Breaking news: CMS decision to delay rules change for infusion pump solutions lauded by pharmacy groups and legislators

June 30, 2011

Professional pharmacy organizations and U.S. Congressional leaders lauded the decision announced today by the Centers for Medicare and Medicaid Services (CMS) to delay the agency's change in Medicare billing rules governing infusion pump solutions for pain medications.

Professional pharmacy organizations and U.S. Congressional leaders lauded the decision announced today by the Centers for Medicare and Medicaid Services (CMS) to delay the agency’s change in Medicare billing rules governing infusion pump solutions for pain medications.

Slated to take effect June 29, CMS's Change Request 7397 prohibits pharmacies from billing Medicare for implantable, intrathecal, pain pump solutions for chronic pain care. This change, which would reverse a 20-year policy, would mean that pump solutions would have to be prepared in physicians' offices.

However, after pressure from a group of Congressional representatives and pharmacy organizations such as the Arkansas Pharmacists Association (APA), CMS agreed to a 45-day delay to review the Change Request.

“We applaud the CMS in doing that. We think it is important that they understand the issues, including the concern that there are people inside physicians’ offices who may decide to start preparing solutions in their offices,” said Scott Pace, PharmD, JD, associate executive vice president of APA.

One of the chief concerns of APA and other groups such as the National Home Infusion Association (NHIA) is that the Change Request violates Drug Enforcement Administration (DEA) rules. “The DEA has a rule preventing pharmacies from dispensing to anyone other than the end user. It would be impossible for pharmacists to deliver it to physicians’ offices, since they are not the end users - patients are,” Pace said.

"Quite frankly, it makes no sense. Prohibiting pharmacies from billing Medicare directly for these medications, as has been long-standing practice, will disrupt service to patients and create new possibilities for drug diversions," wrote Congressman Gregg Harper (R-MS) in a June 28 letter to Dr. Donald Berwick, CMS administrator.

Despite CMS’s delay, members of Congress and pharmacy association officials recognize that they have a lot of work ahead of them over the next 45 days. “Although I consider CMS’ decision a small victory for patients, this is only temporary. I will continue to work with patient groups and healthcare providers to craft a longer-term solution to permanently halt this policy,” Rep. Harper told Drug Topics.

Both Congressional representatives and state pharmacy associations are working to get the message to Congress and CMS that Change Request 7397 is “not only contrary to other agency regulations, but also impedes patient access to critical care,” said Ned Milenkovich, PharmD, JD, a member at the law firm McDonald Hopkins and a legal columnist for Drug Topics.