On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
CMS Finalizes Blueprint for State-Based and Partnership Health Insurance Exchanges
The Center for Consumer Information and Insurance Oversight (CCIIO) within the Centers for Medicare & Medicaid Services (CMS) finalized its instructions to states seeking federal approval to establish a State-based Health Insurance Exchange or participate in a State-Federal Partnership Exchange in its Blueprint for Approval of a State-based or Partnership Exchanges. The Final Blueprint, issued on August 14, 2012, changed very little from the Draft Blueprint previously released on May 16, 2012.
According to this guidance, each state wishing to establish a State-based or Partnership Exchange must submit a Blueprint made up of two components:
- A Declaration Letter; and
- An Exchange Application.
Declaration Letter: The Declaration Letter must state the type of Exchange model that the state intends to pursue (i.e., State-based or Partnership Model). Declaration letters are optional for states seeking to participate in a Federally-Facilitated Exchange (FFE). HHS will plan to operate an FFE in any state that has not submitted a Declaration Letter by November 16, 2012. To date, approximately a dozen states have submitted Declaration Letters confirming their intent to operate State-based Exchanges.
Exchange Application: The Exchange Application includes a detailed list of requirements or activities that a State-based Exchange or Partnership Exchange must perform (or in some cases, may rely on the federal government to perform) in order to be approved under the Patient Protection and Affordable Care Act (PPACA), such as:
(1) Legal authority enabling the Exchange and the Exchange governance structure;
(2) Consumer engagement such as outreach, call centers, web site, navigators, and agents/brokers;
(3) Eligibility and enrollment; and
(4) Plan management functions, such as certification of Qualified Health Plans (QHPs), oversight, and quality reporting.
The Exchange Application must include an attestation that each activity has been completed or, if completion is expected, a timeline and work plan for meeting the requirements. Supporting documentation is required for some of these activities. The Exchange Application must be completed online and will be available beginning September 14, 2012 on CCIIO’s State Exchange and Virtual Information System.
Deadline for Submission: For plan year 2014, the complete Exchange Blueprint must be submitted by November 16, 2012. The Department of Health and Human Services (HHS) then has until January 1, 2013 to approval the Exchange.
Approval or Conditional Approval: HHS will approve State-based and Partnership Exchanges once the state has adequately demonstrated its ability to perform all of the required Exchange activities. HHS will issue a “Conditional Approval” to states that have not yet met all of the Exchange requirements but are showing significant progress towards doing so and will be operationally ready by the open enrollment period start date of October 1, 2013 (for plan year 2014). CMS will work with those states that receive Conditional Approval to establish timelines and milestones to ensure that the state satisfies the applicable Exchange requirements by October 1, 2013.
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