HRSA Office of Pharmacy Affairs Program Website

Law and Guidance

Section 340B of the Public Health Service Act

Selected Critical Guidance

  • NEW: Proposed OPPS Rule, 340B Excerpt (July 20, 2017)
  • NEW: OPA Withdrawal of Omnibus Guidance (Jan. 2017)
  • 340B Drug Pricing Program Omnibus Guidance Proposed Notice (2015)

Definition of a Patient

An individual is a “patient” of a covered entity (with the exception of State-operated or funded AIDS drug purchasing assistance programs) only if:

  1. the covered entity has established a relationship with the individual, such that the covered entity maintains records of the individual’s health care; and
  2. the individual receives health care services from a health care professional who is either employed by the covered entity or provides health care under contractual or other arrangements (e.g. referral for consultation) such that responsibility for the care provided remains with the covered entity; and
  3. the individual receives a health care service or range of services from the covered entity which is consistent with the service or range of services for which grant funding or Federally qualified health center look-alike status has been provided to the entity. Disproportionate share hospitals are exempt from this requirement.

An individual will not be considered a “patient” of the entity for purposes of 340B if the only health care service received by the individual from the covered entity is the dispensing of a drug or drugs for subsequent self-administration or administration in the home setting.

An individual registered in a State operated or funded AIDS drug purchasing assistance program receiving financial assistance under title XXVI of the PHS Act will be considered a “patient” of the covered entity for purposes of this definition if so registered as eligible by the State program.

  • Currently Effective Definition of Patient under the 340B Program (Notice Regarding Section 602 of the Veterans Health Care Act of 1992, Patient and Family Entity Eligibilty, 1996)
  • Current DSH Outpatient Hospital Facility Eligibility Requirements
    • Currently Effective Federal Register Notice (Notice Regarding Section 602 of the Veterans health Care Act of 1992, Outpatient Hospital Facilities, 1994)
    • OPA’s Implementation through Medicare Cost Report
  • See “Overview” and “Hospital Registration Review Process” drop down sections for an outline of specific medicare cost report and trial balance references
  • Guidance Permitting use of Multiple Contract Pharmacy Arrangements (Notice Regarding 340B Drug Pricing Program – Contract Pharmacy Services)
  • OPA Covered Entity Audit Guidance
    • OPA Website Guidance on Audit Process and Standards
    • 2013 Program Notice Clarification of HRSA Audits of 340B Covered Entities
    • Findings from 340B Program Audits of Covered Entities and Manufacturers

Federal Court Decisions Limiting the Scope of OPA’s Regulatory Authority

The federal District Court of the District of Columbia ruled that OPA’s authority to issue regulations implementing the 340B program is limited to the following areas where the court said the 340B statute gives the agency explicit regulatory authority – civil monetary penalties for manufactures, calculation of the 340B ceiling price, and administrative dispute resolution. These decisions influence the scope of the nature of OPA’s governance of the program, and the

  • DC District Court Decision Vacating HRSA’s Regulations Regarding Discounts on Orphan Drugs (Pharm. Research & Mfrs. of Am. v. U.S. De’t of Health & Human Servs., 43 F. Supp. 3d 28, 42-45 (D.D.C. 2014)
  • DC District Court Decision Vacating HRSA’s Subsequent Interpretive Rule Regarding Discounts on Orphan Drugs (Pharm. Research & Mfrs. of Am. v. U.S. De’t of Health & Human Servs., No. 14-1685-RC (D.D.C. Oct. 14, 2015)

Additional Guidance from OPA Contractor Apexus

OPA 340B Program Database (Access to Covered Entity and Contract Pharmacy Information and Registration, Medicaid Exclusion File, Orphan Drug File, etc.)

Medicaid Outpatient Drug Reimbursement for 340B Discounted Drugs

Changes in Medicare Reimbursement for Hospital-Based Outpatient Departments and Potential Implications for 340B Eligibility

  • Eyman Associates Policy Watch – Provider-Based Clinics in the Wake of Section 603: What You Need to Know About CMS’ Proposed Rule
  • CMS Medicaid Outpatient Hospital prospective Payment System 2017 Final Rule (Nov. 2016)Many questions remain regarding CMS implementation of hospital payments for provider-based departments and OPA’s implementation of those changes.
    “We note that, under our finalized policy, services provided at nonexcepted off-campus [provider based departments] PBDs will continue to be reported on the hospital cost report. We refer interested parties to HRSA for questions on when drugs qualify for discounts under the 340B program. To the extent that our final payment policies necessitate a change for hospital cost reporting, we will issue guidance, as applicable, in subregulatory guidance.” (Page 79718)

For full program guidance, see the HRSA OPA and Apexus websites