An Open Letter to Health and Human Services

On Monday, December 10, 2012, the following letter was submitted to the U.S. Department of Health and Human Services via, an openly accessible website that enables the public to weigh-in on the federal decision-making process. This particular letter was submitted in response to the “Patient Protection and Affordable Care Act: Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation” rule, which would leave the decision to each state to select its own essential health benefits. If this rule were to pass, then states may or may not include coverage for medical foods to treat patients with Phenylketonuria – or PKU.

Patient Protection and Affordable Care Act, PKU, Phenylketonuria, is the government site that allows citizens to submit comments on proposed regulations and related documents published by the U.S. Federal government.

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-9980-P
P.O. Box 8010
Baltimore, MD 21244-8010

Dear Health and Human Services:

As I sit here drafting this very response to proposed rule CMS-2012-0142, the State of Tennessee where I reside is all a buzz with the news that Governor Bill Haslam has announced his decision that Tennessee will not run its own health-care exchange. The decision means that under the Affordable Care Act, the federal government would create online market exchanges where consumers could purchase individual private health-insurance coverage plans. Evidently, more than 20 states have announced similar decisions in advance of the December 14 deadline imposed by the White House. Nonetheless, it is still imperative that the those within your organization ensure that every state across the nation offer health benefit plans that provide coverage for medical foods for the treatment of Phenylketonuria (PKU) under the chronic disease management category.

Representatives from the National PKU Alliance recently met with HHS on this issue and reiterated the notion that PKU is a rare genetic disorder that requires lifelong treatment to avoid brain damage, which can cause severe mental retardation and other neurological complications. In response, you requested that I and others in the PKU community submit comments and concerns regarding the proposed new regulations no later than Dec. 26. This letter contains my thoughts and I will be posting this letter to my PKU Parlor blog in the hopes that others will also submit comments.

So that you are reminded that your decisions will impact real people, here is a brief background on me and my experience living with PKU:

Thanks to newborn screening, I was diagnosed with PKU at birth and immediately placed on a low-protein diet. For me, this meant not eating any meat, dairy products, NutraSweet or any other combination of foods that were known to be high in protein. I was required to drink medical formula each day to help supplement the nutrients I was missing as a result of the restricted diet. Growing up in a suburb just outside of Pittsburgh, Pa., I was fortunate to have my medical formula covered by the state health department and managed to maintain the low-protein diet for much of my early childhood.

I was allowed to go off-diet at a young age, back at a time when doctors within the field thought that such discontinuance was a good idea. Nowadays, after decades of proven evidence-based success in treating PKU patients with medical foods, the medical community realizes that failing to ensure coverage for PKU is catastrophic and will lead to mentally damaged babies and PKU adults living with severe disability. I was able to live for many years without being on the restricted diet, but it is important to note that there are many variations of severity in PKU as there are with diabetes. I am what you might say is a high-functioning off-diet PKU patient…but not the norm.

Despite my ability to succeed off-diet, I have recently faced challenges when trying to return to the low-protein diet. That is because as a young woman, recently married and ready to start a family, I have had to come face-to-face with the realization that before I can even conceive, I must drastically lower my protein levels and prove I can maintain those levels throughout the duration of a pregnancy. This situation, often referred to as maternal PKU, has varying levels of success depending on the mother-to-be’s access to medical care, formula and low-protein food products. It is also worth noting that in the process of re-acquainting myself with the low-protein diet, I quickly learned that without insurance, it would cost an average $800/month just to drink the formula. The State of Tennessee does not cover the cost of PKU formula, which when compared to my birth state, provides just one example of the great disparities already existing among our 50 states. Obviously, purchasing low-protein foods such as low-protein pasta, imitation meat and non-dairy cheese would cost even more.

In short, providing this coverage nationwide will ensure that PKU patients adhere to the diet and continue to serve as productive members of society. Without insurance coverage, the cost of formula and food is comparable to what many middle-class families pay for rent or mortgage. Failing to ensure coverage for medical foods would discriminate against people with PKU based on their disability, which is expressly prohibited by the Affordable Care Act. And to draw upon a diabetic metaphor one last time, medical foods are as important to a person with PKU as insulin is to a person with diabetes.

Thank you for your time,

Nicole Merrifield


Filed under Advocacy

2 responses to “An Open Letter to Health and Human Services

  1. Pingback: Billing PKU Formula According To Calories | PKU Parlor

  2. Pingback: PKU Letter Campaign to HHS Makes an Impact! | PKU Parlor

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