Mais conteúdo relacionado Semelhante a Preparing for Healthcare Professional Transparency (20) Mais de Huron Consulting Group (20) Preparing for Healthcare Professional Transparency2. Introduction
WEBINAR MODERATORS AND SPEAKERS
Moderated by Ben Comer, Senior Editor, Pharmaceutical Executive, the following leaders from
Huron Consulting Group and King & Spalding will serve as today’s webinar speakers:
Paul Silver
Managing Director
Huron Consulting Group
Manny Tzavlakis
Managing Director
Huron Consulting Group
Nikki Reeves
Partner
FDA & Life Sciences Practice
King & Spalding LLP
Seth Lundy
Partner
FDA & Life Sciences Practice
King & Spalding LLP
© 2013 Huron Consulting Group. All Rights Reserved. Confidential - Not for Distribution
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3. Introduction
WHY ARE WE HERE TODAY?
After this webinar, you will gain
additional insight into:
How various entities (e.g., regulators,
competitors, customers, etc.) could interpret
Open Payments data and the associated
risks to your company
The potential for personal liability with
regards to wrongful reporting
Ways to utilize this information to add
greater business value
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6. Introduction
DISCLOSURE, LITIGATION & THE FUTURE
$30.2
billion
Payments the pharmaceutical
and medical device industry has
paid for civil and criminal
penalties to the US and state
governments- the industry
continues to face more
allegations of wrongdoing on a
global scale (i.e., China).1
What will be the total
number disclosed to CMS
in 2014 by industry?
1.
2.
$?
billion
$2.1
billion
Approximate amount of HCP
payments publicly disclosed as
of 2013 by 15 pharmaceutical
and medical device
companies– under Corporate
Integrity Agreements or
voluntarily. 2
How will this
impact/influence future
litigation, media and public
opinion?
Source: Kelton, Erica. Is Big Pharma Addicted To Fraud. Forbes. July 2013.
Source: www.ProPublica.com. November 2013.
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7. Introduction
MEDIA PLAYS A ROLE IN TELLING THE STORY
How will the
media
interpret
open payments
disclosure data
to grab attention,
to tell a story…
Will your company have the facts and be
prepared to respond?
1.
Source: Clips sourced on www.youtube.com
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9. Publicly Available Data
THE AFTERMATH OF DISCLOSING DATA
All payments and transfers of value exceeding
$10 must be reported and tracked against the
individual HCP who received it by the
company. The report is due March 31, 2014.
HCPs will have access to the total reported
information prior to public posting.
HCPs will have the right to dispute and/or
question the expenditures with the company.
Once this information is publicly posted, it is
available to regulators, newspapers,
customers, patients, competitors, and the
general public .
Source: CMS App for Open Payments for Physicians,
CMS website
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10. Publicly Available Data
CURRENT PUBLIC DISCLOSURE
Awareness is driven by mainstream media as well as by alternative media, such as
ProPublica, which has published detailed information about physician compensation
from Life Sciences companies.
The table below in as example of the data available from ProPublica:
Name / Payee
City
Year
Category
Amount
Jane Physician
Worcester
2012
Research
$2,762
Jane Physician
Jamaica Plain
2012
Meals
$281
Joe Roberts
Holyoke
2011
Items, Gifts
$251
Joe Roberts
John Smith
Boston
2011
Consulting
$2,400
Worcester
2010
Speaking
$65,890
John Smith
Worcester
2011
Speaking
$17,400
John Smith
Worcester
2011
Travel
$5,073
ProPublica also provides profiles for each individual HCP detailing information such as:
total compensation by company, specialty, and prescribing patterns.
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12. Mitigating Risk
CHANGING MARKET LANDSCAPE
Publicly disclosing payment information
and the increased scrutiny from
industry-related entities are causing
changes in the market landscape.
Companies are being forced to
adapt by:
Assessing their internal and
external strategies
Strengthening processes and
controls
Increasing collaboration across
Compliance, Commercial and
Clinical Development to mitigate
risk and become more efficient
Product
Commercialization
Clinical
Development
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Compliance
Healthcare
Professional
Engagement
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13. Mitigating Risk
MEDIA / INQUIRY PREPARATION
The media, customers, patients, and others may review this data for:
• Spend outliers within company peer groups
• Relationships between companies and HCPs – particularly those under or
related to an investigation(s)
• Since primary specialty will be posted, engagements with healthcare
professionals that may be off-label in nature
• Research related information such as which researchers are working for
competitors
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14. Mitigating Risk
KEY RISK: LOSS OF KEY OPINION LEADERS
Loss of KOLs
Risk
• Changes in the business and
transparency landscape may
change the willingness of
HCPs to engage with
pharmaceutical and medical
device companies
Strategic
relationships
will be even
more critical in
the future.
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15. Mitigating Risk
KEY RISK: LOSS OF KEY OPINION LEADERS
Potential Outcome
• Because even small
transactions will typically be
posted under Open Payments,
HCPs may no longer accept
sales rep “lunch-n-learns”,
educational items, or even
samples (which must also be
disclosed separately from the
Open Payments report)
• Potentially more significantly,
HCPs may no longer wish to
serve as Key Opinion Leaders
(KOLs) for clinical trials, speaker
programs, consulting, or for
other engagements
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Strategic
relationships
will be even
more critical in
the future.
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16. Mitigating Risk
PLAN: PROACTIVELY MANAGE KEY OPINION LEADERS
Proactively prepare
responses for
relationships that are likely
to be highlighted in the
media or in other outlets.
Consider “Pre-Disclosing”
transactions to key KOLs
to ensure their awareness
of what will be posted prior
to actual public posting.
© 2013 Huron Consulting Group. All Rights Reserved. Confidential - Not for Distribution
Handle inquiries and
disputes promptly,
accurately, and
consistently per
established policies &
SOPs.
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17. Mitigating Risk
KEY RISK: INACCURATELY REPORTING PAYMENT DATA
:
Potential Risk
A disorganized,
insufficient or lack of data
gathering & data
reporting processes,
capabilities, and systems.
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18. Mitigating Risk
KEY RISK: INACCURATELY REPORTING PAYMENT DATA
:
Potential Outcome
May result in inaccurately
reported payment data,
which can damage
reputation and the
relationship between the
companies and HCPs.
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19. Mitigating Risk
DEVELOP RISK REMEDIATION FOR REPORTING
Specific Risks Associated with Data
•
Remediation Steps
Key Account Management (KAM)
systematic
for
Manual data entry into the systems RISK may is• a Targeted trainingFOR REPORTING
PLAN: DEVELOP of record REMEDIATION toprocessemployees
ensure that
managing incorrectly.
be carried out interactions and relationships with your mostcomplete and
understand the importance of valuable
accurate data capture.
customers.
•
File transmission errors may occur – these include
issues related to date ranges, missed files, or other
system issues.
•
Ensure that transactions from given systems or
date ranges are present in the collected aggregate
spend data (based on outlier observations).
•
Transaction data fields may be incorrectly mapped
to final report data.
•
Update reporting engine business rules or
configuration to ensure that expected reports are
produced.
•
When the federal government, institutions, or the
media display and analyze company reporting data,
aggregation, calculation, or other types of errors
may result.
•
Where aggregation or mathematical errors have
been identified, contact the federal government or
other source to ensure that displayed data is
corrected.
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21. Types of Potential Impact and Liability
Business and reputational risk
Corporate legal liabilities
Individual legal liabilities
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22. Calendar the Key Dates
Jan. 1, 2014 – end of CY 2013 reports; begin tracking
for CY 2014
March 31, 2014 – CY 2013 reports due
May – June 2014 – 60-day dispute resolution period
begins
September 30, 2014 – CMS publication date for CY
2013 data
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23. Effects of Increased Transparency
IOM
Industry Groups
Press
Industry/HCP
Relationships
Regulatory and
Enforcement
Agencies
Medical Institutions
State Legislatures
U.S. Congress
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Physician Groups
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24. Business and Reputational Risks
There is little doubt that transparency of these relationships will
further increase scrutiny of industry/health care professional
relationships
Publication, communication and misunderstanding of these
reports may affect:
– Customer purchasing
– Ability to successfully contract
– Patient perception
– Public perception
– Government agency perception
– Peer relationships
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25. Corporate Legal Liabilities
Penalties For Failure to Report
(42 C.F.R.§403.912)
Manufacturers are subject to civil money penalties for failing to timely,
accurately, or completely report the required information
Inadvertently failing to report data subjects an applicable manufacturer to a
civil monetary penalty between $1,000 and $10,000 for each payment or other
transfer of value not reported timely, accurately, or completely (for each annual
submission, the total penalties for inadvertent failures to report may not exceed
$150,000)
Knowingly failing to report data subjects an applicable manufacturer to a civil
monetary penalty between $10,000 and $100,000 for each payment or other
transfer of value not reported timely, accurately, or completely (for each annual
submission, the total penalties for knowing failures to report may not exceed
$1,000,000)
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26. Corporate Legal Liabilities
Anti-Kickback Statute – 42 U.S.C. §1320a-7a(b)
The Anti-Kickback Statute makes it a criminal offense to knowingly
and willfully to offer, pay, solicit, or receive any remuneration to
induce or reward referrals of items or services reimbursable by a
federal health care program.
Penalties:
• Felony charge, punishable by maximum of $25,000 fine and up to
five years imprisonment, or both for each offense.
• Automatic exclusion from federal health care programs.
• Administrative proceedings to impose
• Civil money penalties
• Exclude party from federal health care programs. See Section 1128(a)(7) and
Section 1128(b)(7) of Social Security Act.
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27. Corporate Legal Liabilities
False Claims Act (qui tam) 31 U.S.C. § 3729
• “Any person who:
– (2) knowingly makes, uses, or causes to be made or used, a false record or
statement to get a false or fraudulent claim paid or approved by the
Government;
– (3) conspires to defraud the Government by getting a false or fraudulent claim
paid or approved by the Government;. . . or
– (7) knowingly makes, uses, or causes to be made or used, a false record or
statement to conceal, avoid, or decrease an obligation to pay or transmit
money or property to the Government,
– allows whistleblowers to bring a suit on behalf of the government against
individual or company responsible for the alleged fraud.” 31 U.S.C. § 3729.
– “Knowing” or “knowingly” means:
“(1) has actual knowledge of the information;
(2) acts in deliberate ignorance of the truth or falsity of the information; or
(3) acts in reckless disregard of the truth or falsity of the information, and no proof of
specific intent to defraud is required.” 31 U.S.C. § 3729.
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28. Corporate Legal Liabilities
False Claims Act (qui tam) 31 U.S.C. § 3729 (continued)
Penalties:
– “Civil penalty of not less than $5,000 and not more than $10,000,
plus three times the amount of damages which the Government
sustains because of the act of that person.” 31 U.S.C. § 3729
(emphasis added).
No actual knowledge required
– Person who acts in reckless disregard or in deliberate ignorance
of truth or falsity of information can be found liable under the Act.
31. U.S.C. § 3729(b).
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29. Corporate Legal Liabilities
Federal Food Drug & Cosmetic Act (FDCA)
Section 303(a) of FDCA imposes criminal sanctions against any person who
committed a prohibited act or caused such acts to be committed. 21 U.S.C. § 333.
– Fines and prison sentences determined by Federal Sentencing Guidelines.
Criminal Charges: Section 303 discusses the penalties for a violation of Section
301.
– A violation of 21 USC § 331, a second violation, or the intent to defraud or
mislead results in the following consequences.
• “(1) Any person who violates a provision of section 301 shall be imprisoned
for not more than one year or fined not more than $1,000, or both.
• (2) Notwithstanding the provisions of paragraph (1) of this section, if any
person commits such a violation after a conviction of him under this section
has become final, or commits such a violation with the intent to defraud or
mislead, such person shall be imprisoned for not more than three years or
fined not more than $10,000 or both.” 21 U.S.C. § 333.
– Felony if action done with intent to defraud or mislead, or a second offense
without intent
– Misdemeanor if no showing of intent
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30. Corporate Legal Liabilities
State Transparency/Aggregate Spend Disclosure Laws and
Compliance Program Laws
California Compliance Program Law, (Cal. Health & Safety Code §§ 119400119402)
Connecticut Compliance Program Law, (CT S.B. 428)
Nevada Marketing Code of Conduct and Compliance Program Law (Nev. Rev. Stat.
§ 639.570)
Massachusetts Code of Conduct and Practitioner Payment Reporting (MA SB 2863)
Washington, DC Marketing Disclosure Laws - D.C. Code §§ 48-833.01-.09
Minnesota Gift Prohibition and Payments to Practitioners Reporting Laws (Minn. Stat.
§§ 151.461; 151.47)
Vermont Prescribed Products Law
West Virginia Marketing Costs Disclosure Law (W.Va. Code § 16-29H-1)
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31. Individual Legal Liabilities
PARK DOCTRINE
What is the Park Doctrine?
• Permits misdemeanor convictions against company executives for
violations of the FDCA, even if the executive had no knowledge or
involvement in the offense, so long as the person is a “responsible
corporate officer.”
– Personal knowledge is not required, but only a factor that “may be relevant” in
deciding whether to bring criminal charges.
• Strict liability crime - can be convicted of federal crime based solely
on position in company.
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32. History of the Park Doctrine
United States v. Park, 421 U.S. 658 (1975)
– Defendant Park was the president of a large national food store and was convicted of
causing adulterated food to enter interstate commerce. Id. at 658.
– The Court of Appeals reversed, reasoning based on Dotterweich, that an individual had
to have some knowledge of wrongdoing. Id. The Supreme Court overruled this, and held
that knowledge of wrongdoing was not a requirement. Id.
– “The Act imposes upon persons exercising authority and supervisory responsibility
reposed in them by a business organization not only a positive duty to seek out and
remedy violations but also, and primarily, a duty to implement measures that will insure
that violations will not occur.” Id. at 658-59.
– “The defendant had, by reason of his position in the corporation, responsibility and
authority either to prevent in the first instance, or promptly to correct, the violation
complained of, and that he failed to do so. The failure thus to fulfill the duty imposed by
the interaction of the corporate agent's authority and the statute furnishes a sufficient
causal link.” Id. at 674.
– Supreme Court held that individuals who have the authority to prevent violations can be
held vicariously liable for the illegal acts of subordinates. Id.
• Responsible corporate officers have an affirmative duty to seek out and remedy
violations, and implement measures to prevent those violations. Id.
• Delegation to subordinates does not negate liability. Id.
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33. Park Doctrine: Who is a “Responsible
Corporate Officer”?
Anyone with authority to prevent or correct violations
Decisions regarding who is the “responsible corporate
officer” are left to “the good sense of prosecutors, the wise
guidance of trial judges, and the ultimate judgment of
juries.” United States v. Dotterweich, 320 U.S. 277, 285.
Typically:
– Highest ranking corporate officer (CEO)
– Executive with direct authority to implement corrective actions (i.e.
compliance officer)
– Examples - CEO, President, Chief Compliance Officer, Vice
President
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34. Beyond the Park Doctrine
Park doctrine has been taken to apply beyond
FDCA
– Anti-kickback Statute
– False Claims Act
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35. Disclosure Under CIAs
Most CIAs implemented since 2008 have required disclosure of
payments to HCPs and HCIs
“[T]he requirement of public disclosure of these
payments will help the Government, as well as
the health care industry and the public, to
monitor relationships and should have a sentinel
effect to deter kickbacks and other inappropriate
payment relationships.”
Gregory E. Demske, Chief Counsel
Office of Inspector General of the Department of Health and Human Services Testimony to
the U.S. Senate Special Committee on Aging Roundtable (Sept. 12, 2012)
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36. Recent Trends in CIA: Accountability
Certain senior management identified as “Certifying Employees” are
required to monitor their areas of authority and annually certify compliance
with federal health care program requirements, FDA requirements, and the
CIA.
–
“I have been trained on and understand the compliance requirements and responsibilities as they relate to
[department or functional area], an area under my supervision. My job responsibilities include ensuring
compliance with regard to the [insert name of the department or functional area.] To the best of my
knowledge, except as otherwise described herein, the [insert name of department or functional
area] of [company] is in compliance with all applicable health care program and FCA requirements,
and the obligations of the CIA.”
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37. Attestations: (42 C.F.R. § 403.908(h))
Each report, including any subsequent corrections to a filed report,
must include a certification by the CEO, CFO, Chief Compliance
Officer, or other Officer of the applicable manufacturer that the
information submitted is true, correct, and complete to the best of
his or her knowledge and belief.
If filing a consolidated report, the attestation applies to all
applicable manufacturers covered by the consolidate report.
If an applicable manufacturer submits updated data to resolve
disputes, the applicable manufacturer must re-attest to the
timeliness, accuracy, and completeness of the data, as required
during the original data submission. (78 Fed. Reg. 9502)
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38. Protect Against Potential Liabilities
Budget appropriately (dollars and personnel)
– Quick changes and responses may be required
Benchmark carefully
Consider some or all of the following proactive steps:
– Internal audits of payment data for accuracy and overall compliance (e.g., kickbacks,
industry codes and state gift bans)
– Policy/procedure reviews to ensure that reported payments are consistent with the
company’s internal requirements
– Tax reviews/opinions
– PR and crisis management planning for possible media reports
– Continue training efforts
– Coordinate with industry on uniform messaging
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39. Turning Risk & Liability into
Corporate Value:
Benefits of Disclosing Data
40. Turning Risk & Liability into Corporate Value
BENEFITS OF OPEN PAYMENT REGULATIONS
After the disclosure data has been analyzed and the trends
have been identified, a company can react to operational
changes by:
Altering sales and other go-to market strategies
Developing robust data gathering & reporting
processes and systems
Providing insight into competitor’s and industry’s actions
& strategies
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41. Turning Risk & Liability into Corporate Value
ANALYZE SPEND FOR BETTER BUSINESS INSIGHTS
Spend Analysis
Example of how to view and
show company spend on
individual HCPs by specialty area
and allows the ability to break
down the data by specialty area,
payment nature, and time frame.
Results may include analysis that
shows company spend on HCPs
by specialty area in order to help
identify which specialty area(s)
and HCPs are receiving the most
payments.
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42. Turning Risk & Liability into Corporate Value
BETTER UNDERSTANDING OF KEY OPINION LEADERS
With detailed disclosure data available in the near future, compliance-based influence
networks can be created to help understand therapeutic markets and how to market more
effectively in a compliant manner.
For illustrative purposes only.
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43. Turning Risk & Liability into Corporate Value
HELP MAKE BETTER ORGANIZATIONAL DECISIONS
Companies that adopt a comprehensive enterprise approach to
influence mapping can
drive competitive advantage in their respective markets.
Disciplined
influence intelligence
better informs
organizational decision making,
leading to improved outcomes
in product development and
commercialization.
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44. Questions To Consider
How concerned is your organization that Open Payments disclosure will impact your
relationships with KOLs?
What is your most significant concern about Open Payments disclosure in 2014?
What topics related to disclosure, transparency and data would you like to know more
about for future webinars?
To access the ProPublica data, please visit:
http://projects.propublica.org/docdollars/
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45. Thank You
Please contact our speakers for information presented during today’s session.
Paul Silver
Managing Director
Huron Consulting Group
678-672-6160
psilver@huronconsultinggroup.com
Manny Tzavlakis
Managing Director
Huron Consulting Group
646-520-0247
mtzavlakis@huronconsultinggroup.com
Nikki Reeves
Partner
FDA & Life Sciences Practice
King & Spalding LLP
202-661-7850
nreeves@kslaw.com
Seth Lundy
Partner
FDA & Life Sciences Practice
King & Spalding LLP
202-626-2924
slundy@kslaw.com
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Notas do Editor Beth:- Check any reference to pharma should say “pharmaceutical and medical device” - Change the word “manufacturer” to “company” throughout Beth:Add photos Add citation from Forbes article Embed video here? Matt-Show an example showing of research spend Make names anonymous Who is leveraged for researchVendor management Clinical Research payment related KOLs Add graphic with funnel of people going from large to small Add graphic with funnel of people going from large to small How to transition into this slide – show reports at high level Add presenter names and email addressesAdd Q&A - 4Polling questions – 2Post event questions - 3 Beth:Add photos