Basic Sources of Law: US Constitution

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Questions and Answers

Which of the following is NOT a basic source of law in the United States?

  • Court Decisions
  • International Treaties (correct)
  • Administrative Agency Regulations
  • Statutes

The Necessary and Proper Clause grants Congress the power to:

  • Enact legislation necessary and proper to execute its express powers. (correct)
  • Impose taxes without any limitations.
  • Override state laws on any matter.
  • Enact any legislation they deem appropriate.

Which statement accurately describes the relationship between federal and state law?

  • State law and federal law are equal; neither has supremacy.
  • State law supersedes federal law in all matters related to health.
  • Federal law always supersedes state law, regardless of the issue.
  • Federal law supersedes state law only when the federal law is constitutional. (correct)

Which of the following is characteristic of administrative agencies?

<p>They are executive bodies with quasi-judicial and quasi-legislative roles. (D)</p> Signup and view all the answers

Which branch of government is primarily responsible for enforcing laws?

<p>Executive Branch (A)</p> Signup and view all the answers

What role do committees play in the legislative process?

<p>They investigate and hold hearings on proposed legislation. (C)</p> Signup and view all the answers

What is the main function of the judicial branch?

<p>Interpreting laws and adjudicating disputes. (B)</p> Signup and view all the answers

What is 'judicial review'?

<p>The court's power to review actions of other government branches. (B)</p> Signup and view all the answers

In what circumstance can a federal court strike down a statute?

<p>If the statute is deemed unconstitutional. (C)</p> Signup and view all the answers

Which of the following describes 'judicial activism'?

<p>Courts interpreting the law in a way that some say makes new law. (A)</p> Signup and view all the answers

What is the usual remedy in a civil law case?

<p>Monetary damages (A)</p> Signup and view all the answers

What is the standard of proof in a civil case?

<p>Preponderance of the evidence (C)</p> Signup and view all the answers

What is the role of state constitutions?

<p>To organize the state government and grant and limit powers. (A)</p> Signup and view all the answers

What is the main function of a state appellate court?

<p>To hear appeals from lower courts. (A)</p> Signup and view all the answers

What is a 'writ of certiorari'?

<p>A request for a higher court to hear a case. (B)</p> Signup and view all the answers

Generally, how do employees receive healthcare coverage?

<p>Primarily through employer benefits and individual purchases. (D)</p> Signup and view all the answers

What is the main purpose of the Employee Retirement Income Security Act (ERISA)?

<p>To regulate employer-provided health and retirement plans. (D)</p> Signup and view all the answers

What is the purpose of the Consolidated Omnibus Budget Reconciliation Act (COBRA)?

<p>To allow continuation of health coverage after job loss or other qualifying event. (A)</p> Signup and view all the answers

What is the general focus of Stark Law?

<p>Preventing physician self-referral. (D)</p> Signup and view all the answers

How does the Anti-Kickback Statute differ from the Stark Law?

<p>The Anti-Kickback Statute requires intent, while Stark Law is a strict liability statute. (C)</p> Signup and view all the answers

What is the main purpose of the False Claims Act?

<p>To combat fraud against the federal government. (C)</p> Signup and view all the answers

What is the Hatch-Waxman Act primarily designed to do?

<p>Promote pharmaceutical innovation and generic drug availability. (B)</p> Signup and view all the answers

What is the central goal of RICO (Racketeer Influenced and Corrupt Organizations Act)?

<p>To combat organized crime. (C)</p> Signup and view all the answers

What is the central issue in Altman's conundrum regarding healthcare?

<p>Political deadlock on how to reduce the number of uninsured (C)</p> Signup and view all the answers

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Flashcards

U.S. Constitution

The constitution is the supreme law of the land that establishes government organization, grants power, and places limits on government.

Statutes

These are laws enacted by a legislative body such as Congress, state legislatures, or local legislatures.

Administrative Agencies

These agencies hold quasi-judicial and quasi-legislative roles. Examples include CMS, FDA, and NLRB.

Court Decisions

Interpret statutes/regulations, determine their validity, and create common law when deciding cases.

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Legislative Branch

Enacts new laws or amends existing ones. Process involves bill introduction, committee review, debate, and voting.

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Executive Branch

Enforces and administers laws. The federal chief executive is the President, and at the state level, it's the Governor.

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Judicial Branch

Interprets the laws and adjudicates disputes in accordance with the law. Includes medical malpractice cases.

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Checks and Balances

Each branch can affect and limit the functions of others through checks and balances, ensuring no single branch is dominant.

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Civil Law

Involves disputes between private parties or regulatory agencies and private individuals.

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Criminal Law

Applies to individuals and corporations, usually involving penalties like jail time, fines, or loss of license.

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Trial Court

Determines the applicable law and assesses evidence to determine the facts of a case.

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Appellate Court

Hears appeals from trial courts and other lower courts. Can affirm, reverse, or modify decisions.

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Supreme Court

Ultimate and final appeals court which decides appeals and has the right to decline review.

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Employee Benefit

Coverage subsidized by federal and state tax benefits for employer-provided health care coverage.

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Self-Insured/Uninsured

Provides coverage despite lack of employer-sponsored plans, often through COBRA or PPACA.

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The Government

Government-funded healthcare coverage, primarily through Medicare and Medicaid.

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Medicare

Government health insurance program established in 1965, providing coverage for those over 65 and some disabled individuals.

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Medicaid

Largest single insurer in the U.S., jointly funded by the federal and state governments, providing healthcare to low-income individuals.

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COBRA

Requires group health plans to provide temporary continuation of coverage that might otherwise be terminated.

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Fraud and Abuse

Designed to combat healthcare fraud and abuse through penalties and enforcement.

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Stark Law

Enforced self-referral statute prohibiting physicians from referring Medicare patients to entities where they have a financial interest.

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Anti-Kickback Statute

Prohibits offering remuneration in return for referrals of Medicare patients.

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False Claims Act

A civil and criminal statute that penalizes knowingly submitting false or fraudulent claims to the government.

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Product Hopping

A company creates minor changes to a drug to extend their patent life.

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RICO

Requires proof of an enterprise's conduct through a pattern of racketeering activity, distinct from the named defendant.

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Study Notes

  • The exam is 35% of the semester grade and will likely take two hours
  • Exam is 50% True/False, Multiple Choice, Short Answer Questions (complete sentences not necessary)
  • 50% Subjective Essays
  • Essays will address:
  • Constitutionality of the mandatory coverage provision of the ACA
  • Long fact patterns

Basic Sources of Law

  • There are four basic sources of law and their differences.

Constitutions

  • US Constitution is the Supreme Law of the Land
  • Constitutions grant power from the states to the federal government
  • They establish general organization and place limits on what state and federal governments may do
  • Powers are: Expressed, Taxation, declaration of war, and regulation of interstate commerce
  • Implied powers includes the Necessary and Proper Clause
  • Congress may enact legislation that is necessary and proper in its exercise of express powers
  • Federal law always beats state law so long as it is constitutional
  • Limitations on powers appear throughout the Bill of Rights
  • Every state has a constitution, organises their state government, grants and places limits on powers

Statutes

  • Law that is enacted by a legislative body such as:
  • Congress
  • State Legislatures (can be very powerful)
  • Local Legislatures (less powerful)
  • Federal law supersedes state, and state supersedes local statutes

Decision and Rules of Administrative Agencies

  • Administrative agencies are complex and are executive bodies that hold quasi-judicial and quasi-legislative roles
  • Examples of Agencies:
  • CMS: Centers for Medicare and Medicaid Services
  • FDA: Food and Drug Administration
  • NRLB: National Labor Relations Board

Court Decisions

  • Courts resolve disputes and interpret statutes/regulations
  • Courts determine whether statutes or regulations are permitted
  • Courts create common law when deciding cases not controlled by statutes/regulations/constitutions

3 Branches of Government

Legislative Branch

  • Makes the laws (enact new, amend existing).
  • Process:
  • A member of Congress introduces a bill
  • Legislatures generally assign legislative proposals to committees charged with oversight of the areas addressed by the proposals
  • Committees investigate and hold hearings at which interested persons may present their views
  • The bill is released to the full legislative body for consideration and debate, and a vote occurs
  • The bill must pass through the other chamber in identical form before it can be presented to the Chief Executive

Executive Branch

  • Enforces and administers the laws
  • The federal chief executive is the President
  • State level: Governor
  • The chief plays a role in the creation of law
  • Has the power to approve or veto bills passed by the legislature
  • Departments are assigned responsibility for specific areas of public affairs and enforces laws within their assigned area
  • Federal level: Department of Health and Human Services
  • State level: Department of Health

Judicial Branch

  • Interprets the laws and Adjudicates (decides disputes in accordance with the law)
  • Judicial process applies the law to suits
  • Example in healthcare: medical malpractice
  • Suing occurs to protect legally protected interests
  • Challenging acts by governmental agencies, initiating suit to have a law declared invalid, initiating suit to collect on unpaid bills, or initiating suit to enforce a contract
  • Overlap between the branches can cause tension and problems, and gives rise to the system of checks and balances
  • Separation of powers doctrine/checks and balances. No branch of government is dominant over the other two
  • Each branch may affect and limit the functions of others through their own powers, this is called checks and balances
  • In enacting legislation, statutes are enacted by Congress
  • Until signed by the President or passed over the President's veto by a 2/3 vote of each house of Congress, the bill does not become law
  • Executive veto: can temporarily (and possibly permanently) prevent a bill from becoming a law
  • Judiciary rules on the constitutionality of the law
  • The judicial branch can declare a law invalid if it decides that the law violates the US Constitution
  • In Judicial nomination, the president nominates federal judges and the Senate must confirm each nominee
  • In judicial review and interpretation, judicial review is the power of the court to review the actions of other branches or levels of government (implied in Article III of the Constitution)
  • The unconstitutionality of law is the only ground for the federal court to strike down a statute
  • Judicial interpretation is the power of the courts to interpret the law
  • Judicial activism: courts are accused of taking it too far and making new law through their interpretation of statutes
  • When they take it too far, the legislature steps in and responds by passing a new, amended law
  • Judicial lethargy is the opposite of judicial activism
  • Judicial restraint: strived for middle ground

Civil vs. Criminal Law

Civil Law

  • Disputes between private parties (the plaintiff brings the suit and the defendant is sued)
  • Disputes between regulatory agencies and private individuals
  • Penalties: money damages are most common
  • Compensatory (economic) include medical bills and lost wages
  • Non-compensatory (non-economic) include pain and suffering and mental anguish
  • Punitive (punish, therefore deterring blameworthy conduct)
  • Specific performance
  • Licensure implications include loss or suspension

Criminal Law

  • Applicable to both individuals and corporations
  • Does not always mean jail time
  • NOT disputes between two private parties
  • Penalties can include:
  • Jail time
  • Fines
  • Loss of license
  • and Loss of operating privileges
  • Enforcement by The government, federal prosecutors, state prosecutors, and regulatory agencies
  • In healthcare, utilize criminal penalties and statutes to restructure the healthcare system (FCA, HIPAA, Anti-Kickback)
  • Civil burden of proof: More likely than not (Weighing the scales of justice)
  • Criminal burden of proof: Beyond a reasonable doubt
  • If the glove does not fit, you must acquit

Organization of Court Systems

  • More than 50 court systems in the US (every state, federal system, DC, PR & US territories)
  • 3 levels: Trial court, intermediate court of appeal, and Supreme Court/Ultimate Court of Appeal

Trial court Responsibilities

  • Determine the applicable law and assess evidence to determine the facts
  • Judge determines the law
  • Jury determines the facts
  • Judge instructs jury on the law, and the jury applies the law to the determined facts

State Court Systems

  • Divided into family, juvenile, probate, and small claims court, and State appellate courts
  • Intermediate appellate courts hear appeals from trial courts
  • Supreme or ultimate courts hear appeals from intermediate, and directly from trial court in certain cases
  • Highest appellate court has the right to decline review

Federal Courts

  • District Courts: Throughout the country
  • Cases must involve a federal question or must be disputed between citizens from different states
  • Circuit courts of appeal: Hear appeals from federal district courts
  • There are 13 of them and They often have the right to decline review
  • Supreme court: ULTIMATE ARBITER
  • Ultimate and final appeals court and Decides appeals from the circuit courts and highest state courts
  • Has the right to decline review
  • Requests to have a case heard are made by filing a writ of certiorari, and denial of the writ means the court declined to review
  • Courts do not reach all the same decisions
  • State courts apply different state laws, and federal courts may differ from district to district and circuit to circuit

3 Basic Sources of Healthcare Coverage

Employee Benefit

  • Encouraged by federal and state law, through federal tax subsidies
  • Employees can exclude the value of health care coverage from their reported income on their individual tax returns
  • Employers get to deduct the cost of providing health care coverage on their corporate tax returns
  • Main federal statute concerning employer-provided health care benefits: Employee Retirement Income Security Act (ERISA)

Self-Insured/Uninsured

  • Self Insurance is not cheap
  • 44 million uninsured in 2013, now the number hovers around 29 million
  • Major federal statutes governing Self-Insurance: COBRA (1985), HIPAA (1996)
  • COBRA: If people lose their insurance due to a “qualifying event”, that event triggers the right to get your health insurance through your employer for a set period of time
  • HIPAA contains several reforms to the sale and continued availability of individual health insurance plans
  • State response is uncompensated care pools requiring everyone to have insurance
  • Federal response is PPACA (Patient Protection and Affordable Care Act)

The Government

  • Medicare/Medicaid

How Payers Pay

  • Payment was traditionally indemnity-based, wherein a physician submitted a patient's bill to the insurer, and the insurer paid it on behalf of the patient
  • Late 80s/early 90s: switch to Managed Care Organizations
  • Problems: General sense of unease in terms of access and advocacy
  • Lack of funding (healthcare has traditionally be underfunded by the government) leads to a lack of coverage and Not enough affordable access to insurance

Medicare

  • Established through 1965 amendments to the social security act (Title VIII of the Act)
  • Government health insurance program administered at the federal level
  • NOT income related
  • Eligibility requirements:
  • People over 65 years with sufficient quarters of coverage under the Supplemental Security Income (SSI) program
  • Disabled individuals who have been receiving SSI benefits for at least 2 years (unless dx'd with ALS – then the waiting period is waived)
  • Persons dx'd with end stage renal disease
  • Providers Hospitals must sign an agreement with HHS and meet conditions of participation, where they Agree not to bill medicare patients except deductible and co-insurance payments as well as services not covered
  • Physicians are paid directly by medicare
  • They charge patients only allowable copayments and deductibles
  • Nonparticipating providers can bill patient, and Medicare will pay patient directly
  • Nonparticipating can only bill the Maximum Allowable Actual Charge (MAAC)

Payment Systems

  • Prospective Payment System: Based upon diagnostic related groups (DRGs) which are organized into major diagnostic categories (MDCs)
  • Hospitals receive one payment for the entire admission and No extra payment for longer stays or more procedures unless the patient becomes an outlier
  • Used for inpatient and outpatient stays, SNF, rehab hospitals, home health care
  • Fee schedules: Elaborate price list used to reimburse physician services and other services not bundled into PPS (Clinical lab tests Durable medical equipment, Prosthetics)
  • Medicare + Choice is Medicare's managed care system, where Medicare pays a set fee to managed care plans to provide care for medicare beneficiaries

Medicare PARTS

  • Part A: Hospital Insurance
  • Paid for through payroll taxes while working
  • Covers inpatient care in hospitals, skilled nursing facilities, home health care, hospice care, but Doesn't cover custodial or long term care
  • Part B: Medical Insurance
  • Paid for with a monthly premium
  • Reimburses provider 80% and beneficiary pays the rest
  • Covers physician services, PT, OT, some home health care, medically necessary supplies
  • Part C: Medicare Plus Choice
  • Combines A and B and is Provided by private insurance companies approved by Medicare
  • Costs lower, has extra benefits, and Avoids need for Medigap policy
  • Part D: Prescription Drug Coverage
  • Jan 1, 2006 and has a Monthly premium available to all beneficiaries but not required
  • Insurance is provided by private companies
  • Medicare does not cover lengthy hospital stays or long term nursing care
  • Appeals process for medicare decisions requires you must follow an administrative procedure and exhaust all your administrative remedies prior to filing a lawsuit
  • Medicare COSTS: Part A: $0 if covered by Medicare taxes. $506/month if not. $1600 deductible Part B: sliding scale $164.90/month – 560.50/month, and 10% per year late enrollment penalty for each year you choose not to take it once you qualify Part D: sliding scale (Plan premium - $76.40 plus plan premium, plan premium is roughly 32/month)

####Medicare PROBLEMS

  • We will SOON have more older persons than working age persons
  • Currently, there are 2.9 workers for each person with Medicare
  • Predicted that Medicare part A expenditures will SOON exceed payroll taxes

Medicaid

  • The largest single insurer in the United States in terms of beneficiaries enrolled and number of dollars spent
  • 82 million people and approximately 20% of health and is the largest insurer of children and people with disabilities
  • Largest provider of maternity care, largest single purchaser of prescription drugs, and largest financer of nursing home care
  • It's a Joint federal/state program, administered by states, under Title XIX of Social Security Act
  • States aren't required to have Medicaid, but all do and must pass their own laws to participate
  • Funded through grants to states – states must enroll all eligible people who apply in order to receive funding
  • Medicaid Counter-cyclical: expands when the economy contracts
  • Mann Article: includes Broad federal guidelines but mostly state-controlled
  • The government pays each state an FMAP – federal Medicaid assistant percentage – of at least 50%
  • DSH: Disproportionate Share Hospitals, treat a disproportionate amount of indigent patients and get larger state Medicaid payments
  • Medicaid Providers Institutional: • Contract with the state to provide services to Medicaid recipients in exchange for payment permitted by the State • Payment cannot be collected from the patient unless provided for by federal law Non-institutional: • Not required to enter contract w/ state and treats patients and bills the state

Medicaid Eligibility

  • State discretion. Must be low income (nonelderly adults at < 138% of the FPL)
  • ACA attempted to eliminate other categories required for enrollment, so now this is optional
  • Categorically needy: • Pregnant women and children under age 6 whose family income is at or below 138% of the Federal poverty level • Children aged 6 to 19 with family income up to 100% of the Federal poverty level • Caretakers under age 18 (19 if still in high school)
  • Medically needy: Those who have too much money to be eligible as “categorically needy"
  • States are not required to cover them
  • If they do, they must cover: Pregnant women, Children under 18, Blind persons
  • Special groups includes • Medicare beneficiaries whose income is at or below 100% of poverty level • Part A premiums for qualified working disabled individuals • Women who have breast or cervical Cancer
  • Persons with tuberculosis (TB)
  • Coverage is retroactive to any or all of the 3 months prior to application, if the applicant was otherwise eligible
  • Long Term Care: All states provide community Long Term Care services for individuals who are Medicaid-eligible and qualify for institutional care _ Mann article_ • Wide variation from state to state_ • "If you have seen one Medicaid program, you have seen one Medicaid program" • Unique brand of federalism”. Problems with medicade include: •“To serve or not to serve”- Tension between and among states, local government, providers and beneficiaries“Your money, my rules”- Tensions between states and the federal government
  • Life expectancy increases, increasing demands for LTC
  • A shortage of funds lead to Balance Budget Act of 1997 which Repealed the Boren Amendment
  • Amendment required states to find that reimbursement rates were reasonable and adequate to meet the costs which must be incurred by efficiently and economically operated facilities"
  • States choose not to simplify the renewal process b/c it would Increase enrollment and costs
  • State budget constraints deter eligibility and benefit improvements

State Children's Health Insurance Program_ (SCHIP):

  • _for children up to 19. Utilised by children whose parents have too much money to qualify for Medicaid, but not enough to by private insurance.

States encouraged to participate by higher matching federal payments_ Eligibility varies_

Centers for Medicare and Medicaid Services_(CMS):_

  • Largest purchaser of health care in the US.
  • 120 million beneficiaries
  • and annual budget over 1 trillion

CASES

  • Salgado et al. v. Kirschner et al where the Supreme Court of Arizona, with Judge En Banc/Federick J. Martone ruled in favor of Salgado. Arizona chose to participate in Medicaid meaning it must meet the basic requirements of care pursuant to Title XIX. _Elizabeth Salgado_was an eligible member of Arizona’s Medicaid program, suffering from a fatal, idiopathic liver disease (only effective medical treatment is liver transplantation, but Salgado waited for Medicaid approval, which was initially approved, but ultimately denied)

  • Reason for denial by Arizona Statute tried to limit coverage of transplantation to those persons under 21 years of age

  • Salgado challenged Medicaid, and exhausted her Administrative Remedies, eventually getting her life-saving transplant

  • Argued the statutory age classification violated the federal Medicaid statute and the equal protection clauses of the US and Arizona Constitutions The issue was whether the Federal law allows Arizona to deny lifesustaining transplant coverage to an otherwise eligible Medicaid recipient solely because she is over 21 years of age? The court held that "Similarly Situated" means all patients who could be treated effectively by the same organ transplant procedure

  • The "catchall" provision requiring certain services was not controlling because the federal statute addressed organ transplants and prohibited an arbitrary denial of this service to an otherwise eligible Medicaid recipient and "It is reasonable to expand service categories for age appropriate care to young persons. But it is unreasonable to allocate treatment within a service category solely on the basis of age."

  • Disposition:

  • Vacate the opinion of the court of appeals

  • Lower Court’s denial of coverage was reversed

  • Case was remanded to the Superior Court for an entry of judgment in favor of Salgado and Pima County on their claims for relief Aetna Health Inc. et al. v. Davila Cigna Healthcare v. Calad was an Appeal from 5th Cir. COA, with a Unanimous decision written by Justice Thomas and a Concurring opinion by Justice Ginsburg, joined by Justice Breyer The issue was: Whether the Respondent's causes of action fall “within the scope" of ERISA section 502(a)(1)(B) and/or section 502(a)(2) Holding: The respondents state causes of action fall "within the scope” of ERISA and are therefore completely pre-empted by ERISA Geissal v. Moore which was Appealed from the 8th Circuit COA. Unanimous decision written by Justice Souter. COA's judgment is vacated, and the case is remanded for further proceedings consistent with this case

THE EMPLOYEE RETIREMENT INCOME SECURITY ACT OF 1974 (ERISA)

  • _Pension law under the Nixon administration _Pro-employee and has a Uniform set of regulations that govern employee benefits across state borders

  • If an employer offers a benefit plan, the plan must be offered and maintained pursuant to a written instrument, and the plan must be controlled by one or more fiduciaries

  • Employer must be able to show you a written and maintained instrument Fiduciary has the beneficiary’s best interest at heart Loyalty is to the beneficiary, not the employer

  • Civil action may be brought by a participant or beneficiary , to recover benefits due to him under the terms of the plan, or to clarify his rights to future benefits under the terms of the plan

  • ERISA DOES NOT require an employer to offer any type of employee benefit

  • If an employer does offer any benefit covered by ERISA it provides for the federal regulation of the employer's benefit plans

  • An important feature is the pre-emption clause, where State laws shall supersede any and all state laws, insofar as they may now or hereafter relate to any employee benefit plan

  • ERISA Clarifies Congress's intention that states should not be passing laws relating to employee benefit plans

  • ERISA pre-emption is express pre-emption because it is specifically provided for by the statutory text (Implied pre-emption is when Congress has not directly spoke, and courts must decide whether state laws are pre-empted) Savings clause Nothing in this subchapter shall be construed to exempt or relieve any person from any law of any State which regulates insurance, banking, or securities” States can enact laws regarding insurance The general rule is that states CAN enact laws regulating insurance, but CANNOT laws relating to an employee benefit plan Employee benefit plan looks like insurance where plans are administered by insurance companies on behalf of employers on a contractual basis Approx. 50%-60% of individuals having health coverage have it through a self-insured plan

  • Deemer clause: where Neither an employee benefit plan... nor any trust established under such a plan, shall be deemed to be an insurance company or other insurer

  • cannot be deemed to insurance or insurance-related by a state legislature nor congress doesn't want states from getting around ERISA by deeming an employee benefit plan insurance COBRA: The Consolidated Omnibus Budget Reconciliation Act of 1986 Why?

There was a time when employer-provided group health coverage was at risk if an employee was fired, changed jobs, or got divorced_

Cobra amends ERISA, internal revenue code, and public health services act_

  • --Administration

Private sector: department of labor and treasury_ Public sector: HHS_

Cobra requires group health plans to provide a temporary continuation of coverage that might otherwise be terminated_ Employers must offer cobra benefits to qualified beneficiaries , or in other words employees, their spouses, their former spouses, and their dependent children_ Coverage is triggered by qualifying events such as Death of a covered employee, Termination, or A Child's loss of dependant status

  • Employer can require the individuals electing continuation coverage to pay the full cost of coverage, plus a 2% administrative charge. _Note that it's More expensive than the cost to active employees but still less than individual coverage
  • Cobra is applicable if All group health plans maintained by private sector employers with at least 20 employees, or maintained by state or local governments
  • There are exceptions in place: where Cobra does NOT apply to plans sponsored by the federal government, or by churches and certain church-related organizations and DOES NOT matter whether the plan is governed by ERISA (ie. whether it is employer self-insurance), but generally the plans are governed by ERISA

Termination

If Termination happens, The employer must give notice of the qualifying event to the plan before the health plan is required to offer continuation coverage (The employer has 30 days to give notice) Once a plan receives notice of a qualifying event, they must issue an election notice within 14 days, describing the beneficiaries' rights and how to make an election, beneficiaries are then given 60 days for the election Duration of coverage is that If qualifying event is termination of employment or reduction of hours, qualified beneficiaries are entitled to 18 months of continuation coverage If qualifying event is otherwise, qualified beneficiaries are entitled to 36 months of continuation coverage

Early termination

If termination happens early premiums aren't paid premiums timely and in full Employer ceases to maintain a group insurance plan which will require a plan to begin with in order to begin with Qualified COBRA beneficiary becomes eligible for Medicare benefits Qualified beneficiary engages in conduct that would justify the plan in terminating coverage of a similarly situated participant not receiving continuation coverage (or fraud) Disability extension can occur with the following criteria Determining coverage First, must ask, "is there a group health plan covered by COBRA?" then ask "did a qualifying event occur?" Lastly, ask "is there a qualifying beneficiary who can claim continuation coverage?" Answering yes to all three indicates cobra applies The American Recovery and Reinvestment Act of 2009 (no longer applicable) PPACA Extends dependent coverage to 26

Fraud and Abuse has been a shift in health care from inpatient to the outpatient setting with the additional need for physicians to augment their practices and causes a rise in joint ventures among health care providers

  • Structuring of these business arrangements presents a significant challenge to the businesses and the lawyers involved
  • Healthcare specific: licensure issues, CON issues, regulations, billing arrangements, fraud and abuse statutes

prosecution for Fraud and Abuse results in stiff penalties, usually heavy fines and enforcement by DOJ, CMS, OIG, all within the function of the executive branch.

  • Importance is in dealing with government money, huge expenditures plus it deters behavior

Stark is:

  • Enforced by the Centers for Medicare and Medicaid Services (CMS) and is a self-referral statute

  • Operates as a per se statute (meaning if you do it, you're liable, regardless of intent) but It is not criminal

  • Only triggered by the acts of a physician, or a physician's family member which Eliminates the incentive for physicians to over utilize Designated Healthcare Services

  • Prohibits physicians or their immediate family members from referring Medicare patients to an entity for certain “designated health services” including inpatient and outpatient hospital services, if the referring physician or immediate family member has a nonexempt “financial relationship” with such an entity and the payor involved is Medicare or Medicaid The "entity” cannot bill Medicare for services furnished to the referred patient, if that referral falls into the category of prohibited referrals under the statute forbids payment of Medicare Claims for services rendered in violation of its provisions and submitting the claim will imply violation of Stark and the False Claims Act There are specific Penalties listed, like Exclusion from participation in Medicaid and/or Medicare and civil and monetary penalties

Statuatory Violators

Avoiding violations with state's law, the key is being aware of statutory exceptions, and if they arise, staying compliant by: in referral Situations To other physicians within the same group In-office ancillary services and Within prepaid health plans Financial relationship Situational Rental of office space and equipment plus Bona fide compensation, and physician related recruitment Also requires, E-prescribing plus EHR The Group Practice 2 or more physicians legally organized as a partnership, professional corporation, foundation, etc with various regulatory considerations Must dedicate 75% of time to group business If your not sure, perform a strick anti kick-back analysis Does the arrangement involve a referral of a Medicare or Medicaid patient by a physician or immediate family member? Is the referral for a “designated health service"? Is there a financial relationship of any kind between the referring physician or a family member and the entity to which the referral is being made? Does the act fall within one of the designated “exceptions” to the Stark Law?" There are enforcements on "AntiKickback" where the key enforcement and regulation is by.

Enforcement Structure

Office of the Inspector General (OIG) The concern is that kickbacks cause over utilization, increase costs and result in unfair competitions adversely affects the quality of patient care by encouraging physicians to order services or recommend supplies and prescriptions based upon profit rather than the patient's best medical interests civil penalties for violation, as well, though, the The same action can cause the actor to violate both Stark and Anti-Kickback IF analysis is needed, one must, in analyzing the problem using a Stark Analysis, also continue the analysis using an Anti-Kickback analysis It essentially Prohibits the receipts of remortalities on behalf of medicare patients

Remuneration can be anything of value

False Claims Act Essentially, what is going on is that "persons” with Durable Medical Equipment Companies, Pharmaceutical, and Lab corporations will promise to pay the full amount, while the company will try to get as close to that amount as possible

Penalties can include any of these

Felony with up to a $25,000 fine Up to 5 years in prison, for both Additional monetary fine of up to $50,000 AND three times the amount of the illegal kickback To protect against this, there are certain Safe Harbors that Created by the OIG to provide certainty to health care providers on how to structure legitimate arrangements And If your activity comes within the purview of one of the “safe harbors”, you should not have a violation Criminal offense to knowingly or willingly offer to pay any remuneration to induce referrals of services used by the Federal Health Care programs Criminal liability to parties on both sides of the transaction for a violation

False Claims Act

  • Civil and Criminal with focus on civillian components
  • The act can be Prosecuted by the DOJ- responsibility to decide on behalf of the government whether to join the whistleblower in prosecuting the cases
  • Provides for penalties and triple damages for anyone who knowingly submits or causes the submission of false or fraudulent claims to the United States. Most important tool in combatting Medicare and Medicaid fraud and abuse “Modern FCA” includes civil cases regarding ☐ If one tries to apply for fraud, for Example they will • (1) Submit a false claim to the Government • (2) With "knowledge” of its falsity Most problems stem from these cases.

Fera: Fraud Enforcement and Recovery Act of 2009

  • Expands liability under the FCA for retention of an overpayment if done knowingly or improperly, or it is concealed.
  • Expanded the anti-retaliation provision to further protect the whistleblower
  • The act applies for presentment of false claims to a Medicare intermediary
  • Product Hopping Article: article dealing on the pharma industry with certain processes like patent regulations

Cases in the matter include

Mylan and Actavis

Terms

RICO, Anti-Kickback" or "fraud" but it Depends, so make sure you can fully explain on an exam what you are doing/looking at

RICO: Racketeer Influenced and Corrupt Organizations Act

Requires proof of conduct of an enterprise through a pattern of racketeering activity and requires evidence that a defendant, directly or indirectly, took some part in directing the enterprises affairs The "enterprise” must be distinctly identified from the named person defendant Enterprise: Legel entity (business, gov unit, etc Is provided through proof of evidence and is an ongoing ongoing organisation Is often fraud because those are easy to prove, etc

Altman's conudrum

Pauly article General consensus is to reduce the number of people uninsured but what they cannot agree on is how.

There can be agreements on groups from all angles, be it market, labor etc, just requires compromise in a fair way, and be fair by working toward middle ground compromise Conclusion: liberals should compromise and support vouchers as their second choice and Eliminating state laws should compromise In short, the ideal method should consider everyone and find middle ground (like Medicaid) ERISA IS there to protect employeers and employees against things like not covering expenses Davil and calad cases both help, but one may be more specific to your situation

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