December 15, 2015—The White House Office of Management and Budget has finished reviewing the so-called Medicaid average manufacturer price (AMP) final rule, potentially clearing the way for its publication before the end of the year. [ms-protect-content id=”2799″]
OMB wrapped up its review of the Centers for Medicare & Medicaid Services regulation on Dec. 11, according to a notation on the OMB website. The designation “consistent with change” means the rule was revised during the review and that OMB is satisfied with it. Once OMB concludes a review as “consistent,” the issuing agency can publish it. The agency, however, is under no deadline to publish its rule and may even withdraw it.
The final rule is expected to have a significant impact on the 340B program, including areas related to covered outpatient drugs, best price, the average manufacturer price, and Medicaid reimbursement for 340B. It could raise 340B discounts for some drugs and lower them for others.
In general, the 340B ceiling price is the lower of either a manufacturer’s best price or
- for brand name drugs, AMP minus 23.1 percent
- for generic drugs, AMP minus 13 percent
- for hemophilia and pediatric drugs, AMP minus 17.1 percent
Health care providers are entitled to an additional 340B discount if a brand-name drug’s AMP has risen faster than the rate of inflation. Congress passed legislation last month that will subject generic drugs to the same inflation penalty beginning in 2017.
The final rule will also clarify the separate AMP that the Affordable Care Act created for inhalation, infusion, instilled, implanted, or injectable drugs (“5i drugs”). [/ms-protect-content]