New Year…Same Rules? HHS Makes Few Changes in Recent 340B Drug Pricing Program Final Rule
The Health Resources and Services Administration, part of the Department of Health and Human Services, published a Final Rule on January 5, 2017 addressing how 340B covered outpatient drug “Ceiling Prices” are to be calculated under the 340B Drug Pricing Program, and how participating drug manufacturers may be subject to certain monetary penalties for violation of the 340B statute (the Final Rule). The provisions of the Final Rule are effective March 6, 2017, and HHS indicated that it will begin enforcing the requirements of the Final Rule at the beginning of the second quarter of 2017, meaning April 1, 2017.
*This alert was originally posted on Arent Fox's Health Care Counsel blog. To read this alert in its entirety, please click here.