Potato Chips and Choice Architecture

By Nathaniel Counts

If, out of concern for public health, the government banned potato chips today, a lot of people would get very angry.  Only some of these people would be angry because they missed potato chips.  For most it would be the principle of the thing – the government should not interfere with our autonomy to eat whatever we want, as long as it does not harm others, and some days this will include potato chips.  I would posit that the autonomy at issue here is a narrow understanding of autonomy, and one that we should be suspicious of.

Imagine yourself in the biggest Costco in the world.  It has every food in existence and they are all placed equidistant from you, and you may survey the scene and choose whatever food you most desire and then eat it.  This would be true autonomy.  The world we live in, however, is deeply constrained and we should question how meaningful our autonomy is.

In reality, every time someone who came to the Costco before you made a purchase, the store owners moved the product a little bit closer to you, and manufacturers began shipping more variants of it.  The decisions that determined the composition of your commercial world were made over hundreds of years by individuals with no understanding of health – diet and exercise, hypertension and heat disease all being foreign concepts until recently.  Today potato chips, in all their variety, take up quite a lot of shelf space, and healthful foods are hard to come by.

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2/3 Petrie-Flom Health Law Workshop: Paper Now Available

Kevin Outterson will join us on Monday, February 3, for the first spring meeting of the Petrie-Flom Center’s Health Law Policy Workshop. He is a Professor of Law and Professor of Health Law, Bioethics, and Human Rights at Boston University. Professor Outterson teaches health law and corporate law, and his interests include global pharmaceutical markets, finance and organization of health care systems, antimicrobial resistance, poverty tourism, and health disparities. He serves as the editor-in-chief of the Journal of Law, Medicine & Ethics, the faculty co-advisor to the American Journal of Law & Medicine, the immediate past chair of the Section on Law, Medicine & Health Care of the AALS, and a member of the Board of the American Society of Law, Medicine & Ethics. Before teaching, Professor Outterson was a partner at two major U.S. law firms.

His research work focuses on the organization and finance of the health sector. Areas of specialization include global pharmaceutical markets, particularly antibiotics and other antimicrobials that can degrade in usefulness over time through resistance.

On Monday, Professor Outterson will discuss his paper “New Business Models for Sustainable Antiobiotics.” For more information on the Health Law Workshop, including meeting time and location, and to download the paper, please visit our website.

Encouraging Innovation in Chronic Care Management

By Michael Young

The growing burden of managing chronic illness has long been a critical issue for policy makers and clinicians seeking to improve the quality, cost and efficiency of healthcare systems in the United States. According to the Institute of Medicine, the costs of treating and managing the segment of the population living with chronic illnesses currently represents nearly $1.5 trillion of the over $2 trillion in annual healthcare spending in the U.S.  Over 90% of Medicare costs are allocated to beneficiaries living with two or more chronic conditions, with close to 50% of spending on individuals living with 6 or more chronic conditions (approximately 14% of beneficiaries).  The immense share of healthcare spending attributable to chronic illness is expected to climb as the population ages. 

Earlier this month, a bipartisan bill entitled the Better Care, Lower Cost Act was introduced in Congress which aims to address the complex issues involved in chronic care management.  The legislation outlines three key innovations toward this end.

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Managed Care for Mental Health

By Nathaniel Counts

Managed care and integration of primary care and mental health services are major foci of the Affordable Care Act, especially as more practices are encouraged to become Patient-Centered Medical Homes.  In managed care, vitals are used to track progress, and case managers can look over an individual’s blood pressure, weight, and blood-sugar levels to work with service providers and patients to ensure best outcomes.  If an individual is receiving mental health services, then the providers will share information about the patient’s current needs in both physical and mental health.  If the individual is not referred to or does not seek out mental health services, then there is no mental health component to manage.

Meanwhile in Massachusetts, every pediatrician is mandated to offer CANS (Child and Adolescent Needs and Strengths), a lengthy evaluation form that asks a patient (aged 5 to 20 for the link above) to evaluate their own life and mental health on sets of 0-3 scales.  CANS is used to monitor children’s mental wellbeing and identify potential problematic areas, including whether a mental health referral for serious emotional disturbance is necessary.  To the best of my knowledge, this information is not stored and used as an indicator for managed care, as blood pressure and weight are. Continue reading

New Blog, “ACA Death Spiral,” by Houston Law’s Seth Chandler

In case the title of the blog doesn’t make its thrust clear, here’s a snippet from Seth’s opening post:

This blog is going to chronicle what I believe will be the implosion of the Affordable Care Act.  I do not believe the Exchange based system of providing health insurance without medical underwriting is likely to work or that, if it does, it will not need far more massive propping up from federal taxes than is conventionally recognized. We’ll be looking at current events, the history of the Act, important court cases, and regulatory developments. Our tools will be a careful review of primary documents, some graphical and mathematical analyses, and references to important and insightful articles written by others.

Also, there is more to the Affordable Care Act than the Exchanges.  There is more than the individual mandate. There is the employer mandate, the complex systems of federal reinsurance needed to backstop the Act, the reintroduction of medical underwriting under the “wellness label” and so much more.  We’ll try as time permits to take a look at developments in these important areas too.

Seth — who is an insurance law expert — notes the “need for some hard and at least somewhat scientific look at what is going on.” So far, since beginning the blog some 48 hours ago, he has tackled the Upton Bill intended to address the “if you like your health care plan you can keep it” issue (which passed the House this afternoon with the help of 39 Democrats and now heads to the Senate); yesterday’s announced “Obamafix,” intended to address the same issue; whether the ACA’s little-known reinsurance and risk adjustment provisions could make exchanges more resilient to the underenrollment that many, including Seth, anticipate; and five questions journalists should be asking about the ACA (hint: fewer questions about how the rollout is likely to affect the careers of pols; more questions about the winners and losers under the ACA among the rest of us).

Welcome to the blawgosphere, Seth.

[Cross-posted at The Faculty Lounge]

Video Now Available: Tulsa Law Review Symposium Honoring Einer Elhauge

On Friday, October 4, the Tulsa Law Review hosted a symposium titled “Health Law Policy: Legal Issues in the Evolving Healthcare Market” honoring the work of Petrie-Flom Center Founding Director Einer ElhaugeI. Glenn Cohen, current Faculty Co-Director of the Petrie-Flom Center, and Christopher T. Robertson, Visiting Professor at Harvard Law School and former Petrie-Flom Academic Fellow spoke at the event.

For more information, including a link to the event videos, click here.

Another Wrinkle in Exchange Rollout? Private Sites Attempting to Lure Shoppers Looking for Exchanges

Yesterday saw two reports—perhaps the first of many—discussing the emergence of an additional wrinkle in the rollout of the health exchanges: private websites attempting to lure shoppers away from the government exchanges with websites that look and sound like the real thing.

According to an article posted by WMUR New Hampshire, the state insurance commissioner has issued a cease-and-desist letter to the owner of one website, newhampshirehealthexchange.com, that is allegedly trying to take advantage of shoppers hoping to acquire insurance through the real exchange.  New Hampshire’s not the only state dealing with this sort of issue.

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Call for Papers on “Buying and Selling Health Care”

The Journal of Law, Medicine & Ethics plans to publish a symposium issue in Winter 2014 exploring ethical, legal, and clinical issues triggered by the increasing commercialization of health care in the United States. The symposium will address a variety of dynamics present in this quintessentially American medical marketplace, with a particular focus on how commercialism impacts practitioners, patients, and policy makers at all levels.

Papers from any perspective or disciplinary background and concerning any aspect of the “buying and selling of health care” are welcome.

Deadlines and submission instructions below the fold.

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HHS Proposes Rule to Amend NOTA, Nullify Flynn v. Holder

On October 2, in the midst of the government shutdown—either HHS somehow managed to convince itself that the rule was “necessary for the protection of life” or, more likely, it had already been scheduled for printing—HHS quietly published a Notice of Proposed Rulemaking. The proposed rule would effectively moot the recent Ninth Circuit case of Flynn v. Holder by criminalizing the compensation of bone marrow donors, even when the life-saving stem cells are extracted through a newer, minimal risk procedure. In this post, I’ll explain the medicine, the Ninth Circuit’s decision, and what HHS proposes to do in response. In my next post, I’ll have some reaction to HHS’s policy arguments, about which I’m skeptical, and perhaps a few thoughts about where plaintiffs might go from here.

Section 301 of the National Organ Transplant Act (NOTA) of 1984 criminalizes the transfer of “human organs” for “valuable consideration.” Reimbursement of reasonable out-of-pocket expenses associated with travel and lost wages are okay—as are, since the 2008 amendment of NOTA, paired living donor chains—but any other “valuable consideration” that might incentivize sources of organs is not. Under NOTA, as amended,

‘human organ’ means the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin or any subpart thereof and any other human organ (or any subpart thereof, including that derived from a fetus) specified by the Secretary of Health and Human Services by regulation

(emphases added). HHS has since added to this list “intestine, including the esophagus, stomach, small and/or large intestine, or any portion of the gastrointestinal tract.”

So-called “bone marrow transplants”—in reality, infusions of hematopoietic (blood) stem cells (HSCs)—are often life-saving procedures for those with, for example, leukemia or aplastic anemia. (See these sobering statistics compiled by the Institute for Justice, which represented the plaintiffs in Flynn.) When NOTA was passed, the only way to obtain HSCs was through bone marrow aspiration using a long needle thick enough to suck liquid marrow directly from the donor’s pelvic bone. HSCs are then harvested from the marrow. The procedure is done under general anesthesia and so the donor is subject to the usual risks of anesthesia. Although the donor can return to usual activities in two to seven days, discomfort may linger for up to two weeks. Continue reading

The Spillover Effect of Medicare FFS on MA Negotiations

By Jeremy Kreisberg

The Congressional Budget Office (CBO) recently released an assessment of two illustrative versions of premium support for Medicare.  The report is interesting for many reasons, but I want to focus on one issue that Austin Frakt at The Incidental Economist raised.

Among the assumptions in the report, CBO “estimate[d] that in most counties the percentage of beneficiaries enrolled in the [Medicare Fee-For-Service (FFS)] program would decline once either premium support option took effect. . . . [T]he reduced market share of the FFS program would tend to boost the rates that private insurers paid to health care providers and thereby lead them to raise their bids” (pg. 39).

In a very thoughtful post, Professor Frakt questioned this assumption:

I read the details in the report that follow, but they didn’t help me with my fundamental objection. There’s a lot of verbiage about the (non-Medicare Advantage (MA)) commercial market paying higher prices than MA or FFS. The idea seems to be that Medicare private plans would tend to resemble the commercial market, if not for FFS. Hence, prices would go up if FFS became less of a threat, as it would under premium support.

This may be true, but not enough was said about why. The commercial market and the Medicare one serve different consumers, are challenged by different competitors, and are constrained by different regulations. They are different markets. Why should prices in one have any relation to those in the other?

I agree with Professor Frakt that there is no easy answer here, but I’m a bit more confident that CBO has a sound theoretical justification for its assumption.  After the jump, I’ll explain what I perceive as CBO’s theoretical justification, and I’ll note one interesting application of CBO’s reasoning to another controversial policy proposal.

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Anonymity is Not Privacy (and Why it Matters)

Anonymity is not just an aspect of privacy and recognizing their difference reveals a powerful and poorly understood set of legal tools for facilitating and controlling the production of public goods.  This is the central claim of my newest article (SSRN draft available here).

Three examples illustrate the scope of the under-explored ways in which anonymity is currently used in our law.

  • The first is from June 1997, when many residents in the Boston neighborhood of Allston learned to their anger that Harvard University had spent the previous 8 years secretly acquiring over 50 acres of Allston real estate.  It did so using buying agents, which can generally protect their principal’s anonymity—even by falsely stating that they are not agents.
  • The second is from Election Day 2012, when many voters who had shared photos of their completed ballots on Facebook and Twitter learned, to their surprise, that they had violated their states’ elections laws in doing so.   They did not know that anonymity in voting was not just a right, but also a requirement.
  • The third is from a 2006 lawsuit over the control of thousands of tissue samples being used in research at Washington University.  When many of the research participants sought to withdraw their tissue from future research, in response to what they saw as a breach of their consent, they were shocked to learn that the university could refuse and extinguish their rights of withdrawal by anonymizing their tissue samples.

These varied uses of anonymity in our law—as a right when purchasing land, a requirement in voting, and a trigger than extinguishes rights in biomedical research—may appear to be unrelated.  But I argue that they are in fact all part of a cohesive and previously unrecognized class of rules that use anonymity not to protect privacy, but rather to incentivize or control the production and circulation of information and other socially desirable goods. Continue reading

Racism in Transplant Denial? Or Too Few Hearts To Go Around?

Anthony Stokes, a fifteen year old kid from Decatur County, Georgia, is expected to die in a matter of months, according to his doctors at the Children’s Healthcare of Atlanta.  Maybe, they say, he will live for six months.  Who knows?  Anthony suffers from an enlarged, increasingly less functional heart.  His condition is not unusual, and a reasonably effective cure is at hand: a heart transplant. (Learn more about Anthony’s story here.)

However, Anthony has become the latest victim of a dysfunctional U.S. transplantation system, which tempts Americans with a transplant waiting list, but kicks them off if they become too sick or too old.  The problem is that there are too few organs to meet demand, and this perennial problem receives far too little attention from Congress.  Indeed, the U.S. transplantation list, coordinated by the United Network for Organ Sharing, UNOS, (a private organization that coordinates significant aspects of the U.S. transplant system) is so overcrowded that patients increasingly turn to black markets in India, China, Pakistan, South Africa, and other countries if they hope to survive.  (Learn more about that here.) Congressional hearings document Chinese prisoners dying and shortly thereafter Americans receiving organs.

Anthony’s family and some local organizations claim that racism is behind doctors refusing to place the boy on the transplant list.  Anthony is African American.  They ask, what is the harm in letting him on the list?

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The Tylenol Debate: Can Hospitals be Sued for Excessive Markups on Medications and Devices?

By Alex Stein

Steven Brill’s TIME MAGAZINE blockbuster article, Bitter Pill: Why Medical Bills are Killing Us, uncovers the CHARGEMASTER: a publicly undisclosed pricelist accountable for what we see in hospital bills. What we see there doesn’t look good: it includes acetaminophen sold for $1.50 a tablet (you can buy 100 of those for the same price at Amazon); $77 for a box of sterile gauze pads (Amazon’s prices vary between $6 and $11); $18 for a single diabetes test strip (sold for 54 cents by Amazon); $108 for antibacterial Bacitracin ointment (Amazon’s prices vary between $2.50 and $6.50); and so forth. Charges for stay, scans, surgeries, canes, and wheelchairs skyrocket as well.

The American Hospitals Association (AHA) rejects Brill’s analysis. According to AHA, the chargemaster aggregates the hospital’s overall costs on delivering quality care to patients: “In order to take medications in a hospital, even over-the-counter medicines, they must be prescribed by a doctor (a little bit of cost for the doctor), that order gets transmitted to the pharmacy (a little more cost), the order gets filled by a pharmacist or pharmacy tech who retrieves just one Tylenol pill and individually packages that one pill (still more cost), the pill gets transported from the pharmacy to the nursing unit where the patient resides (a little more cost), then the pill is retrieved by a registered nurse who personally gives the pill to the patient and then must document the administration of that pill in the patient medication administration record (a little more cost). All of this process to give a patient a single dose of Tylenol in a hospital bed [must also be] in compliance with all pertaining regulations (a little more cost).”

This post will not try to resolve the Tylenol Debate. Nor will it say anything about the government as a plausible substitute for the eccentric chargemaster. Instead, I will raise a legal question: Can patients sue hospitals for excessive markups on medications and devices?

My answer to this question is a qualified YES. Entrepreneurial and business aspects of running a hospital fall under states’ consumer protection laws (Brookins v. Mote, 292 P.3d 347 (Mont. 2012)). Those aspects certainly include billing (Jaramillo v. Morris, 750 P.2d 1301, 1304 (Wash. App. 1988); Ambach v. French, 216 P.3d 405 (Wash. 2009)). The key question here is whether an excessive markup on medications and devices amounts to deceit or an unfair trade practice. If it does, the hospital would be in violation of the relevant state consumer protection law. This might happen to hospitals whose billing practices—to which patients gave no informed consent—are particularly aggressive. Those hospitals might face class action suits and the prospect of paying treble damages. They also may be stripped of the special protections given to defendants in medical malpractice suits (that include shortened limitations and repose periods for filing suits, caps on damages, and charitable immunities). For my account of the competition between medical malpractice and consumer protection rules, click here.

Brill and other participants in the Tylenol Debate call on the government to start regulating hospital prices. My short advice to hospitals: get rid of unconscionable markups forthwith.

Transplant Tourism: Hard Questions Posed by the International and Illicit Market for Kidneys, New Article I Wrote

[Cross-Posted at Prawfsblawg]

The Journal of Law, Medicine, and Ethics has just published an article by me on transplant tourism, that discusses the burgeoning international market for buying and selling kidneys. I review the existing data from Pakistan, Bangladesh, and India, which is pretty deplorable. As I show the vast majority of these sellers are poor and using the money (which is a significnat sum in terms of what they earn, even though in the end only 2/3 is paid) to try to buy themselves out of bonded labor, pay off familial debts, or try to mount a dowry. Many are misinformed or decieved about the health consequences for them and the needs of the person who will receive their kidney. Once they have agreed to sell they are often pressured not to renege. They are often released too soon post-transplant compared to what is optimal for a transplant, and their self-reported health post-transplant is worse. Many experience significant social stigma as a “kidney man” (or woman)and the 20-inch scar (the more expensive way of doing the procedure would reduce the scar size) marks them for life and makes it difficult for them to marry. Most express significant regret and would advise others not to undertake the operation.

Despite these grave facts, as I argue in the paper (and in greater depth for many of these arguments in the chapter on transplant tourism in my new book on medical tourism under contract at Oxford University Press), many of the traditional justifications from the anti-commodification literature — arguments relating to corruption, crowding out, coercion, and exploitation — do not make a convincing case in favor of criminalization. If a ban is justified, I argue the strongest arguments are actually about defects in consent and justified paternalism, on the assumption that criminal prohibition is a second best regulation in the face of the impossibility of a more thoroughly regulated market.

I then examine what means might be used to try to crack down on the market if we concluded we should. I evaluate possibilities including extraterritorial criminalization, professional self-regulation, home country insurance reimbursement reform, international criminal law, and of course better organ retrieval in the patient’s home country.

I will keep writing on this topic, including for my new book, so even though this paper is done feel free to email me your thoughts.

The High Cost of Health Care: Why Some Pay $240 for a $9 Bottle of Pills

By Jonathan J. Darrow

An earlier post discussed the equivocal efficacy of Propecia (finasteride) as a baldness remedy, ending with the provocative assertion that, efficacy aside, “there is little reason for anyone ever to buy or consume Propecia (finasteride), or any doctor ever to prescribe it, since a much cheaper and identical chemical sold under the trade name Proscar (finasteride), is available.” This post continues the discussion, addressing one small component of the rising cost of healthcare—the cost of finasteride.  It explores why consumers pay as much as $240 for a bottle of Propecia (finasteride) when a $9 bottle of an equivalent, FDA-approved supply of the identical chemical is readily and legally available at nearby stores.

In the exorbitantly priced landscape of prescription drugs, there is at least one low-cost oasis: Wal*Mart.  Though some find reason to criticize the discount store, few would disapprove of the dozens of prescription medications Wal*Mart offers for an unbeatable $4 for a 30-day supply.  Cost-sensitive consumers can purchase everything from blood thinners to antidepressants to antibiotics at this price, while a 90-day supply is only $10 (and this price includes shipping to your doorstep).  A handful of drugs that cannot be sold at $4 per month sell for a still-modest $9.  For the 300 or so drugs on Wal*Mart’s list, this means there is no longer a need for $10 co-pays or snowy treks to the pharmacy in 15 degree weather.  That’s right: the Wal*Mart total price is less than most insurance company co-pays.  Finally, a major industry player seems to have put effective downward pressure on prescription drug prices.  Continue reading

Is Health Law the Problem Underlying the Physician Shortage?

This week, the New York Times Sunday Review has an editorial arguing that the shortage of primary care physicians could be reduced if we drew more heavily upon other professions, including pharmacists and nurse practitioners, who may be able to provide care more efficiently.  The Affordable Care Act’s efforts to increase insurance coverage and eliminate cost-sharing for preventative care, will only exacerbate the shortage of primary care physicians.  More to the point, the editorial alleges that various state and federal laws create barriers to the sort of integration of healthcare professionals to address the shortage.

Those “scope of practice” laws were enacted to either protect consumers from incompetent healthcare or protect physicians from competition in the healthcare marketplace, or likely some mixture of both.  We know where mainstream physicians stand anyway.  In the words of the American Medical Association’s own newsletter,  ”physicians [have] fought a blitz of scope-of-practice expansions by other health professionals on legislative, legal and regulatory fronts.”

The shortage of physicians is also a product of the number of young doctors that our medical schools are producing.  Although several new schools have launched in recent years, others are have actually shrunk due to budget cuts.

Twitter Round-Up (12/9-12/15)

By Casey Thomson
This week’s round-up looks at the problems of substandard drug prevalence abroad, NIH’s possible push for an anonymous grant-awarding process, and the Liverpool Care Pathway investigation. Check it out below!
  • Dan Vorhaus (@genomicslawyer) included a link to a report on the recent launch of Personal Genome Launch Canada. The post includes links to help navigate the content and learn more about the intricacies of this project. (12/9)
  • Frank Pasquale (@FrankPasquale) shared a post on the benefits and detriments of raising the age of Medicare eligibility from age 65 to 67 – an idea that has recently gained sway in the political arena. The author ultimately concludes that the move would only be a matter of cost shifting rather than cost saving, and thus harm the disenfranchised 65-66 year-olds that would front the cost. (12/10)
  • Frank Pasquale (@FrankPasquale) also included this article on Dr. Oz’s wrongful diagnosis on organics. While concerns about finances must indeed be taken into consideration when families decide what foods to purchase, families must also be concerned about the presence of pesticides in their food. Organic food, while more expensive, avoids this health hazard. (12/10)
  • Frank Pasquale (@FrankPasquale) additionally linked to this report on the preponderance of substandard (and oftentimes, consequentially lethal) drugs particularly in emerging markets. Efforts to crackdown on substandard drugs have thus far focused largely on counterfeit drugs, rather than those that are the result of “shoddy manufacturing and handling…or deliberate corner cutting,” which constitute an arguably much greater public health threat. (12/10)
  • Daniel Goldberg (@prof_goldberg) shared this post on the prevalence of worthless clinical practice guidelines. The article notes the need to distinguish the guidelines that meet much of the Institute of Medicine (IOM) quality criteria from the rest. (12/10)
  • Alex Smith (@AlexSmithMD) linked to a blog post on advance care planning and the gap between the needs of the healthcare system and those of patients. Currently, much of the paperwork required for advance directives is given without providing families and patients concrete skills needed for both identifying their desires and communicating such desires to direct their own medical care. This article calls for refocusing on providing direct patient empowerment in addition to the existing efforts to improve clinician communication in order to facilitate the ability of advance care planning to reflect the patient’s wishes. (12/11)
  • Michelle Meyer (@MichelleNMeyer) retweeted an article about the NIH’s consideration of introducing anonymity into the grant-awarding process in order to alleviate some of the concerns with bias that have long-plagued the agency. (12/12)
  • Dan Vorhaus (@genomicslawyer) also posted a report on BGI, a world-leading DNA sequencing organization based in China, and their commercial expansion efforts into the healthcare, agriculture, and aquaculture sectors. The question of whether BGI is more a research institute or commercial enterprise comes into question in the article. (12/12)
  • Stephen Latham (@StephenLatham) included a link to his own blog post on the recently renewed controversy concerning the Liverpool Care Pathway for the Dying Patient (LCP), particularly as to whether patients put on the LCP had a discussion with their care providers prior to the decision and whether hospitals were wrongly putting patients on the pathway. The talk of scandal sparked an independent investigation into the LCP; Latham’s article expressed his hope for thoroughness in the investigation and for serious consideration on how to renew the LCP effectively. (12/12)
  • Arthur Caplan (@ArthurCaplan) posted a link concerning the implications of 23andMe, a personalized genomics company, and their launch of the $99 genetic test in the hopes of inspiring greater numbers to get tested. The article’s author reflects on how the real benefit will likely not be immediate for individuals, but will rather depend on the chance that greater data will lead to more breakthroughs in understanding the human genome. (12/14)

Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.