The ability of an individual or a patient population to obtain or receive appropriate health care.
The term “clinical pathway” is not well known to most Americans. Yet, clinical pathways have been used for more than 30 years in hospitals and physician practices to make decisions about how to tailor a person’s medical treatment.
Also known by such terms as care maps, care paths, care protocols, and care modules, clinical pathways give detailed guidance to doctors on when and how to treat a patient’s disease at each stage of care – from diagnosis through surgery, drug therapy, and supportive care. This means pathways can influence the decisions doctors make about the timing of laboratory tests and scans, the sequence and use of specific medicines, and referral to other health professionals.
Typically, the aim of clinical pathways is to improve the coordination, consistency, and quality of care patients receive. Yet the purpose for an increasing number of pathways is changing. Increasingly, insurance companies are developing and using their own versions as a way to control their costs. This has led to concerns that insurer pathways may narrow patients’ treatment options and negatively affect quality of care or restrict access to emerging personalized therapies. Adding to this problem, most patients are not aware their care may be determined by a pathway and don’t know how to navigate in this new system of medical decision-making.
However, there are steps individuals can take if they are aware of clinical pathways and know how these programs work. This is the reason for this online resource, which “decodes” clinical pathways. As such, this module contains patient-friendly informational tools for patients, caregivers, and oncology practices and can serve as a resource for advocates to advance policy solutions.
What exactly is a clinical pathway? At its simplest, a pathway is a sequenced plan that translates published medical practice guidelines into the essential steps for treating a specific disease or condition based on evidence-based practice. A more formal definition from the Cochrane Collaboration, a global independent network of researchers and medical professionals, is that pathways are “structured multidisciplinary care plans used by health services to detail essential steps in the care of patients with a specific clinical problem.”
Translating these definitions into real-world terms, pathways are “roadmaps” that help guide doctors in managing the care of a patient at each state in the disease process. They also specify different treatment regimens, including the names of the drugs, dosing levels, and schedule for administration. However, pathways can differ significantly in their design and what they cover. Some are comprehensive and offer doctors and patients a range of treatment options, including access to clinical trials, while others narrow decision-making to a pre-determined checklist of tests and drug regimens and may not give physicians the flexibility to select treatments that are not “on” the pathway or financially incentivize physicians for treating on pathway.
Although clinical pathways are used to manage such challenging diseases as congestive heart failure and diabetes, most apply to cancer care and especially common cancers like breast, colon, prostate, lung, and certain blood cancers. Clinical pathways are also used to guide the care of difficult to treat cancers, such as pancreatic cancer.
Because clinical pathways guide decisions at every stage of cancer care, they exert a major influence over the treatments patients receive, which is why the purpose and design of pathways is so important. On the positive side, clinical pathways that are patient-focused allow oncologists and patients to weigh different treatment options, including enrolling in a clinical trial, based on such factors as the effectiveness, toxicity, convenience, and cost of specific therapies. Conversely, when pathways limit patients’ treatment options and make it difficult to use their best clinical judgment, they interfere with the practice of medicine and can affect patient outcomes.
Also of concern is the dramatic increase in the number of clinical pathways oncologists must follow when making treatment decisions for their patients. According to the American Society of Clinical Oncology (ASCO), some oncology practices must comply with eight or more different pathways. Because these pathways may vary significantly in what they cover, the reality is that competing pathways within the same practice can result in different treatment decisions for patients with the same type and stage of cancer with the possibility of different care experiences for financial reasons.
In light of these concerns, the cancer community is working to establish core standards for the design, implementation, and transparency of clinical pathways so all patients have access to the most beneficial and appropriate treatments for their disease. Of equal importance is educating the public about the widespread use of clinical pathways so patients can find out what treatment options are available to them.
While pathways translate treatment guidelines into structured care plans, clinical practice guidelines are published scientific documents that provide physicians with the “big picture” on the management of specific diseases. As such, clinical guidelines – or medical treatment guidelines – summarize and evaluate the latest clinical evidence on the prevention, diagnosis, management, and treatment options for a specific disease and present all possible decision options.
Clinical practice guidelines are developed by medical professional societies, physician organizations, and research institutions based on a rigorous peer-reviewed process and updated periodically. Well known examples of cancer treatment guidelines are published by the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN).
Despite being in use for decades, clinical pathways are not well understood – even among patient advocates and some health professionals. This led researchers to publish a scientific paper identifying the underlying characteristics of all pathways, regardless of their source.
Among the characteristics described in the paper is that a pathway:
Besides these “must-have” elements, both health professionals and researchers agree that clinical pathways should serve as recommendations to guide the decision-making of physicians and patients and not be “set in stone” determinations. This gives clinicians the option of not following a specific course of action if there is a valid reason for doing so, based on the needs of the patient.
At the same time, health professionals and patient advocates are pressing for transparency in how clinical pathways are developed, what they include, and the degree of flexibility physicians have to make treatment decisions that deviate from the pathway. As documented in a 2015 report from the health research firm Avelere, there is currently limited information about how clinical pathways are constructed and the evidence base used to develop them. This is unlike medical treatment guidelines, where the guidance document and supporting evidence are publicly available for all physicians, patients, health insurers, patient advocates, and others to use, review, and critique.
Unlike the medical treatment guidelines published by leading medical societies, physician organizations, and research institutions, clinical pathways are developed by a number of entities – hospitals, physician practices, and health insurance plans – which can affect how they are designed and what they cover.
According to Avelere, health professionals with specific expertise in the disease category are the leaders in developing clinical pathways and routinely work with health insurance companies and patient advocates to design and implement these care protocols. This makes sense because clinicians are the ones who use the pathways to determine the best treatment outcomes for each individual. Moreover, most provider-designed clinical pathways are produced at the local or institutional level, reflecting differences in the ways medicine is practiced in local communities.
However, there is a growing trend among insurance companies to develop their own care pathways as a way to govern how health services and treatments are covered through their health plans. Typically, these payer pathways attempt to standardize care across regions of the country and place greater emphasis on cost control than is typically found in pathways designed by hospitals and physician practices. This can mean less decision-making authority for doctors and fewer treatment options for patients.
When clinical pathways are designed to guide treatment decisions so each patient receives high quality care, they can improve patient outcomes, reduce unnecessary variations in patient care, drive value in the health system, and even help ensure that clinical trial options, if available, are always presented to patients.
The problems arise when pathways are restrictive, limit the clinical judgement of physicians, and attempt to standardize treatment options based on an “average” patient. This includes pathway programs developed by health plans that limit physician prescribing to a pre-determined “checklist” of drug regimens and either deny coverage or require prior authorization when the doctor opts for a different treatment based on the patient’s unique circumstances. In addition, restrictive pathways can delay needed care through a policy called “step therapy” or “fail first”, where patients are required to attempt treatment using a series of less expensive therapies and show they are ineffective before the insurance company will agree to pay for the medication prescribed by their doctor.
However, of greatest concern to health professionals and patient advocates are the number of pathways where health plans offer physicians pay-to-prescribe incentives linked to a narrow list of “on-pathway” therapies. For example, one large health plan pays doctors a $350 bonus payment per patient per month, as well as a $350 new patient fee, for selecting “on-pathway” treatments. Not only does this practice narrow patient choice but it erodes the doctor-patient relationship and the quality of medical care. Compounding the problem, the process by which insurers develop clinical pathways is not transparent – meaning patients may not know what treatments are covered on a pathway and whether their physician has a financial incentive to prescribe specific drugs.
Addressing these problems will require adopting policies that require insurance companies to disclose information about their clinical pathways. For this reason, the cancer community is pressing for transparency standards so patients will have the right to know the specifics of the pathway that governs their care. Among the information patients need to know are what tests and treatments are covered under the pathway, if their physician’s payments are based on following the pathway, how the pathway covers the costs of being on a clinical trial, and if physicians have flexibility to prescribe “off-pathway” treatments that meet patients’ unique needs.
Determining the best course of treatment is a daunting task for cancer patients and caregivers who rarely have the medical knowledge to evaluate the available options. Thus, patients place great trust in their care team in guiding them through the decision-making process and choosing a regimen that reflects that patient’s life circumstances and treatment goals.
For this reason, having a frank discussion about the role of clinical pathways is more important than ever before. For patients and caregivers, this means starting the conversation about treatment options by asking the oncologist if the regimen will be determined by a clinical pathway. If the answer is yes, the next step is to get as much information as possible about the specific pathway, including:
At the same time, the Affordable Care Act (ACA) now requires insurance companies to make available in concise, easy-to-understand language what their health plans cover. Although the main purpose is to make it easier for consumers to compare different plans, this information can also help cancer patients whose care is governed by a payer pathway.
Ways to get information on the drugs covered through the health plan are to:
Although cancer treatment can sound like a foreign language, it is possible to break the code. Here is a glossary of the most common medical terms associated with cancer care and specifically, clinical pathways.
The ability of an individual or a patient population to obtain or receive appropriate health care.
The initiation of care, usually referring to inpatient care.
Officially called the Patient Protection and Affordable Care Act, the ACA is a federal law enacted in 2010 that increases the quality, accessibility, and affordability of health insurance. Among its provisions, the ACA eliminates pre-existing conditions, prevents insurance companies from dropping people with costly medical conditions, expands preventative services and health benefits, requires larger employers to insure their employees, and creates an insurance marketplace to provide for subsidized insurance for lower income Americans.
Health services provided on an outpatient basis in contrast to services provided in the home or to persons admitted to a hospital for treated or treated in a long-term care facility.
Support service provided in conjunction with medical or hospital care. Such services include laboratory, radiology, physical therapy and inhalation therapy, among others.
A level of care set as a goal to be attained.
The health care items or services covered under a health insurance plan. Covered benefits and excluded services are defined in the health insurance plan's coverage documents.
A drug sold by a drug company under a specific name or trademark and that is protected by a patent.
The organization of a patient’s treatment across several health care providers.
A group comprising a variety of professionals (medical practitioners, nurses, pharmacists and other allied health professionals) who are involved in providing coordinated and comprehensive care to the patient.
Professional specialized or therapeutic care that requires ongoing assessment, planning, intervention and evaluation by health care professionals.
The process by which the physician or other health professional applies critical thinking to interpret the medical data about a specific patient, arrive at a diagnosis, and identify appropriate courses of treatment.
A sequenced, multidisciplinary plan that translates published medical practice guidelines into the essential steps for treating a specific disease or condition based on evidence-based practice. Clinical pathways give detailed guidance to doctors on when and how to treat a patient’s disease at each stage of care – from diagnosis through surgery, drug therapy, and supportive care – and are intended to maintain or improve quality of care for patients while controlling health costs. Also known as care maps, care paths, “care protocols and care modules.
A systematically developed statement that summarizes and evaluates the latest clinical evidence on the prevention, diagnosis, management and treatment options for a specific disease and present all possible decision options. Clinical practice guidelines are developed by medical professional societies, physician organizations and research institutions based on a rigorous peer-reviewed process and updated periodically.
The best available evidence gained from peer-reviewed scientific research to guide health decision-making.
An injury, ailment, disease, illness or disorder.
The relationship between the cost of an activity and the benefit that is achieves from it.
A set of steps to control the use of health services that contribute to higher than necessary costs.
A form of analysis that seeks to determine the costs and effectiveness of a health intervention compared with similar alternative interventions.
The share of costs covered by the health plan that the patient pays out of his or her own pocket.
The share of the costs of a covered health care service, calculated as a percentage (for example, 20%) of the allowed amount for the service. The patient pays coinsurance after meeting his or her deductible. For example, if the health insurance plan’s allowed amount for an office visit is $100 and the patient has met the deductible, the 20% coinsurance payment would be $20. The health insurance plan pays the rest.
A review that occurs during the course of patient treatment that enables the medical practitioner or other health care provider to evaluate whether the course of treatment is consistent with expectations for the usual management of a clinical case.
An integrated system of care that guides and tracks patients from diagnosis onward through a comprehensive array of health services spanning all levels and intensity of care.
A fixed amount (for example, $15) the patient pays for a covered health care service, usually when the service is provided (such as picking up a prescription). The amount can vary by the type of covered health care service.
An attribute or rule that serves as a basis for evaluation, definition or classification of something; an evaluation standard.
The amount the patient owes for covered health care services before the health insurance plan begins to pay. For example, if the deductible is $1,000, the plan won’t pay anything until the patient pays $1,000 for covered services.
Instruments, substances and techniques used to detect diseases and medical conditions.
Any activities by a health professional involving direct interaction, treatment, administration of medications or other therapy or involvement with a patient.
A list of prescription drugs covered by a prescription drug plan or another insurance plan offering prescription drug benefits. Also called a formulary.
The degree to which a treatment plan or intervention has achieved its purpose within the limits set for reaching its objective.
A process through which people acquire the knowledge and skills to gain greater control over decisions and actions affecting their health.
Those therapeutic agents considered indispensable for the rational care of a disease based on clinical evidence.
A process that attempts to determine, as systematically and objectively as possible, the relevance, effectiveness and impact of activities in the light of their objectives.
The conscientious, explicit and judicious use of current best evidence in making decisions about the care of individuals. This approach must balance the best external evidence with the desires of the individual and the clinical expertise of health care providers.
The application of the best available scientific evidence to decisions about specific treatments or care.
Health care services that the health insurance or plan doesn’t pay for or cover.
Most people must have qualifying health insurance or pay a fee. But people who qualify for a health coverage exemption don’t have to pay the fee. Exemptions are granted based on certain hardships and life events, health coverage or financial status, membership in some groups, and other circumstances.
A practice also called “step therapy” whereby health plans require patients to attempt treatment with one or a series of less expensive therapies and show they are ineffective before the insurance company will agree to pay for the medication prescribed by their doctor.
A method in which doctors and other health care providers are paid for each service performed. Examples of services include tests and office visits.
A listing of accepted fees or established allowances for specified medical or other professional procedures and services. As used in health plans, it usually represents the maximum amounts the plan will pay for the specified procedures.
A list of drugs, usually by their generic names, and indications for their use. A formulary is intended to include a sufficient range of medicines to enable medical practitioners to prescribe all medically appropriate treatment for all reasonably common illnesses. In some health plans, providers are limited to prescribing only drugs listed on the plan's formulary.
A health professional, who may be a medical practitioner, nurse or other professional, who has the first encounter with the patient and controls the individual's entry into the health care system.
An ultimate desired state of health towards which actions and resources are directed.
A change in a patient’s health status resulting from the delivery of health services and interventions.
Health care services a person receives at home.
Care in a hospital that usually doesn’t require an overnight stay.
Services to provide comfort and support for persons in the last stages of a terminal illness and their families.
The total, direct and indirect, effects of a treatment, intervention or program on health status.
A clinical symptom or circumstance indicating that the use of a particular treatment or intervention would be appropriate.
The percent (for example, 20%) the patient pays of the allowed amount for covered health care services to providers who contract with the health insurance or plan. In-network coinsurance usually costs less than out-of-network coinsurance.
An individual who has been admitted to a hospital or other facility for diagnosis and/or treatment that requires at least an overnight stay.
The health care patients receive when admitted as an inpatient to a hospital, nursing home or other facility.
A fixed amount (for example, $15) the patient pays for covered health care services to providers who contract with his or her health insurance or plan. In-network copayments usually are less than out-of-network copayments.
Health services delivered on an inpatient basis in hospitals, nursing homes or other inpatient institutions.
The methods and strategies for linking and coordinating the various aspects of care delivered by different practitioners and care systems to meet the multiple needs of the patient.
A treatment or service that is appropriate and consistent with a person's diagnosis and which, in accordance with locally accepted standards of practice, cannot be omitted without adversely affecting the person's condition or the quality of care.
The facilities, providers and suppliers the health insurer or plan has contracted with to provide health care services.
A measurable state of health that is expected to exist at a predetermined place and time as a result of the application specific interventions.
The results that may stem from a medical, surgical or therapeutic intervention or non-intervention.
The expenses for medical care that aren't reimbursed by insurance. Out-of-pocket costs include deductibles, coinsurance, and copayments for covered services plus all costs for services that aren't covered.
The total care offered to a person when it is recognized that the illness is no longer curable in order to concentrate on the person’s quality of life and the alleviation of distressing symptoms.
An approach to care that consciously adopts a patient’s perspective. This perspective can be characterized around dimensions such as respect for patients’ values, preferences and expressed needs; coordination and integration of care; information, communication and education; physical comfort, emotional support and alleviation of fear and anxiety; involvement of family and friends; or transition and continuity.
Companies and government agencies that finance or reimburse the cost of health services.
The process by which clinical practice guidelines and research papers are checked by a group of independent experts in the same field to make sure the information meets the necessary scientific standards before it is published.
A decision by the health insurer or plan that a health care service, treatment plan, prescription drug or durable medical equipment is medically necessary. Also called precertification.
Approval from a health plan that may be required before the patient gets a service or fills a prescription in order for the service or prescription to be covered by the plan.
Standards or practices developed to assist health care providers and patients to make and effect decisions about particular steps in the treatment process.
A hospital, facility, physician or other licensed healthcare professional that provides health care services to patients.
The degree to which delivered health services meet established professional standards and are judged to be of value to the patient.
A practice also called “fail first” whereby health plans require patients to attempt treatment with one or a series of less expensive therapies and show they are ineffective before the insurance company will agree to pay for the medication prescribed by their doctor.
An easy-to-read summary that lets consumers make apples-to-apples comparisons of costs and coverage between health plans.
A regulated course of treatment, including the use of specific medications, intended to cure or improve the outcomes of a patient with a disease or medical condition.
Use the following questions as a guide when talking to the oncology care team about clinical pathways and how they will govern the treatments you or your loved one receives. And remember: you are entitled to ask these questions and get the answers.