Eligible Product List Criteria

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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