On September 20, 2010, the Health Resources and Services Administration (HRSA) released two Advanced Notices of Proposed Rule Making (ANPRMs) related to provisions of the Accountable Care Act (ACA) affecting the 340B drug discount program. The 340B program allows certain hospitals and federally funded clinics (known as “covered entities”) to obtain covered outpatient drugs at substantially discounted prices. Section 7102 of the ACA requires that HRSA promulgate regulations regarding an administrative dispute resolution (ADR) process and a manufacturer civil monetary penalty (CMP) process. The ANPRMs allow HRSA to seek public comment prior to issuing proposed regulations addressing each of these new processes. By submitting comments in response to these ANPRMs, covered entities and manufacturers have an opportunity to provide feedback to HRSA on the development of the ADR and CMP processes prior to the issuance of the proposed rules.
In the ANPRM for the ADR process, HRSA specifically requests comments on the following 12 issues:
- Administrative procedures associated with ADR
- Existing models for ADR that could be adapted to the 340B program
- Threshold requirements demonstrating good faith attempts to settle disputes before involving HRSA
- Structure of ADR hearings
- Whether the decision-making official or body should be comprised of individuals from HRSA, the Office of Pharmacy Affairs, or other parts of the Department of Health and Human Services
- Appropriate appeals procedures
- Timeframes for bringing a claim
- Discovery procedures
- Applicability of current manufacturer audit guidelines to the ADR process
- Consolidation of multiple claims against a single covered entity or manufacturer
- Third-party claims
- Integration of an ADR process with other 340B oversight mechanisms
In the ANPRM for the manufacturer CMPs, HRSA specifically requests comments on the following nine issues:
- Existing models for CMPs that could be adapted to the 340B program
- When CMPs should be applied
- Administrative processes for administering CMPs that are best suited to the 340B program
- Structure of CMP hearings
- Establishment of an appeals process
- Definitions of key terms necessary for the administration of CMPs
- Computation of CMPs
- Mechanisms for payment of CMPs and pursuit of civil action for non-payment
- Integration of CMPs with other 340B oversight mechanisms Comments under both ANPRMs are due to HRSA by November 19, 2010.
A copy of the ADR ANPRM is available here. Comments on the ADR ANPRM may be submitted to firstname.lastname@example.org.
A copy of the CMP ANPRM is available here. Comments on the CMP ANPRM may be submitted to email@example.com.
The ANPRMs are the most recent issuances in a series of regulations and guidances that HRSA is expected to release to implement changes to the 340B program resulting from the ACA. Previously, HRSA held a webinar to provide guidance to entities that became newly eligible for the 340B program under the ACA and released a FAQ regarding eligibility for retroactive rebates. A recording of the webinar, held July 28, 2010, is available here, summaries of the eligibility requirements for newly eligible entities are available here and registration forms for newly eligible entities are available here. FAQ regarding retroactive rebates is available here. A future release is expected regarding the orphan drug exclusion, but HRSA has not provided information regarding when such guidance may be released.