By Brain Allen, VP of Government Affairs, Pharmacy Solutions
The California Division of Workers’ Compensation (DWC) has submitted the final MTUS Drug Formulary rule to the Office of Administrative Law (OAL) for their approval. The OAL has up to 30 working days to review the rule and the procedure used to develop the rule to verify compliance with California law. The 30 working day period expires December 7, 2017. Once the rule is approved by the OAL, it will be submitted to the California Secretary of State for formal publication.
There were only minor, typographical changes made to the rule following the second 15-day comment period.
MTUS Drug Formulary Rules
The following is a brief summary of the rule highlights as submitted to the OAL.
- The effective date is January 1, 2018.
- There is a transition period for workers injured prior to January 1, 2018, and receiving medications that are not listed as exempt on the MTUS Drug Formulary. The prescribing physician should request authorization for a treatment plan that would outline the safe weaning or transition of the injured worker to exempt medications, or provide the medical justification to continue the injured worker on their current non-exempt, unlisted, or compounded medications.
- Pharmacy Benefit Manager or network contracts may not be more restrictive than the MTUS Drug Formulary.
- Exempt medications may be prescribed without authorization through prospective review if they are prescribed in accordance with the MTUS Treatment Guidelines.
- Off-label use must be in accordance with the MTUS Treatment Guidelines. Prospect review is not required for the off-label use of an exempt drug if it is recommended by the MTUS Treatment Guidelines. Non-exempt, unlisted or exempt drugs lacking recommendation must be authorized through prospective review.
- Access to medications not listed as exempt on the MTUS Drug Formulary is allowed if the prescribing physician seeks authorization through prospective review and demonstrates appropriate medical necessity.
- Brand name drugs must be authorized through prospective review prior to being prescribed.
- Drugs dispensed by a physician must be authorized through prospective review. However, a physician may dispense a one-time, up to seven-day supply of an exempt medication in the first seven days following the date of injury as long as the medication is prescribed in accordance with the MTUS Treatment Guidelines.
- Compounded medications require authorization through prospective review.
- Non-exempt drugs and unlisted drugs require authorization through prospective review.
- Prospective review may be waived if a medication falls within an approved utilization plan.
- Special Fill – The MTUS Drug List identifies certain medications subject to the special fill policy. Drugs so identified may be dispensed without prospective review if the drug is prescribed at the initial visit within seven days of the date of injury, the prescription is for the supply indicated on the MTUS Drug List, the drug is an FDA-approved generic or single-source brand, and the drug is prescribed in accordance with the MTUS Treatment Guidelines.
- Perioperative Fill - The MTUS Drug List identifies certain medications subject to the perioperative fill policy. The perioperative period is defined as four days prior to surgery and four days following surgery. Drugs identified as perioperative eligible may be dispensed without prospective review if the drug is prescribed during the perioperative period, the prescription is for the supply indicated on the MTUS Drug List, the drug is an FDA-approved generic or single-source brand, and the drug is prescribed in accordance with the MTUS Treatment Guidelines.
- The rule gives permission to the Administrative director to publish the MTUS Drug List using the drug’s NDC, RxCUI or other unique drug code identifier. The Director is not required to publish such a list.
- The rule details a dispute resolution process for disagreements over the medical necessity of pharmacy treatment covered by the MTUS Treatment Guidelines.
- The rule establishes a Pharmacy and Therapeutics Committee and outline the composition of the committee, the application process and conflict of interest policy.
- The rule sets forth the timing and procedure for meetings and how the Committee can make recommendations for changes to the MTUS Drug List.
- P&T Committee is advisory only and its recommendations are not binding on the Administrative Director.
The development of this rule has been a long journey for the California DWC and the various stakeholders. We applaud the DWC for their open and thoughtful process and for listening as we along with many other stakeholders offered comments. As an organization, Mitchell is prepared to handle the changes in processing required by the new MTUS Drug Formulary rule. At this time, we do not anticipate any delays in the January 1, 2018, effective date.
If you have questions about this rule, please contact Brian Allen, Mitchell Pharmacy Solutions’ VP of Government Affairs at Brian.Allen@mitchell.com or at 801.903.5754. If you have questions about how these changes will impact the processing of your prescription claims, please contact your account manager.