The State Operations Manual (SOM) in the Internet-Only Manual System is the primary repository of survey-and-certification rules and guidance from the Centers for Medicare and Medicaid Services. The entire manual can be accessed online here
Program Background & Responsibilities, Chapter 1, State Operations Manual (SOM)
Chapter 1, “Program Background and Responsibilities,” explains the basic role of certification and recertification in ensuring that healthcare providers meet the Medicare/Medicaid conditions of participation. It outlines CMS’ role in the process, as well as the responsibilities of the state survey agencies.
Certification Process, Chapter 2, State Operations Manual (SOM)
Chapter 2, “The Certification Process,” reviews the requirements for initial certifications, the rules for approval or denial, and procedures for reconsideration; issues involving change of ownership and voluntary terminations from Medicare; readmission criteria after involuntary terminations from Medicare or Medicaid; and timing requirements for resurveys.
Additional Program Activities, Chapter 3, State Operations Manual (SOM)
Chapter 3, “Additional Program Activities,” explains the rules involving adverse actions, including initial denials of Medicare provider requests for program participation and the basis for terminating provider participation, the role of documentary evidence in determining noncompliance, and documentation and notice requirements for terminations; the procedures for reconsideration, hearings, and appeals; and the impact of changes in provider status or services, including the requirements for distinct-part certifications for skilled nursing facilities, changes in designated bed sizes/locations, and changes in ownership.
Program Administration and Fiscal Management, Chapter 4, State Operations Manual (SOM)
Chapter 4, “Program Administration and Fiscal Management,” explains the core roles and responsibilities of the federal government and the state survey agencies throughout the survey-and-certification process. For example, this chapter covers the deeming and waiver of nurse aide training and competency evaluation requirements, as well as curriculum requirements for those programs; nurse aide registries; and Resident Assessment Instrument specifications, including state-specified RAI requirements.
Complaint Procedures, Chapter 5, State Operations Manual (SOM)
Chapter 5, “Complaint Procedures,” reviews the purpose of the complaint/incident process; how state agencies should manage the intake of complaints; how state agencies should prioritize complaints as immediate jeopardy—high, medium, or low, administrative review/offsite investigation, referral—immediate or other, or no action necessary; and maximum time frames for onsite investigations. Specific sections related to nursing homes include: investigation of complaints for nursing homes; action on complaints of resident neglect and abuse, and misappropriation of resident property; reporting findings of abuse, neglect, or misappropriation of property to the nurse aide registry; reporting abuse to law enforcement and the Medicaid fraud control unit; and post-survey certification actions for nursing homes.
Survey and Enforcement Process for SNFs and NFs, Chapter 7, State Operations Manual (SOM)
Note: On June 15, 2018, CMS issued an advance copy of finalized revisions to Chapter 7 via QSO memo 18-18-NH. The policies are now in effect, so providers should refer to the advance copy until CMS posts an official update to Chapter 7. These revisions address the final revised policies regarding the immediate imposition of federal remedies. Substantive revisions to the prior Immediate Imposition of Federal Remedies guidance include:
- When the current survey identifies Immediate Jeopardy (IJ) that does not result in serious injury, harm, impairment or death, the CMS Regional Offices may determine the most appropriate remedy;
- CMS clarified that Past Noncompliance deficiencies (as described in §7510.1 of this chapter) are not included in the criteria for Immediate Imposition of Remedies; and,
- For Special Focus Facilities (SFFs), S/S level “F” citations under tags F812, F813 or F814 are excluded from immediate imposition of remedies
Chapter 7, “Survey and Enforcement Process for Skilled Nursing Facilities and Nursing Facilities,” is the core “how to” chapter of the State Operations Manual chapter for nursing home surveys and enforcement actions by state agencies. The chapter opens with definitions of a skilled nursing facility and a nursing facility, and explains special waivers that may apply to SNFs and NFs, such as a waiver of the seven-day RN Requirement for SNFs. In addition, this chapter covers:
The survey process. Topics in these sections include but are not limited to:
- The size and composition of the survey team, as well as survey frequency and timing;
- The survey protocol for different survey types, including initial certifications, resurveys, abbreviated standard surveys, and state monitoring visits;
- The rules for substandard quality of care and extended and partial extended surveys;
- Informal dispute resolution and independent informal dispute resolution;
- Actions to be taken when a facility is not in substantial compliance, including when immediate jeopardy exists;
- Provider appeal of a certification of noncompliance;
- Acceptable plans of correction;
- State survey agency notice requirements in various scenarios;
- Enforcement actions and appropriate timing of those actions when immediate jeopardy exists or does not exist; and
- The rules for readmitting a SNF or dually participating facility to Medicare or Medicaid after termination.
The enforcement process. Topics in these sections include but are not limited to:
- A listing of potential enforcement remedies and mandatory enforcement remedies;
- Factors surveyors should use when selecting remedies; and
- Life Safety Code enforcement guidelines.
Remedies. Topics in these sections include but are not limited to:
- A directed plan of correction;
- Directed inservice training;
- State monitoring;
- Denial of payment for all New Medicare and Medicaid admissions; and
- Denial of payment for all Medicare and Medicaid residents.
Civil money penalties. Topics in these sections include but are not limited to:
- How the amount of a CMP should be determined;
- The duration of a CMP;
- When a CMP is due and payable;
- The rules for temporary management; and
- Termination procedures when a facility isn’t in substantial compliance.
Program management. Topics in these sections include but are not limited to:
- Consistency of state survey results;
- State/federal disagreements about timing and choice of remedies; and
- Nurse aide training and competency evaluation program and competency evaluation program disapprovals.
Disclosure. Topics in these sections include but are not limited to:
- Time periods for disclosing SNF/NF information;
- Information that must be given to the long-term care ombudsman; and
- Information that must be furnished to the state by facilities with substandard quality of care.
Life Safety Code Survey Procedures, Appendix I, State Operations Manual (SOM)
Appendix I, “Survey Procedures for Life Safety Code Surveys,” reviews the six survey tasks for surveyors during a life safety code survey: offsite survey preparation, entrance conference/onsite preparation, orientation tour, information gathering, information analysis and decision-making, and the exit conference. This section also addresses complaint investigations and survey revisits.
Long Term Care Survey Process (LTCSP) Procedure Guide
As of Nov. 28, 2017, CMS has made Appendix P inaccessible. The Long-term Care Survey Process (LTCSP) Procedure Guide has replaced Appendix P as the procedural and technical guide for conducting all long-term care standard surveys. In addition, CMS plans to revise Chapter 7 of the SOM to include survey policy. For more information about these changes, see survey-and-certification memo S&C:18-05-NH.
CFR Surveyor Interpretive Guidance for Long-term Care Facilities (NFs and SNFs), Appendix PP, State Operations Manual (SOM)
Appendix PP, “Guidance to Surveyors for Long-term Care Facilities,” contains the relevant sections of the Code of Federal Regulations (42 CFR 483), the corresponding F-tags (F540 - F949
), and the interpretive guidelines that surveyors use in assessing nursing facility compliance with the Medicare/Medicaid conditions of participation. Appendix PP corresponds with the nationwide implementation of the Long-Term Care Survey Process (LTCSP), including a new F-tag numbering system, and the Phase 2 rollout of the revised Medicare/Medicaid conditions of participation (aka the reform of requirements). These instructions cover the full range of operational, physical plant, and quality issues that surveyors assess. For example, there are sections on:
Resident rights, including but not limited to telephone, mail, personal property, and discharge rights;Freedom from abuse, neglect, and exploitation, including but not limited to restraints and staff treatment of residents;
Quality of life, including but not limited to activities of daily living, activities, and CPR;
Resident assessments, including but not limited to admission orders, comprehensive assessment, coordination, assessment accuracy, and significant change notifications;
Quality of care, including but not limited to nutrition, hydration, bowel/bladder incontinence, and pain management;
Nursing services, including but not limited to sufficient staff, competent staff, and registered nurses;
Food and nutrition services, including but not limited to staffing, therapeutic diets, assistive devices, and paid feeding assistants;
Physician services, including but not limited to physician supervision, physician visits, and physician delegation of tasks in SNFs;
Specialized rehabilitative services;
Pharmacy services, including but not limited to drug regimen review;
Infection control, including but not limited to linens;
Physical environment, including but not limited to emergency power and the resident call system; and
Administration, including but not limited to licensure, Payroll-Based Journal, medical director requirements, and the facility assessment.
Access a crosswalk between the old and new F-tags here
. Access the LTCSP entrance conference worksheet, provider matrix, Critical Element Pathways, Facility Task Pathways, and other tools here
Appendix Z, Emergency Preparedness Final Rule Interpretive Guidelines and Survey Procedures
On September 16, 2016, the final rule on Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers was published (Federal Register Vol. 81, No. 180). This rule affects all NFs/SNFs. The rule became effective on Nov. 15, 2016 and was implemented on Nov. 15, 2017. Appendix Z contains the interpretive guidelines and survey procedures for the Emergency Preparedness Final Rule.
Surveyor Guidelines for Determining Immediate Jeopardy, Appendix Q, State Operations Manual (SOM)
Appendix Q, “Guidelines for Determining Immediate Jeopardy,” provides surveyors with detailed steps for determining whether an immediate jeopardy exists. These instructions include triggers for further review, examples of immediate jeopardy, and procedures to follow when immediate jeopardy is cited.
Temporary Enforcement Delays
Survey-and-certification memo S&C:18-04-NH explains important information on: (1) temporary enforcement delays for certain F-tags associated with Phase 2 of the rollout of the Reform of Requirements for Long-term Care Final Rule, and (2) changes to Nursing Home Compare. Providers should review the memo for complete details, but the basics are covered below.
First, CMS will provide an 18-month moratorium on the imposition of certain enforcement remedies for specific Phase 2 requirements when surveyors conduct surveys using the new survey process effective Nov. 28, 2017, in order to educate facilities about specific new Phase 2 standards. The following F-tags are included in this moratorium:
F655 (Baseline Care Plan); §483.21(a)(1)-(a)(3)
F740 (Behavioral Health Services); §483.40
F741 (Sufficient/Competent Direct Care/Access Staff-Behavioral Health); §483.40(a)(1)- (a)(2)
F758 (Psychotropic Medications) related to PRN Limitations §483.45(e)(3)-(e)(5)
F838 (Facility Assessment); §483.70(e)
F881 (Antibiotic Stewardship Program); §483.80(a)(3)
F865 (QAPI Program and Plan) related to the development of the QAPI Plan; §483.75(a)(2) and,
F926 (Smoking Policies). §483.90(i)(5)
Nursing Home Compare changes include the following:
Freezing Health Inspection Star Ratings for any surveys occurring between November 28, 2017, and November 27, 2018.
Publishing the survey findings of facilities surveyed under the new survey process, but not incorporating these findings into calculations for the Five-Star Quality Rating System for 12 months. CMS will add indicators to NHC that summarize survey findings.
Changing in early 2018 the Health Inspection Star Ratings so that they’re based on the two most recent cycles of findings for standard health inspection surveys and the two most recent years of complaint inspections.