Orszag Proposes Evidence-Based Standards for Malpractice Reform

On October 20, the New York Times published an op-ed piece Peter Orszag, the director of the White House Office of Management and Budget from 2009 to 2010.  According to Orszag, the threat of medical malpractice liability leads to the practice of defensive medicine and a departure from the use of evidence-based guidelines.  To correct this pattern, Orszag proposes that medical liability laws be reformed to create a safe harbor for physicians who follow evidence-based guidelines.  Let’s break it down.

Defensive Medicine

Orszag posits that “too many doctors order unnecessary tests and treatments only because they believe it will protect them from a lawsuit.”  But what impact to defensive spending have on the bottom line?  Researchers and economists question the financial impact of medical malpractice litigation and defensive medicine.  As the HealthReformBlog published, Bloomberg reported the following:

[A] March 2003 study by the U.S. Department of Health and Human Services that estimated the direct cost of medical malpractice was 2 percent of the nation’s health-care spending… A 2004 report by the Congressional Budget Office also pegged medical malpractice costs at 2 percent of U.S. health spending and “even significant reductions” would do little to reduce the growth of health-care expenses.

Malpractice is “a big issue for doctors but whether it’s a big issue for the American health-care system is another question,” [Robert Laszewski, an Alexandria, Virginia, consultant to health insurers and other companies], said in a telephone interview. “There are studies that indicate that medical malpractice reform would not have a huge impact on costs, but that is not what doctors think.”…

However, Orszag focuses not on the waste created from litigation, but the waste created from perceived threat of litigation.  He states, “[t]he academic literature tends to play down the role of medical liability laws in driving up health care costs. Doctors themselves, however, almost universally state that malpractice statutes lead to extraneous testing and treatment.”

Could physician fear be a larger problem than the perceived threat?  According to the same March 2003 study (as reported by Bloomberg), “defensive medical practices accounted for 5 percent to 9 percent of the overall expense.”  However, more recent research (nod to Jordan Cohen’s Reform Rodeo) reports that “annual medical liability system costs, including defensive medicine, are estimated to be $55.6 billion in 2008 dollars, or 2.4 percent of total health care spending.”

Therefore, reductions in defensive medical practices may, but will likely not, make a significant impact on health care spending.

Evidence-Based Safe Harbor

Orszag then argues, “[w]hat’s needed is a much more aggressive national effort to protect doctors who follow evidence-based guidelines. That’s the only way that malpractice reform could broadly promote the adoption of best practices.”  He explains the current problem with the law, and proposes a solution:

It is also conceivable that because [medical liability] laws usually focus on “customary practice” — that is, a doctor who has treated a patient the way most other doctors in the area would is considered safe from accusations of malpractice — they create a strong contagion effect among doctors. The laws, no matter how weak or stringent, may therefore explain why doctors in some parts of the country generally adopt much more intensive approaches than those in other areas do.

The traditional way to reform medical malpractice law has been to impose caps on liability — for example, by limiting punitive damages to something like $500,000. A far better strategy would be to provide safe harbor for doctors who follow evidence-based guidelines. Anyone who could demonstrate that he has followed the recommended course for treating a specific illness or condition could not be held liable.

This proposal raises many questions and issues with regard to implementation.

Issues of Implementation

What happens when the recommended course of treatment is inappropriate? No two patients are alike.  Feinstein & Horowitz raise the issue that “the results show comparative efficacy of treatment for an ‘average’ randomized patient, not for pertinent subgroups formed by such cogent clinical features as severity of symptoms, illness, co-morbidity, and other clinical nuances.”  In addition to the variation between patients and their unique combination of health problems, guidelines neglect to take into account patient preferences.  Also, many guidelines presuppose accurate diagnosis.

Timmermans & Mauck describe the problems associated with “cookbook” medicine put forth by critics of evidence-based medicine:

“Ironically, EBM may also result in a lower standard of safety by deskilling practitioners. Instead of using clinical judgment, practitioners will be encouraged to follow protocols that treat all patients as essentially interchangeable. Providers will therefore be poorly equipped to contend with the variations between patients they will encounter in actual clinical circumstances.”

What if the recommended course of treatment is wrong? Orszag explains the selection of evidence-based guidelines very simply.  “Organizations like the American Medical Association and the Institute of Medicine could also be called upon to issue the needed evidence-based standards for malpractice immunity.”  However, the consensus that surrounds guidelines is more complicated than that.

For instance, what if the American Medical Association and Institute of Medicine disagree over the recommended course of action?   According to David Atkins, et al., “[a]n evidence-based approach to health care policy decisions will neither eliminate controversy nor relieve policymakers of the difficult task of making decisions in the absence of clear scientific consensus… Differing values and resource constraints can produce conflict even when there is good evidence and the policy outcomes are clear.”

Additionally, Mendelson & Carino report that evidence based medicine “cannot be meaningfully practiced in the absence of good clinical studies. Lack of evidence is a major limitation of applying such principles–especially for technologies and medical practices that are not new and might not have been thoroughly tested.”

However, Orszag argues that PPACA will tackle other problems raised by critics.  For instance, Mendelson & Carino point out that “A second barrier to achieving evidence-based clinical practice is the lack of automation in the practice setting. It is unrealistic to expect doctors to be able to easily reference a clinical guideline in a busy practice setting.”  However these authors concede that the “[a]doption of computerized decision-support systems paired with EMRs have been shown to improve compliance with clinical guidelines for patients with diabetes and depression.”  Orszag believes “[s]ubsidies in the stimulus act help doctors pay for this kind of technology.”

In Conclusion…

Orszag’s proposal is intriguing, despite the questions raised regarding the effects of defensive medicine and the proposal’s implementation.  If defensive medicine is a race to the top — to see which physician can do the most to mitigate liability — any strategy to reduce waste is laudable.  Although the introduction of evidence-based guidelines as a legal standard for physicians may appear logical, there are still several hurdles to be overcome.

Office of the Inspector General Releases 2011 Work Plan

On October 1, the Office of the Inspector General (”OIG”) of the U.S. Dept. of Health & Human Services (”HHS”) released its Work Plan for Fiscal Year 2011 (”Work Plan”).  Each year, the OIG briefly outlines activities that OIG “plans to initiate or continue with respect to the programs and operations” of HHS.  Various offices within OIG conduct audit, evaluation, investigation, enforcement, and compliance activities.

Continuing Work Within OIG

Many of the topics outlined in the Work Plan were included in last year’s plan.  Although the repeated inclusion of these areas of focus makes compliance easier for facilities, audits should still be conducted in the following areas:

• Provider-based status
• Observation services (as part of an outpatient visit)
• Part A hospital capital payment
• Critical access hospitals
• Medicare disproportionate share payments
• Duplicate graduate medical education payments
• Hospital readmissions
• Hospital admissions with conditions coded present-on-admission
• Inpatient rehabilitation facility transmission of patient assessment instruments
• Medicare excessive payments

New Issues to be Targeted

“What we’re really looking at are four or five really brand new issues,” said Stephen Miller, JD, chief compliance and privacy officer for Trenton, NJ-based Capital Health System, Inc. for HealthLeadersMedia.com.

• Brachytherapy reimbursement
• Replacement of devices received at no cost or reduced cost
  • According to Debbie Mackaman, RHIA, CHCO, regulatory specialist for HCPro, Inc., in Marblehead, MA, “Since the medical devices replacement issue can be a difficult billing procedure to comply with, facilities should certainly do an in-depth process audit in this area.”
• Safety and quality of intensity-modulated radiation therapy (IMRT) and image-guided radiation therapy (IGRT)
  • Indicates a responsiveness on the part of OIG to headlines regarding quality concerns.  In March, the Nuclear Regulatory Commission fined Philadelphia Veterans Affairs Medical Center $227,500, its second largest fine ever against a medical institution, after “unprecedented number” of radiation errors in treating prostate cancer patients.
• Hospitals’ application of the “three-day rule” and “one-day rule” under the Preservation of Access to Care for Medicare Beneficiaries and Pension Relief Act of 2010
  • Many hospitals have had difficulty in billing under the new rules, which redefined what services are related to the admission, and therefore not eligible for Medicare payment within the defined window.  According to Mackaman, “IPPS facilities should be vigilant about reviewing the current three-day rule, and the non-IPPS hospitals should review the addition of the one-day rule.”  CMS guidance on this topic can be found here.

OIG Review of FDA Administration

As HealthReformWatch previously reported, nine Food & Drug Administration (”FDA”) scientists from the Center for Devices and Radiological Health (”CDRH”) sent a letter to President Obama stating, in relevant part, that:

the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk. Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices…have ignored serious safety and effectiveness concerns of FDA experts. Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid.

These scientists also wrote to Congress in 2008, accusing the top FDA officials of “serious misconduct” in ignoring scientist concerns and “approving for sale unsafe or ineffective medical devices,” according to the N.Y. Times.

According to Washington G-2 Reports, OIG also stated on September 29 that “it would re-examine the concerns of those FDA reviewers, and broaden the scope of its inquiry.”

This coming year, OIG intends to investigate CDRH “policies and procedures for resolving scientific disputes about approval of devices.”  The Work Plan states that OIG will:

review a sample of administrative files for disputed device decisions and assess the extent to which regulations, policies, and procedures were followed during the dispute resolution process. We will also assess whether CDRH managers and staff are aware of and trained on policies and procedures for resolving scientific disputes.

Additionally, OIG will continue to review FDA oversight of investigational new drug applications, the process for device approval, and oversight of postmarketing surveillance studies of medical devices.

FDA and CMS Propose Parallel Review of Medical Products

On September 17, the Centers for Medicare and Medicaid Services (CMS) and Food and Drug Administration (FDA) announced their consideration of a parallel review “process for overlapping evaluations of premarket, FDA-regulated medical products,” and their intention to create a pilot program for parallel review of medical devices.

According to the request for comments published in the Federal Register, the new process would be initiated when “the product sponsor and both agencies agree to such parallel review.”  This collaboration is among the first fruits of a June memorandum of understanding between both departments of Health and Human Services (HHS),which is intended to “promote initiatives related to the review and use of FDA-regulated drugs, biologics, medical devices, and foods, including dietary supplements.”

Among the goals set out by the agreement, the FDA and CMS sought to “[b]uild infrastructure and processes that meet the common needs for evaluating the safety, efficacy, utilization, coverage, payment, and clinical benefit of drugs, biologics and medical devices.”  The proposed parallel review process would do just that.

The proposed process is intended to reduce the time delay between “FDA marketing approval or clearance decisions and CMS national coverage determinations.”  Currently, medical products are first reviewed by the FDA for safety and effectiveness; then, CMS begins the process of making its coverage determination and payment rate, which can take up to a year.  Although CMS is only one of many third-party payors, many others follow CMS’ lead in making their own coverage decisions.  A reduction in the approval-to-payment time by CMS will positively impact the rate at which all coverage decisions are made.

The parallel process will potentially benefit patients and sponsors.  A parallel process that reduces the “approval-to-payment” time will produce savings for sponsors and lead to timely patient access to new products.   Furthermore, by reducing the time to return on investment, the parallel process may be an incentive for increased investment in innovation.

Hurdles to a Parallel Process

There are significant differences between FDA and CMS review that must be overcome.  The FDA generally reviews safety and effectiveness through various application processes (premarket approval, premarket notification, etc.).  CMS, on the other hand, must make multiple decisions regarding a medical product under the “reasonable and necessary” standard, including: “what items and services it can and should pay for; how it should accomplish the payment; and how much to pay.”

Because the FDA and CMS apply different standards in their review processes, a clinical study that demonstrates the FDA requirements of safety and effectiveness may neglect to address CMS’ “questions concerning the impact of the technology on Medicare beneficiary health outcomes.”  Ideally, the parallel process will guide sponsors to design clinical studies that simultaneously address both FDA and CMS questions.

Moving from a serial to parallel process must be carefully staged in order to preserve agency resources.  There is the potential for CMS waste if coverage decisions are begun (or even worse, completed) for products that are subsequently denied approval or clearance by the FDA.

The Call for Comments

The FDA has asked the public to comment on seventeen different issues, including:

• How parallel review should be implemented and when in the FDA review process it should start
• Whether anyone other than the product sponsor should be able to initiate a request for parallel review
• Which classes of products would benefit most from parallel review
• Whether there exist regulatory, legal or scientific barriers to review, and how they may be overcome.
• The criteria for granting a parallel review request

The FDA and CMS will publish their decisions regarding the proposed parallel review process after December 16, when the comment period closes.

HHS OIG Notifies Drug Manufacturers of New Enforcement Initiative for Price Reporting Requirements

On September 28, the Office of the Inspector General (”OIG”) released a Special Advisory Bulletin regarding a new enforcement initiative regarding the timely submission of certain pharmaceutical data.  Manufacturers will face civil money penalties (CMP) for failing to comply with reporting requirements.

The Center for Medicare & Medicaid Services (”CMS”) relies on the timely reporting of average manufacturer prices (”AMPs”) and average sales prices (”ASPs”) for the implementation of four different programs: the Medicaid Drug Rebate Program, the 340B Drug Pricing Program (340B Program), the Federal Upper Limit (FUL) Program, and the Medicare Part B outpatient prescription drug benefit.

Under the Medicaid Drug Rebate Program, CMS uses AMPs to calculate the rebates owed to state Medicaid programs.  The 340B Program, which requires manufacturers to sell their prescription drugs to certain safety net health care providers at or below specified prices, also uses AMPs to establish price ceilings.  Medicaid’s FUL Program uses AMPs to act as a prudent buyer of multiple-source drugs.  Finally, the Medicare Part B outpatient drug benefit relies on ASPs to establish Part-B covered drug and biologic payment amounts.

Timely and accurate price reporting is important to the effective and efficient administration of the Medicaid Drug Rebate Program, the 340B Program, the FUL Program, and the Medicare Part B drug benefit.   Manufactures are required to report and certify timely and accurate drug pricing information, including AMPs on a monthly and quarterly basis and ASPs on a quarterly basis.

However, multiple reviews of historical reporting by OIG have demonstrated that voluntary compliance has not been fully effective.  For instance:

• The February 2008 report, “Average Sales Prices: Manufacturer Reporting and CMS Oversight,” found that, “between 41 and 52 percent of manufacturers provided ASPs after the statutorily defined due date.”
• The OIG report, “Drug Manufacturers’ Noncompliance With Average Manufacturer Price Reporting Requirements,” released the same day as the Special Advisory Bulletin, determined that during 2008:
  • 53 percent of the 592 manufacturers that were required to submit quarterly AMP reports failed to provide pricing data by the statutorily defined due date.
  • 78 percent of the 579 manufacturers that were required to submit monthly AMP reports failed to provide pricing data by the statutorily defined due date.

Moving forward, OIG will work with CMS to “identify and penalize noncompliant manufacturers through the CMP process.”  Upon a report from CMS that a manufacturer has not submitted a timely report of product pricing information, OIG will exert its authority to impose CMPs of $10,000 per day upon the manufacturer in an effort to improve compliance.

The Ethics of Modern Drugs and Clinical Trials

A recent article in the New York Times raised an interesting question: are traditional, randomized, controlled trials of new genetically targeted cancer drugs unethical?

The piece recounts the story of two cousins, both diagnosed with melanoma.  After enrolling in the last phase of clinical study, the computer lottery selected one cousin to receive PLX4032, experimental “superpills.” The second cousin, now deceased, was relegated to a “notoriously ineffective” course of chemotherapy.

Randomized, controlled trials have become the gold standard in clinical research, comparing competing treatments to determine which extends life most.  The structure of the trial, with an experimental group and control group, is premised on the idea that the comparative effectiveness of the experimental treatment is unknown.  Therefore, one half of the participants in the clinical trial receive a believed to be less effective therapy for a greater good: researchers come to know definitively which treatment is more effective and future patients benefit from that knowledge.

Critics point out that these new drugs are so much more effective than prior treatments that time-consuming clinical trials are futile: the Phase III trial for PLX4032 would cost $100 million and take at least two years before possibly receiving F.D.A. approval.  That is a huge cost, in terms of lives and money, to “prove” what has already been demonstrated in early clinical testing.  Physicians are forced to forego an opportunity “to give patients symptomatic relief, even if the drug turned out not to prolong life.”

Dr. Paul B. Chapman of Sloan-Kettering, a medical oncologist at Memorial Sloan-Kettering Cancer Center and leader of the trial states in the article:

My goal is to find out as quickly as possible in as few patients as possible whether this works.  If we never know, then we’re never going to be able to build on anything.

Making patients’ tumors go away is gratifying.  But that’s not the businss I’m in.  I’m in the business of making people live longer.  That’s what I want to do.

In contrast, Dr. David E. Fisher, a leading melanoma biologist at Massachusetts General  said of the controlled trial:

My personal view is it’s nuts.  I don’t know anyone who hasn’t shuddered at the concept that we can’t let patients on the control arm cross over because we need them to die earlier to prove a point.

The trend towards more targeted and effective drugs changes the framework for evaluating the ethics of clinical trials.  Promising new treatments however, have sometimes been proven to be less effective.  Therefore, the question remains for medical researchers and the F.D.A.: when will early clinical results be so persuasive that a traditional, controlled trial is unnecessary?

A Guide to Genetically Modified Salmon

The FDA is currently reviewing safety and labeling considerations surrounding what could be the first genetically-modified animal-based food.  Aqua Bounty Technologies, Inc. (”ABT”) of Waltham, Mass. requested FDA to introduce “AquAdvantage Salmon” in U.S. food markets.

AquAdvantage Salmon are produced by introduction of an anti-freeze gene of an ocean pout fish  and the growth hormone gene of Chinook salmon into North Atlantic salmon eggs.  As a result, AquAdvantage Salmon grow produce growth hormone during the winter months, reaching maturity twice as quickly as ordinary North Atlantic salmon.  These genetically-modified eggs, which were developed at Prince Edward Island in Canada, will be grown in an inland hatchery in Panama and processed at a nearby plant before shipment to the US.

The salmon is produced by taking a portion of the gene that protects the ocean pout fish against freezing, transplanting it into the growth gene of a Chinook salmon and transferring the blended genetic material into the fertilized eggs of a North Atlantic salmon.

The resulting fish grows during the winter months as well as the summer, unlike an ordinary salmon.

The FDA initiated three days of public hearings on the genetically-engineered (GE) salmon.  On September 19-20, the FDA Veterinary Medicine Advisory Committee (VMAC) reviewed the scientific issues raised regarding the safety of AquAdvantage Salmon.  On September 21, the FDA held a public meeting regarding the “legal principles for food labeling” applicable to AquAdvantage Salmon.

Sunday & Monday: Safety

In preparation for the public meeting, FDA staff concluded that genetically altered salmon that grow at twice the speed as normal salmon were as safe to eat as traditional Atlantic salmon and posed little environmental risk.  According to the FDA staff analysis, “ABT salmon meets the standard of identity for Atlantic salmon as established by FDA’s Reference Fish Encyclopedia. All other assessments of composition have determined that there are no material differences in food from ABT salmon and other Atlantic salmon…”  In reference to the environment, “no effects on stocks of wild Atlantic salmon are expected.”  (ABT’s environmental assessment can be found here.)

Although many forecasted that the eleven-member, FDA advisory panel would vote to approve the “frankenfish,” as some critics called it, no vote was cast. Instead, the panel recommended further research.  According to the Los Angeles Times:

The panel’s chairman, David Senior of Louisiana State University, said he thought members generally believed the fish was safe to eat, but were concerned that some studies had a small sample size.

One panelist, Greg Jaffe of the nonprofit Center for Science in the Public Interest, predicted after the meeting that the FDA would eventually approve the salmon, “but I don’t think the agency’s going to go quickly on this.”
…

Several panelists raised concerns about the fast-growing fish, saying there were not enough data to answer key questions about allergens and other potential risks.

“There are questions that have not been answered by the data that has been presented,” said panelist James McKean, a veterinarian and professor at Iowa State University. But other panelists argued there was no difference between the altered salmon and its natural counterpart.

“I would not feel alarmed about eating this kind of fish,” said Gary Thorgaard, a professor and fish researcher at Washington State University.

An interesting side-note to this discussion is the regulatory pathway for genetically engineered animals for human consumption.  The rDNA introduced into the fish egg is considered a new animal drug for the purposes of the Federal Food, Drug, and Cosmetic Act (”FFDCA”) because it changes the structure or function of the GE animal.  As such, the Veterinary Medicine Advisory Committee reviews the New Animal Drug Application for safety and efficacy, requiring the VMAC to determine:

• whether the article is safe to the animal to which it is administered, which for GE animals bearing heritable rDNA constructs, means the GE animals themselves;
• whether food derived from GE animals is safe, i.e., there is a reasonable certainty of no harm from the consumption of food derived from the GE animals; and
• whether there is likely to be a significant effect on the human environment.

More information about Atlantic salmon and FDA oversight of genetically engineered animals can be found here.

Tuesday: Labeling

During Tuesday’s Part 15 hearing, the FDA sought public comment on “the labeling (including naming) of foods made from the AquAdvantage Salmon, a genetically engineered (GE) Atlantic salmon produced by AquaBounty Technologies, Inc.”  Specifically, the FDA sought public views on:

1. Which facts about the AquAdvantage Salmon seem most pertinent for FDA’s consideration of whether there are any “material” differences between foods from this salmon and foods from other Atlantic salmon. (Keep in mind that the use of genetic engineering does not, in and of itself, constitute a “material” difference under the law.)
2. If FDA determined there are “material” differences, how would that difference be described on a food label in a way that is truthful and nonmisleading. (Keep in mind that it is the difference in composition, or in functional, organoleptic or other material properties that must be described, not the underlying production process.)

GE foods are subject to the same regulations as other foods, and must “bear an appropriate name and a label that is truthful and not misleading.”  Many consumer advocates and environmental groups insisted that GE salmon, if approved, should be labeled as such.  They argued that consumers have a right to know what they are eating.  However, in Alliance for Bio-Integrity v. Shalala, the court granted deference to the FDA’s determination that genetic engineering does not materially alter foods, and therefore, that GE plants did not need to be labeled as such.  According to the D.C. District Court, “the FDA lacks a basis upon which it can legally mandate labeling, regardless of the level of consumer demand.”

Some advocates also sought labeling as a method of monitoring safety.  As the Los Angeles Times reports:

Consumer’s Union, the nonprofit publisher of Consumer Reports, opposed the approval of the salmon, saying it has not been shown to be safe, and argued it should be labeled in the event that it eventually reaches the market. “FDA should require labeling to insure that any unexpected or unintended effects of engineering this salmon … come to FDA attention,” said CU senior scientist Michael Hansen. “Drugs approved by FDA as safe have turned out to have unexpected health effects after they were widely used by consumers.”

The implication: Without labels, how would consumers, if they experience side effects, know that they had eaten GE salmon?

The great salmon debate is not one that will affect consumers in the near future.  It is currently unclear how the FDA will decide on the safety issue and public comment on the labeling issue will remain open until November 22.  Even if passed, ABT does not expect to have AquAdvantage products on market for another two years.

Petitioners Ask OSHA to Regulate Resident Physician Work Hours

On September 2, Assistant Secretary David Michaels for Occupational Safety and Health received a petition requesting that OSHA regulate resident physician and subspecialty resident physicians.  “Depending on the type of residency, physicians-in-training can work anywhere from 60 to 100 or more hours a week, sometimes without a day off for two weeks or more.”  The petition requests that OSHA exercise the authority granted under §3(8) of the Occupational Safety and Health Act to implement the following federal work-hour standard:

(1)   A limit of 80 hours of work in each and every week, without averaging;

(2)   A limit of 16 consecutive hours worked in one shift for all resident physicians and subspecialty resident physicians;

(3)   At least one 24-hour period of time off work per week and one 48-hour period of time off work per month for a total of five days off work per month, without averaging;

(4)   In-hospital on-call frequency no more than once every three nights, no averaging;

(5)   A minimum of at least 10 hours off work after a day shift, and a minimum of 12 hours off after a night shift;

(6)   A maximum of four consecutive night shifts with a minimum of 48 hours off after a sequence of three or four night shifts.

More information about the petition can be found at the Public Citizen-run website, WakeUpDoctor.org.

Present Accreditation Standards

The Accreditation Council for Graduate Medical Education (ACGME), “[a]s the accrediting body for more than 8,800 medical residency programs,… is charged with setting and enforcing standards for supervision and resident duty hours for graduate medical education.”  In 2002, OSHA denied a petition by Public Citizen, the Committee of Internists and Residents (CIR), and American Medical Student Association, citing the voluntary adoption of standards by ACGME.  In 2003, the ACGME set standards that restricted resident work hours to 80 hours per week when averaged over four weeks and no more than 30 consecutive hours of work.  (A breakdown of the differences between the OSHA petition and ACGME 2003 standards can be found here.)

In 2007, the Institute of Medicine (IOM) evaluated resident work standards pursuant to a request from Congress. The resulting report, “Resident Duty Hours: Enhancing Sleep, Supervision, and Safety” found, among other things, that considerable scientific evidence demonstrates that “30 hours of continuous time awake, as is permitted and common in current resident work schedules, can result in fatigue, and that adjustments to the 2003 rules are needed.”  In response, the ACGME proposed revised standards for resident work hours and supervision.  The comment period ended on August 9 and the changes will be implemented after July 2011.

The Substance of the Petition

According to petitioners, the ACGME revised standards are not sufficient.  A study by Landrigan et al. found that even after implementation of the ACGME’s 2003 standards:

• The average work week was 66.6 hours (95% confidence interval [CI] 66.3-66.9);
• The mean length of an extended shift was 29.9 hours (95% CI, 29.8-30);
• 29% of all work weeks were more than 80 hours in duration, 12.1% were 90 or more, and 3.9% were 100 hours or more;
• 83.6% of all interns reported hours of work in violation of the professional self-regulations that were established and are being monitored by the ACGME. This number far exceeds the rates of violations reported by resident physicians and residency programs to the ACGME, indicating both that widespread under-reporting exists, and that the ACGME’s enforcement has been ineffective.

According to the petition, these numbers of hours are among the highest in the professional world and negatively affect personal health and safety.  Despite the previous rejection of a similar petition in 2002, the petitioners have changed their strategy in appealing to OSHA:  “Whereas previous appeals to limit resident physicians’ work hours have focused on the well-documented risks patients face due to tired physicians, this petition concentrates on the often-overlooked health risks faced by the resident physicians who endure those long hours.”  These risks include:

• Motor Vehicle Accidents — In addition to anecdotal evidence that resident fatigue after long work hours has resulted in physical injury and death, the petition offered the following research:
  • A Journal of the American Medical Association (JAMA) informal survey found that “[o]f seven surgical residents in our hospitals who we interviewed, six fell asleep while driving to or from work during their internships and three were involved in motor vehicle accidents.”
  • A New England Journal of Medicine (NEJM) study found that “risk of a motor vehicle crash was increased significantly following a work shift of 24 hours or greater,” as well as the risk of a near miss.
  • Sleep deprivation researchers at John Hopkins Hospital found that “[f]orty-nine percent of resident physicians [questioned] reported falling asleep at the wheel (not necessarily at a stop light), and 90% of these events occurred after the resident physicians had worked an extended duration (> 24-hour) shift.”
  • An Anesthesiology abstract reported that 17% of survey respondents reported post-call automobile accidents and 72% reported near misses.
• Mental Health

  • 

    Capricho No 43, "The sleep of reason produces monsters." Francisco de Goya (1746–1828)

    One study described “house officer stress syndrome.” Caused in large part by sleep-deprivation and excessive work load, physicians-in-training may suffer from (1) episodic cognitive impairment, (2) chronic low-grade anger with outbursts, (3) pervasive cynicism, (4) family discord, (5) depression, (6) suicidal ideation and suicide, and (7) substance abuse.

  • Four studies demonstrated that residents are unhappy, face high levels of stress, and suffer “major problems” in their personal relationships with others.
  • Three studies demonstrated that on-call residents reported greater mood disturbance and increased negative mood than those who were rested.
  • One study found that as many as 30% of residents experience depression during their residencies.
  • A study published in the Archives of Internal Medicine found that 21% of residents reported depressed scores on the Center for Epidemiological Studies-Depression (CES-D) scale and that depressed responses increased with longer work weeks. Two other studies also found increased rates of depression among residents that correlated with high work hours.
• Pregnancy
  • A NEJM study reported that premature labor and preeclampsia or eclampsia was twice as common among pregnant residents as the wives of male residents and that residents working more than 100 hours per week in the third trimester were twice as much at risk for preterm delivery than those that worked fewer than 100 hours.
  • The pre-term labor and preeclampsia risk was validated by a study published in Obstetrics and Gynecology.
  • One study found that infants born during residency significantly more likely to be born with intrauterine growth restriction.
• Percutaneous Injuries (such as needlestick injuries)

  • 

    Saint Sebastian, Carlo Crivelli (1490-91)

    A JAMA study of self-reported percutaneous injuries in residents found that substantially increased risk during day shifts after overnight call as compared with day shifts not preceded by overnight call.

  • “An Annals of Surgery study from 2005 found that 20 to 38% of all procedures in one urban academic teaching hospital involved exposure to HIV, HBV or HCV.”
  • A NEJM study found that 99% of all residents had suffered a needlestick injury by their final year of study. Fatigue was the second most common reason given for the injury.

Additionally, this petition has more public support than the one submitted in 2002.  Petitioners include:

• Public Citizen, a consumer and health advocacy group with 150,000 members and supporters;
• the Committee of Interns and Residents/SEIU Healthcare (CIR/SEIU), a housestaff union, part of SEIU, representing over 13,000 resident physicians;
• the American Medical Student Association (AMSA), a national organization representing over 33,000 physicians-in-training;
• Bertrand Bell, M.D., Professor of Medicine at Albert Einstein College of Medicine and author of New York State Health Code 405 restricting resident physician work hours;
• Charles A. Czeisler, Ph.D., M.D., Baldino Professor of Sleep Medicine, Harvard Medical School;
• Christopher P. Landrigan, M.D., M.P.H., Assistant Professor of Pediatrics and Medicine, Harvard Medical School;
• Plus forty-five health-related organization and over 1,000 individuals.

Response to the Petition

In order to fulfill OSHA’s mission “to send every worker home whole and healthy every day,” the petition argues that OSHA must “act now to address the dangers that extreme work hours pose for resident physicians and subspecialty resident physicians.”

In a statement released the same day, Assistant Secretary Dr. David Michaels recognized the concerns raised by the petition:

We are very concerned about medical residents working extremely long hours, and we know of evidence linking sleep deprivation with an increased risk of needle sticks, puncture wounds, lacerations, medical errors and motor vehicle accidents. We will review and consider the petition on this subject submitted by Public Citizen and others.

The relationship of long hours, worker fatigue and safety is a concern beyond medical residents, since there is extensive evidence linking fatigue with operator error… All employers must recognize and prevent workplace hazards. That is the law. Hospitals and medical training programs are not exempt from ensuring that their employees’ health and safety are protected.

However, ACGME believes that the revised rules under development are adequate.  According to medpagetoday.com, the ACGME said the following in a prepared statement:

As the Occupational Safety and Health Administration reviews a petition from three special interest groups requesting federal regulation of resident duty hours, the Accreditation Council for Graduate Medical Education stands ready to share with OSHA the many studies, evidence, and documentation that substantiate the standards proposed by the ACGME Task Force on Quality Care and Professionalism.

Revised Horizontal Merger Guidelines issued by FTC and DOJ

On August 19, the Federal Trade Commission (”FTC”) and Department of Justice (”DOJ”) issued revised Horizontal Merger Guidelines (”guidelines”).  First adopted in 1968 and revised in 1992, the guidelines are an outline of the primary “analytical techniques, practices and enforcement policies” used to evaluate mergers and acquisitions of actual or potential competitors under federal antitrust laws, including Section 7 of the Clayton Act, 15 U.S.C. § 18, Sections 1 and 2 of the Sherman Act, 15 U.S.C. §§ 1, 2, and Section 5 of the Federal Trade Commission Act, 15 U.S.C. § 45.

As the first major revision in 18 years, the FTC and DOJ assert that the guidelines are not a change in policy, but a clarification of the merger review process.  In 2006, both agencies issued “Commentary on the Horizontal Merger Guidelines,” the first step towards the refinement of the guidelines.  The agencies jointly announced the project in September 2009.  They posed a number of questions for public comment and conducted a series of workshops this past winter.  As a result, 51 parties provided comments for the revisions.  The agencies further considered 31 written comments to the proposed revisions issued on April 20.

According to the FTC Press Release, the guidelines are primarily aimed to “help the agencies identify and challenge competitively harmful mergers while avoiding unnecessary interference with mergers that are either competitively beneficial or likely will have no competitive impact on the marketplace.” In addition, the guidelines are intended to assist private parties, courts and antitrust practitioners.  Representatives of both agencies had the following to say:

“Because of the hard work of all involved at both agencies, private parties and judges will be better equipped to understand how the agencies evaluate deals. That improvement in clarity and predictability will benefit everyone,” said FTC Chairman Jon Leibowitz…

“The revised guidelines better reflect the agencies’ actual practices,” said Christine Varney, Assistant Attorney General in charge of the Department of Justice’s Antitrust Division. “The guidelines provide more clarity and transparency, and will provide businesses with an even greater understanding of how we review transactions.”

What Has Changed?

According to the FTC Press Release, the guidelines do the following:

• Clarify that merger analysis does not use a single methodology, but is a fact-specific process through which the agencies use a variety of tools to analyze the evidence to determine whether a merger may substantially lessen competition.
• Introduce a new section on “Evidence of Adverse Competitive Effects.” This section discusses several categories and sources of evidence that the agencies, in their experience, have found informative in predicting the likely competitive effects of mergers.
• Explain that market definition is not an end itself or a necessary starting point of merger analysis, and market concentration is a tool that is useful to the extent it illuminates the merger’s likely competitive effects.
• Provide an updated explanation of the hypothetical monopolist test used to define relevant antitrust markets and how the agencies implement that test in practice.
• Update the concentration thresholds that determine whether a transaction warrants further scrutiny by the agencies.
• Provide an expanded discussion of how the agencies evaluate unilateral competitive effects, including effects on innovation.
• Provide an updated section on coordinated effects. The guidelines clarify that coordinated effects, like unilateral effects, include conduct not otherwise condemned by the antitrust laws.
• Provide a simplified discussion of how the agencies evaluate whether entry into the relevant market is so easy that a merger is not likely to enhance market power.
• Add new sections on powerful buyers, mergers between competing buyers, and partial acquisitions.

Analysis by private parties is mixed.  Constantine Cannon LLP writes that the guidelines “reflect a more tolerant approach to mergers, stressing the need to ‘avoid unnecessary interference with . . . competitively beneficial’ mergers.”   In support, Constantine Cannon cites the increased Herfindahl-Hirschman Index (”HHI”) thresholds and statements clarifying that coordination can be legal.

On the other hand, Weil Gotshal writes that the guidelines “appear to provide the agencies with more tools… [and] offer less predictability regarding which analytical methodology will be applied.”  Of primary concern is the decreased emphasis on market definition and increased emphasis on a fact-specific process with a variety of analytical tools.  Revised definitions may create narrower relevant markets which will negate any benefits of higher HHI thresholds.  The newly enumerated categories of evidence may lead to broader document requests and longer investigations.  In providing many alternative techniques and theories, the agency has provided “few true guidelines to assist parties considering a transaction.”

Criticism From Within the Commission

Commissioner J. Thomas Rosch issued a separate concurring statement, in which he “acknowledged” flaws in the guidelines.  According to Commissioner Rosch, the following substantial changes since the 1992 revisions are not reflected in the new guidelines:

First, the Commission is increasingly challenging mergers in preliminary injunction and administrative (Part 3) proceedings…   Second, economic theories embedded in the 1992 Guidelines emphasized price effects almost exclusively. Increasingly, the Agencies and courts have considered nonprice effects, like effects on quality, variety, and innovation, to be no less important. Third, for a variety of reasons, many, if not most, courts have relied on empirical evidence instead of economic evidence, and have considered economic evidence as corroborative of that empirical evidence, if they have considered it at all…  As previously discussed, that in turn has led the staff reviewing mergers ex ante to devote more attention to the empirical evidence that can be presented and defended at trial.

As a result, Commissioner Rosch believes the guidelines do not reflect the way staff at the FTC conduct ex ante merger reviews or the information courts should be told about merger analysis.

According to Commissioner Rosch, the guidelines possess the following additional flaws:

• Stakeholder perspectives were considered unequally. As a result, the guidelines overemphasize “economic formulae and models based on price theory.” Commissioner Rosch credits the large influence of the defense bar, academics, and other kindred souls and at least one private meeting held with the leadership of the ABA Antitrust Section.
• The economic theories of the revised guidelines are improperly based wholly or partially on margins (prices minus incremental costs). Although the draft guidelines acknowledge in two footnotes that “high margins are not in themselves of antitrust concern,” Section 4.1.3 discusses the role of margins in critical loss analysis and as an indication of the sensitivity of demand to price.
• The guidelines say little about non-price competitive effects (ie., how a transaction affects quality, service innovation, and product variety). See page 2 of the guidelines, “[f]or simplicity of exposition, these Guidelines generally discuss the analysis in terms of… price effects.”
• The guidelines fail to offer a clear framework for analyzing non-price considerations. Commissioner Rosch supports this claim with four non-exhaustive illustrations of guideline deficiencies.

Commissioner Rosch’s statement raises many questions about the future of the guidelines.  Are the revised guidelines an accurate statement of current practices?  Will the issuance of the guidelines lead to a greater number of enforcement actions?  How will courts square this administrative document with prior merger and acquisition case law?  Only time will tell.

The Downfall of Mammography?

Mammography’s reputation as gold standard in breast cancer screening took another hit this past month.  As the New York Times reported last week, research studies demonstrate that the radiation emitted by mammography can actually increase the incidence of cancer. Two nuclear technologies, breast-specific gamma imaging (B.S.G.I.) and positron emission mammography (P.E.M.), expose “patients to a risk of radiation-induced cancer that is comparable to the risk from an entire lifetime of yearly mammograms starting at 40.”

While digital mammography has an average lifetime risk of inducing 1.3 fatal breast cancers per 100,000 women aged 40 at exposure, a single B.S.G.I. exam was estimated to involve a lifetime risk 20 to 30 times greater in women aged 40, and the lifetime risk of a single P.E.M. was 23 times greater.

Moreover, mammography only increases a woman’s risk for breast cancer while B.S.G.I. and P.E.M. increase the risk of cancer in other organs, such as the intestines, kidneys, bladder, gallbladder, uterus, ovaries and colon, the study said.

That’s right, the risk of breast cancer is greater in those women that regularly receive mammograms.  At a November 30, 2009 conference, researchers reported that “for young women who have a high risk of breast cancer because of genetic mutations or family history, the radiation from yearly mammograms may make the risk even higher.”  Meta-analysis of prior research pertaining to high-risk women (0.5 - 1% of the population) with a median age of 45 found that “those women who had had mammograms or chest X-rays (which use a lower radiation dose than mammography) were more likely to have breast cancer.”

Researchers Question the Value of Mammography

The great mammogram debate began on October 21, 2009, when a Journal of the American Medical Association article stated that mammography is not as effective as anticipated:

[S]creening may be increasing the burden of low-risk cancers without significantly reducing the burden of more aggressively growing cancers and therefore not resulting in the anticipated reduction in cancer mortality… There are several reasons that may help to explain why screening has not led to a more significant reduction in deaths from these 2 diseases in the United States. First, screening increases the detection of indolent cancers. Second, screening likely misses the most aggressive cancers.

The “increasing burden of low-risk cancers” can be characterized by the high rate of false positive tests, resulting in over-treatment. As a prior HealthReformWatch post reported:

The recent analysis of all the available evidence from multiple studies published in the British Medical Journal shows that if 2,000 women are screened with mammograms regularly for ten years, only one single woman’s life will be prolonged, but 500 will have at least one false positive and ten will be diagnosed with a “cancer” that would never have become a real disease if it had been left alone.

The New York Times reports that since the mammograms became widely used in the 1980s, the diagnosis of ductal carcinoma in situ (D.C.I.S.), what many believe to be a breast cancer precursor, has increased significantly with more to more than 50,000 women in the U.S. each year.  However, the diagnosis of these borderline breast legions has raised concerns that 17 percent of diagnoses are false positives.

Researchers at Dartmouth College succinctly summed up the deficits of mammography.  In addition to the discomfort of x-ray mammography:

• The rate of false negatives from x-ray mammography range from 4% to 34%
• X-ray mammography is less sensitive in women with dense breast tissue (a common among trait among young women who are at high-risk for developing the most aggressive breast cancers)
• Seventy-five percent of biopsied lesions resulting from suspicious mammogram findings turn out to be benign (a false-positive)

It would be surprising if the Food and Drug Administration (FDA) approved an imaging modality with such poor results today.  However, the FDA never approved x-ray mammography for the diagnosis of breast cancer; it was grandfathered by the Medical Device Amendments of 1976 because it was already in clinical use.  The mammogram does not detect cancer directly, but is a measurement of tissue abnormalities such as microcalcifications, architectural distortions, masses, and asymmetrical densities.

The only mammography device to pass the pre-market approval (PMA) process is the T-Scan 2000 ED by Mirabel Medical Systems, a form of impedance imaging.  Research into impedance imaging has received attention because it does not emit radiation, can more accurately image dense breast tissue, and can differentiate between tissue types without biopsy.  Despite producing greater sensitivity in clinical trials than x-ray mammography or ultrasound, it has not become a primary imaging method.

So When Should Mammography Be Used?

The rumblings of debate turned into a roar when the U.S. Preventive Services Task Force (USPSTF) changed its breast cancer screening recommendations.  The Task Force listed many of the foregoing problems, including false positives, overdiagnosis, and radiation exposure, in support of its decision.  Despite the evidence that more effective screening measures are needed, the response in support of x-ray mammography was overwhelming.  As HealthReformWatch reported:

A number of professional and advocacy groups have responded to the Task Force’s November 16 recommendation.   The ACS continues to recommend annual screening using mammography and clinical breast examination for all women beginning at age 40.  The American College of Radiology issued a frankly titled statement, “USPSTF Mammography Recommendations Will Result in Countless Unnecessary Breast Cancer Deaths Each Year” and labeled the recommendations “cost cutting.”  And the American Congress of Obstetricians and Gynecologists continues to recommend a screening mammography every 1-2 years for women aged 40-49 years and every year for women 50 and over, as well as to recommend BSE.

The editors of Annals of Internal Medicine, which published the Task Force recommendations, responded in an editorial titled, When Evidence Collides With Anecdote, Politics, and Emotion: Breast Cancer Screening.  ”Although prevention is vital to public health, none of the previous guidelines grabbed the public’s attention as much as the Task Force’s recommendation against “routine screening mammography in women aged 40 to 49 years.”  Results of an Annals‘ website survey suggested that clinicians are more likely than the general public to be influenced by the Task Force recommendations.  In response, the editors took a position in support of the new recommendations:

Unfortunately, only a fraction of abnormalities initially detected on mammography and subsequently treated truly represents a life saved rather than unnecessary or premature treatment. Sadly, it is also true that many women who have cancer detected by screening die of the disease despite early detection and treatment… Breast cancer prematurely claims the lives of many, but it is wrong to mislead women about the effectiveness of current screening methods. Women deserve to make decisions about screening for breast cancer armed with the best available information about potential benefits and harms.

One survey respondent wrote, “This Task Force has performed a vital service for years. It brings a welcome dose of science to the politics of screening.” The editors heartily agree… Because the USPSTF issued recommendations that were politically unpopular among some constituents, there have been calls to curtail this independent body’s work. If the USPSTF sinks in turbulent waters whipped up by emotion, anecdotes, and politics, Americans should mourn its loss.

Politics and Science in the Breast Cancer Screening Debate

But what role do politics actually play in breast cancer screening?  According to Dr. Barron Lerner of Columbia University College of Physicians & Surgeons, a big one. In an interview with Kaiser Health News, he recounted:

In the late 1990s, Congress passed a bill that mandated that women who had a mastectomy would have their reconstructive surgery paid for. If you think about this, this really doesn’t happen in most areas except for breast cancer, where Congress would act, and say, “This is something we’re forcing insurance companies to do.” But it speaks to the powerful nature of the breast-cancer lobby.

One other time a report came out criticizing mammograms… the House voted 430 to nothing [ed. note: it was 424-0] — to rebuke that scientific report. So, politics is always intruding into the world of breast cancer….

In the early 1990s, there was some suggestion that if you did something called a bone marrow transplant, or stem cell transplant — which was a very aggressive treatment for metastatic breast cancer — that women live longer… The power of that lobby was so strong that insurance companies began to pay for the procedure, even though it was still experimental and its value hadn’t been proven….

It turns out that when the randomized studies came through and we got good data — at the end of the 1990s — that treatment was, in fact, no better than standard chemotherapy and caused more harm along the way. So it was not indicated at all. But, again, this was an example of Congress, or the government, sort of sticking its foot where it shouldn’t — trying to do the right thing, trying to insure access for all women who have a serious disease. But if you don’t look at the data and you’re acting based on your heart, or your gut instinct, you often make the wrong decision.

In supporting some breast cancer treatments, some lobby groups divert important resources away from important goals (e.g., development of an x-ray mammography alternative) and waste them on every promise of hope (e.g., extensive x-ray screening despite evidence of its negative effects).  The most recent example involves the new drug Avastin.

As the Fiscal Times reports, the FDA gave “accelerated approval” for the marketing of Avastin in 2008.  Two confirmatory trials submitted earlier this year led an FDA advisory committee decision to withdraw agency approval.  The first study showed that Avastin did not delay patient death and a second study indicated that patients on Avastin actually died more quickly than those on chemotherapy alone.  In spite of these findings, Susan B. Komen for the Cure chief Nancy G. Brinker and Sen David Vitter, R-La, have called upon the FDA to continue its approval of Avastin.  The FDA has yet to issue a decision.

New Interim Federal External Review Process for Health Insurance Appeals Announced

As reported earlier in New Rules for Insurance Appeals, the departments of Health and Human Services, Treasury, and Labor issued interim final rules on July 23, allowing patient appeals of health insurance coverage.  On August 23, the U.S. Department of Labor, Employee Benefits Security Administration (EBSA) issued Technical Release 2010-01, regarding “Interim Procedures for Federal External Review Relating to Internal Claims and Appeals and External Review” under PPACA.

Looking back at the interim final rules, as they relate to the interim procedures (from New Rules for Insurance Appeals):

Under the rules, new health plans beginning on or after Sept. 23, 2010, must have an internal appeals process for beneficiaries to challenge “adverse benefits decisions” — a “denial, reduction, or termination of, or a failure to provide or make a payment (in whole or in part) for a benefit.”

If the internal appeal is denied, patients may choose to have the claim reviewed by an independent reviewer.  According to Appealing Health Plan Decisions, States are encouraged to adopt the National Association of Insurance Commissioners (NAIC) standards in “their external appeals laws to adopt these standards before July 1, 2011.”  If State laws don’t meet these standards, consumers in those States will be protected by comparable Federal external appeals standards.

The EBSA release “sets forth an interim enforcement safe harbor for non-grandfathered self-insured group health plans not subject to a State external review process, and therefore subject to the Federal external review process.”  The Federal process will apply to plan years beginning on or after Sept. 23, 2010 and will continue until the interim period is over.

The issuer of the “non-grandfathered self-insured group health plans” (hereinafter, “health plans”) is primarily responsible for compliance with the interim final regulations.  During the interim enforcement safe harbor, the Internal Revenue Service (IRS) will not take enforcement action against health plans that comply with either of the two interim methods provided by the EBSA.

1.      Compliance with State external review processes

Health plans may voluntary comply with the provisions of their State’s external review processes.  However, the State must first choose to expand access to their external review processes to health plans that are not subject to relevant State laws.

2.      Compliance with the procedures set forth in the technical release

A health plan may also adopt the external review procedure outlined in Technical Release 2010-01.  The release sets forth procedures based on the Unified Health Carrier External Review Model Act promulgated by the National Association of Insurance Commissioners (NAIC Model Act).  The EBSA procedure requires that an external review may be standard or expedited.

A. Standard Review

Health plans must allow a claimant’s request for external review if filed within four months of the adverse benefit determination.  A preliminary review must be completed by the health plan within five days of the claimant’s request and must determine whether:

a.       The claimant was covered under the plan at the time the service was requested or provided

b.      The adverse benefit determination was related to a failure to meet eligibility requirements

c.       The internal appeals process has been exhausted or is not required

d.      All information and forms required for the external review have been provided

Within one business day of completion, the health plan must provide written notice to the claimant of the health plan’s determination.  If the claimant is not eligible for external review, the health plan must provide the reason for ineligibility.  If the request is incomplete, the health plan must notify the claimant that further information or materials are required and provide the claimant with an opportunity to complete the request.  Health plans must allow the claimant until the end of the four-month filing period or forty-eight hours from the receipt of the notification, whichever is later, to perfect the request.

The health plan must contract with at least three independent review organizations (IRO) to conduct external reviews.  The IROs must be “accredited by URAC or by a similar nationally-recognized accrediting organization.”  An independent, unbiased method for claim assignments, such as rotation or random selection, must be used.  The IRO may not have a financial stake in the outcome of its decision.

The following must be provided in the contract between a health plan and an IRO:

a.       The IRO will utilize legal experts as appropriate.

b.      The IRO will provide the claimant with timely written notification including a statement of the request’s eligibility and acceptance for external review and a statement that claimant may submit additional information for consideration within ten business days of the receipt of notification.

c.       The IRO may choose to consider additional information received ten business days after the receipt of notification.

d.      The IRO must submit all additional information received by the claimant to the health plan within one business day.  The health plan may reconsider its adverse determination and terminate the external review if it decides to reverse its prior determination and provide coverage or payment.

e.       The health plan must provide all documents and information related to the adverse determination within five days; otherwise, the IRO may terminate the external review and reverse the adverse decision.

f.       The IRO will review the claim de novo based on all information and documents timely received.

g.      Within 45 days of the assignment, the IRO will provide written notice of its decision to the health plan and claimant. The decision notice will contain a description of the disputed claim, the date of assignment, and reference to the evidence relied upon and reasoning for its decision.  The notice must provide a statement that the decision is binding to the extent that other remedies may be available under the law and that judicial review is available to the claimant.

h.      The IRO will maintain all records related to a claim for six years and make them available for examination upon request by the claimant, health plan, or government oversight agency.

B. Expedited Review

A group health plan must allow a claimant to request an expedited review when a claimant receives:

(a) An adverse benefit determination if the adverse benefit determination involves a medical condition of the claimant for which the timeframe for completion of an expedited internal appeal under the interim final regulations would seriously jeopardize the life or health of the claimant or would jeopardize the claimant’s ability to regain maximum function and the claimant has filed a request for an expedited internal appeal;

or

(b) A final internal adverse benefit determination, if the claimant has a medical condition where the timeframe for completion of a standard external review would seriously jeopardize the life or health of the claimant or would jeopardize the claimant’s ability to regain maximum function, or if the final internal adverse benefit determination concerns an admission, availability of care, continued stay, or health care item or service for which the claimant received emergency services, but has not been discharged from a facility

The main difference between the expedited and standard review is the timeframe (unsurprisingly).  During an expedited review, the health plan must perform the preliminary review immediately and send notice of its determination immediately.  Upon assignment to the IRO, the health plan must transmit all documents and information related to the claim by any expeditious method.  The IRO must provide notice of the final external review decision as quickly as possible, but no later than 72 hours after assignment of the claim.

Trouble Brewing for Pharmaceutical Companies

Bribery and recalls.  Federal agencies are turning up the heat on pharmaceutical companies.  Were you surprised by the eight recalls of Johnson & Johnson products this year?  Maybe you shouldn’t be.  As HealthReformWatch.com reported in We May Need More Than a Spoonful of Sugar to Help Our Medicine Go Down, drug recalls reached a record high 1,742 in 2009 — more than four times the amount in 2008.  Bowman Cox, managing editor of the Gold Sheet (which first broke the story) told CNN Money that in light of the 296 recalls issued in the first six months of 2010, there could be 600 or more recalls this year.

Why So Many Recalls?

Analysts and legislators are examining the recall statistics to find sources and solutions to the pharmaceutical safety issue.

1.   Drug repackaging

Advantage Dose, a now-defunct Shreveport, LA based drug repackager, was responsible for more than 1,000 of the 2009 recalls. Companies like Advantage Dose repackage and relabel drugs into smaller units for resale or distribution to health care facilities. After excluding Advantage Dose from the count, there still remains a 50% jump in recalls from 2008 to 2009.

2.   The generic rush

Gold Sheet’s Cox suggests that generic manufacturers cut drug design costs in their rush to be first to market after a branded-drug’s patent protection expires, decreasing quality.  “The first applicant typically gets the lion’s share of the business for the new drug… So they get the application. They make and market the drug, but they could still have problems down the road if they haven’t really understood the optimum way to make that drug.”  One example of a design failure is Caraco Pharmaceutical Laboratories’ “tablet thickness” recalls in March 2009.

3.   Manufacturing lapses

Some experts say the biggest culprits include the quality of raw materials and contamination. Approximately one month ago, HealthReformWatch.com reported in Pharmaceutical Outsourcing: Trading Quality for Lower Costs? that India’s largest pharmaceutical manufacturer had been cited several times in recent years for manufacturing violations.  Additional recalls include vaccines produced by Shantha Biotechnics for Sanofi-Aventis and injectible drugs made by Claris Lifesciences for Pfizer.  The FDA stated its intent on May 5, 2010 to “propose stronger regulation for pharmaceutical companies that outsource manufacturing, putting more responsibility on the companies to ensure the purity and safety of the products…”

4.   Increased FDA scrutiny of manufacturing facilities

Which came first, the chicken or the egg?  Increased FDA oversight may or may not have led to the increased number of recalls; however, the recalls will probably lead to increased FDA regulatory power.

As Jennifer Jascoll reported, Senator Michael F. Bennet (D-CO) proposed the Drug Safety and Accountability Act of 2010 on August 3, 2010.  According to Bennet’s press release, “[t]he bill would strengthen manufacturer quality standards, enhance the FDA’s ability to protect Americans through improved tracking of foreign manufacturing sites, and give the FDA much-needed authority to recall potentially dangerous drugs.” Currently, the FDA is empowered to issue warnings and recommend that a manufacturer issue a recall.

Two prior bills would also increase FDA powers to mandate a recall:

• The Protect Consumers Act of 2009 (sponsored by Rep. Betty Sutton, D-OH) would require the Secretary of HHS implement a recall if it is determined to be necessary.
• H.R. 6740 (sponsored by Rep. Edolphus Towns, D-NY) would provide the Secretary of HHS with the ability to mandate a recall “if the Secretary has reason to believe that the use or consumption of, or exposure to, a drug (or an ingredient or component used in any such drug) may cause serious adverse health consequences or death to humans or animals.”

According to CNN Money, the FDA has not identified any alarming pattern.  FDA spokeswoman Elaine Gansz Bobo stated, “[s]ince every recall situation is unique, it would be difficult to assess whether there are any trends or increases in recalls this year… At this time, however, we have not identified any trends.”  Despite the FDA’s lack of concern, other federal agencies are interested in the practices of pharmaceutical companies.

Further Federal Investigations

According to the N.Y.Times, federal prosecutors and securities regulators are investigating pharmaceutical companies for potential violations of the Foreign Corrupt Practices Act (FCPA).   The FCPA is an anti-bribery law which bars companies from offering foreign government officials items of value for profit.  For instance, Pfizer disclosed in April “that it paid $35m over six months to 4,500 doctors in private practice for education and the development and marketing of new drugs.”  Although this practice is legal in the U.S., such payments are illegal in many foreign countries where physicians are employed by the government.

On November 17, 2009, Assistant Attorney General Lanny A. Breuer stated that the Department of Justice intended to focus its attention on the pharmaceutical industry:

In some foreign countries and under certain circumstances, nearly every aspect of the approval, manufacture, import, export, pricing, sale and marketing of a drug product may involve a “foreign official” within the meaning of the FCPA. The depth of government involvement in foreign health systems, combined with fierce industry competition and the closed nature of many public formularies, creates, in our view, a significant risk that corrupt payments will infect the process. Our remarkable FCPA unit and our terrific health care fraud unit will be working together to investigate FCPA violations in the pharmaceutical industry in an effort to maximize our ability to effectively enforce the law in this high-risk area.

“Corrupt practices” under the FCPA are not limited to cash in envelopes.  Inappropriate payments for lavish hospitality, consulting, licensing agreements, and even charitable donations may raise red flags for government investigators.

Could bribery be contributing to decreased quality and the sudden rise in recalls?  According to the Financial Times, the DoJ is focusing its efforts elsewhere:

[T]he DoJ is particularly interested in corrupt payments that may have influenced the reliability or integrity of data in clinical trials performed outside the US. A recent report by the Department of Health and Human Services found 80 percent of marketing applications for drugs approved by the Food and Drug Administration in the US had relied on at least one foreign trial.

It appears that the DoJ’s scrutiny of clinical trials is not without merit.  The N.Y.Times reports that “[l]ast month, a federal drug official reported that he found repeated instances in a landmark clinical trial of Avandia, a controversial diabetes medicine, in which patients taking Avandia appeared to suffer serious heart problems that were not counted in the study’s crucial tally of adverse events.”  The clinical trials for Avandia included many foreign trial sites, which were submitted in support of the drugs’ application to enter and remain on the U.S. market.  GlaxoSmithKline, the trial’s sponsor, has not been accused of fraud.

According to recent regulatory filings, the following companies are under investigation for possible violations of the FCPA:

• Merck is cooperating with a federal investigation of company activities in multiple foreign nations.
• Medtronic is cooperating with investigations of company activities in Greece, Poland, Germany, Turkey, Italy, and Malaysia.
• Eli Lilly is cooperating with the investigations of subsidiaries in several countries, including Poland.
• Federal investigators are looking into improper payments related to the sale of Zimmer products abroad.
• Johnson & Johnson voluntary disclosed the possibility that company subsidiaries abroad had made improper payments to government officials in two countries relating to the sale of medical devices.
• Pfizer and Bristol-Myers Squibb have also disclosed that they are subject to federal investigations. AstraZeneca, GlaxoSmithKline, and Baxter SciClone have also received inquiries from federal enforcement agencies.

How Much Does PPACA Really Benefit Women?

A recent article by the Commonwealth Fund entitled Realizing Health Reform’s Potential: Women and the Affordable Care Act of 2010¸forecast that “over the next decade, the Affordable Care Act (ACA) is likely to stabilize and reverse women’s growing exposure to health care costs.”  However, a review of the claimed benefits shows that many are equally important to men and women.

Such claims of gender-specific benefits without statistical support are also available from the White house.  That being said, there are some provisions that will greatly benefit women — and to supporters’ detriment — have not received the focus that they should.

Intended Benefits

Several portions of PPACA are intended to benefit women.  The prohibitions against gender-based insurance denials or premium pricing are aimed at combating blatant gender-discrimination in the insurance market.  7.3 million women (38%) in the individual insurance market reported that they were turned down, charged a higher price, or had a preexisting condition excluded from coverage (see graphic below).  As the White House reports, “Right now, a healthy 22-year-old woman can be charged premiums 150 percent higher than a 22-year-old man.”  Such gender-based rating is allowed in 42 states, with some plans charging women as much as 84% more than men for the same age group.  As Secretary Sebelius phrased it, “[b]eing a woman is no longer a pre-existing condition!”

S. Collins, S. Rustgi, and M. Doty, Realizing Health Reform’s Potential: Women and the Affordable Care Act of 2010, The Commonwealth Fund, July 2010.

The essential benefits standards require insurers to cover maternity care, eliminating previously reported pregnancy-discrimination.  Only 13 percent of plans sold in the individual market provide maternity benefits and “in 22 states, no plan covered costs related to pregnancy.”  Other plans impede access to maternity benefits by placing severe limits on costs covered or implementing long waiting periods before coverage begins.

Other services that must be covered by all non-grandfathered health plans beginning September 2010 include:

• Breast cancer screening every one to two years for women age 40 and older
• Cervical cancer screening
• Genetic counseling for the breast cancer (BRCA) gene
• Osteoporosis screening for all women 65 and older, and 60 and older for those at high risk
• Aspirin to prevent cardiovascular disease in women ages 55 to 79

PPACA has several other provisions focused on breast cancer–including, “a special provision directed at raising awareness of, and increasing screening for, breast cancer in young women,” and a directive to pursue breast cancer prevention research in younger women.

Section 4207 of PPACA amends Section 7 of the Fair Labor Standards Act (”FLSA”) by requiring employers to provide “reasonable break time for an employee to express breast milk for her nursing child for 1 year after the child’s birth each time such employee has need to express the milk… [in] a place, other than a bathroom, that is shielded from view and free from intrusion from coworkers and the public…”  The Department of Labor Fact Sheet #73 further explains that a space temporarily converted or made available will be sufficient.

Unintended Benefits

The ban on pre-existing conditions exclusions will remedy a number of  unfair and discriminatory insurance industry practices. It will benefit women in the eight states and District of Columbia where insurers may legally reject a woman’s application on the basis of her prior experience as a victim of domestic violence.  It will also benefit women who would have been previously denied, on the basis of a previous cesarean section, either future C-sections or health insurance as a whole.

Also, the phase-out of the “doughnut hole” coverage gap in the Medicare prescription drug benefit )Part D) will incidentally help more women than men.  Of the 16% of Medicare beneficiaries that reach the doughnut hole each year, women (along with Alzheimer’s and diabetes patients) are the most likely to reach the gap in coverage.

Benefits for Men

So how do men benefit from PPACA?  For starters more men will benefit from the extended health insurance coverage mandated by PPACA.  Although women comprise 60% of adult Medicaid beneficiaries (in 2006), 54.6% of all uninsured are men (in 2007-2008).  The Medicaid safety net has caught more women than men.  However, that is a completely different social discussion to be had another day.

*Note: uncited statistics can be found in the Commonwealth Fund article, S. Collins, S. Rustgi, and M. Doty, Realizing Health Reform’s Potential: Women and the Affordable Care Act of 2010, The Commonwealth Fund, July 2010.

New Rules for Insurance Appeals Under PPACA

On July 22, the Obama Administration released interim final rules that allow patient appeals of health insurance coverage decisions as required under the Patient Protection and Affordable Care Act (”PPACA”) and Health Care and Education Reconciliation Act (”Reconciliation Act”).  Published by the departments of Health and Human Services, Treasury, and Labor, these rules create standards for the internal and external processes by which patients can appeal adverse benefits decisions.

Prior to these rules, coverage appeals were governed by contract and State law.  Forty-four States have created some form of external appeal process for insurance coverage decisions; however, their coverage is limited and the processes vary greatly.  Effective January 1, 2003, changes to the Employee Retirement Income Security Act of 1976 (”ERISA”) regulations provided standards for internal appeals processes.  However, these standards only apply to employer-sponsored group health insurance.

As stated in the Obama Administration fact sheet entitled, “Appealing Health Plan Decisions,”

Today, if your health plan tells you it won’t cover a treatment your doctor recommends, or it refuses to pay the bill for your child’s last trip to the emergency room, you may not know where to turn. Most health plans have a process that lets you appeal the decision within the plan through an “internal appeal” — but depending on your State’s laws and your type of coverage, there’s no guarantee that the process will be swift and objective. Moreover, if you lose your internal appeal, you may not be able to ask for an “external appeal” to an independent reviewer.

Internal Appeals Process

Under the rules, new health plans beginning on or after Sept. 23, 2010, must have an internal appeals process for beneficiaries to challenge “adverse benefits decisions” — a “denial, reduction, or termination of, or a failure to provide or make a payment (in whole or in part) for a benefit.”  Such adverse benefits decisions may be based on individual eligibility, benefit coverage, limitations on otherwise covered benefits (such as preexisting condition exclusions, source-of-injury exclusions, and network exclusions), and a determination that a benefit is experimental or not medically necessary.

In addition, health plans must do the following:

• Notify a claimant of a benefit determination as soon as possible;
• Provide claimants, free of charge, with the evidence relied upon and the rationale for the decision;
• Avoid conflicts of interest by making decisions regarding hiring, compensation, termination, and promotion independent of a claims adjustor or medical experts record of denial of benefits; and
• Meet additional requirements for notice, including information on internal appeals and external review processes.

However, these requirements do not pertain to so-called “grandfathered health plans” — those health plans that were in existence before March 23, 2010 when PPACA was enacted.  In the individual market, health insurance providers must meet the foregoing requirements as well as the following three:

• Applicants for individual insurance must be allowed to appeal initial eligibility determinations;
• Internal review must be limited to a single level, allowing claimants to appeal to external or judicial review immediately; and
• Insurers must maintain all claims and notices for a minimum of six years, which is already required of employer-sponsored health plans under ERISA.

External Appeals Process

If the internal appeal is denied, patients may choose to have the claim reviewed by an independent reviewer.   According to Appealing Health Plan Decisions, States are encouraged to adopt the National Association of Insurance Commissioners (NAIC) standards in “their external appeals laws to adopt these standards before July 1, 2011.”

The NAIC standards call for:

• External review of plan decisions to deny coverage for care based on medical necessity, appropriateness, health care setting, level of care, or effectiveness of a covered benefit.
• Clear information for consumers about their right to both internal and external appeals — both in the standard plan materials, and at the time the company denies a claim.
• Expedited access to external review in some cases — including emergency situations, or cases where their health plan did not follow the rules in the internal appeal.
• Health plans must pay the cost of the external appeal under State law, and States may not require consumers to pay more than a nominal fee.
• Review by an independent body assigned by the State. The State must also ensure that the reviewers meet certain standards, keep written records, and are not affected by conflicts of interest.
• Emergency processes for urgent claims, and a process for experimental or investigational treatment.
• Final decisions must be binding so, if the consumer wins, the health plan is expected to pay for the benefit that was previously denied.

If State laws don’t meet these standards, consumers in those States will be protected by comparable Federal external appeals standards.

As Kaiser Health News reported, “This is a regulation that benefits everyone — consumers get protections, business and providers get more certainty in the rules and the need for litigation to settle these issues should be dramatically minimized,” Phyllis Borzi, assistant secretary of the Department of Labor, said at a briefing for reporters Thursday.

Consumer Assistance Grants

However, procedural rights for consumers are not sufficient to ensure proper appeals.  “Not enough consumers know this is an option that they have,” said Angel Robinson, the consumer advocate in the Iowa Insurance Division, according to Kaiser Health News.

In addition to the new requirements for internal and external appeals processes under the interim final rules, the federal government is offering nearly $30 million in resources to States and Territories to strengthen and establish consumer assistance programs.  Specifically, these programs are charged with:

• Helping consumers enroll in health coverage;
• Helping consumers file complaints and appeals against health plans;
• Educating consumers about their rights and empowering them to take action; and
• Tracking consumer complaints to help identify problems and strengthen enforcement.

Image Credit: Appeal to the Great Spirit, Cyrus Edwin Dallin (1909) Photo by Toni To via Flickr

The Community Health Data Initiative Launched

[Ed. Note: HRW is pleased to introduce Katherine Matos to the blog. Katherine is a 3^rd year student at Seton Hall Law and the principle inventor on a patent application in the field of medical imaging, resulting from her research as a student at Stevens Institute of Technology, from which she  graduated with degrees in biomedical engineering and history. She has published work in Health Law Outlook and now serves as an Editor. Read more]

On June 2, Health and Human Services (HHS) Secretary Kathleen Sibelius and Institute of Medicine (IOM) President Harvey Fineberg launched the Community Health Data Initiative (CHDI) at the IOM sponsored Community Health Data Forum in Washington.[i] The CHDI resulted from a March 11 roundtable between HHS and IOM regarding HHS health data usefulness in developing consumer-based electronic health care applications.[ii] As one of five HHS Flagship initiatives, the CHDI is a public-private effort to “help Americans understand health and health care performance in their communities — and to help spark and facilitate action to improve performance.”

Ultimately, a network of community health data suppliers (beginning with HHS) and data appliers (private innovators) will work together to create applications that:

“(1) raise awareness of community health performance,

(2) increase pressure on decision makers to improve performance, and

(3) help facilitate and inform action to improve performance.”

U.S. Department of Health & Human Services, HHS Open Government Plan, page 60, April 7, 2010, available at http://www.hhs.gov/open/plan/opengovernmentplan/ourplan_openhhs.pdf.

To begin the process, HHS will launch a new online Health Indicators Warehouse by the end of the year to provide the public with community health data, free of charge or any intellectual property constraint.[iii] “In every science-based endeavor, data are the key to the effective action,” said Dr. Fineberg at the Community Health Data Forum. “We need to make more creative and vigorous use of the data we generate now, and we need to create a demand-and-use cycle that will bring about even better information in the future.”[iv] While the National Center for Health Statistics continues to develop the Health Indicators Warehouse, an interim site with one downloadable data set has been made available on the CDC website.

When completed, hundreds (ultimately, thousands) of measures of health care quality, cost, access and public health will be downloadable in a standardized, structured format. “National, state, regional, and county health performance  on indicators such as rates of smoking, obesity, diabetes, access to healthy food, utilization of health care services” will be accessible in a single location.[v] Also, users will be able to sort data according to age, gender, race/ethnicity and income where available.

HHS is committed to personal privacy protection and confidentially “as a fundamental principle governing the collection and use of data.” In any public data releases, individual identifiable information will be protected. Furthermore, HHS will incorporate new approaches to protect confidentiality while maintaining public access into its data release policies.[vi]

To complete the network, HHS is working with private parties, including technology innovators, researchers, companies, and health advocacy groups to utilize the data and provide feedback.  ”As a nation, we can and should harness the exploding creativity in our information technology and media sectors to help us get the most public benefit out of our data investments,” stated Secretary Sebelius.[vii]

In preparation for the Community Health Data Forum, developers such as Microsoft, Google, and Ingenix created software platforms for the presentation of health data.[viii] The Forum featured demonstrations of Web tools for citizen access to health performance data, dashboards for civic leaders to ascertain and improve community health, an online game for learning local health status facts, an enhanced internet search engine that integrates hospital performance data with search results, and mobile phone applications.[ix]

Finally, White House Chief Technology Officer, Aneesh Copra, announced that the administration would host the 2010 Health 2.0 Developer Challenge with the support of HHS and the CHDI.[x] Health 2.0 will host a series of events including multi-disciplinary “code-a-thons,” culminating in the final Challenge at the Health 2.0 Annual Conference October 6-9, 2010.

References:

U.S. Department of Health & Human Services, HHS Open Government Plan, April 7, 2010, available at http://www.hhs.gov/open/plan/opengovernmentplan/ourplan_openhhs.pdf.

U.S. Department of Health & Human Services, News Release: Putting Data and Innovation to Work to Help Communities and Consumers Improve Health, June 2, 2010, available at http://www.hhs.gov/news/press/2010pres/06/20100602a.html.

Genevieve Douglas, HHS Launches New Data Initiative Focused on Improving Community Health, BNA’s Health Care Daily Report,  June 3, 2010, available at http://news.bna.com/hdln/HDLNWB/split_display.adp?fedfid=17265216&vname=hcenotallissues&fn=17265216&jd=a0c3g8b4c1&split=0.

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[i] U.S. Department of Health & Human Services, News Release: Putting Data and Innovation to Work to Help Communities and Consumers Improve Health, June 2, 2010, available at http://www.hhs.gov/news/press/2010pres/06/20100602a.html.

[ii] Genevieve Douglas, HHS Launches New Data Initiative Focused on Improving Community Health, BNA’s Health Care Daily Report,  June 3, 2010, available at http://news.bna.com/hdln/HDLNWB/split_display.adp?fedfid=17265216&vname=hcenotallissues&fn=17265216&jd=a0c3g8b4c1&split=0.

[iii] U.S. Department of Health & Human Services, News Release: Putting Data and Innovation to Work to Help Communities and Consumers Improve Health, June 2, 2010, available at http://www.hhs.gov/news/press/2010pres/06/20100602a.html. U.S. Department of Health & Human Services, HHS Open Government Plan, April 7, 2010, available at http://www.hhs.gov/open/plan/opengovernmentplan/ourplan_openhhs.pdf.

[iv] Genevieve Douglas, HHS Launches New Data Initiative Focused on Improving Community Health, BNA’s Health Care Daily Report,  June 3, 2010, available at http://news.bna.com/hdln/HDLNWB/split_display.adp?fedfid=17265216&vname=hcenotallissues&fn=17265216&jd=a0c3g8b4c1&split=0.

[v] U.S. Department of Health & Human Services, News Release: Putting Data and Innovation to Work to Help Communities and Consumers Improve Health, June 2, 2010, available at http://www.hhs.gov/news/press/2010pres/06/20100602a.html.

[vi] U.S. Department of Health & Human Services, HHS Open Government Plan, April 7, 2010, available at http://www.hhs.gov/open/plan/opengovernmentplan/ourplan_openhhs.pdf, page 2.

[vii] Genevieve Douglas, HHS Launches New Data Initiative Focused on Improving Community Health, BNA’s Health Care Daily Report,  June 3, 2010, available at http://news.bna.com/hdln/HDLNWB/split_display.adp?fedfid=17265216&vname=hcenotallissues&fn=17265216&jd=a0c3g8b4c1&split=0.

[viii] Genevieve Douglas, HHS Launches New Data Initiative Focused on Improving Community Health, BNA’s Health Care Daily Report,  June 3, 2010, available at http://news.bna.com/hdln/HDLNWB/split_display.adp?fedfid=17265216&vname=hcenotallissues&fn=17265216&jd=a0c3g8b4c1&split=0.

[ix] U.S. Department of Health & Human Services, News Release: Putting Data and Innovation to Work to Help Communities and Consumers Improve Health, June 2, 2010, available at http://www.hhs.gov/news/press/2010pres/06/20100602a.html

[x] Genevieve Douglas, HHS Launches New Data Initiative Focused on Improving Community Health, BNA’s Health Care Daily Report,  June 3, 2010, available at http://news.bna.com/hdln/HDLNWB/split_display.adp?fedfid=17265216&vname=hcenotallissues&fn=17265216&jd=a0c3g8b4c1&split=0.

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