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.

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.

From the Marian Gallagher Law Library at the University of Washington:

FOOD AND DRUG LAW

• Havinga, Tetty. Private regulation of food safety by supermarkets. 28 Law & Pol'y 515-533 (2006). [L][W]
• Hixson, Timothy J. Note. Anti-depressants and children: suicidality, off-label use, and trial publication. 3 Ind. Health L. Rev. 201-230 (2006). [L][W]
• Meek, Travis P. Note. Proper preemption or contrived construction?: why section 360k(a) of the FDCA should not be interpreted to preempt state common law tort claims. 3 Ind. Health L. Rev. 231-262 (2006). [L][W]

HEALTH LAW AND POLICY

• McDonald-Merrill-Ketcham Memorial Award for Excellence in Law and Medicine. 3 Ind. Health L. Rev. xvii-xxi, 1-169 (2006).
• History. 3 Ind. Health L. Rev. xvii (2006).
  Recipients. 3 Ind. Health L. Rev. xix-xx (2006).
  [Author biography.] 3 Ind. Health L. Rev. xxi (2006).
• Bovbjerg, Randall R. Beyond tort reform: fixing real problems. 3 Ind. Health L. Rev. 1-26 (2006). [L][W]
• [Author biographies.] 3 Ind. Health L. Rev. 27-31 (2006). [L][W]
• Frech, H.E. III, William G. Hamm and C. Paul Wazzan. Controlling medical malpractice insurance costs--congressional act or voter proposition? 3 Ind. Health L. Rev. 32-41 (2006). [L][W]
• [Author biography.] 3 Ind. Health L. Rev. 43 (2006). [L][W]
• Mitchell, John B. My father, John Locke, and assisted suicide: the real constitutional right. 3 Ind. Health L. Rev. 45-101 (2006). [L][W]
• [Author biographies.] 3 Ind. Health L. Rev. 103 (2006). [L][W]
• Spece, Roy G., Jr. and John J. Marchalonis. Sound constitutional analysis, moral principle, and wise policy judgment require a clear and convincing evidence standard of proof in physician disciplinary proceedings. 3 Ind. Health L. Rev. 105-135 (2006). [L][W]
• [Author biography.] 3 Ind. Health L. Rev. 137 (2006). [L][W]
  Trubek, Louise G. New governance and soft law in health care reform. 3 Ind. Health L. Rev. 139-169 (2006). [L][W]
• Edwards, Deborah C. Note. Duty-to-warn--even if it may be hearsay? The implications of a psychotherapist's duty-to-warn a third person when information is obtained from someone other than his patient. 3 Ind. Health L. Rev. 171-200 (2006). [L][W]
• Hixson, Timothy J. Note. Anti-depressants and children: suicidality, off-label use, and trial publication. 3 Ind. Health L. Rev. 201-230 (2006). [L][W]
• Meek, Travis P. Note. Proper preemption or contrived construction?: why section 360k(a) of the FDCA should not be interpreted to preempt state common law tort claims. 3 Ind. Health L. Rev. 231-262 (2006). [L][W]
• Murray, Tammy R. Note. State innovation in health care: Congress' broad spending power under a national health care system will stifle state laboratories of democracy. 3 Ind. Health L. Rev. 263-301 (2006). [L][W]

MEDICAL JURISPRUDENCE

• Cacciaguidi-Fahy, Sophie. Creating legal space for the unborn. 19 Int'l J. Semiotics L. 275-292 (2006). [L][W]
• Cooley, Christina. Student article. Maximizing patient autonomy through expanded medical surrogacy mediation. 30 Law & Psychol. Rev. 229-251 (2006). [L][W]
• Matthew, Eric S. Student article. A new prescription: how a thorough diagnosis of the "medical malpractice" amendments reveals potential cures for Florida's ailing citizen initiative process. 14 U. Miami Bus. L. Rev. 331-357 (2006). [L][W]
• McConnell, Brooke. Quality control: the implications of negative genetic selection and pre-birth genetic enhancement. 15 UCLA Women's L.J. 47-70 (2006). [L][W]
• Thomas, Sue, Lisa Rickert and Carol Cannon. The meaning, status, and future of reproductive autonomy: the case of alcohol use during pregnancy. 15 UCLA Women's L.J. 1-46 (2006). [L][W]

[L] = Lexis/Nexis link
[W] = WestLaw link

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.

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.

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.

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.

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.

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.

From the Marian Gallagher Law Library at the University of Washington:

FOOD AND DRUG LAW

• Butler, Lisa. Comment. A "heartless" decision: why pre-market approval does not preempt all state tort claims against medical device manufacturers. (Horn v. Thoratec Corp., 376 F.3d 163, 3d Cir. 2004.) 80 St. John's L. Rev. 753-787 (2006). [L][W]
• Jones, Amanda M. Casenote. How the medical marijuana debate invoked Commerce Clause confusion. (Gonzales v. Raich, 125 S. Ct. 2195, 2005.) 28 U. Hawai`i L. Rev. 261-293 (2005). [L][W]
• Law, Marc T. How do regulators regulate? Enforcement of the Pure Food and Drugs Act, 1907-38. 22 J.L. Econ. & Org. 459-489 (2006). [L][W]
• Wacek, Bartholomew C. Comment. Taking sides in the vaccine/autism legal battle. 8 DePaul J. Health Care L. 305-327 (2004). [L][W]

HEALTH LAW AND POLICY

• Antalis, Zachary. Recent development. Hawai`i Patients' Bill of Rights: saving the right to external review. 28 U. Hawai`i L. Rev. 295-322 (2005). [L][W]
• Grudzien, Larry. The great vanishing benefit, employer provided retiree medical benefits: the problem and possible solutions. 39 J. Marshall L. Rev. 785-825 (2006). [L][W] \
• Hermer, Laura D. The scapegoat: EMTALA and emergency department overcrowding. 14 J.L. & Pol'y 695-733 (2006). [L][W]
• Ice Miller LLP. Survey of recent developments in health law. 39 Ind. L. Rev. 1051-1104 (2006). [L][W]
• Jones, Amanda M. Casenote. How the medical marijuana debate invoked Commerce Clause confusion. (Gonzales v. Raich, 125 S. Ct. 2195, 2005.) 28 U. Hawai`i L. Rev. 261-293 (2005). [L][W]
• Klaff, Daniel B. Evaluating work: enforcing occupational safety and health standards in the United States, Canada, and Sweden. 7 U. Pa. J. Lab. & Emp. L. 613-659 (2005). [L][W]
• Lau, Jeff A. Comment. Reconsidering Hawai`i's HIV statute: the need to protect an individual's basic liberties. 28 U. Hawai`i L. Rev. 169-199 (2005). [L][W]
• Sprague, Aileen and Fidelma Fitzpatrick. Getting the lead out: how public nuisance law protects Rhode Island's children. 11 Roger Williams U. L. Rev. 603-649 (2006). [L][W]
• Sulentic, Alison McMorran. Can systems analysis help us to understand C.O.B.R.A.?: A challenge to employment-based health insurance. 39 J. Marshall L. Rev. 753-784 (2006). [L][W]
• Symposium Issue: Exploring Employee Health and Safety: The Occupational Safety and Health Act and the Mine Safety and Health Act. Articles by Kenneth D. Kleinman, John F. Ward, John Howard, M.D., and Eugene Scalia. 7 U. Pa. J. Lab. & Emp. L. 487-538 (2005). [L][W]

MEDICAL JURISPRUDENCE

• Ellis, Alicia A. Note. Better late than never: New York finally closes the "gap" in recovery permitted for negligent infliction of emotional distress in prenatal medical malpractice cases. (Broadnax v. Gonzalez, 2 N.Y.3d 148, 809 N.E.2d 645, 777 N.Y.S.2d 416, 2004.) 80 St. John's L. Rev. 725-751 (2006). [L][W]
• Emery, Ryan T. Comment. Unwise and unnecessary statutory caps on non-economic damages in medical malpractice cases and the appellate review alternative. 69 Alb. L. Rev. 913-946 (2006). [L][W]
• Nero, Autumn. Note. Where are we NOW? Clinic protection in the wake of ... (NOW v. Scheidler (NOW III), 126 S. Ct. 1264, 2006; NOW v. Scheidler (NOW II), 537 U.S. 393, 2003; NOW v. Scheidler (NOW I), 510 U.S. 249, 1994.) 21 Wis. Women's L.J. 73-109 (2006). [L][W]
• Weeden, L. Darnell. ERISA's preemption ruling prevents a patient from suing an HMO under state malpractice law: after Aetna Health, Inc. v. Davila who will grant the working middle class a meaningful right to be heard? 7 U. Pa. J. Lab. & Emp. L. 715-745 (2005). [L][W]
• Science for Judges VI: Techniques for Evidence-Based Medicine. Introduction by Margaret A. Berger; articles by Daniel M. Fox, Lee Greenfield, Mark Gibson, Lisa A. Bero, Jeffrey C. Lerner and Diane C. Robertson. 14 J.L. & Pol'y 525-616 (2006). [L][W]

[L] = Lexis/Nexis link
[W] = WestLaw link

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. . . .

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.

From the Marian Gallagher Law Library at the University of Washington:

FOOD AND DRUG LAW

• Fritch, David M. Student article. Speak no evil, hear no evil, harm the patient? Why the FDA needs to seek more, rather than less, speech from drug manufacturers on off-label drug treatments. 9 J. Med. & L. 315-368 (2005). [L][W]
• Halper, Emanuel B. Evolution and maturity of the American supermarket during World War II. 41 Real Prop. Prob. & Tr. J. 253-356 (2006). [L][W]
• Mallon, Robyn. Student article. The deplorable standard of living faced by farmed animals in America's meat industry and how to improve conditions by eliminating the corporate farm. 9 J. Med. & L. 389-415 (2005). [L][W]
• Nichols, Kristen N. Student article. Nutraceuticals: in the realm of consumer protection, is the United States' regulation too much or not enough? 9 J. Med. & L. 369-388 (2005). [L][W]
• Wolfe, Sidney M., M.D. 2006 Schroeder Scholar in Residence Lecture. Worst pills, best pills. 16 Health Matrix 785-796 (2006). [L][W]

HEALTH LAW AND POLICY

• Luu, Arlene and Bryan A. Liaang. Case management: lessons from integrated delivery to promote quality care to the elderly. 9 J. Med. & L. 257-277 (2005). [L][W]

MEDICAL JURISPRUDENCE

• Forsythe, Clarke D. and Stephen B. Presser. Restoring self-government on abortion: a federalism amendment. 10 Tex. Rev. L. & Pol. 301-356 (2006). [L][W]
• Frech, H.E. III, William G. Hamm and C. Paul Wazzan. An economic assessment of damage caps in medical malpractice litigation imposed by state laws and the implications for federal policy and law. 16 Health Matrix 693-722 (2006). [L][W]
• Mastroianni, Anna C. Liability, regulation and policy in surgical innovation: the cutting edge of research and therapy. 16 Health Matrix 351-442 (2006). [L][W]
• Perry, Joshua E. Biblical biopolitics: judicial process, religious rhetoric, Terri Schiavo and beyond. 16 Health Matrix 553-630 (2006). [L][W]
• Shepherd, Lois. In respect of people living in a permanent vegetative state--and allowing them to die. 16 Health Matrix 631-691 (2006). [L][W]
• Van Voorhees, Alexander. Note. Truth in testing laws: a shot in the arm for designer gene tests. 16 Health Matrix 797-829 (2006). [L][W]

[L] = Lexis/Nexis link
[W] = WestLaw link

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.

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

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."

• 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

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).

• Consolidating Pharmaceutical Regulation Down Under: Policy Options and Practical Realities - Boston Univ. School of Law Working Paper No. 06-36, University of Queensland Law Journal, Vol. 26, No. 1, p. 111, 2006
  Frances H. Miller, Boston University School of Law
  Date Posted: September 26, 2006
  Last Revised:September 26, 2006
  Accepted Paper Series
  6 downloads
• Navigating the Social Safety Net: A State-Level Analysis of the Relationships Between Medicaid, the Uninsured and Consumer Bankruptcy
  Amy K. Yarbrough and Robert J. Landry III, College of Public Health and Health Professions, University of Florida and College of Commerce and Business Administration, Jacksonville State University
  Date Posted: September 26, 2006
  Last Revised:September 26, 2006
  Working Paper Series
  2 downloads
• Doctors & Juries - U of Missouri-Columbia School of Law Legal Studies Research Paper No. 2006-33
  Philip G. Peters Jr., University of Missouri at Columbia - School of Law
  Date Posted: September 20, 2006
  Last Revised: September 27, 2006
  Working Paper Series
  39 downloads
• Federalism, Federal Regulation, or Free Market? An Examination of Mandated Health Benefit Reform - U of Missouri-Columbia School of Law Legal Studies Research Paper No. 2006-32, University of Illinois Law Review, 2007
  Amy Monahan, University of Missouri at Columbia - School of Law
  Date Posted: September 20, 2006
  Last Revised: September 22, 2006
  Accepted Paper Series
  39 downloads
• In Sickness, Health, and Cyberspace: Protecting the Security of Electronic Private Health Information - Case Legal Studies Research Paper No. 06-15
  Sharona Hoffman and Andy Podgurski, Case Western Reserve University - School of Law and Case Western Reserve University
  Date Posted: September 20, 2006
  Last Revised: September 20, 2006
  Working Paper Series
  3 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
• Copayments in the German Health System - Do They Work? - RWI Discussion Paper No. 43
  Boris Augurzky, Thomas K. Bauer and Sandra Schaffner, Rhine-Westphalia Institute for Economic Research (RWI-Essen) - General , Rhine-Westphalia Institute for Economic Research (RWI-Essen) and RWI Essen
  Date Posted: September 8, 2006
  Last Revised: September 8, 2006
  Working Paper Series
  21 downloads

As previously noted here, Provena Covenant Medical Center last week lost its administrative appeal to the Illinois Department of Revenue of Champaign County's decision to revoke Covenant's tax-exempt status. The Department's September 29 ruling is available here (pdf).

For an extremely helpful analysis of all the issues -- prepared by Linda Sauser Moroney, a partner in the Milwaukee office of Gardner Carton & Douglas, and her colleagues T.J. Sullivan and Karen McAfee (partner and counsel to the firm, respectively, in its Washington office) -- go here (pdf).

Hurricane Katrina: Status of Hospital Inpatient and EmergencyDepartments in the Greater New Orleans Area. GAO-06-1003, September29. Report; highlights.

Summary findings:

While New Orleans continues to face a range of health care challenges, hospital officials in the greater New Orleans area reported in April 2006 that a sufficient number of staffed inpatient beds existed for all services except for psychiatric care -- some psychiatric patients had to be transferred out of the area because of a lack of beds. Overall, as of April 2006, the greater New Orleans area had about 3.2 staffed beds per 1,000 population, compared with the national average of 2.8 staffed beds per 1,000 population reported by the American Hospital Association. Hospital officials told us that they planned to open an additional 674 staffed beds by the end of 2006 -- 390 of which would be at University Hospital -- although they also reported that recruiting, hiring, and retaining nurses and support staff was a great challenge. With the addition of these beds, the population would have to increase from 588,000 in April 2006 to 913,000 by December 2006 before staffed beds would drop to the national average. For all types of care, eight of the nine hospitals we contacted provided us with an estimated overall occupancy rate for the 9-month period following the hurricane (through April 2006) and for the 12-month period before the hurricane. The hospitals’ occupancy rates for the 9-month period after the hurricane ranged from 45 percent to 100 percent, or an average of 77 percent, compared with a range from 33 percent to 85 percent, or an average of 70 percent, for the 12-month period before the hurricane. The American Hospital Association reported that the average monthly hospital occupancy rate nationwide was 67 percent in 2004. Eight of the nine hospitals that remained open after Hurricane Katrina also reported a high demand for services in their emergency departments, similar to the nationwide trend reported by the Institute of Medicine in June 2006 that emergency department crowding is a nationwide problem.

Today's NY Times had an article in the Business section on Abraxane -- in the words of the author, "a new version of an old cancer drug has helped make Dr. Patrick Soon-Shiong a billionaire":

The drug, Abraxane, does not help patients live longer than the older treatment, though it does shrink tumors in more patients, according to clinical trials. And the old and new medicines have similar side effects. An independent review of Abraxane published in December in a cancer research journal concluded that the drug was “old wine in a new bottle.”

Still, Dr. Soon-Shiong’s company, Abraxis BioScience, has promoted Abraxane as a major advance in treating late-stage breast cancer — that is, for patients who have not responded to other treatments and are now close to death —and is seeking approval for patients to use it earlier in their treatment. And, in at least one way, Abraxane is a breakthrough: it costs about 25 times as much as a generic version of the older medicine, which is best known by its brand name, Taxol.

Because of the odd economics of the cancer drug market, though, Abraxane’s price does not seem to be hurting its popularity.

About 20,000 people have now been treated with the drug, and Dr. Soon-Shiong expects its sales to approach $200 million this year. By 2010, Abraxane’s annual sales could reach $1 billion, analysts say.

Those rosy forecasts illustrate the pricing power that makers of cancer drugs wield. With patients often facing grim prognoses and desperate for new therapies, and insurers relatively powerless to negotiate prices or deny coverage, the cost of treatments seems to have little impact on demand.

The rise in cancer-drug prices is a microcosm of broader trends pushing up health care costs nationally. Despite decades of efforts by governments and insurers to restrain costs, patients continue to want the newest — and most expensive — drugs and medical devices. And doctors and the health care industry have little reason to keep costs in check, because insurers rarely deny coverage for new treatments on the basis of price.

As a result, health care costs continue to skyrocket. On Tuesday, the Kaiser Family Foundation reported that the cost of employee health insurance coverage rose 8 percent, according to a survey conducted from January to May this year. Businesses now spend about $8,500 a year for health insurance for the average family, the foundation said, with employees adding $3,000, not counting the cost of deductibles and other out-of-pocket payments.]

Abraxane, and cancer drugs generally, are still a tiny part of total medical spending. But their costs are rising even faster than overall health care inflation. Worldwide, spending on cancer drugs is expected to more than double from 2004 to 2009, to $55 billion, with most of that in the United States.

Largely as a result of investor enthusiasm for Abraxane, the stock market value of Abraxis is $4.6 billion. The company, which also makes several generic drugs used in hospitals, had a profit of $86 million last year on sales of $519 million. Dr. Soon-Shiong, the company’s chairman, owns 84 percent of the stock, worth about $3.8 billion.

What is wrong with this picture?

From the Marian Gallagher Law Library at the University of Washington:

HEALTH LAW AND POLICY

• Dresler, Carolyn and Stephen Marks. The emerging human right to tobacco control. 28 Hum. Rts. Q. 599-651 (2006). [L][W]

MEDICAL JURISPRUDENCE

• Barraza, Matthew. Note. Griswold, continued: after another failed attempt in the Legislature, should Utah family planning advocates turn to the courts for insurance coverage of birth control? 8 J.L. & Fam. Stud. 215-224 (2006). [L][W]
• Gunnison, Katherine Poste. Note. Poaching the eggs: courts and the custody battles over frozen embryos. 8 J.L. & Fam. Stud. 275-291 (2006). [L][W]

[L] = Lexis/Nexis link
[W] = WestLaw link