Adopted Rules Title 28

TITLE 28. INSURANCE

PART 2. TEXAS DEPARTMENT OF INSURANCE, DIVISION OF WORKERS' COMPENSATION

CHAPTER 134. BENEFITS--GUIDELINES FOR MEDICAL SERVICES, CHARGES, AND PAYMENTS

The Texas Department of Insurance, Division of Workers' Compensation (DWC) adopts the following changes to 28 TAC Chapter 134, Subchapter F, concerning pharmaceutical benefits: repeal 28 TAC §§134.506 and 134.510, and amend 28 TAC §§134.500, 134.501, 134.502, 134.503, 134.504, 134.520, 134.530, 134.540, and 134.550. Subchapter F implements Texas Labor Code §§408.028 and 413.011, and Texas Insurance Code Chapter 1305. The DWC medical advisor recommended the amendments to the commissioner of workers' compensation under Labor Code §413.0511(b).

The amendments to §§134.500, 134.501, 134.502, 134.503, and 134.520 and the repeals of 134.506 and 134.510 are adopted without changes to the proposed text published in the August 23, 2024, issue of the Texas Register (49 TexReg 6397). These sections will not be republished.

The amendments to §§134.504, 134.530, 134.540, and 134.550 are adopted with changes to the proposed text published in the August 23, 2024, issue of the Texas Register (49 TexReg 6397). DWC reverted to existing text in parts of §§134.504, 134.530, 134.540, and 134.550 in response to comments to avoid unintended consequences. Sections 134.504, 134.530, 134.540, and 134.550 will be republished.

REASONED JUSTIFICATION. The changes update and reorganize Subchapter F. Repealing §§134.506 and 134.510, and amending §§134.500, 134.501, 134.502, 134.503, 134.504, 134.520, 134.530, 134.540, and 134.550 is necessary to remove obsolete provisions and to update references and language to be consistent with other rules. Labor Code §408.028 requires the commissioner by rule to adopt a closed formulary under §413.011, as well as a fee schedule, and provides requirements for prescribing prescription drugs, generic pharmaceutical medications, and over-the-counter alternatives. Insurance Code Chapter 1305 authorizes the establishment of workers' compensation health care networks for providing workers' compensation medical benefits and provides standards for the certification, administration, evaluation, and enforcement of their delivery of health care services to injured employees. The changes also include nonsubstantive editorial and formatting changes that make updates for plain language and agency style to improve the rule's clarity.

Section 134.500. The changes delete the definition of "open formulary." The Texas workers' compensation system now uses a closed formulary, so the reference to an open formulary is unnecessary. The changes correct a reference to the injured employee's Social Security number to specify only the last four digits of the number. The changes also renumber the paragraphs where needed and make editorial and formatting updates for plain language and agency style. Amending §134.500 is necessary to enhance the rule's clarity and accuracy.

Section 134.501. The changes correct obsolete references and make editorial and formatting updates for plain language and agency style. Amending §134.501 is necessary to enhance the rule's clarity and accuracy.

Section 134.502. The changes make editorial and formatting updates for plain language and agency style. Amending §134.502 is necessary to enhance the rule's clarity.

Section 134.503. The changes make editorial and formatting updates for plain language and agency style. Amending §134.503 is necessary to enhance the rule's clarity.

Section 134.504. The changes correct obsolete references and make editorial and formatting updates for plain language and agency style. In response to a comment, DWC removed a proposed change that would have required only the last four digits of the claimant's Social Security number, and retained the existing requirement for the full number. Amending §134.504 is necessary to enhance the rule's clarity and accuracy.

Section 134.506. Section 134.506 is repealed because it is an obsolete transitional provision. Repealing §134.506 is necessary to ensure that the published rules are current.

Section 134.510. Section 134.510 is repealed because it is an obsolete transitional provision. Repealing §134.510 is necessary to ensure that the published rules are current.

Section 134.520. The changes update the section title to remove an unnecessary reference to the 2011 transition to a closed formulary, add the sentence, "The closed formulary applies to all drugs that are prescribed and dispensed for outpatient use," to be consistent with §§134.530 and 134.540, and make editorial and formatting updates for plain language and agency style. Amending §134.520 is necessary to enhance the rule's clarity and accuracy.

Section 134.530. The changes remove unnecessary references, correct obsolete references, and make editorial and formatting updates for plain language and agency style. Amending §134.530 is necessary to enhance the rule's clarity and accuracy. In response to a comment, DWC removed a proposed change that would have specified the prescribing doctor or pharmacy as the requester for a medical interlocutory order.

Section 134.540. The changes remove unnecessary references, correct obsolete references, and make editorial and formatting updates for plain language and agency style. Amending §134.540 is necessary to enhance the rule's clarity and accuracy. In response to a comment, DWC removed a proposed change that would have specified the prescribing doctor or pharmacy as the requester for a medical interlocutory order.

Section 134.550. The changes correct obsolete references, update DWC's website address, clarify text, and make editorial and formatting updates for plain language and agency style. Amending §134.550 is necessary to enhance the rule's clarity and accuracy. DWC removed a proposed change that would have specified the prescribing doctor or pharmacy as the requester for a medical interlocutory order. In response to a comment, DWC also removed proposed changes to §134.550(h) to avoid unintentional conflicts in the timeframes for reconsideration of a preauthorization denial, and reverted to the existing text of that subsection with minor nonsubstantive edits.

SUMMARY OF COMMENTS AND AGENCY RESPONSE.

Commenters: DWC received two written comments and no oral comments. The Office of Injured Employee Counsel commented in support of the proposal. Texas Mutual Insurance Company (Texas Mutual) commented in support of the proposal with changes. There were no commenters against the proposal.

Comment on Subchapter F. The Office of Injured Employee Counsel stated that they supported DWC's proposed changes to remove obsolete provisions and to update references and language to be consistent with other rules.

Agency Response to Comment on Subchapter F. DWC appreciates the comment.

Comment on §134.501. Texas Mutual suggested that DWC consider revising §134.501(a)(4) to recognize that reimbursement may be made based on DWC pharmacy fee guidelines or at a contract rate authorized by Labor Code §408.0281.

Agency Response to Comment on §134.501. DWC appreciates the comment but declines to make the change. The lack of medical fee disputes involving that fee guideline indicates that the existing language in §134.501(a)(4) is sufficient, and DWC did not propose substantive changes to it. In addition, §134.503(f) already allows the insurance carrier to reimburse prescription medications or services at a contract rate that is inconsistent with the fee guideline as long as the contract complies with the provisions of Labor Code §408.0281 and applicable DWC rules.

Comment on §134.504. Texas Mutual recommended that DWC not adopt the proposed change to §134.504(a)(1)(A) that reduced the Social Security number reporting requirement to only the last four digits because the change would create difficulties for insurance carriers in complying with their medical EDI data reporting requirements under 28 TAC Chapter 134, Subchapter I, which requires the full Social Security number.

Agency Response to Comment on §134.504. DWC appreciates the comment and has removed the proposed change. The existing requirement for the full Social Security number remains.

Comment on §134.510. Texas Mutual stated that they supported the repeal of §134.510 but suggested that DWC consider whether repealing the provisions allowing agreements under subsections (c) and (d) could be problematic if any claims remain with an evergreen pharmacy agreement in place.

Agency Response to Comment on §134.510. DWC appreciates the comment but has proceeded with the repeal. The repeal is not retroactive, so existing agreements for long-ago claims should not be affected. Removing the obsolete provisions is necessary to ensure that the rules are current and accurate.

Comment on §§134.530 and 134.540. Texas Mutual recommended that DWC keep the existing language in §§134.530(e)(4) and 134.540(e)(4) intact to ensure that there are no unintended consequences limiting the request of medical interlocutory orders under §§133.306 or 134.550.

Agency Response to Comment on §§134.530 and 134.540. DWC appreciates the comment and has removed the proposed change. The existing requirements, which do not mention the prescribing doctor or pharmacy, remain.

Comment on §134.550. Texas Mutual recommended that DWC keep the language in current §134.550(h) intact to avoid unintentional conflicts in the timeframes for reconsideration of a preauthorization denial in §§134.600(o) and 19.2011(a)(1) and (9). Texas Mutual also recommended that DWC continue to use the acronym "MIO" to distinguish pharmacy medical interlocutory orders to address potential emergency situations from other types of medical interlocutory orders.

Agency Response to Comment on §134.550. DWC appreciates the comment and has removed the proposed change to §134.550(h), reverting to the existing text in that subsection. DWC declines to revert to the "MIO" acronym in the rule text, as "MIO" stands for "medical interlocutory order," and is clearer to read. There should be no confusion and no substantive change in simply spelling out an acronym to make the rule more accessible to readers. Differentiating types of medical interlocutory orders should be simple, as the requests and orders include their type. For example, a request for a medical interlocutory order under §134.550 states that it is being made under that section.

SUBCHAPTER F. PHARMACEUTICAL BENEFITS

28 TAC §§134.500 - 134.504, 134.520, 134.530, 134.540, 134.550

STATUTORY AUTHORITY. The commissioner of workers' compensation adopts amendments to §§134.500, 134.501, 134.502, 134.503, 134.504, 134.520, 134.530, 134.540, and 134.550 under Labor Code §§408.028, 408.0281, 413.011, 413.0141, 413.0511, 402.00111, 402.00116, and 402.061, and Insurance Code Chapter 1305, including §§1305.003, 1305.101, and 1305.153.

Labor Code §408.028 governs pharmaceutical services. It requires the commissioner by rule to adopt a closed formulary under §413.011, and provides requirements for prescribing prescription drugs, generic pharmaceutical medications, and over-the-counter alternatives. It requires the commissioner by rule to allow an employee to buy over-the-counter alternatives to prescribed or ordered medications, and to get reimbursement from the insurance carrier for those medications. It also requires the commissioner by rule to allow an employee to buy a brand-name drug instead of a generic pharmaceutical medication or over-the-counter alternative to a prescription medication if a health care provider prescribes a generic pharmaceutical medication or an over-the-counter alternative to a prescription medication. Section 408.028(f) requires the commissioner by rule to adopt a fee schedule for pharmacy and pharmaceutical services that will: (1) provide reimbursement rates that are fair and reasonable; (2) assure adequate access to medications and services for injured workers; (3) minimize costs to employees and insurance carriers; and (4) take into consideration the increased security of payment that Labor Code Title 5, Subtitle A, affords.

Labor Code §408.0281 provides requirements for the reimbursement of pharmaceutical services.

Labor Code §413.011 requires the commissioner to adopt health care reimbursement policies and guidelines that reflect the standardized reimbursement structures found in other health care delivery systems with minimal modifications to those reimbursement methodologies as necessary to meet occupational injury requirements. To achieve standardization, it requires the commissioner to adopt the most current reimbursement methodologies, models, and values or weights used by the federal Centers for Medicare and Medicaid Services, including applicable payment policies relating to coding, billing, and reporting. It also requires the commissioner to develop one or more conversion factors or other payment adjustment factors, taking into account economic indicators and the requirements of §413.011(d), which requires that fee guidelines be fair and reasonable, and designed to ensure the quality of medical care and to achieve effective medical cost control. It requires the commissioner to consider the increased security of payment that Labor Code, Title 5, Subtitle A, provides in establishing the fee guidelines.

Labor Code §413.0141 allows the commissioner by rule to require an insurance carrier to pay for specified pharmaceutical services sufficient for the first seven days following the date of injury if the health care provider requests and receives verification of insurance coverage and a verbal confirmation of an injury from the employer or from the insurance carrier as provided by §413.014. The rules must provide that an insurance carrier is eligible for reimbursement for pharmaceuticals paid under §413.0141 from the subsequent injury fund if the injury is determined not to be compensable.

Labor Code §413.0511 requires DWC to employ or contract with a medical advisor. The medical advisor must be a doctor, as defined in §401.011. The medical advisor's duties include making recommendations about the adoption of rules and policies to: develop, maintain, and review guidelines as provided by §413.011, including rules about impairment ratings; reviewing compliance with those guidelines; regulating or performing other acts related to medical benefits as required by the commissioner; and determining minimal modifications to the reimbursement methodology and model used by the Medicare system as needed to meet occupational injury requirements.

Labor Code §402.00111 provides that the commissioner of workers' compensation shall exercise all executive authority, including rulemaking authority under Title 5 of the Labor Code.

Labor Code §402.00116 provides that the commissioner of workers' compensation shall administer and enforce this title, other workers' compensation laws of this state, and other laws granting jurisdiction to or applicable to DWC or the commissioner.

Labor Code §402.061 provides that the commissioner of workers' compensation shall adopt rules as necessary to implement and enforce the Texas Workers' Compensation Act.

Insurance Code Chapter 1305 authorizes the establishment of workers' compensation health care networks for providing workers' compensation medical benefits and provides standards for the certification, administration, evaluation, and enforcement of their delivery of health care services to injured employees.

Insurance Code §1305.003(b) provides that Chapter 1305 controls if there is a conflict between Title 5, Labor Code, and Chapter 1305 as to the provision of medical benefits for inured employees, the establishment and regulation of fees for medical treatments and services, the time frames for payment of medical bills, the operation and regulation of workers' compensation health care networks, the regulation of health care providers who contract with those networks, or the resolution of disputes regarding medical benefits provided through those networks.

Insurance Code §1305.101(c) requires in part that prescription medication and services be reimbursed as provided by Labor Code §408.0281, other provisions of Title 5, Labor Code, and applicable rules of the commissioner of workers' compensation.

Insurance Code §1305.153 governs provider reimbursement. Subsection (a) states that the amount of reimbursement for services provided by a network provider is determined by the contract between the network and the provider or group of providers. Subsection (c) requires that out-of-network providers who provide care as described by §1305.006 be reimbursed as provided by Title 5, Labor Code, and applicable rules of the commissioner of workers' compensation. Subsection (d) subjects billing by, and reimbursement to, contracted and out-of-network providers to Title 5, Labor Code, and applicable rules of the commissioner of workers' compensation, as consistent with Chapter 1305. But applying those rules may not negate reimbursement amounts negotiated by the network.

§134.504.Pharmaceutical Expenses Incurred by the Injured Employee.

(a) If an injured employee needs to purchase prescription drugs or over-the-counter alternatives to prescription drugs prescribed or ordered by the treating doctor or referral health care provider, the injured employee may request reimbursement from the insurance carrier as follows:

(1) The injured employee must submit to the insurance carrier a letter requesting reimbursement along with a receipt indicating the amount paid and documentation concerning the prescription.

(A) The letter should include information to clearly identify the claimant such as the claimant's name, address, date of injury, and Social Security number.

(B) Documentation for prescription drugs submitted with the letter from the employee must include the prescribing health care provider's name, the date the prescription was filled, the name of the drug, employee's name, and dollar amount paid by the employee. As examples, this information may be on an information sheet provided by the pharmacy, or the employee can ask the pharmacist for a printout of work-related prescriptions for a particular time period. Cash register receipts alone are not acceptable.

(2) The insurance carrier must pay the injured employee under §134.503 of this title (Pharmacy Fee Guideline), or notify the injured employee of a reduction or denial of the payment within 45 days of receiving the request for reimbursement from the injured employee.

(A) If the insurance carrier does not reimburse the full amount requested or denies payment, the insurance carrier must include a full and complete explanation of the reasons the insurance carrier reduced or denied the payment and must inform the injured employee of his or her right to request medical dispute resolution under §133.305 of this title (MDR--General).

(B) The statement must include sufficient claim-specific substantive information to enable the employee to understand the insurance carrier's position or action on the claim. A general statement that simply states the insurance carrier's position with a phrase such as, "not entitled to reimbursement" or a similar phrase with no further description of the factual basis does not satisfy the requirements of this section.

(b) An injured employee may choose to receive a brand-name drug rather than a generic drug or over-the-counter alternative to a prescription medication that is prescribed by a health care provider. In such instances, the injured employee must pay the difference in cost between the generic drug and the brand-name drug. The transaction between the employee and the pharmacist is considered final and is not subject to medical dispute resolution by the division. In addition, the employee is not entitled to reimbursement from the insurance carrier for the difference in cost between generic and brand-name drugs.

(1) The injured employee must notify the pharmacist of their choice to pay the cost difference between the generic and brand-name drugs. An employee's payment of the cost difference is an acceptance of the responsibility for the cost difference and an agreement not to seek reimbursement from the insurance carrier for the cost difference.

(2) The pharmacist must:

(A) determine the costs of both the brand-name and generic drugs under §134.503 of this title, and notify the injured employee of the cost difference amount;

(B) collect the cost difference amount from the injured employee in a form and manner that is acceptable to both parties;

(D) not bill the injured employee for the cost of the generic drug if the insurance carrier reduces or denies the bill.

(3) The insurance carrier must review and process the bill from the pharmacist under Chapters 133 and 134 (General Medical Provisions and Benefits--Guidelines for Medical Services, Charges, and Payments, respectively).

§134.530.Closed Formulary for Claims Not Subject to Certified Networks.

(a) Applicability. The closed formulary applies to all drugs that are prescribed and dispensed for outpatient use for claims not subject to a certified network.

(b) Preauthorization for claims subject to the division's closed formulary.

(1) Preauthorization is only required for:

(A) drugs identified with a status of "N" in the current edition of the ODG Treatment in Workers' Comp (ODG) / Appendix A, ODG Workers' Compensation Drug Formulary, and any updates;

(B) any prescription drug created through compounding; and

(C) any investigational or experimental drug for which there is early, developing scientific or clinical evidence demonstrating the potential efficacy of the treatment, but that is not yet broadly accepted as the prevailing standard of care as defined in Labor Code §413.014(a).

(2) When §134.600(p)(12) of this title (Preauthorization, Concurrent Utilization Review, and Voluntary Certification of Health Care) conflicts with this section, this section prevails.

(1) An intrathecal drug delivery system requires preauthorization under §134.600 of this title, and the preauthorization request must include the prescribing doctor's drug regimen plan of care and the anticipated dosage or range of dosages for the administration of pain medication.

(2) Refills of an intrathecal drug delivery system with drugs excluded from the closed formulary, which are billed using Healthcare Common Procedure Coding System (HCPCS) Level II J codes, and submitted on a CMS-1500 or UB-04 billing form, require preauthorization on an annual basis. Preauthorization for these refills is also required whenever:

(A) the medications, dosage or range of dosages, or the drug regimen proposed by the prescribing doctor differs from the medications, dosage or range of dosages, or drug regimen previously preauthorized by that prescribing doctor; or

(B) there is a change in prescribing doctor.

(d) Treatment guidelines. Except as provided by this subsection, the prescribing of drugs must be in accordance with §137.100 of this title (Treatment Guidelines), the division's adopted treatment guidelines.

(1) Prescription and nonprescription drugs included in the division's closed formulary and recommended by the division's adopted treatment guidelines may be prescribed and dispensed without preauthorization.

(2) Prescription and nonprescription drugs included in the division's closed formulary that exceed or are not addressed by the division's adopted treatment guidelines may be prescribed and dispensed without preauthorization.

(3) Drugs included in the closed formulary that are prescribed and dispensed without preauthorization are subject to retrospective review of medical necessity and reasonableness of health care by the insurance carrier under subsection (g) of this section.

(e) Appeals process for drugs excluded from the closed formulary.

(1) When the prescribing doctor determines and documents that a drug excluded from the closed formulary is necessary to treat an injured employee's compensable injury and has prescribed the drug, the prescribing doctor, other requester, or injured employee must request approval of the drug by requesting preauthorization, including reconsideration, under §134.600 of this title and applicable provisions of Chapter 19 of this title (Licensing and Regulation of Insurance Professionals).

(2) If an injured employee or a requester other than the prescribing doctor requests preauthorization and a statement of medical necessity, the prescribing doctor must provide a statement of medical necessity to facilitate the preauthorization submission under §134.502 of this title (Pharmaceutical Services).

(3) If preauthorization for a drug excluded from the closed formulary is denied, the requester may submit a request for medical dispute resolution under §133.308 of this title (MDR of Medical Necessity Disputes).

(4) In the event of an unreasonable risk of a medical emergency, an interlocutory order may be obtained in accordance with §133.306 of this title (Interlocutory Orders for Medical Benefits) or §134.550 of this title (Medical Interlocutory Order).

(f) Initial pharmaceutical coverage.

(1) Drugs included in the closed formulary that are prescribed for initial pharmaceutical coverage under Labor Code §413.0141 may be dispensed without preauthorization and are not subject to retrospective review of medical necessity.

(2) Drugs excluded from the closed formulary that are prescribed for initial pharmaceutical coverage under Labor Code §413.0141 may be dispensed without preauthorization and are subject to retrospective review of medical necessity.

(g) Retrospective review. Except as provided in subsection (f)(1) of this section, drugs that do not require preauthorization are subject to retrospective review for medical necessity under §133.230 of this title (Insurance Carrier Audit of a Medical Bill) and §133.240 of this title (Medical Payments and Denials), and applicable provisions of Chapter 19 of this title.

(1) Health care, including a prescription for a drug, provided under §137.100 of this title is presumed reasonable as Labor Code §413.017 specifies, and is also presumed to be health care reasonably required as defined by Labor Code §401.011(22-a).

(2) For an insurance carrier to deny payment subject to a retrospective review for pharmaceutical services that are recommended by the division's adopted treatment guidelines in §137.100 of this title, the denial must be supported by documentation of evidence-based medicine that outweighs the presumption of reasonableness established under Labor Code §413.017.

(3) A prescribing doctor who prescribes pharmaceutical services that exceed, are not recommended, or are not addressed by §137.100 of this title must provide documentation on request under §134.500(13) of this title (Definitions) and §134.502(e) and (f) of this title.

§134.540.Closed Formulary for Claims Subject to Certified Networks.

(a) Applicability. The closed formulary applies to all drugs that are prescribed and dispensed for outpatient use for claims subject to a certified network.

(b) Preauthorization for claims subject to the division's closed formulary. Preauthorization is only required for:

(1) drugs identified with a status of "N" in the current edition of the ODG Treatment in Workers' Comp (ODG) / Appendix A, ODG Workers' Compensation Drug Formulary, and any updates;

(2) any prescription drug created through compounding; and

(3) any investigational or experimental drug for which there is early, developing scientific or clinical evidence demonstrating the potential efficacy of the treatment, but that is not yet broadly accepted as the prevailing standard of care as defined in Labor Code §413.014(a).

(1) An intrathecal drug delivery system requires preauthorization under the certified network's treatment guidelines and preauthorization requirements in Insurance Code Chapter 1305 and Chapter 10 of this title (Workers' Compensation Health Care Networks).

(B) there is a change in prescribing doctor.

(d) Treatment guidelines. The prescribing of drugs must be under the certified network's treatment guidelines and preauthorization requirements in Insurance Code Chapter 1305 and Chapter 10 of this title. Drugs included in the closed formulary that are prescribed and dispensed without preauthorization are subject to retrospective review of medical necessity and reasonableness of health care by the insurance carrier under subsection (g) of this section.

(e) Appeals process for drugs excluded from the closed formulary.

(1) When the prescribing doctor determines and documents that a drug excluded from the closed formulary is necessary to treat an injured employee's compensable injury and has prescribed the drug, the prescribing doctor, other requester, or injured employee must request approval of the drug in a specific instance by requesting preauthorization under the certified network's preauthorization process established in Chapter 10, Subchapter F of this title (Utilization Review and Retrospective Review) and applicable provisions of Chapter 19 of this title (Licensing and Regulation of Insurance Professionals).

(f) Initial pharmaceutical coverage.

(g) Retrospective review. Except as provided in subsection (f)(1) of this section, drugs that do not require preauthorization are subject to retrospective review for medical necessity under §133.230 of this title (Insurance Carrier Audit of a Medical Bill), §133.240 of this title (Medical Payments and Denials), Insurance Code Chapter 1305, and applicable provisions of Chapters 10 and 19 of this title.

(1) For an insurance carrier to deny payment subject to a retrospective review for pharmaceutical services that fall within the treatment parameters of the certified network's treatment guidelines, the denial must be supported by documentation of evidence-based medicine that outweighs the evidence-basis of the certified network's treatment guidelines.

(2) A prescribing doctor who prescribes pharmaceutical services that exceed, are not recommended, or are not addressed by the certified network's treatment guidelines is required to provide documentation on request under §134.500(13) of this title (Definitions) and §134.502(e) and (f) of this title.

§134.550.Medical Interlocutory Order.

(a) The purpose of this section is to provide a prescribing doctor or pharmacy an ability to obtain a medical interlocutory order when preauthorization denials of previously prescribed and dispensed drugs excluded from the closed formulary pose an unreasonable risk of a medical emergency as defined in §134.500(7) of this title (Definitions) and Insurance Code §1305.004(a)(13).

(b) A request for an interlocutory order that does not meet the criteria described by this section may still be submitted under §133.306 of this title (Interlocutory Orders for Medical Benefits).

(1) injured employee name;

(2) date of birth of injured employee;

(3) prescribing doctor's name;

(4) name of drug and dosage;

(5) requester's name (pharmacy or prescribing doctor);

(6) requester's contact information;

(7) a statement that a preauthorization request for a previously prescribed and dispensed drug, which is excluded from the closed formulary, has been denied by the insurance carrier;

(8) a statement that an independent review request has already been submitted to the insurance carrier or the insurance carrier's utilization review agent under §133.308 of this title (MDR of Medical Necessity Disputes);

(9) a statement that the preauthorization denial poses an unreasonable risk of a medical emergency as defined in §134.500(7) of this title;

(10) a statement that the potential medical emergency has been documented in the preauthorization process;

(11) a statement that the insurance carrier has been notified that a request for a medical interlocutory order is being submitted to the division; and

(12) a signature and the following certification by the medical interlocutory order requester for paragraphs (7) - (12) of this subsection, "I hereby certify under penalty of law that the previously listed conditions have been met."

(d) The division will process and approve a complete request for a medical interlocutory order under this section. At its discretion, the division may consider an incomplete request for a medical interlocutory order.

(e) The request for a medical interlocutory order must be in writing and must contain the information in subsection (c) of this section. A convenient form that contains the required information is on the division's website at https://www.tdi.texas.gov/forms/form20numeric.html.

(f) The requester must provide a copy of the request to the insurance carrier, prescribing doctor, injured employee, and dispensing pharmacy, if known, on the date the requester submits the request to the division.

(g) An approved medical interlocutory order is effective retroactively to the date the division received the complete request for the medical interlocutory order.

(h) Notwithstanding §133.308 of this title:

(1) A request for reconsideration of a preauthorization denial is not required prior to a request for independent review when pursuing a medical interlocutory order under this section. If a request for reconsideration or a medical interlocutory order request is not initiated within 15 days from the initial preauthorization denial, then the opportunity to request a medical interlocutory order under this section does not apply.

(2) If pursuing a medical interlocutory order after denial of a reconsideration request, a complete medical interlocutory order must be submitted within five working days of the reconsideration denial.

(i) An appeal of the independent review organization (IRO) decision relating to the medical necessity and reasonableness of the drugs contained in the medical interlocutory order must be submitted under §133.308(t) of this title.

(j) The medical interlocutory order continues in effect until the later of:

(1) final adjudication of a medical dispute about the medical necessity and reasonableness of the drug contained in the medical interlocutory order;

(2) expiration of the period for a timely appeal; or

(3) agreement of the parties.

(k) If a requester withdraws a request for medical necessity dispute resolution, the requester accepts the preauthorization denial.

(l) A party must comply with a medical interlocutory order entered under this section, and the insurance carrier must reimburse the pharmacy for prescriptions dispensed under a medical interlocutory order.

(m) The insurance carrier must notify the prescribing doctor, injured employee, and the dispensing pharmacy once reimbursement is no longer required under subsection (j) of this section.

(n) Payments made by insurance carriers under this section may be eligible for reimbursement from the subsequent injury fund under Labor Code §§410.209 and 413.055 and applicable rules.

(o) A decision issued by an IRO is not an agency or commissioner decision.

(p) A party may seek to reverse or modify a medical interlocutory order issued under this section if:

(1) a final determination of medical necessity has been rendered; and

(2) the party requests a benefit contested case hearing (CCH) from the division's chief clerk no later than 20 days after the date the IRO decision is sent to the party. A benefit review conference is not a prerequisite to a division CCH under this subsection. Except as provided by this subsection, a division CCH must be conducted under Chapters 140 and 142 of this title (Dispute Resolution--General Provisions and Dispute Resolution--Benefit Contested Case Hearing).

(q) The insurance carrier may dispute an interlocutory order entered under this title by filing a written request for a hearing under Labor Code §413.055 and §148.3 of this title (Requesting a Hearing).

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 November 8, 2024.

TRD-202405475

Kara Mace

General Counsel

Texas Department of Insurance, Division of Workers' Compensation

Effective date: November 28, 2024

Proposal publication date: August 23, 2024

For further information, please call: (512) 804-4703

28 TAC §134.506, §134.510

STATUTORY AUTHORITY. The commissioner of workers' compensation adopts the repeal of §134.506 and §134.510 under Labor Code §§408.028, 413.0511, 402.00111, 402.00116, and 402.061, and Insurance Code Chapter 1305.