'Mega-guidance' proposal puts big limits on 340B Drug discounts
The proposal by the Health Resources and Services Administration addresses patient eligibility definitions, which affects thousands of hospitals.
New 'mega-guidance' for the 340B Drug Pricing Program would tighten eligibility requirements for hospitals and other participants in dispensing discounted drugs.
The proposal by the Health Resources and Services Administration addresses patient eligibility definitions, which affects thousands of hospitals getting the drug discount.
The Health Resources and Services Administration, which administers the 340B Drug Pricing Program, submitted the draft proposal amid concerns of a rising prescriptions and cost.
The draft proposal is now open for public comment.
[Also: 340B drug pricing debate pits hospitals against doctors against big pharma]
The 340B program requires drug manufacturers to give outpatient drugs to eligible healthcare organizations and covered entities at much reduced prices.
The Affordable Care Act expanded the types of covered entities eligible to participate.
As of Jan. 1, there were 11,530 registered covered entities and 644 drug manufacturers participating, according to the HRSA.
Nearly 40 percent of all U.S. hospitals participate in the 340B Drug Pricing Program, and the majority of the discounted drugs are sold to hospitals.
A July report by the Government Accountability Office found the program gives healthcare providers incentives to prescribe more drugs and more expensive drugs to treat Medicare Part B beneficiaries.
The report found per beneficiary Medicare Part B drug spending, including oncology drug spending, was substantially higher at 340B disproportionate share hospitals than at non-340B hospitals. The report stated there is little to counter any financial motive because the program does not restrict drug purchasing or limit reimbursement.
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The GAO recommended the financial incentives be slashed, but hospitals took issue with the report.
The Health Resources and Services Administration proposes restricting patients from eligibility in 340B if they are getting care from another provider. The rule also says discounted drugs could not be prescribed by a non-340B provider based on a referral from a 340B provider, and patients discharged from inpatient care would no longer be eligible for the discount that applies to outpatient care.
Twitter: @SusanMorseHFN
