HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

A Member of the Law Professor Blogs Network

Saturday, December 18, 2004

Too much vaccine

The American people have proven themselves to be overly generous during this flu season.  The CDC reported last week that many states had a surplus supply of the flu vaccine.  Concerns exist that too many people have decided to forego the vaccine, including those who are in the high risks groups.   A new recommendation has been issued that encourages those 50 and older to get the flu vaccine.

[BM

December 18, 2004 | Permalink | Comments (0)

Seniors Support Legalizing Medicinal Marijuana

AARP's polling data show that nearly three-fourths of senior citizens think a patient should be able to lawfully obtain cannabis if a doctor recommends it, according to an AP story filed today.  Meanwhile, the Supreme Court -- where the average age of the Justices is 70.2 years (well above the minimum age for AARP membership) -- held oral argument in the medical marijuana case (Ashcroft v. Raich, No. 03-1454) on Nov. 29.  The Court posted the transcript to its web site earlier this week.  Marty Lederman's same-day assessment of the case over on Scotusblog predicted a 9-0 victory for the feds, but Marty didn't have the benefit of AARP's polling data, which suggest that 6 of the 9 Justices support the legalization of medical marijuana . . . [tm]

December 18, 2004 | Permalink | Comments (0)

Med Mal Claims and the Power of Apology

Contrary to the teachings of a generation of trial attorneys, apologizing for medical errors may reduce claims.  If the University of Michigan's experience is a guide, it also reduces the time that elapses between the opening and closing of a malpractice claims file, presumably reducing costs along the way.  And it can be good for the soul of the institution and the provider whose mistake caused harm to a patient. 

Today's Weekend Edition Saturday on NPR broadcast an interesting discussion of these issues between host Scott Simon and Rick Boothman, a trial attorney for the University of Michigan.  The audio file will be available by 1:00 p.m. EST today.

We earlier posted a comment (Nov. 30) about a Washington Post story that examined a Maryland proposal that would make apologies by health care providers inadmissible at trial.  In today's interview, Boothman said U of M seeks no waivers or releases in connection with their apologies.  If we've made a mistake and caused harm, he said, we should be about getting right with the patient, not trying to beat a liability claim, although U of M's experience seems to be that unconditional apologies do reduce the incidence and severity of malpractice claims.  [tm]

December 18, 2004 | Permalink | Comments (0)

Friday, December 17, 2004

FDA: Crisis in Confidence?

Fda As reported by the AP yesterday (courtesy of Yahoo!News),

About two-thirds of Food and Drug Administration scientists are less than fully confident in the agency's monitoring of the safety of prescription drugs now being sold, according to an FDA internal survey.

Also, more than one-third of those scientists have some doubts about the process for approving new drugs, the survey found.

The survey was conducted by the Health and Human Services' Office of Inspector General. Complete results were released to the public only after an advocacy group filed a Freedom of Information Act request. The release comes in the wake of safety concerns forcing removal from the market of Vioxx, an arthritis drug, and congressional testimony by an FDA scientist, Dr. David Graham, that the agency mishandled safety concerns about five other drugs.

"By all appearances, FDA would rather be sorry than safe," said Rebecca Roose, director of the Public Employees for Environmental Responsibility, which obtained the survey through the FOIA request. "These results show that many of Dr. Graham's colleagues share his concerns, but that those warnings are falling on deaf ears."

An agency spokesman, Brad Stone, said the survey was commissioned in 2001 and was two years old. He said the survey confirmed that FDA medical reviewers believe the drug decisions "appropriately assess the safety and effectiveness of drugs and the process allows for open in-depth scientific debate."

[tm]

December 17, 2004 | Permalink | Comments (1)

New Article on Protecting Patient Dignity

Using Tort Law to Secure Patient Dignity Journal of the Association of Trial Lawyers of America Vol. 42, pp. 42-51, October 2004,

Authors:  JOHN DUNCAN; Independent; DAN LUGINBILL; Ness, Jett & Tanner, LLC; MATTHEW RICHARDSON; Wyche, Burgess, Freeman & Parham, PA;Collumbia, PA Office; ROBIN WILSON, Universiity of Maryland School of Law

The practice of using anesthetized patients to teach pelvic exams on female patients in university hospitals has been well documented for years. A 1992 study showed that 37 percent of U.S. and Canadian medical schools allowed students to use anesthetized women without their consent to learn how to perform pelvic exams. Anecdotal accounts in the U.S. confirm that men are not immune from such indignities. Although patients have been unable, thus, far to enforce their own interests and protect their dignity, the tort system may yet succeed in securing the right of patients to decide who touches their bodies and under what circumstances.

Using tort law to secure patient dignity examines the theories of recovery available to those who have been the subject of unauthorized teaching exams. It evaluates a patient's likely success under theories of medical battery and malpractice, failure to obtain informed consent, and breach of fiduciary duty. It explores the obstacles to recovery and the arguments that will be raised by physicians and teaching hospitals in defense of this practice, and concludes that the tort system may be the most effective vehicle to redress the unauthorized use of patients' bodies as teaching tools and to curb this practice.

The full article is available here.

[BM]

December 17, 2004 | Permalink | Comments (0)

MedMal Courts

A recent National Law Journal article reports that several states are considering the creation of medical malpractice courts as part of an overall tort/medical malpracctice reform package.   Currently four states, Illinois, Maryland, Massachusetts, and Pennsylvania are debating the creation of such courts and as many as ten other states have expressed some interest in the courts.

Although not much information is available about these courts, the National Law Journal states that "the courts would likely be designed to eliminate juries and allow a judge with medical expertise to decide cases, possibly with the help of court-appointed experts."  Those who support the courts argue for the increased efficiency and effectiveness that would allegedly result.   Those who opposed the medmal courts argue that such courts deny individuals the constitutional right to a trial by jury. 

[BM]

December 17, 2004 | Permalink | Comments (0)

Hey, Buddy. Wanna Power Wheelchair Cheap?

Tdx5 CMS got whacked a couple of times this week over its handling of Medicare fraud in connection with power wheelchairs.  First, as reported here previously, DHHS' Office of Inspector General recently issued its semi-annual report to Congress, in which it touted its vigilence in dealing with the emerging issue of power wheelchair fraud and gently prodded the CMS to do more to curb abuses:

OIG published two related inspections on Medicare’s reimbursement for wheelchairs. One report found that the program paid significantly higher rates for power wheelchairs compared with suppliers and consumers.  The second report, an analysis of power wheelchair reimbursement, found that Medicare is spending an estimated $178 million for wheelchairs that do not meet Medicare’s coverage criteria. OIG recommended that CMS take steps to improve compliance with Medicare’s coverage criteria for power wheelchairs.

GAO was a bit more pointed in its report, "CMS’s Program Safeguards Did Not Deter Growth in Spending for Power Wheelchairs," GAO-05-43 (Nov. 2004), released Dec. 15:

Over a 6-year period beginning in 1997, CMS’s contractors repeatedly communicated with CMS about escalating spending for power wheelchairs
and conducted program safeguard activities to respond to improper payments for this benefit, but CMS did not lead a coordinated effort to address the underlying problems. For example, in 1997, a CMS contractor tasked with analyzing Medicare data warned the agency about rapid increases in power wheelchair spending. Further, in 1998, and again in 2000, reacting to the continuing rise in power wheelchair spending, medical directors at the four DME regional carriers sent joint memorandums to CMS officials outlining steps that could be taken and sought CMS’s support. For example, the medical directors expressed concerns about the certificate of medical necessity (CMN)—a document completed by physicians to provide information with which contractors make payment decisions. They noted that the CMN for power wheelchairs does not provide sufficient information for determining if claims for power wheelchairs should be paid, but CMS did not respond by revising the CMN at that time. During this period, contractors also took other actions, including conducting medical reviews of claims and investigating suspected instances of power wheelchair fraud. However, the amount of funding CMS allotted to them for medical review declined in relation to the rise in Medicare payments. Additional problems related to the power wheelchair benefit surfaced during this period. For example, inspectors had difficulty enforcing two of the broad standards used to screen suppliers before they obtain or renew their Medicare billing privileges.

Because supplier standards do not adequately describe what constitutes an acceptable physical location and sufficient inventory, CMS’s contractor had difficulty interpreting and enforcing these two standards. In addition, Medicare standards for suppliers do not address certain misleading or abusive marketing practices that were a factor in increased utilization of power wheelchairs in Texas. Finally, CMS officials did not address weaknesses in the site visits that are used to assess suppliers’ compliance with Medicare standards. For example, the predictability of visits made it relatively easy for illegitimate suppliers to prepare for, and pass, site inspections. Since September 2003, CMS has led an effort to improve the processes for responding to improper payments for power wheelchairs. The agency’s actions are in different stages of completion and focus on preventing fraudulent suppliers from entering the Medicare program; clarifying the coverage policy; ensuring appropriate pricing for power wheelchairs; educating physicians and beneficiaries on coverage rules; conducting detailed claims reviews in Texas, where power wheelchair fraud was prevalent; and coordinating with law enforcement agencies. Although CMS has made progress, it has not completed a revision to the CMN, clarified guidance on appropriate marketing to beneficiaries, or directed its contractor to conduct less predictably timed site visits to suppliers on a routine basis. Further, CMS’s response to power wheelchair spending highlighted the lack of a process within the agency to rapidly respond to indications of potentially improper DME payments.

GAO offered its recommendations to increase CMS capacity for spotting and responding to fraud in similar situations:

To help ensure that improper payments are identified and addressed in a timely manner and that Medicare pays properly for power wheelchairs and other items of DME, we recommend that the Administrator of CMS take four actions. We are recommending that CMS (1) establish a process to more quickly respond to indications of potentially improper DME spending, (2) finalize revisions to the CMN to make it a more effective tool for claims adjudication, (3) develop a more prescriptive supplier standard on appropriate marketing practices, and (4) amend the supplier inspection process to require that out-of-cycle inspections be routinely conducted.

[tm]

December 17, 2004 | Permalink | Comments (0)

Another Human-Research Imbroglio

Hafford As reported by the Associated Press (courtesy of Yahoo!News), "[a] pregnant Tennessee woman who enrolled in federally funded research in hopes of saving her soon-to-be-born son from getting AIDS died last year when doctors continued to give her an experimental drug regimen despite signs of liver failure, government memos say":

Family members of Joyce Ann Hafford say the 33-year-old HIV-positive woman died without ever holding her newborn boy. They also said they never were told the National Institutes of Health (news - web sites) concluded the drug therapy likely caused her death.

The family first learned of NIH's conclusions when The Associated Press obtained copies of the case file this month. For the past year, they say they were left to believe Hafford, of Memphis, Tenn., died from AIDS complications but began pursuing litigation to learn more.

One recurring theme in this story is the utter  ineffectualness of informed consent in research settings:

[Dr. H. Clifford] Lane [NIH's No. 2 infectious-desease expert] said Hafford should have signed a 15-page, NIH-approved consent form at the start of the experiment specifically warning her of the risks of liver failure. The family says Hafford seemed unaware of the liver risks. They even kept the bottle of nevirapine showing it had no safety warnings.

"My daughter didn't know any of the warning signs," said Rubbie Malone, Hafford's mother and now caretaker of Hafford's new baby and older son. "She never got to hold her baby."

Lane confirmed the nevirapine bottle Hafford received likely wouldn't have had safety warnings because the experiment's rules called for the patient to be unaware of the exact drug effects to avoid patient influence on the test results. That means the consent form would have been her lone warning about potential liver problems, he said.

That 15-page, single-spaced consent form is chock full of complex medical terms like "hypersensitivity reactions" and "pharmacokinetic test." The warning about potential liver problems shows up on the sixth page, where it said liver inflammation was possible and "rarely may lead to severe and life threatening liver damage and death."

The story also raises questions about the quality of care in Hafford's case: "NIH's documents suggest Hafford's life might also have been spared if the drug had been stopped when the first liver problems showed up in her blood work two weeks before death":

"Ouch! Not much wwe (we) can do about dumd (dumb) docs," Dr. Edmund Tramont, NIH's AIDS Division chief, responded in an e-mail after his staff reported that doctors continued to administer the drugs nevirapine and Combivir to Hafford despite signs of liver failure.

[tm]

December 17, 2004 | Permalink | Comments (0)

Thursday, December 16, 2004

Health Care Costs Top List of Americans' Concerns

The Kaiser Family Foundation's latest bimonthly report on public opinion concerning health care issues was released today. Health care costs and access to care top the list, far outpacing the public's concerns over quality:

When asked about the most important health problem for the government to address, health care costs were mentioned by almost half of respondents (46%). Other responses include access to care and insurance (25%) and senior citizens' issues (16%).

In addition to open-ended questions, we also ask the public to choose the most important issue for President and Congress to address among several specific health care issues. About three in ten say increasing the number of insured Americans (29%) is most important, followed closely by lowering the cost of health care and insurance (25%). Smaller shares say lowering the cost of prescription drugs (14%), reducing medical errors (13%) and lowering the cost of medical malpractice insurance for physicians (8%) are top priorities.

Overall, Americans rank health care third among their worries, behind only war and the economy:

When asked in an open-ended question to name the most important problem for the government to address, war and the economy top the list with three in ten (31%) naming each of these as the top priority. Health care ranks third at 26%. Fewer people name terrorism (15%), tax and budget issues (9%), education (6%), social security (5%) and crime (4%) as the most important problems to be addressed.

[tm]

December 16, 2004 | Permalink | Comments (0)

SSRN: Recently Added -- The Commodification Debate

Cohen, I. Glenn, "The Price of Everything, the Value of Nothing: Reframing the Commodification Debate." Harvard Law Review, Vol. 117, p. 689, 2003 http://ssrn.com/abstract=479321:

Under current law, sperm, art, pollution rights, and life insurance can be sold; votes, organs, draft cards, and children cannot. Demarcating a line between what can and cannot be permissibly sold is the goal of the commodification debate (also sometimes called blocked exchanges.)

This paper attempts to add some precision to the dialogue by mapping out the conceptual space of the commodification debate and deriving (and tentatively evaluating) the entailments of different positions adopted by anticommodificationists - those opposing the sale or trade of certain goods.

I begin by dividing coercion arguments (focused on the autonomy of the seller of the good and inequality in background conditions) from corruption arguments (focused on the idea that sale of the good corrupts it, or does violence to the way we think the good is best valued.)

I further subdivide coercion arguments between those that focus on the voluntariness of the seller (e.g., if organ sale was allowed only very poor people would want to sell) and those focused on access (e.g., if organ sale was allowed only the very rich would be able to pay the premium prices to access it). I demonstrate that both forms of the argument share the same philosophical basis point, and both can be eliminated by using the same public policy solutions (e.g., placing a fairly low price ceiling on the good).

The second set of arguments, the corruption arguments, prove more interesting because they do not depend on a particular state of the world and are less susceptible to public policy solutions. The crux of these arguments is that an exchange is corrupting when the relevant goods cannot be aligned along a single metric without doing violence to our considered judgments about how these goods are best characterized. More specifically, one might suggest that there are various spheres (sometimes called modes) of valuation, and an exchange is corrupting when it ignores the differences between these spheres of valuation and forces us to value all goods in the same way. For example, exchanging children for money corrupts the value of children because children belong in a higher sphere of valuation than does money.

I show that the corruption arguments can also be subdivided into two categories, Conventionalist arguments (which argue that determining how a good should be valued and which exchanges are improper is relative to a particular society at a particular time) and Essentialist arguments (which argue that goods have an essence or nature that determines how a good should be valued and which exchanges are improper).

After examining the shortcomings of the Conventionalist account, I try to develop a nuanced approach to the Essentialist position. I catalogue various possible conceptions of how many spheres of valuation exist and how they are divided, and evaluate the merits of the various conceptions. I conclude, however, that any such account will end in failure if it cannot explain why the sale or barter of a particular good (e.g., an organ) should be blocked, while the gifting of the same good (organ donation) is permitted.

My solution is to suggest that a plausible Essentialist position has to offer not only an account based on the nature of the goods exchanged, but also an account based on the nature of the transaction. I offer one such account I call the formula from the nature of the transaction that argues that part of what makes an exchange improper is the transaction's expression of value equilibrium - that the things being exchanged are of equivalent value. I suggest that this is why gift exchanges like organ donation are not improper on the Essentialist anticommodificationist account, and also explains why compensation for the medical costs and lost wages of a mother in a surrogacy contract is different from commercial surrogacy (a blocked exchange) - the former transaction recognizes that the money is not a substitute for the child, that some value remains uncompensated, whereas the latter does not.

The page proofs can be downloaded here.  The traditional electronic legal databases have it here (Lexis) and here (WestLaw); both require a paid subscription.  [tm]

December 16, 2004 | Permalink | Comments (0)

Wednesday, December 15, 2004

SSRN: Recently Added -- Law and Economics & PAS

Added to the SSRN database on Dec. 9:  Daniel J. Gilman (Univ. of Maryland School of Law), Thou Shalt Not Kill as Defeasible Heuristic: Law and Economics and the Debate Over Physician-assisted Suicide, Oregon Law Review, Vol. 83, No. 4, Spring 2005.

ABSTRACT: Although the literature addressing medical decisions at the end of life is vast, surprisingly little of it has come from the perspective of law and economics. This article begins with a critical account of one of the very few law and economics-based discussions of physician-assisted suicide (PAS), that developed by Judge Richard Posner in his book, Aging and Old Age. Central to Judge Posner's account is a model of PAS as a sort of technological innovation. What this particular innovation is supposed to bring is a radical reduction in certain critical information costs attending end-of-life decision making. It is argued that Judge Posner's model - although innovative and instructive - is incomplete and, consequently, inadequate to the normative task of justifying a change in legal regime with regard to PAS. Certain cognitive issues are held to confound the already difficult task of securing bona fide patient consent. That prompts interesting questions about how to value inevitable errors in consent, questions examined in light of the risk management literature regarding valuation of life methodologies. It is argued that the PAS debate makes telling certain difficulties in such methodologies. It is also argued that we ought to adopt conservative standards with regard to attempts to legislate revisions in certain fundamental moral norms. Finding that Judge Posner and others have failed to meet such standards is an argument on behalf of what is, under the laws of most states, the status quo.

A working draft of this paper can be downloaded here[tm]

December 15, 2004 | Permalink | Comments (0)

Criminals in the Profession?

The AMA reports on the increasing use of fingerprint and criminal background checks by state licensing boards as a way to increase patient safety.  Currently there are at least twelve (12) states that mandate such background checks and several other states are considering adopting such a requirement.  The AMA does not have an official position on the criminal background checks.  The article does not make it clear how many physicians have been disqualified due to criminal misdeeds.

[BM]

December 15, 2004 | Permalink | Comments (0)

Vioxx Defense

Forbes has an article concerning Merck's potential defense in the Vioxx cases.

Also, last night Frontline (PBS) had a story on the FDA and its relationship to the pharmecutical industry.  It discussed briefly the Vioxx withdrawal and potential blockbuster liability, but focused mainly on the increasing interrelationship between the FDA and pharmecutical companies in terms of monitoring newly released drugs and the funding for various FDA safety reviews of drugs.

December 15, 2004 | Permalink | Comments (11)

The Big Blues - Anthem/Wellpoint Merger

The American Medical Association reports on the November 30th merger between Anthem and Wellpoint.  Wellpoint, Inc., as the new company will be called, will cover approximately 28 million members in 13 states, primarily under Blue Cross and Blue Shield brands.   The merger makes WellPoint the largest publicly traded health plan in the nation.  Naturally, there exist some misgivings about the size and potential new influence of  Wellpoint, Inc.

" . . . Donald J. Palmisano, MD, immediate past president of the American Medical Association, criticized mergers such the Anthem-WellPoint deal as potential threats to free trade in health care because they're rapidly reducing the number of competitors vying for business. The resulting few large plans, wielding far greater power, could be in a better position to dictate patient care against doctors' wishes or demand unfair terms when bargaining with physicians, he said.

"The AMA continues to be concerned about the mergers of these large companies, where we have a great concentration of patients under one [owner]," he said. "Twenty eight million covered lives -- we don't feel that's in the patient's best interest.""

[BM]

December 15, 2004 | Permalink | Comments (0)

News on Anti-Depressants

In case you haven't noticed, anti-depressants have been making the news recently and much of that news has been negative.  Now, JAMA has a book review on "Let Them Eat Prozac:  The Unhealthy Relationship Between the Pharmaceutical Industry and Depression" by David Healy.   The reviewer Dr. Varley does not wildly enthusiastic about the book to say the least, although he does state,

"This book could raise awareness of legitimate, serious questions about how effective antidepressant medications are for the treatment of depression. This awareness is especially relevant given issues about the efficacy and safety of antidepressant medication in children and adolescents. There has been vigorous academic debate, regulatory action, and media attention in Great Britain and in the United States. However, the book might also discourage the public from seeking treatment for mental disorders, and even alienate the public from mental health professionals. Data already suggest that the majority of children, adolescents, and adults with major depression are not receiving psychiatric treatment that might benefit them. Although an informed consumer can potentially make better use of mental health services, being the recipient of assertions without substantial foundation could potentially obstruct access to helpful care."

However, Dr. Varley has some further concerns with the book and wants physicians and others to be aware of its publication for a number of reasons.  He states, 

"Physicians should be aware of Let Them Eat Prozac. Elements of international "conspiracy" (p 79), implied malfeasance by high-ranking individuals, and consequences in the billions of dollars are provocative themes. The public might embrace this book. It is important to be aware of what is asserted and the foundations upon which those assertions are based in order to provide best care to patients. Healy’s intimate involvement for many years in academic psychiatry, regulatory agencies, and the pharmaceutical industry provides a unique opportunity to examine a highly pertinent topic. Other strategies could have been put forward to address important concerns. Rather than implying misconduct, not only by the pharmaceutical industries but by respected international experts in psychiatry and regulatory agency, the author could have chosen a less inflammatory approach by pointing out relevant questions and solutions regarding what is a controversial theme. In that sense, this book is a disappointment."

Thanks to Jim Tomaszewski for this update.

-BM 

December 15, 2004 | Permalink | Comments (0)

Tuesday, December 14, 2004

Large Cuts Predicted for Medicare and Medicaid

Leavitt The first item on the agenda for newly-nominated HHS Secretary Leavitt may be overseeing large cuts in Medicare and Medicaid.  According to the Associated Press,

"The Medicare and Medicaid programs, consuming nearly $500 billion a year and growing quickly, could be vulnerable in the context of last year's $413 billion budget deficit, the ongoing war in Iraq,  costly domestic security commitments and administration plans to revamp Social Security without raising taxes."

December 14, 2004 | Permalink | Comments (0)

Blind Couple Gain Custody of Child

Yesterday, National Public Radio reported on an interesting disability rights story.  NPR reported that Marco and Adelina Zepeda of Redwood California had reached an agreement with Child Protective Services that permits them to retain custody of their newborn child.  The couple had to get approval from Child Protective Services before they were allowed to take their healthy child home because the Hospital and child welfare had safety concerns apparently related to the fact that both the Zepedas are blind.   The hospital and child welfare officials did not explain why they had concerns about the Zepedas' ability to care for their son.   According to NPR, the story had a happy ending but the Zepedas are still upset and concerned about their treatment.   

I wonder if this happens very often with less favorable results.  Although we can all understand that the hospital would be concerned about patient safety, it does appear that they were heavy-handed in their approach.

December 14, 2004 | Permalink | Comments (0)

SSRN: Recently Added: Selective Non-Treatment of Disabled Babies and Young Children

Added to the SSRN database on Dec. 1: Janet Read & Luke Clements, Demonstrably Awful: The Right to Life and the Selective Non-Treatment of Disabled Babies and Young Children, Journal of Law and Society, Vol. 31, No. 4, pp. 482-509, December 2004.

ABSTRACT:  Twenty-five years ago it was common practice to bring about the deaths of some children with learning disabilities or physical impairments. This paper considers a small number of landmark cases in the early 1980s that confronted this practice. These cases illustrate a process by which external forces (social, philosophical, political, and professional) moved through the legal system to effect a profound change outside that system - primarily in the (then) largely closed domain of medical conduct/practice. These cases are considered from a socio-legal perspective. In particular, the paper analyses the reasons why they surfaced at that time, the social and political contexts that shaped the judgments, and their legacy.

Full text is available from Blackwell's for a fee.

December 14, 2004 | Permalink | Comments (0)

New Report from GAO

On Dec. 13 the Government Accountability Office released a new report on Medicare: Medicare Physician Fee Schedule: CMS Needs a Plan for Updating Practice Expense Component GAO-05-60, December 13, 2004, Abstract / Highlights-PDF.  Here's the abstract:

Medicare's payments for the costs physicians incur in operating their practices are based on two sets of estimates: total practice expenses and resource estimates for individual services. Total practice expense estimates were derived from American Medical Association (AMA) physician surveys, which the Centers for Medicare & Medicaid Services (CMS) refines with supplemental data submitted by medical specialty societies. Resource estimates for individual services were developed by expert panels and refined by CMS with recommendations from another expert panel. In response to a mandate in the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000, GAO evaluated CMS's processes for updating total practice expense and resource estimates and whether CMS will have the data necessary to update the fee schedule at least every 5 years as mandated by law.

CMS reviews supplemental data from medical specialties on total practice expenses to determine whether it should use the data, but aspects of CMS's review may result in its not utilizing the best data. CMS's review is necessary because it helps protect against perceived or actual bias in the estimates. Risk of bias exists because only specialties that believe their Medicare fees are too low are likely to submit supplemental data, and the data are not audited. CMS, however, may still use certain data submissions that are not representative of physician practices within a specialty. CMS also may reject some data that are more representative of a specialty's total practice expenses than the data currently used for that specialty. In addition, CMS reviewed a 2002 data submission for accuracy, which is an important additional check, yet when the data did not meet the accuracy test, CMS did not reject the data. CMS has not stated whether it will review the accuracy of all supplemental data submissions. Stakeholders such as specialty societies and AMA said the expert panel improved resource estimates for individual services because of the rigor of its evaluation process. CMS and specialty societies generally accepted the panel's estimates because the panel represented a broad range of specialties and its collaborative evaluation process became increasingly systematic. CMS implemented almost all of the panel's estimates but appropriately changed some estimates that conflicted with Medicare coverage rules and changed others to make them consistent across services. In modifying other estimates, however, CMS did not always rely on adequate data or explain its rationale. Certain physician groups told GAO that this had diminished their confidence in the process for updating Medicare's fees, and physicians' confidence in the process is important to ensure their continued participation in Medicare. CMS does not have a plan for developing and using appropriate data for the mandated review of the fee schedule. CMS reported that it is in the process of obtaining a contract to collect practice expense data from the major physician and nonphysician specialties but did not provide specifics. A plan for the data collection is important for several reasons. Data sources that had been used no longer exist or are insufficient. The AMA physician survey that provided total practice expense data was last conducted in 1999 and was modified in 2000 such that it no longer collected the necessary data. Data submitted voluntarily by specialties to update these estimates are not an appropriate substitute for a systematic data collection effort. In addition, the expert panel that reviewed resource estimates for individual services completed its work in its final meeting in March 2004. CMS indicated that an ongoing AMA committee would continue to develop estimates for new and revised services. While CMS officials told GAO they believe CMS can complete the review of the fee schedule as required by 2007, without a specific plan CMS cannot ensure that it will be able to collect the data and update the fee schedule in a timely manner.

December 14, 2004 | Permalink | Comments (0)

Monday, December 13, 2004

Lawsuit Challenges Abortion Language in Spending Bill

The National Family Planning and Reproductive Health Association filed suit to stop what it claims is "a conflict between a law that requires health care providers to inform women about abortions and a new rule passed by Congress."  As an example, the NFPRHA said that the newly enacted law would put a publicly funded hospital at risk of a discrimination lawsuit by a nurse fired for refusing to refer a pregnant woman who wants an abortion. However, that same hospital is required to provide the information as a condition for receiving federal grant money.  California Attorney General Bill Lockyer also has filed suit against the provision, which he called, among other things, an attack on state sovereignty.  For a full copy of the NFPRHA press release and copies of the court filings, see http://www.nfprha.org

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December 13, 2004 | Permalink | Comments (0)