Definitions Of Health Care Terms

The following definitions may be helpful when reviewing the HMSA and CIGNA Medical Plans, the HDS and MetLife Dental Plans, and the Vision Service Plan (VSP). While every effort has been made to ensure these definitions reflect how the Plans are administered, each Plan will rely on the definitions provided in their respective plan documents when administering these benefits.

Note that these definitions are not intended to apply to the Kaiser HMO, which provides benefits based on the provisions outlined in its plan booklet.

Ambulatory Surgical Center (or Free-Standing Surgical Center)

A specialized facility established, equipped, operated, and staffed primarily for the purpose of performing surgical procedures and that fully meets one of the following two tests...

• It is licensed as an ambulatory surgical center by the regulatory authority having responsibility for the licensing under the laws of the jurisdiction in which it is located.

• Where licensing is not required, it:

  • is operated under the supervision of a licensed doctor of medicine (M.D.) or doctor of osteopathy (D.O.) who is devoted to full-time supervision and permits a surgical procedure to be performed only by a duly qualified physician who, at the time the procedure is performed, is privileged to perform the procedure in at least one hospital in the area;

  • requires in all cases, except those requiring only local infiltration anesthetics, that a licensed anesthesiologist administer the anesthetic, or supervise an anesthetist who is administering the anesthetic, and that the anesthesiologist or anesthetist remains present throughout the surgical procedure;

  • provides at least one operating room and at least one post-anesthesia recovery room;

  • is equipped to perform diagnostic X-ray and laboratory examinations, or has an arrangement to obtain these services;

  • has trained personnel and necessary equipment to handle emergency situations;

  • has immediate access to a blood bank or blood supplies;

  • provides the full-time service of one or more registered graduate nurses (RN) for patient care in the operating rooms and in the post-anesthesia recovery room; and

  • maintains an adequate medical record for each patient, containing an admitting diagnosis including (for all patients except those undergoing a procedure under local anesthesia) a preoperative examination report, medical history, lab tests and/or X-rays, an operative report, and a discharge summary.

An ambulatory surgical center that is part of a hospital will be considered an ambulatory surgical center for the purposes of this Plan as long as it meets this definition.

Birth Center

A specialized facility that is primarily a place for the delivery of children following a normal uncomplicated pregnancy and that fully meets one of the following two tests...

• It is licensed by the regulatory authority having responsibility for the licensing under the laws of the jurisdiction in which it is located.

• It:

  • is operated and equipped in accordance with any applicable state law;

  • is equipped to perform routine diagnostic and laboratory examinations such as hematocrit and urinalysis for glucose, protein, bacteria, and specific gravity;

  • has available to handle foreseeable emergencies, trained personnel and necessary equipment, including but not limited to oxygen, positive pressure mask, suction, intravenous equipment, equipment for maintaining infant temperature and ventilation, and blood expanders;

  • is operated under the full-time supervision of a licensed doctor of medicine (M.D.), doctor of osteopathy (D.O.) or registered graduate nurse (R.N.);

  • maintains a written agreement with at least one hospital in the area for immediate acceptance of patients who develop complications; and

  • maintains an adequate medical record for each patient, which includes prenatal history, prenatal examination, any lab or diagnostic tests, and a postpartum summary.

A birth center that is part of a hospital will be considered a birth center for the purposes of this Plan as long as it meets this definition.

Brand Name Drug

A brand name drug is a prescription drug that is a single source drug marketed under its distinctive trade name and which is, or was at one time, under patent protection. It must comply with the Food and Drug Administration's standards and be an innovator drug.

Calendar Year

A period beginning January 1 and ending December 31. This period is also known as the "Plan Year" for the purposes of all FlexSolutions health care plans. Note: When you enroll as a new hire, coverage in your initial year generally begins on your effective date of your coverage (as explained under When Coverage Begins), not the previous January 1.

Chemical Dependency

See substance abuse.

Claims Administrator

The entity responsible for administering claims. For the purposes of these health care plans, the claims administrators are HMSA, CIGNA, HDS, MetLife, and Vision Service Plan. Note: The Claims Administrator does not necessarily insure the benefits described in this Handbook.

Copayment

A copayment is the amount you must pay to a network provider at the time you receive certain services. The Plan then pays a certain percentage of the eligible expense (usually 100%). Any copayment amounts you pay generally do not count toward your deductible (if applicable).* For additional details, refer to the applicable health care plan descriptions provided elsewhere in this Handbook.

Covered Expense

Under the CIGNA Medical Plans, expenses incurred by or on behalf of a covered individual for charges listed under What The CIGNA Plans Cover. Expenses incurred for such charges are considered covered expenses to the extent that the services or supplies provided are recommended by a physician and are essential for the necessary care and treatment of an injury or a sickness.

Covered Family Members

(Also referred to as "covered dependents.") Any eligible dependents that are covered under this Plan, as defined under Who Is Eligible.

Deductible

The deductible is the amount you must pay before the Plan begins paying benefits. After you meet the deductible, the Plan pays a certain percentage of eligible expenses. For additional details, refer to the applicable health care plan descriptions provided elsewhere in this Handbook.

Eligible Charge

Under the HMSA Plans, the eligible charge is the amount upon which your copayment is based. The eligible charge is the lesser of either the...

• Provider's actual charge, or

• Amount HMSA establishes as the maximum allowable fee.

  Note that the eligible charge does not include excise tax or any other tax.

HMSA Participating Providers agree to accept the eligible charge for covered services, while non-participating providers generally do not. Therefore, if you receive services from a non-participating provider you are responsible for your regular copayment plus any difference between the actual charge and the eligible charge.

The following exceptions to eligible charges do apply...

• Discounted Arrangements—As a normal business practice (and as a means to keep your health plans affordable), HMSA may obtain discounts, rebates and other reductions in the cost of medical services and supplies from health care providers and suppliers. Any discounts or rebates received from these entities will not reduce the charge upon which your payments are based; however, such discounts or rebates will be used to reduce the subsequent rates of HMSA's plans.

• Prescription Drug Eligible Charges—The discounted arrangements described above may also apply to prescription drug charges. As such, any discounts or rebates HMSA receives from drug manufacturers or suppliers will not reduce the charges upon which your payments for prescription drugs are based; however, such discounts or rebates will be used to reduce the rates for all of HMSA's prescription drug plans.

  In determining the eligible charge for prescription drugs, HMSA will consider the eligible charge as the lesser of the actual charge or HMSA's allowable charge.*

  * The allowable charge is the cost of the drug to the provider (the Adjusted Average Wholesale Price) plus an allowance established by the Association for dispensing the drug (the dispensing fee).

• Claims for Services Provided by Out-of-State Providers— Benefit payments for covered services received outside Hawaii are based on whether the services are received from Blue Cross and/or Blue Shield Providers or other providers. Benefits received from:

  • Blue Cross and/or Blue Shield Providers are based on the contract negotiated between the out-of-area Blue Cross and/or Blue Shield plans and their participating providers. Such contracts have copayments based on negotiated discounted charges or the provider's actual charges. The amount you pay for covered services will be lower when the contracted amount is based on discounted charges rather than the provider's actual charges.

  • Other Providers (providers who are not Blue Cross and/or Blue Shield participating providers) are based on the eligible charges for the same or comparable services received from non-participating providers in Hawaii.

Eligible Employee

An employee eligible for benefits under this Plan as defined under Who Is Eligible.

Emergency Services

The medical, psychiatric, surgical, hospital and related health care services, including testing and ambulance service, provided after the sudden onset of a medical condition that results in acute symptoms, (including severe pain), severe enough that the lack of immediate medical attention could reasonably be expected to...

• Place the individual's health in serious jeopardy,

• Seriously impair bodily function, or

• Result in serious or permanent dysfunction of a bodily organ or part.

Under the CIGNA Plans, this includes any immediate treatment for alcoholism, drug abuse, or any mental or nervous disorders in which the lack of treatment could reasonably be expected to result in self injury or injury to other individuals.

Experimental or Investigational Services

Under the HMSA Medical Plans: A medical treatment, procedure, drug, device, or care is experimental or investigative if:

• The drug or device cannot be lawfully marketed without approval of the U.S. Food and Drug Administration and approval for marketing has not been given at the time the drug or device is furnished.

• The drug, device, medical treatment, or procedure, or the patient informed consent document utilized with the drug, device, treatment, or procedure was reviewed and approved by the treating facility's Institutional Review Board or other body serving a similar function, or if federal law requires such review and approval.

• Reliable evidence shows that the drug, device, medical treatment, or procedure is the subject of ongoing Phase I or Phase II clinical trials; is for the research, experimental study, or investigational arm of ongoing Phase III clinical trials; or is otherwise under study to determine its maximum tolerated dose, its toxicity, its safety, its efficacy or its efficacy compared with a standard means of treatment or diagnosis.

• Reliable evidence shows that the prevailing opinion among experts regarding the drug, device, medical treatment, or procedure is that further studies or clinical trials are necessary to determine its maximum tolerated dose, toxicity, safety, efficacy, or its efficacy compared with a standard means of treatment or diagnosis.

For the purposes of this provision, "Reliable Evidence" shall mean only:

• Published reports and articles in authoritative medical and scientific literature.

• The written protocol or protocols used by the treating facility or the protocol(s) of another facility studying substantially the same drug, device, medical treatment or procedure.

• The written informed consent used by the treating facility or by another facility studying substantially the same drug, device, medical treatment, or procedure.

Generic Drug

A prescription drug that is available from multiple sources and is no longer under patent protection. It must comply with the Food and Drug Administration's standards. In addition, under the HMSA Plans a drug that is prescribed or dispensed under its commonly used generic (chemical) name and that is no longer protected under patent law or as determined by HMSA to be a generic drug.

Health Care Provider

A licensed or certified provider other than a physician whose services might be considered eligible under this Plan. Usually such services are eligible due to a state law requiring payment of services provided within the scope of that provider's license or certification.

Home Health Care Agency

Under the HMSA Medical Plans: An agency or organization that provides a program of home health care and meets one of the following three tests: It...

• Is approved by Medicare,

• Is established and operated in accordance with the applicable licensing and other laws, and

• Meets all of the following requirements:

  • has the primary purpose of providing home health care,

  • has a delivery system for bringing supportive services to the home,

  • has a full-time administrator,

  • maintains written records of services provided to the patient,

  • its staff includes at least one registered graduate nurse (R.N.), or it has nursing care by a registered graduate nurse (R.N.) available,

  • its employees are bonded, and

  • it maintains malpractice insurance.

Under the CIGNA Medical Plans: A hospital or a non-profit or public agency that...

• Primarily provides skilled nursing services and other therapeutic services under the supervision of a physician or nurse,

• Is operated according to rules established by a group of professional persons,

• Maintains clinical records on all patients, and

• Does not primarily provide custodial care or care and treatment of the mentally ill.

Hospice Care Program

Under the CIGNA Medical Plans: A hospice care program means...

• A coordinated, interdisciplinary program to meet the physical, psychological, spiritual, and social needs of a terminally ill person and his or her family.

• A program that provides palliative and supportive medical, nursing, and other health services through home or inpatient care during the illness.

A terminally ill person is someone who is expected to live less than six months.

Hospice Facility

Under the HMSA Medical Plans: An agency that provides counseling and incidental medical services to a terminally ill individual. Such services may include room and board. To be eligible, the agency must...

• Be approved by Medicare as a hospice (and, under the HMSA Plans, be under contract with HMSA as a hospice facility),

• Be licensed in accordance with any applicable state laws, and

• Meet the following requirements:

  • provide services 24 hours a day, seven days a week,

  • be under the direct supervision of a duly qualified physician,

  • have a nurse coordinator who is a registered graduated nurse with four years of full-time clinical experience (including two years involving the care for terminally ill patients),

  • have as its main purpose the providing of hospice services,

  • have a full-time administrator,

  • maintain written records of services given to the patient, and

  • maintain malpractice insurance coverage.

A hospice that is part of a hospital will be considered a hospice for the purposes of this Plan as long as it meets this definition.

Under the CIGNA Medical Plans: An institution or part of an institution which...

• Primarily provides care for terminally ill patients,

• Is accredited by the National Hospice Organization,

• Meets the standards established by CIGNA, and

• Fulfills any licensing requirements of the state of locality in which it operates.

Hospital

An acute care institution that is engaged primarily in providing facilities for surgery, diagnosis, and treatment of ill and injured persons on an inpatient basis at the patient's expense. Under the...

• HMSA Plans, the hospital must be...

  • licensed as a hospital by the proper government authority, and

  • approved by Medicare as a hospital.

• CIGNA Plans, the hospital must be...

  • accredited as a hospital by the Joint Commission on Accreditation of Healthcare Organizations, and

  • certified as a hospital by the proper government authority.

In addition, under all of the Plans, the hospital must...

• Maintain on the premises, diagnostic and therapeutic facilities for the surgical and medical diagnosis and treatment of sick and injured individuals by or under the supervision of a staff of duly qualified physicians,

• Continuously provide on the premises 24-hour-a-day nursing service by or under the supervision of registered nurses, and

• Operate continuously with organized facilities for operative surgery on the premises.

Illness

See Sickness.

Mail Order Pharmacy

A pharmacy that has agreed to participate in the HMSA or CIGNA mail order program.

Medicare

The Health Insurance For The Aged and Disabled program under Title XVIII of the Social Security Act of 1965. (See Effect Of Medicare for details on how this Plan coordinates with Medicare.)

Medicare-Eligible Individual

Any individual eligible to enroll in, and be covered by, the voluntary portion of Medicare.

Mental (or Nervous)/Substance Abuse Disorder Treatment

Includes treatment for any sickness...

• Identified in the current edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM) of the American Psychiatric Association, including a psychological and/or physiological dependence or addiction to alcohol or psychoactive drugs or medications, regardless of any underlying physical or organic cause.

• Where the treatment is primarily the use of psychotherapy or other psychotherapeutic methods.

• For which treatment is provided by a psychiatrist or psychologist only.

• Under the HMSA Plans only, by a clinical social worker or advanced practice registered nurse.

All inpatient services (including room and board,) provided for an illness identified in the DSM and provided by a mental health facility or area of a hospital providing mental health or substance abuse treatment are considered mental disorder treatment, except in the case of multiple diagnoses. (If there are multiple diagnoses, only the treatment for the illness identified in the DSM is considered mental disorder treatment.)

Detoxification services given before, and independent of, a course of psychotherapy or substance abuse treatment is not considered mental disorder treatment.

Prescription drugs are not considered part of mental disorder treatment; however, they may be covered under the prescription drug program.

Network Provider (or Participating Provider)

A hospital, pharmacy, physician, dentist, or other health care provider that participates in the various FlexSolutions health care plan networks (i.e., the HMSA PPO and Health Plan Hawaii Plus networks; the CIGNA PPO and HMO networks; the HDS and MetLife Dental Plan networks; and the Vision Service Plan network). This may include a hospital, physician, dentist, or registered and licensed pharmacies, including mail order pharmacies, as defined in this section. Network providers agree to accept not more than a specified amount as determined by the Claims Administrator in accordance with the applicable fee schedule.

Note that under the HMSA Plans, network providers are a subset of HMSA's participating provider group.

No-Fault Automobile Insurance Law

A law providing for payments without determining fault in connection with automobile accidents.

Non-Network Provider (Non-Participating Provider)

A hospital, pharmacy, physician, dentist, or other health care provider that does not participate in any of the networks referenced under the definition of Network Provider above. Note that the various health care plan Claims Administrators have no contract with such providers to guarantee you that the provider's charges will not exceed reasonable charges; any amount charged by a non-network provider is owed by you, regardless of the amount of reimbursement you receive from the Plan.

Non-Participating Provider

Under the HMSA Medical Plans: A health care provider that does not participate in the HMSA provider system. Note that HMSA has no contract with such providers to guarantee you that the provider's charges will not exceed eligible charges. Any amount charged by a non-participating provider in excess of the total charge is owed by you, regardless of the amount of reimbursement you receive from HMSA.

Nurse

A registered graduate nurse, a licensed practical nurse or a licensed vocational nurse who has the right to use the abbreviation "R.N.," "L.P.N.," or "L.V.N."

Nurse-Midwife

An individual who is licensed or certified to practice as a nurse-midwife and fulfills these requirements...

• Is licensed by a board of nursing as a registered nurse

• Has completed a program approved by the state for the preparation of nurse-midwives

• Is certified by the American College of Nurse-Midwives

• Is formally associated with a physician for the purposes of supervision and consultation.

Nurse-Practitioner

An individual who is licensed or certified to practice as a nurse-practitioner and fulfills both of these requirements...

• Is licensed by a board of nursing as a registered nurse, and

• Has completed a program approved by the state for the preparation of nurse-practitioners.

Optometrist

An individual licensed to practice optometry.

Other Services and Supplies

Services and supplies furnished to the individual and required for treatment, other than the professional services of any physician and any private duty or special nursing services (including intensive nursing care, regardless of its name).

Payment Determination Criteria

Under the HMSA Plans: To be considered eligible for coverage, the services and supplies provided must be...

• Appropriate and necessary for the symptoms, diagnosis and direct care of the individual's illness or injury; for the purposes of this provision, an illness or injury is any bodily disorder, bodily injury, disease, or condition, including pregnancy and complications of pregnancy;

• Consistent with professionally recognized standards of health care in the United States, and given at the right time and in the right setting;

• Not primarily for the individual's convenience, or the convenience of the individual's provider; and

• The most appropriate supply or level of service that can safely be provided.

The Plan will not cover any service or supply (or portion of any service or supply) that does not meet these payment determination criteria. The fact that a physician or other provider may prescribe, order, recommend, or approve a service or supply does not in itself mean that the service or supply is a covered service. More than one procedure, service or supply may be appropriate for the diagnosis and treatment of the individual's condition, in which case the Plan reserves the right to approve only the least costly treatment, service or supply.

Physician

For most of the health care plans, a physician is a legally qualified Doctor of Medicine (M.D.), Doctor of Osteopathy (D.O.), Doctor of Podiatry (D.P.M.), Doctor of Chiropody (D.P.M.; D.S.C.), Doctor of Chiropractic (D.C.),* Doctor of Dental Surgery (D.D.S.), or Doctor of Medical Dentistry (D.M.D.).

Under the CIGNA Plans, a physician is a licensed medical practitioner who is practicing within the scope of his license and is licensed to prescribe and administer drugs or to perform surgery.

Physician Standby Services

Services performed by a physician in attendance for a treatment or procedure where the physician does not provide direct care to the patient.

Plan Year

January 1 through December 31. See also the definition of "Calendar Year."

Precertification

Under the HMSA Medical Plans: A process of review and approval that must be completed before certain medical services are eligible for benefits. (See Precertification for details.)

Prescription Drugs

The following items are considered prescription drugs for the purposes of the prescription drug benefits provided under the FlexSolutions Medical Plans...

• Federal Legend Drugs (excluding vitamins)—this is any medicinal substance that the FDA requires to be labeled "Caution— Federal law prohibits dispensing without prescription"

• Drugs that require a prescription under state law but not under federal law

• Compound drugs—a drug with more than one ingredient, at least one of which must be a Federal Legend Drug or a drug that requires prescription under state law

• Injectable insulin and certain diabetic supplies (i.e. lancets and diabetic test strips)

• Oral contraceptives

• Chem and glucose sticks

• Needles and syringes

Note that a prescription drug refers to medication that by federal law can only be dispensed upon a physician's prescription.

Primary Care Physician (PCP)

A physician in general practice or one who specializes in pediatrics, family practice or internal medicine, or any licensed physician who has agreed with the Claims Administrator to coordinate a covered individual's care. The PCP is not an agent or employee of the Claims Administrator. Individuals enrolled in the HMSA Health Plan Hawaii Plus Plan or the CIGNA Network HMO Plan, must designate a PCP.

Provider

A health care practitioner who...

• Qualifies as such under the requirements of the Federal Medicare Program

• Is certified or licensed by the proper government authority, and

• Renders services within the lawful scope of his or her respective license.

Psychiatric/Chemical Dependency Disorder, Treatment of

See Mental (or Nervous)/Substance Abuse Disorder Treatment

Reasonable and Customary (MetLife Dental Plan)

For the purposes of the MetLife-administered Dental Plan, the "reasonable and customary" (R&C) charge is defined as the lowest of the:

• Usual charge made by the dentist or other provider of the services or supplies for the same or similar services or supplies,

• Usual charge of most other Dentists or other providers in the same geographic area for the same or similar services or supplies, or

• Actual charge for the services or supplies.

Reasonable and Customary Charge (CIGNA Medical Plans)

Under the CIGNA Medical Plans, a charge will be considered "reasonable and customary" if:

• It is the normal charge made by the provider for a similar service or supply, and

• It does not exceed the normal charge made by most providers of such service or supply in the geographic area where the service was received.

To determine if a charge is reasonable and customary, the nature and severity of the injury or sickness being treated will be considered.

Rehabilitation Facility

A facility accredited as a rehabilitation facility by the Commission on Accreditation of Rehabilitation Facilities. Includes skilled nursing facilities, rehabilitation hospitals, and sub-acute facilities.

Room and Board

Room, board, general duty nursing, intensive nursing care (regardless of name), and any other services regularly furnished by the hospital as a condition of occupancy for the class of accommodations occupied. This does not include professional services of physicians nor special nursing services rendered outside an intensive care unit (regardless of name).

Sickness

Any physical or mental illness, including pregnancy. Also, in connection with newborn children, congenital birth defects and birth abnormalities (including premature births).

Skilled Nursing Facility

Under the HMSA Medical Plans: A facility to which an individual is admitted (by a physician) for skilled nursing services (but not custodial care) provided under the care of an attending physician. To be eligible for benefits, the facility must meet Medicare standards, or it must...

• Operate under the applicable licensing and other laws;

• Be under the supervision of a licensed physician or registered nurse (R.N.) devoted to full-time supervision;

• Regularly engage in providing room and board, continuously providing, 24 hours a day, skilled nursing care of sick and injured individuals at the patient's expense during the convalescent stage of an injury or illness; and

• Be authorized to administer medication to patients on the order of a duly licensed physician.

The facility must also maintain a daily medical record of each patient who is under the care of a duly licensed physician and not be (other than incidentally) a home for the aged; the blind or the deaf; a hotel; a domiciliary care home; a maternity home; or a home for alcoholics, drug addicts or the mentally ill.

A skilled nursing facility that is part of a hospital will be considered a skilled nursing facility for the purposes of this Plan as long as it meets this definition.

Under the HMSA Plans, the facility must be approved by HMSA

Under the CIGNA Medical Plans: A licensed institution (other than a hospital) that specializes in physical rehabilitation, skilled nursing and/or medical care, but only if the institution:

• Maintains all facilities necessary for medical treatment on the premises,

• Provides treatment on an inpatient basis at the patient's expense under the supervision of physicians, and

• Provides nursing services.

Social Worker

A person who specializes in clinical social work and is licensed or certified as a social worker by the appropriate authority.

Substance Abuse

A condition of psychological and/or physiological dependence or addiction to alcohol or psychoactive drugs or medications that results in functional (physical, cognitive, mental, affective, social, or behavioral) impairment.

Total Disability (as it applies to health coverage)

In the case of a covered employee, the inability to perform all of the substantial and material duties of the individual's regular employment or occupation. In the case of a covered dependent, the inability to perform the normal activities of an individual of like age and gender. Note that this definition applies to health care coverage; the definition of total disability as it pertains to A&B's Long-Term Disability (LTD) Plan may differ.

Treatment Center

A facility that provides a program of effective medical and therapeutic treatment for mental/nervous and substance abuse disorders. The center must...

• Be established and operated in accordance with any applicable state law;

• Provide a program of treatment approved by the physician and the Plan;

• Have or maintain a written, specific and detailed regimen requiring full-time residence and full-time participation by the patient; and

• Provide at least the following basic services:

  • room and board (if the Plan provides inpatient benefits at a treatment center),

  • evaluation and diagnosis,

  • counseling, and

  • referral and orientation to specialized community resources.

Treatment centers that qualify as a hospital (as defined by this Plan) are covered as a hospital and not as a treatment center.

Urgent Care

Under the CIGNA Medical Plans: Medical, surgical, hospital or related health care services and testing which are not emergency services, but which are (as determined by CIGNA in accordance with generally accepted medical standards) necessary to treat a condition requiring prompt medical attention.

Usual, Customary and Reasonable (HDS Dental Plan)

For the purposes of the HDS-administered Dental Plans, UCR is defined as follows:

• Usual—a fee regularly charged and received by an individual dentist for a given service; i.e., his or her own usual fee. If more than one fee is charged for a given service, the fee determined to be usual shall not exceed the lowest fee regularly charged or offered to patients.

• Customary—a fee within the range of usual fees charged and received by dentists of similar training for the same service within a given geographic area.

• Reasonable—a fee that is "usual and customary" or above "usual and customary" but considered justifiable because of special circumstances or extraordinary difficulties.