The Issue The issue in this case is whether Petitioner must reimburse Respondent for overpayments totaling $2,851.19 which Petitioner received from the Florida Medicaid Program during the period May 24, 1999 through January 26, 2001.
Findings Of Fact Respondent, the Agency for Health Care Administration (hereinafter referred to as the "Agency"), is an agency of the State of Florida. The Agency is responsible for administering the Florida Medicaid Program. See Chapter 409, Florida Statutes. Among other responsibilities, the Agency is authorized "to recover overpayments . . . as appropriate . . . ." Section 409.913, Florida Statutes. Petitioner, Meji, Inc., d/b/a 7th Avenue Pharmacy (hereinafter referred to as "Meji"), was, at all times pertinent to this case, a duly authorized Medicaid provider, having entered into a Medicaid Provider Agreement with the Agency. Meji was assigned Medicaid Provider Number 0165076-00. Meji is also a licensed pharmacy in Florida, having been issued license number PH0016158. As a Medicaid provider, Meji is authorized to dispense drugs and supplies to Medicaid recipients, for which Meji is entitled to reimbursement from the Medicaid Program. In return, Meji has agreed to comply with all governing statutes, rules, and policies, including policies set forth in the Florida Medicaid Prescribed Drug Services Coverage Limitations and Reimbursement Handbook, incorporated by reference into Rule 59G- 4.250(2), Florida Administrative Code. On March 20, 2001, an audit was performed of payments from the Medicaid Program to Meji. On January 24, 2002, a Provisional Agency Audit Report was issued finding that Meji had received $40,062.52 in overpayments from the Medicaid Program and offering Meji an opportunity to respond to the Agency's provisional determination. When Meji failed to respond to the Provisional Agency Audit Report, the Agency issued a Final Agency Audit Report informing Meji that the Agency intended to seek reimbursement of the $40,062.52 in overpayments Meji had received for services provided during the period May 24, 1999 through January 26, 2001. The Final Agency Audit Report was issued March 8, 2002. Meji requested a hearing to contest the Agency's determination and provided documentation not previously provided to the Agency. On March 19, 2003, after reviewing the newly provided documentation, the Agency issued an Amended Final Agency Audit Report in which the Agency informed Meji that it had received overpayments of $2,851.19. In response to this notice, Meji requested a formal administrative hearing by letter dated March 20, 2003. The amount of the overpayments which the Agency seeks to recoup in this proceeding was determined by taking a statistically valid random sample of Meji's submitted Medicaid claims submitted during the audit period. The amount of the overpayments found in the random sample was then extended to the total of Meji's claims for the audit period based upon generally accepted statistical formulas and methods. By failing to respond to the Agency's Request for Admissions, Meji is deemed to have admitted the validity of the statistical formula utilized by the Agency. The Amended Final Agency Audit Report, along with the supporting work papers, were offered and accepted in evidence in this case. The Amended Final Agency Audit Report, in an attached Pharmacy Audit-Final Report, sets out the manner in which the overpayments were calculated. Those calculations are further described in proposed finding of fact P.(1) through (6) of the Respondent's Proposed Recommended Order and Incorporated Closing Argument. Those findings are hereby accepted and incorporated into this Recommended Order by reference. The Amended Final Agency Audit Report and supporting work papers admitted in evidence in this case show that Meji received overpayments in the amount of $2,851.19. No evidence to the contrary was offered by Meji. The Agency incurred costs during the investigation of this matter. The amount of those costs was not known at the time the final hearing was conducted.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency enter a final order requiring Meji's to repay the Agency the principal amount of $2,851.19 plus interest as provided in Section 409.913, Florida Statutes. DONE AND ENTERED this 15th day of July, 2003, in Tallahassee, Leon County, Florida. S LARRY J. SARTIN 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 15th day of July, 2003. COPIES FURNISHED: Debora A. Fridie, Esquire Agency for Health Care Administration 2727 Mahan Drive, Suite 3431 Fort Knox Building III Mail Station 3 Tallahassee, Florida 32308 Sola Gafaru, President Meji, Inc. 14812 Northwest 7th Avenue Miami, Florida 33168 Rhonda M. Medows, M.D., Secretary Agency for Health Care Administration 2727 Mahan Drive, Suite 3116 Fort Knox Building III Tallahassee, Florida 32308 Valda Clark Christian, General Counsel Agency for Health Care Administration 2727 Mahan Drive, Suite 3431 Fort Knox Building III Tallahassee, Florida 32308 Lealand McCharen, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Station 3 Fort Knox Building III Tallahassee, Florida 32308
The Issue The issue to be decided is the amount to be paid by Petitioner to Respondent, Agency for Health Care Administration (Agency), out of her settlement proceeds as reimbursement for past Medicaid expenditures pursuant to section 409.910, Florida Statutes (2018).
Findings Of Fact On April 21, 2011, Ms. Puzanskas gave birth to her son. After birth, Ms. Puzanskas began experiencing symptoms of nervousness, panic attacks, and being overwhelmed. On June 21, 2011, she called her doctor's office and described her symptoms to her midwife. Her midwife concluded that Ms. Puzanskas was depressed or experiencing "baby blues." Based on this telephonic diagnosis, the midwife arranged for a prescription of the anti-depressant psychotropic drug, Zoloft, to be called into Ms. Puzanskas' pharmacy. The next day after taking the Zoloft, Ms. Puzanskas again called her doctor's office with complaints that the Zoloft was causing her to feel strange and jittery. Ms. Puzanskas was instructed to continue taking the medication. On June 24, 2011, Ms. Puzanskas began suffering from severe depression and hallucinations. That same day, she went into her back yard and doused herself with gasoline and set herself on fire. She suffered third-degree full thickness burns over 30 percent of her body requiring multiple skin grafts, with scarring over 60 percent of her body from all burns and grafts. Ms. Puzanskas' medical care for the injuries was paid by Medicaid, which provided $54,171.70 in benefits associated with her injuries. This amount constituted her entire claim for past medical expenses. As a condition of her eligibility for Medicaid, Ms. Puzanskas assigned to the Agency her right to recover from liable third-party medical expenses paid by Medicaid. Ms. Puzanskas brought a medical malpractice action against the medical staff responsible for her care to recover all of her damages associated with her injuries. During the pendency of the lawsuit, the Agency was notified of the action. Although it did not dispute the ultimate settlement received by Petitioner or otherwise participate in any aspect of the litigation, the Agency asserted a $54,171.70 Medicaid lien against Ms. Puzanskas' cause of action and settlement of the action. In preparation for the trial, Petitioner's counsel used mock jury panels to evaluate their trial strategies, value of damages, and the likelihood of a defense verdict. Mock jurors split. Some would have returned a verdict for the defense, finding no liability, while others would have returned a verdict for Ms. Puzanskas and given her some limited damages. Still others would have given her a very high amount of damages. See Pet'r Ex. 9. Eleven mock jurors provided verdicts from approximately $16,554,000 down to approximately $554,000. The remaining six jurors would have returned zero-dollar verdicts. The average award in the 17 verdicts was $3,741,000. Nine of the 11 jurors who produced a verdict for Petitioner included approximately $54,000 in their verdict, and then added amounts ranging from $500,000 to $16,500,000. The $54,000 is representative of Petitioner's rounded hospital bills. The insurance policy covering the incident had limits of $250,000 and the medical providers had no collectable assets. After the first day of trial, the medical providers offered $500,000 to settle the case, and this was accepted. However, this amount did not fully compensate Petitioner for her injuries. Mr. Moore, an experienced trial attorney who represented Petitioner, testified that based on his training and experience, Petitioner's damages had a value in excess of $3,700,000. However, using a conservative number for purposes of this case, he valued her damages at $3,000,000. Thus, the $500,000 settlement represented a recovery of 16.6 percent of the value of her damages, and a similar percentage for past medical expenses. Therefore, he testified that an allocation of $8,992.50, or 16.6 percent of $54,171.70, would be a reasonable and conservative portion of the settlement for past medical expenses. Based on his training and experience and review of the medical records and file, Mr. Barrett, a trial attorney, valued Petitioner's damages between three and five million dollars. He also opined that $3,000,000 would be a very conservative figure. Using the same allocation method advocated by trial counsel, Mr. Barrett applied a 16.6 percent ratio to the Medicaid expenses, and concluded that an allocation of $8,992.50 of the settlement to past medical expenses is reasonable, rational, and appropriate. This testimony was not rebutted by the Agency, and the Agency did not present any evidence proposing a differing valuation of damages or contest the methodology used to calculate the $8,992.50 allocation to past medical expenses. The testimony from Mr. Moore and Mr. Barrett is compelling and persuasive. Accordingly, the undersigned finds that Petitioner has proven by a preponderance of the evidence that $8,992.50 of the settlement represents reimbursement for past medical expenses.
The Issue Whether Medicaid overpayments were made to Petitioners, Jeanette E. Norris, M.D., and Sandcastle Pediatrics, and, if so, what is the total amount of these overpayments.
Findings Of Fact The Agency is the state agency charged with administration of the Medicaid program in Florida under Section 409.907, Florida Statutes. Petitioner Norris is a physician who, during the period of January 1, 1997, through October 16, 1999, provided Medicaid services to Medicaid beneficiaries pursuant to a valid Medicaid provider agreement with the Agency under provider number 0543756-00. Petitioner Norris at all times relevant to this matter, provided Medicaid services in an office owned by Petitioner Norris, doing business as Sandcastle Pediatrics, but all Medicaid claims were claimed by and paid to Petitioner. The Agency performed an audit of paid Medicaid claims for services claimed to have been performed by Petitioner Norris during the period January 1, 1997, through October 16, 1999. On March 12, 2201, the Agency issued a Final Agency Audit Report ("Audit Report" or "FAAR"), requesting Petitioner Norris to reimburse the Agency $39,534.32, alleged for overpayments of Medicaid claims submitted by and paid to Petitioner Norris. The determination of overpayment was based upon audit findings that services provided by Petitioner Norris did not meet Medicaid criteria. These criteria included: lack of documentation of services rendered; lack of documentation to support the higher level of service billed; failure to document the required elements for early periodic screening for diagnosis; failure to document performance of treatment services; and billing for two codes when one code incorporated the elements of the other code. During the Audit period, the applicable statutes, laws, rules and policy guidelines (Medicaid rules) in effect required Petitioner Norris to maintain all Medicaid-related records and information that supported any and all Medicaid invoices or claims made by Petitioner Norris during the Audit period. During the Audit period, the Medicaid rules required Petitioner Norris to provide the Agency or the Agency's authorized representatives all the Medicaid-related records and other information that supported all the Medicaid-related invoices or claims for which Petitioner Norris billed Medicaid during the Audit period. Petitioner Norris was required to maintain all medical and Medicaid-related records for a period of five years to satisfy all necessary inquiries by the Agency. During all times relevant to this matter, Petitioner Norris had an affirmative duty to assure that each claim presented to the Agency was true and accurate, and that goods and services were provided in accord with applicable provisions of the Medicaid rules. Medicaid goods and services are deemed excessive or medically unnecessary unless both the medical basis and specific need for them are fully and properly documented in the recipient's medical record. At the request of Ms. Lynne Edwards, the Agency's auditor, the Agency generated a random list of 24 Medicaid recipients (cluster sample) rendered services by Petitioner Norris during the audit period. In addition, the Agency generated work papers of: the total number of recipients to whom Petitioner Norris rendered services during the audit period; the total number of claims by Petitioner Norris with dates of service during the audit period; the total amount paid to Petitioner Norris for all claims with dates of service during the audit period; and worksheets representing each recipient's claims for the audit period. Ms. Edwards obtained the work papers generated by the Agency concerning the random cluster sample, provided 24-hour advance notice to Petitioner Norris of an on-site visit, and performed an on-site visit at the office where Petitioner Norris provided medical services and maintained patient records. After the on-site visit, Ms. Edwards prepared an on-site investigative summary. When Ms. Edwards performed the on-site visit, she spoke with Petitioner Norris. Ms. Edwards presented Petitioner Norris with a questionnaire and printout of the names of the 24 patients in the cluster sample, and asked Petitioner Norris to fill out the questionnaire and mail back to Ms. Edwards the completed questionnaire along with copies of the medical records of the 24 patients in the cluster sample. Ms. Edwards also asked to see medical records of a few of the patients in the cluster sample while she was on-site. Petitioner Norris did not mail a completed questionnaire to Ms. Edwards. Subsequent to the on-site visit, Petitioner Norris provided the Agency with medical records for five of the 24 recipients in the sample. The records were given to Ms. Blanca Notman, the Agency's registered nurse consultant, for policy compliance review. Thereafter, Petitioner Norris submitted medical records for an additional five recipients in the sample. Ms. Edwards forwarded the additional medical records to Ms. Notman for review. After Ms. Notman reviewed the medical records and provided her comments on the claims worksheets, Ms. Notman forwarded the records and worksheets to Dr. Larry Deeb, a pediatrician physician consultant, for a review relating to medical necessity and level of care issues. After review and comments by Dr. Deeb, the records and worksheets were returned to Ms. Notman, who calculated adjustments on the claims worksheets based on the opinions of Dr. Deeb. Ms. Notman returned the medical records and worksheets to Ms. Edwards, along with a Professional Medical Review Report signed by Ms. Notman and Dr. Deeb. Ms. Edwards received the medical records, worksheets, and the Professional Medical Review Report, totaled the overpayments per patient/cluster in the sample, and arrived at a figure of $3,298.45 as the total overpayment for all cluster sample claims. Ms. Edwards submitted the cluster sampling information and the audit review results to another Agency employee for the generation of the extrapolated overpayment calculation, using the Agency's formula. The Agency employee generated and provided to Ms. Edwards the overpayment calculation that represented the findings of the audit of the cluster sampling extrapolated to the total paid claims in the audit period, which was $39,534.32. The Agency prepared its February 6, 2001, Preliminary Agency Audit Report (PAAR) based on the audit review of the medical records provided by Petitioner Norris for the paid claims in the cluster sample. Petitioner Norris provided no documentation for 14 of the 24 patients in the cluster sample, and the audit took this into account. The PAAR was mailed to Petitioner Norris. The PAAR identified all policy violations and determinations found in the audit review. Petitioner Norris closed her medical practice in March 2001. Petitioner Norris joined the employees of a group that provides physicians to hospitals on contract for limited periods of time. This required Petitioner Norris to be away from home and unavailable for large periods of time, which complicated all aspects of this case. The PAAR informed Petitioner Norris that the findings were preliminary and encouraged Petitioner Norris to submit any additional documentation she felt would serve to reduce the overpayment within 30 days. Petitioner Norris did not submit additional documentation to the Agency. Pursuant to Section 409.9131, Florida Statutes (2000 Supp.), the Agency prepared and mailed to Petitioner Norris its March 12, 2001, Final Agency Audit Report (FAAR), asserting a total overpayment determination of $39,534.32 and again identifying all policy violations and determinations found in the audit review. After receipt of the FAAR, Petitioner Norris requested an informal hearing, which the Agency received on April 13, 2001. In her hearing request Petitioner Norris said the 30 days given between the PAAR and FAAR for the submission of additional documentation was not sufficient because she was in the process of closing her medical office and relocating her files and medical records. Petitioner Norris requested an additional 60 days for the submission of additional information, and the letter inferred there were disputed issues of material fact. On April 26, 2001, the Agency's clerk submitted a request to Petitioner Norris that she clarify her hearing request, given what appeared to be disputed issues of material fact. On September 12, 2001, Petitioner Norris sent the Agency a letter that informed the Informal Hearing Officer of dates of availability and acknowledged there were disputed issues of material fact. The matter was subsequently referred to the Division of Administrative Hearings. On March 28, 2002, the Agency took the deposition of Dr. Deeb in lieu of live trial testimony. Prior to the commencement of the deposition, the determination of the Agency as to the paid claims in the cluster sample was reviewed by the parties and stipulations were entered into between the Agency and Petitioner Norris. The stipulations were restated during the deposition. Based on the stipulations prior to and during the deposition of Dr. Deeb, the Agency re-calculated the total overpayment for the paid claims in the cluster sample, extrapolated the sample findings to the population, and determined the adjusted total overpayment of paid Medicaid claims. Prior to the commencement of the final hearing on April 1, 2002, the parties agreed that the information set forth in AHCA Exhibit 10A represented the Agency's final determination as to the claims in the cluster sample determined to be overpayments by the Agency, with the exception of the "No Documentation" overpayment for the date of service of March 3, 1997, which the parties agreed should not be listed on the exhibit because the Agency represented that it would recalculate the extrapolated total overpayment, based upon the final determinations set forth in the Agency Exhibit 10A (subtracting out the "No Documentation" March 3, 1997 listing), and the parties were permitted to supplement AHCA Exhibit 30 with any updated total overpayment determination. The Agency recalculated the extrapolated total overpayment after April 1, 2002, which was determined to be $4,000.48, and supplemented AHCA Exhibit 30 by filing AHCA Exhibit 30A on June 7, 2002. On April 1, 2002, when the final hearing commenced, the parties agreed that the only Medicaid claims overpayment determinations made by the Agency concerning the audit of the claims in the cluster sample that were in dispute were the following: Blood count/fingerstick hemoglobin and hemocrit tests performed as a part of a physician office visits as follows: Recipient/ Patient Date of Service Procedure Billed Reason for Claim Denial Overpayment 13 3/25/97 Blood Count/HE Part of OV $ 2.00 14 2/24/97 Blood Count/HE Part of OV $ 2.00 14 3/10/97 Blood Count/HE Part of OV $ 2.00 16 4/4/98 Blood Count/HE Part of OV $ 2.00 16 5/12/98 Blood Count/HE Part of OV $ 2.00 16 6/18/98 Blood Count/HE Part of OV $ 2.00 Office visit (OV) cannot be billed the same day that an EPSDT is billed, when patient only seen once that day: Recipient/ Patient Date of Service Procedure Billed Reason for Claim Denial Overpayment 22 7/29/97 OV-99202 OV billed same $31.35 same day as EPSDT On April 1, 2002, when the final hearing commenced, the parties agreed that the following claims overpayment determinations made by the Agency concerning the audit of the claims in the cluster sample were not in dispute: Claims were no medical records existed to indicate services were performed: Recipient/ Patient Date of Service Procedure Billed Reason for Claim Denial Overpayment 3 5/12/97 EPSDT No Med. Rec. $64.98 3 5/12/97 blood count No Med. Rec. $ 2.00 3 5/12/97 immunization No Med. Rec. $10.00 3 5/12/97 immunization No Med. Rec. $10.00 3 5/12/97 immunization No Med. Rec. $10.00 3 8/27/97 immunization No Med. Rec. $10.00 3 8/27/97 immunization No Med. Rec. $10.00 3 8/27/97 immunization No Med. Rec. $10.00 3 8/27/97 immunization No Med. Rec. $10.00 7 7/30/97 OV-99213 No Med. Rec. $25.00 22 7/14/98 EPSDT No Med. Rec. $65.33 Office visit (OV) claims, to include Early and Periodic Screening, Diagnosis, and Treatment Services claims (EPSDTs), that lacked all EPSDT components, adjusted to appropriate level of care OV claims. Recipient/ Date of Adjustment Reason for Patient Service Made Adjustment Overpayment 3 8/27/97 EPSDT to 99214 OV Lacked components $27.72 3 8/27/98 99205 OV to 99204 OV Level of Service $38.18 9 10/17/97 99205 OV to 99204 OV Level of Service $17.04 10 4/3/97 99204 OV to 99203 OV Level of Service $21.36 14 3/24/97 99214 OV to 99213 OV Level of Service $12.26 14 4/28/97 99214 OV to 99213 OV Level of Service $12.26 16 1/20/97 99205 OV to 99204 OV Level of Service $17.04 16 3/5/97 99214 OV to 99213 OV Level of Service $12.26 19 3/11/97 99205 OV to 99204 OV Level of Service $17.04 20 4/2/97 99214 OV to 99213 OV Level of Service $12.26 21 2/13/98 99205 OV to 99204 OV Level of Service $16.77 23 8/4/97 99204 OV to 99203 OV Level of Service $21.36 As to the disputed claims concerning the blood count/fingerstick hemoglobin and hemocrit test performed as a part of a physician office visit, Petitioner Norris testified that she did not see the test as a routine part of an office visit, she disagreed with the policy that the test could not be billed separately, and she indicated that usually her nurse would perform the test, which she agreed involved a little prick of blood run through something and took about five minutes. The preponderance of the evidence established that the Agency's determination as to these disputed claims was correct--the Medicaid Handbooks in effect during the audit prohibited Petitioner Norris from separately billing for these tests because they were done during an office visit. The one disputed claim concerning an EPSDT and office visit billed on the same day when the patient was only seen once was for the treatment of the patient's oral infection (thrush). Petitioner Norris admitted that she received reimbursement for office visit procedure Code 99202, in addition to being reimbursed for an EPSDT, even though the patient was seen only once on that day. It was undisputed that prior to the issuance of the Agency's audit report, a peer review was performed by Dr. Larry C. Deeb, a pediatrician in active practice pursuant to Section 409.9131, Florida Statutes (2000 Supp.) Based on the documentation that Petitioner Norris provided to the Agency before the issuance of the Agency audit report, the Agency audit report and related work papers, the adjustment made because of stipulations between the parties after the Agency Audit Report was issued, a preponderance of the evidence establishes there is a Medicaid claims overpayment of $4,000.48 to Petitioner Norris for paid Medicaid claims for the audit period. On April 1, 2002, at the final hearing, Petitioner Norris announced that she disputed the appropriateness of the Agency's statistical formula regarding the extrapolation of the Agency's audit findings concerning the paid claims in the cluster sample to the universe/population of all paid claims during the audit period. The Agency objected on numerous grounds, all of which were overruled. The Agency was permitted to present rebuttal testimony at the conclusion of the presentation of evidence by Petitioner Norris, which the Agency did on June 3, 2002. The statistical formula utilized by the Agency when it made findings based on the cluster sample audit and applied to extrapolate those findings to the population of patient claims paid during the audit period is found on page two of the agency audit report. It was undisputed that during the audit period, Petitioner Norris saw 305 Medicaid patients and had a total of 3,035 Medicaid claims paid. It also was undisputed that a random sample of 24 Medicaid patients who were provided services by Petitioner Norris during the audit period was selected by the Agency for this audit, and all Medicaid paid claims during the audit period for each of the 24 randomly selected patients were reviewed in this audit. Petitioner Norris presented the expert testimony of Dr. Ibrahim Ahmad, regarding the Agency's challenged formula.1 The formula used by the Agency is the one used for infinite populations. In this case, the audited cases were a sample of a finite population. This builds an error into the calculation which can only be corrected by testing the sample against the population to determine if it is reflective of the population. Dr. Ahmad observed that this "proofing" had not been done and in the absence of such a proof of the sample he could not deem the results accurate. The Agency presented the expert testimony of Dr. Mark Johnson on the statistics issue.2 Dr. Johnson explained that there is an adjustment term in the challenged formula--"U" minus "N" under the square root--that adjusts the challenged formula for finite populations.3 In addition to reviewing the Agency's final audit report letter and Agency materials related to the generation of the sample in this case, Dr. Johnson conducted his own analysis of the data, using an Excel spreadsheet program and a statistical package. He was able to reproduce, independently, the same numerical results as the Agency--the estimated overpayment, variance estimates, and the lower 95 percent confidence interval limit. In this case, Dr. Johnson determined the sample was representative of the population because, looking at some of their summary values, they were consistent with the population as a whole. Dr. Johnson indicated that by using the Agency's formula, he arrived at the same calculated values as the Agency. He also investigated assumptions underlying the procedures used in the analysis of this cluster sampling design. Dr. Johnson reviewed the random distribution of the 24 clusters, compared the dollar per claim values in the sample with the figures for the population, and compared the number of claims per patient in the sample with the number of claims per patient in the population. Dr. Johnson's investigation of these properties of the random sample in comparison to the properties of the whole population led him to the conclusion that the sample was representative of the population in this case. The Agency's statistical formula adjusts the "best guess" estimate the total Medicaid overpayment ($7,803.10) downward based on the lower end of the 95 percent confidence interval, causing the overpayment being sought by the Agency to be 4,000.48. The confidence interval is plus or minus the estimate--in this case, the 95 percent confidence interval is $4,000.48 to $11,605.62 (i.e., $7,803.10 plus or minus $3,802.62). Statistically, there is 95 percent confidence that the true overpayment lies within this interval, and the Agency, by seeking the overpayment at the low end of the confidence interval, is giving Petitioner Norris the entire benefit of all of the uncertainty associated with the sampling process. Prior to the commencement of the final hearing in this cause, the Agency had filed its notice of intent to seek investigative costs, expert witness costs, and attorney's fees. At the final hearing, it was determined, as a matter of record, that jurisdiction would be retained for the determination of the Agency's request for such costs and fees. The procedural record of the case reveals that this case was forwarded to DOAH precipitously and before the Petitioner Norris would informally present information which reduced the claim from almost $40,000 to $4,000. At the commencement of the hearing, the parties stipulated to most of the operative facts. The statistical formula was a real issue, and in sum, Petitioner Norris was right; the formula reported was inappropriate. The Agency showed it did not use the reported formula, but one that adjusted for a finite population. Further, the testimony of Petitioner Norris' expert witness was not that the amount of alleged overpayment was wrong, but that the formula was not appropriate. The Agency's expert testified that a factor not stated in the letter was used to adjust the challenged formula for a finite population. Further, the Agency's expert testified he normed the stratified sample against the sampled population, and it did represent that population. This was one of the approaches Dr. Ahmad had suggested to validate the process when using the stated formula. However, Dr. Johnson did this after the challenge, not before. In sum, the burden was on the Agency to prove its case, and by failing to adopt its formula by rule, the Agency placed itself in the position of proving the formula's appropriateness at every hearing. It is so in this case. The request for costs and fees is denied.
Recommendation Based on the foregoing Findings of Facts and Conclusions of Law, it is RECOMMENDED: That the Agency for Health Care Administration issue a final order requiring Petitioner Norris to reimburse the Agency for Medicaid overpayments in the total amount of $4,000.48, plus such interest as may statutorily accrue. For the reasons found above, the Agency's motion for investigative costs, expert witness fees, and attorney's fees is denied. DONE AND ENTERED this 28th day of February, 2003, in Tallahassee, Leon County, Florida. STEPHEN F. DEAN 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 28th day of February, 2003.
The Issue Whether the Agency for Health Care Administration (Agency or Petitioner) is entitled to recover from Ideal Pugh, Sr., d/b/a Services on Time, LLC (Respondent), alleged Medicaid overpayments, administrative fines, and investigative, legal, and expert witness costs.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner, Agency for Health Care Administration, enter a final order requiring Respondent, Ideal Pugh, Sr., d/b/a Services on Time, LLC: To repay the sum of $563,073.76, for overpayments on claims that did not comply with the requirements of Medicaid laws, rules, and provider handbooks; To pay interest on the sum of $563,073.76 at the rate of ten percent per annum from the date of the overpayment determination; To pay a fine of $1,000 for failure to furnish all Medicaid-related records within the requested timeframe; To pay a fine of $1,500 for violations of the requirements of Medicaid laws, rules, and provider handbooks; and To pay allowable costs pursuant to subsection 409.913(23)(a), Florida Statutes. If a disputed issue of material fact arises regarding the appropriate amount of those costs, the matter may be referred back to DOAH for a further recommendation regarding costs. DONE AND ENTERED this 31st day of May, 2012, in Tallahassee, Leon County, Florida. S JAMES H. PETERSON, III 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 31st day of May, 2012.
Findings Of Fact At all times pertinent to this hearing, Respondent, M. J. Warhola, was a doctor of osteopathic medicine and properly licensed as such by the State of Florida by license number OS 0001256, issued in 1957. He has been practicing osteopathic medicine at his present location in Tampa, Florida, for the past 17 or 18 years. Respondent first started treating Pearl O. Knowles in 1965. Generally, she was suffering from severe diabetes and was overweight. He also, over the years, treated her for arteriosclerosis. Among the drugs he was prescribing for her during the 1979-1989 time period were Placidyl (sleeping pill), Verstran (tranquilizer), Triavil (antidepressant), Dilantin (anticonvulsant) Teldrin (antiallergenic), Donnatal (sedative), Synalgos (painkiller), Talwin (painkiller), various antibiotics, and such other substances as insulin, stool hardeners, vitamins, diuretics, antihistamines, and antiemetics. During the period from January, 1979, through December, 1981, prescriptions written by Respondent for these varying medications for Mrs. Knowles or her husband were filled by area pharmacies in accordance with the following chart: MONTH/YR TOTAL MRS. K MONTH/YR TOTAL MRS. K Jan. 79 11 4 July 80 22 15 Feb. 79 15 7 Aug. 80 15 10 Mar. 79 10 5 Sept.80 26 19 Apr. 79 14 11 Oct. 80 20 10 May 79 13 10 Nov. 80 21 16 June 79 10 8 Dec. 80 22 17 July 79 11 6 Jan. 81 16 11 Aug. 79 15 10 Feb. 81 15 12 Sept.79 13 10 Mar. 81 25 17 Oct. 79 15 6 Apr. 81 26 17 Nov. 79 7 5 May 81 21 10 Dec. 79 17 12 June 81 11 4 Jan. 80 12 8 July 81 23 8 Feb. 80 17 12 Aug. 81 25 23 Mar. 80 21 17 Sept.81 5 5 Apr. 80 17 14 Oct. 81 20 14 May 80 24 22 Nov. 81 4 2 June 80 27 21 Dec. 81 2 2 TOTAL: 588 400 Many of the above instances are refills of the same prescription. According to Respondent, some prescriptions were authorized five refills without contact with him. Some, such as Prescription #27162 for 100 Triavil, initially filled on December 1, 1979, was subsequently refilled at least 11 times, and three other separate prescriptions for the same drug were filled multiple times. From January, 1979, through September, 1980, a period of 20 months, 30 tablets each prescriptions for Placidyl tablets, written by Respondent for Mrs. Knowles, were filled 46 times for a total of 1,380 tablets. During the same period, Triavil prescriptions for 100 capsules each written by Respondent for Mrs. Knowles were filled 22 times for 3,200 tablets, Talwin at 100 tablets 13 times for 1,300 tablets, at least 10 prescriptions for either Tylenol #3 or Fiorinol #3, both with codeine, at 50 tablets each for the Fiorinol at least totalling more than 509 tablets, as well as all the others stated in paragraph 2 above. Mrs. Knowles admits taking too much medication, but claims it is not the fault of Respondent. Whenever Respondent saw her and gave her a prescription for any medicine, he would tell her what dosage to take. She would see the Respondent every two or three weeks and get a new prescription each time and would also give her prescriptions at her request without her going to the office personally. Regardless of what instructions Respondent would give her concerning the dosage of the various painkillers and "nerve medicines" he would give her, she often exceeded the directed dose either by accident or in an effort to relieve the extreme pain she was experiencing in her hands and feet. Not only did she get drug prescriptions from Respondent, but by her own admission, she also saw other doctors during the period from whom she got "pain pills," as well as taking those given to her on her release from the hospitals to which she was admitted. She recognized that she was taking too many drugs at the time, but the pain was severe and she felt it was required. During this same period of time, from mid-1979 on through early 1982, while Mrs. Knowles was seeing Respondent for her diabetes and other chronic ailments, she was admitted to several hospitals in the area. On June 11, 1979, she was admitted to the Brandon Community Hospital (BCH) in Brandon, Florida (Brandon is a small community east of Tampa), in a confused and disoriented state. The admission diagnosis was diabetes with electrolyte imbalance. The attending physician noted at the time that the patient "is somewhat dependent on drugs." Approximately two months later, on August 15, 1979, Mrs. Knowles was again admitted to BCH, this time for uncontrolled diabetes and overdosing her drugs including Placidyl and Fiorinol. Again, the attending physician noted the failure of the patient to take care of her diabetes, her drinking, and her drug dependency. Mrs. Knowles thereafter stayed out of the hospital for about a year until, on September 1, 1981, she was again admitted to BCH, again for her diabetes. Secondary diagnoses on this occasion were hypertension and taxciencephalopathy, a disorder of brain function. At this time, she was seen in the hospital by Dr. Mark Stern. Based on the lab work performed and examination by Dr. Stern and other specialists to whom she was referred, it was concluded that her condition, aside from the diabetes and hypertension, was related to her overuse of drugs such as Talwin, Valium, Triavil, and the like. She was again seen by Dr. Stern at BCH on October 24, 1981, when she was admitted for an unintentional drug overdose. A drug screen done at the time of admission revealed a Placidyl level of 69.4 (normal level is 0.5 to 10, with toxic levels being greater than 20). A repeat test six and a half hours later showed the level of Placidyl at 62.4. Other lab tests showed opiates, benzodiazepan (tranquilizers such as Valium and Librium), and salecylates. When she was admitted on this occasion, she had with her a box containing several medicine bottles. Notwithstanding Petitioner's allegation that "Said labels were not labeled by Respondent," the testimony of Deborah Ann Brown, Director of Pharmacy at BCH, to whom the box of bottles was given for identification, shows that only one of all the bottles did not have the appropriate markings on it. It also appears that some of the medicines in the box had been prescribed for Mrs. Knowles' husband, Ira. Dr. Stern again saw Mrs. Knowles when she was brought to BCH on January 6, 1982, complaining of weakness and difficulty in walking. Again, her history showed she was taking antidepressants and Placidyl for chronic insomnia. Dr. Stern recalls that Mrs. Knowles telephoned him on October 9, 1981, and requested prescriptions for Placidyl, Triavil, and Talwin, but he refused to prescribe them for her. He terminated his relationship with her in August, 1982. During the period she was his patient, however, he did prescribe for her such substances as painkillers, sleeping pills, and antianxiety drugs, the same generic types of drugs as prescribed by Respondent, by written prescriptions, some of which called for multiple refills. Though Mrs. Knowles advised Dr. Stern that she was being treated by Dr. Warhola, Dr. Stern did not discuss her with Dr. Warhola or even contact him. Even when Mrs. Knowles threatened to get drugs from Respondent when Dr. Stern refused to give her prescription over the phone in October, 1981, Dr. Stern still did not contact Dr. Warhola. Between the fourth and fifth BCH hospitalizations, on December 21, 1981, Mrs. Knowles was admitted to Tampa General Hospital (TGH) and was examined by Dr. Jeffrey L. Miller, a rheumatologist internist, at the request of her regular physician, Dr. Sugarman. When Dr. Miller first saw her, Mrs. Knowles was overmedicated. She was confused, and her speech was slurred. She indicated to Dr. Miller that she was taking Triavil and other drugs as well, such as Zomax and Placidyl, but refused to tell him all the drugs she was taking. Those she mentioned are addictive, and it appeared that she was addicted because she had been hospitalized for nonaccidental overmedication and because her condition was consistent with addiction. Mrs. Knowles denied having a drug problem. In Dr. Miller's opinion, however, Mrs. Knowles was not receiving the proper therapy. Her diabetes did not require the drugs she was getting. Her other symptoms, in his opinion, did not justify the apparent liberal prescriptions she was getting and should have been treated with psychotherapy rather than drugs. In his opinion, therapy should be tailored for an individual like Mrs. Knowles so that the medication is limited and regulated to prevent addiction and the buildup of tolerance to a drug, which results in larger and larger doses. The evidence also shows, however, that Mrs. Knowles was a difficult patient. Dr. Sugarman was having difficulty with her and requested the consult by Miller. What must also be considered is that Mrs. Knowles' leg, about which she constantly complained of the pain, was subsequently surgically removed in 1982 as a result of her diabetes. The pain associated with this condition leading up to the amputation was real and required relief to some degree. In any case, Dr. Miller did not ever discuss Mrs. Knowles with Respondent or advise him of her addiction. Mrs. Knowles still receives painkillers and "nerve medicine" from her current physician, Dr. Sugarman, whom she sees every two weeks. She stopped seeing Dr. Warhola when she started seeing Dr. Sugarman, who, she felt, was more current in some of her problem areas than Respondent. She did not leave Respondent because she was dissatisfied with him. In fact, he was the only one who helped her blood clots. According to Respondent, he gave Mrs. Knowles the Placidyl for sleep because she had a lot of pain as a result of her diabetes and needed it to help her sleep. At this same time, Mrs. Knowles' husband was a severe alcoholic and, since she was under a lot of strain because of that, he gave her the drug to help her sleep. The call he got from Dr. Stern on October 26, 1981, when she was in BCH, indicating she was mixing drugs, was the first indication he had that she was abusing drugs. He told Stern she was not to get any more, and he, Respondent, has not prescribed any for her or seen her since. In fact, he was not informed of her hospitalizations in June or August, 1979, or in September, 1981. It is, even by the testimony of Petitioner's expert, Dr. Gladding, not uncommon in Florida for M.D.s to admit a D.O.'s patient to a hospital and not ever notify the D.O. of that fact. Mrs. Clifton M. Wood of Winter Haven, Florida, was first taken to see Respondent for a diet regimen in 1980. On the first visit on February 7, 1980, he gave her a physical examination which included a complete laboratory workup, cardiogram, and weight and pressure check. He gave her some pills which had instructions for use on the bottle, but did not tell her what they were. Each time she came to his office for a visit thereafter, on a monthly basis, either Respondent or his nurse would weigh her and take her blood pressure and adjust her medication as required. During the course of treating Mrs. Wood, Respondent gave her phedymetrazine, an appetite suppressant, methahydrine for high blood pressure, Donnatal, and vitamins and minerals. He gave Mrs. Wood only the drugs he felt she needed in the amount she needed. Mrs. Wood was admitted to Winter Haven Hospital on October 26, 1980, because a neighbor who was concerned about her brought her in. At the time, Mrs. Wood had trouble with dizziness, her balance, and falling. Before this incident, however, Respondent on one or more of his visits, had given her pills for her blood pressure and potassium pills for her to take in water. According to Dr. Gordon Rafool, who had also treated Mrs. Wood since 1979 and who admitted her to the hospital in October, 1989, at the time of admission, she was, among other things, dehydrated and had an electrolyte imbalance (lack of body salt, specifically potassium), the latter possibly being caused by the intemperate use of a diuretic. A diuretic is often used in cases of heart failure, high blood pressure, and, though not recommended, weight reduction, to get rid of body water. Since it was important to know what medicines Mrs. Wood was taking to help determine the reason for her condition, Dr. Rafool and other hospital personnel tried to get an identification of the drugs in Mrs. Wood's possession when she was brought in. The hospital pharmacy could not identify them, and no drug screen was done, but Dr. Rafool obtained a written authorization of Respondent to permit Respondent to release any information regarding drugs dispensed or prescribed to the patient by him. This authorization was forwarded to Respondent's office with a request for Mrs. Wood's medical records, but they were never released. Dr. Warhola's office manager, Mrs. Zacchini, states the request and authorization on Mrs. Wood were received, but were apparently inadvertently filed in the office record without the requested records being sent out. Though Dr. Rafool says that numerous follow-up calls were made to Respondent's office, Mrs. Zacchini denies any were received from either the hospital or Dr. Rafool. In any case, there is no evidence to indicate any calls were made to or received by Respondent directly, and he denies every having received any. Mrs. Wood still considers Respondent to be a good doctor, but she has not gone back to see him since her release from the hospital because Dr. Rafool told her to stay away from him. She has been seeing Dr. Rafool, who has been treating her with pills for her arthritis and high blood pressure. Petitioner presented the deposition of Dr. Lloyd D. Gladding, D.O., over the partial objection of Respondent, whose objection was not to the use of the deposition, but to specific parts thereof based on particular grounds. For example, Respondent objected to Dr. Gladding's testifying as an expert because, he contended, there had been no showing by Petitioner that the witness's experience compares to that of Dr. Warhola. He contends the witness does not practice in the same geographical area nor is there a showing he is a similar health care provider with a similar specialty or a similar type practice. However, Dr. Gladding's curriculum vitae, admitted without objection, shows he is currently co-chairman of a family practice seminar in his area and a clinical preceptor (teacher) at an osteopathic medical school and has been engaged in a family practice in the Fort Myers area since 1978. This area is geographically not far removed from the Tampa Bay area (the distance is not significant) and there is no showing that the patient conditions involved in the two cases at issue would or could be affected significantly by the geographical location of the patient or that treatment of these conditions varies greatly from location to location. In fact, according to this witness, he finds patients from widely differing areas (Pennsylvania, where he was trained, as opposed to Florida, where he practices) to be the same. Accepting the witness as an expert, then, with reference to Mrs. Knowles and her condition, he has had patients with a similar series of health problems where the patient was placed on multiple drug regimens. Sometimes, these patients developed drug dependencies for the different medications he prescribed. In the case of Mrs. Knowles, based on the number of Placidyl prescribed by the Respondent over about a year, she received enough to take two per day, which would constitute 1,500 mg. of the drug per day (two tablets of 759 mg. each). The drug company's recommended daily dose is between 590 and 750 mg. given at bedtime, with an additional 109 to 200 mg. later on, if needed. The fact that Mrs. Knowles was also getting other drugs, including a different type of sleeping pill, makes Dr. Gladding feel the prescriptions by Respondent were excessive. He admits, however, he does not know how much pain the patient was in and this makes it difficult to render an opinion. Because of this, he cannot unequivocally say that the dosage prescribed was excessive. Good practice is to prescribe as few Schedule II drugs as is possible. However, without knowing the patient, her attitude, and her actual condition, an opinion as to the appropriateness of the drugs prescribed, unless clearly inappropriate, would be merely guesswork. As to the patient Mrs. Wood, Dr. Gladding could not read Dr. Warhola's notes of what drugs he gave her. Therefore, in analyzing Respondent's prescriptions, he relied on and referred to a federal drug analysis of the unmarked drugs she got from Respondent as including barbiturates or their derivatives. This analysis was not introduced into evidence, and Dr. Gladding's reference to it is hearsay which cannot, by itself and without other independent evidence of the identity of the drugs, support a finding of fact even though it would appear some were drugs that would not be used in weight control. However, there were drugs identified independently, such as the potassium replacement and the weight reduction drug, which were appropriate and, in addition, the tranquilizer could also be appropriate. In any case, Dr. Gladding does not know what Mrs. Wood told Respondent about the problems she was having sleeping. If she did tell him this, even the barbiturates could be appropriate. Dr. Gladding has also been confronted with a situation where a patient of his has been hospitalized and the hospital calls him for information on the patient on an emergency basis. He knows, he says, everyone in the local hospitals and generally provides the requested information on the spot without a formal release. He is more concerned with the patient's welfare than with technicalities. However, in the case of Mrs. Wood, there was not an emergency situation and there was no showing Respondent was ever personally contacted. In addition, there was evidence of only one written release, not three, as reflected by the witness.
Recommendation Based on the foregoing, it is, therefore, RECOMMENDED: That the Administrative Complaint filed herein against Dr. Warhola be dismissed, but that he be officially reminded of the necessity to conservatively prescribe controlled substances in the course of his practice. RECOMMENDED this 6th day of March, 1984, in Tallahassee, Florida. ARNOLD H. POLLOCK Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 6th day of March, 1984. COPIES FURNISHED: James H. Gillis, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32391 Gerald Nelson, Esquire 4950 West Kennedy Boulevard Suite 693 Tampa, Florida 33609 Mr. Fred Roche Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee. Florida 32301 Ms. Dorothy Faircloth Executive Director Board of Osteopathic Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue The issues to be resolved in this proceeding concern whether the Respondent properly maintained and supplied required records to support and document prescription claims, which it billed to Medicaid and for which it received payment from the Medicaid program during the audit period of April 1, 2000 through December 31, 2001. If that is not the case, it must be determined whether the Agency is entitled to recoup from the Respondent the sum it seeks of $108,478.77, as the purported amount overpaid to the Respondent by the Agency. It must also be determined whether the applicable laws and regulations referenced herein were complied with by the Respondent, in terms of its accepting and filling prescriptions, dispensing relevant drugs, and recording and documenting such activities in its pharmacy records. Finally, it must be determined whether the statistical methodologies employed by the Agency, through its audit and investigation of the Respondent, were sufficiently representative and accurate so as to support the calculation of estimated overpayments.
Findings Of Fact The Petitioner is an Agency of the State of Florida charged by the statutes and rules referenced herein with ensuring that proper reimbursement is effected to providers, including pharmacies, by the Medicaid system. Because of its duty to enforce and regulate the Medicaid system, the Petitioner Agency has an audit and oversight function, as well as an enforcement function, to ensure that Medicaid payments and the general operations of the Medicaid system are carried out correctly. It is through this duty imposed by the cited Florida Statutes and rules, as well as the federal regulations it is charged with enforcing, that the Petitioner carried out an audit of the Respondent, Brown Pharmacy, concerning the audit period of April 1, 2000 through December 31, 2001. The Petitioner conducts audits of providers such as Brown in order to ensure compliance with the Medicaid provisions and Medicaid provider agreements. These are called "integrity audits" and are routinely performed by auditors contracted from private firms such as Heritage. Brown Pharmacy (Brown) is licensed in the State of Florida as a pharmacy (license Number PH562). Brown maintained a business location at 312 West 8th Street, Jacksonville, Florida 32206, at times pertinent to this case. During the audit period Brown was an enrolled Medicaid provider authorized to provide Medicaid prescriptions pursuant to a provider agreement with the Agency. The terms of the provider agreement governed the contractual relationship between Brown and the Agency. Pursuant to that provider agreement, Brown was to maintain the Medicaid-related records and documentation for at least five years. Any Medicaid provider, such as Brown, not in compliance with the Medicaid documentation and record retention policies may be subject to the recoupment of Medicaid payments. During the audit period, Brown dispensed prescription drugs to Medicaid recipients. Medicaid claims were filed and paid electronically as "point of sale" transactions during the audit period. Each claim reviewed and at issue in this case was a paid Medicaid claim subject to the provider agreement and pertinent regulations. As a condition of participating in the Medicaid program, a Medicaid provider must comply with all provisions of a provider agreement, which is a voluntarily agreement between the Agency and the provider. Those provisions include the provider's agreement to comply with all relevant local, state and federal laws, rules, regulations, licensure laws, bulletins, manuals, and handbooks, etc. The provider must agree to keep and maintain, in a systematic and orderly manner, all Medicaid- related records as may be required by the Agency and make them available for state and federal agencies and review. It must maintain complete and accurate medical, business, and fiscal records that will justify and disclose the extent of goods and services rendered to customers or patients and rendered as billings to the Medicaid system. Florida Administrative Code Rule 59G-4.250 promulgates, as part of the rule, the above-referenced handbook (handbook) which sets out Medicaid polices and rules. The polices and rules govern the rights and responsibilities of drug providers, such as Brown, including coverage and payment methodologies for services and goods rendered to Medicaid recipients and billed to the Medicaid program. The types of records that must be maintained are as follows: Medicaid claim forms, professional records such as patient treatment plans, prior and post authorization information, prescription records, business records, including accounting ledgers, financial statements, purchase and acquisition records etc., tax records, patient counseling information and provider enrollment documentation. Providers who are not in compliance with the Medicaid documentation and record retention policies described in the handbook are subject to administrative sanctions and/or recoupment of Medicaid payments. Medicaid payments for services that lack required documentation and/or appropriate signatures will be recouped. Chapter five of the handbook, in defining overpayment provides that any amount not authorized to be paid by the Medicaid program, whether paid as a result of inaccurate or improper cost reporting, improper claims, unacceptable practices, fraud, abuse or mistake, constitutes overpayment. Incomplete records are records that lack documentation that all requirements or conditions for the providing of services have been met. Medicaid may recoup payments for services or goods when the provider has incomplete records or cannot locate the records. The Agency contracted with Heritage to conduct an on- site audit at Brown. The audit was conducted March 18th through March 20, 2002. Heritage isolated a sample of 205 prescription claims, known as the "judgmental sample" out of a total universe of paid pharmacy claims from Brown totaling 16,727 for the audit period. Heritage also selected 250 random prescription claims out of the remaining total universe of paid pharmacy claims of 16,522, which remained after the 205 judgmental sample claims had been removed or isolated from the remainder of the total claims. With the acquiescence of the Agency, Heritage chose the 205 claims by weighing it in favor of the "high dollar" or more expensive drug prescriptions. Those prescriptions are primarily for HIV and Aids therapy drugs and psychotherapeutic drugs for various mental conditions, including schizophrenia. Weighing of the judgmental sample strongly in favor of the high dollar prescription claims would seem to render the judgmental sample fundamentally unfair against Brown if the judgmental sample had then been extrapolated to the entire universe of claims ($16,727). This was not done, however. The judgmental sample was audited and compiled by doing an actual count and totaling of claim amounts in dollars represented by all the discrepant prescriptions, including all those the Agency and Heritage maintained resulted in "overpayments" to Brown. Therefore, the judgmental sample is an actual number rather than an extrapolated calculation so that weighing the sample in favor of the high dollar prescriptions does not result in an unfair or biased sample, as to the judgmental sample. Because the judgmental sample was drawn from the total pool of audited claims and removed from that claim pool prior to the identification and drawing of the random sample, the two are mutually exclusive and the amounts calculated do not represent a duplication or overlap. Thus the findings from the judgmental sample and then the random sample may be properly added together. The randomly selected claims (random sample) were taken of the remaining 16,522 claims in the audit claim pool after the judgmental sample of 205 claims had been removed. According to the report rendered by Heritage, the 250 randomly selected claims totaled $10,632.59 in paid Medicaid dollars. The Heritage auditors determined that there were 56 discrepant claims out of these which totaled, according to their calculation, $2,450.13 in apparent overpayments. This resulted in an average overcharge per claim of $9.80 (determined by dividing the documented "sanction amount" by the total number of claims in the random sample (250), multiplied by the universe of claims from which the random sample was taken (16,522) which yielded an extrapolated overcharge of $161,924.19. Applying the statistically appropriate 95 percent "one-sided" lower confidence limit of this extrapolation resulted in a purported overpayment extrapolated from the randomly selected claims of $102,700.85. This means that the overpayment amount calculated by Heritage represents an amount statistically 95 percent certain to be the lowest amount overpayment based on the extrapolation of the overpayment represented in the 250 randomly selected claims. The non-extrapolated judgmental findings showed, according to Heritage, that there were 72 discrepant claims. Heritage then determined that, of these, there were $29,381.09 in apparent actual overcharges. The discrepancies determined by Heritage involved the failure to produce documentation of refill authorizations for 80 prescription claims; 31 prescription claims containing an incorrect Medicaid provider number; the failure to produce 12 "hard copy" prescriptions representing 25 claims; four claims that did not have the prescriber's DEA number on the prescription for controlled substances; three claims for prescriptions that did not contain the original date of service; two claims that were billed for quantities greater than that authorized by the physician; one claim that was billed for an incorrect day's supply; one claim that was billed in excess of the maximum allowable quantity of prescription of the drug, set by Medicaid policy; and one prescription claim that was billed for an incorrect prescriber's Medicaid provider number (although this should not be a discrepancy because the correct prescriber was documented in the pharmacy's computer, which the regulations allowed). Additionally, there was one claim billed for a drug different than that prescribed by the physician, according to Heritage in its report. Heritage also conducted an invoice review using utilization reports provided by the Respondent. This was apparently a review of 25 different drugs that purportedly showed that the prorated purchases of those drugs were insufficient to cover the number of units billed to Medicaid for all 25 drugs reviewed, and thus yielded a purported shortage of $87,942.13, representing the amount billed to Medicaid above the amount the records of purchases from suppliers proved that Brown had purchased of those drugs. Based upon the Heritage audit as well as documentation findings and overpayments calculations (see Exhibit 8), the Agency issued a PAAR dated September 27, 2002, determining that Brown had been overpaid $150,036.71 for Medicaid claims during the audit period. That report advised Brown that it was a provisional report only and encouraged Brown to submit any additional information or documentation which might serve to change the overpayment. The report listed examples of documentation that the Agency would consider for a possible reduction in the overpayment amount initially claimed. Thereafter, the Agency agreed to an extension of time for Brown to submit additional documentation and sent a letter to Brown dated October 31, 2003, advising that the audit had been placed in abeyance pending the outcome in a related case, but that the Agency expected to resume the audit and that therefore all Medicaid-related records and documentation regarding paid claims should be maintained and preserved until the audit was finalized. The FAAR was addressed in the testimony of Ms. Stewart for the Agency. Through her testimony it was revealed that certain corrections should be made to the FAAR updating it from the findings in the Heritage initial audit report. The Agency corrected the information in the FAAR for this reason and for the reason that it secured some additional information from the Respondent. Thus, for the audit period it was established that there were 16,727 total claims for prescriptions dispensed by Brown, for which it was paid $795,564.59 during the 21-month audit period, of those claims, 205 were pulled out from the total universe of claims as the judgmental sample. There were some 72 allegedly "discrepant claims" totaling $36,393.51 in dollars paid to Brown. The Agency's position is that $29,381.09 of those are so called "documented overcharges." The random sample of 250 claims was extrapolated to the remaining universe of 16,522 prescription claims. The Agency now takes the position that it found 49 "discrepant claims" in the random sample which totaled $2,154.40 in dollars paid to Brown's pharmacy and of that it maintains that $1,927.55 are "documented overcharges" for the 250 randomly selected claims (for which Brown had been paid $10,632.59). Thus the Agency found an average overcharge for the 250 randomly sampled claims of $7.71 per claim. The $7.71 average per claim overcharge was then multiplied by the remaining universe of 16,522 claims, yielding an extrapolated purported overcharge of $127,387.92. The Agency then applied the 95 percent "one-sided lower confidence limit" to this extrapolation, that is, that it or its statistician, Dr. Johnson, felt that there was a 95 percent chance that the lower confidence limit number it calculated was accurate. That number is $79,097.68. When that number is combined with the Agency's position as to overcharges from the judgmental sample results in a total postulated overcharge of $108,478.77. This is the final amount the Agency claims as an overpayment that must be recouped for Medicaid. The FAAR summarized the discrepant claims for the judgmental sample as follows: 61 claims involve refills which exceeded the authorized number of refills without documentation of reauthorization; 10 claims showed an incorrect prescriber license number but the correct prescriber license number was documented in the pharmacy's computer; and For two claims the hard copy description did not have an original date of service depicted on it and did not reference a DEA number. The discrepant claims shown in the FAAR as to the random sample were as follows: There were 19 claims for refills without documentation of refill authorization (refills had been previously authorized, but for the 19 claims at least one refill had been issued beyond the authorization limit); Fifteen claims showed an incorrect prescriber license number on the claim and the license number was not documented in the Respondent's computer; Seven claims showed an incorrect prescriber license number, but the correct license number was documented in the pharmacy's computer; There were seven claims for which the original hard copy prescriptions could not be found on file during the audit period; For one claim the hard copy prescription did not have an original date of service or DEA number; For one claim the quantity paid exceeded the quantity authorized by the prescriber or dispensed to the recipient; and For one claim the number of days supply submitted by the pharmacy was not consistent with the quantity and directions of the prescriber and the quantity exceeded the limit set by the plan. The most common discrepancies with regard to the judgmental sample and the random sample occurred when the Respondent billed refills in excess of the number authorized by the prescriber, without any written authorization for such being provided in the audit process or later. Concerning the random sample, the second most common discrepancy occurred when the claim depicted an incorrect precriber number on the claim and the license number of the prescriber was not documented in the computer. In the judgmental sample the second most common discrepancy occurred when the claim showed an incorrect prescriber number, but the correct prescriber number was documented in the pharmacy's computer. The discrepancies in the FAAR with the indication "UR", references "unauthorized refills." The records of the pharmacy showed that Brown issued refills of prescriptions to Medicaid recipients in excess of the presriber's limit depicted on the prescriptions but showed no written record of a telephonic or written authorization by the prescriber allowing the additional refill or refills. It is also true that as to some or even many of these the Respondent may have obtained verbal authorization, but failed to document that re- authorization. Medicaid policy, the statutory authority cited herein, and the PDSCLR Handbook provide that all verbal orders authorized by the prescriber of a prescription must be recorded either as a "hard copy" or noted in the pharmacy's computer in order to comply with the relevant law cited herein, for record- keeping and auditing purposes under Medicaid policy. The Agency's Statistical Methodology Mark E. Johnson, Ph.D., testified on behalf of the Petitioner. He was qualified as an expert witness in the area of statistical formulas, statistical methodology, and random sampling, including the random sample statistical methodology employed by the Agency in determining the overpayment amount. He is a professor of statistics at the University of Central Florida. Dr. Johnson reviewed the statistical methodology, numbers and calculations arrived at by the Agency and its extrapolation method of arriving at the overpayment amount. He also used his own independent analysis based upon a software package he commonly uses in the practice of his discipline in testing the methodology employed by the Agency and the random sample employed by the Agency and Heritage. The statistical formula employed by Dr. Johnson and the Agency is a standard one routinely used in Dr. Johnson's profession and statistical sampling. He established through his own testing of the methodology that the random sample was appropriate for Medicaid program integrity audits and determinations as employed in this case. The random sampling, according to Dr. Johnson, was employed because it would be time and cost prohibitive to examine individually each of 16,522 claims regarding overpayment issues. The random sampling methodology using 250 randomly chosen samples is a time and cost saving device and yet still presents a "plausible estimate" as established by Dr. Johnson. He established that for the universe of 16,522 claims which were subjected to the random sample and extrapolation statistical analysis and calculation, that such is a reasonable sample for purposes of this audit and that the 250 random samples employed by the Agency are indeed statistically appropriate random samples. His calculation of overpayment was at variance with the Agency's by 55 cents. He established that is not a significant difference since the 95 percent certainty limit of $79,097.68 for the random sample extrapolation analysis is so much lower than the estimate established at $108,478.22. Dr. Johnson established that the Agency had employed appropriate and valid statistical methods in its determination of the above-referenced overpayment amount based upon the random sample of paid claims. The expert testimony of Dr. Johnson, together with his written report in evidence, is credible and persuasive as to the validity of the random sampling of the claims during the audit period and as to the random sample portion of the analysis employed in arriving at the final overpayment calculation and numbers depicted in the FAAR. Dr. Johnson established the appropriateness of the statistical formula, including extrapolation, used to calculate the overpayment amount, the appropriateness of the sample size relative to the universe of claims, and the improbability that the overpayment amount is attributable to chance causes alone. Thus Dr. Johnson's testimony is accepted as credible and persuasive in establishing the validity of the Agency's method of overpayment calculation, and the overpayment calculation in conjunction with the statistical evidence in this record, except as modified by the findings below.1/ The Respondent's Position Gary Steinberg testified on behalf of the Respondent, Brown Pharmacy. He was accepted as an expert witness in the areas of Medicaid policy, audits and pharmacy practice, including Florida pharmacy practice. Mr. Steinberg acknowledged that Brown had not properly documented all claims that had been paid by the Medicaid program nor maintained all required records. He emphasized in his testimony, however, that Brown had not fraudulently billed the Medicaid program with claims for prescription medications that it had not actually dispensed to the patients or recipients. Rather, all medications involved in the subject prescription claims had actually been dispensed. There is no evidence or claim on the part of the Agency that Brown charged and collected more than the appropriate approved price for the prescriptions at issue. Through the explanation given in his testimony, Mr. Steinberg opined that although Brown was guilty of technical errors in record keeping and documentation as to the prescriptions involved in the subject claims, Brown had made substantial compliance with the Medicaid program requirements of the Medicaid provider agreement and the statutes and rules at issue and policies embodied in the subject handbook. He explained in his testimony that in the pharmacy practice setting in which Brown has operated, whereby it serves a large indigent population in an inner city environment, it is difficult to contact a prescriber at the time when a patient needs a critical prescription refilled in order to get a refill authorization. The prescriptions at issue mostly involve critical medications for HIV/Aids and psychotropic medications for severe mental conditions such as schizophrenia. The patients who need these critical medications (and there are very few patients, since most of the procedures involve filling and refilling for a small number of such recipients) are patients of clinics operated at the nearby university hospital (Shands). In these circumstances, where the patient literally needs the HIV/Aids medication refilled on an immediate basis, possibly even to prevent death, and the mental health patient critically needs a refill in order to prevent harm to the patient or harm to the members of the public if the patient goes without medication and "decompensates," the ethical thing for a pharmacist to do is to refill the prescription and seek authorization later. Mr. Steinberg established that it is often difficult to obtain authorization from the original prescriber since the medication were prescribed by residents practicing in the various clinics at the Shands Hospital and that the residents can not always be identified or contacted easily since they do not maintain a fixed medical practice in the area. Consequently, some of the prescriptions were not documented as to authorization, although in some cases the pharmacy actually obtained authorization and entered it in its computer. In some cases, being unable to obtain re-authorization from the resident who originally prescribed the medication the pharmacy used the DEA license or prescribing number of the hospital itself. He explained that although under the law a pharmacy can refill a prescription on an emergency basis for up to a 72-hour supply, that this is generally impracticable and unsafe for patients in this plight because such indigent, mental health and HIV/Aids patients tend to be non-compliant with their medication regimes quite often anyway, and it is often unreasonable to expect them to return to the pharmacy for another refill within two or three days. He thus opined that the ethical and safe thing for the pharmacist to do was to refill and re-dispense the medical approved medication for up to a 30 or 34-day supply (the normal refill supply duration). He further explained that the Shands Hospital license number was used in some of these circumstances because the resident doctor who originally issued the prescription could not be identified on the Shands Hospital prescription forms and because the resident doctors at the Shands clinics only have and can use Shands Hospital prescription forms in any event. Mr. Steinberg thus established that 35 percent of those prescription claims classified as "WMP," that is the prescription claims contained an incorrect prscriber license number were for these reasons and the pharmacist could only use the Shands Hospital license number because the resident could not be identified from the Shands Hospital prescription forms. He thus opined that 35 percent of the random sample extrapolation amount, the 95 percent statistical confidence limit amount of $79,097.00, should be deleted from that amount in determining the correct amount of overpayment predicated on the random sample. Likewise, with regard to the judgmental sample concerning the HIV/Aids and mental health patient prescriptions and related claims, he opined that, in effect, $19,500.00 of the total $29,381.09 overpayment amount claimed by the Agency pursuant to the judgmental sample portion of the claims, should be deleted from that portion of the overpayment claim by the Agency; this is a result of his explanation regarding "substantial compliance" in the critical refill situation he described concerning the HIV/Aids and mental health patients and their prescription drugs. The preponderant, persuasive evidence does establish (and indeed the Agency acknowledged in its Proposed Recommended Order) with regard to the judgmental sample, that 10 of the claims at issue listed an incorrect prescriber license number, but that the correct prescriber license number was actually documented in the pharmacy's computer record with the name of the prescriber. This circumstances comports with the law referenced below and in the Petitioner's Proposed Recommended Order. This results in a reduction in the overpayment claim with regard to the judgmental sample of 13.88 percent of the judgmental sample claims or a reduction of $4,078.09. Likewise, with regard to the random sample extrapolation calculation of overpaid claims, the preponderant, persuasive evidence, also as acknowledged by the Agency in its Proposed Recommended Order, disclosed that seven claims listed an incorrect prescriber license number on the claims, but had been correctly documented in the pharmacy's computer system and therefore were in compliance with the relevant statutes, rules, and the subject handbook. Thus the discrepant claims and the overpayment amount related to the random sample portion of the audit claims should be reduced by 14.28 percent of the total amount of $79,097.00 for a $11,295.05 reduction of that $79,097.00 random sample overpayment amount. Mr. Steinberg demonstrated that Brown was not overcharging on the drugs prescribed and dispensed and was charging the Medicaid-authorized amount for the drugs involved in the prescription claims at issue. The Agency is not claiming that there was any fraudulent practice or illegal overcharging for the prescriptions involved. In fact, Brown was earning only a very small profit on the drugs dispensed that are the subject of the prescription claims at issue. Mr. Steinberg thus opined that since Brown did indeed dispense all the drugs at issue and was only paid the legal authorized amounts for the drugs and prescriptions at issue that recoupment of the amounts sought by the Agency or, in effect, established in these findings of fact, would be fundamentally unfair. He and the Respondent contend, rather, that since Brown performed substantial compliance, but was guilty of technical non-compliance with the relevant rules, agreement, and Medicaid policy, that the Agency should impose a lesser fine instead of seeking recoupment. In summary, in view of the preponderant persuasive evidence establishing the above facts, it has been shown that the documentation and record-keeping, dispensing errors, and omissions in the manner found above, with regard to the prescription claims and types of claims addressed in the above findings of fact, occurred. If those deficiencies amount to violations of the authority cited and discussed below which justify recoupment, then the amount of overpayment established by the above findings of fact is $93,104.95.
Recommendation Having considered the foregoing findings of fact, conclusions of law, the evidence of record, the candor and demeanor of the witnesses, and the pleadings and arguments of the parties, it is, therefore, RECOMMENDED that a final order be entered by the Agency for Health Care Administration providing for recoupment of $93,104.95, and that the Respondent, Brown Pharmacy, must re-pay that amount to the Petitioner Agency, through a reasonable re- payment plan established between the parties. DONE AND ENTERED this 3rd day of November, 2006, in Tallahassee, Leon County, Florida. S P. MICHAEL RUFF 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 Clerk of the Division of Administrative Hearings this 3rd day of November, 2006.
Conclusions This cause came before the Agency for Health Care Administration for issuance of a Final Order. 1. On May 23, 2013, the Agency sent a letter to the Petitioner notifying the Petitioner that it owed an overpayment in the amount of $50,992.15 to the Agency based upon an adjustment in the Petitioner's overpayment rates (Exhibit A). On June 17, 2013, the Petitioner filed a Petition for Formal Hearing and the Agency Clerk referred the Petition for Formal Hearing to the Division of Administrative Hearings for further proceedings. On July 1, 2013, the Administrative Law Judge assigned to the case entered an Order Closing File and Relinquishing Jurisdiction based upon a Joint Motion to Relinquish Jurisdiction filed by the parties. On May 23, 2014, the Agency rescinded the overpayment letter (Exhibit B). The Agency’s rescission of the overpayment letter has rendered this matter moot. Filed August 14, 2014 9:30 AM Division of Administrative Hearings a tenE’ AGENCY CLERK P 3 3u Based on the foregoing, IT IS THEREFORE ORDERED AND ADJUDGED THAT: Respondent’s right to a hearing in this matter has been rendered moot and the Agency’s May 11, 2013 overpayment letter is rescinded. The parties shall govern themselves accordingly. DONE AND ORDERED this g day of Avnus® ; 2014 in Tallahassee, Leon County, Florida. AGENCY FOR HEALTH CARE ADMINISTRATION
Findings Of Fact Petitioner is a pharmacist doing business as Dyal's Pharmacy in Daytona Beach, Florida. Petitioner is a Medicaid provider under the rules of the Respondent, operating under Provider No. 1018147. Respondent is a department of the State of Florida, with its principal office in Tallahassee, Leon County, Florida. Respondent is designated as the state agency responsible for the administration of Medicaid funds, and is authorized to provide payments for medical services, pursuant to Section 409.266, Florida Statutes. Pursuant to his responsibilities as a Medicaid provider and a pharmacist, Petitioner has, during the period of March, 1982, through August, 1983, filled 43 prescriptions for nonsteroidal anti-arthritic drugs other than buffered aspirin, which did not have the words "medically necessary" written on the prescription form by the prescribing physician in his own handwriting. Petitioner filed claims with Respondent with regard to the aforementioned prescriptions, and Respondent paid $854.44 to Petitioner as reimbursement. By letter received by Petitioner on December 27, 1983, Respondent has notified Petitioner of its intention to seek repayment of that amount pursuant to Rule 10C- 7.42(4)(b), Florida Administrative Cede. Rule 10C-7.42, Florida Administrative Code, provides, in pertinent part, as follows: (4) Covered Benefits * * * (b) All prescriptions for buffered or enteric coated aspirin must indicate that an arthritic condition is being treated and dispensed in quantities no less than 200. Any nonsteroidal anti-arthritic drug, other than buffered aspirin, must have `medically necessary' written on the prescription by the practioner in his own handwriting. Noncompliance will warrant recoupment. Petitioner has sought an informal hearing regarding Respondent's attempt to recoup amounts previously paid to Petitioner, but in light of the provisions of the challenged rule it is unlikely that he can prevail. The existence of Rule 10C- 7.42(4)(b) is the only basis upon which repayment could be demanded by Respondent from Petitioner. The Florida Medicaid Program is administered through Respondent. In order to receive federal matching funds, Respondent must implement certain mandatory services for indigent. Other services which may qualify for federal funds are optional, and the state may cheese not to implement those programs. The pharmacy program, which this rule purports to regulate, is one such optional service which the State of Florida has chosen to implement. Funds utilized in the Medicaid Program are controlled by the legislature through funding of Respondent's budget. To regulate its budget, Respondent regularly reviews utilization and implements cost containment in various program. In 1981, Respondent was required to reduce its budget, and approximately $2 million of that reduction was required to be made in the Medicaid Program. In considering various options to reduce the Medicaid budget by this amount, the Department reviewed the pharmacy program budget which is the third largest in the Medicaid Program. Options such as limiting the number of prescriptions and requiring full payment were considered since these options had been implemented in other states. Such restrictions were not initiated, however, because Respondent felt that the large elderly population in Florida would forego taking necessary medication and endanger their health. Specific medications which were being paid for through the prescribed drug program were reviewed and certain drugs were eliminated from reimbursement under the program when prescribed for specified reasons, and other drugs were eliminated completely. These categories eliminated were chosen which would have the least detrimental effect on recipients. Additionally, Respondent, in consultation with physicians and pharmacists, considered the use of nonsteroidal anti-inflammatory drugs for the treatment of arthritis. While the drug of choice for treatment of arthritis is aspirin, because it is more effective than most nonsteroidal anti-arthritics, these nonsteroidal anti-arthritic drugs may be necessary for some patients who can't take aspirin. The number of persons who require such drugs instead of aspirin is small, however, and would not justify the large percentage of prescriptions for the nonsteroidal anti-arthritics which Respondent had observed through administering the pharmacy program. Because of their relatively high cost, nonsteroidal anti-arthritic drugs were accounting for 9.6 percent of the pharmacy program budget. Instead of eliminating the entire category of nonsteroidal anti- arthritic drugs from reimbursement under the program, which some states have implemented, Respondent opted to add aspirin to the list of covered benefits when prescribed for arthritis, and to require that the term "medically necessary" be written by the physician on the prescription form for nonsteroidal anti- arthritic drugs in order to be eligible for Medicaid reimbursement. This procedure was initiated in an effort to direct physicians' attention to the cost differential between the two types of drugs to ensure that a physician was making a conscious decision when prescribing the more expensive nonsteroidal anti-arthritic medication. The term "medically necessary" was chosen because physicians were familiar with that phrase through its use under the Florida Generic Drug statute. In response to an inquiry from the Florida Medical Association concerning the use of the term "medically necessary, Respondent indicated to that group that the term "drug of choice" would be an acceptable alternative. The challenged rule had not been amended at the time of final hearing in this cause to reflect this alternative term, nor was there any indication of record that any group other than the Florida Medical Association had been notified of Respondent's policy choice in this regard.
