This part implements section 340B of the Public Health Service Act (PHSA) “Limitation on Prices of Drugs Purchased by Covered Entities.”

Section 340B of the PHSA instructs the Secretary of Health and Human Services to enter into agreements with manufacturers of covered outpatient drugs under which the amount to be paid to manufacturers by certain statutorily-defined covered entities does not exceed the 340B ceiling price.

For the purposes of this part, the following definitions apply:

340B Administrative Dispute Resolution (ADR) process means a process used to resolve the following types of claims, including any issues that assist the 340B ADR Panel in resolving such claims:

(1) Claims by covered entities that may have been overcharged for covered outpatient drugs purchased from manufacturers; and

(2) Claims by manufacturers of 340B drugs, after a manufacturer has conducted an audit of a covered entity (pursuant to section 340B(a)(5)(C) of the Public Health Service Act (PHS Act)), that a covered entity may have violated the prohibitions against duplicate discounts or diversion.

Administrative Dispute Resolution Panel (340B ADR Panel) means a decision-making body within the Health Resources and Services Administration's Office of Pharmacy Affairs that reviews and makes decisions for claims filed through the 340B ADR process.

Average Manufacturer Price (AMP) has the meaning set forth in section 1927(k)(1) of the Social Security Act, as implemented in 42 CFR 447.504.

Ceiling price means the maximum statutory price established under section 340B(a)(1) of the PHSA and this section.

Claim means a written allegation filed by or on behalf of a covered entity or by a manufacturer for resolution under the 340B ADR process.

CMS is the Centers for Medicare & Medicaid Services.

Consolidated claim means a claim resulting from combining multiple manufacturers' claims against the same covered entity.

Covered entity means an entity that is listed within section 340B(a)(4) of the PHSA, meets the requirements under section 340B(a)(5) of the PHSA, and is registered and listed in the 340B database.

Covered outpatient drug has the meaning set forth in section 1927(k) of the Social Security Act.

Joint claim means a claim resulting from combining multiple covered entities' claims (or claims from their membership organizations or associations) against the same manufacturer for the same drug or drugs.

Manufacturer has the meaning set forth in section 1927(k) of the Social Security Act, as implemented in 42 CFR 447.502.

National Drug Code (NDC) has the meaning set forth in 42 CFR 447.502.

Office of Pharmacy Affairs (OPA) means the office, or any successor office assigned to administer the 340B Program, within the Health Resources and Services Administration, or any successor agency, that oversees the 340B Program.

Pharmaceutical Pricing Agreement (PPA) means an agreement described in section 340B(a)(1) of the PHSA.

Quarter refers to a calendar quarter unless otherwise specified.

Secretary means the Secretary of the Department of Health and Human Services and any other officer of employee of the Department of Health and Human Services to whom the authority involved has been delegated.