An Abbreviated New Drug Submission (ANDS) is a written request to obtain marketing approval for a generic drug in Canada.

Sponsor Attestation Checklist for Abbreviated New Drug Submissions (ANDSs)

Guidance Document: Use of a Foreign-sourced Reference Product as a Canadian Reference Product

An Abbreviated New Drug Submission (ANDS) is a written request to Health Canada to obtain marketing approval for a generic drug. An ANDS supplies information regarding data on studies comparing the proposed drug to the approved brand name drug, called the “reference drug,” and asks for data from studies conducted on the generic drug.﻿﻿ The ANDS also supplies information about studies comparing the bioavailability of the brand name drug with that of the proposed generic drug, and about the results of bacterial endotoxin tests for sterile drugs. The submission provides critical information, such as data on studies comparing the generic drug to the approved brand name drug and their respective bioavailabilities. An Abbreviated New Drug Submission must be approved by Health Canada, the country’s federal department in charge of national health care, under Canada’s Food and Drug Regulations, before the generic drug can be marketed in the country.

Abbreviated New Drug Submission (ANDS)

Accountable care organizations (ACOs) are provider networks designed under the Affordable Care Act to improve cost efficiency and quality of medical treatment.

Accountable Care Organizations, Explained

The ACO system has grown beyond the Medicare environment to include private payer networks and has retained the fee-for-service payment model of Medicare. Accountable care organizations were designed to share information, provide more cost-effective treatment services, and eliminate redundancies for patients in the Medicare system. Accountable Care Organizations (ACOs) are collaboratives that provide Medicare patients comprehensive healthcare coverage, formed as part of the Affordable Care Act (Obamacare). ACOs were created to cut out redundancies for Medicare patients by incentivizing providers to share information and provide cost-effective treatment services.

Accountable Care Organizations (ACOs)

Actuarial value is the percentage of total average costs for covered benefits that will be paid by a health insurance plan. 

The 'Metal' Categories: Bronze, Silver, Gold & Platinum

Actuarial value is the percentage of total average costs for covered benefits that will be paid by a health insurance plan under the Patient Protection and Affordable Care Act (ACA).
Also known as "Obamacare," the U.S. health reform enacted March 23, 2010, established health insurance plans available on the Health Insurance Marketplace that are divided into four “metallic” tier levels—Bronze, Silver, Gold, and Platinum—based on the actuarial values. Silver plans pay 70 percent, Gold plans pay 80 percent and Platinum plans pay 90 percent. For example, if a Bronze plan pays (on average) 60 percent of covered medical expenses, Bronze policyholders would be responsible for (on average) the remaining 40 percent of the expenses excluding premiums, which are not included as part of the calculation. For example, Bronze Plan A might offer a $5,500 deductible and 0 percent coinsurance for a monthly premium of $250, while Bronze Plan B offers a $2,700 deductible with 50 percent coinsurance for a monthly premium of $300. Health insurance plans, regardless of their actuarial value, have various deductible, copayment, and coinsurance levels that affect the monthly premium and how (and even when) the individual will pay for medical care.

Actuarial Value

Allied healthcare professional liability insurance provides coverage for nurses and other healthcare professionals who are not physicians.

Health Insurance Portability and Accountability Act of 1996 (HIPAA)

Allied healthcare professional liability insurance provides coverage for medical professionals who are not physicians, such as nurses, physical therapists and dentists. Allied healthcare professional liability insurance provides coverage for non-physician healthcare professionals such as nurses, physician' assistants, midwives, dentists, physical therapists, occupational therapists, medical technicians and others. Allied healthcare professional liability insurance provides coverage for medical professionals who are not physicians, such as nurses, physical therapists and dentists. Allied healthcare professional liability insurance is often marketed through industry associations, which offer advantageous premium pricing and coverage by creating a larger pool of insured. In addition to professional liability exposure, a comprehensive policy will cover healthcare data protection risks and the risks associated with non-compliance with the Health Insurance Portability and Accountability Act (HIPPA).

Allied Healthcare Professional Liability Insurance

Ancillary benefits are a secondary type of health insurance that covers miscellaneous medical expenses that are incurred during a stay at the hospital.

Ancillary benefits are a secondary type of health insurance coverage that covers miscellaneous medical expenses that are incurred during a stay at the hospital. Lower employer FICA contributions if the business takes advantage of Section 125, which allows employees to pre-tax dollars for these benefits
Ancillary benefits enhance the employer’s reputation among employees
Offering ancillary benefits makes a business more competitive in the employment marketplace Ancillary products respond to workers’ needs to access services that are important to have a good quality of life
With ancillary dental and vision benefits, workers get preventative care, not just care when a problem develops Ancillary benefits are a secondary type of health insurance coverage that covers miscellaneous medical expenses that are incurred during a stay at the hospital. There are many positive aspects to ancillary benefits, including, but not limited to, the use of pre-tax dollars to pay for them, and they pay for preventative care as well.

Ancillary Benefits

An Archer MSA is a medical savings account established in the 1990s and named after Texas Congressman Bill Archer.

DRAFT Publication 969, Health Savings Accounts and Other Tax-Favored Health Plans, Pages 12-16, as of Oct. 30, 2020

DRAFT Publication 969, Health Savings Accounts and Other Tax-Favored Health Plans, Page 12, as of Oct. 30, 2020

DRAFT Publication 969, Health Savings Accounts and Other Tax-Favored Health Plans, Page 13, as of Oct. 30, 2020

An Archer MSA is a medical savings account (MSA) enacted in 1996 and named for former Texas Congressman Bill Archer, who sponsored the amendment that led to its establishment. However, in considering such a switch, the differences between the terms of the insured’s Archer MSA and the proposed HSA, in particular the ceiling on Archer MSA deductibles and the absence of any limit on HSA deductibles, should be evaluated. An Archer MSA is a medical savings account (MSA) enacted in 1996 and named for former Texas Congressman Bill Archer, who sponsored the amendment that led to its establishment. The maximum annual contribution to an Archer MSA is 75% of the HDHP’s deductible
amount for a family plan and 65% of that amount for an individual plan.﻿﻿ The HSA contribution limits are more generous and are set as specific amounts adjusted regularly for inflation. As with the more recent health savings account (HAS), an Archer MSA offered the account holder a tax-advantaged way to save for medical expenses.

Archer MSA

In place of group health insurance, employers might offer a benefit allowance to employees to pay for plans.

Individual Coverage Health Reimbursement Arrangements (HRAs)

A benefit allowance is money that a company or government agency provides to an employee for a specific purpose, such as transportation, healthcare costs, or a flexible spending account. Small businesses that may not have the resources to offer health insurance and other benefit plans to their employees might use a benefit allowance as an option to create access to coverage to their workers. Employers could also allow their employees to put a benefit allowance toward life insurance, disability insurance, vision care, or any number of other benefits. Along with the benefit allowance, an employer might designate a party to serve as a health insurance broker to help employees pick a plan. An employer may provide a benefit allowance to its workers for a specific use, like for childcare, transportation, life insurance, or health benefits.

Benefit Allowance

Biotechnology is the scientific study using living organisms to develop healthcare products and processes. Learn how to invest in biotech companies.

10 Breakthrough Treatments That Will Change Medicine in 2021.

Biotech Valuation Idiosyncrasies and Best Practices

Biotechnology is a science-driven industry sector that uses living organisms and molecular biology to produce healthcare-related products. Massive strides in DNA research in the 1970s
The development of the first biotech-derived drugs and vaccines to treat diseases such as cancer and hepatitis B in the 1980s
The identification of numerous genes and the introduction of new treatments in decades for managing multiple sclerosis and cystic fibrosis in the 1990s
The completion of the human genome sequence in the 1990s, which made it possible for scientists worldwide to research new treatments for diseases with genetic origins like cancer, heart disease, and Alzheimer’s Some of the most frequently used biotechnology medical products recently introduced include the following:
AbbVie's Humira, which is used to treat arthritis, psoriasis, and Crohn's disease.
Roche's Rituxan, which is used to slow the growth of tumors in several types of cancer.
Amgen/Pfizer's Enbrel, which is used to treat several autoimmune diseases.
The top U.S.-based biotechnology firms in terms of market capitalization as of April 2021 were Johnson & Johnson ($437.19 billion), Roche ($304.60 billion), Pfizer ($218.11), and Novartis ($201.21). It's not uncommon, therefore, for biotech companies to work together with larger, more established firms to achieve their research and development goals.
Biotechnology and pharmaceutical companies both produce medicines. At the other extreme are thousands of small, dynamic biotech companies, many of which are engaged in various areas of the medical industry, such as drug development, genomics, or proteomics while others are involved in areas like bioremediation, biofuels, and food products.

Biotechnology

A capitated contract is a healthcare plan that provides payment of a flat fee for each patient it covers. The healthcare provider is paid a set dollar amount per month to see patients regardless of how many treatments or visits are made.

A capitated contract is a healthcare plan that allows payment of a flat fee for each patient it covers. Also, because the physician, hospital, or health system are responsible for the enrolled member's health regardless of cost, in theory, capitation motivates the healthcare provider to focus on health screenings (mammograms, pap smears, PSA tests), immunizations, prenatal care, and other preventative care that can help keep plan members healthy, with less reliance on costly specialists. Given that most individuals enrolled in a health plan will never use the services in any given month, capitation arrangements should naturally balance out high-frequency users with plan members who use little or no healthcare every month. Within a capitated contract, the healthcare provider is paid a set dollar amount per month to see patients regardless of how many treatments or the number of times the physician or clinic sees the patient. However, new types of healthcare plans are moving from paying for volume to paying for value – incorporating cost, consumer health outcomes, and consumer experience – with capitation rates based on performance at the “most advanced” end of the scale.

Capitated Contract

Capitation payments are monthly payments received by a physician, clinic, or hospital per patient enrolled in a health plan with a capitated contract. 

Medicaid Managed Care Cost Savings – A Synthesis of 24 Studies

The Payment Reform Landscape: Capitation With Quality

Effects of Compensation Methods and Physician Group Structure on Physicians' Perceived Incentives to Alter Services to Patients

Table of Contents
What Are Capitation Payments? Pros
*   Dissuades providers from unnecessary services
Promotes efficiency and cost-control
Reduces bookkeeping overhead
Allows providers to focus on face-to-face services, preventative care
*   May cause providers to use cheaper drugs/services
Encourages providing fewer services
High population areas means low capitation rates
Can lead to long wait times and short visits Rates for capitation payments are developed using local costs and average utilization of services
HMOs and IPAs tend to benefit from operating in a healthcare capitation payment system.
Capitation payments are designed to lower the high costs of healthcare. Most capitation payment plans for primary care services include basic areas of healthcare:
Preventive, diagnostic, and treatment services
Injections, immunizations, and medications administered in the office
Outpatient laboratory tests that are done in the office or at a designated laboratory
Health education and counseling services performed in the office
Routine vision and hearing screening What Is a Capitation Agreement?
What Are Capitation Fees?
What Is the Difference Between Capitation and Fee-For-Service?
Bottom Line
Capitation payments are payments agreed upon in a capitated contract by a health insurance company and a medical provider.

Capitation Payments

A carryover provision—also known as a fourth-quarter deductible carryover—is a clause commonly found in health insurance contracts.

ADDITIONAL RELIEF FOR CORONAVIRUS DISEASE (COVID-19) UNDER § 125 CAFETERIA PLANS

A carryover provision—also known as a fourth-quarter deductible carryover—is a clause commonly found in health insurance contracts. The purpose of carryover provisions is to enable policyholders to reduce their out-of-pocket expenses in the following year by applying a portion of the current year's claims against the next year's deductible. Under the terms of the carryover provision, a portion of the excess medical expenses can be applied toward the policyholder’s deductible in the following year, thereby limiting the amount of money they must pay toward that deductible themselves. It entitles the policyholder to have a portion of their current year’s claims applied toward the next year’s deductible, thereby reducing their out-of-pocket expenditures. When purchasing a health insurance policy, the policyholder is responsible for covering the cost of any expenses up to a predetermined annual amount, which is known as the policy’s “deductible”.

Carryover Provision

Case Management is the planning, processing, and monitoring of the healthcare services given to a patient by a coordinated group of healthcare providers.

The definition of case management is the planning, processing, and monitoring of the healthcare services given to a patient by a coordinated group of healthcare providers. Case management in a rehabilitation center, for example, would use mental health service providers to follow up with patients.
The case management process begins when a new case is “opened.” A case manager evaluates what services are considered medically necessary when a new case is started and works with different service providers to ensure that the required services are being given in the appropriate setting. Case management, sometimes known as dynamic case management, work is usually done by professionals in the healthcare field with experience in working in a medical setting such as a hospital. Case management is designed to provide for a patient’s needs while controlling costs, with a case manager maintaining information on a patient’s outcomes.

Case Management

Catastrophic health insurance is medical coverage open to people under 30 and adults of any age who have a government-approved general hardship exemption. 

Catastrophic health insurance is a type of medical coverage open to people under 30 years of age and adults of any age who have a government-approved general hardship exemption. Catastrophic health insurance is a type of low-cost, high-deductible health insurance that mainly protects against severe or critical medical emergencies. Catastrophic health insurance was first introduced by Senator Abraham Ribicoff in October 1973 when he proposed a bipartisan bill for catastrophic health insurance coverage. Catastrophic health insurance is a type of medical coverage open to people under 30 years of age and adults of any age who have a government-approved general hardship exemption. If you buy this type of plan, you won’t be able to take advantage of any health insurance premium tax credits you might be eligible for based on your income, which means that some consumers can get better coverage at a lower cost by choosing a bronze plan and using the subsidies.

Catastrophic Health Insurance

Catastrophic illness insurance covers expenses for major health conditions such as heart attack, stroke or cancer, but does not cover routine care.

Tracing the History of CMS Programs: From President Theodore Roosevelt to President George W. Bush

Health Insurance Coverage and the Affordable Care Act, 2010–2016

Catastrophic illness insurance is a type of coverage that protects the insured for a specific and severe health problem over the defined period. The costs associated with critical diseases can be substantial, cause financial distress, and even bankruptcy, thus necessitating catastrophic illness insurance.
The need for catastrophic illness insurance depends in no small extent on a country’s healthcare system. Some life insurance policies offer additional benefits for critical illness known as dread disease riders.
Catastrophic coverage may not include pre-existing conditions and usually includes an elimination period. Catastrophic illness insurance is a type of coverage that protects the insured for a specific and severe health problem over the defined period. Catastrophic illness insurance is a type of coverage that protects the insured for a specific and severe health problem over the defined period.

Catastrophic Illness Insurance

A certificate of need (CON) is a legal document that is required in many states in order to construct a new healthcare facility.

A certificate of need (CON) is a legal document that is required in order to construct a new healthcare facility. In the case of Illinois, the specific CON law in question has been in place since 1974 and regulates the construction of a wide range of health care facilities, including long-term care facilities, hospitals, birthing centers, and dialysis centers. In order to obtain a CON, developers of healthcare facilities must apply to the local governmental authorities by making the case for why the community in question would benefit from that new development. Critics of the CON program contend that the system poses an unnecessary barrier to entry in the healthcare market, effectively protecting established health facilities from competition. Traditionally, advocates for the CON framework have contended that the systems help prevent unnecessary spending on healthcare infrastructure and services, and that they can help states to direct such infrastructure toward underserved regions.

Certificate of Need (CON)

 The Children’s Health Insurance Program (CHIP) is a government program that provides health insurance to children age 18 or younger. 

H.R.2 - Children's Health Insurance Program Reauthorization Act of 2009

We’re a family of four with an income of $47,000 a year. What kinds of subsidies are available to help us purchase insurance through the exchanges?

Patient Protection and Affordable Care Act

The Children’s Health Insurance Program (CHIP) provides medical coverage for individuals age 18 and younger whose parents earn too much income to qualify for Medicaid, but not enough to pay for private coverage. In addition, the following criteria for CHIP eligibility are from the Centers for Medicare and Medicaid Services website:
Uninsured (determined ineligible for Medicaid and not covered through a group health plan or creditable health insurance)
A citizen or meet immigration requirements
A resident of the state
Eligible within the state’s CHIP income range, based on family income, and any other state specified rules in the CHIP state plan
Typically, a family of four earning up to $106,000 before taxes (as of 2021) a year will qualify for CHIP, but the limits vary on a state-by-state basis. CHIP covers basic healthcare, including vision and dental care, prescriptions, emergency services, x-rays, sick visits, immunizations, annual checkups, and mental health services for eligible children age 18 and under. U.S. citizens or those who meet immigration requirements up to age 18 are eligible for CHIP benefits if their family meets the CHIP income requirements. The Children’s Health Insurance Program (CHIP) provides medical coverage for individuals age 18 and younger whose parents earn too much income to qualify for Medicaid, but not enough to pay for private coverage.

Children’s Health Insurance Program (CHIP)

The Consolidated Omnibus Budget Reconciliation Act (COBRA) provides for continuing health insurance coverage for employees who lose their jobs.

An Employer's Guide to Group Health Continuation Coverage Under COBRA

FAQs on COBRA Continuation Health Coverage for Workers

Federal Small Employer Exemption Often Eliminated by State COBRA Law

The Consolidated Omnibus Budget Reconciliation Act (COBRA) is a landmark federal law, passed in 1985, that provides for continuing group health insurance coverage for some employees and their families after a job loss or other qualifying event. The Consolidated Omnibus Budget Reconciliation Act (COBRA) is a landmark federal law, passed in 1985, that provides for continuing group health insurance coverage for some employees and their families after a job loss or other qualifying event. The Consolidated Omnibus Budget Act (COBRA for short, or the COBRA Act as it is sometimes called, despite the redundancy) offers the continuation of medical coverage for workers who would otherwise lose their health insurance when they lose their employment. Though COBRA participants will generally pay more for their insurance than active employees will, COBRA may still be less expensive than buying an individual (non-group) health plan with comparable benefits, especially if the participant doesn't qualify for an Affordable Care Act subsidy. Because employers typically pay 72% to 83% of insurance premiums, according to the Kaiser Family Foundation's 2020 Employer Health Benefits Survey, opting for COBRA coverage often means an individual's out-of-pocket costs for coverage will rise substantially.

Consolidated Omnibus Budget Reconciliation Act (COBRA)

Coinsurance is the claim amount an insured must pay after meeting deductibles and is also the level at which an owner must protect property. 

Coinsurance is the amount, generally expressed as a fixed percentage, an insured must pay against a claim after the deductible is satisfied. With coinsurance, the insured must pay the deductible before the company covers its 80% of the bill.
Assume you take out a health insurance policy with an 80/20 coinsurance provision, a $1,000 out-of-pocket deductible, and a $5,000 out-of-pocket maximum. In health insurance, a coinsurance provision is similar to a copayment provision, except copays require the insured to pay a set dollar amount at the time of the service. On the other side, it is also more likely that the out-of-pocket maximum will be reached earlier in the year, resulting in the insurance company incurring all costs for the remainder of the policy term.
Copay plans spread the cost of care over a full year and make predicting your medical expenses easier. For example, if a property has a value of $200,000 and the insurance provider requires an 80% coinsurance, the owner must have $160,000 of property insurance coverage.

Coinsurance

Commercial health insurance is health insurance provided and administered by public and private companies rather than by the government.

U.S. Health Insurance Industry Analysis Report

Health insurance plan & network types: HMPs. PPOs. and more

HMO vs. PPO plans – what are the differences?

Understanding Commercial Health Insurance

Definition of Commercial Health Insurance

Commercial health insurance is health insurance provided and administered by nongovernmental entities. Two of the most popular types of commercial health insurance plans are the preferred provider organization (PPO) and health maintenance organization (HMO).
Most commercial insurance is provided as group-sponsored insurance, offered by an employer.
Although not administered by the government, plan offerings, to a large degree, are regulated and overseen by each state.
Commercial health insurance policies are primarily sold by for-profit public and private carriers. Technically, there is no difference: Commercial health insurance is provided by private issuers—as opposed to government-sponsored health insurance, which is provided by federal agencies. Common types of commercial health insurance include HMOs, PPOs, POS (point-of-service) plans, HRAs (health reimbursement accounts), and LTC (long-term care) plans. In broad terms, any type of health insurance coverage that isn’t provided or maintained by a government-run program can be considered a type of commercial insurance.

Commercial Health Insurance

Cost-sharing reductions are a type of federal subsidy distributed as discounts that help reduce out-of-pocket costs for health care expenses.

Health Insurance Premium Tax Credit and Cost-Sharing Reductions

Explaining Health Care Reform: Questions About Health Insurance Subsidies

Table of Contents
What Are Cost-Sharing Reductions?
How They Work
Types of Cost-Sharing Reductions
Criticism of CSRs This subsidy applies to anyone with a household income up to and including 250% FPL as follows:
Direct Cost-Sharing Reductions
Household Income Level
Insured Pays
100% to 150% FPL
151% to 200% FPL
201% to 250% FPL
Direct cost-sharing reductions help those with both minimal health care needs and those who spend a big part of their income on medical care. The term cost-sharing reductions (CSRs) refers to federal subsidies provided to individuals to help reduce their out-of-pocket costs for health care expenses. In order to qualify for CSRs, individuals must:
not be eligible for public coverage, such as Medicaid
be ineligible for coverage through an employer
apply for coverage through an exchange
enroll in a Silver plan
have a household income at or above 100% of the federal poverty line (FPL)
file annual tax return In order to mitigate the cost of coverage—which can also be very expensive—the law also introduced premium tax credits and cost-sharing reductions (or extra savings) designed to help individuals and families who fall below a certain income threshold.

Cost-Sharing Reductions (CSRs)

Creditable coverage is a health insurance, prescription drug, or another health benefit plan that meets a minimum set of qualifications.

Creditable Coverage and Late Enrollment Penalty

H.R.3590 - Patient Protection and Affordable Care Act

Creditable coverage is a health insurance, prescription drug, or other health benefit plan that meets a minimum set of qualifications. In order to be considered creditable, a prescription drug plan must meet these four requirements:
Provide coverage for both brand and generic prescription medication
Provide the policyholder with a reasonably broad option of medication providers, or a mail-order option
Pay at least 60% of the cost of prescription expenses
Either not have an annual benefit maximum, or have a low deductible
You may have creditable coverage through a current or former employer, trade union, or one of the following:
Federal Employee Health Benefits (FEHB) Program
Veterans' Benefits
TRICARE (military health benefits)
Civilian Health and Medical Program of the Department of Veterans Affairs (CHAMPVA)
Indian Health Services
You also might have creditable coverage if you get health insurance coverage through your spouse's employer or if you’re on a COBRA plan. Most companies offering prescription drug coverage to Medicare-eligible beneficiaries have to disclose their status as creditable or non-creditable coverage programs. Most companies that provide prescription drug coverage to Medicare-eligible beneficiaries must disclose their status as creditable or non-creditable coverage. Creditable coverage is a health benefit, prescription drug, or health insurance plan—including individual and group health plans—that meet a minimum set of qualifications.

Creditable Coverage

Dependent care flexible spending accounts (FSAs) let employees use tax-exempt funds to pay for childcare expenses they incur while at work.

Publication 503: Child and Dependent Care Expenses

Looking ahead: How the American Rescue Plan affects 2021 taxes, part 1

Publication 969: Balance in FSA," Pages 16-17.

Dependent care flexible spending accounts (FSAs) The 2021 dependent care FSA contribution limit was increased by the American Rescue Plan Act to $10,500 for single filers and couples filing jointly (up from the previous limit of $5,000) and $5,250 for married couples filing separately (up from the previous limit of $2,500).
You can use a dependent care FSA to cover daycare expenses for a child who’s age 12 or younger. Employees can also use FSAs to cover care expenses for qualifying dependent adults who live in their homes, including spouses and parents.﻿﻿ Parents and guardians can save a significant amount of money when they use an FSA, rather than after-tax dollars, to pay for dependent-care expenses. A dependent care FSA is designed to cover daycare expenses that employees incur because they are working, so a taxpayer must have earned income in order to have a dependent care FSA. Employees can also use dependent care FSAs to cover care expenses for qualifying dependent adults who live in their homes, including spouses and parents.

Dependent Care Flexible Spending Account (FSA)

European Medicines Agency (EMA) is a government entity that promotes access to and approval of medications in European countries.

Table of Contents
Expand The EMA also monitors the safety of medicines after they have been approved, through a process called pharmacovigilance.
The EMA has established joint task forces with the heads of other medicine agencies to explore the costs and benefits and how to probably utilize big data.
The EMA defines pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.” While the EMA and FDA are similar, they do not always approve the same drugs, and the EMA is perceived as being less strict than the FDA in its approval process, meaning that some drugs are approved in Europe that are not approved in the United States. Also, the EMA does not approve all drugs that are used in EU countries; individual countries may choose to approve drugs that the EMA has not approved. The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU) whose goal is to promote and protect human and animal health.

European Medicines Agency (EMA)

A flexible spending account (FSA) is a type of savings account, usually for healthcare expenses, that sets aside funds for later use.

DRAFT Publication 969, Health Savings Accounts and Other Tax-Favored Health Plans, Pages 16-18

e-Alert – COVID-19 – Considerations for Tax-Advantaged Accounts in Response to COVID-19

IRS: Cost of Home Testing for COVID-19 Is Eligible Medical Expense; Reimbursable Under FSAs, HSAs

COVID-19 GUIDANCE UNDER §125 CAFETERIA PLANS AND RELATED TO HIGH DEDUCTIBLE HEALTH PLANS, IRS Notice 2020-29

A flexible spending account (FSA) is a type of savings account that provides the account holder with specific tax advantages. The IRS issued a statement notifying taxpayers that at-home COVID-19 tests and personal protective equipment such as face masks and hand-sanitizer are both considered eligible medical expenses that can be paid or reimbursed under health flexible spending arrangements (FSAs), health savings accounts (HSAs), and health reimbursement arrangements (HRAs).
All the money set aside in an FSA generally must be used by the end of the plan
year. In addition, employers can elect to allow employees to apply unused amounts remaining in a health FSA at the end of a grace period or plan year ending in 2020 to pay or reimburse medical care expenses incurred through December 31, 2020. Another type of FSA is a dependent-care flexible spending account, which is used to pay for childcare expenses for children age 12 and under and can also be used to pay for the care of qualifying adults,
including a spouse, who cannot care for themselves and meet specific Internal Revenue Service (IRS) guidelines. Also, the IRS will allow employers discretion to amend FSA plans for 2020 and 2021 either to allow employees to carry over more than the current $550 maximum, or to extend the grace period for using unspent FSA funds through December 31 of each year.

Flexible Spending Account (FSA)

A gatekeeper refers to requirements that must be met before qualifying for a long-term care plan or to an individual who oversees an HMO. 

A gatekeeper refers to requirements that must be met before an individual can qualify for a long-term care plan or to an individual who oversees a patient treatment through a health maintenance organization (HMO). A gatekeeper refers to requirements that must be met before an individual can qualify for a long-term care plan or to an individual who oversees a patient treatment through a health maintenance organization (HMO). In traditional HMO situations, the primary care physician is automatically the gatekeeper for a patient’s entire medical care, from approving tests and treatments to issuing referrals for specialty care within the plan’s network. Some of the cons of utilizing a medical gatekeeper, on the other hand, have been reported as doctors feeling like they are acting more as administrators than providers giving treatment, as well as concerns over primary care providers denying or limiting referrals in order to keep their patient load low, thus, patients feel like they are limited in their healthcare choices. The gatekeeper’s job, theoretically, might be thought of as a way to help the patient manage their care within the system, since a patient may not be aware of all the intricacies, rules and regulations in place, so using a gatekeeper can help streamline the process.

Gatekeeper

A grandfathered health plan is an insurance policy that is exempt from many consumer protections under the Affordable Care Act (ACA).

H.R. 3590 - Patient Protection and Affordable Care Act

The term "grandfathered health plan," or legacy health plan, refers to health insurance policies created or purchased prior to passage of the Affordable Care Act (ACA). Group and individual health insurance plans created or purchased before the passage of the ACA were allowed to continue, subject to certain restrictions. Therefore, sponsors are free to continue signing up new policyholders into a legacy plan, as long as the plan does not introduce changes that would substantially reduce benefits or increase coverage costs for policyholders. The ACA permitted legacy health plans to help consumers keep their coverage in place. If a company decides to discontinue a legacy health plan, it must notify policyholders in writing at least 90 days prior and offer other coverage options.

Grandfathered Health Plan

A group health insurance plan offers coverage at a lower premium than an individual plan and is available to employees of a company or organization.

Health Insurance Coverage for the Total Population

27+ Affordable Care Act Statistics and Facts (2021)

How much does group health insurance cost?

Table of Contents
 The most common type of group health plan is group health insurance, which is health insurance extended to members, such as employees of a company or members of an organization. A group health cooperative, also known as mutual insurance, is a health insurance plan owned by the insured members.﻿﻿ Insurance is offered at a reduced cost, and what they collect from members is based on claims paid. Group health insurance plans are one of the most affordable types of health insurance plans available. Government-sponsored health plans continue to provide care to those left out of employer-sponsored group health insurance plans.

Group Health Insurance

Learn more about the hardship exemption, which relieved individuals of having to pay a fee to the federal government for not having health insurance. 

Remarks on Signing the Patient Protection and Affordable Care Act

Individual Shared Responsibility Provision – Reporting and Calculating the Payment

Hardship exemptions , forms & how to apply

4 New Ways You Can Avoid Fines For Not Having Health Insurance

Meet the Press Blog: Latest news, analysis and data driving the political discussion

After you apply for a health coverage exemption

The term hardship exemption referred to an exemption granted to individuals who weren't able to afford health insurance due to personal and/or financial circumstances. Commonly referred to as Obamacare, it helped reduce the cost of health care for the American public by creating health care exchanges, expanding the eligibility for Medicaid, preventing insurance companies from denying coverage, and penalizing individuals who weren't covered. The term hardship exemption referred to an exemption granted to individuals who weren't able to afford health insurance due to personal and/or financial circumstances. Lived somewhere with just one company selling plans on the marketplace
Couldn’t find an affordable plan without abortion coverage.
Had personal circumstances preventing them from purchasing a marketplace plan, including not being able to find a plan with specialty care. Individuals granted exemptions didn't have to pay the individual mandate or Shared Responsibility Payment for not having health insurance during the hardship period.

Hardship Exemption

A high-deductible health plan is health insurance with a high minimum deductible for medical expenses that must be paid before insurance coverage kicks in.

Publication 969: Health Savings Accounts and Other Tax-Favored Health Plans

Table of Contents
What Is an HDHP?
Understanding HDHPs
Special Considerations
Advantages and Disadvantages
Example of an HDHP
The Bottom Line
What Qualifies an HDHP for an HSA? Pros
Lower monthly premiums
Works with a health-savings account, which is tax-free and covers qualified medical expenses
Higher out-of-pocket costs
Higher deductibles
As noted above, high-deductible health plans are suitable for people who are fairly healthy and don't need to pay for complicated medical procedures. The idea is to use them for qualified medical expenses that HDHPs don’t cover, including:
acupuncture
deductibles
dental services
vision care
prescription drugs
psychiatric treatments
other qualified expenses not covered by a health insurance plan
An HSA can cut costs if you face high deductibles. These plans fully cover routine preventive care without copays or coinsurance before the deductible kicks in for the following list (which is not exhaustive):
blood pressure screening
depression screening
diet and nutritional counseling
HIV screening
immunizations for diseases, such as chickenpox, the flu, and the measles
HDHP coverage comes with an annual catastrophic limit on out-of-pocket expenses for covered services from in-network providers. The term high-deductible health plan (HDHP) refers to a health insurance plan with a sizable deductible for medical expenses.

High-Deductible Health Plan (HDHP)

The Health Insurance Marketplace was established under Affordable Care Act and offers plans to individuals, families, and small businesses.

How to Save on Your Monthly Insurance Bill With a Premium Tax Credit

What Marketplace Health Insurance Plans Cover

"FACT SHEET: President Biden to Sign Executive Orders Strengthening Americans’ Access to Quality, Affordable Health Care."

The Health Insurance Marketplace is a platform that offers insurance plans to individuals, families, and small businesses. Many of the EHBs might seem like they would go without saying, but plans can skimp on basic coverage and some political opponents of the ACA have proposed eliminating EHBs since the passage of the ACA.
Required benefits include:
Ambulatory patient services
Emergency services
Hospitalization
Laboratory services
Mental health and substance use disorder services
Pregnancy, maternity, and newborn care
Prescription medications
Preventive and wellness services and chronic disease management
Pediatric services
Rehabilitative and habilitative services The Affordable Care Act (ACA) established the Marketplace as a means to extend health insurance coverage to millions of uninsured Americans. While the plans that insurers offer on the Marketplace can vary widely, the ACA requires that they must each satisfy 10 basic requirements or essential health benefits (EHBs). The Health Insurance Marketplace is a gateway for individuals, families, and small businesses to access health insurance.

ACA Health Insurance Marketplace

Health plan categories refers to the four types of health insurance plans that are differentiated based on the average expenses paid by the plan.

The 'metal' categories: Bronze, Silver, Gold & Platinum

Hardship exemptions, forms & how to apply

Health plan categories refer to the four types of health insurance plans that are differentiated based on the average percentage of healthcare expenses that will be paid by the plan. Your monthly premium will be low, but you’ll have to pay for most routine care yourself.
**Moderate** monthly premium
**Moderate** costs when you need care
Silver deductibles are usually lower than those of Bronze plans.
**Good choice Because each plan is different in terms of deductibles, copayments and coinsurance amounts, your share of the costs may come in the form of a large deductible with low coinsurance (for example, a $4,000 deductible with 10 percent coinsurance) or a small deductible with high coinsurance (such as a $1,500 deductible with 30 percent coinsurance). Gold and Platinum plans pay more on average toward healthcare expenses, while Silver and Bronze plans pay less. In addition to the four metallic coverage tiers, a catastrophic level is available to people under age 30 and to certain people over age 30 who are granted hardship exemptions based on income and other circumstances that would prevent them from getting a Bronze, Silver, Gold or Platinum plan.

Health Plan Categories

Health insurance is a type of insurance coverage that pays for medical and surgical expenses that are incurred by the insured. 

"Health insurance plan & network types: HMOs, PPOs and more."

"Your total costs for health care: Premium, deductible & out of pocket costs."

"Patient Protection and Affordable Care Act."

 "No health insurance? See if you'll pay a fee."

"New HHS Data Shows More Americans Than Ever Have Health Coverage Through the Affordable Care Act."

Table of Contents
What Is Health Insurance? Increasingly, health insurance plans also have copays, which are set fees that plan subscribers must pay for services such as doctor visits and prescription drugs; deductibles that must be met before health insurance will cover or pay for a claim; and coinsurance, a percentage of healthcare costs that the insured must pay even after they've met their deductible (and before they reach their out-of-pocket maximum for a given period).
Insurance plans with higher out-of-pocket costs generally have smaller monthly premiums than plans with low deductibles. Who needs health insurance?
How do you get health insurance?
How much does health insurance cost?
Health insurance is a contract that requires an insurer to pay some or all of a person's healthcare costs in exchange for a premium. As of 2021, an estimated 31 million people have health coverage through the Affordable Care Act.
Two public health insurance plans, Medicare and the Children's Health Insurance Program (CHIP), target older individuals and children (respectively) who need help with health insurance. Since 2010, the Affordable Care Act has prohibited insurance companies from denying coverage to patients with preexisting conditions and has allowed children to remain on their parents' insurance plan until they reach the age of 26.

Health Insurance

Health Insurance Portabiilty and Accountability ACT (HIPAA) is an act created by the U.S Congress in 1996 to ensure the privacy of personal medical data.

The Health Insurance Portability and Accountability Act (HIPAA) is an act created by the U.S. Congress in 1996 that amends both the Employee Retirement Income Security Act (ERISA) and the Public Health Service Act (PHSA). The Health Insurance Portability and Accountability Act (HIPAA) ensures that individual health-care plans are accessible, portable and renewable, and it sets the standards and the methods for how medical data is shared across the U.S. health system in order to prevent fraud. The Health Insurance Portability and Accountability Act (HIPAA) is an act created by the U.S. Congress in 1996 that amends both the Employee Retirement Income Security Act (ERISA) and the Public Health Service Act (PHSA). In an age of fitness-tracking apps and GPS-tracked, shareable data on everything from an individual’s daily step count to their average heart-rate, medications, allergies, and even menstrual cycles, there are new challenges for upholding standards in storing and protecting personal medical data. HIPAA was enacted in an effort to protect individuals covered by health insurance and to set standards for the storage and privacy of personal medical data.

Health Insurance Portability and Accountability Act (HIPAA)

A health maintenance organization (HMO) is a health insurance plan that provides health services through a network of doctors for a monthly or annual fee.

H.R.7974 - Health Maintenance Organization Act

Six Things You Need to Know About Getting a Medical Referral,

HMO s. PPO Plans - what are the differences?

The right HMO coverage, for the right care

Table of Contents
What Is an HMO?
How an HMO Works
PPO vs. HMO
HMO vs. POS
Advantages and Disadvantages HMO plans require that participants first receive medical care services from an assigned provider known as the primary care physician (PCP).
Preferred provider organizations (PPOs) and point-of-service plans (POS) are two types of healthcare plans that are alternatives to HMOs.
Health maintenance organizations (HMOs) provide health insurance coverage for a monthly or annual fee. HMO Questions and Answers
What is HMO Insurance?
What Are HMO Examples?
What Are the Benefits of an HMO?
What Is the Difference Between an HMO and Health Insurance?
Why Do HMOs Have a Bad Reputation? A point-of-service (POS) plan is like an HMO in that it requires a policyholder to choose an in-network primary care doctor and get referrals from that doctor if they want the plan to cover a specialist’s services. Table of Contents
What Is an HMO?
How an HMO Works
PPO vs. HMO
HMO vs. POS
Advantages and Disadvantages

Health Maintenance Organization (HMO)

The hospital insurance trust fund is Part A of Medicare, the United States' health insurance program for people age 65 and older.

The 2030 Problem: Caring for Aging Baby Boomers

Fact Sheet: 2019 Social Security and Medicare Trustees Reports

The Federal Hospital Insurance Trust Fund is also known as Part A of Medicare, the health insurance program for people aged 65 and older in the United States. The Federal Hospital Insurance Trust Fund is managed by the U.S. government and pays for specific healthcare services for Medicare recipients, including hospital stays, hospices, and skilled nursing facilities.﻿﻿﻿ It is not an actual fund, with money coming in or going out, but rather an accounting mechanism to keep track of government securities that underpin the program.
Medicare is a government-funded health insurance program for those 65 and older, disabled people, and people with certain health conditions specified by the government.﻿﻿﻿﻿ The other parts of Medicare—Parts B, C, and D—pay for healthcare services not covered by the hospital insurance trust fund (doctor visits, lab tests, and prescription drugs) and are funded through premium payments from beneficiaries.
The hospital insurance trust is funded by revenue from Social Security benefits and payroll taxes from all workers in the United States, not just from beneficiaries.﻿﻿﻿﻿ The Federal Hospital Insurance Trust Fund is also known as Part A of Medicare, the health insurance program for people aged 65 and older in the United States. The Federal Hospital Insurance Trust Fund is Part A of Medicare and covers hospital stays, hospices, and skilled nursing facilities. Given changing demographics and regulations, the trust fund is expected to be depleted by 2026 and, from that point forward, retirees will no longer receive full benefits from the program.

Hospital Insurance Trust Fund

A health reimbursement arrangement (HRA) is an employer-funded plan that reimburses employees for medical expenses and, sometimes, insurance premiums.

New Health Coverage Options for Employers and Employees

Health Reimbursement Arrangements (HRAs) for Small Employers

What's an individual coverage Health Reimbursement Arrangement (HRA)?

Health Savings Accounts and Other Tax-Favored Health Plans

Additional Relief For Coronavirus Disease (COVID-19) Under Cafeteria Plans

Table of Contents
What Is a HRA? Pros
Can be used to pay for medical and dental expenses such as prescription medications, an annual physical exam, and birth control pills
Can be used to pay for individual health insurance with pretax dollars
Reimburses employees after they've paid for certain medical expenses and insurance premiums
Can't be used for costs that aren't deemed necessary, such as teeth whitening, funeral services, or non-prescription medication
Is set up by the employer, who decides how much money goes into the plan
Can't withdraw funds first, then pay expenses; they must pay first and then wait to get reimbursed How a HRA Works
Types of HRAs
Benefits of HRAs
Limitations of HRAs
HRAs vs. Other Arrangements
Special Considerations
The Bottom Line
A health reimbursement arrangement (HRA) is an employer-funded plan that reimburses employees for qualified medical expenses and, in some cases, insurance premiums. An employee who uses up all the allocated funds in the HRA before year-end will have to cover any subsequent health bills out-of-pocket or with the funds in a flexible spending account (FSA), also known as a flexible spending arrangement, when available, or a health savings account (HSA) for employees who have a high-deductible health plan (HDHP). A health reimbursement arrangement (HRA) is a benefit used to pay employees back in tax-free money for certain qualified medical expenses and health coverage premiums.

Health Reimbursement Arrangement (HRA)

An HSA custodian is any bank, credit union, insurance company, brokerage, or other IRS-approved organization that offers health savings accounts.

H.R.1 - Medicare Prescription Drug, Improvement, and Modernization Act of 2003

An HSA custodian is any bank, credit union, insurance company, brokerage, or other Internal Revenue Service (IRS)-approved financial institution that offers health savings accounts (HSAs). HSA custodians also charge many of the same fees that checking accounts charge, such as insufficient funds fees, account closure fees, and stop payment fees. An HSA custodian or administrator holds HSA assets in a secure HSA account. Your choice of HSA custodian is important because the interest you earn, the fees you pay, and the investment options available can have a significant impact on your HSA balance over time. An HSA differs from a flexible spending account (FSA), which is an employer-sponsored account that allows employees to set aside pretax dollars to pay for eligible health care expenses.

HSA Custodian

A Health Savings Account (HSA) is a tax-free savings account that can be used to pay for medical expenses not covered by high-deductible health plans.

HSA Contribution Limits and Other Requirements

Publication 969: Health Savings Accounts and OtherTax-Favored Health Plans

Publication 502: Medical and Dental Expenses

2021 FSA Contribution Cap Stays at $2,750, Other Limits Tick Up

Table of Contents
Health Savings Account (HSA) Any excess contributions made to an HSA incur a 6% tax and are not tax-deductible.
Distributions from an HSA are tax-free provided the funds are used for qualified medical expenses as outlined by the IRS.﻿﻿ Distributions used for medical expenses that are covered under the HDHP plan are included in determining if the HDHP’s deductible has been met.
You can use the money in your HSA to invest in stocks and other securities, potentially allowing for higher returns over time.
An obvious drawback is the limits on eligibility. No tax is levied on contributions to an HSA, on the HSA’s earnings, or on distributions used to pay for qualified medical expenses. Insurance premiums don’t count as a qualified medical expense unless the premiums are for Medicare or other health care coverage (provided you are 65 years of age or older); for health insurance when receiving health care continuation coverage (COBRA); for coverage when receiving unemployment compensation, or for long-term care insurance, subject to annually adjusted limits. They are often referred to as triple tax-advantaged because contributions are not subject to tax, the money can be invested and grow tax-free, and withdrawals are not taxed as long as they are used for qualified medical expenses.

Health Savings Account (HSA)

Intellectual Property Rights (Biotechnology) give companies a way to protect exclusive use of pharmaceuticals, brand names and more. 

Biotechnology intellectual property rights are the legal ownership of an interest in a patent, trademark or trade secret. Other health care companies use patents to protect their intellectual property rights to devices such as splints, prostheses, vision testing machines and the computer systems used in health care management. Biotechnology intellectual property rights provide health care companies with a means to protect their claim to and ownership of these assets through common law, state law or federal law. As another example, biotechnology companies use patents to protect their intellectual property rights to drug delivery devices. In health care, intellectual property rights give their owners exclusive use of pharmaceuticals, brand names and more.

Biotechnology Intellectual Property Rights

Issue-age policy refers to healthcare insurance whose premium rate is dependent on the age of the individual who purchases it.

An issue-age policy is a healthcare policy that has a premium rate that is dependent on the age of the individual who purchases it. Insurance providers who underwrite issue-age policies will tie the cost of the policy to an individual's age because, statistically, older policyholders are more likely to require medical treatment. An issue-age policy does not increase in price after purchase, even as the policyholder ages, although premium payments may increase with the cost of healthcare services due to many factors. An issue-age policy is a healthcare policy that has a premium rate that is dependent on the age of the individual who purchases it. An issue-age policy is a healthcare policy with a premium rate that is dependent on the age of the policyholder.

Issue-Age Policy

Lifetime Reserve Days is the number of hospital days that an insurance policy will cover above the number of days allotted per benefit period. 

Update to Medicare Deductible, Coinsurance and Premium Rates for Calendar Year (CY) 2020

Lifetime reserve days are the number of hospital days that an insurance policy will cover above the number of days allotted per benefit period. The first sixty days of hospital stay have no co-pay, days sixty-one to ninety have a daily co-pay of $352 (in 2020), and over ninety days have a $704 co-insurance per lifetime reserve day used. For example, a patient who expects to only need one lifetime reserve day during a particular hospital stay may want to pay the cost of the one additional day out of pocket, if the cost of that day is close to the cost of the lifetime reserve days. For example, if a patient stays in the hospital or nursing facility for 100 days but is only allotted 90 days per benefit period, the patient will have to use 10 lifetime reserve days. Lifetime reserve days are the number of days of hospital stay that an insurance policy covers beyond the number of days allotted per benefit period.

Lifetime Reserve Days

A limited purpose flexible spending arrangement (LPFSA) is a medical savings plan, for use with a health saving account (HSA), to pay dental and vision expenses.

The term "limited purpose flexible spending arrangement" (LPFSA) refers to a savings plan that can be used with a health savings account (HSA). Some employers also allow plan participants to use LPFSA funds to pay for qualified medical expenses once they meet their health insurance deductibles. A limited purpose flexible spending account works just like a regular flexible spending account in that they are only accessible to individuals whose employers make them available. A limited purpose flexible spending arrangement is a savings plan for dental, vision, and other expenses not covered by health plans. That's because the arrangement is reserved for the payment of dental and vision expenses, as well as other costs incurred in a high-deductible health plan (HDHP) after the plan holder meets the deductible.