Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Boivin Family Chiropractic PLLC,
Petitioner,
v.
Centers for Medicare & Medicaid Services.
Docket No. C-13-714
Decision No. CR2873

Date: July 26, 2013

DECISION

Boivin Family Chiropractic PLLC (Petitioner), appeals the Medicare enrollment
determination of National Government Services (NGS), a Medicare contractor, seeking
an earlier Medicare billing date of September 1, 2012. For the reasons explained below,
I grant the Centers for Medicare & Medicaid Services’ (CMS’s) Motion for Summary
Judgment and find that Petitioner’s effective date of enrollment is October 25, 2012, with
a 30-day retrospective billing date of September 26, 2012.

I. Background

Petitioner filed a hearing request (HR) dated April 9, 2013, challenging the effective date
determination’ made by National Government Services (NGS), a Medicare contractor.

* Petitioner uses the term “effective date” to refer to the date on which it could bill for
Medicare services. See, e.g., Petitioner’s Hearing Request (“NGS approved our
application giving us an effective date for 9/26/12”). Under the regulations, the effective
date is the date NGS received an application from Petitioner that it subsequently
approved. The September 26, 2012 date NGS assigned to Petitioner’s application is
Petitioner’s retrospective billing date. The regulation at 42 C.F.R. § 424.521(a)(1),
allows NGS to grant retrospective billing privileges 30 days prior to the date the
CMS submitted a Motion for Summary Judgment and a brief in support of its motion

(CMS Br.), along with eleven exhibits identified as CMS Exs. 1-11. Petitioner filed a
response to the CMS Motion (P. Br.). In the absence of objection, I admit CMS Exs.

1-11 into the record.

II. Applicable Law

The Social Security Act (Act) authorizes the Secretary of Health and Human Services
(Secretary) to promulgate regulations governing the enrollment process for providers and
suppliers. Act §§ 1102, 1866(j); 42 U.S.C. §§ 1302, 1395cc(j). Under the Secretary’s
regulations, a provider or supplier that seeks billing privileges under Medicare must
“submit enrollment information on the applicable enrollment application. Once the
provider or supplier successfully completes the enrollment process . .. CMS enrolls the
provider or supplier into the Medicare program.” 42 C.F.R. § 424.510(a).

Also, a “provider or supplier must submit a complete enrollment application and
supporting documentation to the designated Medicare fee-for-service contractor,” and the
application must include “complete . . . responses to all information requested within
each section as applicable to the provider or supplier type.” 42 C.F.R. § 424.510(d)(1)-

(2).

The effective date of enrollment for physicians and nonphysician practitioners is set as
follows:

The effective date for billing privileges for physicians, nonphysician
practitioners, and physician and nonphysician practitioner organizations is
the later of the date of filing of a Medicare enrollment application that was
subsequently approved by a Medicare contractor or the date an enrolled
physician or nonphysician practitioner first began furnishing services at a
new practice location.

42 C.F.R. § 424.520(d).
II. Issue

The issue in this case is whether CMS’s contractor and CMS properly determined
Petitioner’s effective date of Medicare enrollment.

application was received. NGS determined Petitioner’s effective date of enrollment to be
October 25, 2012, the date it received the application that was ultimately approved. For
clarity, I use “effective date” in this decision to refer to the effective date of enrollment in
Medicare and not the date on which retrospective billing begins.
IV. Analysis

My findings of fact and conclusions of law are set forth in italics and bold in the
discussion captions of this decision.

A. This case is appropriate for summary judgment.

CMS argues that it is entitled to summary judgment. The Departmental Appeals Board
(Board) has stated the standard for summary judgment:

Summary judgment is appropriate when the record shows that there is no
genuine issue as to any material fact, and the moving party is entitled to
judgment as a matter of law. . .. The party moving for summary judgment
bears the initial burden of showing that there are no genuine issues of
material fact for trial and that it is entitled to judgment as a matter of

law. ... To defeat an adequately supported summary judgment motion, the
non-moving party may not rely on the denials in its pleadings or briefs, but
must furnish evidence of a dispute concerning a material fact — a fact that, if
proven, would affect the outcome of the case under governing law. . . . In
determining whether there are genuine issues of material fact for trial, the
reviewer must view the evidence in the light most favorable to the non-
moving party, drawing all reasonable inferences in that party’s favor.

Senior Rehabilitation & Skilled Nursing Center, DAB No. 2300, at 3 (2010) (citations
omitted).

The Board has further explained that the role of an Administrative Law Judge (ALJ) in
deciding a summary judgment motion differs from the ALJ’s role in resolving a case after
a hearing. The ALJ should not assess credibility or evaluate the weight of conflicting
evidence. Holy Cross Village at Notre Dame, Inc., DAB No. 2291, at 5 (2009).

In determining whether summary judgment is appropriate in this case, I accept all of
Petitioner’s factual assertions as true and draw all reasonable inferences in Petitioner’s
favor. I also accept Petitioner’s description and chronology of these events as true.
Therefore, I accept Petitioner’s claim that he submitted an initial Medicare enrollment
application in August 2012, and that the application was received by NGS on August 27,
2012. HR; P. Br. I further accept Petitioner’s claim that he sent a revised application
with supporting documentation to NGS by overnight mail based on the advice Petitioner
received from a Medicare representative. I also accept Petitioner’s assertion that the
revised application sent by overnight mail was not received by NGS until October 15,
2012 because the submission was sent to a Post Office box and not a physical address.
HR. Finally, I accept Petitioner’s assertion that after NGS advised him that his revised

application was denied, Petitioner immediately sent a new application that NGS received
on October 25, 2012. HR.

CMS argues that it is entitled to summary judgment because “the undisputed facts show
that Petitioner’s effective date was properly assigned.” CMS Br. at 1. The record before
me shows that Petitioner has not disputed any fact that is material to my resolution of this
case. Specifically, neither side disputes that NGS did not receive a complete Medicare
enrollment application from Petitioner that it could process to approval earlier than
October 25, 2012. Therefore, I agree with CMS that summary judgment is appropriate in
this case.

B. CMS correctly determined the effective date of Petitioner’s Medicare
enrollment.

Petitioner, a chiropractor, was enrolled in the Medicare program as a practitioner since
2003. On August 31, 2012, Petitioner left a group practice in order to open his own
practice. On August 27, 2012, Petitioner submitted a Medicare enrollment application
(Form CMS-855I) to NGS, he began seeing patients at his new location on September 1,
2012. CMS Ex. 1, at 1, 17; P. Br. After reviewing Petitioner’s enrollment application,
NGS sent Petitioner a letter dated September 14, 2012 requesting that Petitioner make
revisions to the enrollment application and submit supporting documentation. The letter
noted that in order to avoid rejection or denial of the application, the revisions and
additional documentation had to be furnished to NGS within 30 days of the date on the
notice. CMS Ex. 2. Thirty days from the September 14, 2012 notice was October 14,
2012, a Sunday. On October 15, 2012, NGS received the application from Petitioner.
Upon review of the application NGS noted that it was not complete. CMS Ex. 3. On
October 19, 2012, NGS notified Petitioner that his enrollment application was rejected
because a “response was not received, or the requested documents(s) we received were
incomplete or not sufficient.” CMS Ex. 4.

Petitioner submitted a second Medicare enrollment application (Form CMS-855]) on
October 25, 2012. CMS Ex. 5. NGS received the enrollment application on October 25,
2012, and requested additional information which Petitioner provided. CMS Exs. 6, 7.
On February 16, 2012, NGS approved the application and granted Petitioner the effective
date of October 25, 2012, with a retroactive billing date of September 26, 2012. CMS
Exs. 5, 7, 8.

Petitioner does not dispute the facts as recited above. Moreover, Petitioner offers no
evidence to counter the fact that it was not until October 25, 2012 that NGS received an
enrollment application from Petitioner that it could subsequently process to approval.

As noted above, the effective date for enrollment for physicians and nonphysician
practitioners is “the later of the date of filing of a Medicare enrollment application that
was subsequently approved by a Medicare contractor or the date an enrolled physician or
nonphysician practitioner first began furnishing services at a new practice location.” The
“date of filing” is the date that the Medicare contractor “receives” a signed provider
enrollment application that the Medicare contractor is able to process to approval.

42 C.F.R. § 424.520; 73 Fed. Reg. 69,725, 69,769 (Nov. 19, 2008). It is well settled that
the date of filing is the date the Medicare contractor receives an approvable application.
Caroline Lott Douglas, PA, DAB CR2406 (2011); Rizwan Sadiq, M.D., DAB CR2401
(2011); Jennifer Tarr, M.D., DAB CR2299 (2010); Michael Majette, D.C., DAB CR2142
(2010); Roland J. Pua, M.D., DAB CR2163 (2010).

Although Petitioner started providing services to Medicare beneficiaries as of September
4, 2012, the facts of this case show that it was not until October 25, 2012 that NGS
received a Medicare enrollment application from Petitioner that it could process to
approval. The revised application Petitioner submitted to NGS did not contain all the
information NGS had requested. The effective date of Medicare enrollment depends on
the date NGS first received an approvable application. Therefore, the correct effective
date of Petitioner’s enrollment remains October 25, 2012, with a retrospective billing date
of September 26, 2012. 42 C.F.R. § 424.520(d).

The arguments Petitioner advances to support an earlier billing date amount to claims of
equitable estoppel, and provide no bases for me to provide Petitioner with the relief he
seeks. Petitioner states that as a previous Medicare provider he understood that he could
continue to provide services in his new practice without disruptions, and that to ensure a
smooth transition without delay, in advance of his relocation he timely notified CMS of
the changes using the application process. Petitioner also claims that NGS did not
receive the revised application until October 15, 2012 because he sent the application by
overnight mail to a Post Office box, rather than to a physical address, based on the advice
Petitioner received from a Medicare Representative. HR; P. Br. Petitioner also maintains
that not receiving reimbursement for services he provided to Medicare beneficiaries from
September 1 through 25, results in a significant loss of income to his practice. P. Br.

It is well-established by federal case law, and in Board precedent, that: (1) estoppel
cannot be the basis to require payment of funds from the federal government; (2) estoppel
can lie against the government, if at all, only on a showing of affirmative misconduct,
such as fraud; and (3) I am not authorized to order payment contrary to law based on
equitable grounds. See, e.g., Oklahoma Heart Hospital, DAB No. 2183, at 16 (2008);
Wade Pediatrics, DAB No. 2153, at 22 n.9 (2008), aff'd, 567 F.3d 1202 (10th Cir. 2009);
Office of Personnel Management v. Richmond, 496 U.S. 414 (1990); Heckler v.
Community Health Services of Crawford County, Inc., 467 U.S. 51 (1984). Petitioner
alleges no affirmative misconduct against the government and I cannot grant the relief
Petitioner requests.
6

V. Conclusion

For the reasons explained above, and based on the undisputed fact that NGS did not
receive an enrollment application from Petitioner which it could process to approval until
October 25, 2012, I conclude that Petitioner’s effective date of enrollment was correctly
determined to be October 25, 2012, with a 30-day retrospective billing date starting
September 26, 2012.

/s/
Richard J. Smith
Administrative Law Judge


Department of Health and Human Services

DEPARTMENTAL APPEALS BOARD

Civil Remedies Division
Janine L. Wright,
(OI File No. H-12-41063-9),
Petitioner,
v.

The Inspector General.
Docket No. C-13-327
Decision No. CR2872

Date: July 26, 2013

DECISION

Petitioner, Janine L. Wright, was a speech language pathologist, licensed in the State of
Georgia, who was convicted of felony Medicaid fraud. Based on her conviction, the

Inspector General (I.G.
Medicare, Medicaid, a

.) has excluded her for ten years from participation in the
nd all federal health care programs, as authorized by section

1128(a)(1) of the Social Security Act (Act). Petitioner now challenges the exclusion. For

the reasons discussed
ten-year exclusion fal

I. Background

Petitioner Wright own
Service, through whic!

below, I find that the I.G. properly excluded Petitioner and that the
s within a reasonable range.

ed and operated S.L.C. Professional Consultations and Referral
she provided speech language pathology services to children,

many of whom received treatment under the state’s Medicaid program. I.G. Ex. 3 at 2-3.

Following a jury trial,

she was convicted of submitting false claims to Medicaid and to

managed care organizations that serve Medicaid recipients. I.G. Ex. 2; I.G. Ex. 3 at 3.

The state court entered judgment against her on February 9, 2012. I.G. Ex. 2; P. Br. at 1.
In a letter dated November 30, 2012, the I.G. notified Petitioner that she was excluded
from participation in Medicare, Medicaid, and all federal health care programs for a
period of ten years, because she had been convicted of a criminal offense related to the
delivery of an item or service under Medicare or a state health care program. The letter
explained that section 1128(a)(1) of the Act authorizes the exclusion. LG. Ex. 1.
Petitioner requested review, and the matter is before me for resolution.

Each party submitted an initial brief (1G. Br.; P. Br.). The I.G. submitted three exhibits
(LG. Exs. 1-3) and Petitioner submitted three exhibits (P. Exs. 1-3). The I.G. submitted a
reply brief (I.G. Reply). In the absence of an objection, I admit into evidence LG. Exs.
1-3 and P. Exs. 1-3.

IL. Issues

The issues before me are: 1) whether Petitioner was convicted of a criminal offense
related to the delivery of an item or service under Medicare or a state health care program
within the meaning of section 1128(a)(1), thus providing a basis for excluding her from
program participation; and 2) if so, whether the length of the exclusion (ten years) is
reasonable.

III. Discussion

A, Petitioner must be excluded from program participation,
because she was convicted of a criminal offense related to
the delivery of an item or service under Medicare or a state
health care Program within the meaning of section
1128(a)(1).

Section 1128(a)(1) of the Act mandates that the Secretary of Health and Human Services
exclude an individual who has been convicted under federal or state law of a criminal
offense related to the delivery of an item or service under Medicare or a state health care
program. 42 C.F.R. § 1001.101(a). The term “state health care program” includes a
state’s Medicaid program. Act § 1128(h)(1). Because Petitioner Wright was indicted
and convicted of presenting fraudulent claims to Medicaid, she obviously committed an
offense related to the delivery of items or services under a state health care program and
must be excluded from program participation. I.G. Exs. 2, 3.

Petitioner nevertheless argues that she is not subject to exclusion because her conviction
is “under review” before various tribunals. In Petitioner’s view, the I.G. may exclude her

' My findings of fact and conclusions of law are set forth, in italics and bold, in the
discussion captions of this opinion.
only if her underlying conviction is not reviewable and only if she “may not collaterally
attack the conviction in . . . her exclusion appeal.” P. Br. at 2. Petitioner misunderstands
the statute and regulations. Hers is a “conviction” within the meaning of section 1128,
which specifically provides that “an individual or entity is considered to have been
“convicted” when a court has entered a judgment of conviction “regardless of whether
there is an appeal pending... .” Act § 1128(i)(1). Further, the regulations explicitly
preclude any collateral attack on an underlying conviction.

When the exclusion is based on the existence of a criminal
conviction .. . where the facts were adjudicated and a final
decision was made, the basis for the underlying conviction . .
. is not reviewable and the individual or entity may not
collaterally attack it, either on substantive or procedural
grounds, in this appeal.

42 C.F.R. § 1001.2007(d); Joann Fletcher Cash, DAB No. 1725 (2000); Chander
Kachoria, R.Ph., DAB No. 1380 at 8 (1993) (“There is no reason to ‘unnecessarily
encumber the exclusion process’ with efforts to reexamine the fairness of state
convictions.”); Young Moon, M.D., DAB CR1572 (2007).

Thus, Petitioner was convicted of a program-related crime and must be excluded for at
least five years. I now consider whether the length of her exclusion, beyond five years,
falls within a reasonable range.

B. Based on the aggravating factors present in this case, the
ten-year exclusion falls within a reasonable range.

An exclusion under section 1128(a)(1) must be for a minimum period of five years.

Act, § 1128(c)(3)(B); 42 C.F.R. §§ 1001.102(a), 1001.2007(a)(2). Federal regulations set
forth criteria for lengthening exclusions beyond the five-year minimum. 42 C.F.R.

§ 1001.102(b). Evidence that does not pertain to one of the aggravating or mitigating
factors listed in the regulation may not be used to decide whether an exclusion of a
particular length is reasonable.

Among the factors that may serve as bases for lengthening the period of exclusion are
three relied on by the LG. in determining the length of Petitioner’s exclusion: 1) the acts
resulting in the conviction, or similar acts, resulted in a financial loss to Medicare and
state health care programs of $5,000 or more; 2) the acts that resulted in the conviction,
or similar acts, were committed over a period of one year or more; and 3) the sentence
imposed by the court included incarceration. 42 C.F.R. § 1001.102(b). The presence of
an aggravating factor or factors not offset by any mitigating factor or factors justifies
lengthening the mandatory period of exclusion.
Program financial loss. Petitioners’ actions resulted in program financial losses more
than ten times greater than the $5,000 threshold for aggravation. The court ordered her to
pay $59,570.25 in restitution to the state Medicaid program. IG. Ex. 3. Restitution has
long been considered a reasonable measure of program losses. Jason Hollady, M.D.,
DAB No. 1855 (2002). Because the financial losses were significantly in excess of the
threshold amount for aggravation, the I.G. may justifiably increase significantly
Petitioner’s period of exclusion. See Jeremy Robinson, DAB No. 1905 (2004); Donald
A. Burstein, PhD., DAB No. 1865 (2003).

Duration of crime (42 C.F.R. § 1001.102(b)(2)). Petitioner was convicted of criminal
acts that were committed over a period of approximately eighteen months, beginning “on
or about June 6, 2008 and continuing through on or about January 25, 2010.” I.G. Ex. 3 at
2.

Incarceration (42 C.F.R. § 1001.102(b)(5)). The sentence imposed by the criminal court
included a substantial prison sentence — ten years, although she is required to serve four
years, followed by six years probation, provided she meets certain conditions. I.G. Ex. 2.
See Jason Hollady, M.D., DAB No. 1855 at 12 (2002) (characterizing a nine-month
incarceration as “relatively substantial”); Jeremy Robinson, DAB No. 1905 (2004).

C. No mitigating factors justify decreasing the period of
exclusion.

The regulations consider mitigating just three factors: 1) a petitioner was convicted of
three or fewer misdemeanor offenses and the resulting financial loss to the program was
less than $1,500; 2) the record in the criminal proceedings demonstrates that a petitioner
had a mental, physical, or emotional condition that reduced his culpability; and 3) a
petitioner’s cooperation with federal or state officials resulted in others being convicted
or excluded, or additional cases being investigated, or a civil money penalty being
imposed. 42 C.F.R. § 1001.102(c). Characterizing a mitigating factor as “‘in the nature
of an affirmative defense,” the Departmental Appeals Board has ruled that Petitioner has
the burden of proving any mitigating factor by a preponderance of the evidence. Barry
D. Garfinkel, M.D., DAB No. 1572 at 8 (1996).

Obviously, because Petitioner was convicted of a felony that involved program financial
losses many times greater than $1,500, the first factor does not apply here. Nor does
Petitioner claim any mental, physical, or emotional condition that reduced her culpability.
She does not allege that she cooperated with government officials.

So long as the period of exclusion is within a reasonable range, based on demonstrated
criteria, I have no authority to change it. Joann Fletcher Cash, DAB No. 1725 at 7
(2000), citing 57 Fed. Reg. 3298, 3321 (1992). In this case, Petitioner’s crime
demonstrates that she presents significant risks to the integrity of health care programs.
She engaged in illegal conduct that cost the Medicaid program a significant amount of
money. Her criminal conduct lasted more than a year, and resulted in a significant prison
sentence. No mitigating factors offset the aggravating factors. I therefore find that the
ten-year exclusion falls within a reasonable range.

IV. Conclusion

For these reasons, I conclude that the I.G. properly excluded Petitioner from participation
in Medicare, Medicaid and all federal health care programs, and I sustain as reasonable
the period of exclusion.

/s/
Carolyn Cozad Hughes
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Altercare of Mentor,
(CCN: 36-6011),

Petitioner,
v.
Centers for Medicare & Medicaid Services.
Docket No. C-12-1165
Decision No. CR2870

Date: July 25, 2013

DECISION

In this case, I again consider a long-term care facility’s obligation to prevent pressure
sores. Specifically, must facility staff ensure that the elastic on a resident’s underwear is
not so tight that it puts the resident at risk?

Petitioner, Altercare of Mentor (Petitioner or facility), is a long-term care facility, located
in Mentor, Ohio, that participates in the Medicare program. Based on a survey completed
March 7, 2012, the Centers for Medicare & Medicaid Services (CMS) determined that
the facility was not in substantial compliance with Medicare program requirements.

CMS imposed a $3,200 per instance civil money penalty (CMP) for one of the cited
deficiencies: 42 C.F.R. § 483.25(c) (quality of care: prevention and treatment of
pressure sores). Petitioner appealed.

For the reasons set forth below, I find that the facility was not in substantial compliance
with the quality of care requirements for the prevention and treatment of pressure sores
and that the modest penalty imposed is reasonable.
I. Background

The Social Security Act (Act) sets forth requirements for nursing facility participation 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 CFR. § 488.301.

The Secretary contracts with state survey agencies to conduct periodic surveys to
determine whether skilled nursing facilities are in substantial compliance. Act § 1864(a);
42 C.F.R. § 488.20. The regulations require that each facility be surveyed once every
twelve months and more often, if necessary, to ensure that identified deficiencies are
corrected. Act § 1819(g)(2)(A); 42 C.F.R. §§ 488.20(a); 488.308.

Here, following a recertification survey completed March 7, 2012, CMS determined that
the facility was not in substantial compliance with four Medicare participation
requirements, specifically:

42 C.F.R. § 483.25(a)(2) (Tag F311 — quality of care: activities of daily living);

42 C.F.R. § 483.25(c) (Tag F314 — prevention/treatment of pressure sores);

42 C.F.R. § 483.25(h)(2) (Tag F323 — accident prevention); and

42 C.F.R. § 483.65 (Tag F441 — infection control).

CMS Ex. 13. CMS subsequently determined that the facility returned to substantial
compliance on March 30, 2012, and imposed against the facility a $3,200 per instance
CMP, based solely on the deficiencies cited under 42 C.F.R. § 483.25(c). CMS Ex. 1.

Petitioner timely requested a hearing.

On March 20, 2013, I held a hearing, via video teleconference, from the offices of the
Departmental Appeals Board in Washington, D.C. Counsel and witnesses convened in
Beechwood, Ohio. Transcript (Tr.) 4. Ms. Joan M. Zanzola appeared on behalf of CMS,
and Mr. Christopher Tost appeared on behalf of the Petitioner.

I have admitted into evidence CMS Exhibits (CMS Exs.) 1-22 and Petitioner’s Exhibits
(P. Exs.) 1-4 and P. Ex. 6. Tr. 5-6; Summary of Prehearing Conference and Order at 2
(February 8, 2013). The parties have filed pre-hearing briefs (CMS Pre-hrg. Br.; P. Pre-
hrg. Br.), post-hearing briefs (CMS Post-hrg. Br.; P. Post-hrg. Br.) and CMS filed a reply
brief (CMS Reply).

IL. Issues
The issues before me are:

1. Was the facility in substantial compliance with 42 C.F.R. § 483.25(c) (Tag
F314 — prevention/treatment of pressure sores); and

2. Ifthe facility was not in substantial compliance with 42 C.F.R. § 483.25(c), is
the penalty imposed -- $3,200 per instance -- reasonable?

III. Discussion

A, The facility was not in substantial compliance with 42 C.F.R. § 483.25(c)
because it failed to take all necessary precautions to prevent pressure sores from
developing.

Program requirements. Under the statute and the “quality of care” regulation, each
resident must receive, and the facility must provide, the necessary care and services to
allow a resident to attain or maintain the highest practicable physical, mental, and
psychosocial well-being, in accordance with the resident’s comprehensive assessment
and plan of care. Act § 1819(b); 42 C.F.R. § 483.25. To this end, the facility must
(among other requirements) ensure that a resident who enters the facility without pressure
sores does not develop them, unless his/her clinical condition shows that they were
unavoidable, based on the resident’s comprehensive assessment. 42 C.F.R.

§ 483.25(c)(1). If the resident has pressure sores, the facility must ensure that he/she
receives the treatment and services necessary to promote healing, prevent infection, and
prevent new sores from developing. 42 C.F.R. § 483.25(c)(2). In assessing the facility’s
compliance with this requirement, the relevant question is: did the facility “take all
necessary precautions” to prevent new sores from developing. If they did so, and the
resident develops sores anyway, I could find no deficiency. But if the evidence
establishes that the facility fell short of taking all necessary precautions, then the
regulation is violated. Senior Rehab. and Skilled Nursing Ctr., DAB No. 2300 at 13-14
(2010), aff'd , Senior Rehab. and Skilled Nursing Ctr. v. HHS, No. 10-60241 (December
20, 2010); Koester Pavilion, DAB 1750, at 32 (2000).

' My findings of fact and conclusions of law are set forth, in bold and italics, as captions
in the discussion section of this decision.
Resident 198 (R198). R198 was a 93-year-old woman, admitted to the facility on
October 19, 2011, following surgical repair of a fractured hip. Her diagnoses included
neuropathy, confusion, and muscular atrophy. Tr. 12-13; CMS Ex. 6 at 9. Among other
problems, her mobility was impaired and she was incontinent of bowel and bladder.

CMS Ex. 12 at 10; P. Ex. 1 at 1. She was dependent on staff to dress her, and at least two
persons were required to complete that task. CMS Ex. 6 at 9; CMS Ex. 22 at 3 (Gilligan
Decl. § 8). At the time of her admission, she suffered from unhealed pressure sores on
her right heel and left buttock. CMS Ex. 12 at 8. Facility staff recognized that she was at
risk for further skin breakdown and, in a care plan dated October 28, 2011, listed some
interventions (e.g., dietary consultation; encouraging her not to “slide/scoot” when in bed
or up in a chair; float heels in bed, etc.) geared toward preventing that. CMS Ex. 12 at
10; CMS Ex. 15 at 8-9.

In a nurse’s note, dated November 20, 2011 at 4:28 p.m., Licensed Practical Nurse (LPN)
David Moore documented a bruise on the resident’s right inner thigh “consistent with
brief positioning.” The resident denied pain, but said “It’s obviously from my underwear,
but it wasn’t hurting at all.” CMS Ex. 12 at 1. According to the note, LPN Moore
“educated” staff about the proper size of briefs and ensuring that briefs fit properly before
placing the resident in her wheel chair. LPN Moore testified that he observed the area
and determined that “the bruise was consistent with and likely caused by the elastic band
from the resident’s undergarment briefs.” CMS Ex. 6 at 9; CMS Ex. 12 at 1; P. Ex. 4 at 2
(Moore Decl. {f 7, 8); see Tr. 45-46. Both parties attribute the bruise to the resident’s ill-
fitting underwear. P. Br. at 2.

According to nurses’ notes, on November 23, 2011, the bruise was an open blister. CMS
Ex. 6 at 9; CMS Ex. 12 at 4. On that day, staff began tracking the wound. Staff
described it as “a Stage II pressure wound (partial thickness skin loss involving
epidermis, dermis, or both) on her right inner thigh measuring 7.0 centimeters (cm) long
by 0.5 cm wide by less than 0.1 cm deep.” CMS Ex. 6 at 9-10.2- According to the report,

> Pressure sores (also referred to as pressure ulcers or decubitus ulcers) are classified into
stages, based on the extent of the damage to skin and underlying tissues. At stage I, the
skin may appear reddened, /ike a bruise. Although the integrity of the skin remains
intact, the area is at high risk of further breakdown, so it is crucial that the area be
identified promptly and treated properly. At stage II, the skin breaks open, wears away,
and forms an ulcer. At stage III, the sore worsens and extends beneath the skin surface,
forming a small crater, presenting a high risk of tissue death and infection. By stage IV,
deeper tissues (muscles, tendons, bones) suffer extensive damage, which can cause
serious complications, such as osteomyelitis (infection of the bone) or sepsis (infection
carried through the blood). Journal of the American Medical Association, Vol. 296, No.
8, at 1020 (available at www.jama.com).

the resident complained of pain at the wound site, at level 3 on a scale of 1 to 10. CMS
Ex. 6 at 10; CMS Ex. 12 at 6.

On November 29, a registered nurse described “an elongated linear pressure, like a line
that split open, area from elastic underwear sliding and pinching skin on thigh.” The area
was 14 cm X 0.3 cm X 0.1 cm and the most medial 6 cm had yellow slough; the
remaining 8 cm was “beefy red granulation.” No odor, no drainage, and the resident
denied pain. CMS Ex. 12 at 2, 7.

Thereafter, R198 no longer wore the ill-fitting briefs. CMS Ex. 13 at 8. The facility
promised that other residents wearing incontinence briefs would be fitted by a licensed
nurse, using the Attends sizing guide, and the size would be included in the resident’s
care plan. CMS Ex. 13 at 8.

No one disputes that R198 was especially vulnerable to skin breakdown and the
development of pressure sores. To prevent them, staff needed to be especially vigilant.
Everyone agrees that wearing tight-fitting clothes increases the individual’s risk for
developing pressure ulcers. CMS Ex. 21 at 2. Ata minimum, staff should have insured
that her clothing fit properly and did not put her at risk. Tr. 38. At least two staff
members dressed her every day, and numerous others changed her due to her
incontinence. I find it inconceivable that staff would not have noticed that the elastic on
er underwear was too tight, if they knew to check and if they knew how to check.
Indeed, when LPN Moore checked the bruise on her inner thigh, he immediately
identified the problem.

Petitioner now argues that, until the bruises appeared, facility staff were not obligated to
identify ill-fitting underwear as a risk. P. Post-hrg. Br. at 2-3. I find no support for this
position. That tight-fitting clothes increase the risk of pressure sores is well known.
CMS Ex. 21 at 2. Surveyor Melissa Gilligan, who is a registered nurse, testified that staff
should have ensured that R198’s undergarments were not too tight. CMS Ex. 22 at 3
(Gilligan Decl. J 8). She characterized as “routine” staffs checking the fit of
undergarments when dressing a resident. Tr. 38. Petitioner’s own witness agreed. In his
testimony, LPN Moore conceded that staff were responsible for checking the fit of the
resident’s undergarments, but he claimed that they did so: “[E]very time she [was]
dressed by anyone in the facility that’s something that is checked for.” Tr. 44. I did not
find this claim credible. I see no other support for it in the record. R198’s care plan did
not instruct staff to check the fit of her underwear, and no records document that any one
did so. The facility produced no in-service training records to show that it trained staff to
check clothing for proper fit.

Moreover, LPN Moore made this claim for the first time under cross-examination. In his
written direct testimony, he said that he observed the bruises on November 20, replaced
the underwear with a larger size, discussed the issue with staff, and educated them
regarding the use of proper-sized briefs. He also said that, in the days following, he
“personally monitored” the fit of R198’s undergarments and he “routinely reminded
facility staff regarding the need for proper fitting briefs.” P. Ex. 4 at 2 (Moore Decl.
11, 12, 14). He never suggested that staff had been checking the fit all along.

Further, the evidence establishes that R198’s hip was swollen following surgery. Tr. 48,
54. That alone should have triggered a reassessment as to the fit of her underwear.
Underwear that may once have fit perfectly well would be too small if her hip and leg
were swollen.

I am not persuaded that the facility avoids its responsibilities in this regard because the
resident’s son provided the underwear. He was not in a position to assess whether it fit
properly; not only is he not a health care professional, charged with knowing the risks
posed by tight elastic, he was not even in a position to know whether the underwear fit
properly, since he did not dress or change his mother. As the Board determined in a
similar context involving ill-fitting shoes provided by a resident’s family:

While it is understandable that a facility would wish to
accommodate the preferences of a resident or his/her family
members, the facility has an obligation under the regulations
to take any necessary precautions to prevent pressure sores.
Certainly, the facility cannot shift the blame for its inaction to
the [family for] not providing different shoes at their request.
The facility should accommodate the family’s preferences as
much as possible, but must still take necessary measures to
prevent the predictable consequences of pressure sores.

Koester Pavilion, DAB No. 1750 at 15. Unlike the family in Koester, who very much
insisted that she wear the shoes they provided, no evidence suggests that R198 or her
family had any objections to changing the size of her undergarments.

Nor am I persuaded that the facility could not have been expected to act earlier because
R198 did not complain about her underwear and, until November 20, she displayed no
visible markings. As CMS points out, R198 suffered from neuropathy, which, as the
facility well knew, can cause numbness. CMS Ex. 22 at 3 (Gilligan Decl. § 6). She was
unable to tell when she was urinating (Tr. 49); when the bruise appeared, she denied pain
(CMS Ex. 12 at 1); even when she had an open split along her thigh, she apparently
experienced no pain. CMS Ex. 12 at 2, 7. Nor could she even be expected to recognize
that the elastic around her thighs was too tight; many people regularly wear tight clothing
without recognizing that it does not fit properly.

Petitioner also points out that R198’s care plan included interventions aimed at
preventing pressure sores. No one has suggested that these were not appropriate.
However, by themselves, they were not adequate to prevent pressure sores from
developing. See Bradford County Manor, DAB No. 2181 at 20 (2008).

I agree that, at a minimum, staff should have ensured that R198’s undergarments fit
properly. Failing to do that meant that they were not “taking all necessary precautions”
to prevent new sores from developing. The facility was therefore not in substantial
compliance with 42 C.F.R. § 483.25(c).

B. The penalty imposed -- $ 3,200 per instance -- is reasonable.

To determine whether a CMP is reasonable, I apply the factors listed in 42 C.F.R.

§ 488.438(f): 1) the facility’s history of noncompliance; 2) the facility’s financial
condition; 3) factors specified in 42 C.F.R. § 488.404; and 4) the facility’s degree of
culpability, which includes neglect, indifference, or disregard for resident care, comfort
or safety. The absence of culpability is not a mitigating factor. The factors in 42 C.F.R.
§ 488.404 include: 1) the scope and severity of the deficiency; 2) the relationship of the
deficiency to other deficiencies resulting in noncompliance; and 3) the facility’s prior
istory of noncompliance in general and specifically with reference to the cited
deficiencies.

I consider whether the evidence supports a finding that the amount of the CMP is at a
level reasonably related to an effort to produce corrective action by a provider with the
ind of deficiencies found, and in light of the section 488.438(f) factors. I am neither
bound to defer to CMS’s factual assertions, nor free to make a wholly independent choice
of remedies without regard for CMS’s discretion. Barn Hill Care Ctr., DAB No. 1848 at
21 (2002); Cmty. Nursing Home, DAB No. 1807 at 22 et seg. (2002); Emerald Oaks,
DAB No. 1800 at 9 (2001); CarePlex of Silver Spring, DAB No. 1638 at 8 (1999).

Here, the penalty imposed -- $ 3,200 per instance -- is at the low end of the penalty range
for per-instance CMPs ($1,000-$10,000). 42 C.F.R. §§ 488.408(d), 488.438(a)(2).

[he facility has a less-than-stellar history, and this was a repeat deficiency. In November
2009, it was not in substantial compliance with the same regulation, 42 C.F.R.

§ 483.25(c) (Tag F314). Nor was it then substantially compliant with 42 C.F.R.

§ 483.25(h) (Tag F323 — accident prevention). In January 2011, it was not in substantial
compliance with two regulations: 42 C.F.R. § 483.15(a) (Tag F241—dignity and respect)
and 42 C.F.R. § 483.65 (Tag F441 — infection control). CMS Ex. 17. The facility’s
history alone is sufficient to justify this modest CMP.

Petitioner does not claim that its financial condition affects its ability to pay this small
CMP.
With respect to the remaining factors, I find it more likely that facility staff acted (or
failed to act) out of ignorance rather than malice or indifference. I see no evidence that,
prior to November 20, anyone told staff how important it is that the residents’ clothes fit
properly. Staff were simply not aware of the potential damage that tight elastic can
cause. For not properly training its staff, the facility is culpable.

For these reasons, I find the penalties imposed reasonable.
IV. Conclusion

CMS properly determined that the facility was not in substantial compliance with 42
C.F.R. § 483.25(c) and I affirm, as reasonable, the penalty imposed.

/s/
Carolyn Cozad Hughes
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Orlando D. Rodriguez, M.D.,
Petitioner,
v.
Centers for Medicare & Medicaid Services.
Docket No. C-13-523
Decision No. CR2869

Date: July 24, 2013

DECISION

First Coast Service Options, Inc. (First Coast), an administrative contractor acting on
behalf of the Centers for Medicare & Medicaid Services (CMS), determined that
Petitioner’s effective date of enrollment in the Medicare program was June 14, 2012,
with a retrospective billing period starting on May 15, 2012. Petitioner appealed. For the
reasons stated below, I modify First Coast’s determination. Petitioner’s effective date of
enrollment in the Medicare program is now June 6, 2012. Further, as explained below,
May 15, 2012, will continue to be the starting date of Petitioner’s retrospective billing
privileges unless CMS or First Coast modifies that date.

I. Background and Procedural History

Petitioner is a physician located in Miami, Florida, and one of the owners of JMH
Internal Medicine Specialist, LLC (JMH). CMS Exhibits (Exs.) 1, 3, 5. JMH submitted
a Medicare enrollment application (Form CMS-855B for Clinics/Group Practices and
Certain Other Suppliers) and was enrolled in Medicare effective January 11, 2012. CMS
Exs. 3, 5. Petitioner submitted a Medicare supplier enrollment application (Form CMS-
855R, Medicare Enrollment Application — Reassignment of Medicare Benefits) with First
Coast via the Provider Enrollment, Chain and Ownership System (PECOS) on June 6,
2012. CMS Ex. 1. Ina September 12, 2012 initial determination, First Coast approved
Petitioner’s application to reassign his benefits to JMH and permitted Petitioner to bill
retrospectively for his services, but only as of 30 days prior to June 14, 2012, the date
First Coast believed that it received Petitioner’s Form CMS-855R. CMS Ex. 2.

Petitioner filed a corrective action plan (CAP); however, First Coast denied the CAP
because Petitioner’s submission did not meet the criteria to be considered a CAP. CMS
Ex. 3. Petitioner then filed a timely request for reconsideration with First Coast. CMS
Ex. 3. However, First Coast upheld the initial determination. CMS Ex. 4. On February
4, 2013, Petitioner timely filed his request for hearing (RFH) and I was assigned to hear
and decide this case. Petitioner attached five documents to his RFH.

In response to an Acknowledgment and Pre-hearing Order (Order) that I issued on March
4, 2013, CMS filed a motion for summary judgment and brief (CMS Br.) and five
exhibits (CMS Exs. 1-5). Petitioner failed to timely respond to CMS’s motion for
summary judgment and also failed to timely file the pre-hearing exchange required under
my March 14 Order. I issued an Order to Show Cause on May 30, 2013, giving
Petitioner the opportunity to explain why I should not dismiss his case for abandonment.
Petitioner responded on June 10, 2013, asserting that he rested his case with the
submission of his RFH and supporting documents. See Petitioner’s Order to Show Cause
Response (P. OSC Response). Because Petitioner presented his entire case with his RFH,
I will adjudicate this case on the merits.

In the absence of an objection, I admit CMS Exs. | through 5 into the record. Although
Petitioner did not submit any marked exhibits, I admitted Petitioner’s RFH and three of
his accompanying documents to the record as CMS Exs. 2, 3, 4, and 5. Ihave reviewed
the two remaining documents that Petitioner filed with his RFH and determined that they
do not affect the outcome of this case. However, while I will not formally admit those
documents as exhibits, I have fully reviewed them and both documents remain in the
record as part of Petitioner’s RFH.

My March 14, 2013 Order states that the parties must submit written direct testimony for
each proposed witness and that an in-person hearing is only necessary if the opposing
party requests an opportunity to cross-examine a witness. Order {ff 8 -11; Vandalia Park,
DAB No. 1940 (2004); Pacific Regency Arvin, DAB No. 1823, at 8 (2002) (holding that
the use of written direct testimony for witnesses is permissible so long as the opposing
party has the opportunity to cross-examine those witnesses). Neither party provided a list
of proposed witnesses or written direct testimony. Consequently, I will not hold an in-
person hearing in this matter. See Kate E. Paylo, D.O., DAB CR2232, at 9 (2010). The
record is closed and I decide this matter based on the written record. Order § 11.
IL. Discussion
A. Issue

Whether CMS had a legitimate basis for establishing June 14, 2012, as the effective date
of Petitioner’s Medicare enrollment (i.e., reassignment of Medicare benefits) and May
15, 2012, as the beginning of Petitioner’s retrospective billing period.

B. Findings of Fact, Conclusions of Law, and Analysis!

The Social Security Act (Act) authorizes the Secretary of Health and Human Services
(Secretary) to promulgate regulations governing the enrollment process for providers and
suppliers.” 42 U.S.C. §§ 1302, 1395cc(j). Under the Secretary’s regulations, a provider
or supplier that seeks billing privileges under Medicare must “submit enrollment
information on the applicable enrollment application. Once the provider or supplier
successfully completes the enrollment process . .. CMS enrolls the provider or supplier
into the Medicare program.” 42 C.F.R. § 424.510(a).

1. First Coast received Petitioner’s completed and signed Form CMS-
855R via PECOS on June 6, 2012.

Petitioner electronically signed a Form CMS-855R on June 6, 2012, relating to the
reassignment of Medicare billing privileges to JMH. CMS Ex. 1, at 3. CMS concedes
this date of receipt even though it is earlier than the date of receipt identified by First
Coast or Petitioner. CMS Br. at 3 n.2. Therefore, I find that First Coast received
Petitioner’s Form CMS-855R on June 6, 2012.

2. The date of receipt of the Form CMS-855R, processed to completion,
is the effective date of Petitioner’s enrollment in Medicare.

On September 12, 2012, First Coast approved Petitioner’s Form CMS-855R. CMS Ex. 2.
First Coast set May 15, 2012, as Petitioner’s “effective date.” CMS Ex. 2, at 1. On
reconsideration, First Coast upheld May 15, 2012 as the “effective date,” noting that this
date was 30 days prior to the date First Coast received Petitioner’s enrollment
application. CMS Ex. 4, at 2, 3.

' My findings of fact and conclusions of law are set forth in italics and bold font.

> Petitioner is considered a “supplier” for purposes of the Act and the regulations. See
42 U.S.C. §§ 1395x(d), 1395x(u); see also 42 C.F.R. § 498.2. A “supplier” furnishes
services under Medicare and the term applies to physicians or other practitioners that are
not included within the definition of the phrase “provider of services.” 42 U.S.C.

§ 1395x(d).
The relevant regulation concerning the effective date of Medicare enrollment states:

The effective date for billing privileges for physicians, nonphysician
practitioners, and physician and nonphysician practitioner organizations is
the later of the date of filing of a Medicare enrollment application that was
subsequently approved by a Medicare contractor or the date an enrolled
physician or nonphysician practitioner first began furnishing services at a
new practice location.

42 C.F.R. § 424.520(d) (emphasis added). The “date of filing” is the date that the
Medicare contractor “receives” a signed provider enrollment application that the
Medicare contractor is able to process to approval. 73 Fed. Reg. 69,726, 69,769 (Nov.
19, 2008); see also Caroline Lott Douglas, PA, DAB CR2406, at 5-7 (2011); Rizwan
Sadiq, M.D., DAB CR2401, at 5 (2011). Because First Coast received a complete,
approvable application from Petitioner on June 6, 2012, the effective date for Petitioner’s
enrollment is June 6, 2012.

3. First Coast’s reference to an “effective billing date” means the date
Petitioner’s retrospective billing period begins.

Under the regulations set forth below, CMS may permit limited retrospective billing if
a practitioner meets all program requirements.

Physicians, nonphysician practitioners and physician and nonphysician
practitioner organizations may retrospectively bill for services when a
physician or nonphysician practitioner or a physician or a nonphysician
practitioner organization have met all program requirements, including
State licensure requirements, and services were provided at the enrolled
practice location for up to—

(1) 30 days prior to their effective date if circumstances precluded
enrollment in advance of providing services to Medicare beneficiaries, or

(2) 90 days [in certain emergencies not applicable to this case.]
42 CFR. § 424.521(a).

In both of its determinations, First Coast erroneously characterized the beginning of the
retrospective billing period to be the effective date. CMS Exs. 2, at 1; 4, at 2. This
conclusion is based on reading First Coasts’ determinations consistently with the
regulation quoted above. See Jorge M. Ballesteros, DAB CR2067, at 2 (2010) (“CMS
apparently sets enrollment effective dates 30 days prior to the date of application, which
is what the Medicare contractor did here.”). Therefore, I interpret First Coast’s
determination to mean that the “effective billing date” is the beginning of the
retrospective billing period. Sadig, DAB CR2401, at 5-6.

Accordingly, in the present matter, the earliest effective date for retrospective billing
privileges that Petitioner could be granted is 30 days prior to June 6, 2012. Because First
Coast originally found Petitioner’s effective date to be June 14, 2012, First Coast
determined the retrospective billing to be 30 days prior to June 14, 2012, which is May
15, 2012. However, because CMS has discretion to set retrospective billing privileges for
any length of time not exceeding 30 days, I must conclude that May 15, 2012, is still a
permissible date for Petitioner’s retrospective billing privileges to begin. As noted above,
CMS has the authority to modify this date and CMS has indicated that it is in the process
of making an adjustment to the retrospective billing date. CMS Br. at 3 n.2.

4. Equitable estoppel cannot be applied against CMS.

Petitioner disputes the effective date of his reassignment (now determined to be June 6,
2012) and his retrospective billing date (May 15, 2012, barring CMS action to change it).
CMS Exs. 3, 4, 5; P. OSC Response. Petitioner argues that he is entitled to an earlier
effective date due to erroneous advice he received from First Coast personnel.
Specifically, he argues that a First Coast employee told him not to file his Form CMS-
855R until after JMH’s Form CMS-855B was approved. Petitioner argues that he should
have received the same effective date as JMH, which is January 11, 2012. CMS Exs. 3,
4, 5; P. OSC Response.

Because Petitioner did not allege any affirmative misconduct by First Coast personnel,
Petitioner’s arguments amount to a claim of equitable estoppel for which I am unable to
grant any relief. It is well-established that: (1) estoppel cannot be the basis to require
payment of funds from the federal fisc; (2) estoppel cannot lie against the government, if
at all, absent a showing of affirmative misconduct, such as fraud; and (3) I am not
authorized to order payment contrary to law based on equitable grounds. It is well settled
that those who deal with the government are expected to know the law and may not rely
on the conduct of government agents contrary to law. See, e.g., Office of Personnel
Mgmt. v. Richmond, 496 U.S. 414 (1990); Heckler v. Cmty. Health Servs. of Crawford
County, Inc., 467 U.S. 51 (1984); U.S. Ultrasound, DAB No. 2303, at 8 (2010);
Oklahoma Heart Hosp., DAB No. 2183, at 16 (2008); Wade Pediatrics, DAB No. 2153,
at 22 n.9 (2008), aff'd, 567 F.3d 1202 (10th Cir. 2009). Therefore, Petitioner’s equitable
estoppel argument must be rejected.
III. Conclusion

For the reasons explained above, I modify First Coast’s determination and find that the
effective date of Petitioner’s enrollment in the Medicare program is June 6, 2012.
However, until CMS modifies Petitioner’s retrospective billing date, Petitioner’s
retrospective billing date remains May 15, 2012.

/s/
Scott Anderson
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Taos Living Center,

(CCN: 32-5101),

Petitioner,

v.

Centers for Medicare & Medicaid Services.
Docket No. C-12-8
Decision No. CR2867

Date: July 23, 2013

DECISION

I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) that
Taos Living Center (Petitioner or the facility) was not in substantial compliance with
Medicare program participation requirements. I also sustain as reasonable CMS’s
imposition of two per instance civil money penalties (PICMPs), one in the amount of
$4,500 and one in the amount of $5,000, and CMS’s imposition of denial of payment for
new admissions (DPNA) for the period of June 3 through June 9, 2011.

I. Background

The Social Security Act (Act) sets forth long-term care facility requirements for
participation in the Medicare and Medicaid programs and authorizes the Secretary of the
U.S. Department of Health and Human Services (Secretary) to promulgate regulations
implementing those statutory provisions. Act §§ 1819 (42 U.S.C.§ 1395i-3), 1919 (42
U.S.C. § 1396r); see 42 C.F.R. Part 483 (implementing regulations). To participate in the
Medicare program, a skilled 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 Secretary contracts with state survey agencies to conduct periodic surveys to
determine whether skilled nursing facilities are in substantial compliance. Act § 1864(a)
(42 U.S.C. § 1395aa); 42 C.F.R. § 488.20. A facility must be surveyed once every twelve
months, and more often if necessary, to ensure the correction of deficiencies. Act

§ 1819(g)(2)(A) (42 U.S.C. § 1395i-3); 42 C.F.R. §§ 488.20(a), 488.308.

Petitioner is a long-term care facility located in Taos, New Mexico. Its appeal involves
two surveys conducted by the New Mexico Department of Health, Health Facility
Licensing and Certification Bureau (the state agency). After the first survey, ending
April 7, 2011, the state agency found four deficiencies, three of which were at a scope
and severity level of “J,” indicating an isolated incidence of immediate jeopardy. The
state agency then performed a revisit/complaint survey, which ended June 1, 2011.’ The
state agency found continued noncompliance (three deficiencies) two of which were at
the immediate jeopardy level. On September 8, 2011, CMS notified Petitioner that it had
achieved substantial compliance as of June 10, 2011. In addition, CMS notified
Petitioner that it was revising the previously imposed remedies and only the following
remedies were being imposed: a PICMP of $4,500 for the April survey with respect to
Tag F323 (accident prevention and adequate supervision) — 42 C.F.R.

§ 483.25(h); a PICMP of $5,000 for the June survey with respect to Tag F314 (prevention
of pressure sores) — 42 C.F.R. § 483.25(c); and a DPNA for the period of June 3 through
June 9, 2011.7 CMS Br. at 2-3.

' Petitioner’s hearing request with respect to the April survey was consolidated with its
hearing request for the June survey by my Acknowledgment and Consolidation Order
dated October 4, 2011.

> Twill not review CMS’s immediate jeopardy scope and severity finding here. An
Administrative Law Judge may review CMS’s scope and severity findings (which
include a finding of immediate jeopardy) only if: (1) a successful challenge would affect
the range of the CMP; or (2) CMS has made a finding of substandard quality of care that
results in the loss of approval of a facility’s nurse aide training program. Here the
penalties imposed are PICMPs for which the regulations provide only one range ($1,000
to $10,000) so the level of noncompliance does not affect the range of the CMP. 42
C.F.R. § 488.438(a)(2). Additionally, CMS’s scope and severity finding does not affect
approval of a nurse aide training program because the facility has been assessed a CMP
of $5,000 or more which precludes state agency approval of a nurse aide training
program. Act § 1819(f)(2)(B) (42 U.S.C. § 1395i-3); 42 C.F.R. § 483.151(b)(2)(iv).
Petitioner timely requested a hearing, and the case was assigned to me for hearing and
decision. I convened a prehearing conference with the parties on February 1, 2012. In
that conference I articulated the issues that I would be deciding, I admitted to the record
without objection CMS exhibits (Exs.) 1-17 and Petitioner’s exhibits (P. Exs.) 1-3, and
the parties indicated which witnesses they wished to cross-examine at a video hearing.

I convened a video hearing on May 30, 2012, for the purpose of cross examination and
redirect examination of CMS’s two witnesses. I also admitted into the record without
objection an article entitled, “Dysphagia Management: Using Thickened Liquids,” as P.
Ex. 4. The parties filed pre-hearing briefs (CMS PH Br. and P. PH Br.), post-hearing
briefs (CMS Br. and P. Br.), and post-hearing reply briefs (CMS Reply and P. Reply).

IL. Analysis
A. Issues
The issues are whether Petitioner failed to comply substantially with the requirements of:

1. 42 C.F.R. § 483.25(h) (Tag F323) relating to accident prevention and
adequate supervision involving Resident 10;

2. 42 C.F.R. § 483.25(c) (Tag F314) relating to the prevention of pressure sores
as cited in the June survey; and

3. If I find Petitioner was not in substantial compliance, are the penalties CMS
imposed reasonable: the $4,500 and $5,000 PICMPs and a DPNA for the period of
June 3 through June 9, 2011.

B. Findings of Fact and Conclusions of Law

1. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(h)
because it did not reasonably reduce the foreseeable risk of aspiration for
Resident 10 when its staff did not provide him properly thickened liquids in
accordance with his care plan.

Program Requirements. The introductory language in section 483.25 states: “Each
resident must receive, and the facility must provide, the necessary care and services to
attain or maintain the highest practicable physical, mental, and psychosocial well-being,
in accordance with the comprehensive assessment and plan of care.”

Subsection (h) of 483.25 specifies:
Accidents. The facility must ensure that —

(1) The resident environment remains as free of accident hazards as is
possible; and

(2) Each resident receives adequate supervision and assistance devices to prevent
accidents.

The Board has held that subsection 483.25(h)(1) requires that a facility address
foreseeable risks of harm from accidents “by identifying and removing hazards, where
possible, or where the hazard is unavoidable because of other resident needs, managing
the hazard by reducing the risk of accident to the extent possible.” Maine Veterans’
Home - Scarborough, DAB No. 1975, at 10 (2005) (explaining the inherent standard of
care in section 483.25(h)(1)). With regard to subsection 483.25(h)(2), the Board requires
that a facility take “‘all reasonable steps to ensure that a resident receives supervision and
assistance devices that meet his or her assessed needs and mitigate foreseeable risks of
harm from accidents.” Briarwood Nursing Ctr., DAB No. 2115, at 11 (2007), (citing
Woodstock Care Ctr., DAB No. 1726 (2000) (facility must take “‘all reasonable
precautions against residents’ accidents”), aff'd, Woodstock Care Ctr. v. Thompson, 363
F.3d 583, 589 (6th Cir. 2003)). Further, the Board has also held that accident precautions
contained in a resident's plan of care represent a facility’s judgment about what measures
are necessary to keep the resident safe, and failure to implement such precautions
supports a conclusion that a facility did not meet its obligation under section 483.25(h)(2)
to provide adequate supervision. St. Catherine's Care Ctr. of Findlay, Inc., DAB No.
1964, at 13 n.9 (2005); Cedar Lake Nursing Home, DAB No. 2288, at 6-11 (2009), aff'd,
Cedar Lake Nursing Home v. U.S. Dep't of Health & Human Servs., 619 F.3d 453 (5th
Cir. 2010).

Here, Resident 10 was diagnosed with Parkinson’s disease and suffered from dysphagia,
i.e., swallowing difficulties. CMS Ex. 2 at 3, 4, 7, and 13. He also had a history of
aspiration pneumonia. CMS Ex. 16 at 7; CMS Ex. | at 9. Resident 10’s plan of care
indicated he was at risk for aspirating, and he was prescribed a diet with mechanically,
soft textured foods and nectar thickened liquids, including thickened water. CMS Ex. 3
at 5; CMS Ex. 2 at 2, 3, 4, 7, and 8. I am aware of no evidence that allowed for a
reduction of the thickness of Resident 10’s liquids to accommodate Resident 10’s taste
preferences.

A nurse surveyor observed two instances on March 28, 2011, when Petitioner’s staff gave
Resident 10 what she believed were improperly thickened liquids.
First, the Statement of Deficiencies (SOD) reported the surveyor observed, at 12:45 p.m.,
a certified nursing assistant (CNA 2) preparing and serving Resident 10 drinking water
that the surveyor determined was not properly thickened. CMS Ex. 1 at 4. The SOD
reported that the surveyor observed Resident 10 cough during his meal. CMS Ex. | at 4.
The SOD reported the CNA admitted to the surveyor she did not properly follow the
directions provided with the resident’s thickening agent and that she prepared it less
thick, with one and a half scoops, because Resident 10 liked it that way. CMS Ex. | at 4.
The SOD reported that the duty nurse (RN1) confirmed that CNA 2 used a twelve-ounce
cup and that two large scoops should be used because the cup was not completely full.
The SOD also reported the Speech Therapist stated that two large scoops were needed to
obtain nectar consistency. CMS Ex. | at 8-9.

Then, at 5:05 pm, the state surveyor observed another CNA (CNA 3) providing Resident
10 with coffee that she determined had not been properly thickened. CMS Ex. 1 at 4-5,
9; CMS Ex. 2 at 4. The SOD reports that when the surveyor questioned the Speech
Therapist, the Speech Therapist confirmed that the coffee was not a nectar-like thickness
and was too thin. CMS Ex. | at 9, P. Reply at 3.

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.”
Evergreene Nursing Care Ctr., DAB No. 2069, at 7 (2007); Batavia Nursing &
Convalescent Ctr., DAB No. 1904 (2004), aff'd, Batavia Nursing& Convalescent Ctr. v.
Thompson, 129 F. App’x 181 (6th Cir. 2005). CMS relies on the SOD to make its prima
facie case of a deficiency here. See Guardian Health Care Ctr., DAB No. 1943, at 15
(2004) (holding that a prima facie showing of noncompliance may be based on the SOD,
if the factual findings and allegations it contains are specific, undisputed, and not
inherently unreliable).

Petitioner did not dispute the specific and reliable facts that surveyors reported in the
SOD, so CMS met its burden to present a prima facie case that Petitioner failed to
provide Resident 10 with requirements from his care plan to help prevent risk of
aspiration from liquids. Petitioner, therefore, bears the burden of persuasion — namely, to
demonstrate by a preponderance of the evidence that the facility was in fact in substantial
compliance with section 483.25(h)(2). Evergreene, DAB No. 2069, at 7.

Petitioner argues that the nurse surveyor concluded the observed liquids were not nectar
consistency without considering how big the cup was, how much time had expired since
the mixing, or the temperature of the liquids. P. PH. Br. at 4. However, Petitioner has
not provided any evidence showing staff raised these concerns with the nurse surveyor at
the time of the cited deficiency. Instead, the uncontroverted evidence shows CNA 2
explained to the nurse surveyor that she did not follow the thickening directions and
prepared the water less thick because Resident 10 liked it that way, even though I saw no
evidence that Resident 10’s assessments or plans included any provision for liquids at
less than a nectar thick consistency. Also it is uncontroverted that the facility’s speech
therapist opined that the coffee CNA 3 prepared for Resident 10 was “too thin.” To now
argue that the liquids may have been of the required consistency due to the factors of cup
size, passage of time, or temperature is a post hoc rationalization, which I do not find
persuasive. Petitioner’s cross-examination of the surveyors did not discredit the SOD
reports. Further, Petitioner did not come forward with its own witness testimony to help
prove other viscosity factors caused the staff to stray from the thickener directions for
Resident 10’s drinks on March 28, 2011. Therefore I do not find that Petitioner met its
burden of persuasion.

The testimony of CMS’s expert witness and federal nurse surveyor not only helps show
that the deficiency had the requisite potential for more than minimal harm, but it also had
the potential for serious harm. She credibly testified about the importance of thickened
iquids for patients with dysphagia or swallowing difficulties because these patients may
choke or cough on normal, thin liquids. CMS Br. at 5 n.4; CMS Ex. 16; Tr. 14-16.
Generally, with swallowing difficulties, muscles may not react fast enough to swallow
properly and some of the liquid may go into residents’ airways leading to the lungs.
CMS Ex. 16 at 7; CMS Br. at 5 n.4. The introduction of fluid into the lungs in this
manner could cause aspiration pneumonia in addition to airway obstruction,
inflammation of the lung, acute respiratory distress syndrome, bronchitis, interstitial
pneumonitis, bronchiectasis, fibrosis, and asthma-like symptoms. Jd. She indicated that
the viscosity of a liquid therefore is very important because a patient with dysphagia can
choke on thinner liquids. Tr. 14. She also credibly testified that the thickeners used for
this purpose have very specific instructions stating the manufacturer-recommended
amounts to use, the amount of time to stir, and what the consistency of the thickened
iquid should be on observation before it is given to the patient. Tr. 15.

The federal nurse surveyor further testified that if a resident requests a thinner
consistency of liquid than what the physician ordered, it is the responsibility of the
facility to contact the physician and notify the physician of the resident’s request for a
thinner consistency liquid and for the physician to determine, with the resident, if a
thinner liquid is appropriate. Tr. 15. There is no indication from the record that
Petitioner did this; instead, the record indicates CNA 2 adjusted the viscosity without
consultation with the Speech Therapist, the RN, or the resident’s physician. CMS Br. at
12; CMS Ex. | at 5-10.

I find it was a foreseeable, and undisputed, risk that Resident 10 could easily aspirate, and
Petitioner planned accordingly by requiring that Resident 10 only receive properly
thickened beverages in his plan of care. I find the evidence shows that Petitioner’s staff
did not properly thicken the beverages it provided to Resident 10. Therefore it did not
take all reasonable steps to prevent the risk of him aspirating, which justifies CMS’s
determination that Petitioner was not in substantial compliance with Medicare
requirements to prevent accidents and provide adequate supervision.

Petitioner also argues that Resident 10 had been receiving thickened liquids since at least
October 18, 2010, with no indication that he experienced any incidents of aspiration at
the facility. P. PH. Br. at 5. Further, Petitioner argues that Resident 10 received total
assistance and supervision from Petitioner’s staff for all meals and beverages he
consumed. Jd. Although I may consider a facility’s history of noncompliance when
determining whether the penalty CMS imposed is reasonable, an absence of past
aspiration incidents involving Resident 10 would not excuse the deficiency itself.
Further, I do not find that a resident should have had to actually aspirate, even while
supervised, before a deficiency may be upheld for improperly thickened liquids.

2. Petitioner was not in compliance with 42 C.F.R. § 483.25(c) relating to the
prevention of pressure sores.

Program Requirements. The quality of care requirement specific to pressure sore
prevention and treatment provides:

Pressure sores. Based on the comprehensive assessment of a resident, the
facility must ensure that - (1) A resident who enters the facility without
pressure sores does not develop pressure sores unless the individual's
clinical condition demonstrates that they were unavoidable; and (2) A
resident having pressure sores receives necessary treatment and services to
promote healing, prevent infection and prevent new sores from developing.

42 C.F.R. § 483.25(c). The Board has well-established the application of this pressure
sore regulation. Citing the Secretary’s refusal to replace the word “ensure” with less
demanding language, the Board has held that a facility “should go beyond merely what
seems reasonable to, instead, always furnish what is necessary to prevent new sores
unless clinically unavoidable, and to treat existing ones as needed.” Koester Pavilion,
DAB No. 1750, at 32 (2000) (citing 56 Fed. Reg. 48,826, at 48,850 (Sept. 26, 1991)); see

also Clermont Nursing & Convalescent Ctr., DAB No. 1923, at 9-10 (2004)(citing
Koester and rejecting provider’s argument that a “standard of necessity appears nowhere
in the regulation”), aff'd, Clermont Nursing & Convalescent Ctr. v. Leavitt, 142 F. App’x
900 (6th Cir. 2005).

a. CMS established that Resident 1 developed pressure sores in
Petitioner’s facility from March 24, 2011 — April 19, 2011.

In Koester Pavilion and Clermont, the Board held that a prima facie case of
noncompliance exists when the evidence establishes that a nursing home resident having
no pressure sores on admission develops a pressure sore in the facility, and the burden
then shifts to the facility to establish that the pressure sore was clinically unavoidable.
Koester Pavilion, DAB No. 1750, at 34; Clermont Nursing & Convalescent Ctr., DAB
No. 1923, at 9; see also Woodland Vill. Nursing Ctr., DAB No. 2172, at 13 (2008)
(finding evidence that resident developed a pressure sore while under a facility’s care is
enough to show a deficiency in the absence of clinical evidence from the facility proving
such negative outcomes to have been clinically unavoidable), aff’d, Woodland Vill.
Nursing Ctr. v. U.S. Dep’t of Health & Human Servs., 239 F. App’x 80 (5th Cir. 2007).

Here, Resident 1, a developmentally-delayed 59 year-old male, was admitted to Taos
Living on March 24, 2011, with diagnoses of recurrent cellulitis, a bacterial skin infection
to the right leg, poorly controlled diabetes, chronic kidney disease, hypertension, morbid
obesity, and anemia. It is undisputed that he had no documented pressure sores upon
admittance. CMS Ex. 7 at 27; CMS Ex. 10 at 1-2,9, 6, 67.

Resident 1’s skin roster for the period March 24-April 19, 2011, documented that CNA 1
charted new skin issues for this resident on March 27, April 11, April 16, and April 17,
2011. CMS Ex. 10 at 61-62. CNA 11 also documented a new skin concern on April 17,
2011. Jd. Petitioner’s wound care logs however do not indicate that Resident 1 ever
received wound care. CMS Ex. 7 at 31; Tr. 23.

Approximately 26 days after his admission, Petitioner transferred Resident | to a hospital
emergency room (ER) on April 19, 2011, for severe abdominal pain. Resident 1’s skin
condition upon admission to the hospital from Petitioner’s facility was so disturbing that
a hospital case manager and the hospital Wound Care Specialist had to speak with ER
staff and calm them down because Resident 1 was in such poor shape. CMS Ex. 7 at 11;
CMS Ex. 14, at 2,4. The case manager consequently filed a report of neglect with the
state agency. Tr. 28. The state agency then initiated a complaint survey of Petitioner on
May 11, 2011. CMS Ex. 17 at 2.

Upon his ER admission, a hospital Physician Assistant documented 18 wounds including
12 pressure ulcers on Resident 1’s body. CMS Ex. 7 at 29-30; CMS Ex. 11 at 76. That
same day, the Director of Day Medicine from wound care came down to the ER to
consult and take measurements of the decubitis ulcers that the Physician Assistant, the
paramedic, and the ER Nurse observed. CMS Ex. 7 at 30. The doctor then completed a
multi-system evaluation of Resident 1, which documented decubiti ulcers, candiasis in
the groin, acute renal failure, dehydration, hyperkalemiam, and leukocytosis. CMS Ex. 7
at 30; CMS Ex. 11.

The hospital’s wound care report, dated April 20, 2011, noted Resident | presented to the
ER with 18 wounds including bilateral necrotic heel ulcers, multiple buttock wounds,
groin wounds, sacral ulcers, right elbow eschar, and “left posterior upper thigh X2.”
CMS Ex. 11 at 82. Pictures were taken of each wound with a wound measuring guide.
CMS Ex. 11 at 77-81. The pictures of the sores on Resident 1’s heels show deep wounds
the circumference of baseballs with black tissue throughout. CMS Ex. 11 at 78. On
April 26, 2011, the hospital had to transfer Resident 1 to another hospital for specialty
wound care of multiple necrotic ulcers. CMS Ex. 11 at 95-101. The doctor at this
facility reported to a surveyor that about a third of Resident 1’s 18 wounds were necrotic,
and, while Resident 1 might have picked at some wounds, his heels and toes were not
new wounds and were clearly pressure sores. CMS Ex. 7 at 31-32. The left heel pressure
sore measured 6.5 x 5.0 cm and was noted as 100 % necrotic; the right heel sore
measured 4.5 x 4.0 cm and also was noted as 100% necrotic. CMS Ex. 7 at 32; CMS Ex.
11 at 78, 90 and 92.

b. Petitioner did not meet its burden to establish that Resident 1’s
multiple pressure sores were clinically unavoidable because it did not
prove that it properly assessed, monitored, and treated his skin conditions.

A nursing home can overcome a prima facie case of noncompliance only by showing that
it provided all the care and services needed to prevent pressure sores but that the pressure
sores developed anyway because they were clinically unavoidable. Koester Pavilion,
DAB No. 1750, at 34; Clermont, DAB No. 1923, at 9. Clinically unavoidable in this
context means “not just unsurprising given the clinical condition of the resident, but
incapable of prevention despite appropriate measures taken in light of the clinical risks.”
Harmony Court, DAB No. 1968, at 11 (2005), aff'd, Harmony Court v. Leavitt, 188 F.
App’x 438 (6th Cir. 2006). A facility “cannot meet its burden of proof on the issue of
whether a pressure sore is unavoidable merely by establishing that the resident’s clinical
condition heightens the risk that pressure sores will develop.” Jd. (quoting Ivy Woods
Health Care & Rehab. Ctr., DAB No. 1933, at 9 (2004), aff'd, Ivy Woods Health Care &
Rehab. Ctr. v. Thompson, 156 F. App’x 775 (6th Cir. 2005)).

Here, Petitioner did not show it provided the requisite preventative care because it did not
properly assess, monitor, and treat Resident 1’s pressure sores. The scant and
10

inconsistent documentation showing what Petitioner did do to treat Resident 1’s skin
conditions falls far short of Petitioner’s burden to prove Resident 1 developed pressure
sores that were clinically unavoidable.

Early on, there are questions about the appropriateness of Petitioner’s assessments.
CMS’s expert credibly opined that Resident 1 should have been initially assessed at high
risk for pressure ulcers considering he was frequently incontinent of urine and feces, had
impaired functional mobility, and poorly controlled Diabetes. CMS Ex. 16 at 8. Upon
admission, however, Resident 1’s Braden Scale skin assessment from the facility, dated
March 24, 2011, indicated he was at low risk for pressure sores. CMS Ex. 10 at 4.
Similarly, CMS’s expert reports his Minimum Data Set assessment from the facility,
dated April 2, 2011, indicated he was not at risk for pressure ulcers. CMS Ex. 16 at 8.
However, his Interim Plan of Care indicates that as of March 26, 2011, Resident 1 was
considered at risk for skin breakdown, and he should be repositioned while in bed. CMS
Ex. 10 at 37. Also his Care Plan Conference Summary, dated April 6, 2011, stated that
Resident 1 was at risk for pressure sore development. CMS Ex. 10 at 38. Regardless of
the inconsistent assessments, the facility was required to perform skin checks on Resident
1 three times per day throughout his stay and document them on the facility’s Skin
Roster. CMS Ex. 10, p. 61; P. PH. Br. at 7.

Petitioner’s clinical records show four “Nursing to Therapy Referral” forms for Resident
1 during the period of April 11 through April 18, 2011. CMS Ex. 10 at 45-48. Although
the facility also indicated a skin issue for Resident 1 on March 27, 2011, I saw no
corresponding “Nursing to Therapy Referral” form to document any care or monitoring
of the issue. In her scant written declaration of direct testimony, and despite Petitioner’s
eavy burden of persuasion here, the Wound Care Specialist only mentions that she saw
Resident 1 on April 18, 2011, after receiving two referral forms regarding his open areas
to the inner and gluteal folds. P. Ex. 1. She states she inspected this area on him but did
not discover any wound that appeared to be a pressure wound. Jd. She concluded that
the redness and irritation she observed was caused by excoriation and candidiasis. Jd.
Consequently, she did not provide Resident 1 with wound care. CMS Ex. 10 at 45-48;
CMS. Ex. 4; CMS Ex. 7 at 31.

A note the Wound Care Specialist wrote on April 18, 2011 refers to a nursing therapy
referral form for a red, soft area on Resident 1’s right outer knee from his leg brace. The
note states she inspected the area and because the brace is only worn when walking with
“restorative rehab,” she was unable to determine if the area is from the brace. The note
says she will continue to monitor and make needed adjustments. She also indicates that
the physician will be in to see Resident | the next day and she will have him look at the
area “as well as the peri-area that has also been reported to have open areas that the
calazime is not helping.” CMS Ex. 10 at 25. She also entered another note at 2:59 p.m.
11

that same day indicating that she received two Nursing to Therapy Referral Forms
regarding open areas to inner thigh and gluteal folds. She stated she “inspected the area
when patient in bed and irritation is from brief.” She suggests “switching to pull ups to
see if this will make contact in a different area, encourage time in bed between meals as
sitting all day in WC [wheelchair] encourages brief to bunch up in these areas. Dr. [W]
to see patient tomorrow.” CMS Ex. 10 at 25.

Despite the Wound Care Specialist’s direct testimony only mentioning the time she saw
Resident 1 on April 18, 2011, there is an interdisciplinary note dated April 12, 2011 that
she drafted stating, “Nursing to Therapy Referral Form received 4/11/11 regarding
patient having open areas to buttocks and left front leg. Checked resident to find
excoriation to buttock and rubbing irritation to left inner thigh, recommend calazime
ointment to all areas with brief change as well as a larger size brief as patient has a large
abdominal panus and spends all of the day sitting in his wheelchair increasing friction to
this area.” CMS Ex. 10 at 28, 45.

Petitioner also submitted a declaration from one of its nurses, who documented, on the
date of Resident 1’s transfer to the hospital for abdominal pain, April 19, 2011, that
Resident 1 had an open area on his groin and “excoriated bottom with calzamine
ointment applied.” CMS Ex. 10 at 25; P. Ex. 2. He also noted observing an open area
on Resident 1’s left heel that he treated with triple antibiotic cream and a telfa pad. P.
Ex. 2. The nurse states that he does not recollect whether he checked the resident’s right
eel or whether there was a pressure wound on the right heel, but it was his usual practice
to do so if he had discovered one on the other heel. P. Ex. 2.

Petitioner’s wound care logs do not indicate that Resident 1 ever received wound care.
CMS Ex. 7 at 31; Tr. 23. However, the lead surveyor credibly testified that she would
ave expected Resident 1’s wounds to be documented on a wound log. Tr. 23. She
stated that the standard of practice should have been for the Wound Care Specialist to
view all areas of Resident 1’s skin and to make specific notations as to an accurate
assessment, which would include specific measurements of each wound—the length, the
width, the depth of the wound— whether there is any drainage present, the color, whether
there is any odor present which could indicate an infection, the location of each wound,
and the type of wound. Tr. 23. She further testified that the wound log and clinical
records should have specifically noted when the physician is notified and a request is
made for treatment. The log should also note if the wound is improving after treatment
for a specific period of time, and if not, whether the physician has again been contacted
and a new treatment obtained. Tr. 23-24.

The lead surveyor also testified that the standard of practice is for all wounds whether
they are a pressure ulcer, a deep-tissue injury, a stasis ulcer or a surgical wound, to be
12

included on the wound log and monitored. Tr. 24-25. The purpose of the wound log is to
have ongoing monitoring and consistent measurement and assessment so as to determine
if a wound is healing and progressing with treatment as prescribed and to have a method
to determine whether the treatment prescribed for the wound is effective. Tr. 25.
Typically, if staff finds a pressure ulcer, staff would indicate that on the wound log and
stage the ulcer on the log.*

The lead surveyor indicated that the documentation Petitioner provided to her from
Resident 1’s clinical records, which were the notes and referrals from nursing to the
Wound Care Specialist, noted Resident 1 had open areas to the groin and observations of
oozing fluid. Tr. 26. However, she credibly opined there were no assessments showing a
nurse or the Wound Care Specialist actually assessing all the areas and describing the
wounds with appropriate information such as specific measurement of the length, width,
depth of the wound, whether the skin was intact or open, how many layers of the skin
were involved, and whether there was any odor. Tr. 23-26.

Although Petitioner’s nursing staff noted skin issues with Resident | as early as March 27
and up through April 19, not once during this time did the Wound Care Specialist enter
Resident 1’s wounds on the facility’s wound log after receiving referrals. Without such
entries, the facility was not ensuring an accurate assessment of the size, depth, character
and stage of his wounds, and no there were no reliable means to determine what course of
treatment had been prescribed and whether it was effective. When Petitioner’s staff
transferred Resident | to the hospital, it also did not conduct a facility transport record
documenting his skin integrity. CMS Ex. 14 at 6. Clearly, Petitioner’s overal
documentation does not come close to matching, let alone explaining, the serious state of
Resident 1’s skin conditions that were fully documented upon his arrival at the hospital.

Petitioner’s arguments in response to CMS’s allegations of a lack of care documentation
are not persuasive. P. PH. Br. 7-12. First, Petitioner contends CMS has provided no
evidence that the numerous wounds “in the area beneath where he [Resident 1] wore a
brief” were pressure wounds. Jd. at 7. Instead, Petitioner argues that Resident 1’s
wounds “were more likely the result of excoriation and candidiasis resulting from
Resident 1’s non-compliance with toileting, brief changes, and bathing. Jd. However,
even after allegedly checking Resident 10 three times per day, Petitioner still did not

> The lead surveyor further explained that stage 1 is when the skin is still intact but
reddened and not penetrable on touch. Ifthe skin is open and it is just a superficial layer
of tissue damage, then it would be considered a stage 2 wound. Wounds or pressure
ulcers are staged up to stage 4, which means the wound goes through all layers of the
skin, into the muscle and to the bone. Tr. 25.
13

sufficiently document and monitor these skin issues on its skin roster or wound log.
CMS Ex. 10 at 61; P. Br. at 7. Therefore, there is no compelling evidence that Petitioner
was carefully monitoring the development any kind of skin condition on Resident 10, let
alone evidence that it thoughtfully differentiated less serious skin conditions from
pressure sores.

Petitioner also contends that any pressure wounds in the area Resident 1 wore a brief
“could well have developed between the time that Resident 1 was discharged from Taos
Living Center and the time his wounds were first noted by the hospital” when Resident 1
was transferred to the ER on April 19, 2011. P. PH. Br. at 7. This explanation is
inconsistent with other credible evidence in the record because Petitioner’s own staff
identified skin issues for Resident 1 in this same area on April 11, April 15, and April 17,
2011. CMS Ex. 10 at 45-48; CMS Ex. 10 at 61.

Petitioner argues that Resident 1’s primary physician examined him on April 12, 2011
and that it would be highly unlikely that any examination of Resident 1’s legs and groin
would have failed to reveal the wounds to his heels and sacrum. P. PH. Br. at 8.
However, I am not persuaded by this explanation considering the nurse surveyor reported
interviews in the SOD with Resident 1’s treating physicians that appear inconsistent with
the proposition that Resident 1 received a comprehensive skin examination. She reported

that treating MD 2 in fact
aware of Resident 1’s ear

not answer specific questi

admission to the hospital
treating MD 1. Id. MD

did not get to see his skin.
there was no report about

With regard to Resident

confirmed Resident 1 was mostly immobile and MD 2 was

ly skin breakdown. CMS Ex. 7 at 37. MD 2 reportedly could
ions when asked about Resident | having 18 open areas upon
rom Petitioner’s facility. Jd. MD 2 referred questions back to
reportedly stated that when Resident 1 went to his office, he
he was not aware of any open areas or pressure ulcers, and

is feet. Id.

>

s wounds on both heels, Petitioner states its nurse first noted

the pressure wound on Resident 1’s left heel on the morning of April 19, 2011, prior to

Resident 1’s discharge to
contends that, because of
pain in his bed. This writ

the ER. P. PH. Br. at 8, 9, 12; CMS Ex. 10 at 25. Petitioner
is abdominal pain, Resident 1 was sometimes “writhing in
ing action undoubtedly caused the pressure wound on his left

heel noted by nurse [J.C.

.” P. PH Br. at 8. The pictures of these apparently necrotic

wounds contradict this suspect explanation. CMS Ex. 11 at 78-79. In fact, the Hospital
Physician Director of Day Medicine confirmed that the wounds on Resident 1’s heels and
toes were not new wounds, but rather, they were old and necrotic. CMS Ex. 7 at 31, 32.
14

He opined that these wounds were clearly pressure wounds. CMS Ex. 7 at 32. It is
highly unlikely then that black, necrotic wounds the circumference of baseballs would
appear in, as Petitioner’s nurse suggests, in a matter of hours as a result of Resident 1
“writhing” in pain.

Petitioner’s Wound Care Specialist also references a one-page article, without any
detailed explanation with regard to its application to Resident 1, and attempts to explain
“pressure wounds can develop very quickly between the first hour and 4 to 6 hours after
sustained loading.” P. Ex. 1 at 2. In the face of the hospital’s documentation of a
multitude of wounds on Resident 1, I do not find her vague explanation persuasive at all
— there is no effort to describe to which of his 12 pressure wounds she may have been
referring, and it is incredible to me that she would be referring to all 12 pressure wounds.

I do not find the facility has shown, by a preponderance of the evidence, that it provided
the necessary care to ensure Resident 1’s pressure wounds were clinically unavoidable.
Twenty-six days passed from the point where it is undisputed that Resident 1 had no
pressure sores to where he presented to a hospital ER with 18 wounds including 12
pressure sores, several with necrosis. The ultimate burden was on Petitioner to prove it
properly assessed and treated Resident 1’s pressure sores, but the evidence before me
does not fully explain Resident 1’s desperate condition upon transfer to the hospital ER, a
transfer which Petitioner surprisingly attributes solely to abdominal pain, and not at all
for his 18 wounds.

Petitioner has not explained why it did not consistently assess Resident | as a risk for
pressure sores during the relevant period. Although there is some documentation of skin
issues for Resident 1, Petitioner also did not document proper care or monitoring for
them and excluded all of Resident 1’s skin conditions from its wound log. Petitioner
never even documented one of Resident 1’s necrotic heel wounds (the other one was
documented the day before his ER transfer) and unpersuasively argues it occurred during
the transfer process. It is quite a compelling contrast to see how the hospital ER treated
Resident 1 upon his admittance. The hospital assessed Resident 1’s wounds by
photographing, measuring, staging, and otherwise describing them in detail. The hospital
was then able to effectively monitor the treatment and healing it provided to Resident 1,
which included a referral to a facility that specialized in wound care.*

* Petitioner also argues that by the time the hospital referred Resident 1, the new hospital
only referenced three pressure ulcers versus the original twelve and suggests Resident 1
was not in such a deplorable state as CMS describes. P. PH. Br. at 11. Conversely, after
considering the hospital’s comprehensive wound documentation and care, I view any
healing while in the hospital as an indication of the avoidably of Resident 1’s sores while
at Petitioner’s facility. See Crestview Parke Care Ctr., DAB No. 2055, at 16-17 (2006)
15

The record is clear that, with regard to Petitioner’s insufficient assessment, monitoring,
and treatment of Resident 1’s pressure sores, Petitioner did not ensure that they were
clinically unavoidable. This deficiency alone supports the penalty CMS imposed without
the need to address the additional noncompliance CMS cited with respect to Resident 2.
See, e.g., The Residence at Salem Woods, DAB No. 2052, at 11 (2006) (stating that an
ALJ “may . . . find the CMP amount to be reasonable based on fewer deficiencies than
those upon which CMS relied to impose the penalty”).

3. The penalties CMS imposed, the $4,500 and $5,000 PICMPs and a DPNA for
the period of June 3 through June 9, 2011, are reasonable.

CMS must consider several factors when determining the amount of a CMP (factors an
ALJ considers de novo when evaluating the reasonableness of the CMP that CMS
imposed): (1) the facility’s history of noncompliance; (2) the facility’s financial
condition, i.e., its ability to pay the CMP; (3) the severity and scope of the
noncompliance, the “relationship of the one deficiency to other deficiencies resulting in
noncompliance,” and the facility’s prior history of noncompliance; and (4) the facility’s
degree of culpability. 42 C.F.R. §§ 488.438(f), 488.404(b), (c).

The Board has repeatedly held that “an ALJ or the Board properly presumes that CMS
considered the regulatory factors and that those factors support the amount imposed.”
See, e.g., Pinecrest Nursing & Rehab. Ctr., DAB No. 2446, at 23 (2012). Thus, CMS did
not need to present evidence regarding each regulatory factor. Instead, the burden was on
Petitioner ““‘to demonstrate, through argument and the submission of evidence addressing
the regulatory factors, that a reduction is necessary to make the CMP amount
reasonable.’” Jd. (quoting Oaks of Mid City Nursing & Rehab. Ctr., DAB No. 2375, at
26-27 (2011)).

Petitioner did not challenge the reasonableness of the PICMPs imposed in its appeal and
did not contest any of the factors set forth in the regulation that would affect my
consideration of the amount of the penalty. 42 C.F.R. § 488.438(f). While I do believe
that, especially with respect to the substantial noncompliance with 42 C.F.R. § 483.25(c),
CMS could have imposed a larger penalty, I will not substitute my discretion here for
CMS’s. I find as a whole, therefore, that the PICMPs imposed are more than reasonable
given the seriousness of the noncompliance and Petitioner’s culpability.

I also uphold CMS’s imposition of the DPNA for the period of June 3, 2011 through June
9, 2011. It is well settled that CMS has the right to impose one or more remedies

(explaining the fact that a new pressure sore healed quickly is further evidence that
facility could have avoided a pressure sore if it had provided proper care).
16

specified in 42 C.F.R. § 488.406 when it determines that the facility is not in substantial
compliance. 42 C.F.R. §§488.404, 488.406 and 488.408. The remedies that the Act and
regulations specify ‘with respect to a finding that a facility has not met an applicable
requirement,” include a DPNA, civil money penalties, and termination of the facility’s
agreement to participate in Medicare. Sections 1819(h)(2)(B) (42 U.S.C. § 1395i-
3(h)(2)(B)), 1919(h) (42 U.S.C. § 1396r(h)) of the Act; 42 C.F.R. §§ 488.400, 488.406,
488.408, 488.417. A DPNA may be imposed for any deficiency, except when a facility is
in substantial compliance. 42 C.F.R. §§ 488.408(d)(3), 488.417; Desert Hospital, DAB
No. 1623, at 5-6 n.4 (1997). A DPNA continues until either “(1) The facility has
achieved substantial compliance, as determined by CMS or the State based upon a revisit
or after an examination of credible written evidence that it can verify without an on-site
visit” or “(2) CMS or the State terminates the provided agreement.” 42 C.F.R.

§§ 488.454(a), 488.417(d); section 1819(h)(3) (42 U.S.C. § 1395i-3(h)(2)). Considering
Petitioner was not in substantial compliance with all participation requirements during
the revisit survey, and because Petitioner did not show that it abated its noncompliance
before June 10, 2011, a DPNA for this period was appropriate. CMS Ex. 8; CMS Br. at
23.

II. Conclusion

For the foregoing reasons, I conclude that Petitioner, Taos Living Center, was not in
substantial compliance with Medicare program participation requirements. I also sustain
as reasonable CMS’s imposition of two per instance civil money penalties, one in the
amount of $4,500 and one in the amount of $5,000, against Petitioner and CMS’s
imposition of a DPNA for the period of June 3 through June 9, 2011.

/s/
Joseph Grow
Administrative Law Judge