• 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.

    plus:

    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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  • ACO snatching docs from rival

    In this morning’s Boston Globe, Robert Weisman reports that the Beth Israel Deaconess Harvard Hospital lost 150 physicians in a defection to an upstart venture capital funded rival, Steward Health Care:

    But a law firm hired by Beth Israel suggested that some incentives Steward offered Whittier violate federal and state “anti-kickback’’ statutes. Those laws prohibit paying for business that can be billed to government health insurers. A spokesman for Steward, a fast-growing, for-profit health care company, said its contract with Whittier is legal.

    My money is on Steward on this legal issue:

    • The feds are showing growing fraud & abuse law flexibilities for ACO models, which is where Steward is heading
    • As we’ve said here before, consolidation is one of the effects of the ACO model
    • Notice no mention of Stark II, the more problematic statute in this area
    • Hardly anyone with interesting deals meets all of the anti-kickback statute safe harbors; that means nothing by itself
    • The underlying contract is the BCBS shared savings contract, the current darling of health care reimbursement wonks
    • If Steward wants additional assurance, they can ask for an OIG Opnion
    • Steward’s outside legal team on these issues is excellent (my former firm)

    Prior TIE coverage:  Mass. doctors want to use ACO rules to violate antitrust laws; other ACO TIE posts here.

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  • Seven-Sky v. Holder

    I was teaching yesterday when the DC Circuit Court ruled in Seven-Sky v. Holder, which gave the Obama Administration another victory just in time for the cert conference this Thursday. That’s my excuse for not posting immediately after I’d read it (actually reading the opinion doesn’t slow some people down, but that’s another story).

    But since it’s 24 hours later, I’ve had a chance to read what others posted. The most substantial post that I read was published by BNA’s Health Law Reporter (paywall). When I was in private practice, BNA was required reading every day, and worth every penny.

    I’m going to focus on the Silberman opinion on the Commerce Clause, but Judge Kavanaugh’s 63-page dissent might be the more important text, at least in the short term. If the conservative justices see themselves losing on the Commerce Clause 5-4 or 6-3, they might find 5 votes to deny jurisdiction under the Anti-Injunction Act. That kicks the can down the road until 2014, a terrible result for health policy but one that some might find politically expedient.

    Some highlights from BNA, with my comments:

    Activity/Inactivity:

    Silberman’s opinion acknowledged the uniqueness of the health care market and the novelty of the individual mandate. However, the challengers’ argument that Congress could not compel currently inactive individuals to enter into interstate commerce also was novel, the court wrote.

    “No Supreme Court case has ever held or implied that Congress’s Commerce Clause authority is limited to individuals who are presently engaging in an activity involving, or substantially affecting, interstate commerce,” it said.

    This led the court to examine the text of the Constitution to determine whether it supported the challengers’ contention that there are limits on Congress’s commerce clause power…

    “Regulate,” at the time of the Constitution’s adoption and now, “can mean to require action,” … Nor does “commerce” refer to only “existing commerce,” it said.

    This is the mainstream position on the Commerce Clause. Nice to see that Silberman agrees.

    Economic/Noneconomic:

    Having found no support for the challengers’ argument in the text, the court turned to the Supreme Court’s prior decisions. It determined that the only “recognized limitations” on Congress’s power today are that “(1) Congress may not regulate non-economic behavior based solely on an attenuated link to interstate commerce, and (2) Congress may not regulate interstate economic behavior if its aggregate impact on interstate commerce is negligible.”

    “Those limitations,” the court wrote, “are quite inapposite to the constitutionality of the individual mandate, which certainly is focused on economic behavior—if only decisions whether or not to purchase health care insurance or to seek medical care—that does substantially affect interstate commerce.”

    Silberman reads Morrison and Lopez narrowly; again, this is the mainstream position.

    The broccoli argument

    The court also rejected the challengers’ concern that, if Congress could force individuals to buy insurance, it could force them to do anything.

    This argument “expresses a concern for individual liberty that seems more redolent of Due Process Clause arguments,” the court wrote. “But it has no foundation in the Commerce Clause.”

    The mandate “seems an intrusive exercise of legislative power,” the court said. It added, however, that “that seems to us a political judgment rather than a recognition of constitutional limitations.”

    “It certainly is an encroachment on individual liberty, but it is no more so than a command that restaurants or hotels are obliged to serve all customers regardless of race, that gravely ill individuals cannot use a substance their doctors described as the only effective palliative for excruciating pain, or that a farmer cannot grow enough wheat to support his family,” the court said.

    My colleague, Prof. Abby Moncrieff, has written on these embedded liberty interests in the ACA litigation. Perhaps SCOTUS will cite her work.

    On the politics:

    Influence on Justices?

    The D.C. Circuit’s opinion might have more of an influence on the Supreme Court’s ultimate determination of the constitutional issue, several experts said. Lazarus, for example, said that, given that Silberman shares the conservative viewpoint of several Supreme Court justices, it is “inconceivable” that Chief Justice John G. Roberts Jr. and Justices Antonin Scalia, Samuel A. Alito Jr., and Anthony M. Kennedy “won’t take his opinion seriously.” These justices are likely to be influenced by Silberman’s reasoning, he said.

    Other experts, however, cautioned against predicting an early victory for the reform law. Gerson told BNA “the justices are still the justices.” While Silberman is a “very conservative, very good judge,” the justices “will decide on their own” and will not necessarily be influenced by his opinion.

    Still, Gerson said, the D.C. Circuit’s decision certainly gives the government optimism that the high court could rule in its favor, because the opinion is as important for who said it as it is for what was said.

    Silberman served in the Nixon, Ford, and Reagan administrations and was awarded the Medal of Freedom by President George W. Bush, according to Ian Millhiser, a policy analyst and editor of ThinkProgress Justice in Washington. He also is a personal friend of Scalia and Justice Clarence Thomas, Millhiser said.

    Millhiser said it is significant that this “leading light” of conservatism could find nothing in the text of the constitution to support the challenge to the mandate’s constitutionality.

    Sarah Kliff at WaPo/WonkBlog was quick off the mark with a good political analysis.  Prof. Brad Joondeph at ACA Litigation Blog did his typically excellent work summarizing the key legal points. Unlike BNA, these blogs are free!

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