Mylan Announces Generic EpiPen; Baffles Health Policy Wonks Everywhere

For weeks now, the list price of Mylan’s EpiPen ($600 for a two-pack) has been exhaustively covered by journalists, debated by academics, and skewered by policymakers as an example of the pricing excesses of even generic pharmaceutical companies.  Mylan’s latest response to the outrage?  Announce that soon, it will be launching a generic EpiPen at a list price of $300 for a two-pack.  I and others who study these issues full time cannot understand why Mylan thought this would work to quell the widespread indignation over its pricing practices.

The first red flag came when Mylan stated it would launch the product “in several weeks.”  I often find myself defending the FDA against charges that it is too slow to approve new technologies, but let’s face it: it would be shocking news if they were able to approve a new version of anything in just a few weeks.  Mylan has not had this in the works for months, so it seems that the new generic product is literally identical to the branded EpiPen – just with a different label.  So, essentially, Mylan is preparing to cut the price of its product in half.  (Even though that’s still higher than the price was just three years ago, before Mylan began its regular price hikes, and even though this should make us question their justifications for the $600 price.) Great, right?  Not so fast.

What reasons (other than public relations) might Mylan have for introducing an authorized generic of this type and how might they attempt to use the two products to maintain their current level of revenues?  By bringing the first generic EpiPen to market, Mylan has now planted its flag in the generics space.  Although epinephrine (the drug inside the EpiPen) is now generic and cheap to produce and sell, companies do seem to find it difficult to replicate the device portion of the EpiPen, with Sanofi’s product recently removed from the market due to dosing issues and Teva’s application for a generic denied by the FDA with no public explanation just a few months ago.  Mylan has now benchmarked a new price for those products if they return – they must price below $300 for a two-pack to compete effectively with Mylan. Continue reading

Ameet Sarpatwari on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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twihl 5x5Our guest this week is Ameet Sarpatwari, an Instructor in Medicine at Harvard Medical School and an Associate Epidemiologist at Brigham and Women’s Hospital based in the Program On Regulation, Therapeutics, And Law (PORTAL) within the Division of Pharmacoepidemiology and Pharmacoeconomics. Ameet’s research focuses on the effects of laws and regulations on therapeutic development, approval, use, and related public health outcomes. He is currently examining the public health implications of variation in state drug product selection laws, the risk of re-identification under HIPAA pathways for data sharing for post-approval drug research, and the comparative safety and effectiveness of biosimilars.In the lightning round, Nic addressed the Notice Act and ongoing controversy over hospitals’ use of “observation status” to dodge readmissions penalties and game reimbursements. We also mentioned the strange politics of bill naming. (One also wonders what exactly vulnerable patients are supposed to do once they receive notice that they could soon be hit by huge bills.)

Nic also covered the FTC’s reversal of an ALJ’s judgment in LabMD, the case that keeps on giving. Frank riffed on an article “Medicaid Expansion’s New Cost Estimate Isn’t Alarming,” from the CBPP, and expressed some skepticism as to the degree to which episode payment models would assure better pay for hospital care.

Our conversation with Ameet focused on his many articles on counter-detailing, medical research ethics, the opioid crisis, and large firms’ misues of the FDA’s regulatory system. Links to all are available at his website.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. 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 @FrankPasquale @WeekInHealthLaw

Ambulances are Monopolies — and They Should Be Regulated Accordingly

By Shailin Thomas

You go to your local urgent care with a headache and a fever, and the doctor suggests a trip to the hospital for further evaluation — just to make sure there isn’t anything serious causing your symptoms. She offers an ambulance, and you accept. You could probably walk or Uber, but you’re not feeling well, and the doctor has offered to arrange the ride. Why not?

This was the story of Joanne Freedman. She didn’t think too much about it, until she received a $900 bill for the two-block ambulance ride she took to the hospital. While Joanne’s experience was particularly egregious, it is not wholly uncommon. Ambulance pricing is one of the most variable and least transparent components of health care costs, with rides ranging from tens to thousands of dollars. This is in part because there are many ambulance providers, and they all have different relationships with different insurance companies. It’s also in part because ambulance rates are generally set according to the services the ambulance is equipped to provide, not necessarily the services actually provided. Some ambulance companies have contracts with municipalities that make them the only game in town, while others are in more diverse markets with multiple providers competing for patients. All this combines to create an incredibly complex industry with very little consistency from ambulance to ambulance.

But is this disjointed, free-market system the best way to structure emergency transportation? The arguments underlying the justification of a free, unregulated market hinge on the ability of consumers to police the industry through choice. If the seller of a good sets the price too high, consumers will buy from a different seller until she brings the price down to what consumers are willing to pay.  This is, in theory, what allows markets to find the right prices for goods and services more efficiently than any government agency or regulator ever could. Continue reading

Drug Pricing, Shame, and Shortages

By Nicholson Price

Drug prices have been making waves in the news recently.  The most recent case is the huge price hikes of the EpiPen, which provides potentially life-saving automatic epinephrine injections to those with severe allergies.  Mylan, which makes the EpiPen, has raised its price some 450% over the last several years.  The EpiPen is a particularly problematic—and media-friendly—story because the emblematic use case is the kid in school who can’t breathe because she came into contact with peanuts.  Jacking up the price on something that’s not optional—for parents and for schools—seems heartless.  Thoughtful pieces have pointed out how the EpiPen price increases demonstrate problems with our health care system and drug/device approval system in general.

Other big recent cases that have hit the news include huge increases in the price of insulin, and, of course, Turing Pharmaceuticals’/Martin Shkreli’s ~5000% price hike on the drug Daraprim.  The EpiPen and Daraprim are especially notable because patents mostly aren’t involved—the effective monopoly appears to come from the delay or challenge in getting generic products approved by FDA (although the EpiPen itself also seems tough to make).  And, of course, drug prices aren’t regulated in the US the way they are in much of the world.

These stories seem crazy, cruel, and fascinating.  And they raise (for me, anyway) the question: what’s changed?  This seems like a relatively new phenomenon.  But FDA’s had a backlog for a while, and drug prices have long been unregulated. Continue reading

Back to School Special Part 3 on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Listen here!

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It’s that time of year again–the TWIHL Back to School Specials (BTSS)! We’ve rounded up experts from across the health law academy to discuss what they see as the most important new developments over the past year in health law, and how to integrate them into the health law curriculum. We’ll have three installments of the BTSS.

In our third and final Back to School Special, Nic Terry discusses Chanko v. ABC and recent HHS-OCR enforcement. Nick Bagley discusses House vs. Burwell and the 3Rs of health insurance. Elizabeth Weeks Leonard discusses the 60 day rule, increased civil penalties and Escobar. Nic focused on health privacy in his discussion, leading off with the fascinating (if tragic) case of Chanko v. ABC (which involved the broadcasting a patient’s death on a television program). He also explained the important NY-Presbyterian Resolution Agreement and the Advocate Health Care Resolution Agreement. Liz covered some complex developments in health care fraud and abuse regarding reporting of overpayments. She also explained recent inflation adjustments to civil monetary penalties. In addition to discussing lawsuits by health insurers over nonpayment of certain funds that appeared to be promised by the ACA, Nick also analyzed yet another of the ACA’s seemingly endless string of legal challenges: House v. Burwell, which refused to infer an appropriation in the ACA for Section 1402 reimbursements to insurers.

Many thanks to Nick, Liz, and our other BTSS experts!

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. 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 @FrankPasquale @WeekInHealthLaw

The Evolving Crisis of the ACA Exchange Marketplace

By Zack Buck

Following news last week that Aetna was pulling out of health care insurance exchange markets in eleven states, Pinal County, Arizona became the epicenter in the rapidly evolving and growing crisis facing the Affordable Care Act’s insurance exchanges.  Sandwiched between Phoenix and Tucson, Pinal County is home to about 400,000 residents, but no insurance companies; in short, Pinal County has been left without any insurance companies signed up to sell insurance on the exchange to its residents for 2017—becoming the “county that Obamacare forgot.”

Pinal County had nearly 10,000 citizens sign up on the exchange in 2016, but Aetna’s departure bookends a rough period for Pinal County residents.  In addition to Aetna, the county has recently endured the departure of UnitedHealth Group, Humana, and a non-profit co-op from Arizona’s exchange.  As a result, Pinal County is reportedly looking to other insurers who may be interested in selling on the exchange to its residents; in a bit of hopeful news, Blue Cross Blue Shield of Arizona is said to be “re-evaluating where it will offer plans next year.”

But the crisis isn’t contained to Pinal County.  Two states—Tennessee and Alaska—have been trying to avoid a similar fate.

Continue reading

Trap for the Unwary: Records compiled by a hospital’s risk-management specialist held discoverable

By Alex Stein

In a recent case, Frankfort Reg. Med. Ctr. v. Shepherd, 2016 WL 3376030 (Ky. 2016), the Kentucky Supreme Court held that the attorney-client privilege and its work-product extension do not protect records compiled by a hospital’s risk-management specialist. Records that the Court held to be discoverable contained information pertaining to a baby delivery that went badly. The risk-management specialist gathered that information with an eye on a possible medical malpractice suit, but her primary goal was risk management (which presumably precluded the applicability of the “subsequent remedial measures” privilege).

The Court’s decision relied on the familiar “dominant purpose” test, under which the attorney-client privilege only covers documents compiled primarily in preparation to litigation. Understandable as it may be from a purely doctrinal viewpoint, this decision makes no economic sense. All it does is create a trap for the unwary and an opportunity for hospitals familiar with the law to protect their risk-management information against disclosure. To obtain the needed protection, all that a hospital needs to do is ask its in-house counsel or outside attorney to control the risk-management procedures and decisions, so that risk management becomes part of the attorney’s work as a protector of the hospital’s legal interests. Doing so isn’t difficult but costlier than simply relying on a risk-management consultant.

Rawlsian Questions about CRISPR Gene Editing

By Kelly Dhru

We worship perfection because we can’t have it; if we had it, we would reject it. Perfection is inhuman, because humanity is imperfect. – Fernando Pessoa, The Book of Disquiet.

Pessoa may have had an “I told you so!” moment looking at the ethical debates over CRISPR-Cas9, which is the technology that has made the alteration of genomes easier. As we march towards fundamentally altering the code that governs our bodies, it is this very walk towards perfection that seems to scare us.

To start with, not enough can be said about the importance of CRISPR-Cas9, which is one of the most important scientific advances of our times. Because of this technology, we are now looking at the ability to combat some previously “incurable” genetic disorders. This technology is also opening up doors to tackle malaria, Zika and dengue fever in innovative ways and to potentially find a cure for cancer. Continue reading

Sovereign Immunity Protects State-Owned Hospitals and Medical Personnel Against Malpractice Suits

By Alex Stein

Pike v. Hagaman, — S.E.2d —- 2016 WL 3097727 (Va. 2016), is a must-read for anyone interested in medical malpractice and health law. This new decision of the Virginia Supreme Court grants state-owned hospitals and their personnel categorical sovereign-immunity protection against medical malpractice suits. Continue reading

The School To Prison Pipeline Undermines the Dignity of Children and Also Society

Madisyn Moore

Madisyn Moore, handcuffed at school and left for an hour unattended.  Her mother is now suing.

Co-authored with Eliana Grossman.

By all accounts the U.S. drug war has failed: more drugs are sold on black markets, streets, and in alleys than before, trillions of dollars have been spent, and millions of non-violent offenders are now locked away.  Some men and women will be incarcerated for the rest of their lives for non-violent drug crimes.

However, in wake of the drug war and robust mass incarceration, the pattern of policing has trickled down to children.  The “school to prison pipeline” is more than a euphemism.  It describes zero tolerance policies, subjective discipline, suspensions, and expulsions.  Most disturbingly, it describes a process that starts for some kids as young as five and six years old.

In our recent Huffington Post article, we describe how Madisyn Moore, a six year old, African American, was handcuffed behind a dark stairwell for more than an hour by a school guard who mistakenly believed the little girl stole a piece of candy.  In defending his actions, the guard claimed, “‘I’m teaching her a f — -g lesson. She took a piece of candy and I handcuffed her under the stairs.’”  It turns out the Madisyn’s mother packed the treat for her daughter.  The guard was later fired, but the trauma Madisyn experienced will likely last for a long time. Continue reading

Policy Surveillance: A Vital Public Health Practice Comes of Age

In a new article published today in the Journal of Health Politics, Policy and Law, Scott Burris, Laura Hitchcock, Jennifer Ibrahim, Matthew Penn and Tara Ramanathan make the case for the practice of policy surveillance to improve public health.

Though widely used, legal “treatments” for public health promotion and protection are too often applied to large populations without timely evaluation or even systematic monitoring. When we implement programmatic interventions in health, we demand evaluation. We should demand no less for legal interventions.

Policy surveillance can help end the inconsistent treatment law receives in public health research and practice. Policy surveillance is the systematic, scientific collection and coding of important laws of public health significance. Continue reading

Still Seeking Contraceptive Compromise After Zubik v. Burwell

[Crossposted from RegBlog]

By Allison Hoffman

Zubik v. Burwell was this year’s Affordable Care Act (ACA) appearance on the Supreme Court stage. Consolidated with six other cases, Zubik challenged the ACA requirement that group health plans and health insurance issuers must provide free coverage of preventative services, including all contraceptive methods approved by the U.S. Food and Drug Administration (FDA).

Some religious groups believe that the use of some or all contraceptives is morally wrong. In response, the initial preventive services regulation exempted houses of worship, such as churches, from the requirement altogether. For religious nonprofit organizations, such as universities and hospitals, later regulations created an accommodation that enabled employees to receive coverage for contraceptives without the employer having to provide it.

Even though the U.S. Department of Health and Human Services (HHS) has tried to make it easy for nonprofit organizations to receive the accommodation, it still requires those organizations, unlike churches and other houses of worship, to ask for it affirmatively through a process of self-certification. Continue reading

Back to School Special Part 2 on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Listen here!

twihl 5x5

It’s that time of year again–the TWIHL Back to School Specials (BTSS)! We’ve rounded up experts from across the health law academy to discuss what they see as the most important new developments over the past year in health law, and how to integrate them into the health law curriculum. We’ll have three installments of the BTSS.

This is our second episode, and you’ll see why we love acronyms so much once you hear Frank’s discussion of MACRA’s Merit-based Incentive Payment System (MIPS) and Advanced Payment Models (APMs). For an introduction to MACRA, check out resources linked to here and here and here. We are also pleased to have two great returning guests for this BTSS: Leo Beletsky discusses the opiate crisis and the curative but unfunded mandateErin Fusee Brown discusses Universal health Services v. U.S., ex rel. Escobar, the case that may launch a thousand (or more) false claims litigations.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. 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 @FrankPasquale @WeekInHealthLaw

Back to School Special Part 1 on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Listen here!

twihl 5x5

It’s that time of year again–the TWIHL Back to School Special (BTSS)! We’ve rounded up experts from across the health law academy to discuss what they see as the most important new developments over the past year in health law, and how to integrate them into the health law curriculum. We’ll have three installments of the BTSS; this episode is the first.

This episode features three scholars at the cutting edge of contemporary health law. Allison Hoffman discusses Gobeille v. Liberty Mutual Insurance and Zubik v. Burwell–and offers big picture commentary on the ways employer-sponsored insurance create unique dilemmas for American law. Nicole Huberfeld discusses Whole Women’s Health v. Hellerstedt and Medicaid expansion. Abbe Gluck describes a new “book course” approach to teaching health law, and the importance of health law perspectives in constitutional law and federal courts courses.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. 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 @FrankPasquale @WeekInHealthLaw

Please, Boston Nonprofit Hospitals, Can’t You Join Forces Instead Of Competing?

[Crosspost that originally appeared on WBUR’s CommonHealth]

By Michael Anne Kyle and Lauren Taylor

Here in Boston, cooperation between health care providers is a fraught issue.

Competition is fierce among local, not-for-profit teaching hospitals, and the idea of collaboration brings to mind collusion, mergers and monopolies.

Unfortunately, these concerns may be keeping Boston hospitals from pursuing cost-effective strategies to meet federal tax-exemption requirements and improve community health. Over the next year, each of Boston’s 12 hospitals will have to conduct a community health needs assessment (CHNA) to retain their tax-free status. New requirements in the Affordable Care Act specifically encourage collaboration between hospitals and with other health care agencies, such as public health departments.

We argue that doing one, citywide CHNA presents a rare opportunity for high-value, low-commitment coordination among Boston hospitals. Continue reading

Income-Scaling of Cost-Sharing Gains Traction

With 148,000 members, the American College of Physicians (ACP) is the largest medical-speciality organization.  This summer, its board released a new report on the growing financial burdens faced by patients who enjoy health insurance but are nonetheless exposed to unbearably large costs for healthcare.  At the end of the day, cost-sharing is just the absence of insurance for those costs.

ACP calls for a range of reforms, including “income-adjusted cost-sharing approaches that reduce or directly subsidize the expected out-of-pocket contribution of lower-income workers to avoid creating a barrier to their obtaining needed care.”  As I have argued, the Affordable Care Act includes income-based subsidies for cost-sharing in the Marketplaces, but these are currently being challenged in court, and do not apply to the employer-based system or Medicare, which together cover the vast majority of patients.

Hillary Clinton has also advanced a plan to create progressive refundable tax credits for people who spend more than 5% of their income out-of-pocket.   The advantage of such a tax-based approach is that it reaches patients regardless of where they get their insurance (except for Medicare, which is excluded).  The disadvantage is that it leaves people in a state of financial insecurity until they get their refunds.  A better approach would scale cost-sharing exposure in the first place, a power that I have suggested is already available under Federal law and which is self-funding.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

Below are the papers identified from the month of July. The selections feature topics ranging from the reporting of clinical trial subgroup effects in top medical journals, to an assessment of generic drug approvals since the 1984 Hatch-Waxman Act, to the impact of proposed Medicare Part D reforms on cancer drugs. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Gabler NB, Duan N, Raneses E, Suttner L, Ciarametaro M, Cooney E, Dubois RW, Halpern SD, Kravitz RL. No improvement in the reporting of clinical trial subgroup effects in high-impact general medical journals. Trials. 2016;17(1):320.
  2. Gagne JJ, Han X, Hennessy S, Leonard CE, Chrischilles EA, Carnahan RM, Wang SV, Fuller C, Iyer A, Katcoff H, Woodworth TS, Archdeacon P, Meyer TE, Schneeweiss S, Toh S. Successful comparison of US Food and Drug Administration Sentinel analysis tools to traditional approaches in quantifying a known drug-adverse event association. Clin Pharmacol Ther. 2016 Jul 14. [Epub ahead of print].
  3. Gupta R, Kesselheim AS, Downing N, Greene J, Ross JS. Generic Drug Approvals Since the 1984 Hatch-Waxman Act. JAMA Intern Med. 2016 Jul 18. [Epub ahead of print].
  4. Haffner ME. The history of orphan drug regulation – US and Beyond. Clin Pharmacol Ther. 2016 Jul 9. [Epub ahead of print].
  5. Hoekman J, Klamer TT, Mantel-Teeuwisse AK, Leufkens HG, De Bruin ML. Characteristics and follow-up of postmarketing studies of conditionally authorized medicines in the EU. Br J Clin Pharmacol. 2016;82(1):213-26.
  6. Luo J, Kesselheim AS. Protecting Pharmaceutical Patents and Test Data: How the Trans-Pacific Partnership Agreement Could Affect Access to Medicines in the US and Abroad. AMA J Ethics. 2016;18(7):727-35.
  7. Mailankody S, Prasad V. Implications of Proposed Medicare Reforms to Counteract High Cancer Drug Prices. JAMA. 2016;316(3):271-2.
  8. van Staa TP, Goldacre B, Buchan I, Smeeth L. Big health data: the need to earn public trust. BMJ. 2016 Jul 14;354:i3636.