Survey, Certification, and Enforcement Procedures

Definitions.

This provision defines key terms used in Medicare survey, certification, and enforcement procedures for providers and suppliers.

State survey agency review: Statutory provisions.

This provision outlines the statutory authority for state survey agencies to determine provider compliance and the role of national accreditation in the survey process.

Long term care survey forms, Part A.

This provision identifies the survey forms used for assessing compliance in long-term care settings.

Basis and scope.

This provision establishes the regulatory and statutory basis for the accreditation of home infusion therapy suppliers.

Definitions.

This provision defines terms specific to the accreditation of home infusion therapy suppliers, including immediate jeopardy and qualified supplier criteria.

Application and reapplication procedures for national home infusion therapy accrediting organizations.

This provision outlines the application, documentation, and operational requirements for national accrediting organizations seeking CMS approval to accredit home infusion therapy suppliers.

Resubmitting a request for reapproval.

Specifies the requirements for a home infusion therapy accrediting organization to resubmit an application for CMS approval following a denial or voluntary withdrawal.

Public notice and comment.

Outlines the CMS process for publishing Federal Register notices regarding the approval or denial of home infusion therapy accreditation programs.

Release and use of home infusion therapy accreditation surveys.

Mandates that home infusion therapy suppliers agree to release accreditation survey results to CMS and defines the conditions for public disclosure of such information.

Ongoing review of home infusion therapy accrediting organizations.

This provision outlines the CMS process for the ongoing performance and comparability review of home infusion therapy accrediting organizations, including procedures for program approval, corrective action, and withdrawal of status.

Ongoing responsibilities of a CMS-approved home infusion therapy accrediting organization.

This provision outlines the ongoing reporting and notification requirements for CMS-approved home infusion therapy accrediting organizations regarding survey results, accreditation decisions, and immediate jeopardy findings.

Onsite observations of home infusion therapy accrediting organization operations.

This provision authorizes CMS to conduct onsite inspections of home infusion therapy accrediting organizations to verify compliance with policies and procedures.

Voluntary and involuntary termination.

This provision establishes the procedures for the termination of CMS-approved home infusion therapy accreditation programs and the resulting impact on supplier accreditation and payment status.

Long term care survey forms, Part B.

This provision is a placeholder for long term care survey forms.

Reconsideration.

This provision outlines the reconsideration and hearing process for home infusion therapy accrediting organizations that disagree with CMS adverse determinations.

State survey agency functions.

This provision defines the functions of state and local agencies in conducting surveys, validation surveys, and making recommendations regarding provider agreements.

Procedural guidelines.

This provision establishes the procedural guidelines for conducting surveys of Skilled Nursing Facilities and Intermediate Care Facilities, including task-based methodologies for assessing compliance with care and operational standards.

Basis and scope.

This provision establishes the statutory basis for hospice program requirements and the authority for surveys to determine compliance with Medicare conditions of participation.

Definitions.

This section provides definitions for terms used in hospice survey and certification procedures, including survey types, deficiency levels, and the Special Focus Program.

Hospice program: surveys and hotline.

This provision mandates the frequency of standard surveys for hospice programs and requires state agencies to maintain a toll-free hotline for complaints and information.

Surveyor qualifications and prohibition of conflicts of interest.

This section outlines the minimum training requirements for hospice surveyors and prohibits individuals with conflicts of interest from participating in surveys.

Survey teams.

This provision requires that standard hospice surveys be conducted by a multidisciplinary team of professionals, including a registered nurse.

Consistency of survey results.

This provision requires survey agencies and accrediting organizations to submit a corrective action plan to CMS if their disparity rates exceed established thresholds.

Informal dispute resolution (IDR).

This section outlines the process for hospice programs to dispute condition-level survey findings through an informal dispute resolution process.

Hospice Special Focus Program (SFP).

This provision details the selection, survey, and termination criteria for the Hospice Special Focus Program, which targets poor-performing hospice programs for increased oversight.

Care guidelines.

This provision is a placeholder for care guidelines.

Effect of survey agency certification.

This provision clarifies that state survey agency certifications are recommendations to CMS, which makes the final determination on provider eligibility and deemed status.

Statutory basis.

This provision establishes the statutory authority for the Secretary to take enforcement actions against hospice programs to correct deficiencies.

Definitions.

This provision defines key terms used in the hospice enforcement subpart, including immediate jeopardy, plan of correction, and temporary management.

General provisions.

This provision outlines the purpose of remedies, the basis for their imposition, notification requirements, and appeal rights for hospice programs.

Factors to be considered in selecting remedies.

This provision lists the factors CMS considers when selecting enforcement remedies for hospice programs, such as the presence of immediate jeopardy and compliance history.

Available remedies.

This provision identifies the specific enforcement remedies available to CMS for hospice programs, including civil money penalties and temporary management.

Action when deficiencies pose immediate jeopardy.

This provision specifies the actions CMS takes when hospice deficiencies pose immediate jeopardy, including termination and patient transfer requirements.

Action when deficiencies are at the condition-level but do not pose immediate jeopardy.

This provision outlines the enforcement actions and termination timeframes for hospice programs with condition-level deficiencies that do not pose immediate jeopardy.

Temporary management.

This provision details the application, procedures, duration, and salary requirements for the temporary management of a hospice program.

Suspension of payment for all new patient admissions.

This provision outlines the procedures and duration for suspending Medicare payments for new patient admissions to a hospice program due to non-compliance.

Civil money penalties.

This provision establishes the criteria, calculation methods, procedures, and payment requirements for civil money penalties imposed on hospice programs for noncompliance with conditions of participation.

Directed plan of correction.

CMS may impose a directed plan of correction on a hospice program that has condition-level deficiencies or fails to submit an acceptable plan of correction.

Directed in-service training.

CMS may require hospice staff to attend in-service training when condition-level deficiencies are identified and education is deemed likely to correct them.

Continuation of payments to a hospice program with deficiencies.

CMS may continue payments to a hospice program with non-immediate jeopardy deficiencies for up to 6 months provided specific criteria are met.

Termination of provider agreement.

CMS may terminate a hospice program's provider agreement for failure to comply with conditions of participation or other specified enforcement criteria.

Loss of accreditation.

When an accrediting organization terminates a provider due to non-compliance, the State Agency must conduct a full review in a timely manner.

Effect of QIO review.

Quality Improvement Organization (QIO) review activities are conducted in lieu of certain utilization review and evaluation requirements for health care institutions.

Documentation of findings.

State agencies must document findings regarding compliance with conditions of participation, including specific deficiencies and provider responses.

Statutory basis.

This part is based on the indicated provisions of the following sections of the Act.

Periodic review of compliance and approval.

State survey agencies must periodically resurvey providers to ascertain compliance and confirm the correction of deficiencies.

Reconsideration.

Accreditation organizations and states may request reconsideration of adverse determinations regarding deeming authority or laboratory program approval.

Withdrawal of request for reconsideration.

A requestor may withdraw its request for reconsideration at any time before the issuance of a reconsideration determination.

Right to informal hearing.

CMS provides accreditation organizations or State laboratory programs the opportunity for an informal hearing in response to a request for reconsideration.

Informal hearing procedures.

This section establishes the procedures for conducting an informal reconsideration hearing, including notice requirements, participation, and the role of the hearing officer.

Hearing officer's findings.

The hearing officer must present findings and recommendations to the requesting organization within 30 days of the hearing, including findings of fact and legal conclusions.

Final reconsideration determination.

The CMS Administrator may review the hearing officer's decision and issue a final reconsideration determination, which is published in the Federal Register.

Certification of noncompliance.

State agencies must certify when a provider or supplier is not in compliance with conditions of participation or coverage, and providers have the right to request review of such determinations.

Determining compliance.

This section outlines the principles for determining compliance with federal requirements, emphasizing the use of survey processes and direct observation of care.

Providers or suppliers, other than SNFs, NFs, HHAs, and Hospice programs with deficiencies.

Providers found deficient in standards must submit an acceptable plan of correction to achieve compliance within a reasonable period, or face potential enforcement actions.

Conditions of participation, conditions for coverage, conditions for certification and long term care requirements.

This section sets the basic rules for Medicare participation, requiring providers to meet statutory definitions and comply with applicable conditions of participation.

Revisit user fee for revisit surveys.

CMS assesses user fees for revisit surveys conducted to evaluate the correction of previously cited deficiencies, with specific criteria for fee determination and collection.

Statutory basis.

This provision establishes the statutory authority for surveying skilled nursing and nursing facilities to determine Medicare and Medicaid program participation.

Definitions.

As used in this subpart—

State plan requirement.

This provision outlines state plan requirements for nursing facility survey programs, including mandatory and optional enforcement remedies for noncompliance.

Standard surveys.

This provision defines the components of a standard survey for skilled nursing and nursing facilities, including quality of care indicators and resident rights reviews.

Unannounced surveys.

This provision mandates that standard surveys be unannounced and establishes penalties for individuals who provide advance notice of survey scheduling.

Survey frequency.

This provision specifies the required frequency for standard surveys, special surveys, and complaint investigations for nursing facilities.

Extended survey.

This provision defines the purpose and scope of extended surveys conducted when substandard quality of care is identified during a standard survey.

Consistency of survey results.

This provision requires the implementation of programs to measure accuracy and improve consistency in the application of survey results and enforcement remedies.

Survey teams.

This provision outlines requirements for survey team composition, surveyor training, and disqualification criteria to ensure objective survey conduct.

Inadequate survey performance.

This provision defines the criteria for identifying inadequate survey performance by state survey agencies.

Sanctions for inadequate survey performance.

This provision outlines the sanctions and corrective actions CMS may take when a state survey agency demonstrates inadequate survey performance.

Disclosure of results of surveys and activities.

This provision mandates the public disclosure of survey and certification results, plans of correction, and ownership information for skilled nursing and nursing facilities.

Certification of compliance or noncompliance.

This provision establishes the rules for certifying compliance or noncompliance for long-term care facilities and the resulting enforcement actions.

Informal dispute resolution.

This provision outlines the process for facilities to informally dispute survey findings and deficiency citations.

Investigation of complaints of violations and monitoring of compliance.

This provision establishes procedures for state survey agencies to investigate complaints and conduct on-site monitoring of long-term care facilities.

Educational programs.

This provision requires states to conduct periodic educational programs for staff and residents regarding survey, certification, and enforcement processes.

Action on complaints of resident neglect and abuse, and misappropriation of resident property.

This provision outlines the state's requirements for investigating and reporting allegations of resident abuse, neglect, or misappropriation of property, including notification and hearing procedures.

General rules for a CMS-approved accreditation program for providers and suppliers.

This provision establishes the requirements for national accrediting organizations seeking CMS approval and the process for granting deemed status to providers.

Statutory basis.

This provision identifies the statutory authority for the Secretary or the State to impose remedies when a facility is not in substantial compliance with participation requirements.

Definitions.

This provision defines key terms used in the enforcement subpart, including noncompliance, new admission, and plan of correction.

General provisions.

This provision outlines the purpose of enforcement remedies, the requirement for plans of correction, and notification procedures for enforcement actions.

Factors to be considered in selecting remedies.

This provision describes the factors CMS and the state use to determine the seriousness of deficiencies and select appropriate enforcement remedies.

Available remedies.

This provision lists the various enforcement remedies available to CMS and the state, including temporary management, civil money penalties, and directed plans of correction.

Selection of remedies.

This provision outlines the categories of enforcement remedies available to CMS and States for facility noncompliance and the criteria for their application.

Action when there is immediate jeopardy.

This provision mandates specific enforcement actions, including termination or temporary management, when a facility's noncompliance poses immediate jeopardy to resident health or safety.

Action when there is no immediate jeopardy.

This provision establishes the enforcement procedures and conditions for continued participation when a facility is not in substantial compliance but does not pose immediate jeopardy.

Action when there is repeated substandard quality of care.

This provision mandates specific enforcement remedies when a facility is cited for substandard quality of care on three consecutive standard surveys.

Temporary management.

This provision defines the role, qualifications, and payment requirements for a temporary manager appointed by CMS or the State to correct facility deficiencies.

Denial of payment for all new admissions.

This provision outlines the conditions under which CMS or the State may or must deny payment for new admissions as an enforcement remedy for noncompliance.

Secretarial authority to deny all payments.

CMS may deny payment for all Medicare and Medicaid residents in a facility that fails to meet participation requirements until substantial compliance is achieved.

State monitoring.

A state monitor must be assigned to oversee the correction of deficiencies and protect residents in facilities with repeated substandard quality of care.

Directed plan of correction.

CMS or the State survey agency may require a facility to implement a directed plan of correction to address deficiencies within specified timeframes.

Directed inservice training.

CMS or the State may require facility staff to attend directed inservice training when a pattern of deficiencies indicates that education is likely to correct noncompliance.

Transfer of residents, or closure of the facility and transfer of residents.

The State has authority to transfer residents or close a facility in emergencies, and must arrange for safe transfers when a provider agreement is terminated.

Civil money penalties: Basis for imposing penalty.

CMS or the State may impose civil money penalties on a per-day or per-instance basis for noncompliance with participation requirements.

Civil money penalties imposed by CMS and independent informal dispute resolution: for SNFS, dually-participating SNF/NFs, and NF-only facilities.

This provision establishes the process for independent informal dispute resolution and the collection and escrow of civil money penalties imposed by CMS.

Civil money penalties imposed by the State: NF-only.

This provision outlines the procedures for the State to initiate collection of civil money penalties for nursing facilities, including hearing request timelines and waiver conditions.

Civil money penalties: Uses and approval of civil money penalties imposed by CMS.

This provision outlines the requirements for the use and CMS approval of civil money penalty funds to protect or improve the quality of care and life for residents.

Civil money penalties: Notice of penalty.

This provision specifies the required content and delivery procedures for notices of civil money penalties issued by CMS or the State.

Civil money penalties: Waiver of hearing, reduction of penalty amount.

This provision establishes the conditions for waiving the right to a hearing and the associated reduction in civil money penalty amounts.

Civil money penalties: Amount of penalty.

This provision defines the ranges, calculation factors, and reduction criteria for civil money penalties imposed for facility noncompliance.

Civil money penalties: Effective date and duration of penalty.

This provision specifies the accrual, duration, and collection procedures for civil money penalties imposed on facilities.

Civil money penalties: Due date for payment of penalty.

This provision establishes the timelines, interest calculations, and collection procedures for civil money penalties imposed on facilities.