ALEXANDRIA, Va. (Dec. 1, 2009) – Seniors may find that many common prescription drugs that Medicare Part D has covered for years may suddenly be denied due to a new policy being implemented by the Centers for Medicare and Medicaid Services (CMS).
To minimize disruption on patients and pharmacies, 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 concerns and potential remedies, and urging the agency to continue its outreach to stakeholders.
Starting Jan. 1, 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 (FDA) 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 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 Nov. 17 letter from NCPA to their trade associations.
The American Pharmacists Association, founded in 1852 as the American Pharmaceutical Association, represents more than 62,000 practicing pharmacists, pharmaceutical scientists, student pharmacists, pharmacy technicians, and others interested in advancing the profession. APhA, dedicated to helping all pharmacists improve medication use and advance patient care, is the first-established and largest association of pharmacists in the United States. APhA members provide care in all practice settings, including community pharmacies, health systems, long-term care facilities, managed care organizations, hospice settings, and the uniformed services.
HDMA is the national association representing primary healthcare distributors, the vital link in the healthcare system. Each business day, HDMA member companies ensure that more than nine million prescription medicines and healthcare products are safely delivered to more than 165,000 pharmacies, hospitals, nursing homes, physician offices, clinics and others nationwide. HDMA and its members work daily to provide value and contain costs, saving the nation’s healthcare system an estimated $32 billion per year. For more information, visit www.HealthcareDistribution.org.
The National Association of Chain Drug Stores (NACDS) represents 154 traditional drug stores, supermarkets, and mass merchants with pharmacies – from regional chains with four stores to national companies. NACDS members also include more than 900 pharmacy and front-end suppliers, and over 70 international members from 24 countries. Chains operate 37,000 pharmacies, and employ more than 2.5 million employees, including 118,000 full-time pharmacists. They fill more than 2.5 billion prescriptions annually, which is more than 72 percent of annual prescriptions in the United States. The total economic impact of all retail stores with pharmacies transcends their $815 billion in annual sales. Every $1 spent in these stores creates a ripple effect of $3.82 in other industries, for a total economic impact of $3.11 trillion, equal to 26 percent of GDP. For more information about NACDS, visit www.NACDS.org.
The National Community Pharmacists Association (NCPA®) represents America's community pharmacists, including the owners of more than 22,700 independent community pharmacies, pharmacy franchises, and chains. Together they represent an $88 billion health-care marketplace, employ over 65,000 pharmacists, and dispense over 40% of all retail prescriptions. To learn more go to www.ncpanet.org.