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
HHSC publishes a final SDL, incorporating approved public comment, biannually in March and Sept.
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.