Department of Health and Human Services

DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Agape Rehabilitation of Rock Hill,
(CCN: 42-5159),

Petitioner

Vv.

Centers for Medicare and Medicaid Services.

Docket No. C-10-40

Decision No. CR2335

Date: March 9, 2011

DECISION

Petitioner, Agape Rehabilitation of Rock Hill (Petitioner or facility), is a long-term care
facility, located in Rock Hill, South Carolina, that participates in the Medicare program.
The parties agree that, from July 16 through August 23, 2009, the facility was not in

substantial compliance with Medicare

program requirements and that the Centers for

Medicare and Medicaid Services (CMS) may therefore impose penalties against it.

CMS also determined that the facility’

s practices in managing its residents’ anti-

coagulant medications were deficient and posed immediate jeopardy to resident health

and safety. It has imposed against the

‘acility civil money penalties (CMPs) of $5,200

per day for 20 days of immediate jeopardy and $250 per day for 19 days of substantial
noncompliance that was not immediate jeopardy. Petitioner challenges five of the
deficiencies cited, as well as the immediate jeopardy determination and the amount of the

CMPs.

For the reasons set forth below, I find that the facility was not in substantial compliance

with Medicare program requirements;

its deficiencies posed immediate jeopardy to

resident health and safety; and the penalties imposed are reasonable.
I. Background

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

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

Here, following a recertification survey completed July 31, 2009, CMS determined that
the facility was not in substantial compliance with multiple Medicare participation
requirements, specifically:

© 42C.F.R. § 483.10(c)(6) (Tag F160 — conveyance upon death) at a D level of
scope and severity (isolated instance of noncompliance that causes no actual harm
with the potential for more than minimal harm);

© 42 C.F.R. § 483.10(c)(7) (Tag F161 — assurance of financial security) at a D level
of scope and severity;

© 42C.F.R. § 483.13(a) (Tag F221 — physical restraints) at an E level of scope and
severity (pattern of noncompliance that causes no actual harm with the potential
for more than minimal harm);

© 42 CER. § 483.13(c)(1)(ii)-(iii), (c)(2)-(4) (Tag F225 — staff treatment of
residents) at a D level of scope and severity;

e 42 C.F.R. § 483.20(k)(3)(i) (Tag F281 — comprehensive care plans) at a J level of
scope and severity (isolated instance of noncompliance that poses immediate
jeopardy to resident health and safety);

e 42C.F.R. § 483.25 (Tag F309 — quality of care) at a K level of scope and severity
(pattern of noncompliance that poses immediate jeopardy to resident health and
safety);

e 42C.F.R. § 483.25(h) (Tag F323 — accidents and supervision) at a G level of
scope and severity (isolated instance of noncompliance that causes actual harm);
3

© 42 C.F.R. § 483.25(m)(2) (Tag F333 — medication errors) at an E level of scope
and severity;

e 42C.F.R. § 483.35(e) (Tag F367 — therapeutic diets) at a D level of scope and
severity;

e 42C.F.R. § 483.60(c) (Tag F428 — drug regimen review) at a D level of scope and
severity;

e 42 C.F.R. § 483.75(e)(5)-(7) (Tag F496 — nurse aide training) at a D level of scope
and severity;

© 42 C.F.R. § 483.75(j)(2)(i) (Tag F504 — laboratory services) at a D level of scope
and severity;

e 42 C.F.R. § 483.75(j)(2)(ii) (Tag F505 — laboratory services) at a J level of scope
and severity; and

e 42C.F.R. § 483.75(0)(1) (Tag F520 — quality assessment and assurance) at an E
level of scope and severity.

CMS also determined that three of these deficiencies (42 C.F.R. §§ 483.20(k)(3)(i),
483.25, and 483.75(j)(ii)) posed immediate jeopardy to resident health and safety. CMS
Exhibits (Exs.) 2, 3.'

CMS subsequently determined that the facility’s deficiencies no longer posed immediate
jeopardy as of August 5, 2009, and that the facility returned to substantial compliance on
August 24, 2009. CMS Exs. 5, 54.

CMS has imposed against the facility a CMP of $ 5,200 per day for 20 days of immediate
jeopardy (July 16 through August 4, 2009), and $250 per day for 19 days of substantial
noncompliance that was not immediate jeopardy (August 5 through 23, 2009), for a total
CMP of $ 108,750. CMS Exs. 3, 5, 54.

Petitioner timely requested a hearing to challenge five of the cited deficiencies: 42
C.F.R. § 483.13(c)(1)(ii)-(iii) (Tag F225 — staff treatment of residents); 42 C.F.R.

' In error, CMS asserted that it cited deficiencies under 42 C.F.R. §§ 483.15(e)(1) — Tag
F246 and 483.60(a) — Tag F425. CMS Closing Brief at 4. No such deficiencies were
cited, as CMS ultimately conceded. CMS Ex. 2; CMS Reply at 2. In its closing brief,
CMS also misstates the scope and severity for two of the deficiencies cited. Deficiencies
were cited at scope and severity level D (not E) for 42 C.F.R. §§ 483.60(c) and
483.75(j)(2)(i). CMS Ex. 2 at 42, 46.
4
§ 483.20(k)(3)(i) (Tag F 281 — comprehensive care plans); 42 C.F.R. § 483.25 (Tag F309
— quality of care); 42 C.F.R. § 483.25(h) (Tag F323 — accidents and supervision); and 42
C.F.R. § 483.75(j)(2)(ii) (Tag F505 — laboratory services). Petitioner also challenged
CMS’s determinations as to the scope and severity of the cited deficiencies, their
duration, and the remedies imposed. Hearing Request (October 13, 2009); CMS Ex. 56.

The parties agree that this matter may be decided based on the written record, without
need for an in-person hearing. See Order Following Prehearing Conference at 3 (May 28,
2010); P. Cl. Br. at 2; 42 C.F.R. § 498.66.

I admit into evidence CMS Exs. 1-62. I decline to admit CMS Exs. 63-65. My initial
order directed CMS to submit its proposed exhibits and other documents on or before
February 22, 2010. Acknowledgment and Initial Prehearing Order J] 1 (October 19,
2009). CMS complied and timely submitted CMS Exs. 1-62. By motion dated June 24,
2010, CMS asked to amend its exhibit list to add CMS Exs. 63, 64, and 65. CMS
Proposed Exhibits 63 and 64 are records relating to Residents 38 and 40. CMS Proposed
Exhibit 65 is a scholarly article from the American College of Chest Physicians, which
describes clinical practice guidelines relating to anticoagulation therapy.

On July 29, 2010, after the deadline for responding had passed, Petitioner objected to the
admission of these documents. By regulation, as well as my initial order, a party has 20
days in which to respond to a motion. 42 C.F.R. § 498.17(b); Acknowledgment and
Initial Prehearing Order § 22 (October 19, 2009). Petitioner has therefore waived its
objections. On the other hand, CMS provides no good cause for its failure to submit the
documents timely. See CMS Cl. Br. at 22 n.9 (claiming that the documents relating to
R38 and R40 were “inadvertently omitted”). I am not inclined to admit documents
submitted four months after their filing deadline without any legitimate justification
offered for the delay. I therefore decline to admit CMS Exs. 63-65. I also admit P. Exs.
1-35. See Order Following Prehearing Conference (May 28, 2010) at 2-3.”

> There have been additional complications with the exhibits. With its initial submission,
Petitioner omitted page 2 of P. Ex. 24. It subsequently submitted the page, and I include
it with the documents admitted. Portions of other exhibits (CMS Ex. 23 at 2; CMS Ex.
25 at 1,7; CMS Ex. 33 at 2; CMS Ex. 34; CMS Ex. 49; P. Ex. 30; and P. Ex. 31) were
difficult to read or had been cut off in copying. By motion dated July 29, 2010, Petitioner
asked to substitute a more legible copy of P. Ex. 31 at 1-13. Petitioner was unable to
obtain a legible copy of P. Ex. 30, a medication package insert, and asked to substitute an
alternative insert from a different manufacturer. I grant Petitioner’s motion to substitute.
With respect to CMS’s exhibits, CMS apparently obtained most of those documents
(except CMS Ex. 25 at 1, 7, where the cut-off portion seems minimal) from Petitioner
and could not provide better copies. Petitioner, however, had original copies of them and
submitted P. Exs. 34 and 35, copies of the problematic pages from CMS Exs. 34 and 33,
respectively, asking that they be admitted. In the absence of objections, I admit these
documents. CMS also submitted a more legible copy of CMS Ex. 49, which I substitute.

5
The parties have filed initial briefs (CMS Br.; P. Br.), closing briefs (CMS Cl. Br; P. Cl.
Br.), and replies (CMS Reply, P. Reply).
IL. Issues
Petitioner did not appeal nine of the deficiencies cited at scope and severity levels that
constitute substantial noncompliance, so the facility’s substantial noncompliance is not an
issue. The facility was not in substantial compliance with Medicare program
requirements.

The issues before me are:

1. Whether, from July 16 — August 23, 2009, the facility was in substantial
compliance with the following Medicare participation requirements:

42 C.F.R. § 483.13(c)(1)(1i)-(iii) and (c)(2)-(4)(staff treatment of residents);

42 C.F.R. § 483.20(k)(3)(i) (comprehensive care plans);

is

2 C.F.R. § 483.25 (quality of care);

42 C.F.R. § 483.25(h) (accident prevention); and

42 C.F.R. § 483.75(j)(2)(ii) (laboratory services).

2. If, from July 16 - August 4, 2009, the facility was not in substantial compliance

with 42 C.F.R. §§ 483.20(k)(3)(i), 483.25, 483.25(h), and 483.75(j)(2)(ii), did
those deficiencies pose immediate jeopardy to resident health and safety; and

3. Ifthe facility was not in substantial compliance, were the penalties imposed —
$5,200 per day for 20 days of immediate jeopardy, and $250 per day for 19 days
of substantial noncompliance that was not immediate jeopardy (total $108,750) —
reasonable?

Except for the finding of immediate jeopardy, I have no authority to review CMS’s scope
and severity findings. 42 C.F.R. § 498.3(b)(14); 42 C.F.R. § 498.3(d)(10).

Petitioner also raises some Constitutional claims, which I have no authority to review.
III. Discussion

A, The facility was not in substantial compliance with
Medicare requirements governing quality of care,
comprehensive care plans, and laboratory services — 42
C.F.R. §§ 483.25, 483.20(k)(3)(i), and 483.75(j)(2)(ii) —
because its procedures for immediately notifying the
attending physician (or nurse practitioner) of a resident’s
critical laboratory test results were not followed.*

Program requirements. Under the Act and “quality of care” regulation, each resident
must receive and the facility must provide necessary care and services to attain or
maintain the highest practicable physical, mental, and psychosocial well-being, in
accordance with the resident’s comprehensive assessment and plan of care. Act

§ 1819(b); 42 C.F.R. § 483.25. The regulation imposes on facilities an affirmative duty
designed to achieve favorable outcomes “to the highest practicable degree.” Windsor
Health Care Ctr., DAB No. 1902 at 16-17 (2003); Woodstock Care Ctr., DAB No. 1726
at 25-30 (2000).

The services provided or arranged by the facility must meet professional standards of
quality. 42 C.F.R. § 483.20(k)(3)(i).

With respect to laboratory services specifically, the facility must provide or obtain
laboratory services to meet the needs of its residents and is responsible for the quality and
timeliness of the services. 42 C.F.R. § 483.75(j)(1). The facility must promptly notify
the attending physician of laboratory findings. 42 C.F.R. § 483.75(j)(2)(ii).

Anticoagulant medications. In this case, CMS cited significant deficiencies involving the
facility’s practices with respect to anticoagulant drugs, particularly Coumadin (Warfarin).

Anticoagulant drugs help to inhibit the formation of blood clots and are often prescribed
to individuals who have experienced inappropriate blood clotting, such as those who have
had heart attacks, strokes, or deep vein thrombosis. CMS Exs. 38, 39; P. Ex. 30.
Unfortunately, bleeding is a major complication associated with anticoagulants. P. Ex.
33 at 6. For individuals administered these drugs, blood levels must be monitored
carefully to assure that they are within a safe and therapeutic range. CMS Ex. 39 at 2. If
the levels are too high, the resident risks bleeding complications; if the levels are too low,
stroke could result. See CMS Ex. 32 at 13; CMS Ex. 39, at 1; P. Ex. 13 at 16 (Jones
Decl. § 3). The need for careful monitoring is even more pronounced when the resident
is prescribed additional medications, because Coumadin interacts with many other drugs
in dangerous, even fatal, ways. P. Ex. 13 at 14 (Jones Decl.); P. Ex. 30 at 5-6.

* My findings of fact/conclusions of law are set forth, in italics and bold, in the discussion
captions of this decision.
7
A specific test, referred to as PT/INR (prothrombin time/international normalized ratio)
evaluates the ability of blood to clot properly. P. Ex. 30 at 4. The INR is the ratio of an
individual’s prothrombin time to a control (i.e., normal) sample — the higher the INR, the
greater the chance of bleeding. A very low INR suggests the risk of a blood clot. Normal
ranges for a healthy person are 0.9 to 1.3; for people on Coumadin, desirable ranges may
be 2.0 to 3.0. CMS Ex. 39 at 4. However, many factors — such as patient age, diet,
manner of administration — can affect the test results, so the physician generally
determines an acceptable range for each individual patient, based on the individual’s
PT/INR. CMS Ex. 39 at 2; P. Ex. 13 at 14; P. Ex. 30 at 7. See CMS Ex. 39 at 2
(reiterating that “[i]t cannot be emphasized too strongly that treatment of each patient is a
highly individualized matter”). According to the manufacturer, an INR above 4.0
exposes the patient to a higher risk of bleeding without providing any additional
therapeutic benefit. CMS Ex. 39 at 4. Ina black box warning, the manufacturer cautions
that Coumadin can cause major or fatal bleeding, which is more likely to occur during the
starting period of the medication. Risk factors for bleeding include an INR greater than
4, and the patient’s age (65 or older). CMS Ex. 39 at 1.

In treating deep vein thrombosis, physicians commonly prescribe subcutaneous Lovenox
(Enoxaparin) in addition to Coumadin, until the patient’s blood levels reach a therapeutic
level. So, when the patient’s INR reaches 2.0 to 3.0, the Lovenox is discontinued. P. Ex.
31 at 3; CMS Ex. 38 at 7.

Facility policies and procedures. Here, the facility contracted with Meridian Laboratory
to provide the bulk of its laboratory services. P. Ex. 8. Under the terms of their written
agreement, Meridian was to send a phlebotomist to the facility on Tuesdays and
Thursdays to perform routine blood draws. P. Ex. 8 at 5. Meridian agreed to inform the
facility of critical lab values by telephone upon completion of the test. P. Ex. 8 at 4; P.
Ex. 2 at 3 (Henderson Decl. § 21); CMS Ex. 35. Meridian also agreed to provide routine
lab results within 24 hours. P. Ex. 8 at 4.

According to the facility’s administrator, Danielle Henderson, non-critical lab results
were “typically faxed” to the office of the facility’s nurse manager at some time in the
afternoon. P. Ex. 2 at 3 (Henderson Decl. § 19, 22); CMS Ex. 35.

The facility required its staff to notify immediately the facility’s nurse practitioner or the
resident’s attending physician of any critical lab result. P. Ex. 9 (Brown Decl. 45); CMS
Ex. 35. According to Elizabeth Ann Brown, the facility’s nurse practitioner, when
informed of a critical lab result, she would “immediately” pull the resident’s record,
review the result, review the records, visit the resident, and change medication orders as
necessary. P. Ex. 9 (Brown Decl. § 6).

The facility’s standing orders for Coumadin required staff to decrease dosages (by 0.5
milligrams (mg.) for one week) when INR values were between 3.1 and 4.5, and to
contact the physician when INR values exceeded 4.5. If INR values fell below 1.5, staff
8
were to increase the dosage by | mg.; for values from 1.5 to 2.0, they were to increase the
dose by 0.5 mg. CMS Ex. 32 at 15; CMS Ex. 40.

CMS does not fault any of these procedures for ensuring the safety of facility residents
receiving anticoagulants. See P. Ex. 13. However, in July 2009, those procedures were
not followed, and staff continued to administer full doses of anticoagulant medications to
a resident whose test results registered a dangerously high INR.

Resident 41 (R41). R41 was an 87-year-old woman admitted to the facility on July 14,
2009, “for short term rehab” after surgery (open reduction and internal fixation) to repair
a right hip fracture. She had a history of breast cancer, depression, and vitamin B12
deficiency. CMS Ex. 19 at 9. She was also diagnosed with deep vein thrombosis. CMS
Ex. 19 at 9-10. Among other medications, she was prescribed two anticoagulants,
Coumadin (5 mg daily by mouth at 6:00 p.m.) and Lovenox (60 mg, subcutaneously,
twice daily at 9:00 a.m. and 9:00 p.m.). CMS Ex. 19 at 20.

Her physician also ordered PT/INR testing to commence on July 16, 2009 (a Thursday)
and weekly thereafter, on Tuesdays. CMS Ex. 19 at 20.

On July 16, R41’s INR measured a critically-high 9.96. CMS Ex. 19 at 3. According to
Meridian’s report, the lab completed the testing at 1:32 p.m. that day and called the
results in to “Susan Rice” at 1:33 p.m. The document also shows that the report was
faxed to the facility on July 16 at 10:18 p.m. CMS Ex. 19 at 3.

No one named “Susan Rice” worked at the facility. However, Licensed Practical Nurse
(LPN) Susan Brice was assigned to care for R41. CMS Ex. 19 at 15, 31, 35, 37. CMS
argues that Meridian called the lab results in to her. Petitioner denies receiving any such
call, pointing to records of the incoming calls received by the facility between 1:18 p.m.
and 1:38 p.m. on July 16. P. Ex. 34; CMS Ex. 34.

CMS, on the other hand, points to the lab report itself, which indicates that laboratory
staff made the call and identifies by name (with only a minor and understandable error) a
specific facility employee to whom the message was given. CMS Ex. 19 at 3. Surveyor
notes indicate that a lab supervisor assured the surveyors that a lab employee made the
call, pointing out that lab employees would not know the names of facility staff but are
required to document the name of the person taking the call. CMS Ex. 19 at 41. How
would lab staff have known the name of R41’s nurse if they had not made the call? Even
the error in the name seems to support CMS’s position, since this is the type of error
commonly made when an unfamiliar name is given over the telephone.

Moreover, in her declaration, LPN Brice does not address specifically whether Meridian
called her with the critical lab results on July 16. Instead, she explains her responses to
surveyor questions about the lab results. According to LPN Brice, she initially told the
surveyor that she remembered receiving a call on July 21, but “could not recall the lab on
9
July 16.” But she also inconsistently admits that she told the surveyor that she notified
the nurse practitioner of the lab results on the 16" and the 21“. P. Ex. 28 (Brice Decl.
9 5, 7); see CMS Ex. 19 at 5. She did not document on either day receiving a call from
the lab or notifying the physician /nurse practitioner of the lab results, so the absence of

such a note among the July 16 nurses’ notes has no particular significance. CMS Ex. 19
at 32.

By themselves, CMS’s arguments are compelling, but whether these arguments are
sufficient to overcome the facility’s telephone records is certainly debatable. In any
event, I need not resolve the question, because federal regulations hold the facility as
responsible for the actions of its contractors as it is for the actions of its employees. 42
C.F.R. § 483.20(k)(3)(i) (requiring that services arranged by the facility meet
professional standards of quality); 42 C.F.R. § 483.75(j)(1) (making the facility
responsible for the quality and timeliness of its laboratory services).

R41’s physician should unquestionably have been informed of the critical lab results no
later than the afternoon of July 16. The parties agree that no one conveyed the results to
either the nurse practitioner or to R41’s attending physician until some time the following
day.” In the meantime, staff administered a full dose of Coumadin at 6:00 p.m. on July
16. They administered Lovenox to R41 at 9:00 p.m. on July 16, and 9:00 a.m. on July
17. CMS Ex. 19 at 24.

It appears that the physician first learned of the critical test results on July 17, although
the record does not indicate when and by whom the information was conveyed.
According to Nurse Practitioner Brown, she was not notified of R41’s July 16 lab results
until “some time on July 17.” P. Ex. 9 (Brown Decl. J 7). Other than saying she
received a copy of the faxed critical lab results “at some time” on July 17, Nurse
Practitioner Brown is vague as to exactly when and how she learned of the results and
what actions she took, claiming generally that she took her usual steps. Administrator
Henderson notes that the lab report was faxed to a locked office on Thursday night, so no
one would have picked it up until the following day, but she does not say when it was

4 | find a disturbing absence of documentation in the facility’s records. The record
includes virtually no evidence that staff documented any consultations with physicians
about significant lab results.

* Although not cited by CMS, regulations also require staff to consult immediately a
resident’s physician when there is 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); or 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). 42 C.F.R. § 483.10(b)(11). No
one disputes that R41’s critical test results evidenced a need to alter treatment
significantly.
10
picked up. Nor does she indicate how the physician or nurse practitioner learned of
R41’s critical INR level. P. Ex. 2 at 4 (Henderson Decl. § 23).

1 infer that someone eventually advised the physician, because physician telephone orders
dated July 17 instruct staff to hold the Coumadin for three days and “resume [at] 4.5,”
discontinue the Lovenox, and repeat the PT/INR on Tuesday, July 21. CMS Ex. 19 at 17.
The orders do not indicate what time they were given.

On July 21, 2009, the lab test was repeated, and R41’s INR measured at an even-higher
level — greater than 10 (+10). CMS Ex. 19 at 4. Meridian’s documents indicate that the
lab called the results in to “Susan Rice” at 10:52 a.m., and the document shows that it
was faxed to the facility. CMS Ex. 19 at 4, 11.

A physician’s telephone order, taken at 1:00 p.m. on July 21, says to hold the Coumadin
until further notice, administer Mephyton (Vitamin K) “now,” and to repeat the PT/INR
test on July 23, 2009. CMS Ex. 19 at 17,38. Nursing notes for that day refer to the
instruction to hold the Coumadin. CMS Ex. 19 at 38. A second telephone order, also
dated July 21, says to discontinue Vitamin K, which probably explains why the
medication was not given. CMS Ex. 19 at 18.°

On July 23, a different laboratory, Piedmont Medical Center Laboratory, tested R41’s
blood. Her INR was still >10. CMS Ex. 19 at 12. Physician’s telephone orders dated
July 23, July 24, July 26, and July 27 instruct staff to hold the Coumadin and repeat the
PT/INR. CMS Ex. 19 at 18-19. By July 28, R41’s INR was down to 6.34, which is still
abnormally high. CMS Ex. 19 at 13.

Based on these facts, I find that the facility was not in substantial compliance with 42
C.F.R. §§ 483.25, 483.20(k)(3)(i), and 483.75(j)(2)(ii). Staff did not follow the facility’s
own protocol, which created the potential for more than minimal harm.

Although he minimizes the potential harm posed by a one-day delay in adjusting
Coumadin dosages, the facility’s medical director, James Lee Jewell, M.D., does not
extend that opinion to situations involving critical INR levels. He begins his opinion
with the exception, opining that a short delay would cause no harm “if the PT/INR is not
at a critical level” and in the absence of abnormal bleeding. P. Ex. 24 (Jewell Decl. § 9).
Crystal F. Todd, the facility’s pharmacist agrees: “So /ong as a resident’s PT/INR is not

° In its closing brief, CMS complains, for the first time, that Mephyton was not
administered to R41, even though, at 1:00 p.m., the physician ordered it given “now.”
CMS Cl. Br. at 13. The surveyors cited no deficiency in this regard, and I agree with
Petitioner that a closing brief is simply too late to raise this new allegation. In any event,
although I am troubled by the facility’s insufficient documentation as to exactly what
happened with these orders, I would not fault staff for failing to follow an order that had
been rescinded.
11
at a critical level, a dosage difference of .5 or 1 mg. of Coumadin would not cause the
potential for more than minimal harm.” P. Ex. 5 at 2 (Todd Decl. § 9) (emphasis added).

Another of Petitioner’s witnesses, Kelly W. Jones., Pharm.D., notes that Coumadin is a
very complicated medication, so facilities should have in place a standard protocol for
managing its residents who are administered the drug.

It is very important to realize that a systematic approach to
monitoring INR’s for [Coumadin] is important and in my
opinion saves lives rather than placing residents at undue risk.

P. Ex. 13 at 15 (Jones Decl. § 1). The facility had such an approach in place. As
described above, it required the lab to inform facility staff of any critical lab values “upon
completion of the test,” and required facility staff to notify immediately a resident’s
attending physician of that result. Thus, if the facility’s procedures were followed, a
resident’s attending physician would know about critical test results almost immediately.
Standing orders also required nursing staff to decrease Coumadin dosages when INR
values fell between 3.land 4.5, and to contact the physician when levels exceeded 4.5.
CMS Ex. 32 at 15; CMS Ex. 40.

I may reasonably rely on these policies as evidence of the facility’s “own judgment as to
what must be done to attain or maintain it residents’ highest practicable physical, mental
and psychosocial well-being, as required by section 483.25.” Senior Rehab and Skilled
Nursing Ctr., DAB No. 2300 (2010), aff'd, Senior Rehab and Skilled Nursing Ctr. v.
HHS, No. 10-60241 (2011) (quoting Sheridan Health Care Ctr., DAB No. 2178 at 15
(2008)).

But on July 16 the facility policies were not followed, and, as a result, staff administered
three additional doses of anticoagulant medications to a resident who already had a
critically high INR, placing the resident at undue risk for hemorrhage or other serious
bleeding. See CMS Ex. 38 at 12; CMS Ex. 39 at 1. The facility therefore failed to
provide R41 the care and services she needed to attain her highest practicable physical
well-being and was not in substantial compliance with 42 C.F.R. § 483.25. Nor did the
facility promptly notify the attending physician of the laboratory findings, as required by
42 C.F.R. § 483.75(j)(2)(ii). Because the standard of care (as reflected in the facility’s
own policies) calls for prompt physician notification, these services did not meet
professional standards of quality, as required by 42 C.F.R. § 483.20(k)(3)(i).

The facility presented testimony from a nurse consultant, Karon Goldsmith, who opines
that Meridian was at fault for any delay in notification, because Meridian did not timely
report the test results to the facility. P. Ex. 14 at 8 (Goldsmith Decl.). But, as noted
above, it does not help the facility to blame laboratory staff, because services provided or
arranged by the facility must meet professional standards of quality, and, by regulation,
12
the facility is responsible for the quality and timeliness of its laboratory services. 42
CER. §§ 483.20(k)(3)(i), 483.75()(1).”

Moreover, when facility staff picked up the fax on July 17, they knew, or should have
known, that either: 1) the lab timely notified LPN Brice of the critical test results, and
she failed to notify the attending physician/nurse practitioner; or 2) laboratory staff failed
to notify the facility of the lab results and falsified a document to indicate that they had
done so. Either of these options demonstrates a significant break-down in the facility’s
procedures for reporting critical lab results. But, until after the survey, it does not appear
that anyone at the facility was particularly concerned about the problem; no one
questioned LPN Brice, contacted Meridian or made any other effort to determine what
went wrong. Such inaction suggests a lack of concern about whether facility procedures
were followed.

Dr. Jones’s testimony reflects a similar lack of concern. After extolling the virtues of the
facility’s policies and procedures, he summarily dismisses, as insignificant, the facility’s
failure to follow them in this case. According to Dr. Jones, “even the best of systems and
their application can fail us” because “[e]ven well constructed systems . . . are subject to
human error.” P. Ex. 13 at 15 (Jones Decl. § 1). The Departmental Appeals Board
(Board) has long recognized that virtually all deficiencies are, at bottom, attributable to
human error and that the regulations include no “human error” exception. Barn Hill Care
Ctr., DAB No. 1848 at 18 (2002).

Moreover, to accept Dr. Jones’s opinion, I would have to agree that, under the standard of
care, a facility may, from time to time, wait more than 19 hours before informing a
resident’s attending physician of her critical PT/INR test results and may also, without
consulting the physician, continue to administer powerful anticoagulant drugs to a
resident at high-risk for bleeding based on her age (over 65) and INR values

(significantly greater than 4). I do not agree. | find that the facility’s failure to follow its
own procedures for immediately notifying the attending physician (or nurse practitioner)
of R41’s critical lab results put it out of substantial compliance with Medicare program
requirements.

7 Moreover, had facility staff been able to recover the faxed report on the night of July

16, R41 could have avoided at least one dose of the Lovenox. The facility itself is plainly
responsible for the location of its fax machine and for having instructed the lab to fax its
test results to a machine that was accessible to nursing staff only when the nurse manager
was there. As the following discussion shows, the facility’s reliance on one specific
nurse to recover the faxed lab reports seriously impaired its ability to consult timely
attending physicians about necessary treatment changes.
13
B. The facility was not in substantial compliance with 42
C.F.R. § 483.25, because it repeatedly disregarded standing
orders to adjust dosages of Coumadin, delayed advising
physicians of significant lab test results, and delayed
implementing physicians’ orders to change the dosages of
the anticoagulant medication.

CMS points to multiple instances in which facility staff: 1) disregarded standing orders
to adjust dosages of Coumadin; 2) delayed informing the attending physician of a
significant lab test result; and/or 3) did not timely respond to a physician’s order to
change the dosage of anticoagulant medications. Petitioner apparently does not dispute
that the delays occurred, but argues that “any cited delay in carrying out orders or the
very limited instances of a lack of documentation in the administration of anticoagulant
therapy does not place residents at risk for serious injury or harm.” P. Cl. Br. at 19
(emphasis added).

I discuss below CMS’s immediate jeopardy determination. Here, in determining whether
these findings constitute substantial noncompliance, however, I apply a different standard
— whether the facility practice posed the potential for “more than minimal” (not
“serious”) harm. 42 C.F.R. § 488.301.

Resident 19 (R19). R19 was a 92-year-old woman admitted to the facility on April 13,
2009. CMS Ex. 15 at 1. She had a history of pulmonary embolism and diagnoses of
deep vein thrombosis, chronic obstructive pulmonary disease, dementia, anemia, and
osteoporosis. CMS Ex. 15 at 1. Prior to May 12, she was receiving 2.0 mg. of Coumadin
daily; however, according to lab results reported at 1:35 p.m. that day, her PT/INR
measured 22.4/1.95. CMS Ex. 15 at 12. Based on the facility’s standing orders, staff
should have increased her Coumadin dosage by 0.5 mg. CMS Ex. 40. An undated hand-
written notation on the lab report, which appears to have been signed by her physician,
calls for a 0.5 mg. increase.* The record includes no other written order, nor does it
indicate when this order was given. CMS Ex. 15 at 12. Staff did not increase R19’s
Coumadin on May 12, but began administering the increased dose (2.5 mg.) at 6:00 p.m.
on May 13. CMS Ex. 15 at 32.

Staff continued administering that dosage until May 21, when it was increased to 3.0 mg.
CMS Ex. 15 at 32. At 12:56 p.m. on May 26, 2009, Meridian reported that R19’s
PT/INR was 16/1.42. CMS Ex. 15 at 10. Based on the standing order, staff should have
increased her Coumadin by 1.0 mg. CMS Ex. 40. They again disregarded the order and
continued to administer 3.0 mg. The record does not indicate when or how the physician
was notified of the lab result, but an undated handwritten note on the lab report,
apparently signed by the physician, says to increase the dosage by 1 mg. CMS Ex. 15 at
10. A telephone order written at 8:00 a.m. on May 27 calls for Coumadin 4.0 mg. daily.
CMS Ex. 15 at 22. Staff still failed to increase the Coumadin, administering 3.0 mg. at

* See, e.g., P. Ex. 16 at 22 for a sample of the physician’s written signature.
14
6:00 p.m. on May 27. Almost twenty-four hours later, at 5:00 p.m. on May 28, staff
finally followed both the standing order and the telephone order. CMS Ex. 15 at 32.
This delay is especially puzzling since staff wrote on the face of the Medication
Administration Record (MAR) that the 3.0 mg. Coumadin order was discontinued on
May 27. Id.

On June 9, 2009, R19’s blood was drawn at 9:50 a.m. and test results “approved” at

11:38 a.m. Her PT/INR was 45/3.78. CMS Ex. 15 at 15. Once more, staff did not
follow the standing order, which directed them to decrease the Coumadin dosage by 0.5
mg. Nothing in the record indicates when or how the physician learned of the test results,
but a telephone order dated June 10 at 8:00 a.m. notes the test results and orders the
Coumadin decreased to 3.5 mg. CMS Ex. 15 at 19. Staff decreased the Coumadin at
6:00 p.m. on June 11, more than two days after the test results were known (and when the
standing order should have been implemented) and more than one day after the physician
specifically ordered the change. CMS Ex. 15 at 31.

On June 23, R19’s test results were 16.2/1.44, which Meridian reported to the facility at
1:03 p.m. An undated, unsigned, hand-written notation on the report says “current 3.5
mg.[;] increase by 1.0 mg.[;] new dose 4.5 mg.” In the corner of the document, it appears
that the physician initialed to indicate that he had reviewed the report. Again the initials
are not dated. CMS Ex. 15 at 23. Again, according to the facility’s standing order, staff
should have increased the Coumadin dosage by 1 mg. CMS Ex. 40. But at 6:00 p.m. on
June 23, staff administered 3.5 mg. of Coumadin to the resident. CMS Ex. 15 at 31. Ina
telephone order received at 12:20 p.m. the following day, R19’s physician increased the
dosage to 4.5 mg. (CMS Ex. 15 at 17), and that evening, June 24, staff administered the
correct dosage. CMS Ex. 15 at 26.

On July 7, 2009, R19’s PT/INR was 69.2/5.69. CMS Ex. 15 at 14. Ina progress note
also dated July 7, Nurse Practitioner Brown notes the elevated INR and writes “will hold
Coumadin and resume at reduced dose — repeat INR [in] 7 days. Follow closely.” P. Ex.
16 at 19.° She does not indicate how long the hold should be, but a telephone order dated
July 7 directs staff to “hold Coumadin” for twenty-four hours. CMS Ex. 15 at 16. Yet,
contrary to this order, the MAR directs staff to hold the Coumadin for two days, and
shows that staff did not administer the drug on either July 7 or 8. CMS Ex. 15 at 24.
They administered the medication on July 9 and 10, but, without explanation,
administered no Coumadin on either July 11 or July 12, resuming it on July 13. CMS Ex.
15 at 24. A doctor’s progress note, dated July 9, says “meds reviewed” but does not
indicate any changes in the order for Coumadin. P. Ex. 16 at 22.

° Curiously, a doctor’s progress note is also dated July 7, but it does not mention the
resident’s INR or any orders for Coumadin. P. Ex. 16 at 23.
15
Ina progress note dated July 13, 2009, Nurse Practitioner Brown says that R19 is
“bleeding from the side of her mouth.” P. Ex. 16 at 16.'° Upon examination, she notes
“old dried blood from lips” but “no evidence bleeding from mouth or tongue.” P. Ex. 16
at 16. She does not mention Coumadin. Ina July 15 follow-up, Nurse Practitioner
Brown notes R19’s PT/INR as 22/1.92 on July 14. She directs staff to decrease
Coumadin from 4 mg. to 3.5 mg. and to recheck in a week, which is puzzling because the
physician’s standing order says to increase the dose by 0.5 mg. when the INR value is
between 1.5 and 2.0. P. Ex. 16 at 11; CMS Ex. 40.'!

The test was repeated on July 21, 2009, and R19’s PT/INR results were 82.4/6.72, which
the lab characterized as “critical.” According to the lab report, the laboratory staff called
those results in to “Susan Rice” at 10:52 a.m. and reported again to the facility at 12:02
p.m. (presumably by fax). CMS Ex. 15 at 5. A hand-written notation on the report says
“hold [for] 2 days[,] then 4 mg.” The physician initialed the report, and his initials are
dated July 22. CMS Ex. 15 at 5. In her July 21 progress note, Nurse Practitioner Brown
notes the test results and directs staff to hold the Coumadin for two days, then resume at a
reduced dose. She says to repeat the INR on July 28, and to watch for bleeding. P. Ex.
16 at 13. But, without explanation, staff held the medication for three days — July 21,
July 22, and July 23. CMS Ex. 15 at 24.'? Nurses’ notes for these days do not mention
the lab tests or Coumadin. P. Ex. 16 at 4.

Resident 20 (R20). R20 was an 88-year-old man admitted to the facility on May 13,
2009, for rehabilitation following hip surgery. CMS Ex. 16 at 1; P. Ex. 17 at 33. He had
a long list of diagnoses, including coronary artery disease with a history of myocardial

® The progress reports from Nurse Practitioner Brown are very confusing because of the
manner in which Petitioner submitted them. Not only has Petitioner submitted them in
no particular order, but in some instances, page 2 does not immediately follow page one
of the report. I have sorted them out as follows : July 7 progress report — P. Ex. 16 at 18-
19 (with a duplicate at 20-21); July 13 progress report — P. Ex. 16 at 16-17; July 15
progress report — P. Ex. 16 at 8, 11; July 16 progress report — P. Ex. 16 at 14-15; July 21
progress report — P. Ex. 16 at 12-13; July 24 progress report — P. Ex. 16 at 10, 9.

" There may have been valid reasons for this deviation from the standing order, but
nothing in the record suggests that anyone even referred to that order, much less
explained why it should not be followed in this instance.

? The MAR suggests that staff confused the directions to hold the medication. Under the
order for “Coumadin 4.5 mg.,” they indicate “hold” for two days — July 21 and 22. But
under the subsequent order “Coumadin 4 mg.,” they repeat “hold [for] two days,” and
count July 22 and 23 as the two days for which they held that order. The physician had
ordered them to hold the Coumadin for two days total (July 21 and 22), then resume at
the lower dose (4.0 mg.) on July 23.
16
infarction, atrial fibrillation, and diabetes. He had suffered a post-operative bleed. CMS
Ex. 16 at 1; P. Ex. 17 at 33. At the time of his admission, he was prescribed 5 mg. of
Coumadin daily. CMS Ex. 16 at 3. According to the surveyor notes (which Petitioner
does not challenge), on May 19, 2009, his PT/INR results were 41.7/3.52, and those
results were apparently available at 4:11 p.m. CMS Ex. 16 at 3. Staff did not follow the
facility’s standing order to decrease the Coumadin dosage by 0.5 mg. for two days but
continued to administer the full 5.0 mg. Ina written order, dated May 20, R20’s
physician directed staff to decrease the dosage by 0.5 mg., to 4.5 mg. Staff did not lower
R20’s Coumadin dose until the next day, May 21, two days after the facility received the
abnormal test results. CMS Ex. 16 at 3.

On May 26, at 10:38 a.m., R20’s PT/INR measured 21.6/1.89. Staff did not follow the
standing order but gave R20 4.5 mg. of Coumadin that day. On May 27, R20’s physician
ordered a 0.5 mg. increase in Coumadin, but, again, staff did not follow that order until
the following day, May 28. CMS Ex. 16 at 3.

A progress note written by Nurse Practitioner Paula Smith on June 1, 2009, indicates that
the resident was then suffering from cellulitis of a wound on his left foot, as well as
painful muscle spasms in his thighs. She also reported that he had fallen three days
earlier and suffered a skin tear on his right forearm. She did not mention his Coumadin.
P. Ex. 17 at 33-35.

On June 2, 2009, at 12:21 p.m., R20’s PT/INR tests results were 19/1.67. Again, no one
paid any attention to the standing order. A day later, his physician increased his
Coumadin dosage by 0.5 mg., but the facility did not implement that order until June 4.
CMS Ex. 16 at 3.

Resident 1 (R1). R1 was an 87-year-old woman admitted to the facility on May 11,
2009. She had a long list of diagnoses, including cerebral artery occlusion, atrial
fibrillation, aortic valve disorder, and history of a cerebral vascular accident. She had a
long list of prescribed medications, including Coumadin. CMS Ex. 10 at 1,2. On May
12, 2009, Meridian reported PT/INR results of 17.4/1.54. CMS Ex. 10 at 6. Consistent
with the facility’s standing order, at 4:00 p.m. that day, her physician ordered her
Coumadin increased from 2.5 mg. to 3.0 mg. CMS Ex. 10 at 7. Yet, staff did not comply
with that order until 6:00 p.m. on May 13. CMS Ex. 10 at 12.

Mid-day on May 26, Meridian reported PT/INR levels of 23/1.99.'* CMS Ex. 10 at 10.
Again, according to the facility’s standing orders for Coumadin, staff were supposed to
increase the dose (then at 2.5 mg.) by 0.5 mg. CMS Ex. 40. They disregarded the
standing order and administered 2.5 mg. at 6:00 p.m. that day. CMS Ex. 10 at 12. An
undated hand-written note on the face of Meridian’s report, apparently initialed by R1’s
physician, says to increase the dosage by 0.5 mg. CMS Ex. 10 at 10. Ina telephone

© Citing the report, CMS says that Meridian reported these results at 1:35 p.m., but the
report sets the time at 12:56 p.m. CMS Ex. 10 at 10.
17
order, written at 8:00 a.m. on May 27, R1’s physician discontinued Coumadin at 2.5 mg.
and ordered Coumadin at 3.0 mg. daily. CMS Ex. 10, at 11. At 6:00 p.m. on May 27,
staff increased the dosage to 3.0. CMS Ex. 10 at 12.

On June 9, at 12:02 p.m., Meridian reported PT/INR results of 39.9/3.37. CMS Ex. 10 at
15. An undated, unsigned hand-written note says “on 3.5 mg.[,] decrease to 3.0[,] repeat
in | week.” CMS Ex. 10 at 15. According to the facility’s standing order, staff were to
decrease the dosage by 0.5 mg. CMS Ex. 40. But R1’s MAR shows that staff
administered 3.5 mg. on June 9 and on June 10. CMS Ex. 10 at 21. Ina telephone order,
written at 8:00 a.m. on June 10, R1’s physician discontinued Coumadin at 3.5 mg. and
ordered Coumadin at 3.0 mg. CMS Ex. 10 at 16. Staff finally decreased her dosage on
June 11. CMS Ex. 10 at 21. So staff once more disregarded the standing order and
delayed implementing the physician’s telephone order.

On June 16, R1’s PT/INR measured 21.9/1.91. CMS Ex. 10 at 17. An undated, unsigned
handwritten note says “on 3 mg. [change] to 3.5 mg.,” which would have been consistent
with the standing order. CMS Ex. 10 at 17; CMS Ex. 40. The facility received a
telephone order at 3:31 p.m. on June 16 to change the 3 mg. dosage to 3.5 mg. CMS Ex.
10 at 18. Nevertheless, at 6:00 p.m. that day, staff administered 3.0 mg. They increased
the dosage the following day, June 17. CMS Ex. 10 at 21.

On June 23, 2009, R1’s PT/INR values were 15.1/1.34. CMS Ex. 10 at 19. Another
undated note on the lab report says to increase by 1.0 (again consistent with the standing
order). An undated signature indicates that the physician reviewed the lab report at some
point. On June 23, a physician’s telephone order directs staff to increase the dosage by
1.0 mg., from 3.5 mg. to 4.5 mg. daily. CMS Ex. 10 at 20. Yet, staff administered 3.5
mg. Coumadin on June 23, and began the new dosage on June 24. CMS Ex. 10 at 21, 24.

Resident 39 (R39). R39 was a 96-year-old woman admitted to the facility in 2005,
whose diagnoses included dementia, atrial fibrillation, congestive heart failure, and
angioneurotic edema. CMS Ex. 18 at 1; P. Ex. 22 at 7-10. On May 26, 2009, Meridian
reported her PT/INR results as 41.4/3.5. CMS Ex. 18 at 18. On the face of the report, an
undated hand-written note, initialed by the physician, says “on 6 [decrease] by 0.5.”
CMS Ex. 18 at 18. An 8:00 a.m. telephone order, dated May 27, instructs staff to
decrease the Coumadin to 5.5 mg. CMS Ex. 18 at 19. But on May 26 and 27, staff gave
R39 6.0 mg. of Coumadin. They did not decrease the dosage until May 28. CMS Ex. 18
at 20.

On June 3, Meridian reported PT/INR test results of 16.5/1.46. On the face of Meridian’s
report is another hand-written note, initialed by the physician, which says “on 5.5

[; increase] by 5.5.” CMS Ex. 18 at 14. This is an obvious error. Under no
circumstances could the physician have intended a 5.5 mg. increase in Coumadin. Also
perplexing is a physician’s telephone order form dated June 3 at 8:00 a.m. that includes
the same test results (16.5/1.46) and instructs staff to increase Coumadin from 5.5 to 6.5
mg. daily. CMS Ex. 18 at 15. This must be another error, since the test referred to in the
18
order was not performed until the afternoon of June 3. In any event, under the standing
order, staff should have increased the dosage by 1 mg. CMS Ex. 40. The MAR shows
that staff discontinued the 5.5 mg. dosage on June 3, but did not administer the 6.5 mg.
losage until June 4, failing to give her any Coumadin on June 3. CMS Ex. 18 at 16-17.

On June 9, Meridian reported PT/INR levels of 15.2/1.35. CMS Ex. 18 at 9. Staff did
not follow the standing order to increase the dosage. At 8:00 a.m. on June 10, R39’s
physician ordered a | mg. increase in the Coumadin dosage, from 6.5 mg. to 7.5 mg.
laily. CMS Ex. 18 at 10. But once more, staff failed to increase the dosage until June

di. CMS Ex. 18 at 11.

On July 14, Meridian reported PT/INR levels as 70.2/5.77, a critical level. According to
the report, Meridian called the facility and reported the result to Estrella Cohn. An
undated, hand-written note on the face of the report says “on 8.5 mg. hold x 2 days then
start Coumadin 8.0 mg.” CMS Ex. 18 at 4. A physician’s telephone order dated July 14
repeats that staff should hold Coumadin for two days, then start at 8 mg. per day. CMS
Ex. 18 at 5. According to a July 15 progress note written by Nurse Practitioner Brown,
R39’s Coumadin would be held for two days and then decreased from 8.5 mg. to 8.0. mg.
daily. P. Ex. 22 at 6. But the resident’s MAR shows that staff held the Coumadin for
three days, July 13, 14, and 15. CMS Ex. 18 at 6. Why they held it on July 13 is a
mystery, since the facility had not yet learned of the critical test results.

Resident 42 (R42). Finally, CMS cites two instances in which staff delayed making
ordered changes to R42’s Coumadin dosages. R42 was an 81-year-old woman with
multiple diagnoses, including congestive heart failure, coronary artery disease, deep vein
thrombosis, diabetes, atrial fibrillation and hypertension. She had undergone a coronary
artery bypass graft. CMS Ex. 20 at 1; P. Ex. 23 at 35, 38-40. On June 2, 2009, Meridian
reported her PT/INR values at 18.1/1.59. An undated handwritten note on the face of the
report says “on 1 mg. [increase] 0.5 mg.” and the attending physician’s undated initials
indicate that he reviewed the document. CMS Ex. 20 at 4. According to the facility’s
standing order, the dose should have been increased by 0.5 mg. CMS Ex. 40. A June 3,
8:00 a.m. telephone order increases the dosage to 1.5 mg. daily. CMS Ex. 20 at 5. Staff
did not make the change until June 4. CMS Ex. 20 at 6.

On June 16, R42’s PT/INR values were 21.5/1.88, which, according to the standing
order, called for a 0.5 increase in dosage. Another undated handwritten note, initialed by
the physician, indicates that her dosage should be increased from 2 mg. to 2.5 mg. CMS
Ex. 20 at 8; CMS Ex. 40. A June 16, 3:32 p.m. telephone order includes the same
instructions. CMS Ex. 20 at 9. Yet, staff did not increase R42’s Coumadin dosage until
the following day, June 17. In fact, the MAR indicates that, rather than increasing the
dosage on June 16, as ordered, staff gave her no Coumadin at all that day. CMS Ex. 20 at
10.

No one seriously questions that, under the standard of care, changes in Coumadin
dosages should be implemented as soon as the new lab values are known, and that
19
medication orders (including standing orders) should be implemented on the day they are
received or per the physician’s instructions. CMS Ex. 10 at 32; CMS Ex. 26 at 1; P. Ex.
24 (Jewell Decl. ¥ 9) (stating “‘it is ideal if the dosage is changed on the day the PT/INR is
drawn’). Staff should not delay implementing valid orders. Yet, with alarming
regularity, facility staff disregarded entirely the facility’s standing orders and responded
to abnormal lab values only after they received the attending physician’s telephone order.
Staff then regularly delayed implementing that order. As a result, up to two days could
elapse before they adjusted a resident’s Coumadin dosage.

Dr. Jones suggests that the facility’s practice in this regard was part of a deliberate and
consistent policy in which “{a]ll residents get labs drawn on one day and interpretation
and action on the next day.” Dr. Jones opines that such a system is preferable to “an
inconsistent or haphazard method of lab draws, interpretations, and recommendations,”
which “puts the patients at greater risk of harm.” P. Ex. 13 at 16 (Jones Decl. § 4).
Whether any long term care facility may, as a matter of policy, deliberately delay
administration of its physician orders (standing or individualized) to achieve consistency
is highly questionable.'* But here, no evidence supports Dr. Jones’ assumption that these
delays reflected the institution’s protocol for managing anti-coagulant therapy. To the
contrary, the evidence establishes that the facility had no consistent and effective
procedure in place. Sometimes staff adjusted a resident’s medication on the day of the
testing; sometimes they adjusted it a day later; and sometimes they adjusted it two days
later. The facility has offered no consistent or satisfactory explanation for the delays, a
failure that suggests precisely the situation Dr. Jones characterizes as putting residents “at
greater risk of harm.”

According to CMS, the LPN assigned to pick up the faxed lab reports offered a partial
explanation for the delays. She told the surveyors that they occurred because she was at
times not at the facility when the lab faxes arrived. She was the only one who picked up
the reports, so no one would get the information unless and until she returned to work.
CMS Ex. 15 at 34. Petitioner does not challenge this assertion, which does not explain
all of the delays (e.g., delays following receipt of the physician’s order), but is consistent
with Administrator Henderson’s testimony that reports faxed to the nurse manager’s
locked office would not be picked up until the nurse reported for duty. P. Ex. 2 at 4
(Henderson Decl. § 23).

In their declarations, Administrator Henderson and Director of Nursing (DON) Natasha
Wells opine that delays in changing dosages of medication may have been “due to the
timing of obtaining the new dosage from the pharmacy.” P. Ex. 2 at 5 (Henderson Decl.

“ Dr. Jones also claims that such systemic delays are “very common in many private
practice settings” including his own. P. Ex. 13 at 16 (Jones Decl. § 4). But his is a
“family medicine” practice, which presumably involves a population that is significantly
less vulnerable than the aged and infirm residents of a nursing home. P. Ex. 13 at 14.
20
4 30); P. Ex. 3 at 3 (Wells Decl. § 17).'° Even if true, that explanation hardly helps the
facility. Given the number of residents dependent on Coumadin, the facility should have
in place a reliable method for obtaining promptly the ordered dosages. Moreover, a
problem obtaining the drug does not explain the instances in which staff administered too
much Coumadin. See CMS Ex. 19 at 16, 24; CMS Ex. 15 at 19, 31; CMS Ex. 16 at 3;
CMS Ex. 10 at 15, 16, 21; CMS Ex. 18 at 18, 20.

The above discussion shows that the facility did not have in place an effective system to
assure the facility’s prompt response to abnormal PT/INR values. Equally disturbing,
and unexplained, were the numbers of instances in which staff incorrectly implemented
the physician’s order — they held the medication for two days instead of one (CMS Ex. 15
at 24); they twice held the medication for three days instead of two (CMS Ex. 15 at 24;
CMS Ex. 18 at 6); and they twice failed to administer any medications when they should
have increased the resident’s dosage (CMS Ex. 18 at 16-17; CMS Ex. 20 at 10).

These failures meant that staff often administered the wrong dosage of anticoagulant
medications. A facility is not providing the care necessary to assure a resident’s highest
practicable well-being if it administers drugs in dosages that are different from the one
currently ordered by the resident’s attending physician. On this basis, the facility was not
in substantial compliance with the quality of care regulation, 42 C.F.R. § 483.25.'°

C. The facility was not in substantial compliance with 42
C.F.R. § 483.25(h), because staff did not take reasonable
steps to prevent foreseeable accidents; they did not
consistently follow care plan instructions for preventing
accidents and did not adjust interventions that proved
ineffective. ”

Program requirements. So that a resident can attain or maintain the highest practicable
physical, mental, and psychosocial well-being, in accordance with his/her comprehensive

'’ One of the nurses, however, told the surveyors that “[i]f the dosage is adjusted [and] it
is late in the day, Coumadin is available in the E-Boxes. | of each unit.” CMS Ex. 26 at
1.

'© Because I find that the deficiencies relating to the facility’s administration of anti-
coagulant drugs more than justifies CMS’s findings of substantial noncompliance and
immediate jeopardy under 42 C.F.R. § 483.25, as well as the penalties imposed, I need
not address the adequacy of its hospice services to Residents 9, 12, and 14. See
Claiborne-Hughes Health Ctr., No. 09-3239 at 11 (6th Cir. 2010); Carrington Place of
Muscatine, DAB No. 2321 at 20-21 (2010).

" Again, I do not address whether the facility’s failure to protect R4 from accidents also
constituted neglect, putting the facility out of substantial compliance with 42 C.F.R.

§ 483.13(c), because the deficiency findings I have sustained, as well as the un-appealed
deficiencies, more than justify the penalties imposed.
21
assessment and plan of care, the “quality of care” regulation mandates that the facility
“ensure” that each resident’s environment remains as free of accident hazards as possible.
42 C.F.R. § 483.25(h)(1). It must “take reasonable steps to ensure that a resident receives
supervision and assistance devices designed to meet his assessed needs and to mitigate
foreseeable risks of harm from accidents.” Guardian Health Care Ctr., DAB No. 1943 at
17 (2004) (citing 42 C.F.R. § 483.25(h)(2)); Briarwood Nursing Ctr., DAB No. 2115 at 5
(2007). The facility must anticipate what accidents might befall a resident and take steps
to prevent them. A facility is permitted the flexibility to choose the methods it uses to
prevent accidents, but the chosen methods must constitute an “adequate” level of
supervision under all the circumstances. Briarwood, DAB No. 2115 at 5; Windsor
Health Care Ctr., DAB No. 1902, at 5 (2003); see Burton Health Care Ctr., DAB No.
2051 at 9 (2006) (holding that determining whether supervision/assistive devices are
adequate for a particular resident “depends on the resident’s ability to protect himself
from harm’’).

Resident 4 (R4). The deficiencies cited under 42 C.F.R. § 483.25(h) center around R4.
R4 was a 92-year-old man, admitted to the facility on January 29, 2009, with diagnoses
of stroke, osteoarthritis, dementia, depression, and remote subdural hematomas. CMS
Ex. 11 at 1. He had a history ofa left hip fracture caused by a fall. CMS Ex. 11 at 25.
Notwithstanding that history, a series of fall risk assessments, dated January 29 through
February 19, indicate that he did not then present a high risk for falls. CMS Ex. 11 at 50.

Nevertheless, his care plan described him as at high risk for falls because of his
diminished cognition and poor safety awareness. CMS Ex. 11 at 15. The plan set as a
goal that he would “exhibit no [signs or symptoms] of injury related to falls without
intervention through (an unspecified) review date.” Under the “approaches” column,
staff are told to: 1) keep his call light within reach, encourage him to use it, and respond
promptly to his requests for assistance; 2) “anticipate and meet needs”; 3) coordinate with
appropriate staff to ensure a safe environment with floors free from spills and clutter, call
light in place, bed in low position at night, side rails as ordered, handrails on walls, and
personal items within reach; 4) physical therapy to evaluate and treat as ordered; 5)
“evaluate for” and supply adaptive equipment or devices “as needed,” and reevaluate “as
needed for continued appropriateness and to ensure least restrictive device or restraint”;
6) provide activities that minimize the potential for falls; and 7) ensure that he is wearing
appropriate footwear when ambulating or up in his wheelchair. CMS Ex. 4 at 15.

At the time of his admission, staff completed a restraint assessment for a wheelchair
seatbelt, which his physician apparently ordered at that time. He also had orders for a
low bed with tumble mat. CMS Ex. 11 at 3, 9, 12-13, 25, 52.

On February 9, 2009, R4 was “found on the floor” lying on his left side. His bed rails
were up. To prevent recurrence, the report indicates that a bed alarm will be applied to
22
the resident while in bed and that staff would keep the bed rails up. CMS Ex. 11 at 38. '®
The record contains no evidence that a bed alarm was ordered or installed until months
(and numerous falls) later.

An incident/accident report, dated February 19, 2009, indicates that, notwithstanding the
February 9 instructions to “keep the bed rails up,” no bed rails were ordered and none
were used. According to the report’s narrative, R4 “slid down from sit to stand” and “let
go of hand rails.” He was taken by ambulance to the hospital. To prevent recurrence, the
report instructs staff to “monitor resident while using sit to stand” and calls for additional
training for the nurse aides involved in the incident. CMS Ex. 11 at 39.

Another incident/accident report says that on April 28, 2009, a nurse aide was passing
R4’s room when she noted him sitting on the floor of his bathroom in front of the
commode. His wheelchair was outside the bathroom door. To prevent recurrence, the
report says that staff would keep the resident in viewing sight when not accompanied by
staff or family, and would make sure that his safety belt is secure. CMS Ex. 11 at 45. A
note describing the incident was added to his care plan, with the approach that staff
“ensure safety belt secure.” CMS Ex. 11 at 70.

A note dated April 29, 2009, which may refer to the April 28 incident, says that he “was
found” on his bathroom floor by a nurse aide who happened to be passing by his room.
The nurse aide assigned to care for him admitted that she had not securely applied the
resident’s safety belt. She also noted that the resident is able to remove the safety belt
whenever the belt was loose. He had taken himself to the bathroom and attempted to get
on the commode without assistance. CMS Ex. 11 at 16.

By April 29, R4’s assessments indicated that he was at high risk for falls. An undated
addendum to the assessments says that he is in the facility’s “falling star” program, has a
low bed with mat, wheelchair seatbelt, and rear “‘anti-tippers” to his wheelchair, and a
bed alarm. CMS Ex. 11 at 51. Inasmuch as his physician did not order a bed alarm until
May 13, I assume the addendum post-dates May 13. On April 29, however, R4’s care
plan was apparently amended to address the “potential for complications related to use of
physical restraint,” his wheelchair safety belt. The plan directs staff to follow the facility
protocol for assessing restraint use and release. Staff are also instructed to “offer
opportunities for restraint-free time and physical activity daily.” CMS Ex. 11 at 69.

'* Side rails are potentially dangerous restraints, and their usefulness should be carefully
assessed. See, e.g., Laurelwood Care Ctr., DAB 2229 at 9 (2009). Isee neither an
assessment nor a physician’s order for side rails in R4’s record. Staff appears to have
used them inconsistently. Compare CMS Ex. 11 at 38 with CMS Ex. 11 at 39, 40. CMS,
however, has not pursued the issue with respect to the facility’s use of side rails. But see
CMS Ex. 2 at 38; CMS Br. at 14 (noting CMS expresses concern about the facility’s
restraint assessment for R4’s seat belt).
23
On May 12, 2009, R4 was found on the floor of his room with a cut to his forehead,
bleeding profusely. He was sent to the emergency room for stitches. Again, the steps to
prevent recurrence are “seat belt needs to be put ona little tighter,” and to apply anti-
tippers to the rear of the wheelchair to prevent the criss-cross seat belt from releasing.
CMS Ex. 11 at 46, 65. A note added to his care plan on that day said “remind staff to
place safety belt on [wheelchair at] all times, including meals and activities.” It also
notes that a bed alarm is to be added on May 13, and calls for rear “‘anti-tippers” to the
wheelchair to prevent the criss-cross seat belt from becoming undone. CMS Ex. 11 at 70.

His order sheet indicates that an order for a bed alarm was finally added on May 13.
CMS Ex. 11 at 9.

On May 20, 2009, a housekeeper passing R4’s room noticed that his wheelchair was
tipped forward, and his legs were underneath the chair. His seatbelt was in place. Notes
to prevent recurrence say: medication evaluation and have the resident at activity, if
possible, or at the nurses’ desk or in the TV area when not in bed. It also mentions anti-
tippers. CMS Ex. 11 at 47, 61, 63. The following day a nurse noted that his forehead
was bruised above the right eyebrow, which she attributed to the recent fall. CMS Ex. 11
at 61. According to his care plan, a medical evaluation was done for agitation. CMS Ex.
11 at 70.

On June 15, 2009, R4 tipped over his wheelchair while in the dining room. According to
the incident report, the nurse aide, who was a new employee, had released the seatbelt,
apparently in the presence of other staff. CMS Ex. 11 at 22; P. Ex. 6 (Fitzpatrick Decl.
44); P. Ex. 7 (Blackman Decl. § 4); P. Ex. 3 at 2 (Wells Decl. § 10). The nurse aide’s
superiors then counseled her that the “resident’s restraint not to be released” and
instructed her “to ask other coworkers and check [patient care plan] for seatbelt orders.”
CMS Ex. 11 at 22-23, 70, 73.”

An incident report dated June 30, 2009, says that the resident got out of bed while having
breakfast. He fell on the floor and hit the right side of his forehead and suffered a skin
tear to his right arm. According to this report, bed rails were ordered and in place at the
time of the accident. To prevent recurrence, the report says that R4 needs to be out of
bed in his wheelchair with the safety belt attached during all meals. CMS Ex. 11 at 42,
56, 70.

On July 11, 2009, the nurse “was called to” R4’s room. He was lying on the floor with
his wheelchair behind him. According to the report, the lap belt was not hooked to the
back of the wheelchair, although a nurse’s note inconsistently says that the lap belt “was
hooked on” the wheelchair. According to the report, the “current interventions” included
wheelchair seatbelt at all times, bed alarm, rear and forward anti-tippers, and a medical

In telling the nurse aide that the restraint was “not to be released,” facility staff
apparently did not consider that the physician order also (appropriately) called for
“release per protocol for repositioning.” CMS Ex. 11 at 9.
24
evaluation. To prevent recurrence, the report says to steer him to common areas when he
is up in his wheelchair and to apply dycem (a non-slip material) to the wheelchair to
reduce sliding back and forth. CMS Ex. 11 at 41, 58, 71.

On July 14, 2009, the resident’s bed alarm sounded, alerting Nurse Aide T. Roberts that
the resident was on the floor beside a floor mattress. The report indicates that bed rails
were ordered and were up. To prevent recurrence, staff were to keep the bed alarm in
place, have a low bed and floor mattress in place, and to monitor the resident frequently.
CMS Ex. 11 at 40, 59.

According to CMS, notwithstanding the multiple instances in which R4’s seat belt was
improperly applied, facility management declined to investigate or retrain the nurse aides,
explaining to the surveyors that the nurse aides had already been trained in restraints
during their orientation to the facility. CMS Ex. 11 at 3. Petitioner has repeated that
claim here. According to DON Wells, “[u]pon new employee orientation, all [nurse
aides] are trained in the appropriate use of restraints and, as part of that training, the
[nurse aide] is subject to competency checks.” P. Ex. 3 at 2 (Wells Decl. 99). She also
claims, remarkably, that “[b]ecause no problems had been identified at the [flacility
concerning the proper use of restraints, no additional inservice was needed.” P. Ex. 3 at 3
(Wells Decl. § 13).

I find this position remarkable, inasmuch as the facility’s own records document R4’s
repeated falls and some injuries as a result of staff’s failures to secure his seat belt. In
one instance, he fell because a nurse aide deliberately released the belt, in contravention
of his care plan instructions. These incidents should have alerted the facility that its
employees were not adequately supervising him.

Even though Petitioner repeatedly attributed R4’s falls to its staff’s failure to secure his
seat belt adequately, it argues here that it should not be held accountable for those failings
because the resident himself made the task so difficult. According to Administrator
Henderson, he “continuously leaned side to side and far forward, stretching the restraint
nearly to its limits, thereby loosening it to the point that it came out of position. ...” P.
Cl. Br. at 33; P. Ex. 2 at 2 (Henderson Decl. § 8). But this argument only strengthens
CMS’s case. The facility recognized that R4 was capable of thwarting their plan, yet it
neither identified that behavior as a problem nor addressed it in the resident’s plan of
care. Instead, the facility continued reminding staff to tighten the belt, even though staff
plainly did not or could not comply in a way that would keep the resident safe.

Moreover, not all of R4’s falls were caused by an improperly attached seat belt. He also
fell from his bed. To meet his assessed need and mitigate the risk of harm from
accidents, the facility staff called for a bed alarm following his February 9 fall. Yet the
alarm was not ordered or in place until May 13, more than three months later. After his
April 28 fall, staff were instructed to “have [him] in viewing sight.” CMS Ex. 11 at 45. I
see no evidence of any systematic effort to assure that level of supervision. In fact, as
subsequent falls show, he was not supervised as required.

25

Thus, the facility did not take reasonable steps to provide the level of supervision and the
assistive devices that R4 needed to meet his assessed needs and to mitigate foreseeable
risks of harm from accidents. The facility was therefore not in substantial compliance
with 42 C.F.R. § 483.25(h).

D. CMS’s determination that the facility’s deficiencies
posed immediate jeopardy to resident health and safety is
not clearly erroneous.

Immediate jeopardy exists if a facility’s noncompliance has caused or is likely to cause
“serious injury, harm, impairment, or death to a resident.” 42 C.F.R. § 488.301. CMS’s
determination as to the level of a facility’s noncompliance (which would include an
immediate jeopardy finding) must be upheld unless it is “clearly erroneous.” 42 C.F.R.

§ 498.60(c). The Board has observed repeatedly that the “clearly erroneous” standard
imposes on facilities a “heavy burden” to show no immediate jeopardy, and has sustained
determinations of immediate jeopardy where CMS presented evidence “from which
‘[o]ne could reasonably conclude’ that immediate jeopardy exists.” Florence Park Care
Ctr., DAB No. 1931 at 27-28 (2004) (citing Koester Pavilion, DAB No. 1750 (2000));
Daughters of Miriam Ctr., DAB No. 2067 at 7, 9 (2007).

Here, everyone agrees that Coumadin is a complicated medication and that the
consequences of its mismanagement can be dire. P. Ex. 13 at 14-15 (Jones Decl. § 1).
The manufacturer’s black box warning underscores that Coumadin can cause major or
fatal bleeding, which is more likely to occur in the elderly, and in those with an INR
greater than4. CMS Ex. 39 at 1. In this case, R41’s INR value was more than double
that black box value. Yet, staff failed to consult her physician and continued to
administer to her anticoagulant medications, thus increasing her risk.

Petitioner minimizes the risk by pointing out that she was not actively bleeding at the
time. While fortuitous, the immediate jeopardy standard does not require actual harm,
and, given her blood level, R41 was just a fall or bruise away from a true medical
emergency. This alone satisfies the standard for immediate jeopardy.

While Dr. Jones minimized the risk posed by continuing to administer higher doses of
Coumadin to residents with high INRs (defined as greater than 5), he also claimed that an
INR of less than 2 presents a real danger to someone in need of anticoagulant therapy. P.
Ex. 13 at 16 (Jones Decl. § 3a.) (“You are ten times more likely to have a stroke (which is
what we are trying to prevent with [Coumadin]) with an INR less than 2 versus the
patient having a bleed from a high INR of >5.”).° The record contains multiple instances

* In reaching his conclusion, Dr. Jones relied on a treatise on anticoagulant therapy in
patients with mechanical heart valves. He did not demonstrate that conclusions drawn
from a study of that population would apply to these nursing home residents.
26
in which staff delayed increasing the dosages to residents with INR values below 2. At
least twice the staff not only delayed increasing the dosages, they neglected to administer
any of the ordered Coumadin. CMS Ex. 18 at 14, 16-17; CMS Ex. 20 at 8, 10.

The facility’s over-arching problem was that staff ignored the physician’s standing
orders, routinely delayed notifying the physician of abnormal test results, and then
delayed implementing the physician’s orders to change dosages. The facility simply did
not have in place a reliable system for timely adjusting dosages of Coumadin based on
lab values or for timely implementing physician orders. I am not aware of any
responsible authority that permits a facility such delays. The facility’s systemic failure to
follow physician orders at the time they were given created a potentially dangerous
situation for all of its residents in need of anticoagulant medications.

CMS’s immediate jeopardy determination is therefore not clearly erroneous.
E. The penalties imposed are reasonable.

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

In reaching a decision on the reasonableness of the CMP, I consider whether the evidence
supports a finding that the amount of the CMP is at a level reasonably related to an effort
to produce corrective action by a facility with the kind of deficiencies found, and in light
of the above factors. I am neither bound to defer to CMS’s factual assertions, nor free to
make a wholly independent choice of remedies without regard for CMS’s discretion.
Barn Hill Care Ctr., DAB No. 1848, at 21 (2002); Cmty. Nursing Home, DAB No. 1807,
at 22 et seq. (2002); Emerald Oaks, DAB No. 1800, at 9-10 (2001); CarePlex of Silver
Spring, DAB No. 1683, at 8 (1999).

CMS has imposed penalties of $5,200 per day, which is at the low-to-mid penalty range
for situations of immediate jeopardy ($3,050-$10,000), and $250, which is at the low end
of the penalty range for per-day CMPs ($50-$3,000). 42 C.F.R. §§ 488.408(d),
488.438(a)(1).

Nevertheless, there seems no dispute that, for an individual in need of anticoagulant
therapy, an INR below 2 puts him/her at serious risk.
27
The facility had a history of substantial noncompliance. During its prior annual surveys,
deficiencies were cited under tags F309 (quality of care) and F323 (accidents and
supervision). CMS Ex. 6.

Petitioner has not argued that its financial condition affects its ability to pay the penalty.

With respect to the remaining factors, I consider all of the facility’s deficiencies,
including those that Petitioner does not contest. The sheer number of deficiencies cited
(14), as well as their scope and severity (one at level K, two at level J, one at level G, and
three at level E) justifies penalties well above the minimum.

Here, the facility simply did not have in place systems that would protect an especially
vulnerable population. I find the facility is particularly culpable because it not only failed
to act promptly in response to R41’s critical lab values, but then, knowing that its
procedures for reporting lab values had failed, it took no action to correct.

I also consider the facility culpable because it did not protect R4. Knowing that he was
vulnerable, and that his behaviors increased his risk of serious injury, facility staff failed
to address the problem, demonstrating disregard for his safety.

Based on all of the significant deficiencies cited, I do not find the penalties imposed
unreasonable.

IV. Conclusion

For the reasons discussed above, I find that the facility was not in substantial compliance
with the Medicare requirements, its deficiencies posed immediate jeopardy to resident
health and safety, and I affirm as reasonable the penalties imposed.

/s/
Carolyn Cozad Hughes
Administrative Law Judge


Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD

Civil Remedies Division

Kimberlee Mixon,
Petitioner
Vv.
Centers for Medicare and Medicaid Services.
Docket No. C-10-968
Decision No. CR2334

Date: March 4, 2011

DECISION DISMISSING APPEAL FOR CAUSE

For the reasons set forth below, I dismiss this case pursuant to 42 C.F.R. § 498.70. I find
that Petitioner, Kimberlee Mixon, failed to file a timely reconsideration request or
establish good cause to extend the time for such filing. Therefore, the Medicare
contractor properly denied Petitioner’s request for reconsideration. Without the previous
administrative review, Petitioner does not have a right to an Administrative Law Judge
(ALJ) hearing to review the merits of Petitioner’s appeal of the Centers for Medicare and
Medicaid Services’ (CMS’s) determination to revoke Petitioner’s Medicare billing
privileges.

I. Background

On November 7, 2008, the Oklahoma Board of Medical Licensure and Supervision
ordered that Petitioner’s physician assistant license number PA1288 be revoked
following Petitioner’s third DUI offense, a felony. CMS Ex. 2. The Oklahoma Board of
Medical Licensure and Supervision is authorized to enforce the Oklahoma Allopathic
Medical and Surgical Licensure and Supervision Act as necessary to protect the public
health safety and welfare. Id. at 4. The Oklahoma Board of Medical Licensure and
2

Supervision concluded that Petitioner was “guilty of unprofessional conduct in that she . .
. [i]s unable to practice medicine with reasonable skill and safety to patients by reason of
... drunkenness, excessive use of drugs, narcotics, chemicals or any other type of
material or as a result of any mental or physical condition ....” Jd. Petitioner did not
report the revocation of her medical license to CMS or the Medicare Administrative
Contractor, Trailblazer Health Enterprises, LLC (“Trailblazer”) following the Final Order
of Revocation dated November 7, 2008.

Trailblazer notified Petitioner, by letter dated May 7, 2009, that her Medicare billing
privileges were revoked retroactive to November 6, 2008. CMS Ex. 1, at 6-7. The letter
advised Petitioner that her billing privileges were revoked based upon records obtained
from the Oklahoma Board of Medical Licensure and Supervision that revealed a sanction
had been imposed against Petitioner showing her noncompliance with the enrollment
requirements set forth at 42 C.F.R. § 424.535(a)(3). Id. at 6.

On July 15, 2010, Petitioner requested reconsideration of the initial determination
decision dated May 7, 2009. CMS Ex. 1, at 2-3. Petitioner alleged that she never
received this initial determination because it was addressed to her former employer,
McAlester Regional Hospital. /d. Petitioner therefore claimed she was not properly
notified that she was barred from reenrolling in the Medicare program and also claimed
that the revocation and reenrollment bar should be rescinded. Jd. Petitioner’s request for
reconsideration did not address her failure to inform CMS or Trailblazer of a change in
her current address of record. On July 30, 2010, Trailblazer notified Petitioner that it
received her request for reconsideration past the time limit and therefore did not issue a
decision. Jd. at 1.

By letter dated September 7, 2010, Petitioner filed an appeal and request for hearing
before an ALJ regarding CMS’s determination to revoke Petitioner’s Medicare billing
privileges. This case was initially assigned to Board Member Leslie A. Sussan pursuant
to 42 C.F.R. § 498.44, which permits a Board Member to hear appeals under 42 C.F.R.
part 498. An Acknowledgment and Pre-hearing Order was sent to the parties on
September 20, 2010.

On October 25, 2010, this case was reassigned to me for hearing and decision. On
October 20, 2010, CMS filed for summary judgment. With its brief (CMS Br.), CMS
submitted six exhibits (CMS Exs. 1-6). On November 17, 2010, Petitioner filed an
exchange of evidence and argument and counter-motion for summary judgment (P. Br.).
With its brief, Petitioner submitted three exhibits (P. Exs. 1-3). In the absence of
objection, I admit CMS Exs. 1-6 and P. Exs. 1-3 to the record.
II. Applicable Law and Regulations

The regulations at 42 C.F.R. Part 424, subpart P, set out the requirements for enrollment
and reporting of changes to enrollment information. “Providers and suppliers must meet
and maintain these enrollment requirements to bill either the Medicare program or its
beneficiaries for Medicare covered services or supplies.” 42 C.F.R. § 424.500.

CMS may revoke the Medicare billing privileges of an enrolled provider or supplier for
any of the reasons listed in 42 C.F.R. § 424.535. Medicare billing privileges of an
enrolled provider or supplier may be revoked for noncompliance with the enrollment
requirements. 42 C.F.R. § 424.535(a). In addition, CMS may revoke the Medicare
billing privileges of an enrolled provider or supplier for failure to report to Medicare
within ninety days any changes to the information furnished on the enrollment
application. 42 C.F.R. § 424.520(b)(2008).!

Also, Subsection 424.535(a)(9) authorizes CMS to revoke billing privileges where a
provider or supplier failed to comply with the reporting requirements including the
requirement that “‘[p]hysicians [and] nonphysician practitioners . . . must report . . . to
their Medicare contractor. . . [aJny adverse legal action.” 42 C.F.R. § 424.516(d)(1)(ii).
A “[f]inal adverse action” is defined to include “[s]uspension or revocation of a license to
provide health care by any State licensing authority.” 42 C.F.R. § 424.502.

A provider or supplier dissatisfied with an initial determination related to the denial or
revocation of Medicare billing privileges may request reconsideration. 42 C.F.R.

§ 498.5(k)(1). Any provider or supplier dissatisfied with a reconsidered determination
under 42 C.F.R. § 498.5(k)(1) is entitled to a hearing before an ALJ. 42 C.F.R.

§ 498.5(k)(2). In accordance with 42 C.F.R. § 498.22(b)(3), Petitioner must file the
request for reconsideration “within 60 days from receipt of the notice of initial
determination . . .” and, pursuant to 42 C.F.R. § 498.22(d), if Petitioner is unable to file
the request within the 60 days specified, it may file a written request with CMS stating
the reasons why the request was not filed timely and CMS will extend the time for filing
a request for reconsideration if Petitioner shows good cause for missing the deadline.

'42 C.F.R. § 424.520(b) was in effect on November 6, 2008 and is the applicable
regulation requiring Petitioner to report a change of information within ninety days.
Effective January 1, 2009 42 C.F.R. § 424.516(d)(1) requires reporting of a change in
ownership, an adverse legal actions, or a change in address within thirty days and “all
other changes in enrollment must be reported within 90 days.” 42 CFR § 424.516(d).
4
Ill. Findings of Fact, Conclusions of Law, and Supporting Discussion

My findings of fact and conclusions of law are set out as separate headings followed by
supporting discussion.

A. Petitioner is not entitled to a hearing before an ALJ

Petitioner does not have a right to an ALJ hearing to review this matter. A Medicare
hearing officer did not issue a reconsideration decision regarding CMS’s initial
determination to revoke Petitioner’s Medicare billing privileges. Thus, I lack jurisdiction
to consider whether CMS properly revoked Petitioner’s Medicare billing privileges or
whether Petitioner was in compliance with the applicable Medicare enrollment
requirements. 42 C.F.R. § 498.5(k)(2).

B. Petitioner’s request for reconsideration is untimely and Petitioner has
not demonstrated good cause to extend the time for filing

I conclude that the denial of Petitioner’s request for reconsideration was correct. The
number of days between the date of the initial determination regarding the revocation of
Petitioner’s Medicare billing privileges (May 7, 2009) and the date of the request for
reconsideration (July 15, 2010) is 434 days. The reconsideration request was required to
be filed within 60 days under the authorities cited above. Thus, CMS correctly denied
Petitioner’s request for reconsideration as it was untimely.

Ifa Petitioner shows good cause for missing the deadline, CMS will extend the time for
filing a request for reconsideration. 42 C.F.R. § 498.22(d)(2). Petitioner essentially
claims that CMS failed to provide her with notice that her Medicare billing privileges
were revoked because CMS mailed the May 7, 2009 letter to her former employer,
McAlester Regional Hospital. P. Br. at 4. However, Petitioner ignores relevant
regulations which provide that a provider or supplier must report to CMS any changes to
the information furnished on an enrollment application and furnish supporting
documentation within ninety calendar days of the change. 42 C.F.R. § 424.520(b)
(2008).? Thus, Petitioner had a duty to report any changes to her enrollment application
previously filed with CMS, including the revocation of her physician assistant license and
changes to Petitioner’s address, but she did not do so.

The relevant requirements are imposed by statute and duly promulgated regulations, of
which participating suppliers are presumed to have notice and a Medicare supplier has a

> As previously noted, effective January 1, 2009, the regulation changed and required
providers to report certain events, such as changes in ownership, adverse legal actions,
and changes in practice location, to a Medicare contractor within 30 days. 42 C.F.R. §
424.516(d)(1).
5

duty to understand and comply with all the applicable regulations and familiarize itself
with the legal requirements of the Medicare program. See, e.g., Waterfront Terrace, Inc.,
DAB No. 2320, at 7 (2010) (holding provider of Medicare services should be expected to
possess at least a rudimentary understanding of program rules and terminology), citing
Heckler v. Cmty. Health Servs. of Crawford County, 467 U.S. 51, 63, 64 (1984) (noting
participant in the Medicare program had “duty to familiarize itself with the legal
requirements” for cost reimbursement); Thomas M. Horras and Christine Richards, DAB
No. 2015, at 34 (2006) (finding officer and principal of provider had responsibility to be
aware of and adhere to applicable law and regulations), aff’d Horras v. Leavitt, 495 F.3d
894 (8th Cir. 2007).

Thus, it is clear to me that the fact that CMS sent the notice letter to Petitioner’s last
address of record, but that it did not subsequently attempt to locate the Petitioner, is not
an adequate basis for a good cause determination. Petitioner has failed to establish that
good cause exists to extend the time for filing based on her own failure to report her
change in address.

IV. Conclusion

Petitioner does not have a right to an ALJ hearing to review her revocation of Medicare
billing privileges as she did not timely file a request for reconsideration, and I do not find
good cause to justify extending the time for filing. I therefore dismiss this case for cause.
42 CFR. § 498.70.

/s/
Joseph Grow
Administrative Law Judge