HPM310 Final

Look-back method vs Perspective method

- Basis of claims paid in the past for Medicare patients - estimating the amount that would be paid for that treatment by Medicare - Hospitals choose one of these two methods to determine AGB -- This a proposed rule

Name other ways to use regulation to protect public health

-Regulation of alcohol and tobacco (prohibiting purchase by children, and imposing taxes to discourage use) -Control of guns; and rules to prevent injuries at home, at work, and on the highway -Promotion of good nutrition (such as prohibition of trans fats, and labeling requirements for food) -Requiring approval of drugs and devices

CLASS Act

ACA's new program of voluntary insurance for long-term care services that requires premiums for this voluntary insurance program be high enough to assure solvency of the program for 75 years (without using any taxpayer funds to pay benefits). -Secretary of HHS notified Congress that it was not possible to implement the CLASS program in accordance with legal requirements on a financially solvent basis. It could not for sure honor its commitments to individuals who had already enrolled

How are healthcare professionals subject to government supervision?

If they are participants in federal payment programs

Are state law claims and remedies preempted for both insured and self-insured ERISA plans?

Yes, all ERISA plans are treated alike

Federal authority over health and healthcare is based primarily on the power of Congress to regulate ____.

"Interstate commerce" which is usually interpreted broadly (and courts have held that a wide range of activities can affect interstate commerce). But the federal government may not use its power to regulate interstate commerce to require all residents of the U.S. to buy health insurance-- while the state does have this power.

Gonzales v. Oregon

- A case of statutory interpretation of the federal Controlled Substances Act. -The U.S. Supreme Court agreed with Oregon, and held that federal officials may not penalize physicians who comply with Oregon law.

Define Appropriate medical screening examination for EMTALA

- Exam's purpose is to determine if the patient has an emergency medical condition. - Hospital may not refuse to provide X-ray or lab services located outside the ED if those services are ordinarily available to patients in the ED. -the EMTALA standard for an "appropriate medical screening examination" is the particular hospital's own practice. (This differs from malpractice standard of care which is based on care in the community)

What are the two additional statutory reporting requirements for hospitals in the ACA?

- First, a hospital must describe how it is meeting the needs identified in its CHNA. - Second, the ACA imposes an excise tax of $50,000 on any hospital which fails to meet requirements for a CHNA, and requires a hospital to report the imposition of that excise tax on its Form 990.

Tax exemption issues for healthcare providers participating in ACOs

- If a tax-exempt organization (such as a charitable hospital) participates in an ACO with private entities, it must be careful to protect its tax-exempt status. - The tax-exempt organization must make sure that its net earnings do not "inure" to the benefit of private parties, and it must not operate to benefit private parties. - Also part of the share might be subject to unrelated business income tax.

How does the federal government use its power as a large-scale buyer?

- Impose conditions directly on healthcare providers that participate in Medicare. - The Medicare program can use voluntary participation as a mechanism to impose requirements on healthcare providers

What are the two alternative legal test courts use for the element of causation?

- Subjective: rely on the testimony of the injured patient - Objective: reasonable person, in the circumstances of the patient, would have consented to the medical procedure if the risks had been disclosed.

What four specific laws about fraud and abuse does the ACO waivers cover?

- The Physician Self-Referral Law (also known as the "Stark Law") -The Federal Anti-Kickback Statute -The "Gainsharing CMP": The Civil Monetary Penalties (CMP) Law which prohibits hospitals from paying physicians to limit or reduce services to Medicare or Medicaid patients; and The "Beneficiary Inducements CMP": The Civil Monetary Penalties (CMP) Law which prohibits offering or giving something of value to Medicare or Medicaid patients that would influence their choice of provider.

What are the reasons federal law would play a role in end of life care?

- There might be a federal constitutional right to refuse treatment. But, such a constitutional right would not necessarily override a state's law that imposes conditions on refusal of treatment. - Federal law requires some healthcare facilities to inform patients of rights. Federal involvement is a statute enacted by Congress as part of the Medicare law. -Federal law attempts to discourage PAS (even if allowed by state law). Assisted Suicide Funding Restriction Act, (ASFRA) Congress has prohibited the use of federal funds in connection with assisted suicide.

Limitations on billing and collection

-A hospital may not take "extraordinary collection actions (ECAs)" until after it makes "reasonable efforts" to determine the patient's eligibility for financial assistance. - "Reasonable efforts" is defined to require notification, providing information to complete an incomplete application, as well as making and documenting a determination of eligibility for assistance.

Name some examples of illegal kickbacks

-A hospital that pays physicians a fee for every patient admitted to the hospital -A pharmaceutical manufacturer that pays doctors to prescribe a specific drug, or pays pharmacists to dispense a specific drug -An nursing home or home health agency that gives something of value to hospital discharge planners, in order to induce them to refer patients for services after discharge

What 5 separate ACO waivers have CMS and OIG established?

-ACO Pre-participation -ACO Participation -Shared savings distributions -ACO arrangements that raise issues under the Physician Self-Referral Law -Patient incentives

What is the process of administrative appeal of state CON laws?

-After the state CON agency has made its initial decision, a disappointed applicant generally has the right to an administrative appeal. -Parties must exhaust all administrative remedies before seeking review in the courts. -When all administrative remedies have been exhausted and the agency has made its final decision, a party may request judicial review.

Name the 3 categories of ethics in the health care field

-Bioethics -Professional ethics -Business or organizational ethics

How can states use their power to regulate insurance to indirectly control ERISA plans that buy insurance?

-By regulating the insurance company -A state "mandated benefit law" can require specific benefits to apply indirectly to an insured ERISA plan. But, under the deemer clause, ERISA plans can avoid state requirements by using the mechanism of self-insurance.

What are the goals of law of medical malpractice?

-Compensation (providing monetary damages to injured patients or their families) -Deterrence (improving the quality of care by getting rid of "bad" providers and causing other providers to be very careful).

How does the federal government use its conditional spending power?

-Congress may require states to enact particular laws as a condition of federal aid to the states. - For example, the Supreme Court held that Congress has the power to require states to enact certificate of need (CON) laws, as a condition of federal grants (even if that type of law would violate the state's own constitution). -BUT THERE ARE LIMITS, the Supreme Court held the federal government cannot withdraw existing Medicaid funds from states not participating in expansion of Medicaid.

What public policies might require disclosure of medical information?

-Control of infectious disease (Ebola) -Control of crime (such as gunshot wounds and child abuse) -Medical treatment (doctor to doctor) -Medical research -Other interests of patients (such as allowing a patient's family or friends to find out if the patient is still alive).

What are some of the penalties for fraud and abuse in Medicare/Medicaid?

-Criminal prosecution -Fines and monetary penalties -Exclusion from participation in government payment programs, which would drive most hospitals out of business. -Civil suits by "whistle-blowers" under the federal False Claims Act-- "Whistle-blowers" may receive millions of dollars as their share of money that healthcare providers must pay to the government. -ACA strengthened enforcement activities by requiring screening requirements for providers and suppliers and requirement for more compliance programs.

Define "duty"

-Doctors have a duty to their patients to meet the "standard of care." -Duty to reasonably disclose the risks -The "standard of care" is the treatment which is routinely provided by similar doctors, in the same or similar communities, under similar circumstances.

What does it say under ERISA preemption clause verse saving clause?

-ERISA preempts state laws insofar as they relate to employee benefit plans under ERISA. -State laws that regulate insurance are "saved" from preemption (and, therefore, are not preempted).

Examples of how hospitals get Paid-for-performance under Medicare

-Excessive rate of readmissions -Payments adjusted for patient satisfaction

Name some Stark Law exceptions

-For "in-office ancillary services" and for legitimate group practices, if they meet specific requirements. -For physician ownership of an entire hospital or chain.

Define Requirements for a proper transfer for EMTALA

-For a transfer to meet the requirements of the statute, it would have to be requested by the patient -The sending facility must provide treatment to minimize risk. -The receiving facility must have space and agree to accept the patient. -The records and documents must be sent with the patient. -The transfer must be accomplished with an appropriate vehicle and personnel.

How does the ACA increases the regulation of health insurance companies? (what patients do they have to insure?)

-Health insurance companies may not cancel a health insurance policy because a person becomes sick. -Health insurance companies may not refuse to cover people who have preexisting medical conditions. -Health insurance companies may not charge higher rates to people who are sick or have preexisting medical conditions.

What if the patient cannot make a decision or communicate a decision?

-In some circumstances, the law allows consent to medical treatment to be given by someone other than the patient. Ex. off life support -In some states, courts make a "substituted judgment" for the patient (by trying to determine what the court thinks the patient would have wanted). -However, other courts take a different approach and try to determine what would be in "the best interest of the patient." -The best evidence of one's desires is an advance directive (a will).

When will a particular project be subject to CON review?

-In some situations, a CON will be required only if the project involves a capital expenditure or annual operating cost that exceeds a level specified in the law. -In contrast, some activities which are listed in the statute will require a CON regardless of the capital or operating expense.

The fault-based U.S. system fails to meet what goals?

-It fails to meet the goal of fair compensation (like a lottery) -It fails to meet the goal of deterrence (under claiming not over claiming) -It fails to promote patient safety and improve quality of care -It increases health care costs -It distorts policy debates by incentivizing powerful stakeholder groups

What are some penalties ACA imposes for not having insurance?

-Large employers must pay penalties, if their employees obtain subsidized insurance through an "exchange". -Most individuals will be required to pay a penalty if they do not have health insurance.

Medicare Shared Savings Program (MSSP)

-MSSP encourages healthcare providers to cooperate, by participating in Accountable Care Organizations (ACOs), which provide incentives for efficiency and quality. - An ACO will take responsibility for the care of a specific group of Medicare patients. - Medicare reimbursement of healthcare providers, an ACO may receive its own payments from the Medicare program, if the ACO meets standards of quality and saves money for the Medicare program.

What are the cons if Medicare changed to a premium support (or voucher) plan?

-Might require beneficiaries to pay more for care -Might eliminate the traditional Medicare program -Private health plans might try to contain costs by using techniques of aggressive UR (Utilization Review) and limited provider panels (which caused a severe backlash against managed care)

What improvement did the ACA make in coverage or beneficiaries of the Medicare program?

-No cost-sharing for certain preventive services and annual assessment of health risks -Reduce and eventually eliminate the coverage gap in Part D drug coverage (the so-called "doughnut hole") -Add incentives for programs of behavior modification -Provide coverage for some persons exposed to environmental hazards, in areas of declared emergency

Give examples of how ACA allows for a competitive market for private insurance

-No national health system -No single-payer system of public financing, with private delivery of services -No public plan (as a competitive option to private health insurance companies for all U.S. residents) -Universal insurance exchange is not the only marketplace where everyone in the U.S. would be required to buy their health insurance

What are the pros if Medicare changed to a premium support (or voucher) plan?

-Places a limit ("cap") on federal government spending -Possibility of cost reduction due to competition among private health plans -Possibility that competition will improve quality

What are the goals of medical privacy and confidentiality?

-Prevent individuals from suffering embarrassment or discrimination -by encouraging individuals to: obtain necessary medical care and disclose relevant personal information to their health care professionals.

What payment changes did ACA make for providers and Medicare Advantage Plans?

-Reduce payments to some healthcare providers, but gave a 10% bonus to primary care physicians and to those general surgeons who work in areas with a shortage of professionals. -Reduce payments to those hospitals which provide a disproportionate share of indigent care. -Reduce the level of payment to hospitals which have an excessive rate of readmissions. -Revise payments to Medicare Advantage Plans, including some reductions, as well as some bonuses for quality plans.

What are some types of false or fraudulent claims in Medicaid/Medicare?

-Requesting payment for services that were not provided at all. -Misrepresenting the services provided, such as "upcoding" to get more money -Misrepresenting the patient's condition to meet requirements for payment -FERA made it a false claim to not pay an obligation which is owed to the government. The ACA provided that overpayments must be reported and repaid by a deadline (60 days from discovery). The government sues a healthcare provider for so much money, settlement is the only practical alternative because of how expensive it is. -It is also illegal to defraud private health plans

How have public health laws delegated authority to specific government agencies?

-Require vaccination for certain diseases; -Require healthcare providers to report diseases; -Investigate outbreaks of communicable diseases; -Isolate or quarantine individuals who are infected.

How does health regulation promote access to care and efficiency?

-Requirements to provide emergency care (regardless of the ability to pay) -Regulatory controls on new healthcare facilities, equipment, and services, such as certificate of need (CON) laws -Antitrust laws to protect consumers and the competitive market -Regulation of health insurance companies and insurance plans

Written financial assistance policy (FAP)

-Statutory requirement to have a written policy about emergency care under EMTALA -The proposed rules do not establish eligibility criteria or obligations for free care -Eligibility criteria for assistance -Basis for calculation of charges -How to apply for assistance -Actions that might be taken for non-payment (unless set forth in a separate policy) -Methods that will be used to widely publicize the FAP - Easily available in plain language

Define "Breach of Duty"

-The plaintiff must prove that the doctor failed to meet the standard of care in diagnosing or treating the patient. - Can result in battle of the experts

Define "Causation"

-The plaintiff must prove that the doctor's breach of duty was the cause of the injury. -If the same injury or death would have occurred anyway, the plaintiff cannot prove the element of "causation."

Name four goals that health regulation can be used to achieve?

-To prevent disease and handle public health emergencies -To protect the safety of food, water, and the environment -To promote the quality of healthcare services and protect the rights of patients -To promote access to care and efficiency in the healthcare system

What financial incentives in Medicare has the federal government prohibited?

-To protect the interests of beneficiaries, the federal government has prohibited hospitals from giving financial incentives to physicians to encourage them to discharge patients more quickly or order fewer tests and treatments. -Gainsharing (a federal statute that prohibits hospitals from paying physicians to reduce the level of services for Medicare and Medicaid patients) may be allowed under limited circumstances

Limitations on charges for EMTALA

-amounts charged for emergency or other medically necessary care provided to individuals eligible for assistance under the financial assistance policy should not more be than the lowest amounts charged to individuals who have insurance covering such care (pay the same rate) -These requirements are intended to fix the problem of charging uninsured individuals more than the rates for groups of insured patients that receive volume discounts.

How are healthcare facilities subject to government regulation and self-regulation?

-government regulation in the form of state licensure -government supervision as participants in federal payment programs -industry self-regulation by means of voluntary accreditation

THE COBRA ANTIDUMPING LAW (EMTALA)

-hospital -that has an emergency department -participates in the Medicare program - applies to ALL patients

Advantages of no-fault system

-more fair because it compensates more injured patients. -more efficient because it handles disputes in less time and at lower cost. -less antagonistic because the patient does not need to prove negligence. BUT has to prove causation -has the potential to improve patient safety and quality of care because more data will be collected, and because no-fault could help to change the culture of medicine.

Community health needs assessment (CHNA)

-must consider "input from persons who represent the broad interests of the community served by the hospital facility, including those with special knowledge of or expertise in public health." -CHNAs must be "made widely available to the public." -The CHNA must be conducted at least every 3 years. -The hospital must also adopt "an implementation strategy" to meet the identified needs.

Define the Health Information Technology for Economic and Clinical Health (HITECH) Act

-notifying patients when their privacy has been breached; and -expanding the right of patients to receive an "accounting of disclosures" of certain health information in electronic form.

Goals of CHNA

-preserve hospital facilities' flexibility -particular health needs of the specific communities they serve -transparent assessment process with ample opportunity for community input

What are "Small-scale" reforms?

-reducing the statute of limitations to file a claim; -eliminating joint-and-several liability; -changing the "collateral source" rule; and -putting a "cap" (a maximum limit) on damages.

Name the 3 common cost containment techniques?

-selective contracting with healthcare providers -financial incentives to reduce the cost of care -mechanisms to control utilization of services

Give specific examples of how society governs individuals' treatment

-state governments have authority to require people to be vaccinated against communicable diseases -Also, federal law prohibits people from selling one of their kidneys -- affects interstate commerce

anti-abuse rule for EMTALA

A hospital facility will not have made reasonable efforts to determine whether an individual is FAP-eligible if the hospital facility bases a determination that the individual is not FAP-eligible on information the hospital facility has reason to believe is unreliable or incorrect or on information obtained from the individual under duress or through the use of coercive practices

Tarasoff v. Regents of the University of California

A student named Prosenjit Poddar told his psychologist at UC-Berkeley that he planned to kill Tatiana Tarasoff, who rejected him. The psychologist called the campus police about Poddar, but the police released him.The psychologist did not warn Tatiana. Two months later, Poddar killed Tatiana. Tatiana's parents argued that the psychologist had a duty to warn Tatiana.However, Tatiana was not his patient. Moreover, warning Tatiana about Poddar's intentions would have resulted in a breach of Poddar's medical privacy. Yet, the California Supreme Court held that therapists have a duty to warn

What is a waiver for state innovation used for?

ACA provides that a state may opt-out of the ACA's system for expanding coverage, if the state adopts its own system to achieve universal coverage. States may apply to the federal government for a 5-year waiver of particular ACA requirements.

Define Hedonism

Actions are right if they result in the greatest good for the only person who really matters--me.

Define Utilitarianism

An action is right if, and only if, it results in the greatest good for the greatest number of people. -identify those who would be helped and harmed and also consider the degree to which some people would be helped and the degree to which some people would be harmed.

Certification

An exercise of the government's power as a buyer (rather than its power as a regulator). -voluntary, professional self-regulation.

Describe the buffet approach

Arras, Steinbock, & London think ethical theories are not "mutually exclusive"

How are individual practitioners subject to professional self-regulation?

By means of specialty board certification and also in the credentialing process (for medical staff membership and clinical privileges).

Section 9007 of the ACA added 4 requirements for tax-exempt hospitals

Community health needs assessment Written financial assistance policy Limitations on charges Limitations on billing and collection

How does Congress' exercise it's conditional spending power on Medicare?

Congress offered to provide federal financial participation (FFP) to any state that agreed to establish a state medical assistance program which meets federal standards. -Congress may impose conditions on use of specific federal funds, but not conditions relating to other federal funds.

Self-referral

Doctors have financial incentives to refer patients to facilities that they own. -Self-referral can increase program costs and interfere with a doctor's independent judgment.

The tort of negligence requires proof of four elements

Duty Breach of duty Causation Damages

Define Coming to the Emergency Department for EMTALA

EMTALA applies to patients on the premises of the hospital -EMTALA does not apply to persons already admitted as inpatients or in an unemergency state

Ostensible agent

Even if a physician is not actually an employee or agent of the organization, a court might hold the organization vicariously liable under the doctrine of ostensible agency.

Is state or federal government in charge of regulating Medicaid reimbursement rates?

Federal, When California tried to reduce some Medicaid rates, providers and beneficiaries sued state officials.Plaintiffs (providers and beneficiaries) argued that the state Medicaid law (which reduced payment rates) was in conflict with the federal Medicaid law (which required sufficient payment rates).The U.S. Court of Appeals for the 9th Circuit agreed with plaintiffs and stopped the state from reducing rates. - BUT the U.S. Supreme Court did not decide the legal issue of whether providers or beneficiaries may sue state officials under the Supremacy Clause to enforce the federal Medicaid law. In the absence of a statutory right to enforce a federal law, private parties may not enforce it under the Supremacy Clause. Private parties already have the right to pursue administrative appeals and judicial review against CMS, regarding CMS' approval of reduced state Medicaid rates.

Define Feminist ethics

Feminist ethics is not a single theory, but rather a general approach of considering the effect of actions on the interests of women.

What did CMS and OIG established waivers for?

For ACOs since healthcare providers share financial resources, in ways that might violate existing laws about fraud and abuse. This is why they have established waivers for existing laws under specific conditions. -The ACO waivers apply to four specific laws about fraud and abuse. -CMS and OIG have established five separate ACO waivers from application of those laws.

Accountable Care Organizations

Groups of healthcare providers deliver quality care to Medicare patients in a coordinated manner, and share the cost savings resulting from those efforts. -Might violate existing laws about fraud and abuse, antitrust law, and tax-exempt status. -Federal agencies other than CMS (Center of Medicare Medicaid) have issued guidance about various legal issues in ACO participation.

Inspection

Health laws can authorize public health agencies to inspect goods (such as food) and places (such as restaurants and farms), in order to protect health and safety.

How has selective contracting increased competition?

Healthcare providers may compete to be preferred providers. Payers have bargaining power to exact substantial discounts from providers. Bidding for preferred provider contracts has increased the level of competition (but raises significant issues for patients and for providers who are excluded).

Why is it easier for the government to prove a civil case under the False Claims Act (FCA)?

In a civil case under the FCA, the government does not have to prove the provider "knowingly and willfully" made a false statement. -Government only needs to prove that the provider acted "knowingly", and that broad term includes: actual knowledge, deliberate ignorance, or reckless disregard of the truth.

Licensing

In order to conduct certain businesses (such as the sale of food), health laws can require a business to obtain a license (and pay a license fee), and the business must continue to meet safety standards -The purpose of licensure is to promote the quality of care (by making sure that every practitioner who provides healthcare services is fully qualified). -Under the police power of the state- mandatory

What is the effect of making malpractice a political issue?

Instead of relying on valid data, many governments adopted laws which were designed to further partisan agendas and advance the financial interests of stakeholder groups.

ACA's penalty is or is not a tax for purposes of the Anti-Injunction Act?

Is not; The Court held the ACA penalty is a tax for purposes of analyzing the constitutional power of Congress (tax and penalty mean the same). But, the Court held the ACA penalty is not a tax for purposes of determining the jurisdiction of the Court, under a statute known as the Anti-Injunction Act. (tax and penalty do not mean the same).

How does the ACA allow selective contracting with some protections for patients?

It indicates that health plans may continue to distinguish between "participating" and "nonparticipating" providers (and individuals only have a right to free choice among PCPs who are both "participating" and "available"). -Provide some rights for individuals needing emergency services -Parents who want to designate a pediatrician as PCP for a child -Women who want direct access to OB/GYN care without authorization or referral

What is a statewide health planning process?

It involves conducting an inventory of existing facilities and services in each geographic area of the state (and determining the future need for each type of facility and service). It is then followed by a review of specific CON applications.

Anti-Kickback statute

Makes it a felony to knowingly and willfully give or receive anything of value to influence someone to refer a patient covered by Medicare or purchase something for which Medicare may pay. -It applies to both the person who offers or pays the remuneration and the person who requests or receives it. -Paying for referrals could increase Medicare and Medicaid costs.

Can private employer-sponsored ERISA plans be sued under the laws of a state for wrongful denial of benefits?

NO, Private employer-sponsored ERISA plans cannot be sued under the laws of a state for wrongful denial of benefits. The only legal remedy for an employee or dependent is to sue the health plan under ERISA.

Can any physician be in a payer's provider network?

No you have to apply. Even after then MCOs and other payers do not have a legal obligation to accept every physician who applies for membership in their provider network.

Are CON laws limited to public facilities or government payment programs?

No, CON laws are not limited to services that are provided to Medicare or Medicaid patients. -It applies to private and public facilities, and they apply to services provided to commercially insured and self-paying patients (as well as publicly insured patients). -But, CON regulation does not require government approval for the continued operation of existing facilities, equipment, and services.

What is the sustainable growth rate? Do we use it today?

No, because the formula would required significant reductions in Medicare payments to physicians. It uses specific economic criteria to raise or lower Medicare payments to physicians. Yet congress stops these reductions and pretends that each delay is temporary. Congress is unwilling to repeal the SGR, because that would require recognizing the severe budgetary impact.

Is the individual mandate a regulation of interstate commerce?

No, if the federal government could require people to buy health insurance, it could also require people to buy broccoli.

Are the cost containment techniques of managed care limited to HMOs?

No, many insurance companies, health plans, managed care organizations (MCOs), and even government payment programs use them.

Is the ACA limited to providing coverage for the uninsured?

No, the ACA also requires insurance companies and plans to provide specific benefits (including preventive care with no copayment from the patient). The ACA also lets parents cover children until age 26 and improves the Medicare program.

Define Kantain ethics

Non-consequentialism; the ends (the favorable consequences) do not justify the means, (the immoral action). All people must be treated as ends in themselves - not merely as means to an end.

Define Consequentialism

Only the consequences of an action that make it right or wrong. Some people think that morality depends only on the results of the action. Consequentialism includes: Utilitarianism Hedonism

How does ERISA provides the exclusive remedy for participants in an ERISA plan?

Participant's claim under ERISA is the exclusive remedy against the ERISA plan. Any other remedy (such as a state law claim for bad-faith denial of benefits) is preempted by federal law. Thus, a participant in an ERISA plan may not recover damages in excess to their benefits under the plan (and may not recover punitive damages or compensation for pain and suffering).

Define selective contracting

Payers make contracts with providers that are willing to grant discounts and agree to the payer's utilization review procedures. By reducing their prices and becoming "preferred providers" for specific payers, physicians and healthcare facilities can increase their market share.

Define Principlism

People have certain moral duties. These moral duties may include beneficence (helping people), nonmaleficence (not harming people), honesty, justice or fairness, and respect for individual autonomy. They are called prima facie moral duties, because they seem to apply "at first view."

State authority to promote public health and regulate healthcare providers is based on

Police power

Title VI of the Civil Rights Act (CRA) of 1964

Prohibits discrimination on the basis of race, color, or national origin by any program or activity that receives federal financial assistance (FFA) -Applies to languages too -Also disabilities

Hyde Amendment

Prohibits use of federal (use of Medicaid) funds for abortion, except in some cases.

State Children's Health Insurance Program (SCHIP)

Provides health coverage to children in families with incomes too high to qualify for Medicaid, but can't afford private coverage.

Define Non-consequentialism

Right and wrong do not depend entirely on the consequences or results of the action. Non-consequentialism includes: Kantian ethics Principlism

Legal framework for abortion

Roe v. Wade and Casey -Constitution protects a woman's right to make her own decision about abortion before viability. -Therefore, a state government may not prohibit abortion before the point of viability. -However, after the point of viability, a state may prohibit abortion, except when it is necessary to preserve the life or health of the mother. -A state may prohibit abortion after viability even if the pregnancy was the result of rape.

Professional self-regulation

Self-regulation has the advantage of professional expertise in developing the standards and evaluating quality (but might have the disadvantage of self-protection). Example: -Peer review of doctors by other doctors -Accreditation of hospitals by a non-governmental organization (such as The Joint Commission or JCI)

Certificate of need (CON) laws

Some U.S. states impose regulatory barriers to market entry (for new facilities, equipment, and services). -In most states, government officials have the power to decide which new facilities may be built and which new services may be provided by each facility. -More than 30 states still have some CON requirements.

Define Ethical relativism

Some people argue that morality only exists in the context of a particular culture. It depends entirely on the culture's practices and values.

How is Stark different from the Anti-Kickback statute?

Stark law is based on structure of transaction, while anti-kickback is based on intent. Both are federal laws.

If a payer's denial of authorization or payment caused the death of a patient, the patient's estate might try to sue the payer and seek damages to compensate the survivors for their loss. In the past, insurance companies were tempted to deny and delay the payment of claims because there were no penalties. But now it is solved by...?

State courts and legislatures developed legal remedies against insurance companies (such as state law claims for bad-faith denial of benefits), that allow recovery of damages exceeding the amount of benefits under the policy. These state laws provide strong incentives for insurance plans.

Regulating the business of insurance is a traditional state or federal function?

State, they make sure that insurance companies are solvent and financially responsible. They can also protect consumers by regulating the rates, contract terms, marketing, disclosures, and claims practices of insurance companies. -But subject to federal regulatory power due to interstate commerce. -if laws specifically relate to the business of insurance OR -if those laws are consistent with state policies and regulation

Corporate negligence

Such as the hospital's duty to exercise reasonable care in permitting physicians to treat patients at that hospital

Define Gainsharing CMP

The Civil Monetary Penalties (CMP) Law which prohibits hospitals from paying physicians to limit or reduce services to Medicare or Medicaid patients

Define Beneficiary Inducements CMP

The Civil Monetary Penalties (CMP) Law which prohibits offering or giving something of value to Medicare or Medicaid patients that would influence their choice of provider.

Issues of care at the end of life will be governed by the laws of.. ?

The individual states. However, federal law plays a role in these issues.

Where does the Stark law apply?

The law applies if a doctor (or an immediate family member of a doctor) has: -an ownership interest in an entity OR -a compensation arrangement with an entity If so, the doctor may not refer patients to that entity. And, the entity may not bill Medicare or Medicaid for services resulting from that prohibited referral.

The Federal Ethics in Patient Referrals Act -Stark Law

The law makes some physician ownership impractical, by prohibiting certain referrals and the resulting reimbursement.

What is the main problem with kickbacks?

The main legal issue is the intent in giving or receiving the payment, but sometimes it is obvious that the intent of the parties was to pay for past referrals and encourage future referrals.

Define "Damages"

The plaintiff must prove that the patient suffered damages - economic loss and uneconomic loss

Doctrine of informed consent

The right of informed consent is more than just the right to be fully informed-- it is the right to consent or, more importantly, the right to refuse to give one's consent.

Explain the importance of Antitrust laws and provide examples

To protect consumers and protect the competitive market, antitrust laws prohibit practices that reduce competition (in healthcare as well as in other industries). Those unlawful practices include: -price-fixing; -boycotts; -market allocation; and -some mergers and acquisitions.

Vicarious liability (respondeat superior)

Under a legal doctrine known as respondeat superior, organizations may be held vicariously liable for the negligent acts of their employees or agents who are acting within the scope of their employment

How might one resolve benefit disputes from ERISA without litigation?

Upstream approach-federal rules only apply to internal review-of-benefit decisions within the plan, and do not impose any requirement for independent, external review. But some state governments enacted laws that require external review of benefit denials but a problem existed in attempting to apply those state laws to self-insured ERISA plans. -The ACA imposes a requirement for independent, external review. The specific requirements will depend on whether a particular health plan is subject to a state law that mandates an adequate process of binding external review.

The physician-patient relationship is based on a what type of contract

Voluntary

Accreditation

Voluntary process of industry self-regulation

Are hospitals responsible for outside debt collectors?

Yes, If an ECA was performed by a collection agency to which the hospital sold or referred the debt, the hospital is deemed to have performed that ECA.

Do ERISA only apply to private employer-sponsored health plans?

Yes, It does not apply to health plans for state and local government employees or insurance coverage in the individual market. -The legal rights of patients and their survivors will depend on the fortuitous circumstance of where the patient happened to obtain health insurance coverage.

Can a preferred provider contract permit termination with or without cause?

Yes, by either party. -In a termination "for cause," one party may terminate the contract as a result of the other party's failure to perform its obligations. -A provision for termination "without cause" allows either party to terminate the contract by merely giving sufficient notice in advance to the other party. - BUT some state courts have held that MCOs may not use termination "without cause" for an improper purpose because that would violate the public policy of the state.

Can insurance exchanges be operated by state and federal government?

Yes, individuals may buy health insurance and federal government subsidies are available on the basis of income. Each state may choose to operate its own exchange, partner with the federal government, or let the federal government operate it alone. -The federal Internal Revenue Service (IRS) takes the position that federal subsidies are available in a federally-operated exchange.

Is it illegal to give or receive a payment if any part of the motivation was to induce referrals?

Yes, the law states that it does not matter if the primary motivation was appropriate. If any part of the motivation was to induce referrals, the payment was unlawful. -We should make it unlawful if the primary purpose was to induce referrals, but that is very difficult to determine. Business arrangements with referral sources may be motivated by multiple factors. -This legal standard has created anxiety and uncertainty for the healthcare industry.

Originally, Stark only applied to ___________, but now also applies to many types of "designated health services" including radiology, PT, OT, home health, and hospital services.

clinical lab services

U.S. Supreme Court held that the individual mandate to buy health insurance is not a valid regulation of ___________, but the penalty for failure to do so is valid under Congress' power to ___.

interstate commerce; tax

PPS and managed care create incentives to provide ___ care in some cases.

less

Federal law also prohibits hospitals from giving doctors incentives to ____ or ____ services for Medicare or Medicaid patients.

limit or reduce; also known as Gainsharing CMP

The federal Anti-Kickback statute deals with financial incentives to provide ___ care and ____.

more, referrals

Pay-for-performance model has who in mind?

payers, not patients

In the past, UR primarily involved ____ review of services that already had been rendered. But, payers now use _____ UR to authorize or refuse to authorize proposed treatments, referrals, and hospital admissions.

retrospective, prospective; UR was primarily a vehicle that addressed the issue of money (rather than access to care).

A claim for lack of informed consent is based on what?

the law of negligence -In a claim for lack of informed consent, however, a plaintiff is not required to prove that the diagnosis or treatment was performed in a negligent manner (as is required in other negligence cases).