By: Raenette Franco, CEO/CBCS/Founder
Certified Biller Coder Specialist/Consultant
Compassion Works Reimbursement Specialists
Compassion Works Medical, LLC
“Your rescue for coverage”
Phone: (973) 832-4736
Fax: (973) 387-1223

Presentation: Medical Food and Supplements Insurance Coverage

The complexity of the health care system can overwhelm even the savviest patient and/or clinical professional. That is why Compassion Works Medical was created to hold hands with patients and alleviate the clinics time through the difficult process of medical food insurance coverage.
Compassion Works Medical is founded by Raenette Franco, CEO and Certified Billing and Insurance Specialist. Raenette has been inspired to share her hands-on experience with medical foods insurance coverage specialized in all types of inherited metabolic diseases and rare genetic disorders. Compassion Works Medical works with you and for you, providing guidance and supporting you with compassion and integrity.  Ms. Franco specializes only in medical food coverage and has been battling insurance coverage for medical foods for over a few years in addition to fighting for the Medical Nutrition Equity Act on Washington’s’ DC Capitol Hill. Compassion Works Medical collaborates with patients’ current insurance policies, and fights for state mandated coverage.
Every case is unique and different.  Understanding your options and insurance terminology is essential to obtaining the coverage that you deserve!
Let’s start with the basics………….
What is a Medical Food? You may hear these words often and could be confusing to the words “formula” or “dietary supplements”.

  • Medical foods are foods that are specially formulated and processed (as opposed to a naturally occurring foodstuff used in a natural state) for a patient who requires use of the product as a major component of a disease or condition’s specific dietary management (i.e. designed for a certain disease) and intended to be used under medical supervision.
  • Formula is basically the same thing as a medical food as they are made from the building blocks of foods.
  • Dietary supplements are not generally designed for a certain disease, but are used in contribution to maintain a disease such as added vitamins. Dietary supplements are sometimes added to patient’s dietary management.
  • What is Enteral? Enteral is a medical term used for a feeding method either oral or tube feeding; Hence Enteral formula.

Overall Medical foods, dietary supplements and enteral formula are common words uses for insurance coverage.
Coverage for medical foods and dietary supplements are generally covered under medical benefits and supplied by a durable medical equipment (DME) distributor by using the description of coverage. However, medical foods are also covered under pharmacy benefits by product only, just a little tougher to maneuver insurance coverage.
Coverage for special injectable vitamins: Are you or your family member on injection vitamins such as cyanocobalamin/hydroxocobalamin ML (B-12)? If yes, coverage for this special vitamin could be challenging. This special injectable vitamin may or may not be covered under pharmacy benefits. Some pharmacy benefits does not cover these products and considered over the counter. To obtain coverage, it requires jumping through loop holes.  However, the health insurance benefits for cyanocobalamin/hydroxocobalamin ML could be covered under your medical benefits.  Since the skin is pinched or broken such as with an injection and the place of service is at your clinic. If your clinic could administer the vitamin and bill your insurance company, it would be the best affordable route.
The insurance language under medical benefits for Hydroxocobalamin ML use HCPCS code J3420 and for Pharmacy benefits it is under an NDC number (i.e. 00591-2888-30). The place of service is at the office – Usually injected at the physician’s office under medical benefits.
Insurance coverage tips…………………
To start investigating coverage for your dietary management, it is recommended to start with your medical benefits first. Sometimes when we get a prescription we automatically think it’s a pharmacy benefit and that’s natural, however, if you have a prescription for medical foods or dietary supplements it’s best to check with your medical benefits first.
Here are eight tips below to better understand your medical food and dietary supplement insurance coverage:
Rule No. 1: Never take NO for an answer!

  1. Insurance Terminology                                               
  2. Difference between Medical and Pharmacy coverage 
  3. Reimbursement issues between insurance company and supplier    
  4. Verifying Insurance Benefits before placing an order
  5. Medical Food Exclusion Removal
  6. Gap Exceptions for policies with no out-of-network benefits
  7. Be prepared for a prior authorization before covered services                                   
  8. Got Medicare or Medicaid? Best Avenue for medical food coverage.

It’s important to understand your health plan’s guidelines for medical food coverage by thoroughly reading through your health plans summary of benefits to find out if your medical foods and dietary supplements are covered. Start by looking under durable medical equipment benefits (DME) and non- covered services including exclusions. Key words: ENTERAL, MEDICAL FOODS, NUTRITION, FORMULA, SUPPLEMENTS.

  1. Insurance Terminology: Medical food and dietary supplements coverage is a complete foreign language to the health insurance industry. There are certain terminologies used to help obtain the most accurate coverage details with your health plan’s benefit specialist such as;
    1. Service codes (also known as HCPCS codes) used to describe the medical foods, enteral formula, dietary supplements and vitamins (i.e. B4155, B4157, B4162, B9998, S9435, S9435, J3420). These codes could be administered orally, tube feeding or vitamin injection. Injections are usually done at the clinic and not at home for proper coverage.
    2. In-network and out-of-network to help determine the most affordable way to obtain your dietary needs. Also known as participating or non-participating.
    3. Know the difference between prior authorization and predetermination. Prior authorization is required before coverage and predetermination is not required before coverage, but helps avoid any future denials.
    4. Diagnosis driven plan: This is a plan that will only cover if the diagnosis code such as your medical condition(s) matches the description of service. Your diagnosis codes starts with a letter (i.e. ICD-10: E71.121). If it matches then you are covered. Diagnosis driven plans are easily mistaken as not covered, so if your benefit specialist mentions that it’s not covered ask if your plan is diagnosis driven.
    5. Other words are exclusions, out-of-pocket, state mandated plans, deductibles, fully insured, self-funded, allowed amounts, suppliers, gap exceptions.
  2. Difference between Medical and Pharmacy coverage: Typically medical foods and dietary supplements are generally covered under your medical benefits and provided by a DME distributor. The medical benefits cover by using the service codes and the diagnosis code. Pharmacy benefits cover by the product alone and not the service. Medical foods and dietary supplements could be challenging for coverage under pharmacy benefits, if the product is not listed in their system and considered over the counter it’s not covered. If you pharmacy plan does not cover your product, then use you medical benefits or file for an appeal.
  3. Reimbursement-Billing issues between insurance company and supplier: Receiving bills from your providers could be scary. Don’t panic! First make-sure you if you’ve received a bill from your provider or is it an Explanation of Benefits- EOB statement (not a bill) from your insurance company. Check your EOB and match it with your invoice to determine if the bill is for your deductible or co-insurance. If not, contact your provider immediately and go over your invoices. Look out for any unnecessary charges.
  4. Verifying Insurance Benefits before placing an order: The best way to avoid delays with your medical food orders are to try to verify your benefits and coverage “first” with your insurance carrier before placing an order. Contact your insurance carrier and ask for benefit coverage for Medical Food/Enteral Formula or nutritional supplements. Include diagnosis code (ICD-10). Mention it’s “usually covered under DME”. Remember to ask if the plan is diagnosis driven to avoid any misunderstandings.
  5. Ask for any exclusion on your policy for medical foods; if there are any exclusions that does not cover your medical foods, it is not the insurance company that you would fight with. This is out of their hands. You will have to go to you employers HR department and ask for a medical food exclusion removal and present your letter of medical necessity explaining your rare genetic disease. Medical food removal template letters can be found at Compassion Works Medical. To make a request, email
  6. What is a Gap Exception?  A coverage gap exception is a waiver from a healthcare insurance company that allows a customer to receive medical services from an out of network provider at an in network rate. Usually HMO or EPO plans do not have out-of-network benefits, but if you can’t find an in-network provider to supply your medical foods, you could ask your insurance carrier for a gap exception. Also, your out-of-network supplier could request a Gap exception to your insurance company directly. This way is easier!
  7. One of the best reasons for your waiver is that there aren’t any other in-network providers within 100 miles of your residence that can supply your medical foods. Another is that you prefer to use the out-of-network provider because of a strong long-lasting and trusting previous relationship.
  8. Any request is worth a shot! This also saves time for your out-of-network supplier as well as providing faster medical food service.
  9. Be prepared for a prior authorization that is required by your insurance carrier: some policies require prior authorizations from your insurance company before they will cover. Prior authorizations need to be identified as “medical necessary”. This is usually provided by your clinic or medical food supplier. Make sure your clinic provides you a letter of medical necessity (LMN) with a prescription and recent progress notes (A.K.A. clinical notes). Your provider usually makes these requests.
  10. Stay on top of your prior authorization approvals. When they expire, you or your provider will have to request a renewal. This depends on your policy; i.e. month to month, every 3 months, yearly, etc.
  11. Do you have a government plan such as Medicaid or Medicare? As most of you already know, Medicaid usually follows all of the state mandated laws and covers 100% for in-network providers and may require a prior authorization. Medicare straight from your state does not cover medical foods “UNLESS fed by a feeding tube and is the sole source of nutrition”.
  12. Want Medicare Coverage?: If you have already have Medicare you can switch to a Managed Medicare Plan in your state such as AARP, UHC, BCBS, Humana, etc. and they could provide your medical food coverage. You may not have to pay any extra premiums. Many patients are able to be covered through their managed Medicare plans.  This is NOT a Supplement Plan; it is a Managed plan that has leniency for medical food coverage. Supplement plans only follow the Medicare straight state plans. Supplement plans will have the word “supplement” on your card or “Complete” .Make sure that your plan is not a supplement as they follow Medicare guidelines. To find a managed Medicare plan in your state by visiting Or simply call member services listed on the back of your Medicare card for assistance.

An extra bonus tip ***: From my experience if you are looking for a reliable dietary supplement, medical food and vitamin supplier for all types of rare genetic disorders, I suggest checking out Solace Nutrition, LLC . They are very unique and provide most dietary supplements that you cannot find anywhere else. Ask your provider to search their website for the most appropriate supplement that could help you and your family member’s dietary management. Also, most of their products are covered by some insurance companies.
In addition: If you or a family member has an inborn error of metabolism disease such as PKU, TYR, HCU MSUD, I suggest checking out this unique European company POA Pharma North America .Their products are also very distinctive comparing to other markets in the USA. Also, most of their products are covered by some insurance companies.
I have experienced success with patients affording products from Solace Nutrition, LLC and POA Pharma North America.
The tips above are based on actual experiences. I believe there are no true experts with all of the answers.
So let’s face the facts, patients NEED an Advocate, preferably someone with a medical food-insurance background.  Patients need champions who can: (1) TRANSLATE what’s being told (2) ASK THE RIGHT QUESTIONS that patients ‘don’t know to ask’ (3) COMMUNICATE upwards, downwards and sideways.
For support and questions on medical food insurance coverage for all types of Inherited Metabolic Diseases and rare genetic diseases, please contact Compassion Works Medical at
(973) 832-4736; email

​Health insurance coverage for OAA medical-nutritional treatments

By: Keiko Ueda, MPH, RD, LDN
(OAA’s Medical Advisor)

Unfortunately obtaining and maintaining health insurance coverage of medically necessary monthly refills of; metabolic formulas, specialty low protein foods, medical supplies, and medications, continue to be a challenge for most families living with organic acidemias (OAs).  Many of the suggestions originally published in the Jan 2003 OAA newsletter(1) article continue to be applicable and hopefully still helpful to families obtaining or maintaining coverage by health insurance providers. 

Virgina Schuett, MS, RD on her National PKU News PKU legislation and policies webpage2 (updated 1-06) has compiled data on 48 US states of which; 34 states have  state laws (3 states listed as pending legislation), 11 states listed without state laws, and 24 states with state assistance programs. Of the 34 state laws listed, 6 state laws mandate coverage for people living with Phenylketonuria (PKU) only and 27 states laws mandate coverage for PKU and other metabolic disorders which may or may not include all OAs. There are often important differences in state laws and eligibility requirements for enrollment into state assistance programs. If you are a resident in a state with a state law then obtain a copy of your state’s law for your files.  If you do not currently have a copy, ask your metabolic clinic staff to provide you with a copy of your state law and/or contact your state’s bill library to request a copy. If your state offers a state assistance program, ask your metabolic clinic staff if you/your child is eligible to enroll in your state’s program.

Denials of coverage by health insurance providers seem inexplicable to metabolic clinic staff, even moreso for families and people living with OAs, especially as medical and nutritional treatments are universally accepted as the current standard of medical care for the treatment of OA disorders. 

Why Denials?

When a denial is obtained, it is important to ask your health insurance to clarify exactly why the authorization request for coverage was denied. This information will best help you and your metabolism clinic and/or primary care provider to know what additional medical information should be provided for the appeals process with your health insurance provider. The reasons always seem to boil down to the basics:

  1. Lack of knowledge/awareness about rare metabolic disorders and the medical necessity for uncommon and therefore expensive medical-nutritional treatments
  2. Lack of consistent medical billing systems allowing for the appropriate billing and reimbursement to medical supply companies and pharmacies

Case example:  Infant newly diagnosed with a metabolic disorder born in Massachusetts, metabolic clinic staff submitted a medical necessity letter and prescriptions for metabolic formulas to request approval of coverage by infants’ health insurance provider.  MA state law(3) mandates coverage for patients diagnosed with inherited diseases of amino acids and organic acids by health insurance providers of metabolic formulas. MA state law also mandates additional coverage for specialty food products modified to be low protein limited to $2500 per year. Health insurance nurse case manager responds with approval of coverage of metabolic infant formula but parents told that formula coverage is limited to $2500/year. Parents informed that the infant’s metabolic formula was interpreted to be the same as a low protein food and not a medical food.  This $2500/year cap on formula coverage would only provide the infant with ~5-6 months of metabolic formula refills. Metabolic dietitian provided additional documentation that infant’s medically necessary metabolic formula is actually a high protein formula, but metabolic disorder specific amino acid-free medical food as defined by the US FDA. “A medical food is prescribed by a physician when a patient has special nutrient needs in order to manage a disease or health condition, and the patient is under the physician’s ongoing care. The label must clearly state that the product is limited to be used to manage a specific medical disorder or condition.(4)   Infants’ health insurance medical director reviewed additional information provided and approved metabolic formula coverage for infant as prescribed without an annual limit.

What? OA Spelling ABC’s

If you are a resident in a state with a state law, always use the same terms written into your state law in conversations and correspondence with your health insurance customer service/nurse case managers.  Always state the full name of your OA disorder and provide the correct spelling in your conversations. Not all state laws have the same terms and definitions which often adds to the confusion when referring to; metabolic disorders, metabolic formulas, and most of all the specialty low protein foods for health insurance providers. The table below provides a comparison of the terminology used in a sample of 7 different state laws; Connecticut (CT)(5), Massachusetts (MA)(3), Maine (ME)(6), New Hampshire (NH)(7), New Jersey (NJ)(8), New York (NY)(9),  and Vermont (VT)(10).

As long as your health insurance policy is not an ERISA exempt or self-funded or self-insured plan, then existing state law mandates should be applicable to your request for coverage as specified by your state law. Utilizing your state law’s terminology should greatly help to reduce confusion on the part of your health insurance reviewers.

If your state does not have a state law and/or your health insurance policy is an ERISA exempt plan, then continue to be consistent, politely persistent, and most of all patient, remembering that medical necessity is still on your side. Ask for a nurse case manager, and always note the names and phone numbers (extensions) of helpful and sympathetic contacts. Utilize your metabolic clinic’s terminology whenever communicating with your health insurance customer service representatives.  Ask your clinic for a copy of the medical necessity prior authorization request letter so that you can emphasize from your personal perspective the medical benefits and necessity to obtaining health insurance coverage. Discuss and educate your health insurance about the risk of OA metabolic instability resulting in the potential for more frequent inpatient hospital admissions for acute medical management. Clarify the potential short and long term OA medical consequences to you/your child without the ongoing provision of medically necessary OA disorder specific treatments. Reference the updated May 2003 American Academy of Pediatrics policy statement that ‘supports reimbursement for foods for special dietary use for inherited metabolic diseases and also calls for legislation to mandate consistent coverage for foods.(11)

How? The Bottom Line…

In some cases, problems obtaining monthly refills of metabolic formulas, medical supplies, OA disorder specific medications, and low protein foods are not because of health insurance denials for approval, but because of difficulties with finding a contracted provider with your health insurance policy. Health insurance contracted providers typically include Pharmacies, Durable home durable medical equipment supply companies (DME), Home health infusion companies (HHI), and Low protein food companies (but not all low protein food companies offer health insurance billing programs). Which company provides your monthly refills depends upon the specifications of your health insurance policy.  Your metabolic clinic or primary care provider would need to refer you to an approved contracted provider and write your OA disorder specific prescriptions and medical necessity letters. With a current health insurance prior authorization for approval of coverage, then your contracted provider(s) may start to provide you with monthly refills while submitting the bills on your behalf to your health insurance for reimbursement.

Some contracted providers have limitations determined by their company policies. Some contracted providers are not able to provide all brands of specific metabolic medical foods. Some companies are not able to assist patients who take their metabolic medical foods by mouth and will only provide refills to enteral tube fed patients, while other companies will provide monthly refills to both oral and tube fed patients.  Most contracted providers are not able to provide monthly refills of specialty low protein foods.

​Difficulties for DME/HHI/Pharmacies working with health insurance providers most often seem to be caused by problems with current medical billing systems and therefore the bottom line….adequate reimbursement rates equal to the actual cost of the products.  Current medical billing systems include national Medicare, state Medicaid, and private payer (e.g., BCBS of MA, Tufts Health plan, Cigna, etc) medical billing codes. Formula companies submit their OA disorder specific medical foods to the US FDA for review to be assigned specific billing codes. But not all metabolic disorder specific medical foods are assigned billing codes that are recognized by all health insurers, and some codes are not defined to allow for adequate reimbursement rates to reflect the higher cost of developing and manufacturing metabolic disorder specific medical foods. Metabolic medical foods are much more expensive for formula companies to manufacture and develop compared with non-metabolic disorder specific infant, pediatric, or adult formulas. Metabolic disorder specific medical food codes should reflect this cost differential, but do not always seem to do so.

These challenges seem overwhelming. So what can parents and people living with OA metabolic disorders do to try to help clear up all this confusion?

OA ‘To Do List’

  1. Raising Awareness. Continue your efforts to raise awareness and educate others about OA disorders and medically necessary OA disorder specific medical-nutritional treatments.  Try to gain advocates in all your communications with; your health insurance customer service staff, your health insurance case managers, and your pharmacy and/or DME/HHI companies.
  2. Consistent Terminology. At all levels of the process, from the metabolic clinic’s prescription and medical necessity letter to your communication with your health insurance and contracted providers. This should help to avoid miscommunication and prove the medical necessity of OA specific medical and nutritional therapies.
  3. Organize Your Information. Obtaining and maintaining consistent health insurance approvals of coverage of medically necessary metabolic disorder specific prescriptions is like doing your income taxes.  Gather contacts and work with your clinic by keeping track of deadlines for renewals of health insurance authorizations.
  4. Utilize Resources. Every state has a division of insurance to assist health insurance consumers with concerns. In MA, the Office of Patient Protection provides all MA state residents health insurance information.
  5. Plan Ahead. Allow for plenty of processing time, your health insurance prior approval process may take from 7 business days up to 30 days or more depending upon your health insurance policy, additional time is necessary for appeals of denials. Allow for additional time for your metabolic clinic and/or primary care providers to write medical necessity letters specific to your individual medical needs and communicate with your health insurance and contracted providers. Whenever possible, provide advance notice to your metabolic clinic and/or primary care providers with any health insurance changes and/or approval renewals requests. In our clinic, we typically ask for 4-6 weeks notice.
  6. Shop Around, Ask Questions, Read the Fine Print. If you are given an annual choice of health insurance plans, ask in advance about benefits and coverage for your OA disorder specific medical needs.  Remember to always check if your primary care provider, metabolic clinic and other specialty physicians are approved providers of any new health insurance plan. 
  7. Legislation and Advocacy. Contact and provide feedback to your state representatives if your state law isn’t working for you, or if you think a state law would be helpful to your situation. We also need universally recognized and accepted medical billing codes for our metabolic disorder specific medical foods, medications, and low protein foods that are not limited by age, feeding route (oral or enteral tube), or form that also allow for appropriate reimbursement rates.  


  1. OAA Newsletter, Vol 13 (1)  Jan 2003, p. 15-19 Practical Nutritional Considerations for Organic Acidemias
  2. Website: National PKU News: State laws and policies complied by Virginia (PKU Legislation and policies) or contact your state’s bill library.
  3. MA state law: M.G.L. Chapter 32A, Section 17 (effective 1/4/94)
  4. Website: U.S. Food and Drug Adminstration Center for Food Safety and Applied  Office of Special Nutritionals, May 1997. Search website for ‘medical foods’
  5. CT state law: Committee bill No. 524, LCO No. 4671, Section 38a-492c, effective 10/1/2001
  6. ME state law:  Chapter 33, Section 2745-D, effective 1/1/1996
  7. NH state law: Chapter 415 Section 415:6-c, effective 7/20/1996
  8. NJ state law: P.L. 1997, c. 338, (SB 1887) effective 1997.
  9. NY state law: Chapter 177 (assembly bill 352B) Section 3216, 3221, 4303 effective 1997
  10. VT state law: No. 128 (S.253), Sec. 1.8 V.S.A. SS 4089d (eff. 10/1/98) 
  11. Pediatrics, Vol 111(5): May 2003, p. 1117-119
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