The Pharmaceutical Research and Manufacturers of America (PhRMA) submitted comments in response to the proposed rule that addresses many topics of great importance both to Medicaid and to our country’s health care system generally. Several of these issues, in fact, could have a central role in shaping the future course of our health care system. Moreover, these proposals could have widespread impacts on the biopharmaceutical marketplace, as they focus on or have repercussions for several government pricing metrics (Medicaid rebate metrics and the Medicaid unit rebate amount, the 340B Program ceiling price and Medicare Part B drug payments). As a result, we are concerned that CMS packaged these issues into one proposed rule with a 30-day comment period, which denies commenters adequate time and opportunity to prepare comments on these issues.