More Details Emerge on 340B Audit of Drug Manufacturer

by admin | February 12, 2015 4:53 pm

February 12, 2015—More information about the first 340B program audit of a drug manufacturer emerged today during a drug industry government pricing conference in Washington.[ms-protect-content id=”2799″]

Speaking at the Government Drug Pricing Forum in Washington, Ann Maxwell of the Department of Health and Human Services Office of Inspector General revealed that auditors are looking both at the manufacturer’s 340B ceiling prices and also at whether the manufacturer’s allocation procedures treat 340B covered entities equitably. That last bit of information could signal that the manufacturer being audited sells a product that experiences supply issues.

OIG is conducting the audit in conjunction with the Health Resources and Services Administration. Ms. Maxwell said OIG will issue its findings directly to HRSA and will not make them public “unless HRSA opts to do so.” HRSA Office of Pharmacy Affairs Director Cmdr. Krista Pedley also spoke at the event and said in response to a question that HRSA “probably” would publish a summary of the audit findings, in the same fashion as its summaries of covered entity audit findings.

Repeating information she first disclosed at the 340B Coalition winter meeting last week[1], Cmdr. Pedley said HRSA hopes to share information about the audit findings “soon.” She also repeated that HRSA is developing a protocol for conducting audits of manufacturers and plans to begin more such audits in fiscal year 2015.

Other Highlights

Other highlights from the first day of the industry meeting include:

OIG is auditing 340B covered entities to collect information about the difference between what providers pay for 340B drugs and what the Medicare Part D program reimburses them for such drugs. Ms. Maxwell said the audit was “descriptive” in nature and is similar to OIG’s separate study of 340B’s impact on Medicare Part B spending[2].

Pedley said HRSA will publish a second notice in the Federal Register soon seeking comment on its plans to collect data from drug manufacturers to verify their 340B ceiling prices. There will be a 30-day comment period, she said. The first notice[3], published on Sept. 30, 2014, had a 60-day comment period.

Drug manufacturer Daiichi Sankyo and health care data analysis firm IMS Health are collaborating on a 340B contract pharmacy claim identification project. In part, it will examine to what degree contract pharmacy arrangements cause Daiichi to provide 340B discounts to covered entities and to pay commercial rebates to pharmacy benefit managers on the same drugs.[/ms-protect-content]

Endnotes:

the 340B Coalition winter meeting last week: http://340binformed.associationbreeze.com/2015/02/340b-omnibus-guidance-slated-for-june-release/
Medicare Part B spending: http://340binformed.associationbreeze.com/2015/01/whats-in-store-for-340b-in-2015-part-4/
The first notice: http://340binformed.associationbreeze.com/2014/09/opa-to-collect-340b-ceiling-price-information/

Source URL: https://340bemployed.org/more-details-emerge-on-340b-audit-of-drug-manufacturer/