November 2012 Volume 9 Number 3

NACDS General Counsel To Address Major Pharmacy Issues at 10th Annual ABA Washington Health Law Summit Luncheon

By Ned Milenkovich, McDonald Hopkins LLC, Chicago, IL*

AuthorOn December 3-4, 2012, the American Bar Association will be hosting its 10th Annual Washington Health Law Summit. This time-honored event will take place at the Washington Marriott Wardman Park. The featured luncheon program will be presented by Senior Vice President and General Counsel of the National Association of Chain Drug Stores, Mr. Don Bell, II.

Mr. Bell will emphasize the changing pharmacy landscape and address some of the legal challenges that the drug and pharmacy industry is facing. For example, there will be ongoing threats and opportunities associated with implementing the massive healthcare reform law, which contains specific provisions related to pharmacies and the medications they dispense. Some of these issues revolve around Medicare Part D, pharmacist medication therapy management services, durable medical equipment accreditation, pharmacy benefit management transparency, Medicaid reimbursement for generics, and pharmacy and small-business reforms.

The session will review selected litigation and regulatory activities associated with shrinking reimbursement rates in Medicaid and other programs, as well as the implementation of several new cost-reimbursement proposed models that could have an impact on how pharmacies conduct their business.

In addition, the session will focus on major challenges associated with audits in terms of both what payor programs expect from pharmacies and how pharmacies are protecting themselves from aggressive audits that may result in reimbursement clawbacks and possible exclusion from a payor reimbursement network. Also, the session will address compliance with many new fraud and abuse compliance programs.

Mr. Bell will also touch on Drug Enforcement Administration (“DEA”) enforcement issues against pharmacies, corresponding pharmacy dispensing responsibility, PMP programs and e-prescribing technology.

Finally, Mr. Bell will address the NECC meningitis fungal contamination resulting in numerous patient deaths across the country. The focus of the discussion will include efforts by state boards of pharmacy to invoke standards of pharmacy practice while the federal government also introduces legislation to distinguish those pharmacies engaged in traditional pharmacy practice from those undertaking manufacturing-type activities, thereby falling within the scope of Food and Drug Administration (“FDA”) oversight.

A complete presentation will take place on Monday, December 3, 2012 from 12:45-1:45 PM on the first day of the two-day ABA Health Law Summit, during the luncheon. Tickets are included with your conference registration. Details can be found at ambar.org/WHLS.


*Ned Milenkovich PharmD, JD is a member at McDonald Hopkins LLC and chairs its drug and pharmacy practice group. He is also Vice-Chairman of the Illinois State Board of Pharmacy and is a member of the Washington Health Law Summit 2012 planning committee. Ned can be reached at 312-642-1480 or at nmilenkovich@mcdonaldhopkins.com.


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