U.S. Senators Thad Cochran and Roger Wicker, and Congressman Gregg Harper, all R-Miss, today renewed the call for the Center for Medicare and Medicaid Services (CMS) to rescind a proposed regulation that would disrupt the delivery of some chronic pain medications in Mississippi and other states.
The Mississippi lawmakers on Tuesday expressed their opinion that patients, physicians and pharmacies would be best served if CMS would retract Change Request 7397--a policy change unveiled on May 13 that would affect Medicare Part B reimbursement for patient-specific medications prepared by compounding pharmacies.
Originally set to go into effect on June 29 without a full notice or comment period, CMS late last week extended the implementation date to Jan. 1, 2012. This represents the third implementation delay issued by CMS since the change request was made.
"The Centers for Medicare and Medicaid Services should stop this effort once and for all. It has not provided a reasonable rationale for this regulatory change or explained how disrupting a system that now serves patients well will be improved by adding new federal guidelines. As we in Congress become more aware of federal over-regulation on American businesses and impediments to job creation, it does not make sense to go forward with this ill-considered policy change." Cochran said.
"Thousands of Americans depend on these innovative treatments, but CMS's proposed action threatens to end access to this care," said Wicker. "I am pleased that CMS has once again delayed implementation of the new rule. At a time when we need to be putting people back to work, regulations like this will only do the opposite. CMS should completely rescind this erroneous interpretation of a decades-old policy that has proven successful."
"While this delay is another victory for patients, CMS's decision is only temporary. I will continue to work with patient groups and health care providers to permanently halt this burdensome rule that restricts Medicare beneficiaries' access to compound pain medications," Harper said.
Alarm bells about the practical and legal ramifications of the CMS Medicare billing changes were set off by the Mississippi Pharmacists Association and compounding pharmacies that prepare patient-specific infusion pain medications. The proposed rule would change the way some pharmacies have been operating for decades by prohibiting them from directly billing Medicare for infusion pain medications used in implantable pumps. Instead, the change would require physicians to purchase the prepared medications from pharmacies and bill Medicare, placing new administrative and monetary burdens on physicians at a time when access to care for Medicare recipients is a national concern.
Harper, Cochran and Wicker brought stakeholders and CMS officials together on Capitol Hill in July to discuss the regulation and highlight potential problems with it. Questions were raised about the impact of the rule on patients, and whether proper protocol was used to develop the regulation.
Concerns have also been aired as to whether the changes conflict with Drug Enforcement Administration policies and some state policies barring the distribution or sale of pain medications to physicians for "resale" to patients. The Mississippi State Board of Pharmacy explicitly stated in a letter to CMS that this change would be in direct violation of Mississippi Pharmacy Law, under which Mississippi pharmacies are not allowed to sell compounded medications to anyone but the patient.
The Mississippi Pharmacists Association, as well as pharmacies like Advanced Infusion Solutions and VitalCare, have joined physicians, patients and pharmacies from across the nation in challenging the CMS change request.