Tag Archives: GINA

Is GINA Unjust?

The Genetic Information Non-Discrimination Act (GINA) of 2008 is widely regarded by the the genetics community as a critical piece of legislation. GINA provides safeguards against using genetic information to discriminate against healthy people when they apply for health insurance and employment. In what seems like a legislative fantasy from the perspective of today’s polarized American political climate, GINA passed by a vote 95-0 in the Senate, 414-1 in the House of Representatives (Ron Paul of Texas being the lone dissenter), and signed into law by President George W. Bush. It doesn’t get any more bipartisan than that.

I don’t know if anyone has ever studied the impact of GINA on utilization of genetic counseling and testing but my clinical experience, and I suspect that of many of my colleagues, is that discussion of GINA is a component of many genetic counseling sessions. The protections of GINA play a key role in the decision of many of my healthy patients to decide to undergo genetic testing (although Americans have divergent views about health insurance, they have broad feelings of mistrust of health insurers). I am pretty sure that support of GINA among genetics community is as unanimous as it was among the 2008 Congress. Unanimous, that is, except for me. Well, kind of.

Now hear me out before you consign me to Tweet Hell (which, if Dante were to write the Inferno today, he would include it as a 10th circle of Hell, below the 9th Circle of Treachery’s frozen lake where Judas Iscariot resides for sub-zero eternity). I have not sold our genetic savior for a sack of silver and I am not opposed to protecting people from discrimination in insurance and employment. With the future of health insurance in America in question, the prospect that GINA or the Afforable Care Act might one day be repealed gives me a serious case of the fantods. My criticism is that GINA is unfair to people who might suffer discrimination in health insurance for non-genetic reasons.

 

GINA is an example of genetic exceptionalism, the term coined in 1997  by the widely respected bioethicist Thomas Murray to describe the belief that “genetic information is sufficiently different from other kinds of health-related information that it deserves special protection or other exceptional measures.” Genetic exceptionalism has implications for other aspects of genetic medicine in addition to health insurance protection, as my DNA Exchange colleague Allie Janson-Hazell discussed some 8 years ago. Genetic exceptionalism has generated a quarter century of unresolved debate, with supporters waving it as a banner and critics using it as sword to attack the other side. Like Murray, I am critiquing GINA from the perspective of distributive justice – the just distribution of goods and resources.

The starting point of my argument is that, in the absence of compelling reasons otherwise, everyone should have equal access to affordable health insurance. From that perspective, GINA gives the appearance of being a good thing because it helps produce a more equitable distribution of medical insurance among healthy people who have a family history of a genetic condition or who carry a pathogenic mutation. But this is where genetic exceptionalism rears its head. What is it about genetic information that is so special that it requires its own piece of protective federal legislation? There are many other bits of health information of equal or greater import in predicting future health. My own hemoglobin A1C and fasting glucose levels for one, which are in the “prediabetic range” (though I could be “cured” simply by moving north a hundred miles to Canada, where the cut-off for an elevated A1C is higher than in the US). A perverse effect of GINA is that – should the Affordable Care Act be repealed – my A1C levels could be used against me in applying for health insurance but I would be protected from that same discrimination by GINA if a polygenic risk score, a more uncertain predictor of diabetes than A1C or fasting glucose levels, indicated I had an increased chance of developing Type 2 diabetes.The same could be said for lipid levels, blood pressure, Protein C levels, HPV status, and any of a number of other data points that are uncovered when doctors start probing around in the fluids and bodies of healthy patients.

The net effect of GINA when it passed, and could happen again if the Affordable Care Act is repealed, is an unfair distribution of health insurance such that healthy people who have non-genetic risk factors are not afforded equal protection. And, to pack the wound with some salt, this “non-genetic” risk pool could wind up paying higher insurance premiums that result from greater costs incurred by insurers for covering protected people with genetic risk factors who eventually develop breast cancer as the result of a BRCA pathogenic variant or Huntington disease due to an HTT pathogenic variant.

So GINA falls short in the bigger picture of distributive justice. By privileging genetic information, arguing that it is somehow more important than other medical information, GINA results in economic and health care inequities. The unintended implicit territorial message of  the genetics community’s praise of GINA is “Hey man, our patients are protected and that makes GINA a good thing.” But the good that GINA achieves can lead us to ignore its downsides. As I have argued before, our sense of Do-Goodism can create significant blind spots. It is difficult to defend a law as being just if it privileges one group of people at the cost of harming or excluding another group of people for what appear to be arbitrary reasons. GINA is a symptom of America’s ailing health system, not a cure.


Thanks again to Emily Singh for her graphics work.

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Supporting Our Patients and Their Right to Choose Means Opposing Graham-Cassidy

If you are a genetic counselor supporting the Graham-Cassidy proposal to replace Obamacare, you are a rare bird. Most genetic counselors – most medical professionals – most Americans for that matter – are opposed to this bill, because it compromises our ability to provide basic, essential medical care for people in need. It is not in dispute that millions of American will lose health insurance under this bill. Those with health insurance will generally pay more for less. Many of the changes remove existing protections on which our patients are particularly reliant. Here are some examples:

 

PRE-EXISTING CONDITIONS

The bill will allow states to eliminate regulations on pre-existing conditions, so that people will risk losing coverage if they change or lose their jobs. This is a disaster for individuals with chronic health problems including genetic conditions, and potentially a disaster for individuals who carry susceptibility genes. Although you might make the case that GINA should protect those individuals in theory, in practice it becomes hard to draw the line for what constitutes an existing disease in an at-risk individual. For instance, if a Lynch Syndrome carrier requires special screening and has polyps removed, are they preventing disease or symptomatic? Will a subsequent carrier argue that they already showed signs of Lynch and therefore are not covered for further screening or colon cancer? The fact is that Obamacare arrived before these questions got answered, and there is a very real risk that GINA protections will be eroded when the actual lines between pre-existing and manifest disease are drawn.

 

PRENATAL CARE

The new law allows policies to limit or even eliminate coverage for prenatal care. This logic of this abomination – the disgusting and perverse logic to be voted on by a collection of doddering old men who apparently were not of women born – is that pregnancy is not a disease but a choice, and affects only subset of women, so that others should not be asked to bear the costs. This decision abrogates the most fundamental obligation of civil society, which is to raise the next generation. You have one job, civilization. One job.

 

Every politician who argues that it is not fair to ask everyone to pay for insurance that covers prenatal care should be asked if they believe it is fair to ask women to pay for policies that cover prostate cancer care. Or who it is they believe will care for them in the nursing home, or fight for them in their wars, or protect their streets or teach their grandchildren or write their history books if not the next generation of Americans.

 

But you see here I am getting worked up, and the very righteousness of this anger masks another aspect of this change that has particular resonance for genetic counselors: limiting access to prenatal care limits access to prenatal testing, and limiting access to prenatal testing to those with more money will mean that those genetic diseases and conditions for which we can test will change the essential nature of genetic disease – no longer something that happens to everyone, it will become an affliction of vulnerable individuals. I wrote about this in a recent essay, calling it the Ghettoization of Genetic Disease, and this bill will help make that dystopian prediction a reality in the near term.

 

LIFETIME CAPS AND DISABILITY CARE

The Graham-Cassidy bill eliminates protections on lifetime caps, meaning that many individuals with chronic conditions, including genetic diseases, may end up without coverage. In addition, the cuts to Medicaid and other federally funded programs would radically reduce support for individuals with disabilities.

 

On the surface, flat out, this is heinous and cruel. Beyond that, for the genetics community, this undercuts the promise we make, by implication, to every woman or couple who decides to move forward with a pregnancy affected by or at risk for genetic disease. Supporting choice in reproductive decision-making is not a simple matter of holding someone’s hand through a difficult day. Supporting autonomous decision-making as a field means fighting for those individuals and families to be supported throughout the lifecycle.  The choice to live in a world that offers no support or resources is no choice at all for most people.

 

LET’S TAKE A STAND

It is extremely unfortunate that healthcare, a subject of mutual concern and importance to all Americans, is now held hostage to the ignorant, pettiness of slogans on signs that angry partisans wave at campaign rallies. No professional organization wants to get embroiled in party politics. On the other hand, there are times when everything you believe in is threatened and you have to take a stand. I believe this is one of those times.

 

I’m hardly alone in this. The AMA released a statement yesterday opposing Graham-Cassidy. So have many other groups representing healthcare professionals and patients, a number of them listed here in Jimmy Kimmel’s eloquent denunciation of the bill (comedians must lead when politicians are clowns, I suppose, and what else can he do when our government is beyond satire?).

 

So please, NSGC, make us proud with a statement against this terrible bill. Let’s take a stand for our values and, more importantly, for our patients.

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Will H.R. 1313 Allow Wellness Programs to Undermine Your Rights Under GINA? Inquiring Constituents Want to Know…

It’s 2017, and it’s hard to keep track of the reasons to be outraged, but here’s one with special relevance to the genetics community: H.R. 1313, the Preserving Employee Wellness Programs Act (alternatively entitled H.R. 666, the Unfortunate Erosion of GINA Act).

There are two main questions we should be asking about H.R. 1313. One, what does it do? And two, why does it exist? For the first, what the law would do (if passed) is allow so-called wellness programs to circumvent the limitations on data collection by employers set out in the genetic non-discrimination act (GINA) and the Americans with disabilities act (ADA). I say so-called wellness programs because in point of fact they have not generally been demonstrated to make people, shall we say, well-er. Which raises the question of why Congress is so keen to make sure they are maintained, but we will get into that later.

Under GINA, employers are not allowed to purchase, request or require genetic information from their employees. The assumption behind this point of law is that employers who had that information might be tempted to try and reduce their exposure to risk by discriminating against those in their risk pool (or their dependents) with increased susceptibility. Alternatively, they might try and use genetic information as a part of decision-making about promotions or assignments. Some of the people attacking the bill have pointed out that attempts to use predictive genetic information are at present likely to be absurdly ineffective and misguided, but this only makes the acts of discrimination more random, not more (or less) nefarious. If they could do it with pinpoint accuracy, it would still be unfair.

Exceptions for wellness programs already exist under GINA, to allow these programs to ask the participant about genetic conditions or genetic testing. As the law stands, the employee must participate voluntarily, and individual identifying information must be collected by a licensed or certified health professional (including, specifically, a genetic counselor) and cannot be shared with the employer except in the aggregate. As for voluntariness, H.R. 1313 would alter this dynamic by sleight of hand – employers are not allowed to charge people more for insurance if they don’t participate, but they are allowed to offer incentives for employees who do participate, and those incentives can be up to 30-50% of their total healthcare contributions. Got that? We’re not charging you more, people who don’t give us your genetic information, we are simply charging the other people less.

 (Sidebar: perhaps we can get corporations to introduce wellness programs that require employees who participate to vaccinate their kids, while the ones who do not pay thousands of dollars more per year in health insurance costs. Vaccines, after all, are the best validated wellness program that we have. Just a thought.)

 The second and most serious charge that has been made about H.R. 1313 is that it would eliminate privacy protections that exist under GINA, and give your employer access to genetic information about employees and their family members. This has been reported in a number of places (in the NY Times here and in STAT here) but is disputed by the NSGC fact sheet circulated on, forebodingly, the ides of March. The bill doesn’t refer to the issue of sharing genetic information specifically, and it seems reasonable to assume that those protections you have under GINA would be in force unless specifically taken away, HOWEVER, there’s obviously room for doubt, given all the doubt. Take home point: the bill should be amended to include a clear message that genetic information is private and cannot be shared with employers (or, for that matter, sold – as commonly happens with wellness programs today).

Which brings me to my second question: why does this bill exist? Identifying the beneficiaries might shed some light on what it is intended to do. Employers might like the bill, if they see it as allowing them to shift health care costs to non-participants via the incentive system (lower costs for some being alternately described as higher costs for others). If we are being pie-eyed optimists, we could imagine that employers are just determined to see you healthy, although in that case they might be put off by the absence of any compelling evidence that these programs work. If we are being conspiracy theorists, we might wonder if some employers see an opportunity to obtain information on the health and health risks of employees and their dependents to which they are denied access under GINA.

Obviously the law is a boon to the ‘wellness’ industry, which Congress is nurturing with this sack of high quality manure while asking in return only that the wellness program not be “highly suspect” as a method to “promote health or prevent disease.” Ah, the old, ‘not highly suspect’ standard.

Perhaps, say you, another beneficiary of the law is the employee who receives a rebate for being healthier. Yes. I’m all for lower health care costs. But since the wellness programs don’t actually make employees healthier, but may identify employees (and their dependents) with more health risks, their benefits come by chasing people who need insurance out of their insurance pool. Companies could keep their own overall costs the same by dropping everyone’s premiums by some intermediate amount, which would help all employees with the added benefit of not being a human rights violation. Food for thought.

On March 8th, the American Society of Human Genetics (ASHG) came out with a strong statement opposing H.R. 1313, quoting director of science policy Derek Scholes as saying that “If enacted, this bill would force Americans to choose between access to affordable healthcare and keeping their personal genetic and health information private….Employers would be able to coerce employees into providing their genetic and health information and that of their families, even their children.”

The response from NSGC has been more nuanced, prefacing a statement on their concerns about H.R. 1313 with the caveat that “NSGC supports the collection of family health history information.” Without taking an official position on the bill, NSGC has indicated concern about voluntariness and privacy protections, proposing that in its final version, “the bill should explicitly reaffirm the GINA discrimination protections, roll back penalty language altogether, and limit rewards, among others. NSGC would also support further study of the value of wellness programs, and their focus to ensure the programs can indeed positively impact health.

Privately and publicly, I have heard comments from members of the genetic counseling community who are concerned about H.R. 1313. This bill has gathered a fair amount of negative attention and there is a good chance it does not move forward, at least not in its current form. I don’t say this to discourage grass roots activism; in fact it’s the opposite – evidence suggests that public pressure is having an impact. So call your Member of Congress! (we all have our elected representatives on speed dial by now, right?). Here’s a quick summary of three points worth making:

  1. Participation in any program that includes gathering genetic or family health history information on the participant and/or family members should be truly voluntary, and should not be associated with substantial rebates or incentives.
  1. Wellness programs should be explicitly required to conform with the privacy protections for genetic and family health history information that have been established by GINA and the ADA. Congress should pass no laws that erode or diminish these important civil rights protections.
  1. Laws creating special exemptions or accommodations for wellness programs should include a standard for wellness programs based on an objectively assessed, documented record of improved health outcomes.

 

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