WASHINGTON -- Despite a rule that bars Medicare reimbursement for erectile dysfunction (ED) treatments, the Centers for Medicare and Medicaid Services (CMS) paid out $3.1 million for the drugs in 2007 and 2008, a new government report found.
Of the $3.1 million, $3 million went toward paying for (sildenafil) Viagra, according to the report prepared by the Department of Health and Human Services Office of the Inspector General.
The congressional ban went into effect in 2007.
"... Part D should not have covered these drugs," concluded the report.
Other FDA-approved drugs to treat ED include tadalafil (Cialis), vardenafil (Levitra), and alprostadil injections (Caverject) and suppositories (Muse), but those prescriptions accounted for just a fraction of the total cost CMS spent on treating ED in 2007 and 2008.
The Medicare Modernization Act of 2007 stated that CMS wouldn't pay for "... a drug when used for the treatment of sexual or erectile dysfunction, unless such drug were used to treat a condition, other than sexual or erectile dysfunction, for which the drug has been approved by the Food and Drug Administration."
CMS will still pay for ED drugs to treat other conditions for which they are FDA-approved, such as pulmonary hypertension.
The ED prescriptions were erroneously paid for because CMS' Medicare Drug Data Processing System didn't have an updated list of excluded drugs, so it automatically approved the reimbursements for ED drugs prescribed for sexual or erectile dysfunction, the report said.
The government contracts with private insurers to administer Medicare Part D, the drug benefit, which is offered to those who are entitled to Medicare Part A or enrolled in Part B.
The report authors recommended that CMS determine whether it can try to get the money back from the insurance companies that were paid by Medicare for providing ED drugs.
The report also recommended:
- Strengthening internal controls to make sure that only drugs explicitly covered by Medicare Part D are reimbursed
- That CMS work with the FDA to maintain a comprehensive list of drugs that are FDA-approved for ED treatment -- and should not be covered for that purpose
- Regularly disseminate that list to insurance companies that administer Medicare Advantage plans
In addition, CMS should update its computer program to automatically reject claims for ED drugs, the report authors wrote.
CMS officials concurred with the report's recommendation that CMS try to recoup some of the money paid for ED drugs.
In a letter to Daniel Levinson, Inspector General, CMS Administrator Donald Berwick, MD, said CMS will determine whether it's "appropriate and cost effective" to reopen final payment decisions for 2007 and 2008 in order to "recover the costs of claims for drugs used for the treatment of sexual or erectile dysfunction paid in those years."
However, Berwick did not agree that they should join forces with FDA to maintain a comprehensive list of approved ED drugs and regularly disseminate that list to insurers, according to the report.
CMS said it has updated its computer program on a weekly basis since 2009 to reject nonapproved drugs, and that insurers who administer Part D benefits know ED drugs are not covered to treat sexual problems.