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..

1. Which trip
u are
planning
Sorry Sir ,
Its tough to
arrange….
Hello
Doctor…
I'm with a
new drug.
So????
Because of
SUNSHINE
Ok
Why???
What???
1

2. PHYSICIAN PAYMENT SUNSHINE ACT
(PPSA)
2

3. FLOW OF PRESENTATION
WHAT ??
WHEN??
WHY??
3

4. 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.
4

5. PPSA enacted as section 6002 under PPACA
by American President: BARACK OBAMA in
2010
5PPACA(Patient Protection and Affordable Care Act)

6. 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.
6

7. 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.
7
New York Times rep

8. 8
 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

9. 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
9
CMS : Centers for Medicare & Medicaid Services , U.S gov.

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 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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11. 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 covered
recipient.
The amount of the payment or
other transfer of value
_
The date(s) on which the payment
or other TOV was provided to the covered
recipient
-
A description of the form of the
payment or other transfer of value,
indicated (as appropriate for all that
apply) 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 11

12. 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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13. 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
13

14. 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
14

15. EXCLUSIONS
FROM 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 care
2.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
15

16.  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

17.  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
17

18. Purpose Of Act
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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

19.  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.
19
2011:ACT opposed by MNCs
PhRMA : Pharmaceutical Research And Manufacturers Of America

20. Arguments
20
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.

21. 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
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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

22. 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”
22

23. 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
23

24.  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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25. To shine light on this culture, sunshine laws are necessary
Its necessary to implement this act in India too..
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26. Thank
you

27. 27
U.PRUTHVIRAJ
ROLL.NO.43
MBA(Pharm.) 2nd
Semester
NIPER-MOHALI