Disruptive physicians and medical apologies

The Joint Commission (i.e., The Organization Formerly Known As JCAHO) is field-testing standards on disruptive behavior.  The working draft provides some insight into the Commission’s thinking; the elements for performance to this standard are as follows:

1. The leaders develop a code of conduct that applies to everyone who works in the organization.

2. The code of conduct defines desirable and disruptive behavior.

3. All who work in the organization are educated about both desirable and disruptive behaviors.

4. The leaders develop processes for managing disruptive behavior.

5. Leaders identify the roles of individual leadership groups in managing disruptive behavior.

6. The organized medical staff manages disruptive behavior exhibited by physicians or individuals who are granted clinical privileges.

7. Leaders establish a fair hearing process for those who exhibit disruptive behavior.

While noble, the sentiments behind these standards are not brand new.  In fact, a JCAHO standard, circa 2001, touched on these same issues and was addressed, for example, by the Massachusetts Board of Registration in Medicine by promulgation of its own related policy.  Apparently the lighter touch of the earlier standards (which is sometimes extremely important in trying to deal with difficult personalities who are also brilliant clinicians) has proven to be insufficient to deal with the sometimes intransigent issue of disruptive physician behavior.

A tip of the hat to Michael Cassidy at Med Law Blog for noting the proposed standard change.

Unfortunately, disruptive physicians may also be, at times, physicians involved in medical errors.  I heard a terrific piece on NPR a while back on apologies — exploring the question of whether apologies are a good idea, from both psychological and risk-management perspectives.  This is, of course, a hot topic these days (check out The Sorry Works Coalition).

Update 1/25/07:  A Healthy Blog posted yesterday: "Doug Wojcieszak, the founder and spokesperson for the SorryWorks! Coalition, spoke at Health Care for All about apology and disclosure following adverse medical events."  Doug’s slides are up at A Healthy Blog. 

Double hat tip to Michael Cohen at CAM Law Blog (a fellow Bay State blogger) and Daniel Goldberg at The Medical Humanities Blog for highlighting Marlynn Wei’s law review article in press on medical apologies (link to abstract and downloadable PDF).  The article explores whether insulation from legal liability exists under state laws out there, and whether existence of these laws promotes apologies.

Civility certainly ought to be promoted, whether through sanctioning disruptive physicians or through encouraging apologies where mistakes have been made.  Given the increasing availability of provider quality report cards and the like, and the increased ability of consumers to decide where to get their care (thanks to health savings accounts and other consumer-directed health care initiatives), civility is not simply an ethical goal, it should be recognized as a bottom-line business goal as well.

Update 4/13/07: More states are considering medical apology laws.  Check out the AP story here, which includes a discussion of laws already on the books as well.

David Harlow 

HIPAA security guidance for off-site use of electronic protected health information (EPHI)

CMS recently issued a HIPAA Security Guidance document on off-site use and remote access of EPHI, to assist covered entities in their compliance efforts.  As is often the case, the federales are working on closing the barn door long after the horse is out of the barn.  And what good is a policy if it’s not adhered to?  Remember last year’s VA laptop debacle?  The VA had  a policy that should have kept its employee from taking that laptop with unencrypted EPHI on over 26 million folks in the VA system off-site but apparently it was not enforced.

The guidance includes some relatively bold statements regarding the limited range of circumstances under which off-site use or access of EPHI might be appropriate, given the current prevalence of using data off-site (using PDA’s, laptops, smart phones, accessing on-site data via the internet, etc.):

  • A home health nurse collecting and accessing patient data using a PDA or laptop during a home health visit;
  • A physician accessing an e-prescribing application on a PDA, while out of the office, to respond to patient requests for refills;
  • A health plan employee transporting backup enrollee data on a media storage device, to an offsite facility.

However, the guidance immediately follows with a framework for covered entities to use in determining where they will each draw the line:

We recognize that there may be additional business cases that will require the offsite use of, or access to, EPHI. This guidance is not intended to provide a comprehensive list of applicable business cases nor does it attempt to identify all covered entity compliance scenarios. A covered entity must evaluate its own need for offsite use of, or access to, EPHI, and when deciding which security strategies to use, must consider those factors identified in § 164.306(b)(2):

“(i) The size, complexity, and capabilities of the covered entity.
(ii) The covered entity’s technical infrastructure, hardware, and software security capabilities.
(iii) The costs of security measures.
(iv) The probability and criticality of potential risks to [EPHI].”

Specifically, with respect to remote access to or use of EPHI, covered entities should place significant emphasis and attention on their:

  • Risk analysis and risk management strategies;
  • Policies and procedures for safeguarding EPHI;
  • Security awareness and training on the policies & procedures for safeguarding EPHI.

Working on the assumption that developing and implementing ever-more-specific compliance plans, based on ever-more-specific government guidance, will result in improved compliance and thus improved protection for EPHI, the guidance concludes with some useful checklists for covered entities’ policies and procedures, as well as cross-references to additional HIPAA resources back on the CMS website

CMS also admonishes:  Affected covered entities "capable of implementing all of the [recommended] strategies . . . are strongly encouraged to do so."

David Harlow   

To negotiate or not to negotiate – That is the Medicare drug benefit question

One of the Democrats’ "first 100 hours" issues seems to be repeal of the ban on Medicare negotiation of drug prices. 

That’s a good thing.

The N.Y. Times reports today that acting CMS administrator Leslie Norwalk

said that under the Democrats’ proposal her agency would have to “hire hundreds of people to negotiate prices for 4,500 different drugs.” And Ms. Norwalk said the agency would be besieged by lobbyists seeking higher Medicare payments for specific drugs. That, she said, is “how Washington really works.”

I’d call that a copout.   

Remember, her colleagues in the Bush Administration misled Congress when they projected the ten-year cost of the Medicare drug benefit to be $400 billion.  (It will cost $1 trillion; that’s how Washington really works.)  So she can afford to hire a couple hundred employees — not that it should take that many — and still come out ahead.  A one percent savings off the lowball estimate ($4 billion) dwarfs the alarmist supposed cost of administering this program (let’s call it $250 million over ten years if it takes 250 $100,000-a-year employees to do the job).  If we use the current cost estimate, a 1% "shave" for Big Pharma would yield savings of $10 billion.

Yes, Virginia, there are transaction costs inherent in our inefficient health care system, and we have to make sure the savings don’t land in the pockets of the benefit plan administrators, but there’s no excuse for failing to use the market power of the federal government in negotiating drug prices.

Other issues on the agenda include looosening restrictions on federally-funded stem cell research.  The Times article continues:

Lawmakers are also likely to wrestle with these issues:

¶Many Democrats will try to reduce Medicare payments to managed care plans. They contend such plans are overpaid by about 10 percent. Insurers intend to fight back, with support from the Bush administration, Republican lawmakers and beneficiaries who see the plans as a way to obtain extra benefits at an affordable cost.

¶Congress faces a huge challenge in devising a new formula to pay doctors for treating Medicare patients. Under the current formula, doctors’ fees would be cut more than 4 percent a year for the next decade. Lawmakers are determined to avert such cuts, but see no easy way to pay the cost.  [See earlier HealthBlawg posts on this issue here and here.]

¶Democrats have drafted legislation to speed the approval of safe, low-cost versions of expensive biotechnology drugs, which account for a growing share of spending on pharmaceuticals.

Stay tuned.

David Harlow

Health care insurance reform notes from South Carolina

Health care reform watchers here in Massachusetts are following local details as they unfold, interrupted somewhat by the changing of the guard as Patrick appointees will fill various posts now held by Romney appointees. 

Many of us follow with interest developments in other states as well (see this post and comment).  Some in the business community are concerned that the Massachusetts law goes too far in terms of imposing obligations on employers.

How refreshing it is, then, to hear from Jay Ragley, state director of the National Federation of Independent Business/South Carolina, a small-business advocacy group.  He wrote an op-ed piece, on the need for choice in health insurance for small business, that ran in yesterday’s Greenville (S.C.) News.  His piece, and the comments posted on the News website taking issue with it, show that the debate is alive and well not only in MA, NJ, CA, etc., but also in states like SC, described by Ragley as needing health insurance reform and being plagued with extremely poor health status across the population at large.  I don’t know anything else about the insurance market or legislative agenda in SC, but here’s hoping that national engagement with these issues will have positive effects in each state.

David Harlow

Blawg Review #88

Welcome to Blawg Review #88, where you can sit back while some of the masters of the form tickle the ivories.  (Since the number of this edition matches the number of keys on a piano, you’ll have to bear with me through some musical musings; I trust they will not be too painful.)

Ellington_2 To kick it all off I’ll invoke the one and only Duke Ellington, master pianist, composer and bandleader, who once said of performing: "It’s like an act of murder, you play with intent to commit something."

This performance begins with a note on a law regarding an instrument that may be used for acts of murder or acts of self-defense.  David Kopel at The Volokh Conspiracy comments on the Ohio rollback of gun control laws.  In other firearms news, see Concurring Opinions for Dave Hoffman’s musings on the Second Amendment — and hunting permit volume in Pennsylvania.

Chico_1Speaking of guns, Chico Marx always looked like he was shooting the piano keys while he played, but he was probably thinking about gambling, one of his other passions. 

The plaintiff bar seems to be gambling in a calculated way on the Vioxx litigation, according to Ted Frank, writing at Point of Law.  He observes that a recent decision is

the fifth jury victory for Merck in six cases, but, of course, when juries are allowed to award tens of millions of damages, trial lawyers can profitably bring meritless cases if juries get it wrong 15% of the time.

Chico was also an early authority on the reliability of eyewitness accounts, noting: "Well, who you gonna believe, me or your own eyes?" 

It is sometimes hard for anybody to believe the tangled web we lawyers weave, and I think the Marx Brothers would have had a field day with the web of health care regulation, which is my area of specialty. 

This past week, Health Affairs Blog posted a piece on the largest-scale health care issue that will likely face the new Congress: the "Medicare trigger" — a sleeper provision in the Medicare Modernization Act of 2003 which will require massive rearranging of priorities once Medicare budget growth hits certain markers that it will almost certainly hit in the next couple of years.

One contributor to breaking the bank will likely be Congress’ own persistent unwillingness to stick to previously mandated cuts in Medicare physician reimbursement or come up with a better system, as I noted last week here at HealthBlawg.

Michael Cassidy’s Med Law Blog highlights this and other statutory and regulatory developments in a roundup of major Medicare changes for 2007.

Atatum330aArt Tatum, master of improvisation, liked to say that "there is no such thing as a wrong note."  Failing to take its cue from Tatum, Iran’s Foreign Ministry certainly struck one in hosting a Holocaust deniers conference, discussed by Jack Balkin in his post, Dialectic of Enlightenment, on Balkinization.  At Is That Legal?, Eric Muller wrote the Ministry an open letter about his family’s proof of the Holocaust — the death of his great uncle. 

Many people escape discord and persecution — ethnic, religious, economic — around the world by coming to the U.S., often with the hope of having their children born here and thus obtaining U.S. citizenship.  This "birthright" was under attack in the last Congress.  Peter Spiro, at Opinio Juris, tells us that this effort is Another Welcome Casualty of the Midterm Elections.

Coming to the U.S. has been characterized by some as coming in from the cold.  The words of the pop song, Baby, It’s Cold Outside, however, have been turned on their heads by recent weather.  Susan Smith’s Environmental Law Prof Blog says "Baby, It’s Hot Around Here." 

Ray_charles_book_1One of the hottest pianists and singers around, Ray Charles, said: "I never wanted to be famous. I only wanted to be great."  Seeking greatness is admirable; however, as David Maister observes regarding the "size matters" school of corporate management, companies aggressively seeking growth may be less than admirable.  Those seeking greatness through patenting their inventions may have their lives made a bit easier thanks to Google Patent Search (the latest from the Googleplex), says Brett Trout at Blawg IT.  See also Sabrina Pacifici’s beSpacific.  Those seeking greatness by contributing to the store of freely shared software under a GNU general public license (GPL) rather than by developing proprietary works are indebted to Eben Moglen, the key defender

of the GPL.  See Tim Lee’s The Technology Liberation Front for more.

Warren Buffett is probably more famous than he ever wanted to be.  Ted Frank, writing at Overlawyered, is wondering whether Berkshire Hathaway’s acquisition of a med-mal insurer from GE is likely to succeed because (a) GE sold at a fire-sale price, (b) liability caps are coming or (c) Buffett’s the wizard.   

Herbiehancock Herbie Hancock, Buddhist and jazz icon, has mastered several different musical idioms.  As he once said, "Since time is a continuum, the moment is always different, so the music is always different."

Marcy Peek, writing at Concurring Opinions, posits that we should consider the continuum-bending exercise of putting "juniority" ahead of "seniority."

Some might say that our government takes a dangerously relativistic view of the world, particularly in defining terrorism and terrorist organizations; that it may even be, so to speak, tone deaf.  A First Amendment case involving contributions to a charitable organization that ended up on the U.S. government’s list of who’s been naughty may be heard by the Supremes.  See Eugene Volokh’s post on Rahmani v. U.S. (cert. pending) at The Volokh Conspiracy

In the realm of corporate governance, transparency and regulation, there’s been talk about some relaxation of Sarbanes-Oxley requirements recently, as noted at GRC Excellence.  Leon Gettler observes, regarding SOX in the U.S., and other regulatory schemes elsewhere in the world:

When things go wrong, the usual response from politicians is to bring in laws to restore public trust. But it never works. In fact, tough laws only make things worse.

There’s a link to an article of his published Down Under in print at SOX First.

When flying, you might hope to hear the music of the spheres — unless, of course, you’re at the boundary between Vermont and federal jurisdictions and trying to nurse an infant on a commercial passenger jet.  In that case, you may precipitate the Vermont Human Rights Commission being asked to consider whether the federal Airlines Deregulation Act trumps Vermont’s human rights law.  Check out The Mommy Blawg’s Vermont breastfeeding update

Another rupture in the continuum this past week surrounds a trademark battle over an individual’s name, which Ann Bartow was riffing on at Feminist Law Professors.

Monkpic1big"Sometimes it’s to your advantage for people to think you’re crazy."  Those were words for the iconoclastic Thelonious Monk to live by, but not most lawyers.  Some clients seem to think playing the psycho card is to their advantage, but Kenneth Adams, at Adams Drafting, thinks that an agreement permitting a party to act "in its sole discretion" is no excuse for the dissonant improvisation of unreasonable behavior.  Accordingly, he offers some pointers on drafting contract provisions invoking a party’s discretion.

Congress and the Federal health care regulatory agencies sometimes appear to be irrational to the outside observer.  My favorite judicial quote of all time picks up on this:

There can be no doubt but that the statutes and provisions in question, involving the financing of Medicare and Medicaid, are among the most completely impenetrable texts within human experience. Indeed, one approaches them at the level of specificity herein demanded with dread, for not only are they dense reading of the most tortuous kind, but Congress also revisits the area frequently, generously cutting and pruning in the process and making any solid grasp of the matters addressed merely a passing phase.

Rehabilitation Association of Virginia, Inc. v. Kozlowski, 42 F.3d 1444, 1450 (4th Cir. 1994).  Despite, or perhaps because of, this sort of characterization, the courts often leave the agencies alone in interpreting and implementing their rules.  This week, however, Greg Piche’, at Holland & Hart’s Health Care Law Blog, writes about a recent Second Circuit decision that actually struck down the implementation of a Medicare reimbursement rule regarding payment for implantation of medical devices as arbitrary and capricious. 

Blawgers and other bloggers sometime find that other people think they’re crazy ("playin’ different tunes," to quote a dinosaur of rock); occasionally they’re sued for defamation — sometimes even for comments posted by third parties.  For the latest on blog owner do’s and don’ts, liability for defamation by commenter, and blogging liability insurance, see Blogs and the Law at Jen Burke’s Transcending Gender.

Bloggers stick together in order to find others who don’t think they’re nuts.  An old friend of mine likes to say that people stick together in smaller and smaller affinity groups (her favorite example of a hypothetical small group is left-handed Jewish lesbian redheaded Cuban feminists).  The first Healthcare Blogging Summit, organized by Dmitry Kruglyak of The Medical Blog Network took place recently in D.C.  While the world of healthcare blogging or the world of blawging may represent a veritable orchestra full of virtuosos (virtuosi?), health blawging seems to be limited to a band of a dozen or so soloists, woodshedding, as it were.  One of those who summitted was Bob Coffield, a health blawger who posted some post-summit updates in his pre-summit Health Care Law Blog post. 

Newman_gallery7_1 I’ll leave you with one my favorite pianist photographs, Arnold Newman’s portrait of Igor Stravinsky.  Stravinsky’s music is famously complex, some of it atonal, but one of his views on composition reveals a simple fortuity inherent in the work:  "One has a nose. The nose scents and it chooses. An artist is simply a kind of pig snouting truffles."

Have a good week, and in the spirit of the musicians who inspired this week’s edition of Blawg Review, I wish you luck in balancing intentionality and chance in your work and life.

Blawg Review has information about next week’s host, and instructions how to get your blawg posts reviewed in upcoming issues.

— David Harlow

MA Medical Law Report

Lawyers Weekly puts out a quarterly Massachusetts Medical Law Report geared to physicians and health care administrators.  The current issue (PDF) features a number of my colleagues around town — Bill Mandell, Eve Horwitz, Carol Phillips, Michael Costa — and a quote from me in the article on CMS’s pay for performance demonstration beginning on the bottom of page one.

— David Harlow