Ober, Kaler, Grimes & Shriver, A Professional Corporation  
Ober|Kaler Health Law Alert - Fall 2001




In this Issue

From the Chair

Guide to Terms

OIG Activity
OIG Posts New CIA FAQs on Site Visits

OIG Announces FY 2002 Work Plan

OIG's Semiannual Report for First Half of FY 2001

OIG Advisory Opinions

CMS Developments
Proposed State Exemption from CRNA Supervision Requirements

Reimbursement
Final Inpatient Rehab PPS Rules

Tougher Audit Procedures Expected Under Recent PM

Long Term Care
CMS to Recover Improper Part B Payments for Part A SNF Patients

GAO Report Critiques VA's Plans to Increase Nursing Home Oversight

EMTALA
EMTALA Q&A

Pharma
OIG Reviews Medicaid Use of Revised Average Wholesale Prices

More of the Same...OIG Scrutinizes Actual Acquisition Cost of Brand Name Drugs

False Claims Act
Qui Tam News: Multiple Circuits Rule in Qui Tam Suits

Self-referral
Stark and the Maryland Referral Law

Litigation and Dispute Resolution
The Future of CIAs?

Business
FASB Issues New Accounting Rules for Goodwill

Antitrust
Health Care Antitrust: The Year in Review

Peer Review
Physician Credentialing and Peer Immunity Laws Withstand Scrutiny

Physician Focus
Yes, Physician Practices Must Provide Interpreters

Employment
Hospitals Have Opportunity to Hire Alien Nurses

Supreme Court Holds Charge Nurses Are Supervisors Under NLRA


Health Law Group

Sanford V. Teplitzky, Chair

Melinda B. Antalek

Jana L. Artnak

Laura Callahan

Jacqueline A. Carberry

Marc K. Cohen

Thomas W. Coons

Janet DiAntonio

John J. Eller

Leslie Demaree Goldsmith

Carel T. Hedlund

S. Craig Holden

Leonard C. Homer

Thomas K. Hyatt

Julie E. Kass

John F. Lessner

Catherine A. Martin

William T. Mathias

Robert E. Mazer

Carol M. McCarthy, Ph.D.

John J. Miles

Christine M. Morse

Patrick K. O'Hare

Leon Rodriguez

Martha Purcell Rogers

Laurence B. Russell

Donna J. Senft

Ray M. Shepard

Harry R. Silver

Howard L. Sollins

E. John Steren

Robert A. Wells

James B. Wieland

Jillian Wilson

Editorial Assistant:
Michele Vicente, Paralegal

 

OIG Reviews Medicaid Use of Revised Average Wholesale Prices

Catherine A. Martin

The OIG recently issued an inspection report on the use of revised average wholesale prices (AWP) by state Medicaid agencies for certain prescription drugs. Medicaid's Use of Revised Average Wholesale Prices, OEI-03-01-00010 (Sept. 2001). For several years, the OIG has focused on the "inflation" of the reported average wholesale price, which is utilized by many states as the primary basis for determining drug cost reimbursement. According to the OIG, the impact of inflated AWP on the Medicaid program is clear: Medicaid ends up paying too much for certain products.

Recently, the DOJ and the National Association of Medicaid Fraud Control Units (NAMFCU) conducted a national investigation targeting the AWP issue. The investigation revealed that some drug manufacturers sold products at far less than AWP data reported by pricing services. These pricing companies, such as First Databank and Medical Economic, compile the AWP that is eventually relied upon by states for reimbursement purposes. In an effort to eliminate the inflation factor that has become integrated in drug pricing, DOJ and NAMFCU collected actual pricing data on approximately 400 national drug codes representing 51 drugs. The data was provided to First DataBank, who calculated revised AWPs for the drugs and made the revised AWPs available to states for use in calculating reimbursement.

The OIG's report takes a look at this most recent effort aimed at obtaining more accurate pricing for the Medicaid program: revised AWP. The OIG looked at 48 states and the District of Columbia. Revised AWP has received mixed reviews. The OIG found that 30 states are using some of the revised AWPs; however, the method by which the revised AWPs are used varies significantly. States are using a combination of methods, including federal upper limits and state maximum allowable costs and revised AWP, when calculating reimbursement.

The OIG found that 11 states using the revised AWP are not subtracting a percentage discount when calculating payment for drugs with a revised AWP, because the states view the revised AWP as being closer to true acquisition cost. Along these lines, states reported concern that subtracting a percentage discount from the revised AWP would cause reimbursement to fall below a provider's acquisition cost, putting drug availability and patient access to care at risk. This is a valid concern that is often overlooked in the AWP debate.

States reported both advantages and disadvantages to the use of revised prices. States supporting revised AWP seemed to focus on the "extreme" inflation of AWP and welcomed any attempt to obtain more accurate pricing. Other states, while appreciating the need for accurate pricing, questioned the usefulness of revised AWP, suggesting that savings would be minimal. Those states noted that the drugs with revised AWPs were low-utilization products and predicted that utilization will simply shift to those products not subject to the price revision. All of the states noted opposition from hemophilia providers, pharmacies, infusion providers, physicians, and drug manufacturers, who claim the revised prices are simply too low. This voiced opposition has not gone unnoticed. Two states have stopped using the revised AWP for blood-factor products after hemophilia providers claimed that they would be unable to continue treating Medicaid recipients. Other states are contemplating similar action.

Most significantly, the majority of the states expressed the view that revised AWP will result in short-term savings, but remained skeptical of any long-term effect on savings. As support, many states cited ways in which manufacturers and providers would eventually circumvent the new prices: manufacturers could obtain new national drug codes for drugs with revised AWPs and submit a higher AWP for those new codes; or providers could substitute drugs with higher-priced national drug codes in place for those with revised prices.

The OIG concluded by noting that while some states are benefiting from revised AWPs, the long-term effects of this strategy are questionable. The OIG acknowledged that the current reimbursement system that relies on reported AWP is "fundamentally flawed." CMS agreed with the OIG that the current system is problematic and agreed to continue looking for administrative and legislative solutions to this problem.

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