US pharmacists, drug wholesalers offer solutions to avoid disruption for Medicare beneficiaries

To minimize disruption on patients and pharmacies due to a new policy being implemented by the USA's Centers for Medicare and Medicaid Services (CMS), the American Pharmacists Association (APhA), Food Marketing Institute (FMI), Healthcare Distribution Management Association (HDMA), National Association of Chain Drug Stores (NACDS), and National Community Pharmacists Association (NCPA) have written a letter to CMS Acting Administrator Charlene Frizzera, outlining their concerns and offering potential remedies, urging the agency to continue its outreach to stakeholders.

Starting January 1, 2010, the CMS is scheduled to begin enforcing its non-matched National Drug Code (NDC) list policy. At that time any medication not appropriately registered with the Food and Drug Administration will no longer be covered under Part D. With this deadline fast approaching, thousands of products are currently included on the non-matched NDC list and, thus, scheduled to be denied by Medicare Part D plans in a few weeks. These include many common prescription products seniors rely on, such as antidepressants, antibiotics, pain relievers, and blood pressure and diabetes medicines. (Many drugs have multiple NDCs to reflect the varying strengths, quantities and packaging by which they are sold. However, some drugs may still be covered, but only for the NDCs listed.)

'We strongly encourage you to continue outreach to manufacturers whose products are on the non-matched list as well as Part D plans,' the groups wrote. 'We also strongly urge CMS to consider holding an open door forum as soon as possible in order to capture concerns of all interested stakeholders. Although we have communicated with our respective supply chain partners, ultimately, the manufacturer bears the responsibility to register their products appropriately with the FDA and with Part D plans to ensure their formularies and edits reflect CMS policies in a timely fashion,' the letter stated.

The groups' other concerns include:

' Patient Disruption - Patients may be denied medication they have obtained under Part D for years. The coalition recommends a standard CMS fact sheet or similar document, available online, to help pharmacists answer beneficiaries' questions.

' Supply Chain Concerns ' Denying access to one generic drug will likely increase demand for equivalent generics, of which sufficient supply may not be readily available. Such supply chain issues further endanger beneficiary access.

' Inconsistent Implementation by Part D Plans - Some Part D plans may employ point-of-sale (POS) edits at the pharmacy level to block dispensing of unlisted drugs, but others may not, frustrating patients and pharmacists alike. To promote consistency in implementation, the coalition recommends that CMS either update the CMS non-matched NDC list on a more frequent basis or require plans to utilize the FDA's NDC list to keep POS edits current.

' Retroactive Reversal of Claims ' The coalition urges CMS to prohibit retroactive reversal of approved claims for NDCs that appear on the non-matched list. These claim reversals 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 step up their efforts to ensure their products' NDCs are registered with the FDA, as evidenced by a November 17 letter from the NCPA to its trade associations.