Dr. Michelle McMurry-Heath, president and CEO of the Biotechnology Innovation Organization (BIO), released the following statement in response to the Centers for Medicare and Medicaid Services’ (CMS) proposed National Coverage Determination (NCD) to restrict coverage for drugs used to treat patients suffering from Alzheimer’s: “The announcement by CMS sets a dangerous and far-reaching precedent for patients struggling with Alzheimer’s and other difficult to treat diseases. Limiting coverage only to patients enrolled in government-mandated randomized clinical trials means that most of those suffering from Alzheimer’s would be denied access to an approved medicine simply because of where they live or where they go for care. “The CMS proposal also would require post-approval randomized controlled trials for all future drugs in this class, regardless of the type and volume of evidence demonstrated during FDA-required trials and regardless of whether future drugs are approved during an accelerated pathway or through traditional channels. In essence, through this coverage announcement, CMS is pronouncing its disagreement with FDA’s gold-standard, science-based, safety and efficacy standards.  Surely the first time such a conflict has arisen and now a dangerous rebuke of FDA’s scientific autonomy and decision making. “In the coming weeks, we hope that CMS will reevaluate its proposal in light of the fact that it would restrict access for the most vulnerable patients and adversely impact the future investment needed to develop new medicines to treat patients suffering from Alzheimer’s. “Most Medicare beneficiaries that meet FDA-approval criteria would not be able to access the drug under this proposal. There also is the issue that many enrolled in randomized trials won’t even have access to the drug, since they will be receiving the placebo. In addition, under this proposal, coverage wouldn’t even begin to be available until a trial is approved and enrolling…