In response, then Acting CMS Administrator Marilyn Tavenner wrote the OIG in May that the agency agreed with the first recommendation. "CMS is in the process of determining whether financial adjustments would be appropriate and/or legal given the absence of a list the government can provide to sponsors regarding which drugs are indeed LTE."
But she disagreed with the second OIG recommendation.
"We do not concur that it is our responsibility to publish this comprehensive, up-to-date list of the ...LTE (less-than-effective) drugs and their respective National Drug Codes (NDCs)..." she wrote. "We believe the FDA is in the best position to accomplish this and encourage the OIG to work with FDA in recommending mechanisms to disseminate comprehensive DESI lists to all stakeholders."
The OIG subsequently modified its recommendation saying that the FDA should have a role in identifying those ineffective drugs.
Tavenner added in her letter that "the lack of a complete and accurate listing of all marketed drug products and their NDCs are of ongoing concern to CMS and Part D sponsors since the inception of the Part D program."
The report said that $115 billion for prescription drugs was billed in Medicare Part D Medicare Advantage Plans for these two calendar years.