Final 340B Mega-Guidance Takes a Step Toward Release

by Admin | September 7, 2016 7:11 am

September 2, 2016—The Health Resources and Services Administration has sent its final 340B program omnibus guidance to the White House Office of Management and Budget for review prior to publication in the Federal Register.

HRSA transmitted the final mega-guidance to OMB on Sept. 1, according to an entry on an OMB website[1]. OMB reviews all federal agency rules prior to their publication in the Federal Register. These reviews should take no more than 90 days. There is no minimum period. OMB can extend the review on a one-time basis for no more than 30 days and HRSA can extend it indefinitely. When the review is complete, OMB can clear the mega-guidance for publication or send it back to HRSA for further consideration.

If OMB’s review moves at its normal pace and if OMB doesn’t ask HRSA to make major changes, the mega-guidance could be released around late November or early December. There’s no guarantee events will unfold this way, however. The final mega-guidance could come out sooner. It could be delayed indefinitely.

HRSA released its proposed 340B mega-guidance in late August 2015 and comments were due by Oct. 27, 2015. The guidance covers a host of 340B matters from patient eligibility to use of the discounts in offsite clinics. 340B Health, the association of hospitals and health systems in the drug discount program, noted in its comments[2] that the proposed guidance, particularly its proposed patient definition, “will have an extremely adverse impact on hospitals’ 340B programs and their efforts to meet the needs of their underserved patients.”

The hospital group noted that the mega-guidance would establish problematic new policies, including:

• No 340B discounts for prescriptions given to patients upon discharge from inpatient stays from the hospital, even though such prescriptions play a significant role in reducing readmissions
• No 340B discounts for infusion administered to many hospital outpatients
• No 340B discounts for outpatient drugs furnished to patients that are ultimately admitted to the hospital
• No 340B discounts for outpatient drugs given to hospital patients unless the hospital bills for the prescriber’s professional services, a practice most hospitals cannot do
• No 340B discounts for many drugs paid by Medicaid, even though the 340B program is intended for hospitals that treat high percentages of Medicaid patients
• No 340B for referrals for follow-up care of hospital patients

HRSA’s final draft of the mega-guidance is confidential. HRSA received over a thousand comments, almost two-thirds of which came from hospitals. HRSA also received comments from the drug industry that recommended narrowing the use of 340B even further than what HRSA had proposed.  How and to what degree HRSA has changed the guidance is unknown.

Source URL: https://340binformed.org/2016/09/final-340b-mega-guidance-takes-a-step-toward-release/

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