The Federal Government has announced its plans for moving up the effective date of the regulation that would impose civil monetary penalties to manufacturers that “knowingly and intentionally” overcharge hospitals for their 340B drugs. The change was announced in a proposed rule that the U.S. Department of Health and Human Services (HHS) unveiled Friday, November 2nd.
The law (made in 2010) was to be effective on July 1, 2019. It is now being purposed to activate on January 1, 2019, six months prior than the original date. This law, along with imposing civil monetary penalties to manufacturers who overcharge their drugs, there will be set regulations on pricing to be published so healthcare providers can confirm they are being charged correctly.
“We are encouraged that, in response to our lawsuit, the government has proposed to begin enforcing rules demanding transparency and accountability for pharmaceutical manufacturers participating in 340B,” said 340B Health Interim President and CEO Maureen Testoni. “In response to our legal challenge, HHS is now proposing to begin enforcement of the rule on Jan. 1. This would protect 340B providers from overcharges that sap them of their ability to care for patients in need. Now HHS must ensure that date does not slip.”
340B needs our help in submitting comments to HHS on civil monetary penalties and 340B ceiling prices to ensure real transparency for manufacturers of 340B drugs. Click HERE to have your voices heard in this crucial effort.