United States Ex Rel. Jamison v. McKesson Corp., 784 F. Supp. 2d 664

CSMS formed to supply enteral nutrition and related DMEPOS to Beverly's facilities and sought its own Medicare DMEPOS supplier number.
NSC inspected CSMS, found it compliant with the 21 DMEPOS Supplier Standards in 2003 and again in 2006 for re-enrollment and operations.
NSC issued notices in 2007 revoking CSMS's supplier number for alleged violations of Standards One, Two, and others, prompting a corrective action plan and an appeal.
CSMS argued it complied or sought exemptions, provided licensure information where available, and contended certain licensure requirements did not apply to its operations.
CMS reinstated CSMS's supplier number retroactively to the date of compliance determination after an administrative revocation in 2007.
In 2009 NSC again revoked CSMS's supplier number for alleged licensure deficiencies (Standard One and Two), leading CSMS to submit further CAPs and seek reconsideration.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether Government proves a false claim under FCA	Government contends CSMS submitted false claims despite noncompliance.	CSMS and McKesson argue no false claim because CSMS was entitled to payment and acted in good faith reliance on NSC/CMS determinations.	No; government failed to prove an objective falsehood or noncompliance; claims dismissed.
Whether CSMS violated any DMEPOS Supplier Standard	Government asserts multiple Standards were violated in the enrollment and operation of CSMS.	CSMS maintained compliance or acted reasonably given regulatory interpretations and NSC/CMS determinations.	No; Government failed to prove violations of the asserted Standards; standards defense supported.
Whether reliance on NSC/CMS determinations defeats FCA liability	Government argues lack of good faith reliance is not excused by agency determinations.	CSMS and Beverly/McKesson relied in good faith on NSC/CMS determinations that CSMS complied with Standards.	Yes; reliance on regulatory determinations and retroactive certification supports no liability under FCA.
Whether prior administrative proceedings bar FCA claims	Government may rely on findings of noncompliance from prior proceedings.	Administrative history shows compliance determinations and retroactive effect for payments; not actionable false claims.	Not reaching res judicata; court dismissed the claims on merits for lack of false claim and noncompliance.

Southland Mgmt. Corp. v. United States, 326 F.3d 669 (5th Cir. 2003) (false claim element and reliance on government determinations)
Clausen v. Lab. Corp. of Am., 290 F.3d 1301 (11th Cir. 2002) (claims must be false and knowingly fraudulent)
Willard v. Humana Health Plan of Tex., Inc., 336 F.3d 375 (5th Cir. 2003) (FCA requires knowing payment of non-owed money; regulatory noncompliance alone is insufficient)
Lamers v. City of Green Bay, 168 F.3d 1013 (7th Cir. 1999) (ambiguity in law and good faith preclude falsity finding)
Hopper v. Solvay Pharms., Inc., 588 F.3d 1318 (11th Cir. 2009) (false claim requires objective falsehood; not mere regulatory dispute)
United States ex rel. Wilson v. Kellogg Brown & Root, Inc., 525 F.3d 370 (4th Cir. 2008) (elements of FCA require meaningful falsity and scienter)
United States v. Southland Mgmt. Corp., 326 F.3d 669 (5th Cir. 2003) (claims must concern money due; government reliance on agency determinations)
Harrison v. Westinghouse Savannah River Co., 176 F.3d 776 (4th Cir. 1999) (FCA not a general enforcement tool for regulatory non-compliance)