TMB rules you may not know but should, Part 2

by Dan Ballard, JD and Stacey Simmons, JD

This is the second in a series of articles about specific Texas Medical Board (TMB) 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. In this article, new death certificate requirements, standing delegation rules, and office-based anesthesia rules will be reviewed.

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. The TMB 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.  (1)

6. SUPERVISING MID-LEVEL PRACTIONERS

The rules related to the supervision of mid-level 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 web site (http://www.tmb.state.tx.us/rules/rules.php). (2)

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. (3) Note however, that Rule 185.16 states that the physician must be on site with the physician's assistant at least 10% of the time, though there is an exception provided for medically under-served areas. (4) The Medical Practice Act, Section 157.0541, further requires that the supervising physician must review 10% of the charts of mid-level practitioners who are located at a site other than the physician's primary practice site. (5)

Regarding documentation of supervision of mid-levels at non-primary sites, Medical Board Rule 193.6(f)(2) requires "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's assistant or advanced practice nurse. The supervising physician shall sign the documentation at the conclusion of each site visit." (6)

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

The Medical Practice Act, Section 157.053 allows for delegation of prescribing authority to mid-levels 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 mid-level practitioner's experience and expertise. (7) Medical Board Rule 193.6 specifies that mid-level 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

Medical Board Rule 185.16 limits to five the number of physician's assistants or their full-time equivalents (up to 50 hours per week) that one physician may supervise. (9) 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's assistants or advanced practice nurses or their full-time equivalents practicing at the physician's primary practice site or at an alternate practice site. (10) The Medical Practice Act, Section 157.0541(e) also places a limit of four on the number of mid-level practitioners who can be located at non-primary sites of practice of the supervising physician. This would include a combination of both physician's assistants and advanced practice nurses. (11)

Any physician who practices in a hospital environment and employs physician's 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 mid-level 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 mid-level 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:

1. the physician assistant's scope of practice is identified;
2. delegation of medical tasks is appropriate to the physician assistant's level of competence;
3. the relationship between the members of the team is defined;
4. the relationship of, and access to, the supervising physician is defined;
5. a process for evaluation of the physician assistant's performance is established; and

Each of these items should be covered in a written document. This same rule also states that "Physician's 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's assistant is obtained by specific delegation from his or her supervising physician. (13)

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 mid-level practitioner lacked competence, rather than imposing a "should have known" or "should have believed" standard. (14)

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. (15)

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:

1. bag mask valve;
2. oxygen; and
3. AED or other defibrillator; and
4. epinephrine, atropine, adrenocorticoids, and antihistamines. 16"

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). (16)

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. (17) Rule 192.2(j) also requires that written protocols must be adopted that cover at least the following subjects:

1. patient selection criteria;
2. patients/providers with latex allergy;
3. pediatric drug dosage calculations, where applicable;
4. ACLS or PALS algorithms;
5. infection control;
6. documentation and tracking use of pharmaceuticals, including controlled substances, expired drugs and wasting of drugs; and
7. discharge criteria. (18)

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

1. cardiopulmonary emergencies;
2. fire;
3. bomb threat;
4. chemical spill; and
5. natural disasters. (18)

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. (19)

Finally, it should be noted that a clinic must be registered with the TMB if the majority of its patients are treated for pain management issues. The specific requirement under Medical Board 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." (20)

8. YOUR INSURANCE COVERAGE FOR REGULATORY/LEGAL ACTIONS ARISING OUT OF YOUR MEDICAL PRACTICE

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 non-compliance with Medicare/Medicaid regulations. In addition, reimbursement for individual federal tax audits is covered.

Notify TMLT as soon as you receive the initial letter from the TMB or other disciplinary authority. The policy states 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 TMLT representative in any legal proceeding involving your medical practice, the better your result will be.

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.

SOURCES

1. Texas Health and Safety Code, Title 3, Chapter 193, Section 193.005. Available at https://statutes.capitol.texas.gov/Docs/HS/htm/HS.193.htm. Accessed April 12, 2024.
2. Texas Medical Board. Medical Board Rules. Available at https://www.tmb.state.tx.us/page/board-rules . Accessed April 12, 2024.
3. Texas Medical Board. Medical Board Rule 185.14(a). Available at https://www.tmb.state.tx.us/page/board-rules . Accessed April 12, 2024.
4. Texas Medical Board. Medical Board Rule 185.16(c). Available at https://www.tmb.state.tx.us/page/board-rules . Accessed April 12, 2024.
5. Medical Practice Act. Section 157.0541. Available at https://www.tmb.state.tx.us/page/practice-acts. Accessed April 12, 2024.
6. Texas Medical Board. Medical Board Rule 193.6(f)(2).Available at https://www.tmb.state.tx.us/page/board-rules . Accessed April 12, 2024.
7. Medical Practice Act. Section 157.0. Available at https://www.tmb.state.tx.us/page/practice-acts. Accessed April 12, 2024.
8. Texas Medical Board. Medical Board Rule 193.6. Available at https://www.tmb.state.tx.us/page/board-rules . Accessed April 12, 2024.
9. Texas Medical Board. Medical Board Rule 185.16. Available at https://www.tmb.state.tx.us/page/board-rules . Accessed April 12, 2024.
10. Medical Practice Act. Section 157.053(e)(1). Available at https://www.tmb.state.tx.us/page/practice-acts. Accessed April 12, 2024.
11. Medical Practice Act. Section 157.0541(e). Available at https://www.tmb.state.tx.us/page/practice-acts. Accessed April 12, 2024.
12. Texas Medical Board. Medical Board Rule 185.14(b). Available at https://www.tmb.state.tx.us/page/board-rules . Accessed April 12, 2024.
13. Texas Medical Board. Medical Board Rule 193.6 (f). Available at https://www.tmb.state.tx.us/page/board-rules . Accessed April 12, 2024.
14. Medical Practice Act. Section 157.060. Available at https://www.tmb.state.tx.us/page/practice-acts. Accessed April 12, 2024.
15. Texas Medical Board. Medical Board Rule 192. Available at https://www.tmb.state.tx.us/page/board-rules . Accessed April 12, 2024.
16. Texas Medical Board. Medical Board Rule 192.2(c). Available at https://www.tmb.state.tx.us/page/board-rules . Accessed April 12, 2024.
17. Texas Medical Board. Medical Board Rule 192.4. Available at https://www.tmb.state.tx.us/page/board-rules . Accessed April 12, 2024.
18. Texas Medical Board. Medical Board Rule 192.2(j). Available at https://www.tmb.state.tx.us/page/board-rules . Accessed April 12, 2024.
19. Texas Medical Board. Medical Board Rule 192.4(l). Available at https://www.tmb.state.tx.us/page/board-rules . Accessed April 12, 2024.
20. Texas Medical Board. Medical Board Rule 195.1. Available at https://www.tmb.state.tx.us/page/board-rules . Accessed April 12, 2024.

Stacey Simmons and Dan Ballard are partners with Ballard & Simmons, LLP. Stacey Simmons can be reached at staceysimmons@ballardfirm.com. Dan Ballard can be reached at danballard@ballardfirm.com.