SUBJECT:

Hamilton House Nursing Center,

Petitioner,

            - v -

Centers for Medicare & Medicaid Services

DECISION

I sustain the determination of the Centers for Medicare and Medicaid Services (CMS) ⁽¹⁾ to impose remedies against Hamilton House Nursing Center (Petitioner) for failure to comply substantially with federal requirements governing participation of long term care facilities in Medicare and Medicaid programs. This proceeding concerns the imposition of a civil monetary penalty (CMP) of $50.00 a day commencing December 2, 1998, through February 26, 1999, for a total of $4,350.

I. Background

This case came before me pursuant to a request for hearing filed by Petitioner on March 29, 1999, in accordance with section 1128A(c)(2) of the Social Security Act (Act) and 42 C.F.R. §§ 488.408(g) and 498.40.

On February 23, 1999, CMS informed Petitioner that it was imposing a CMP due to its failure to be in substantial compliance with the applicable federal requirements for nursing home participants. CMS Exhibit (Ex.) 5. An annual survey of Petitioner's facility, on December 2, 1998, found a lack of compliance with quality of care requirements under 42 C.F.R § 483.25(m)(1). A second revisit survey, completed on April 19, 1999, revealed that the facility had achieved substantial compliance with all regulatory requirements as of February 27, 1999.

During a telephone conference convened by Administrative Law Judge (ALJ) Marc R. Hillson on December 8, 1999, the parties agreed that an in-person hearing was unnecessary. The parties also agreed to establish dates for document exchanges, including the submission of statements or affidavits in lieu of testimony, and to file simultaneous briefs.

Each party submitted written briefs in support of their respective contentions. CMS offered twelve proposed exhibits, and Petitioner offered sixteen proposed exhibits. ⁽²⁾ On April 29, 1999, Petitioner added a twenty two page unmarked exhibit consisting of a second affidavit by Mr. Burnis D. Breland with attachments purporting to be the results of Sucralfate studies. Petitioner objected to CMS Exs. 1 to 7; 11 and 12. Petitioner's objections to Exs. 1 to 7 are not predicated on lack of authenticity or irrelevance, but on grounds of hearsay and the weight to be given to those documents. ⁽³⁾ I fail to see the objection to CMS Exs. 1 and 2 inasmuch Petitioner submitted the same document as P. Exs. 1 and 2. Additionally, CMS Ex. 7 is an affidavit offered in lieu of testimony as agreed to by the parties. CMS Ex. 11 is an excerpt from the PDR Nurse's Drug Handbook, and Ex. 12 is an excerpt from Drug Facts and Comparisons. Petitioner objected to these excerpts as being irrelevant to the case. I find that they are no less relevant than the pharmacological information provided by Petitioner at Exs. 8, 13 and 14 regarding Carafate, Motrin, and Ibuprofen. ⁽⁴⁾ The questioned documents contain the commonly accepted standards in the medical and pharmaceutical communities for prescription and administration of medications. I, therefore, admit into evidence CMS Exs. 1-12. They all meet the test of authenticity and relevance. Petitioner's objections grounded on hearsay are without merit in view of the strict inapplicability of the rules of evidence to administrative proceedings. See 42 C.F.R. § 498.61.

CMS, in turn, objected to P. Exs. D(4) and E(5) because they were neither signed nor sworn to be the genuine statements from the purported affiants. I note, however, that those statements are signed and sworn to before a notary. CMS objected to "Petitioner's Table of Contents" ⁽⁵⁾ as well as P. Exs. A(1), C(3), D(4), E(5), F(6), G(7), J(10), K(11), and L(12) because the residents' names were not redacted. I find that to be insufficient grounds for rejection of those documents as admissible. ⁽⁶⁾ Consequently, I admit into evidence Petitioner's Exs. 1-17.

II. Standard for Summary Judgment

Summary judgment is appropriate when there is no genuine issue as to any material fact and the proponent is entitled to judgment as a matter of law. Fed. R. Civ. P. 56. If the moving party meets this burden, the onus shifts to the opposing party to establish that a genuine issue does exist. The opposing party will have shown that genuine issues of fact are present "if the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 249 (1986). To accomplish this, the opposing party must go beyond mere allegations, and come forward with factual evidence that creates a genuine issue of material fact. All reasonable inferences are to be drawn in the opposing party's favor. Pollock v. American Tel. & Tel. Long Lines. 794 F.2d. 860, 864 (3^rd. Cir. 1986). I have considered all the evidence set forth in the papers submitted, and conclude that all inferences drawn from such evidence, casts no doubt as to the propriety of granting HCFA's motion for summary judgment inasmuch as there is no issue of material fact to be tried. CMS's motion is properly supported by affidavits and documentary evidence.

III. Applicable Law and Regulations

Petitioner is considered a long term care facility under the Act, and regulations promulgated by the Secretary of Health and Human Services (Secretary). The statutory requirements for participation by a long term care facility are found at sections 1819 and 1919 of the Act, and Title 42 C. F. R. Part 483.

Sections 1819 and 1919 of the Act invest the Secretary with authority to impose a CMP against a long term care facility for failure to comply substantially with participation requirements.

Pursuant to the Act, the Secretary has delegated to CMS and the States the authority to impose remedies against a long term care facility that is not complying substantially with Federal participation requirements. Part 483 of 42 C. F. R. provides that facilities which participate in Medicare may be surveyed on behalf of CMS by State survey agencies in order to ascertain whether the facilities are complying with participation requirements. 42 C. F. R. §§ 488.10 - 488.28. The regulations contain special survey conditions for long term care facilities. 42 C. F. R. §§ 488.300 - 488.335. Under Part 488 a State or CMS may impose a CMP against a long term care facility where a State survey agency ascertains that the facility is not complying substantially with participation requirements. 42 C. F. R. §§ 488.406, 488.408, 488.430. The penalty may start accruing as early as the date that the facility was first out of compliance until the date substantial compliance is achieved or the provider agreement is terminated. 42 C. F. R. § 440(a)(b). Section 488(f) of 42 C. F. R. sets forth the factors in determining the amount of the CMP imposed for each day of noncompliance.

The Act and regulations make a hearing available before an ALJ to a long term facility against whom CMS has determined to impose a CMP. Section 1128A(c)(2) of the Act, 42 C. F. R. §§ 488.408(g), 498.3(b)(12) and (13). The hearing before an ALJ is a de novo proceeding. Anesthesiologists Affiliated, et al, DAB, CR 65 (1990), aff'd 941 F2d. 678 (8^th Cir. 1991).

IV. Issues

The issues in this case are whether:

a) a basis exists to impose a civil money penalty against Petitioner;

b) assuming that a basis exists to impose a civil money penalty, what is the reasonable amount?

V. Findings and Discussion

The findings of fact and conclusions of law noted below in italics are followed by a discussion of each finding.

1. The facility was not in substantial compliance with federal participation requirements from December 2, 1998 through February 26, 1999.

The applicable regulations at 42 C.F.R. § 483.25, entitled "Quality of care," provides:

[e]ach resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psycho social well-being, in accordance with the comprehensive plan of care.

Consistent with that requirement, 42 C.F.R. § 483.25(m)(1) provides that the facility must ensure that it is free of medication error rates of 5 percent or greater. Based on observations and record review, the State surveyors determined that the facility failed to ensure it was free of medication errors of 5 percent or greater, as evidence, by the following examples under F-Tag 332:

a. Resident "R" ⁽⁷⁾

Resident R had been prescribed Reglan 10 mg. to be given 30 minutes before meals. During the revisit survey of February 3, 1999, Ms. Rebecca A. DeVine, a surveyor with the Georgia Department of Human Resources, observed staff administer the medication at 12:30 p.m., after the lunch meal. Dialogue with facility and staff as well as the resident, confirmed that after the meal the medication that was given was Reglan. CMS Exs. 1, 7.

Petitioner does not contest the medication error regarding the administration of Reglan to Resident R. Thus, I find that the facility incurred a medication error as to this resident.

b. Resident "M"

Resident M had been prescribed Motrin 800 mg. to be given with food, but this medication was administered with water only, according to the surveyor's observation. An interview with a snack nurse and a Certified Nurse Assistant (CNA) at the time revealed that the resident had not eaten a midmorning snack. CMS Exs.1, 7.

In her affidavit, Ms. Rebecca A. Devine, states that during the conduct of the survey on February 3, 1999, she followed the medication nurse to observe whether the administration of medications to residents of the facility was done in accordance with the physician's orders. Contrary to those orders, Motrin 800 mg. was given at 11:30 a.m. with water only. She concluded that the facility's failure to follow the resident's physician's orders created a potential for more than minimal harm. CMS Ex. 7.

Petitioner contends that "if" Resident M received a snack on the morning of February 3, 1999, it would be highly improbable that it was given to her less than 45 minutes after it was delivered to the floor. ⁽⁸⁾ Petitioner also claims that any CNA responsible for the care of Resident M who failed to give her a snack would be reprimanded because the administration of that meal was necessary for the dietary control of her diabetes. P. Ex. 4, affidavit of Bobbie Crouch.

Petitioner's pharmacist, Burnis D. Breland, picks up on the assumption of Bobbie Crouch to conclude that since Resident M had a snack at 10:45 a.m. she would have retained enough stomach contents at 11:30 a.m., when Motrin was given. That being the case, says Petitioner's pharmacist, the medication was administered consistent with the physician's intent that the medication be given with food. P. Ex 12.

In support if its contention that Resident M was properly medicated on February 3, 1999, Petitioner also submitted an affidavit of the prescribing physician, Dr. Deborah A. Daniels. The treating physician states that although she prescribed Motrin to be taken with food, she is not aware of any direction in the manufacturer's instruction for use of the medication requiring that it be given with food. She acknowledged, however, that Ibuprofen (Motrin) can sometimes cause gastrointestinal problems, and its administration with meals tends to minimize or eliminate such adverse reactions. Furthermore, Dr. Daniels pointed out that Resident M has never suffered from gastrointestinal problems nor has the administration of Ibuprofen been the cause of gastrointestinal complaints. Specifically, it is Dr. Daniel's position that the Ibuprofen given to Resident M on February 3, 1999, caused no discomfort, and even if taken without food, did not jeopardize her health. P. Ex. 11.

I am more persuaded by the facility staff's admission to the surveyor that Resident M did not have a snack prior to the administration of Motrin, rather than the notion that staff would never have the resident skip her snack because she was a known diabetic dependent on dietary control. In order to accept Ms. Crouch's explanation at P. Ex. 4, I would have to attribute perfection to the facility. However, Petitioner acknowledges that the staff made errors when it admits that Resident R was not given Reglan until after lunch, when the instructions were unequivocal that the medication had to be given before the meal. Ms. Crouch's implication that the absence of a reprimand for failure to give resident M Motrin without a snack is evidence that a snack was given, turns weak when we consider that there is no evidence of a reprimand for failure to administer Reglan to the resident after the meal rather than before. CMS Ex. 2 at 4. Conclusions based on the custom and habit of providing residents with a mid morning snack, must yield to the fact that no snack was given to Resident M, based on the statement of a CNA who interacts more closely with the residents than the Nurse Manager, Ms. Bobbie Crouch.

In view of the foregoing, the statement of the pharmacist, Burnis D. Breland, at P. Ex. 12 is of little probative value. The opinion of the pharmacist to the effect that there was compliance with the physician's order because Motrin was given with a snack is grounded on an unacceptable claim by Petitioner.

Dr. Daniels recognizes that she prescribed Ibuprofen to Resident M to be given with food, but says she is unaware of any direction in the manufacturer's instructions for use of the medication requiring that it be given with food. However, as a physician, Dr. Daniels appears to be aware that in order to take appropriate precautions when administering medications, it is necessary to go beyond a direct mandate by the manufacturer. But even if she was guided only by the manufacturer's instructions when prescribing Ibuprofen to Resident M, she must have been influenced by the manufacturer's warning that this medication can cause gastrointestinal discomfort, and in more extreme cases gastrointestinal bleeding, which may result in hospitalization and even fatal outcomes. P. Ex. 13 at 2. Consequently, her instruction that the medication be given with food was a very wise one indeed. This is particularly more evident in the case of Resident M, who was on long term Motrin use at the highest available dosage of 800mg. P. Ex. 13 at 3. When Dr. Daniels admitted Resident M to Petitioner's facility on May 1, 1998, she immediately placed her on Motrin 800mg., three times a day.

I infer that the high dosage, prescribed over an extended period of time, prompted Dr. Daniels to take the precaution to instruct that the medication be given with food. P. Ex 10 at 2,3,4, and 6.

Dr. Daniels' assertion that it has never been brought to her attention that Ibuprofen has ever caused resident M gastrointestinal problems overlooks the fact that since the onset of Ibuprofen administration, she had ordered that the medication be given with food. Thus, the fact that Resident M had not experienced gastrointestinal discomfort with Ibuprofen ingestion while taking the medication with food, should support a continuation of the practice, rather than departing from it. It is true, as Dr. Daniels says in her affidavit, that the administration of Ibuprofen on February 3, 1999, without food did not jeopardize, her health or safety. Nonetheless, a departure from the treating physician's clear order to administer Ibuprofen with food, creates the potential for more than minimal harm. P. Ex. 11 at 2. A change in the way medications are administered, should not take place in the absence of consultation with the treating physician. I doubt that if consulted, Dr. Daniels would have agreed to do away with the practice of giving Ibuprofen with food. Therefore, I fail to see why she would condone the facility's lack of adherence to her specific instructions.

c. Resident "C"

Resident C had been prescribed Carafate 1mg. to be given one hour before meals. During the revisit survey of February 3, 1999, the surveyor, Ms. Rebecca A. DeVine, observed the medication nurse administer Carafate 20 minutes before the lunch meal. She concluded that the facility's failure to follow the treating physician's orders created a potential for more than minimal harm. CMS Ex. 1 at 1; CMS Ex. 7 at 1.

In her affidavit, Ms. DeVine states that Carafate was given to the resident at 11:50 a.m., that is, 20 minutes before lunch as opposed to one hour before lunch as ordered by the prescribing physician. CMS Ex. 7 at 1, ¶ 8. Petitioner, however, assumes that Ms. DeVine stated that Carafate was administered 20 minutes before the food trays were delivered in front of the third floor elevator of the facility. Thus, Petitioner relies on the elaborate explanation of Ms. Marcia Walker regarding the tray flow from the moment of their arrival at the floor, in order to conclude that more than 20 minutes must have elapsed between Carafate administration and the lunch meal. This departure from Ms. DeVine's report on the statement of deficiencies (CMS Ex. 1), as well as her affidavit, forms the basis of Petitioner's theory as to why Resident C was given Carafate more than 20 minutes prior to lunch. However, even if Petitioner can establish that Carafate was given 40 minutes before the noon meal, it has offered no explanation as to why it did not follow the treating physician's instructions to give the medication one hour meal before the meal.

In his affidavit, Dr. Gregory A. Foster says that Carafate is to be taken on an empty stomach in order that it may form a barrier around an ulcer, creating a paste like film that promotes healing. He adds that even if the medication is taken 20 minutes prior to meal ingestion this purpose is accomplished. He further surmises that the nurses employed at Petitioner's facility would understand the order given by Dr. Mitchell, the prescribing physician, to mean that the one hour time interval is not critical, but that administration prior to a meal is all that is required. P. Ex. 7.

It is Dr. Foster's opinion that although the physician's order specifically indicates administration one hour before meals, his understanding of the literature regarding the drug and his experience is that the drug be given on an empty stomach. He further asserts that he is unaware of any direction in the manufacturer's instructions for use of the medication requiring anything beyond his stated interpretation. It is true that the manufacturer's instructions say that Carafate should be taken on an empty stomach, without defining what is meant by an empty stomach. P. Ex. 8 at 4. How the medical and pharmaceutical communities define the term "empty stomach," is found at CMS Ex. 12. The excerpt is from the type of publication that Dr. Foster surely had in mind when in his affidavit he stated that he had an "understanding of the literature regarding the drug." The publication from which it is taken is entitled Drug Facts and Comparisons, by Walters Kluwer Company ( updated monthly). This work is a comprehensive drug information compendium which I find it to be the resulting distillate of a plural intelligence. Its learned editorial board engages in continual review of approved Food and Drug Administration product labeling, thousands of biomedical journal articles and textbooks, and policies and recommendations from many authoritative and official groups, such as the Centers for Disease Control; the National Academy of Sciences; the Joint National Committee on Detection; and the Food and Drug Administration. CMS Ex. 12. Drug Facts and Comparisons defines empty stomach as "at least one hour before meals or at bedtime." I understand this authoritative literature to mean that less than one hour before meals is unacceptable.

Dr. Foster's assertion that nurses are at liberty to disregard specific physicians' medication administration instructions is without merit. The PDR Nurse's Drug Handbook, another publication that I am certain Dr. Foster is familiar with, is an authoritative source relied upon by the nursing profession. That publication defines empty stomach as one hour before or two hours after meals. Additionally, this handbook instructs that the medication should be taken exactly as prescribed. If the nursing staff wanted to deviate from specific physicians' medication instructions, they could not do it without prior consultation with Dr. Mitchell. Nurses are not to make medical judgments as to the point before mealtime at which a medication that has to be given on an empty stomach, would still be efficacious. The medical and pharmaceutical communities have developed standards of acceptable practice to assist care givers in staying within safe parameters. Nurses are not to substitute their judgment for that of the professionals who have developed such standards and the physicians that apply them. A facility that allows nurses to take such liberties, treads on thin ice. In the case at hand, I find no support for the revisionist approach taken by Petitioner. Although it has not been shown that Resident C suffered actual harm, the medication error in this case has the potential for more than minimal harm.

Petitioner argues that Dr. Burnis D. Breland's affidavit supports the view that Carafate administered with food can still be efficacious. P. Ex. 12, P. Brief (Br.) at 12. However, I could not find such an assertion from a reading of Dr. Breland's statement. Moreover, none of the studies that accompany his affidavit support the view that Carafate should be prescribed to be taken with or without food. ⁽⁹⁾ More importantly, there is no support that nurses are free to disregard specific prescription instructions of treating physicians. That is the issue here. Petitioner does not dispute that it did not give Carafate to Resident C as directed by the physician. The failure to do so constitutes medication error. Arguments concocted in the aftermath that are directed at attempting to show that a deviation from the physician's instructions is of no consequence are unavailing.

I agree with CMS that Petitioner's application of F-Tag 333 (significant medication error) to the facts of this case is mistaken. This case concerns a medication error under F- Tag 332 (5 per cent medication error rate). Under F-Tag 332, CMS need not establish that the error caused the resident discomfort or jeopardized his or her safety. CMS need only establish that a variance exists between what the physician prescribed and what the surveyors observed. That discrepancy serves as a basis for the finding that such error creates a potential for more than minimal harm. CMS Ex. Ex. 10, P. Br. at 10.

2. The amount of the penalty imposed by CMS is reasonable.

CMS imposed a $50 per day CMP for the period beginning December 2, 1998 through February 26, 1999, the last day before correction and compliance occurred. There is no issue in this case as to the reasonableness of the daily amount of the penalty inasmuch as $50 is the minimum that may be imposed by CMS where it is established that the participating facility incurred a deficiency that posed a potential for more than minimal harm to residents, but not at the immediate jeopardy level. 42 C.F.R. § 488.438(a)(ii). Moreover, Petitioner has not contested the CMP imposed in this case.

Conclusion

I conclude that CMS correctly determined that beginning December 2, 1998 through February 26, 1999, Petitioner was not complying with federal participation requirements in the Medicare program and the imposition of a CMP of $50 per day is reasonable for deficiencies that posed a potential for more than minimal harm, but not at the immediate jeopardy level.

José A. Anglada

Administrative Law Judge

1. Effective July 5, 2001, the Health Care Finance Administration was renamed the Centers for Medicare and Medicaid Services, and the rule provided that all references to "HCFA" are revised to read "CMS." 66 Fed. Reg. 35437.

2. Petitioner marked its exhibits with letters from "A" to "P." I have re-labeled them with numbers in conformity with Civil Remedies Procedures. Exhibit "Q" was excluded as it is merely the certificate of service.

3. Petitioner correctly points out that CMS Ex. 2 mistakenly refers to the error rate as 9% as opposed to 7.3 %, which is the percent of error claimed by CMS throughout these proceedings. The mistaken reference to 9% error rate does not taint the whole document.

4. Ibuprofen is the active ingredient in Motrin.

5. The Table of Contents submitted by Petitioner is not an exhibit in this case.

6. To protect the residents' privacy, however, the documents will be redacted where appropriate.

7. For privacy purposes I will refer to each resident by the first letter of the medication in question as CMS has done.

8. The import of this conjecture appears to be aimed at showing a closeness between the alleged snack and the administration of the Motrin.

9. It is safe to say that the studies submitted do not stand for the proposition suggested by Petitioner, even though the copies provided had missing pages.