For the Defense - Volume 2, Issue 4 - 2017 - 15
the Third Circuit in Petratos, holding the heightened standard of materiality required by Escobar
unsatisfied in the absence of an allegation that it
actually affected government decisions to pay.45
In the First Circuit, although the Court concluded
that the Escobar relators had sufficiently pled
materiality on remand, in another qui tam case it
affirmed the dismissal of allegations, holding that
a defendant manufacturer's misrepresentations
about its medical devices defrauded the FDA
could not be material where neither the FDA nor
CMS had reacted in the years since the agencies
had learned of the relator's allegations.46 Other
courts have reached similar conclusions in appeals
from summary judgment.47 And opinions from
various district courts likewise follow this trend.48
The Role of Doctors in Deciding
What Medicare Will Reimburse
One aspect of the Petratos decision may give
qui tam defendants in the healthcare industry
pause, however. Specifically, the Court articulated
"the critical role of the physician in Medicare's
payment and reimbursement scheme," without
delineating precisely how doctors' opinions
affect the materiality analysis.49 Though the
Third Circuit panel acknowledged that "it would
make little practical sense to give the doctors'
materiality determinations dispositive weight,"
it nevertheless disagreed with the District
Court that Avastin claims for on-label uses are
"'reasonable and necessary' as a matter of
law" because the FDA has blessed those uses as
"medically accepted indications."50 Instead, the
Court held that CMS, the primary payor agency
for reimbursement claims, and the FDA, decide
"what treatments can be considered 'reasonable
and necessary,'"51 while doctors "determine
whether a treatment is 'reasonable and necessary
for [that] individual patient.'"52
The opinion leaves some uncertainty, however,
with respect to this issue, at least in the FCA
context. It does not spell out how doctors' views
affect government reimbursement decisions in
practice, and of how those views, then, bear upon
a relator's burden to show materiality. It also
does not explain whether a relator could plead
materiality based on one doctor's opinion that an
FDA-approved treatment was not suitable for an
individual patient. Ironically, in characterizing doctors as "key figure[s] in determining what services
are needed and consequently reimbursable," the
Vol. 2, Issue 4 | For The Defense
15
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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