PHARMACY

Feds’ new view of multisource drugs draws opposition from NACDS, NCPA

BY Jim Frederick

ALEXANDRIA, Va. The National Association of Chain Drug Stores and the National Community Pharmacists Association today asked the Centers for Medicare and Medicaid Services to withdraw a new and potentially damaging definition of “multiple source drug,” a definition both pharmacy groups say could scramble the prescription payment system for Medicaid and cut further into reimbursements to pharmacies.

The revised definition comes in the form of an interim final rule adopted by CMS. In comments submitted to CMS today, NACDS president and chief executive officer Steve Anderson and NCPA executive vice president Bruce Roberts called attention to two critical legal concerns with the new way the Bush administration is defining multisourced medications.

“The first concern is that the rule was not subject to the normal notice and comment rulemaking process in accordance with the Administrative Procedure Act, which requires public notice and a comment period prior to most rule changes,” the two leaders noted.

The second sticking point is more serious. Anderson and Roberts said the definition of multiple source drugs “is critical for pharmacies because CMS uses Federal Upper Limits (FULs) to cap Medicaid reimbursement to pharmacies that dispense them.”

That said, they told CMS, “the Social Security Act provides that a drug is not a multiple source drug unless two or more equivalent drug products are ‘sold or marketed in the State;’ that is, whether particular drug products are generally available to the public through retail pharmacies in each state. CMS did not comply with this standard in revising the rule.

“While we appreciate CMS’ efforts to redefine ‘multiple source drug’, it is critical that the revisions meet all guidelines and compliance requirements,” said Anderson and Roberts. “Pharmacies are at risk of improper and inadequate Medicaid reimbursements due to the AMP [average manufacturer’s price] rule [for multi-sourced drugs] and the revised definition. As a result, those who will suffer the greatest burden will be the patients and the states.”

The full comments are posted here.

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PHARMACY

FDA announces safety review of two immunosuppressive drugs

BY Drew Buono

WASHINGTON The Food and Drug Administration issued an early communication today stating that an ongoing safety review is taking place about the immunosuppressive medications CellCept by Roche and Myfortic by Novartis.

The drugs have been linked in safety data provided by Roche to progressive multifocal leukoencephalopathy, a sometimes fatal disorder that affects the central nervous system.

Roche has recommended including this information in the CellCept label. The active ingredient in CellCept, mycophenolate mofetil, is metabolized by the body to MPA (mycophenolic acid), the active drug ingredient in Myfortic.

The FDA anticipates taking two months to complete its review of the safety data and the proposed revised labeling for CellCept and Myfortic that includes information about PML.

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MyInsuranceExpert.com launches in nine states

BY Drew Buono

BLOOMFIELD HILLS, Mich. A new Web site called MyInsuranceExpert.com helps individuals and families research and purchase insurance policies, according to published reports.

MyInsuranceExpert.com is available in Michigan and eight other states and hopes to expand to 40 states by the end of 2009. So far, he said the site’s biggest business comes from states like Texas and Florida, where there are fewer companies offering insurance to employees.

People go to the site to receive online quotes and ultimately purchase their insurance policy. But the site also has personal, licensed advisers who work with each client to ensure they have the most cost-effective policy possible.

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