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
Monday, March 05, 2007
GAO testimony on DOD/VA care problems for injured soldiers, vets
It may be true, as Paul Krugman writes in today's op-ed (paid TimesSelect subscription required) in the N.Y. Times, that the worst of the worst in terms of quality care (or the lack thereof) is in the military hospitals, which are separate and distinct from the VA. And the VA may still be the exemplar of quality that it's been touted to be for the past 10 years (although that's not what I hear from the medical students who rotate through the VA hospital here, and that's not the message from vets in today's Post article by Hull and Priest). But the testimony of the GAO witness documents some of the ways that the care in the VA system breaks down when a patient is handed off from the military's hospital system to the VA's.
To be middle-class and uninsured
The article offers a good illustration of the problems encountered by the uninsured.[T]he uninsured are not necessarily the poor, the unemployed and the undocumented. Solidly middle-class people like Ms. Readling are one of the fastest growing subgroups.
And that is one reason, according to a recent New York Times/CBS News poll, that the problems of the uninsured have jumped to the top of the domestic political agenda in Washington and on the campaign trail.
Today, more than one-third of the uninsured — 17 million of the nearly 47 million — have family incomes of $40,000 or more, according to the Employee Benefit Research Institute, a nonpartisan organization. More than two-thirds of the uninsured are in households with at least one full-time worker.
Undertreatment and general mismanagement of chronic conditions will, in the long run, result in more expense, not less, but if short-term cash flow makes the cost of care prohibitively expensive, where's the safety net for patients like Ms. Readling? It doesn't exist.To save money, Ms. Readling said, she defers visits to the doctor and stretches out her cancer medication, which costs her about $300 a month. She takes the tiny pills three or four times a week, rather than seven days a week as prescribed.
“I really try to stay away from the doctor because I am so scared of what everything will cost,” said Ms. Readling, who is divorced and has twin 18-year-old sons. Before every doctor’s visit and test, she asks, “How much are you going to charge me?” She says she tries to arrange “the best deals I can.”
But in many cases, the price is still unaffordable, and “I have to do without.”
Wednesday, February 28, 2007
Washington state courts publish public health emergency bench book
NY Times article on the pervasive -- and perverse -- presence of IRBs on campus
Tuesday, February 27, 2007
Second Champaign hospital loses its exempt status
The Board of Review's letter brief argued that the hospital was guilty of inurement by providing a practice platform for the for-profit physician group that operated it. Granted, this is the position of a single taxing authority (and maybe the state as well), but if that analysis is adopted widely, a lot of multi-specialty physician groups (at least the ones that aren't organized as nonprofits) with an affiliated health or hospital group are going to want to take a close look at whether they are organized and operated for a charitable purpose. Every entity's facts will be a little different, and exempt status is a "facts and circumstances" determination, but counsel for any such organization will want to pay close attention to the County's analysis of the inurement issue, as well as the other facts relied on in their brief.
Monday, February 26, 2007
Everything you always wanted to know about nanotechnology but were afraid to ask
If you're coming to the nanotech party a little late, a good place to start would be the federal government's National Nanotechnology Initiative:
The National Nanotechnology Initiative (NNI) is a federal R&D program established to coordinate the multiagency efforts in nanoscale science, engineering, and technology.
The goals of the NNI are to:
- Maintain a world-class research and development program aimed at realizing the full potential of nanotechnology;
- Facilitate transfer of new technologies into products for economic growth, jobs, and other public benefit;
- Develop educational resources, a skilled workforce, and the supporting infrastructure and tools to advance nanotechnology; and,
- Support responsible development of nanotechnology
Twenty-five federal agencies participate in the Initiative, 13 of which have an R&D budget for nanotechnology. Other Federal organizations contribute with studies,
applications of the results from those agencies performing R&D, and other collaborations. (See NNI Participants and NNI Structure and Strategies)
Monday, February 12, 2007
Lethal injection: what does the physicians' non-role portend?
AHLA's Health Lawyers Weekly (Feb. 9)
Top Stories
- President Bush Issues FY 2008 Budget, Calls For Substantial Medicare, Medicaid Reductions
President Bush issued his fiscal year (FY) 2008 budget proposal this week, calling for roughly $101 billion in savings from Medicare and Medicaid over five years. Full Story - CMS Reports More Medicare Part D Beneficiaries Using Generic Drugs
New data indicates that many Americans are saving money by switching to generic drugs, according to the Centers for Medicare and Medicaid Services (CMS). Full Story
Articles & Analyses
- Michigan Legislature Passes Provisional Nurse Licensure Statute, by Gregory W. Moore, Hall Render, Killian Heath and Lyman
Current Topics
- Arbitration/Mediation
Ohio Appeals Court Upholds Nursing Home Arbitration Agreement Finding Procedural But Not Substantive Unconscionability - Business Transactions
Seventh Circuit Holds Management Company Breached Lease Agreement When Intermediary Care Facility Lost State CON - ERISA
U.S. Court In Michigan Finds Plan Member Has Standing To Sue Under ERISA Even Without Proof Of Personal Injury - Food and Drug Law
Drug Safety Legislation Introduced In Senate - Fraud and Abuse
1. Update
2. U.S. Court In Arkansas Dismisses FCA Qui Tam Action Against Hospital And Rehabilitation Services Provider On Finding Of Insufficient Evidence - Health Policy
Major Employers, Union Team Up To Improve Healthcare System - Healthcare Access
Workers' Decision To Participate In Employer-Sponsored Health Insurance Plans Affected By Affordability Of Premiums, Study Finds - HIPAA
U.S. Court In Connecticut Says HIPAA Does Not Bar Ex Parte Interviews With Employees At Group Home Where Plaintiff Was Allegedly Neglected - Hospitals and Health Systems
1. Texas Appeals Court Finds Hospital District Waived Its Immunity By Filing Counterclaim To Physicians' Retaliatory Discharge Claims
2. Lawmakers Question CMS About Specialty Hospital Following Patient Death In Texas - Insurance
U.S. Court In Texas Dismisses Hospital's Claims Against Plan Administrator After Plan Refused To Pay Because Of Pre-Existing Condition Exclusion - Medicaid
Study Finds Six States Have Reported Enrollment Drop Since Implementing New Medicaid Documentation Requirements - Medicare
1. OIG Presents Baseline Data On Medicare Part B Services For Nursing Home Residents
2. U.S. Court In Tennessee Rejects MSP Action By Individual Claiming Standing As Qui Tam Relator - News in Brief
Low Health Literacy May Lead To Unsafe Care, Joint Commission Says - Physicians
Ninth Circuit Allows Physician To Proceed With Retaliatory Termination, Unfair Competition Claims Against IPA - Quality of Care
1. Most Patients Do Not Comparison Shop For Healthcare Services, Study Finds
2. Public Reporting Efforts Help Improve Quality Of Care But Implementation Obstacles Remain, Report Says - Tax
IRS Issues Governance Guidelines For Charitable Organizations
(c) 2007, reprinted with permission of AHLA
Sunday, February 11, 2007
Texas' HPV vaccination mandate: upon further reflection . . . .
- Although you note the “opt out” approach taken by Gov. Rick Perry of Texas in which vaccination is required but parents can seek an exemption for reasons of conscience or religious beliefs, recommending the vaccine rather than requiring it could prove to be just as effective without violating the parents’ right to decide affirmatively — at least until the long-term effects are known. Amanda Styron
- Schools may rightfully require that children undergo immunizations that will protect schoolwide populations from acquiring communicable diseases, but cervical cancer does not fall into this category. However benevolent the intent, this is not a matter for Big Brother. Alan Katz
- In Texas, underscreening in African-American and Hispanic women probably accounts for their disproportionately high rates of cervical cancer. These adult women need access and coverage for screening. Unfortunately, there is no lobby for the Pap smear. Deborah Kamali, M.D.
- Compulsory vaccination has a legitimate place in our health care system. But why should the government restrict its vaccinations to the victims? Why not include the carriers? Sue Abercrombie
- Texas will pay hundreds of dollars per girl for the vaccination. Why not spend the money on health care, education about teenagers’ bodies and rights, enriching music, dance, art and science programs that engage, increase confidence and provide an alternative to sexual activity? What kind of people supply schoolgirls to a pharmaceutical company, allowing it to earn millions a year on such mandates? Elizabeth Beiter
Saturday, February 10, 2007
Hospice - rethought and revised
Monday, January 29, 2007
Does anyone know what John Kitzhaber's been up to since he stopped being governor of Oregon? The Archimedes Movement. Check it out.
Monday, January 15, 2007
AHLA's Health Lawyers Weekly (12 Jan 07)
Top Stories
- House Passes Bill Requiring Medicare Prescription Drug Price Negotiation; Bush Threatens Veto
President George W. Bush has threatened to veto a bipartisan bill that would require the Secretary of the Department of Health and Human Services (DHHS) to negotiate for lower prescription drug prices on behalf of Medicare. The House passed the bill January 12 by a vote of 255 to 170. Full Story - House Clears Stem Cell Bill
As expected, the House passed January 11 a bill aimed at expanding research opportunities on embryonic stem cells. The measure cleared the House by a 253-174 margin, short of the two-thirds majority needed to override a presedential veto. Full Story
Articles & Analyses
- Department Of Justice Revises Policies On Waiver Of The Attorney-Client Privilege In Corporate Fraud InvestigationsBy Joseph Burby, Jennifer Odom, and Kenneth Schwartz, Powell Goldstein LLP
. . . and many news items of note.
Sunday, January 14, 2007
GAO reports from November
- End-Stage Renal Disease: Bundling Medicare's Payment for drugs with Payment for All ESRD Services Would Promote Efficiency and Clinical Flexibility. GAO-07-77, November 13, 2006 (35 pages). http://www.gao.gov/docdblite/details.php?rptno=GAO-07-77
- End-Stage Renal Disease: Medicare Payments for All ESRD Services,Including Injectable Drugs, Should Be Bundled. GAO-07-266T,December 6, 2006 (5 pages). http://www.gao.gov/docdblite/details.php?rptno=GAO-07-266T
- Long-Term Care Insurance: Federal Program Has a Unique Profit Structure and Faced a Significant Marketing Challenge.GAO-07-202, December 29, 2006 (29 pages). http://www.gao.gov/docdblite/details.php?rptno=GAO-07-202
- New Drug Development: Science, Business, Regulatory, and Intellectual Property Issues Cited as Hampering Drug Development Efforts. GAO-07-49, November 17, 2006 (47
pages). http://www.gao.gov/docdblite/details.php?rptno=GAO-07-49 - Prescription Drugs: Improvements Needed in FDA's Oversight of Direct-to-Consumer Advertising. GAO-07-54, November 16, 2006 (47 pages). http://www.gao.gov/docdblite/details.php?rptno=GAO-07-54
Saturday, January 13, 2007
Health Affairs' 25 most-read articles of 2006
Health Affairs’ 25 Most-Read Articles From 2006
To celebrate the start of Health Affairs’ 25th anniversary year, we list here the 25 most frequently viewed articles published in 2006. In 2006, Health Affairs’’ Web readership grew to 12 million pageviews.
The paper on nurse staffing in hospitals by Jack Needleman and colleagues took the top spot for a paper published in 2006 with 37,547 pageviews. Two papers from 2005 earned the “most-read overall” ranking: “Can Electronic Medical Record Systems Transform Health Care?” by Richard Hillestad and colleagues from Health Affairs’ September/October 2005 issue attracted 40,263 pageviews in 2006, and the medical bankruptcy Web Exclusive by David Himmelstein and colleagues from February 2005 continued its high readership, adding 39,262 pageviews in 2006 to its over 70,000 pageviews from 2005, thus surpassing 100,000 readings of the paper.
25 Most-Read Health Affairs Papers Published in 2006: http://www.healthaffairs.org/Top25_2006_MostRead.php
25 Most-Read Health Affairs Papers Overall Online in 2006: http://www.healthaffairs.org/Top25_2006_MostRead_Overall.phpWe are sending this notice to subscribers so you may see which papers your cohorts viewed most often at www.healthaffairs.org. As a subscriber you have online access to these papers and to all journal content. To celebrate our 25th anniversary, we are opening access to the 25 papers from 2006 through January 19, 2007, so you may share these with colleagues, students and others who may not currently have access.
(emphasis added)
Wednesday, January 10, 2007
AHLA's Health Lawyers News (5 January 2007)
Top Stories
- Medicaid Commission Issues Final Report On Medicaid Reform
The Medicaid Commission said "fundamental reform" is needed to shore up the long term sustainability of the federal-state Medicaid program in a final report issued December 29 that details its recommendations for achieving that end. Full Story - OIG Finds Only Three Of Ten State False Claims Acts Submitted For Review Comply With DRA Requirements
The Department of Health and Human Services Office of Inspector General (OIG) has determined that only three of ten state False Claims Acts (FCAs) that it recently reviewed comply with all the requirements set forth in the Deficit Reduction Act of 2005 (DRA) to be eligible for the financial incentive bonus, according to information posted on OIG's website December 29. Full Story
Articles & Analyses
- Congress Approves Medicare, Medicaid Changes, by Karen S. Sealander and Eric Zimmerman, McDermott Will & Emery LLP
- CMS Issues Long-Awaited DRA Compliance Guidance And Teleconference, by Elizabeth Callahan-Morris, Hall, Render, Killian, Heath & Lyman, PLLC
. . . and many news items of note.
Monday, January 08, 2007
Another angle on middlemen
* Krugman's column is here, which is a TimesSelect address that requires a paid subscription. There's a good summary over at Mark Thoma's blog.
Tuesday, January 02, 2007
HIPAA privacy rule: Is it time for (re)reform?
"[I]ncreasingly complex confidentiality issues" in federal medical privacy rules "are affecting patients and their insurance coverage," the Wall Street Journal reports. According to the Journal, complaints of privacy violations "have been piling up." Between April 2003 and Nov. 30, 2006, HHS received 23,896 complaints related to medical-privacy rules. An HHS spokesperson said 75% of those complaints have been closed because no violations were found or informal guidance was provided to involved parties. Since HIPAA was enacted in 2003, HHS has not taken enforcement actions against any entity for violating the privacy rule. The Journal profiled attorney Patricia Galvin, who was denied disability benefits after her health insurer, UnumProvident, accessed notes from psychotherapy sessions at Stanford Hospital & Clinics. According to the Journal, UnumProvident said the notes indicated that Galvin was not "too injured to work" after she was involved in a car accident and applied for long-term disability leave. UnumProvident had asked Galvin to sign a broad release to access her basic medical records, which included some of the psychotherapist's notes about Galvin that Stanford had scanned into its computer records system. Galvin has filed a lawsuit against Stanford and UnumProvident for violating medical privacy laws, among other issues, under the federal Health Insurance Portability and Accountability Act. HIPAA includes added protection for mental health records, but Stanford in court papers said that "psychotherapy notes that are kept together with the patient's other medical records are not defined as 'psychotherapy' notes under HIPAA." Peter Swire, a law professor at Ohio State University who helped write the regulations, said, "We're three years into the enforcement of the rule, and they haven't brought their first enforcement initiative." He added, "It sends the signal that the health system can ignore this issue" (Francis, Wall Street Journal, 12/26/06).
Monday, January 01, 2007
Krugman touts single-payer system
The U.S. health care system is a scandal and a disgrace. But maybe, just maybe, 2007 will be the year we start the move toward universal coverage.
In 2005, almost 47 million Americans — including more than 8 million children — were uninsured, and many more had inadequate insurance.
Apologists for our system try to minimize the significance of these numbers. Many of the uninsured, asserted the 2004 Economic Report of the President, “remain uninsured as a matter of choice.”
And then you wake up. A scathing article in yesterday’s Los Angeles Times described how insurers refuse to cover anyone with even the slightest hint of a pre-existing condition. People have been denied insurance for reasons that range from childhood asthma to a “past bout of jock itch.”
Some say that we can’t afford universal health care, even though every year lack of insurance plunges millions of Americans into severe financial distress and sends thousands to an early grave. But every other advanced country somehow manages to provide all its citizens with essential care. The only reason universal coverage seems hard to achieve here is the spectacular inefficiency of the U.S. health care system. . . .
The truth is that we can afford to cover the uninsured. What we can’t afford is to keep going without a universal health care system.If it were up to me, we’d have a Medicare-like system for everyone, paid for by a dedicated tax that for most people would be less than they or their employers currently pay in insurance premiums. This would, at a stroke, cover the uninsured, greatly reduce administrative costs and make it much easier to work on preventive care.
Such a system would leave people with the right to choose their own doctors, and with other choices as well: Medicare currently lets people apply their benefits to H.M.O.’s run by private insurance companies, and there’s no reason why similar options shouldn’t be available in a system of Medicare for all. But everyone would be in the system, one way or another. . . .
But now is the time to warn against plans that try to cover the uninsured without taking on the fundamental sources of our health system’s inefficiency. What’s wrong with both the Massachusetts plan and Senator Wyden’s plan is that they don’t operate like Medicare; instead, they funnel the money through private insurance companies.
Everyone knows why: would-be reformers are trying to avoid too strong a backlash from the insurance industry and other players who profit from our current system’s irrationality. But look at what happened to Bill Clinton. He rejected a single-payer approach, even though he understood its merits, in favor of a complex plan that was supposed to co-opt private insurance companies by giving them a largely gratuitous role. And the reward for this “pragmatism” was that insurance companies went all-out against his plan anyway, with the notorious “Harry and Louise” ads that, yes, mocked the plan’s complexity.
Now we have another chance for fundamental health care reform. Let’s not blow that chance with a pre-emptive surrender to the special interests.
The L.A. Times story to which Krugman refers is a corker. It's also a good reminder that HIPAA's pre-existing condition reforms did not apply to individual policies, a particularly cruel fate for the millions of Americans for whom group policies are unavailable, either because their employer doesn't offer health benefits or because they are self-employed.
Sunday, December 31, 2006
Single-payer system for the US: you heard it here last
CBO and tax-exempt hospitals
1. Nonprofit Hospitals and the Provision of Community Benefits. How much tax benefit do nonprofit hospitals receive as a result of their exemption from federal, state, and local taxation? Answer (as of 2002): $12.6 billion, about half of which comes from the federal income-tax exemption. And what is the value of the community benefits provided by the tax-exempts? Therein lies a tale, because it all depends on how you define (and measure) community benefits. This report breaks out "uncompensated care" (also a thorny definitional problem), the unreimbursed cost of providing Medicaid-covered services, and such generally unprofitable specialized services as burn intensive care, emergency room care, high-level trauma care, and labor and delivery services. This reports limits itself to five states, including one (Texas) with a very explicit community-benefits requirement for nonprofit hospitals. The tax-exempt hospitals' performance in these three areas of service are also compared to their for-profit and government-owned counterparts. How do they compare?
- When regression techniques were used to adjust for the hospitals’ size and location and for the characteristics of the local populations, nonprofit hospitals were estimated to have an average uncompensated care share that was 0.6 percentage points higher than that for otherwise similar for-profit hospitals. That estimated difference corresponds to nonprofit hospitals in the five selected states providing between $100 million and $700 million more in uncompensated care than would have been provided if they had been for-profits.
- When regression techniques were used to control for hospital characteristics, nonprofit hospitals were found to have adjusted Medicaid shares that were 1.3 percentage points lower than those of otherwise similar for-profit hospitals.
- CBO found that nonprofit hospitals were more likely than for-profit hospitals to provide each of the four specialized services examined. After adjustment for hospital characteristics, nonprofit hospitals were found to be significantly more likely than for-profit hospitals to provide two of the four specialized patient services (emergency room care and labor and delivery services).
2. Nonprofit Hospitals and Tax Arbitrage. This one's a little more technical. It deals with the ability of tax-exempt hospitals to borrow at below-market rates by issuing tax-exempt bonds and then deploy the borrowed funds for higher-yielding investments. So-called "arbitrage bonds," however, are not exempt from federal taxes, which removed the main incentive to engage in such practices. That said, there are plenty of other opportunities for nonprofit hospitals to engage in a sort of tax arbitrage, and this report analyzes some of them. One occurs when a tax-exempt entity decides to invest some of its accumulated surplus and gifts in high-yield taxable securities and to finance structures and equipment with low-cost exempt bonds. In economic terms, it's the same as if bond proceeds were being invested in securities, and there's a "replacement proceeds rule" (26 CFR § 1.148-1(c)) that attempts to identify such events and subject them to taxation. But for a variety of reasons the rule is difficult to apply and undoubtedly misses a lot of such tax-arbitrage activity. The CBO report considers the possibility of broadening the definition of tax arbitrage, which they conclude would probably result in increased tax revenues for the federal government, at least in the short run. But over time, it seems likely hospitals would adjust to the new (increased) cost of capital by reducing their level of arbitrage bond issues, resulting in a decrease in tax savings for the federal government, even under the broader definition. A second likely effect would be
two different costs of capital for nonprofit hospitals. Nonprofits with larger portfolios of investment assets would be more likely to be subject to the rule and thus effectively face higher interest costs associated with financing using taxable debt. Hospitals with smaller amounts of such assets would be more likely to continue to receive the benefit of tax-exempt financing. Both would still face lower costs of capital than for-profit hospitals. But the different borrowing costs of the two groups of nonprofit hospitals could engender inefficiencies by creating a new differential in capital costs.