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STATE OF NORTH CAROLINA IN THE OFFICE OF ADMINISTRATIVE HEARINGS COUNTY OF HARNETT 03 DHR 0884 ______________________________________________________________________________ WALTER RAY NELSON, JR. KAREN MARIE NELSON Petitioners, ) ) ) ) v. ) DECISION ) N.C. DEPARTMENT OF HEALTH AND ) HUMAN SERVICES, ) Respondent. ) ______________________________________________________________________________ On October 23, 2003, and December 17-18, 2003, Administrative Law Judge Melissa Owens Lassiter, conducted an administrative hearing in this contested case in Fayetteville, North Carolina. On April 1, 2004, the parties submitted proposed Decisions. APPEARANCES For Petitioners: Pauline F. Laubinger Special Counsel NC Governor’s Advocacy Council for Persons with Disabilities 1010 Richardson Drive Raleigh, NC 27603-2114 For Respondent: Emery E. Milliken Assistant Attorney General N. C. Dept. of Justice Post Office Box 629 Raleigh, North Carolina 27602 ISSUE Whether Respondent acted properly when it concluded that private duty nursing services (“PDN”) were not medically necessary for Stacey Nelson, and therefore, denied Medicaid coverage for such services for Stacey Nelson? APPLICABLE LAW AND AUTHORITY Social Security Act, Title XIX North Carolina Medicaid State Plan 10A N.C.A.C. 22O.0122 42 C.F.R. § 440.80 North Carolina Community Care Manual WITNESSES For Petitioners: Helen Williams Karen Marie Nelson Dr. Michael Byron Tennison Brechelle Lashaun Pinkett For Respondent: Alison Rosa Lee Weatherman Alicia Clark EXHIBITS For Petitioners: 1 through 21 For Respondent: 1, 2A, 2B (pages 21-32), 2C, 2D, 2E, 2F, 3, FINDINGS OF FACT Background Facts 1. Stacey Nelson, (“Stacey”), is a 22 year old female with a principal diagnosis of dysautonomia. Stacey’s other pertinent diagnoses are: static encephalopathy, neurogenic bladder, seizures, pancytopenia, apnea, hypoglycemia, and intestinal pseudo-obstruction. She is ambulatory, and performs some of her daily living activities with constant prompting by her parents and nurse. 2. Stacey lives with her mother and father (Petitioners). She has successfully obtained her high school diploma, and with her parents’ assistance, completed a driver’s education course. However, Stacey does not drive, and is not able to get into a car and drive by herself. (T pp 396 and 409). 3. From 1988 to 1990, and from 1992 to February 28, 2001, Stacey received nursing services under the Medicaid program of Community Alternative Programs for Children (“CAP/C”). During that time, Stacey also received special education services. In 1995, registered nurse Helen Williams began providing nursing services to Stacey, including in the educational setting, whether it be at home or at school (T pp 21-23). Stacey was actually on homebound services for her last two or three years of school, but attended school when she was able to do so. Stacey never attended school five days a week without having a nurse with her. (T p 408) Stacey’s CAP/C services ended, because Stacey aged out of the program the day before her nineteenth birthday. (T pp 154-155). 4. Stacey began receiving Medicaid PDN coverage after her CAP/C services ended, with no break in services between the two coverages. (T pp 154-155). 5. By letter dated February 18, 2002, Respondent’s Nursing Services Coordinator, Allison 2 Weatherman, renewed Respondent’s authorization for Medicaid PDN coverage for Stacey, and authorized 15 hours per day of PDN for Stacey, effective February 1, 2002 – April 1, 2002. (Pet Exh 5) 6. Effective March 11, 2002, Ms. Weatherman changed Respondent’s authorization for Medicaid PDN coverage for Stacey to 15 hours per day of PDN for three days a week, and 8 hours per day of PDN for two days a week, such coverage being effective through April 1, 2002. (Pet Exh 6) 7. On April 12, 2003, Ms. Weatherman renewed Respondent’s authorization for Medicaid PDN coverage for Stacey for 15 hours per day of PDN for three days a week, and 8 hours per day of PDN for two days a week. Such coverage was effective through June 1, 2002. (Pet Exh 7) 8. Every two months thereafter, until February 1, 2003, Ms. Weatherman renewed Respondent’s authorization of Medicaid PDN coverage for Stacey for the same above-stated hours per week. (Pet Exhs 8, 9, 10, 12) During this time, however, Stacey actually only received approximately 40 hours a week of PDN coverage, from 8 a.m. to 4 p.m. weekdays, because of staffing problems at the provider agency, Pediatric Services of America (“PSA”). (T pp 165-166) Denial of Medicaid PDN Coverage At Issue 9. As Stacey was already receiving PDN coverage, this case involved a routine sixty-day renewal for Medicaid PDN coverage. For the period February 01, 2003 – April 1, 2003, Petitioners requested PDN services for Stacey to continue for 15 hours per day of PDN for three days a week, and eight hours per day of PDN for two days a week. 10. By letter dated February 18, 2003, Respondent’s Nursing Services Consultant Allison Weatherman authorized PDN for Stacey to continue at 15 hours per day, three days a week, and eight hours per day, two days a week for the period February 01, 2003 – March 3, 2003. However, effective 03/04/03, Ms. Weatherman terminated Stacey’s PDN because “the patient did not meet the criteria for Medicaid PDN.” (Pet Exh 12) 11. Ms. Weatherman has been employed as a Medicaid PDN consultant for Respondent’s Division of Medical Assistance (“DMA”) since January 2002. She reviews approximately 130 - 150 PDN cases on a monthly basis to determine whether recipients qualify for PDN. She determines initial referrals for PDN, and sixty-day renewals for PDN. For renewals, Ms Weatherman always reviews the HCFA 485 (Plan of Care) and the HCFA 486 (Medical Update). 12. As part of quality assurance and review, Weatherman randomly selects approximately ten (10) cases each month where she reviews additional documentation, such as nurses’ notes, medication administration records, and other relevant documentation. Time constraints do not allow her to review all of this documentation in every case, every time. 13. As part of the review process in this case, for the period 02/01/03 - 04/01/03, Ms Weatherman, obtained additional records such as January 27-31, 2003, and February 12-14, 2003 3 nursing notes and flow sheets, February 25, 2003 skilled nursing visit report, and January 2003 medical administration records for Stacey. 14. According to Ms. Weatherman, these additional records gave a more accurate reflection of Stacey’s true clinical picture. In Weatherman’s opinion, these additional records showed that Stacey’s HCFA 485 (Plan of Care) and the HCFA 486 (Medical Update) did not accurately reflect Stacey’s true clinical picture. a) In her analysis, Weatherman compared the orders and disciplines contained in Stacey’s HCFA 485 Plan of Care to the care that was documented in the nursing notes and medication administration records. Weatherman’s comparison showed that many of the orders and disciplines noted in Stacey’s Plan of Care, were not documented in the nursing notes and medical records as being administered at all, or were documented as being administered infrequently. b) For example, the HCFA 485 Plan of Care ordered oxygen at two liters per minute if Stacey’s temperature was greater than 103 degrees or her heart rate was sustained at greater than 150 beats per minute. Yet, a review of the day to day nursing routine showed that Stacey was not on oxygen, but rather, was on room air. Weatherman’s comparison of these records also showed: vital signs were within normal limits, Stacey was receiving routine care, routine medications were administered twice daily via central venous line, and there was one blood draw. c) Ms. Weatherman found that the nursing interventions performed for Stacey were routine, and her medication administration was typically routine, rather than as needed (“prn”). The HCFA 485 Plan of Care included a lengthy list of medications to be administered prn. Weatherman’s review of these records showed that most of the prn meds were not administered during the period reviewed, or administered infrequently. 15. In Weatherman’s opinion, the medical evidence showed that Stacey’s medical condition had remained substantially the same for the period January 2000 through the time of trial in December 2003. Based upon this fact, although Respondent’s decision pertained to the time period 02/01/03 04/01/03, medical records and testimony regarding Stacey’s medical condition for the period prior to the time in question were admitted into evidence. On this same basis, medical records and testimony regarding Stacey’s medical condition for the period subsequent to the hearing date were admitted into evidence. . 16. Dr. Michael Tennison is Stacey’s pediatric neurologist, who has been treating Stacey for approximately 18 years. Tennison works at the Neurology and Pediatric Department at UNC Medical School. At some point, Ms. Weatherman asked Dr. Tennison to write a letter as to whether Stacey’s condition warranted “nursing care.” 17. By letter dated March 17, 2003, Dr. Tennison advised Respondent that Stacey: has a wide array of very complicated medical issues and is surviving on total parental nutrition (“TPN”) with no appreciable oral/enteral feedings. She is in need of a private duty nurse as she requires knowledgeable assessments and in some cases 4 quick decisions and responses. . . . With her current level of care, problems are caught and treated before they become a major issue thereby preventing further complications and decreased admissions to the hospital. The family has a variety of emergency drugs including IV antibiotics, pain meds, . . . Cath Flo (tpa for catheter clearance) stored and available for quick intervention. To stop her nursing care[,] puts the child at serious risk and I cannot condone such a move. . . . this child has substantial and potentially life-threatening needs and must have ongoing private duty nursing supplied in some way. Your removal of such care will expose this patient to unacceptable risk. (Pet Exh 19) It appears that Respondent received Dr. Tennison’s letter after Ms. Weatherman’s March 3, 2002 denial of continued PDN coverage for Stacey, effective March 4, 2003. 18. Petitioner appealed Ms. Weatherman’s termination of Medicaid PDN coverage for Stacey, and requested a reconsideration review of Weatherman’s decision. 19. On March 26, 2003, Respondent’s Chief Hearing Officer Mary Jo Coward conducted a reconsideration review. Ms. Weatherman presented information to support her initial decision to terminate PDN for Stacey, including: a) b) c) d) e) the HCFA 485 Plan of Care for February 1, 2003 – April 1, 2003, the HCFA 486 Medical Update of January 31, 2003, nursing notes for January 27-31, 2003 and February 12-14, 2003, Skilled Nursing Visit report dated February 25, 2003, and Medical Administration Records for January 2003. At this review, Petitioners presented a March 21, 2003 letter from Petitioner Karen Nelson; March 20, 2003 letter from Dr. Tennison; March 3, 2003 letter from Stacey’s former nurse, Helen Williams; and an unsigned document entitled “Stacey Nelson DMA Hearing scheduled for March 26, 2003.” 20. By letter dated March 27, 2003, Respondent denied Petitioners’ request for PDN for the period March 4, 2003 – April 1, 2003, because Stacey “did not meet the criteria for Medicaid PDN.” In this letter, Respondent stated the following grounds for denying continued Medicaid PDN coverage for Stacey: The medical record documentation presented at the reconsideration review support the conclusion that the care that Stacey Nelson routinely requires is not consistent with the continuous, substantial and complex nursing services described in its Medicaid guidelines for PDN services. Certainly, Stacey requires a tremendous amount of care; however, the skilled nursing interventions that are documented are episodic, not continuous. (Pet Exh 13, p 8 of March 27, 2003 denial letter) 5 Analysis 21. Stacey has a Hickman or Broviac catheter that comes out her chest, and is a central intravenous line. This catheter is a double lumen catheter, and its size is known as a pediatric seven French. One port is used for Stacey’s nutrition, and the other port is used medication administration. (T pp 39, 170-172) While these ports lie side by side, the substances introduced into each port do not mix, and the substances coming out of the ports do not mix. (T pp 243-244). (See Pet Exh 3 for illustration of location of catheter) The Hickman catheter is always a concern because it is a foreign body in the bloodstream. Thus, the need for a sterile technique is vital as the line leads into her heart. A nurse, and not a CAN, may touch and deal with a central line such as Stacey’s. (Transcript I, pages 220-223). 22. At the time of the administrative hearing, Stacey’s catheter/line was located on the right side of her chest and had been since September 30, 2003. The location had been changed because Stacey was having considerable pain during her TPN infusion, and had to be sitting totally upright to have the infusion. After the line replacement surgery, TPA, a clot buster, was prescribed and was to be put into both ports. However, the TPA did not work, the line still did not work properly, a second procedure was necessary. Even after the second line replacement, Stacey had to lie flat or sit perfectly straight to get her TPN. (T pp 176-177). A CNA could not have put the TPA into the line. (T pp 177-179). 23. Stacey typically has a lower white blood count than is normal, and is thus more susceptible to, and cannot fight off infections. In addition, she bruises more easily than normal, and has a slower clotting time when she gets a cut, because her platelet count is low. Because of Stacey’s low white count, the number of persons dealing with the central line needs to be restricted, and even family members, with the exception of Mrs. Nelson, do not touch the central line. (T pp 220-223). 24. Stacey receives all of her nutrition by total parenteral nutrition (“TPN”), because her digestive system can absorb no nutrients from food. This condition is the result of Stacey’s complete shutdown of her digestive organs that she experienced as a young child. The TPN is a concentrated sugar solution with protein, and contains all of the nutrients needed to sustain life, as well as some medications. These nutrients include dextrose (sugar), amino acid, zinc, manganese, chromium, selenium, and Carnitine. Intralipids (fats) are added just before infusion as they break down otherwise. (T pp 184-187). In addition, vitamins, including C, A, D, B-1, B-2, B-6, niacinamide, E, and K, as well as folic acid, are added to the TPN bag just before administration, because of stability issues with being added beforehand. (T p 188). One day a week, Stacey receives iron in the TPN, not the lipids, because the iron and lipids are incompatible with each other. (T p189). 25. The TPN is infused by using a Curlin pump as of June or July of 2003. The pump permits better monitoring of line pressure.(T p190-191). The administration of the TPN is a sterile technique done by a person who must wear gloves and a mask. The person preparing the TPN uses an antiseptic that kills on a hard surface, to scrub the port used for the TPN, and the TPN bag. (T pp 187-188). 26. At the time of the hearing in October 2003, the TPN was supposed to infuse during a ten to twelve hour timeframe; however, infusion was taking fifteen to sixteen hours because movement by 6 Stacey was causing alarms to go off and interrupt the process. All attempts to address the TPN situation would have to be done by a nurse rather than a CAN, because continual access to the central line would be required to try to keep the TPN infusion going. (T pp 181-182). 27. Stacey needs medical intervention to assure that the sugar levels in her blood do not drop too quickly. It is infused initially at a rapid rate, and then is tapered off over a two hour period, so that Stacey’s blood sugar level does not drop too quickly. As Stacey has the TPN each day (or overnight), she must have constant assessment of her blood sugar levels. (T pp 51-52). 28. Lasix is used two times daily to address the edema that Stacey experiences from her TPN infusion; one dosage in the morning and one in mid-afternoon. Stacey does not drink to hydrate her body, and thus also needs to have supplemental fluid when she is given Lasix to prevent dehydration. Tenting and other signs of dehydration require an appropriate nursing response, such as typically giving Stacey an IV bolus of 500cc’s of D5W. The bolus is equivalent in volume to two eight-ounce glasses of water that other individuals would take by mouth. (T pp 45-46). 29. Stacey has non-familial dysautonomia, which means that her autonomic nervous system does not function normally. That is, her body responses such as breathing, heart rate, and her body’s reaction to temperature changes to which it is exposed, do not function normally. These responses are automatic for persons without Stacey’s diagnosis. However, when the temperature is above 80 degrees or below 50 degrees, Stacey’s body does not react to try and regulate her body temperature. Stacey does not sweat to cool her body down when she is exposed to high temperatures. In high temperatures, Stacey’s body temperature will actually increase. In addition, she does not shiver to get warm when she is exposed to cold temperatures. (T pp 205-207). 30. Stacey also has sleep apnea. She is on a CR (cardiac respiratory) monitor, which alarms if her respirations drop below a certain level, if Stacey’s respirations stop, or if her heart rate drops below 50 or goes above 200. (T pp 212-213) As Stacey naps during the day, the monitors must be used. a) A CNA is not trained to use these monitors. ( T pp 214-215). If the monitor sounds to signal sleep apnea, the nurse responds by calling Stacey’s name, shaking her, rubbing hard on the sternum, or using an “ambo bag to start breathing for her.” ( T p 215). b) Stacey also wears a pulse oximeter that measures her oxygen level. Stacey has a portable pulse oximeter on a necklace that she can wear when she is out of bed. However, Stacey must be reminded to wear her portable pulse oximeter if she were left alone. (T pp 213-214). 31. As a result of the damage to her autonomic nervous system, Stacey also has a neurogenic bladder. This means that Stacey’s bladder does not receive a signal from her brain to contract. To empty her bladder, Stacey typically uses the Crede technique, and manually empties her bladder by pushing in and down over the bladder with her hands. If this does not work, then an in and out catherization must be used. ( T p 216-217). The evidence at hearing showed that an in and out catherization has not been used much during the past year. (Tennison, T p 360) 32. Stacey’s nurse uses multi-sticks daily to check Stacey’s urine to determine (1) whether Stacey has leukocytes in her urine (a sign of infection), (2) to determine nitrite and protein levels for checking Stacey’s liver and kidney function, and (3) to determine ketones, indicative of blood sugar 7 levels. At the time of this hearing, Stacey’s nurse was performing this check with every void. (T pp 217- 218). Reaction to color and consistency indications require intervention by a nurse. ( T p 219). 33. At the time of the hearing, Stacey’s seizures were under control with IV Phenobarbitol. (T p 209). There was no evidence that all danger of seizures was in the past. Stacey’s daily Phenobarbital cannot be put into the TPN infusion, but must be drawn and given through sterile access to the Hickman (central line). Before administering Phenobarbitol into the line, Stacey’s nurse must flush the heparin in the line with saline. Then, she slowly adds the Phenobarbital into the central line. She flushes the line with saline after the entire dose of Phenobarbitol has been given. The final step is reheparinizing the line. (Transcript I, pages 209-210). As this medication involves daily access to the central line, it could not be administered by a certified nursing assistant. 34. Essentially all medications that Stacey receives must go through her central line. Nasal medications must be watched carefully because of their effect on the autonomic nervous system. (T pp 231-232). Stacey also receives Depo-Provera and Vivelle (Estrogen), because her uterine lining is very thin. ( T p 228). a) A three day supply of antibiotics or antifungals are routinely kept in the home. Only a nurse may administer any of these. Stacey’s nurse draws blood cultures from Stacey’s line or from her arm, and faxes them to the local hospital to determine if Stacey needs antibiotics. Because some of these drugs are not stored in their mixed form, a nurse must mix them before administration. Vancomycin is the antibiotic most often prescribed. (T pp 234-235). It is given in a 750 milligram dose over a period of five hours by being infused through the Hickman catheter. (Transcript I, pages 258-259). Seven hours from the end of one dose, the next infusion is started. Stacey also requires assessment for potential reactions to Vancomycin, and requires Benadryl and Tylenol before receiving the Vancomycin, to combat any reactions to the Vancomycin. Reactions need to be addressed with extra Benadryl before Stacey “welts up.” Lasix is especially critical at such times, because of the extra liter of fluids that Stacey is receiving. (T pp 263-264). Stacey’s previous reaction to Vancomycin is called Redman’s Syndrome. During this reaction, Stacey turns bright red, and gets hives, at times all over her body. (T pp -169). b) Stacey’s doctors have also prescribed Mucomyst to provide some degree of protection for Stacey’s liver. Though Mucomyst is typically an inhalation drug, it is introduced into Stacey’s bloodstream through her central line. The Mucomyst is mixed with five per cent dextrose, and then infused over one hour using a mini infuser pump. Before the Mucomyst is given, Stacey’s line is flushed with D5 since Mucomyst is unstable when it hits saline. The line is flushed with D5 again after the Mucomyst infuses, and then flushed with saline, and thereafter with heparin. Stacey’s liver enzymes far exceed what is normal. During the infusion, Stacey’s vital signs must be monitored. (T pp 229-231). 35. Stacey’s family has emergency medications and airway equipment in the home. (T p 167). Brechelle Lashaun Pinkett, Stacey’s nurse at the time of the hearing, and Mrs. Nelson have assembled an emergency bag of supplies to take with Stacey whenever Stacey is out of her home. Items in the bag are items that would be needed to react to a break in the line or a need for another G tube. Ms. Pinkett has a back up for everything Stacey might need. (T p 463). 8 36. Stacey’s nurse is also required to draw labs that are taken to Central Carolina Hospital for testing. The results are faxed to the Nelson home. Depending on the lab results, Stacey’s nurse needs to be able to respond to situations such as what the IV bolus must have content-wise. For example, if Stacey’s potassium level is low, the fluid with potassium is used as the IV bolus. (T pp 50-51). Constant nursing assessment is required for the content and amount of the IV bolus. 37. Though Stacey can take in liquid to wet her mouth, the liquid leaves her body through her Gtube. (T p 77). The function of Stacey’s G-tube is unusual in that things come out of it into a small pouch, instead of the G-tube being a site for putting medications, feedings, etc. into Stacey’s system. (T pp 77-78). Bile and stomach contents also exit Stacey’s body through the G-tube site into the bag. If Stacey takes a bite of food simply to see what it tastes like, the food will empty into the bag. Clogging of the tube is a concern. Treatment for clogging is to take a syringe and push fluid through the button and back into Stacey’s stomach. (T pp 78-81). A certified nursing assistant could empty the bag when it is full, but could not take measures to unclog the tube. (T p 111). 38. For Stacey, the vomiting remains a concern despite having had the Nissen fundoplication surgery, because Stacey’s stomach contents have nowhere to drain except through the G-tube. If the G-tube becomes clogged and a nurse is not present to perform the unclogging procedure, Stacey’s stomach contents will be expelled through her mouth as projectile vomiting. (T pp 111-113). 39. Stacey has lung damage that came mostly from bacteremia and fungemia (bacteria and yeast in the blood) that she suffered in 2000. She had respiratory distress syndrome, for which the survival rate is ten percent, with bilateral pneumonia and a collapsed lung on the right side. The result was scarring in the bases of both lungs. (T p 201). 40. Stacey can perform some of her activities of daily living (ADLs) with prompting. (T p 396). The prompting consists of giving reminders as would be done with a younger child. In addition, there are times when Stacey cannot do any of her ADLs and needs someone else to do them. (T pp 407-408). 41. The criticality of Stacey’s needs is made more apparent by the fact that when Stacey is not doing well, labs take priority with the Cape Fear Valley Hospital in Fayetteville, and the results are faxed to the home and to all of Stacey’s doctors. (T pp 266-267). Petitioner have the home and office phone numbers, and pager numbers for Stacey’s doctors, so that they have rapid access to such doctors. (T pp 267-268). 42. According to Mrs. Nelson, Stacey has had many infections at the exit site where her central line comes out of her chest. She had not only had infections, but has had lines dislodge without warning, once when Stacey simply lifted her arms. (T p page 383). The danger of a line popping from the chest is that bleeding into the chest can occur, as can air being sucked into the bloodstream. The situation must be addressed immediately. (T pp 383-384). 9 (a) If the line is totally out, immediate pressure must be applied in the vein area where the line came out to try to stop bleeding and to keep air from entering the bloodstream. If the lines have come partly but not completely out, it must be secured so that access is not lost. The area also must be sterilized immediately to prevent bacteria from getting into the bloodstream. Reassuring Stacey is also important. (T p 384). (b) The partial popping out of a line requires that the line be held and also that the end have a sterile prep done to it. Syringes must be attached onto both ports and withdrawn to see whether there is any blood return. (T pp 386-387). 43. A CNA cannot perform any of the tasks associated with a line coming partly or completely out. They are not permitted to do so and in addition do not have sufficient training to do so. (T p 387). Being able to handle these tasks is not a matter of training on the job but is acquired through formal schooling. (T p 387). 44. Dr. Tennison is a Harvard University trained physician with board certifications in neurology, with special competence in child neurology and clinical neurophysiology. He is licensed to practice in North Carolina, Virginia, Florida, and California. He holds numerous professional memberships and has written and presented extensively in the areas of his expertise. (T pp 328-331, Pet Exh 21). 45. Dr. Tennison works with nephrology or renal consultants, pulmonary consultants, GI consultants, and a pediatric surgeon in addressing Stacey’s care. Dr. Tennison describes his role partially as that of gatekeeper in that “Stacey is so complicated, there’s no one person that has the knowledge base to be able to handle every aspect of her care.” (T p 333) Stacey has scheduled visits with Dr. Tennison every six months regarding her neurological status. During the past year, Dr. Tennison has 56 documented contacts with Stacey. In his opinion, that number of contacts in one year is “a tremendous point to document that her care is complex and substantial and continuous.” (T p 337) 46. At the administrative hearing, Dr. Tennison opined that: When I have all these highly specialized physicians involved in giving me input about what we ought to be doing with her management, and when I have a problem list that is extremely long and a list of medications that’s extremely long, you’ve got a very complicated problem. (T p 337). 47. From December 4 through 10, 2003, Stacey was hospitalized for headaches. Headaches have been a problem for Stacey intermittently for a number of years. During that time, she has received medications to treat them intravenously. Dr. Tennison described Stacey’s headaches in December 2003 as “unremitting, totally incapacitating.” (T p 324). Stacey was not in the Intensive Care Unit during her hospitalization. Dr. Tennison found that Stacey was cared for, and her needs were met on a regular hospital floor during this hospitalization. However, he determined whether Stacey’s needs were met in the hospital by talking with Stacey and 10 her family. Stacey’s mom was “right there with her the whole time. So Stacey’s mom helped take care of the situation. . . “ Tennison opined that Stacey’s condition at the time of her hospitalization, was substantially similar to her medical condition for the past six months to one year. (T p 352) 48. At the administrative hearing, Dr. Tennison recounted the difficulties with the central line regarding infection and clogging, problems requiring line replacement, and problems requiring moving the line to different sites. Line difficulties are an ongoing problem for Stacey. (T pp 325326) Dr. Tennison confirmed Stacey’s excessive daytime sleepiness and sleep apnea, hypoglycemia, chronic hematological problems with pancytopenia, chronic injury to her lungs from infection, generalized and partial seizures or partial epilepsies. In addition, Stacey has fluid, electrolyte, and nutrition issues related to the catheter and the TPN. She also has gastroesophageal reflux problems, and stress. (T pp 338-341). 49. In his professional and medical opinion, Tennison opined that none of Stacey’s conditions are going to go away or be cured, though some may go into remission and be controlled with medication. (T pp 341-343) He further opined with a reasonable degree of medical certainty that Stacey would continue to need the kind of care that she has been receiving. (T p 348). 50. While Dr. Tennison admitted that he is not familiar with the criteria for Medicaid PDN coverage, he was adamant that Stacey needed nursing care regardless of what the rules were for PDN. (T p 349). 51. When Stacey receives her TPN during the night, the nurse’s typical schedule for the next morning would include clamping off the catheter, flushing the line used for the TPN with saline, and giving Stacey her morning medications. Heparin is put into the line so the line remains open and does not clot off. Without heparin, a blood thinner, the catheter could close. (T pp 56-57). Both Helen Williams, Stacey’s former nurse, and Ms. Pinkett, Stacey’s current private duty nurse, confirmed the need for these nursing tasks, even when they were not actually responsible for the TPN infusion when it occurred overnight. 52. Ms. Helen Williams performed essentially the same duties when Stacey moved from CAP/C to PDN. (T pp 24-25). With regard to the “continuous” criteria for receiving PDN, Ms. Williams opined that a nurse providing continuous care does not mean that the nurse would be providing care every minute or even touching the person in the nurse’s care. (T pp 26-27). 53. Just because a person, such as Stacey, is considered in stable condition does not mean that the person does not need continuous care, as subtle signs about conditions must be recognized and met with a response. With Stacey, conditions may change very quickly, and require immediate reaction from a nurse. (T pp 30-31). 54. Ms. Williams opined that an untrained person might think that Stacey is just taking a nap, but in reality Stacey might not breathing. (T p 32). Having a nurse present is especially essential during the times when Stacey is not on her monitor. (T pp 32-33). 55. During the administrative hearing, Ms. Williams stressed the criticality of an immediate trained response to the alarms from Stacey’s monitors for respirations, heart rate, and oxygen 11 saturation. In her opinion, Stacey herself would not be able to respond to changes in her condition. (T pp 33-35). 56. Ms. Williams does not see Stacey being able to live independently. Stacey may know the names of her medications, but due to their complexity, she cannot administer her own medicines. (T p 36). Stacey would not know how to respond quickly to her medical needs, nor would she respond quickly. Stacey’s sensitivity to medications makes it even more critical that she have appropriate care present should she have an adverse reaction (T pp 37-38). 57. Ms. Williams also described the need for assessments that would catch non-verbal cues to pain or deterioration in Stacey’s condition. (T pp 64-65). In addition, a certified nursing assistant cannot assess a patient for pain, administering pain medication, or assess whether the medication it has worked, or determine whether more is needed. (T pp 124-125). 58. Ms Williams opined that, “CNAs do not assess. Nurses assess. CNAs give baths. They help with the activities of daily living. They makes sure they [clients/patients] clean up their room….But if any intervention had to be done, it would have to be done by the nurse or by her parent. It could not be done by them [CNAs]. They can give no medications….” (T pp 63-64). 59. In June 2002, Ms. Williams discontinued working with Stacey. (T p 20) However, Ms. Williams continues to Stacey. Ms. Williams does not think that Stacey’s medical condition now, is different from Stacey’s condition during the entire time that Ms. Williams worked with Stacey when Stacey was approved for CAP/C and for PDN. (T p 95). 60. In approximately July 2002, Brechelle Pinkett, LPN began working as Stacey’s private duty nurse. She continued to work with Stacey at the time of this hearing. When she began working with Stacey, Ms. Pinkett had no central line experience, although her employer represented that she was qualified to work with Stacey. (T pp 368-69) When asked by Petitioner’s counsel whether she had received enough training when she began to work with Stacey, Ms. Pinkett said, “Absolutely not.” (T p 431) 61. The majority of the nurse’s notes and medication administration records that Ms. Weatherman reviewed for her review were prepared by Ms. Pinkett. Ms. Pinkett acknowledged that she received no training from her employer, Provider Services of America (“PSA”), regarding writing her nursing notes, and had only a “little bit” of training in nursing school. She stated that “I’m still learning. . . and that they [the nursing notes] weren’t that great,” when she first began making her notes. “They’ve improved, because I make a conscious effort to make sure I’m documenting everything that I’m doing. . . that’s something that I know I need to do as far as my nursing license.” (T p 430) (a) Pinkett verified that the nursing notes listed at Respondent’s Exhibit 2D are her nursing notes, including her notes when she first started with Stacey. The first notes “weren’t as thorough probably as they should have been . . I’m working on that.” (T pp 453-54) She explained that: 12 I’ve always documented all my skilled nursing, but some of the skills – for instance, if I’m looking for color changes or some – I don’t know really write that down. I don’t document it because it’s – you know, you just do it. It’s done. You don’t really think to write it down. (T p 454) (b) Even though Pinkett eventually indicated that she documented treatment and interventions that she provided Stacey in her past nursing notes, she acknowledged earlier in her testimony that she omitted some of her daily assessments from her nursing notes of Respondent’s Exhibit 2D. She defined assessing as “looking for changes, any type of changes, any kind of acute changes in Stacey’s condition.” ( T pp 455-56) 62. Pinkett’s PSA supervisor, at Ms. Alicia Clark, had to counsel Brechelle Pinkett about ways to improve her notes, and had seen some improvement. (T pp 561-562). 63. Ms. Pinkett described Stacey’s care as complex, because of the way that it changes. She does not expect it to be the same every day. She constantly assesses Stacey for signs of an infections; determines whether Stacey’s central line is functioning properly; determines if the TPN, if done during the day, is infusing properly; assesses Stacey for side effects such as edema, and dehydration, checking Stacey’s urine; and assesses if Stacey’s G tube is draining correctly. Stacey’s central line can have anything go wrong with it, such as blowing, falling out, or occluding. All of these are nursing tasks that Ms. Pinkett could not perform if she were not a registered nurse. (T pp 432-433) 64. Ms. Pinkett was present when Stacey’s stitches fell out after she had her line replaced, and the cuff was showing. Ms. Pinkett had to know how to react, and “Steri Strip” the line in place to keep the wound in Stacey’s skin closed. The incident happened while Stacey was bathing. (T pp 433-434). Even though a CNA could assist Stacey with the task of bathing, a CNA would not be able to address the line issues that Stacey experienced. 65. When Ms. Pinkett arrives at the Nelson residence in the morning, Stacey is typically on her apnea monitor and pulse oximeter. The TPN infusion is complete. Ms. Pinkett accesses the central line for Lasix, and performs dressing care for the line. (T pp 435-436). She also gives Stacey medications four times daily through Stacey’s central line, plus additional medications that Stacey needs, such as antibiotics. When the TPN infusion is going to be done overnight, Ms. Pinkett sets up the TPN for infusion before she ends her shift in the afternoon. (T pp 437, 441-442). 66. At hearing, Ms. Alicia Clark reviewed entries in Respondent’s Exhibit 2F. She explained that notes indicating that PDN services were cancelled, did not reflect times when Brechelle Pinkett could not report to work because of sick child, and the family may have declined a substitute (T pp 540-543), or times when the family was away and PDN services were cancelled, because nurses do not travel on vacation with the family. Vacation from July 17 through August 4, 2003 would be an example of such travel. These entries also do not reflect times when Petitioners declined PDN services because Stacey was able to spend time with an aunt in Florida, who is a nurse and could handle the central line. In addition, there were 4 or 5 occasions during the last year when Mrs. 13 Nelson declined services, because the nurses PSA sent the home, were incapable of working with Stacey. (T pp 416-420). 67. Ms. Clark admitted that when Ms. Pinkett was unavailable to work, back-up nurses were not regularly available. (T p 547). There was likewise testimony from Mrs. Nelson and Ms. Pinkett that no other nurses actually were trained to provide PDN for Stacey. 68. Ms. Clark’s skilled nursing visit reports dated August 20, 2003 and October 15, 2003 both indicated that Stacey experienced episodes of sleep apnea. In her August 20, 2003 note, Clark specifically documented that the apnea monitor and the pulse oximeter were in use during the visit, and Stacey experienced apnea for which she required stimulation. Ms. Clark also reported that Mrs. Nelson indicated that Stacey had had apnea episodes during the night (between 12:30 and 3 a.m.) for which she required oxygen. At the time, Stacey was also having Vancomycin for two weeks, was in pain, and was experiencing increased output from her G-tube. That visit began at 4:20 pm. (T pp 416-420; 540-543; 547) 69. Ms. Clark also confirmed that the fact that Stacey might be able to ambulate, would not mean that she did not need nursing care. (T pp 552-553). 70. In preparation for the hearing, and to assure herself that Stacey’s condition had not changed so that she might qualify for PDN, Ms. Weatherman reviewed additional medical records. In total, Ms. Weatherman reviewed at least 88 days of nursing notes for the time covering January 27, 2003 October 14, 2003. Additionally she reviewed medication administration records for the months of January 2003, August 2003 and September 2003. Weatherman saw nothing in any of the additional records that changed or modified her opinion that Stacey did not meet the criteria for PDN. a) Weatherman’s comparison of PRN orders on the HCFA 485 Plan of Care and these additional nursing notes and medication administration records showed that the PRN orders, were either not ever administered during the 88 days reviewed, or were infrequently administered. These PRN orders were for: a) blood glucose, b) oxygen at two liters per minute, c) oral or nasal suctioning, d) oral or nasal suctioning, e) mist tent, f) in and out catheter, g) hospital bed elevated 30 - 45 degrees, h) hiba cleanse bath, i) various climate control interventions, j) peripheral IV access. b) Weatherman’s comparison of these additional records also showed that the following PRN meds were either, not ever administered during the 88 days reviewed, or were infrequently administered during this time period: a) Zofran, b) Epinephrine, c) Tylenol w/ Codiene, d) Ibuprofen, e) Nasalcrom, f) Toradol (occasional use noted), g) Alomide, h) Maxalt, i) Lotrimin, j) Rifampin, k)Kenalog, l) Claritin, m) cream for skin irritation, n) Narcan, o) Tobramycin, p) Clindamycin, q) Beconase, r) Cipro. 71. In Weatherman’s opinion, these additional findings corroborated Respondent’s decision to terminate Stacey’s PDN on the grounds that Stacey’s medical needs did not require a licensed registered nurse’s skilled interventions on a continuous basis, but only on an intermittent basis. 14 72. Ms. Weatherman is familiar with SNFs and the medical conditions of patients at SNFs. She is familiar with the scope and frequency of nursing needs of patients at SNFs. At the administrative hearing, Ms. Weatherman opined that the nursing interventions documented in the nursing notes and medication administration records, are consistent with the frequency and complexity of services that can be provided to a patient in a skilled nursing facility. 73. Ms. Weatherman made her decision to terminate PDN for Stacey Nelson on the basis of nine days of nursing notes. (See Resp Exh 2D, pp 54 – 69) (T page 573). 74. Ms. Weatherman agreed that a lengthy list of prn medications would not mean that they were not needed, as they might or might not be used, depending on the existence of the particular condition that they were prescribed to address. (T pp 617-618). She further agreed that though there was testimony at this hearing, of a central line blowout or occlusion, she did not see it documented in the nursing notes. (T pp 620-621). Her conclusion was based solely on the lack of documentation, something completely out of the control of Stacey and her family. 75. Ms. Weatherman admitted that her phrase, if it is not documented, then it did not happen, came from nursing school, and that the phrase does not appear in any rules. (T pp 626-627). 76. Ms. Weatherman explained that: I think that nurses have a [sic] assessing, implementing, evaluation-type phase of what we do. So we’re always assessing. That’s just innate. And then the implementation [sic] is the interventions that need to be provided, that we’re always assessing that. (T page 627). By her own testimony, Ms. Weatherman agreed that assessment is a major role for a nurse and that the implementation of the intervention is the result of the assessment. 77. Ms. Weatherman did not review any documents showing that Brechelle Pinkett worked more than sixty-one hours in a week. Her hours were typically daytime hours, and there were no overnights. (T pp 631-632). 78. Ms. Weatherman’s conclusion that Stacey’s needs were being met while the unpaid caregiver (Mrs. Nelson) was in the home, was based solely on Pinkett’s notation in her morning nursing note that Stacey was alert with her TPN infusing, and “No apparent distress noted” when she arrived at work. (T p 634) 79. Ms. Weatherman agreed that prolonged intravenous nutrition is TPN and that Stacey, therefore, meets the criteria of needing prolonged intravenous nutrition. (T p 640 and 643). 80. Home Infusion Therapy (HIT) appears to have entered the picture at the OAH Hearing in this matter. There was no testimony by any of the witnesses for either Petitioners or Respondent that HIT was ever offered to Stacey or discussed with the parents, the nurses, or with Dr. Tennison. 15 81. According to Ms. Weatherman, however, HIT “is either self-taught or the unpaid caregiver is taught the services, and …Medicaid supplies the medication and the nutrition.” (T p 641). 82. Based on the specific testimony of Mrs. Nelson at the hearing, payment by Medicaid for TPN is not available for Stacey, because she uses an out of state provider and a specialized TPN mixture that is physician-prescribed. Medicaid has been repeatedly refused coverage for the TPN. In addition, Stacey could not administer her own TPN. Her mother, the unpaid caregiver, has a disability that prevents her from being able to set up the infusion. 83. Ms. Weatherman really did not know whether the TPN could be paid for by Medicaid. She only knew that TPN could be covered by Medicaid if an out-of-state provider is also a Medicaid provider for North Carolina. (T pp 641-642). 84. Ms. Weatherman explained that a nurse for Stacey would not be available under CAP/DA, as that would not be within the budget constraints of the program. (T pp 640-641). 85. While Ms. Weatherman calculated that PDN tasks for Stacey would take only an hour and a half, she later conceded that it would not mean that a number of medications that needed to be spread out, could be safely given all together. (T p 630). Furthermore, Ms. Weatherman knew of no program under Medicaid that would provide nursing care scattered at various times of the day, with a nurse leaving and returning over and over again. She was not aware of any provider agency that would staff nurses in that matter “[b]ecause we don’t have a program that would intermittently do multiple skilled nursing visits during a day…” (T p 645). 86. According to Ms. Weatherman, CAP/DA may provide nursing visits to do such tasks as change a dressing or give an antibiotic, that is not routine. (T p 590). 87. The testimony was undisputed that Walter Nelson, Stacey’s father, is away for long periods of time in his work as a truck driver and that Stacey’s brother cannot be relied on for her care. Neither has nursing training or background. Thus, neither of these individuals is capable, willing and able to provide care. 88. The uncontroverted testimony was that Mrs. Nelson, though a nurse, is disabled and cannot work. If she cannot do nursing tasks on the job, it cannot be reasonably concluded that she can do nursing tasks in her home for her daughter. Because of the significant injury to her left hand and arm, and she is left-handed, Mrs. Nelson lacks the ability to provide the care that PDN covers. Mrs. Nelson is in constant pain, and has functional limitations that she thinks are unlikely to end. Although she is willing to help as a loving mother, and as a nurse, knows what needs to be done, Mrs. Nelson is physically unable to do it. 89. The testimony by Karen Nelson, Helen Williams, Brechelle Pinkett, and Dr. Michael Tennison establishing Stacey’s needs for continued PDN was overwhelming. 16 CONCLUSIONS OF LAW 1. The parties are properly before the Office of Administrative Hearings (“OAH”), and OAH has subject matter jurisdiction in this contested case. 2. Private duty nursing is a Medicaid covered service pursuant to the North Carolina Medicaid State Plan and 10A N.C.A.C. 22O.0122. 3. Medicaid covers only medically necessary services. 10A N.C.A.C. 22O.0105 4. 42 C.F.R. § 440.80 defines “Private duty nursing services” as: nursing services for recipients who require more individual and continuous care than is available from a visiting nurse or routinely provided by the nursing staff of the hospital or skilled nursing facility. These services are provided (a) by a registered nurse or licensed practical nurse; (b)under the direction of a recipient’s physician; and (c) to a recipient in one or more of the following locations at the option of the state – (1) his or her own home; (2) a hospital; or (3) a skilled nursing facility. 5. Medically necessary private duty nursing services are provided when they are prescribed by a physician and prior approved by the division of medical assistance or its designee. 10A NCAC 22O .0122(a) 6. “Private duty nursing services” are considered medically necessary when the person must require substantial and complex continuous nursing care by a licensed nurse. Professional judgment and a thorough evaluation of the medical complexity and psychosocial needs of the patient are involved in determining the need for PDN. The following situations represent the usual types of cases that may require PDN, though the list is not meant to be all inclusive: (1) (2) (3) Patient requires prolonged intravenous nutrition or drug therapy with needs beyond those covered by home infusion therapy services. Patient is dependent on a ventilator for prolonged periods. Patient is dependent on other device-based respiratory support, including tracheostomy care, suctioning, and oxygen support. 10A NCAC 22O .0122(c) 7. Private duty nursing services are only approvable based on the need for PDN services in the patient's private residence. an individual with a medical condition that necessitates this service normally is unable to leave the home without being accompanied by a licensed nurse and leaving the home requires considerable and taxing effort. an individual may utilize the approved hours of coverage outside of his residence during those hours when the individual's normal life activities take the patient out of the home. 10A NCAC 22O .0122(d) 17 8. Federal and State Regulations do not provide any specific definition for the terms “substantial and continuously complex.” Therefore, determinations of entitlement are made by subjective application of the rules. 9. Stacey is eligible for Medicaid services from Respondent as a recipient of SSI benefits. 10. In denying PDN services to Stacey, Respondent relies upon the Community Care Manual, Section 9.1. Section 9.1 defines PDN as “medically necessary as continuous, substantial and complex nursing services,” and then erroneously equates “nursing services” with “interventions.” In its denial of PDN for Stacey, Respondent states: The medical record documentation presented at the reconsideration review support the conclusion that the care that Stacey Nelson routinely requires is not consistent with the continuous, substantial and complex nursing services described in its Medicaid guidelines for PDN services. Certainly, Stacey requires a tremendous amount of care; however, the skilled nursing interventions that are documented are episodic, not continuous. 11. Medicaid does not pay for private duty nursing for the purpose of monitoring patients, i.e., “having a nurse with a patient ‘just in case something happens’ is not covered.” Community Care Manual, Section 9.2.2. 12. The Community Care Manual is a document prepared by the NCDHHS/Division of Medical Assistance as an interpretive guide for service providers to funded services under Medicaid law. The Community Care Manual does not have the force of law. 13. Monitoring, observation and assessment, performed by a skilled nurse, to determine the present need for active intervention, or that there is no present need for immediate intervention is a substantial and complex service. Such observation and assessment, when performed constantly throughout the time that services are provided, is substantial and complex continuous service. 14. The risk for rapid deterioration in Stacey’s condition requires constant monitoring, observation and assessment by a skilled nurse. 15. The appearance of stable health and the absence of frequent medical crises do not mean that the care required by Stacey is not substantial and continuously complex. 16. Stacey does not have to show constant skilled interventions to show that the care she requires is substantial and continuously complex. The assessment and evaluation to determine that intervention is or is not necessary, requires a skilled nurse and does constitute substantial and continuously complex care. 17. Although the occurrence of a medical emergency requiring skilled intervention may appear episodic in this case, Respondent’s reliance upon actual interventions to determine whether care needs are continuous is erroneous. 18 18. The ongoing and continued assessment, implication, and evaluation of Stacey’s medical needs and medical care requires skilled nursing care as described in 21 NCAC -36.0225, the standards of practice for a licensed practicing nurse. 19. The preponderance of the evidence at hearing showed that Stacey requires constant assessing by a registered nurse or licensed practical nurse. Stacey’s medical conditions are such that rapid deterioration is distinctly possible, which requires immediate and skilled interventions by a skilled nurse. A preponderance of the evidence at hearing showed that a certified registered nurse assistant cannot perform the constant nursing assessments and interventions that Stacey’s medical conditions require. 20. “Reporting and recording by the registered nurse are those communications required in relation to all aspects of nursing care.” Rule 21-36.0224, Nurse Practice Act. The Nurse Practice Act requires that LPN’s and RN’s accurately describe all aspects of nursing care including assessment, planning, implementation and evaluation. The preponderance of the evidence produced at hearing showed that the nursing notes Respondent relied upon to deny continued PDN coverage for Stacey were incomplete, and not an accurate picture of Stacey’s daily medical needs. Ms. Pinkett admitted that she failed to document all her daily nursing or skilled assessments of Stacey in her nursing notes. 21. Stacey’s treating physician described that Stacey has a wide array of very complicated medical issues, is surviving on total parental nutrition (“TPN”) with no appreciable oral/enteral feedings, and is in need of a private duty nurse, as she requires knowledgeable assessments and in some cases quick decisions and responses. In his letter to Respondent, Tennison specifically opined that: this child has substantial and potentially life-threatening needs and must have ongoing private duty nursing supplied in some way. Your removal of such care will expose this patient to unacceptable risk. Dr. Tennison further opined with a reasonable degree of medical certainty, that Stacey would continue to need the kind of care that she had been receiving. Dr. Tennison’s professional medical opinion in and of itself proves that Stacey’s care is substantial and continuously complex. 22. Evidence by Ms. Pinkett and Ms. Nelson proved that Stacey cannot leave home without been accompanied by a licensed nurse, that such action requires considerable and taxing efforts to leave home, and that Stacey’s required level of care satisfies the standard imposed by 10A NCAC 22O .0122(d). 23. Stacey qualifies for private duty nursing services as described in 42 CFR 440.80. 24. The possibility or fact that a person’s medical needs can be met in a skilled facility is not dispositive of the issue whether or not a person may qualify for private duty nursing. A person requiring prolonged intravenous nutrition qualifies for private duty nursing (10A NCAC 22 .0122(d)) 19 even though such a person can have his/her medical needs met in a skilled facility. A preponderance of the evidence established that Stacey required prolonged intravenous nutrition, and that her needs are beyond those covered by home infusion therapy (HIT). Ms. Weatherman’s testimony that home infusion program could provide the infusion services that Stacey needs, is not credible in light of testimony establishing that (1) Medicaid has already denied TPN coverage for Stacey, (2) Stacey cannot self-administer her own medications, and (3) Ms. Nelson is physically incapable of administering Stacey’s TPN. 25. The assessment and evaluation of Stacey is continuous. Because the types of problems being assessed and evaluated require a skilled nurse, Stacey’s monitoring, assessment, and evaluation is substantial and continuously complex. 26. Stacey meets the legal and regulatory requirements for private duty nursing services. 27. Under Medicaid rules, Stacey is entitled to services that are deemed medically necessary. DECISION Based upon the foregoing Findings Of Fact and Conclusions Of Law, the undersigned hereby determines that Respondent’s denial of private duty nursing services for Petitioner should be REVERSED. Respondent should continue to provide private duty nursing services for 15 hours per day for three days a week, and 8 hours per day for two days a week. ORDER AND NOTICE The North Carolina Health and Human Services, Division of Medical Assistance, will make the Final Decision in this contested case. N.C.G.S. § 150B-36(b), (b1), (b2), and (b3) enumerate the standard of review and procedures the agency must follow in making its Final Decision, and adopting and/or not adopting the Findings of Fact and Decision of the Administrative Law Judge. Pursuant to N.C.G.S. § 150B-36(a), before the agency makes a Final Decision in this case, it is required to give each party an opportunity to file exceptions to this decision, and to present written arguments to those in the agency who will make the Final Decision. N.C.G.S. § 150B-36(b)(3) requires the agency to serve a copy of its Final Decision on each party, and furnish a copy of its Final Decision to each party’s attorney of record and to the Office of Administrative Hearings, 6714 Mail Service Center, Raleigh, N.C. 27699-6714. This the 18th day of May, 2004. ____________________________ Melissa Owens Lassiter Administrative Law Judge 20