Vista Manor Nursing Center, DAB CR5731 (2020)

DECISION

Vista Manor Nursing Center (Vista Manor or Petitioner) challenges the determination by the Centers for Medicare & Medicaid Services (CMS) that it was not in substantial compliance with Medicare program participation requirements.  Vista Manor also challenges CMS’s imposition of a $15,000 civil money penalty (CMP) as unreasonable. As explained herein, I conclude that Petitioner did not substantially comply with the Medicare participation requirement at 42 C.F.R. § 483.25(d) and find the CMP amount reasonable.

I.  Background

Vista Manor is a skilled nursing facility (SNF) located in San Jose, California that participates in the Medicare program.  CMS Exhibit (Ex.) 1 at 1.  Surveyors from the California Department of Public Health (CDPH or state agency) completed a recertification survey at Petitioner’s facility from November 13 through November 16,

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2017.  Id.  CDPH found the facility was not in substantial compliance with seven Medicare program requirements: 

42 C.F.R. § 483.10(c)(7) (Tag F176);
42 C.F.R. § 483.10(e)(1) (Tag F221);
42 C.F.R. § 483.21(b)(3) (Tag F281);
42 C.F.R. § 483.25(d) (Tag F323);
42 C.F.R. § 483.60(i) (Tag F371);
42 C.F.R. § 483.45 (Tag F431); and
42 C.F.R. § 483.90(d)(2), (e) (Tag F456).1

CMS Ex. 1. 

On December 6, 2017, CMS notified Petitioner it found the facility to be non-compliant, relying on the state agency’s recommendations.  CMS Ex. 2 at 1.  CMS advised Petitioner that based on its noncompliance with 42 C.F.R. § 483.25(d) (Tag F323),2 CMS would impose a per-instance CMP of $15,000.  Id. at 2.  CMS further notified Petitioner that it would impose a denial of payment for new admissions (DPNA), effective February 16, 2018, if Petitioner did not return to substantial compliance by that date.  Id. at 2-3.  Lastly, CMS asserted that by operation of regulation, it would deny Petitioner approval of any nurse aide training program.  Id. at 3. 

CDPH returned to the facility on January 3, 2018 to conduct a revisit survey and concluded Petitioner had returned to substantial compliance with CMS’s conditions of

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participation.  CMS Ex. 1 at 1.  CMS accepted the state agency’s findings and notified Petitioner it rescinded the DPNA.  CMS Ex. 3. 

On January 31, 2018, Petitioner timely sought hearing before an administrative law judge (ALJ) to challenge CMS’s determination of noncompliance with program requirements and the imposition of the $15,000 per-instance CMP.  I was designated to hear and decide this case and issued an Acknowledgment and Pre-hearing Order (Pre-hearing order) that established a briefing schedule and directed the parties to file pre-hearing submissions that included written direct testimony for all proposed witnesses, proposed exhibits, and pre-hearing briefs. 

CMS filed a pre-hearing brief (CMS Br.) and 40 proposed exhibits (CMS Exs. 1-40), which included written direct testimony for five witnesses.  Petitioner filed a pre-hearing brief (P. Br.) and five exhibits (P. Exs. 1-5), which included the written direct testimony of one witness.  Both parties requested to cross-examine the opposing parties’ witnesses.  CMS objected to P. Exs. 1 through 3 as irrelevant.

On November 1, 2018, the parties filed a joint motion waiving their requests for an in-person hearing and asking me to decide this case on the written record.  The parties also sought leave for Petitioner to submit briefing in response to CMS’s objections and for both parties to file closing briefs following my ruling on CMS’s objections. 

I granted the parties’ request to cancel the hearing and decide this matter on the record, set a briefing schedule for the submission of closing briefs, and denied the parties’ request to grant Petitioner leave to file an untimely response to CMS’s objections, as they had failed to articulate good cause for Petitioner’s failure to object within the time permitted by my Pre-hearing order.  The parties timely submitted closing briefs (CMS Closing Br. and P. Closing Br., respectively). 

II.    Scope of Decision

As an initial matter, Petitioner is not entitled to a review of CMS’s determination that it was not in substantial compliance with 42 C.F.R. §§ 483.10(c)(7) (Tag F176), 483.10(e)(1) (Tag F221), 483.21(b)(3) (Tag F281), 483.60(i) (Tag F371), 483.45 (Tag F431), and 483.90(d)(2), (e) (Tag F456) because CMS did not impose remedies based on those deficiencies.  By regulation, a SNF has a right to a hearing before an ALJ where CMS has issued an “initial determination” of a kind specified in 42 C.F.R. § 498.3(b).  But it is only after CMS makes a finding of noncompliance and imposes a remedy under 42 C.F.R. § 488.406 that a SNF receives an “initial determination” subject to further review.3  Columbus Park Nursing & Rehab. Ctr., DAB No. 2316 at 6 (2010), dism. on

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other grounds, Columbus Park Nursing & Rehab. Ctr. v. Sebelius, 940 F. Supp. 2d 805 (N.D. Ill. 2013); see also 42 C.F.R. §§ 488.406, 498.3(b). 

As the Board observed, a SNF “has no right to an [administrative law judge] hearing to contest survey deficiency findings where CMS has not imposed any of the remedies specified in section 488.406 based on those findings . . . .”  Columbus Park, DAB No. 2316 at 7.  The imposition of a remedy, not the citation of a deficiency, triggers the right to a hearing.  Schowalter Villa, DAB No. 1688 (1999); Arcadia Acres, Inc., DAB No. 1607 (1997).  Accordingly, where CMS finds a deficiency but does not impose a remedy, Petitioner has no right to a hearing.  Fountain Lake Health & Rehab., Inc., DAB No. 1985 (2005).

Petitioner nevertheless asserts that “[w]here CMS imposes a penalty that is based on only a subset of the deficiencies that are subject to a finding of noncompliance, the tribunal must nonetheless review all deficiencies.”  P. Br. at 3, citing Plott Nursing Home v. Burwell, 779 F.3d 975 (9th Cir. 2015).4  In Plott, CMS cited the facility with 33 deficiencies and imposed a per-day CMP for the period of time the facility had been out of compliance with the cited Medicare regulations.  779 F.3dat 979-80.  Both the ALJ and the Departmental Appeals Board (Board) upheld the imposed CMP based on review of only three of the cited deficiencies, finding review of the remaining deficiencies immaterial because the CMP was reasonable based solely on the three reviewed deficiencies.  Id.  The Ninth Circuit remanded the matter for review of all 33 deficiencies, reasoning that the statute required review of all alleged deficiencies because they could affect future penalties.  Id. at 988. 

Petitioner’s reliance on Plott is misplaced.  That case considered the materiality of unreviewed deficiencies to the application of a per-day CMP.  The Ninth Circuit did not reject the Board’s conclusion that immaterial deficiencies need not be reviewed; instead, it determined that the unreviewed deficiencies in that case were indeed material:

The Board’s reasoning for not reviewing any other deficiencies is basically that the $500 per day penalty could have been imposed for the remaining two September deficiencies, so the unreviewed surveyor’s allegations were “immaterial.”  We cannot agree.  Unreviewed allegations of deficiency do indeed affect penalties, as the Board decision demonstrates in this case.  And the Board's position that, so long as the penalty is within the maximum permitted, more deficiencies are immaterial, does not make sense.

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Penalties may be higher or lower within an authorized range, depending on the extent of deficiencies.

Plott, 779 F.3d at 985-86.

Here, by contrast, CMS made clear that it relied solely on the deficiency arising under 42 C.F.R. § 483.25(d) (Tag F323) to calculate and levy a per-instance penalty against Petitioner.  CMS Ex. 2 at 2.  The remaining deficiencies played no role in CMS’s calculation of the per-instance5 penalty it imposed and therefore continue to fail to trigger a right to appeal under the controlling regulations.

The Plott decision also reflects the Ninth Circuit’s concern that unpenalized deficiencies could be used in future proceedings to increase a CMP levied against a facility.  779 F.3d at 988.  The Court of Appeals observed the Board had relied on the Act’s requirement to require “incrementally more severe fines for repeated . . . deficiencies.”  Id., citing 42 U.S.C. § 1395i-3(h)(2)(B).  But CMS does not interpret the Act to require increased penalties for all past noncompliance.  The regulations instead specify that CMS or a state agency will “increase the per day penalty amount for any repeated deficiencies for which a lower level penalty amount was previously imposed . . .”  42 C.F.R. § 488.438(d)(2) (emphasis added); see also SOM, Ch. 7 § 7516.3.3 (defining “Repeated Deficiencies” as “deficiencies found at the last . . . survey for which a civil money penalty was imposed and sustained . . .”) (emphasis added).  In its regulations and guidance, CMS has therefore precluded the possibility of using past instances of noncompliance to increase deficiencies unless those past instances were penalized.  The circumstances in Plott are therefore readily distinguishable and do not appear to apply here. 

Broad application of Plott is otherwise inappropriate because the Ninth Circuit never addressed the obvious jurisdictional problem that would arise by applying its directive to review any deficiency cited by CMS even where it did not result in imposition of a penalty.  As I have discussed, the regulations clearly limit my authority to review deficiencies to those for which CMS has imposed a penalty of some kind.  Applying Plott’s holding to require review of all cited deficiencies, regardless of the degree to which they were relied upon by CMS to calculate a penalty, would by operation invalidate the regulations I have discussed, as well as expand subject-matter jurisdiction

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conferred by the Act on myself, the Board, and ultimately, the federal district and appellate courts reviewing these matters on appeal.  It is unlikely the Ninth Circuit intended its holding to override Congress’s jurisdictional grant or overturn the Secretary’s regulatory scheme absent express language to that effect. 

Ultimately, I am bound to follow the Act and regulations.  1866ICPayday.com, L.L.C., DAB No. 2289 at 14 (2009).  Because the Ninth Circuit did not expressly invalidate the regulatory scheme that sets forth my jurisdiction, I am still bound to apply those regulations here.  42 C.F.R. § 498.3(b)(13) makes plain that CMS makes initial determinations with respect to “the finding of noncompliance leading to the imposition of enforcement actions.”  The only initial determination properly before me is CMS’s finding that Petitioner violated 42 C.F.R. § 483.25(d), because only that instance of alleged noncompliance led to the imposition of enforcement remedies.  For this reason, Petitioner has no right to administrative law judge review of the findings of noncompliance cited under 42 C.F.R. §§ 483.10(c)(7) (Tag F176), 483.10(e)(1) (Tag F221), 483.21(b)(3) (Tag F281), 483.60(i) (Tag F371), 483.45 (Tag F431), and 483.90(d)(2), (e) (Tag F456).

III.  Issues

The issues presented are:

1. Whether Petitioner was in substantial compliance with the Medicare participation requirement obligations imposed by 42 C.F.R. § 483.25(d) (Tag F323).
2. If Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d), whether the remedies imposed are reasonable.

IV.  Admission of Exhibits

There being no objection from Petitioner, I admit CMS Exs. 1-40 into the record.

Petitioner filed five exhibits.  CMS objected to P. Exs. 1-3, arguing the “evidence in the record is insufficient to demonstrate that the medication profiles in Petitioner’s Exhibits 1-3 are for the medications relevant to the cited F176 deficiency.”  Petitioner filed no response to these objections.

I sustain CMS’s objection to P. Exs. 1-3.  The regulations require evidence submitted to me be relevant and material.  42 C.F.R. § 498.60(b)(1).  As discussed above, Petitioner does not have a right to hearing for the deficiency at 42 C.F.R. § 483.10(c)(7) (Tag F176) because CMS did not impose a remedy based on Petitioner’s noncompliance with that

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program requirement.  P. Exs. 1-3 do not pertain to the deficiency at issue before me and are therefore irrelevant and excluded from the record.  P. Exs. 4-5 are admitted.

V.  Jurisdiction

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

VI.  Statutory and Regulatory Background

The Social Security Act (Act) sets forth requirements for a SNF’s participation in the Medicare program and authorizes the Secretary of Health and Human Services to promulgate regulations implementing those statutory provisions.  42 U.S.C. § 1395i-3.  These implementing 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 participation requirements.  To be in substantial compliance, a 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.  A deficiency is a violation of a participation requirement established by 42 U.S.C. § 1395i-3(b)-(d), or the Secretary’s regulations at 42 C.F.R. pt. 483, subpt. B.  Id.  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  Id.

The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with the participation requirements.  42 U.S.C. § 1395aa(a); 42 C.F.R. § 488.10.  The Act also authorizes the Secretary to impose enforcement remedies against SNFs that are not in substantial compliance with the program participation requirements.  42 U.S.C. § 1395i-3(h)(2).  The regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance.  42 C.F.R. § 488.406. 

Among other enforcement remedies, CMS may impose a per-instance CMP for each instance of the SNF’s noncompliance.  42 C.F.R. § 488.430(a).  The regulations specify that the per-instance CMP will be in the range of $2,097 - $20,965, for each instance of noncompliance.6  42 C.F.R. § 488.438(a)(2); 45 C.F.R. § 102.3.  When CMS elects to impose a CMP, it sets the CMP amount based on, among other factors, the “seriousness” of the noncompliance.  42 C.F.R. §§ 488.404(a), (b), 488.438(f).  Seriousness is a function of the noncompliance’s scope (whether it is “isolated,” constitutes a “pattern,” or

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is “widespread”) and severity (whether it has created a “potential for” harm, resulted in “[a]ctual harm,” or placed residents in “immediate jeopardy”).  42 C.F.R. § 488.404(b).  If CMS imposes a CMP based on a noncompliance determination, 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.  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.  42 C.F.R. § 488.408(g)(2).

CMS has the burden to come forward with evidence sufficient to make a prima facie showing that Petitioner is out of substantial compliance with participation requirements to establish a basis to impose an enforcement remedy.  See, e.g., Evergreene Nursing Care Ctr., DAB No. 2069 at 7 (2007).  If CMS makes this prima facie showing, then Petitioner bears the ultimate burden of persuasion as to whether it substantially complied.  In other words, Petitioner must show, by a preponderance of the evidence of record that it was in substantial compliance with participation requirements.  Id.  Petitioner has both the burden of coming forward and the burden of persuasion as to any affirmative defense.  Id.; Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004), aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App’x 181 (6th Cir. 2005).

VII.  Statement of Facts

Resident 3, a 72-year-old woman at the time of the incident, was admitted to Petitioner’s facility on December 1, 2016.  CMS Ex. 9 at 20.  Resident 3’s diagnoses upon admission included osteoporosis, diabetes mellitus, hydrocephalus, hypertension, and depression.  CMS Ex. 9 at 20, 42-43; CMS Ex. 38 at 8.  While Resident 3 was deemed cognitively alert with a Brief Interview for Mental Status (BIM) score of 13, she was also found to be totally dependent on staff for toilet use, including changes of incontinence pads, and required the assistance of two or more staff members for activities involving toilet use.  CMS Ex. 9 at 27, 35.  Resident 3 was similarly evaluated to be totally dependent and requiring the assistance of two or more staff members for bed mobility, including moving from lying position and turning to side, and dressing.  CMS Ex. 9 at 35.  Approximately one week prior to the incident, Resident 3 was assessed as requiring the assistance of one person for toilet use and two-person assistance for bed mobility.  CMS Ex. 4 at 27.

Petitioner also conducted a fall-risk assessment for Resident 3 on admission.  She was assessed a total risk score of 13, indicating a high risk for falling.  CMS Ex. 4 at 28.  Resident 3’s care plan on admission in December 2016 reflected she was totally dependent on staff for many activities of daily living.  CMS Ex. 9 at 79.  It similarly indicated that Resident 3 required the assistance of two staff members to change positions in bed, dress, and use the toilet.  CMS Ex. 4 at 12; CMS Ex. 9 at 79; CMS Ex. 38 at 8.  The facility documented that Resident 3 had impaired balance during transitions and was at risk for fall and injury due to her condition.  CMS Ex. 9 at 63-64.

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On the evening of March 16, 2017, a Certified Nursing Assistant (CNA) identified in the record only as “CNA Lucy”7 went to Resident 3’s room to change her incontinence pad while she was in bed.  CMS Ex. 9 at 11-16; CMS Ex. 38 at 9.  Although Resident 3’s care plan specified two-person assistance for toileting and bed mobility, the CNA did not ask any other staff member for assistance, believing them to be busy.  CMS Ex. 9 at 11-16, 79; CMS Ex. 38 at 9.  CNA Lucy turned Resident 3 on her side to assist in changing her, and Resident 3 began to slide out of her bed.  CMS Ex. 38 at 9.  CNA Lucy’s attempts to halt Resident 3’s fall out of bed were unsuccessful, so to minimize potential injury, she instead attempted to guide Resident 3 to the floor.  Once Resident 3 was on the ground, CNA Lucy sought assistance to return Resident 3 to bed.  CMS Ex. 9 at 11-16; CMS Ex. 38 at 9.

After the fall, Resident 3 complained of right leg pain.  CMS Ex. 9 at 99; CMS Ex. 38 at 9.  X-ray imaging performed the next day revealed Resident 3 had sustained a relatively acute angulated and moderately displaced supracondylar fracture to her right femur.  CMS Ex. 9 at 110-11.  On March 18, 2017, Resident 3 was transferred to a hospital for treatment of the fracture.  CMS Ex. 9 at 102. 

VIII.  Discussion8

A.    Applicable Law

Subsection 483.25(d) is part of the quality of care regulations at 42 C.F.R. § 483.25, and requires a facility to “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.”  42 C.F.R. § 483.25(d) imposes specific obligations upon a facility related to accident hazards and accidents:

The facility must ensure that –

(1) The resident environment remains as free of accident hazards as is possible; and

(2) Each resident receives adequate supervision and assistance devices to prevent accidents.

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The Board has held that 42 C.F.R. § 483.25(d)(1) requires a facility to address foreseeable risks of harm from accidents “by identifying and removing hazards, where possible, or where the hazard is unavoidable because of other resident needs, managing the hazard by reducing the risk of accident to the extent possible.”  Meadowwood Nursing Ctr., DAB No. 2541 at 2 (2013) (citing Maine Veterans’ Home – Scarborough, DAB No. 1975 at 10 (2005)). 

Meanwhile, 42 C.F.R. § 483.25(d)(2) requires a facility to take “all reasonable steps to ensure that a resident receives supervision and assistance devices that meet his or her assessed needs and mitigate foreseeable risks of harm from accidents.”  Briarwood Nursing Ctr., DAB No. 2115 at 11 (2007) (citing Woodstock Care Ctr. v. Thompson, 363 F.3d 583, 590 (6th Cir. 2003) (facility must take “all reasonable precautions against residents’ accidents”)). 

Facilities are given “the flexibility to choose the methods” to provide supervision or assistive devices to prevent accidents, so long as the chosen methods “constitute an ‘adequate’ level of supervision under all circumstances.”  Windsor Health Care Ctr., DAB No. 1902 at 5 (2003), aff’d, Windsor Health Care Ctr. v. Leavitt, 127 F. App’x 843 (6th Cir. 2005) (unpublished).  However, facilities are expected to:  identify, evaluate, and analyze hazards and risks; implement interventions to reduce hazards and risks; and monitor the effectiveness of interventions and modify them when necessary.  SOM, CMS Pub. 100-07, App. PP – Guidance to Surveyors for Long Term Care Facilities. 

B.    Analysis

1.  Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d) because Petitioner’s staff failed to provide an environment as free as possible from accident hazards, and failed to provide safe and appropriate transfers, resulting in an accidental fracture to Resident 3’s femur.

There is no dispute between the parties concerning the relevant facts.  At admission, Vista Manor recognized Resident 3’s risk for falls due to intermittent confusion, decreased muscular coordination, and use of particular medications.  CMS Ex. 4 at 26.  Consistent with that assessment, the facility fashioned a care plan for Resident 3 that identified and sought to ameliorate her risk of falling.  Id. at 12.  In order to reduce the risk of an accident, Petitioner concluded Resident 3 required two people to assist her in activities involving bed mobility and toilet use, requirements for care that it memorialized in both her Minimum Data Set (MDS)9 and her care plan.  CMS Ex. 4 at 11-12; CMS Ex. 9 at 35, 79.

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Facility staff therefore knew or should have known Resident 3 was at high risk of falling due to her physical condition.  Nevertheless, on March 16, 2017, CNA Lucy attempted to shift Resident 3 on her side and change Resident 3’s incontinence pad by herself.  CMS Ex. 9 at 11-16; CMS Ex. 38 at 9.  She did not ask other staff members for assistance because she thought they were busy.  CMS Ex. 38 at 9.  Resident 3 began to slide out of bed, and CNA Lucy was unable to prevent her fall.  CMS Ex. 9 at 11-16; CMS Ex. 38 at 9.  Resident 3 sustained a fracture in her right femur as a result.  CMS Ex. 9 at 99, 110-11; CMS Ex. 38 at 9.

Petitioner does not claim CNA Lucy’s actions were consistent with Resident 3’s care plan.  The facility nevertheless argues it did not fail to meet its obligations under 42 C.F.R. § 483.25(d) because Resident 3’s fall was “unpredictable.”  P. Br. at 11-12.  The facility asserts that Resident 3’s care plan only represented Resident 3’s need for assistance at “a certain point in time” and “is not meant to establish the number of staff needed at any one time, because the amount of assistance required to assist the resident at any given time may change based on the resident’s condition, energy level, and personal preferences.”  Id.  Petitioner claims CNA Lucy more generally acted “in accordance with the [activities of daily living] care plan, which promotes assistance as needed, allows resident to make choices and encourages resident to do as much as possible.”  Id. at 12, citing CMS Ex. 9 at 79.

Petitioner attempts to reinforce its claim that Resident 3 did not actually require the level of assistance memorialized in her care plan by citing “flow sheets” that demonstrated Resident 3 typically “received the routine assistance of one person for the day shift, frequently one person on the evening shift and occasionally one person during the night shift.”  P. Br. at 11, citing CMS Ex. 4 at 16-23.  Petitioner also points to the March 7, 2017 MDS assessment completed by the facility, which documented the facility’s assessment that Resident 3 only required the assistance of one person for changing her incontinence pads.  P. Br. at 12, citing CMS Ex. 4 at 27.     

Petitioner’s arguments are unpersuasive.  A facility violates section 483.25(d) if it fails, without justifiable reason, to implement the accident precautions its own staff have determined are necessary to mitigate foreseeable accidents.  Good Shepard Home for the Aged, Inc., DAB No. 2858 at 14 (2008), citing Del Rosa Villa, DAB No. 2458 at 9, aff’d Del Rosa Villa v. Sebelius, 546 F. App’x 666 (9th Cir. 2013). 

Petitioner has not persuaded me that it was appropriate to ignore Resident 3’s care plan.  Broadly speaking, a resident’s care plan describes the services that are to be furnished to assist the resident to attain or maintain her highest practicable physical, mental, and psychosocial well-being.  Deltona Health Care, DAB No. 2511 at 18 (2013), quoting Sheridan Health Care Ctr., DAB No. 2178, at 37 (2008) (a comprehensive care plan “functions as a roadmap for all of the resident’s caregivers, including those unfamiliar with a resident or without professional training, to provide consistent care and services

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tailored to ‘attain or maintain the [resident’s] highest practicable physical, mental and psychosocial well-being.’”). 

The regulations governing skilled nursing facilities require them to develop a comprehensive care plan for each resident within seven days of a comprehensive assessment following admission.  42 C.F.R. §§ 483.21(b)(1), (b)(2)(i).  That plan must identify measurable objectives and timeframes to address a resident’s medical, nursing, and mental needs.  Id. at § 483.21(b)(1).  It must also identify services that will be provided to that end, those which the resident has declined, and include consultation with the resident or his or her representative concerning the resident’s goals and needs.  Id. at §§ 483.21(b)(1)(i), (ii), (iv). 

A resident’s care plan thus memorializes services necessary to meet the resident’s needs based on the comprehensive assessment as it is revised to reflect the resident’s current status.  Revision of the assessment and care plan is required as often as is necessary to ensure that the resident’s status and need for care and services are accurately identified and met.  42 C.F.R. § 483.21(b)(2)(iii) (“A comprehensive care plan must be . . . [r]eviewed and revised by the interdisciplinary team after each assessment . . . .”). 

I am unpersuaded by Petitioner’s claim that care plans are not intended to document a resident’s needs on an ongoing basis, or that they are so informal they could be ignored or revised by members of facility staff as they deemed fit.  Such a claim is clearly at odds with the specific requirements imposed on facilities like Petitioner by the regulations.  The record shows no assessment by an interdisciplinary team or subsequent revision to Resident 3’s care plan that would support Petitioner’s assertion that its assessment of Resident 3’s assistive needs had changed.  Resident 3’s care plan clearly required facility staff to provide Resident 3 with the assistance of two staff members for toilet use and bed mobility activities.  CMS Ex. 4 at 11; CMS Ex. 9 at 79.    

And while it is true that the March 7, 2017 MDS assessment of Resident 3 indicated she was able to engage in toilet use with only one-person assistance, see CMS Ex. 4 at 27, this does not justify CNA Lucy’s actions here.  While that assessment did reflect that Resident 3 needed the assistance of only one person for activities involving toilet use, it still documented her need for the assistance of two persons for bed mobility, which incorporates “how resident moves to and from lying position, turns side to side, and positions body while in bed.”  CMS Ex. 4 at 27. 

The accident at issue here involved both toilet use and bed mobility activities, since CNA Lucy had to turn Resident 3 on her side while in bed in order to change her incontinence pad.  CMS Ex. 4 at 27.  It would not have been possible to assist Resident 3 in toilet use without changing her position in bed, meaning two people were required for the task.  In any event, the facility did not update Resident 3’s care plan following this MDS assessment, as the regulations require.  Therefore facility staff like CMS Lucy should

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have relied upon the care plan, which indicated Resident 3 was totally dependent and required two-person assistance for both toilet use and bed mobility.  CMS Ex. 9 at 79.  

Petitioner bizarrely attempts to demonstrate that Resident 3’s care plan did not accurately reflect the level of assistance appropriate for her by documenting the fact that for months preceding her fall, it had routinely provided Resident 3 the assistance of only one staff member for bed mobility and toilet use.10  Petitioner appears to contend this persistent failure to follow Resident 3’s care plan reflected the facility’s “finding” that Resident 3 only required one-person assistance for these activities of daily living.  P. Closing Br. at 4.

This claim is specious and borders on absurd; Petitioner cannot modify a resident’s plan of care by custom or practice.  As I have discussed, the regulations required the facility to document a care plan with specificity, and modify and revise it where necessary following assessment by the resident’s doctors and caregivers.  42 C.F.R. § 483.21(b).  It would make little sense to require a facility to document a care plan if it was free to revise it informally as it or its staff deemed appropriate.  All Petitioner has established is that despite Resident 3’s documented high risk of falls, Petitioner’s staff routinely disregarded her care plan for months.  CMS Ex. 4 at 16-23.  The fact that Resident 3 fell was not at all “unpredictable,” as the facility claims.  It appears to have been inevitable. 

In sum, Petitioner assessed Resident 3 on admission and recognizing her high risk for falls, fashioned a care plan that required two-person assistance for activities of daily living like toilet use and bed mobility.  Resident 3 subsequently fell and broke her leg while receiving assistance from only one person.  Petitioner failed to comply with the care plan it had developed based on a comprehensive assessment of Resident 3.  By doing so, the facility did not take all reasonable measures to reduce the foreseeable risks of harm to Resident 3, and therefore was not in substantial compliance with 42 C.F.R. § 483.25(d).  Lifehouse of Riverside Healthcare Ctr., DAB No. 2774 at 19 (2017) (providing a facility “must follow through on safety measures it adopted based on a known risk of harm.”).  I therefore conclude Petitioner violated 42 C.F.R. § 483.25(d) based on its failure to provide adequate assistance to Resident 3 on March 16, 2017, resulting in her fall and injury. 

2.  A per-instance CMP of $15,000 is a reasonable enforcement remedy for Petitioner’s noncompliance with 42 C.F.R. § 483.25(d).

Where a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, including a CMP.  In determining whether the per-instance CMP amount

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imposed against Petitioner is reasonable, I apply the factors listed in 42 C.F.R. § 488.438(f).  42 C.F.R. § 488.438(e)(3).  These factors include:  (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 particular regulatory factor does not support the CMP amount that CMS proposed, I must sustain it.  Coquina Ctr., DAB No. 1860 at 32 (2002). 

Here, CMS imposed a per-instance CMP of $15,000, falling in the mid-to-higher-end of the range for a per-instance CMP ($2,097-$20,965).  42 C.F.R. § 488.408(e)(1)(iv).    With respect to the section 488.438(f) factors, Petitioner does not claim that its financial condition affects its ability to pay the CMP.  CMS has proffered evidence of Petitioner’s history of noncompliance, namely deficiencies cited in 2014 through 2016.  CMS Ex. 29 at 3-5.  CMS does not appear to have increased the CMP based on the facility’s prior history of deficiencies.  For the limited purpose of assessing the reasonableness of the penalty, I note the relevant prior deficiencies are cited at a “D” scope and severity or higher, reflecting lower to moderate levels of past noncompliance which do not suggest a higher CMP would be more reasonable.  However, in conjunction with the other factors I address here, the facility’s compliance history provides no basis to reduce the penalty either.

The facility claims the CMP is not reasonable because it “provided a level of assistance for [Resident 3’s] toileting needs that was appropriate to the resident at the time of the incident.”  P. Br. at 17.  Petitioner also argues that CNA Lucy’s “commendable conduct” in assisting Resident 3 to the floor should be considered in reducing the amount of the CMP.  P. Closing Br. at 9.  I take these assertions to be a claim that the facility’s level of culpability is low. 

I reject these assertions as a basis to find Petitioner’s noncompliance less culpable.  As I have explained, Petitioner did not provide a level of assistance appropriate under Resident 3’s care plan for either toilet use or bed mobility.  And the effort of Petitioner’s employee to minimize the harm caused by her failure to comply with Resident 3’s care plan seems paltry compared to that resident’s broken femur. 

Turning to the other factors, I find the nature of the facility’s noncompliance in this case to be serious.  Resident 3 was entirely dependent on Petitioner to ensure her safety during most activities of daily living.  But despite recognizing her fragility and developing a care

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plan to prevent foreseeable accidents, Petitioner freely admitted its staff disregarded Resident 3’s care plan for months by routinely providing the assistance of one staff member for various activities of daily living.  P. Br. at 11; P. Closing Br. at 4.  This disregard for Resident 3’s care and safety resulted in her falling from her bed and sustaining a fractured femur.  Petitioner’s disregard for Resident 3’s care, comfort, or safety demonstrates a high level of culpability.  In consideration of all the relevant factors, I conclude that the imposition of a $15,000 per-instance CMP is reasonable.   

IX.  Conclusion

For the foregoing reasons, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d) (cited as Tag F323).  Further, I conclude that the per-instance CMP of $15,000 for noncompliance with 42 C.F.R. § 483.25 is a reasonable enforcement remedy.

• 1. CMS substantially revised and re-codified the regulations concerning skilled nursing facilities as of November 28, 2016.  81 Fed. Reg. 68,688 (Oct. 4, 2016).  At the time of the survey, the regulation requiring facilities to keep resident environments free of accidents and hazards and adequately supervise residents was housed at 42 C.F.R. § 483.25(h).  CMS notified Petitioner of its noncompliance in December 2017, after the recodification took place, and cited the newly reorganized regulation in effect at that time, 42 C.F.R. § 483.25(d).  CMS Ex. 2 at 1.  While I typically rely on (and cite to) the regulations in effect at the time of the survey, here the regulatory provision is identical and was simply relocated between the date of the survey and the date of the notice of deficiency.  For the sake of simplicity, I will refer to 42 C.F.R. § 483.25(d), as there was no substantive change in the facility’s obligations related to this provision as a result of the reorganization.
• 2. CMS modified its deficiency tags to conform to the reorganized regulations on June 30, 2017, but the tag changes did not become effective until November 28, 2017, after the survey at issue here took place.  Ctrs. for Medicare & Medicaid Servs., Center for Clinical Standards and Quality/Survey & Certification Group, Revisions to State Operations Manual (SOM) Appendix PP for Phase 2, F-Tag Revisions, and Related Issues, available at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-17-36.pdf (eff. Nov. 28, 2017).  Following the survey, the tag relating to accidents and supervision was relocated to Tag F689.  This change in tag identifier did not substantively change the language of the tag, which conforms to the regulatory requirement for which Petitioner received a notice of deficiency and per-instance CMP.  For the sake of simplicity, I will refer to Tag F323.
• 3. The drafters made plain their intent to limit appeals to only those deficiencies resulting in penalties, stating:  “if no remedy is imposed, the provider has suffered no injury calling for an appeal.”  59 Fed. Reg. 56,116, 56,158 (Nov. 10, 1994).
• 4. Petitioner makes no further argument to support its assertion, and CMS failed to respond at all.  Both parties briefed all the deficiencies, and neither party further addressed this issue in their closing briefs.  Because this issue concerns the scope of my jurisdiction, the parties should have made a greater effort (or in CMS’s case, an effort) to assert and explain their positions.
• 5. The distinction between a per-day and per-instance penalty may also affect the materiality of an unpenalized deficiency.  The applicable regulations permit CMS to impose a CMP “for either the days a facility is not in substantial compliance with one or more participation requirements or for each instance that a facility is not in substantial compliance…”).  42 C.F.R. § 488.430(a) (emphasis added).  A per-day penalty for each day a facility is not compliant with “one or more participation requirements” is thus based on all cited deficiencies because the penalty will not cease until the facility corrects all of them.  The per-day CMP imposed in Plott was thus at least potentially affected by all cited deficiencies, which could have affected both the per-day CMP amount and the duration of the penalty period.  By contrast, a per-instance penalty has no duration period, and is not necessarily based on all cited deficiencies.
• 6. CMS increased the CMP amounts to account for inflation in compliance with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, Pub. L. No. 114-74, § 704, 129 Stat. 584, 599 (2015). See 81 Fed. Reg. 61,538 (Sept. 6, 2016). The inflation-adjusted amounts apply to CMPs assessed after August 1, 2016, for deficiencies occurring on or after November 2, 2015. Id. at 61,538. As the CMPs in this case were assessed after August 1, 2016, the increased CMP amounts apply in this case.
• 7. Surveyor Florencia Monis explained that this individual no longer worked for Vista Manor by the time of the survey, so she was not interviewed.  CMS Ex. 38 at 8-9.  Surveyor Monis instead spoke to other members of the facility’s staff, and characterized their description of the events surrounding Resident 3’s fall as “consistent.”  Id. at 9.
• 8. My conclusions of law and findings of fact are bolded and italicized.
• 9. The MDS provides a comprehensive assessment of a resident’s functional capabilities and health problems.  See 42 C.F.R. § 483.20(b).
• 10. It does not appear Petitioner’s staff believed this to be true.  Both the shift supervisor and the Assistant Director of Nursing told a surveyor that they believed CNA Lucy acted inappropriately and that Resident 3 generally required the assistance of two staff members for her care.  CMS Ex. 38 at 10.