HCCA CLINICAL PRACTICE COMPLIANCE CONFERENCE

Transcription

1 HCCA CLINICAL PRACTICE COMPLIANCE CONFERENCE CMS Open Payments Formerly Known as the Sunshine Act October 13, 2014 Philadelphia, Pennsylvania PRESENTATION OBJECTIVES Open Payment Regulations Reporting Requirements who, what, when Exclusions Payment Reconciliations Process Timing Disputes Focus on physicians not manufacturers or teaching hospitals most common situations 2 1

2 IT LOOKS WORSE THAN IT IS Today we re only reviewing the basics of the Open Payments regulations not everything on all the slides they re a resource for future questions! 3 DISCUSSION QUESTIONS Do you have conflict of interest policies? Did you receive/provide any Open Payments education? From or to whom? Did you check your data before it became public? Any surprises? Any frustrations? What type of payment records do you keep? Did you use the Open Payments app? 4 2

3 DISCUSSION QUESTIONS Did you understand what would and would not be reported? Have you looked at your public data? Any surprises? Do you routinely disclose relationships to patients? How? Have you gotten questions from patients? 5 BACKGROUND -ASSOCIATION OF AMERICAN MEDICAL COLLEGES June 2010 Report of the Task Force on Financial Conflicts of Interest in Clinical Care * Having conflict of interest policies and procedures is good medicine. 6 3

4 AAMC FINDINGS * Utilization increases with ownership Gifts affect decision making 7 AAMC FINDINGS How institutions act is also an influence, like faculty and resident physicians, on students. Especially for those serving in direct leadership roles for faculty physicians (division chiefs and department chairs), addressing conflicts of interest is critically necessary. 8 4

5 AAMC FINDINGS It s imperative for transparency in relationships among academic medicine, physicians, and industry...with respect to public Web sites the accuracy, freedom from inconsistency, and ease of understanding of the information disclosed will determine whether this format for achieving transparency has any real value. manufacturer manufacturer manufacturer 9 ADDRESSING TRANSPARENCY Primary Methods - Websites Hospital websites Physicians Manufacturers Consumer organization websites Brochures, letters to patients Posted notices: check-in, offices, exam rooms 10 5

6 WEBSITES AREN T NEW 11 FEELING BETTER? No? Maybe you need a little sunshine 12 6

7 OPEN PAYMENTS PREVIOUSLY -SUNSHINE ACT Physician Payment Provision of the Patient Protection and Affordable Care Act of 2009 Became law on March 23, 2010; public comments closed February 17, Initially reporting of payments made in implementation delayed until August OPEN PAYMENTS -PURPOSE Promote transparency into the financial relationships physicians and teaching hospitals have with drug and device manufacturers No assumptions or conclusions about the payments just data CMS will simply make the program available to the public to create transparency and allow interested stakeholders to analyze, monitor, and use the data. * 14 7

8 PURPOSE transparency will shed light on the nature and extent of the relationships that exist and hopefully discourage development of inappropriate relationships. * 15 DISCUSSION Do you have conflict of interest policies? Are policies the same for physicians and non-physicians? Did you receive/provide education? To/From Whom? 16 8

9 HOW OPEN ARE THE PAYMENTS: WHO, WHAT AND WHEN Who Reports: Drug, biological and medical supply and device manufacturers to report What s Reported: All payments, transfers of value, ownership interests Payments to Whom: Physicians and teaching hospitals When: Payments made between January 1 and December 31 When: Reports are due by March WHO REPORTS PAYMENTS Reports Payments and Transfers of Ownership - Manufacturers of drugs, devices, biological or medical supplies for which payment is available under Medicare, Medicaid, or the Children s Health Insurance Program (CHIP) 18 9

10 WHO Group Purchasing Organizations (GPOs) Operate in the United States, or in a territory, possession or commonwealth of the US 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 itself Includes GPOs that - Negotiate contracts for their members, Entities that purchase covered drugs, devices, biologicals, and medical supplies for resale or distribution to groups of individuals or entities 19 WHAT S REPORTED Cash and cash equivalents Stock Stock options Partnership shares Limited liability company membership(s) Loans Bonds Other financial instruments 20 10

11 PAYMENTS TO WHOM Physicians and their immediate family members Spouse Natural or adoptive parent, child or sibling Stepparent, stepchild, stepbrother stepsister Father-, mother-, daughter-, son-, sister-in-law Grandparent or grandchild Spouse of grandparent or grandchild 21 WHO S APHYSICIAN? Doctor of Medicine Osteopathy Dentistry Dental Surgery Podiatry Optometry Chiropractic Medicine Fellows 22 11

12 PAYMENTS NOT REPORTED Excludes Physicians employed by the reporting manufacturer Physicians employed by a teaching hospital when teaching hospital is recipient of payment Residents Nurse Practitioners Physician Assistants 23 DETAILS REPORTED Manufacturers report physician s Name First, last middle initial Business address Primary practice address NPI Individual not group Specialty Date of payment Type of payment (not required) 24 12

13 WHAT ELSE IS REPORTED? Related drug, device, biological or medical supply If payment is for education, marketing or research Name under which product is marketed Form and nature of payment 25 FORM OF PAYMENT Categories Cash or cash equivalent In-kind items or services Stock, stock option or other ownership interest, dividend, profit or other return on investment Any other form of payment or other transfer of value 26 13

14 NATURE OF PAYMENT Categories Consulting Fees Compensation for services other than consulting Honoraria Gift Entertainment Food and beverage Travel and lodging 27 NATURE OF PAYMENT Categories continued Education Research Charitable contribution Royalty or license Current or prospective ownership or investment interest 28 14

15 NATURE OF PAYMENT Categories continued Compensation for serving as faculty or as a speaker for an unaccredited and non-certified continuing education program. Compensation for serving as faculty or as a speaker for an accredited or certified continuing education program Grant Space rental or facility fees (primarily teaching hospitals) 29 WHEN MANUFACTURERS REPORT Calendar year and due by March 31 of the following year First year only - payments made between August 1 and December 31, 2013 needed to be reported by March 31, 2014 Information should be publicly available by June 30 Year 1 Only - September 30, 2014 Physicians have NO reporting requirements! 30 15

16 Specifics Related to Certain Payments 31 CHARITABLE CONTRIBUTIONS Paid directly to charity, not for services provided Example: Donation to a non-profit hospital Payments for physician services, redirected by the physician to a charity, are NOT charitable contributions. The nature of the payment would not change. Example: Payments for consulting services redirected to a charity are reported as consulting

17 FOOD AND BEVERAGE Group setting divide the value of the meal by the number of participants; report if the per person cost exceeds $10 threshold Includes non-physicians Excludes physicians who don t eat/drink Meals dropped off reported If don t want meals will need to make it clear to manufacturer Conferences not included if it s impossible to determine who partook Example: buffet meal, coffee, snacks 33 MEAL CALCULATION EXAMPLES Example 1: Educational Dinner Cost: $3,000 Participants: 50 (30 physicians, 20 non-physicians) Cost per Participant: $60 reportable for 30 physicians Example 2: Educational Dinner Cost: $3,000 Participants: 350 (200 physicians, 150 nonphysicians) Cost per participant: $8.57 not reportable 34 17

18 COMPENSATION FOR MEDICAL EDUCATION FACULTY OR SPEAKER Accredited and certified continuing education payments Nature of Payment: Compensation for serving as faculty or as a speaker for an accredited or certified continuing education event. Excludes subsidies (reduced tuition) by CME (nonmanufacturer) organizer All other compensation as a speaker or faculty Nature of Payment: Compensation for serving as a faculty or as a speaker for an unaccredited and noncertified education event 35 ENTERTAINMENT & GIFTS Entertainment Attendance at Recreational Cultural Sporting Other events Gifts Items that don t fit into another category Does not include tickets to events that s entertainment even if the ticket was a gift 36 18

19 RESEARCH Definition *: a systematic investigation designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social sciences research. This term encompasses basic and applied research and product development. Includes Pre-clinical research and FDA Phases I-IV research Investigator-initiated investigations Written agreement OR contract OR protocol If payments don t meet above requirements then report under a different category 37 EXCLUSIONS NOT REPORTED Existing personal relationships Payments or transfers of value less than $10 Unless total annual value exceeds $100 Threshold will increase annually based on CPI Small incidental items under $10 provided at conferences don t need to be tracked 38 19

20 EXCLUSIONS Educational materials that directly benefit patients or are intended for patient use Examples: anatomical parts to use for patient education, brochures, flash drives with data Textbooks to physicians are reportable. Must be educational not marketing or promotional Discounts and rebates Samples for use by patients Includes drugs, supplies, devices Items or coupons for items Physician and manufacturer agree, in writing, the products will be provided to the patient 39 EXCLUSIONS In-kind items for the provision of charity care Items provided for patients who cannot pay; there s no expectation of payment If item is given to all patients, including those who can pay, it is reportable Physician and manufacturer agree, in writing, that items will be used only for charity care 40 20

21 EXCLUSIONS Short term loans of devices, multiple and single use, and related supplies Loan of no more than 90 days for the entire year Consecutive days or sporadically More than 90 days excess is reportable Items and services provided under a contractual warranty, contractual maintenance agreement, or product recall Physician participating as a subject (patient) in a research study 41 EXCLUSIONS Provision of healthcare to employees Includes employees and their families Manufacturer has on-site healthcare Physicians involved in civil or criminal action or administrative proceedings for a manufacturer 42 21

22 EXCLUSIONS Indirect payments manufacturer makes payment to third party; third party makes payment to physician. Manufacturer does not direct the payment or know identity of the recipient use is unrestricted Example 1: manufacturer pays consulting firm; consulting firm employs and pays physician Example 2 (reportable): physician requests payment to go to a third party third party provides payment to physician payment is reported under recipient s name 43 INDIRECT PAYMENTS Example 3 (reportable/not reportable): manufacturer gives funds to a professional organization to specifically award grants to physicians (use is restricted). Excluded manufacturer doesn t know name of recipient by June 30 of next calendar year Reported manufacturer learns name of recipient before second quarter of following year Reported manufacturer directs organization to provide grants to top X physicians manufacturer may not know names but should be able to determine Incumbent on third parties to track payments and report back to manufacturers 44 22

23 INDIRECT PAYMENTS FOR CME Payments made to a third party are not reported if all the following are met: Program meets accreditation/certification standards of ACCMA, AOA, AMA, AAFP or ADA CERP Manufacturer doesn t direct selection of speaker in any way (including suggesting list of speakers) Manufacturer doesn t directly pay the physician/speaker Example: vendor makes payment to AMA to compensate speakers at an accredited conference Suggests possible speakers reportable No involvement with speaker selection not reportable 45 REPORTING: MANUFACTURERS AND GPOS May voluntarily provide physicians with data before submitting it to CMS Required to be electronically submitted to CMS by the 90 th day of each calendar year March 31 for the previous calendar year Transactions are reported at the individual payment, transfer of value, ownership or investment interest level 46 23

24 DISCUSSION Types of payments received? Checked data before it became public? Any surprises? Frustrations? What payment records kept? Open Payments App? 47 DATA REVIEW Period of at least 45 days View own data only 2 years System was down a fair amount of time this year because of corrupt data (physician was able to see different physician s data same name) Review period extended to September 10, 2014* 48 * CMS extended the review period August 28,

25 DATA REVIEW CMS will announce the review and correction period with specific review instructions - via: list serves Online postings: CMS website and Federal Register Directly, likely by , to CMS registered physicians CMS registration isn t required but physician must be registered to review data 49 DATA REVIEW Register on CMS and Open Payments websites Both Apple and Google have apps to track your payments! Additional 15 days after 45 day review period to correct data Earlier the dispute identified more likely it is to be corrected Available data - all data submitted Payments or other transfers of value Ownership or investment interest 50 25

26 AGREE? DISAGREE? Physician is responsible for reviewing and initiating any dispute Done electronically Detail the dispute Include proposed resolution System flags transaction and notifies manufacturer 51 RESOLUTIONS AFTER 15 DAY REVIEW PERIOD If not resolved it s marked disputed Manufacturer s data are published Transactions are available throughout the year to review or dispute Resolutions reflected on public website after next data update (not after resolution) 52 26

27 PAYMENTS PUBLICALLY AVAILABLE First Year: September 30, 2014 Data from August 1 December 31, 2014 Future Years: June 30 Data from previous January 1 December DATA ELEMENTS PAYMENTS SEARCHABLE & DOWNLOADABLE * Manufacturer s name Covered recipient s (physician s) Name Specialty Practice location Amount of payment Date of payment Form of payment Nature of payment Name of related drugs, devices, biologicals or medical supplies NDCs of related drugs or biologicals Name of entity that received the payment if not the physician Statement of additional context - optional 54 27

28 DATA ELEMENTS RESEARCH SEARCHABLE & DOWNLOADABLE Name of entity receiving payment Total amount of research payment Name of study Name of related covered drugs, biologicals, devices or medical supplies NCDs of related covered drugs and biologicals Principal investigator Name Specialty Primary address Context of research ClinicalTrials.gov identifier (optional) 55 DATA ELEMENTS OWNERSHIP & INVESTMENT INTEREST SEARCHABLE & DOWNLOADABLE Manufacturer s name Covered recipient s (physician s) Name, specialty, location Ownership/investment interest by physician or family Dollar amount invested Value and terms of each ownership/investment interest Any payment provided to physician Amount, date, form, nature Names of covered DBDM NCD of drugs/biologicals Name of entity that received payment if not physician Voluntary statement of context 56 28

29 GOING FORWARD PLANNING FOR 2015 Keep documentation; get the app Calendars Meals, entertainment, events, gifts Copies of payments Copies of program agendas Receipts for reimbursed travel Entertainment ticket stubs Return unwanted items Keep return mailing receipts Save s requesting no gifts 57 GOING FORWARD Register to review data!! Dispute items as soon as identified. Notify patients in advance Letter Brochure Website Determine how you ll answer questions 58 29

30 DISCUSSION Did you understand what would/would not be reported? Have you looked at your public data? Any surprises? Do you routinely disclose relationship interests to patients? How? Have you gotten any questions from patients? Or anyone? 59 Questions? Comments? Thoughts? Before CMS Screen Shots 60 30

31 SPEAKER INFORMATION Jodie R. Caplan Carilion Clinic Roanoke, VA Registration & Open Payments Review Screen Shots 62 31

32 Start here set up user id and password

33 Access to Open Payments

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50 99 The End