Category: Health Law Policy

Home HIV Testing, partner screening, the medicalization of intimacy, and responsibility for health

I. Glenn Cohen Leave a comment

As the New York Times reported this week, in an article entitled “Another Use for Rapid Home H.I.V. Test: Screening Sexual Partners,” some in the public health community are exploring the ramifications for a use of the new OraQuick home HIV test that the company has been somewhat coy about: using it to test a new partner before sex, which may be particularly likely in the gay community. On November 5, 2012, the Petrie-Flom Center (in collaboration with Fenway Institute and Center for Health Law and Policy Innovation) will be hosting a great live panel (open to the public) “Advances in HIV Prevention: Legal, Clinical, and Public Health Issues,” focused in part on the OraQuick test and also on Pre-Exposure Prophylaxis (Truvada). The event will also be webcast after the fact.

Unfortunately, I’ll be in Malaysia touring hospitals as part of the research on my new book on medical tourism during the event, but I thought I’d use this forum to share some of my thoughts/questions about the use of these tests for partner screening. Here they are in a few different boxes:

The Medicalization of Intimacy: Is there something problematic about intimate sexual conduct becoming a medicalized affair to some extent? We are not all the way to the scene in Gattaca where Uma Thurman plucks a hair from Ethan Hawke to genetically profile him before deciding whether to pursue him romantically, but this use of OraQuick does interpose a medical technology into a sexual relationship. Now there may (more on that below) be public health benefits such that the development is all-things-considered for the best, but is something lost when this happens? Perhaps a separate spheres concern when technology is used to replace trust/intimacy? Or is this overblown? How will this affect the personal lives of individuals with HIV, and is that relevant?

Overreliance and the Effect on other STIs: The Times Article suggests that the designers of the test have made a specific choice as to Type 1 v. Type 2 errors: “It is nearly 100 percent accurate when it indicates that someone is not infected and, in fact, is not. But it is only about 93 percent accurate when it says that someone is not infected and the person actually does have the virus, though the body is not yet producing the antibodies that the test detects.” Will individuals who do partner screening internalize these numbers or will they go right from a negative test to no condom use, not processing the 7% risk the test is incorrect? Moreover, even if correct, will the test lead to (a) internalization of poor sexual health practices (no condoms) that users will carry over to encounters where they do not use the test, and/or (b) the spreading of non-HIV STIs like gonorrhea (the New Yorker recently gave a terrifying account of the rise of antibiotic-resistant gonorrhea)? What is the tort liability for the company in one of these situations, if any? If we think some individuals will be bad decision-makers and put themselves at greater risk for non-HIV STIs (not saying the data is there, just asking “what if” or the sake of argument) should that be relevant as to whether such tests should be available/approved? Do the numbers matter? Or is it the case that if even one person might avoid an HIV infection that would outweigh, from a policy perspective, an increase in other STIs of a large size? Those who have followed my writing and blogging on health care rationing can probably guess where I stand on the issue…

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More Bad News on Electronic Health Records

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By David Orentlicher

During the debate over the Affordable Care Act, the Obama administration and other proponents of electronic health records (EHRs) cited a RAND study projecting cost-savings of $80 billion a year from EHRs. More recent data have cast doubt on those estimates. In March, for example, a study in Health Affairs found that physicians with access to electronic records were more likely to order MRI scans and other diagnostic tests. Last week, the New York Times reported that EHRs apparently lead hospitals and physicians to bill more aggressively for their services, using higher billing codes than justified by the services they provide. (For an earlier post on the disappointing impact of EHR, see here.)

[Cross-posted from HealthLawProf Blog]

Will ACA Create a Doctor Shortage–And If So, What Should We Do About It?

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By Jennifer S. Bard

Being in my native land of Connecticut reminds me that Mark Twain is famously, if inaccurately, quoted as saying that everyone talks about the weather but no one ever does anything about it.  Nowhere is this concept more true today than in the handwringing over the coming shortage of physicians following the passage of Affordable Care Act.  We hear dire predictions that the patients who now have access to health care will flood the system resulting in poor care not just for them, but for those among us who were lucky enough to already have health insurance.  The American Academy of Family Physicians has recently expressed its concern that the shortage will be made up by nurse practitioners rather than physicians.

This is a situation where the shortage, if it exists, has nothing to do with fear of law suits.  Applications to U.S. medical schools have been steadily increasing.  Moreover, the shortage isn’t of doctors in general, it is of primary care physicians.  There are still a fair number of dermatologists and plastic surgeons, but not so many physicians who provide the kind of primary and preventive care that actually improve the public’s health.

Uwe Reinhardt, the Princeton health care economist, has been following this issue closely and in a series of posts for the New York Times’ Econmix Blog has been aggressively skeptical about the existence of the shortage as well as the actions taken so far by the Federal Government to address it.  He also questions the need both for the residency system as currently structured and for the benefit to the public of subsidizing it through Medicare given what a poor job it does in producing the primary care doctors the public really needs.  Last week, he undertook an extensive analysis of medical school debt which showed that by charging students intending to be high paid specialists the same as those who might go into primary care has created a loan burden that makes it difficult for any but the most dedicated to turn away from training for the most lucrative specialty for which they can qualify. Read More

What do we know about obesity and its prevention in the U.S.?

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By Rebecca Haffajee

As many are aware, the New York City Board of Health recently approved Major Michael Bloomberg’s proposed ban on sugar-sweetened beverages (SSBs) over 16 ounces in size sold at city restaurants, delis, sports venues, movie theaters, and street carts. This “soda ban” is set to go into effect on March 12, 2013. It has been justified on the grounds that it will make headway in combating obesity in NYC.  It piggybacks on a number of other anti-obesity policies enacted in the City, including a transfat ban in restaurants, a requirement that chain restaurants post calorie information, initiatives to help low income residents buy fresh produce, and nutritional standards in schools. In this Blog, Katie Booth conducted a thorough legal analysis of whether the ban could be overturned, concluding that a plaintiff’s chances of waging a successful lawsuit are slim.  Meanwhile, robust commentary in the media and health journals has debated the legitimacy of the ban and government’s role in regulating SSBs and combating obesity.

So what do we know about obesity in the U.S. as a phenomenon, its causes, and possible interventions that work to combat its spread? Although the problem is far from simple, it’s useful to briefly compile the current evidence.

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Cited by the Supreme Court: Oh, the Indignity and Humiliation of It!

Temple University Center for Public Health Law Research Leave a comment

By Scott Burris

A law professor is usually thrilled to have an article cited by the Supreme Court.  An empirical researcher will, likewise, be pleased that evidence he or she helped create shapes a decision of the highest court of the land.  But maybe not always.

Today I learned that the Supreme Court cited a study of mine in a major opinion. OK, it was the Supreme Court of Canada, but still.  The case, which deals with the criminalization of HIV, is pretty interesting and important.  The unimportant part has to do with the impact of my work on the decision:

 Some interveners challenge the use of the criminal law in the case of HIV on the ground that it may deter people from seeking treatment or disclosing their condition, thereby increasing the health risk to the carrier and those he has sex with.  On the record before us, I cannot accept this argument.  The only “evidence” was studies presented by interveners suggesting that criminalization “probably” acts as a deterrent to HIV testing: see e.g. M.A. Wainberg, “Criminalizing HIV transmission may be a mistake” (2009), 180 C.M.A.J. 688.  Other studies suggest little difference in reporting rates in states that criminalized and did not criminalize behaviour:  S. Burris, et al., “Do Criminal Laws Influence HIV Risk Behavior?  An Empirical Trial” (2007), 39 Ariz. St. L.J. 467, at p. 501.  The conclusions in these studies are tentative, and the studies were not placed in evidence and not tested by cross-examination.  They fail to provide an adequate basis to justify judicial reversal of the accepted place of the criminal law in this domain.

The Court is right, but maybe it could have gone without saying — or citing?

ACA Litigation – Oklahoma’s “Federalism Unit” Piles On

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By Nicole Huberfeld

We Who Follow ACA Litigation will continue to be in business.  [On September 19], Oklahoma’s Attorney General sought leave to amend the state’s original complaint regarding the individual mandate.  Now the state claims that the tax subsidies offered to those qualifying for financial assistance to obtain insurance through the exchanges are impermissible.  This amended complaint builds on an existing thread of new challenges that was promoted before NFIB was decided.  (The amended complaint also asks the court to consider the state’s nullification law, which should be struck down based on the Supremacy Clause.)  The ACA challengers that never advanced beyond district court have been seeking leave to amend their complaints with regularity.  Last week I posted about the Pacific Legal Foundation’s new strategy, which is rooted in the Orgination Clause.  (The case was also noted over at Balkinization.)

Oklahoma’s amended complaint is grounded in theories advanced by Jonathan Adler and the Cato Institute.  The argument is that tax credits to support the purchase of health insurance through qualified health plans in the exchanges are only available when the exchanges are created by the states, not the federal government.  They claim that section 1311 of the ACA only contemplated providing tax subsidies in state-run exchanges to incentivize states to create the exchanges and that the federally-established exchanges cannot offer the same tax benefit.  In testimony to Congress, they argued the problem is that the proposed IRS regulation implementing the subsidies for people from 100-400% of the FPL in the exchanges applies to both state and federally-run exchanges, not just state exchanges.  Thus, they claim that the IRS has exceeded its statutory authority.  As Tim Jost noted here, the ACA did intend to permit tax credits in federal exchanges.  I agree with Tim’s analysis and would add that the Anti-Injunction Act probably would apply to this provision; unlike the “penalty” of the individual mandate, this is actually described as a “tax.”  Also, the states are not the appropriate parties to raise this issue; individuals benefit from tax credits, individuals would need to pursue the alleged problem.

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The Use of Electronic Health Records Is Increasing Medicare Billing: Is It Also Increasing the Amount of Care Physicians Provide?

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 By: Katie Booth

The New York Times recently reported that the switch to Electronic Health Records (“EHRs”) may be contributing to rising Medicare costs. The Times described two hospitals where the portion of patients billed at the highest reimbursement rate rose by over 40% when the hospitals adopted EHRs. The Times also reported that in hospitals that switched to EHRs between 2006 and 2010, Medicare payments rose 47%. Medicare payments for hospitals that did not adopt EHRs rose 32%.

There are several potential explanations for this increase in billing. One is that doctors are simply doing a better job electronically recording the same care they’ve always given, leading to higher Medicare billing. Another is that some doctors are abusing the EHR system by upcoding patients or copying and pasting examination histories, fraudulently increasing Medicare billing.

A third explanation is that EHR systems actually change the way doctors practice medicine. In the process of asking doctors for particular data points, EHR systems may remind doctors to look for particular symptoms or to provide particular treatments that doctors may not have considered otherwise. It is thus possible that EHRs have led to higher Medicare bills because they have increased the amount of time doctors spend diagnosing and treating patients.

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Missouri District Court Dismisses Challenge to Contraception Mandate

Nadia Sawicki 2 Comments

By Nadia N. Sawicki

Litigation challenging the PPACA contraception mandate continues, and last week’s decision by the U.S. District Court for the Eastern District of Missouri in O’Brien v. HHS brings the total number of decisions on the merits to two (three cases – Nebraska v. Sebelius, Wheaton College v. Sebelius, and Belmont Abbey v. Sebelius – have already been dismissed for lack of standing).

Judge Carol Jackson’s opinion dismisses all the plaintiffs’ claims, but focuses primarily on the Religious Freedom and Restoration Act (RFRA) claim.   RFRA, which was passed by Congress in response to the Supreme Court’s 1990 decision in Employment Division v. Smith, applies a stricter standard of scrutiny to burdens on religious exercise than is constitutionally required under Smith.  A plaintiff who can demonstrate that his freedom of religious exercise is being substantially burdened by a law will prevail unless the government can prove that the law serves a compelling state interest using the least restrictive means possible.

With respect to O’Brien’s RFRA claim, the District Court concluded that requiring a corporate employer to cover contraception in its health insurance plan does not impose a substantial burden on the entity’s right to religious exercise.  Or rather, the entity’s hypothetical right to religious exercise – the District Court assumed for the sake of argument that a secular corporation can, in fact, “exercise” a religion.  The court concluded, however, that whatever burdens exist on the plaintiffs’ right of free exercise, those burdens are “too attenuated to state a claim for relief.”   Unlike other cases where plaintiffs have been able to demonstrate substantial burdens on religion, the PPACA contraception mandate would not prevent the plaintiffs in O’Brien from keeping the Sabbath, raising a family according to Scripture, eschewing contraception, or expressing an opinion to employees.  Rather, the mandate merely requires indirect financial support of a practice with which the plaintiffs disagree – no different, the court suggests, than paying a salary to an employee who, through her own free will, chooses to purchase an objectionable product.  While the court did not draw this connection directly, this reasoning is similar in kind to the reasoning used by courts in rejecting claims of conscientious objection by taxpayers.

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Taking Liberties (and Libertarians) Seriously

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By Abby Moncrieff

First, an uncontroversial statement: Despite academics’ resistance, libertarian arguments played a huge role in the Supreme Court’s Obamacare decision. That seems obvious. Chief Justice Roberts and the four dissenters based their Commerce Clause analyses largely on notions of individual freedom, asserting that the federal government should not be allowed to force individuals to purchase private products.

But to heath scholars, that line of analysis is incredibly irksome and even a bit dissonant. Health insurance isn’t like ordinary private products, we cry; it is intimately connected to health care regulation, and forcing people to have health insurance, unlike forcing them to buy (or even eat) broccoli, will make them healthier! Congress made this point explicitly, finding that “[t]he economy loses up to $207[ billion] a year because of the poorer health and shorter lifespan of the uninsured”! Failing to eat broccoli doesn’t make you unhealthy the same way that failing to carry insurance does, especially if you’re substituting broccoli with green beans instead of donuts. And eating broccoli doesn’t make you healthy the same way that carrying insurance does, especially if you’re also eating steaks (or eating more than 2000 calories a day of pure broccoli). So, Supreme Court, you just got it wrong. The individual mandate isn’t a crass attempt to get people to buy something. It is, like countless other uncontroversial provisions of the U.S. Code, an attempt to improve the health and longevity of the American people. If you don’t think Medicare (or a Certificate of Need law) infringes liberty, you shouldn’t think the individual mandate does.

Here’s the problem: The Solicitor General didn’t make that argument.

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NEJM: Cutting Family Planning in Texas (and more)

Holly Fernandez Lynch Leave a comment

Our friends over at the New England Journal of Medicine just alerted us to a new perspectives piece addressing the impact of cutting family planning funds in Texas (the piece was also picked up by Politico).  The authors interviewed 56 leaders of organizations throughout the state that provided reproductive health services using public funding before cuts went into effect, and what they found was disturbing:

  • Most clinics have restricted access to the most effective contraceptive methods because of their higher up-front costs (choosing pills over IUDs or subdermal implants).
  • Clinics have started to turn away those who canot pay, when previously their visits would have been covered by public funds, and women who can pay the newly instated fees are choosing less effective methods and fewer tests to save money.
  • A number of clinics have lost their exemption from Texas’ law requiring parental consent for teens under 18 who seek contraceptives.

Overall, the authors conclude that laws intended to defund Planned Parenthood in an attempt to limit access to abortion (even though federal and state funding cannot be used for abortion anyway) have resulted in policies limiting women’s access to range of preventative reproductive health services and screenings.

Alta Charo weighs in via a NEJM podcast, discussing the future of reproductive health care for women in the US, particularly in light of upcoming elections (as well as the article we discussed last week on conscientious action, and other general issues in reproductive health policy).  Take a listen!

And one more NEJM plug for now: our Bill of Health blogger Kevin Outterson also has a podcast online discussing the record-breaking settlements of pharmaceutical fraud cases and the need for further regulation.