Note: See page 112 for our payment levels for medications to promote better health as recommended under the Affordable Care Act. Benefits are not available for inpatient SNF care solely for management of tube feedings, for home level dialysis treatment, as an interim transition to long-term care placement, or for any other noncovered services. See page 119 in Section 5(f) for more information. You must also pay any charges for noncovered services. Precertification is required for all of the following services and must be provided by a covered facility or covered provider as defined in Section 3. Drugs determined to be of equal therapeutic value and similar safety and efficacy are then evaluated on the basis of cost. You must cooperate in doing what is reasonably necessary to assist us, and you must not take any action that may prejudice these rights of recovery. However, our failure to provide you with new evidence or rationale in sufficient time to allow you to timely respond shall not invalidate our decision on reconsideration. Your cost-share for care performed and billed by Preferred professional providers in the outpatient department of a Preferred hospital is waived for services other than surgical services, drugs, supplies, orthopedic and prosthetic devices, and durable medical equipment. Section 5. OPM negotiates benefits and rates with each plan annually. You do not need precertification of a maternity admission for a routine delivery. Room and board, such as semiprivate room, nursing care, meals, special diets, ancillary charges, and covered therapy services when billed by the facility (see page 39 for services billed by professional providers). When we are the secondary payor, we will determine our allowance. FOR SUBSCRIBERS. Benefits and rates under the replacement coverage will differ from benefits and rates under the FEHB Program. You are also responsible for the copayments for refills ordered by your physician. Foster childrenCoverage: Foster children are eligible for coverage until their 26th birthday if you provide documentation of your regular and substantial support of the child and sign a certification stating that your foster child meets all the requirements. Important things you should keep in mind about these benefits: Outpatient professional servicesof physicians and other healthcare professionals: Note: Please refer to pages 40-42 for our coverage of laboratory, X-ray, and other diagnostic tests billed for by a healthcare professional, and to page 83 for our coverage of these services when billed for by a facility, such as the outpatient department of a hospital. Preferred facilities: $175 (no deductible) per admission, Member facilities: $275 plus 35% of the Plan allowance (no deductible) per admission, Non-member facilities: $275 plus 35% of the Plan allowance (no deductible), and any remaining balance after our payment, per admission. They most likely clip to thin eyeglass frames and may or may not be very durable. These benefits will be paid if the hospice care program begins after a persons primary doctor certifies terminal illness and life expectancy of six months or less and any services or inpatient hospice stay that is part of the program is: Remission is the halt or actual reduction in the progression of illness resulting in discharge from a hospice care program with no further expenses incurred. The condition of an individual who is unable to conceive or produce conception during a period of one year. ), We now provide 8 visits per calendar year to treat depression associated with pregnancy with no member cost-share when a Preferred provider is used. Covered therapy services when billed by the facility (see Section, Provided while the person is covered by this Plan, Provided within six months from the date the person entered or re-entered (after a period of remission) a hospice care program, Non-surgical physician services and supplies, Treatment outside a hospital or in the outpatient/emergency room department of a hospital or urgent care facility. Note: When unusual circumstances require the removal of casts or sutures by a physician other than the one who applied them, the Local Plan may determine that a separate allowance is payable. Note: See Section 5(b) for our coverage for surgical procedures. You may get information about us, our networks, and our providers. A Carriers pursuit of a recovery if a covered individual has suffered an illness or injury and has received, in connection with that illness or injury, a payment from any party that may be liable, any applicable insurance policy, or a workers compensation program or insurance policy, and the terms of the Carriers health benefits plan require the covered individual, as a result of such payment, to reimburse the Carrier out of the payment to the extent of the benefits initially paid or provided. Annuitants coverage and premiums begin on January 1. Retail - When using a retail pharmacy for eligible Medicare Part B medication or supplies, present the Medicare ID card. OPM has determined that the Government Employees Health Association, Inc. prescription drug coverage is, on average, expected to pay out as much as the standard Medicare prescription drug coverage will pay for all plan secondary and tertiary claim payment is the lesser of: If a participating pharmacy is not available where you reside or you do not use your identification card, you must submit your claim to: Contraceptive drugs and devices as listed in the. Member/Non-member facilities: You pay all charges. Injectable, infused, inhaled, or oral therapeutic agents, or products of biotechnology, Complex drug therapy for a chronic or complex condition, and/or high potential for drug adverse effects, Specialized patient training on the administration of the drug (including supplies and devices needed for administration) and coordination of care is required prior to drug therapy initiation and/or during therapy, Unique patient compliance and safety monitoring requirements, Unique requirements for handling, shipping, and storage. You must cooperate with the review process. Benefits described in this brochure are available to all members meeting medical necessity guidelines regardless of race, color, national origin, age, disability, religion, sex or gender. There are important features you should be aware of. GEHA has a strong patient safety program. You may remain in the hospital up to 48 hours after a regular delivery and 96 hours after a cesarean delivery. Discount Drug Program The Discount Drug Program is available to members at no additional premium cost. A clinical trial has possible benefits as well as risks. An HRA does not affect your ability to participate in an FSAFEDS Healthcare Flexible Spending Account (HCFSA). If included with the surgeons bill, surgery benefits will apply.Note: If you need a mastectomy, you may choose to have the procedure performed on an inpatient basis and remain in the hospital up to 48 hours after the procedure. Dental care. If you are covered under our Plan as a dependent, any group health insurance you have from your employer will pay primary and we will pay secondary. If the amount your provider bills for covered services is less than our allowance, we base your share (coinsurance, deductible, and/or copayments), on the billed amount. This includes: Note: We provide benefits for services billed by Participating/ Non-participating providers related to Influenza (flu) vaccines. Here are some examples: Fraud increases the cost of healthcare for everyone and increases your Federal Employees Health Benefits Program premium. See Section 4. The Original Medicare Plan pays its share and you pay your share. Surgery to correct congenital anomalies for individuals age 18 and older unless there is a functional deficit. A compound medication includes more than one ingredient andis custom made by a pharmacist according to your doctor's instructions. Ray-Ban. We offer everything from a homeowner that wants a great piece of equipment right up to the big guys producing thousands of cords of wood a year. Call us or visit our website if you have any questions about dispensing limits. Protect Yourself From Fraud Here are some things that you can do to prevent fraud: CALL - THE HEALTHCARE FRAUD HOTLINE877-499-7295OR go to www.opm.gov/our-inspector-general/hotline-to-report-fraud-waste-or-abuse/complaint-formThe online reporting form is the desired method of reporting fraud in order to ensure accuracy, and a quicker response time. It is the way everyone used to get Medicare benefits and is the way most people get their Medicare Part A and Part B benefits now. We cover outpatient care related to other types of dental procedures only when a non-dental physical impairment exists that makes the hospital setting necessary to safeguard the health of the patient. The Plan extends coverage for the diagnoses as indicated below. To order your free glucose meter kit, call us toll-free at 855-582-2024, Monday through Friday, from 9 a.m. to 7 p.m., Eastern Time, or visit our website at www.fepblue.org. The Original Medicare Plan (Original Medicare) is available everywhere in the United States. For our coverage of hospital-based clinic visits, please refer to the professional benefits described on pages 39-40 and page 55 for vision services. WebYou can also get exclusive discounts on many health care items through CVS Pharmacy online, A dental emergency kit used for the temporary repair of loose caps or lost fillings is an eligible medical expense. You are protected by an annual catastrophic maximum on out-of-pocket expenses for covered services. You can request reimbursement in any amount. Contains screwdriver, 2 metric and American Std. You can also improve the quality and safety of your own healthcare and that of your family members by learning more about and understanding your risks. If you have a Self Only enrollment in a fee-for-service plan or in an HMO that serves the area where your children live, your employing office will change your enrollment to Self Plus One or Self and Family, as appropriate, in the same option of the same plan; or. Healthcare coverage that you are eligible for based on your employment, or your membership in or connection with a particular organization or group, that provides payment for medical services or supplies, or that pays a specific amount of more than $200 per day for hospitalization (including extension of any of these benefits through COBRA). Sale!About Us. It is important to assure services are authorized and provided by a covered provider or facility. You must include all benefits paid by GEHA in any claim for compensation you or your representative assert against any tortfeasor, insurer, or other party for the injury or illness, and assign all proceeds recovered from any party, including your own and/or other insurance, to GEHA for up to the amount of the benefits paid. A generic equivalent will be dispensed unless you or your physician specifies that the prescription be dispensed as written, when an FDA approved generic drug is available unless substitution is prohibitedby state law. All services must be provided on its premises, under its control, or through a written agreement with a hospital or with a specialized provider of those facilities. See page 20 for the exceptions to this requirement. We do not waive deductibles or coinsurance for Medicare members enrolled in the High Deductible Health Plan. Members with primary Medicare Part B coverage may purchase a supply of more than 21 days up to 90 days through the Mail Service Prescription Drug Program for a single copayment. An examination or test of an individual with no signs or symptoms of the specific disease for which the examination or test is being done, to identify the potential for that disease and prevent its occurrence. For more information about the source of the data we are currently using you may call us at 800-821-6136. Contact your employing or retirement office if you are changing from Selfto Self Plus One or Self and Family or to add a family member if you currently have a Self Only plan. You can also contact us to request that we mail you a copy of that Notice. 4.4 out of 5 stars 89. Those who have a checking or savings account, but also use financial alternatives like check cashing services are considered underbanked. These drugs are used in the treatment of complex, chronic medical conditions which include but are not limited to hemophilia, multiple sclerosis, hepatitis, cancer, rheumatoid arthritis, pulmonary hypertension, transplant, HIV, osteoarthritis, and immune deficiency. There is no cost to the member when the designated pump is obtained through a contracted provider. Note: You pay a $5 copayment for each purchase of up to a 30-day supply ($15 copayment for a 31 to 90-day supply) when Medicare Part B is primary. Ineligible. Your own HSA contributions are either tax-deductible or pre-tax (if made by payroll deduction). For instance, you means the enrollee and each covered family member; we means the Blue Cross and Blue Shield Service Benefit Plan. Note: See Section 5(b) for our benefits for oral and maxillofacial surgery, and Section 5(c) for our benefits for hospital services (inpatient/outpatient) in connection with dental services, available under both Standard Option and Basic Option. Note: Here are some things to keep in mind: Note: See page 156 for our payment for inpatient stays resulting from an emergency delivery at a hospital or other facility not contracted with your Local Plan. A range of voluntary family planningservices, limited to: Note: We cover other contraceptives under the Prescription drug benefits in Section 5(f). For a Self Plus One or a Self and Family enrollment, your out-of-pocket maximum for these types of expenses is $13,000 when you use Preferred providers. You must raise eligibility issues with your agency personnel/payroll office if you are an employee, your retirement system if you are an annuitant, or the Office of Workers Compensation Programs if you are receiving Workers Compensation benefits. Here are some examples: Fraud increases the cost of healthcare for everyone and increases your Federal Employees Health Benefits Program premium. You should also see Important Notice About Surprise Billing Know Your Rights in Section 4 that describes your protections against surprise billing under the No Surprises Act. See pages 81-82 for the benefits we provide. Note: See page 77 for our coverage of acupuncture when provided as anesthesia for covered surgery. Note: Voice training specific to gender affirmation is covered under speech therapy benefits. When the Original Medicare Plan is the primary payor, Medicare processes your claim first. Each Local Plan contracts with hospitals and other healthcare facilities, physicians, and other healthcare professionals in its service area, and is responsible for processing and paying claims for services you receive within that area. There is a PPO deductible and a non-PPO deductible for the entire Plan year for covered services - medical, prescription, inpatient, outpatient, mental health and manipulative therapy- you must incur for almost all covered services and supplies before we start paying benefits. Note: For Preferred facility care related to maternity, including care at Preferred birthing facilities, your responsibility for covered inpatient services is limited to $250 per admission. Refer to Section 4, Your catastrophic protection out-of-pocket maximum, and Section 5, Traditional medical coverage subject to the deductible, for more details. For example, if your physician ordinarily charges $100 for a service but routinely waives your 25% coinsurance, the actual charge is $75. Customer service may be reached at 800-821-6136 or through our website: Government Employees Health Association, Inc. OPM negotiates benefits and rates with each plan annually. Note: We pay inpatient benefits if you are admitted as a result of a medical emergency. If you use a non-PPO provider the annual maximum for out-of-pocket expenses is $7,000 for Self Only or $14,000for Self Plus One (not to exceed $7,000 per person) and $14,000when enrollment is Self and Family (any combination of family members, not to exceed $7,000 per person). Although some of these complications may not be avoidable,patients do suffer from injuries or illnesses that could have been prevented if doctors or the hospital had taken proper precautions. You are responsible for your deductible (Standard Option only), coinsurance, or copayments under this Plan. Also includes infertility associated with medical andsurgical gender reassignment. We provide benefits at Preferred benefit levels for emergency room services performed by both PPO and non-PPO providers when their services are related to an accidental injury or medical emergency. For more information on patient safety, please visit: When you enter the hospital for treatment of one medical problem, you do notexpect to leave with additional injuries, infections or other serious conditions that occur during the course of your stay. You must tell us if you or a covered family member has coverage under any other group health plan or has automobile insurance that pays healthcare expenses without regard to fault. One double channel electric breast pump with double suction capability is purchased for breast-feeding patients with a physicians prescription every two years. Note: Benefits for acupuncture are limited to 12 visits per calendar year. Providers must perform covered services acting within the scope of their license or certification under applicable state law. Save copies of all medical bills, including those you accumulate to satisfy a deductible. 360ee (b) (3)) is a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. In general, to be considered a medical food, a product must, at a minimum, meet the following criteria: the product must be a food for oral or tube feeding; the product must be labeled for the dietary management of a specific medical disorder, disease, or condition for which there are distinctive nutritional requirements; and the product must be intended to be used under medical supervision. Recreational or educational therapy, and any related diagnostic testing, except as provided by a hospital during a covered inpatient stay. Services, drugs, or supplies ordered orfurnished by a non-covered provider. You should be aware that some Non-preferred (non-PPO) professional providers may provide services in Preferred (PPO) facilities. We may provide our decision orally within these time frames, but we will follow up with written or electronic notification within three days of oral notification. You can use funds in your HRA to help pay your health plan deductible and/or for certain expenses that dont count toward the deductible. You may be responsible for any difference between our payment and the billed amount. Note: Avoid paying providers for services prior to preauthorization. If the transplant recipient is age 21 or younger, we pay up to $10,000 for eligible travel costs for the member and companions. See Section 5(a), Biliopancreatic bypass with duodenal switch. Benefits described in this brochure are available to all members meeting medical necessity guidelines regardless of race, color, national origin, age, disability, religion, sex or gender. Preferred dentists agree to accept a negotiated, discounted amount called the Maximum Allowable Charge (MAC) as payment in full for the following services. LTCH's specialize in treating patients who have more than one serious condition yet have the potential to improve with time and care and return to their previous health status. GMMI also offers emergency evacuation services to the nearest facility equipped to adequately treat your condition, translation services, and conversion of foreign medical bills to U.S. currency. Benefits provided under the contract are not assignable by the member to any person without express written approval of the Carrier, and in the absence of such approval, any such assignment shall be void. Surgeryto correct a condition that existed at or from birth and is a significant deviation from the common form or norm limited to children under the age of 18 unless there is a functional deficit. Diagnostic BRCA testing, including testing for large genomic rearrangements in the BRCA1 and BRCA2 genes: Benefits are available for members with a cancer diagnosis when the requirements in the note above are met, and the member does not meet criteria for Preventive BRCA testing. Previously, you were responsible for a $75 minimum for up to a 30-day supply ($210 minimum for a 31 to 90-day supply). If you joined at any other time during the year, your employing office will tell you the effective date of coverage. Note: Medical expenses are not allowable if they occur before the first full month your enrollment is effective, and they are not reimbursable from your HSA until the first of the month following the effective date of your enrollment in this HDHP and the date your HSA account is established. Amid rising prices and economic uncertaintyas well as deep partisan divisions over social and political issuesCalifornians are processing a great deal of information to help them choose state constitutional The benefits in this brochure are effective January 1. General Exclusions Services, Drugs, and Supplies We Do Not Cover, Section 7. Contact us using the customer service phone number listed on the back of your ID card before receiving these types of services, and we will request the medical evidence needed to make a coverage determination: You may request prior approval and receive specific benefit information in advance for non-emergency surgeries to be performed by Non-participating physicians when the charge for the surgery will be $5,000 or more. Prior approval As described on page 107, this program requires that approval be obtained for certain prescription drugs and supplies before we provide benefits for them. CVS Health Eyeglass Repair Kit, For All Eyewear. If the billed amount (or the Plan allowance that providers we contract with have agreed to accept as payment in full) is less than the remaining portion of your deductible, you pay the lower amount. Under certain circumstances, you may also continue coverage for a disabled child 26 years of age or older who is incapable of self-support. You are a family member no longer eligible for coverage. WebCVS Health Accessory Essentials Eyeglass Repair Kit. If the formulary change will lower your cost share for the medication(s), you have the option to speak with your doctor about a prescription for the lower cost alternative. We may delay processing or deny benefits for your claim if you do not respond. Please refer to www.fepblue.org/ddp for a full list of discounted drugs, including those that may be added to this list as they are approved by the U.S. Food and Drug Administration (U.S. FDA). Electronic transmission: You can ask your physician to transmit your prescriptions electronically to CVS Caremark Mail Service Pharmacy. This program is available to the contract holder and spouse who meet the following criteria. Services provided by school systems to children with Autism Spectrum Disorder (ASD) are not reimbursable by the health plan. Generally, you must have been enrolled in the FEHB Program for the last five years of your Federal service. WebAs educators, we see first-hand the impact poor air quality has on our students and their families. See How to obtain preauthorization under Prescription drug benefits. WebChoice and Access of Vision Care Providers UnitedHealthcare offers its vision program through a national network including both private practice and retail chain providers.To access the Provider Locator service or for a printed directory, visit our website myuhcvision.com or call (800) 638-3120, 24 hours a day, seven days a week.United Based on the results of this analysis, we may suggest changes to program benefits to OPM. Refer to the back of your member ID card under the heading, For admissions to Skilled Nursing Facilities, Long Term Acute Care Facilities, or Rehabilitation Facilities pleaserefer to the back of your member ID card under the heading. Services, drugs, or supplies related to abortions, except when the life of the mother would be endangered if the fetus were carried to term, or when the pregnancy is the result of an act of rape or incest. We will update you on new newsroom updates. Note: All outpatient services billed by the facility during the time you are receiving observation services are included in the cost-share amounts shown here. Once you satisfy your calendar year deductible, Traditional medical coverage begins. If you have already met your prior plans catastrophic protection benefit level in full, it will continue to apply until the effective date of your coverage in this Plan. The following illustrates the examples of how much you have to pay out-of-pocket, under the HDHP, for services from a PPO physician vs. a non-PPO physician. You can find more information about how our Plan coordinates benefits with Medicare in our Medicare and You Guide for Federal Employees available online at www.fepblue.org. Covered prescription drugs and supplies not obtained at a retail pharmacy, through the Specialty Drug Pharmacy Program, or, for Standard Option members and Basic Option members with primary Medicare Part B, through the Mail Service Prescription Drug Program. Previously, members could obtain self-injectables either through the pharmacy benefit or through the medical benefit at their doctor or facility office. Note: Once you have purchased amounts of these medications in a calendar year that are equivalent to a 90-day supply combined, all Tier 1 fills thereafter are subject to the corresponding cost-share. Top Company Easy Apply 30d Provides and ensures prompt and courteous member service. Outpatient prescription drugs are not a part of the $100,000 limit. For more information regarding access to PHI, visit our website at www.geha.com/PHI to obtain our Notice of Privacy Practices. There are many other acute conditions that we may determine are medical emergencies what they all have in common is the need for quick action. Below are lists of the top 10 contributors to committees that have raised at least $1,000,000 and are primarily formed to support or oppose a state ballot measure or a candidate for state office in the November 2022 general election. Note: If you are traveling overseas and need assistance with emergency evacuation services to the nearest facility equipped to adequately treat your condition, please contact the Overseas Assistance Center (provided by GMMI) by calling 804-673-1678. Please contact your Tribal Benefits Officer for exact rates. Observation care is a well-defined set of specific, clinically appropriate services, which include ongoing short-term treatment, assessment, and reassessment, that are furnished while a decision is being made regarding whether patients will require further treatment as hospital inpatients or if they are able to be discharged from the hospital. Note: For services performed by dentists and oral surgeons in our Preferred Dental Network, you pay the difference between the amounts listed to the left and the Maximum Allowable Charge (MAC). You must notify us that you are ineligible for an HSA. To determine the amount you may contribute, subtract the amount thePlan will contribute to your account for the year from the maximum allowable contribution. We cover specialty care at designated Blue Distinction Centers at Preferred benefit levels. This is a website provided by the U.S. Department of Health and Human Services that provides up-to-date information on the Marketplace. Biofeedback, educational, recreational or milieu therapy, either in or out of a hospital. Your claim will be calculated on the 25%/40% coinsurance and the appropriate deductible. See your TRICARE or CHAMPVA Health Benefits Advisor if you have questions about these programs. Two Tone Gent's Diamond Band With 5 Roound Diamonds = Approx .50ct tdw, I2 I Retail $2199 / Estate $1099. Custodial or long-term care can also be provided in the patients home, however defined. Note: We only cover a private room if we determine it to be medically necessary. Note: Aspirin, fluoride, bowel prep, generic raloxifene, generic tamoxifen, exemestane, anastrozole, folic acid and generic statins with physician prescriptionare covered as preventive with the appropriate age/gender or dosage limits with no patient copay. Note: You are the only person who has a right to file a disputed claim with OPM. If you change options in this Plan during the year, we will credit the amounts already accumulated toward the catastrophic protection out-of-pocket limit of your prior option to the catastrophic protection out-of-pocket limit of your new option. See Other services that require preauthorization in Section 3. The HSA is portable you may take the HSA with you if you leave the Federal government or switch to another plan. Note: Copayments are waived for members with Medicare Part B primary. WebContact CVS Caremark, our Pharmacy Program administrator, at 800-624-5060, TTY: 711, to request prior approval, or to obtain a list of drugs and supplies that require prior approval. Health Education Resources and Account Management Tools. Your cost-sharing responsibilities are no greater than for other illnesses or conditions. If you decide to enroll in Medicare Part D later, you will not have to pay a penalty for late enrollment as long as you keep your FEHB coverage. Make sure that you review the benefits that are available under the option in which you are enrolled. If you purchase a drug that is not on our preferred drug list, your cost will be higher. These programs and materials are the responsibility of the Plan, and all appeals must follow their guidelines. Note: A residential treatment center is a covered facility for outpatient care (see Section 10, Definitions, for more information). Visit www.HealthCare.gov to compare plans and see what your premium, deductible, and out-of-pocket costs would be before you make a decision to enroll. Preferred Retail Pharmacies When you use Preferred retail pharmacies, show your Service Benefit Plan ID card. Do not rely on this page; it is for your convenience and may not show all pages where the terms appear. The address for the Blue Cross and Blue Shield Service Benefit Plan administrative office is: Blue Cross and Blue Shield Service Benefit Plan1310 G Street NW, Suite 900Washington, DC 20005. Key Findings. See page 63 for our payment levels for circumcision. Your prescription drug program includes use of the CVS Caremark Formulary which is developed by an independent panel of doctors and pharmacists who ensure the medications are clinically appropriate and cost-effective. For those covered services with coinsurance, we pay 100% of our allowable amount for the remainder of the calendar year after your out-of-pocket expenses for deductibles and coinsurance exceed $5,000 for Self Only coverage or $10,000 for Self Plus Oneand Self and Family coverage when you use PPO providers. Assistant surgeons are covered up to 20% of our allowance for the surgeon's charge for procedures when it is medically necessary to have an assistant surgeon. Refer to the back of your member ID card under the heading Prior Authorization for the contact information. The remaining balance is not a covered expense. When you are covered by more than one vision/dental plan, coverage provided under your FEHB plan remains as your primary coverage. Every year, we conduct an analysis of the financial requirements and treatment limitations which apply to this Plans mental health and substance use disorder benefits in compliance with the federal Mental Health Parity and Addiction Equity Act (the Act), and the Acts implementing regulations. Some contraceptives and services are coveredunder the medical benefit; see Section 5(a), Family Planning. If precertification is not obtained or a Plan-designated organ transplant facility is not used, our allowance will be limited for hospital and surgery expenses up to a maximum of $100,000 per transplant. You may go to any doctor, specialist, or hospital that accepts Medicare. We will now cover Rhogam at 100% of the Plan allowance (after the calendar year deductible). or licensed doctors of osteopathy (D.O. Prescribed by your physician (i.e., the physician who is treating your illness or injury); A drug, device, or biological product that cannot be lawfully marketed without approval of the U.S. Food and Drug Administration (U.S. FDA); and approval for marketing has not been given at the time it is furnished; or, Reliable evidence shows that the healthcare service (e.g., procedure, treatment, supply, device, equipment, drug, biological product) is the subject of ongoing phase I, II, or III clinical trials or under study to determine its maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with the standard means of treatment or diagnosis; or, Reliable evidence shows that the consensus of opinion among experts regarding the healthcare service (e.g., procedure, treatment, supply, device, equipment, drug, biological product) is that further studies or clinical trials are necessary to determine its maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with the standard means of treatment or diagnosis; or. See page 32, NSA, for information on when you are not responsible for this difference. 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