State Laws Concerning Clinical Trials and Off-Label Drug Use for Cancer Patients. The type of insurer addressed by the law varies by state.
It is important to build an organizational culture that is prepared to fight back against this statement, Evans repeated during the session.“When told that they do not cover experimental treatment, ask them instead if they cover the routine cost of cancer care,” Evans said.
“Then make the case that routine care is all you are asking them to cover.”In some cases, making a case that trial participation is part of the routine care of the patient can be bolstered by a letter from the treating physicians explaining why the treatment is medically necessary, or by sending medical journal articles that show possible patient benefits from the treatment that is being tested.
After implementation of the coverage policies in 1999 in four states, there was a 21.7% (95% CI = 3.8% to 42.6%) annual increase in phase II trial enrollment in coverage states, compared with a 15.6% (95% CI = 8.8% to 21.8%) annual decrease in noncoverage states (P A PDF file should load here.
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State Cancer Legislative Database Program Kristianna G. Phase II: Study expanded to a larger group (100-300 people) to evaluate effectiveness and safety.
While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. Phase I: Study testing a new drug/treatment for the first time in a small group (20-80 people) to determine safety, safe dosage range, and side effects.
Expanding the evidence base for health care interventions is clearly in the interest of both taxpayers who support Medicare and beneficiaries who receive services.
The impression is widespread that some patient care in clinical trials is not reimbursable under Medicare.
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