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, October 18, 2006
If it could happen to Triad, it could happen to you
Tuesday, October 17, 2006
Latest from AHLA's Health Lawyers Weekly (13 Oct 2006)
Top Stories
- CMS Reduces Improper Claims By $1.3 Billion
Improper Medicare claims payments were reduced $1.3 billion between 2005 and 2006, the Centers for Medicare and Medicaid Services (CMS) said October 12.The Medicare fee-for-service (FFS) error rate has declined from 14.2% in 1996 when the improper payment rate was first reported, to 5.2% in 2005, to the current 4.4% in 2006, CMS said in a press release. Full Story- OIG Finds DME Manufacturer's Proposal To Offer Suppliers Free Advertising Problematic
A proposed arrangement in which a durable medical equipment (DME) manufacturer would provide free advertising and reimbursement consulting services to some of its DME supplier customers could generate prohibited remuneration under the Anti-Kickback Statute and potentially trigger administrative sanctions, according an advisory opinion posted October 10 by the Department of Health and Human Services Office of Inspector General (OIG). Full StoryArticles & Analyses
- FDA Updates Compliance Program For Inspecting Medical Device Manufacturers, by Edward M. Basile and Mark S. Brown, King
& Spalding LLPCurrent Topics
- Food and Drug Law
Settlement Between Publisher Of Prescription Drug Prices And Consumer Advocacy Group Calls For Ceasing Publication Of AWP Drug Pricing Data- Fraud and Abuse
1. U.S. Court In California Finds FCA Public Disclosure Bar Requires Dismissal Of Qui Tam Complaint
2. OIG Approves Company's Agreement To Act As Pay-For-Performance Payment Administrator For State Medicaid Agency
3. Update- Health Information Technology
1. U.S. Court In District Of Columbia Finds Association Lacks Standing To Sue DHHS Over Creation Of IT Advisory Committee
2. Standard Definition Of EHR Key To Establishing Reliable Benchmarks Of Use, Report Says- Healthcare Spending
Estimates Show Employers' Average Healthcare Costs To Increase 7.7% In 2007- Hospitals and Health Systems
Montana High Court Allows New License For Specialty Hospital That Changed Its Status To General Hospital- Medicaid
1. OIG Finds Most Surveyed States Did Not Routinely Verify DME Providers Met Medicaid Enrollment Standards
2. Medicaid Spending Growth Slows To Lowest Point In Ten Years- Medical Malpractice
Florida Appeals Court Allows Medical Malpractice Lawsuit Against Hospital Based On Independent Contractor Physician's Alleged Negligence- Medicare
1. CMS Should Change Method Of Allocating MIP Funds, GAO Finds
2. U.S. Court In Texas Finds Medicare Contractor Failed To Exhaust Administrative Remedies
3. U.S. Court In Pennsylvania Finds Nonprofit Hospital Merger Was Not A Related-Party Transaction
4. State Medicaid Directors Urge CMS To Revisit Calculation Of State Part D Payments- News in Brief
CMS Says Fraud Fighting Efforts Save Billions- Physicians
1. U.S. Court In West Virginia Says Hospital Entitled To HCQIA Immunity From Physicians' Claims
2. U.S. Court In New York Dismisses Physician's HCQIA And RICO Claims Against Hospital That Terminated His Privileges- PRRB
1. PRRB Hearing Decisions Recap
2. CMS Administrator Decisions Recap
3. Jurisdictional Determinations Recap- Tax
1. Study Provides Nonprofit Hospitals Strategies For Measuring, Reporting Community Benefit
2. CHA Releases New Community Benefit Resource
3. Articles & Analyses
Copyright 2006 American Health Lawyers Association. Printed with permission.
Monday, October 16, 2006
"The Massachusetts Plan and the Future of Universal Coverage"
AHLA, Matyas & Valiant score with new edition of fraud and abuse classic
The third edition has just been published, and I'm happy to report that it is a worthy successor to the first two editions. For a book that comes in at just under 500 pages, it is surprisingly comprehensive. It also doesn't scrimp on historical background and policy analysis and includes a useful chapter on the ethical and legal aspects of representing healthcare organizations in fraud and abuse matters.
Strong "buy" recommendation.
Sunday, October 15, 2006
Back to the world of the living
Wednesday, October 11, 2006
Falling into Medicare Part D's doughnut hole
1. For some beneficiaries, the effect of the doughnut hole -- which leaves seniors paying 100% of their drug costs between $2250 and $5100 -- will be higher out-of-pocket costs after Part D became effective than before. For some, perhaps many or even most, Medicare beneficiaries -- including those whose drug use doesn't push them into the doughnut hole, as well as those whose utilization is at truly catastrophic levels, where Plan D kicks back in and covers 95% of drug costs -- Part D will be a boon. But it's promise is false for many who fall into the doughnut hole and aren't "lucky" enough to have catastrophic levels of drug needs.
2. The Times says Medigap coverage can be purchased to insure the doughnut hole. That's only true, I believe, if the beneficiary's drug plan offers supplemental coverage, and many don't. In many other cases, seniors who were unaware of the implications of the doughnut hole chose a drug plan that didn't offer supplemental coverage and was therefore cheaper than another plan that did offer the supplemental coverage at a somewhat higher price. This is confusing for young, healthy law students in my health law class; imagine what confusion was out in the land when seniors were sorting and evaluating their options earlier this year.
Saturday, October 07, 2006
Rationing flu vaccine: WSJ considers the ethics
You have 100 doses of a vaccine against a deadly strain of influenza that is sweeping the country, with no prospect of obtaining more. Standing in line are 100 schoolchildren and 100 elderly people.
The elderly are more likely to die if they catch the flu. But they also have fewer years left to live and don't get out enough to easily spread or catch the disease. The kids are more likely to act like little Typhoid Marys, sneezing virus over anyone they encounter, and have almost their whole life ahead of them. But they're also less likely to die if they get sick.
Whom do you vaccinate?
This dilemma is haunting experts concerned that avian influenza might start spreading from person to person instead of (as far as we know) mainly from birds to people. But it also applies to regular old flu, which always has the potential to reach pandemic proportions. In response, studies now are shedding light on the ethical issues and the most effective strategy for reducing illness and death if vaccine must be rationed. Sadly, they make a pretty good case that current U.S. policies leave a lot to be desired.
Friday, October 06, 2006
Latest from AHLA's Health Lawyers Weekly (06 Oct 2006)
Top Stories
- Illinois Department Of Revenue Denies Nonprofit Hospital's Property Tax Exemption Renewal -- The nonprofit hospital, Provena Covenant Medical Center (Provena), does not qualify for the charitable institution tax exemption provided for under Illinois' property tax statutes because the hospital failed to provide sufficient evidence clearly demonstrating that it has met the statutory requirement to use its property primarily for charitable purposes, according to a final administrative decision issued September 29 by the Illinois Department of Revenue (IDOR). Full Story
- GAO Finds Weaknesses In CMS' Information Security Leave Sensitive Information Vulnerable -- Significant weaknesses in the Centers for Medicare and Medicaid Service's (CMS') electronic access and other system controls threaten the confidentiality and availability of sensitive financial and medical information, the Government Accountability Office (GAO) found in a new report. Full Story
Articles & Analyses
- The National Labor Relations Board Finally Provides Guidance On "Supervisors" Under The National Labor Relations Act: By John E. Lyncheski and Floyd A. Clutter, Cohen & Grigsby P.C.
Current Topics
- Food and Drug Law
1. President Signs Homeland Security Spending Bill With Drug Importation Provision
2. Lawmakers Introduce Legislation To Spur Approval Of Biogenerics- Fraud and Abuse
1. OIG, DOJ Release Annual Tally Of Anti-Fraud Efforts
2. Update
3. South Carolina Supreme Court Upholds State Statute Prohibiting Physician-Owned Physical Therapy Services Arrangements
4. Omnicare To Pay $52.5 Million To Settle Medicaid Fraud Allegations In Michigan- Healthcare Access
California Governor Signs Legislation Directed At Making Drugs More Affordable For Low-Income And Uninsured- Healthcare Spending
Study Finds Steady Growth In Health Spending- Legal Representation
Florida Supreme Court Adopts Rule Allowing Medical Malpractice Claimants To Waive Their State Constitutional Right To Caps On Attorneys' Fees- Long Term Care
New Hampshire Supreme Court Finds Nursing Home Reimbursement Changes Invalid- Medicaid
1. CMS Announces Final DSH Allotment Amounts
2. Tenth Circuit Finds Medicaid Statute Does Not Require States To Provide Certain Services To Developmentally Disabled
3. DHHS Approves Funding For New York Healthcare Reform Initiative
4. CMS Should Increase Financial Oversight Of Medicaid Program, Report Says- Medical Malpractice
Louisiana Appeals Court Finds Malpractice Damages Cap Unconstitutional- Medicare
1. U.S. Court In District Of Columbia Says DRA Retroactively Changed DSH Formula To Exclude Expansion Populations From Earlier Calculation
2. CMS Posts Medicare's 2007 Drug Plan Options
3. CMS Revises Wage Index For IPPS Rates
4. CMS Says Majority Of Eligible U.S. Hospitals Satisfied FY 2007 Requirements For Voluntary Quality Reporting
5. Appeals Court Grants Stay Of Order Enjoining CMS From Collecting Medicare Part D Premiums Mistakenly Refunded
6. U.S. Court In Connecticut Dismisses Class Action Challenging DHHS' Denial of Medicare Coverage For Post-Hospital SNF Stays- Physicians
U.S. Court In Kansas Rejects Physician's Discrimination, Antitrust Claims Against Hospital Following Denial Of Medical Staff Reappointment- Supreme Court
1. Supreme Court Declines Review Of Third Circuit Ruling Rejecting Challenge To HIPAA Privacy Rule's "Routine Use" Exception
2. Supreme Court Declines Review Of Rulings That Physicians' Antitrust Claims Against HMOs Not Subject To Arbitration
3. Supreme Court Declines Review Eleventh Circuit Finding That Former Sales Employee Failed To Plead Fraud With Particularity
4. Supreme Court Declines Review Of Eighth Circuit Decision Dismissing FCA Claim For Lack Of Specificity
5. Supreme Court Leaves Standing Sixth Circuit Ruling That Qui Tam Plaintiff Failed To Plead Fraud With Particularity(c) 2006 AHLA. Reprinted with permission
Wednesday, October 04, 2006
GAO: CMS' medical data susceptible to hackers
Here are a few opening paragraphs that ought to startle even the most jaded government bureaucrat:
There is more here: AP/MyWay. The GAO report is here (pdf).Security weaknesses have left millions of elderly, disabled and poor Americans vulnerable to unauthorized disclosure of their medical and personal records, federal investigators said Tuesday.
The Government Accountability Office said it discovered 47 weaknesses in the computer system used by the Centers for Medicare and Medicaid Services to send and receive bills and to communicate with health care providers.
The agency oversees health care programs that benefit one in every four Americans. Its massive amount of data is transmitted through a computer network that is privately owned and operated.
However, CMS did not always ensure that its contractor followed the agency's security policies and standards, according to the GAO report released Tuesday.
"As a result, sensitive, personally identifiable medical data traversing this network are vulnerable to unauthorized disclosure," the federal investigators said. "And these weaknesses could lead to disruptions in CMS operations."
Oh, and back to the government bureaucrat who should be at least a little alarmed that there are 47 access points for hackers to gain access to the medical records of 1 out of 4 Americans. CMS administrator Mark McClellan -- who, with a Ph.D. in economics and an M.D., presumably knows when he is commenting on the story he wished he had read rather than the story that he was actually reading -- commented that the GAO "found no evidence that confidential or sensitive information had actually been compromised."
SSRN roundup: public health law (September 2006 additions)
- Governance, Microgovernance and Health - Temple Law Review, Vol. 77, p. 335, 2004
Scott Burris, Temple University Beasley School of Law
Date Posted: September 27, 2006
Last Revised:September 27, 2006
Accepted Paper Series
3 downloads - Regulatory Paradox in the Protection of Human Research Subjects: A Review of OHRP Enforcement Letters - Northwestern University Law Review, Vol. 101, No. 2, 2007, Temple University Legal Studies Research Paper
Scott Burris and Jen Welsh, Temple University Beasley School of Law and Conrad O'Brien Gellman & Rohn, P.C.
Date Posted: September 27, 2006
Last Revised: September 27, 2006
Accepted Paper Series
4 downloads - U.S. Health Researchers Review Their Ethics Review Boards: A Qualitative Study -
Journal of Empirical Research on Human Research Ethics, Vol. 1, No. 2, pp. 39-58, 2006
Scott Burris and Kathryn Moss,Temple University Beasley School of Law and University of North Carolina at Chapel Hill - Cecil G. Sheps Center for Health Services Research
Date Posted: September 27, 2006
Last Revised: September 27, 2006
Accepted Paper Series
2 downloads - Between Charity, Welfare, and Warfare: A Disability Legal Studies Analysis of Privilege and Neglect in Israeli Disability Policy - Yale Journal of Law and the Humanities, Vol. 18, No. 2, Forthcoming
Sagit Mor, University of Haifa - Faculty of Law
Date Posted: September 15, 2006
Last Revised: September 15, 2006
Accepted Paper Series
6 downloads - Oy Canada! Trade's Non-Solution to 'the Problem' of U.S. Drug Prices - U of Maryland Legal Studies Research Paper No. 2006-31, American Journal of Law & Medicine, Vol. 32, pp. 247-277, 2006
Daniel J. Gilman, University of Maryland - School of Law
Date Posted: September 13, 2006
Last Revised: September 26, 2006
Accepted Paper Series
11 downloads - Why Understanding Smoking Bans is Important for Estimating their Effects: California's Restaurant Smoking Bans and Restaurant Sales
Robert K. Fleck and F. Andrew Hanssen, Montana State University - Bozeman - Department of Agricultural Economics and Economics and Montana State University - Bozeman - Department of Agricultural Economics and Economics
Date Posted: September 13, 2006
Last Revised: September 23, 2006
Working Paper Series
10 downloads - Gasping for Breath: The Administrative Flaws of the Federal Hazardous Air Pollutant Program - U of Houston Law Center No. 2006-W-01
Victor Byers Flatt, University of Houston Law Center
Date Posted: September 11, 2006
Last Revised: September 27, 2006
Working Paper Series
6 downloads - Private Regulation of Food Safety by Supermarkets - Law & Policy, Vol. 28, Issue 4, pp. 515-533, October 2006
Tetty Havinga, Affiliation Unknown
Date Posted: September 8, 2006
Last Revised: September 8, 2006
Accepted Paper Series - Abortion, Equality, and Administrative Regulation - Columbia Public Law Research Paper No. 06-118, Emory Law Journal, Vol. 56, 2007
Gillian E. Metzger, Columbia University - Columbia Law School
Date Posted: September 8, 2006
Last Revised: September 8, 2006
Accepted Paper Series - Is Public Health Paternalism Really Never Justified? A Response to Joel Feinberg - Oklahoma City University Law Review, Vol. 30, pp. 121-207, 2005
Thaddeus Mason Pope, University of Memphis - Cecil C. Humphreys School of Law
Date Posted: September 8, 2006
Last Revised: September 8, 2006
Accepted Paper Series - Underage Drinking: Does Current Policy Make Sense? - Marquette Law School Legal Studies Paper No. 06-35, Lewis & Clark Law Review, Vol. 10, 2006
Judi McMullen, Marquette University - Law School
Date Posted: September 6, 2006
Last Revised: September 6, 2006
Accepted Paper Series
11 downloads - It Might Have Been: Risk, Precaution, and Opportunity Costs - Cornell Legal Studies Research Paper No. 06-023
Douglas A. Kysar, Cornell University - School of Law
Date Posted: September 5, 2006
Last Revised: September 5, 2006
Working Paper Series
77 downloads - Smoking and Externalities Regulation: Why Legislative Action has Gone too Far
Tim Kowal, Chapman University - School of Law
Date Posted: September 1, 2006
Last Revised: September 10, 2006
Working Paper Series
1 downloads
Tuesday, October 03, 2006
NLRB rules most charge nurses are "supervisors"
The National Labor Relations Board ruled that certain full-time hospital charge nurses are supervisors and therefore ineligible to join unions in a case involving Oakwood Healthcare, Dearborn, Mich., and the United Auto Workers. The long-awaited decision creates a "broad new standard" for union membership, labor leaders said. The "immediate implications" of the case are "devastating to workers in the healthcare industry and potentially in other industries where professional employees direct or assign the work of others," AFL-CIO [link] President John Sweeney said in a statement [link].
The case is Oakwood Healthcare, Inc., No. 7–RC–22141 (pdf). It reverses a 2002 decision by the Acting Regional Director to include charge nurses in the bargaining unit, principally on the basis of the Supreme Court's decision in NLRB v. Kentucky River Community Care, 532 U.S. 706 (2001). In Kentucky River, another nurse-supervisor case, the Court rejected the Board's categorical exclusion from supervisor status of employees who exercise “ordinary professional or technical judgment in directing less-skilled employees to deliver services in accordance with employer-specified standards.” (This was the second time in a decade that the Court had spanked the NLRB for its analysis in a nurse-supervisor case. See NLRB v. Healthcare & Retirement Corp. of America, 511 U.S. 571, 579 (1994) (holding 5-4 that the Board erred in finding a nurse’s supervisory activity that was incidental to patient care was not exercised “in the interest of the employer”).)
Left to figure out what its standard should be after Kentucky River, the Board states: "exercising our discretion to interpret ambiguous language in the Act, and consistent with the Supreme Court’s instructions in Kentucky River, we herein adopt definitions for the terms 'assign,' 'responsibly to direct,' and 'independent judgment' as those terms are used in Section 2(11) of the Act. In a key paragraph, the Board writes:
Consistent with the Court’s Kentucky River decision, we adopt an interpretation of the term “independent judgment” that applies irrespective of the Section 2(11) supervisory function implicated, and without regard to whether the judgment is exercised using professional or technical expertise. In short, professional or technical judgments involving the use of independent judgment are supervisory if they involve one of the 12 supervisory functions of Section 2(11). Thus, for example, a registered nurse who makes the “professional judgment” that a catheter needs to be changed may be performing a supervisory function when he/she responsibly directs a nursing assistant in the performance of that work. Whether the registered nurse is a 2(11) supervisor will depend on whether his or her responsible direction is performed with the degree of discretion required to reflect independent judgment.Webster's Third place a large role in the Board's analysis, which leads the Board to complain, somewhat defensively, "In interpreting those statutory terms, we do not, as the dissent maintains, blindly adopt 'dictionary-driven' definitions. Rather, we begin our analysis with a first principle of statutory interpretation that 'in all cases involving statutory construction, our starting point must be the language employed in Congress. . . . '"
Much is at stake in these cases involving professionals in the workplace, cases in which the Board is struggling to extend the scope of the NLRA -- a remedial statute -- but not beyond the limits of Congressional intent. As the dissenters point out:
Today’s decision threatens to create a new class of workers under Federal labor law: workers who have neither the genuine prerogatives of management, nor the statutory rights of ordinary employees. Into that category may fall most professionals (among many other workers), who by 2012 could number almost 34 million, accounting for 23.3 percent of the work force. “[M]ost professionals have some supervisory responsibilities in the sense of directing another’s work—the lawyer his secretary, the teacher his teacher’s aide, the doctor his nurses, the registered nurse her nurse’s aide, and so on" [quoting from NLRB v. Res-Care, Inc., 705 F.2d 1461, 1465 (7th Cir. 1983) (opinion by Circuit Judge Posner)].
In the view of the dissenting Board members, the Board has failed yet again:
If the National Labor Relations Act required this result — if Congress intended to define supervisors in a way that swept in large numbers of professionals and other workers without true managerial prerogatives—then the Board would be dutybound to apply the statute that way. But that is not the case. The language of the Act, its structure, and its legislative history all point to significantly narrower interpretations of the ambiguous statutory terms “assign . . . other employees” and “responsibly to direct them” than the majority adopts. The majority rejects what it calls a “results-oriented approach” in interpreting the Act. But the reasonableness of the majority’s interpretation can surely be tested by its real-world consequences. Congress cared about the precise scope of the Act’s definition of “supervisor,” and so should the Board. Instead, the majority’s decision reflects an unfortunate failure to engage in the sort of reasoned decision-making that Congress expected from the Board, which has the “primary responsibility for developing and applying national labor policy.” NLRB v. Curtin Matheson Scientific, Inc., 494 U.S. 775, 786 (1990).
SSRN roundup: health law (September 2006 additions)
- Consolidating Pharmaceutical Regulation Down Under: Policy Options and Practical Realities - Boston Univ. School of Law Working Paper No. 06-36, University of Queensland Law Journal, Vol. 26, No. 1, p. 111, 2006
Frances H. Miller, Boston University School of Law
Date Posted: September 26, 2006
Last Revised:September 26, 2006
Accepted Paper Series
6 downloads - Navigating the Social Safety Net: A State-Level Analysis of the Relationships Between Medicaid, the Uninsured and Consumer Bankruptcy
Amy K. Yarbrough and Robert J. Landry III, College of Public Health and Health Professions, University of Florida and College of Commerce and Business Administration, Jacksonville State University
Date Posted: September 26, 2006
Last Revised:September 26, 2006
Working Paper Series
2 downloads - Doctors & Juries - U of Missouri-Columbia School of Law Legal Studies Research Paper No. 2006-33
Philip G. Peters Jr., University of Missouri at Columbia - School of Law
Date Posted: September 20, 2006
Last Revised: September 27, 2006
Working Paper Series
39 downloads - Federalism, Federal Regulation, or Free Market? An Examination of Mandated Health Benefit Reform - U of Missouri-Columbia School of Law Legal Studies Research Paper No. 2006-32, University of Illinois Law Review, 2007
Amy Monahan, University of Missouri at Columbia - School of Law
Date Posted: September 20, 2006
Last Revised: September 22, 2006
Accepted Paper Series
39 downloads - In Sickness, Health, and Cyberspace: Protecting the Security of Electronic Private Health Information - Case Legal Studies Research Paper No. 06-15
Sharona Hoffman and Andy Podgurski, Case Western Reserve University - School of Law and Case Western Reserve University
Date Posted: September 20, 2006
Last Revised: September 20, 2006
Working Paper Series
3 downloads - Oy Canada! Trade's Non-Solution to 'the Problem' of U.S. Drug Prices - U of Maryland Legal Studies Research Paper No. 2006-31, American Journal of Law & Medicine, Vol. 32, pp. 247-277, 2006
Daniel J. Gilman, University of Maryland - School of Law
Date Posted: September 13, 2006
Last Revised: September 26, 2006
Accepted Paper Series
11 downloads - Copayments in the German Health System - Do They Work? - RWI Discussion Paper No. 43
Boris Augurzky, Thomas K. Bauer and Sandra Schaffner, Rhine-Westphalia Institute for Economic Research (RWI-Essen) - General , Rhine-Westphalia Institute for Economic Research (RWI-Essen) and RWI Essen
Date Posted: September 8, 2006
Last Revised: September 8, 2006
Working Paper Series
21 downloads
Monday, October 02, 2006
More on the Provena tax-exemption case
For an extremely helpful analysis of all the issues -- prepared by Linda Sauser Moroney, a partner in the Milwaukee office of Gardner Carton & Douglas, and her colleagues T.J. Sullivan and Karen McAfee (partner and counsel to the firm, respectively, in its Washington office) -- go here (pdf).
Sunday, October 01, 2006
GAO report on emergency medical services post-Katrina
Summary findings:
While New Orleans continues to face a range of health care challenges, hospital officials in the greater New Orleans area reported in April 2006 that a sufficient number of staffed inpatient beds existed for all services except for psychiatric care -- some psychiatric patients had to be transferred out of the area because of a lack of beds. Overall, as of April 2006, the greater New Orleans area had about 3.2 staffed beds per 1,000 population, compared with the national average of 2.8 staffed beds per 1,000 population reported by the American Hospital Association. Hospital officials told us that they planned to open an additional 674 staffed beds by the end of 2006 -- 390 of which would be at University Hospital -- although they also reported that recruiting, hiring, and retaining nurses and support staff was a great challenge. With the addition of these beds, the population would have to increase from 588,000 in April 2006 to 913,000 by December 2006 before staffed beds would drop to the national average. For all types of care, eight of the nine hospitals we contacted provided us with an estimated overall occupancy rate for the 9-month period following the hurricane (through April 2006) and for the 12-month period before the hurricane. The hospitals’ occupancy rates for the 9-month period after the hurricane ranged from 45 percent to 100 percent, or an average of 77 percent, compared with a range from 33 percent to 85 percent, or an average of 70 percent, for the 12-month period before the hurricane. The American Hospital Association reported that the average monthly hospital occupancy rate nationwide was 67 percent in 2004. Eight of the nine hospitals that remained open after Hurricane Katrina also reported a high demand for services in their emergency departments, similar to the nationwide trend reported by the Institute of Medicine in June 2006 that emergency department crowding is a nationwide problem.
Cancer treatment @ $4200 a pop: is it worth it?
What is wrong with this picture?The drug, Abraxane, does not help patients live longer than the older treatment, though it does shrink tumors in more patients, according to clinical trials. And the old and new medicines have similar side effects. An independent review of Abraxane published in December in a cancer research journal concluded that the drug was “old wine in a new bottle.”
Still, Dr. Soon-Shiong’s company, Abraxis BioScience, has promoted Abraxane as a major advance in treating late-stage breast cancer — that is, for patients who have not responded to other treatments and are now close to death —and is seeking approval for patients to use it earlier in their treatment. And, in at least one way, Abraxane is a breakthrough: it costs about 25 times as much as a generic version of the older medicine, which is best known by its brand name, Taxol.Because of the odd economics of the cancer drug market, though, Abraxane’s price does not seem to be hurting its popularity.
About 20,000 people have now been treated with the drug, and Dr. Soon-Shiong expects its sales to approach $200 million this year. By 2010, Abraxane’s annual sales could reach $1 billion, analysts say.
Those rosy forecasts illustrate the pricing power that makers of cancer drugs wield. With patients often facing grim prognoses and desperate for new therapies, and insurers relatively powerless to negotiate prices or deny coverage, the cost of treatments seems to have little impact on demand.
The rise in cancer-drug prices is a microcosm of broader trends pushing up health care costs nationally. Despite decades of efforts by governments and insurers to restrain costs, patients continue to want the newest — and most expensive — drugs and medical devices. And doctors and the health care industry have little reason to keep costs in check, because insurers rarely deny coverage for new treatments on the basis of price.
As a result, health care costs continue to skyrocket. On Tuesday, the Kaiser Family Foundation reported that the cost of employee health insurance coverage rose 8 percent, according to a survey conducted from January to May this year. Businesses now spend about $8,500 a year for health insurance for the average family, the foundation said, with employees adding $3,000, not counting the cost of deductibles and other out-of-pocket payments.]
Abraxane, and cancer drugs generally, are still a tiny part of total medical spending. But their costs are rising even faster than overall health care inflation. Worldwide, spending on cancer drugs is expected to more than double from 2004 to 2009, to $55 billion, with most of that in the United States.
Largely as a result of investor enthusiasm for Abraxane, the stock market value of Abraxis is $4.6 billion. The company, which also makes several generic drugs used in hospitals, had a profit of $86 million last year on sales of $519 million. Dr. Soon-Shiong, the company’s chairman, owns 84 percent of the stock, worth about $3.8 billion.
Friday, September 29, 2006
Ill. rules against Provena in property-tax case
Last month, the Chicago Tribune reported "the cost to the hospital has been nearly $5 million since it lost its tax-exempt status in January 2003. The hospital says the taxes have been a drain on its balance sheet. The hospital lost $7.9 million last year on $127.9 million in revenue and is projecting a loss again this year." Hospital losing money as tax-exempt appeal languishes, Chicago Tribune, Sept. 7, 2006.The director of the Illinois Department of Revenue [link] rejected an appeal by Provena Health, Mokena, Ill. [link], in a widely watched property-tax exemption case. [See previous posts here, here, and here.] In doing so, the director overruled an administrative law judge in the department who had sided with the not-for-profit system. Provena said it "will quickly and aggressively appeal" department director Brian Hamer's decision [news release]. At stake is some $1.5 million in annual property taxes, according to county tax officials. Provena has paid taxes on property in Urbana, Ill., including its 120-bed hospital there and medical-office buildings, since 2003, while the system appealed the state's initial denial of its request for a property-tax exemption. Rejecting the administrative law judge's ruling in favor of an exemption, Hamer said the property was not used exclusively for charitable purposes.
Latest from AHLA's Health Lawyers Weekly (29 Sep 2006)
Top Stories
- IOM Issues Recommendations For Improving FDA Post-Market Drug Surveillance -- The Food and Drug Administration’s (FDA's) ability to oversee the safety of prescription drugs after they hit the market is undermined by a number of systemic deficiencies--including chronic under funding, organizational problems, and inadequate data--that require far-reaching changes to address, according to a new report by the Institute of Medicine (IOM) of the National Academies. Full Story
- Health Insurance Premiums Rose More Than Twice As Fast As Inflation In 2006, Report Finds -- Premiums for employer-sponsored health insurance rose an average of 7.7% in 2006, more than twice as fast as workers' wages (3.8%) and overall inflation (3.5%), according to the 2006 Health Benefits Survey released September 26 by the Kaiser Family Foundation and the Health Research and Educational Trust (HRET). Full Story
Articles & Analyses
- CMS Announces Revisions To The Emergency Medical Treatment And Active Labor Act, By Adrienne Marting and Raquel Gayle, Powell Goldstein LLP
Current Topics
- DHHS
1. OIG Issues FY 2007 Work Plan
2. Leavitt Names Norwalk Acting CMS Administrator- Food and Drug Law
Homeland Security Conferees Agree To Limited Drug Importation Provision- Fraud and Abuse
1. OIG Approves Charitable Organization’s Proposed Grants To Financially Needy With Certain Diseases To Defray Costs Of Medicare Premiums
2. Update
3. U.S. Court In Pennsylvania Allows Qui Tam Case To Go Forward, Says Specifics Of False Claims Not Necessary
4. OIG Approves Two Cities’ Exclusive Contracts For Non-Emergency Inter-Facility Ambulance Transport Services
5. DHHS OKs Drug Maker’s Pharmaceutical Assistance Program For Financially Needy Part D Enrollees
6. State MFCUs Report Over $1 Billion In Recoveries In FYs 2004 And 2005
7. Tenet Executes Five-Year CIA With OIG- Health Policy
1. Group Makes Recommendations For Better Healthcare System
2. House Ways And Means Committee Approves Bill To Increase Use Of
HSAs- HIPAA
U.S. Court In Nebraska Finds Physician Cannot Pursue Claims Against Hospital For Disclosing His Drug/Alcohol Treatment- Hospitals and Health Systems
1. Montana Supreme Court Finds Clinic Owes No Duty To Victims Of Car Crash Caused By Patient Seen At Clinic
2. Emergency Department Crowding Common, CDC Study Finds- Managed Care
Illinois Supreme Court Strikes Down Percentage-Based Fee-Splitting Provision In Healthcare Company’s Participating Provider Agreements- Medical Malpractice
1. Indiana Appeals Court Finds Psychiatric Patient’s Claims Not Subject To Medical Malpractice Statute
2. Florida Appeals Court Upholds Jury’s Finding That Physician's Negligence Caused Elderly Patient’s Death Following Car Accident- Medicare
1. U.S. Court In Indiana Rejects Hospitals’ Bid For Retroactive Adjustment Of Their Outlier Payments
2. Federal Judge Enjoins CMS From Collecting Incorrect Medicare Part D Payments
3. CMS Overpaid IRFs Almost $12 Million, OIG Finds- News in Brief
DHHS Partners With States To Promote Long Term Care Planning- Quality of Care
1. NCQA Finds Health Plans' Quality Gains Continue, Says Accountability Is Key(c) 2006 AHLA. Reprinted with permission
Thursday, September 28, 2006
Public hospital governance manual
Wednesday, September 27, 2006
Health costs' rate of increase down, but still 'way ahead of inflation, family incomes
- "Health Care Costs Rise Twice As Fast As Inflation," by Milt Freudenheim:
A widely followed national survey reported yesterday that the cost of employee health care coverage rose 7.7 percent this year, more than double the overall inflation rate and well ahead of the increase in the incomes of workers.
The 7.7 percent increase was the lowest since 1999. But the average cost to employees continued an upward trend, reaching $2,973 annually for family coverage out of a total cost of $11,481.
Since 2000, the cost of family coverage has risen 87 percent while consumer prices are up 18 percent and the pay of workers has increased 20 percent, the survey noted. That is without counting the cost of deductibles and other out-of-pocket payments, which have also been rising.
- "The Choice: A Longer Life or More Stuff," by David Leonhardt:
There's more, and it's all worth reading.These spiraling costs — a phrase that has virtually become a prefix for the words “health care” — are slowly creating a crisis. Many executives have decided that they cannot afford to keep insuring their workers, and the portion of Americans without coverage has jumped 23 percent since 1987.
An industry that once defined the American economy, meanwhile, is sinking in large measure because of the cost of caring for its workers and retirees. For every vehicle that General Motors sells, fully $1,500 of the purchase price goes to pay for medical care. “We must all do more to cut costs,” G.M.’s chief executive, Rick Wagoner, said on Capitol Hill this summer while testifying about health care.
Mr. Wagoner’s argument has become the accepted wisdom about the crisis: the solution lies in restraining costs. Yet it’s wrong. Living in a society that spends a lot of money on medical care creates real problems, but it also has something in common with getting old. It’s better than the alternative.
To understand why, it helps to look back to a time when Americans didn’t worry much about health care costs. In 1950, the country spent less than $100 a year — or $500 in today’s dollars — on the average person’s medical care, compared with almost $6,000 now, notes David M. Cutler, an economist who wrote a wonderful little book in 2004 titled, “Your Money or Your Life.”Most families in the 1950’s paid their medical bills with ease, but they also didn’t expect much in return. After a century of basic health improvements like indoor plumbing and penicillin, many experts thought that human beings were approaching the limits of longevity. “Modern medicine has little to offer for the prevention or treatment of chronic and degenerative diseases,” the biologist René Dubos wrote in the 1960’s.
But then doctors figured out that high blood pressure and high cholesterol caused heart attacks, and they developed new treatments. Oncologists learned how to attack leukemia, enabling most children who receive a diagnosis of it today to triumph over a disease that was almost inevitably fatal a half-century ago. In the last few years, orphan drugs that combat rare diseases and medical devices like the implantable defibrillator have extended lives. Human longevity still hasn’t hit the wall that was feared 50 years ago.
Instead, a baby born in the United States this year will live to age 78 on average, a decade longer than the average baby born in 1950. People who have already made it to their 40’s can now expect to reach age 80. These gains are probably bigger than the ones the British experienced in the entire millennium leading up to 1800. If you think about this as the return on the investments in medicine, the payoff has been fabulous: Would you prefer spending an extra $5,500 on health care every year — or losing 10 years off your lifespan?
Yet we often imagine that the costs and benefits are unrelated, that we can somehow have 2006 health care at 1950 (or even 1999) prices. We think of health care as if it were gasoline, a product whose price and quality have nothing to do with each other.
There is no question that the American medical system does suffer from a lot of waste, be it insurance industry bureaucracy or expensive procedures that haven’t been proven effective. But the No. 1 cause of the cost increases is still the one you can see at the hospital and in your medicine cabinet — defibrillators, chemotherapy, cholesterol drugs, neonatal care and other treatments that are both expensive and effective.
Not even most forms of preventive care, like keeping diabetes under control, usually save money, despite what many people think. The care itself has some costs, and, more important, patients then live longer than they otherwise would have and rack up medical bills. “When I make this point, people accuse me of wanting people to die earlier. But it’s exactly the opposite,” Dr. Jay Bhattacharya, a researcher at Stanford Medical School, told me. “If these expenditures are keeping people alive, it’s money well spent.”
Tuesday, September 26, 2006
"Excited delirium": legitimate diagnosis or another name for "police brutality"?
Expect a bucketful of litigation over this concept in policy-brutality cases in the coming years. For further reading on this topic, take a look at:Police found 23-year-old Jose Romero in his underwear, screaming gibberish and waving a large kitchen knife from his neighbor's porch.
Romero kept approaching with the knife, so officers shocked him repeatedly with a stun gun.
Then he stopped breathing. His family blames police brutality for the death, but the Dallas County medical examiner attributed it to a disputed condition known as "excited delirium."
Excited delirium is defined as a condition in which the heart races wildly - often because of drug use or mental illness - and finally gives out.
Medical examiners nationwide are increasingly citing the condition when suspects die in police custody. But some doctors say the rare syndrome is being overdiagnosed, and some civil rights groups question whether it exists at all.
"For psychiatrists, this is a rare condition that occurs once in a blue moon," said Warren Spitz, a former chief medical examiner in Michigan. "Now suddenly you are seeing it all the time among medical examiners. And always, police and police restraint are involved." * * *The chief psychiatric reference book, The Diagnostic and Statistical Manual of Mental Disorders [link], does not specifically recognize "excited delirium" as a diagnosis. The International Association of Chiefs of Police [link] says not enough is known about it.
"It is not a recognized medical or psychiatric condition," said spokeswoman Wendy Balazik. "That is why we don't use it and have not taken a position on it."
Dr. Matthew D. Sztajnkrycer [link], an emergency room doctor for 10 years and associate professor at the Mayo Clinic in Minnesota, said he has seen cases of excited delirium but has many questions about it.
"It is not like a heart attack where you can just get a blood test and know you have the right diagnosis," he said. "Part of the problem is that post-mortem there is a paucity of physical evidence."
- "Excited Delirium Syndrome: Cause of Death and Prevention," by DiMaio and DiMaio;
- O'Halloran RL, Lewman LV. Restraint asphyxiation in excited delirium. Am J Forensic Med Pathol, 1993;14(4):289-295
- M. S. Pollanen, D. A. Chiasson, T. J. Cairns and J. G. Young, Unexpected death related to restraint for excited delirium: a retrospective study of deaths in police custody and in the community. Canadian Medical Association Journal, 1998;158:1603-1607