Jennifer Payne_The Patient Voice est.1973

Passionate*Potential*Policy Driven: PKU

Expert Testimonials

NABSP Board of Directors 1977 recommended: "amino acid based foods be considered an exception under the prescription drug program, as is the case with insulin."

- Lance O. Hoxie, Assistant Director Professional Relations,

National Association of Blue Shield Plans

"Although new products continue to be developed, the reclassification has left a trail of policy changes by insurance companies, such as yours, refusing coverage for a food."

- Walter Sondheim, Jr., 1979

Chairman, Maryland Commission on Hereditary Disorders

According to the US Office of Personnel Management, Chief, Federal Employee Insurance Operations, Nov 13, 2015 letter enclosure to US Senator Ben Cardin:

"Ms. Payne enrolled in BCBS for the 2015 plan year with the expectation of coverage for Glytactin Bettermilk based on the verbal information she was provided. Ms. Payne was not notified when this product was reclassified as an OTC product and the prescription should not have been covered as Ms. Payne is an adult." - Sylvia Pulley, RN

Historical Timeline of Events on the Evolution of Medical Foods Policy under the Federal Plans

1934 (Norway) Thanks to the tireless, persistent efforts of one mother seeking a diagnosis for her two children, the discovery of phenylketonuria (PKU) was made by Dr. Asbjorn Folling and marked a major medical breakthrough in the history of biochemical genetics.

1951 (England) As a result of the tireless, persistent efforts of another mother - seeking treatment for her PKU daughter, - the invention of the first PKU formula (Dr. Horst Bickel and colleagues, Evelyn Hickmans, John Gerrard, with theory proposed by Dr. Louis Woolf) was introduced. It was later scientifically proven that initiation with PKU formula early in life could prevent mental retardation. 

1958 PKU treatment extended across the Atlantic to the United States. The doors of the commercial market opened with the launch of the prescription drug, Lofenalac (Mead Johnson) FDA approved on January 15, 1958 for patients with phenylketonuria.

1972 Under the Drug Efficacy Study Implementation (DESI), the National Academy of Sciences - National Research Council (NAS-NRC) report was implemented in an unusual manner, for the FDA reclassified Lofenalac the prescription drug to a “nonprescription special dietary food.” This landmark decision has forever tested the definition of what is known today as “medical food.”

1978 Congress signaled Commissioner Kennedy of the United States Food and Drug Administration to review, comment and report on Lofenalac (Mead Johnson) on behalf of the constituent, Mrs. Carole Weiland, mother of two PKU children. 

1979 Special recognition was given to Mrs. Carole Weiland from Chairman Sondheim, Jr. (MD Commission for Hereditary Disorders) for convincing the Federal Employee Government-Wide Plans to provide coverage for Lofenalac and other amino acid bases for her children and other families covered by these plans. 

The Lead of the Federal Plans:

1979 A press release was issued to all families in the Maryland program covered by the Government-Wide Plans.

1980 Principal contract changes for all the Federal Plans are introduced and include provision of benefits for amino acid modified formulas and medical foods for inborn errors of amino acid metabolism for the contract period beginning January 1, 1980. 

These historic changes which allowed for access to PKU treatment and secured lifesaving, medically necessary treatment of patients with inborn errors of amino acid metabolism at the Federal level were largely due to the persistent, tireless, advocacy efforts of a true PKU pioneer, my mother. 

Unfortunately, federal policy has not kept pace with the science of the times and the children once covered under The Plan are grown adults now. 

2015: In the height of National PKU Awareness month (May observance), I experienced a sudden and unjust reversal in coverage for PKU treatment with medical foods under BlueCross BlueShield carrier to the Federal Plan. The consequences for lack of a knowledge-based decision, discriminatory provision of treatment, care and services, unethical federal operations, and poor Congressional oversight on contracted agreements with the US Office of Personnel management and BlueCross BlueShield resulted in a repeated pattern and history of adverse events which necessitated firm, legal forces to reverse this most historic wrong.

Following the lead of my parents, I fought the feds. On December 3, National PKU Awareness Day, it became official - I won retroactive coverage with an allotment of a 6 month supply of medical food as an eligible, reimbursed pharmacy benefit under the FEP. 

2016: Despite the success of reminding insurers of their obligations to reimburse as per contracted benefits plan agreement, the approval expired as of January 1, 2016. Policy exclusion criteria continue to prohibit access with denials in future coverage of PKU treatment because of my age and First Data Bank reclassification of medical foods from Rx to OTC. As a federal employee living with PKU and dependent upon medical foods for health and survival, I have no other options for coverage on justified, costly treatment.

I am still in the fight to bridge this gap. I seek justice and provision of safe, quality, affordable, equitable access to medical foods, the cornerstone of PKU treatment and lifeblood for patients with inborn errors, saving lives for well over 60 years – and dietary therapy is here to stay!