United States: Massachusetts Determination Of Need Regulation Overhaul

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As noted in the Informational Briefing Memorandum to the PHC, the proposed regulations are designed to revamp the outdated DoN regulations by aligning the DoN process with the Department's overarching goals and purposes as well as other related processes within state government,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.  

Reflected throughout the presentation by DoN Program Director, Nora Mann, to the PHC is DPH's overarching goal to bridge the gap between the current DoN regulations that utilize an outmoded health planning process focused on monitoring and controlling costs and expenditures while regulating capacity and access on a geographic distribution basis, and today's evolving health care market. The DoN Program sees DPH's role as balancing the needs of individual systems of care and the Commonwealth's "health priorities" at the state and regional level.

The DoN Program is also trying to align its efforts with those of other state agencies with jurisdiction over the health care market, most notably the HPC. For example, DPH proposes to retool the process for transfer of ownership to a "streamlined, coordinated process" reflective of a "critical cross-agency collaboration" with the HPC's notice of material change/cost and market impact review process.  Applicants seeking DoN approval for transfer of ownership will be asked to demonstrate how the proposed transaction would add measurable public health value.

Currently, the applicant for DoN approval is the provider/facility directly affected by the project (e.g., the community hospital seeking approval for a substantial capital expenditure to build a new emergency department). The proposed regulations define the applicant as the registered provider organization (a HPC term) of which the applicant is a part.  In this way, the DoN Program proposes to support successful health care reform, including efforts to transition providers towards greater risk.  These proposed changes reflect DPH's desire to move its review process towards the ACO market, with incentives for value (controlled cost and improved quality) and greater risk sharing,

The DoN Program maintains that the proposed regulations will lift barriers to competition in several areas. Consistent with the findings of HPC's report, Community Hospitals at a Crossroads the DoN Program would lift its current policy not to accept DoN applications for new freestanding ambulatory surgery centers (ASCs), allowing for controlled expansion of ASCs by existing hospitals or joint ventures with existing hospitals.

Other areas of notable revision include a retooled review process concerning what has been known as new technology or innovative service. Under the proposed regulations, "DoN-Required Equipment or New Technology" will continue to include, at a minimum, magnetic resonance imagers and linear accelerators, with the goal of controlling spending on equipment and services that are evidenced to be significant cost drivers without a corresponding return on investment (or low value services).

The DoN Program also seeks to "insist" on real community engagement to increase transparency and objectivity, to hold DoN applicants truly accountable for adherence to public promises and DoN approval conditions, to align community investments with actual data-driven needs.

While the regulations are specific to Massachusetts, DPH's analysis of the history and evolution of DoN (often called certificate of need (CoN)) programs in several states is interesting reading. DPH notes that fourteen states have repealed or otherwise do not have CoN laws in effect.  Perhaps in response to those who would like to see Massachusetts eliminate or significantly cut back DoN review to allow market forces to shape the health care system through increased competition, the Presentation highlights data showing negative results from certain states that did away with their CoN programs, albeit from our DoN Program's perspective as to why this review process remains relevant and valuable.

Finally, DPH is making an effort to streamline the DoN review process and regulations. Consistent with Governor Baker's Executive Order 562, which directed all executive branch state agencies to review and, where possible, streamline, simplify and improve them, the proposed regulations cuts 40 pages of regulatory text (57% of current text) and DPH has made efforts to make the regulations more straightforward.

The written public comment period is open through October 7, 2016. Two public hearings are scheduled for September 21, 2106 in Boston, and for September 26, 2016 in Northampton.  In addition, in October 2016, DPH plans to convene public listening sessions to engage in community-level discussions on community health initiatives/health priorities. In October/November 2016, DPH also expects to hold public listening sessions and "expert panels" on the development of sub-regulatory guidance.

Because the DoN Program affects many different provider types with varying and often inconsistent interests public comment is expected to be robust and, indeed, began at the PHC meeting with several PHC members offering preliminary comments. PHC member Paul Lanzikos (appointed to the PHC by the Secretary of Elder Affairs) expressed concern that the proposed regulations pay scant attention to long term care services and asked that at least one session in the hearing process be devoted to long-term care.

Providers should carefully review the proposed regulations in light of potential immediate and long term effects on their organizations and the Massachusetts health care system as a whole. The coming months should produce interesting discussion and public debate as the DoN Program moves these proposed regulations forward.

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.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

In association with
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.