HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

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Saturday, January 8, 2005

Overprescription by Design

Rx_bottles Yesterday's Washington Post had an editorial that assails the drug industry and physicians and the sometime unholy alliance forged around aggressive marketing schemes that induce docs to overprescribe medicines.  The writer notes that despite guidelines from the AMA (see Op. E-8.061 & clarification statment) and PhRMA (and, it should be added, DHHS' OIG), "the economics of the drug market make it difficult to prevent abuse. It costs billions to invent a drug but little to produce it, so there's a huge incentive to pump up sales volumes; this creates a temptation to push the ethical boundaries. Moreover, the medical market presents a classic case of informational asymmetry. Patients generally don't know enough to second-guess doctors, so doctors can get away with overprescribing medicines.  How far such overprescription occurs is hard to know."  I was geting at the same point when I reported a  week ago about some indictments out of the Eastern District of Pennsylvania.

The editorial then goes "[o]ne level up in the food chain" and criticizes "the even more disturbing [practice of] medical researchers whose opinions are likely to influence other physicians routinely accept speaking and consulting fees from the firms whose drugs they pronounce on."  [tm]

January 8, 2005 | Permalink | Comments (0)

Stem Cell News Roundup

Stem cell news from the on-line World Health News, the news digest from the Harvard School of Public Health:

  • Massachusetts: Stem Cell Bill Tops Agenda as Legislature Convenes
    Scott S. Greenberger and Frank Phillips
    (The Boston Globe, Jan. 6, 2005)
    "Democratic leaders on Beacon Hill vowed yesterday to immediately push legislation to promote stem cell research in the Bay State, hoping to blunt the appeal of California's $3 billion investment in stem cell research."
  • California: Stem Cell Glitches
    Editorial
    (San Francisco Chronicle, Jan. 5, 2005)
    "Proposition 71, the stem-cell initiative approved by voters last November, envisaged a rapid start-up of the massive $3 billion research project. But speed should not come at the expense of careful deliberation by the appointed 29-member Independent Citizens Oversight Committee as it begins to set a long-range trajectory for the initiative."
  • Harvard Biologists Criticize Compromise Plan for Stem Cell Use
    Gareth Cook
    (The Boston Globe, Jan. 4, 2005)
    "Two prominent Harvard University biologists last week criticized a potential compromise for the use of human embryonic stem cells, saying the idea -- meant to overcome ethical objections -- is scientifically 'flawed.' The proposal, called altered nuclear transfer, was presented last month to the President's Council on Bioethics by one of its members, Dr. William Hurlbut of Stanford University. The idea is to genetically engineer a human egg so that it can create embryonic stem cells without ever becoming an embryo -- potentially avoiding objections that have made the issue so politically volatile and limited federal funding of the research."  Our earlier post on this topic, with links to the transcripts of the Council's session, is here.
  • Japanese Team Succeeds in Parkinson's Stem Cell Therapy
    (Agence France Presse, Jan. 4, 2005)
    "Japanese researchers said they had successfully treated monkeys with Parkinson's disease through a stem cell transplant, potentially paving the way for an ideal remedy to the intractable disease."

[tm]

January 8, 2005 | Permalink | Comments (0)

Friday, January 7, 2005

Medicare to Cover Flu Meds

Scouring the web for something interesting to write about on a Friday afternoon, I came accross this article about how Medicare plans to offer antiviral drugs to flu sufferers on a trial basis.  I know very little about these medicines except for the fact that their effectiveness is far from proven.

However, reading the article made me think back to all the ridiculous hand-wringing that went on this past fall when it was revealed that there would be a severe shortage of flu vaccines in this country.  This was going to be a disasterous flu season, according to many, due primarily to the lack of the vaccine.  Well, I've never been too convinced that flu shots do anything at all, simply because influenza comes in many different forms and it's impossible to predict what kind of flu will eventually rear its head come flu season.  Additionally, some people claim that you can actually get the flu from the shot, but this theory has been debunked.

However, and I'll admit that my memory is only a little bit better than the media's, I have to wonder why a year in which such few shots were given is also a year in which there's been virtually no flu outbreaks.  This has to be one of the lightest flu years in recent memory.  Are we just lucky, or is the Juice Guy on to something?

[ck]

January 7, 2005 | Permalink | Comments (2)

Prescription Drugs From Canada

After finding little support in Congress for banning the purchase of cheaper prescription drugs from Canada by US consumers, the Bush administration may its wish granted by the Canadian government, CNN is reporting.  Canadian health officials have drafted a proposal which would essentially ban the sale of the drugs to the US.

Typically, a US resident wishing to buy Canadian drugs need only have their doctor fax a prescription to a Canadian doctor, who then sends another prescription to an "internet pharmacy."  Under the current proposal, the prescribing doctor on the Canadian side of the transaction would be required to actually see the patient in person before a prescription would be valid.

The article, from CNN.com, also indicates that the savings of a US consumer buying Canadian drugs has seriously eroded over the past two years. 

Other than wanting to avoid highlighting the inequities between a socialist healthcare system with our own, it's difficult to discern exactly why the Canadian government needs to pass such legislation, particularly in light of the fact that they are not dealing with any sort of supply shortages and that they are still making money off of these transactions. [ck]

January 7, 2005 | Permalink | Comments (2)

Thursday, January 6, 2005

Letting Emergency Contraception Serve Its Purpose

David Markham highlighted a recent AMA study on his blog this morning that debunks claims made by some that making emergency contraception available without a prescription increases unwanted pregnancies and sexually transmitted diseases through the indirect encouragement of sexual activity in the first place.  Not to be too crass, but NO DUH.

That's like reasoning that building a firehouse closer to a neighborhood will increase playing with matches among the residents. 

Maybe it's just me, but one would think that the term "emergency" would imply that such contraceptives would be used in situations where time is of the essence, and a prescription from a doctor certainly doesn't help to speed things along.  While I realize and accept that the underlying opposition to such drugs are wrapped up in a much larger debate, it shocks me that only SIX STATES allow emergency contraceptions to be sold directly by pharmacists to consumers.

January 6, 2005 | Permalink | Comments (0)

Stem Cell Research Can't Shrug Off Political Anchors

As you may have heard, 59% of Californians rejected the Bush Administration's stance on the government's role in stem cell research by passing Proposition 71 last fall.  The proposition created a state-funded agency which will make research grants of $3 billion over the next 10 years to institutions and universities conducting stem cell research, making California the only state, thus far, to shrug off the ethical and religious questions that caused the Bush Administration to back off of federally-funded research which involved the destruction of human embryos, including research utilizing stem cells.

However, just as stem cell advocates in that state seem to have hurdled the last obstacle in their path, other, more mundane political bumps in the road have emerged.  It seems that the committee formed by Governor Schwarzeneggar that will be deciding where the grants will be going is not conducting itself in a suitably transparent manner.  This becomes particularly disturbing in light of the fact that the steering committee members come from the same research and biotechnology institutions that sunk $28 million into the campaign to get Prop-71 passed in the first place, institutions which are likely to be the recipients of future grants.  Anyhow, one good grass roots campaign in California deserves another.

January 6, 2005 | Permalink | Comments (1)

"Single-Payor System, Anyone?"

I am not necessarily a died-in-the-wool, bred-in-the-bone single-payor advocate, but consider this: As long as we are in the fractionated system we are in now, payors will always have an incentive to avoid paying one cent more than they are contractually obligated to pay (and to litigate the close-call cases as long as they win enough coverage disputes to pay for their litigation budget).  (Not to mention the outright cost-avoidance/cost-shifting behaviors that positively harm the health of their subscribers by postponing primary and preventive care in favor of more expensive acute and chronic care, the bills for which (they are betting) will be paid often enough by someone else to make today's denials cost-effective.)

So what made me think these dark thoughts about cost-shifting and the high administrative costs of our fractionated, multi-payor system?  A couple days of audit reports from DHHS OIG, posted Jan. 4 & 5:

  • "Review of Ambulance Charges Claimed By Caritas Norwood Hospital - Fiscal Years 2002 and 2003," (A-01-04-00520)
    EXECUTIVE SUMMARY:
    The Hospital was generally in compliance with Medicare regulations for claiming ambulance services costs.  However, we identified internal control weaknesses for completing medical necessity forms and for allocating ambulance costs between Part A and Part B on the cost reports.  We recommended that the Hospital develop written policies and procedures for completing medical necessity forms including regular training of physicians and other appropriate individuals on the Medicare requirements for establishing medical necessity and establish procedures to allocate ambulance costs related to inpatient transfers to Part A inpatient services.  The Hospital agreed with and has adopted corrective actions for each of our recommendations.
  • "Review of California's Internal Controls Over Costs Claimed For Medicaid Personal Care Services," (A-09-04-00036)
    EXECUTIVE SUMMARY:
    The objective of this review was to determine if the California State Department of Health Services (State) had internal controls to ensure that costs claimed for the Medicaid Personal Care Services program for the period July 1, 2002, through June 30, 2003, were in accordance with Federal laws and regulations.  Based on our limited review, we found that the State had internal controls to ensure that costs claimed for the Medicaid Personal Care Services program were in accordance with Federal laws and regulations.  In addition, the three counties we examined had internal controls to review and authorize individual provider time sheets related to personal care services.
  • "Review of Title IV-E Training Costs in Maine for State Fiscal Years 2001 Through 2003," (A-01-03-02503)
    EXECUTIVE SUMMARY:
    The objective of this audit was to determine whether the State complied with Office of Management and Budget (OMB) Circular A-87 and Administration for Children and Families (ACF) guidance in claiming Federal reimbursement for costs for foster care and adoption assistance training.  The State did not comply with OMB Circular A-87 and ACF guidelines.  Specifically, the State (1) did not allocate perservice training costs between the Federal and State programs, (2) incorrectly calculated the Federal share of indirect costs, and (3) inaccurately reported the amount claimed for Federal reimbursement.  As a result, the State misstated Federal claims for training costs during State fiscal years 2001 through 2003.  Identified errors resulted in $4.3 million in overstatements and $1.3 million in understatements, for a net Federal overstatement of $3 million.  We recommended a financial adjustment for $3 million and procedural improvements.  The State concurred with our recommendations.
  • "Review of Medicaid Claims for Patients Under Age 21 in Private Psychiatric Hospitals That Were Institutions for Mental Diseases in California During the Period July 1, 1997, Through January 31, 2001," (A-09-02-00083)
    EXECUTIVE SUMMARY:
    The objective of this audit was to determine if controls were in place to preclude California from claiming Federal Medicaid funds for medical services, except inpatient psychiatric services, provided to residents under age 21 in private psychiatric hospitals that were institutions for mental diseases.  We found that California improperly claimed Federal funds because it did not have controls to prevent claims for medical services.  As a result, from July 1, 1997, through January 31, 2001, we estimate that California improperly claimed $310,266 ($155,133 Federal share) for such medical services.  We recommended that California (1) refund $155,133 to the Federal Government; (2) implement controls to prevent Federal funds from being claimed for such medical services; and (3) identify and refund to the Federal Government any Federal Medicaid funds improperly claimed after January 31, 2001.
  • "Review of Medicaid Claims for Patients Under Age 21 in State-Operated Psychiatric Hospitals That Were Institutions for Mental Diseases in California During the Period July 1, 1997 Through February 28, 2001," (A-09-02-00084)
    EXECUTIVE SUMMARY:
    The objective of this audit was to determine if controls were in place to preclude California from claiming Federal Medicaid funds for medical services, except inpatient psychiatric services, provided to residents under age 21 in State-operated psychiatric hospitals that were institutions for mental diseases.  We found that California improperly claimed Federal funds because it did not have controls to prevent claims for such medical services.  As a result, from July 1, 1997, through February 28, 2001, we estimate that California improperly claimed $380,920 ($190,460 Federal share) for medical services.  We recommended that California (1) refund $190,460 to the Federal Government; (2) implement controls to prevent Federal funds from being claimed for such medical services; and (3) identify and refund to the Federal Government any Federal Medicaid funds improperly claimed after February 28, 2001.

I don't for a moment begrudge the federal government's desire to limit its costs and in general act as a prudent purchaser of health care goods and services.  Ditto the private payors who act on the same instinct.  But all of this fractionated diligence comes at a cost, not least the higher-cost health care provided to the uninsured through emergency departments already drowning in a sea of red ink.  Add to that the administrative costs associated with "contract management."  When, if ever, will we decide that it would be cost-effective to (a) expand our single-payor system for seniors (a/k/a Medicare) to everyone in the country, and at the same time (b) eliminate the need for most, if not all, of the administrative costs associated with the multi-payor system?  [tm]

January 6, 2005 | Permalink | Comments (3)

Wednesday, January 5, 2005

Health Savings Accounts: Guidance from the IRS and Treasury

Here are some helpful links from the IRS' "Hot Topics" web page on the subject of Health Savings Accounts:

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 created a new, tax-advantaged way for certain people to save for health care expenses. You must be covered by a high-deductible health plan to open and contribute to a Health Savings Account (HSA). IRS and Treasury have provided guidance on how HSAs work.

Related Items:

  • Notice 2004-2 (PDF 55K) — Questions & Answers on HSAs. (Updated 8/9/04 to include changes made by Notice 2004-50, as revised.)
  • Notice 2004-50 (PDF 143K) — A set of 88 additional questions and answers on various HSA issues, including eligibility, contributions, distributions and plan administration. (Revised 8/9/04)
  • Notice 2004-23 (PDF 91K) — Safe harbors for preventive care benefits
  • Notice 2004-25 (PDF 52K) — Transition relief for medical expenses incurred in 2004 for those who establish an HSA by April 15, 2005.
  • Notice 2004-43 (PDF 50K) — Transition relief for individuals in states where high deductible health plans are not available because state laws bar or limit a deductible for certain benefits.
  • Revenue Ruling 2004-38 (PDF 55K) — HSA rules for persons covered by both a high deductible health plan and a prescription drug plan.
  • Revenue Ruling 2004-45 (PDF  85K) — Clarifies how health Flexible Spending Arrangements (FSAs) and Health Reimbursement Arrangements (HRAs) interact with Health Savings Accounts (HSAs). The guidance provides a number of ways that individuals may have access to benefits from FSAs and HRAs and remain eligible to contribute to an HSA. Issued May 11, 2004.
  • Revenue Procedure 2004-22 (PDF 38K) — Transition relief before 2006 for HSA-eligibles covered by both a high deductible health plan and a prescription drug plan.
  • Treasury Release JS-1061 — an overview of HSAs, with links to an HSA Fact Sheet and a release from the Office of Personnel Management about these accounts and the Federal Employees Health Benefits Program.
  • Treasury Release JS-1278 — a summary of additional guidance on HSAs, issued March 30, 2004

January 5, 2005 | Permalink | Comments (1)

Welcome Aboard, Chris Kuhnhein

You're off to a good start, CK!  Sometime I'd like to know how Betsy gets to travel at the beginning of the semester.  The fact that I raise this question on the evening before my first class meets should not in any way suggest sour grapes! [tm]

January 5, 2005 | Permalink | Comments (0)

Rock and a Hard Place

Just as the full extent of the problems caused by pain relievers Vioxx and Celebrex comes to light, a study by Baylor Medical School confirms a long-standing suspicion that less powerful anti-inflammatory medicines, such as ibuprofen and aspirin, may also cause serious small intestinal damage.  While it's obvious to anyone who's taken Advil or Tylenol regularly that these drugs can upset or irritate one's stomach, this study indicates that the damage may be much more serious and widespread than previously thought.

So now, doctors and patients content with avoiding the recently-revealed cardiovascular dangers of Vioxx and Celebrex must now take into account the impact of the "safer" aspirin and ibuprofen.  At some point, the FDA will need to allow arthritis sufferers to weigh the benefits of these drugs vis-a-vis their dangers and proceed accordingly, rather than banning them wholesale. 

[ck]

January 5, 2005 | Permalink | Comments (0)

De Facto Sterilization?

A family court judge in New York who caused some controversy last year by ordering a homeless mother of four to cease from having more children has ordered a drug-addicted mother of seven to do the same.  While not a widely accepted judicial practice, judges in Wisconsin and Ohio have similarly ordered "deadbeat dads" to cease from fathering children. 

Justice Douglas' 1942 majority opinion in Skinner v. Oklahoma, 316 U.S. 535, has been widely interpreted to have construed a fundamental right to "reproductive autonomy" - one of the first, if not THE first, fundamental right enunciated by the Court.  Without getting too philosophical, it was this particular right upon which the entire right to privacy framework was constructed - including, notably, the right to an abortion. 

Obviously, it's going to be tough to defend these kinds of court orders against Constitutional attacks on many different levels.  While the Skinner Court was dealing with a disturbing Oklahoma law requiring sterilization for certain kinds of criminals, isn't the family court in this case, through the threat of finding the mother in contempt, ordering de facto sterilization of the mother?  Even if this doesn't constitute sterilization in the Skinner sense, the order certainly interferes with the mother's right to procreative autonomy.  If the state is Constitutionally restricted in influencing a woman's right to have an abortion, how can an order which essentially would require a woman to have an abortion in order to avoid violating a court order be Constitutional. 

Additionally, there are Equal Protection issues about applying these orders to drug addicts and the homeless, while not applying them to those who simply don't have the competence (the mentally ill, for instance) or the economic stability (the poor) to properly care for children.  Would it be proper, for instance, if a court ordered two potential parents to not have children if it was all but certain that their child would have a genetic disease?  Or if deaf parents wanted their child to be deaf as well?

Anyway, this case provides lots of juicy debate-fodder for Constitutional jurists and scholars.  I'm sure we haven't heard the last of it.

[ck]

January 5, 2005 | Permalink | Comments (0)

Warning: Amateur Blogger

Let me start off by thanking Betsy Malloy for giving me the opportunity to post in her stead while she's travelling.  I am a third-year law student at the University of Cincinnati counting down the days until the bar exam.  My interests are pretty varied, so I think any posts that I make will probably reflect this.  My apologies in advance if any of the topics don't quite fit into the Healthcare Law category.

- Chris Kuhnhein

January 5, 2005 | Permalink | Comments (0)

Tuesday, January 4, 2005

Capitol Hill Watch: Medical Liability Reform

The Kaiser Daily Health Policy Report for January 4 does a nice job of collecting the strands of this story: the President's plan to kick-start med-mal reform during the early days of the new 109th Congress:

     President Bush on Wednesday will address more than 1,000 physicians, business leaders and Republican officials in a speech in Collinsville, Ill., aimed at "reining in lawsuits" to stem a rise in medical malpractice premiums, according to Bush spokesperson Jim Morrell, the AP/Las Vegas Sun reports (Keith, AP/Las Vegas Sun, 1/4). Bush has said he will make medical malpractice reform a priority in his second term to help spur the U.S. economy. The campaign includes three primary reforms: capping noneconomic damages in medical malpractice cases, possibly at $250,000; restricting the scope of class-action lawsuits; and limiting lawsuits against makers and sellers of asbestos-filled products. Bush is highlighting Collinsville in his campaign because the town is known for the number of lawsuits filed there (Kaiser Daily Health Policy Report, 1/3). More than 1,400 asbestos lawsuits and 179 class-action lawsuits were filed in the last two years in Madison County, which includes Collinsville. Illinois Trial Lawyers Association president Kevin Conway said that Bush is "trying to demonize one county as kind of an example of what the entire country looks like." Rep. John Shimkus (R-Ill.) said that he hoped Bush's visit to Collinsville would "keep this in the public eye," adding, "Hopefully legislators will continue to realize that this issue will not go away. He's using the bully pulpit as he should" (AP/Las Vegas Sun, 1/4).

Presidential Priority for Health Care
Bush aims to make accessibility to health care one of his priorities in the legislative session that begins Tuesday, he said Monday in a speech to new members of Congress. "I'll call upon Congress to take on big issues, and I look forward to working with members of both parties to do just that," Bush said. He added, "This town is sometimes too partisan and too political. And my hope is ... that we can show the nation that we can come together to achieve big things for the good of the country" (Pickler, AP/Las Vegas Sun, 1/3).

Editorials
Two recent editorials addressed health policy developments. Summaries are provided below.

New York Times: Improving quality in the U.S. health care system "may be a little lower on the agenda," but the "potential bridges between [both] parties are already clear and sturdy," a Times editorial states. "Pressing ahead on this front should be a no-brainer -- if the Democrats can allow the Republican majority to take most of the credit, and the Republicans can control their urge to bring the poison pill of malpractice tort reform into the discussion," according to the editorial (New York Times, 12/31/04).

Wall Street Journal (requires fee-based subscription): So-called specialty hospitals are "one of the more encouraging new areas of health competition," and elected officials should keep "their hands off" them to encourage market-oriented health care reform, a Journal editorial states. "Hospitals that concentrate on targeted areas," such as cardiac, orthopedic and women's medicine, "can provide superior services at the lower costs that come with efficiencies," the editorial continues. Although Republican legislators have "taken some baby steps" toward adding market-based elements, such as health savings accounts, to the health care system, they must continue to ensure that "consumers have a choice of places to spend those dollars, which means competition among hospitals," according to the editorial (Wall Street Journal, 1/3).

January 4, 2005 | Permalink | Comments (0)

New Cloning Article

If you are looking for something interesting to read, (and to be honest, after grading first year exams, who isn't searching for something more coherent and interesting to read) Steven Goldberg of Georgetown University  Law Center has recently published, "Cloning Matters:  How Lawrence v. Texas Protects Therapeutic Research, in the Yale Journal of Health Policy, Law and Ethics.  The abstract is posted below:

Abstract:     
Several states have banned therapeutic cloning and the federal government is considering legislation that would do the same. Some of these laws, including the proposed federal law, make it a crime for a patient to use any product derived from therapeutic cloning. Government action restricting a patient's freedom in this way must at least have a rational basis. Opponents of therapeutic cloning argue not that the medicines derived from it are unsafe or ineffective, but rather that the embryonic stem cells used in therapeutic cloning represent potential life that must be protected. Yet some spare embryos produced as a byproduct of fertility treatments are destroyed while others are used for research. This disparate treatment reveals that the real basis for the ban on therapeutic cloning is a repugnance at cloning, a sense that it is unnatural. The Supreme Court's recent decision in Lawrence v. Texas, as well as earlier precedent, casts serious doubt on the idea that repugnance can be an adequate basis for a criminal statute. 

[bm]

January 4, 2005 | Permalink | Comments (2)

AALS Conference Offerings

For those of you headed for the AALS Annual Meeting, here are some of the interesting health-related panels being offered:

Autonomy Suspended:  The Use of Patients for Teaching Purposes Without Their Knowledge or Consent  (papers to be published in the Journal of Health Care Law and Policy).  Friday, January 7th:  8:30-10:15am.

Assisted Reproduction, Parentage and Inheritance in the 21st Century

Friday, January 7th,:  4:00-5:45pm.

Teaching Mental Disability Law Across the Curriculum

Saturday, January 8th; 1:30-3:15pm.

The Definition of Disability in the Americans with Disabilities Act:  Its Successes and Shortcomings

Saturday, January 8th, 3:30pm-5:15pm.

I hope that everyone has a safe trip and enjoys the various presentations. [bm]

January 4, 2005 | Permalink | Comments (0)

Monday, January 3, 2005

Children and Prescription Drugs

The New Yorker has an excellent article on children and prescription drugs.  Jerome Groopman talks about the dangers involved in prescribing medications tested only on adults to children.  There is also an extra question and answer session with Jerome Groopman.  Both are an interesting read and available on-line for free.  Although I do recommend buying a copy so you also get the cartoons.  [bm]

January 3, 2005 | Permalink | Comments (0)

Health Facts for 2004

The American Medical News reports on the most intriguing health facts of 2004.  A few interesting facts:

Only 38% of healthcare workers receive a flu shot.

By age 25, half of sexually active young people will acquire a STD. 

Nearly one-third of all adults are obese.

Bone density is a better predictor of longevity than cholestoral level.

16.5 million American women do not have health insurance.

[bm]

January 3, 2005 | Permalink | Comments (0)

5th Cir.: M+C Claims by Contracted Providers Not Subject to Exhaustion Requirement

After a series of District Court opinions to the contrary, the Fifth Circuit has restored sanity to the law of Medicare+Choice (renamed "Medicare Advantage") litigation.  Here's the type of problem addressed by the Rencare decision, handed down Dec. 31:

Hospitals contracted with managed care organizations (MCO) to provide discounted services to Medicare beneficiaries who selected the M+C option.  The hospitals provided various services and claimed they were either paid late or not at all by the MCOs, which had already received their payments from the Medicare program.  The hospitals sued in state court for breach of contract and/or breach of the prompt-pay statute (if any) in their state.  The MCO removed to federal court (on the theory that these are, at bottom, payment disputes that arise under the Medicare statute) and then moved to dismiss because the hospitals haven't exhausted their administrative remedy with CMS.  A number of district courts have been seduced by this argument and have granted the motion to dismiss.

The Fifth Circuit's short and unanimous opinion deftly brushes aside the exhaustion argument, primarily on the ground that there is no administrative remedy to exhaust when you are a contracted provider trying to get paid for services already approved by CMS and for which the government has already paid the MCO.  The court is especially solid in distinguishing the Supreme Court's Ringer decision (in which the Court upheld the exhaustion requirement based upon its observation that a challenge to HCFA's coverage decision was "inextricably intertwined" with straight-up Medicare reimbursement claims, which were unarguably subject to the exhaustion requirement).  Lots of courts have misread Ringer and applied it to situations to which it doesn't apply, and the 5th Circuit in Rencare has finally put Ringer in its place.

January 3, 2005 | Permalink | Comments (0)

Jury Selection Set to Begin in HealthSouth Trial

Healthsouth It's not exactly "O.J." or the Scott Peterson murder case, but one of the highest of high-profile U.S. Attorneys (Alice Martin) begins jury selection today in the fraud case against the flamboyant former HealthSouth CEO, Richard Scrushy.  Scrushy is alleged to have overstated profits of the rehab system by nearly $3 billion, resulting in a "58-count indictment accusing him of fraud, conspiracy, perjury, obstruction of justice and violating the Sarbanes-Oxley law, which requires top executives to certify the accuracy of their company's financial statements."  (AP, courtesy of The Washington Post.[tm]

January 3, 2005 | Permalink | Comments (0)

Ohio Supreme Court Rules in PVS Case

Building Aiden Stein was taken into the hospital at the age of 5 months with massive brain damage and other injuries suggestive of child abuse.  His father, who was alone with Aiden at the time of Aiden's injuries, could be charged with murder, and Aiden's mother remains engaged to the father.  Because Aiden is permanently unconscious, his physicians recommended that he be taken off life support, a recommendation that was also supported by the hospital ethics committee.  The ethics committee also recommended appointment of a guardian to make Aiden's medical decisions, because both of his parents had a substantial conflict of interest due to the serious criminal charges that could result from Aiden's death.  The trial court appointed a local nurse-attorney as the child's guardian for the limited purpose of making medical decisions, including decisions about life-supporting treatments.

Last Thursday, a unanimous Ohio Supreme Court ruled that a guardian could be given the power to make life-and-death decisions only if the parental rights of the child's parents had been terminated, which has not happened.  The court's reason, in brief, can be gleaned from these excerpts:

“The fundamental liberty interest of natural parents in the care, custody, and management of their child does not evaporate simply because they have not been model parents or have lost temporary custody of their child to the State. Even when blood relationships are strained, parents retain a vital interest in
preventing the irretrievable destruction of their family life. If anything, persons
faced with forced dissolution of their parental rights have a more critical need for procedural protections than do those resisting state intervention into ongoing family affairs. When the State moves to destroy weakened familial bonds, it must provide the parents with fundamentally fair procedures.” Santosky v. Kramer (1982), 455 U.S. 745, 753-754, 102 S.Ct. 1388, 71 L.Ed.2d 599.

We conclude that the probate court’s order authorizing the guardian to withdraw life-supporting treatments has the effect of terminating parental rights. We, therefore, hold that the probate court exceeded its statutory authority in granting the guardian the power to withdraw life-supporting treatments before the parents’ rights were permanently terminated. . . .

The heartbreak and tragedy in this case cannot be overstated.  However, we believe that without a full and proper adjudication of parental rights concluding in a termination of those rights, a probate court has no authority to allow a guardian to make a decision that will terminate the life of a child, when parental rights have not been permanently terminated, thereby terminating the parent-child relationship. . . .

The case is In re Guardianship of Stein, __ Ohio St.3d __, 2004-Ohio-7114 (Dec. 30, 2004) (PDF).  Although formally a statutory interpretation case, the citation to the U.S. Supreme Court clearly demonstrates the Ohio court's belief that a narrow statutory interpretation was needed to avoid an unconstitutional result.  Thus, the implications of this decision go well beyond the court's reading of the Ohio guardianship law. 

The result reached by the court is also at odds with standard practice in many states when dealing with parents who cannot or will not participate meaningfully in end-of-life decision making.  Temporary and limited guardianships are frequently ordered by local courts for the sole purpose of making medical decisions for the incompetent patient, without going through a full-blown termination-of-parental-rights process.  The Ohio Supreme Court's opinion suggests that -- whatever the statutory issues may be in another state -- empowering a guardian to make a decision to withdraw or withhold life-sustaining treatment without first terminating the parents' rights violates the federal constitution. [tm]

January 3, 2005 | Permalink | Comments (0)