Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
|IN THE CASE OF|
||DATE:July 26, 2004|
- v -
for Medicare &
| Docket No. A-04-35
Civil Remedies CR1097
Decision No. 1934
FINAL DECISION ON REVIEW OF
Comprehensive Professional Home Visits (Comprehensive), a home health agency (HHA) in Vallejo, California, appealed an October 17, 2003 decision by Administrative Law Judge Alfonso J. Montano (ALJ). Comprehensive Professional Home Visits, DAB CR1097 (ALJ Decision). The ALJ Decision sustained the determination of the Centers for Medicare & Medicaid Services (CMS) terminating Comprehensive's participation as a provider of home health services in the Medicare program under Title XVIII of the Social Security Act. Based on the results of a survey conducted by the California Department of Health Services (State Agency), CMS determined that Comprehensive was out of compliance with several Medicare conditions of participation, including one at the immediate jeopardy level. Further, CMS determined that the documented deficiencies substantially limited Comprehensive's capacity to render adequate care or adversely affected patient health and safety. Consequently, CMS imposed a termination remedy.
Based on the analysis below, we sustain the ALJ Decision imposing the termination remedy and, in doing so, affirm and adopt the findings of fact and conclusions of law (FFCLs) made by the ALJ.
Factual and Procedural Background
CMS based its decision to terminate on the results of the State Agency's June 22, 1999 survey of Comprehensive. By letter dated July 28, 1999, CMS notified Comprehensive that it no longer met the requirements for participation as a Medicare provider of home health services. CMS informed Comprehensive that it planned to terminate Comprehensive's Medicare provider agreement effective August 6, 1999. However, CMS held out the possibility that the termination could be avoided if, by August 2, 1999, Comprehensive were to submit, to CMS's regional office and to the State Agency, credible documentation evidencing correction of all of the deficiencies cited on the standard survey report and if CMS could verify those corrections through a resurvey. Comprehensive subsequently submitted documentation alleging correction of the deficiencies. After reviewing that documentation, CMS informed Comprehensive that it found no basis for revising its determination. Comprehensive's Medicare provider agreement was terminated August 6, 1999. ALJ Decision at 1-2.
By letter dated August 28, 1999, Comprehensive filed a request for an administrative hearing to review CMS's determination. Comprehensive was represented by its Administrator throughout these proceedings. (1) Following procedural delays and the general travel moratorium attributable to the events of September 11, 2001, the ALJ held a hearing in San Francisco in May 2002. ALJ Decision at 2-5.
Medicare includes "home health services" provided by a "home health agency" as described in section 1861(m) of the Social Security Act (Act). The term "home health agency" is defined in section 1861(o) of the Act.
Regulations which govern the participation of HHAs in the Medicare program are in 42 C.F.R. Part 484. Specifically, the provisions in 42 C.F.R. §§ 484.10 through 484.52 set forth the requirements for Medicare participation of HHAs and establish conditions of participation for these entities. The regulations express these conditions of participation as broadly stated participation criteria. The regulations also state standards of participation as subsidiary components of the conditions of participation.
CMS, on behalf of the Secretary, is required to determine whether a Medicare provider of services, including a HHA, is complying substantially with the Medicare participation requirements established by the Act and regulations. Section 1866(b)(2) of the Act. In order to remain certified as a Medicare provider, a HHA must remain in substantial compliance with all conditions of participation.See 42 C.F.R. §§ 489.53(a)(1) and (3).
The process and criteria for determining whether a provider is complying substantially with Medicare participation requirements are established by regulations contained in 42 C.F.R. Part 488. CMS has entered into agreements with State survey agencies, pursuant to the Act and regulations, to conduct periodic surveys of providers, including HHAs, in order to ascertain whether the providers are complying with Medicare participation requirements. Section 1864(a) of the Act; 42 C.F.R. §§ 488.10, 488.11 and 488.20.
State survey agencies conduct surveys of HHAs and make recommendations to CMS as to whether such facilities meet federal participation requirements for the Medicare program. Section 1864(a) of the Act; 42 C.F.R. §§ 488.10, 488.11 and 488.20. CMS considers survey results from the State survey agencies as the bases for its determinations regarding the initial or continued participation of a HHA in the Medicare program. 42 C.F.R. §§ 488.11 and 488.12.
In determining whether a provider complies with a particular condition of participation, the State survey agency evaluates the manner and degree of the provider's satisfaction of the various standards within each condition. 42 C.F.R. § 488.26(b). The State survey agency documents its findings on HCFA Form 2567, which the provider receives after the survey is completed. 42 C.F.R. § 488.12. The State survey agency also makes a recommendation to CMS as to whether there is a basis for termination. CMS may accept or reject the recommendation after reviewing the survey findings.
CMS may terminate participation in Medicare when it determines, either on its own initiative or based on a State survey agency report, that a provider is not complying with one or more Medicare conditions of participation. Section 1866(b)(2)(A) of the Act; see 42 C.F.R. §§ 488.20, 488.24 and 488.26 and 489.53(a)(1) and (3). Failure to comply with a condition of participation occurs where deficiencies, either individually or in combination, are "of such character as to substantially limit the provider's . . . capacity to furnish adequate care or which adversely affect the health and safety of patients . . . ." 42 C.F.R. § 488.24(b).
"Immediate jeopardy" is defined as a situation in which a provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident. 42 C.F.R. § 489.3.
The ALJ Decision was based on the following two numbered FFCLs:
FFCL 1 concerned deficiencies, involving two patients, which were found to constitute immediate jeopardy to the patients' health and safety. The ALJ also identified in the text of the decision several non-immediate jeopardy deficiencies that Comprehensive had admitted or conceded. The ALJ agreed with CMS that these deficiencies individually, or in combination, were "of such a character as to substantially limit Petitioner's capacity to furnish adequate care to patients and adversely affect patient health and safety." ALJ Decision at 16.
Although Comprehensive specifically excepted only to FFCL 1, it necessarily follows, and it is clear from its arguments, that Comprehensive excepted to FFCL 2 as well.
Our standard of review on a disputed conclusion of law is whether the ALJ Decision is erroneous. Our standard of review on a disputed finding of fact is whether the ALJ Decision is supported by substantial evidence on the record as a whole. Guidelines for Appellate Review of Decisions of Administrative Law Judges Affecting a Provider's Participation in the Medicare and Medicaid Programs, http://wwww.hhs.gov/dab/guidelines/prov.html; see, e.g., Fairfax Nursing Home, Inc., DAB No. 1794 (2001), aff'd, Fairfax Nursing Home v. Dep't of Health & Human Srvcs., 300 F.3d 835 (7th Cir. 2002), cert. denied, 2003 WL 98478 (Jan. 13, 2003).
Under the general heading "Immediate Jeopardy (G-Tag 164)," the ALJ examined allegations regarding two individuals identified as Patients No. 8 and No. 6. Specifically, the ALJ found that CMS established that Comprehensive was out of compliance with 42 C.F.R. § 484.18(b) at the immediate jeopardy level. According to the ALJ, Comprehensive's failure to comply with the requirements of participation relative to the care of Patient No. 6 and Patient No. 8 presented situations which were likely to cause serious injury, harm, impairment, or death. ALJ Decision at 14.
The regulation at 42 C.F.R. § 484.18 establishes a condition of participation titled "Acceptance of patients, plan of care, and medical supervision." At the outset, the regulation provides:
The standard set out at 42 C.F.R. § 484.18(b) provides for "[p]eriodic review of plan of care" and requires that:
Below, we address the patients in the order followed by the ALJ.
Patient No. 8
Patient No. 8, a 71-year old female, had a history of serious medical conditions including diabetes. ALJ Decision at 9; HCFA (2) Ex. 15 at 23; Hearing Transcript (Tr.) at 184.
During the June 22, 1999 survey, the State Agency surveyor observed that Patient No. 8's plan of treatment required, among other things, that she receive insulin injections twice a day, and a finger stick blood glucose test every skilled nursing visit, and that her physician be notified if her blood glucose level was below 60 mg./dl. or over 200 mg./dl. (3) HCFA Ex. 15, at 7-8; Tr. 185. The surveyor further found that during these separate skilled nursing visits, Patient No. 8's blood glucose level exceeded 200 mg./dl., but there was no indication in the nurses notes that the physician was contacted. HCFA Ex. 15, at 10-12; Tr. 185-190. Based on these findings, CMS alleged that Comprehensive failed to follow Patient No. 8's plan of treatment, thus endangering her health and safety at the immediate jeopardy level. ALJ Decision at 10.
CMS also asserted that, on at least two occasions, Patient No. 8 was given insulin on a sliding scale basis when Comprehensive did not have a physician's order approving the use of insulin on a sliding scale regimen. Further CMS contended that Comprehensive failed to regularly monitor Patient No. 8's blood glucose levels, as required by the plan of treatment. Id. (citations omitted).
Before the ALJ, Comprehensive argued that Patient No. 8's physician had wanted to be contacted if the patient's blood glucose was over 350 mg./dl. According to Comprehensive, however, a medical clerk incorrectly wrote 200 mg./dl. as the upper limit to the range, on the patient's plan of treatment. Comprehensive admitted its failure to obtain a physician's order for sliding scale insulin, but explained that the registered nurse "thought she had done the proper report back to the doctor." HCFA Ex. 15, at 33. Comprehensive also explained that on June 18, 1999, the nurse did not conduct a blood glucose test because the client had just eaten lunch. Thus, Comprehensive argued, the test would have been inaccurate. ALJ Decision at 10-11.
The ALJ determined that --
ALJ Decision at 10 (footnote omitted).
The ALJ found that CMS established a prima facie case that Comprehensive failed to comply with 42 C.F.R. § 484.18(b) in that Comprehensive both failed to follow the care plan and failed to promptly alert the physician of any changes that suggested a need to alter Patient No. 8's care plan. The ALJ found that Comprehensive did not rebut CMS's prima facie case by a preponderance of the evidence. The ALJ placed "no weight on Petitioner's unsubstantiated assertions . . . relative to this issue." The ALJ determined that "Petitioner's arguments and explanations were wholly inadequate to meet its burden [to overcome CMS's prima facie case]." He noted that Comprehensive had -
ALJ Decision at 11.
Thus, the ALJ concluded, Comprehensive's failure either to alert the physician of changes in Patient No. 8's condition (as required by the plan) or to inquire if the plan of care should be changed presented a situation which was likely to cause serious injury, harm, impairment, or death. ALJ Decision at 11.
On appeal, Comprehensive noted that, while in the hospital, Patient No. 8 had an established insulin dosage regimen. Comprehensive maintained, however, that upon meeting with the Home Health Nurse (HHN), Patient No. 8 presented the nurse with instructions for a sliding scale insulin regimen. Comprehensive admitted that this "medication was not in the written discharge order of the doctor given to us. But this order was given to the patient and the patient had used it for 2 days at home when we admitted her to our services." Comprehensive Br. at 7-8. Comprehensive asserted that, after receiving the order from Patient No. 8, the HHN called Patient No. 8's physician to discuss Patient No. 8's insulin regimen. Comprehensive further asserted on appeal that the doctor established an upper level blood glucose parameter of ">400mg/dl" as the point at which he should be notified. Given the doctor's orders, Comprehensive effectively stated that it saw no reason to adhere to the ">200mg/dl" parameter which, it asserted, had been entered erroneously in Patient No. 8's plan of treatment. Id. at 8.
Comprehensive discounted CMS's concerns about Patient 8 lapsing into a diabetic coma, noting that the patient was receiving two kinds of insulin (impliedly arguing that such a regimen would preclude the continual high blood glucose precipitating a diabetic coma) and that the HHN was following "the medicine's instruction . . . not the erroneously typed number by the medical clerk." Comprehensive Br. at 9.
Comprehensive's arguments do not show that the ALJ's analysis of the applicable law was erroneous nor do they demonstrate that the ALJ's factual findings were not supported by substantial evidence on the record as a whole. Specifically, Comprehensive cited no evidence supporting its version of the circumstances surrounding Patient No. 8's treatment. The ALJ cited Patient No. 8's plan of treatment as proof that the physician was to be contacted if her blood glucose readings dropped below 60 mg./dl. or rose above 200 mg./dl. See ALJ Decision at 10. Although Comprehensive alleged that a medical clerk had entered an incorrect figure as the upper limit to this range, as the ALJ noted, Comprehensive failed to provide either testimony or an affidavit from the physician or the medical clerk alleged to have entered the incorrect figure. Not only did Comprehensive fail to produce evidence before the ALJ to support its position there that the correct upper limit of that range was 350 mg./dl., but also, on appeal Comprehensive has now asserted that the correct upper limit was 400 mg./dl. See Comprehensive Br. at 8. However, the evidence supports CMS's assertion as to the upper limit blood glucose reading (200 mg./dl.) necessary for triggering a call to Patient No. 8's physician under the plan of care, which Comprehensive was to have developed with the attending physician and to have either followed or get changed, if necessary. See HCFA Ex. 15, at 8.
Regarding the administration of sliding scale insulin to this patient, Comprehensive admitted before the ALJ that it had failed to obtain a physician's order for this medication. See ALJ Decision at 11; HCFA Ex. 15, at 33. Comprehensive asserted that the HHN had discussed and resolved this situation with the patient's physician, but did not point to anything in the record which established that the physician had ordered this course of medication for Patient No. 8 at home. Comprehensive also referenced one page of the patient's chart, while in the hospital, as evidence of the patient's course of treatment upon her discharge. Comprehensive Reply Br. at 2; HCFA Ex. 15, at 27. The referenced page from Patient No. 8's hospital chart does in fact reflect various insulin dosages, including, apparently, a sliding scale application. However, Comprehensive offered no explanation as to how the treatment reflected on the hospital chart carried over to the patient's post-discharge regimen. If the discharge orders were viewed as establishing the plan of care for home health services, then they should have been reflected in the plan of care. Further, this hospital chart does not overcome the fact that, as the ALJ noted, Comprehensive admitted that it had failed to obtain a physician's order for application of sliding scale insulin. ALJ Decision at 11, citing HCFA Ex. 15 at 33.
Accordingly, we sustain the ALJ's finding that Comprehensive failed to substantially comply with 42 C.F.R. § 484.18(b) with respect to Patient No. 8.
Patient No. 6
Patient No. 6, a 64-year-old female, had a history of serious medical conditions including a laryngectomy and cancer with metastasis to the lung. ALJ Decision at 11; Tr. at 212.
The regulation at 42 C.F.R. § 484.18(b) establishes a standard requiring periodic review of a patient's plan of care. Pertinent here, HHA staff are required to "review" the plan of care "as often as the severity of the patient's condition requires" and to "promptly alert the physician to any changes that suggest a need to alter a plan of care."
The surveyors found there "was no documented evidence that the skilled nurse clarified [any unclear instructions] with the physician regarding oxygen concentration, mode of delivery" before beginning to implement the plan of care. HCFA Ex. 1 at 57. CMS alleged that the plan of care required clarification at the time the patient began home health care following her hospital stay. CMS Br. at 14.
The ALJ found that CMS had established a prima facie case that Comprehensive failed to comply with 42 C.F.R. § 484.18(b) and that Comprehensive's arguments fell "far short" of rebutting CMS's prima facie case. The ALJ also found that Comprehensive's failure to comply with the requirements of participation in this instance presented a situation which was likely to cause serious injury, harm, impairment, or death. Consequently, the ALJ sustained CMS's deficiency finding with respect to this participation requirement (G-Tag 164) at the immediate jeopardy level. ALJ Decision at 13-14.
The ALJ determined that -
ALJ Decision at 12.
On appeal, Comprehensive questioned CMS's finding of immediate jeopardy for Patient No. 6. See generally Comprehensive Br. at 10-22. Comprehensive asserted that the orders for Patient No. 6's oxygen administration were in place before its involvement in her care. Thus, Comprehensive did not consider them "an order for us." Comprehensive Br. at 12. Comprehensive also alleged that Patient No. 6's physician was on vacation, precluding it from contacting the physician directly with its concerns. Finally, Comprehensive attacked the surveyor's competency, questioning her knowledge of specific program requirements while characterizing her as confused and unprofessional. Id. at 17-20.
Comprehensive's arguments have no merit. The initiation of home health care following a hospital stay was itself a "change" of circumstances for this patient and required the HHA to coordinate with the patient's reviewing physician and, as necessary, to alter the patient's plan of care to ensure that it reflected the physician's current prescriptions for this patient's medicines and treatments in home health care. As the ALJ found, the home health referral form from the hospital contained the physician's order that Patient No. 6 should be on "continuous oxygen," but failed to indicate the oxygen concentration or the mode of delivery. Thus, it was incumbent on Comprehensive to contact the physician to verify key elements of the oxygen therapy that would have to be included in the patient's plan of care. Comprehensive was obligated to coordinate with the physician under 42 C.F.R. § 484.18(b) because any existing plan of care (without the concentration or the mode of delivery) was inadequate for treating the patient's condition during home health care. The evidence unequivocally demonstrates, however, that from the day this patient first entered home health care on June 10 until June 17, 1999, Comprehensive's nurse had simply set up this patient's oxygen treatment at the pre-existing setting on the durable medical equipment in the home without first verifying with the doctor that this was the correct setting. A report prepared by Comprehensive in the record referencing the first day of home health care states that this nurse explained to the patient and the family the "plans and goals of care" and "reviewed all medicines, including . . . O2 W/40% TRACH. MIST." P. Ex. 10 at 9. This evidence demonstrates that the nurse advised the patient and family about what the nurse assumed was the physician's prescribed oxygen treatment with the oxygen concentration set at 40% and the mode of delivery as TRACH. MIST, even though the nurse had failed at that time to confirm with the physician what the oxygen concentration and mode of delivery should be. Thus, in a fax dated June 17, 1999, from Comprehensive's owner to Patient No. 6's physician, Comprehensive "admitted" that one of its nurses had neglected to confirm the appropriate oxygen regimen until June 17th. Comprehensive apologized and accepted "responsibility" for this "omission." P. Ex. 10 at 3. Citing this admission and the surveyor's testimony recounting the dangers of improper oxygen administration, the ALJ determined that Comprehensive should have alerted the physician and clarified the physician's instructions in the plan of care in order to prevent "potentially serious harm" to Patient No. 6. (4) ALJ Decision at 12.
Although Comprehensive alleged that it was prevented from contacting Patient No. 6's physician because she was on vacation, the June 17th fax makes no mention of this possibility. Moreover, Comprehensive cited no evidence to corroborate its allegation that the doctor was on vacation, nor did it explain whether it attempted to contact a backup physician. Furthermore, while the patient's son as care giver actually administered the oxygen throughout the day, it was Comprehensive's responsibility to coordinate with the physician and make sure that the plan of care reflected the proper treatment for this patient so that the patient's son (and Comprehensive) knew what treatment the doctor had ordered and could make sure that the patient received the correct treatment.
In response to Comprehensive's arguments concerning the surveyor's unprofessional attitude and knowledge of program requirements, the ALJ stated that "what is relevant is whether or not CMS presented legally sufficient, reliable, and credible evidence of deficiencies based on the applicable regulations." ALJ Decision at 9. Similarly, this Board has frequently pointed out that "the appeals process is not intended to review the conduct of the survey but rather to evaluate the evidence of compliance regardless of the procedures by which the evidence was collected." Beechwood Sanitarium, DAB No. 1906 at 44 (2004). Consequently, the arguments concerning the surveyor's alleged attitude and knowledge of program requirements are unavailing.
Comprehensive's arguments do not show that the ALJ's analysis of the applicable law was erroneous nor do they demonstrate that the ALJ's factual findings were not supported by substantial evidence on the record as a whole. Accordingly, we sustain the ALJ's finding that Comprehensive failed to comply with 42 C.F.R. § 484.18(b) with respect to Patient No. 6 and Patient No. 8.
As we stated previously, CMS may terminate a HHA's participation in the Medicare program when it determines that the provider is not complying with one or more Medicare conditions of participation. Section 1866(b)(2)(A) of the Act; see 42 C.F.R. §§ 488.20, 488.24 and 488.26 and 489.53(a)(1) and (3). Section 488.24(b) provides that failure to comply with a condition of participation occurs where deficiencies are "of such character as to substantially limit the provider's . . . capacity to furnish adequate care or . . . adversely affect the health and safety of patients . . . ." The ALJ concluded that Comprehensive's deficiencies pertaining to 42 C.F.R. § 484.18(b) with respect to Patients Nos. 8 and 6 were a failure to comply with a "condition of participation" and that the deficiencies had been established by CMS at the immediate jeopardy level since they "presented situations which were likely to cause serious injury, harm, impairment, or death." After fully reviewing the deficiencies discussed in Section I above, we agree with these conclusions and therefore agree that CMS was authorized to terminate Comprehensive's participation in the Medicare program. (5)
Based on the preceding analysis, we sustain the ALJ Decision imposing the termination remedy and, in doing so, affirm and adopt the FFCLs made by the ALJ.
Judith A. Ballard
Cecilia Sparks Ford
Donald F. Garrett
1. During the course of the proceedings before him, the ALJ explained to Comprehensive's Administrator the complexities that arise in these cases and the benefits of having an attorney.
2. The Health Care Financing Administration (HCFA) is the former name of CMS. See 66 Fed. Reg. 35,437 (July 5, 2001). We use the old acronym in this decision to retain the ALJ's denomination of CMS Exhibits. Additionally, we follow the ALJ in citing Comprehensive exhibits as "P. Ex."
3. The ALJ noted, without dispute, that the normal range for blood glucose is about 60 mg./dl. to 120 mg/dl., depending on when a person last ate. See ALJ Decision at 10, n.3.
4. Although CMS also relied upon two other examples in the statement of deficiencies pertaining to the same plan of care regulation for this patient (her dietary requirements (i.e., pureed food) and her methicillin resistant Staphylococcus aureus (MRSA) protocol), it is unnecessary for us to consider them here since the deficiency relative to the administration of oxygen is clearly the most serious deficiency for Patient No. 6.
5. Having concluded that the termination is authorized based on the violation of a condition of participation at the immediate jeopardy level, it is unnecessary for us to consider whether it would also be justified on the basis of the various non-immediate jeopardy deficiencies admitted or conceded by Comprehensive.