Recently in Legislation Category
Implementation of the Sustainable Growth Rate, or SGR, formula—the formula ostensibly used to control Medicare spending and physician reimbursement for Medicare services—has been stayed numerous times since it was legislated in the late 1990s. As Harvard policy analysts describe in a newly published study at the NEJM website, the law dictates that the Medicare spending target be periodically set on the basis of several national measures (eg, per capita GNP, Medicare growth), and that, if actual Medicare expenditures on physicians' services exceed the target, an SGR-defined cut kicks in to rein in these expenditures.Almost every year since 2002, the Harvard analysts affirm, the actual expenditures have surpassed the target, and the SGR formula has dictated cuts to close this spending gap or "hole." But Congress—for economic and political (Congress? political?) reasons—has repeatedly sustained these cuts, which are cumulative with each passing stay. The most recent SGR-defined cut in physician fees, now an untenable, practice-killing 27.4%, was temporarily stayed by Congress in December. However, the cut will, at least theoretically, occur at the end of this temporary stay, the end of February—unless Congress votes on yet-another stay. Abolishing the SGR formula altogether has been terribly problematic, because canning the law adds tremendously to the already tremendous US deficit, and pundits either differ or are entirely at sea about a replacement bill that would mitigate the costs of trashing the formula.
In the Harvard study, sources of the spending gap or hole, from 2002 to 2009, were examined by state and specialty, and considerable differences were found by either parameter. For instance, the specialty of cardiology—perhaps justifiably, perhaps not—contributed substantially to total expenditures and excess growth during the examined time period. Between 2003 and 2009, the specialty overshot its SGR target by nearly 80%. On the other hand, general surgery undershot its estimated SGR target by more than 100%. The point: it would be unfair to penalize general surgeons with an across-the-board SGR cut if they didn't contribute to excessive Medicare spending.
The authors' conclusion, however, is not to readjust the SGR-defined cut by specialty or state, but to go more granular to control physicians' Medicare reimbursement. In an accompanying audio commentary, anchor author Michael Chernew calls Congress's short-term fixes "shameful" and argues that the least-reprehensible solution is to have Medicare reimbursements based on the expenditures of smaller physicians' organizations (something like accountable care organizations), which would accept "global payments or payments bundled by episode of care." These smaller organizations would allow physicians to control fees, he argues, and to take greater responsibility for their expenditures by "eliminating lower-value therapies and delivering higher-value health care." On the basis of observed experience in Massachusetts, Chernew estimates that MDs could be pushed into these organizations "very rapidly," say within the next 3-4 years, depending on how the SGR formula is "fixed" by Congress.
Image of the Grand Canyon from the Association of Environmental and Engineering Geologists.
Sherley et al v Sebelius et al. The case that won't go away...to the chagrin of scientists who rely on government funding for research with human embryonic stem cells (hESCs).The Nature News Blog reports today that scientists James Sherley and Theresa Deisher, who choose to work with adult stem cells, are appealing Judge Royce Lamberth's reluctant decision in July to shoot down a permanent injunction against federal funding for hESC research. The scientists submitted their legal brief yesterday to the US Court of Appeals for the DC Circuit. The appeals court, which ruled against Sherley et al last April (with respect to their request for a preliminary injunction), will hear oral arguments on April 23rd in this new appeal to overturn Lamberth's ruling against a permanent injunction.
But a similar decision granting federal funds for hESC research by the appeals court is not a given. The randomly selected, 3-judge panel for the April hearing will be somewhat different than the one that ruled last year, the Nature News Blog reveals. The judges for the upcoming appeals hearing will be Republican appointees Chief Judge David Sentelle, Judge Janice Rogers Brown, and Judge Karen LeCraft Henderson. The lone, common panel member is Henderson, who dissented in the previous appeals hearing by calling the government's favorable interpretation of existing law (ie, the highly ambiguous Dickey-Wicker amendment) "linguistic jujitsu."
Image of undifferentiated hESCs from http://www.nih.gov/catalyst/2007/07.01.01/page1.html.
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.
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).
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.
Judge Royce Lamberth, the chief judge of the US District Court for DC and the guy who originally granted a preliminary injunction against stem-cell research in the case of Sherley et al v Sibelius et al (and created a lot of havoc within the NIH and among US stem-cell researchers), has now decided that it's all okay—begrudgingly. On Wednesday, Lamberth issued his ruling on a permanent injunction that makes federal funding of research with human embryonic stem cells (hESCs) legal (go here for the Nature News Blog's story). Lamberth's decision on a permanent injunction was evidently informed by the opinions of the US Court of Appeals for the DC Circuit, which shot down Lamberth's original, preliminary injunction last April. At the heart of Lamberth's newly revised opinion is the remaining ambiguity of "research." He concludes,
...the DC Circuit has made it abundantly clear that the term is ambiguous as a matter of law. While it may be true that by following the Court of Appeals' conclusion as to the ambiguity of "research," this Court has become a grudging partner in a bout of "linguistic jujitsu," [quoting a phrase from the Appeals Court's dissenting opinion], such is life for an antepenultimate court.And so, for the losing plaintiffs, their option is to accept Lamberth's reluctant decision or to pursue their case to the ultimate court.*
* US District Court for DC = antepenultimate court; US Court of Appeals for the DC Circuit = penultimate court; Supreme Court = ultimate court.
Twelve days ago (April 29, 2011), the US Court of Appeals for the DC Circuit finally ruled (in a 2-1 decision) against a preliminary injunction that banned the use of federal funds to support research on human embryonic stem cells (hESCs).* (So, to sift through the multiple negatives in that sentence, there is now no preliminary injunction against the use of hESCs in medical research. In other words, the government can fund hESC work...at least for now.)The preliminary injunction was granted by Judge Royce Lamberth way back on August 23 of last year in the case of Sherley et al v. Silbelius et al (for essential background on this issue, see last year's no. 3 story at Pathophilia). Given the strike down, it is presently up to Lamberth to rule on a permanent injunction against federally funded hESC research.
And so now, given the appeals court 2-1 split decision, the original plaintiffs (Sherley et al) want to amend their complaint, reports The Great Beyond blog. Their proposed additional arguments are presumably informed by the opinion of the dissenting appeals court judge, Karen LeCraft Henderson, who called her colleagues' reasoning "linguistic jujitsu." The defendants (ie, the government), in no surprise, oppose the plaintiffs' "unnecessary" motion to amend their complaint.
When Judge Lamberth will make his ruling on a permanent injunction in this case is a big, useless guess—like, oh, sometime in the future.
* The appellate arguments were made in December of last year.
Image of undifferentiated hESCs from http://www.nih.gov/catalyst/2007/07.01.01/page1.html.
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.
The shockingly haggard appearance and increasingly pressured rants of unemployed actor Charlie Sheen in the latest episode of his homemade web show, "Sheen's Korner," beg the question, now more than ever:
What is the process for involuntarily commitment in the state of California?
Fortunately (or unfortunately), we've been down this road before—specifically with Ms. Britney Spears, who was very publicly involuntarily committed twice for psychiatric evaluation in 2008. And the behaviors that led to Spears's commitment—public head shaving, attacking a car with an umbrella, sobbing in public—don't seem any more disturbing than those of Mr. Sheen during the last 2 weeks. On the contrary, I would argue that Sheen's recent behavior has been more troubling than that of Spears, given his allusions to extreme violence in his verbal tirades (eg, slitting throats) and yesterday's bizarre wielding of a machete on the roof of the Live Nation office building in Beverly Hills.
In California, the process of involuntary commitment is performed under the state statute known as 5150, in which a designated clinician (prompted by family members), a public safety officer, or an EMT may initiate the process for a 72-hour hold. But the criteria for probable cause are relatively strict in California and dictate that a person must pose a danger to himself or others or is "gravely disabled."
The latter term, according to the 5150 application, "means a condition in which a person, as a result of a mental disorder, is unable to provide for his or her basic personal needs for food, clothing and shelter." It is a criterion that might be difficult to establish in Sheen's case, unless it can be reasonably documented through photographs and film (and I think that it could be) that he has lost a considerable amount of weight in a brief period of time.
Nevertheless, according to Keith Valone, a clinical psychologist* who was quoted by the LA Times in 2008, "Getting a 5051 isn't a very hard [process] to do. Families can either call a hospital, ask if they write holds and then just present at the hospital. Or if the patient is uncooperative, they can call the police."
Here's hoping that someone acts shortly.
* Who wasn't involved in Spears's care.
Screen capture of episode 3 of "Sheen's Korner."
03/09/11 addendum: There are veiled and certainly not-so-veiled indications that Sheen might pose a danger to others. In addition to a current restraining order, granted on the basis of alleged physical threats toward his estranged wife, it has been reported that one of Sheen's live-in girlfriends abruptly left his home late last week. Sheen's own words (through Tweeting and the first episode of "Sheen's Korner") suggest that the woman escaped after being exposed to Sheen's misdirected anger.
There also may be indications that Sheen is a danger to himself. According to Life & Style magazine, for what this source is worth, Sheen's friends now fear that he is suicidal.
Two notable court rulings:
One by the Supremes, who ruled in a 6-2 decision* yesterday that the National Childhood Vaccine Injury Act of 1986 "preempts all design defect claims against vaccine manufacturers brought by plaintiffs who seek compensation for injury or death caused by vaccine side effects." The crux of the decision was the statutory text,
No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and accompanied by proper directions and warnings,
with much parsing of the words "unavoidable" and "even though" by Justice Scalia, who wrote the majority opinion. Justice Sotomayor, along with Justice Ginsberg, "respectfully" dissented, concentrating on the same phrasing.
It should be noted that the case of the allegedly injured plaintiff, Hannah Bruesewitz, had been considered by a Special Master of the US Court of Federal Claims (aka the "Vaccine Court") in 1995. However, the Special Master denied the Bruesewitz's claims "on various grounds"; nevertheless, they were awarded $126,800 in attorney's fees and costs. The plaintiffs rejected this decision and sought recompense in a Pennsylvania state court—an action that was intended to be prevented by National Childhood Vaccine Injury Act. The crux of the plaintiffs' argument was that the vaccine design was defective.
The other decision is by Judge Glady Kessler of the US District Court for the District of Columbia, who has ruled that the Patient Protection and Affordable Care Act is constitutional. Kessler evidently poo-poohed the idea that a decision to not buy health insurance is inactivity—citing such an argument as "pure semantics." She wrote, "Making a choice is an affirmative action, whether one decides to do something or not do something." Her decision is in direct contradistinction to separate rulings made by a Virginia judge (Henry Hudson) and a Florida judge (Roger Vinson), who declared PPACA (or parts of it) unconstitutional. Kessler joins 2 other federal judges, 1 in Virginia and 1 in Michigan, who favor the wording of PPACA. To date, the judges' decisions are predicted by the party of the President who appointed them.
* Kagan "took no part."
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.
