340B
The 340B Drug Pricing Program is a federal program requiring participating manufacturers to offer outpatient drugs at discounted prices to eligible healthcare organizations, such as certain safety-net hospitals and clinics. The savings are meant to help these providers serve vulnerable patients. 340B status can affect contract pharmacy arrangements, program design, and how manufacturers manage patient assistance and distribution.
Adherence; persistence
Adherence is how closely a patient takes a medication as prescribed, including the correct dose and timing. Persistence is how long a patient continues therapy without a gap or discontinuation. Manufacturers and payers track both because missed doses and early stopping can reduce treatment benefit, and patient support programs often focus on cost, education, and reminders to improve them.
Adverse event reporting; pharmacovigilance
An adverse event is any undesirable medical occurrence in a patient using a medication, whether or not it is caused by the product. Pharmacovigilance is the science of detecting, assessing, and preventing such events. Manufacturers must report certain adverse events to regulators, so patient support programs train staff to recognize and forward them promptly.
Appeal; peer-to-peer review; external review
An appeal is a formal request asking a health plan to reverse a coverage denial. Appeals often move from an internal review, which can include a peer-to-peer discussion between the prescriber and a plan physician, to an independent external review. Strong appeals pair the prescriber's clinical rationale with documentation addressing the plan's stated reason for denial.
Benefits verification (BV) vs. benefits investigation (BI)
Benefits verification (BV) confirms whether a patient's insurance is active and what basic coverage applies. Benefits investigation (BI) goes further, identifying prior authorization requirements, step therapy, cost-sharing, and site-of-care rules for a specific product. Many programs use the terms interchangeably, but BI is the more detailed analysis that guides next steps.
Bridge program; Quick Start program
A bridge program supplies a manufacturer's therapy temporarily when a patient's coverage is delayed or interrupted, such as during prior authorization or an appeal. A Quick Start program provides an initial supply so treatment can begin while coverage is confirmed. Both aim to prevent gaps in therapy and are typically offered at no charge to eligible patients.
Budget impact model
A budget impact model estimates how adopting a new treatment would change a payer's spending over a short period, usually one to five years. It considers eligible patient numbers, treatment costs, and offsets such as avoided care. Payers use budget impact alongside clinical evidence and cost-effectiveness, and manufacturers often include one in a value dossier.
Buy-and-bill
Buy-and-bill is a model in which a provider purchases a drug, administers it to the patient, and then bills the patient's medical benefit for reimbursement. It is common for infused and injected therapies given in clinics or hospitals. Providers carry the financial risk of nonpayment, so reimbursement support is important to adoption.
Case management
Case management in patient access is the coordinated tracking of an individual patient's enrollment from referral through therapy start and ongoing support. A case manager monitors benefits checks, authorizations, financial assistance, and pharmacy handoffs, communicates with the patient and prescriber office, and resolves obstacles so the process moves forward with one accountable contact.
Cell and gene therapy
Cell therapy uses living cells to treat disease, and gene therapy modifies or replaces a patient's genes. Many are one-time treatments with very high upfront cost, delivered at specialized treatment centers. Access can involve unique challenges such as site qualification, coverage review, travel support, and outcomes-based payer agreements, making coordinated case management especially important.
Claims denial management; modifier
Claims denial management is the process of finding why a claim was rejected or denied, correcting errors, resubmitting, and appealing when appropriate. A modifier is a two-character code added to a CPT or HCPCS code to give extra information about a service, such as how or where it was performed. Missing or incorrect modifiers are a common cause of denials.
Clinical Laboratory Fee Schedule (CLFS)
The Clinical Laboratory Fee Schedule (CLFS) is the Medicare fee schedule that sets payment rates for clinical diagnostic laboratory tests. Rates are tied to CPT or PLA codes and are updated under federal law. For diagnostics manufacturers and laboratories, a test's code and its CLFS rate strongly influence Medicare payment and often inform how commercial payers set their own rates.
Companion diagnostic; point-of-care test
A companion diagnostic is a test that provides information essential for the safe and effective use of a specific therapy, such as identifying patients likely to benefit. A point-of-care test delivers results at or near where the patient is seen, often within minutes, rather than at a central laboratory. Both raise coding, coverage, and reimbursement questions for manufacturers.
Copay accumulator; copay maximizer
A copay accumulator is a health plan policy that does not count manufacturer assistance toward a patient's deductible or out-of-pocket maximum. A copay maximizer sets the patient's cost share to the full amount of assistance available, drawing it down across the plan year. Both can leave patients owing more later, and rules vary by plan and state.
Copay assistance program
A copay assistance program is a manufacturer-funded benefit that reduces a commercially insured patient's out-of-pocket cost for a prescribed product, typically through a copay card or similar mechanism. Eligibility rules apply, and these programs generally cannot be used by patients enrolled in federal healthcare programs such as Medicare or Medicaid.
Coverage strategy
A coverage strategy is a manufacturer's plan for securing favorable payer coverage and reimbursement for a product. It identifies priority payers, expected utilization management hurdles, the evidence and value messages payers need, and the coding and benefit pathway the product will follow. A strong strategy anticipates barriers before launch rather than reacting to denials.
Deductible; coinsurance; copay; out-of-pocket maximum
A deductible is the amount a patient pays for covered care or drugs each plan year before insurance begins paying. A copay is a fixed amount per service or fill, and coinsurance is a percentage of the cost. The out-of-pocket maximum is the most a patient pays for covered services in a plan year, excluding premiums.
Denial; explanation of benefits (EOB)
A denial is a payer's decision not to cover or pay for a drug, device, or service, often because of missing information or unmet coverage criteria. An explanation of benefits (EOB) is a statement from the insurer showing what was billed, what the plan paid, and what the patient may owe. An EOB is not a bill.
DMEPOS / durable medical equipment
DMEPOS stands for durable medical equipment, prosthetics, orthotics, and supplies. These items are used in the home or outside a physician's office and are billed using HCPCS Level II codes. DME coverage rules, supplier requirements, and payment methods differ from pharmacy and standard medical benefits, so manufacturers often need dedicated reimbursement strategy.
e-consent; digital intake
E-consent captures a patient's permission electronically, using a secure digital signature or recorded verbal consent instead of paper forms. Digital intake is the online or system-based submission of patient referrals and enrollment data. Together they speed enrollment, reduce errors from incomplete paperwork, and create an auditable record that consent is on file.
EHR integration
EHR integration connects a patient access program or hub platform to a prescriber's electronic health record, allowing enrollment, benefits checks, and prior authorization to start from within the prescribing workflow. It reduces re-entry of information and paper forms and can speed therapy starts. Capabilities vary by EHR vendor, practice, and program.
Electronic benefits verification (eBV)
Electronic benefits verification (eBV) uses electronic connections to payers, pharmacy benefit managers, or data networks to retrieve a patient's insurance eligibility and coverage details within minutes. It can return information such as plan status, copay, and prior authorization requirements. When electronic data is incomplete, specialists may follow up directly with the payer to confirm details.
Electronic prior authorization (ePA)
Electronic prior authorization (ePA) submits and tracks PA requests digitally, often within a prescriber's electronic health record or a portal, rather than by fax or phone. ePA can reduce manual rework and speed payer decisions, though some plans and benefit types still require manual submission or added clinical documentation.
Fee schedule; ASP; WAC
A fee schedule is a list of payment amounts a payer sets for covered services or products. Average sales price (ASP) is a manufacturer-reported price that Medicare uses to set payment for many Part B drugs. Wholesale acquisition cost (WAC) is a manufacturer's list price to wholesalers, before discounts. These are different prices and are not what a patient pays.
Field reimbursement manager (FRM) / Access & reimbursement manager (ARM)
A field reimbursement manager (FRM), also called an access and reimbursement manager (ARM), is a specialist who educates provider offices on coverage, coding, billing, and payer processes for a product. They do not make clinical or promotional recommendations. Their role is to help practices navigate reimbursement so eligible patients can obtain therapy.
Formulary exception / medical exception
A formulary exception, also called a medical exception, is a request asking a health plan to cover a drug that is not on its formulary, or to waive a restriction such as step therapy or a quantity limit. The prescriber usually must show that preferred alternatives are ineffective or unsuitable for the patient. Plans set their own review procedures.
Formulary; tier; specialty tier
A formulary is a health plan's list of covered drugs. Drugs are grouped into tiers that set patient cost-sharing, with higher tiers generally costing more. A specialty tier is typically the highest tier, used for high-cost drugs, and often carries coinsurance. Formulary placement and tier strongly influence whether and how affordably patients can obtain a therapy.
Gross-to-net
Gross-to-net describes the difference between a drug's list price and the net revenue a manufacturer receives after rebates, discounts, fees, and other adjustments. The gap, sometimes called the gross-to-net bubble, reflects payer and pharmacy contracting. Understanding it helps manufacturers evaluate access strategies, since coverage often depends on contracts that lower net price.
HCPCS Level II
HCPCS Level II is a national coding system maintained by the Centers for Medicare & Medicaid Services. Its codes, a letter followed by four digits, identify products, supplies, and services not described by CPT codes, such as drugs and biologicals, durable medical equipment, and ambulance services. Correct codes are essential for claims processing and payment.
Health technology assessment (HTA)
Health technology assessment (HTA) is a structured evaluation of a treatment's clinical effectiveness, safety, and often cost-effectiveness, used to inform coverage and pricing decisions.
HEOR (health economics and outcomes research)
Health economics and outcomes research (HEOR) generates evidence on the clinical, economic, and patient-reported value of treatments. It includes cost-effectiveness analysis, budget impact modeling, and real-world outcomes studies. Manufacturers use HEOR to support payer coverage decisions, pricing and contracting, and communication of a product's value to decision makers.
HIPAA
HIPAA, the Health Insurance Portability and Accountability Act, sets national standards for protecting individuals' health information. Hubs and other service providers handling patient information for manufacturers must follow its privacy and security rules, including limits on how information is used and shared, safeguards for data, and requirements for patient authorization where applicable.
Hub services
Hub services are outsourced patient access programs run on behalf of a treatment manufacturer. A hub enrolls patients, verifies insurance benefits, supports prior authorization and appeals, connects patients to financial assistance, coordinates with pharmacies, and follows up to help patients start and stay on therapy.
ICD-10-CM
ICD-10-CM is the diagnosis coding system used in the United States to report a patient's conditions, symptoms, and reasons for care. Maintained by the National Center for Health Statistics, it replaced ICD-9-CM in October 2015. Diagnosis codes on a claim help payers determine whether a drug, device, or test meets coverage criteria.
IDN; GPO
An integrated delivery network (IDN) is a group of hospitals, clinics, and related providers operating under common ownership or management. A group purchasing organization (GPO) negotiates supplier contracts on behalf of many healthcare members to secure lower prices. For manufacturers, IDN and GPO decisions can determine whether a product is available across many facilities.
Infusion therapy; self-administered drug
Infusion therapy delivers medication directly into the bloodstream, usually through an IV, over a set period at a clinic, hospital, infusion center, or sometimes at home. A self-administered drug is one a patient typically gives themselves, such as an injection or oral therapy. The difference often determines whether coverage falls under the medical or pharmacy benefit.
J-code; miscellaneous/unclassified drug code
A J-code is a HCPCS Level II code beginning with the letter J that identifies many drugs and biologicals that are typically not self-administered, such as injections and infusions. Miscellaneous or unclassified drug codes are used when no specific code exists yet, usually requiring added documentation on claims until a permanent code is assigned.
Launch readiness; launch roadmap
Launch readiness is the preparation that determines whether a product can reach patients smoothly at approval. It typically covers payer strategy, coding and billing readiness, hub and patient support design, field team training, and distribution planning. A launch roadmap sequences these workstreams with timelines and owners, ideally beginning well before regulatory approval.
Letter of medical necessity (LMN)
A letter of medical necessity (LMN) is a document from a prescriber explaining why a specific treatment is medically necessary for a patient. It typically summarizes the diagnosis, prior therapies tried, clinical rationale, and supporting evidence. Payers may request an LMN during prior authorization, appeals, or medical exception reviews, and its quality can influence the coverage decision.
Local Coverage Determination (LCD); National Coverage Determination (NCD)
A National Coverage Determination (NCD) is Medicare's nationwide decision on whether an item or service is covered. A Local Coverage Determination (LCD) is issued by a Medicare Administrative Contractor and applies within its jurisdiction. Both set conditions for Medicare coverage, and commercial payers often reference them when writing their own policies.
Market access
Market access is the strategy and execution involved in helping appropriate patients obtain prescribed therapies, medical devices, and diagnostic services by addressing coverage, coding, reimbursement, affordability, and delivery barriers. It can include payor engagement, evidence and value communication, pricing and contracting strategy, provider reimbursement support, and patient support programs. Market access planning begins before launch and evolves throughout a product’s lifecycle.
Maximum Fair Price (MFP); Inflation Reduction Act
The Inflation Reduction Act of 2022 lets Medicare negotiate prices for certain high-spend drugs. The resulting negotiated price is called the Maximum Fair Price (MFP). MFPs first took effect in 2026 for an initial group of drugs, with additional drugs in January 2027. An MFP is a price for Medicare, not a patient's copay, which still depends on plan benefit design.
Medical benefit vs. pharmacy benefit
The pharmacy benefit covers drugs dispensed by a pharmacy, usually self-administered and managed by a pharmacy benefit manager. The medical benefit covers services and products administered or billed by a provider, such as infusions and devices. Which benefit applies determines billing codes, prior authorization rules, patient cost-sharing, and how a product reaches the patient.
Medical policy / coverage policy
A medical policy, also called a coverage policy, is a health plan's written document stating when it covers a specific drug, device, test, or service. It defines clinical criteria, required documentation, and limits. Policies change over time, so tracking them and engaging payers helps manufacturers anticipate coverage barriers and support patient access.
Medicare Administrative Contractor (MAC)
A Medicare Administrative Contractor (MAC) is a private company that processes Medicare fee-for-service claims and administers Medicare coverage and payment rules within a geographic jurisdiction. MACs issue Local Coverage Determinations and provide provider enrollment and education. The MAC covering a provider determines which local coverage policies apply to a device, test, or service.
National Drug Code (NDC)
A National Drug Code (NDC) is a unique three-segment number that identifies a drug product by its labeler, product, and package size. It appears on drug packaging and listing records. Payers and pharmacies use NDCs to process claims, and providers often report them alongside HCPCS codes when billing for physician-administered drugs.
New Technology Add-on Payment (NTAP); pass-through status
The New Technology Add-on Payment (NTAP) is additional Medicare payment for certain new technologies used in inpatient hospital stays, when standard payment may not cover their cost. Transitional pass-through status is a similar temporary payment for qualifying new drugs, biologicals, and devices in hospital outpatient settings. Both can support early access to innovative products while claims data accumulate.
Non-commercial pharmacy
A non-commercial pharmacy dispenses a manufacturer's medication outside the standard insurance billing channel, typically at no charge to the patient. It is commonly used for patient assistance programs, bridge supply, quick start, and replacement programs. Because no commercial claim is billed, these pharmacies operate under manufacturer-defined eligibility rules and strict compliance requirements.
Nurse educator; patient navigator
A nurse educator is a registered nurse who provides non-promotional education to patients about their condition, treatment, and administration, such as injection training, and does not replace the prescriber's guidance. A patient navigator helps patients through non-clinical hurdles including insurance, financial assistance, and scheduling. Both roles support adherence and a smoother start to therapy.
Orphan drug; rare disease
In the United States, a rare disease is generally defined as one affecting fewer than 200,000 people. An orphan drug is a medicine developed to treat such a condition and may receive incentives under the Orphan Drug Act. Because patient populations are small and care is specialized, rare disease therapies often rely on high-touch access support.
Patient assistance program (PAP) / free goods
A patient assistance program (PAP) provides a manufacturer's medication at no or low cost to eligible patients, often those who are uninsured, underinsured, or facing financial hardship. Supply is commonly called free goods and is typically dispensed through a non-commercial channel. Eligibility usually depends on income, insurance status, and prescriber documentation.
Patient consent / HIPAA authorization
Patient consent is a patient's documented permission for a program to use and share their health information to provide support services. A HIPAA authorization is a specific written permission covering how protected health information may be used and disclosed. Programs generally need valid authorization on file before verifying benefits or contacting a patient's payer, pharmacy, or prescriber.
Patient support program (PSP)
A patient support program (PSP) is a manufacturer-sponsored set of services that helps patients start and stay on a prescribed therapy. Services typically include insurance navigation, financial assistance, education, and nurse or navigator support. Hubs often operate PSPs, and the terms overlap, though PSP names the program and hub names the operating partner.
Payer; commercial; Medicare; Medicaid
A payer is any organization that pays for healthcare, including insurers, employers, and government programs. Commercial coverage is private insurance, often through an employer. Medicare is the federal program for people 65 and older and some younger people with disabilities. Medicaid is a joint federal-state program for eligible low-income individuals. Each follows different coverage and cost-sharing rules.
Pharmacy benefit manager (PBM)
A pharmacy benefit manager (PBM) is a company that administers prescription drug benefits for health plans, employers, and other payers. PBMs build formularies, negotiate with manufacturers and pharmacies, process claims, and manage utilization controls such as prior authorization.
PLA code; MAAA code
Proprietary Laboratory Analyses (PLA) codes are CPT codes that identify specific proprietary lab tests, often assigned to a single laboratory or manufacturer. Multianalyte Assays with Algorithmic Analyses (MAAA) codes describe tests that combine multiple biomarkers using an algorithm. These codes help payers identify tests for coverage, though payment varies by payer.
Prescription abandonment
Prescription abandonment occurs when a patient is prescribed a medication but never picks it up or starts treatment. Common causes include high out-of-pocket cost, prior authorization delays, coverage denials, and confusion about next steps. Access programs aim to reduce abandonment by resolving cost and coverage barriers early and keeping patients informed during onboarding.
Prior authorization (PA)
Prior authorization (PA) is a health plan requirement that a prescriber obtain approval before a medication, device, or service is covered. The plan reviews clinical information to confirm medical necessity under its policy. Without an approved PA, a claim may be denied or the patient may face the full cost, which can delay starting therapy.
Real-world evidence (RWE)
Real-world evidence (RWE) is information about patient health and care collected outside traditional clinical trials, such as insurance claims, electronic health records, registries, and program data. Analyzed as real-world evidence, it can show how therapies perform in everyday practice, support payer discussions, and reveal access barriers. Use of RWD must follow privacy rules and appropriate de-identification.
REMS (Risk Evaluation and Mitigation Strategy)
A Risk Evaluation and Mitigation Strategy (REMS) is a safety program the FDA can require for medications with serious risks, to help ensure benefits outweigh those risks. Elements can include prescriber certification, patient enrollment, and restricted dispensing. Hubs may help manage REMS enrollment, documentation, and reporting alongside access services.
Site of care
Site of care is the setting where a patient receives a treatment, such as a physician office, hospital outpatient department, infusion center, or the patient's home. Payers may set policies requiring patients to use specific sites, which can affect coverage, patient cost-sharing, and scheduling.
Specialty drug; biologic; biosimilar
A specialty drug is a high-cost medication, often for complex or chronic conditions, that may require special handling or monitoring. A biologic is a medicine made from living organisms, such as proteins or antibodies. A biosimilar is a biologic highly similar to an FDA-approved reference biologic, with no clinically meaningful differences in safety or effectiveness.
Specialty pharmacy; limited distribution drug (LDD)
A specialty pharmacy dispenses medications that are high-cost, complex, or require special handling, storage, or patient monitoring. A limited distribution drug (LDD) is available only through a restricted network of pharmacies chosen by the manufacturer. Specialty pharmacies often coordinate with hubs on enrollment, benefits, shipping, and patient follow-up.
Start form / enrollment form
A start form, also called an enrollment form, is the document or digital submission a prescriber's office completes to refer a patient to a manufacturer's hub program. It usually captures patient demographics, insurance information, the prescription, clinical details, and patient consent. A complete, accurate start form helps avoid delays in benefits verification and therapy initiation.
Time to therapy
Time to therapy is the interval between a prescription being written and the patient receiving a first dose. Treatment initiation is the point therapy begins. Manufacturers track time to therapy as a core measure of access program performance, since insurance steps such as benefits verification and prior authorization are common sources of delay.
Utilization management; step therapy; quantity limit
Utilization management (UM) refers to the controls health plans use to manage drug and service use, such as prior authorization, step therapy, and quantity limits. Step therapy requires trying preferred treatments first, and quantity limits cap the amount covered per fill or period. UM criteria differ by plan and are outlined in the plan's coverage policy.
Value analysis committee (VAC)
A value analysis committee (VAC) is a group within a hospital or health system that evaluates new products, such as devices and supplies, before approving their purchase and use. Members typically include clinicians, pharmacy, supply chain, and finance. Manufacturers prepare clinical and economic evidence to help the committee assess a product's value.
Value dossier (AMCP dossier)
A value dossier is a document presenting a product's clinical and economic evidence to payers and formulary decision makers. The AMCP dossier format is a widely used standard in the United States. A dossier typically includes product information, clinical data, comparative evidence, and economic models supporting coverage and reimbursement decisions.
White bagging; brown bagging+B35:G35
White bagging is when a specialty pharmacy, often required by the payer, dispenses a provider-administered drug and ships it to the clinic for a specific patient. Brown bagging is when the patient receives the drug from a pharmacy and brings it to the provider.
CPT code
CPT® (Current Procedural Terminology) codes are a standardized code set maintained by the American Medical Association that describes medical services and procedures performed by physicians and other healthcare professionals. Payers use CPT, which is Level I of HCPCS, to process claims. Diagnostics and procedures generally need an appropriate CPT code to be billed and paid.
eServices
PRO-spectus eServices is the technology layer supporting its patient access work, including electronic benefits verification, electronic prior authorization, and program management. It helps reduce manual steps so cases move faster and teams can track status, while PRO-spectus specialists remain involved where clinical judgment or payer follow-up is needed.
Hub data firewall
A hub data firewall is the set of policies and technical controls that separate patient-level information handled by a patient services program from a manufacturer's sales and marketing functions. It limits what data the manufacturer receives, often in de-identified or aggregate form, to protect patient privacy and keep support services independent from promotion.
Predictive analytics
Predictive analytics uses statistical models and machine learning on historical data to forecast outcomes. In patient access, it can flag patients at higher risk of delays, denials, or dropping off therapy so teams can intervene sooner. Predictions are probabilities rather than certainties, and results depend on data quality, privacy safeguards, and appropriate human review.
