So my children think this is weird, but I was really happy yesterday because CMS issued the final regulations on Section 1115 waivers. CMS also issued final rules on so-called “State Innovation” waivers that will be available through the Affordable Care Act, but since those don’t go into effect until 2017 we will come back to that in a future blog post.

As part of the Affordable Care Act, Congress required that CMS develop new regulations on Section 1115 waivers because of widespread concern over a high stakes process that often lacked transparency. Proposed regulations were issued in September 2010 that CCF and the Center on Budget and Policy Priorities with a number of other groups submitted comments on at that time. Now, we finally get to take a look at the final product. Overall, the rule could be stronger in places, but incorporates many of the important features we had hoped for.

Some of the key elements of the new rule include a 30-day public comment process at both the federal and state levels on a state’s application for a new waiver request or extension of an existing demonstration project. Importantly, the rule specifies that the public must have a “sufficient level of detail to ensure meaningful input” for the public comment process. In the past, states have often not offered up enough detail to the public to allow for meaningful input. For example, the regulation specifies that the application must include a description of the specific populations that will be affected, projected enrollment changes for each population, expenditure changes and the particular provisions of federal law that the state is seeking to waive. A state seeking a waiver to respond to a natural disaster or public health emergency could seek a waiver of the public comment processes.

Materials must be publicly available on state websites and the state must also hold at least two public hearings where there is an opportunity to give comment. These hearings could be done by using at least two of the following forums: a meeting of the state’s Medical Care Advisory Committee, a commission with open meetings, the legislative process or another process. Tribes must also be consulted with prior to application submission.

One of my favorite provisions includes the requirement that a state must show how it has considered the public comments it has received upon submission of the final application.

The new rule also includes sections on monitoring and evaluating the demonstrations once approved. Section 1115 is, after all, research and demonstration authority that was established to allow states to test new and innovative ideas. A credible evaluation has been lacking in many Section 1115 waivers.

CCF will be preparing a more comprehensive summary of the new rules, which become effective on April 22nd, and we will let you know when that is ready.

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