Pharmacy operators and drug wholesalers say they fear that a new Centers for Medicare and Medicaid Services (CMS) policy could prevent certain medications for chronic conditions from being covered by Medicare Part D.


Centers for Medicare and Medicaid Services, CMS, National Drug Code, NDC, Medicare Part D, pharmacy, drug wholesalers, National Association of Chain Drug Stores, NACDS, Healthcare Distribution Management Association, National Community Pharmacists Association, Charlene Frizzera, American Pharmacists Association, Food Marketing Institute, Food and Drug Administration, FDA, John Schultz


















































































































































































































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CMS policy on Part D is at issue

December 7th, 2009

WASHINGTON – Pharmacy operators and drug wholesalers say they fear that a new Centers for Medicare and Medicaid Services (CMS) policy could prevent certain medications for chronic conditions from being covered by Medicare Part D.

To minimize disruption on senior citizens and pharmacies, five pharmacy associations — including the National Association of Chain Drug Stores, the Healthcare Distribution Management Association and the National Community Pharmacists Association — have proposed a series of potential remedies for the problem.

In a letter to CMS acting administrator Charlene Frizzera, the groups, which also include the American Pharmacists Association and the Food Marketing Institute, have urged CMS to alter its new policy.

Starting January 1, CMS will begin enforcing its policy on items in the non-matched National Drug Code (NDC) list. Any medication on the list that is not appropriately registered with the Food and Drug Administration will no longer be covered under Part D.

Consequently, the groups warn, thousands of products currently included on the non-matched NDC list will be denied by Medicare Part D plans.

Many of these products, they point out, are among the medications most commonly used by senior citizens.

“We also strongly urge CMS to consider holding an open-door forum as soon as possible in order to capture the concerns of all interested stakeholders,” the groups say in their letter to Frizzera.

The coalition of pharmacy organizations recommends that a standard CMS fact sheet or similar document be offered online to help pharmacists answer beneficiaries’ questions.
The trade associations also see the new policy leading to a supply problem.

Denying access to one generic drug, they note, will likely increase demand for equivalent generics — of which sufficient supplies may not be readily available, thus further endangering beneficiary access.

According to NACDS and the other groups, some Part D plans may employ point-of-sale (P-O-S) edits at the pharmacy level to block dispensing of unlisted drugs, but others may not, which they say will ignite frustration among patients and pharmacists alike.

The coalition recommends that CMS either update the CMS non-matched NDC list more frequently or require plans to use the FDA’s NDC list to keep P-O-S edits current.

In addition, the coalition wants CMS to prohibit retroactive reversal of approved claims for NDCs that appear on the non-matched list.

These claim reversals, they contend, would be unfair to pharmacies that dispensed the medications pursuant to plans’ approval of claims at the point of sale.

The groups have also urged brand and generic drug manufacturers to intensify their efforts to ensure that their products’ NDCs are registered with the FDA.

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