It's a good time to be in cardiology

Two items from the print press, courtesy of Modern Healthcare's "Daily Dose":

• In Philadelphia, heart-transplant centers abound (Philadelphia Inquirer)
  After a massive heart attack last year, doctors told David Kaminstein that he needed a transplant. He had the choice of five hospitals in the Philadelphia area that could do the complicated operation. That's a lot of choices -- some say too many. With the launch of two new heart-transplant centers in recent years, this region has the same number of programs as Los Angeles, though just half the population. Last year, only the Hospital of the University of Pennsylvania -- with 49 transplants -- performed more than 13 of the operations. Most healthcare experts say that the more patients a transplant team treats, the better the results.
  
• Angioplasty rates off the charts in Ohio city (New York Times)
  People with blocked coronary arteries can typically choose among drugs, bypass surgery and vessel-clearing procedures like angioplasty. But in Elyria, a small, aging industrial city in northeast Ohio, doctors are much more likely than those anywhere else in the country to steer patients toward angioplasty. No one has accused the doctors involved of any wrongdoing. But the statistics are so far off the charts -- Medicare patients in Elyria receive angioplasties at a rate nearly four times the national average -- that Medicare and at least one commercial insurer are starting to ask questions. And the hospital where most of the procedures take place says it plans to conduct an independent review.

Medical liability insurers profiting handsomely in wake of Texas tort reform

Three years after tort reform hit the books in Texas, the state's medical liability insurers have lowered premiums somewhat and added enormously to their bottom line, according to a story in the August 11 issue of the Austin Business Journal. The largest of them all -- Texas Medical Liability Trust -- has shown the greatest gains:

The state's largest medical malpractice insurer -- Texas Medical Liability Trust, which is based in Austin -- may have the best post-tort reform success story.

In its 2005 annual report, TMLT detailed how, in just five years since 2001, its surplus has gone from $22.9 million to $203.4 million -- an increase of almost 800 percent. Over the same period, its assets almost doubled, going from $333.9 million in 2001 to $588.7 million last year. During the same time, however, its insurance losses went down by almost half, from $137.2 million in 2001 to $73.2 million last year.

And, the article continues, "Texas' second-largest doctor insurer, Fort Wayne, Ind.-based Medical Protective Corp., is doing well enough that last year it was bought by Berkshire Hathaway Inc., the legendary company run by the world's second-richest man, Warren Buffett."

More on emergency room practices

This from the East Bay Business Times in California . . . . Sutter Delta Medical Center, among others in the region, has cut waiting times in its ER from 4-6 hours to 1-2 hours. They've done it by being imaginative in their triaging of patients, getting noncritical patients to doctors faster than before, for instance. The hospital's director of emergency services says, "People are still using the ER as their primary-care provider. Our challenge was what kind of mechanism could we use to treat the nonemergency patients." Beats the daylights out of a brochure and a boot to the butt.

ER sends nonemergency patients packing

This might be a case of "dog bites man," but the Jacksonville Business Journal reports that area HCA hospitals have adopted the practice of screening emergency room patients (as required by EMTALA) and showing nonemergency patients the door (as permitted by EMTALA) with a brochure listing area clinics in their hands. Is this news, exactly? In my limited urban ER experience, you can sit in the waiting room on a Saturday or Sunday morning and watch one person after another get screened by a nurse who shows the BP/temp/pulse data to a doc and then gently but firmly escorts the almost-a-patient back out to the street. The more humane or enlightened institutions have an ambulatory care clinic to which the a-a-p can be directed, though most ACC's seem to be open only during regular business hours Mon.-Fri. Another common practice is to triage nonemergency ER patients to a non-acute treatment room within the emergency department. The brochure is a nice touch, though the article does quote someone who says the brochure has several inaccurate phone numbers and facility names.

Kaiser fined for mismanagement of its kidney-transplant program

Considering how neurotic the organ-transplant industry is to maintain a squeaky-clean image, it's remarkable that Kaiser Permanente's been hit with a massive fine from California's Department of Managed Health Care [press release] for mismanaging its kidney-transplant program. Even more significant, for my money, is the lesson here.

How many times has a health care provider tried to minimize the imposition of civil penalties by characterizing its lapses as "mere" record-keeping or bureaucratic errors, insisting all the while that no patient was put at risk and quality care wasn't compromised? My take on such evasions is that paperwork snafu's are typically the tip of the iceberg or (to mix my metaphors) the regulator's low-hanging fruit. If a place can't keep the administrative details straight, you can bet there's more to the situation than misplaced files and incomplete reports. Kaiser's situation is a good example:

Kaiser suspended its Northern California kidney transplant program in May amid mounting regulatory pressure and patient lawsuits alleging that botched paperwork and administrative errors had imperiled lives.

Problems arose when Kaiser ordered Northern California kidney patients to transfer from University of California hospitals to its new transplant center in 2004.

Kaiser failed to discuss with regulators the transfer of up to 1,500 patients to the new center, delaying some patients' procedures, the Los Angeles Times reported. Only 56 transplants were performed at the Kaiser's San Francisco center in 2005, while twice that number of people died waiting for a kidney, the Times reported.

At other California transplant centers, more than twice as many people received kidneys than died.

Lucinda Ehnes, director of the managed care department, said Kaiser's administrative oversight was inadequate and it provided too few personnel to accomplish the transfers.

The company also failed to provide timely access to specialists and did not properly respond to patient complaints, she said.

Mary Ann Thode, president of Kaiser Foundation Health Plan and Hospitals in the Northern California region, said the HMO deeply regretted "any problems, difficulties or concerns we may have caused any of our patients as a result of their experience."

"Problems," "difficulties," and "concerns" are corporate euphemisms for the likely loss of lives of patients who placed their faith in Kaiser. But give Kaiser credit: it isn't engaging in the usual evasions about "mere errors in the paperwork," but is instead taking responsibility and vowing to do better in the future.

Costly Drugs Force Life-Death Decisions

From the AP, a good story about the costly, high-tech armamentorium of drugs and devices that offer the promise of extending life-spans once deemed to be "terminal," but at a price that's so high, some patients simply opt out:

More patients are confronting this wrenching decision, as the latest generation of pricier cancer drugs and heart implants stretches out the final months of advanced disease. Is the chance for several more months of life - maybe a year or more with luck - precious enough to spend a small fortune? This dilemma is also challenging governments, employers and insurers, who all help finance America's longer life spans and innovative technologies.

Extraordinary care for dying patients can make for inspiring medicine, but its extraordinary costs make it an increasingly debated choice to promote public health. Many economists, doctors, and ethicists say this care too often buys too little for too much - and that its expanding share of medical resources might better pay for screening and treating diseases in earlier stages.

Already, up to 30 percent of annual payments by federal Medicare insurance go to the 5 percent of members in their last year of life, research shows.

"People still have an underlying belief that there's an infinite amount of resources that can be invested in health care," says Dr. Harlan Krumholz, a Yale University heart specialist who studies quality of care. "But I think we're coming to a realization that we're going to need to confront these issues explicitly."

Maybe so, but any retreat from last-resort care still raises objections from many patients, doctors and medical companies. They denounce "rationing" of care and defend expensive treatments for the dying as a moral imperative.

More on non-heart-beating organ donors

"NHBD" is slowly being replaced by "DCD" ("donation after cardiac death"), but whatever name it goes by, these organ-donor protocols continue to get (deservedly) close scrutiny, most recently in the New Scientist. The move away from brain death and toward cardiopulmonary death is, contrary to the implications of this article, not evidence of a "new" standard for determining when death occurs, but rather is a return to the old way of determining death. Most states retained cardiopulmonary death when they adopted brain death, so no change in law is needed except in the few states that made neurological criteria the sole standard for determining when death occurs. The real concerns -- and this is brought out in the article -- are over whether the existing protocols run roughshod over the the requirement that the absence of cardiac and pulmonary function be irreversible and whether the administration of regitine and heparin cause the cessation of cardiopulmonary function. For more on all this, a good place to start is the 1997 IOM report, "Non-Heart-Beating Organ Transplantation: Medical and Ethical Issues in Procurement."

Latest from AHLA's Health Lawyers Weekly (11 Aug 2006)

With the permission of the American Health Lawyers Association, here's this week's Table of Contents for its Health Lawyers Weekly (free member benefit):

Top Stories

• CMS Projects 5.1% Reduction In Medicare Physician Payment Rates For 2007: The Centers for Medicare and Medicaid Services (CMS) is projecting a negative 5.1% update in the Medicare physician fee schedule for 2007 under the Sustainable Growth Rate (SGR) formula, according to a proposed rule released August 8.Under the proposal, CMS expects payments of roughly $61.5 billion to 875,000 physicians and other healthcare professionals in 2007. Full Story
• CMS Issues Proposed OPPS Rule Containing Significant Revisions To ASC Payment: Hospitals will receive an overall average increase in Medicare payments of 3% in calendar year (CY) 2007 for outpatient services under the proposed hospital outpatient prospective payment system (OPPS) rule issued August 8 by the Centers for Medicare and Medicaid Services (CMS). Full Story

Articles & Analyses

• New IRS Independent Contractor Test, By Sidney S. Welch and Tizgel K. S. Mark, Powell Goldstein LLP
• 2005-2006 Physician Organizations Year In Review, Compiled by Health Lawyers' Physician Organizations Practice Group
• 2005-2006 Regulation, Accreditation, And Payment Year In ReviewCompiled by Health Lawyers' Regulation, Accreditation, And Payment Practice Group

Current Topics

• Antitrust
  U.S. Court In Missouri Says Medical Group's Antitrust Suit Against Hospital Failed To Allege Relevant Geographic Market
• EMTALA
  U.S. Court In Missouri Dismisses EMTALA Claim, Finding No Evidence That Uninsured Patient Was Treated Differently
• Food and Drug Law
  GlaxoSmithKline Agrees To Pay $70 Million To Settle AWP Dispute
• Fraud and Abuse
  1. U.S. Court In Nevada Finds No Fact Issue Regarding Whether Government Knew Of FCA Defendant's Billing Practices
  2. U.S. Court In Nevada Finds Government Failed To Establish FCA Claims Alleging Physician Improperly Billed Medicare For Tests
• Health Policy
  Tommy Thompson Issues Paper Urging Medicaid Program Reform
• Hospitals and Health Systems
  1. Uninsured Settle Pricing Lawsuit With Sutter Health
  2. CMS Issues Final Report Outlining Its Strategic Plan For Specialty Hospitals
• Long Term Care
  1. Sixth Circuit Affirms Civil Money Penalty Imposed On Nursing Home
  2. Nursing Home Care Continues To Fall Short, New Report Finds
• Managed Care
  1. U.S. Court In Maryland Grants Class Certification For Lawsuit Against HMO For Collecting Subrogation Claims
  2. U.S. Court In Michigan Finds HMO Had Rational Basis For Denying Out-Of-Network Provider's Reimbursement Claim
  3. Kaiser Agrees To Pay $5 Million For Lack Of Oversight Of Transplant Facility
• Medicaid
  Group Dismisses Lawsuit Seeking To Enjoin D.C. From Enforcing Medicaid
  Proof-Of-Citizenship Requirements
• Medical Malpractice
  New Jersey Supreme Court Says Psychiatrist Can Be Liable For Abandonment Even Absent Duty To Warn
• News in Brief
  FDA Seeks Comments On UDI System For Medical Devices
• Physicians
  U.S. Court Of Federal Claims Dismisses Physician's Action Against U.S. Stemming From Loss Of Medical Licenses

(c) 2006. Reprinted by permission of AHLA. All rights reserved.

Lawsuit Seeking to Discipline Georgia Physicians for Participation in Executions Dismissed

From the Federation of State Medical Boards:

A lawsuit seeking to require the Georgia Composite State Board of Medical Examiners to punish physicians who participate in executions was dismissed last week by a Fulton County Superior Court judge. Lawyers for seven physicians, including three physicians in Georgia, had sought to have the medical board uphold American Medical Association guidelines that prohibit physicians from involvement in executions.

Lawyers for the state argued that the physicians had no legal standing to sue because they could show no specific harm, and that state law is the determining factor in the administration of lethal injection in Georgia, not the AMA’s ethical guidelines. Complaints were filed with the medical board against a Georgia physician who assisted the department of corrections with executions, but the board declined to discipline him. The lawsuit, filed by a group of Atlanta-area lawyers, unsuccessfully sought to appeal the board’s decision.

In April, Georgia Gov. Sonny Perdue signed a bill (HB 57 [link]) that protects any physician licensed in Georgia from having their license challenged, revoked or suspended if the individual participates, in any way, in the state’s execution process. The Act became effective July 1, 2006, and applies to executions carried out on or after July 1, 2006.

Should prisoners be enrolled in riskier drug studies?

The New York Times has an interesting article on this question, spurred by a recent report of the Institute of Medicine that recommends altering the "minimal risk" standard that now applies to prisoners as long as the greater risks are accompanied by the potential of some benefit to the prisoners themselves. The IOM's press release on the report and recommendations is here.

AHLA Health Lawyers Weekly (04 Aug 2006)

With the permission of the AHLA, here's the TOC for last week's HLW [members only] (which came in while I was on vacation); this week's TOC should be available tomorrow.

• Top Stories
• CMS Issues Final IPPS Rule That Phases-In Move To Cost-Based System
  The Centers for Medicare and Medicaid Services (CMS) issued August 1 the
  much-anticipated inpatient prospective payment system (IPPS) final rule for
  fiscal year (FY) 2007 that seeks to improve the accuracy of hospital payments by moving from a charge to cost-based system and by accounting more fully for patient severity.
• CMS, OIG Release Final Health IT Rules
  The Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services (DHHS) Office of Inspector General (OIG) released final rules August 1 to speed the adoption of electronic prescribing and electronic health records.
• Articles & Analyses
• OIG Publishes Report Of Claims Billed By Independent Diagnostic Testing
  Facilities
  By Marla P. Spindel, Powers, Pyles, Sutter & Verville, P.C.
• 2005-2006 Long Term Care Year In Review
  Compiled by Health Lawyers' Long
  Term Care Practice Group
• 2005-2006 Medical Staff, Credentialing, and Peer Review Year In
  Review
  Compiled by Health Lawyers' Medical Staff, Credentialing, and Peer
  Review Practice Group
• Current Topics
• Corporate Governance
  
  • GAO Releases Survey Results Of Nonprofit
    Hospitals' Executive Compensation Practices
• ERISA
• Eleventh Circuit Upholds Dismissal Of State Law Claims Against Insurer Of ERISA-Governed Health Plan That Failed To Disclose Lapsed Plan
• Food and Drug Law
• FDA Announces Plans For OTC Marketing Of Plan B
• Enzi, Kennedy Introduce Drug Safety Bill
• Fraud and Abuse
• First Circuit Vacates Three-Month Prison Sentence For Executive Convicted Of Conspiring To Defraud Medicare Of Over $5 Million
• Update
• Health Information Technology
• DHHS Recognizes CCHIT Criteria For EHRs, Releases Certification Guidance Document
• Hospitals and Health Systems
• Grassley, Baucus Question Whether CMS' Specialty Hospital Study Is Flawed
• HSC Study Discusses Implications Of Growth In ASCs And Rising Specialty-Service Competition
• Managed Care
• Florida Appeals Court Overturns Dismissal Of Hospital's Action Seeking Reimbursement For Emergency Services Rendered To HMO Subscriber
• Medical Records
• California Appeals Court Finds Health Plan May Disclose To Its Attorney Medical Records Of Potential Malpractice Complainants
• Medicare
• GAO Sees Promise In CMS' New Cost-Based Approach Under IPPS
• CMS Announces First Contract For Payment Of Medicare Part A And B Claims
• Grassley, Baucus Introduce Bill To Improve Accuracy Of Medicare Payments To Hospitals
• OIG Finds Medicare Part B Drug Costs Would Have Been Cut By $16 Million Had CMS Applied Authorized Price Adjustment
• CMS Issues Final Rule Updating Payment Rates For IRFs In FY 2007
• CMS Issues Final Rule On Accreditation Of DME Suppliers
• CBO Researcher Says Medicare Spending Per Beneficiary Has Slowed In Recent Years
• OIG Releases Reports On Medicare Beneficiary Access To Home Health Agencies And Skilled Nursing Facilities
• Report Says Medicare Beneficiaries With HIV/AIDS Face High Out-Of-Pocket Costs Under Part D
• News in Brief
• JCAHO Will Test Measures For Inpatient Psychiatric Services
• NCQA Adds Two New Standards To Its 2007 Accreditation Standards For Managed Care Plans
• Physicians
• New York Court Finds Physician Not Required To Exhaust Administrative Remedies To Sue For Contract Breach
• Quality of Care
• Report Makes Recommendations For Improvement Of Current Flawed Healthcare System

FDA, Barr Pharmaceuticals, reach accord over Plan B contraceptive sales

In Wednesday's paper, the NY Times reports that the FDA and the manufacturer of the Plan B contraceptive have reached an agreement that may lead to OTC sales (at least to customers 18 years of age and up; under-18's will still need a prescription) within weeks. The story doesn't refer to an earlier report that the FDA offered the deal to Barr last week, on the eve of hearings on the nomination of acting Commissioner Andrew C. von Eschenbach, apparently in response to the announced opposition of Sen. Hillary Clinton and other Senate Dems, who had vowed to delay a vote on the nomination until the FDA cleared its apparently unprecedented derailing of the OTC application. Pro-life groups regard the drug as an abortifacient, despite FDA's official classification of Barr's Plan B drug as an emergency contraceptive, so we can expect this latest development to produce the usual ripple effect of abortion politics.

NH's medical board agrees: doc has 1st Amendment right to be a jerk

As reported here earlier, a local NH court ruled that Terry Bennett's rude and crude comments to his patients were protected by the First Amendment and couldn't be the basis of a disciplinary case against the doctor. Apparently the New Hampshire State Board of Medicine agrees. As reported by Modern Healthcare today, the Board

will not appeal a court decision that blocked a disciplinary case over comments made by Rochester, N.H., physician Terry Bennett to patients in his private practice. The board sought to determine whether Bennett's comments, which at least three patients characterized as offensive, breached professional ethics standards.

This has to be the right result, from a constitutional perspective. Too bad it will probably only encourage the good doctor in his boorish and racist comments. The AP story is here (courtesy of the Boston Globe).

Vacation: what a concept (Part Deux)

Now it begins . . . .

AHLA's Health Lawyers Weekly

With AHLA's permission, here's the Table of Contents of today's issue of Health Lawyers Weekly:

I. Top Stories:

• House Clears HIT Legislation
• FDA To Improve Transparency Of Advisory Panel Conflicts, Official Says

II. Articles & Analyses:

• A Discussion About Alternative Dispute Resolution In The Healthcare Field
• 2005-2006 In-House Counsel Year In Review
• 2005-2006 Labor And Employment Year In Review

III. Current Topics:

A. Criminal Law

• Seventh Circuit Says Dentist May Not Withdraw Guilty Plea To Medicaid Fraud

B. Employment and Labor

• New Jersey Supreme Court Says Shareholder-Director Of Radiology Practice Not An "Employee" Under State's Whistleblower Protection Statute

C. ERISA

• U.S. Court In Pennsylvania Says ERISA Pre-Empts Hospital’s Contract Claims Against Insurers

D. Fraud and Abuse

• Update

E. Health Information Technology

• CDC Finds Increasing Percentage Of Office-Based Physicians Using Electronic Medical Records

F. Hospitals and Health Systems

• Oregon Health System Settles Charity Care Lawsuit
• U.S. Court In New Jersey Rejects Lawsuit Against Health System For Overcharging Uninsured
• Labor Union Ordered To Pay $17.3 Million For Defaming Hospital System
• Long Term Care OIG Finds State Survey Agencies Failed To Investigate Serious Complaints At Nursing Homes Within Required Timeframes

G. Managed Care

• California Governor Issues Executive Order To End "Balance Billing"
• Medicaid Sixth Circuit Upholds Dismissal Of Most § 1983 Claims Against Michigan Officials For Failure To Provide Services Mandated By Medicaid Act
• States To Receive $1.75 Billion To Offer Alternative Long Term Care Options Under Medicaid
• CMS Announces New Policies For Medicaid Asset Transfers, Improved Coordination Of Care
• CMS OKs Landmark Massachusetts Healthcare Reform Plan

H. Medical Malpractice

• Texas Appeals Court Finds Error In Dismissal Of Malpractice Action Against Laboratory

I. Medicare

• House Panel Considers Medicare Physician Payment Fixes
• GAO Finds Few Major Access Problems Reported By Medicare Beneficiaries For Physician Services
• CMS Announces Payment Updates For Home Health Services, Nursing Homes

J. News in Brief

• CMS Announces $150 Million In Transformation Grants For State Medicaid Programs
• CMS Issues Final Part D Marketing Guidelines
• CMS Awards Contracts To Test Transfer Of Medicare Data To PHRs For Online Use

K. Physicians

• California Appeals Court Rejects Physician's Retaliatory Eviction And Suspension Claims Against Hospital
• California Supreme Court Holds Hospital Could File Anti-SLAPP Motion To Strike Complaint Arising From Peer Review Proceedings

Vacation: what a concept!

HealthLawBlog will be on vacation for the next two weeks.

With random exceptions, don't expect anything new here before August 10th.

Stay cool. Be happy.

Yates: Not guilty by reason of insanity

Finally . . . .

NOLA murder arrests: further reflections

Today's CDC Public Health Law Newsletter has a link to a Chicago Tribune article that explores the ethics of triage and its applicability vel non to the NOLA cases previously discussed (here, here, and here):

“Disaster plan: Time to think unthinkable?”
Chicago Tribune (07/19/06) Ronald Kotulak

Last week, two nurses and a doctor were arrested in New Orleans on charges that they gave lethal doses of drugs to four hospital patients in the aftermath of Hurricane Katrina. The second-degree murder charges have led ethicists to begin debating what actions taken by medical personnel are permissible in similar situations, such as catastrophic weather events, deployments of weapons of mass destruction, or even widespread influenza epidemics. In such situations, medical care might be limited. “What do you do if you had no way to treat people and they were ill and there was no power and the ventilation had gone down and the machines that had kept them alive were failing? That is an astonishingly important ethical problem, given the realities we face with disaster planning,” said Laurie Zoloth, director of the Center for Bioethics, Science and Society at the Northwestern University Feinberg School of Medicine. Zoloth compared such scenarios to doctors triaging wounded soldiers on the battlefield. Dr. Mark Siegler of the University of Chicago’s MacLain Center for Medical Ethics said there is sometimes a fine line between giving a patient morphine for pain and a dose high enough to cause death. But Dr. Joshua Hauser, a palliative care expert, said doctors have specific guidelines to follow to avoid a morphine-related death. “There’s significant consensus in the medical community that giving a dose of morphine with the intent of ending someone’s life is unacceptable,” he said.

Further thoughts on the Senate abortion bill

As previously noted, the Senate has passed a bill that would impose criminal penalties on anyone who helps a minor travel across state lines from a state that has a parental-notification or -consent law in order to obtain an abortion in a state that has no such restrictions. As the map on my post illustrates, 6 states have no restrictions on minors: Washington, Oregon, Vermont, New York, Massachusetts, and Hawai'i. The House previously passed a similar bill [H.R.748; roll call #144], and news reports today say the president has said he will sign a bill if the two houses of Congress can agree on language in conference [NY Times].

Maybe my brain isn't firing on all 8 cylinders this morning. But -- quite apart from whether you think a restriction like this is good social policy -- when was the last time Congress criminalized two perfectly legal acts, one of which the Supreme Court has decided is Constitutionally protected as a "fundamental right"?

Senate passes prohibition on interstate travel for abortion

The Washington Post has the story. The Senate has passed a a bill (S.403) "to prohibit taking minors across State lines in circumvention of laws requiring the involvement of parents in abortion decisions [preamble]," thus (according to The Post) handing a long-sought victory to the Bush administration and abortion opponents":

The bill would help about three dozen states enforce laws that require minors to notify or obtain the consent of their parents before having an abortion. It would bar people -- including clergy members and grandparents -- from helping a girl cross state lines to avoid parental-involvement laws. Violations could result in a year in prison.

Most states have passed such laws, but courts
have invalidated at least nine of them, advocacy groups say. . . . The Senate voted 65 to 34 to approve the bill, which is similar to one the House has approved before, including last year.

The Senate bill is here and the roll-call vote is here.