Authors

David Orentlicher, MD, JD, is the Judge Jack and Lulu Lehman Professor at UNLV William S. Boyd School of Law, Director of the UNLV Health Law Program, and a Member of the Nevada Assembly.
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Appeals Court Overturns FDA’s Partial Ban on Shock Devices: Analysis of Ruling

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By David Orentlicher

In its regulation of medical devices, the U.S. Food and Drug Administration (FDA) may ban devices that pose “an unreasonable and substantial risk of illness or injury.” But earlier this month, the U.S. Court of Appeals for the D.C. Circuit decided that the FDA may not issue a partial ban of a medical device.

The case, Judge Rotenberg Educational Center v. FDA, addressed the use of electrical stimulation devices to treat self-injurious or aggressive behavior, as in patients with serious intellectual or developmental disabilities.

In March 2020, the FDA attempted to prohibit this use of electrical stimulation (or electrical shock) because of the risks it poses to patients. As the FDA observed, persons with self-injurious or aggressive behavior may have “difficulty communicating pain and other harms caused by” electrical stimulation, and consent to the use of electrical stimulation is typically made by a third party, limiting the patient’s control over use of the device.

In other settings, including smoking cessation treatment, or treatment of substance use disorder, the FDA permits the practice. Hence the partial, rather than total, ban of electrical stimulation devices.

But by a 2-1 vote, the Judge Rotenberg Educational Center court held that prohibiting electrical stimulation in some settings, but not others, runs afoul of a “practice of medicine” statutory provision. This provision precludes the FDA from limiting or interfering with a health care practitioner’s authority “to prescribe or administer any legally marketed device to a patient for any condition or disease.” In the majority’s view, once the FDA permits use of a medical device, it must defer to the states for regulation of decisions regarding which patients are appropriate candidates for the device.

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CHICAGO, ILLINOIS, USA - JUNE 8, 2019: First ever Medicare for All rally led by Bernie Sanders held in The Loop of Chicago. Crowd holds up a sign that says "Medicare for All Saves Lives".

Medicare for the Poor

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By David Orentlicher

While Medicare-for-All has proved controversial, every Democratic presidential candidate should embrace one of its key elements—folding the Medicaid program into the Medicare program. That would be much better for patients, doctors, and hospitals. It also would be much better for public school children.

Medicare would be a much better program for patients, doctors, and hospitals in several ways. Lower-income families suffer because Medicaid is a federal-state partnership, and some states have stingier Medicaid programs than do other states. In particular, Florida, Texas, and twelve other states have not signed up for the Affordable Care Act’s Medicaid expansion, leaving more than two million lower-income Americans uninsured. Under our current Medicaid system, access to health care for the indigent depends where they live. Folding Medicaid into Medicare would give the poor access to health care in every state.

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CHICAGO, ILLINOIS, USA - JUNE 8, 2019: First ever Medicare for All rally led by Bernie Sanders held in The Loop of Chicago. Crowd holds up a sign that says "Medicare for All Saves Lives".

Sustaining the Promise of Universal Access

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By David Orentlicher

Should the United States achieve universal access to health care by adopting a single-payer, Medicare-for-All kind of system? Or should we build on the Affordable Care Act (ACA) and not disrupt the health care coverage of the 160 million Americans who have private health insurance?

Both reforms rely on important arguments about affordability, feasibility, and consumer choice. But there is one key reason to favor a single-payer system over an expansion of our current system. Experience with public benefit programs in the United States tells us that such programs thrive only when they serve all Americans.

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A photograph of miniature figures of people standing on top of piles of coins at different heights

Promoting Health, Not Just Health Care

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By David Orentlicher

Once again this past Thursday, the Democratic presidential candidate debate began on the topic of health care reform, and moderator George Stephanopoulos quickly steered the discussion to what he termed “the heart” of the debate. Should the United States increase access to care by building on the Affordable Care Act (ACA) or by replacing ACA with a single-payer, Medicare-for-All system?

While this is an important question, there is an even more important question for the candidates to discuss. We need to hear them talk more about health than about health care.

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How the GOP Misread Public Anger over Obamacare

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By David Orentlicher

In today’s New York Times, Kate Zernike reports on the lack of excitement among conservative activists for the Republican health care legislation. As Zernike observes, “President Trump and congressional leaders are getting little support from what were once the loudest anti-Obamacare voices.”

Some observers think that activists are disappointed in the failure of the GOP proposals to go far enough in repealing the Affordable Care Act. But that’s not the real story. In general, the public likes many of Obamacare’s key provisions, such as the protections for people with preexisting medical conditions or the ability of parents to insure their children up to age 26. Even among Republicans, there is majority support for the ban on higher premiums because of preexisting conditions and also for the mandate that insurers cover “essential health benefits.” And by 2014, Obamacare had faded as a campaign issue for Republican candidates for Congress.

So why don’t grassroots Republicans care so much about repealing the Affordable Care Act? Tea Party activists and other voters were genuinely mad about Obamacare, and they fueled the Republican wave in the 2010 House elections that saw Republicans gain 63 seats. But what made them angry was the feeling that President Obama cared more about health care than he did about the economy. In March 2010, when Obama signed the Affordable Care Act into law, the unemployment rate was 9.7 percent. The public cared much more about jobs than about health care insurance, and they saw their President focusing on health care. Remember how many times Obama promised to “pivot” back to the economy?

Voters elected President Trump and gave Republicans majorities in the House and Senate because they wanted more jobs at better pay. If the GOP lets health care distract it from economic stimulus, we may see another wave election in 2018.

Is Mike Pence’s Medicaid Expansion a Blueprint for Donald Trump’s Health Care Reform?

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By David Orentlicher

[cross-posted at orentlicher.tumblr.com]

Donald Trump’s pledge to repeal and replace the Affordable Care Act has looked much more like a plan for repeal than a plan to replace, especially in light of the kinds of reform proposals advanced by leading Republicans in Congress, including Trump’s designee for Secretary of HHS, U.S. Rep. Tom Price.

But Trump’s recent promise of “insurance for everybody,” suggests that he might actually have a serious replacement in mind. While we cannot automatically take Trump at his word, it may be the case that he is following the example of his Vice President-elect Mike Pence, who as Governor of Indiana defied Republican positioning in signing on to the Affordable Care Act’s Medicaid expansion. Read More

Abortion and the Fetal Personhood Fallacy

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By David Orentlicher

[cross-posted at HealthLawProfs blog and orentlicher.tumblr.com]

Marco Rubio, Mike Huckabee, and other politicians continue to assert a common fallacy about abortion—because human life begins at conception, fetuses are persons, and abortion must be prohibited. Indeed, Huckabee and Rubio claim that the U.S. Constitution requires such a result.

But they are wrong. And not just because people disagree about the beginning of personhood. The flaw in the Rubio/Huckabee logic was pointed out more than 40 years ago, even before the U.S. Supreme Court recognized a constitutional right to abortion in Roe v. Wade. In “A Defense of Abortion,” Professor Judith Jarvis Thomson correctly observed that even if we assume that personhood begins at conception, it does not follow that abortion must be banned before the fetus is viable. Indeed, as she wrote, a ban on abortion before fetal viability would be inconsistent with basic principles of law. Read More

Payments to Egg “Donors”

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By David Orentlicher

[cross-posted at HealthLawProfs blog and orentlicher.tumblr.com]

Interesting article in today’s Wall Street Journal about a lawsuit over limits on payments by fertility clinics to women who supply eggs for infertile couples. Under influential, though not mandatory, guidelines issued by the American Society for Reproductive Medicine, payments to egg “donors” above $5,000 “require justification,” and payments greater than $10,000 “are not appropriate.” (When I was in the Indiana legislature, a statute was passed limiting payments to $4,000, plus out-of-pocket expenses.)

In one view, payment caps are needed to “prevent coercion and exploitation in the egg-donation process.” But one also can view the guidelines as an “illegal conspiracy to set prices in violation of antitrust laws.” More to come in a case that could go to trial next year.

In the meantime, there are other important concerns about payments for eggs and the costs to infertile persons. As with other assisted reproductive treatments, insurers generally do not cover those costs. This encourages the infertile to seek multiple births in one treatment cycle rather than single births over multiple treatment cycles, which puts mothers and their infants at greater risks to health. In addition, lack of coverage leaves treatment unaffordable for many of the infertile. As I have argued elsewhere (here and here), social policy treats infertile persons unfairly when coverage is denied for assisted reproductive services,

Hobby Lobby Fall Out

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By David Orentlicher

[cross-posted at HealthLawProfs blog and orentlicher.tumblr.com]

For those who feared that the Supreme Court’s Hobby Lobby decision would open the door for employers to block contraceptive access for women in the workplace, welcome reassurance has come this week from the U.S. Court of Appeals for the Fifth Circuit. According to the Fifth Circuit, when the Affordable Care Act requires that contraception coverage be available for workers at religiously-affiliated institutions, the Act also accommodates the scruples of employers who have religiously-based objections to contraceptive use.

As the Fifth Circuit observed, employers with religious objections to contraception can shift the responsibility for coverage to their insurers or the federal government. Hence, there is no unlawful burden on those employers from the mandate that health care plans cover the costs of contraception. Read More

Affordable Care, the Supreme Court, and the Wisdom of Crowds

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By David Orentlicher

[cross-posted at HealthLawProfs blog and orentlicher.tumblr.com]

How will the Supreme Court rule on the challenge to the Affordable Care Act’s subsidies that help millions of lower- and middle-income Americans afford their health care coverage? According to FantasySCOTUS’s court watchers, who have correctly predicted more than 70 percent of Supreme Court decisions so far this year, Obamacare should remain intact.

This result is not surprising. The arguments in favor of the government are much stronger than are those for the challenger. To be sure, the challengers cite to two lines in the Affordable Care Act (ACA) that authorize subsidies for insurance bought on state-operated health insurance exchanges, without mentioning federally-operated state exchanges. Hence, argue the challengers, subsidies should be provided only for insurance purchased on state-operated exchanges, which means in only about 1/3 of states. But other language in ACA indicates that the subsidies are available for insurance purchased on all exchanges. When a statute’s language is ambiguous and there are reasonable alternative interpretations, courts are supposed to defer to the executive branch’s interpretation, not substitute their own interpretation. Read More