Specialty Drug Handbook
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S-1. Specialty Drugs
HHSC defines a specialty drug as one meeting all of the Specialty Drug rule criteria. The specialty drug list (SDL) identifies all drugs meeting these criteria. HHSC publishes the SDL in March and Sept., but we may consider off-cycle updates to address drug shortages.
Refer questions or comments about specialty drugs to firstname.lastname@example.org.
Information for pharmacies
- Any Medicaid-enrolled pharmacy can dispense a drug identified on the SDL for people enrolled in traditional Medicaid.
- A pharmacy may need to enroll in an MCO’s specialty pharmacy network to dispense a drug identified on the SDL.
Information for managed care organizations:
- Medicaid managed care organizations and subcontracted pharmacy benefit managers are required to adopt policies and procedures for reclassifying prescription drugs from retail to specialty drugs that are consistent with rules adopted by the HHSC Executive Commissioner. Refer to Texas Government Code, section 533.005(a)(23)(G).
- The only drugs exclusively provided through the MCO’s specialty pharmacy network are those listed on the SDL.
- MCOs will have three months after a drug is removed from the published SDL to adjust contracts.
Information for prescribing providers:
- Prescribing providers may be asked to send prescriptions for drugs on the SDL to an MCO’s specialty pharmacy network
- Some drugs identified on the SDL may require clinical or non-preferred prior authorization
S-2. Criteria Review
A drug qualifies for inclusion on the SDL if it meets all the rule criteria. Refer to TAC Section 354.1853 (Subchapter F: Specialty Drugs).
A drug will meet these rule criteria if the drug is to treat and is prescribed for a person with a complex, chronic, or rare medical condition that is:
- Debilitating or fatal if left untreated or undertreated
- Has no known cure
HHSC evaluates a drug for inclusion on the SDL after the drug has been on the Medicaid formulary for at least six months. A claim utilization report will identify all pharmacy types dispensing each drug in Medicaid (traditional and managed care). A drug will meet this rule criteria if the utilization report identifies specialty pharmacies are the type of pharmacy dispensing the drug at least 70% of the time. HHSC will consider all drug strengths, specific to the formulation, fulfilling all four specialty drug criteria for inclusion on the SDL.
Special Handling or Storage
HHSC reviews the information submitted by the drug manufacturers on the Electronic Certification of Information. The manufacturer identifies if the drug meets any of the following specifications:
- The manufacturer allows only specific pharmacies or pharmacy chains to dispense the drug
- The drug needs to be administered within less than 48 hours after dispensing
- Requires protective handling (e.g., hazardous drugs with mutagenic, carcinogenic, teratogenic, or adverse reproductive effects, or requires laminar flow hoods for preparation or mixing)
- Requires aseptic techniques for compounding per federal and state standards
- Requires the patient to receive specific labs for therapeutic efficacy, toxicity, or physiological testing (e.g., renal function, liver enzyme tests, complete or partial blood counts) at baseline and during or post-drug treatment
- Requires highly-specialized storage equipment or facilities that are not commonly available in retail pharmacies (e.g., more than just refrigeration)
Special Education and Treatment Maintenance
HHSC will identify if the drug meets both of the following specifications:
- Do patients using the drug require complex education to promote appropriate utilization of the drug, or is there a need to educate on proper storage, preparation, and administration?
- Do patients using the drug require treatment maintenance, such as complex dosing, intensive monitoring, or clinical oversight?
S-3. Public Comment
HHSC reviews drugs meeting the rule criteria and publishes the resulting list as the draft SDL. HHSC welcomes comments from stakeholders using the Specialty Drug Submission Spreadsheet. Stakeholders have 15 business days from publication of the draft document to propose additions to or removals from the draft SDL:
- Requests received outside the 15-business-day review period are kept and reviewed during the following biannual review
- HHSC provides an initial acknowledgment and additional follow-up on whether the proposal was accepted or denied
A final SDL, incorporating approved public comment, is published biannually in March and Sept.
S-3.1. Submission Spreadsheet
Specialty Drug Submission Spreadsheet
HHSC requests the following information on the Contact tab of the submission spreadsheet:
- Date of submission
- Name of person submitting the request
- Name of organization
- Email address and contact phone number
- The calendar year and a month of the SDL recommendation
HHSC includes the specialty drug criteria as a reference.
The layout tab includes the fields required for submission on the Submit tab. HHSC requires the following information to consider your submission.
|A||NDC||11-digit national drug code number|
|B||Drug name||Name of product|
|K||Criteria #1 Justification||Stakeholder provides a detailed explanation of how NDC does or does not meet all of criteria #1|
|M||Criteria #3 Justification||Stakeholder provides a detailed explanation of how NDC does or does not meet all of criteria #3|
|N||Criteria #4 Justification||Stakeholder provides a detailed explanation of how NDC does or does not meet all of criteria #4|
|O||Final Recommendation Status||Stakeholder identifies one of the following selections:
HHSC requests the following information on the Submit tab of the submission spreadsheet:
- 11-digit national drug code number (column A)
- Name of product (column B)
- A detailed explanation of how the drug does or does not meet criteria #1 (column K), criteria #3 (column M), and criteria #4 (column N).
- Your justification should explain the drug’s complex education or treatment maintenance and list the name (and NPI, if known) of the pharmacies limited to dispensing the drug. Simply identifying a drug that meets or does not meet the criteria is insufficient, and HHSC will return submittals without adequate information.
- The stakeholder should identify the final recommendation status (column O) as either one of the two selections:
- Add: meets the three criteria
- Remove: does not meet at least one criteria
- Stakeholders should add new rows to the document as needed.
Stakeholders can manually enter drug information into this tab or copy a specific row from a published SDL.
Stakeholders should save a copy of the spreadsheet locally and ensure you complete all fields before sending the file to HHSC at email@example.com.
The dates below identify when events in the specialty drug list process occur.
|HHSC Work Begins||Draft Published for Public Comment||Final Published|
S-5. Revision History
|Revision||May 1, 2022||Consolidate subsections within section 3.1 (Submission Spreadsheet)|
|Baseline||Feb. 1, 2022||Initial publication|