SUBJECT:

Davis East,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

In this decision I incorporate by reference my ruling granting partial summary judgment to the Centers for Medicare & Medicaid Services (CMS) dated March 8, 2005 (ruling). Additionally, I find that CMS failed to establish a prima facie case that Petitioner, Davis East, did not comply with the requirement that it consult with a resident's physician about a significant change in that resident's medical condition. I find, therefore, that Petitioner did not contravene the physician consultation requirement of 42 C.F.R. � 483.10(b)(11).

The remedies that I sustain against Petitioner consist of the following:

� Per-instance civil money penalties of $8,000 and $2,000 to remedy Petitioner's noncompliance with the requirements of 42 C.F.R. �� 483.25 and 483.75;

� A per-instance civil money penalty of $2,000 to remedy Petitioner's noncompliance with the family notification requirement of 42 C.F.R. � 483.10(b)(11);

� Denial of payment for new admissions for each day of a period that began on January 27, 2004 and that ran through February 20, 2004;

� Loss of authority to conduct a nurse aide training and competency evaluation program (NATCEP).

I. Background

Petitioner is a skilled nursing facility doing business in Pine Bluff, Arkansas. It participates in the Medicare program. Its participation in Medicare is governed by sections 1866 and 1819 of the Social Security Act and by regulations at 42 C.F.R. Parts 483 and 488.

At issue in this case are findings of noncompliance with Medicare participation requirements that were made at surveys of Petitioner's facility that were completed on October 10, 2003 (October 2003 survey), December 4, 2003 (December 2003 survey) and January 23, 2004 (January 2004 survey). CMS determined to impose remedies against Petitioner based on these noncompliance findings. These included per-instance civil money penalties of $8,000 and $2,000 based on noncompliance findings made at the December 2003 survey and a per-instance civil money penalty of $7,500 based on noncompliance findings made at the January 2004 survey. Additionally, CMS determined to impose the remedies of denial of payment for new admissions and loss of authority to conduct NATCEP.

Petitioner requested a hearing and the case was assigned to me for a hearing and a decision. I scheduled a hearing, to be held on April 26, 2005, in Little Rock, Arkansas. CMS moved for summary judgment in advance of the hearing and Petitioner opposed the motion. I issued my ruling on March 8, 2005 granting CMS partial summary judgment. In my ruling I sustained imposition against Petitioner of civil money penalties of $8,000 and $2,000. I declined to sustain the imposition of a $7,500 per-instance civil money penalty against Petitioner or the other remedies that CMS determined to impose because there were disputed issues of material fact. I advised the parties that I would hold the in-person hearing as scheduled in order to address the remaining issues.

However, the parties then advised me that they wished to have the remaining issues heard and decided based on their written submissions. I afforded the parties the opportunity to file briefs addressing these issues and the parties did so.

CMS requested that I receive into evidence the following exhibits: CMS Ex. 1; CMS Ex. 7 - CMS Ex. 10; CMS Ex. 12; CMS Ex. 13; CMS Ex. 16 - CMS Ex. 20; CMS Ex. 25 - CMS Ex. 28; CMS Ex. 42; CMS Ex. 45; and CMS Ex. 47. CMS also requested that I receive P. Ex. 13; P. Ex. 14; and P. Ex. 22 into evidence. Petitioner requested that I receive P. Ex. 26 - P. Ex. 29; P. Ex. 14; P. Ex. 15; and P. Ex. 22 into evidence. ⁽¹⁾ I receive into evidence all of these exhibits.

II. Issues, findings of fact and conclusions of law

A. Issues

The issues remaining in this case are:

1. Whether Petitioner failed to comply substantially with the physician consultation requirement of 42 C.F.R. � 483.10(b)(11);

2. What civil money penalty amount is reasonable as a remedy for Petitioner's failure to comply with the family notification requirements of 42 C.F.R. � 483.10(b)(11); and

3. Whether CMS has the authority to impose additional remedies, consisting of denial of payment for new admissions and loss of NATCEP, against Petitioner.

B. Findings of fact and conclusions of law

I make findings of fact and conclusions of law (Findings) to support my decision in this case. I set forth each Finding below as a separate heading. I discuss each Finding in detail.

1. I adopt my March 8, 2005 ruling.

I incorporate into this decision all of the findings as to noncompliance and remedy that I made in my March 8, 2005 ruling.

2. CMS did not prove a prima facie case that Petitioner failed to comply with the physician consultation requirement of 42 C.F.R. � 483.10(b)(11).

The relevant portion of the regulation at issue here requires a facility immediately to consult with a resident's physician if 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).

42 C.F.R. � 483.10(b)(11)(i)(B)

CMS contends that Petitioner failed to comply with the consultation requirement in providing care to a resident who is identified in the report of the January 2004 survey as Resident # 1. The resident was a profoundly mentally retarded individual who was totally dependent for care on Petitioner's staff. CMS Ex. 26, at 2. CMS asserts that there were significant changes in the resident's medical condition over a period that commenced on December 16, 2003 and which continued until December 19, 2003. CMS contends that Petitioner's staff should have consulted with the resident's physician during this period but failed to do so until December 19, 2003. On that date the staff finally consulted with the physician, who ordered the resident be transferred to a hospital. The resident expired shortly after arriving at the hospital.

The allegedly significant changes that CMS asserts were present in the case of Resident # 1 consist of intermittent fevers and a decline in appetite. As to the resident's fevers CMS asserts that the resident's temperature never exceeded 99.8 degrees Fahrenheit during a period that ran from August through December 15, 2003. However, on December 16, 2003, the resident's temperature was recorded at 101.8 degrees. A nurse gave the resident Tylenol and the resident's temperature declined to 96.9 degrees. CMS Ex. 26, at 2; CMS Ex. 28, at 27. On December 17, 2003, the resident's temperature was recorded at 101.7 degrees. Tylenol was again administered and, within about two hours, the resident's temperature declined to 99.8 degrees. CMS Ex. 26, at 3; CMS Ex. 28, at 28. There are no records of the resident's temperature on December 18, 2003. On December 19, 2003 the resident's temperature was recorded at 101.1 degrees and the resident refused to take medication. Id.

With respect to the issue of food consumption CMS asserts that Resident # 1 displayed a marked decline in her appetite beginning with lunch on December 16, 2003. The resident consumed 75 percent of her breakfast on that date. However, she consumed only 25 percent of her lunch and 25 percent of her dinner. The resident refused to consume any of her meals on December 17, and only 25 percent of breakfast, lunch, and dinner on December 18, 2003. CMS Ex. 28, at 38. CMS contends that Resident # 1 displayed a much better appetite in the two week period prior to December 16, 2003 than she did subsequently. Id.

CMS argues that the resident's manifestation of an intermittent fever beginning on December 16, 2003 and her decline in appetite beginning on that same date constituted a significant change in the resident's condition. According to CMS, the sudden onset of Resident # 1's fever on December 16, 2003 "was a change in her health status." CMS Ex. 47, at 3. Moreover, the resident's fever coupled with her decreased meal intake "were signs that Resident # 1's health was deteriorating." Id. Petitioner's duty to consult with the resident's physician was not relieved, according to CMS, by the fact that the resident's fever responded to Tylenol. Id.

I am not persuaded by the foregoing evidence and analysis that CMS established a prima facie case that Resident # 1 manifested significant changes in her condition prior to December 19, 2003 that necessitated consultation by Petitioner's staff with the resident's physician. I am not concluding that the changes manifested by the resident - her intermittent fevers and loss of appetite - might not have been medically significant, especially when viewed in hindsight. I conclude, however, that CMS failed to prove that Petitioner's staff should have assessed these changes as being significant.

The regulation imposes on a facility an absolute duty to consult with a resident's physician whenever a resident manifests a significant change in his or her medical condition. It also defines a significant change in objective terms to be a deterioration in a resident's health, mental, or psychosocial status in either life-threatening conditions or clinical complications. But, the regulation does not state explicitly what benchmarks a facility's staff must use to determine whether a change in a resident's condition evidences a life-threatening condition or a clinical complication. Is an intermittent fever - albeit controlled by Tylenol - significant? Is a loss of appetite over a three-day period significant? Is the presence of both of these signs in tandem a significant change? The regulation does not contain any language which a lay person or an administrative law judge could use on his or her own to answer these questions.

What controls in a situation like this is the applicable nursing standard of care. Presumably, there are relevant nursing criteria that tell a nurse when a physician must be consulted about a patient's fever or about a patient's loss of appetite. But, I am neither a physician nor a nurse and I have no independent means of ascertaining what those criteria are. The burden is on CMS to establish the applicable standard of care. Absent proof of those criteria I am in no position to decide either what the applicable criteria are or how they would govern the evidence in this case.

CMS did not establish the applicable nursing standard of care that would govern the facts that it presented about Resident # 1. Absent such proof I am left to speculate as to what the facts offered by CMS mean and I may not do that consistent with my obligation to evaluate the evidence. Asserting that a resident's onset of fever signified a change in the resident's health status is not enough. CMS did not offer any evidence to explain why the fluctuations in the resident's temperature were sufficient to put Petitioner's staff on notice of a life-threatening condition or a clinical complication in the resident's condition. Similarly, CMS has not shown why a loss of appetite by a resident over a period of three days, accompanied by intermittent fevers, would apprize the staff of a life-threatening condition or a clinical complication.

Petitioner offered evidence which it contends proves affirmatively that the changes manifested by Resident # 1 before December 19, 2003 were not medically significant. ⁽²⁾ It is unnecessary that I address that evidence inasmuch as I find that CMS failed to meet its burden of establishing a prima facie case that the resident manifested significant changes prior to December 19, 2003.

3. A per-instance civil money penalty of $2,000 is a reasonable remedy for Petitioner's failure to comply with the family notification requirement of 42 C.F.R. � 483.10(b)(11).

In my ruling I withheld addressing the issue of what penalty amount would be reasonable to remedy Petitioner's noncompliance with the family notification requirements of 42 C.F.R. � 483.10(b)(11). CMS had determined to impose a per-instance civil money penalty of $7,500 against Petitioner based on its conclusion that Petitioner failed to consult with Resident # 1's physician and to notify Resident # 1's family about significant changes in the resident's clinical condition. In my ruling I found that there were disputed issues of fact about the physician consultation issue and I concluded that, consequently, it was premature to address the issue of penalty amount.

I have now decided that there is insufficient evidence to show that Petitioner failed to comply with the physician consultation requirement. The penalty amount must therefore be based solely on Petitioner's failure to comply with the family notification requirement.

I decide that a per-instance civil money penalty of $2,000 is a reasonable remedy to address this deficiency. The penalty that I have determined to sustain is relatively modest being only one fifth of the maximum permissible amount for a per-instance civil money penalty. It reflects the relative severity of Petitioner's noncompliance but it also is made in light of the absence of a prima facie case to show that Petitioner failed to consult with the resident's physician. The potential for harm is evident. It consists of emotional duress resulting from failure to notify Resident #1's family of a significant change in the resident's condition. Finally, I note that Petitioner has offered no argument to contest any of the penalty amounts - as opposed to the underlying issue of its noncompliance - determined by CMS. Petitioner has not suggested that any regulatory factor, including the seriousness of its deficiency, fails to support the imposition of a civil money penalty.

4. CMS is authorized to impose denial of payment for new admissions.

CMS is authorized to impose denial of payment for new admissions for any failure by a facility to comply substantially with a participation requirement or requirements. 42 C.F.R. � 488.417(a). In this case I have made findings that Petitioner failed to comply substantially with three distinct participation requirements. That failure authorizes CMS to impose denial of payment for new admissions. ⁽³⁾

CMS determined that the duration of the remedy was from January 27, 2004 through February 20, 2004. Petitioner has not challenged this aspect of CMS's determination.

5. CMS is authorized to deny Petitioner authority to conduct a NATCEP.

The possible grounds to deny a facility authority to conduct a NATCEP are set forth at 42 C.F.R. � 483.151(b)(2) and (3). ⁽⁴⁾ In this case, CMS contends that Petitioner's authority to conduct a NATCEP was appropriately denied because Petitioner was subject to a civil money penalty of more than $5,000. 42 C.F.R. � 483.151(b)(2)(iv). In this case I have sustained civil money penalties totaling $12,000, one of which, an $8,000 per-instance civil money penalty, exceeded $5,000 in and of itself. Loss of authority to conduct NATCEP is authorized in this case both by the aggregate penalty amount and by the individual penalty of $8,000.

Steven T. Kessel

Administrative Law Judge

1. CMS objected to my receiving Petitioner's exhibits P. Ex. 26 - P. Ex. 29 on the ground that they were filed untimely. I overrule CMS's objection and receive the exhibits. I note, however, that their contents have no bearing on my decision in this case. The exhibits address the issue of whether Petitioner failed to consult with a resident's physician about a significant change in the resident's medical condition and contain evidence which, arguably, goes to the question of whether the resident manifested a significant change. I find it unnecessary to weigh and address that evidence because I find that CMS failed to prove a prima facie case establishing the applicable standard of care with which Petitioner allegedly failed to comply.

2. The parties do not dispute that Resident # 1 was manifesting significant changes by December 19, 2003. In my ruling I found that Petitioner's failure to notify the resident's family of changes that the resident manifested on that date, including the necessity to transport the resident to a hospital, contravened the requirements of 42 C.F.R. � 483.10(b)(11).

3. Originally, CMS argued that authority for imposing denial of payment for new admissions lies in 42 C.F.R. � 488.417(b). This section mandates imposition of the remedy under certain circumstances. I observed in my ruling that it was unclear that a basis existed in this case for mandatory imposition of a denial of payment for new admissions but that a basis might be present for permissive imposition of the remedy.

4. To be precise, it is the State which denies a facility authority to conduct a NATCEP. The regulations provide that a State may not approve a facility's NATCEP under the enumerated circumstances.