Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

St. Joseph Villa Nursing Center
(CCN: 28-5078),

Petitioner
Vv.
Centers for Medicare and Medicaid Services.
Docket No. C-09-127
Decision No. CR2288
Date: November 29, 2010
DECISION

Petitioner, St. Joseph Villa Nursing Center, was not in substantial compliance with
program participation requirements as alleged by the survey completed on May 3, 2007,
due to violations of 42 C.F.R. §§ 483.10(b)(11)(Tag F157) and 483.25(h)(2)(Tag F324).

There is a basis for the imposition of an enforcement remedy. A per instance civil money
penalty (PICMP) of $8,000 is not reasonable. A PICMP of $4,000 is reasonable.

I. Background

Petitioner, located in Omaha, Nebraska, is authorized to participate in Medicare as a
skilled nursing facility (SNF) and in the Medicaid program as a nursing facility (NF).
The Nebraska Department of Health and Human Services System, Department of
Regulation and Licensure, Section for Long Term Care and Assisted Living Facilities
(the state agency), conducted a survey of Petitioner that was completed on May 3, 2007.

The Centers for Medicare and Medicaid Services (CMS) notified Petitioner by letter
dated June 6, 2007, that based on deficiencies found by the May 3, 2007 survey, CMS
was imposing: a PICMP of $8,000; a denial of payment for new admissions (DPNA)
beginning on June 21, 2007 and continuing until Petitioner returned to substantial
compliance; termination of Petitioner’s provider agreement on November 3, 2007, if
Petitioner did not return to substantial compliance before that date; and withdrawal of
Petitioner’s authority to conduct a Nurse Aide Training and Competency Evaluation
Program (NATCEP). Request for Hearing (RFH) at 1-2; RFH Exhibit (RFH Ex.) A;
CMS Exhibit (CMS Ex.) 1, at 12. The state agency conducted a revisit survey in July
2007 and determined that Petitioner returned to substantial compliance as of May 30,
2007. RFH at 2; RFH Ex. C; CMS Ex. 1, at 16. The DPNA and termination remedies
were never effectuated.

Petitioner requested a hearing on August 2, 2007. The request for hearing was assigned
to me on August 7, 2007. A hearing was convened in this case on April 1, 2008, in
Omaha, Nebraska. Petitioner appeared represented by counsel. No representative for
CMS appeared. Petitioner’s exhibits (P. Ex.) 1 through 39 were admitted without
objection. Transcript (Tr.) at 27. On June 6, 2008, I issued a decision concluding that
CMS had failed to make a prima facie showing that Petitioner was not in substantial
compliance with program participation requirements and that no basis existed to impose
an enforcement remedy. An appellate panel of the Departmental Appeals Board (the
Board) issued a decision on December 8, 2008, reversing my decision. The Board
remanded the case to me with directions to receive the CMS exhibits not offered at the
prior hearing and for other appropriate action.

A second hearing was held in this case on May 19 and 20, 2009, in Omaha, Nebraska.
CMS offered CMS exhibits 1 through 16. CMS exhibits 1, 2, 3 (except page 15), 6
(except pages 1-4, 27-28, 38-39, 107-18), 7, 8, 9 (except pages 1-3, 15-16, 20-21), 10, 11
(except page 1), 12 (except page 1), 13 (except page 1), 14 (except page 1), and 16 were
admitted. Tr. at 66-68. CMS called Surveyor Ron Chase, Registered Nurse (RN) as a
witness. Petitioner called the following witnesses: Donald R. Frey, MD; Tiffany
Harrahill, a Licensed Registered Occupational Therapist (OTR/L); Jennifer O’Neil,
OTRIL; Nicole Halski, Licensed Practical Nurse (LPN); Hector Lequillow, LPN; and
Mary Malone, RN. The parties filed post-hearing briefs (CMS Br. and P. Br.) and post-
hearing reply briefs (CMS Reply and P. Reply).

II. Discussion
A. Issues
The issues in this case are:
Whether there is a basis to impose an enforcement remedy; and

Whether the proposed enforcement remedy is reasonable.
B. Applicable Law

The statutory and regulatory requirements for participation by a long-term care facility
are found at sections 1819 (SNF) and 1919 (NF) of the Social Security Act (Act) and at
42 C.F.R. Part 483.' Section 1819(h)(2) of the Act vests the Secretary of Health and
Human Services (Secretary) with authority to impose enforcement remedies against a
SNF for failure to comply substantially with the federal participation requirements
established by sections 1819(b), (c), and (d) of the Act.” Pursuant to 1819(h)(2)(C), the
Secretary may continue Medicare payments to a SNF not longer than six months after the
date the facility is first found not in compliance with participation requirements.
Pursuant to 1819(h)(2)(D), if a SNF does not return to compliance with participation
requirements within three months, the Secretary must deny payments for all individuals
admitted to the facility after that date — commonly referred to as the mandatory or
statutory DPNA. In addition to the authority to terminate a noncompliant SNF’s
participation in Medicare, the Act grants the Secretary authority to impose other
enforcement remedies, including a discretionary DPNA, civil money penalties (CMP),
appointment of temporary management, and other remedies such as a directed plan of
correction. Act § 1819(h)(2)(B).

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

§ 488.301 (emphasis in original). A deficiency is a violation of a participation
requirement established by sections 1819(b), (c), and (d) of the Act or the Secretary’s
regulations at 42 C.F.R. Part 483, subpart B. State survey agencies on behalf of CMS
may survey facilities that participate in Medicare to determine whether the facilities are
complying with federal participation requirements. 42 C.F.R. §§ 488.10-.28, 488.300-
.335. The regulations specify the enforcement remedies that CMS may impose if a
facility is not in substantial compliance with Medicare requirements. 42 C.F.R. §
488.406.

' All references are to the 2006 version of the Code of Federal Regulations (C.F.R.),
which was in effect at the time of the survey, unless otherwise indicated.

> Section 1919(h)(2) of the Act gives similar enforcement authority to the states to
ensure that NFs comply with their participation requirements established by sections
1919(b), (c), and (d) of the Act.
CMS may impose a CMP for the number of days a facility is not in substantial
compliance or for each instance of noncompliance. 42 C.F.R. § 488.430(a). The
regulations specify that a CMP that is imposed against a facility on a per day basis will
fall into one of two ranges of penalties. 42 C.F.R. §§ 488.408, 488.438. The upper range
of a CMP, $3,050 per day to $10,000 per day, is reserved for deficiencies that pose
immediate jeopardy to a facility’s residents and, in some circumstances, for repeated
deficiencies. 42 C.F.R. §§ 488.438(a)(1)(i), (d)(2). “Immediate jeopardy means a
situation in which the provider’s noncompliance with one or more requirements of
participation has caused, or is likely to cause, serious injury, harm, impairment, or death
to a resident.” 42 C.F.R. § 488.301 (emphasis in original). The lower range of a CMP,
$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). A
PICMP may range from $1,000 to $10,000, and the range is not affected by the presence
of immediate jeopardy. 42 C.F.R. § 488.438(a)(2).

Petitioner was notified in this case that the state agency could not approve and withdrew
any prior approval of Petitioner to conduct a NATCEP. Petitioner advised me at hearing
that, while it did not have a NATCEP, it desired to have such a program in the future.
Although the two year ban had already elapsed by the time of the second hearing,
Petitioner wanted to preserve its right to review of the deficiencies upon which the ban
was based. Tr. at 5-7. Pursuant to sections 1819(b)(5) and 1919(b)(5) of the Act, SNFs
and NFs may only use nurse aides who have completed a training and competency
evaluation program. Sections 1819(e) and 1919(e) of the Act impose upon the states the
requirement to specify what NATCEPs they will approve that meet the requirements that
the Secretary established and a process for reviewing and re-approving those programs
using criteria that the Secretary set. Pursuant to sections 1819(f)(2) and 1919(f)(2), the
Secretary was tasked to develop requirements for approval of NATCEPs and the process
for review of those programs. The Secretary promulgated regulations at 42 C.F.R. Part
483, subpart D. Pursuant to 42 C.F.R. § 483.151(b)(2) and (e)(1), a state may not
approve and must withdraw any prior approval of a NATCEP that a SNF or NF offered
that: (1) has been subject to an extended or partial extended survey under sections
1819(g)(2)(B)(i) or 1919(g)(2)(B)(i) of the Act; (2) has been assessed a CMP of not less
than $5,000; or (3) has been subject to termination of its participation agreement, a
DPNA, or the appointment of temporary management. Extended and partial extended
surveys are triggered by a finding of “substandard quality of care” during a standard or
abbreviated standard survey and involve evaluating additional participation requirements.
“Substandard quality of care” is identified by the situation where surveyors identify one
or more deficiencies related to participation requirements established by 42 C.F.R. §
483.13 (Resident Behavior and Facility Practices), § 483.15 (Quality of Life), or § 483.25
(Quality of Care) that are found to constitute either immediate jeopardy, a pattern of or
widespread actual harm that does not amount to immediate jeopardy, or a widespread

potential for more than minimal harm that does not amount to immediate jeopardy and
there is no actual harm. 42 C.F.R. § 488.301.

The Act and regulations make a hearing before an administrative law judge (ALJ)
available to a long-term care facility against which CMS has determined to impose an
enforcement remedy. Act §§ 1128A(c)(2), 1866(h); 42 C.F.R. §§ 488.408(g),
498.3(b)(13). 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 a right to appeal a “certification of noncompliance leading to
an enforcement remedy.” 42 C.F.R. § 488.408(g)(1); 42 C.F.R. §§ 488.330(e), 498.3.
However, the choice of remedies, or the factors CMS considered when choosing
remedies, is not subject to review. 42 C.F.R. § 488.408(g)(2). A facility may only
challenge the scope and severity level of noncompliance that CMS determined, if a
successful challenge would affect the range of the CMP that may be imposed or impact
the facility’s authority to conduct a NATCEP. 42 C.F.R. § 498.3(b)(14), (d)(10)(i). The
CMS determination as to the level of noncompliance, including the finding of immediate
jeopardy, “must be upheld unless it is clearly erroneous.” 42 C.F.R. § 498.60(c)(2);
Woodstock Care Ctr., DAB No. 1726, at 9, 38 (2000), aff'd, 363 F.3d 583 (6th Cir.
2003). The Board has long held that the net effect of the regulations is that a provider has
no right to challenge the scope and severity level assigned to a noncompliance finding,
except in the situation where that finding was the basis for an immediate jeopardy
determination. See, e.g., Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB
No. 1750 (2000). ALJ review of a CMP is subject to 42 C.F.R. § 488.438(e).

The standard of proof, or quantum of evidence required, is a preponderance of the
evidence. CMS has the burden of coming forward with the evidence and making a prima
facie showing of a basis for 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 Ctr., DAB No. 1904 (2004), aff'd, 129 F. App’x. 181
(6th Cir. 2005); Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004); Emerald
Oaks, DAB No. 1800; Cross Creek Health Care Ctr., DAB No. 1665 (1998); see
Hillman Rehab. Ctr., DAB No. 1611 (1997), aff’d, No. 98-3789, 1999 WL 34813783
(D.N.J. May 13, 1999).

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

My conclusions of law are set forth in bold followed by my findings of fact and analysis.
The survey that was completed on May 3, 2007, cited Petitioner for the following
deficiencies: 42 C.F.R. §§ 483.10(b)(11) (Tag F157, scope and severity (s/s) J
(immediate jeopardy)); 483.20(d)(3) and 483.10(k)(2) (Tag F280, s/s D (potential for
more than minimal harm)); 483.25 (Tag F309, s/s G (actual harm)); and 483.25(h)(2)
(Tag F324,° s/s K (immediate jeopardy)). CMS Ex. 2. CMS imposed the $8,000 PICMP
based upon Tags F157 and F324, the tags cited as posing immediate jeopardy. CMS Ex.
1, at 12. The only remedy at issue before me is the proposed $8,000 PICMP. No remedy
was imposed based upon Tag F280 or Tag F309 and those deficiencies are not subject to
my review.’ 42 C.F.R. §§ 488.408(g)(i); 498.3(b)(13).

CMS argues that Petitioner violated 42 C.F.R. §§ 483.10(b)(11) (Tag F157) and
483.25(h)(2) (Tag F324). CMS only discusses in its briefs the examples from the
Statement of Deficiencies related to Resident 1. I do not apply the doctrine of waiver
against CMS but consider each alleged example under both deficiency citations as
discussed hereafter. I have carefully considered all the evidence, including the
documents and the testimony at hearing and the arguments of both parties, though not all
may be specifically discussed in this decision.° I discuss in this decision the credible

> CMS amended the State Operations Manual (SOM), app. PP and deleted Tag F324
effective August 17, 2007. Violations of 42 C.F.R. § 483.25(h)(1) and (2) are bot
covered by SOM, app. PP, Tag F323. However, Tag F324 is used in this decision as the
version of the SOM in effect at that time of the survey included Tag F324. Although the
SOM does not have the force and effect of law, the provisions of the Act and regulations
interpreted clearly do have such force and effect. State of Indiana by the Indiana Dep’t
of Public Welfare v. Sullivan, 934 F.2d 853 (7th Cir. 1991); Northwest Tissue Ctr. v.
Shalala, | F.3d 522 (7th Cir. 1993). Thus, while the Secretary may not seek to enforce
the provisions of the SOM, she may seek to enforce the provisions of the Act or
regulations as the SOM interprets.

* The ban on approval to conduct a NATCEP was triggered by the $8,000 PICMP in this
case, as there was no extended or partial extended survey based upon a finding of
substandard quality of care (Tr. at 114), the DPNA was not effectuated, termination was
not effectuated, and temporary management was not imposed. Thus, the ban on
NATCEP approval does not trigger my jurisdiction to review Tags F280 and F309,
neither of which is cited as a basis for the PICMP or amounted to substandard quality of
care that would have triggered an extended or partial extended survey.

> Petitioner includes in its Prehearing Brief a laundry list of twenty-three arguments
attacking the constitutionality of the statutes, regulations, and procedures that are the
survey, certification, and enforcement process. Petitioner’s Prehearing Brief at 35-40; P.
Br. at 30. My jurisdiction is limited to the issues discussed in this decision, and I do not
address the issues raised by Petitioner over which I have no authority.
evidence given the greatest weight in my decision-making.° The fact that evidence is not
specifically discussed should not be considered sufficient to rebut the presumption that I
considered all the evidence and assigned such weight or probative value to the credible
evidence that I determined appropriate within my discretion as an ALJ. There is no
requirement for me to discuss the weight given every piece of evidence considered in this
case, nor would it be consistent with notions of judicial economy to do so.

1. Petitioner violated 42 C.F.R. § 483.10(b)(11) (Tag F157).

The surveyors allege in the SOD that Petitioner violated 42 C.F.R. § 483.10(b)(11),
because Petitioner failed to notify the physicians for Resident 1 and Resident 4 that they
had a change in condition related to skin burns from spilled hot liquid. CMS Ex. 2, at 2.
I conclude that Petitioner violated the regulation by failing to immediately consult
Resident 1’s physician on April 14, 2007, when the burn blister was observed to be open,
the area around the open blister was observed to be reddened, and the resident made
repeated complaints of pain that required administration of pain medication. I do not find
a violation in the case of Resident 4.

(a) Facts.

Resident 1, a female, was 76 years old at the time of the survey. Her Minimum Data Set
(MDS) with an assessment reference date of March 29, 2007, lists diagnoses of chronic
obstructive pulmonary disease (COPD) or emphysema, hypothyroidism, cardiac
dysrhythmias, congestive heart failure, osteoporosis, paroxysmal atrial fibrillation,
gastroesophageal reflux disease, depression, anemia, atrophy and muscle wasting, and
abnormal gait. CMS Ex. 6, at 59. The MDS reflects that Resident 1 was cognitively
intact and independent for daily decision-making and she could speak, understand others,
and be understood. CMS Ex. 6, at 57. She had no negative behavioral symptoms and
was well-adapted to her environment emotionally. She required supervision and set-up
assistance for eating. CMS Ex. 6, at 58. The MDS shows that she was assessed as
having no limitation of range of motion in her neck, arms, or hands. CMS Ex. 6, at 59.
The MDS assesses Resident 1’s skin as being “desensitized to pain or pressure.” CMS
Ex. 6, at 60.

° “Credible evidence’ is evidence that is worthy of belief. Blacks Law Dictionary 596
(18th ed. 2004). The “weight of evidence” is the persuasiveness of some evidence
compared to other evidence. Jd. at 1625. Evidence that is not credible generally has no
probative value or weight. Evidence that is credible may or may not be given probative
value or weight based upon its comparison with other evidence of record.
An occupational therapist (OT) evaluated Resident 1 on March 26, 2007, and she was not
identified as at risk for handling hot liquids. CMS Ex. 6, at 29; Tr. at 232-33. Resident
1’s care plan, dated March 29, 2007, lists as a problem that she had activity of daily
living deficits due to a fractured foot, back pain, and muscle wasting. The care plan
states that she was capable of feeding herself with staff assistance for setup. An undated,
handwritten note on the care plan states that the resident wants drinks in Styrofoam cups
and that she sometimes wants staff to fill two cups with coffee. P. Ex. 32 at 21; CMS Ex.
6 at 5, 83. The care plan does not list an intervention to address a request by the resident
for more than one cup of coffee or other hot liquid. P. Ex. 32, at 22-3; CMS Ex. 6, at 6-7,
84-5.

It is undisputed that on April 8, 2007, Resident 1 had a Styrofoam cup of hot water and,
when she attempted to pour the water on her cereal, she spilled the water on her left leg
and abdomen. The record shows that ice was applied and the resident’s physician was
immediately called. He ordered that ice be continued for twenty-four hours. The
evidence shows that Resident 1’s husband was also called. Blisters subsequently formed.
The physician was called about the blisters, and the evidence shows that at 3:00 p.m. on
April 9, 2007, staff was waiting for a call-back from the physician for a treatment order
for the blisters. The husband was called again. The evidence shows that at 3:40 p.m. on
April 11, 2007, orders were received from the physician to apply Silvadene cream twice
per day to the blisters on her abdomen and thigh. The husband was again notified. On
April 12, 2007, the physician ordered that the Silvadene be discontinued due to allergies
and that ice be used as necessary. Nurse’s notes for April 14, 2007 show that a blister
had opened. On April 15, 2007, a new order was received for Bactroban three times per
day for seven days, and the physician was scheduled to see the resident in his office.
Resident 1 went to the physician’s office on April 16, 2007, and he sent the resident to
the hospital for possible cellulitis related to the blisters on her abdomen. CMS Ex. 6, at
19-21, 24, 36, 40, 48, 73-76; P. Ex. 32, at 34-36, 47-48, 64, 77-78, 84, 86-88. Resident 1
was discharged from the hospital on May 3, 2007. The discharge summary reflects final
diagnoses that include first and second degree burns to the lower abdominal wall and left
thigh with secondary cellulitis, a bacterial infection of the skin.’ P. Ex. 32, at 29-32.

7 Donald R. Frey, MD, opined that there was no evidence of cellulitis. His opinion is

outweighed by the discharge summary. Resident 1 was not his patient, and the evidence
shows that he did not examine the resident at the pertinent time. Tr. at 126-33, 157.
Petitioner’s wound care expert, Mary Malone, RN, also opined that she observed no
cellulitis when she examined the wounds on April 16, 2007. Tr. at 306-21. I do not find
that opinion weighty considering my discussion with RN Malone on the record at
hearing. I find more weighty the discharge summary.

Resident 4, a female, was 82 years old at the time of the survey. P. Ex. 33, at 1. Resident
4’s MDS, with an assessment reference date of January 22, 2007, lists the following
diagnoses: diabetes; hypothyroidism; arthritis; osteoporosis; seizure disorder; depression;
cataracts; glaucoma; allergies; and polyuria. In addition, she had a colostomy. The MDS
reflects that Resident 4 had visual limitations, as she could read large print but not regular
printing in books and newspapers. She did not wear glasses* and had modified
independence for daily decision-making. She usually understood others and could be
understood, and she displayed some symptoms of depression, but her mood could be
easily altered. She had some socially inappropriate behaviors, but she was adapted to her
environment. She was assessed as independent for eating but required set-up from staff.
She had no limitations in her range of motion, and her skin was assessed as being
desensitized to pain or pressure. P. Ex. 33, at 16-19, 30.

There is no dispute that on February 7, 2007, at about 6:30 p.m., Resident 4 spilled coffee
on her right arm. A nurse’s note states that the resident’s right arm was red, there were
no blisters or open areas, the resident denied any pain, and staff would monitor her for the
next seventy-two hours. P. Ex. 33, at 54, 90; CMS Ex. 9, at 4. An incident report dated
February 7, 2007 by the person preparing the report and signed by the DON on February
10, 2007, states that the physician was contacted at 10:30 p.m. on February 7, 2007 by
facsimile and that a message was left for the resident’s family member at 6:50 p.m. CMS
Ex. 9, at 14. The next nurse’s note is dated February 10, 2007 at 9:15 a.m. The nurse’s
note states that the resident complained of pain on her right arm, and a one centimeter by
one centimeter scabbed wound with red area around the wound was observed on her right
arm. The nurse’s note states that the resident’s physician was informed of the wound,
and a telephone order was received for triple antibiotic ointment with covering for
protection. The note states that the resident’s grandson was called and that staff would
continue to monitor the resident. CMS Ex. 9, at 14; P. Ex. 33, at 54. The physician’s
order in evidence is actually dated February 11, 2007. CMS Ex. 9, at 7-8, 36; P. Ex. 33,
at 62, 83, 87. A weekly wound assessment dated February 14, 2007, indicates that the
wound was healing. The assessment characterized the wound as a burn on the right wrist
but indicates that it was acquired on February 11, 2007. P. Ex. 33, at 84. The wound was
characterized as healed by March 3, 2007. CMS Ex. 9, at 8.

® A Resident Assessment Protocol (RAP) worksheet for visual function dated January
22, 2007 and the resident’s care plan dated January 22, 2007, show that Resident 4 did
have and used glasses. P. Ex. 33, at 39, 44; CMS Ex. 9, at 13.
10

(b) Analysis.
Section 483.10(b)(11)(i) of 42 C.F.R. entitled “Resident rights” requires:

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

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

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

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

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

The regulation does not allow a facility to pick and choose whom to notify and whom to
consult. Rather, it requires that the facility immediately inform the resident, consult the
physician, and notify the resident’s legal representative or interested family member. The
regulatory requirement is clearly stated — a facility “must immediately . . . consult with
the resident’s physician” when any of the four triggering events occur. 42 C.F.R. §
483.10(b)(11) (emphasis added). The requirement is not discretionary, and it requires
more than merely informing or notifying the physician. The preamble to the final rule
indicates the drafters’ specific intention that the facility should “inform” the resident of
the changes that have occurred but should “consult with the physician about actions that
are needed.” 56 Fed. Reg. 48,826, 48,833 (Sept. 26, 1991). Thus, the requirement of the
regulation to consult means more than to simply notify. Consultation requires a dialogue
with the resident’s physician as to what actions are needed. It is not enough to merely
notify the physician of the resident’s change in condition, nor is it enough to leave just a
message for the physician. The facility must provide the physician with all the
information necessary to properly assess any changes to the resident’s condition and what
course of action is necessary.
11

The regulation also requires consultation “immediately” upon discernment of a change in
condition of the resident. The use of the term “immediately” in the regulatory
requirement indicates that consultation is expected as soon as the change is detected. It
does not mean that the facility can wait hours or days before consulting with the
physician. The preamble to the final rule indicates that the proposed rule originally
granted the facility up to twenty-four hours in which to notify the resident’s physician
and the legal representative or family. However, after the receipt of comments that time
is of the essence in such circumstances, the final rule amended that provision to require
that the physician and legal representative or family be consulted and notified
immediately. 56 Fed. Reg. at 48,833. The word “immediately” recognizes that a delay in
such situations could result in a situation where a resident is beyond recovery or dies.
Magnolia Estates Skilled Care, DAB No. 2228, at 8 (2009). In balancing the relative
inconvenience to a physician and the facility staff to consult about a resident’s change in
condition with the possibility for dire consequences to the resident if the physician is not
consulted, any inconvenience certainly is inconsequential and outweighed by the
potential for resident harm. Therefore, the regulatory requirements make inconsequential
any inconvenience to the resident’s physician or to the facility staff when compared to the
protection and facilitation of the rights of the resident. 56 Fed. Reg. at 48,834.

I conclude based upon the evidence before me that, on April 14, 2007, Petitioner’s staff
failed to consult with the treating physician for Resident 1, immediately after discovering
that the blisters had opened with discharge and that there was reddening of the skin,
indicating that a change of treatment might be required.

The evidence shows that Resident | spilled a cup of hot water on her left leg and
abdomen on April 8, 2007. Ice was applied to the burns. Her physician was called, and
he ordered application of ice for twenty-four hours. CMS Ex. 6, at 20, 73-74. A nurse’s
note at 2:45 a.m. on April 9, 2007, shows that blisters on the abdomen and thigh had
formed. A nurse’s note at 3:00 p.m. on April 9, 2007 shows that staff was waiting for the
physician to call with new orders. The time the physician was called is not indicated. A
nurse’s note dated April 11, 2007 at 3:40 p.m. shows that the physician called back with
orders to apply Silvadene cream to the blisters twice per day. However, the Silvadene
was discontinued on April 12 at 1:00 p.m. due to a possible allergy. The nurse’s note at
1:15 p.m. on April 12 shows that the blisters were still closed, there was no reddening
around the site, there was tenderness to touch, and the resident’s pain medication was
effective. CMS Ex. 6, at 74-75; Tr. at 247-48. These facts show no violation of 42
C.F.R. § 483.10(b)(11)(i).

The evidence shows however, that at 8:00 a.m. on April 14, 2007, Resident 1 complained
of pain, and she was given pain medication. At 9:30 a.m. on April 14, staff noted a 3.7
centimeter open blister, with redness around the blister. At 3:00 p.m. on April 14, the
resident was given more pain medication. Resident 1 expressed concern about her skirt
sticking to the blisters on her thigh. A Telfa non-stick dressing was applied. The
12

blistered areas were noted to be red in color with no drainage, but an old drainage stain
was found on a pillow case. At 9:00 p.m. on April 14, the resident was given another
pain pill. Not until 1:30 p.m. April 15, 2007 is there a note that staff received orders to
use an antibiotic ointment for seven days and that the physician directed that the resident
be brought to his office for examination. The note also indicates that the blister on the
abdomen was bigger and that there was dead tissue from the wound. CMS Ex. 6, at 75-
76. The complaint of pain requiring administration of pain medication and the redness
around the open blister at 9:30 a.m. on April 14 indicated that there was a potential need
for a significant change of treatment within the meaning of 42 C.F.R. §
483.10(b)(11)(i)(C) that triggered the obligation to immediately consult with the
physician. According to Petitioner’s own records, the consultation did not occur until
1:30 p.m. on April 15, 2007, more than twenty-four hours later. I conclude that the
consultation was not immediate.’ Petitioner has not rebutted the inference triggered by
its records that no immediate consultation was accomplished. Accordingly, I conclude
that Petitioner violated 42 C.F.R. § 483.10(b)(11)(i) in the case of Resident 1. The
evidence shows that Resident | suffered actual harm in the form cellulitis to the abdomen
with pain. CMS Ex. 6, at 76; P. Ex. 32, at 29-32.

I do not find a violation occurred in the case of Resident 4. The resident spilled coffee on
her right arm on February 7, 2007 sometime around 6:00 p.m. with redness observed but
no blisters or complaints of pain. P. Ex. 33, at 54; CMS Ex. 9, at 4. The evidence does
not show that at that time there was a potential for physician intervention, a significant
change in the resident’s condition, or a need to significantly alter treatment. Accordingly,
the regulatory requirement to immediately consult the physician was not triggered. On
February 10, 2007 at about 9:15 a.m., the resident complained of pain on her right arm,
and a scab with a surrounding red area was observed. The evidence shows the physician
was immediately called, and a new order was subsequently documented. P. Ex. 33, at 54;
CMS Ex. 9, at 4. Based upon the evidence before me, the regulatory requirement to
immediately consult the physician was satisfied in the case of Resident 4. Accordingly, I
conclude that there was no violation related to Resident 4.

° Dr. Frey opined that staff timely and appropriately contacted Resident 1’s physician.
Tr. at 133. I do not consider that opinion weighty with respect to the issue of whether or
not the consultation by staff with physician satisfied the requirements of the regulation.
Dr. Frey was not qualified to render legal opinions, and the ultimate issue is for me, not
an expert witness, to decide.
13

2. Petitioner violated 42 C.F.R. § 483.25(h)(2) (Tag F324).

The surveyors allege in the SOD that Petitioner violated 42 C.F.R. § 483.25(h)(2),
because Petitioner failed to: (1) evaluate resident safety following repeated occurrences
of resident burns from hot liquids involving Residents 1, 3, and 4; (2) evaluate for safety
with hot liquids, Residents 6, 7, 8, and 9, who consumed fluids independently or with
supervision; and (3) implement interventions to prevent skin tears for Resident 5. CMS
Ex. 2, at 21.

(a) Facts.

(i) Residents 1, 3, and 4 suffered burns from spilled hot
liquids.

There is no dispute that all three residents spilled hot liquid on themselves while using
Styrofoam cups. The facts related to the burns suffered by Residents 1 and 4 are
discussed under Tag F157. The SOD alleges that Resident 3 suffered a burn when she
poured hot tea onto her left thigh while in the main dining room of the facility. CMS Ex.
2, at 32. The evidence shows that the resident spilled hot tea from a Styrofoam cup onto
her left thigh while in the dining room for dinner at about 6:30 p.m. on April 8, 2007.
CMS Ex. 8, at 30, 32. Staff documented that the spill caused some redness but no pain,
and the next day the redness was gone, there was no pain or discomfort, and staff decided
to stop charting the incident. CMS Ex. 8, at 24, 30, 33.

(ii) Residents 6, 7, 8 and 9 did not suffer burns, but surveyors
observed that the residents used Styrofoam cups.

The SOD alleges that on May 2, 2007, a surveyor observed that Resident 6 was given a
Styrofoam cup from which she drank. The surveyor also observed that Resident 6 had
several adaptive cups with lids on the bedside table. Resident 6 had physician orders
dated February 26, 2007 and April 16, 2007, that required that she use a cup with handle,
lid, and straw at meals. CMS Ex. 2, at 26-27; CMS Ex. 11, at 3; P. Ex. 35, at 4, 11.
Nutrition Assessments dated October 27, 2006, February 5, 2007, and April 17, 2007,
assessed the resident as requiring cups with handles, lids, and straws for feeding. CMS
Ex. 11, at 7. Her nutrition care plan, dated March 11, 2007, required the use of cups with
handles, lids, and straws. CMS Ex. 11, at 16-17.

Resident 7 was assessed as requiring setup help from staff and supervision while eating.
P. Ex. 36, at 4. The SOD alleges that the surveyor observed a family member of Resident
7 obtain a Styrofoam cup of coffee, and, ten minutes later, the surveyor observed that
Resident 7 had the cup of coffee and no staff or family member was present. CMS Ex. 2,
at 28-29.

14

The SOD alleges that a surveyor observed Resident 8 on May 2, 2007 with coffee in a
Styrofoam cup, and no staff member was present. CMS Ex. 2, at 29. The SOD alleges
that Resident 8’s care plan required that Resident 8 have assistance with eating.
However, I find no evidence that the resident’s requirement for assistance with feeding
was actually documented in a care plan. CMS Ex. 2, at 29; CMS Ex. 13, at 5; P. Ex. 37,
at 21. Resident 8’s MDS assessments with reference dates of March 18, 2007 and April
3, 2007, assessed her as requiring limited physical assistance of one staff member for
eating. P. Ex. 37, at 6-7, 15-16.

A surveyor observed Resident 9 at 11:42 a.m. on May 2, 2007, with coffee in a
Styrofoam cup, while an unused coffee mug sat on the table. No staff member was with
Resident 9, and Resident 9 reported that staff gave him the coffee in the Styrofoam cup.
CMS Ex. 2, at 3. Resident 9’s MDS with an assessment reference date of March 31,
2007, shows that he was assessed as independent for eating with setup assistance from
staff. P. Ex. 38, at 1-2.

(iii) Resident 5 was observed without her care-planned Geri
Sleeves.

The SOD alleges that, at 10:30 a.m. on May 3, 2007, the surveyor observed Resident 5
without Geri Sleeves on her arms. The surveyor observed the resident again at 11:15
a.m. on May 3, 2007, and the resident was not wearing Geri Sleeves. CMS Ex. 2, at 34;
Tr. at 86-87. Resident 5 was assessed in October 2006 as needing to wear Geri Sleeves at
all times to prevent skin tears. CMS Ex. 10, at 28, 39. Resident 5’s skin care plan dated
October 8, 2007, as updated through April 5, 2007, included an intervention for the
resident to wear Geri Sleeves at all times to prevent skin tears. CMS Ex. 10, at 36. On
March 4, 2007, Resident 5 experienced a skin tear on her left forearm while she was not
wearing her Geri Sleeves. CMS Ex. 10, at 40-42. A nurse’s note dated February 4, 2007,
also shows that the resident suffered a skin tear, but the location of the tear and whether
or not the resident was wearing Geri Sleeves is not shown by the evidence before me. P.
Ex. 39, at 22. Petitioner does not dispute that Resident 5 did not have Geri Sleeves on
her arms when the surveyor observed her. P. Br. at 22-23.

(b) Analysis.

The general quality of care regulation, 42 C.F.R. § 483.25, requires that a facility ensure
that each resident receives the necessary care and services to attain or maintain the
resident’s highest practicable physical, mental, and psychosocial well-being, in
accordance with the resident’s comprehensive assessment and plan of care that the
resident’s care planning team developed in accordance with 42 C.F.R. § 483.20. The
quality of care regulations impose specific obligations upon a facility related to accident
hazards and accidents.
15

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.

42 C.F.R. § 483.25(h). The SOM, as amended in August 2007, instructs surveyors that
the intent of 42 C.F.R. § 483.25(h)(1) and (2) is “to ensure the facility provides an
environment that is free from accident hazards over which the facility has control and
provides supervision and assistive devices to each resident to prevent avoidable
accidents.” The facility is expected to: identify, evaluate, and analyze hazards and risks;
implement interventions to reduce hazards and risks; and monitor the effectiveness of
interventions and modify them when necessary. SOM, app. PP, Guidance to Surveyors
for Long Term Care Facilities, F323, Quality of Care (Rev. 27; eff. Aug. 17, 2007).

The Board has provided interpretative guidance for adjudicating alleged violations of 42
C.F.R. § 483.25(h)(1):

The standard in section 483.25(h)(1) itself - that a facility
“ensure that the environment is as free of accident hazards as
possible” in order to meet the quality of care goal in section
483.25 -- places a continuum of affirmative duties on a
facility. A facility must determine whether any condition
exists in the environment that could endanger a resident’s
safety. If so, the facility must remove that condition if
possible, and, when not possible, it must take action to protect
residents from the danger posed by that condition. [Footnote
omitted.] Ifa facility has identified and planned for a
hazard and then failed to follow its own plan, that may be
sufficient to show a lack of compliance with [the]
regulatory requirement. In other cases, an ALJ may need to
consider the actions the facility took to identify, remove, or
protect residents from the hazard. Where a facility alleges (or
shows) that it did not know that a hazard existed, the facility
cannot prevail if it could have reasonably foreseen that an
endangering condition existed either generally or for a
particular resident or residents.

Maine Veterans’ Home — Scarborough, DAB No. 1975, at 6-7 (2005) (emphasis added).
The Board has also explained the requirements of 42 C.F.R. § 483.25(h)(2) in numerous

decisions. Golden Living Ctr. — Riverchase, DAB No. 2314, at 7-8 (2010); Eastwood
Convalescent Ctr., DAB No. 2088 (2007); Liberty Commons Nursing and Rehab -
16

Alamance, DAB No. 2070 (2007); Century Care of Crystal Coast, DAB No. 2076
(2007), aff'd, 281 F. App’x 180 (4th Cir. 2008); Golden Age Skilled Nursing & Rehab.
Ctr., DAB No. 2026 (2006); Estes Nursing Facility Civic Ctr., DAB No. 2000 (2005);
Northeastern Ohio Alzheimer’s Research Ctr., DAB No. 1935 (2004); Woodstock Care
Ctr., DAB No. 1726 (2000), aff'd, 363 F.3d 583 (6th Cir. 2003). Section 483.25(h)(2)
does not make a facility strictly liable for accidents that occur; however, it does require
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
arm from accidents. Woodstock Care Ctr. v. Thompson, 363 F.3d at 589 ([A] SNF must
take “all reasonable precautions against residents’ accidents.”). A facility is permitted the
lexibility to choose the methods of supervision it uses to prevent accidents, but the
chosen methods must be adequate under the circumstances. Whether supervision is
“adequate” depends in part upon the resident’s ability to protect himself or herself from
arm. Jd. Based on the regulation and the cases in this area, CMS meets its burden to
show a prima facie case if the evidence demonstrates that the facility failed to provide
adequate supervision and assistance devices to prevent accidents, given what was
reasonably foreseeable. Alden Town Manor Rehab. & HCC, DAB No. 2054, at 5-6, 7-12
(2006). An “accident” is an unexpected, unintended event that can cause a resident
bodily injury, excluding adverse outcomes associated as a direct consequence of
treatment or care (e.g., drug side effects or reactions). SOM, app. PP, Tag F323;
Woodstock Care Ctr., DAB No. 1726, at 4.

I conclude that Petitioner violated 42 C.F.R. § 483.25(h)(2) by failing to provide
Residents 5 and 6 with care planned assistive devices and by failing to provide Residents
7 and 8 with supervision or assistance that they were assessed to require.

There is no dispute that Resident 5 was assessed in October 2006 to need Geri Sleeves at
all times to prevent skin tears and that her care plan required that she wear Geri Sleeves
at all times. CMS Ex. 10, at 28, 36, 39. Petitioner’s clinical records for Resident 5
clearly show that when she was not wearing her Geri Sleeves on March 4, 2007, she
suffered a skin tear on her left forearm. CMS Ex. 10, at 40-42. Petitioner cannot
credibly argue in the face of this evidence that it was not foreseeable that if Resident 5
did not wear Geri Sleeves she was at risk for an accidental skin tear. Petitioner assessed
and care planned the resident for Geri Sleeves, an assistive device, to prevent accidental
skin tears, and the surveyor’s observations that the resident was not wearing the Geri
Sleeves is a prima facie showing of a violation of 42 C.F.R. § 483.25(h)(2). A skin tear
is clearly actual harm. The evidence does not show that Resident 5 suffered actual harm
due to the absence of Geri Sleeves on May 3, 2007, and CMS does not charge Petitioner
for a violation based on the March 4, 2007 skin tear. The evidence is sufficient to show,
however, that Resident 5 was clearly at risk for more than minimal harm due to the
increased risk for accidental skin tears when she was not wearing the Geri Sleeves.
Petitioner has not rebutted the prima facie showing.

17

There is no dispute that Resident 6 had a physician’s orders that required that she use a
cup with handle, lid, and straw. CMS Ex. 2, at 26-27; CMS Ex. 11, at 3; P. Ex. 35, at 4,
11. Furthermore, she was assessed as requiring cups with handles, lids, and straws for
feeding. CMS Ex. 11, at 7. Resident 6’s nutrition care plan, dated March 11, 2007,
required the use of cups with handles, lids, and straws. CMS Ex. 11, at 16-17.
Nevertheless, it is undisputed that, on May 2, 2007, a surveyor observed Resident 6
drinking from a Styrofoam cup while several assistive devices, adaptive cups with lids,
sat on the bedside table. The failure to comply with Resident 6’s care plan placed the
resident at risk for an accidental injury due to a spill of hot liquid from a cup without a
lid, handles, and straw. The evidence shows that other residents did suffer burns from hot
liquids spilled for Styrofoam cups, which were commonly used throughout the facility.

A burn, first, second, or third degree, is actual harm. Tr. at 135-36. Resident 6 is not
alleged to have suffered actual harm on May 2, 2007, but I find the evidence shows that
she was at risk for more than minimal harm. I conclude that the example of Resident 6 is
a prima facie showing of a violation of 42 C.F.R. § 483.25(h)(2) that Petitioner has failed
to rebut.

There is no dispute that Resident 7 was assessed as requiring setup help from staff and
supervision while eating. P. Ex. 36, at 4. However, the surveyor observed a family
member of Resident 7 obtain a Styrofoam cup of coffee, and, ten minutes later, the
surveyor observed that Resident 7 had the cup of coffee and no staff or family member
was present to provide supervision. CMS Ex. 2, at 28-29. Thus, I find that Resident 7 did
not receive the supervision that he required, which placed him at risk for an accidental
burn from hot coffee spilled from the Styrofoam cup. The evidence shows that three
residents suffered burns from spills of hot liquid from Styrofoam cups and burns are
actual harm. Thus, | find that Resident 7 was a risk for more than minimal harm though
there was no actual harm. I conclude that there is a prima facie showing of a violation of
42 C.F.R. § 483.25(h)(2) that Petitioner has failed to rebut.

Resident 8’s MDS’s with assessment reference dates of March 18, 2007 and April 3,
2007, assessed her as requiring limited physical assistance of one staff member for
eating. P. Ex. 37, at 6-7, 15-16. Ido not have evidence that Petitioner ever adopted a
care planned intervention to address Resident 8’s need for physical assistance with
eating. The SOD alleges that Resident 8 was observed by a surveyor on May 2, 2007
with coffee in a Styrofoam cup and no staff member was present. CMS Ex. 2, at 29. I
find that Resident 8 was not receiving the assessed assistance and/or supervision
necessary while drinking from a Styrofoam cup. I find that there was a risk for more than
minimal harm without actual harm for the reasons already discussed. I conclude that the
evidence related to Resident 8 amounts to a prima facia showing of a violation of 42
C.F.R. § 483.25(h)(2) that Petitioner has failed to rebut.
18

I conclude, based upon my application of the law to the facts, that the examples cited in
the SOD related to Residents 1, 3, 4, and 9 do amount to violations of 42 C.F.R. §
483.25(h)(2).

Resident 9 was assessed as independent for eating with setup assistance from staff. P.
Ex. 38, at 1-2. There is no evidence that the use of a Styrofoam cup for hot liquids by a
resident is inherently dangerous. The evidence does not show that Resident 9 was at risk
to spill a hot liquid from a cup due to some impairment or defect that he suffered. The
mere fact that Resident 9 was observed by a surveyor with coffee in a Styrofoam cup, an
unused coffee mug on the table, with no staff member present (CMS Ex. 2, at 30), does
not amount to a prima facie showing that Resident 9 was not receiving necessary
supervision or assistance.

Resident 4 experienced a minor burn due to a spill from a Styrofoam cup on February 7,
2007. I have no evidence of any prior instance of accidental spills from Styrofoam or
other types of cups that caused harm or posed harm to any resident. Thus, I have no basis
to infer that Petitioner was on notice, or should have foreseen, that hot liquids in
Styrofoam cups posed a risk for accidental injury to residents who were assessed as able
to eat independently, with or without setup assistance. There is no evidence that shows,
or from which I may infer, that the assistance and supervision provided to residents was
not sufficient to protect them from accidental injury even when using a Styrofoam cup for
hot liquids. Resident 1 and 3 experienced spills on the same day, April 8, 2007. For the
reasons already stated for Resident 4, I conclude that, on April 8, 2007, the evidence does
not show that Petitioner knew or should have foreseen that there was a risk for accidental
injury from serving residents hot liquids in Styrofoam cups if they were otherwise
assessed as able to eat independently. However, when the spills occurred on April 8,
2007, I conclude that Petitioner could not ignore or overlook that there was some
potential for accidental injury due to the use of Styrofoam cups or other open cups for hot
liquids, at least with some residents. As of April 8, 2007, Petitioner should have:
foreseen the risk for accidental injury; undertaken to assess which residents were
susceptible; implemented interventions to mitigate or eliminate the risk; and assessed the
effectiveness of its interventions and implemented new more effective interventions if
necessary. The evidence before me shows that, between April 8, 2007 and the date of the
survey, Petitioner did not take reasonable steps to mitigate or eliminate the risk for
accidental injury to its residents from the use of Styrofoam or other cups without lids, by
supervision, assistance devices, or other appropriate interventions. Tr. at 202-03; 238-39;
294.

3. There is a basis for the imposition of an enforcement remedy.

4. The immediate jeopardy determination is not subject to review in
this case, as the amount of PICMP is not affected by whether or not
there is immediate jeopardy.
19

5. The scope and severity assessed by the surveyors is not subject to
review.

6. Whether or not a violation of a statutory or regulatory participation
requirement poses more than minimal harm must be determined as
part of deciding whether CMS has made a prima facie showing that
Petitioner was not in substantial compliance with program
participation requirements.

7. It is my duty to make a de novo determination of a reasonable
enforcement remedy to be applied within the parameters established
by the regulations.

8. A PICMP of $8,000 is not reasonable, but a PICMP of $4,000 is
reasonable.

I have already acknowledged the regulatory provisions that limit my authority to review
the determination that there was immediate jeopardy or the scope and severity
determination of the agency. In this case, the only enforcement remedy at issue is the
$8,000 PICMP. The regulations establish only a single range for PICMPs. The presence
or absence of immediate jeopardy does not automatically escalate the amount of PICMP
as it does in the case of CMP imposed for a period of days. The scope and severity
determination does not affect the limitation on authority to conduct a NATCEP or the
amount of the CMP imposed in this case. Accordingly, the scope and severity
determination and declaration of immediate jeopardy are not reviewable. However, it is
necessary for me to review and determine whether or not any of the deficiencies posed
more than minimal harm for purposes of deciding whether CMS has shown Petitioner
was not in substantial compliance. My determinations in that regard were discussed in
the analysis of each deficiency subject to my review in this case. As discussed hereafter,
it is also necessary for me to consider the severity of each deficiency in assessing a
reasonable enforcement remedy.

I have concluded that Petitioner violated 42 C.F.R. §§ 483.10(b)(11) (Tag F157) and
483.25(h)(2) (Tag F324). I have also concluded that each violation posed a risk for more
than minimal harm to facility residents. Thus, I conclude that Petitioner was not in
substantial compliance with program participation requirements, and there is a basis for
the imposition of an enforcement remedy. Ifa facility is not in substantial compliance
with program requirements, CMS has the authority to impose one or more of the
enforcement remedies listed in 42 C.F.R. § 488.406, including a CMP. CMS may impose
a per day CMP for the number of days that the facility is not in compliance or a PICMP
for each instance that a facility is not in substantial compliance, whether or not the
deficiencies pose immediate jeopardy. 42 C.F.R. § 488.430(a). The minimum amount
20

for a PICMP is $1,000 and the maximum is $10,000. 42 C.F.R. § 488.438(a)(2). CMS
elected to impose a PICMP in this case.

When I conclude that there is a basis for the imposition of an enforcement remedy and
the remedy proposed is a CMP, my authority to review the reasonableness of the CMP is
limited by 42 C.F.R. § 488.438(e). The limitations are: (1) I may not set the CMP at
zero or reduce it to zero; (2) I may not review the exercise of discretion by CMS in
electing to impose a CMP; and (3) I may only consider the factors specified by 42 C.F.R.
§ 488.438(f) when determining the reasonableness of the CMP amount. Therefore, the
following factors specified at 42 C.F.R. § 488.438(f) must be considered: (1) the
facility’s history of non-compliance, including repeated deficiencies; (2) the facility’s
financial condition; (3) the seriousness of the deficiencies based upon the factors set forth
at 42 C.F.R. § 488.404(b) (the same factors CMS and/or the state were to consider when
setting the CMP amount); and (4) the facility’s degree of culpability, including but not
limited to the facility’s neglect, indifference, or disregard for resident care, comfort, and
safety and the absence of culpability is not a mitigating factor. The factors set forth in 42
C.F.R. § 488.404(b) include: (1) whether the deficiencies caused —— (a) no actual harm
but had the potential for minimal harm, (b) no actual harm with the potential for more
than minimal harm, but not immediate jeopardy, (c) actual harm that is not immediate
jeopardy, or (d) immediate jeopardy to resident health and safety; and (2) whether the
leficiencies are isolated, constitute a pattern, or are widespread. My review of the
reasonableness of the CMP is de novo and based upon the evidence in the record before
me. I am not bound to defer to the CMS determination of the reasonable amount of the
CMP to impose but my authority is limited by regulation as already explained. I am to
letermine whether the amount of any CMP proposed is within reasonable bounds
considering the purpose of the Act and regulations. Emerald Oaks, DAB No. 1800, at 10
(2001); CarePlex of Silver Spring, DAB No. 1683, at 14-16 (1999); Capitol Hill
Community Rehab. & Specialty Care Ctr., DAB No. 1629 (1997).

There is no evidence that Petitioner had a history of noncompliance. Petitioner has not
alleged to me that it cannot pay the PICMP and has presented no evidence of its financial
condition. Based upon the facts discussed above, I find that the deficiencies were serious
in that they posed a risk for actual harm. I am not persuaded that either of the

leficiencies posed a risk for serious harm or death considering the nature and extent of
the injuries suffered by Residents 1 and 4 and assuming that any burns caused by spilled
liquids from a Styrofoam or other uncovered cup were promptly and properly treated.
Petitioner is culpable for failing to recognize the risk for accidental injury to its residents
and to implement interventions to provide necessary assistance and supervision to
mitigate or eliminate the risk for accidental injury from spills of hot liquids from
uncovered cups.

Based upon my de novo review of the required regulatory factors, I conclude that a
PICMP of $8,000 is not reasonable. I conclude that a PICMP of $4,000 is a sufficient
21

enforcement remedy to encourage Petitioner to achieve and maintain substantial
compliance. Indeed, the evidence before me is undisputed that even during the survey
Petitioner was taking significant steps to perform assessments to identify residents at risk
for accidental injuries and to implement interventions to minimize or eliminate the risk,
including removing Styrofoam cups from the facility and prohibiting their use for
residents.

Il. Conclusion

For the foregoing reasons, I conclude that Petitioner was not in substantial compliance
with program participation requirements due to violations of 42 C.F.R. §§ 483.10(b)(11)
(Tag F157) and 483.25(h)(2) (Tag F324). There is a basis for the imposition of an
enforcement remedy. A PICMP of $8,000 is not a reasonable enforcement remedy, but a
$4,000 PICMP is reasonable.

/s/
Keith W. Sickendick
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division
Toni Lynn Spring
(OI 5-09-40353-9),
Petitioner
Vv.

The Inspector General.
Docket No. C-10-782
Decision No. CR2287

Date: November 22, 2010

DECISION

Petitioner, Toni Lynn Spring, asks review of the Inspector General’s (1.G.’s)
determination to exclude her for five years from participation in the Medicare, Medicaid,
and all federal health care programs under section 1128(a)(3) of the Social Security Act.
For the reasons discussed below, I find that the I.G. is authorized to exclude Petitioner
and that the statute mandates a minimum five-year exclusion.

I. Background

Petitioner is a registered nurse in the State of Indiana who was arrested and charged with
one felony count of possession of a legend drug, two felony counts of theft, three
misdemeanor counts of conversion, and one misdemeanor count of operating a vehicle
while intoxicated. I.G. Ex. 4; P. Ex. 1. On November 24, 2008, she pled guilty in an
Indiana State Court to felony drug possession and to misdemeanor operating

a vehicle while intoxicated. I.G. Ex. 5. The court accepted the pleas and entered
judgment against her on January 12, 2009. LG. Ex. 5; P. Ex. 2.
In a letter dated September 30, 2009,! the I.G. advised Petitioner that, because she had
been convicted of a felony offense related to fraud, theft, embezzlement, breach of
fiduciary responsibility or other financial misconduct in connection with the delivery of a
healthcare item or service, the I.G. was excluding her from participation in Medicare,
Medicaid, and all federal health care programs for a period of five years. CMS Ex. 1.
Section 1128(a)(3) of the Social Security Act (Act) authorizes such exclusion. LG. Ex. 1.

The parties agree that an in-person hearing is not required and that the matter may be
resolved based on written submissions. I.G. Br. at 7; P. Br. at 6. The parties have
submitted their principal briefs. The I.G. filed a reply brief. Petitioner filed a sur-reply,
and the I.G. responded to the sur-reply. The I.G. submitted nine exhibits (1.G. Exs. 1- 9).
Petitioner submitted eight exhibits (P. Exs. 1-8).

While not explicitly objecting to their admission, Petitioner argues that I.G. Exs. 7, 8, and
9 are hearsay and should not be considered. These documents are affidavits from Damon
L. Grove, an investigator with the Indiana Medicaid Fraud Control Unit, and Janet L.
Mason, LPN, Charge Nurse at Ben Hur Home, as well as a written statement that LPN
Mason provided to the Crawfordsville, Indiana Police Department. I note first that, even
under the Federal Rules of Evidence, a police report and witness affidavits would likely
be admissible. (In fact, LPN Mason’s declaration and statement contain virtually no
hearsay). In any event, I am not bound by the Rules of Evidence. With limited
exceptions (e.g. danger of unfair prejudice, confusion, undue delay), the regulations
instruct me to admit evidence that is relevant and material. 42 C.F.R. § 1004.17.
Because I find these documents relevant and material, I will admit them.

Nor do I sympathize with Petitioner’s complaint that, since she had no criminal trial, she
was unable to cross-examine these witnesses. These witnesses have now presented their
testimony, under oath, in these proceedings. Petitioner could have moved to cross-
examine them, if, in fact, she challenged any of the facts asserted in their statements. She
has not done so.

I admit into evidence I.G. Exs. 1-9 and P. Exs. 1-8.

IL. Issue

The sole issue before me is whether the I.G. has a basis for excluding Petitioner from
program participation. Because an exclusion under section 1128(a)(3) must be for a

minimum period of five years, the reasonableness of the length of the exclusion is not an
issue. Act § 1128(c)(3)(B); 42 C.F.R. § 1001.2007(a)(2).

' The letter was returned to the I.G., because its address was incorrect. I.G. Ex. 2. The
1.G. subsequently reissued the letter, and Petitioner timely filed her appeal.
II. Discussion

Petitioner must be excluded for five years, because she was
convicted of a felony related to fraud and theft in the
delivery of a healthcare item or service.”

Section 1128(a)(3) provides that an individual or entity convicted of felony fraud, theft,
embezzlement, breach of fiduciary responsibility, or other financial misconduct in
connection with the delivery of a health care item or service must be excluded from
participation in federal health care programs for a minimum of five years. See 42 C.F.R.
§ 1001.101(c). An offense is related to the delivery of an item or service under Medicare
or a state health care program if there is “a nexus or common-sense connection” between
the conduct giving rise to the offense and the delivery of the item or service. Andrew
Goddard, DAB No. 2032 (2006); Erik D. DeSimone, DAB No. 1932 at 3-4 (2004).

Petitioner concedes that she was convicted of a felony (P. Br. at 1, 2)* but argues that she
is not subject to exclusion, because the LG. has not established that her crime was
“related to” fraud, theft, embezzlement, breach of fiduciary responsibility, or other
financial misconduct in connection with the delivery of a health care item or service.
Petitioner points out that her sole felony conviction was for drug possession, which is
insufficient to justify exclusion under section 1128(a)(3). Although charged with drug
theft, Petitioner argues that unsubstantiated charges are insufficient to establish the
required common-sense connection between her conviction and fraud or theft in the
delivery of a healthcare item or service.

It is well-settled that the I.G. may rely on extrinsic evidence to explain the circumstances
underlying a conviction. The regulations specifically provide that evidence of “crimes,
wrongs, or acts other than those at issue in the instant case is admissible in order to show
motive, opportunity, intent, knowledge, preparation, identity, lack of mistake, or
existence of a scheme.” 42 C.F.R. § 1005.17(g). See Narendra M. Patel, DAB No. 1736
(2000); Tanya A. Chuoke, R.N., DAB No. 1721 (2000); Bruce Lindberg, D.C., DAB No.
1280 (1991).

While I agree with Petitioner that unsubstantiated charges, by themselves, are insufficient
to establish the necessary connection, here, extrinsic -- and admissible -- evidence

* I make this one finding of fact/conclusion of law.

* In a subsequent modification order, the court reduced the felony conviction to a
misdemeanor, but Petitioner concedes that she was nevertheless convicted of a felony
within the meaning of section 1128(a)(3). I.G. Ex. 6; P. Br. at 1; see 42 C.F.R. § 1001.2
(“Conviction means that . . . [a] judgment of conviction has been entered . . . regardless
of whether . . .[it] has been expunged or otherwise removed.”).
establishes that Petitioner was employed by a nursing home, Ben Hur Home, and that
drugs she possessed had been prescribed to residents of that facility. Specifically, in her
affidavit, LPN Mason states that she identified the drugs found in Petitioner’s possession,
and those drugs had been prescribed to named residents of the facility. LG. Ex. 8. I find
these unrebutted facts sufficient to create a nexus between Petitioner’s crime and theft of
a healthcare item or service.

Petitioner also points out that state authorities have allowed her to retain her nursing
license. While the state’s actions may have affected the minimal length of her exclusion,
it does not supersede federal law (as Petitioner acknowledges), and federal law mandates
a five-year exclusion.

IV. Conclusion

For these reasons, I conclude that the I.G. properly excluded Petitioner from participation
in Medicare, Medicaid, and all federal health care programs, and I sustain the five-year
exclusion.

/s/
Carolyn Cozad Hughes
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division
Washington County Life Savings Crew, Inc.,
(NPI: 1295723658),

Petitioner
Vv.

Centers for Medicare & Medicaid Services.
Docket No. C-10-838
Decision No. CR2285

Date: November 19, 2010

DECISION REMANDING CASE

I deny the motion for summary disposition of the Centers for Medicare & Medicaid
Services (CMS), because I find that the record is not adequate to support a final
resolution. I therefore dismiss without prejudice and remand the case so that either CMS
or its contractor, TrailBlazer Health Enterprises, Inc. (TrailBlazer), may develop the
record and issue a reconsideration decision based on the facts.

I. Background

By letter dated July 2, 2010, Washington County Life Savings Crew, Inc. (Petitioner)
appealed the decision of CMS to revoke Petitioner’s Medicare enrollment and Medicare
billing privileges. Hearing Request (HR). With its hearing request, Petitioner attached
various documents including a copy of a CMS-855B Medicare enrollment application
and correspondence between Petitioner and TrailBlazer.

On August 19, 2010, CMS filed its Exchange of Evidence/Argument and Motion for
Summary Disposition (CMS MSD) in this matter. CMS proffered five exhibits (CMS
Exs. 1-5), which I admit in the absence of objection. Petitioner responded to the CMS
motion (P. Response) on October 7, 2010. Petitioner also enclosed other documents and
a list of exhibits referencing these documents as its Exhibits 1-13. CMS did not object to
any of the materials submitted by Petitioner. I therefore admit all documents submitted
into evidence for this decision.

In this case, the following facts are undisputed. On September 28, 2009, TrailBlazer sent
Petitioner a notice letter stating that 42 C.F.R. § 424.515 —

requires Medicare providers to verify accuracy of their enrollment
information every five years in order to maintain Medicare billing
privileges. Please submit a completed CMS 855 application within 60
calendar days from the date of this letter to avoid revocation of your
Medicare billing privileges. This is the only notice you will receive
regarding this request.

CMS Ex. 1, at 1 (emphasis in original). This notice letter was sent to Petitioner at 65
Park St., Abingdon, VA 24210. Id.

Subsequently, on December 18, 2009, TrailBlazer mailed a document with the subject
line of “Notice of Possible Revocation of Medicare Billing Privileges” to Petitioner at the
same address in Abingdon, VA. CMS Ex. 2. The document stated that

42 C.F.R. § 424.535(a)(6) provides that if a —

provider or supplier fails to furnish complete and accurate information and
all supporting documentation within 60 [] calendar days of the provider or
supplier’s notification from CMS, the Medicare billing [] privileges may be
revoked. TrailBlazer requested revalidation on 9/28/2009, but has not
received a response to our original request.

CMS Ex. 2, at 1.

Then, on February 9, 2010, TrailBlazer wrote Petitioner that its Medicare billing
privileges were revoked effective January 17, 2010. CMS Ex. 3. This letter advising
Petitioner of its revocation due to noncompliance with the enrollment requirements of 42
C.F.R. § 424.515 was addressed to Petitioner at P.O. Box 290184, Wethersfield, CT
06129. Id. This different address for Petitioner was a “correspondence/pay-to” address
that CMS acknowledges that it had in its files. CMS Ex. 5, at 4 8.

The February 9, 2010 letter advised that, if Petitioner believed it could correct the
deficiencies, Petitioner could submit a corrective action plan (CAP) within 30 days.
CMS Ex. 3. In addition, the letter stated that if Petitioner believed that the determination
was not correct, it could request reconsideration before a contractor hearing officer within
60 days. Id.

On April 9, 2010, Petitioner submitted a Part B CAP Request Form. HR; P. Response.
Petitioner contends that it was advised —

to submit the application along with a copy of the letter and postmarked
envelop and request an appeal by completing the Part B CAP Request Form.
Explaining that the request for revalidation was received after the 30 day
return date.

P. Response.
On the Part B CAP Request Form Petitioner stated —

IN S/W PE REP MIKE ON 2/17 @ 214 IN REGARDS TO REVOKE LTR
RECEIVED. HE STATED TO SEND IN THIS APPEAL ALONG WITH WITH
THE REQUEST FOR REVALIDATION THAT WAS RECEIVED

ON 02/02. THE REQUEST DTD 12/18/09 WAS MAILED TO THE PHYSICAL
LOCATION AND RETURNED B/C THAT IS NOT THEIR
CORRESPONDENCE ADDRESS. THE ENVELOP WAS HAND WRITTEN
WITH THE CORRECT ADDRESS, P.O. BOX 290184 (POST MARKED
01/26/2010) AND REC’D ON 02/02 ... AFTER THE 30DAY/60DAY
WARNING. NOTICES PRIOR TO THIS WERE NOT REC’D IE. LTR REF.
DATE 09/14 AND 09/28 IN BOTH NOTICES. I’ VE ATTACHED THE
APPLICATION (855B) ALONG WITH EFT SET-UP, SUPPLIER
AGREEMENT AND W9 AS REQUESTED BY MIKE. REVOKING THE
PROVIDER NUMBER WILL CREATE A HARDSHIP ON THIS VOLUNTEER
ORGANIZATION AND I HOPE DUE TO THE DISCREPENCIES IN THE
ADDRESS THAT YOU WILL CONSIDER REACTIVATING THE PROVIDER
NUMBER....

CMS Ex. 4. Petitioner thus asserts in this statement, as it does before me, that it did not
receive the September revalidation request or the December warning letter because these
documents were not sent to the correspondence address of record.

CMS construed the form submitted by Petitioner on April 9, 2010 as a CAP request and
returned it to Petitioner without action on May 6, 2010 because CMS determined it was
received past the 30 calendar days allotted for such submission. CMS MSD at 2-3. CMS
asserts that Petitioner never submitted a reconsideration request (but does not ask that the
appeal be dismissed). Jd. at 3. CMS argued that, in any case, Petitioner’s revocation
must stand because “the credible evidence, which includes the undisputed material facts,
supports that Petitioner was not in compliance with the applicable requirements,” so that
CMS is “entitled to summary judgment.” Jd. at 7.

IL. Issue, Findings of Fact, Conclusions of Law
A. Issue

The sole issue presented by the parties in this case is whether the undisputed facts
demonstrate that the revocation of Petitioner’s Medicare billing privileges was legally
authorized.

B. Applicable Standard

CMS seeks summary disposition in the nature of summary judgment. The Departmental
Appeals Board (Board) stated the standard for summary judgment as follows.

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

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

Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300, at 3 (2010) (citations omitted).
The role of an ALJ in deciding a summary judgment motion differs from the ALJ’s role
in resolving a case after a hearing. The ALJ should not assess credibility or evaluate the
weight of conflicting evidence. Holy Cross Vill. at Notre Dame, Inc, DAB No. 2291, at 5
(2009).

C. Analysis

My findings and conclusions are in the italicized headings supported by the subsequent
discussion below.

1. CMS did not document that Petitioner failed to respond to the September
28, 2009 revalidation notice within 60 days of receipt.
2. CMS is not entitled to summary disposition on the record before me.

CMS argues that “[t]his case requires an application of the law to undisputed facts, and
the issues in this case turn on the legal interpretation of the regulations. .. These
regulations govern revocation of Medicare enrollment and billing privileges, and
interpretation of the regulations and application of those regulations to the undisputed
material facts are required to resolve this case. Accordingly, summary judgment is
appropriate in this matter.” CMS MSD at 5-6. The undisputed facts upon which CMS
relies are that TrailBlazer sent Petitioner notice by its September 28, 2009 letter that
Petitioner had to provide a completed CMS 855 application within 60 calendar days from
the date of that letter (CMS Ex. 1); Petitioner did not submit the required information in
that time; TrailBlazer again notified Petitioner by its December 18, 2009 revocation
warning (CMS Ex. 2) that Petitioner had to meet the revalidation requirements or face
revocation; and Petitioner did not timely respond to that notice. Petitioner argues that
both the September 28, 2009 revalidation letter and the December 18, 2009 revocation
warning were sent to a street address that CMS knew was not Petitioner’s mailing
address. HR.

Petitioner asserts, and CMS does not dispute, that as with several other volunteer
ambulance companies in the very rural area, they only have a street address “for 911
purposes” but cannot receive mail there because no mailbox exists at Petitioner’s physical
location. Letter from Petitioner to TrailBlazer, April 8, 2010. Petitioner claims that, as a
result, it did not receive any correspondence related to this matter until February 2, 2010
when the revocation notice was resent to Petitioner’s mailing address of P.O. Box
290184, Wethersfield, CT 06129. P. Response. Then, on February 17, 2010, Petitioner
received a notice indicating that Petitioner’s billing privileges had been revoked. Id.

As I have noted, CMS does not dispute that it had the information about the
“correspondence/pay-to” address and does not explain why that address was not used for
TrailBlazer’s mailings. Neither party has submitted a copy of Petitioner’s original
enrollment material in TrailBlazer’s files, but I note that a CMS-855 application provides
different sections for listing Petitioner’s practice location information, correspondence
address, and other contact information. The revalidation CMS-855 attached to
Petitioner’s hearing request shows the post office address as the correspondence address.
This application form states that this address “will be used by the fee-for-service
contractor if it needs to contact you directly.” The “65 Park Street” address is listed as
Petitioner’s practice location.

CMS argues that Petitioner was responsible for notifying TrailBlazer of any change in
location, but CMS does not allege that either Petitioner’s practice location address or
correspondence address has changed since Petitioner enrolled in the Medicare program.
See CMS Ex. 5, at (7. Moreover, CMS does not dispute that neither the September 28,
2009 notice letter nor the December 18, 2009 revocation notice were ever sent to
Petitioner at the post office address prior to late January of 2010. According to CMS, on
January 20, 2010 TrailBlazer received the December 18, 2009 revocation warning letter
back as undeliverable, which evidently triggered the decision to send the next notice to
the correspondence address, in Connecticut, on February 9, 2010. Id. at §J 8-9.

CMS does not provide any argument or explanation in response to Petitioner’s account of
the events. This silence leaves me without the benefit of CMS’s reasoning as to the legal
significance of Petitioner’s account. I cannot agree with CMS’s claim that it is
undisputed that Petitioner failed to respond to a revalidation request within 60 days of
receipt. Because that claim is central to CMS’s basis for summary judgment, I must deny
CMS’s motion

3. Dismissal without prejudice and remand is appropriate action based on
the record before me.

I turn next to determining what further process is appropriate to resolve this dispute. As
noted, TrailBlazer did not provide a reconsideration hearing to Petitioner because it
construed Petitioner’s request to be only to submit a CAP, which TrailBlazer rejected as
untimely because it was received more than 30 days (though less than 60 days) after the
revocation notice. I conclude for the reasons explained below that Petitioner’s April 9,
2010 request to TrailBlazer is best construed as seeking reconsideration. A
reconsideration process will allow CMS to develop the record concerning disputed facts
related to the mailing and receipt of the revalidation notice.

After speaking with TrailBlazer representatives, Petitioner submitted to TrailBlazer a
statement on a Part B CAP Request Form provided by TrailBlazer on April 9, 2010.
CMS Ex. 4. TrailBlazer treated this document as only a request for a CAP and rejected it
because the document was received past the 30 calendar days allotted to submit a request
ora CAP. A review of the actual statement made by Petitioner (set out above) suggests
that Petitioner was arguing that the revocation was in error, as well as seeking to show
present compliance by submitting the revalidation information. Thus, Petitioner states
that it is sending “this appeal” with a statement that the notices sent before February 2010
were not received because of TrailBlazer’s use of an incorrect address. These statements
are in the nature of assertions of past error by TrailBlazer rather of current compliance by
Petitioner.

The Board has explained how a CAP is distinct from the contractor reconsideration
process:

After the initial notice of revocation, the supplier has two tracks to seek to
avoid revocation and may elect to pursue either or both concurrently.
[Medicare Program Integrity Manual (MPIM)], Ch. 10, § 19.A. The
supplier, within 60 days, may request “reconsideration” of whether the
basis for revocation is erroneous or, within 30 days, it may submit a CAP to
demonstrate that it has corrected that basis. If the contractor accepts the
CAP, it notifies the supplier, and any reconsideration request is withdrawn.
If the contractor denies the CAP, the reconsideration process may proceed
to a hearing before a hearing officer, who reviews “the Medicare
contractor’s reason for imposing a. . . revocation at the time it issued the
action....” Jd. An unfavorable hearing officer decision is appealable to
an ALJ, who reviews the basis for the revocation. Jd. No provision is
made for an appeal of the contractor’s decision not to reinstate based on the
CAP. Id. The hearing officer conducting the reconsideration (and the ALJ
on appeal of the hearing officer decision) are limited to reviewing the basis
for revocation set out in the initial notice, not the merits of any contractor
decision that corrective action under a CAP was unacceptable.

DMS Imaging, Inc., DAB No. 2313, at 7-8 (2010) (footnote omitted).

In the event that a provider or supplier requests both a CAP and a reconsideration
simultaneously, the Medicare contractor is directed to “first process and make a
determination on the CAP.” MPIM Ch. 15, § 15.25. If the contractor does not accept the
CAP, a contractor Hearing Officer (HO) who was not involved in the initial
determination and CAP review is then to process the reconsideration and determine
whether the initial revocation was justified. /d. “In reviewing an initial enrollment
decision or a revocation, the HO should limit the scope of its review to the Medicare
contractor’s reason for imposing a denial or revocation at the time it issued the action and
whether the Medicare contractor made the correct decision (i.e., denial/revocation).” Jd.

On summary judgment, I must view the factual evidence in the light most favorable to the
non-movant, here Petitioner, and draw all reasonable inferences from the evidence in that
light. I cannot therefore assume the fact that a document is entitled “Part B CAP Request
Form” controls over the substance of the document itself. If the CMS contractor had
treated the CAP Request Form as a request for reconsideration, it appears the request
would have been timely received. In any event, CMS does not address whether, if
considered a request for reconsideration, such request was received within the required
60-day timeframe. Viewing the facts in the light most favorable to Petitioner, I conclude
that Petitioner intended to request reconsideration, which TrailBlazer, the CMS
contractor, failed to provide. Because Petitioner did not receive reconsideration at the
contractor level, this appeal is effectively premature.

Pursuant to 42 C.F.R. § 498.78(b), I may remand “at any time before notice of hearing
decision is mailed.” I therefore dismiss without prejudice and remand the matter to CMS
so that CMS or its contractor may review all relevant files and materials and take
appropriate action.
II. Conclusion

I therefore deny the CMS motion for summary disposition. I remand this case to CMS
for actions consistent with this decision and dismiss the appeal without prejudice to
Petitioner. 42 C.F.R. § 498.78(b). Thus, Petitioner may file a new request for hearing
before me if the decision on remand is unfavorable.

/s/
Leslie A. Sussan
Board Member