Photo of M. Daria Niewenhous

Daria Niewenhous is a Member in the firm’s Boston office. 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 works with clients on ACO formation, clinical integration and affiliation, and similar arrangements.

The Massachusetts Department of Public Health (DPH) has promulgated final Hospital Licensure Regulations.  Approved by unanimous vote of the Massachusetts Public Health Council (PHC) on March 8, 2017, DPH anticipates that the Hospital Licensure Regulations (105 CMR 130.000, et seq.) will be published in the Massachusetts Register in April, 2017.  The regulations will become effective as of the date of such publication.

As noted in our September 26, 2016 Blog Post, the amendments are part of DPH’s overall regulatory review process needed to comply with Governor Baker’s Executive Order 562, which directed all executive branch state agencies to review and, where possible, streamline, simplify and improve regulations.  At Wednesday’s PHC meeting, Commissioner Monica Bharel, M.D., MPH introduced the presentation of the final regulation by senior DPH staff, indicating that the regulation is part of DPH’s public health informed view of system transformation.  In its materials accompanying the presentation of the regulations, DPH noted that the regulation is intended to ensure a high quality of care, industry standardization, and strong consumer protection for persons receiving hospital care.

In response to comments received in response to the proposed revisions, DPH made a number of further revisions to clarify definitions and licensure requirements, streamline administrative and staffing requirements, and remove duplicative and unnecessary reporting requirements (aligning, when possible, reporting requirements of other state agencies).  A summary of comments received, and DPH’s responses to such comments, is contained in the Information Briefing provided to Dr. Bharel and the PHC. Continue Reading Massachusetts Department of Public Health – Final Hospital Licensure Regulations

The Massachusetts Department of Public Health (DPH) Determination of Need (DoN) Program has promulgated final DoN regulations (shown here compared against the draft revisions.)  Approved by the Massachusetts Public Health Council (PHC) on January 11, 2017, DPH anticipates that the DoN regulations (105 CMR 100.000, et seq.) will be published in the Massachusetts Register on January 27, 2017, which will be their effective date.

Commissioner Monica Bharel, M.D., MPH emphasized that the overarching goal of these revisions is to meaningfully infuse public health and population health principles within this longstanding health care regulation. The Commissioner noted that it is her belief that successful cost containment must occur in the context of tackling social determinants of health. Our previous blog post, published at the time the draft revisions were presented to the PHC, reviews in some detail the DoN Program’s public policy goals underpinning these revisions, and we refer you to that post for more information.

At the presentation of the draft revisions to the PHC on August 23, 2016, DPH announced its intent to solicit and encourage robust public comment, and the public did not disappoint. A January 11, 2017 memorandum from senior DPH staff to Commissioner Bharel and members of the PHC requesting approval of the final proposed DoN regulations stated that DPH received over 100 comments, submitted at two public hearings and in writing during the 45-day public comment period. The memorandum summarizes not only the comments received, but the stakeholders who submitted the comments and DPH’s public policy rationale for its reaction to many of the comments. Materials (available here and here) accompanying the presentation of the final proposed DoN regulations also summarize the draft revisions, comments received and final proposed DoN regulations.

Many comments addressed the requirements for DoN review of ambulatory surgery, transfer of ownership, Community Health Initiative (CHI) projects, as well as application requirements, review process and criteria, and standard conditions.  Two areas that generated many of the public comments, and which resulted in adjustments to the proposed DoN regulations, are discussed below.  Continue Reading Massachusetts Determination of Need Program – Final Regulations

Massachusetts Long Term Care Facility Regulations – Proposed Amendments

The Massachusetts Department of Public Health (DPH) continues its efforts to revise its regulations to comply with Executive Order 562, which requires all state agencies to review its regulations. Long-Term Care Facilities (LTCFs) must currently comply with 3 separate regulations: 105 CMR 150.00 (Licensing of Long-Term Care Facilities); 105 CMR 151.000 (General Standards of Construction for LTCFs in Massachusetts); and 105 CMR 153.000 (Licensure Procedure and Suitability Requirements for LTCFs). (Note: these links will bring you to DPH’s redlined versions, where applicable.  The corresponding presentations by DPH staff to the Public Health Council (PHC) at the PHC’s November 9, 2016 meeting are available here.)  Continue Reading Massachusetts Long Term Care Facility Regulations – Proposed Amendments

At yesterday’s Public Health Council meeting, the Massachusetts Department of Public Health (DPH) released yet another round of proposed regulatory amendments.  On deck were regulations concerning Long Term Care Facilities, Hospice Programs, and Temporary Nursing Service Agencies, as well as requirements for Training of Nurses’ Aides in Long-Term Care Facilities.  Also presented were updated regulations on the Drug Formulary Commission (formerly List of Interchangeable Drug Products regulations).  Senior DPH staff presented the proposed regulations, highlighting key objectives. Council members were highly engaged in the discussions, asking numerous questions and offering comments.  Commissioner Monica Bharel, MD, MPH, commended DPH staff for their hard work on the amendments and the Council for its support of these ongoing efforts. Continue Reading Massachusetts Regulatory Overhaul Continues

Continuing our current coverage of health policy issues and trends, Mintz Levin’s Health Law Practice and ML Strategies have issued a joint Alert regarding the Massachusetts Health Policy Commission’s Annual Cost Trends Hearings.  The hearings, which took place on October 17 and 18, provided an opportunity for a wide-ranging discussion of the Commonwealth’s health care system and its rising costs.  The Alert highlights the topics covered over the course of the hearing, and summarizes the points made by the academic, industry, and political leaders who participated. Many of these topics, including pharmaceutical spending, behavioral health, and alternative payment models, are at the core of emerging health policy discussions across the country.  You can read the full alert here.

In previous blog posts, we addressed the Massachusetts Department of Public Health’s (DPH) proposed regulations that affect hospitals, dialysis clinics and medical marijuana programs.  In this final post on DPH’s recent regulatory review and overhaul, we address the proposed amendments to the clinic licensure regulations.  DPH’s presentation to the Public Health Council is available here.  As with the proposed amendments to the hospital and dialysis clinic regulations, many of the changes to the clinic licensure regulations are technical in nature and aimed at reducing the regulatory burden on clinics, aligning reporting obligations with other state and federal Massachusetts requirements and updating regulatory language.  DPH did, however, propose some a number of substantive amendments to the clinic licensure regulations, including the following: Continue Reading Massachusetts Licensure of Clinics Proposed Regulations – Key Take-Aways

The Massachusetts Department of Public Health (DPH) has released for public comment proposed amendments to DPH’s Medical Marijuana Regulations (105 CMR 725) (the “regulations”).  DPH believes that the proposed amendments will streamline the Medical Use of Marijuana Program (the “Program”) by updating existing processes, providing additional clarity, and creating consistency with changes made to related laws, all with the goal of promoting patient access while assuring public safety is maintained.  At a meeting of the Public Health Council (PHC) held on September 14, 2016, DPH representatives, including Program Director Bryan Harter, MBA, LICSW, presented the proposed amendments.  DPH’s presentation to the PHC at the meeting includes a summary of the proposed amendments, as well as a brief history of the Program, including applications received, provisional Certificates of Registration to operate a Registered Marijuana Dispensary (RMD) (41), and number of RMDs currently open and dispensing marijuana for medical use (7).

Amendments are undoubtedly necessary. The current regulations, which became effective on May 24, 2013, were implemented in connection the creation of the Program, and DPH now has the benefit of experience with the RMD process to amend its regulations to reflect, in some cases, lessons learned.  As with proposed amendments to other regulations (see our prior posts here and here), these amendments are also necessary to comply with Governor Baker’s Executive Order 562, which directed all executive branch state agencies to review and, where possible, streamline, simplify and improve their regulations.  Continue Reading Medical Marijuana in Massachusetts – DPH Proposes Amendments to Regulations

The Massachusetts Department of Public Health (DPH) has released for public comment proposed amendments to DPH’s Hospital Licensure Regulations (105 CMR 130.00) (the “regulations”). The proposed amendments are designed to enable the regulations to meet a number of goals, among them ensuring a high quality of care, industry standardization and strong consumer protection for hospital patients. These amendments are part of DPH’s overall regulatory review process needed to comply with Governor Baker’s Executive Order 562, which directed all executive branch state agencies to review and, where possible, streamline, simplify and improve regulations.

The presentation to the Public Health Council (PHC) by attorneys Sherman Lohnes, Director of the Division of Health Care Facility Licensure and Certification, Bureau of Health Care Safety and Quality and Lauren Nelson, the Bureau’s Director of Policy and Quality Improvement, offers a good summary of many of the proposed changes.  This post features several items that are particularly noteworthy. Continue Reading Massachusetts Hospital Licensing Regulations Proposed Amendments – Key Take-Aways

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 Massachusetts Department of Public Health (DPH) Determination of Need (DoN) Program has unveiled proposed regulations that constitute an ambitious and, perhaps, long overdue overhaul of the DoN Program regulations. Attendees at the August 23, 2016 Public Health Council (PHC) meeting were anxious to get their hands on a copy of the much-anticipated proposed regulations, with a queue at the materials table reminiscent of a bookstore at the release of the latest Harry Potter novel.

As noted in the Informational Briefing Memorandum to the PHC, the proposed regulations are designed to revamp the outdated DoN regulations by aligning the DoN process with the Department’s overarching goals and purposes as well as other related processes within state government, including those of the Health Policy Commission (HPC), that are designed to regulate and monitor the Commonwealth’s health care delivery system.   Continue Reading Massachusetts Determination of Need Regulation Overhaul