• The substance of the ACO antitrust rules

    My summary: If a provider is clinically integrated enough to qualify as a Medicare ACO, that’s good enough for antitrust law too.  From the October 20, 2011 DoJ/FTC joint Final Statement:

    The Agencies have determined that CMS’s eligibility criteria are broadly consistent with the indicia of clinical integration that the Agencies previously set forth in the Health Care Statements and identified in the context of specific proposals for clinical integration from health care providers. The Agencies also have determined that organizations meeting the eligibility requirements for the Shared Savings Program are reasonably likely to be bona fide arrangements intended to improve the quality, and reduce the costs, of providing medical and other health care services through their participants’ joint efforts.

    In other words, familiar health care antitrust rules will apply. As for safe harbors, an ACO will be considered “highly unlikely to raise significant competitive concerns” if institutional providers participate non-exclusively and the combined market share is 30% or less. Behavior the government hopes to discourage includes:

    1. Blocking commercial payers that want to direct or incentivize patients to choose certain providers;
    2. Tying sales of ACO services to sales of other services (ie, the ACO cannot require health plans wanting ACO services to contract with all of provider’s network for non-ACO services);
    3. Contracting with ACO non-primary care physicians, hospitals, ASCs, or other providers on an exclusive basis (only primary care docs can be exclusive);
    4. Restricting a commercial payer’s ability to provide cost and quality performance data and information to its enrollees; and
    5. Sharing sensitive price information amongst competing ACO members.

    All very sensible; as we’ve said before, ACOs raise competitive concerns and don’t need special antitrust exceptions.

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  • Building better doctors

    While the NYT trash-talks legal education, medical schools are revising the MCAT to “reward candidates who have read broadly in the liberal arts and can think analytically.”  This is a change.

    This new focus aims to encourage aspiring physicians to come to medical school having considered what makes us human, how we interact with other human beings, and how human behaviors have shaped civilizations and society.

    That’s from the Dean of the Harvard Medical School, writing in NEJM.

    The MCAT revision complements efforts by some medical schools to reserve a portion of their classes for humanities students who lacked traditional pre-med education as undergrads.  Not to put too fine a point on it, but stellar success as a pre-med may not correlate perfectly with the social skills needed to be an excellent primary care doctor.

    One program, the Mt. Sinai Humanities and Medicine Program, has reported encouraging results:

    Results: There were no statistically significant differences between the groups in clerkship honors other than psychiatry (HuMed students outperformed their peers, P < .0001) or in commencement distinctions or honors. Although HuMed students were significantly more likely to secure a scholarly-year mentored project (P = .001), there was no difference in graduating with distinction in research (P = .281). HuMed students were more likely to have lower United States Medical Licensing Examination Step 1 scores (221 ± 20 versus 227 ± 19, P = .0039) and to take a nonscholarly leave of absence (P = .0001). There was a trend among HuMed students toward residencies in primary care and psychiatry and away from surgical subspecialties and anesthesiology.

    Conclusions: Students without the traditional premedical preparation performed at a level equivalent to their premedical classmates.

    Muller D, Kase N. Challenging traditional premedical requirements as predictors of success in medical school:  the Mount Sinai School of Medicine Humanities and Medicine Program.  Academic Med 2010;85:1378-1383.

    In law schools, the USNews ranking system generally punishes experimentation like this.

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  • Don Berwick resigns

    Per the WaPo.

    Not a surprise, but disappointing still.

    Can any academic to the left of Mark McClellan get confirmed at HHS?



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  • Avastin media scorecard, final edition

    Did the media report the Avastin label revocation correctly?  Predictably, the WSJ Opinion page missed the science boat, but the journalists – NYTimes, Reuters, ABC News, the Boston Globe, and even the WSJ news story – they all covered the essentials.  My only quibble is with the lede for the Globe:

    “The government delivered a blow to some desperate patients Friday as it ruled the blockbuster drug Avastin should no longer be used to treat advanced breast cancer.”

    It wasn’t the government that delivered the blow.  Genentech was the company that marketed a drug for billions of dollars to desperately ill women.  A drug that we now know does not work, according to the best evidence we have at present.  Don’t blame the FDA.

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  • FDA action on Avastin

    Today the FDA Commissioner recommends revoking the Avastin label for metastatic breast cancer. As we’ve said before, the FDA is not:

    • Pulling Avastin from the market;
    • Banning use of Avastin for metastatic breast cancer;
    • Punishing doctors who use it off-label;
    • Banning reimbursement for off-label use; or
    • Making a death panel decision based on inadequate scientific evidence.

    Journalists & bloggers – no excuse for making these mistakes (again).

    If you have questions about the FDA action, please read the key NEJM study first. Then read the FDA’s 69 page review of the scientific evidence. We’re interested in data here at TIE, so comments are welcome about the validity of the evidence base on this question.

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  • Global health reform, PhRMA-edition

    The proposals in the now-leaked Trans Pacific Partnership (TPP) trade agreement text go far beyond patents and exclusivity for drug data (delaying generics), but also make domestic drug reimbursement a matter of international law.  The TPP would curtail the freedom of governmental health plans to negotiate or set pharmaceutical prices.

    The US can’t come to a policy consensus in this area domestically, so setting global policy norms would seem to be a non-starter. Who would try use global trade deals to bypass national legislative processes in a contentious domestic area like health care reimbursement for drugs?

    Start with President Obama, or at least his Office of the United States Trade Representative (USTR).  From the Bangkok Post:

    Mr Obama is now rolling back the Bush-era stance on medical patents. Mr Bush basically acceded to demands from developing countries, led by Thailand, for access to affordable medicines. It was Mr Bush who backed down when challenged by the Ministry of Public Health over drugs for Aids and heart disease. He accepted that the right to affordable medicine trumped strict patent enforcement. The new policy under Mr Obama specifically returns the right of “big pharma” to retain and expand its patent rights. That means a monopoly on any “new” drug and on all marketing. US negotiators at the past two TPP sessions threw these proposals on the table nonchalantly, as if they meant nothing. Civil society groups leapt on the issue, putting the entire TPP proposal at risk.

    For details, see the 52 page report by academics at American, Yale and Northeastern, and the issue brief from Médecins Sans Frontières. For the record, I’m not opposed to making policy in this area, but this is being done in great secrecy, without any normal deliberative political process. We need transparency, not 18th century diplomatic models.

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  • Who’s stealing what, student edition

    Some professors* use Turnitin.com to run plagiarism checks on their students.  Top “sources” for unoriginal college work?

    1. Wikipedia
    2. Answers.Yahoo
    3. SlideShare
    4. Answers.com
    5. OPPapers
    6. CourseHero
    7. Scribd
    8. JustAnswer
    9. eNotes
    10. Amazon

    More precisely, these are the top sources for students caught by Turnitin. Some data from their website:

    * I haven’t used it since I ran a check on one of my own articles and it rated 17% of my material as possibly plagiarized, mainly borrowed from this law professor named Outterson.

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  • Briefing for the Supreme Court cases

    The Court granted cert on several questions from the 11th Circuit cases. It appears we get 90 minutes on severability; one hour on the Commerce Clause; one hour on the Anti-Injunction Act; and one hour on the Spending Power/Medicaid expansion.

    Worst-case scenarios:

    1. For the insurance industry: no jurisdiction to hear the individual mandate under the AIA (3 more years of uncertainty); or worse still, only the individual mandate is severed, leaving the insurance market reforms in place
    2. For progressive health policy: strike down the Medicaid expansion under the spending power (unlike the individual mandate, you can’t fix this one without Congress)
    3. For conservatives: no AIA jurisdictional bar; uphold both commerce and spending
    4. For the Obama Administration: combine 1 & 2 – 5 conservative justices seize the moment to apply Dole to strike down Medicaid expansion, gutting a key part of the ACA, while perhaps a bipartisan group refuses to rule on the commerce clause due to the AIA, leaving plenty to fight about in the next election (h/t to my colleague Abigail Moncrieff)

    The actual language of the cert grants (and length of time for the oral arguments):

    First consolidated cases (90 minutes):

    NFIB v. Sebelius, 11-393. Granted:

    The question presented is whether the ACA must be invalidated in its entirety because it is nonseverable from the individual mandate that exceeds Congress’ limited and enumerated powers under the Constitution.

    Florida v. HHS, 11-400. Granted on Q3 only (but see below for Q1):

    3. Does the Affordable Care Act‘s mandate that virtually every individual obtain health insurance exceed Congress‘s enumerated powers and, if so, to what extent (if any) can the mandate be severed from the remainder of the Act?

    (It’s not entirely clear if these consolidated cases are granted solely on severability or also on Commerce Clause; I lean towards the former, since Commerce Clause is explicitly granted below)

    Second case (2 hours).  Dep’t of H&HS v. Florida, 11-398. Q1 granted:

    1. Whether Congress had the power under Article I of the Constitution to enact the minimum coverage provision.


    Whether the suit brought by respondents to challenge the minimum coverage provision of the Patient Protection and Affordable Care Act is barred by the Anti-Injunction Act, 26 U.S.C. sec. 7421(a).

    Third case (one hour).  Florida v. HHS, 11-400. Granted on Q3 only:

    1. Does Congress exceed its enumerated powers and violate basic principles of federalism when it coerces States into accepting onerous conditions that it could not impose directly by threatening to withhold all federal funding under the single largest grant-in-aid program, or does the limitation on Congress‘s spending power that this Court recognized in South Dakota v. Dole, 483 U.S. 203 (1987), no longer apply?

    My very rough guess on a briefing schedule, assuming orals March 26-27, 2012:  UPDATE – see ACA Litigation Blog for an earlier briefing schedule

    • Petitioner’s briefs due as early as January 23, 2012.
    • Petitioner’s amici briefs due around Feb 1
    • Respondent’s briefs due around Feb. 21
    • Respondents’ amici briefs due around March 1.

    It appears that the federal government is the petitioner on Commerce Clause (depending how you read the grant in 11-393/11-400) and AIA and the respondent on the remaining questions.UPDATE – or, as Brad puts it, both sides are both.

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  • Supreme Court watch

    Everyone expects the order granting cert to be issued today at 10 am ET, but I’ll be in class teaching Health Law, so I suggest the live coverage over at SCOTUSBlog, where live blogging starts at 9.50am.

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  • Religion & the individual mandate

    In Seven-Sky v. Holder, the plaintiff complained that they had religious objections to the individual mandate. The DC Circuit Court of Appeals rejected that argument as well:

    The harms appellants allege–the cost of purchasing health insurance from private companies, and violation of their religious belief that insurance expresses skepticism in God’s ability to provide–exist as a result of the mandate, not the penalty. (Silberman, at 15)

    You might read this entire opinion and miss the very brief mention of the significant religious exceptions in the individual mandate – a religious conscience exception and exemptions for health care sharing ministries. As Sam Grover (BU Law ’12) explains in a recent AJLM paper (ungated at SSRN). The religious conscience exception:

    applies to anyone who is “a member of a recognized religious sect or division thereof described in § 1402(g)(1),” [limited to] (1) sects that “make provision[s] for their dependent members which [are] reasonable in view of their general level of living,” and (2) sects that have “been in existence at all times since December 31, 1950.”

    Think of Catholic religious orders with a vow of poverty. What are health care sharing ministries? Glad you asked:

    these ministries are groups of like-minded, religious individuals who agree to help pay for each others’ medical expenses, thus avoiding the religious objection that some have to mandatory health insurance.

    Think of voluntary groups of evangelical Christians who donate to cover each other’s medical bills, with no legal compulsion.

    Grover critically examines these religious exemptions in some detail (28 pages), so you know where to go if you want more.

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