On September 27, 2016, the Health Resources and Services Administration (HRSA) sent an email announcement that it will extend its quarterly registration period for the 340B Drug Pricing Program (340B Program) by two days (from October 1-15 to October 1-17). Noting that this quarter’s registration period would both begin and end on a Saturday, HRSA announced that it was extending the registration deadline to Monday, October 17, 2016, to give potential covered entities an additional business day to register. This extension may be of particular benefit to urban hospitals that have sought Rural Referral Center (RRC) status under CMS’s new policy, discussed here, and are waiting for a response from CMS. RRCs can qualify for 340B discounts with a Medicare Disproportionate Share Hospital adjustment percentage of just 8.25% instead of the greater than 11.75% threshold that applies to urban DSHs.
The 340B Program, administered by HRSA, enables safety net hospitals and other selected provider categories to purchase outpatient drugs from manufacturers at significantly reduced prices. Providers eligible to participate in the program are defined by the 340B statute (42 U.S.C. § 256b), and are limited to nonprofit health care organizations that have certain federal designations or receive funding from specific federal programs. Examples include Medicare/Medicaid DSHs, RRCs, Children’s Hospitals, federally Qualified Health Centers, Ryan White HIV/AIDS Program grantees and other safety net providers.
To purchase discounted outpatient drugs under the 340B Program, eligible organizations, known as covered entities, must register for the 340B Program during one of the four enrollment periods throughout the year, which occur on the first 15 days of each calendar quarter (i.e., January 1-15, April 1-15, July 1-15, October 1-15). Successful applicants may participate in the program on the first day of the next quarter following approval.
HRSA’s alert extending the 340B Program registration deadline to October 17, 2016, can be found here. Learn more about the 340B Program and registration requirements here.
