TMB rules you may not know but should . . . part 1

Tags: advertising, texas medical board, rule, relocation, documentation, texas medical liability trust, prescription

TMB rules you may not know but should

By TMLT Risk Management Department

Texas Medical Board rules, which regulate the activities of Texas physicians, consist of 156,165 words on 244 single-spaced pages. While most physicians are familiar with the basic concepts of these regulations, there are several specific rules that seem to give physicians the most trouble.

This article will discuss these more challenging TMB rules in an effort to enhance knowledge of the TMB, reduce exposure to disciplinary actions by the board, and assist in the physician’s defense should a TMB action occur. It will address physician advertising, actions to take when leaving a medical practice, documentation of patient encounters, documentation of prescriptions, new death certificate requirements, standing delegation rules, and office-based anesthesia rules.

1. Physician advertising

The TMB has established rules for use of the term “board certified” in advertising. “A physician is authorized to use the term ‘board certified’ in any advertising for his or her practice only if the specialty board that conferred the certification and the certifying organization is a member board of the American Board of Medical Specialties, or the Bureau of Osteopathic Specialists, or is the American Board of Oral and Maxillofacial Surgery.” Physicians may advertise certification by other types of organizations only if the organization meets certain requirements, as specified in TMB advertising rules.1

These rules also expressly prohibit use of the terms “board eligible” or “board qualified” in physician advertising. The board has determined that these terms are misleading and cause confusion about a physician’s board certification status.1

TMB rules also expressly prohibit advertising that is “in any way false, deceptive, or misleading.” Any statement made about the physician’s professional experience, competence, or quality should only be made if it can be supported by facts.1 For example, if a physician were to say in an ad that he was “among the most highly qualified neurosurgeons in the southwest,” then he must have objective data to support the comparison of his qualifications to the other neurosurgeons in the southwest. Because it is unlikely that the neurosurgeon has data to support this statement, its use should be avoided.1

Do not advertise the sale of products—any products—according to TMB rule 164.6(c). “Advertising or promotion of goods or products from which the physician receives direct remuneration or incentives is prohibited.” This prohibition appears to encompass nutritional supplements, cosmetics, eyeglasses, hearing aids, and other products commonly sold at physicians’ offices. It is unclear if the rule is intended to include products that must be injected or surgically installed, such as Botox or implantable medical devices.

Further, we interpret the rule to include instances in which the physician’s website advertises a product that is not for sale by the physician, but his website links to a third-party website for purchase of the product. If use of the link by the patient allows the physician to be paid a fee by the third-party seller, then the physician is receiving direct remuneration for sale of the product.1

Physicians planning to advertise, whether through a website, Yellow Pages ad, or television commercial, should become familiar with the TMB’s rules for physician advertising.

Editor’s note: On May 5, 2011, as this article was being published, the TMB changed the language of the advertising rule. The rule now states: “(c) Advertising/Promotion of Goods or Products. Advertising or promotion of goods or products that a licensee sells outside the normal course of business from which the physician receives direct remuneration or incentives is prohibited.” This appears to be a substantial reduction of the previous prohibition regarding the advertising of products for sale. We do not yet have clarification of exactly what this is intended to mean.

Additionally, we have been in contact with the TMB regarding the new rule and we believe that it contains an error that the TMB will remedy in the upcoming months. The error pertains to the new subsection (d) of rule 164.6 that states: “(d) This section applies only to licensees who bill for services provided via the Internet.”

This new subsection could be interpreted to mean that the newly modified advertising rule will apply only if you bill for services provided via the Internet. We have information from the TMB that they did not intend to limit the advertising prohibition in this way. We believe they will remedy this error. The outcome may be that all physicians will be limited to advertising products that they sell in the normal course of business, and no physician may advertise products that they sell outside the normal course of business.

2. Leaving a medical practice

The board rules found in section 165 are lengthy and complex. Among other issues, this rule describes how physicians should notify patients that they are leaving their current practice site. The most interesting sentence in this rule is found in Section 165.5(e), which makes it a criminal violation to violate any part of this rule. Hard to believe, but true.

This rule specifies what actions must be taken when a physician leaves his or her current practice. The departing physician must do three things: send letters to all patients seen in the last two years notifying them of the change in the practice, post a prominent notice in the office for 30 days before the change, and publish a notice in the largest local newspaper. The departing physician’s failure to comply with this rule is often brought to the attention of the board by a patient who is contacting the board because the physician’s former practice will not tell the patient where to find the physician. Any time physicians begin contemplating a move or retirement, it may be helpful to begin gathering the names and addresses of active patients as they are seen in the office.

Interestingly, there are only two requirements for the remaining members of the group. They must stay out of the way of the departing physician and give the departing physician access to the information he or she needs to provide proper notice to patients.2

3. Documentation

Board rule 165 also requires proper charting of each “patient encounter.” Proper charting includes a SOAP note or its equivalent, the date, and the legible identity of the physician. It is important to note that the rule does not just require the identity of the physician, but specifically requires the “legible identity.”

What constitutes a patient encounter? If a physician takes a phone call from the patient of his or her call partner, is that a patient encounter that must be charted? How is the encounter charted when the physician does not have access to the patient’s chart?

In general, it is a patient encounter if the physician received medical information from the person and gave medical advice in return. Even if the advice was simply to go to the emergency department, that is a patient encounter. Brief phone consultations are also considered patient encounters that need to be charted.2

A good solution for charting these encounters—even if the physician was covering call for another physician—is to have a designated voicemail box that the physician can call to leave a dictated message. The dictated message can later be turned into a chart note and faxed or e-mailed to the patient’s physician. This simple system satisfies the charting rule while promoting continuity of care.

Of special note is the potential misuse of electronic medical records or of any other type of charting system that facilitates the use of “default” text in a patient’s chart. “Default text” is any pre-inserted text that will remain in the chart unless changed by the user. Some EMRs use language describing “normal findings” in the review of systems. If this default language is not altered, it will remain in the chart indicating that the physician completed a review of systems. If this review of systems was not done or if the findings were not normal and the EMR defaults to “normal,” the record is inaccurate.

During the investigation of a medical liability claim or a board complaint, it is often apparent that these default statements are not true regarding the patient in question, implying that the examination of the patient was incomplete or the charting was sloppy.

4. Documenting prescriptions

Board rule 165.1 requires that the chart should include documentation of prescriptions (including samples) specifying the amount, frequency, number of refills, and dosage. While it may seem obvious to include these details in the chart, it is often the case that the total amount of medication prescribed cannot be determined from the medical record. In most cases when we are defending a physician, we must obtain the pharmacy records to determine dosage, frequency, and number of refills for a medication.

The lack of information in the chart becomes a problem most often when there are allegations of failure to adequately control or monitor medications. When members of the TMB review the chart and cannot determine the number of pills prescribed, they conclude that the physician cannot determine this either. Along with properly charting that drug samples were given to the patient, physicians should maintain records of samples obtained from drug companies for two years.2

Best practices in charting prescriptions require the physician to keep a medication list for each patient that is updated at each visit. This list should include all medications the patient reports taking. If this information is not easily accessible, adverse drug reactions can occur.

In regard to Schedule II drug prescriptions, avoid post-dating prescriptions. A post-dated prescription for any controlled substance is illegal. The proper way to write a controlled substance prescription to be filled at a later date is to write today’s date and then also write the future date along with the words “earliest fill date.” The new official prescription forms from the Department of Public Safety prompt the physician to write both dates. Pre-signing a Schedule II prescription pad is illegal. The signature must be written at the same time or after the remainder of the prescription is written.3

The TMB also prohibits the prescription of controlled substances for more than 72 hours to oneself, family members, or others in which there is a close personal relationship. This rule covers prescriptions for medications such as zolpidem, amphetamine and dextroamphetamine, diazepam, alprazolam, and hydrocodone.4

5. New death certificate requirements

Texas physicians who are asked to sign a death certificate must now do so electronically or face fines from the TMB of up to $500 per violation. House Bill 1739—which took effect in 2007—requires a medical certifier on a death certificate to submit the medical certification and attest to its validity electronically.

Physicians must register with the Texas Electronic Death Registrar (TEDR) before signing a death certificate. Any physician who signs a paper death certificate because he or she is not registered with TEDR could be fined $500 by the TMB. The Texas Department of State Health Services operates the TEDR.

Physicians should also note that signing a paper death certificate—even if you are registered with the TEDR—is now considered illegal. Therefore, sign up for the electronic system so you will not have to sign a paper death certificate. It is currently taking about two weeks to process a physician’s electronic registration through the TEDR. If you wait and try to sign up after a patient dies, it will be too late and you could be fined. Though the legislation went into effect in 2007, the TMB began enforcing it in 2011. And although the Board put enforcement on hold in late 2010, they recently restarted enforcement.5

6. Supervising midlevel practitioners

The rules related to the supervision of midlevel practitioners are focused primarily on requiring written delegation of responsibilities and active follow-through with supervision. The applicable rules are found mainly in Texas Medical Board Rules 185 and 193.6, and the Medical Practice Act, Section 157 (also known as the Texas Occupations Code). All of these rules can be found at the Texas Medical Board website, www.tmb.state.tx.us/rules/rules.php.6

TMB rules require “continuous” supervision of physician assistants, but the rules make it clear that this does not require the physician’s continuous physical presence. The physician must always be available by phone.7 Note however, that rule 185.16 states that the physician must be on-site with the physician assistant at least 10 percent of the time, though there is an exception provided for medically underserved areas.8 The Medical Practice Act, Section 157.0541, further requires that the supervising physician must review 10 percent of the charts of midlevel practitioners who are located at a site other than the physician’s primary practice site.9

Regarding documentation of supervision of midlevels at non-primary sites, board rule 193.6(f)(2) requires the following.

“If the physician assistant or advanced practice nurse is located at a site other than the site where the physician spends the majority of the physician’s time, physician supervision shall be further documented by a permanent record showing the names or identification numbers of patients discussed during the daily status reports, the times when the physician is on-site, and a summary of what the physician did while on-site. The summary shall include a description of the quality assurance activities conducted and the names of any patients seen or whose case histories were reviewed with the physician assistant or advanced practice nurse. The supervising physician shall sign the documentation at the conclusion of each site visit.”10

Notably, this rule also specifically states that this type of documentation is not required for midlevels practicing on-site at the physician’s primary practice site.

The Medical Practice Act, section 157.053 allows for delegation of prescribing authority to midlevels as long as there is a written standing order or protocol in place that defines the parameters of the prescribing authority. The act implies that the delegation of prescribing authority should be commensurate with each midlevel practitioner’s experience and expertise.11 Board rule 193.6 specifies that midlevel practitioners may neither write prescriptions for Schedule II drugs nor write a prescription for more than 90 days for any Schedule III, IV, or V drug. This same rule requires that “A physician shall document any delegation of prescriptive authority to a physician assistant or advanced practice nurse by a protocol, as defined in this section.”12

Medical board rule 185.16 limits to five the number of physician assistants or their full-time equivalents (up to 50 hours per week) that one physician may supervise.13 Importantly however, the Medical Practice Act, section 157.053(e)(1) states that with respect to prescribing practices, the supervising physician may delegate prescription authority to only four physician assistants or advanced practice nurses or their full-time equivalents practicing at the physician’s primary practice site or at an alternate practice site.14 The Medical Practice Act, section 157.0541(e) also places a limit of four on the number of midlevel practitioners who can be located at non-primary sites of practice of the supervising physician. This would include a combination of both physician assistants and advanced practice nurses.15

Any physician who practices in a hospital environment and employs physician assistants to help take care of hospitalized patients must consider whether they (the physicians) are sufficiently available to cover acute problems that may be identified by the midlevel practitioner. For example, the question needs to be asked whether it would be appropriate for a surgeon to operate on a patient and then leave town, leaving the midlevel practitioner to monitor the patient and communicate with the physician if problems arise. This arrangement generally works satisfactorily until the need for a second procedure arises. In such a situation, it is necessary to arrange surgical coverage before becoming physically unavailable. In other words, supervision by phone will not always suffice.

With respect to the requirement for written protocols, medical board rule 185.14(b) states: “It is the obligation of each team of physician(s) and physician assistant(s) to ensure that:

  • the physician assistant’s scope of practice is identified;
  • delegation of medical tasks is appropriate to the physician assistant’s level of competence;
  • the relationship between the members of the team is defined;
  • the relationship of, and access to, the supervising physician is defined;
  • a process for evaluation of the physician assistant’s performance is established; and
  • the physician assistant’s annual registration permit is current.”16

Each of these items should be covered in a written document. This same rule also states that “Physician assistants must utilize mechanisms which provide medical authority when such mechanisms are indicated, including, but not limited to, standing delegation orders, standing medical orders, protocols, or practice guidelines.” Medical board rule 193.6(f) also requires that “The physician shall also maintain a permanent record of all protocols the physician has signed, showing to whom the delegation was made and the dates of the original delegation, each annual review, and termination.” The important point to keep in mind at all times is that basically all authority of a physician assistant is obtained by specific delegation from his or her supervising physician.17

An interesting provision of the Medical Practice Act provides at least some degree of protection from liability for supervising physicians. Section 157.060 states, “Unless the physician has reason to believe the physician assistant or advanced practice nurse lacked the competency to perform the act, a physician is not liable for an act of a physician assistant or advanced practice nurse solely because the physician signed a standing medical order, a standing delegation order, or another order or protocol authorizing the physician assistant or advanced practice nurse to administer, provide, carry out, or sign a prescription drug order.” The noteworthy aspect of this section is that the legal standard it imposes is whether the physician “has reason to believe” the midlevel practitioner lacked competence, rather than imposing a “should have known” or “should have believed” standard.18

7. Office-based anesthesia

This discussion applies primarily to outpatient, ambulatory, non-accredited clinic facilities that require control of pain or anxiety during treatment by some means other than using local anesthesia or a nerve block. The general purpose of the rule is to first classify procedures into four different levels depending upon the type of anxiolytic, analgesic, or anesthetic being used (either before, during, or after the procedure). The rule then sets forth standards for the level of personnel training and the availability of equipment for each level of care. The rules applicable to this discussion are found in Texas Medical Board rule 192.19

First, it may be helpful to give an example of a common situation that illustrates the very broad applicability of this rule. If you give a patient a single tablet of alprazolam to take before removing a mole or performing a cosmetic laser procedure, this rule applies. You will need to comply with the personnel training and resuscitation equipment requirements of the rule. The rules classify this as a Level I situation, which is the lowest of the four levels. In all settings covered by the office-based anesthesia rules, the physician and at least one other person present must maintain certification in basic cardiac life support (BCLS).

Medical board rule 192.2(c) provides that in a situation in which a Level I service is being provided, the following requirements must also be met:

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

  • bag mask valve;
  • oxygen;
  • AED or other defibrillator; and
  • epinephrine, atropine, adrenocorticoids, and antihistamines.”20

Level II services are those in which there is delivery of analgesics or anxiolytics by mouth in dosages greater than allowed at Level I or there is use of tumescent anesthesia. Provision of Level II services requires a higher level of certification of personnel and more sophisticated equipment. For example, the physician must be ACLS (advanced cardiac life support) or PALS (pediatric advanced life support) certified, and there must be an EKG machine and a crash cart available (among other additional requirements).20

Medical Board rule 192.4 requires that any physician providing Level II, III, or IV services must register with the board and pay a fee.21 Rule 192.2(j) also requires that written protocols must be adopted that cover at least the following subjects:

  • patient selection criteria;
  • patients/providers with latex allergy;
  • pediatric drug dosage calculations, where applicable;
  • ACLS or PALS algorithms;
  • infection control;
  • documentation and tracking use of pharmaceuticals, including controlled substances, expired drugs, and wasting of drugs; and
  • discharge criteria.22

At a minimum, management of emergencies must include, but not be limited to:

  • cardiopulmonary emergencies,
  • fire,
  • bomb threat,
  • chemical spill, and
  • natural disasters.22

A very important requirement provided by rule 192.4(l) is that “All equipment and anesthesia-related services must remain available at the office-based anesthesia site until the patient is discharged.” This could easily be interpreted to mean that the physician must remain on-site until the patient goes home.23

Finally, it should be noted that since Sept. 1, 2010, a clinic must be registered with the TMB if the majority of its patients are treated for pain management issues. The specific requirement under rule 195 is for registration if the “majority of patients are issued, on a monthly basis, a prescription for opioids, benzodiazepines, barbiturates, or carisoprodol, but not including suboxone.”24

Registration for OBA will be combined with the physician’s biennial registration. If you need to register to provide OBA services between registrations, please contact Pre-Licensure, Registration, and Consumer Services at (512) 305-7030, for the proper forms. The fee to register is $210.

Editor’s note: Since the publication of this article, there was a considerable discussion about whether physicians who provide tumescent anesthesia for either liposuction or for vascular ablation procedures are covered by these rules if they are not also providing patients with other analgesics or anxiolytics. We believe that the intent of the rules is that Level II anesthesia includes tumescent anesthesia even if other analgesics or anxiolytics have not been given, otherwise there would be an unintended gap in the rules.

Many physicians who use tumescent anesthesia are trying to interpret the rule to mean that if they use only tumescent anesthesia (and they do not also use an analgesic or anxiolytic), they are not covered by the rule. We suspect that the TMB will clarify the rule to say that Level II anesthesia includes delivery of analgesics or anxiolytics by mouth in dosages greater than allowed at Level I or delivery of tumescent anesthesia.

Conclusion

With its mission to protect the public and ensure a sufficiently trained physician workforce, the TMB is poised to enforce all rules for which it has responsibility. The practice of medicine is highly regulated and each licensed physician needs to be aware of current TMB guidelines and rules. All TMLT policies that cover individual physicians include a Medefense Endorsement, which provides reimbursement for legal expenses for disciplinary proceedings and various audits. Medefense provides coverage for any action by the TMB, a hospital action regarding clinical privileges, actions by the Texas Department of State Health Services or the U.S. Department of Health and Human Services, and noncompliance with Medicare/Medicaid regulations. In addition, reimbursement for individual federal tax audits is covered.

Notify your medical liability carrier as soon as you receive the initial letter from the TMB or other disciplinary authority. TMLT policies state that a policyholder has 60 days to report an insured event to receive reimbursement for covered expenses. To preserve coverage, it is extremely important to pay attention to the 60-day window in which to report knowledge of a proceeding. Retaining an attorney at the very beginning of any regulatory process will allow the attorney to guide you in providing the best response possible. The sooner you involve a representative from your medical liability carrier in any legal proceeding involving your medical practice, the better your result will be.

  1. Texas Medical Board. Board Rules. Texas Administrative Code, Title 22, Part 9, Chapter 164, section 164.1-164.6. Available at http://www.tmb.state.tx.us/rules/rules/bdrules_toc.php. Accessed March 11, 2011.
  2. Texas Medical Board. Board Rules. Texas Administrative Code, Title 22, Part 9, Chapter 165, section 165.1-165.6 Available at http://www.tmb.state.tx.us/rules/rules/bdrules_toc.php. Accessed March 11, 2011.
  3. Health and Safety Code. Section 481.075 (1) (2). Available at http://www.statutes.legis.state.tx.us/docs/hs/htm/hs.481.htm. Accessed March 17, 2011.
  4. Texas Medical Board. Board Rules. Texas Administrative Code, Title 22, Part 9, Chapter 190, section 190.8(1)(M)(ii). Available at http://www.tmb.state.tx.us/rules/rules/bdrules_toc.php. Accessed March 11, 2011.
  5. Health and Safety Code, Title 3, Chapter 193, Section 193.005. Available at http://codes.lp.findlaw.com/txstatutes/HS/3/193/193.005. Accessed May 20, 2011.
  6. Texas Medical Board. Medical Board Rules. Available at http://www.tmb.state.tx.us/rules/rules.php. Accessed May 17, 2011.
  7. Texas Medical Board. Medical Board Rule 185.14(a). Available at http://www.tmb.state.tx.us/rules/rules.php. Accessed May 12, 2011.
  8. Texas Medical Board. Medical Board Rule 185.16(c). Available at http://www.tmb.state.tx.us/rules/rules.php. Accessed May 12, 2011.
  9. Medical Practice Act. Section 157.0541. Available at http://www.statutes.legis.state.tx.us/?link=OC. Accessed May 16, 2011.
  10. Texas Medical Board. Medical Board Rule 193.6(f)(2). Available at http://www.tmb.state.tx.us/rules/rules.php. Accessed May 16, 2011.
  11. Medical Practice Act. Section 157.0. Available at http://www.statutes.legis.state.tx.us/?link=OC. Accessed May 17, 2011.
  12. Texas Medical Board. Medical Board Rule 193.6. Available at http://www.tmb.state.tx.us/rules/rules.php. Accessed May 17, 2011.
  13. Texas Medical Board. Medical Board Rule 185.16. Available at http://www.tmb.state.tx.us/rules/rules.php. Accessed May 17, 2011.
  14. Medical Practice Act. Section 157.053(e)(1). Available at http://www.statutes.legis.state.tx.us/?link=OC. Accessed May 17, 2011.
  15. Medical Practice Act. Section 157.0541(e). Available at http://www.statutes.legis.state.tx.us/?link=OC. Accessed May 17, 2011.
  16. Texas Medical Board. Medical Board Rule 185.14(b). Available at http://www.tmb.state.tx.us/rules/rules.php. Accessed May 17, 2011.
  17. Texas Medical Board. Medical Board Rule 193.6 (f). Available at http://www.tmb.state.tx.us/rules/rules.php. Accessed May 17, 2011.
  18. Medical Practice Act. Section 157.060. Available at http://www.tmb.state.tx.us/rules/codes/chapter157.php#157060. Accessed June 28, 2011.
  19. Texas Medical Board. Medical Board Rule 192. Available at http://www.tmb.state.tx.us/rules/rules.php. Accessed May 17, 2011.
  20. Texas Medical Board. Medical Board Rule 192.2(c). Available at http://www.tmb.state.tx.us/rules/rules.php. Accessed May 17, 2011.
  21. Texas Medical Board. Medical Board Rule 192.4. Available at http://www.tmb.state.tx.us/rules/rules.php. Accessed May 17, 2011.
  22. Texas Medical Board. Medical Board Rule 192.2(j). Available at http://www.tmb.state.tx.us/rules/rules.php. Accessed May 17, 2011.
  23. Texas Medical Board. Medical Board Rule 192.4(l). Available at http://www.tmb.state.tx.us/rules/rules.php. Accessed May 17, 2011.
  24. Texas Medical Board. Medical Board Rule 195.1. Available at http://www.tmb.state.tx.us/rules/rules.php. Accessed May 17, 2011.

The information and opinions in this article should not be used or referred to as primary legal sources nor construed as establishing medical standards of care for the purposes of litigation, including expert testimony. The standard of care is dependent upon the particular facts and circumstances of each individual case and no generalization can be made that would apply to all cases. The information presented should be used as a resource, selected and adapted with the advice of your attorney. It is distributed with the understanding that neither Texas Medical Liability Trust nor Texas Medical Insurance Company is engaged in rendering legal services.

© Copyright 2011 TMLT.