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January 16, 2017

DPH Adopts New Determination of Need Regulations

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The Department of Public Health (“DPH”), on behalf of the Baker-Polito Administration, recently adopted landmark regulations with the goal of reforming the Determination of Need (“DoN”) Program. The new regulations go into effect on January 27, 2017 and significantly change the DoN Program by incorporating “public health and community principles” into its review. In addition to striving to control healthcare costs while ensuring access to care and the availability of needed health care resources, the new regulations focus on addressing health equity and social determinants of health.

Key Points

  • On January 11, 2017, the Department of Public Health (“DPH”) Public Health Council adopted new DoN regulations which go into effect on January 27, 2017.
  • Focuses DoN on promoting planned growth, containing cost, increasing access, and addressing traditional public health goals and social determinants of health.
  • Shifts the focus of DoN from an individual provider to healthcare systems. DoN applications will be filed by the parent organization, rather than the individual clinic or hospital.
  • Lifts moratorium on ambulatory surgery for hospitals and freestanding ambulatory surgery centers within certain limitations.
  • Imposes new Factors of Review for all DoN Projects, including changes of ownership.
  • Retools process for reviewing changes in ownership by giving DPH authority to allow a transaction to go forward notwithstanding unfavorable comments from the Health Policy Commission.
  • Reinforces DoN Regulation of technology and services, including MRI, PET, proton beam, linear accelerators.
  • Creates process for abbreviated review of select physical plant (“conservation”) projects aimed at sustaining or restoring the physical plant that do not involve expansion of services.
  • Reaffirms DPH’s commitment to “Community Based Health Initiatives” (“CHI”).
  • Reinforces the prohibition on disaggregation.
  • Changes the public notice timelines and adds new parties that are required to get direct notice of DoN filings.
  • Requires Medicaid participation for DoN approval.
  • Provides DPH with new enforcement powers and penalties for non-compliance.
  • Allows Part 1 architectural plan review to occur when the DoN is pending.
  • Does not regulate urgent care or limited service clinics.

Resources

  1. DPH Final PHC Memo - Determination of Need 105 CMR 100.000 FINAL 1-11-17
  2. DPH Final Redline Reg - Determination of Need 105 CMR 100.000 FINAL 1-11-17
  3. Final Proposed Revision of Determination of Need, 105 CMR 100.000
  4. Updated Determination of Need 2-Pager
  5. 105 CMR 100.000 Subreg Slides 1-11-17

About the Authors

Andrew Levine

Andrew Levine is the senior partner overseeing the firm’s Health Law Regulatory practice. He provides regulatory guidance, business and corporate legal services, as well as strategic advice to healthcare clients. You can find him on Google+ and LinkedIn.

Crystal Bloom

Crystal Bloom is a partner and Chair of the firm's healthcare regulatory practice. She provides state and federal regulatory guidance and corporate legal services to healthcare providers. You can find her on LinkedIn.

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