700.003 HIV/STD Medication Pharmacy Eligibility Criteria
|Effective Date||June 27, 1997|
|Revision Date||January 31, 2018|
|Approval Authority||HIV/STD Prevention and Care Branch Manager|
To provide eligibility criteria for pharmacies requesting to participate in the Texas HIV Medication Program (THMP).
25 TAC §98.113 Participating Pharmacy; HIV/STD Policy No. 700.004; 25 TAC §98.111 Confidentiality.
The TB/HIV/STD Section, under its authority, requires that participating pharmacies be Medicaid providers.
The Texas HIV Medication Program (THMP) established in 1987 operates under the direction of the HIV/STD Prevention and Care Branch in the TB/HIV/STD Section. The THMP provides antiretrovirals and other medications to treat and prevent opportunistic infections that can occur in patients infected with HIV. In order to carry out its function of providing medications to patients who would otherwise have no means to pay for drug therapy, it is necessary for the THMP to identify and enter into agreements with local pharmacies.
4.0 Eligibility Criteria
Each pharmacy must have a current license with the State Board of Pharmacy to distribute outpatient drugs. All but Class C and D pharmacies are required to be Medicaid participating pharmacies.
5.0 How to Request to Become a Participating Pharmacy
5.1 Request to Become a Participating Pharmacy
Pharmacies requesting to participate on the THMP may either go to the THMP webpage at dshs.texas.gov/hivstd/meds/document.shtm or call 1-800-255-1090 during regular business hours. Requesting pharmacies will need to fill out the Memorandum of Agreement (MOA) found on the THMP webpage and return to the Program for processing and approval through the mail.
5.2 Approval Process
Only pharmacies meeting the eligibility criteria will be reviewed. The THMP will review each request on a case-by-case basis. The review process takes approximately two to three months.
When the THMP receives the pharmacy’s filled out MOA, the information given by the pharmacy will be verified with the State Board of Pharmacy. Upon a favorable report from the State Board of Pharmacy, the THMP will make a determination as to whether the addition of the pharmacy to the Program will benefit the THMP and/or client(s). The THMP will consider the community’s need, pharmacies that serve the general public and will exclude pharmacies that solely serve residential facilities such as nursing homes, hospitals, and/or state and federal residential facilities. Approval to participate in the THMP is authorized by the THMP Manager or his/her designee.
When the THMP Manager approves the MOA, the MOA is forwarded to obtain the appropriate authorized signatures. The MOA is not executed until the signature of the Assistant Commissioner of the Disease Control and Prevention Services Division is obtained. Participation in the THMP will become effective on the date of the last signature on the MOA. When all authorized signatures are obtained on the MOA, the THMP will send an approval letter with a copy of the signed MOA to the pharmacy.
Pharmacies may not request any medications until participation in the THMP becomes effective. Participating pharmacies must follow HIV/STD Policy No. 700.004 when ordering medication from the THMP.
5.3 Distribution Points for Chain Pharmacies
Pharmacies that are part of a chain may request a central distribution point as a participating pharmacy location, from which the chain will bear responsibility for distributing the medication. The ordering process is similar to that described in Policy 700.004, HIV Medications Ordering Process for Pharmacies, except that the central distribution point then takes responsibility for shipping the medications to their local pharmacies and any additional shipping or replacement costs incurred when shipping the medications.
Those pharmacies wishing to order using a central distribution point, are also required to ensure the medications are delivered to clients within ten (10) days from the client’s request date. In addition, the pharmacies are also responsible for keeping all program required records and ensure that all other pharmacy requirements are also met.
Pharmacies participating and receiving medications through this program are NOT eligible to file for drug manufacturer rebates for those medications.
5.5 Unfavorable Reports from the State Board of Pharmacy
Pharmacies that apply and receive an unfavorable report from the State Board of Pharmacy will be denied participation in the Program without further review. For pharmacies with a central distribution point, this review will apply to the distributing pharmacy.
5.6 Justification of Denial
The THMP Manager will provide written justification to the HIV/STD Prevention and Care Branch Manager (Branch Manager) of the decision to deny a pharmacy’s request to participate in the Program. The Branch Manager will review the justification and make the final decision to approve or deny the request. Following the Branch Manager’s review, the THMP will provide written notification to the pharmacy when denied participation in the THMP.
Appeals or questions regarding a denial will be forwarded to the Branch Manager for review. The decision of the Branch Manager is final.
6.0 Program Requirements
All participating pharmacies must sign a MOA with the Texas Department of State Health Services (DSHS). Renewal MOA’s must also be signed in accordance with agreed upon MOA effective dates.
Only clients authorized by the THMP are eligible to receive medications distributed through the THMP.
Medications must be ordered directly from the THMP and will be shipped from the DSHS pharmacy warehouse.
Client confidentiality must be protected in accordance with all applicable state and federal laws (25 TAC §98.111 Confidentiality).
Participating pharmacies are to maintain all client records and supporting documents, including statistical records, in accordance with state law and for a period of three years after termination of participating status from the THMP.
Access to any pertinent books, documents, papers, and records of a participating pharmacy must be afforded to DSHS, the US Department of Health and Human Services (DHHS), the Comptroller General of the United States, or any of their duly authorized representatives for the purpose of performing an audit, examination, excerpts, and transcriptions of transactions.
The THMP, including participating pharmacies, will not discriminate against (applicant or eligible) clients on the grounds of race, creed, color, handicap, age, ability to pay, sex, or national origin (45 CFR Parts 80, 81, 84, and 90).
The THMP reserves the right to limit the number of clients assigned to a particular pharmacy at any given time. Pharmacies may also contact the THMP at any time to inform the THMP that the Pharmacy has reached a capacity level for clients so that a hold may be instituted on that Pharmacy’s roster.
Pharmacies will no longer collect dispensing fees from clients (see Texas HIV Medication Program Participating Pharmacy Guidelines). Pharmacies will invoice the THMP directly each month for dispensed THMP medications, not to exceed $5.00 per medication. This includes Medicaid eligible and non-eligible clients.
The THMP program is considered the payor of last resort. Program recipients must utilize all third party payor sources before accessing medications from the THMP. The Pharmacy must immediately notify the THMP if they become aware of a program recipient having third party payor sources that covers prescriptions.
The THMP is only authorized to serve recipients residing in the state of Texas. The Pharmacy must immediately notify the THMP if they become aware of a program recipient residing outside the state of Texas. Pharmacies may not forward program medications out of state or to another location unless it’s a distribution point pharmacy (see section 5.3 of this policy)
Additional guidelines can be found in Texas HIV Medication Program Participating Pharmacy Guidelines located at: dshs.texas.gov/hivstd/meds/document.shtm.
7.0 Renewal of MOA
Repeated and persistent complaints by clients about a pharmacy service and/or discriminatory practices will be considered during the renewal phase of the MOA process. If a program recipient calls the THMP with a complaint about a pharmacy including a pharmacy’s discriminatory practices, the THMP will refer the client to the State Board of Pharmacy for appropriate disposition.
Participation in the THMP may be terminated if the pharmacy’s standing with the State Board of Pharmacy changes to an unfavorable standing.
Participation in the THMP may be terminated if funds allocated should become reduced, depleted, or unavailable during any agreement period, and DSHS is unable to obtain additional funds for such purposes. The THMP will immediately provide written notification to the pharmacy of such fact, and such agreement will be terminated upon receipt of that notification.
Participation in the THMP may be terminated in the event that federal or state law or other requirements should be amended or judicially interpreted so as to render continued fulfillment of this agreement, on the part of either party, unreasonable or impossible.
Failure to follow program requirements or adhere to the MOA will result in non-renewal or early termination of the MOA.
9.0 Revision History
|1/31/2018||Changed section 6.0 (ninth bullet) to reflect that clients will no longer be charged a dispensing fee. Pharmacies will bill THMP for dispensing fees.||6.0|
|9/1/2017||Changed "TB/HIV/STD Unit" to "TB/HIV/STD Section" to reflect new program designation||-|
|1/9/2017||Addition of new sections 5.3 and 5.4 to address shipment of medications to a central source when dealing with chain pharmacies. Other minor revisions to remaining sections to reflect addition of sections 5.3 and 5.4.||5.3 and 5.4|
|4/1/2015||Revisions reflect new titles and procedures.||All|
|10/7/2014||Converted format (Word to HTML)||-|
|Created standalone version of form 700.001A||10.0|
|11/13/2002||Converted format (WordPerfect to Word)||-|