Conflicts of Interest

Teaching procedures on the recently deceased Tracheal intubation, central venous catheter insertion pericardiocentesis, urethral catheterization - should consent be obtained from family members to perform these procedures?

(No answer given)

Question 6: Are there religious issues that might influence clinical decisions and create COI?

(Review)

Question 7: What are the legal issues that might affect clinical decisions and create COI?

(Review)

A 53 year old man with a 3 year history of diabetes and family history of heart disease is found to have 2 vessel disease on stress test. Medical therapy initially helps and then recurs. The patient wants a referral to a cardiologist but the PCP denies the request because his practice closely monitors his referral patterns for expensive care like interventional cardiology.

(Skipped)

An internist decides to start a "concierge" practice where she will limit her patients to 500 and will charge them $1,000 per year to have unlimited access to her outpatient services. They will still maintain insurance to pay for non-physician fees (labs, x-rays, PT, etc.). Her patients who can't afford this are asked to find another provider. The limited number of patients (500, whereas currently she has 4200 charts) will allow her to spend more time with her family yet not see a financial decrease. Is this unethical of this physician?

(Skipped)

Question 8: Are there considerations of clinical research and education that affect clinical decisions?

"Off-label" use of drugs to treat conditions beyond those for which the drug was approved. "Investigational treatment" - therapy that is still under development but trials are not concluded. "Compassionate use" - the physician and the sponsor of a new drug may petition the FDA to use the drug for a patient with an immediately life-threatening disease.

A 30-year-old male is diagnosed pre-symptomatically with Huntington Disease (autosomal dominant). His testing was prompted since his father was recently diagnosed. The man requests that his wife of four months not be informed of the diagnosis. The wife is also a patient of yours, and you know that she has gone off birth control due to desire to have children. How do you handle the conflict?

(He skipped it in lecture)

Question 5: Are there problems of allocation of scarce health resources that might affect clinical decisions and create COI? Example: ICU beds are all taken in a hospital. A 78-year-old man comes to the ER in an ambulance due to SOB. He has known CAD, COPD, and diabetes. He has no family and has not completed an advance directive. In the past, when he has had to be intubated, it was several weeks before he could be weaned off. Should the providers intubate at this time? If so, where will he go since ICU is full?

(Lecture Ended Here)

A 35-year-old male is in CHF due to failure of his prosthetic heart valve from infection. He is an active drug abuser and did not stop using after his first valve replacement. Should he receive the second valve replacement?

(No Answer Given)

A healthy 18yo on birth control pills presents with new onset light flashes and "black spots" in both eyes. No other symptoms. Likely diagnosis is "ocular migraine" Order an MRI? The risk of a brain tumor is less than 1% but missing a brain tumor now could lead to enlargement. A healthy 35yo woman presents with iritis (inflammation in the eyes). The chances of a $1000 blood workup revealing the underlying cause of here iritis is 3%. Order the blood work? Assume that ongoing systemic damage could be occurring in that 3%.

(No answer given)

A resident has two admissions from the ER to take care of. A patient with a 5-cm scalp laceration comes in to the ER. A student has been on the ER service for only two days. Should the resident sew up the patient himself, let the student do the repair under his supervision, or take care of the admissions while the student sews up the patient?

(No answer given)

An elderly woman admitted to a teaching hospital states she doesn't want "anybody practicing on me." She is on antibiotic therapy that requires blood to be drawn at peak and trough times. The resident is tied up in an emergency situation, and it is time to draw blood. How do you handle the patient's request yet take care of the lab order?

(No answer given)

As a general rule, can a covered entity use or disclose PHI? What are the 4 permitted disclosures?

*A COVERED ENTITY AND BUSINESS ASSOCIATE CANNOT USE OR DISCLOSE PHI* EXCEPT AS PERMITTED BY HIPAA OR AS REQUESTED BY AN INDIVIDUAL Permitted Disclosures: 1. to the individual themselves or their HIPAA designees 2. for treatment, payment and health care operations (TPH) 3. With authorization 4. For the public interest

What is the Tarasoff Liability? Review: In *October 1969*, Prosenjit Poddar murdered Tatiana Tarasoff (Tarasoff). Plaintiffs, Tatiana's parents, contended that only a short time prior, Poddar had expressed his intention to do so. This, they alleged, he had confided to his therapist, Dr. Lawrence Moore, a psychologist employed by University of California.

*A defendant owes a duty of care to all persons who are foreseeably endangered by his conduct*, with respect to all risks that make the conduct unreasonably dangerous. When the avoidance of foreseeable harm requires a defendant to control the conduct of another person, or to warn of such conduct, *liability is imposed only if the defendant bears some special relationship to the dangerous person or to the potential victim*.

What is the Anti-Kickback Statute? What is Stark Law?

*Anti-Kickback Statute*: Criminal liability for an individual or entity that "knowingly and willfully solicits, receives, offers or pays any remuneration (including any kickback, bribe, or rebate)" in "return for" or "to induce" referrals or services (business) reimbursable by the federal government. *Stark Law*: Prevents entities and individuals from making referrals to entities in which they have a "financial relationship" (defined as "an ownership or investment interest" or "compensation arrangement").

What was the result of Greenberg v. Miami (2003)? Greenberg solicited the help of research scientist Dr. Matalon to cure Canavan's disease Tissue samples provided to Dr. Matalon Dr. Matalon discovers the Canavan gene Unknown to the patients, Dr. Matalon receives a patent on the genetic sequence and sells it for others to use in research *ISSUE*: Did the researcher have a fiduciary duty to disclose his economic interest to his clients?

*NO* "The allegations are clearly distinguishable (from Moore) because here the defendant (Dr. Matalon) was solely a medical researcher and there was no therapeutic relationship as in Moore."

*HYA!* In Accoutable Care Organizations (ACOs) what is... - Productivity-based compensation: - Straight salary: - Incentive-based Compensation: - Capitation:

*Productivity-based compensation*: Physician income based on percentage of either billing or collections. *Straight salary*: Set income negotiated at time of hiring and renegotiated at set intervals. May include a bonus/incentive program. *Incentive-based compensation*: A portion of physician income is based on measurable performance around their ACO goals and benchmarks. *Capitation*: Physician income based on a pre-established percentage of the total revenue from system payers (private and public).

Question 2: Are there parties other than clinicians and patients, such as families of patients, who have a legitimate interest in clinical decisions that can create to COI? If so, what are they?

*Surrogates* (alternate medical decision-makers when the patient is unable to do so) may have interests that conflict with the patient's wishes. Example: A 78-year-old rancher with three sons is found to have resectable lung cancer. Due to breathing difficulty, he is currently intubated. His oldest son, who is durable power of attorney for healthcare, decides his father is too weak for the surgery. The bronchial obstruction causing the SOB is life-threatening. - The surrogate my have their own interests above the patient's. This puts the doctor in the tough spot. - They doctor may want to take the case to court. Example: An 80 year old man has severe osteoarthritis and congestive heart failure. He requires constant care and assistance with ambulation. His primary caregiver is his 82 year old wife, who is in reasonable health but has severe asthma. She is finding herself unable to give her husband the care he requires and encourages him to consider assisted living. He refuses. - Didn't say much about this, just who do you listen to?

A 27 year old man is diagnosed HIV positive. He tells the physician that he cannot face the prospect of his partner learning about the infection. Does VA allow disclosure to the patients' partner?

*Virginia law allows disclosure of HIV status to the patient's spouse/partner*. *Notification of public health authorities is a duty of all physicians caring for an HIV positive patient*, and is required by Virginia law. Similar laws are in place for Hepatitis B/C.

What was the results of Moore v. Regents (1990)? Moore had hairy cell leukemia treated by Dr. Golde Moore had surgery and seven years of follow-up Spleen and cells retained for research without Moore's consent Golde receives substantial royalties *ISSUE*: Under the duty to obtain informed consent, must the doctor disclose his intent in using a patient for research and economic gain?

*YES* An adult has the right to exercise control over his own body Consent to treatment must be informed consent "A physician has a fiduciary duty to disclose all information material to a patient's decision" and "a physician's failure to disclose...is a breach of that fiduciary duty." Note the dual role of Golde as physician and researcher

What was the result of Grimes v. Kennedy Krieger (2001)? Johns Hopkins, the EPA and the State of Maryland joined up in a research projects Lead abatement: allowed children to live in housing with certain levels of lead to see how much was too much Received "informed consent" Hopkins argues they owe no duty to the children because they are researchers not physicians *ISSUE*: Can informed consent in nontherapeutic research constitute a special relationship giving rise to a duty to the subject?

*YES* There is a special relationship created between researchers and their human subjects...determined on a case by case basis. The Greenberg court rejected the plaintiff (Greenberg's) use of Grimes saying Grimes was "human experimentation" and Greenberg was "medical research"

Privilege, Privacy, and Confidentiality: When does a breach of confidentiality occur? What is the duty of confidentiality? What is the difference between "privacy" and "confidentiality"? What is privileged information?

A *breach of confidentiality occurs when a patient's private information is disclosed to a third party without his or her consent*. The *professional duty of confidentiality* covers not only *what a patient may reveal to the doctor, but also any opinions and conclusions that the doctor may form after having examined the patient*. It covers all medical records, as well as communications between the doctor and patient. This includes other staff in the office. "Privacy" is frequently used interchangeably with "confidentiality" but is differentiated in the legal sense. There is a Fourth Amendment right to privacy and a recognized "right to privacy" that is considered a fundamental right under the Due Process clauses of the Constitution. *Privileged information* is that which may not be compelled to disclosure because of the sanctity of the relationship as recognized by government. Examples include: doctor-patient, attorney-client, Pastor-parishioner, psychologist- client

What is a conflict of values?

A gynecologist is on the staff of the only hospital within 100 miles. The physician does not support abortion, but the hospital allows them to be performed by other clinicians. This creates a *conflict of values* for the clinician.

What is a conflict of obligation?

A surgeon is asked to be Chief of Staff at his hospital - an obligation of 10-15 hours of time a week. This will reduce both his ability to see patients in his office, as well as his income due to reduced volume in surgery. This creates a *conflict of obligation* for the surgeon.

An Accountable Care Organization (ACO) rewards clinicians over and above their salary if they don't order high-cost interventions/diagnostic studies that are not supported by evidence-based guidelines. Do these clinicians have a conflict of interest?

Consider the CHF patient. You now have an incentive to give the patient some diuretics and Calcium channel blockers instead of referring them to a cardiologist for expensive tests. This presents a conflict of interest for the physician. - It is a huge dilemma in they physician community - They want value over volume

What was the result of Bragdon v Abbot (Supreme Court, 1998) Can a physician refuse or alter care of an HIV-positive patient without violating the equal treatment stipulations of the Americans with Disabilities Act of 1990 (ADA)?

During a visit to her dentist's office, in order to fill a cavity, Sidney Abbott disclosed that although she did not manifest any obvious symptoms she carried the human immunodeficiency virus (HIV). When her dentist, Randon Bragdon, refused to treat her in his office, offering to conduct any necessary work at a hospital for no extra charge other than use of the facilities, Abbott challenged his policy as discriminatory. After both a federal trial and *an appeals court ruled in Abbott's favor, Bragdon appealed and the Supreme Court granted certiorari*. *The answer to the question is no.* In a 5-to-4 opinion, the Court held that although the ADA does not force care-givers to treat an "individual [who] poses a direct threat to the health or safety of others," it also prohibits discrimination against any individual "on the basis of disability in the enjoyment of the services of any place of public accommodation by any person who operates [such] a place." The Court then reasoned that since HIV "substantially limits" major life activities, such as reproduction, the infection is a "disability" that entitles its victims to ADA protections. Having said this, however, the Court concluded that only care-givers can determine if treating an HIV-positive individual would constitute a "direct threat" to themselves or others. Therefore, the Court remanded for further risk assessment based on objective medical evidence or risk.

We will be going through "Ten questions to consider when analyzing and ethical issue." They will be denoted as "Question X: ___" at the top of each slide. We'll start with 1... Question 1: Are there professional, interprofessional, personal, or business interests that might create conflicts of interest in clinical treatment of patients? What are two examples of this?

Example: An obstetrician who purchases an ultrasound machine for his office orders 20% more ultrasounds than he did when patients were sent to the hospital for this test. - This could be legitimate, but can be scene as a conflict Example: An infectious disease specialist is exposed to Ebola when caring for patients in the hospital. She feels her family's safety is threatened by her work. Can she refuse to care for certain patient populations? - Legal answer is no

Question 4: Are there financial factors that create conflicts of interest in clinical decisions? Example?

Example: Should physicians limit how many Medicare/Medicaid patients are accepted into the practice since reimbursement may be lower? "Concierge Medicine" - *It is legal to do* - It may not be very moral though

What is the two step analysis for HIPAA analysis?

FIRST: What type of health data is it? TWO: What type of entity is it?

What is de-identified information? What is personal health informatioN?

IS THE DATA HEALTH INFORMATION IDENTIFABLE TO AN INDIVIDUAL (IIHI)? If no, then it is *"DE-IDENTIFIED"* health information (the HIPAA regulation outline how to successfully de-identify data) and HIPAA does not apply. If the data is IIHI then unless it being used for some specific purposes it is considered *PHI (PERSONAL HEALTH INFORMATION)*

What questions can determine the type of entity in HIPAA Privacy Analysis?

IS THE DATA MANAGED BY A "COVERED ENTITY" (CE) (HEALTH CARE PLAN, HEALTH CARE PROVIDER)? IS THE ENTITY A "BUSINESS ASSOCIATE" (BA) OF THE COVERED ENTITY?

Example: A nurse overhears a specialist telling another physician that he is not going to do a cardiology consult until the next day so he can attend his daughter's high school play in which she has a part. The nurse is concerned about the shortness of breath the patient has been demonstrating. Is this a conflict of interest for the doctor and/or the nurse?

Nurse has a conflict. She has to decide whether she will report him or not. He doesn't really answer the Doctor's problem. He says that the Doctor could get someone else to do it. This is more a question or morals, not legality. The patient could be in CHF. This is all he really says about it...

Question 10: Are there conflicts of interest within institutions and organizations that may affect clinical decisions and patient welfare?

Occupational health - keeping an employee off work vs. reducing employer lost-time costs. Medicare patients being discharged from the hospital earlier than in the past.

Question 9: Are there issues of public health and safety that affect clinical decisions?

Parents refusing to immunize their children - are you ethical in removing them from a pediatric practice? A patient with MRSA needs to be admitted to a long-term care facility - can you refuse admission? Clinician exposure to communicable diseases

What was the result of the Bradshaw v Daniel (1993) case? Elmer Johns was admitted into the hospital and diagnosed with Rocky Mountain Spotted Fever. Dr. Daniels treated him, and Johns later died. Dr. Daniels never warned Johns' wife, Genevieve of the risk of catching the disease. Later on Genevieve caught the disease and suffered the same fate as her husband. Bradshaw, the decedents' son, filed suit against Dr. Daniels for negligence for failure to warn.

The *court held that the physician had a duty to warn his patient's wife of the risk to her of contracting Rocky Mountain Spotted Fever*, when he knew, or in the exercise of reasonable care, should have known, that his patient was suffering from the disease.

Review this announcement of when the Justice Department Reached a Settlement on HIV.

The Justice Department announced today (2013) that, as part of its Barrier-Free Care Initiative , it has *reached a settlement with Woodlawn Family Dentistry, of Alexandria, Va., under the Americans with Disabilities Act (ADA)*. This is the *third settlement addressing HIV discrimination by a medical provider reached by the Justice Department in three weeks*. The Justice Department *found that Woodlawn Family Dentistry required a patient with HIV to schedule all future appointments as the last appointment of the day*. The department determined that, *because the patient has HIV, Woodlawn failed to offer him the same options and availability in scheduling future appointments as it offered to other people*. The department further determined that *there was no lawful reason why Woodlawn could not treat the patient at any time during normal business hours*. "Ensuring that people with HIV are treated equally and with dignity is critical, especially in the medical field," said Thomas E. Perez, Assistant Attorney General for the Civil Rights Division. "The ADA does not tolerate this type of discrimination and neither will the Justice Department." Under the settlement, *Woodlawn must pay $7,000 to the patient and $3,000 in civil penalties*. In addition, *Woodlawn must train its staff on the ADA and develop and implement an anti-discrimination policy*.

What are the two aspects of HIPAA analysis?

The Right to Confidentiality/Privacy of your medical information is codified in Federal Law under the Health Insurance Portability and Accountability Act (HIPAA) of 1996. There are also state medical privilege, confidentiality and privacy law that must be complied with. 1) *PRIVACY REGULATIONS* - what is private? 2) *SECURITY REGULATIONS* - how must the data be protected?

What is a conflict of interest?

The potential exists when an independent observer would question whether a *clinician's/researcher's professional actions/decisions are unduly influenced by considerations of significant personal interest*.

Four family medicine physicians decide to open a small clinical laboratory in town that could provide services to the other eight physicians in town. Currently, patients have to drive 30 miles to the hospital, or have their blood drawn and picked up by courier at night. Is this a conflict of interest?

Yes! The physicians have to watch out for referrals to an entity that they own! (See Stark and AKS on next card)

Example: A 75-year-old Japanese woman comes to the US to live with her grandson. When she is diagnosed with cancer, her grandson said, "We do not want her to be told this diagnosis, but we want her to have full treatment." Her current type of cancer has a 5% chance of cure even with treatment. Is there a conflict of interest for the oncologist?

You need to decide who you have a duty to, and it is to your patient! So the physician is presented with a conflict of interest here.