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New CMS Proposed Rule Revises Long-Term Care Facility Requirements for Medicare and Medicaid Program Participation

On July 13, 2015, the Centers for Medicare & Medicaid (CMS) issued a long-awaited proposed rule (Proposed Rule) that would revise the requirements that long-term care (LTC) facilities must meet to participate in the Medicare and Medicaid programs. Comments to the Proposed Rule are due sixty (60) days from tomorrow’s anticipated publication in the Federal Register

The Proposed Rule represents the first comprehensive change to the conditions of participation (CoPs) since 1991. As CMS notes, the population of nursing homes has changed substantially since 1991 — becoming more diverse and more clinically complex. CMS stated that the revisions were generally aimed at aligning requirements with current clinical practice standards to improve resident safety along with the quality and effectiveness of care and services delivered to residents.

This proposal is part of a broader CMS initiative to update the various provider CoPs, reflecting thematic changes in CMS’ quality regulation. However, this proposal also comes at a time when CMS is making significant changes to the broader post-acute reimbursement system, further taxing a provider community that faced significant reimbursement cuts a few years ago.

Given the significance of the Proposed Rule and the relative infrequency with which such broad changes are considered, the long term care industry should focus immediately on the practical implications.  As noted above, comments to the Proposed Rule will be accepted by CMS until September 14. 

The Proposed Rule includes the following major provisions:

  • Requirement of a facility-wide assessment to determine what resources are necessary to care for the facility’s residents competently during both day-to-day operations and emergencies.  The assessment includes, but is not limited to, the number of residents, resident acuity, range of diagnoses and the content of care plans.
  • A “competency” requirement for determining sufficient nursing and other staff based on the facility assessment. The staff must have the appropriate competencies and skills to address the needs of the resident population.
  • Requirements for comprehensive person-centered care planning as part of the pre-admission screening and resident review (PASARR) and preparation of a baseline care plan within 48 hours of admission, along with related requirements for an interdisciplinary team and discharge planning.
  • Addition of extensive and specific compliance program requirements (in conformance with requirements in the Affordable Care Act), including training, the compliance officer and facility-based compliance liaisons.
  • New requirements related to behavioral health services, including mental and psychosocial illnesses and non-pharmacological interventions.
  • Substantial additional changes related to pharmacy services, including the requirement that a pharmacist review a resident’s medical chart at least every six months and when the resident is new to the facility, a prior resident returns or is transferred from a hospital or other facility, and during each monthly drug regimen review when the resident has been prescribed or is taking a psychotropic drug, an antibiotic or any drug the Quality Committee has requested be included in the pharmacist’s monthly drug review. Attending physicians would be required to review any irregularity identified by the pharmacist.
  • Focus on the appropriate use of psychotropic medications, including limits on “as needed” orders, and (unless clinically contraindicated) gradual dose reductions, and behavioral interventions, in an effort to limit use of psychotropic drugs.
  • “Clarifications” on the ordering and receipt of laboratory, radiology, and other diagnostic services.
  • Extensive enhanced requirements for food and nutrition, including employment of a staff with the appropriate competencies and skills sets to carry out the functions of the dietary service while taking into consideration resident assessments, and individual plans of care, including diagnoses and acuity, and factors such as religious requirements and personal preferences.
  • “Clarifications” regarding what constitutes rehabilitative services for mental illness and intellectual disability and an addition of respiratory services to those services identified as specialized rehabilitative services and establishment of new health and safety standards for facilities that choose to provide outpatient rehabilitative therapy services.
  • Enhanced requirements around transitions of care from one facility to another.
  • Specific limits on binding arbitration agreements presented to residents and a prohibition against conditioning admission upon the resident or the resident representative signing a binding arbitration agreement.
  • A requirement that LTC facilities develop, implement, and maintain an effective comprehensive, data-driven Quality Assurance and Performance Improvement (QAPI) program that focuses on systems of care, outcomes of care and quality of life.
  • Requirements around the implementation of an infection prevention and control program, including formal designation of an infection control and prevention officer for each facility.
  • New limits on the number of residents who may share a bedroom (i.e., no more than two (2)), and requirements around availability of private, in-room toilet facilities.
  • Extensive and specific requirements around training of new and existing staff, individuals providing services under a contractual arrangement, and volunteers.
  • Requirements to comply with federal, state and local laws regarding smoking.
  • Enhanced requirements around employment and contractor relationships designed to protect residents from abuse, neglect, mistreatment or misappropriation of property.

Implementation

CMS generally implements changes to regulatory requirements for survey and certification processes within twelve (12) months of the final rule. CMS has anticipated that it may take a longer period of time to implement these changes to COP. Nonetheless, an important area for potential comment is the period of time in which the long term care industry will have to implement the changes, once they are finalized.

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Jason B. Caron, health care attorney with McDermott Will & Emery law firm
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Jason B. Caron is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Washington, D.C., office. 

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Sandra DiVarco, Hospitals Attorney, Health Systems Lawyer, McDermott Will Emery, Chicago Law Firm
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Sandra DiVarco is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Chicago office. Sandy focuses her practice on the representation of hospitals and health systems. She has counseled health care facility and system clients regarding all aspects of health law transactions and health system restructurings. As a registered nurse, Sandy regularly advises clients on the legal aspects of clinical issues and policy/procedure matters. Sandy also has significant experience in assisting clients with regulatory, licensure and accreditation issues, including state-level and CMS survey responses, formulation of successful Plans of Correction, Joint Commission complaint responses and EMTALA/regulatory investigations. Sandy is a member of the Firm’s Catholic Organizations Practice Group, and has experience working with Catholic organizations within health care and other business areas. She is also co-leader of the Firm’s General Institutional Provider affinity group. 

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Karen Owen Gibbs, Health, Life sciences, Attorney, McDermott Will, Law Firm
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Karen Owen Gibbs is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Chicago office.  She has extensive background in regulatory, compliance and policy issues in the health care and life sciences industries, including pharmacies (retail, mail and specialty), pharmaceutical and biologics manufacturers, pharmacy benefit management (PBM) companies, device manufacturers, durable medical equipment (DME) suppliers, hospitals, retail clinics and senior living facilities.   Karen also has substantial experience advising investors and lenders focused on those...

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Tony Maida Health Care Attorney McDermott WIll Law Firm
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Tony Maida is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s New York office.  Tony has extensive experience in health care fraud and abuse and compliance issues, including the federal Anti-Kickback and Physician Self-Referral/Stark laws, false claims and overpayments, and government investigations.    He works closely with our health and white collar teams on criminal, civil, and administrative investigations and counseling clients on corporate transactions and compliance programs.

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Joel C. Rush is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Washington, D.C., office. He focuses his practice on transactional and corporate matters affecting health care organizations, including mergers and acquisitions, affiliations, joint ventures and venture capital investments.  Joel has extensive experience working on hospital and health system mergers and acquisitions. Previously, Joel was an associate in the healthcare and corporate services groups in the Washington, D.C. office of a national law firm. Joel graduated...

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