ARTICLE
16 September 2016

Massachusetts Regulatory Overhaul: Hospitals, Clinics, Dialysis Units, And Medical Marijuana – Oh My!

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Commissioner Monica Bharel, MD, MPH, commended DPH staff for their hard work on the amendments.
United States Food, Drugs, Healthcare, Life Sciences

The Massachusetts Department of Public Health (DPH) has released proposed amended regulations for the licensure of hospitals, clinics, and out-of-hospital dialysis units, proposed the rescission of separate birth center regulations, and proposed amended regulations for medical marijuana. At a very busy September 14, 2016 Public Health Council Meeting, senior DPH staff presented the proposed regulations, highlighting key objectives and fielding questions and comments from Council members.  Commissioner Monica Bharel, MD, MPH, commended DPH staff for their hard work on the amendments.

In the proposed facility licensing regulations, key themes across all facility types included:

  • Removing outdated regulations;
  • Updating standards to give additional flexibility while protecting patient safety and tying regulatory standards to nationally recognized, evidence-based guidelines;
  • Aligning state and federal requirements; and
  • Providing clearer timelines and guidance for initial license applications, change of ownership or location, and facility closure.

The proposed regulations and the presentations are available below, along with public hearing dates and comment deadlines.  As discussed in a recent post regarding proposed amendments to the Determination of Need Regulations, consistent with Governor Baker's Executive Order 562, DPH is reviewing and, where possible, streamlining, simplifying and improving its regulations. These proposals are sure to generate much discussion and comment.  In the meanwhile, please stay tuned for more detailed posts on these amendments.

Topic Citation Proposed Amended Regulations DPH Presentation Public Hearing Date Comment Deadline
Hospitals 105 CMR 130.00 Link Link October 24, 9:30AM October 28
Clinics 105 CMR 140.000 Link Link October 25, 9:30AM October 28
Dialysis Units 105 CMR 145.000 Link Link October 25, 9:30AM October 28
Birth Centers 105 CMR 142.000 Link Link October 24, 9:30AM October 28
Medical Marijuana 105 CMR 725.000 Link Link

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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