Sunday, August 13, 2006

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

Articles & Analyses

Current Topics

(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.

Thursday, August 10, 2006

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

Tuesday, August 08, 2006

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.

Thursday, August 03, 2006

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).

Friday, July 28, 2006

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

Thursday, July 27, 2006

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.

Wednesday, July 26, 2006

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"?

Tuesday, July 25, 2006

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.

Juvenile court orders teen to accept chemo, reversed by circuit court

Starchild Abraham Cherrix has Hodgkin's disease, and when the disease returned after his initial round of chemo, he refused a second round, opting instead for "a sugar-free, organic diet and take herbal supplements under the supervision of a clinic in Mexico" [Washington Post]:

A social worker asked a juvenile court judge to require the teen to continue conventional treatment, and the judge on Friday ordered Abraham to report to a hospital Tuesday. But Accomack County Circuit Court Judge Glen A. Tyler suspended the judge's order. . . . Tyler [also] agreed to a stay and set a trial date of Aug. 16 [and] ended joint custody of Abraham between his parents and social services officials.

In a similar case last year, the parents of 13-year-old Hodgkin's disease patient Katie Wernecke won the right in November to make all her medical decisions after a court fight with Texas child welfare officials. Doctors had recommended chemotherapy and radiation; her father favored a program of intravenous vitamin C.

The 'Net is ablaze with coverage of this story, as well as commentary. Here is a sampling:

  • Treatment should be patients' choiceMSU State News, MI - 52 minutes ago... illnesses? Starchild Abraham Cherrix, who goes by Abraham, a 16-year-old from Virginia, has been dealing with this question lately....
  • Is That Freedom Ringing?Hammer of Truth - 1 hour agoGood news from the Abraham Cherrix saga! Accomack County Circuit Court Judge Glen A. Tyler ruled that Abraham does not have to report ...
  • Statements on Abraham Cherrix chemotherapy court decision by Mike ...Newstarget.com, Taiwan - Jul 21, 2006"The court's demand that Abraham Cherrix, a clear-thinking young man ... It is the ultimate misuse of power and equivalent to a death sentence upon Mr. Cherrix.". ...
  • His say-so was boycottedWashington Times, DC - 12 minutes ago... On July 21, juvenile court Judge Jesse E. Demps ruled that the boy's parents, Jay and Rose Cherrix of Chincoteague, were neglectful and must continue to share ...
  • Teen's court battle gains national attentionChincoteague Beacon, VA - Jul 20, 2006... it probes at what age a minor is old enough to make personal medical choices -- is drawing remarkable media attention for 16-year-old Abraham Cherrix and his ...

Art Caplan is one of the few voices in the wilderness who questions the wisdom of letting young Mr. Cherrix decide his fate:

  • Medical Neglect? The Abraham Cherrix Case
    This is an especially tough case since the child involved is older and seems very mature. Still it is hard to deny an efficacious treatment based on the views of a sixteen year old who is still strongly under his parents influence when it comes to attitudes about standard medical care.

Monday, July 24, 2006

The American Way of Death IV

While we're talking about patient and family perceptions of end-of-life care in the hospital -- we were talking about that, weren't we? just yesterday? -- Pamela Winnick's essay in the Wall Street Journal on July 21 is well worth considering. She talks about a resident nicknamed "Dr. Death" who pursues family members down the hall to harangue them about her father's alleged desire to be allowed to die a dignified death. She continues:

"Dr. Death" was just one of several. A new resident appeared the next day, this one a bit more diplomatic but again urging us to allow my father to "die with dignity." And the next day came yet another, who opened with the words, "We're getting mixed messages from your family," before I shut him up. I've written extensively about practice of bioethics -- which, for the most part, I do not find especially ethical -- but never did I dream that our moral compass had gone this far askew. My father, 85, was heading ineluctably toward death. Though unconscious, his brain, as far as anyone could tell, had not been touched by either the cancer or the blood clot. He was not in a persistent vegetative state" (itself a phrase subject to broad interpretation), that magic point at which family members are required to pull the plug -- or risk the accusation that they are right-wing Christians.

I complained about all the death-with-dignity pressure to my father's doctor, an Orthodox Jew, who said that his religion forbids the termination of care but that he would be perfectly willing to "look the other way" if we wanted my father to die. We didn't. Then a light bulb went off in my head. We could devise a strategy to fend off the death-happy residents: We would tell them we were Orthodox Jews.

"My little ruse," she reports, "worked. During the few days after I announced this faux fact, it was as though an invisible fence had been drawn around my mother, my sister and me. No one dared mutter that hateful phrase 'death with dignity.'" Eventually her father was well enough to be transferred out of the ICU and then out of the long-term respiratory care unit. "A day later he was off the respirator, able to breathe on his own. He still mostly slept, but then he began to awaken for minutes at a time, at first groggy, but soon he was as alert (and funny) as ever. A day later, we walked in to find him sitting upright in a chair, reading the New York Times."

This a good reminder for all of us who work with ethics committees and through them with the families of (apparently) dying patients: The "death with dignity" mantra needs to be applied cautiously, patiently, and with sensitivity and a healthy dose of humility.

The HCA deal is done

The closing probably won't be till the 4th quarter, assuming the federal regulators bless it and the board doesn't get a better offer, but HCA's board has approved the sale of the company to an aglomeration of investment bankers and the founding Frist family. Of course, no one can quite agree whether the deal is worth $21 billion, $31 billion, or $33 billion, but what's a few billion here or there?
  • HCA Agrees to $21.3B Leveraged Buyout Washington Post, United States - By Daniela Deane. HCA Inc., the country's largest for-profit hospital operator group founded by the family of Senate Majority Leader ...
  • HCA Goes For The Record Forbes - HCA, the huge for-profit hospital operator, agreed on Monday to be taken private by a consortium that will pay $33 billion in cash and assumed debt, the ...
  • US hospital operator faces $41b private equity buyout Sydney Morning Herald, Australia - THREE private equity firms will offer to buy America's biggest hospital operator, HCA, for about $US31 billion ($41 billion) including debt, people familiar ...

The biggest disparity in the reported figures is probably attributable to the $10.6 billion of debt that's being assumed. Once the reporting settles on the value of the deal, it will be in the $31-33 billion range. As Forbes is reporting, their estimate of $31.6 billion would make this the largest leveraged buyout in U.S. history, exceeding KKR's $31.1 billion purchase of RJR Nabisco in 1989. (KKR is also involved in the HCA deal.)

From a health policy perspective, I expect the pundits to ask the question whether for-profit health care ought to be so profitable that it would lead savvy business people to shell out this kind of money. Forbes' title for one of its on-line stories this morning unintentionally sums it up nicely: "Health Is Wealth." When a health care provider can throw of this amount of wealth for private investors, it's bound to fuel questions about whether patients and payers, including the federal government, are paying too much for what they receive.

The investors are also giving us their take on the long-term future of health care in this country. From Forbes: "Apart from betting that economic conditions in the U.S. will remain stable, the suitors will be hoping that the aging American population continues to prompt higher spending on health care, and that the government eventually resolves the problem of uninsured patients."

Sunday, July 23, 2006

HCA close to $21 billion buyout

After coming oh so close to closing a deal last weekend, it looks like the board is on the verge of approving a $21 billion deal tonight. As reported by the NY Times, "HCA, the nation’s largest for-profit hospital operator, was close to a deal last night to sell itself to a consortium of private equity investors for about $21 billion, people involved in the talks said. The investors would also take on about $10.6 billion of HCA’s debt, making the deal the largest leveraged buyout in history." For-profit healthcare is looking rosy (or, at a minimum, HCA insiders and some savvy investment bankers think HCA's stock is 'way undervalued by the market).

Criminal Law III: More on the NOLA murder prosecutions

AP/Yahoo has an article today entitled, "Many see accused New Orleans MD as hero." State AG made much of the fact that both morphine and Versed were found in the the bodies of the four patients whose deaths were the basis for his order to arrest Dr. Pou and the two nurses. Contrary to his assertion that the two drugs together can mean only one thing -- that the health care workers' intent was to produce the patients' death -- "Dr. Daniel Nuss (Dr. Pou's department head at LSU) and other doctors said the morphine and Versed that investigators found in the patients' bodies are commonly given to relieve suffering and anxiety. 'If you didn't find sedatives and analgesics in these people, I would think that was inhumane,' [Dr. Ben] deBoisblanc[, director of critical care at Charity Hospital] said. 'The very fact that you found these drugs means nothing.'"

The American Way of Death III

NPR's Studio 360 program has a wonderful item this week on Emily Dickinson and her iconic poem, "Because I Could Not Stop For Death." The program is available as an MP3 file here.

We read this poem every year in Law, Literature & Medicine, where third-year law students from SMU and fourth-year medical students from UT-Southwestern wrestle with Dickinson's verses, among many others.


Because I could not stop for Death –
He kindly stopped for me –
The Carriage held but just Ourselves –
And Immortality.

We slowly drove – He knew no haste
And I had put away
My labor and my leisure too,
For His Civility –

We passed the School, where Children strove
At Recess – in the Ring –
We passed the Fields of Gazing Grain –
We passed the Setting Sun –

Or rather – He passed us –
The Dews drew quivering and chill –
For only Gossamer, my Gown –
My Tippet – only Tulle –

We paused before a House that seemed
A Swelling of the Ground –
The Roof was scarcely visible –
The Cornice – in the Ground –

Since then – 'tis Centuries – and yet
Feels shorter than the Day
I first surmised the Horses' Heads
Were toward Eternity –

courtesy of the Academy of American Poets

The American Way of Death II

Thanks to Joe Paduda's "Managed Care Matters" for pointing me to this story in the Minneapolis-St. Paul Business Journal about a recent article in Mayo Clinic Proceedings: "Adult Intensive Care Unit Use at the End of Life: A Population-Based Study," by Seferian and Afessa [abstract; full text available in 6 months]. As reported in the business journal:

Intensive care costs comprise 30 to 40 percent of hospital spending and may continue to grow as the population ages, according to a new Mayo Clinic study. Older people with chronic illnesses have the highest rates of intensive-care-unit (ICU) use at the end of their lives, the study found. The country's aging population has an increased prevalence of chronic diseases, signaling that ICUs may treat more and more people in the years ahead. . . .

The study was set in Olmsted County, home of Rochester-based Mayo Clinic, and looked at 818 residents who were admitted to an ICU in 1998. Of those people, one in five died after having received ICU care in the last six months of life. Patients in the last year of their lives accounted for one-fourth of the ICU days used by county residents.

As Paduda points out, these numbers are consistent with a study led by Dartmouth's John Wennberg. As summarized by NewsTarget.com:
The Dartmouth Atlas Project studied the records of 4.7 million Medicare enrollees who died from 2000 to 2003 and had at least one of 12 chronic illnesses. The study demonstrates that even within this limited patient population, Medicare could have realized substantia savings — $40 billion or nearly one-third of what it spent for their care over the four years — if all U.S. hospitals practiced at the high-quality/low-cost standard set by the Salt Lake City region.