TITLE 22.EXAMINING BOARDS

Part 9. TEXAS MEDICAL BOARD

Chapter 163. LICENSURE

The Texas Medical Board proposes amendments to §§163.1, 163.2, 163.4, 163.6 and the repeal of 163.12, concerning Licensure.

The amendment to §163.1 allows payment of fees on-line and makes minor clean-up changes. The amendment to §163.2 creates an alternative opportunity for licensure for applicants who have graduated from a foreign medical school that has not been approved as substantially equivalent to a U.S. or Canadian medical school or that has been disapproved by another state licensing board and reorganizes provisions for fifth pathway to licensure. The amendment to §163.4 authorizes the Executive Director to issue licenses to applicants who clearly qualify for licensure as authorized by provisions of SB 419. The amendment to §163.6 is necessary for minor clean-up of language. Section 163.12 is repealed in order to reorganize the chapter and include all provisions for licensure of foreign medical school graduates in the same section.

Michele Shackelford, General Counsel, Texas Medical Board, has determined that for the first five-year period the amendments and repeal are in effect there will be no fiscal implications to state or local government as a result of enforcing the sections as proposed. There will be no effect to individuals required to comply with the sections as proposed.

Ms. Shackelford also has determined that for each year of the first five years the sections as proposed are in effect the public benefit anticipated as a result of enforcing the sections will be updating rule to allow for on-line payment of fees, allowing for licensure of more qualified graduates of foreign medical schools to increase the number of physicians in Texas, expediting licensure of physicians who clearly meet all licensure requirement and makes the process more efficient and making the rules more understandable. There will be no effect on small or micro businesses.

Comments on the proposal may be submitted to Sally Durocher, P.O. Box 2018, Austin, Texas 78768-2018. A public hearing will be held at a later date.

22 TAC §§163.1, 163.2, 163.4, 163.6

The amendments are proposed under the authority of the Texas Occupations Code Annotated, §153.001, which provides the Texas Medical Board to adopt rules and bylaws as necessary to: govern its own proceedings; perform its duties; regulate the practice of medicine in this state; enforce this subtitle; and establish rules related to licensure.

The following statutes, articles or codes are affected by this proposal: §155.004, §155.002(b), Texas Occupations Code.

§163.1.Definitions.

The following words and terms, (concerning General Definitions) when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise.

(1) - (4) (No change.)

(5) Application--An application is all documents and information necessary to complete an applicant's request for licensure including the following:

(A) forms furnished by the board, completed by the applicant:

(i) all forms and addenda requiring a written response must be typed , [ or ] printed in ink , or completed online ;

(ii) (No change.)

(B) (No change.)

(C) the required fee[ , payable by check through a United States bank ].

(6) - (8) (No change.)

(9) Good professional character--An applicant for licensure must not be in violation of or have committed any act described in the Medical Practice Act, TEX. OCC. CODE ANN. §§164.051-.053.

(10) - (12) (No change.)

(13) Texas Medical Jurisprudence Examination (JP exam): the ethics examination developed by the board [ for licensure that must be passed by an applicant for licensure within three attempts with a score 75 or better ].

(14) (No change.)

§163.2.Full Texas Medical License.

(a) [ United States/Canadian Medical School ] Graduates of medical schools in the United States or Canada . To be eligible for full licensure, an applicant who is a graduate from a school in the United States or Canada must:

(1) - (6) (No change.)

(7) pass the Texas Medical Jurisprudence Examination [ with a score of 75 or better within three attempts ].

(b) Graduates of medical schools outside the United States or Canada [ Acceptable Unapproved Medical Schools ]. To be eligible for full licensure, an applicant who is a graduate from a school outside the United States or Canada must:

(1) - (3) (No change.)

(4) be a graduate of :

(A) an acceptable unapproved medical school as defined under §163.1(2) of this title; or

(B) any medical school and:

(i) have passed the basic sciences portion of an acceptable examination listed in §163.6(a) of this title within two attempts;

(ii) have not been the subject of disciplinary action by any other state, the uniformed services of the United States, or the applicant's peers in a local, regional, state, or national professional medical association or staff of a hospital;

(iii) have, on a full-time basis, actively diagnosed or treated persons or have been on the active teaching faculty of an acceptable approved medical school for three of the last four years preceding receipt of an Application for licensure, which may include post-graduate training (The term "full-time basis" shall have the same meaning provided in §163.11(b) of this title); and

(iv) hold a certificate from a specialty board that is a member of the American Board of Medical Specialties or the Bureau of Osteopathic Specialists or have passed a monitored examination leading to such certification by the specialty board.

(5) - (6) (No change.)

(7) pass the Texas Medical Jurisprudence Examination [ with a score of 75 or better within three attempts ];

(8) - (11) (No change.)

(c) Fifth Pathway Program. To be eligible for licensure, an applicant who has completed a Fifth Pathway Program must:

(1) be at least 21 years of age;

(2) be of good professional character as defined under §163.1(9) of this title;

(3) have completed 60 semester hours of college courses as defined under §163.1(12) of this title;

(4) have completed all of the didactic work, but not graduated from a foreign medical school and meet the requirements subparagraph A or B of this subsection.

(A) The medical school's curriculum meets the requirements for an acceptable unapproved medical school as determined by a committee of experts selected by the Texas Higher Education Coordinating Board; or

(B) Either:

(i) the medical school's curriculum is substantially equivalent to a Texas medical school as defined under §163.1(13) of this title and has not been disapproved by another state physician licensing agency unless the applicant can provide evidence that the disapproval was unfounded, or:

(ii) the applicant must:

(I) have passed the basic sciences portion of an acceptable examination listed in §163.6(a) of this title within two attempts;

(II) have not been the subject of disciplinary action by any other state, the uniformed services of the United States, or the applicant's peers in a local, regional, state, or national professional medical association or staff of a hospital;

(III) have, on a full-time basis, actively diagnosed or treated persons or have been on the active teaching faculty of an acceptable approved medical school for three of the last fours years preceding receipt of an Application for licensure, which may include post-graduate training (The term "full-time basis" shall have the same meaning provided in §163.11(b) of this title); and

(IV) hold a certificate from a specialty board that is a member of the American Board of Medical Specialties or the Bureau of Osteopathic Specialists or have passed a monitored examination leading to such certification by the specialty board.

(5) have successfully completed a three-year training program of graduate medical education in the United States or Canada that was approved by the board on the date the training was completed;

(6) submit evidence of passing an examination, that is acceptable to the board for licensure;

(7) pass the Texas Medical Jurisprudence Examination;

(8) submit a sworn affidavit that no proceedings, past or current, have been instituted against the applicant before any state medical board, provincial medical board, in any military jurisdiction or federal facility;

(9) have attained a passing score on the ECFMG examination;

(10) have the ability to communicate in the English language;

(11) have attained a satisfactory score on a qualifying examination and have completed one academic year of supervised clinical training for foreign medical students as defined by the American Medical Association Council on Medical Education (Fifth Pathway Program) in a United States medical school; and

(12) have supplied all additional information that the board may require, concerning the applicant's medical school, before approving the applicant.

§163.4.Procedural Rules for Licensure Applicants.

(a) - (c) (No change.)

(d) If the Executive Director determines that the applicant clearly meets all licensing requirements, the Executive Director or a person designated by the Executive Director, may issue a license to the applicant, to be effective on the date issued without formal board approval, as authorized by §155.002(b) of the Act.

(e) If the Executive Director determines that the applicant does not clearly meet all licensing requirements, a license may be issued only upon action by the board following a recommendation by the Licensure Committee, in accordance with §155.007 of the Act and §187.13 of this title.

§163.6.Examinations Accepted for Licensure.

(a) - (e) (No change.)

(f) Texas Medical Jurisprudence Examination (JP Exam) [ JP Exam ].

(1) In this chapter, when applicants are required to pass the JP exam, [ In addition to the licensing examinations required for licensure under subsection (a) of this section, ] applicants must pass the JP exam with a score of 75 or better within three attempts.

(2) An examinee shall not be permitted to bring medical books, compendia [ compends ], notes, medical journals, calculators or other help into the examination room, nor be allowed to communicate by word or sign with another examinee while the examination is in progress without permission of the presiding examiner, nor be allowed to leave the examination room except when so permitted by the presiding examiner.

(3) - (4) (No change.)

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on April 17, 2006.

TRD-200602197

Donald W. Patrick, MD, JD

Executive Director

Texas Medical Board

Earliest possible date of adoption: May 28, 2006

For further information, please call: (512) 305-7016


22 TAC §163.12

(Editor's note: The text of the following section proposed for repeal will not be published. The section may be examined in the offices of the Texas Medical Board or in the Texas Register office, Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)

The repeal is proposed under the authority of the Texas Occupations Code Annotated, §153.001, which provides the Texas Medical Board to adopt rules and bylaws as necessary to: govern its own proceedings; perform its duties; regulate the practice of medicine in this state; enforce this subtitle; and establish rules related to licensure.

No other statutes, articles or codes are affected by this proposal.

§163.12.Licensure for the Fifth Pathway.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on April 17, 2006.

TRD-200602198

Donald W. Patrick, MD, JD

Executive Director

Texas Medical Board

Earliest possible date of adoption: May 28, 2006

For further information, please call: (512) 305-7016


Chapter 165. MEDICAL RECORDS

22 TAC §165.1, §165.6

The Texas Medical Board proposes an amendment to §165.1 and new §165.6 concerning Medical Records.

The amendment to §165.1 adds requirements that written consents for treatment or surgery be included in a patient's medical records. New §165.6 provides a form for parental consent for an abortion to be performed on an unemancipated minor, as required by SB 419.

Michele Shackelford, General Counsel, Texas Medical Board, has determined that for the first five-year period the amendment and new section are in effect there will be no fiscal implications to state or local government as a result of enforcing the sections as proposed. There will be no effect to individuals required to comply with the sections as proposed.

Ms. Shackelford also has determined that for each year of the first five years the sections as proposed are in effect the public benefit anticipated as a result of enforcing the sections will be to assure the public that their consent to medical treatment and surgery will be included in their medical records and to provide a standard form for parental consent for an abortion. There will be no effect on small or micro businesses.

Comments on the proposal may be submitted to Sally Durocher, P.O. Box 2018, Austin, Texas 78768-2018. A public hearing will be held at a later date.

The amendment and new section are proposed under the authority of the Texas Occupations Code Annotated, §153.001, which provides the Texas Medical Board to adopt rules and bylaws as necessary to: govern its own proceedings; perform its duties; regulate the practice of medicine in this state; enforce this subtitle; and establish rules related to licensure.

The following statutes, articles or codes are affected by this proposal: §164.052(c), Texas Occupations Code.

§165.1.Medical Records.

(a) Contents of Medical Record. Each licensed physician of the board shall maintain an adequate medical record for each patient that is complete, contemporaneous and legible. For purposes of this section, an "adequate medical record" should meet the following standards:

(1) - (6) (No change.)

(7) any written consents for treatment or surgery requested from the patient/family by the physician.

(8) [ (7) ] Billing codes, including CPT and ICD-9-CM codes, reported on health insurance claim forms or billing statements should be supported by the documentation in the medical record.

(9) [ (8) ] Any amendment, supplementation, change, or correction in a medical record not made contemporaneously with the act or observation shall be noted by indicating the time and date of the amendment, supplementation, change, or correction, and clearly indicating that there has been an amendment, supplementation, change, or correction.

(10) [ (9) ] Records received from another physician or health care provider involved in the care or treatment of the patient shall be maintained as part of the patient's medical records.

(11) [ (10) ] The board acknowledges that the nature and amount of physician work and documentation varies by type of services, place of service and the patient's status. Paragraphs (1) - (11) [ (10) ] of this subsection may be modified to account for these variable circumstances in providing medical care.

(b) (No change.)

§165.6.Medical Records Regarding an Abortion on an Unemancipated Minor.

(a) As used in this section:

(1) "Abortion" means the use of any means to terminate the pregnancy of a female known by the attending physician to be pregnant with the intention that the termination of the pregnancy by those means will, with reasonable likelihood, cause the death of the fetus (as defined at §33.001, Texas Family Code).

(2) "Unemancipated minor" means a minor who is not 18 years, unmarried and has not had the disabilities of minority removed under Chapter 31, Texas Family Code (as defined at §33.001, Texas Family Code).

(b) In the case of an unemancipated minor patient on whom a physician plans to perform an abortion, the physician shall obtain and maintain in the medical records one of the following:

(1) the written consent of one of the patient's parents, managing conservator, or legal guardian, in accordance with §164.052(a)(19), Medical Practice Act;

(2) a court order authorizing the minor to consent to the abortion, in accordance with §33.003 or §33.004, Texas Family Code;

(3) an affidavit of the physician authorizing the physician to perform the abortion as if the court had issued an order granting the application or appeal, in accordance with §33.005, Texas Family Code; or

(4) indications supporting the physician's judgment, if the physician concludes, on the basis of good faith clinical judgment, that a condition exists that complicates the medical condition of the pregnant minor and necessitates the immediate abortion of her pregnancy to avert her death or to avoid a serious risk of substantial impairment of a major bodily function and that there is insufficient time to obtain the consent of the patient's parent, managing conservator, or legal guardian, in accordance with §164.052(a)(19), Medical Practice Act. The physician shall also maintain in the medical records a copy of the certification to the Department of State Health Services, as required by §33.002, Texas Family Code.

(c) Except in the case of a medical emergency, the physician shall obtain and maintain in the medical records a written consent signed by the patient that includes the requirements set forth in §171.011 and §171.012, Texas Health and Safety Code.

(d) The physician must use due diligence in determining that any person signing a written consent for an abortion on an unemancipated minor is, in fact, who the person purports to be. In any disciplinary action before the board, based on allegations that a consent was not signed by the person purporting to sign it, the physician must show that the written consent is either

(1) witnessed in the office or clinic of the physician; or

(2) is notarized.

(e) The physician shall maintain the medical records required by this section until the later of the fifth anniversary of the date of the patient's majority or the seventh anniversary of the date the physician received or created the documentation for the record.

(f) Pursuant to §164.052(c), Medical Practice Act, the board adopts the following form for physicians to obtain the consent required for an abortion to be performed on an unemancipated minor:

Figure: 22 TAC §165.6(f) (.pdf)

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on April 17, 2006.

TRD-200602199

Donald W. Patrick, MD, JD

Executive Director

Texas Medical Board

Earliest possible date of adoption: May 28, 2006

For further information, please call: (512) 305-7016


Chapter 166. PHYSICIAN REGISTRATION

22 TAC §§166.1, 166.2, 166.6

The Texas Medical Board proposes an amendment to §§166.1, 166.2 and 166.6, concerning Physician Registration.

The amendment to §166.1 eliminates reference to "written" application in order to allow for on-line registration and removes obsolete provisions that were adopted to transition from annual to biennial registration of physicians. The amendment to §166.2 adds a provision allowing emergency room physician to receive Continuing Medical Education in forensic evidence, as required by the Legislature in 2005. The amendment to §166.6 expands the rule regarding voluntary charity care by retired physicians to include care to medically underserved areas and for a disaster relief organization, as required by the Legislature in 2005.

Michele Shackelford, General Counsel, Texas Medical Board, has determined that for the first five-year period the amendments are in effect there will be no fiscal implications to state or local government as a result of enforcing the sections as proposed. There will be no effect to individuals required to comply with the sections as proposed.

Ms. Shackelford also has determined that for each year of the first five years the sections as proposed are in effect the public benefit anticipated as a result of enforcing the sections will be making the Board more efficient by allowing for on-line registration of physicians, to encourage continuing medical education in forensic evidence to assist in prosecution of sexual assault cases and allows the experience and expertise of retired physicians to be applied to a broader range of voluntary charity care. There will be no effect on small or micro businesses.

Comments on the proposal may be submitted to Sally Durocher, P.O. Box 2018, Austin, Texas 78768-2018. A public hearing will be held at a later date.

The amendments are proposed under the authority of the Texas Occupations Code Annotated, §153.001, which provides the Texas Medical Board to adopt rules and bylaws as necessary to: govern its own proceedings; perform its duties; regulate the practice of medicine in this state; enforce this subtitle; and establish rules related to licensure.

No other statutes, articles or codes are affected by this proposal.

§166.1.Physician Registration.

(a) Each physician licensed to practice medicine in Texas shall register with the board, submit a current physician profile, and pay a fee. A physician may obtain a registration permit ("permit") by submitting the required form and by paying the required registration fee to the board on or before the expiration date of the permit. The fee shall accompany an [ a written ] application prescribed by the board which sets forth the licensee's name, mailing address, primary practice site, and address for receipt of electronic mail if available.

(b) - (d) (No change.)

(e) [ Approximately half of all permits issued to license holders that expire between January 1, 2005 and December 31, 2005 shall remain in effect for a one-year period; the other half shall remain in effect for a two-year period. ] All permits issued to license holders that expire on or after January 1, 2006 shall remain in effect for two-year periods.

§166.2.Continuing Medical Education.

(a) As a prerequisite to the registration of a physician's permit a physician must complete 24 hours of continuing medical education (CME) every 12 months. CME hours must be completed in the following categories:

(1) - (3) (No change.)

(4) A physician whose practice includes treating patients in an emergency room setting may complete two hours of formal continuing medical education, as required by paragraph (1) of this subsection, relating to forensic evidence. To obtain credit for such courses, a course must include information regarding indicators of sexual assault and interviewing a person who may have been the victim of a sexual assault.

(b) - (p) (No change.)

§166.6.Exemption From Registration Fee for Retired Physician Providing Voluntary Charity Care.

(a) A retired physician licensed by the board whose only practice is the provision of voluntary charity care [ to indigent populations ] shall be exempt from the registration fee.

(b) As used in this section:

(1) "voluntary charity care" means medical care provided for no compensation to indigent populations, in medically underserved areas, or for a disaster relief organization.

(2) "compensation" means direct or indirect payment of anything of monetary value, except payment or reimbursement of reasonable, necessary, and actual travel and related expenses.

(c) To qualify for and obtain such an exemption, a physician must truthfully certify under oath, on a form approved by the board, and received by the board at least 30 days prior to the expiration date of the permit, that the following information is correct:

(1) the physician's practice of medicine does not include the provision of medical services for either direct or indirect compensation which has monetary value of any kind;

(2) the physician's practice of medicine is limited to voluntary charity care for which the physician receives no direct or indirect compensation of any kind for medical services rendered;

(3) the physician's practice of medicine does not include the provision of medical services to members of the physician's family; and

(4) the physician's practice of medicine does not include the self-prescribing of controlled substances or dangerous drugs.

(d) [ (b) ] A physician who qualifies for and obtains an exemption from the registration fee authorized under this section shall obtain and report continuing medical education as required under the Act, §§156.051-.055 and §166.2 of this title (relating to Continuing Medical Education) , except that the number of hours of informal CME, as required by §166.2(a)(3) shall be reduced from 12 hours to 10 hours .

(e) [ (c) ] A retired physician who has obtained an exemption from the registration fee as provided for under this section, may be subject to disciplinary action under the Act, §§164.051-.053, based on unprofessional or dishonorable conduct likely to deceive, defraud, or injure the public if the physician engages in the compensated practice of medicine, the provision of medical services to members of the physician's family, or the self-prescribing of controlled substances or dangerous drugs.

(f) [ (d) ] A physician who attempts to obtain an exemption from the registration fee under this section by submitting false or misleading statements to the board shall be subject to disciplinary action pursuant to the Act, §164.052(a)(1), in addition to any civil or criminal actions provided for by state or federal law.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on April 17, 2006.

TRD-200602200

Donald W. Patrick, MD, JD

Executive Director

Texas Medical Board

Earliest possible date of adoption: May 28, 2006

For further information, please call: (512) 305-7016


Chapter 170. AUTHORITY OF PHYSICIAN TO PRESCRIBE FOR THE TREATMENT OF PAIN

The Texas Medical Board proposes the repeal and replacement of §§170.1 - 170.3. The current Chapter is titled "Authority of Physician to Prescribe for the Treatment of Pain". The new title will be "Pain Management".

The repeal and replacement revises rules regarding guidelines for physicians in the treatment of pain.

Michele Shackelford, General Counsel, Texas Medical Board, has determined that for the first five-year period the repeal and replacement are in effect there will be no fiscal implications to state or local government as a result of enforcing the sections as proposed. There will be no effect to individuals required to comply with the sections as proposed.

Ms. Shackelford also has determined that for each year of the first five years the sections as proposed are in effect the public benefit anticipated as a result of enforcing the sections will be to provide better guidelines for physicians regarding the treatment of pain to address issues of adequate pain management as well as concern for the possible addiction to and diversion of pain medications. There will be no effect on small or micro businesses.

Comments on the proposal may be submitted to Sally Durocher, P.O. Box 2018, Austin, Texas 78768-2018. A public hearing will be held at a later date.

22 TAC §§170.1 - 170.3

(Editor's note: The text of the following sections proposed for repeal will not be published. The sections may be examined in the offices of the Texas Medical Board or in the Texas Register office, Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)

The repeals are proposed under the authority of the Texas Occupations Code Annotated, §153.001, which provides the Texas Medical Board to adopt rules and bylaws as necessary to: govern its own proceedings; perform its duties; regulate the practice of medicine in this state; enforce this subtitle; and establish rules related to licensure.

No other statutes, articles or codes are affected by this proposal.

§170.1.Purpose.

§170.2.Definitions.

§170.3.Guidelines.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on April 17, 2006.

TRD-200602201

Donald W. Patrick, MD, JD

Executive Director

Texas Medical Board

Earliest possible date of adoption: May 28, 2006

For further information, please call: (512) 305-7016


Chapter 170. PAIN MANAGEMENT

22 TAC §§170.1 - 170.3

The new sections are proposed under the authority of the Texas Occupations Code Annotated, §153.001, which provides the Texas Medical Board to adopt rules and bylaws as necessary to: govern its own proceedings; perform its duties; regulate the practice of medicine in this state; enforce this subtitle; and establish rules related to licensure.

No other statutes, articles or codes are affected by this proposal.

§170.1.Purpose.

The treatment of pain is a vital part of the practice of medicine. Optimal pain management, however, is difficult. The physician must temper the desire to relieve pain with concern for the addictive potential and possible abuse and diversion of drugs. This Rule sets forth the board's policy for the proper treatment of pain. The board's intent is to protect the public and give guidance to physicians. The principles underlying this policy include:

(1) Pain is a medical condition that every physician sees regularly. It is an integral part of the practice of medicine.

(2) The goal of pain management is to treat the patient's pain in relation to overall health. Physical function, psychological, social, and work-related factors affect the patient's need for pain treatment.

(3) Drugs may be essential for the treatment of pain.

(4) A license to practice medicine gives a physician legal authority to prescribe drugs for pain. The physician has a duty to use that authority to help, and not to harm patients and the public.

(5) Improper pain treatment may involve over-treatment, under-treatment, or no treatment. It may also involve prescribing drugs for purposes other than the treatment of a medical condition.

(6) Over-treatment of pain is a threat to patients and the public, because it may lead to abuse, addiction, and diversion of drugs. Thus, physicians must minimize this potential.

(7) Physicians should not fear board action if they provide proper pain treatment. Sound clinical judgment is the most important consideration.

(8) Sound clinical judgment results from evidence-based medicine or the use of generally accepted standards. The board will not look solely at the quantity or duration of drug therapy.

(9) Adequate medical records are crucial when a physician uses dangerous or scheduled drugs. The physician must keep current, legible, complete, and accurate records for each patient. The physician must record the rationale for the treatment plan in a way that shows that these guidelines have been followed.

(10) The extent of medical records must be reasonable for the case. For example, a treatment plan for acute, episodic pain may note only the dosage and frequency of drugs prescribed and that no further treatment is planned. Treatment of chronic pain, on the other hand, would require a more extensive plan, to assure that the success of the treatment is monitored. An explanation of the thought process is important when the physician continues scheduled drug therapy or escalates the prescription of scheduled drugs. A thorough explanation is especially required for cases in which treatment with scheduled drugs is difficult to relate to the patients objective physical, radiographic, or laboratory findings.

(11) The board does not require a physician to comply strictly with these guidelines, provided medical records show a sound basis for the treatment plan. A physician cannot always relieve all of a patient's pain. Proper pain treatment may require the escalation of drug use. The board will consider all factors, including:

(A) how a diagnosis supports the drug therapy;

(B) the efforts to monitor the efficacy of drug therapy; and

(C) whether the medical records show a rationale and plan to improve function.

§170.2.Definitions.

In this Chapter:

(1) "Abuse" or "substance abuse"--a patient's use of a drug for purposes other than the treatment of a medical condition, including pain, as prescribed by a physician.

(2) "Acute pain"--the normal, predicted, physiological response to a stimulus such as trauma and disease. Acute pain is time limited.

(3) "Addiction"--a primary, chronic, neurobiological disease characterized by craving and compulsive use of drugs. Addiction is often characterized by impaired control over drug use, including taking more drugs more often than prescribed by a physician. It may also be characterized by continued use despite harm to oneself or others. Genetic, psychosocial, and environmental factors may influence the development and manifestations of addiction. Physical dependence and tolerance are normal physiological consequences of extended drug therapy for pain and, alone, do not indicate addiction.

(4) "Chronic pain"-- a state in which pain persists beyond the usual course of an acute disease or healing of an injury. Chronic pain may be associated with a chronic pathologic process that causes continuous or intermittent pain over months or years.

(5) "Proper treatment of pain"--treatment of pain by a physician using sound clinical judgment documented by adequate medical records.

(6) "Scheduled drugs" (sometimes referred to as "Controlled Substances")--medications defined by the Texas Controlled Substances Act, Chapter 481, Texas Health and Safety Code. This Act establishes five categories, or schedules of drugs, based on risk of abuse and addiction. (Schedule I includes drugs that carry an extremely high risk of abuse and addiction and have no legitimate medical use. Schedule V includes drugs that have the lowest abuse/addiction risk).

(7) "Dangerous drugs"--medications defined by the Texas Dangerous Drug Act, Chapter 483, Texas Health and Safety Code. Dangerous drugs require a prescription, but are not included in the list of scheduled drugs. A dangerous drug bears the legend "Caution: federal law prohibits dispensing without a prescription" or "Prescription Only."

(8) "Diversion"--the use of drugs by anyone other than the person for whom the drug was prescribed by a physician.

(9) "Escalation"--increasing the dosage or frequency of the use of drugs.

(10) "Improper pain treatment"--includes over treatment, under treatment, no treatment, and the prescription of drugs for purposes other than the proper treatment of pain. Improper pain treatment results from the failure to follow the guidelines set forth in this Chapter.

(11) "Non-therapeutic"--has the same definition as improper pain treatment.

(12) "Pain"--An unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of tissue damage.

(13) "Physical dependence"--A state of adaptation that is a normal physiological consequence of extended drug therapy for pain. Symptoms of dependence can be produced by abruptly discontinuing drug therapy, rapidly reducing dosage, decreasing blood level of the drug, and administering an antagonist. Physical dependence, alone, does not indicate addiction.

(14) "Tolerance" (tachyphylaxis)--the progressive decrease in the relief of pain following extended drug therapy. Tolerance does not necessarily occur during drug treatment and does not, alone, indicate addiction.

(15) "Withdrawal"--the physiological and mental readjustment that accompanies discontinuation of a drug for which a person has established a physical dependence.

§170.3.Guidelines.

(a) The Texas Medical Board will use these guidelines to assess a physician's treatment of pain. Failure to follow these guidelines will be grounds for disciplinary action under the Medical Practice Act. The board interprets the word "Nontherapeutic," as used in §164.053(a)(5), Texas Occupations Code, to include improper pain treatment. "Must," as used in these guidelines means that failure to follow the guideline violates the Medical Practice Act, unless a sound basis for deviation is noted in the medical records. "Should" means that the guideline must be followed unless there is a sound basis for deviation.

(1) Evaluation of the patient.

(A) A physician must obtain a medical history either orally or in writing from the patient.

(B) The physician must perform a proper physical examination.

(C) The medical record should document the medical history and physical examination, including:

(i) the nature and intensity of the pain,

(ii) current and past treatments for pain,

(iii) underlying or coexisting diseases and conditions,

(iv) the effect of the pain on physical and psychological function,

(v) any history and potential for substance abuse, and

(vi) the presence of one or more recognized medical indications for the use of a dangerous or scheduled drug.

(2) Treatment plan. A written treatment plan must be included in the medical records. In preparing the treatment plan, the physician shall consider and the treatment plan should mention:

(A) dosage and frequency of any drugs prescribed,

(B) further testing and diagnostic evaluations to be ordered,

(C) other treatments that are planned or considered,

(D) periodic reviews planned, and

(E) objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function.

(3) Informed consent. The physician should discuss the risks and benefits of the use of dangerous and scheduled drugs with the patient. If the patient does not have medical decision-making capacity, the discussion should be with another appropriate person. Discussion of risks and benefits should include an explanation of the:

(A) diagnosis;

(B) treatment plan;

(C) anticipated therapeutic results, including the realistic expectations for sustained pain relief and improved functioning and it should be mentioned that it might not be possible to relieve all of the patient's pain;

(D) alternatives or complementary therapies to drug therapy, including physical therapy or psychological techniques;

(E) potential side effects and how to manage them, including the potential for dependence, addiction, escalation, tolerance, and withdrawal; and

(F) potential for impairment of judgment and motor skills.

(4) Agreement for treatment. The patient should agree to obtain prescriptions from only one physician and only one pharmacy. If the treatment plan includes extended drug therapy, the physician should consider the use of a written pain management agreement between the physician and the patient outlining patient responsibilities, including the following provisions:

(A) the physician may require laboratory tests for drug levels upon request;

(B) the physician may limit the number and frequency of prescription refills;

(C) only one physician will prescribe dangerous and scheduled drugs;

(D) only one pharmacy will be used for prescriptions, and

(E) reasons for which drug therapy may be discontinued (e.g. violation of agreement).

(5) Periodic review.

(A) The physician should see the patient for periodic review at reasonable intervals in view of the individual circumstances of the patient.

(B) Periodic review should assess progress toward reaching treatment objectives, taking into consideration the course of medications, as well as any new information about the etiology of the pain.

(C) Each periodic visit should be documented in the medical records.

(D) Contemporaneous to the periodic reviews, the physician should note in the medical records any adjustment in the treatment plan based on the individual medical needs of the patient.

(E) A physician should continue or modify the use of dangerous and scheduled drugs for pain management based on an evaluation of progress toward treatment objectives.

(i) Progress or the lack of progress in relieving pain must be documented in the patient's record.

(ii) Satisfactory response to treatment may be indicated by the patient's decreased pain, increased level of function, or improved quality of life.

(iii) Objective evidence of improved or diminished function should be monitored. Information from family members or other caregivers should be considered in determining the patient's response to treatment. If the patient's progress is unsatisfactory, the physician should assess the appropriateness of continued use of the current treatment plan and consider the use of other therapeutic modalities.

(6) Consultation and Referral. The physician should refer a patient for further evaluation and treatment as necessary. Patients who are at-risk for abuse, addiction, or diversion require special attention. Patients with a history of substance abuse or with a co-morbid psychiatric disorder require even more care. A consult with or referral to a pain management specialist should be considered in the treatment of such patients.

(7) Medical records. The medical records must document the physician's rationale for the treatment plan and the prescription of drugs and show that the physician has followed these guidelines. Specifically the records should include:

(A) the medical history and the physical examination;

(B) diagnostic, therapeutic and laboratory results;

(C) evaluations and consultations;

(D) treatment objectives;

(E) discussion of risks and benefits;

(F) informed consent;

(G) treatments;

(H) medications (including date, type, dosage and quantity prescribed);

(I) instructions and agreements; and

(J) periodic reviews.

(b) It is not the board's policy to take disciplinary action against a physician solely for not adhering strictly to these guidelines if the reason for deviation is documented in the medical records. Each case of prescribing for pain will be evaluated on an individual basis. The physician's conduct will be evaluated by considering:

(1) the treatment outcome, including any improvement in functioning;

(2) whether the drugs and amounts used are medically and pharmacologically recognized to be appropriate for the diagnosis;

(3) the patient's individual needs; and

(4) that some types of pain cannot be completely relieved.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on April 17, 2006.

TRD-200602202

Donald W. Patrick, MD, JD

Executive Director

Texas Medical Board

Earliest possible date of adoption: May 28, 2006

For further information, please call: (512) 305-7016


Chapter 171. POSTGRADUATE TRAINING PERMITS

22 TAC §§171.2 - 171.4, 171.6, 171.7

The Texas Medical Board proposes amendments to §§171.2-171.4, 171.6 and 171.7, concerning Postgraduate Training Permits.

The amendment to §171.2 reinforces the Board's authority to discipline a licensee who supervises a training program. The amendment to §171.3 requires that training programs for which physician in training permits are issued be supervised by a physician over which the Board has jurisdiction; makes more specific the requirements for certification of training program by supervisors; deletes obsolete provisions; and reorganizes the chapter to put annual reporting with other similar provisions. The amendment to §171.4 substantially revises the rule regarding postgraduate fellowship training programs that seek Board approval and assures that the program has been reviewed and approved by the graduate medical education committee of the institution. The amendment to §171.6 specifies a disciplinary action against the supervisor of a training program as an administrative violation and moves provisions for annual reporting from another section to include in the duties of a supervisor. The amendment to §171.7 changes the provision regarding a return to active status of a physician in training permit from mandatory to permissive upon a training program lifting a suspension.

Michele Shackelford, General Counsel, Texas Medical Board, has determined that for the first five-year period the amendments are in effect there will be no fiscal implications to state or local government as a result of enforcing the sections as proposed. There will be no effect to individuals required to comply with the sections as proposed.

Ms. Shackelford also has determined that for each year of the first five years the sections as proposed are in effect the public benefit anticipated as a result of enforcing the sections will be to assure that the Board can discipline a physician regarding the physician's duties in supervising a medical training program, assures that the Board has jurisdiction to oversee postgraduate training and reorganizes the chapter, assures that physician in training permits are issued on for fellowship programs that are based on needed training and quality education, assures that postgraduate training programs are properly supervised and gives the Board discretion to refuse to re-activate a physician in training permit after a training program has suspended a student and then lifted the suspension. There will be no effect on small or micro businesses.

Comments on the proposal may be submitted to Sally Durocher, P.O. Box 2018, Austin, Texas 78768-2018. A public hearing will be held at a later date.

The amendments are proposed under the authority of the Texas Occupations Code Annotated, §153.001, which provides the Texas Medical Board to adopt rules and bylaws as necessary to: govern its own proceedings; perform its duties; regulate the practice of medicine in this state; enforce this subtitle; and establish rules related to licensure.

The following statutes, articles or codes are affected by this proposal: §155.105, Texas Occupations Code.

§171.2.Construction.

(a) Unless otherwise indicated, permit holders under this chapter shall be subject to the duties, limitations, disciplinary actions, rehabilitation order provisions, and procedures applicable to licensees in the Medical Practice Act and board rules. Permit holders under this chapter shall also be subject to the limitations and restrictions elaborated in this chapter.

(b) Permit holders under this chapter shall cooperate with the board and board staff involved in investigation, review, or monitoring associated with the permit holder's practice of medicine. Such cooperation shall include, but not be limited to, permit holder's written response to the board or board staff written inquiry within 14 days of receipt of such inquiry.

(c) A physician-in-training permit holder's failure to comply with required annual reporting is grounds for disciplinary action by the Board.

(d) [ (c) ] In accordance with §155.105 of the Medical Practice Act, the board shall retain jurisdiction to discipline a permit holder whose permit has been terminated, canceled, and/or expired if the permit holder violated the Medical Practice Act or board rules during the time the permit was valid.

(e) [ (d) ] The issuance of a permit to a physician shall not be construed to obligate the board to issue the physician subsequent permits or licenses. The board reserves the right to investigate, deny a permit or full licensure, and/or discipline a physician regardless of when the information was received by the board.

§171.3.Physician-in-Training Permits.

(a) Definitions.

(1) Approved Postgraduate Training Program: a clearly defined and delineated postgraduate medical education training program, including postgraduate subspecialty training programs, approved by the Accreditation Council for Graduate Medical Education (ACGME), the American Osteopathic Association (AOA), the Committee on Accreditation of Preregistration Physician Training Programs, the Federation of Provincial Medical Licensing Authorities of Canada (internships prior to 1994), the Royal College of Physicians and Surgeons of Canada, or the College of Family Physicians of Canada.

(2) Board-approved [ Postgraduate ] Fellowship [ Training Program ]: a clearly defined and delineated postgraduate subspecialty-training program approved by the Texas [ State Board of ] Medical Board [ Examiners ] under §171.4 of this title .

(3) Designated Institutional Official (DIO): The individual in a sponsoring graduate medical education institution who has the authority and responsibility for the graduate medical education programs.

(4) Fellowship: A subspecialty training program of graduate medical education for postgraduate residents who have completed the requirements for eligibility for first board certification in the specialty and that is approved by the Accreditation Council for Graduate Medical Education (ACGME), the American Osteopathic Association (AOA), a member board of the American Board of Medical Specialties (ABMS), or a member board of the Bureau of Osteopathic Specialists (BOS).

(5) [ (3) ] Postgraduate Resident: a physician who is in postgraduate training as an intern, resident, or fellow in an approved postgraduate training program or a board-approved [ postgraduate ] fellowship [ training program ].

(6) [ (4) ] Physician-in-Training Permit:

(A) A physician-in-training permit is a permit issued by the board in its discretion to a physician who does not hold a license to practice medicine in Texas and is enrolled in a training program as defined in paragraphs (1) and (2) of this subsection in Texas, regardless of his/her postgraduate year (PGY) status within the program.

(B) The permit shall be effective for the length of the postgraduate training program as reported by the training program.

(C) A physician-in-training permit is valid only for the practice of medicine within the training program for which it was approved. If a permit holder enters into a new program that is not covered by the issued permit, the permit shall be terminated and the permit holder must apply for a new permit for the new program.

(D) A physician-in-training permit holder is restricted to the supervised practice of medicine that is part of and approved by the training program. The permit does not allow for the practice of medicine that is outside of the approved program.

(b) Qualifications of Physician-in-Training Permit Holders.

(1) To be eligible for a physician-in-training permit, an applicant must present satisfactory proof to the board that the applicant:

(A) is at least 18 years of age;

(B) is of good professional character and has not violated §§164.051-164.053 of the Medical Practice Act;

(C) is a graduate of a medical school or has completed a Fifth Pathway Program;

(D) has been accepted into an approved postgraduate training program or board-approved postgraduate fellowship training program; and

(E) has been credentialed by the postgraduate training program to include verification by the program of:

(i) the applicant's identity; and

(ii) the applicant's character and academic qualifications including verification of medical school graduation.

(2) To be eligible for a physician-in-training permit, an applicant must not have:

(A) a medical license, permit, or other authority to practice medicine that is currently restricted for cause, canceled for cause, suspended for cause, revoked or subject to another form of discipline in a state or territory of the United States, a province of Canada, or a uniformed service of the United States;

(B) an investigation or proceeding pending against the applicant for the restriction, cancellation, suspension, revocation, or other discipline of the applicant's medical license, permit, or authority to practice medicine in a state or territory of the United States, a province of Canada, or a uniformed service of the United States;

(C) a prosecution pending against the applicant in any state, federal, or Canadian court for any offense that under the laws of this state is a felony, a misdemeanor that involves the practice of medicine, or a misdemeanor that involves a crime of moral turpitude.

(c) Application for Physician-in-Training Permit.

(1) Application Procedures.

(A) Applications for a physician-in-training permit shall be submitted to the board no earlier than the ninetieth (90th) day prior to the date the applicant intends to begin postgraduate training in Texas to ensure the application information is not outdated. To assist in the expedited processing of the application, the application should be submitted as early as possible within the sixty-day window prior to the date the applicant intends to begin postgraduate training in Texas.

(B) The board may, in unusual circumstances, allow substitute documents where exhaustive efforts on the applicant's part to secure the required documents is presented. These exceptions shall be reviewed by the board's executive director on a case-by-case basis.

(C) For each document presented to the board, which is in a foreign language, an official word-for-word translation must be furnished. The board's definition of an official translation is one prepared by a government official, official translation agency, or a college or university official, on official letterhead. The translator must certify that it is a "true translation to the best of his/her knowledge, that he/she is fluent in the language, and is qualified to translate." He/she must sign the translation with his/her signature notarized by a Notary Public. The translator's name and title must be typed/printed under the signature.

(D) The board's executive director shall review each application for training permit and shall approve the issuance of physician-in-training permits for all applicants eligible to receive a permit. The executive director shall also report to the board the names of all applicants determined to be ineligible to receive a permit, together with the reasons for each recommendation. The executive director may refer any application to a committee or panel of the board for review of the application for a determination of eligibility.

(E) An applicant deemed ineligible to receive a permit by the executive director may request review of such recommendation by a committee or panel of the board within 20 days of written receipt of such notice from the executive director.

(F) If the committee or panel finds the applicant ineligible to receive a permit, such recommendation together with the reasons for the recommendation, shall be submitted to the board unless the applicant makes a written request for a hearing within 20 days of receipt of notice of the committee's or panel's determination. The hearing shall be before an administrative law judge of the State Office of Administrative Hearings and shall comply with the Administrative Procedure Act, the rules of the State Office of Administrative Hearings and the board. The board shall, after receiving the administrative law judge's proposed findings of fact and conclusions of law, determine the eligibility of the applicant to receive a permit. A physician whose application to receive a permit is denied by the board shall receive a written statement containing the reasons for the board's action.

(G) All reports and investigative information received or gathered by the board on each applicant are confidential and are not subject to disclosure under the Public Information Act, Gov't Code Chapter 552 and the Medical Practice Act, Tex. Occ. Code §§155.007(g), 155.058, and 164.007(c). The board may disclose such reports and investigative information to appropriate licensing authorities in other states.

(2) Physician-in-Training Permit Application. An application for a physician-in-training permit must be on forms furnished by the board and include the following:

(A) the required fee as mandated in the Medical Practice Act, §153.051 and as construed in board rules[ , payable by personal check, money order or cashier's check through a United States bank ];

(B) certification by the postgraduate training program:

(i) for a Texas postgraduate training program, a certification must be completed by the director of medical education, the chair of graduate medical education, the program director, or, if none of the previously named positions is held by a Texas licensed physician, the Texas Licensed physician supervising [ physician, of ] the postgraduate training program on a form provided by the board that certifies that:

(I) [ (i) ] the program meets the definition of an approved postgraduate training program in subsection (a)(2) and (3) of this section;

(II) [ (ii) ] the applicant has met all educational and character requirements established by the program and has been accepted into the program; and

(III) [ (iii) ] the program has received a letter from the dean of the applicant's medical school that [ which ] states that the applicant is scheduled to graduate from medical school before the date the applicant plans to begin postgraduate training, if the applicant has not yet graduated from medical school . [ ; and ]

(ii) [ (iv) ] if the applicant is completing rotations in Texas as part of the applicant's residency out-of-state training program or with the military : [ , the facility at which the rotations are being completed, and the dates the rotations will be completed in Texas; ]

(I) a certification must be completed by the director of medical education, the chair of graduate medical education, the program director, or, if none of the previously named positions is held by a physician licensed in any state, the supervising physician, licensed in any state, of the postgraduate training program on a form provided by the board that certifies that:

(-a-) the program meets the definition of an approved postgraduate training program in subsection (a)(2) and (3) of this section;

(-b-) the applicant has met all educational and character requirements established by the program and has been accepted into the program;

(-c-) the program has received a letter from the dean of the applicant's medical school which states that the applicant is scheduled to graduate from medical school before the date the applicant plans to begin postgraduate training, if the applicant has not yet graduated from medical school; and

(II) a certification by the Texas Licensed physician supervising the Texas rotations of the postgraduate training program on a form provided by the board that certifies: [ , ]

(-a-) the facility at which the rotations are being completed,

(-b-) the dates the rotations will be completed in Texas, and

(-c-) that the Texas postgraduate training program will supervise and be responsible for the applicant during the rotation in Texas;

(C) arrest records. If an applicant has ever been arrested, a copy of the arrest and arrest disposition must be requested from the arresting authority by the applicant and said authority must submit copies directly to the board;

(D) medical records for inpatient treatment for alcohol/substance abuse, mental illness, and physical illness. Each applicant who has been admitted to an inpatient facility within the last five years for the treatment of alcohol/substance abuse, mental illness (recurrent or severe major depressive disorder, bipolar disorder, schizophrenia, schizoaffective disorder, or any severe personality disorder), or physical illness shall submit documentation to include, but not limited to:

(i) an applicant's statement explaining the circumstances of the hospitalization;

(ii) all records, submitted directly from the inpatient facility;

(iii) a statement from the applicant's treating physician/psychotherapist as to diagnosis, prognosis, medications prescribed, and follow-up treatment recommended; and

(iv) a copy of any contracts signed with any licensing authority or medical society or impaired physician's committee;

(E) medical records for outpatient treatment for alcohol/substance abuse, mental illness, or physical illness. Each applicant that has been treated on an outpatient basis within the last five years for alcohol/substance abuse, mental illness (recurrent or severe major depressive disorder, bipolar disorder, schizophrenia, schizoaffective disorder, or any severe personality disorder), or physical illness shall submit documentation to include, but not limited to:

(i) an applicant's statement explaining the circumstances of the outpatient treatment;

(ii) a statement from the applicant's treating physician/psychotherapist as to diagnosis, prognosis, medications prescribed, and follow-up treatment recommended; and

(iii) a copy of any contracts signed with any licensing authority or medical society or impaired physician's committee;

(F) an oath on a form provided by the board attesting to the truthfulness of statements provided by the applicant;

(G) such other information or documentation the board and/or the executive director deem necessary to ensure compliance with this chapter, the Medical Practice Act and board rules.

(d) Expiration of Physician-in-Training Permit.

(1) Physician-in-Training permits shall be issued with effective dates corresponding with the beginning and ending dates of the postgraduate resident's training program as reported to the board by the program director.

(2) Physician-in-training permits shall expire on any of the following, whichever occurs first:

(A) on the reported ending date of the postgraduate training program;

(B) on the date a postgraduate training program terminates or otherwise releases a permit holder from its training program; or

(C) on the date the permit holder obtains full licensure or temporary licensure pending full licensure pursuant to §155.002 of the Act.

(3) Physician-in-training permit holders who are issued permits on or after April 1, 2005, and who require extensions to remain in a training program after a program's reported ending date must submit a written request to the board and fee, if required, along with a statement by the program director authorizing the request for the extension. Such extensions shall be granted at the discretion of the board's executive director and may not be for longer than 90 days unless good cause is shown.

[ (4) If a postgraduate resident was issued a permit for a program with an initial start date prior to April 1, 2005, and the permit is set to expire before the ending date of the permit holder's training program, and the expiration date is on or after July 2, 2005, the program director and/or permit holder must submit an application and fee requesting that the permit be extended to the ending date of the training program. The fee shall be in accordance with §175.1(2)(B) of this title (relating to Fees, Penalties, and Applications).]

[ (e) Annual reports. Program directors for postgraduate training programs must ensure that the board receives certain information annually in order to keep the board informed on a permit holder's progress while in the approved training program. The required information shall be sent to the board on forms provided by the board and shall include:]

[ (1) information regarding the permit holder's criminal and disciplinary history, professional character, mailing address, and place where engaged in training since the program director's last report;]

[ (2) certification by the permit holder's program director, on a form provided by the board, regarding the permit holder's training; and]

[ (3) such other information or documentation the board and/or the executive director deem necessary to ensure compliance with this chapter, the Medical Practice Act and board rules.]

(e) [ (f) ] The executive director of the board may, in his/her discretion, issue a temporary physician-in-in-training permit to an applicant if the applicant and the postgraduate training program have submitted written requests. The executive director, in his/her discretion, will determine the length of the permit and may issue additional temporary physician-in-training permits to an applicant.

§171.4.Board-Approved Fellowships [ Postgraduate Fellowship Training Programs ].

(a) The executive director may in his/her discretion, upon written request, approve fellowships [ training programs ] as referenced in §171.3(a) (2) [ (3) ] of this chapter [ for up to three years ]. Fellowships meeting the criteria set forth in §171.3(a)(4) of this chapter do not require board approval for physician-in-training permits to be issued to subspecialty postgraduate residents in the fellowship. [ The initial request should be submitted to the executive director 180 days prior to the beginning date of the program to assist in the expedited processing of an application. Said training programs shall be limited to postgraduate subspecialty programs. ] If the executive director does not recommend approval, the institution's designated institutional official (DIO) and chair of the Graduate Medical Education Committee (GMEC) [ program's director ] may appeal to the board for its discretionary consideration of the request.

(b) The initial request for approval should be submitted to the executive director, on a form prescribed by the board, 90 days prior to the beginning date of the program to assist in the expedited processing of an application. The request must include the length of the fellowship; the length of time for which the institution is requesting approval of the fellowship itself, not to exceed five years; and other information as required by the board. [ Approval of training programs shall include but not be limited to the following considerations: ]

(c) Approval of fellowships requires certification by the DIO and the chair of the GMEC of the institution in which the fellowship will be conducted that the fellowship program has been evaluated and approved by the institution's graduate medical education committee. The evaluation shall include but not be limited to satisfactory demonstration to the committee of the fellowship's:

(1) [ the ] goals and objectives [ of the program ]; documented curriculum; and, qualifications of the program director and program faculty, including, but not limited to, certification by the appropriate specialty board and/or appropriate educational qualifications;

(2) [ the ] process by which [ the program selects ] subspecialty postgraduate residents are selected ;

(3) prerequisite requirements of the postgraduate residents, including whether prior residency training in a related specialty is required [ of subspecialty postgraduate residents in the program ];

(4) delineated [ the ] duties and responsibilities required of subspecialty postgraduate residents in the program [ including the number of subspecialty postgraduate residents to be enrolled each year and when subspecialty postgraduate residents are required to be permanently licensed ];

(5) number of subspecialty postgraduate residents to be enrolled each year [ the formal educational experiences required of subspecialty postgraduate residents in the program, including grand rounds, seminars and journal club ];

(6) [ the ] scholarly activity to be [ research ] required of subspecialty postgraduate residents [ in the program, including participation in peer reviewed and funded research which may result in publications or presentations at regional and national scientific meetings ];

(7) [ the ] type of supervision to be provided for subspecialty postgraduate residents [ by the program ];

[ (8) the curriculum vitae, including academic appointments, of all supervising staff;]

(8) [ (9) ] requirements for [ that ] the program director or supervising physician to hold [ holds ] a Texas license or faculty temporary license issued by the board;

[ (10) the academic affiliation of the program;]

(9) [ (11) ] [ the ] methods for evaluation of subspecialty postgraduate residents by the program; and

[ (12) whether a specialty board that is a member of the American Board of Medical Specialties or the Bureau of Osteopathic Specialists gives credit for the program; and]

(10) [ (13) ] [ the ] progressive nature , including, but not limited to, the progressively greater responsibility of the subspecialty postgraduate residents throughout the course of the fellowship if the fellowship [ training program ] is over one year in length.

(d) Institutions with board-approved fellowships must determine whether to conduct internal reviews of the program at the mid-point of the program's most recent approval period.

(e) Institutions with board-approved fellowships that are eligible for accreditation as described in §171.3(a)(4) of this chapter must determine whether the fellowship should seek such accreditation rather than board approval of the fellowship.

(f) [ (c) ] The DIO and the chair of the GMEC of the institution for which a [ All program directors for ] fellowship program has [ training programs that have ] been previously approved by the board must apply to have the program [ be re-evaluated ] approved again, if the program is to continue after the expiration date [ to assure compliance with the above considerations and consideration of continuation of the fellowship training program ]. Applications for subsequent approval must comply with all requirements in this section for initial approval and must be submitted [ The program director must apply for re-evaluation ] at least three [ six ] months prior to the expiration of the approved program in order to prevent a lapse in time of the fellowship [ training program ]. Permit holders shall be allowed to complete their fellowship [ training program ] regardless of continuing program approval [ re-evaluation ].

(g) [ (d) ] All board-approved fellowships that subsequently become approved by the ACGME , AOA, a member board of the ABMS, or a member board of the BOS, [ or AOA ] must notify the board within 30 days of their approval. Fellowships may not be dually approved by the board and ACGME , AOA, a member board of the ABMS, or a member board of the BOS [ or AOA ]. A board-approved fellowship that becomes approved by the ACGME , AOA, a member board of the ABMS, or a member board of the BOS [ or AOA approved ] immediately loses its board-approved status when its new approval becomes effective through the ACGME , AOA, a member board of the ABMS, or a member board of the BOS [ or AOA ].

(h) All fellowships that have been approved before September 1, 2006 shall terminate no later than August 31, 2007, but shall expire on such earlier date provided in the approval. A new application for approval must be submitted at least three months prior to the expiration date or on June 1, 2007, whichever date is earlier. All requests for board approval of fellowships submitted on or after September 1, 2006 must comply with the requirements of this chapter.

§171.6.Duties of Program Directors to Report [ Certain Types of Conduct ].

(a) Failure of any postgraduate training program director to comply with the provisions of this chapter or the Medical Practice Act §160.002 and §160.003 may be grounds for disciplinary action as an administrative violation against the program director.

(b) The director of each approved postgraduate training program shall report in writing to the executive director of the board the following circumstances within seven days of the director's knowledge for any physician-in-training permit holder completing postgraduate training:

(1) if a physician did not begin the training program due to failure to graduate from medical school as scheduled or for any other reason(s);

(2) if a physician has been or will be absent from the program for more than 21 consecutive days (excluding vacation, family, or military leave) and the reason(s) why;

(3) if a physician has been arrested after the permit holder begins training in the program;

(4) if a physician poses a continuing threat to the public welfare as defined under Tex. Occ. Code §151.002(a)(2), as amended;

(5) if the program has taken final action that adversely affects the physician's status or privileges in a program for a period longer than 30 days;

(6) if the program has suspended the physician from the program;

(7) if the program has requested termination or terminated the physician from the program, requested or accepted withdrawal of the physician from the program, or requested or accepted resignation of the permit holder from the program and the action is final.

(c) Annual reports. Program directors for postgraduate training programs must ensure that the board receives certain information annually in order to keep the board informed on a permit holder's progress while in the approved training program. The required information shall be sent to the board on forms provided by the board and shall include:

(1) information regarding the permit holder's criminal and disciplinary history, professional character, mailing address, and place where engaged in training since the program director's last report;

(2) certification by the permit holder's program director, on a form provided by the board, regarding the permit holder's training; and

(3) such other information or documentation the board and/or the executive director deem necessary to ensure compliance with this chapter, the Medical Practice Act and board rules.

(d) [ (c) ] A violation of §§164.051-164.053 or any other provision of the Medical Practice Act is grounds for disciplinary action by the Board.

§171.7.Inactive Status.

(a) A physician-in-training permit holder who is placed on suspension, dismissed, or terminated by a training program shall have his permit placed on inactive status.

(b) The board retains jurisdiction to investigate any physician-in-training permit holder placed on inactive status for possible violation(s) of the Medical Practice Act and/or board rules.

(c) If a postgraduate training program lifts the suspension of a physician-in-training permit holder, the program must notify the board of the lifted suspension and board may [ shall ] return the physician's permit to active status effective the date the board is notified that the suspension is lifted.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on April 17, 2006.

TRD-200602203

Donald W. Patrick, MD, JD

Executive Director

Texas Medical Board

Earliest possible date of adoption: May 28, 2006

For further information, please call: (512) 305-7016


Chapter 172. TEMPORARY AND LIMITED LICENSES

Subchapter C. LIMITED LICENSES

22 TAC §172.13

The Texas Medical Board proposes new §172.13, concerning Conceded Eminence.

New §172.13 creates a new limited license for physicians with conceded eminence in their specialty, as required by SB 419.

Michele Shackelford, General Counsel, Texas Medical Board, has determined that for the first five-year period the new section is in effect there will be no fiscal implications to state or local government as a result of enforcing the section as proposed. There will be no effect to individuals required to comply with the section as proposed.

Ms. Shackelford also has determined that for each year of the first five years the section as proposed is in effect the public benefit anticipated as a result of enforcing the section will be to increase the effectiveness of recruiting professors for Texas medical schools. There will be no effect on small or micro businesses.

Comments on the proposal may be submitted to Sally Durocher, P.O. Box 2018, Austin, Texas 78768-2018. A public hearing will be held at a later date.

The new section is proposed under the authority of the Texas Occupations Code Annotated, §153.001, which provides the Texas Medical Board to adopt rules and bylaws as necessary to: govern its own proceedings; perform its duties; regulate the practice of medicine in this state; enforce this subtitle; and establish rules related to licensure.

The following statutes, articles or codes are affected by this proposal: §155.006, Texas Occupations Code.

§172.13.Conceded Eminence.

(a) The board may issue a license to an applicant pursuant to the authority of §155.006, Tex. Occ. Code, by virtue of the applicant's conceded eminence and authority in the applicant's specialty.

(b) "Conceded eminence and authority in the applicant's specialty," as used in this section, shall mean that the physician has achieved a high level of academic or professional recognition for excellence in research, teaching, or the practice of medicine, as evidenced by objective factors, including academic appointments, length of time in a profession, scholarly publications and presentations, professional accomplishments, and awards.

(c) An applicant for a license based on conceded eminence must complete an application showing that the applicant:

(1) is recommended to the board by the dean, president, or chief academic officer of:

(A) a school of medicine in this state;

(B) The University of Texas Health Center at Tyler;

(C) The University of Texas M.D. Anderson Cancer Center, or

(D) a program of graduate medical education, accredited by the Accreditation Council for Graduate Medical Education, that exceeds the requirements for eligibility for first board certification in the discipline;

(2) is expected to receive an appointment at the institution or program making the recommendation under paragraph (1) of this subsection;

(3) has not failed a licensing examination within the three-attempt limit provided by §163.6(b) and §163.6(f)(1) of this title;

(4) has passed the Texas Medical Jurisprudence Examination;

(5) has successfully completed at least one year of approved subspecialty training accredited by the Accreditation Council for Graduate Medical Education or the American Osteopathic Association;

(6) is of good professional character, as defined by §163.1(a)(9) of this title;

(7) has conceded eminence and authority in a medical specialty identified in the application;

(8) has not been the subject of disciplinary action by any other state, the uniformed services of the United States, or the applicant's peers in a local, regional, state, or national professional medical association or staff of a hospital;

(9) has not been convicted of, or placed on deferred adjudication, community supervision, or deferred disposition for a felony, a misdemeanor connected with the practice of medicine, or a misdemeanor involving moral turpitude. And

(10) has read and will abide by board rules and the Medical Practice Act.

(d) Applicants with complete applications may qualify for a Temporary License prior to being considered by the board for licensure, as required by §172.11 of this title (relating to Temporary Licensure--Regular).

(e) The holder of a conceded eminence license shall be limited to the practice of only a specialty of medicine for which the license holder has conceded eminence and authority, as identified in the application. The license holder may only practice medicine within the setting of the institution or program that recommended the license holder under subsection (c)(1) of this section, including a setting that is part of the institution or program by contractual arrangement.

(f) If the holder of a conceded eminence license terminates the relationship with the institution or program that recommended the license holder under subsection (c)(1) of this section, the conceded eminence license shall be considered automatically canceled. To practice medicine in Texas, the license holder must:

(1) file a new application with the recommendation of a new institution or program, as required by subsection (c)(1) of this section, or

(2) file an application for another Texas medical license or permit.

(g) The holder of a conceded eminence license shall be required to pay the same fees and meet all other procedural requirements for issuance and renewal of the license as a person holding a full Texas medical license.

(h) The holder of a conceded eminence license shall be subject to disciplinary action under the Medical Practice Act and board rules.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on April 17, 2006.

TRD-200602204

Donald W. Patrick, MD, JD

Executive Director

Texas Medical Board

Earliest possible date of adoption: May 28, 2006

For further information, please call: (512) 305-7016


Chapter 174. TELEMEDICINE

22 TAC §174.2, §174.6

The Texas Medical Board proposes an amendment to §174.2 and new §174.6, concerning Telemedicine.

The amendment to §174.2 adds the definition for "telepresenter." New §174.6 creates standards for delegation by a physician to a non-physician in the practice of telemedicine.

Michele Shackelford, General Counsel, Texas Medical Board, has determined that for the first five-year period the sections are in effect there will be no fiscal implications to state or local government as a result of enforcing the sections as proposed. There will be no effect to individuals required to comply with the sections as proposed.

Ms. Shackelford also has determined that for each year of the first five years the sections as proposed are in effect the public benefit anticipated as a result of enforcing the sections will be to define the use of non-physicians in the practice of telemedicine and to assures that physicians delegate duties only to properly trained and qualified personnel in the practice of telemedicine. There will be no effect on small or micro businesses.

Comments on the proposal may be submitted to Sally Durocher, P.O. Box 2018, Austin, Texas 78768-2018. A public hearing will be held at a later date.

The amendment and new section are proposed under the authority of the Texas Occupations Code Annotated, §153.001, which provides the Texas Medical Board to adopt rules and bylaws as necessary to: govern its own proceedings; perform its duties; regulate the practice of medicine in this state; enforce this subtitle; and establish rules related to licensure.

No other statutes, articles or codes are affected by this proposal.

§174.2.Definitions.

The following words and terms, when used in this chapter shall have the following meanings unless the context indicates otherwise.

(1) Medical practice site--A patient-specific Internet site, access to which is limited to licensed physicians, associated medical personnel and patients. It is an interactive site and thus qualifies as a practice location. It requires a defined physician-patient relationship.

(2) Medium--Any mechanism of information transfer including electronic means.

(3) Person--An individual unless otherwise expressly made applicable to a partnership, association, or corporation.

(4) Physician-patient e-mail--A computer-based communication between physician (or their medical personnel) and patients within a professional relationship in which the physician has taken on an explicit measure of responsibility for the patient's care.

(5) Telemedicine medical service--A health care service initiated by a physician or provided by a health professional acting under physician delegation and supervision, for purposes of assessment by a health professional, diagnosis or consultation by a physician, treatment, or the transfer of medical data, that requires the use of advanced telecommunications other than by telephone or facsimile as described in §57.042 of the Utilities Code.

(6) Telepresenter--a remote site provider, as defined in 1 TAC §354.1430, who is not a physician, registered nurse, advanced practice nurse or physician assistant, unless such physician, registered nurse, advanced practice nurse or physician assistant is a qualified mental health professional as defined in §531.02175(a) of the Government Code.

§174.6.Delegation to and Supervision of Telepresenters.

(a) A physician may delegate tasks and activities to a telepresenter who is qualified by licensing, training or experience for the performance of the task or activity as long as the task or activity does not require the exercise of independent medical judgment for its performance;

(b) A physician delegating tasks or activities to a telepresenter shall ensure that the telepresenter to whom delegation is made is qualified by licensure, training, or experience to perform the task or activity delegated;

(c) A physician delegating tasks or activities to a telepresenter shall ensure that the telepresenter to whom delegation is made is adequately supervised.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on April 17, 2006.

TRD-200602205

Donald W. Patrick, MD, JD

Executive Director

Texas Medical Board

Earliest possible date of adoption: May 28, 2006

For further information, please call: (512) 305-7016


Chapter 175. FEES, PENALTIES AND FORMS

22 TAC §175.5

The Texas Medical Board proposes new §175.5, concerning Payment of Fees or Penalties.

New §175.5 specifies the procedure for payment of fees and penalties, including payment on-line.

Michele Shackelford, General Counsel, Texas Medical Board, has determined that for the first five-year period the section is in effect there will be no fiscal implications to state or local government as a result of enforcing the section as proposed. There will be no effect to individuals required to comply with the section as proposed.

Ms. Shackelford also has determined that for each year of the first five years the section as proposed is in effect the public benefit anticipated as a result of enforcing the section will be to provide guidance in the procedures for payment of fees and penalties to the Board. There will be no effect on small or micro businesses.

Comments on the proposal may be submitted to Sally Durocher, P.O. Box 2018, Austin, Texas 78768-2018. A public hearing will be held at a later date.

The new section is proposed under the authority of the Texas Occupations Code Annotated, §153.001, which provides the Texas Medical Board to adopt rules and bylaws as necessary to: govern its own proceedings; perform its duties; regulate the practice of medicine in this state; enforce this subtitle; and establish rules related to licensure.

No other statutes, articles or codes are affected by this proposal.

§175.5.Payment of Fees or Penalties.

Fees paid online must be submitted by credit card, electronic check, or debit card, as required by the online application. All other licensure fees or penalties must be submitted in the form of a money order, personal check, or cashier's check payable on or through a United States bank. Fees and penalties cannot be refunded. If a single payment is made for more than one individual permit, it must be made for the same class of permit and a detailed listing, on a form prescribed by the board, must be included with each payment.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on April 17, 2006.

TRD-200602206

Donald W. Patrick, MD, JD

Executive Director

Texas Medical Board

Earliest possible date of adoption: May 28, 2006

For further information, please call: (512) 305-7016


Chapter 178. COMPLAINTS

22 TAC §178.8

The Texas Medical Board proposes an amendment to §178.8, concerning Appeals.

The amendment to §178.8 deletes the time limit for a complainant to appeal the dismissal of a complaint.

Michele Shackelford, General Counsel, Texas Medical Board, has determined that for the first five-year period the section is in effect there will be no fiscal implications to state or local government as a result of enforcing the section as proposed. There will be no effect to individuals required to comply with the section as proposed.

Ms. Shackelford also has determined that for each year of the first five years the section as proposed is in effect the public benefit anticipated as a result of enforcing the section will be removing time limits for a member of the public who has complained against a physician to appeal a Board decision to dismiss the complaint. There will be no effect on small or micro businesses.

Comments on the proposal may be submitted to Sally Durocher, P.O. Box 2018, Austin, Texas 78768-2018. A public hearing will be held at a later date.

The amendment is proposed under the authority of the Texas Occupations Code Annotated, §153.001, which provides the Texas Medical Board to adopt rules and bylaws as necessary to: govern its own proceedings; perform its duties; regulate the practice of medicine in this state; enforce this subtitle; and establish rules related to licensure.

No other statutes, articles or codes are affected by this proposal.

§178.8.Appeals.

(a) Initiation. Following the receipt of the notice of dismissal of a complaint, the complainant may appeal the dismissal to the board. To be considered by the board, the appeal must:

(1) be in writing; and

[ (2) be received within 60 days of the mailing of the notice of dismissal of the complaint; and]

(2) [ (3) ] list the reason(s) for the appeal. The appeal should provide sufficient information to indicate that additional review is warranted.

(b) - (e) (No change.)

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on April 17, 2006.

TRD-200602207

Donald W. Patrick, MD, JD

Executive Director

Texas Medical Board

Earliest possible date of adoption: May 28, 2006

For further information, please call: (512) 305-7016


Chapter 185. PHYSICIAN ASSISTANTS

22 TAC §§185.1 - 185.4, 185.6 - 185.8, 185.13, 185.15 - 185.19, 185.22, 185.23, 185.26

The Texas Medical Board proposes amendments to §§185.1 - 185.4, 185.6 - 185.8, 185.13, 185.15 - 185.19, 185.22, 185.23 and new §185.26, concerning Physician Assistants.

The amendment to §185.1 expands the expressed purpose of the Physician Assistant Board to more fully state the functions of the Board. The amendment to §185.2 conforms the name of the Physician Assistant Board and the Medical Board as required by SB 419 and adds definitions for clarity. The amendment to §185.3 conforms the rule to SB 419 changes regarding the appointment of the presiding officer of the Physician Assistant Board; changes the name of the Long Range Planning Committee to the Executive Committee; and revises duties of the committees. The amendment to §185.4 updates the name of the Accreditation Review Commission for the Education of Physician Assistants and adds the Jurisprudence Exam as a required exam for Physician Assistant licensure. The amendment to §185.6 sets out procedure and fees for reinstatement of Physician Assistant license after expiration. The amendment to §185.7 updates the name of the Accreditation Review Commission for the Education of Physician Assistants and allows a temporary license to be issued to a Physician Assistant who cannot demonstrate the required active practice. The amendment to §185.8 places additional limits of Physician Assistants to place their license on inactive status. The amendment to §185.13 adds requirements for a Physician Assistant to notify the Board of the termination of a supervising physician. The amendment to §185.15 eliminates unnecessary words. The amendment to §185.16 updates the name of the Medical Board to conform to changes made by SB 419. The amendment to §185.17 eliminates unnecessary words and adds to grounds for discipline the writing of a false prescription for a controlled substance. The amendment to §185.18 corrects a reference to another section and adds criminal convictions to the list of subjects in the Medical Boards rules that are adopted by reference. The amendment to §185.19 abbreviates Administrative Procedure Act, as defined. The amendment to §185.22 changes "this" to "the" in reference to the Physician Assistant Act. The amendment to §185.23 conforms the name of the Physician Assistant Board with changes made by SB 419. New §185.26 authorizes the Physician Assistant Board to accept the voluntary surrender of a license and adopts Medical Board procedures for voluntary surrender.

Michele Shackelford, General Counsel, Texas Medical Board, has determined that for the first five-year period the sections are in effect there will be no fiscal implications to state or local government as a result of enforcing the sections as proposed. There will be no effect to individuals required to comply with the sections as proposed.

Ms. Shackelford also has determined that for each year of the first five years the sections as proposed are in effect the public benefit anticipated as a result of enforcing the sections will be to provide a better description of the functions of the Physician Assistant Board, update the rules and provide additional definitions, update the rule to conform to the statute and provides more effective committee structure for the Physician Assistant Board, assures that licensed Physician Assistants have knowledge of the legal requirement for practice as a Physician Assistant, makes clear the procedures and fees required for a Physician Assistant after expiration of a license, allows Physician Assistants to be temporarily licensed, pending the demonstration of clinical competency through the active practice as a Physician Assistant, assures that a Physician Assistant who returns to practice after being on inactive status is clinically competent to practice, assures that the Board is notified upon the termination of a supervising physician, economizes on the language used to describe the Physician Assistant Act, makes the rule clear regarding the name of the Medical Board, economizes on language and conforms the rule to the statutory provision making it a violation of the Physician Assistant Act to write a false prescription for a controlled substance, corrects references in the rule and conforms the rule to disciplinary guidelines used by the Medical Board, economizes on language used in the rule, corrects language of the rule, updates name of the Physician Assistant Board and provides a more efficient way to resolve some disciplinary cases. There will be no effect on small or micro businesses.

Comments on the proposal may be submitted to Sally Durocher, P.O. Box 2018, Austin, Texas 78768-2018. A public hearing will be held at a later date.

The amendments and new section are proposed under the authority of the Texas Occupations Code Annotated, §153.001, which provides the Texas Medical Board to adopt rules and bylaws as necessary to: govern its own proceedings; perform its duties; regulate the practice of medicine in this state; enforce this subtitle; and establish rules related to licensure.

No other statutes, articles or codes are affected by this proposal.

§185.1.Purpose.

(a) These rules are promulgated under the authority of the Medical Practice Act, Title 3, Subtitle B, Texas Occupations Code and the Physician Assistant Licensing Act, Chapter 204, Texas Occupations Code, to establish procedures and standards for the training, education, licensing, and discipline of persons performing as a physician assistant in this State so as to establish an orderly system of regulating the practice of a physician assistant in a manner that protects the health, safety, and welfare of the public. [ The purpose of these rules is to create a system of licensing and regulating physician assistants as a means to ensure the competency of physician assistants without a financial burden to the people of Texas. Furthermore, the purpose of these rules and regulations is to also encourage the more effective utilization of the skills of physicians by enabling them to delegate health care tasks to qualified physician assistants. These sections are not intended to, and shall not be construed to, restrict the physician from delegating technical and clinical tasks to technicians, other assistants, or employees who perform delegated tasks in the office of a physician and who are not rendering services as a physician assistant or identifying themselves as a physician assistant. Nothing in these rules and regulations shall be construed to relieve the supervising physician of the professional or legal responsibility for the care and treatment of his or her patients. ]

(b) The functions of the physician assistant board include but are not limited to the following:

(1) Establish standards for the practice of a physician assistant.

(2) Regulate the practice of a physician assistant through the licensure and discipline of physician assistants.

(3) Interpret the Physician Assistant Licensing Act and the physician assistant board Rules to ensure that physician assistants, other allied health professionals, and consumers are properly informed.

(4) Receive complaints and investigate possible violations of the Physician Assistant Licensing Act and the physician assistant board Rules.

(5) Discipline violators through appropriate legal action to enforce the Physician Assistant Licensing Act and the physician assistant board Rules.

(6) Provide a mechanism for public comment with regard to the Physician Assistant Licensing Act and the physician assistant board Rules.

(7) Review and modify the physician assistant board Rules when necessary and appropriate.

(8) Examine and license qualified applicants to practice as a physician assistant in Texas in a manner that ensures that applicable standards are maintained.

(9) Provide recommendations to the legislature concerning appropriate changes to the Physician Assistant Licensing Act to ensure that the acts are current and applicable to changing needs and practices.

(10) Provide public information on licensees.

(11) Maintain data concerning the practice of a physician assistant.

§185.2.Definitions.

The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise.

(1) (No change.)

(2) Agency--The divisions, departments, and employees of the Texas [ State Board of ] Medical Board [ Examiners ], the Texas [ State Board of ] Physician Assistant Board [ Examiners ], and the Texas State Board of Acupuncture Examiners.

(3) - (4) (No change.)

(5) Applicant--A party seeking a license from the Texas [ State Board of ] Physician Assistant Board [ Examiners ].

(6) Board or the "physician assistant board"--The Texas [ State Board of ] Physician Assistant Board [ Examiners ].

(7) Executive Director--the Executive Director of the Agency or the authorized designee of the Executive Director.

(8) Good professional character--an applicant for licensure must not be in violation of or committed any act described in the Physician Assistant Licensing Act, §§204.302-204.304, Texas Occupations Code Annotated.

(9) [ (7) ] Medical Board--The Texas [ State Board of ] Medical Board [ Examiners ].

(10) [ (8) ] Medical Practice Act--Texas Occupations Code Annotated, Title 3, Subtitle B, as amended.

(11) [ (9) ] Open Meetings Act--Texas Government Code Annotated, Chapter 551 as amended.

(12) [ (10) ] Party--The physician assistant board and each person named or admitted as a party in a [ SOAH ] hearing before the State Office of Administrative Hearings or contested case before the physician assistant board.

(13) [ (11) ] Physician assistant--A person licensed as a physician assistant by the Texas [ State Board of ] Physician Assistant Board [ Examiners ].

(14) Presiding Officer--The person appointed by the Governor to serve as the presiding officer of the board.

(15) [ (12) ] State--Any state, territory, or insular possession of the United States and the District of Columbia.

(16) [ (13) ] Submit--The term used to indicate that a completed item has been actually received and date-stamped by the board along with all required documentation and fees, if any.

(17) [ (14) ] Supervising physician--A physician licensed by the medical board [ either as a doctor of medicine or doctor of osteopathic medicine ] who assumes responsibility and legal liability for the services rendered by the physician assistant, and who has notified the Medical Board of the intent [ received approval from the medical board ] to supervise a specific physician assistant and of the termination of such supervision .

(18) [ (15) ] Supervision--Overseeing the activities of, and accepting responsibility for, the medical services rendered by a physician assistant. Supervision does not require the constant physical presence of the supervising physician but includes a situation where a supervising physician and the person being supervised are, or can easily be, in contact with one another by radio, telephone, or another telecommunication device.

§185.3.Meetings and Committees .

(a) - (d) (No change.)

(e) The governor shall designate a member of the physician assistant board as the presiding officer of the board to serve in that capacity at the will of the governor. The board, at a regular meeting or special meeting, shall [ may ] elect from its membership a [ presiding officer and a ] secretary for one year.

(f) The board, at a regular meeting or special meeting, upon majority vote of the members present, may remove the [ presiding officer or ] the secretary from office.

(g) The following are standing and permanent committees of the board. Each committee, with the exception of the Executive Committee, shall consist of at least one board member who is a licensed physician, one board member who is a licensed physician assistant, and one public board member. In the event that a committee does not have a representative of one or more of these groups, the presiding officer shall appoint additional members as necessary to maintain this composition. The Executive Committee shall include the presiding officer, secretary, and other members as named by the presiding officer. The presiding officer shall name the chair and assign the members of the other committees. The responsibilities and authority of these committees shall include those duties and powers as defined in paragraphs (1) - (3) of this subsection and such other responsibilities and authority which the board may from time to time delegate to these committees.

(1) Licensure Committee.

(A) - (E) (No change.)

(F) Oversee and make recommendations to the physician assistant board regarding any aspect of the examination process including the approval of an appropriate licensure examination and the administration of such an examination and documentation and verification of records from all applicants for licensure;

(2) Disciplinary [ and Ethics ] Committee.

(A) Draft and review proposed rules regarding the discipline of physician assistants and enforcement of the [ Physician Assistant Licensing ] Act.

(B) Oversee the disciplinary process and give guidance to the board and staff regarding methods to improve the disciplinary process and more effectively enforce the [ Physician Assistant Licensing ] Act.

(C) - (D) (No change.)

[ (E) Draft and review proposed ethics guidelines and rules for the practice of physician assistants, and make recommendations to the board regarding the adoption of such ethics guidelines and rules.]

(E) [ (F) ] Make recommendations to the board and staff regarding policies, priorities, budget, and any other matters related to the disciplinary process and enforcement of the [ Physician Assistant Licensing ] Act.

(F) [ (G) ] Make recommendations to the board regarding matters brought to the attention of the Disciplinary [ and Ethics ] Committee.

(3) Executive [ Long Range Planning ] Committee.

(A) Ensure records are maintained of all committee actions; [ Formulate and make recommendations to the board concerning future board goals and objectives and the establishment of priorities and methods for their accomplishment. ]

(B) Review requests from the public to appear before the board and provide opportunities for the public to speak regarding issues related to the regulations of practice of Physician Assistants; [ Study and make recommendations to the board regarding the role and responsibility of the board officers and committees. ]

(C) Review inquiries regarding policy or administrative procedure; [ Study and make recommendations to the board regarding ways to improve the efficiency and effectiveness of the administration of the board. ]

(D) Delegate tasks to other committees; [ Study and make recommendations to the board regarding board rules or any area of a board function that, in the judgment of the committee needs consideration. ]

(E) Take action on matter of urgency that may arise between board meetings; such matters shall be presented to the board at the next board meeting; [ Study and make recommendations to the board regarding legislative changes pertinent to the practice of Physician Assistants. ]

(F) Assist the Medical Board in the organization, preparation, and delivery of information and testimony to the Legislators and committees of the Legislature; [ Study and make recommendations to the board regarding financial issues. ]

(G) Formulate and make recommendations to the board regarding future board goals and objectives and the establishment of priorities and methods for their accomplishment;

(H) Study and make recommendations to the board regarding the role and responsibility of the board officers and committees;

(I) Review staff reports regarding finances and the budget; and

(J) Make recommendations to the board regarding matters brought to the attention of the Executive Committee.

(h) Meetings of the board and of its committees are open to the public unless such meetings are conducted in executive session pursuant to the Open Meetings Act, the [ Physician Assistant Licensing ] Act, or the Medical Practice Act. In order that board meetings may be conducted safely, efficiently, and with decorum, attendees [ members of the public shall refrain at all times from smoking or using tobacco products, eating, or reading newspapers and magazines. Members of the public ] may not engage in disruptive activity that interferes with board proceedings[ , including excessive movement within the meeting room, noise or loud talking, and resting of feet on tables and chairs ]. The public shall remain within those areas of the board offices and board meeting room designated as open to the public. Members of the public shall not address or question board members during meetings unless recognized by the board's presiding officer pursuant to a published agenda item.

(i) Journalists have the same right of access as other members of the public to board meetings conducted in open session, and are also subject to the same rules [ of conduct described in subsection (h) of this section ]. Observers of any board meeting may not disrupt the meeting or disturb participants. Observers may make audio or visual recordings of such proceedings conducted in open session as long as these activities do not disrupt the meeting and subject to the following limitations: the board's presiding officer may request periodically that camera operators extinguish their artificial lights to allow excessive heat to dissipate; camera operators may not assemble or disassemble their equipment while the board is in session and conducting business; persons seeking to position microphones for recording board proceedings may not disrupt the meeting or disturb participants . Journalists [ ; journalists ] may conduct interviews in the reception area of the agency's [ medical board's ] offices or, at the discretion of the board's presiding officer, in the meeting room after recess or adjournment; no interview may be conducted in the hallways of the agency's [ medical board's ] offices; and the board's presiding officer may exclude from a meeting any person who, after being duly warned, persists in conduct described in this subsection and subsection (h) of this section.

(j) (No change.)

(k) In the event of the absence or temporary incapacity of the presiding officer, and the secretary, the members of the board may elect another member to act as the presiding officer of a board meeting or may elect an interim acting presiding officer for the duration of the absences or incapacity or until another presiding officer is appointed by the governor .

(l) Upon the death, resignation, removal or permanent incapacity of the presiding officer or the secretary, the board shall elect a secretary from its membership an officer to fill the vacant position. The board may elect an interim acting presiding officer until another presiding officer is appointed by the governor. Such an election shall be conducted as soon as practicable at a regular or special meeting of the board.

§185.4.Procedural Rules for Licensure Applicants.

(a) Except as otherwise provided in this section, an individual shall be licensed by the board before the individual may function as a physician assistant. A license shall be granted to an applicant who:

(1) - (2) (No change.)

(3) has successfully completed an educational program for physician assistants or surgeon assistants accredited by the Accreditation Review Commission for the Education of Physician Assistants (ARC-PA) [ Commission on Accreditation of Allied Health Education Programs ], or by that committee's predecessor or successor entities, and holds a valid and current certificate issued by the National Commission on Certification of Physician Assistants ("NCCPA");

(4) - (6) (No change.)

(7) is of good professional character as defined under §185.1(7) of this title.

(8) [ (7) ] submits to the board any other information the board considers necessary to evaluate the applicant's qualifications; [ and ]

(9) [ (8) ] meets any other requirement established by rules adopted by the board ; and [ . ]

(10) for applicants who apply for a license on or after January 1, 2007, passes the national licensing examination required for NCCPA certification within no more than three attempts.

(11) for applicants who apply for a license on or after September 1, 2007, passes a jurisprudence examination ("JP exam"), which shall be conducted on the licensing requirements and other laws, rules, or regulations applicable to the physician assistant profession in this state. The jurisprudence examination shall be developed and administered as follows:

(A) The staff of the Medical Board shall prepare questions for the JP exam and provide a facility by which applicants can take the examination.

(B) Applicants must pass the JP exam with a score of 75 or better within three attempts.

(C) An examinee shall not be permitted to bring medical books, compends, notes, medical journals, calculators or other help into the examination room, nor be allowed to communicate by word or sign with another examinee while the examination is in progress without permission of the presiding examiner, nor be allowed to leave the examination room except when so permitted by the presiding examiner.

(D) Irregularities during an examination such as giving or obtaining unauthorized information or aid as evidenced by observation or subsequent statistical analysis of answer sheets, shall be sufficient cause to terminate an applicant's participation in an examination, invalidate the applicant's examination results, or take other appropriate action.

(E) An applicant who is unable to pass the JP exam within three attempts must appear before a committee of the board to address the applicant's inability to pass the examination and to re-evaluate the applicant's eligibility for licensure. It is at the discretion of the committee to allow an applicant additional attempts to take the JP exam.

(b) The following documentation shall be submitted as a part of the licensure process:

(1) - (2) (No change.)

(3) Examination Scores. Each applicant for licensure must have a certified transcript of grades submitted directly from the appropriate testing service to the board for all examinations accepted by the board for licensure.

(4) [ (3) ] Verification from other states. Each applicant for licensure who is licensed, registered, or certified in another state must have that state submit directly to the board, on a form provided by the board, that the physician assistant's license, registration, or certification is current and in full force and that the license, registration, or certification has not been restricted, canceled, suspended, or revoked. The other state shall also include a description of any sanctions imposed by or disciplinary matters pending in the state.

(5) [ (4) ] State License Registration. Each applicant, if licensed, registered, or certified in another state as a physician assistant, must submit a copy of the license registration certificate to the board. The license, registration, or certificate number and the date of expiration must be visible on the copy.

(6) [ (5) ] Arrest Records. If an applicant has ever been arrested, a copy of the arrest and arrest disposition needs to be requested from the arresting authority and that authority must submit copies directly to the board.

(7) [ (6) ] Malpractice. If an applicant has ever been named in a malpractice claim filed with any liability carrier or if an applicant has ever been named in a malpractice suit, the applicant must:

(A) have each liability carrier complete a form furnished by this board regarding each claim filed against the applicant's insurance;

(B) for each claim that becomes a malpractice suit, have the attorney representing the applicant in each suit submit a letter directly to the board explaining the allegation, dates of the allegation, and current status of the suit. If the suit has been closed, the attorney must state the disposition of the suit, and if any money was paid, the amount of the settlement. The letter shall be accompanied by supporting documentation including court records if applicable. If such letter is not available, the applicant will be required to furnish a notarized affidavit explaining why this letter cannot be provided; and

(C) provide a statement, composed by the applicant, explaining the circumstances pertaining to patient care in defense of the allegations.

(8) [ (7) ] Additional Documentation. Additional documentation as is deemed necessary to facilitate the investigation of any application for licensure must be submitted.

(c) - (d) (No change.)

(e) Applicants for licensure:

(1) whose application for licensure which has been filed with the board office and which is in excess of one year [ two years ] old from the date of receipt, shall be considered inactive. Any fee previously submitted with the application shall be forfeited. Any further application procedure for licensure will require submission of a new application and inclusion of the current licensure fee;

(2) - (6) (No change.)

(7) who previously held a Texas health care provider license , certificate, permit, or registration may be required to complete additional forms as required.

§185.6.Annual Renewal of License.

(a) - (b) (No change.)

(c) Falsification of an affidavit or submission of false information to obtain renewal of a license shall subject a physician assistant to denial of the renewal and/or to discipline pursuant to the [ Physician Assistant Licensing ] Act, §§204.301-.303.

(d) - (f) (No change.)

(g) Practicing as a physician assistant as defined in the [ Physician Assistant Licensing ] Act without an annual registration permit for the current year as provided for in the board rules has the same force and effect as and is subject to all penalties of practicing as a physician assistant without a license.

(h) (No change.)

(i) Expired Annual Registration Permits.

(1) If a physician assistant's registration permit has expired, the physician assistant may register for a new permit without monetary penalty during the first 30 days following expiration. If a physician assistant's permit has been expired for longer than 30 days, but less than 91, the physician may obtain a new permit by submitting to the board a completed permit application, the registration fee, and the penalty fee, as defined in §175.3(2) of this title.

(2) If a physician assistant's registration permit has been expired for longer than 90 days but less than one year, the physician assistant may obtain a new permit by submitting a completed permit application, the registration fee, and a penalty fee as defined in §175.3(2) of this title.

(3) If a physician assistant's registration permit has been expired for one year or longer, the physician assistant's license is automatically canceled, unless an investigation is pending, and the physician assistant may not obtain a new permit.

(4) Practicing as a physician assistant after the expiration of the 30-day grace period under subsection (a) of this section without obtaining a new registration permit for the current registration period has the same effect as, and is subject to all penalties of, practicing as a physician assistant without a license.

§185.7.Temporary License.

(a) The board, or its designee may issue a temporary license to an applicant who:

(1) meets all the qualifications for a license under the [ Physician Assistant Licensing ] Act but is waiting for the next scheduled meeting of the board for the license to be issued;

(2) seeks to temporarily substitute for a licensed physician assistant during the licensee's absence, if the applicant:

(A) - (B) (No change.)

(C) pays the appropriate fee prescribed by the board; [ or ]

(3) has graduated from an educational program for physician assistants or surgeon assistants accredited by the Accreditation Review Commission for the Education of Physician Assistants (ARC-PA) [ Commission on Accreditation of Allied Health Education Programs ] or by the committee's predecessor or successor entities no later than six months previous to the application for temporary licensure and is waiting for examination results from the National Commission on Certification of Physician Assistants ; or [ . ]

(4) has not, on a full-time basis, actively practiced as a physician assistant , as defined under §185.4(d) of this title, but meets guidelines set by the physician assistant board including, but not limited to, length of time out of active practice as a physician assistant and duration of temporary licenses.

(b) (No change.)

§185.8.Inactive License.

(a) - (b) (No change.)

(c) A license holder who practices as a physician assistant in Texas while on inactive status is considered to be practicing without a license.

(d) A physician assistant may return to active status by applying to the board, paying an application fee equal to an application fee for a physician assistant license, [ the license renewal fee, ] complying with the requirements for license renewal under the [ Physician Assistant Licensing ] Act , providing current verifications from each state in which the physician assistant holds a license, demonstrating current certification by NCCPA, and submitting professional evaluations from each employment held after the license was placed on inactive status, and complying with subsection (e) of this section.

(e) A physician assistant applicant applying to return to active status shall provide sufficient documentation to the board that the applicant has, on a full-time basis as defined in §185.4(d) of this title (relating to Procedural Rules for Licensure Applicants) [ chapter ], actively practiced as a physician assistant or has been on the active teaching faculty of an acceptable approved physician assistant program, within either of the two years preceding receipt of an application for reactivation. Applicants who do not meet this requirement may, in the discretion of the board, be eligible for the reactivation of a license subject to one or more of the following conditions or restrictions as set forth in paragraphs (1) - (5) of this subsection:

(1) - (3) (No change.)

(4) remedial education; and /or

(5) (No change.)

(f) After five years on inactive status, the license shall be canceled as if by request. The physician assistant may obtain a new license by complying with the requirements and procedures for obtaining an original license.

§185.13.Notification of Intent to Practice and Supervise.

(a) A physician assistant licensed under the [ Physician Assistant Licensing ] Act must, before beginning practice or upon changing practice, submit notification of the license holder's intent to begin practice. Notification under this section must include:

(1) - (2) (No change.)

(b) (No change.)

(c) For the purposes of this section, a single form prescribed by the board shall be used to provide notification of the license holder's intent to begin practice or termination of, and any changes in, or additions to, the person acting as a supervising physician.

(d) (No change.)

§185.15.Supervising Physician.

(a) (No change.)

(b) A physician assistant may be supervised by an alternate supervising physician in the absence of the supervising physician consistent with this chapter, the Texas Medical Practice Act, the [ Physician Assistant Licensing ] Act, board rules, medical board rules, and any standing orders or protocols established in accordance with these statutes and rules.

§185.16.Employment Guidelines.

(a) - (c) (No change.)

(d) A physician who provides medical services in preventive medicine, disease management, health and wellness education, or similar services in an accredited academic/teaching institution listed in paragraphs (1) - (10) of this subsection, or its affiliates, may be denoted as the supervising physician for more than five physician assistants in that institution or its affiliates, provided the supervising physician determines that the physician assistants are properly trained to deliver the services, that the services are of such a nature that they may be safely and competently delivered by the supervised physician assistants, and the proper paperwork has been filed with the [ Texas State Board of ] Medical Board [ Examiners ]. The supervision of physician assistants must comply with all institutional rules and there must be accurate and timely internal institutional records, which are available upon request within 24 hours to the [ Texas State Board of ] Medical Board [ Examiners ], which list the name and license number of the physician who is specifically assigned to actively supervise each physician assistant at one of the following institutions:

(1) - (10) (No change.)

(e) A physician who holds the position of Medical Director, Chief of Staff, or Emergency Room Department Chair at a licensed hospital may be denoted as the supervising physician for more than five physician assistants for the purpose of staffing a hospital emergency room. This physician may then delegate the direct supervision of the physician assistant to staff physicians providing medical services within the emergency room, provided that the supervising physician determines that the physician assistants are properly trained to deliver services, that the services are of such a nature that they may be safely and competently delivered by the supervised physician assistants, and that the proper paperwork has been filed with the [ Texas State Board of ] Medical Board [ Examiners ]. The supervision of physician assistants must comply with all institutional rules and there must be accurate and timely internal institutional records, which are available upon request within 24 hours to the Texas [ State Board of ] Medical Board [ Examiners ], which list the name and license number of the physician who is specifically assigned to actively supervise each physician assistant.

(f) (No change.)

§185.17.Grounds for Denial of Licensure and for Disciplinary Action.

The board may refuse to issue a license to any person and may, following notice of hearing and a hearing as provided for in the APA [ Administrative Procedure Act ], take disciplinary action against any physician assistant who:

(1) - (2) (No change.)

(3) violates the [ Physician Assistant Licensing ] Act, or any rules relating to the practice of a physician assistant;

(4) - (13) (No change.)

(14) writes a false or fictitious prescription for a scheduled or a dangerous drug as defined by Chapters 481 and [ Chapter ] 483, Health and Safety Code;

(15) - (22) (No change.)

§185.18.Discipline of Physician Assistants.

(a) The board, upon finding a physician assistant has committed any of the acts set forth in §185.17 [ §185.18 ] of this title (relating to Grounds for Denial of Licensure and for Disciplinary Action), shall enter an order imposing one or more of the allowable actions set forth under §204.301 of the Act.

(b) Disciplinary Guidelines.

(1) Chapter 190 of this title (relating to Disciplinary Guidelines) shall apply to physician assistants regulated under this chapter to be used as guidelines for the following areas as they relate to the denial of licensure or disciplinary action of a licensee:

(A) - (C) (No change.)

(D) repeated and recurring meritorious health care liability claims; [ and ]

(E) aggravating and mitigating factors ; and [ . ]

(F) criminal convictions.

(2) If the provisions of Chapter 190 of this title conflict with the Act or rules under this chapter, the Act and provisions of this chapter shall control.

§185.19.Administrative Penalties.

(a) The board by order may impose an administrative penalty, subject to the provisions of the APA [ Administrative Procedure Act ], against a person licensed or regulated under the [ Physician Assistant Licensing ] Act who violates the Act or a rule or order adopted under the Act.

(b) - (c) (No change.)

§185.22.Impaired Physician Assistants.

(a) (No change.)

(b) Rehabilitation Orders.

(1) - (2) (No change.)

(3) Violation of a rehabilitation order entered pursuant to this section may result in disciplinary action under the provisions of the [ this ] Act for contested matters or pursuant to the terms of the agreed order. A violation of a rehabilitation order may be grounds for disciplinary action based on unprofessional or dishonorable conduct or on any of the provisions of this Act which may apply to the misconduct which resulted in violation of the rehabilitation order.

(4) (No change.)

§185.23.Third Party Reports to the Board.

(a) - (c) (No change.)

(d) Reporting Professional Liability Claims.

(1) - (4) (No change.)

(5) Penalty. Failure by a licensed insurer to report under this section shall be referred to the Texas Department [ State Board ] of Insurance.

(6) - (8) (No change.)

(9) Reporting Form. The reporting form shall be as follows:

Figure: 22 TAC §185.23(d)(9)

(10) (No change.)

(e) (No change.)

§185.26.Voluntary Surrender of Physician Assistant License.

Pursuant to §204.315 of the Act, the Board may accept the voluntary surrender of a physician assistant license. Chapter 196 of this title (relating to Voluntary Surrender of a Medical License) shall govern the voluntary surrender of a physician assistant license in a similar manner as that chapter applies to a medical license. Section 185.4 of this title (relating to Procedural Rules for Licensure Applicants) shall govern reapplication after a voluntary surrender.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on April 17, 2006.

TRD-200602208

Donald W. Patrick, MD, JD

Executive Director

Texas Medical Board

Earliest possible date of adoption: May 28, 2006

For further information, please call: (512) 305-7016


Chapter 192. OFFICE-BASED ANESTHESIA SERVICES

22 TAC §§192.1 - 192.5

The Texas Medical Board proposes amendments to §§192.1 - 192.5, concerning Office Based Anesthesia Services.

The amendment to §192.1 adds definitions necessary to provide regulation for the administration of analgesics and anxiolytics, as required by SB 419. The amendment to §192.2 expands the rule to include regulation of the use of analgesics and anxiolytics, as required by SB 419. The amendment to §192.3 broadens the reference to anesthesia services to include use of analgesics and anxiolytics. The amendment to §192.4 expands the reference to anesthesia and conforms payment of fees for registration of office based anesthesia services so that fees are paid by each physician and not by the site location. The amendment to §192.5 broadens the reference to anesthesia services to include use of analgesics and anxiolytics.

Michele Shackelford, General Counsel, Texas Medical Board, has determined that for the first five-year period the amendments are in effect there will be no fiscal implications to state or local government as a result of enforcing the sections as proposed. There will be no effect to individuals required to comply with the sections as proposed.

Ms. Shackelford also has determined that for each year of the first five years the sections as proposed are in effect the public benefit anticipated as a result of enforcing the sections will be to provide assurance that properly trained personnel and equipment will be present for any medical procedure in which analgesics and anxiolytics are administered and to assure that each physician that provides office based anesthesia services registers with the Board. There will be no effect on small or micro businesses.

Comments on the proposal may be submitted to Sally Durocher, P.O. Box 2018, Austin, Texas 78768-2018. A public hearing will be held at a later date.

The amendments are proposed under the authority of the Texas Occupations Code Annotated, §153.001, which provides the Texas Medical Board to adopt rules and bylaws as necessary to: govern its own proceedings; perform its duties; regulate the practice of medicine in this state; enforce this subtitle; and establish rules related to licensure.

No other statutes, articles or codes are affected by this proposal.

§192.1.Definitions.

The following words and terms, when used in this chapter, shall have the following meanings, unless the contents indicate otherwise.

(1) ACLS--Advanced Cardiac Life Support, as defined by the AHA.

(2) AED--Automatic External Defibrillator.

(3) AHA--American Heart Association.

(4) Analgesics--Dangerous or scheduled drugs that alleviate pain.

(5) Anesthesia--The loss of feeling or sensation resulting from the use of dangerous or scheduled drugs to depress nerve function. Anesthetics are scheduled or dangerous drugs used to induce anesthesia.

(6) Anesthesia Services--The use of dangerous and scheduled drugs, including anesthetics, analgesics, and anxiolytics, to permit the performance of surgery or other painful medical procedures.

(7) Anxiolytics--Dangerous or scheduled drugs used to treat episodes of anxiety.

(8) [ (1) ] Anesthesiologist [ Anesthesiologist's ] assistant--A graduate of an approved anesthesiologist [ anesthesiologist's ] assistant training program.

(9) [ (2) ] Anesthesiology resident--A physician who is presently in an approved Texas anesthesiology residency program who is either licensed as a physician in Texas or holds a postgraduate resident permit issued by the Texas [ State Board of ] Medical Board [ Examiners ].

(10) BCLS--Basic Cardiac Life Support, as defined by the AHA.

(11) [ (3) ] Certified registered nurse anesthetist--A person licensed by the Board of Nurse Examiners for the State of Texas (BNE) as a registered professional nurse, authorized by the BNE as an advanced practice nurse in the role of nurse anesthetist, and certified by a national certifying body recognized by the BNE.

(12) Dangerous drugs--medications defined by the Texas Dangerous Drug Act, Chapter 483, Texas Health and Safety Code. Dangerous drugs require a prescription, but are not included in the list of scheduled drugs. A dangerous drug bears the legend "Caution: federal law prohibits dispensing without a prescription" or "Prescription Only."

(13) Level I services--delivery of analgesics or anxiolytics by mouth, as prescribed for the patient on order of a physician, at a dose level low enough to allow the patient to remain ambulatory.

(14) Level II services--delivery of analgesics or anxiolytics by mouth in dosages greater than allowed at Level I and tunescent anesthesia, as prescribed for the patient on order of a physician.

(15) Level III services--delivery of analgesics or anxiolytics other than by mouth, including intravenously, intramuscularly, or rectally.

(16) Level IV services--delivery of general anesthetics, including regional anesthetics and monitored anesthesia care.

(17) [ (4) ] Monitored anesthesia care--Situations where a patient undergoing a diagnostic or therapeutic procedure receives doses of medication that create a risk of loss of normal protective reflexes or loss of consciousness and the patient remains able to protect the airway during [ for the majority of ] the procedure. If[ , for an extended period of time, ] the patient is rendered unconscious and [ and/or ] loses normal protective reflexes, then anesthesia care shall be considered a general anesthetic.

(18) [ (5) ] Outpatient setting--Any facility, clinic, center, office, or other setting that is not a part of a licensed hospital or a licensed ambulatory surgical center with the exception of all of the following listed in subparagraphs (A) - (D) of this paragraph:

(A) a clinic located on land recognized as tribal land by the federal government and maintained or operated by a federally recognized Indian tribe or tribal organization as listed by the United States secretary of the interior under 25 U.S.C. (479-1 or as listed under a successor federal statute or regulation;

(B) a facility maintained or operated by a state or governmental entity;

(C) a clinic directly maintained or operated by the United States or by any of its departments, officers, or agencies; and

(D) an outpatient setting accredited by either the Joint Commission on Accreditation of Healthcare Organizations relating to ambulatory surgical centers, the American Association for the Accreditation of Ambulatory Surgery Facilities, or the Accreditation Association for Ambulatory Health Care.

(19) [ (6) ] Board--The Texas [ State Board of ] Medical Board [ Examiners ].

(20) PALS--Pediatric Advanced Life Support, as defined by the AHA.

(21) [ (7) ] Physician--A person licensed by the Texas [ State Board of ] Medical Board [ Examiners ] as a medical doctor or doctor of osteopathic medicine who diagnoses, treats, or offers to treat any disease or disorder, mental or physical, or any physical deformity or injury by any system or method or effects cures thereof and charges therefor, directly or indirectly, money or other compensation. "Physician" and "surgeon" shall be construed as synonymous.

(22) Scheduled Drugs--medications defined by the Texas Controlled Substances Act, Chapter 481, Texas Health and Safety Code. This Act establishes five categories, or schedules of drugs, based on risk of abuse and addiction. (Schedule I includes drugs that carry an extremely high risk of abuse and addiction and have no legitimate medical use. Schedule V includes drugs that have the lowest abuse/addiction risk).

§192.2.Provision of Anesthesia Services in Outpatient Settings.

(a) The purpose of these rules is to identify the roles and responsibilities of physicians providing, or overseeing by proper delegation, anesthesia services in outpatient settings and to provide the minimum acceptable standards for the provision of anesthesia services in outpatient settings.

(b) The rules promulgated under this title do not apply to physicians who practice in the following settings listed in paragraphs (1) - (8) of this subsection:

(1) an outpatient setting in which only local anesthesia, peripheral nerve blocks, or both are used;

(2) any setting physically located outside the State of Texas [ an outpatient setting in which only anxiolytics and analgesics are used and only in doses that do not have the significant probability of placing the patient at risk for loss of the patient's life-preserving protective reflexes ];

(3) a licensed hospital, including an outpatient facility of the hospital that is separately located apart from the hospital;

(4) a licensed ambulatory surgical center;

(5) a clinic located on land recognized as tribal land by the federal government and maintained or operated by a federally recognized Indian tribe or tribal organization as listed by the United States secretary of the interior under 25 U.S.C. (479-1 or as listed under a successor federal statute or regulation;

(6) a facility maintained or operated by a state or governmental entity;

(7) a clinic directly maintained or operated by the United States or by any of its departments, officers, or agencies; and

(8) an outpatient setting accredited by:

(A) the Joint Commission on Accreditation of Healthcare Organizations relating to ambulatory surgical centers;

(B) the American Association for the Accreditation of Ambulatory Surgery Facilities; or

(C) the Accreditation Association for Ambulatory Health Care.

(c) Standards for Anesthesia Services. The following standards are required for outpatient settings providing anesthesia services that are administered within two hours before an out patient procedure. If personnel and equipment meet the requirements of a higher level, lower level anesthesia services may also be provided.

(1) Level I services:

(A) at least two personnel must be present, including the physician who must be currently certified at least in AHA approved BCLS; and

(B) the following age-appropriate equipment must be present:

(i) bag mask valve;

(ii) oxygen;

(iii) AED or other defibrillator; and

(iv) pre-measured doses of epinephrine, atropine, adreno-corticoids, and antihistamines.

(2) Level II services:

(A) at least two personnel must be present, including the physician who must be currently certified at least in AHA approved ACLS or PALS, as appropriate;

(i) another person must be currently certified at least in AHA approved BCLS; and

(ii) a licensed health care provider, who may be one of the two required personnel, must attend the patient, until the patient is ready for discharge; and

(B) a crash cart must be present containing drugs and equipment necessary to carry out ACLS protocols, including, but not limited to, the following age-appropriate equipment:

(i) bag mask valve and appropriate airway maintenance devices;

(ii) oxygen;

(iii) AED or other defibrillator;

(iv) pre-measured doses of first line cardiac medications, including epinephrine, atropine, adreno-corticoids, and antihistamines;

(v) IV equipment;

(vi) pulse oximeter; and

(vii) EKG Monitor.

(3) Level III services:

(A) at least two personnel must be present, including the physician who must be currently certified at least in AHA approved ACLS or PALS, as appropriate;

(i) another person must be currently certified at least in AHA approved BCLS;

(ii) a licensed health care provider, which may be either of the two required personnel, must attend the patient, until the patient is ready for discharge; and

(iii) a person, who may be either of the two required personnel, must be responsible for monitoring the patient during the procedure; and

(B) the same equipment required for Level II;

(4) [ (c) ] Physicians who practice medicine in this state and who administer anesthesia or perform a [ surgical ] procedure for which anesthesia services are provided in [ an ] outpatient settings at Level IV shall follow current, applicable standards and guidelines as put forth by the American Society of Anesthesiologists (ASA) including, but not limited to, the following listed in paragraphs (1) - (8) of this subsection:

(A) [ (1) ] Basic Standards for Preanesthesia Care;

(B) [ (2) ] Standards for Basic Anesthetic Monitoring;

(C) [ (3) ] Standards for Postanesthesia Care;

(D) [ (4) ] Position on Monitored Anesthesia Care;

(E) [ (5) ] The ASA Physical Status Classification System;

(F) [ (6) ] Guidelines for Nonoperating Room Anesthetizing Locations;

(G) [ (7) ] Guidelines for Ambulatory Anesthesia and Surgery; and

(H) [ (8) ] Guidelines for Office-Based Anesthesia.

(d) A physician delegating the provision of anesthesia or anesthesia-related services to a certified registered nurse anesthetist shall be in compliance with ASA standards and guidelines when the certified registered nurse anesthetist provides a service specified in the ASA standards and guidelines to be provided by an anesthesiologist.

(e) In an outpatient setting, where a physician has delegated to a certified registered nurse anesthetist the ordering of drugs and devices necessary for the nurse anesthetist to administer an anesthetic or an anesthesia-related service ordered by a physician, a certified registered nurse anesthetist may select, obtain and administer drugs, including determination of appropriate dosages, techniques and medical devices for their administration and in maintaining the patient in sound physiologic status. This order need not be drug-specific, dosage specific, or administration-technique specific. Pursuant to a physician's order for anesthesia or an anesthesia-related service, the certified registered nurse anesthetist may order anesthesia-related medications during perianesthesia periods in the preparation for or recovery from anesthesia. In providing anesthesia or an anesthesia-related service, the certified registered nurse anesthetist shall select, order, obtain and administer drugs which fall within categories of drugs generally utilized for anesthesia or anesthesia-related services and provide the concomitant care required to maintain the patient in sound physiologic status during those experiences.

(f) The anesthesiologist or physician providing anesthesia or anesthesia-related services in an outpatient setting shall perform a pre-anesthetic evaluation, counsel the patient, and prepare the patient for anesthesia per current ASA standards. If the physician has delegated the provision of anesthesia or anesthesia-related services to a CRNA, the CRNA may perform those services within the scope of practice of the CRNA. Informed consent for the planned anesthetic intervention shall be obtained from the patient/legal guardian and maintained as part of the medical record. The consent must include explanation of the technique, expected results, and potential risks/complications. Appropriate pre-anesthesia diagnostic testing and consults shall be obtained per indications and assessment findings. Pre-anesthetic diagnostic testing and specialist consultation should be obtained as indicated by the pre-anesthetic evaluation by the anesthesiologist or suggested by the nurse anesthetist's pre-anesthetic assessment as reviewed by the surgeon. If responsibility for a patient's care is to be shared with other physicians or non-physician anesthesia providers, this arrangement should be explained to the patient.

(g) Physiologic monitoring of the patient shall be determined by the type of anesthesia and individual patient needs. Minimum monitoring shall include continuous monitoring of ventilation, oxygenation, and cardiovascular status. Monitors shall include, but not be limited to, pulse oximetry and EKG continuously and non-invasive blood pressure to be measured at least every five minutes. If general anesthesia is utilized, then an O2 analyzer and end-tidal CO2 analyzer must also be used. A means to measure temperature shall be readily available and utilized for continuous monitoring when indicated per current ASA standards. An audible signal alarm device capable of detecting disconnection of any component of the breathing system shall be utilized. The patient shall be monitored continuously throughout the duration of the procedure. Postoperatively, the patient shall be evaluated by continuous monitoring and clinical observation until stable by a licensed health care provider. Monitoring and observations shall be documented per current ASA standards. In the event of an electrical outage which disrupts the capability to continuously monitor all specified patient parameters, at a minimum, heart rate and breath sounds will be monitored on a continuous basis using a precordial stethoscope or similar device, and blood pressure measurements will be reestablished using a non-electrical blood pressure measuring device until electricity is restored. There should be in each location, sufficient electrical outlets to satisfy anesthesia machine and monitoring equipment requirements, including clearly labeled outlets connected to an emergency power supply. A two-way communication source not dependent on electrical current shall be available. Sites shall also have a secondary power source as appropriate for equipment in use in case of power failure.

(h) All anesthesia-related equipment and monitors shall be maintained to current operating room standards. All devices shall have regular service/maintenance checks at least annually or per manufacturer recommendations. Service/maintenance checks shall be performed by appropriately qualified biomedical personnel. Prior to the administration of anesthesia, all equipment/monitors shall be checked using the current FDA recommendations as a guideline. Records of equipment checks shall be maintained in a separate, dedicated log which must be made available upon request. Documentation of any criteria deemed to be substandard shall include a clear description of the problem and the intervention. If equipment is utilized despite the problem, documentation must clearly indicate that patient safety is not in jeopardy. All documentation relating to equipment shall be maintained for seven years or for a period of time as determined by the board.

(i) Each location must have emergency supplies immediately available. Supplies should include emergency drugs and equipment appropriate for the purpose of cardiopulmonary resuscitation. This must include a defibrillator, difficult airway equipment, and drugs and equipment necessary for the treatment of malignant hyperthermia if "triggering agents" associated with malignant hyperthermia are used or if the patient is at risk for malignant hyperthermia. Equipment shall be appropriately sized for the patient population being served. Resources for determining appropriate drug dosages shall be readily available. The emergency supplies shall be maintained and inspected by qualified personnel for presence and function of all appropriate equipment and drugs at intervals established by protocol to ensure that equipment is functional and present, drugs are not expired, and office personnel are familiar with equipment and supplies. Records of emergency supply checks shall be maintained in a separate, dedicated log and made available upon request. Records of emergency supply checks shall be maintained for seven years or for a period of time as determined by the board.

(j) The operating surgeon shall verify that the appropriate policies or procedures are in place. Policies, procedure, or protocols shall be evaluated and reviewed at least annually. Agreements with local emergency medical service (EMS) shall be in place for purposes of transfer of patients to the hospital in case of an emergency. EMS agreements shall be evaluated and re-signed at least annually. Policies, procedure, and transfer agreements shall be kept on file in the setting where procedures are performed and shall be made available upon request. Policies or procedures must include, but are not limited to the following listed in paragraphs (1) - (2) of this subsection:

(1) Management of outpatient anesthesia. At a minimum, these must address:

(A) patient selection criteria;

(B) patients/providers with latex allergy;

(C) pediatric drug dosage calculations, where applicable;

(D) ACLS (advanced cardiac life support) or PALS (pediatric advanced life support) algorithms;

(E) infection control;

(F) documentation and tracking use of pharmaceuticals, including controlled substances, expired drugs and wasting of drugs; and

(G) discharge criteria.

(2) Management of emergencies. At a minimum, these must include, but not be limited to:

(A) cardiopulmonary emergencies;

(B) fire;

(C) bomb threat;

(D) chemical spill; and

(E) natural disasters.

(k) Physicians, certified registered nurse anesthetists, and [ Operating surgeons or ] anesthesiologists shall maintain current competency in ACLS, PALS, or a course approved by the board. In all settings under these rules, at a minimum, at least two persons, including the surgeon or anesthesiologist, shall maintain current competency in basic life support.

(l) Physicians or surgeons must notify the board in writing within 15 days if a procedure performed in any of the settings under these rules resulted in an unanticipated and unplanned transport of the patient to a hospital for observation or treatment for a period in excess of 24 hours, or a patient's death intraoperatively or within the immediate postoperative period. Immediate postoperative period is defined as 72 hours.

§192.3.Compliance with Office-Based Anesthesia Rules.

(a) A physician who provides anesthesia services [ practices medicine in this state and who administers anesthesia ] or performs a [ surgical ] procedure for which anesthesia services are provided in an outpatient setting shall comply with the rules adopted under this title. Nothing in this chapter shall be construed to relieve a physician who delegates anesthesia services to a non-physician, including a Certified Registered Nurse Anesthetist, of professional or legal responsibility for such delegation.

(b) The board may require a physician to submit and comply with a corrective action plan to remedy or address any current or potential deficiencies with the physician's provision of anesthesia services in an outpatient setting in accordance with the Medical Practice Act, Title 3 Subtitle C §§162.101-.107 of the Texas Occupations Code, or rules of the board.

(c) Any physician who violates these rules shall be subject to disciplinary action and/or termination of the registration issued by the board as authorized by the Medical Practice Act or rules of the board.

§192.4.Registration.

(a) Each physician who provides [ administers ] anesthesia services or performs a [ surgical ] procedure for which anesthesia services are provided in an outpatient setting shall register with the board on a form prescribed by the board and pay a fee to the board in an amount established by the board.

[ (b) The physician who owns, maintains, controls, or is otherwise deemed to be responsible for the office-based anesthesia site shall pay a biennial office-based anesthesia site registration fee to the board in an amount established by the board. In the event that a non-physician or any other entity owns, maintains, controls, or is otherwise deemed to be responsible for the office-based anesthesia site, that non-physician or entity shall designate a duly licensed Texas physician to be responsible for that office-based anesthesia site. The designated physician shall be responsible for the registration of the office-based anesthesia site. ]

(b) [ (c) ] The board shall coordinate the registration required under this section with the registration required under the Medical Practice Act, Texas Occupations Code Chapter 156, so that the times of registration, payment, notice, and imposition of penalties for late payment are similar and provide a minimum of administrative burden to the board and to physicians.

§192.5.Inspections.

(a) The board may conduct inspections to enforce these rules, including inspections of an office site and of documents of a physician's practice that relate to the provision of anesthesia services in an outpatient setting. The board may contract with another state agency or qualified person to conduct these inspections.

(b) Unless it would jeopardize an ongoing investigation, the board shall provide at least five business days' notice before conducting an on-site inspection under this section.

(c) This section does not require the board to make an on-site inspection of a physician's office.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on April 17, 2006.

TRD-200602209

Donald W. Patrick, MD, JD

Executive Director

Texas Medical Board

Earliest possible date of adoption: May 28, 2006

For further information, please call: (512) 305-7016


Chapter 199. PUBLIC INFORMATION

22 TAC §199.5

The Texas Medical Board proposes new §199.5, concerning Notice of Ownership Interest in a Niche Hospital.

New §199.5 requires physicians to notify the Department of State Health Services of an ownership interest in niche hospitals and provides a form for such notification as required by the Legislature in 2005.

Michele Shackelford, General Counsel, Texas Medical Board, has determined that for the first five-year period the new section is in effect there will be no fiscal implications to state or local government as a result of enforcing the section as proposed. There will be no effect to individuals required to comply with the section as proposed.

Ms. Shackelford also has determined that for each year of the first five years the section as proposed is in effect the public benefit anticipated as a result of enforcing the section will be to provide public information regarding physician's ownership interests in niche hospitals. There will be no effect on small or micro businesses.

Comments on the proposal may be submitted to Sally Durocher, P.O. Box 2018, Austin, Texas 78768-2018. A public hearing will be held at a later date.

The new section is proposed under the authority of the Texas Occupations Code Annotated, §153.001, which provides the Texas Medical Board to adopt rules and bylaws as necessary to: govern its own proceedings; perform its duties; regulate the practice of medicine in this state; enforce this subtitle; and establish rules related to licensure.

No other statutes, articles or codes are affected by this proposal.

§199.5.Notice of Ownership Interest in a Niche Hospital.

(a) A physician shall notify the Department of State Health Services of an ownership interest held by the physician in a niche hospital as required by §162.052 of the Act.

(b) In this section, "niche hospital," as defined by §105.002, Tex. Occ. Code, means a hospital that:

(1) classifies at least two-thirds of the hospital's Medicare patients or, if data is available, all patients:

(A) in not more than two major diagnosis-related groups; or

(B) in surgical diagnosis-related groups;

(2) specializes in one or more of the following areas:

(A) cardiac;

(B) orthopedics;

(C) surgery; or

(D) women's health; and

(3) is not:

(A) a public hospital;

(B) a hospital for which the majority of inpatient claims are for major diagnosis-related groups relating to rehabilitation, psychiatry, alcohol and drug treatment, or children or newborns; or

(C) a hospital with fewer than 10 claims per bed per year.

(c) The board hereby adopts by reference the Disclosure and Consent Form, which shall be published on the board's web site and may be examined and copies obtained at the offices of the board.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on April 17, 2006.

TRD-200602210

Donald W. Patrick, MD, JD

Executive Director

Texas Medical Board

Earliest possible date of adoption: May 28, 2006

For further information, please call: (512) 305-7016


Part 17. TEXAS STATE BOARD OF PLUMBING EXAMINERS

Chapter 365. LICENSING AND REGISTRATION

22 TAC §365.14

The Texas State Board of Plumbing Examiners (Board) proposes amendments to §365.14, which provides for the criteria adopted by the Board for Continuing Professional Education Programs. Currently, §365.14(a)(7) requires providers of Course Materials to include perforated forms, used by those who do business with the Board, within the binding of the Course materials that may be removed. The amendments proposed to this section would change the requirement from the forms to be perforated for removal to the forms being included in a format to be seen as an example, not to be removed from the Course Materials.

The Board periodically reviews and updates its forms to provide new or improved information. The proposed amendments to §365.14(a)(7) will help eliminate the use of outdated perforated forms found within the Course Materials.

Robert L. Maxwell, Executive Director of the Texas State Board of Plumbing Examiners, has determined that for the first five-year period the amendments are in effect there will be no fiscal impact on state and local government or small businesses and persons required to comply with the amended rule.

Mr. Maxwell has also determined that for each year of the first five years the amendments are in effect the public benefit anticipated as a result of enforcing the amended rule will be improved efficiency for those who do business with the Board, as well as improved efficiency for the Board.

Comments on the proposed amendments may be submitted within 30 days of publication of the proposal in the Texas Register , to Robert L. Maxwell, Executive Director, Texas State Board of Plumbing Examiners, 929 East 41st Street, P.O. Box 4200, Austin, Texas 78765-4200.

The amendments to §365.14 are proposed under and affect Title 8, Chapter 1301, Occupations Code ("Plumbing License Law"), §1301.251, §1301.404 and the rule it amends. Section 1301.251 requires the Board to adopt and enforce rules necessary to administer the Plumbing License Law. Section 1301.404 provides the Board with authority to recognize, approve and administer continuing professional education programs for persons who hold licenses or endorsements under the Plumbing License Law.

No other statute, article or code is affected by these proposed amendments.

§365.14.Continuing Professional Education Programs.

(a) Course Materials--Beginning in preparation for the 2000 - 2001 Continuing Professional Education year (begins on July 1, 2000), the Board will annually approve Course Materials to be used for the Continuing Professional Education (CPE) required for renewal of Journeyman Plumber, Master Plumber, Tradesman Plumber-Limited Licensee and Plumbing Inspector Licenses. The Course Materials are the printed materials that are the basis for a substantial portion of a CPE course and which are provided to the Licensees. Board approval of Course Materials will be subject to all of the terms and conditions of this Section. The following minimum criteria will be used by the Board in considering approval of Course Materials:

(1) - (6) (No change.)

(7) The Course Materials will include CPE evaluation forms, along with Board forms used for doing business with licensees, registrants and the public. The Board forms shall be marked as being provided for example purposes only. Course Materials will provide information stating that the most current Board forms are available on the Board's website or by mail upon request [ perforated Board forms within the binding of the Course Materials that may be removed for use by the Licensees. The forms will include CPE evaluation forms, License and Endorsement examination forms, registration forms and General Complaint forms ].

(8) - (18) (No change.)

(b) - (c) (No change.)

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on April 12, 2006.

TRD-200602125

Robert L. Maxwell

Executive Director

Texas State Board of Plumbing Examiners

Earliest possible date of adoption: May 28, 2006

For further information, please call: (512) 936-5224