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
Saturday, June 02, 2007
Dr. Death out of prison
Dutch reality tv program -- "Big Donor Show" -- a hoax
It appears that organ-transplant officials the world over are a pretty conservative lot, adverse to publicity that could be seen as sensationalistic in any way, and of course there was plenty about this "show" not to like. But count this episode as one of many that illustrate the widespread feeling of frustration that "business as usual" isn't getting the job done in the organ-transplant field. The waiting-list statistics at UNOS tell a pretty grim tale:
- there are currently 96,047 registered patients on various waiting lists
- over the past 5 years, waiting-list registrations have skyrocketed for livers, kidneys, and lungs; the number of transplants has increased modestly, and the number of patients who died waiting for a transplant has either gone up modestly (livers and kidneys) or stayed about the same (lungs) despite heroic efforts to increase donations; for hearts, the number of deaths on the list has gone down slightly, but not because of an increase in the number of transplants, which has stayed about the same:
Historians of organ transplantation may well look back on 2007 as the year of the first big crack in the facade. I am thinking of HHS' opinion earlier this year that the prohibition against buying and selling organs (42 U.S.C. § 274e) would not be violated by paired exchanges of living donor kidney transplants. This is the situation when A donates a kidney to D in exchange for C's donation of a kidney to B, where A would otherwise be a living related donor to B, and C would otherwise be a living related donor to D, but for A-B and C-D incompatibility. (A variation on this theme occurs when a living related donor who is incompatible with a family member on the waiting list donates to a stranger, in exchange for which the patient on the waiting list receives some priority on the waiting list, which may substantially shorten his or her waiting time.) Every first-year Contracts student can spot the valuable consideration in these arrangements, but DOJ said the practice does not violate federal law. It can only be a matter of time before the supposed distinction between mutual promises (or the performance thereof) and the exchange of cash for a promise (or performance thereof) will crumble.
Friday, June 01, 2007
Health Lawyers News, June 1
Top Stories
CMS Implements New Marketing, Education Requirements For PFFS Plans
Abby L. Block Director of the Centers for Medicare and Medicaid Services’ (CMS’) Center for Beneficiary Choices sent a memo May 29 to Medicare Advantage (MA) Private fee-for-service (PFFS) plans reminding them that CMS is requiring new outreach processes to ensure beneficiaries and providers are informed about the distinctive features of Medicare PFFS plans. Full StoryBaucus, Grassley Urge IRS To Update Reporting Forms For Nonprofits
Senate Finance Committee Chairman Max Baucus (D-MT) and Ranking Member Charles Grassley (R-IA) sent a letter May 25 to Treasury Secretary Henry Paulson urging him to update Form 990 and Form 990 PF that nonprofits file with the Internal Revenue Service (IRS) in order to gain greater transparency into the workings of tax-exempt organizations including charities. Full StoryArticles & Analyses
- Unionized Hospital Denied Antitrust Exemption In Nurses’ Suit, by Mark A. Hutcheson, Douglas C. Ross, Mary E. Drobka, and Charles S. Wright, Davis Wright Tremaine, LLP
Current Topics
- Criminal Law
D.C. Circuit Upholds Restitution Order Against Podiatrist Who Pled Guilty To Medicare Fraud- Fraud and Abuse
Sixteen Individuals Charged With Defrauding Medicare Of $101 Million In DME Billing Scheme- Update
- Healthcare Access
California Appeals Court Voids County’s Income Eligibility Cap For Subsistence Medical Care- Hospitals and Health Systems
1. Florida High Court Finds Hospital Has No Duty To Ensure Staff Physicians Have Malpractice Insurance
2. Florida Appeals Court Finds Hospital Owed No Duty of Care To Man Who Fainted After Viewing His Wife’s Emergency Treatment- Individual/Patient Rights
Second Circuit Finds Intended Organ Recipient Had No Property Right In Donated Kidney Because Of Incompatibility- Long Term Care
House Panel Investigating Deceptive Practices In Long Term Care Insurance Market- Medicaid
1. President Signs Supplemental War Spending Bill With SCHIP Funding And Moratorium On Medicaid Rule
2. CMS Issues Final Rule On State Medicaid Financing Arrangements
3. Ninth Circuit Upholds Oregon Plan Charging Individuals In Medicaid Expansion Group Higher Copays Than Other Medicaid Recipients- Medicare
1. CMS Proposes Non-Coverage Of LADR For Medicare Recipients Over 60
2. CMS Releases Measures For Evaluating Financial Health Of Suppliers Participating In New DMEPOS Competitive Bidding Program
3. CMS Clarifies Policy Relating To Part D Special Transition Period For Retroactive Enrollment
4. GAO Finds Most Employers Continued Retiree Drug Coverage, Opted For
Subsidy- News in Brief
1. PhRMA Adds Drug Safety Information To Its Website
2. AHRQ Adds New Web Tool For Healthcare Quality Report Cards- Patient Safety
Baucus,Grassley Introduce Bill Directed At Improving Research On Pharmaceutical Safety And Effectiveness- Physicians
1. Tennessee High Court Holds Information Otherwise Available From Original Sources Is Discoverable But Not From Peer Review Committee
2. Ohio High Court Strikes Down Rule Barring Anesthesiologist Assistants From Performing Epidural And Spinal Procedures- Tax
Eleventh Circuit Holds Medical Residents May Qualify For FICA Exemption
Thursday, May 31, 2007
NIH creates and confers new AID research awards
A joint award to Robert Yarchoan, M.D. and Hiroaki Mitsuya, M.D., Ph.D. of the National Cancer Institute — for their individual and combined achievements, groundbreaking discoveries and innovative and original scientific contributions that have significantly advanced HIV treatment research. Their landmark clinical studies, demonstrating that AZT could result in partial restoration of the immune response and temporary clinical benefit, established the first treatment for HIV infection and launched the era of effective therapy for HIV/AIDS. Their work significantly advanced this field, directly impacting on the development of new and better strategies to prevent and treat HIV disease in this country and around the world.
Wednesday, May 30, 2007
China's ex-regulator of food and drug gets death penalty
China's former top drug regulator was sentenced to death Tuesday for taking bribes to approve untested medicines, as the country's main quality control agency announced its first recall system targeting unsafe food products.
The developments are among the most dramatic steps Beijing has publicly taken to address domestic and international alarm over shoddy and unsafe Chinese goods -- from pet food ingredients and toothpaste mixed with industrial chemicals to tainted antibiotics.
The Beijing No. 1 Intermediate People's Court convicted Zheng Xiaoyu for taking bribes in cash and gifts worth more than $832,000 when he was director of the State Food and Drug Administration, the official Xinhua News Agency said. The court then issued the death penalty, the report said.
Tuesday, May 29, 2007
Dutch reality tv: who will get my kidney?
Monday, May 28, 2007
Emergency research protocols expand
Saturday, March 31, 2007
California health reform
Saturday, March 24, 2007
Living with an incurable genetic disease
Fen-phen lawyers defrauded plaintiffs, court rules
There's more, and it's all ugly. Shameful.W. L. Carter knew there was something fishy going on when he went to his lawyers’ office a few years ago to pick up his settlement check for the heart damage he had sustained from taking the diet drug combination fen-phen.
The check was, for starters, much smaller than he had expected. And his own lawyers threatened to retaliate against him if he ever told anyone, including his family, how much he had been paid. “You will be fined $100,000, you will go to jail and you will be sued,” Mr. Carter recalled them saying.
Mr. Carter was right to have been suspicious. The lawyers defrauded their clients, a state judge has ruled in a civil case, when they settled fen-phen lawsuits on behalf of 440 of them for $200 million but kept the bulk of the money for themselves. Legal experts said the fraud might be one of the biggest and most brazen in legal history.
This week, several clients testified before a federal grand jury that has begun to investigate potential criminal wrongdoing arising from the settlement.
“It enrages me,” said Sonja Pickett, a retail manager, who testified Thursday before the grand jury. “They robbed us.”. . .
The basic facts are not in dispute. When the clients sued the drug maker, they agreed to pay the lawyers 30 percent to 33 percent of any money that was recovered, plus expenses. In this case, that would have left the 440 clients to divide perhaps $135 million.
But the clients received only $74 million. An additional $20 million went to a questionable “charitable fund.” The rest — $106 million — went to lawyers. Though amounts of the individual settlements remain sealed, court papers suggest they were from $100,000 to $5 million. On average, plaintiffs received less than 40 percent of what the settlement agreement specified, instead of the roughly 70 percent to which they were entitled.
Had the lawyers merely taken what they were contractually entitled to, they would have become very rich men, said Tracy Curtis, a mortgage loan officer who is also suing her former lawyers. “They could have taken the high road,” Ms. Curtis said. “They would have made plenty of money.”
Federal bill prohibiting genetic discrimination analyzed by Congressional Budget Office
- Amends the Employee Retirement Income Security Act of 1974 (ERISA) and the Public Health Service Act to expand the prohibition against discrimination by group health plans and health insurance issuers in the group and individual markets on the basis of genetic information or services to prohibit: (1) enrollment and premium discrimination based on information about a request for or receipt of genetic services; and (2) requiring genetic testing. Sets forth penalties for violations.
- Amends title XVIII (Medicare) of the Social Security Act to prohibit issuers of Medicare supplemental policies from discriminating on the basis of genetic information.
- Extends medical privacy and confidentiality rules to the disclosure of genetic information.
- Makes it an unlawful employment practice for an employer, employment agency, labor organization, or training program to discriminate against an individual or deprive such individual of employment opportunities because of genetic information. Prohibits the collection and disclosure of genetic information, with certain exceptions.
- Establishes a Genetic Nondiscrimination Study Commission to review the developing science of genetics and advise Congress on the advisability of providing for a disparate impact cause of action under this Act.
For a more detailed discussion of the bill, go to H. Rept. 11-28 (Part I), March 5, 2007. Also, a number of states already have similar laws on their books. The National Conference of State Legislatures has a handy list of such laws (last updated Nov. 2006 (employment) and June 2005 (insurance)).
Yesterday, the CBO published its cost estimate for H.R. 493. Over 10 years, the federal treasury would be out about $2 million (because premiums for some of the new insureds would be tax-deductible) and the CBO estimates increased outlays of about $2 million (assuming appropriations are approved) for the Departments of Labor, Treasury, and HHS. There will be additional state and private-sector mandates in connection with the anti-discrimination law, but CBO figures the cost will be low for the states and below the threshold in the Unfunded Mandates Reform Act for the private-sector actors.
If there's a surprise in any of this, it might be in the estimated number of citizens expected to benefit from this law: 600. Is there any chance this is a typo?
Thursday, March 22, 2007
NEW MEDICARE HOSPITAL CONDITIONS OF
PARTICIPATION FOR TRANSPLANT CENTERSThe Centers for Medicare & Medicaid Services (CMS) issued a final rule today setting forth the requirements that transplant centers must meet to participate in the Medicare program that moves Medicare covered transplant programs toward an outcome-focused system.
This final rule will move Medicare-covered transplant programs toward an outcome-focused system that reflects the clinical experience, resources and commitment of the transplant program. The rule contains comprehensive conditions of participation for transplant programs serving Medicare beneficiaries.
It will ensure effective oversight of transplant centers by advancing coordination between CMS, State survey agencies, the Health Resources and Services Administration, the Organ Procurement and Transplantation Network and the Scientific Registry of Transplant Recipients.
“This is a major milestone in our efforts to make sure that people needing transplants get the best possible care, while giving transplant centers and physicians comprehensive and reliable guidance,” said Leslie V. Norwalk, CMS acting administrator. “This rule both improves the current transplant outcome measure requirements and strengthens the protection of the health and safety of patients and living donors.”
In recent decades, remarkable strides in transplantation technology and pharmacology have turned organ transplantation into a mainstream treatment for many patients in end stage organ failure. CMS issued coverage decisions related to heart transplants in 1987, liver transplants in 1991, lung transplants in 1995, and intestine transplants in 2001 and updated in 2006. Kidney transplant centers have been regulated in the Code of Federal Regulations since 1976. This rule will consolidate all transplant center requirements into one regulation.
All transplant centers that continue to participate in Medicare, including kidney transplant centers, are required to submit a request for initial approval. Once approved by Medicare, transplant centers are eligible for re-approval every 3 years.
Transplant centers with current Medicare approval, that have applied for initial approval within 180 days from the effective date of the final rule may continue to provide transplant services and receive payment from Medicare until CMS makes a decision on the transplant center’s request for approval.
The final rule went on public display today at the Office of the Federal Register for publication on Friday, March 23, 2007.
Tuesday, March 20, 2007
IRS releases "Good Governance Practices" for charitable organizations
The IRS seems to be saying that adoption of these good governance practices is not a criterion for obtaining or retaining exempt status, but that an organization that departs to a significant degree from them is more likely to engage in practices that put its exempt status in jeopardy. Interestingly, if somewhat bizarrely, the Service inserted a comment about board size into its introduction that doesn't appear -- either implicitly or explicitly -- in the Good Governance Practices themselves. It's the trite-but-true "Goldilocks" principle that boards that are too small have difficulty representing "a public interest" and boards that are too large "may be less attentive to oversight duties." Presumably boards that are "just right" are more likely to see that their duties are carried out in a manner that promotes, in the case of exempt hospitals, community benefits.
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)