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10 posts from September 2007

September 24, 2007

Organ procurement in a world gone wild

Organs for transplantation are so scarce, and the imperatives for organ procurement are so compelling, that some folks seem to do the darnedest things (even if we leave recent and not-so-recent stories about China out of this discussion).

Consider the recent story of a transplant surgeon who allegedly put the interests of potential recipients above those of a potential donor and got socked with criminal charges in California as a result -- a striking story and the impetus for my writing about organ transplantation today.

There are clearly points of tension between donor and donee, e.g., choosing a "good death" unattended by tubes and machines vs. going all-out to preserve organs for transplant. Patient self-determination butts heads with the so-called Breakthrough Collaborative, which has, for the past several years, sought to increase the "conversion rate" (i.e., rate of organ donation by eligible donors).

New federal regulations governing transplant centers don't really address procurement efforts, and state laws are being revised to allow for more organ donations, by potentially impinging on donors' wishes for a good death in order to preserve donated organs.

The demand for organs has always outpaced supply in this country (OPTN figues show a US organ transplant waiting list of about 98,000 at the moment), and these recent developments are just some of the ways folks are trying to deal with this. For further background, there is an interesting Joint Commission white paper on organ donation, a few years old but worth a read.

Another sort of approach, which I would personally like to see explored more fully in this country, would be adoption of a "soft" presumed consent law -- a reversal of the current legal presumption regarding consent to organ donation, but with appropriate protections allowing individuals and family members to opt out. For background on this approach, see the British Medical Asscociation's recommendation regarding presumed consent.

It seems to me that we've been waiting for science fiction solutions -- like artificial hearts (though Jarvik is now hawking Lipitor) and xenografts -- to become mainstream, instead of dealing with this issue head-on.

-- David Harlow

Blawg Review voir dire at Deliberations

Kudos to Ann Reed -- a trial lawyer and jury consultant -- for hosting a well-put-together Blawg Review at DeliberationsThose of us who practice preventive law hope you never need the services of Ann and her colleagues, but it's nice to know they're there . . . just in case.

-- David Harlow

September 20, 2007

Minute Clinics in the news again

A tip of the hat to Ben Kruskal at Dr. Ben's Blog for pointing to Mass Medical Society president-elect Bruce Auerbach's Boston Globe op-ed piece on Minute Clinics and DPH's response (and to earlier posts of Paul Levy's, at Running a Hospital, and of mine, here at HealthBlawg, on the subject).

Bruce lays out a healthy skepticism about the retail clinic model; while I know him personally and would not presume that this is his motivation, the very fact of his writing will prompt some readers to dismiss his thinking as that of a turf-protecting doc.  He lays out some of the arguments against permitting the proliferation of retail clinics, or, to put it another way, in favor of regulating retail clinics' operations, as one specialty society has proposed.

The challenge to parties on all sides of this debate is to stay on-topic and focus on the issues at hand rather than real or presumed interests of the parties.

Check out the DPH press release with links to the proposed "limited service" clinic regs.  Comments will be accepted through September 28.

-- David Harlow

Health Wonk Review - the back to school edition

Joe Paduda hosts the current HWR roundup at Managed Care Matters, leading off with a look at HillaryCare 2.0. 

Sidebar:  For those of you in the Boston area interested in getting up close and personal with Mrs. C on October 10, consider attending the New England Lawyers for Hillary event (human beings also welcome).

-- David Harlow

David Harlow to speak at annual two-day MCLE extravaganza on health law coming up next week

The annual two-day-long Health Law Basics Plus program at Massachusetts Continuing Legal Education is coming up next Wednesday and Thursday (9/26-9/27). 

For those of you who are Massachusetts lawyers with an interest in learning more about the wild and wonderful world of health care: check out the program and come join us for a total-immersion introduction to health care regulatory and business law.  The panel includes a bunch of terrific practitioners and speakers.  Hope to see you there.

-- David Harlow

September 19, 2007

From Shakespeare to DOJ -- Let's kill all the lawyers

. . . or at least let's try to convict some health care lawyers.

Two hospital lawyers famously escaped conviction in the U.S. v. Anderson case (D.Kan. 1998).  And we all thought we were safe from prosecution under fraud and abuse, Stark and false claims laws.

This week, the DOJ has filed a complaint against Tenet's former general counsel for certifying claims a while back that were later the subject of a $22.5 million settlement paid by Tenet.

It will be interesting to see how DOJ seeks to distinguish this case from the earlier one.

-- David Harlow

September 18, 2007

David Harlow to speak on Massachusetts universal health care law at Business Lawyers Network

I will be speaking at this Thursday morning's meeting of the Business Lawyers Network here in the Boston area, focusing on what employers need to know about the Massachusetts universal health care law (link to PowerPoint presentation).

Learn more and register at the BLN website, a/k/a lexpertise

I couldn't have asked for more timely point-counterpoint on the subject of the law's implementation: check out Steffie Woolhandler and David Himmelstein's "trashing" of the universal health care law in yesterday's Globe, and John McDonough, Brian Rosman and Lindsay Tucker's comeback on A Healthy Blog.

-- David Harlow

September 17, 2007

The latest on never events and HAI from CMS, Leapfrog and MA DPH

Everyone's talking about never events, ever since CMS announced its no pay policy for never events last month. But, hey, the CMS reg just implemented a DRA provision that's a couple years old. Not only that, the commercial P4P gang -- e.g., the Leapfrog Group -- already has never events policies in place that go beyond the CMS reg (including apologies and real no-pay rules).

Update 9/25/07:  In an email exchange, the Leapfrog Group's Rachel Weissburg elaborates:  "Leapfrog supports CMS's policy but would like to see it expand to address all 28 Serious Reportable Events. . . .  Leapfrog's Never Events policy . . . also asks hospitals to apologize, report the event, and perform a root cause analysis - critical steps in preventing the event from ever occurring again and also healing the breach of trust between physican/hospital and patient."

Per Managed Care magazine,

The proposed CMS rule change is more limited in scope. If adopted, it will take effect on Oct. 1, 2008, and "will mean that hospitals will not benefit from higher reimbursement for [specific] conditions that were not present at the patient's admission," says CMS spokeswoman Ellen Griffith-Cohen. "We cannot speculate how the private sector will respond."

So why the brouhaha now?  Well, chalk it up to the 800-pound gorilla nature of CMS.  And some hospital folk just get wrapped around the axle of rules like this.  Consider one of the issues on the table in today's Boston Globe article on never events and the no-pay rule: does the rule mean a hospital can't bill for additional surgeries required because of an HAI? Probably.  Does it mean that it has to pay a crosstown rival's bills if a patient with an HAI wants to go elsewhere for followup treatment?  Hmm.

Yes, there are issues to be ironed out, but the core concept is a sound one. 

What I find fascinating here is that in an arena where the regulated community is basically saying that "never" is a mighty tough standard, there has been no discussion of a "substantial compliance" standard, a la OBRA '87.  (If there has been and I've missed it, please clue me in.)

Anyone out there know what I'm talking about?  HCFA -- predecessor to CMS -- and the regulated community took ten years and a bajillion pages of comments to hash out a regulatory scheme designed to implement a zero tolerance statutory scheme governing nursing facility survey and certification. (Echoes of never events.)  In the real world, the statutory standard of absolute "compliance" with Medicare conditions of participation morphed into "substantial compliance."  Maybe, at first blush, that seems incompatible with the concept of never events.  However, it seems to me that some real-world testing of the never event concept needs to happen, including an approach that recognizes that not all never events can be tied to medical errors, just as the lawyer-bashers out there (come, come, you know who you are) would have it that not all bad outcomes can be tied to negligence or malpractice.

While the core concept may be sound, another argument against no-pay for never events is that the dollars at stake are not significant enough to get hospitals' attention.  Lest that be construed as an invitation to add more never events to the list and add penalties to withholding of payment, let me simply suggest that CMS and other payors could get more bang for the buck in other quality initiatives.

HAI is just one of the many never events flagged by both Leapfrog and CMS.  Massachusetts' Department of Public Health has been wrestling with the issue as well, as illustrated by a recent report on HAI in Massachusetts.  Last week, DPH revealed (in a presentation by Paul Dreyer to the Public Health Council) that it would like to expand its hospital surveyor staff and add review of infection control policies, practices and outcomes -- and sharing of best practices across institutions -- to the work of the survey teams.  Like the Leapfrog initiative, this approach is focused on rooting out the bad and nurturing the good.  And it seems that it can be more positive than punitive.

-- David Harlow

September 06, 2007

P4P spreading like wildfire

Two reports on P4P were issued in recent weeks.  Follow the links to the P4P report form PriceWaterhouseCoopers and to the executive summary of the P4P report from MedVantage and the Leapfrog Group.

The MedVantage/Leapfrog report projected "there will be 155 pay-for-performance programs in place this year, compared with only 39 in 2003," per a Modern Healthcare article this week.

That article continues:

The [PWC] report looked at 10 different pay-for-performance programs and found that, together, they used almost 60 different physician-performance indicators, no one indicator was used by all 10 programs, and no two programs rewarded providers the same way.

Pay-for-performance programs can be an important tool to link payment to quality, the PWC report stated, "But the wide variation in program structures, performance metrics and rewards structures mutes their potential impact."

"I thought the report by PWC was pretty much on the money," said Francois de Brantes, national coordinator for the Bridges to Excellence physician-reward program. "Most of the employers and the plans we work with are increasingly cognizant of the fact that this dispersion of attention just creates a lot of noise, and that we need to strengthen the signal by having very clear standardized measures used by multiple plans and employers in a single community."

Bridges to Excellence is, of course, doing just that.  Another player in that space is Premier, which will be kicking off its QUEST P4P initiative in the near future.

If physicians can know that their performance will be measured by multiple payors against the same yardstick, they can be much more focused and efficient in their addressing of specific performance measures.  Better yet, if payors put some serious money on the table, they would tend to get physicians' full attention (e.g., put more than 10% of compensation at risk, vs. 5% or less).

CMS will get in on the action next year, as its value-based purchasing transitions from pay-for-reporting to P4P.

There seem to be trends towards standardization of measures, though as the PWC report notes, we're pretty far from optimal on that front.

The Modern Healthcare article jokes that the biggest winners here are the EHR companies pushing their products as the necessary means to tracking and reporting performance.

I also see organizations like Bridges to Excellence and Premier jockeying for position as keepers of the flame, bringing larger and larger numbers of providers into their respective big tents.

I still wonder whether, when all is said and done, the long-term systemic benefits are worth the exercise.  I do not doubt the benefit to the individual provider or group that meets or exceeds its performance targets and is compensated for its efforts.  I also do not doubt that "the train has left the station" (believe it or not, I'm typing those words on a train that is just leaving a station; ah, the human mind) and that P4P is here to stay, at least for a while, whether or not it is 100% analytically sound.  To take a stab at answering my own rhetorical musings, I think that when there is critical mass collected around some consensus measures (NQF or other), sufficient dollars are put at stake, and the federales jump in with both feet, we'll start to see some systemic effects.

-- David Harlow

September 03, 2007

David Harlow quoted in Physician Compensation Report article on Stark regulations; final Stark Phase III rules to be published this week

Elyas Bakhtiari interviewed me for his September article on the proposed Stark regulation revisions tucked into the physician fee schedule regulation.  Check out a PDF of the September issue of Physician Compensation Report right here.  It's published by Health Leaders Media, and the Stark article is the lead story.

Among other things, I said:

This is the sort of thing that makes physicians throw up their hands. It is yet another factor that would lead many physicians to lean more toward work as an employee rather than as an entrepreneur.

Of course, once this issue went to "press," CMS went ahead and released the final Stark II, Phase III regulations a few months before its self-imposed deadline.  Check out the CMS press release, the full text of the regs, and the redlined version of the Stark Phase III regs.  They are to be published this week (September 5) in the Federal Register, and will be effective 90 days after publication.

As with the publication of the interim final regs a few years back, we can look forward to some restructuring of noncompliant deals, though not all arrangements currently in effect will need to be overhauled immediately.

Check back here at HealthBlawg for more on Stark Phase III as I dig out from vacation.

-- David Harlow