Disciplinary Action against Steven Mays, D.O.
Stephen Barrett, M.D.
In 2009, the Texas Medical Board reprimanded Steven Mays, D.O. and ordered him to pay an administrative penalty of $10,000. He is also required to hire a practice monitor for one year, pass an examination in jurisprudence, and take continuing education courses in ethics, recordkeeping, prescribing, and endocrinology (including thyroid disorders). The trouble arose during a 2-year period when he was medical director of a clinic that offered weight loss treatment, thyroid replacement therapy, and bio-identical hormone and/or human growth hormone (HGH) replacement therapy. The agreed order (shown below) states that during this period he (a) was responsible for false advertising statements, (b) failed to meet the standard of care for assessment, diagnosis, treatment, and documentation for twelve patients, and (c) delegated responsibility to unqualified and unlicensed staff members who administered inappropriate tests and treatments.
LICENSE NO. G-4169
IN THE MATTER OF
STEVEN CRAIG MAYS, D.O.
TEXAS MEDICAL BOARD
On the 21 day of August 2009, came on to be heard before the Texas Medical Board (the "Board"), duly in session, the matter of the license of Steven Craig Mays, D.O. ("Respondent")
On June 24, 2009, Respondent appeared in person, with counsel Rosemary L Hollan, at an Informal Show Compliance Proceeding and Settlement Conference in response to a letter of invitation ·\from the staff of the Board. The Board's representatives were Leah R. Mabry, M.D. and Noe Fernandez, both members of a District Review Committee. Sarah Tuthill represented Board staff.
Upon the recommendation of the Board's representatives and with the consent of Respondent, the Board makes the following Findings of Fact and Conclusions· of Law and enters this Agreed Order.
FINDINGS OF FACT
The Board finds that:
1. Respondent received all notice required by law. All jurisdictional requirements have been satisfied. Respondent waives any defect in notice and any further right to notice or hearing under the Medical Practice Act, Title 3, Subtitle B, Texas Occupations Code (the "Act") or the Rules of the Board.
2. Respondent currently holds Texas Medical License No. G-4169. Respondent was originally issued this license to practice medicine in Texas on February 27, 1983. Respondent is not licensed to practice in any other state.
3. Respondent is primarily engaged in the practice of general practice. Respondent is not currently board certified.
4. Respondent is 64 years of age.
5. Respondent has not received a previous disciplinary order from the Board.
6. From approximately November of 2006 to October of 2008, Respondent acted as Medical Director for Natural Bio Health, Incorporated (NBH). NBH's services include weight loss treatment, thyroid replacement therapy, and bio-identical hormone and/or human growth hormone (HGH) replacement therapy.
7. The Board determined that as· Medical Director for NBH, Respondent was responsible for false, misleading, and deceptive advertising statements that claimed positive effects of HGH replacement therapy on diseases such as breast cancer. These misleading advertising statements were disseminated to the public via NBH's website.
8. The Board examined medical records for twelve patients who received care at NBH during Respondent's tenure. Based upon its review of the medical records, the Board determined that Respondent' failed to meet the standard of care in his assessment, diagnosis, treatment, and documentation conducted for all twelve patients.
9. The substandard care delivered to patients was not only a result of Respondent's failure to meet the standard of care, but additionally because Respondent delegated professional medical responsibility and acts to unqualified and unlicensed NBH staff members.
10. Specifically, Respondent allowed an unlicensed managing staff member to conduct initial and follow-up examinations, diagnose patients, and formulate treatment plans, which included the prescription of controlled substances and other prescription-only drugs. Additionally, B-12 injections were at times administered by staff that had little qualification or experience to do so.
11. The unlicensed staff member prescribed controlled substances and other drugs by using pre-signed prescription forms printed with Respondent's signature block. Additionally, the unlicensed staff member purchased controlled substances in his name from an online pharmacy and distributed them to patients. NBH. staff did not keep controlled substance logs or other records of drugs purchased and sold onsite.
12. In each case, the examination methods employed by the unlicensed staff member· were inadequate. The patients' initial evaluations were based largely upon questionnaires designed to detect hormone or thyroid deficiencies that listed vague and non-unique symptoms that could be explained by other conditions.
13. Additionally, lab testing ordered by the staff member was often inappropriate. For example, complete thyroid panels were used to screen for thyroid disease when it is the standard of care to use a thyroid simulating hormone test alone. Patients with no clinical indications or history of diabetes had glucose levels tested.
14. For all patients reviewed, the treatment plans implemented did not meet. the standard of care. Diagnoses made and treatment implemented for weight loss, hormone and thyroid deficiencies were either contraindicated by normal lab-testing results or otherwise unsubstantiated.
15. Once treatment plans were implemented; interval testing and monitoring. was rarely completed for any of the patients involved.
16. Medical records for all twelve patients are disorganized and incomplete, and contain cursory information. Progress notes were inconsistently made and largely unsigned. In several cases reviewed, unidentified NBH staff made notations in the medical record to indicate that normal values were abnorma1, by either circling the results or in one case, writing "low."
17. Respondent either signed off on the evaluations, diagnoses, and treatment prescribed; or treatment plans were noted as being implemented "per doc." Other than these notations, there is little in the record indicating Respondent provided oversight of the treatment plans initiated and administered.
18. Patients receiving contraindicated hormone replacement therapy were required to sign a form indicating knowledge and agreement that the hormone therapy was "elective and not medically necessary" and that the treatment was for "symptomatic improvement and not . . . a medical deficiency." There was nothing in the record' indicating that the patients had been informed of the possible side effects and complications that might occur as a result of HGH or thyroid treatment.
19. In the course of its investigation, the Board determined that Respondent failed to timely update his physician profile information. Since being notified of this issue, Respondent has updated his profile with the Board.
20. Respondent does not admit or deny the Findings 'of Fact and Conclusions of Law set forth in this Agreed Order. However, Respondent has cooperated with Board staff in the investigation of the allegations related to this Agreed Order. Respondent's cooperation, through consent to this Agreed Order,. pursuant to the provisions of Section 164.002 of the Act, will save money and resources for the State of Texas. To avoid further investigation, hearings, and the expense and inconvenience of litigation, Respondent agrees to the entry of this Agreed Order and to comply with its terms and conditions.
CONCLUSIONS OF LAW
Based on the above Findings of Fact, the Board concludes that:
1. The Board has jurisdiction over the subject matter and Respondent pursuant to the Act.
2. Section 164.0S1(a)(1) of the Act authorizes. the Board to take disciplinary 'action against Respondent based on Respondent's commission of an act prohibited under Section 164.052 of the Act.
3. Section 164.051 (a)(3) of the Act authorizes the Board to take disciplinary action against Respondent based on Respondent's violation of a role adopted under this Act, specifically Board Rule(s): 165.1(a), each licensed physician shall maintain an adequate medical record for each patient that is complete, contemporaneous, and legible; 173.3(a), physicians are required to attest as to whether or not the physician's profile information is correct at the time of the physician's registration and to initiate correction of any incorrect information; and 173.3(c), physicians shall. make necessary corrections. and updates' by submitting a profile update and correction form or by submitting it online if completing the registration via the internet.
4. Section' 164.051(a)(6) of the Act authorizes the Board to take disciplinary action against Respondent based on Respondent's failure to practice medicine in an acceptable professional manner consistent with public health and welfare, as further defined by. Board Rule(s): 190.8(1)(A), ,failure to treat a patient according to the generally accepted standard of care; 190.8(1)(C), failure to use proper diligence in one's professional practice; 190.8(1)(D), failure to safeguard against potential complications; 190.8(1)(0), failure to disclose reasonably foreseeable side effects of a procedure .or treatment; and 190.8(1)(L)(i)(II), prescription of any dangerous drug or controlled' substance without first establishing' a proper professional relationship with the patient, which at a minimum requires establishing a· diagnosis through the use of acceptable medical practices such as patient history, mental status examination, physical' examination, and appropriate diagnostic and laboratory testing.
5. Section 164.052(a)(5) of the Act authorizes the Board to take disciplinary action against Respondent based upon Respondent's unprofessional or dishonorable conduct that is likely to deceive or defraud the public or injure the public, as further defined by Board Rule(s): 190.8(2)(I), using false, misleading, or deceptive advertising; and 190.8(2)(J), providing medically unnecessary services to a patient.
6. Section 164.052(a)(6) of the Act authorizes the Board to take disciplinary action· against Respondent based on Respondent using an advertising statement that is false, misleading, or deceptive, as further defined by Board Rule 164.3(4), makes a representation likely to create 4 an unjustified expectation about the results of a health care service or procedure.
7. Section 164~052(a)(17) of the Act authorizes the Board to take disciplinary action against Respondent based on Respondent aiding. or abetting the practice of medicine by any person, partnership, association, or corporation that is not duly licensed to practice medicine by the Board.
8. .Sections 164.052(a)(5) and 164.053(a)(I) of the Act authorize the Board to take disciplinary action against Respondent based on Respondent's ·commission of an act that violates a law of this state that is connected with Respondent's practice of medicine.
9. Sections 164.052(a)(5) and 164.053(a)(2) of the Act authorize the Board to take disciplinary action against Respondent based on' Respondent's failure to keep complete and accurate records of purchases and disposals of drugs listed in Chapter 481, Health and Safety Code; or of controlled substances scheduled in the Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 U.S.C. Section 801 et seq.).
10. Sections 164.052(a)(5) and 164.053(a)(5) of the Act authorizes the Board to take disciplinary action against Respondent based on Respondents’ prescribing or administering a drug or treatment that is nontherapeutic in nature or nontherapeutic in the manner the drug or treatment is administered or prescribed.
11. Sections 164.052(a)(5) and 164.053(a)(6) of the Act authorizes the Board to take disciplinary action against' Respondent. based on Respondent prescribing, administering, or dispensing in a manner inconsistent with public health and welfare, dangerous drugs as defined by Chapter 483, Health and Safety Code; or controlled substances scheduled in Chapter 481 Health and Safety Code; or controlled substances scheduled in. the Comprehensive Drug Abuse Prevention and Control Act of 1970, (21 U.S.C. 3 801 et seq.).
12. Sections 164.052(a)(5) and 164.053(a)(8) of the Act authorize the Board to take disciplinary action against Respondent based on Respondent's failure to supervise adequately the activities of those acting under Respondent's supervision.
13. Section 164.053(a)(9) 'of the Act authorizes the Board to take disciplinary' action against Respondent based on Respondent delegating professional medical responsibility or acts to a person whom Respondent knew or had reason to know was not qualified by training, experience, or licensure to perform the responsibility or acts.
14. Section 164.001 of the Act authorizes the Board to impose a range of disciplinary actions against a person for violation of the Act or a Board rule. Such sanctions include: revocation, suspension, probation, public reprimand, limitation' or restriction on practice, counseling or treatment, required educational or counseling programs, monitored practice, public service, and an administrative penalty.
15. Section 164.002(a) of the Act authorizes the Board to resolve and make a disposition of this matter through an Agreed Order.
16. Section 164.002(d) of the Act provides that this Agreed Order is a settlement agreement under the Texas Rules of Evidence for purposes of civil litigation.
Based on the above Findings of Fact and Conclusions of' Law, the Board ORDERS that Respondent shall be subject to the following terms and conditions for the period of one year:
1. This Agreed Order shall constitute a PUBLIC REPRIMAND of Respondent, and Respondent is hereby reprimanded.
2. Within one year following the date of the entry of this Order, Respondent shall take and pass with a score of 75 or above the Medical Jurisprudence Examination ("JP Exam") given by the Texas Medical Board. Respondent is allowed three attempts to successfully pass this examination
Respondent's failure to take and pass the JP Exam within three attempts within one year following the date of the entry of this Order shall constitute a violation of this Agreed Order.
After a committee of the Board or a panel of Board representatives (Board Representatives), has considered the information related to Respondent's violation of this provision and has determined that Respondent has not fulfilled the requirements of this provision, Respondent's medical license shall be IMMEDIATELY SUSPENDED pursuant to correspondence to Respondent from the Executive Director or Secretary-Treasurer of the Board indicating that Board Representatives have considered the information related to Respondent's violation of this provision and have determined that Respondent has not fulfilled the requirements of this provision. Although Respondent shall be invited to provide information or testimony to the Board Representatives, Respondent specifically waives any administrative due process under the Medical Practice Act, or the Administrative Procedure Act, for the Board Representatives to consider this information. THIS SUSPENSION SHALL BE EFFECTIVE WITHOUT THE NEED FOR A HEARING AT THE STATE OFFICE OF ADMINISTRATIVE HEARINGS OR OTHER ADMINISTRATIVE DUE PROCESS UNDER THE MEDICAL PRACTICE ACT OR THE ADMINISTRATIVE· PROCEDURE ACT, AND RESPONDENT SPECIFICALLY WAIVES ANY SUCH HEARING OR DUE PROCESS AND ALL RIGHTS OF APPEAL. Respondent shall be notified of any suspension by certified mail, return receipt requested to Respondent's last known address on file with the Board. If Respondent's license is suspended on such a basis, the suspension shall remain in effect until such time as Respondent takes and passes the JP Exam and subsequently appears before the Board in person and provides sufficient evidence which, in the discretion of the Board, is adequate to show that Respondent possesses the skills and knowledge to safely practice in Texas and is otherwise physically and mentally competent to resume the practice in this state.
3. While under the terms of this Order, Respondent's practice shall be monitored by a physician ("monitor"), in accordance with § 164.001 (b)(7) of the Act. The Compliance Division of the Board shall designate the monitor and may change the monitor at any time for any reason. Division shall provide a copy of this Order to the monitor, together with' other. information necessary to assist the monitor.
a. As requested by the Compliance Division, Respondent shall prepare and provide complete legible copies of selected patient medical and billing records ("selected records"). The Compliance Division shall select records for at least 30 patients seen by Respondent during each three-month· period following the last day of the month of entry of this Order ("reporting period"). The Compliance Division may select records for more than 39 patients, up to 10 percent of the patients seen during a reporting period. If Respondent fails to see at least 30 patients during any three-month period, the term of this Order shall be extended until Respondent can submit a sufficient number of records for a monitor to review.
b. The monitor shall perform the following duties:
1) Personally review the selected records;
2) Prepare written reports documenting any perceived deficiencies and any recommendations to improve Respondent's practice of medicine or assist in the ongoing monitoring process. Reports shall be submitted as requested by the Compliance Division; and
3) Perform any other duty that the Compliance Division determines will assist the effective monitoring of Respondent's practice.
c. The Compliance Division shall provide to Respondent a copy of any deficiencies or recommendations submitted by the monitor. Respondent shall implement the recommendations as directed by the Compliance Division.
d. The monitor shall be· the agent· of the Board, but shall be compensated by the Respondent through the Board. Such compensation and any costs incurred by the monitor shall be paid by Respondent to the Board and remitted by the Board to the monitor. Respondent shall not change the compensation and costs paid to the monitor to any patients.
4. Within one year from the date of the entry of this Order, Respondent shall enroll in and successfully complete at least 30 hours of continuing medical education (CME), to be divided accordingly:
a. At least. 10 hours of CME in the subject area of medical record-keeping, approved for Category I credits by the American Medical Association;
b. At least 10 hours of CME in the subject area of prescribing for family medicine practice, approved for Category I credits by the American Medical Association.
c. At least five hours of CME in the subject area of endocrinology, which must include the subject of thyroid disorders, approved for Category I credits by the American Medical Association; and
d. At least five hours of CME in the subject area of ethics, approved for Category I credits by the American Medical Association.
5. For all CME required by this Order, Respondent shall obtain approval for each course in writing and in advance by the Board. To obtain approval for each course, Respondent shall submit in writing to the Board information that includes at least a reasonably detailed description of the course content and faculty, as well as the course location and, dates of instruction. Respondent shall submit documentation of attendance and successful completion of all CME requirements· to the Board on or before the expiration of the time limit set forth for completion of each course. The CME requirements set forth in this Order shall be in addition to all other CME required for licensure maintenance.
6. Respondent shall pay an administrative penalty in the amount of $10,000 within 180 days of the date of the entry of this Order. The administrative penalty shall be paid in a single payment by cashier's check or money order payable to the Texas Medical Board and shall be submitted to the Board for routing so as to be remitted to the Comptroller of Texas for deposit in the general revenue fund. Respondent's failure to. pay the administrative penalty as ordered shall constitute grounds for further disciplinary action by the Board, and may result in a referral by the Executive Director of the Board for collection by the Office of the Attorney General.
7. The time period of this Order shall be extended for any period of time that: (a) Respondent subsequently practices exclusively outside the State of Texas; (b) Respondent's license is subsequently cancelled for nonpayment of licensure fees; (c) this Order is stayed or enjoined by Court Order; or (d) for any period of time longer than 60 consecutive days that Respondent does not actively practice medicine. If Respondent leaves. Texas to practice elsewhere or ceases active practice for more than 60 consecutive days,' Respondent shall immediately notify the Board in writing. Upon Respondent's return to active practice or return to practice in Texas, Respondent shall notify the Board in writing. When the period of extension ends, Respondent shall be required to comply with the terms of this Order for the period of time remaining on the Order. Respondent shall pay all fees for reinstatement or renewal of a license covering the period of extension or tolling.
8. Respondent shall comply with all the provisions of the Act and other statutes regulating the Respondent's practice.
9. Respondent shall fully cooperate with the Board and the Board staff, including Board attorneys, investigators, compliance officers, consultants, and other employees or agents of the Board in any way involved in investigation, review, or monitoring associated· with Respondent's compliance with this Order. Failure to fully cooperate shall .constitute a violation of this order and a basis for disciplinary action against Respondent pursuant to the Act .
10. Respondent shall inform the Board in writing of any change of Respondent's office or mailing address within 10 days of the address change. This information shall be submitted to the Registration Department and the Compliance Department of the Board. Failure to provide such information in a timely manner shall constitute a basis for disciplinary action by the Board against Respondent pursuant to the Act. Respondent agrees that 10 days notice of a Probationer Show Compliance Proceeding to address any allegation of non-compliance of this Agreed Order is adequate and reasonable notice prior to the initiation of formal disciplinary action. Respondent waives the 3D-day notice requirement provided by § 164.003(b)(2) of the Medical Practice Act and agrees to 10 days notice, as provided in 22 Texas Administrative Code §187.44(4).
11. Any violation of the terms, conditions, or requirements of this Order by Respondent shall constitute unprofessional conduct likely to deceive or defraud the public, or to injure the public, and shall constitute a basis for disciplinary action by the Board against Respondent pursuant to the Act.
12. This Agreed Order constitutes a restriction on Respondent's license and Respondent shall not be permitted to supervise or delegate prescriptive authority to a physician assistant or advanced practice nurse or supervise a surgical assistant.
RESPONDENT WAIVES ANY FURTHER HEARINGS OR APPEALS TO THE BOARD OR TO ANY COURT IN REGARD TO ALL TERMS .AND CONDITIONS OF THIS AGREED ORDER. RESPONDENT AGREES THAT THIS IS A FINAL ORDER.
THIS ORDER IS A PUBLIC RECORD.
I, STEVEN CRAIG MAYS, D.O., HAVE READ AND UNDERSTAND THE FOREGOING AGREED ORDER. I UNDERSTAND THAT BY SIGNING, I WAIVE CERTAIN RIGHTS. I SIGN IT VOLUNTARILY. I UNDERSTAND THIS' AGREED ORDER CONTAINS THE ENTIRE AGREEMENT AND THERE IS NO OTHER AGREEMENT OF ANY KIND, VERBAL, WRITTEN OR OTHERWISE.
DATED: August 3, 2009.
STEVEN CRAIG MAYS, D.O.
SIGNED·AND ENTERED by the presiding officer of the Texas Medical Board on this 21 day of August, 2009.
Irvin E. Zeitler, Jr., D.O., President
Texas Medical. Board
This page was posted on November 30, 2009.