SIGIS: Special Interest Group for IIAS Standards™
Eligible Product List Criteria (12/14/2011)
IMPORTANT NOTICE:
In August 2011, Donna Crisalli, Special Counsel to the Associate Chief Counsel, IRS, clarified (in her non-binding, informal remarks) that in her opinion, there was no reason to use sunscreen other than to prevent sunburns, so again in her opinion, it is eligible. This is further supported by a recent FDA release in which sunscreens labeled as both “Broad Spectrum” and “SPF 15” (or higher) not only protect against sunburn, but, if used as directed with other sun protection measures, can reduce the risk of skin cancer and early skin aging. As a result, the List Criteria Document is amended for sunscreen and sunblock products that can be clearly identified as SPF 15 or higher and that provide protection against both ultraviolet B radiation (UVB) and ultraviolet A radiation (UVA). These products will not require an Rx for purchase with a health care debit card at SIGIS certified merchants. The full FDA criteria can be viewed at: http://www.fda.gov/forconsumers/consumerupdates/ucm258416.htm
Effective November 2011, the number of DME products was expanded. While Durable Medical Equipment (DME) is an eligible medical expense under IRS Code Section 213(d), it has been difficult in the past to include these items on the Eligible Products List. Two factors drive this: 1) much of the equipment is purchased under a rental / lease arrangement and 2) many manufacturers do not provide UPC codes on their equipment. Recent improvements by manufacturers to bar code their products, have allowed SIGIS to include more of these items on the Eligible Products List.
In addition, recognizing the provision of health care services in many pharmacies and stores such as flu shots, other seasonal vaccinations, and some urgent care services, the Eligible Products List has been modified to allow merchants to include in the IIAS health care total, for these types of eligible health care services.
SIGIS has developed a list of health care over-the-counter items and other services that are considered eligible under Internal Revenue Service (IRS) Code Section 213 rules. The list originates from a database of more than 55,000 health and beauty aid items that is continually being updated with new product introductions and discontinuations. Using the criteria in this document, SIGIS determines whether a product or service qualifies or does not qualify as a medical expense under IRS Code Section 213(d) and applicable IRS guidance. This list is reviewed monthly by the SIGIS List Working Group, a group of benefit plan administrators, to assure the accuracy and integrity of the list. Additions and suggested eliminations from the list are to be referred to the Working Group for monthly discussion and appropriate action.
The Eligible Product List and regular updates may be downloaded and used by all SIGIS members. Merchants certified by SIGIS or planning to be certified by SIGIS must use the Eligible Product List as a basis for identifying the items in their product database that would be eligible for submission as a SIGIS qualified healthcare product in a debit card authorization request. Benefit plan administrators may find the Eligible Product List and this List Criteria helpful in ensuring consistency between substantiation of card transactions at SIGIS merchants and other substantiation requests.
Information provided in this document is subject to change as new information becomes available and as rules and definitions change.
1. Eligibility Status Definitions
Eligible Services for IIAS Approval
Eligible services for inclusion in the IIAS total include the provision of health care services including diagnostic tests, flu shots and other vacinations and urgent care or primary care office visits including services provided at pharmacies or stores.
Eligible Products for IIAS Approval
Eligible OTC: Eligible products include OTC products that are for medical care and are primarily for a medical purpose. They include products (other than OTC medicines or drugs) that diagnose, alleviate or treat existing or imminent injuries, illnesses or medical conditions. As a general rule, most of these products are of short-term use but some do treat chronic medical conditions. Qualified medical expenses include those over-the-counter items compliant with federal tax rules under IRS Code Section 213(d) as outlined by the Internal Revenue Service. In these cases, the expense would not have been paid “but for” the disease or illness. An expense is not deductible as medical care if the taxpayer would have paid the expense even in absence of a medical condition. The user does not need to provide a statement from a medical provider or indicate a diagnosis in order to receive reimbursement.
Prescribed Drugs and Medicines, including Prescribed OTC: Drugs and medicines prescribed by a licensed medical professional and dispensed in accordance with state laws including the generation of an Rx Number are considered Eligible by the IRS. This includes OTC Drugs and Medicines other than dual-purpose. Since the prescription serves as determination of medical eligibility in a merchant location with a properly configured Pharmacy and IIAS POS System, no additional checks are required. These items will not be listed on the Eligible Products list due to their separate processing rules.
Not Included as Eligible Products for IIAS Approval
All OTC Medicines and Drugs without a Prescription: OTC drugs and medicines can only be reimbursed with a valid physicians' prescription. FSA and HRA debit cards can be used only if the OTC drug or medicine is filled by the pharmacist and an Rx number has been assigned. As such, they have been removed from the Eligible Products List as the list only covers items where a prescription is not required by IRS regulations.
Dual-purpose: Some products are considered dual-purpose. These products may have both a medical purpose and a personal hygiene, cosmetic or general health purpose. In order to be considered eligible, they must be used to treat a medical condition and cannot be used to improve or maintain general health unless prescribed by a physician to treat a specific illness, condition or injury. These products may be eligible for reimbursement, but require a letter of medical necessity from a licensed healthcare professional stating the specific diagnosis or medical condition, the specific OTC medicine recommendation to treat the condition, and documentation of the product and cost. Dual-purpose items will not be included in the SIGIS List.
Ineligible: Products that are used for general health, cosmetic, or personal hygiene purposes are not reimbursable. Typically, these are not referred to as medicines or drugs and are not recognized to treat a medical condition. Expenses that are not reimbursable under IRS Code Section 213(d) of the federal tax code are ineligible. These include food supplements, toiletries, lotions and soaps, shampoos, vitamins and most herbal supplements.
The source of the list includes most nationally-distributed, regularly-stocked items. As such, the following types of items will generally not be included: items specially created for an individual retailer (including but not limited to private label items); a local, regional, or specialty item; bonus items (e.g. 2 oz free); BOGOS (buy one, get one), or other in-and-out types of packaging with limited availability or distribution. Although these items will not be included in the data, they may in fact be eligible. If such circumstances exist or if one feels other items meet the eligibility criteria then they can be submitted through the add process on the SIGIS website. These will be reviewed by the SIGIS List Working Group and qualifying items will be added to the eligible product listing.
Because the source of the list is nationally-distributed, regularly-stocked products, private label and store branded products will generally not be available for inclusion on the standard list produced by SIGIS. It is understood that some of these private label and/or store brand items are, in fact, eligible under IRS Code Section 213(d), and therefore, can be processed through a certified SIGIS IIAS merchant. Merchants that choose to supplement their inventory of SIGIS identified eligible items with their own private label items are free to do so by following the process detailed in the Private Label Eligibility Criteria document. That document can be found at www.sig-is.org.
2. Classifications and Examples
The following are types of products that typically would be included under each designation. These are strictly guidelines and do not represent an all-inclusive listing.
Eligible:
| Category | Example | Comment |
| Breast Pumps and Breast-Feeding Supplies | Breast Pump (cost or rental fee), Breast Pump Parts (pump valve, replacement tubing, piston unit, diaphragms, pump body, flange, shield), Gel Pads, Nipple Shields, Conversion Kits, Areola Stimulator, Car Adapter | Eligible for lactating women. Items not eligible include: Bottles, Bottle Stands, Bottle Nipples, Storage Bags, Cleaners, Freezer Blocks, Bra Shields and Nursing Pads, Pillow and Covers, Nursing Bras, Coolers |
| Contraceptives | Unmedicated condoms (e.g., condoms without spermicide) | |
| Cotton Balls | | Sterile only is eligible, non-sterile are considered dual-purpose |
| Denture Adhesives, Repair, and Cleansers | PoliGrip, Benzodent, Plate Weld, Efferdent | Denture products and maintenance covered |
| Diabetes Testing & Aids | Ascencia, One Touch, insulin syringes; glucose products | Include glucose tabs/gels, testing and insulin related accessories |
| Diagnostic Products | Thermometers, blood pressure monitors, cholesterol testing | Includes devices that monitor, screen or test for the presence of disease, dysfunction of the body or for other medical conditions; drug and body fat testers are not covered (dual) |
| Diagnostic Testing | Chloresterol screening | |
| Durable Medical Equipment | Wheel Chairs, Crutches, Oxygen Machines | Can be included when manufacturer provides UPC, merchants can mark non-UPC tagged items as private label items |
| Ear Care | Unmedicated ear drops, syringes, and ear wax removal | |
| Elastics/Athletic Treatments | ACE, Futuro, elastic bandages, braces, hot/cold therapy, orthopedic supports & rib belts, etc. | Waist shapers, tummy supports and work related back braces are not covered (dual) |
| Eye Care | Contact lens care | |
| Family Planning | Pregnancy kits, ovulation kits | |
| First Aid Dressings & Supplies | Band Aid, 3M Nexcare, J&J First Aid, non-sport tapes, etc. | Tapes and bandages indicated as "Athletic" or "Sport" are not covered |
| Foot Care Treatment | Un-medicated corn & callus treatments (e.g., callus cushions), devices, therapeutic insoles | Products that treat specific ailments are eligible; products for general use or comfort are not eligible (dual) |
| Glucosamine &/or Chondroitin | Osteo-Bi-Flex, Cosamin D, Flex-a-min Nutritional Supplements | Medical expense as long as products marketed for arthritis treatment (as opposed to mere prevention) |
| Health Care Services | Urgent Care or Primary Care services provided by a licensed practitioner at an IIAS merchant | |
| Hearing Aid/Medical Batteries | | |
| Home Health Care (limited segments) | Ostomy, walking aids, decubitis/pressure relief, enteral/parenteral feeding supplies, patient lifting aids, orthopedic braces/supports, splints & casts, hydrocollators, nebulizers, electrotherapy products, catheters, un-medicated wound care, wheel chairs | |
| Incontinence Protection & Treatment Products | Attends, Depend, GoodNites for juvenile incontinence, Prevail | Skin and cleansing products not covered (dual) |
| Prenatal Vitamins | Stuart Prenatal, Nature's Bounty Prenatal Vitamins | |
| Reading glasses and maintenance accessories | | Accessories used to maintain corrective lenses and frames are covered; chains, etc. not covered |
| Sun Protection (SPF 15+ and "Broad Spectrum") | Coppertone, Banana Boat SPF 15+ and UVA / UVB protection | Protection against skin cancer and premature skin aging |
| Vaccinations | Flu Shots, Pneumonia Vaccinations | |
Dual-purpose (Not Included in Eligible Product List):
| Category | Example | Reimbursement Use |
| Allergy Pillows, Mattress Covers, Air Purifiers, Filters, etc. | | To treat allergies diagnosed by physician |
| Anti-bacterial Hand Sanitizers | Purell, Nexcare, Germ-X | Personal use component; but/for test must be established |
| Baby Diapers | Huggies, Pampers, Pullups | To treat juvenile incontinence or medical condition |
| Baby Formulas/Nutritionals | Pediasure, Progestimil | Only specialty formulas/nutritionals are covered if medically necessary and authorized by medical practitioner. Only the excess cost between regular formula and the specialized forumla may be eligible under an employer's plan. |
| Compression Hosiery | Jobst, TED, Futuro | Including diabetic socks; excess cost over regular hose and socks |
| Cough, Cold & Flu dietary supplements | Airborne, Hall's Defense, Germ Defense Alka Seltzer Immunity | Products that are merely dietary supplements and marketed as such, including those claiming to "support the immune system" (i.e. Airborne), are not covered (dual). Cold preventative products which are "proven to lessen the severity" or "reduce the duration" of colds or flu are covered. These include homeopathic, natural products, some herbals and some forms of zinc. |
| Diabetes Nutritionals | Glucerna, Boost Glucose | To treat symptoms of diabetes when recommended by physician |
| Diabetes Personal Care & Supplies | Include diabetes skin care, cough & cold, support socks and supplies | Personal care is generally not covered; must test or treat a specific symptom or condition of Diabetes |
| Dietary Supplements | Essential fatty acids (fish oil), soy, enzymes, amino acids | Under narrow circumstances, they will be eligible if used to treat medical condition or at-risk for illness diagnosed by physician; dietary supplements marketed in pain relief, cough & cold and antacids/laxative categories do not automatically qualify as a medical expense (i.e. Azo Cranberry, Airborne, Culturelle, etc.) |
| Drug Testing Kits | First Check | Diagnostics of illegal activities are typically not covered |
| Ear plugs | Mack's, Flents | To treat medical condition (presence of middle/inner ear tubes) diagnosed by physician |
| Exercise Equipment | Treadmill, exercise bike | To treat medical condition diagnosed by physician & not for general health |
| Face Masks - medical grade | | Personal use component; but/for test must be established |
| Feminine Moisturizing | Replens, Rephresh | To treat vaginal dryness caused by medical condition |
| Feminine Protection (Pads & Liners) | Kotex, Always, Stayfree | They are ordinarily considered as being used to maintain general health and for personal care. They are dual if used for post-surgery or child birth |
| First Aid Burn & Scar Treatments & Skin Protectants (petroleum jelly) | Aloe, Mederma, Neosporin Scar Solution, Vaseline Jelly | Most are cosmetic in nature or have general use purposes |
| Fluoride Treatments | Gel-Kam | To treat medical condition diagnosed by physician & not for general oral care |
| Food Thickeners | Thick-It | Personal use component; but/for test must be established |
| Foot Insoles and Cushioning | Insoles, Heel & Arch, Dr. Scholl's Air Pillo, Odor Eaters | Treatment vs. general use or comfort; must treat specific ailment to be covered |
| Gloves (Rubber & Cotton) | Becton, Dickinson and Co (BD) | |
| Hair Growth Products | Rogaine | To treat symptom of medical condition diagnosed by physician |
| Herbals & Botanicals | Echinacea, ginkgo biloba, garlic | Under narrow circumstances, they will be eligible if used to treat medical condition or at-risk for illness diagnosed by physician |
| Home Health Care (limited segments) | | Home Health Care is dual other than what is indicated in the Home Health Care eligibility section |
| Incontinence Personal Care | Perineal cleansers, moisturizers and general skin protectants | Personal care is generally not covered; must treat a specific symptom or condition of Incontinence |
| Magnifying Glasses | | |
| Medical Nutritionals | Resource, Peptamen, Nutren | Satisfies normal nutritional needs and does not treat a specific condition |
| Medicated & Specialty Soaps | Basis Bar, Cetaphil Cleansing Bar | To treat skin condition diagnosed by physician |
| Minerals | Calcium Carbonate, Ferrous Sulfate, etc. | Under narrow circumstances, they will be eligible if used to treat medical condition or at-risk for illness diagnosed by physician |
| Nasal Strips & Snore Relief | Breathe Right | To treat sleep apnea or improper breathing diagnosed by physician |
| Nutritional Foods | Ensure, Boost | To treat medical condition diagnosed by physician & not for general health |
| Probiotics and Prebiotics | Culturelle, Florastor | To treat digestive condition and recommended by physician & not for general digestive health |
| Skin Care - Therapeutic Hand & Body | Eucerin, Aquaphor, Amlactin | To treat or remedy a skin condition diagnosed by physician |
| Sun Protection (SPF 15+) | Coppertone, Banana Boat SPF 15+ | Diagnosis or history of skin cancer that is affected by sun exposure |
| Therapeutic Shampoo & Scalp Treatments (Medicated) | Nizoral, Neutrogena T-Gel | To treat skin/scalp condition for short duration diagnosed by physician |
| Vaporizers & Humidifiers and Accessories | Vicks, Sunbeam, Kaz | Covered if used to treat illness; not covered for normal household use |
| Vitamins | Vitamin A, C, D, E, multivitamin, lutein eye vitamin | Under narrow circumstances, they will be eligible if used to treat medical condition or at-risk for illness diagnosed by physician |
| Weight Control Supplements | Alli, Slim Fast | To treat obesity diagnosed by physician |
OTC Medicines and Drugs (Not Included in Eligible Product List):
| Category | Example | Comment |
| Acid Controllers | Pepcid AC, Zantac, Prilosec | |
| Acne Medications | Clearasil, OXY | |
| Allergy & Sinus | Alavert, Benadryl, Claritin, Sudafed | |
| Antibiotic Products | Bacitracin, Neosporin, triple antibiotic ointment | |
| Anti-Diarrheals | Imodium, Kaopectate | |
| Anti-Gas | Gax-X, Phazyme | Unclear whether digestive aids with enzymes as an active ingredient are “medicine” or “drugs” |
| Antifungal (Foot) | Lamisil, Lotrimin | |
| Anti-Itch & Insect Bite Remedies | Caladryl, Lanacane, Sarna, hydrocortisone | |
| Antiparasitic Treatments | Nix, Rid, lice treatments | |
| Antiseptics & wound cleansers | Rubbing alcohol, peroxide, epsom salt, Betadine, Hibiclens | |
| Baby Electrolytes and dehydtration | Pedialyte, Enfalyte | Baby Electrolytes and dehaydration |
| Baby Rash Ointments & Creams | Desitin, Aveeno Baby | Includes petroleum jelly merchandised and marketed for baby rash |
| Baby Teething Pain | Baby Orajel, Anbesol Baby Oral Gel | |
| Cold Sore Remedies | Abreva, Herpecin, Orajel | Only medicated products are covered |
| Contraceptives | "Morning-after pill", female contraceptives, spermicidal foam, medicated condoms | |
| Cough, Cold & Flu | Robitussin, Theraflu, Vicks, Halls, Cepacol, Zicam, Cold-Eeze | Cold preventative products which are "proven to lessen the severity" or "reduce the duration" of colds or flu are covered. These include homeopathic, natural products, some herbals and some forms of zinc. Products that are merely dietary supplements and marketed as such, including those claiming to "support the immune system" (i.e. Airborne), are not covered. Hand sanitizers in cold not covered. |
| Denture Pain Relief | | |
| Digestive Aids | Lactaid, Lactase, Beano, | Unclear whether digestive aids with enzymes as an active ingredient are “medicine” or “drugs” |
| Ear Care | Medicated ear drops, Debrox, Similasin | |
| Eye Care | Visine, Refresh Tears | |
| Feminine Antifungal and Anti-itch | Monistat, Gyne-Lotrimin, Vagisil, Soothing Care | |
| Fiber Laxatives (bulk forming) | Benefiber, Fibercon, Metamucil (powder or pills) | Covered when used to treat a medical condition for short duration; bars and drinks that are "nutritional foods" for help with regularity are not covered (dual) |
| First Aid Burn Remedies | Dermoplast, Solarcaine | Must contain an antiseptic or pain reliever, 100% aloe is not covered (dual) |
| Foot Care Treatment | Corn & callus treatments, wart removers | Products that treat specific ailments are eligible; products for general use or comfort are not eligible (dual) |
| Hemorrhoidal Preparations | Preparation H, Tucks | |
| Homeopathic Remedies | Boiron and Hyland products | Homeopathic medicine is a form of alternative medicine that uses very small amounts of natural substances, which in higher amounts would cause a disease. The theory behind homeopathic medicine is that "like cures like," and that a substance that causes an illness in a healthy person might cure those symptoms in someone who is ill. Such products that treat an illness or condition are eligible with a prescription. |
| Incontinence Protection & Treatment Products | Anti-fungals, Calmoseptine | Skin and cleansing products not covered (dual) |
| Laxatives (non-fiber) | Dulcolax, Ex-Lax, Miralax | Stimulant, saline, lubricant, etc (non-fiber) |
| Motion Sickness | Dramamine, Sea-band Wristband, Bonine | |
| Medicated Nasal Sprays, Drops & Inhalers | Afrin Spray | |
| Oral Remedies or Treatments | Saliva substitutes, mouth sore treatments, dental repair, Salivart, Anbesol, Orajel, Dentemp | Only dry mouth that are saliva substitutes are covered (gels, sprays, etc. not mouthwash, rinses, toothpaste) |
| Pain Relief (includes aspirin) | Tylenol, Advil, Midol, Bayer | |
| Medicated Respiratory Treatments and Vapor Products | Primatene, Bronkaid, medicated Vics Vapor Rub | Includes asthma medications and delivery devices like inhalers and nebulizers; vaporizers and humidifiers not covered (dual) |
| Skin treatments | Psoriasin, MG217, Dermarest Eczema | Medical expense as long as intended purpose is to treat existing skin conditions like eczema, psoriasis, rosacea, etc. (as opposed to mere prevention) |
| Sleep Aids & Sedatives | Unisom, Nytol, Sominex | |
| Smoking Deterrents | Nicoderm, Nicorette | |
| Stomach Remedies | Mylanta, Maalox, Tums | |
| Unmedicated Nasal Sprays, Drops & Inhalers | Ocean Nasal Spray | |
| Unmedicated Vapor Products | Sudacare, unmedicated Vicks Vapor Rub | Includes asthma medications and delivery devices like inhalers and nebulizers; vaporizers and humidifiers not covered (dual) |
Other Ineligible Products:
| Category | Example | Comment |
| Baby Toiletries, Baby Oil, Powder, Lotions & Creams | Johnson's Baby oil/Powder, Aveeno Baby Lotion | |
| Beauty Shampoos, Conditioners & Hair Treatments | Pantene, Suave, Dove, hair color | |
| Cosmetics | Revlon, CoverGirl | |
| Deodorants | Speed Stick, Degree | |
| Facial Cleansers | Neutrogena Deep Clean, Dove Facial Cleanser | |
| Feminine Cleansing Products | Massengill, Summer's Eve | |
| Foot Grooming | Implements, beauty & comfort, moisturizers, odor & wetness | Non-medicated |
| Hair Removal & Bleaches | Nair, Veet | |
| Hand & Body Cleansing | Dove, Dial soap | |
| Lip Preparations | ChapStick, lip balm | |
| Oral Care | Toothpaste, toothbrush, mouthwash, breath remedies | Will not qualify even if a dentist recommends a special product to treat a medical condition like gingivitis. These are primarily used to maintain general health. |
| Shaving & Men's Grooming | Gillette, Schick | |
| Skin Care | Moisturizers, hand & body, bath products | |
| Sport Energy Liquids, Bars, etc. | Gatorade, EAS drinks/bars | |
| Sugar & Salt Substitutes | Equal, Splenda | |
| Sun Tanning | Sun tan lotion, after sun products that are less than SPF 15 and/or that do not offer "Broad Spectrum" coverage | Do not meet the minimum FDA standard for prevention of skin cancer or premature aging |
3. Reporting items to include or delete
SIGIS members can use the Missing Product Form to request items to be added or deleted. Incomplete information will not be considered.
4. List Availability
The list is generally available by the 9th business day of each month. Items for the List Review Working Group to be considered for addition or deletion from the SIGIS List must be submitted by the 1st business day of each month to be considered for that month’s updates.
5. Notes:
It has been reported that some merchants are unable to include a SIGIS eligible healthcare product that may also be eligible for purchase via the Food Stamp program. Should this present a problem for any merchants, it is recommended that they should eliminate it from the SIGIS data and classify it for Food Stamp eligibility, as the consumer may submit the item for manual reimbursement from their flexible spending or health reimbursement arrangement account.
Updated December 14, 2011
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