• The D.C. Circuit boots another ACA lawsuit.

    This morning, the D.C. Circuit rejected West Virginia’s challenge to the so-called “like it, keep it” fix, which told the states that they could temporarily decline to enforce the ACA’s new insurance rules against their insurers. (Background here.)

    I’m sympathetic to West Virginia’s underlying legal claim. It was unlawful, in my judgment, for the Obama administration to effectively waive the ACA’s insurance rules. But I’ve always thought that the state lacked standing to bring the case.

    West Virginia’s standing theory is a little complicated. It believes it suffered a constitutionally cognizable injury because state officials had to decide whether to allow their insurers to take advantage of the administrative fix. Forcing those state officials to decide put them in an uncomfortable political position—so uncomfortable to amount to an injury. I didn’t buy it:

    For all practical purposes, West Virginia faced the same choice before and after the administrative fix: whether to use state resources to enforce the ACA. And it was a bona fide choice: prior to the fix, insurance commissioners in six states had announced they wouldn’t enforce the statute.

    All the administrative fix did was change the political stakes of a non-enforcement decision. But that sort of shifting-the-political-stakes claim doesn’t tend to fare well in standing analysis. It’s too speculative—too non-concrete—to license federal courts to referee what is, even in West Virginia’s telling, essentially a fight about political optics.

    This morning, the D.C. Circuit agreed. The relevant language is below:

    Although [West Virginia] dresses up its argument as a breach of State sovereignty in violation of the Tenth Amendment, its injury is nothing more than the political discomfort in having the responsibility to determine whether to enforce or not—and thereby annoying some West Virginia citizens whatever way it decides. And no court has ever recognized political discomfort as an injury-in-fact. We do not doubt that West Virginia now confronts different political terrain than it did before HHS announced its new non-enforcement policy. But we do not think that represents cognizable legal injury. Increased political accountability of this nature—greater likelihood of political consequence in making a decision—is the kind of inherently immeasurable harm that our standing doctrines have been designed to screen out. Time, and time again, it has been stressed that an injury must be “concrete.”

    Good riddance to a politically motivated lawsuit that should never have been brought. If I were the House of Representatives, I’d be a little nervous. The D.C. skepticism here doesn’t bode well for House v. Burwell—another politically motivated case premised on a novel standing theory.

    @nicholas_bagley

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  • Delaying the risk corridor lawsuits

    Last week, the Department of Justice asked the Court of Federal Claims to dismiss a massive class-action lawsuit in which co-ops have asked for money owed to them under the risk corridor program.  To my knowledge, the government’s motion is its first substantive filing in any of the risk corridor cases.

    The litigation was precipitated by dramatic shortfalls in risk corridor payments for the 2014 benefit year. Co-ops were hit especially hard when the government broke its promise to make up some of their losses, which were much larger than anticipated. (Background here, here, and here.)

    In its motion, the Justice Department doesn’t contest that it may someday owe the health plans money under the risk corridor program. Instead, the government says that it doesn’t owe them that money now. The risk corridor program runs from 2014 to 2016, which means that surpluses in years 2015 and 2016 may be sufficient to cover shortfalls in 2014 payments. Only when the program has run its course can co-ops know for certain whether they haven’t been paid what they’re owed.

    In other words, the lawsuit may one day be viable—but it’s been brought too soon. And it’s not just that the case is unripe, the federal government says. Under the Tucker Act, the Court of Federal Claims doesn’t even have jurisdiction to hear it because the money isn’t “presently due.”

    The health plans are likely to push back. They’ll argue that the federal government has in fact promised to make risk corridor payments annually. To figure out who’s right, you’ve got to take a close look at the ACA and HHS’s regulations implementing the risk corridor program. Do they require annual payments, as the co-ops apparently believe? Or can they be read to allow a final payout at the end of the three-year program?

    My tentative view is that HHS has the better argument. As the government explains:

    [The ACA] requires CMS to calculate risk corridors payments and charges based on claims and other costs for a “benefit year,” but it does not require CMS to pay risk corridors on an annual basis. Likewise, while [the implementing regulation] requires issuers to pay charges within 30 days of notification by CMS, it does not establish any deadline by which HHS must make payments to issuers. … In the absence of a contrary statutory provision, “agencies, not the courts, . . . have primary responsibility for the programs that Congress has charged them to administer.” … HHS exercised this discretion by establishing a three-year payment framework.

    That seems right to me, but I’ll be curious what the co-ops have to say in response.

    The important point is that the federal government isn’t taking a “sue and settle” approach to the risk corridor litigation. The feds are fighting—for now. And they will keep fighting at least through the summer of 2017, when they receive the data from health plans to make their final risk corridor calculations.

    @nicholas_bagley

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  • AcademyHealth: How do we make posts interesting?

    Aaron and I have been posting on the AcademyHealth blog about how we turn academic papers into interesting blog posts. We’ve already posted on how we read papers and how we decide what to write about. Our third post, now live, covers how we make blog posts interesting.

    @afrakt

     

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  • Stuff for Healthcare Systems (PHMD2350)

    What is this post about? Look here.

    @afrakt

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  • Physician, review thyself!

    Dan Ho and Becky Elias have a wonderful article in the Boston Review about their new research on the benefits of peer review in restaurant inspections.

    Beginning in 2014, we designed a randomized, controlled trial to test the effectiveness of peer review with the food safety staff of King County, where Seattle is located. Half of the inspection staff was randomly assigned to engage in peer review. For sixteen weeks, these inspectors spent one day per week with a randomly selected fellow inspector, taking turns conducting inspections and independently scoring health code violations. We then used information from these peer inspections to identify and train for violations that cause the most confusion.

    The results were remarkable. We discovered that, when observing identical conditions in restaurants, health inspectors disagreed nearly 60 percent of the time. Inspectors differed in their assessments of risk magnitude and in interpretations and applications of the health code to particular circumstances, resulting in varying citations for the same condition. Food science is evolving, and the FDA model food code spans nearly 800 pages, so it may not be surprising that implementation varies so much. As one inspector put it, “In the beginning, we [thought] we kn[e]w the code,” but comparing assessments with others provided a “wake-up call.”

    A bona fide randomized controlled trial of a government program in a real-world setting? This is rare and exciting stuff, with enormous resonance for public administration and administrative law. (The full research paper will soon be published at the Stanford Law Review.)

    It’s also relevant to medicine. If peer review works for restaurant inspections, might it also work for health care? As with restaurants, similar patients are often treated differently depending on who treats them and the norms that prevail in the community. Practice guidelines can moderate that variation, much like the FDA model food code. But guidelines can’t tell you how to deal with atypical cases and they aren’t always followed anyhow. Stitching peer review into medical practice might promote consistency while honoring the clinician’s imperative to attend to the idiosyncrasies of particular patients.

    To some extent, peer review has always been a part of medicine—think here of M&M conferences. And it’s starting to get more attention. As Ho and Elias note, Atul Gawande wrote an important New Yorker article in 2011 about surgical coaching. Here at the University of Michigan, Justin Dimick has landed an NIH grant to investigate surgical coaching more generally.

    The Ho and Elias study makes me cautiously optimistic about efforts like these. Peer review might or might not work as well for hospitals as it does for restaurants. But it’s certainly worth exploring.

    @nicholas_bagley

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  • Healthcare Triage: Retail Clinics are Convenient, Reliable, and Kind of Affordable

    Aaron and his wife both work. When one of their kids wakes up complaining of a sore throat, they begin a ritual staredown to determine which of them is going to have to wait for the doctor’s office to open, call them, wait on hold, schedule an appointment (which will inevitably be in the middle of the day), take off work, pick the kid up from school, wait in the waiting room (surrounded by other sick kids), get seen, get the rapid strep test, find out if the kid is infected, and then take them to the pharmacy or back to school, before returning to work.

    Or, one of them could just take the kid to a retail clinic on the way to work/school and be done in 30 minutes.

    The undeniable convenience and reliability of retail clinics is the topic of this week’s Healthcare Triage:

    This was adapted from a column I wrote for the Upshot. Links to sources and further reading can be found there.

    @aaronecarroll

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  • The cost of low vaccine prices

    The following originally appeared on The Upshot (copyright 2016, The New York Times Company).

    A $30,000 price tag for cancer drug therapy that extends life only a few weeks is understandably alarming. But a $2,000 price tag for all childhood vaccines — credited with eradicating smallpox, preventing a million or more cases of other diseases and averting thousands of deaths each year — is a bargain. In fact, the price of childhood vaccines may be too low for our own good because it contributes to shortages.

    Vaccine shortages have popped up in the United States many times over the past 50 years. In 2001, eight of 11 recommended childhood vaccines were unavailable or in short supply. A recently published study by the economist David Ridley and other Duke University researchers found that between 2004 and 2014, an average of nearly three out of 22 vaccines were in short supply in the United States. In 2007, one-third of vaccines were. (Looking globally, limited vaccine supplies hampered the response to a recent yellow fever outbreak that began in Angola and spread elsewhere.)

    Vaccine prices have gone up over the years, in large part because of newer vaccines that command higher prices. The number of recommended vaccine doses has also increased, which pushes up the overall cost of full vaccination. Still, vaccines are inexpensive relative to their value. A typical dose costs $50 and, apart from an annual flu shot, only a few doses are required over a lifetime. According to the Duke study, vaccines with lower prices were more likely to be in short supply than those with higher prices. There were no shortages of vaccines with a price per dose above $75.

    Low prices are implicated in vaccine shortages, just as they are for other injectable drugs delivered in hospitals and doctors’ offices. Generic injectables used for patients with serious illnesses and in emergencies also have low prices that contribute to shortages. But vaccines, unlike such injectables, are not generic. Vaccines are brand biologics (large-molecule, protein-based drugs made by living organisms, not by chemical processes), which normally command very high prices. So why are their prices low instead of high?

    Vaccine prices are held down by government programs, which extendvaccinations to millions of children who might not otherwise get them. Federal and state programs buy more than half of childhood vaccine doses at a discount. The largest federal vaccine program — Vaccines for Children— may adjust prices within a year, but only downward, and it constrains changes in what it pays for some vaccines to below the overall inflation rate. Though the program keeps a six-month backup supply of vaccines on hand, the average shortage lasts three times that long, according to the Duke study.

    Commercial market vaccine prices are higher than government ones, but not by enough to prevent shortages.

    Low prices and concentrated buying power in government programs have pushed redundancy out of the market. There are only a few vaccine manufacturers, and some vaccines — including those for measles, mumps, rubella, varicella and shingles — are produced by just one. With little excess capacity, when a manufacturer experiences a problem requiring a shutdown, vaccine production falls below needed levels, causing a shortage. It can take years and close to a billion dollars to bring a new vaccine to the market, hardly a recipe for rapidly addressing a shortage.

    “Manufacturers won’t invest in extra production capacity when prices are too low,” Mr. Ridley said.

    Vaccines are among the most cost-effective treatments ever developed. Though most medical treatments don’t save money, vaccines do — preventing many diseases that would cost more to treat and allowing millions of people to live longer and more productive lives. Several studies have found that at even at 10 times their cost, vaccines would still save money.

    We probably don’t need to raise vaccine prices by a factor of 10 to promote new vaccine investment and stabilize supply. According to one study, a doubling in price would incentivize new vaccine research, development and production.

    For drugs as valuable as vaccines, that might be a price worth paying.

    @afrakt

     

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  • Sexual harassment and public shaming in the academy

    Is it ever okay to publicly shame someone on the internet? There are many cases where people have been persecuted online, and suffered severe consequences, based on accusations that are either trivial or false. But there may also be cases where public humiliation is merited, indeed, it may be the only way to address a grievous wrong. A letter accusing a prominent professor of sexual harassment is an important test case.

    Thomas Pogge is the Leitner Professor of Philosophy and Professor of Political Science at Yale. Pogge has been accused of serial sexual harassment in an Open Letter signed by scores of his academic colleagues:

    Pogge has engaged in a long-term pattern of discriminatory conduct, including unwanted sexual advances, quid pro quo offers of letters of recommendation and other perks, employment retaliation in response to charges of sexual misconduct, and sexual assault. [There are also] affidavits from former colleagues at Columbia University, who attest that Pogge was accused of sexual harassment by a student in his department, and disciplined for this.

    Workplace sexual harassment is a serious form of wrongdoing, but it’s very common. So what makes this case news? It may be the identity of the accused. Pogge is an internationally famous political philosopher. He is an egalitarian, best known for having extended the work of his teacher, John Rawls, to issues of global justice. Sexual harassment, if he is guilty of it, is a striking betrayal of his public commitments to justice.

    The Open Letter has an option for other academics to co-sign. I’ve spent a surprising amount of time considering whether I should.

    The reason not to sign is that “trial by internet” is problematic.* There’s no due process or rights for the accused. Yale has an administrative procedure for handling harassment complaints and there is a way to get justice in the courts under Title VII of the Civil Rights Act. And, of course, not everything that you read on the internet is true. I was deeply shocked when I read the Rolling Stone article about the supposed gang rape at the University of Virginia, and shocked again when it was retracted.

    But this case may be different. There are several witnesses testifying about their victimizations. Fernanda Lopez Aguilar, a former Yale undergraduate, has alleged that Pogge sexually harassed her while she worked as his research assistant. (Pogge responds to her here.) There are also allegations by an anonymous graduate student, the philosopher Delia Graffi Farra, and the philosopher Erin Kelly.

    Moreover, although I do not know Pogge personally, many of the authors of the Open Letter do. They include many leading moral philosophers, including other former students of Rawls (Elizabeth Anderson, Barbara Herman, and Joshua Cohen), and Pogge’s Yale colleagues Shelley Kagan and Stephen Darwall (chair of the Yale Department of Philosophy). In many cases of sexual misconduct, there is an ‘old boy’ network that seeks to hide the scandal and protect the institution. Not this time.

    Pogge’s colleagues are also concerned that

    bringing the complaint to resolution will be a long and complex process focused more on Yale’s handling of these claims, rather than on the specific allegations against Pogge. Meanwhile, the academic community must make its own decision about how to respond in light of what has been made public. We write, then, to express our belief that the information now in the public domain — including that provided by Pogge himself… — suffices to demonstrate that Pogge has engaged in behavior that violates the norms of appropriate professional conduct.

    In short, Pogge is being read out of the community of ethics scholars. But I think that the authors of the Letter are concerned with more than Pogge. There is significant evidence that philosophy can be a particularly hostile environment for women (see accounts here, and the case of Colin McGinn). The authors may be hoping to reset the norms governing the treatment of women in philosophy and, perhaps, university faculties generally.

    Finally, if we can’t judge others’ behaviour because we lack perfect instruments for determining the truth, we will never make or signal our moral judgments. Similarly, if we required that judicial proceedings be perfect instruments of truth, we would have no courts.

    I signed the letter.


    *I also have a concern about personal consistency when I stand in the crowd judging Pogge. What’s the metric that makes me a better person him? No, I haven’t sexually harassed (or cheated on, or assaulted!!!) anyone. But I can list many principles that I endorse in theory and betray in practice. For example, I believe:

    1. That animal lives count. Yet I am a lapsed vegetarian.
    2. That global warming is a serious threat. Yet I log a lot of air miles.
    3. That current social and economic inequality is excessive. Yet I live in the North American 1% and have no plans to leave it.
    4. [The list is indefinitely long.]

    If I’m unfaithful to my professed beliefs, do I have standing to criticize Pogge?**

    **[Releasing my inner David Foster Wallace, here’s a footnote to my footnote.] As we put Pogge into the stocks on the Commons, we need to ask ourselves whether we are the judges in The Scarlet Letter or The Crucible. Who are we to judge when we are, as Jonathan Edwards said, Sinners in the Hands of an Angry God?***

    ***And yet, if we can’t judge until we ourselves are perfect, there will be no moral progress.

    @Bill_Gardner

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  • Interesting synonyms

    Via Dan Diamond:

    blogable

    @afrakt

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  • #6Things That Happened in Health Policy This Week

    6 Things That Happened in Health Policy This Week is produced by a mix of research assistants from the Healthcare Quality & Outcomes (HQO) Initiative at the Harvard T.H. Chan School of Public Health. In each edition we feature a variety of news articles, reports, and studies focused on U.S. health policy and health services research. This week’s edition is from Yevgeniy Feyman (@yfeyman), Zoe Lyon (@zoemarklyon) and Raj Pammal (@rspammal). 

    KHN: House Republicans Unveil Long-Awaited Plan to Replace the ACA

    • House Republicans have finally delivered on their promise to unveil a plan to replace the ACA— “A Better Way,” a 37-page white paper was released this week and includes a massive slew of health policy ideas repeatedly proposed by Republicans.
    • “A Better Way” would bring back high risk pools, would end open-ended funding for Medicaid, and would encourage small business to band together to increase bargaining power.
    • The white paper includes no specifics about how much any of this would cost or how it would be financed. There is also no mention of what would happen to the 20 million Americans who have gained coverage since the law took effect in 2010.
    • Along with huge cuts to the Medicaid program, the plan would repeal the exchanges and replace them with tax credits given to everyone buying policies in the individual market.
    • The proposal encourages the movement of Medicare beneficiaries out of the FFS service and into managed care plans, and would transition to a “premium support” financing structure that puts the cost-controlling burden more on private insurers.
    • Proponents of the ACA were quick to criticize Speaker Paul Ryan’s plan as recycled ideas to increase costs for seniors and take away health insurance from millions.

    KHN: Despite Overdose Epidemic, Georgia Caps The Number Of Opioid Treatment Clinics

    • In 2014, more than 1,200 people died of an opioid overdose, according to the CDC.
    • In spite of that, Georgia has implemented a one-year moratorium (which began June 1st) on issuing new licenses to clinics that treat people addicted to opioids.
    • Georgia State Senator Jeff Mullis, who sponsored the legislation implementing this moratorium, questions why a large number of opioid treatment programs have opened in Georgia.
      • The state has 67 programs, compared to 12 in Tennessee, 24 in Alabama, and only one in Mississippi.
    • While opening a clinic in Georgia entails multiple licensing requirements from the federal and state governments, but Senator Mullis notes that Georgia doesn’t have a certificate of need requirement for clinics, unlike neighboring states.
      • Certificate of need laws operate in some 36 states, and typically require permission from state governments before opening new healthcare facilities, or expanding existing ones.
    • Critics of these clinics also argue that they simply have patients replace one drug for another.
    • Jonathan Connell, who heads the Opioid Treatment Providers of Georgia, believes that the moratorium is warranted. He argues that regulations of opioid clinics in the state are not well-enforced by the Georgia Department of Community Health.
      • The Department of Community Health has a small workforce of only three people to keep track of the 67 clinics.

    The Hill: New Shots Fired in Drug Pricing War

    • The global drug lobbying group Biotechnology Innovation Organization (BIO) is accusing the Institute of Clinical and Economic Review (ICER) of being a shill for insurance companies.
      • ICER analyzes the cost-effectiveness of various drugs and treatments, and develops recommended prices based on their findings.
      • In a recent analysis of dozens of clinical trials, the group found that many treatments were overvalued at existing list prices.
      • Jim Greenwood, CEO of BIO, has called the group’s results “a completely arbitrary low-balled number.”
    • Drug companies have consistently pushed back against the group’s findings.
    • For the first time, the Centers for Medicare and Medicaid Services (CMS) has said that they may use ICER’s findings to change Medicare Part B reimbursement rates for drugs.
    • ICER receives about 10 percent of its funding from insurance companies, and has a number of prominent executives from insurance companies on its board. Funding from pharmaceutical manufacturers stands at 17 percent, and ICER has plans to add a new former pharmaceutical executive to its board in July.
    • BIO is planning to escalate its efforts against the group including more paid advertisements and “rapid-response.”

    The WSJ: Justice Department Announces Biggest Medicare Fraud Crackdown

    • Attorney General Loretta Lynch announced a historic crackdown on Medicare fraud on Wednesday, with around 300 people being arrested.
    • The charges against the suspects range from taking illegal payments for marketing medications to false physical-therapy claims.
    • Other government programs have been implicated as part of this crackdown as well. In California, a man has been charged with receiving illegal payments from Tricare—a government program for active military members, vets, and their families—for marketing compound medications.
    • In New York City, other suspects included managers of physical therapy clinics that laundered money and billed Medicare and Medicaid for unnecessary treatments for patients.
    • Of most policy relevance is the hemorrhaging of money that comes as a result of the fraud; Lynch cited cases around the country where a wide variety of fraud has been found, with losses totaling around $900 million.

    Modern Healthcare: Senators push Justice Department to halt health insurance mergers

    • Elizabeth Warren (MA-D) and Richard Blumenthal (CT-D) are among seven Democratic U.S. Senators who wrote a letter to the Department of Justice’s antitrust division pressing it to block pending health insurance mega-mergers.
    • Specifically, the letter raised concerns over Aetna’s takeover of Humana, and Anthem’s acquisition of Cigna.
    • The letter stated that the merger of four of the five largest national health insurers would diminish competition, thereby increasing healthcare costs for consumers and business, and decreasing access to quality healthcare.
    • During the Obama administration, the Department of Justice has been quite active in blocking large-scale mergers that may harm consumers and competition.
    • Aetna and Anthem spokespeople countered the senators’ letter, with T.J. Crawford of Aetna affirming the company’s belief that a combined company is in the best interest of consumers.

    New York Times: Medicare and Social Security Trustees Warn of Shortfalls

    • On Wednesday, the Obama administration reported that Medicare’s hospital insurance trust fund (which pays for Medicare Part A benefits and Medicare Program administration) had deteriorated slightly in the past year, and that Social Security still faced serious long-term problems.
    • Trustees projected that Medicare’s hospital trust fund would be fully depleted by 2028, two years earlier than previously expected.
    • Despite claims from Obama administration officials that the Affordable Care Act has slowed the growth of health care spending, the report raised concerns over rising Medicare and Social Security costs, due to accelerating cost growth from the aging of the baby boom generation.
    • Congress took action last year to strengthen Social Security’s disability insurance trust fund, however, it is still estimated that the trust fund will be depleted by 2023.
    • As Medicare is expected to have an increase in average spending per beneficiary from $13,000 to $16,000 in the next five years, leaders from both parties are considering the idea of benefit cuts or tax increases for entitlement programs.
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