Monument Hill Nursing and Rehabilitation Center, DAB CR6750 (2025)

DECISION

The survey in this case was conducted in violation of the requirements of section 1819(g) of the Social Security Act (Act) (42 U.S.C. § 1395i-3(g)).  Because the survey was conducted in violation of the Act, the noncompliance cited by the survey is not a basis for the imposition of any enforcement remedy.

But if on appeal the statutory violation is overlooked or excused, I conclude that Petitioner violated 42 C.F.R. § 483.80(a)(1),1 and the violation posed a risk for more than minimal harm.  If findings of noncompliance are upheld on further review, a per-instance civil money penalty (PICMP) of $15,000 and a denial of payment for new admissions (DPNA) from October 9 through 14, 2021, are reasonable enforcement remedies for the noncompliance based on the violation of 42 C.F.R. § 483.80(a)(1).

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I.     Background

Petitioner is a skilled nursing facility (SNF) participating in Medicare and a nursing facility (NF) participating in Texas Medicaid.  Petitioner is in La Grange, Texas.  Joint Stipulation of Facts and Joint Statement of Issues (Jt. Stip.) at 1-2.

Three surveyors under contract with CertiSurv,2 a private company under contract with the Texas Health and Human Services Commission (state agency), completed a complaint investigation, also referred to as a survey, at Petitioner on September 11, 2021.  Pursuant to its contract with the state, CertiSurv surveyors were assigned to conduct surveys by CertiSurv.  No employees of the state agency were at Petitioner during the investigation of the complaints.  If during the survey the surveyors had questions, they were required to contact higher authority at CertiSurv who then contacted the state agency.  Centers for Medicare & Medicaid Services (CMS) Exhibits (Exs.) 1, 2, 3; Tr. I3 43, 72-74, 120-22, 144, 165-66, 169-79, 182-83, 235-36; Tr. II 3-17.

CMS notified Petitioner by letter dated December 23, 2021, of its initial determination to impose enforcement remedies based on the findings of noncompliance from the survey of Petitioner completed on September 11, 2021.  CMS advised Petitioner that the state agency determined Petitioner returned to substantial compliance with Medicare participation requirements on October 15, 2021.  CMS imposed a PICMP of $15,000 for an alleged violation of 42 C.F.R. § 483.80(a) (Tag F8804 Infection Control).  CMS also

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advised Petitioner that a DPNA was in effect from October 9 through 14, 2021, and that the state agency previously imposed a directed plan of correction.  CMS Ex. 3 at 1-3.

Petitioner filed requests for hearing (RFH) before an administrative law judge (ALJ) on November 11, 2021 and February 18, 2022.  The cases were assigned to me for hearing and decision.  On February 23, 2022, the cases were consolidated.  My Standing Order was issued at my direction.

A hearing was convened by video conference on March 6 and 7, 2023.  A transcript was prepared.  CMS offered CMS Exs. 1 through 57 as evidence and CMS Exs. 1 through 54 were admitted.  Tr. I 24-28.  Petitioner offered Petitioner’s Exhibits (P. Exs.) 1 through 7, which were admitted as evidence.  Tr. I 29; Tr. II 17-20.  CMS called the following witnesses to testify:  CertiSurv Surveyors Heather DeVooght, Miranda Nixon, and Melissa Slaughter.  Petitioner called the following witnesses to testify:  Raymundo (Ray) Vasquez, Petitioner’s administrator, and Tammy Barnett, RN.

On May 23, 2023, after the hearing in this case, Petitioner offered P. Ex. 8.  CMS did not object, and P. Ex. 8 is admitted as evidence.  On June 9, 2023, CMS offered CMS Exs. 58 through 63, which are admitted as evidence in the absence of objection by Petitioner.

The parties filed post-hearing briefs on June 9, 2023 (CMS Br. and P. Br., respectively).  The parties filed post-hearing reply briefs on July 10, 2023 (CMS Reply and P. Reply, respectively).  The parties also filed proposed findings of fact and conclusions of law for my consideration.

II.     Discussion

A.  Applicable Law5

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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 Act6and 42 C.F.R. pt. 483.  Section 1819(h)(2) of the Act authorizes the Secretary to impose enforcement remedies against a SNF for failing 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.

The Act requires the Secretary to 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 noncompliant.  Act § 1819(h)(2)(C).  The Act also requires the Secretary to 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 noncompliant – commonly referred to as the mandatory or statutory DPNA.  Act § 1819(h)(2)(D).  The Act grants the Secretary discretionary authority to terminate noncompliant SNFs’ 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, civil money penalties (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.  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.  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 to be not in substantial

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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 (Act authorized Secretary to impose enforcement remedies when facility is not in substantial compliance), 488.402(b) (enforcement remedies are applied based on noncompliance), 488.408(g)(1), 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 a program participation requirement.  The regulations specify that a per-day CMP imposed against a facility will fall into one of two ranges of penalties.  42 C.F.R. §§ 488.408, 488.438.  The upper range of a CMP, $6,888 to $22,584 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) (2021).  “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.  The lower range of a CMP, $113 to $6,774 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 $2,259 to $22,584.  42 C.F.R. § 488.438(a)(1)(ii), (2); 45 C.F.R. § 102.3 (Table) (2021).

2. Limited Right to Review of a Determination to Impose an Enforcement Remedy

The Act and regulations give long-term care facilities against which CMS has imposed an enforcement remedy the right to a hearing before an ALJ.  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 nurse aide training and competency evaluation program.  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

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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 limited as prescribed by 42 C.F.R. § 488.438(e).

3. 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.7  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

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ALJ), DAB No. 1663 (1998) (after remand), aff’d, Hillman Rehab. Ctr. v. U.S. Dep’t of Health & Hum. Servs., 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 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 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 a 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 must 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 CMS must support its prima facie case by preponderant evidence, or what happens if it has 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, I conclude that CMS made a prima facie showing of a violation of 42 C.F.R. § 483.80(a)(1) that posed a risk for more than minimal harm by a preponderance of the evidence.  CMS Ex. 1 at 76-81.  Petitioner has not rebutted the CMS prima facie showing of noncompliance.

B.  Issues

The issues in this case include the following:

Whether the survey in this case was conducted in violation of section 1819(g) of the Act.

Whether enforcement remedies may be imposed based on the findings and conclusions of a survey conducted in violation of section 1819(g) of the Act.

Whether Petitioner was in substantial compliance with the Medicare participation requirements.

Whether there is a basis for the imposition of an enforcement remedy and, if so, what is the reasonable enforcement remedy.

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C.  Conclusions of Law

My conclusions of law are based on 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.8  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. L. and Prac. § 5:64 (3d ed. 2013).

1. The survey was conducted in violation of section 1819(g) of the Act.
2. CMS has no authority to impose enforcement remedies based on the findings and conclusions of a survey conducted in violation of the Act.

(a)  Facts

It is not disputed that an investigation of multiple complaints was completed at Petitioner on September 11, 2021.  CMS Ex. 1 at 1.

Three surveyors under contract with or employed by CertiSurv, a private company under contract with the state agency, conducted the complaint investigations.  CertiSurv surveyors were assigned to conduct surveys by CertiSurv.  No employees of the state agency were at Petitioner during the investigation of the complaints.  If during the survey the CertiSurv surveyors had questions, they were required to contact higher authority at CertiSurv who then contacted the state agency.  The CertiSurv surveyors concluded Petitioner was not in substantial compliance with Medicare participation requirements and reported their findings and conclusions in the Statement of Deficiencies (SOD).  CMS Ex. 1.  But the surveyors were not involved in the determination to impose enforcement remedies or the determination of which remedies to impose based on the noncompliance they cited.  CMS Exs. 1, 2, 3; Tr. I 43, 72-74, 120-22, 144, 165-66, 169-79, 182-83, 235-36; Tr. II 3-17.

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(b)  Analysis

The complaint investigation in this case was not conducted by the state agency or by CMS, the only two entities specified as authorized by Congress to conduct surveys and complaint investigations under section 1819 of the Act, based on which the Secretary or his delegate is authorized by Congress to impose an enforcement remedy.9  The use of a contractor to conduct a survey or complaint investigation therefore, exceeds the authority granted by Congress and should prevent the Secretary and CMS from imposing any enforcement remedy based on the noncompliance cited by the CertiSurv surveyors in this case.10

It should be self-evident that an ALJ and the Board are bound to follow the provisions of the Act and the Secretary’s regulations and may not invalidate or choose not to comply

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with either a law or regulation on any ground.  Jewish Home of E. Pa., DAB No. 2380 at 9 (2011); 1866ICPayday.com, L.L.C., DAB No. 2289 at 14 (2009); Sentinel Med. Laboratories, Inc., DAB No. 1762 at 9 (2001), aff’d, Teitelbaum v. Health Care Fin. Admin., 32 F. App’x 865 (9th Cir. 2002).  Because I am bound to follow the provisions of the Act and the Secretary’s regulations, I may not uphold the imposition of an enforcement remedy based on a survey conducted in violation of the Act and regulations.  My decision does not find invalid or reflect a refusal to follow the Act or the Secretary’s regulations.  Rather, this decision enforces the provisions of the Act and regulations that limit the authority of the Secretary and CMS.

Congress Delegated Authority to Survey Skilled Nursing Facilities 
to the Secretary and State Agencies

A SNF is an institution or distinct part of an institution that is primarily engaged in providing skilled nursing and related services or rehabilitation services to its residents; that has a transfer agreement with one or more hospitals; and meets the requirements of section 1819(b), (c), and (d) of the Act.11  Congress established detailed and specific requirements related to SNFs.

In section 1819(b), (c), and (d) of the Act, Congress established the Medicare participation requirements for a SNF.

In section 1819(e) of the Act, Congress specified actions required by the states related to SNFs.

In section 1819(f) of the Act, Congress specified actions required of the Secretary related to SNFs.  Congress specified that “[i]t is the duty and responsibility of the Secretary to assure that the requirements” of sections 1819(b), (c), and (d) of the Act are adequate and enforced “to protect the health, safety, welfare, and rights of residents and to promote the effective and efficient use of public moneys.”  Act § 1819(f)(1).

In section 1819(g) of the Act, Congress established the process for survey and certification of SNFs and specified state and federal responsibilities related to survey and certification of SNFs.  Survey and certification are also controlled by section 1864 of

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the Act.  In section 1864 of the Act Congress specified that the Secretary “shall” make an agreement with states12 that are willing and able to have state health services or another appropriate state agency survey for the Secretary to make a determination whether an entity meets Medicare participation requirements as a hospital, skilled nursing facility, home health agency, hospice program, rural health clinic, critical access hospital, comprehensive outpatient rehabilitation facility, laboratory, and other entity seeking to participate or participating in Medicare.13  Act § 1864(a) (42 U.S.C. § 1395aa(a)).  Congress “authorized” the Secretary to enter into agreements with states to conduct surveys on a “selective sample basis” or when the Secretary deems appropriate because of “substantial allegations of the existence of a significant deficiency or deficiencies” that could “adversely affect the health and safety of patients” of entities that have been accredited under section 1865 of the Act.  Act § 1864(c).  Under section 1865 of the Act, Congress authorized the Secretary to rely upon the determination of a national accreditation body that an entity meets Medicare participation requirements.  Act § 1865.  Section 1865 of the Act establishes the only express exception to the Congressional requirement that the Secretary use the states to conduct surveys of entities seeking to participate or participating in Medicare as a provider.

Returning to section 1819(g)(1) of the Act, Congress provided that:

Pursuant to an agreement under section 1864 [of the Act], each State shall be responsible for certifying, in accordance with surveys conducted under paragraph (2), the compliance of skilled nursing facilities (other than facilities of the State) with the requirements of subsections (b), (c), and (d).  The Secretary shall be responsible for certifying, in accordance with surveys conducted under paragraph (2), the compliance of State skilled nursing facilities with the requirements of such subsections.

Section 1819(g)(3) of the Act requires that the Secretary conduct onsite surveys of a sample of the SNFs surveyed by the state under section 1819(g)(2) of the Act.  The Secretary is authorized to take remedial action against a state for inadequate survey performance.  Act § 1819(g)(3)(C).  Section 1819(g)(3)(D) of the Act authorizes the

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Secretary to conduct a survey of any SNF he suspects may not meet the requirements of subsections 1819(b), (c), and (d) of the Act and make independent and binding determinations regarding compliance.

I conclude based on my review of the Act, that aside from the provisions for accreditation by national accrediting organizations, Congress included no provision in the Act that authorized the Secretary or a state agency to use private contractors to conduct surveys to determine compliance or noncompliance with Medicare participation requirements established by the Act and regulations.  The regulations are not inconsistent with the Act and do not purport to grant authority to use private contractors to conduct surveys rather than a state agency or CMS.

Congress required in section 1871 of the Act that the Secretary promulgate regulations necessary to administer Medicare.  Azar v. Allina Health Servs., 587 U.S. 566 (2019).14  The Secretary issued regulations controlling survey and certification in 42 C.F.R. pt. 488. 

In 42 C.F.R. § 488.1, “state survey agency” is defined as “the state health agency or other appropriate state or local agency CMS uses to perform the survey and review function as provided in sections 1864, 1819(g), and 1919(g) of the Act.”  The use of national

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accrediting organizations as authorized by section 1865 of the Act is covered by 42 C.F.R. § 488.4-.9.  The requirement for the Secretary to enter agreements with states (§ 1864 Agreements) to use state or local agencies to conduct surveys to determine Medicare compliance and to validate accreditation by an accrediting organization is recognized by 42 C.F.R. §§ 488.10(a) and (c), and 488.11.  Under 42 C.F.R. § 488.12, the state agency makes a certification of its survey findings to CMS and based on the certification CMS determines whether a provider or supplier is eligible to participate in or be covered by Medicare.  Under 42 C.F.R. §§ 488.20 and 488.24, state agencies conduct the periodic surveys and certifications of compliance or noncompliance.  Specific principles that state agencies must satisfy when conducting surveys are established by 42 C.F.R. § 488.26(c).

Specific regulatory requirements for survey and certification of long-term care facilities, i.e., SNFs under section 1819 of the Act and NFs under section 1919 of the Act, were promulgated by the Secretary in 42 C.F.R. pt. 488 subpt. E.  Under 42 C.F.R. § 488.305(a), the state survey agency “must conduct standard surveys”15 for each SNF and NF.  The frequency of standard surveys is specified by 42 C.F.R. § 488.308.  The state survey agency also conducts other surveys such as abbreviated standard surveys (42 C.F.R. § 488.308(c) and (e)) and extended surveys (42 C.F.R. § 488.310).  The state survey agency also conducts complaint investigations under authority of 42 C.F.R. §§ 488.308(f) and 488.332.  Pursuant to 42 C.F.R. § 488.312, CMS and the state survey agency are required to implement programs to measure accuracy and improve consistency in the survey process and the imposition of enforcement remedies.  The Secretary adopted sanctions that may be imposed on a state survey agency for inadequate survey performance.  42 C.F.R. § 488.320.

The Secretary provided in 42 C.F.R. § 488.330(a)(1)(i), that state survey agencies “survey all facilities for compliance or noncompliance with requirements for long term care facilities.”  42 C.F.R. § 488.330(a)(1)(i).  A federal validation survey may follow a state agency survey.  Certification of compliance or noncompliance is based on state survey agency findings or CMS survey findings for state-operated facilities.  42 C.F.R. § 488.330(a)(2).  A certification of noncompliance requires enforcement action.  42 C.F.R. § 488.330(b)(2).

Aside from the provisions for accreditation by national accrediting organizations, the regulations do not state that the Secretary, CMS, or the state, are authorized to use private

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contractors to conduct surveys or investigations to determine compliance or noncompliance.

The foregoing review of provisions of the Act and the Secretary’s regulations shows that the Secretary was empowered by Congress to administer Medicare.  But the Secretary was not delegated unlimited power to do so.  Rather, Congress imposed very specific obligations and requirements upon the Secretary as part of the limited delegation of authority.  The limitations and obligations, i.e., the limitations on delegation, are specified in the Act, and the Secretary’s delegation to CMS by regulation reflects the same statutory limitations.  Based on findings of surveys conducted by CMS or a state survey agency, the Secretary is required by Congress to impose enforcement remedies upon a SNF or NF that is not in compliance with Medicare participation requirements based on the recommendation of a state survey agency.  Act § 1819(h)(2).  States have the authority to impose enforcement remedies pursuant to section 1919 of the Act.  The Secretary has delegated his authority to impose enforcement remedies to CMS.  42 C.F.R. pt. 488, subpt. F.  No provisions of the Act or regulations authorize the imposition of enforcement remedies based on the recommendation of a private contractor, not even a national accrediting body.16

Government contracting by executive branch agencies is subject to the Federal Acquisition Regulations.  48 C.F.R. § 1.101 (FAR § 1.101).  The FAR is instructive in this situation to illustrate the error of using the private contractor CertiSurv and its employees or subcontractors to conduct a survey of a long-term care facility, which is an

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inherently governmental function.17  FAR § 7.503(a) (48 C.F.R. § 7.503(a)) prohibits the use of a contract for the performance of inherently governmental functions.  A lengthy list of examples of functions considered to be inherently governmental is set forth in FAR § 7.503(c).  FAR § 7.503(c)(15) lists the approval of federal licensing actions and inspections as an example of an inherently governmental function.  It may be argued that enrollment in Medicare and entering a provider agreement with the Secretary is not a license and surveys are not inspections.  However, the Act and regulations are clear that an entity must enroll in Medicare subject to approval of the Secretary and, based on that enrollment, the entity is permitted to participate in Medicare subject to surveys to determine compliance.  The similarity to licensing and inspections is readily apparent, at least to the extent it is possible to recognize the existence of an inherently governmental function for which no executive branch agency should award a contract.  FAR § 7.503(c)(17) lists as an example of an inherently governmental function the disbursement of public funds.  FAR § 7.503(c)(18) lists control of treasury accounts as an example of an inherently governmental function.  FAR § 7.503(c)(19) lists the administration of public trusts as an example of inherently governmental functions.  Title XVIII of the Act grants the Secretary authority to control access to the Medicare trust funds,18 which is accomplished in part by the survey and certification of skilled nursing facilities – further illustrating that survey and certification should be considered an inherently governmental function.

I conclude that the state agency and CMS use of a contractor to conduct a complaint investigation survey under section 1819(g) of the Act exceeded the Congressional delegation of authority to the Secretary under the statute.

Congress Delegated Authority to the Secretary to Impose Enforcement Remedies such as a CMP for Surveys Conducted Under Section 1819(g) of the Act.

No Enforcement Remedy May be Imposed or Approved for a Survey not Conducted in Accordance with Section 1819(g) of the Act.

Congress authorized the Secretary to take actions against a SNF that is not in compliance with Medicare participation requirements of section 1819(b), (c), and (d) of the Act.  The actions, often referred to as enforcement remedies, are describe in section 1819(h)(2)(B) of the Act.  Section 1819(h)(5) of the Act provides that the remedies authorized by

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section 1819(h) are in addition to those otherwise available under state or federal law and should not be considered to limit other remedies, including any available to an individual under the common law.

Subsection 1819(h)(1) of the Act specifies actions that may be taken by a state if the state finds based on a standard, extended, or partial extended survey conducted pursuant to section 1819(g)(2) or otherwise, that a long-term care facility does not meet Medicare participation requirements to the degree the noncompliance jeopardizes or could jeopardize resident health or safety.  Subsection 1819(h)(2)(A) of the Act authorizes the Secretary to impose enforcement remedies based on the recommendation of the state under subsection 1819(h)(1).  Subsection 1819(h)(2)(A) provides that nothing in that subparagraph may be construed to restrict remedies available to the Secretary to remedy a long-term care facility’s noncompliance.  But while not limiting the remedies available, the plain language of subsection 1819(h) of the Act clearly limits the Secretary’s authority to impose remedies for noncompliance to instances when the noncompliance was found based on the survey process established by subsection 1819(g) of the Act.

I conclude, based on the plain language of section 1819 of the Act, that the Secretary’s authority to impose the enforcement remedies authorized by Congress under section 1819(h) of the Act is contingent upon the Secretary’s or CMS’s compliance with the requirements of section 1819 of the Act, including the survey requirements of section 1819(g).

Parties’ Responses

As I requested at hearing (Tr. I 175-79), both parties addressed the issue in post-hearing briefs.

CMS does not deny the fact that CertiSurv surveyors conducted the survey of Petitioner that ended September 11, 2021.  CMS does not deny that CertiSurv surveyors were not employees of the state agency.  CMS states that CertiSurv had a contract with the state agency.  CMS asserts and there is no dispute that the CertiSurv surveyors had the training required for surveyors by 42 C.F.R. § 488.314(c).  CMS Br. at 2.

In its analysis, CMS focused on the § 1864 Agreement between the Secretary and the State of Texas.  CMS’s position is that the Secretary authorized the Texas state agency to subcontract survey agency activities.  CMS Br. at 6.  But whether the § 1864 Agreement purported to authorize the state agency to subcontract its survey responsibilities to private parties is not the issue.  Rather, the issue is whether the Secretary has authority under the Act to use or authorize the use of private parties to conduct surveys that are then the basis for the imposition of enforcement remedies.

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CMS also cites the Board’s decision in Avon Nursing Home, DAB No. 2830 (2017), arguing that who conducted the survey or how it was conducted are not issues before an ALJ and are simply irrelevant.  CMS argues based on Avon, that I am limited to determining based on the evidence before me whether CMS’s independent finding of noncompliance is supported by the evidence of record.  The CMS position is that an ALJ does not have authority to review whether the Secretary or CMS acted in compliance with the Act and regulations in conducting surveys or imposing enforcement remedies.  The CMS position is that it does not matter whether a survey was conducted and enforcement remedies were imposed as authorized by the Act and regulations and consistent with their requirements.  According to CMS, all that matters is whether the evidence received by the ALJ supports the CMS conclusion that there was noncompliance that can be the basis for the imposition of an enforcement remedy.  CMS Br. at 6; CMS Reply at 1-2.

In Avon, a skilled nursing facility was found not in substantial compliance with Medicare participation requirements by a survey conducted by a state agency.  Avon requested a hearing.  The ALJ concluded that the survey was invalid because the survey team did not include a registered nurse in violation of section 1819(g)(2)(E)(i) of the Act and there was no lawful basis for imposing an enforcement remedy.  The Board concluded that the state agency’s failure to comply with section 1819(g)(2)(E)(i) of the Act did not invalidate the CMS determination that Avon was noncompliant or the enforcement remedy.  Avon, DAB No. 2830 at 1-2.  The Board acknowledged that surveys are to be conducted by state survey agencies under agreements with the Secretary, and that a registered nurse must be included in surveys covered by section 1819(g)(2) of the Act and 42 C.F.R. § 488.314(a)(1).  Avon, DAB No. 2830 at 3.  Factually, the Board found that the state agency performed a complaint survey that found noncompliance that was followed by a compliance survey.  Avon, DAB No. 2830 at 4.  Based on the clarification of the CMS regulations in its August 7, 2017 rulemaking, it is now clear that the surveys of Avon were subject to section 1819(g)(4) of the Act and 42 C.F.R. § 488.332 under which there is no requirement for a registered nurse to participate in a complaint or compliance survey.  82 Fed. Reg. 36,530, 36,624 (Aug. 4, 2017).19  The Board concluded

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it did not need to decide whether a registered nurse was required on the Avon survey team by the Act or regulations.  Avon, DAB No. 2830 at 10.  Rather the Board’s decision upholding the CMS enforcement action is based on the Board’s conclusion that inadequate survey performance is not grounds to overturn CMS findings of noncompliance and the imposition of enforcement remedies based on the noncompliance.  The Board effectively made irrelevant whether the Secretary, CMS, and the state agencies comply with the Act and regulations that authorize surveys and the imposition of enforcement remedies for noncompliance.  According to the Board, even if a survey is conducted in violation of the law, if CMS nevertheless concludes there is noncompliance, the ALJ must conduct a de novo review of the evidence to determine whether there was noncompliance.  Avon, DAB No. 2830 at 9-15.  The Board vacated the ALJ decision in Avon and remanded for further action by the ALJ.  However, there is no further reported history on the case indicating it was resolved by the parties without further action by the ALJ or the Board.  I do not find the Board’s decision in Avon to be persuasive precedent.  It is not a reasonable interpretation of the law to conclude that the Secretary and CMS who act only with authority to administer the Medicare program delegated by Congress can simply ignore the limitations of the delegated authority.  It is also unreasonable to suggest that an ALJ or the Board can simply ignore the law, regulations, and the limitations imposed by Congress.

The CMS argument that the ALJ must determine based on the evidence of record whether there was noncompliance is correct.  But the CMS argument that the ALJ has no authority to review whether the survey and imposition of enforcement remedies complied with the Act and regulations reflects a serious misconception about one of the purposes of granting a regulated entity a right to a neutral adjudicator’s review of agency action.  If the CMS position is to be accepted, CMS could act with impunity as all actions of CMS would have to be upheld without consideration of whether the Secretary and CMS had authority to act and acted in accordance with the authority delegated by Congress.  Clearly this could not be the intent of Congress.  The CMS position is unreasonable and unsupportable.  ALJs and the Board act with delegated authority of the Secretary to review cases for which the Secretary has provided regulated entities a right to a hearing on the record.  As already discussed, ALJs are required to comply with the Act and regulations in providing review to a regulated entity.  If, as CMS suggests, an ALJ or the Board is prevented from reviewing whether CMS acted lawfully, i.e., consistent with the Act and regulations, in conducting a survey and imposing an enforcement remedy, the effect is to preclude the Secretary from correcting an error of law or violation of policy committed by CMS in executing the Act and regulations.  If the CMS position is accepted, then the first review of whether CMS acted lawfully would be by the federal

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court with jurisdiction and not the Secretary.  Congress entrusted the Secretary with responsibility and authority to administer the insurance programs established by the Act, not CMS.  Act § 1871.  The CMS position that ALJs and the Board, who act with delegated authority of the Secretary, have no authority to review the lawfulness of the conduct of surveys by CMS or the state is at odds with the responsibility and authority granted to the Secretary by Congress.

Petitioner provided a detailed analysis of the Secretary’s authority to contract with states to perform surveys under section 1864 of the Act (42 U.S.C. § 1395aa).  Petitioner concluded that the language of section 1864 does not authorize the Secretary, CMS, or the state agency to contract with a private entity to perform the survey function.  Petitioner points out in its analysis that Congress specifically allowed the Secretary to use private accreditation agencies to survey but did not provide for any other type of private entity to exercise authority Congress specifically granted to the Secretary with limited authority to delegate only to CMS or the state agency.  P. Br. 15-21.  Petitioner’s analysis is persuasive.

Petitioner also discusses whether the Secretary’s § 1864 Agreement with Texas authorized the Texas state agency to subcontract its survey responsibility to CertiSurv.  Petitioner begins its analysis commenting that the Act and regulations do not specifically address whether CMS and the state agency can subcontract the survey function to a private entity.  Petitioner suggests that absent a specific authority CMS’s interpretation that it has authority to subcontract should be given preference.  P. Br. at 21-22.  This view suggests that anything not specifically prohibited by Congress is specifically authorized if the Secretary or CMS say so.20  But in sections 1819 and 1864 of the Act, Congress specifically provided for the use of certain accreditation organizations for surveying in addition to surveys performed by CMS or the state but did not provide for surveying by other private entities.  An argument that Congress was silent on whether other private entities could be used to survey is ambiguous and permits statutory interpretation by the Secretary, may be rejected based on the rule of statutory construction expressio unius est exclusio alterius, i.e., “the express mention of some things of a class shows that items of the class not mentioned are excluded.”  Black’s Law Dictionary at 620-21 (8th ed. 2004).  The language of sections 1819 and 1864 is not ambiguous and does not require the Secretary or CMS to rely upon some implicit delegation of authority to engage in legislative interpretation that adds to the Congressional delegations of authority in sections 1819 and 1864.  As the Supreme Court commented in Loper Bright:

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The very point of the traditional tools of statutory construction is to resolve statutory ambiguities.  That is no less true when the ambiguity is about the scope of an agency’s own power—perhaps the occasion on which abdication [by the courts] in favor of the agency is least appropriate.

Loper Bright Enters. v. Raimondo, 603 U.S. 369, 373 (2024).  I do not accept Petitioner’s concession that the Secretary may simply choose to add to the Congressional delegation of authority, by interpreting the absence of a prohibition as a grant of authority to use private entities, in addition to the expressly permitted use of accreditation organizations to conduct surveys.21

Petitioner considers whether the SOM and the Secretary’s § 1864 Agreement with the Texas state agency provide any authority for the use of private entities.  P. Br. at 22-24; P. Reply at 2-3.  The SOM sets forth CMS policies or CMS interpretive rules.  The § 1864 Agreement is a contract between the state agency and the Secretary.  The issue is whether the Secretary has authority to use or authorize the use of a private entity other than an accreditation organization to perform surveys.  Without such authority, the Secretary has no authority to delegate to CMS through the SOM or to the state agency through the § 1864 Agreement.

Regarding the CMS arguments under Avon, Petitioner argues that the Board’s willingness to ignore inadequate survey performance if recognized at all, should only apply to legitimate determinations of the state agency.  P. Br. at 25; P. Reply at 2-4.  This is a sensible argument to the extent one accepts that violations of the Act or regulations in the performance of surveys should not be acceptable while defects in the performance of the survey may be overlooked if the evidence of record otherwise shows noncompliance occurred.  The facts that the Secretary, the Board, and ALJs are all required to comply with the law established by Congress, and they are jointly obliged to ensure the law is upheld, means none can ignore conduct that violates the law or permit the agency to continue to act contrary to the law including acting without delegated authority.

I conclude that the complaint investigations conducted in this case violated the limitations imposed on the Secretary in section 1819(g) of the Act and those investigations may not

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be bases for the imposition of enforcement remedies.  Accordingly, no enforcement remedy may be imposed or approved based on the noncompliance cited by the survey completed on September 11, 2021.

3. If on further appeal it is determined that the statutory and regulatory violations due to use of private surveyors should be overlooked or excused, I conclude CMS made a prima facie showing of a violation of 42 C.F.R. § 483.80(a)(1) (Tag F880).
4. Petitioner has not rebutted CMS’s prima facie showing of noncompliance under 42 C.F.R. § 483.80(a)(1) (Tag F880), i.e., a violation of the regulation that posed a risk for more than minimal harm.
5. Petitioner’s violation of 42 C.F.R. § 483.80(a)(1), which posed a risk for more than minimal harm, is a basis for the imposition of an enforcement remedy.

a.  Facts

CMS imposed a $15,000 PICMP for an alleged violation of 42 C.F.R. § 483.80, Tag F880, that posed a risk for more than minimal harm without actual harm or immediate jeopardy.  CMS Ex. 3 at 1.

In the SOD for the survey completed September 11, 2021, the surveyors cited violation of 42 C.F.R. § 483.80(a)(1), (2), and (4), (e), and (f).  CMS Ex. 1 at 76.22  The surveyors allege that the deficiency occurred because Petitioner “failed to implement a respiratory protection program compliant with OSHA [Occupational Safety and Health Administration] respirator protection standards, which included medical evaluations, training, and fit testing for the use of N95 respirators.”  CMS Ex. 1 at 78.

The evidence includes guidance from the Centers for Disease Control and Prevention (CDC) (CMS Ex. 7) and the Texas state agency (CMS Ex. 6), and part of the regulations

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issued by OSHA (P. Ex. 7), all of which are relevant to help identify the legal standards applicable to infection control as well as any “national standards” with which Petitioner was bound to comply by 42 C.F.R. § 483.80(a)(1).23

The surveyors cited a CDC policy titled “Proper N95 Respirator Use for Respiratory Protection Preparedness” and last updated August 14, 2020.  The surveyors allege that the CDC policy required that Petitioner comply with OSHA requirements that “healthcare workers who are expected to perform patient activities with those suspected or confirmed to be infected with COVID-19 . . . wear respiratory protection, such as an N95 respirator.”  CMS Ex. 1 at 79.  The surveyors further allege that the CDC policy required that staff who “are required to use respiratory protection must undergo fit testing, medical clearance, and training, which are all required elements of a healthcare facility’s written respiratory protection program.”  CMS Ex. 1 at 79.  The plain language of the CDC document reflects the contents are recommendations or guidance and not requirements.

The CDC document is in evidence as CMS Ex. 7.  The document was not promulgated as a regulation.  The document lists two authors, does not represent it is a policy statement of the CDC, was posted to the CDC blog, and appears to be an information paper for healthcare facilities.  CMS Ex. 7 at 1.  The document encourages facilities to ensure that staff are prepared to use respiratory protection, specifically N95 respirators.  The document states that healthcare workers who may need to care for patients infected or suspected to be infected with COVID-19, should be fit-tested, medically evaluated, and trained for use of the N95 respirator.  CMS Ex. 7 at 1.  The authors state that OSHA requires that healthcare workers caring for patients with suspected or confirmed COVID-19 use a respirator such as an N95; with medical clearance; training; and fit testing.  The authors cite 29 C.F.R. § 1910.134 as the source of the OSHA requirement.  CMS Ex. 7 at 2.  The authors state that if there is limited availability of respirators or fit test kits, employers should continue to try to ensure employees have the right respirator by fit testing.  But they state that under serious outbreak conditions (which is not explained) in which respirator supplies are severely limited, it is okay to use a respirator without fit testing because a respirator provides better protection for the employee than a facemask.  The authors note that a healthcare professional should be able to identify a good fit and obtain a good seal if they perform a user seal check prior to each use of the respirator.  CMS Ex. 7 at 2-3.

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The surveyors allege that Petitioner had a facility policy entitled “COVID-19 Response for Nursing Facilities” dated July 20, 2021.  CMS Ex. 1 at 78-79.  A document placed in evidence as CMS Ex. 6 with the same title and date is not Petitioner’s policy but a document issued by the state agency.  Tr. I 228; Tr. II 34-36, 39-40, 44.  The abstract states that it “provides guidance to Nursing Facilities on Response Actions in the event of a COVID-19 exposure.”  CMS Ex. 6 at 1 (emphasis added).  The surveyors alleged that the document required that Petitioner have a respiratory protection program that complies with OSHA requirements, including medical evaluations, training, and fit testing.  CMS Ex. 1 at 79.  Because the document is characterized by the state agency as providing guidance, I find that the assertion that the document “required” action by Petitioner, is inaccurate and misleading.

The state agency policy provides:

Staff who are have been (sic) appropriately trained and fit-tested can use N95 respirators.[24]  Staff who are caring for residents with COVID-19 or caring for residents in a building with widespread COVID-19 infection, should wear an N95 respirator and all CDC suggested PPE [personal protective equipment].

CMS Ex. 6 at 18.  This passage when given its plain meaning states that staff caring for COVID-19 infected residents or in a facility where there is widespread COVID-19 infection should wear an N95 respirator, but they must be trained and fit-tested.  The passage does not suggest exceptions for fully vaccinated staff, or situations when no N95 respirators are available or if fit testing is not available.  The policy recommends that N95 respirators be made available with other PPE where resident care is provided, if N95 respirators are available and the facility has a respiratory protection program and staff are trained, medially cleared and fit-tested.  CMS Ex. 6 at 34.  According to the state policy, N95 respirators are to be worn when entering an infected resident’s room if the respirators are available and staff are fit-tested.  CMS Ex. 6 at 38.  If there is an outbreak of COVID-19, the policy provides that a nursing facility should “[c]onsider having [health care workers] wear all recommended PPE for care of all residents . . . . [including] an N95 or higher-level respirator.”  CMS Ex. 6 at 38.  The policy provides that health care workers who enter the room of an infected resident must wear an N95 if available but only if the staff are fit-tested.  CMS Ex. 6 at 38.  Regarding PPE, the policy states:

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“[i]f the NF does not have a supply of N95 respirators, facemasks should be worn for droplet protection.  Follow CDC’s Interim Infection Prevention and Control Recommendations for Residents with Suspected or Confirmed COVID-19 in Healthcare Settings . . . .”  CMS Ex. 6 at 44.  This passage does not recommend that staff who are not fit-tested use facemasks rather than N95s.  But based on other passages in the policy already mentioned that may be inferred.  In the event of a COVID-19 outbreak, that is, one or more laboratory confirmed cases of COVID-19, a facility was encouraged to “[c]onsider having [healthcare workers] wear all recommended PPE for COVID-19 (gown, gloves, eye protection, N95 respirator) for the care of all residents [on the affected unit], regardless of presence of symptoms.”  CMS Ex. 6 at 55.  The policy recommended that a facility consider designating an entire unit in the facility for known or probable COVID-19 cases with staff appropriately trained and fit-tested for N95 respirators.  CMS Ex. 6 at 55.  The state policy states staff should wear an N95 and all suggested PPE according to CDC guidance, when caring for residents with COVID-19 or when COVID-19 is widespread in the facility.  The state policy provides the following:

N95 respirator fit testing – Under serious outbreak conditions in which respirator supplies are severely limited, [healthcare workers] may not have the opportunity to be fit-tested on a respirator before using it.  NFs should make every effort to ensure [healthcare workers] who need to use tight-fitting respirators are fit-tested to identify the right respirator for the [healthcare worker].  Under serious outbreak conditions, there may be limited availability of respirators or fit-test kits.

If NFs cannot fit-test [healthcare workers] for N95 respirators, they should follow the NIOSH [(National Institute for Occupational Safety and Health)25] guidance for respirator use in a serous outbreak.

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While it is not ideal, even without fit-testing, a respirator will provide better protection than a facemask or using no respirator at all.  NFs should assist the [healthcare worker] in choosing a respirator that fits best.

Even if [healthcare workers] begin using respirators without proper fit-testing, NFs should make every effort to perform fit-testing as respirator supplies allow.  NFs should always perform fit-testing for workers who cannot successfully seal check their own respirators.

CMS Ex. 6 at 56-57.  This passage clearly shows that Texas does not prohibit the use of an N95 respirator by staff even if fit-testing has not been performed or require fit-testing before the use of an N95.  The state agency certainly encourages fit testing of respirators before use.  When necessary to use a respirator without fit testing, the state agency indicates it is acceptable to rely on the user seal check performed each time a wearer puts on the respirator to ensure that the respirator provides a good seal.  There is a positive pressure check and a negative pressure check, both involve covering the respirator filter with the hands and either blowing out or trying to breath in.  CMS Ex. 6 at 57, 86-87.

The surveyors allege that Petitioner violated 26 Tex. Admin. Code § 554.1601(a).  CMS Ex. 1 at 81.  The Texas Administrative Code requirement is:

(a) General.  The facility must establish and maintain an infection prevention and control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable diseases and infections.

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26 Tex. Admin. Code § 554.1601(a) (2021).  But the Texas Administrative Code does not require use of an N95 or require fit testing for healthcare workers.

(e) Vaccinations.

(1) A facility must develop and implement a written policy to protect a resident from vaccine preventable diseases in accordance with Texas Health and Safety Code, Chapter 224.

(A) The policy must:

* * * *

(v) for an employee, contractor, or other individual with privileges to provide direct resident care who is exempt from the required vaccines, include procedures the employee, contractor, or other individual must follow to protect residents from exposure to vaccine preventable diseases, such as the use of protective equipment, such as gloves and masks, based on the level of risk the employee, contractor, or other individual presents to residents by the employee’s, contractor’s, or other individual’s routine and direct exposure to residents[.]

26 Tex. Admin. Code § 554.1601(e)(1)(A).  Tex. Health & Safety Code chap. 224 (2011) also does not require the use of N95 respirators.

Pursuant to 26 Tex. Admin. Code § 554.1602 (1995), universal precautions must be used by Petitioner for care of all residents.  Furthermore, the Texas code requires Petitioner to comply with bloodborne pathogen requirements established by OSHA.

The federal regulation Petitioner allegedly violated requires that Petitioner establish an infection prevention and control program (IPCP) with specified elements including:

(1) A system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing services under a contractual arrangement based upon the facility assessment conducted

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according to § 483.71 and following accepted national standards.

42 C.F.R. § 483.80(a)(1) (emphasis added).  The regulation does not define national standards or identify sources for national standards.  The regulations require that Petitioner have written standards, policies, and procedures that require, among other things, following standard and transmission-based precautions to prevent the spread of infection.  42 C.F.R. § 483.80(a)(2)(iii).  The regulation does not define or identify a source for “standard and transmission-based precautions.”  The regulations in 42 C.F.R. pt. 483, which establish participation requirements for long-term care facilities, do not mention the use of masks or respirators such as the N95.

The foregoing discussion shows that the CDC issued guidance to long-term care facilities regarding the use of N95 respirators.  But the guidance was not enforceable as a law because it was not issued as a regulation or statute.  See Azar v. Allina Health Servs., 588 U.S. 566.  The Texas guidance in evidence also does not appear on its face to impose an enforceable legal standard, but the record is not clear on that.  The CDC and Texas guidance gave facilities significant discretion related to the use of N95 respirators.  Both the CDC and Texas guidance are evidence of national standards as referred to in 42 C.F.R. § 483.80(a)(1).  The national standard recognized many exceptions related to the use of N95 respirators, which were arguably detrimental to the effective use of respirators.  Moreover, the national standard is not controlling because at the time of the survey there were OSHA regulations in effect with which Petitioner was bound to comply.

OSHA in announcing its COVID-19 Emergency Temporary Standard (ETS) discussed in considerable detail problems with existing inconsistent guidance to healthcare facilities from the CDC and the states.  On June 21, 2021, OSHA published an interim final rule establishing its COVID-19 ETS.  The purpose stated was to protect healthcare and healthcare support service workers from occupational exposure to COVID-19 in settings where people with COVID-19 are reasonably expected to be present.  The ETS provided it was effective immediately.  Compliance dates listed were July 6 and 21, 2021, for the various provisions of the ETS, more than a month prior to the survey in this case.  The ETS also requested comments about any of its provisions and whether it should become a final rule.  86 Fed. Reg. 32,376 (June 21, 2021).26  The ETS was issued because OSHA

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determined that SARS-CoV-2, the virus that causes COVID-19, presented a grave danger to workers, particularly healthcare and healthcare support workers, despite the growing use of vaccines, and immediate action was required to protect employees from the danger.  86 Fed. Reg. at 32,376-80, 32,400-11.  OSHA states in the ETS:

Based on its thorough review of OSHA’s existing approach to protecting employees from COVID–19, OSHA finds that existing OSHA standards, the General Duty Clause, and nonmandatory guidance issued by OSHA are not adequate to protect healthcare employees from COVID–19.  Similarly, the numerous guidance products published by other entities, such as CDC, are not sufficiently effective at protecting these employees because such guidance is not enforceable and there is no penalty for noncompliance.  OSHA has determined that each of these tools, as well any combination of them, is inadequate to address COVID-related hazards in the settings covered by this standard, thereby establishing the need for this ETS.

This inadequacy has also been reflected in the number of states and localities that have issued their own mandatory standards in recognition that existing measures (including nonmandatory guidance, compliance assistance, and enforcement of existing standards) have failed to adequately protect workers from COVID–19.  While these state and local requirements may have had positive effects where they have been implemented, they are no replacement for a national standard that would establish definitively that COVID–19 safety measures are no longer voluntary for the workers covered by this standard.  Without a national standard, the patchwork of inconsistent requirements has proven both ineffective at a national level and burdensome to employers operating across jurisdictions, increasing compliance costs

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and potentially limiting the ability to implement protective measures at scale (See ORCHSE, October 9, 2020).  Congress has charged OSHA with protecting America’s workforce, and an ETS is the only measure capable of providing adequate protection to the workers covered by this standard from the grave danger posed by COVID–19.

86 Fed. Reg. at 32,415-16.  OSHA discussed the inadequacy of existing regulations and guidance from federal agencies and the myriads of state and local regulations.  86 Fed. Reg. at 32,413, 32,416.  OSHA noted that:

[M]ost of the safety measures known to reduce the hazard of COVID-19 transmission are not explicitly required by existing standards:  none expressly requires measures such as facilitating vaccination, facemasks, physical distancing, physical barriers, cleaning and disinfection (when appropriate), improved ventilation to reduce virus transmission, isolation of sick employees, minimizing exposures in the highest hazard settings such as aerosol-generating procedures on patients with suspected or confirmed COVID-19, patient screening and management, notification to employees potentially exposed to people with COVID-19, or training on these requirements.

86 Fed. Reg. at 32,416.  OSHA recognized that existing standards did not address some of the most important COVID-19 mitigation measures; existing standards did not specifically address COVID-19 making it difficult for employers to determine what safety measures are required for COVID-19; some existing standards had no application to COVID-19 hazards for employees; and record keeping required by existing standards was inadequate for COVID-19 workplace exposures.  OSHA specifically noted that existing standards did not address facemasks for a hazard such as COVID-19 either as source control (protecting others) or protection of the wearer.  Therefore, OSHA decided to adopt an ETS with a national scope to specifically address COVID-19.  86 Fed. Reg. at 32,417.  OSHA noted that the ETS would allow OSHA to impose more meaningful penalties for violation of the national standards it adopted in the ETS.  86 Fed. Reg. at 32,418-20.  OSHA recognized that there was considerable confusion related to shortages of respirator and fit testing supplies and various guidance from the federal agencies regarding conservation.

OSHA is therefore clarifying that respirators are required for the protection of workers exposed to suspected or confirmed sources of COVID–19 in healthcare settings, and in all of those cases the respirators must be used in accordance with

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the Respiratory Protection standard (29 CFR 1910.134).  OSHA also encourages employers, where possible, to select elastomeric respirators or PAPRs instead of filtering facepiece respirators to prevent shortages and supply chain disruption.  Because the crisis capacity strategy is less protective, the employer should only use crisis capacity strategies for a limited period of time and take immediate steps to purchase and use elastomeric respirators or PAPRs in order to prevent future shortages and further expose their workers to the grave danger of COVID–19.

86 Fed. Reg. at 32,438.  Long-term care facilities are covered by the ETS.  86 Fed. Reg. at 32,462; 29 C.F.R. § 1910.502(a)(1) (2022).27  OSHA concluded that compliance with the requirements of the ETS is technologically and economically feasible for typical operations.  86 Fed. Reg. at 32,481, 32,483-554.

OSHA imposed regulatory requirements related to COVID-19 in a healthcare setting effective July 21, 2021, before the survey in this case.  Pertinent provisions are described here.  An employer must develop and implement a COVID-19 plan with site specific information.  29 C.F.R. § 1910.502(c)(1).  The plan must be written unless the employer has 10 or fewer employees.  29 C.F.R. § 1910.502(c)(2).  There is no dispute Petitioner had more than 10 employees.  To be exempt from providing controls, including PPE, in a well-defined environment based on an employee being fully vaccinated, the COVID-19 plan must include policies and procedures for determining employees’ vaccination status.  29 C.F.R. § 1910.502(c)(4)(ii).  A well-defined area is one in which there is no reasonable expectation that anyone with suspected or known COVID-19 will be present.  29 C.F.R. § 1910.502(a)(4).  OSHA regulations do not create an exception for the respirator requirement on the basis that an employee is fully vaccinated except for when the fully-vaccinated employee is in a well-defined area in which there is no reasonable expectation that anyone with suspected or known COVID-19 will be present.  Id.  OHSA requires that an employer provide facemasks to employees and ensure that they are correctly worn.  29 C.F.R. § 1910.502(f)(1).  When an employee has exposure to a person with suspected or confirmed COVID-19, including during an aerosol-generating procedure, the employer must provide a respirator that is used in accordance with 29 C.F.R. § 1910.134.  29 C.F.R. § 1910.502(f)(2), (3).  OSHA defines a respirator as a type of PPE that is certified by NIOSH or the Food and Drug Administration under an emergency use authorization.  Respirators include filtering face piece respirators (a negative pressure particulate respirator with a non-replaceable filter as a part or the entire face piece is made of filter material) like an N95; elastomeric respirators (facepiece is

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made of synthetic or rubber material that can be cleaned and disinfected and is equipped with a replaceable cartridge, canister, or filter); and PAPRs (powered air-purifying respirator).  29 C.F.R. § 1910.502(b).  OSHA requires that employers provide a respirator with other PPE in accordance with the standard and transmission-based precautions described by the CDC in its “2007 Guidelines for Isolation Precautions:  Preventing Transmission of Infectious Agents in Healthcare Settings,” updated July 2019.  29 C.F.R. §§ 1910.502(f)(5), 1910.509(b)(3) (incorporation by reference approved by Director of Federal Register).  Pursuant to 29 C.F.R. § 1910.134(e), an employer must ensure an employee is medically evaluated before using a respirator.  Pursuant to 29 C.F.R. § 1910.134(f), an employer must ensure that fit testing is performed, initially and annually, before an employee may use a negative or positive pressure tight-fitting facepiece using the same make, model, style, and size of the respirator the employee will use.  OSHA recognized no exceptions to the requirement for medical evaluation and fit testing.  OSHA adopted a mini respiratory protection program under 29 C.F.R. § 1910.504, that mentions using a respirator that has not been fit-tested.  But that program only applies in circumstances described in 29 C.F.R. § 1910.502(f)(4), that is, when respirator use is not required but the employer provides a respirator rather than a facemask.

Surveyor Melissa Slaughter, the CertiSurv surveyor who made the findings and conclusion in the SOD under Tag F880, testified that she understood that Petitioner’s policy was to follow OSHA requirements regarding fit testing for N95 respirators.  Tr. I 226, 232.  She identified P. Ex. 4 as Petitioner’s policy that stated that Petitioner followed OSHA’s COVID-19 ETS.  Tr. I 229; P. Ex. 4.  She testified and recorded in the SOD that she determined through interviews with Petitioner’s staff that if a staff member was not vaccinated, they were to wear an N95 respirator.  But Petitioner was not fit testing staff required to use an N95.  Staff observed wearing N95 respirators were interviewed and told the surveyors they knew they had to wear an N95 because they had not received all required doses of the vaccine, they were not fit-tested, but they were told how to wear the N95.  She also determined that Petitioner had provided no in-service training regarding use of N95 respirators.  Surveyor Slaughter observed that one certified nursing assistant (CNA) had cut the loops that go over the head for the N95 she was wearing and tied them around her ears because she said the straps were too tight.  CMS Exs. 1 at 80-81; Tr. I 226-35, 273-74.  Surveyor Slaughter’s observations are undisputed and credible.  On cross-examination, Surveyor Slaughter testified that she cited noncompliance under Tag F880 primarily because Petitioner was not fit testing staff for respirators, and she observed that a CNA had altered her respirator which could impact its effectiveness.  Tr. I 253.  She testified that she did not know the OSHA ETS requirements regarding N95 respirators or anything about the OSHA mini respiratory protection program.  Tr. I 260.  Surveyor Slaughter testified forthrightly that she did not know whether Petitioner met the requirements of the OSHA ETS.  Tr. I at 265.

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Petitioner’s administrator, Ray Vasquez, testified about the survey.  Tr. II 23-64.  Administrator Vasquez testified that an earlier version of Petitioner’s COVID-19 plan in evidence as P. Ex. 4 was probably adopted in March or April 2020.  He testified that Petitioner’s policy at the time of the survey provided Petitioner followed the OSHA ETS.  He identified P. Exs. 6 and 7 as the June 21, 2021 OSHA ETS Petitioner was following.  He testified that Petitioner was following the OSHA mini respiratory protection program as described in P. Ex. 7.  Administrator Vasquez testified that that staff were trained to use the N95 respirator, they received a new one each day, and the user seal check was used to verify the respirator had a good seal.  Tr. II 28-40, 47.  He agreed in response to my question, that fit testing was not done.  Rather, staff was trained on N95 use and user seal checks were used.  Tr. II 53-59.  Administrator Vasquez also testified, in response to my question, that staff were not medically cleared for use of an N95 respirator.  Tr. II 58.

b.  Analysis

The survey team made multiple allegations of noncompliance in this case.  CMS imposed a PICMP of $15,000 based only on the noncompliance cited under Tag F880 (42 C.F.R. § 483.80).  A DPNA for the period October 8 through 14, 2021, was also imposed but not based on any specific allegation of noncompliance.  CMS Ex. 3 at 2, 3.  I conclude that there was substantial noncompliance under Tag F880, which is a basis for the imposition of a PICMP, the reasonableness of which is addressed later in this decision.  The noncompliance under Tag F880 is also a basis for the imposition of a DPNA.  Therefore, it is not necessary to address any allegations of noncompliance in addition to that cited under Tag F880.

The SOD alleges that Petitioner was noncompliant under Tag F880 because Petitioner failed to implement a respiratory protection program that complied with OSHA respirator protection standards including medical evaluations, training, and fit testing for use of N95 respirators.  CMS Ex. 1 at 78.  Administrator Vasquez conceded during his testimony that Petitioner was not fit testing staff for use of an N95 respirator at the time of the survey and Petitioner was not obtaining medical clearance for staff to use respirators.  Tr. II at 53-59.  He testified that, at the time of the survey, Petitioner was following the OSHA COVID-19 ETS, specifically the mini respiratory program.  Tr. II at 28-40, 47; P. Exs. 4, 6, 7.

When enrolling in Medicare, a provider such as Petitioner, “attests . . . that . . . [it] is aware of, and abides by, all applicable statutes, regulations, and program instructions.”  42 C.F.R. § 424.510(d)(3).  Moreover, a provider such as Petitioner, must “operate and provide services in compliance with all applicable Federal, State, and local laws, regulations, and codes . . . .”  42 C.F.R. § 483.70(b).

In this case, the regulatory requirements the surveyors and CMS seek to enforce are found in the regulations promulgated by OSHA in 29 C.F.R. pt. 1910 subpt. U.

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The requirements the surveyors and CMS seek to enforce are not found in section 1819(b), (c), and (d) of the Act or the Medicare participation requirements for long-term care facilities promulgated by CMS at 42 C.F.R. pt. 483.

OSHA’s ETS applied to all employers “where any employee provided healthcare services or healthcare support services.”  29 C.F.R. § 1910.502(a)(1).  None of the exceptions provided for by 29 C.F.R. § 1910.502(b) applied to Petitioner.  Accordingly, the OSHA ETS was a federal regulation with which Petitioner was bound to comply.

Further, pursuant to 42 C.F.R. § 483.80, Petitioner “must establish and maintain an infection prevention and control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable diseases and infections.”  The regulation requires:

(a)  Infection prevention and control program.  The facility must establish an infection prevention and control program (IPCP) that must include, at a minimum, the following elements:

(1)  A system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing services under a contractual arrangement based upon the facility assessment conducted according to [42 C.F.R.] § 483.70(e) and following accepted national standards.

42 C.F.R. § 483.80(a)(1) (Emphasis added).  As discussed in my findings of fact, OSHA recognized that there were no enforceable standards protecting employees in healthcare settings from the specific risks associated with working with persons with suspected or known COVID-19 infection.  OSHA’s purpose in issuing the COVID-19 ETS was to establish national standards.  CMS Ex. 6 shows that the Texas state agency had issued guidance on July 20, 2021 regarding the COVID-19 infection in nursing facilities.  The Texas guidance specified that a nursing facility must implement “a respiratory protection program compliant with the OSHA respiratory protection standard for employees . . . [including] medical evaluations, training, and fit testing.”  CMS Ex. 6 at 34-35.  Therefore, the state agency guidance was not inconsistent with and required compliance with OSHA requirements including the OSHA COVID-19 ETS and the OSHA respiratory protection standard at 29 C.F.R. § 1910.134.  CMS Ex. 6 at 74.

I am bound to follow the provisions of the Act and the Secretary’s regulations and may not invalidate or choose not to comply with either a law or regulation on any ground.

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Jewish Home of E. Pa., DAB No. 2380 at 9; 1866ICPayday.com, L.L.C., DAB No. 2289 at 14; Sentinel Med. Laboratories, Inc., DAB No. 1762 at 9.  I find no authority granting me discretion to ignore or fail to apply regulations promulgated by another executive branch department, in a case such as this where OSHA has promulgated specific regulations that impose obligations on long-term care facilities enrolled in Medicare or Medicaid related to the protection of healthcare employees.

Based on the facts in this case, which are largely undisputed, I conclude that CMS has made a prima facie showing of violation of 42 C.F.R. § 483.80(a)(1) based on Petitioner’s failure to implement a written plan for the use of respirators consistent with the national standards established by OSHA in 29 C.F.R. § 1910.502.

Petitioner argues it had an IPCP as required by 42 C.F.R. § 483.80.  Petitioner argues that 42 C.F.R. § 483.80 does not refer to OSHA standards, but rather, to national standards.  Petitioner also argues that the CDC and the state agency guidance relied on by CMS recommend fit testing of an N95 respirator.  But neither the CDC nor the state agency require fit testing because both recognize situations where fit testing is not possible.  Petitioner acknowledges that the OSHA ETS was in effect at the time of the survey but argues it was following the mini-respiratory program authorized by OSHA.  Petitioner asserts that CMS has failed to show what OSHA respirator standards Petitioner did not meet.  P. Br. at 36-37; P. Reply at 18-21.

There is no allegation that Petitioner did not have an IPCP as required by 42 C.F.R. § 483.80(a)(1).  Petitioner also had its written plan that provided Petitioner would comply with OSHA’s COVID-19 ETS.  P. Ex. 4 at 1, Tr. II 28-40, 47.  Administrator Vasquez testified that Petitioner’s policy at the time of the survey was the same as that stated in P. Ex. 4, which was that Petitioner followed the OSHA ETS.  He identified P. Exs. 6 and 7 as the June 21, 2021 OSHA ETS.  But he testified that Petitioner was following the OSHA mini respiratory protection program as described in P. Ex. 7.  Administrator Vasquez testified that staff was trained to use the N95 respirator, they received a new one each day, and the user seal check was used to verify the respirator had a good seal.  Tr. II 28-40, 47.  He testified that medical evaluation and fit testing for use of respirators were not done.  Rather, staff was trained on N95 use and user seal checks were used.  Tr. II 53-59.  Surveyor Slaughter’s finding, based on her interview with staff, that only those staff not fully vaccinated were required by Petitioner to use N95 respirators, is unrebutted.

Petitioner’s argument that it was following the OSHA mini respiratory protection program is without merit because Petitioner has not shown it was eligible for that program.  OSHA provided in 29 C.F.R. § 1910.504, which established the mini respiratory protection program, that it only applied to respirator use under 29 C.F.R. § 1910.502(f)(4).  29 C.F.R. § 1910.504(a); P. Ex. 7 at 1.  OSHA provided in 29 C.F.R. § 1910.502(f)(4):

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(4) Use of respirators when not required.

(i) The employer may provide a respirator to the employee instead of a facemask as required by paragraph (f)(1) of this section.  In such circumstances, the employer must comply with § 1910.504.

(ii) Where the employer provides the employee with a facemask as required by paragraph (f)(1) of this section, the employer must permit the employee to wear their own respirator instead of a facemask.  In such circumstances, the employer must also comply with § 1910.504.

Pursuant to 29 C.F.R. § 1910.502(f)(2)(i) and (3)(i), an employer must provide a respirator to an employee and ensure it is correctly used if the employee will have exposure to a person with suspected or confirmed COVID-19.  Therefore, Petitioner could only follow OSHA’s mini respiratory protection program if none of its employees were possibly exposed to residents with known or suspected COVID-19 and Petitioner elected to provide or permit use of respirators by employees rather than facemasks.  Petitioner has not shown by a preponderance of the evidence that it was a COVID-19 free facility at the time of the survey and elected to provide respirators to staff rather than require the use of facemasks.

I conclude:

Petitioner was required by 29 C.F.R. § 1910.502(a)(1), (f)(2) and (3) to provide respirators to all staff with exposure to residents with suspected or known COVID-19.

The preponderance of the evidence shows that Petitioner only required staff who were not fully vaccinated to use a respirator.  But, pursuant to 29 C.F.R. § 1910.502(a)(4) and (c)(4)(ii), Petitioner could only claim an exemption to the requirement to provide respirators to fully vaccinated staff if they were in a well-defined area where there was no reasonable expectation that there would be any person suspected or confirmed to have COVID-19.  Petitioner has not shown by a preponderance of the evidence that it met the requirements for a well-defined area.

Medical evaluation and fit testing are required by 29 C.F.R. § 1910.134(e) and (f) before Petitioner could require that staff use a respirator if they might be exposed to a resident with suspected or known COVID-19.  The preponderance of the evidence shows Petitioner was not doing medical evaluation for respirator use or fit testing.

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Petitioner violated 42 C.F.R. § 483.80(a)(1) because it failed to follow the national standards established by OSHA’s COVID-19 ETS.

Petitioner did not violate 29 C.F.R. § 1910.502(c)(1) and 42 C.F.R. § 483.80(a)(2) because at the time of the survey according to the credible testimony of Administrator Vasquez, Petitioner had a written policy to follow the OSHA COVID-19 ETS.  P. Ex. 4.

But the preponderance of the evidence shows Petitioner failed to correctly implement its policy because it attempted to follow the OSHA mini respiratory protection program (29 C.F.R. § 1910.504) which Petitioner has failed to show by a preponderance of the evidence was applicable in Petitioner’s facility.  Specifically, Petitioner has failed to show it had no residents with suspected or known COVID-19 infection at the time of the survey.

Petitioner is correct that both the CDC and Texas guidance in evidence (CMS Exs. 6, 7) refer to situations where those agencies would recognize exceptions to the requirement for staff to use respirators.  However, the CDC guidance, which predated OSHA’s issuance of its COVID-19 ETS, was not a regulation and, unlike the OSHA regulations establishing the ETS, was not enforceable as law.

The Texas guidance required that Petitioner follow OSHA requirements.  CMS Ex. 6 at 34.  The Texas guidance recognized that staff could not wear a respirator when none was available and specified that if provided staff should be fit-tested.  CMS Ex. 6 at 38.  But Texas also recognized that respirators might be used without proper fit testing and specified fit testing should be performed as soon as possible.  CMS Ex. 6 at 57.  The inconsistencies in the Texas guidance support my conclusion that the OSHA COVID-19 ETS are regulations establishing the national standard with which Petitioner was bound to comply.

Petitioner has failed to rebut, by a preponderance of the evidence, the CMS prima facie showing that the violation of 42 C.F.R. § 483.80(a)(1) posed a risk for more than minimal harm because Petitioner failed to require all staff with exposure to residents with suspected or known COVID-19 to wear a respirator only after medical evaluation and fit testing.

Although not specifically alleged as a defense by Petitioner, some arguments could be construed to be that the government should be estopped from imposing an enforcement remedy based on the noncompliance under Tag F880.  P. Reply.  I recognize Petitioner’s challenges reconciling seemingly inconsistent and conflicting guidance from the CDC and the state agency, at least prior to the issuance of OSHA’s COVID-19 ETS.  But as a matter of law, estoppel against the federal government, if available at all, is presumably unavailable absent “affirmative misconduct,” such as fraud.  See, e.g., Pac. Islander

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Council of Leaders, DAB No. 2091 at 12 (2007); Office of Pers. Mgmt. v. Richmond, 496 U.S. 414, 421 (1990).  There is no evidence suggesting fraud on the part of the CDC or the state agency.  Furthermore, as of June 21, 2021, more than two months prior to the completion of the survey in this case, the OSHA ETS clearly resolved or simply eliminated prior inconsistent nonbinding CDC guidance.  Petitioner admits it knew about the ETS and it was following the mini respiratory protection program, which I have concluded Petitioner has failed to show was applicable in its case.  Therefore, Petitioner could not have been acting in detrimental reliance upon guidance of the CDC or the state agency when the survey in this case occurred.

6.  Reasonable enforcement remedies in this case are a PICMP of $15,000 and a DPNA from October 9 to 14, 2021, based on noncompliance under Tag F880.

I have concluded that Petitioner violated 42 C.F.R. § 483.80 and the violation posed a risk for more than minimal harm to Petitioner’s residents.

If a facility is not in substantial compliance with program participation requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406(a), including a DPNA and a CMP.  CMS may impose a per-day CMP for the number of days that the facility is not in compliance or a per-instance CMP for each instance that a facility is not in substantial compliance.  42 C.F.R. § 488.430(a).  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.  But as done in this case, CMS is also authorized to impose a PICMP in the range of $2,259 to $22,584.  42 C.F.R. § 488.438(a)(1)(ii), (2); 45 C.F.R. § 102.3 (Table) (2021).

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; CarePlex of Silver Spring, DAB No. 1683 at 14-16 (1999); Capitol Hill Cmty. Rehab. & Specialty Care Ctr., DAB No. 1629 (1997).  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.  If I conclude, as I have in this case, that there is a basis for the imposition of an enforcement remedy and the remedy proposed is a CMP, my authority to review the reasonableness of the CMP is limited by 42 C.F.R. § 488.438(e).  The limitations are that I may:  (1) not set the CMP at zero or reduce it to zero; (2) not review the exercise of discretion by CMS in selecting to impose a CMP; and (3) 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

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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.  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.

Based on my consideration of the regulatory factors, I conclude that the $15,000 PICMP is a reasonable enforcement remedy.  I also conclude that the DPNA from October 9 through 14, 2021, was reasonable.  Petitioner had one prior citation of noncompliance under Tag F880 in May 2020, for which no enforcement remedy was imposed.  CMS Ex. 53 at 1.  Petitioner does not argue that its financial condition affects its ability to pay the $15,000 PICMP.  Petitioner’s noncompliance was serious.  The OSHA findings in its rulemaking issuing the ETS are convincing evidence of the seriousness posed by COVID-19 infection.  86 Fed. Reg. at 32,378-79, 32,381-83.  Petitioner’s failure to comply with the ETS by requiring all staff in contact with residents with suspected or known COVID-19 to use a respirator after medical clearance and fit testing, exposed Petitioner’s staff and residents to the grave danger identified by OSHA from spreading COVID-19 in the facility.  Petitioner was culpable because Petitioner was aware of OSHA’s COVID-19 ETS but failed to identify that it was to comply with the ETS requirements and that it was not eligible for the mini respiratory protection program.  Petitioner’s management failed to adequately supervise implementation of the OSHA ETS.

Petitioner argues that CMS failed to present evidence of how it considered the regulatory factors in determining to assess the CMP.  P. Br. at 37-38.  However, it is my task to provide de novo review of the factors.  CMS’s review or how it weighed the factors is simply not relevant to me.  “The Board has repeatedly held that in a proceeding to challenge CMS’s determination of noncompliance and imposition of a CMP, an ALJ or the Board properly presumes that CMS considered the regulatory factors and that those factors support the amount imposed.”  Pinecrest Nursing & Rehab. Ctr., DAB No. 2446 at 23 (2012).

Based on my consideration of the regulatory factors and the evidence, I conclude that the PICMP of $15,000 for the noncompliance under Tag F880 is reasonable even though it is

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above the middle of the authorized range.  The noncompliance under Tag F880 is also a basis for the imposition of the DPNA from October 9 through 14, 2021, and reasonable.28

III.     Conclusion

For the foregoing reasons, because the survey was conducted in violation of the Act, the noncompliance cited by the survey is not a basis for the imposition of any enforcement remedy.

If on appeal the statutory violation is overlooked or excused, I conclude that Petitioner was not in substantial compliance with program participation requirements due to a violation of 42 C.F.R. § 483.80(a)(1), that posed a risk for more than minimal harm.  Reasonable enforcement remedies are a PICMP of $15,000 and a DPNA from October 9 through 14, 2021.