Enovis Corporation · NYSE:ENOV
Enovis — Investor Presentation (June 2013)
46 slides from Enovis's investor presentation, June 2013
Slide 1: OPEN PAYMENTS Program
OPEN PAYMENTS Program An Explanation of Section 6002 of the Affordable Care Act Center for Program Integrity June 2013 CMS Disclaimer: This information is a summary of the final rule implementing the National Physicians Payment Transparency Program (Medicare, Medicaid, Children's Health Insurance Pr
Slide 2: Background/Purpose
BACKGROUND/PURPOSE 2
Slide 3: OPEN PAYMENTS Defined
OPEN PAYMENTS Defined • Section 6002 of the Affordable Care Act, or the “Sunshine Act”, finalized in February 2013 • Creates a national transparency program for payments made to physicians or teaching hospitals from manufacturers and group purchasing organizations • CMS will collect and post the inf
Slide 4: Current Physician and Industry Relationships
Current Physician and Industry Relationships Collaborations between physicians and the medical manufacturing industry are common 94% of physicians have some type of relationship with industry1 Some examples of current financial ties between medicine and 83% of physicians report receiving food and be
Slide 5: Downstream Impacts
Downstream Impacts Physicians reporting industry relationships have important interactions which further increase the impact of these relationships: • 60% were involved in medical education • 40% were involved in creating clinical practice guidelines CMS Disclaimer: This information is a summary of
Slide 6: Impact of Industry-Physician Interactions
Impact of Industry-Physician Interactions • Cooperation promotes discovery and development of new technologies that improve health • Conflicts of interest can potentially arise because of financial ties between medicine and industry • CMS must remain neutral when presenting financial ties Innovation
Slide 7: Transparency Today
Transparency Today • Several states have existing transparency programs and publish similar information on public websites • Several dozen pharmaceutical companies have active Corporate Integrity Agreements (CIAs) – Some require publishing payments to physicians publically on their websites • Some o
Slide 8: Policy Overview
POLICY OVERVIEW 8
Slide 9: Overall Objectives of the Rule
Overall Objectives of the Rule • Annual reporting of payments or other transfers of value from applicable manufacturers to physicians and teaching hospitals • Reporting of physician and immediate family ownership and investment interests in applicable group purchasing organizations (GPOs) and applic
Slide 10: How It Works
How It Works Industry payments and other Companies collect information transfers of value are made to about payments and other physicians and teaching hospitals transfers of value and submit to CMS 10
Slide 11: Who Will Report
Who Will Report Applicable Manufacturers Entities that operate in the US and that either produce or prepare at least covered one drug, device, biological, or medical supply covered by Medicare/Medicaid/CHIP or operate under common ownership with applicable manufacturers • Certain entities under comm
Slide 12: Who Will Report
Who Will Report Applicable Group Purchasing Organizations Entities that operate in the US and that purchase, arrange for, or negotiate the purchase of covered drugs, devices, biologicals, or medical supplies • Includes physician owned distributors that purchase products for resale • Investment inter
Slide 13: What are Covered Products
What are Covered Products Drugs and biologicals: Devices and medical supplies: • For which payment is available • For which payment is available under under Medicare, Medicaid or the Medicare, Medicaid or the Children’s Children’s Health Insurance Health Insurance (CHIP) program, (CHIP) program, eit
Slide 14: Examples of Transfers of Value (TOVs)
Examples of Transfers of Value (TOVs) • Consulting fees • Charitable Contributions • Compensation for services other • Royalty or license than consulting, including serving • Current or prospective ownership or as faculty or speaker at an event investment interest other than CE program • Compensatio
Slide 15: TOVs That are NOT Reported
TOVs That are NOT Reported • Transfer of value less than • Discounts (including $10 unless the total rebates) aggregates to over $100 • In-kind items used for charity • Product samples care • Educational materials • Dividend or other profit directly benefits patients distribution • Loan of covered d
Slide 16: Who is Reported About
Who is Reported About Covered Recipients: Physicians • Doctor of Medicine • Doctor of Osteopathy • Doctor of Dentistry • Doctor of Dental Surgery • Doctor of Podiatry • Doctor of Optometry • Doctor of Chiropractic Medicine • Physicians do not need to be enrolled in Medicare, Medicaid, or CHIP or bil
Slide 17: Who is Reported About
Who is Reported About Covered Recipients: Teaching Hospitals • Teaching hospital is defined as any institution that received payment(s) under a Medicare: – Direct graduate medical education (GME) – Inpatient hospital prospective payment system (IPPS) indirect medical education (IME), or – Psychiatri
Slide 18: Reporting Examples
Reporting Examples Reporting of any TOV from applicable manufacturers to covered recipients. Dr. Smith attends lunch hosted by an applicable manufacturer with her clinical Example team to discuss a new drug. She’s impressed by it, and spends 12 months traveling and speaking to promote it, with expen
Slide 19: Reporting Examples
Reporting Examples Reporting of any TOV from applicable manufacturers to covered recipients. ABC University Teaching Hospital Example receives $10,000 from a drug manufacturer as a research grant. Note: Items underlined are reportable payments or transfer of values 19
Slide 20: Reporting Examples
Reporting Examples Reporting of physician or family ownership and investment interests in applicable GPOs and applicable manufacturers. Example Dr. Smith’s sister has an ownership interest in a major medical device manufacturer. Reporting of any TOV from applicable GPOs to physicians with ownership
Slide 21: Physician-Specific Issues
PHYSICIAN-SPECIFIC ISSUES 21
Slide 22: Continuing Medical Education (CME)
Continuing Medical Education (CME) An educational event itself (tuition/educational materials) is considered exempted from reporting for the speaker and attendees if all three of these conditions are met: (1) The program meets the accreditation or certification requirements and standards of the ACCM
Slide 23: Other TOVs Related to CME
Other TOVs Related to CME For CME which meet the three requirements: • For speakers: all transfers of value for exempted CMEs are not reportable • For attendees: tuition and educational materials are not reported, but other TOVs are reportable (e.g., travel support) For other educational events whic
Slide 24: Indirect Payments
Indirect Payments • An indirect payment goes from a manufacturer to a physician or teaching hospital through an intermediary – for example a specialty society or research organization • A payment is considered indirect, and reportable, if an applicable manufacturer or GPO requires, instructs, direct
Slide 25: Indirect Payments: Payments Directed by Manufacturers Through Intermediaries
Indirect Payments: Payments Directed by Manufacturers to Covered Recipients Through Intermediaries What is publically reported by CMS? Applicable Manufacturer or Applicable GPO Payment or Transfer of Value Intermediary Payment or Transfer of Value Covered Covered Recipient Recipient’s information CM
Slide 26: Third Party Payments: Payments Directed by Physicians
Third Party Payments: Payments Directed by Physicians to Other Individuals or Entities What is publically reported by CMS? Covered Covered Recipient Recipient’s information Applicable Manufacturer or Applicable GPO Payment or Transfer of Value Entity or Third Party (An Individual or Entity) “Individ
Slide 27: Treating Research Payments Differently
Treating Research Payments Differently • Providing a balance between transparency and innovation is very important for this program • Applicable manufactures and applicable GPOs will report the total amount of the research payment included in a research protocol or agreement provided to a teaching h
Slide 28: Delay in Publication and Displaying Research Differently
Delay in Publication and Displaying Research Differently • If they meet certain criteria, manufacturers can indicate that they wish to delay the publication of payments or other TOV related to research for up to four years or until the drug, device or biological under investigation achieves FDA appr
Slide 29: Operations
OPERATIONS 29
Slide 30: Program Functions
Program Functions Submitters 2 Submission & 5 Publication AM’s & GPO’s Attestation 1 4 Dispute Registration Resolution Reviewers Physicians & Teaching 6 Audit Hospitals 3 Review & Dispute CMS Disclaimer: This information is a summary of the final rule implementing the National Physicians Payment Tra
Slide 31: 2013 Program Cycle
2013 Program Cycle • Collection Period (8/1/2013 – 12/31/2013) • Registration Period (early 2014) • Data Submission Period (by March 31, 2014) • Data Review and Dispute Period (2nd Quarter in 2014) • Correction Period (2nd Quarter in 2014) • Publication (September 30, 2014) CMS Disclaimer: This info
Slide 32: 2014 and Beyond Program Cycle
2014 and Beyond Program Cycle • Collection Period (1/1/2014 – 12/31/2014) • Registration Period (early 2015) • Data Submission Period (by March 31, 2015) • Data Review and Dispute Period (2nd Quarter in 2015) • Correction Period (2nd Quarter in 2015) • Publication (June 30, 2015) CMS Disclaimer: Thi
Slide 33: Data Collection Requirements
Data Collection Requirements General Physician Ownership Research A link to the data collection specifications for the 2013 OPEN PAYMENTS program cycle is NOW posted on http://go.cms.gov/openpayments CMS Disclaimer: This information is a summary of the final rule implementing the National Physicians
Slide 34: Data Templates Identify the Key Data Points for Reporting
Data Templates Identify the Key Data Points for Reporting • Identity of the applicable manufacturer or applicable GPO • Identifiers for the covered recipient – Physicians: name, business address, specialty, NPI, state license information – Teaching Hospital: name, address, TIN (all provided in the t
Slide 35: The Operations: TODAY
The Operations: TODAY CMS is actively: • Finalizing the data collection specifications that applicable manufacturers and applicable GPOs can use • Developing tools that can be used by physicians to track transfers of values • Launching educational modules explaining the rule • Developing a technolog
Slide 36: Physician Role & Resources
PHYSICIAN ROLE & RESOURCES 36
Slide 37: 2013 OPEN PAYMENTS Cycle Voluntary Physician Actions
2013 OPEN PAYMENTS Cycle Voluntary Physician Actions Industry will: Industry will: Industry will: CMS Public Collect information on Register and submit Correct disputed Website: payments and other 2013 information to information 2013 Information transfers of value CMS Posted August – December 2013 J
Slide 38: Tracking Your Payments
Tracking Your Payments • It is important that physicians and teaching hospitals track their own payments and other transfers of value throughout the year • This will provide accurate information to compare against what the industry reports about you to CMS • CMS is developing tracking tools that you
Slide 39: Registering with CMS
Registering with CMS • Registration is voluntary for physicians and teaching hospitals • Physicians and teaching hospitals should register with CMS so that they will be able to dispute inaccurate information • A primary and backup can register with CMS (note: for physician registrants, the physician
Slide 40: Reviewing Your Information
Reviewing Your Information • Registered users will be able to review the information submitted by industry about them prior to public posting (45 day period) • Physicians and teaching hospitals should review their information and dispute any inaccuracies – The primary or backup user can review and d
Slide 41: Correcting Information
Correcting Information • Corrections to disputed information must be made by the manufacturer or GPO – Physicians should work with industry to ensure corrections are made properly • Any disputes issued during the 45-day period should be resolved by the applicable manufacturer or applicable GPO, • Co
Slide 42: Resources for Physicians
Resources for Physicians AVAILABLE NOW COMING SOON Webpage dedicated to • Mobile Application to track Physicians transfers of value Fact Sheet specific to Physicians • File for tracking payments CME Modules (through • List of questions to ask Medscape) Industry prior to interaction NEJM arti
Slide 43: Support Resources
Support Resources CMS Program Website: Fact Sheets, Frequently Asked Questions, Links http://go.cms.gov/openpayments CMS Disclaimer: This information is a summary of the final rule implementing the National Physicians Payment Transparency Program (Medicare, Medicaid, Children's Health Insurance Prog
Slide 44: Physician Tracking Mobile Application
Physician Tracking Mobile Application • CMS is developing a mobile application that physicians can use to track their own transfers of value • Anticipated release in July 2013, in time for data tracking • Will help you have your own list of information to compare what the industry submits about you
Slide 45: Apps Exchange Info: Easier, More Accurate Data Collection
Apps Exchange Info: Easier, More Accurate Data Collection Physician App Industry App Send Profile Information Send Profile Information Send TOV Information CMS Disclaimer: This information is a summary of the final rule implementing the National Physicians Payment Transparency Program (Medicare, Med
Slide 46: Questions and Contacts
Questions and Questions and Contacts Discussion Shantanu Agrawal, MD, MPhil Medical Director Director, Data Sharing and Partnership Group [email protected] Anita Griner, MBA, PMP Deputy Director, Data Sharing and Partnership Group [email protected] Helpdesk: [email protected]