Breaking news: Legislators, pharmacies work to halt CMS rule on pain medications for infusion pumps by June 29

Legislators and pharmacists are working to convince the Centers for Medicare and Medicaid Services (CMS) to halt its rule change on infusion pump solutions for pain medications. CMS's Change Request 7397 will prohibit pharmacies from billing Medicare for implantable, intrathecal, pain pump solutions for chronic pain care. Instead, CMS plans to reverse its 20-year policy, which would mean the pump solutions would have to be prepared in physicians' offices.

U.S. Congressmen and lawyers for pharmacists say they do not understand why the CMS rule change was made, and are working to delay or halt the change by its implementation date, June 29, 2011.

"If we don't stop it in the next 24 hours, it is going to be the new method of operation," said Ned Milenkovich, PharmD, a partner at the law firm McDonald Hopkins in Chicago, Ill, and a legal columnist for Drug Topics. The rule change alters the structure of Medicare Part B reimbursements and legally requires a public notice and comment period by the CMS, Milenkovich added.

"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.

The National Home Infusion Association (NHIA) is asking CMS for a 45-day delay on the rule change because many of its members are confused about CMS officials' rationale for making a change and several issues need to be resolved. "We are concerned that a number of our members who may be affected by this policy were not in contact with CMS and were not aware of the conversations you have had with several pharmacies," wrote Russell Bodoff, CEO and president of the NHIA, in a recent letter to Marc Hartstein, deputy director of CMS's Hospital and Ambulatory Policy Group.

One of the major sticking points in the rule change is the fact that the high-risk compound pain management solutions must be prepared by pharmacists, according to Harper and Milenkovich. "No physician's office is going to deal with preparing this in a nonsterile environment," Milenkovich said.

The NHIA, legislators, and others, also believe the rule change will result in an increase in illegal diversion of prescription pain medications.

"Doing this will unfortunately propagate drug diversion. Pharmacies must be involved in the handling of controlled substances, in order for there to be a checks and balance system," Milenkovich said.

Many of the pain medications involved are considered controlled substances by the Drug Enforcement Administration, which prohibits pharmacies from dispensing or selling these substances to physicians for "resale" to patients. "If pharmacies cannot bill Medicare, and physicians cannot resell or dispense these drugs to patients, patient access to these critical drugs will be severely restricted," Harper wrote.