700.003 HIV Medication Participating Site Eligibility Criteria

1.0 Purpose

To provide eligibility criteria for sites requesting to participate in the Texas HIV Medication Program (THMP).

THMP operates under the direction of the HIV/STD Section’s (Section) HIV Care and Medication Unit, in coordination with the Pharmacy Unit. THMP provides antiretrovirals and other medications to treat and prevent opportunistic infections that can occur in patients living with HIV. To ensure patients who have no means to pay for drug therapy receive the necessary medications, the MDAG establishes agreements with local participating sites. These agreements allow THMP to provide medications to those in need.
 

2.0 Authority

Title 45 Code of Federal Regulations (CFR) Parts 80, 81, 84, and 90; Title 22 Texas Administrative Code (TAC) §169.325 Authority of Physicians to Supply Drugs; TAC §98.107 THMP Benefits; 25 TAC §98.109 Nondiscrimination and Confidentiality; HIV/STD Section Policy 700.004 HIV Medications Ordering Process for Pharmacies.
 

3.0 Responsibilities

3.1 Texas Department of State Health Services (DSHS) Contracts Management Section (CMS)

• Executes a Memorandum of Understanding (MOU) with the participating site
• Sends the completed MOU to the participating site and the MDAG
• Contacts participating site to renew MOU
   

3.2 Associate Commissioner of the Infectious Disease Prevention Services Division

• Approves or denies the inclusion of the site to THMP
   

3.3 HIV Care and Medications Unit Director

• Reviews the denial requests and recommendations from the MDAG manager
• Reviews the appeals or questions regarding a denial
   

3.4 Medication Data and Analysis Group (MDAG)

• Serves as the first point of contact for participating sites. The Medication Orders Team Supervisor assists with completing requests. The pharmacy coordinator conducts outreach when there are not adequate participating sites.
• Reviews the site requests
• Evaluates the site’s eligibility
• Verifies the site information with Texas State Board of Pharmacy (TSBP)
• Establishes agreements with local participating sites
• Submits written recommendations to the MDAG Manager
• Provides written notifications to the site when denying participation in THMP
• Sends a welcome email to the participating site
• Approves the request and forwards it for required signatures to the Contract Management Section (CMS)
• Provides a written justification to the HIV Care and Medications Unit Director of the request to deny a site’s request to participate in THMP
• Verifies invoiced items on the Electronic Data Interface (EDI) are eligible expense fees
• Contacts participating site if the EDI includes ineligible expenses for correction
• Submits the correct EDI to the claims unit
   

3.5 Participating Site

• Licenses with TSBP
• Is a Medicaid Participating Site (except class C and D)
• Submits the request to MDAG
• Signs an MOU and renewal with DSHS
• Completes eligibility requirements as a participating site
• Renews MOU following the same steps in 5.0 How to Request to Become a Participating Site
   

3.6 Section Director

• Approves the requests and recommendation from the HIV Care and Medications Unit Director and forwards it to the Associate Commissioner of the Infectious Disease Prevention Division
   

3.7 THMP

• Provides antiretrovirals and other medications to treat and prevent opportunistic infections that can occur in patients living with HIV
• Notifies the MDAG to seek additional participating sites when they become aware of areas of the state without sufficient pharmacy coverage
• Receives and stages Dispense Fee Invoices from participating sites and submits it to the Medication Orders Team Supervisor
   

4.0 Eligibility Criteria

The Section requires each site to have a current license with the TSBP to distribute outpatient drugs. The Section requires participating sites (except Class C and D pharmacies) to be Medicaid-participating sites.

Eligible secondary sites must have the ability to receive, handle, and administer medicine under 22 TAC §169.3. A physician may personally administer drugs to their patients, which are, in the physician's medical judgment, therapeutically beneficial or necessary for the patient's treatment. A physician may delegate the authority to administer drugs to a qualified and properly trained person.
 

5.0 How to Request to Become a Participating Pharmacy

The MDAG considers the community’s needs and sites serving the public and excludes sites solely serving residential facilities such as nursing homes, hospitals, or state and federal residential facilities.

Sites requesting to participate in THMP may: 

• Visit THMP – Participating Pharmacy Information;
• Email Medication@dshs.texas.gov;
• Fax 512-989-4003; or
• Call 800-255-1090 during regular business hours. 

Requesting sites complete the Request to Become a THMP Participating Pharmacy form found on the THMP webpage and return it to the MDAG for processing and approval using one of the methods detailed on the form
 

5.1 Approval Process

The MDAG only reviews requests from sites meeting the eligibility criteria. The MDAG reviews each request and bases approval on need and the site’s TSBP disciplinary action history. The review process takes two to three months.

The MDAG verifies the submitted Request to Become a THMP Participating Pharmacy information with the TSBP. Upon a favorable report from the TSBP, the MDAG decides whether the addition of the site to THMP benefits THMP participants. The MDAG Manager authorizes the approval to participate in THMP.

If the MDAG Manager approves the request, they forward it to obtain the appropriate authorized signatures. DSHS does not execute an MOU until the Associate Commissioner of the Infectious Disease Prevention Division approves the request. Participation in the THMP becomes effective on the date of the last signature on the MOU. The DSHS Contracts Management Section sends the completed and signed MOU to the site, and the Medications Orders Team Supervisor sends a welcome email containing references and instructions to the site.

Participating sites may not request medications until participation in THMP becomes effective. Participating sites follow HIV/STD Section Policy 700.004 HIV Medications Ordering Process for Pharmacies when ordering medication from THMP.
 

5.2 Distribution Points for Chain Pharmacies

Participating sites that are part of a chain may request a central distribution point as a participating site location, from which the chain bears responsibility for distributing the medication. The ordering process is similar to HIV/STD Section Policy 700.004 HIV Medications Ordering Process for Pharmacies, except the central distribution point then takes responsibility for shipping the medications to their local sites and any additional shipping or replacement costs incurred when shipping the medications.

Those participating sites wishing to order using a central distribution point, ensure they deliver medications to clients within ten (10) days from the client’s request date. In addition, the participating sites are also responsible for keeping THMP required records and ensuring other site requirements are met.
 

5.3 Rebates

Participating sites are ineligible for drug manufacturer rebates for medications received through THMP.
 

5.4 Unfavorable Reports from the TSBP

When sites applying receive an unfavorable report from the TSBP, the MDAG denies their participation in THMP without further review. For sites with a central distribution point, this review applies to the distributing site.
 

5.5 Justification of Denial

The MDAG Manager provides written justification to the HIV Care and Medications Unit Director of the request to deny a site’s request to participate in THMP. The Unit Director reviews the justification and makes the final decision to approve or deny the request. Following the Unit Director’s review, the MDAG provides written notification to the site when denying participation in THMP.

The HIV Care and Medications Unit Director reviews appeals or questions regarding a denial. The decision of the Unit Director is final.
 

6.0 Program Requirements

• Participating sites sign an MOU with the Texas Department of State Health Services (DSHS).
• Participating sites sign renewal MOUs in accordance with the agreed-upon MOU effective dates.
• Only clients authorized by the MDAG are eligible to receive medications distributed through THMP.
• Participating sites only order medications directly from THMP. DSHS Central Pharmacy ships these medications.
• Participating sites must protect client confidentiality in accordance with applicable state and federal laws (25 TAC §98.109, Nondiscrimination and Confidentiality).
• Participating sites must maintain 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 THMP.
• Participating sites must afford access to any pertinent books, documents, papers, and records of a participating site 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.
• THMP, including participating sites, does 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 MDAG reserves the right to limit the number of clients assigned to a particular site at any given time. Participating sites may also contact the MDAG at any time to inform them the site has reached a capacity level for clients so the MDAG can institute a hold on that site’s roster.
• Participating sites may not collect dispensing fees from clients (see Texas HIV Medication Program Participating Pharmacy Guidelines). Participating sites invoice the MDAG directly each month for dispensed THMP medications, not to exceed $5.00 per medication. This includes Medicaid-eligible and non-eligible clients.
• THMP is the payor of last resort. THMP recipients must utilize all third-party payor sources before accessing medications from THMP. The site immediately notifies the MDAG if they become aware of a THMP recipient having third-party payor sources covering prescriptions. Additionally, the participating site must provide the requested client-level prescription and dispensing information required to retroactively bill third-party payer sources identified by the MDAG after the client receives THMP medications.
• DSHS only authorizes THMP to serve recipients residing in the state of Texas. The site must immediately notify the MDAG if they become aware of a THMP recipient residing outside the state of Texas. Participating sites may not forward program medications out of state or to another location. See Section 5.2 for exceptions for distribution point pharmacies.
• Program guidelines are available in the Texas HIV Medication Program Participating Pharmacy Guidelines.
   

7.0 Renewal of MOA

When renewing MOUs with participating sites, DSHS considers repeated and persistent complaints by clients about a site service or discriminatory practices. If a THMP recipient contacts DSHS with a complaint about a site, including the site’s discriminatory practices, the MDAG refers the client to the TSBP for appropriate disposition.
 

8.0 Termination

DSHS may terminate participation in THMP if the site’s standing with the TSBP changes to an unfavorable standing.

DSHS may terminate participation in THMP if funds allocated should become reduced, depleted, or unavailable during any agreement period and DSHS cannot obtain additional funds for such purposes. The MDAG immediately provides written notification to the site of such facts, and such agreement terminates upon receipt of the notification.

DSHS may terminate participation in THMP if there are changes in federal or state law or other requirements 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 MOU results in non-renewal or early termination of the MOU.
 

9.0 Revision History