The Meeting Planner s Challenge: Contending with Ever-Changing Healthcare Regulations

Transcription

1 The Meeting Planner s Challenge: Contending with Ever-Changing Healthcare Regulations Rosaelena Bernaducci, CMP Sr. Meeting Professional & Compliance Manager Bernaducci & Assoc

2 Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter(s) and should not be attributed to any organization with which the presenter(s) is employed or affiliated. These PowerPoint slides are the intellectual property of Rosaelena Bernaducci, CMP and are protected under copyright laws of the United States of America and other countries. Used by permission only and all rights reserved.

3 Compliance in Any Language Course Objective: What is Compliance and Why does it Concern Me? Governing Rules, Regulations and Codes for Healthcare Compliance per Meeting Type Where Do I Start Meeting Planner s Top Ten List

4 Laws, Codes, Acts, Rules: Why Relevant in Meeting Management? Compliance Definition - Obeying law, rule, or request Perception ROI Accountability Transparency Legal and Financial Risk

5 Meeting Managers / Professionals: Purchase goods and services Represent the company Interact with internal and external stakeholders Financially accountable Legally accountable

6 HCP Definition Example Definition Only Healthcare Professional (HCP)- Members of the medical, dental, pharmacy and nursing professions, their staff and or anyone else who may in the course of their professional ac9vi9es prescribe, supply, administer, or buy any medicines; researchers and inves9gators; and any other individuals engaged in healthcare- related prac9ces or employed by a healthcare ins9tu9on Make certain you know your client s defini<on of an HCP

7 Timelines ACCME Guidelines: 1987 AMA Guidelines 1990 FDA Guidance: 1997 PhRMA Code: 2002 OIG Guidance: 2003 Congressional Investigations led to greater scrutiny Increase in findings and Corporate Integrity Agreements (CIAs) Revised AdvaMed and PhRMA Codes Healthcare Reform 1020 Sunshine Act - March 2010

8 Influential Organizational Structures Government U.S. Food and Drug Administration Health and Human Services Office of Inspector General / Department of Justice Professional AMA Accreditation ACCME

9 Additional External Influences Dept of Justice (DOJ) / Health & Human Services (HHS) / Centers for Medicare & Medicaid (CMS) Press / Consumer Advocates Individual States Institutions and Research Facilities Hospitals and Clinics

10 Office of Inspector General (OIG) Purpose: To help companies prevent healthcare fraud and abuse by promoting a high level of ethical and lawful corporate conduct. Recommend Compliance Programs 7 elements to build a successful compliance program Perform due diligence and investigations Deliver CIAs, penalties and monitor adherence Source:

11 Federal Laws: Anti-Kickback Statute Knowingly Offering/receiving or paying/soliciting Remuneration (including kickback, rebate, bribe) In cash or in kind exchange To induce someone to refer a patient or to purchase, lease, order or recommend these activities Any goods or services reimbursable under federal healthcare programs, i.e., Medicare/Medicaid *this can be a direct or indirect activity Source:

12 Examples of Remuneration = $ Besides the obvious.. Travel airfare / ground transport Accommodations Meals Honoraria / Fee for Services / Royalties Gifts: Some companies exclude gifts altogether. Make certain you know your client s policy! Benefits to patient Should not be of substantial value Must be related the Physician s practice

13 False Claims Act Prohibits a person from knowingly submitting or causing to be submitted claims, making false statements to secure payment by the government No specific intent required Speaks to off label promotion and Speaker Training Programs Can cover mfrs/consultants providing incorrect coding advice Source: FalseClaimsAct_SMD pdf

14 Disclosure/ Federal Sunshine Act now known as Open Payments PURPOSE: To provide transparency in the relationship between physicians and manufacturers of pharmaceuticals, medical devices, biologics, or medical supplies for which payment is made under a federal health care programs Starting January 1, 2012 manufacturers must record all transfer of value to HHS on an annual basis which starts on March 31, 2013 Health & Human Services (HHS) will report on a publicly available website available as of September 30, 2013 and every June 30 thereafter Federal law trumps state law, except MN Who? All physicians and teaching hospitals Payments related to research & producing devices may delayed up to 4 yrs or until product approved by FDA, whichever is first

15 Federal Sunshine Act/ Open Payment REQUIREMENT: Mfrs and distributors (drugs and devices) to report: Payments or items of value provided directly or indirectly to any covered health entity in connection with promotional activities Whether cash or of value for ex: food, entertainment, gifts, travel, consulting fees, honoraria, research/grants, educational/conferences, stocks/stock options, ownership/investment interest, royalties/licenses, charitable contributions & any other transfer of value 90 Days to Report Source:

16 Federal Sunshine Act: Penalties Each failure to report, fines up to $10,000 not to exceed $150,000 annually For each knowing failure to report fines of $100,000 not to exceed $1,000,000 annually

17 Changes in 2014 Many dates were changed at the last minute due to glitches in the collection of data, including some data will not be shown on the website CMS has made a change for HCP Speaker fees to be part of the collection of information including at CME events Ø This is being challenged by the PhRMA Association, AMA and most Medical & Pharmaceutical Associations, letters have been written to go back to the original statement where CME meetings/events data not captured this is something to continue to follow

18 Sarbanes-Oxley (SOX) Enacted in July 2002 as a reaction to many corporate scandals Enron, Tyco International, Adelphia, WorldCom, etc. Set a new standard for all US publicly-traded companies Now being extended to large private companies Contains 11 main sections, 6 of which apply to meeting management Source:

19 Sarbanes Oxley and Stark Regulations SOX Pertains to financial transactions, transparency in coding and accounting controls CEO or CFO must report any deficiencies in accounting controls and / or any fraud involving the management of funds Stark Source: Governs relationship between private physicians, group practices and hospitals regarding referrals outside of their practice..to ensure no financial gain or conflict of interest Source:

20 Code of Ethics / Standards PhRMA Code Pharmaceutical Research and Manufacturers of America Code of ethics agreed upon by pharmaceutical and biotechnology companies devoted to inventing medicines. AdvaMed Code An agreed upon code of ethics by Medical Devices, diagnostic products

21 PhRMA Codes First guidelines in 2002; Readapted in January 2009 Self regulated and voluntary Only GUIDELINES, not law Pharmaceutical companies volunteer to follow the guidelines Fundamental principle: An HCP s care of patients based solely on medical needs & professional knowledge Educational items: $100 or less and do not have value to HCP outside professional responsibilities Prescriber data: use patient data responsibly Source:

22 PhRMA Codes Interaction Focused on Informing HCPs on products, data & educational information Informational Presentations having modest meals & only of educational value Sales & Marketing Presentations are limited to doctors office or hospital only, modest meals & no take away food No Pharmaceutical company support for Continuing Medical Education (CME) No Pharmaceutical company support for Third-Party Educational or Professional Meetings Scholarships and Educational funds: For medical students, residents, fellows & other HCPs to attend conferences Source:

23 PhRMA Dictates: How You Choose Consultants: Based on expertise Arrangements not a reward Compensated on reasonable travel expenses Fees should be fair market value (FMV) Written / Executed Contract Legitimate Need Venue for meeting should be appropriate Engagement End Did the meeting / program happen as you had planned? Independence and decision making: No grants, scholarships, subsidies, etc Should not be offered to HCP for prescribing drugs

24 AdvaMed: Advanced Medical Technology Association First Codes 2003; Revised Codes in July 1, 2009 HCPs must act in the best interest of patients through beneficial collaborations with HCP Must meet high ethical standards: Must conduct business with transparency and in compliance with applicable laws, regulations & government guidance Source:

25 SOX Compliance for Meeting Management: DUE DILIGENCE Get 3 or more bids from ALL suppliers If you know the supplier, have back up as to WHY using them, not just a personal relationship which can be misconstrued Negotiate and Remember Perception Issue If out of guidelines get approval from highest level in writing Increase your cost savings, cost avoidance and your ROI

26 Responsibility We are all responsible Do you work on budgets? Sourcing of any suppliers? Work directly with the client? Do you just do the grunt work? Have Complete Documentation * Whether you have any part in any decision making or not, YOU are still accountable

27 Pulling your hair out yet trying to figure which is which?

28 Additional Laws: International Codes FCPA: Foreign Corrupt Practices Act Europe: EU Code of Practice for Promotion of Medicines UK: Association of the British Pharmaceutical Industry (ABPI) Eucomed: Code of Ethics for Medical Technology companies interacting with HCPs *Consult Office of Ethics and Compliance in each country of attendee s origin

29 Foreign Corrupt Practices Act (FCPA) 1977 Great focus on FCPA NOW! Anti-bribery provisions of the FCPA make it unlawful for a U.S. person or firm, to make a payment to a foreign official for the purpose of obtaining or retaining business for or with, or directing business to, any person. Government Official is BROAD know who you are interacting with Both Consultant(s) and Vendors / Suppliers Source:

30 So What is the Big Deal? Fines, fines, fines.. Up to $250,000 for individuals and $500,000 for companies Criminal prosecu<on of corpora<ons AND / OR individuals (up to 5 years imprisonment) Civil penal<es Exclusion from federal health care programs Civil monetary penal<es: $50,000 for each act plus 3 x amount of illegal remunera<on False Claims: Penal<es of up to $10,000, PLUS 3 x amount of damages sustained

31 Noteworthy Codes and Mandates we speak of today: Many are applicable per meeting type Life Sciences Industry interprets these codes differently Processes and Standards vary per company / clientele and organizations Although PhRMA Code and AdvaMed are not required by law and are technically voluntary.. BEST interest to follow these guidelines

32 Know Compliance Per Meeting Type Colleague / Internal VIP Meetings Sales Trainings Business Meetings Launch Plan of Action Meetings Meetings with HCPs: Study Related: IMs, HCP Consulting Meetings,Ad Board, Investigator, FDA Medical: Determine promotional or non promotional activity IMs, HCP Consulting, Meetings Commercial: Speaker Trainings, KOL / Consultant Meetings, CMEs

33 Future The Bad News and The Good News! Government is asking for more accountability More state laws Increase in Prosecutors up by more than 25% Seems to be getting stricter in the International community EU Sunshine Act effective January 1, 2015 Transparency, transparency, transparency More Institutional rules More enforcement actions and additional settlements Good News: Increased Value Proposition for Meeting Professionals and Suppliers Seize The Opportunity! * Next Biosimilars already in the works

34 Meeting Planners Top Ten List 10. Know Your Customer s Objective, Business and Language 9. Be the Subject Matter Expert on Adherence to Regulations and Codes 8. Partner with Legal and Compliance Officers / Experts 7. Know your client s definition of an HCP get it in writing 6. Communicate to your Client s and Organization you need to know: Their interpretation of the Codes What are their SOPs governing interactions with HCP

35 Top 10 List Continued 5. Be Where the Ball Is: Analyze the risk and do the work for them: - Compliant Contracts, Reasonable Menus, No suite upgrades for staff or HCPs - Reporting spend per HCP per state, documentation, audit documents 4. Document all important decisions 3. Create your own audit trail (BACK UP!!) for each file and review for accuracy with SOPs in place 2. Create Your Meeting Planner s Tool Box and Reference it often 1. Take a deep breath and cross your fingers!!!!

36 Resources: Industry Communications MPI, PCMA and Others Websites, LinkedIn and other Social Media Magazines and Press Releases Newsletters, briefings from Legal and / or Compliance Offices Rosie Contact information attached

37 Educational Resources CMP HC: great for accountability and knowing of the industry (must know CME, HCP & Academia pharma, medical devices, medical supply & Biologics) both domestic & international & have your CMP prior all information for the exam is on the CIC website there are over 13 pages of materials, some books, some websites Pat Schaumann, CMP, CSEP, DMCP: offers a course through a university with her book Breaking the Code to Healthcare Compliance, a must read!! PCMA: offers reading material & information for the CMP-HC MPI: is in development of new programmes working with Pat Schaumann Policymed.com: Thoams Sullivan s website up to date real info

38 Gifts Meals Hotels Honorariums Travel Entertainment PhRMA Code USA No, or $100 or less Modest Modest, no Resorts or 5 Star Fair Market Value Modest NO Sunshine Act NO Modest Modest Fair Market Value Modest & Justified NO AdvaMed No, or $100 or less Modest Modest Fair Market Value Modest NO IFPMA (Int l) NO Modest Modest Fair Market Value Modest & Justified NO EFPIA (Europe) Promo only Modest Modest Fair Market Value Modest & Justified NO FEDERFARMA (L. America) Promo only Modest Modest, up to 4 Star Fair Market Value Modest NO

39 Rosaelena Rosie Bernaducci, CMP Sr. Meeting Professional & Compliance Manager Both Domestic & International Bernaducci & Assoc. Point Pleasant, NJ Phone: +1 (732)

40 Thank you for attending Understanding Medical Meetings Learn about past and upcoming webinars at collaboratemeetings.com/webinars, connectyourmeetings.com/webinars or rejuvenatemeetings.com/webinars. Links to these sites as well as a certificate of attendance will be sent to you automatically for attending live. ndupuis@collinsonmedia.com for a certificate after watching the recording. Join us next week for a webinar on AV production.