A Medical Device Daily

The Advanced Medical Technologies Association (AdvaMed; Washington) issued a statement last week praising the introduction of legislation in the U.S. House of Representatives designed, it said, “to knock down the barriers patients and their physicians face accessing new diagnostic laboratory tests needed to make informed healthcare decisions.”

The bipartisan Advanced Laboratory Diagnostics Act of 2006 is sponsored by Rep. Michael Ferguson (R-New Jersey), Rep. Phil English (R-Pennsylvania), Rep. Mike Thompson (D-Illinois), and Rep. Bobby Rush (D-Illinois).

“This important legislation will begin to bring the 22-year-old Medicare payment system in line with 21st Century medical science,” said Stephen Ubl, AdvaMed president and CEO. “With breakthroughs in molecular diagnostic testing increasing our ability to preempt and more precisely treat disease, our society cannot afford to have outdated Medicare payment policies standing in the way of these advances.”

Ubl said, “the time is right for Congress to consider and pass this legislation. The Institute of Medicine, The Lewin Group, and the HHS Secretary's Advisory Committee on Genetics, Health and Society have all concluded that the current system is flawed, complex and does not efficiently incorporate new technologies.”

He added: “The stakes are high because Medicare poses significant barriers to patient access to new clinical diagnostic lab tests, reaching far beyond its 42 million beneficiaries because Medicaid and private health insurers often follow Medicare's lead when setting new test payment levels.”

Ubl said that failing to recognize new tests which offer greater benefits to patients and physicians, the current Medicare Clinical Laboratory Fee Schedule provides few incentives for laboratories and healthcare providers to adopt new tests.

Medicare reimbursement for an advanced viral load test for Hepatitis C illustrates the problem with this flawed system, according to Ubl. Medicare reimburses laboratories that offer the Hepatitis C viral load test less than the cost of performing the test and only half the amount of performing an HIV viral load test, which requires an identical series of complex steps and resources.

Hepatitis C viral load testing measures the amount of virus in the patient's blood and helps the physician determine the effectiveness of drugs used to treat the disease, which affects nearly 4 million people in the U.S.

Ubl called Medicare's system “outdated” because it does not consider the technological sophistication of a new test, the resources required to run it and the value of the test to patient care. The bill will reform Medicare policies that discourage the development and adoption of new clinical diagnostic laboratory tests.

Its provisions aim to:

  • Establish a demonstration project to evaluate a new Medicare payment system for molecular diagnostic tests designed to reflect the value of these important technologies to patient care management, potential to reduce long-term health care costs and ability to improve overall healthcare efficiencies;
  • Improve current processes for obtaining adequate reimbursement for new clinical diagnostic tests;
  • Provide more transparency with respect to Medicare reimbursement; and
  • Afford timely correction of historic payment errors.

“Advances in diagnostic lab testing are propelling our ability to personalize medical care to a level unforeseen in 1984, when the current Clinical Laboratory Fee Schedule was created,” said Ubl. “As medical science evolves, so must the Medicare program, and this legislation will allow the program to test a way to better account for the technological sophistication and increasing value of diagnostic lab testing to patient care.”

New research published in the May 11 edition of the New England Journal of Medicine establishes that almost every medical malpractice suit filed in the U.S. has “a meritorious basis and rejects claims that the civil justice system is inundated with frivolous lawsuits,” according to a statement released by the Association of Trial Lawyers of America (ATLA; Washington).

“This study, conducted by the independent and highly-respected Harvard School of Public Health, shows that efforts to implement a one-size-fits-all cap on non-economic damages in medical malpractice cases simply is unnecessary and merely a ploy by the insurance industry to pad their profit margin,'' said Ken Suggs, ATLA president. “If anything, the research establishes that the system is advantageous to big insurance companies and biased against injured patients.”

According to the association, the Harvard study found that most malpractice cases “are meritorious,” with 97% involving injury, and 80% of the claims involving physical injuries resulting in major disability or death.

The study noted, the association said, “that the incidence of patients seriously injured as a result of medical negligence who don't receive compensation is a far larger problem than cases where substantial monetary damages are awarded. It also maintains the civil justice system does a good job of uncovering trivial claims and having them dismissed.

“The research supports the wisdom displayed by the U.S. Senate [last] week when it rejected an attempt to apply a $250,000 cap on non-economic damages in medical malpractice cases.”

“This study disproves once and for all claims made by large insurance companies that the civil justice system is overrun with frivolous litigation,” Suggs said. “The attacks by the insurance industry represent a ploy to further enrich itself at the public's expense.”

ATLA bills itself as being the world's largest trial bar.