Contact
Boston
Providence
March 18, 2014
Department of Public Health proposes changes to Determination of Need regulations
The Massachusetts Department of Public Health (DPH) recently issued proposed amendments to the Determination of Need (DoN) regulation, 105 C.M.R. 100.000. The regulations are designed to implement the DoN changes that were mandated in Chapter 224 of the Acts of 2012 (“Chapter 224”). Some of the most significant changes include the following:
Hospitals may no longer expand ambulatory surgery capacity without DoN approval
Prior to passage of Chapter 224, the DPH regulations governing the DoN formula for Ambulatory Surgery Centers (ASC) provided that no freestanding ASC could be established or expanded without DoN approval, while at the same time, hospitals could expand ambulatory surgery capacity without DoN approval if the project cost was under $25 million. Consistent with the passage of Chapter 224, DPH proposes to amend the definition of “ambulatory surgery” to make it clear that wherever DoN applies to ambulatory surgery, it does so whether the facility is a clinic or a hospital. The effect of this change has been in place since Chapter 224 was enacted. Thus, this change reaffirms that the loophole allowing hospitals to expand outpatient operating room capacity without DoN approval is no longer available.
Independent Cost Analysis may be requested by DPH
DPH may require applicants to provide an independent cost analysis, at their own expense, to demonstrate that applications for a substantial change in service or substantial capital expenditure are consistent with the healthcare cost-containment goals of the Commonwealth and the Health Policy Commission (HPC). At this time, it does not appear that this proposed rule applies to applications for transfers of ownership.
The Amendments clarify the Health Policy Commission’s participation
While the proposed amendments clarify the right of the HPC to review and comment on DoN applications, it also indicates that the HPC has the right to recommend that DPH require an independent cost analysis.
The Attorney General’s right to intervene in the DoN process is reaffirmed
Chapter 224 provided the Attorney General (AG) with a formal role in the review of DoN applications. DPH is proposing to formally recognize this role by adopting regulations that recognize the participation of the AG in the review of DoN applications. Under the current DoN regulations, the AG is not a “party of record” and thus does not participate in DoN application review or proceedings. The proposed amendment clarifies the right of the AG to request a public hearing, comment on DoNs, and intervene in a hearing.
Applications may be guided by State Health Plan
DPH proposes to formally tie the DoN process with the anticipated implementation of the State Health Plan developed by the DPH through the Health Planning Council. The State Health Plan will identify the needs of the Commonwealth in healthcare services, providers, programs, and facilities. All applications submitted after the date of filing of the first State Health Plan may be guided by the State Health Plan’s identified needs, the resources available to meet those needs, and the priorities for addressing those needs.
Applications may be approved more quickly
With the passage of Chapter 224, DPH will have a four-month window, rather than the eight-month window specified by the current regulations, to approve or disapprove each DoN application. If a cost analysis study is required, then the four month review clock is stayed. In addition, the proposed regulations reaffirm a judicial remedy if DPH has not taken action on the application within the four month time limit.
Application filing fees may double
Consistent with the passage of Chapter 224 of the Acts of 2012, DPH proposes to increase the DoN application filing fee from 0.1% to 0.2% of the total capital expenditure. Until such time as DPH establishes a new fee by regulation, the current fee will remain in effect.
DPH will hold a public hearing on the proposed amendments sometime in April, 2014. The exact date is yet to be determined. In its proposal, DPH indicated it contemplated promulgating the final regulations by June or July. To view the proposed DoN amendments in their entirety please click here..
About the Author
Sign up for email alerts
© 2021 | website: visual dialogue
News
Health Law
-
August 27, 2020
Best Lawyers in America® 2021 Recognizes Summit Health Law Partners Attorneys
-
June 03, 2020
Adelita Orefice, Esq. Honored by Rhode Island Monthly
-
April 17, 2020
Healthcare fraud warning from the Massachusetts U.S. Attorney arising out of COVID-19
-
April 10, 2020
Financial Solutions for Small Businesses Disrupted by COVID-19
-
March 26, 2020
Massachusetts and the Federal Government Expand Telemedicine Services and Coverage in Response to COVID-19
-
March 23, 2020
COVID-19 Update for Our Clients
-
August 27, 2019
Best Lawyers in America® 2020 Recognizes Summit Health Law Partners Attorneys
-
November 06, 2018
Sweeping New Opioid Law Extends Anti-Kickback Liability to Private Insurance Market in Three Areas
-
November 05, 2018
Adelita Orefice Earns Certification in Healthcare Compliance
-
October 22, 2018
Super Lawyers® Recognizes Summit Health Law Partners Attorneys
-
September 18, 2018
| Crystal Bloom, Andrew Levine
DPH releases proposed amendments to Determination of Need regulation
-
August 20, 2018
| Robert Blaisdell
Governor Baker Signs Sweeping Reform on Employee non-Competition Agreements Law
-
August 15, 2018
Best Lawyers in America® recognizes Summit Health Law Partners attorneys for their excellence in law.
-
October 24, 2017
| Jeffrey Chase-Lubitz
Legal Issues and the Aging Physician
-
October 11, 2017
| Andrew Levine
Department of Public Health Presentation on DoN Regulations
-
August 22, 2017
Best Lawyers, Lawyers Weekly, and Superlawyers Recognize DBS Attorneys
-
July 20, 2017
Massachusetts Supreme Judicial Court rules that terminating an employee for using medical marijuana may constitute handicap discrimination.
-
February 16, 2017
| Diane Moes
The ACA May Be in Jeopardy, but MACRA Isn’t Likely to Go Away
-
January 16, 2017
| Andrew Levine, Crystal Bloom
DPH Adopts New Determination of Need Regulations
-
November 09, 2016
| Andrew Levine, Crystal Bloom, Adelita Orefice
UPDATE: Preliminary Injunction Temporarily Halts Implementation of Final Rule Prohibiting Pre-Dispute Arbitration Contracts in LTC Facilities
-
October 24, 2016
| Andrew Levine, Crystal Bloom, Adelita Orefice
UPDATE: Nursing Facilities Sue HHS to Block Ban on Pre-Dispute Binding Arbitration Agreements
-
October 17, 2016
| Andrew Levine, Crystal Bloom, Adelita Orefice
HHS Prohibits Long-Term Care Facilities from Using Pre-Dispute Binding Arbitration Agreements
-
August 31, 2016
| Robert Blaisdell,
Massachusetts Enacts Equal Pay Act: What employers can do now to prepare for its implementation
-
August 29, 2016
| Andrew Levine, Crystal Bloom
Massachusetts Department of Public Health Announces Major Determination of Need Regulatory Reform Initiative
-
August 29, 2016
New MA Prescription Monitoring Program Goes Live August 22, 2016
-
August 15, 2016
| Crystal Bloom, Amanda Beauregard
OPPS 2017 – Implementation of Section 603 of the Bipartisan Budget Act of 2015
-
August 12, 2016
| Robert Blaisdell
CMS cracks down on “abuse” of nursing home residents via social media
-
July 20, 2016
| Kelly McGee, Adelita Orefice
Rhode Island Prohibits Physician Non-Competes
-
June 28, 2016
Massachusetts Trial Court Dismisses Wrongful Employment Termination Claim Based on Medical Marijuana Use
-
May 17, 2016
| Robert Blaisdell,
Noncompliance with Security Deposit Law Could Be a Defense to Eviction
-
April 19, 2016
| Crystal Bloom
Update Regarding DPH Increased Oversight of Long-Term Care Facilities
-
April 11, 2016
| Crystal Bloom
DPH Strengthens Oversight of Long-Term Care Facilities
-
March 23, 2016
| Andrew Levine, Andrew Ferrer
Governor Baker Signs Legislation Designed To Address Opioid Crisis
-
March 23, 2016
| Kelly McGee
Phase 2 HIPAA Compliance Audits Set To Begin
-
March 22, 2016
| Robert Blaisdell,
Failure to execute HIPAA business associate agreement and conduct risk analysis costs health system $1.55M
-
February 11, 2016
| Kelly McGee
Proposed Rule Modifies 42 CFR Part 2, the Confidentiality of Alcohol and Drug Abuse Patient Records Regulations
-
November 16, 2015
| Andrew Levine, Crystal Bloom, Nicole Sexton
Medicare Hospital Reimbursement Changes
-
October 26, 2015
Diane Moes named one of Mass Lawyers Weekly’s “Top Women of Law”
-
June 12, 2015
OIG Fraud Alert Warns Doctors That They Will Be Personally Accountable for Violations of Federal Anti-Kickback Statute
-
May 15, 2015
| Andrew Levine
Long Term Care Facility Regulatory Update
-
April 23, 2015
| Andrew Levine
Department of Public Health - new process for the addition of licensed mobile or portable health care units
-
April 21, 2015
| Paul Barrett, Jeffrey Chase-Lubitz
OIG Releases Compliance And Oversight Guide for Healthcare Boards
-
April 20, 2015
| Andrew Levine,
Massachusetts Department of Public Health Revamps Application Process for Registered Medical Marijuana Dispensaries
-
April 16, 2015
| Crystal Bloom, Andrew Levine
Proposed Legislation Will Increase Legal Authority of Health Policy Commission and Attorney General
-
March 15, 2015
| Andrew Levine
Health Policy Commission Releases Proposed Regulation Concerning Nurse-to-Patient Ratios | Public hearings scheduled for late March and early April
-
March 06, 2015
| Robert Blaisdell
Court Holds Officers and Directors of Non-Profit Healthcare Facility Personally Liable to Creditors for Breach of Fiduciary Duty
-
September 17, 2014
| Andrew Levine, Robert Blaisdell, Kathleen Harrell
Legal Issues Associated with MA Registered Marijuana Dispensaries: An article by Andrew Levine, Robert Blaisdell, and Kathleen Harrell
-
July 14, 2014
| Andrew Levine
Important Compounding Pharmacy Law Empowers Board of Registration in Pharmacy
-
June 20, 2014
| Crystal Bloom, Andrew Levine
Public Health Council Approves Amendments to Determination of Need Regulations
-
June 03, 2014
| Diane Moes
U.S. District Court Ruling Vacating HRSA’s 340B Program Orphan Drug Exclusion Rule Casts Uncertainty on Forthcoming "Mega-Rule"
-
May 28, 2014
| Andrew Levine
New Guidelines for Dementia Special Care Unit Regulations
-
January 10, 2014
| Andrew Levine
MassHealth Changes regulations to comply with Affordable Care Act
Litigation
-
August 27, 2020
Best Lawyers in America® 2021 Recognizes Summit Health Law Partners Attorneys
-
May 12, 2020
First Federal Indictment Arising Out of Fraudulent Applications for Paycheck Protection Program Loans Highlights Focus on COVID-19 Related Investigations
-
April 30, 2020
Impact of COVID-19 on Reporting Foreign Components
-
March 27, 2020
| Michelle Peirce
Scam Warning for Massachusetts Physicians
-
August 27, 2019
Best Lawyers in America® 2020 Recognizes Summit Health Law Partners Attorneys
-
October 22, 2018
Super Lawyers® Recognizes Summit Health Law Partners Attorneys
-
August 15, 2018
Best Lawyers in America® recognizes Summit Health Law Partners attorneys for their excellence in law.
-
April 05, 2018
In Russia probe, the difference between ‘target’ and ‘subject’ matters a great deal
-
February 22, 2018
Landmark Supreme Court Decision Substantially Narrows the Applicability of the Dodd-Frank Whistleblower Provision
-
August 22, 2017
Best Lawyers, Lawyers Weekly, and Superlawyers Recognize DBS Attorneys
-
July 20, 2017
Massachusetts Supreme Judicial Court rules that terminating an employee for using medical marijuana may constitute handicap discrimination.
-
August 31, 2016
| Robert Blaisdell,
Massachusetts Enacts Equal Pay Act: What employers can do now to prepare for its implementation
-
August 12, 2016
| Robert Blaisdell
CMS cracks down on “abuse” of nursing home residents via social media
-
June 28, 2016
3 Things Every Massachusetts Podiatrist Should Know About the Proposed Amendments to Podiatry Regulations
-
June 01, 2016
How Recent Changes to the Fair Labor Standards Act’s “White Collar” Exemptions May Affect Your Small Business
-
March 25, 2015
Avoiding Securities Fraud Prosecution: Using the SEC’s 2015 examination priorities as a compliance roadmap when dealing with retail investors.
-
December 29, 2014
| Bruce Singal
Was the Ferguson grand jury rigged?
-
March 26, 2014
Employer Avoids Discrimination Trial Thanks to Robust Investigation and Documentation Policies
-
February 13, 2014
| Michelle Peirce
Shielding Companies Against Whistleblower Suits
-
March 01, 2010
Trials Facing Women Litigators and Tips For Success: Michelle Peirce
-
“Official Immunity” for Private Research Institutions: How a recent federal court decision impacts civil tort lawsuits arising out of research misconduct inquiries / investigations.
-
Research Misconduct Penalties and How to Avoid Them
Corporate
-
August 20, 2018
| Robert Blaisdell
Governor Baker Signs Sweeping Reform on Employee non-Competition Agreements Law
-
March 16, 2018
Massachusetts Equal Pay Act: 5 Things Every Employer Should Do Before It Takes Effect On July 1, 2018
-
August 22, 2017
Best Lawyers, Lawyers Weekly, and Superlawyers Recognize DBS Attorneys
-
June 28, 2016
Massachusetts Trial Court Dismisses Wrongful Employment Termination Claim Based on Medical Marijuana Use
-
June 28, 2016
3 Things Every Massachusetts Podiatrist Should Know About the Proposed Amendments to Podiatry Regulations
Research Misconduct
-
May 18, 2020
Why Grantees Must be Prepared for Heightened Scrutiny of Conflicts of Interest in Foreign Support for US Research
-
March 23, 2016
| Andrew Levine, Andrew Ferrer
Governor Baker Signs Legislation Designed To Address Opioid Crisis
-
What is Research Misconduct and Why Should I Care?
-
“Official Immunity” for Private Research Institutions: How a recent federal court decision impacts civil tort lawsuits arising out of research misconduct inquiries / investigations.
-
Research Misconduct Penalties and How to Avoid Them
This website presents general information about Barrett & Singal and is not intended as legal advice nor should you consider it as such. You should not act upon this information without seeking professional counsel.
Please note that contacting Barrett & Singal by email, telephone or facsimile will not establish an attorney-client relationship, obligate us to act as your attorney or impose an obligation on either the law firm or the receiving lawyer to keep the transmitted information confidential. Completion of Barrett & Singal’s new client intake protocol, including without limitation the firm’s conflicts checking process and an engagement letter, is necessary to establish an attorney-client relationship. Absent a current attorney-client relationship with Barrett & Singal, any information or documents communicated or transmitted by you to Barrett & Singal will not be treated as confidential, secret or protected in any way. If you are not a current client of Barrett & Singal, please do not send any confidential information to us through this web site or otherwise concerning any potential or actual legal matter you have. Before providing any confidential information to us, you must obtain permission to do so from one of the firm’s lawyers. By clicking "Accept," you acknowledge that we have no obligation to maintain the confidentiality of any information you submit to us unless we already represent you or unless we have agreed to receive limited confidential material/information from you as a prospective client.
If you would like to discuss becoming a client, please contact one of our attorneys to arrange for a meeting or telephone conference. If you wish to disclose confidential information to a lawyer in the firm before an attorney-client relationship is established, the protections that the law firm will provide to such information from a prospective client should be discussed with the firm attorney before such information is submitted. Thank you for your interest in Barrett & Singal.