS does not reflect [Resident 2]’s day to day needs or the staff support needed for a given task, but rather is an assessment based on what actually occurred during a ‘look back period.’” Id. at 15.
As discussed below, I conclude that CMS provided sufficient evidence to meet its burden of showing a prima facie case for a deficiency (i.e., the potential for causing more than minimal harm). Hillman, DAB No. 1611 at 8. Moreover, Petitioner’s assertions are unpersuasive. The evidence shows that Petitioner failed to take all reasonable measures to adequately supervise Resident 2 to prevent her foreseeable accident while dressing. Here, Petitioner had an affirmative duty to provide Resident 2 with adequate supervision to prevent accidents. Because Petitioner failed to do so, I conclude that Petitioner did not comply substantially with 42 C.F.R. § 483.25(d).
A. Foreseeability of Resident 2’s Fall
With respect to the foreseeability of Resident 2’s fall, the record is clear that Petitioner knew that Resident 2 was at risk for falls upon her initial admission. P. Br. at 12-15, CMS Ex. 5 at 2 (care plan noting Resident 2 was at risk for falls initiated on November 2, 2017, including an intervention to “[i]mplement exercise program that targets strength, gait and balance”). In fact, Resident 2 fell on at least three occasions prior to the January 1, 2022 incident. CMS Ex. 6 at 7-8 (progress note dated 1/7/2022). Moreover, a December 11, 2017 care plan intervention highlighted the need for “[i]ncreased staff supervision with intensity based on resident need.” CMS Ex. 5 at 2.
If Petitioner needed additional reasons to be concerned with Resident 2’s risk of falling, an MDS assessment dated November 10, 2021, assessed Resident 2 as: requiring total dependence for bathing (CMS Ex. 4 at 2); not steady, and only able to stabilize with staff assistance, with walking, turning around, moving on and off the toilet, and surface to surface transfers (id.); and requiring supervision, including oversight, encouragement and cueing, along with a one-person physical assist, for activities of daily living (ADL), such as bed mobility, transfers between surfaces, walking in her room, locomotion on and off the unit, dressing, and toilet use. Id. at 1. The MDS described dressing as “how resident puts on, fastens and takes off all items of clothing . . . . Dressing includes putting on and changing pajamas and housedresses.” Id. at 3.
Further, the state surveyor’s investigation also showed that the facility’s staff knew that Resident 2 needed to be supervised when dressing to prevent a fall. CMS relies, in part,
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on the written testimony of IDPH surveyor MaMelodia Mendoza, R.N. CMS Ex. 7.10 Ms. Mendoza states that “multiple staff members at [Petitioner’s facility]” were aware that Resident 2 needed “supervision from one person for lower body dressing,” including V#2, V#14, and V#25. Id. ¶ 11. V#25, an occupational therapist, specifically stated that Resident 2 “needs supervision from one person for lower body dressing.” CMS Ex. 12 at 9; see also CMS Ex. 1 at 11 (Director of Nursing (V#2) stated in an interview that Resident 2 “does need supervision and very limited assistance during dressing.”).
Petitioner argues that the occupational therapist’s (V#25) statement to the surveyor is outdated and should be afforded minimal weight. P. Br. at 9-10. Rather, Petitioner states that a November 10, 2021 restorative assessment reveals that Resident 2 was assessed as independent for dressing both her upper and lower body and that there was no evidence of falling while dressing. Id. at 14 (citing P. Ex. 4). Notwithstanding the submission of this document, Petitioner has not submitted any written direct testimony from either the Registered Nurse that performed the restorative assessment or from any of the facility staff interviewed by the surveyor to refute the surveyor’s testimony. Moreover, the occupational therapist’s statement was corroborated by other staff including the Nurse Practitioner (V#14), who told the surveyor that Resident 2 needed staff to be present “with her for safety measures” when dressing. CMS Ex. 12 at 4. V#14 stated further that “[s]taff should be there to provide supervision and assistance during dressing.” Id. Therefore, I credit the surveyor’s statements as to what staff conveyed to the surveyor. See Beatrice State Developmental Ctr., DAB No. 2311 at 17, 18 (2010) (pointing out that the facility could have but did not present employee testimony that refuted the statements the surveyors claimed they made); Omni Manor Nursing Home, DAB No. 1920 at 11 (2004) (statements of facility employees to the surveyors may be admitted in an administrative proceeding and may constitute substantial evidence).
Based on the record evidence summarized above, it was clearly foreseeable that Resident 2 was at risk for falls. Further, Petitioner knew that Resident 2 required supervision and assistance while dressing as it presented a high risk of a fall.
B. Failure to Provide Adequate Supervision of Resident 2
According to the state surveyor, Petitioner “fail[ed] to implement a supervising program, wherein facility staff are present whenever [Resident 2] changes clothes on her lower body” and, as a result, Petitioner “breached the standard of care for supervising [Resident 2]” at the time of her fall on January 1, 2022. CMS Ex. 7 ¶ 12. Therefore, from CMS’s perspective, in discussing the adequacy of supervision, the focus must be on the absence of supervision while dressing.
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Petitioner disputes that supervision while dressing was required. P. Br. at 13-15. Rather, Petitioner asserts that it was aware of Resident 2’s fall risk, implemented a care plan, there was no evidence Resident 2 had ever fallen while dressing, and that Resident 2 had not fallen for almost 2.5 years. Id. at 14. Moreover, Petitioner disputes that additional supervision during dressing was required in this case based on the MDS. Id. Petitioner argues that her assessments properly analyzed her risk and that the MDS should be given less weight. Id.
In support of CMS’s position, Ms. Mendoza testified regarding Petitioner’s knowledge of Resident 2’s fall risk and need for supervision while dressing. CMS Ex. 7 ¶ 8. Specifically, Ms. Mendoza stated:
The facility recorded multiple instances of R2 falling, and her medical records indicated that she needed “oversight, encouragement or cueing” and a “one person physical assist” when “putting on and changing pajamas and housedresses.” Medical records further noted that R2 “is impulsive and impatient. Resident claimed she wants to do on her own, disregard safety.”
Id. (internal citations omitted). Ms. Mendoza further stated that Petitioner’s MDS assessment specified that Resident 2 required staff supervision when dressing:
Specifically, R2’s MDS dated November 10, 2021, stated that R2 needed supervision from one staff while changing the clothes on the lower part of her body.
Id. at ¶ 11 (internal citations omitted). Notwithstanding Petitioner’s knowledge of Resident 2’s fall risk while dressing, CMS asserts that facility staff failed to implement new interventions following the MDS. CMS Br. at 7-8. As an intervention, CMS posits that increased assistance should have been provided. As testified to by Ms. Mendoza:
The standard of care for a long-term care resident, such as R2, who experiences difficulty changing her clothes without assistance, due to physical impairment, is to supervise her when she changes her clothes and be ready to assist her in the event she needs it. This involves determining a resident’s morning routine and scheduling facility staff to routinely supervise and assist them when it is time to change their clothes. This would reduce incidents, such as R2’s January 1, 2022 fall.
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CMS Ex. 7 ¶ 11. Lastly, I accept the testimony of the state surveyor that had Resident 2 been supervised, she might not have fallen and sustained injury. CMS Ex. 7 ¶ 13. Specifically, Ms. Mendoza stated that:
By failing to implement a supervising program, wherein facility staff are present whenever R2 changes the clothes on her lower body as noted in R2’s MDS, [Petitioner] breached the standard of care for supervising R2 on January 1, 2022, and R2 fell.
CMS Ex. 7 ¶ 12. Petitioner argues that it had a fall prevention care plan in place and supervision while dressing was not required. P. Br. at 13-14. With respect to the January 1, 2022 fall, Petitioner contends that it was an “unavoidable accident” and that the “facility assessed [Resident 2’s] need for assistance with ADLs and risk for falls, developed a plan of care to address [Resident 2’s] needs and provided the appropriate level of supervision.” Id. at 14-15. Notwithstanding these arguments, Petitioner has not put forth any evidence rebutting the surveyor’s testimony.
Moreover, I agree with CMS that Petitioner’s noncompliance stems from its failure to effectively plan and implement precautions to reduce the hazard of falls as much as possible. See Buena Vista Care Ctr., DAB No. 2498 at 15-16 (2013) (upholding a finding of non-compliance under 42 C.F.R. § 483.25(h) (i.e., the predecessor to § 483.25(d)) where a resident’s care plan failed to contain any interventions addressing how to protect a seizure-prone resident.). While increased supervision and monitoring of Resident 2 may have been a useful intervention (care plan entry dated December 11, 2017, CMS Ex. 5 at 2), Petitioner has submitted no evidence that this was performed. Further, the occupational therapy (OT) records submitted by Petitioner do not aid its own argument. Specifically, Petitioner submitted Resident 2’s OT discharge summary dated September 14, 2021. P. Ex. 5. These notes indicate that OT interventions began on July 20, 2021, in part, to support Resident 2 with safely dressing her lower body. Id. At the time OT began, Resident 2’s baseline ability was dressing her lower body with moderate assistance while sitting. Id. at 1. While Resident 2 improved with therapy, at the time of her discharge from OT on September 14, 2021, the notes still revealed that Resident 2 needed supervision for lower body dressing. Id. at 2. I further note that despite these records indicating a need for supervision while dressing, there is no corresponding update to Resident 2’s care plan. See CMS Ex. 5.
Petitioner also argues that CMS improperly relied upon the MDS assessment to support its allegations of noncompliance. P. Br. at 15. Specifically, Petitioner contends that the MDS does not reflect Resident 2’s actual daily needs but is only an assessment based on a “look-back period.” Id. I am unpersuaded by this argument. As stated above, Petitioner was obligated to “provide services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident, in accordance with a
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written plan of care.” 42 U.S.C. § 1395i-3(b)(2); see 42 C.F.R. § 483.25. The care plan must be periodically reviewed and revised by an SNF’s interdisciplinary team following MDS assessments. 42 U.S.C. § 1395i-3(b)(2)(C), (b)(3); see 42 C.F.R. § 483.20(d). In light of the statutory and regulatory significance placed on the MDS and its role in developing resident care plans, Petitioner is hard-pressed to explain that the MDS does not necessarily reflect the actual level of care required because it is an assessment based solely on a “look-back period.” P. Br. at 15. The MDS is derived from a comprehensive evaluation and is more than a snapshot, which is why both the Act and its implementing regulations require facilities who wish to participate in the Medicare program to incorporate treatments or interventions based on the MDS into a resident’s care plan. 42 U.S.C. § 1395i–3(b)(3)(A); 42 C.F.R. § 483.20; 42 C.F.R. § 483.21(b)(2). Moreover, Petitioner appears to be arguing that it can simply rely on a care plan that was not updated – in violation of the regulations.11
For these reasons, I reject Petitioner’s claim that it was unreasonable for CMS to rely upon the MDS. The staff knew that supervision while dressing was a necessary intervention to protect Resident 2 from falls notwithstanding what the care plan stated. The failure to provide supervision and assistance while Resident 2 was dressing her lower body, resulting in her fall, was inadequate supervision.
I sustain CMS’s determination that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d). Resident 2’s fall was foreseeable, and Petitioner failed to adequately supervise Resident 2 to prevent her accident.
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3. Petitioner was not in substantial compliance with 42 C.F.R. 483.10(g)(14)(i) (Tag F580) because it did not immediately consult Resident 2’s physician and notify her family representative following her fall.12
42 C.F.R. § 483.10(g)(14)(i) requires a facility to “immediately inform the resident; consult with the resident’s physician; and notify, consistent with his or her authority, the resident representative(s), when there is –” (among other events): an accident involving the resident resulting in injury with the potential for requiring physician involvement; 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); or the need to alter treatment significantly.
Petitioner has a policy titled “Change in a Resident’s Condition or Status.” CMS Ex. 14. This policy describes the procedures for when a nurse should notify a resident’s attending physician. Id. The policy includes that when a “significant change in the resident’s physical . . . status” occurs, the nurse should notify the attending physician. Id. at 1. Petitioner also has a policy titled “Fall Reduction Program.” CMS Ex. 15.13 The policy states, “[i]n the event a fall incident occurs, nursing staff will complete an assessment of resident and obtain the facts surrounding the fall, and report findings to the resident’s physician and responsible party (if applicable) and document findings and notification within the resident’s clinical record.” Id. at 2.
CMS contends Petitioner did not substantially comply with 42 C.F. R. § 483.10(g)(14)(i) when it failed to immediately consult with Resident 2’s physician and notify her representative of the accident. CMS Br. at 9-10. The parties do not dispute the underlying facts of this purported violation. Rather, Petitioner argues that “the facts alleged . . . does [sic] not warrant a CMP at all.” P. Br. at 16.
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The undisputed facts show that following Resident 2’s fall, her representative was not notified until the following day. CMS Ex. 1 at 3. Moreover, when interviewed by the surveyor, the Registered Nurse (V#19) confirmed that she was “busy” and did not notify Resident 2’s physician or her family member. Id. at 4. Nor did she “endorse the incident to the next shift.” Id. Additionally, the state surveyor found no documentation which indicated that the nurse practitioner, Resident 2’s physician, and Resident 2’s family member were notified at the time Resident 2’s fall occurred. Id. at 5.
Given these undisputed facts, Petitioner failed to substantially comply with 42 C.F.R. § 483.10(g)(14)(i). The regulation requires a facility to immediately consult with the resident’s physician and notify the resident’s representative following an accident resulting in an injury with the potential for physician involvement or where there is a significant change in the resident’s physical status.
4. The CMP amount imposed, $1,435 per-day from January 10, 2022, through January 28, 2022, is reasonable.
In determining whether the CMP amount is reasonable, I must apply the following factors which are listed in 42 C.F.R. § 488.438(f): 1) the facility’s history of noncompliance, including repeated deficiencies; 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. See 42 U.S.C. §§ 1320a-7a(d)(2), 1395i-3(h)(2)(B)(ii)(I). The absence of culpability is not a mitigating factor. 42 C.F.R. § 488.438(f)(4). 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. See 42 U.S.C. §§ 1320a-7a(d)(1), (3), 1395i-3(h)(2)(B)(ii)(I).
The regulations leave the choice of remedy to CMS, and the amount of the remedy to CMS and the ALJ, requiring only that the regulatory factors at 42 C.F.R. §§ 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). The Board has explained that “there is a presumption that CMS has considered the regulatory factors in setting the amount of the CMP and that those factors support the CMP amount imposed by CMS. Unless a facility contends that a particular regulatory factor does not support that CMP amount, the ALJ must sustain it.” Coquina Ctr., DAB No. 1860 at 32 (2002). The burden is on the facility to demonstrate that a reduction is necessary to make the CMP amount reasonable. Heritage Plaza Nursing Ctr., DAB No. 2829 at 22 (2017).
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In assessing the reasonableness of a CMP amount, an ALJ considers the per-day amount, rather than the total accrued CMP. See Kenton, 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 (2010). 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); 87 Fed. Reg. 15,100, 15,111.
Here, CMS imposed a CMP of $1,435 per day from January 10, 2022, through January 28, 2022, which is reasonable. CMS Ex. 2 at 2. The $1,435 amount is at the lower end of the penalty range. The evidence shows that CMS “considered [Petitioner’s] history, including any repeated deficiencies, its financial condition, and the factors specified in . . . 42 C.F.R. § 488.404.” Id.
Petitioner argues that the total amount of the CMP is unreasonable because the facts fail to demonstrate any noncompliance. P. Br. at 16. However, I have determined that the facts before me support a finding of substantial noncompliance. Thus, the issue before me is whether the regulatory factors were considered in setting the CMP amount and whether those factors support the CMP amount. 42 C.F.R. §§ 488.438(f), 488.404. Petitioner does not allege that a particular regulatory factor does not support the CMP amount. See P. Br.
Considering the factors, Petitioner’s noncompliance was very serious. Petitioner’s failure to adequately supervise Resident 2 resulted in a serious injury, for which Petitioner is culpable. Petitioner’s culpability is also significant as it failed to consult with Resident 2’s physician or her representative immediately following the incident. Additionally, CMS has presented evidence of Petitioner’s noncompliance history and claims that Petitioner has a “substantial history of noncompliance.” CMS Br. at 11 (citing CMS Ex. 11).
Petitioner has not offered any argument or rebuttal to CMS’s evidence showing its history of noncompliance, nor has it made any argument that it cannot pay the $1,435 per-day CMP. I thus find no basis to reduce the CMP. As a result, considering the regulatory factors here, I conclude that the CMP amount imposed is reasonable.
Because I sustain the CMP, which is over the $11,995 threshold amount to trigger the NATCEP prohibition, I must also sustain the prohibition against conducting a NATCEP for 2 years. Act § 1819(f)(2)(B); 42 C.F.R. § 483.151(b), (f); 87 Fed. Reg. 15,100, 15,120.
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VII. Conclusion
For the reasons set forth above, I sustain CMS’s determination that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d)(1), (2) and 42 C.F.R. 483.10(g)(14)(i) and that a $1,435 per-day CMP from January 10, 2022 through January 28, 2022, is fully supported by the relevant statutory and regulatory factors in this case.
Benjamin J. Zeitlin Administrative Law Judge
- 1
“It is the duty and responsibility of the Secretary to assure that requirements which govern the provision of care in skilled nursing facilities . . . are adequate to protect the health, safety, welfare, and rights of residents and to promote the effective and efficient use of public moneys.” 42 U.S.C. § 1395i-3(f)(1).
- 2
All citations to the Code of Federal Regulations are to the version in effect at the time of the survey unless otherwise indicated.
- 3
CMS or the state agency designates the scope and severity level using a letter from A through L based on a scope and severity matrix published in the State Operations Manual, Ch. 7, § 7400.3.1 (Rev. 185, eff. Nov. 16, 2018). Levels A, B, and C indicate a deficiency that presents no actual harm but has the potential for minimal harm, which means the facility technically remains in substantial compliance. CMS cannot impose enforcement remedies for scope and severity levels A, B, or C. 42 C.F.R. § 488.301. Levels D, E, and F indicate a deficiency that presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy. Levels G, H, and I indicate a deficiency that involves actual harm that does not amount to immediate jeopardy. Finally, levels J, K, and L indicate a deficiency that constitutes immediate jeopardy to resident health or safety.
- 4
Petitioner also appears to have requested Independent Informal Dispute Resolution (IIDR) on June 30, 2022. See CMS Ex. 10 at 3-5.
- 5
I note that the notice letter states that the NATCEP prohibition applies when a CMP of not less than $11,292 is assessed. CMS Ex. 2 at 4. However, because the notice letter was sent after March 17, 2022, the adjusted civil monetary penalty amount on the NATCEP threshold appears to be $11,995 rather than $11,292. 45 C.F.R. § 102.3; see 87 Fed. Reg. 15,100, 15,120 (March 17, 2022).
- 6
As noted above, Petitioner appears to have requested both IDR and IIDR. See CMS Ex. 10. Moreover, while CMS’s Exhibit List describes CMS Exhibit 10 as the “IIDR Results,” based on my review of the exhibit, this document seems to comprise results for both IDR and IIDR. See CMS Ex. 10; see also CMS Exhibit List.
- 7
Other CRD ALJs have noted Petitioner’s counsel’s familiarity with this requirement from past cases and interpreted counsel’s vague request concerning cross-examination as an effort to evade the valid purpose of these orders. See, e.g.,Generations at Elmwood Park, DAB CR6227 at 7 n.3 (2023) (“Counsel is placed on notice that future use of vague or ambiguous language concerning a request to cross-examine witnesses will result in waiver of the right to cross-examine those witnesses.”).
- 8
The progress notes incorrectly state that Resident 2’s surgical procedure took place on January 3, 2021, rather than January 3, 2022. CMS Ex. 6 at 17.
- 9
CMS revised part 483 regulations concerning SNF conditions of participation in 2016, including the quality-of-care regulation found at 42 C.F.R. § 483.25. 81 Fed. Reg. 68,688 (Oct. 4, 2016); 82 Fed. Reg. 32,256 (July 13, 2017) (technical corrections). The accident prevention regulation currently promulgated in 42 C.F.R. § 483.25(d) was formerly found in 42 C.F.R. § 483.25(h). In assessing compliance under section 483.25(d) in this case, I consider case decisions analyzing the former section 483.25(h).
- 10
Surveyor Mendoza’s Declaration is listed as CMS Exhibit 7 on CMS’s Exhibit List. However, the pages of the exhibit are incorrectly labeled as CMS Ex. 5. For clarity, references to CMS Exhibit 7 in this decision refer to Surveyor Mendoza’s Declaration.
- 11
An evaluation more recent than a MDS assessment can lead a facility to vary from what is set forth in the MDS assessment, if warranted. Indeed, facilities must update their approach to patient care in such a case. Harmony Court, DAB No. 1968 at 4 (2005) (“[C]are provided to residents [in] accord with their assessments and care plans does not limit a facility’s duty to provide quality care to addressing needs spelled out in a resident’s formal comprehensive assessment where other needs become evident after that assessment.”) (citations omitted).
- 12
In its brief, CMS states that the CMP was issued based on Petitioner’s noncompliance with both Tag F689 and Tag F580. CMS Br. at 1. However, Petitioner asserts that the CMP “was not issued due to the alleged non-compliance at F580, nor would that citation at F580 support the imposed CMP.” P. Br. at 2. In support of its position, Petitioner relies on CMS’s notice letter dated June 24, 2022. CMS Ex. 2. While I agree with Petitioner that the notice letter only mentions Tag F689, this document lists only the “most serious deficiency” and otherwise incorporates the other deficiencies listed in the SOD, including Tag F580. CMS Ex. 2 at 1; see CMS Ex. 1.
- 13
CMS listed Petitioner’s “Fall Reduction Program” policy as CMS Ex. 15 on its exhibit list. However, the pages of the exhibit are incorrectly labeled as CMS Ex. 1. For clarity, references to CMS Ex. 15 in this decision are to the document entitled “Fall Reduction Program.”