Title 42

SECTION 10.21

10.21 Claims.

§ 10.21 Claims.

(a) Initiating an action. Any covered entity or manufacturer may initiate an action for monetary damages or equitable relief against a manufacturer or covered entity, as the case may be, by filing a written petition for relief with HRSA and mailing a copy of the petition with any attachments to the General Counsel or other senior official of the opposing party at its principal place of business by certified mail, return receipt requested, within three days of filing the claim. The petition should satisfy the pleading requirements of Rules 8, 10, and 11 of the Federal Rules of Civil Procedure, including setting forth the factual basis for invoking the 340B ADR Panel's jurisdiction. A claim must include all of the requirements in paragraph (d) of this section. Additional information to substantiate a claim may be submitted.

(b) 340B ADR Panel's jurisdiction. The 340B ADR Panel shall have jurisdiction to entertain any petition where the damages sought exceed $25,000 or where the equitable relief sought will likely have a value of more than $25,000 during the twelve-month period after the 340B ADR Panel's final agency decision, provided the petition asserts claims of the type set forth below.

(1) Claims by a covered entity that it has been overcharged by a manufacturer for a covered outpatient drug, including claims that a manufacturer has limited the covered entity's ability to purchase covered outpatient drugs at or below the 340B ceiling price; and

(2) Claims by a manufacturer, after it has conducted an audit of a covered entity pursuant to section 340B(a)(5)(C) of the PHSA, that the covered entity has violated section 340B(a)(5)(A) of the PHSA regarding the duplicate discount prohibition, or section 340B(a)(5)(B) of the PHSA regarding the diversion prohibition, including claims that an individual does not qualify as a patient for 340B Program purposes and claims that a covered entity is not eligible for the 340B Program.

(d) Limitation of actions. (1) A covered entity or manufacturer must file a written claim for administrative dispute resolution with HRSA within 3 years of the date of the alleged violation. Any file, document, or record associated with the claim that is the subject of the ADR process must be maintained by the covered entity and manufacturer until the final agency decision is issued by the 340B ADR Panel.

(2) Notwithstanding Rules 8 and 10 of the Federal Rules of Civil Procedure, a covered entity filing a claim described in paragraph (c)(1) of this section must provide documents sufficient to demonstrate its claim that it has been overcharged by a manufacturer, along with any such other documentation as may be requested by the 340B ADR Panel.

(3) Notwithstanding Rules 8 and 10 of the Federal Rules of Civil Procedure, a manufacturer filing a claim under paragraph (c)(2) of this section must provide documents sufficient to demonstrate its claim that a covered entity has violated the prohibition on diversion or duplicate discount, along with any such documentation as may be requested by the 340B ADR Panel.

(e) Combining claims. (1) Two or more covered entities may jointly file claims of overcharges by the same manufacturer for the same drug or drugs if each covered entity that could file a claim against the manufacturer consents to the jointly filed claim, including submission of the required documentation, described in paragraph (d) of this section.

(2) An association or organization may file claims of overcharges by the same manufacturer for the same drug or drugs on behalf of multiple covered entities if each covered entity represented could file a claim against the manufacturer, is a member of the association or organization, meets the requirements described in paragraph (d) of this section, including submission of the required documentation, and each covered entity has agreed to representation by the association or organization on its behalf.

(3) A manufacturer or manufacturers may request to consolidate claims brought by more than one manufacturer against the same covered entity if each manufacturer could individually file a claim against the covered entity, consents to the filing of the consolidated claim, meets the requirements described in paragraph (d) of this section for that claim, and the 340B ADR Panel determines that such consolidation is appropriate and consistent with the goals of fairness and economy of sources. The 340B ADR Panel will not permit consolidated claims filed on behalf of manufacturers by associations or organizations representing their interests.

(4) Joinder, consolidation, and other third-party practice not referenced in this paragraph (e) shall be governed by the Federal Rules of Civil Procedure, as relevant, unless the parties and 340B ADR Panel agree otherwise.

(f) Responding to a submitted claim. Upon receipt of service of petition, the respondent must file with the 340B ADR Panel a written response to the Petition as set forth in Rule 12 or 56. The 340B ADR Panel may issue additional instructions as may be necessary or desirable governing the conduct of ADR proceedings, including instructions pertaining to deadlines for submission of additional information. If an opposing party does not respond to the petition, the 340B ADR Panel may enter a final agency decision by default in favor of the Petitioner. In a proceeding for damages, the Petitioner must still introduce evidence sufficient to support its claim for damages even though the merits have been resolved through default.