In a previous post, I posted the comment I submitted that is due on December 26. This post provides a fuller explanation of the proposed regulation and the reasons for my comment. I invite you to submit your own comment on the proposed regulation. Read on to find out why.
With the election over, the Department for Health and Human Services (HHS) has issued regulations to fully implement the Patient Protection and Affordable Care Act (PPACA), aka “Obamacare.” The comment period for one of the HHS regulations closes on Boxing Day, December 26, and provides one more chance at improving the administration of prenatal testing for Down syndrome and other genetic conditions.
PPACA lists certain services as being “essential health benefits” or “EHBs.” Among those listed are laboratory services, hospitalization, prescription drugs, and maternity care services. The latter, maternity care services, are cited as an example of how Obamacare will fundamentally transform health care. Currently, insurance policies often do not cover maternity care as part of their default plan offerings. With PPACA listing them as an EHB, the proposed HHS regulation will require state “benchmarking” plans to provide for maternity care services.
Current state-approved policies that include maternity care services typically base coverage on medical organization guidelines. For example, Blue Cross/Blue Shield of Tennessee adopted as its clinical practice guidelines the American Academy of Pediatrics (AAP) and the American Congress of Obstetrician and Gynecologists (ACOG) Guidelines for Perinatal Care, as well as the ICSI Guidelines for Routine Perinatal Care. “Routine” care includes testing for Down syndrome and other forms of aneuploidy.
The dissent in the Institute of Medicine (IOM) report on preventative care services for women noted that professional guidelines are not adopted as recommendations for what should be covered in insurance policies. But, PPACA is transforming professional guidelines into fulfilling that function. The comment period is one of the last opportunities to ask some critical questions that should be answered before committing the weight of federal health insurance policy to backing prenatal testing for Down syndrome as an essential health benefit:
Question 1: Why is prenatal testing for Down syndrome required as an “essential health benefit”?
While fundamental, shouldn’t this question be answered first? There has been no evidence to show that prenatal testing for Down syndrome actually improves health outcomes. For every study that reports anecdotally how expectant mothers value prenatal testing so that they can prepare for the birth of their child, there is an off-setting study that finds increased anxiety, coercion and pressure from partners, loved ones, and medical professionals. Most recently, a study found that the knowledge imparted by prenatal genetic testing can be toxic for its negative effects on the mother’s well-being.
Note, however, that even these studies center around the mental state of the mother, not a medical finding that prenatal testing actually results in an improved health outcome for the tested pregnancy. Therefore, before requiring that prenatal testing for Down syndrome be covered by insurance as an “essential health benefit,” shouldn’t prenatal genetic testing first be shown to result in improved health outcomes? Particularly when its costs are considered, which leads to question 2.
Question 2: Has a cost-benefit analysis been conducted to justify the cost of prenatal testing for Down syndrome?
There are approximately six million pregnancies each year in the United States. The average cost to receive a prenatal diagnosis for Down syndrome is at least around $1,000, and much more if prenatal screening tests precede diagnostic testing. These numbers present a potential $6 billion liability to the annual cost of health care, should every pregnant woman accept the “essential health benefit” of prenatal genetic testing. Given that no medical benefit has yet to be shown from prenatal genetic testing for Down syndrome, by definition then, there is another procedure that would be a better investment of scarce health care dollars to result in improved health. It would be of interest, then, to know whether HHS has conducted a cost-benefit analysis, and, if so, how costs and benefits were determined. Of particular interest would be what was included in the costs, which leads to question 3.
Question 3: Will the HHS regulations for maternity care services require coverage for all recommended services involved with prenatal testing for Down syndrome?
In 2008, a health care reform law was passed by unanimous voice vote in both houses of Congress and signed into law: the Prenatally and Postnatally Diagnosed Conditions Act. The Act recognized that the current administration of prenatal testing was deficient: patients were receiving inaccurate, out-dated information; were not being referred to parent support groups; and, were not advised of the option of adoption following a diagnosis. The Act called for the HHS to address these deficiencies. Yet, since its passage, despite HHS granting millions of dollars to develop next generation prenatal testing for Down syndrome, the Act has not received any appropriations or similar agency funding.
Insurance policies that do cover prenatal testing also often do not cover the associated services recommended by the medical guidelines for prenatal testing. Medical professionals are to be well-informed about the testing and the tested-for conditions, but they are not; patients are to be referred for genetic counseling prior to diagnostic testing, but they are not, or if they are, often the counseling is not covered; and, patients are to receive accurate information and referral to parent support organizations following a diagnosis, but they do not and are not.
If the vast sums of scarce health care dollars are to be spent on a procedure that has not been shown to improve health on the basis of following medical guidelines, then the HHS regulations on EHBs should require maternity care services to provide coverage for all recommended services for prenatal testing for Down syndrome—medical education, genetic counseling, accurate written materials, and patient support—not just the testing by itself.
Conclusion
The HHS EHB regulations provide another chance to finally implement the purposes of the Kennedy-Brownback Act and improve the ethical administration of prenatal testing. Skeptics and critics of this commentary will think its purpose is to deny women prenatal testing for Down syndrome. This is not the issue. Prenatal testing will continue to advance and be available, and, under PPACA’s preventive care regulations, it will be required to be provided at no cost. But, before it also is required to be covered as an “essential health benefit” shouldn’t it be demonstrated that prenatal testing for Down syndrome qualifies for those words, i.e. that prenatal testing for Down syndrome is shown to benefit health and is essential? That is the statutory rubric by which the HHS regulations are attempting to mandate its coverage, but if prenatal testing does not meet that criteria, then covering prenatal testing necessarily takes funds away from a service that is an essential health benefit. And, if it is to be covered, shouldn’t all of the other recommended services associated with prenatal testing also be covered?
These questions and concerns will only be addressed if there are enough comments submitted. Again, comments are due by December 26, 2012. Comments can be submitted at this link. The comment I submitted is available here and is written to meet the character-limit for comments; feel free to cut-and-paste and use for your own comment or revise as you see fit.
Your blog argument against Down Syndrome testing as an EHB (12/19) comes off as someone with an ulterior motive trying to reverse-engineer the proposed policy for the sole purpose of preventing it. It just seems dishonest. I haven’t read anything else you’ve written, nor have I ever heard of you before so I don’t know if you are a Pro-Life (or pro-down’s) zealot who is afraid that DS testing will result in more DS babies being aborted; and this is something you are uncomfortable with.
Regardless, speaking about patient outcomes (in terms of the mother) and whether or not there is justification for DS is pointless, we all know what DS testing is for. It is so that individuals who are not prepared to be a slave (emotionally, physically, and financially) to a special needs child for the rest of their time on this earth, can receive early notification while the option to terminate is still available. Plain and simple.
Just because you have a DS child (and you can characterize the affliction as an endowment if you like, but you are only lying to yourself and the choir of pro-life/pro-down’s), does not mean that others should be forced to suffer as you do. I am sure that you are blind to your own suffering as well. Blind to the realization that Down’s is the “gift that keeps on giving”; 24 x 7 x 365, until you draw that last breath wondering who will take care of your “gift” when you are gone (unless, as frequently happens, your “gift” succumbs to multiple chronic medical problems and exits before you!, what a wonderful thing to have to hope for, eh?).
In any event, good luck with your pointless rant. it falls upon deaf ears.
Michael Callahan: I have been a “slave” for 45 years, and it has been the most delightful servitude imaginable. DS is not contagious, but your kind of ignorance might be, so I’m hoping that I am the only person unfortunate enough to have read it!
Soo…Janice– Michael Callahan is a total dick. Agreed?
Dr Jerome Lejeune is the French scientist who discovered trisomy 21, the cause of Down syndrome called it an illness, and sought to cure it using the best science had to offer. Today we see his legacy living on in the Jerome Lejeune Foundation. Dr Lejeune acknowledged the suffering endured by both patients with T21 and their families, however, he was horrified when his discovery in 1959, for which he received the Kennedy Prize 50 years ago, led to eugenic abortion. The great majority of those with Down syndrome are aborted for such noble sounding reasons as you have stated.
When you target one specific population for death at any age or medical condition, your compassion turns ugly. No one can determine whether another human being’s life is worth living. Not without following in the lethal legacy of the death camps.
Despite significant developmental delays, an abnormality in her spine, and possible autism, my ten year old daughter Christina is a joyful young lady who lives life with gusto. I, her mother have diabetes, and chronic back pain. We love our life together with my other two daughters and my husband. We don’t want your misguided compassion to end our lives, and neither do the thousands of unborn babies who are killed by this excuse for compassion. True compassion works to help us find treatments to alleviate the symptoms of Down syndrome, and improve the learning and memory of our children, and help those who cannot afford medical care and therapy provide it for our children. False compassion seeks to eliminate the child.
Dr Lejeune fought this mentality till his untimely death in 1994. He said,
“People say, ‘The price of genetic diseases is high. If these individuals could be eliminated early on, the savings would be enormous!’ It cannot be denied that the price of these diseases is high—in suffering for the individual and in burdens for society. No to mention what parents suffer! But we can assign a value to that price: it is precisely what society must pay to be fully human.”
Thankfully not everyone shares your unique perspectives on the Downs’ Syndrome condition. Life is a gift.
The only deaf ears here are yours, apparently. It doesn’t take a “zealot” to realize that without an absolute right to life, there are no rights whatsoever. Some of us are pro-life from womb to tomb and not because we’re “zealots”, but because we see the truth that every life has inherent value and that there is no “slavery” in parenthood. The only slaves are the ideologues who refuse to see the humanity and inherent value in every person conceived on this planet.
Thanks to all the comments. Regarding Michael’s initiating comment, I will forgo responding to its nastiness, but do have this response to Michael:
The subtitle of this blog is a resource for information-seekers, which is what most women who accept prenatal testing are: individuals seeking information about their pregnancies. Your central point is that prenatal testing for Down syndrome is to allow mothers to avoid the suffering caused by having a child with Down syndrome. I would like to know the basis for those two points.
What is your basis for saying “everyone knows” that prenatal testing is to allow for the abortion of fetuses with Down syndrome? I would welcome citations to public statements by test manufacturers, professional medical organizations, journal articles, or other publications that support your statement.
I also would like to see any similar publications from the last 20 years that document the suffering caused by Down syndrome. In a later post, I will share those studies I am aware of that report findings consistent with what Andrew Solomon found after interviewing many parents for his book which I reviewed in a previous post, namely that while raising a child with Down syndrome comes with challenges, parents overwhelmingly love their children with Down syndrome, are proud of them, and consider themselves better people because of the experiences they have had raising a child with Down syndrome.
Again, I’m asking for evidence through publications that document statements on the purpose of prenatal testing and the actual experience of raising a child with Down syndrome that provided the basis for your statements.
I have had trouble with Mr. Callahan’s response for several reasons, but the most prominent one is that he’s right. You will be a slave to your child emotionally, physically and financially until you or they die. But not because of Down Syndrome. I don’t know a decent parent alive that isn’t an emotional slave to their child, that doesn’t stay up worrying about their happiness, safety and well being. Nor do I know a parent that doesn’t physically care for their child and pay for the needs of a typical child such as medical needs, sports, hobbies, various interests that a child with or without a special need will have. In addition to those things, what I have witnessed because of my work with those who suffer with substance abuse issues, are many parents of typical children having to pay the bill (emotionally and financially) for rehab and bail money. I’ve watched my own parents worry about me as my job closed down and they have helped me financially. In there 60’s I have watched them help me move 3 times. If this enslavement is what prenatal testing is meant to prevent then perhaps the only prenatal test needed is a pregnancy test because obviously it is the major tenet of parenthood. If we all look at our own families we can see examples of older parents worrying, caring, and giving financially in some way to help their adult children. The reason Down syndrome is an endowment instead of an affliction is because of the amazing return you receive on the emotional investment. I am not pro-life zealot, and quite frankly I am not sure what “pro-down’s” means. It just seems illogical to me that only parents of children with special needs are somehow burdened with what I’m pretty sure is just parenthood.