The American Society of ClinicalOncology recently urged Congress to pass the Medicare Cancer Clinical Trials Coverage Act without delay.
The bipartisan bill, reintroduced in the Senate by Senators Connie Mack (R-FL) and Jay Rockefeller (D-WV), would establish a demonstration project to guarantee Medicare beneficiaries coverage of routine patient care costs in cancer clinical trials. Similar legislation has been introduced in the House by Representatives Johnson and Cardin.
“Clinical trials advance both patient care and cancer research,” said John R. Durant, MD, executive vice president of ASCO. “Without them, we would not have new drugs to treat cancer, nor would we be able to provide state-of-the-art care to cancer patients.”
Currently, the Medicare program’s policy regarding clinical trials coverage is confusing and inconsistent, leaving patients in a state of uncertainty and fear about whether necessary care offered in a trial will be reimbursed. Even though federal regulations state that Medicare will cover usual patient care costs provided in research settings, some Medicare carriers deem such care “experimental” and therefore deny coverage. Any denials are disastrous to patients whose best available treatment option is in a clinical trial.
“Only through clinical trials can advances in basic research be translated into improved therapies for individuals with cancer,” said Dr. Durant. “Barriers to participation in peer-reviewed trials, including insurance denials as well as the perceived threat of such denials, must be eliminated.”
Because over one half of all cancers are diagnosed in persons age 65 or older, it is critical that this population be well-represented in cancer research. Unless senior citizens are included in clinical trials, research results cannot take into account the potentially different effects cancer and cancer treatments have on their bodies.
“Denying Medicare beneficiaries access to clinical trials is discriminatory and may call into question the validity of clinical trial results as applied to this age group,” said Dr. Durant.
A 70-year-old man with a history of localized prostate cancer treated with whole-pelvis radiation therapy with a boost to the prostate, in conjunction with androgen deprivation therapy 7 years prior, presented with lower back pain. A bone scan revealed an area of activity in the sacrum. What is the most likely diagnosis?
