Navasota Nursing and Rehabilitation LP, DAB CR5974 (2021)

DECISION

Petitioner violated 42 C.F.R. § 483.80(g)(1)-(2).References are to the Code of Federal Regulations (C.F.R.) as revised effective September 2, 2020, unless otherwise indicated.  85 Fed. Reg. 27,627 (May 8, 2020); 85 Fed. Reg. 54,873 (Sept. 2, 2020).  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 version of the C.F.R. in effect at the time a survey was conducted.  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).  In this case, CMS conducted a review on December 7, 2020, and determined that Petitioner failed to report its facility’s COVID-19 information for the week of November 30, 2020 through December 6, 2020.  CMS’s compliance determination and imposition of an enforcement remedy was issued on December 7, 2020.  The specific regulations that Petitioner allegedly violated—42 C.F.R. § 483.80(g)(1)-(2)—were issued as an interim final rule on May 8, 2020.  85 Fed. Reg. 27,550 at 27,601-02, 27,627 (May 8, 2020).;  Additionally, on September 2, 2020, CMS issued an interim final rule establishing a new enforcement regulation at 42 C.F.R. § 488.447, which was “specifically tailored to reviewing compliance with and imposing” civil money penalties in connection with a facility’s failure to report pursuant to 42 C.F.R. § 483.80(g)(1)-(2).  85 Fed. Reg. 54,820 at 54,823-25, 54,873 (Sep. 2, 2020).  However, the violation did not pose the risk for more than minimal harm and there is no noncompliance.  There is, therefore, no basis for the imposition of an enforcement remedy in this case.

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I.  Background

Petitioner is located in Navasota, Texas, and participates in Medicare as a skilled nursing facility (SNF) and the state Medicaid program as a nursing facility (NF).  Joint Stipulation of Undisputed Facts (Jt. Stip.) at 1 ¶¶ 1-2.

The Centers for Medicare & Medicaid Services (CMS) notified Petitioner by letter dated December 7, 2020, that a review of data in the Centers for Disease Control and Prevention’s (CDC) National Healthcare Safety Network (NHSN) system, revealed Petitioner failed to report specific information about its operations related to the COVID-19 pandemic as required by 42 C.F.R. § 483.80(g)(1) and (2).  CMS informed Petitioner that it determined that Petitioner was not in substantial compliance with 42 C.F.R. § 483.80(g).  CMS advised Petitioner that it was imposing a civil money penalty (CMP) of $1,000.00 for one day – December 7, 2020.  CMS further advised Petitioner that “[e]ach subsequent week that the facility fails to [report COVID-19 data as required], the noncompliance will result in an additional one-day CMP imposed at an amount increased by $500 over the previously imposed CMP.”  Jt. Stip. at 1-2 ¶¶ 4-5; CMS Exhibits (Exs.) 1-2.

Petitioner requested a hearing (RFH) before an administrative law judge (ALJ) on February 2, 2021.  The case was assigned to me for hearing and decision and on February 5, 2021, an Acknowledgment Letter and Standing Order were issued at my direction.

On May 4, 2021, CMS filed CMS Exs. 1 through 4.  On June 2, 2021, Petitioner filed Petitioner’s exhibits (P. Exs.) 1 and 2.  On July 2, 2021, the parties filed their Joint Stipulation of Undisputed Facts.  CMS also filed a motion for summary judgment on July 2, 2021.  However, in the parties’ Joint Status Report filed on July 2, 2021, Petitioner waived its right to an oral hearing and requested a decision based on the written record.  CMS agreed in the Joint Status Report that no oral hearing is necessary in this case, rendering the CMS motion for summary judgment moot as this case can be decided on

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the documents without the need for an oral hearing.  On July 2, 2021, I accepted the waiver of oral hearing.  The parties filed briefs (CMS Br. and P. Br., respectively) and reply briefs (CMS Reply and P. Reply, respectively).  Neither party objected to the offered exhibits.  CMS Exs. 1 through 4 and P. Exs. 1 and 2 are admitted as evidence.

II.  Discussion

A.  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 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 and 42 C.F.R. pt. 483.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.

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 after the date the facility is found to be in noncompliance.  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 the facility is found to be in noncompliance – 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 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 other remedies such as 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 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.

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§ 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.  42 C.F.R. §§ 488.400 (enforcement remedies authorized when facility is not in substantial compliance); 488.402(b) (enforcement remedies are applied based on noncompliance); 488.408(g)(1) and 498.3(b)(13) (facility may only request review of a certification of noncompliance for which an enforcement remedy is imposed).

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.  Generally, 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 a CMP, $6,808 to $22,320 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 a CMP, $112 to $6,695 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.  CMS is also authorized to impose a per instance CMP in the range of $2,233 to $22,320.  42 C.F.R. § 488.438(a)(1)(ii), (2); 45 C.F.R. § 102.3 (Table).

In this case, however, the usual process for the imposition of CMPs does not apply.  Effective September 2, 2020, the Secretary promulgated a regulation granting CMS authority to impose CMPs specifically for violation of 42 C.F.R. § 483.80(g)(1) and (2), i.e., to compel compliance with 42 C.F.R. § 483.80(g)(1) and (2).  85 Fed. Reg. 54,820, 54,823-54,825, 54,873 (Sep. 2, 2020).  42 C.F.R. § 483.80(g) was added on May 8, 2020.  85 Fed. Reg. 27,550, 27,601 (May 8, 2020).

Pursuant to 42 C.F.R. § 483.80(g), a nursing home must weekly, electronically report COVID-19 information in a format specified by the Secretary.  42 C.F.R. § 483.80(g)(1).  Reporting is to the CDC’s NHSN and the regulation provides that the information will be reported to the public by CMS.  42 C.F.R. § 483.80(g)(2).  A long-term care facility that fails to comply with the reporting requirements of 42 C.F.R. § 483.80(g)(1) and (2) is subject to the imposition of a CMP.  42 C.F.R. § 488.447.  CMS is authorized to impose a CMP of not less than $1,000 for the first violation.  CMS is authorized to increase the

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CMP by $500 for each subsequent occurrence but not to exceed the amount authorized by 42 C.F.R. § 488.408(d)(1)(iii), i.e. the top of the lower range of authorized CMPs as adjusted annually.  45 C.F.R. pt. 102.  Whether a facility is complying with reporting requirements under 42 C.F.R. § 483.80(g)(1) and (2) is assessed weekly.  Facilities found not in compliance are not required to submit a plan of correction.  Although not specifically stated in the regulation, the preambleEach agency submitting a proposed or final rule for publication in the Federal Register must provide a preamble to inform the reader of the basis and purpose of the regulation or proposal.  1 C.F.R. § 18.12.  In promulgating regulations, the Secretary must publish the proposed regulation in the Federal Register and allow no fewer than 60 days for public comment.  Act § 1871. for the interim final rule that added 42 C.F.R. § 488.447 establishes the presumption that failure to accomplish the required weekly report poses a widespread risk for more than minimal harm that is not immediate jeopardy and without actual harm.  85 Fed. Reg. at 54,823.

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 enforcement remedies or the factors CMS considered when choosing enforcement 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 nurse aide training and competency evaluation program (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).

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).

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The allocation of the burden of persuasion and the quantum of evidence required to meet the burden is not addressed by the regulations.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.  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 (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.”  Evergreene Nursing, DAB No. 2069; Batavia Nursing & Convalescent Ctr., DAB No. 1904.  “Prima facie” means generally

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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 a prima facie showing of noncompliance by a preponderance of the evidence based on the undisputed fact that Petitioner failed to make its report for the week of November 30 through December 6, 2020, and the presumption established by the preamble for 42 C.F.R. § 488.447 that failure to report poses a risk for more than minimal harm for Petitioner’s residents.  85 Fed. Reg. at 54,823.  However, I conclude that Petitioner rebutted the presumption of a risk for more than minimal harm to Petitioner’s residents through sworn testimony.  P. Ex. 1.  Accordingly, I conclude that there is no noncompliance that permits the imposition of the enforcement remedy authorized by 42 C.F.R. § 488.447 for a violation of 42 C.F.R. § 483.80(g)(1) and (2).

B.  Issues

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

Whether the remedy proposed is reasonable.

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, although not all may be specifically discussed in this decision.  I discuss the credible evidence given the greatest weight in my decision-making.“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.  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

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be consistent with notions of judicial economy to do so.  Charles H. Koch, Jr., Admin. L. and Prac. § 5:64 (3d ed. 2013).

1.  Petitioner violated 42 C.F.R. § 483.80(g)(1)-(2) as alleged under Tag F884 (CMS Ex. 2) because it is undisputed that Petitioner failed to file the report required by the regulation.

2.  The presumption that Petitioner’s violation of 42 C.F.R. § 483.80(g)(1)-(2) posed a risk for more than minimal harm to Petitioner’s residents, an element of the CMS prima facie case, is rebutted.

3.  There is no basis for the imposition of an enforcement remedy in this case. 

All long-term care facilities, including Petitioner, are required to electronically report weekly in a standardized format specified information related to COVID-19 through the CDC’s NHSN system.  42 C.F.R. § 483.80(g)(1)-(2).

There is no dispute that Petitioner failed to submit the required report for the week of November 30 through December 6, 2020, through the CDC’s NHSN.  CMS Exs. 1-2; P. Ex. 1 at 2; Petitioner’s Prehearing Brief (P.P.B.) at 8.  Petitioner admits that the requirement for CMS to make a prima facie showing of a regulatory violation is satisfied.  P. Reply at 1.

However, Petitioner argues that CMS has failed to make a prima facie showing that Petitioner’s violation of 42 C.F.R. § 483.80(g)(1) and (2) posed a risk for more than minimal harm.  Alternatively, Petitioner argues that it has rebutted that element of the CMS prima facie case.  P.P.B. at 8-9; P. Br. at 1-2; P. Reply at 1-3.

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 violation42 C.F.R. §§ 488.301, 488.400, 488.402(b), 488.408(g)(1), and 498.3(b)..

The preamble for 42 C.F.R. § 488.477, establishes the presumption that a facility’s violation of 42 C.F.R. § 483.80(g)(1) and (2) poses a risk for more than minimal harm to facility residents.  85 Fed. Reg. at 54,823.  I conclude that CMS is entitled to rely upon the presumption to satisfy the third element of its prima facie case, i.e., that the regulatory violation posed a risk for more than minimal harm to facility residents.  However, the preamble does not provide or suggest that the presumption cannot be rebutted by Petitioner.  Petitioner placed in evidence the declaration of Karen Miller, RN, CLNC, WCC, Vice President of Clinical Services for Daybreak Ventures.  CMS did not object to the declaration and by agreeing to the waiver of oral hearing waived its right to cross-examine RN Miller.  RN Miller testified that she was responsible for overseeing Petitioner during the period November 30 through December 6, 2020.  She testified that she investigated the deficiency alleged by CMS, discussed the matter with Petitioner’s administrator, and reviewed related documents.  She testified that, based on her expertise as an RN, Wound Care Certified Nurse, and a Certified Legal Nurse Consultant, that Petitioner’s failure to file the required report despite its efforts to do so posed no risk for more than minimal harm to any facility resident.  RN Miller’s testimony is unrebutted by any evidence presented by CMS, such as testimony from a surveyor involved in the review based on which the noncompliance was alleged or any other evidence showing the violation posed a risk for more than minimal harm.

I conclude that Petitioner has rebutted the third element of the CMS prima facie case.  Accordingly, I conclude that while 42 C.F.R. § 483.80(g)(1) and (2) were violated by Petitioner, the violation did not pose a risk for more than minimal harm.  I further conclude that there is no noncompliance for which CMS is authorized to impose an enforcement remedy.

Even if I accept as correct the CMS argument that Petitioner requests review of the scope and severity determination of CMS (CMS Br. at 6), that argument does not deprive

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Petitioner of review of whether there was a risk for more than minimal harm.  However, CMS is correct that review of the scope and severity determination is limited.  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 (for SNFs or NFs, the scope of review during a hearing on the imposition of a civil money penalty is set forth in § 488.438(e) of this chapter and for HHAs, the scope of review during a hearing on the imposition of a civil money penalty is set forth in § 488.845(h) of this chapter); 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.  Therefore, there was no noncompliance, i.e., a regulatory violation and a risk for more than minimal harm, and CMS is authorized to impose no CMP rather than a CMP of $1,000.

Pursuant to 42 C.F.R. § 498.60(c)(2), CMS’s determination of the level of noncompliance must be upheld unless it is shown to be clearly erroneous.  Whether the clearly erroneous standard or the lesser preponderance of the evidence standard should be applied to decide if Petitioner has rebutted the CMS prima facie showing that there was a risk for more than minimal harm is an issue to consider.  CMS must show a risk for more than minimal harm as part of its prima facie showing of noncompliance.  Arguably, when as here, that element is rebutted by a preponderance of the credible and weighty evidence, no noncompliance exists, and no level of noncompliance can be declared by CMS.  However, even if one determined that the presumption established by the preamble could not be rebutted by preponderant evidence and imposed on Petitioner the burden to show that the presumption is clearly erroneous, I am satisfied that high burden is met 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).

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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.  Based on my review of the evidence, I have a definite and firm conviction, that the CMS conclusion that the regulatory violation posed a risk for more than minimal harm is erroneous.

Accordingly, I conclude that Petitioner violated 42 C.F.R. § 483.80(g)(1)-(2), 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.

III.  Conclusion

For the foregoing reasons, I conclude that Petitioner violated 42 C.F.R. § 483.80(g)(1)-(2).  However, the violation did not pose a risk for more than minimal harm, there is no noncompliance, and no enforcement remedy is authorized.