Final Order No. DOH-08-1781- S - FILED DATE - artment of Health STATE OF FLORIDA By: {hh DEPARTMENT OF HEALTH Deputy Agency Clerk Florida Home Health Equipment & Supplies, Inc. ; Petitioner, VS. Department of Health; Drugs, Devices, & Cosmetics Program; Respondent. FINAL ORDER This proceeding was initiated by a petition requesting an administrative hearing to challenge the Department of Health’s intent to deny the Petitioner’s application for permits to operate a medical oxygen retail establishment and a compressed medical gas wholesaler establishment pursuant to the Florida Drug and Cosmetic Act, Chapter 499, Florida Statutes. The Petitioner was notified of the Department’s intent by a letter dated June 12, 2008; which is identified as Exhibit A and incorporated by reference. Subsequently, the parties resolved this matter in a “Settlement Agreement” executed July 17, 2008; which is identified as Exhibit B and incorporated by reference. Counsel for both parties request that this case be closed based on the “Settlement Agreement”. Based on the foregoing, the “Settlement Agreement” is approved, and the parties are directed to comply with it. DONE and ORDERED this re iis day of August 2008 in Tallahassee, Florida. Ana M. Viamonte Ros, M.D., M.P.H. State Surgeon General By: E. Metts, C.P.A., M. ty Secretary A Florida Home Health Equipment & Supplies, Inc. p.2 of 2, Final Order, DOAH no.: 08-3325 Copy furnished to each of the following: Michael P. Gennett, Esq. Jennifer L. Condon, Esquire Shutts & Bowen, LLP Department of Health 201 S. Biscayne Blvd., 4052 Bald Cypress Way, bin A-02 Suite 1500 Tallahassee, Florida 32399-1703 Miami, Florida 33131 Rebecca R. Poston S.M. Lerner, ALJ Department of Health Division of Administrative Hearings Drugs Devices & Cosmetics Program 1230 Apalachee Parkway 4052 Bald Cypress Way, bin C-19 Tallahassee, Florida 32301-3060 Tallahassee, Florida 32399-1739 CERTIFICATE OF SERVICE I CERTIFY that a copy of the foregoing Final Order has been served by ordinary mail via the United States Postal Service, hand delivery, or by inter-office mail to each of the above named persons this { day of August 2008. Department of Health 4052 Bald Cypress Way, bin C-01 Tallahassee, Florida 32399-3251 phone: (850) 245-4121 0€-20:(66-WW)) NOLLYUNG « SPSSErEZOW-CISD » 998/:SING » GRIEAUASXVATUAS f Toul} ; nn Md LY OADU + $2 BOWE ang WL 2 PA (2: 09 [ ofFice OF THE CLERK STATE OF FLORIDA | DEPARTMENT OF HEALTH FLORIDA HOME HEALTH | EQUIPMENT & SUPPLIES, Petitioner, ; vs. PERMIT NO(S).:32:800 | 31:870 DEPARTMENT OF HEALTH, a ' SETTLEMENT AGREEMENT FOR FINAL ORDER IT IS AGREED AND STIPULATED by and between Florida Home Health Equipment & Supplies (referred to as “Petitioner” or “Applicant”) and the State of Florida Department of Health, through its Drugs, Devices and Cosmeti¢s Program (referred to as “Respondent” or “Department”), collectively referred to bs the Parties that: 1. The Department of Health, through its Division. of Medical Quality Assurance, Board of Pharmacy/Drugs, Devices and Cosmetics Prograin (“DDC”), 4052 Bald Cypress Way, Bin C-04, Tallahassee, Florida 32399 is responsible for, among other duties under the Florida Drug and Cosmetic Act, Chapter 499, Florida Statutes (the “Aet”) and the rules adopted thereunder, Fla. Admin. Code Rule 64212, the regulation and permitting of prescription drug wholesaling and distributing in and into Florida. 2. On or about March 27, 2008, Applicant submitted a change of address application to Respondent for its medical oxygen retail and compresspd medical gasses wholesaler establishments located at 4378 L.B. McLeod Road, Orlando, Florida 32811 MIADOCS 2903634 1 ard SPSSEFBLOFr , HLWW3SH AWOH 14 SO?tTT 22 4eW Lo02 G€-ZO:(SS-WH!) NOLLYYNG « SPSSEPEZOP:CISO » OS8ZISING « SMAAUTSXVAUAS » [oul UByAEC wera WY SS:ZLiLb 800ZIZLIZ LY GAON . SE OW (hereinafter “Change of Address Application”) to operate at 4700 LB. McLeod Road, Suite 5, Orlando, Florida 32811 (hereinafter referred to as the “Establishment”, 3. On or about June 12, 2008, Respondent notified Applicint that it intended to deny Applicant’s Change of Address Application (hereinafter referred to as “Notice of Intent”). Petitioner disputed one or more of the Respondent’s allegations contained in the Notice and requested an administrative hearing pursuant to Section 120.571), Florida Statutes, by timely filing a Petition for Formal Administrative Hearing. 4, This matter is pending at the Division of Administrative Hearings, issued case number 08-3325. : 5. By execution of the Settlement Agreement for Final ‘Order and by the filing of the subsequent Final Order in this cause, the Parties intend to:and do resolve all issues pertaining to the pending administrative proceeding. 6. Applicant does not admit the allegations contained ini the Respondent’s Notice of Intent. 7. Respondent agrees to issue a medical oxygen retailer establishment and compressed medical gasses wholesaler establishment permit to Petitioner at 4700 L.B. McLeod Road, Suite 5, Orlando, Florida 32811, 8. Petitioner agrees to withdraw its petition for hearing involving disputed material facts with the Division of Administrative Hearing. . 9. Petitioner voluntarily enters into this Settlement Agreement for Final Order. Petitioner waives the right to a hearing in this matter and all, further and other proceedings to which it may be entitled by law or administrative rules with respect to the notice of intent. Petitioner hereby knowingly and voluntarily waives all rights to MIADOCS 2903634 1 SPSSE+BLOF H11B3H SWOH Td SO'TT 22 4e8W L002 0£-0+(S5-Uu) NOILVUNG » SPSSEPBLOP:CISO » 9GBZISING x GRUIBAUSSXVAUAS « foun u6nked wera WY SE:ZLiLb 800Z/ZLI2 LV GADU » Sit 30Vd challenge or to contest this Settlement Agreement or the Final: Order issued by Respondent in any forum now or in the future available to it, including the right to any administrative proceeding, circuit or federal court action, or any appéal, with respect to the Notice of Intent. Petitioner reserves the right to challenge any further actions of any state agency which relate to the allegations set forth in the Notice of Intent. 10. Each party to this proceeding shall bear its own costs anil attorney fees, 1 This Settlement Agreement is a legal and binding dochiment and is fully enforceable in any court of competent jurisdiction. The signatories hereto represent that they have read this Settlement Agreement and are authorized to execte it on behalf of their respective principals and, as duly designated representatives, fo fully bind such principals, as well as the Parties’ successors and assigns. : WHEREFORE the Parties request a final order adopting this Settlement Agreement as final agency action. . F ‘OR FLORIDA HOME HEALTH EQUIPMENT & SUPPLIES, Signature Donna Raadla zp _\). p Printed Name and Title Dated: TH71O% MIADOCS 2903634 1 SPSSErsL.or H17B3H SWOH 74 SO?TTt @¢ 4eW 4002 0€-207(S5-UHL) NOILYUNG « SPSSEPBZOP:CISO » OSBZ*SINC » GUBAUASXWAUAS « [oul] BAER worse WY 8S:Zb:b} B00Z/2HZ LV CAD «S/S BOWE MIADOCS 2903634 1 SbSSErBL.or RNEYS FOR FLORIDA HOME ‘TH EQUIPMENT AND SUPPLIES, Michael P. Gennett, Esquite Florida Bar No. 097871 | 01/South Biscayne Blvd. ; te 1500 : Miami, FL 33131 i Telephone: 305-358-6300 | Facsimile: 305-347-7856 |: Dated: “1 al O FOR THE DEPARTMENT OF HEALTH Drugs, Devices and Cosmetics Program 4052 Bald Cypress Way, Bin C04 : Tallahassee, Florida 32399 Rebecca Poston, R. Ph. Director Dated: 7 (7[ 0$ ATTORNEY FOR THE DEPARTMENT Jenni , Condon, Esquite Assistant General Counseli Florida Bar No. 0011116 ; Department of Health 4052 Bald Cypress Way, BIN #402 Tallahassee, Florida 32399-1703 Telephone: 850-245-4025 : Facsimile: 850-413-8743 . Dated: (2) HiTW3H AWOH 14 SO?TT 22 4eW 24002 Charlie Crist Ana M. Lemonte Ros, M.D., MPH Governor State Surgeon General CERTIFIED MAIL/RETURN RECEIPT REQUESTED June 12, 2008 ' Donna Randazzo Florida Home Health Equipment & Supplies 4700 L.B. NeLeod Road Suite 5 Ortando,. FL 32811 RE: Change of Address Applleation . Dear Ms. Randazzo: cy On orabouit March 27, 2008, the department received a request for a charjge of address for Florida Home Health Equipment & Supplies, to operate a Medical Oxygen Ratall Establiehment and a Compressed Medical Gas Wholesaler Establishment at 4700 L.B. Melaod Road, Suite 5, Orlando, Florida, Upon careful review, the department intends to deny the application based upon the following facts, graunde and considerations: Section 499.067(1)(a), F.S., authorizes the department to dany an appli ion for permit if there has been a substantial fallure to comply with Sections 499-001 ~ 499.081, IF.S., ar the rules adopted thereunder. The failure to meet the criteria for obtaining a permitlis a substantial failure to comply with the provisions of Sections 499,001 ~499.081,F.S. Sectlon 499.067 (1) (b), F.S., further authorizes the department to deny an application for a permit ifthe department finds that It would be a danger or would nat be In the best interest of the public health, safety, and welfare if the applicant were issued a permit or certification; If the app cant has not met the ‘requirements for the permit or certification: or, If the applicant demonstrates any of the conditions enumerated in Section 499.01 or Section 489.012 (5), F.S. The department has adopted through the rulemaking process the application form for obtaining , a medical axygen retail establishment permit and a comprassed medical gas wholesaler establishment permit, and passage of an inspection is required. . Facts upon which denial is based On April 28, 2008, an agent for the department canducted an inspection o the above referenced establishment and upon a review of the application submitted, and recommends dental of licensure based an the following facts that were demonstrated at)the inspection. 1. Araview of firm records revealed the firm was selling medica) axygen ta EMP from March 14, 2007 to April 14, 2008 when EMP did not hold a pepmit with the department to purchase medical oxygen. The records also in icated the Tirm was selling medical oxygen to Gompiete Home Services Managernent Corp. CCHS’) from October 5, 2006 to April 18, 2008 when CHS did nat hold a permit with the department.to purchase medical oxygen. : Digs, Devices, and Cosmetics Program 4052 Bald Cyp ee, FL, 32399 Telephone (8. 413-6982 K SpSSErBdOr MMOH 4 sWel@Secor HLLTHSH SWOH To Hd6Si2 Bode ‘ST one ra JUN-19-2008 THU 03:50 PM @ a FA HO. 2, 07 er. : DO-COHes-UiH) NOILYLNG « GPSECPEZONCISS « DSELISING « }HHBAMSSXY SUAS o fouls juBidng wyajena) wid APOtP BOOZIOFIO LW GADD » Sib HOVE Florida Home Health Equipment & Supplies, June 12, 2008 Page 3 B, Section 499.01 (5)(d)7, F. 8. The Applicant's compliance with permitting requiramants under previously granted parmits by operating without the proper permit and selling prescription medical oxygen to a person not authorized to purchase. 2. Applicant was in violation of Section 499,005(15), F.S. by salling and/or transferring prescription medical oxygen io parsons who did not hold a parmit to purchape or possess medical axygen. J fC 3. Section 499.0122(2)(c}, F.S, mandatae medical oxygen retall establishments comply - with all of the wholesale distribution raquirements of s. 499.0121, —.S. Thelfirm has violated Sectian 499.0121(6)(a)2. 3., FS, and Rule 64F-12,012(2)(8), F/A.C. by falling to list te permit number which authorizes the firm to possess and transfer medical oxygen, ‘ailing to. list the permit number of the recipient authorized to purchase and/or receive medidal oxygen and _falling to list the size of the oxygen tank helng delivered and/or sold. 4, Section 499.0122(1)(a), F.S., mandates that sales of medical oxygen must be based on an order from a practitioner authorized by law to prescribe, Rule 64F-12.0 214}, F.A.C,, states .. that medical oxygen ratailere must maintain a written prescription or other rder of an authorized practitioner evidencing the authority of the recipient te recelve medical oxygan. The firm has violatad Section 499.0122(1)(a), E.S, and Rule 64F-12.01 2(4), F.AC. by failing to maintain a written order far patients to which medical axygan was being de iverad and/or sold. 5. The firm has-violated Section 499.0121(7), F.5., by falling to establish written policies and procadures to be foliowed for. handling recalls, distribution and inventory. 6. Sectian 499.005(22), F.S. prohibits a persan from aperating without a valid permit when ona js required. Sectian 499.012(2)(b), F.8, requires @ persan to hold a rmit to distribute medical oxygen to one other than the consumer or patient. The firm has v ated Section . 494,005(22) and 499.01 2(2)(b), F.S. by selling medical oxygen fo a wholesaler without helding a valid permit. : 7, Passing an on -site inspection conducted hy the department is @ P' obtaining a permit to operate as a medical oxygen Tetail establishment in Florida, saction B4F-12.015(3), F.A.C, The Applicant did not pass the inspection F above. This is a substantial failure to comply with a rule adopted under S 499.081, F.S. Thie is also 4 failure to meet the minimum permit requirements. The permit is - denied pursuant to Section 499.087(1)(b)2, FS. . the department finds that it would be @ danger or not In the best interest offthe public health, 8. Pursuant to Section 499.067(1)(b)1., F.S., based on the findings mpde at the inspection, safety and welfare if the applicant ware issued @ permit to operate as a Aes oxygen retail establishment. Q, The deficiencies and violations described above, or any one of then is a substantial failure te comply with the provisions of Chapter 499 Part | F.8. or rules adgpted thereunder. Therefore, the application is denied pursuant to Section 499,067(1)(a) F.S' ~ es ; pets sDDs a SrSSEvBL04 HATHA SWOH Vat WdeStze enbde gi unc s° JUN-19-2008 THU 03:51 PM @ fms ta. fs { 00-L0:(S6-UIU) NOILWUNG « GPESEPELOP IRD «ORSLISING v LLRIBAUBEX WAHAB y fouij, UGHAEg WaieEg) Wid OY'GOrr SOUTH LV CADE + GIG ADWe Florida Hame Health Equipment & Supplies, dune 12,2008 - Page 4 ‘ Having considered the above factors, the department hereby intends to dany the change of address application of Florida Home Health Equipment & Supplies medical axygen retail establishment and a compressed medical gas wholesaler establishment. NOTICE OF RIGHTS TO HEARING AND APPEAL You have the right to request an administrative hearing pursuant to Sections 420,589, 120.87, F.S., If you wish to challenge the Intended agencyjactian to dany your application for permit, Such proceedings are governed b: Sections 420.569, 120,57, F.S,, and seation 28-106, Fiorida Administrative Gpde (F.A.C.)° _A requast far a hearing involving disputed Issues of material fact must comply ~ with séetfon 28-108.2017 FAG. A requést tor a Tearing fot IAVOMING diéputed. ~~~ © issues of material fact must comply with ection 28-106.301, FAC. representative, at your expanse; to present avidance and argument! to call and : cross-examine witnesses; and to have subpoena and subpoana duces tecum You have the right to be represented by counsel or ather qualified f issued on your behalf if a hearing is requested. the Agency Clerk for the Department, within fventy-one (21) days ftom the Teceipt of this Notice, The address of the Agency Clerk is 4052 Bald Cypress Way, BIN # 402, Tallahassee FL 32399-1703. The Agency Clark's! facatmile number is 850-410-1448, - A petition far administrative hearing must be in writing and must be fen by. Mediation is not available as an alternative remedy. Your failure te submit a patition fer hearing within twenty-one (21) days from receipt of this notice will constitute a waiver af your right to an admipistrative hearing, under section 28-106.111, F.A.C., and this notice shall begome a “final order". : . Should this notice become a final order, a party who is adversely affected by it is entitied to judicial review pursuant to Sactlon 120,68, F.S. Review rocaedings are governed by the Florida Rules of Appellate Procedure. Such proceedings may be commenced by filing one copy of a Notice of Appeal with the Agency Clerk of the Depariment of Health and a secand copy, accampanied by the filing fees required by law, with the Court of Appeal In the appropriate Ficrida Appellate District. The notice must be filed within thirty (30) days of rendition of the final order. : . Rebacca’R, Poston, R.Ph. Executive Director L Drugs, Devices, & Cosmetics Program S+SSEPBLOF HLQWaH AWOH J4 | HesSie Boor st unc = et

Docket for Case No: 08-003325

Issue Date	Proceedings
Aug. 26, 2008	Order Closing File. CASE CLOSED.
Aug. 20, 2008	Final Order filed.
Aug. 15, 2008	Notice of Settlement filed.
Jul. 24, 2008	Amended Notice of Hearing by Video Teleconference (hearing set for September 2, 2008; 9:00 a.m.; Miami and Tallahassee, FL; amended as to Miami Hearing Location ).
Jul. 18, 2008	Order Directing the Filing of Exhibits.
Jul. 18, 2008	Order of Pre-hearing Instructions.
Jul. 18, 2008	Notice of Hearing by Video Teleconference (hearing set for September 2, 2008; 9:00 a.m.; Miami and Tallahassee, FL).
Jul. 16, 2008	Respondent`s Amended Response to Initial Order filed.
Jul. 14, 2008	Respondent`s Response to Initial Order filed.
Jul. 10, 2008	Initial Order.
Jul. 10, 2008	Denial of Application filed.
Jul. 10, 2008	Petition for Formal Administrative Hearing filed.
Jul. 10, 2008	Notice (of Agency referral) filed.