Health care law (including regulatory and compliance issues, public health law, medical ethics, and life sciences), with digressions into constitutional law, statutory interpretation, poetry, and other things that matter
Tuesday, August 15, 2006
More on emergency room practices
ER sends nonemergency patients packing
Sunday, August 13, 2006
Kaiser fined for mismanagement of its kidney-transplant program
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
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
Latest from AHLA's Health Lawyers Weekly (11 Aug 2006)
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
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?
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
- GAO Releases Survey Results Of Nonprofit
- 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
Thursday, August 03, 2006
NH's medical board agrees: doc has 1st Amendment right to be a jerk
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).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.
Friday, July 28, 2006
AHLA's 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!
Wednesday, July 26, 2006
NOLA murder arrests: further reflections
“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
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 Senate bill is here and the roll-call vote is here.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.
Juvenile court orders teen to accept chemo, reversed by circuit court
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:
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
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."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."