Tag Archives: Patient Protection and Affordable Care Act

PKU Letter Campaign to HHS Makes an Impact!

There’s some good news to report in the PKU community: the Health and Human Services letter writing campaign–initiated by the National PKU Alliance aimed at ensuring that every state’s essential health benefits plan provides coverage for medical foods–has made a difference. This article, originally published in Congressional Quarterly’s Healthbeat News on Dec. 21, 2012, provides more details about how those comments have been received.

 Patients Bombard HHS With Pleas on Essential Benefits Packages
By Jane Norman, CQ HealthBeat Associate Editor

Congressional Quarterly HealthBeatParents of children with rare diseases, advocates of acupuncture and other individuals are beginning to flood the Department of Health and Human Services with pleas and complaints about which specific services should be included in states’ essential health benefits packages.

Public comments on a proposed rule on essential health benefits aren’t due until Dec. 26, but more than 1,000 responses already have been received, according to the government website where the reactions are posted. Nearly all the comments so far are from individuals rather than organized groups or health business interests, though those groups also are starting to weigh in.

The letters from worried patients, doctors and family members across the country are an indication of the intense interest not just within the health industry but also among members of the general public – many with diseases or chronic conditions – in the outcome of decisions on benefit packages, which will vary from state to state and have a major impact on some people’s lives.

More than 11,000 comments had been filed in response to a bulletin issued on benefits before the rule was unveiled a month ago.

Some writing in are also asking for more time for comments to be gathered, saying that 30 days stretching over the holiday season isn’t enough time for people to digest a 119-page proposed rule and offer input on what should be changed. “Thirty days during the holiday is poor timing,” said an anonymous comment that suggested 90 days instead.

On Nov. 20, the Centers for Medicare and Medicaid Services released its proposed rule (See related story CQ HealthBeat, Nov. 20, 2012) establishing the essential health benefits required under the health care law (PL 111-148, PL 111-152). Non-grandfathered health plans offered inside and outside exchanges must, under the law, include benefits in 10 broad categories of services. State officials are supposed to pick a benchmark plan in their state as a model. HHS included some additional specific details on benefits in its proposed rule, but many commenters want more.

Don Hossler, who didn’t list an address, said in a comment that the federal government should have required that states get public input before naming their benchmark plans, including from groups that advocate for people with disabilities. “I realize there is a short time for a state to conduct meaningful public comment,” he said. “However, grass-roots organizations need to be allowed ‘at the table’ to enhance the decision based on consumer input.”

Dozens of people have written in already asking that coverage of medical foods be included for patients with PKU, a rare, inherited metabolic disorder in which the body can’t process the amino acid phenylalanine. Treatment must be started early in order to avoid damage to the body and involves a special diet, according to the National PKU Alliance.

Aleksandra Pisarek wrote that she is the mother of an 8-year-old boy with PKU who will require lifelong treatment to avoid brain damage. “Failing to ensure coverage for medical foods discriminates against people with PKU based on their disability,” she wrote.

The National PKU Alliance has urged members to write HHS, noting that the decision on medical foods may be left up to each state unless the government requires coverage of medical foods as part of the essential benefits category that covers chronic disease management. “Representatives from the NPKUA recently met with HHS on this issue, and HHS urged us to have as many people as possible submit comments on the new regulations,” the alliance’s website states.

Another group whose members sent many letters to HHS are those who receive or administer acupuncture treatment. Patricia Solomon, a Massachusetts pediatrician, said that “some of my most aware and careful parents seek acupuncture” and other alternative health treatments for their children. She said she was dismayed to see no alternative treatments included in the standards outlined for benefits. “Their value as adjuncts to traditional medicine is becoming clearer,” Solomon said.

Tabitha Silver of New York wrote, “Acupuncture has changed my life. It was the only thing that helped me with depression and pain.”

Stephen Scholle, the clinical director of a nonprofit that serves mental health consumers in Westchester and Rockland counties in New York, said his group provides acupuncture and should be included in essential health benefits, perhaps as part of wellness and preventive care. It helps with stress relief, pain relief and mental well-being, Scholle wrote.

Another commenter, Terri Bukacheski, said she is concerned that rehabilitative services and devices that are required to be provided in one essential benefits category are not well-defined. “Patients that require prosthetic limbs and orthopedic braces require these custom services for a lifetime, and the care must be provided by highly skilled experts,” she wrote. Devices should be clearly defined to include prosthetic and orthotic services, she added.

The time period for submitting comments in response to the “Patient Protection and Affordable Care Act: Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation” rule has passed; however, visit the National PKU Alliance website for more information on how to support future advocacy efforts.




Filed under Advocacy, Formula

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 www.regulations.gov, 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, Regulations.gov

Regulations.gov 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