Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Buena Vista Care Center,
(CCN: 55-5394),

Petitioner,
v.
Centers for Medicare & Medicaid Services.
Docket No. C-10-918
Decision No. CR2518

Date: March 22, 2012

DECISION

Petitioner Buena Vista Care Center challenges the determination of the Centers for
Medicare & Medicaid Services (CMS) that it was not in substantial compliance with
program participation requirements. Petitioner also challenges CMS’s imposition of a
per instance civil money penalty (PICMP) of $7,100. For the reasons discussed below, I
sustain CMS’s determination and imposition of the $7,100 PICMP.

I. Background

Petitioner is a long-term care facility located in Santa Barbara, California. Petitioner
participates in the Medicare and Medicaid programs. The California Department of
Public Health (state agency) conducted a recertification survey of the facility on May 20,
2010, and a revisit survey on July 13, 2010. Based on the findings of the May 20, 2010
survey, Petitioner was found out of substantial compliance with 19 participation
requirements. The July 13, 2010 revisit found Petitioner back in substantial compliance.
By letters dated June18 and August 2, 2010, CMS notified Petitioner that it was imposing
the remedies of a denial of payment for new admissions (DPNA) effective July 3 through
13, 2010, and a $7,100 PICMP for a violation of 42 C.F.R. § 483.25(h), found on the
May 20, 2010 recertification survey statement of deficiencies (SOD) at Tag F-323, at a
scope and severity level of K.! CMS also notified Petitioner of a two-year prohibition on
Petitioner conducting a nurse aide training and competency evaluation program
(NATCEP) (imposed both because of the imposition of the DPNA and because of the
amount of the PICMP).” February 10, 2010 Joint Stipulations (Joint Stips.) 1-4;> Centers
for Medicare & Medicaid Services Exhibits (CMS Exs.) 1, 3.

By letter dated August 16, 2010, Petitioner requested a hearing.

In the parties’ joint stipulations (Jt. Stips.) of February 10, 2011, Petitioner agreed not to
contest CMS’s findings of substantial noncompliance with regard to 18 of the 19
deficiencies cited at the May 20, 2010 recertification survey. It agreed to contest only the
findings for the deficiency cited at Tag F-323. CMS agreed to accept June 28, 2010, as
the date Petitioner came back into substantial compliance with participation requirements
(the date Petitioner’s plan of correction indicated as the date it would achieve substantial
compliance). CMS rescinded imposition of the DPNA, which had been effective July 3
through 13, 2010. The parties agreed that the issues remaining in dispute are whether
there was a basis for CMS to impose a PICMP for the deficiency cited at Tag F-323 from
the May 20, 2010 survey and, if so, whether the $7,100 PICMP is reasonable in light of
the factors specified at 42 C.F.R. § 488.438(f). Jt. Stips. 5-7.

I held a hearing in this case in San Francisco, California, from June 20 through 22, 2011.
A 575-page transcript (Tr.) was prepared. Testifying were: Susan Coombs, R.N.
(Surveyor Coombs), at the time of the survey a health facilities evaluator nurse with the
state agency and the team leader for the May survey of Petitioner’s facility; Captain Mary
Gessay (Captain Gessay), a federal surveyor in the Division of Survey and Certification,
Region IX, CMS; Simon Chereme, R.N. (Surveyor Chereme), a health facilities evaluator
nurse with the state agency; Leila Antonio, R.N. (DON Antonio), Petitioner’s Director of
Nursing (DON); Emar Bermudes, R.N. (RN Bermudes), the Regional Director of Clinical
Operations for Covenant Care, an entity of which Petitioner is a part; and Celine
Schweitzer, R.N. (RN Schweitzer), a nursing supervisor at the facility. I admitted CMS
Exs. 1-10, 12-21, 32, 34, 36, 38, 40, 42, 43, 45, 46, 48, and 49. I admitted Petitioner’s
exhibits (P. Exs.) 1-32. Tr. at 559. Both parties filed post-hearing briefs (CMS and P.
Br.) and post-hearing answer briefs (CMS and P. Ans. Br.).

' A scope and severity level of K denotes a pattern of deficiencies that constitute
immediate jeopardy to resident health and safety. State Operations Manual (SOM),

§ 7400E; 42 C.F.R. §§ 488.301, 488.404, 488.408.

? Petitioner did not contest the loss of NATCEP. However, even if it was contested, the
PICMP I uphold ($7,100) demands the two-year NATCEP bar.

* Page 3 of the joint stipulation shows the date the stipulation was signed to be February
10, 2010, but that is an obvious typographical error.
IL. Issues
The issues before me are:

1. Whether Petitioner was in substantial compliance with participation
requirements in the Medicare and Medicaid programs; and

2. Whether the remedies imposed are reasonable.
III. Controlling Law

Sections 1819 and 1919 of the Social Security Act (Act) and the regulations at 42 C.F.R.
Part 483 govern Petitioner’s participation in Medicare and Medicaid. Sections 1819 and
1919 of the Act provide the Secretary of Health and Human Services (Secretary) with
authority to impose remedies, including CMPs, against long-term care facilities for
failure to comply with participation requirements.

Regulations define the term “substantial compliance” to mean:

[A] level of compliance with the requirements of participation such that any
identified deficiencies pose no greater risk to resident health or safety than the
potential for causing minimal harm.

42 C.F.R. § 488.301.

The Secretary has delegated to CMS and the states the authority to impose remedies
against long-term care facilities not complying substantially with federal participation
requirements. The applicable regulations at 42 C.F.R. Part 488 provide that state survey
agencies, on behalf of CMS, may survey facilities participating in Medicare and
Medicaid to ascertain whether the facilities are complying with participation
requirements. 42 C.F.R. §§ 488.10-488.28. The regulations contain special survey
conditions for long-term care facilities. 42 C.F.R. §§ 488.300-488.335. Under Part 488,
a state or CMS may impose a CMP against a long-term care facility if a state survey
agency ascertains that the facility is not complying substantially with participation
requirements. 42 C.F.R. §§ 4 88.406, 488.408, and 488.430. The CMP may begin to
accrue as early as the date that the facility was first substantially out of compliance and
may continue to accrue until the date the facility achieves substantial compliance, or until
CMS terminates the facility’s provider agreement. 42 C.F.R. § 488.440.

The regulations specify that if a CMP is imposed against a facility based on an instance
of noncompliance, the CMP will be in the range of $1000 to $10,000 per instance. 42
C.F.R. § 488.438(a)(2). When a CMP is imposed against a facility on a per day basis, it
must fall into one of two broad ranges of penalties. 42 C.F.R. §§ 488.408, 488.438. The
upper range of CMP, from $3,050 per day to $10,000 per day, is reserved for deficiencies
that constitute immediate jeopardy to a facility’s residents and, in some circumstances,
for repeated deficiencies. 42 C.F.R. § 488.438(a)(1)(i), (d)(2). The lower range of CMP,
from $50 per day to $3,000 per day, is reserved for deficiencies that do not constitute
immediate jeopardy, but either cause actual harm to residents or cause no actual harm,
but have the potential for causing more than minimal harm. 42 C.F.R. §
488.438(a)(1)(ii). “Immediate jeopardy” is defined as:

[A] situation in which the provider’s noncompliance with one or more
requirements of participation has caused, or is likely to cause, serious injury, harm,
impairment, or death to a resident.

42 C.F.R. § 488.301.

Sections 1819(f)(2)(B) and 1919 (£)(2)(B) of the Act prohibit approval of a NATCEP if
within the last two years the facility has been subject to, among other things, an extended
or partial extended survey; imposition of a CMP of not less than $5,000; or imposition or
a denial of payment for new admissions.

The Act and regulations make a hearing before an Administrative Law Judge (ALJ)
available to a long-term care facility against which CMS has determined to impose an
enforcement remedy. Act, section 1128A(c)(2), 1866(h); 42 C.F.R. §§ 488.408(g),
498.3(b)(13). The hearing before an ALJ is a de novo proceeding. The Residence at
Salem Woods, DAB No. 2052 (2006); Cal Turner Extended Care, DAB No. 2030 (2006);
Beechwood Sanitarium, DAB No. 1906 (2004); Emerald Oaks, DAB No. 1800, at 11
(2001); Anesthesiologists Affiliated, DAB CR65 (1990), aff’d, 941 F.2d 678 (8th Cir.
1991). A facility has the right to appeal a certification of noncompliance leading to an
enforcement remedy. 42 C.F.R. § 488.408(g)(1); 42 C.F.R. §§ 488.430(e), 498.3.
However, the choice of remedies, or the factors CMS considered when choosing
remedies are not subject to review. 42 C.F.R. § 488.408(g)(2). A facility may challenge
the scope and severity that CMS cites only if a successful challenge would affect the
range of CMP amounts that CMS imposed or would affect the facility’s NATCEP. 42
C.F.R. § 498.3(b)(14), (d)(10)(i). CMS’s determination as to the scope and severity of
non-compliance “must be upheld unless it is clearly erroneous.” 42 C.F.R. §
498.60(c)(2). This includes CMS’s finding of immediate jeopardy. Woodstock Care
Center, DAB No. 1726, at 9 (2000), aff'd, Woodstock Care Center v. U.S. Department of
Health and Human Services, 363 F.3d 583 (6th Cir. 2003). The Departmental Appeals
Board (Board) has long held that the net effect of these regulations is that a provider has
no right to challenge the scope and severity assigned to a noncompliance finding except
in the situation where that finding is the basis for an immediate jeopardy determination.
See, e.g., Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750
(2000). ALJ review of a CMP is subject to 42 C.F.R. § 488.438(e).*

The standard of proof or quantum of evidence required is a preponderance of the
evidence. CMS has the burden of coming forward with evidence and making a prima
facie showing of a basis for imposition of an enforcement remedy. Petitioner bears the
burden of persuasion to show by a preponderance of the evidence that it was in
substantial compliance with participation requirements or any affirmative defense.
Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing &
Convalescent Center, DAB No. 1904 (2004), aff'd, Batavia Nursing & Convalescent
Center v. Thompson, 129 F. App’x 181 (6th Cir. 2005); Emerald Oaks, DAB No 1800;
Cross Creek Health Care Center, DAB No. 1665 (1998); Hillman Rehabilitation Center,
DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. United States, No. 98-
3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999).

IV. Discussion

I make numbered findings of fact and conclusions of law (Findings) to support my
decision. I set them forth below as separate headings, in bold and italic type, and discuss
each in detail.”

At the outset, I note that Petitioner moved at hearing to dismiss one of the deficiency
citations under Tag F-323 (regarding unsafe side rails), as well as the $7,100 PICMP. In
its answer brief, Petitioner asserts that the motion should be granted because CMS did not

* Although recognizing that the “prevailing interpretation of the regulations” precludes
its challenging the immediate jeopardy determination where only a PICMP has been
imposed, Petitioner argues forcefully that it should be permitted to challenge the
immediate jeopardy finding and thus the scope and severity assigned to the deficiency. P.
Br. at 26-29. Insofar as Petitioner asserts that it has a constitutional due process right to
do so, I am without the authority to hear those arguments. However, its due process
argument is preserved for appeal. Where Petitioner argues that it should be allowed to
address the immediate jeopardy determination in challenging the reasonableness of the
PICMP, as noted above, my review of the CMP is governed by 42 C.F.R. § 488.438(e)
and it is under that standard that I evaluate the reasonableness of the PICMP.

* [have reviewed the entire record, including all the exhibits and testimony. Because the
Federal Rules of Evidence do not control the admission of evidence in proceedings of this
kind (see 42 C.F.R. § 498.61), I may admit evidence and determine later, upon a review
of the record as a whole, what weight, if any, I should accord that evidence or testimony.
To the extent that any contention, evidence, or testimony is not explicitly addressed or
mentioned, it is not because I have not considered the contentions. Rather, it is because I
find that the contentions are not supported by the weight of the evidence or by credible
evidence or testimony.
specifically reference the motion in its post-hearing briefing. P. Ans. Br. at 2, citing Tr.
at 509-10. I deny the motion. The entire thrust of CMS’s post-hearing brief references
why I should sustain the deficiency findings and the PICMP.

CMS noted at hearing that facts common to the F-Tag at issue here, Tag F-323, are also
common to two of the deficiencies which were stipulated to be not at issue in this case.
Specifically, Petitioner agreed,

... to accept CMS’s finding of substantial noncompliance and agrees not to
challenge eighteen of the nineteen deficiencies cited at the May 20, 2010
recertification survey. Buena Vista contests the findings for the deficiency cited at
F-323 (K) from the recertification survey conducted on May 20, 2010.

Jt. Stips. 5. Based on this stipulation, CMS moved for a ruling that the facts underlying
these two deficiencies be found not to be in dispute and administratively final. Tr. at 35-
36. Petitioner responds that the purpose of the joint stipulation was to narrow the issues
for appeal. Petitioner asserts it reserved the right to contest the deficiency at Tag F-323
and that CMS’s reading of the joint stipulation is incorrect. P. Br. at 26; P. Ans. Br. at 2
(which states that since CMS’s brief did not address this motion CMS had thus conceded
Petitioner’s position). I deny CMS’s motion. The language of the stipulation does not
support CMS’s argument that the facts underlying the deficiency citations are not
contested where Petitioner specifically reserved contesting the findings underlying the
deficiency cited at Tag F-323.

1. Petitioner failed to comply substantially with the participation requirement at
42 C.F.R. § 483.25(h) (Tag F-323).

42 C.F.R. § 483.25 requires that:

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.

The subsection at 42 C.F.R. § 483.25(h) references accidents and requires that:

(h) 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.
In the case of Meridian Nursing Center, DAB No. 2265, at 3 (2009), the Board described
the requirements of this section, stating:

Section 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). Section 483.25(h)(2) 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 Center, DAB No. 2115, at 11
(2007), citing Woodstock Care Ctr. v. Thompson, DAB No. 1726 (2000) (facility
must take “all reasonable precautions against residents’ accidents”), aff'd,
Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003).

The Board has also held that facilities “have the ‘flexibility to choose the methods of
supervision’ to prevent accidents so long as the methods chosen are adequate in light of
the resident’s needs and ability to protect himself or herself from a risk.” Briarwood
Nursing Center, DAB No. 2115, at 5, citing Liberty Commons Nursing and Rehab —
Alamance, DAB No. 2070, at 3 (2007).

The Board stated in Briarwood Nursing Home, DAB No. 2115, that:

[T]he “mere fact that an accident occurred does not, in itself, prove that the
supervision or devices provided must have been inadequate to prevent it.”
Josephine Sunset Home, DAB No. 1908, at 13 (2004). On the other hand, it is not
a prerequisite to finding noncompliance under section 483.25(h)(2) that any actual
accident have occurred or be caused by the inadequate supervision to find
noncompliance. Woodstock at 17. The occurrence of an accident is relevant to
the extent the surrounding circumstances shed light on the nature of the
supervision being provided and its adequacy for the resident’s condition. St.
Catherine’s Care Center of Findlay, Inc., DAB No. 1964, at 12 (2005) (accident
circumstances may support an inference that the facility’s supervision of a resident
was inadequate). The focus is on whether the facility took all reasonable steps to
ensure that a resident receives supervision and assistance devices that met his or
her assessed needs and mitigate foreseeable risk of harm from accidents.
Woodstock Care Center v. Thompson, 363 F.3d at 590 (facility must take “all
reasonable precautions against residents’ accidents”).

The regulation speaks in terms of ensuring that what is “practicable” and
“possible” to do is done. What is thus required of facilities is not
prescience but reason and professional judgment in assessing what can be
done to make residents (given their special needs) safe, through removing
accident hazards, providing appropriate devices, and ensuring adequate
supervision.

Josephine Sunset Home, at 14-15.

Briarwood Nursing Center, DAB No. 2115, at 11-12.

The Board has also held that the regulations permit facilities some degree of flexibility in
choosing the methods they use to prevent accidents, so long as the chosen methods
constitute an adequate level of supervision. Windsor Health Care Center, DAB No. 1902
(2003), aff'd Windsor Health Center v. Leavitt, 2005 WL 858069 (6th Cir. April 13,
2005). A facility must anticipate what accidents might befall a resident and take steps —
increased supervision or the use of assistance devices — to prevent them. Aase Haugen
Homes, DAB No. 2013 (2006).

In finding Petitioner in violation of this participation requirement, the state agency
determined that Petitioner failed to: (1) identify and replace unsafe side rails for 17 of 44
sampled residents where the rails were utilized for bed mobility;° (2) implement a bed
alarm for Resident 20 after identifying that a tab alarm was ineffective in alerting staff to
unassisted transfers; (3) provide a post-fall rehabilitation assessment and install
wheelchair anti-tip bars for Resident 3; (4) pad Resident 14’s headboard and side rails per
facility policy and develop and implement seizure precautions as part of an individualized
plan of care; (5) promptly answer call lights for Residents 45 and 46; and (6) turn on the
bed alarm to alert staff when Resident 19 was attempting to get out of bed to use the
bathroom. CMS Ex. 1, at 27-45. Below, I address all but one of these alleged violations.
In its post-hearing briefing, CMS did not address whether Petitioner promptly answered
call lights for Residents 45 and 46 and I do not address the issue below because it is not
necessary for me to do so to support the PICMP imposed. Community Skilled Nursing
Centre, DAB No. 1987 (2005); Batavia Nursing and Convalescent Center, DAB No.
1904, at 21-22 (2004), aff'd, Batavia Nursing and Convalescent Center v. Thompson,
DAB No. 04-3325 (6th Cir. April 15, 2005).

A, Petitioner failed to develop an effective system to identify and replace
unsafe side rails.

For 17 residents, Petitioner utilized full metal side rails for bed mobility. These side rails,
which bordered the sides of the mattress,

° Petitioner’s plan of correction to eliminate full-length bed side rails and/or maximize
safety with those rails noted that as of May 11, 2010, Petitioner had 24 beds with full-
length side rails of which 20 were occupied. CMS Ex. 7, at 3. Other references in the
record are to 17 occupied beds with side rails. Whether the count is 17 or 20 is not
relevant to my decision.
were designed to have a metal spacer in the middle of the top and bottom side rail
frame, which allowed the side rail to lengthen when lowered and shorten when
raised. This metal spacer connected the full metal side rail together in the middle .

CMS Ex. 1, at 28; CMS Ex. 7, at 14; CMS Ex. 13; P. Ex. 3. CMS asserts that the mere
fact that Petitioner used these side rails is not at issue. What is at issue, as CMS argues
its case, is an “overarching safety issue” with regard to the condition of the rails and the
revelation by maintenance staff that weekly repairs to the rails were necessary. CMS Br.
at 7.

The SOD relates that the metal spacers provided stability for the side rails. However, the
SOD asserts, and CMS agrees, that Petitioner failed to ensure these metal spacers were
maintained to prevent separation, causing exposed sharp metal edges, instability, and
collapse of the side rail without warning. CMS Ex. 1, at 28. During the May survey, the
surveyors allegedly identified five side rails that were either disconnected at the upper or
lower railing or were observed to have a gap in the middle of the side rail caused by a
missing metal spacer. CMS Ex. 1, at 30-33; CMS Ex. 7, at 22-23. Specifically,
Surveyors Coombs and Chereme, and Captain Gessay, testified variously that they
observed the full length side rails being used and that the five rails were in a state of
disrepair sufficient to present an accident hazard to Residents 36, 37, 38, 42, and 44. The
side rails were found to have gaps in the middle of the bars caused by missing metal
spacers. And according to the surveyors and CMS, Resident 42’s side rail had splits in
the top bar creating a sharp surface. CMS Exs. 1, at 30-33; CMS Ex. 7, at 17, 22-23;
CMS Ex. 13; Tr. at 48, 51, 59, 70-72, 270, 342-44.

CMS alleges that the disconnected side rails exposed Petitioner’s residents to sharp metal
edges at the gap that could have caused serious injury to elderly residents’ fragile skin.
Tr. 207; CMS Ex. 13, at 2. CMS notes that DON Antonio and RN Schweitzer both
testified that elderly residents’ fragile skin leaves them more prone to skin tears. Tr. at
442, 550. CMS asserts that Resident 44, who was capable of being interviewed, reported
to Surveyor Coombs and Captain Gessay that the edges of her disconnected side rail felt
sharp to the touch and that she used her side rails to assist with movement in the bed.
CMS Ex. 1, at 30; Tr. at 51, 150-51, 271-72; CMS Ex. 7, at 17. Surveyor Coombs
testified that she also touched the exposed edges of the side rail and found it sharp. Tr. at
51. Surveyor Coombs testified that when the side rail was lowered it was flush with the
mattress. It was Surveyor Coombs’ opinion that if an elderly resident slid off the edge of
the bed to get to a wheelchair, the gap in the side rail could catch the resident’s leg. Tr. at
55.

CMS also alleges that the disconnected side rails were unstable, wobbly, and leaned out -
away from the bed when a resident grabbed the rail and applied pressure. Surveyor
10

Coombs and Captain Gessay testified specifically that they both observed that the rails
were unstable, wobbly and leaned out during a medication pass when Resident 44
reached for her side rail near the gap and pulled on it as she attempted to move in bed.

Tr. at 50-51, 277-80. Surveyor Coombs testified that this was an accident hazard because
a resident could fall out of bed and “possibly . . . even be impaled by the side rail if it
collapsed.” Tr. at 86-87.

CMS alleges that the possibility of side rail collapse and consequent resident injury is not
merely theoretical or speculative, but very real in these circumstances. CMS Br. at 9-10.
Surveyor Chereme testified that he was in Resident 38’s room with two members of
Petitioner’s maintenance staff, the maintenance supervisor (Mr. Zeimkiewicz) and his
assistant (Mr. Sausedo).’ Mr. Sausedo informed Surveyor Chereme that the metal spacer
had slipped into one part of the disconnected rails. Mr. Sausedo tried to pull the spacer
out with his fingers, could not, and obtained a tool to pry it loose. When he attempted to
align the lower disconnected side rail, the top rail became disconnected, causing the
entire rail to collapse. Surveyor Chereme testified Mr. Sausedo was not handling the side
rail in a rough manner or using the tool to “bang on” the rail, “jerk on” it, or “shake” it
when it collapsed. Tr. at 342-48.

Both Surveyor Coombs and Captain Gessay testified that they were told by the
maintenance staff that because of the problems with the metal spacers weekly repairs had
to be made to the side rails. Tr. at 72,272. Surveyor Coombs testified that Mr.
Ziemkiewicz told her that nursing staff would inform maintenance that a spacer was
missing, and, although there was a maintenance log at the nurse’s station, repairs to the
spacers were not routinely documented. Surveyor Coombs checked the maintenance log
but did not identify any entries regarding spacer repair. Moreover, the facility
administrator did not recall whether he had been made aware of the spacer problem. Tr.
at 81-82. DON Antonio confirmed that Petitioner’s practice is to report side rails needing
repair to the maintenance staff and not to document that a repair needs to be done. Tr. at
429-30.

CMS notes also that despite daily rounds made by assigned staff or department heads
where, among other things, the condition of the side rails was allegedly examined, DON
Antonio could not explain why on May 10 and 11, 2010 (the first two days of the
survey), Petitioner’s personnel did not identify any of the five full-length side rails that
were disconnected and had gaps in the middle until it was brought to their attention by
the survey team. Tr. at 427. CMS notes too that even though Petitioner’s administrator
was a member of the safety committee, he denied knowing about weekly repairs being
made to the full-length side rails or that Petitioner had a problem with spacers sliding into

’ Petitioner submitted the statements of Mr. Ziemkiewicz and Mr. Sausedo in lieu of
testimony. I can afford those statements but little weight as Mr. Ziemkiewicz and Mr.
Sausedo were not made available for cross-examination.

11

bed rails leaving a gap in the middle. However, he informed Surveyor Coombs that
Petitioner was replacing the beds with full-length side rails as funds became available.
CMS Ex. 7, at 7, 13; Tr. at 160.

CMS argues that the “verbal system” in place was not effective in getting a message to
the DON or administrator that the full-length side rails needed weekly maintenance and
thus that their use should be evaluated. CMS asserts that no one was tracking the wear
and tear of the rails, which Petitioner asserts had been in use for over 20 years.
Moreover, Petitioner did not appreciate that disconnected, sharp, wobbly side rails
presented an accident hazard. CMS argues that Petitioner failed to take all reasonable
steps necessary to ensure the environment was free of accident hazards and that it should
ave reasonably foreseen that a dangerous condition existed. Azalea Court, DAB No.
2352 (2010); Woodland Village Nursing Center, DAB No. 2172, at 18 (2008).

Petitioner vigorously disputes Petitioner’s contentions. Petitioner argues both that CMS
failed to make a prima facie case of a deficiency with respect to the side rails and that the
evidence it produced demonstrates that the side rails never posed more than minimal

arm to its residents and that Petitioner had an effective system to keep the side rails (and
all equipment in use at the facility) in good working order. Petitioner argues that CMS
as conflated minor maintenance issues into immediate jeopardy to resident health and
safety.

Petitioner argues specifically that in approximately 20 years of use at the facility, no
resident, family member, or staff member ever noted a resident suffered harm from the
side rails or believed they posed a threat for more than minimal harm. DON Antonio
testified that in her five years of working at the facility no one got “close to being hurt”
by the side rails. Moreover, she testified that she was not aware of an instance of side rail
collapse, other than that identified by the surveyors. Tr. at 394, 397. Nurse Schweitzer
testified that for the 20 years she worked at the facility no one has been hurt by the side
rails. Tr. 538, 540.

Petitioner refers to testimony of its witnesses, DON Antonio and RNs Bermudes and
Schweitzer, that the edges of the side rails were not sharp and that even when the spacer
was correctly in place the allegedly-sharp edges of the side rail tubes were still exposed.
Tr. at 392-93; 527-28, 532-33. Petitioner notes that the photographs of the side rails
(CMS Ex. 13) do not show sharp edges and the totality of the evidence regarding their
supposed sharpness is that Surveyor Coombs and Resident 44 touched the rails.
Petitioner correctly points out that neither Surveyor Coombs nor Resident 44 suffered
even minimal harm from the contact. Tr. at 142. The surveyors did not objectively test
to determine how sharp the side rails were. Petitioner argues that whether residents of
SNFs are frail and elderly, and thus more prone to skin tears, does not amount to or
equate with credible evidence that the side rails in question were dangerously sharp.

12

Petitioner also refers to testimony of its witnesses that the rails were not wobbly to the
point of presenting a safety issue. RN Schweitzer testified that she was not concerned
and the rails were used many times over the years. Tr. at 537. DON Antonio testified
that she had not observed a wobbly side rail and that the approximately one-inch space
between the side rail and mattress meant there was no potential for resident entrapment.
Tr. at 394. Petitioner argues that the surveyors never objectively tested, reviewed records
for, or interviewed anyone regarding “wobbliness.”

With regard to the side rail collapse witnessed by Surveyor Chereme, Petitioner argues
that CMS jumped to an “illogical conclusion” that the rails were coming apart on a
regular basis and presented the likelihood of serious injury. Petitioner asserts that a one-
time occurrence is dissimilar to the way a resident usually employs the side rails, does not
plainly demonstrate anything, and cannot support a citation of this sort based on the

azard of injury. It is Petitioner’s position that there is no competent evidence in the
record that points to a side rail collapse even potentially threatening a resident’s safety.

Petitioner notes that it has been using the side rails for a long time and that for at least the
previous five years of surveys neither the state agency nor CMS has even commented on
the condition of its side rails. Petitioner argues that had the rails posed a safety risk
surely some previous surveyor would have noted the risk.

Petitioner argues that that CMS is incorrect in asserting that Petitioner did not have a
system for identifying and replacing unsafe side rails. Petitioner asserts it had a system
that was 100% successful over a 20-year period. As Petitioner views the question, repair
of side rails was a maintenance issue, not a resident safety issue. Tr. at 532-33.

Petitioner argues that CMS is ignoring information regarding its safety system noting that
Petitioner’s administrator informed Surveyor Coombs that Petitioner had a safety
committee that conducted room rounds and used a form to report issues. These room
rounds were done on a daily basis. Tr. at 384. Equipment safety was checked, despite
Ms. Coombs’ testimony that she did not recall the administrator telling her that the safety
of the side rails should be identified during the room rounds. Equipment was checked as
staff was “looking @ items in room.” Tr. 170-71; CMS Ex. 8, at 8-9. In addition to daily
room rounds, Petitioner had a safety committee that made weekly room checks which
included inspecting bed rails to make sure they were in good working order. CMS Ex. 8,
at 10; Tr. at 166, 387. Ifthe safety committee or employees conducting room rounds
identified equipment issues, the issues were brought up at the standup meeting of
department heads which took place every weekday morning. Tr. at 387-88. Moreover,
anyone on staff could notice something that needed to be fixed and report the defective
equipment to maintenance, a department head wasn’t required to be the one reporting the
defective equipment to maintenance. Tr. at 391. Petitioner also had spare side rails on
the premises and would replace any side rail which could not be fixed. Tr. at 391, 536.
As an additional safety program, Petitioner conducted walking rounds every 30 to 45
days that included each resident’s interdisciplinary team. These were thorough reviews

13

at the resident’s bedside where all equipment the resident used was inspected. Tr. at 515-
16. Petitioner argues that CMS did not fully investigate what safety systems existed, or
simply ignored evidence of the safety systems they claimed did not exist. Despite CMS’s
criticism, Petitioner asserts that the fact that no resident was ever harmed by side rails in
disrepair demonstrates the effectiveness of Petitioner’s safety systems (despite the
missing spacer issue having occurred for over 20 years). Tr. at 532-33.

Petitioner argues the reason that there were not maintenance log entries related to the
spacer repairs is “self-evident: if the issue was significant enough to warrant tracking,
maintenance would have kept records.” P. Ans. Br. at 5. This supports a finding that the
missing spacer was not a safety issue. There is no regulatory requirement of a need to
document minor maintenance activity.

In sum, Petitioner asserts the “overwhelming” weight of the evidence demonstrates that
the side rails posed no potential for more than minimal harm and that its three-layered
safety system of: (1) daily rounds; (2) weekly rounds by the safety committee; and (3)
interdisciplinary team walking rounds was a system that kept its residents safe and was
100% successful in preventing injuries caused by faulty side rails. Petitioner asserts it
thus proactively ensured its side rails were not an accident hazard. Given the side rails’
use for 20 years without incident, there was no basis on which Petitioner believes that it
could have reasonably been expected to foresee that the side rails posed any danger.
CMS’s subjective and hastily formed opinion, without significant observation, interview,
or record review, should not be substituted for Petitioners’ 20 years’ experience of using
the side rails and dealing with minor spacer issues.

I find that CMS has shown, and Petitioner has not been able to rebut, that Petitioner failed
to have an effective system to identify and reduce accident hazards at its facility and
failed to provide adequate supervision and assistance devices (the side rails) to protect its
residents from foreseeable risks. As noted in the Board’s decision in Meadow Wood
Nursing Home, DAB No. 1841, at 18 (2002), “poorly maintained equipment is precisely
the sort of preventable accident hazard that a facility can practicably be expected to
address.” Petitioner relies on its record of 20 years without a side rail accident as
evidence of its compliance with this participation requirement. However, it is not a
prerequisite to my finding noncompliance that an actual accident have occurred. Nor is it
a prerequisite to my finding noncompliance in this instance that Petitioner has never been
cited by the state agency or CMS for prior side rails problems. It is possible that during
other surveys the side rails appeared undamaged or that for some reason its three-layered
safety system was just not working effectively in May 2010. Obviously, there are many
other possibilities that could explain surveyors’ non-citation of the side rails over two
decades, but their number and nature are not important here: what does matter is that,
once again, it is remembered that the absence of real evidence on the point does not
amount to evidence that the side rails were affirmatively determined to be compliant with
program requirements. Thus, the history of Petitioner’s systems with regard to side rails
14

is not relevant in this instance of alleged noncompliance. Instead, I am obliged to
determine whether, during this survey in May 2010 and based on the observations of the
surveyors at that time, an accident hazard existed and whether Petitioner’s residents were
receiving the supervision and assistance devices contemplated by the regulations.

There is no dispute that during the survey the surveyors found five sets of full-length side
rails in which certain rails were disconnected at either the upper or lower railing and were
observed to have a gap in the middle of the side rail caused by a missing spacer. One of
the rails was observed to have a split, or crack, in the top metal bar. These five side rails
represent, at a minimum, one quarter of all the full-length side rails in use at the facility at
that time. Petitioner has not explained how, despite Petitioner’s system of daily and
weekly rounds and monthly interdisciplinary team walking rounds, no one at the facility
was aware, when in May 2010 the surveyors entered the facility, that fully one quarter of
its full-length side rails had observable gaps in the middle of the railings caused by the
missing spacers until the surveyors brought the problem to the facility’s attention. Tr. at
427. Although Mr. Ziemkiewicz and Mr. Sausedo were apparently aware of a general
problem with side rail spacers, there is no evidence of record as to exactly when or how
many times side rails were repaired because there is no documentation regarding the
problem. Even though the administrator served on a safety committee with maintenance
staff, he did not know about the ongoing problem with spacers, although acknowledging
is facility was replacing the full-length side rails.

I do not agree with Petitioner’s argument that the spacer issue was only a minor
maintenance issue. While I cannot determine from Surveyor Coombs’ testimony and the
photographs in CMS Ex. 13 precisely how sharp the ends of the rails might have been, I
need not reference the exact sharpness of the tube ends or whether the rails were likely to
collapse to find noncompliance. I need only credit the observations of the surveyors who
testified at the hearing that the side rails were wobbly and leaned outwards, to agree with
CMS that a wobbly and/or outwardly leaning side rail presents a hazard to a nursing

ome resident using the rails for purposes of bed mobility. Expert testimony is not
necessary in this regard. Moreover, in reviewing the photographs at CMS Ex. 13, the
photograph at CMS Ex. 13, at 3, depicts an obvious gap in the upper rail. It is evident
that a resident exiting the bed could get caught in that gap when the rail is in a lowered
position.

B. Petitioner failed to provide an adequate level of supervision to protect
Resident 20, assessed as a fall risk, from unassisted transfers and
potential falls.

Resident 20 was admitted to the facility on April 19, 2010. CMS Ex. 12, at 1. His
admission assessment of that date revealed he was at high risk for falls due to intermittent
confusion, gait problems, and a history of falls. His daughter informed the facility that he
had previously fallen at night because of confusion and attempting to get out of bed
15

unassisted. CMS Ex. 1, at 35; CMS Ex. 12, at 28, 31, 36, 44. Petitioner’s plan of care to
address Resident 20’s falls included the interventions of: a tab alarm (an alarm attached
to a resident and the resident’s bed that sounds if the resident attempts to get out of bed
unassisted), a mattress on the floor, and keeping the floor free of spills and clutter. CMS
Ex. 1, at 35-36; CMS Ex. 12, at 25. The SOD alleges that Petitioner did not implement a
bed alarm® when a tab alarm was ineffective in alerting staff to an unassisted transfer.
CMS Ex. 1, at 29.

Resident 20 fell twice within days of admission. His first fall was on April 21, 2010, at
approximately 4:30 p.m., during which he sustained a skin tear to his left forearm and
apparently a bump to his head. CMS Ex. 12, at 11, 12; P. Ex. 7, at 5. Facility notes
reflect that Resident 20 stated that he was looking for a telephone, slid out of bed, and
may have bumped his head. Petitioner’s post-fall investigation revealed that his tab
alarm did not activate. CMS Ex. 12, at 3, 11; P. Ex. 7, at 5. When Surveyor Chereme
asked the DON why the tab alarm failed, she indicated it was not functioning properly.
CMS Ex. 1, at 36; CMS Ex. 12, at 3, 11; P. Ex. 7, at 5; Tr. at 340.

In response to the fall, Petitioner’s nursing staff conducted neurological checks (brief
assessments of the nervous system to determine abnormalities in sensation, movement,
and level of consciousness) which the neurological assessment flow sheet indicates were
completed by 12:45 a.m. on April 22, 2010. CMS Ex. 1, at 36; CMS Ex. 12, at 7-8; P.
Ex. 7, at 8. Petitioner also updated Resident 20’s care plan, instructing staff to check the
placement of his tab alarm before, during, and after each shift. CMS Ex. 12, at9. CMS
asserts that Petitioner did not, and should have, documented interventions to increase
Resident 20’s supervision after the neurological checks ended, such as moving Resident
20 closer to the nurse’s station, utilizing a different type of alarm, or placing a telephone
in a position more easily accessible to his bed. CMS Ex. 1, at 36.

Petitioner fell again on April 22, 2010, at about 3:00 a.m. P. Ex. 7, at 2-3. A CNA heard
Resident 20 cry for help and found him on the floor, away from his mattress, with his tab
alarm unattached to his clothing. CMS Ex. 12, at 3, 13,49. When discovered, he was
confused and stated he wanted to call his son and he had pain in his head and left hip.
After being transferred to a hospital, an x-ray revealed he had a left hip fracture. CMS
Ex. 12, at 13, 33. The SOD notes that recommendations for his care upon returning from
the hospital included that the facility should utilize a bed alarm. CMS Ex. 1, at 37.

The SOD states that on May 20, 2010, at 10:00 a.m., a surveyor observed Resident 20 in
a bed lowered to the floor with one side against a wall, a tab alarm attached to the back of
his hospital gown, and a blue foam pad on the right side of the bed. The SOD alleges that

* A bed alarm is a type of safety alarm with a pressure-release pad that activates when a
resident rises off a bed, as opposed to a tab alarm, which is attached to a resident and is
activated when a resident attempts to get up. CMS Ex. 1, at 29.

16

Petitioner continued interventions which had proven to be ineffective, apparently
referring to the tab alarm, and this placed him at risk for further falls. CMS Ex. 1, at 37.

CMS adopts Surveyor Chereme’s testimony that in his professional opinion Petitioner
failed to provide Resident 20 with adequate supervision and assistance devices after his
first fall and continued ineffective interventions placing him at risk for further falls. Tr.
at 341. CMS argues that aside from a brief period of increased supervision associated
with the neurological checks, Petitioner failed to provide alternative and more effective
interventions and Resident 20 suffered serious actual harm, sustaining a fracture during
his second fall. Moreover, CMS asserts that Petitioner admitted that it had no
documentation to prove that any increased visual checks were conducted on Resident 20
after the visual checks associated with the neurological checks stopped. P. Ex. 7, at 13. I
note, however, that nurse’s notes from April 22, 2010, at 2:45 a.m., reflect that Resident
20 was to be visually checked every thirty minutes and as needed. CMS. Ex. 12, at 43;
Tr. at 412.

Petitioner argues that based on its experience with Resident 20, the use of the tab alarm
was still a reasonable intervention after the first fall. Petitioner states it toileted Resident
20 and checked that his tab alarm was functioning and in place 20 minutes before he fell
the second time on April 22, 2010. P. Ex. 7, at 2; Tr. at 412-14. Petitioner argues that
the only reasonable conclusion to be drawn from the second fall is that Resident 20
removed the tab alarm himself. Tr. at 414-15. Finally, Petitioner notes that because he
ad not previously removed the tab alarm, Petitioner had no basis to believe he would do
so. Petitioner asserts CMS acknowledges (Tr. at 355) that residents have the right to
remove a tab alarm. Petitioner notes that it ultimately implemented a bed alarm for
Resident 20, as well as other interventions such as a low bed, a bed against the wall, and
a floor mattress. P. Ex. 7, at 14; Tr. at 415-16. Petitioner argues, however, that CMS
ignored its other interventions when, during the survey, the surveyors decided that the
facility continued an ineffective intervention (the tab alarm) because a surveyor saw a tab
alarm on Resident 20.

Petitioner argues that the presence of the tab alarm during the survey did not increase the
potential for Resident 20 to experience a fall. In fact, Resident 20 did not fall again after
is readmission. Petitioner argues that, as with any new resident, it took time for the
facility to determine what interventions constituted the most effective approach to deal
with Resident 20’s falls, but that it determined the best interventions within “a reasonably
short period of time.” P. Br. at 15. Petitioner notes (P. Ans. Br. at 8) that since CMS’s
briefing did not address the SOD’s allegation that Petitioner was not in substantial
compliance with this F-Tag due to Resident 20 having a tab alarm on during the survey, I
should not consider the issue.

I do not find Resident 20’s having a tab alarm on during the survey to be a deficiency
given the other interventions in place which apparently included a bed alarm. Instead
17

what I examine here is whether the supervision and interventions that Petitioner was
utilizing on April 22, 2010, after the first fall, provided an adequate level of supervision
for Resident 20. Although the facility urges that it was most likely that the tab alarm did
not sound for some apparently mechanical reason, Petitioner also notes that a resident has
the right to remove a tab alarm. Given Resident 20’s obvious propensity for falls,
Petitioner should have re-evaluated its interventions and, as CMS notes, have considered
other possibilities, including the use of a bed alarm. I find disturbing Petitioner’s
argument that it takes time to determine what interventions are the most effective
approach to deal with a resident. Given that Petitioner knew the resident was a fall risk,
Petitioner should, in the interim, have provided the most comprehensive interventions
possible to assure that the resident was actually supervised, provided appropriate assistive
devices, and protected from accidental falls.

C. Petitioner failed to provide an assistive anti-tip device as required by
Resident 3’s care plan.

The SOD indicates that Resident 3 was admitted with diagnoses including dementia,
coronary artery disease, and depression. Resident 3 was assessed on September 13, 2009,
to be confused, to have short and long term memory problems, and to require extensive
assistance with walking, transfer, bed mobility and toilet use. Resident 3’s fall risk
assessment determined him to be at risk for falls, and his August 31, 2009 care plan
identified interventions to counteract his risk for falls to include monitoring for unsteady
gait and balance, side effects of medications, physical and occupational therapy post-fall
evaluations and treatment as needed. CMS Ex. 1, at 38.

Nurse’s notes dated September 24, 2009, reflect that Resident 3 tipped backwards in his
wheelchair, fell, and hit his head. Petitioner’s post-fall care plan was to apply an anti-tip
device’ to his wheelchair to prevent future tipping and falling. However, on May 12,
2010, at 2:30 p.m., Resident 3 was observed by a surveyor propelling himself in his
wheelchair, in the hallway, without the anti-tip device attached. The SOD states that
during an interview, the assistant director of nursing (ADON) confirmed Petitioner failed
to apply the anti-tip device to Resident 3’s wheelchair. During an interview with a
surveyor on May 12, 2010, at 12:00 p.m., a physical therapist and an occupational
therapist both indicated that they did not reassess Resident 3 or his wheelchair after the
fall for safety measures, nor was the anti-tip device added to Resident 3’s wheelchair.
CMS Ex. 1, at 39.

°’ Surveyor Chereme testified that an anti-tip device consists of two metal pieces that
attach to the bottom frame of a wheelchair. It extends out straight and the two tips point
down to the ground. The purpose of an anti-tip device is to prevent a wheelchair from
tipping backward. Tr. at 328.
18

Petitioner does not refute the SOD statements that Resident 3 fell or that he did not have
an anti-tip device on his wheelchair during the May survey. Instead, Petitioner argues
that it provided adequate assistance devices to prevent Resident 3 from experiencing
falls. Petitioner asserts that it provided other measures, including a lap belt, that
constituted adequate assistance devices to prevent accidents because the measures it
provided were effective in preventing further falls. CMS Ex. 9, at 83. Petitioner argues
that the fact Resident 3 experienced no further falls between his September 2009 fall and
the May 10, 2010 survey shows by a preponderance of the evidence that Petitioner was in
substantial compliance by providing reasonable and adequate assistance to Resident 3 to
mitigate his fall risk. Tr. at 410.

When the facility investigated this incident it determined that Resident 3 fell backwards
onto a cement floor when he tried to cross from the patio to the dining room. Tr. at 324.
For this backwards fall, it determined that an anti-tip device should be applied to his
wheelchair. The anti-tip device was added as an intervention to his post-fall care plans.
CMS Ex. 9, at 3, 13, 14. Petitioner also modified his fall risk assessment to an 18, which
indicates he was at high risk for falls. CMS Ex. 9, at 10; Tr. at 326. On May 12, 2010,
Surveyor Chereme observed that Resident 3’s wheelchair was not equipped with an anti-
tip device and confirmed this with Petitioner’s staff. CMS Ex. 9, at 4; Tr. at 329. Given
that Resident 3 fell backwards, the anti-tip device was a reasonable accommodation to
protect the resident that Petitioner appears to have either forgotten to make or
discontinued at some time while apparently not modifying the resident’s care plan. Tr. at
330-32; P. Ex. 4, at 3. Petitioner has not alleged that its interdisciplinary team discussed
the device and decided not to apply it. CMS Ex. 9, at 83. The other interventions that
Petitioner asserts it provided were not specific to preventing a backwards fall. That
Resident 3 did not fall backwards again is providential, but it is not evidence that
Petitioner was in compliance with participation requirements.

D. Petitioner failed to develop an individualized care plan to reduce
Resident 14’s risk of injury from seizures.

Resident 14 suffered a full body seizure on October 29, 2009. The resident was seen to
drool and lost consciousness for about one and a half minutes. CMS Ex. 1, at 39; CMS
Ex. 10, at 8. A care plan for seizures was placed in the resident’s record (CMS Ex. 10, at
18) but the plan was a pre-printed plan giving boxes which could be checked against
various approaches which could be used. None of the approaches on the plan were
checked, and no other approaches for the individualized care of future seizures were
written up. Thus, it is not clear what approaches were to be used if Resident 14 suffered
another seizure. Surveyor Coombs testified that when a preprinted care plan is used it
must be individualized to meet a resident’s needs, and Resident 14’s care plan was not so
modified. Tr. at 92.

19

The facility does have a seizure policy. CMS Ex. 10, at 5-6. One of the purposes of the

policy is to prevent resident injury. One of the approaches, under the “EQUIPMENT”
eading, is to support and protect the resident from injury by padding a resident’s side

rails and the head of their bed.

The SOD alleges that Petitioner was not in substantial compliance with this participation
requirement because it did not follow its written policies regarding seizure management
by permanently padding Resident 14’s side rails and headboard and by not identifying
particularized care plan approaches to protect Resident 14 in the event she had a seizure.
I find that CMS has not made a prima facie case that Petitioner should have permanently
padded the resident’s side rails and headboard. DON Antonio testified that Petitioner’s
seizure policy (CMS Ex. 10, at 6) applies only after a resident is actually having a
seizure. Tr. at 452-53. A plain reading of the policy CMS relies on supports Petitioner’s
argument that the policy is for the care of a resident in an active seizure, not to protect the
resident from future seizures. CMS Ex. 10, at 6. CMS has, however, proved that the care
plan Petitioner devised for Resident 14 was not adequate to ensure that her environment
remained as free of accident hazards as possible or that she received adequate supervision
and assistance devices to prevent her accidentally injuring herself during future seizures.
CMS Ex. 10, at 18; Tr. at 92. While Petitioner argues that the allegation does not state a
violation of 42 C.F.R. § 483.25(h), but instead one of the other regulations in Part 483
that address care planning, the fact is that here Petitioner’s failure to care plan for active
seizures placed Resident 14 at risk of accident.

DON Antonio testified that Petitioner did not have a policy or procedure to prevent harm
related to seizures that were not actually occurring. Moreover, she admitted that
Petitioner did not have any individualized approaches identified in Resident 14’s care
plan to provide for Resident 14’s safety in the event she suffered another seizure. Tr. at
423-25; P. Ex. 5, at 5. While Petitioner argues that it complied with the regulations by
informing the attending physician of the seizure, following which laboratory tests were
ordered and Resident 14 was referred to a neurologist who ordered medication (Petitioner
asserting it was thus following a “physician-ordered, individualized seizure care plan” (P.
Ans. Br. at 9, citing Tr. at 409)), these actions do not take the place of a facility care plan
to ensure that the resident was adequately protected from risk of accident in the event of a
future seizure.

E. Resident 19’s bed alarm did not alert staff when she tried to get out of
bed without assistance.

The SOD alleges that Petitioner failed to turn on a bed alarm to alert staff when Resident
19 was attempting to get out of bed and needed assistance to use the bathroom. Resident
19 was a fall risk and needed assistance in ambulating, and who walked to the bathroom
while incontinent of stool, and then went back to bed creating a great risk of injury. CMS
Ex. 1, at 30.
20

Resident 19 was a cognitively impaired resident who was at high risk of falls and had, in
fact, fallen at the facility on March 23, 2010, and again on April 10, 2010, while
attempting to go to the bathroom. CMS Ex. 32, at 51, 54. She was assessed as requiring
extensive assistance with bed mobility, transfer, toilet use, and personal hygiene. CMS
Ex. 32, at 10; CMS Ex. 1, at 43. After the March 10 fall, the facility instituted
interventions, noted in her care plan, of placing her bed against the wall in the lowest
position, placing a mattress on the floor, and placing a bed alarm in the bed, which alarm
the resident had previously not accepted. CMS Ex. 32, at 20, 53. After the April 10,
2010 fall, the facility determined that the bed alarm activated, the bed was in the correct
position, and the mattress on the floor was in place. To prevent recurrence, Petitioner
recommended that staff reinforce safe practices with Resident 19, such as calling and
waiting for help before getting out of bed, and these interventions were placed in her care
plan. CMS Ex. 32, at 20, 24, 54.

On May 16, 2010, Resident 19 was identified to have diarrhea. The interventions for
toileting on her continence care plan are identified as a prompt toileting every two hours
and to monitor her bowel and bladder status. CMS Ex. 32, at 21, 22; Tr. at 107-08. This
does not appear to have been adjusted to take account of her diarrhea, however. On May
17, 2010, at 1:00 p.m., Surveyor Coombs testified that she observed Resident 19 in her
bed with brown substance on her sock and a brief on the floor of the bathroom with what
appeared to be stool on it. A brown substance was also smeared on the floor. Tr. at 101;
CMS Ex. 32, at 86. Surveyor Coombs further testified that it appeared Resident 19 had
transferred herself back to bed because otherwise the stool would not be on the floor and
on the resident. Tr. at 102. Surveyor Coombs testified that she was concerned that
Resident 19’s bed alarm was not functioning properly because she would have expected
it to go off when Resident 19 changed her weight and transferred off of the bed. Given
the condition of the resident and the room, she would still have expected it to be sending
an alarm. Tr. at 102-03. Surveyor Coombs testified that staff initially told her that
Resident 19 could turn off the bed alarm, but Resident 19 was unable to identify to
Surveyor Coombs how to turn off the bed alarm. Staff suggested to Surveyor Coombs
that someone probably assisted Resident 19 to the bathroom earlier, turned off the alarm
and then forgot to turn it back on. Tr. at 108. Surveyor Coombs testified that she was
concerned for Resident 19 because she had previously fallen and her environment was a
azard with the brown substance on the floor in conjunction with her attempts to get to or
leave the bathroom. Tr. at 109.

Petitioner argues that CMS’s only evidence that Petitioner failed to activate Resident 19’s
bed alarm is the “pure speculation” of a staff member, which Petitioner asserts is not
credible as it was only a guess. Thus, says Petitioner, CMS has not made a prima facie
case of a deficiency. Moreover, Surveyor Coombs could only speculate as to whether the
resident or someone else turned off the alarm. Petitioner argues that even if I determine
CMS made a prima facie case, Resident 19’s bed alarm was in working order because it

21

was checked daily weekdays during room rounds and weekly by the safety committee.
Tr. at 410-11. Even if Resident 19 transferred herself without staff assistance, this
happened despite Petitioner’s practice of toileting her every two hours to address her
incontinence. Tr. at 411; P. Ex. 6, at 3; CMS Ex. 32, at 22. Moreover, Petitioner
suggests that it is more likely that Resident 19 turned the alarm off herself before
transferring herself from the bed, as two staff members told Surveyor Coombs that she
had done so on other occasions. CMS Ex. 34, at 85.

I find that a staff member turned off the alarm, given another staff member’s suggestion
to Surveyor Coombs that a staff member forgot to turn off the alarm in conjunction with
Surveyor Coombs’ observation that Resident 19 herself was not able to turn off the
alarm. Moreover, despite Resident 19’s having fallen twice while attempting to go to the
bathroom, it did not occur to Petitioner to toilet the resident more often than every two
hours when she had diarrhea. It was certainly foreseeable that in this instance the
resident would be likely to get up and go to the bathroom, which I find she did given the
presence of the soiled diaper in the bathroom. It was again simple providence that
Resident 19 did not fall and injure herself.

2. The remedy imposed for the noncompliance, a PICMP of $7,100, is
reasonable.

As noted above, I need not consider CMS’s finding that the deficiency here constituted
immediate jeopardy because the only remedy imposed is a PICMP. In determining
whether the PICMP imposed here is reasonable, I apply the factors listed in 42 C.F.R. §
488.438(f), which include: (1) the facility’s history of non-compliance; (2) the facility’s
financial condition; (3) the 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 at
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 non-compliance; and (3)
the facility’s prior history of non-compliance in general and specifically with reference to
the cited deficiencies.

Petitioner has a history of noncompliance with the participation requirement at issue,
having been issued a G-level citation based on a survey which took place in February
2007 (CMS Ex. 48, at 1). Petitioner has provided no evidence of its financial condition.
Petitioner is culpable for its failure to develop an effective system to identify the hazards
to which residents with full-length side rails were exposed, and failed to take all
reasonable steps to eliminate foreseeable risks from these hazards. Additionally,
Petitioner did not provide adequate supervision and assistive devices and reduce accident
hazards for Residents 20, 3, 14, and 19. The failure to do so placed the residents at risk
of more than minimal harm.
22

While a $7,100 PICMP is in the upper middle range of PICMP that CMS may impose for
an instance of non-compliance, given that I have found several instances of a deficiency
involving Tag F-323, involving different failures on Petitioner’s part, the amount of
PICMP imposed is reasonable and could even be considered de minimis.

V. Conclusion

For the reasons set forth above, CMS is authorized to impose a $7,100 PICMP for
Petitioner’s non-compliance with 42 C.F.R. § 483.25(h).

/s/
Richard J. Smith
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division
Ali S. Makki, M.D.,
(O.I1. File No.: 5-04-40169-9),
Petitioner,

v.

The Inspector General.
Docket No. C-12-17
Decision No. CR2517

Date: March 20, 2012

DECISION

Petitioner, Ali S. Makki, M.D., is a physician licensed to practice in Michigan. He

was convicted of felony health care fraud and other crimes. Because of the fraud
conviction, the Inspector General (I.G.) has excluded him for thirteen years from
participation in the Medicare, Medicaid, and all federal health care programs, as
authorized by section 1128(a)(1) of the Social Security Act (Act). Petitioner now
appeals. For the reasons discussed below, I find that the I.G. properly excluded Petitioner
and that the 13-year exclusion falls within a reasonable range.

I. Background

Petitioner Makki operated a medical office in Dearborn, Michigan. He pled guilty to
knowingly submitting false and fraudulent claims to the Medicare program and was
convicted in federal district court of health care fraud (18 U.S.C. § 1347), as well as
making a material false statement in an immigration document (18 U.S.C. §1546(a)) and
making or subscribing a false income tax return (18 U.S.C. § 7206(1)). IG. Exhibit (Ex.)
3. The District Court entered judgment against him on September 30, 2010. I.G. Ex. 3 at
1.
Ina letter dated August 31, 2011, the I.G. notified Petitioner that he was excluded from
participation in Medicare, Medicaid, and all federal health care programs for a period of
13 years, because he had been convicted of a criminal offense related to the delivery of
an item or service under the Medicare or state health care program. The letter explained
that section 1128(a)(1) of the Act authorizes the exclusion. I.G. Ex. 1.

Petitioner concedes that he was convicted and is subject to exclusion under section
1128(a)(1). P. Br. at 3.

The parties agree that this case does not require an in-person hearing. Order and
Schedule for Filing Briefs and Documentary Evidence at 2 (October 26, 2011). Each
party submitted an initial brief (I.G. Br.; P. Br.). The I.G. submitted four exhibits (1.G.
Exs. 1-4) and Petitioner submitted one exhibit (P. Ex. 1). The LG. submitted a reply brief
(1.G. Reply). In the absence of an objection, I admit into evidence LG. Exs. 1-4 and

P. Ex. 1.

IL. Issue

Because the parties agree that the I.G. has a basis upon which to exclude Petitioner from
program participation, the sole issue before me is whether the length of the exclusion (13
years) is reasonable.

III. Discussion

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).

In this case, Petitioner operated a medical practice and participated in the Medicare
program. He knowingly submitted “false and fraudulent” claims to the Medicare
program for x-rays that “were both not rendered and inadequately rendered.” Because of
his fraud, the Medicare program paid him approximately $113,777 to which he was not
entitled. I.G. Ex. 2 at 3; LG. Ex. 4 at 1.

On June 30, 2010, Petitioner was charged with one count of health care fraud, in violation
of 18 U.S.C. § 1347; one count of making a material false statement in an immigration
document, in violation of 18 U.S.C. § 1546(a); and one count of filing a false income tax
return, in violation of 26 U.S.C. § 7206(1). LG. Ex. 4. On July 8, 2010, he signed an
agreement with prosecutors, pleading guilty to all three counts. I.G. Ex. 2. The federal
district court for the Eastern District of Michigan accepted his plea and imposed
judgment against him on September 30, 2010. 1.G. Ex. 3. The court sentenced Petitioner
to 24 months in prison followed by three years of supervised release. The court found
that Petitioner’s crimes cost the Medicare program $113,777.00. It credited Petitioner
with having repaid the program $46,541.65, and ordered him to pay an additional
$67,235.35 in restitution. The court also ordered Petitioner to pay a $15,000 fine and
$300 assessment. I.G. Ex. 3 at 3, 6, 7.

Based on the aggravating factors in this case and the
absence of any mitigating factor, the 13-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
four that the parties agree are present in this case: 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; 3) the sentence imposed by the court
included incarceration; and 4) the individual was convicted of other offenses besides
those that formed the basis for his exclusion. 42 C.F.R. § 1001.102(b)(1),(2),(5) and (9).
The presence of an aggravating factor or factors not offset by any mitigating factor or
factors justifies lengthening the mandatory period of exclusion.

Financial loss to Medicare (42 C.F.R. § 1001.102(b)(1)). Petitioner’s actions resulted in
a program financial loss well in excess of $5,000. The district court found, and Petitioner
concedes, that his fraud cost the Medicare program $113,777. I.G. Ex. 3 at 6. Because
the financial losses were significantly in excess of the threshold amount for aggravation
(almost 27 times greater), the I.G. may justifiably increase significantly the 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 pled guilty to criminal acts
that were committed over a period of more than five years, beginning in about July 2004
and continuing until September 18, 2009, more than five times longer than necessary to
constitute an aggravating factor. I.G. Ex. 2 at 3; LG. Ex. 4 at 1.

'T make this one finding of fact/conclusion of law.
Incarceration (42 C.F.R. § 1001.102(b)(5)). The sentence imposed by the criminal court
included two years in prison, which is substantial. LG. Ex. 3 at 3. See Jeremy Robinson,
DAB No. 1905 at (2004) (characterizing a nine-month incarceration as “relatively
substantial.”).

Other offenses (42 C.F.R. § 1001.102(b)(9)). As noted above, Petitioner was convicted
of two other felonies in addition to the health care fraud upon which his exclusion is
based:

e He made false statements on an immigration document. Knowing the statement to
be false, he nevertheless certified to the Immigration and Naturalization Service
(INS), under penalty of perjury, that an immigrant suffered from “severe
depression.” That fact was material to the INS’s determining whether the
individual could be excused from certain testing requirements for naturalization.

e He filed a false income tax return. Under penalty of perjury, he signed and
submitted his 2003 tax return knowing that it significantly understated his income.
He did not report all of the cash receipts from his business.

LG. Ex. 2 at 3-4; I.G. Ex. 4 at 2-3.
No mitigating factors offset the aggravating factors. See 42 C.F.R. § 1001.102(c).

Petitioner does not deny the existence of the aggravating factors nor claim the existence
of any mitigating factor. Instead, he minimizes the seriousness of his crime, claiming
that all of the x-rays he performed were necessary and suggesting that inadequate billing
procedures (and thus his billing company) were to blame. He also points out that he has
been paying restitution; that the sentencing court imposed the minimum sentence
allowable under federal sentencing guidelines, and that his medical license was
suspended for only six months and one day.” P. Ex. 1. He argues that a 5-year exclusion
would “meet the policy guidelines” and be in the government’s interests.

Felony Medicare fraud is, of course, a very serious crime, and Petitioner’s criminal
conviction definitively establishes that he knowingly submitted false claims, including
claims for x-rays that he did not provide. He may not challenge that finding in this
forum. 42 C.F.R. § 1001.2007(d). Even if no mitigating circumstance were present, he
would be subject to a minimum five-year exclusion.

* T note that suspension of his medical license could have been considered an aggravating
factor under 42 C.F.R. § 1001.102(b)(9) as an adverse action by a state board based on
the same set of circumstances that served as the basis for imposing the exclusion.
And this case presents four significantly aggravating factors: Petitioner was responsible
for program losses 27 times greater that the threshold for aggravation; he engaged in
misconduct five times longer than required for aggravation; he was incarcerated for a
significant amount of time; and he committed two additional felonies that show his
willingness to lie and cheat. I consider those additional convictions powerful evidence
that he is untrustworthy.

IV. Conclusion

So long as the period of exclusion is within a reasonable range, based on demonstrated
criteria, I have no authority to change it. Jeremy Robinson, DAB No. 1905 at 5; Joann
Fletcher Cash, DAB No. 1725 at 17, citing 57 Fed. Reg. 3298, 3321 (1992). In this case,
Petitioner’s crime demonstrates that he presents a significant risk to the integrity of health
care programs. | therefore sustain as reasonable the 13-year exclusion.

/s/
Carolyn Cozad Hughes
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division
Christopher George Collins,
(O.I. File No.: 5-08-40684-9),
Petitioner,

v.

The Inspector General.
Docket No. C-11-685
Decision No. CR2515

Date: May 16, 2012

DECISION

This case poses the question: what is a reasonable period of program exclusion for one of
Detroit’s most successful Medicare beneficiary “recruiters?”

Petitioner, Christopher George Collins, was once a registered nurse licensed to practice in
the State of Michigan. He willfully participated in a massive scheme to defraud the
Medicare program. He pled guilty in United States District Court to conspiracy to
commit health care fraud, a felony. Based on his conviction, the Inspector General (1.G.)
has excluded him from participation in Medicare, Medicaid and all federal health care
programs for a period of 50 years, under section 1128(a)(1) of the Social Security Act
(Act). Here, Petitioner concedes that he must be excluded, but he challenges the length
of that exclusion.

For the reasons set forth below, I find the 50-year exclusion reasonable.
I. Background

Petitioner was a Michigan nurse who, in late spring/early summer 2007, went to work for
Patient Choice Home Healthcare, Inc. (Patient Choice), which purported to be a home
ealth agency providing physical and occupational therapy services to Medicare
beneficiaries in Oak Park, Michigan, a Detroit suburb. After working there for about a
month, he proposed becoming a “beneficiary recruiter” for the agency. In that capacity,
e would solicit Medicare beneficiaries for Patient Choice, offering cash and drugs in
exchange for Medicare patient information. His employer, Muhammad Shahab, agreed
to the scheme, and Petitioner Collins became the agency’s top Medicare beneficiary
recruiter, paying Medicare beneficiaries for their Medicare information, which Patient
Care then used to bill the Medicare program for unnecessary and fictitious services. LG.
Ex. 3 at 2-3; I.G. Ex. 4 at 1-2. The beneficiaries he recruited were neither homebound
nor in need of physical/occupational therapy services, as Petitioner Collins well knew. In
fact, they were destitute and addicted to drugs. Petitioner Collins gave them cash and
narcotics in exchange for their Medicare information and their signatures on medical
documents that the conspirators would use to conceal their fraud. IG. Ex. 4 at 2.

In June 2008, Mr. Shahab and others purchased another “home health agency,” All
American Home Care (All American). Petitioner Collins became that agency’s principal
beneficiary recruiter, operating a network of recruiters whom he paid for patient referrals.
Like Patient Choice, All American paid beneficiaries kickbacks in exchange for their
Medicare information and signatures on blank medical documents; it billed the program
for physical therapy services that either were not provided or were not medically
necessary. Eventually, Petitioner Collins owned the agency. In about June 2009, he
obtained signature authority over all of All American’s accounts and began writing
imself checks for what he believed should have been his portion of the profits from the
fraud. I.G. Ex. 3 at 3-4; LG. Ex. 4 at 3-4.

On January 12, 2010, Petitioner Collins was charged with felony conspiracy to commit
ealth care fraud (18 U.S.C. § 1349), and, on May 13, 2010, he pled guilty to the charge
in federal district court. 1.G. Ex. 3; 1.G. Ex. 4 at 1; 1G. Ex. 5. The Court accepted his
plea, sentenced him to 63 months in prison, and ordered him to pay a whopping
$6,967,500 in restitution to the Medicare Trust Fund. I.G. Ex. 6.

In a letter dated June 30, 2011, the I.G. advised Petitioner that, because of his
convictions, he was excluded from participation in Medicare, Medicaid, and all federal
ealth care programs for a minimum period of 50 years. I.G. Ex. 1. The letter explained
that section 1128(a)(1) of the Act authorizes the exclusion. Petitioner timely requested a
earing to challenge his exclusion.

In compliance with my orders the I.G. has submitted an initial brief (I.G. Br.) and a reply
brief (1G. Reply). The LG. also submitted seven exhibits (I.G. Exs. 1-7), which, in the
absence of any objection, I admit into evidence.

Petitioner presents his case through two documents: one titled Motion Requesting Relief
(P. Motion) and a brief (P. Br.).

The parties agree that this case can be resolved without an in-person hearing. I.G. Br. at
9; P. Br. at 8.

IL. Issue
The sole issue before me is whether the length of the exclusion (50 years) is reasonable.
III. Discussion

Based on the aggravating factors in this case and the
absence of any mitigating factor, the 50-year
exclusion falls within a reasonable range.'

Section 1128(a)(1) of the Act requires 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.

An exclusion brought 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 a basis for lengthening the period of exclusion are
the three that the I.G. relies on in this case: 1) the acts resulting in the conviction, or
similar acts, caused a government program or another entity financial losses 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.

'T make this one finding of fact/conclusion of law.
Petitioner concedes that these aggravating factors apply here, but argues that they do not
justify a ten-fold increase in his period of exclusion. P. Br. at 1.

Program financial loss (42 C.F.R. § 1001.102(b)(1)): As noted above, the district court
ordered Petitioner to pay the Medicare program $6,967,500 in restitution. I.G. Ex. 6 at 5.
Restitution has long been considered a reasonable measure of program losses. See Jason
Hollady, M.D., DAB No. 1855 (2002). Here, Petitioner’s crimes cost the Medicare
program financial losses that were almost /,400 times greater than the $5,000 threshold
for aggravation. The Departmental Appeals Board (Board) has characterized amounts
substantially greater than the statutory standard as an “exceptionally aggravating factor”
that is entitled to significant weight. Jeremy Robinson, DAB No. 1905 (2004); Donald A.
Burstein, PhD., DAB No. 1865 (2003). I agree and consider that the substantial program
loss more than justifies a significant increase in the period of exclusion.

Petitioner complains that this number is exaggerated, that he received only a fraction of
that amount, and that his more culpable co-defendants probably took the bulk of the
money. P. Motion at 2; P. Br. at 2. First, the question is not how much the petitioner
profited, but how much the program lost. As the federal prosecutors told the sentencing
court:

Every dollar that Collins helped divert from this program —
and into the pockets of himself and his co-conspirators — is a
dollar that could have been used to provide valuable services
to Medicare beneficiaries.

LG. Ex. 4 at 8.

In fact, according to court documents, the two ostensible home health agencies with
which Petitioner Collins was associated amassed $14.5 million in Medicare claims in just
two years. I.G. Ex. 4 at 6; LG. Ex. 5 at 9. Petitioner Collins “played a critical role” and
was “one of the principal reasons” for the conspiracy’s generating that much money. He
personally was responsible — either directly as a recruiter or as an owner — for almost half
of the resulting program losses. I.G. Ex. 4 at 6.

In any event, Petitioner Collins admitted and the district court conclusively determined
that he “was responsible for submitting or causing the submission of approximately
$6,967,500 in false or fraudulent claims... .” LG. Ex. 3 at 4. Federal regulations
preclude Petitioner from collaterally attacking the court’s judgment.

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).

I consider the enormity of the program’s financial losses here an exceptionally
aggravating factor that compels a period of exclusion many times longer than the five-
year minimum.

Length of criminal conduct (42 C.F.R. § 1001.102(b)(2)). According to the court
documents, Petitioner’s criminal activity began in approximately August 2007 and
continued through October 2009. I.G. Ex. 3 at 2, 4; LG. Ex. 4 at 1, 3-5. Thus, the acts
that resulted in Petitioner’s conviction and similar acts were committed over a period of
26 to 27 months, more than double the time necessary to constitute an aggravating factor.

Incarceration (42 C.F.R. § 1001.102(b)(5). The sentence imposed by the criminal court
included incarceration. The district court sentenced Petitioner Collins to more than five
years (63 months) in prison. I consider this significant jail time, which underscores the
seriousness of his crimes. I.G. Ex. 6 at 2

No mitigating factors. 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 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’s felony conviction 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 his culpability.

Petitioner claims, however, that he cooperated fully with the FBI and federal prosecutors
“by answering all queries truthfully and to the best of his knowledge,” and points out that
others were indicted in the months following his meetings with government officials. He
speculates that the government must have used the information he provided. P. Br. 6.
Answering questions posed by investigators does not satisfy the regulatory requirement
for mitigation. “It is entirely Petitioner’s burden” to show that his cooperation resulted in
others being convicted or excluded, or additional cases being investigated, or a civil
money penalty being imposed. Stacey R. Gale, DAB No. 1941 at 15 (2004). Petitioner
Collins has not shown that his “cooperation” led to any specific conviction, exclusion, or
the imposition of additional penalties.

Thus, no mitigating factor offsets the significant aggravating factors present in this case.
IV. Conclusion

I recognize that 50 years is a substantial period of exclusion and should be imposed on
those posing a grave threat to program integrity. Petitioner Collins poses such a threat.
The federal prosecutors characterized him as “one of the largest recruiters in Detroit.”
1.G. Ex. 4 at 10. This puts him squarely in the “big leagues” of program fraud and
justifies keeping him out of vulnerable health care programs for the maximum period of
time. As the Board has noted, the I.G. may reasonably determine that increasingly longer
periods of exclusion are necessary not only to protect federal funds, but “‘to staunch an
increasing amount of health care fraud.” Jeremy Robinson, DAB No. 1905 at 6, fn. 8
(2004). Prosecutors in Petitioner Collins’s criminal case cited some sobering statistics:

The National Health Care Anti-Fraud Association, an
organization composed of both public and private health
insurers and regulators, conservatively estimates that 3% of
all health care spending in the United States is lost due to
fraud. If such an estimate is accurate, health care fraud cost
our economy a staggering $68 billion in 2007, the most recent
year for which figures are available.

1G. Ex. 4 at 7. I find heartening the I.G.’s willingness to act aggressively in excluding
proven fraudsters and thus protecting these programs.

I therefore find that a 50-year exclusion falls within a reasonable range.

/s/
Carolyn Cozad Hughes
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Steven C. Wein,
(O.L. File No.: 11-40476-9),

Petitioner,
v.
The Inspector General.
Docket No. C-12-82
Decision No. CR2514

Date: March 15, 2012

DECISION

Petitioner, Steven C. Wein, was an osteopath, licensed in the State of Nevada, who
practiced as a psychiatrist. Following his arrest for “open and gross lewdness,” the
Nevada State Board of Osteopathic Medicine charged him with unprofessional and
unethical conduct and sought to revoke his license. While that disciplinary proceeding
was pending, he voluntarily surrendered his license. Now, pursuant to section 1128(b)(4)
of the Social Security Act (Act), the Inspector General (I.G.) has excluded him from
participation in Medicare, Medicaid, and all federal health care programs until he regains
is license.

For the reasons set forth below, I find that Petitioner Wein surrendered his license while a
formal disciplinary proceeding involving his professional competence or performance
was pending before the state licensing board. The LG. therefore appropriately excluded
im from program participation.

Background

In a letter dated August 31, 2011, the I.G. advised Petitioner Wein that he was excluded
from participation in Medicare, Medicaid, and all federal health care programs because
he had surrendered his license to practice medicine/provide health care as a doctor of
osteopathic medicine while a formal disciplinary proceeding, bearing on his professional
competence, professional performance, or financial integrity, was pending before the
Nevada Board of Osteopathic Medicine. The letter explained that section 1128(b)(4)
authorizes the exclusion. I.G. Ex. 1. Petitioner Wein timely requested review.

The parties have submitted briefs (I.G. Br.; P. Br.). The I.G. also submitted seven
exhibits (I.G. Exs. 1-7), and a reply brief (I.G. Reply). In the absence of any objections, I
admit into evidence I.G. Exs. 1-7.

The parties agree that this case should be resolved without an in-person hearing. I.G. Br.
at 8; P. Br. at 5.

Discussion

Because Petitioner Wein surrendered his license to practice
osteopathic medicine while a formal disciplinary proceeding
bearing on his professional competence or performance was
pending, the I.G. may appropriately exclude him from
participation in Medicare, Medicaid, and other federally
funded health care programs.'

The Act authorizes the Secretary of Health and Human Services to exclude from program
participation an individual who surrendered his license to provide health care while a
formal disciplinary proceeding was pending before any state licensing authority if the
proceeding concerned the individual’s professional competence, professional
performance, or financial integrity. Act § 1128(b)(4); accord 42 C.F.R. § 1001.501(a).

The parties agree that Petitioner Wein voluntarily surrendered his license to practice as an
osteopath while formal disciplinary proceedings were pending against him. I.G. Br. at 3-
4; P. Br. at 1; LG. Exs. 3, 5. Petitioner argues, however, that the conduct that caused the
licensing board to bring charges against him, “did not concern either his professional
competence or his professional performance.” P. Br. at 2. In fact, the state board’s
documents — complaint, settlement agreement and order, order of summary suspension,
and order for medical examination — say otherwise. I.G. Exs. 2, 3,5, 6. Because the
record of the state board proceedings definitively establish that the proceedings
concerned Petitioner Wein’s professional competence, I need not consider the unsavory

'T make this one finding of fact/conclusion of law.
details of the conduct that underlay the board’s actions (which are nevertheless outlined
in some detail in the I.G.’s submissions). 42 C.F.R. § 1001.2007(d) (providing that,
where an exclusion is based on an agency’s prior determination where the facts were
adjudicated and a final decision was made, the underlying basis for that determination is
not reviewable and may not be collaterally attacked).

In a complaint and request for summary suspension, the Nevada State Board of
Osteopathic Medicine charged that Petitioner Wein engaged in unprofessional and
unethical conduct that raised questions about his competence to practice osteopathic
medicine “with reasonable skill and safety to patients.” Specifically, the state board
charged that “acts of open and gross lewdness” constitute unprofessional conduct,
defined as “conduct that is detrimental to the public’s health, safety, and against the
public’s morals,” and unethical conduct, defined as “‘conduct that indicates and/or
constitutes an unfitness to practice osteopathic medicine, especially in the area of
psychiatric medicine dealing with potentially vulnerable patients.” I.G. Ex. 3 at 2-3
(Complaint §§ 5, 9, 10). The complaint alleged that “the public health, safety, and
welfare imperatively require action and summary suspension,” noting that his actions put
the public’s health, safety, and welfare at risk. I.G. Ex. 3 at 3 (Complaint § 13).

The complaint also called for Petitioner Wein to undergo a mental examination to
determine his competence to continue practicing osteopathic medicine. I.G. Ex. 3 at 3
(Complaint § 11); LG. Ex. 6.

A settlement agreement and order, signed by the parties in November 2010 and issued by
the state board on December 7, 2010, reiterated the state board’s charges. I.G. Ex. 2.
Petitioner Wein admitted that he had been convicted of open and gross lewdness, and that

is conviction constituted unprofessional and unethical conduct. He also admitted that
“the alleged criminal acts/conduct occurring in May 2009[sic] in Tempe, Arizona...
may also be considered unprofessional conduct. ...” I.G. Ex. 2 at 3.2 He surrendered his
icense and agreed to pay a fine of $10,593.75 ($5,000 for unprofessional and unethical
conduct in Nevada; $5,000 for unprofessional and unethical conduct in Arizona; and
$593.75 for investigative costs). I.G. Ex. 2 at 3-4. The state board accepted the
agreement and ordered Petitioner Wein’s license surrendered and no longer valid. I.G.
Ex. 2 at 5; I.G. Ex. 5.

Petitioner, nevertheless, argues that he does not fall within the definition of section
1128(b)(4), because the I.G. did not establish that his “unprofessional conduct amounts to
a question of professional competence or performance. ...” P. Br. at 3. That a
disciplinary proceeding charging unprofessional conduct would not necessarily “concern”
competence/performance within the meaning of section 1128(b)(4) is highly

? Petitioner Wein was charged with setting fire to the home of two of the complaining
witnesses in the criminal case then-pending against him. LG. Ex. 7.
questionable. But I need not reach that issue here. The state board determined that
Petitioner Wein engaged in unethical conduct, which it defined as conduct that
“constitutes unfitness to practice osteopathic medicine.” I.G. Ex. 3 at 1 (Complaint § 4)
(emphasis added). Where, as here, a formal disciplinary proceeding involves whether an
individual’s conduct demonstrates that he is unfit to practice medicine, it is a proceeding
that concerns the individual’s professional competence or performance, and the I.G. may
appropriately exclude him from program participation under section 1128(b)(4) of the
Act.

The statute requires that Petitioner Wein’s period of exclusion “shall not be less than the
period during which the individual’s . . . license. . . is. . . revoked, suspended, or
surrendered. ...” Act § 1128(c)(3)(E).

Conclusion

For the above reasons, I conclude that the I.G. properly excluded Petitioner Wein from
participation in Medicare, Medicaid, and all other federal health care programs for so
long as his medical license is suspended.

/s/
Carolyn Cozad Hughes
Administrative Law Judge