Health Law Flowcharts PDF

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Overview of all topics and concepts covered in Health Law and Policy class. Use to study for exam. ...

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INTRO 1. Three Tensions of Healthcare a. Right vs. commodity b. Professionalism vs. cost and quality control c. Individual freedom vs. public health and morals 2. Three themes/tensions of healthcare a. Have warped otherwise sensible areas of law b. These three commitments do a lot of work twisting law c. Law does not pass through world of healthcare unscathed 3. Schematic organization of class a. To pay for things we get in physician/patient relationship… b. We need access to healthcare/insurance (MCOs, ERISA, private hospitals, Medicare/Medicaid, ACA, etc.). c. But, access to healthcare is not the only thing that affects health – also public health concerns such as tobacco regulation and obesity. d. Finally, issues of bioethics, such as right to die, and civil commitment. 4. No single unifying theme of healthcare system a. So, no single, unifying theme of this class b. Know the issues, basic building blocks of understanding healthcare c. And we all participate in the market – so knowledge and understanding is essential RULES 5. Duty to treat at common law a. Hospital – shift to common carrier  must treat patients in unmistakable emergencies because of detrimental reliance (Manlove) b. Doctor – no duty to treat at all, even in an emergency, as long as there is no existing treatment relationship (Hurley v. Eddingfield) i. But, once a treatment relationship has formed duty to not abandon unless patient is given reasonable notice to find alternative treatment (Ricks v. Budge) ii. Doctor can incur a duty to treat through a pre-existing relationship with a hospital or HMO, via on-call agreement 6. Duty to treat –EMTALA a. Purpose – forcing common law duty to attach, creating treatment relationship to prevent patient abandonment b. EMTALA only applies to hospitals that accept federal government funding for Medicaid/Medicare programs c. Hospital i. Patient presents ii. Duty to (1) screen and (2) stabilize iii. Duty to screen: 1. Must be standard process (“appropriate” medical screening) for all patients – concern here about prejudice against specific patients (i.e., indigent patients) 2. EMTALA leaves to hospital to decide what “appropriate” medical screening is iv. Outcome of screening process: 1. If no EMC, you’ve completed EMTALA requirements

a. Must be made in good faith b. Can still be liable under STATE med mal if EMC exists 2. If emergency medical condition exists  stabilize a. Active labor included v. Duty to stabilize: 1. Moses (6th Cir.) – Stabilize = treating patient so they will not deteriorate upon discharge (contradicts statutory definition) 2. 4th and 9th Circuits and HHS – Stabilization is met if admitted in good faith (bad faith would be to admit the patient just to immediately discharge them) a. Disparate treatment for pregnant women and sick people 3. 11th and 1st Circuits – Stabilization = to make safe for discharge or transfer; if no discharge or transfer occurs, no EMTALA obligations (e.g., if patient is screened, EMC is discovered, but then patient dies, no liability – but can still have STATE med mal) d. Transfer – Cannot transfer unless stabilized i. Exceptions: 1. (1) Patients wants it 2. (2) Doctor determines benefits outweigh risks, fills out paperwork, other hosp accepts and has space e. Doctor – not liable under EMTALA, but can be fined as an administrative enforcement mechanism f. Note: Any time you drop out of EMTALA and tx relationship is formed, see common law (duty state med/mal & not abandon patient), Wickline and Wilson g. Note: Maybe sub. Medical outcome better 7. Informed Consent a. Culbertson (Slight Majority) – Reasonable physician standard (duty is what custom is); expert testimony is required to show this. b. Canterbury – Reasonable patient standard (duty is to tell a patient what a reasonable patient would want to know); this collapses into med mal standard. Pt has to prove he would have chosen something different. Causation problems. c. Note: there are exceptions to these standards i. Emergency situations/unconscious patient ii. Doctor reasonably believes that informing the patient would cause some harm to the patient (paternalistic) iii. Try and get consent from relative d. Discuss problems with informed consent 8. Profit vs. Non-profit a. To qualify as a non-profit must satisfy: i. (1) Charitable purpose: 1. Community benefit standard – providing medical care that benefits the community; no indigent inpatient care required, but must still provide emergency care regardless of ability to pay (Eastern Kentucky) (IRS 69’) 2. ER is not necessary if community does not need it 3. Specialized hospitals also exempt 4. But, some state pushback (see Utah County v. Intermountain) 5. ACA §9007 requires community needs assessment, financial assistance policy, policy for ER care, limits on charges (< = lowest insurance rate), no extraordinary billing

ii. (2) Non-distribution of earnings 1. Salaries should reflect market 2. No signing bonuses unless rural or urban b. Change: We should get the IRS to impose qualifications that make sense 9. Can you sue your MCO for interfering in provider care? (Not in ERISA World) a. Wickline – suggested that insurers can be held liable when appropriate, but ultimately put responsibility for treatment decisions on the doctor. In the absence of negligent medical care, you cannot sue either. i. Suggests that the doctor should pushback against the HMO b. Wilson – both doctor and HMO can be held liable i. Insurer responsibility - to not arbitrarily deny medically necessary care 1. In Wilson - state could only deny coverage when to do so was in accordance with the usual standards of medical practice ii. Doctor responsibility - to provide adequate care and not abandon the patient (See Common Law Duties) 1. Wilson – Doctor does not have to pushback, but that is what court suggested in Wickline 10. Courts pushing back against MCOs – Economic Credentialing a. Most courts follow Potvin dissent, i. except where MCO has substantial market dominance – then Potvin majority applies b. Does MCO (utilizing network restrictions) have a substantial dominance in a marketplace (MAJORITY VIEW)? i. If yes – Potvin majority applies – doctor has a common law right to fair procedure 1. Substantively rational a. Business judgment rule/rational basis 2. Procedurally fair a. Notice, hearing, opportunity to be heard, etc. ii. If no – Potvin dissent applies - right to K, doctor does not have a substantive right to compensation – looks like at-will employment c. MINORITY VIEW follows Potvin majority in all situations d. Note: What happens if we don’t let MCO’s control costs? 11. ERISA – Preemption of state tort claims (§502(a)) (Important because of remedy) a. Can only get appropriate equitable relief if ERISA preempts state tort claims b. (1) First question – is the employer self-insuring i. If no, not in ERISA land – have state remedies ii. If yes, continue on c. (2) Second question was there a denial of a benefit owed to you under the plan? i. If no, not in ERISA land – have state remedies ii. If yes, do Pegram/Davila analysis d. (3) Who made the decision (Pegram/Davila analysis)? i. Doctor = treatment decision, state remedies ii. MCO = eligibility/coverage decisions, ERISA e. Because of exclusivity, if you can bring an ERISA claim, all you have is an ERISA claim against MCO – and ERISA remedies are shit 12. ERISA – Preemption of state regulation (§514)

a. Whether a state regulation applies to an entity (is it preempted or not?) – use this analysis: b. (1) Does the state regulation “relate to” an employee benefit plan? (Broad preemption of state regulations of employee benefit plans) i. Does it change the plan or does it influence the plan? 1. Change – If the state is giving entity no choice, e.g., the state is mandating that employers either provide a benefit or do something else, regulation is preempted (Fielder)  in ERISA land  go to #2 a. See also, Delta – New York mandated particular provisions (maternity) – was preempted 2. Influence – Even direct economic influence is okay, provided there is a choice (Golden Gate)  NOT in ERISA land  STOP ANALYSIS (STATE REG IS GOOD) a. See also, BCBS – direct economic influence making BCBS cheaper insurance than private was influence, thus not preempted c. (2) Is the law a regulation of insurance? (Gives states back insurance regulation) i. Kentucky Association of Health Plans v. Miller Test: 1. Specifically directed towards those businesses and entities engaged in insurance 2. Substantially affect risk pooling arrangement between insurer and insured ii. If yes, move back into state regulation land (savings clause), and go to #3 iii. If no  stay in ERISA land, STOP ANALYSIS d. (3) Is it directed at a self-insured plan? i. If yes  deemed NOT insurance, and is preempted by ERISA ii. If no  stay in state regulation land, regulation is not preempted by ERISA 13. Modifying Medicaid Provider Rates - §30(a) a. States are trying to modify Medicaid reimbursement rates because their budgets are bursting b. 9Cir: Procedural Requirements, before making changes (State Burden) i. Before changing rates, states are required to show their changes bear reasonable relationship to hospitals costs via responsible cost studies (Orthopedic Hospital v. Belshe) c. 7Cir: Substantive Requirements, after making change (Challenger Burden) i. State was not required under equal access provision to conduct comprehensive study before implementing new rules. Challenger must show changes resulted in unavailability of care and service. (Methodist Hospital Inc. v. Sullivan) d. Bagley: 7Cir will prevail, will determine how much latitude states have to address payments (overall budget concern).These lawsuits decide the way forward 14. Constitutionality of the Mandate a. Must do three things if you want expanded access to healthcare through insurance, 1 of these things is to prevent adverse selection, and the individual mandate is the only way to do so b. Arguments against constitutionality: i. Not an economic activity ii. Commandeering of the people (U.S. v. Printz, U.S. v. New York) iii. Tax and spending power doesn’t apply c. Arguments for constitutionality:

i. Stevens Approach: Not purchasing healthcare is an economic activity, thus an enumerated power of Congress and is constitutional ii. Scalia Approach: This is not necessarily economic activity, but the individual mandate is necessary and proper to the overall commercial regulation of the insurance market, thus is constitutional (see Wickard) 15. Tobacco Regulation/Obesity a. Central Hudson Test for Prohibitions: i. The speech concerns lawful activity and is not misleading (we generally assume this – otherwise rest of analysis is not necessary) ii. Government must have a substantial interest iii. The regulation must directly advance the Government interest 1. Does not have to be the best means available iv. Is it appropriately narrowly tailored to accomplish its goals b. Compelled Speech i. Rational basis test c. Rule of thumb: If the regulation restricts or prohibits truthful speech, it will usually be deemed unconstitutional i. Eliminating important channels will also probably fail test d. Regulations forcing disclosure of truthful information is likely constitutional 16. Civil Commitment a. What do you have to show to civilly commit someone (Addington v. Texas)? i. Parens patriae – mental illness 1. Idea of helping those who cannot help themselves ii. Police power – dangerousness to others 1. Future threat to society b. Shift – Kansas v. Hendricks i. Mental abnormality 1. Relaxing of mental illness requirement seen in Addington – court/legislature defines terms, not medical profession ii. Dangerousness to others iii. Raw exercise of police power 17. Note: Problems w/ doctor power, evid. Standard doesn’t matter v. Right to Die 18. Personal autonomy a. Cruzan v. Director, Missouri Department of Health (1990) i. The Court did not find a substantive due process right to refuse life-sustaining treatment. However, it is now settled law that such a right exists. ii. Held: Clear and convincing evidence standard is an acceptable evidentiary standard to determine whether a person may refuse life-sustaining treatment. It is up to state discretion whether they want to use preponderance or clear and convincing standard. 1. But, Missouri legislature is really putting their thumb on the scale here by mandating a higher evidentiary burden b. Washington v. Glucksberg (1997) i. Physician assisted suicide ii. 14A substantive due process claim iii. There is a substantive due process right to choose how you die, but physician assisted suicide is not a part of that right

iv. Held: The right to assisted suicide is not a fundamental liberty interest protected by SDP since its practice has been offensive to our national traditions and the ban was rationally related to the states legitimate interest in protecting medical ethics, preventing euthanasia, shielding the disabled, and preservation of human life. c. Vacco v. Quill i. Employing a rationality test for the EPC, Court held that New York’s ban was rationally related to the state’s interest in protecting medical ethics, preventing euthanasia, shielding the disabled, and preservation of human life. ii. Court distinguished between the refusal of life saving treatment and assisted suicide, by noting that the latter involves the criminal elements of causation and intent 19. Fraud a. Anti-kickback Statutes i. Explicitly prohibits “kickbacks, bribes or rebates” in connection with services for which payment could be made under Medicare ii. All that needs to be shown to establish a violation is that someone gave the doctor money, including fee-splitting, with the expectation of referrals (but this is a hollow obligation – when you pay a doctor a salary, you expect referrals) (Greber) iii. Criminalizes a lot of status quo health system behavior iv. Congress authorized HHS to issue safe harbors for transaction deemed to be not harmful – exceptions to sanctions b. Stark Bill i. Prohibition on self-referrals ii. Doctor or family prohibited from having financial interest of any kind in referral destination 1. E.g., can’t have ownership interest, investment interest, compensation interest iii. Full of exceptions 1. E.g., group practices, in-office ancillary services, used to be exception for physician owned hospitals but ACA gets rid of this one c. False Claims Act (Think Medicare/Medicaid) i. Provider knowingly or recklessly submits false claim to the government ii. Penalty can be astronomical iii. Government principle, but also third parties can sue (qui tam, relators) iv. Use when doctors have billed for procedures not medically indicated...