The Issue Whether Petitioner, Agency for Health Care Administration (AHCA or Petitioner), is entitled to a recoupment for a Medicaid overpayment to Respondent, Humane Minority, Inc. (Humane or Respondent), in the amount of $177,581.26.
Findings Of Fact Petitioner is the state agency responsible for administering the Florida Medicaid Program. As part of its duties, Petitioner attempts to recover Medicaid overpayments from Medicaid providers. At all times material to this case, Humane was licensed to provide various health care services to Medicaid recipients under a contract to AHCA as a Medicaid provider. As provider number 255724000, Humane participated in the Medicaid program from January 1, 2005, to February 8, 2006 (audit period). As a Medicaid provider, Respondent was subject to audit. This case arose when the Discovery Unit of Medicaid Program Integrity (MPI) identified that during the audit period Humane billed 1.5 times as much for one week as compared to ten other weeks, which is an indicator of billing irregularities. As a result, the Discovery Unit of MPI recommended a comprehensive audit of Humane. Gary Mosier, a Registered Nursing Consultant employed by AHCA in the bureau of MPI, initiated the audit of Humane after receiving the Discovery Unit’s File #47650 Recommendation memo dated May 19, 2006, referring Humane for a comprehensive audit. On or about June 13, 2006, MPI requested 30 random Medicaid patients' records from Humane’s entire Medicaid patient group for the audit period. Humane complied with the request and supplied records. The submitted medical records included a Certificate of Completeness of Records from Humane stating the documents supplied constituted all of the Medicaid-related records for the 30 patients during the Audit period. After Humane provided the requested medical records to Mosier, he forwarded the records to three physician consultants: Machado, a general practitioner; Edgar, a psychiatrist; and Reisman, an urologist. Each physician consultant reviewed Humane’s records relevant to his area of expertise and filled out agency worksheets detailing why claims should be disallowed. MPI reviewed Humane’s records provided and the worksheets filled out by the three physician consultants and determined that overpayments were made to Humane due to numerous services in whole or in part not being covered by Medicaid, which violated various Medicaid policy guidelines set forth in both the Florida Medicaid Provider General Handbook (General Handbook)1 and the Florida Medicaid Physician Services Coverage and Limitations Handbook (Physician Services Handbook).2 Humane violated policy by providing documentation that supported a lower level of office visit than the one for which Humane billed and received payment. Humane violated policy by billing and receiving payments for some services that were not documented. Humane violated policy by billing and receiving payment for services rendered by a practitioner who was not a member of Humane’s group. Humane violated policy by billing for procedure codes that have time requirements but not documenting the time spent providing the service. Humane violated policy by billing and receiving payment for services performed by another practitioner who was not enrolled in Medicaid at the time the services were rendered. Humane violated policy by billing and receiving payment for services for which the medical records, when reviewed by a Medicaid physician consultant, indicated that the services provided did not meet the Medicaid criteria for medical necessity. Humane violated policy by billing for radiology services when the reading and interpretation was done by a radiologist outside of the physician’s group. Humane violated policy and was paid for billing and received payment for portable x-ray services where Humane performed only the technical component and an independent interpreter performed the professional component. Humane violated policy and received payment when Humane did not bill according to the current procedural terminology guidelines in certain instances. On March 13, 2007, MPI issued its Preliminary Audit Report (PAR). The report detailed the Medicaid policy violations, overpayment amounts, and provided Humane the opportunity to submit an explanation or additional documentation demonstrating that some or all of the claims were properly paid. The report also notified Humane that a Final Audit Report (FAR) would be issued identifying the amount of overpayment due. Humane did not respond to the PAR. Consequently, on April 27, 2007, MPI issued a FAR, that included the amount of $177,581.26 that Humane received from Medicaid that was not authorized to be paid. This grand total of $177,581.26 constitutes an overpayment that Humane must return to the agency. A Final Audit Report-Corrected Copy was issued on May 22, 2007, correcting the total amount due.3 In addition to the overpayment amount, Petitioner also seeks a fine in the amount of $3,000.00. The fine is a calculated amount as authorized by rule.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency enter a final order requiring Humane to repay the Agency for the principal amount of $177,581.26 together with an administrative fine of $3000.00. DONE AND ENTERED this 22nd day of June, 2009, in Tallahassee, Leon County, Florida. S JUNE C. McKINNEY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 22nd day of June, 2009.
The Issue Whether Respondent committed the violations alleged in the Amended Administrative Complaint and, if so, what penalty should be imposed.
Findings Of Fact AHCA is the agency responsible for the licensing and regulation of assisted living facilities in Florida pursuant to chapters 429 and 408, Part II, Florida Statutes. At all times material hereto, Kipling Manor was licensed by AHCA as an assisted living facility. Kipling Manor is located in Pensacola, Florida, and operates a 65-bed facility, license number 7285, and holds a specialty limited health license. Norma Endress is a registered nurse employed by AHCA. She conducts surveys of nursing homes and assisted living facilities for compliance. Ms. Endress is supervised by Patricia McIntire, a nurse consultant supervisor for AHCA. Ms. McIntyre has been with AHCA for 13 years. Belie Williams is the administrator of Kipling Manor. He has been involved with health care services for approximately 35 years, and has been an administrator of ALFs for approximately 15 years. He has been involved with the Florida Assisted Living Association (FALA) and served on its board. Mr. Williams helped implement training sessions for ALFs in conjunction with FALA for the past eight years. Kipling Manor has two nurses who visit the facility to provide care to the residents. Elizabeth McCormick is an advanced nurse practitioner (ARNP) in family, psychiatric and mental health. She has been a nurse since 1983 and has extensive experience dealing with inpatient and outpatient psychiatric residents in long-term facilities. Nurse McCormick works with a VA facility providing inpatient and outpatient care on a high intensity psychiatric unit. She was also an assistant professor at the University of West Florida in the Mental Health Nursing Program. Nurse McCormick provides medical and mental healthcare for residents at several ALFs in Pensacola, including Kipling Manor. She sees patients at Kipling Manor several times a month. She manages the healthcare of residents, diagnoses illnesses, and writes prescriptions as needed. She describes Kipling Manor as not being a typical setting because her patients there are seriously mentally ill, which presents huge challenges. Angela Lavigne is a registered nurse certified by Medicare to provide psychiatric care to patients. She is employed by a company called Senior Care. Among other things, she works with assisted living facilities providing therapeutic counseling, assisting doctors with adjusting medication, and providing in-service training to staff of these facilities in regard to psychiatric care. Nurse Lavigne has been seeing patients at Kipling Manor for almost three years. She visits Kipling Manor approximately four times a week. At the time of the survey, she visited the facility once or twice a week. She provides patient care as well as in-service training to the staff regarding psychiatric issues. She also runs group sessions with the residents to make them feel more independent and feel more like they are in their homes. On July 12 through 14, 2011, Nurse Endress conducted an unannounced complaint survey of Kipling Manor that gave rise to the Amended Administrative Complaint and to this proceeding. Count I--Resident 8 Count I alleges that Kipling Manor failed to provide incontinent care for Resident 8 and failed to provide nail and facial care for Resident 6. Ms. Endress observed Resident 8 walking with a "med tech" to the "med room" to receive her medications. Ms. Endress observed wetness on Resident 8's clothes, and noticed the smell of urine. The med tech gave Resident 8 her medications, then assisted her to an open area where Resident 8 sat down. Ms. Endress observed Resident 8 for about two hours. Ms. Endress approached a personal care assistant (PCA), who was a new employee, and inquired of the PCA as to whether the resident was incontinent. As a result of this inquiry, Ms. Endress believed that this resident was incontinent. After approximately two hours had passed, Ms. Endress called this to the attention of the PCA, who then changed Resident 8 immediately. Ms. Endress determined that Respondent was "not providing care for this lady, incontinent care. They were not monitoring her." This determination was based in large part on her belief that Resident 8 was incontinent. However, Resident 8's health assessment indicates that Resident 8 needed supervision while toileting, but did not carry a diagnosis of incontinence. Ms. Endress acknowledged at hearing that supervision with toileting is not the same thing as being diagnosed with incontinence. Resident 8's health assessment also reflects diagnoses of personality disorder, dementia, and Alzheimer's among other conditions. Ms. McCormick provided health care services to Resident 8. She quite frequently is involved with residents who have toileting issues. Had Resident 8 developed skin problems because of toileting issues, she would have been aware of it. Ms. McCormick noted that the records indicated that Resident 8 received a skin cream three times a day to prevent such skin problems. Both Ms. Endress and Ms. McCormick are of the opinion that, while it is better to change a resident as soon as possible, a two-hour check is appropriate for someone with toileting issues. According to Ms. McCormick, if she were looking to determine whether there existed a direct physical threat to Resident 8, there would be monitoring for skin breakdown, redness or irritation, or a possible urinary tract infection (UTI). Neither Ms. McCormick nor Ms. Lavigne were notified or saw any signs of a skin infection, other skin problems, or a UTI regarding Resident 8. There was no evidence presented that Resident had any skin problems or UTI as a result of this incident or her toileting issues. Erica Crenshaw is a "med tech" and a supervisor employed by Kipling Manor. She provided care for Resident 8 and was on duty the days of the survey in question. Ms. Crenshaw verified that Resident 8 was on a two-hour check at the time of the survey. This involved checking to see if Resident 8 was wet or dry. If she were found to be wet, staff would take off the resident's brief, change and wipe the resident, put on a new brief noting the date and time, as well as recording the staff person's initials. When changing Resident 8, staff would apply a barrier cream, and check to see if any bed sores developed. Ms. Endress determined that this was a Class II violation because of the potential for skin breakdown and infection as well as potential for emotional harm, in that she perceived this as a dignity issue for Resident 8. Ms. Endress based this opinion in large part on her mistaken belief that Resident 8 was incontinent. Her supervisor, Ms. McIntyre, reviewed the classification recommended by Ms. Endress and concurred that Class II was appropriate because "[r]esidents, in particular elderly residents, left sitting in urine, there is a great potential for them to experience skin breakdowns, which would certainly have a severe negative impact on their physical health." Mr. Williams saw Resident 8 while Ms. Endress was conducting her inspection. He saw that she was wet from urine on the back of her clothes. He did not detect any strong odor of urine although he was close to her. Count I--Resident 6 Count I also includes allegations regarding Resident Ms. Endress observed Resident 6 with long facial hair (Resident 6 is female) and long, dirty fingernails. Ms. Endress interviewed Resident 6 regarding these observations. Based upon this interview, Ms. Endress believed that staff did not cut her facial hair or trim her nails, despite Resident 6 wanting them to do so. Ms. Endress estimated Resident 6's nails to be approximately one-quarter inch long but could not recall the length of her facial hair. Resident 6's health assessment reflects a diagnosis of dementia with poor short term memory, and that she needs assistance bathing, dressing, and grooming. Erica Crenshaw described Resident 6 as "a little difficult to work with." Staff works on nails, hands and feet, two days a week. If at first Resident 6 was resistant to having her nails trimmed, they would "give her space" then approach her again later. She described Resident 6's nails as "pretty decent." Resident 6 received health care from both Ms. Lavigne and Ms. McCormick. Both nurses are of the opinion that staff worked with Resident 6 to keep her nails in good shape. As a resident of an ALF, Ms. McCormick noted that Resident 6 had the right to refuse nail care and decide whether her nails needed to be trimmed. Ms. Lavigne informed staff that they needed to work with Resident 6 at her own pace, and to be careful not to make her combative. Ms. Lavigne treated Resident 6 for a wrist problem in mid-summer of 2011, when Resident 6 was in a splint for approximately six weeks, and received physical therapy. She described Resident 6's nails as "nice, round, nothing broken, nothing chipped. Every once in a while she's actually let staff put nail polish on them but as far as cutting them down, it's like an act of Congress to get her to sit down enough to trim them." There is no evidence as to what could have been under Resident 6's nails when Ms. Endress saw her. However, the evidence establishes that Resident 6's nails were tended to by staff on a regular basis, and that her treating nurse was not aware of any problem with them. Regarding facial hair, Ms. Lavigne never noticed any facial hair on Resident 6 other than having "a couple little whiskers here and there." Ms. Lavigne was Resident 6's treating nurse in the general time-period around the survey in question, and was never informed about any problems with Resident 6 regarding nails or facial hair, nor noticed any. Ms. Endress classified the findings she made regarding Resident 6's nails and hair as a Class II violation because she perceived it as a "dignity issue because women do not like facial hair on them." Ms. McIntyre confirmed the class determined by Ms. Endress, although the record is not clear why. Count II--cleanliness and maintenance Count II of the Amended Administrative Complaint alleges that Kipling Manor failed to honor the rights of residents by not providing a safe and decent living environment to prevent the spread of disease for all residents. The Amended Administrative Complaint alleges in pertinent part as follows: In an interview resident #3 on 7/12/11 at 9:00 am stated this place was not clean. He stated the cook will have gloves on his hands when he leaves the kitchen. The cook continues rolling the food down the hallway to the dining room while simultaneously rolling the open garbage container which is soiled. Without changing his gloves he will serve the food to the residents.1/ An observation of lunch on 7/12/11 at 12:00 pm revealed the cook serving turkey with gloved hands not using a utensil. Without changing his gloves he handled silver ware, moved a gallon of milk and was touching the dining room table. He was using the same gloved hand to serve corn bread. While serving food he never changed his gloves between clean and dirty. Other staff wearing gloves were serving lunch to residents and cleaning tables and pouring beverages without changing gloves. They were serving beverages touching the rims of glasses without changing clothes [sic]. During the survey, the following was seen: Bathroom floor for room 9 on wing 1 was dirty with build-up of dirt in the corners. Lounge area at the end of wing 1 had a broken recliner that was being used by a resident. The floor and furniture were soiled. Room and bathroom #3 on wing 1 had dirty floors with build-up of dirt along baseboards and the toilet lid was too small for the tank. Vents were clogged with dust. The door was too short for the opening; wood was missing on door frame and the threshold had broken tile. Dining room bathroom at the end of wing 2 had dirty floors with build-up of dirt along baseboards; around bottom of the toilet was black and the seal was cracked. Dining room floors were dirty and walls had dried food on them. Room 27 had filthy floors with build up along baseboards; dried spills were noted and the drywall had a hole in it. Wing 2 had drywall that was pulling away from ceiling and the ceiling had brown water spots: soiled dirty walls; dirty baseboards with build up of dust; spills on walls and vents dusty. Wing 2 had no baseboard near the shower; the cabinet had mildew on the outside surface; the wood was warped and peeling. The sink was soiled with dried brown substance. The door to the cabinet would not close. The baseboard wood near sink was split and the drywall had an indentation of the door knob. Room 21 floors were filthy and smelled of urine. Soiled clothes laid on the floor with soiled underwear which were observed while medication technician was assisting resident. No action was taken by the medication technician. Laundry room floors were filthy. There was no division between clean clothes and dirty clothes. Clothes were lying on the floor.2/ Based upon this complaint, Ms. Endress observed the dining room during a meal and toured the building. At hearing, Ms. Endress acknowledged that she did not see the cook touch the garbage pail or garbage and then touch food. She maintained, however, that she observed the cook while wearing gloves, touch food then touch "dirty surfaces," then go back and touch food on plates and touch the rims on glasses. Ms. Endress did not specify at hearing what she meant by "dirty surfaces," but in her report which was the basis for the Amended Administrative Complaint, she noted that the cook would touch food and then touch surfaces such as moving a gallon of milk, touching the dining room table, and handling silver ware. She also testified that she saw other staff wearing gloves who were serving residents, cleaning tables, and serving beverages without changing their gloves. Deborah Jackson is a personal care assistant (PCA), food server, and laundry worker at Kipling Manor. Ms. Jackson and one other PCA serve meals for about 60 residents. She received training in food service. She was working at Kipling Manor the days Ms. Endress was there for the survey. Ms. Jackson always wears gloves when serving the residents. If she touches anything besides food she changes gloves. For example, if she moves chairs, she changes gloves before resuming food service. She has never seen the other PCA touch other items then serve food. She was trained never to touch the rims of the glasses but to pick up glasses and cups from the side. She goes through "probably a whole box" of gloves in a day. According to Ms. Jackson, the cook stands behind the area and puts the food on the plates, preparing two plates at a time. She watches him prepare the plates of food. She and the other PCA then serve the food to the residents. The garbage can is kept in the back, not where food is being served. She has never seen the cook touch the garbage can then prepare plates of food. When he has finished, he takes all "his stuff" out on a cart, while the PCAs clean up. If a resident spilled food, the PCAs, not the cook, would clean it up. L.N. was the cook at the time of the survey inspection. L.N. was hired in April 2011 and received training in infectious control and food service sanitation. L.N. no longer works for Kipling Manor.3/ Billie Williams, as administrator of Kipling Manor, confirmed Ms. Jackson's description of the cook's role in serving dinner. That is, that the cook prepared plates of food and the PCAs then served the residents. At hearing, Ms. Endress essentially reiterated her findings regarding the other allegations in count II dealing with the cleanliness and condition of the facility. No further proof was offered regarding these or any other allegations in the Amended Administrative Complaint. Mr. Williams' testimony contradicted much of what Ms. Endress described regarding the cleanliness and condition of the facility. Specifically, Mr. Williams noted that on the day of the survey inspection, maintenance men were repairing a ceiling leak. The ceiling leak was the cause of the "drywall pulling away from the ceiling" and the "brown water spots" on the ceiling cited in the Amended Administrative Complaint. These conditions were the result of the water leak and were in the process of being repaired at the time of the survey. The workers arrived early in the morning and cut drywall from the ceiling where the water dripped down on it. They necessarily used a ladder to do the ceiling repair work. A maintenance man stood at the bottom of the ladder and, if a resident approached, would escort the resident around the ladder. Regarding the issues of cleanliness, Mr. Williams has two housekeepers, a person who does the laundry, and two maintenance men. Mr. Williams acknowledged that there may be a small wax buildup along baseboards or on the inside corner of a door. However, the two maintenance men wax, strip, and buff the floors throughout the building. The floors are swept and buffed every day. The baseboards (wall to floor) are dust mopped twice a day. Regarding the allegation that there was black around the bottom of the toilet and the seal was cracked in the bathroom off the dining room area, Mr. Williams went to that room with the maintenance men to personally inspect it. He observed some discoloration on the floor where the toilet may have overflowed at some time and got underneath the tile. The maintenance men cleaned this immediately and replaced the tile. Regarding the allegation that there was mildew on a bathroom cabinet, Mr. Williams inspected the black mark and found it to be a tire mark from a wheelchair. He found no mold or mildew. The black mark was removed. There is a separate laundry room where washers and dryers are located. Any clothes on the floor are for sorting or separating by color or other reason prior to washing. Once clothes are washed, they are taken back to the residents' rooms immediately. Clean sheets, towels, and wash cloths are placed on wooden shelves that were built for that purpose. There is no evidence that establishes that clean and dirty clothes were mixed on the floor. Mr. Williams also inspected the recliner. The recliner has snap-on armrests and one had been snapped off. The maintenance men snapped the armrest back on the chair, and it was easily repaired. Regarding the allegation that the drywall in a bathroom had an indentation of the door knob, Mr. Williams inspected that and found that the doorstop on the bottom had broken off. There was an indentation in the wall the size of a doorknob where the door had been opened hard. This was repaired by the maintenance men. Regarding the allegation of vents being clogged with dust in a room and bathroom, Mr. Williams found "a little" dust on a vent which was cleaned immediately by staff. He then instructed staff to check the vents daily for dust build-up. Mr. Williams could not find a door that was too short for the opening, and noted that this would be a fire code violation. Kipling Manor is current on fire and health safety inspections. In general response to the allegations regarding cleanliness and maintenance and to a question asking whether he keeps a well-maintained building, Mr. Williams stated: We try our best. I mean, I have--you know, when you have incontinent residents who are demented, who are bipolar or suffering from depression, they will do things. And, yes, they do. And like, I think in one of the reports she wrote up, there was wet clothes on the floor. Well, if a resident, some of them are semi-independent, too. I mean, they take care of their own needs. If they had an incontinent issue that morning, and they took their clothes off and left it there on the floor, you know, they expect the staff to pick it up and take it to a laundry room when they come through. You know, we do, I think, we do a darn good job given the -- a lot of my residents have been homeless, have never had any structured living. Nobody else in town takes them, but I have. Ms. Endress classified the alleged violations in Count II as Class II "because of the potential for harm to residents which could occur from an unsafe environment and potential spread of infection." Ms. McIntyre agreed with Ms. Endress that "the totality of all the findings are what drove the deficiency to be considered a Class II." Count III--Resident 4 medications Count III alleges that Kipling Manor failed to administer medications according to the medication observation record (MOR) for 1 out of 9 sampled residents (Resident 4). During lunch, Ms. Endress observed Resident 4 become agitated, rub his face, and complain loudly in the dining room. Following an observation of this resident and a conversation with him, Ms. Endress reviewed Resident 4's medication observation record (MOR) and health assessment. Ms. Endress determined that Resident 4 had not been given one of his medications, Interferon, when scheduled. The MOR shows a time for administration as 8 a.m. According to Ms. Endress, on the date this took place, July 12, 2011, the MOR was blank in the box that should be initialed when the medication was administered. The MOR in evidence, however, reflects initials in that box (i.e., it is not blank). When a drug is self-administered, the staff member initials the box for that day. Erica Crenshaw recognized and identified the initials in the box for that day as those of former unit manager Tekara Levine, who trained Ms. Crenshaw. According to Mr. Williams, Ms. Levine, was certified in the self- administration of medications and was a trustworthy employee. Ms. Endress observed Resident 4 wheel himself from the dining room to the medication room and self-administer his medication. This occurred around noon that day. Ms. Endress determined this to be a Class II violation as she believed it directly threatened the resident emotionally. She based this in part on the resident's demeanor before the medication and afterwards, and the comments the resident made to her. Resident 4 is one of Nurse Lavigne's patients. Resident 4 has a diagnosis of MS, major depression, post traumatic stress disorder, a paranoid psychosis, and anxiety and affective disorder. He receives Interferon for his MS. It is injectable and he self-administers it every other day. According to Nurse Lavigne, there is no doctor's order stating that the Interferon must be given at 8 a.m. or any other particular time. The injection can be administered at any time during the day. Resident 4 sometimes gets confused about his medications. He gets extremely upset if he thinks he has not gotten his medications. He will sometimes tell her (Nurse Lavigne) that he did not receive a particular medication when he, in fact, did receive it. Once he is shown the MOR indicating that he has received his medication, he visibly calms down. He does not like to leave his room because he thinks somebody is changing stations on his TV. Regarding his once-a- day medications, staff will wait until he is ready to come out of his room because he can get agitated. He sometimes gets upset if there are a lot of people around him, such as in the dining room. Nurse Lavigne does a full assessment when she sees Resident 4. She was not aware of any problems with Resident 4 during that time period regarding his medications. While the record is unclear as to why Resident 4's MOR shows an administration time of 8 a.m., the evidence established, through Nurse Levine, his treating nurse, that there is no doctor's order requiring that the drug be administered at that particular time. The evidence also established that Resident 4 self-administered his medication at noon on July 14, and that this was initialed by a staff member on his MOR. Count IV--Resident 1 medications As a result of a complaint received, Ms. Endress interviewed residents about their medications and spoke to a new staff member. Based upon these interviews, Ms. Endress determined that one of Resident 1's medications (Flexeril) had not been available for one dose on July 13, 2011, and another of this resident's medications (Visteril) had not been available from June 23 until July 12, 2011). Ms. Endress classified this alleged violation as a Class II because she determined that that it directly affected the resident psychologically and physically. Resident 1 had a diagnosis of COPD and has an anxiety disorder. She is alert and oriented. Resident 1 was prescribed Flexeril to be administered every evening, and Vistaril and Ativan for anxiety. She is to receive Ativan twice a day and PRN (as needed) and Visteril before bed and PRN. Each day a medication is administered, the residents' MORs are initialed by staff in a box indicating each day of the month. However, if the resident runs out of a drug, the staff member will put a circle in the box representing that day and makes a note on the back of the MOR. No circles or notes appear on Resident 1's MOR indicating that either drug was not available. Resident 1 is a patient of Nurse McCormick. Resident 1 becomes anxious or agitated if she does not receive her medication for her anxiety disorder. Nurse McCormick considered Resident 1's anxiety disorder well controlled by the medications. Resident 1's MOR reflects that she received Visteral from June 1 through 30 at night as ordered and received it PRN several times prior to June 23, 2011, but did not receive it PRN the rest of the month of June or July 1 through 14. She also received Ativan twice a day routinely in June and July and five times PRN during the period June 23 through 30, 2011, and four times during the period July 1 through 14. According to Nurse McCormick, either medication was appropriate for controlling Resident 1's anxiety disorder. Resident 1's MOR reflects that she received Flexeril on June 30, 2011. Nurse McCormick was not made aware at any time that Resident 1 was not receiving any of her medications. As the treating and prescribing nurse, missed or unavailable medications would have come to Nurse McCormick's attention. Resident 1 was not anxious, nervous or agitated when interviewed by Ms. Endress on July 12, 2011. There is no competent evidence that Resident 1 displayed any signs of anxiety, nervousness or agitation during the survey or during the times that the Amended Administrative Complaint alleges that she did not receive her medication. Nurse McCormick found the staff of Kipling Manor to be careful with all residents. She has been to the facility at various times of the day from early in the morning to late into the evening. Nurse McCormick is of the opinion that the staff takes care of all its residents and provides them with dignity. Despite Kipling Manor's resident population of seriously mentally ill residents, Nurse McCormick is of the opinion that the facility manages its residents with dignity and care. Count V--Background Check The Amended Administrative Complaint alleges that one staff member of Kipling Manor, the cook, had not been background screened. Based upon record review and staff interview, Ms. Endress determined that the facility did not complete a level 2 background check for 1 out of 8 sampled staff members. A record review revealed that this employee had been hired in April 2011. On April 26, 2011, the employee in question signed an Affidavit of Compliance with Background Screening Requirements, using AHCA form #3100-0008. By signing this form, the employee attested to never having been arrested for, pled nolo contendere to, or convicted of certain disqualifying offenses. Mr. Williams did not complete a background check on the cook because he did not think the cook was covered under the law. That is, he did not think the law applied to the cook because of the lack of personal contact with the residents. The cook is present during meal times serving plates of food to the dining workers who then directly serve the residents. The living areas are accessible to the cook. This employee no longer works at Kipling Manor. The record is not clear as to when he stopped working there. Ms. Endress determined that this constituted a Class II deficiency as she believed that it could potentially lead to harm to residents of the facility. According to Ms. McIntyre, AHCA always imposes a Level II deficiency for failure to have a level 2 background screening for employees. Both Ms. Endress and Ms. McIntyre testified at hearing regarding what constitutes Class II and Class III deficiencies. In several instances, Ms. Endress classified a violation or deficiency that could potentially result in harm to a resident as a Class II. Ms. McIntyre testified that "a potential harm to a resident could be a class II deficiency." She described a Class III as one that "indirectly threatens the physical, emotional health or safety of a resident. . . . indirectly or potentially." The Agency provided a mandatory correction date of August 1, 2011, for all five counts in the Administrative Complaint.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law set forth herein, it is RECOMMENDED: That the Agency for Health Care Administration enter a final order imposing a fine of $2,000, imposing a survey fee of $500, and dismissing the remaining allegations of the Amended Administrative Complaint against Respondent, Kipling Manor. DONE AND ENTERED this 1st day of May, 2012, in Tallahassee, Leon County, Florida. S BARBARA J. STAROS Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 1st day of May, 2012.
The Issue Whether Emergency Rule 10CER92-4 should be invalidated because it constitutes an invalid exercise of delegated legislative authority.
Findings Of Fact The Medicaid program is a program authorized under Title XIX of the federal Social Security Act that provides for payments for medical items or services for eligible recipients. Section 409.901(7), Florida Statutes. Prior to July 1, 1993, the Medicaid program was administered by the Department of Health and Rehabilitative Services (HRS). Effective July 1, 1993, Section 20.42, Florida Statutes, 1992 Supplement, was amended by Chapter 93-129, Section 58, Laws of Florida, to give the Agency for Health Care Administration (AHCA) the responsibility for the Medicaid program. The Medicaid program provides for mandatory and optional services to eligible recipients. Prescribed drug services are optional Medicaid services. Medicaid services may be provided only when medically necessary, must be provided in accordance with state and federal law, and are subject to any limitation established by the general appropriations act or Chapter 216, Florida Statutes. Sections 409.905 and 409.906, Florida Statutes. Medical providers participating in the Medicaid program receive reimbursement from Medicaid. Section 409.908, Florida Statutes. States are given the option to charge Medicaid recipients copayments for services. 42 CFR Section 447.50. Certain categories of services and recipients are exempt from copayments. 42 CFR Section 447.53. Forty-five percent of the Medicaid program is funded by state funds and fifty-five percent is funded with federal "matching funds." In order to receive federal matching funds for its Medicaid program, the state must submit a plan describing the nature and scope of its Medicaid program and giving assurances that the program will be administered in accordance with Title XIX and applicable federal regulations. This plan is known as the State plan. Effective February 14, 1992, the Legislature enacted Chapter 92-5, Laws of Florida, which amended the appropriations Act for fiscal year 1991-92. Proviso language in Chapter 92-5 relating to Specific Appropriation 1035 for Medicaid prescribed medicine/drug provides: The Department of Health and Rehabilitative Services is directed to implement, beginning April 1, 1992, a co-payment program for Prescribed Medicine in order to implement spending reductions of at least $770,213 from general revenue and $929,661 from the Medical Care Trust Fund in Specific Appropriation 1035. The State plan was amended effective April 10, 1992, to require a copayment of $1.00 per prescription for pharmacy services provided to Medicaid recipients. Certain categories of services and recipients were exempted from the copayment requirement. Providers were prohibited from denying services to recipients who were unable to pay the copayment. Prior to April 10, 1992, copayments had not been required for prescribed drug services. HRS adopted Emergency Rule 10CER92-4, effective April 10, 1992. HRS published notice of the emergency rule in the Florida Administrative Weekly, Vol. 18, No. 16, April 17, 1992. In this notice under the section entitled "SPECIFIC REASONS FOR FINDING AN IMMEDIATE DANGER TO THE PUBLIC HEALTH, SAFETY OR WELFARE," it states in pertinent part: The 1992 Legislature reduced the prescribed drug services program FY 1991-1992 budget in Senate Bill 2408 which was signed by the Governor on February 14, 1992. This law requires the Medicaid program to implement a copayment requirement for prescription drugs by April 1992. . . . The emergency rule amended Rule 10C-7.042, Florida Administrative Code and required recipients to pay the pharmacy provider a $1.00 co-payment for each prescription or other prescribed drug service reimbursed by Medicaid. Certain categories of recipients and services were exempted from the copayment requirement. The pharmacy provider was required to request a copayment from non-exempt recipients. The pharmacy must determine a recipient's ability to pay the copayment based on the recipient's reply to the request for copayment, the recipient's past purchase history with that provider, and the recipient's recent purchase of non-essential items. A provider could not deny prescribed drug services to eligible recipients because of inability to pay the copayment. Although a recipient may not be able to pay the copayment, the recipient remains liable for the copayment. HRS began the rulemaking process to adopt the same amendments to Rule 10C-7.042 as a regular rule. Emergency Rule 10CER92-4 was challenged via a lawsuit in state court and was later removed to federal court. The proposed amendments to Rule 10C-7.042 were challenged in an administrative rule challenge, which was withdrawn and added to the lawsuit in federal court dealing with the challenge to the emergency rule. Chapter 92-293, Laws of Florida, the Appropriations Act for fiscal year beginning July 1, 1992 and ending June 30, 1993 contains the following proviso language relating to Medicaid prescribed drug services: Funds in Specific Appropriation 1019 are reduced by $18,581,894 from the General Revenue Fund, $3,281,004 from the Grants and Donations Trust Fund, $22,647,089 from the Medical Care Trust Fund, $2,632,000 from the Public Medical Assistance Trust Fund, and $58,013 from the Special Grants Trust Fund for the Department to implement a Medicaid comprehensive cost containment program. This program shall, at a minimum, incorporate: a prior authorization component; a co-payment program; an on site education program for providers prescribing the drugs; enhancements to the Department's ability to identify fraud and abuse; utilization of specific nursing home pharmacy consultants; and, shall implement new electronic technology to speed payments and capture third party liability information. By notice in the Florida Administrative Weekly, Rule 10CER92-4 has been continued pursuant to Section 120.54(9)(c), Florida Statutes. Chapter 93-184, Laws of Florida, the Appropriations Act for the fiscal year beginning July 1, 1993 and ending June 30, 1994, contains no language concerning reductions in the appropriations for Medicaid prescription medicine services and contains no language concerning copayments for recipients receiving Medicaid prescription medicine services. The amounts appropriated for the Medicaid prescription medicine services was at or below the amounts appropriated in Chapter 92-293 Laws of Florida. Chapter 93-129, Section 48, Laws of Florida, created section 409.9081, Florida Statutes, which requires Medicaid recipients to pay nominal copayments for hospital outpatient services and physician services effective July 1, 1993. Prior to the enactment of section 409.9081, Florida Statutes, a one dollar copayment had been required for Medicaid outpatient hospital and physician service. Effective July 1, 1993, the copayments were raised to two dollars. Current revenues generated by the copayments for the Medicaid prescribed drug services is approximately $12 million. Thus, the discontinuance of the copayment would result in a $12 million shortfall for the provision of Medicaid prescribed drug services, and a restriction on services to the extent necessary to account for the shortfall. The Social Services Estimating Conference (SSEC) is a statutorily created body established to develop official information relating to the social service system of the state for use in the state planning and budgeting system. Section 216.136(6), Florida Statutes. Section 216.134(1), Florida Statutes, provides in pertinent part: Unless otherwise provided by law or decided by unanimous agreement of the principals of the conference, all official information developed by the conference shall be based on the assumption that current law and current administrative practices will remain in effect throughout the period for which the official information is to be used. . . . The social services estimating conference for 1993-94 took into consideration the revenues from the copayments for the Medicaid prescribed drug services. Petitioner, Mildred Henry, resides in Jacksonville, Florida, and is disabled. She has received Medicaid since December, 1991. Her only income is Supplemental Income ("SSI") benefits of $434 per month. Ms. Henry suffers from many disabilities including chronic obstructive pulmonary disease, asthma, hypertension, severe and chronic urinary tract infections, and depression. Her physicians have prescribed a number of medications to address these conditions including Cardizem (for high blood pressure), Zantac (for ulcers), Cipro (for chronic urinary tract infections), Phenazopyridine (for bladder problems), Imipramine (for depression), Premarin (hormone), Thes-dur (for asthma), Brethine (for asthma), Ventalin (for asthma), Furosemide (for excess fluid), K-Dur (potassium), Propoxy N (for pain), Nizoral (for skin irritations), Darvoset (for pain), Tylenol 3 (for pain), and Halcion (for anxiety). She needs to refill most of these prescriptions each month. Copayments for all of Ms. Henry's prescription medications amount to $16.00. Ms. Henry's income is below the federal poverty level. She cannot afford to pay a copayment for all her medications. Petitioner has informed her pharmacy that she does not have the money to pay copayments. However, the pharmacy has refused to provide the medications without payment of the co-payments. As a result, Petitioner runs out of medications and delays getting her prescriptions refilled until she can pay the copayment.
The Issue Whether Petitioner was overpaid by the Florida Medicaid Program and, if so, the amount of the overpayment.
Findings Of Fact At all times material to this proceeding, Respondent has been the state agency charged with responsibility for overseeing the Florida Medicaid Program, including the recovery of overpayments to Medicaid providers pursuant to Section 409.913, Florida Statutes. At all times material to this proceeding, Petitioner was an authorized Medicaid provider, having been issued provider number 377290000. Petitioner had valid Medicaid Provider Agreements with the Agency for Health Care Administration (AHCA) during the Audit Period, which began on January 1, 1996, and ended on May 10, 1999. Petitioner graduated from the University of Puerto Rico School of Medicine in 1987, did an internship at Tulane University, did a residency in internal medicine at Eastern Virginia Graduate Medical School, and did a fellowship in hematology at Washington Hospital Center. He served as Chief of Hematology for Kessler Medical Center in Biloxi, Mississippi, while serving in the United States Air Force (with the rank of major). At the time of the final hearing, Petitioner was licensed to practice medicine in Florida, Virginia, Puerto Rico, and Washington, D.C. At the time of the final hearing, Petitioner was employed by the National Institutes of Health (NIH) as a Medical Officer, Health Scientist Administrator. Petitioner served as an advisor to the director of the NIH on issues related to HIV (human immunodeficiency virus) and AIDS (acquired immunodeficiency syndrome). Petitioner’s specialty is internal medicine with a sub- specialty in hematology. Petitioner has extensive experience treating persons suffering with HIV and AIDS dating back to 1987. Pursuant to his Medicaid Provider Agreements, Petitioner agreed to: (1) retain for five years complete and accurate medical records that fully justify and disclose the extent of the services rendered and billings made under the Medicaid program; (2) bill Medicaid only for services or goods that are medically necessary; and (3) abide by the Florida Administrative Code, Florida Statutes, policies, procedures, manuals of the Florida Medicaid Program and Federal laws and regulations. Respondent audited Petitioner’s Medicaid claims during the Audit Period and conducted a peer review of Petitioner’s billings and medical records of 25 of Petitioner’s patients as part of that audit.2 Joseph W. Shands, M.D., conducted the peer review of the documentation provided by Petitioner for purposes of the audit conducted by AHCA. Dr. Shands first reviewed documentation provided by Petitioner in 1999. He had no further participation in the audit until he reviewed information in preparation for his deposition in this proceeding. Dr. Shands graduated from medical school in 1956, trained in internal medicine, and worked as a microbiologist for approximately 15 years. He served as Chief of Infectious Diseases at the University of Florida for 23 years and also treated patients through the Alachua County Public Health Department and Shands Hospital at the University of Florida. Dr. Shands' practice was devoted almost entirely to the treatment of patients diagnosed with HIV/AIDS. Dr. Shands retired from the practice of medicine in May 2002. For three years prior to his retirement, Dr. Shands practiced medicine part-time. Petitioner was sent a Preliminary Agency Audit Report (PAAR) dated May 25, 1999, that found an overpayment in the amount of $862,576.72. In response to that PAAR, Petitioner had the attorney representing him at that time respond to AHCA in writing. The letter from the attorney, dated June 2, 1999, requested a copy of AHCA’s supporting materials and clarification of certain matters. AHCA did not respond. AHCA issued its FAAR on January 22, 2004, asserting that Petitioner was overpaid by the Florida Medicaid Program in the total amount of $261,336.14 for services that in whole or in part were not covered by Medicaid. There was no plausible explanation why the FAAR was not issued until 2004, whereas the audit period ended in 1999. The difference between the amount of the alleged overpayment reflected by the PAAR and the amount of the alleged overpayment reflected by the FAAR is attributable to the use of different methodologies in calculating the amounts overpaid. The FAAR used the correct methodology that was not challenged by Petitioner. The FAAR sets forth five categories of alleged overpayments. Each category accurately describes an overpayment based on applicable Medicaid billing criteria. The five categories are as follows: Medicaid policy specifies how medical records must be maintained. A review of your medical records revealed that some service for which you billed and received payment were not documented. Medicaid requires documentation of the services and considers payments made for services not appropriately documented an overpayment. (For ease of reference, this will be referred to as Category I.) Medicaid policy defines the varying levels of care and expertise required for the evaluation and management procedure codes for office visits. The documentation you provided supports a lower level of office visit than the one for which you billed and received payment. The difference between the amount you were paid and the correct payment for the appropriate level of service is considered an overpayment. (For ease of reference, this will be referred to as Category II.) Medicaid policy addresses the type of pathology services covered by Medicaid. You billed and received payment for laboratory tests that were performed outside your facility by an independent laboratory. Payments made to you in these instances are considered overpayments. (For ease of reference, this will be referred to as Category III.) Medicaid policy requires the Medicaid services be provided by or under the personal supervision of a physician. Personal supervision is defined as the physician being in the building when the services are rendered and signing and dating the medical records within twenty-four hours of service delivery. You billed and received payment for services which your medical records reflect you neither personally provided nor supervised. Payment made to you for all or a part of those services is considered an overpayment. (For ease of reference, this will be referred to as Category IV.) Medicaid policy requires services performed be medically necessary for the diagnosis and treatment of an illness. You billed and received payments for services for which the medical records, when reviewed by a Medicaid physician consultant, indicated that the services provided did not meet the Medicaid criteria for medical necessity. The claims which were considered medically unnecessary were disallowed and the money you were paid for these procedures is considered an overpayment. (For ease of reference, this will be referred to as Category V.) CATEGORY I CLAIMS The disputed Category I claims can be separated into two subcategories: services performed while an employee of a corporate employer and services performed while a recipient was hospitalized. As to both subcategories Petitioner argues that he has been prejudiced by Respondent’s delay in issuing the FAAR because Medicaid requires providers to retain medical records only for five years from the date of service.3 Although Respondent was dilatory in prosecuting this matter, Petitioner’s argument that Respondent should be barred (presumably on equitable grounds such as the doctrine of laches) should be rejected. Petitioner has cited no case law in support of his contention, and it is clear that any equitable relief to which Petitioner may be entitled should come from a court of competent jurisdiction, not from this forum or from an administrative agency. All billings for which there are no medical records justifying the services rendered should be denied. CATEGORY II CLAIMS The following findings as to the Category II claims are based on the testimony of the witnesses and on the information contained in the exhibits.4 Although nothing in the record prior to the final hearing reflects that position, Petitioner did not dispute most of the down-codings at the final hearing. Office visits, whether supported by a doctor’s note or a nurse’s note, for the sole purpose of administering IVIG treatment, will be discussed in the section of this Recommended Order dealing with Category V claims. The office visits, which were for the purpose of intravenous immunoglobulin (IVIG) treatment and for other reimbursable medical services, are set forth as part of the Category II disputes. The following findings resolve the Category II disputes. The date listed is the date the service was rendered. The billing code following the date is the billing code that is supported by the greater weight of the evidence. Recipient 1:5 01-20-98 99213 Recipient 2 09-27-96 99214 10-10-96 99213 11-13-96 99214 12-23-96 99212 02-24-97 99214 04-21-97 99213 04-28-97 99214 05-21-97 99213 06-02-97 99213 07-09-97 99213 07-23-97 99212 08-06-97 99213 08-11-97 99212 10-01-97 99213 10-10-97 99213 10-15-97 99214 10-21-97 99214 11-10-97 99213 12-08-97 99213 12-17-97 99213 12-29-97 99213 01-21-98 99213 Recipient 3 10-21-97 99213 11-04-97 99213 11-25-97 99213 12-16-97 99213 01-27-98 99214 02-26-98 99214 Recipient 4 01-03-98 99254 01-04-98 99261 01-05-98 99261 Recipient 5 09-29-97 99204 Recipient 6 11-11-97 99204 11-18-97 99213 Recipient 7 01-26-98 99204 02-23-98 99213 Recipient 8 09-26-96 99214 09-30-96 99213 10-03-96 99213 10-10-96 99212 10-25-96 99214 11-29-96 99213 12-04-96 99213 12-30-96 99213 01-22-97 99214 01-31-97 99211 02-14-97 99212 03-17-97 99214 04-04-97 99213 04-25-97 99212 05-30-97 99211 07-11-97 99213 08-08-97 99213 08-22-97 99213 09-05-97 99212 09-19-97 99214 10-31-97 99214 11-24-97 99214 12-03-97 99213 12-29-97 99213 01-09-98 99214 01-16-98 99213 01-30-98 99214 02-13-98 99214 Recipient 9 11-24-97 99203 Recipient 10 10-14-96 99205 11-04-96 99213 11-11-96 99213 11-25-96 99214 12-30-96 99213 01-27-97 99214 02-24-97 99214 03-10-97 99213 03-24-97 99212 04-07-97 99213 04-21-97 99214 05-05-97 99212 05-19-97 99213 05-21-97 Deny 06-09-97 99213 07-07-97 99212 08-04-97 99213 08-18-97 99213 09-24-97 992136 10-06-97 99213 10-10-97 99214 10-27-97 99213 11-10-97 99213 11-19-97 99214 11-24-97 99213 12-08-97 99213 02-02-98 99213 Recipient 11 06-30-97 99204 11-06-97 Recipient 12 Deny due to lack of documentation. 10-14-97 99213 11-06-97 99204 11-20-97 99213 12-16-97 99213 01-06-98 99213 Recipient 13 There are no Category II billings at issue for this Recipient. Recipient 14 There are no Category II billings at issue for this Recipient. Recipient 15 09-16-97 992157 Recipient 16 02-19-98 99212 Recipient 17 There are no Category II billings at issue for this Recipient. Recipient 18 There are no Category II billings at issue for this Recipient. Recipient 19 09-27-96 99212 10-01-96 99213 10-10-96 99213 10-23-96 99213 11-06-96 99213 11-20-96 99213 12-18-96 99211 12-30-96 Deny due to lack of 01-09-97 documentation. Deny due to lack of 01-22-97 documentation. 99211 02-05-97 99214 03-05-97 99214 03-19-97 99211 03-24-97 99214 03-26-97 04-02-97 Deny due to lack documentation. 99213 of 04-21-97 99213 05-05-97 99212 05-19-97 99213 06-02-97 99212 06-30-97 99213 07-07-97 99213 07-14-97 99213 07-28-97 99212 08-18-97 99213 08-25-97 99213 09-08-97 99213 09-15-97 99214 09-22-97 99213 10-28-97 99214 11-04-97 11-07-97 Deny due to lack documentation. 99213 of 11-24-97 99213 12-29-97 99213 01-12-98 99213 01-26-98 99213 02-19-98 99214 02-23-98 99213 Recipient 20 12-04-96 99204 12-13-96 99213 01-03-97 99213 01-17-97 99213 01-27-97 99213 02-07-97 99214 02-21-97 99213 03-07-97 99214 03-21-97 99212 04-04-97 99214 04-21-97 99212 05-06-97 99213 06-04-97 99213 06-13-97 99213 06-30-97 99213 07-14-97 99213 08-04-97 99213 01-19-98 99213 Recipient 21 04-29-97 99204 05-13-97 99214 05-16-97 99213 05-23-97 99212 06-09-97 99212 06-23-97 99212 07-11-97 99211 07-25-97 99213 08-11-97 99213 09-10-97 99213 11-05-97 99214 11-19-97 99213 12-22-97 99213 01-07-98 99214 01-21-98 99213 02-04-98 99213 Recipient 22 02-16-98 99205 02-20-98 99213 02-23-98 99213 Recipient 23 06-23-97 99215 10-02-97 992138 Recipient 24 There are no Category II billings at issue for this Recipient. Recipient 25 01-24-97 99213 02-07-97 99213 02-24-97 99212 03-10-97 99213 03-24-97 99212 05-05-97 99212 05-19-97 99212 06-02-97 99212 06-16-97 99212 07-14-97 99213 07-23-97 99212 07-28-97 99213 08-18-97 99213 08-25-97 99213 09-15-97 99213 10-01-97 99213 10-13-97 99213 10-27-97 99214 12-08-97 99213 12-22-97 99213 12-29-97 99213 01-13-98 99212 01-19-98 99214 02-02-98 99212 CATEGORY III As set forth in the Physician Coverage and Limitation Handbook (Respondent’s Exhibit 6), Petitioner is not entitled to billings for laboratory tests that were performed outside his facility by an independent laboratory. The only billing arguably in Category III is the billing for Recipient 1 on February 19, 1998. That billing should have been approved because it was for a urinalysis by dip stick or tablet that was administered and analyzed by Petitioner. It was not analyzed by an independent laboratory. CATEGORY IV All Category IV billings pertained to Petitioner’s supervision of his staff while patients were receiving treatments of IVIG. Those billings will be subsumed in the Category V billings discussion. CATEGORY V The alleged Category V overpayments relate to Petitioner’s IVIG treatment of Patients 2, 8, 10, 19, 20, 21, and 25, each of whom was an adult diagnosed with AIDS. In many of these cases a nurse administered the IVIG treatment. A dispute as to whether Petitioner properly supervised the nurse while he or she administered the IVIG treatment is moot because of the findings pertaining to the IVIG treatments set forth in Paragraphs 20 and 21. The Physician Coverage and Limitations Handbook requires that rendered services be medically necessary, as follows: Medicaid reimburses for services that are determined medically necessary and do not duplicate another provider’s service. In addition, the services must meet the following criteria: the services must be individualized, specific, consistent with symptoms or confirmed diagnosis of the illness or injury under treatment, and not in excess of the recipient’s needs; the services cannot be experimental or investigational; the services must reflect the level of services that can be safely furnished, and for which no equally effective and more conservative or less costly treatment is available statewide; and the services must be furnished in a manner not primarily intended for the convenience of the recipient, the recipient’s caretaker, or the provider. The use of IVIG in adult AIDS patients is not approved by the Federal Drug Administration (FDA). The use of a drug for a purpose other than the uses approved by the FDA is referred to as an “off-label” use. The off-label use of IVIG in adult AIDS patients is not effective either from a medical standpoint or from an economic standpoint. There was a conflict in the evidence as to whether any of the Recipients at issue in this proceeding had a medical condition or conditions other than AIDS that would justify the IVIG treatment administered by Petitioner. The following finding resolves that conflict. Utilizing applicable Medicaid billing criteria, the medical records produced by Petitioner fail to document that any of the Recipients at issue in this proceeding had a medical condition or conditions that warranted treatment with IVIG.9 All of Petitioner’s billings for IVIG treatments for Recipients 2, 8, 10, 19, 20, 21, and 25 were properly denied under the rationale of the FAAR’s Category V. Included in the billings that were properly denied were billings for office visits (whether documented by a doctor’s note or a nurse’s note) when the sole purpose of the office visit was the administration of an IVIG treatment.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order adopting the Findings of Fact and Conclusions of Law set forth in this Recommended Order. It is further RECOMMENDED that the Final Order require that Petitioner repay the sum of the overpayment as determined by Respondent’s staff based on the Findings of Fact set forth in this Recommended Order. DONE AND ENTERED this 20th day of January, 2005, in Tallahassee, Leon County, Florida. S CLAUDE B. ARRINGTON Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 20th day of January, 2005.
