340B Recertification Includes Strong Compliance Pledge

by admin | May 2, 2012 9:48 am

May 2, 2012—A new program-integrity oath that hospitals must take to remain certified for 340B drug discounts has “the strongest language” about compliance that they have ever been asked to sign, the Office of Pharmacy Affairs (OPA) official leading its hospital recertification initiative[1] said last week during a webinar for drug manufacturers and wholesalers.

“This is very strong language,” said Lt. Cmdr. Joshua Hardin during the April 26 event.[ms-protect-content id=”2799″] “It reiterates the program requirements for transparency, accountability, and integrity and verifies that [hospitals] understand the potential consequences of not meeting the program requirements.”

OPA held two webinars for hospitals about the recertification initiative on Feb. 28[2] and March 28[3] but in neither did it list for hospital officials the new attestations they would need to sign.

During the April 26 webinar, Hardin read the list of stipulations aloud. Hospital senior executives, he said, will be required to attest that:

• all information listed on the 340B program database for that covered entity is complete, accurate, and correct
• the hospital has continuously met all 340B program eligibility requirements since being listed as being eligible on the 340B database
• the hospital complies with all 340B requirements and restrictions and any accompanying regulations or guidelines including, but not limited to, the prohibition against duplicate discounts/rebates under Medicaid and the prohibition against transferring drugs purchased under 340B to anyone other than a patient of the entity
• the hospital maintains auditable records demonstrating their compliance with the requirements described in (3) above
• the hospital has systems/mechanisms in place to reasonably ensure ongoing compliance with the requirements described in (3) above
• if the hospital uses contract pharmacy services, this contract pharmacy arrangement is performed in accordance with OPA requirements and guidelines including, but not limited to, the hospital obtains sufficient information from the contractor to ensure compliance with the applicable policy and legal requirements and the hospital has utilized an appropriate methodology to ensure compliance (e.g. through an independent auditor or other mechanism)
• the hospital acknowledges the responsibility to contact OPA as soon as reasonably possible if there is any material breach by the hospital of any of the foregoing
• if the hospital does not notify OPA in a timely fashion, it acknowledges it may be required to remit payment back to manufacturers which would represent the difference between the 340B discounted price and the drug’s non-340B purchase price.

Hospitals and other 340B providers have always been obliged “to ensure the accuracy of their information in the database and that they’re in compliance with 340B requirements,” said OPA Director Krista Pedley. But now “they’re actually attesting to that” and those with inaccurate information or that fail to comply “will be removed from the program,” she emphasized.

“This is very important to us and we are taking it very seriously,” Pedley said.

At present, there is only one known publicly accessible sample of the attestations and it appears to be incomplete. A version appears in a 340B recertification “user guide” on the OPA Web site[4], in an example of a recertification Web page. Although the guide is on the OPA Web site, it was not referenced in any of the three OPA webinars. It also is not mentioned in either the OPA[5] or Pharmacy Services Support Center (PSSC)[6] frequently-asked questions about recertification.

The guide itself indicates that OPA was to have directed covered entities to it in the emails they received notifying them about the recertification requirement. However, a copy of one of those email notifications that a hospital received contains no mention of the guide.

Pharmacies as Ship-To Sites

Several webinar participants asked Pedley to address why OPA is requiring hospitals to decertify pharmacies as child sites and re-list them as “ship-to” sites of either their parent hospital or one or more of its outpatient facilities. From their questions, it appears that manufacturers and distributors don’t fully know what to make of the high number of such de-listings that occurred in the weeks leading up the start of the recertification initiative in mid-April[7].

Pedley stated that OPA’s policy against pharmacies being listed as child sites “is nothing new” and their re-listing as ship-to sites is “actually accurate and what should be occurring.”

“It doesn’t mean that they were wrongly buying drugs, it was more about how they were listed in our database,” she said. “We now want to correct that moving forward.” Pedley urged hospitals, manufacturers, and wholesalers to cooperate “to ensure that if a pharmacy is removed as a child site and then listed as a ship-to, that the site is purchasing under the appropriate 340B ID and not under the ID that has been removed.”

In response to questions, Pedley and Hardin also told the webinar participants:

• Manufacturers and wholesalers should direct their questions about hospital recertification to the Apexus/340B Prime Vendor “Apexus Answers”[8] service, rather than to the Pharmacy Services Support Center (PSSC)[9].
• Hospital outpatient facilities for which 340B enrollment has been sought but that have not yet appeared on a filed Medicare cost report cannot purchase drugs through a group purchasing arrangement.
• It is up to covered entities to make sure their address information in the 340B database is complete, including room or suite numbers.
• If a hospital or an outpatient site is terminated, it should stop seeking 340B discounts as of the effective date of its termination, rather than on the last day of the quarter in which it is terminated.
• OPA will probably issue an FAQ on how covered entities should eliminate their 340B stocks if they are decertified.
• OPA plans to make a recording of the webinar available shortly, according to a notice on its home page[10].[/ms-protect-content]

Source URL: https://340bemployed.org/340b-recertification-includes-strong-compliance-pledge/

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