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.

Focus on the Opioid Crisis

The proposed amendments reflect DPH’s attention to the opioid crisis—an ongoing priority. The proposed amendments would eliminate duplicative licensure review for hospitals offering substance abuse services if they have already been approved by the Bureau of Substance Abuse Services (BSAS), which aligns nicely with DPH’s goal of facilitating the opening of new and expanded services in this important area.

Changes for Maternal/Newborn Services and Cardiac Service Lines

DPH proposes to update and consolidate certain sections of the regulations, including those relating to Maternal and Newborn Services, Cardiac Surgery and Cardiac Catheterization.

For Maternal and Newborn Services, DPH’s proposed amendments aim to give hospitals more room for innovation in patient care approaches, including development of policies for patient and family services that best reflect the needs of each hospital’s community. Hospitals would have to meet fewer prescriptive data collection and reporting requirements, but DPH would still retain the ability to request more data through guidelines. Levels of maternal and newborn services would build sequentially and logically from one level to the next. Physical plant requirements would align with nationally recognized Facility Guidelines Institute (FGI) requirements. Hospitals will no longer have to have to adhere to the maternity beds +1 count for bassinets in the newborn nursery. DPH also recommends rescinding current regulatory requirements for freestanding birth centers included at 105 CMR 142.000, and incorporates applicable protocols for such centers in the amended regulations, which should clear up confusion on the part of hospitals that operate freestanding birth centers.

The licensure and maintenance of hospital cardiac catheterization services has been the cause of some regulatory uncertainty and operational angst. DPH proposes to remove its current moratorium on new cardiac catheterization services within a 20-minute ambulance ride of another program and to replace current circular letters with comprehensive guidance. The proposed amendments create a licensing process that includes review of the proposed cardiac catheterization program for compliance with regulatory standards and quality and access requirements.

Hospitals would be able to apply to operate diagnostic, diagnostic and interventional, and pediatric cardiac catheterization programs, as well as electrophysiology, regardless of whether they can provide cardiac surgery on site. These measures are designed to increase operational certainty and DPH expects they may result in increased geographic access to these services. DPH would replace its current requirement that hospitals perform a stated minimum annual number of diagnostic and/or interventional catheterizations annually with volume minimums based on evidence-based guidelines and standards issued by the American College of Cardiology, the American Heart Association and the Society for Cardiac Angiography and Interventions, which should help DPH requirements to keep pace with nationally recognized standards. Hospitals that do not meet minimums would still need to submit quarterly QAPI reports to DPH. DPH sees no anticipated need for mobile cardiac catheterization programs, which currently do not exist in the Commonwealth, and proposes to remove references to such programs.

In another shift to keep pace with ever-changing standards, DPH would eliminate physician/operator volume minimum requirements for percutaneous coronary interventions, requiring hospitals to establish privileging criteria to ensure that staff is trained and competent to perform the service. Annual MassDAC reports will identify physicians with outlier mortality outcomes, enabling DPH to address potential problems, which DPH notes as a rationale for this change.

Closure of Essential Services

DPH proposes significant changes to the notice requirements for closure of an essential service, which currently requires the filing of a 90-day notice with DPH, public notice, and a public hearing at which the hospital must explain its closure plan. Essential services include a hospital campus or service (including outpatient psychiatric and mental health services and reproductive health services) that is not specifically excepted from the definition of an essential service. Under the proposed amendments, the hospital would also need to provide 90-day notice of such closures to the Health Policy Commission, the Center for Health Information and Analysis, the Massachusetts Attorney General, and the Executive Office of Labor and Workforce Development. Health care coalitions and community groups identified by the hospital in its notice will continue to receive notice. These provisions are consistent with proposed changes to other regulations, such as the Determination of Need regulations discussed in a previous post, that seek to coordinate communication and processes across governmental agencies and other stakeholders.

However, DPH also proposes that the hospital must also provide notice to a number of other stakeholders 30 days before filing the 90-day notice with DPH. These groups include the hospital’s patient and family council, each hospital staff member, every labor organization that represents the hospital’s workforce, the state legislative delegation for the hospital’s district, and a representative of the municipality where the hospital is located. This effectively increases the minimum time frame for closure of an essential service to 120 days.

Other Updates

Finally, DPH proposes some changes necessary to conform the hospital regulations with current statutes. These include, for example, updating the nurse-to-patient ratio to comply with M.G.L. c. 111, s. 231, eliminating bed count reporting requirements, which were removed from M.G.L. c. 111 s. 51 (the Hospital Licensure Statute) by Chapter 402 of the Acts of 2014. Other changes are more corrective in nature. For example, the proposed amendments eliminate the provisional licensure category, which is not actually part of the Hospital Licensure Statute and update the evidence of responsibility and suitability for licensure requirements to more closely track the statutory requirements.

Comment Period is Open

The written public comment period is open through 5:00 p.m. on October 28, 2016. A public hearing is scheduled for October 24, at 9:30 a.m., Room 417, 239 Causeway Street, Boston, MA 02114.

Hospitals are, no doubt, undertaking a careful review of the proposed amendments. If the DoN public hearing held on September 21 is any indication, DPH should expect strong engagement from hospitals, as well as other stakeholders in this process.