CMS said in a response that it agrees it should strengthen its internal controls, but said it did not concur that it should collaborate with the FDA to create and maintain a comprehensive list of such drugs or regularly disseminate that list to drug plans. "Part D sponsors are aware of the requirement that ED drugs are excluded and our existing prescription drug event edits eliminate the need for an additional drug list," said a response from CMS' administrator Don Berwick, MD.
But the OIG said in its response to CMS that "Nothing in CMS's comments has caused us to change our findings or recommendations. As the administrator of the Medicare Part D program, CMS has the primary responsibility to ensure that sponsors are administering their Part D plans appropriately."
It added that "the edits in place during the period of review were not entirely successful in preventing CMS from accepting prescription drug event data for the ED drugs listed in Appendix A."
Other erectile dysfunction brand drugs listed in an OIG appendix A as being paid for by Medicare under Part D other than Viagra, but whose costs were questioned include Cialis tablets, Caverject impulse and Caverject sterile powder sterile powder compounds for injection, Levitra tablets and Muse suppositories, although the total mounts for those drugs was much less, just over $54,000.