Health Law

Sermchief v. Gonzalez

-F: Nurses operating pursuant to standing orders. Board of Med threatens nurses with action for unauthorized practice of med and physicians with action for aiding and abetting unauthorized practice of med - H: Nurses were being supervised by physicians, so couldn't be practicing medicine; Nurses' acts were authorized under the Nurse Practice Act and therefore within their SOP (expanding role of nursing) and operating pursuant to standing orders - Rule: to the extent that NPs are being supervised by physicians, they can't be practicing medicine (i) In TN, have to have a physician come by every 30 days to review portion of the charts

Defenses to a Med-Mal Suit: "Respectable Minority)

SOC Exception -aka "two schools of thought doctrine" - physician acted in accordance with an accepted practice, but used by a minority of physicians

What is IC?

- AMA says it is more than getting a pt to sign a written consent form. Process between pt and physician that involves disclosure and discussion of (i) Pt's dx if known (ii) Nature and purpose of a proposed tx or procedure (iii) Risks and benefits of a proposed tx or procedure (iv) Alternatives- risk/ benefits (v) Risks and benefits of foregoing

Medicaid Managed Care

- Essentially "Medicaid Advantage" - controlled by 3P insurers; require Section 1115 waivers to operate in this way a. Only have appeal rights set forth through the insurance company, as opposed to the established process for Medicaid pts b. TN is 100% managed care -State takes whatever chunk of money it receives from the fed govt plus whatever the state budgeted for and turns it over to these managed care companies a. If the state gives insurers more money than they have to pay out in claims get to keep the money b. If the insurers pay out more for claims than what the state gave eat that loss

Corporate Negligence: Darling v. Charleston Community Memorial Hosp

- F: 18 y/o's leg had to be amputated after application of cast severely impaired circulation resulting in gangrene of the LE -H: Physician was definitely negligent but claim against hosp was independent of that physician's negligence--> hosp negligent in failure to provide sufficient number of adequately trained nurses and failure to require a consult

Medicaid Administration and Enforcement Against a State--> Medicaid Appeal Rights

- Medicaid is considered an entitlement program, not just a contract between state and federal govt -Westside Mothers v. Havemen--> establishing that beneficiaries have right to bring federal Section 1983 claims for certain portions of the Medicaid Act under the Blessing Test (limited to specific payment provision and not policy statements) -1. Armstrong v. Exceptional Child Center --> individuals/ providers can't bring actions against states for violations of the Medicaid Act (like low rates leading to inadequate network) under the Supremacy Clause- process for that is through the APA (Administrative process?)

Practice Guidelines as the SOC

- Minority- can use Practice Guidelines to fully set out the SOC - Majority (Including TN)- expert witnesses may rely on clinical practice guidelines if the conduct prescribed by those guidelines describes the specific actions that would be taken by a minimally competed physician--> you can present practice Guidelines as evidence of the the SOC but it has to be one thing presented by an expert witness (can't use the Guidelines as an independent source for setting a SOC) (Conn v. US- MI case) (i) A danger of Practice Guidelines is that there is no way to "cross examine" the guidelines (ii) Practice Guidelines in GA- adopted statute codifying the rules from Conn and the one used in TN

Coverage Gap

- NFIB v. Sebelius- determined that Medicaid expansion was essentially a new program and federal govt could not require states to expand - In non-expansion states, don't qualify for subsidies unless 100% of the FPL, so if below that then can't get subsidy and not covered by expansion

Premium Assistance Tax Credit: how it's adjusted/ works

- NOT adjusted based on rising premiums; the percentage is constant for that year. (i) It is all worked out through taxes at the end of the year--> when you sign up, if you make $20,000 you're going to get subsidies based on that. if you get a job that pays $50,000 during that year, then you will owe in taxes what you should have been paying based on that pay increase

Comparative Negligence

- New Rule - Allows for reduction to the P's award based on percentage of fault · Some jurs permit recovery only if P was not more at fault than D, comparatively

Entering into exclusive contracts: Clean Sweep Provisions

- Often in exclusive contracts with physician groups; provides that termination of the contract will result automatically in termination of staff privileges without benefit of the procedures in the medical staff bylaws (i) Basically the providers are waiving the rights they would be afforded if they just had privileges in an open system (ii) Means that they could be fired if hosp decides to let the group go and don't get to go through hearing process in the medical staff by-laws

Blessing Test

- Once determine that the case can proceed under Ex parte Young, apply Blessing Test to determine whether there is a privately enforceable right against state officers · Statutory section was intended to benefit the putative P--> intended for these Ps · Sets a binding obligation on a govt unit, rather than merely expressing a Cong preference--> binding obligation because if Michigan is participating in Medicaid, then they are bound by the rules · Interests the P asserts are not so vague and amorphous that their Enforcement would strain judicial competence--> interests not vague or amorphous

Medicare Part D: Doughnut Hole

- Originally covered drugs up to $3700 and then would not kick back in until $8000+ · ACA attempting to plug 25% co-insurance for all drugs after 2020

Doctrine of Avoidable Consequences

- P can't recover for any portion of the harm that could have been avoided by the exercise of ordinary care · "Rule of damages" and NOT a defense that would bar a claim · Ostrowski- pt could have damages reduced based on post-procedure behavior that led to eventual amputation from gangrene, but couldn't have damages award completely taken away based on contributory/ comparative negligence

When Physicians can be found liable by DHHS under EMTALA

- Physicians can be found personally liable under EMTALA (i) If physician fails to respond when assigned as the on-call physician (ii) If certification for transfer is knowingly false (iii) If physician is working in specialty hospital

Corporate Negligence: Washington v. Washington Hosp. Center

-F: Claim WHC was negligent in failing to provide anesthesiologists with an end-tidal CO2 monitor - H: P's expert plus other evidence allowed a reasonable juror to fairly conclude that monitors were required as part of a national standard of care * Resource based caveat didn't really apply here because there was documentation that the hosp was aware that CO2 monitors were national SOC and were supposed to acquire the CO2 monitors prior to P's sx

Invasion of Privacy/ Breach of Confidentiality: Doe v. Medlantic HC Group

-F: Co-worker that also worked at hosp allegedly searched medical records and found that P had AIDS. Shared with co-workers. P sued HC facility -H: finding breach of confidential relationship against the hosp D based on violation of Hosp's own policies and procedures (1) Proving actual breach of protocol was not necessary. It was enough to have people testify that no one really followed hosp protocols, hosp didn't enforce the protocols, and P put up enough evidence to make that the logical conclusion

"Direct Threat"- Bragdon v. Abbott

-F: Dentist refused to fill pt's cavity outside the hosp setting because pt was HIV positive. Pt brought ADA suit (i) To show direct threat, Bragdon had to show why hospital (using objective scientific evidence) posed less of a threat to his safety (ii) H: remand to lower court to ensure that evidence court relied on were adequate to support a finding in favor of pt (on remand, court found in favor of pt)

Invasion of Privacy/ Breach of Confidentiality: Humphers v. First Interstate Bank of Oregon

-F: Dr. helped adopted child access hospital medical records to find her birth mother. Birth mother sued - H: Not an invasion of privacy because Dr. did not pry into a confidence, he failed to keep one--> Breach of Confidentiality · If doctor had still been alive could have reported him to Medical Board -Duty is "outside" the tort claim. Can be found in: (1) Legal obligation by a physician to report child abuse and certain diseases (2) Laws that disqualify physicians from licensure or discipline physicians for divulging a professional secret (3) Laws regarding privilege of info in hearing (FRE)

Defense to Duty of Care: Shorter v. Drury

-F: Jehovah's witness signed a release from liability for refusing blood transfusion prior to D and C. Dr. lacerated uterus and she bled to death. Jury found Dr. negligent but that decedent assumed the risk - H: Affirmed: Refusal is valid--> Pt accepted the consequences of refusing blood, but did not waive a negligently performed procedure. Assumption of the risk is a defense

Apparent Agency: Burless v. WV Univ. Hosps. Inc.

-F: Med mal suit from women who delivered at hosp and babies had permanent defects. Both signed disclaimers that they understood the faculty physicians and resident physicians were not hosp employees --> denied MSJ by hosp (i) Question of fact as to element 1: doctors there and disclaimer insufficient How are pts supposed to distinguish between "faculty physicians" and "resident physicians" from other physicians (ii) Question of fact as to element 2- both Ps provided evidence that they believed the physicians treating them were hosp employees

MedMal defenses/ damages limitations: Contributory Fault

Ostrowski v. Azzara -Prior to the injury (most courts won't allow pt's pre-tx conduct to limit liability) (1) Doctrine of the particularly susceptible victim (2) Contributory negligence (3) comparative negligence (4) assumption fo the risk - After the Injury (1) Doctrine of avoidable consequences (2) Doctrine of aggravation of a pre-existing injury

Continuing Duty of Care

Ricks v. Budge - After undertaking a case (establishing a pt-physician relationship), unless there is an agreement limiting the service, there is a duty of continuing attention so long as the case requires it - Duty of Continuing Attention can be terminated by (termination of obligation to tx) (i) The condition no longer requires attention (ii) The pt fires the physician (iii) The physician withdraws AND provides reasonable notice so as to enable the pt to secure other medical attention · TN requires written notification to the pt and at least 30 days to find a new physician. If pt can't find a new physician then can't withdraw from pt's care

Defenses to a Med-Mal Suit: Procedural Innovation

SOC Exception (i) Medical experimentation- a physician txs his pt in conformity with a protocol crafted to test an hypothesis and to add to the body of medical knowledge; isn't for the benefit of that pt, rather it's for the benefit of the public in general (ii) Medical practice- assumes accepted therapies designed solely to enhance the well-being of an individual pt and that have a reasonable expectation of success (iii) Procedural Innovation- falls somewhere between the two: typically an unproved approach used on a limited number of pts to benefit that particular pt · Basically, sometimes doctors have to make game time decisions · Does not require an IRB

Defenses to a Med-Mal Suit: "Battle of the Experts"

SOC Exception -most powerful defense is that physician acted in accordance with the prevailing medical SOC --experts battle to establish what the prevailing SOC actually is

When considering anti-discrimination, consider all options

common law, EMTALA, ADA, FRA, Title VI, and ADEA

3 Pillars of health

cost quality access

Who does HIPAA apply to?

covered entities and business associates

Alternative Payment Models (APMs)

in this if you're already operating in an alternative pt demo project (ACOs, medical homes, etc) and don't have to join MIPS

An ACO's shared savings is impacted by...

its compliance with 33 quality measures

Reimbursement Limitation: Wickline v. State

-F: Medi-Cal used prospective cost containment program (pre-auth); determined that pt did not need to stay in hospital as long as requested and pt had post-op complication at home that required amputating her leg - H: Medi-Cal not liable because findings of Medi-Cal did not override the medical judgment of the physicians who had the ultimate responsibility regarding her care and tx (1) Physicians should have appealed the Medi-Cal decision · Medi-Cal and programs like it are in a tight spot because have an obligation to the people it covers to make sure they get care they need, but also have a responsibility to the State to be good stewards of those funds

Corporate Negligence: Thompson v. Nason Hospital

-Test for Corp. Negligence - F: Thompson involved in car accident and taken to Nason Hosp. Informed medical staff that she was on Coumadin. Switched to heparin and exhibited neuro symptoms and bleeding (bleeding into her eye and hematuria), but no one consulted neuro. - H: Sufficient question of material fact as to whether Nason was negligent in supervising care, so that trial court could not grant MSJ on issue of corporate liability

Title VI of the Civil Rights Act, FRA, ADA all involve...

motive

Remedy for winning a LCD decision in court

reconsideration

SOC set by Courts

some courts find that the standard is so lacking, courts must impose one

IC: Negligence Action- Injury Causation

the consented-to tx caused the injury

EMTALA applies to

to all hosp that (1) participate in Medicare and (2) have an ED

Effects of NCD

· One shot- if you have a device and see if CMS will cover it, if CMS says no, then you're done--> you can't try to get it through again but CMS can decide on its own to change its mind · If CMS makes decision that something is covered then coverage will apply to all MACs · If CMS denies a NCD, then MAC can NO LONGER cover that--> NCD trumps LCDs on all levels (but doesn't apply retrospectively)

Medicare Part A does not cover

· Private-duty nursing · Private room (unless medically necessary) · TV and phone in your room · Personal care items, like razors and slipper socks

Part A may be provided at no cost if:

· You receive or are eligible for social security benefits · You receive or are eligible to receive RR retirement benefits · Your spouse (living or deceased, including divorced) receives or is eligible to revie either of the above · You or your spouse worked in a govt job through which you paid Medicare taxes · You are the dependent parent of a fully insured deceased child

Can a PCP participate in multiple ACOs? Can a beneficiary?

A PCP can participate in more than one ACO, although a beneficiary will only be assigned to one ACO

Exception to SOC (either locality or national)

- adherence to acceptable practice is not a defense if the physician fails to use his best judgment (Burton v. Brooklyn Doctors Hospital) · Physician using minority theory but was part of research that concluded the majority theory was better

Medical Error

- failure of planned action to be completed as intended or the use of a wrong plan to achieve an aim - A specific person has done something wrong--> implies negligence

SOC: National Standard (Majority)

- physician expected to possess such medical knowledge as is commonly possessed and reasonably available to minimally competent physicians in the same specialty or general field of practice throughout the US. -"Duty to have practical working knowledge of the facilities, equipment, resources, and options reasonably available to him as well as the practical limitations of such" · Resource-based caveat- physician's duty of care is limited by available resources: specialized facilities and equipment (Hall v. Hilbun- ex-lap case that established a new SOC--> national SOC with a resource based caveat)

SOC: Locality Rule (minority)

-"based on generally recognized and accepted practices for physicians in the community" -physician expected to possess such medical knowledge as is commonly possessed and reasonably available to minimally competent physicians in the same specialty or general field of practice in the community

What should physicians do if their pt's insurance won't cover something

-"recommend a less expensive but still effective tx" (1) Generic drugs (2) Lower cost alternatives in advance (x-ray prior to MRI) (3) Alternative non-sx tx

HIPAA: Breach Analysis

-Analysis to go through if you think you might have a HIPAA breach, and thus, might need to give notice · Nature and extent of PHI involved- what was actually in the info? (names, birth dates, SS number, how much, etc) · Unauthorized person to whom the disclosure was made · Whether the PHI was actually acquired or viewed · The extent to which the risk to PHI has been mitigated- did I immediately call the clinic to say I sent the info in error?

IC: Negligence Action- Duty of Disclosure

A. Reasonable Pt Standard (Canterbury) · Must be disclosed if it is material to a reasonable pt's decision (1) A risk is material if a reasonable person in the pt's situation would likely attach significance to the risk in deciding whether to undergo the procedure B. Reasonable Practitioner (community standard) · IC is proven based on expert testimony about what the standard of IC is for like physicians in the community

Defining Illness Case

Kastkee v. Blue Cross Blue Shield of Nebraska - I: whether a condition that makes someone more likely to dev CA is an "illness" under the policy -H: suffered from a bodily disorder or disease and, thus, suffered from an illness as defined by the insurance policy - Disease/ disorder- her condition was a DEVIATION FROM WHAT IS CONSIDERED NORMAL (definition of illness), healthy physical state caused by an abnormal genetic constitution, which when combined with her fam hx, significantly increased her risk of CA a. "we are wary that not every condition which itself constitutes a predisposition to another illness is necessarily an illness within the meaning of an insurance policy" --> qualifying and limiting

Why license HC pro?

Licensure is a form of quality control in HC by creating rules and structure regarding who can enter the market and who can hold themselves out to the public as a provider of services

IC: Negligence Action- Causation

Need Decision Causation AND Injury Causation: IC can only be sustained as "the cause" of the alleged injury, if: adequate disclosure could reasonably be expected to have caused that person to decline the tx because of the revelation of the kind of risk or danger that resulted in harm

Are covered entities required to provide a paper copy of its Notice of Privacy practice?

No but must offer to let each pt see a paper copy and have pt sign a form acknowledging this offer

Standard of Review for Individuals Licensed within the Profession isn't met where:

The Board supplants its view for the Hearing Officer's without substantial evidence (i) In re Williams (ii) Hoover v. The Agency for HC Admin

IC: Johnson v. Kokemoor

Woman had aneurysm in spine and physician had never done this type of procedure. He represented to her that he had done dozens of similar surgeries--> negligent

IC: Truman v. Thomas

Woman refused Pap smears d/t cost against doctor's recommendation but doctor never informed her of the risk of refusal--> doctor guilty of negligence

Rebuttable presumption of IC if...

signed IC form (in most jur)

ACO: 2-Sided Risk Model

- ACO has both "upside" and "downside" risk (1) ACO is required to share in the losses, but may receive up to 60% of savings to the extent achieved (2) Savings is offset also by percentage of compliance with the 33 quality metrics

Who pays for HC

-Commercial (private) insurance -govt insurance -out-of-pocket (self-pay; aka uninsured)

Medicare Part B

-Covers Doctor's office visits (out-pt stuff) and physician's portion of in-pt stuff -premiums required on sliding scale

Medicare Part A covers

-Covers hospital-related services and emergency care (in-pt stuff) -Also has hospice and a little bit of nursing home coverage; inpt- rehab facilities, LTC hosp - no premiums for vast majority

Affirmative Defenses to Med-Mal suit

-Do not relate to the underlying negligence or merits of the claim, but are a legal mechanism for dismissing the case (1) Statute of Limitations (2) Good Samaritan

Elements of Medical Malpractice suit

-Duty of Care -SOC (i) National Standard of Care OR (ii) Locality Rule -Breach of SOC -P was damaged by such breach (injury and causation)- most frequent challenges to causation are pre-existing condition and joint tort-feasors

Implied Agency

-Hosp has exhibited sufficient control such that this person is agent, even if not contractually (also Burless)

Invasion of Privacy- 4 types of claims

Common Law- four kinds of claims grouped under the "privacy" tort (i) Appropriation of the P's name or likeness (ii) Unreasonable and offensive intrusion on the seclusion of another (iii) Public disclosure of private facts (iv) Publicity that places the P in a false light in the public eye

Reimbursement Limitation: Wilson v. Blue Cross of Southern California

Court found physician to be jointly liable with insurer for death of pt when he was discharged because of lack of coverage

Medicaid Expansion

Covers ALL individuals aged 19-64 with modified adjusted gross income of 138% (133% plus a 5% income disregard) of the poverty line

Good Samaritan

D is immune from civil liability for any damages caused if D renders emergency aid. Sometimes extends to professionals in the emergency rooms of hospitals if you're having to cover something that isn't in your specialty (think more rural hosp)

Expert Medical Witnesses

(i) Medical Malpractice experts base their testimony on knowledge, education, and experience (ii) Medical expert witnesses do NOT have to practice in the same community, but must familiarize himself with the facilities, resources, services, and (iii) Daubert changed evidentiary standard for scientific testimony- up to the trial judge to assess the reliability of the expert's testimony and whether it is based on scientifically valid principles (as opposed to generally accepted practices)--> imposes a higher standard on the med mal expert (won't suffice to say that we know there is all this material saying A is the best, but here, we do B) · Moving to that national standard of care and away from the locality rule

HIPAa: Business Assocaites

(1) Members of a Covered Entities' workforce are not considered Business Associates (2) An entity/ individual can be both a Covered Entity and a Business Associate (3) Business Associates are directly liable for violations of the HIPPA Privacy and Security Rules -When a Business Associate makes a breach of unsecured PHI it is required to notify the Covered Entity and may be responsible for payment of notification. Regs do not say which of these is responsible for paying for and providing notification to the pt

Bylaws as Contract?

(i) Minority of jurs consider the Hosp Bylaws (which governs medical staff membership) to be a contract, which gives physicians the ability to sue over hosp not following bylaws under a breach of contract claim (ii) JCo standards require that the medical staff approve any amendments to the bylaws

violations for not complying with Medicare/ Medicaid standards are usually...

(i) Monetary in nature (ii) CMS and surveyors hesitant to pull certification because of lack of providers to perform these services

Medicare Coverage Determinations: National Coverage Determinations (NCDs)

(i) Requests that go directly to CMS and affect Medicare as a whole · Requests can come by external party for new NCD, external party for reconsideration of existing NCD, aggrieved party to issue an NCD, or CMS for new NCD or reconsideration (ii) If beneficiary is in need of covered service and NCD is being reviewed, final decision must be made in 90 days

Med Mal Defenses

(i) SOC Exceptions · Followed SOC (battle of the experts) · "2 schools of thought" or "respectable minority" (ii) Clinical innovation · Procedural innovation · Off-label use (iii) Affirmative Defenses · Statute of limitations · Good Samaritan Acts (iv) Contributory fault of patient (including comparative negligence) (v) Causation (vi) Adjustment of Damages · "loss of chance" doctrine · Punitive damages

HIPAA Preemption

(i) States can enact laws that are stricter than HIPAA but CAN'T pass laws that lower the floor below HIPAA (ii) If it is "contrary to" then HIPAA preempts state law (contrary to means you can't comply with both the state law and HIPAA at the same time) (iii) Byrne v. Avery Center- a private right of action under state law is not preempted by the fact that HIPAA does not offer a private right of action this is not contrary to HIPAA

SOC and Expert Medical Witnesses in TN

(i) TN has Contiguous State Rule (T.C.A. § 26-29-115)- Can only have expert witness that is licensed to practice in the state or a contiguous state, unless, it is not possible to find an expert within the contiguous region that can testify (we use a national standard of care) · Fear is that jury is just going to go with the person that works at the Mayo Clinic or has the more impressive pedigree

Bundled Payments

- 50yr pilot program where payments are "bundled" in Medicare to cover payments to the physicians, hosp, and post-acute facility to encourage integration and coordination - CMS and providers set a target payment and are paid by Medicare on a discounted fee-for-service payment and then the amt is reconciled with the target price b. Providers (hosp and physicians or hosp and post-acute providers) are paid a "bundled" or "grouped" rate that pays for the whole episode of care, encouraging the providers to work together; NO quality metrics

General Rule Regarding Privacy

- "a covered entity or business associate may not use or disclose protected health info, except as permitted or required by the privacy rule" · Required disclosure to: (1) Individual (2) Secretary of HHS · Permitted disclosure without notice: (1) To the individual (2) For tx, payment, or HC operations (physician re-credentialing is considered part of HC operations) (3) Incident to a use or disclosure otherwise permitted (4) Unless otherwise prohibited, pursuant to a valid authorization (5) Pursuant to an agreement to allow the individual to object (6) As permitted under other regulations · Permitted with notice (164.508) (1) All info not specifically permitted without authorization under the rules without a valid authorization (2) Psychotherapy notes (subject to exceptions for tx, payment, or operations, or a required disclosure) (3) Marketing (4) Sale of PHI

Reducing Civil Monetary Penalty (CMP) for nursing home violating Medicare/ Medicaid standards

- ACA modified CMP sanctions a. Self- reporting- if facility reports within 10 days of discovery (prior to survey), fine can be cut by up to 50%

IC: Duty of Disclosure- What if a pt does not want to know or refuses to follow advice?

(i) A physician has an obligation to inform the pt not only regarding the inherent risks of a tx, but also of the risks of not undergoing a tx or dx (Truman)

HIPAA: What info is protected by the privacy rule

(i) All specific info that could directly ID a person (18 in total) (ii) Can share info if totally de-ID a person (iii) Minimum Necessary Rule- When making a permitted disclosure may only share the minimum necessary info from the medical record to comply with the request

Economic Credentialing and Conflicts of Interest

(i) Economic credentialing- when a hosp makes credentialing decisions based on financial considerations as opposed to quality (ii) No HCQIA Immunity (usually) (iii) Murphy v. Baptist Health- Hosp adopted Conflict of Interest Policy- Physician who owns a direct or indirect ownership or investment interest in a competing hosp is ineligible for staff privileges · H: Policy unconscionable and illegal To the extent a provision prevents pts from seeing a physician that the pt wants to see, can't do it (1) However, as a hosp employee, hosp can say you can't work at another hosp (but this is a different kind of relationship)

ACO Risk Models

(i) Effectively a garnishing program--> claims for beneficiaries last year will be compared to claims for beneficiaries this year (ii) An ACO may choose in the beginning to be in one of two "tracks" for the first 3 years, which impacts the financial risk taken by the ACO (a) One-Sided Risk Model (b) Two-Sided Risk Model

Defenses to a Med-Mal Suit: Off-label Uses

(i) FDA reviews and approves all drugs for a specific purpose (ii) Off label use- circ in which a doctor prescribes a drug or uses a device in a manner that varies in some way from the drug's or device's FDA-approved labeling (iii) It is illegal for drug co to promote drug for off-label use but it is NOT illegal for doctor to rx a drug for an off-label use (iv) Drug label does NOT establish the SOC--> the fact that a drug has been used off-label and against packaging info can be used as evidence, but can't establish SOC

What is HIPAA

(i) Generally protects a person's PHI (ii) Violations can result in penalties and fines but NO private right of action · Report violation to the Office of Civil Rights of the Dept. of Health and Human Services (OCR) (iii) Serves as a floor and not a ceiling, and so long as a state statute is not contrary to HIPAA, the state statute can stand (and must be followed)

Reimbursement Limitation

(i) Injury caused not by medical negligence, but by decision-making driven by reimbursement (Wickline) (ii) Managed care controls over tx · Pre-auth requirements for certain procedures · Requirements regarding referrals · Second opinion programs · Coverage determinations and appeals · Limitations and health plan coverage (iii) Prospective vs retrospective review- both cost containment controls can be a problem · Prospective (pre-authorization)- people might not get the care they need · Retrospective (post-utilization review)- pt and/or hospital will be out money if do procedure then deny coverage

Certification vs licensure

(i) Licensure- strictest (doctors, APN, RN) (ii) Certification- much lower bar in terms of educational requirement (iii) Supervision exceptions · Some states have a disclosure requirement that have to inform people that you aren't certified (iv) TN- direct entry midwives must be certified; PAs just operate under a physician (there are no specific education requirements)

Concerns Over Quality of Care: Administrative Process

- Administrative process kind of similar to that for licensure board issues · At hearing, physician can be represented by an attorney. The proceedings are privileged because they are part of peer review -Steps in Sokol (1) Complaint received and sent to Medical Council (2) Med Council appoints Ad Hoc Investigatory Committee (3) Investigatory Committee interviews P 3 times; makes recommendation to Medical Council (4) Medical Council reviews recommendations and provides notice of decision to implement practice restrictions (5) Ad Hoc Hearing Committee conducts hearing for P and recommends that Medical Council restore all privileges (6) Medical Council rejected the recommendation and reaffirmed its original decision (7) Exec Committee of the Board of Trust reviews decision and reaffirms decision of Medical Council

Licensure/ Accreditation of Nursing Homes: Quality Control

- Because quality control in nursing homes is difficult, increased need for public regulation a. Most people end up in nursing home because of acute medical incident and can't be discharged home: go wherever there's an open bed b. Not all are Medicare/ Medicaid providers c. Private accreditation like JCO is not well established or influential d. Nursing home residents rarely bring suits for substandard care (i) Causation can be difficult to prove (ii) Some physical injuries caused by ordinary contact (iii) Mental impairment makes for poor witness (iv) Limited remaining life span minimizes potential damages award e. Frequently include binding pre-dispute arbitration clauses in admission agreements (i) 2016- said can't make signing the arbitration clause a condition to admission (ii) 2017- got rid of this (iii) 2019- walked it back again: Nursing homes can use arbitration clauses but resident has to have an understanding of what that means and acknowledge their understanding, and can't be a condition of admission

In re Estate of Smith v. Heckler

- Because the purpose of the Medicaid Act is to provide high quality medical care, regs promulgated by the Secretary were facility-oriented, thus the Secretary had failed to follow instructions of Cong and the regs promulgated were arbitrary and capricious 1. Regulations structural but should be process/ outcome

Concerns Over Quality of Care: Immediate Suspension

- Can be a remedy where there is a serious concern for pt safety (i) Hearing rights are still in place, but allows the hosp to ensure that no quality issues occur while hearing is pending (ii) Typically seen in cases where physician has a drug or alcohol problem and is showing up for sx drunk or high

Actual Agent (Employee) Test

- Control Test (if meet these factors then physician is an agent of the hospital, and the physician's liability is imputed on the hosp) a. Factors required to establish an agency relationship (i) The principal must consent, expressly or impliedly to the agent's acting on the principal's behalf; AND (ii) The agent must be subject to the principal's control · Focus is on whether hosp generally controlled, or had the right to control, the conduct of the doctor in his work performed at the hosp · Doctors must be free to exercise independent medical judgment · Factors to consider: can hospital fire physician for poor performance; compensation; etc

Entering into Exclusive Contracts: Mateo-Woodburn v. Fresno Community Hosp

- Courts permit hospitals to make decisions regarding closure of medical staffs - F: Open staff dept for anesthesia so anyone could apply for privileges. Resulted in "cherry-picking" of the best pts--> least qualified were getting the low-paying pts and not matching difficulty level of pts with proficiency of providers. Decided to move to a closed system where the hosp would contract with an anesthesia group, so did away with privileges for non-contract anesthesiologists. Hosp said either sign a contract with Hass PC or don't work here. Part of contract is that if contract is terminated then all of your privileges are terminated - H: Finding hosp was permitted to close anesthesia dept--> Hosp could do this because it was in the public interest. Given the quality of care issues with staffing, the decision to close the staff was not arbitrary or capricious (and no waiver of DP)--> court will not interfere with the contract b/w the PC and physicians - R/R (i) SOR: arbitrary, capricious, or irrational (ii) Hosp could raise HCQIA because it was about pt safety (quality) even though it was not r/t the abilities of a particular provider · Contractual model helps with quality because can write into the contract how work will be divided, how to assign providers to cases, etc

Financing Part B

- Currently funded by general revenues and premiums - Slightly means-tested--> higher premiums for those who make more money

Doctrine of the Particularly Susceptible Victim

- D must take P as D finds the P--> doctor supposed to tailor tx to THAT pt · Ostrowski- Podiatrist knew that P had diabetes, and thus poor circulation, so she should have taken that into account and not removed the toenail

DRG Payment System- Medicare Part A (adopted by Medicaid and Commercial Payors)

- DRG= Diagnosis Related Group- payment based on a particular disease or condition a. Sets a predetermined rate based on the particular diagnoses or condition(s) rather than a direct reimbursement for costs b. Most payors have adopted DRG system- All Pt DRGs vs Medicare DRGs c. No judicial or admin review for amount of the DRG d. Some criticize DRG system beucsae it has nothing to do with quality of services, and simply encourages hosp to take more and more pts and try and d/c them quickly

Scope of Practice

- Discipline of individuals who are licensed in a profession, but are providing services typically provided by individuals in another licensed profession) - Licensed non-physician HC providers can't legally practice medicine, but practices that fall within their own licensure are not considered the practice of medicine a. Most common issue between NPs and Doctors b. SOP regulation focuses on boundary setting between professions and attempts to separate medicine from nursing from other HC disciplines

IC: Battery Actions

- Don't need negligence--> can sue even if there is no injury - Infrequent today because would have to stem from a total absence of consent (ex) infuse Jehovah's Witness with blood when they said no; operate on wrong body part

Negligent Credentialing

- Duty to select and retain competent physicians a. Hosp owe a duty of care to its pts to ascertain that a physician is qualified to perform sx before granting that physician privileges b. Another issue is whether there should have to be negligence established by physician prior to negligent credentialing suit

Armstrong v. Exceptional Child Center

- F: Providers of habilitation services in Idaho sued two officials in Idaho's Dept of Health and Welfare claiming that Idaho violates §30(A) by reimbursing providers of habilitation services at rates lower than § 30(A) permits (basically the rates are so low that no providers are willing to offer the service) - H part 1: the Supremacy Clause does NOT create a private right of action and the Ps can also not proceed against Idaho in equity because Cong did not explicitly indicate this outcome (likely because the scheme is so complex that we need the federal agency to provide expertise and uniformity, which would not be possible if it were decided by courts) (i) Relief must be sought initially through HHS rather than through the courts - H part 2: Ps do NOT have a right of action under the Medicaid Act itself (i) "Rights" under the Medicaid Act are akin to 3P beneficiaries and providers (Ps) are NOT the intended beneficiaries here (intended beneficiaries are the recipients)

Linton v. Commissioner of Health and Environment 1990 (Linton Law)

- F: TN had a limited bed certification policy (distinct part certification) which allowed Nursing Homes to certify only a portion of its beds as available to Medicaid pts. Linton was at Green Valley receiving SNF level care and informed by state that she needed only ICF level care. Green Valley informed Linton that she would have to go elsewhere because although her bed was dually certified for Medicaid for SNF and ICF level care, Green Valley reserved the right to decertify her bed for Medicaid ICF participation - H: TN's "distinct part certification" leads to disruption of care and displacement of Medicaid pts--> implicates Title VI because has a DISPARATE and adverse IMPACT on minorities because disproportionate amount of black population are on Medicaid (i) Super high percentage of African American population unable to get a bed in nursing home

Westside Mothers v. Havemen

- F: Westside Mothers file a claim under Section 1983 (civil rights claim) alleging that Michigan refused or failed to implement the Medicaid Act, its enabling regulations, and its policy requirements. - H: Reverse MSJ in favor of Michigan. Ps have a right to sue under § 1983 (i) This did NOT open the door to any and all sections of the Medicaid statute--> only those that pass the Blessing test --> reasonable payment provisions are pretty much the only thing you can bring under § 1983 · Statements of policy (e.g., 42 USC § 1396(a)(30)(A) provider payment provisions) - R/R (i) Medicaid is a federal law and not a contract (ii) Acts passed under the Spending Power are Supreme Law of the Land (iii) Case can proceed under Ex parte Young because the Ps brought a claim seeking only to prevent the Ds form doing what they have no legal right to do (correct behavior of state officials)

Concerns Over Quality of Care: Sokol v. Akron General Medical Center

- F: limitations placed on physician's CABG privileges d/t high risk-adjusted mortality - H: Medical Council's decision was not so wrong as to be arbitrary, capricious, or unreasonable given physician's high mortality rate. Physician was provided with sufficient notice of the claims against him and was provided with an opportunity to appeal in accordance with applicable procedures of bylaws

IC: Negligence Action- Decision Causation

- Failure to disclose caused the pt's consent (1) Objective test (majority)- what a prudent person in the pt's position would have decided if suitably informed of all perils bearing significance (a) If the prudent person would have declined tx when adequately informed--> causation is shown (Canterbury) (b) Pt's testimony may be relevant but it isn't dispositive (2) Subjective test (minority)- what the particular pt in this situation would have decided if they had been adequately informed

Merit-based Incentive Payments (MIPS)

- Fill out a report card on an annual basis that concerns quality metrics (i) There is no additional money that is paid: essentially, take money from people that aren't performing well under MIPS and give it to people that are performing well (everyone receives a payout or gets charged a penalty)

The Cost Conundrum: Suggested Solutions

- Function more like Mayo Clinic: i.e., coordinated care; alternative payment structures; pt-centered approach - Accountable Care Organizations- necessary because we are not structured like Mayo

healthy vs sick

- Hard to explicitly define. Definition of illness has serious effects on taxes, insurance coverage, jobs, etc 2. Disease (AMA)- (1) an impairment of the normal functioning of some aspect of the body; (2) characteristic signs and symptoms; and (3) harm or morbidity

Vicarious Liability of Hospitals for Negligence of Medical Staff

- Hospitals are only liable for acts of independent contractors based on vicarious liability (trying to sue hospital for physician negligence) --Exceptions to general rule that hosp can't be held vicariously liable for negligence of a doctor affiliated with the hosp, but not a hosp employee 1. Actual Agent (employee) 2. Apparent Agency 3. Implied Agency

How can HIPAA be used in relation to a private suit for breach of confidentiality?

- Individuals can bring a Breach of Confidentiality suit and use HIPAA as standard of care; can also serve as sub for causation--> because we know you didn't follow HIPAA, we know your behavior wasn't consistent with the SOC (so basically instead of having to go through the common law breach of confidentiality elements, could use HPAA as a substitute)

EMTALA: Negligent Screening

- Key element is NOT adequacy of the screening, but whether it deviated from the hosp's standard screening procedure that would have been performed on another pt in a similar condition (i) Requires hosp to develop a screening procedure designed to ID such critical conditions that exist in symptomatic pts (a minimum screening tool) and apply that screening procedure uniformly to all pts with similar complaints (ii) There could be a level of screening that is consistently applied to all pts, but that is so bad, it's inappropriate as applied to all pts (iii) EMTALA was NOT created to establish a federal med mal right of action (iv) Really no motive component to EMTALA

Medicare Coverage Determinations: Local Coverage Determinations (LCDs)

- LCDs are made by your Medicare Administrative Contractor (MAC) (i) MAC- 3P insurance companies that are responsible for processing Medicare claims in their jur (9 jurs) (ii) More common and more strictly to the local MAC · If deny coverage, these reviews have to go first through an ALJ and then can go to the Dept. Appeals Board for Medicare and then to court (iii) There are certain MACs where something will be covered as a part of a LCD that isn't covered by other MACs (ex) Nordian decides to cover acupuncture but no other MAC does

Traditional Staff Privileges and Medical Staff Membership

- Physicians often have "privileges" to admit pts and/ or perform procedures at a hospital and are "members of the medical staff" of the hosp under the hosp's medical staff bylaws a. Physicians are NOT employees of the hosp--> what hosp bills for are "facility fees" b. No money exchanged between the hosp and physicians c. By and large hosp have A LOT of control over who is on the medical staff and who can provide services d. Removal of hosp staff membership or privileges is NOT the same as licensure issues, but if hosp take a step that is considered an "adverse action" against a physician on the medical staff that relates to quality of care, must report it to the National Practitioner Database

Title VI of the Civil Rights Act

- Prohibits discrimination on the basis of race, color, national origin (including use of criteria or methods of admin that have the EFFECT of subjecting individuals to discrimination) by programs receiving federal assistance a. Applies to physicians and hosp - Enforced by the Office of Civil Rights or private right of action a. Court removed disparate impact actions from individuals (Alexander v. Sandoval 2001) but ACA seems to re-establish that for individuals

Section 1557 of the ACA

- Provides that "an individual shall not, on the ground prohibited under title VI of the Civil Rights Act of 1964" be excluded from participation in, be denied the benefits of, or be subjected to discrimination under, an health program or activity, any part of which is receiving Fed financial assistance 1. Appears to permit disparate impact claims and when enacted was intended to cover gender identity as part of "on the basis of sex" (transgender) 2. June 12, 2020- HHS issued final rule that removed protections based on gender ID from Section 1557 and further limited the entities "covered by the rule" (a) Entity must be "principally engaged in the business of providing HC" or entities for whom HC is funded by HHS (b) Also eliminates making this info known to individual with limited English proficiency

IC: Duty of Disclosure- Info on Physicians

- Specific qualifications of physician to be disclosed to pt where pt asks a specific question or where disclosure rises to the level of imposing an additional risk (Johnson v. Kokemoor) · If a reasonable person in the pt's position would have refused tx if they had received the disclosure--> must disclose -- so basically does something related to the physician meet the reasonable pt standard

Why some states prefer Medicaid Managed Care

- State is able to better balance its budget in a managed care system (there is a set amount set forth in the budget, and that amount is going to be static for at least a year) a. In a fee-for-service system, at the start of the year, the state really has no idea how much it's going to be spending

Medicare: Facility Administrative Appeal: Shalala v. IL Council of LTC Inc.

- Takeaway: facilities must also exhaust remedies through the administrative process and can't seek remedy in court unless penalties have been assessed - F: an association of nursing homes sued the Secretary of HHS in federal district court under federal-question jurisdiction. Claiming that regulations are unCon vague - I: did the federal court have jurisdiction to hear the case? - H: No. Council required to present its matter to HHS prior to review in a federal court - R/R: An individual or entity challenging the legality of a Medicare regulation must utilize the specific review process created by the regulation a. Can only get to court by having violated the law, appealed the violation, and exhausted the admin process (and dispute is over minimum amount requirement) (i) Exception- contesting methodology of the payment and there is no other avenue for contesting (you can bring it straight to court)--> Michigan Academy b. Courts have applied Chevron rule of agency deference more faithfully with respect to Medicare than in other areas (if HHS controls it all, then ensure that all beneficiaries are txed the same)

To prove that a P's condition is a direct threat, D must show:

- The existence, or nonexistence, of a significant risk must be determined from the standpoint of the person who refuses the tx or accommodation, and the risk assessment must be based on medical or other objective evidence · This does NOT mean that a physician can use just their own medical judgment to decide that something is a direct threat--> rather must assess risk of threat using objective, scientific info, available to him and others in the profession (if physician's medical judgment was part of the analysis then no one would ever be able to bring an ADA claim) (ii) Cannot rely on stereotyping or misconceptions

Statute of Limitations in general and in TN

- Time for filing of the claim has passed the time limits set out in applicable law--> completely throw out the case - TN- statute of limitations for med mal is 1 year from the date of DISCOVERY and no more than 3 years after the causative incident occurred (unless there was fraud). (i) Children have until turn 18 (ii) For foreign object left in the body, action must be commenced within 1 year after the alleged injury or wrongful act is discovered (gets rid of the 3 yr thing) · Discovery- requires knowing (or should have known) the occasion, manner, and means by which breach of duty occurred AND the ID of the D who breached the duty

EMTALA: Inappropriate Transfer

- To recover under EMTALA's transfer provisions, P must present evidence that: (i) Pt had an emergency medical condition (ii) Hosp had actual knowledge of the condition (iii) Pt was not stabilized before transfer; AND (iv) Prior to transfer of an unstable pt, the transferring hosp did not obtain the proper consent or follow the appropriate cert and transfer procedures

CHIP

- Totally OUTSIDE Medicare/Medicaid (i) Specifically for children where parents earn too much for Medicaid but not enough to actually afford insurance on their own · States get to decide how they want to do it, but it's NOT Medicaid · Money is supposed to go directly to families for them to purchase the health insurance

Negligent Infliction of Emotional Distress

- When standard negligence claim may not be available - Damages may be difficult to prove, but care was so sub-par that it created emotional damages

HIPAA: Covered Entities

- a health plan, a HC clearinghouse, a HC provider who transmits any HC info in electronic form in connection with a transaction covered by this subchapter (HC pros, insurance providers, medical centers, HC clearing houses, Business Associates) - Basically all providers these days are subject to HIPAA because everyone is online -- Exceptions: concierge physician that takes cash and does no billing

Shared Savings Program: Accountable Care Organizations (ACOs)

-ACO definition- retain cost control aspects of health maintenance organizations (HMOs) but add external oversight and regulations in the form of quality metrics, structural requirements, and "pt-centeredness" (closed-network concept) (i) physicians and hosp form a legal entity in order to try and better coordinate care. Incentivized to save because receive a share of the savings that are achieved to the extent that the group can reduce claims expenses in its pt population (ii) Must have 5,000 Medicare Beneficiaries (iii) Governing body must consist of at least 75% of ACO participants and Medicare beneficiary (iv) Can be just physicians or just hospitals, but most are a combo of the 2

ACO: One-Sided Risk Model

-ACO has only "upside" risk (1) ACO may receive up to 50% of savings to the extent achieved and ACO will not be responsible for the payback of any losses (2) Savings is offset by percentage of compliance with the 33 quality metrics; i.e., if ACO receives a score of 50% on quality metrics, ACO will only be eligible for 25% savings (3) Savings are capped at 10% of the benchmark (4) ACO may only participate in this for the first 3 years

Doctrine of Aggravation of a Pre-Existing Condition

-Also a "rule of damages," but NOT dependent on the conduct of the P (limitation on recovery still possible even if not fault of P) · Exists when P has a pre-existing condition and negligence makes that condition worse- the P can only recover for damages r/t negligence (recovery only possible up to the point of the pre-exisitng condition) (ex) P injured knee playing football in college and walks with a cane; P later involved in car accident and injures leg' doctor performs sx negligently on leg; P can't recover damages sufficient to restore leg to full use

Medicaid: Immigrants

-Anyone who is not "qualified" does not have coverage (including someone that is here legally) a. Work visas, student visas aren't covered

Standard of Review for Individuals Licensed within the profession

-Board's order must be supported by "reliable, probative, and substantial evidence" (i) All the court can do is decide whether the evidence was reliable, probative, and substantial--> court is NOT deciding if it agrees with the Board (ii) Dr. has already had the opportunity to argue his case at this point. All that can be done now is argue this evidentiary standard wasn't met (very difficult because that evidentiary bar is low) or that there was a procedural error · Procedural error changes the standard of review

ACA Pilot Programs and Other New Initiatives

-Centers for Medicare and Medicaid Innovation a. Center Established to try and test out payment reforms and approach new delivery models b. Provides grant funding to requestors who are able to try and implement new system or redesign methods to see what might be successful - Programs 1. Pt-Centered Medical Homes 2. Accountable Care Organizations 3. Value-Based Purchasing 4. Bundled Payments 5. Performance- based Care Coordination

More on Disparate Impact: Bryan v. Koch

-F: NYC closed Hosp after conducting thorough investigation on cost reduction measures--> Ps established a prima facie case of disproportionate racial impact but City acted without discriminatory intent and City's justification for closing Sydenham adequate (i) if the decision is neutral on the front-end Title VI does not require the city to engage in a different analysis to find a different alternative--> court doesn't want to get in the middle of finding the "best" option, just wants to make sure that the decision was neutral from the beginning (ii) might have been a successful disparate impact claim if the hospital had already closed and then could show statistics showing a disparate impact

ADA/ FRA: Howe v. Hull (also how an EMTALA claim would come out)

-F: P brought action alleging Ds refused to provide Charon with medical tx because he was HIV positive in violation of ADA and FRA - H: Under FRA, reasonable for jury to conclude the P was "otherwise" qualified for tx (planned to admit him originally) and that TEN dx was pretext; Under ADA reasonable for jury to find that D, despite the other reasons for transfer, improperly considered the P's HIV status - EMTALA claim wouldn't be successful here because they performed a screening and stabilized him before transfer--> even if hosp transferred him because of his HIV that does NOT matter for purposes of EMTALA because EMTALA doesn't concern motive (required to screen and stabilize, NOT to tx)

Corporate Negligence: Carter v. Hucks-Folliss

-F: P underwent sx at D hosp by Dr. Hucks-Follis who was not board certified and failed his certification test 3 times. Alleged negligent credentialing on behalf of D hosp. - H: Genuine issue of material fact as to whether hosp considered Dr.'s lack of certification in re-credentialing him - R: D agreed to be bound by JCAHO standards which said certification was a "factor" to be "considered" * Hosp could have avoided this situation by having better documentation that they did actually consider the fact that he wasn't board certified (again, HAVE to pay attention to own bylaws). Could have allowed him to remain on the medical staff but adjusted his clinical privileges

Ricks v. Budge

-F: P was a pt of Ds with a hand infection (D has been treating the hand). P came to D's clinic because condition of hand worse, Ds told him to go to hosp, then at hosp Ds refused to tx P because he had an outstanding account -H: There was a contract of employment (established pt-physician relationship) so doctors owed P a duty of continuing attention because his hand still required attention

Defenses to Duty of Care: Tunkl v. Regents of University of California

-F: Tunkl signed release releasing hosp from all liability - H: Exculpatory provision invalid because an agreement between the hosp and entering pts affects the public interest - Exculpatory provisions affect the public interest if certain characteristics are met · Nature of the business (does it see the general public) · Necessary service · Limited bargaining strength on the part of the pt · Contract of adhesion for services · Under control of "seller" and subject to risk - Hosp trying to argue charitable immunity- "if we're providing these services for free, then you shouldn't be able to sue for the care we provide--> Court not buying it--> something so broad as to ALL care would be immunity from standard of care

EMTALA: Baber v. HCA

-F: agitated ER pt with psych issue fell and hit head. ED performed screening and determined no serious head injury; any symptoms were r/t psych issue--> hosp won (i) No negligent screening- no evidence that hosp deviated from it standard screening procedure (ii) No Improper transfer- hosp did not have actual knowledge of pt's emergency medical condition

Duty of Care: Esquivel v. Watters

-F: baby died of gastrochisis but not informed it was seen on sonogram. Sonogram was strictly for determining gender of baby - I: Whether a legal duty of care exists on the part of the hosp? - H1: no pt-provider relationship between the P and the hosp because it was not treating her for any disease or illness, rather was telling her the gender of her baby. (no duty of care for care beyond specific tx) --> only duty it owed her was to perform sonogram without negligence, which it did (iii) H2: Dr. did not breach standard of care because there was no way to save the baby--> he did owe her a duty of care · No duty to discover- pt has to come to doctor with problem or has to be otherwise informed of issue

Sunshine Haven Nursing Operations v. US HHS

-F: bunch of complaints, surveys by state dept. Eventually revokes Medicare provider status - Standard of Review: review the Secretary's (ALJ) decision to determine whether the factual findings are supported by substantial evidence - H: Sunshine's petition to reverse the "Denial of Payment for New Admissions" and termination of provider agreement are denied, affirmed the determination of the DAB

IC: Canterbury v. Spence

-F: pt underwent laminectomy without Dr. informing him of risk of paralysis--> pt paralyzed · H: pt established prima facie case on the issue of disclosure--> Risk of paralysis is material and was reasonable for the physician to disclose under the circumstances

Duty of Care: White v. Harris

-F: telepsychiatry meet. Girl later committed suicide. This physician included in the law suit - I: Did he owe a duty of care? - H: consultation created a doctor-pt relationship and thus a duty of care. Remand to determine the scope of the D's duty and the standard of care. (duty of care exists even if contract attempts to limit duty) (iii) Although consultation of limited duration, still sufficient to support existence of a duty. The consultation/ his recommendations could have affected her care in a negative way

Actual Agent: Scott v. SSM HC St. Louis

-H: radiologist was an actual agent of the hospital (finding that jury could find D was effectively an employee) (i) Hosp contracted radiologist group's services. Hosp set standards for how to provide care and could terminate radiologists for poor performance

HCQIA Immunity

-Health Care Quality and Improvement Act provides immunity to hosp from credentialing decisions to the extent that such decisions meet procedural and statutory standards (have to be made based on QUALITY OF CARE) (ii) Credentialing decisions (decisions about privileges) are presumed to fall under HCQIA Immunity, but can be rebutted if Ps prove by a preponderance of the evidence: · Hosp did not act in the reasonable belief that the action was in furtherance of quality HC · Hosp did not make a reasonable effort to obtain the facts of the matter · Hosp did not afford the physician adequate notice and hearing procedures OR · Hosp did not act in the reasonable belief that the action was warranted by the facts known after such reasonable effort to determine the facts and after meeting the procedural requirements

Licensing Boards

-Licensure can become political in process d/t the regulatory structure of licensing Boards: State law controls the licensure of HC pros under the state's police power through "boards" a. Operate as administrative agencies and members are predominately professionals from the profession b. Governed by procedures and standards set in the state's licensing statute and admin procedures act c. Subject to judicial review of their adjudicatory and rulemaking decisions d. Not always considered to be within the State Action doctrine, so don't have immunity from anti-trust laws--> can't send out cease and desist letters. So now most states make sure that there is sufficient involvement from the state to get the Board within the State Action Doctrine (adequate supervision and active role)

Traditional Medicare

-Medicare Part A and B (have the option of adding Part D) - Can get it anywhere in the country: there are no networks - The coverage is more limited than Medicare Advantage - NO out-of-pocket maxes

Contributory Negligence

-Old rule but still followed by some jur -If P contributed at all to the injury, P can't recover--> total bar to recovery

Medicare Part A: length of stay

-Only covers 90 days in hosp per benefit (each stay in a hospital) and an additional 60 lifetime "reserve days" so if you are in the hospital for more than 90 days in a single benefit period, the hospital will start deducting says form your lifetime reserve days (can choose not to elect their lifetime reserve days, but would then have to pay the hospital out-of-pocket) (1) $1408 deductible for each benefit paid (2) Days 1-60: $0 coinsurance (3) Days 61-90: $352 coinsurance per day for each benefit period (4) Days 91 and beyond: $704 coinsurance per each "lifetime reserve day" (capped at 60 over a lifetime without Medigap plan)

Value Based Purchasing

-Percentage of hosp payment to performance on high-cost conditions, r/t process of care, experience of care, and outcomes a. Measured via established metrics and incentive payments are provided to the extent that you meet quality metrics (i) E.g., Hosp participating in MI value-based purchasing pilot will receive a reduced DRG for stay, but will track metrics prescribed by CMS. To the extent that the hosp reaches its achievement score or improvement score, CMS will make incentive payments

Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)

-Reauthorized the CHIP program and eliminated the physician sustainable growth rate -Also created MIPS and APMs- 2 new value-based reimbursement programs- both programs attempt to tie increases in reimbursement or shifts in reimbursement to quality improvements as opposed to increases related to cost-of-living or other adjustments - Directed CMS to come up with new reimbursement structures that will reduce pharmaceutical costs under Part B by reimbursing drugs

ACA: King v. Burwell

-Reiterates the fact that the ACA goals are intertwined and all pieces and parts have to fit together in order for the law to work as contemplated -tax credits are available to individuals who purchase insurance either on a state exchange OR on a fed exchange a. Issue with the way the ACA was drafted. Basically. Said people in state Exchange could get tax credits but didn't say anything about Fed exchange b. Court determined that the guaranteed issue, individual mandate, and insurance credits are so intertwined, that you have to interpret one based on the intent of the other

Exculpatory Clause

-Releases of liability are generally void against public policy to the extent that the service is a public interest (Tunkl), however, courts may accept limited releases related to a pt's assumption of a specific risk (Shorter) (i) Assumption of the risk can be argued as a defense (ii) If these limited releases weren't allowed, Drs would never tx these pts because the pt is doing something against medical advice of the Dr. as related to a specific procedure (limited liability protection) -so can't have a complete limitation of liability if you're a hospital, but can have releases that limit liability for specific things

ACA: TX v. US

-Tax Cuts and Jobs Act of 2017 set the penalty ("shared-responsibility payment") for not purchasing insurance at $0 What does this mean for individual mandate and ACA overall? a. Standing (i) Individuals: injury-in-fact is · Having to pay for insurance you don't want and not doing so is unlawful--> interesting argument considering there is no penalty for not purchasing insurance and NFIB said it wasn't unlawful not to purchase, just a penalty (ii) States- fiscal injury as employers b. Constitutionality of the Individual Mandate (i) Court determined it's unCon because no longer have the shared-responsibility payment pulling it in to Constitutionality c. Court remanded to lower court to examine severability of individual mandate in depth

Economic Credentialing: Mahan v. Avera St. Luke's

-adverse decisions based on economic reasons may be given deference if affects viability as a whole) - F: hosp closed its medical staff with respect to physicians requesting privileges for 3 spinal procedures and closed staff for ortho sx privileges because hosp needed to generate revenue from these surgeries (basically anything that requires overnight stay is only going to be performed by doctors working for hosp). P was physician at competing Am-Surg clinic who ASL refused to grant privileges to - H: Hosp was permitted to deny privileges to ortho surgeon d/t economic considerations for limiting ortho procedures--> Board has the authority as a matter of corporate law to make decisions without consulting the medical staff and such decisions were not made in bad faith

Financing Part A

-currently paid for by payroll tax -yearly deductible and daily co-pay after 60th day in the hosp

Scope of Practice: Standard of Review

-de novo - Medical Board doesn't have authority over a Nurse to make them appear before the medical board. Typically Board sends a cease and desist letter, and if that isn't followed then next step would depend upon regulations of the state. - also can do what nurses and doctors did in Sermchief and seek a declaratory judgment

Standard of Review for Individuals who are NOT licensed in a Profession

-de novo a. Unlicensed providers are NOT within the jur of Med Board or Board of Nursing, so can't go through the administrative process b. Boards file suit seeking an injunction to stop the unauthorized practice

Donabedian: Outcomes Standards

-measure actual improvement or decline in pt's heath status a. Look at quality based upon how the residents are fairing b. (ex) how many people are on psychotropic drugs, bed sores c. ACA is largely outcomes driven (value based) d. Problem: onset, duration, and extent of desired health outcomes hard to specify; hard to credit good or bad outcome specifically to a certain intervention

Donabedian: Process Standards

-relate directly to the activities that take place in the delivery of care a. (ex) Process for writing med orders; procedure for handwashing; upon admission must ask about pain and provide meds prn (i) Failure to comply with requirement that facility ensure that resident who can't perform ADLs receives services to maintain good hygiene b. Problem: Still leaves out the actual outcome of the process

Donabedian: Structural Standards

-the human, physical, and financial resources needed to provide care a. Much of quality control regulation in the past has focused here because it's the easiest to implement b. (ex) personnel, equipment, buildings, budget and expenditures; failure to have sprinklers, smoke detectors, etc c. Problem: don't measure whether care is actually any good, only that the tools required for good care are present

Medicare: Eligibility

1. 65+ 2. any age who have ESRD 3. Currently disabled and unable to work 4. Any age who have ALS 5. If not eligible for Part A at no cost, can buy Part B (without Part A), if 65 and older and a US citizen or lawfully admitted noncitizen who has lived in the US for at least 5 years

IC: Negligence Action

Allege that doctor failed to disclose important info to the pt prior to obtaining the pt's consent and resulted in injury (more common) -need duty, breach, causation, and harm

Medicaid: HCBS waivers

Allow states to do something a little bit different with regard to Medicaid

Nursing Home Regulatory Structure

1. Accreditation is NOT required and there is no "deeming" status: might want to be accredited as a marketing tool, but not necessary 2. Have to meet State regulations 3. If Medicare/ Medicaid provider and there is a complaint lodged, it's the State Dept. of Health that conducts the inspection: nursing home is mostly dealing with state regulators (through Dept. of Health based on Conditions of participation) 4. Almost all nursing home coverage is Medicaid. Medicare will only cover services in a SNF for up to 60 days after a minimum 72 hr hosp admission

Employer driven health insurance system

1. Advantages a. Employer pays for part of the cost and incentivizes other businesses to provide good health plans 2. Disadvantages a. Choice issues b. Job lock- if someone had a pre-existing condition (pre-ACA), then really couldn't leave their job because weren't able to obtain insurance c. Ties HC to the economy- as unemployment increase, the number of uninsured increases

ACA: NFIB v. Sebelius

1. Cong does not have the power to require the individual mandate under the Commerce Clause or N&P Clause, but the penalty required to be paid by individuals to the extent that they do not purchase insurance is within Cong's power to lay and collect taxes--> ACA is constitutional because it is within Cong's authority under its taxing power a. This is a tax and not a penalty (i) Penalty- punishment for an unlawful act or omission and the burden is so high that it's considered a punishment (ii) Tax does not exact the same burden b. Because the Court did not recognize the HC industry as a comprehensive scheme under the N&P clause or Commerce Clause, constitutionality hinged on finding that the individual mandate requiring everyone to purchase insurance or pay a penalty is a tax

Hospital Regulatory Structure

1. Dept. of Health (State Licensing Board)- have to meet a whole bunch of state regulations (ex) hallways must be this wide, there must be this many sinks, etc. 2. Accreditation from third party companies (Joint Commission) (i) Nongovt voluntary activity in which provider organizations voluntarily agree to be reviewed and assessed by the agency in exchange for "accreditation" (ii) Compliance with accrediting agency is deemed compliance with conditions of participation in Medicare/ Medicaid (iii) This is the entity that actually comes to do an inspection if there is a complaint of violations (also, might be that State licensure body relies on accrediting agency) (iv) Purpose of Medicare Improvements for Pts and Providers Act (MIPPA)- stricter regulation for Accreditation Organization- requiring more oversight

Test for Corporate Negligence

1. Hospitals owe a non-delegable duty directly to its pts in 5 categories--> injured party does not have to rely on and establish the negligence of a 3P 2. Must show hospital has actual or constructive knowledge of the defect or procedures which created the harm 3. Hosp's negligence must have been a substantial factor in bringing about the harm

Medicaid Benefits

1. Made up of mandatory and optional benefits (chart on 698) a. Mandatory: in-pt and out-pt hosp services; lab and xray; nursing facilities; rural health and FQHC services; early and periodic screening, dx, and tx services (EPSDT); fam planning physician services; and nurse midwife and NP services b. Optional: run the gamut and are determined based on determinations at the state level 2. Required by Fed law to specify the "amount, duration, and scope" for each category of service that is provided

Health Coverage Safety Nets

1. Medicare- elderly 2. Medicaid- indigent (but not all) 3. VA- veterans 4. TRICARE- military 5. Indian Health Services- Native Americans 6. Public Health Centers- all, including indigent (States and Cities) 7. FQHCs- all, including indigent 8. Govt Hosp and Clinics- all, including indigent 9. Non-profit hosp and providers

Goal of ACOs

Bridge different goals/ needs of hosp and physician--> increase coordination of care (i) Hosp is incentivized to provide as little care as possible because hosp get paid based on dx (ii) Physicians get to bill for each individual thing they do physician doesn't have the motivation to get that pt out; physician gets to decide when to d/c the pt, NOT the hosp

Medicaid Funding

1. Not all states receive the same amount of matching form the fed govt: ranges form 50-74% a. Newly eligibles were at 100% through 2016 and now 90% 2. Pays on a fee-for-service basis (or pays money to managed care, which also largely pays on fee-for-service) and participation by physicians is completely voluntary a. Has led to low participation

Hospitals vs nursing homes

1. Patients v. residents 2. Way more quality control mechanisms in hosp 3. Staff in nursing homes a. Not a doctor regularly there b. Most people working there are not licensed pros c. Not as much internal quality measures in terms of staff groups

RVU payment System- Medicare Part B

1. Physician services are paid based on a fee schedule that is organized according to Common Procedural Terminology (CPT) codes 2. Each CPT code is determined based on a weighted average of 3 components: (a) Work Relative Value Unit (RVU)- work performed (b) Practice Expense RVU- cost of performing work (c) Malpractice RVU- cost of malpractice insurance (basically physicians are incentivized to just provide as many services as they can) 2. RVU is paid on the value that CMS attaches to the difficulty of that particular clinical activity (a) Adjusted for geographic practice cost index (b) NOT adjusted for skill or level of expertise of the physician

Section 1115 Waivers

1. State waiver programs must be experimental and must further Medicaid objectives to furnish medical assistance and rehab 2. Waivers are frequently used for states to experiment with demo projects 3. Medicaid waivers seeking to add work requirements have been approved or are pending in several states --> recently, most of the waivers that have been sough have been to restrict who's eligible 4. Most states run their Medicaid off one or more waivers, to Medicaid varies drastically from one state to another

Donabedian 3 major approaches to assessing quality

1. Structural Standards- the human, physical, and financial resources needed to provide care 2. Process Standards- relate directly to the activities that take place in the delivery of care 3. Outcomes Standards- measure actual improvement or decline in pt's heath status

HIPAA: Marketing Rules

Can't sell a list for profit. Could give list if you're doing it just to give your subscribers more info

Concerns Over Quality of Care: Standard of Review

2 Approaches 1. Minority (Sokol)- look at the decision itself (whether decision of medical staff/ board of trust was arbitrary and capricious) (a) can also look at the procedural elements, such as, notice 2. Majority- restrict review to the question of whether the hosp followed its own bylaws (policies/ procedures)--> won't look at the merits of the privilege decision (a) Notice- must be sufficient to inform physician of issue, so that he can present a defense at hearing

Breach of Confidentiality

Common Law - Elements · Unconsented, unprivileged disclosure · To a third party · Of nonpublic information that · D had leaned within a confidential relationship -Don't need expert testimony to establish what a national standard of care is for keeping confidentiality--> standard of care is the existing protocols in place at the hospital or HIPAA--> jury just has to look at whether the hospital actually followed those protocols

3 categories of violations related to licensing

A. Individuals Licensed within the Profession (for action deemed unprofessional or contrary to the standard of care) -In re Williams -Hoover v. The Agency for HC Administration -In re Guess B. Individuals who are Not Licensed in a Profession (but are providing services typically requiring licensure) -Board of Healing Arts v. RUebke C. Scope of Practice (discipline of individuals who are licensed in a profession, but are providing services typically provided by individuals in another licensed profession) -Sermchief v. Gonzalez

Why are HC costs higher in the US?

A. Lack of transparency in prices so no competition: hospitals can charge whatever they want B. Administrative cost is huge C. Different states have different insurance coverage D. When take both health services and social services into account in comparing spending with return, US is a moderate spender with moderate returns: investments in larger systems of economic, environmental, and social support produce heath and support well-being 1. Environmental factors, such as food insecurity, house insecurity, environmental hazards, and poor education have a greater impact on heath than medical care; that's why we're thinking about social determinants of health a. (ex) insurance paying for transportation to appointments--> ultimately going to save money if person can get to the appointment and get the care they need

EMTALA and Insurance

ACA has a provision that requires insurance companies to pay for emergency care under a "prudent layperson standard"--> if a prudent lay-person would believe the emergency services to be medically necessary

HITECH

Added because basically no one was taking HIPAA seriously and wanted them to; also wanted everyone to switch over to electronic records

Pt-Centered Medical Homes

All care is coordinated through a PCP, who will be able to reduce duplication and inefficiencies because care will be coordinated centrally (have to go back to the home before doing anything else)

HIPAA: Definition of Breach

An impermissible use or disclosure of PHI is presumed to be a breach, unless it can be demonstrated that there is low probability that PHI has been compromised based upon a risk assessment

Duty of Care

Asking whether care is owed to a patient (whether a physician-pt relationship has been established) -NOT the same as SOC -this has to be proved first in a negligence/ med-mal claim

Next Generation ACOs

Attempt to solve beneficiary attribution problem--> created to bring in the Mayos and other places that already had an integrated care system but had a lot of specialists, and not as many PCPs (1) Allow some percentage of beneficiaries to be attributed to specialists rather than PCPs

Does EMTALA provide a private right of action?

Baber v. HCA -Provides a private right of action against hosp but NOT against physicians (govt enforcement against both hospital and physicians) -Causes of Action: negligent screening and improper transfer

"Direct Threat" defense to violation of ADA

Bragdon - Direct threat- significant risk to the health or safety of others that can't be eliminated by a modification of policies, practices, procedures, or by the provision of auxiliary aids or services (question is not whether there is a risk, it is whether it is significant)

Apparent Agency and ED Physicians

Emergency physicians typically considered agents because in an emergency situation there is no time to learn every physician's relationship to the hosp or go somewhere else if you don't like that the physicians aren't employed by the hosp--> reasonable belief by consumers is that the physicians in emergency rooms are employees or agents of the hosp (Tunkl already told us that hosp can't disclaim all liability for emergency room situations)

Financing Medicare Generally

Does NOT cover all services and even for those services that it does provide, may have limits and high out-of-pocket costs

Economic Credentialing and HCQUIA

Economic credentialing typically wouldn't fall under HCQIA, but could make an argument that did this so that hosp could generate enough revenue to offer other necessary, less lucrative services

Dual Eligibles

Eligible for both Medicare and Medicaid a. Low income individuals who are disabled and can't work b. Low income over 65

Defense to Duty of Care

Exculpatory Clause and Assumption of the Risk

EMTALA

Federal Emergency Medical Tx and Labor Act- enacted in response to pt dumping -Focused on process

Medigap Plan

For people who have traditional Medicare and want to purchase a separate plan for something that isn't covered in Part A or B, or that is required to be paid out of pocket under Part A and B

Apparent Agency Elements

Hosp can be found liable for physician's negligence where P establishes that: (i) The hospital EITHER committed an act that would cause a reasonable person to believe that the physician in question was an agent of the hospital, or, by failing to take action, created a circumstance that would allow a reasonable person to hold such a belief; AND · Focuses on the acts of the hosp, and generally satisfied when the hosp holds itself out to the public as a provider of care · Generally deemed to have held itself out as a provider of care unless it gave the pt contrary notice (meaningful written notice) (1) For notice to be sufficient to rebut the reliance prong, would need to be done on an individual basis and not in an emergent situation (pt would have to be able to make an informed decision at a time they were capable of doing that) (ii) The P relied on the apparent agency relationship

Corporate Negligence

Hosp itself or its employees failed to do something (don't have to establish that physician was negligent)--> there is something about the delivery of care by hosp staff or decision- making that is negligent

Elements of ADA and 504 of FRA

Howe v. Hull a. Same except that FRA requires that the discrimination be based "solely" on the disability and the ADA permits a "mixed motives" argument start analysis with FRA because if it qualifies for an FRA claim then also qualifies for the ADA claim b. Test (i) [Eligible] P has a disability (ii) P was discriminated against (iii) Discrimination was [solely] on the basis of disability c. Key is to think about what do I have to show demo "solely" vs "mixed motive" decision

HIPAA: what do I do if I determine there has been a breach?

If determine there is a breach must notify the pts involved AND the Secretary of HHS

Medicaid: "Katie Beckett" option

Individual funding for children that are disabled that allows families to take care of the child at home, rather than requiring them to be institutionalized to qualify for funding

Hoover v. The Agency for Health Care Administration

Individuals Licensed within the Profession (i) opioid rx case (pain clinic)--> board had insufficient evidence on which to base its decision to supplant the decision of the hearing officer · Board didn't review the medical records, didn't cite the federal guidelines correctly

In re Williams

Individuals Licensed within the Profession -F: Prescribing meds for weight loss long term, which was not the majority view on correct prescription. -H: Willian's action was NOT illegal at the time of the prescriptions and expert testimony asserted Williams' action did NOT fall below the acceptable standard of care, therefore the Board could not supplant its judgment for the experts (1) The only evidence on record was the Dr.'s expert witnesses that testified Dr. did not fall below the acceptable standard of medical practice

In re Guess

Individuals Licensed within the Profession -F: licensed physician, unpro conduct for practicing homeopathy; Board revoked his license · statute: "departure from , or failure to conform to, the standards of acceptable and prevailing med practice...irrespective of whether a pt is injured") o Several physicians testified homeopathy is not an acceptable and prevailing system of medical practice in NC o Guess presented evidence of its use in other state and in other countries - H: decision of Board was not arbitrary and capricious (it was based on substantial evidence)--> "if supported by competent evidence, a Board's decision may not be disturbed by a reviewing court"

Board of Healing Arts v. Ruebke

Individuals who are NOT licensed in a Profession - I: whether Ruebke's action (as a lay midwife) constitutes the unauthorized practice of med or nursing - H: No. Lay midwifery was not contemplated by either act and under supervision of a physician (within an exception to the act) -R/R: "the fact that a person with medical training provides a service in competition with someone with no medical degree does not transform the latter's practice into the practice of medicine"

Adverse Event

Injury caused by medical management rather than the underlying condition (i) No single person at fault (ex) fall (ii) Doesn't necessarily imply negligence but often there is a res ipsa loquitur approach--> if there was proper management then the fall wouldn't have occurred, thus there must be negligence

Cost Conundrum: factors that complicate our HC system

Inverse Incentives - Hosp are paid based on a DRG--> incentivizes hospitals to reduce services and d/c pts quickly -Physicians are paid based on a fee-for-service system--> incentivizes physicians to provide more and more services because each service results in payment - In culture of over-utilization, pts and consumers also come to expect that "more is better" and physicians compete on "more"

Staff Privileges and Medical Staff Membership : Modern Trend

Is for hosp to hire physicians as employees or establish contract with a group

Apparent Agency

Looking at 3P perception (hosp is holding out to the public this person is an agent)

Hosp may terminate, limit, or deny hosp privileges for 3 main reasons

Majority of courts are hesitant to override the actions of hosp and med staffs when it comes to quality and even when it comes to business decisions a. Concerns over quality of care (Sokol) b. To enter into Exclusive Contracts (Mateo-Woodburn) c. Control physician's utilization and costs and avert competition (Mahan)

Inverse Incentives

Medicare Part A and Part B are reimbursed separately and under diff concepts, thus leading to different incentives under the program and encouragement away from working together to care for the whole pt (hence ACOs and alternative payment systems)

Medicare Advantage

Medicare Part C a. Covers same stuff as Part A and Part B with additional coverage, including extra hospital days--> purchase these plans through a private insurer (managed care companies) (i) Additional coverage typically includes dental and vision b. Most come with Part D c. Typically come in the form of an HMO or PPO--> both have specific provider networks d. Typically more expensive but there ARE out-of-pocket maxes

Financing Part C

Monthly premiums and deductibles and co-pays and co-insurance just like a commercial policy - Federal govt takes a chunk of it's money and gives it to the insurance companies, then the insurance companies are responsible for that money--> essentially transferring risk to insurance companies (i) Claim totals might come out over the at number or under that number (ii) So fed govt will give $30 billion to insurance companies. If insurance companies have to pay out $32 billion, then the insurance companies have to eat that $2 billion

Assumption of the Risk

More often used in cases where unconventional tx is applied, but is sometimes challenging unless acceptance of risk was absolutely clear

Test for Corp. Negligence: 5 Duties of Hosp

Nason (i) Use reasonable care in the maintenance of safe and adequate facilities and equip--> this is the same as a slip and fall action against a Walmart · Washington v. Washing Hosp- negligence of facility in not maintaining equipment that would detect intubation was improper (ii) Select and retain only competent physicians--> negligent credentialing (iii) Oversee all persons who practice medicine within its walls as to pt care--> referring to nurses and administrators and other hosp employees (Darling) (iv) Duty to formulate, adopt, and enforce adequate rules and policies to ensure quality care for the pts --> do you have a policy that is going to cause poor medical management? (Washington- negligence in not adopting intubation procedures) (v) Failure to uphold the proper SOC owed to its pts (Nason- negligence in hospital in failing to monitor and report changes) · This is a catch-all--> if you can't fit nicely into one of the other four, then we'll let you just bring your case under this · This is helpful to pts because it doesn't require them to point to one specific person who made one specific mistake--> hosp, you're in charge of everyone, and clearly someone or multiple someone's messed up

Are Medicare beneficiaries whose physician is participating in an ACO required to stay with their physician through the program year?

No

What does it take to create a duty of care?

Not much -no duty of care for care beyond specific tx -no duty to discover- pt has to come to the doctor with a problem or the doctor has to be otherwise informed of the the issue -A brief consultation can be enough to create a duty of care

TN post Linton

Nursing homes who are Medicaid certified must create a "wait list" for all pts and the next bed goes to the next in line, unless there is a medical reason for one pt to be admitted in advance of another

EMTALA requires

Provide a medical SCREENING to all pts who present to the hosp campus to determine if an emergency medical condition exists, and if so, stabilize the pt prior to transfer -screening and stabilization within the capability of the hospital's ED

EMTALA: If screening reveals an emergency medical condition (EMC), the hospital is required to ____ unless...

Required to stabilize the medical condition prior to any transfer, unless (i) Individual, after being informed of hospital's obligations and risk of transfer, requests a transfer in writing; OR (ii) Physician has certified that benefits of care at another facility outweigh the risks of transfer; AND (iii) The transfer is an "appropriate transfer"

Regulatory Structures: Licensure and Medicare/ Medicaid Certification

a. Must be licensed in the state in which the facility is located b. Must be certified by Medicare/ Medicaid if enrolled as a provider (i) Medicare and/or Medicaid provider (Voluntary)- both administered by federal govt but totally separate. Can be a provider of one but not the other, but rare. · This imposes a separate set of Fed regulations in order to be reimbursed

Performance-based Care Coordination

Similar to payment bundling but has quality metrics

Medicare

Social Program; NOT a welfare program

ACA: Changes for Insurers

a. No insurer can deny an individual for a pre-existing condition and pre-existing conditions covered on day 1 b. Insurance must have minimum coverage obligations c. Modified community rating- premiums adjusted for age, tobacco, and geography only e. No recission- plans can only drop coverage for deliberate misrepresentation f. Individuals up to 26 can stay on parent's insurance

Licensure: Telemedicine

a. Practice of medicine through electronic communications b. Most states require physicians providing medical services in their states' border to be licensed in the state (42 states require full licensure, and 8 allow for a telemedicine licensure) c. Pros: access, convenience d. Cons: no physical exam, abuse of prescribing, no uniform payment mechanisms

Common Law Contract Claims/ State Law Duty to Tx

Used prior to EMTALA -No common law duty to tx if there is no physician-pt relationship established (used prior to EMTALA) a. To the extent that no "contract' (either implied or express) has been entered into the physician is under no obligation to tx the pt at the time pt presents himself - In the ED you're almost never going to have a relationship with a physician, so basically ED physicians could legally turn whoever they wanted to away - Childs v. Weis- ER doctor refused to tx pregnant woman. Baby born in car on the way to another hosp and died--> affirmed MSJ for doctor (i) No contract established between Dr. and P, so no duty to tx--> freedom of contract prevents many common law claims where discrimination might be subtext

Adverse Selection

Want to avoid a situation where you only have people that really need insurance buying the insurance (need healthier people that won't actually require insurance to pay out a bunch for their HC to offset what the insurance is having to pay for sick people with pre-existing conditions)

Medicaid

Welfare

Med-Mal defenses: Causation

While negligence existed, it was not the proximate cause of the injury.

EMTALA: can hospitals ask about payment methods or insurance status

Yes, but can NOT delay medical screening to inquire -And can't require prior authorization before stabilizing an emergency condition and can't refuse to stabilize if pt says don't have insurance

EMTATLA does not require...

hospitals to tx the pt once stabilized; if no emergency medical condition, then do NOT have to do any intervention

ACA: Cost Share Reduction (CSR) Payments

a. Made directly from the fed govt to insurer on behalf of an eligible individual to lower that individual's cost-sharing obligations (deductibles, co-insurance, co-payments) b. Only applies to individuals with household incomes between 100-250% of the poverty line who enroll in individual silver tier plans through an ACA marketplace c. CSR payment stopped last year because Trump determined he was not going to pay them, thus insurance companies started jacking up the premiums for silver tier plans d. Sanford Health Plan v. US- Court determined that govt has to pay for outstanding CSRs, but that amount can be offset by the revenue from the increased premiums

ACA and Quality

a. Medicare will no longer cover "never events" and "HACs (i) Never event- amputating the wrong leg b. Hospital Readmissions Reduction Program c. Increased reporting obligations

Medicaid Eligibility

a. "Deserving poor"- aged (65+), blind, disabled (if qualify for SSI then disabled) b. "Categorically Needy"- Pregnant women, dependent children (through age 18) AND their relative care-givers c. Need LTC d. "Medically needy"- sufficient funds until medical expenses incurred cause indigence e. Expansion states- all individuals with incomes up to 138% of poverty line

ACA: Individual Mandate

a. (as originally drafted) To guard against adverse selection, ALL individuals were required to maintain health insurance either through their employer, a private plan, the individual marketplace, or a govt plan, or face a penalty, unless (i) Individual's income is below $12,760 (single) or $17,240 (married) and $26,200 (family of 4) (ii) Individual would have to pay more than 9.5% of their income in 2017 for insurance premiums (after employer contributions and subsidies) (iii) Citizens who earn less than 100% of the fed poverty line, but do not qualify for Medicaid expansion (because they are in non-expansion states)

ACA 3-legged Stool

a. Actual affordability- subsidies and credits b. Guaranteed coverage- can't deny people for pre-existing conditions; community rating c. Personal responsibility- individual mandate (King v. Burwell seems to adopt the concept that there is a scheme and one part of the scheme without the others frustrates the law)

ACA: Premium Assistance Tax Credit

a. Applies to Americans who earn between 100%-400% of the federal poverty line who purchase individual health insurance through an ACA marketplace, and is applied to insurance premiums * Individuals with incomes below 100% of the poverty line and who live in states that don't accept the Medicaid expansion will not be eligible for premium tax credits b. The credit applied is equal to the lesser of (i) Monthly premium costs or (ii) Monthly premium for second lowest "silver" plan for taxpayer and family minus 1/12th of the product of the applicable percentage and the taxpayer's household income d. A family of 4 earning $97,200 or less a year purchasing non-group insurance will be eligible for the credit

Medicare: Pt Claim Review Process ( In the Case of the Estate of WD)

a. Challenging a Determination- Individuals are required to exhaust remedies through the admin to bring Medicare regulation objections to court (i) Only way to challenge is to pay for the service, then seek reimbursement through the carrier after you receive services d/t a coverage denial decision (ii) If you can't afford the procedure out-of-pocket, then no way to appeal coverage because there is NOT a pre-approval process b. Admin Proceedings (i) Medicare Admin Contractor (MAC) denies coverage at initial determination (ii) File an appeal with MAC for a redetermination (iii) File an appeal for re-determination by Qualified Independent Contractor (QIC) (iv) Appeal to Administrative Law Judge (v) Appeal to Medicare Appeals Council (vi) Appeal to district court if amount in controversy is $1670 or more- Standard of review is abuse of discretion

Medicare Part D

a. Covers prescription drugs b. Can be from 3 sources (i) Can be purchased separately from Pharmacy Benefit Manager if on Parts A and B (ii) provided as part of Part C (iii) employer plan for employees and retirees c. Plans are individualized, but all include cost-sharing similar to standard commercial plans

National Practitioner Data Bank (NPDB)

a. Created by Cong to ensure that physicians who have been disciplined while practicing in one state can't just move from state to state b. State disciplinary and licensure boards, hospitals, and entities with peer review committees have to report c. Hosp have to confirm that newly hired practitioners are not listed and periodically confirm that existing employees have not been listed

3 basic policy goals of the ACA

a. Improve how pts receive and experience HC (ie, make it better--> quality) b. Improve the health of populations across the US (ie, let's eliminate a system of the haves and have nots--> access) c. Reduce overall HC costs for families and individuals (let's get people insured and subsidized--> cost)

To achieve the goals of the ACA, it focuses primarily on

a. Increasing access to insurance and the number of people who are insured b. Improving quality and efficiency within the current infrastructure c. Reducing costs in the system

4 ways state licensure boards can get involved with Complimentary and Alternative Medicine (CAM)

a. Licensed providers (doctors, nurses, dentists) utilizing CAM along with conventional medicine b. Unlicensed providers providing alternative therapies that may constitute the unlicensed practice of medicine c. Restrictions on practices of unlicensed providers in connection with the provision of CAM d. Some states will choose to license certain practices once they are more mainstream: acupuncture, chiropractor, massage

How is the DRG calculated?

a. Pt is admitted for sx, major chest procedure b. Standard amt for labor costs (nurses, janitors, etc; not physicians), non-labor costs (heat/ AC, water, bed) , and capital costs (the building) (1 set amount for each throughout country) are added then multiplied by one of 3 levels for sx severity c. That number is then adjusted based on factors such as wage-index factor, teaching hosp payments, and DSH payments (disproportionate share payments- care for a disproportionate number of indigent pts) d. So if hosp spends less on that pt--> gets to keep the excess; if hosp spends more on that pt--> has to eat that cost e. Amount that is going to be paid for the same procedure is going to be different for different areas beucsae all of these costs are different in different areas (ex) Cali pays its nurses way more than TN

ACA: Employer Responsibility

a. Sections 1511-1515 require employers to pay penalties for certain activities (i) If a certain number of their eligible employees buy insurance off the exchange as opposed to through employer-sponsored plans (ii) If employer requires employees to pay more in premiums than 9.5% of income or if insurance does not cover 60% of allowable expenses b. Intention is to avoid a situation where employers create plans that are so awful for employees that employees instead flood the exchanges c. Regulations allow time to transition (ie, in year one, offer coverage to 70% instead of 95%)

Generally, Medicaid is a payment program and thus does not guarantee certain types of coverage- there are some exceptions

a. States are limited in their ability to limit services under the Civil Rights Act (Olmstead v. L.C.) (i) Must care for people with mental disabilities in community-based programs rather than state institutions when the treating physicians think such care would be appropriate · Elimination of certain facilities might be acceptable under other circ including a comprehensive and effective plan for dealing with individuals with disabilities b. Harris v. McRae- upheld limitations on funding for abortions under Medicaid ("it simply does not follow that a woman's freedom of choice carries with it a Con entitlement to the financial resources to avail herself of the full range of protected choices")

Federal and State Regulation of Drugs

a. States traditionally regulate the practice of medicine as part of their police power, but fed regulates too b. FDA- Approve and monitor the safety of drugs and devices (gatekeeper): once a med is approved, a doctor can prescribe it for approved purposes or off label (i) Drug company can only promote med for its approved purpose (ii) State can take individual action against a physician it feels is prescribing against practice c. DEA- more directly regulates prescribing practices by the Controlled Substance Act--> enforcement arm (i) Schedule I-V: schedule I have the highest potential for abuse and "no" therapeutic benefit (marijuana and heroin) · Can't prescribe schedule I · Have to have permit to prescribe off other schedules · Can revoke permit or pursue criminal action against physician whose prescription and distribution of these drugs fall outside the DEA's view of legit medical practice

State's police power regarding licensure

a. Statute must have a rational relationship to a legit public purpose- protecting public health b. Such protections can include protecting from harm AND prohibiting practices that depart from prevailing standards (if choose alternative med that doesn't actually help, might forego tx that would have been curative)

IC: Decision Aids

a. Support tools that provide pt with detailed info b. ACA and other recent efforts have focused on the use of decision aids for pts as a means of providing info and involving the physician in shared medical decision making (i) Could negate IC claim if info is readily available (ii) ACA requires HHS to develop a certificate program for certain decision support tools and the Shared Decision-making Resource Center to provide technical assistance to providers

Administrative Process- What happens if board believes a licensed professional is not meeting the standard of care?

a. The licensed individual will receive notice from the Board stating exactly what they are under review for b. Meet with a Hearing Officer to explain and defend their self c. Hearing officer gives a recommendation to the Board. Board does NOT meet with the individual, simply looks at Hearing Officer's recommendation d. Board delivers its decision e. If the HC pro disagrees with the Board's decision, she can appeal it to a court

ACA: Health Insurance Marker-Places (Exchanges)

a. Where people go to sign up for coverage b. Stated had the option of setting up their own, or joining the Fed marketplace

Procedural Innovation: Brooks v. St. John's Hickey Memorial Hospital

action taken by physician was medical judgment, not medical experimentation, where physician had several compelling, professional reasons for choosing course of action --> procedural innovation is a valid defense

DRG Creep

aka upcoding; classify pts as higher level to get more money

Duty to Tx: Williams v. US

guy died after hosp on Indian Res refused to tx him no cause of action under the appliable claims because none provided a private right of action; hosp had no duty to tx because guy was not Native American