March 18, 2019

March 18, 2019

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

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  • Removing outdated regulations;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

 

 

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About this Author

Kate Stewart, Mintz Levin Law Firm, Boston, Health Care Law Attorney
Associate

Kate’s practice involves a variety of regulatory and transactional matters for healthcare providers, including hospitals, physician groups, clinical laboratories, retail health clinics, and pharmacies.  

Kate counsels health care clients on HIPAA compliance, telemedicine practice, licensure and scope of practice issues, clinical trial compliance, physician contracting and the federal Physician Payments Sunshine Act. 

For both Covered Entities and Business Associates, she has advised on initial implementation and updates...

617-348-4427
M. Daria Niewenhous, Health Care Tech Attorney, Mintz Levin, HIPAA Lawyer
Member

Daria's practice ranges from transactional matters to general counsel services. She has extensive experience with the merger and acquisition of hospitals, long-term care facilities, clinics, assisted living facilities, home health and hospice programs, group practices, and other provider entities. She guides clients through the regulatory aspects of capital projects and other strategic initiatives. Active in health care reform matters, Daria is currently working with clients on ACO formation, clinical integration and affiliation, and similar arrangements. In addition, Daria provides experienced counsel in areas of contracting, patient care/risk management matters, privacy and security of patient information (HIPAA), and addressing adverse events, including crisis management. 

617-348-4865