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
Wednesday, August 23, 2006
New technique for deriving embryonic stem cells that doesn't destroy the embryo
An on-line letter (1st paragraph only) at the journal Nature (requires subscription) describes the technique, as do articles posted this afternoon to the web sites of the New York Times and the Wall Street Journal (requires subscription). Researchers at Advanced Cell Technology report success borrowing the technique used for pre-implantation genetic diagnosis ("PGD") of embryos created at in vitro fertilization centers. The technique takes the fertilized egg at the point that it is an 8-celled organism. The cells are called blastomeres, and PGD removes one blastomere for genetic testing and screening. Now 10 years old, PGD produces no discernible harm to the remaining 7-cell organism, which appears capable of developing into a normal, health embryo and then fetus. It was reported last year that embryonic stem cells were derived from mouse embryos using this technique. The ACT letter appears to be the first report that the technique can be successfully performed on human embryos. ACT's press release is here. More details are also available from the statement issued by ACT's ethics advisory board.
Despite the head-on challenge this technique represents to current ethical objections to harvesting embryonic stem cells, both papers report that the news was met with different degrees of skepticism, dismay, and downright hostility by the U.S. Conference of Catholic Bishops ("gravely unethical" -- the bishops also oppose IVF and PGD), Glenn McGee ("this will please no one" -- McGee is described as a long-time critic of ACT), and the immediate past chair of the President's Council on Bioethics, Leon Kass ("'I do not think that this is the sought-for, morally unproblematic and practically useful approach we need.' He said the long-term risk of P.G.D. testing is unknown, and that the present stem-cell technique is inefficient, requiring blastomeres from many embryos to generate each new cell line. It would be better to derive human stem cell lines from the body’s mature cells, he said, a method that researchers are still working on.")
Sunday, August 20, 2006
Internet prescribing legislation introduced in U.S. Senate
New legislation designed to regulate the sale of prescription drugs and controlled substances over the Internet was introduced in the U.S. Senate on Aug. 10. The “Online Pharmacy Consumer Protection Act of 2006” (SB 3834)would:
- Prohibit the distribution of controlled substances and prescription drugs via the Internet without a valid prescription issued for a legitimate medical purpose in the usual course of professional practice that is based upon a qualifying medical relationship by a practitioner
- Provide criminal penalties for unlawfully dispensing controlled substances and prescription drugs over the Internet
- Give state attorneys general a civil cause of action against violators
- Allow the federal government to take possession of property used illegally by online pharmacies
- Require online pharmacies to file an additional registration statement with the attorney general and meet additional registration requirements
- Report to the attorney general all controlled substances and prescription drugs dispensed over the Internet
Saturday, August 19, 2006
Latest from AHLA's Health Lawyers Weekly (18 Aug 2006)
(c) 2006. Reprinted by permission of AHLA.Top Stories
- CMS Issues Final Quality Standards For DMEPOS Suppliers
The Centers for Medicare and Medicaid Services (CMS) released August 14 its final quality standards for suppliers of durable medical equipment, prosthetics, orthotics, supplies, (DMEPOS) and other items and services under the Medicare program. The standards have been scaled-back substantially from the draft version issued in September 2005, thereby reducing the standards document from 104 pages to fourteen pages. Full Story- OIG Finds Some MA Marketing Materials Not In Compliance With CMS Requirements
Some Medicare Advantage (MA) marketing materials for 2005 did not meet the Centers for Medicare and Medicaid Services' (CMS') requirements for marketing, the Department of Health and Human Services Office of Inspector General (OIG) found in a report issued August 14. Full StoryArticles & Analyses
- Impact Of Proposed Changes To The Medicare Physician Fee Schedule On Diagnostic Imaging Providers
By Thomas W. Greeson and Heather M. Zimmerman, Reed Smith LLP, Falls Church, VA- 2005-2006 Tax And Finance Year In Review
Compiled by Health Lawyers' Tax and Finance Practice GroupCurrent Topics
- AIDS
New Jersey Appeals Court Finds Hospital That Failed To Notify Patient Of Positive HIV Test Results Civilly Liable To Patient's Sexual- Employment and Labor
1. North Carolina Appeals Court Finds Covenant Not To Compete Valid
2. Missouri Supreme Court Finds Home Healthcare Provider's Noncompetition Agreements Are Valid And Enforceable- ERISA
U.S. Court In Ohio Finds ERISA Does Not Preempt Hospital's State Law Claims Against Plan Administrator- Food and Drug Law
1. OIG Report Finds Deficiencies In FDA's National Drug Code Directory
2. FDA Issues Warning Letters To Three Pharmacies Engaged In Compounding Mass Amounts Of Inhalation Drugs- Fraud and Abuse
1. Louisiana Hospital Agrees To Pay U.S. $3.8 Million To Settle Fraud Allegations
2. Update- Health Policy
Many Americans Report Unsafe Or Wasteful Healthcare, New Survey Finds- Healthcare Access
Study Finds Fewer Physicians Accepting New Medicaid Patients- Medicaid
1. Nebraska Supreme Court Finds Longer Look-Back Period Applied To Medicaid Eligibility Decision Was Error
2. House Members Urge CMS To Change Medicaid Citizenship Requirements- Medical Malpractice
1. Connecticut Appeals Court Finds Patient's Medical Malpractice Action Against Radiologist Time-Barred
2. Louisiana Appeals Court Finds Lack Of Notation In Medical Record Created Material Issue Regarding Whether Treatment Recommendation Was Made To Patient- Medical Records
Mississippi Supreme Court Finds Health Insurer Did Not Owe Fiduciary Duty To Maintain Confidentiality Of Insured's Medical Records- Medicare
Part D Costs For 2007 Lower Than Predicted, CMS Says- Physicians
Iowa Appeals Court Finds Evidence Supports Medical Board's Disciplinary Action- Quality of Care
NCQA Seeking Input On Implementation Of Single Set Of Standards For All Health Plans
Friday, August 18, 2006
It's a good time to be in cardiology
- 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.
Wednesday, August 16, 2006
Medical liability insurers profiting handsomely in wake of Texas tort reform
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."
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