Taxpayers paid more than $3.1 million in 2007 and 2008 for sexual or erectile dysfunction drugs such as Viagra that should not have been reimbursed under federal rules for Part D, according to a report Monday from the Office of Inspector General.
Since Jan. 1, 2007, Centers for Medicare and Medicaid Services rules prohibit the use of such drugs to treat sexual or erectile dysfunction, although they may be used for other indications approved by the U.S. Food and Drug Administration. One such approved use approved for some of these drugs, for example, is pulmonary hypertension.
"Of approximately $133 billion in gross drug costs included in (Medicare Advantage plans and private prescription drug plans prescriptions) for calendar years 2007 and 2008, CMS accepted (prescriptions) ...totaling $3,107,200 in gross drug costs for ED drugs approved only for the treatment of sexual or erectile dysfunction. Pursuant to Federal requirements, Part D should not have covered these drugs," the OIG report said.
"For example, (Part D) sponsors submitted records totaling $3,021,475 in gross drug costs for the drug Viagra.... FDA had not approved Viagra for the treatment of any condition other than sexual or erectile dysfunction at the time of our audit."
The OIG recommended that CMS determine if it can adjust payments for such drugs when they were used for erectile or sexual dysfunction. It also recommended that CMS strengthen its internal controls and collaborate with the FDA to keep a comprehensive list of such drugs, disseminate the list to drug plans and periodically update the software program to reject payment when the drugs are prescribed just for erectile dysfunction.
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.