For the Defense - Volume 2, Issue 4 - 2017 - 16
Court relies on a case in which the Second Circuit
held that "deference to a physician's judgment is
appropriate only in the absence of a [contrary government reimbursement] policy."53 As this shows,
while doctors have indeed played a key role in
extending Medicare coverage, the Court's analysis
now allows the opinions of individual doctors to
limit what is reimbursable, countermanding even
FDA approval or other support in the medical
community, such as drug compendia.
Already, courts are struggling with the implications of this analysis, as recent cases demonstrate. In
late July, a First Circuit panel affirmed the dismissal
of FCA allegations that a hip replacement manufacturer defrauded the FDA by making false statements that secured FDA approval for the device.54
The Court held that the relators, two doctors, failed
to plead materiality where the complaint did not
allege that any doctor submitted a claim that they
would not have absent the defendant's alleged
misrepresentations, or that the misrepresentations
affected reimbursement. But the First Circuit cited
Petratos for the proposition that "a product may
be sufficiently 'safe' and 'effective' to secure FDA
approval for a given use, yet its use might nonetheless not be sufficiently 'reasonable and necessary'
for patient care to warrant Medicare reimbursement for its use."55 As the Court theorized, "it is
possible that a particular attribute of a product
would not be required to secure FDA approval, yet
it would be necessary to secure reimbursement. In
such circumstances, a manufacturer's false statement that its product possesses such an attribute
might in theory both cause the presentment of a
claim and be material to the government's decision
to pay the claim in a way that involves no second
guessing of the government's still-extant FDA
approval of the product."56
Within the Third Circuit, district courts have
also been grappling with this issue in the wake of
Petratos. Thus, one court has interpreted the Third
Circuit's language about the role that doctors
might play in deciding what was "reasonable and
necessary" for purposes of the FCA to alone satisfy
the materiality standard, another has concluded
that, doctors' opinions were entirely irrelevant,
at least where the government had provided for
16
For The Defense | Vol. 2, Issue 4
automatic reimbursement. These conflicting results
at the district court level demonstrate the inherent
tension inherent in the Third Circuit's approach,
which both pronounces a high materiality burden
and yet exalts, to at least some extent, the role of
doctors in determining payment.
Specifically, in one case in the District of New
Jersey, a defendant argued that the relators failed
to plead materiality because the complaint failed
to include factual allegations that the government
would not reimburse claims for on-label uses of
an HIV drug. The District Court disagreed, holding
that the defendants' misrepresentations and suppression of information concerning the drug's side
effects caused doctors to certify that prescriptions
for on-label uses of the drug were "reasonable
and necessary," causing the submission of "false"
claims for reimbursement under Medicare and
Medicaid.57 The Court expressly found it "persuasive" that Petratos interpreted "reasonable
and necessary" to include the determinations of
individual doctors.58 As a result, though relators
alleged, in conclusory fashion, that "each of
Defendants' claims for government reimbursement . . . included false certifications rendering the
claims 'ineligible for reimbursement,'" the Court
determined that "Relators have adequately pled
that Defendants' misconduct would have caused
the Government to refuse reimbursement."59 This
decision, at least implicitly relying upon what
individual doctors might determine to be reasonable and necessary, appears not to square with the
Petratos Court's materiality analysis.
In the Plavix decision, discussed above, a
different District Court, confronting similar claims,
granted the defendant's motion to dismiss.60
There, the defendant's misrepresentations about
the drug's cost-effectiveness were not deemed
material to the government's payment decision,
even if those misrepresentations caused doctors to
prescribe (and the government to pay for) more
Plavix. The Court reasoned that doctors' certifications about the cost-effectiveness of on-label
prescriptions for the drug were irrelevant because
government payors had already decided to
reimburse for these on-label uses.61 As in Petratos,
"while the Prescriber Allegations may suggest
Table of Contents for the Digital Edition of For the Defense - Volume 2, Issue 4 - 2017
Table of Contents
Commonwealth v. Jerome King and Beyond: Trial Counsel’s Obligation to Cooperate with an Ineffective Assistance of Counsel Claim
United States ex rel. Petratos v. Genentech Inc. – The Third Circuit Embraces A Rigorous Pleading Standard for Materiality In False Claims Act Suits, But Leaves Healthcare Industry Defendants Vulnerable On Medicare Claims
Changes in the DUI Landscape: Acts 33 and 30
Police Misconduct Resulting in Arrest: Weighing the Options
Dying with Dignity: Compassionate Release in Pennsylvania
Amicus Matters
Attorney Discipline
Finding the Hidden Data in Technology to Defend Your Client
For the Defense - Volume 2, Issue 4 - 2017 - 1
For the Defense - Volume 2, Issue 4 - 2017 - 2
For the Defense - Volume 2, Issue 4 - 2017 - Table of Contents
For the Defense - Volume 2, Issue 4 - 2017 - 4
For the Defense - Volume 2, Issue 4 - 2017 - Commonwealth v. Jerome King and Beyond: Trial Counsel’s Obligation to Cooperate with an Ineffective Assistance of Counsel Claim
For the Defense - Volume 2, Issue 4 - 2017 - 6
For the Defense - Volume 2, Issue 4 - 2017 - 7
For the Defense - Volume 2, Issue 4 - 2017 - 8
For the Defense - Volume 2, Issue 4 - 2017 - 9
For the Defense - Volume 2, Issue 4 - 2017 - 10
For the Defense - Volume 2, Issue 4 - 2017 - United States ex rel. Petratos v. Genentech Inc. – The Third Circuit Embraces A Rigorous Pleading Standard for Materiality In False Claims Act Suits, But Leaves Healthcare Industry Defendants Vulnerable On Medicare Claims
For the Defense - Volume 2, Issue 4 - 2017 - 12
For the Defense - Volume 2, Issue 4 - 2017 - 13
For the Defense - Volume 2, Issue 4 - 2017 - 14
For the Defense - Volume 2, Issue 4 - 2017 - 15
For the Defense - Volume 2, Issue 4 - 2017 - 16
For the Defense - Volume 2, Issue 4 - 2017 - 17
For the Defense - Volume 2, Issue 4 - 2017 - Changes in the DUI Landscape: Acts 33 and 30
For the Defense - Volume 2, Issue 4 - 2017 - 19
For the Defense - Volume 2, Issue 4 - 2017 - 20
For the Defense - Volume 2, Issue 4 - 2017 - 21
For the Defense - Volume 2, Issue 4 - 2017 - Police Misconduct Resulting in Arrest: Weighing the Options
For the Defense - Volume 2, Issue 4 - 2017 - 23
For the Defense - Volume 2, Issue 4 - 2017 - 24
For the Defense - Volume 2, Issue 4 - 2017 - 25
For the Defense - Volume 2, Issue 4 - 2017 - 26
For the Defense - Volume 2, Issue 4 - 2017 - 27
For the Defense - Volume 2, Issue 4 - 2017 - 28
For the Defense - Volume 2, Issue 4 - 2017 - Dying with Dignity: Compassionate Release in Pennsylvania
For the Defense - Volume 2, Issue 4 - 2017 - 30
For the Defense - Volume 2, Issue 4 - 2017 - 31
For the Defense - Volume 2, Issue 4 - 2017 - 32
For the Defense - Volume 2, Issue 4 - 2017 - 33
For the Defense - Volume 2, Issue 4 - 2017 - 34
For the Defense - Volume 2, Issue 4 - 2017 - Amicus Matters
For the Defense - Volume 2, Issue 4 - 2017 - 36
For the Defense - Volume 2, Issue 4 - 2017 - 37
For the Defense - Volume 2, Issue 4 - 2017 - 38
For the Defense - Volume 2, Issue 4 - 2017 - 39
For the Defense - Volume 2, Issue 4 - 2017 - Attorney Discipline
For the Defense - Volume 2, Issue 4 - 2017 - 41
For the Defense - Volume 2, Issue 4 - 2017 - 42
For the Defense - Volume 2, Issue 4 - 2017 - 43
For the Defense - Volume 2, Issue 4 - 2017 - Finding the Hidden Data in Technology to Defend Your Client
For the Defense - Volume 2, Issue 4 - 2017 - 45
For the Defense - Volume 2, Issue 4 - 2017 - 46
For the Defense - Volume 2, Issue 4 - 2017 - 47
For the Defense - Volume 2, Issue 4 - 2017 - 48
For the Defense - Volume 2, Issue 4 - 2017 - 49
For the Defense - Volume 2, Issue 4 - 2017 - 50
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