Recently in Health care Category

In a Pharmalot interview, money manager, blogger, and diabetic David Kliff absolutely excoriates "Buttah Queen" Paula Deen and insulin-maker Novo Nordisk for their newly announced, and arguably duplicitous, promotional relationship. Kliff easily tosses out words like "hypocrite," "shyster," and "bastardizing" like so many fat calories in a bacon-and-fried-egg hamburger with doughnut buns.

The intriguing "Do Nothing" option for reducing the country's $15-trillion deficit ostensibly includes a passive stance toward a looming cut to physicians' Medicare reimbursement on January 1. The ever-escalating SGR-defined cut, which has been stayed numerous times by Congress over the years, now exceeds a practice-killing 27%. Primary care physician Don Klitgaard in Iowa, interviewed by the Associated Press, predicts along with the rest of us that "there's going to be a temporary fix, because the health care system is going to implode without it." But an unidentified "senior Washington lobbyist" warns, "It's entirely possible given past performance that Congress misses the deadline." Compromise solutions are reportedly being entertained; they are painful, but not necessarily draconian, for physicians.

SGR = sustainable growth rate.

Image of Westall's Sword of Damocles (1812) from Wikipedia. Meh: not a perfect analogy but close enough.

I have to say that the most astonishing finding from President Obama's most recent routine physical examination is not that he's smoke-free or that his LDL fell with presumptive dietary changes or that he even got a PSA test but that he has 20/20 vision, near and far, without correction. Who the hell doesn't have to wear glasses for something after the age of 50?

Photo of a glassless #44, from http://www.whitehouse.gov/about/presidents/barackobama.

This week's NEJM provides a useful barometer article, including a neato graphic timeline, on the litigation status of [PP]ACA ("Not So Fast—Jusisdictional Barriers to the ACA Litigation"). Thanks, Mssrs Jost and Hall.

Their salient points:

• So far, ~30 lawsuits have been filed against the ACA.
• A Supremes' decision in June 2012 is likely, given the admin's petition for their review on September 28.
• The jurisdictional issues generally, which are somewhat intertwined, rest on one of the following:
• Whether Congress exceeded its constitutional authority when imposing the individual mandate to purchase insurance.
• Whether state or individual plaintiffs have standing when challenging the ACA—particularly, in the latter case, before the "meat" of the ACA (eg, the individual mandate) goes into effect in 2014.
• Whether grievances are sufficiently ripe—meaning whether cases have been filed prematurely (before the "meat" of the ACA goes into effect in 2014).
• Whether the fine for not purchasing insurance is a penalty or tax or something else altogether (eg, an "exaction"*) and whether the label really makes any difference (the answer: it seems to; in fact, maybe big time).

My favorite part of the article, however, is the reference for the table outlining the status of 6 ACA cases.** It is the ACA Litigation Blog (a blog!), evidently run by Santa Clara law professor Brad Joondeph. Har-dee-har-har, NEJM.

ACA = Affordable Care Act.

* Haven't heard that one yet.
** For scorekeepers: 1, it's constitutional; 1, it's unconstitutional; 4, no jurisdiction; 1, decision pending.

There are few press releases crowding my inbox that merit attention, but today's e-mail from the National Union of Healthcare Workers (NUHW), if true, is a stunner.

According to a new report from the union, the average annual combined pay and benefits* for CEOs at California's largest HMOs is $7.4 million. Million. Million.

And this obscene compensation is in the context of, as if anybody didn't already know, historic economic hardship and escalating healthcare costs. The most well-compensated execs were Wellpoint's Angela Braly ($13.1 million) and Kaiser Pemanente's George Halvorson ($7.9 million as of 2009), the CEO of the tax-exempt and ostensibly nonprofit HMO. (They earn every penny.) The president and COO of Kaiser, Bernard Tyson, according to NUHW, receives 8 separate pension and retirement plans.

Contrast these compensation packages, the NUHW says, with the average weekly income of the American worker in late 2010: $752 (or about $39,000 yearly). And after adjusting for inflation, the NUHW argues, workers are actually making less, because in part (hey, get this) a large part of inflation is due to rising healthcare costs. Before adjusting for inflation, the annual raise for the average American worker was a paltry 0.5%, says the NUHW, whereas some Kaiser execs received payment increases just last week of more than 17%.

The NUHW scolds, nay excoriates, Kaiser for "awarding its executives a king's ransom" while "raising member rates and demanding huge economic concessions from their employees who provide the health care." The apparent instigator of this executive-damning report is management's attempt to "eliminate employees' only defined-benefit pension plan."

And although the NUHW report focuses on Kaiser, the overpayment of healthcare execs isn't limited to the company (to noone's real surprise). Samuel Downing, former CEO of the Salinas Valley Memorial Healthcare District, got a cash severance of $947,594 in 2008, $3.9 million in one-time retirement payments this year, and generous ongoing payments from a regular pension plan. His base annual salary, while serving a 226-bed public hospital in Salinas, was $670,000. In an attempt to find revenue for Dowling's payout, the hospital tried to lay off 200 frontline healthcare workers, the NUHW claims. The union says that regular annual pay increases (from ~6% to ~30%) were provided to other Salinas execs between 2005 and 2010.

* Including perks like bonuses, multiple pensions, homes (homes!?), personal drivers, paid travel, access to corporate jets, and so-call gross-ups--in which execs are able to write off associated taxes on benefits.

Photo of Angela Braly from Wellpoint website.

Congressional leaders agree that the SGR formula, the legislated formula used to calculate ongoing cuts in Medicare reimbursement to physicians, has to go. But passing a permanent fix has been stymied, in part, by the nature of the legislative calendar, said Congressman Michael Burgess, MD (R-TX) yesterday to MedPage Today. Congress has consistently had trouble getting its act together to pass a reform bill before the August recess, Burgess implied to the medical news source.

Several medical societies, including the AMA, recently submitted their SGR alternatives to the House Energy and Commerce Committee, which requested the proposals in late March, reported Medscape's Robert Lowes 3 days ago. The committee, which held a public hearing on the topic yesterday, is in charge of spearheading some type of Medicare-reimbursement reform measure.

The current stop-gap measure to suspend the SGR formula, enacted in December, delays the legislated cut until January 1 of next year, at which time Medicare reimbursement will drop by a practice-shocking 30%.

SGR = sustainable growth rate.

Photo of weathered can from magannie at Flickr.

Ugh. More potentially amazing medical science by way of press release, rather than peer review.

Yesterday's Guardian reported that Oxford scientists have "successfully" tested a universal influenza vaccine, which could replace (or more likely, complement) seasonal inoculations. The vaccine, unlike current formulations, is targeted against essential core proteins (namely, nuceloprotein and matrix protein 1) that are common to most influenza A virus strains, rather than the variable surface proteins (designated by the "H" and "N" in virus names). The new vaccine is also intended to produce a protective T-cell response, instead of a traditional antibody response.

The major caveat to this story (in addition to the fact that the study results have not been published in a peer-reviewed journal*) is that the Oxford team has tested the new vaccine on only 11 individuals, who were then subjected to the Wisconsin strain of the H3N2 influenza A virus. The subjects' (flu-like) symptoms—if they occurred—were compared with those of 11 unvaccinated, but virus-exposed, people.

The team reported that the new vaccine was clinically protective and boosted activated T cells; although detailed results are not provided by the newspaper. Other important take-aways from this premature story:

• The Oxford scientists are speculating about combining the new T-cell vaccine with the traditional antibody-boosting strains to promote complementary forms of immunity against influenza A.
• A T-cell response may be an important way of complementing vaccine-induced immunity in the elderly, who tend to produce less robust antibody responses to vaccines.
• A much larger trial of the new vaccine, with "several thousand" people, is anticipated.

* Although the results have reportedly been submitted to an unidentified journal.

Weighing in with lightening speed in the NEJM,* legal scholar Mark Hall calls Judge Vinson's recent ruling on PPACA "far and away the most prominent decision issued to date in this ongoing litigation." The reason for the ruling's prominence, at least in part, is because the suit involved 26 plaintiff states, Hall argues. I would also propose that Vinson's ruling, despite gutting PPACA and leaving healthcare reformists at square one, is notable for its even-handedness and understandability.

Nevertheless, Hall reminds us: Florida et al vs HHS et al "is only one of about two dozen legal challenges across the country." Of the 4 suits in which federal decisions have been rendered so far,** the judgments are split: two in favor of PPACA (in Detroit and Lynchburg, VA); and two against (in Richmond, VA, by Judge Hudson, and in Pensacola, FL, by Vinson). Hall says that the judges' decisions are consistent with the party of the President who appointed them.

The unifying crux of the rulings is whether the judges buy into the notion that commercial inactivity (ie, not buying insurance) actually constitutes activity. What is being uniformly rejected, however, by the 4 judges is the government's argument that the penalty on an individual for not buying insurance is, in effect, a tax—an argument proposed by Yale law professor Jack Belkin as a slam-dunk for the constitutionality of PPACA. It appears Vinson and the other ruling judges are placing heavy weight on the PPACA wording of "penalty" (as opposed to "tax"), to Belkin's likely chagrin.

The next round of appeals in these cases, as they wend their inexorable way to the Supreme Court, will begin in the Fourth and Sixth Circuits (overseeing the Lynchburg and Detroit cases, respectively). An appeal in Florida et al v HHS et al goes to the Eleventh Circuit. Hall predicts that the Supremes won't consider one of these cases until next year, or even 2013—the year before the legislated insurance mandate is to begin. "Meanwhile," Hall writes, "the work of implementing the [PP]ACA proceeds apace.

* At least in terms of medical-publication speed.

** Hall says that, of the remaining suits, the majority have been tossed on the basis of procedural grounds, and the rest are pending.

Brrrr. It's a chilly how-do-you-do for PPACA supporters.

A federal judge said yesterday that all of the Patient Protection and Affordable Care Act should be tossed because of the insurance mandate, which he views as unconstitutional. The decision by US District Judge Roger Vinson is the culmination of a sweeping suit brought by the attorneys general from a parade of mostly red states,* Florida et al v HHS et al, which sought to knock down the Obama Administration's landmark bill. 

Vinson's ruling is distinct from that of Virginia's US District Judge Henry Hudson, who ruled similarly in December that PPACA's insurance mandate is unconstitutional. Hudson, however, attempted to negate the insurance mandate while leaving the rest of PPACA intact; Vinson (probably logically) tosses all of PPACA out the window after gutting its essence, the insurance mandate. "I must conclude that the individual mandate and the remaining provisions are all inextricably bound together in purpose and must stand or fall as a single unit," he wrote. "The entire act must be declared void."

Accordingly Vinson drew on his reading of the Commerce Clause and Congress's powers to penalize (or tax?) individuals for commercial inactivity (ie, not buying health insurance). He concluded, "If Congress can penalize a passive individual for failing to engage in commerce, the enumeration of powers in the Constitution would have been in vain...and we would have a Constitution in name only [emphasis added]."

Vinson is also the guy who brought up the broccoli question ("If [the federal government] decided everybody needs to eat broccoli because broccoli makes us healthy, they could mandate that everybody has to eat broccoli each week?"), which was considered by JDs from Boston University in a year-end issue of the NEJM.

Robert Lowes, writing for Medscape, has more of the story, including speculation on when the Supreme Court might consider one of the many cases challenging PPACA.

* Listed plaintiffs are officials from Florida, South Carolina, Nebraska, Texas, Utah, Louisiana, Alabama, Michigan, Colorado, Pennsylvania, Washington, Idaho, and South Dakota.

In a follow-up to last year's (last year's!) No. 1 story, commentary is made here on another Perspective piece in the NEJM. In last week's issue, JDs from Boston University's School of Public Health ask (in a roundabout way of addressing PPACA's insurance mandate), "Can Congress Make You Buy Broccoli?"

The lawyers, Wendy Mariner, George Annas, and Leonard Glantz, describe (unlike Yale's Jack Balkin), the "continuing uncertainty over the constitutionality" of PPACA on the basis of "conflicting trial court rulings and scholarly commentaries." They cite 4 reasons for why the "constitutional question," as they call it, is so damned thorny.

1. Congress has never required anyone to buy a product from private industry. What isn't in doubt, Mariner et al acknowledge, is Congress's power over the health-insurance industry under the Commerce Clause. What is unclear, however, is whether Congress can demand that uninsured Americans buy health insurance (so that the insurance risk is spread and that costs remain manageable, as a result).

2. The answer to reason no. 1 depends on how the Supreme Court (or other federal courts, for that matter) will interpret the scope of the Commerce Clause. To confuse predictions, the high court has lately provided both conservative and liberal readings of the Clause, which "makes it almost impossible to predict how it will view the requirements of [PPACA]."

3. The thorniest issue, the lawyers propose, is whether inactivity (ie, not buying health insurance) actually "qualifies as an activity that affects interstate commerce." If the Commerce Clause allows Congress to penalize (or tax?!) Americans for inactivity (really activity), the Obama administration will have to demonstrate why this reasoning doesn't allow Congress wider authority (via the Commerce Clause). For instance, the Justice Department will have to show why Congress couldn't penalize Americans for not buying a car to sustain a failing automotive industry. Now the argumentative distinction may lie in the necessity of the purchase, the authors counter. The DoJ might rebut to the Supremes: People require health coverage but not necessarily a car.

4. But this pro-mandate rebuttal might be difficult. There are other necessary or simply good-for-you commodities—like water, food, broccoli—but Congress doesn't legislate their purchase or the purchase of insurance to pay for them (when Americans can't afford them). 

Mariner et al provide no pat answers (unlike Jack Balkin), but their closing thought is an intriguing one: The Constitutionality of the insurance mandate is an issue that is distinctive to PPACA. It would not be raised (and is not raised) in the cases of Medicare, Medicaid, and Veterans Affairs medical services, because these are government healthcare programs supported by Congressionally imposed taxes. If PPACA had provided a national healthcare program (eg, had expanded Medicare to everyone) instead of accommodating a private healthcare insurance industry, there would be no Constitutional argument.