1

Which trip u are

planning

Sorry Sir ,Its tough to arrange….

Hello Doctor…

I'm with a new drug.

So????

Because of SUNSHINE

OkWhy???What???

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PHYSICIAN PAYMENT SUNSHINE ACT(PPSA)

PRUTH

VIRAJ

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FLOW OF PRESENTATIONWHAT ??WHEN??WHY??

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PPSA

Reports of payments and other transfers of value” worth $10 or more to an individual doctor must be tracked, and also any doctor who receives $100 or more in a year

Finally all this information publicly reported on a searchable govt. website starting Sept. 30, 2014

Simply, Act reveals financial relationships between physicians and pharma companies.

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PPSA enacted as section 6002 under PPACA by American President:

BARACK OBAMA in 2010

PPACA(Patient Protection and Affordable Care Act)

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Before 2010 In 2007, 699 doctors in Minnesota received more than $10,000 each in direct payments from drug companies. 123 physicians received more than $100,000 each, according to a 2007 New York Times report.

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2008:The prescribing habits of 2 groups of 10 doctors were tracked before and after they went on a free luxury vacation from separate drug companies.

1.The trip for the 2nd group of doctors was sponsored by the makers of an I.V Heart medication. 2.Before the trip, doctors prescribed an average of 34 units. After the trip, it rose to 87 units

1.Doctors in the 1st group, whose trip was sponsored by the makers of an I.V Antibiotic, prescribed 81 units of the drug before the trip and 272 units afterward.

New York Times report.

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The diabetes drug Avandia(GSK) as a good example of how obscured financial ties can harm patients.

The drug is controversial and is estimated to have caused 83,000 heart attacks in the United States alone

Academics and doctors who said heart attacks weren't a problem were over three times more likely to have received money from the pharmaceutical industry

AVANDIA STORY

1 example

2010

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Chronological moves

2010, Mar 23rd PPSA becomes

law

2013, Feb 1st CMS released

final rule on the Sunshine Act

from 2013, Aug 1st Companies must begin collecting Sunshine Act

information of 2013

2014, Mar 31st Companies must

report 2013 data to CMS

CMS : Centers for Medicare & Medicaid Services , U.S gov.

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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 the United States, or in a territory or commonwealth of the United States;

Who is Responsible to Report Required Information?

Applicable manufacturers

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Required Item Additional Required Descriptors

The name of the covered recipient(physicians who are legally authorized to practice by the State in which they practice)

Also includes the business address of the covered recipient and, in the case of a covered recipient who is a physician, the specialty and National 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 covered recipient

-

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 other ownership interest, dividend, profit or other return on investment;(d)any other

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A description of the nature of the payment or other transfer of value, indicated (as appropriate for all that apply) as:

Specifically:(I) consulting fees;(II) compensation for services other than consulting;(III) honoraria;(IV) gift;(V) entertainment;(VI) food;(VII) travel (including the specified destinations);(VIII) education;(IX) research;(X) charitable contribution;(XI) royalty or license;(XII) current or prospective ownership or investment interest;(XIII) direct compensation for serving as faculty or as a speaker for a medical education program;(XIV) grant; or(XV) any other nature of the payment or other transfer of value

Note : Act allows for delays in publication of payments/transfer of value for designated research related to the development of a new product or application to protect confidential, proprietary activities

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Penalties for noncompliance

Between $1,000 and $10,000 for each payment or other TOV or ownership or investment interest not reported as required

up to an annual maximum fine of $150,000

Companies not reported due to some problems

Companies not reported due to some problems

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Company Not reported

knowingly

Company Not reported

knowingly

Fines will increase to between $10,000 and $100,000 for each payment or other TOV not reported as required

up to an annual maximum fine of $1,000,000

Penalties for noncompliance

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EXCLUSIONSFROM ACT

items like product samples not intended for resale and “90-day try before you buy” type

scenarios

payments under $10 not exceeding $100 per year)

manufacturer pays a physician for providing

patient care to its employees

This is all about act NEXT….???

1.In-Kind items for the provision of charity care2.Attendees at accredited/certified continuing education events be excluded

Buffet meals, snacks, soft drinks, or coffee made generally available to all participants of a large-scale conference or similar event conference or similar large-scale event

In most companies, approximately 80% of HCP transactions are recorded in the expense system.

Although these transactions comprise only 20% of the total HCP spend. Not surprisingly.

HCP : Health Care Practitioner /Physician

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Some physicians have expressed concern that their reputations could be damaged

Dissuading physicians from joining efforts to develop and test new products

The medical device industry is often highly dependent on “hands on” physician interaction and collaboration from beginning to end.

Impact on relationship between manufacturers and physicians

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Purpose Of Act

Facilitate transparency into the financial relationships between industry and physicians and

teaching hospitals.

The cost of such marketing expense are embedded in the cost of drugs

Empower informed decision-making for consumers of healthcare

Prevent inappropriate influence on research, education, and clinical decision-making

Physicians will prescribe more safer drugs

TRANSPARENCY

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A 50 pages set of objections from Big Pharma Member companies

PhRMA argued that the Sunshine Act should be applied only to manufacturers making drugs in the U.S

The U.S. members of PhRMA sell and distribute drugs that are manufactured by their subsidiaries, and a great many of those subsidiaries are not U.S.-based.

2011:ACT opposed by MNCs

PhRMA : Pharmaceutical Research And Manufacturers Of America

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Arguments

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 then promote your brand?) Thats why companies often offer gifts, cash incentives to doctors or take them along with family members to free foreign trips

Pharma products are different from consumer products.

"It is hard for a conscientious physician today to learn the truth about which drugs work and how safe they are.

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India: started??

June 2012,Congress MP Jyoti Mirdha made a complaint to DoP’s that she has got evidence to prove that drug companies did not adhere to the code proposed by the department

The documents consisting travel details of a group of 11 doctors and their families from M.P, who went on a 7-day long trip to London and Scotland between May 24 and May 31 , apart from the travel agency Zenith Hospitality, clearly mentions INTAS - a pharmaceutical company based in Ahmedabad which manufactures psychiatric drugs.

All the 11 doctors, who went on the trip, are neurologists

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Continued.. DoP’s had gone meeting with drug makers and discussed

regarding implementation of Drug Marketing Code and making it is mandatory to them

This meeting also attended by the members of MCI(the body that regulates doctors and medical colleges in the country)

"It's a clear cut violation of medical ethics and MCI rules. The doctors are prohibited from accepting gifts in cash or any other kind from any pharma companies”

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MCI PENALTY LIST(For Doctors Who Accepts Gifts)

GIFTS WORTH punishments

Rs 1,000-5,000 Censure (Harsh criticism or disapproval)

Rs 5,000-10,000 Delicensed for 3 months

Rs 10,000-50,000 Delicensed for 6 months

Rs 50,000-1 lakh Delicensed for 1 year

Above Rs 1 lakh Delicensed for longer than 1 year

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Last year the DoP’s floated the uniform drug marketing code of conduct but made it voluntary despite calls from drug industry that it would be ineffective if not made compulsory with punitive provisions

The code restricts companies from offering or promising gifts, pecuniary advantages or benefits in kind to physicians. They also cannot sponsor doctors or their family members’ travel, entertainment, sporting or leisure events, directly or indirectly

Continued…

Free lunches, trips & other gifts may be influencing which drug you're prescribed.

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To shine light on this culture, sunshine laws are necessary

Its necessary to implement this act in India too..

Thank you

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U.PRUTHVIRAJROLL.NO.43

MBA(Pharm.) 2nd Semester

NIPER-MOHALI

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