OHIO STATE BOARD OF PHARMACY

77 South High Street, Room 1702; Columbus, OH 43215-6126

-Equal Opportunity Employer and Service Provider-

TEL: 614/466-4143

TTY/TDD: Use the Ohio Relay Service: 1-800/750-0750

E-MAIL: exec@bop.state.oh.us FAX: 6141752-4836 URL: http://www.pharmacy.ohio.gov

PROPOSAL TO DENY!NOTICE OF OPPORTUNITY FOR HEARING

April 29, 2013

John B. Beyer, M.D.

C/O john B. Beyer, M.D. 3974 Karl Rd. Columbus, OH 43224 Re: Application for Registration as a Terminal Distributor of Dangerous Drugs with a Pain Management Clinic Classification

Dear Mr. Beye r: YOU ARE HEREBY NOTIFIED, in accordance with the provisions of Section 119.07 of the Revised Code, that your application for registration as a Terminal Distributor of Dangerous Drugs with a Pain Management Clinic Classification pursuant to Sections 4729.54 and 4729.552 of the Revised Code has been proposed to be denied. The reason for this proposal is that the Board has evidence which leads it to believe that you do not qualify for registration under Sections 4729.55 or 4729.552 of the Revised Code. Specifically, you have not furnished satisfactory proof to the Board that you meet the qualifications enumerated therein and pursuant to rule. The specific evidence in support of this action is as follows:
(l)

Records of the Board of Pharmacy indicate that on or about june 27, 2011, you were the Responsible Person and Owner for john B. Beyer, M.D., 3974 Karl Rd., Columbus, OH 43224, and that on june 27, 2011, john B. Beyer, M.D. applied for registration as a Terminal Distributor of Dangerous Drugs with a Pain Management Clinic Classification. The Owner and sole operator of the offices of john B. Beyer, M.D. has failed to furnish satisfactory proof to the Board that he shall be in control of the facility that is owned and operated solely by one or more physicians authorized under Chapter 4731. of the Revised Code to practice medicine and surgery or osteopathic medicine and surgery. Specifically, on or around February 13, 2013 Mr. Beyer permanently surrendered his certificate to practice medicine and surgery in the State of Ohio, such surrender to become effective March 16, 2013. Such conduct is contrary to Sections 4729.55 and 4729.552 of the Ohio Revised Code, effective May 20,2011, and Emergency Rule 4731-29-01 and Rule 4729-919 of the Ohio Administrative Code.

(2)

John B. Beyer, M.D. c/o John B. Beyer, M.D. Page 2 Notice of Opportunity

YOU ARE HEREBY ADVISED that Section 4729.55 of the Ohio Revised Code provides in pertinent part that: No license shall be issued to an applicant for licensure as a terminal distributor of dangerous drugs unless the applicant has furnished satisfactory proof to the board of pharmacy that: (A) The applicant is equipped as to land, buildings, and equipment to properly carryon the business of a terminal distributor of dangerous drugs within the category of licensure approved by the board. (B) A pharmacist, licensed health professional authorized to prescribe drugs, animal shelter licensed with the state board of pharmacy under section 4729.531 of the Revised Code, or a laboratory as defined in section 3719.01 of the Revised Code will maintain supervision and control over the possession and custody of dangerous drugs that may be acquired by or on behalf of the applicant. (C) Adequate safeguards are assured to prevent the sale or other distribution of dangerous drugs by any person other than a pharmacist or licensed health professional authorized to prescribe drugs. (D) Adequate safeguards are assured that the applicant will carry on the business of a terminal distributor of dangerous drugs in a manner that allows pharmacists and pharmacy interns employed by the terminal distributor to practice pharmacy in a safe and effective manner. (E) If the applicant, or any agent or employee of the applicant, has been found guilty of violating section 4729.51 of the Revised Code, the "Federal Food, Drug, and Cosmetic Act," 52 Stat. 1040 (1938), 21 U.S.c.A. 301, the federal drug abuse control laws, Chapter 2925., 3715., 3719., or 4729. of the Revised Code, or any rule of the board, adequate safeguards are assured to prevent the recurrence of the violation.

U) In the case of an applicant who is a pain management clinic, the applicant meets the requirements to receive a license with a pain management clinic classification issued under section 4729.552 of the Revised Code.

John B. Beyer, M.D. c/o John B. Beyer, M.D. Page 3 Notice of Opportunity

YOU ARE FURTHER ADVISED that Section 4729.552 of the Ohio Revised Code provides in pertinent part that:

(A) To be eligible to receive a license as a category III terminal distributor of dangerous drugs with a pain management clinic classification, an applicant shall submit evidence satisfactory to the board that the applicant's pain management clinic will be operated in accordance with the requirements specified in division (B) of this section and that the applicant meets any other applicable requirements under this chapter or Chapter 3719. of the Revised Code.

(B) The holder of a terminal distributor license with a pain management clinic classification shall do all of the following:
(l) Be in control of a facility that is owned and operated solely by one or more physicians authorized under Chapter 4731. of the Revised Code to practice medicine and surgery or osteopathic medicine and surgery;

(2) Ensure that any person employed by the facility complies with the requirements for the operation of a pain management clinic established by the state medical board in rules adopted under section 4731.054 of the Revised Code; (3) Require any person with ownership of the facility to submit to a criminal records check in accordance with section 4776.02 of the Revised Code and send the results of the criminal records check directly to the state board of pharmacy for review and decision under section 4729.071 of the Revised Code; (4) Require all employees of the facility to submit to a criminal records check in accordance with section 4776.02 of the Revised Code and ensure that 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 the Revised 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 the Revised Code.

John B. Beyer, M.D. c/o John B. Beyer, M.D. Page 4 Notice of Opportunity

(5) Maintain a list of each person with ownership of the facility and notify the state board of pharmacy of any change to that list. FURTHER, Rule 4729-9-19 of the Ohio Administrative Code states: (A) The state board of pharmacy may consider as evidence of a person not meeting the requirements provided in sections 4729.53 and 4729.55 of the Revised Code, and may deny a person registration as a wholesale distributor of dangerous drugs or licensure as a terminal distributor of dangerous drugs in Ohio if such person: (1) Has been convicted of a felony; (2) Has been convicted of violating any state or federal pharmacy or drug law; (3) Is not of 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 pursuant to section 4729.16 of the Revised Code; or (6) Has been disciplined by any professional licensing board. FURTHER, the State Medical Board of Ohio has set forth the followinq standards by Emergency Rule in Rule 4731-29-01 of the Ohio Administrative Code:
(A) ...

(B) In the operation of a pain requirements shall be met:

management clinic,

the

followlnq

(1) The pain management clinic shall be owned and operated by one or more physicians. Each physician owner of a pain management clinic shall complete at least twenty hours of category I continuing medical education in pain medicine every two years. The courses completed in compliance with this rule shall be accepted toward meeting the category I requirement for certificate of registration renewal for the physician. (2) Except as provided in paragraph (B)(3) of this rule, the physician owner of a pain management clinic must meet one of the following requirements:

John B. Beyer, M.D. c/o John B. Beyer, M.D. Page 5 Notice of Opportunity

(a) Hold current subspecialty certification in pain management by the American board of medical specialties, or hold a current certificate of added qualification in pain management by the American osteopathic association bureau of osteopathic specialists; or (b) Hold current subspecialty certification in hospice and palliative medicine by the American board of medical specialties, or hold a current certificate of added qualification in hospice and palliative medicine by the American osteopathic association bureau of osteopathic specialists; or (c) Hold current board certification by the American board of pain medicine; or (d) Hold current board certification by the American board of interventional pain physicians. (3) A physician who applies for a category III terminal distributor of dangerous drugs with a pain management clinic classification under 4729.552 of the Revised Code by June 20, 2011 may own a pain management clinic if the medical board determines that all of the following criteria are met: (a) Meet one of the following requirements:
(i) An internship or residency program that would

satisfy post-graduate training requirements for board certification in anesthesiology, psychiatry, neurology, physical medicine and rehabilitation, occupational medicine, or rheumatology conducted in the United States and accredited by either the accreditation council for graduate medical education of the American medical association or the American osteopathic association; or (ll) A clinical fellowship program that would satisfy for board post-graduate training requirements certification in anesthesiology, psychiatry, neurology, physical medicine and rehabilitation, occupational medicine, or rheumatology, conducted in the United States at an institution with a residency program accredited by either the accreditation council for graduate medical education of the American medical association or the American osteopathic association

John B. Beyer, M.D. c/o John B. Beyer, M.D. Page 6 Notice of Opportunity

that is in a clinical field the same as or related to the clinical field of the fellowship program; or (iii) An internship program that would satisfy postgraduate training requirements for board certification in anesthesiology, psychiatry, neurology, physical medicine and rehabilitation, occupational medicine, or rheumatology, conducted in Canada and accredited by the committee on accreditation of preregistration physician training programs of the federation of provincial medical licensing authorities of Canada; or (iv) A residency program that would satisfy postgraduate training requirements for board certification in anesthesiology, psychiatry, neurology, physical medicine and rehabilitation, occupational medicine, or rheumatology, conducted in Canada and accredited by either the royal college of physicians and surgeons of Canada or the college of family physicians of Canada; or (v) The provision of at least three years of full-time clinical services, within the last three years, in pain medicine, pain management, hospice and palliative medicine, addiction psychiatry, physical medicine and rehabilitation, occupational medicine, or rheumatology; or (vi) At least three years of continuous service as a clinical professor or assistant clinical professor, within the last three years, in pain medicine, pain management, hospice and palliative medicine, addiction psychiatry, physical medicine and rehabilitation, occupational medicine, or rheumatology at a medical school accredited by the liaison committee on medical education or the American osteopathic association. (b) The physician's practice complies with the minimal standards of care. (i) The physician shall provide a copy of the application for a category III terminal distributor of dangerous drugs with a pain management clinic classification under section 4729.552 of the Revised Code to the medical board.

John B. Beyer, M.D. c/o John B. Beyer, M.D. Page 7 Notice of Opportunity

(il) The copy of the application shall serve as a complaint which shall authorize the medical board to investigate the physician's practice pursuant to section 4731.22(F) of the Revised Code. (4) The pain management clinic shall be licensed as a category III terminal distributor of dangerous drugs with a pain management clinic classification under section 4729.552 of the Revised Code. (5) The pain management clinic shall be operated in compliance with the drug prevention and control act, 21 U.s.c. 801 et. seq., and chapters 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 medical treatment, 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 drug enforcement administration or appropriate 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. (2) Have held a license issued by the drug enforcement administration or a state licensing agency in any jurisdiction, under which the person may prescribe, dispense, administer, supply, or sell a controlled substance, that has ever been restricted, based, in whole or in part, on the prescriber's inappropriate prescribing, dispensing, administering, supplying, or selling a controlled substance. (3) Have been subject to disciplinary action by any licensing entity that was based, in whole or in part, on the prescribers inappropriate prescribing, dispensing, diverting, administering, supplying, or selling a controlled substance.

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

John B. Beyer, M.D. c/o John B. Beyer, M.D. Page 8 Notice of Opportunity

(A) ...

(B) In the operation of a pain management clinic, the following requirements shall be met: (1) The pain management clinic shall be owned and operated by one or more physicians. Each physician owner of a pain management clinic shall complete at least twenty hours of category I continuing medical education in pain medicine every two years, to include one or more courses addressing the potential for addiction. The courses completed in compliance with this rule shall be accepted toward meeting the category I requirement for certificate of registration renewal for the physician. (2) Each physician owner of a pain management clinic must meet one of the following requirements: (a) Hold current subspecialty certification in pain management by the American board of medical specialties, or hold a current certificate of added qualification in pain management by the American osteopathic association bureau of osteopathic specialists; or (b) Hold current subspecialty certification in hospice and palliative medicine by the American board of medical specialties, or hold a current certificate of added qualification in hospice and palliative medicine by the American osteopathic association bureau of osteopathic specialists; or (c) Hold current board certification by the American board of pain medicine; or (d) Hold current board certification by the American board of interventional 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 American board of medical specialties or hold current primary certification in anesthesiology, psychiatry, neurology, physical medicine and rehabilitation, occupational medicine,

John B. Beyer, M.D.

c/o John B. Beyer, M.D. Page 9 Notice of Opportunity

or rheumatology by the American osteopathic association bureau of osteopathic specialists. (ii) Demonstrate conformance with the minimal standards of care.

(D) No physician owner of a pain management clinic, employee of the clinic, or person with whom the clinic contracts for services shall:
(l) Have ever been denied a license to prescribe, dispense, administer, supply, or sell a controlled substance by the drug enforcement administration or appropriate 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 or other dangerous drug.

(2) Have held a license issued by the drug enforcement administration or a state licensing agency in any jurisdiction, under which the person may prescribe, dispense, administer, supply or sell a controlled substance, that has ever been restricted, based, in whole or in part, on the prescriber's inappropriate prescribing, dispensing, administering, supplying, or selling a controlled substance or other dangerous drug. (3) Have been subject to disciplinary action by any licensing entity that was based, in whole or in part, on the prescribers inappropriate prescribing, dispensing, diverting, administering, supplying or selling a controlled substance or other dangerous drug.

YOU ARE FURTHER NOTIFIED, in accordance with the provisions of Chapters 119. and 4729. of the Ohio Revised Code, that you are entitled to a hearing before the Ohio State Board of Pharmacy, if you request such a hearing within thirty (30) days of the time of the mailing of this notice. IF YOU DESIRE A HEARING, such request shall be mailed to the State Board of Pharmacy, 77 South High Street, Room 1702, Columbus, Ohio 43215-6126. YOUR REQUEST MUST BE IN WRITING, AND MUST BE RECEIVED IN THE OFFICE OF THE OHIO STATE BOARD OF PHARMACY ON OR PRIOR TO THE THIRTIETH (30 TH) DAY FOLLOWING THE MAILING DATE OF THIS NOTICE. You may appear at such hearing in person, by your attorney, or by such other representative as is permitted to practice before the agency, or you may present your position, arguments or contentions in writing; and, at this hearing, you may also present evidence and examine any witnesses appearing for and against you.

John B. Beyer, M.D. c/o John B. Beyer, M.D. Page 10 Notice of Opportunity

YOU ARE FURTHER ADVISED that if there is no request for such a hearing received by the Board on or prior to the thirtieth (30 th) day following the mailing of this notice, the Ohio State Board of Pharmacy, upon consideration of the aforementioned allegations against you, may take action without such a hearing.

BY ORDER OF THE STATE BOARD OF PHARMACY

KWP/bte (eN 2012-1509 ) Registered Mail/Return Receipt RE 946 606 459 US

c:

Alan P. Schwepe, Assistant Attorney General