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Ober|Kaler Health Law Alert - Spring 2006




In this Issue

From the Chair

Guide to Terms

Ober|Kaler in Print

Legislation
New Law Creates National Patient Safety Database

OIG Activity
OIG Focus: Part D, Nursing Homes and CMS

Safe Harbor Proposed for Federally Qualified Health Centers

OIG Advisory Opinions

OIG Cites Antikickback Risks with PAPs Under Part D

Long Term Care
Nursing Staff Data-posting Requirement for Nursing Facilities

Hospitals
Providers Score a Victory in DSH Litigation

PHARMA
CMS Relaxes Marketing Rules to Promote Part D Enrollment

Reimbursement
Hospitals Face Increased Risks for Improper Discharge Coding

Self-Referral
CMS Issues First Stark Advisory Opinion in 7 Years

FCA
More Courts Support FCA Actions Based on Kickbacks

First-to-file Bar Held Inapplicable to qui tam Suits

Landmark Clausen Decision Reaffirmed

Enforcement
Proposed Rule Allows Waiver of Exclusion

Litigation/ADR
Erlanger Resolves Scrutiny of its Physician Relationships

Michigan Hospital Settles Voluntary Disclosure of Physician Relationships

Federal Government Settles Investigation of AdvancePCS

Tax
When is a Home Health Agency Not a Home Health Agency?

Antitrust
Full-system Contracting: Business as Usual or Antitrust Time Bomb?

Technology
Stark, Antikickback Protection for E-prescribing, EHR

Physician Focus
More Specificity in Informed Consent

 



Health Law Group

Sanford V. Teplitzky, Chair

Melinda B. Antalek

William E. Berlin

Christi J. Braun

Marc K. Cohen

Thomas W. Coons

John J. Eller

Joshua J. Freemire

Leslie Demaree Goldsmith

Lindsay E. Greenwood

Carel T. Hedlund

S. Craig Holden

Leonard C. Homer

Thomas K. Hyatt

Julie E. Kass

Paul W. Kim

John F. Lessner

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

Steven R. Smith

Howard L. Sollins

E. John Steren

Chiarra-May Stratton

Emily H. Wein

James B. Wieland

Editorial Assistant:
Michele Vicente, Paralegal

 

Landmark Clausen Decision Reaffirmed

Martha P. Rogers
202-326-5050
mrogers@ober.com

Without even hearing argument, the Eleventh Circuit Court of Appeals affirmed the dismissal of a qui tam relator's FCA complaint that had been filed by a former sales employee of two of the defendants. See Corsello v. Lincare, Inc., 2005 WL 2663288 (11th Cir. Oct. 20, 2005). The basis of the dismissal was the relator's failure to plead his fraud claims with particularity as required by Rule 9(b) of the Federal Rules of Procedure Under Rule 9(b), "the circumstances constituting fraud or mistake shall be stated with particularity."

When Mr. Corsello first brought his qui tam action in 1998, he named as defendants 56 entities and 99 John Does and John Doe Corporations. By the time he filed his second amended complaint, only three DME suppliers and a physician remained as defendants.

The Corsello opinion reinforced the court's decision in United States ex rel. Clausen v. Lab. Corp. of Am., Inc., 290 F.3d 1301 (11th Cir. 2002), especially its finding that the act of submitting a fraudulent claim to the government is the "sine qua non" of a False Claims Act violation. Corsello 2005 WL2663288 at *4. Parenthetically, sine qua non is Latin for "without which not," meaning something like "an absolute prerequisite." Accordingly, it was not sufficient for Mr. Corsello, like Mr. Clausen before him, merely to allege that the defendants disregarded government regulations or failed to maintain proper internal policies. Rather, "[b]ecause it is the submission of a fraudulent claim that gives rise to liability under the False Claims Act, that submission must be pleaded with particularity and not inferred from the circumstances." Id. at *5.

Corsello also appealed the denial of his motion to file a third amended complaint. The district court's denial was based on Mr. Corsello's waiting over one year from the dismissal of his second amended complaint, not explaining why he did not plead the necessary facts in the previous versions of his complaint, and failing to offer an amendment that cured the deficiencies of his complaint. The Eleventh Circuit found no error in the district court's denial. In fact, the Court of Appeals concluded that allowing Mr. Corsello to amend his complaint would be "futile" because Mr. Corsello had admitted in his proposed third amended complaint that '"sales people do not .have access to the specific billing information that is submitted to the government' which evidenced that the revised complaint still lacked indicia of reliability." Id. at *6-7.

On January 6, 2006, the Eleventh Circuit Court of Appeals denied Mr. Corsello's petition for rehearing and rehearing en banc.

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