Halbig and the Stability of the ACA

By Jeremy Kreisberg

I have previously blogged about an important case — Halbig v. Sebelius — before the U.S. District Court for the District of Columbia (DDC).  The case concerned whether the Affordable Care Act permits the IRS to issue tax credits to individuals purchasing insurance through federally facilitated exchanges.  In short, the challengers argued that because section 1401 of the ACA calculates tax credits only for individuals purchasing insurance through “an Exchange established by the State,” individuals purchasing insurance through an exchange established by the federal government cannot receive such tax credits.

Yesterday, DDC sharply rejected this argument, finding that the ACA — read as a coherent whole – requires the IRS to issue tax credits to individuals purchasing insurance through either a state or a federal exchange.  Needless to say, this case represents a triumph for the government.  For now (cases on the same issue are still pending in other districts, and this opinion will almost certainly be appealed to the D.C. Circuit), the government has dodged today’s biggest threat to the vitality of the ACA.

The substance of the case was summarized well by Professor Bagley over at the Incidental Economist.  So rather than dwell on the (very persuasive) reasoning of the court, I want to focus on one important doctrinal move in the case (after the jump):

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A Tale of Two Polities

By Scott Burris

Last week, Northeastern University’s effort to convene a much-needed conference on the future of health policy was a casualty of the successful manhunt for the Boston Marathon bombers.  One hardly wants to make too much of a stymied conference given all the human damage of the bombing and its aftermath, but all of us who had gathered for the meeting regretted that we would not hear from the panelists, and sympathized with organizers who had put so much into planning it.  In recognition of that, I am summarizing here what I planned to say there.  It is a tale of two polities that seem to compete for existence in our perceptions of the politics of public health.

One public health is incredibly popular with citizens and lawmakers alike – demonstrated by polling and passage of legislation.  I’ve recently blogged on this here.  The other public health is the despised nanny state, big government, the sequestered and slashed-to-the bone struggling provider of essential services that don’t get no respect and don’t deserve the meager tax dollars we still pay in. We see this in budget cuts, in hyperbolic allegations of “corruption,” and in disingenuous advocacy for a radical caveat emptor regime for all legal products.

What do we make of these two radically different views of where public health now stands in the public’s regard? My claim is that the former is largely the truth – public health is popular, not despised – but the latter view is what is driving budgets and a lot of policy. The action points follow: a sustained fight to mobilize public support and win more battles over budgets and laws. I see three main strands of work:

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Further On the Fake Anti-Government Electorate

By Scott Burris

In recent posts, I have been pointing to research that suggests that government intervention for public health is actually rather popular as a general matter. Now comes a neat paper that takes on the question of whether politicians actually know what their constituents want.  I read it as further evidence that our politics is being shaped by a lot of well-supported anti-government noise-making that has been allowed to flourish unchallenged.

The paper in brief: the authors surveyed candidates for state-level legislative office, and used a technique called multi-level regression and post-stratification (MRP) to localize opinion poll data to legislative districts. They then compared what candidates think their constituencies believe on key issues (health care reform, gay marriage, welfare reform) with what the polls say their constituents believe.  They find that both conservatives and liberals significantly overestimate the conservatism of the people who elect them:

In districts where supporters of these policies outnumber opponents by 2 to 1, liberal politicians appear to typically believe these policies enjoy only bare majority support while conservative politicians typically outright reject the notion that these policies command widespread support.”

The paper is worth reading for its findings (and to allow you to personally assess its limitations – this has not yet even been peer reviewed.) A more detailed summary with some of the charts is on Dylan Matthew’s Washington Post blog.

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Overspent: Inauguration Day Thoughts on the Future of Health Policy

By Cassie Chambers

In honor of today’s presidential inauguration, I started making a list of exciting past, present, and future health policies advocated by the Obama administration. Thirty minutes later there was still just one word on my computer screen: OBAMACARE. Then, I came to terms with what the next four years represent for health policy: an empty page in healthcare history, colored only by the shadow of the Obamacare fight. In short: we’ve spent all of our health policy political capital, and the next few years are all about paying off the bill.

I could perhaps accept this bleak vision of the future if I thought that the Affordable Care Act had provided solid solutions to our current problems. But the compromises needed to pass the ACA left it littered with holes—including a lack of effective cost-controls that threatens to undermine the entire system. Because of these holes, there is one more truth we have to face: however expensive Obamacare was initially, we still haven’t paid the full price.

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Dreams Deferred

After the November election, President Obama’s executive order implementing parts of the so-called “Dream Act” was widely credited with shoring up his support within the Latino community.  Less often noted was his Administration’s decision to exclude the “Dreamers” from the benefits afforded by the Affordable Care Act.

Last August, the Center for Medicare Services (CMS) issued an interim final regulation stating that individuals who benefitted from the President’s program, more formally known as “Deferred Action for Childhood Arrivals” or DACA, would not be considered “lawfully present” for purposes of eligibility to health benefits established by the Affordable Care Act, including the Pre-Existing Condition Insurance Plan and the subsidies and credits that will be available in 2014 to purchase insurance through the health insurance exchanges. Pre-Existing Condition Insurance Plan Program, 77 Fed. Reg. 52614-01 (Aug. 30, 2012) (to be codified 45 C.F.R. § 152.2), http://www.gpo.gov/fdsys/pkg/FR-2012-08-30/html/2012-21519.htm.

The impact of this little noticed determination is quite significant. Although most of the estimated 1.7 million DACA immigrants are healthy, because of their age (under 30), many lack access to employer-provided health insurance. Moreover, if as expected, employers begin to shift their health insurance programs to the ACA-created exchanges, DACA immigrants may find themselves barred from employer-provided plans, even though under the President’s executive order they have a legal right to work in the United States.

The insurance gap created by CMS’ determination that the DACA immigrants are not “lawfully present” in the U.S., a decision that is inconsistent with the Administration’s conclusion that other deferred action recipients are eligible for benefits established under the ACA, illuminates the critical relationship between immigration policy and health policy.  To a surprising degree, the health insurance access problem in the U.S. results from laws that bar immigrants (including many with Green Cards) from many government-supported health insurance programs, including Medicaid. In 2010, over 45 % of non-citizens were uninsured, as compared to less than 14 % of native-born Americans. Approximately 65 % of undocumented immigrants are believed to lack health insurance. The ACA is unlikely to reduce those rates, especially regarding undocumented immigrants. Neither, it is now seems, is DACA.

Roundup of State Ballot Initiatives on Health Issues

By Katie Booth

This November, voters weighed in on an array of state ballot initiatives on health issues from medical marijuana to health care reform. Ballot outcomes by state are listed below (more after the jump).

Voters in Alabama, Montana, and Wyoming passed initiatives expressing disapproval of the Affordable Care Act, while a similar initiative in Florida garnered a majority of the vote but failed to pass under the state’s supermajority voting requirement. Missouri voters passed a ballot initiative prohibiting the state executive branch from establishing a health insurance exchange, leaving this task to the federal government or state legislature. Florida voters defeated a measure that would have prohibited the use of state funds for abortions, while Montana voters passed a parental notification requirement for minors seeking abortions (with a judicial waiver provision). Perhaps surprisingly, California voters failed to pass a law requiring mandatory labeling of genetically engineered food. Several states legalized medical marijuana, while Arkansas voters struck down a medical marijuana initiative and Montana voters made existing medical marijuana laws more restrictive. Colorado and Washington legalized all marijuana use, while a similar measure failed in Oregon. Physician-assisted suicide was barely defeated in Massachusetts (51% to 49%), while North Dakotans banned smoking in indoor workplaces. Michigan voters failed to pass an initiative increasing the regulation of home health workers, while Louisiana voters prohibited the appropriation of state Medicaid trust funds for other purposes.

Affordable Care Act:

  • Alabama Health Care Amendment, Amendment 6: Approved 59.52% to 40.48% (prohibits mandatory participation in any health care system)
  • Florida Health Care Amendment, Amendment 1: Defeated 51.46% to 48.54% (required 60% support to pass) (would have prohibited passing laws compelling the purchase of health insurance)
  • Missouri Health Care Exchange Question, Proposition E: Approved 61.8% to 38.2% (“prohibit[s] the Governor or any state agency, from establishing or operating state-based health insurance exchanges unless authorized by a vote of the people or the legislature”)
  • Montana Health Care Measure, LR-122: Approved 66.83% to 33.17% (prohibits “the state or federal government from mandating the purchase of health insurance coverage or imposing penalties for decisions related to the purchase of health insurance coverage”)
  • Wyoming Health Care Amendment, Amendment A: Approved 76.98% to 23.02% (stating that “the right to make health care decisions is reserved to the citizens of the state of Wyoming”)

Drug Law Factoids for Your Consideration

By Scott Burris

This is a succinct paragraph from the weekly newsletter of U. Maryland’s Center for Substance Abuse Research. Seems relevant both to the conference on law  enforcement and public health I reported on earlier this week, and the election results on marijuana:

There were an estimated 12,408,899 arrests in the United States in 2011, according to data from the national Uniform Crime Reporting (UCR) Program. The highest number of arrests were for drug abuse violations—selling, manufacturing, or possessing drugs, followed by larceny-theft and driving under the influence. The majority (82%) of these arrests were for possession and one-half of these drug abuse violations involved marijuana. A poll conducted in 2011 found that one-half of U.S. residents think that marijuana should be legalized (see CESAR FAX, Volume 21, Issue 19).

Twitter Round-Up (11/4-11/10)

By Casey Thomson

[Ed. Note. 11/12/12: Just to be clear, retweeting should not be read as an endorsement of or agreement with the content of the original tweet.]

With Election Day now come and gone, our bloggers were tweeting this week about the results, in addition to the greater happenings in health law and ethics. Read below for this week’s round-up:

  • Arthur Caplan (@ArthurCaplan) retweeted a post about the recent clinical trial done on chelation, a “fringe” heart disease treatment whose popularity often hinges on a patient’s distrust of conventional medicine. Evidence of the treatment’s effectiveness looks to be marginal, at best. (11/4)
  • Michelle Meyer (@MichelleNMeyer) retweeted an article that explained the problems in the intersection between neuroscience and law, namely how emerging technologies in neuroscience are not being used appropriately to understand criminal behavior. The author advocates for a renewed look at how neuroscience and law can work together, not only to evaluate defendants effectively, but also to customize plans that can serve the interests of both the defendant and the public. (11/5)
  • Dan Vorhaus (@genomicslawyer) linked to a new piece he co-authored on clinical data and genetics, entitled “The Next Controversy in Genetic Testing: Clinical Data as Trade Secrets?” (11/6)
  • Michelle Meyer (@MichelleNMeyer) aptly summarized the results of Massachusetts’ ballot questions with her tweet: “Sick folk in MA can now smoke pot but, it seems likely, not have the aid of their doc in controlling the timing & nature of their death.” (11/6)
  • Daniel Goldberg (@prof_goldberg) linked to a study done on children with epilepsy  and their families. Goldberg noted that the study’s results indicate a serious “ethically pernicious” problem that in fact worsens the condition of those afflicted with epilepsy more so than may be originally perceived: stigmatization. (11/7)
  • Frank Pasquale (@FrankPasquale) tweeted a blog post that talked of the need to increase the FDA’s power in order to curb the fungal meningitis outbreak now affecting individuals nationwide. Lamentations of the state-based system’s inability to handle the problem had undertones of concern for future situations similar to this one sprouting up again. (11/8)
  • Frank Pasquale (@FrankPasquale) also published a news update from Georgia, where legislators are ending the discount on license renewal prices that had previously been given to motorists who signed up to be organ donors. While many expressed fear that the policy would decrease the number of donors, others in the medical community admitted that there had been no demonstrated link between the policy and increases in donor sign-ups. (11/10)

Bill of Health Interview with Einer Elhauge on Health Care Reform

As you have already heard a few times on this blog, Professor Einer Elhauge, the Petrie-Flom Center’s Founding Faculty Director and Petrie Professor of Law at Harvard Law School, has a new book out on health care reform called Obamacare on Trial.  The book collects various essays that Prof. Elhauge published in popular media outlets, along with several postscripts, and it has received all sorts of glowing praise.

Prof. Elhauge has graciously agreed to answer some questions for us in the first ever Bill of Health e-interview.  Check it out:

Bill of Health: So, first things first, did the Supreme Court get it right in NFIB v. Sebelius?

Prof. Elhauge: The Supreme Court got the tax issue right, and I think the Medicaid expansion as well, but I think the Supreme Court got the commerce clause issue totally wrong.  Worse, the way they got it wrong portends trouble for the future.

Bill of Health: What were you most surprised by in the SCOTUS decision?

Prof. Elhauge: The fact that a majority of the Supreme Court was willing to use a methodology that clearly expanded judicial discretion to overrule the political branches, and that no one really ever called them on it either on the Supreme Court or in the briefing.

Bill of Health: You’ve noted that you didn’t originally take the constitutional challenges to the Affordable Care Act seriously.  Why do you think they were able to gain such traction?

Prof. Elhauge: I think the big problem was that the government never directly rebutted either the claim that purchase mandates were unprecedented or the dreaded broccoli hypothetical.  Instead they tried to evade the question, I guess because they thought it was unfavorable to them, but the iron rule of litigation is that if you don’t discuss your problematic issues, then you leave your opponents to be the only one that discusses them, and they are sure to frame them in the way most unfavorable to you. The government’s unwillingness to engage this issue left the Supreme Court with the entirely false impression that Obamacare fundamentally changed the relationship between the individual and government, and that thus the government faced a heavy burden to justify the health insurance mandate.  I think the government should’ve directly argued that in fact federal purchase mandates were not at all unprecedented, but rather that health insurance mandates went all the way back to the framers, who adopted two health insurance mandates in the 1790s in Congresses that had many framers on them.  The government should’ve also pointed out that the argument that courts can, in the name of “limiting principles”, create brand-new restrictions on congressional power that have no basis in the Constitution in order to restrain the possibility that Congress might exercise a power in a silly way, like adopting a broccoli mandate, amounts to a remarkable usurpation of political power by the judicial branches.  One could equally say that because Congress might pass silly laws like a law prohibiting the purchase of broccoli, the federal courts should impose a new constitutional limit that prevents Congress from ever restricting commerce. Or because Congress might tax 100% of our income to buy broccoli or go to war to get more broccoli, the Supreme Court should invalidate Congress’s power to tax or declare war.  The “limiting principles” argument that was employed here ironically has no limiting principle and looks benign but is actually a wolf in sheep’s clothing.

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The Contraceptives Coverage Saga Continues…

Well, hopefully we’ll know the fate of the ACA by tonight.  But even if President Obama wins, there will still be uncertainty about the fate of the contraceptives coverage mandate.

A number of employers claim that the mandate violates their rights to religious freedom by requiring them to offer free coverage for medical products and services they find objectionable, and the administration has taken a number of steps to offer accommodations.  But as a neutral law of general applicability, the mandate doesn’t violate the First Amendment under SCOTUS jurisprudence, and even under the Religious Freedom Restoration Act, there’s a strong argument that the mandate is ok, either on the grounds that it does not actually impose a substantial burden on religious exercise or that  it is supported by a compelling government interest.

Nonetheless, federal courts have reached different conclusions as to the mandate’s permissibility.  In July, a federal district judge in Colorado issued a preliminary injunction blocking enforcement of the mandate against a religious employer running a secular (HVAC) business, while in September, a federal district judge in St. Louis rejected a similar challenge by the religious owner of a mining company.  Last week, a federal district judge in Detroit also issued a preliminary injunction against enforcement, indicating that while neither side had shown a strong likelihood of success on the merits, “The loss of First Amendment freedoms, for even minimal periods of time, unquestionably constitutes irreparable injury.”  Several other challenges to the mandate remain pending.

So let’s just add this to the list of uncertainties that will remain after the results of today’s election are in – and to the list of reasons why employer-based health care really ought to be abandoned in favor of a single-payer, public system.

There, now that ought to get some discussion started…

Bending the Cost Curve, Not Just Talking About It

By Nicolas Terry

When the 2012 history of health care is written, which date will have the largest entry, November 5 or 6? Of course, many (but not that many) provisions of the Affordable Care Act will live or die depending on how the election affects control of the White House and Senate. But, November 5 may end up having more significance because that is the date Massachusetts’s new health care spending legislation, here, takes effect.

Signed into law by Governor Patrick on August 6, 2012, the new law now has its own website, here, the promise of a a ton of data, here, and in Brandeis University economist Stuart Altman, here, a chair for its Health Policy Commission (HPC).

Thomas Lee, here, notes “the 349-page law that was just passed in Massachusetts created 25 new boards, task forces, and commissions, and 266 new appointees are going to be enlisted to monitor and enforce compliance with spending caps, oversee provider performance improvement plans, and certify Accountable Care Organizations (ACOs).”

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Art Caplan: MA Should Legalize Physician-Assisted Suicide

Weighing in on Question 2, Massachusetts’ ballot initiative on physician-assisted suicide, Art Caplan says we should vote “yes”:

Mass. should legalize physician-assisted suicide

Of the numerous ballot initiatives that will be decided at the state level on Tuesday, none is more hotly contested than the Massachusetts bill to decide whether to legalize physician-assisted suicide. The citizens of Massachusetts, my home state, should vote to legalize.

The proposed measure allows terminally ill patients to be given access to lethal drugs. A terminally ill patient is defined as someone with six months or less to live. The patient’s terminal diagnosis and mental competency must be attested to by two doctors. Patients would have to make a request to their doctor twice orally and once in writing. The written request would have to be witnessed.

Yet even with such restrictive conditions, opponents of the proposal say doctors should never, as a matter of professional ethics, intentionally hasten the death of one of their patients, even one who is terminally ill. The codes of medicine and nursing ethics reject helping patients die.

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Politics in Practice: Intense Conversations in Intensive Care

By Erin Talati

As Holly Lynch describes in her recent post, the upcoming election brings a number of bioethics questions directly to the public. Two of the three ballot questions in Massachusetts invite discussion and debate on the controversial issues of physician-assisted suicide and the medical use of marijuana. The introduction of these issues as ballot initiatives offers physicians the opportunity for rich discussion on important topics with their patients. But, how much should physicians and other health care providers share with patients regarding their own views on these issues?
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TOMORROW: Einer Elhauge’s Obamacare on Trial – Book Talk and Panel Discussion

Obamacare on Trial

Book talk and panel discussion by Einer Elhauge, Carroll and Milton Petrie Professor of Law, Harvard Law School (and founding director of the Petrie-Flom Center)

Panelists:

Thursday, Nov. 1, 2012, 6:00 pm

Wasserstein Hall, Milstein East A

Harvard Law School

1585 Mass Ave, Cambridge, MA

Sponsored by the Harvard Law School Library

Physician-Assisted Suicide in MA

Next Tuesday, those of us registered in Massachusetts will have the opportunity to vote on “Question 2″ – prescribing medication to end life, otherwise known as physician-assisted suicide.  As described by the state secretary, “This proposed law would allow a physician licensed in Massachusetts to prescribe medication, at a terminally ill patient’s request, to end that patient’s life. To qualify, a patient would have to be an adult resident who (1) is medically determined to be mentally capable of making and communicating health care decisions; (2) has been diagnosed by attending and consulting physicians as having an incurable, irreversible disease that will, within reasonable medical judgment, cause death within six months; and (3) voluntarily expresses a wish to die and has made an informed decision.”  There are, of course, a number of other safeguards built in, such as the need to make the request twice, separated by 15 days, in the presence of witnesses.  However, there could probably be stronger safeguards to protect individuals who are experiencing depression and anxiety, and might have preferable alternatives to physician-assisted death.

The proposed law is similar to measures already in place in Oregon and Washington state, where statistics show relatively low uptake and certainly not the sort of slippery slope that critics seem to be worried about.  In today’s NY Times, however, Zeke Emanuel describes 4 myths about physician-assisted suicide that might give some pause to people like me who plan to vote “Yes” on Question 2.  In the end, though, it strikes me that preserving room for maximal choice in these difficult end-of-life situations is for the best.

Without delving into the merits, which has been done very well elsewhere, let me just make a quick note about something else that struck me re: Question 2, which was the pamphlet of materials I received at home about the ballot measure.  It came from the state secretary, had an excellent, understandable summary of the law and what it would do, and included brief statements for and against written by selected advocates.  I thought this was an incredible mechanism to promote informed voting and deliberative democracy – and because I always have human subjects research ethics on the brain, it made me think of the possible ways this approach could be adapted to improve informed consent.  Perhaps traditional consent forms could be accompanied by a brief neutral statement about a study from the IRB, followed by short statements pro and con about the decision to participate. Just a thought.

And finally, one more note: we’re having a bioethics-heavy election day in Massachusetts this year.  Question 3 is about whether we should eliminate state criminal and civil penalties for the medical use of marijuana by qualifying patients.

 

Is a Move Towards Freezing Oocytes a Move Towards Less Legal Liability for IVF Clinics? — Reflections from ASRM Annual Meeting Round 1

It was an exciting time to attend the annual meeting of the American Society for Reproductive Medicine in San Diego this week.  Just before the meeting, ASRM reclassified cryopreservation of oocytes for future use, removing the procedure’s “experimental” label. The possibility of increased uptake of this procedure raises many ethical issues (some of which I hope to discuss in a later post), but it also presents the potential to sidestep a number of legal liabilities and ethical issues associated with frozen embryos which are not implicated by frozen gametes. This begs the question: Is a move towards egg freezing in lieu of freezing embyos a safeguard against some types of liability for IVF clinics?  I think this may be the case.

Perhaps most importantly, frozen oocytes will not implicate personhood laws.  Advocates of personhood laws, such as vice presidential candidate Paul Ryan, have come under fire by pro-choice and feminist groups for their attempts to ascribe legal rights to embryos and fetuses.  However,  IVF clinics and clinicians should also be concerned.  It is an unanswered legal question if an IVF clinician or embryologist could be found guilty of manslaughter if there was an accidental thaw of a cryotank full of embryos.  There have been no such criminal proceedings brought against an IVF clinic — yet.  Freezing eggs would guard IVF clinics in states with personhood laws from this kind of criminal liability. Another question implicated by personhood laws is whether there is a doctor-patient relationship between a newly-created or frozen embryo. If one exists, then negligence claims regarding proper storage of embryos could become medical malpractice claims; if frozen gametes are mishandled it is unlikely such a relationship could exist.  Litigation against the Oschner Fertility Clinic (which has now closed) brings some of these issues to life.

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Sherley v. Sebelius and the Future of Stem Cell Research

Glenn Cohen, and his co-authors Jeremy Feigenbaum and Eli Adashi, have a new piece out in JAMA today, Sherley v. Sebelius and the Future of Stem Cell Research.  Here’s a brief excerpt:

While enactment of “personhood” bills would constitute the most significant threat to hESC research, the outcome of the 2012 presidential election will also play a large role in where the science goes. Should President Obama be reelected, the status quo will in all likelihood be maintained. Much less is known as to policies that might be pursued by a potential Romney Administration. Still, former Governor Romney is on record opposing the proposition of creating a human embryo through “cloning” or “farming” for the sole purpose of research, ie, “when the sole purpose of its creation is its sure destruction.” Romney is also on record in support of a constitutional amendment that establishes life as beginning at conception. All told, these positions, seconded by Congressman Paul D. Ryan (R, Wisconsin), the Republican vice presidential candidate, and echoed by the Republican Party platform, could substantially alter the prospects of hESC research.

Apart from the aforementioned considerations, the future success of stem cell research cannot be ensured absent the following provisions. First, the derivation of hESC cell lines, especially disease-specific lineages, must proceed apace. Such in vitro models permit a detailed interrogation of the molecular pathology of recalcitrant maladies, allow for the identification of druggable targets, and enable the testing of candidate therapies. Policies intent on limiting publicly funded hESC research to existing cell lines—as advocated by former President George W. Bush—run the risk of curbing progress while shifting the onus of underwriting to the private sector. Second, hESC lines, the current gold (if ideologically contentious) standard, cannot as yet be replaced by the (ideologically more neutral) human-induced pluripotent stem cell (hiPSC) lines of adult origin. Indeed, the molecular signatures and the safety profile of current hiPSC lines are sufficiently distinct from those of hESC provenance so as to qualify their imminent application in the clinical arena. Policies designed to favor hiPSC research—as espoused by Romney—may prove premature and unduly proscriptive.

Take a look at the whole Perspectives piece here.