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Physician Payment Sunshine Act(PPSA)

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PPSA is a new act... recently passed in USA.
To monitor the culture between pharma companies and doctors like receiving incentives ,gifts and prescribing those companies drugs
Due to this act , people will be more safer with drugs and healthcare cost burden will reduced...and to know more about act... see the presentration..

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Physician Payment Sunshine Act(PPSA)

  1. 1. Which tripu areplanningSorry Sir ,Its tough toarrange….HelloDoctor…Im with anew drug.So????Because ofSUNSHINEOkWhy???What???1
  2. 2. PHYSICIAN PAYMENT SUNSHINE ACT(PPSA)2
  3. 3. FLOW OF PRESENTATIONWHAT ??WHEN??WHY??3
  4. 4. PPSA Reports of payments and other transfers of value” worth $10or more to an individual doctor must be tracked, and also anydoctor who receives $100 or more in a year Finally all this information publicly reported on a searchablegovt. website starting Sept. 30, 2014Simply, Act reveals financial relationships between physicians andpharma companies.4
  5. 5. PPSA enacted as section 6002 under PPACAby American President: BARACK OBAMA in20105PPACA(Patient Protection and Affordable Care Act)
  6. 6. Before 2010In 2007, 699 doctors inMinnesota received more than$10,000 each in direct paymentsfrom drug companies. 123physicians received more than$100,000 each, according to a2007 New York Timesreport.6
  7. 7. 2008:The prescribing habits of 2 groups of 10 doctors were trackedbefore and after they went on a free luxury vacation from separate drugcompanies.1.The trip for the 2nd group ofdoctors was sponsored by themakers of an I.V Heartmedication.2.Before the trip, doctorsprescribed an average of 34units. After the trip, it rose to87 units1.Doctors in the 1st group,whose trip was sponsored bythe makers of an I.VAntibiotic, prescribed 81units of the drug before thetrip and 272 units afterward.7New York Times rep
  8. 8. 8 The diabetes drug Avandia(GSK) as a good example of how obscuredfinancial ties can harm patients.The drug is controversial and is estimated to have caused 83,000 heartattacks in the United States aloneAcademics and doctors who said heart attacks werent a problem were overthree times more likely to have received money from the pharmaceuticalindustryAVANDIA STORY1example2010
  9. 9. Chronological moves2010, Mar 23rdPPSA becomeslaw2013, Feb 1stCMS releasedfinal rule on theSunshine Actfrom 2013, Aug 1stCompanies must begincollecting Sunshine Actinformation of 20132014, Mar 31stCompanies mustreport 2013 data toCMS9CMS : Centers for Medicare & Medicaid Services , U.S gov.
  10. 10. 1.An applicable manufacturer is engaged in the production,preparation, propagation, compounding, or conversion of a drug,device, biological, or medical supply for sale or distribution in theUnited States, or in a territory or commonwealth of the United States;Who is Responsible to Report Required Information?Applicable manufacturers10
  11. 11. Required Item Additional Required DescriptorsThe name of the covered recipient(physicianswho are legally authorized to practice by theState in which they practice)Also includes the business address of thecovered recipient and, in the case of a coveredrecipient who is a physician, the specialty andNational Provider Identifier of the coveredrecipient.The amount of the payment orother transfer of value_The date(s) on which the paymentor other TOV was provided to the coveredrecipient-A description of the form of thepayment or other transfer of value,indicated (as appropriate for all thatapply) as:Specifically, (a) cash or a cash equivalent;(b) in-kind items or services;(c) stock, a stock option, or any otherownership interest, dividend, profit or otherreturn on investment;(d)any other 11
  12. 12. A description of the nature of the paymentor other transfer of value, indicated (asappropriate for all that apply) as:Specifically:(I) consulting fees;(II) compensation for services other thanconsulting;(III) honoraria;(IV) gift;(V) entertainment;(VI) food;(VII) travel (including the specifieddestinations);(VIII) education;(IX) research;(X) charitable contribution;(XI) royalty or license;(XII) current or prospective ownership orinvestment interest;(XIII) direct compensation for serving asfaculty or as a speaker for a medicaleducation program;(XIV) grant; or(XV) any other nature of the payment orother transfer of valueNote : Act allows for delays in publicationof payments/transfer of value fordesignated research related to thedevelopment of a new product orapplication to protect confidential,proprietary activities12
  13. 13. Penalties for noncomplianceBetween $1,000 and $10,000 for eachpayment or other TOV or ownershipor investment interest not reported asrequiredup to an annual maximumfine of $150,000Companies notreported due tosome problems13
  14. 14. Company NotreportedknowinglyFines will increase to between $10,000and $100,000 for each payment or otherTOV not reported as requiredup to an annual maximum fine of$1,000,000Penalties for noncompliance14
  15. 15. EXCLUSIONSFROM ACTitems like productsamples not intended forresale and “90-day trybefore you buy” typescenariospayments under $10 notexceeding $100 per year)manufacturer pays aphysician for providingpatient care to its employeesThis is all about act NEXT….???1.In-Kind items for theprovision of charity care2.Attendees ataccredited/certifiedcontinuing education eventsbe excludedBuffet meals, snacks, softdrinks, or coffee made generallyavailable to all participants of alarge-scale conference orsimilar event conference orsimilar large-scale event15
  16. 16.  In most companies, approximately 80% of HCPtransactions are recorded in the expense system.Although these transactions comprise only 20% of thetotal HCP spend. Not surprisingly.HCP : Health Care Practitioner /Physician
  17. 17.  Some physicians have expressed concern that their reputations could bedamaged Dissuading physicians from joining efforts to develop and test newproducts The medical device industry is often highly dependent on “hands on”physician interaction and collaboration from beginning to end.Impact on relationship betweenmanufacturers and physicians17
  18. 18. Purpose Of Act18Facilitate transparency into the financialrelationships between industry and physicians andteaching hospitals.The cost of such marketing expense are embeddedin the cost of drugsEmpower informed decision-making for consumersof healthcarePrevent inappropriate influence on research,education, and clinical decision-makingPhysicians will prescribe more safer drugsTRANSPARENCY
  19. 19.  A 50 pages set of objections from Big Pharma Member companies PhRMA argued that the Sunshine Act should be applied only tomanufacturers making drugs in the U.S The U.S. members of PhRMA sell and distribute drugs that aremanufactured by their subsidiaries, and a great many of thosesubsidiaries are not U.S.-based.192011:ACT opposed by MNCsPhRMA : Pharmaceutical Research And Manufacturers Of America
  20. 20. Arguments20Industry executives says the practice is a legacy of the drug industry(since all companies sell the same drug under various brands. “How do you thenpromote your brand?)Thats why companies often offer gifts, cash incentives to doctors or take them along with familymembers to free foreign tripsPharma products are different from consumer products."It is hard for a conscientious physician today to learn the truth about whichdrugs work and how safe they are.
  21. 21. India: started?? June 2012,Congress MP Jyoti Mirdha made a complaint toDoP’s that she has got evidence to prove that drug companiesdid not adhere to the code proposed by the department21The documents consisting travel details of a group of 11 doctors and their familiesfrom M.P, who went on a 7-day long trip to London and Scotland between May 24 andMay 31 , apart from the travel agency Zenith Hospitality, clearly mentions INTAS - apharmaceutical company based in Ahmedabad which manufactures psychiatric drugs.All the 11 doctors, who went on the trip, are neurologists
  22. 22. Continued.. DoP’s had gone meeting with drug makers and discussedregarding implementation of Drug Marketing Code andmaking it is mandatory to them This meeting also attended by the members of MCI(the bodythat regulates doctors and medical colleges in the country)"Its a clear cut violation of medical ethics and MCI rules. The doctors areprohibited from accepting gifts in cash or any other kind from any pharmacompanies”22
  23. 23. MCI PENALTY LIST(For Doctors Who Accepts Gifts)GIFTS WORTH punishmentsRs 1,000-5,000 Censure (Harsh criticism or disapproval)Rs 5,000-10,000 Delicensed for 3 monthsRs 10,000-50,000 Delicensed for 6 monthsRs 50,000-1 lakh Delicensed for 1 yearAbove Rs 1 lakh Delicensed for longer than 1 year23
  24. 24.  Last year the DoP’s floated the uniform drug marketing code ofconduct but made it voluntary despite calls from drug industrythat it would be ineffective if not made compulsory with punitiveprovisions The code restricts companies from offering or promising gifts,pecuniary advantages or benefits in kind to physicians. They alsocannot sponsor doctors or their family members’ travel,entertainment, sporting or leisure events, directly or indirectlyContinued…Free lunches, trips & other gifts may beinfluencing which drug youre prescribed.24
  25. 25. To shine light on this culture, sunshine laws are necessaryIts necessary to implement this act in India too..25
  26. 26. Thankyou
  27. 27. 27U.PRUTHVIRAJROLL.NO.43MBA(Pharm.) 2ndSemesterNIPER-MOHALI

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