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TWIHL: Innovation and Protection: The Future of Medical Device Regulation, Episode 3

This is the last of three episodes of “Innovation and Protection: The Future of Medical Device Regulation,” a podcast miniseries created to replace the 2020 Petrie-Flom Center Annual Conference in light of the COVID-19 pandemic.

These episodes highlight a selection of papers that were written for the conference, which was organized in collaboration with the University of Copenhagen’s Center for Advanced Studies in Biomedical Innovation Law (CeBIL) and the University of Arizona Health Law Program. All of the papers will be published in an edited volume.

This third episode looks at recent advances in medical device regulation in the U.S. and abroad, and the effects of the COVID-19 pandemic on national and international medical device regulation.

First, Timo Minssen, Professor of Law and Director, Center for Advanced Studies in Biomedical Innovation Law (CeBIL), University of Copenhagen and Researcher in Quantum Law, Lund University, interviews Helen Yu, Associate Professor at the University of Copenhagen, Faculty of Law and Associate Director of CeBIL about her paper “Regulation of Digital Health Technologies in the EU: Intended vs. Actual Use.”

Minssen returns to talk with Janos Meszaros, Postdoctoral Research Fellow at Taiwan’s National Academy of Science about “Challenges at the Interface of EU Medical Device Regulation and the GDPR: Do the Rules on Privacy and Scientific Research Impair the Safety of AI Medical Devices?”

Finally, Christopher Robertson discusses “Preventing Medical Device-Borne Disease Outbreaks: Improving High-Level Disinfection Policies for Scopes and Probes,” with author Preeti Mehrotra, Attending Physician, Beth Israel Deaconess Medical Center and Instructor of Medicine, Harvard Medical School.

The Week in Health Law Podcast from Nicolas Terry is a commuting-length discussion about some of the more thorny issues in health law and policy. Subscribe at Apple Podcasts or Google Play, listen at Stitcher Radio, SpotifyTunein or Podbean.

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 me on Twitter @nicolasterry or @WeekInHealthLaw.

Access to Drugs Before FDA Approval: Video Explainer with Christopher Robertson.

Access to Drugs Before FDA Approval: Video Explainer with Christopher Robertson

The COVID-19 pandemic has raised many questions about the regulation of drugs in the United States.

One such concern relates to the use of drugs for treatment of COVID-19 that have not yet been FDA approved.

In this video explainer produced by the James E. Rogers College of Law of The University of Arizona, Christopher Robertson, Professor of Law and Associate Dean for Research & Innovation, discusses these issues, including the Right to Try Act and off-label use of pharmaceuticals, with NYU Grossman School of Medicine’s Alison Bateman-House, MPH, PhD.

FDA Commissioner Rolls Back 40 Years of Orthodoxy on Cost-Exposure

FDA Commissioner Scott Gottlieb

Speaking yesterday at America’s Health Insurance Plans’ (AHIP) National Health Policy Conference, FDA Commissioner Scott Gottlieb railed against patient cost-exposure (e.g., copays).   His prepared speech said:

Patients shouldn’t be penalized by their biology if they need a drug that isn’t on formulary. Patients shouldn’t face exorbitant out of pocket costs, and pay money where the primary purpose is to help subsidize rebates paid to a long list of supply chain intermediaries, or is used to buy down the premium costs for everyone else. After all, what’s the point of a big co-pay on a costly cancer drug? Is a patient really in a position to make an economically-based decision? Is the co-pay going to discourage overutilization? Is someone in this situation voluntary seeking chemo?  Of course not.  Yet the big co-pay or rebate on the costly drug can help offset insurers’ payments to the pharmacy, and reduce average insurance premiums. But sick people aren’t supposed to be subsidizing the healthy.

Wow.  This may seem like common sense to some readers, but it is revolutionary to hear from a senior American government official, and indeed a Republican one no less.

In a new paper, Victor Laurion and I have chronicled the ways in which American politicians at the highest levels have blindly embraced the opposite point of view for half-a-century.  This sort of ideological adherence to simplistic economic reasoning (which James Kwak calls ‘economism‘) is  why U.S. health insurance exposes patients to all sorts of deductibles, copays, and coinsurance.  As a result, even insured Americans find themselves “underinsured” — denied access to care or falling into bankruptcy if they stretch to pay nonetheless. Read More

“Right to Try” Does Not Help Patients

Co-Blogged by Christopher Robertson and Kelly McBride Folkers (research associate at the Division of Medical Ethics of the NYU School of Medicine)

In 2014, Arizonans overwhelmingly voted in favor of a ballot referendum that claimed to allow terminally ill patients the “right to try” experimental drugs that have not yet been approved by the Food and Drug Administration (FDA). Despite the policy’s broad support, it has yet to help a single patient in Arizona obtain an experimental drug that they couldn’t have gotten before. Thirty-seven other states have also passed right to try bills, but likewise have seen little real impact for patients.

“Right to try” has moved to the federal stage, as the U.S. Senate unanimously passed such a bill last August without even holding a hearing. The House Energy & Commerce Subcommittee on Health considered the bill in an October hearing, but it failed to garner much enthusiasm among committee members. Vice President Mike Pence has advocated for a federal right to try law, and he recently met with FDA Commissioner Scott Gottlieb and House leadership to encourage pass of the bill this year. Read More

Medical Bills are Open-Price Contracts: A Victory for the Little Guy

This blog has often covered the problem of outrageous medical bills, and explored whether patients have a responsibility to pay the balance on charges that are not covered by insurance.  One common pattern is that the patient agrees to pay “all reasonable charges” when they arrive at the emergency room or other provider, and then months later receives an incomprehensible bill for seemingly outrageous amounts.  The costs of the same healthcare can vary wildly from provider to provider, even in the same locale, and there seems to be little rhyme or reason.  (This is a common refrain of Elizabeth Rosenthal’s 2017 book.)

According to very basic contract law, when the agreement between a buyer and seller does not specify the prices to be charged (aka an “open price contract”), the seller may not demand more than a “reasonable” amount.   Years ago, I was involved in nationwide litigation against non-profit hospitals, raising this theory and alleging that their billing practices contradicted their state and federal “charitable” tax exemptions, since they were driving poor people into bankruptcy and foreclosure.  That litigation had a few notable wins, when several hospital systems agreed to adopt explicit charity care policies and stop some of the more egregious practices, such as putting liens on their patients’ houses.  Some of these reforms became an industry standard and then part of the Affordable Care Act.

Overall, however, this litigation was challenging, because courts tended to hold that the reasonableness of each patient’s medical bills had to be litigated individually – often with expert witnesses and comparable data from the healthcare provider and other competitors.  With only a few thousand dollars at stake for each patient, the courts’ refusal to aggregate the litigation left many consumers without an effective recourse to challenge their unreasonable bills. Contingent-fee attorneys tend to look for larger stakes to make their investment of time and expenses worthwhile. Read More

Special Deals for States?

By Christopher R. Robertson

Over at HuffPo, Craig Konnoth has a short-but-smart piece exploring the Constitutionality of the logrolling deals now underway to persuade Alaska Senator Lisa Murkoswki to support the latest effort to repeal Obamacare.  Would other states have a right to object to a deal that showered special benefits on Alaska?  Konnoth explains how an “equal sovereignty” principle has emerged in recent Supreme Court decisions, and suggests that it may provide some grounds for challenging this sort of special treatment.

I am left wondering about the longstanding practices of states requesting and receiving waivers from the Federal government.  For example, Maryland has for decades enjoyed a Medicare waiver, which allows it to regulate prices.  Massachusetts has a $52B waiver to put its Medicaid members in accountable care organizations.   Do these violate equal sovereignty too?

Maybe the answer is that all states are treated equally in their right to apply for such waivers, under several explicit statutory vehicles, which have yielded several hundred such applications.  These are not simply bribes to secure votes in Congress.  On the other hand, some of these waivers were very much the result of politically-charged negotiations between conservative governors (such as Indiana’s Mike Pence) and the Obama administration, who granted these waivers as a way to expand insurance coverage.  Maybe that’s not so different than what Murkowski is demanding?

On related questions, also check out Brian Galle’s piece over at Medium.com.

How the FDA Produces Knowledge (and Is Not So Weird)

Credit: SalFalko

The Federal government has wrested billions of dollars from the drug and device industry in settlements of claims that the companies broke the law by promoting their products “off-label” for uses not approved by the FDA.  In response, companies have asserted that promotions are a form of speech, protected by the First Amendment. Speech regulations are especially worrisome when motivated by paternalism.  This argument has received some traction in the courts, and is now getting a favorable look by the Trump administration.

I have argued (here, here, and here) that this law is not actually a speech regulation.  Nor is it paternalistic.  Instead, it is simply a vanilla regulation of a behavior (shipment of product in interstate commerce), which depends on various sources of evidence (including speech) as revealing whether the actor has an illicit intent (an unapproved use of the product).  The pre-market approval system, which requires that companies prove safety and efficacy for all intended uses, solves a collective action problem to produce information as a public good.  This is our key social mechanism for producing knowledge about safety and efficacy.  If this law is unconstitutional in the off-label context, the entire pre-market approval system would seem to be as well.

In a new piece out on SSRN, my physician co-author Victor Laurion develops the example of the drug Seroquel XR, to show how a federal prosecution for off-label promotion caused the company to perform scientific research on two new indications (general anxiety disorder and major depression).  A detailed discussion of the regulatory record shows how physician prescribing was improved by this public information, regardless of whether the FDA approved the new indication.  In this way, the FDA protects the liberty of physicians and patients to try drugs for new uses, even while holding companies to the proof of any uses that they actually intend.  The fact that the company’s intention is shown by speech evidence is immaterial. Read More

Is it legal for Trump to punish health insurers that do not support repeal of Obamacare?

By Christopher Robertson

In a recent story about how the health insurance marketplaces are being destabilized by the Trump administration’s vacillation, the LA Times reports:

At one recent meeting, Seema Verma, whom Trump picked to oversee the federal Medicare and Medicaid programs, stunned insurance industry officials by suggesting a bargain: The administration would fund the CSRs if insurers supported the House Republican bill to repeal the Affordable Care Act.

For what its worth, the Trump administration denied that she had done so.  But if she did, is that legal?  Can politicians actually offer to give money from the Federal Treasury to companies in exchange for their political support (or withhold it for lack of that support)?  If Ms. Verma was corruptly offering a “quid pro quo” exchange (as TalkingPointsMemo says), that would fit the statutory definition of the crime of bribery, as I discuss in a 2016 paper, The Appearance and Reality of Quid Pro Quo Corruption. However, this case also implicates the First Amendment rights of the insurance companies to support or oppose the Obamacare repeal. Read More

Conflict of Interests Disclosures Come to PubMed

By Christopher Robertson

Scholars and policymakers have long been concerned that the biomedical science literature — and thus the practice of medicine — is biased by the companies who fund research on their own products.  Prior research has shown that industry-funded studies tend to produce results favorable to their company sponsors.  One solution is disclosure of industry funding, so that physicians and other consumers of the biomedical literature can weigh scientific findings accordingly.

My prior work with Aaron Kesselheim, Susannah Rose, and others has found that adding such disclosures to biomedical abstracts could make a big difference — physicians understand them and will rely upon them.  Nonetheless, most journals bury the disclosures at the end of articles, which are often hidden behind paywalls and not nearly as salient as the methods and findings displayed in the abstract.  For the Institutional Corruption Lab of the Edmond J. Safra Center, I worked with a team of hackers to create a browser extension that proves the feasibility of adding those disclosures into PubMed, a Federal government database of the scientific literature.

Thankfully, that browser extension is becoming obsolete, as the National Library of Medicine (part of the NIH) has begun implementing such disclosures themselves, right in PubMed.   A search reveals that nearly 80,000 abstracts now have such tags.  While a lot in absolute terms, it is a small minority of the 17 million abstracts covered by PubMed.  Commentators have suggested that as much as 70% of the funding for clinical trials comes from industry, so we should expect millions of abstracts to have such disclosures.

Thus we are still a long way from comprehensive and effective disclosure.  There are two problems. Read More