Commenters went on to point out that the origin of the proposed rules is described as being based on faulty sources and concepts devoid of knowledge and awareness of the many modern scientific studies, laws, and treatment guidelines that are followed by pain specialists throughout the state and asked where the clinical studies were to support these rules. Commenters believed that without the participation and contribution of a pain specialist physician, the rule-making process was fatally flawed from its onset and suggested pulling the proposed rules until the commission has accurate data upon which to base its regulations and noted that opioids are not evil when used appropriately. One commenter noted that a good resource for the Commission would be the work group that is being formed by the Board of Pharmacy that includes the prescribing organizations and regulatory organizations. Commenter noted that there are frantic, desperate, suicidal calls when people get abruptly taken off their medication.

RESPONSE: The Commission recognizes that the issues surrounding chronic pain are important and may need to be addressed by rule; however, after reviewing the comments on proposed §134.505, the Commission has decided not to adopt this section pending further examination of the issues.

§134.506 Outpatient Drug Formulary

COMMENT: Commenter recommended that the following language be substituted for the language currently proposed for adoption: Over-the-counter medications with a prescription from a physician shall be reimbursed in the manner set forth in §134.503(c).

RESPONSE: The Commission agrees and has inserted language in §134.506 referencing §134.503.

COMMENT: There were a number of comments regarding the "off-label" use of prescription drugs. A commenter was pleased that under proposed §134.506 Outpatient Drug Formulary, the Commission adopts an open formulary as defined in §134.500(a)(4) and urged the Commission to allow for public notice and comment at any time the commission considers limiting access to drugs or otherwise considers a limited outpatient drug formulary.

One commenter suggested that a better wording would of §134.506 (a) would be: "The insurance carrier shall pay for prescriptions for off label indications when used in accordance with current medical standards and established major medical organizations and prescribed in compliance with clinical indications, contradictions, precautions, and warning as presented in medical books, journals, seminars, and/or conferences."

Another commenter was of the opinion that off-label drugs are used appropriately in a significant percentage of cases in accordance with current medical standards. Oftentimes once a drug is FDA approved for one purpose, even though subsequently it is found to be appropriate for another purpose, the manufacturer will not go back through the expensive approval process for that purpose. Commenter felt that §134.506 needs a clear and explicit statement that this subsequent finding of additional benefits of medications for other symptoms that are different from those symptoms and benefits of medications for other FDA approval process is a widespread phenomenon throughout the many fields of medicine.

Commenter suggested that the rule specify the Physician's Desk Reference (PDR) alone and/or references derived solely from it are insufficient as tools to render a proper decision about the medical appropriateness of a prescription of a medication to relieve pain. The medical literature published after the initial PDR-approved investigations must also be considered.

RESPONSE: The Commission disagrees that the suggested additions to the wording in §134.506 are necessary; however, subsection (a) has been re-worded to clarify that off-label uses of prescription drugs are sometimes appropriate. The prescribing doctor may cite medical findings and publications in support of an off-label use of a prescription medication. Not all books, seminars, and journals may be authoritative sources. The carrier must review the documentation provided to make its decision and should consider the reputation of the resource provided in support, as well as the conclusion of the resource.

COMMENT: Commenter suggested the removal of §134.506(b) stating it is a poor attempt to establish an open formulary and it reads more like an outpatient drug rehab treatment guideline. Commenter felt that this is a violation of both the intent and wording of HB-2600. Much language in this section is word for word from the State of Washington workers' compensation rules, which are of little use in Texas. Because Washington is a single payer state, they utilize an on-line automated paperless system to process pharmacy claims. Very few workers' compensation carriers are set up to handle claims in this manner. Because of this, most of these proposed rules in this section will cause more problems than they will solve. Commenter felt many of the areas addressed in this section have operational concerns. Additionally, many of the items addressed in this section are already addressed in other areas, especially §134.506(a)(2), (c), which flagrantly violates the Texas Labor Code, and (d) of §134.506. Commenter contended that proposed §134.506 is nothing more than additional hoops for pharmacists to jump through to get paid. There is no two-way mechanism for when the carrier has concerns, just one-way. This will result in decreased pharmacists accepting workers' compensation.

RESPONSE: The Commission agrees that §134.506(b) should be removed because they would be somewhat misplaced in this rule. In addition, §134.506(a)(2) has been deleted as unnecessary.

COMMENT: Commenter requested clarification that §134.506(c)(B) applies only to "claimants with a compensable accepted psychiatric disorder"

Commenter suggested that to achieve greater clarity and specificity, this section should incorporate the language in the Mental Health Treatment Guideline. For example, "dependent or toxic" should be modified to be consistent with the language and diagnoses of the Mental Health Treatment Guideline.

Commenter felt that §134.506(c)(5) should be deleted and that it is far too prescriptive and its restrictive concepts cannot even begin to apply appropriately to the extraordinary complicated and numerous variations which occur in the listed clinical circumstances. The list of patient types do not include the many other several circumstances which can or must rely on the use of benzodiazapines to treat IEs.

Commenter suggested that the Commission add SSRI's and MOAI's to the list of drug classifications that are limited to 30 days or remove the restriction altogether. This is too burdensome to track for carriers, doctors and pharmacists to be effective. Benzodiazepines are just one type of psychotropic medication that can be used to treat the same illness as SSRI's and MOAI's.

Commenter contended that the wording on this section does not comply with certain aspects of pain management prescribing practices as established by the standards described previously. For example, some prescriptions are available only in an injectable form but they are used non-injectable routes of administration. Nothing in §408.028 authorized the Commission to prohibit or label as presumptively unreasonable the use of injectable over non-injectable medications or opioids. Limitations as set out in the proposed rules may limit appropriate use of medications.

RESPONSE: The Commission agrees that subsection (c) should be reviewed further to determine whether such reimbursement directions should be included in Commission rules. Therefore it has been removed.

COMMENT: Some commenters believed that §134.506 encourages the payment of prescriptions for conditions not related to the compensable injury and an insurance company should never pay for prescriptions for conditions not related to the compensable injury. The payment of prescriptions for conditions not related to the compensable injury and §134.506 would result in payment of health care benefits not provided for by Texas Labor Code §408.021 and is not in keeping with the intent of the Texas Legislature as expressed in HB-2600. Commenters noted that §134.506(b)(2) and (3) would require the carrier to pay for chemical dependency treatment and detoxification treatment even when the condition did not arise from the compensable injury. Commenters contended that the proposed rule violates the intent of HB-2600 to promote the reduction of pharmaceutical costs and that §134.506 would dramatically increase costs to the system because of the high cost of treatment and any dependency or toxicity due to medications for an unrelated condition will retard recovery of any injury. Commenters point out that the workers' compensation system is not the appropriate mechanism for addressing drug addiction, abuse, or health issues which are not related to the compensable injury and that prescriptions of non-compensable conditions should be paid for by the injured employee's private health care insurance. Commenters recommended that subsection (a)(2) of §134.506 be deleted entirely or that payment for such treatments be voluntary within the sole discretion of the carrier.

Some commenters requested clarification as to how the carrier may grant and terminate "temporary authorization for treatment of unrelated psychiatric disorders" as permitted under subsection (c) of §134.506 without that condition becoming a part of the accepted injury. Commenters recommended specifying that the "temporary" period will end when the non-work injury related condition is no longer a risk to block recovery or a risk to cause relapse of symptoms directly caused by the work injury.

Other commenters stated that unless something is to be mandated, regulations giving discretionary power to carriers should not be included. Commenters believed that the use of the term "authorize" implies preauthorization, and may produce confusion. Carriers already have the ability to do what §134.506 states. Commenter requested an explanation of the relationship between the proposed rule and §124.3 of this title.

Some commenters suggested that "may" should be changed to "shall" throughout §134.506. A commenter believed that the circumstance and the seriousness of the cancer pain is so severe that the carrier having only discretionary obligations to pay for pain medications is ethically untenable. If any medication is found to be medically necessary for the patient to recover from the compensable injury, it should be reimbursed regardless of setting. The language seems to suggest that the carrier has the option of not paying even though it is medically indicated and there is no mode for preauthorization or pre-certification by the pharmacist. Adoption of such a section might result in unnecessary confusion. One commenter recommended changing the language in subsection (c)(1) to require the payment of anti-spasticity medications if medically indicated. A commenter questioned whether the Commission would rather an injured employee injured employee in the emergency room with intractable pain be admitted to the hospital in order to get an injection of opioid or analgesic rather than be given an injection and sent home at a physician's discretion.

Commenter expressed the belief that "temporary coverage" for prescription medications can be stopped at any time as a strategy for ending paying for a claimant's prescription medications.

Some commenters felt that new requirements in §134.506(d) were unduly burdensome and would add unnecessary expense to the system. A commenter recommended deletion of subsection (d)(2) since other provisions of this section allow contact between the carrier and the provider.

Another commenter recommends removing subsection (d)(5) of §134.506 since patients should not be limited to one doctor. That goes against multiple other rules and law allowing the patient the freedom to choose their health care provider.

A commenter pointed out that there might be situations where the treating and referral doctor may each be treating conditions that would require the writing of a prescription or situations where more than one doctor is taking care of the patient. Commenters stated that there is no statutory authority for limiting an injured employee to one doctor.

Commenter recommended that the following new subsection (d)(6) be added to subsection (d) of §134.506: " Reduce or deny reimbursement of the drugs the injured employee is receiving." Recommend that the word " or" be deleted from subsection (d)(4) and added to the end of subsection (d)(5).

Commenters felt that a specialist of similar training should conduct a required medical exam (RME) if the carrier has not used up their ability to request a RME and have exhausted the other remedies listed here. Unless a specialist performs the examination, the assessment is usually meaningless and simply adds days or weeks to a request for specific intervention usually resulting in a worsening clinical situation. The RME request should come from a carrier doctor so the prescribing physician can call and discuss.

Commenters felt that proposed §134.506 (e) is unnecessary and unwarranted given the fact that Texas Labor Code §408.027 sets out a reasonable time frame for review and payment of a medical bill. The Texas Labor Code does not provide the commission with the authority to adopt a rule that adds an additional and very burdensome duty to an insurance company. The requirement to notify the injured employee, pharmacy, and doctor of the insurer's intent to dispute payment of medical bills associated with a specific prescription drug will add unnecessary costs to the Texas workers' compensation system at a time when the Texas Legislature has directed the commission to reduce costs in the system. Commenter suggested deletion of subsection (e) of §134.506. A commenter asked for clarification as to whether or not a carrier's discontinuation of payment for " one or more drugs" in the regimen after adequate prior notification of 15 days indicated that carriers have authority for denying payment for all prescription medications.

Some commenters supported the language requiring carriers to provide a 15-day notice prior to discontinuing reimbursement for one or more drugs. Commenter felt the establishment of a 15-day notice prior to discontinuing is recognition of the critical requirement that medications must be discontinued or tapered in such extreme conditions in a fashion that will not put the patient's health and life in jeopardy. Unfortunately, the 15-day time period is too short for discontinuation of several medications used to treat chronic pain.

A commenter pointed out that there is no language protecting the patient's rights to confidentiality by communications with various parties.

RESPONSE: The Commission has removed §134.506(a)(2), (b), (c), (d), and (e). The Commission agrees that insurance carriers are only responsible for the payment of medications that are reasonable and medically necessary and related to the compensable injury and has removed discretionary language allowing carriers to pay for medications for unrelated conditions. The Commission disagrees that the wording should be changed to "shall" throughout §134.506 for the reasons stated above. The Commission has elected to remove §134.506(d) and agrees with commenters who stated that many of the options outlined in the subsection were already available or required by other rules. The Commission also agreed with commenters who pointed out that limiting the injured employee to one prescribing doctor may create problems. The Commission agreed with commenters that suggested removal of subsection (e); however, the Commission has elected to place a requirement in §134.502(e) that would notify all parties of a possible denial.

The Commission received some comments that were beyond the scope of the proposed rule changes and could not be tied to specific portions of the proposed rules. In some cases the comments contained criticism of the Commission and other system participants. The Commission has answered all comments that the Commission was able to tie to a specific rule or Commission function.

The new rules are adopted pursuant to the Texas Labor Code §402.042, that authorizes the Executive Director to enter orders as authorized by the statute as well as to prescribe the form and manner and procedure for transmission of information to the commission; the Texas Labor Code §402.061, which authorizes the commission to adopt rules necessary to administer the Act; the Texas Labor Code §406.010, that authorizes the commission to adopt rules necessary to specify the requirements for carriers to provide claims service and establishes that a person commits a violation if the person violates a rule adopted under this section; the Texas Labor Code §408.021(a), that states an employee who sustains a compensable injury is entitled to all health care reasonably required by the nature of the injury as and when needed; the Texas Labor Code §408.025, that requires the commission to specify by rule what reports a health care provider is required to file; the Texas Labor Code §408.028, as passed by the 77th Texas Legislature, that requires health care practitioners providing care to an employee to prescribe any necessary prescription drugs in accordance with applicable state law; the Texas Labor Code §413.002, that requires the commission to monitor health care providers and insurance carriers to ensure compliance with commission rules relating to health care including medical policies and fee guidelines; the Texas Labor Code §413.011, as passed by the 77th Texas Legislature, that requires the commission by rule to establish medical policies and guidelines relating to necessary treatments for injuries, and fees, designed to ensure the quality of medical care and to achieve effective medical cost control; the Texas Labor Code §413.012, that requires the commission to review and revise medical policies and fee guidelines at least every two years to reflect current medical treatment and fees that are reasonable and necessary; the Texas Labor Code §413.013 (1) (2) and (3), that require the commission by rule to establish a program for prospective, concurrent, and retrospective review and resolution of a dispute regarding health care treatments and services; a program for the systematic monitoring of the necessity of the treatments administered and fees charged and paid for medical treatments or services including the authorization of prospective, concurrent or retrospective review under the medical policies of the commission to ensure the medical policies and guidelines are not exceeded; and a program to detect practices and patterns by insurance carriers in unreasonably denying authorization of payment for medical services requested or performed if authorization is required by the medical policies of the commission; the Texas Labor Code §413.0141, as passed by the 77th Texas Legislature, regarding initial pharmaceutical coverage; the Texas Labor Code §413.017, that establishes presumption of reasonableness of medical services; the Texas Labor Code §413.031, as passed by the 77th Texas Legislature, that entitles a party, including a health care provider, to a review of a medical service for which authorization for payment has been denied or reduced; the Texas Labor Code §415.002, that establishes an administrative violation for an insurance carrier to: unreasonably dispute the reasonableness and necessity of health care, to violate a commission rule or to fail to comply with the Act; the Texas Labor Code §415.003, as passed by the 77th Texas Legislature, that establishes an administrative violation for a health care provider to: administer improper, unreasonable, or medically unnecessary treatment or services, to violate a commission rule, or to fail to comply with the act; and the Texas Labor Code §415.0035, that establishes an administrative violation for an insurance carrier to deny preauthorization in a manner that is not in accordance with commission rules.

The new rules are adopted pursuant to the Texas Labor Code §402.042, §402.061, §406.010, §408.021(a), §408.025, §408.028, §413.002, §§413.011-413.013 (1) (2) and (3), §413.0141, §413.017, §413.031, §415.002, §415.003, and §415.0035.