CHC Study Q Healthcare Compliance Certification (3) COI Exclusions

Term Definition
Conflict of Interest Occurs when an individual's private interest interferes in any way or even appears to interfere with the interest of the corporation as a whole
Scientific Conflict of Interest Participation in review panels/groups that make decisions regarding the allocation of resources or the publication of papers. Scientific testimony as an expert witness
Clinical Care Conflict of Interest A set of circumstances that creates a risk that professional judgement or actions regarding a primary interest will be unduly influenced by a secondary interest
Conflict of Commitment A Situation when one's obligations to their employer or other entity are at odds with the commitments the individual has made in other areas
Physician Payments Sunshine Act Requirements Medical product manufacturers to disclose to the Centers for Medicare and Medicaid Services (CMS) any payments or other transfers of value made to physicians or teaching hospitals.
Physician Payments Sunshine Act A healthcare law to increase transparency of financial relationships between health care providers and pharmaceutical manufacturers.
Physician Payments Sunshine Act Report Requirements Describe the form of payments cash or equivalent, in-kind items or services, stock, stock options, or any other ownership interest, any other form pf payment or transfer of value
Physician Payments Sunshine Act Examples of Payments or Transfer of Value Consulting Fees, Honoraria, Gift, Entertainment, Food, Travel, Education, Research, Charitable, Royalty or license.
Physician Payments Sunshine Act Items NOT to Report Payments less than $10, less than $100 CY, product samples, patient education materials, loan of a device for less than 90 days, warranty replacement, discount rebates, in kind items for charity care, dividend or distributions for a publicly traded co.
Conflict of Interest IRS 501(c) 3 The policy is to protect this tax exempt co. interest when it is contemplating entering into a arrangement that might benefit the private interest of an officer or director of the co. or might result in a possible excess benefit transaction
A Conflict of Interest Policy Consist of a set of procedures to follow to avoid the possibility that those in positions of authority over an organization may receive an inappropriate benefit
A Conflict of Interest Policy Must Include Steps for determining whether a COI exits, procedures for addressing the COI, steps for violations of COI & recording/documenting steps followed for the reporting & outcome of COI.
PhRMA Code Revised and strengthened in July 2008, is part of an ongoing effort to ensure that biopharmaceutical marketing practices and informational activities comply with the highest ethical and professional standards.
PhRMA Code Basic Interactions Intended to benefit the patient
PhRMA Code Promotional Material Be accurate & not misleading, Make claims about product only when properly substantiated, reflect the balance between risks & benefits, be consistent with all other FDA requirements
PhRMA Code Informational Presentations Are allowed to take place during professional workday along with a occasional modest meal. Has to be tried to education if done by a Pharm Rep & it can only take place in Dr's office/Hosp setting. Cannot be a form of entertainment
PhRMA Code Entertainment & Recreation To not be provided to any professional who is not a salaried employee of the co. regardless of value, engaged as a speaker or consultant, secondary to an educational purpose.
PhRMA Code Continuing Medical Education Has to be a grant making function with a section criteria for making grant decisions to make sure education program is bona fide & financial support is not induced in any way
PhRMA Code Speaker Programs & Training Mtgs. Should be selected by specific criteria & not provide any kind of inducements by can be compensated by taking into account special criteria & venue must be appropriate & conducive to the information.
PhRMA Code Consultants Should be selected per educational/training criteria with payment & arrangement to be made per FMV.
PhRMA Code Token Arrangements Should not be provided.
FDA Guidance for Advisory Committee Members & Staff Guidance issued 8/2008 Re: objectivity of advisory committee & FDA Staff with a financial relationship being presented before FDA.
FDA Guidance Financial Disclosure by Clinical Investigators When financial interests in the sponsor, drug, device under study receive $25,000 outside sponsor support, equity/ownership interest in excess of $50,000, a proprietary interest of the investigator/drug/device.
FDA Guidance Disclosure Conflict FDA will evaluate the conflict & may take various actions including requiring further testing with non-conflict investigators before approving the drug/device.
OIG COI Special Advisory Bulletin Providers can offer beneficiaries inexpensive gifts, $10 each but cannot exceed $50 annually. Can offer more expensive items if it meets a statutory exception.
AdvaMed Code of Ethics 2004 Established Code of Ethics for Device & Manufactures
AdvaMed Code of Ethics Guidance Co. training & education, 3rd party training & education, sales & promotional mtgs., consulting arrangements, gifts -limit$100., reimbursement info. & education grants.
Office for Human Research Protection (OHRP) Guidance Under HHS linked to the protection of human subjects
Institute of Medicine (IOM) Report on COI in medical research, education & practice -recommends increased transparency in reporting COI & a ban on gifts.
National Science Foundation (NSF) Requires the investigator to disclose to a responsible representative of the institution a significant financial interest which is anything of monetary value.
National Science Foundation (NSF) Financial Interest An equity interest that when aggregated exceeds $10,000 per FMV & is more than 5% ownership interest in a single entity by investigator or family or salary/payments made to same parties exceed $10,000 during 12 months.
National Science Foundation (NSF) Proposal Prior to Co. is responsible for ensuring that the investigator reports all significant financial interest.
Public Health Services (PHS) Governs the National Institute of Health (NIH)
Public Health Services (PHS) Investigator Disclosure Requirements Any significant financial interest in entities whose financial interests might be affected by the research & require the institution to designate an institutional official to solicit & review the financial disclosure statements made by investigators
Public Health Services (PHS) Significant Financial Interest Income which when aggregated for the investigator or family exceeds $5,000 w/in 12 months. An equity interest in excess of $10,000 or 5% ownership in a single entity.
Company Requirement for COI A process is in place to identify & disclose COI, Include compliance obligations in all job descriptions, include compliance accountability within performance evaluations, corrective action is implemented as needed & exit interviews are completed.
Step 3 FSG for Compliance Program Screening & Evaluation of Individuals Co. shall use reasonable efforts not to include w/in the substantial authority Staff of the Co. anyone who Co. knew or should have know through the exercise of due diligence has engaged in illegal acts inconsistent w/ CP
Exclusions When imposed, no payment is made to anyone/business for any item or service furnished ordered prescribed by excluded party under Medicare, Medicaid or a Federal Healthcare Program.
Exclusions Reinstatement No payments can be made until person/business is reinstated & reinstatement has to be requested & granted.
Exclusion Timeline Exclusions are usually assigned for five year periods but OIG has the right to assign a reduce period. If convicted of 3 related crimes exclusion is permanent. If convicted of 2 related crimes, 10 yr exclusion
Mandatory Exclusions Convicted of a criminal offense relating to delivery of service under Medicare/Federal Health Programs, Offense Re: neglect/abuse of patients healthcare services, Re: a felony: fraud,theft, embezzlement, breachfid duty/misconduct, manuf-RX controlled sub
Permissive exclusion Range from 1-3 years but may be adjusted per mitigating/aggravating factors
Corporate Integrity Agreement (CIA) Enforcement tool used by the OIG w/in HHS to improve the quality of health care and to promote compliance to health care regulations. Similarly, the term Integrity Agreement (IA) is used for smaller health care providers such as physicians.
Why enter into a Corporate Integrity Agreement (CIA) Entered into w a civil settlement of who has been the subject of invest under FCA who has been found guilty. Provider/entity consents to these obligations in exchange for OIG's agreement not 2 seek exclusion from participation Federal health care program

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