Pharmacy Affairs

Introduction to 340B Drug Pricing Program

The 340B Drug Pricing Program resulted from enactment of Public Law 102-585, the Veterans Health Care Act of 1992, which is codified as Section 340B of the Public Health Service Act. Section 340B limits the cost of covered outpatient drugs to certain federal grantees, federally-qualified health center look-alikes and qualified disproportionate share hospitals. Significant savings on pharmaceuticals may be seen by those entities that participate in this program.

The Pharmacy Services Support Center (PSSC) is a non-profit organization based at the American Pharmacists Association (APhA). This resource was established in 2002 through a contract with HRSA to assist eligible safety-net providers optimize the value of the 340B Program. The organization’s primary mission is to bring comprehensive pharmacy services to patients at 340B-eligible health care delivery sites to improve medication use and advance patient care. PSSC provides program guidance and free technical assistance to all 340B covered entities. To find out more, or to request technical assistance, visit the PSSC website or call 1-800-628-6297.

In addition to the cost savings available through the 340B Program, the 340B Prime Vendor Program (PVP) provides additional savings to 340B participants registered with the Prime Vendor. The PVP is managed by Apexus Inc.® (formerly HPPI) through a contract awarded by HRSA. The mission of the PVP is to improve access to affordable medications for all 340B covered entities. The program currently provides access to 340B sub-ceiling prices for over 2,800 drug products, access to multiple wholesale distributors at favorable rates, and access to other related value-added products. The PVP is free to all 340B covered entities, but the covered entity must enroll in the PVP. For more information, visit the PVP website or call 1-888-340-2787.

Organizations eligible for the 340B discount

(A) Federally-qualified health center (as defined in section 1905(l)(2)(B) of the Social Security Act). This category includes:

• FQHC Look-alikes
• Consolidated Health Centers (Sec.330(e) Public Health Service Act)
• Migrant Health Centers (Sec.330 (g) Public Health Service Act)
• Health Care for the Homeless (Sec.330(h) Public Health Service Act)
• Healthy Schools/Healthy Communities
• Health Centers for Residents of Public Housing (Sec. 330(i) Public Health Service Act)
• Office of Tribal Programs or urban Indian organizations (P.L. 93-638 and 25 USCS §1651)

(B) A family planning project receiving a grant or contract under Sec. 1001 PHSA (42 USCS§3001)

(C) An entity receiving a grant under subpart II of part C of Title XXVI of the Ryan White Care Act (RWCA) (relating to categorical grants for outpatient early intervention services for HIV disease) - Early HIV Intervention Services Categorical Grants (Title III of the RWCA)

(D) A State-operated AIDS Drug Assistance Program (ADAP) receiving financial assistance under the RWCA

(E) A black lung clinic receiving funds under Section 427(a) of the Black Lung Benefits Act (30 USCS§901)

(F) A comprehensive hemophilia diagnostic treatment center receiving a grant under section 501(a)(2) of the SSA

(G) A Native Hawaiian Health Center receiving funds under the Native Hawaiian Health Care Act of 1988 (42 USCS§11701)

(H) An urban Indian organization receiving funds under title V of the Indian Health Care Improvement Act (25 USCS§1601)

(I) Any entity receiving assistance under title XXVI of the Social Security Act (other than a State or unit of local government or an entity described in subparagraph (D)), but only if the entity is certified by the Secretary

(J) An entity receiving funds under section 318 (42 USCS §247c) (relating to treatment of sexually transmitted diseases) or section 317(j)(2) (42 USCS§247b(j)(2)) (relating to treatment of tuberculosis) through a State or unit of local government, but only if the entity is certified by the Secretary

(K) A disproportionate share hospital (as defined in section 1886(d)(1)(B)) of the SSA -

(i) is owned or operated by a unit of State or local government, is a public or private non-profit corporation which is formally granted governmental powers by a unit of State or local government, or is a private non-profit hospital which has a contract with a State or local government to provide health care services to low income individuals who are not entitled to benefits under title XVIII of the Social Security Act or eligible for assistance under the State plan under this title;
(ii) for the most recent cost reporting period that ended before the calendar quarter involved had a disproportionate share adjustment percentage (as determined under section 1886(d)(5)(F) of the Social Security Act) greater than 11.75 percent or was described in section 1886(d)(5)(F)(i)(II) of such Act; and
(iii) does not obtain covered outpatient drugs through a group purchasing organization or other group purchasing arrangement.

If your organization is an eligible program or DSH, you must submit a request to participate to the Office of Pharmacy Affairs (OPA) with your Medicaid billing information and the appropriate form:

• 340B Registration Form for entities other than Disproportionate Share Hospitals, FP, STD or TB entities (Acrobat/pdf)
• Disproportionate Share Hospitals
  • Disproportionate Share Hospital Flow Chart (Acrobat/pdf) Find out if your hospital may be eligible for the 340B Program
  • Disproportionate Share Hospitals & Adjustment Percentages (Excel)

    In accordance with CMS guidance, as of May 5, 2008, allowing hospitals to submit cost reports using either FY 2006 or FY 2005 SSI (Supplemental Security Income) ratios, the OPA is posting DSH List with two worksheets provided by CMS showing disproportionate share adjustment percentages using either fiscal year’s data. Please use the two tabs at the bottom of the spreadsheet to select the worksheet. Once 2007 SSI ratios are published and CMS provides this list to OPA, the OPA will return to posting one spreadsheet. More information is available at the CMS website.

  • Letter to Enroll In 340B Drug Pricing Program (for All Hospitals) (Acrobat/pdf) or as Text File
  • Certification Regarding Non-Participation in a Group Purchasing Organization (for All Hospitals) (Acrobat/pdf) or as Text File
  • Inclusion of Outpatient DSH Facilities (for All Hospitals) (Text File)
  • Additional Form for Private, Non-Profit Facilities
    Certification of a Contract between a Private Non-Profit Hospital and Local Government (Acrobat/pdf)
    
    
• Family Planning (Title X) Entities
  Clinics meeting the requirements for Family Planning (Title X) entity eligibility must apply for the 340B Drug Pricing Program through their grantee organization. Title V (State-funded) family planning clinics are NOT eligible for the 340B program. To register new FP sites a 340B Registration Form will need to be submitted.
  
  
• STD or TB Entities
  Clinics meeting the requirements for Sexually Transmitted Diseases and Tuberculosis entity eligibility must apply for the 340B Drug Pricing Program through their state program director. To register new STD or TB sites a 340B Registration Form will need to be submitted. New Online Registration Now Available for STD and TB Entities

Keep Covered Entity Information Up to Date

It is very important that OPA have information that is accurate and up to date, particularly the covered entity's exact name and street address. It is the responsibility of each covered entity to contact the OPA with any changes.

While the entity is eligible to participate in the program by virtue of its status, it must notify the OPA of its intention to participate by completing and submitting the appropriate registration form. Once the OPA receives this information, the entity will be eligible to receive pharmaceuticals at the 340B discounted price at the beginning of the next calendar quarter. The quarterly deadlines for data submission to OPA are December 1 for the quarter beginning January 1; March 1 for the quarter beginning April 1; June 1 for the quarter beginning July 1; and September 1 for the quarter beginning October 1. It is the entity's responsibility to tell its wholesaler or manufacturer that it is registered for 340B discount prices when it places an order.

If you have any questions regarding this program, please call the HRSA Pharmacy Services Support Center, 800-628-6297.