Selected extract from the HCFA Final Rule Regulation, published 12-23-97. Establishes implementation dates and penalties for non-compliance.
RAI FINAL RULE REGULATION
SUMMARY: This final rule establishes a resident assessment instrument for use by long term care facilities participating in the Medicare and Medicaid programs when conducting a periodic assessment of a resident's functional capacity. The resident assessment instrument (RAI) consists of a minimum data set (MDS) of elements, common definitions, and coding categories needed to perform a comprehensive assessment of a long term care facility resident. A State may choose to use the Federally established resident assessment instrument or an alternate instrument that is designed by the State and approved by us.
These regulations establish guidelines for use of the data set and designation of the assessment instrument. The provisions contained in these regulations implement statutory requirements. The resident assessment instrument is intended to produce a comprehensive, accurate, standardized, reproducible assessment of each long term care facility resident's functional capacity.
EFFECTIVE DATE: Except for Secs. 483.20(f) and 483.315(h), these regulations are effective March 23, 1998. Sections 483.20(f) Facility computerization requirements and 483.315(h) State computerization requirements are effective June 22, 1998.
FOR FURTHER INFORMATION CONTACT: Cindy Hake, (410) 786-3404.
SUPPLEMENTARY INFORMATION:
I. Background
On December 28, 1992, we published in the Federal Register, at 57 FR 61614, a proposed rule with an opportunity for public comment, ``Resident Assessment in Long Term Care Facilities,'' which established a resident assessment instrument that all long term care facilities participating in the Medicare and Medicaid programs must use when conducting an assessment of a resident's functional capacity. We proposed that a State may choose to use the Federally established resident assessment instrument or an alternate instrument that is designed by the State and approved by us. We proposed that a facility must enter information from the resident assessment into a computer, in accordance with HCFA-specified formats. At least monthly, the facility must transmit electronically the information contained in each resident assessment to the State.
The resident assessment instrument would consist of a minimum data set (MDS) of screening and assessment elements, including common definitions and coding categories for use by a facility in performing a comprehensive assessment of a long term care facility resident. In addition to containing identifying information such as name, birthdate, and occupation, the MDS consists of standardized items that assess, for example, a resident's communication patterns, cognitive patterns, physical functioning and structural problems, health conditions, and medications. The proposed rule established guidelines for use of the data set, and designated one or more assessment instruments that a State may require a facility to use.
We proposed to add a new Sec. 483.315, which would require a State to specify for use in long term care facilities within the State either the HCFA-designated resident assessment instrument or an alternate instrument. The State would request and receive approval from us before implementing or modifying an alternate instrument. The uniform MDS was included in Sec. 483.315(b). We also provided as attachments to the regulations the utilization guidelines for the resident assessment instrument, MDS common definitions, and resident assessment protocols (RAPs).
PART 483--REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES
1. The authority citation for part 483 continues to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
2. In Sec. 483.20, paragraphs (d) through (f) are redesignated as (k) through (m), respectively, paragraphs (b) and (c) are revised and new paragraphs (d) through (j) are added to read as follows:
Sec. 483.20 Resident assessment.
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(b) Comprehensive assessments.
(1) Resident assessment instrument. A facility must make a comprehensive assessment of a resident's needs, using the resident assessment instrument (RAI) specified by the State. The assessment must include at least the following:
(i) Identification and demographic information.
(ii) Customary routine.
(iii) Cognitive patterns.
(iv) Communication.
(v) Vision.
(vi) Mood and behavior patterns.
(vii) Psychosocial well-being.
(viii) Physical functioning and structural problems.
(ix) Continence.
(x) Disease diagnoses and health conditions.
(xi) Dental and nutritional status.
(xii) Skin condition.
(xiii) Activity pursuit.
(xiv) Medications.
(xv) Special treatments and procedures.
(xvi) Discharge potential.
(xvii) Documentation of summary information regarding the additional assessment performed through the resident assessment protocols.
(xviii) Documentation of participation in assessment. The assessment process must include direct observation and communication with the resident, as well as communication with licensed and nonlicensed direct care staff members on all shifts.
(2) When required. A facility must conduct a comprehensive assessment of a resident as follows:
(i) Within 14 calendar days after admission, excluding readmissions in which there is no significant change in the resident's physical or mental condition. (For purposes of this section, ``readmission'' means a return to the facility following a temporary absence for hospitalization or for therapeutic leave.)
(ii) Within 14 calendar days after the facility determines, or should have determined, that there has been a significant change in the resident's physical or mental condition. (For purposes of this section, a ``significant change'' means a major decline or improvement in the resident's status that will not normally resolve itself without further intervention by staff or by implementing standard disease-related clinical interventions, that has an impact on more than one area of the resident's health status, and requires interdisciplinary review or revision of the care plan, or both.)
(iii) Not less often than once every 12 months.
(c) Quarterly review assessment. A facility must assess a resident using the quarterly review instrument specified by the State an approved by HCFA not less frequently than once every 3 months.
(d) Use. A facility must maintain all resident assessments completed within the previous 15 months in the resident's active record and use the results of the assessments to develop, review, and revise the resident's comprehensive plan of care.
(e) Coordination. A facility must coordinate assessments with the preadmission screening and resident review program under Medicaid in part 483, subpart C to the maximum extent practicable to avoid duplicative testing and effort.
(f) Automated data processing requirement. (1) Encoding data. Within 7 days after a facility completes a resident's assessment, a facility must encode the following information for each resident in the facility:
(i) Admission assessment.
(ii) Annual assessment updates.
(iii) Significant change in status assessments.
(iv) Quarterly review assessments.
(v) A subset of items upon a resident's transfer, reentry, discharge, and death.
(vi) Background (face-sheet) information, if there is no admission assessment.
(2) Transmitting data. Within 7 days after a facility completes a resident's assessment, a facility must be capable of transmitting to the State information for each resident contained in the MDS in a format that conforms to standard record layouts and data dictionaries, and that passes standardized edits defined by HCFA and the State.
(3) Monthly transmittal requirements. A facility must electronically transmit, at least monthly, encoded, accurate, complete MDS data to the State for all assessments conducted during the previous month, including the following:
(i) Admission assessment.
(ii) Annual assessment.
(iii) Significant change in status assessment.
(iv) Significant correction of prior full assessment.
(v) Significant correction of prior quarterly assessment.
(vi) Quarterly review.
(vii) A subset of items upon a resident's transfer, reentry, discharge, and death.
(viii) Background (face-sheet) information, for an initial transmission of MDS data on a resident that does not have an admission assessment.
(4) Data format. The facility must transmit data in the format specified by HCFA or, for a State which has an alternate RAI approved by HCFA, in the format specified by the State and approved by HCFA.
(5) Resident-identifiable information. (i) A facility may not release information that is resident-identifiable to the public.
(ii) The facility may release information that is resident- identifiable to an agent only in accordance with a contract under which the agent agrees not to use or disclose the information except to the extent the facility itself is permitted to do so.
(g) Accuracy of assessments. The assessment must accurately reflect the resident's status.
(h) Coordination. A registered nurse must conduct or coordinate each assessment with the appropriate participation of health professionals.
(i) Certification. (1) A registered nurse must sign and certify that the assessment is completed.
(2) Each individual who completes a portion of the assessment must sign and
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certify the accuracy of that portion of the assessment.
(j) Penalty for falsification. (1) Under Medicare and Medicaid, an individual who willfully and knowingly--
(i) Certifies a material and false statement in a resident assessment is subject to a civil money penalty of not more than $1,000 for each assessment; or
(ii) Causes another individual to certify a material and false statement in a resident assessment is subject to a civil money penalty of not more than $5,000 for each assessment.
(2) Clinical disagreement does not constitute a material and false statement.
* * * * *
3. Subpart F consisting of Sec. 483.315 is added to read as
follows:
Subpart F--Requirements That Must be Met by States and State Agencies, Resident Assessment
Sec. 483.315 Specification of resident assessment instrument.
(a) Statutory basis. Sections 1819(e)(5) and 1919(e)(5) of the Act require that a State specify the resident assessment instrument (RAI) to be used by long term care facilities in the State when conducting initial and periodic assessments of each resident's functional capacity, in accordance with Sec. 483.20.
(b) State options in specifying an RAI. The RAI that the State specifies must be one of the following:
(1) The instrument designated by HCFA.
(2) An alternate instrument specified by the State and approved by HCFA, using the criteria specified in the State Operations Manual issued by HCFA (HCFA Pub. 7) which is available for purchase through the National Technical Information Service, 5285 Port Royal Rd., Springfield, VA 22151.
(c) State requirements in specifying an RAI.
(1) Within 30 days after HCFA notifies the State of the HCFA- designated RAI or changes to it, the State must do one of the following:
(i) Specify the HCFA-designated RAI.
(ii) Notify HCFA of its intent to specify an alternate instrument.
(2) Within 60 days after receiving HCFA approval of an alternate RAI, the State must specify the RAI for use by all long term care facilities participating in the Medicare and Medicaid programs.
(3) After specifying an instrument, the State must provide periodic educational programs for facility staff to assist with implementation of the RAI.
(4) A State must audit implementation of the RAI through the survey process.
(5) A State must obtain approval from HCFA before making any modifications to its RAI.
(6) A State must adopt revisions to the RAI that are specified by HCFA.
(d) HCFA-designated RAI. The HCFA-designated RAI is published in the State Operations Manual issued by HCFA (HCFA Pub. 7), as updated periodically, and consists of the following:
(1) The minimum data set (MDS) and common definitions.
(2) The resident assessment protocols (RAPs) and triggers that are necessary to accurately assess residents, established by HCFA.
(3) The quarterly review, based on a subset of the MDS specified by HCFA.
(4) The requirements for use of the RAI that appear at Sec. 483.20.
(e) Minimum data set (MDS). The MDS includes assessment in the following areas:
(1) Identification and demographic information, which includes information to identify the resident and facility, the resident's residential history, education, the reason for the assessment, guardianship status and information regarding advance directives, and information regarding mental health history.
(2) Customary routine, which includes the resident's lifestyle prior to admission to the facility.
(3) Cognitive patterns, which include memory, decision making, consciousness, behavioral measures of delirium, and stability of condition.
(4) Communication, which includes scales for measuring hearing and communication skills, information on how the resident expresses himself or herself, and stability of communicative ability.
(5) Vision pattern, which includes a scale for measuring vision and vision problems.
(6) Mood and behavior patterns, which include scales for measuring behavioral indicators and symptoms, and stability of condition.
(7) Psychosocial well-being, which includes the resident's interpersonal relationships and adjustment factors.
(8) Physical functioning and structural problems, which contains scales for measuring activities of daily living, mobility, potential for improvement, and stability of functioning.
(9) Continence, which includes assessment scales for bowel and
bladder incontinence, continence patterns, interventions, and stability
of continence status.
(10) Disease diagnoses and health conditions, which includes active
medical diagnoses, physical problems, pain assessment, and stability of condition.
(11) Dental and nutritional status, which includes information on height and weight, nutritional problems and accommodations, oral care and problems, and measure of nutritional intake.
(12) Skin condition, which includes current and historical assessment of skin problems, treatments, and information regarding foot care.
(13) Activity pursuit, which gathers information on the resident's activity preferences and the amount of time spent participating in activities.
(14) Medications, which contains information on the types and numbers of medications the resident receives.
(15) Special treatments and procedures, which includes measurements of therapies, assessment of rehabilitation / restorative care, special programs and interventions, and information on hospital visits and physician involvement.
(16) Discharge potential, which assesses the possibility of discharging the resident and discharge status.
(17) Documentation of summary information regarding the additional assessment performed through the resident assessment protocols.
(18) Documentation of participation in assessment.
(f) Resident assessment protocols (RAPs). At a minimum, the RAPs address the following domains:
(1) Delirium.
(2) Cognitive loss.
(3) Visual function.
(4) Communication.
(5) ADL functional/rehabilitation potential.
(6) Urinary incontinence and indwelling catheter.
(7) Psychosocial well-being.
(8) Mood state.
(9) Behavioral symptoms.
(10) Activities.
(11) Falls.
(12) Nutritional status.
(13) Feeding tubes.
(14) Dehydration/fluid maintenance.
(15) Dental care.
(16) Pressure ulcers.
(17) Psychotropic drug use.
(18) Physical restraints.
(g) Criteria for HCFA approval of alternate instrument. To receive HCFA approval, a State's alternate instrument must use the standardized format, organization, item labels and definitions, and instructions specified by HCFA in the latest issuance of the State Operations Manual issued by HCFA (HCFA Pub. 7).
(h) State MDS collection and data base requirements. (1) As part of facility
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survey responsibilities, the State must establish and maintain an MDS Database, and must do the following:
(i) Use a system to collect, store, and analyze data that is developed or approved by HCFA.
(ii) Obtain HCFA approval before modifying any parts of the HCFA standard system other than those listed in paragraph (h)(2) of this section (which may not be modified).
(iii) Specify to a facility the method of transmission of data to the State, and instruct the facility on this method.
(iv) Upon receipt of data from a facility, edit the data, as specified by HCFA, and ensure that a facility resolves errors.
(v) At least monthly, transmit to HCFA all edited MDS records received during that period, according to formats specified by HCFA, and correct and retransmit rejected data as needed.
(vi) Analyze data and generate reports, as specified by HCFA.
(2) The State may not modify any aspect of the standard system that pertains to the following:
(i) Standard approvable RAI criteria specified in the State Operations Manual issued by HCFA (HCFA Pub. 7) (MDS item labels and definitions, RAPs and utilization guidelines).
(ii) Standardized record formats and validation edits specified in the State Operations Manual issued by HCFA (HCFA Pub. 7).
(iii) Standard facility encoding and transmission methods specified in the State Operations Manual issued by HCFA (HCFA Pub. 7).
(i) State identification of agency that collects RAI data. The
State must identify the component agency that collects RAI data, and ensure that this agency restricts access to the data except for the following:
(1) Reports that contain no resident-identifiable data.
(2) Transmission of data and reports to HCFA.
(3) Transmission of data and reports to the State agency that conducts surveys to ensure compliance with Medicare and Medicaid participation requirements, for purposes related to this function.
(4) Transmission of data and reports to the State Medicaid agency for purposes directly related to the administration of the State Medicaid plan.
(5) Transmission of data and reports to other entities only when authorized as a routine use by HCFA.
(j) Resident-identifiable data. (1) The State may not release information that is resident-identifiable to the public.
(2) The State may not release RAI data that is resident- identifiable except in accordance with a written agreement under which the recipient agrees to be bound by the restrictions described in paragraph (i) of this section.
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical Assistance Program; and No. 93.773, Medicare-- Hospital Insurance)
Dated: December 3, 1997.
Nancy-Ann Min DeParle,
Administrator, Health Care Financing Administration.
Dated: December 9, 1997.
Donna E. Shalala,
Secretary.
[FR Doc. 97-32828 Filed 12-22-97; 8:45 am]
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