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The Massachusetts Department of Public Health (DPH) recently proposed a revision of DPH’s Determination of Need (DoN) regulations.  At the highest level, this proposed revision represents a paradigm shift to a streamlined and retooled process that puts public health at its core.

In support of this goal, the DoN Program is reviewing and revising DoN sub-regulatory guidelines regarding equipment and services that require DoN review (the Guidelines). The Guidelines will help ensure that low-value, high-cost equipment and services receive an appropriate level of review. At the same time, the Guidelines will help ensure that the regulations do not impose unnecessary oversight for equipment and services that are in fact innovative and are used to add measurable value for Massachusetts consumers.

CLICK HERE: DoN-Required Equipment and Services Listening Session Overview Slides

In line with the proposed regulatory changes, DPH will be eliciting comment and will conduct a listening session to inform development of the Guidelines. The listening session is designed:

  • To assist in developing the list of DoN-Required Services and Equipment referred to in regulation, specifying equipment and services for which DoN review is required;
  • To further define the terms “DoN-Required Service” and “DoN-Required Equipment” by establishing criteria by which DPH evaluates services and equipment for inclusion on the list; and,
  • To help establish an annual process and framework by which the list is reviewed and requests are received for consideration by the Department.

The framework guiding the inclusion of an equipment or service is evidence that the equipment or service does not lead to one or more of the following:

  • Quality: Improved patient panel health outcomes;
  • Access: Increased access, including, but not limited to a decrease in price; or,
  • Cost: A reduction in the Commonwealth’s Total Health Care Expenditure.

Additionally, this framework considers Health Systems Sustainability.

Questions/Comments can be submitted at: through Monday, November 7, 2016. We look forward to your input.

For more information on the proposed DoN revision, please visit:

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