PHYSICIAN PAYMENT SUNSHINE ACT Physician Financial Transparency Reprts OVERVIEW FOR OPHTHALMOLOGY On February 1, the Centers fr Medicare & Medicaid Services (CMS) released a lng-awaited rule that wuld require all pharmaceutical, medical device and bipharmaceutical cmpanies t reprt transfers f value t the U.S. gvernment. The infrmatin will be publicly reprted t the Open Payments website. TOPIC KEY POINTS START DATE FOR COLLECTING/TRACKING August 1, 2013 t December 31, 2013: Manufacturers are required t begin cllecting and tracking payment, transfer, and wnership infrmatin. They are required t reprt fr the full calendar year starting in 2014. MUST REPORT TO CMS BY March 31, 2014: Manufacturers must reprt 2013 data t CMS. PUBLICATION OF REPORTS September 30, 2014 and June 30 in future years WHO REPORTS PAYMENTS MADE TO COVERED RECIPIENTS? Applicable Grup Purchasing Organizatins (GPO) Applicable Manufacturers WHO IS A COVERED RECIPIENT? Physicians : Dctrs f medicine and stepathy, dentists, pdiatrists, ptmetrists, and chirpractrs wh are legally authrized t practice by the State in which they practice The definitin applies regardless f whether the physician is enrlled in Medicare and as lng as the physician has a current license t practice. Nt included as a cvered recipient: Medical residents Nn-physician prviders such as nurse practitiners A bna-fide emplyee f the applicable manufacturer
WHAT MUST BE REPORTED? PAYMENT AND TRANSFER OF VALUE CATEGORIES The fllwing frms f payment are required t be reprted by the applicable manufacturer: Cash r a cash equivalent In-kind items r services Stck, a stck ptin, r any ther wnership interest, dividend, prfit, r ther return n investment Any ther frm f payment r ther transfer f value Cnsulting fees Cmpensatin fr serving as faculty r as a speaker fr an accredited and certified medical educatin prgram (CME) Cmpensatin fr serving as faculty r as a speaker fr a nn-accredited and nn-certified medical educatin prgram Hnraria Gift Entertainment Fd and beverage * Travel (including the specified destinatins) Educatin Research*** Charitable cntributin Ryalty r license Current r prspective wnership f investment interest Grant *The per-persn value f a meal is calculated based n cvered recipients that actually partake in the fd r beverages prvided. ***The Act (the ACA) allws fr delays in publicatin f payments/transfer f value fr designated research related t the develpment f a new prduct r applicatin t prtect cnfidential, prprietary activities. FINANCIAL TRANSFERS Direct Manufacturers f a drug, device, bilgical, r medical supplies participating in federal health care prgrams will have t reprt t CMS any direct payments r transfers f value t physicians and/r teaching hspitals f $10 r mre. (12 exceptins where a direct payment r transfer f value is nt subject t reprting as listed abve) Third party There are certain transfers nt made directly t physicians that are subject t reprting (called indirect transfers). Transfers r payments that the physician specifies shuld be given r paid t anther persn r entity wuld be reprtable, s t wuld any transfer r payments that anther persn indicates are being made n behalf f the physician. CMS requires reprting even thugh a physician des nt receive the payment r transfer. Indirect Anther reprtable indirect transfer includes when manufacturers make a payment t a third party, such as a physician rganizatin, and then requires, instructs, r directs the payment r transfer f value t be prvided t a specific physician r intended fr physicians (in the latter case withut regard t whether specific physicians are identified in advance). Ownership Manufacturers and GPOs participating in federal health care prgrams will have t reprt t CMS certain wnership interests held by physicians and their
immediate family members. Hwever, there are certain wnership interests, such as securities, which: (1) may be purchased n terms generally available t the public; (2) are listed n a stck exchange; and (3) have qutatins that are published n a daily basis. These are nt reprtable wnership interests. ACTIVITIES EXCLUDED FROM REPORTING Payments r ther transfers f value less than $10, except when the ttal annual value f payments r ther transfers f value prvided t a cvered recipient exceeds $100 Small incidental items (e.g., pens r ntepads) that are under $10 that are prvided at large scale cnferences and similar large scale events are excluded frm aggregate tracking and reprting Educatinal materials that directly benefit patients r are intended fr patient use* Payments r ther transfers f value prvided t a third party (e.g., physician prfessinal rganizatin) that are distributed t a cvered recipient, but the applicable manufacturer r GPO des nt require, instruct, direct r therwise cause the third party t prvide the payment t a cvered recipient Payments r ther transfers f value prvided as cmpensatin t a speaker f an accredited r certified cntinuing educatin prvider event supprted by an applicable manufacturer ** Attendees at an accredited r certified cntinuing educatin event whse fees have been subsidized thrugh the CME rganizatin by an applicable manufacturer *** Buffet meals, snacks, sft drinks, r cffee made generally available t all participants f a large-scale cnference r similar large-scale event Discunts, including rebates In-kind items fr the prvisin f charity care Prduct samples Shrt-term lan f cvered device (n mre than 90 days) EXCEPTIONS TO EXCLUSIONS 1. Educatinal materials that directly benefit patients r are intended fr patient use.* The exclusin des nt include educatinal materials (e.g., textbks, jurnal reprints) prvided t cvered recipients fr their wn educatin and that d nt "directly" benefit patients. 2. Payments r ther transfers f value prvided as cmpensatin t a speaker f an accredited r certified cntinuing educatin prvider event supprted by an applicable manufacturer ** ** Exclusin nly applies if: Accreditatin r certificatin f the cntinuing educatin prvider cmes frm the AACME, AAFP, ADA, AMA r AOA, The applicable manufacturer des nt pay the speaker directly (payment ges thrugh the educatinal prvider), and The applicable manufacturer des nt select the cvered recipient speaker and prvide the third-party prvider with a distinct set f speakers t be cnsidered. 3. Attendees at an accredited r certified cntinuing educatin event whse fees have been subsidized thrugh the CME rganizatin by an applicable manufacturer *** ***Any travel r meals prvided by an applicable manufacturer t specified cvered recipients assciated with these events must be reprted under the apprpriate nature f payment categries.
CME WHAT WILL BE DONE WITH REPORTED INFORMATION? PENALTIES FOR NON- COMPLIANCE? Payments r ther transfers f value prvided as cmpensatin fr speaking at a cntinuing educatin prgram are nt required t be reprted, if all f the fllwing cnditins are met: (1) The event at which the cvered recipient is speaking meets the accreditatin r certificatin requirements and standards fr cntinuing educatin f ne f the fllwing: (i) ACCME; (ii) AAFP; (iii) ADA; (iv) AMA; r (v) AOA; (2) The applicable manufacturer des nt pay the cvered recipient speaker directly; and (3) The applicable manufacturer des nt select the cvered recipient speaker r prvide the third party (such as a cntinuing educatin vendr) with a distinct, identifiable set f individuals t be cnsidered as speakers fr the cntinuing educatin prgram. The majrity f the infrmatin cntained in the transparency reprts will be available n a public, searchable website. By statute, physicians are prvided, at a minimum, 45 days t review their wn cnslidated transparency reprt and make crrectins befre the reprt is made public. Physicians have additinal time, cumulatively tw years, t dispute reprts even after the reprts are made public. If a physician makes use f the dispute prcess, the public data will be marked as disputed in the public database. Only applicable manufacturers and GPOs are vulnerable t the prescribed civil mnetary penalties (CMPs). PHYSICIAN PORTAL CMS will launch the prtal allwing physicians t sign up t receive ntice f when their reprt is available. Prtal als allws physicians t cntact manufacturers if they want t dispute the accuracy f the infrmatin. CAN PHYSICIANS REVIEW THE DATA AND MAKE CORRECTIONS? PUBLIC WEBSITE 45 days t review and initiate disputes: Cvered recipients and physician wners and investrs may register and then sign int a secure website and review the data submitted by applicable manufacturers and applicable GPOs n their behalf and chse t dispute certain payments r ther transfers f value, r wnership f investment interests. Infrmatin frm the current and previus cmpleted reprting year will be available fr review. 15 days additinal t reslve disputes The website will clearly state that disclsure f a payment r ther transfer f value n the website des nt indicate that the payment was legitimate nr des it necessarily indicate a cnflict f interest r any wrngding. The site will als cntain access t FAQs and ther methds t help users find and understand this infrmatin. Based n statute, the website will nt cntain the physician Natinal Prvider Identifier (NPI); it will allw fr searches acrss multiple fields and be dwnladable. HOW TO PREPARE Update yur disclsures regularly. Ensure that all financial disclsures and cnflict f interest disclsures are current and updated regularly. If yu have a NPI, update the infrmatin and ensure yur specialty is crrectly designated. Physicians wh have an NPI shuld ensure all infrmatin in the NPI enumeratr database is current and regularly updated as needed. This infrmatin will be used by industry, amng ther unique
HOW TO CHALLENGE FALSE, INACCURATE OR MISLEADING REPORTS ADDITIONAL INFORMATION identifiers, t ensure that they have accurately identified yu. Infrm yur industry cntacts that yu want nging ntice f what they reprt t the gvernment. Ask all manufacturer and grup purchasing rganizatin representatives with whm yu interact t prvide yu with ntice and an pprtunity t review and, if necessary, crrect all infrmatin that they intend t reprt befre it is submitted t the federal gvernment. Physicians will have at least 45 days nce the Centers fr Medicare & Medicaid Services (CMS) prvides access t individual physicians cnslidated industry reprts via an nline prtal t challenge reprts. Access will nt ccur until after the calendar year has cme t a clse. The prtal will allw physicians t cntact the manufacturer(s)/grup purchasing rganizatins (GPOs) that submitted inaccurate, misleading r false infrmatin in rder t reslve disputed submissins. If a physician and manufacturer(s)/gpo(s) cannt reslve the dispute, they are prvided an additinal 15 days befre the reprt is made public t try t achieve reslutin. If reslutin is still nt reached, the disputed infrmatin will be flagged, but the reprt will be psted n the public web page CMS develps fr such reprts. Physicians are als able t seek crrectin r cntest reprts fr tw years after access has been prvided t a reprt with disputed infrmatin. Once CMS establishes the nline prtal, physicians will be urged t sign up in rder t receive direct ntice when the reprts are made public. Yu shuld check with any manufacturer frm which yu have received payment r any item f value t see what infrmatin they are tracking and intend t reprt. If yu hld any wnership interests in a manufacturer r GPO, yu shuld als check t ascertain what wnership interest(s) they intend t reprt. (Ownership r investment interests in publicly traded security and mutual funds are excluded frm reprting.) CMS Physician Payment Sunshine Rule website at www.cms.gv/regulatins-and-guidance/legislatin/natinal- Physician-Payment- Transparency-Prgram/index.html