Health Insurance Reform & Makena

Long awaited proposed rules that would govern the operation of accountable care organizations (ACOs), with relation to Medicare, were released last week. ACOs have been touted by some as an important step toward building a health care system that better encourages value and quality outcomes for patients. Aetna insurance early experience with the ACO model shows the approach can help improve quality and lower costs. But the proposed rules released by the Department of Health and Human Services (HHS) may now answer some of the questions that have been raised about how ACOs will be allowed to operate. The new entities are specifically authorized for Medicare patients under the Patient Protection and Affordable Care Act (PPACA), and federal officials have predicted that 1.5 million to 4 million Medicare beneficiaries would be involved in the program.

On March 30, the Food and Drug Administration (FDA) moved unusually quickly and decisively to promote the availability of a safe and effective pre-term birth prevention drug at a fraction of the cost of a new competitor drug.  Three weeks ago, the FDA approved a new drug (Makena) to reduce the risk of pre-term births  Access to the then existing, but not officially approved drug known as 17P, was immediately put in jeopardy because doctors and pharmacies did not want to prescribe or dispense an unapproved drug and face sanctions by the FDA or litigation from the maker of Makena. To make matters worse, access to Makena was cost-prohibitive for most women; the full treatment cost for 17P is about $210 while the treatment cost for Makena is roughly $30,000.  Aetna was the lead insurer in an industry-wide, ad hoc coalition formed to fight for some form of relief from the FDA.  The calls, Hill visits, lobbying, white papers and more paid off as the FDA announced March 30 that it would not take action against pharmacies that continue to dispense P17. CMS followed suit minutes later with a directive to the states, supporting the FDA announcement and advising that state Medicaid programs can continue to pay for P17. For Aetna customers, paying for P17 rather than Makena means a difference of millions of dollars annually – with no difference in efficacy. While Aetna is seeking further clarification on the parameters for promoting and advertising the less expensive drug, the FDA decision is truly stunning in its clarity and impact.

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