Last Call for Comments on the Bipartisan Discussion Draft of the SUSTAIN Act: Shaping 340B for the Future

Sense of Congress

Codifies that the purpose of the 340B Program is to stretch scarce resources and help safety net providers maintain, improve, and expand patient access to health care services by requiring drug manufacturers—as a condition of participation in Medicaid and Medicare—to provide discounts and rebates to covered entities that serve a disproportionate share of low-income and underserved patients

Contract Pharmacy

• Clarifies that contract pharmacies can in fact be used by covered entities, in accordance with the Health Resources and Services Administration’s (HRSA’s) 2010 guidance
• Adds a new statutory section on contract pharmacies that requires manufacturers to:
  • Offer covered entities the 340B price for an outpatient drug regardless of whether the drug is dispensed through a pharmacy under contract with a covered entity or directly by the covered entity;
  • Deliver or allow the delivery of covered outpatient drugs purchased by a covered entity and their associated sites (at or below the applicable ceiling price) to pharmacy locations, as requested by the covered entity, in accordance with the covered entity’s contract pharmacy agreements;
  • Not place conditions on the ability of a covered entity to purchase drugs at the 340B price, including a drug that is dispensed at a contract pharmacy location (restricting distribution options, etc.)
• Requires covered entities to:
  • Annually register their contract pharmacy sites with the U.S. Department of Health and Human Services (“HHS”);
  • Submit all contract pharmacy arrangements in a timely manner;
  • Register each contract pharmacy arrangement specifying the parent, child, or associated sites prior to implementing the contract pharmacy arrangement, and
  • Attest to each contract pharmacy arrangement’s compliance with the requirements under this section

FEEDBACK SOUGHT: The Working Group seeks comment on:

• The definition of a “patient,” and how the definition should reflect the evolution of the 340B program; the factors that should inform whether the covered entity has a meaningful relationship with a patient; the elements that should be considered for determining discounts for patients served by multiple entities; among other elements
• How to achieve the correct balance of patient access accountability and program integrity in contract pharmacy arrangements
• Additional limitations on the use of contract pharmacies—supported with data-based suggestions and reasoning – including the consideration of differences in how urban and rural hospitals utilize contract pharmacy arrangements
• Structuring geographic or other restrictions on contract pharmacies to ensure that patients in rural and underserved areas maintain access to drugs
• Structuring limitations on contract pharmacies to ensure patients have access to specialty medications
• Policies to allow covered entities to contract with pharmacies to ensure patients have access to 340B drugs, without additional requirements or limitations
• Policies to limit the influence of pharmacy benefit managers (PBMs) in the Program while ensuring that Program financial benefits remain with covered entities and eligible patients

Child Sites

• Amends the statute to include a section on child sites and specifies that child sites must be wholly owned by and financially integrated into the covered entity
• Enumerates a number of requirements relating to registration, financial and other operations, reporting, procedures, and recordkeeping

FEEDBACK SOUGHT: The Working Group seeks additional feedback on how to appropriately ensure that child sites are aligned with the intent of the 340B program (including appropriate guidelines, additional requirements, level of oversight, specific policies, program integrity measures, special considerations in geographic areas).

Transparency

Requires covered entities to report detailed information regarding policies, patient and prescription information—which would be publicly available—as well as certain specific data (including the use of savings in the 340B program, the number of individuals given drugs at the 340B price, the total number of prescriptions filled with covered outpatient drugs, the financial demographics of patients, and the covered entity’s list of contract pharmacies)

Enhancing Program Integrity

• Authorizes the Secretary of HHS (the “Secretary”) to perform audits on covered entities, child sites, contract pharmacies, and manufacturers under the statute
• Requires covered entities to only contract with vendors who agree to submit data to the Secretary and independent outside auditors, among others
• Imposes additional sanctions for violations of the statute

Preventing Duplicate Discounts

Creates a national, third-party drug discount program data clearinghouse to prevent duplicate discounts between 340B and Medicaid

Ensuring Equitable Treatment of Covered Entities and Participating Pharmacies

Imposes new requirements, exclusions, reimbursement terms, and prohibits a number of specific actions to ensure group health plans, health insurance issuers, or PBMs do not discriminate against covered entities, their contract pharmacies, or their participants, beneficiaries, or enrollees

User Fee Program

Adopts a user fee program to equip HRSA with the appropriate resources to oversee and administer the 340B Program

Studies and Reports

• Requires the Medicaid and CHIP Payment and Access Commission (MACPAC) to submit a report to Congress on the efforts of state Medicaid agencies to prevent duplicate discounts
• Requires HHS to conduct a study on dispensing fees

Additional Resources for Oversight

Authorizes an additional $3,000,000 for HHS to conduct 340B Program audits, investigations, oversight, and enforcement activities

Definitions

Defines key terms throughout the text