Masonic Home of Shelbyville CR6119 (2022)

DECISION

Petitioner, Masonic Home of Shelbyville, is a long-term-care facility, located in Shelbyville, Kentucky, that participates in the Medicare program.  The Centers for Medicare and Medicaid Services (CMS) determined that, for the week of September 14 through 20, 2020, the facility did not submit its COVID-19 data to the Centers for Disease Control and Prevention (CDC), as required by 42 C.F.R. § 483.80(g)(1)-(2).  CMS imposed the minimum civil money penalty (CMP):  $1,000 per day for one day of substantial non-compliance with the reporting requirement. 

Petitioner appealed. 

For the reasons set forth below, I find that, on September 21, 2020, the facility was not in substantial compliance with section 483.80(g), and the penalty imposed (which is the minimum) is reasonable.

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Background

The Social Security Act (Act) sets forth requirements for nursing facilities to participate in the Medicare program and authorizes the Secretary of Health and Human Services to promulgate regulations implementing those statutory provisions.  Act § 1819.  The Secretary’s regulations are found at 42 C.F.R. Part 483.  To participate in the Medicare program, a nursing facility must maintain substantial compliance with program requirements.  To be in substantial compliance, a facility’s deficiencies may pose no greater risk to resident health and safety than “the potential for causing minimal harm.”  42 C.F.R. § 488.301. 

The Covid reporting requirements.  The COVID-19 pandemic disproportionately affected this country’s nursing home population.  Responding to the crisis, on May 8, 2020, CMS published an interim final rule, amending its infection control regulation to add Covid-specific requirements.  85 Fed. Reg. 27,550, 27,601-602 (May 8, 2020). 

Among other provisions, the new rule adds COVID-19 reporting requirements.  Weekly, facilities must electronically report to the Centers for Disease Control and Prevention Healthcare Safety Network, “in a standardized format specified by the Secretary,” the following information: 

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

(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;

(viii)  the COVID-19 vaccine status of residents and staff, including total numbers of residents and staff, numbers of residents and staff vaccinated, numbers of each dose of COVID-19 received, and COVID-19 vaccination adverse events; and

(ix)    therapeutics administered to residents for treatment of COVID-19. 

42 C.F.R. § 483.80(g)(1) and (2).

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Before it published the 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.  CMS Ex 7.  The memorandum explains that federal (not state) surveyors would review, offsite, for facility compliance with the Covid-reporting rule.  After an initial grace period, CMS would “review for timely and complete reporting of all data elements.”  CMS would cite a deficiency under section 483.80(g)(1)-(2) (F884) on form CMS-2567 (statement of deficiencies) for facilities identified as not reporting.  The scope and severity level would be F (widespread substantial noncompliance that causes no actual harm with the potential for more than minimal harm).  CMS Ex. 7 at 4. 

CMS subsequently published another rule, authorizing CMS to impose CMPs for noncompliance with section 483.80(g)(1)-(2) and setting the amounts of those CMPs.  42 C.F.R. § 488.447; see 85 Fed. Reg. 54,820, 54,823-825 (Sept. 2, 2020).  The regulation sets a minimum penalty of $1,000, to which an additional $500 is added for each subsequent occurrence.  42 C.F.R. § 488.447(a)(1)-(2).  Compliance is assessed weekly.  42 C.F.R. § 488.447(c). 

Here, in a notice dated September 21, 2020, CMS advised Petitioner that it had reviewed the Center for Disease Control’s National Health Safety Network system data for the facility to determine whether it complied with section 483.80(g)(1)-(2).  CMS determined that the facility was not in substantial compliance with that regulation because it failed to report complete information “about COVID-19 in the standardized format and frequency” required.  CMS Ex. 1 at 1.  Specifically, between September 14, 2020, and September 20, 2020, the facility had not reported.  CMS Ex. 2. 

CMS imposed a $1,000 penalty for one day of substantial noncompliance (September 21, 2020).  CMS Ex. 1 at 2. 

Petitioner timely requested a hearing before an administrative law judge.¹

CMS has filed a pre-hearing brief (CMS Br.) with 14 exhibits (CMS Exs. 1-14).  Petitioner responded with its own pre-hearing brief (P. Br.) and three exhibits (P. Exs. 1-3).  In the absence of any objections, I admit into evidence CMS Exs. 1-14 and P. Exs. 1-3.

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Decision on the written record.  My standing order directed the parties to exchange, as a proposed exhibit and in the form of an affidavit or written declaration, the written direct testimony of any proposed witness.  Standing Order at 3 (¶ 4(c)(4)) (November 20, 2020).  The order also directed each party to indicate whether it wanted to cross-examine the opposing party’s witnesses.  Order at 5 (¶ 9).  The order pointed out that a hearing would be necessary only if a party files admissible, written direct testimony, and, in compliance with the order, the opposing party asks to cross-examine.  Order at 5 (¶ 10). 

CMS lists no witnesses.  Petitioner lists one witness and provides her written declaration, P. Ex. 3.  However, CMS has not asked to cross-examine Petitioner’s witness.  Because there are no witnesses to be cross-examined, an in-person hearing would serve no purpose, and I may decide this case based on the written record without considering whether the standards for summary judgment are met.²

Issues

The sole issue before me is whether, on September 21, 2020, the facility was in substantial compliance with 42 C.F.R. § 483.80(g)(1)-(2).  Because CMS has imposed the minimum penalty, it is, by law, reasonable.  42 C.F.R. § 483.447(a)(1). 

Discussion

1. The facility was not in substantial compliance with 42 C.F.R. § 483.80(g)(1)-(2) because, for the week of September 14 through 20, 2020, the facility did not submit its Covid-19 data to the Centers for Disease Control and Prevention (CDC) as required.³

As noted above, section 483.80(g) requires facilities to report, electronically, their COVID-19 data “no less than weekly,” which CMS determined means “at least once every seven days.”  Each Monday, CMS reviews the data submitted from the previous week.  CMS Ex. 7 at 3-4.  Here, on Monday, September 21, 2020, CMS reviewed the data from the week of September 14 through 20, 2020.  Review of the data showed that Petitioner did not submit the required data for the weeks ending September 13 and

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September 20.  CMS Ex. 5.  CMS submits screenshots of the data files that the CDC sent to CMS on September 21.  They show that Petitioner submitted the required information weekly, through September 6, 2020, but not thereafter.  CMS Ex. 5 at 2-3.  An additional data file confirms that the CDC did not receive submissions from Petitioner for the weeks ending September 13 and 20, 2020.⁴

CMS did not impose a penalty for Petitioner’s failing to submit data for the week ending September 13, 2020, but imposed the minimum penalty for the week ending September 20, 2020.

Petitioner, however, maintains that Janie Cunningham, the facility’s administrator, submitted the required data, and submits Administrator Cunningham’s written affidavit.  Administrator Cunningham indicates that she “personally” entered the COVID-19 data into the system weekly and reported to her supervisor or others.  P. Ex. 3 at 1 (Cunningham Decl. ¶¶ 3, 4).  According to Administrator Cunningham, she “followed this exact same process for the week of September 14, 2020-September 20, 2020.”  P. Ex. 3 at 1 (Cunningham Decl. ¶ 7).

She claims that she did not realize, until September 24, that the data was not entered, so she resubmitted the data, which was accepted as “modified.”  She took a screenshot of the modification confirmation, which Petitioner submitted as P. Ex. 1.  P. Ex. 3 at 1 (Cunningham Decl. ¶¶ 8, 9).  This is puzzling because the screenshot submitted indicates the “date modified” as 9/4/2020, which suggests that it was data for an entirely different week.  P. Ex. 1.

Administrator Cunningham also claims that, when she logged in on September 25, the modified data was no longer there, despite her “documented modification on September 24.”  P. Ex. 3 at 1 (Cunningham Decl. ¶ 10); P. Ex. 2 at 2.

Petitioner cites this as evidence that the reporting system was not working.  But the evidence does not show what Petitioner claims it shows.  It shows that data was modified on September 4, not September 24.  It also shows that, on September 25, 2020, Petitioner ultimately submitted the data required for the week ending September 20.  P. Ex. 2 at 1.  A screenshot of the CDC data also indicates that the data was created on September 25, 2020, at 10:50 a.m. and that it reports the facility’s “counts” as of September 17, 2020.  CMS Ex. 4 at 5. 

Finally, Petitioner points to emails that Administrator Cunningham exchanged with CDC staff on September 24, 2020.  However, the emails show that staff responded to her

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September 24 inquiry on that same day and advised her, in some detail, how to submit her data.  CMS Ex. 4 at 9.  They do not show that the system was not working.  

Claiming that the system had glitches does not relieve Petitioner of its obligation to demonstrate that it timely submitted the required data, and, here, no evidence suggests that it did so.  Petitioner offers no screenshot confirming that it “successfully saved record” or that September 17 was the “date created” for its report.  See CMS Ex. 9 at 35, 66.  Nor has Petitioner produced any of the facility’s internal records that Administrator Cunningham describes (calendared submissions, QA system), which might support Petitioner’s claim to have submitted the data earlier.  See P. Ex. 3 at 1 (Cunningham Decl. ¶ 4). 

Because no evidence establishes that the facility timely submitted its COVID-19 data for the week September 14 through 20, 2020, it was not in substantial compliance with 42 C.F.R. § 483.80(g)(1)-(2).  Because CMS has imposed the minimum penalty, it is, by law, reasonable. 

Conclusion

On September 21, 2020, the facility was not in substantial compliance with 42 C.F.R. § 483.80(g)(1)-(2).  The penalty imposed is reasonable.

Endnotes