August 16, 2012—The Office of Pharmacy Affairs (OPA) plans to begin recertifying federally qualified health centers (FQHCs) enrolled in the 340B program in January, with the first notification emails being sent to centers’ authorizing officials in November, OPA announced this week.
During an Aug. 14 webinar, OPA Director Cmdr. Krista Pedley also said that 340B stakeholders will be seeing new patient definition guidance “in the near future.”[ms-protect-content id=”2799”] Pedley was responding to a participant’s question and did not elaborate. In mid July, two influential members of the House Energy and Commerce Subcommittee on Health called on the Health Resources and Services Administration (HRSA) to issue an updated definition “that ensures the program’s eligibility is for those truly in need.”
Also during the webinar, Pedley said that policy releases on the 340B Medicaid exclusion file and 340B eligibility requirements for hospitals are “in the works” and that an FAQ on the amount of time that covered entities must retain 340B documents might be forthcoming.
In addition, a slide shown during OPA’s presentation indicates that the office is changing one of the attestations of program compliance that covered entities must sign when recertifying their eligibility for the drug discounts. An entity would now have to swear that it “meets” all 340B eligibility requirements, rather than swear that it has “continuously met” all requirements since it began participating in 340B.
The webinar was geared toward community health centers, which will be the last major 340B covered entity group to go through the recertification process. OPA has already recertified hospitals, Title X clinics, Ryan White AIDS programs, and sexually transmitted disease and tuberculosis clinics.
Cmdr. James Morris, OPA’s operations branch chief, said health centers’ 340B authorizing officials will get a preliminary email about recertification in November, followed by a second in December explaining the process in more detail, and then finally a third in January with the username and password they will need to complete the process online.
Morris urged centers not to wait until January to check the accuracy of their information in OPA’s covered entity database and ask for changes to be made if necessary. Beginning tomorrow, Aug. 17, FQHCs and all other 340B providers will need to use a new online tool instead of paper forms to get such changes made. Morris also told the centers that their information in the OPA database needs to match the information in their HRSA Electronic Handbook (EHB), the online tool that grantees use to manage their HRSA grant portfolios.
Morris also described OPA’s new deadlines for initial enrollment in 340B. Beginning in October, providers will be able to enroll themselves, their outpatient sites, and their contract pharmacies only during four, 15-day windows per year: Oct. 1-15, Jan. 1-15, April 1-15, and July 1-15. Applications submitted outside of those four periods will not be accepted, he said.
OPA announced separately this week that it is holding a webinar on the new enrollment deadlines next Thursday, Aug. 23, from 2 p.m. to 3 p.m. See the OPA home page for more information.
Morris also reminded health centers taking part in the webinar that the recently issued A-133 audit compliance supplement, available in full on the Office of Management and Budget Web site, now includes questions about 340B program compliance. All non-federal entities that spend $500,000 or more in federal awards per year must have an annual program audit. Beginning in fiscal year 2013, HRSA grantee site visits also will include 340B compliance questions, he said.
Pedley, meanwhile, reminded health centers that they are subject to being selected by HRSA for a more in-depth compliance audit or being audited by a drug manufacturer if it can establish reasonable cause to believe that there has been a program violation.
Health centers were among the 51 covered entities audited by HRSA this year, Pedley noted. She said OPA was “hopeful that we can get through the audit findings in the next few months” and publish the results on its Web site.[/ms-protect-content]