COMMENT: Commenter contended that carriers insist on paying claims every 45 days. Hence, claims will always be disputed and never be paid.

RESPONSE: The Commission disagrees. Carriers are required to pay medical bills in accordance with Texas Labor Code §408.027 and §413.011.

§134.504 Pharmaceutical Expenses Incurred by the Injured Employee

COMMENT: Commenter recommended changing "or" in proposed §134.504 (c) to "and notify the injured employee of the payment or denial in accordance with §133.304.". This will decrease confusion, questions, and disputes regarding the form and format of notification to the injured employee. Another commenter suggested that "or" be replaced with "and/or."

RESPONSE: The Commission disagrees. "(And" is unnecessary. The injured employee will be paid, or have the payment reduced or denied. If payment is made in full, the carrier is not required to provide an explanation. Only in the event of a reduction or denial would notice and an explanation be needed.

COMMENT: Commenter noted that there are no stipulations as to sanctions against the insurance carrier for delays in reimbursement of the patient for over-the-counter medications.

RESPONSE: The Commission disagrees. Failure of an insurance carrier to take timely action on an employee's request for reimbursement is a violation of Texas Labor Code §415.002 and should be reported to the Division of Compliance and Practices.

COMMENT: Commenter believed that there is a disconnect between the claimant's inability to refuse a brand name at the pharmacy and the claimant being able to pay for brand name and seek reimbursement for the brand drug directly from the carrier. Commenter suggests that wording be included specifying that when claimant is submitting documentation for reimbursement for out-of-pocket expenses, the carrier is only responsible for reimbursing generic medications unless the claimant submits supporting documentation for the brand drug.

RESPONSE: The Commission disagrees. Section 134.502 provides that a doctor shall prescribe generic prescription drugs when available and clinically appropriate. If the doctor believes the brand name is medically necessary the doctor must specify that brand name drugs be dispensed. It is not the option of the injured employee to choose generic or brand name drugs. Therefore, in the event an injured employee seeks reimbursement for a prescription drug, the reimbursement should be for what was specified on the prescription.

COMMENT: Commenter suggested that the Commission establish a limit on the amount of over-the-counter medication that will be reimbursed within a set time period similar to the limitation found in §134.502(c) on prescription drugs.

RESPONSE: The Commission disagrees. Reimbursement for over-the-counter medications is limited by the doctor's prescription. The Commission disagrees that a quantity limit for dispensing over-the-counter medications is necessary. Over-the-counter medications are generally less expensive than prescription medications and may be paid for initially by the injured employee. It is not necessary to place a limit on the quantity of over the counter medications.

COMMENT: The commenter believed that the intent of HB-2600 was to keep reimbursement for injured employees simple. Once the commission gets an injured employee into the medical dispute resolution process, it becomes more complicated than what the average employee should have to go through.

RESPONSE: The Commission disagrees. The law requires the Commission to establish rules for employee reimbursement for out of pocket expenses for medications. In the event a request for reimbursement is denied or reduced, the injured employee is entitled to dispute that action. The rules as adopted do keep the process as simple as possible. The rules do not require the employee to shop around between over-the-counter medications or between brand name and store-name over-the-counter medications. Reimbursement for over-the-counter medications is set at the retail price of the lowest package quantity reasonably available that will fill the prescription.

COMMENT: Commenter suggested that when an injured employee is seeking reimbursement for out-of-pocket expenses, their letter should be personally signed and contain the following items: copy of prescription, number of units or quantity (tablets, capsules, liquid, or suppositories), prescription label, receipt indicating amount paid, employee's name and carrier's claim number, mailing address, date of injury, and social security number.

RESPONSE: The Commission disagrees. The basic information required adopted §134.504 is sufficient. The rule lists information that should be included in the request for the carrier to identify the claim, the amount of reimbursement requested, and the over-the-counter medication prescribed. If more information is needed, the carrier can contact the injured employee or the prescribing doctor.

COMMENT: Commenter questioned why it would become necessary for an injured employee to purchase medications out of pocket. Commenter believed there would be few over the counter prescriptions if the injured employee must bill. If the employee has an account at the pharmacy why can't the pharmacy bill? By the time an injured employee bills, the employee has lost the cost of the drug, if they have it (most don't), interest for over 45 days (when you include mail), maybe some of the cost if denied, and the possible hassle of medical dispute resolution.

RESPONSE: The Commission disagrees. Texas Labor Code §408.028(d) requires the Commission to adopt rules allowing employees to obtain reimbursement for money spent on prescribed over-the-counter medications. Section 134.504 implements the law and extends reimbursement to prescription drugs as well. The rule does not prevent a pharmacist from dispensing an over-the-counter medication and billing the carrier. However, in the event an injured employee has paid out-of-pocket for prescribed medications the rule provides a procedure for recovering that money.

COMMENT: Commenter felt that §134.504 has great potential for cost-shifting of products generally used in the home and unrelated to the injured employee's compensable injury, potentially increasing costs in the workers' compensation system.

RESPONSE: The Commission disagrees. Injured employees must provide a copy of the doctor's prescription along with their request for reimbursement. This prescription will have an indication that it is related to a workers' compensation claim and is required to be medically necessary for treatment of a compensable injury to be reimbursed.

§134.505 Chronic Pain Prescriptions

COMMENT: Some commenters supported the adoption of §134.505. Commenters believed that this rule would address a problematic issue wherein many treating doctors are not managing the injured employee's use of prescription drugs in a proper manner.

A commenter suggested that the documentation submitted by the treating doctor be produced on a standardized form.

One commenter contended that nothing in §408.028 authorizes the commission to prohibit or label as presumptively unreasonable the use of opioids. Proposed §§134.505-134.506 demonstrate a complete lack of understanding of and compliance with Senate Bill 20, Section 1, Title 71, Article 4495C the Chronic Pain Treatment Act and the amendment, Section 1, Section 6, Article 4495C, Revised Statute Application of Act to Chemically Dependent Persons. The proposed rules also run contrary to the Texas State Board of Medical Examiners, §§170.1-170.3, Authority of a Physician to Prescribe for the Treatment of Pain. Commenter believed that the proposed rules, in particular §134.505; purport to instruct medical doctors to ignore this applicable law and the standard of care and that the rules run contrary to the Drug Addiction Treatment Act of 2000, The National Institute on Drug Abuse Policies and Procedures, The Federation of State Medical Boards of the United States Model Guidelines for the Use of Controlled Substances for the Treatment of Pain, The American Pain Society's Consensus Statement on the Use of Opioids for the Treatment of Chronic Pain, The American Academy of Pain Medicine's Consensus Statement on the Necessity for Early Evaluation and Treatment of the Chronic Pain Patient, and numerous journal reviewed articles on the treatment of chronic pain. Commenter stated that §134.505 ignores and violates the International Narcotic Control Board section 21 of the Code of Federal Regulations and the Intractable Pain Treatment Act of Texas and that State and federal laws have provisions that are more extensive and more clinically appropriate than are the provisions of this proposed rule and that this section should be removed entirely.

Some commenters suggested that §134.505(c)(1) is an illegal invasion of the patient's privacy because it requires a drug screening without cause and it cannot be assumed that every patient taking opioids is likely to become a drug abuser. Commenters believed that drug screening should only be required if a suspicion arises about drug abuse or diversion. One commenter did not think that patients on opioids should be labeled as drug addicts and believed that is essentially what §134.505 and §134.506 do.

Many commenters felt that §134.505 is a treatment guideline and should be deleted since treatment guidelines must be nationally recognized and outcome based. Commenters stated that treatment guidelines should be directed at the physicians, not the suppliers and felt that problems exist when payers seek to enforce treatment guidelines through pharmaceutical benefits as they are dispensed.

One commenter pointed out that this does not alleviate the problem that exists now- the supplier is in the middle and unable to comply. Commenter felt that §134.505 result in operational and clinical procedural problems since it is impossible for someone other than the physician to follow this guideline. Commenter asked how a pharmacist could comply with the opioid guidelines when they are written for the doctor and the pharmacy has no access to any of the records.

Some commenters pointed out that §134.505 was based on a single payer on-line pharmacy system that Texas does not have.

Many commenters pointed out that §134.505 states that payment for the medications "shall" be denied for inadequate documentation, non-compliance, misuse, or very subjective reasons- not for reasons based on the medical necessity of the treatment and that the rule ties payment to " documentation of substantial reduction of the patient's pain intensity and continuing substantial improvement in the patient's function." Commenters felt that in many cases there may be substantial relief of pain but the patient's function may not improve and the rule creates a presumption that without documentation of substantial improvement, the treatment is not reasonable or medically necessary. Commenters believed that there is no statutory authority or factual authority for creating this presumption, nor the standards for continuing or denying payments.

Another commenter contended that the burden of proof needs to lie with the carrier and the carrier needs to justify any denials of payment for these prescriptions by presenting documentation of their beliefs that the prescribing patterned deviate from those practice guidelines and the current Commission treatment guidelines.

One commenter requested clarification that all approvals of treatment plans for chronic pain medications be undertaken and completed on-line, in a timely manner, before the prescription is presented to the pharmacist. Commenter believed that otherwise, the pharmacist will be unaware of the terms or state of approval of any treatment plan and a pharmacist should not be required to ascertain or document medical necessity.

A commenter was very concerned that the regulations proposed are an attempt by insurance carriers to impose regulations on treating doctors that make "chronic" pain in a brief period of time and that the wording of the pharmaceutical benefits section opens the door to define any treatment lasting over three months as "not reasonable and medically necessary" .

Commenter suggested that when a patient has achieved the level of chronic care, it is appropriate to achieve a maintenance level of opiates simply to achieve a continued therapeutic affect and the provision that patients show improvement over the first three months of opioid therapy is of some concern. It may take more time to achieve an appropriate medication level for the patient to become active and for an arbitrary time of three months to be stipulated is unreasonable. A statement of why prior measures may have failed is an exercise in speculation and serves no useful purpose. A statement that the treating doctor has conducted appropriate screening is part of the regular record of the patient kept by the treating physician. A six-month treatment plan cannot be done with any degree of accuracy because treatment conditions are frequently fluid and have to be adjusted to fit the changing situation.

Commenters contended that wording in the proposed rule adds extensive reporting to an already cumbersome system. Commenters felt that the reporting requirements discouraged the use of opiates and it would be too much work to prescribe these drugs. One commenter stated that physicians go to school and should risk being questioned by their boards not the Commission or a carrier when treating an injured employee. Many commenters pointed out that this information could be obtained from provider progress notes that are already available to the carrier as part of the office record and specific narratives are unnecessary.

Commenters believed that the proposed rule will require a substantial increase in the number of visits per claim, not just for the initial "drug screening, consultations, and all other treatment trials" required, but to comply with "at least every 60 days" updates and contended that after the establishment of an appropriate medication regimen, it is often not necessary to see a patient every 60 days and such a requirement would create an unnecessary inconvenience on the patient. However, the commenter noted that if the patient's pain control is not improving then this time framework might be too long. Commenter also stated that increasing the number of visits is contrary to the Paper Reduction Act.

One commenter suggested that there should be evidence that a prescribing doctor has seen the patient within 10 days of continuing a chronic pain medication and that too many times medications are continued without examination of the patient.

A commenter suggested that the prescribing doctor outline lab tests if a patient is to remain on chronic pain medications.

It was recommended that all references to treating doctor be changed to read treating/referral doctor and the commenter pointed out that as currently written, §134.505 only applies to treating doctors. The commenter stated that referral doctors often prescribe drugs to injured employees and should be subject to the requirements set forth in this rule and suggested that no later than 10 days after a referral doctor begins treating the injured employee with opioids for treatment of chronic, non-cancer pain, the referral doctor shall submit a written report to the treating doctor and carrier in order for the carrier to pay for such treatment. Commenter believed that the written report must include the information set forth in subsection (b) of this section and a referral doctor must submit to the treating doctor and carrier the information set forth in subsection (c) of this section at least every 60 days when treating with opioids.

Some commenters felt that §134.505 is a blatant and unauthorized attempt to limit the treatment for chronic conditions that conflicts with the entitlement given in Texas Labor Code §408.021. Commenter felt that §134.505 is unusually strict and noted that the proposed rule was based on anecdotal experience and those who are board certified in pain medicine and/or board certified in addiction medicine were not consulted. Commenter stated that there is no scientific evidence to support the Commission's position on restricting pain relief and that the Commission failed to state a reasoned justification for the proposed rule.

Commenters believed that health care providers will face arbitrary decisions by carriers to deny payment based upon their determinations of what constitutes adequate compensation, substantial reduction in the patient's pain, substantial improvement in the patient's function, noncompliance, misuse or abuse and that determination of reasonable and necessary usually falls to an economic consideration. One commenter contended that an arbitrary decision to presume that " such treatment (opioids) without documentation of substantial improvement is presumed to be not reasonable or medically necessary" is inhumane and several commenters felt that continued treatment for as long as the pain persists is essential. One commenter felt that such determinations need to be made by a specialist in the management of chronic pain and that the effect of §134.505 will be to substantially reduce the ability of the injured employees to receive appropriate treatment for chronic pain. Another commenter contended that disputes over payment for medication will be numerous and the dispute resolution system will be overwhelmed. A commenter believed that although addiction does exist, the percentage is not high particularly on the pain medications and commenter didn't believe that it would run into a high cost because the percentage is so low.

Commenter inquired as to who determines ambiguous inadequate documentation and ambiguous non-compliance. Commenter believed that claims adjusters are making medical decisions attempting practicing medicine without a Texas license for the purpose for denying paying claims.

One commenter recommended adding psychotropic drugs to the list since many patients who experience chronic pain are on these drugs. Another questioned the source of the definition of chronic pain given in §134.505(a). A commenter contended that the Commission has made Vicodin sound like Percodan.

Commenter recommended including the example in §134.505(f) should be contained in the preamble to the rule rather than the rule itself.