The third set of proposed regulations focuses on requirements for facility licensure, ownership transparency, and safety, including infection prevention and control. The latest proposals further eliminate provisions that duplicate federal requirements and update application requirements for new facilities and for change in ownership of existing facilities.
Governor Wolf’s administration continued its release of regulations in furtherance of the Commonwealth’s first overhaul to long-term care nursing facility regulations since 1999. On March 19, 2022, the Pennsylvania Department of Health (the Department) published the third set of proposed regulations in the Pennsylvania Bulletin. The Department now intends to finalize only one additional set of proposed regulations by combining the contents of the originally contemplated fourth and fifth sets. Future revisions are still expected to include proposed revisions to regulations for health care services offered by regulated facilities and residents’ rights. On December 15, 2021, the Department held a meeting to discuss proposed regulation sets one and two. The Department will hold another meeting upon conclusion of the comment periods for the third and fourth sets, collectively. The Department then will submit all four sets in a comprehensive final-form regulatory package.
The third set of proposed regulatory revisions focuses on standards related to facility licensure and ownership, as well as prevention and preparedness for disease and disaster.
More specifically, the Department proposes to:
- Clarify that (i) the same application process applies to new facilities and changes in ownership for existing facilities and (ii) regulatory requirements apply to ownership and operation of a facility, rather than maintenance and operation of a facility;
- Remove references to the Bureau of Quality Assurance in anticipation of a future name change for the bureau;
- Add a requirement that facility owners (either for-profit or nonprofit) provide email addresses and phone numbers to the Department;
- Refine the definition of “ownership and control interest;”
- Require (in conjunction with applications for licensure or change in ownership) persons seeking to operate or assume ownership of a facility to submit: corporate history; a list of all affiliated licensed facilities in the United States; detailed summary of current or settled civil or criminal actions; information regarding bankruptcies and other “financial failures;” and licensing and regulatory history;
- Permit the Department to request any additional information to support an application under a “catch-all provision” in order to permit the Department to evaluate the intentions of proposed owners and operators with respect to quality of care;
- Require submission of a detailed staffing and hiring plan, including information related to management and the relevant entity’s governing body; and
- Add the name and address of the relevant owner to each facility license.
In determining whether to approve a new license or change in ownership, the Department will focus on: past performance related to owning or operating any other facility (in this Commonwealth or elsewhere); financial and organizational capacity operational capacity; past regulatory compliance; and past performance in delivering quality care. Poor performance related to these considerations will constitute “indications that an applicant may not be able to operate a long-term care nursing facility.”
Notably, the Department proposes to evaluate, on a case-by-case basis, whether to conduct an inspection related to a change in ownership (rather than conduct an inspection in every instance). The Department proposes certain clarifications to expedite collection of infectious disease and immunization records. Also proposed are requirements for facilities to conduct assessments, at least quarterly, sufficient to meet applicable federal requirements. Lastly, the Department proposes, generally, certain changes to align fire, disaster, and other emergency preparedness requirements with federal equivalents (though the Department also proposes to add a new reporting requirement about bed bugs based on recent increases in their prevalence).
The Department expects nominal increases in costs to various stakeholders due to the third set of proposed regulations. The Department continues to believe that consistency between Commonwealth and federal law will streamline Department survey processes and provide clarity to facilities. The Department itself expects to incur an increase of approximately $600,000 in salaries and benefits for personnel necessary to operationalize the above changes. The Department expects little to no financial impact on the 689 licensed long-term care nursing facilities in the Commonwealth or the general public, though prospective facility owners will be subject to increased scrutiny and administrative burden.
The previous sets of proposed changes focused on quality of care and administrative efficiency. This third set, by contrast, stems from the shift in ownership from nonprofit to for-profit entities as observed by the Department during this century. According to the Department, this shift has resulted in ownership structures of increasing complexity and limited liability, as well as limited transparency about who owns a given facility (or its real property) or maintains ultimate responsibility for resident care. Per the Department, leveraged buyouts conducted by private equity firms have resulted in sales of real estate assets, reduced staffing and, in some cases, facility closures. As such, the Department intends to increase vetting of prospective owners.
Comments to the proposed regulations may be submitted within 30 days of publication. The Department prefers to receive comments by electronic mail to RA-DHLTCRegs@pa.gov. Ballard Spahr’s Pennsylvania health care attorneys will continue to provide updates on the rollout of these sets of proposed rules as they become available.
Note: Persons without email access may contact Lori Gutierrez, Director, Office of Policy, 625 Forster Street, Room 814, Health and Welfare Building, Harrisburg, PA 17120, (717) 317-5426. Persons with a disability requiring alternative formatting may use V/TT (717) 783-6514 or contact the Pennsylvania Hamilton Relay Service at (800) 654-5984 (TT). Submissions should identify “proposed rulemaking 10-223 (Long-term care nursing facilities, Proposed Rulemaking 3).”