Recently in Legislation Category

Law professor Mark Hall (Wake Forest) makes predictions in the latest NEJM about the Supreme Court's decision on the recently argued Affordable Care Act (ACA)—specifically with respect to the constitutionality of the individual insurance mandate. (Although frankly, anyone who's been watching this story could make the same predictions.)

• The 4 Democratic appointees (Ginsberg, Breyer, Sotomayor, Kagan) will vote to uphold the ACA (and thereby the individual mandate).
• Consequently only 1 Republican appointee is needed to side with the Democratic appointees to uphold the ACA. However, there is "no clear support" from the 5 Republican appointees (Roberts, Scalia, Kennedy, Thomas, Alito). Nevertheless, Kennedy is historically a critical swing vote in close decisions, and his statements during the recent argument indicate that he is able to consider both sides of the issues.
  
• It is "very unclear" if the Supremes will toss the ACA, if the individual mandate is declared unconstitutional.
• While some justices appear to be against the Medicaid expansion (which was originally thought to be a non-starter), it is unlikely that there will be enough votes to 86 the provision.

A decision is expected by the end of June.

Today: Premature or ripe?
Tomorrow: Insurance mandate constitutional or unconstitutional?

This week's NEJM offers a very nice we-are-here review of the status of PPACA (aka ObamaCare) and the Supremes' anticipated review of the appellate case, Florida v HHS (which challenges the constitutionality of the law), on March 26th-28th. The 4 questions that the ultimate court will address in the ultimate appeal of this case, according to authors Curfman et al, are the following:

1. Whether contesting the law is premature. In other words, can the legality of a tax (or penalty or whatever) for not buying health insurance be challenged before the tax is levied (in the case of PPACA, in 2014)?
2. If the Supremes decide that a legal review is not premature (ripe?), does Congress have the authority to mandate the purchase of health insurance or levy a tax (or penalty or whatever) for not doing so? Evidently much of this decision rests on the interpretation of the Commerce Clause. A related concern is whether Congress can tax (penalize, whatever) US citizens for not buying a product from a private entity (eg, health insurance or, by extension according to one lower-court judge, a car or broccoli).
3. If the mandate is unconstitutional, the Supremes must then decide if the mandate can be excised from the law or if the entirety of PPACA must be tossed.
4. Last the Supremes must determine if PPACA's expansion of Medicaid exceeds the authority of the federal government to regulate states' voluntary operation of Medicaid programs. Curfman et al note that lower courts have considered this argument a non-starter, but the high court said it would consider it anyway.

Also the NEJM provides yet-another neato, interactive graphic of the case decisions to date.

• 7 at the district court level (1 dismissed, 3 in which PPACA was upheld, 3 in which PPACA was unconstitutional).
• 6 at the appellate court level (4 dismissed, 2 in which PPACA was upheld, 1 in which in which PPACA was unconstitutional)

The one appellate case in which PPACA was determined to be unconstitutional, Florida v HHS, is the case that will be considered by the Supremes later this month.

PPACA = Patient Protection and Affordable Care Act.

Both MedPage Today and Medscape report that some kind of legislative "deal" is near completion for an intermediate-term fix of the pesky sustainable growth rate (SGR) formula—the done-broke formula used to determine physician reimbursement for Medicare-funded services.

Medscape, really by way of Reuters, reports that the deal will be a 10- or 24-month fix, depending on whether Congressional Democrats or Republicans, respectively, prevail in the ongoing negotiations. Senator Jon Kyl (R-AZ) is quoted by the wire service, saying that remaining disagreements could be resolved within the next 2 or 3 days.

Kyl also says that Congress "is unlikely to repeal the contentious reimbursement mechanism because a long-term solution would cost more than $300 billion." The current temporary fix is due to expire at the end of February, at which time a 27.4% cut in physician reimbursement for Medicare-funded services would kick in.

It has been proposed that compensation for the latest, anticipated SGR fix could be found (at least partially) in savings from ending the wars in Iraq and Afghanistan.

02/17/12 update: Congress opts for a 10-month delay.

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.

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.

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.