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March 29, 2017

Final Implementations to Hospital Licensure Regulation: 105 CMR 130.000

By

The Department of Public Health (“DPH”), on behalf of the Baker-Polito Administration, recently adopted revised hospital licensure regulations. The new regulations set forth standards for maintaining and operating hospitals while promoting the goals of quality care delivery, industry standardization, and patient consumer protection. The new regulations are anticipated to go into effect on April 7, 2017. The following is a summary of some of the key changes.

Changes to Essential Service Closure Process

  • Lengthens the timeline for closure of an essential health service to 120 days.
  • Hospitals must notify DPH and the following parties of a proposed closure at least 30 days prior to notifying DPH: the hospital’s patient and family council, staff members, labor organizations, state representatives of the city or town where the hospital is located, and a representative of the local offices of the city or town where the hospital is located
  • Maintains the requirement for hospitals to notify DPH at least 90 days prior to the proposed closure.
  • Requires a copy of the essential service closure notice to be sent to the Health Policy Commission, the Attorney General, the Center for Health Information and Analysis, the * Executive Office of Labor and Workforce Development, and any health care coalition and community groups identified by the hospital in its notice to DPH.
  • Cardiac catheterization continues to be part of the list of services excluded from the essential service notice process and has been revised to reflect that it includes diagnostic, pediatric, and diagnostic and interventional cardiac catheterization services.
  • Adds electrophysiology to the list of services excluded from the essential service notice process.
  • Adds satellite emergency facilities to the list of services required to comply with the essential service notice requirements.
  • Imposes a new requirement to include a detailed account of community engagement and planning that occurred prior to filing the essential services closure notice.

Licensure of Substance Use Disorder Services

  • Requires substance use disorder treatment programs to obtain licensure only from the Bureau of Substance Abuse Services and eliminates the need for licensure approval of substance use disorder services from the Division of Health Care Safety and Quality.

Implementation of New Licensure Process for Cardiac Catheterization Services

  • Adds new definition for cardiac catheterization service to include diagnostic and interventional services.
  • Creates a new licensure process for cardiac catheterization services, allowing any hospital to apply for licensure of an adult cardiac catheterization service, pediatric cardiac catheterization service, or electrophysiology service.
  • Replaces the specific minimum required caseload volumes with service volume minimums defined by DPH guidelines that are based on guidelines and standards issued by the American College of Cardiology, the American Heart Association, and the Society for Cardiac Angiography and Interventions.
  • Eliminates the moratorium restricting cardiac catheterization service licensure for a hospital located within 30 minutes of an existing PCI-capable hospital.
  • Prohibits hospitals without on-site cardiac surgery from performing certain specific procedures.

Transfer of Ownership and Change in Location or Name

  • Creates a definition for Transfer of Ownership, which was not previously defined in the hospital licensure regulations.
  • Formally incorporates prior DPH policies regarding hospital transfers of ownership in the hospital licensure regulations, including suitability policies.

Serious Reportable Events and Serious Adverse Drug Events

  • Adds definition for Serious Adverse Drug Event (SADE) and requires a hospital to report serious reportable events (SRE) involving medication errors that meet the definition of a SADE.
  • Requires hospitals to follow both SADE and SRE reporting requirements in situations that trigger both requirements.
  • Limits the scope of SRE to a class of events that are largely preventable and harmful.
  • Permits a fine of up to $1,000 per day per violation, license revocation or suspension, or both in the event of noncompliance with the new SADE reporting requirements.
  • Allows disclosure of SREs to patient or patient’s representative to be conveyed orally, in writing, or both.

Other Key Points

  • Streamlines Maternal and Newborn Services licensure application process
  • Conditions acute-care hospital licensure on the submission of a community benefits plan and allows a community benefits plan filed with the Attorney General’s office or DPH under Determination of Need requirements to satisfy of this requirement.
  • Eliminates provisional licensure provisions for hospitals not in full compliance with applicable licensure requirements.
  • Requires hospitals to have written policies and procedures for implementation of discharge planning services.
  • Creates new section regarding Birth Center Services requirements.

About the Authors

Nicole Sexton

Nicole Sexton is an attorney in the firm’s Health Law practice, where she provides legal counsel to a wide range of healthcare providers. You can find her on LinkedIn.

Andrew Levine

Andrew Levine is a partner and head of the firm's 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.

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