A Medical Device Daily

The Centers for Medicare & Medicaid Services has confirmed that it will not authorize payment for the Heartsbreath test, manufactured by Menssanna Research (Newark, New Jersey) after determining "that the evidence does not adequately define the technical characteristics of the test nor demonstrate that Heartsbreath testing to predict heart transplant rejection improves health outcomes."

Menssana had proposed coverage of the diagnostic in 2006, but had difficulty in gaining traction with the agency until last year, when CMS opted to look the proposal over (Medical Device Daily, April 30, 2008). The agency's proposed coverage decision was posted in October (Medical Device Daily, October 23, 2008), and nothing happened in the interim to change the agency's thinking.

The Heartsbreath test, as the name suggests, detects volatile organic compounds (VOCs) in the breath of patients who have undergone a heart transplant, which Menssana proposed served as an index of tissue rejection.

According to CMS's earlier postings, the pivotal PMA study for the Heartsbreath, the HARDBALL (Heart Allograft Rejection; Detection with Breath Alkanes in Low Levels) study did little to suggest the usefulness of a determination of grade 3 tissue rejection, "especially given the controversy in the transplant community regarding what grade of rejection should indicate a change in clinical management." CMS also had reservations over the utility of the VOCs as biomarkers of rejection, stating in the proposed decision memo of October that "it is unclear if these specific VOCs are representative of grade 3A rejection in all patients or are representative of only the sample of patients" in the study.

The application certainly did not fail for lack of effort. Michael Phillips, MD, President of Menssana, wrote in a Nov. 18, 2006, letter to CMS that he'd had no luck with local coverage contractors "in several states, particularly in New York and New Jersey" after being advised to pursue such a course by administrators at CMS. After efforts he described as "ultimately fruitless," Phillips said "I was ultimately told that I should now return to CMS in order to pursue an NCD." Hence, "I have therefore now come full circle back to CMS."

Phillips had not responded to calls for comment at press time.

Massachusetts model blasted as failure

Critics of healthcare reform that comes up short of a single-payer system have taken aim at the healthcare reforms in Massachusetts and decry the effort in the Bay State as a failure. According to a Feb. 20 statement released by Physicians for a National Health Program (PNHP; Chicago), the Massachusetts program, "widely regarded as an example of how to provide universal coverage and keep costs low, is in fact faltering badly and should not be held up as a national model for reform."

The statement, released to coincide with a study of the Massachusetts program, also notes that PNHP is among groups that are urging the state's senior member of the U.S. Senate, Ted Kennedy "to introduce single-payer legislation." Whether the idea will float beyond the Senate Health, Education Labor and Pensions Committee, which the Massachusetts Democrat chairs, is unlikely given the stated opposition to single-payer healthcare expressed by Senate Finance Committee chairman Max Baucus (D-Montana).

The statement notes that the mandatory enrollment in the Massachusetts law was less than utterly successful, given that "the state's most recent figures show that it had to exempt 79,000 residents from the mandate in 2007 because they could not afford to buy insurance."

According to the PNHP statement, "many low-income residents, who used to receive completely free care now face co-payments, premiums and deductibles under the new system – financial burdens that prevent many of them from receiving necessary medical treatment." The statement also charges that "premiums under the state insurance program have increased 9.4%" and that "if a middle-income person on the cheapest available state plan got sick, he or she could end up paying $9,872 in premiums, deductibles and co-insurance for the year."

Steffie Woolhandler, MD, a co-founder of the organization, accused "big hospitals and insurers" of getting "rich off reform," and asserted that "a survey shows that more people directly affected by it have been harmed than helped."

Virtual reality bill resurfaces

A bill that would fund more research into virtual reality software for determining the efficacy and safety of drugs and devices has made its way back onto the congressional plate in the form of H.R. 855, also known as the Enhancing Safety in Medicine Utilizing Leading Advanced Simulation Technologies to Improve Outcomes Now Act of 2009. The bill's supporters, Randy Forbes (R-Virginia) and Patrick Kennedy (D-Rhode Island) are confident that medical modeling and simulation (M&S in the jargon) can cut costs and save lives by replicating the real world inside a computer.

Among other things, the bill would mandate the establishment of federal centers of excellence in medical simulation and establish a federal coordinating council for medical simulation. H.R. 855 would authorize $50 million for the upcoming fiscal year to establish the centers of excellence and to fund grants in the field. Forbes and Kennedy drafted a similar bill in the previous congress, although the bill died in committee.

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