Prime Health Med. Svcs. Co. Laila Gomaa, MD. (PD PMC)

7/28/2019 Prime Health Med. Svcs. Co. Laila Gomaa, MD. (PD PMC)

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OHIO STATE BOARD OF PHARMACY77 South High Street, Room 1702; Columbus, OH 43215-6126

-EqualOpportunityEmployerand Service Provider-TEL: 614/466-4143 E-MAil.: [email protected] FAX: 614/752-48361TYITDD: Use the Ohio Relay Service: 1-800/750-0750 URL: http:// www.pharmacy.ohio .gov

PROPOSAL TO DENY/NOTICE OF OPPORTUNITY FOR HEARING

June 5, 2013

PRIME HEALTH MEDICAL SERVICES, INC.C/O LAlLA GOMAA, M.D.8120 GARNET DRIVEDAYTON, OH 45458

Dear Ms. Gomaa:

Re: Application fo r Registrat ion as aTerminal Distributor of DangerousDrugs with a Pain ManagementClinic Classification

YOU AREHEREBY NOTIFIED, in accordance with the provisions of Section 119.07 of theRevised Code, that your application fo r registration as a Terminal Distributor ofDangerous Drugs with a Pain Management Clinic Classification pursuant to Sections4729.54 and 4729.552 of the Revised Code has been proposed to be denied.The reason fo r this proposal is that the Board has evidence which leads it to believethat you do not qualify fo r registration under Sections 4729.55 or 4729.552 of theRevised Code. Specifically, you have no t furnished satisfactory proof to the Board thatyou meet the quali fi cations enumerated therein and pursuant to rule. The specificevidence in support of this act ion is as follows:(1) Records of the Board of Pharmacy indicate that on or about June 14, 2012, youwere the Responsible Person, fo r PRIME HEALTH MEDICAL SERVICES, INC., 8120GARNET DRIVE, DAYTON, OH 45458, and that on June 14, 2012, PRIMEHEALTH MEDICAL SERVICES, INC. applied fo r registration as a Terminal

Distributor of Dangerous Drugs with a Pain Management Clinic Classification.(2) The Owner and President of Prime Health Med ical Services, Laila I. Gomaa,M.D., has fai led to furnish satisfactory proof to the Board that she shall be in

control of the facility that is owned and operated solely by one or morephysicians authorized under Chapter 4731. of the Revised Code to practicemedicine and surgery or osteopathic med icine and surgery. Specifically,Health Maintenance Partners, Inc. is owned by Laila I. Gomaa, M.D. On June21, 2012 , Ms. Gomaa permanent ly surrendered her cer ti fi cate to practicemedicine and surgery in the State of Ohio. Such is contrary to Sections4729.55 and 4729 .552 of the Ohio Revised Code, and Sections 4731-29-01and 4729 -9-19 of the Ohio Administrative Code .


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PRIME HEALTH MEDICAL SERVICES, INC.c/o LAlLA GOMAA, M.D.Page 2Notice of Opportunity

YOU ARE HEREBY ADVISED that Section 4729.55 of the Ohio Revised Code provides inpertinent part that :No license shall be issued to an appl icant fo r licensure as a terminaldistributor of dangerous drugs unless the applicant has furnishedsatisfactory proof to the board of pharmacy that:

(A) The applicant is equipped as to land, buildings, and equipment toproperly carryon the business of a terminal distributor of dangerous drugswithin the category of l icensure approved by the board.

(B) A pharmacist, licensed health professional author ized to prescribedrugs, animal shelter licensed with the state board of pharmacy undersection 4729 .531 of the Revised Code, or a laboratory as def ined in section3719.01 of the Revised Code wil l maintain supervision and control over thepossession and custody of dangerous drugs that may be acquired by or onbehalf of the applicant.

(C) Adequate safeguards are assured to prevent the sale or otherdistribution of dangerous drugs by any person other than a pharmacist orlicensed health professional authorized to prescribe drugs.

(D) Adequate safeguards are assured that the appl icant wi ll carry on thebusiness of a terminal distributor of dangerous drugs in a manner that allowspharmacists and pharmacy interns employed by the terminal distributor topractice pharmacy in a safe and effective manner.

(E) If the applicant, or any agent or employee of the applicant, has beenfound guilty of violating section 4729.51 of the Revised Code, the "FederalFood, Drug, and Cosmetic Act," 52 Stat. 1040 (1938), 21 U.S.c.A. 301, thefederal drug abuse control laws, Chapter 2925., 3715., 3719., or 4729. ofthe Revised Code, or any rule of the board, adequate safeguards are assuredto prevent the recurrence of the violation.

mIn the case of an applicant wh o is a pain management clinic, theapplicant meets the requirements to receive a license with a painmanagement clinic classification issued under section 4729.552 of theRevised Code.


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YOU ARE FURTHER ADVISED that Section 4729.552 of the Ohio Rev ised Code providesin pert inent part that :(A) To be eligible to receive a license as a category III terminal distributorof dangerous drugs w ith a pain management clinic classification, anapplicant shall submit evidence satisfactory to the board that the appl icant'spain management clinic wil l be operated in accordance with the requirementsspecified in division (B) of this section and that the applicant meets any otherapplicable requirements under this chapter or Chapter 3719. of the RevisedCode.

(B) The holder of a terminal distributor license with a pain managementclinic classification shall do all of the following:

(l) Be in control of a facil ity that is owned and operated solely by one ormore physicians author ized under Chapter 4731. of the Revised Code topractice medicine and surgery or osteopathic medicine and surgery;(2) Ensure that any person employed by the facility complies with therequirements for the operation of a pain management clinic established bythe state medical board in rules adopted under section 4731.054 of theRevised Code;(3) Require any person with ownership of the fac il ity to submit to acriminal records check in accordance with section 4776.02 of the RevisedCode and send the results of the criminal records check directly to the stateboard of pharmacy for review and decision under section 4729.071 of theRevised Code;(4) Require all employees of the facility to submit to a criminal recordscheck in accordance with section 4776.02 of the Revised Code and ensurethat no person is employed who has previously been convicted of, or pleaded

guilty to, either of the following:(a) A theft offense , described in division (K)(3) of section 2913.01 of theRevised Code, that would constitute a felony under the laws of this state, any

other state , or the United States;(b) A felony drug abuse offense, as defined in section 2925.01 of theRevised Code.(5) Maintain a l is t of each person with ownership of the facil ity and notifythe state board of pharmacy of any change to that list.


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PRIME HEALTH MEDICAL SERVICES, INC.c/ o LAlLA GOMAA, M.D.Page 4Notice o f Opportunity

FURTHER, Rule 4729-9-19 of the Ohio Administrative Code states:(A) The state board o f pharmacy may consider as evidence o f a person no tmeeting the requirements provided in sections 4729.53 and 4729.55 ofthe Revised Code, and may deny a person registration as a wholesale

distributor o f dangerous drugs or licensure as a terminal distributor ofdangerous drugs in Ohio i f such person:(1) Has been convicted o f a felony;(2) Has been convicted of violating any state or federal pharmacy ordrug law;(3) Is no t o f good moral character and habits;(4) Is addicted to or abusing liquor or drugs;(5) Has been disciplined by the Ohio state board of pharmacy pursuantto section 4729.16 of the Revised Code; or(6) Has been disciplined by any professional l icensing board.

FURTHER, the State Medical Board o f Ohio has set forth the fol lowinq standards byEmergency Rule in Rule 4731-29-01 of the Ohio Administrative Code:(A) ...(B) In the operation o f a pain management clinic, the followlnqrequirements shall be met:

(l) The pain management cl inic shall be owned and operated by oneor more physicians. Each physician owner of a pain managementclinic shall complete at least twenty hours of category I continuingmedical education in pain medicine every tw o years. The coursescompleted in compliance with this rule shall be accepted towardmeeting the category I requirement fo r certificate of registrationrenewal fo r the physician.(2) Except as provided in paragraph (B)(3) of this rule, the physicianowner of a pain management clinic must meet one of the followingrequirements :

(a) Hold current subspecialty certification in pain managementby the American board o f medical specialties, or hold acurrent certificate of added qualification in pain management


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by the American osteopathic association bureau ofosteopathic specialists; or(b) Hold current subspecialty certification in hospice andpalliative medicine by the American board of medicalspecialties, or hold a current certificate of added qualificationin hospice and palliative medicine by the Americanosteopathic association bureau of osteopathic specialists; or(c) Hold current board cert if ication by the American board ofpain medicine; or(d) Hold current board certi fication by the American board ofinterventional pain physicians.

(3) A physician who applies for a category III terminal distributor ofdangerous drugs with a pain management clinic classification under4729.552 of the Revised Code by June 20, 2011 may own a painmanagement clinic if the medical board determines that all of thefollowing criteria are met :

(a) Meet one of the following requirements:(i) An internship or residency program that wouldsatisfy post-graduate training requirements fo r boardcertification in anesthesiology, psychiatry, neurology,physical medicine and rehabilitation, occupationalmedicine, or rheumatology conducted in the UnitedStates and accredited by either the accreditationcouncil for graduate medical education of the Americanmedical association or the American osteopathicassociation ; or(ll) A clinical fellowship program that would satisfypost-graduate training requirements for boardcertification in anesthesiology, psychiatry, neurology,physical medicine and rehabilitation, occupationalmedicine, or rheumatology, conducted in the UnitedStates at an ins ti tution with a residency programaccredited by either the accreditation council forgraduate medical education of the American medicalassociation or the American osteopathic associationthat is in a clinical field the same as or related to theclinical field of the fellowship program; or


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PRIME HEALTH MEDICAL SERVICES, INC.c/o LAlLA GOMAA, M.D.Page6Notice of Opportunity

(iii) An internship program that would satisfy postgraduate training requirements for board certificationin anesthesiology, psychiatry, neurology, physicalmedicine and rehabil itation, occupational medicine, orrheumatology, conducted in Canada and accredited bythe committee on accreditation of preregistrationphysician training programs of the federation ofprovincial medical licensing authorities of Canada; or(iv) A residency program that would satisfy postgraduate training requirements for board certificationin anesthesiology, psychiatry, neurology, physicalmedicine and rehabil itation, occupational medicine, orrheumatology, conducted in Canada and accredited byeither the royal college of physicians and surgeons ofCanada or the college of family physicians of Canada;or(v) The provision of at least three years of full-timeclinical services, within the last three years, in painmedicine, pain management, hospice and palliativemedicine, addiction psychiatry, physical medicine andrehabilitation, occupational medicine, or rheumatology;or(vi) At least three years of continuous service as aclinical professor or assistant clinical professor, withinthe last three years, in pain medicine, painmanagement, hospice and palliative medicine,addiction psychiatry, physical medicine andrehabil itation, occupational medicine, or rheumatologyat a medical school accredited by the l iaison committeeon medical education or the American osteopathicassociation.

(b) The physician's practice complies with the minimalstandards of care.(i) The physician shall provide a copy of the applicationfor a category III terminal distributor of dangerousdrugs with a pain management clinic classificationunder section 4729.552 of the Revised Code to themedical board.(ll) The copy of the application shall serve as acompla int which shall authorize the medical board to


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investigate the physician's practice pursuant to section4731 .22(F) of the Revised Code.(4) The pain management clinic shall be licensed as a category IIIterminal distributor of dangerous drugs with a pain managementclinic classification under section 4729.552 of the Revised Code.(5) The pain management cl inic shall be operated in compliance withthe drug prevention and control act, 21 U.S.c. 801 et. seq., andchapters 3719., 4729., 4730., and 4731. of the Revised Code.(6) The pain management clinic shall have proper equipment,materials, and personnel on premises to provide appropriate medicaltreatment, as required by the minimal standards of care.

(C) No physician owner of a pain management clinic, employee of the clinic,person with whom the clinic contracts for services shall:(1) Have ever been denied a license to prescribe, dispense,administer, supply, or sell a controlled substance by the drugenforcement administration or appropriate issuing body of any stateor jurisdiction, based, in whole or in part, on the prescriber'sinappropr iate prescribing, dispensing, administering, supplying orselling a controlled substance.(2) Have held a license issued by the drug enforcementadminist ration or a state licensing agency in any jurisdiction, underwhich the person may prescribe, dispense, administer, supply, or sella control led substance, that has ever been restricted, based, inwhole or in part, on the prescriber's inappropriate prescribing,dispensing, administering, supplying, or selling a controlledsubstance.(3) Have been subject to discipl inary action by any l icensing entitythat was based, in whole or in part, on the prescribers inappropriateprescribing, dispensing, diverting, administering, supplying, orselling a controlled substance.

The aforementioned rule, herein referred to as the "Medical Board's EmergencyRule," has been superseded by the followinq, Rule 4731-29-01 of the OhioAdministrative Code, set forth in pertinent part:

(A) ...


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(8) In the operation of a pain management clinic, the following requirementsshall be met:(1) The pain management clinic shall be owned and operated by one ormore physicians. Each physician owner of a pain management clinic shallcomplete at least twenty hours of category I continuing medical educationin pain medicine every two years, to include one or more coursesaddressing the potential fo r addiction. The courses completed incompliance with this rule shall be accepted toward meeting the category Irequirement for certificate of registration renewal for the physician.(2) Each physician owner of a pain management clinic must meet one ofthe following requirements:

(a) Hold current subspecialty certi fication in pain management bythe American board of medical specialties, or hold a currentcertificate of added qualification in pain management by theAmerican osteopathic association bureau of osteopathicspecialists; or(b) Hold current subspecialty certification in hospice and palliat ivemedicine by the American board of medical specialties, or hold acurrent certificate of added quali fication in hospice and palliativemedicine by the American osteopathic association bureau ofosteopathic specialists; or(c) Hold current board certification by the American board of painmedicine ; or(d) Hold current board certification by the American board ofinterventional pain physicians; or(e) Meet both of the following:

(i) Hold current board certification in anesthesiology,psychiatry, neurology, physical medicine and rehabilitation,occupational medicine, or rheumatology by the Americanboard of medical specialties or hold current primarycertification in anesthesiology, psychiatry, neurology,physical medicine and rehabilitation, occupational medicine,or rheumatology by the American osteopathic associationbureau of osteopathic specialists.(ll) Demonstrate conformance with the minimal standards ofcare.


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PRIME HEALTH MEDICAL SERVICES, INC.c/ o LAlLA GOMAA, M.D.Page 9Notice of Opportunity

(D) No physician owner of a pain management clinic, employee of the clinic, orperson with whom the clinic contracts fo r services shall:(1) Have ever been denied a license to prescribe, dispense, administer,supply, or sell a controlled substance by the drug enforcementadministration or appropr iate issuing body of any state or jurisdiction,based, in whole or in part, on the prescriber's inappropriate prescribing,dispensing, administering, supplying or selling a controlled substance orother dangerous drug.(2) Have held a license issued by the drug enforcement administrat ion ora state licensing agency in any jurisdiction, under which the person mayprescribe, dispense, administer, supply or sell a control led substance,that has ever been restricted, based, in whole or in part, on theprescriber's inappropriate prescribing, dispensing, administering,supplying, or selling a controlled substance or other dangerous drug.(3) Have been subject to discipl inary act ion by any l icensing entity thatwas based, in whole or in part, on the prescribers inappropriateprescribing, dispensing, diverting, administering, supplying or sell ing acontrolled substance or other dangerous drug.

YOU ARE FURTHER NOTIFIED, in accordance with the provisions of Chapters 119. and4729. of th e Ohio Revised Code, that you are ent it led to a hearing before the OhioState Board of Pharmacy, if you request such a hearing within thirty (30) days of thetime of the mailing of this notice.IF YOU DESIRE A HEARING, such request shall be mailed to the State Board ofPharmacy, 77 South High Street, Room 1702, Columbus, Ohio 43215-6126. YOURREQUEST MUST BE IN WRITING, AND MUST BE RECEIVED IN THE OFFICE OF THE OHIOSTATE BOARD OF PHARMACY ON OR PRIOR TO THE THIRTIETH (30TH) DAY FOLLOWINGTHE MAILING DATE OF THIS NOTICE. You may appear at such hearing in person, byyour attorney, or by such other representative as is permi tted to practice before theagency, or you may present your posit ion, arguments or contentions in writing; and, atthis hearing, you may also present evidence and examine any witnesses appearing fo rand against you.


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YOU ARE FURTHER ADVISED that i f there is no request fo r such a hearing received bythe Board on or prior to the thirtieth (30 th ) day fol lowing the mailing of this notice, theOhio State Board of Pharmacy, upon consideration of the aforementioned allegationsagainst you, may take action without such a hearing.

BY ORDER OFTHE STATE BOARD OF PHARMACY

-h$L ~ h ~yle . Parker, M.B.A., R.Ph.Executive DirectorKWP/bte (CN 2012 1388)Registered Mail / Return ReceiptRE 946 606 547 USc: Charissa D. Payer, Assistant Attorney General

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Prime Health Med. Svcs. Co. Laila Gomaa, MD. (PD PMC)