Rehabilitation Center of Des Moines, DAB CR6040 (2022)

DECISION

Petitioner violated 42 C.F.R. § 483.25(n).1   However, the violation did not pose a risk for more than minimal harm.  Therefore, there was no noncompliance, Petitioner was in substantial compliance with program participation requirements, and there is no basis for the imposition of a per instance civil money penalty (PICMP).  The $13,500 PICMP proposed by the Centers for Medicare & Medicaid Services (CMS) is an unreasonable enforcement remedy.  

I.  Background

Petitioner is located in Des Moines, Iowa.  Petitioner participates in Medicare as a skilled nursing facility (SNF).  On March 5, 2018, the Iowa Department of Inspections and Appeals (state agency) completed a survey of Petitioner’s facility.  The surveyor alleged

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in the Statement of Deficiencies (SOD) that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(n)(1)-(4) (Tag F7002 ) (Bed Rails).  CMS Exhibit (Ex.) 1 at 7-16; Petitioner’s Exhibit (P. Ex.) 2.  The surveyor alleged in the SOD that the deficiency posed immediate jeopardy at a scope and severity level of J and that the immediate jeopardy was abated on February 28, 2018.3   CMS Ex. 1 at 7-8.

On April 9, 2018, CMS issued an initial determination adopting the state agency’s findings and imposing a PICMP of $13,500 based on the alleged noncompliance cited under Tag F700.  CMS Ex. 4. 

On May 17, 2018, Petitioner requested a hearing before an administrative law judge (ALJ).  On May 25, 2018, the case was assigned to me for hearing and decision, and an Acknowledgment and Prehearing Order was issued.

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On September 24, 2018, CMS filed its prehearing brief (CMS Br.) and CMS Exs. 1 through 5.  On November 21, 2018, Petitioner filed its prehearing brief (P. Br.) and P. Exs. A through N.

On November 8, 2019, the parties filed a joint motion waiving an oral hearing and agreed to a decision on the written record.  On the same date, I accepted the waiver of oral hearing and set a briefing schedule.  On December 23, 2019, the parties filed proposed findings of fact and conclusions of law.  Each party waived the opportunity to file an additional brief on the merits and advised me that they would rely on their prehearing briefs and evidence previously filed.  No objections have been made to my consideration of the exhibits submitted.  CMS Exs. 1 through 5 and P. Exs. A through N are admitted as evidence.  

II.  Discussion

A.  Issues

Whether there is a basis for the imposition of an enforcement remedy; and, 

Whether the remedy imposed is reasonable.

B.  Applicable Law

1.  Statutory and Regulatory Medicare Program Enforcement

The statutory and regulatory requirements for participation of a SNF in Medicare are at section 1819 of the Social Security Act (Act) and 42 C.F.R. pt. 483.  Section 1819(h)(2) of the Act authorizes the Secretary (the Secretary) of Health and Human Services (HHS) to impose enforcement remedies against a SNF for failure to comply substantially with the federal participation requirements established by sections 1819(b), (c), and (d) of the Act.4  The Act requires that the Secretary terminate the Medicare participation of any SNF that does not return to substantial compliance with participation requirements within six months of being found not to be in substantial compliance.  Act § 1819(h)(2)(C).

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The Act also requires that the Secretary deny payment of Medicare benefits for any beneficiary admitted to a SNF if the SNF fails to return to substantial compliance with program participation requirements within three months of being found not to be in substantial compliance – commonly referred to as the mandatory or statutory denial of payments for new admissions (DPNA).  Act § 1819(h)(2)(D).  The Act grants the Secretary discretionary authority to terminate a noncompliant SNF’s participation in Medicare, even if there has been less than six months of noncompliance.  The Act also grants the Secretary authority to impose other enforcement remedies, including a discretionary DPNA, CMPs, appointment of temporary management, and a directed plan of correction.  Act § 1819(h)(2)(B).

The Secretary has delegated to CMS and the states the authority to impose remedies against a SNF or NF that is not in substantial compliance with federal participation requirements.  42 C.F.R. §§ 488.400, 488.402(b).  “Substantial compliance means a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301 (emphasis in original).  A deficiency is a violation of a participation requirement established by sections 1819(b), (c), and (d) of the Act or the Secretary’s regulations at 42 C.F.R. pt. 483, subpt. B.  42 C.F.R. § 488.301.  The term “noncompliance” refers to any deficiency (statutory or regulatory violation) that causes a facility not to be in substantial compliance; that is, a deficiency that poses a risk for more than minimal harm.  42 C.F.R. § 488.301.  Therefore, even if a facility violates a statutory or regulatory requirement, CMS may not impose enforcement remedies if the deficiency does not pose a risk for more than minimal harm. 

State survey agencies survey facilities that participate in Medicare on behalf of CMS to determine whether the facilities are complying with federal participation requirements.  42 C.F.R. §§ 488.10‑.28, 488.300-.335.  The regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance with Medicare requirements.  42 C.F.R. § 488.406.

CMS is authorized to impose a CMP against a facility not in substantial compliance with program participation requirements.  CMS is authorized to impose a CMP on a per day or per instance basis.  In this case, CMS proposed a PICMP.  CMS is authorized to impose a PICMP in the range of $2,097 to $20,965.  42 C.F.R. §§ 488.408(d), (e); 488.438(a)(2); 45 C.F.R. § 102.3 (Table) (2017).  

Petitioner was also notified that it may be ineligible to conduct a nurse aide training and competency evaluation program (NATCEP). CMS Ex. 4 at p. 2.  Pursuant to sections 1819(b)(5) and 1919(b)(5) of the Act, SNFs and NFs may only use nurse aides who have completed a training and competency evaluation program.  Pursuant to sections 1819(f)(2) and 1919(f)(2) of the Act, the Secretary was tasked to develop requirements for approval of NATCEPs and the process for review of those programs.  Sections

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1819(e) and 1919(e) of the Act impose upon the states the requirement to specify what NATCEPs they will approve that meet the requirements that the Secretary established and a process for reviewing and re-approving those programs using criteria the Secretary set.  The Secretary promulgated regulations at 42 C.F.R. pt. 483, subpt. D.  Pursuant to 42 C.F.R. § 483.151(b)(2) and (f), a state may not approve, and must withdraw, any prior approval of a NATCEP offered by a SNF or NF that has been:  (1) subject to an extended or partial extended survey under sections 1819(g)(2)(B)(i) or 1919(g)(2)(B)(i) of the Act; (2) assessed a CMP of not less than $10,483 (45 C.F.R. §102.3 (Table)) (2017); or (3) subject to termination of its participation agreement, a DPNA, or the appointment of temporary management.  Extended and partial extended surveys are triggered by a finding of “substandard quality of care” during a standard or abbreviated standard survey and involve evaluating additional participation requirements.  “Substandard quality of care” is identified by the situation where surveyors identify one or more deficiencies related to participation requirements established by 42 C.F.R. §§ 483.10, 483.12, 483.24, 483.25, 483.40, 483.45, 483.70 or 483.80, which are found to constitute either immediate jeopardy, a pattern of or widespread actual harm that does not amount to immediate jeopardy, or a widespread potential for more than minimal harm that does not amount to immediate jeopardy and there is no actual harm.  42 C.F.R. § 488.301.  The CMP proposed by CMS triggered the ineligibility to be approved to conduct a NATCEP in this case.  Ineligibility to conduct a NATCEP is not an enforcement remedy that the state agency and CMS have the authority or discretion to impose.  42 C.F.R. § 488.406 (list of remedies CMS and the state agency are authorized to impose in addition to termination). 

The Act and regulations make a hearing before an ALJ available to a SNF against which CMS has determined to impose an enforcement remedy.  Act §§ 1128A(c)(2), 1866(h); 42 C.F.R. §§ 488.408(g), 498.3(b)(13).  A facility has a right to appeal a “certification of noncompliance leading to an enforcement remedy.”  42 C.F.R. §§ 488.408(g)(1); 488.330(e), 498.3(b)(13).  However, the choice of remedies, or the factors CMS considered when choosing remedies, are not subject to review.  42 C.F.R. § 488.408(g)(2).  A facility may only challenge the scope and severity level of noncompliance determined by CMS if a successful challenge would affect the range of the CMP that may be imposed or impact the facility’s authority to conduct a NATCEP.  42 C.F.R. § 498.3(b)(14), (d)(10)(i).  The CMS determination as to the level of noncompliance, including the finding of immediate jeopardy, “must be upheld unless it is clearly erroneous.”  42 C.F.R. § 498.60(c)(2); Woodstock Care Ctr., DAB No. 1726 at 9, 39 (2000), aff’d, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003).  The Board has long held that the net effect of the regulations is that a provider has no right to challenge the scope and severity level assigned to a noncompliance finding, except in the situation where that finding was the basis for an immediate jeopardy determination.  See, e.g., Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750 (2000).  ALJ review of a CMP is subject to 42 C.F.R. § 488.438(e).

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2.  Burden of Proof, Burden of Production, and Quantum of Evidence

The hearing before an ALJ is a de novo proceeding, that is, “a fresh look by a neutral decision-maker at the legal and factual basis for the deficiency findings underlying the remedies.”  Life Care Ctr. of Bardstown, DAB No. 2479 at 33 (2012) (citation omitted). 

The allocation of the burden of proof and the quantum of evidence required to meet the burden is not addressed by regulations applicable in this case.5  Rather, the Board has long held that the petitioner, i.e., the nongovernmental party, bears the ultimate burden of persuasion to show by a preponderance of the evidence that it was in substantial compliance with participation requirements or any affirmative defense.  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); Cross Creek Health Care Ctr., DAB No. 1665 (1998); Hillman Rehab. Ctr., DAB No. 1611 (1997) (remand to ALJ), DAB No. 1663 (1998) (after remand), aff’d, Hillman Rehab. Ctr. v. United States, No. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999).  The Board has indicated that CMS has the initial burden of production to make a prima facie showing of noncompliance.  If CMS makes a prima facie showing, then the facility bears the burden to show, by a preponderance of the evidence on the record as a whole, that it was in

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substantial compliance or had an affirmative defense.  Evergreene Nursing Care Ctr., DAB No. 2069 at 7 (2007).  The Board has not clearly defined the quantum of evidence CMS needs to present to meet its burden of making a prima facie showing.  The Board has stated that CMS must come forward with “evidence related to disputed findings that is sufficient (together with any undisputed findings and relevant legal authority) to establish aprima facie case of noncompliance with a regulatory requirement.”  Id.; Batavia Nursing & Convalescent Ctr., DAB No. 1904.  “Prima facie” means generally that the evidence is “[s]ufficient to establish a fact or raise a presumption unless disproved or rebutted.”  Black’s Law Dictionary 1228 (8th ed. 2004).  One might conclude that if the preponderance of the evidence is required in these proceedings, that standard would also apply to the requirement for CMS to make a prima facie showing, i.e., CMS should be required to present evidence sufficient to establish a fact as more likely true and to raise a presumption, subject to being disproved or rebutted.  However, the Board has never specifically ruled that the CMS prima facie case must be supported by preponderant evidence, or what happens if it is not, including whether the burden shifts to Petitioner or not.  It is unclear from prior Board decisions whether CMS can make a prima facie showing with little more than mere allegations or a scintilla of evidence.  In this case based on the following analysis, I conclude that CMS has made a prima facie showing of noncompliance by a preponderance of the evidence. 

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

My conclusions of law are set forth in bold text followed by my findings of fact and analysis.  I have carefully considered all the evidence and the arguments of both parties, though not all may be specifically discussed in this decision.  I discuss in this decision the credible evidence given the greatest weight in my decision-making.6   I also discuss any evidence that I find is not credible or worthy of weight.  The fact that evidence is not specifically discussed should not be considered sufficient to rebut the presumption that I considered all the evidence and assigned such weight or probative value to the credible evidence that I determined appropriate within my discretion as an ALJ.  There is no requirement for me to discuss the weight given every piece of evidence considered in this case, nor would it be consistent with notions of judicial economy to do so.  Charles H. Koch, Jr., Administrative Law and Practice § 5:64 (3d ed. 2013).

Based on the survey that ended March 5, 2018, CMS cited Petitioner with an alleged isolated violation of 42 C.F.R. § 483.25(n)(1)-(4) (Tag F700) that was identified on

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February 28, 2018, and allegedly posed immediate jeopardy.  CMS Ex. 1 at 8-16; P. Ex. 2 at 1-10.  CMS proposes to impose a $13,500 PICMP based on the noncompliance.

Petitioner does not dispute that CMS made a prima facie showing of a violation of 42 C.F.R. § 483.25(n).  However, Petitioner disputes that there was any risk for harm to a resident due to the regulatory violation.  P. Br. at 3-6.  CMS is authorized to impose an enforcement remedy for noncompliance.  Noncompliance is failure to comply with a participation requirement (i.e., a statutory or regulatory violation) that poses a risk for more than minimal harm to resident health or safety.  42 C.F.R. §§ 488.301, 488.402(b).

1.  CMS made a prima facie showing that Petitioner violated 42 C.F.R. § 483.25(n) (Tag F700).  

2.  The violation of 42 C.F.R. § 483.25(n) did not pose a risk for more than minimal harm.

3.  Petitioner was in substantial compliance with the participation requirement established by 42 C.F.R. § 483.25(n) because the violation of the regulation did not pose a risk for more than minimal harm and, therefore, did not amount to noncompliance.  

An annual health survey of Petitioner was completed on March 5, 2018.  The survey determined that Petitioner was not in substantial compliance with 12 Medicare participation requirements.  CMS Ex. 1.  CMS advised Petitioner by its initial determination dated April 9, 2018, that it was imposing a PICMP of $13,500 based only upon the alleged noncompliance under Tag F700, the violation of 42 C.F.R. § 483.25(n) that allegedly posed immediate jeopardy.7   CMS Ex. 4.  I conclude that only the alleged

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noncompliance under Tag F700 is at issue before me because that is the only noncompliance cited by CMS as a basis for the imposition of an enforcement remedy.  42 C.F.R. §§ 488.408(g)(1); 488.330(e), 498.3(b)(13). 

a.  Facts

The alleged noncompliance in this case involved Resident 51.  The parties stipulated that Resident 51 suffered from quadriplegia, muscle weakness (generalized), central cord syndrome of the cervical spinal cord, reduced mobility, lack of coordination, hypertension, Type 2 diabetes mellitus, anxiety, depression, and a cognitive communication deficit.  Resident 51 was assessed as moderately cognitively impaired.  Resident 51 required maximum assistance of two staff for bed mobility, toilet use, and hygiene, and he was totally dependent on staff for transfers.  Resident 51 was prescribed and wore a cervical J-Collar at all times.  Joint Stipulation of Undisputed Facts (Jt. Stip.) at 1. 

Based on clinical records in evidence, Resident 51 was originally admitted to Petitioner on December 19, 2017, and was readmitted on January 16, 2018 from an acute care hospital.  CMS Ex. 2 at 3.  A quarterly review assessment of the resident was done with an assessment reference date of February 13, 2018, and a Minimum Data Set (MDS) was completed on February 23, 2018.  CMS Ex. 2 at 1, 4, 41.  The MDS indicated that, during the assessment period, Resident 51 required extensive assistance of two staff for bed mobility, toilet use, and personal hygiene.  He was assessed as totally dependent and required two staff for transfer between surfaces, such as bed to chair or wheelchair.  He could not walk.  He required extensive assistance of one staff member for locomotion using a wheelchair.  He was totally dependent on staff for bathing. CMS Ex. 2 at 11-12.  Active diagnoses at the time of the assessment included anemia, hypertension, urinary tract infection, diabetes mellitus, quadriplegia, anxiety, depression, lack of coordination, central spinal cord syndrome, muscle weakness, reduced mobility, mild cognitive impairment, dehydration, cirrhosis of the liver, and other specified disorders of the veins.  CMS Ex. 2 at 18-19’ P. Ex. C.  He weighed 310 pounds.  CMS Ex. 2 at 22.  The assessment indicates bed rails were not being used for the resident at the time of the assessment.  CMS Ex. 2 at 33.  However, one-quarter bed rails were ordered as a mobility enabler on January 16, 2018, and a bed side rail assessment was done on that date.  CMS Ex. 2 at 122, 128; CMS Ex. 3 at 9.  There is no dispute that bed rails were in use at the time of the survey, even if there is some conflicting evidence as to when that intervention was first implemented.

Resident 51’s base-line care plan shows that he had an air mattress to prevent skin breakdown, he was to wear a J-collar at all times, and he was totally dependent on the assistance of two staff for bed mobility, transfers, toileting, locomotion, grooming and hygiene, and bathing.  CMS Ex. 2 at 112-13, 116; CMS Ex. 3 at 2-3, 6; P. Ex. I; P. Ex. J at 2-3, 5.

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A care plan for Resident 51 initiated on December 20, 2017, indicates he was unable to turn himself.  CMS Ex. 3 at 26; P. Ex. F. 

A progress note dated February 13, 2018, indicates he had decreased grasp on both the left and right side, he had decreased movement of both the left and right upper extremity, and he had decreased sensation in both lower extremities.  The note indicates that he was totally dependent on two staff for bed mobility.  P. Ex. H.  

On February 28, 2018, during the survey, another a bed rail assessment was done.  Bed rails were determined to be necessary for use with Resident 51’s bariatric bed with a low air loss mattress to promote bed mobility.  Resident 1’s head and body were assessed as large enough not to be entrapped in the bed rails or the gap between the rails and the mattress.  CMS Ex. 2 at 117-18; CMS Ex. 3 at 12-14.  I infer that this assessment is related to the new mattress placed on Resident 51’s bed on February 28, 2018, after the surveyor’s observations of the gaps between the mattress and side rails on the resident’s prior bed.  CMS Ex. 2 at 120; CMS Ex. 3 at 21, 24, 46.

The surveyor recorded in the SOD that Resident 51 was observed on February 26, 2018, lying on an air mattress with the bed rails up on both sides at the head of the bed.  A gap between the air mattress and bed rails was noted, but no measurement was recorded in the SOD.  Resident 51 was observed in bed again on February 28, 2018, lying on his back on an air mattress in bed with his J-Collar in place with both bed rails up.  Gaps were noted by the surveyor between the air mattress and bed rails on both sides.  The gap on one side was measured as four inches and the gap on the other side was measured as eight inches, a total gap of 12 inches.  The gaps were shown to Petitioner’s Administrator and the Director of Nursing.  The maintenance supervisor was contacted, and he confirmed that the mattress in use was only 42 inches wide and it should have been 48 inches wide.  CMS Ex. 1 at 12-13; P. Ex. B at 6-8.  The surveyor determined the gaps posed immediate jeopardy for Resident 51, which was removed on February 28, 2018 when Resident 51 was moved to another bed or mattress with no entrapment risk.  CMS Ex. 1 at 8, 16; P. Ex. B at 2, 10.  Petitioner does not dispute the observations of the surveyor.  P. Br.  The surveyor alleges that Resident 51 was the only resident at risk among Petitioner’s 60 residents at the time.  CMS Ex. 1 at 8; P. Ex. B at 2; CMS Ex. 5.  The parties stipulated that Resident 51 suffered no injury, and no resident of Petitioner suffered entrapment or a related injury.  Jt. Stip. at 1-2.

According to the surveyor, the Food and Drug Administration (FDA) recommends that the space between a mattress and bed rail should not be so large that a resident can fall between the mattress and bed rail and be entrapped, which can cause serious injury or death.  The FDA recommends that the space between the inside of the bed rail and the mattress should be no more than 4.75 inches to prevent possible entrapment.  CMS Ex. 1 at 8-10; P. Ex. B at 2-4.  The FDA guidance is not in evidence other than the recitation in

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the SOD.  However, the accuracy of the description of the FDA guidance in the SOD has not been disputed.  Petitioner had a safety program for bed rails, which provided that Petitioner adopted the FDA-approved measurements and guidance for bed rails.  CMS Ex. 3 at 48-49.

Petitioner submitted the written testimony of Benjamin Powers, PT, DPT, who provided Resident 51 physical therapy services, including the period of the survey.8   Mr. Powers testified, based on his observations and personal knowledge of Resident 51, that the resident was totally dependent on staff for bed mobility, he could not independently reach to either side or roll to either side and could not roll from his back to either side.  He testified that Resident 51 could not use his bed rails to independently reposition himself in bed due to lack of upper extremity strength and lack of mobility.  He testified that the bed rails were used only to facilitate delivery of care by staff.  Staff would roll Resident 51 to his side and place his arm over the bed rail for stability. However, Resident 51 was only placed in that position while staff was present, and care was being delivered.  P. Ex. K.  Mr. Powers’ testimony is unrebutted and consistent with other evidence of record including CMS Ex. 2 at 112-13, 116; CMS Ex. 3 at 2-3, 6, 26; P. Ex. F; P. Ex. H; P. Ex. I; P. Ex. J at 2-3, 5.  I accept Mr. Powers’ testimony as fully credible.

Petitioner submitted the written testimony of Amanda Thacker, LPN, who testified that she began providing care to Resident 51 in December 2017.  She cared for the resident each shift that she worked, and he required care every two hours.  She testified that Resident 51 was totally dependent on staff for bed mobility, transfers, and locomotion.  Resident 51 was placed in his bed on his back with the head of the bed raised 20 to 40 degrees and the bed was lowered only to permit staff to roll him on his side to provide care, after which he was returned to his back and the head of the bed was elevated.  She testified the resident was never left on his side while unattended.  She testified Resident 51 could not independently roll onto his side from his back.  She testified that Resident 51 and his family never expressed any concern about his bed and mattress.  She also testified that the resident’s air mattress held him in the center of the bed.  CMS Ex. L.  LPN Thacker’s testimony is unrebutted and consistent with the other evidence of record and I accept her testimony as fully credible.

Petitioner presented the written testimony of Kelly Bender, RN, Petitioner’s Director of Nursing.  RN Bender testified that during the survey a gap was observed between Resident 51’s mattress and bed rail.  She testified that all 60 facility beds were observed

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during the survey and the gap was identified only in the case of Resident 51.  She opined that Resident 51 was at no risk for any harm or injury due to the gap between his mattress and bed rail because he was physically unable to roll or otherwise move himself into a position that would cause harm or injury.  P. Ex. M.  RN Bender’s testimony is unrebutted and consistent with the other evidence of record and I accept her testimony as fully credible.  

b.  Analysis

A SNF must provide quality care to all facility residents.  The quality-of-care regulation provides:

Quality of care is a fundamental principle that applies to all treatment and care provided to facility residents.  Based on the comprehensive assessment of a resident, the facility must ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the resident’s choices, including but not limited to the following:

42 C.F.R. § 483.25.  The specific regulatory provisions related to the use of bed rails provides:

(n) Bed rails. The facility must attempt to use appropriate alternatives prior to installing a side or bed rail. If a bed or side rail is used, the facility must ensure correct installation, use, and maintenance of bed rails, including but not limited to the following elements.

(1) Assess the resident for risk of entrapment from bed rails prior to installation.

(2) Review the risks and benefits of bed rails with the resident or resident representative and obtain informed consent prior to installation.

(3) Ensure that the bed’s dimensions are appropriate for the resident’s size and weight.

(4) Follow the manufacturers’ recommendations and specifications for installing and maintaining bed rails.  

42 C.F.R. § 483.25(n)(1)-(4).

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The allegation in this case is that the use of the 42-inch air mattress on Resident 51’s bed posed a risk for entrapment because the surveyor measured an eight-inch gap between the resident’s air mattress and the bed rail in use on the bed.9   CMS Ex. 1 at 7-16.  The regulation does not establish a specific standard for how much gap between a mattress and a bed rail is acceptable.  The regulation requires assessment when bed rails are implemented and in use to ensure a resident’s safety.  Under the regulation, any gap should be assessed and determined not to pose an entrapment risk.  The issue of whether or not Resident 51 could actually be entrapped if he rolled into the eight-inch gap or was at a risk for any harm if that occurred, might have been resolved by documentary evidence that an assessment of the resident was done.  An assessment could have determined, for example, whether the resident could roll into the gap at all; if he could, whether he could roll back out or call for assistance; and, if the resident rolled into the eight-inch gap, whether he was at risk for suffocation or other harm.  A documented assessment may have avoided the citation of deficiency in this case.  Unfortunately, the assessment is not documented in the record before me.

The surveyor cites the recommendation of the FDA that a gap between a bed rail and mattress should be no more than 4.75 inches.  CMS Ex. 1 at 8-10.  The FDA recommendation is not mentioned in 42 C.F.R. § 483.25(n) or incorporated by reference.  However, Petitioner’s bed rail safety policy indicates that Petitioner adopteded the FDA measurements and guidance related to bed rail safety.10   CMS Ex. 3 at 48-49.  Applying the FDA recommendation in this case as a standard of care, the four-inch gap between Resident 51’s mattress and bed rail (CMS Ex. 1 at 13) did not violate the FDA recommended maximum 4.75-inch gap.  However, the eight-inch gap on the opposite side of the mattress clearly exceeded the FDA recommendation.  The evidence does not show that Petitioner actually assessed whether Resident 51 could be entrapped if he rolled into the eight-inch gap.

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In this case, Petitioner accepts the mechanical application of the FDA recommendation and concedes that CMS has made a prima facia showing of a violation of 42 C.F.R. § 483.25(n).  P. Br. at 1.  I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.25(n) because Petitioner failed to submit evidence that it conducted an assessment as required by 42 C.F.R. § 483.25(n) to determine whether Resident 51 was at risk due to the use of the 42-inch air mattress on his bed with bed rails.  Petitioner does not specifically dispute that CMS has shown that the violation posed a risk for more than minimal harm but does challenge the declaration of immediate jeopardy.  P. Br. at 1-2.  I conclude that CMS has made a prima facie showing of noncompliance under Tag F700 based on a violation of 42 C.F.R. § 483.25(n) that posed a risk for more than minimal harm. 

Petitioner focuses on challenging whether its violation of 42 C.F.R. § 483.25(n) posed immediate jeopardy to Resident 51.  P. Br. at 1-2.  Petitioner failed to specifically address the more fundamental question of whether its evidence rebuts the required element of CMS’ prima facie case - that the violation of 42 C.F.R. § 483.25(n) posed a risk for more than minimal harm.  I consider both issues, that is:

Whether Petitioner rebutted the CMS prima facie case by showing that the admitted violation of 42 C.F.R. § 483.25(n) posed no risk for more than minimal harm; and

Whether Petitioner has shown that the scope and severity determination of the surveyor and CMS is clearly erroneous.  

i.  Petitioner has shown by a preponderance of the evidence that Resident 51 was at no risk for harm due to Petitioner’s violation of 42 C.F.R. § 483.25(n).

In Hillman Rehab. Ctr., the Board described the elements of the CMS prima facie case in general terms as follows:

HCFA [now known as CMS] must identify the legal criteria to which it seeks to hold a provider.  Moreover, to the extent that a provider challenges HCFA’s findings, HCFA must come forward with evidence of the basis for its determination, including the factual findings on which HCFA is relying and, if HCFA has determined that a condition of participation was not met, HCFA’s evaluation that the deficiencies found meet the regulatory standard for a condition-level deficiency.

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DAB No. 1611 at 8.  Thus, CMS has the initial burden of coming forward with sufficient evidence to show that its decision to impose an enforcement remedy is legally sufficient under the statute and regulations.  To make a prima facie case that its decision was legally sufficient, CMS must:  (1) identify the statute, regulation or other legal criteria to which it seeks to hold the provider; (2) come forward with evidence upon which it relies for its factual conclusions that are disputed by Petitioner; and (3) show how the regulatory violation found amounted to noncompliance that permits the imposition of an enforcement remedy, that is, that there was a risk for more than minimal harm due to the regulatory violation.  42 C.F.R. §§ 488.301, 488.400, 488.402(b), 488.408(g)(1), and 498.3(b). 

I have concluded, based on the concessions of Petitioner, that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.25(n) and that the violation posed a risk for more than minimal harm.  The legal standard violated here is the failure to assess Resident 51, his air mattress, and bed rails to determine whether or not the gaps, at least the eight-inch gap between the mattress and bed rail, posed any risk for harm to Resident 51.  The FDA recommendation that no gap exceed 4.75 inches may arguably establish a presumption that any gap wider than 4.75 inches poses a risk for harm.  However, 42 C.F.R. § 483.25(n) requires an assessment of the resident and his or her bed, not just reliance upon FDA guidance.  Whether or not the regulatory violation posed a risk for more than minimal harm, the third required element of the CMS prima facie case, requires closer examination in light of the evidence produced by Petitioner.  CMS may rely upon a presumption that there is a risk for more than minimal harm based on the regulation, FDA guidance, and CMS policy such as the SOM Tag F700, or the opinion of the surveyor.  However, Petitioner has the opportunity to rebut the CMS prima facie showing by attacking one or more elements of the CMS case, or establishing an affirmative defense.

I conclude that Petitioner’s evidence establishes by a preponderance of the evidence that there was no risk for more than minimal harm to Resident 51 due to the gaps between his mattress and bed rails or the failure of Petitioner to do and document the assessment required by 42 C.F.R. § 483.25(n).  My conclusion is based on my findings of fact.  The evidence presented by Petitioner, including parts of Resident 51’s clinical record and the testimony of Mr. Powers and LPN Thacker, establish that it is more likely than not that Resident 51 could not roll into the gap on either side of his air mattress and become entrapped between the mattress and the bed rail.  The evidence is convincing that Resident 51 was unable to roll from his back to his side and that his air mattress kept him positioned in the center of the mattress.  Therefore, despite the fact Petitioner violated 42 C.F.R. § 483.25(n) by failing to do the required assessment, that violation posed no risk for more than minimal harm.  I also note that it is undisputed that all 60 beds were examined by the surveyor and no other resident was alleged to be at risk due to any violation of 42 C.F.R. § 483.25(n).  CMS Ex. 1 at 8.

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I conclude that Petitioner has rebutted the third element of the CMS prima facie case.  Accordingly, I conclude that while 42 C.F.R. § 483.25(n) was violated by Petitioner, the violation did not pose a risk for more than minimal harm.  Therefore, I further conclude that there is no noncompliance for which CMS is authorized to impose an enforcement remedy. 

ii.  Petitioner has shown that the determination that the violation of 42 C.F.R. § 483.25(n) posed a risk for more than minimal harm or immediate jeopardy was clearly erroneous.

CMS argues that Petitioner is requesting review of the scope and severity determination of CMS, and that such review is unavailable or of no avail.  CMS Br. at 7-8.  I conclude, however, that the CMS arguments do not deprive Petitioner of review of whether there was a risk for more than minimal harm due to the regulatory violation.  Further, while CMS is correct that review of the scope and severity determination is limited, review is not precluded under the regulation contrary to the suggestion of CMS.  Pursuant to 42 C.F.R. § 498.3(b)(14), a petitioner has the right to review of:

(14) The level of noncompliance found by CMS in a SNF, NF, or HHA but only if a successful challenge on this issue would affect –

(i) The range of civil money penalty amounts that CMS could collect . . . ; or

(ii) A finding of substandard quality of care that results in the loss of approval for a SNF or NF of its nurse aide training program.

The credible and weighty evidence shows that there was no risk for more than minimal harm to Resident 51 due to the regulatory violation in this case.  Therefore, there was no noncompliance, i.e., a regulatory violation and a risk for more than minimal harm due to the violation, and CMS is authorized to impose no PICMP.  When a petitioner rebuts by a preponderance of the evidence the CMS showing that there was a risk for more than minimal harm due to a regulatory violation, then no noncompliance exists, no level of noncompliance can be declared by CMS, and there is no basis for the imposition of any enforcement remedy, including a CMP.  However, I conclude there is no different result, even if it is concluded (erroneously in my opinion) that the clearly erroneous standard of

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42 C.F.R. § 498.60(c)(2)11 applies to determine whether Petitioner has rebutted the CMS showing that the regulatory violation posed a risk for more than minimal harm.  Petitioner has met the high burden of showing that the determination of the level of noncompliance is clearly erroneous in this case. 

The clearly erroneous standard is not defined by the Secretary in 42 C.F.R. pts. 488 or 498.  The “clearly erroneous standard” is described in Black’s Law Dictionary as a standard of appellate review applied in judging the trial court’s treatment of factual issues, under which a factual determination is upheld unless the appellate court has the firm conviction that an error was committed.  Black’s Law Dictionary 269 (8th ed. 2004).  The United States Supreme Court has addressed the “clearly erroneous standard” in the context of the federal APA.  The Court described the preponderance of the evidence standard, the most common standard, as requiring that the trier-of-fact believe that the existence of a fact is more probable than not before finding in favor of the party that had the burden to persuade the judge of the fact’s existence.  In re Winship, 397 U.S. 358, 371-72 (1970); Concrete Pipe & Prods. of Cal., Inc. v. Constr. Laborers, 508 U.S. 602, 622 (1993).  The “substantial evidence” standard considers whether a reasonable mind might accept a particular evidentiary record as adequate to support a conclusion.  Consol. Edison, 305 U.S. 197, 229 (1938); Dickinson v. Zurko, 527 U.S. 150, 162 (1999).  Under the “clearly erroneous” standard, a finding is clearly erroneous even though there may be some evidence to support it if, based on all the evidence, the reviewing judge or authority has a definite and firm conviction that an error has been committed.  United States v. U.S. Gypsum Co., 333 U.S. 364, 395 (1948); Dickinson, 527 U.S. at 162; Concrete Pipe, 508 U.S. at 622.

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Based on my review of the evidence, I have a definite and firm conviction that the CMS conclusion that Petitioner’s violation of 42 C.F.R. § 483.25(n) posed a risk for more than minimal harm is clearly erroneous.  Resident 51 was a quadriplegic.  Resident 51 could not roll from his back to his side without the assistance of two staff.  Therefore, there was no risk that he would roll from his back to his side and enter the gap between his air mattress and bed rail without staff assistance, even though there is no dispute that a gap existed that exceeded an FDA recommendation.  Furthermore, the evidence shows that no other resident was at risk for entrapment due to an incorrectly sized air mattress on a bed with bed rails. 

Accordingly, I conclude that Petitioner violated 42 C.F.R. § 483.25(n), but the violation did not pose a risk for more than minimal harm, there is no noncompliance, and no enforcement remedy is authorized under 42 C.F.R. § 488.477. 

4.  The is no basis to impose an enforcement remedy and the CMP imposed is unreasonable.  

I have concluded that Petitioner has met its burden to show that it was in substantial compliance with the participation requirement of 42 C.F.R. § 483.25(n).  Because there was no noncompliance, there is no basis for the imposition of an enforcement remedy and the PICMP imposed is unreasonable.42 C.F.R. § 488.402(b). 

III.  Conclusion

Petitioner was in substantial compliance with 42 C.F.R. § 483.25(n) (Tag F700).  Therefore, there is no basis for the imposition of an enforcement remedy, and the PICMP of $13,500 proposed by CMS is unreasonable.

1. Citations are to the 2017 revision of the Code of Federal Regulations (CFR), which was in effect at the time of the survey, unless otherwise stated.  Good Shepard Home for the Aged, Inc., DAB No. 2858 at 1 n.1 (2018); Carmel Convalescent Hosp., DAB No. 1584 at 2 n.2 (1996).
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2. This is a “Tag” designation as used in CMS Pub. 100-07, State Operations Manual (SOM), app. PP – Guidance to Surveyors for Long Term Care Facilities.  The current SOM is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items/CMS1201984.  The version of Tag F700 in effect at the time of the survey was revision 173, effective November 28, 2017.  The “Tag” refers to the specific regulatory provision allegedly violated and CMS’s policy guidance to surveyors.  Although the SOM does not have the force and effect of law, the provisions of the Act and regulations interpreted clearly do have such force and effect.  Ind. Dep’t of Pub. Welfare v. Sullivan, 934 F.2d 853 (7th Cir. 1991); Nw. Tissue Ctr. v. Shalala, 1 F.3d 522 (7th Cir. 1993).  Thus, while the Secretary may not seek to enforce the provisions of the SOM, he may seek to enforce the provisions of the Act or regulations as interpreted by the SOM.
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3. Scope and severity levels are used by CMS and a state when selecting remedies.  The scope and severity level is designated by an alpha character, A through L, selected by CMS or the state agency from the scope and severity matrix published in the SOM, ch. 7, § 7400.5.1 (rev. 63, Sep. 10, 2010).  A scope and severity level of A, B, or C indicates a deficiency that presents no actual harm but has the potential for minimal harm, which is an insufficient basis for imposing an enforcement remedy.  Facilities with deficiencies of a level no greater than C remain in substantial compliance.  42 C.F.R. § 488.301.  A scope and severity level of D, E, or F indicates a deficiency that presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy.  A scope and severity level of G, H, or I indicate a deficiency that involves actual harm that does not amount to immediate jeopardy.  Scope and severity levels J, K, and L indicate deficiencies that constitute immediate jeopardy to resident health or safety.  The matrix, which is based on 42 C.F.R. § 488.408, specifies which remedies are required and optional at each level based upon the frequency of the deficiency.
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4. SNFs and nursing facilities (NFs) are often referred to as long-term care facilities or nursing homes.  NF participation in Medicaid is governed by section 1919 of the Act.  Section 1919(h)(2) of the Act gives enforcement authority to the states to ensure that NFs comply with their participation requirements established by sections 1919(b), (c), and (d) of the Act.
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5. Congress granted the Secretary authority to impose enforcement remedies for noncompliance.  Act § 1819(h)(2).  The Secretary is authorized to impose CMPs as an enforcement remedy by section 1128A of the Act.  CMPs are imposed by CMS with delegated authority of the Secretary.  42 C.F.R. § 488.2.  Pursuant to subsection 1128A(j) of the Act, section 205 of the Act is applicable to the imposition of CMPs, and that section is applicable to the imposition of CMPs by both the Secretary and the Commissioner of Social Security under the authority of section 1128A of the Act.  The Inspectors General (IGs) for both HHS and the Social Security Administration (SSA) also exercise delegated authority to impose CMPs pursuant to section 1128A of the Act.  Both IGs engaged in rulemaking to specify the allocation of the burden of persuasion and the quantum of evidence required when proceeding upon a case involving a CMP.  Both the SSA IG and the HHS IG imposed upon the government in CMP cases the burden of persuasion on all issues other than affirmative defenses and mitigating factors for which the burden is upon the nongovernmental party.  The regulations of the IGs for SSA and HHS provide that the burden of persuasion is to be judged by a preponderance of the evidence.  20 C.F.R. § 498.215(b), (c); 42 C.F.R. § 1005.15(b), (d).  CMS failed to promulgate a regulation similar to those of the HHS and SSA IGs and the Board has filled the gap with its interpretative rules allocating the burden of persuasion to the nongovernmental party, the party defending against the imposition of the CMP.
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6. “Credible evidence” is evidence that is worthy of belief.  Black’s Law Dictionary 596 (8th ed. 2004).  The “weight of evidence” is the persuasiveness of some evidence compared to other evidence.  Id. at 1625.
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7. The CMS initial determination advised Petitioner that a DPNA would be effective March 28, 2018, and that Petitioner’s Medicare provider agreement would be terminated September 5, 2018, if Petitioner did not return to substantial compliance.  The parties do not mention either a DPNA or termination as an enforcement remedy imposed in this case and there is no evidence that either was imposed before Petitioner returned to substantial compliance.  I conclude that the only enforcement remedy at issue is the PICMP based on the alleged noncompliance under F700.  CMS also advised Petitioner that it may be ineligible to conduct a NATCEP.  However, Petitioner does not allege a right to hearing based on its ineligibility to be approved to conduct a NATCEP.  This decision resolves any issue related to NATCEP ineligibility because it is concluded that there is no basis for the imposition of a PICMP.
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8. Petitioner submitted the written direct testimony of three witnesses.  CMS waived the right to cross-examine the witnesses by agreeing to the waiver of oral hearing in this case.  Joint Motion for Waiver of Hearing and Request for Decision on the Written Record filed November 8, 2019.
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9. The four-inch gap that was measured by the surveyor was under the maximum gap recommended as safe by the FDA.  Arguably, if Resident 1’s mattress was moved completely to one side or the other, the gap could have been 12 inches.  Even if the gap was 12 inches, the decision in this case would be no different as the evidence shows that Resident 51 was incapable of placing himself at risk by rolling to one side or the other without the assistance of staff.
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10. I have only the surveyor’s summary of the FDA guidance in the SOD in evidence.  I note that the surveyor was clear that FDA recommendations are cited, rather than statutory or regulatory requirements.  However, the fact that Petitioner has adopted as a matter of policy the FDA recommendations is good evidence that those recommendations are consistent with the standard of care related to the use of bed rails.
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11. The better reading of 42 C.F.R. § 498.60(c)(2) is that the clearly erroneous standard only applies during ALJ review of the CMP, and that occurs only after it is determined that there is a basis for the imposition of an enforcement remedy.  The Board has been consistent in holding that Petitioner bears the burden to show it maintained substantial compliance by a preponderance of the evidence.  Petitioner meets its burden by rebutting the CMS prima facie case or establishing an affirmative defense.  Evergreene Nursing Care Ctr., DAB No. 2069 at 7.  Arguably, the preponderance of the evidence standard should apply to each element of the CMS prima facie case.  The scope of ALJ review specified by 42 C.F.R. § 498.60(c)(1) is set forth in 42 C.F.R. §§ 488.438(e) and 488.845(h) and both are clear that they apply to review of the reasonableness of the CMP, only after a basis for the imposition of an enforcement remedy is determined to exist.  Therefore, application of the clearly erroneous standard should only be applied in reviewing issues related to the CMS level of compliance determination in the context of ALJ review of the reasonableness of the CMP.
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