The topic of discussion this week is United States ex rel. Blundell v. Dialysis Clinic, Inc., No. 5:09-cv-00710 (N.D.N.Y. Jan. 19, 2011) , a qui tam action against a dialysis treatment center based on alleged quality of care issues that was recently dismissed pursuant to Rules 9(b) and 12(b)(6). In the Dialysis Clinic case, the relator, a nurse who had been employed by the center, alleged that the center violated certain state and federal standards and regulatory requirements by, e.g., failing to provide adequate staffing, using unqualified personnel, permitting personal care technicians to perform nursing functions, and failing to adequately train employees to handle emergency situations. The relator further claimed that these alleged deficiencies compromised patient care for beneficiaries under the Medicare, Medicaid, and Veterans’ Administration programs. The relator alleged violations of the False Claims Act based on worthless services and false certification theories of liability. The government declined to intervene. The defendant moved to dismiss.

Today, we discuss the portions of the court’s opinion that addressed the defendant’s successful motion to dismiss under Rules 9(b) and 12(b)(6).

Rule 9(b) Analysis

According to the court, the relator “vaguely alleged” that from 2004 to present, the defendant submitted fraudulent claims for payment based upon false certifications that the defendant was in compliance with Medicare rules and regulations for quality of care. The court held that allegations of violations of federal regulations, standing alone, are insufficient to establish a claim under the FCA if the plaintiff cannot identify with any particularity the actual false claims submitted by the defendant. Accordingly, dismissal was appropriate under Rule 9(b) because:

Plaintiff’s complaint contains imprecise references to “routine and systematic” violations of Medicare regulations and while he claims that defendant “submitted thousands of claims for reimbursement of Medicare claims,” he fails to identify even one, specific fraudulent claim. Plaintiff did not annex copies of any bills, claims or other documents to the complaint, amended complaint, or second amended complaint. Moreover, plaintiff failed to provide details regarding any fraudulent claims including when the purportedly false claims were presented, which employee of defendant submitted the claim or the amount of said claim. Plaintiff provided the approximate year of alleged quality of care violations but did not provide specific dates, the names of defendant’s employees who treated the patients, what services were provided or how and by whom false claims were generated as a result of those services. Even if the Court assumes plaintiff’s allegations of compromised patient care to be true, plaintiff has not identified a single bill submitted in relation to any of the examples outlined in the second amended complaint.

Rule 12(b)(6) Analysis

Even though the court dismissed the complaint for failure to plead fraud with particularity under Rule 9(b), it held that an analysis of defendant’s Rule 12(b)(6) arguments was necessary to determine whether the dismissal would be with prejudice or not. The court then examined the viability of the relator’s FCA claims under three theories of liability: worthless services, express false certification, and implied false certification.

Factual vs. Legal Falsity Under the FCA

FCA claims generally fall into two broad categories. First, there are “factually false” claims for goods or services that were never provided or which were incorrectly described. Second, there are “legally false” claims for goods or services that were, in fact, provided, but were provided in violation of a regulation, statute, or prescribed contractual term (despite a certification by the defendant, either express or implied, to the contrary).

Worthless Services Claim

A worthless services claim is a derivative of a factually false claim and asserts that the knowing request of federal reimbursement for a procedure with no medical value violates the FCA irrespective of any certification. Mikes v. Straus, 274 F.3d 687, 702-03 (2nd Cir. 2001); United States ex rel. Lee v. Smithkline Beecham, 245 F.3d 1048, 1053-54 (9th Cir. 2001). In a worthless services claim, the performance of the service is so deficient that for all practical purposes it is the equivalent of no performance at all. Mikes, 274 F.3d at 703.

In the Dialysis Clinic case, the court held that the relator failed to state a claim for worthless services because he did not allege that the clinic failed to provide any services, but rather only challenged the level of care provided:

Plaintiff does not allege that defendant failed to provide any services to their patients. Rather, plaintiff challenges the quality of care arguing that defendant’s services did not conform with the guidelines set forth in 42 C.F.R. § 494. This allegation is not the “equivalent of no performance at all” and thus, does not fit within the worthless services category.

Express False Certification Claim

An express false certification claim is a legally false claim under the FCA. It is based on a false representation of compliance with a federal statute or regulation, and in some instances, with a prescribed contractual term or specification. The majority view (which has been adopted in the Second Circuit and was applied in the Dialysis Clinic case) is that a claim is only legally false when the party certifies compliance with a statute or regulation that is a condition to government payment.

In the Dialysis Clinic case, the relator’s express false certification claim was based on the Medicare enrollment form (Form 855A) that the defendant signed, which provides, in relevant part:

“I agree to abide by the Medicare laws, regulations and program instructions that apply to this provider….I understand that payment of a claim by Medicare is conditioned upon the claim and the underlying transaction complying with such laws, regulations, and program instructions (including, but not limited to, the Federal anti-kickback statute and the Stark law), and on the provider’s compliance with all application conditions of participation in Medicare.”

The relator argued that Form 855A, which defendant signed when it enrolled in Medicare, makes compliance with Medicare regulations a precondition of government payment. The relator further argued that by signing Form 855A, the defendant expressly certified that it would comply with these regulations in order to receive payment. The defendant argued that Form 855A is not a claim for payment and that the form is merely an agreement to comply in the future with all applicable laws and regulations.

The court rejected the defendant’s arguments noted above, but nevertheless held that the relator failed to state an express certification claim. In arriving at this conclusion, the court observed that the problem with the relator’s false certification claim was not necessarily the “forward-looking” language of the certification or that the certification was contained in an enrollment form instead of a claim form. Rather, the court held that the relator failed to state an express certification claim because he did not allege that the defendant made the certifications knowing that they were false when made. In other words, the relator failed to allege that the defendant knew it would violate the applicable Medicare regulations when it signed the enrollment form. Without such pleading, the court held there can be no “false claim” under an express certification theory.

Implied False Certification Claim

An implied false certification claim is also a type of legally false claim under the FCA. Not all circuits recognize implied false certification claims, and the elements of such claims differ from circuit to circuit, and even within circuits. Moreover, the law applicable to such claims has been rapidly evolving. Accordingly, when reviewing implied certification claims, it is important to know the current status of such claims in the particular jurisdiction in which the claim is asserted. For more information on recent court decisions addressing implied certification claims, see our posts here, here, and here.

The Dialysis Clinic case was brought in the Northern District of New York, and thus Second Circuit precedent applies. In the Second Circuit, an implied certification claim “is based on the notion that the act of submitting a claim for reimbursement itself implies compliance with governing federal rules that are a precondition to payment.” Mikes, 274 F.3d at 699. In Mikes v. Straus, the Second Circuit limited the use the implied certification claims against medical providers as follows:

[I]mplied false certification is appropriately applied only when the underlying statute or regulation upon which the plaintiff relies expressly states the provider must comply in order to be paid. Liability under the Act may properly be found therefore when a defendant submits a claim for reimbursement while knowing – as that term is defined by the Act – that payment expressly is precluded because of some noncompliance by the defendant.

In the Dialysis Clinic case, the relator alleged that the defendant was liable under the FCA for impliedly certifying compliance with the conditions set forth in 42 C.F.R. § 494 et seq. The defendant argued that § 494 provides conditions for coverage, and does not operate as a precondition for payment. The relator conceded that § 494 does not expressly condition payment on compliance with its terms, but argued instead that “nothing in Part 494 would permit a medical provider to assert a claim for money services rendered in violation of regulatory requirements.” The court disagreed with the relator and held that 42 C.F.R. § 494 “clearly establishes a condition of participation, not prerequisites to receiving reimbursement from the government.” Based on this reasoning, the court held that defendant’s alleged non-compliance with § 494 et seq. does not impose liability under an implied false certification theory.

Accordingly, the relator’s complaint was dismissed with prejudice. A copy of the second amended complaint which was dismissed can be found here.

Tomorrow, we will discuss the court’s ruling on the defendant’s motion to dismiss the action for lack of subject matter jurisdiction under the FCA’s public disclosure bar.