What’s actually in the bill

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Because I am the nerdiest nerd around, I actually read the relevant portion of the stimulus bill. And while I was doing that, I took notes. In outline form. Which essentially reproduced the TOC at the beginning of the bill, but in a format that’s easier to read and understand. So if you happen to be curious about what’s actually covered in the HITECH Act, or what kind of form it’s in, check this out.

(You can, of course, also read the whole bill here.)

Title XIII – Health Information Technology

Sec. 13001. Short title; table of contents of title.

Subtitle A – Promotion of Health Information Technology

Part I – Improving Health Care Quality, Safety, and Efficiency

Sec. 13101: Standards Development and Adoption. (Adding to Public Health Service Act.) These sections comprise Title XXX of that act.

Sec. 3001. Office of the National Coordinator for Health Info. Tech.

Sec. 3002. HIT Policy Committee

Sec. 3003. HIT Standards Committee

Sec. 3004. Process for adoption of endorsed recommendations, adoption of initial set of standards, implementation, specifications, and certification criteria.

Sec. 3005. Application and use of adopted standards and implementation specifications by federal agencies.

Sec. 3006. Voluntary application and use of adopted standards and implementation specifications by private entities.

Sec. 3007. Federal health information technology

Sec. 3008. Transitions.

Sec. 3009. Miscellaneous Provisions.

Sec. 13102. Technical Amendment.

Part II – Applications and use of adopted health information technology standards; reports

Sec. 13111: Coordination of federal activities with adopted standards and implementation specifications

Sec. 13112. Application to private entities.

Sec. 13113. Study and reports.

Subtitle B – Testing of Health Information Technology

Sec. 13201. National institute for standards and technology testing.

Sec. 13202. Research and development programs.

Subtitle C – Grants and Loans Funding

Sec. 13301. The following will be added to Title XXX of Public Health Service Act, as created above.

Subtitle B – Incentives for the Use of Health Information Technology.

Sec. 3011. Immediate funding to strengthen the health information technology infrastructure.

Sec. 3012. Health Information Technology Implementation Assistance.

Sec. 3013. State grants to promote health information technology.

Sec. 3014. Competitive grants to states and Indian tribes for the development of loan programs to facilitate the widespread adoption of certified HER technology.

Sec. 3015. Demonstration program to integrate information technology into clinical education.

Sec. 3016. Information technology professionals in health care.

Sec. 3017. General grant and loan provisions.

Sec. 3018. Authorization for appropriations.

Subtitle D – Privacy

Sec. 13400. Definitions

Part 1: Improved privacy provisions and security provisions.

Sec. 13401. Application of security provisions and penalties to business associates of covered entities; annual guidance on security provisions.

Sec. 13402. Notification in the case of breach.

Sec. 13403. Education on health information privacy.

Sec. 13404. Application of privacy provisions and penalties to business associates of covered entities.

Sec. 13405. Restrictions on certain disclosures and sales of health information; accounting of certain protected health information disclosures; access to certain information in electronic format.

Sec. 13406. Conditions on certain contacts as part of health care operations.

Sec. 13407. Temporary breach notification requirement for vendors of personal health records and other non-HIPAA covered entities.

Sec. 13408. Business associate contracts required for certain entities.

Sec. 13409. Clarification of application of wrongful disclosures criminal penalties.

Sec. 13410. Improved enforcement.

Sec. 13411. Audits.

Part 2: Relationship to other laws; regulatory references; effective date; reports.

Sec. 13421. Relationship to other laws.

Sec. 13422. Regulatory references.

Sec. 13423. Effective Date.

Sec. 13434. Studies, reports, guidance.

A brief addendum on Electronic Records

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I forgot to mention that the short title for this bill is the “Health Information Technology for Economic and Clinical Health Act,” or the “HITECH Act.” How cute. Somewhere in Washington, there is some staffer who just LOVES doing this stuff. I mean, honestly… “Economic and Clinical Health”? As though they were really just two varieties of something essentially similar? Chocolate and strawberry ice cream?

-Lawyer

Ping-Pong Post: Electronic Health Records

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The stimulus bill includes an extensive title on Health Information Technology. And your very own “Lawyer” read the entire Title. (Okay, fine. She skipped the section on grants and loans. But she read the rest of it.)  Let’s take a look at the good, the bad, and the ugly.

Lawyer: If we could absolutely guarantee total privacy of these records, (granted, we can’t,) would there be objections to the system? There are clearly many potential benefits — both for any individual patient’s care (diagnosing, preventing duplicate tests, avoiding drug conflicts, more please, nurse?) but are there any potential pitfalls from a healthcare standpoint?

Nurse: There is the potential for a provider to be lazy or for a tricky diagnosis to be missed if we assume that the record is accurate, or we are influenced by what someone else has entered. Also I would like to think that knowledge of previous conditions or things like drug abuse would only be used in a patient’s best interest, but some healthcare providers judge and discriminate inappropriately. It might be easier to do this with electronic medical records.

Lawyer: Privacy is obviously a huge concern. Of the 60-some page section of the bill devoted to this program, 20-some are devoted exclusively to the privacy and security measures being undertaken, including the appointment of a point person whose entire job is to oversee the development, testing, and approval of security measures for this thing. What are the practical concerns about security? I mean, yes, there is the icky feeling of violation, and that is legitimate. But beyond that, what should we fear?
What else? What are we *actually* afraid of here?

Nurse: When people rely on private, employer-based insurance, they may be denied coverage for certain conditions, or they may face discrimination.

Lawyer: So I guess the question is who is going to have access to what parts of these records. The bill doesn’t specify – it only specifies which entities and various appointed people will set these standards and develop and assess the technologies to carry them out.

Nurse: There are already more stringent privacy laws attached to diagnoses like HIV. How will this be carried forward? How is that protection approached in the context of a comprehensive and accessible electronic record?

Lawyer: Another really good question. And I don’t know – I don’t know how it works now, either. I do know that the law specifies the use of limited data sets, with a minimum-necessary standard – so in, say, a public health or research setting, your name, SSN, etc, would never be attached to your sensitive diagnoses.

Nurse: I think it’s possible, also, that patients would delay care or avoid medical situations if they didn’t want something in their record of if they knew something was there.


Lawyer: The authors of the bill are definitely aware of that concern – but I’m not sure they have a good solution. They even mention that concern specifically in the bill and specify the need for educational efforts to reduce that sort of behavior.

On a related note, one of the provisions that’s been catching a lot of attention is that they’re attempting to establish an electronic health record for every person in the United States by 2014. It looks like (though I’m not entirely sure how to interpret this language) people can request that their information not be disclosed, as long as the request isn’t surrounding the need for payment for a service. (You can’t opt out of having the information about what procedure was performed that they owe money on go to your insurance carrier unless you’re paying for it out of pocket.) And even then, it will be a “minimum necessary” disclosure. Which I guess makes sense.

Nurse: What if information is lost or stolen, what are the backups in place? There have been several recent cases of hospitalized celebrities having their privacy breeched. I see potential for that kind of abuse here.

Lawyer: The way this bill is written, it’s already assuming that we will come up with security provisions that are sufficient. The bill doesn’t specify what the safeguards will be – it discusses how they will be evaluated and adopted. It also discusses the penalties for entities that allow any sort of security breech. In other words, we’re no longer asking whether this might be feasible. We’re assuming it will be, though we don’t yet have the measures in place or the technologies developed. Is this warranted? TJ Maxx might’ve been broken into, but online baking remains safe and secure. So my feeling is, it should be fine, as long as sufficient care is taken, and it’s certainly written into the bill.

Nurse: The perfect is the enemy of the good, and it’s not perfect now, so we do stand to lose by getting bogged down. Where is the dividing line between useful improvements and endless legal tinkering? There are MANY advantages:


-It would potentially save a lot of money, both in unecessary tests and treatments and in provider hours used, to have medical histories accessible even for patients who cannot tell us or don’t know their own history. Even in my limited clinical experience, I’ve seen a number of criticallly ill patients without a good history, and this undeniably affects our ability to give them the best care.

-It could potentially be life-saving to have pertinent medical info at hand when a patient arrives in an emergency situation—knowing an allergy or a condition or a blood type, for example.

-It would cut down on unintentional errors and intentional abuse that occurs when a single patient sees multiple doctors and doesn’t mention all medications and treatments being used. Allowing pharmacies and physicians to access an entire record would absolutely help to avoid what are now strikingly common errors.

-Within a hospital, even, it makes a difference. I’ve worked at places where different parts of the record and orders systems were computerized, and there are far fewer mistakes and generally less wasted time when the paper steps are removed all together.

-Patients can be greatly empowered by having access to their own health information. It would also perhaps help to promote accountability on the part of providers.

Lawyer: Yeah! Way to go, Nurse. I would like to point out that the bill dictates the composition of the HIT policy committee, and it specifies two health care providers, one of which must be a physician. It doesn’t say anything about the other, but they’d better pick a NURSE! Also, think the office of the National Coordinator will need a legal intern in the summer of 2010? Cause I might be available…

Ping-Pong Post: Medical Research in the Stimulus

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An  article about money in the stimulus bill for comparing the effectiveness of different treatments for the same illness:

http://www.nytimes.com/2009/02/16/health/policy/16health.html?em

LAWYER: Basically, the government is giving researchers a billion dollars to figure out which treatments actually work best. And I’m all for it — at least in theory. We still lack even a basic understanding, in some cases, of how treatments actually work. Many came into being through accidents — observed side effects of treatments intended for something else entirely. Many are still used just because they always have been, without any particular evidence for great improvement in patients.

NURSE: Well, this proposal isn’t to fund research into how treatments work, but whether they do so better than others.

LAWYER: Yeah, yeah, you’re right. But that’s one of my favorite pet arguments! When I worked in an academic research lab, we sometimes collaborated with people in the hospital, and our goals were always so different! But this is an effectiveness thing. You’re right.

NURSE: (Just as an aside—Viagra was originally created as a cardiac drug! But I digress.) This is part of a trend in medicine (and nursing) towards adopting more evidence-based practice (to use the lingo!). The degree to which non-evidence-based practices are used is staggering.

LAWYER: More information can only help the situation, right? Don’t we really need studies of these treatments that *aren’t* funded by the people selling them?

NURSE: Yes, we DO need studies to evaluate the relative efficacy of all kinds of treatments that are done without conflict of interest. I don’t think that looking for inexpensive treatments is a conflict of interest, so long as no one who stands to profit is funding (hence the problem with big pharma funded studies).

LAWYER: Is it ever that simple?

NURSE: NO.

LAWYER: I love the simplicity of that answer.

Some questions to consider:

LAWYER: How much is cost the motivating factor in choosing treatments? The idea is that this research save us a lot of money and save lives by eliminating costly and ineffective treatments. But does that mean that costly treatments should have to perform to a higher standard? Should a slightly less effective treatment (as deemed by these new studies) be endorsed if the difference in efficacy is very small but the treatment is significantly less expensive? If there were a way to study the effectiveness of treatments on a cost-blind manner, should we?

NURSE: I think that cost is a huge motivating factor, and that’s OK. I would argue that, by and large, it is OK to give a slightly less effective treatment to an individual to serve the greater good of improving the overall problems with the cost of healthcare.  (Is spending 16% of the nation’s GDP on healthcare sustainable? I would think we would be worse off in the long run if we stick to this kind of system.) I don’t mean that we shouldn’t use costly treatments, but rather that we should only use them when they are proven to significantly improve outcomes.

LAWYER: Significant meaning what? P<0.001? I mean, it’s kind of hard to say, this other treatment might be a little bit better, but it costs too much to use it all the time, so you’re a little more likely to die, but we’re not broke! (That problem of being all for improving the system, but not if I have to sacrifice my own personal precious choices to get there…)

NURSE: We already DO substitute equally effective, or close to equally effective, treatments which are less costly, either as institutional policy or in an attempt to increase compliance from individual patients. We DO give generic drugs rather than brand-name when they are equally effective, or similar. And as it stands, patients don’t have total control over what treatments they are offered, and I’m not sure that they should be. I’m veering into a different territory, though, if I ask whether you should be able to buy your way out of dying when someone else cannot.

LAWYER: How similar is similar:

Is it worth spending all this time and money playing with existing treatments for diseases when there are many diseases that still have no effective treatments? (Where’s that cure for Huntington’s disease or that HIV vaccine?)

NURSE: Well. . . obviously there are never enough resources for everything, but I would argue that yes, it is worth it when they are diseases like diabetes, hypertension, breast cancer, or depression that effect huge segments of the population. I don’t think that you could pick a single disease without a cure or vaccine and put all our eggs in one basket. This measure needs to be part of a multi-faceted approach to research, and it is.

LAWYER: Couldn’t this lead to the limitation or even elimination of treatments (either through regulation, or by insurers refusing to pay for alternative or expensive treatments)  that might actually still be needed? I.e. if some of these studies find that a certain drug doesn’t tend to work as well as a quick and easy surgical procedure that corrects the same condition, couldn’t a patient who really would fare better with the drug be denied that treatment because it was deemed ineffective, because his insurance company would cite the well-regarded study saying that the drug was inferior to the surgery? If your doctor says that this treatment is best for you, but the congressionally-funded study  says a different treatment is more effective, your insurance company might well deny coverage for the treatment recommended by your doctor. Not good!

NURSE: Good point. Overall, it seems likely that the majority of patients will receive better care though a system like this. There is much disagreement about the best treatment courses for many very common conditions, and strong evidence could help to equalize the kind of treatments available to patients in different areas with different doctors.

Government can examine safety and efficacy, yes—it’s an issue of protection. Appropriateness to a particular condition in a particular patient, no—this is why people go to medical school, no?

LAWYER: Yes, and it’s great that they do. But it’s not great if they aren’t able to make the decisions they’re trained and paid to make. Would the money come with strings attached? Meaning that the results of studies funded through this bill wouldn’t simply become information that doctors and patients can access in making choices, but rationales for government regulations (and perhaps more likely, insurance company decisions)
about what constitutes appropriate care, rather than leaving these decisions to doctors and patients?

NURSE: I also think it is crucial that whatever comes of the research, the government should not be able to dictate and enforce treatment protocols. This is a health care provider’s job, and the government is incapable of performing it well. We need to ensure that the powerful information generated is not mishandled.

LAWYER: Amen, sister! Though if people heeded the advice of your previous post, that would become less true…

NURSE: Generating strong evidence will cause changes in practice, especially as an older generation of physicians ages out of practice, whether or not it is mandated. Making strong evidence freely available and highly visible is far enough. This doesn’t solve the insurers problem, and that’s a doozie. I think we cannot ignore what public and private insurers could do with the data if left to their own devices. Companies with their eye on the bottom line may make decisions that are not in the best interest of the patients’ health.

LAWYER: I wonder if it would be possible to create legislation that forbids insurance companies to use approved empirical research in this way — that says if the doctor signs a statement certifying that there is a medical advantage to a certain treatment, the insurance company MUST cover it as it would the “preferred” treatment. (I wish I knew the existing laws about this … I’ll get there soon… I’ll get back to you in a year or two…)

NURSE: Insurance companies are masters at denying payment for all kinds of reasons, and if there’s a loophole to be found, they’ll do it, even if something is supposed to be illegal.

LAWYER: Might these types of studies create a false sense of certainty about some treatments? They may be in general more effective, but that doesn’t make them right for any particular patient. Do you think doctors might be vulnerable to this sort of clinical laziness?

NURSE: It’s possible. I don’t think it’s a chief concern, though.

LAWYER: Finally, the bill creates a council of federal employees who will basically decide how exactly to spend the money. So… how should they spend it? Which kinds of conditions most need or deserve the research? Which institutions? Should we focus on the most common ailments, or the most costly? The most dangerous, or the most contagious? Those that can’t be prevented by lifestyle choices?

NURSE: Like I said above, I think that there are some very common and very treatable diseases eating up a lot of our resources, and we stand to benefit most by focusing there in the comparative research. There may be only a handful of treatment options for largely fatal and rare diseases, and the comparative studies are really meant to sort through heaps of options for treatment.

LAWYER: Is there any merit in allocating resources preferentially to diseases that can’t be mitigated by lifestyle choices? (i.e. should we spend a lot of money on Type II diabetes and less on breast and prostate cancer, even though you can do a lot to prevent diabetes?) I see the point of wanting to make progress on the most common diseases where the most waste is likely to be occurring, but don’t we know for pretty darn sure that maintaining a healthy weight/diet can stave off diabetes?

NURSE: Well, because the focus is not on creating new treatments but on weeding out ineffective ones, I don’t know that there is really a strong argument there. Obviously prevention is better than treatment,  but proven prevention methods don’t mean that there’s not an epidemic. We know lots about preventing diabetes, but there are many, many diabetics, and many, many treatments—so this scenario lends itself well to this kind of research.

LAWYER: The money will be in the purse of HHS — currently a captainless ship. Who’s gonna take that over? Is it a different job, at all, with this responsibility includes?

NURSE: See my previous post, re: nurses in legislatures! One extra point: This article points out, as the Congressional Black Caucus astutely picked up on, that minority groups are vastly underrepresented in medical research. We know way more about works for middle-aged white men than anyone else. How is this addressed? (The final bill says that women and minorities shall be included—we need to keep an eye on this!)

LAWYER: And whether diseases that are much more common in minority populations are adequately included. I wonder what “shall be included” really means. Or rather, how it will be interpreted. I doubt they’d leave out breast cancer, for instance, but… sickle cell?

LAWYER: Side note: I realized for the first time today that in the “Health” section of nytimes.com, they have the stories categorized  — Research, fitness & nutrition, views, health guide, and…. money & policy? Those two are the same category? I suppose our last two topics of discussion here have pointed firmly in that direction, but goodness! Are they really so tightly intertwined that we can’t consider them separately?  (I might have to file this one away, along with knowing that you can’t make people be responsible, in my file of truths that make my stomach burn, and then get back to work.)

Nurses as Legislators

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Nurse says:
I recently read an article in Imprint, which is the magazine of the National Student Nurses’ Association, about nurses working in the federal government (Suzanne Begeny, “Caring for Patients Through Federal Legislation,” Imprint, 56 (1).)  This article pointed out that much of the healthcare legislation in this country is drafted by young legislative assistants who have never worked in clinical practice and do not have much, if any, experience with ground-level healthcare. Although this article focused on careers in lobbying for nurses, which tend to focus on nursing issues, it opened the door for discussion on expanding the nurse’s role as an advocate. Nurses are trained to advocate for our patients at the bedside and to help them navigate through backwards policies that prevent them from receiving care.  It got me wondering how we can turn this advocacy into a bigger-picture effort in advocacy—such as through state and federal legislatures.

A quick internet search reveals that there are more than a few nurses who serve in state legislatures and administrations (http://nursingworld.org/MainMenuCategories/ANAPoliticalPower/State/Nurse-Legislators.aspx). Arizona has, as of the publication of this resource (2008), Rep. Cheryl Chase, LPN, and Rep. Colette Rosati, RN. Interesting!  I feel that many nurses identify very strongly as nurses—it’s not just a job to many of us, but really a calling and an identify. I’d love to see this strength vocalized in legislatures!

When the new Obama administration gets around to working on a healthcare initiative, who better to participate than nurses? Listening to the wisdom and experience of people working on the front lines of the healthcare system has enormous potential to change the system for the better.

More on advertising. . .

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Nurse Says:

Like it or not, there are providers who will write a prescription for pretty much whatever drug the patient requests. Advertising makes this scenario more likely by increasing patients’ awareness of certain brands. By and large, drugs that are prescription-only may have serious side effects, require careful dosing and monitoring, treat serious conditions, and more. Health care providers with prescriptive authority are equipped to evaluate the appropriateness of such medications in a way that the general public is not. Unfortunately, however, many prescriptions are written with no instructions or education provided at all. Often, the doctor is halfway out the door and doesn’t have time for questions (this is not necessarily his fault—more on that another time!). Patients are given the opportunity to ask questions at the pharmacy, but the pharmacist isn’t familiar with the patient’s medical history in the same way. I happen to feel that nurses excel at this kind of teaching, but again, we often lack the time or opportunity to provide it. When patients must seek out their own information or ask questions instead of being taught up front, they may never get important information. Even though pharmacies include information leaflets with many prescriptions, does anyone read those? Especially people with poor eyesight or literacy skills?

Patients who learn about drugs from advertisements may feel that they have enough knowledge to use the drugs properly when they receive a prescription, and they may develop unrealistic expectations. Without the teaching that is necessary to safely and effectively use drugs, patients can be in danger. A health care system where patients get more information from advertising and less from health care providers is a dangerous place. As the saying goes, a little knowledge is a dangerous thing.

How can we ensure patient safety? Through better education efforts (nurse) and stricter regulation of drug advertisements (lawyer)!

Advertising Woes

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Lawyer says:

You may have seen them: the TV ads for birth control pill Yaz that explicitly state that the FDA has asked the company that makes it, Bayer, to correct their previous advertising. Or, like me, you may have missed all that until the New York Times ran this aritcle about the campaign. But either way, it’s a rare occurrence, and an interesting one. The FDA has stepped in and said no, you can’t run these ads, they are too misleading, overstating benefits and understating risks. And though I don’t know that Yaz was especially worse than any other drug, the intervention was overdue.


While there is a part of me that wants to defend Yaz to the end because it shares a name with one of the great heroes of the best baseball team ever, the rest of me says, good. While requiring a corrective ad campaign is far from ideal, paying more attention to direct-to-consumer marketing of drugs is a big step forward.


Since when were drugs — prescription medications with complex risks and benefits — like cars, products from which people could just choose the particular features they found most appealing and then pull out their checkbooks? I’m all for information being made available to consumers. After all, we’ve all seen those pens, calenders, notepads, luxury travel, and hefty speaking fees that doctors get from pharmaceutical companies hoping to put their brand names on the tips of professional tongues, and no patient wants it to be swag that causes their doctor to recommend one drug over another. (Did I hear a rumor about that coming to an end?) But advertising isn’t the way to do it. The information is out there — the NIH and the National Library of Medicine sponsor a website called Medline plus that provides information about just about every prescription and over-the-counter medication that’s out there — but it isn’t put in friendly terms with cute, smiling girls and couples frolicking on the beach. It isn’t interrupting American Idol or whatever else is on these days. (That’s right. I don’t have cable. The TV hasn’t actually been turned on in… I don’t know. A while.)


The point is, direct-to-consumer marketing of pharmaceuticals needs more oversight — BEFORE the ads reach millions of viewers who don’t have the time or expertise to sift through all the technical information themselves. And drug companies should no longer be allowed to woo doctors with the sorts of perks that raise eyebrows all over Washington when they involve lawmakers, which will allow drugs to speak for themselves.


Thoughts? Information about limitations on the wooing of physicians?

Ping-Pong Post: Octuplets

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Here at nurse and lawyer, the ping-pong post will be a regular feature. These posts will feature discussion between nurse and lawyer using the news as a jumping0ff point.

The recent octuplets case raises several issues in medical ethics, and the extreme nature of this particular case raises questions about when/if there is a role for the law in such situations. Although we don’t know many details about the specific situation, there are issues of law and bioethics begging to be debated! We’re discussing the case in the framework of some basic ethical issues as a jumping-off point.

JUSTICE
Nurse: The family which now includes 14 children is using an enormous amount of resources, including welfare (financial support) and healthcare and education resources.  No one likes to talk about financial cost when human life is involved, but it’s really unavoidable. Because the birth of octuplets was the product not of natural conception but of a medical procedure, it becomes a question of whether those resources are being distributed in a way that is just.  Are families and children who were not the outcome of medical interventions more deserving of resources? Should procedures that stretch resources, like IVF, be regulated with an eye towards resource utilization? Distributive justice also comes up in issues like organ transplant.

Lawyer: Unlike organ donation, welfare/healthcare/education is not a zero-sum game. We hand out more if more is needed, taking our loans and raising taxes to pay for it – there’s kind of a “we’ll deal with it later” attitude. It’s good that we can do this, because immediate needs get addressed no matter what the resources, but it also means that needs can be created without being as mindful of the potential consequences. (Would people be less likely to take the health risks of smoking seriously if lung transplants were fairly simple and we had an endless supply of lungs, for free?) And it’s not just we’re dealing with here, but our already overtaxed healthcare and public education systems. Adding eight students to a kindergarten class or caring for eight premies in a NICU is no small matter.

I say this not to shame any particular individual, but to raise questions about protecting our resources. It doesn’t seem like anybody did this on purpose, so how was it allowed to happen? We’re not even talking about limiting the things that people choose to do (if people want to have fourteen kids, and set out to do it themselves, they are allowed,)so much as limiting the possibility for such costly accidents. Which is much more palatable in terms of individual liberties.

BENIFICENCE/NONMALEFICENCE
Nurse: Ideally, the doctor/patient relationship is private, some might even say sacred, and not open to the prying eyes of anyone, including the government. Certainly HIPAA has had a lot to do with how this is approached. By this standard, the law cannot intervene in the decision between doctor and patient to perform IVF, or how to perform it, or when it is and is not appropriate.

Lawyer: This certainly isn’t entirely respected in, say, assisted suicide, where politicians get right in the middle of those conversations. Same with abortion.

Nurse: We must ask, then, is IVF a medical treatment that treats a condition (i.e. infertility)? Does that change if the patient already has children? Is there a line there? We react very differently to a woman with six children having IVF than we would to a woman with no other children or with one child.

Lawyer: It seems like it would be pretty much impossible to actually draw a line. (IVF is a medical treatment for women who have four or fewer children, but not in other cases? The number would pretty much have to be arbitrary, because what constitutes a reasonable/safe/responsible number of children varies so much according to circumstances.)

Nurse: Does there need to be psychological and/or social examination of candidates for IVF? I’m sure there are standards of care that require at least cursory exploration of a patient’s understanding of the procedure and its potential outcomes. This is part of basic informed consent!

Lawyer: There are laws in many states that require counseling for an abortion. According to the Guttmacher Institute, “33 states require that women receive counseling before an abortion is performed: 23 of these states detail the information a woman must be given; 10 states have abortion-specific requirements generally following the established principles of informed consent. ” There are guidelines for counseling with an HIV test, but not legal requirements, to my knowledge. In some states, the health authorities are actually required to distribute specific written materials to women seeking abortions. Could similar requirements for IVF – more stringent than a generic informed consent requirement –  prevent the accidental birth of “extreme multiples”?

Nurse:Ms. Suleman has claimed she did not know she could be carrying multiples—and this was not her first IVF pregnancy. She was either lying, or did not have enough understanding to consent to the procedure either time. Is she, or is the physician, legally or ethically wrong?

Lawyer: There is a third possibility — that the clinician involved was negligent in explaining the procedure and its possible and likely outcomes to her. In this case, there actually might be some legal remedy.

Nurse: It’s tricky! She would have had to sign a document indicating her understanding and consent, but that consent needs to be witnessed and the physician should not accept it if he/she feels that the patient has no understanding. Of course, “sign here!” “OK!” happens all the time, and once the signature is on the dotted line, it’s harder to challenge, no?

Lawyer: Yes, but a signature on a waiver that is really quite obscure and packed with fine print isn’t likely to be upheld by a court. That’s part of why we’ve been seeing a lot of waivers and warnings that say things like “Serious injury or death could occur!” on things that seem relatively benign – it needs to be effective as a warning, in addition to a contract, to have value. So if the form she signed was in legalese and medicalese, and written in 10-point font, there may be some wiggle room.

Nurse: Allowing a woman to carry eight fetuses is dangerous to the mother and to all of the fetuses. Of course, IVF is very individual. The number of embryos implanted and the number which “take” can vary widely. Eight is outside of the normal practice. Does that make it wrong? Would it be wrong in a patient when previous attempts at IVF with fewer embryos had failed?

Lawyer: While we clearly can’t regulate how many children someone could have (hello, 14th amendment!) I think we could, and probably should, regulate how many fetuses can be implanted at once. I don’t know who would regulate that – the FDA? Perhaps there could be a limit, with an exception for women with a history of unsuccessful implantation. Ms. Suleman had a history of successful implantation, with four single births and a set of twins, all through IVF, never with more than six implanted at once . Such a regulation would likely have prevented her situation without preventing a mother who had tried unsuccessfully with fewer embryos from exploring further solutions to infertility.

AUTONOMY
Nurse: There is not a universal tool or practice for determining a patient’s understanding of a procedure. There are screening questions and health literacy assessments, but no universal practice that really evaluates understanding. This is not IVF-specific; any invasive procedure requires informed consent. Some institutions use “teach-back” technique requiring the patient to explain the procedure back in their own words before signing the consent document. If a patient cannot do this, do they have the autonomy to make the medical decisions?

Lawyer: I can certainly envision situations in which a procedure is so complicated, or relies on an understanding of how systems function in the body to a degree that a patient with no medical training and/or limited intelligence might not be able to understand it. Does that mean that the patient shouldn’t have the treatment? I wouldn’t want to start down that slope. (Are you smart enough to understand, and thus receive, this treatment?) On the other hand, if the patient is required only to repeat back the possible and likely outcomes (I understand that I could have anywhere from zero to eight fetuses in my womb as a result of this procedure, that carrying more than four at my age could pose a serious health hazard, etc, etc.) then the responsibility is firmly on the patient again.

Nurse: Should selective reduction be mandated in cases of great risk? This is, of course, a very uncomfortable question and I think you’d be hard-pressed to find someone who would say yes, but why not? A woman who is pregnant with octuplets due to IVF is at a very high risk for health problems or even death, as are eight fetuses. She is also likely to consume enormous amounts of healthcare resources. We have the ability to reduce that risk substantially. (I am not advocating this as a policy—just exploring the idea!) The objections to selective reduction are generally similar to those to abortion, although it’s perhaps complicated by the “playing god” character of IVF.

Lawyer: I think the real question there is, at what point does it become a health decision about other beings (fetuses) who also have rights? Mandating selective reduction would be the state saying that it has the duty to protect those fetuses – which leaves you in quite a pickle, since the means of protecting them include destroying some of the very things you’ve just claimed have the right to protection. Are you dizzy yet?

CLOSING THOUGHTS:
Nurse: While there are standards in medical ethics, they are rarely codified in law. There will always be practitioners who will be willing to push the envelope in ethics—there isn’t a way to hold them legally accountable for these questionable actions. Should there be?

Lawyer: Even if there should be – and frankly, I’m not sure they should, since doctors are much better equipped than politicians to make these sorts of decisions, I’m not sure there can be.Many of these things are impossible to make laws about, either because it’s really too paternalistic to succeed under our constitution (which values personal liberty so highly) or because the issues vary too much from case to case to make any kind of policy that would be effective. Maybe it’s more of an issue for state medical boards and ethics committees?

Healthcare questions:

Nurse: as much as we hate to say it, healthcare providers may “judge” patients morally, and this can disrupt the quality of care. As all involved are human, it seems this in inevitable to some degree. Will this woman and these children receive sub-par care? Will they be subject to the same kind of discrimination that happens to others who are financially poorly off?

Lawyer: Purely as a thought experiment, I launched myself down this path: we can’t legally limit the number of children. But what if we limited how much help you could get from things like welfare, food stamps, and medicaid? Obviously, the people who would suffer fastest and most from that would be the poor children. But if the mother is not able to care for them with her own resources and whatever is designated as her reasonable share of public resources, she is likely to become a negligent parent — I don’t know what the rules are, but at a certain point, wouldn’t the state remove the children from her home, if she demonstrates an inability to care for them, be that psychologically or financially? Let some poor couple who would otherwise undergo IVF and accidentally have quintuplets take charge of a baby or two. Okay, that last part was purely whimsical. I’m just carrying the possible outcomes of something like this to their logical extremes to see where they get us.

Nurse: I think you found the main issue with that, which is that the victims would be the children. If we knew there was a child protective service that was swift and efficient, that would be one thing—but there isn’t!

Lawyer: I think this blog post is too long. We’d better stop.

Nurse: Yes, to prevent eye strain for our readers.

Coming soon…

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Welcome to Nurse and Lawyer. Soon, this will be a blog about bioethics and the law, written by a set of identical twins: a registered nurse, and a soon-to-be-lawyer. We share DNA, sure, but also an interest in bioethics and the tough choices faced by health care providers, legislators, patients, family members, lawyers, and judges. Here, we will discuss issues that come up in the news, along with hypotheticals we dream up, from both a nursing and a legal perspective, with guest posts from our father the molecular biologist and various associates and friends who work in related fields.

Check back soon!