A Diagnostics & Imaging Week

After more than a decade of attempts, it looks like Congress might finally pass a bill that would block health insurers from denying coverage to otherwise healthy persons based on their genetic predisposition to come down with a particular disease.

The bill, the Genetic Information Nondiscrimination Act (GINA), also would bar employers from using genetic information as part of hiring, firing, job placement or promotions.

The 95-0 Senate vote sends GINA back to the House, which could approve it this week. President George Bush supports the legislation.

The House approved the bill last year on a 420-3 vote, but now must reconcile its version with that of the Senate, which inserted changes that attempt to make the bill easier on insurers. The changes are a concession to Sen. Tom Coburn (R-Oklahoma), who had blocked the bill, arguing that it could impose unintended liability risks.

The Senate compromise, worked out earlier this week tightens language to ensure that there is a "firewall" between the part dealing with health plans and the section regarding employment, so as to discourage inappropriate claims.

The Senate passed genetic nondiscrimination bills on unanimous votes in 2003 and 2005 but couldn't get the House to act.

If this bill passes, it could have important implications for the future of personalized medicine. Currently, some researchers studying gene-specific effects of treatments are finding that some subjects won't participate due to fears that their data will be used against them at some future date.

"For the first time, we act to prevent discrimination before it has taken firm hold and that's why this legislation is unique and groundbreaking," said Sen. Olympia Snowe (R-Maine), who sponsored the Senate bill with Sens. Ted Kennedy (D-Massachusetts) and Mike Enzi (R-Wyoming).

There are more than 1,100 genetic tests available today, she said, but these are "absolutely useless" if fear of discrimination discourages people from taking tests or participating in clinical trials, Snowe said.

It is believed that genetic testing could lead to early, lifesaving therapy for a wide range of diseases with hereditary links such as breast and prostate cancer, diabetes, heart disease and Parkinson's disease.

Several groups echoed Snowe's enthusiasm for passage of the bill.

"We are very pleased that GINA is close to enactment," said Edward Abrahams, executive director of the Personalized Medicine Coalition (Washington). "The guarantees provided by this legislation will encourage millions of Americans to use their genetic information to improve their healthcare, and to help prevent and treat cancer and other diseases. We urge President Bush to sign GINA into law."

"Passage of GINA comes at a critical time, when the potential for discrimination is growing as more genetic tests are becoming available," said Stephen Fodor, CEO of Affymetrix (Santa Clara, California), which makes the GeneChip microarray technology used for analyzing complex genetic information to enable scientists to develop diagnostics and tailor treatments for individual patients "We will look back at this time as a historic turning point in the evolution of medicine."

GINA closes important gaps in the current patchwork of federal and state protections against the misuse of genetic information. Current federal statutes for protecting medical information, including the Health Insurance Portability and Accountability Act, do not prohibit insurers from requiring genetic testing or from denying coverage based on genetic information. And while the Americans with Disabilities Act protects individuals with symptomatic genetic disabilities, it is not clear if it explicitly covers discrimination based on unexpressed genetic susceptibility to disease.

Only a few states have strong protections against genetic discrimination, leaving some individuals more vulnerable depending on where they live.

Data backs routine Medicare coverage of PET

Proponents of increased Medicare coverage of scanning services may work in the mode of attrition, and a recently reopened national coverage analysis (NCA) seems to work in precisely that way.

Thanks to a decision to apply the coverage with evidence development (CED) reimbursement rubric to the use of positron-emission tomography (PET), the Centers for Medicare & Medicaid Services has reopened an NCA for FDG (fluorodeoxyglucose) PET usage in detection of several cancers, including cervical, ovarian, testicular and pancreatic cancers.

This is the third review of the matter since the beginning of the decade, and on this occasion, the review came at the request of the National Oncologic PET Registry (NOPR; Philadelphia). In a March 25 letter to the agency, Bruce Hillner, MD, who chairs NOPR, and three co-chairs stated that data "collected over the past 18 months" on almost 23,000 individual cases provides "strong empirical evidence to justify a decision to end the CED requirements . . . and to support a Medicare coverage policy for PET across all cancer types" for diagnosis and staging. The data indicate that more than "one-third of patients undergoing PET for one of the cancer types . . . had a major change in intended management, including type of treatment."

The authors of the NOPR letter acknowledge a lack of evidence to support "coverage of PET for treatment monitoring," but the registry will accumulate further data to address this use.

The most recent decision memo, dated Jan. 28, 2005, concluded that "there is sufficient evidence to conclude that an FDG PET scan for the detection of pre-treatment metastases (i.e., staging) in newly diagnosed cervical cancer subsequent to conventional imaging . . . is reasonable and necessary as an adjunct test."

The agency stated that for the other cancers, "an FDG PET scan is reasonable and necessary only when the provider is participating in and patients are enrolled" in an IDE trial or a trial "designed to collect additional information at the time of the scan to assist in patient management."

Previous coverage decisions have indicated reimbursement for roughly 30 uses, including initial staging and diagnosis of lung and colorectal cancers. CMS will take public comments through May 10 and will offer a proposed decision memo by Oct. 10.

Heartsbreath test finally gets a look

The Centers for Medicare & Medicaid Services is finally taking a look at coverage for the Heartsbreath test from Menssana Research (Fort Lee, New Jersey), a diagnostic that measures the amount of methylated alkanes in a patient's breath to determine the probability of rejecting a transplanted heart.

Michael Phillips, MD, president of Mensasnna, filed the current request in November 2006, stating in a letter to the agency's director of coverage analysis that his first meeting with CMS personnel on the question was in 2004, when he was informed that "CMS was not considering NCDs with HDE [humanitarian device exemption] approval from FDA."

After two years of working with local Medicare carriers, "I have now come back full circle to CMS," he said, asking that the agency "review this application expeditiously."

CMS accepted the request April 10 and expects to propose a decision memo by Oct. 10.

Among the local carriers Mensanna struck out with was Anthem Blue Cross/Blue Shield of Wisconsin (Waukesha), which gave the application a "no" vote last May, citing inadequate data for scientific conclusions regarding the test's clinical utility.

CMS said that the Heartsbreath test "may predict the probability of grade 3 rejection in heart transplant recipients who received their transplants in the preceding year." If adopted, it would replace endomyocardial biopsy, but "the use of the device is [currently] limited to patients who have had endomyocardial biopsy within the previous month." Public comments will be accepted through May 10.