Breaking news: Pharmacies fight for right to continue billing CMS directly for intrathecal pain solutions

Opponents of a controversial Change Request initiated by the Centers for Medicare and Medicaid Services (CMS) aired their views to CMS officials earlier this week.

Pharmacy associations, pain-drug infusion pharmacies, and legislators met with CMS officials in Washington, D.C., to express their concerns about CMS Change Request 7397. The Change Request will reassert a longstanding rule that prohibits pharmacies from billing Medicare Part B directly for intrathecal pain solution delivered by infusion pumps to treat chronic pain. Under the Change Request, physicians will have to bill Medicare for the medications and then reimburse pharmacies.

However, many pharmacists have been billing Medicare directly for pain-pump solutions for years and have received reimbursement from Medicare. In addition, opponents say, the Change Request was published without public notice and a comment period. As a result, pharmacy associations, the National Home Infusion Association, and several other groups recently obtained a 45-day delay of the start date for the rule change. Now, CMS is expected to make a final decision on the rule by August 15.

“Prohibiting pharmacies from billing Medicare directly for these medications, as has been longstanding practice, will disrupt service to patients and create new possibilities for drug diversions,” wrote U.S. Representative Gregg Harper (R-MS) in a June 28 letter to CMS Administrator Donald Berwick. Representatives from Harper’s office attended the CMS meeting.

The Mississippi Pharmacists Association, Advanced Infusion Solutions, home-infusion-services company Vital Care Inc., and other companies urged CMS to let pharmacies bill Medicare directly for pain infusion solutions.

“The Change Request would reduce patient access to pain-management therapy options by creating a chaotic environment with conflicting regulations. The Change Request instructs pharmacies to sell compounded intrathecal preparations to physicians even though the DEA [Drug Enforcement Administration] does not allow pharmacies to sell these preparations to physicians in most cases,” said Eugene O’Donnell, executive director of the Mississippi Pharmacists Association.

In addition to violating DEA law, the Change Request would require pharmacies to resell compounded medications, which most state laws do not allow, according to testimony given at the CMS meeting by Chuck Bell, CEO and president of Advanced Infusion Solutions in Clinton, Miss.. “We talked to numerous state boards of pharmacy, and most states say it is against the law for a patient-specific compounded medication to be resold,” he told Drug Topics.

Instead of pushing through the Change Request quickly, CMS needs to align its policy with DEA rules, O’Donnell said. O’Donnell hopes that CMS officials will allow specialty pharmacies in Mississippi and across the country to bill Medicare directly, as they have been doing for approximately 20 years. “We always want the pharmacist to be able to direct bill for a service. It is a good thing,” O’Donnell said.

A proponent of the CMS Change Request, specialty pharmacy AnazeoHealth in Tampa, Fla., attended the CMS meeting but declined to comment for this article.