Signature HealthCARE at Jackson Manor Rehab and Wellness Center, DAB CR5890 (2021)

DECISION

Signature HealthCARE at Jackson Manor Rehab and Wellness Center (Petitioner or “the facility”) challenges the determination by the Centers for Medicare & Medicaid Services (CMS) to impose separate per‑day civil monetary penalties (CMPs) based on Petitioner’s noncompliance with Medicare participation requirements on November 30 and December 7, 2020, and January 25, 2021.  For the reasons discussed below, Petitioner has demonstrated, by a preponderance of the evidence, that it was not out of substantial compliance with 42 C.F.R. § 483.80(g)(1), (2) on the aforementioned dates.  I reverse the findings of noncompliance and the imposition of remedies with respect to those deficiencies.

I.  Background

The Social Security Act (Act) establishes requirements for skilled nursing facility (SNF) participation in the Medicare program and authorizes the Secretary of Health and Human Services (“the Secretary”) to promulgate regulations implementing those statutory provisions.  See 42 U.S.C. § 1395i-3; 42 C.F.R. pts. 483 and 488.  To participate in the

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Medicare program, an SNF must maintain substantial compliance with program participation requirements.  In order to be in substantial compliance, an SNF’s deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301.  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  Id.

The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with participation requirements.  42 U.S.C. § 1395aa(a); 42 C.F.R. §§ 488.10, 488.20.  The Act and its implementing regulations require that facilities be surveyed on average every twelve months, and more often if necessary, to ensure that identified deficiencies are corrected.  42 U.S.C. § 1395i‑3(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308.  CMS may impose a per-day CMP for the number of days an SNF is not in substantial compliance, or a per-instance CMP for each instance of the SNF’s noncompliance.  42 U.S.C. § 1395i-3(h)(2)(B)(ii); 42 C.F.R. § 488.430(a).  If CMS imposes a remedy based on a noncompliance determination, then the facility may request a hearing before an administrative law judge to challenge the noncompliance finding and enforcement remedy.  42 U.S.C. §§ 1320a-7a(c)(2), 1395i‑3(h)(2)(B)(ii); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).

In light of the COVID-19 pandemic that has had a disproportionately devastating impact on this country’s nursing home population, CMS published an interim final rule in May 2020 in which it established the following new Medicare participation requirement:

[W]e are revising our requirements by adding a new provision at § 483.80(g)(1), to require facilities to electronically report information about COVID-19 in a standardized format specified by the Secretary.  The report includes, but is not limited to, information on:  Suspected and confirmed COVID-19 infections among residents and staff, including residents previously treated for COVID-19; total deaths and COVID-19 deaths among residents and staff; personal protective equipment and hand hygiene supplies in the facility; ventilator capacity and supplies available in the facility; resident beds and census; access to COVID-19 testing while the resident is in the facility; staffing shortages; and other information specified by the Secretary.

85 Fed. Reg. 27,550, 27,601-602 (May 8, 2020); see Id. at 27,627 (text of 42 C.F.R. § 483.80(g)(1)).  CMS further explained that “facilities are required to provide the information . . . at a frequency specified by the Secretary, but no less than weekly to the Center for Disease Control and Prevention’s (CDC) National Healthcare Safety Network (NHSN).”  Id. at 27,601; see Id. at 27,627 (text of 42 C.F.R. § 483.80(g)(2)).

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In advance of publication of the interim final rule, CMS issued a policy memorandum, QSO-20-29-NH (Interim Final Rule Updating Requirements for Notification of Confirmed and Suspected COVID-19 Cases Among Residents and Staff in Nursing Homes), dated May 6, 2020, addressing the new participation requirement.  See CMS Ex. 13; P. Ex. 15; https://www.cms.gov/files/document/qso-20-29-nh.pdf (last visited June 22, 2021).  CMS discussed that it had created a new “F-Tag” for enforcement of 42 C.F.R. § 483.80(g)(1), (2) (F884), explaining:

F884:  COVID-19 Reporting to CDC as required at § 483.80(g)(1)-(2)

Review for F884 will be conducted offsite by CMS Federal surveyors (state surveyors should not cite this F-tag).  Following an initial reporting grace period granted to facilities, CMS will receive the CDC NHSN COVID-19 reported data and review for timely and complete reporting of all data elements.  Facilities identified as not reporting will receive a deficiency citation at F884 on the CMS-2567 with a scope and severity level at an F (no actual harm with a potential for more than minimal harm that is not an Immediate Jeopardy [IJ] and that is widespread; this is a system failure with the potential to affect a large portion or all of the residents or employees), and be subject to an enforcement remedy as described below.

CMS Ex. 13 at 4; P. Ex. 15 at 4.  On September 2, 2020, CMS published another interim final rule that addressed, in pertinent part, the imposition of CMPs for deficiencies cited under 42 C.F.R. § 483.80(g)(1), (2).  85 Fed. Reg. 54,820, 54,823-825; see Id. at 54,873 (text of 42 C.F.R. § 488.447(a)-(d)).  CMS explained that “a minimum $1,000 CMP will be imposed for the first occurrence of noncompliance,” and that “[f]or each subsequent time the facility fails to report the requisite COVID-19 related data, the amount of the CMP imposed will be increased by $500.”  Id. at 54,824.  CMS reported that facilities “are offered an opportunity for Independent Informal Dispute Resolution [IIDR] under § 488.431,” and that IIDR “may be requested for reasons, such as technical difficulties that should be adequately documented, that may have prevented the facility from submitting its report in a timely manner.”  Id. at 54,824.

With respect to the instant case, on November 30, 2020, CMS issued the first of nine successive weekly notices, each with a corresponding essentially identical Form CMS-2567 (Statement of Deficiencies), notifying Petitioner that it was not in substantial

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compliance with 42 C.F.R. § 483.80(g)(1), (2).1   See P. Exs. 1 (notices dated November 30, December 7, 14, 21, and 28, 2020, and January 4, 11, 19, and 25, 2021); 2 (corresponding Form CMS-2567s).  CMS cited each deficiency at the “F” level of scope and severity2 and imposed a progressively increasing CMP for each single-day instance of noncompliance.  See P. Ex. 2 (imposing a CMP “of $1,500 for (1) one day, November 30, 2020,” and a progressively increasing CMP imposed each week, culminating with a CMP “of $5,500 for one (1) day, January 25, 2021”).

On January 28, 2021, Petitioner, through counsel, timely requested a hearing with respect to the deficiencies at issue.  CMS filed a pre-hearing brief and motion for partial dismissal (CMS Br.) and 14 proposed exhibits (CMS Exs. 1-14), and Petitioner filed a brief and motion for summary judgment (P. Br.) and 17 proposed exhibits (P. Exs. 1-17).  Thereafter, in response to a June 15, 2021 order directing the parties to provide a status

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update regarding any pending IIDR requests,3 Petitioner filed P. Exs. 18-21.4   In the absence of any objections, I admit all proposed exhibits into the evidentiary record.

Petitioner submitted the written direct testimony of two witnesses (P. Exs. 3, 4), and CMS did not request to cross-examine these witnesses.  Therefore, a hearing is unnecessary for the purpose of cross-examination of any witnesses.  Pre-Hearing Order §§ 12-14.  The record is closed, and I issue this decision on the merits.5

II.  Issue

The issue presented is:

Whether Petitioner was in substantial compliance with 42 C.F.R. § 483.80(g)(1), (2) on November 30 and December 7, 2020, and January 25, 2021.6

III.  Discussion7

1. Petitioner concedes that it did not electronically file COVID-19 reports through the NHSN on November 30 and December 7, 2020, and January 25, 2021.

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2. Petitioner’s former Administrator had NHSN access credentials and electronically filed Petitioner’s COVID-19 reports through the NHSN until on or about November 13, 2020.

3. Petitioner installed an interim Administrator on November 16, 2020.

4. The interim Administrator first attempted to obtain NHSN access credentials on November 16, 2020, and as of at least February 1, 2021, had not yet obtained access credentials.

5. As of February 2, 2021, Petitioner’s Director of Nursing had not yet obtained NHSN access credentials, even though she had pursued access credentials for a number of weeks preceding February 2, 2021.

6. CMS does not dispute Petitioner’s claims that it was unable to obtain access credentials for the NHSN beginning on November 16, 2020.

7. Pursuant to 42 C.F.R. § 483.80(g)(1), (2), a facility must electronically submit COVID-19 reports through the NHSN; no other means of COVID-19 reporting is authorized by the regulation.

8. Because the CDC had not granted Petitioner access to the NHSN, Petitioner had no means to electronically submit reports to the NHSN on November 30 and December 7, 2020, and January 25, 2021.

9. Petitioner has shown, by a preponderance of the evidence, that it was not out of substantial compliance with the participation requirement at 42 C.F.R. § 483.80(g)(1), (2) on November 30 and December 7, 2020, and January 25, 2021.

The new regulatory participation requirement at 42 C.F.R. § 483.80(g)(1), (2), at the time the deficiencies were cited, stated the following:

(g) COVID-19 reporting.  The facility must—

(1) Electronically report information about COVID-19 in a standardized format specified by the Secretary.  This report must include but is not limited to—

(i) Suspected and confirmed COVID-19 infections among residents and staff, including residents previously treated for COVID-19;

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(ii) Total deaths and COVID-19 deaths among residents and staff;

(iii) Personal protective equipment and hand hygiene supplies in the facility;

(iv) Ventilator capacity and supplies in the facility;

(v) Resident beds and census;

(vi) Access to COVID-19 testing while the resident is in the facility;

(vii) Staffing shortages; and

(viii) Other information specified by the Secretary.

(2) Provide the information specified in paragraph (g)(1) of this section at a frequency specified by the Secretary, but no less than weekly to the Centers for Disease Control and Prevention's National Healthcare Safety Network.  This information will be posted publicly by CMS to support protecting the health and safety of residents, personnel, and the general public.

Thus, for a facility to comply with section 483.80(g)(1), (2), it must “electronically report” its information via the NHSN.  42 C.F.R. § 483.80(g)(1), (2).

CMS, in the approximately two and a half pages of its brief devoted to this issue, acknowledged Petitioner’s complaints that it was unable to electronically report information via the NHSN, stating:

[Petitioner] alleges that it could not comply with the reporting requirement due to technical problems that prevented submission of reports to NHSN.  [Petitioner] describes a change of facility administrators and its efforts to obtain new reporting credentials that contributed to the nursing home’s reporting failures.  The nursing home submitted the same arguments with its requests for IIDR review.

The evidence submitted by [Petitioner] here and in its IIDR requests does not prove that it timely submitted the required COVID-19 data during the weeks from November 30, 2020

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to January 25, 2021.  [Petitioner] admits that it did not comply with reporting requirements.  Therefore, CMS was [sic] correctly cited the nursing home’s noncompliance and imposed appropriate remedies.

CMS Br. at 5 (internal citations omitted).  Thus, while CMS did not dispute Petitioner’s claims that it lacked access to the NHSN, CMS nonetheless argues that such “technical problems” do not excuse Petitioner from reporting to the NHSN.  CMS Br. at 5.  CMS’s current position is inconsistent with its statement during the rulemaking process that “technical difficulties . . . that may have prevented the facility from submitting its report in a timely manner” would be considered as a basis for rescinding a cited deficiency.  See 85 Fed. Reg. at 54,824.

Petitioner’s statement of undisputed material facts is similar to the facts it presented in its IIDR requests, in which it detailed an inability to obtain NHSN access credentials.  P. Br. at 5-8; see CMS Exs. 11, 12.  Petitioner explained that it had a history of full compliance with section 483.80(g)(1)-(2) until its former Administrator (who had NHSN access) left his position on November 13, 2020.  Petitioner’s new interim Administrator, Robert Durham, assumed that role on November 16, 2020, and reported that he requested NHSN access credentials that same day.  P. Ex. 3 at 2; see P. Ex. 8 at 1.  Mr. Durham testified that despite continued follow-up, he had not yet received NHSN credentials as of at least February 1, 2021.8   P. Ex. 3 at 2-4; see P. Exs. 8, 9 (email correspondence with the NHSN dated November 16, 23, and 28, 2020).  Mr. Durham reported (with unattributed sourcing), “NHSN apparently was in the process of upgrading its credentialing requirements to what they called ‘SAMS-3,’ which is an enhanced level of security needed to submit not only the aggregated COVID-19 data CMS requires, but also resident-specific data regarding COVID-19 testing.”  P. Ex. 3 at 2.

Because Mr. Durham was serving as an interim Administrator, he asked Petitioner’s Director of Nursing, Rebecca Mills, RN, to also request NHSN credentials.  P. Ex. 3 at 2.  Ms. Mills testified that the “NHSN requested that [she] submit a certified copy of her birth certificate,” and that she “immediately submitted a written request for that documentation to the West Virginia vital records office,” only to later discover that the county courthouse had been “closed for several weeks during December, 2020 because of the COVID-19 pandemic.”  P. Ex. 4 at 2; see P. Ex. 10 (undated copy of birth certificate request).  Ms. Mills testified that after she submitted her birth certificate to the NHSN in January 2021, the NHSN “then requested copies of [her] current utility bills so it could verify [her] home address.”  P. Ex. 4 at 2.  Ms. Mills testified that she complied with this request, and that as of January 28, 2021, a “representative of NHSN . . . confirmed that

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NHSN had all of [her] information[,] there was nothing more that [she] needed to do[,] but that NHSN was experiencing delays in processing reporting credentials of at least three to four weeks.”  P. Ex. 4 at 2; see P. Ex. 13 at 1 (January 28, 2021 email message from Ms. Mills).

CMS had an opportunity to dispute Petitioner’s statement of these facts; however, CMS neither did so nor sought to cross-examine Mr. Durham or Ms. Mills.  Pre-Hearing Order § 9(e) (“The party opposing a motion for summary judgment must file its response within 30 days of receipt of the motion . . . and should come forward with specific evidence showing that facts are in dispute.”).  In fact, CMS recognized that Petitioner had claimed “technical problems” and that it lacked NHSN access credentials, yet explained that Petitioner was nonetheless still required to submit electronic reports through the NHSN pursuant to 42 C.F.R. § 483.80(g)(1)-(2).  CMS Br. at 5.  In the absence of raising any factual disputes, CMS has not challenged Petitioner’s claims that it had not been granted the necessary credentials to access the NHSN.

Petitioner has presented credible and unrefuted evidence that its interim Administrator initially attempted to gain NHSN access credentials on November 16, 2020, and that it diligently continued to pursue NHSN access credentials for both its interim Administrator and Director of Nursing through at least February 1, 2021.  P. Exs. 3, 4.  CMS has not offered any evidence, much less argued, that Petitioner’s inability to access the NHSN was due to any fault of its own.  Rather, CMS simply argues that because Petitioner did not electronically submit the required COVID-19 reports via the NHSN, it “correctly cited the nursing home’s noncompliance and imposed appropriate remedies.”  CMS Br. at 5.  I disagree.

CMS cannot require compliance with a participation requirement when such compliance is utterly unattainable because a government entity (the CDC) had not authorized access to its reporting system.  Even after many weeks of effort, Petitioner’s interim Administrator and Director of Nursing had not yet obtained access credentials for the NHSN.  Without such credentials, it was impossible for Petitioner to electronically file the required reports through the NHSN.  CMS’s position in its briefing fails to take into account that it informed the public that it would take such “technical difficulties” into account when assessing noncompliance.9  Compare CMS Br. at 5 (acknowledging Petitioner’s reports of “technical problems” but nonetheless requiring compliance with 42 C.F.R. § 483.80(g)(1), (2)) with 85 Fed. Reg. at 54,824 (explaining that “technical difficulties” may be a basis for rescinding a cited deficiency).

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For the foregoing reasons, Petitioner has shown by a preponderance of the evidence that it was not out of substantial compliance with 42 C.F.R. § 483.80(g)(1), (2).  I reverse CMS’s imposition of remedies based for the deficiencies cited on November 30 and December 7, 2020 and January 25, 2021.

IV.  Conclusion

For the reasons discussed above, I reverse CMS’s determinations of noncompliance and imposition of remedies for the deficiencies cited on November 30 and December 7, 2020, and January 25, 2021.

1. CMS issued the initial noncompliance determination on November 23, 2020, at which time it imposed a $1,000 CMP for one day of noncompliance.  P. Exs. 1 at 1; 2 (Part 1) at 1-6.  Petitioner did not raise this deficiency in its request for hearing.  See 42 C.F.R. § 498.40(b).  Although Petitioner references this deficiency in its brief and motion for summary judgment, it neither amended its request for hearing to include this deficiency nor alleged good cause for extending the time for doing so.  42 C.F.R. § 498.40(c)(2).  Petitioner is correct that the factual basis for the citation of this deficiency mirrors the other deficiencies that were the subject of its request for hearing; however, Petitioner did not appeal this deficiency.  42 C.F.R. § 498.40(b).  Aside from Petitioner’s failure to timely raise this deficiency in a request for hearing as required by section 498.40(b), it would be fundamentally unfair to allow Petitioner to belatedly raise a new deficiency after CMS had already filed its pre-hearing exchange.  See CMS Br. at 1 n.1 (“It appears that the nursing home is not appealing the November 23, 2020 remedy.  CMS notes that had the nursing home included the November 23, 2020 CMP in this appeal, the appeal of that CMP would have been untimely because it was not filed within 60 days of the date of the Imposition Notice . . . .”).
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2. Scope and severity levels are used by CMS and state survey agencies when selecting remedies.  The scope and severity level is designated by letters A through L.  Pub. 100-7, State Operations Manual (SOM), chap. 7, § 7400.3 (Selection of Remedies), “Matrix for Scope & Severity” (table) (Rev. 185, eff. Nov. 16, 2018) (current version and applicable at the time of the survey at issue); see also 42 C.F.R. § 488.408.  As relevant here, a scope and severity level of “F” indicates a widespread deficiency that posed a potential for more than minimal harm to resident health and safety.
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3. Although 42 C.F.R. § 488.431(a)(1) states that IIDR review will be completed within 60 days of a facility’s request, IIDR of the instant deficiencies remains pending more than 20 weeks after CMS filed its pre-hearing exchange and nearly 16 weeks after Petitioner filed its pre-hearing exchange.  In an order dated June 15, 2021, I informed the parties that a decision was forthcoming.  CMS neither provided notice that the IIDR process had been completed with respect to the three deficiencies at issue, nor did it  request a stay of proceedings to allow for resolution of the IIDR process.
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4. I note that P. Ex. 21 pertains to a deficiency that was not raised in Petitioner’s request for hearing.
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5. As an in-person hearing to cross-examine witnesses is not necessary, it is unnecessary to further address Petitioner’s motion for summary judgment.  Nonetheless, I note that  CMS did not file a response to Petitioner’s motion for summary judgment, and therefore, has not disputed Petitioner’s statement of undisputed material facts.
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6. I do not address deficiencies that CMS rescinded through the IIDR process.
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7. Findings of fact and conclusions of law are in bold and italics.
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8. Mr. Durham did not date his testimony; the last date he referenced in his testimony is February 1, 2021.
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9. I again note that 42 C.F.R. § 483.80(g)(1), (2) requires “electronic reporting” via the NHSN.  Without an alternative means to report COVID-19 data, a facility without access to the NHSN cannot comply with 42 C.F.R. § 483.80(g)(1), (2) through any other reporting means, such as email or facsimile submission.
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