The Texas Workers' Compensation Commission (the commission) proposes amendments to §§134.503, concerning Reimbursement Methodology and 134.504, concerning Pharmaceutical Expenses Incurred by the Injured Employee.

The Texas Register published text shows words proposed to be added to or deleted from the current text, and should be read to determine all proposed changes.

The amendments are proposed to implement a statutory change enacted by House Bill 833 during the 78th Texas Legislature, 2003, in which a new subsection (e) was added to Texas Labor Code §408.028 to allow an injured employee the option of obtaining a brand name drug at their own expense rather than accepting a generic pharmaceutical drug or over-the-counter alternative to a prescription drug prescribed by a health care provider. As amended the statute provides a means for the employee to be responsible for paying the difference between the cost of the brand name drug and the cost of the generic pharmaceutical drug or the cost of an over-the-counter alternative to a prescription drug. The employee may not seek reimbursement for the difference in cost from an insurance carrier and is not entitled to use the medical dispute resolution provisions of Chapter 413 of the Texas Labor Code with regard to the amount charged by the health care provider. As a result of this new statutory language, a health care provider's receipt of payment from an employee does not violate §413.042 of the Texas Labor Code concerning Private Claims, Administrative Violation. There is no change to the duty of a health care provider to prescribe generic prescription drugs when available and clinically appropriate and to prescribe over the counter medications in lieu of a prescription drug when clinically appropriate. These proposed amendments to §§134.503 and 134.504 implement changes made as a result of the addition of new §408.028(e).

The commission proposes to amend §134.503(b) establishing the manner in which a pharmacist should dispense a generic drug when it is prescribed, or when a prescription does not require the use of a brand name drug and the manner in which a pharmacist should dispense a brand name drug when the injured employee chooses to receive a brand-name drug instead of the prescribed generic drug. The rule as amended allows an employee to decline a generic drug and to opt for a brand name drug by agreeing to pay the additional cost.

Currently, §134.504 provides a process for the injured employee to obtain reimbursement for drugs that have been purchased out-of-pocket. Proposed amendments to §134.504 clarify the existing process for the injured employee to obtain reimbursement for drugs that have been purchased out-of-pocket. Proposed new subsection (b) provides the process and the responsibilities of the dispensing health care provider, the employee and the carrier when an employee chooses to pay the difference in cost between generic drugs and brand name drugs. The proposed amended language necessitates re-numbering the subsections and paragraphs within the rule.

Judy Bruce, Director of Medical Review, has determined that for the first five-year period the proposed rules are in effect there will not be fiscal implications for state or local governments as a result of enforcing or administering the rule because there will be no change in the process for these entities.

Local government and state government as a covered regulated entity will be impacted in the same manner as described later in this preamble for persons required to comply with the rules as proposed.

Ms. Bruce has also determined that for each year of the first five years the rules as proposed are in effect the public benefits anticipated as a result of enforcing the amended rules will be an improved system for pharmaceutical delivery that will provide positive benefits to all participants in the system. The proposed rule amendments benefit system participants by implementing the changes in the Texas Labor Code.

The proposed amended rules will provide employees additional access to brand name drugs by allowing the employee to chose to pay the difference in cost between generic and brand name drugs. The employee's ability to choose to pay the additional cost of a brand name drug in the workers' compensation system is similar to other health care systems that allow the selection of a brand name drug. Allowing choices similar to those that employees are familiar with in other health care systems avoids confusion regarding the delivery of pharmacy services in the workers' compensation system. In addition, injured employees and pharmacists will benefit from the proposed amendments because the clarification regarding reimbursement and the procedures provided by the proposed amendments will encourage pharmacists to provide services for injured employees.

The benefits of the proposed amendments to employers is the assurance that their injured employees are receiving appropriate and medically necessary medication and that their employers have pharmaceutical choices similar to other health care systems.

Insurance carriers will benefit from the clarification provided by the amendments of the carrier's responsibilities when the employee chooses to pay the difference in cost between generic and brand name drugs.

Prescribing health care providers and pharmacists will benefit from the proposed amended rules in that they will have clear guidelines to follow when prescribing and filling prescriptions for drugs. Clear guidelines outlining prescribing and reimbursement will assist the prescribing health care provider and pharmacist in making decisions and should result in a reduction in disputes. The proposed rules will also encourage pharmacists to provide services for injured employees.

There will be minimal anticipated economic costs to persons who are required to comply with the rules as proposed. The decision to pay the difference in cost between generic and brand name drugs is the decision of the employee. If the employee is not able to pay the difference between the drugs, the employee will receive the generic drug that was prescribed by their health care provider.

The financial impact on a pharmacy will vary depending on that pharmacy's current practice of dispensing generics versus name brand drugs, and the pharmacy's profit margin for generic drugs versus name brand drugs. There are no foreseeable economic costs to insurance carriers or health care providers as a result of the proposed amendments.

There will be no adverse economic impact on small businesses or on micro-businesses as a result of the proposed amendments. There will be no difference in the cost of compliance for small businesses and micro-businesses as compared to large businesses because the same basic processes and procedures apply to all entities regardless of size.

Comments on the proposal must be received by 5:00 p.m., December 17, 2003. You may comment via the Internet by accessing the commission's website at www.twcc.state.tx.us and then clicking on "Laws, Rules & Forms" and then "Proposed Rules." This medium for commenting will help you organize your comments by rule chapter. You may also comment by emailing your comments to RuleComments@twcc.state.tx.us or by mailing or delivering your comments to Linda Velásquez, Legal Services, Mailstop #4-D, Texas Workers' Compensation Commission, 7551 Metro Center Drive, Suite 100, Austin, Texas 78744-1609.

Commenters are requested to clearly identify by number the specific rule and paragraph commented upon. The commission may not be able to respond to comments that cannot be linked to a particular proposed rule. Along with your comment, it is suggested that you include the reasoning for the comment in order for commission staff to fully evaluate your recommendations.

Based upon various considerations, including comments received and the staff's or commissioners' review of those comments, or based upon the commissioners' action at the public meeting, the rule as adopted may be revised from the rule as proposed in whole or in part. Persons in support of the rule as proposed, in whole or in part, may wish to comment to that effect. Commenters may wish to express their opinion regarding an employee's ability to refuse a generic prescription, and include references to statutory authority supporting that opinion. A public hearing on this proposal will be held on December 17, 2003 at the Austin central office of the commission (7551 Metro Center Drive, Suite 100, Austin, Texas 78744-1609). Those persons interested in attending the public hearing should contact the commission's Office of Executive Communication at (512) 804-4430 to confirm the date, time, and location of the public hearing for this proposal. The public hearing schedule will also be available on the commission's website at www.twcc.state.tx.us.

These amendments are proposed pursuant to 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; Texas Labor Code §402.061, which authorizes the commission to adopt rules necessary to administer the Act; 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; 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; Texas Labor Code §408.025, that requires the commission to specify by rule what reports a health care provider is required to file; and Texas Labor Code §408.028, that requires health care practitioners providing care to an employee to prescribe any necessary prescription drugs in accordance with applicable state law.

The amendments to these rules are proposed under: Texas Labor Code, §402.042, §402.061, §406.010, §408.021(a), §408.025, and §408.028.

The previously cited sections of the Texas Labor Code are affected by this proposed rule action. No other code, statute, or article is affected by this rule action.