Ober, Kaler, Grimes & Shriver, A Professional Corporation  
Ober|Kaler Health Law Alert - Spring 2005




In this Issue

From the Chair

Congratulations

Guide to Terms

Ober|Kaler in Print

OIG Activity
OIG Approves Six Gainsharing Arrangements

OIG Advisory Opinions

OIG 2005 Work Plan

CMS Developments
CMS Proposes Plan to Pay Unpaid Costs of Emergency Health Care

Trailblazer Fraud Alert Reveals Provider Identity Theft

Long Term Care
Discerning the New Pressure Ulcer Guidelines

Pharma
TAP Pharmaceuticals Settles with Lupron Consumers

Hospitals
Pay for Performance: Will Your Hospital Be Ready?

Nonphysician Practitioners
"Incident To" Rule Changes

Compliance
OIG Finalizes Supplemental Hospital Compliance Guidance

OIG's Supplemental Hospital CPG Looks at Hospital-based Physicians

OIG/AHLA Release Second Compliance Resource

Reimbursement
IRF "75 Percent Rule" Blocked

Correct Minor Errors and Omissions Without Appeals

Self-referral
Hospitals Meet "Under-development"

FCA
Courts Apply Strict Interpretation of Officer or Employee Under FCA

Lack of Pharmaceutical Recycling Guidance Precludes FCA Liability

Questionable Incentive Program Raises FCA Liability

Enforcement
Supreme Court Declares Sentencing Guidelines "Advisory"

Tax
IRS Penalizes Health System for PAC/Payroll Deduction Plan

Antitrust
DOJ/FTC Report on Antitrust in Health Care

Physican Focus
Physician Retention Arrangements: Stark and Antikickback Issues

Employment
Alien Certification Exemption to Avert Staffing Crisis

 

TAP Pharmaceuticals Settles with Lupron Consumers

Michele M. Vicente, CLA
Paralegal

When TAP Pharmaceuticals paid $875 million in 2001 to settle criminal and civil charges of fraudulent drug pricing and marketing of its cancer drug, Lupron, it was one of the largest amounts ever paid in a health care fraud prosecution. Even so, the amount paid did not include compensation for the health insurers and consumers who alleged they had been overcharged for the drug. The civil claims brought against TAP Pharmaceuticals by a nationwide class of insurers and consumers were resolved November 24, 2004, when TAP agreed to pay Lupron purchasers $150 million as compensation for the allegedly inflated prices they paid for the cancer drug.

Lupron is an injectible drug used primarily to treat prostate cancer, endometriosis, uterine fibroids, and precocious puberty. The class action claimed that consumer prices for Lupron were inflated as a result of TAP Pharmaceutical's sales, pricing, and marketing practices, which allegedly included artificially inflating the Average Wholesale Price of the drug; giving doctors free samples for which the company knew the doctors would charge patients and insurers; and giving doctors incentives for prescribing Lupron. The settlement did not include an admission of wrongdoing by TAP Pharmaceuticals.

The settlement involved two separate classes of plaintiffs: one a group of health insurance companies and health plans (Settling Health Plans (SHP) Group); the other a Lupron Purchaser Class comprised of third-party payors and individual consumers. Under the terms of the settlement, $55 million of the $150 million settlement amount would be paid to the SHP Group. The remaining $95 million would be paid to the Lupron Purchaser Class, with $40 million allocated to consumers and $55 million to third-party payors. s

Class members can access documents related to the Lupron settlement, including claim forms, through the official court website for the Lupron class action settlement at www.lupronclaims.com.

Copyright© 2005, Ober, Kaler, Grimes & Shriver