Download Medicare Part D (cont.)

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Drugs and Devices, the False Claims Act and
P
»>r.(-)
© Copyright, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., 2007
non-exclusive license to American Bar Association
T
American Bar Association
Health Law Section
Emerging Issues in Healthcare Law 2007
February 21-23, 2007
Off-label Marketing of Prescription
Thomas S. Crane
Health Law Section
February 21-23, 2007
Thomas S. Crane
the Impact of Medicare Part D
American Bar Association
Emerging Issues in Healthcare Law 2007
MINTZ LEUIN
NT/
I M I A \'IN COI IN
© Copyright, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., 2007
non-exclusive license to American Bar Association
Off-label Marketing of Prescription
Drugs and Devices, the False Claims Act and
the Impact of Medicare Part D
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The views expressed in these materials and in the
seminar presentation are the personal views of the
presenter and do not represent the formal position of
Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C.,
any other individual attorneys at the frm, or any of its
clients. The presenter expressly reserves the right to
advocate freely other positions on behalf of clients.
© Copyright, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., 2007
non-exclusive license to American Bar Association
NOTE
NOTE
The views expressed in these materials and in the
seminar presentation are the personal views of the
presenter and do not represent the formal position of
Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C.,
any other individual attorneys at the firm, or any of its
clients. The presenter expressly reserves the right to
advocate freely other positions on behalf of clients.
MINTZ LEVIN
MINI r. I,EVIN COI IN l riuiis G.OVS
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1
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¾ OIG and Industry Guidance
? OIG and Industry Guidance
¾ Fraud and Abuse Enforcement Activity
OUTLINE
? Fraud and Abuse Enforcement Activity
? Medicare Part D
© Copyright, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., 2007
non-exclusive license to American Bar Association
OUTLINE
¾ Medicare Part D
MINTZ LEVIN
MINI r. I,EVIN COI IN l riuiis (ii .OVS
© Copyright, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., 2007
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2
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? Compliance Guidance
¦ The OIG has solicited comments on and has fnalized a
¦ Compliance guidance being developed for researchers
© Copyright, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., 2007
non-exclusive license to American Bar Association
OIG Compliance
OIG Compliance
series of 11 compliance guidance documents each
applicable to a different component of the health care
delivery system. These guidance offer valuable assistance
and provide the OIG's insight. Examples:
© Copyright, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., 2007
non-exclusive license to American Bar Association
• Pharmaceutical Manufacturers (2003)
• Physicians (2000)
• Hospitals (1998) - due to be reissued in updated form
soon
MINTZ L,EUIN
MI\I% I,P.VIN Coi IN I?FRRISGIO
¾ Compliance Guidance
ƒ The OIG has solicited comments on and has finalized a
series of 11 compliance guidance documents each
applicable to a different component of the health care
delivery system. These guidance offer valuable assistance
and provide the OIG’s insight. Examples:
• Pharmaceutical Manufacturers (2003)
• Physicians (2000)
• Hospitals (1998) – due to be reissued in updated form
soon
ƒ Compliance guidance being developed for researchers
3
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Guidance for Pharmaceutical Manufacturers (the "Pharma
Guidance"). While the Pharma Guidance is for
pharmaceutical manufacturers, and is intended to assist them
with their compliance activities, it provides valuable insight
for any provider.
members, and GPOs (among others) are persons or entities
in a position to generate Federal health care business.
OIG Guidance for Pharmaceutical
? In April 2003, the OIG issued its fnal Compliance Program
? Purchasers, benefit managers, formulary committee
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non-exclusive license to American Bar Association
OIG Guidance for Pharmaceutical
Manufacturers
MINTZ LEUIN
MFN i . ARVIN COI IN FERRIS G
o
© Copyright, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., 2007
non-exclusive license to American Bar Association
Manufacturers
¾ In April 2003, the OIG issued its final Compliance Program
Guidance for Pharmaceutical Manufacturers (the “Pharma
Guidance”). While the Pharma Guidance is for
pharmaceutical manufacturers, and is intended to assist them
with their compliance activities, it provides valuable insight
for any provider.
¾ Purchasers, benefit managers, formulary committee
members, and GPOs (among others) are persons or entities
in a position to generate Federal health care business.
4
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agreements, between pharmaceutical manufacturers and
purchasers should be structured, whenever possible, to ft
within the personal services safe harbor; Pharma Guidance
notes that any remuneration from a pharmaceutical
manufacturer to a purchaser could implicate the kickback
provisions and should be carefully reviewed.
OIG Guidance for Pharmaceutical
? Data collection service agreements, as well as other
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OIG Guidance for Pharmaceutical
Manufacturers (cont.)
MINTZ LEVIN
MIN-rr. I,IiVIN COI iN I:r•iuusG
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non-exclusive license to American Bar Association
Manufacturers (cont.)
¾ Data collection service agreements, as well as other
agreements, between pharmaceutical manufacturers and
purchasers should be structured, whenever possible, to fit
within the personal services safe harbor; Pharma Guidance
notes that any remuneration from a pharmaceutical
manufacturer to a purchaser could implicate the kickback
provisions and should be carefully reviewed.
5
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to, customers' purchases could implicate the kickback
provisions.
communications with physicians and patients and notes that,
while these communications indirectly beneft the
manufacturer, "the primary economic benefciary is typically
the formulary sponsor."
OIG Guidance for Pharmaceutical
? Rebates or payments that are based on, or otherwise related
? Pharmaceutical manufacturers may provide funding for
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OIG Guidance for Pharmaceutical
Manufacturers (cont.)
MINTZ LEVIN
M [N i r. I A VIN COI IN FERRIS
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Manufacturers (cont.)
¾ Rebates or payments that are based on, or otherwise related
to, customers’ purchases could implicate the kickback
provisions.
¾ Pharmaceutical manufacturers may provide funding for
communications with physicians and patients and notes that,
while these communications indirectly benefit the
manufacturer, “the primary economic beneficiary is typically
the formulary sponsor.”
6
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OIG Guidance for Pharmaceutical
? Educational grants and research funding could raise issues under
the kickback provisions if they are conditioned in whole or in
part on the "purchase of product" even if the purpose of the
program is legitimate.
? "Grant making functions" should be separated from "sales and
marketing functions." To the extent the manufacturer has any
influence over the substance of an educational program or a
presenter, there is a risk it will be used for inappropriate
marketing purposes.
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OIG Guidance for Pharmaceutical
Manufacturers (cont.)
MINTZ LEUIN
MFN i . I,PVIN COI IN FERRIS GLOV
130111--,()
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non-exclusive license to American Bar Association
Manufacturers (cont.)
¾ Educational grants and research funding could raise issues under
the kickback provisions if they are conditioned in whole or in
part on the “purchase of product” even if the purpose of the
program is legitimate.
¾ “Grant making functions” should be separated from “sales and
marketing functions.” To the extent the manufacturer has any
influence over the substance of an educational program or a
presenter, there is a risk it will be used for inappropriate
marketing purposes.
7
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Scientific and Educational Activities
? Issued in 1997
? Programs performed by, or on behalf of, companies that market
pharmaceuticals are subject to FDA's requirements on advertising
and labeling
? FDA does not regulate independent and non-promotional
industry- supported activities
? Determination of independence includes:
¦ Control of content
¦ Inclusion of promotional material
¦ Single-product marketing vs treatment options
¦ Source of invitation lists
FDA Guidance on Industry-Supported
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FDA Guidance on Industry-Supported
Scientific and Educational Activities
MINTZ L,EUIN
MINTZ LIMN COI IN l r.rris C ?i.
¾ Issued in 1997
¾ Programs performed by, or on behalf of, companies that market
pharmaceuticals are subject to FDA’s requirements on advertising
and labeling
¾ FDA does not regulate independent and non-promotional
industry-supported activities
¾ Determination of independence includes:
ƒ Control of content
ƒ Inclusion of promotional material
ƒ Single-product marketing vs treatment options
ƒ Source of invitation lists
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8
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The Main Points of the Code are:
? General Interaction: Interaction should focus on informing the
? Entertainment: Interaction should not include
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PhRMA Code on Interactions with
professional about scientifc and educational information and
supporting scientifc medical research and education to maximize
The Main Points of the Code are:
patient benefts.
entertainment. Interaction should occur at a venue conducive to
providing scientifc or educational information. Specifcally, this
means no "dine and dash," no entertainment, and no recreational
events (e.g., sporting events or spa visits).
PhRMA Code on Interactions with
Healthcare Professionals
Healthcare Professionals
¾ General Interaction: Interaction should focus on informing the
professional about scientific and educational information and
supporting scientific medical research and education to maximize
patient benefits.
MINTzLEvIN
Mir rr. Levirv Cc n ix l r•I is Gi.c
¾ Entertainment: Interaction should not include
entertainment. Interaction should occur at a venue conducive to
providing scientific or educational information. Specifically, this
means no “dine and dash,” no entertainment, and no recreational
events (e.g., sporting events or spa visits).
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9
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Healthcare Professionals (cont.)
the conference sponsor but should not fund individual
participants. Sponsor may in turn provide grants to
individuals to participate, or to reduce the overall registration
fees for all attendees.
PhRMA Code on Interactions with
? Continuing Education: Companies can provide support to
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PhRMA Code on Interactions with
Healthcare Professionals (cont.)
¾ Continuing Education: Companies can provide support to
the conference sponsor but should not fund individual
participants. Sponsor may in turn provide grants to
individuals to participate, or to reduce the overall registration
fees for all attendees.
MINTZ L,EUIN
Mir rr. I,evirv Ccn i? l r•iziiis Gi
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? Consultants: Legitimate consulting or advisory arrangements are
appropriate if retention of professionals are based on their expertise and
retention is made for no more than needed for the specifc program.
However, token consulting arrangements should not be used to justify
payments to professionals.
? Educational and Healthcare Practice-Related Items: Educational and
practice-related items may be provided to professionals, but should be for
the health care benefit of patients and of less than substantial value ($100 or
less). Items for the personal benefit of the professional should not be
offered or distributed.
? The Code became effective on July 2002.
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PhRMA Code on Interactions with
Healthcare Professionals (cont.)
PhRMA Code on Interactions with
Healthcare Professionals (cont.)
¾ Consultants: Legitimate consulting or advisory arrangements are
appropriate if retention of professionals are based on their expertise and
retention is made for no more than needed for the specific program.
However, token consulting arrangements should not be used to justify
payments to professionals.
¾ Educational and Healthcare Practice-Related Items: Educational and
practice-related items may be provided to professionals, but should be for
the health care benefit of patients and of less than substantial value ($100 or
less). Items for the personal benefit of the professional should not be
offered or distributed.
MINTZ L,EUIN
MiN rr. I,I VIN C Ol iN I r•RRIS U O
¾ The Code became effective on July 2002.
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11
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with Health Care Professionals
ƒ “…individuals or entities that purchase, lease, recommend,
AdvaMed Code of Ethics for Interactions
Key points:
? Defines "Health Care Professionals" as:
¦ "...individuals or entities that purchase, lease, recommend,
¾ Defines “Health Care Professionals” as:
use, arrange for purchase or lease of, or prescribe Members'
medical technology products in the United States "
? Member-Sponsored Product Training and Education - Must be
held in settings conducive to education and training; moderate/low
value meals and receptions; no other entertainment for HCP
attendees; reasonable travel and lodging for HCP attendees; cannot
pay for guests of HCPs or others without bona fde professional
interest in the meeting.
Key points:
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AdvaMed Code of Ethics for Interactions
with Health Care Professionals
use, arrange for purchase or lease of, or prescribe Members’
medical technology products in the United States ”
X
MINI r. LE VIN COI IN l riuiis G.OV
¾ Member-Sponsored Product Training and Education – Must be
held in settings conducive to education and training; moderate/low
value meals and receptions; no other entertainment for HCP
attendees; reasonable travel and lodging for HCP attendees; cannot
pay for guests of HCPs or others without bona fide professional
interest in the meeting.
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12
T FN
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with Health Care Professionals (cont.)
? Supporting Third Party Educational Conferences - Members
may provide funds to conference sponsor to reduce costs or allow
HCPs-in-training to attend if meeting promotes scientific, educational
or policy activities, and training institution or conference sponsors
selects attendees. Such funds may be provided for modest meal and
hospitality of HCP attendees, HCP bona fde faculty expenses,
advertisements and booth space.
? Sales and Promotional Meetings - Meetings with HCPs on
product features, contract negotiations, sales terms;
occasional/infrequent meals and receptions for HCP attendees;
reasonable travel costs for HCP attendees; not appropriate to pay for
meals or other hospitality for guests of HCPs.
¾ Supporting Third Party Educational Conferences – Members
may provide funds to conference sponsor to reduce costs or allow
HCPs-in-training to attend if meeting promotes scientific, educational
or policy activities, and training institution or conference sponsors
selects attendees. Such funds may be provided for modest meal and
hospitality of HCP attendees, HCP bona fide faculty expenses,
advertisements and booth space.
AdvaMed Code of Ethics for Interactions
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AdvaMed Code of Ethics for Interactions
with Health Care Professionals (cont.)
MINTzLEvIN
MINI r. LE VIN COI IN l riuiis Gi.OV
¾ Sales and Promotional Meetings – Meetings with HCPs on
product features, contract negotiations, sales terms;
occasional/infrequent meals and receptions for HCP attendees;
reasonable travel costs for HCP attendees; not appropriate to pay for
meals or other hospitality for guests of HCPs.
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13
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with Health Care Professionals (cont.)
? Arrangements with Consultants - Members may pay for
reasonable compensation for services, and reasonable/ actual
expenses incurred;
¦ B ona fide consulting arrangements are:
• In writing, with services specifed, and must be signed;
• Compensation is consistent with fair market value;
• Legitimate purpose and need for services identifed in
• Selection based on consultant's qualifcations and expertise;
• Venues of meetings are modest;
• Written protocol for research services
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advance;
MINTzLEvIN
MINI r. I,EVIN COI IN l riuiis GLOVS
¾ Arrangements with Consultants – Members may pay for
reasonable compensation for services, and reasonable/actual
expenses incurred;
ƒ Bona fide consulting arrangements are:
• In writing, with services specified, and must be signed;
• Compensation is consistent with fair market value;
• Legitimate purpose and need for services identified in
advance;
• Selection based on consultant’s qualifications and expertise;
• Venues of meetings are modest;
• Written protocol for research services
AdvaMed Code of Ethics for Interactions
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AdvaMed Code of Ethics for Interactions
with Health Care Professionals (cont.)
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14
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¾ Gifts – Modest, occasional gifts allowed if gift benefits patients or
serves genuine education function and gift has fair market value of
less than $100 (exceptions: text books and anatomical models). May
occasionally provide branded promotional items of minimal value; no
cash or cash equivalents; legitimate practice of providing samples and
product evaluations.
¾ Grants and Charitable Donations – Members may make donations
for charitable purpose if made to charitable organization in support
of: independent medical research, indigent care, patient education
and public education, sponsorship of events where proceeds are
charitable; all donations must be documented.
MINTzLEvIN
MINT r. LE VIN COI IN l riuiis G .O
¾ AdvaMed Code became effective January 2004.
AdvaMed Code of Ethics for Interactions
with Health Care Professionals (cont.)
? Gifts - Modest, occasional gifts allowed if gift benefits patients or
serves genuine education function and gift has fair market value of
less than $100 (exceptions: text books and anatomical models). May
occasionally provide branded promotional items of minimal value; no
cash or cash equivalents; legitimate practice of providing samples and
product evaluations.
? Grants and Charitable Donations - Members may make donations
for charitable purpose if made to charitable organization in support
of: independent medical research, indigent care, patient education
and public education, sponsorship of events where proceeds are
charitable; all donations must be documented.
? AdvaMed Code became effective January 2004.
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AdvaMed Code of Ethics for Interactions
with Health Care Professionals (cont.)
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¾ Ethical Opinion and Guidelines Related to CME
¾ AMA Cautions Physicians to:
ƒ Assess educational value of the program and attend
program on that basis
ƒ Choose programs offered by accredited sponsors
ƒ Don’t accept direct subsidies (vs. through sponsor) to
attend program or for travel
¾ Became effective June 2002
MINTZ LEUIN ,
M(N-rr. I,BVIN GM N I?PRRIS (j1 .O
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AMA Guidelines
? Ethical Opinion and Guidelines Related to CME
? AMA Cautions Physicians to:
program on that basis
¦ Choose programs offered by accredited sponsors
¦ Don't accept direct subsidies (vs. through sponsor) to
attend program or for travel
¦ Assess educational value of the program and attend
? Became effective June 2002
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AMA Guidelines
16
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? OIG and Industry Guidance
¾ OIG and Industry Guidance
? Fraud and Abuse Enforcement Activity
? Medicare Part D
©Copy=right, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., 2007
non-exclusive license to American Bar Association
OUTLINE
¾ Fraud and Abuse Enforcement Activity
OUTLINE
¾ Medicare Part D
MINTzLEvIN
MINI r. I,EVIN COI IN l riuiis Gi.OVS
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Manufacturers/Benefit Managers
? Price concessions, including volume discounts, prompt pay
discounts, cash discounts, rebates, up-front payments, short-
dated product discounts, and nominally priced or free
products
? Educational, clinical, research or unrestricted grants or
sponsorships
? Sponsorship of speaking engagements, honoraria, meetings,
symposia, case study programs, exhibits and other similar
events
? Paid consultancies, advisory boards or research panels
¾ Price concessions, including volume discounts, prompt pay
discounts, cash discounts, rebates, up-front payments, shortdated product discounts, and nominally priced or free
products
¾ Educational, clinical, research or unrestricted grants or
sponsorships
¾ Sponsorship of speaking engagements, honoraria, meetings,
symposia, case study programs, exhibits and other similar
events
¾ Paid consultancies, advisory boards or research panels
MINTZ LEUIN
MINrr. IA-yIN(_;OIIN I?PIRRRIS(1l
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Allegations Involving Pharmaceutical
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Allegations Involving Pharmaceutical
Manufacturers/Benefit Managers
18
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? Inducements structured to avoid new best price of drugs
? Free or low-cost continuing medical education programs or
tuition payments
? Gifts, luxury trips, parties, and entertainment
? Free or low cost practice-support services, such as
reimbursement guarantees, audit, accounting, third-party
payor, billing assistance services
? Compensation for detailing, time and travel, marketing,
switching, or converting from a competitor's product
Allegations Involving Pharmaceutical
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Allegations Involving Pharmaceutical
Manufacturers/PBMs (cont.)
Manufacturers/PBMs (cont.)
¾ Inducements structured to avoid new best price of drugs
¾ Free or low-cost continuing medical education programs or
tuition payments
¾ Gifts, luxury trips, parties, and entertainment
¾ Free or low cost practice-support services, such as
reimbursement guarantees, audit, accounting, third-party
payor, billing assistance services
¾ Compensation for detailing, time and travel, marketing,
switching, or converting from a competitor’s product
MINTzLEvIN
MINI r. I EVIN COI IN l riuiis G .OV
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? Items to gain access to physician's offces, such as meals and
refreshments (often called "access tools") and preceptors
? Free medical and offce equipment, including computers
? Charitable contributions
? Marketing of off-label uses
? Ghost-written papers
? Professional courtesies or debt forgiveness
? Equity in new enterprises or in new products
Allegations Involving Pharmaceutical
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Allegations Involving Pharmaceutical
Manufacturers/PBMs (cont.)
MINTZ L,EUIN
MI\IZ I ,I VIN(-()I IN I?FRRIS(;IOVS
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Manufacturers/PBMs (cont.)
¾ Items to gain access to physician’s offices, such as meals and
refreshments (often called “access tools”) and preceptors
¾ Free medical and office equipment, including computers
¾ Charitable contributions
¾ Marketing of off-label uses
¾ Ghost-written papers
¾ Professional courtesies or debt forgiveness
¾ Equity in new enterprises or in new products
20
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Manufacturers/PBMs (cont.)
? Educational grants
? Free or heavily underwritten disease management programs
? Payment for switching
? Various forms of inducements related to formulary status
¾
¾
¾
¾
Allegations Involving Pharmaceutical
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Allegations Involving Pharmaceutical
Manufacturers/PBMs (cont.)
Educational grants
Free or heavily underwritten disease management programs
Payment for switching
Various forms of inducements related to formulary status
MINTzLEvIN
MINI r. I,EVIN COI IN l riuiis Gi.OVS
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United States ex rel. Franklin v. Parke-Davis,
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Pfizer/Parke-Davis/Warner Lambert
(D.Mass 2001) (Attached) - allegations:
Pfizer/Parke-Davis/Warner Lambert
? "Medical liaisons" employed by sales division of predecessor
Warner Lambert
o made off-label claims related to indications and dosing
(D.Mass 2001) (Attached) – allegations:
o misrepresented credentials
? Physicians coached to hide off-label nature of prescription
? Sham clinical studies with no scientifc value
> Payments for consultants, preceptors, speakers bureau, access
to patient records, gifts (Olympic tickets)
United States ex rel. Franklin v. Parke-Davis, 147 F.Supp.2d 39
¾“Medical liaisons” employed by sales division of predecessor
Warner Lambert
o misrepresented credentials
o made off-label claims related to indications and dosing
¾Physicians coached to hide off-label nature of prescription
¾Sham clinical studies with no scientific value
MINTzLEvIN
MINI r. I,EVIN COI IN l riuiis Gi.OVS
¾Payments for consultants, preceptors, speakers bureau, access
to patient records, gifts (Olympic tickets)
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147 F.Sup
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United States ex rel. Franklin v. Parke-Davis (cont.)
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United States ex rel. Franklin v. Parke-Davis (cont.)
Pfizer/Parke-Davis/Warner Lambert (cont.)
? Decision on 9(b) motion to dismiss by Parke-Davis for failure
to plead fraud with particularity
? Neurontin- has many recognized off-label uses (pain,
epilepsy) - 50% of sales
? Accupril - approved for hypertension
in April 2002
? Note: Amended Complaint subsequently fled, and unsealed
Pfizer/Parke-Davis/Warner Lambert (cont.)
¾ Decision on 9(b) motion to dismiss by Parke-Davis for failure
to plead fraud with particularity
¾ Neurontin– has many recognized off-label uses (pain,
epilepsy) – 50% of sales
¾ Accupril – approved for hypertension
¾ Note: Amended Complaint subsequently filed, and unsealed
in April 2002
MINTzLEvIN
MINI r. LE VIN COI IN l riuiis (ii .OVS
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Pfizer/Parke-Davis/Warner Lambert (cont.)
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United States ex rel. Franklin v. Parke-Davis (cont.)
Court found that scheme to promote off-label uses is actionable
under the False Claims Act ("FCA")
Pfizer/Parke-Davis/Warner Lambert (cont.)
• Company concedes that off-label prescriptions are not
reimbursable by Medicaid
• Complaint suffciently alleges "a fraudulent marketing
campaign in which kickbacks and unlawful and misleading
marketing were allegedly used to encourage doctors to
increase their use of Neurontin for unapproved
purposes." (Emphasis added)
statements regarding these drugs and use of kickbacks
• Material misrepresentation to obtain a beneft - false
United States ex rel. Franklin v. Parke-Davis (cont.)
MINTzLEvIN
MINI r. LE VIN COI IN l riuiis Gi.OV
Court found that scheme to promote off-label uses is actionable
under the False Claims Act (“FCA”)
• Company concedes that off-label prescriptions are not
reimbursable by Medicaid
• Complaint sufficiently alleges “a fraudulent marketing
campaign in which kickbacks and unlawful and misleading
marketing were allegedly used to encourage doctors to
increase their use of Neurontin for unapproved
purposes.” (Emphasis added)
• Material misrepresentation to obtain a benefit – false
statements regarding these drugs and use of kickbacks
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Pfizer/Parke-Davis/Warner Lambert (cont.)
- Regulatory violation not actionable under the FCA
- No allegation that Parke-Davis caused the submission of
United States ex rel. Franklin v. Parke-Davis (cont.)
United States ex rel. Franklin v. Parke-Davis (cont.)
? Theory that kickback violation is actionable under FCA requires a
showing that Parke-Davis caused or induced doctors and/or
pharmacists to fle a false or fraudulent certifcation regarding
compliance with the Anti-Kickback Statute
? Court rejects allegation under FCA that Parke-Davis engaged
physicians to perform clinical trials where drugs were charged in
violation of § 312.7
Pfizer/Parke-Davis/Warner Lambert (cont.)
false claims
¾ Theory that kickback violation is actionable under FCA requires a
showing that Parke-Davis caused or induced doctors and/or
pharmacists to file a false or fraudulent certification regarding
compliance with the Anti-Kickback Statute
¾ Court rejects allegation under FCA that Parke-Davis engaged
physicians to perform clinical trials where drugs were charged in
violation of § 312.7
- Regulatory violation not actionable under the FCA
- No allegation that Parke-Davis caused the submission of
false claims
MINTzLEvIN
MINI r. LE VIN COI IN l riuiis (ii .OV
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Pfizer/Parke-Davis/Warner Lambert (cont.)
¦ Resolution:
cases as well as state civil cases
¦ Whistleblower was a Ph.D. microbiologist employed as Parke-
Davis medical liaison -- $26.4 million, plus attorneys fees.
? Pfizer/Warner Lambert Settlement (2004)
Pfizer/Parke-Davis/Warner Lambert (cont.)
$430 million to settle federal criminal and civil
• Criminal plea by Warner Lambert for two counts of
$240,000,000 criminal fne
distribution for unapproved uses (off-label) & misbranding
•
$190,000,000 (plus interest) civil fne to federal and state
(Attached)
•
governments
M1NTZ LEVIN
MINI r. I,EVIN COI IN l riuiis GU)VS
¾ Pfizer/Warner Lambert Settlement (2004)
ƒ Resolution: $430 million to settle federal criminal and civil
cases as well as state civil cases
• Criminal plea by Warner Lambert for two counts of
distribution for unapproved uses (off-label) & misbranding
(Attached)
• $240,000,000 criminal fine
• $190,000,000 (plus interest) civil fine to federal and state
governments
ƒ Whistleblower was a Ph.D. microbiologist employed as ParkeDavis medical liaison -- $26.4 million, plus attorneys fees.
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Pfizer/Parke-Davis/Warner Lambert (cont.)
? As part of this settlement, Pfzer agreed to an updated CIA (May
(0 Copyright, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., 2007
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2004) available on the OIG's website at:
www. oig. hhs.gov/fraud/cia/ndex. html
• Policies and Procedures
• Specifc Training
• Independent Review Organization specifc engagement for
• "Promotional and Product Services Transactional Review"
¦ Specifc requirements related to off-label promotion
Pfizer/Parke-Davis/Warner Lambert (cont.)
"Promotional and Product Services Systems Review"
(Attachment C).
by IRO (Attachment D)
M1NTZ LEVIN
MINI r. I,EVIN COI IN l riuiis GU)VS
¾ As part of this settlement, Pfizer agreed to an updated CIA (May
2004) available on the OIG’s website at:
www.oig.hhs.gov/fraud/cia/index.html
ƒ Specific requirements related to off-label promotion
• Policies and Procedures
• Specific Training
• Independent Review Organization specific engagement for
“Promotional and Product Services Systems Review”
(Attachment C).
• “Promotional and Product Services Transactional Review”
by IRO (Attachment D)
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Pfizer/Parke-Davis/Warner Lambert (cont.)
© Copyright, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., 2007
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Parke-Davis/Warner Lambert/Pfzer (cont.)
?Warner Lambert Sentencing Memorandum (June 2, 2004)
53 pages
(Attached)
¦
¦ Inadequate directions for use
¦ Distribution for unapproved use
¦ Misbranding/ false or misleading labeling or advertising
¦ Encouraging off-label prescribing
Pfizer/Parke-Davis/Warner Lambert (cont.)
Parke-Davis/Warner Lambert/Pfizer (cont.)
¾Warner Lambert Sentencing Memorandum (June 2, 2004)
(Attached)
ƒ 53 pages
ƒ Inadequate directions for use
ƒ Distribution for unapproved use
ƒ Misbranding/false or misleading labeling or advertising
ƒ Encouraging off-label prescribing
MINTZ L,EUIN
Mir rr. Levirv Cc n i? l r•ii
;??u Pc mr.c
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Warner Lambert Sentencing Memorandum (cont.)
Pfizer/Parke-Davis/Warner Lambert (cont.)
Warner Lambert Sentencing Memorandum (cont.)
"Medical Liaisons, this is [the northeast Associate Medical
Director ]. I am calling in regard to the-- you know, there's a
Neurontin push that's supposed to be on.
to do is focus on Neurontin. When we get out there, we want to
kick some ass on Neurontin, we want to sell Neurontin on pain.
All right? And monotherapy and everything that we can talk
about, that's what we want to do.
don't know if you guys are embarrassed. But I'm embarrassed
about where we are with Neurontin. We've got to take it into
our own hands and really kick some ass on it, all right? Let's do
Pfizer/Parke-Davis/Warner Lambert (cont.)
it up." At 11
...So, what we need
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`Cause I'm embarrassed. I
M1NTZ LEVIN
MINI r. I,EVIN COI IN l riuiis GU)VS
“Medical Liaisons, this is [the northeast Associate Medical
Director ]. I am calling in regard to the-- you know, there’s a
Neurontin push that’s supposed to be on. …So, what we need
to do is focus on Neurontin. When we get out there, we want to
kick some ass on Neurontin, we want to sell Neurontin on pain.
All right? And monotherapy and everything that we can talk
about, that’s what we want to do. ‘Cause I’m embarrassed. I
don’t know if you guys are embarrassed. But I’m embarrassed
about where we are with Neurontin. We’ve got to take it into
our own hands and really kick some ass on it, all right? Let’s do
it up.” At 11
29
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Pfizer/Parke-Davis/Warner Lambert (cont.)
Warner Lambert Sentencing Memorandum (cont.)
"...the 1997 Neurontin Strategic Plan references `increase
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, off label uses grew from approximately 15% of all uses
in 1994, the first year Neurontin was marketed, to 94%
in 2002." At 13
in emerging uses' as both an issue and an opportunity.
`Primary marketing objectives for Neurontin in 1997
will be to grow the use of the brand of epilepsy
indications and to maximize Neurontin opportunities in
emerging applications' (emphasis supplied)." At 15
Pfizer/Parke-Davis/Warner Lambert (cont.)
Warner Lambert Sentencing Memorandum (cont.)
“…off-label uses grew from approximately 15% of all uses
in 1994, the first year Neurontin was marketed, to 94%
in 2002.” At 13
MINTzLEvIN
MINI r. LE VIN COI IN l riuiis G .OVS
“…the 1997 Neurontin Strategic Plan references ‘increase
in emerging uses’ as both an issue and an opportunity.
… ‘Primary marketing objectives for Neurontin in 1997
will be to grow the use of the brand of epilepsy
indications and to maximize Neurontin opportunities in
emerging applications’ (emphasis supplied).” At 15
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Warner Lambert Sentencing Memorandum (cont.)
Pfizer/Parke-Davis/Warner Lambert (cont.)
Warner Lambert Sentencing Memorandum (cont.)
"...Parke-Davis' management considered whether it should
seek FDA approval [but decided not to seek such approval] of
additional uses for Neurontin beyond adjunctive anti-seizure
treatment. These uses included such areas as pain, pediatric
use, psychological disorders, ALS (amyotrophic lateral sclerosis
or Lou Gehrig's disease) and, especially, monotherapy for
epilepsy. Among the factors considered were the potential
market value of the use both with and without FDA approval,
the likelihood of obtaining FDA approval, the short patent life
of Neurontin and the impact of broader Neurontin indications
Pfizer/Parke-Davis/Warner Lambert (cont.)
on a new drug being developed." At 17
MINTzLEvIN
MINI r. LE VIN COI IN l riuiis Gi.OVS
“…Parke-Davis’ management considered whether it should
seek FDA approval [but decided not to seek such approval] of
additional uses for Neurontin beyond adjunctive anti-seizure
treatment. These uses included such areas as pain, pediatric
use, psychological disorders, ALS (amyotrophic lateral sclerosis
or Lou Gehrig’s disease) and, especially, monotherapy for
epilepsy. Among the factors considered were the potential
market value of the use both with and without FDA approval,
the likelihood of obtaining FDA approval, the short patent life
of Neurontin and the impact of broader Neurontin indications
on a new drug being developed.” At 17
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Pfizer/Parke-Davis/Warner Lambert (cont.)
Warner Lambert Sentencing Memorandum (cont.)
"Parke-Davis promoted Neurontin for a variety of pain
types, including painful diabetic neuropathy, post-herpetic
neuropathy, reflex sympathetic dystrophy and migraine
headaches, among others." At 20
"Parke-Davis also promoted Neurontin for a variety of
psychiatric conditions, including bipolar disorder, anxiety,
social phobia and general mood stabilization..." At 22
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Pfizer/Parke-Davis/Warner Lambert (cont.)
Warner Lambert Sentencing Memorandum (cont.)
“Parke-Davis promoted Neurontin for a variety of pain
types, including painful diabetic neuropathy, post-herpetic
neuropathy, reflex sympathetic dystrophy and migraine
headaches, among others.” At 20
MINTzLEvIN
MINI r. I d;VIN COI IN l riuiis (ii .OVS
“Parke-Davis also promoted Neurontin for a variety of
psychiatric conditions, including bipolar disorder, anxiety,
social phobia and general mood stabilization…” At 22
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Pfizer/Parke-Davis/Warner Lambert (cont.)
Warner Lambert Sentencing Memorandum (cont.)
Neurontin prescribed, even as the company unsuccessfully
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"All claims by Parke-Davis as to the effectiveness of
Neurontin at doses above 1800 mg./day were off-label and
constituted misbranding under the FD&C Act. The
evidence shows that Parke-Davis made such claims as part
of a concerted effort to get doctors to increase the level of
Pfizer/Parke-Davis/Warner Lambert (cont.)
sought approval for a higher dose." At 25
Warner Lambert Sentencing Memorandum (cont.)
“All claims by Parke-Davis as to the effectiveness of
Neurontin at doses above 1800 mg./day were off-label and
constituted misbranding under the FD&C Act. The
evidence shows that Parke-Davis made such claims as part
of a concerted effort to get doctors to increase the level of
Neurontin prescribed, even as the company unsuccessfully
sought approval for a higher dose.” At 25
MINTzLEvIN
MINTZ I d;VIN COI IN l r.iuiis (ii .OV
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Pfizer/Parke-Davis/Warner Lambert (cont.)
Warner Lambert Sentencing Memorandum (cont.)
planning documents and which it used to achieve its goal
of increasing off-label use of Neurontin were the
following:
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"Among the key tactics Parke-Davis set out in its
"(1) Encouraging sales representatives to provide one-on-one
"(2) Utilizing medical liaisons, who represented themselves, often
Pfizer/Parke-Davis/Warner Lambert (cont.)
sales pitches ('details') to physicians about off-label uses of
Neurontin;
falsely, as neutral scientific experts in the area of a particular
drug, to promote off-label uses for Neurontin, working in
tandem with the sales representatives to directly sell
Neurontin to physicians for off-label uses;
Warner Lambert Sentencing Memorandum (cont.)
“Among the key tactics Parke-Davis set out in its
planning documents and which it used to achieve its goal
of increasing off-label use of Neurontin were the
following:
MINTZ LEUIN
MINI r. LE VIN COI IN l riuiis Gi.OVS
“(1) Encouraging sales representatives to provide one-on-one
sales pitches (‘details’) to physicians about off-label uses of
Neurontin;
“(2) Utilizing medical liaisons, who represented themselves, often
falsely, as neutral scientific experts in the area of a particular
drug, to promote off-label uses for Neurontin, working in
tandem with the sales representatives to directly sell
Neurontin to physicians for off-label uses;
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Warner Lambert Sentencing Memorandum (cont.)
(cont.)
Pfizer/Parke-Davis/Warner Lambert (cont.)
Warner Lambert Sentencing Memorandum (cont.)
(cont.)
"(3) Paying physicians to allow a sales representative to see
patients with the doctor and to participate in discussing the
treatment plan;
provision of trips, hotel rooms, dinners and other benefits, to
attend a variety of meetings termed `consultant' or 'advisory'
meetings or `speaker bureau trainings' in which doctors
received presentations about off-label uses of Neurontin;
"(4) Paying physicians, through both direct payments, and the
Pfizer/Parke-Davis/Warner Lambert (cont.)
“(3) Paying physicians to allow a sales representative to see
patients with the doctor and to participate in discussing the
treatment plan;
“(4) Paying physicians, through both direct payments, and the
provision of trips, hotel rooms, dinners and other benefits, to
attend a variety of meetings termed ‘consultant’ or ‘advisory’
meetings or ‘speaker bureau trainings’ in which doctors
received presentations about off-label uses of Neurontin;
MINTzLEvIN
MINI r. LE VIN COI IN l riuiis (ii .OV
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Warner Lambert Sentencing Memorandum (cont.)
(cont.)
“(5) Implementing frequent teleconferences in which
doctors were paid by Parke-Davis to speak about
Neurontin on off-label topics to other doctors; and
MINTzLEvIN
MINI r. L VIN COI IN l riuiis G .OVS
“(6) Sponsoring ostensibly independent ‘medical
education’ events on off-label Neurontin uses
where there was actually extensive input from
Parke-Davis regarding topics, speakers, content,
and participants.” At 26-27
Pfizer/Parke-Davis/Warner Lambert (cont.)
Warner Lambert Sentencing Memorandum (cont.)
(cont.)
"(5) Implementing frequent teleconferences in which
doctors were paid by Parke-Davis to speak about
Neurontin on off-label topics to other doctors; and
education' events on off-label Neurontin uses
where there was actually extensive input from
Parke-Davis regarding topics, speakers, content,
and participants." At 26-27
"(6) Sponsoring ostensibly independent `medical
Pfizer/Parke-Davis/Warner Lambert (cont.)
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October 26, 2006 settlement N.D. Cal.
? Criminal Information
? Deferred Prosecution Agreement
? $36.9 million civil settlement
? Five year Corporate Integrity Agreement
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Intermune, Inc. Settlement
¾ Criminal Information
¾ Deferred Prosecution Agreement
Intermune, Inc. Settlement
October 26, 2006 settlement N.D. Cal.
¾ $36.9 million civil settlement
¾ Five year Corporate Integrity Agreement
MINTzLEvIN
MINI r. I,EVIN COI IN l riuiis Gi.OVS
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? Uncontested facts -- Deferred Prosecution Agreement
osteopetrosis and one other condition
Vast majority of sales were for ideopathic pulmonary fbrosis
¦ Actimune (interferon drug) approved for severe malignant
¦
(IPF)
¦ Company conducted a phase III clinical trial for IPF
indication, but results were not statistically signifcant.
¦ Results presented to FDA
¦ Company went ahead and marketed Actimune for IPF making
claims using statistical comparisons
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Intermune, Inc. cont.
Intermune, Inc. cont.
¾ Uncontested facts -- Deferred Prosecution Agreement
FDA needed more work
MINTZ LEUIN
MINT r. LE VIN COI IN l riuiis G .OV
ƒ Actimune (interferon drug) approved for severe malignant
osteopetrosis and one other condition
ƒ Vast majority of sales were for ideopathic pulmonary fibrosis
(IPF)
ƒ Company conducted a phase III clinical trial for IPF
indication, but results were not statistically significant.
ƒ Results presented to FDA → FDA needed more work
ƒ Company went ahead and marketed Actimune for IPF making
claims using statistical comparisons
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38
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Intermune, Inc. cont.
¾ Past cooperation, including
ƒ disclosed results of internal investigation and
ƒ made employees available, etc.
¾ Compliance changes instituted prior to investigation
¾ Full cooperation for two years
ƒ Disclosure of information
ƒ Documents
ƒ Reasonable access to facilities and employees
¾ Not make statements contradicting stipulated facts
Obligations under Deferred Prosecution Agreement
¦ disclosed results of internal investigation and
¦ made employees available, etc.
¦ Disclosure of information
¦ Documents
¦ Reasonable access to facilities and employees
Obligations under Deferred Prosecution Agreement
? Past cooperation, including
? Compliance changes instituted prior to investigation
? Full cooperation for two years
? Not make statements contradicting stipulated facts
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Intermune, Inc. cont.
MINTzLEvIN
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39
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? In civil settlement, government alleges that the use of
Actimmune for IPF was not a "medically accepted
indication"
? CIA provisions of interest related to off-label
¦ Policies and procedures
¦ Specifc training
¦ IRO Promotional and Product Services Engagement
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Intermune, Inc. cont.
ƒ Policies and procedures
ƒ Specific training
ƒ IRO Promotional and Product Services Engagement
Intermune, Inc. cont.
¾ In civil settlement, government alleges that the use of
Actimmune for IPF was not a “medically accepted
indication”
¾ CIA provisions of interest related to off-label
MINTzLEvIN
MINI r. I d;VIN Coi IN l riuiis G .OVS
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40
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? OIG and Industry Guidance
? Fraud and Abuse Enforcement Activity
¾ OIG and Industry Guidance
? Medicare Part D
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OUTLINE
¾ Fraud and Abuse Enforcement Activity
OUTLINE
¾ Medicare Part D
MIN
MINI r. I,EVIN COI IN l riuiis GLOVS
?
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41
T
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covered drug as:
¦ A drug that may be dispensed only upon a prescription and that is
Regulatory Authority and Guidance
Regulatory Authority and Guidance
? Section 1860D-2(e) (1) of the Social Security Act defnes a Part D
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Medicare Part D
Approved for safety and effectiveness as a prescription drug under
the Federal Food, Drug, and Cosmetic Act
Commercially used or sold in the United States ... or which is
identical, similar, or related to such a drug, and which has not been
the subject of a final determination that it is a "new drug"
Described in section 107 (c) (3) of the Drug Amendments of 1962
and for which there is a compelling justifcation for its medical
need, and for which it has not been determined that the drug is
less than effective for some or all conditions of use prescribed,
recommended, or suggested in its labeling
¾ Section 1860D-2(e)(1) of the Social Security Act defines a Part D
covered drug as:
ƒ A drug that may be dispensed only upon a prescription and that is
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Medicare Part D
MINTzLEvIN
MINI r. I,EVIN COI IN l riuiis Gi.OVS
– Approved for safety and effectiveness as a prescription drug under
the Federal Food, Drug, and Cosmetic Act
– Commercially used or sold in the United States …or which is
identical, similar, or related to such a drug, and which has not been
the subject of a final determination that it is a “new drug”
– Described in section 107(c)(3) of the Drug Amendments of 1962
and for which there is a compelling justification for its medical
need, and for which it has not been determined that the drug is
less than effective for some or all conditions of use prescribed,
recommended, or suggested in its labeling
42
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associated with the injection of insulin (as defned in
regulations of the Secretary), and such term includes a vaccine
licensed under section 351 of the Public Health Service Act
and any use of a covered part D drug for a medically accepted
indication (as defned in section 1927(k)(6)).
¦ A biological product ... or insulin ... and medical supplies
Medicare Part D (cont.)
Medicare Part D (cont.)
OR
ƒ A biological product …or insulin … and medical supplies
associated with the injection of insulin (as defined in
regulations of the Secretary), and such term includes a vaccine
licensed under section 351 of the Public Health Service Act
and any use of a covered part D drug for a medically accepted
indication (as defined in section 1927(k)(6)).
OR
MINTzLEvIN
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? 42 C.F.R. § 423.100: Covered Part D drug means a Part D drug
coverage determination or appeal and obtained in a network
pharmacy.
"We recognize the value of off label prescribing, particularly
with regard to certain medical conditions ... physicians and
other prescribers [are not precluded] from prescribing drugs
for off label indications, provided the drug is prescribed for a
"medically accepted indication" as defned in section
1927
that is included in a Part D plan's formulary as a result of a
? The Preamble to 42 C.F.R. § 423 declares:
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Medicare Part D (cont.)
Medicare Part D (cont.)
(k)(6) of the Act."
¾ 42 C.F.R. § 423.100: Covered Part D drug means a Part D drug
that is included in a Part D plan’s formulary as a result of a
coverage determination or appeal and obtained in a network
pharmacy.
MINTzLEvIN
MINTZ I,EVIN COI IN l r.iuiis GLOVS
¾ The Preamble to 42 C.F.R. § 423 declares:
“We recognize the value of off label prescribing, particularly
with regard to certain medical conditions…physicians and
other prescribers [are not precluded] from prescribing drugs
for off label indications, provided the drug is prescribed for a
“medically accepted indication” as defined in section
1927(k)(6) of the Act.”
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"Any use for a covered outpatient drug which is approved under
the Federal Food, Drug, and Cosmetic Act, or the use of
which is supported by one or more citations included or
approved for inclusion in any of the [following] compendia:
[(a) American Hospital Formulary Service Drug Information,
(b) United States Pharmacopeia-Drug Information; or (c) the
DRUGDEX Information System."
¾ Medically Accepted Indication:
? Medically Accepted Indication:
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Medicare Part D (cont.)
Medicare Part D (cont.)
“Any use for a covered outpatient drug which is approved under
the Federal Food, Drug, and Cosmetic Act, or the use of
which is supported by one or more citations included or
approved for inclusion in any of the [following] compendia:
[(a) American Hospital Formulary Service Drug Information,
(b) United States Pharmacopeia-Drug Information; or (c) the
DRUGDEX Information System.”
MINTzLEvIN
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AHFS's website (http://www.ashp.org/ahfs/print/ahfs-di.cfm) describes
the Drug Information book as follows:
500 medical scientists, physicians, pharmacists, pharmacologists, and
other professionally qualifed individuals that goes beyond FDA-
approved labeling.
"Inside fnd:
? Expert advice and peer reviewed by over 500 medical scientists,
physicians, pharmacists, pharmacologists, and other professionally
qualifed individuals
? Over 40,000 represented medicines and over 100,000 drug products
? Off-label and labeled uses"
"[Contains information from medical literature and expert advice from over
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Medicare Part D (cont.)
Medicare Part D (cont.)
MINTzLEvIN
MINI r. I d;VIN Coi IN l riuiis Gi.OV
AHFS’s website (http://www.ashp.org/ahfs/print/ahfs-di.cfm) describes
the Drug Information book as follows:
“[Contains information from medical literature and expert advice from over
500 medical scientists, physicians, pharmacists, pharmacologists, and
other professionally qualified individuals that goes beyond FDAapproved labeling.
“Inside find:
¾ Expert advice and peer reviewed by over 500 medical scientists,
physicians, pharmacists, pharmacologists, and other professionally
qualified individuals
¾ Over 40,000 represented medicines and over 100,000 drug products
¾ Off-label and labeled uses”
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additional clinical indications that do not make it into any of the
three approved sources. These include:
¦ Peer review articles in medical journals
¦ Clinical trial data
? These sources do not qualify as medically accepted indications
? There is no realistic way to monitor such off-label prescribing.
? There are a substantial number of other authorities to support
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Medicare Part D (cont.)
Medicare Part D (cont.)
¾ There are a substantial number of other authorities to support
additional clinical indications that do not make it into any of the
three approved sources. These include:
ƒ Peer review articles in medical journals
ƒ Clinical trial data
¾ These sources do not qualify as medically accepted indications
¾ There is no realistic way to monitor such off-label prescribing.
MINTzLEvIN
MINI r. I,EVIN COI IN l riuiis Gi.OVS
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Medicare Part D (cont.)
¦ "Plans have the fexibility to decide how to monitor whether a
drug is prescribed for a medically accepted indication, as well
as to determine whether the statutory defnition of "medically
accepted indication" is met with regard to the particular use of
a drug."
beneficiary may appeal
¾ The Preamble to 42 C.F.R. § 423 states:
? The Preamble to 42 C.F.R. § 423 states:
? If a Part D plan makes an adverse coverage decision, a
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Medicare Part D (cont.)
ƒ “Plans have the flexibility to decide how to monitor whether a
drug is prescribed for a medically accepted indication, as well
as to determine whether the statutory definition of “medically
accepted indication” is met with regard to the particular use of
a drug.”
¾ If a Part D plan makes an adverse coverage decision, a
beneficiary may appeal
MINTzLEvIN
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MINTzLEvIN
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3729 et seq.), and the anti-kickback statute
The Part D plan sponsor agrees to comply with Federal laws and
regulations designed to prevent fraud, waste, and abuse, including, but
not limited to applicable provisions of Federal criminal law, the False
Claims Act (32 U.S.C. §§ 3729 et seq.), and the anti-kickback statute
(section 1128B(b) of the Act).
Medicare Part D (cont.)
The Part D plan sponsor agrees to comply with Federal laws and
regulations designed to prevent fraud, waste, and abuse, including, but
not limited to applicable provisions of Federal criminal law, the False
Claims Act (32 U.S.C. §
(section 1128B(b) of the Act).
¾ 42 C.F.R. § 423.505(h)(1):
? 42 C.F.R. § 423.505(h)(1):
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Medicare Part D (cont.)
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Abuse
¦ Section 70 provides examples of potential schemes, risks, and
vulnerabilities to the Part D beneft. Given that Sponsors
maintain ultimate responsibility for delivery of the beneft,
Sponsors are encouraged to develop their program to control
fraud, waste and abuse to address identifed risks.
? Chapter 9: Part D Program to Control Fraud, Waste and
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Medicare Part D (cont.)
Medicare Part D (cont.)
¾ Chapter 9: Part D Program to Control Fraud, Waste and
Abuse
ƒ Section 70 provides examples of potential schemes, risks, and
vulnerabilities to the Part D benefit. Given that Sponsors
maintain ultimate responsibility for delivery of the benefit,
Sponsors are encouraged to develop their program to control
fraud, waste and abuse to address identified risks.
MINTzLEvIN
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? Chapter 9: Part D Program to Control Fraud, Waste and
¦ Section 70.1.6: Examples of Pharmaceutical Manufacturer
o Kickbacks, inducements, and other illegal remuneration,
o Illegal off-label promotion: Illegal promotion of off-label drug
Fraud, Waste and Abuse:
Abuse
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Medicare Part D (cont.)
ƒ Section 70.1.6: Examples of Pharmaceutical Manufacturer
Fraud, Waste and Abuse:
Medicare Part D (cont.)
including inappropriate marketing and/or promotion of
products.
usage through marketing, fnancial incentives, or other
promotional campaigns.
¾ Chapter 9: Part D Program to Control Fraud, Waste and
Abuse
o Kickbacks, inducements, and other illegal remuneration,
including inappropriate marketing and/or promotion of
products.
o Illegal off-label promotion: Illegal promotion of off-label drug
usage through marketing, financial incentives, or other
promotional campaigns.
MINTzLEvIN
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? Prescription drugs prescribed for off-label indications may be covered
Part D drugs, provided the drug is prescribed for a "medically accepted
? Guidance on off-label promotion in Part D is sparse
? Government will rely on Part D plan sponsors to monitor for indications
of off-label promotion
? Medicare Drug Integrity Contractors (MEDICs) will also monitor for
indications of off-label promotion
¦ Indications of off-label promotion would initiate an immediate
referral to the Office of the Inspector General
in Part D or in other programs)
indication"
Look for additional guidance in the future as schemes are identifed (either
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Medicare Part D (cont.)
Medicare Part D (cont.)
MINTzLEvIN
MINI r. LE VIN COI IN l riuiis (ii .OVS
¾ Prescription drugs prescribed for off-label indications may be covered
Part D drugs, provided the drug is prescribed for a “medically accepted
indication”
¾ Guidance on off-label promotion in Part D is sparse
¾ Government will rely on Part D plan sponsors to monitor for indications
of off-label promotion
¾ Medicare Drug Integrity Contractors (MEDICs) will also monitor for
indications of off-label promotion
ƒ Indications of off-label promotion would initiate an immediate
referral to the Office of the Inspector General
Look for additional guidance in the future as schemes are identified (either
in Part D or in other programs)
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Mintz Levin Cohn Ferris Glovsky and Popeo, P.C.
Boston Office:
One Financial Center
Boston, MA 02111
617-542-2241
Phone: 617-348-1676
Fax:
Thomas S. Crane, Esq.
[email protected]
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Presented By:
Presented By:
Washington, D.C. Office:
701 Pennsylvania Ave. N.W.
202-434-7400
Washington, D.C. Office:
701 Pennsylvania Ave. N.W.
Washington, D.C. 20004
Phone: (202) 661-8787
Fax: 202-434-7400
Washington, D.C. 20004
Phone:
Fax:
Boston Office:
One Financial Center
Boston, MA 02111
Phone: 617-348-1676
Fax: 617-542-2241
Thomas S. Crane, Esq.
Mintz Levin Cohn Ferris Glovsky and Popeo, P.C.
(202) 661-8787
[email protected]
MINTZ LEUIN
Nil IN I % I,N.VIN COI I
Pc PK)
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