The Employers’ Prescription for Employee Protection Toolkit: Appendix

Glossary of Terms

Benefit design

Benefit design is the set of rules that structure a health insurance plan and determine how healthcare services can be accessed under coverage. This includes decisions about how individuals can gain access to services, providers, treatments and medications; which will be covered by the health plan; and what amount of cost-sharing individuals will need to cover as out-of-pocket expenses through deductibles, copayments or coinsurance.

Biologic drug / biologic

Biologic drugs or biologics are derived from living organisms and produced in living cells (i.e. yeast, bacterial, human tissue or plasma cells). A piece of DNA is inserted into a living cell so it can instruct the cell to produce a specific molecule, such as a protein. Those molecules are then isolated to become the biologic drug’s active ingredient. Contrast this with traditional medications, which are smaller molecules created from specific chemicals by using a synthesis process. Biologics help the body “manufacture” substances that boost the immune system’s response and, in the case of some cancer treatments, target cancer cells.

Biosimilar drug / biosimilar

A biosimilar drug, or biosimilar, is a medicine that is very close in structure and function to a biologic drug (see definition). Biosimilars are developed using a comparable, but not identical, biologic agent and are marketed at a lower cost than brand-name biologics. According to the FDA, they are “a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product.”

Claim

A claim is a formal request for payment after services that an insured individual or their healthcare provider submits to the insurer. The insurer processes and reviews the claim for completeness, accuracy and coverage eligibility. If the claim is determined to be covered, the insurer pays their required portion. If the claim is denied, the patient is responsible for the cost and may choose to pay or file an appeal (i.e. request that the insurer reevaluate their decision and provide payment).

Closed formulary - see “Formulary”

Coinsurance

Coinsurance is a portion or percentage of a healthcare service cost that an insured individual is required to pay under their health plan. For example, if an individual's coinsurance for prescriptions is 20%, they pay 20% of a drug's cost and the insurance plan pays 80%, together covering 100% of costs. The higher the coinsurance rate, the higher an individual's out-of-pocket costs. An individual may be required to reach a deductible (a pre-set amount of out-of-pocket expenses) before the health plan covers their portion of coinsurance.

Copayment (also: copay)

A fixed amount ($20, for example) a plan enrollee pays for a covered prescription or healthcare service after paying their initial deductible. The health plan pays the remainder of the cost for that prescription or service (e.g. $100 prescription - $20 copay by enrollee = $80 paid by health plan). (See also “Deductible”)

Copay accumulator program

Copay accumulator programs exclude from an individual's out-of-pocket spending total any prescription copay costs covered by drug manufacturer coupons, non-profit organizations and other sources of outside support. Previously, the dollar amount covered by copay support was counted toward the individual's deductible and annual out-of-pocket spending maximum, helping them reach these totals sooner. There is no standard industry term for copay accumulator programs: other terms used by insurers include “coupon adjustment,” “variable co-payment,” “out-of-pocket maximum calculation process,” “pharmacy coupon adjustment changes,” “Out of Pocket Protection Program,” “Benefit Plan Protection Program” or “Copay Card True Program Accumulation.”

Similarly, a copay maximizer program does not count copayment financial assistance toward the patient’s deductible and out-of-pocket maximum. The difference is that maximizer plans apply the value of the coupon or charitable support evenly throughout the benefit year, rather than using it up and then abruptly shifting all costs to the patient, as the accumulator does. A patient might still pay more overall than they did with copay support, but much less than they would under a copay accumulator.

Copay accumulator example: an individual has a copay of $500 for a specialty drug and a deductible of $1000. Thanks to a coupon from the drug's manufacturer, the individual only pays $25 to fill a prescription and the coupon covers the other $475. Previously, the full $500 copay would be credited to the individual's out-of-pocket spending and they would be $500 away from reaching the deductible. Under a copay accumulator, only $25 is counted toward the individual's out-of-pocket spending and they are still $975 away from reaching the deductible; the health plan collects the $475 covered by the coupon, but does not count that amount toward the individual’s out-of-pocket spending.

Deductible

A deductible is the amount an insured individual pays each year for most eligible services or medications before the health plan begins to share in the cost of covered services. For example, if an individual has a $2,000 yearly deductible, they'll need to pay the first $2,000 of total eligible healthcare costs before the plan helps to pay. Deductibles for family coverage and individual health plan coverage are different. Some health plans include separate medical and prescription drug deductibles.

Financial non-adherence

Financial non-adherence is when patients do not follow their prescribed treatment plan due to the costs. Examples include a patient who doesn’t fill a prescription, who delays or stops getting refills for a medication, or who alters the prescribed dosage to stretch a prescription due to high out-of-pocket costs. Higher rates of financial non-adherence are associated with restrictive drug benefits and other UM practices that increase out-of-pocket costs. Because financial non-adherence disrupts treatment, it can lead to worse health outcomes and higher expenses later when more intensive or emergency care is needed.

Financial toxicity

Financial toxicity is an umbrella term describing all the financial side effects of treating cancer, including direct costs (i.e. out-of-pocket expenses related to medical services and prescription drugs) and indirect costs (e.g. transportation to appointments, child care, new dietary needs and/or healthy groceries, potential job loss, etc.). Benefit design that increases cost-sharing for individuals, such as higher deductibles, higher copay or coinsurance rates, can worsen financial toxicity.

First-line therapy / first-line treatment (also: induction therapy, primary therapy, primary treatment)

A first-line therapy is the first treatment given for a disease. It is often part of a standard sequence of treatments, such as surgery followed by chemotherapy and radiation. When not used as part of a sequence, it is the treatment that is expected to provide the best results with the fewest number of side effects for most patients.

Formulary

The formulary is a list of drugs approved for coverage by a health plan. Insurers and PBMs arrange formulary drugs into tiers based on their price and clinical value; patients typically pay a higher copay or coinsurance rate to access drugs in higher tiers. Along with brand-name drugs, formulary tiers also incorporate generics and biosimilars—lower-cost drugs that provide the same benefits as their brand-name counterparts. In an “open formulary,” the plan sponsor pays a portion of the cost for all drugs, whether or not they are included on the preferred list. In a “closed formulary,” the health plan will only cover drugs listed on the formulary. Insurers and PBMs control which drugs are included and excluded from the formulary, a process often influenced by cash-back rebates from drug manufacturers (see “Rebates”). In very restricted formularies, they may approve just one option per drug class. Non-formulary drugs are not covered and enrollees must pay the full price to access them, unless approved through a formulary exception process (an appeal submitted by a patient and their prescribing clinician).

Generic drug / generic

A generic drug is a medication created to be the same as an existing approved brand-name drug in dosage form, safety, strength, route of administration, quality and performance characteristics, but marketed at a lower price. The Hatch-Waxman Act was written into law in 1984 to promote price competition through generic drugs once a brand-name drug’s patent protection runs out. Generic medicines work the same as brand-name medicines; however, as with any drug, some patients may experience side effects or other issues with generics and better tolerate the brand-name version.

High Deductible Health Plan

(HDHP) Compared to standard health plans, enrollees in HDHPs must pay a higher deductible; in exchange, their monthly premiums are typically lower. For 2021-22, the IRS defines a HDHP as one having a deductible of at least $1,400 for an individual or $2,800 for a family. An HDHP’s total annual out-of-pocket expenses for in-network care (including deductibles, copayments and coinsurance) cannot exceed $7,000 for an individual or $14,000 for a family. While the lower premiums may be appealing, patients with serious illnesses and chronic conditions can be burdened with major out-of-pocket expenses before the plan covers any part of their healthcare costs. To buffer these expenses, HDHPs can be paired with a health savings account (HSA). Enrollees and their employers can make pre-tax contributions to the HSA that can be spent on out-of-pocket healthcare costs. (See also “Deductible”)

ICER

ICER is an acronym used for the Institute for Clinical and Economic Review, a private research organization; the same acronym is also used for the organization's value assessment framework, the Incremental Cost-Effectiveness Ratio. As an organization, ICER evaluates the clinical and economic value of prescription drugs, medical tests, devices and health system delivery innovations. ICER’s value assessment framework is used to compare treatment options by calculating costs vs. health benefits. ICER typically uses a pre-set "cost-effectiveness threshold": for example, a cost-to-benefit calculation of no more than $100,000 per year for a treatment. Some health plans and pharmaceutical benefit managers use these calculations to make coverage decisions. CancerCare and other leading medical organizations have criticized ICER’s practices, citing its reliance on the discriminatory QALY standard (see “QALY”), its “one-size-fits-all” frameworks, lack of transparency and failure to incorporate real-world perspectives from patients, caregivers and physicians.

Non-adherence - see “Financial non-adherence”

Non-medical switching

Non-medical switching is when changes are made to a patient’s approved treatment for any reason other than side effects, efficacy or adherence. Non-medical switching can occur when an insurer eliminates coverage for a prescribed medication or adds policies that increase out-of-pocket expenses for a prescribed medication, pushing patients to switch to an alternate treatment preferred by the insurer. Non-medical switching may also occur when insurers offer pharmacists or patients a financial incentive to switch to a preferred drug.

Open formulary - see “Formulary”

Out-of-pocket costs / Out-of-pocket maximum

Out-of-pocket costs are a patient’s expenses for services, treatments and prescriptions that aren't reimbursed by insurance. Out-of-pocket costs include deductibles, coinsurance and copayments for covered services, plus all healthcare costs that aren't covered. Some plans place a cap on how much a patient has to pay out of pocket each year. Once a patient reaches the out-of-pocket maximum, the insurer will pay 100% of all covered healthcare expenses for the rest of the plan year.

Payers

Payers is a broad term used in the healthcare industry to refer to any organization that pays for healthcare services and may also set service rates, collect payments and process claims. While payers typically refers to health plan insurers, Medicare, and Medicaid, it can also refer to self-insured employers who provide health plan coverage.

Personalized medicine

Personalized medicine is healthcare informed by and tailored to a patient’s unique genetics and circumstances. An individual's genetics and background can be used to guide decisions about testing, prevention, diagnosis and treatment. In cancer care, precision or targeted treatments use a cancer's genetic profile to match it with a specific drug for improved outcomes.

Pharmacy benefit managers (PBMs)

Pharmacy benefit managers (PBMs) manage prescription drug benefits on behalf of many health plans and self-insured employers. PBMs aim to control drug spending across several channels and through a variety of utilization management tools: 1) they create the list of drugs covered by a health plan and determine how much patients must pay to access preferred vs. non-preferred drugs (see “Formulary”); 2) they negotiate directly with drug manufacturers on pricing (see “Rebates”); and 3) they manage relationships with pharmacies to further coordinate patients’ access to drugs and what they pay (see “Specialty pharmacy”).

Pre-authorization (also: prior authorization, prior approval, precertification, PA)

Pre-authorization is a UM policy that requires certain services, treatments or prescriptions be submitted to the insurer for review and deemed medically necessary before a patient can receive that care. An insurer may deny coverage if pre-authorization is not properly secured; granting pre-authorization, however, does not guarantee an insurer will pay for treatment. Securing pre-authorization is often a time-consuming process for patients and healthcare providers alike and can lead to delays in treatment.

Premium

A premium is a set fee paid for health insurance every month. The premium is paid separately from other expenses a patient may have for healthcare services and prescriptions, such as deductibles, copayments and coinsurance. Employers often cover a portion of the premium and employees cover the rest.

Presenteeism

An employee is physically present in the workplace, but their productivity is reduced due to feeling unwell and/or disruptions, such as lengthy calls with their insurer to appeal a coverage denial. Employees who are caregivers for ill family members may experience presenteeism as well.

QALY

QALY stands for “Quality-Adjusted Life Year” and is an older economic tool used to quantify the value of a treatment by determining how its cost corresponds to the potential benefit. The QALY model assigns comparative values to different treatments based on how long it would prolong life and how much it would improve quality of life, essentially creating a formula of “quality of life x quantity of life.” The QALY has drawn criticism and prohibitions under several federal statutes due to its narrow definition of “perfect health” that devalues and discriminates against people based on age, disabilities and chronic conditions, and fails to acknowledge diversity among patients and their different treatment needs and goals.

Rebates

Rebates are cash-back refunds paid to the pharmacy benefit manager (see “Pharmacy benefit managers”) by the drug manufacturer after a drug is sold—this way, the PBM’s final net price for the drug ends up being lower than the original list price. PBMs pass the rebates on to health plans; however, their contracts often allow them to keep a portion. High-volume rebates are a major source of revenue for many PBMs. PBMs negotiate rebates with drug manufacturers in exchange for a preferred lower-tier spot for a drug on their formulary, which offers wider use by patients.

Specialty pharmacy

Specialty pharmacies focus on medications for complex, chronic or rare medical conditions, including cancer. These drugs may require extra care to safely handle and dispense, or on-going patient monitoring. For cancer patients, specialty pharmacies can help coordinate the shipment of chemotherapeutics and the logistics of how they’ll be administered. A health plan may require that insured individuals use a specific specialty pharmacy. Some specialty pharmacies are now controlled by insurers and pharmacy benefit managers (see “Pharmacy benefit managers”), which has raised concerns about a conflict of interest when it comes to managing patients' out-of-pocket costs.

Step therapy

Step therapy, otherwise known as a “fail-first” protocol, requires patients to try one or more treatments from their health plan’s formulary (i.e. list of approved drugs; see “Formulary”) and demonstrate it fails to improve their condition before the insurer will cover a doctor-prescribed course of treatment. Often, patients are first required to use treatments that come at a cost-savings to the insurer before being approved for higher-cost prescriptions or, in some cases, prescriptions not included in the formulary.

Utilization management

Utilization management (UM) is an umbrella term for cost-containment techniques used to evaluate healthcare services and determine whether they are medically necessary and appropriate for patients—and ultimately, whether a health insurance provider should pay for them. UM sets the rules by which insurers restrict or deny coverage for care. At its best, UM helps to catch issues, weeds out unproven treatments, balances physicians’ decisions and reduces costs while delivering quality care. At its worst, UM creates administrative snarls and costly out-of-pocket expenses for patients and can stand between patients and their physicians when setting the best personal course of treatment.

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