Transcript Test Title Page Template

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
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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
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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
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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.
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RD & Dietetic Technician Qualifications
Dietitian Qualifications
494.140(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)(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
• 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)
Caseloads
• 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
• “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
V758
• 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
V758
• 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.
Comprehensive Multidisciplinary Patient
Assessment (CMPA)
Condition: Patient Assessment
V500 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 494.80
• “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
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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
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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
Minimum Criteria for Nutrition Assessment
Nutrition Assessment will include the following, but are not limited to:
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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 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 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
• 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
• “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
• 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
• 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
1.
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”.
2.
Marked deterioration in health status
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Change in ambulation severe enough to interfere with the ability
to follow aspects of the treatment plan
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Hypotension, restlessness, pruritis or other symptoms severe
enough to prevent completion of the majority of dialysis
treatments
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Sudden onset of recurrent cardiac arrhythmias
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Recurrent infections
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Chronic congestive heart failure with chronic hypotension
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Advanced or metastatic cancer or other organ system disease
which interferes with the patient’s ability to follow aspects of the
treatment plan
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Chronic or recurrent peritonitis
Patient Reassessment Criteria V520
3.
Significant change in psychosocial needs. Includes any
event which interferes with the patients ability to follow
aspects of their treatment plan.
4.
Concurrent poor nutritional status, unmanaged anemia and
inadequate dialysis.
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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 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?
• 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
Patient Plan of Care
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
• 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 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 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 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 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 evidencebased professionally-accepted clinical nutrition
indicators may be monitored, as appropriate.”
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 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
• 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 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 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 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 Care
• “If the only reason documented for for failure to
achieve goals(s) is patient non-compliance or nonadherence” 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 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.”
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
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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.
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The IDT must communicate effectively and must devote sufficient time and
attention to produce effective QAPI activities which positively influence their
patient’s outcomes.
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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.
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All services provided by the facility must be included (e.g. in-center, home
hemodialysis, home peritoneal dialysis, reuse, central reprocessing, selfcare).
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 fullscale quality improvement programs will meet QAPI requirements
Regulation – 494.110 Quality assessment and performance
improvement
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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
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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
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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
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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
• 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 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 professionallyaccepted 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
• 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
• 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
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Vascular access
Anemia Management
Adequacy
Medical injuries and medical
errors identification
• Hemodialyzer reuse program (if
reuse is used)
• Patient satisfaction and
grievances
• Infection control
• Vaccinations
• Patient (treatment options)
education measured annually
• Health outcomes: Physical
and mental functioning
• Health outcomes: Patient
survival
•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
• 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
• 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 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 garment
which provides an impervious barrier to fluids if 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, during
initiation 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
• 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.
THANK YOU!
QUESTIONS?