You are here: Home Insurance The Affordable ... Summary
Information about all aspects of finances affected by a serious health condition. Includes income sources such as work, investments, and private and government disability programs, and expenses such as medical bills, and how to deal with financial problems.
Information about all aspects of health care from choosing a doctor and treatment, staying safe in a hospital, to end of life care. Includes how to obtain, choose and maximize health insurance policies.
Answers to your practical questions such as how to travel safely despite your health condition, how to avoid getting infected by a pet, and what to say or not say to an insurance company.

Summary

FOR ADDITIONAL INFORMATION ABOUT THE FOLLOWING SUBJECTS, SEE THE OTHER SECTIONS OF THIS ARTICLE

Through your employer:

  • You can keep your health insurance.
  • You cannot be discriminated against for participating in a clinical trial. Incidental medical costs will be covered.
  • Because of the Affordable Care Act::
    • Lifetime limits on coverage have been eliminated.
    • Insurers cannot cancel policies just because a policyholder gets sick.
    • Children are allowed to stay on a parent's policy until age 26.
    • If your plan includes coverage for children, coverage cannot be denied because of a child's pre-existing condition.
  • Starting in 2013, 
    • Flexible Spending Accounts will be limited to $2,500. Funds will no longer be able to be used for over-the-counter medications unless they are prescribed by a doctor.
    • Families making more than $250,000 (including unearned income) will pay more Medicare Part A payroll taxes.
  • Starting in 2014:
    • You will also have the choice to purchase coverage through a state-based Exchange.
    • All new plans must contain a minimum package of benefits, including preventive services such as immunizations. Patient costs relating to clinical trials must be covered.
    • Insurers will not be able to deny coverage or charge more because of a pre-existing health condition.
  • Starting in 2018, insurers will pay an excise tax on plans with high premiums. This may result in higher premiums or lower benefits.

On your own:

  • You can keep your health insurance.
  • You cannot be discriminated against for participating in a clinical trial. Incidental medical costs will be covered.
  • Starting September, 2010:
    • You have the choice to cover children up to age 26 on your policy
    • Insurers have to eliminate annual limits in coverage.
    • Insurers will not be able to cancel a policy just because a policyholder becomes sick.
  • Starting in 2013, families making more than $250,000 (including unearned income) will pay more in Medicare Part A payroll taxes.
  • Starting in 2014:
    • You will have the opportunity to purchase coverage through an Exchange
    • Your health plan must cover the incidental costs of participating in a clinical trial.
  • Young people are likely to face increases in premiums because the law limits charges to older adults to a maximum of three times what the company charges to young adults.

Through Medicare

  • Preventive care will be added to Medicare.
  • People with Medicare Part D (drug coverage):
    • Will get a $250 rebate in 2010 when they reach the dough nut hole.
    • Starting in 2011, pharmaceutical manufacturers must provide a discount  on brand -name drugs filled in the Medicare Part D "doughnut hole."  
    • Will see their co-pay go from 100% to 25% by 2020
  • Premium subsidies would be reduced for individuals making more than $85,000 or couples making more than $170,000.
  • Medicare Advantage:starting in 2011, premium subsidies will be reduced.  Some analysts believe that the likely effect will be higher premiums or decreased coverage.

Through Medicaid:

  • Until 2019, States are prohibited from cutting children from Medicaid or CHIP (Children's Health Insurance Program).
  • States must retain current eligibility requirements for adults until 2014. 
  • States are prohibited from terminating your Medicaid coverage until 2014 when the Exchanges start, unless the state forecasts a budget shortfall.

Premium And Cost-Sharing Subsidies For Individuals

For health insurance purchased through an Exchange:

Premium Credits: There are refundable and advance-able premium credits to eligible individuals and families with incomes between 133-400% of the Federal Poverty Level offsite linkto purchase insurance through the Exchanges.

The amount of the premium credits are:

  • Tied to the second-lowest cost silver plan offered by an Exchange in the area.
  • Set on a sliding scale.
  • Adjust each year to reflect changes in the consumer price index. offsite link

Cost Sharing subsidies: There are cost-sharing subsidies to eligible individuals and families. NOTE: If you receive a health subsidy, it is required that you file a form 8962 to your individual income tax return. Failure to file this form could result in making you ineligible for subsidies next year.

Premium Credits and Cost Sharing Subsidies and Abortion: Neither federal premium or cost-sharing subsidies can be used to purchase coverage for abortion beyond saving the life of the woman or in cases of rape or incest.

Eligibility:

  • Eligibility is limited to U.S. citizens and legal immigrants who meet income limits.
  • Employees who are offered coverage by an employer are not eligible for premium credits unless the employer plan does not meet minimum standards or if the employee share of the premium exceeds 9.5% of the employee's income.
  • Legal immigrants who are barred from enrolling in Medicaid during their first five years in the U.S. will be eligible for premium credits.

Temporary High-Risk Pools

Health Reform 2010 establishes a temporary national high-risk pool to provide health coverage to Individuals with pre-existing medical conditions starting the end of September 2010 until January 1, 2014.

U.S. citizens and legal immigrants who have a pre-existing medical condition and who have been uninsured for at least six months are eligible to enroll in the high-risk pool and receive subsidized premiums.

Premiums for the pool will be established for a standard population.

Maximum cost-sharing will be limited to $5,950/individual and $11,900/family in 2010.

NOTE: This feature is in addition to all other currently existing means of obtaining health insurance.

Medicare

The Affordable Care Act Improves Medicare Part D coverage (the drug benefit) by doing the following:

Doughnut hole: The beneficiary coinsurance rate in the doughnut hole for brand name drugs is gradually reduced over time from 100% to 25% by 2020. (At that point, cost sharing for both brand and generic prescription drugs will be the same during the “donut hole” as during the initial coverage period. Consequently, in 2020, individuals will pay 25 percent of drug costs, and the Part D plan will pay 75 percent. 

For a schedule of the reductions while the hole remains open, click here offsite link.

Brand-name drugs: The Act requires pharmaceutical manufacturers to provide a 50% discount on prescriptions filled in the Medicare Part D coverage gap (the so-called doughnut hole). This is in addition to federal subsidies of 25% of the brand-name drug cost by 2020 which is being phased in. 

Generic drugs:  The Act provides federal subsidies of 75% of the generic drug cost by 2020 for prescriptions filled in the Medicare Part D doughnut hole. The subsidies are being phased in.  

Preventive Services: Medicare recipients arel not charged co-pays or deductibles for basic preventive care such as immunizations.

Dual eligible beneficiaries (people who qualify for both Medicare and Medicaid):

  • The Act makes Medicare Part D cost-sharing for full-benefit dual eligible beneficiaries receiving home and community-based care services equal to the cost-sharing for those who receive institutional care. 
  • The Act aims to improve care coordination for people who are eligible for both Medicare and Medicaid by creating a new office in Centers for Medicare and Medicaid Services, known as the Federal Coordinated Health Care Office.

Catastrophic coverage: Between 2014 and 2019, the Act reduces the out-of-pocket amount that qualifies an enrollee for catastrophic coverage in Medicare Part D.

Income-related Medicare Part B premiums: The Act freezes the threshold for such premiums for 2011 through 2019 at 2009 levels.

Medicare Part D premium: The Act reduces the subsidy for people with incomes above $85,000/individual and $170,000/couple.

Personalization: The Act provides Medicare beneficiaries access to a comprehensive health risk assessment and creation of a personalized prevention plan. (The health risk assessment model is to be developed within 18 months following enactment).

Environmental Health Hazards: The Act expands Medicare coverage to individuals who have been exposed to environmental health hazards from living in an area subject to an emergency declaration made as of June 17, 2009 and have developed certain health conditions as a result. 

Medicare Advantage (MA) plans: For individuals making more than $85,000 or couples making more than $170,000, subsidies are being reduced.

Health Insurance Requirement (And Tax Penalty For Not Obtaining Health Insurance)

People who do not have coverage in 2014 are required to pay a tax penalty. The penalty is the greater of $695 per year up to a maximum of three times that amount ($2,085) per family or 2.5% of household income.

The penalty will be phased in according to the following schedule:

Year Amount of Penalty

2014 $95 or 1% of taxable income

2015 $325 or 2% of taxable income

2016 $695 or 2.5% of taxable income

Beginning after 2016, the penalty will be increased annually by the cost-of-living adjustment.

Exemptions are granted for:

  • Financial hardship
  • Religious objections
  • American Indians
  • People without coverage for less than three months
  • Undocumented immigrants
  • People in jail
  • People for whom the lowest cost plan option exceeds 8% of an individual’s income
  • People with incomes below the tax filing threshold (in 2009 the threshold for taxpayers under age 65 was $9,350 for singles and $18,700 for couples)

Exchanges

The Exchanges: Healthcare.gov offsite linkprovides access to the various state exchanges. ("American Health Benefit Exchanges and Small Business Health Options Program (SHOP) Exchanges").

Eligibility: Eligibility to purchase insurance from an Exchange is limited to:

  • U.S. citizens and legal immigrants who are not in prison.
  • Small businesses with less than 100 employees.
  • States will be permitted to allow businesses with more than 100 employees to purchase coverage from an Exchange beginning in 2017.

Policies Offered:

  • The Act creates 4 benefit categories of plans plus a separate catastrophic plan to be offered through the Exchange and in the individual and small group markets. The categories are: Bronze, Silver, Gold, Platinum and Catastrophic. The catastrophic plan is an alternative for:
    • People under 30 years of age
    • People who are exempt from the mandate to purchase coverage. 
  • The act reduced out-of-pocket expenses for people with incomes up to 400% of the Federal Poverty Level (FPL)
  • There must be at least two multi-state plans in each Exchange. At least one plan must be offered by a non-profit entity and at least one plan must not provide coverage for abortions beyond those permitted by federal law.

Guaranteed Issue and Renewability: The Act requires that policies issued through an Exchange for individuals and the small group market include guarantee issue and renewability. This means that even people with pre-existing health conditions are guaranteed to be able to purchase and renew a policy.

People with a health condition cannot be charged more because of their health condition. Rating variations are only allowed in the indiviudal market, small group market and the Exchanges for the following reasons:

  • Age (with a limitation on the maximum that can be charged)
  • Premium rating area
  • Family composition
  • Tobacco use

State health plans:  States are given the option to create a basic health plan for uninsured individuals with income between 133% and 200% of the Federal Poverty Level (FPL) instead of those individuals receiving premium subsidies to purchase coverage in the exchanges. States which choose to provide this coverage must provide at least the essential health benefits. To find out what is happening in your state, go to HealthCare.gov offsite link

Protections Concerning Health Insurance Policies

Guarantee Issue: Individual (in the market and in the Exchange) and small group market plans may not exclude coverage based on pre-existing conditions.

Waiting periods for coverage: Plans cannot include waiting periods for coverage to start of greater than 90 days.

Pre-existing health conditions for adults: Existing group, individual (in the market and in the Exchange) and small group market plans can no longer include pre-existing condition exclusions for adults. No new pre-existing coverage exclusions are allowed.

Dependent Coverage: The Act requires insurers to provide dependent coverage for children up to age 26 for all individual and group policies. This includes both new and existing policies.

Pre-Existing health conditions for children:

  • New plans are prohibited from including pre-existing condition exclusions for children.
  • Existing individual and group plans must eliminate pre-existing condition exclusions for children.

Annual Limits: New individual and group health plans are prohibited from placing annual limits on the dollar value of coverage. 

Lifetime Limits: Individual and group health plans are prohibited from placing lifetime limits on the dollar value of coverage. This limitation does not apply to existing individual policies. Group plans must eliminate lifetime limits on coverage.

Rescission: Insurers are prohibited from ending coverage except in cases of fraud. This limitation applies to existing individual and group plans.

Consumer Assistance: States must establish an office of health insurance consumer assistance or an ombudsman program to serve as an advocate for people with private coverage in the individual and small group markets. 

Appeals: For new plans, appeals are standardized, including a right to an independent, external review board. The appeals process will be available even when coverage is canceled.

Minimum Health Insurance Coverage The Act creates an essential minimum health benefits package that provides a comprehensive set of services and limits the annual cost-sharing. All health benefit plans, including plans offered through the Exchanges and plans offered in the individual and small group markets outside the Exchanges, must at least meet the essential health benefits package, except for grandfathered individual and employer-sponsored plans. ( "Grandfather" refers to existing policies issued before March 2010 which have not been changed substantially. They are being allowed to remain in force.)

Abortion coverage cannot be a required part of the essential health benefits package.

Clinical trials: Costs associated with clinical trials have to be covered. Policyholder cannot be discriminated against for being part of a clinical trial. (For more information, click here.

Standardized policies: All new policies (except stand-alone dental, vision, and long-term care insurance plans), including those offered through the Exchanges and those offered outside of the Exchanges, must comply with one of the four benefit categories. Existing individual and employer-sponsored plans do not have to meet the new benefit standards.

Limitation on Deductibles: Deductibles on health plans in the small group market are limited to $2,000 for individuals and $4,000 for families unless contributions are offered that offset deductible amounts above these limits.

Premium Rating: Individual (in the market and in the Exchanges) and small group market premiums are only allowed to vary based on:

  • Age (a maximum of 3 for older people to 1 for younger people)
  • Geographic area
  • Family composition
  • Tobacco use

Prevention: Qualified health plans are required to provide basic preventive coverage without cost-sharing.

Taxes

EFFECTIVE JULY 1, 2010

The Act imposes a tax of 10% on the amount paid for indoor tanning services.

EFFECTIVE JANUARY 1, 2013

Medical Deductions For Tax Purposes: Health Reform 2010:

  • Increases the threshold for deduction of unreimbursed medical expenses from 7.5% of adjusted gross income to 10% of adjusted gross income for regular tax purposes.
  • Waives the increase for individuals age 65 and older until tax year 2017. 

Medicare Part A: Health Reform 2010 increases the Medicare Part A (hospital insurance) tax rate on wages by 0.9% (from 1.45% to 2.35%) on earnings over $200,000 for individual taxpayers and $250,000 for married couples filing jointly

Unearned Income:  The Act imposes a 3.8% Medicare tax on unearned income individual taxpayers with adjusted gross income over $200,000 and married couples filing jointly with adjusted gross income over $250,000. This includes income from interest, dividends, capital gains, annuities, royalties and passive rental income. It does not include tax-exempt interest or retirement plan payouts. .

Medical Devices: The act imposes an excise tax of 2.3% on the sale of any taxable medical device.

Insurers of employer-sponsored health plans: The Act imposes a tax on insurers of certain high-value employer sponsored health plans.

Pharmaceutical Manufacturers and Health Insurance Companies:

  • Health Reform 2010 imposes new taxes to pay for health reform on the pharmaceutical manufacturing sector and the health insurance sector starting in 2012 and 2014 respectively.
  • The Act limits the deductibility of executive and employee compensation to $500,000 per applicable individual for health insurance providers.

Tax Advantaged Savings Accounts (HRA, FSA, HSA, MSA)

The Affordable Care Act excludes the costs for over-the-counter drugs not prescribed by a doctor from being reimbursed through an HRA or health FSA and from being reimbursed on a tax-free basis through a Health Savings Account (HSA) or Archer Medical Savings Account.

The tax on distributions from a Health Savings Account or an Archer MSA that are not used for qualified medical expenses is increased to 20% of the disbursed amount (from 10% for HSAs and from 15% for Archer Medical Savings Accounts.)

Medicaid

New Medicaid Eligibility:

  • Health Reform 2010 expands Medicaid to all individuals under age 65 with incomes up to 133% of the federal poverty level (FPL) Income for these purposes is based on modified adjusted gross income. At the latest, newly eligible Medicaid beneficiaries must be enrolled into the Medicaid program no later than January 2014.
  • All newly eligible adults will be guaranteed a benefit package that at least provides the essential health benefits available through the Exchanges.
  • States have the option to expand enrollment to childless adults beginning in 2011.
  • The Act encourages Medicaid programs to include preventive services.

NOTE: A state will be exempt from the requirement for non-disabled adults with incomes above 133% FPL for any year from January 2011 through December 31, 2013 if the state certifies that it is experiencing a budget deficit or will experience a deficit in the following year.

Tobacco Cessation: Effective October 1, 2010, Medicaid is required to offer coverage for tobacco cessation services for pregnant women. Also, the Act encourages Medicaid programs to include preventive services.

Minimum Medicaid Benefits: States must maintain current Medicaid eligibility levels for children until 2019 and maintain current Medicaid eligibility levels for adults until the Exchanges are fully operational.

Payments to doctors:

  • Medicaid payments in fee-for service and managed care for primary care services provided by primary care doctors (family medicine, general internal medicine or pediatric medicine) are required to be 100% of the Medicare payment rates for 2013 and 2014. Some analysts believe that this will encourage more doctors to accept Medicaid.
  • The Act also provides a 10% bonus payment to primary care physicians in Medicare from 2011 through 2015.

States are permitted to obtain a five year waiver of certain new health insurance requirements if the state can demonstrate that it provides health coverage to all residents that is at least as comprehensive as the coverage required under an Exchange plan and that the state plan does not increase the federal budget deficit. (Effective January 1, 2017).

Nursing Homes: The Act requires skilled nursing facilities under Medicare and Nursing facilities under Medicaid to disclose information regarding ownership, accountability requirements and expenditures. (Standardized information about nursing homes will be available on a Medicare website so Medicare enrollees can compare facilities.)

Children's Health Insurance Program (CHIP)

States are required to maintain current income eligibility levels for children in Medicaid and the Children's Health Insurance Program (CHIP) until 2019 and extend funding for CHIP through 2015.

CHIP-eligible children who are unable to enroll in the program due to enrollment caps will be eligible for tax credits in the Exchanges.

States must maintain current CHIP eligibility levels for children until 2019.

Small Businesses Are Encouraged To Offer Employees Health Plans

Tax Credit: 2010 - 2014: The Act provides a tax credit to small employers with no more than 25 employees and average annual wages of less than $50,000 that purchase health insurance for employees.

  • Phase 1: For tax years 2010 through 2013:
    • A tax credit of up to 35% of the employer's contribution toward an employee's health insurance premium if the employer contributes at least 50% of the total premium cost or 50% of a benchmark premium.
    • The full credit will be available to employers with 10 or fewer employees and average annual wages of less than $25,000.
    • The credit phases-out as firm size and average wage increases.
    • Tax-exempt small businesses meeting these requirements are eligible for tax credits of up to 25% of the employer's contribution toward the employee's health insurance premium.
    • For a complete understanding of the law, click here.
  • Phase II: For tax years 2014 and later:
    • For eligible small businesses that purchase coverage through an Exchange, a tax credit of up to 50% of the employer's contribution toward an employee's health insurance premium if the employer contributes at least 50% of the total premium cost.
    • The credit will be available for two years.
    • The full credit will be available to employers with 10 or fewer employees and average annual wages of less than $25,000.
    • The credit phases-out as firm size and average wage increases.
    • Tax-exempt small businesses meeting these requirements are eligible for tax credits of up to 35% of the employer's contribution toward the employee's health insurance premium.

Wellness: The Act provides grants for up to 5 years to small employers that establish wellness programs. (Funds have been appropriated beginning in fiscal year 2011.)

Sale of Health Insurance Across State Lines

Health Reform 2010 permits states to form health care choice compacts and allows insurers to sell policies in any state participating in the compact. Compacts may not take effect before January 1, 2016.

Compacts will only be approved if they provide coverage that is at least as comprehensive and affordable as coverage provided through the Exchanges.

Home Care Insurance (CLASS)

The Act establishes a national, voluntary insurance program for purchasing coverage for home care. The act refers to this as "community living assistance services and supports" to be referred to as the CLASS program. CLASS is effective January 1, 2011. The Act is intended to eliminate the situation where people may be required to spend down all their assets in order to obtain this care through Medicaid.

The Act includes a five-year vesting period. Then the CLASS program will provide individuals with functional limitations a cash benefit. The cash benefit will be not less than an average of $50 per day to purchase non-medical services and supports necessary to stay at home.

Any individual who is at least 18 years old  and actively working will be automatically enrolled (unless they op out), and pay their premiums through payroll deduction or another alternative method. Any non-working spouse may enroll in the program and pay their premiums through an alternative payment procedure. 

The Act does not affect Long Term Care Insurance.

To Qualify For Benefits

To qualify for benefits, individuals must:

  • Be at least 18 years old AND
  • Have voluntarily contributed to the program on a monthly basis for at least five years.

Benefits are limited to people who:

  • Are unable to perform two or more activities of daily living (ADL) (such as eating, dressing, transferring) OR
  • Have an equivalent cognitive disability that requires supervision or hands on assistance to perform activities of daily living. For example, people with traumatic brain injury, Alzheimer's disease, multiple sclerosis or mental retardation AND
  • The physical or mental limitation is expected to last for a continuous period of 90 days or more. 

Eligibility for benefits will be determined by state disability determination centers.

Benefits

There will be two cash benefit tiers:

  • Tier 1 benefits will be payable to eligible individuals who are unable to perform 2 or more ADLS or have the equivalent cognitive impairment. Initially, the benefit will be $50 per day
  • Tier 2 benefits  will be payable to individuals who are unable to perform 4 or more ADL's or have the equivalent cognitive impairment. Initial benefit wilbe $100 per day.   
The monthly case benefit will be posted monthly to a debit account or a "Choice Account."  Individuals who do not use the full monthly amount may roll it over from month to month, but not roll it over from year to year.

If an individual becomes ineligible for CLASS benefits (by improvement in functional status or death), CLASS Act benefits will stop. Any left-over balance of available money remaining in the individual’s account will not be payable. If an eligible individual does choose to move into an institutional facility, CLASS Act benefits will be used to pay those associated expenses.  

Relationship of CLASS Act Insurance Program to Social Security Disability Insurance 

Eligibility for CLASS Act benefits will be independent of whether or not an individual is eligible for Social Security Disability Insurance (SSDI), so participation in the CLASS Act insurance program will not impair an individual’s ability to remain qualified for SSDI.

Relationship of CLASS Act Insurance Program to Social Security Retirement Benefits

Similarly, eligibility for CLASS Act benefits will be independent of retirement benefits eligibility. 

Relationship to Medicaid

An individual who is eligible for CLASS Act benefits is also eligible for the long term care benefit under Medicaid, CLASS Act benefits can be used to offset the costs to Medicaid.

Relationship to Health Insurance 

The “Class” program benefit does not replace the need for basic health insurance --- it provides a mechanism to pay for those non-medical expenses that allow a disabled person to remain independent.

Relationship to Private Long Term Care Insurance

The “Class” program benefit can be an addition to long term care insurance.  It provides a consistent, basic cash benefit to glove with the insurance products that provide more intense medical services over a shorter period of time.

Skilled Nursing Facilities: Disclosure

The Act requires skilled nursing facilities to disclose information regarding ownership, accountability requirements, and expenditures. It also requires posting on a website standardized information on nursing facilities.

Wellness Programs At Work

The Act encourages the adoption of wellness programs by employers. Small employers are given grants. Small employers that establish wellness programs may be given grants for up to five years.

Employers are permitted to offer employees rewards for participating in wellness programs. For example, employers can offer premium discounts, waivers of cost-sharing requirements or benefits that would otherwise not be provided. (Effective January 1, 2014).

Nutritional Information: Chain Restaurants, Vending Machines

The Act requires chain restaurants and food sold from vending machines to disclose the nutritional content of each item. Regulations are to be issued within one year of enactment of the Act.

Medical Professionals Training And Recruitment

The Act encourages the training of medical professionals, particularly in primary care and programs that focus on integrating physical and mental health services and the training and recruitment of doctors and nurses to serve in rural and underserved areas.

Clinical Trials

Summary

Basically, the Act provides that effective 2014:

  • Insureds with a life-threatening condition can not be discriminated against for participating in a clinical trial.
  • The costs and services that would be covered by the plan if there were no clinical trial have to be covered.

If the law of the state in which you reside provides more protections about clinical trials, the state law prevails.

Coverage

Both group and individual health insurance plans:

  • May not drop coverage just because an insured chooses to take part in a clinical trial.
  • May not prevent an insured from participating in a clinical trial.
  • Must cover routine patient costs for items and services furnished in connection with participation in a clinical trial. The costs to be covered are the type otherwise covered by the plan for a person who is not enrolled in a clinical trial. 
  • If the Plan has in network providers:
    • If  there is at least one provider who participates in a clinical trial, the plan may require that you enter the clinical trial through the in network provider if the provider will accept you as a participant in the clinical trial. 
    • The plan does not have to cover benefits outside of the network unless out-of-network benefits are otherwise provided under the plan.
  • Plans do not have  to cover:
    • The item, device or service being studied in the trial (for example, a drug being tested).
    • Services that are clearly inconsistent with widely accepted and established standards of care for a particular diagnosis.

Who is covered

The Act only relates to "covered individuals" who are defined as:

  • People who are eligible to participate in a clinical trial according to the trial protocol with respect to treatment of cancer or other life-threatening disease or condition AND
  • The referring health care professional has concluded that your participation in the trial would be appropriate OR
  • You provide medical and scientific information establishing that your participation in the trial would be appropriate.

What trials are covered

phase I, II, III or IV clinical trial that is conducted in relation to the prevention, detection or treatment of cancer or other life-threatening disease or condition.

The trial must be funded or approved by a specified entities including:

  • The National Institutes of Health 
  • The Centers For Disease Control And Prevention 
  • The Agency for Health Care Research and Quality 
  • The Centers for Medicare & Medicaid Services 
  • A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants.

Life-threatening defined

The Act defines "life-threatening" for purposes of the clinical trial provisions as "any disease or condition from which the likelihood of death is probable unless the course of the disease or condition is interrupted."