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
Sunday, December 02, 2007
New York City Law Review Issues Call for Papers on Health Care
The Symposium will look at two critical questions: (1) Can international human rights frameworks help the United States overcome obstacles to universal coverage? and (2) Can innovative litigation expand coverage to vulnerable populations? Given that the 2008 general election has already placed health care as a central campaign theme, now is a critical time to evaluate the practical litigation and policy models for providing access to the uninsured and vulnerable populations, says Matthew Monroe, one of the symposium's organizers. For more details on the symposium and how to make topic submissions, visit: http://www.nyclawreview.org/
AHLA Health Lawyers Weekly, Nov. 30
Top Stories
- OIG Takes Back Power To Investigate Employee Criminal Conduct From FDA -- The Department of Health and Human Services Office of Inspector General (OIG) will no longer share responsibility with the Food and Drug Administration (FDA) for investigating potential criminal misconduct by FDA employees, Inspector General Daniel Levinson said in a September letter to FDA Commissioner Andrew C. von Eschenbach. Full Story
- CMS Releases List Of 54 Worst Performing Nursing Homes -- The Centers for Medicare and Medicaid Services (CMS) has released the first ever list of the nation's 54 poorest performing nursing homes, the agency said in a November 29 press release. Full Story
Articles & Analyses
- Illinois Hospitals Face Conflicting Requirements Regarding Nurse Staffing, by Janice A. Anderson and Anne M. Cooper, Foley & Lardner LLP
Current Topics
- Antitrust
[1] AHA Presses DOJ To Block Health Plan Merger
[2] FTC Reaches Settlement With Barr Involving Oral Contraceptive Drug- Arbitration/Mediation
California Appeals Court Finds Nursing Home Arbitration Agreements Invalid- Criminal Law
Prominent Plaintiffs’ Attorney Indicted For Attempting To Bribe Judge- EMTALA
U.S. Court In Indiana Finds Plaintiff Alleging EMTALA Violations Cannot Amend Complaint To Seek Damages Under § 1983- Fraud and Abuse
Michigan Appeals Court Reverses Dismissal, Remands Medicaid Fraud Case For Trial- Update
- Healthcare Access
[1] CMS Approves Wisconsin’s Plan To Expand Eligibility For Its SCHIP Program
[2] Hospitals Face Increasing Challenges In Obtaining Emergency On-Call Coverage From Specialists, Study Says- Hospitals and Health Systems
Florida Appeals Court Upholds State Agency’s Decisions Allowing Hospitals To Recover Payments From Workers’ Compensation Carriers- Managed Care
[1] Health Net Fined $1 Million For Failing To Disclose Compensation Based On Plan Rescission
[2] NY Physician Ranking Model To Become State Law- Medicaid
U.S. Court In Delaware Holds State’s Residency Requirement For Medicaid
Eligibility Violated Constitutional Right To Travel- Medical Malpractice
[1] Washington Appeals Court Holds Malpractice Plaintiff May Not Rest Informed Consent Claim On Evidence Of Physician’s Inexperience
[2] Georgia Appeals Court Finds No Right To Indemnity Where Liability To Pay Judgment Not Compulsory
[3] Florida Appeals Court Finds Medical Malpractice Plaintiff Presented Sufficient Expert Testimony To Proceed To Trial
[4] Iowa Appeals Court Remands Medical Malpractice Case For New Trial, Finding Abuse of Discretion In Lower Court’s Rulings- Medicare
[1] Lawsuit Seeks Medicare Part D Coverage Of Drugs For Medically Necessary Off-Label Uses
[2] Medicare Continues To Reduce Improper Claims Payments, CMS Says
Eighth Circuit Rejects MSP Action By Individual Claiming Standing As Qui Tam Relator
[3] CMS Issues Report To Congress On Medicare Hospital Value-Based Purchasing- News in Brief
GlaxoSmithKline Agrees To $1.4 Million Settlement With Texas- Patient Safety
Massachusetts Hospitals Will Not Charge For Adverse Events- Physicians
[1] Washington Appeals Court Affirms Sanctions Against Physician For Unprofessional Conduct
[2] U.S. Court In Washington Finds Hospital Did Not Violate Physician’s Civil Rights In Denying Application For Privileges
Informed consent & SCOTUS: A tale of two doctrines
JESSIE HILL
Case Western Reserve University - School of Law
Texas Law Review, Vol. 86, No. 2, December 2007
Case Legal Studies Research Paper No. 07-28
Abstract:
Top Ten Health Law Stories in 2008: FDA
The nation’s food supply is at risk, its drugs are potentially dangerous and its citizens’ lives are at stake because the Food and Drug Administration is desperately short of money and poorly organized, according to an alarming report by agency advisers.
- The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.
- FDA does not have the capacity to ensure the safety of food for the nation.
- The development of medical products based on “new science” cannot be adequately regulated by the FDA.
- There is insufficient capacity in modeling, risk assessment and analysis.
- FDA science agenda lacks a coherent structure and vision, as well as effective coordination and prioritization.
- The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.
- The FDA has substantial recruitment and retention challenges.
- The FDA has an inadequate and ineffective program for scientist performance.
- The FDA has inadequate funding for professional development.
- The FDA has not taken sufficient advantage of external and internal collaborations.
- The FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate.
- The Subcommittee believes that there is evidence of important, but slow, progress to improve information sciences and technology at the FDA over the past few years, yet significant gaps remain.
- The FDA lacks the information science capability and information infrastructure to fulfill its regulatory mandate.
- The FDA cannot provide the information infrastructure support to regulate products based on new science.
- The FDA IT infrastructure is obsolete, unstable, and lacks sufficient controls to ensure continuity of operations or to provide effective disaster recovery services.
- The IT workforce is insufficient and suboptimally organized.
If that's not enough to make your Post Toasties wilt, I don't what is . . . .
Friday, November 30, 2007
WSJ: Health policy caps mean catastrophic coverage may not be there when needed
Yesterday's WSJ ran a story that highlights the plight of the insured middle-class in this country: It's possible to max out a health policy with a $1.5 million cap in the metaphorical blink of an eye. The story is here (though it may require a paid subscription to read it).
Tuesday, November 27, 2007
When hospice patients don't die quickly enough, Medicare comes knocking
Friday, November 09, 2007
Krugman: Health Care Excuses
- Excuse No. 1: No insurance, no problem.
- Excuse No. 2: It’s the cheeseburgers.
- Excuse No. 3: 2007 is better than 1950.
- Excuse No. 4: Socialized medicine! Socialized medicine!
And, by the way, a big shout out to the managers at The New York Times who have stopped putting the good stuff where only subscribers could get to it. I don't know what their new business plan is, or how they can afford it, but I am grateful for total Web access (i.e., the same as The Washington Post). As a subscriber, I've always had it, but as a blogger it was frustrating not being able to share so much as a link. Those days are now blissfully over!
Insurer misconduct alleged in California
Calif. insurance chief probes report of cancellations
California’s insurance commissioner is investigating a report that Health Net rewarded an analyst more than $20,000 in bonuses tied to canceling individual health insurance policies, thereby saving the company millions in medical expenses.
“We certainly view this as a serious breach,” said Byron Tucker, spokesman for state Insurance Commissioner Steve Poizner.
The Los Angeles Times reported that Health Net revoked 1,600 policies between 2000 and 2005, saving the Woodland Hills, Calif.-based insurer $35.5 million in medical payments. The company set policy rescission targets, which the senior analyst in charge of cancellations regularly exceeded, earning her praise and monetary rewards, according to the newspaper.
Tying compensation of claims reviewers to their actions is illegal under state law.
“The characterization of our compensation programs is inaccurate and misleading,” Health Net said in a written statement.
The bonuses were disclosed during an arbitration hearing on a $6 million lawsuit brought by a 51-year-old hairdresser from the Los Angeles area whose Health Net policy was revoked during her chemotherapy treatments for breast cancer. The Times’ lawyers intervened to have the documents unsealed, according to the newspaper.
Thursday, October 25, 2007
Deputies seize baby to test blood against parents' will
Sunday, October 21, 2007
Iglehart on the House's failure to override Bush's SCHIP veto
Saturday, October 20, 2007
Federeal employees' health plan not much of a model for reform
Thursday, October 04, 2007
Major-party presidential candidates on health reform
Tuesday, October 02, 2007
SCHIP
White House to face state SCHIP lawsuits -- New Jersey was the first of several states expected to file lawsuits against the Bush administration over rules set in August that limit state coverage of children's health insurance to exclude children in middle-income families. Arizona, California, Illinois, Maryland, New Hampshire, New York and Washington also say they plan to file or support lawsuits challenging the rules, claiming that the income limits set by the administration breach federal government authority on SCHIP and make it more difficult for them to provide coverage for children. "Our chief goal with SCHIP is to ensure that the poorest kids and those with no health insurance are placed at the front of the line," a CMS spokesman countered. Courier-Post (Camden-Cherry Hill, N.J.) (10/2), The Washington Post (10/2), Forbes/Associated Press (10/1).
Interesting development, this. This issue of whether higher eligibility cutoffs for SCHIP will put on the federal dole middle-class kids who would otherwise be covered by private insurance is at the heart of the White House's veto of the new SCHIP authorization bill (H.R. 976), too. Terence Hunt is reporting (AP/Washington Post) this afternoon that Pres. Bush has announced his intention to veto the SCHIP reauthorization bill on Wednesday, and that there will be no ceremony for the television cameras. Too bad: I was hoping to be able to post the YouTube video of the veto ceremony. Guess I'll have to go with something else . . . .
Sen. Susan Collins (R-Me.)
Friday, September 28, 2007
FDA's oversight of human-subject research: slim to none
Sunday, September 16, 2007
Health Lawyers Weekly, September 14
Top Stories
- CMS Denies New York’s Plan For Expanding SCHIP, Opposition To New Policy Mounts
- Aventis Pays Over $190 Million To Settle FCA Claims Alleging Fraudulent Drug Pricing And Marketing Practices
Current Topics include Antitrust, Business Transactions, Fraud and Abuse, Healthcare Access, Healthcare Spending, Hospitals and Health Systems, Insurance, Managed Care, Medical Malpractice, Medicare, Physicians, and Tax.
Vatican reaffirms stance on obligatory nature of ANH
This is from the recently posted "Responses to Certain Questions of the United States Confernce of Catholic Bishops Concerning Artificial Nutrition and Hydration," issues by the Congregation for the Doctrine of the Faith and, as if it needed to be said, "The Supreme Pontiff Benedict XVI, at the Audience granted to the undersigned Cardinal Prefect of the Congregation for the Doctrine of the Faith, approved these Responses, adopted in the Ordinary Session of the Congregation, and ordered their publication." The English translation is here, and the official commentary is here.
The big questions now are what will be the effect of these statements on health care decisions by Catholics and on the policies of Catholic healthcare institutions.
Insuring the uninsured: the right thing to do, but what's in it for me?
In short, altruism has its limits, as does the public’s appetite for trade-offs in their own lives for the sake of the uninsured, said Bill McInturff, a Republican pollster who worked for the insurance industry in 1993 and 1994. “Never, in my years of work, have I found someone who said, ‘I will reduce the quality of the health care I get so that all Americans can get something,’ ” he said. “Every time the debate reaches that point, it collapses.”
This time, candidates are emphasizing the benefits for people who already have insurance — lower costs for coverage, new programs to improve the quality of health care. “Everyone has to feel, at the end of the day, that they will get something,” said one Clinton adviser.
Expanding coverage to the forty-seven million Americans who now lack health insurance could greatly improve care for people who already are protected. Economists Mark Pauly of Wharton and José Pagán of the University of Texas-Pan American found that insured adults who live in communities with high uninsurance rates are more likely to face problems with access to care and quality than those who live in communities where more people are covered.
Thursday, August 30, 2007
Drake Law School looking for health law/insurance law teacher
DRAKE LAW SCHOOL seeks applications for a tenure-track position in the area of health law, insurance law and related fields commencing in the 2008-09 academic year. We are interested in both entry-level and experienced candidates with a J.D. degree and strong academic credentials who exhibit the ability to produce excellent scholarship and become outstanding teachers. Applicants who will contribute to the diversity of the faculty are particularly encouraged to apply. Drake University is an equal opportunity employer and actively seeks applicants who reflect the diversity of the nation. No applicant shall be discriminated against on the basis of race, color, national origin, creed, religion, age, disability, sex, gender identity, sexual orientation or veteran status.
Contact: Professor Cathy Lesser Mansfield, Chair, Faculty Recruitment Committee, Drake Law School, 2507 University Ave., Des Moines, IA 50311 or e-mail: cathy.mansfield@drake.edu.
Monday, August 27, 2007
Medicare beneficiaries lag in taking advantage of covered screenings and preventive care
CMS says Medicare is spending more on prevention efforts. The Wall Street Journal (8/26, McQueen) reported, "Medicare, the federal health-insurance program for older Americans, increasingly is paying for screening tests and immunizations that previously were not covered. But the vast majority of recipients are failing to take advantage, officials say." Less than 10 percent of Medicare recipients are "getting all the screenings and immunizations recommended by public health groups," according to the CMS. And, just over "a third of recipients didn't get a free flu shot in 2005, for example, even though elderly and immune-system-compromised patients are at high risk of death from the disease." In order to reverse this trend, "Medicare officials launched a bus tour of 48 states and more than 120 cities this summer, in conjunction with local officials, hospitals and elder-care groups. The tour is expected to wrap up this week." The Journal noted, "Until now, just five percent of Medicare spending has been for preventive services, officials say. But in recent years, as medical evidence has mounted about the cost-effectiveness of preventing diseases such as flu, diabetes and heart disease instead of treating them later, the U.S. has authorized more spending on screening tests and immunization."This caught my eye for a couple of reasons. First, it is scandalous that Medicare beneficiaries aren't getting the preventive services they need to fend off really serious and expensive health problems. Of course, the reason might be that the elderly haven't gotten the word about changes in Medicare coverage for such items. But it might also be because of other impediments such as limited transportation, the extra burden from multiplying trips to providers of different kinds to get the screenings done, etc. But at least CMS is focusing on the easiest-to-solve part of the problem by trying to do a better job of getting the word out.
Second is the statement that "medical evidence has mounted about the cost-effectiveness of preventing diseases such as flu, diabetes and heart disease instead of treating them later." This is certainly conventional wisdom, and this argument has an undeniable, intuitive appeal. But is it true?
There is evidence to support the proposition, at least within a limited time frame and for certain medical conditions and certainly for the individual who, as a result of the screening or the flu shot, didn't get sick. For example, as the New York Times reported [TimesSelect article: no link available] on January 11, 2006, in an article about diabetes prevention:
But what if avoiding the life-threatening acute medical condition simply permitted a large percentage of patients to survive for a life-time of care for their chronic conditions. Isn't it at least possible that the cost savings would eventually be exceeded by the costs associated with a longer life-time of care? That seems to have been the thrust of a March 16, 1997, article in the Times [also TimesSelect (no link)]:Insurers, for example, will often refuse to pay $150 for a diabetic to see a podiatrist, who can help prevent foot ailments associated with the disease. Nearly all of them, though, cover amputations, which typically cost more than $30,000.
Patients have trouble securing a reimbursement for a $75 visit to the nutritionist who counsels them on controlling their diabetes. Insurers do not balk, however, at paying $315 for a single session of dialysis, which treats one of the disease's serious complications.
While studies have shown that preventive care is generally good for your health, they have also shown that it often does not save money.
The central problem is that the early detection of many diseases, like high cholesterol and H.I.V. infection, is often followed by a lifetime of costly treatments and drugs. Expensive hospitalizations may only be forestalled. So in many cases, total medical costs actually rise.
''An awful lot of preventive care has no payoff economically -- it actually costs money,'' said Uwe Reinhardt, a health economist at Princeton University. ''If the [managed care] plans are doing it, they're doing it because they think it gives them a good image. A lot of this stuff is overhyped.''
That's the message, again, from the recent essay by David Leonhardt, "Free Lunch on Health? Think Again" (NY Times, Aug. 6, 2007; TimesSelect [no link]). Leonhardt notes that Rudy Giuliani and the three leading Democratic presidential candidates (Clinton, Edwards, Obama) are all promoting the idea that
[b]y practicing preventive medicine, doctors can keep many people from getting sick in the first place. Those who do end up with a chronic illness will be closely tracked so that fewer of them develop complications. These steps will result in less illness, which in turn will require less health care. With the savings, the country can then lower its medical bills or provide health insurance for the 40-odd million people who lack it -- or maybe even both.
As Hillary Clinton recently told The Atlantic, it's possible to ''save money
and improve quality and cover everybody.''
The hitch, according to Leonhardt, is that
[n]o one really knows whether preventive medicine will save money in the long run, let alone free up the billions of dollars a year needed to help pay for universal health insurance. In fact, studies have shown that preventive care -- be it cancer screening, smoking cessation or plain old checkups -- usually ends up costing money. It makes people healthier, but it's not free.
''It's a nice thing to think, and it seems like it should be true, but I don't know of any evidence that preventive care actually saves money,'' said Jonathan Gruber, an M.I.T. economist who helped design the universal-coverage plan in Massachusetts.
This is a tough idea to swallow because better health really does seem as if it should lead to lower medical bills. Indeed, if it were somehow possible to wave a wand and turn people into thin nonsmokers who remembered to take their statins, this country's health care expenses would fall.
But any effort to promote health has its own costs. Doctors and nurses need to spend time with patients to persuade them to change their behavior. (Ever tried to get someone to stop smoking or drinking?) For a new program to work, it has to reach people who are not being helped by whatever exists now -- and who thus will be among the most difficult and expensive patients to treat. The program would also have to treat a whole lot of people who never would have gotten sick.
Jay Bhattacharya, a doctor and economist at Stanford's School of Medicine, estimates that to prevent one new case of diabetes, an antiobesity program must treat five people -- ''not cheaply,'' he says. Along the same lines, Mr. Gruber found that when retirees in California began visiting their doctor less often and filling fewer prescriptions, overall medical spending fell. People did get sick more often, but treating their illnesses was still less costly than widespread basic care -- in the form of doctors visits and drugs. Louise Russell, an economist at Rutgers, points out that programs that focus on at-risk patients cost the least, but even they are rarely free.
As Dr. Mark R. Chassin, a former New York state health commissioner, says, preventive care ''reduces costs, yes, for the individual who didn't get sick.''
"But that savings is overwhelmed by the cost of continuously treating everybody else.''
The actual savings are also not as large as might at first seem. Even if you don't develop diabetes, your lifetime medical costs won't drop to zero. You might live longer and better and yet still ultimately run up almost as big a lifetime medical bill, because you'll eventually have other problems. That would be an undeniably better outcome, but it wouldn't produce a financial windfall for society.
Certainly, there are examples of preventive care that can save money. As Mrs. Clinton has noted, Safeway and a handful of other companies have held down health costs by emphasizing prevention. (This, of course, is only over the short term.) Perhaps the best examples fall under the category of what Dr. Brent C. James calls 'do it right the first time.''
Dr. James is an executive at Intermountain Healthcare, a network of hospitals in Utah and Idaho that has saved money in recent years by reducing hospital infections and drug errors. Intermountain hospitals have also largely stopped inducing child labor for the sake of doctors' or parents' convenience. The hospital induces birth only for medical reasons -- and the number of babies that spend time in the neonatal intensive care unit has fallen.
It's this last example that holds the real key to cutting medical costs. I realize many
people will react to the notion that preventive care usually costs money by saying, ''So what? We should do it anyway.'' And we should.But by describing it as an easy win-win solution, the presidential candidates are gliding over an important part of the issue. Preventive care saves real money only when it replaces existing care that is expensive and doesn't do much, if any, good. There are plenty of examples of such care -- from induced labor to many lumbar surgeries and cardiac stent procedures.
The problem is that the people getting this care typically don't consider it wasteful. We all like to believe that other people are the ones getting the unnecessary care. We, on the other hand, are probably not getting enough treatment.
Persuading people otherwise -- persuading them that basic care is sometimes cheaper and better -- will be difficult. Sometimes insurance plans will simply have to say no to questionable care, over the opposition of doctors' groups with a financial interest in the status quo. But it's the only way to ''save money and improve quality and cover everybody,'' as Mrs. Clinton says.
This is one of the best articles I've seen in the popular press that explores some of the variables in the "pay for increased coverage by increasing cost-effective primary and preventive care" argument. The problem is -- should we be surprised? -- much subtler and more difficult than our political candidates are making it sound.