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Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division |
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John J. Kane Regional Center - Glen Hazel, |
DATE: January 23, 2006 |
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Centers for Medicare & Medicaid Services.
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Docket No.C-02-682
Decision No. CR1394 |
| DECISION | |
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DECISION
For the reasons stated below, I conclude that John J. Kane Regional Center - Glen Hazel (Petitioner or Facility) was not in substantial compliance with federal requirements of participation governing nursing home facilities from March 19, 2002 to June 4, 2002. Accordingly, I sustain the Centers for Medicare and Medicaid Services' (CMS's) imposition of a per day civil money penalty (CMP). I, however, authorize a CMP of only $700 per day rather than the $1,500 per day as assessed by CMS. I. Background
Petitioner is a skilled nursing facility located in Pittsburgh, Pennsylvania. The Pennsylvania Department of Health (State Agency) conducted a complaint investigation survey ending on March 19, 2002, and as a result, determined that Petitioner was not in substantial compliance with Medicare and Medicaid participation requirements. On April, 25, 2002, CMS notified Petitioner of its findings contained in the Statement of Deficiencies (SOD or 2567) previously sent to Petitioner. CMS Exhibits (Exs.) 1, 3. All but one of CMS's alleged deficiencies, including one at the "G" level of scope and severity (Tag F309), were based on one incident and one resident. Id. CMS imposed a $1,500 per day CMP effective March 19, 2002. CMS Ex. 1. CMS conducted a revisit survey on June 5, 2002, and found Petitioner back in compliance as of June 4, 2002. CMS Ex. 2. Petitioner timely requested a hearing by letter dated June 19, 2002. A hearing was held before me on December 14-16, 2003, in Pittsburgh, Pennsylvania. The hearing was continued for rebuttal testimony. On March 10, 2004, further testimony was taken via telephone. (1) The record was closed on April 11, 2005, after post-hearing submissions. CMS submitted its exhibits, identified as CMS Exs. 1-20, and I admitted them into the record. Petitioner submitted its exhibits, identified as P. Exs. 1-24, and I admitted them into the record. The following persons testified for CMS: Sara Jane Flasher, State agency surveyor; Margaret H. Kosherzenko, CMS Nurse consultant; Steven A. Levenson, M.D.; Dale Van Wieren, CMS Survey and Certification Specialist; and Marguerite Pierce, advanced cardiac life support instructor. The following persons testified for Petitioner: Roberta A. Alston, a nurse formerly employed at Petitioner's facility; Carolyn Pilewski, Petitioner's Administrator; Herbert Bazron, Jr., M.D.; Cyril H. Wecht, M.D. and coroner of Allegheny County; James Love, a certified nurses aide (CNA) employed by Petitioner; Mary McNamee, the Director of Nursing at Petitioner's facility; and Peter Klimek, a respiratory therapist who formerly provided respiratory services for Petitioner. Based on the testimony offered at the hearing, the documentary evidence, the arguments of the parties, and the applicable law and regulations, I find, as explained below, that from March 19, 2002 to June 4, 2002, Petitioner was not in substantial compliance with Medicare participation requirements. I also find that a $1,500 per day CMP is not reasonable.
Petitioner is considered a long-term care facility under the Social Security Act (Act) and regulations promulgated by the Secretary of Health and Human Services (Secretary). The statutory and regulatory requirements for participation by a long-term care facility are found at sections 1819 and 1919 of the Act and at 42 C.F.R. Part 483. Sections 1819 and 1919 of the Act invest the Secretary with authority to impose CMPs against a long-term care facility for failure to comply substantially with federal 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. The regulations at 42 C.F.R. Part 488 provide that facilities participating in Medicare may be surveyed on behalf of CMS by state survey agencies in order to ascertain whether the facilities are complying with federal 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 per instance or per day CMP against a long-term care facility when a state survey agency determines that the facility is not complying substantially with federal participation requirements. 42 C.F.R. �� 488.406, 488.408, 488.430. The regulations specify that a per day CMP that is imposed against a facility will fall into one of two broad ranges of penalties. 42 C.F.R. �� 488.408, 488.438. The upper range of CMPs, of from $3,050 per day to $10,000 per day, is reserved for deficiencies that constitute immediate jeopardy to a facility's residents, and in some circumstances, for repeated deficiencies. 42 C.F.R. �� 488.438(a)(1), (d)(2). The lower range of CMPs, of from $50 per day to $3,000 per day, is reserved for deficiencies that do not constitute immediate jeopardy, but either cause actual harm to residents, or cause no actual harm, but have the potential for causing more than minimal harm. 42 C.F.R. � 488.438(a)(2). The regulations define the term "substantial compliance" to mean "a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm." 42 C.F.R. � 488.301. When a penalty is imposed and appealed, CMS must make a prima facie case that the facility has failed to comply substantially with federal participation requirements. To prevail, a long-term care facility must overcome CMS's showing by a preponderance of the evidence. Hillman Rehabilitation Center, DAB No. 1611 (1997); aff'd, Hillman Rehabilitation Center v. United States Department of Health and Human Services, No. 98-3789 (GEB), slip op. at 25 (D.N.J. May 13, 1999). Under Hillman, CMS bears the burden of coming forward with evidence sufficient to establish a prima facie case that Petitioner failed to comply with participation requirements. Once CMS has established a prima facie case of noncompliance, Petitioner has the burden of proving, by a preponderance of the evidence, that it complied substantially with participation requirements. Hillman, at 3-8. (2) The Act and regulations make a hearing before an Administrative Law Judge (ALJ) available to a long-term facility against whom CMS has determined to impose a CMP. Act, sections 1128A(c)(2); 42 C.F.R. �� 488.408(g), 498.3(b)(12), (13). The hearing before an ALJ is a de novo proceeding. Anesthesiologists Affiliated, et al, DAB CR65 (1990), aff'd, 941 F2d. 678 (8th Cir. 1991). II. Issues The issues in this case are: whether CMS has a factual basis to impose remedies against Petitioner for failing to comply substantially with federal requirements and, if so, whether the amount of CMS's imposed CMP is reasonable. III. 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 of my ultimate Findings below as a separate heading. I discuss each Finding in detail, including the results of the survey, whether the results are supported by the evidence of record, and whether Petitioner has met its burden to overcome the findings the surveyors made.
The regulations at 42 C.F.R. � 483.25, require that each resident at a nursing facility must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.
CMS's alleged deficiency regarding this tag centers upon an incident involving one of Petitioner's former residents who will be referred to in this decision as R1. R1 was 84 years old. He had hardening of the arteries, an enlarged heart, lung congestion, past prostate cancer, hypertension, a pacemaker and a PEG tube for feeding. Tr. 563-64. R1 had chronic osteomyelitis from a foot infection and had recently begun IV antibiotic treatment. R1 also had a diagnosis of dementia. Tr. 187, 520, 555, 564, 840; P. Ex. 13. Although at times R1 was alert and oriented to name and was responsive to verbal and tactile stimuli, he was considered to be "severely impaired" in cognitive skills. CMS Ex. 16, at 7, 9. R1 did not have a DNR (do not resuscitate) order written by his physician. Tr. 37. R1 was unable to participate in a discussion with his physician regarding a DNR order. R1's daughter did not want her father to be DNR. Tr. 95, 550. Further, R1 had no medical order or advanced directive stating that cardiopulmonary resuscitation (CPR) was not to be used on him. In a nursing home, the absence of a DNR order for a resident having a recent and/or witnessed cardiopulmonary arrest generally requires that emergency services (911) be called and CPR initiated. Tr. 37, 453, 904-05, 42a-43a. On the morning of March 13, 2002, R1 was moved to the Facility's nurses' station at around 6:30 a.m. He had a breathing treatment at 8:00 a.m. Tr. at 284. After another period of time at the nurses' station, R1 went to therapeutic recreation at about 10:00 a.m. Tr. at 275, 286. Prior to 11:30 a.m. and lunch, R1 was moved back to the nurses' station. Tr. at 39, 275-76, 287. A short time later, R1 had noisy breathing, a condition called stridor (Tr. at 205), indicating a possible obstruction in the windpipe. Tr. at 39, 275-76. Nurse Alston took R1's pulse and respirations. Nurse Alston then told R1 that she thought he was having lots of problems and needed to go to the hospital. R1 shook his head no. Tr. at 293. Another of the Facility's nurses, Bernadette Sens, arrived with an antibiotic IV that she intended to administer to R1. P. Ex. 13, at 3. A respiratory therapist exited a nearby elevator at this time. Tr. at 39, 877. He and several other staff members quickly moved R1 to his room. Tr. at 39, 291. Nurse Alston left to call R1's daughter. Nurse Alston did not call 911. (3) Tr. at 277, 299. R1's daughter wanted R1 given CPR and/or transferred to a hospital. Tr. at 280, 304. Nurse Sens did not call 911 either. Tr. at 298, 633. (4) In the meantime, the respiratory therapist and two nurse supervisors attempted to assist R1. Respiratory therapist Klimek testified about what occurred in the most detail. He described R1's room as having an outer area for gowning. R1 had isolation requirements due to his osteomyelitis. Tr. at 877. Someone on the staff retrieved the emergency suction set up and attempted to suction R1's throat. Id. at 878. R1 was looking gray and was working harder to breathe. Id. R1 seemed to be awake and held out his finger for a pulse oximeter reading. Tr. at 879. The staff present on the scene had a difficult time suctioning R1 but finally removed a moderate amount of thick blood-tinged mucus from deep in R1's throat and a granuloma -like piece of tissue from his tongue. Tr. at 41, 878; CMS Ex. 16, at 10. Yet, R1's breathing did not improve. Shortly thereafter, R1 stopped breathing and the staff could not find R1's carotid pulse. Tr. at 880. Therapist Klimek listened by stethoscope to R1's heart and felt no air movement or chest rise and R1's eyes had a vacant look. Tr. at 881. R1 had been responsive but within five to seven minutes, he had no heartbeat or respiration. Id. The staff then used a bag mask to ventilate R1 and moved him back to his bed, put a bed board underneath him and initiated CPR. Tr. at 880, 885; CMS Ex. 3, at 5. Someone on the staff decided to cease CPR after two to three sequences. Tr. at 569, 885, 901-03. One of Petitioner's nurses, although there is no clear evidence as to which one, pronounced R1 dead at 12:00 pm. Tr. at 40. (5) Petitioner's policy on CPR is quoted below.
As long term care facilities the Kane Regional Centers' mission is not to provide acute resuscitative intervention in the event of cardiopulmonary arrest, as is generally available in an acute general hospital, but rather to have available in unexpected situations the following measures as seen warranted by professional judgment: (Emphasis added)
CMS Ex. 6, at 1. Petitioner had additional policies relating to treatment and transfer of residents experiencing unexpected cardiac or pulmonary arrest. The first person on the scene was to initiate CPR and call for assistance. The second person on the scene was to notify the operator of the situation and to relieve or assist the first person doing CPR. The operator was to call the certified ambulance service for that Regional Center, call the nursing supervisor and page the in-house physician. The nursing supervisor was to give assistance if needed and notify the family. Id. at 2.
In the SOD, CMS charges that Petitioner's staff failed to follow the facility policy for cardiopulmonary resuscitation, and failed to initiate a hospital transfer or obtain emergency medical treatment for R1. CMS Ex. 3, at 4. Therefore, according to CMS, Petitioner failed to provide R1 the necessary care and services to attain or maintain his highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care as required by 42 C.F.R. � 483.25. Petitioner makes the following arguments in response.
Petitioner argues that R1's cardiopulmonary arrest was "expected" and, thus, its policy relieved it of the obligation to provide CPR to R1. R1's physician testified that R1 had multiple organs near failure and his death was expected. Tr. at 507, 521-22, 524, 570. I find the words "expected" and "unexpected" in Petitioner's policy cannot be interpreted as stated by R1's physician. R1's death was more expected than others around him because of his age and condition but it was not expected to be at any particular time in the near future. Tr. at 231-32, 234. The only logical interpretation of Petitioner's policy is that its reference to an "unexpected" arrest refers to an arrest that is sudden and/or is witnessed. Otherwise, if cardiac arrest is actually expected for a resident, the staff should be exceptionally attentive to that particular resident for the period of expectation. If cardiac arrest is "expected," something should be done for a resident that does not have advance directives prohibiting aggressive life-saving measures. Logically, the words "unexpected" and "expected" in Petitioner's policy can have nothing to do with the general health of the victim. Otherwise Petitioner need provide no CPR because the majority of its residents are at higher risk of cardiopulmonary arrest. Moreover, if Petitioner's policy would be interpreted as Petitioner argues, someone on Petitioner's staff would have to make the decision whether a resident's arrest was expected. One wonders what criteria would be used to make such a decision. Further, although R1 was seriously ill, he had been in his normal state of health at the time of the arrest. Tr. at 174, 204-05, 35a. He had gone to both his respiratory treatment and therapeutic recreation earlier in the morning without any noted change in his condition. Tr. at 231-32, 234. Rather than using an "unexpected" arrest as a determinant of providing CPR, one common criteria to determine whether CPR should be performed is whether a victim's arrest is witnessed or unwitnessed. It is far more likely, both intuitively and according to experts, that a victim can be revived if the arrest is witnessed. Tr. at 212-13, 229-31. This is because it is clear to the CPR provider that the victim has not been dead for some time. R1's arrest in this case was certainly witnessed. Tr. at 229, 231.
The accepted standard is that when a person does not have a DNR order, CPR is done. (6) Tr. at 172, 207-10, 242. Further, if CPR is going to be done, the first step in the process is to call 911 so that additional emergency services can arrive as quickly as possible. Tr. at 213, 216, 228-29, 453. No one on Petitioner's staff called 911 when R1 arrested. Petitioner's Administrator, Carolyn Pilewski, testified that had the staff called "911," the emergency team would not have arrived at the facility for ten to fifteen minutes. Tr. at 504-506. Administrator Pilewski further testified that the emergency team in the area of Petitioner's facility complains about being called to pick up dead people. Id. That the emergency team complains does not answer the question as to why it was not called. The uncooperative nature of the emergency team does not absolve Petitioner of its responsibilities.
"Professional judgment" is not an appropriate measure of whether CPR should be initiated or continued unless a process is followed. If the phrase "professional judgment" is contained in a facility's policy, the policy must be fully explained to the residents and their families before admission to the facility. CMS presented an expert witness, Steven A. Levenson, M.D., who has extensive experience in the long-term care field and with federal regulations. He testified credibly and persuasively about the ethics of when CPR should be initiated and how long it should last. Tr. at 204, 218-19. Dr. Levenson opined that using professional judgment in these situations is legitimate if the professional follows a process and as the professional goes through the process, he or she makes decisions based on the evidence at each step of the process. Id. According to Dr. Levenson, it was not appropriate for Petitioner to fail to call 911 nor to cease CPR once started, based on an amorphous reason such as professional judgment. Tr. at 50a-51a, 53a. As shown by the testimony of Petitioner's staff and Petitioner's expert witness, Dr. Cyril Wecht, end-of-life issues and what treatment to provide are viewed quite differently to different people. Deciding which view should be followed is not easy. (7) In terms of making such difficult ethical decisions in nursing home settings, I found the procedures preferred by Dr. Levenson, who has written and studied in this area of medical ethics, to be far more persuasive. The philosophy is simply that, if the ethics of a decision are difficult, standard procedures must be followed. To the extent that Petitioner's policy regarding resuscitation allowed the staff to use its "professional judgment" to make decisions in the moment without following a process in making the decision, the policy does not accord with ethical standards. Tr. at 235-37. The "professional judgment" exception in Petitioner's policy reads like "fine print." Those residents and their families who were shown Petitioner's policy should have been able to assume that, as stated in the first paragraph of the policy, if the resident had no DNR order, CPR would be provided and it would be provided as set forth in generally accepted guidelines. Moreover, Petitioner provided no evidence that its CPR policy with the "professional judgment" exception was explained to prospective residents and their families. Tr. at 210, 243-44, 248. Petitioner can argue that it followed the "fine print" of its CPR policy but Petitioner did not follow the essence of its policy. The American Heart Association guidelines set out a systematic approach to performing CPR that is a nationally recognized standard. Tr. at 215. The accepted standard for doing CPR requires that CPR continue until one of the following occurs: emergency services arrive; a physician orders CPR to cease; the person being resuscitated begins to have breath and pulse; the CPR provider is too exhausted to continue; or the CPR provider is in immediate harm. Tr. at 43. The CPR of only two to three sequences that was afforded R1 was inadequate. Tr. at 211, 451, 454.
In this case, Petitioner's witnesses pointed to certain aspects of R1's presentation that suggested to them that further CPR would be useless. For example, R1 was flaccid when the staff moved him to his bed. Tr. at 883. Further, R1's skin became mottled and his pupils were dilated. Dr. Levenson testified, however, that mottling of the skin simply refers to patchy or streaky discoloration of the skin, and that mottling can occur in living persons. Mottling of the skin does not mean that a person is irreversibly dead. Tr. at 222. Similarly, dilated pupils is a physical sign or finding but does not indicate that a person is irreversibly dead. Tr. at 162-63, 222-24. Petitioner inappropriately relied on R1's mottling of skin and dilated pupils to stop CPR. Id. In this case, I need not get into the conundrum of whether CPR is actually for the dead or the living. See CMS Reply Brief (R. Br.) at 9. Certainly each potential CPR recipient has signs of death. The victim is in the death process. That is why CPR is initiated and why following recognized and accepted procedures is so important. Tr. at 226-28. In a situation of a witnessed cardiopulmonary arrest, an observer, even a trained healthcare provider, may not be able to determine immediately that irreversible death has occurred. That is why following a process and generally accepted procedures is crucial. Id.
CMS is exaggerating when it says that R1 wanted CPR. CMS R. Br. at 3. His wishes in that regard are unknown. He had no DNR order. Had advance directives been discussed with R1 prior to his cognitive state at the time of his arrest, R1 may or may not have approved CPR. Tr. 207-08. Nonetheless, with a resident who has no DNR order, a facility should treat the situation as if the resident affirmatively wants CPR. Tr. 235-37. A nursing home resident can refuse treatment. Tr. at 843; 42 C.F.R. � 438.10(b)(4). Petitioner argues that R1 specifically expressed his wishes about whether 911 should be called when he shook his head in a manner suggesting "no." Petitioner, in fact, presented no evidence that R1 was actually asked if he wanted to go to the hospital, or wanted CPR, or wanted the staff to call 911. Rather, Petitioner presented evidence that, although R1 was impaired cognitively, and could not engage in a dialogue with his physician about resuscitation and advanced directives, Nurse Alston, having been with R1 on a more regular basis, could suggest to him in the middle of R1's respiratory distress that he might have to go to the hospital, and could reasonably accept R1's shaking of the head as expressing R1's will about his future care. Tr. at 300-01, 499, 692. Petitioner is unpersuasively stretching an offhand comment and non-specific response into a discussion about R1's medical wishes. Dr. Bazron, R1's personal physician, testified that R1 was able to answer simple direct questions without a lot of integration of information. Tr. at 537. Nonetheless, as Dr. Levenson testified, during R1's breathing difficulty was simply an inappropriate time to discuss the issue of going to the hospital with R1. Tr. at 242, 263-64, 31a, 40a. It is questionable whether R1 could have even expressed his desires about this issue under non-stressful conditions given his cognitive limitations.
Petitioner presented an expert witness, Dr. Cyril H. Wecht, M.D., J.D. Dr. Wecht presented his philosophical opinion about the hopeless extension of human life. In his view, common CPR standards are not applicable for an 84 year-old person who has known significant heart disease. Tr. at 585, 592. Dr. Wecht testified that:
Tr. at 586. Dr. Wecht made valid points, all of which should have been brought up with R1's family prior to the incident at issue. See Tr. at 39a-41a. Indeed, Dr. Bazron, R1's physician, may have discussed these issues with R1's daughter. According to Dr. Bazron, ". . . his daughter was a major player for him in all of these discussions. Basically, she made sure that we were aggressive on every occasion." Tr. at 550. Because R1 was incapable of making an informed decision on this issue, either his daughter's view should have prevailed and/or R1 should have been treated as any other resident without a DNR order. (8) At this point, the Facility was required to follow the process for its residents without DNR orders and go through the steps as desired by R1's family, regardless of the very low probability for reviving R1. Tr. at 207-08, 462. No one denies that resuscitation and survival rates as a result of CPR are very low for the normal nursing home population. Tr. at 227. According to Dr. Levenson, however, age and general health are not the only predictors for survival after CPR, and decisions regarding continuation of CPR should not be based on criteria of age and general health. Tr. at 462-63, 24a-27a. Indeed, about a year previously, R1 had survived after an arrest and the application of acute life saving measures. Tr. at 217, 236; P. Ex. 13, at 2. Without a process, which generally accepted CPR guidelines provide, decisions regarding life sustaining measures would be left to the staff's judgment about each particular resident's potential for survival. Tr. at 219-20. This could be a frightening situation for the residents and the facility's staff. Advanced directives and DNR orders provide a process and absolve a facility's staff from making unenviable decisions about what life-saving measure should be used. Generally accepted standards for CPR provide a process as well. The residents and their families should have been able to assume that CPR would be done as it is generally taught, according to accepted standards, whether or not those standards were explicitly stated or referred to in the facility's policy.
Petitioner argues that its policy on CPR was not the same as the American Heart Association's procedures. According to Petitioner, its policy was not based on those procedures. Whether or not Petitioner's policy incorporated American Heart Association CPR guidelines is not the issue before me. An analysis of Petitioner's compliance with Tag F309 depends, in part, on whether the facility has followed generally accepted practices. An appellate panel of the Departmental Appeals Board (DAB) has found that not providing necessary care and services can depend on more than a facility's policy. Meeting professional standards of quality defines the minimum services that must be provided. Spring Meadows Health Care Center, DAB No. 1966 (2005). The American Heart Association CPR guidelines are accepted as the professional standard of quality. Tr. at 164, 215.
Even though the probability of saving R1 by calling 911 and doing CPR was low, R1 had no chance of survival without such action. He, thus, suffered actual harm as a result of Petitioner's failure to provide R1 with the necessary care and services for R1 to maintain his highest practicable physical, mental or psychosocial well-being in accordance with his comprehensive assessment and plan of care. Tr. at 261, 268-69, 46a - 47a.
I will not set forth a detailed analysis of CMS's other alleged deficiencies. Petitioner's failure to comply substantially with one Medicare participation requirement is sufficient for finding a basis for CMS's imposed penalties. Beechwood Sanitarium, DAB No. 1824 (2002). Moreover, an ALJ need not discuss every alleged deficiency in a decision. Western Care Management Corp., d/b/a/ Rehab Specialties Inc., DAB No. 1921 (2004). I will make, nonetheless, several comments about Tag F282, a deficiency under 42 C.F.R. � 483.20 (k)(3)(ii). This regulation requires that the services provided or arranged by a facility must be provided by qualified persons in accordance with each resident's written plan of care. CMS charged that Petitioner failed to consistently ensure timely re-certification for 22 of 174 nursing staff to ensure that the staff was qualified to perform cardiopulmonary resuscitation. CMS Ex. 3, at 1. CMS presented evidence that many of Petitioner's staff members' CPR certifications had expired and that Petitioner could not provide copies of all of the nurses' CPR certifications. Tr. at 55. CMS provided testimony that nursing standards require a facility to have a list of personnel who are certified in CPR. Tr. at 55. Petitioner's policy, however, was to require CPR certification when a nurse was first employed and to provide required annual in-service training on CPR and information on re-certification. Tr. at 490, 496, 825. Even though CPR certification for facility nurses is not specifically required by the regulations or Petitioner's policy, it is hard to imagine how Petitioner could ensure that CPR services could be performed by qualified persons if re-certification was not required for some staff members and if Petitioner was unaware of which staff members were so qualified. I find, therefore, that Petitioner failed to rebut CMS's prima facie case regarding Tag F282.
CMS may impose a CMP "for the number of days a facility is not in substantial compliance with one or more participation requirements. . . ." 42 C.F.R. � 488.430(a). When an ALJ finds that the basis for imposing a CMP exists, the ALJ may not: (1) set a penalty of zero or reduce the penalty to zero; (2) review the exercise of discretion by CMS to impose a CMP; and (3) consider any factors in reviewing the amount of the penalty other than those specified in section 488.438(f). I have found that a basis exists for CMS to impose a CMP because I have found that Petitioner was not in compliance with 42 C.F.R. � 483.25. I must, therefore, review de novo whether the amount of the CMP is reasonable by considering the four factors specified in 42 C.F.R. � 488.438(f). These four factors are: (1) the facility's history of noncompliance, including repeated deficiencies; (2) the facility's financial condition; (3) the scope and severity of the deficiencies, the relationship of one deficiency to other deficiencies, a history of noncompliance with reference to the deficiency at issue (factors specified in 42 C.F.R. � 488.404); and (4) the facility's degree of culpability. Given the constrictions in the regulations, I cannot consider specifically, as urged by Petitioner, whether CMS's imposed penalty is arbitrary or capricious. Petitioner's (P.) R.Br. at 7. The record contains no evidence that Petitioner has a bad compliance record. Further, CMS presented no evidence that Petitioner had previously been found noncompliant with 42 C.F.R. � 483.25. The evidence of Petitioner's financial condition that CMS reviewed did not indicate that Petitioner was having financial difficulties. Tr. at 416. It had not filed for bankruptcy or asked for advance payments from Medicare. On the other hand, Petitioner submitted evidence at the hearing that it had suffered a substantial loss in the preceding year. P. Ex. 24. Petitioner did not submit a corresponding balance statement, however. And one of the reports submitted by Petitioner (P. Ex. 24, at 6) suggests that Petitioner has a large "fund balance." Petitioner provided no explanation of the financial information it submitted. I find that Petitioner can pay the CMP imposed by CMS but payment may affect other needed services. A smaller CMP will still provide a significant incentive for compliance. The scope of Petitioner's noncompliance was limited to one resident even though the likelihood that similar failures could happen was relatively high given Petitioner's ambiguous CPR policy. (10) In addition, R1 suffered actual harm as a result of Petitioner's noncompliance. The severity of Petitioner's compliance was rated by CMS as "G," serious, but not immediate jeopardy. As noted previously, R1's survival probability was low, but with Petitioner's noncompliance the probability was zero. I do not find the culpability of Petitioner's staff to be as high as does CMS. See Tr. at 414. I did not find Petitioner's staff members to have shown neglect or disregard for R1's care, comfort or safety. I do find the staff members to have been indifferent to the meaning of a non-DNR status, too concerned about the complaints of the local emergency services, and more inured (indifferent) to the fact of an old and frail resident dying. 42 C.F.R. � 488.438(f)(4). Certainly the severity of the noncompliance indicates that a per day CMP of more than $50 is warranted. I note, however, that, as pointed out by Petitioner, CMS, when changing the CMP from the recommended $1,500 per instance to $1,500 per day may have been under the impression that R1 arrested because he had something in his throat, such as food, although he required tube feeding. Moreover, Petitioner's past compliance, financial condition, a lesser culpability than CMS assigned, and the limited scope of the noncompliance suggest a CMP substantially less than the $3,000 upper penalty range. Given the remedial purpose of a CMP, I find that $1,500 per day is unreasonable. My review of the factors set forth in 42 C.F.R. � 488.438(f) persuades me that a $700 per day CMP is reasonable and certainly high enough to encourage compliance. The CMP that CMS imposed became effective on March 19, 2002, and was discontinued effective June 4, 2002. Early on in these proceedings and in its post-hearing brief, Petitioner argued that the length of the CMP was inappropriate because the Tag F309 violation was a one-time event. P. Br. at 13-14. Neither at the hearing nor in post hearing briefing did Petitioner refer to evidence that the duration of the assessed CMP was incorrect; for example, by showing that it had achieved compliance by training staff earlier than June 4, 2002. I, therefore, determine that Petitioner returned to compliance on the date determined by CMS, i.e., June 4, 2002. The Petitioner's CMP will total $54,600. IV. Conclusion Due to Petitioner's substantial noncompliance with the requirements of Medicare and Medicaid participation, I conclude that CMS is authorized to impose a per day CMP of $700 for the period of March 19, 2002 to June 4, 2002. |
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| JUDGE | |
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Anne E. Blair Administrative Law Judge |
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1. References to transcript pages for the rebuttal testimony are identified with a small letter "a" suffix following the identified transcript page number . 2. The burden of persuasion set forth in Hillman applies only where the evidence proffered by both sides is "in equipoise." In such cases, the burden of persuasion would be on the Petitioner. 3. Petitioner suggests that R1 was not yet in such a dire straight that 911 should have been called at that time. Tr. at 322, 812-13. Yet, this contradicts Nurse Alston's other testimony that she thought immediately that R1 was dying. Tr. at 279. 4. Although Nurse Sens was on Petitioner's witness list, and a subpoena was requested and issued for her appearance, Nurse Sens did not testify. Petitioner states Nurse Sens could not be located. CMS asks that I make an adverse inference from Nurse Sen's failure to testify. CMS Br. at 3, n.5; 34. I see no need to make such an inference. The record evidence satisfies me that Petitioner was not substantially compliant with 42 C.F.R. � 483.25. 5. The initially listed cause of death was respiratory failure. Tr. 239. A question remained whether R1 had a respiratory obstruction from the possible inappropriate ingestion of food. A later death certificate indicated that R1's death was due to chronic conditions. Tr. 239-40. 6. It is unclear at what point in the process Petitioner determined that R1 was a "full code," meaning he did not have a DNR order. When Nurse Alston left to phone R1's daughter, the daughter apparently told Nurse Alston she wanted her father to have CPR. P. Ex. 13, at 4. Nurse Alston returned to the room with R1' s chart that showed he was a "full code." P. Ex. 19, at 1. 7. I am aware that it is not my obligation to set forth the ethical choice in these situations. For this decision, I focused on whether Petitioner had provided necessary care and services as required by 42 C.F.R. � 483.25. Whether a service is necessary may or may not be related to ethics, but is certainly related to the accepted standards of care. See Finding 10, below. 8. There is no record evidence that R1's daughter actually had a signed power of attorney. Tr. at 502. Nonetheless, the daughter was involved in his care. R1's physician knew she wanted aggressive measures taken for her father. Tr. at 520, 550. More importantly, R1 had no signed DNR order at the Facility. 9. CMS claims that Petitioner in its request for hearing had not appealed any tag other than Tag F309. In fact, Petitioner appealed, in its request for hearing, all determinations contained in the SOD. See Petitioner's June 19, 2002 letter requesting a hearing. During a prehearing telephone conference on November 21, 2003, however, the parties limited the issues for hearing to two tags, F309 and F282. 10. According to CMS, a systemic problem can exist if a facility's staff cannot readily identify who has no DNR order. Tr. at 413. CMS presented no evidence that Petitioner could not identify its "full code" residents. | |