PART 9. TEXAS MEDICAL BOARD
CHAPTER 195. PAIN MANAGEMENT CLINICS
The Texas Medical Board (Board) adopts the repeal of §§195.1 - 195.4, without changes, they will not be republlished, and adopts new §§195.1 - 195.5, concerning Pain Management Clinics. New sections §§195.1 concerning Definitions, 195.2 concerning Gold Designated Practice, 195.3 concerning Certification of Pain Management Clinics, 195.4 concerning Minimum Operational Standards for the Treatment of Pain Patients, and 195.5 concerning Audits, Inspections, and Investigations are being adopted with non-substantive changes to the proposed text as published in the September 9, 2022, issue of the Texas Register (47 TexReg 5396). The adopted new rules §§195.1 - 195.5 will be republished.
Section 195.1. Definitions.
New Section 195.1, titled Definitions, provides definitions for three different types of pain: (1) acute, (2) chronic, and (3) post-surgical, post-procedure, persistent non-chronic pain, utilizing language consistent with definitions found in §170.2, for the same three categories of pain. The definitions are intended to clarify how the Board will determine which pain clinics are subject to the application of Chapter 168 of the Texas Occupations Code ("Medical Practice Act" or "Act").
Section 195.2. Gold Designated Practice.
New Section 195.2, titled Gold Designated Practice, creates a new designation of "Gold Designated Practice" available to certain practices that meet higher standards of education and practice. Under the proposed language, those higher practice standards include the utilization of multi-modal, multi-disciplinary approaches to the management of pain, through collaborative, coordinated care agreements, memorandums of understanding, or Medical Home Agreements with primary care physicians or pain management specialists, in addition to prescriptions for opioids or other controlled substances subject to Chapter 168 of the Medical Practice Act. Obtaining the Gold Designated Practice status will mean that a practice will not be the subject of a Board audit or inspection for five years from the date of obtaining the designation, subject to limited exceptions.
Subsection (a) outlines the proposed eligibility requirements for obtaining the Gold Designated Practice status.
Subsection (b) proposes that the designation may be verified by an initial audit and is valid for five years.
Subsection (c) provides that no further Board audits or inspections will be conducted during the five-year "Gold Designated Practice" period, unless a complaint is received or initiated by the board concerning the operation of the practice or operators at the practice, the clinic changes location, or the clinic's ownership structure changes to a majority of new owners.
Subsection (d) states that practices that only treat cancer-related pain, or that only provide palliative, hospice or other end-of-life care, are exempt under the Act from certification requirements as a PMC, but do not qualify for the "Gold Designated Practice" status.
The following non-substantive changes from what was proposed were adopted to this section in response to comments:
(1) the phrase "but not limited to" is added after the phrase "such as" to §195.2(a)(2), to clarify that the list of multimodal treatments and multi-disciplinary practices are not an exclusive list;
(2) the term "psychosocial" was changed to "biopsychosocial" under §195.2(a)(2)(C); and
(3) Medical Home Agreements must be signed by a primary prescriber rather than all providers, in addition to the patient being required to sign, under §195.2(a)(3)(A)(ii) and (3)(B)(i).
The section will be republished.
Section 195.3. Certification of Pain Management Clinics.
New Section 195.3, titled Certification of Pain Management Clinics, sets forth the procedures and requirements for pain clinics subject to the Act and requiring certification by the Board.
Subsection (a) sets forth language stating that any practice meeting the definition of a pain management clinic under Section 168.001 of the Act must be certified by the Board.
Subsection (b) language sets forth initial application procedures and requirements for certification by pain management clinics, addressing filing responsibilities for clinics owned by multiple physicians and documentation requirements.
Subsection (c) provides that review of the application is done by the Board's Executive Director (ED) and notice of the ED decision, including the right to appeal the decision, will be provided to the applicant.
Subsection (d) provides for renewal procedures and requirements for certified pain management clinics.
Subsection (e) states that if there is any investigation pending with the Board against any owner or certificate holder at the time of renewal, then a provisional renewal will be issued until the investigation is resolved. This section was reorganized from proposed subsection (d)(4) to subsection (e), which is a non-substantive change. Remaining sections (f) through (h) represent non-substantive re-lettering.
Subsection (f) provides that initial applications are valid for one year from the date filed, unless expressly extended by Board staff.
Subsection (g) states that all records relating to an application or renewal of a certificate are considered investigative information confidential and privileged under Section 164.007(c) of the Act.
Subsection (h) sets for requirements for certified pain clinics seeking to cancel certification.
Certain typographical errors were also corrected in this section, representing non-substantive changes from what was proposed. The sections will be republished.
Section 195.4. Minimum Operational Standards for the Treatment of Pain Patients.
New Section 195.4, titled Minimum Operational Standards for the Treatment of Pain Patients, sets forth language outlining the requirements for the treatment of pain patients by all practices treating pain, regardless of certification or other status. The rule also provides requirements for Gold Designated Practice physicians treating new pain patients who are transferring care from another pain provider.
Subsection (a) provides the minimum requirements for physicians treating pain patients, including standard of care, medical records, pain contracts, and monitoring requirements.
Subsection (b) sets forth requirements for Gold Designated Practice physicians treating new pain patients who are transferring care from another pain provider and provides that the new physician may provide only a one-time 30-day maximum non-refillable prescription for pain.
Non-substantive changes in response to comments were adopted to §195.4(b)(1)(C), so that a physician must request medical records from the prior treating physician(s) within 15 business days of seeing the patient, rather than being required to obtain the records within 15 days of seeing the patient.
Corresponding non-substantive changes were adopted to §195.4(b)(3), so that a physician must perform certain tasks prior to prescribing additional medications beyond the one-time prescription at the initial visit, if the requested medical records are not received within 15 business days of the date of request, rather than the date of the initial visit.
Further non-substantive changes were adopted to §195.4(b)(3)(B) in response to comments, adding the phrase "if applicable" to the requirement that diagnostic testing be ordered, and results obtained to verify pain sources or etiology. Section 195.4 will be republished.
Section 195.5. Audits, Inspections and Investigations.
New Section 195.5, titled Audits, Inspections, and Investigations, outlines processes for Board audits, inspections, and investigations conducted to determine compliance with laws and rules related to pain management clinics, including whether certification is required for pain clinics lacking certification. The rule outlines the grounds for inspections and possible outcomes.
For Board audits, the adopted language provides that the scope of review will cover a total of 30 patients records, with a combination of new patients seen in one of the last two calendar months and established patients seen in the previous six calendar months with a minimum of 10 records for each type. This represents a non-substantive change adopted in response to written comments received. The section will be republished.
For Board inspections, the rules' adopted scope will cover records on patients seen during two calendar months out of the previous eight months from the date of the inspection.
For Board investigations, the adopted rules indicate that they are complaint-generated and will be conducted in a manner consistent with board rules governing investigations.
The Board received eight comments regarding the proposed new rules to §§195.1 - 195.5. A summary of the comments relating to §§195.1 - 195.5, and the Board responses, are as follows:
(1) Texas Academy of Physician Assistants (TAPA)
Comment No. 1:
TAPA recommends a change to the definition of "post-surgical, post-procedure, persistent non-chronic pain" in §195.1. They recommend the definition read "chronic (or persistent) postoperative pain (CPOP) is a potentially devastating outcome from an otherwise successful surgical procedure. Patients experience pain (2-10% of the time of severe intensity) long after they have healed from the surgical insult."
Board Response:
The Board declines to make the recommended change to the definition of "post-surgical, post-procedure, persistent non-chronic pain." The definition proposed in §195.1 more clearly explains this type of pain. Therefore, the Board declines to make any changes in response to this comment.
Comment No. 2:
TAPA recommends the inclusion in §195.2 of Physician Assistants and Nurse Practitioners.
Board Response:
The Board declines to make the recommended changes, as this section deals with pain management clinics. These clinics must be operated by a physician or physicians with certain certifications or specialties, based on the definition of operator in §168.001 of the Act. Therefore, the Board declines to make any changes in response to this comment.
Comment No. 3:
In subsection (b) of §195.3, TAPA requests the addition of non-physician practice owners to the list of individuals who are permitted to complete the application paperwork. Additionally, TAPA requests the term "midlevel" in subsection (b)(2)(E) be replaced with "Physician Assistant and Nurse Practitioner," as they believe the term midlevel is vague and not defined in Texas code.
Board Response:
The Board does not agree that non-physician practice owners should be included in the list of those who are permitted to complete application paperwork. However, the Board does agree that the term "midlevel" should be replaced. Therefore, in response to this comment, the Board has made non-substantive changes to subsection (b)(2)(E) for consistency with subsection (b)(2)(D).
Comment No. 4:
TAPA suggests the number of CME hours for PAs in pain management clinics should be reduced in subsection (d) of §195.3, since the acts of a PA are delegated and supervised by a physician.
Board Response:
The proposed rule requires at least ten hours of CME related to pain management in the preceding two years. The Board believes this is an appropriate amount of CME and is not unreasonable or overly burdensome. Therefore, the Board declines to make any changes in response to this comment.
Comment No. 5:
In subsection (e) of §195.3, TAPA suggests a clinic should be allowed to cancel its certificate without reason. Additionally, TAPA suggests that if a clinic withdraws its certification, there should be a waiting period of at least two years before being able to reapply.
Board Response:
The Board disagrees and declines to make changes in response to this comment.
Comment No. 6:
TAPA suggests that §195.4(a) should include Physician Assistants and Nurse Practitioners in addition to Physicians, as PAs and NPs are also treating these patients.
Board Response:
Because the physician maintains ultimate responsibility over treatment of the patient, the Board declines to make changes in response to this comment.
Comment No. 7:
TAPA recommends that §195.4 include a timeline to send patient records to/from a Gold Designated Practice. For example, if a new practice has 15 days to request medical records and is only able to prescribe for 30 days, TAPA suggests the time limit to transmit patient records be within 15 calendar days.
Board Response:
The Board's non-substantive changes to §195.4(b)(1)(C) and (b)(3) address concerns about timing of a treating physician requesting medical records from a previous treating physician. If records are not provided by the previous treating physician, the new treating physician can continue treating the patient by complying with the requirements of subsection (b)(3). Therefore, the Board declines making any changes in response to this comment.
Comment No. 8:
TAPA points out that §195.5(b)(5)(B) lists "patient population analysis, including review of patients coming from outside the immediate geographic location of the clinic." (This comment erroneously listed "Subsection (2)E)" as the citation for this comment, but it appears the comment refers instead to subsection (b)(5)(B).) TAPA's position is that there is no current definition of "immediate geographic location," which makes the analysis subjective.
Board Response:
The Board intends to allow some flexibility in this area. Therefore, the Board declines to make any changes in response to this comment.
(2) Chronic Illness Advocacy & Awareness Group, Inc.
Comment No. 1:
Chronic Illness Advocacy & Awareness Group, Inc. asks that the term "medical home agreement," found in §195.2(a)(2), be defined.
Board Response: The Board declines to add a definition for "medical home agreement," as it is a commonly understood term in the medical community.
Comment No. 2:
Chronic Illness Advocacy & Awareness Group, Inc. expressed concern that §195.2(a) requires gold standard practice patients to be weaned from all pain medications and whether the patients could be fired for refusing certain multimodal treatment procedures, such as spinal injections.
Board Response:
The rules do not require chronic pain patients receiving treatment at gold standard practice settings to be weaned from all medications. The intent of the rules is to increase patient safety and access to legitimate chronic pain treatment and multi-modal approaches, in addition to the use of appropriate prescriptions for pain medication. Physicians who practice in gold standard practice settings will continue to have the discretion to prescribe appropriate prescriptions for pain medications as part of their treatment plans, as well as to utilize multi-modal and multidisciplinary treatment methods. The language under §195.2 is sufficiently clear as to this intent, and the Board declines to implement the requested changes.
Comment No. 3:
Chronic Illness Advocacy & Awareness Group, Inc. notes the use of the terms "tapering and weaning" under §195.2(a)(2)(B) and expressed concerns about the safety risks to patients presented by having pain medications stopped suddenly without tapering, or tapering pain medications too quickly. The commentor recommended that the rules address such practices.
Board Response:
The intent of the rules is to increase patient safety and access to legitimate chronic pain treatment and multi-modal approaches, in addition to the use of appropriate prescriptions for pain medication. Physicians are required to meet the standard of care in any tapering or weaning practices. The language under §195.2 is sufficiently clear and the Board declines to implement changes.
Comment No. 4:
Chronic Illness Advocacy & Awareness Group, Inc. requests a definition for the term "motivational interviewing" used under §195.2(c). The commentor suggests that the section include the term "biopsychosocial," rather than just "psychosocial," stating that "it gives the appearance that pain is being treated increasingly like a psych issue rather than a physical one."
Board Response:
The Board declines to add a definition for "motivational interviewing," as it is a commonly understood term in the medical community. The board agrees that "biopsychosocial" is an accurate term and adopts the rules with that non-substantive change.
Comment No. 5:
Chronic Illness Advocacy & Awareness Group, Inc. recommends that the rules require standardized pain agreements, noting that the terms of such agreements vary among physicians. The commentor further recommends that the rules adopt a patient bill of rights prohibiting the termination of patient care without providing for a "taper plan" or "bridge meds."
Board Response:
The Board declines to add language requiring standardized pain agreements or adopting a patient bill of rights. While pain agreements must establish and inform the patient of the physician's expectations that are necessary for patient compliance, and outline patient responsibilities if the treatment plan includes extended drug therapy, the rules permit some flexibility in the language and terms used. As stated under §195.4(a)(2), physicians who treat chronic pain are required to meet the standard of care, including when terminating patient care, which would require ensuring the patient has sufficient notice of the termination and continuity of care for an appropriate period prior to the termination being effective. The Board declines to add the suggested language.
Comment No. 6:
Chronic Illness Advocacy & Awareness Group, Inc. expressed concern that the rules had the goal of limiting the prescribing of pain medication, rather than to increase patient access to appropriate pain prescribing. The commentor‘s position is that the gold standard practice model and use of multi-modal treatments are better suited for patients who do not have severe and "long term" pain.
Board Response:
The intent of the rules is to increase patient safety and access to legitimate chronic pain treatment and multi-modal approaches, in addition to the use of appropriate prescriptions for pain medication. Physicians who practice in gold standard practice settings will continue to have the discretion to prescribe appropriate prescriptions for pain medications as part of their treatment plans. The language under §195.2 is sufficiently clear as to this intent and the Board declines to implement changes.
(3) Texas Pain Society (TPS)
Comment No. 1:
For §195.2(a)(2)(A) - (B), outlining certain practice standards that would qualify a practice for a Gold Designated Practice designation, TPS recommends adding the phrase "but not limited to" to clarify that the list of standards was not exclusive. TPS further recommends removing topical creams or patches, computer-based training pain coaching, massage, and exercise or movement from the list of recognized multimodal and multi-disciplinary treatment methods that would qualify a practice for the Gold Designated Practice designation, stating that such methods are "far too easy for a pill mill to abuse."
TPS further recommended that the American Board of Interventional Pain Physicians certification be included in the list of specialty board certification that would qualify a practice for Gold Designated Practice under §195.2(a)(3)(A) - (B).
Board Response:
The Board appreciates TPS's comment. The Board agrees with adding the phrase "but not limited to" for clarification and adopts the rules with the non-substantive change. The Board disagrees with removing the methods discussed by TPS. Such methods are important to providing innovative and effective ways for physicians and patients to manage pain and have been recognized by medical professionals and various entities, including the Health and Human Services Pain Management Best Practices Inter-Agency Task Force.
The Board declines to add ABIPP as a recognized subspecialty certification that would qualify a practice for a Gold Designation Practice status, as ABIPP has not traditionally been recognized under Texas law for the purposes of licensure eligibility or otherwise. The Board's recognition is for the limited purpose of permitting advertising of the specialty certification.
Comment 2:
For §195.4(a)(2), relating to the minimum operational standards for the treatment of pain patients would require following the standard of care, TPS recommends adding the phrase "as outlined in TMB rule 170", and deleting (a)(3), which sets forth certain documentation, pain contract, and monitoring requirements, opining that Chapter 170 sets forth the standard of care for the topic of treating pain and that a reference to the rule would be more efficient. TPS made the same recommendation for 195.4(b), stating that documentation and PMP check requirements should be replaced with a reference to adhering to the requirements under Chapter 170.
Board Response:
The Board disagrees that Chapter 170 outlines the standard of care for the treatment of pain. It is correct that Chapter 170 sets forth certain responsibilities on the part of the patient and physician with respect to pain management. Further, Chapter 170 will be under review in the future, and possibly combined with Chapter 195.
Therefore, the Board declines to adopt the recommended change.
Comment 3:
For §195.4(b)(1)(C), TPS recommends eliminating the requirement that new treating physicians for patients transferring their care to a Gold Designated Practice obtain medical records within 15 days of seeing the patient and change the rule so that such physicians are required to request such records within a 15-day time period. TPS opined that records may not always be available, due to circumstances outside of the patient and the new treating physician's control.
Board Response:
The Board agrees that the rule's proposed language requiring a physician to obtain such records does not account for reasonable circumstances in which it may not be possible to obtain those records and may inappropriately burden patients. Changing the term "obtain" to "request" will represent a non-substantive change. Therefore, the Board adopts the rule with the non-substantive amendment.
The Board also notes that non-substantive changes adopted §195.4(b)(1)(C) would require a change to §195.4(b)(3), so that the timeframe for receiving copies of prior treating records is tied to the date of request, and not date of initial visit, as originally proposed. Therefore, the Board adopts non-substantive changes to §195.4(b)(3), so that the triggering deadline requiring that certain steps be completed is tied to the date of request and not initial visit.
Comment 4:
TPS recommends deleting §195.4(b)(3), which outlines requirements that new treating physicians are required to take if the requested medical records are not received within business days after the initial visit, including diagnostic testing and drug testing, before any prescriptions are issued beyond a one-time 30-day maximum non-refillable prescription for pain medications. TPS states the position that diagnostic testing is not the standard of care, nor is it required in Chapter 170 of the board rules and may force physicians to order tests that are not covered by insurers. TPS notes that physicians regularly treat patients who do not have treatment records from previous providers, and documentation of an attempt to obtain such records should suffice.
Board Response:
The Board disagrees. The rule is designed to ensure that the new treating physician obtains all relevant information needed to formulate an accurate diagnosis and appropriate treatment plan before providing more prescriptions for pain medication.
However, the Board agrees that diagnostic testing should not be mandated in all cases. Whether diagnostic testing should be ordered will depend on the standard of care and the particular circumstances for each patient.
Therefore, the Board adopts the rule with an added non-substantive phrase "as applicable", with respect to the requirement for drug testing under §195.4(b)(3).
Comment 5:
For §195.5, TPS recommended providing clearer metrics on how patient records will be selected during an audit and defining more clearly how new and established patients are defined. TPS requested that the rule outline the parameters for staff's selection of records, to ensure consistency by staff. Finally, TPS recommended changing §195.5(a)(2)(C) so that a combined five patient records would be required, rather than 60 patient records, stating that the rules as currently proposed threaten to overly burden legitimate pain practices and waste TMB resources. TPS also recommended including in the audit records related to referrals, procedure notes, procedure logs, prior authorization notes, and consultation notes.
Further, TPS suggested placing Gold Designated Practices on a "fast track" process if subject to a complaint that would trigger an audit or investigation.
Board Response:
The Board disagrees that five patient records would provide sufficient information for the purposes of an audit but agrees that a lower number than 60 would be sufficient. The Board disagrees that Gold Designated Practices should be placed on a "fast-track" process if becoming the subject of a complaint that would trigger an audit or investigation, as the agency has limited resources and the current timelines for completing audits are sufficient.
The Board agrees, however, that the rules should provide clearer parameters with respect to what records will be requested during an audit, and agrees with TPS's suggestions to include referrals, procedure notes, procedure logs, consultation notes, and prior authorization documentation. The rules are adopted with a non-substantive change amending the proposed rule so that one specific set of records are outlined in §195.5(a)(3). The set of records obtained will require a total of 30 patients records, with a combination of new patients seen in one of the last two calendar months and established patients seen in the previous six calendar months with a minimum of 10 records for each type. This language reduces the proposed number of records, and mirrors proposed requirements for a combination of new and established patients seen in a specific time period, and therefore is a non-substantive change.
(4) Kriegel & Associates, Interdisciplinary Pain Management Specialists
Comment No. 1:
Kriegel & Associates, Interdisciplinary Pain Management Specialists expressed support for "building a quality assurance process into the field of pain treatment." He points out that The Commission for Accreditation of Rehabilitation Facilities (CARF) implemented accreditation standards in June 2022 that he believes are comprehensive and extremely rigorous.
Board Response:
The Board appreciates the rigorous accreditation standards established by CARF. However, the Board does not believe reliance on a private organization's standards would fulfill the regulatory role the Texas Legislature intended for the Board. Therefore, the Board declines to make any changes in response to this comment
(5) Commentor 1
Comment No. 1:
Commentor expressed support for the proposed rules. However, she pointed out that some patients may not have access to a Gold Designated clinic within driving distances, but one of the criteria for inspections (in §195.5(b)(5)(B)) includes a "review of patients coming from outside the immediate geographic location of the clinic." Ms. McGarity believes this criterion is concerning, given the number of patients who travel a great distance to find a specialist willing to accept them.
Board Response:
The Board understands this concern but does not intend to make patient travel distance in and of itself an indicator of fraud. The Board declines to make any changes in response to this comment
Comment No. 2:
Regarding §195.4(b)(2), the commentor expressed concern about the provision for a single 30-day continuing "bridge" prescription for a new patient. She suggests a longer time like 60 or 90 days to more realistically accommodate situations patients face, such as limited availability of appointments, travel distance required, and patients' work/family responsibilities.
Board Response:
The Board believes that 30 days is an adequate time period for this "bridge" period. This would also be consistent with other rules dealing with continuity of care. Therefore, the Board declines to make any changes in response to this comment.
Comment No. 3:
Commentor pointed out guidance published by the states of Washington and Minnesota that protect patients from unsafe tapering practices. She states that many entities incentivize tapering and discontinuation of opioid medication, while very few entities measure outcomes of tapering on patients' quality of life. She encourages the Board to publish additional guidance, similar to the language of Washington and Minnesota that hard maximum dosage limits and mandatory across-the-board taper policies are not a standard of care in Texas.
Board Response:
The Board recognizes the importance of patients' quality of life and does not intend to incentivize unsafe tapering practices or hard maximum dosage limits. However, the Board does not believe that this rule is the place to express such sentiments, so the Board declines to make any changes in response to this comment.
(6) Texas Medical Association (TMA)
Comment No. 1:
TMA opines that §195.1's definitional language inappropriately singles out opioid prescriptions, perpetuating the stigma that the prescription of opioids is a problem, and minimizing the importance of valid opioid prescriptions to treat pain. TMA further states that the proposed rule only uses opioid prescriptions as a criterion for potential inspection or certificate, even though Chapter 168 also includes prescriptions for benzodiazepines, barbiturates, and carisoprodol in determining certification requirements.
Board Response:
The Board disagrees that the definitional section inappropriately singles out opioid prescriptions. Pain management clinic certification requirements under Chapter 168 of the Texas Occupations Code were put into place to decrease overdose deaths, and opioid prescriptions are one of the primary drivers of overdose deaths. The Board declines to make requested changes to this section.
Comment 2:
TMA states support for the rule's proposed Gold Designated Practice status. TMA requests a broader application of §195.2's eligibility for Gold Designated status so that more exempt pain clinics would be able to obtain the status, so that clinics with a majority of physicians with specialty certification in an area of practice other than pain management be eligible for the status.
TMA states support for the rule's proposed Gold Designated Practice status.
TMA further opines that there is redundancy in §195.2(a)(3)(B)'s requirement that a certified pain management clinic operated by physicians who previously held or are eligible to hold certification in pain management consult with a pain specialist, and requests to eliminate that requirement.
Board Response:
The Board declines to make the requested changes. The Board disagrees that encouraging a specialty consult for physicians who do not currently hold specialty certification in pain management would be redundant. The Board disagrees that the rules providing for Gold Designation Practice status should be expanded to practices operated by a majority of physicians who hold specialty certification in an area other than pain management. The Gold Designation status represents the highest bar for clinics to achieve and specialty certification recognized should reflect physician specialization that will provide the most expertise and benefits to patients seeking treatment for pain management.
Comment 3:
TMA asserts that medical home agreements under §195.5(a)(3) should not require signatures by all treating providers. TMA requests that the proposed rule be amended so that medical home agreements require signature by patients only, or if providers as well, only prescribing providers. 195.2(a)(3) medical home agreements should not require signature of all providers. TMA asserts that it is the convention to only require patient signatures on such agreements. TMA also requests that other like agreements be recognized for the purpose of Gold Designation status.
Board Response:
The Board agrees with the recommendation that not all providers be required to sign the agreements. Therefore, the Board adopts the non-substantive change requiring only the primary prescriber to sign the agreement, in addition to the patient.
Comment 4:
TMA further requests that the Board consider expanding the Gold Designated Status to all exempt entities under Texas Occupations Code Section 168.002, including hospitals, including ER settings.
Board Response:
The Board declines to expand the status to all exempt entities such as hospitals, including ER settings. The pain medication provided in those settings are for acute and time-limited issues and are unlikely to involve ongoing care that will involve medical home agreements, collaborative care agreements, and multi-modal or multi-disciplinary treatments. The point of the Gold Designated Practice status is to recognize the highest bar being met with respect to the ongoing pain management treatment, and not simply to recognize that a setting is exempt from certification requirements.
Comment 5:
TMA recommends changing 195.2(a)(3)(A)(i) so that it refers to other forms of treatment "with the issuance of a prescription", rather than "besides qualifying pain management prescriptions to a majority of the patients at the clinic." TMA opines that the proposed language may unintentionally and inappropriately narrow who qualifies for gold designated status.
Board Response: The Board disagrees that the proposed language isn't clear and declines to adopt the requested changes.
Comment 6:
TMA recommends making several typographical and grammatical changes to §195.3:
Change "provide" to "providing the following documents" in subsection (b)(2);
Change "proof of ownership of the clinic that may include filings..." to "proof of ownership of the clinic, which may include filings..."in subsection (b)(2)(A);
Change "payment of the required filing fee" to "proof of payment of the required filing fee" in subsection (b)(2)(F);
In subsection (d), we recommend changing (d)(4) into a separate standalone subsection, either as (d-1) or (e).
Board Response: The Board agrees with the recommendations and adopts the rules with the non-substantive amendments making typographical and grammatical corrections. Further, the Board adopts the rules re-lettering subsection (d)(4) to subsection (e); and re-lettering remaining sections accordingly.
Comment 7:
TMA asserts that the §195.4's scope should be limited to chronic pain patients and not all pain patients. TMA states that position that imposing requirements such as random drug testing on acute pain patients would cause confusion and impose unnecessary requirements.
TMA also opposes requiring that pain contracts be made a part of the patient's medical record and requiring drug testing results and other forms of monitoring be made a part of the regular part of the patient's medical record, stating that such requirements are not mandated by statute and will unnecessarily add to physician's administrative burdens. Finally, TMA requests that language be added so that the 30-day prescription of medication permitted under §195.4(b)(2) be limited to prescriptions for one of the medications listed under Section 168.001(1) of the Texas Occupations Code.
Board Response:
The Board disagrees with the comment. The rules should apply to all providers who treat pain and the requirements outlined do not exceed that which is required. Pain contracts and different forms of treatment compliance monitoring are vital to a complete medical record. The limitation allowing only one prescription for 30-day maximum non-refillable prescription of pain medication at the initial visit should apply more broadly than just to the list of medications under Section 168.001(1) of the Texas Occupations Code. Therefore, the Board declines to adopt the requested changes.
Comment 8:
TMA requests that the rules be amended to provide clarification that exempt entities do not have to show more than what is necessary to demonstrate it is an exempt entity.
TMA further requests that for audits, that one method of record selection be used. One option that TMA suggests is looking at only new patients during a two-to-three-month calendar window to see whether a majority of patients received treatment other than pain medication; or alternatively, that a random sample of patients be selected, with a lookback to the initial encounter for each of those patients to determine if a majority of those patients received treatment other than just pain medication.
TMA also requests that the rules specify that the clinics will have the opportunity to provide documentation to dispute a finding made based upon records obtained in an audit.
For inspections, TMA requests that the rules include clarification that an inspection does not apply to an exempt entity and also requests that the records obtained be limited to either 1) a sample of new patients during the two to three calendar month window or 2) a sample of random patients in a two to three calendar month window with a lookback period to the initial encounter for those patients.
TMA also requests that the list of factors that will trigger an inspection be exclusive and not open-ended. TMA also disagrees with one factor, reports from the Pharmacy Board of multiple prescribing providers, which may trigger an inspection. TMA believes that such reports should trigger an audit instead of an inspection, to account for those circumstances in which the provider had no reason to discover the other providers through a PMP check or otherwise.
Finally, TMA asserts that law enforcement involvement at a pain clinic should not trigger an inspection, as currently proposed in the rules, unless it relates to pain management.
Board Response:
The Board agrees that the rules should provide clearer parameters with respect to what records will be requested during an audit. The rules are adopted with a non-substantive change amending the proposed rule so that one specific set of records are outlined in §195.5(a)(3). The set of records obtained will require a total of 30 patients records, with a combination of new patients seen in one of the last two calendar months and established patients seen in the previous six calendar months with a minimum of 10 records for each type. This language reduces the proposed number of records, and mirrors proposed requirements for a combination of new and established patients seen in a specific time period, and therefore is a non-substantive change.
The Board disagrees with TMA's remaining comments regarding §195.5, and declines to make the requested changes.
The rules outline clear requirements regarding the basis for an audit, which is to determine whether certification is required for a pain clinic under Chapter 168 of the Act, and that would not require showing more than what is necessary to demonstrate that a practice is an exempt entity. Clinics will have the opportunity to provide a response to a Board finding that certification is necessary, which may include further documentation.
For inspections, the Board declines to make the requested change limiting the type of records that may be obtained to one of the requested categories. Inspections involve a higher level of scrutiny, and the category proposed, patients seen during two calendar months out of the previous eight months from the date of the inspection, will provide an accurate understanding of whether certification is required. Further, the Board declines to adopt changes stating that exempt entities will not be inspected, as the point of an inspection is to determine compliance with Chapter 168 of the Act, which includes whether certification is required, or whether an entity is exempt.
The Board declines to provide an exclusive list of factors that will trigger an inspection. There may be additional relevant factors outside of the list provided for under the rules, and the Board should not be required to amend the rules each time discovering relevant information that isn't specifically accounted for under the rules, in order to conduct a needed inspection. That would waste public resources and hamper the Board's ability to protect the public's health and welfare.
The Board disagrees that reports from the Pharmacy Board of multiple prescribing providers should only trigger an audit and not an inspection. Reports of multiple prescribing providers is an important red flag that a physician may not be in compliance with the laws pertaining to prescribing controlled substances, including checking the Prescription Monitoring Database prior to prescribing certain controlled substances, as required under the Health and Safety Code.
Finally, the Board disagrees with TMA's position that the category of law enforcement reports received about providers or patients that may trigger an inspection is too broad and should be limited to reports related to pain management. Because certain reports about pain management providers or patients may lack clarity, adding that specific limiting phrase "related to pain management" may inappropriately limit the Board's ability to inspect a practice, thereby unduly weakening its ability to protect the public's health and welfare. The Board declines to make the requested change.
(7) Commentor 2
Comment No. 1:
Commentor 2 raised concern about ambiguity in §195.3 for d/b/a practices that consist of unique separate legal entities. He questions whether the d/b/a would be considered to be one practice owned by multiple physicians under the rule or whether they would be considered to be separate practices.
Board Response:
This comment poses a legal question beyond the scope of rulemaking. Therefore, the Board declines to make any changes in response to this comment.
Comment No. 2:
Commentor questions the meaning of "majority" in §195.1.
Board Response:
The Board believes the term "majority" is self-explanatory and has common meaning in §195.1. The Board declines to make any changes in response to this comment.
Comment No. 3:
Commentor 2 seeks clarification of the requirements in §195.2(a)(3)(B) that the certified pain management clinic be operated by physicians who previously held an ABMS or AOA Board-certification or sub-specialty in pain management or hold an ABMS or AOA Board-certification in an area that is eligible for a pain management subspecialty. For example, the American Board of Family Medicine offers a Certificate of Added Qualifications (CAQ) in Pain Medicine that became available to qualifying family physicians in 2003. The commentor raises the issue of whether this CAQ would meet the rule's requirement for eligibility for a pain management subspecialty.
Board Response:
The Board believes the term "Board- certification" is self-explanatory in §195.2. This comment poses a legal question beyond the scope of rulemaking. Therefore, the Board declines to make any changes in response to this comment.
Comment No. 4:
Regarding §195.4(b)(1), the commentor expressed concern about the requirement for a new treating physician at a Gold Designated Practice to document an initial problem-focused examination. He states that this examination is not necessary for all patients. For example, surgeons will refer patients to him to manage patient's perioperative pain, so he has traditionally used the surgeons' documentation of the problem and planned procedure as justification for why medications were needed. Additionally, for patients with cancer or sickle cell or osteogenesis imperfecta, the referral documentation that confirms the diagnosis is adequate to justify the need for chronic pain medications. He asks whether an initial problem-focused exam is truly universally indicated for every new patient that presents to a Gold Designated Practice.
Board Response:
The Board believes that the examination is warranted and thus declines to make any changes in response to this comment.
Comment No. 5:
Also regarding §195.4, the commentor points out that the requirement to obtain medical records from a prior treating physician within 15 days of seeing the patient can be challenging. He asks for clarification whether there is some level of effort that is acceptable in attempting to obtain medical records or whether there is a defined process for documenting non-compliance by the previous treating physician.
Board Response:
The Board agrees that the rule's proposed language requiring a physician to obtain medical records from a prior treating physician does not account for reasonable circumstances in which it may not be possible to obtain those records and may inappropriately burden patients. Therefore, the Board adopts the rule with the non-substantive amendment of changing the word "obtain" to "request."
The Board also notes that non-substantive changes adopted §195.4(b)(1)(C) would require a change to §195.4(b)(3), so that the timeframe for receiving copies of prior treating records is tied to the date of request, and not date of initial visit, as originally proposed. Therefore, the Board adopts non-substantive changes to §195.4(b)(3), so that the triggering deadline requiring that certain steps be completed is tied to the date of request and not initial visit.
Comment No. 6:
Finally, the commentor asks that consideration be given to changing renewal from 180 days to 60 days before expiration of a clinic's certificate. Additionally, he asks that initial applications be considered valid for three years instead of one year, due to the administrative burden and time for registered pain management clinics.
Board Response:
The Board disagrees with the suggested timelines. First, the 180 days referenced in §195.3(d) refers to the time after the expiration of the clinic's certificate, so it refers to a grace period after expiration. There is no timeline before the expiration of a clinic's certificate in which the clinic must renew. Additionally, the Board does not believe that it is prudent for applications be considered valid for three years, as information would be stale after a year and not reliable. Therefore, the Board declines to make any changes in response to this comment.
(8) Commentor 3
Comment No. 1:
Commentor 3 applauds the Board's efforts to build in quality assurance to the regulation of pain management clinics. He urges the Board to consider requiring adherence to CARF standards as part of the Gold Designated Practice status defined in the proposed rules.
Board Response:
The Board appreciates the rigorous accreditation standards established by CARF. However, the Board does not believe reliance on a private organization's standards would fulfill the regulatory role the Texas Legislature intended for the Board. Therefore, the Board declines to make any changes in response to this comment
Two individuals appeared to testify at the public hearing on October 14, 2022, regarding new §§195.1, 195.2, 195.3, 195.4, and 195.5.
The repeals are adopted under the authority of Texas Occupations Code §153.001, which provides authority for the Board to adopt rules necessary to administer and enforce the Medical Practice Act and to adopt rules necessary to regulate and license physicians. The repeals are also adopted pursuant to §168.051 of the Texas Occupations Code.
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 October 20, 2022.
TRD-202204151
Scott Freshour
General Counsel
Texas Medical Board
Effective date: November 9, 2022
Proposal publication date: September 9, 2022
For further information, please call: (512) 305-7016
The new sections are adopted under the authority of Texas Occupations Code §153.001, which provides authority for the Board to adopt rules necessary to administer and enforce the Medical Practice Act and to adopt rules necessary to regulate and license physicians. The new sections are also adopted pursuant to §168.051 of the Texas Occupations Code.
§195.1.Definitions.
Pain management clinics at which a majority of patients are treated for chronic pain are subject to Chapter 168 of the Act, unless otherwise exempted. In determining if the clinic is treating a majority of patients for chronic pain, one of the primary indicators is the prescribing of opioids. The Board will utilize the following definitions in making that determination:
(1) Acute pain--the normal, predicted, physiological response to a stimulus such as trauma, disease, and operative procedures. Acute pain is time limited to no later than 30 days from the date of the initial prescription for opioids during a period of treatment related to the acute condition or injury. Acute pain does not include, chronic pain, pain being treated as part of cancer care; pain being treated as part of hospice or other end-of-life care; pain being treated as part of palliative care; or post-surgical, post-procedure, or persistent non-chronic pain.
(2) Chronic pain--pain that is not relieved with acute, post-surgical, post-procedure, or persistent non-chronic pain treatment. This type of pain is associated with a chronic pathological process that causes continuous or intermittent pain for no less than 91 days from the date of the initial prescription for opioids. Medical practices treating this type of pain patient may be subject to Chapter 168 of the Act.
(3) Post-surgical, post-procedure, persistent non-chronic pain--pain that occurs due to trauma caused by the surgery or procedure; or an underlying condition, disease, or injury causing persistent non-chronic pain. These types of pain last 90 days or less, but more than 30 days, from the date of initial prescriptions for opioids during a period of treatment.
§195.2.Gold Designated Practice.
(a) A clinic may apply to be designated as a "Gold Designated Practice." In order to be eligible for a "Gold Designated Practice" status, a clinic must:
(1) a Board-approved application form;
(2) Provide a Medical Home Agreement, written collaborative, coordinated care agreement or memorandum of understanding to provide management and treatments of pain, that describes measures that it provides and may be used for reduction of pain such as, but not limited to:
(A) multimodal treatment such as surgery, injections, pain pumps, osteopathic manipulation, epidurals, trigger point injections, dry needling, and topical creams or patches;
(B) multi-disciplinary practices such as medication assisted tapering and weaning, computer-based training pain coaching, acupuncture, chiropractic, physical therapy, massage, and exercise/movement; or
(C) collaborative care or other behavioral health integration services such as evidenced-based cognitive behavioral therapy interventions for mental health and pain reduction, medication management and opioid weaning, patient-centered education, regular monitoring and assessments of clinical status using validated tools, assessment of treatment adherence, motivational interviewing, and a structured approach to improving the biopsychosocial aspects of pain management; and
(3) In addition to providing a Medical Home Agreement, written collaborative, coordinated care agreement or memorandum of understanding to provide management and treatments of pain described above, the clinic must either:
(A) Meet the standards for exemption under Section 168.002(7) of the Act, including the clinic is operated by a majority of physicians who currently hold or previously held ABMS or AOA Board-certification or subspecialty certification in pain management; and
(i) have a majority of physicians perform or properly supervise delegates in providing other forms of treatment besides qualifying pain management prescriptions to a majority of the patients at the clinic;
(ii) the clinic's providers utilize a Medical Home Agreement signed by the primary prescriber and the patient; or
(iii) have a written collaborative, coordinated care agreement or a memorandum of understanding with the patient's primary physician for treating and managing the patient; or
(B) Be a Certified Pain Management Clinic (PMC) that is operated by physicians who previously held an ABMS or AOA Board-certification or sub-specialty in pain management or hold a ABMS or AOA Board-certification in an area that is eligible for a pain management subspecialty; and
(i) have a Medical Home Agreement signed by the primary prescriber and the patient; or
(ii) a written collaborative, coordinated care agreement or memorandum of understanding providing that each physician who prescribes qualifying prescriptions will consult with a pain specialist for the patient.
(b) The designation may be verified by an initial audit and is valid for five years.
(c) No further audits or inspections will be conducted during the five-year "Gold Designated Practice" period, unless:
(1) A complaint is received or initiated by the Board concerning operation of the clinic or operators at the clinic;
(2) The clinic changes location; or
(3) The clinic's ownership structure changes to a majority of new owners.
(d) Practices that only treat pain patients as part of cancer care, or that provide only palliative care, hospice or other end-of-life care, are exempt under the Act from certification requirements as a PMC, but do not qualify for the "Gold Designated Practice" status.
§195.3.Certification of Pain Management Clinics.
(a) Any clinic meeting the definition of a pain management clinic under Section 168.001 of the Act must be certified.
(b) Certification requires:
(1) a Board approved application filed by a physician owner of the clinic. If there are multiple physician owners, the application must be filed by one of the majority of owners, or if there are no majority owners, then each physician owner is responsible for designating one physician owner to file an application.
(2) providing the following documentation:
(A) proof of ownership of the clinic, which may include filing with county clerks, the Comptroller and Secretary of State, as applicable;
(B) days and hours of operation;
(C) name of medical director;
(D) list of employees, including contract physicians and other healthcare providers, and their applicable education, qualifications, training and professional licenses;
(E) protocols and standing delegation orders issued by licensed physicians to healthcare providers; and
(F) proof of payment of the required filing fee.
(c) The Executive Director (ED) or the ED's designee reviews all applications. After reviewing the applications, the ED will send a notice of determination to the applicant which includes the ED's determination. If the application is denied, then the ED will provide the information regarding the right to appeal.
(d) Before 180 days after the expiration of the clinic's certificate, a clinic seeking renewal must submit:
(1) a Board approved application;
(2) documentation that establishes all providers at the clinic involved in any part of patient care have completed at least ten hours of continuing education related to pain management in the preceding two years; and
(3) the required renewal fees.
(e) if there is any investigation pending with the Board against any owner or certificate holder at the time of renewal, then a provisional renewal will be issued until the investigation is resolved.
(f) Initial applications are valid for one year from the date filed, unless expressly extended by Board staff.
(g) All records relating to an application or renewal of certification are considered investigative information and are confidential under §164.007 of the Act.
(h) A request to cancel a certificate must be accompanied by proof that the clinic no longer meets the definition of a pain management clinic under §168.001 of the Act.
§195.4.Minimum Operational Standards for the Treatment of Pain Patients.
(a) Physicians treating a pain patient must:
(1) Operate in compliance with provisions of all applicable federal and state laws;
(2) Follow the standard of care;
(3) Maintain complete, contemporaneous and legible medical records, in the manner as a non-pain patient, and include documentation of:
(A) monitoring efficacy, daily functionality, description of pain relief;
(B) mandatory PMP checks;
(C) pain contracts, if applicable;
(D) support for billing; and
(E) drug testing results and other forms of monitoring for patient compliance with treatment recommendations.
(b) For pain patients transferring their care to a new treating physician at a Gold Designated Practice, the following applies:
(1) The new treating physician must:
(A) document an initial problem focused exam;
(B) document a PMP check; and
(C) request medical records from the prior treating physician(s) within 15 business days of seeing the patient.
(2) The new physician may provide only a one-time 30-day maximum non-refillable prescription of pain medication at the initial visit.
(3) If the requested medical records are not received within 15 business days after the initial request, the physician must perform the following before issuing any other prescriptions for pain treatment to the patient:
(A) a complete history and physical, including assessment of abuse or diversion potential;
(B) diagnostic testing and obtain the results to verify pain sources or etiology, if applicable;
(C) drug testing; and
(D) a PMP check.
§195.5.Audits, Inspections and Investigations.
(a) Audits.
(1) Audits are non-disciplinary reviews:
(A) conducted as an off-site document review; and
(B) initiated by a Board subpoena request for documents as necessary to determine or verify:
(i) exemption from application of Chapter 168 of the Act;
(ii) need to certify as a PMC; or
(iii) no certification requirement.
(2) A total of 30 patients records will be reviewed during an audit. The relevant portions of the 30 records to be reviewed are the initial visit; last two office visits; referrals; procedures notes/logs; consultation requests; consult notes, and prior authorization records, if any. These records will be a combination of new patients seen in one of the last two calendar months and established patients seen in the previous six calendar months with a minimum of 10 records for each type.
(3) Documents requested may also include those used to verify personnel training, qualifications, and general compliance with Chapter 168 of the Act and related rules.
(4) Upon completion of the audit, the Board will issue a notice of determination to the audited clinic owner. The notice of determination will specify:
(A) Deficiencies, if any; and
(B) If necessary, any corrective actions the clinic must take, including a requirement to apply for certification.
(b) Inspections.
(1) Inspections are non-disciplinary reviews:
(A) done on both certified and non-certified clinics in accordance with Section 168.052 of the Act; and
(B) usually conducted on-site but may also be off-site, as determined by Board staff.
(2) The following patient records will be reviewed during an inspection, as determined by Board staff: patients seen during two calendar months out of the previous eight months from the date of the inspection.
(3) For certified pain management clinics, inspections are conducted to verify compliance with Chapter 168 of the Act and the applicable laws and rules.
(4) For non-certified clinics, inspections are conducted to determine if the clinic is subject to be certified under Chapter 168 of the Act.
(5) In accordance with Section 168.052(b) of the Act, to initiate an inspection the Board has determined the following grounds can be utilized, but are not limited to:
(A) PMP reports;
(B) patient population analysis, including review of patients coming from outside the immediate geographic location of the clinic;
(C) common addresses for multiple patients;
(D) notices to providers from the Pharmacy Board regarding a patient having multiple prescribing providers;
(E) complaints about the clinic and its operation; and
(F) law enforcement reports regarding providers or patients.
(6) Notice of intent to inspect will be provided at least five days in advance unless such timing would compromise the inspection.
(7) Notice of inspection results will be provided in writing to the clinic.
(8) If the inspection determines instances of non-compliance, the Board will determine appropriate action to obtain compliance.
(c) Investigations may be conducted due to a complaint received or initiated by the Board. An investigation will be conducted in accordance with the provisions of this Title and all applicable 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 October 20, 2022.
TRD-202204152
Scott Freshour
General Counsel
Texas Medical Board
Effective date: November 9, 2022
Proposal publication date: September 9, 2022
For further information, please call: (512) 305-7016