As details of health reform policies shake out, questions, answers and consequences are emerging.

Kaiser Health News: The new health care law could shift billions in Medicaid drug rebates from states to the federal government by changing how the rebates are treated. "Democrats included a provision in the health law designed to raise $38 billion over 10 years by requiring greater discounts from drugmakers selling to Medicaid, the joint federal-state health insurance program for the poor. Previously, the rebates were divided between the states and the federal government. Under the law, a significant portion of the rebates will go solely to Washington beginning this year." The law will increase minimum rebates to around 23 percent from 15 percent for brand name medications and generic medication rebates would also be increased. Some rebate losses from states could be offset by a provision in the law that would require drugmakers to provide discounts to states for drugs that are sold to Medicaid managed care plans hired by states, but "California, for instance, stands to lose $50 million next year alone because of the changes, according to Toby Douglas, the state's deputy Medicaid director" (Weaver, 4/20).

In the meantime, a question over a possible lapse in coverage for lawmakers because of the new health law has been resolved, The Washington Post reports. "The issue was highlighted in a recent Congressional Research Service report, which said a possible 'drafting error' in the legislation left unclear the date by which lawmakers and certain staff members will be required to drop their existing insurance and sign up for state-run exchanges that the law will create for people who lack coverage through their jobs." The CRS said that it was possible that because exchanges wouldn't start until 2014, that some lawmakers and staff would be kicked from their insurance, the Federal Employees Health Benefits Program and without an alternative. "But the Office of Personnel Management has concluded that the section of the law forcing them into the exchanges doesn't take effect until the exchanges become operational and that no one will lose his or her insurance" (Markon, 4/21).

"Most definitely!"

The damage now done by the FDA is not fundamentally a result of outright disapprovals of worthy submissions. It has much more subtle origins that fall into two huge buckets with respect to valuable innovations: (a) Long delays and (b) Suppression. The effect is to deprive or delay many patients of access to innovations that will improve health care and help reduce its costs for the benefit of society and the economy as whole. Fundamental change is needed in the dynamics, incentives, and behavior of the FDA and its staff. Understanding the need for this change and then implementing it effectively will require a new, more mature mindset. We must recognize that life is inherently risky, and choices in health care are not subject to the same constellation and power of the free market forces as choices of consumer goods and other services.

 Furthermore bad things can happen for which no one is to blame. This gives way to expensive litigation – damages and compensation for the harm that the few may sometimes suffer. The costly process has forced many organizations to forego risky innovation. These healthcare products that mostly bring huge health benefits to patients and even save much greater numbers from suffering and disease should be guarded from adversarial and expensive law suits, and ultimately supported by health insurance coverage. The Government including the FDA has vital and positive, more innovation-friendly roles to play in this transformation, as do many private sector players. Even we as consumers and patients must support this change. It is high time we rejected the misrepresentations by narrowly motivated ideologues and well-financed special interests groups. We cannot allow the continuation of folks that seek to characterize every such role as a slippery path towards socialized (and/or un-American) medicine and government run health care. These misguided appeals to American exceptionalism obscure and do not shed light on either the difficult choices or the positive opportunities we face. These groups fail to acknowledge the noticeably poorer aggregate outcomes of the U.S. health care system than its counterparts in a few dozen other countries.

Does anyone agree that the status quo is neither acceptable nor tenable over the next generation?