Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Consulate Health Care of Lakeland
(CCN: 10-5482),

Petitioner,
v.
Centers for Medicare & Medicaid Services.
Docket No. C-12-1252
Decision No. CR3315
Date: August 1, 2014
DECISION

Petitioner, Consulate Health Care of Lakeland, was not in substantial compliance with
program participation requirements from February 27, 2012 through June 10, 2012.
There is a basis for the imposition of enforcement remedies. A mandatory denial of
payments for new admissions (DPNA) was in effect from May 27, 2012 through June 10,
2012. A civil money penalty (CMP) of $150 per day from March 30, 2012 through May
10, 2012 and $250 per day from May 11, 2012 through June 10, 2012, a total CMP of
$14,050, is a reasonable enforcement remedy.

I. Background

Petitioner is located in Lakeland, Florida, and participates in Medicare as a skilled
nursing facility (SNF) and the state Medicaid program as a nursing facility (NF).
Petitioner was subject to three surveys by the Florida Agency for Health Care
Administration (state agency) that ended on February 27, 2012, March 30, 2012, and
May 11, 2012, respectively. Petitioner was found not in substantial compliance with
program participation requirements by each survey. Centers for Medicare & Medicaid
Services (CMS) Exhibits (Exs.) 1-3. The state agency completed a revisit survey on
August 10, 2012, and determined that Petitioner was in substantial compliance effective
that date. Petitioner’s Exhibit (P. Ex.) 7.
CMS notified Petitioner by letter dated April 19, 2012, that it was imposing the following
enforcement remedies: mandatory termination effective August 27, 2012, if Petitioner
did not return to substantial compliance before that date; a mandatory DPNA effective
May 27, 2012, if Petitioner did not return to substantial compliance before that date; and
a CMP of $150 per day effective beginning March 30, 2012 and continuing until
Petitioner returned to substantial compliance. CMS also notified Petitioner that it was
ineligible to conduct a nurse aide training and competency evaluation program
(NATCEP) for two years. P. Ex. 6. CMS notified Petitioner by letter dated July 12,
2012, that: the DPNA was effective May 27, 2012; the $150 per-day CMP was in effect
March 30 through May 10, 2012; and the CMP was increased to $250 per day effective
May 11, 2012; and these remedies would continue until Petitioner returned to substantial
compliance. Request for Hearing, Ex. 5. CMS notified Petitioner by letter dated August
21, 2012, that Petitioner returned to substantial compliance on August 10, 2012; that the
DPNA was in effect from May 27 through August 9, 2012; and that Petitioner’s provider
agreement would not be terminated. P. Ex. 7.

Petitioner requested a hearing before an administrative law judge (ALJ) on September 7,
2012. The case was assigned to Judge Richard Smith on September 20, 2012, and an
Acknowledgement and Initial Docketing Order was issued at his direction. On June 7,
2013, this case was reassigned to me for hearing and decision due to Judge Smith’s
retirement. On September 17, 2013, I convened a hearing by video teleconference from
Kansas City, with Petitioner participating from Tampa, Florida and CMS participating
from Atlanta, Georgia. A transcript (Tr.) of the proceedings was prepared. CMS offered
CMS Exs. | through 6 and Petitioner offered P. Exs. 1 through 32, all of which I admit as
evidence. Tr. 47-48, 53-54. CMS called Surveyor Barbara Doyle, RN, as a witness.
Petitioner called the following witnesses: Laurie VanderMeer, RN, and Brian McCoy.
The parties filed post-hearing briefs (CMS Br. and P. Br., respectively) and post-hearing
reply briefs (CMS Reply and P. Reply, respectively).

IL. Discussion
A. Issues

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

Whether the remedy imposed is reasonable.
B. Applicable Law

The statutory and regulatory requirements for participation of a SNF in Medicare are
found at section 1819 of the Social Security Act (Act) and at 42 C.F.R. pt. 483.' Section
1819(h)(2) of the Act authorizes the Secretary of Health and Human Services (Secretary)
to impose enforcement remedies against a SNF for failure to comply substantially with
the federal participation requirements established by sections 1819(b), (c), and (d) of the
Act.” The Act requires that the Secretary terminate the Medicare participation of any
SNF that does not return to substantial compliance with participation requirements within
six months of being found not to be in substantial compliance. Act § 1819(h)(2)(C). The
Act also requires that the Secretary deny payment of Medicare benefits for any
beneficiary admitted to a SNF, if the SNF fails to return to substantial compliance with
program participation requirements within three months of being found not to be in
substantial compliance — commonly referred to as the mandatory or statutory DPNA. Act
§ 1819(h)(2)(D). The Act grants the Secretary discretionary authority to terminate a
noncompliant SNF’s participation in Medicare, even if there has been less than 180 days
of noncompliance. The Act also grants the Secretary authority to impose other
enforcement remedies, including a discretionary DPNA, CMPs, appointment of
temporary management, and other remedies such as a directed plan of correction. Act

§ 1819(h)(2)(B).

The Secretary has delegated to CMS and the states the authority to impose remedies
against a long-term care facility that is not complying substantially with federal
participation requirements. “Substantial compliance means a level of compliance with
the requirements of participation such that any identified deficiencies pose no greater risk
to resident health or safety than the potential for causing minimal harm.” 42 C.F.R.

§ 488.301 (emphasis in original). A deficiency is a violation of a participation
requirement established by sections 1819(b), (c), and (d) of the Act or the Secretary’s
regulations at 42 C.F.R. pt. 483, subpt. B. Noncompliance refers to any deficiency that
causes a facility not to be in substantial compliance. 42 C.F.R. § 488.301. State survey
agencies survey facilities that participate in Medicare on behalf of CMS to determine

' Citations are to the 2011 revision of the Code of Federal Regulations which was in
effect at the time of the surveys, unless otherwise stated.

> Participation of a NF in Medicaid is governed by section 1919 of the Act. Section
1919(h)(2) of the Act gives enforcement authority to the states to ensure that NFs comply
with their participation requirements established by sections 1919(b), (c), and (d) of the
Act.
whether the facilities are complying with federal participation requirements. 42 C.F.R.
§§ 488.10-.28, 488.300-.335. The regulations specify the enforcement remedies that
CMS may impose if a facility is not in substantial compliance with Medicare
requirements. 42 C.F.R. § 488.406.

The regulations specify that a CMP that is imposed against a facility on a per-day basis
will fall into one of two ranges of penalties. 42 C.F.R. §§ 488.408, 488.438. The upper
range of a CMP, $3,050 per day to $10,000 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). “dmmediate jeopardy means a
situation in which the provider’s noncompliance with one or more requirements of
participation has caused, or is likely to cause, serious injury, harm, impairment, or death
to a resident.” 42 C.F.R. § 488.301 (emphasis in original). The lower range of CMPs,
$50 per day to $3,000 per day, is reserved for deficiencies that do not pose immediate
jeopardy, but either cause actual harm to residents, or cause no actual harm but have the
potential for causing more than minimal harm. 42 C.F.R. § 488.438(a)(1)(ii).

Petitioner was notified that it was ineligible to conduct a NATCEP for two years.
Pursuant to sections 1819(b)(5) and 1919(b)(5) of the Act, SNFs and NFs may only use
nurse aides who have completed a training and competency evaluation program.
Pursuant to sections 1819(f)(2) and 1919(f)(2) of the Act, the Secretary was tasked to
develop requirements for approval of NATCEPs and the process for review of those
programs. Sections 1819(e) and 1919(e) of the Act impose upon the states the
requirement to specify what NATCEPs they will approve that meet the requirements that
the Secretary established and a process for reviewing and re-approving those programs
using criteria the Secretary set. The Secretary promulgated regulations at 42 C.F.R. pt.
483, subpt. D. Pursuant to 42 C.F.R. § 483.151(b)(2) and (f), a state may not approve
and must withdraw any prior approval of a NATCEP offered by a SNF or facility NF that
has been: (1) subject to an extended or partial extended survey under sections
1819(g)(2)(B)(i) or 1919(g)(2)(B)(@) of the Act; (2) assessed a CMP of not less than
$5,000; or (3) subject to termination of its participation agreement, a DPNA, or the
appointment of temporary management. Extended and partial extended surveys are
triggered by a finding of “substandard quality of care” during a standard or abbreviated
standard survey and involve evaluating additional participation requirements.
“Substandard quality of care” is identified by the situation where surveyors identify one
or more deficiencies related to participation requirements established by 42 C.F.R.

§ 483.13 (Resident Behavior and Facility Practices), § 483.15 (Quality of Life), or

§ 483.25 (Quality of Care) that are found to constitute either immediate jeopardy, a
pattern of or widespread actual harm that does not amount to immediate jeopardy, or a
widespread potential for more than minimal harm that does not amount to immediate
jeopardy and there is no actual harm. 42 C.F.R. § 488.301.

The Act and regulations make a hearing before an ALJ available to a long-term care
facility against which CMS has determined to impose an enforcement remedy. Act

§§ 1128A(c)(2), 1866(h); 42 C.F.R. §§ 488.408(g), 498.3(b)(13). A facility has a right to
appeal a “certification of noncompliance leading to an enforcement remedy.” 42 C.F.R.
§§ 488.408(g)(1); 488.330(e), 498.3. 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 NATCEP.
42 C.F.R. § 498.3(b)(14), (d)(10)(i). The CMS determination as to the level of
noncompliance, including the finding of immediate jeopardy, “must be upheld unless it is
clearly erroneous.” 42 C.F.R. § 498.60(c)(2); Woodstock Care Ctr., DAB No. 1726 at 9,
38 (2000), aff'd, 363 F.3d 583 (6th Cir. 2003). The Departmental Appeals Board (the
Board) has long held that the net effect of the regulations is that a provider has no right to
challenge the scope and severity level assigned to a noncompliance finding, except in the
situation where that finding was the basis for an immediate jeopardy determination. See,
e.g., Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750 (2000).
ALJ review of a CMP is subject to 42 C.F.R. § 488.438(e).

The hearing before an ALJ is a de novo proceeding, that is, “a fresh look by a neutral
decision-maker at the legal and factual basis for the deficiency findings underlying the
remedies.” Life Care Ctr. of Bardstown, DAB No. 2479 at 32 (2012) (citation omitted).
The Board has long held that the petitioner bears the burden of persuasion to show by a
preponderance of the evidence that it was in substantial compliance with participation
requirements or any affirmative defense. Batavia Nursing & Convalescent Inn, DAB No.
1911 (2004); Batavia Nursing & Convalescent Ctr., DAB No. 1904, 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, aff'd, Hillman Rehab. Ctr. v. United States, No. 98-
3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999). However, only when CMS
makes a prima facie showing of noncompliance, is the facility burdened to show, by a
preponderance of the evidence on the record as a whole, that it was in substantial
compliance or had an affirmative defense. Evergreene Nursing Care Ctr., DAB No.
2069 at 4.

The standard of proof, or quantum of evidence required, is a preponderance of the
evidence. CMS has the burden of coming forward with the evidence and making a prima
facie showing of a basis for imposing an enforcement remedy. The Board has stated that
CMS must come forward with “evidence related to disputed findings that is sufficient
(together with any undisputed findings and relevant legal authority) to establish a prima
facie case of noncompliance with a regulatory requirement.” Evergreene Nursing Care
Ctr., DAB No. 2069 at 7 (2007); 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). In Hillman Rehab. Ctr., the Board described the elements of the CMS prima facie
case in general terms as follows:

HCFA [now known as CMS] must identify the legal criteria
to which it seeks to hold a provider. Moreover, to the extent
that a provider challenges HCFA’s findings, HCFA must
come forward with evidence of the basis for its determination,
including the factual findings on which HCFA is relying and,
if HCFA has determined that a condition of participation was
not met, HCFA’s evaluation that the deficiencies found meet
the regulatory standard for a condition-level deficiency.

DAB No. 1611 at 8. Thus, CMS has the initial burden of coming forward with sufficient
evidence to show that its decision to impose an enforcement remedy is legally sufficient
under the statute and regulations. To make a prima facie case that its decision was
legally sufficient, CMS must: (1) identify the statute, regulation or other legal criteria to
which it seeks to hold the provider; (2) come forward with evidence upon which it relies
for its factual conclusions that are disputed by Petitioner; and (3) show how the
deficiencies it found amount to noncompliance that warrants an enforcement remedy, that
is, that there was a risk for more than minimal harm due to the regulatory violation. In
Evergreene Nursing Care Ctr., the Board explained its “well-established framework for
allocating the burden of proof on the issue of whether a SNF is out of substantial
compliance” as follows:

CMS has the burden of coming 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. If CMS makes this prima facie showing, then
the SNF must carry its ultimate burden of persuasion by
showing, by a preponderance of the evidence, on the record
as a whole, that it was in substantial compliance during the
relevant period.

DAB No. 2069 at 7. CMS makes a prima facie showing of noncompliance if the credible
evidence CMS relies on is sufficient to support a decision in its favor absent an effective
rebuttal. The regulation gives Petitioner notice of the criteria or elements it must meet to
comply with the program participation requirement established by the regulation.

5 U.S.C. §§ 551(4), 552(a)(1). Therefore, in order to make a prima facie showing of
noncompliance, CMS must show that Petitioner violated the regulation by not complying
with one or more of the criteria or elements of the regulation, which is a

deficiency. CMS must also show that the deficiency amounted to “noncompliance,” that
is, that Petitioner was not in substantial compliance because the deficiency posed a risk
for more than minimal harm. See Jennifer Matthew Nursing & Rehab. Ctr., DAB No.
2192 at 20 n.12 (2008). A facility can overcome CMS’s prima facie case either by
rebutting the evidence upon which that case rests, or by proving facts that affirmatively
show substantial compliance. “An effective rebuttal of CMS’s prima facie case would
mean that at the close of the evidence the provider had shown that the facts on which its
case depended (that is, for which it had the burden of proof) were supported by a
preponderance of the evidence.” Jd. at 7-8 (citations omitted).

C. Findings of Fact, Conclusions of Law, and Analysis

My conclusions of law are set forth in bold text followed by my findings of fact and
analysis. I have carefully considered all the evidence and the arguments of both parties,
though not all may be specifically discussed in this decision. I discuss in this decision the
credible evidence given the greatest weight in my decision-making.* 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).

There are three surveys at issue in this case.

e February 27, 2012 Survey. A complaint investigation was completed on
February 27, 2012. The surveyors concluded that Petitioner was not in substantial
compliance due to violations of 42 C.F.R. §§ 483.15(h)(1) (Tag F252‘ ata scope

> “Credible evidence’ is evidence that is worthy of belief. Black’s Law Dictionary 596
(8" ed. 2004). The “weight of evidence” is the persuasiveness of some evidence
compared to other evidence. Id. at 1625.

* This is a “Tag” designation as used in CMS Publication 100-07, State Operations
Manual (SOM), app. PP, titled Guidance to Surveyors for Long Term Care Facilities
(http://www.cms.hhs.gov/Manuals/IOM/list.asp). The “Tag” refers to the specific
regulatory provision allegedly violated and CMS’s policy guidance to surveyors.
Although the SOM does not have the force and effect of law, the provisions of the Act
and regulations interpreted clearly do have such force and effect. Ind. Depart. of Pub.
Welfare v. Sullivan, 934 F.2d 853 (7th Cir. 1991); Northwest Tissue Ctr. v. Shalala, |
(Footnote continued next page.)

and severity (s/s) of D°), 483.15(h)(2) (Tag F253, s/s E), and 483.75(/)(1) (Tag
F514, s/s D). CMS Ex. 1. CMS stipulated at hearing that the surveyors concluded
on March 30, 2012, that all three deficiencies were corrected as of March 27,
2012. Tr. 18-19; P. Ex. 3.

e March 30, 2012 Survey. A second complaint investigation was completed on
March 30, 2012. The surveyors concluded that Petitioner was not in substantial
compliance due to violations of 42 C.F.R. §§ 483.10(b)(11) (Tag F157, s/s D) and
483.35(c) (Tag F363, s/s E). CMS Ex. 2. CMS stipulated at hearing that the
surveyors concluded on May 11, 2012, that both deficiencies were corrected as of
April 13, 2012. Tr. 19-20; P. Ex. 4.

e May 11, 2012 Survey. A combined annual, life safety, complaint, and revisit
survey was conducted from May 8 through 11, 2012. The surveyors concluded
that Petitioner was not in substantial compliance due to the following 13
regulatory violations: 42 C.F.R. §§ 483.10(b)(1) and (5)-(10) (Tag F156, s/s D),
483.10(c)(2)-(5) (Tag F159, s/s D), 483.15(e)(1) (Tag F246, s/s D), 483.15(h)(2)
(Tag F253, s/s E), 483.15(h)(6) (Tag F257, s/s D), 483.20(k)(3)(ii) (Tag F282, s/s
D), 483.25(h) (Tag F323, s/s D), 483.25(n) (Tag F334, s/s D), 483.35(i) (Tag

(Footnote continued.)

F.3d 522 (7th Cir. 1993). Thus, while the Secretary may not seek to enforce the
provisions of the SOM, she may seek to enforce the provisions of the Act or regulations
as interpreted by the SOM.

> Scope and severity levels are used by CMS and a state when selecting remedies. The
scope and severity level is designated by an alpha character, A through L, selected by
CMS or the state agency from the scope and severity matrix published in the SOM, Chap.
7, § TAO0E. A scope and severity level of A, B, or C indicates a deficiency that presents
no actual harm but has the potential for minimal harm, which is an insufficient basis for
imposing an enforcement remedy. Facilities with deficiencies of a level no greater than
C remain in substantial compliance. 42 C.F.R. § 488.301. A scope and severity level of
D, E, or F indicates a deficiency that presents no actual harm but has the potential for
more than minimal harm that does not amount to immediate jeopardy. A scope and
severity level of G, H, or I indicates a deficiency that involves actual harm that does not
amount to immediate jeopardy. Scope and severity levels J, K, and L are deficiencies
that constitute immediate jeopardy to resident health or safety. The matrix, which is
based on 42 C.F.R. § 488.408, specifies which remedies are required and optional at each
level based upon the frequency of the deficiency.
F371, s/s D), 483.60(a), (b) (Tag F425, s/s D), 483.60(b), (d), and (e) (Tag F431,
s/s D), 483.65 (Tag F441, s/s D), and 483.70(g) (Tag F464, s/s D).

CMS alleges that the three surveys establish that Petitioner was continually not in
substantial compliance with program participation requirements from February 27
through August 9, 2012; that the mandatory DPNA was triggered; and that there was a
basis for the imposition of the CMP.

Petitioner argues that there were periods of substantial compliance between the surveys
and that it returned to substantial compliance not later than June 10, 2012. Petitioner
does not dispute many of the deficiency citations or that for brief periods it was not in
substantial compliance. Petitioner disputes the onset dates of the noncompliance alleged
under Tag F157 of the March survey and Tag F334 of the May survey. Tr. 21-22; P. Br.
at 5. Petitioner also disputes that the mandatory DPNA was triggered and that the
duration of the CMP was reasonable. Tr. 24-25.

The allegations for the surveys are discussed sequentially to facilitate the analysis.

1. Petitioner violated 42 C.F.R. § 483.15(h)(1)(Tag F252, s/s D) from
February 27 to March 27, 2012.

2. Petitioner violated 42 C.F.R. § 483.15(h)(2) (Tag F253, s/s E), from
February 27 to March 27, 2012.

3. Petitioner violated 42 C.F.R. § 483.75()(1) (Tag F514, s/s D) from
February 27 to March 27, 2012.

4. Petitioner was not in substantial compliance with program
participation requirements during the period February 27, 2012
through March 26, 2012, due to violations of 42 C.F.R.

§§ 483.15(h)(1)(Tag F252), 483.15(h)(2) (Tag F253), and 483.75(J)(1)
(Tag F514) that posed a risk for more than minimal harm to
Petitioner’s residents.

The Statement of Deficiencies (SOD) for the survey that concluded on February 27,
2012, alleges that Petitioner was not in substantial compliance with program participation
requirements due to violations of 42 C.F.R. §§ 483.15(h)(1)(Tag F252, s/s of D),
483.15(h)(2) (Tag F253, s/s E), and 483.75(/)(1) (Tag F514, s/s D). CMS Ex. 1; P. Ex. 1.
It is not alleged in the SOD or by CMS that the period of noncompliance began prior to
the end of the survey on February 27, 2012. Tag F252 was based on the surveyor’s
observation on February 27, 2012, that a resident needed a new mattress and a new
mattress was provided that day. CMS Ex. | at 1-3; P. Ex. 1 at 1-3. Tag F253 was based
on the surveyor’s observation on February 27, 2012, that there was “black bio-growth” in
10

some resident bathrooms; chipped and missing paint in some rooms; a broken air
conditioner in one room; a missing handle on a dresser; a detached base board; broken
and replacement furniture sitting in a hallway. CMS Ex. | at 3-5; P. Ex. | at 3-5. Tag
F514 was based on errs in medication administration records for two residents that the
surveyor identified on February 27, 2012. CMS Ex. 1 at 5-7; P. Ex. | at 5-7.

Petitioner does not dispute the violations alleged or that it was not in substantial
compliance beginning February 27, 2012. CMS stipulated at hearing that the surveyors
concluded on March 30, 2012, that all three deficiencies cited by this survey were
corrected as of March 27, 2012. Tr. 18-19; P. Ex. 3. CMS did not stipulate that
Petitioner returned to substantial compliance as of March 27, 2012. Whether or not
Petitioner returned to substantial compliance is discussed in the context of the March
survey.

The scope and severity of the cited deficiencies are not subject to my review because a
successful challenge would not affect the range of the CMP that may be imposed or
impact the facility’s authority to conduct a NATCEP. 42 C.F.R. § 498.3(b)(14),
(d)(10)(i).

Accordingly, I conclude that Petitioner was not in substantial compliance with program
participation requirements during the period February 27, 2012 through March 26, 2012,
due to violations of 42 C.F.R. §§ 483.15(h)(1)(Tag F252), 483.15(h)(2) (Tag F253), and
483.75(/)(1) (Tag F514) that posed a risk for more than minimal harm to Petitioner’s
residents.

5. Petitioner violated 42 C.F.R. § 483.10(b)(11) (Tag F157, s/s D) from
March 23, 2012 to April 13, 2012.

6. Petitioner violated 42 C.F.R. § 483.35(c) (Tag F363, s/s E) from
March 30, 2012 to April 13, 2012.

7. Petitioner was not in substantial compliance with program
participation requirements during the period March 23, 2012 through
April 13, 2012, due to violations of 42 C.F.R. §§ 483.10(b)(11) (Tag
F157, s/s D) and 483.35(c) (Tag F363, s/s E) that posed a risk for more
than minimal harm to Petitioner’s residents.

The SOD for the survey that concluded on March 30, 2012, alleges that Petitioner was
not in substantial compliance with program participation requirements due to violations
of 42 C.F.R. §§ 483.10(b)(1 1) (Tag F157) and 483.35(c) (Tag F363). CMS Ex. 2; P.
Ex.2. Tag F363 is discussed first as there is no dispute regarding that deficiency.
11

The surveyors allege under Tag F363 that on March 29 and 30, 2012, surveyors received
complaints about the facility food. During lunch on March 30, a surveyor observed that
some portions served were smaller than the menu required. CMS Ex. 2 at 8-10; P. Ex. 2
at 8-10. Petitioner does not dispute the deficiency citation and CMS stipulated that the
deficiency was corrected on April 13, 2012. The surveyors cited this deficiency at a
scope and severity of D, which is not subject to my review because a successful challenge
would not affect the range of the CMP that may be imposed or impact the facility’s
authority to conduct a NATCEP. 42 C.F.R. § 498.3(b)(14), (d)(10)(i). Accordingly, I
conclude that the deficiency cited under Tag F363 posed a risk for more than minimal
harm and amounted to noncompliance. The deficiency continued from March 30 to April
13, 2012, when the deficiency was corrected as stipulated by CMS.

Petitioner does dispute the deficiency cited under Tag F157, which alleges that Petitioner
violated 42 C.F.R. § 483.10(b)(11) because staff failed to immediately consult with
Resident 2’s physician and notify her family when Resident 2 fell on March 23, 2012.
CMS Ex. 2 at 1-7; P. Ex. 2 at 1-7. The surveyors also alleged a deficiency under Tag
F157 based on Petitioner’s failure to consult the physician and report to the family when
Resident 4 fell on March 29, 2012. CMS Ex. 2 at 7-10; P. Ex. 2 at 7-10. If the allegation
that the deficiency related to Resident 2 began on March 23, 2012 is meritorious, that
determination would compel the conclusions that: Petitioner did not return to substantial
compliance on March 27, 2012, the date on which CMS agrees the deficiencies from the
February survey were corrected; and Petitioner continued not to be in substantial
compliance with program participation requirements from February 27 through at least
April 13, 2012, due to the deficiency under Tag F157 identified by the March 30, 2012
survey. It is not necessary to examine the example of Resident 4 as the allegations
related to Resident 2 have merit.

a. Facts Related to Resident 2’s Fall on March 23, 2012

The surveyors allege in the SOD that nurse’s notes show that at about 1:20 a.m. on March
23, 2012, Resident 2 was on the floor lying on her left-side. The notes show that
Resident 2 denied hitting her head; her right-side range of motion was good but she had
contractures on her left-side due to a prior stroke; she denied any pain; and no injury was
noted. Resident 2’s bedside commode was on its side, there was urine on the floor, and
the resident stated that she had used the commode and when she leaned forward to wipe
she fell. CMS Ex. 2 at 3; P. Ex. 2 at 3. At about 1:50 a.m. on March 23, 2012, 30
minutes after her fall, Resident 2 complained of left-leg pain and was given Percocet®
for which she had an order to be administered as needed prior to the fall. Resident 2 was
given another dose of Percocet® at 6:00 a.m. on March 23, 2012, four hours and 30
minutes after the fall. At 6:20 a.m. on March 23, 2012, Resident 2’s physician was
paged. The family was notified at 6:30 a.m. on March 23. Physician telephone orders
were received at 6:45 a.m. for x-rays of the left femur and pelvis due to the resident’s
complaints of pain. The x-rays revealed that Resident 2 had a fracture of the left femoral
12

neck, that is, a hip fracture. CMS Ex. 2 at 4. Petitioner introduced as evidence a copy of
the nursing progress notes and the physician progress notes related to the March 23 fall.
P. Ex. 17 at 4-5. The notes from Petitioner’s records are consistent with the allegations
of the SOD, except the notes do not reflect the administration of Percocet® or the x-ray
results, but those facts are not specifically denied by Petitioner.

b. Analysis
The regulation at issue requires:

(11) Notification of changes. (i) A facility must immediately
inform the resident; consult with the resident’s physician; and
if known, notify the resident’s legal respresentative (sic) or an
interested family member when there is —

(A) An accident involving the resident which results in
injury and has the potential for requiring physician
intervention;

(B) A significant change in the resident's physical, mental,
or psychosocial status (i.e., a deterioration in health,
mental, or psychosocial status in either life-threatening
conditions or clinical complications);

(C) A need to alter treatment significantly (i.e., a need to
discontinue an existing form of treatment due to adverse
consequences, or to commence a new form of treatment);
or

(D) A decision to transfer or discharge the resident from
the facility as specified in § 483.12(a).

42 C.F.R. § 483.10(b)(11)(i) (emphasis added). Residents in long-term care facilities
have the rights enumerated in 42 C.F.R. § 483.10. Among the rights listed are the right to
notice of rights and services, including the right to have the facility give immediate notice
of significant changes in the resident’s condition to the resident, the resident’s physician,
and the resident’s legal representative or interested family member. The language of the
regulation is very specific that the facility “must immediately inform the resident;
consult with the resident’s physician; and . . . notify the resident’s legal representative or
an interested family member” whenever any of the specified circumstances occur.

42 C.F.R. § 483.10(b)(11)(emphasis added). The regulation distinguishes between
informing the resident and family and the requirement to consult the resident’s physician.
The regulatory language is clear that the requirement to consult is not discretionary and
requires more than merely informing or notifying the physician. The regulatory history
for the regulation shows that the drafters’ intended that the facility should “inform” the
resident of the changes that have occurred but should “consult with the physician about
13

actions that are needed.” 56 Fed. Reg. 48,826, 48,833 (Sept. 26, 1991). The plain
language of the regulation and the regulatory history support the conclusion that
regulatory requirement to consult with the physician requires more than simply notifying
the physician. Consultation requires a dialogue with and a responsive directive from the
resident’s physician as to what actions are needed; it is not enough to merely notify the
physician. Nor is it enough to leave a message for the physician. The regulation also
requires notification and consultation “immediately” upon discernment of a significant
change in condition of the resident or the occurrence of an accident that may require
physician intervention, or the occurrence of any of the other triggers in the regulation.
The use of the term “immediately” in the regulation indicates that consultation is
expected to be done as soon as the change is detected, without any intervening interval of
time. It does not mean that the facility can wait hours or days before notification of the
resident and his or her representative and consultation with the physician. The regulatory
history shows that an early draft of the rule granted the facility up to 24 hours to consult
with the resident’s physician and to notify the legal representative or family. However,
after the receipt of comments emphasizing that time is of the essence in such
circumstances, the final rule eliminated the 24-hour period for notification and imposed
the requirement that the physician be consulted and the legal representative or family be
notified immediately. 56 Fed. Reg. 48,826, 48,833 (Sept. 26, 1991). The Board has been
consistent in its interpretation of the regulation that consultation with a physician must
occur immediately, that is, without delay, after a significant change is detected or
observed. Magnolia Estates Skilled Care, DAB No. 2228 at 9 (2009).

Furthermore, if we balance the relative inconvenience to a physician and the facility staff
to consult with the possibility for dire consequences to the resident if the physician is not
immediately consulted, any inconvenience certainly is inconsequential and outweighed
by the potential for significant harm to the resident if the facility fails to immediately
consult the physician. The regulation at 42 C.F.R. § 483.10 is titled “Resident rights” and
the requirements of this specific regulation provide that every resident has the right,
among other things, to a dignified existence and access to and communication with
persons and services inside and outside the facility. Therefore, the regulatory
requirements make inconsequential any inconvenience under the regulation to the
resident’s physician or to the facility staff when compared to the protection and
facilitation of the rights of the resident. 56 Fed. Reg. at 48,834. Finally, the regulation
does not allow the facility to pick and choose whom to notify and whom to consult.
Rather, it requires that the facility immediately inform the resident, consult the physician
and notify the resident’s legal representative or interested family member. The regulation
also requires that the facility consult and notify and does not permit a facility to rely upon
a notification or consultation being accomplished by the resident or a third-party such as
an emergency room.

In this case Resident 2 fell from the bed-side commode on March 23, 2012 at about 1:20
a.m. There is no question that her fall was an accident within the meaning of 42 C.F.R.
14

§ 483.10(b)(11)(@)(A). It was not apparent at 1:20 a.m., when Resident 2 was found, that
she suffered an injury. However, at 1:50 a.m., only 30 minutes after the fall she began
complaining of left-leg pain. Therefore, at 1:50 a.m., it was certainly evident that the
accident potentially caused an injury that would require physician intervention.

However, Petitioner’s staff failed to immediately consult with Resident 2’s physician at
1:50 a.m. as required by the regulation. The fact that it was very early in the morning and
that a call might disturb the physician is not a defense to the regulatory requirement to
consult. Accordingly, I conclude that there was a prima facie showing that Petitioner
violated 42 C.F.R. § 483.10(b)(11) on March 23, 2012. Resident 2 suffered pain from the
hip fracture, which is actual harm even though the severity cited by the surveyors was no
actual harm but a risk for more than minimal harm but not immediate jeopardy. The
scope and severity of the deficiency is not subject to review. 42 C.F.R. § 498.3(b)(14),

(d)(10)(i).

I conclude that Petitioner failed to rebut the prima facie showing or establish an
affirmative defense. Petitioner urges me to rule that CMS cannot allege that the
noncompliance cited by the March 30, 2012 survey under Tag F157 began earlier than
March 30, 2012. Petitioner cites no authority that imposes such a limitation. Petitioner
also argues that CMS raised the theory that a deficiency occurred prior to the March 30,
2012 for the first time in its prehearing brief. Petitioner’s Prehearing Brief (P. Ph. Br.) at
12-13. However, the SOD for the March 30, 2012 survey clearly alleges that the
deficiency cited under Tag F157 related to Resident 2 arose on March 23, 2012, when the
resident fell and complained of pain and staff failed to immediately consult the physician.
CMS Ex. 2 at 2, 4; P. Ex. 2, 4.

Petitioner argues that the allegations under Tag F157 related to Resident 2 do not state a
violation of 42 C.F.R. § 483.10(b)(11). P. Ph. Br. at 13-14. Petitioner does not dispute
that Resident 2 fell and that there was no consultation with the physician until four and
one-half hours after the accident. However, Petitioner asserts that the resident
complained of “left sided pain, which she had regularly.” P. Ph. Br. at 13-14. Petitioner
mischaracterizes the facts in evidence. The SOD specifically states that the complaint
was “pain in the left leg” not generalized left sided pain. CMS Ex. 2 at 4; P. Ex. 2 at 4.
Petitioner implies, without specifically arguing, that staff may have been unable to
determine that the resident’s complaints of pain were due to an injury secondary to the
fall. P. Reply at 3-4. Petitioner presented no evidence that Resident 2 had regular
complaints of pain associated with her left leg. Although I am willing to infer that she
ad a standing order for pain medication for some reason, I cannot infer that it was for
left-leg pain. Furthermore the fact that staff may have not been clear that the complaints
of pain were associated with the fall is simply no defense in this case. Resident 2 fell and
she complained of pain within 30 minutes of the fall. Therefore, consultation with the
physician was required to permit the physician to diagnose and decide how to intervene
considering the known facts. Consultation did occur several hours later. However,
Petitioner does not argue or point to any authority to support a conclusion that the

15

consultation with the physician several hours after the accident and the first complaint of
pain met the regulatory requirement that the consultation occur immediately. Petitioner
also argues that there was no potential for more than minimal harm and CMS failed to
make a prima facie showing for that reason. P. Pr. Br. at 14. Petitioner does not dispute
or rebut the evidence that Resident 2 made two complaints of left-leg pain the morning of
March 23, 2012, prior to the consultation with her physician. I conclude, without
hesitation, that pain secondary to a hip fracture is actual harm and more than adequate to
satisfy the requirement for CMS to show as part of its prima facie case that there was a
risk for more than minimal harm.

Contrary to Petitioner’s arguments, I conclude that Petitioner was not in substantial
compliance between March 23 and 30, 2012. Accordingly, I conclude that Petitioner
continued not to be in substantial compliance with program participation requirements
from February 27, 2012 through at least April 13, 2012.

8. Petitioner violated 42 C.F.R. § 483.10(b)(1) and (5)-(10) (Tag F156,
s/s D) from March 30, 2012 through June 10, 2012.

9. Petitioner violated 42 C.F.R. § 483.10(c)(2)-(5) (Tag F159, s/s D)
from May 3, 2012 through June 10, 2012.

10. Petitioner violated 42 C.F.R. § 483.15(e)(1) (Tag F246, s/s D) from
May 10, 2012 through June 10, 2012.

11. Petitioner violated 42 C.F.R. § 483.15(h)(2) (Tag F253, s/s E) from
May 10, 2012 through June 10, 2012.

12. Petitioner violated 42 C.F.R. § 483.15(h)(6) (Tag F257, s/s D) from
May 8, 2012 through June 10, 2012.

13. Petitioner violated 42 C.F.R. § 483.20(k)(3)(ii) (Tag F282, s/s D)
from May 6, 2012 through June 10, 2012.

14. Petitioner violated 42 C.F.R. § 483.25(h) (Tag F323, s/s D) from
May 9, 2012 through June 10, 2012.

15. Petitioner violated 42 C.F.R. § 483.25(n)(2) (Tag F334, s/s D) from
February 27, 2012 through June 10, 2012.

16. Petitioner violated 42 C.F.R. § 483.35(i) (Tag F371, s/s D) from
May 8, 2012 through June 10, 2012.
16

17. Petitioner violated 42 C.F.R. § 483.60(a), (b) (Tag F425, s/s D) from
May 2, 2012 through June 10, 2012.

18. Petitioner violated 42 C.F.R. § 483.60(b), (d), and (e) (Tag F431, s/s
D) from May 8, 2012 through June 10, 2012.

19. Petitioner violated 42 C.F.R. § 483.65 (Tag F441, s/s D) from May
8, 2012 through June 10, 2012.

20. Petitioner violated 42 C.F.R. § 483.70(g) (Tag F464, s/s D) from
May 8, 2012 through June 10, 2012.

21. Petitioner was not in substantial compliance from program
participation requirements from February 27 through June 10, 2012
and there is a basis for the imposition of enforcement remedies.

The combined annual, life safety, complaint, and revisit surveys conducted from May 8
through 11, 2012, concluded that Petitioner was not in substantial compliance due to the
following 13 regulatory violations: 42 C.F.R. §§ 483.10(b)(1) and (5)-(10) (Tag F156,
s/s D), 483.10(c)(2)-(5) (Tag F159, s/s D), 483.15(e)(1) (Tag F246, s/s D), 483.15(h)(2)
(Tag F253, s/s E), 483.15(h)(6) (Tag F257, s/s D), 483.20(k)(3)(ii) (Tag F282, s/s D),
483.25(h) (Tag F323, s/s D), 483.25(n) (Tag F334, s/s D), 483.35(i) (Tag F371, s/s D),
483.60(a), (b) (Tag F425, s/s D), 483.60(b), (d), and (e) (Tag F431, s/s D), 483.65 (Tag
F441, s/s D), and 483.70(g) (Tag F464, s/s D). CMS Ex. 4; P. Ex. 4. Except for the
deficiency cited under Tag F334, Petitioner does not dispute that these deficiencies were
properly cited by the surveys that ended on May 11, 2012, and I so conclude. P. Br. at
17-18. The dates that noncompliance began for each deficiency listed in Conclusion of
Law 8 through 14 and 16 through 20 are the dates listed in the SOD, as those dates have
not been disputed by Petitioner. Petitioner does dispute the date of correction for all the
cited deficiencies arguing that Petitioner corrected the deficiencies and returned to
substantial compliance on June 10, 2012 rather than August 10, 2012, as alleged by CMS.

Two deficiency citations require specific discussion, Tag F156 and Tag F334.
a. 42 C.F.R. § 483.10(b)(1) and (5)-(10) (Tag F156, s/s D)

The deficiency under Tag F156 is an alleged violation of 42 C.F.R. § 483.10(b)(1) and
(5)-(10), which establish certain resident rights. Pursuant to 42 C.F.R. § 483.10(b)(5) and
(6), a facility must inform residents of services available from the facility and which
services are the responsibility of the resident to pay and which are covered. The SOD
cites three separate findings under this deficiency. Finding 1 which has not been
contested by Petitioner states:
17

1. Record review for resident #121 revealed that a Notice of
Medicare Provider Non-Coverage form CMS — 1023 was
initiated on 3/30/12 for a last day of coverage identified as
3/30/12. The facility failed to include which skilled services
would not be covered and the amount that the resident would
be responsible for after the date of non-coverage.

CMS Ex. 3 at 4; P. Ex. 4.° The uncontested finding in the SOD establishes the violation
of 42 C.F.R. § 483.10(b)(1). The surveyors determined that the deficiency posed a risk
for more than minimal harm which is not contested by Petitioner and is not subject to my
review anyway. Finding 1 establishes noncompliance with this requirement of
participation as of March 30, 2012. There is no evidence that this deficiency was
corrected prior to the May 2012 survey. Petitioner states in its plan of correction that the
deficiency was corrected on June 10, 2012. P. Ex. 5 at 1. Therefore, contrary to
Petitioner’s arguments, this deficiency shows that Petitioner did not return to substantial
compliance between April 13, 2012 and the May 2012 survey.

b. 42 C.F.R. § 483.25(n)(2) (Tag F334, s/s D)

Petitioner focused on Tag F334 from the May 11, 2012 survey arguing that the survey did
not establish noncompliance after April 13, 2012 (when CMS stipulated the deficiencies
cited in the March 2012 survey were corrected) and before the May 2012 survey. Tag
F334 alleges a violation of 42 C.F.R. § 483.25(n). The regulation requires:

(n) Influenza and pneumococcal immunizations—

2 OR

(2) Pneumococcal disease. The facility must develop policies
and procedures that ensure that—

(i) Before offering the pneumococcal immunization, each
resident or the resident’s legal representative receives
education regarding the benefits and potential side effects
of the immunization;

° The form number cited in the SOD is incorrect. The form referred to is likely a CMS
10123, Expedited Review Notice-Notice of Medicare Provider Non-coverage.
18

(ii) Each resident is offered a pneumococcal
immunization, unless the immunization is medically
contraindicated or the resident has already been
immunized;

(iii) The resident or the resident’s legal representative has
the opportunity to refuse immunization; and

(iv) The resident’s medical record includes documentation
that indicates, at a minimum, the following:

(A) That the resident or resident’s legal representative
was provided education regarding the benefits and
potential side effects of pneumococcal immunization;
and

(B) That the resident either received the pneumococcal
immunization or did not receive the pneumococcal
immunization due to medical contraindication or
refusal.

(v) Exception. As an alternative, based on an assessment
and practitioner recommendation, a second pneumococcal
immunization may be given after 5 years following the
first pneumococcal immunization, unless medically
contraindicated or the resident or the resident’s legal
representative refuses the second immunization.

42 C.F.R. § 483.25(n)(2).’ The regulation does not require that every resident receive

the

pneumococcal immunization. The regulation does require that Petitioner ensure,

through the adoption of policies and procedures,* that:

T

ere is no alleged violation of 42 C.F.R. § 483.25(n)(1) which imposes requirements

related to influenza immunizations.

ST

e purpose of the regulation is broader than simply requiring Petitioner to create a

document and implement a policy and procedure. The regulatory history shows that the

dra:

ters intended to require that a facility “offer (without a specified timeframe) lifetime

immunization against pneumococcal disease” with a second immunization when
necessary. 70 Fed. Reg. 58,834, 58,839-46 (Oct. 7, 2005). The drafters also intended to
(Footnote continued next page.)
19

e Every resident or the resident’s legal representative is educated about the
risks and benefits of the immunization;

e Every resident is offered the pneumococcal immunization, unless medically
contraindicated or the resident was previously immunized;

e Every resident or the resident’s legal resident must be given the right to
refuse the immunization; and

e The resident’s medical record must contain documentation of the education
and administration of the immunization, or that the immunization was not
administered because it was medically contraindicated or the resident or
legal representative refused.

The regulation suggests, but does not require, that the pneumococcal immunization may
be offered again five years after the first pneumococcal immunization is given. 42 C.F.R.
§ 483.25(n)(2)(v); Tr. 100. The regulation does not state if or when education and the
immunization should be reoffered after an initial refusal. Tr. 105-06.

It is alleged in the SOD that Petitioner violated the regulation in the case of Residents 9
and 81. The allegation regarding Resident 9 is that the surveyor found in Resident 9’s
clinical record a form dated in December 2009 showing that she declined a
pneumococcal immunization but no subsequent documentation that she received or
declined the immunization. CMS Ex. 3 at 18; P. Ex. 5 at 18. The SOD does not allege
that the clinical record fails to show education as required by 42 C.F.R.

§ 483.25(n)(2)(iv). The regulation does not establish a requirement for when a resident
must be reoffered the vaccine; re-educated; and given the opportunity to accept or decline
the vaccine. Surveyor Doyle testified in response to my question that there was no
requirement for Petitioner to educate and re-offer the immunization to Resident 9
between December 2009 and the May 2012 survey. Tr. 105-06. In the case of Resident
9, the form completed in December 2009 satisfies the requirement of the regulation and
the SOD fails to state a regulatory violation based on the example of Resident 9.

In the example of Resident 81, it is alleged that Resident 81 was admitted to the facility
on August 5, 2011 but the surveyor could find no documentation in the clinical record

(Footnote continued.)

require that compliance with the regulatory requirement be documented in each resident’s
medical record.
20

that the resident was offered and either received or declined the vaccine. CMS Ex. 3 at
19; P. Ex. 5 at 19. Petitioner argues that the regulation does not establish a time by which
a new resident must be offered the pneumococcal vaccine. P. Br. at 19-20. Petitioner is
correct that the regulation specifies no deadline by which a resident must be educated and
offered the immunization or that the resident’s records must contain the required
documentation. However, 42 C.F.R. § 483.25(n)(2)(iv) clearly states that at a minimum a
resident’s medical record must include evidence of education regarding the benefits and
possible side-effects of the vaccine and evidence that the vaccine was either received,
rejected, or could not administered due to medical contraindication. The regulation
requires that the documentation be present in the medical records for all residents, I see
no other interpretation. Although Petitioner might defend the absence of the required
documents on grounds that a resident was recently admitted, Resident 81 was not recently
admitted to Petitioner. Petitioner offers no evidence to rebut the surveyor’s observation
recorded in the SOD that there was no documentation in the medical record of Resident
81. Petitioner offers no evidence to explain the absence of the required documentation
that might be considered a defense.

Petitioner argues that the violation related to Resident 81 does not rise to the level of
noncompliance as there is no risk for more than minimal harm. P. Br. at 20; P. Reply at
6, 8-9. The surveyors cited the deficiency under Tag F334 at a severity of D, meaning
that there was no actual harm or immediate jeopardy but a risk for more than minimal
harm. CMS Ex. 3 at 16. The SOD does not specifically articulate the basis for the
severity determination. However, I accept that the severity citation by the surveyors is
some evidence that there was a risk for more than minimal harm. Surveyor Doyle also
opined that there was a risk for more than minimal harm related to failure to ensure all
residents were offered the vaccine. Tr. 70-71. CMS has also issued policy found in the
SOM, app. PP, Tag F334, which discusses the purposes for the regulation including the
reduction of the risk of transmission of influenza and pneumonia among nursing home
residents who live in a closed setting and are at higher risk for infection and adverse
results than the general population.

I conclude that the evidence offered by CMS is sufficient to meet its burden of making a
prima facie showing that there is a risk for more than minimal harm due to violation of
the regulatory requirement. Thus, it was incumbent upon Petitioner to present some
evidence to show that there was no risk for more than minimal harm. Petitioner failed to
satisfy its burden. Petitioner argues that there was no risk for more than minimal harm
because Residents 9 and 81 represent less than two percent of the facility population and
it was likely they would have declined the vaccine earlier if offered. P. Br. at 20.
Petitioner was not cited, however, because Residents 9 and 81 did not take the vaccine.
Resident 9 and 81 could not be compelled to take the vaccine. Petitioner was cited and I
sustain the deficiency as to Resident 81, because there was no documentation that
Resident 81 or her legal representative was educated on the benefits and risks of the
vaccine and given the choice whether or not to take the vaccination. Residents have the

21

right to decline the vaccine but they should do so after being educated. Further,
increasing the number residents educated and vaccinated theoretically reduces the risk for
infection among the facility population.

In this case, Petitioner’s policy and procedure failed to ensure that Resident 81 received
the required education and that she was given the choice to be vaccinated or not.
Petitioner argues that the regulation requires that Petitioner have policies and procedures,
but CMS did not allege that Petitioner’s policies and procedures were inadequate.
Petitioner correctly points out that Petitioner’s policy is not in evidence. P. Reply at 5.
Neither CMS nor Petitioner offered Petitioner’s influenza and pneumonia immunization
policy as evidence. However, the deficiency was not cited because Petitioner failed to
ave the required policy or that the policy was defective in some regard. Rather, the
deficiency was cited because Resident 81 did not have the required paperwork in her
record and there was no evidence that Resident 81 had been educated and offered the
pneumococcal immunization.

Petitioner complains that the only evidence of noncompliance under Tag F334 is the
allegations of the surveyor in the SOD, which Petitioner asserts are uncorroborated and
not subject to cross-examination. P. Br. at 2, 8; P. Reply at 5. Petitioner did not object to
the admission of CMS Ex. 3 (the SOD for the May 2012 survey) even though “CMS’s
Final List of Witnesses” filed September 3, 2013, did not list the surveyor who prepared
the SOD for the May 2012 survey as a witness CMS intended to call. Petitioner did not
request a subpoena or an order to compel the availability for cross-examination of the
surveyor who drafted the SOD. Civil Remedies Division Procedure (CRDP) § 9.
Petitioner’s argument that the statements in the SOD are uncorroborated hearsay is
correct, but that does not address the credibility of the statements. Petitioner does not
specifically argue the statements under Tag F334 are not credible and Petitioner offered
no evidence to rebut the statements. Thus, I have no reason not to accept the statements
as credible even though they are uncorroborated hearsay.

Accordingly, I conclude that Petitioner was in violation of 42 C.F.R. § 483.25(n) (Tag
F334) when the survey cycle began on February 27, 2012,” because there was no

° Resident 81 was admitted to the facility on August 5, 2011. Because there is no
evidence of compliance with 42 C.F.R. § 483.25(n)(2)(iv) between the resident’s
admission and the beginning of the survey cycle on February 27, 2012, it could be
concluded that noncompliance began on or shortly after August 5, 2011. For purposes of
this decision, it is not necessary to look back beyond the beginning of the survey cycle or
to resolve the issue of how many days may elapse after admission before the regulation is
violated.
22

evidence in the medical record of Resident 81 that the resident or her legal
representatives were educated on the risks and benefits of the pneumonia immunization,
or that she had taken or declined the immunization, or that the immunization was
medically contraindicated. The deficiency posed a risk for more than minimal harm to
Petitioner’s residents. Therefore, Petitioner was not in substantial compliance with

42 C.F.R. § 483.25(n) (Tag F334) beginning not later than February 27, 2012. The
noncompliance continued until the deficiency was corrected on June 10, 2012.

c. Return to Substantial Compliance

CMS concluded, based on a revisit survey completed on August 10, 2012, that Petitioner
returned to substantial compliance with program participation requirements on August

10, 2012. P. Ex. 7. Petitioner asserts that it corrected all deficiencies cited by the May
2012 survey and returned to substantial compliance not later than June 10, 2012. P. Br. at
16-17. Petitioner may challenge and an ALJ may review whether or not Petitioner
returned to substantial compliance earlier than the date determined by CMS. Foxwood
Springs Living Ctr., DAB No. 2294 at 6-13 (2009).

Petitioner’s plan of correction for the May 2012 survey was admitted as evidence as CMS
Ex. 6 and P. Ex. 5. This plan of correction lists June 10, 2012, as the date Petitioner
completed its plan to correct each of the 13 deficiencies cited. P. Ex. 5. CMS accepted
Petitioner’s plan of correction. Based on the August 10, 2012 revisit survey, CMS
concluded that Petitioner had implemented its plan of correction. But, CMS concluded
that Petitioner did not return to substantial compliance until August 10, 2012, rather than
June 10, 2012. Tr. 144, 152, 78-80.

CMS elicited testimony from Surveyor Doyle, who did not participate in the May 2012
survey, but did participate in the August 10, 2012 revisit survey as the survey team
leader. Tr. 74-78. Surveyor Doyle confirmed that she concluded during the August 2012
revisit that Petitioner had completed its corrective action related to Tag F334 and that
Petitioner was in substantial compliance with Tag F334. Tr. 79-80; CMS Ex. 6 at 17.
Surveyor Doyle testified in response to my questions that she could not recall if she
considered whether Petitioner corrected the deficiencies cited by the May 2012 survey
earlier than August 10, 2012. Tr. 100-04.

Laurie VanderMeer, Regional Director of Clinical Services for Consulate Health Care
was called as a witness by Petitioner. Tr. 124-25. She testified that she assisted with
developing the plan of correction for the May 2012 survey. She testified that she
believed all deficiencies were corrected by June 10, 2012. Tr. 140-46. Brian McCoy,
Regional Vice President of Operations for Consulate Health Care Company, was called
as a witness by Petitioner. Tr. 149-50. Mr. McCoy was also involved in developing the
plans of correction for the surveys, including the May 2012 survey. He testified that the
plan of correction for the May 2012 survey was completed by June 10, 2012. Tr. 152-56.
23

The testimony of Ms. VanderMeer and Mr. McCoy is credible and worthy of weight.
The testimony of Petitioner’s witnesses and the allegations of the plan of correction for
the May 2012 survey are unrebutted by any documentary or testimonial evidence.
Surveyor Doyle testified credibly, but her testimony is limited as she had no recollection
of considering whether Petitioner corrected deficiencies or returned to substantial
compliance prior to August 10, 2012, the date of the revisit survey.

22. A mandatory DPNA was triggered May 27, 2012 as a matter of law
pursuant to section 1819(h)(2)(D) of the Act and continued until
Petitioner completed correction of deficiencies and returned to
substantial compliance with program participation requirements on
June 10, 2012.

23. A CMP of $150 per day from March 30, 2012 through May 10,
2012 and $250 per day from May 11, 2012 through June 10, 2012, is a
reasonable enforcement remedy in this case.

I have concluded that Petitioner was not in substantial compliance with program
participation requirements from February 27, 2012 through June 10, 2012. Pursuant to
section 1819(h)(2) of the Act, the DPNA directed by Congress was triggered after three
months of noncompliance which began the last date of the survey that identified that
Petitioner was not in substantial compliance. Noncompliance was identified by the
survey completed on February 27, 2012. Noncompliance continued through May 27,
2012. Therefore, the mandatory DPNA began on May 27, 2012. There is no issue for
me to resolve regarding the reasonableness of the DPNA. I have also concluded that
Petitioner corrected all deficiencies as of June 10, 2012. Therefore, June 10, 2012 is the
last date of noncompliance and the end of the mandatory DPNA.

If a facility is not in substantial compliance with program requirements, CMS has the
authority to impose one or more of the enforcement remedies listed in 42 C.F.R.

§ 488.406, including a CMP. CMS is authorized to impose a per-day CMP for the
number of days that the facility is not in substantial compliance. 42 C.F.R. § 488.430(a).

If 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: (1) I may not set the CMP at zero or reduce it to zero;
(2) I may not review the exercise of discretion by CMS in selecting to impose a CMP;
and (3) I may only consider the factors specified by 42 C.F.R. § 488.438(f) when
determining the reasonableness of the CMP amount. In determining whether the amount
of a CMP is reasonable, the following factors specified at 42 C.F.R. § 488.438(f) must be
considered: (1) the facility’s history of non-compliance, including repeated deficiencies;
(2) the facility’s financial condition; (3) the seriousness of the deficiencies as set forth at
24

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 facilities neglect, indifference, or disregard for resident care, comfort, and
safety and 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. My review of the reasonableness of the CMP is de novo and
based upon the evidence in the record before me. I am not bound to defer to the CMS
determination of the reasonable amount of the CMP to impose but my authority is limited
by regulation as already explained. I am to determine whether the amount of any CMP
proposed is within reasonable bounds considering the purpose of the Act and regulations.
Emerald Oaks, DAB No. 1800 at 10 ; CarePlex of Silver Spring, DAB No. 1683 at 14-16
(1999); Capitol Hill Cmty. Rehab. & Specialty Care Ctr., DAB No. 1629 (1997).

There are two ranges for a per-day CMP. 42 C.F.R. §§ 488.408, 488.438. The lower

range of CMPs, $50 per day to $3,000 per day, is reserved for
pose immediate jeopardy, but either cause actual harm to resi

harm but have the potential for causing more than minimal har:

§ 488.438(a)(1)(ii). There is no immediate jeopardy in this ca:
of CMPs may be considered. CMS proposed a CMP of $150
2012 through May 10, 2012 and $250 per day from May 11, 2'
returned to substantial compliance. I have concluded that the
was June 10, 2012, and the CMP ends on that date. Petitioner

deficiencies that do not
lents, or cause no actual

m. 42 C.F.R.

se and only the lower range
per day from March 30,
012 until Petitioner

last day of noncompliance
asserted generally in its

request for hearing that the CMP proposed by CMS, particularly the duration of the CMP,

was unreasonable. Petitioner does not specifically challenge tl

ie reasonableness of the

amount of the proposed CMPs.

I have received no evidence of noncompliance by Petitioner except that reflected by the
February 2012, March 2012, and May 2012 surveys. Mr. McCoy testified that the
economic impact of the mandatory DPNA over the period May 27 to August 10, 2012
would be approximately $200,000. Tr. 164. However, Petitioner has not argued that the
proposed CMP would have any significant financial impact upon Petitioner. None of the
alleged deficiencies are alleged to have posed immediate jeopardy or caused actual harm,
though Resident 2 may have suffered additional pain due to the delayed consultation with
her physician. No deficiency was wide-spread. Petitioner was culpable but not highly
culpable. Neglect was reflected by failure to deliver necessary care and services.
However, Petitioner did respond promptly to correct deficiencies. Based on my review
of the regulatory factors, I conclude that a CMP of $150 per day from March 30, 2012
25

through May 10, 2012 and $250 per day from May 11, 2012 through June 10, 2012, is
reasonable.

HI. Conclusion
For the foregoing reasons, I conclude as follows:

e Petitioner was not in substantial compliance with program participation
requirements from February 27, 2012 through June 10, 2012;

e A mandatory DPNA was in effect from May 27, 2012 through June 10, 2012; and

e ACMP of $150 per day from March 30, 2012 through May 10, 2012, and $250
per day from May 11, 2012 through June 10, 2012 is reasonable.

/s/
Keith W. Sickendick
Administrative Law Judge