Billing PKU Formula According To Calories

Here’s something you may not know when it comes to the business of distributing and paying for PKU formula.

After trying the free sample of RESTORE LITE provided to me by Cambrooke Foods, I immediately connected with my clinic to have it added to my formula prescription. Apria Healthcare, which is the medical supply company that processes and ships my formula, called and told me, “We do not carry RESTORE LITE. We carry the regular RESTORE, but not the LITE.” After reporting this news back to my clinic, we decided to try Edgepark, a competitor of Apria Healthcare. What was Edgepark’s response? Not only does Edgepark not carry RESTORE LITE, they cannot carry the LITE because Apria, EdgePark and other “durable medical equipment” companies are reimbursed according to the number of calories in the formula.

PKU formula, Phenylketonuria formula, low-protein diet

The revelation that durable medical equipment companies are reimbursed according to the number of calories in PKU formula provides a whole new meaning to the phrase, “Spend your calories wisely!”

Call me crazy, but billing insurance carriers based on caloric value seems ridiculous, so while my dietician continues to search for an alternative medical supply company from which I can order my preferred formula, I decided to investigate this a little further.

A basic keyword Internet search turned up a 56-page document created by Abbott Nutrition and titled “Medicare Part B Enteral Nutrition Reimbursement Manual, 9th Edition.” Abbott Nutrition, which creates powdered PKU formulas such as Phenex-1 and Phenex-2, created this manual as a way to guide health care suppliers through the process of billing the U.S. federal health insurance program called Medicare. Here’s how the process is explained on page 9 of the manual:

Enteral nutrition formula is billed in “units.” A unit is defined as 100 Calories.

  • Calculation of units: Cal per day ÷ 100 = units per day
  • e.g., 6 cans/day  x 250 Cal/can = 1500 Cal/day ÷ 100 = 15 units/day
  • 15 units per day x 30 days per month = 450 units per month

Sound all Greek to you? Well, it does to me too. It appears that billing formula based on calories is a government-mandated method, but why (if I am not on Medicare) does it apply to me? Do durable medical equipment supply companies decide to apply this method across the board since they are already required to do so for Medicare patients? And what does that mean on a personal level? Do PKU patients now have to decide whether eating healthier is worth what is likely a significant increase in cost?

This way of thinking–whether it originates with the U.S. Government or with the medical supply companies–sounds all too familiar. For years, PKU patients have struggled with medical foods coverage based in large part on the incorrect assumption that a low-protein diet is cosmetic and only for achieving weight-loss.

Despite calorie count, medical formula is medical formula. Period.

If anyone from Cambrooke and/or Abbott Nutrition are reading this blog, I’d love to hear another perspective on this formula conundrum in the comment field below. Hopefully someone can explain why the 100-calorie difference you see between regular RESTORE and RESTORE LITE ultimately determines whether a patient in need receives their medical formula.



Filed under Advocacy, Formula

7 responses to “Billing PKU Formula According To Calories

  1. saranoonan

    Hi Nicole – I’m the product manager at Cambrooke Foods. We are just as frustrated as you are. Because RESTORE and RESTORE Lite are a partial formula, they are given a different B-code than complete formulas, such as BetterMilk. As dictated by CMS, partial formulas are reimbursed by calorie and as a result, some DMEs are unwilling to carry the lower calorie version of RESTORE. We have also run into issues with receiving a reimbursement code for our COMPLETE bars. Again, as dictated by CMS, PKU formulas fall under the enteral category which means they must be a liquid, not a solid, so that they can go down a feeding tube. This is again very frustrating for us because while individuals with PKU do not need to be fed via a feeding tube, they will not change the wording to accommodate alternative protein equivalent formats.

    Have you looked into our Green Light Program to obtain RESTORE Lite yet? I can’t guarantee that this avenue will work as I do not know if your insurance policy requires an in-network provider to distribute your formula, but it may be worth a shot. The application is available online here:

    Another option is to see if Walgreens or CVS will provide RESTORE Lite.

    If you have any questions at all, please feel free to email me at

    Sara Noonan
    Product Manager, Cambrooke Foods, Inc.

  2. Sara,

    Thank you for taking the time to comment. I appreciate the suggestions you provided as alternative ways for getting RESTORE LITE. I believe my dietician is in the process of determining whether Walgreens Infusion out of Nashville will carry the product. I’ll be sure to let her know about the Green Light Program as well.

    As a side note, you are probably already aware of this, but I also saw in the manual mentioned in this blog post that PKU formula is considered a prosthetic. When I think of prosthetics, I think of an artificial device extension used in place of a missing limb…not enteral formula. Perhaps the argument could be made that it is a prosthetic since it aids with a PKU patient’s “malfunctioning” liver, but that in itself seems to be a bit of a stretch.

    Sounds like we’re captive to quite a few inapplicable definitions, huh?


    • saranoonan

      Hi Nicole – Completely agree! It’s very frustrating. Furthermore, it’s incredibly difficult to change this legislation.

      Let me know what I can do for you in regards to RESTORE Lite.


  3. Sarah Gallagher

    Thanks for this post, I had no idea! Very informative (and frustrating). Good luck!

  4. Pingback: Is taking-on maternal PKU a rational decision? | PKU Parlor

  5. Pingback: Calories – Why you’re not just counting phe during maternal PKU | PKU Parlor

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