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CRN Conditions of Coverage. What RD’s Need to Know. Objectives. Review background & rationale for changes to the current ESRD regulations. Discuss major changes impacting the RD from the current to the new regulations. 2. Rationale for ESRD Regulation Changes.

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crn conditions of coverage

CRN Conditions of Coverage

What RD’s Need to Know


Review background & rationale for changes to the current ESRD regulations.

Discuss major changes impacting the RD from the current to the new regulations


rationale for esrd regulation changes
Rationale for ESRD Regulation Changes

•Increasing realization of the need for regulatory support for an outcomes focus across provider types

• Needed to drive improvements in care

Critical if CMS moves to value-based pricing or pay for performance

Necessary if CMS moves to bundled reimbursement for ESRD care


reasons for change
Reasons for Change

Changes in technology

Differences in care delivery

Evidence Based Practice: ESRD community coming to consensus on minimum standards of care

QAPI: accepted process of quality assessment across provider types

Electronic data submission required to keep pace with growing ESRD population & need for current data


new rules require new interpretive guidance
New Rules Require New Interpretive Guidance

Interpretive Guidance (IG) is CMS’ interpretation of the Rule ; provides clarification to surveyors & providers

Community input was sought for this guidance

Read the final IG’s that were released Oct 4.


dietitian qualifications 494 140 c 2
Dietitian Qualifications494.140(c)(2)
  • Requires a dietitian “have a minimum of one year professional work experience in clinical nutrition as a registered dietitian.” Must meet licensure requirements in their state & have evidence of registration with CDR.
  • Experience as an intern prior to registration, or foodservice professional experience after registration does not count.
  • The one year of professional work experience in clinical nutrition is AFTER successful completion of the registration exam.
dietitian qualifications 494 140 c 28
Dietitian Qualifications494.140(c)(2)
  • A dietitian with less than one year of clinical experience cannot meet the patient assessment, plan of care, QAPI program review, or care at home requirements of the regulations.
  • Final IG’s: The facility may define other tasks for the dietitian with less than one year of experience in a clinical setting.
dietetic technicians
Dietetic Technicians
  • Final rule requires an RD to be a member of the dialysis facility IDT, perform patient assessments, and participate in patient care planning and the QAPI program.
  • The RD may use a DTR to provide assistance under RD supervision, but it is the RD who must meet these conditions of coverage. (p. 20422 Federal Register)
  • No defined staff to dialysis patient ratio, and defers to state provisions that may have implemented ratios.
  • CMS does state - “Dialysis dietitian caseloads must not prevent RDs from providing care consistent with national standards of practice for dietitians”.
adequate staff v758
Adequate StaffV758
  • “Dialysis facilities are required to have adequate staff available to meet the care needs of their dialysis patients.” Adequate staff is defined as “staffing sufficient so that quality care is provided to dialyisis patients that is consistent with the patient plan of care and professional practice standards.”
  • The registered nurse, social worker, and dietitian members of the interdisciplinary team are available to meet patient clinical needs.
adequate staff v75812
Adequate StaffV758
  • If a facility “shares” the social worker of dietitian with multiple clinics or requires professional staff to perform non-clinical tasks, it must NOT negatively impact the time available to provide the clinical interventions required to achieve the goals identified in the patient’s plan of care.
  • The facility CEO or administrator is responsible to assure the professional support staff members have sufficient time available in the facility to meet the clinical needs of in-center and home dialysis patients.
adequate staff v75813
Adequate StaffV758
  • This final rule requires that the IDT provide appropriate care to dialysis patients and improve patient care on an ongoing basis.
  • The dialysis facility may need to evaluate staffing levels as part of their action plan for the QAPI program.
condition patient assessment v500 494 80
Condition: Patient AssessmentV500 494.80
  • Addresses the requirements for an interdisciplinary assessment of patients needs.
  • The interdisciplinary team (IDT) consists of, at a minimum, the patient or patient’s designee, an RN, an MD treating the patient for ESRD, a social worker and an RD.
  • The IDT is responsible for providing each patient with an individualized and comprehensive assessment of his or her needs. The assessment must be used to develop the patient’s treatment plan and expectations for care.
condition patient assessment v500 494 8016
Condition: Patient AssessmentV500 494.80
  • “Individualized”: each assessment is unique to a particular patient and addresses that patient’s needs.”
  • “Comprehensive”: the assessment covers and addresses all issues that are actionable by the dialysis facility.”
  • Must include integration of the evaluations by each IDT member
  • “The assessment may be incorporated into one document or composed of sections developed by each team member.”
assessment criteria v502 515
Evaluation of current health status and medical condition, including co-morbid conditions

Evaluation of dialysis prescription

Blood pressure and fluid management

Laboratory profile

Immunization history and medication history

Factors associated with anemia

Factors associated with renal bone disease

Nutritional status (RD)

Psychosocial needs (MSW)

Access type and maintenance

Evaluation of patients abilities, interests, preferences, and goals, including the desired level of participation in the dialysis care process

Transplantation suitability

Evaluation of family and other support systems

Current physical activity level

Need for vocational and physical rehabilitation services

Assessment Criteria V502-515
minimum criteria for nutrition assessment
Minimum Criteria for Nutrition Assessment

Nutrition Assessment will include the following, but are not limited to:

  • Nutritional status
  • Hydration status
  • Metabolic parameters such as glycemic control (diabetics) and cardiovascular health
  • Anthropometrics & recent change
  • Appetite and intake
  • Ability to chew and swallow
  • Gastrointestinal issues
  • Use of prescribed and over-the-counter nutritional, dietary, or herbal supplements
  • Previous diets and/or nutrition education
  • Route of nutrition
  • Self-management skills
  • Attitude to nutrition, health, and well-being;
  • Motivation to make changes to meet nutrition and other health goals
minimum criteria for nutrition assessment19
Minimum Criteria for Nutrition Assessment
  • Information sources: the patient, the individual that cooks and provides meals for the patient.
  • Obtain the patient’s permission to conduct an interview with family or caregivers
  • If the patient is a resident of a LTC facility the RD should contact the staff as part of the assessment and to provide continuity of care.
minimum criteria for nutrition assessment20
Minimum Criteria for Nutrition Assessment

The evaluation of the patient’s nutritional status must be conducted by a qualified RD.

Other members of IDT may contribute to portions of CMPA correlating with the nutritional evaluation (ex: fluid management, co-morbid conditions, dialysis adequacy)

renal bone disease evaluation v508
  • Lab review: Ca, Phosphorus, PTH
  • Related medications (e.g. phosphate binders, vitamin D analogs, calcimimetic agents); include over-the-counter medications
  • Assessment of diet adherence and understanding of diet.
  • Evaluation of medical conditions that impact renal bone disease management
things to ask yourself
  • Does my current nutrition assessment cover the areas highlighted in the IG’s?
  • Yes  No changes required
  • No  Update assessment form
frequency of assessment v516
Frequency of AssessmentV516
  • Initial Multidisciplinary Comprehensive Assessment
    • Completed within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first outpatient dialysis session.
    • For all patients new to any outpatient facility without regard to modality
    • Patients returning to dialysis from a failed transplant or changing modalities are also considered “new” patients
transfer transient patient cmpa v516
Transfer/Transient Patient CMPAV516
  • “If the comprehensive patient assessment and plan of care for an experienced dialysis patient transferring from one dialysis facility to another is received with the patient in transfer, the receiving facility's IDT must conduct a reassessment within 3 months of the patient’s admission to the new facility.”
  • This provision also applies to transient patients received with an assessment and plan of care.
frequency of assessment
Frequency of Assessment
  • Follow up CMPA
    • Must occur within 3 months after the completion of the initial CMPA.
    • Re-evaluate: how well patients follow their treatment plan, their educational, rehabilitation, and nutritional needs, their adjustment to dialysis regimen.
    • Re-evaluate: accuracy and appropriateness of patients’ plan of care.
patient reassessment v519
Patient Reassessment V519
  • A CMPA and a revision of the plan of care must be conducted annually on stable patients.
  • First annual reassessment due 12 months after the 3 month reassessment or 15 months after the patient’s admission to the facility.
  • CMPA must demonstrate integration of the evaluations completed by each team member. May be incorporated into 1 document or composed of sections developed by each team member as long as specific criteria from V502-514 are included.
unstable patient criteria v520
  • Minimum of 4 criteria for classifying patients as unstable. The IDT, based on their professional judgement, may develop further criteria based upon their patient population and characteristics.
  • While one discipline may trigger an unstable status, all disciplines must review and document whether their area was changed by the unstable status or remained unchanged.
patient reassessment criteria v520
Patient Reassessment Criteria V520
  • Extended or frequent hospitalizations defined as admissions longer than 15 days or more than 3 hospitalizations in a month. The reason for the admission may also result in the patient being classified as “unstable”.
  • Marked deterioration in health status
    • Change in ambulation severe enough to interfere with the ability to follow aspects of the treatment plan
    • Hypotension, restlessness, pruritis or other symptoms severe enough to prevent completion of the majority of dialysis treatments
    • Sudden onset of recurrent cardiac arrhythmias
    • Recurrent infections
    • Chronic congestive heart failure with chronic hypotension
    • Advanced or metastatic cancer or other organ system disease which interferes with the patient’s ability to follow aspects of the treatment plan
    • Chronic or recurrent peritonitis
patient reassessment criteria v52029
Patient Reassessment Criteria V520
  • Significant change in psychosocial needs. Includes any event which interferes with the patients ability to follow aspects of their treatment plan.
  • Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis.

• Poor nutritional status would include failure to thrive symptoms, with loss of body weight and low serum albumin

    • Unmanaged anemia would include continued lab findings of hemoglobin/hematocrit values which are out of range
    • Inadequate dialsysis would include a trend of results for Kt/V or URR which do not meet minimum expectations. This would also include symptoms related to fluid management such as volume overload or depletion; intradialytic symptoms such as syncope or CHF; hypertension; or the need for extra treatment(s) for fluid removal.
patient reassessment criteria v52030
Patient Reassessment Criteria V520
  • Facilities must have a method for classifying patients as “unstable.”
  • Documentation should be available of a monthly re-assessment and plan of care revision that addresses the issues related to the classification of the unstable patient until the issue(s) have been resolved or the IDT determine that the condition is chronic and the active care plan addresses the issues.
what does the rd need to do
What Does the RD Need to Do?
  • Work with the other members of the IDT to set up an annual patient assessment schedule
  • Define unstable nutritional parameters and how you will track them
plan of care 494 90
Plan of Care §494.90

“The interdisciplinary team (IDT) must develop and implement a written, individualized comprehensive plan of care that…”

Specifies services needed to address patient needs identified by the comprehensive assessment

Changes in the patient’s condition

Includes measurable and expected outcomes

Includes an estimated timetable to achieve outcomes

Outcomes must be consistent with evidence-based practice standards

plan of care
Plan of Care
  • The plan of care is “built upon the patient assessment.”
  • The plan of care must be reviewed and revised after each patient assessment
  • The plan of care must be updated if the target goals are not achieved or sustained
  • It is expected that each individual patient will have a plan of care that is unique to his/her needs
  • Initially goals may be different than targets, and revised/changed “to the standard target value as the patient outcomes improve.”
plan of care35
Plan of Care
  • The patient needs to be recognized as a member of the IDT and be encouraged to participate in the development and revision of the plan of care.
  • Patient “needs, wishes, and goals must be considered” when establishing the plan of care.
plan of care36
Plan of Care
  • The plan of care must address:
    • Problem(s) identified during the assessment/reassessment process
    • Measurable goals and outcomes
    • Planned interventions for achieving goals
    • Timetables
    • Reassessment date(s)

This may be one document or multiple documents but must be “congruent and reflect the integration of the comprehensive assessment findings of all IDT members.

plan of care37
Plan of Care
  • At a minimum the plan of care must address:
    • Dose of dialysis (target weight, estimated dry weight, Kt/V or URR, patient understanding of adequacy through education)
    • Nutritional status
    • Mineral metabolism
    • Anemia
    • Vascular access
    • Psychosocial status
    • Modality
    • Rehabilitation status
plan of care38
Plan of Care
  • Nutritional Status

“The interdisciplinary team must provide the necessary care and counseling services to achieve and sustain an effective nutritional status. A patient’s albumin level and body weight must be measured at least monthly. Additional evidence-based professionally-accepted clinical nutrition indicators may be monitored, as appropriate.”

plan of care nutritional status
Plan of Care—Nutritional Status
  • Interpretive Guidance states:
    • There must be an established albumin target goal for the facility.
    • Weight trends need to be monitored.
    • Sodium, calcium, phosphorus, and potassium should be routinely monitored.
    • Other markers may be identified by the IDT.
    • Markers must reflect professionally-accepted clinical practice standards.
plan of care nutritional status40
Plan of Care-Nutritional Status
  • If the pt record shows a trend of problems in the patient’s nutritional status (ex: consistent low albumin, weight loss), the IDT must develop a plan of care.
  • “While it is not expected or required for facilities to provide nutritional supplements, the dietitian is expected to assist patients in achieving their nutritional goals by providing education, counseling and encouragement.”
plan of care mineral metabolism
Plan of Care- Mineral Metabolism
  • The facility is expected to have established target goals for patients’ calcium, phosphorus and PTH levels based on professionally-accepted clinical practice standards and CMS CPMs.
  • “Interventions for prevention and management of CKD mineral and bone disorder may include nutritional counseling, and the administration of medications (e.g., phosphate binders, vitamin D analogs, calcimimetic agents).”
  • In the event that a protocol/algorithm is used there needs to be evidence that the care for each patient is individualized.
plan of care42
Plan of Care
  • Mineral metabolism

“If the patient’s mineral metabolism goals are not being attained…the team should identify potential causes and address the barriers that may be preventing the patient from reaching the target values.”

This may include failure to take medications, failure to follow diet, lack of understanding, lack of resources to obtain appropriate foods and/or medications.

Patient education regarding their role in managing diet, medication and bone health is expected.

plan of care43
Plan of Care
  • “ The initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient HD sessions.”
  • The plan of care must be dated to indicate when it was initiated.
  • The plan of care must be completed within 15 days of the completion of the patients assessment (monthly or annual updates).
  • Monthly updates are required for unstable patients.
plan of care44
Plan of Care
  • If outcomes are not achieved then the IDT must revise the plan of care to achieve the desired goals. The team must-
    • Review/revise the plan of care to reflect the patient’s current condition;
    • Document the reasons why the patient was unable to achieve stated goals. Barriers to achievement of goals must be identified;
    • Implement plan of care change.
plan of care45
Plan of Care
  • “If the only reason documented for for failure to achieve goals(s) is patient non-compliance or non-adherence” the regulation requirement will not be met.
  • If this is the situation the IDT needs to identify potential causes of the non-adherence and address those causes.
  • The IDT must recognize the patient’s right to choose care that will “negatively impact his/her quality of live.”
plan of care46
Plan of Care
  • “These regulations require the IDT to demonstrate its members are ACTIVELY attempting to meet each patient’s plan of care goals. This Condition does not “require” a patient to meet every goal. Any member of the IDT, including the patient, may document why goals are not met or cannot be met.”
494 110 condition quality assessment and performance improvement qapi
494.110 Condition: Quality assessment and performance improvement (QAPI)
  • This is a new Condition that looks at facility cumulative data and requires facility-based assessment and improvement of care
  • Compliance is determined by:
    • review of clinical outcomes data
    • records of the facility QAPI
    • interviews of responsible staff including the medical director
  • Non-compliance may be warranted if a pattern of deficient practices could impact patient health and safety is identified. Examples include, but are not limited to:
    • absence of an effective QAPI program
    • failure to recognize major problems
    • failure to prioritize major problems
    • failure to take action to address identified problems
regulation 494 110 quality assessment and performance improvement
Regulation – 494.110 Quality assessment and performance improvement
  • The dialysis facility must develop, implement, maintain, and evaluate an effective, data-driven QAPI program with participation by the professional members of the IDT. The team must be lead by the medical director.
  • The IDT must communicate effectively and must devote sufficient time and attention to produce effective QAPI activities which positively influence their patient’s outcomes.
  • The QAPI program is expected to reflect the complexity of the dialysis facility’s organization and services and must focus on indicators related to improved health outcomes and the prevention and reduction of medical errors.
  • All services provided by the facility must be included (e.g. in-center, home hemodialysis, home peritoneal dialysis, reuse, central reprocessing, self-care).
regulation 494 110 quality assessment and performance improvement50
Regulation – 494.110 Quality assessment and performance improvement
  • The facility must maintain and demonstrate evidence of its QAPI for review by CMS. Records of activities must be available for review but do not need to be reported.
  • There must be an operationalized, written plan describing the QAPI program scope, objectives, organization, responsibilities of all participants, and procedures for overseeing the effectiveness of monitoring, assessing and problem-solving.
  • Data on current professionally-accepted clinical practice standards must be used to track health outcomes. ( See MAT) Efforts should be made to meet clinical practice guidelines or come as close as possible to meeting those guidelines for all patients.
  • Quality-oriented dialysis facilities that already have effective full-scale quality improvement programs will meet QAPI requirements
regulation 494 110 quality assessment and performance improvement51
Regulation – 494.110 Quality assessment and performance improvement
  • A facility whose treatment outcomes vary significantly from accepted standards must identify the reasons for poor outcomes and implement improvement projects to achieve expected outcomes
  • As the QAPI program is an internal facility function, facilities may use their own risk adjustors and include incident and/or prevalent patient designators within their programs. However, both adjusted and unadjusted QAPI data must be available for review but QAPI requires the use of aggregate patient data to evaluate the facility patient outcomes
  • It is recognized that patient adherence to the treatment plan can be a factor in meeting facility QAPI goals. It is possible that during prioritization of improvement activities that patient compliance trends need to be addressed within the QAPI program
  • CMS has not included minimum facility-level clinical standards. Setting thresholds below established performance levels could serve to undercut current performance levels. i.e currently 91% of HD patients achieve dialysis adequacy target and 81-84% of patients have a hemoglobin of >11.
regulation a standard program scope
Regulation – (a) Standard: Program scope
  • QAPI must include, but not be limited to:
    • an ongoing program which continuously looks at indicators as they are available, trends outcomes and develops an improvement plan when indicated
    • Achievement of measurable improvement in health outcomes and reduction of medical errors
    • Use of indicators or performance measures associated with improved health outcomes and with the identification and reduction of medical errors
  • The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations
regulation a standard program scope53
Regulation – (a) Standard: Program scope
  • Generally this would require at least monthly review of indicators, since prescribed patient indicators are typically evaluated with laboratory results monthly and this serves as a functional time frame for trending of data within the facility
  • Performance expectations are based on current professionally-accepted clinical practice standards. [Refer to the Measures Assessment Tool (MAT) which lists current professionally accepted and the CMS Clinical Performance Measures (CPMs)].
  • The facility must use broadly accepted, community developed standards (e.g., CMS CPMs, NKF KDOQI, AAMI) as performance measures.
  • Where minimum outcome values have been determined, facilities are expected to provide care directed at achievement of at least the minimum outcome value by all patients.
regulation ii nutritional status
Regulation – (ii) Nutritional status
  • Serum albumin is a valid and useful measure of protein-energy nutritional status in maintenance dialysis patients. Serum albumin levels are commonly and extensively used to evaluate the nutritional status of ESRD patients. Low albumin levels are highly predictive of mortality risk
  • Serum albumin is affected by inflammation and other factors as well as by diet. The IDT may not be able to have a majority of its patients achieve the desired goal for this area, but should be actively intervening on actionable factors

Measurements Assessment Tool (MAT)

  • Unspecified in Conditions for Coverage and CPMs. Refer to parameters in Patient assessment V509
  • Values – Increase % in target range
regulation iii mineral metabolism and renal bone disease
Regulation – (iii) Mineral metabolism and renal bone disease
  • Intent is to address management of mineral metabolism and renal bone disease is to maximize the number of patients who achieve the goals for this area
  • Since this area is heavily influenced by patient diet, it is critical that patient education, encouragement and support be included in improvement plans for this indicator
  • If the facility uses a standardized mineral metabolism protocol or algorithm, the efficacy of this tool must be evaluated if facility QAPI goals in this area are not achieved over consecutive evaluation periods

Measurement Assessment Tool (MAT)

  • Measure
    • Calcium, Phosphorus, PTH
  • Values
    • Increase % in target range monthly
additional qapi regulations
Vascular access

Anemia Management


Medical injuries and medical errors identification

Hemodialyzer reuse program (if reuse is used)

Patient satisfaction and grievances

Infection control


Patient (treatment options) education measured annually

Health outcomes: Physical and mental functioning

Health outcomes: Patient survival

Additional QAPI Regulations
  • Facilities are encouraged to include social services and other suggested QAPI topics when appropriate, but are not requiring additional topics.
  • It is expected that the facilities devote the needed resources to their QAPI programs, based on prioritization of facility needs
regulation b standard monitoring performance improvement
Regulation – (b) Standard: Monitoring performance improvement
  • The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time.
  • Outcome data, achievement of treatment goals, adverse events, infections, falls, errors, etc. must be monitored as this data is available or as these events occur. Tracking and trending, analysis of root causes, development of improvement plans, implementation of those plans, evaluation of the success of the plan, and revision of the plan must occur as indicated.
  • Once improvement is made, there must be a mechanism to ensure that improvement is sustained.
  • The medical director must communicate with the governing body about the status of QAPI activities and be demonstrated in the minutes.
other rd related mentions
Other RD Related Mentions
  • Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station.
    • Physicians and non-physician practitioners functioning in lieu of physicians (i.e., advanced practice registered nurses and physician assistants), social workers and dietitians must follow these same requirements for glove use and hand hygiene
other rd related mentions59
Other RD Related Mentions
  • Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory.
    • Physicians, advanced practice registered nurses, physician assistants, social workers and dietitians must wear a cover garmentwhich provides an impervious barrier to fluidsif they are providing service to any patient in the treatment area during a time of high risk for spurting or spattering of blood, as, for example, duringinitiation or termination of dialysis. The garment should be changed if it becomes soiled. Visitors must be provided impervious cover garments if they are in the treatment area during initiation or termination of dialysis
home dialysis patients
Home Dialysis Patients
  • Patient consultation with members of the interdisciplinary team, as needed.
    • The home dialysis patients must have access to members of the IDT (i.e. RN, RD, social worker, MD treating the patient, as defined at V501), who must be available to provide clinical services as needed by the patient. The IDT must include the staff member who is responsible for the coordination of that patient’s care.
    • Contact may be in-person, by phone, by mail or by email with confirmation of patient receipt. The required minimum frequency of contacts may be defined by facility policy, but must meet the individual needs of each patient in accordance with their plan of care.
    • Note the requirements at V510 for initial and periodic evaluation of all patients by a qualified social worker and at V509 for evaluation by a qualified RD.