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Sept. 6 — Final guidance intended to provide more clarity for drugmakers and safety-net providers participating in the federal 340B drug discount program is moving closer to release.
The White House Office of Management and Budget started its review Sept. 1 of the final guidance document (RIN:0906-AB08 ), according to the OMB's reginfo.gov website. The Department of Health and Human Services released the proposed version of what it calls the omnibus guidance document in August 2015 (13 PLIR 1249, 8/28/15). The 340B program helps safety-net providers obtain discounted drugs.
The guidance would define who is considered a patient for purposes of the 340B program. The guidance also covers drug company responsibilities, such as procedures for issuing credits and refunds. Other subjects covered in the guidance are the HHS's audit of a covered entity, the HHS's audit of a manufacturer and a manufacturer's audit of a covered entity.
The drug industry generally supports the guidance because it says more clarity is needed for the 340B program, particularly for the definition of patient. However, safety-net providers have concerns with the guidance because they say it could limit their ability to serve the poor by putting additional restrictions on drug discounts.
The Health Resources and Services Administration (HRSA), the part of the HHS that administers the program, said in August 2015 that it was “proposing this omnibus guidance to provide increased clarity in the marketplace for all 340B Program stakeholders and strengthen HHS’s ability to administer the 340B Program effectively.”
340B Health, a group that represents health-care providers receiving discounts in the program, said in a Sept. 2 statement provided to Bloomberg BNA that it is “very concerned about key aspects of the proposed mega-guidance which could have a devastating impact on safety-net hospitals' ability to serve the poor.”
“Almost two-thirds of the comments received by HRSA [on the proposed guidance] were from hospitals and we are hopeful that the agency has taken their position into account,” 340B Health said. “In addition, research shows that although 340B DSH [disproportionate share hospital] hospitals only account for about one third of all hospitals, they provide nearly 60 percent of all uncompensated care. They also provide twice as much care to poor patients, patients of color and the disabled.”
340B Health also said “rural hospitals are already struggling to survive and any additional restrictions on accessing pharmaceutical discounts would be a major blow to them and their patients.”
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The proposed version of the omnibus guidance document is at http://op.bna.com.s3.amazonaws.com/hl.nsf/r%3FOpen%3dbbrk-9zsjjy.
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