On September 26, 2012 The Department of Health and Human Services Office of Inspector General (OIG) issued a report on Schedule II drugs inappropriately billed to Medicare Part D. The report found that Medicare Part D inappropriately paid for $24.6 million in Schedule II drugs billed as refills, despite federal law prohibiting refills of Schedule II drugs.
Schedule II drugs are the second most controlled drugs under the Controlled Substances Act. They are classified as drugs which have a medical use, but have a high potential for abuse and may lead to severe psychological or physical dependence. Schedule II drugs with the highest number of refills billed to Medicare in 2009 include fentanyl, oxycodone-acetaminophen, morphine sulphate, and methadone HCI.
According to the report, 12,356 pharmacies billed for refills of Schedule II drugs, of which six percent were long-term-care pharmacies. Despite consisting of only six percent of the pharmacies that billed for refills of Schedule II drugs, long-term-care pharmacies were responsible for seventy-five percent of the refills. The report raises the possibility that some of these pharmacies actually incorrectly billed partial fills as refills. Partial fills are permitted for Schedule II drugs because of prohibitions on the amount a pharmacy can keep on hand at any one time. As a result, pharmacies will do partial fills of a prescription over a period of time, rather than filling the whole thing at once. In the CMS response to the report, CMS urged that it was likely that a majority of the refills were actually partial fills that were incorrectly billed. In turn, the OIG responded that even if that were the case it is still illegal to bill a refill of a Schedule II drug, regardless of the circumstances.
The OIG report further found that more than 25,000 refills of Schedule II drugs that were billed had invalid prescriber information. Prescriptions for Schedule II drugs require the name, address, and signature of the prescriber. Refills without proper prescriber information accounted for $1.4 million paid by Medicare Part D in 2009.
In 2009, the report concluded, 75% of all Medicare Part D sponsors paid for Schedule II drugs billed as refills, which indicates there are not appropriate safeguards in place to stop refills. The OIG made the following recommendations to CMS:
1. Issue guidance to sponsors to prevent billing of Schedule II refills and to ensure accurate billing of partial refills.
2. Exclude Schedule II refills when calculating payments to sponsors.
3. Monitor sponsors to ensure that they validate prescriber numbers for Schedule II drugs.
4. Follow up on sponsors and pharmacies with high numbers of refills of Schedule II drugs.
In response to these recommendations, CMS indicated that it will not work with sponsors and pharmacies to determine why there are not controls in place to prevent Schedule II refills. CMS will instead explore the use of PDE edits to prevent billing. CMS also did not agree to exclude Schedule II drugs billed as refills from payments to sponsors, and indicated that it will instead examine PDE edits to alert sponsors to inappropriate refills.
If you have questions about CMS drug billing edits, or need help creating a billing compliance plan, please contact an experienced Wachler & Associates healthcare attorney at 248-544-0888.