Category: Health Law

University of Utah Conference on Precision Medicine

Via Leslie Francis, news of a great conference at the University of Utah on precision medicine on Dec. 1 and 2. It will be livestreamed:

The federal Precision Medicine Initiative (PMI) announced in 2015 will be the largest study of human genetics and health in history. With a planned cohort of one million Americans, the PMI promises to increase our understanding of the genetic basis of disease and forge the way for new diagnostic and therapeutic innovations. The PMI is linked to another ambitious national initiative, Vice President Joe Biden’s “Cancer Moonshot,” which hopes to accelerate the cure for cancer using big data and precision oncology techniques. Though the technology to undertake these monumental projects exists today, many scientific, legal, economic, and ethical questions remain. This one and a half day symposium at the University of Utah will host leading national experts in medicine, bioinformatics, law, policy and ethics who are tackling the major questions raised by precision medicine, the PMI, and the Cancer Moonshot.

I wish I could watch, but I will be speaking at another conference. Best wishes to the Utah group!

Rebuilding Health Care Policy from the Ground Up

whatourdemocraticparty

Campaign Flier from the Wright Patman Archives (via Matthew Stoller)

The signature progressive initiative of early 21st century America–the Affordable Care Act–is about to be gutted.  In 2009, I agonized about whether to support it. In the last paragraph of a bloated blog post, I concluded:

By passing this reform bill, Democrats will jettison whatever “populist” credentials they once had, opting instead for an early-twentieth-century “progressive” vision of technocratic alliance between corporate and government experts. . . . We’ll commence an endless argument (read: notice and comment rulemaking and subsequent administrative adjudications) over what constitutes an adequate baseline of coverage. . . . But the fundamental victory of reform–the national commitment that no one should have to choose between death or bankruptcy when confronted with a serious illness–will also endure. The tragic paradox is that the Democrats can only achieve this great cultural and ideological victory by becoming identified with the very interests that only they are willing to confront.

I was right about a few things: it was a Pyrrhic victory, the backlash was brutal, and virtually every indignity or imposition concocted by private insurers in the past seven years has been blamed on “Obamacare.” But I was wrong about the most important points. The rulemaking and adjudications will end. The Trump/Ryan/McConnell approach to health care will leave Obamacare in the dustbin of history. And when it does, it will impose on millions of Americans exactly the situation they faced pre-ACA: choose between death or bankruptcy when confronted with a serious illness.

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In October, Larissa MacFarquhar published a thoughtful essay on “The Heart of Trump Country.” One supporter of the President-elect said:  “When you hear about illegal aliens getting benefits and you have people here starving to death and can’t get nothing, it’s just a slap in the face. When you start talking about bringing in refugees and when they get here they get medical and dental and they get set up with some funds—what do we get?” Here’s Obamacare’s answer:

Under the terms of the ACA, if you are unemployed, or if your employer’s insurance is unaffordable (defined as an individual plan (not a family plan) costing you over 9.5% of income), you can buy insurance on the exchange. You can choose plans from one of four precious metal tiers (bronze, silver, gold, and platinum), with varying actuarial values (60 to 90%). You’ll pay premiums, but you’ll also get sliding scale subsidies based on how high your income is above the poverty level. You will probably also need to pay co-pays, coinsurance (a percentage of each bill), and deductibles, up to some percentage of your income specified by statutory out-of-pocket maximums. (Just be sure not to incur out-out-network costs that don’t count toward out-of-pocket maximums.)

But you can get cost-sharing subsidies to cover some of that expense, based on a sliding scale slightly different than the premium assistance tax credit scale. Just be sure to shop carefully on the exchange, because some plans have narrow networks–that is, they may not cover the physicians or hospitals you normally use. In fact, you may have to drive 20 or 50 miles to find a physician in the network–the rules on network adequacy can be hazy. Note also that, in a narrow network, if you have a surgery, it’s possible out-of-network physicians or other personnel may attend, and you could be on the hook for the whole amount they charge–unless your state has a “no surprise billing” law.

Read More

The Phantom Industrial Policy of the Beltway’s Favorite Health Cost Cutters

A few weeks ago, I spoke on artificial intelligence in health care at the AI Now Conference. I focused on the distinction between substitutive automation (which replaces human labor with software or robots) and complementary automation (which deploys technology to assist, accelerate, or improve humans’ work). I developed three cases where complementary automation ought to be preferred: where it produces better outcomes; in sensitive areas like targeting persons for mental health interventions; and to improve data gathering. Law and policy (ranging from licensure rules to reimbursement regs) could help assure that the health care sector pursued complementary automation where appropriate, rather than chasing the well-hyped narrative of robot doctors and nurses.

The pushback was predictable. Even if complementary automation is better now, shouldn’t our policy reward firms that try to eliminate ever more labor costs? Doesn’t *everyone* agree that the US spends too much on health care–and isn’t technology the best way of reducing that spending? Let me try to address each of these views, boiling down some perspectives from a longer, academic article.

A Policy at War with Itself

There is a troubling tension at the heart of US labor policy on health care and automation. Numerous high-level officials express grave concerns about the “rise of the robots,” since software is taking over more jobs once done by humans. They also tend to lament growth in health care jobs as a problem. In an economy where automation is pervasive, one would think they would be thankful for new positions at hospitals, nursing homes, and EHR vendors. But they remain conflicted, anxious about maintaining some arbitrary cap on health spending.

Politico reporter Dan Diamond encapsulated this conflict in his recent article, “Obamacare: The Secret Jobs Program”–and he leaves no uncertainty about which side he thinks is right:
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Platform Responsibility

Internet platforms are starting to recognize the moral duties they owe their users. Consider, for example, this story about Baidu, China’s leading search engine:

Wei Zexi’s parents borrowed money and sought an experimental treatment at a military hospital in Beijing they found using Baidu search. The treatment failed, and Wei died less than two months later. As the story spread, scathing attacks on the company multiplied, first across Chinese social networks and then in traditional media.

After an investigation, Chinese officials told Baidu to change the way it displays search results, saying they are not clearly labeled, lack objectivity and heavily favor advertisers. Baidu said it would implement the changes recommended by regulators, and change its algorithm to rank results based on credibility. In addition, the company has set aside 1 billion yuan ($153 million) to compensate victims of fraudulent marketing information.

I wish I could include this story in the Chinese translation of The Black Box Society. On a similar note, Google this week announced it would no longer run ads from payday lenders. Now it’s time for Facebook to step up to the plate, and institute new procedures to ensure more transparency and accountability.

The State of Legal Scholarship: A View from Health Law

Based on Ron Collins’ post below, I read the interview with Judge Edwards. The judge states:

In order for legal scholarship to be relevant outside the legal academy, law professors should balance abstract scholarship with scholarly works that are of interest and use to lawyers, legislators, judges, and regulators who serve society through legal arguments, decision-making, regulatory initiatives, and enforcement actions.

Fortunately, every legal academic that Nicolas Terry and I have hosted in our 41 episodes of The Week in Health Law has done so. Perhaps that’s a biased sample. But it’s undoubtedly better than the sampling practiced by Justice Breyer, another critic of legal scholarship.

For now, I will take some comfort that, about a year into our podcasting, we have heard from general counsels, attorneys, regulators, and journalists who are big fans of the show–which primarily focuses on the work of legal academics. And I will remain dubious of generalized critiques of legal scholarship, which fail to analyze the merits of particular fields.

Greene & Kesselheim vs. Kardashian

Jeremy Greene and Aaron Kesselheim have a fascinating piece on the new challenges facing the FDA as selfie-driven marketing reaches Instagram. After promoting an anti-nausea drug (for morning sickness, not in anticipation of celebrity-phobic viewers), Kardashian had to follow up with the following “corrective advertisement:”

#CorrectiveAd I guess you saw the attention my last #morningsickness post received. The FDA has told Duchesnay, Inc., that my last post about Diclegis (doxylamine succinate and pyridoxine HCl) was incomplete because it did not include any risk information or important limitations of use for Diclegis.

As Greene and Kesselheim observe:

The rise of social media has raised a parade of new questions for the agency: How is it supposed to monitor person-to-person pharmaceutical recommendations? Can something be considered an advertisement if it’s only 140 characters long? Who is responsible for the accuracy of tweets about a drug? But this isn’t the first time evolving technology has forced the FDA to rethink its role. Before Instagram, television advertising was once new; before television, radio. Since the agency’s founding, its ability to regulate drugs has been consistently challenged by new forms of communication.

For more on the controversy, check out The Week in Health Law, where Nicolas Terry and I discuss the case with Kesselheim. And don’t worry, it’s not all about Kardashians–we also cover a new study of ACOs, proposed budget cuts for AHRQ, worry over unintended consequences of readmission penalties, and EHR gag clauses (and developer codes of conduct).

The Week in Health Law, Back to School Edition

If you want to learn about a fast-changing field, check out health law. It’s hard to keep track of all the recent developments in subfields of it (bioethics, insurance regulation, malpractice, EHRs and privacy, among others), let alone the field as a whole. Fortunately, there are many scholars and practitioners who are diligently working on all these issues. Nic Terry interviewed many of them for our “Back to School” podcast on health law.

Here are the contributors, with links to articles on the issues they discussed:
Micah Berman – PBS Unnatural Causes
Erin Fuse Brown – Physician Self-Referral Updates (STARK)
Glenn Cohen – Egg freezing and egg banking: empowerment and alienation in assisted reproduction
Brietta Clark – Pickup v. Brown
Nicole Huberfeld – Armstrong v Exceptional Child Center Inc. 
Elizabeth Weeks Leonard – King v. Burwell
Frank Pasquale – Narrow Networks
Ross Silverman – Should childhood vaccination against measles be a mandatory requirement for attending school? Yes
Norman G. Tabler, Jr.–  Can an Arbitrator Rule Against a Hospital for Not Violating the Anti-Kickback Statute?
Nicolas Terry – North Carolina State Board of Dental Examiners v. Federal Trade Commission

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter: @nicolasterry and @HealthPI (for my health tweets) or @FrankPasquale (for law & tech, surveillance, algorithms & political economy). @WeekInHealthLaw is the show feed.

 

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FAN 70.1 (First Amendment News) Amarin v. FDA –Important Commercial Speech Case May be Decided Soon

The FDA has long sought to ban manufacturers from promoting off-label uses of approved drugs and medical devices.  In taking the position that manufacturers and their agents cannot promote off-label uses, the FDA suggests they are safeguarding the public from misbranded medical products and ensuring that manufacturers do not circumvent the drug and device approval processes. Critics, however, have long contended that the FDA’s position violates the First Amendment to the extent it prohibits truthful speech. — Evelien Verpeet, ReedSmith, June 18, 2015

Should pharmaceutical companies be able to advertise drugs for uses not  approved by the FDA? It seems like a no brainer — of course not! But as with so many other things in life and law, the answer (especially the First Amendment answer) is not so obvious.

→ The caseAmarin Pharma, Inc. v. United States Food & Drug Administration (Dist. Ct., S. Dist. NY).

→ Judge: The matter was argued before U.S. District Judge Paul A. Engelmayer on July 7, 2015. A ruling is expected soon.

Unknown5→ Plaintiff’s Claim: “Amarin Pharma wants to provide healthcare professionals with truthful, non-misleading information about its prescription drug Vascepa®, and four doctors who want to receive that information, as they determine when and whether to prescribe that drug. If Amarin provides that information, however, it is at high risk of criminal and civil sanctions being sought against it by the United States.”

U.S. Atty. Preet Bharara

U.S. Atty. Preet Bharara

→ Government’s Claim: “Plaintiffs seek a court order that would allow Amarin to distribute its drug Vascepa under circumstances which could establish that Amarin intends an unapproved new use for Vascepa, i.e., a use for which FDA has not determined that the drug is safe and effective. But Plaintiffs’ legal arguments strike at the very heart of the new drug approval process, and a court decision in Plaintiffs’ favor has the potential to establish precedent that would return the country to the pre-1962 era when companies were not required to prove that their drugs were safe and effective for each of their intended uses.”

The FDA has long banned promotion of drugs for uses other than those it has approved. Yet so-called off-label uses are legal and account for about 20% of all prescriptions. Some off-label uses of drugs have even become the standard of care for particular conditions. But the drug’s manufacturer and its agents—and only them—cannot legally talk about this. Patients can—and do—discuss off-label uses of drugs endlessly in online forums. Doctors certainly exchange information about these uses. — David B. Rivkin Jr. &  Andrew Grossman, WSJ, May 21, 2015

 P’s Counsel: Floyd Abrams is the lead counsel for the Plaintiff with Joel Kurtzberg and Michael B. Weiss (see here re P’s complaint)

→ Gov.’s CounselPreet Bharara is the attorney for the Defendant along with Ellen London and Benjamin Mizer

→ Amicus Briefs: Pharmaceutical Research and Manufacturers of America and Washington Legal Foundation — both in support of the Plaintiff / Public Citizen in support of the United States

→ FDA Letter to Judge Engelmayer, June 8, 2015 (see here for a discussion of the mootness issue raised by this letter)

Excerpts from United States v. Caronia (2nd Cir. 2012) re off-label promotions 

The government’s construction of the FDCA asprohibiting off-label promotion does not, by itself, withstand scrutiny under Central Hudson’s third prong [that the regulation directly advance the government’s interests] . . . . The last prong of Central Hudson requires thegovernment’s regulation to be narrowly drawn to further the interests served. . . Here, the government’s construction of the FDCA to impose a complete and criminal ban on off-label promotion by pharmaceutical manufacturers is more extensive than necessary to achieve the government’s substantial interests. . . . We conclude simply that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug. Judge Denny Chin for the majority.

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[T]he majority calls into question the very foundations of our century-old system of drug regulation. I do not believe that the Supreme Court’s precedents compel such a result. . . . If drug manufacturers were allowed to promote FDA-approved drugs for non-approved uses, they would have little incentive to seek FDA approval for those uses. — Judge Debra Ann Livingston dissenting

Summary of Amarin’s First Amendment Arguments Read More

Corporate Experimentation

Those interested in the Facebook emotional manipulation study should take a look at Michelle N. Meyer’s op-ed (with Christopher Chabris) today:

We aren’t saying that every innovation requires A/B testing. Nor are we advocating nonconsensual experiments involving significant risk. But as long as we permit those in power to make unilateral choices that affect us, we shouldn’t thwart low-risk efforts, like those of Facebook and OkCupid, to rigorously determine the effects of those choices. Instead, we should…applaud them.

Meyer offers more perspectives on the issue in her interview with Nicolas Terry and me on The Week in Health Law podcast.

For an alternative view, check out my take on “Facebook’s Model Users:”

[T]he corporate “science” of manipulation is a far cry from academic science’s ethics of openness and reproducibility. That’s already led to some embarrassments in the crossover from corporate to academic modeling (such as Google’s flu trends failures). Researchers within Facebook worried about multiple experiments being performed at once on individual users, which might compromise the results of any one study. Standardized review could have prevented that. But, true to the Silicon Valley ethic of “move fast and break things,” speed was paramount: “There’s no review process. Anyone…could run a test…trying to alter peoples’ behavior,” said one former Facebook data scientist.

I just hope that, as A/B testing becomes more ubiquitous, we are well aware of the power imbalances it both reflects and reinforces. Given already well-documented resistance to an “experiment” on Montana politics, it’s clear that the power of big data firms to manipulate even the very political order that ostensibly regulates them, may well be on the horizon.

“They Cannot Breathe:” Poisoned Workers in Nail Salons

The grim story of deregulation in the US economy has another victim: nail salon workers. A New York Times expose has won tremendous attention to their plight in an industry that has long resisted regulation:

Some states and municipalities recommend workers wear gloves and other protection, but salon owners usually discourage them from donning such unsightly gear. And even though officials overseeing workplace safety concede that federal standards on levels of chemicals that these workers can be exposed to need revision, nothing has been done. So manicurists continue to paint fingertips, swipe off polish and file down false nails, while absorbing chemicals that are potentially hazardous to their health. . . .

In interviews with over 125 nail salon workers, airway ailments . . . were ubiquitous. Many have learned to simply laugh them off — the nose that constantly bleeds, the throat that has ached every day since the manicurist started working.

For those interested in the legal background, I highly recommend a piece by my former student, Kelsey-Anne Fung. In 2014, she concluded:

Southeast and East Asian immigrant nail salon workers face disproportionate exposure levels to dangerous and carcinogenic nail products, and as a result, suffer severe health outcomes at unusually high rates. Without FDA authority of pre-market approval, testing, or recall, the cosmetic industry is wholly self–regulated, resulting in scarce protections to consumers and professions who use nail products on a daily basis. Salon owners often pay below minimum wage, do not provide health insurance or any benefits, and fail to supply adequate safety equipment. Consequently, workers must rely on community safety net clinics and public hospitals for medical care to treat ailments from working in the nail salon, paying steep out–of–pocket rates. On its own, the Patient Protection and Affordable Care Act does not remedy any of the health policy issues facing immigrant nail salon workers. Thus, [state-level interventions] may be the only viable solution to securing preventative and affordable health care services for this overburdened and vulnerable labor force.

Both Fung’s article, and the NYT piece, are must-reads for anyone concerned about the fate of workers in an increasingly deregulated environment.