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:

Lack of knowledge/awareness about rare metabolic disorders and the medical necessity for uncommon and therefore expensive medical-nutritional treatments
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).

General term	State law terminology	State

OA disorders	‘Inherited metabolic disease’	CT, NJ, VT
OA disorders	‘Inherited diseases of amino acids and organic acids’	MA, NH, NY
OA disorders	‘Inborn errors of metabolism’	ME
Metabolic formula	‘medical food’	NJ, VT
Metabolic formula	‘enteral formula’	MA, NH, NY
Metabolic formula	‘metabolic formula’	ME
Metabolic formula	‘amino acid modified preparation specialized formula’	CT
Low protein foods	‘low protein modified food product’	CT, NJ, VT
Low protein foods	‘food products modified to be low protein’	MA, NH
Low protein foods	‘modified solid food products that are low protein’	NY
Low protein foods	‘special modified low protein food products’	ME

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 (extentions) 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’

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.
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.
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.
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.
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.
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.
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.

References

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