Disclosure of Financial Interest Policy 2772 Rev 0117

Disclosure of Financial Interest Policy #2772 Rev. 01/17

Disclosure of Financial Interest Policy • Medical Staff Policy Approved by the MEC’s • Aimed at protecting the integrity of Lee Health Medical Staffs • Requires disclosure of certain financial interests at the time of appointment, reappointment and throughout appointment cycle • Promotes transparency, does not prohibit legally compliant payments or ownership interests • Prompted by the Physician Payment Sunshine Act and/or Florida law related to Public Agency laws 1

Open Payment Program (*previously titled Physician Payment Sunshine Act) • Part of the Patient Protection and Affordable Care Act • Final Rule released by the Centers for Medicare & Medicaid Services in February 2013 • Purpose is to prevent fraud, abuse and waste in the health care system • Aims to increase transparency of financial relationships between the drug and device industries, healthcare providers, and patients • *Now referred to as Open Payment Program 2

Open Payments Program • Requires drug, device, biological and medical supply manufacturers and distributors to report, in significant detail, payments made to physicians and other medical institutions to the Federal Government on an annual basis • Affected manufacturers and distributors (including group purchasing organizations (GPOs)) must also report certain ownership or investment interests held by physicians and their immediate family members 3

Open Payments Program • List of reportable payments is very broad ØIncludes consulting fees, honoraria, food, beverage, entertainment, travel, and education • Data collection started August 2013 • Must be reported to CMS by March 31 annually • Data collected each calendar year is published each June of the following calendar year 4

Disclosure of Financial Interest Policy M 14. 01. 078 5

Disclosure of Financial Interest Policy (M 14. 01. 078) • Applies to Medical Staff Members (a physician, dentist, podiatrist, or psychologist with membership on one or more Medical Staff of Lee Health and all Advance Practice Providers credentialed by any Lee Health Medical Staff) • Completed Disclosure of Financial Interest Questionnaire sent to Medical Staff Services • Failure to disclose/non-compliance ØInitially handled by Medical Staff Services Ø 15 days to comply (optional additional 15 by MS President) ØReferred to MEC 6

Disclosure of Financial Interest Policy (M 14. 01. 078) • Financial Interests are defined as Payment(s) or Transfer(s) of Value from a Drug, Device, Biological or Medical Supply Vendor, Manufacturer or Supplier to the Medical Staff Member that are: Ø$500. 00 per payment/transfer or $1500/total for reporting period. Which is defined as (1) the twelve month period prior to the initial disclosure or (2) the time period between disclosures (i. e. reappointment period) • Or an Ownership or Investment interest held by the Medical Staff Member or Immediate Family Member in such a Vendor, Manufacturer or Supplier • Limited exceptions to disclosure for post-purchase training programs approved on a case-by-case basis by the Medical Staff Office and Compliance Department 7

Disclosure of Financial Interest Policy (M 14. 01. 078) • Medical Staff Members that have a Financial Interest may provide input into Purchasing Decisions, but may not make Purchasing Decisions that may be influenced by their Financial Interest(s) • A Purchasing Decision is the decision as to which Vendors, Manufacturers, or Suppliers are chosen for the purchase, lease, use, or acquisition of Drugs, Devices, Biologicals, or Medical Supplies for Lee Health, made in accordance with Lee Health policies and procedures 8

Disclosure of Financial Interest Policy (M 14. 01. 078) The Questionnaire includes the following mitigation plan options to address potential conflicts: Ødivestiture of ownership/investment interests; Ødeclination of future payments or transfers for value; or Ødeclination of future purchasing decisions connected to ownership/investment interests or payments or transfers of value. 9

Definitions and References Immediate Family Member - spouse; natural or adoptive child, parent or sibling; stepparent, stepchild, stepbrother, or stepsister; father, mother, daughter, son, brother or sister-in-law; grandparent or grandchild; the spouse of your grandparent or grandchild. Payments or Transfers of Value - includes but is not limited to consulting fees, compensation for services other than consulting, honoraria, gifts, entertainment, food and beverage, travel and lodging, education, direct or indirect research, charitable contribution, royalty or license, current or prospective ownership interests, direct compensation for serving as a faculty or as a speaker for a medical education program, grant, or any other payment or transfer of value that is greater than five hundred dollars ($500. 00) per payment or transfer of value, or great than fifteen hundred ($1, 500. 00) in total during the Reporting Period. Ownership Or Investment Interests - includes stock, stock options, partnership shares, limited liability company memberships, loans, bonds or other financial instruments that are secured with an entity’s property or revenue or a portion of that property or revenue but does not include an ownership or investment interest in a publicly traded security or mutual fund, an interest that arises from a retirement plan offered by the manufacturer or group purchasing organization through employment with that manufacturer or group purchasing organization, stock options and convertible securities received as compensation until the stock options are exercised or the convertible securities are converted to equity, or an unsecured loan subordinated to a credit facility. 10

Definitions and References Medical Staff Member - a physician, dentist, podiatrist, or psychologist with membership on one or more Medical Staff of Lee Health and all Advance Practice Providers credentialed by any Lee Health Medical Staff. Vendors, Manufacturers, or Suppliers includes: • Distributorships: An entity that is engaged in the distribution of a drug, device, biological or medical supply for sale or distribution in the United States or a Territory, Possession or Commonwealth of the United States and which holds title to the drug, device, biological or medical supply that it distributes. • Group Purchasing Organizations: An entity that operates in the United States or a Territory, Possession or Commonwealth of the United State and purchases, arranges for or negotiates the purchase of a covered drug, device, biological or medical supply for a group of individuals or entities, and not solely for use by the entity itself. • Manufacturers: An entity that is either (1) engaged in the production, preparation, propagation, compounding, or conversion of a covered drug, device biological, or medical supply for sale of distribution in the United States or a Territory, Possession or Commonwealth of the United States; or (2) under common ownership with an entity described in (1) of this definition, which provides assistance or support to such entity with respect to the production, sale or distribution of a covered drug, device, biological, or medical supply for sale and distribution in the United States, or a Territory, Possession or Commonwealth of the United States. 11

Definitions and References Drugs, Device, Biological, or Medical Supplies - any drug, device, biological or medical supply for which payment is available through a federally funded program (Medicare, Medicaid or the Children’s Health Insurance Program) separately or as part of a composite rate. With respect to a drug or a biological, this definition is limited to those drugs and biological products that by law require a prescription to be dispensed. With respect to a device or medical supply, this definition is limited to those devices that, by law, require pre-market approval by or premarket notification to the Food and Drug Administration. Reporting Period - For the Medical Staff Members’ initial financial disclosure, the twelve months immediately preceding the disclosure date. For any subsequent Medical Staff Members’ financial disclosures, the time period between the Medical Staff Members’ previous disclosure and the date of the subsequent disclosure. Purchasing Decision - the decision as to which Vendors, Manufacturers, or Suppliers are chosen for the purchase, lease, use, or acquisition of Drugs, Devices, Biologicals, or Medical Supplies for Lee Health, made in accordance with Lee Health policies and procedures (Medical Staff Members may provide input into Purchasing Decisions, but may not make Purchasing Decisions that may be influenced by their private economic interests). 12

Definitions and References CMS; Open Payment Program; https: //www. cms. gov/Open. Payments Lee Health Policy and Procedures: M 14. 01. 078 S 23. 00. 139 Lee Health; Medical Staff Bylaws, section 2. 10, Conflict of Interest 13

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