3/6/2012 1 Greg Radinsky, JD, MBA, CHC, CCEP Vice President & Chief Corporate Compliance Officer North Shore-LIJ Health System 2012 HCCA Compliance Institute April 30, 2011 – Las Vegas, Nevada Don't Roll the Dice -- The Top 10 Conflicts of Interest Developments Impacting Physicians Goals of the Presentation Brief overview of new COI laws and industry guidance Discuss implementation pitfalls Provide practical COI tips and tools Answer your questions
Transcript
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Greg Radinsky, JD, MBA, CHC, CCEP Vice President & Chief Corporate Compliance OfficerNorth Shore-LIJ Health System2012 HCCA Compliance Institute April 30, 2011 – Las Vegas, Nevada
Don't Roll the Dice -- The Top 10 Conflicts of Interest Developments Impacting Physicians
Goals of the Presentation
Brief overview of new COI laws and industry guidance Discuss implementation pitfalls Provide practical COI tips and tools Answer your questions
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Background: Key Laws and Industry Guidance
Federal and State Anti-Kickback Statutes and Stark States and Federal Claims Acts CMPL Prescription Drug Marketing Act State Pharmaceutical Disclosure Laws Joint Commission Standards OIG Compliance Program Guidance PhRMA Code AdvaMed Code AAMC Task Force IRS – Form 990
Manufacturers to report any payments to physicians/teaching hospitals above $10 unless an exception applies
Broad definition of payment
Manufacturers plus GPOs must report any ownership/investment interests by a physician and his/her immediate family
Proposed rule (Comments due Feb. 17, 2012)
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National Interaction Statistics
Percent of physicians interacting with industry 29%
Average # of interactions per physician with at least one interaction
2.7
Average amount of total interactions per physician with at least one interaction
$6,400
Average amount per interaction $2,350
Number of physicians receiving over $10,000 14,390
Number of physicians receiving over $100,000 2,875
Source: Kyruus – Data includes payments from 2009, 2010, 2011
Industry InteractionsNational Statistics
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What Will be the Real Impact of the Physician Sunshine Provisions?
2012 Top 10 List: #9 Anti-Kickback Statute (PPACA Section 6402(f))
PPACA section 6402(f) eases the government’s requirements to bring an AKS action
PPACA changes:
“a person need not have actual knowledge of [the AKS] or specific intent to commit a violation of [the AKS]”
“a claim that includes items or services resulting from a violation of [AKS] constitutes a false or fraudulent claim for purposes of [the False Claims Act]”
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2012 Top 10 List: #8 Co-Marketing Arrangements
Co-Marketing Arrangements Vendor/healthcare provider product/service advertisements Vendor patient general education brochures Community patient education events Vendor training agreements
2012 Top 10 List: #7 - Other Common Physician Issues
Educational Grant Activities Speakers’ Bureaus Vendor FDA Related Training SEC Registration Disclosure Forms Royalty Agreements Establishing 501(c) (3) Foundations
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2012 Top 10 List: #6 Physician-Owned Distributorships (PODs) “These business ventures raise substantial concerns that a
physician’s [ROI] from the venture may influence the physician’s choice of device.” – OIG Feb. 2008
“Senators Request Probe of Surgeons” – WSJ June 9, 2011
PODs – Senate Finance Committee, June 2011
OIG national study on spine implant PODs expected in 2012
“In Small California Hospitals, The Marketing of Back Surgery –WSJ Feb. 9, 2012
Different legal views
2012 Top 10 List: #5 COI Public Disclosure to Patients
Joint Commission Standard LD.04.02.01
“…5. Policies, procedures, and information about the relationship between care,treatment, and services and financial incentives are available upon request to all patients, and those individuals who work in the hospital, including staff and licensed independent practitioners.”
June 2010 AAMC Report: In the Interest of Patients: Recommendations for Physician Financial Relationships and Clinical Decision Making
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Accuracy of Conflict-of-Interest Disclosures Reported by Physicians, N. Engl. J. Med. 2009; 361: 1466-1474, Oct. 8, 2009
Reasons for non-disclosure was that the payment was unrelated to topic of presentation and physician misunderstood the disclosure requirements
Disclosure Rate was 71.2%
79.3% for direct50% for indirect
IRS Form 990 – Transparency
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2012 Top 10 List: #4 – Research
HHS Final Rule Financial Conflict of Interest Rules for Researchers
More stringent Investigator disclosure requirements
SFI disclosure threshold lowered generally from $10K to $5K
Public disclosure requirements
Training requirements
2012 Top 10 List: #3 Continued Government Enforcement
Several Large Industry Qui Tam AKS Related Settlements Include treating physicians to lavish resorts, entertainment, disguising
educational grants, sham consulting arrangements, and inflated speaking fees Medtronic (Medical Device) $23.5 million
Allegedly paid physicians ~$1,000 to $2,000 per patient for a physician’s participation in post-market studies/device registries
2 South Florida Physicians (DME related) Gifts, Miami Dolphin tickets, meals ($65,000 and $57,000)
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2012 Top 10 List: #3 Continued Government Enforcement
Examining the Relationship Between the Medical Device Industry and Physicians, Testimony of Gregory E. Demske, Assistant Inspector General for Legal Affairs, Feb. 2008
OIG – A Roadmap for New Physicians, Avoiding Medicare and Medicaid Fraud and Abuse, Nov. 2010
U.S. Senate Committee on Finance, Staff Report on Cardiac Stent Usage at St. Joseph Medical Center, Dec. 2010
Government likely to focus on “fair market value” of payments
2012 Top 10 List: #2 Increased Focus on Technical Requirements of Stark Related to Gifts
Non-Monetary Compensation Exception $373 limit applies to calendar year Limited exception if hospital inadvertently exceeds annual limit Government assumes hospitals track non-monetary compensation Memorial Hospital (Ohio) voluntary disclosure http://www.cms.gov/PhysicianSelfReferral/DPS/list.asp#TopOfPage
Medical Staff Incidental Benefits Exception Less than $31 per occurrence Item or service is provided to all members of the medical staff in the same
specialty without regard to volume or value of referrals
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2012 Top 10 List: #1 Changes to Beneficiary Inducement CMP
2002 OIG Special Advisory Bulletin, Offering Gifts and Other Inducements to Beneficiaries
PPACA Section 6402 – Adds four new exceptions to allow “charitable and other innocuous” programs Access to Care Coupons, Rebates and Rewards Programs Financial Need Waiver of Co-pays for Covered Part D Generic Drugs
Engage Clinical Leadership
Educate on the Law and Internal Policy
Data is King! – Medical Journal Articles
COI Enforcement Settlements Recruit Champions from Unbelievers
http://www.amsascorecard.org/
Don’t Forget to Educate the Vendors!
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COI Policy Educational Tools
Employee Gift Brochure Vendor Gift Brochure Employee COI Brochure Frequently Asked Questions Document Cartoons Outside Activity Approval Form Sample Gift Return Letter
Conflicts of Interest Training Example
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Awareness: Vendor Relations
Industry Interactions Application Form
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COI Monitoring Mechanisms
Conflicts of interest questionnaires Certifications related to code of conduct and related policies and
procedures Scope of individuals who complete an annual disclosure Procurement monitoring controls Compliance helpline and survey benchmarking Audits DRA mailing Contractual representations
Monitoring Control: Annual Conflicts of Interest Disclosure Form
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Monitoring Control: Annual Conflicts of Attestation Statement
I certify that I have read and am in compliance with the Code of Ethical Conduct and the NSLIJ Health System policies entitled Conflicts of Interest and Recusal and Gifts and Interactions with Industry to the best of my knowledge. I further certify that the information contained in this Disclosure is accurate and complete to the best of my knowledge.
