Some folks have a head for business . . . .

The AP reports (courtesy of MyWay) on an interesting case that lies at the intersection of criminal procedure and a patient's right to refuse an unwanted medical procedure. Seventeen-year-old Joshua Bush has a 9mm bullet in his head. Its presence isn't life-threatening, and a procedure to remove it wouldn't be any more dangerous than other surgeries that require general anesthesia. He has refused requests to have it removed, and is resisting a subpoena to obtain the bullet, presumably because it may link him to a robbery of a used car lot in which shots were exchanged. So who will win? The state, which has an interest in seeing an alleged shooter brought to justice? Or a person of interest to law-enforcement who would rather not have doctors poking around his head? Art Caplan says he thinks Bush will win. More on this later . . . . (Thanks to Maguire Center Coordinator Terri Gwinn for the tip.)

Piergiorgio Welby dies after respirator removed

The Italian poet who lost in his bid for court authorization to have his respirator removed (see earlier post), died after his physician removed the respirator without official permission (Reuters). Meanwhile, AP reports that prosecutors in Rome are looking into the details of Welby's death (AP/CBS News).

The death came the evening after an expert medical panel ruled Wednesday "that the use of a mechanical respirator 'does not constitute, as of now, extraordinary means.' But the panel also decided that precise guidelines for doctors were needed urgently to spell out what the law allows and what it does not" (International Herald Tribune). The Roman Catholic Curch in Italy has apparently already reached its own conclusions about Welby's death and earlier today denied his family's request for a church funeral (Reuters).

Italian poet pushes the law on his right to die

Today's New York Times has a story about Piergiorgio Welby, an Italian poet who apparently has entered the final chapter in his 40-year fight with muscular dystrophy. His breathing is supported by a respirator and he may have a feeding tube (the article isn't crystal clear on this point), and he has asked for permission to have his respirator removed. Italian authorities have so far said no:

“I love life, Mr. President,” Mr. Welby, 60, who has battled muscular dystrophy for 40 years, wrote to Italy’s president, Giorgio Napolitano, in September. “Life is the woman who loves you, the wind through your hair, the sun on your face, an evening stroll with a friend.

“Life is also a woman who leaves you, a rainy day, a friend who deceives you. I am neither melancholic nor manic-depressive. I find the idea of dying horrible. But what is left to me is no longer a life.”

Now Mr. Welby’s long drama appears to be nearing its final act. Last weekend, an Italian court denied legal permission for a doctor to sedate him and remove him from his respirator. Fully lucid but losing his capacity to speak and eat, he is deciding whether to appeal or to perform an act of civil disobedience that will kill him.

The article says that Italian law allows patients to refuse unwanted medical treatments but is unclear as to the right of a physician to participate. That's confusing enough, but what the article says about the Catholic Church's position in this case is more so:

The church, too, has conflicting teachings about what to do in this case, and what the Vatican thinks has a deep impact not only on the nation’s political class but also on doctors tied to the scores of Catholic-run hospitals around Italy.

The defense of life is central to the social doctrine of the church, and so it opposes abortion and capital punishment. Only last week Pope Benedict XVI reaffirmed his opposition to euthanasia, saying governments should find ways to let the terminally ill “face death with dignity.”

The church also opposes medical treatments to artificially prolong life, but several church officials have worried recently that ending artificial life support could result in de facto euthanasia.

“The problem is to know if we find ourselves truly in front of a case of an artificial prolonging of life,” Cardinal Javier Lozano Barragán, the Vatican’s top official for health, said in a recent interview with La Repubblica.

I had thought that the Catholic Church had long ago accepted that patients could refuse "extraordinary" treatments, even life-sustaining ones, and that one of the defining notions behind "extraordinary" is that the treatment merely prolongs the dying process. Granted, "prolongation" may be in the eye of the beholder, but Welby's death appears to be reasonably imminent with or without life-supporting measures and so it should be a relatively easy one for Church leaders. Or am I missing something?

Links for more information about this case:

• BBC article with useful links to related stories
• Pope Benedict XVI's Dec. 8 remarks about caring for the incurably ill
  

Federal pre-emption of state-law claims medical-device manufacturers

This issue keeps turning up on SCOTUS' docket every few years like the proverbial bad penny. Most recently, it takes the form of Riegel v. Medtronic, No. 06-179. The petition for certiorari to the Second Circuit is pending, and after it was considered by the Court at its Nov. 3 conference, the justices invited the Solicitor General's office (on Nov. 6) to file a brief addressing the cert-worthiness of the case (known in the parlance of the trade -- the Supreme Court advocacy trade, that is -- as a CVSG (a "call for the views of the Solicitor General"). When the SG's brief is filed, it will be posted here. Thanks to Aaron Streett's excellent (and wickedly irreverent) Supreme Court e-mail newsletter for this bit of intelligence (subscription requests to "SCt Today" may be sent here).

The opening paragraphs of the Second Circuit's 2-1 opinion tell the tale nicely:

This case calls upon us to determine, inter alia, the scope of the preemption provision set forth in Section 360k(a) of the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et. [sic] seq. [link]Specifically, we must decide whether Section 360k(a) preempts common law tort claims regarding medical devices that have entered the market pursuant to the Food and Drug Administration’s (“FDA”) rigorous premarket approval (“PMA”) process. The Supreme Court left open this question in Medtronic v. Lohr, 518 U.S. 470 (1996) [link], which held that tort claims as to medical devices that have entered the market pursuant to the far less intensive premarket notification process (often referred to as the “Section 510(k) process”) are not preempted by Section 360(k)(a) [sic]. Since Lohr, the majority of circuits addressing this question have held that claims regarding PMA-approved medical devices are, by contrast, preempted. See Horn v. Thoratec Corp., 376 F.3d 163 (3d Cir. 2004); Martin v. Medtronic, Inc., 254 F.3d 573 (5th Cir. 2001); Brooks v. Howmedica, Inc., 273 F.3d 785 (8th Cir. 2001); Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir. 2000); Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir. 1997); but see Goodlin v. Medtronic, Inc., 167 F.3d 1367 (11th Cir. 1999).

We now join this growing consensus and hold that tort claims that allege liability as to a PMA-approved medical device, notwithstanding that device’s adherence to the standards upon which it obtained premarket approval from the FDA, are preempted by Section 360(k)(a)[sic]. . . .

So there is a slight split in the circuits, more of a fissure, really, and the Court has asked the SG's office to offer some guidance on the need for the Court to clear up the confusion (whichever side might be said to be confused). Stay tuned . . . .

It's been a long time . . .

. . . not just a long time, actually: It's been a of a long time since my last post, due mostly to conferences and speeches the past few weeks at the Maguire Center for Ethics, combined with some speechifying of my own, on top of teaching, cranking out a new poetry column for the Dallas Morning News (scheduled for this Sunday's paper), and a few other official chores PLUS(arthroscopic surgery on a torn medial meniscus) . . . .okay, okay -- too much information. Well, I'm back, at least until we leave for Paris to visit #3 son (with #2 son in tow) next week, which means this page will be down for about 5 days startingNov. 23. For now -- For a day or two, I'll be playing a little catch-up ball to get through the backlog of interesting or useful (and in some case, useful and interesting) stuff. Stay tuned . . . .

Bones and tissue stolen by undertakers and sold illegally

This CNN story is just the latest in a long line of exposés of the apparently irremediably corrupt bones-and-tissue market. How long can this business go without significant regulation? USA Today had a good report on the situation in June 2006. The illustration to the right, by the way, shows an X-ray of a corpse whose leg bones were surreptitiously removed and replaced with household PVC pipe, as reported in the CNN story.

Porter & Teisberg's "Redefining Health Care" gets raked over the coals

I was impressed by Michael Porter's and Elizabeth Olmstead Teisberg's article-length adaption of their health-care policy book when the article appeared in the June 2004 issue of the Harvard Business Review. Now the book is out, and judging from the lukewarm (at best) response over on the Health Affairs blog, it is either not up to the standards one might expect from one of Harvard's 21 University Professors or exactly what you'd expect from a really bright guy who's long on theory and short on real-world health-care experience.

The blog entries are all listed here and include commentary from Gail Wilensky, Alan Maynard, Alan Enthoven, Uwe Reinhardt, and a slightly more upbeat James C. Robinson. Health Affairs' review of the Porter & Teisberg tome (wirtten by Tom Miller) is here.

Widener seeking new director of health law program

Widener School of Law is looking for a director for their health law program. Here are the specs:

Widener University School of Law (Wilmington, DE campus) is seeking an experienced teacher and scholar to direct our nationally prominent Health Law Institute. Administrative experience is also desirable, but not necessarily required. The Director will be responsible for working with other health law faculty and administrative staff to develop new initiatives that can move the Institute forward. Among the expected responsibilities will be:

* planning conferences and symposia;
* creating new externship opportunities and expanding existing relations;
* working with the development office to identify and pursue granting and other giving opportunities;
* continuing to produce a high level of important scholarship;
* demonstrating leadership skills that will inspire other faculty members to engage fully in the Institute’s mission;
* teaching primarily health law courses (with a reduced teaching load).

Although candidates with backgrounds in any area of health law will be considered, we are especially interested in candidates who specialize in the financial and transactional aspects of health law and health care. A secondary area of interest is public health law. We are committed to increasing and improving the diversity of our faculty. Accordingly, we strongly urge members of historically excluded or disadvantaged groups to apply. Please direct replies to Professor John Culhane at: johnculhane@earthlink.net.

Latest from AHLA's Health Lawyers Weekly (20 Oct 2006)

From the excellent Health Lawyers Weekly (AHLA member benefit), here's the table of contents from the October 20 issue:

Top Stories

• OIG Confirms Compliance Guidance Applies To Physician Investments In Medical Device Firms -- Compliance guidance on joint ventures involving physician investors applies to medical device and distribution entities, said the Department of Health and Human Services Office of Inspector General (OIG) in an October 6 letter responding to a request for more guidance in this area. Full Story
• CMS Releases Expanded List Of Potential Quality Measures For 2007 Medicare Physician Voluntary Reporting Program -- The Centers for Medicare and Medicaid Services (CMS) has posted on its website a list of eighty-six quality measures that it expects to be available in 2007 for its Medicare Physician Voluntary Reporting Program (PVRP), according to the agency's October 16 fact sheet. Full Story

Articles & Analyses

• Employed Physicians And Independent Contractors: A Brief Overview: Matthew C. Jones and Paul D. Snitzer, Duane Morris LLP

Current Topics

• Employment and Labor
  Seventh Circuit Finds Non-Board Certified Surgeon Failed To Prove Racial Discrimination After His Application For Active Status Was Not Approved
• EMTALA
  U.S. Court In Puerto Rico Dismisses Patient's EMTALA Suit, Agreeing Claim Is "Artfully Pleaded Medical Malpractice"
• Food and Drug Law
  URAC Releases First Draft Standards For Accreditation Of Pharmacy Benefit Managers
• Fraud and Abuse
  1. Eighth Circuit Affirms $500,000 Fine Against Ambulance Transfer Service For Filing False Claims
  2. OIG OKs Network Organizer's Variable Compensation Arrangement With Marketing Firm That Generates Minimal Federal Healthcare Program Business
  3. Washington High Court Finds State Antikickback Law Does Not Prohibit Physicians From Dispensing Prescription Drugs To Patients For A Profit
  4. Update
• Health Information Technology
  NGA Launches State Alliance To Advance HIT
• Healthcare Access
  Job-Based Health Coverage Declines Nearly 4% Over Last Five Years, As Uninsured Population Grows
• Individual/Patient Rights
  Louisiana Supreme Court Finds Lower Court Erred In Awarding Damages On Lack Of Informed Consent Claim
• Medicaid
  1. Maryland High Court Says Minors Who Are Resident Legal Aliens Entitled To Preliminary Injunction After State Cut Medical Assistance Benefits
  2. OIG Finds $27.3 Million In Medicaid Overpayments For Deceased Beneficiaries
  3. States Need Additional Guidance In Addressing Medicaid Third-Party Liability Issues, GAO Says
• Medical Malpractice
  1. Iowa Appeals Court Upholds Ruling That Medical Malpractice Suit Was Time Barred By Applicable Statute of Limitations
  2. Hawaii Appeals Court Overturns Dismissal Of Medical Malpractice Suit, Finds Issues Of Material Fact On When Patient Should Have Discovered Physician's Alleged Negligence
• Medicare
  1.CMS Finalizes Methodology For Determining States' Part B Premium Allotments
  2. CMS Proposes To Make Part D Claims Data Available To Researchers
  3. CMS Implements Pay For Performance For Small Physician Practices
• News in Brief
  Former CMS Administrator McClellan To Join AEI-Brookings Joint Center
• Physicians
  1. Tennessee Appeals Court Affirms Arbitrator's Award In Diagnostic Center Dissolution Dispute
  2. California Appeals Court Rules Fraud Indictments Do Not Preclude Enforcement of Hospital's Relocation Agreement Against Physician
  3. Pennsylvania Appeals Court Finds Billing Manager's Presence At Peer Review Meetings Does Not Affect Applicability Of State's Peer Review Law
• Quality of Care
  CMS Implements Pay For Performance For Small Physician Practices
  Hospital Deaths Among Medicare Inpatients Fall, But "Quality Gap" Between High-Rated And Low-Rated Hospitals Widens, Study Says
• RICO
  Eighth Circuit Finds Medical Device Distributors Cannot Go Forward With RICO Claims

Copyright 2006 American Health Lawyers Association. Printed with permission.

If it could happen to Triad, it could happen to you

It's a sign of the times, I suppose: As health insurance becomes more expensive, more employers (especially small businesses and others that operate at the margins of profitability) drop health insurance, throwing more employees into the category of "self-pay" (unless they can afford coverage in the extravagantly priced individual-policy market), thus increasing the percentage of self-pay patients showing up at hospitals' doors, thus increasing the percentage of bad debt those hospitals carry (as a percentage of patient revenue). That is Triad Hospitals' explanation for third-quarter earnings that are 18 or 19 cents below analysts' expectations. The story is from Modern Healthcare's "Daily Digest" (requires paid subscription). Triad's press release is here.

Latest from AHLA's Health Lawyers Weekly (13 Oct 2006)

From the excellent Health Lawyers Weekly (AHLA member benefit), here's the table of contents from the October 13 issue:

Top Stories

• CMS Reduces Improper Claims By $1.3 Billion
  Improper Medicare claims payments were reduced $1.3 billion between 2005 and 2006, the Centers for Medicare and Medicaid Services (CMS) said October 12.The Medicare fee-for-service (FFS) error rate has declined from 14.2% in 1996 when the improper payment rate was first reported, to 5.2% in 2005, to the current 4.4% in 2006, CMS said in a press release. Full Story
• OIG Finds DME Manufacturer's Proposal To Offer Suppliers Free Advertising Problematic
  A proposed arrangement in which a durable medical equipment (DME) manufacturer would provide free advertising and reimbursement consulting services to some of its DME supplier customers could generate prohibited remuneration under the Anti-Kickback Statute and potentially trigger administrative sanctions, according an advisory opinion posted October 10 by the Department of Health and Human Services Office of Inspector General (OIG). Full Story

Articles & Analyses

• FDA Updates Compliance Program For Inspecting Medical Device Manufacturers, by Edward M. Basile and Mark S. Brown, King
  & Spalding LLP

Current Topics

• Food and Drug Law
  Settlement Between Publisher Of Prescription Drug Prices And Consumer Advocacy Group Calls For Ceasing Publication Of AWP Drug Pricing Data
• Fraud and Abuse
  1. U.S. Court In California Finds FCA Public Disclosure Bar Requires Dismissal Of Qui Tam Complaint
  2. OIG Approves Company's Agreement To Act As Pay-For-Performance Payment Administrator For State Medicaid Agency
  3. Update
• Health Information Technology
  1. U.S. Court In District Of Columbia Finds Association Lacks Standing To Sue DHHS Over Creation Of IT Advisory Committee
  2. Standard Definition Of EHR Key To Establishing Reliable Benchmarks Of Use, Report Says
• Healthcare Spending
  Estimates Show Employers' Average Healthcare Costs To Increase 7.7% In 2007
• Hospitals and Health Systems
  Montana High Court Allows New License For Specialty Hospital That Changed Its Status To General Hospital
• Medicaid
  1. OIG Finds Most Surveyed States Did Not Routinely Verify DME Providers Met Medicaid Enrollment Standards
  2. Medicaid Spending Growth Slows To Lowest Point In Ten Years
• Medical Malpractice
  Florida Appeals Court Allows Medical Malpractice Lawsuit Against Hospital Based On Independent Contractor Physician's Alleged Negligence
• Medicare
  1. CMS Should Change Method Of Allocating MIP Funds, GAO Finds
  2. U.S. Court In Texas Finds Medicare Contractor Failed To Exhaust Administrative Remedies
  3. U.S. Court In Pennsylvania Finds Nonprofit Hospital Merger Was Not A Related-Party Transaction
  4. State Medicaid Directors Urge CMS To Revisit Calculation Of State Part D Payments
• News in Brief
  CMS Says Fraud Fighting Efforts Save Billions
• Physicians
  1. U.S. Court In West Virginia Says Hospital Entitled To HCQIA Immunity From Physicians' Claims
  2. U.S. Court In New York Dismisses Physician's HCQIA And RICO Claims Against Hospital That Terminated His Privileges
• PRRB
  1. PRRB Hearing Decisions Recap
  2. CMS Administrator Decisions Recap
  3. Jurisdictional Determinations Recap
• Tax
  1. Study Provides Nonprofit Hospitals Strategies For Measuring, Reporting Community Benefit
  2. CHA Releases New Community Benefit Resource
  3. Articles & Analyses
  
  Copyright 2006 American Health Lawyers Association. Printed with permission.

"The Massachusetts Plan and the Future of Universal Coverage"

That's the title of an upcoming conference (click here) and law review symposium issue (click here) at the University of Kansas School of Law. (Do I see the fine hand of old pal Gail Agrawal in this topic and the great lineup of speakers?) Thanks to Professor Elizabeth Weeks for the heads up on this one.

AHLA, Matyas & Valiant score with new edition of fraud and abuse classic

I wouldn't want to guess how many thousands of health lawyers have turned to one of the first two editions of Legal Issues in Healthcare Fraud and Abuse by David Matyas (who joined in on the 2nd edition) and Carrie Valiant, both of the Washington, D.C., office of Epstein, Becker & Green. Since its publication by AHLA in 1994, LIHFA has served as a primer on fraud and abuse issues for the newly minted healthcare lawyer and a quick desk reference for anyone looking for a leg up in his or her research on a specific issue.

The third edition has just been published, and I'm happy to report that it is a worthy successor to the first two editions. For a book that comes in at just under 500 pages, it is surprisingly comprehensive. It also doesn't scrimp on historical background and policy analysis and includes a useful chapter on the ethical and legal aspects of representing healthcare organizations in fraud and abuse matters.

Strong "buy" recommendation.

Back to the world of the living

I've been away for a little work on my damaged left knee. Sorry for the break in communications. I'll try to make up for lost time tonight and tomorrow. . . .

Falling into Medicare Part D's doughnut hole

Good editorial in the Oct. 6 N.Y. Times about the Part D Medicare pharmaceutical benefit. It omits one fact and misleadingly states another.

1. For some beneficiaries, the effect of the doughnut hole -- which leaves seniors paying 100% of their drug costs between $2250 and $5100 -- will be higher out-of-pocket costs after Part D became effective than before. For some, perhaps many or even most, Medicare beneficiaries -- including those whose drug use doesn't push them into the doughnut hole, as well as those whose utilization is at truly catastrophic levels, where Plan D kicks back in and covers 95% of drug costs -- Part D will be a boon. But it's promise is false for many who fall into the doughnut hole and aren't "lucky" enough to have catastrophic levels of drug needs.

2. The Times says Medigap coverage can be purchased to insure the doughnut hole. That's only true, I believe, if the beneficiary's drug plan offers supplemental coverage, and many don't. In many other cases, seniors who were unaware of the implications of the doughnut hole chose a drug plan that didn't offer supplemental coverage and was therefore cheaper than another plan that did offer the supplemental coverage at a somewhat higher price. This is confusing for young, healthy law students in my health law class; imagine what confusion was out in the land when seniors were sorting and evaluating their options earlier this year.

Rationing flu vaccine: WSJ considers the ethics

Good discussion in a FREE online article over at the Wall Street Journal: "If We Must RationVaccines for a Flu,Who Calls the Shots?," by Sharon Begley. Here's the teaser:

You have 100 doses of a vaccine against a deadly strain of influenza that is sweeping the country, with no prospect of obtaining more. Standing in line are 100 schoolchildren and 100 elderly people.

The elderly are more likely to die if they catch the flu. But they also have fewer years left to live and don't get out enough to easily spread or catch the disease. The kids are more likely to act like little Typhoid Marys, sneezing virus over anyone they encounter, and have almost their whole life ahead of them. But they're also less likely to die if they get sick.

Whom do you vaccinate?

This dilemma is haunting experts concerned that avian influenza might start spreading from person to person instead of (as far as we know) mainly from birds to people. But it also applies to regular old flu, which always has the potential to reach pandemic proportions. In response, studies now are shedding light on the ethical issues and the most effective strategy for reducing illness and death if vaccine must be rationed. Sadly, they make a pretty good case that current U.S. policies leave a lot to be desired.

Latest from AHLA's Health Lawyers Weekly (06 Oct 2006)

From the excellent Health Lawyers Weekly (AHLA member benefit), here's the table of contents from the October 6 issue:

Top Stories

• Illinois Department Of Revenue Denies Nonprofit Hospital's Property Tax Exemption Renewal -- The nonprofit hospital, Provena Covenant Medical Center (Provena), does not qualify for the charitable institution tax exemption provided for under Illinois' property tax statutes because the hospital failed to provide sufficient evidence clearly demonstrating that it has met the statutory requirement to use its property primarily for charitable purposes, according to a final administrative decision issued September 29 by the Illinois Department of Revenue (IDOR). Full Story
• GAO Finds Weaknesses In CMS' Information Security Leave Sensitive Information Vulnerable -- Significant weaknesses in the Centers for Medicare and Medicaid Service's (CMS') electronic access and other system controls threaten the confidentiality and availability of sensitive financial and medical information, the Government Accountability Office (GAO) found in a new report. Full Story

Articles & Analyses

• The National Labor Relations Board Finally Provides Guidance On "Supervisors" Under The National Labor Relations Act: By John E. Lyncheski and Floyd A. Clutter, Cohen & Grigsby P.C.

Current Topics

• Food and Drug Law
  1. President Signs Homeland Security Spending Bill With Drug Importation Provision
  2. Lawmakers Introduce Legislation To Spur Approval Of Biogenerics
• Fraud and Abuse
  1. OIG, DOJ Release Annual Tally Of Anti-Fraud Efforts
  2. Update
  3. South Carolina Supreme Court Upholds State Statute Prohibiting Physician-Owned Physical Therapy Services Arrangements
  4. Omnicare To Pay $52.5 Million To Settle Medicaid Fraud Allegations In Michigan
• Healthcare Access
  California Governor Signs Legislation Directed At Making Drugs More Affordable For Low-Income And Uninsured
• Healthcare Spending
  Study Finds Steady Growth In Health Spending
• Legal Representation
  Florida Supreme Court Adopts Rule Allowing Medical Malpractice Claimants To Waive Their State Constitutional Right To Caps On Attorneys' Fees
• Long Term Care
  New Hampshire Supreme Court Finds Nursing Home Reimbursement Changes Invalid
• Medicaid
  1. CMS Announces Final DSH Allotment Amounts
  2. Tenth Circuit Finds Medicaid Statute Does Not Require States To Provide Certain Services To Developmentally Disabled
  3. DHHS Approves Funding For New York Healthcare Reform Initiative
  4. CMS Should Increase Financial Oversight Of Medicaid Program, Report Says
• Medical Malpractice
  Louisiana Appeals Court Finds Malpractice Damages Cap Unconstitutional
• Medicare
  1. U.S. Court In District Of Columbia Says DRA Retroactively Changed DSH Formula To Exclude Expansion Populations From Earlier Calculation
  2. CMS Posts Medicare's 2007 Drug Plan Options
  3. CMS Revises Wage Index For IPPS Rates
  4. CMS Says Majority Of Eligible U.S. Hospitals Satisfied FY 2007 Requirements For Voluntary Quality Reporting
  5. Appeals Court Grants Stay Of Order Enjoining CMS From Collecting Medicare Part D Premiums Mistakenly Refunded
  6. U.S. Court In Connecticut Dismisses Class Action Challenging DHHS' Denial of Medicare Coverage For Post-Hospital SNF Stays
• Physicians
  U.S. Court In Kansas Rejects Physician's Discrimination, Antitrust Claims Against Hospital Following Denial Of Medical Staff Reappointment
• Supreme Court
  1. Supreme Court Declines Review Of Third Circuit Ruling Rejecting Challenge To HIPAA Privacy Rule's "Routine Use" Exception
  2. Supreme Court Declines Review Of Rulings That Physicians' Antitrust Claims Against HMOs Not Subject To Arbitration
  3. Supreme Court Declines Review Eleventh Circuit Finding That Former Sales Employee Failed To Plead Fraud With Particularity
  4. Supreme Court Declines Review Of Eighth Circuit Decision Dismissing FCA Claim For Lack Of Specificity
  5. Supreme Court Leaves Standing Sixth Circuit Ruling That Qui Tam Plaintiff Failed To Plead Fraud With Particularity

(c) 2006 AHLA. Reprinted with permission

GAO: CMS' medical data susceptible to hackers

Here are a few opening paragraphs that ought to startle even the most jaded government bureaucrat:

Security weaknesses have left millions of elderly, disabled and poor Americans vulnerable to unauthorized disclosure of their medical and personal records, federal investigators said Tuesday.

The Government Accountability Office said it discovered 47 weaknesses in the computer system used by the Centers for Medicare and Medicaid Services to send and receive bills and to communicate with health care providers.

The agency oversees health care programs that benefit one in every four Americans. Its massive amount of data is transmitted through a computer network that is privately owned and operated.

However, CMS did not always ensure that its contractor followed the agency's security policies and standards, according to the GAO report released Tuesday.

"As a result, sensitive, personally identifiable medical data traversing this network are vulnerable to unauthorized disclosure," the federal investigators said. "And these weaknesses could lead to disruptions in CMS operations."

There is more here: AP/MyWay. The GAO report is here (pdf).

Oh, and back to the government bureaucrat who should be at least a little alarmed that there are 47 access points for hackers to gain access to the medical records of 1 out of 4 Americans. CMS administrator Mark McClellan -- who, with a Ph.D. in economics and an M.D., presumably knows when he is commenting on the story he wished he had read rather than the story that he was actually reading -- commented that the GAO "found no evidence that confidential or sensitive information had actually been compromised."

SSRN roundup: public health law (September 2006 additions)

• Governance, Microgovernance and Health - Temple Law Review, Vol. 77, p. 335, 2004
  Scott Burris, Temple University Beasley School of Law
  Date Posted: September 27, 2006
  Last Revised:September 27, 2006
  Accepted Paper Series
  3 downloads
• Regulatory Paradox in the Protection of Human Research Subjects: A Review of OHRP Enforcement Letters - Northwestern University Law Review, Vol. 101, No. 2, 2007, Temple University Legal Studies Research Paper
  Scott Burris and Jen Welsh, Temple University Beasley School of Law and Conrad O'Brien Gellman & Rohn, P.C.
  Date Posted: September 27, 2006
  Last Revised: September 27, 2006
  Accepted Paper Series
  4 downloads
• U.S. Health Researchers Review Their Ethics Review Boards: A Qualitative Study -
  Journal of Empirical Research on Human Research Ethics, Vol. 1, No. 2, pp. 39-58, 2006
  Scott Burris and Kathryn Moss,Temple University Beasley School of Law and University of North Carolina at Chapel Hill - Cecil G. Sheps Center for Health Services Research
  Date Posted: September 27, 2006
  Last Revised: September 27, 2006
  Accepted Paper Series
  2 downloads
• Between Charity, Welfare, and Warfare: A Disability Legal Studies Analysis of Privilege and Neglect in Israeli Disability Policy - Yale Journal of Law and the Humanities, Vol. 18, No. 2, Forthcoming
  Sagit Mor, University of Haifa - Faculty of Law
  Date Posted: September 15, 2006
  Last Revised: September 15, 2006
  Accepted Paper Series
  6 downloads
• Oy Canada! Trade's Non-Solution to 'the Problem' of U.S. Drug Prices - U of Maryland Legal Studies Research Paper No. 2006-31, American Journal of Law & Medicine, Vol. 32, pp. 247-277, 2006
  Daniel J. Gilman, University of Maryland - School of Law
  Date Posted: September 13, 2006
  Last Revised: September 26, 2006
  Accepted Paper Series
  11 downloads
• Why Understanding Smoking Bans is Important for Estimating their Effects: California's Restaurant Smoking Bans and Restaurant Sales
  Robert K. Fleck and F. Andrew Hanssen, Montana State University - Bozeman - Department of Agricultural Economics and Economics and Montana State University - Bozeman - Department of Agricultural Economics and Economics
  Date Posted: September 13, 2006
  Last Revised: September 23, 2006
  Working Paper Series
  10 downloads
• Gasping for Breath: The Administrative Flaws of the Federal Hazardous Air Pollutant Program - U of Houston Law Center No. 2006-W-01
  Victor Byers Flatt, University of Houston Law Center
  Date Posted: September 11, 2006
  Last Revised: September 27, 2006
  Working Paper Series
  6 downloads
• Private Regulation of Food Safety by Supermarkets - Law & Policy, Vol. 28, Issue 4, pp. 515-533, October 2006
  Tetty Havinga, Affiliation Unknown
  Date Posted: September 8, 2006
  Last Revised: September 8, 2006
  Accepted Paper Series
• Abortion, Equality, and Administrative Regulation - Columbia Public Law Research Paper No. 06-118, Emory Law Journal, Vol. 56, 2007
  Gillian E. Metzger, Columbia University - Columbia Law School
  Date Posted: September 8, 2006
  Last Revised: September 8, 2006
  Accepted Paper Series
• Is Public Health Paternalism Really Never Justified? A Response to Joel Feinberg - Oklahoma City University Law Review, Vol. 30, pp. 121-207, 2005
  Thaddeus Mason Pope, University of Memphis - Cecil C. Humphreys School of Law
  Date Posted: September 8, 2006
  Last Revised: September 8, 2006
  Accepted Paper Series
• Underage Drinking: Does Current Policy Make Sense? - Marquette Law School Legal Studies Paper No. 06-35, Lewis & Clark Law Review, Vol. 10, 2006
  Judi McMullen, Marquette University - Law School
  Date Posted: September 6, 2006
  Last Revised: September 6, 2006
  Accepted Paper Series
  11 downloads
• It Might Have Been: Risk, Precaution, and Opportunity Costs - Cornell Legal Studies Research Paper No. 06-023
  Douglas A. Kysar, Cornell University - School of Law
  Date Posted: September 5, 2006
  Last Revised: September 5, 2006
  Working Paper Series
  77 downloads
• Smoking and Externalities Regulation: Why Legislative Action has Gone too Far
  Tim Kowal, Chapman University - School of Law
  Date Posted: September 1, 2006
  Last Revised: September 10, 2006
  Working Paper Series
  1 downloads

NLRB rules most charge nurses are "supervisors"

In a potentially far-reaching opinion on September 29 (and released today), the NLRB (by a 3-2 vote) ruled that permanently assigned charge nurses are supervisors -- and therefore are a part of managment -- and ineligible for union membership. Here's the "Daily Digest" version of the story from Modern Healthcare:

The National Labor Relations Board ruled that certain full-time hospital charge nurses are supervisors and therefore ineligible to join unions in a case involving Oakwood Healthcare, Dearborn, Mich., and the United Auto Workers. The long-awaited decision creates a "broad new standard" for union membership, labor leaders said. The "immediate implications" of the case are "devastating to workers in the healthcare industry and potentially in other industries where professional employees direct or assign the work of others," AFL-CIO [link] President John Sweeney said in a statement [link].

The case is Oakwood Healthcare, Inc., No. 7–RC–22141 (pdf). It reverses a 2002 decision by the Acting Regional Director to include charge nurses in the bargaining unit, principally on the basis of the Supreme Court's decision in NLRB v. Kentucky River Community Care, 532 U.S. 706 (2001). In Kentucky River, another nurse-supervisor case, the Court rejected the Board's categorical exclusion from supervisor status of employees who exercise “ordinary professional or technical judgment in directing less-skilled employees to deliver services in accordance with employer-specified standards.” (This was the second time in a decade that the Court had spanked the NLRB for its analysis in a nurse-supervisor case. See NLRB v. Healthcare & Retirement Corp. of America, 511 U.S. 571, 579 (1994) (holding 5-4 that the Board erred in finding a nurse’s supervisory activity that was incidental to patient care was not exercised “in the interest of the employer”).)

Left to figure out what its standard should be after Kentucky River, the Board states: "exercising our discretion to interpret ambiguous language in the Act, and consistent with the Supreme Court’s instructions in Kentucky River, we herein adopt definitions for the terms 'assign,' 'responsibly to direct,' and 'independent judgment' as those terms are used in Section 2(11) of the Act. In a key paragraph, the Board writes:

Consistent with the Court’s Kentucky River decision, we adopt an interpretation of the term “independent judgment” that applies irrespective of the Section 2(11) supervisory function implicated, and without regard to whether the judgment is exercised using professional or technical expertise. In short, professional or technical judgments involving the use of independent judgment are supervisory if they involve one of the 12 supervisory functions of Section 2(11). Thus, for example, a registered nurse who makes the “professional judgment” that a catheter needs to be changed may be performing a supervisory function when he/she responsibly directs a nursing assistant in the performance of that work. Whether the registered nurse is a 2(11) supervisor will depend on whether his or her responsible direction is performed with the degree of discretion required to reflect independent judgment.

Webster's Third place a large role in the Board's analysis, which leads the Board to complain, somewhat defensively, "In interpreting those statutory terms, we do not, as the dissent maintains, blindly adopt 'dictionary-driven' definitions. Rather, we begin our analysis with a first principle of statutory interpretation that 'in all cases involving statutory construction, our starting point must be the language employed in Congress. . . . '"

Much is at stake in these cases involving professionals in the workplace, cases in which the Board is struggling to extend the scope of the NLRA -- a remedial statute -- but not beyond the limits of Congressional intent. As the dissenters point out:

Today’s decision threatens to create a new class of workers under Federal labor law: workers who have neither the genuine prerogatives of management, nor the statutory rights of ordinary employees. Into that category may fall most professionals (among many other workers), who by 2012 could number almost 34 million, accounting for 23.3 percent of the work force. “[M]ost professionals have some supervisory responsibilities in the sense of directing another’s work—the lawyer his secretary, the teacher his teacher’s aide, the doctor his nurses, the registered nurse her nurse’s aide, and so on" [quoting from NLRB v. Res-Care, Inc., 705 F.2d 1461, 1465 (7th Cir. 1983) (opinion by Circuit Judge Posner)].

In the view of the dissenting Board members, the Board has failed yet again:

If the National Labor Relations Act required this result — if Congress intended to define supervisors in a way that swept in large numbers of professionals and other workers without true managerial prerogatives—then the Board would be dutybound to apply the statute that way. But that is not the case. The language of the Act, its structure, and its legislative history all point to significantly narrower interpretations of the ambiguous statutory terms “assign . . . other employees” and “responsibly to direct them” than the majority adopts. The majority rejects what it calls a “results-oriented approach” in interpreting the Act. But the reasonableness of the majority’s interpretation can surely be tested by its real-world consequences. Congress cared about the precise scope of the Act’s definition of “supervisor,” and so should the Board. Instead, the majority’s decision reflects an unfortunate failure to engage in the sort of reasoned decision-making that Congress expected from the Board, which has the “primary responsibility for developing and applying national labor policy.” NLRB v. Curtin Matheson Scientific, Inc., 494 U.S. 775, 786 (1990).