Check back - these will be updated over the week prior to the exam.
My exams have two objectives: 1) to force you into reading the materials and thinking about them so that you will learn the core of the course; and 2) to rank you so that I can assign grades. The first is the most important to me, the second is how I get there. As you can see from the sample exam from adlaw, there is one section of the exam that requires you to know the names of the cases that were assigned (not the cases cited inside the major cases) and their basic facts. (You do not need to be perfect in remembering the case name - if you are close and the answer is not ambiguous, you will get credit.) The purpose is to encourage you to study the cases, not because I think the case names have some special value, although I have chosen cases that you will use if you practice in this area. The remainder of the exam will be fairly short answers about legal principles and important background issues. I would make sure I have read the cases, focusing on the issues that were brought out in the class discussion or lecture, and I would go through my slides.
Remember, the exam is closed book, just like the bar exam.
There is nothing in the films that is on the exam that was not also discussed in class or covered in other materials.
Focus on Berkovitz by Berkovitz v. U.S., 486 U.S. 531 (1988) and Gregor v. Argenot Great Central Insurance Co., 851 So.2d 959 (La. 2003). Do not worry about the guest lectures. Figure out what discretionary authority means, when sovereign immunity is waived, and the limits on recovery from the state.
In the Pegram case, focus on the issues that affect medical malpractice litigation and how the court resolves these with the mixed decisionmaking model. Figure out what you need to know to sort out whether a plan is engaged in mixed decisionmaking.
What is a covered entity?
When do you need a business associate agreement?
What is a business associate contract?
What is PHI?
What is de-identified PHI?
When do you need authorization?
What are the individual's rights?
What are the exceptions to right of the patient to see his/her own records?
Can the health care provider release information to the health department without the patient's authorization?
Can the health care provider release information to law enforcement (such as child abuse reporting) without the patient's authorization?
Can the hospital disclose records to their lawyer without an authorization?
The 7 core elements and 3 statements necessary in an authorization to release PHI:
a description of the information to be used or disclosed,
the identification of the persons or class of persons authorized to make the use or disclosure of the protected health information,
the identification of the persons or class of persons to whom the covered entity is authorized to make the use or disclosure,
a description of each purpose of the use or disclosure,
an expiration date or event, (Final Rule allows "none" to be used in authorizations for any research study, as long as the authorization includes a statement that the authorization will have no expiration date)
the individual's signature and date, and
if signed by a personal representative, a description of his or her authority to act for the individual.
An authorization that does not contain all of the core elements does not meet the requirements for a valid authorization.
a statement that the individual may revoke the authorization in writing, and either a statement regarding the right to revoke, and instructions on how to exercise such right or, to the extent this information is included in the covered entity's notice, a reference to the notice,
a statement that treatment, payment, enrollment, or eligibility for benefits may not be conditioned on obtaining the authorization if such conditioning is prohibited by the Privacy Rule or, if conditioning is permitted, a statement about the consequences of refusing to sign the authorization, and
a statement about the potential for the protected health information to be redisclosed by the recipient. Although the notification statements are not included in the paragraph on core elements an authorization is not valid unless it contains both the required core elements, and all of the required statements.
What are the statutory caps in the medical malpractice act (MMA)?
What do you need to do if you want to file a medical malpractice case?
Who does the MMA cover?
What does a health care provider need to do to come under the MMA?
How do the medical review panels work?
What is their effect on litigation?
How are future medical costs handled under the MMA and PCF?
What is the PCF and are its weaknesses?
What are the constitutional objections that have been raised against the MMA and how did the courts resolve them?
> #1. In our notes we have 2 different places where we talked
> about drug trial phases, that are somewhat contradictory and
> need some clarifying. In one spot, we have Phase I that the
> drug is ok to be tested on humans and Phase II we have no
> notes, and Phase III is to see if the drug actually treats
> the people's ds. In the other place in our notes, we have
> Phase I is to find out the appropriate dosages and the side
> effects it causes, and for Phase II we have info about
> compassionate IND's and that it is given to sik people to see
> if it does any good for their ds, for Phase III we have no notes.
This is the first time a new drug is given to people at all. You do this after animal testing. You are looking for unexpected reactions and trying to figure out the starting dose, i.e., how much can you give someone before the drug makes them sick? If it is a dangerous drug, like a cancer drug, you use dying patients for Phase I.
Once you find out in Phase I that it does not kill people and what the basic dose is, you give it to a small number of people with the disease to see if works at all. Once you have data that it works, a doctor can ask for a compassionate IND to give the drug to a sick person who is not in the clinical trial. The drug company does not have to give the drug unless it wants to.
This is the large scale clinical trial where you test the drug against other treatments or a placebo to find out if it really works and what problems it may cause. If this is successful, you can then market the drug.
> #2. For ERISA, can the 3rd party administrator be in house?
Depends on what you mean by in-house. A third party administrator works for a company that is running the health plan for the company. The TPA might have an office in the workplace, but they must be representing some other company. If the company does it all itself it is a pure self-insured plan and has not TPA.
> Can you clarify what a 3rd party administrator is, we know it
> is covered if there is a 3rd party administrator, but what if
> the person doing all the negotiating is in house? Would it
> matter if they were on the plan's payroll?
> #3. Does ERISA apply to employers who self insure their
> employees and the employer bears the risk?
Yes, because the employees are considered part of the employer's business. Good question.
> #4. Is the following correct: Pregnant illegal women come
> from Mexico into the Valley and the hospitals have to take
> them b/c of EMTALA. This is b/c the hospital ER's are not
> allowed to screen them for US citizenship since it would be
> discrimination for a mon medical reason, then babies are
> born, and the babies are US citizens since they were born in the US.
Right. They do not the right to stay if that requires the mother to stay, but they have the right to return when they are older. This gets complicated because of the laws about not providing benefits to illegals, but you do not know they are illegal under EMTALA.
> #5. Under EMTALA, is it correct that if a MD does something
> to violate it, a pt only have a right of action against the
> hospital but the federal government can sanction the MD?
> this was my original question: "I have a question about the
> information you have on the study guide about HIPAA and MMA/PCF. Are the questions that you have on your website all that we need to study or do we need to have more of an extensive knowledge of these areas?"
And you told me that this was all we needed to know about these areas. My additional question about the MMA/PCF area is about the cases, Everett, Kelty and Patin- should we know these cases?? And what about the Zuckerman case in the HIPAA area?
As far as HIPAA and the PCF - stick to the questions, plus the additional material I have added to clarify some of the HIPAA stuff. Do not worry about Zuckerman. Everett, Kelty, and Patin have more in them than just the PCF and you should know them.
> We don't
> understand what advantages ERISA offers an employer who chooses a
> self-insured plan over a state regulated one.
You do not have to offer state mandated benefits, so your plan can be cheaper.
> specifically, when can a
> state regulate a plan that steps out of ERISA?
This is outside of the course, but the real question is when does a plan lose ERISA protection and thus become subject to state regulation. This is a complex issue and one that I just did a law review on, but I bet you do not want to know that bad.:-)
> What types of
> are they exempt from if ERISA applies?
Mandated benefits and some due process requirements when benefits are denied.
> If an ERISA plan steps out of
> federal preemption then what is the effect?
You just look like any other health plan and can be sued for state law negligence.
> If ERISA does
> apply when can a
> patient sue and for what COA?
That is the mixed decision problem that is discussed in Pegram - any time someone is making medical decisions, rather than pure contract decisions, then you can sue them for state law negligence if they screw up.
> Is there a fiduciary duty to
> the employees or
> is the fiduciary relationship always b/t the employer and the
The physician has a fiduciary duty to the patient, the plan has one to the benefits pools and the employees in general, but this is not something you need to worry about.
> Pegram, what type of decisions made by the doctor/owner of
> the plan could
> they have sued over...pure elegibility?
See mixed decision above and look at Pegram again - if it is a pure eligibility decision, then it is not a medical decision and ERISA preeempts tort claims - the only claims you need to think about.
> What are the limits on recovery from the state?
As far as I can tell, the same as against private health care providers.
> I am a little confused about informed consent. When analyzing informed consent, when we evalute what the patient should be told, should we use a reasonable patient standard or the community standard(physician standard). I have in my notes that most states and Louisiana use the community standard, is that correct? So does the standard really depend on what state you are in? Is reasonable person and reasonable patient standard the same thing and does it matter which one we use?????
The standard for what you tell patients for informed consent depends on the state, but I think you have it backwards - LA and most states use the reasonable person/patient (same thing). Check Lugenbuhl.
> Also under informed consent, from my understanding we use the above standard- community or reasonable patient(reasonable person) standard depending on the state, I am assuming, to establish the duty that the doctor has i.e. what he is to tell the patient. And then the expert or the common knowledge rule is used to establish whether there was a breach of this duty???
The reasonable person standard is used to decide what the patient should be told. The hard part to keep straight is that you have to have an expert to establish what the risks are, and that is a professional standard issue. For example, the patient has a heart attack after surgery. You need an expert to say that a heart attack is a complication of surgery, not just bad luck, then the jury decides if a reasonable person needs to be told about the heart attack. (Perhaps it was emergency surgery to save the patient's life and there was only a small chance of a heart attack.)
> And then we go on to analyze whether this breach caused the damage- and here we analyze whether if the doctor had told patient, they would or would have not forgone surgery. If they would have gone through with the surgery had they known then no causation, go to summary judgment. But if they would have forgone surgery had they known then causation is established and the jury allocates damages?
If the reasonable person would have had the surgery, then the patient loses, but it would probably be a jury verdict for the defendant because the jury and not the judge decides what the reasonable person would do. If a reasonable person would have skipped the surgery, then the jury can find for the plaintiff and assign damages based on the nature of the complication.
> Could you explain the "Borrowed Servant Doctrine"?
In the classic hospital context, it was when the nurse, who was employed by the hospital, was under the control of the physician, usually in the operating room. If the nurse was negligent while under the physician's direction, then the physician and not the hospital was liable.
> Can you please explain the Borrowed Servant Doctrine and the Captain
> of the Ship Doctrine in context with assertion of a defense? I think
> I understand how the hospital could assert the Borrowed Servant
> Doctrine but I am a little hazy with the Captain of the Ship. Perhaps
> I misunderstood what it stands for.??
Captain of the ship is a special case of borrowed servant, finding the surgeon in the operating room to be in charge of everyone, including, in some states, other physicians such as the anesthesiologist. It is pretty outmoded, but you still see it in some cases.
> 1st regarding Suing the state, what are the limits on
> recovery from the state?
$500,000 in med mal - say as against private providers
> 2nd If you know you have a medical malpractice claim...you
> file a claim with the PCF and the PCF gives notice to the
> MD's against whom the claim is filed. The MD's can then
> report the claim to their insurance companies. Where does the
> medical review panel come in? In my notes it says filing the
> claim with the medical review panel interrupts prescription?
> So is that the same thing as filing with the PCF?
Filing with the PCF triggers the medical review panel process, which is a necessary first step to filing a lawsuit, so it interrupts prescription. This is important because the panel process can be time consuming.
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