Regulatory Updates For The New Year

January 01, 2009

(As appeared in Pharmacy Times by Bruce T. Roberts, RPh, NCPA Executive Vice President and CEO)

A motto everyone should embrace is proper planning prevents poor performance. The implementation of federal mandated policies for community pharmacies works best when financial and logistical challenges are properly anticipated. In that spirit, I want to provide an update and some helpful advice about four government-issued directives scheduled to start in the beginning of 2009.

The FDA has delayed the compliance date for pharmacies providing labels about the toll-free number for the reporting of adverse side effects from certain drugs until July 1, 2009. The statement must say, "Call your doctor for medical advice on these side effects. You may report side effects to the FDA at 1-800-FDA-1088." When prescription drugs are dispensed, this new requirement can be satisfied by having the warning displayed in one of five ways. You can put a sticker on the product package; use preprinted pharmacy prescription vial caps; provide the statement on a separate piece of paper; issue with consumer medication information; or present through FDA approved medication guides. There are additional requirements regarding the formatting for the adverse effects statement. If you have further questions visit or contact Crystal Riley, NCPA Director of Professional Affairs, at 703-600-1182.

In accordance with new Medicare Part D guidelines, pharmacy staff members will have to receive fraud, waste, and abuse (FWA) training beginning January 1, 2009. Originally part of the Medicare Modernization Act, the FWA guidelines require Part D plans and their downstream entities, including pharmacies, to receive annual FWA training. The training specifics are left to the discretion of each sponsor, which is why you'll see some variation from plan to plan and why it's important to find out what each plan requires. In a nutshell, every pharmacy employee who helps deliver the Part D benefit-from the pharmacist to the cashier-will be required to complete FWA training. Many plans have begun sending pharmacies attestation forms to sign indicating their compliance. Document those efforts because auditors will begin looking for that in the future. For more information, visit or contact Jennifer Bruckart, NCPA Associate Director of Program Outreach, at 703-838-2689.

CMS granted a delay for eliminating computer-generated Medicare fax prescriptions used by pharmacy prescribers. The deadline has been moved from January 1, 2009 until January 1, 2012, which is when e-prescriptions will now comprise the operating system for pharmacies. There are many financial incentives for making the transition beforehand. Starting this January prescribers who use e-prescriptions will receive higher reimbursements through 2013. Prescribers who don't comply by 2012 will see a 2 percent decrease in reimbursements. Data indicates an 11 percent increase in prescriptions filled at pharmacies who have switched over to e-prescriptions. Time is money, and additional data reveals e-prescription usage leads to a 27 percent decrease in staff time for new prescriptions and 10 percent decrease for renewals. SureScripts-RxHub is the main company for e-prescriptions. For additional questions call the Electronic Prescribing Resource Center at 1-866-RxReady.

One regulation has two deadlines, a suggested date for compliance and a point when the compliance window slams shut. Pharmacies seeking to maintain their Medicare Part B billing number must apply for DMEPOS accreditation by January 31, 2009, in order to guarantee they are accredited by September 30, 2009. Those responsible for providing the accreditation have been told to process everyone who makes the January deadline before looking at any applications after that point. In other words, if you snooze you lose, because even a February application is not guaranteed to be processed in time. While NCPA has worked diligently with partners such as the state pharmacy associations for legislation that provides a DMEPOS pharmacy exemption, a fix is unlikely within the time constraints we are working under. For more information, visit or contact Bill Popomaronis, NCPA Vice President of LTC/HHC/NIPCO, at 703-838-2644.

These four different regulations underscore the importance of being a member of NCPA and supporting our legislative efforts. Your involvement, from donations to grassroots mobilizations, allows us achieve the best outcomes with the federal government, especially when they consider issuing new regulations. However, rest assured that NCPA will keep you as informed as possible, as early as possible, to guarantee the implementation of rules that impact your business are as smooth as possible.

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