Conflicts of Interest and the Modern Physician

1
Conflicts of Interest and the Modern Physician

• Thomas R. McLean, MD, JD, FACS, Esq.
• Medical Director, Third Millennium Consultants,
  LLC
• Clinical Assistant Professor of Surgery, KU
  School of Medicine

2
The Age of Enlightenment

• During the Inquisition decision making was based
  on emotion
• Many found such decision making to be arbitrary
  and capricious

3
The Age of Enlightenment

• Solution mathematical logic became the standard
  to judge reasonableness
• Scientific and medical processes became
  reproducible predictable

4
Medical School

• The modern medical school is perhaps the summit
  of achievement for the Age of Enlightenment
• Each year the cumulative knowledge of 250 years
  of prospective randomized double blinded
  studies are imparted to eager medical students
• So, why after leaving medical school do
  physicians not apply the science?

5
Case Study

• Dr. Crawford was world renowned for aortic
  surgery
• Of necessity complex aortic surgery is associated
  with a significant blood transfusion requirement

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Case Study

• Science dictates that patients who undergo
  complex aortic surgery should have a significant
  incidence of Hepatitis
• Dr. Crawford stated -in public- that his
  patient population did not have an excessive
  incidence of Hepatitis
• Fact Dr. Crawfords patients did have a
  significant incidence of Hepatitis

7
Case Study

• So, why did Dr. Crawford deny what everyone knew?
• Dr. Crawford was a partner in a blood washing
  enterprise
• That is, Dr. Crawford had a conflict of interest

8
Case Study

• Was Dr. Crawford bad or evil because of his
  conflict of interest?
• Yes, if he is judged by the logical application
  of science
• Because his conflict of interest corrupted his
  decision-making process

9
Case Study

• All that Dr. Crawford wanted,
• all that most physicians really want, is for
  his children to go to Harvard
• But, Dr. Crawford did have a classic conflict of
  interest

10
Case Study

• To under stand the practice of Medicine one has
  to realize that logic only take you so far
• You must also factor in emotional needs

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Conflicts of Interest

• Arise where logical reason intersects with
  emotional feelings
• We are taught algorithms for solving such
  dilemmas at an early age

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Conflicts of Interest

• How do Conflicts of Interest affect medical
  management?
• The emotional component how are you going to pay
  for your childs Harvard education is easy to
  understand
• Accordingly, we must review the logic and
  alternatives for managing coronary artery disease

13
CABG

• Indications are based on 3 classic studies from
  the 1970s CASS, EUROCASS the VA COOPERATIVE
  STUDY
• All 3 were prospective, randomized controlled
• Exclusion LMCA disease

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CABG

• Findings of all 3 studies
• 1-vessel disease gt95 5-year survival regardless
  of treatment, but 10 of the subjects crossed
  over to the surgery group
• NB The excellent 5-year survival was achieved
  with the medication present in the 1970s Inderal
  / NTG

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CABG

• 3-vessel disease Medically treated patients had
  a survival of only 60-70 and 40 of such
  patients crossed over to surgery
• Surgical patients has a significantly better
  5-year survival compared to medically treated
  patients
• However, surgery patients were not returned to
  age-matched survival

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CABG

• Achilles Heel
• SVG durability 50 of grafts are occluded at 5
  years
• Translation At 10 years about 10 of surgical
  patients will undergo a redo-CABG

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CABG

• Indications for surgical intervention in the
  treatment of CAD
• 1. LMCA Disease
• 2. 3-vessel Disease EF gt30
• 3. Failure of medical management

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CABG

• Recall that all three prospective randomized
  studies demonstrated that there was a significant
  5-year survival advantage for patients with
  3-vessel disease
• If the patient population in these studies was
  composed of predominately middle-aged white
  males, then at what point does the survival
  advantage vanish

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CABG

• Series 1 represents mortality for patients
  undergoing CABG in their 80s
• Series 2 represents risk matched controls in
  their 50s
• At what point do we stop offering CABG?

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CABG

• Charles R Bridges, Fred H Edwards, Eric D
  Peterson, Laura P Coombs, and T Bruce Ferguson,
  Cardiac Surgery in Nonagenarians and
  Centenarians, J Am Coll Surg 197347-356
  (2003)(with careful patient selection, a
  majority of these patients have a lower risk of
  CABG-related mortality approaching that of
  younger patients).

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CABG

• In the UK patients are not dialyzed after age 65
• Why does the US not cut its medical expenditures
  by refusing to pay for bypass surgery after some
  year
• Is it because lobbing by the AARP or
• the AMA / Society of Thoracic Surgeons?

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CABG

• Personal Opinion
• America would be better off investing in rain
  forest research, rather than attempting to make
  Grandmothers immortal
• Otherwise, there may not be Grandmothers

23
Medical Economics

• gt600,000 CABG are performed per year
• This is the highest rate per capita of
  revascularization in the World
• How did this happen?
• NYT 3/20/04

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Medical Economics

• If the year is 1950, and you are a Thoracic
  Surgeon, what kind of practice do you have so as
  to send your children to Harvard?
• Specialized in treating the complication of
  empyema and TB

25
Medical Economics

• The introduction of Penicillin and Streptomycin
  changed Thoracic surgery forever
• The Heart which had been not operable because it
  moved, became operable

26
Medical Economics

• Was it because of Gibbons innovative pump
  oxygenator?
• Possibly. More probabilistic was the principle
  that necessity is the mother of invention
• Here, the necessity for the Thoracic Surgeons was
  sending their children to Harvard

27
Medical Economics

• Once again business was good as there was a
  surplus of value and congenital disease
• But, only a finite number of congenital cases
  exist at a given time
• No problem value disease is ubiquitous due to RHD

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Where have all the valve cases gone?
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Medical Economics

• Hence in the late 60s nomadic Thoracic
  Surgeons need a new home
• CAD which accounted for gt 400,000 deaths per year
  was irresistible

30
Medical Economics

• Soon innovations in surgery, e.g. Cardioplegia,
  made Bypass Surgery less demanding
• This allowed DeBakey to introduce Fords Assemble
  Line techniques

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Medical Economics

• FFS made for some very rich Cardiac Surgeons
• One even purchased a professional football team
• Lots of case material, lots of money, no
  problems right?

32
Medical Economics

• Recall that Cardiologist are human and want their
  children to go to Harvard
• FFS reward service, the bigger the service, the
  bigger the pay check

33
Medical Economics

• PTCA was introduced in 1983
• But was it a better mousetrap?

34
PTCA

• Problem This Better mousetrap was and continues
  to be applied to single vessel disease
• Recall that single vessel disease has a 5 year
  survival of gt95, and only 10 of patients
  required intervention over the next 5 years and
  that this was achieved with the limited medical
  regiment of the 1970s

35
PTCA

• ACME Trial PTCA v. Medical Therapy
• Success rate 80
• 64 PTCA pts v. 46 med. tx were free of angina
• PTCA pts were able to exercise at higher work
  loads
• NB notice that P-values were not provided

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PTCA

• ACME Trial Results
• 9 of medical treated patients crossed over to
  PTCA this was predicable based on the
  information in the surgery literature
• 2 PTCA pts required emergent CABG
• 1 PTCA pts sustained a Q-wave infarction

37
PTCA

• Multivessel disease
• Recurrence of symptoms over 3-6 months follow-up
  is high 50
• Generally consider to be less than ideal
  treatment for the general patient with
  multivessel disease
• NB Recurrence rates (for single and multiple
  vessel agents have improved with newer adjective
  agents a topic beyond the scope of this lecture.

38
PTCA

• EAST Trial Comparison of multivessel PTCA v.
  Surgery
• Excluded
• 1. one or more total occlusions,
• 2. LMCA disease,
• 3. EF lt 25
• Only 15 of screened pts were randomized

39
PTCA

• EAST Trial Results
• Only 15 were deemed appropriate of angioplasty
  contrasts with clinical practice
• Results in less highly selected patients has lead
  to the clinical impression that routine
  angioplasty, without more, for multivessel
  disease is less efficacious than CABG.

40
PTCA

• Results have been improved with routine use of
  Antiglycoprotein IIa\IIIb
• But it is controversial whether this additional
  therapy would still not make PTCA equivalent to
  surgery for Multi-vessel disease.

41
PTCA

• Limitation to angioplasty secondary intervention
• Key question who pays for the secondary
  intervention?
• The insurers have known for 10 years that once a
  patient undergoes PTCA, they can expect several
  more bills over the next 5-years

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Athrectomy

• Approved by the FDA in 1990
• Essentially same results as angioplasty
• However, some stenosis care better treated with
  one of these techniques. (e.g.CAVEAT II SVG
  results.)
• A surgeon view PTCA and Athrectomy are different
  clubs in the cardiologists golf bag

43
Stenting

• FDA approved 1993
• Is this a better mousetrap?
• STRESS Trial PTCA PTCA w/ stent
• 1 year actuarial incidence of symptom-driven
  repeat intervention of the target lesion was
  lower in the stent group 22 v 14 NB no P
  value

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Stenting

• Are Stents a better mouse trap?
• The next generation of stents Coated Stents
• Coated-Stent Studies Lead the Pack of Trials
  presented at ACC02 Cardiology 311 (2002)
• First in Man Trial using Sirolimus
• 45 patients with no recurrences at 2-years
• Lord Action warned that those who do not know
  history are doomed to repeated it Sound advice
  for Thoracic Surgeons

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Stenting

• 5-year results for Drug Eluding Stenting in
  Multivessel disease
• No difference in survival or freedom from
  infaction
• Although pts treated with stents needed more
  episodes o f repeat revascularization
• AE Rodriguez et al, Argentine Randomized Trial,
  J. Am. Coll. Card. 2005 46582-8
• PW Serruys et al., ARTS Randomized Trial, J. Am.
  Coll. Card. 2005 46575-81
• J. Aoki et al., Insights from Arts, Eur. Heart J.
  2005 261488-93

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Epilogue

• Conflict of Interest 1069 addition fee to
  cardiologist for first stent Medicare allowable,
  1999

47
Epilogue

• The corruption of physicians because of conflicts
  of interest is not new.
• Science allows the doctor to see what does not
  exist even if what does exist would be obvious
  to an idiot.

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M O N E Y
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Understanding Money

• Means understanding some basic principles of
  accounting
• Principle 1, tax accounting uses a unique set
  of rules
• Tax law make some individual behave in unexpected
  ways

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Accounting

• Generally Accepted Accounting Principles
• Rules of Accounting which serve as a standard to
  judge the reasonableness of an accountants
  discretion
• Analogous to medicines rules based on
  prospective randomized studies

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CPT coding

• Current Procedural Terminology
• Promulgated annually by the AMA
• Codifies all services provide by physicians
• Example Code 33513 is the CPT code for a single
  IMA CABG, while Code 33717 codes for an
  additional two vein graphs
• Problem up coding without more

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E/M Guidelines

• Are the documentation requirements a physician
  must provided to Federal Governments if the
  physician wishes to be reimbursed
• Hence E/M Guidelines are a form of government
  imposed GAAP
• Will make the prosecution of false claims both
  civil and criminal much easier
• We will discuss failure to comply with required
  documentation during the next lecture

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Medicare Allowable

• The maximum dollar value a physician may collect
  for a medical service provided to a Medicare
  Beneficiary
• Payment is determined by the CPT code used.

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Medicare Allowable

• Pop quiz Does a physician actually receive the
  full Medicare allowable dollar value?
• Answer No

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Medicare Allowable

• A physician is only entitled to receive by law
  80 of the Medicare allowable figure from the
  federal government any amount contractually
  required by a secondary insurer
• All Medicare Providers contractually agree not to
  attempt to collect any unpaid portion of the bill
  from a Medicare Beneficiary

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Medicare Allowable

• What if a Medicare Beneficiary does not have any
  secondary insurance?
• 20 of the Medicare Allowable fee is not
  recoverable
• So why does the Medicare Beneficiary even need
  secondary insurance?
• Some necessities e.g. prescriptions are not
  covered by Medicare

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MD income

• In 2001, the Medicare Allowable reimbursement of
  a 3-vessel CABG one IMA was approximately
  2100.00
• Assume a surgeon has a practice of only Medicare
  Beneficiaries, none of whom have purchased
  secondary insurance
• Assume this surgeon performs 100 3-vessel CABGs
  per year

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MD income

• Then, the theoretic maximum gross income the
  surgeon could collect is 210,000.00
• But since Medicare will only allow 80 of this
  figure, the actual gross income the surgeon
  receives is 170,000
• But, remember gross income is not take home income

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MD income

• Take home income requires a few more steps
• Actual Gross Income 170,000
• less 35 overhead 100,000
• less 35 personal tax 67,000

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Bottom Line MD income

• This hypothetical surgeon will take home 67,000
• Not a bad income certainly above the mean income
  of all Americans

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MD income During the Golden Age of
Fee-For-Service

• It will be instructive for us if we consider our
  same hypothetical surgeon performing the same
  work load in the 1970
• FFS reimbursement, in general, meant that what
  one billed for one received
• During the 1970s, 5500.00 was not an unusual fee
  for a 3-vessel CABG

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MD income During the Golden Age of
Fee-For-Service

• Theoretic Gross Income 550,000
• Assume 80 TGI is collectable 440,000
• less 35 overhead 286,000
• less 35 personal tax 185,900

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MD Income Instant Replay

• A surgeons take home pay during the Golden Age
  185,000.00 is approximately the same as a
• Present day surgeons theoretical maximum income
  210,000.00
• Can you see why so much time and effort is spent
  discussing MDs income?

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MD income

• MDs income have probably hit bottom if MD income
  goes any lower, what would be the incentive to
  complete residency?
• Good News and Bad News
• Government is preparing to end payment by DRGs /
  RBRVS
• Bad News not all physicians are going to have
  patients
• Question Are medical societies your friend?
• Same Motivation?
• Wait to you hear some of the AMAs ideas to get
  rich quick.

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Final Question

• Are medical societies your friend?
• Same Motivation?
• Wait to you hear some of the AMAs ideas to get
  rich quick (next lecture).

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Conclusions

• No sets out to be a physicians with conflicts of
  interest
• but, as you contemplate your childs
  matriculation into Harvard, remember the classics
  

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Resolving Conflicts of Interest