TITLE 22. EXAMINING BOARDS

PART 9. TEXAS MEDICAL BOARD

CHAPTER 195. PAIN MANAGEMENT CLINICS

22 TAC §195.3

The Texas Medical Board ("Board") adopts amendments to §195.3, concerning Inspections with changes to the proposed text as published in the November 3, 2017, issue of the Texas Register (42 TexReg 6117). The text of the rule will be republished.

The Board sought stakeholder input from the Enforcement Stakeholder Group on September 21, 2017. Some of the stakeholder input was incorporated into proposed rules published in the November 3, 2017 issue of the Texas Register (42 TexReg 6117).

The amendment to §195.3 implements the legislature's intent, expressed in SB 315, to expand the TMB's authority to help combat the "public health crisis" stemming from "deaths resulting from the use of opioids and other controlled substances," by "closely regulating the prescribing of opioids and other controlled substances by physicians and their delegates." The amendment carries out the legislature's intent that the TMB inspect clinic and facilities not certified as pain clinics under Chapter 168.101 of the Medical Practice Act, to determine if such clinics should be certified, and to bring disciplinary action against clinics that have failed to meet the certification requirements or have violated other provisions of the Medical Practice Act or board rules. The amendment additionally clarifies the legislature's intent that subpoenas requiring immediate production, inspection, and copying of medical and billing (subpoenas instanter) are authorized in Board inspections and investigations in order to protect the public health and welfare. The amendments additionally fulfill the legislature's instruction to establish by rule the grounds for conducting an inspection of an uncertified pain clinic. Finally, the rules recognize the legislature's new grant of authority to the Board to enforce compliance with Board subpoenas by filing a suit to enforce compliance in district court.

Changes in the published rule, summarized below, respond to public comments or otherwise reflect non-substantive variations from the published rule. General Counsel Scott Freshour advises that the changes to the rule affect no new persons, entities, or subjects other than those given notice and that compliance with the adopted sections will not be more burdensome than under the proposed rules as published. The text of the amendments will be republished.

The Board received written comments from the Texas Medical Association (TMA) and Texas Academy of Family Physicians (TAFP) (filed jointly), The Texas Pain Society, the Texas Orthopaedic Association, and an individual orthopedic surgeon. The TMA and TFP, Texas Pain Society, and Texas Orthopaedic Association comments opposed adopting the rule as proposed and called for the Board to hold additional stakeholder meetings, as well proposing amended language.

Section 195.3(b):

TMA /TAFP Comment: The TMA/TAFP comments that §195.3(b), which authorizes the board to inspect certified pain management clinics to determine if the clinics are being operated in compliance with "applicable law and rules" exceeds statutory authority for inspections of certified pain clinics. The TMA/TAFP proposes that amending the proposed rule to specify that inspections under proposed subsection (b) are to ensure compliance with Chapter 168 of the Medical Practice Act and not "applicable law and rules."

The TMA/TAFP further comments that the sentence that states if "If other violations of the Medical Practice Act or board rules" are found during an inspection the board may bring an enforcement action for the violations, causes confusion and could suggest that to a clinic receiving a notice of inspection, that the inspection itself indicates an existing violation. The TMA/TAFP suggest amending the language by inserting the phrase "if the board finds a violation of the Medical Practice Act or board rules other than a violation related to Chapter 168 of the Medical Practice Act."

The TMA/TAFP additionally comments that the sentence authorizing the board to utilize the services of another state or local agency as needed, in carrying out inspections, is overly broad and needs to be narrowed to help clinics subject to inspections better anticipate what to expect during an inspection. The TMA/TMFP suggests amending the rule to give examples of the specific types of agencies that may assist the Board or otherwise narrowing this authorization.

Board Response: The Board disagrees with the TMA that the language in §195.3(b) exceeds the statutory authority for inspections of pain management clinics and declines to adopt the language proposed by TMA\TAFP. The Board points out that the purpose for certification under Chapter 168 is to insure that physicians operating pain management clinics are complying with applicable law and rules regarding proper and therapeutic prescribing of opioids, benzodiazepines, barbiturates, or carisoprodol. Certification under Chapter 168 is not an end in itself, but a means of insuring that physicians treating a majority of their patients for chronic pain are complying with applicable law and board rules regarding prescribing. The comments of the TMA\TAFP imply that the Board's disciplinary authority following a clinic inspection would be limited to disciplinary violations involving failure to certify and ignores the legislature's clear intent expressed in §168.003 that the Board confront the public health crisis posed by overdose deaths related to opioids and other controlled substances by "closely regulating the prescribing of opioids and other controlled substances by physicians and their delegates." For example, if a Board inspection revealed not only a failure to comply with the requirements of Chapter 168, but evidence of pre-signed prescriptions pads, use of unlicensed foreign medical graduates, rampant non therapeutic prescribing, and evidence of diversion, the Board would not be able to investigate the prescribing related violations or take disciplinary action for such violations. This was clearly not the legislature's intent. The primary purposes of inspecting a certified pain clinic is to insure that the clinic is continuing to meet the requirements of Chapter 168, however, the board retains the express authority to bring a disciplinary action for any violation of the Medical Practice Act or board rules discovered during an investigation of a licensee or during the inspection of a certified clinic.

The Board has addressed the TMA\TAFP's concerns that "other violations of the Medical Practice Act of board rules", might suggest an inspection indicates an existing violation by deleting "other."The sentence as amended makes clear that the Board may bring an enforcement action for violations of the Medical Practice or Board rules found during an inspection, including violations of Chapter 168.

The Board declines to amend the language of §195.3(b) to include specific examples of the types of agencies that may assist the Board in carrying out an inspection. The Board's decision to utilize the assistance of other agencies in carrying out an inspection does not alter the Board's procedure for performing such inspections. Moreover, this is a long-standing provision under Chapter 168 that was unchanged by SB 315.

Section 195.3(c):

TMA\TAFP Comment: The TMA/TAFP comments that §195.3(c) raises the same implication that a violation automatically occurs upon an inspection through its use of the phrase "in addition to a registration violation." The TMA then comments that §195.3(c) should be amended to correct an erroneous reference to a "egistration"violation rather than a "certification" violation.

Board Response:

The Board has incorporated the TMA\TAFP's suggestions concerning the erroneous use of the term "registration violation" and substituted the proper term certified in §195.3(c), §195.3(d)(3), §195.3(e), and §195.3(h). The Board also responded to the TMA\TAFP's concern about the phrase "in addition to a registration violation," by adding new language that the Board may bring a disciplinary action for failure to certify the clinic as required by Chapter 168, if applicable, and also disciplinary actions for other violations of the Medical Practice Act or board rules found during the inspection.

Section 195.3(d):

TMA\TAFP Comment: The TMA comments that §195.3(d) should be reconsidered to more accurately identify characteristics of clinics that have not been properly certified to avoid needless disruptions of patient care. The TMA further comments that the provisions of subsection (d) raise significant concerns that the "broadness and vagueness" of the proposed rule may interfere with legitimate prescribing and disrupt patient care.

The TMA further comments that the threshold for inspections, that the Board must meet at least one of the eight criteria listed in §195.3(d) before conducting an inspection, is too low. The TMA\TAFP opines that the board is likely to identify clinics operating within the bound of the law, which will be subject to intrusive inspections. The TMA\TAFP further states that "he existence of one criteria should not automatically trigger an inspection."The TMA\TAFP suggests that the Board should consider all relevant criteria which should provide the basis for an objective reasonable belief before the board inspects a clinic.

The TMA\TAFP further states that "the threshold for an inspection should be perfectly clear and easy to understand, for the benefit of both the board and clinics." The TMA\TAFP did not offer suggested language, but rather simply urged that the rule not be adopted and that returned to an additional stakeholder meeting.

Board Response:

The Board addressed the TMA\TAFP's concern that at least one of the eight criteria listed in §195.3(d) must be present before an inspection was too low of a threshold by deleting the sentence. The sentence describing the threshold for conducting an inspection under §195.3(c) was revised by deleting "suspects," substituting the phrase "reasonably believes," substituting the phrase "has not been properly certified," for "is required to be certified" and deleting "shall" and substituting "may." The intent of §195.3(d) is that before inspecting a clinic, the Board will complete a comprehensive evaluation of all eight of the criteria in §195.3(d), and if after this evaluation, the Board reasonably believes that a clinic has not been properly certified, the Board may choose to inspect such clinic.

The Board anticipates that the Prescription Monitoring Program (PMP) criteria in subsections (d)(3) and (d)(4) will play an integral part in every evaluation of the eight criteria identified. It needs to be emphasized that these criteria, all of which are objective in nature, are to be used only to identify those clinics which the Board reasonably believes, based on a review of objective criteria, should be certified under Chapter 168. These criteria provide notice of Board staff's evaluation process in carrying out the legislative intent. The results of the inspection process determines whether a clinic should be certified. The Board points out that the legislature, in charging the Board with establishing grounds or criteria for conducting an inspection, provided flexibility in establishing these criteria by utilizing the Board's expertise. Further, all eight of the criteria were based on board staff's collective experience gained from conducting investigations involving non-therapeutic prescribing and failing to certify as a pain management clinic, over the past six years. The specificity sought by many of the commenters on these rules simply does not reflect the legislature's intent to provide the Board the flexibility to establish accurate and objective criteria in order to maximize its resources and target only those clinics that most likely require certification inspection and possible certification under Chapter 168.

Texas Pain Society Comment:

The Texas Pain Society Comments that one of the eight criteria listed in subsection (d)(1) - (8) might not be sufficient to suspect that a pain management clinic should be certified and suggests amending this section of the rule to read "After reviewing all of the criteria as whole, with input from a physician expert reviewer, the board suspects that clinic or facility is required to be certified under §168.101 of the Act, the board shall inspect such clinic or facility." The Texas Pain Society also comments that the rules as written are vague and will not accomplish the goal of shutting down pill mills. The Texas Pain Society suggests that the rules not be adopted until an additional stakeholder meeting is held.

Board Comments: Please see the response to comment immediately above.

Section 195.3(d)(1):

TMA\TAFP Comment: The TMA\TAFP comments that subsection (d)(1) erroneously refers to the Texas Physician Monitoring Program rather than the correct reference to the Prescription Monitoring Program. The TMA\TAFP additionally comments that the threshold for multiple patients is too ambiguous and too low and that there are numerous innocuous reasons for which a patient might travel a long distance to see a physician. The TMA\TAFP suggest that a better threshold would be a "significant number of patients traveling from long distances." The TMA further comments that "geographic area of service" is ambiguous and ripe for abuse by the board. Finally, the TMA\TAFP comments that the criterion is not narrowly tailored to identify clinics required to be certified under Chapter 168 of the Medical Practice Act because it does not specifically reference patients travelling to receive prescriptions of opioids, benzodiazepines, barbiturates, or carisprodol. The TMA\TAFP comments do not recommend any specific language for amending subsection (d)(1).

Board Response: The Board incorporated the TMA\TAFPs comments by correcting an erroneous reference to the Texas Physician Monitoring Program and substituting language related to the Texas Prescription Monitoring Program (PMP).

The Board disagrees that the "geographical area of service" is ambiguous and ripe for "abuse" by the Board and adopts the proposed language of subsection (d)(5). The Board considered, in response to stakeholder input, using a defined number of miles to define geographic area, but decided that such a number of miles was not useful because areas of geographic service vary by region of the state. For example, patients driving 100 miles to see a provider in rural West Texas or other rural areas of Texas is not uncommon and does not raise red flags. However, patients from Houston, or Dallas, areas with abundant pain management resources available, travelling even 30 miles outside of the metro area could raise suspicion. The Board feels that using the current definition allows Board staff investigators to use the PMP and their training to determine if patients seem to be coming from outside the geographical area of service for a clinic. In the Board's previous investigations of clinics operating as pain clinics without certification, Board staff frequently saw patients traveling from outside the state to the clinics in question. The Board strongly disagrees that this criterion is "ripe for abuse." The Board's sole use of all of the eight criteria is to insure that the Board is able to efficiently direct its resources to identify and investigate/inspect under Chapter 168. The Board further points out this factor is only one of eight factors to be weighed in conjunction and a single factor would be insufficient to justify inspection.

Texas Pain Society Comment: The Texas Pain Society comments that the criteria in subsection (d)(1) needs to be more clearly defined to avoid inconsistent interpretations by board staff reviewing records. The Texas Pain society recommends amending the language of the order to read "he patient population of a clinic or facility includes a pattern\percentage of patients from outside the geographical area of service (100 miles) for which the clinic or facility provides service, are receiving prescriptions for controlled substances based on a review of the Texas Physician Monitoring Program (PMP) reports.

Board Response: See response above. While the Board did not accept the recommendation of geographical area of service of 100 miles, for the reasons described above, the Board will consider, at a future stakeholder meeting, language to include a pattern of patients outside of its geographical area of service being seen at a clinic. Additionally, Board staff is not able to determine how many patients a physician sees in one month until after an inspection/investigation has been completed.

Texas Orthopedic Association (TOA) Comment: The TOA comments that the rule raises a concern that orthopedic surgeons could be improperly flagged under this criterion because many such surgeons operate satellite clinics throughout the state while other orthopedic surgeons, for example orthopedic surgeons in San Antonio frequently have patients that travel to see them from all over South and West Texas.

TMB Response: The Board understands the concerns raised by the TOA but believes that members of the TOA as specialists treating patients within their area of specialty (surgery), and performing surgery are exempt from the application of Chapter 168 by §168.002(7). Additionally, prescriptions from opioids from orthopedic surgeons typically follow surgery and are of limited duration.

Section 195.3(d)(2):

TMA\TAFP Comment: The TMA\TAFP comments reflect a concern that this criterion's use of the term "several" patients living at the same address is ambiguous and may discourage physicians from treating a husband and wife for chronic pain. The TMA\TAFP comments that the criterion should be more narrowly tailored through additional stakeholder meetings.

Board Response:

The Board believes that "everal"is reasonably specific and requires at least two to three patients in a single household. The Board adopts the language of this rule as published. This criterion was based on the population of patients served by a clinic or facility, as directed by the legislature. Past Board investigations often found problem clinics non-therapeutically prescribing to multiple members of a household. The Board points out that this is only one of eight criteria to be used to be in determining if there is a reasonable belief that a clinic has not been properly certified as required by Chapter 168.

Texas Pain Society Comment: The Texas Pain Society comments that for several reasons it may be appropriate to prescribe to more than one patient from the same address. The Texas Pain Society recommends that the rule be amended to read "the patient population of the clinic or facility includes a pattern/percentage of patients at the same address who are all being treated for chronic pain with controlled substances."

Board Response: The Board agrees that in some situations it might be necessary and appropriate to prescribe to more than one patient as the same address. The Board declines to adopt the proposed language. The Board may consider a future amendment that incorporates a pattern of prescribing to patients at the same address depending on experience and information using the adopted criteria.

Section 195.3(d)(3):

TMA/TAFP Comment: The TMA comments favorably that the proposed rule may be an accurate indication of clinics that should be certified as pain management clinics. The TMA/TAFP comments that it a reason for concern that subsection (d)(3) does not consider patient population outside of considerations for cancer and hospice treatment and that this could raise concerns for some specialists, such as orthopedic surgeons who frequently prescribe opioids, benzodiazepine, barbiturates, or carisprodol to treat acute pain. The TMA/TAFP additionally comments that the rule erroneously refers to "egistered"rather than "certified" pain clinics. The TMA/TAFP further comments that the rule lacks guidance for repeat inspections.

Board Response: The Board incorporates TMA\TAFP's suggested amendment regarded correcting the erroneous term "egistered"and substitutes the term "certified." The Board also address the TMA\TAFP's concerns about the subsection (d)(3)'s lack of guidance for repeat inspections by adding language that limits inspections of the top 50 prescribers to prescribers who have not been subject to an inspection under §195.3(c) in the previous 12 months. The Board additionally added language clarifying that the top 50 criteria applies to a prescriber that was among the top 50 prescribing at any time in the previous twelve months. The Board disagrees that this criterion would capture orthopedic surgeons as such surgeons would be exempt from Chapter 168 under §168.002(7) as explained in the Board's response to comments to subsection (d)(1), above.

Texas Pain Society Comment: The Texas Pain Society comments favorably that they agree with the top 50 prescriber criteria. The Texas Pain Society further comments that they would like to see greater clarification as to what constitutes a top 50 prescriber, specifically, whether the top 50 criteria is linked to a specific drug, a class of drug, or combination of drugs. The Texas Pain Society also asks what time period(s) will govern the top 50 criteria, the year, the past six months, or the last week? Finally, the Texas Pain Society suggests that chronic prescriptions longer than three months should be used instead of acute prescriptions.

Board Response: The Board addresses the Texas Pain Society regarding the applicability of the time period applied to the top 50 criteria by inserting language that the criteria applies if prescriber was a top 50 prescriber at any time in the previous 12 months. The Board declines to adopt the Texas Pain Society's suggestion that "chronic" prescriptions longer than three months should be used instead of "acute" prescriptions as the distinction between such descriptions would not be immediately apparent based on a PMP snapshot and would necessitate checking the PMP entries for every patient to whom a physician prescribed for a three-month period or longer to determine if such prescriptions were for chronic or acute pain. Such research would be impractical and highly resource intensive.

Texas Orthopedic Association Comment: The Texas Orthopedic Association comments that the nature of orthopedic surgery requires orthopedic surgeons to control their patient's pain, which may require stronger pain medication to prevent unnecessary pain in surgical patients. The Texas Orthopedic Association further comments that orthopedic surgeons handle a high volume of patients which might result in orthopedic surgeons being identified as top 50 prescribers. The Texas Orthopedic Association finally comments that the board needs to address the vague nature of the top 50 criteria to confirm that orthopedic surgeons will not be flagged as top 50 prescribers.

Board Response: See Board Response to TOA comments in subsection (d)(1).

Adam Harris, MD Comments: Dr. Harris, an orthopedic surgeon expresses concerns that his practice, which specializes in knee reconstructions, and requires prescribing narcotics to patients for two to three months, might be classified as a pain management clinic under the rules. Mr. Harris states that an exemption for recent post-op patients is critical to differentiating pain clinics from busy surgical practices.

Board Response: See Board Response to TOA comments in subsection (d)(1).

Section 195.3(d)(4):

TMA\TAFP Comment: The TMA\TFP expresses concern regarding the scale of the criterion in subsection (d)(4) based on the term "multiple." TMA\TAFP suggests that as few as two patients could be considered to be "multiple" patients. TMA\TAFP suggests substituting "substantial" for multiple. TMA\TAFP suggests that this criterion should be further discussed at a stakeholder's meetings.

Board Response: The Board declines to incorporate the TMA\TAFP's recommendation to substitute "substantial" for "multiple" in regard to information that a physician or mid-level prescriber is prescribing a combination of opioids, benzodiazepines, barbiturates, or carisprodol to patients. The Board disagrees that Board staff would consider ""ultiple patients," as "few as two patients" receiving prescriptions for opioids in combination with benzodiazepines, barbiturates, or carisprodol, as suggested by the TMA\TAFP. The training and experience of board staff in identifying noncertified clinics operating as pain management clinics make it highly unlikely that Board staff would treat two patients, who are receiving the combination of drugs identified in subsection (d)(5), as "multiple" patients, and even if they did, using evidence of two patients receiving the specified combination of drugs, such finding would not, in isolation, contribute to a reasonable belief that a clinic should be certified under Chapter 168. The Board believes that the term "substantial" provides no greater guidance than "multiple" for the purposes of subsection (d)(4), as each determination is necessarily fact specific.

Texas Pain Society Comment: The Texas Pain Society agrees that the combination of drugs mentioned in subsection (d)(4) are dangerous and non-therapeutic, but asks for clarification whether the top 50 criteria would be based on the combination of drugs listed in subsection (d)(4). The Texas Pain Society states that if the top 50 criteria were based on the combination of drugs described in subsections (d)(4), the (d)(3) might be sufficient and (d)(4) unnecessary.

Board Response: The Board asserts that the criteria in subsections (d)(3)and (d)(4) are both important, and identify different concerns. In some situations, even if a physician is not in the top 50 prescribers in the State, the physicians prescribing the drug combination described in subsection (d)(4) and prescribing such to multiple patients might help identify, along with other criteria, whether there is a reasonable belief that the clinic should be registered under Chapter 168.

Texas Orthopedic Association (TOA) Comment: The TOA comments that expresses concern that the PMP may fail to recognize prescription drugs prescribed by another physician and improperly attribute the prescription to an orthopedic surgeon who was prescribing opioids only, resulting in such physician being identified as meeting the subsection (d)(4) criterion.

Board Response: Please see Board Response to TOA Comments in regard to subsection (d)(1), above.

Section 195.3(d)(5):

TMA\TAFP Comment: The TMA\TAFP expresses concern that subsection (d)(5) would authorize the board to rely on anonymous complaints regarding non-therapeutic prescribing practices, and that subsection (d)(5) contains no requirement that the information be trustworthy or have other indicia of reliability. The TMA\TAFP additionally comments that the rule as written would allow for a single incident to give rise to an inspection. Finally, the TMA\TAFP comments that the inappropriate prescribing practices referenced should be related to or limited to inappropriate prescribing practices related to opioids, benzodiazepines, barbiturates, or carisoprodol.

Board Response: Although the Board is already prohibited by statutes from accepting and investigating anonymous complaints, the Board has addressed the TMA\TAFP's concerns by inserting language that limits the complaints referenced in subsection (d)(5) to non-anonymous complaints. The Board disagrees with the TMA\TAFP that the legislature intended that the Board impose a requirement that complaints, on their face, provide indicia of reliability or trustworthiness. The legislature has made it clear that the purpose of an administrative investigation by the Board is to allow the gathering of information to determine whether violation(s)of the Medical Practice Act and board rules exist. Finally, the Board strongly disputes the TMA\TAFP's assertion that the rule, as written, would allow for a single incident to give rise to an inspection. Such an assertion is highly speculative, far-fetched, and not supported by the language of the rule. The rule refers to "inappropriate prescribing practices," with the word "practices" being plural. The rule would not allow for a single prescribing incident, in isolation, to give rise to an inspection. Nor would a complaint regarding inappropriate prescribing practices, in isolation and identified in subsection (d)(5), to justify an inspection, unless the content of that complaint, along with an evaluation of the other seven criteria contributed to a reasonable belief that a clinic should be certified under Chapter 168.

Texas Pain Society Comment: The Texas Pain Society agrees that other agencies may have information to help identify clinics that should be inspected. The Texas Pain Society asks for further clarification of the criterion, specifically: will the information be documented in a formal complaint, or would verbal information be sufficient; will the complaints be available to the clinic being inspected; how would the TMB vet the information before acting on it; would the TMB be required to verify the information.

Board Response: The Board declines to further modify the language of the rule. The Board is required to follow standard complaint and investigation/inspection processes and procedures. As to whether complaints would be provided to clinic being inspected, complaints are confidential by statute and SB 315 did not alter these confidentiality provisions.

Section 195.3(d)(6):

TMA\TAFP Comment: The TMA\TAFP comment that subsection (d)(6) raises concerns because overdose deaths of patients from controlled substances by a physician or mid-level provider are not tied specifically to opioids, benzodiazepines, barbiturates, or carisoprodol.

Board Response: The Board incorporates the TMA\TAFP's comments by adding language that links a patient overdose death to opioids, benzodiazepines, barbiturates, or carisoprodol prescribed by a physician or mid-level provider.

Texas Pain Society Comment: The Texas Pain Society agrees with the TMB that overdose deaths due to controlled substances raise a red flag. The Texas Pain Society asks for clarification of the rules regarding suicides, overdoses deaths caused by drugs from other prescribers, and overdoses caused by a combination of prescribed drugs and illicit substances.

Section 195.3(d)(7):

TMA\TAFP Comment: The TMA\TAFP expresses concerns that subsection (d)(7) does not specifically limit the arrest of a physician or mid-level provider related to improper or fraudulent prescribing of controlled substances to opioids, benzodiazepines, barbiturates, or carisoprodol.

Board Response: The Board declines to modify the language of subsection (d)(7) to specifically reference fraudulent prescribing of opioids, benzodiazepines, barbiturates, or carisoprodol, as information related to arrests for fraudulent or improper prescribing often does not specify the substances for which the fraudulent or improper prescribing occurred. Additionally, if law enforcement arrests a practitioner for fraudulent prescribing the Board has a duty to investigate. As part of any investigation of this nature the board will look at the totality of the circumstances and events, which will help determine the applicability of the provisions in Chapter 168.

Section 195.3(d)(8):

TMA\TAFP Comment: The TMA\TAFP agrees that the criterion in subsection (d)(8) relates to identifying clinics which are required to be certified under Chapter 168. The TMA\TAFP expresses concern that subsection (d)(8) does not indicate who is developing the information or assurances that the information has any amount of reliability.

Board Response: The Board declines to modify the rule according based on TMA\TAFP's comments points out that Board investigators are the individuals who develop information during an investigation. The reliability of information is determined through the investigative and disciplinary process. That is the purpose of an administrative investigation/inspection.

Texas Pain Society Comment: The Texas Pain Society expresses concern that the rule lacks clarity, might lead to unintended consequences, and might overlap with one of the other seven criteria.

Board Response: The Board disagrees that the rule lacks clarity. The rule requires that the nature of the information developed during an investigation indicates a physician or mid-level prescriber is prescribing, to a majority of its patients, opioids, benzodiazepines, barbiturates, or carisoprodol. Information developed during an investigation may take many forms and it would be highly impracticable to set out all conceivable types and sources of the information gathered or developed and delineate such in the form of a rule. The Texas Pain Society's concern that the rule will lead to unintended consequences is highly speculative and no examples are offered of such unintended consequences.

Section 195.3(e):

TMA\TAFP Comment: The TMA\TAFP comments that the five-day notice afforded to certified by certified pain management clinic should not be limited to certified pain management clinics and should be extended to non-certified pain management clinics that the board believes should be registered under Chapter 168. The TMA\TAFP additionally comments that withholding the five day-notice will increase administrative burdens on the clinics inspected.

Board Response: The Board declines to extend the five-day notice provision to non-certified pain management clinics. The Board points out that clinics already certified in compliance with Chapter 168 have demonstrated good faith in complying with the Medical Practice Act and Board rules related to Pain Management Clinics. Some of these clinics may have also successfully passed Board inspections in the last few years. Accordingly, these clinics are less likely to demonstrate issues related to possible falsification of patient sign-in sheets and patient records since these clinics have recognized their need to obtain certification under Chapter 168 and comply with the requirements for certified pain management clinics because they are aware of the requirements that must be met in order to maintain certification and avoid violations. Allowing non-certified clinics, the five-day notice may create an opportunity, for clinics who are purposefully evading certification requirements, to falsify records during the five-day notice period. The Board has seen recent examples of such attempted falsifications in the last few years. The Board maintains that the legislature's finding that "the inspections and investigations conducted by the Board, including the board's use of subpoenas for immediate production, inspection, and copying of medical and billing records are necessary to adequately regulate the prescribing of opioids," demonstrate the legislative intent that the Board is authorized to utilize subpoenas instanter in inspecting non-certified pain management clinics.

Texas Pain Society Comment: The Texas Pain Society Comments that the same notice afforded to certified pain clinics should be offered to clinics that have not certified as pain management clinics to reduce patient care disruption.

Board Response: See response immediately above.

Section 195.3(f):

TMA\TAFP Comments: The TMA\TAFP asks why instanter subpoenas should also not be used to the inspect certified pain clinics.

Board Response: The Board responds to the TMA\TAFP comments by pointing out that §195.3(e) authorizes inspections without notice of certified pain clinics if such notice would jeopardize an ongoing investigation and so already authorizes use of subpoenas instanter.

Section 195.3(h):

TMA\TAFP Comment: The TMA\TAFP comments that the term "suspects" is vague and subject to individual biases and that the standard is subjective.

Board Response: The Board disagrees that "suspects" is vague and subjective in nature. Rather suspicions of violations of the requirements of Chapter 168 would be based on a comprehensive evaluation by Board investigators with extensive training and experience in dealing with pain management clinics. The Board will consider the substitution of a "reasonably believes" for "suspects" after further consideration and discussion of the issue at a stakeholders meeting.

The amendments are adopted under the authority of the Texas Occupations Code Annotated, §153.001, which provides authority for the 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 amendments are also adopted under the authority of §168.052 of the Texas Occupations Code.

§195.3.Inspections.

(a) The board may conduct inspections to enforce these rules, including inspections of a pain management clinic and documents and records of a physician(s) and mid-level practitioner(s) practicing at such a clinic, as set out in subsections (b) and (c) of this section.

(b) The board may inspect a pain management clinic certified under this chapter, including the documents of a physician practicing at the clinic, to determine if the clinic is being operated in compliance with applicable laws and rules. If violations of the Medical Practice Act or board rules are found during an inspection, the board may bring an enforcement action for such violations. The board may utilize the services of another state or local agency, as needed, in carrying out inspections under this section.

(c) The board may inspect a clinic or facility that is not certified under this chapter, including the documents of a physician practicing at the clinic or facility, to determine whether the clinic or facility is required to be certified under §168.101 of the Medical Practice Act. After an inspection, the Board may bring a disciplinary action for failure to certify the clinic as required by Chapter 168 of the medical practice act and board rules. In addition, to certification violations, if any, the Board may bring a disciplinary action for any other violation of the Medical Practice Act or board rules found during the inspection.

(d) The following criteria will be reviewed and evaluated in determining whether an inspection of a clinic or facility pursuant to subsection (c) of this section should be conducted. If, after evaluation of the criteria described below, the board reasonably believes that a clinic or facility has not been properly certified under §168.101 of the Act, the board may inspect such clinic or facility.

(1) the patient population of a clinic or facility includes multiple patients from outside the geographical area of service for which the clinic or facility provides service, based on a review of the Texas Prescription Monitoring Program (PMP) reports;

(2) the patient population of the clinic or facility includes several patients at the same address who are all being treated for chronic pain;

(3) data from the PMP indicating that the volume of prescribing of a physician, or mid-level provider(s )supervised by the physician at a clinic or facility, who has not been subject to an inspection under subsection (c) in the previous 12 months, places them in the top 50 prescribers in the state at any time in the preceding 12 months for prescriptions of opioids, benzodiazepines, barbiturates, or carisoprodol, excluding prescribers at certified pain management clinics, clinics or facilities engaged in treating cancer patients, and certified hospice facilities;

(4) information from the PMP that a physician or mid-evel provider(s) supervised by the physician is prescribing to multiple patients, opioids in combination with one, or all of the following: benzodiazepines, barbiturates, or carisoprodol in a clinic or facility;

(5) complaints and/or information, from non-anonymous complainants related to inappropriate prescribing practices, including those from law enforcement agencies or health care regulators, regarding a clinic or facility, or a physician or midlevel provider(s) supervised by the physician, working at the clinic or facility;

(6) A patient overdose death related to controlled substances opioids, benzodiazepines, barbiturates, or carisoprodol, prescribed by a specific physician or a physician's mid-level provider(s);

(7) arrest of a physician or a mid-level provider related to improper or fraudulent prescribing of controlled substances;

(8) information developed during the course of a board investigation of a physician or a physician's mid-level provider indicating that the physician or mid-level provider is prescribing to a majority of patients opioids, benzodiazepines, barbiturates, or carisprodol in a clinic or facility.

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

(f) When inspecting clinics or facilities that are not certified, the board may utilize a subpoena instanter requiring immediate production, inspection and copying of medical and billing records. Board staff will consult with the board's medical director prior to utilizing a subpoena instanter. If immediate production is not made in compliance with the subpoena, the board, acting through the attorney general, may file suit to enforce the subpoena in a district court in Travis County.

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

(h) The board shall conduct inspections of pain management clinics certified under this chapter if the board suspects that the ownership or physician supervision is not in compliance with board rules.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on January 29, 2018.

TRD-201800366

Scott Freshour

Interim Executive Director

Texas Medical Board

Effective date: February 18, 2018

Proposal publication date: November 3, 2017

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


PART 11. TEXAS BOARD OF NURSING

CHAPTER 217. LICENSURE, PEER ASSISTANCE AND PRACTICE

22 TAC §217.9

Introduction. The Texas Board of Nursing (Board) adopts amendments to §217.9, concerning Inactive and Retired Status. The amendments are adopted without changes to the proposed text published in the December 1, 2017, issue of the Texas Register (42 TexReg 6670) and will not be republished.

Reasoned Justification. The amendments are adopted under the authority of the Occupations Code, §301.151, and related §301.261, and clarify that a nurse whose license is in "retired" status may not engage in the practice of nursing. While a volunteer retired nurse may practice nursing in compliance with the limitations of §217.9(e), a nurse whose license is in "retired" status may not. To the extent the current text of the subsection is unclear in this regard, the adopted amendments clarify this existing restriction.

How the Section Will Function. The current rule text provides that a nurse whose license is in "retired" status may not practice as a nurse for monetary or non-monetary benefits. The adopted amendments eliminate all reference to compensation because a retired nurse may not practice nursing at all. The current rule text may cause confusion and ambiguity regarding this existing restriction. As such, the adopted amendments clarify that a retired nurse many not practice nursing.

Summary of Comments and Agency Response. The Board did not receive any comments on the proposal.

Statutory Authority.

The amendments are adopted under the Occupations Code, §301.151, and related §301.261.

Section 301.151 addresses the Board's rulemaking authority. Section 301.151 authorizes the Board to adopt and enforce rules consistent with Chapter 301 and necessary to: (i) perform its duties and conduct proceedings before the Board; (ii) regulate the practice of professional nursing and vocational nursing; (iii) establish standards of professional conduct for license holders under Chapter 301; and (iv) determine whether an act constitutes the practice of professional nursing or vocational nursing.

Section 301.261(a) provides that the Board may place on inactive status the license of a person under Chapter 301 who is not actively engaged in the practice of professional nursing or vocational nursing if the person submits a written request to the Board in the form and manner determined by the Board. The inactive status begins on the expiration date of the person's license.

Section 301.261(b) provides that the Board shall maintain a list of each person whose license is on inactive status.

Section 301.261(c) provides that a person whose license is on inactive status may not perform any professional nursing or vocational nursing service or work.

Section 301.261(d) provides that the Board shall remove a person's license from inactive status if the person requests that the Board remove the person's license from inactive status; pays each appropriate fee; and meets the requirements determined by the Board.

Section 301.261(e) provides that the Board, by rule, shall permit a person whose license is on inactive status and who was in good standing with the Board on the date the license became inactive to use, as applicable, the title "Registered Nurse Retired," "R.N. Retired," "Licensed Vocational Nurse Retired," "Vocational Nurse Retired," "L.V.N. Retired," or "V.N. Retired" or another appropriate title approved by the Board.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on January 22, 2018.

TRD-201800221

Jena Abel

Deputy General Counsel

Texas Board of Nursing

Effective date: February 11, 2018

Proposal publication date: December 1, 2017

For further information, please call: (512) 305-6822


PART 16. TEXAS BOARD OF PHYSICAL THERAPY EXAMINERS

CHAPTER 322. PRACTICE

22 TAC §322.4

The Texas Board of Physical Therapy Examiners adopts amendments to §322.4, Practicing in a Manner Detrimental to the Public Health and Welfare, regarding the addition of a violation of the Physical Therapy Licensure Compact rules without changes to the proposed text as published in the December 8, 2017, issue of the Texas Register (42 TexReg 6891).

The amendments are adopted to include violating the Physical Therapy Licensure Compact rules as practicing in a manner detrimental to the public health and welfare with possible disciplinary action.

No comments were received regarding the proposed changes.

The amendments are adopted under the Physical Therapy Practice Act, Title 3, Subtitle H, Chapter 453, Occupations Code, which provides the Texas Board of Physical Therapy Examiners with the authority to adopt rules consistent with this Act to carry out its duties in administering this Act.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on January 26, 2018.

TRD-201800361

John P. Maline

Executive Director

Texas Board of Physical Therapy Examiners

Effective date: March 1, 2018

Proposal publication date: December 8, 2017

For further information, please call: (512) 305-6900


CHAPTER 323. POWERS AND DUTIES OF THE BOARD

22 TAC §323.5, §323.6

The Texas Board of Physical Therapy Examiners adopts new rules §323.5, Negotiated Rulemaking, and §323.6, Alternative Dispute Resolution, pursuant to Senate Bill (SB) 317 addition of §453.109, Occupations Code during the 85th Legislative Session without changes to the proposed text as published in the December 8, 2017, issue of the Texas Register (42 TexReg 6891).

The new rules are adopted in order to comply with statutory amendments to the Physical Therapy Practice Act regarding establishing a policy on Negotiated Rulemaking and Alternative Dispute Resolution.

No comments were received regarding the proposed new rules.

The new rules are adopted under the Physical Therapy Practice Act, Title 3, Subtitle H, Chapter 453, Occupations Code, which provides the Texas Board of Physical Therapy Examiners with the authority to adopt rules consistent with this Act to carry out its duties in administering this Act.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on January 26, 2018.

TRD-201800353

John P. Maline

Executive Director

Texas Board of Physical Therapy Examiners

Effective date: March 1, 2018

Proposal publication date: December 8, 2017

For further information, please call: (512) 305-6900


CHAPTER 325. ORGANIZATION OF THE BOARD

22 TAC §325.1

The Texas Board of Physical Therapy Examiners adopts amendments to §325.1, Elections, pursuant to Senate Bill (SB) 317 amendments of §453.058, Occupations Code, during the 85th Legislative Session with a non-substantive change to the proposed text as published in the December 8, 2017, issue of the Texas Register (42 TexReg 6892).

The amendments are adopted in order to comply with a statutory amendment to the Physical Therapy Practice Act regarding the designation of the presiding officer of the board by the governor.

No comments were received regarding the proposed changes.

The amendments are adopted under the Physical Therapy Practice Act, Title 3, Subtitle H, Chapter 453, Occupations Code, which provides the Texas Board of Physical Therapy Examiners with the authority to adopt rules consistent with this Act to carry out its duties in administering this Act.

§325.1.Elections.

(a) The governor shall designate a member of the board as the presiding officer of the board.

(b) Elections of officers shall be held at the second board meeting after new members are appointed.

(c) Officers will assume duties at the next board meeting following election.

(d) Vacancies of offices other than the presiding officer shall be filled by election at the next board meeting following the vacancy.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on January 26, 2018.

TRD-201800357

John P. Maline

Executive Director

Texas Board of Physical Therapy Examiners

Effective date: March 1, 2018

Proposal publication date: December 8, 2017

For further information, please call: (512) 305-6900


22 TAC §325.7

The Texas Board of Physical Therapy Examiners adopts an amendment to §325.7, Board Member Terms, pursuant to Senate Bill (SB) 317 amendments of §453.056(a) Occupations Code during the 85th Legislative Session. The amendment is adopted without changes to the proposed text as published in the December 8, 2017, issue of the Texas Register (42 TexReg 6893).

The amendment is adopted in order to comply with statutory amendments to the Physical Therapy Practice Act regarding grounds for removal and excused absences of a board member.

No comments were received regarding the proposed change.

The amendment is adopted under the Physical Therapy Practice Act, Title 3, Subtitle H, Chapter 453, Occupations Code, which provides the Texas Board of Physical Therapy Examiners with the authority to adopt rules consistent with this Act to carry out its duties in administering this Act.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on January 26, 2018.

TRD-201800356

John P. Maline

Executive Director

Texas Board of Physical Therapy Examiners

Effective date: March 1, 2018

Proposal publication date: December 8, 2017

For further information, please call: (512) 305-6900


CHAPTER 329. LICENSING PROCEDURE

22 TAC §329.2

The Texas Board of Physical Therapy Examiners adopts amendment to §329.2, Licensure by Examination, pursuant to Senate Bill (SB) 317 amendments of §453.205, Occupations Code, during the 85th Legislative Session without changes to the proposed text as published in the December 8, 2017, issue of the Texas Register (42 TexReg 6893).

The amendment is adopted in order to comply with a statutory amendment to the Physical Therapy Practice Act regarding the compliance of the security and copyright of the National Physical Therapy Examination and reporting of any known violations.

No comments were received regarding the proposed change.

The amendments are adopted under the Physical Therapy Practice Act, Title 3, Subtitle H, Chapter 453, Occupations Code, which provides the Texas Board of Physical Therapy Examiners with the authority to adopt rules consistent with this Act to carry out its duties in administering this Act.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on January 26, 2018.

TRD-201800363

John P. Maline

Executive Director

Texas Board of Physical Therapy Examiners

Effective date: March 1, 2018

Proposal publication date: December 8, 2017

For further information, please call: (512) 305-6900


CHAPTER 341. LICENSE RENEWAL

22 TAC §341.2

The Texas Board of Physical Therapy Examiners adopts amendment to §341.2, Continuing Competence Requirements, pursuant to Senate Bill (SB) 317 amendments of §453.254, Continuing Competence, Occupations Code, during the 85th Legislative Session without changes to the proposed text as published in the December 8, 2017, issue of the Texas Register (42 TexReg 6894).

The amendment is adopted in order to comply with a statutory amendment to the Physical Therapy Practice Act regarding the use of a Request for Proposal process in selecting an appropriate organization to approve continuing competence activities.

No comments were received regarding the proposed change.

The amendment is adopted under the Physical Therapy Practice Act, Title 3, Subtitle H, Chapter 453, Occupations Code, which provides the Texas Board of Physical Therapy Examiners with the authority to adopt rules consistent with this Act to carry out its duties in administering this Act.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on January 26, 2018.

TRD-201800364

John P. Maline

Executive Director

Texas Board of Physical Therapy Examiners

Effective date: March 1, 2018

Proposal publication date: December 8, 2017

For further information, please call: (512) 305-6900


CHAPTER 343. CONTESTED CASE PROCEDURE

22 TAC §343.35

The Texas Board of Physical Therapy Examiners adopts amendment to §343.35, Complaint Investigation and Disposition, pursuant to Senate Bill (SB) 317 amendments of §453.154(e), Occupations Code, during the 85th Legislative Session without changes to the proposed text as published in the December 8, 2017, issue of the Texas Register (42 TexReg 6895).

The amendment is adopted in order to comply with a statutory amendment to the Physical Therapy Practice Act regarding the designation of staff instead of the coordinator and the executive director to provide summary data of complaints to the board so that necessary action can be taken on the complaint.

No comments were received regarding the proposed change.

The amendment is adopted under the Physical Therapy Practice Act, Title 3, Subtitle H, Chapter 453, Occupations Code, which provides the Texas Board of Physical Therapy Examiners with the authority to adopt rules consistent with this Act to carry out its duties in administering this Act.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on January 26, 2018.

TRD-201800359

John P. Maline

Executive Director

Texas Board of Physical Therapy Examiners

Effective date: March 1, 2018

Proposal publication date: December 8, 2017

For further information, please call: (512) 305-6900