Thomas Sullivan President, Rockpointe March 2015 Thomas Sullivan - - PowerPoint PPT Presentation
Thomas Sullivan President, Rockpointe March 2015 Thomas Sullivan Former political consultant who founded Rockpointe, Inc., an accredited bio- medical education company in 1995 Authority in changing medical education environment and
Rockpointe, Inc., an accredited bio- medical education company in 1995
environment and economy
leading online coverage of the Sunshine Act, a resource informing the medical community on trends, threats and changing processes
educational purposes and should not be construed as legal advice
Massachusetts Data
Kohl of Wisconsin introduced unsuccessful versions of a Sunshine bill in 2007 and again in 2009, focused on public disclosure of the financial relationships between physicians and the pharmaceutical, device, and biologics industries.
larger Affordable Care Act in 2010 (Section 6002).
the task of creating the necessary regulations to implement it.
February 8, 2013.
“covered” drugs, devices, biologics, or medical supplies to report annually to the Secretary of HHS certain payments or other transfers
reporting of payments and transfers of value.
devices, biologicals, and medical supplies covered by Medicare, Medicaid, or CHIP are required to report on their transfers of value
– Report only physician ownership, investment interests – Definition includes physician owned distributors (PODs) that purchase products for resale
Covered recipients, including colon and rectal surgeons, have no reporting obligations. Only manufacturers are subject to Civil Monetary Penalties for noncompliance.
– MD’s, DO’s, Dentists, Dental Surgeons, Podiatrists, Optometrists,
– All physicians that have a current license regardless of whether enrolled with CMS, or whether treating patients
immediate family members
must be reported as indirect payments
applicable manufacturer (except ownership interest), residents, nurse practitioners, physician assistants, pharmacists, physicians in their capacity as payments
Teaching hospital
– Any Institution receiving payments under:
–
CMS publishes an annual list identifying the teaching hospitals that are affected (over 1200)
–
Does not include payments to non- healthcare departments at universities affiliated with hospital
–
Must report indirect payments as required
–Cash or cash equivalent –In-kind items or services –Stock, stock option, ownership interest –Dividend, profit or other return on investment
–If payment or transfer relates to marketing, education, or research of a drug, device, biological, or medical supply, the related product must also be identified
Travel Lodging Consulting Research Ownership Interests., Royalties and Licenses Gifts Entertainment Food and Beverage Speaking Education
immediate family members, with ownership interests in privately held companies with marketed products must be reported:
– Spouse – Natural or adoptive parent, child or sibling – Father, mother, daughter, son, brother or sister- in-law – Stepparent, stepchild, stepbrother, or stepsister – Grandparent or grandchild – Spouse of grandparent or grandchild
does not know of the relationship
relatives, worth $51,675,944
with an activity that meets the definition of research, and that are subject to a written agreement, contract, or research protocol, or both, are reported under “special rules.”
total amount of the study
to a CR by an AM under a product research or development agreement may be delayed from publication on the Web site.
– Manufacturer pays physician or hospital directly
– Manufacturer pays a 3rd party directly, the 3rd party then pays a physician or Hospital
unaware of identity of CR
>$100
coupons
directly benefit patients or intended for patient use, value of services to educate patients
warranty
CME speaker fees if the program was accredited by one of five specific bodies. CMS deleted this original language, but effectively incorporated the CME exemption for speakers and attendees at accredited CME events.
the [CME] event provider to provide the payment…to a covered recipient,” such payments are not reportable. CMS indicates manufacturers meet this threshold when they do not (1) select or pay the speaker directly, or (2) provide the CME provider with a distinct list of speakers to consider.
tuition fees provided to physician attendees that have been generally subsidized at continuing education events by manufacturers are not expected to be reported.”
register with the Open Payments system at cms.gov/openpayments in
public, resolve data disputes, and request data corrections during the 45-day review and dispute period.
manufacturer or GPO of the dispute. After being alerted, the AM
that needs to be changed will be re-reported. AMs and GPOs then have 15 days to resolve and submit corrections. Disputed data that is not resolved by the end of the 15-day period will be published on the public website, but will be marked as disputed.
hospitals registered to review their data
Entity Total Identified Yet to Be Reported Percent Missing
Physicians 546,000 360,000 186,000 34.1% Teaching Hospitals 1,360 873 487 35.8% AM’s and GPO’s 1,419 1379 40 02.8% Records 4,400,000, 2,700,000 1,700,000 38.7% Amounts $3.5 Billion $1.3 Billion $2.2 Billion 62.8%
Does not include $1.1 billion of disputes and delayed research (full total = $4.6 billion)
Source: Compiled from U.S. Department of Health & Human Services data
Citing data inconsistencies and uncertainty, the federal government withheld the names
hospitals for 40% of
chart shows the percent of money that was withheld.
– ProPublica 10/1/14
Less than $10, 366,113, 14% Between $10-$15, 875,887, 33% Between $15-$20, 465,816, 18% Between $20- $100, 562,241, 21% Greater than $100, 356,617, 14%
Payments Number <$1.00 24,897 <$.50 9,437 <$.01 646
Source: Compiled from U.S. Department of Health & Human Services data openpaymentsdata.cms.gov
Medicaid Services estimated that the program would cost physicians and industry
Source: Open Payments Final Rule, Federal Register February 2013
[VALUE], [PERCENTAGE] [VALUE], [PERCENTAGE]
Physicians Teaching Hospitals
Chiropractor 0% Doctor of Dentistry 8% Doctor of Optometry 0% Doctor of Osteopathy 2% Doctor of Podiatric Medicine 3% [CATEGORY NAME] [PERCENTAGE]
Source: Compiled from U.S. Department of Health & Human Services data openpaymentsdata.cms.gov
Courtesy Huron Consulting
Nature of Payments Total Percent of Total Research $1,486,242,674 60.34% Royalty or License $302,474,187 12.28% Services Other than Consulting $202,557,342 8.22% Consulting Fee $158,200,318 6.42% Food and Beverage $92,816,309 3.77% Travel and Lodging $74,075,322 3.01% Grant $38,126,886 1.55% Education $26,667,323 1.08% Honoraria $25,544,566 1.04% Gift $19,213,865 0.78% Faculty at Non Accredited Event $14,844,660 0.60% Current or prospective ownership or investment interest $10,567,522 0.43% Facility Fees (TH Only) $4,744,889 0.19% Speaking at Accredited Event $4,221,536 0.17% Charitable Contribution $2,531,755 0.10% Entertainment $157,333 0.01% Total $2,462,986,488
Source: Compiled from U.S. Department of Health & Human Services data openpaymentsdata.cms.gov
Category Nationwide % Total New Jersey % Total Research $175,614,096 42.18% $1,519,736 68.92% Royalty or License $147,707,114 35.48% $100,000 4.54% Grant $32,960,055 7.92% $72,040 3.27% Speaking/Faculty/NonCME $16,776,971 4.03% $134,872 6.12% Consulting Fee $14,402,011 3.46% $44,266 2.01% Gift $13,871,646 3.33% $77,678 3.52% Education $7,143,789 1.72% $44,097 2.00% Facility Fees (TH Only) $4,744,889 1.14% $79,155 3.59% Charitable Contribution $2,356,541 0.57% $111,650 5.06% Honoraria $174,567 0.04% $14,720 0.67% Food and Beverage $112,622 0.03% $6,453 0.29% Speaker/Faculty, Non Accred $13,002 0.00% $250 0.01%
Total $416,332,265 $2,204,917 0.53%
Raw Data: Courtesy of Huron Consulting
Rank Physician Specialty # Payments Total Average 1 Orthopedic Surgery 52,962 $73,165,243 $1,381 2 Internal Medicine 379,165 $24,562,672 $65 3 Cardiology 149,271 $21,797,429 $146 4 Neurology 82,503 $15,825,438 $192 5 Neurological Surgery 21,837 $13,507,585 $619 6 Gastroenterology 88,981 $13,468,983 $151 7 Psychiatry 84,901 $13,465,762 $159 8 Endocrinology, Diabetes and Metabolism 54,811 $12,195,751 $223 9 Family Medicine 387,290 $10,905,193 $28 10 General Surgery 37,268 $9,934,689 $267
Open Payments General Payment Database (Identified Records) 2013
Teaching Hospital Name
Total Payment % of Total
Masked by CMS $ 336,351.06 49.09% Ahs Hospital Corp. $ 54,126.67 7.90% Princeton Healthcare System $ 50,249.54 7.33% Deborah Heart And Lung Center $ 31,763.00 4.64% Robert Wood Johnson University Hospital, Inc $ 28,101.93 4.10% Meridian Hospitals Corporation $ 21,035.48 3.07% The Cooper Health System $ 20,255.26 2.96% Englewood Hospital And Medical Center $ 18,207.22 2.66% Hudson Hospital Opco Llc $ 14,387.72 2.10% St Josephs Hospital And Medical Center $ 13,364.00 1.95% Saint Barnabas Medical Center $ 13,266.58 1.94% ATLANTICARE REGIONAL MEDICAL CENTER $ 13,112.06 1.91% SOMERSET MEDICAL CENTER $ 10,517.04 1.54% Trinitas Regional Medical Center $ 7,253.56 1.06% South Jersey Hospital Inc $ 6,934.34 1.01%
Raw Data: Courtesy of Huron Consulting
Rank Specialty Invested Current Interest % Return
1 Orthopedic Surgery $51,458,363 $73,839,114 43.5% 2 Obstetrics & Gynecology $44,833,476 $42,701,714
3 Gastroenterology $44,407,718 $41,910,224
4 Cardiovascular Disease $36,413,038 $35,744,398
5 Ophthalmology $8,408,034 $31,160,069 270.6% 6 Surgery/Hospice and Palliative Medicine* $0 $21,733,719 Infinity 7 Neurological Surgery $13,353,588 $20,818,359 55.9% 8 Anesthesiology $4,057,986 $13,718,687 238.1% 9 Radiology/Diagnostic Radiology $2,068,745 $10,794,529 421.8% 10 Urology $6,196,856 $10,783,906 74.0% 11 Internal Medicine $4,490,437 $8,959,934 99.5%
* Represents 1 investor and one company
Last Name Initial Investment Current Value
Piskun $0 $21,733,719 Hensle $1,150,224 $4,208,291 Reiley $1,150,224 $4,098,921 Dello Russo $1,334,150 $1,332,500 Kindermann $144,000 $790,800 Parekh $450,000 $581,250 Lanteri $37,700 $576,179 PETROSINI $286,244 $367,906 HOLLAWELL $203,002 $289,815 GORMLEY $200,000 $200,000 DWYER $114,400 $114,400 Husserl $104,418 $104,418 ZANGER $103,392 $103,392 Piccoli $199,996 $102,562
Policy and Medicine 10/1/14
Rank Specialty Total Research Payments 1 Medical Oncology $5,121,943 2 Internal Medicine $3,389,810 3 Ophthalmology $3,247,256 4 Hematology & Oncology $3,180,196 5 Pediatric Hematology-Oncology $3,017,692 6 Pulmonary Disease $2,793,114 7 Other Service Providers/ Specialist $2,491,590 8 Radiation Oncology $2,391,436 9 Family Medicine $2,249,035 10 Rheumatology $1,362,191 11 Surgery $1,250,718
Teaching Hospital Payment Percent
Masked by CMS $698,014 45.9% Ahs Hospital Corp. $233,317 15.4% University of Medicine and Dentistry of NJ $171,322 11.3% The Cooper Health System $103,762 6.8% Saint Barnabas Medical Center $76,763 5.1% Meridian Hospitals Corporation $60,343 4.0% Deborah Heart And Lung Center $43,786 2.9% Saint Michael'S Medical Center $33,300 2.2% Centrastate Medical Center Inc. $23,412 1.5% Winthrop University Hospital Association $16,250 1.1% Englewood Hospital And Medical Center $13,900 0.9%
Open Payments 2013 Data – Policy and Medicine
2010 2011 2012 Difference 2011-2012 Difference 2010-2012 Total $64,572,273 $62,451,397 $55,615,073
Payments 17,162.00 16,443.00 19,549.00 16% 13.9% Average Payment $3,763 $4,265 $2,845
Median Payment $124 $147 $124
0.0%
2010 2011 2012 % Change 2011-2012 % Change 2010-2012 Total Payments $38,038,051 $35,106,567 $27,162,992
# of Payments 18,715 15,956 18,213 14%
Payment Size $2,032 $2,200 $1,491
Recipients 5,836 4,824 6,706 39% 15% Payment/Recipient $6,518 $7,277 $4,051
Compensation 58% Grants/Education 17% CME Conferences 9% Education/Training 4% Other 4% Food 3% Marketing Studies 3% Charatable Donantions 2%
2010 2011 2012 3 Years % Charitable Donation Total $2,949,818 $1,109,588 $1,447,269 ($1,502,549)
CMEs, third-party Conferences,
$7,647,238 $8,908,006 $5,085,729 ($2,561,509)
Compensation for Bona Fide Services Total $35,070,883 $32,627,559 $32,097,007 ($2,973,876)
Education/Training Total $2,516,437 $2,509,912 $2,170,666 ($345,771)
Food Total $1,181,526 $1,114,095 $1,556,465 $374,939 32% Grants/Educational Gifts Total $11,491,092 $11,717,624 $9,642,140 ($1,848,952)
Marketing Studies Total $1,222,770 $704,989 $1,507,442 $284,672 23% Other Total $2,345,808 $3,759,625 $2,059,638 ($286,170)
Grand Total $64,425,572 $62,451,397 $55,566,356 ($8,859,216)
Physicians 56% Accute Hospital 19% Clinical Labs 13% Clinic 5% Nurses 3% Pharmacists 2% Dentist 1% NP's 1% PA's 0% Podiatrists 0% Chiropractor 0% Optomitrists 0%
2010 2011 2012 Total $8,874,882 $8,692,011 $8,878,302 Average $177,497 $181,510 $177,566 Median $164,893 $152,926 $140,354 Change
2.10%
Of those listed four times in the top 50 – only 10 for all four years
1 Year 2 Years 3 Years 4 Years Physicians 59 25 17 10 Average/Year $135,746 $155,017 $154,346 $187,811
2010 2011 2010-2011 Difference 2012 2011-2012 Difference 2010-2012 Difference Total $16,715,739 $12,744,273
$5,218,848
Average $303,922 $245,082
$89,980
Median $14,290 $5,419
$5,729 6%
The Open Payments or “Sunshine Act” is designed to prey on the ancient physician prejudice that earning money is somehow beneath the profession, much like physician advertising was once taboo and frowned upon by the old guard. –Physicians Practice Magazine
Augusta Examiner
So Much For Transparency, Open Payments Database Toggles the Mind – The Wall Street Journal Another Government Website Rollout That Is Found Wanting – The New York Times Doctor Payments Show Little Value at Launch Time – US News Open Payments Site Launches to User Complaints – Health Leaders
As the inventor of a solution that preserves eye tissue for surgery, Bloomington’s Dr. Richard Lindstrom has given sight to legions of people worldwide and become highly sought after for speeches and consulting deals. He has been handsomely rewarded for his work. Lindstrom received $330,452 in payments just during the last five months of 2013 from companies whose ophthalmology products he prescribes for patients, according to a newly published federal database. (Minneapolis Star Tribune)
“…doctors reaping over half a million dollars each…” “…murky financial ties between physicians and the health care industry…” “…lucrative arrangements are just some of the findings…” “For some doctors, treating patients isn’t the only way to make money.” “A Michigan plastic surgeon was paid more than $300,000 to travel the world teaching doctors about new cosmetic products like a breast implant.” “The retired chief executive of the Mayo Clinic, who once helped write its conflict of interest policy, received more than $237,000 in compensation for serving on multiple corporate boards.”
– Anti kickback – False claims – Stark II – Consumer protection
– Malpractice and product liability suits – Qui Tam – Divorce and business – Consumer protection suits
Centers
This past year, physicians saw that improper payments were paired next to their names.
doctors with similar first and last names.
They de-identified at least one-third of the system’s data because of potential accuracy issues.
physicians this past year indicated the process was very time consuming and had some technical glitches.
non CME activities (Consulting, IRB, Non Accredited)
For Speakers, Consultants and Researchers
– Make sure agreements comply with applicable anti- kickback statues – Compensation needs to reflect fair market value for services delivered
company hiring you – including, meals, all forms of transportation, and lodging
industry
central office to ensure accuracy
– do the hard work for faculty
surprises
Database (Cleveland Clinic)
data, CMS has reportedly improved its technical
likely be posted.
to understand to be honest. Focus on why working with industry is important:
– Practicing surgeons are a vital source of information for companies and are also essential for training other surgeons going forward – Innovative devices and therapies stem from collaboration
products industry is required to be reported by numerous
– National Institutes of Health (NIH) – Food and Drug Administration (FDA) – Universities – Hospitals – Accredited Education – Medical Journals – Institutional Review Boards – Associations
West Virginia, Connecticut, D.C.
Sunshine language; dozens of European member companies have adopted disclosure provisions
– http://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment- Transparency-Program/index.html
– http://www.policymed.com/physician-payment-sunshine-act/
– www.ama-assn.org/go/sunshine
– http://www.healthydialogues.org/health-care-professionals
– http://advamed.org/issues/16/physician-payments-sunshine-law
– http://cmecoalition.org/resources
– http://www.medscape.org/viewarticle/780900 – http://www.medscape.org/viewarticle/807771
TamDevelopments
Enforcement Trends
Agreements
Act
Letters
and Enforcement
Compliance
www.Lifescicompliance.com
Thomas Sullivan
tsullivan@rockpointe.com 202-309-3507 www.policymed.com www.rockpointe.com