NABP e-News January 10, 2008

January 10, 2008 12:00 AM

CMS Announces MSAs, Product Categories for Round Two of DMEPOS Competitive Bidding
Centers for Medicare and Medicaid Services (CMS) announced on January 8, 2008, the metropolitan statistical areas (MSAs) and product categories for the second round of the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive bidding program. The program is designed to improve the effectiveness of Medicare's DMEPOS payments, reduce beneficiary out-of-pocket costs, and save the Medicare program money while ensuring beneficiary access to quality DMEPOS items and services. All suppliers must meet quality standards and be accredited by a CMS-recognized accreditation organization to obtain a contract under the Medicare DMEPOS competitive bidding program. The final deadline for all suppliers to obtain accreditation is September 30, 2009; however, CMS encourages suppliers to seek accreditation as soon as possible to avoid any potential difficulties that would affect their ability to bid. More information, including the lists of MSAs and product categories, is available on the CMS Web site at www.cms.hhs.gov/CompetitiveAcqforDMEPOS.

Rule Requires Drug Labels to Include Toll-Free Number for Reporting Adverse Events
Food and Drug Administration (FDA) issued an interim final rule in the January 3, 2008 Federal Register requiring certain medication labels to include a toll-free number for reporting adverse events. The interim final rule codifies provisions of the proposed rule Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products' that became effective on January 1, 2008, under the FDA Amendments Act of 2007. The rule does not apply to over-the-counter medications approved as new drugs if the product packaging includes a manufacturer's or distributor's toll-free number for reporting complaints. To allow manufacturers, dispensers, and pharmacies time to update their labeling and systems to comply with the new requirements, FDA will delay enforcement actions regarding these regulations until January 1, 2009. More information is available in the Federal Register (Docket No. 2003N-0342) at www.fda.gov/OHRMS/DOCKETS/98fr/E7-25426.pdf.

Bayer Diabetes Care Recalls Contour Test Strips
Bayer Diabetes Care recently recalled test strips (sensors) for use with the Contour TS Blood Glucose Meter. The company recalled the product because test strips from specific lots could result in blood glucose readings with a positive bias that could demonstrate 5% to 17% higher test results. This issue is unrelated to the Contour TS meter itself and pertains only to certain test strips used with the meter. Strips used with other Bayer meters are unaffected. Health care professionals are advised to check the lot number of the Contour test strips in their inventory and contact Bayer Diabetes Care for information on the return and replacement of strips. More information is available in the manufacturer's press release at www.fda.gov/medwatch/safety/2007/contourTS_recall.htm.

NABP Awards DMEPOS Accreditation to Additional Pharmacy
NABP recently accredited The Corner Drugstore in Hemet, CA, through its durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) accreditation program. The DMEPOS program ensures that pharmacies supplying DMEPOS products meet the Centers for Medicare and Medicaid Services (CMS) quality and accreditation standards. The Corner Drugstore is an independent pharmacy that has been in business for more than 35 years. A complete list of pharmacies accredited through the NABP DMEPOS program is available under Accreditation Programs on the NABP Web site.