Montgomery County Nursing Home, DAB CR5884 (2021)

DECISION

Petitioner, Montgomery County Nursing Home, was not in substantial compliance with program participation requirements from March 1 through 23, 2017, due to a violation of 42 C.F.R. § 483.25(g)(2).1   There is a basis for the imposition of enforcement remedies.

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A civil money penalty (CMP) of $4,175 per day from March 1 through 23, 2017, for a total CMP of $96,025, is a reasonable enforcement remedy.

I.  Background

Petitioner is located in Mount Ida, Arkansas, and participates in Medicare as a skilled nursing facility (SNF) and the state Medicaid program as a nursing facility (NF).  On March 22 and 23, 2017, the Arkansas Department of Human Services Office of Long Term Care (state agency) conducted a complaint investigation and found Petitioner not in compliance with program participation requirements.  Joint Stipulations and Statement of Issues (Jt. Stip.) at 1; Centers for Medicare & Medicaid Services (CMS) Exhibits (Exs.) 1-3.  CMS notified Petitioner by letter dated April 17, 2017, that it was imposing the following enforcement remedies:  termination of Petitioner's Medicare and Medicaid provider agreement, unless Petitioner achieved substantial compliance before June 23, 2017; denial of payment  for new Medicare and Medicaid admissions (DPNA) effective April 21, 2017; and the imposition of a per-day CMP of $1,253 beginning March 2, 2017, until further notice.  CMS Ex. 2.  By letter dated June 8, 2017, CMS notified Petitioner that it rescinded the termination and the DPNA, and that it revised the per-day CMP to $4,175 per day from March 1 through March 23, 2017, for a total CMP of $96,025.  CMS Ex. 3 at 1.

Petitioner requested a hearing before an administrative law judge (ALJ) on July 5, 2017 (RFH).  On July 14, 2017, the case was assigned to me for hearing and decision, and an Acknowledgement and Prehearing Order was issued at my direction.  On July 23, 2019, a hearing was convened and a transcript (Tr.) of the proceedings was prepared.  CMS offered CMS Exs. 1 through 10 and Petitioner offered Petitioner exhibits (P. Exs.) 1 through 5, all of which were admitted as evidence.  Tr. 27.  CMS called the following witnesses:  Elise Foard, BSN and Janice Myers-Robison, RN.  Petitioner called the following witnesses:  Janet Weston, LPN; Sherri Sanders, RN; Ola Marie Anderson, Petitioner's certified dietary manager; Pam Loomis, RN, Petitioner's Director of Nursing (DON); and Tabitha Lancaster, RN.

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The parties filed post-hearing briefs (CMS Br. and P. Br., respectively) and reply briefs (CMS Reply and P. Reply, respectively).

II.  Discussion

A.  Issues

The issues in this case are:

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

Whether the enforcement remedy proposed is reasonable.

B.  Applicable Law

The statutory and regulatory requirements for participation of a SNF in Medicare are at section 1819 of the Social Security Act (Act) and at 42 C.F.R. pt. 483.  Section 1819(h)(2) of the Act authorizes the Secretary 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.2   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 the date noncompliance began.  Act § 1819(h)(2)(C).  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 the date noncompliance began – commonly referred to as the mandatory or statutory 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 180 days of noncompliance.  The Act also grants the Secretary authority to impose other enforcement remedies, including a discretionary DPNA, CMPs, appointment of temporary management, and other remedies such as a directed plan of correction.  Act § 1819(h)(2)(B).

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The Secretary has delegated to CMS and the states the authority to impose remedies against a long-term care facility that is not complying substantially with federal participation requirements.  "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.  Noncompliance refers to any deficiency (statutory or regulatory violation) that causes a facility not to be in substantial compliance, i.e., 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.  The regulations specify that a CMP that is imposed against a facility on a per day basis will fall into one of two ranges of penalties.  42 C.F.R. §§ 488.408, 488.438.  The upper range of CMPs, $6,394 per day to $20,965 per day, is reserved for deficiencies that pose immediate jeopardy to a facility's residents and, in some circumstances, for repeated deficiencies.  42 C.F.R. § 488.438(a)(1)(i), (d)(2); 45 C.F.R. § 102.3 (Table).  "Immediate jeopardy means a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident."  42 C.F.R. § 488.301 (emphasis in original).  The lower range of CMPs, $105 per day to $6,289 per day, is reserved for deficiencies that do not pose immediate jeopardy, but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm.  42 C.F.R. § 488.438(a)(1)(ii); 45 C.F.R. § 102.3 (Table).  The Act and regulations make a hearing before an ALJ available to a long-term care facility 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 would impact the facility's authority to conduct a nurse aide training and competency evaluation program (NATCEP).  42 C.F.R. § 498.3(b)(14),

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(d)(10)(i).  The CMS determination as to the level of noncompliance "must be upheld unless it is clearly erroneous."  42 C.F.R. § 498.60(c)(2); Woodstock Care Ctr., DAB No. 1726 at 9 (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).

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 persuasion and the quantum of evidence required to meet the burden is not addressed by regulations.3   Rather, the Board has long held that the petitioner, the nongovernmental party, bears the 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

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(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 only when CMS makes a prima facie showing of noncompliance, is the facility burdened to show, by a preponderance of the evidence on the record as a whole, that it was in substantial compliance or had an affirmative defense.  Evergreene Nursing Care Ctr., DAB No. 2069 at 7 (2007).  The Board has not specified how much 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 a prima 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, that is, CMS should be burdened to present evidence sufficient to establish a fact as more likely true and to raise a presumption.  However, the Board has never ruled that CMS must establish its prima facie case by a preponderance of the evidence.  Indeed, 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, I conclude that CMS has made its prima facie showing 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.4   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., Admin. Law & Prac. § 5:64 (3d ed. 2013).

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The surveyors allege under Tag F3275 in the statement of deficiencies (SOD) for the complaint investigation completed on March 23, 2017, that Petitioner violated 42 C.F.R. § 483.25(g)(2) and the violation caused actual harm (scope and severity level H6 ) to

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Resident 1.  The surveyors specifically allege that Petitioner "failed to ensure sufficient fluids were provided to prevent dehydration for 1 (Resident #1) and failed to ensure hydration status and fluid intake were consistently and thoroughly assessed, monitored and documented to prevent actual or potential dehydration" for Resident 1 and other residents, including Residents 3, 4, and 5.  CMS Ex. 1 at 2.  The surveyors allege that Resident 1 suffered actual harm because he was hospitalized with severe dehydration and acute renal failure.  The surveyors allege 59 other residents, including Residents 3, 4, and 5, were at risk for more than minimal harm due to Petitioner's noncompliance with 42 C.F.R. § 483.25(g)(2).  CMS Ex. 1 at 2.

CMS alleges that Petitioner was not in substantial compliance with program participation requirements from March 1 through 23, 2017, based upon a violation of 42 C.F.R. § 483.25(g)(2).  CMS Exs. 2-4.  CMS's argument is that Petitioner failed to provide Resident 1 the amount of fluids Petitioner assessed that he needed in order to maintain hydration and health.  Regarding the other residents cited as examples in the SOD, the CMS argument is that they were assessed as at risk for dehydration and, in addition to failing to ensure that those residents were offered adequate fluids, Petitioner should have implemented the intervention of tracking intake and output of fluids in order to identify if the residents were becoming dehydrated.  CMS Reply at 1, 4; Tr. 34.  The example of Resident 1 establishes noncompliance with 42 C.F.R. § 483.25(g)(2) that caused actual harm and is a sufficient basis for the imposition of the CMP proposed in this case.  Therefore, there is no need to address in detail the examples cited related to Residents 3, 4, and 5, except in the context of the scope and severity determination.

Petitioner argues that Resident 1 was offered fluids each day in excess of what his care plan required.  Petitioner does not deny that when Resident 1 was admitted to the hospital he was dehydrated but argues the dehydration was due to his acute renal failure, not the failure of Petitioner to offer him sufficient fluids.  P. Br. at 8-9; P. Reply at 7.

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1.  Petitioner violated 42 C.F.R. § 483.25(g)(2) as alleged under Tag F327.

2.  The violation of 42 C.F.R. § 483.25(g)(2) posed a risk for more than minimal harm. 

a.  Facts

Resident 1 was admitted to Petitioner on February 15, 2017.  He was 80 years old when admitted.  CMS Ex. 6 at 1; P. Ex. 1 at 5, 9.  He was always incontinent of bowel and bladder.  His diagnoses included:  a history of cancer, anemia, coronary artery disease, heart failure, hypertension, gastroesophageal reflux disease, diabetes mellitus, hyperlipidemia, history of cerebrovascular accident, asthma, respiratory failure, history of myocardial infarction, aspiration pneumonia, muscle weakness, hypokalemia, nutritional deficiency, polyneuropathy, extrapyramidal and movement disorder, pain, and constipation.  CMS Ex. 6 at 4-5; P. Ex. 1 at 6-7, 11.  He was assessed as requiring setup help and supervision with eating, including oversight, encouragement, or cueing.  CMS Ex. 6 at 3; P. Ex. 1 at 6, 11.  Resident 1 was also assessed as having a swallowing disorder.  CMS Ex. 6 at 5, 12; P. Ex. 1 at 137.  He was prescribed a diuretic, among other medications.  CMS Ex. 6 at 6; P. Ex. 1 at 7, 12.  He was assessed as requiring a nutritional assessment plan.  CMS Ex. 6 at 7.

A dietary assessment was completed for Resident 1 on February 16, 2017.  Petitioner's dietary manager, Ola Marie Anderson, assessed the resident as requiring 2672 milliliters (ml) of fluid daily.  P. Ex. 1 at 131.  Therefore, Resident 1 required approximately 90.848 US fluid ounces of fluids each day according to the dietician's calculations.7   However, both CMS and Petitioner converted 2672 ml to 89 ounces.  CMS Br. at 1, 4, 6; P. Br. at 3.  The 1.848 fluid ounce difference between 89 and 90.848 has no impact on the outcome in this case and, therefore, I use the 89 ounces as Resident 1's daily fluid requirement.  There is no dispute that Petitioner did not record on a document the amount of fluid offered to Resident 1 each day.  CMS Br. at 7; P. Br. at 15-16; Tr. 134, 155, 167.  Petitioner's position is that monitoring of fluid intake is not required under the

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regulations or standard of practice, unless ordered by a physician, and there is no dispute that there was no physician order for monitoring Resident 1's fluid intake.  Tr. 14-15.

There is no dispute that on March 2, 2017, Resident 1 was admitted to the hospital from Petitioner.  He was assessed as suffering severe dehydration and acute renal failure, among other things.  CMS Ex. 6 at 23, 79; CMS Ex. 7 at 3-4, 6-7; P. Ex. 1 at 27, 112-15, 117-19; Tr. 64.

Nursing notes from February 15 to March 2, 2017, record that Resident 1 had either nectar thickened liquids or water at his bedside.  The notes do not indicate the size of the container or the amount of fluid or how often the fluids were replenished.  Notes also show that Resident 1 received a supplement on some days.  CMS Ex. 6 at 30, 32, 34, 37, 40-41, 44-45, 48, 50, 53-54, 56-57, 59, 62-63, 65-66, 69-70, 72-73, 75-76, 78.  Physician orders indicate that the supplement was mixed with a liquid of choice.  P. Ex. 1 at 23, 32.  The evidence does not show how many fluid ounces were required for mixing with the supplement or that fluids separate from those provided in Resident 1's room or with his meals were used.

Petitioner placed in evidence Resident 1's nutrition care plan.  P. Ex. 1 at 17.  But that plan does not specifically address hydration and Petitioner offered no evidence that there was a hydration care plan.  Tr. 42, 187.

P. Ex. 1 at 126, which appears to be a meal card, lists 240 cubic centimeters (cc) of milk and 2 to 4 ounces of thickened juice for breakfast, 10 ounces of thickened tea for lunch, and 240 cc of milk and 2 to 4 ounces of thickened juice for dinner.  P. Ex. 1 at 128 shows that one ounce is equivalent to 30 cc, so 240 cc is equivalent to approximately 8 ounces of fluid.  Therefore, if the meal card was for Resident 1, and I infer it was as there was no question raised as to its relevance or authenticity when placed in evidence by Petitioner, the meal card only listed a total amount of fluid for all three daily meals of 30 to 34 ounces.

P. Ex. 1 at 155, an unsworn statement of Pam Loomis, RN, Petitioner's DON, states that two different size cups were used for fluids for medication passes, a five-ounce and a nine‑ounce cup.

P. Ex. 1 at 156 is an unsworn statement signed by Tommy Johnston, Petitioner's Administrator, and DON Loomis explaining that fluids were provided to residents.  The statement indicates that fresh ice water was placed in resident rooms three times per day.  The statement indicates that before the survey a 20-ounce pitcher was used and after the survey a 16-ounce pitcher was used.  The statement does not address whether the practice applied to Resident 1's thickened liquids.  However, the statement indicates that the practice did not apply to a resident who had a fluid restriction without clarifying whether the requirement for only thickened liquids was considered a fluid restriction.  The

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statement also indicates that residents were provided soft drinks, juices, or other fluid during a medication pass without indicating whether the fluid used at a medication pass was separate from the fluid already in the resident's room.

LPN Weston testified that she took care of Resident 1 during the day shift, 7:00 a.m. to 3:00 p.m., while he was a resident.  She testified that she offered Resident 1 fluids during medication passes, morning and afternoon, without indicating whether she used the fluid already in the resident's room or from another source.  She also saw Resident 1 during the morning and afternoon and offered him fluids, also without indicating where she obtained the fluids.  She testified that Resident 1 always had a 16-ounce glass of thickened liquid at his bedside with a straw in it.  LPN Weston did not testify to the volume of fluids she offered or how often the 16-ounce glass at his bedside was refilled during a shift.  Tr. 126-30.  On cross-examination she testified that she probably offered Resident 1 a five-ounce glass of fluid when she did a medication pass without indicating where she obtained the fluid.  Tr. 134.

RN Sanders testified that she took care of Resident 1 during the night shift, 8:30 p.m. to 7:00 a.m., while he was a resident.  She usually saw Resident 1 for his 6:00 a.m. medication pass and as needed.  She offered Resident 1 fluids with his medications from the container in his room, which was usually half or less full.  He usually required several drinks to get his medication down.  RN Sanders testified that the cup at Resident 1's bedside was an eight-ounce cup.  She explained that when a resident requires thickened liquids, it is always in an eight-ounce cup and the resident does not have a water pitcher at bedside.  Tr. 140-43.

Petitioner's dietary manager for 12 years, Ms. Anderson, testified that she is a licensed certified dietary manager.  Tr. 148.  She testified that she interviewed Resident 1 to determine his preference for fluids.  She calculated he needed 89 ounces of fluid per day and divided that by three meals per day, and the fluid was delivered to him on his breakfast, lunch, and dinner meal trays daily.  She testified that Resident 1 could ask for any additional fluids he wanted without charge.  Tr. 152-57.

DON Loomis testified generally as to how and when fluids were offered to Petitioner's residents without addressing specifically the case of residents who require thickened liquids such as Resident 1.  She testified that Petitioner's certified nurse assistants (CNAs) deliver water to resident rooms every day.  The daily requirement for fluids is divided by three meals, and the fluid is placed on each resident's meal tray.  Residents are also given fluids with their medications and after toileting.  Fluids are offered during restorative care and activities.  CNAs also offer residents fluid during nighttime checks and turning of residents.  DON Loomis testified that fresh nectar thickened fluids are placed in resident rooms each shift for residents who require thickened fluids.  She could not specifically recall the size of the cup used but testified she knew that they had both five-ounce and eight-ounce cups, and she thought eight ounces was probably the size

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used.  She testified that Resident 1 could have been offered fluids more than six times per day.  Tr. 161-66.

RN Lancaster, a nurse consultant, was called by Petitioner and qualified as an expert to render opinions related to the standard of practice for skilled nursing facilities.  Tr. 176-81.  She testified that the standard of practice for long-term care facilities is to track fluids when ordered by a physician and that typically occurs for residents on renal dialysis, receiving intravenous fluids, or receiving gastrostomy tube feeding.  She testified that monitoring generally does not involve tracking the specific amount of fluid, but rather, is done more generally, e.g., a resident drank a half-glass of water, or the pitcher is empty and was filled.  Tr. 183-84.  RN Lancaster testified that treatment records for the period February 15 to March 2, 2017 (P. Ex. 1 at 43-44) show Resident 1 had a "significant, probably more than normal fluid output."  However, the treatment record appears to record the frequency of urination not the amount of urine produced.  Therefore, RN Lancaster's opinion that Resident 1 had a higher than normal fluid output, at least to the extent she is implying Resident 1 must have had a higher than normal fluid intake, is not based on fact and is not accepted as weighty.  Tr. 185-86.  RN Lancaster also opined that Resident 1's dehydration was caused by his acute renal failure.  Tr. 192.  I find that opinion is beyond the scope of RN Lancaster's expertise as no evidence was presented that she was authorized under her state license to render diagnoses or that she had any experience in the areas of nephrology or kidney disease.  She opined that Petitioner ensured that Resident 1 was offered sufficient fluids for hydration.  However, that opinion is not supported by the evidence as discussed hereafter and is not accepted as weighty.

b.  Analysis

"Quality of care is a fundamental principle that applies to all treatment and care provided to facility residents."  42 C.F.R. § 483.25.  Petitioner must ensure that, "[b]ased on the comprehensive assessment of a resident . . . residents [sic] receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the resident's choices."  Id.  The specific quality of care requirement at issue in this case is 42 C.F.R. § 483.25(g)(2), which requires that Petitioner ensure that a resident "[i]s offered sufficient fluid intake to maintain proper hydration and health."  42 C.F.R. § 483.25(g)(2).

The drafters of 42 C.F.R. § 483.25(g)(2) explained that the new regulation requires that a facility not simply provide hydration by placing fluid in a resident's room.  The facility must offer fluids to a resident.  The drafters of the regulation stated:

This change was proposed in response to anecdotal accounts of fluids being placed in a resident room without ensuring that the resident was actually able to drink them. While

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residents' [sic] have the right to refuse to drink the fluids, it is not enough for a facility to simply place fluids in a resident room. We would expect that the fluids actually be offered to the resident and assistance provided so that the resident can drink, if they so desire.

81 Fed. Reg. 68,688, 68,751 .

The Board has addressed various issues related to the hydration requirement that are pertinent to both the old and new regulations.  The Board has found that a diagnosis of dehydration upon admission to a hospital from a facility is sufficient to establish the CMS prima facie case of a violation of the hydration requirement.  Woodland Vill. Nursing Ctr, DAB No. 2053 (2006), aff'd, Woodland Vill. Nursing Ctr. v. U.S. Dep't of Health & Human Servs., 239 F. App'x 80 (5th Cir. 2007).  If CMS makes a prima facie showing, the burden is upon a petitioner to show by a preponderance of the evidence that it complied with the regulatory requirement.  Specifically, a petitioner must show it took adequate steps based on the resident's comprehensive assessment, professional standards of practice, the resident's care plan, and the resident's preferences, to ensure the resident was offered adequate hydration to maintain proper hydration and health.  Cmty. Skilled Nursing Ctr., DAB No. 1987 at 16 (2005) (facility had burden to show that the resident "became dehydrated despite care that was consistent with professional standards of quality for preventing dehydration in someone of [the resident's] condition").  The regulatory requirement to offer adequate hydration does not state that it is limited to only residents who are assessed as at risk for dehydration.  All residents must be offered adequate hydration which they can ingest or otherwise receive so that they can maintain hydration and good health.

The Board has consistently held that section 1819(b) of the Act and the Secretary's regulations are based on the premise that a facility has the expertise to plan for and provide care and services to maintain a resident's highest practicable functional level.  Woodland Vill. Nursing , DAB No. 2053 at 8-9 (citing Spring Meadows Health Care Ctr., DAB No. 1966 at 20 (2005)) ("[w]hen a facility adopts a policy that calls on the nursing staff to take affirmative actions to safeguard resident health and safety, it is reasonable to infer (in the absence of evidence to the contrary) that the facility did so because such actions are necessary to attain or maintain resident well-being.").  The Board has also held that a facility's failure to comply with a physician's orders or to follow its own facility policy, as well as a facility's failure to provide services in accordance with a resident's plan of care based on a resident's comprehensive assessment, can constitute a deficiency under section 483.25.  Lakeridge Villa Health Care Ctr., DAB No. 1988 at 22 (2005) (citing The Windsor House, DAB No. 1942 at 55‑56 (2004) (emphasis added); Batavia Nursing & Convalescent Ctr., DAB No. 1904 at 35-36 (2004)).

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There is no dispute that on March 2, 2017, Resident 1 was admitted to the hospital from Petitioner.  Resident 1 was determined to be suffering dehydration upon admission to the hospital.  Based on the Board's persuasive analysis in Woodland Vill. Nursing , I conclude CMS has made a prima facie showing that Petitioner violated the requirement of 42 C.F.R. § 483.25(g)(2) to ensure that Resident 1 was offered sufficient fluids to maintain proper hydration and health.  CMS does not have the burden to establish by other evidence that Resident 1 was offered insufficient fluids.

Therefore, the burden is upon Petitioner to establish by a preponderance of the evidence that it did offer Resident 1 sufficient fluids to maintain proper hydration and health.  I conclude Petitioner failed to satisfy its burden because Petitioner has failed to present credible evidence that it provided Resident 1 the 89 fluid ounces of liquid per day that Petitioner's dietary manager determined Resident 1 required.

The evidence is inconsistent on whether Petitioner ensured Resident 1 was offered sufficient fluids.

Petitioner's dietary manager, Ms. Anderson, determined that Resident 1 required 2672 ml of fluid daily for proper hydration as part of his nutrition assessment, which was part of his comprehensive assessment, and his nutrition care plan.  P. Ex. 1 at 131; Tr. 152-57.  There is no issue raised by the parties as to whether the dietary manager used the correct formula to determine Resident 1's daily fluid needs.  P. Br. at 11.  Ms. Anderson testified that she divided 89 ounces of fluid among Resident 1's three meals, breakfast, lunch, and dinner.  Tr. 152-57.  However, Ms. Anderson's testimony is inconsistent with P. Ex. 1 at 126.  P. Ex. 1 at 126 is a meal card for Resident 1 with handwriting that lists 240 cc of milk and 2 to 4 ounces of thickened juice for breakfast, 10 ounces of thickened tea for lunch, and 240 cc of milk and 2 to 4 ounces of thickened juice for dinner.  P. Ex. 1 at 128 shows that one ounce is equivalent to 30 cc, so 240 cc is equivalent to approximately 8 ounces of fluid.  Therefore, if the meal card was for Resident 1, and I infer it was as there was no question raised as to its relevance or authenticity, the meal card only listed a total amount of fluid for all three daily meals of 30 to 34 ounces.  Therefore, I cannot credit Ms. Anderson's testimony that Resident 1 was offered all 89 fluid ounces that he required at his three meals.  Based on the same reasoning, I also cannot credit DON Loomis' testimony that all of a resident's fluid requirements were provided to him or her during his or her daily meals.  Tr. 161-66.

Whether or not Resident 1 was offered his remaining fluid requirement of 55 to 59 fluid ounces per day is also subject to conflicting evidence.

The unsworn statement of Petitioner's Administrator and DON indicates that fresh water was placed in resident rooms three times per day and that a 20-ounce pitcher was used prior to the survey.  P. Ex. 1 at 156.  The statement suggests that Resident 1 had 60 ounces of fluid placed in his room three times per day.  LPN Weston testified that she

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took care of Resident 1 during the day shift; he was offered fluids with medication passes during the morning and afternoon; and he always had a 16-ounce glass of thickened fluid at his bedside with a straw in it.  LPN Weston testified that she probably offered Resident 1 a five-ounce glass of fluid with medications.  Tr. 126-30, 134.  She did not testify as to how often the 16-ounce glass was replenished.  LPN Weston's testimony that Resident 1 had a 16-ounce glass of fluid at his bedside is inconsistent with the statement of Petitioner's Administrator and DON that a 20-ounce pitcher was used in resident rooms.  RN Sanders testified that she took care of Resident 1 during the night shift.  She testified that with Resident 1's 6 a.m. medication pass, she offered him fluid from the container in his room which was an eight-ounce cup.  She explained that residents who required thickened liquids always received the thickened water in their room in an eight-ounce cup and no water pitcher was placed at bedside.  Tr. 140-43.  RN Sanders' testimony that an eight-ounce cup was used for thickened liquid and that is what she used for Resident 1 at the medication pass is consistent with the resident's fluid restriction to thickened liquids.  Nursing notes that indicate that Resident 1 may have had un-thickened water at his bedside (CMS Ex. 6 at 30, 32, 34, 37, 40-41, 44-45, 48, 50, 53-54, 56-57, 59, 62-63, 65-66, 69-70, 72-73, 75-76, 78) are inconsistent with the resident's restriction to thickened liquids.  DON Loomis indicates in an unsworn statement placed in evidence by Petitioner that two sizes of cups were used for medication passes, a five-ounce cup and a nine-ounce cup.  P. Ex. 1 at 155.  To the extent that DON Loomis' statement is construed to be that Resident 1 was offered fluid in a five or nine-ounce cup at a medication pass, this is inconsistent with RN Sanders' testimony that thickened liquids came in an eight-ounce cup.  RN Sanders' testimony that she used the thickened liquid already in Resident 1's room to help him swallow his medications is also credible.  LPN Weston's testimony that Resident 1 always had a 16-ounce glass of thickened liquids at his bedside is inconsistent with RN Sanders' testimony that the cup at Resident 1's bedside was an eight-ounce cup because an eight-ounce cup is used for thickened liquids.  DON Loomis testified that when thickened fluids are required, they are placed in a resident's room each shift; she knew both five-ounce and eight-ounce cups were used; and she thought the eight-ounce cup was the one most likely used.  She also testified that Resident 1 could have been offered fluids more than six times per day, but she did not testify that he was.  Tr. 161-66.

The evidence, while conflicting, arguably supports a finding that in addition to the 30 to 34 ounces of fluid offered Resident 1 during meals, he may have been offered five ounces of fluid with his two medication passes by LPN Weston and he may have received eight ounces of fluid each shift delivered by CNAs.  Therefore, Resident 1 could have received 10 ounces of fluid with medication passes, 24 ounces during each shift delivered by CNAs, and 34 ounces of fluids with meals, for a total of only 68 ounces of fluids each day – 21 ounces less than Resident 1's nutrition care plan required each day.  The evidence fails to show it was more likely than not that on a regular daily basis Resident 1 was offered more than 68 fluid ounces.  A finding that Resident 1 was offered more than 68 fluid ounces per day is purely speculative given the evidence of record.

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I conclude Petitioner has failed to establish by a preponderance of the evidence that it offered Resident 1 adequate fluids and that it was in compliance with the requirement of 42 C.F.R. § 483.25(g)(2).

Resident 1 suffered severe dehydration.  Petitioner has not rebutted by a preponderance of the evidence that the dehydration was due to its failure to provide adequate fluids.  Resident 1's dehydration and hospitalization were actual harm.

This decision should not be read to impose or suggest a requirement that fluid intake and output for all residents must be tracked.  However, facilities must always be cognizant that they must prove their compliance with statutory and regulatory participation requirements. 

3.  A CMP of $4,175 per day from March 1 through 23, 2017, for a total CMP of $96,025, is a reasonable enforcement remedy. 

CMS imposed a CMP of $4,175 per day from March 1 through 23, 2017, for a total CMP of $96,025.  CMS Exs. 3, 4.  Petitioner argues that the scope and severity designation at level H and the amount and duration of the CMP imposed are unreasonable, and that the CMP should be lowered as a result.  RFH at 2; P. Br. at 16.  Petitioner first argues that the facts do not support a scope and severity designation at level H and there was no actual harm or potential for actual harm to any residents, and specifically with respect to Resident 1.  RFH at 2.  Petitioner next argues that there is no evidence of a pattern of noncompliance to support a scope and severity level of H and that Petitioner offered sufficient fluids to Resident 1.  P. Br. at 16.  Finally, Petitioner argues that the duration of the CMP is unreasonable because the duration exceeds the time that Resident 1 was a resident of Petitioner's facility.  P. Br. at 16.

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 result “in the loss of approval of” a NATCEP offered by Petitioner.  42 C.F.R. § 498.3(b)(14), (b)(16), (d)(10)(i).  In this case, the authorized and proposed CMP was in the lower range and there was no declaration of immediate jeopardy that would have permitted a CMP in the higher range.  Therefore, no challenge by Petitioner can affect the range of the authorized CMP.  The regulations, 42 C.F.R. § 498.3(b)(14)(ii) and (b)(16), are also very specific that the level of noncompliance may be challenged only when a finding of substandard quality of care actually results in the loss of approval of a NATCEP, not just the ineligibility to conduct a NATCEP.  In this case, there is no evidence Petitioner was conducting a NATCEP.  Accordingly, the scope and severity level of noncompliance in this case is not reviewable.

Even if scope and severity was subject to review, the CMS determination as to the level of noncompliance “must be upheld unless it is clearly erroneous.”  42 C.F.R.

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§ 498.60(c)(2); Woodstock, DAB No. 1726 at 9.  Petitioner has not shown that the scope and severity determination was clearly erroneous.  Resident 1 suffered actual harm and Petitioner has not shown that its noncompliance did not pose a risk for multiple  residents who may not have been offered sufficient fluids to maintain hydration and health.  Petitioner argues that the surveyors conceded at hearing that they identified no evidence that Residents 3, 4, and 5, the other examples cited in the SOD, were not “receiving sufficient fluids.”  P. Br. at 16.  Petitioner’s argument, however, misses the mark.  The CMS arguments are that Petitioner has not offered evidence it was offering Residents 3, 4, and 5 sufficient fluids; and that those residents were assessed by Petitioner as at risk for dehydration but Petitioner had no specific plan to address the residents’ assessed risk for dehydration.  CMS Reply at 5.  Petitioner has not presented evidence as to how much fluid was actually offered Residents 3, 4, and 5, or care plans to address their assessed risk for dehydration.  Accordingly, I cannot conclude that the scope and severity determination was clearly erroneous, if it is reviewed.

Petitioner argues that the CMP is unreasonable because the duration exceeds the period of Resident 1's stay at Petitioner.  RFH; P. Br. at 16.  The duration of remedies is governed by 42 C.F.R. § 488.454.  Generally, under the regulations, noncompliance and remedies imposed based on that noncompliance continue until CMS determines the facility has achieved substantial compliance based upon a revisit survey or credible written evidence, or it terminates a facility's provider agreement.  42 C.F.R. § 488.454(a)(1), (e).  Once CMS determines a SNF is noncompliant with the Medicare requirements, there is a rebuttable presumption that the noncompliance continues.  Crawford Healthcare & Rehab., DAB No. 2738 at 14 (2016).  Petitioner has the burden of showing it corrected the conditions that caused the noncompliance and that it returned to substantial compliance on a date earlier than that determined by CMS.  Putnam Ctr., DAB No. 2850 at 28 (2018), aff'd, Putnam Ctr. v. HHS, 770 F. App'x 630 (4th Cir. 2019).

In this case, Petitioner has failed to show that it corrected the conditions that caused the noncompliance and that it returned to substantial compliance before March 23, 2017.  The fact that Resident 1 departed Petitioner on March 2, 2017, and did not return, did not correct the noncompliance.  Petitioner presented no evidence for my consideration that prior to March 23, 2017, it had a plan to ensure it met the requirement of 42 C.F.R. § 483.25(g)(2) to ensure its residents were offered adequate fluids to maintain hydration and health.  The CMP in this case accrued from March 1 through 23, 2017.  CMS Ex. 3 at 1.  Petitioner argues that Resident 1 was admitted to the hospital on March 2, 2017, and that the noncompliance must have ended on that date.  However, I find that simply removing residents who sustain actual harm from the facility is insufficient to return to compliance or to demonstrate compliance at an earlier date, particularly when the SOD identified 59 residents who were at risk for more than minimal harm due to Petitioner's failed hydration practices.  CMS Ex. 1 at 2.  Petitioner's failure to ensure that Resident 1 was offered adequate fluids for hydration and health demonstrates a systemic failure to

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comply with 42 C.F.R. § 483.25(g)(2).  This was not resolved just because Resident 1 was no longer physically present in the facility.  Petitioner has presented no evidence to demonstrate that it corrected its noncompliance before March 23, 2017, such as a plan of correction and evidence that it completed all of the corrective actions at an earlier date; that it had retrained its entire staff on hydration practices; that it began intake and output monitoring for its residents; or that it implemented other appropriate measures to ensure that similar incidents would not recur.  Petitioner has not met its burden to rebut the presumption that noncompliance continued through March 23, 2017.  Accordingly, the accrual of the CMP from March 1 through 23, 2017, is reasonable.

My authority to review the reasonableness of the CMP is limited by 42 C.F.R. § 488.438(e).  The limitations are:  (1) I may not set the CMP at zero or reduce it to zero; (2) I may not review the exercise of discretion by CMS in selecting to impose a CMP; and (3) I may only consider the factors specified by 42 C.F.R. § 488.438(f) when determining the reasonableness of the CMP amount.  In determining whether the amount of a CMP is reasonable, the following factors specified at 42 C.F.R. § 488.438(f) must be considered:  (1) the facility's history of noncompliance, including repeated deficiencies; (2) the facility's financial condition; (3) the seriousness of the deficiencies as set forth at 42 C.F.R. § 488.404(b), the same factors CMS and/or the state were to consider when setting the CMP amount; and (4) the facility's degree of culpability, including, but not limited to, the facility's neglect, indifference, or disregard for resident care, comfort, and safety.  The absence of culpability is not a mitigating factor.  42 C.F.R. § 488.438(f)(4).  The factors that CMS and the state were required to consider when setting the CMP amount and that I am required to consider when assessing the reasonableness of the amount are set forth in 42 C.F.R. § 488.404(b):  (1) whether the deficiencies caused no actual harm but had the potential for minimal harm, no actual harm with the potential for more than minimal harm, but not immediate jeopardy, actual harm that is not immediate jeopardy, or immediate jeopardy to resident health and safety; and (2) whether the deficiencies are isolated, constitute a pattern, or are widespread.  My review of the reasonableness of the CMP is de novo and based upon the evidence in the record before me.  I am not bound to defer to the CMS determination of the reasonable amount of the CMP to impose, but my authority is limited by regulation as already explained.  I am to determine whether the amount of any CMP proposed is within reasonable bounds considering the purpose of the Act and regulations.  Emerald Oaks, DAB No. 1800 at 10 (2001); CarePlex of Silver Spring, DAB No. 1683 at 14–16 (1999); Capitol Hill Cmty. Rehab. & Specialty Care Ctr., DAB No. 1629 (1997).

I have concluded that Petitioner violated 42 C.F.R. § 483.25(g)(2) and that the violation resulted in actual harm to Resident 1.  CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, including a CMP.  CMS may impose a per-day CMP for the number of days that the facility is not in compliance.  42 C.F.R. § 488.430(a).  The lower range of authorized CMPs, $105 per day to $6,289 per day, is reserved for deficiencies that do not pose immediate jeopardy, but either cause

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actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm.  42 C.F.R. § 488.438(a)(1)(ii); 45 C.F.R. § 102.3 (Table).  Therefore, the lower range of CMPs applies in this case.  The proposed per day CMP of $4,175 falls in the upper half of the lower range of authorized CMPs.

I have concluded that Petitioner violated 42 C.F.R. § 483.25(g)(2), which caused actual harm to Resident 1.  I have received no evidence showing that Petitioner had a history of noncompliance.  Petitioner has not alleged it is unable to pay the proposed CMP.  Petitioner's failure to comply with 42 C.F.R. § 483.25(g)(2) had the potential to affect multiple residents, involved multiple staff and, therefore, constituted a pattern of noncompliance.  Petitioner was culpable.  Because Petitioner neglected to ensure Resident 1 was offered sufficient fluids daily to maintain proper hydration and health, he suffered actual harm in the form of dehydration and hospitalization.

I conclude that there is a basis for the imposition of a per-day CMP in this case.  I conclude that the CMP of $4,175 per day proposed by CMS for the period of noncompliance from March 1 through 23, 2017, is reasonable.

III.  Conclusion

For the foregoing reasons, I conclude that Petitioner violated 42 C.F.R. § 483.25(g)(2) and the violation posed a risk for more than minimal harm.  A CMP of $4,175 per day from March 1 through 23, 2017, is reasonable.

• 1. References are to the Code of Federal Regulations (C.F.R.) as revised effective November 28, 2016, unless otherwise indicated.  81 Fed. Reg. 68,688, 68,697 (Oct. 4, 2016).  In Mark A. Kabat, D.O., DAB No. 2875 at 9-11 (2018), an appellate panel of the Departmental Appeals Board (Board), after reviewing prior Board decisions, expressed a preference for applying the regulations in effect at the time of the agency action rather than at the time of the events that were the basis for the agency action, at least in provider and supplier revocation cases.  Other appellate panels of the Board have concluded it is appropriate in long-term care facility survey cases to apply the revision of the regulatory participation requirements in the revision of the C.F.R. in effect at the time a survey was conducted.  Good Shepherd Home for the Aged, Inc., DAB No. 2858 at 1 n.1 (2018); Carmel Convalescent Hosp., DAB No. 1584 at 2 n.2 (1996).  In this case, the survey was completed on March 23, 2017, and the CMS initial determination was issued on April 17, 2017.  The regulations to which Petitioner was bound to comply during this period were in the 2016 revision of the C.F.R. as amended effective November 28, 2016.  The November 28, 2016 revision of 42 C.F.R. pt. 483 resulted in many of the participation requirements established by the regulations being moved and renumbered.  81 Fed. Reg. 68,688, 68,697.  I conclude that the new regulations effective November 28, 2016, apply under the Board's rationale in Good Shepherd, Carmel, and the cases cited therein.  The new regulations were first published in the 2017 revision of the C.F.R.
• 2. SNFs and NFs are often referred to as long-term care facilities or nursing homes.  Participation of a NF 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.
• 3. 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.
• 4. "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.
• 5. 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 (http://www.cms.hhs.gov/Manuals/IOM/list.asp).  The "Tag" refers to the specific regulatory provision allegedly violated and CMS's policy guidance to surveyors for identifying compliance or noncompliance.  The SOM is not promulgated in accordance with section 1871(a)(1)‑(2) of the Act and does not have the force and effect of law.  Azar v. Allina Health Servs., 588 U.S. __, 139 S. Ct. 1804 (2019).  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.  Indiana Dep't. of Pub. Welfare v. Sullivan, 934 F.2d 853 (7th Cir. 1991); Northwest 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.
  
  As already noted, CMS extensively revised the regulatory participation requirements in 42 C.F.R. pt. 483, effective November 28, 2016.  81 Fed. Reg. 68,688, 68,697.  However, CMS did not issue its revised SOM, app. PP – Guidance to Surveyors for Long Term Care Facilities (available at www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs) that addressed the revised regulations until November 22, 2017 (SOM, rev. 173, eff. Nov. 22, 2017).  The revised SOM changed the numbering of the F-Tags.  Therefore, when the surveyors conducted the survey in this case, the SOM available to the surveyors for guidance did not correlate to the new regulations.  In the SOD, the surveyors cite the new regulation under F Tag 327 from the old SOM (rev. 168, eff. Mar. 8, 2017).  Tr. 31-33, 36.  Although confusing, I concluded it was unnecessary to send this case back to CMS for correction of the SOD to refer to the new F-Tag from the revised SOM as there is no substantive impact in deciding this case.  Whether or not the F-Tags from the old SOM accurately state CMS policy regarding the new regulations at the time of the survey is not an issue that the parties have raised in this case.  The new regulations, not the SOM, control the decision in this case.  Furthermore, Petitioner made no objection that it was not adequately informed of the allegation of noncompliance it must defend against.
• 6. CMS and the state agency use scope and severity levels 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, § 7400E.  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.  Scope and severity levels 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 are 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.
• 7. Resident 1's weight was listed as 89.09 kilograms.  The dietician multiplied the resident's weight in kilograms by a fluid factor of 3.0.  The result was 2672 ml of fluid required daily.  Tr. 149, 152.  According to the National Institute of Standards and Technology (NIST) Physical Measurement Laboratory, to convert ml to fluid ounces, one multiplies the amount in milliliters by 0.034, which in this case yields 90.848 fluid ounces.  Accurate conversion factors are found at https://www.nist.gov/pml/weights-and-measures/metric-household.