Healthcare Providers Comment on 340B Program Proposed Rule

by admin | August 21, 2015 10:07 am

[1]August 21, 2015—The Health Resources and Services Administration should clarify in a forthcoming 340B program rule that drugmakers must give refunds for all overcharges on 340B drugs above a reasonable dollar amount and within a reasonable amount of time after their discovery, including those due to routine average manufacturer price “true-ups,” groups representing healthcare providers urged in a public filing this week. They said HRSA also should clarify that providers are not required to request such refunds or credits. [ms-protect-content id=”2799″]

The groups were commenting on HRSA’s proposed rule setting standards for calculating 340B ceiling prices and implementing civil monetary penalties for manufacturers that knowingly and intentionally overcharge for 340B drugs. HRSA released the draft rule in June[2] and comments were due Aug. 17. Drug manufacturers, state Medicaid directors, wholesalers, and other stakeholders also submitted comments and the Monitor will report on these separately.

In their joint comments, the 340B provider groups asked HRSA to define “overcharging” for purposes of calculating fines against manufacturers on a per-unit rather than per-order basis, and to use part of revenue from the fines to support HRSA’s Office of Pharmacy Affairs, the 340B ceiling price database[3] that OPA is creating, and the Department of Health and Human Services Office of Inspector General’s 340B enforcement activities.

Eight associations representing providers participating in 340B made the joint submission[4] to HRSA: National Association of Community Health Centers, The Hemophilia Alliance, Planned Parenthood Federation of America, Inc., National Health Care for the Homeless Council, America’s Essential Hospitals, Children’s Hospital Association, Ryan White Clinics for 340B Access, and 340B Health.

The three hospital group among them – America’s Essential Hospitals, Children’s Hospital Association, and 340B Health – submitted a separate set of joint comments[5] to HRSA. In those comments, they urged the agency to say expressly in the rule’s definition of “covered outpatient drug” that the Medicaid drug rebate program’s limiting definition does not apply to the 340B program. “Some manufacturers have misconstrued the limiting definition and have sought to use it improperly to remove drugs from 340B pricing,” the groups said. “These manufacturers take the position that the limiting definition restricts 340B pricing to those drugs that are separately paid by the payer (e.g., private insurers, Medicare, or Medicaid). This is an unreasonable interpretation that, in addition to being inconsistent with the statute and legislative history, would dramatically restrict safety net providers’ access to 340B pricing.”

HRSA should likewise remove the limiting definition from the rule’s definition of “340B drug,” the hospital groups said.

The broader group of providers also made these comments:

• HRSA should ensure that no changes are made that could impede or hamper federal grantees’ ability to negotiate sub-340B or non-340B prices with manufacturers individually, or collectively through group purchasing organizations.
• HRSA should clarify that a drug purchased at or below the ceiling price is a 340B drug only when the price is required by a pharmaceutical pricing agreement and that drugs which are discounted outside the 340B program are not included within the definition of “340B drug,” even when sold at or below the ceiling price.
• HRSA should state its statutory authority to issue regulations governing 340B ceiling price calculations.
• The 340B organizations support HRSA’s 340B ceiling price formula and efforts to develop a 340B ceiling price database but recommends that HRSA clarify the definition of “case package size.”
• The 340B organizations support HRSA’s codification of the penny pricing policy.
• The 340B organizations generally support HRSA’s codification of the new drug pricing policy with technical clarifications.
• The 340B organizations support HRSA’s proposal to assess CMPs according to OIG procedures, but request that HRSA clarify that key definitions from OIG regulations will be incorporated into the 340B CMP program. Specifically, a manufacturer should be subject to CMPs based on the manufacturer’s actual knowledge, deliberate ignorance, or reckless disregard of an overpayment.
• HRSA should clarify that the obligation of a manufacturer to ensure the availability of 340B pricing applies to a covered entity’s contract pharmacy arrangement with a specialty pharmacy in a manufacturer’s limited distribution network for a particular drug.
• HRSA should require manufacturers to honor a covered entity’s request to reclassify a purchase from non-340B to 340B and to issue a corresponding refund if a covered entity requests such a reclassification within one year of purchase.

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Source URL: https://340bemployed.org/healthcare-providers-comment-on-340b-program-proposed-rule/

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