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Demystifying the New Regulations: A User’s Guide to the Conditions for Coverage. Jan Deane, RN, CNN Network 11 Annual Meeting October 3, 2008. With a Special Thanks…. To Glenda Payne and Judith Kari for their assistance in putting this presentation together. Disclaimer.

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Demystifying the new regulations a user s guide to the conditions for coverage

Demystifying the New Regulations: A User’s Guide to the Conditions for Coverage

Jan Deane, RN, CNN

Network 11 Annual Meeting

October 3, 2008


With a special thanks
With a Special Thanks… Conditions for Coverage

To Glenda Payne and Judith Kari for their assistance in putting this presentation together.


Disclaimer
Disclaimer Conditions for Coverage

Although this presentation has been reviewed by CMS, it does not substitute for facility’s responsibility to become familiar with all the regulations and make all necessary changes to be in compliance with the new regulations by October 14, 2008.


Chronic hemodialysis
Chronic Hemodialysis Conditions for Coverage

  • First successful patient in 1960

  • Home hemodialysis became popular due to the high cost of treatment

  • Patient selection became an important part of the process

  • “Who shall receive care

    when not all can

    receive care?”


Medicare coverage for dialysis
Medicare Coverage for Dialysis Conditions for Coverage

  • Public Law 92-603, Section 2991

  • Dialysis and transplant would be covered under the Medicare program regardless of age

  • Dialysis became available for anyone

    …Then in 1976…


The long journey began
The Long Journey Began Conditions for Coverage


The esrd regulation timeline
The ESRD Regulation Timeline Conditions for Coverage

  • 1976: First ESRD regulations published

  • 70’s-90’s: Technical updates

  • 1994: Community Forum Meeting to begin complete rewrite of ESRD regulations

  • 2008: New ESRD regulations published

4


1994 community forum outcome
1994 Community Forum: Outcome Conditions for Coverage

From

To

First: Patient safety

Water

Reuse

Infection Control

Physical Environment

Change in Regulatory Focus

  • First: Paper reviews


1994 change in the survey process
1994: Change in the Survey Process Conditions for Coverage


1994 change in the survey process1
1994: Change in the Survey Process Conditions for Coverage


Common themes on the long journey
Common Themes on the Conditions for CoverageLong Journey

CMS & Kidney Community partnership

Survey process is driven by outcomes & data, not structure & paper

Striving for consistency & common understandings


Rationale behind the changes

Rationale Behind the Changes Conditions for Coverage


Rationale for esrd regulation changes
Rationale for ESRD Regulation Changes Conditions for Coverage

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

Necessary if CMS moves to bundled reimbursement for ESRD care


Reasons for change
Reasons for Change Conditions for Coverage

Changes in technology

Water treatment: more complex

Changes in dialysis equipment

Differences in care delivery

1970’s: few technicians; regulations are silent

2008: technicians provide most direct care; public is demanding regulation


Reasons for changes
Reasons for Changes Conditions for Coverage

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

RPA’s Adequacy of Dialysis Report

K/DOQI Guidelines

Fistula First Breakthrough Initiative

QAPI: accepted process of quality assessment across provider types

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


Introducing the new conditions for coverage october 14 2008 so what s new
Introducing the new Conditions for Coverage Conditions for CoverageOctober 14, 2008So what’s new??


Subpart a general provisions
Subpart A: General Provisions Conditions for Coverage


Subpart b patient safety
Subpart B: Conditions for CoveragePatient Safety


494 30 infection control
494.30: Infection Control Conditions for Coverage

  • Official adoption of the CDC Guidelines

    • “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients” MMWR 4/27/2001

  • More focus – Condition level importance

  • Moved higher in the survey process

  • PPE Changes – GOWNS not APRONS!


494 30 infection control1
494.30: Infection Control Conditions for Coverage

  • Isolation rooms for HBV infected patients

    • All new facilities built after 2/9/2009

    • Older facilities may use a separated area

  • Infection control issues

    • Medical director involvement

    • QI process

      • Develop tracking process

      • Use comprehensive QI process to understand


494 40 water and dialysate quality
494.40: Water and Dialysate Quality Conditions for Coverage

  • Meet AAMI standards for water and dialysate purity

    • “Dialysate for Hemodialysis” ANSI/AAMI RD52:2004

  • Increased frequency of chlorine/chloramine testing

  • Quality assurance plan for adverse occurrences that assures patient safety


494 50 reuse of hemodialyzers and bloodlines
494.50: Reuse of Hemodialyzers and Bloodlines Conditions for Coverage

  • No reuse for HBV patients

  • Adherence to AAMI Guidelines

    • “Reuse of Hemodialyzers” ANSI/AAMI RD47:2002

  • Expanded quality assurance processes including suspending reuse in the presence of clusters of adverse patient reactions


494 60 physical environment
494.60: Physical Environment Conditions for Coverage

  • Patient care environment

    • Comfortable temperature

    • Patient privacy

    • Patients within view of care staff including vascular access and line connections


494 60 physical environment1
494.60: Physical Environment Conditions for Coverage

  • Emergency Preparedness

    • Staff training

      • Medical emergencies – CPR certification

      • Non-medical emergencies including weather related emergencies

      • Emergency equipment

      • Patient Education

      • Disconnect procedure

      • Where to go in the event of an emergency


494 60 physical environment2
494.60: Physical Environment Conditions for Coverage

  • Emergency Preparedness

    • Equipment

      • Oxygen, airways, suction

      • Defibrillator or Automatic External Defibrillator

    • Exemption for hospital based units with access to hospital resuscitation team if response is within a timely manner (4-5 minutes)


494 60 physical environment3
494.60: Physical Environment Conditions for Coverage

  • Fire Safety

    • Compliance with the applicable sections of the 2000 Life Safety Code (National Fire Protection Association)

    • Exemption to sprinklered sectionif facility was built before 1/1/2006 and state law permits

    • Must follow State law if State law is more strict than the LSC provisions.


Subpart c patient care
Subpart C: Patient Care Conditions for Coverage


494 70 patient rights
494.70: Patient Rights Conditions for Coverage

  • Not a lot of changes but mostly expansion and clarification of existing patient rights

  • Addition of several new patient rights

    • Advance Care Planning discussions

    • Information regarding all treatment modalities and including scheduling options

    • Grievances – expanded to 3 tags


494 70 patient rights1
494.70: Patient Rights Conditions for Coverage

  • Involuntary Discharge

    • Included in Patient Rights Condition as well as patient assessment and governance

    • Under this Condition, specifically information regarding the facility policy for involuntary discharge AND the right to written 30 day notice


494 80 patient assessment
494.80: Patient Assessment Conditions for Coverage

  • Interdisciplinary team involvement – at a minimum

    • Patient or patient’s designee

    • Registered nurse

    • Patient’s nephrologist

    • Social worker

    • Dietitian


494 80 patient assessment1
494.80: Patient Assessment Conditions for Coverage

  • Comprehensive initial assessment

    • All new patients within 30 days or 13 treatments

  • Follow-up comprehensive reassessment

    • All new patients within 3 months following the initial assessment

  • Additional reassessments

    • Stable patients – annually thereafter

    • Unstable patients – monthly until stable


494 80 patient assessment2
494.80: Patient Assessment Conditions for Coverage

  • What is an unstable patient?

    • Extended or frequent hospitalizations

    • Marked deterioration in in health status

    • Significant change in psychosocial needs

    • Concurrent poor nutritional status, unmanaged anemia, and inadequate dialysis

      Facilities need to have a method of classifying patients


494 80 patient assessment3
494.80: Patient Assessment Conditions for Coverage

  • Current health status

  • Appropriateness of dialysis prescription

  • BP and fluid management

  • Laboratory tests

  • Immunization and medications

  • Family and support

  • Physical activity

  • Anemia management

  • Renal bone disease

  • Nutritional status

  • Psychosocial needs

  • Dialysis access

  • Patient’s desired level of participation in care

  • Suitability for transplant


494 80 physical assessment
494.80: Physical Assessment Conditions for Coverage

  • Caveats

    • Emphasis is on TEAM – everyone working together – patient included

    • Interdisciplinary is different from multidisciplinary: more collaborative, more congruent

    • Policies and procedures are fine – they need to be operationalized.

    • Breakout session this afternoon will look at ways in which providers are making this work in real life.


494 90 patient plan of care
494.90: Patient Plan of Care Conditions for Coverage

  • Interdisciplinary team involvement – at a minimum:

    • Patient or patient’s designee

    • Registered nurse

    • Patient’s nephrologist

    • Social worker

    • Dietitian

    • Be signed by all team members, including the patient or designee


494 90 patient plan of care1
494.90: Patient Plan of Care Conditions for Coverage

  • Implementation must begin within 30 days or 13 treatment of initiation of dialysis

  • Implementation of monthly or annual updates to the plan must be performed within 15 days of the completion of additional assessments or reassessment.


494 90 patient plan of care2
494.90: Patient Plan of Care Conditions for Coverage

  • Dose of dialysis

  • Meet and sustain Kt/V of 1.2 (HD) or 1.7 (PD)

  • Nutritional status

  • Mineral metabolism

  • Anemia

  • Home assessment for home patients

  • Response to ESAs

  • Vascular access type

  • Vascular access monitoring

  • Psychosocial status

  • Modality

  • Transplant status

  • Rehab status


494 90 patient plan of care3
494.90: Patient Plan of Care Conditions for Coverage

  • What QOL tool is recommended?

    • CPM to be implemented in 2009 calls for KDQOL

    • The CrownWeb system will require KDQOL domains to be entered.

    • So…


494 90 patient plan of care4
494.90: Patient Plan of Care Conditions for Coverage

  • Additional points to remember

    • If expected outcome for any areais not achieved and sustained

      • Documentation of revision for that portion of the POC and QI process

    • Nephrologist visits requiredmonthly

      • Can be Advanced practice RN or physician assistant

    • Transplant referral tracking

      • Workup process

      • Waitlist tracking


494 90 patient care planning
494.90: Patient Care Planning Conditions for Coverage

  • Patient education

    • Dialysis experience

    • Dialysis management

    • Infection control

    • Home dialysis and self dialysis

    • Quality of life, rehabilitation

    • Transplantation

    • Vascular access


494 100 care at home
494.100: Care at Home Conditions for Coverage

  • New as a Condition

  • Home dialysis services must be at least equal to that provided for in-center patients

  • Interdisciplinary team oversees training

  • Be conducted by a registered nurse who meets qualifications

  • Specific areas to be covered in the training


494 100 care at home1
494.100: Care at Home Conditions for Coverage

  • Periodic monitoring of home adaptation including home visits

  • Assessment and care planning same as for in-center patients

  • Meet specific water and dialysate testing requirements – refer to conditions for specifics

  • Planning for back-up services


494 110 quality assessment and performance improvement
494.110: Quality Assessment and Performance Improvement Conditions for Coverage

“The facility must develop, implement, maintain, and evaluate an effective, data driven, quality assessment and performance improvement program with participation by the professional members of the interdisciplinary team.”


494 110 quality assessment and performance improvement1
494.110: Quality Assessment and Performance Improvement Conditions for Coverage

  • Facility-wide – all services must be included

    • In-center hemodialysis

    • Home hemodialysis

    • Peritoneal dialysis

    • Reprocessing

    • Water quality

      …Just to mention a few…


494 110 quality assessment and performance improvement2
494.110: Quality Assessment and Performance Improvement Conditions for Coverage

  • Use of professionally accepted clinical practice guidelines to track health outcomes

  • Identification, prevention, and reduction of medical errors

  • Action towards improving outcomes not meeting target levels

  • Patient satisfaction is included – CAHPS tool is recommended by CMS


494 110 quality assessment and performance improvement3
494.110: Quality Assessment and Performance Improvement Conditions for Coverage

  • Use of principles of CQI

    • Monitor data/information

    • Prioritize areas for improvement

    • Determining potential root causes

    • Developing, implementing, evaluating, and revising plans that will result in improvements in care


494 110 quality assessment and performance improvement4

Adequacy of dialysis Conditions for Coverage

Nutritional status

Bone and mineral metabolism

Anemia management

Vascular access

Medical errors

Hemodialyzer reuse

Patient satisfaction and grievances

Infection control including surveillance and immunization status

494.110: Quality Assessment and Performance Improvement


Measures assessment tool
Measures Assessment Tool Conditions for Coverage


Subpart d administration
Subpart D Conditions for CoverageAdministration


494 140 personnel qualifications
494.140: Personnel Qualifications Conditions for Coverage

  • Registered nurse

    • Nurse manager

      • RN, full time, 12 months nursing + 6 months dialysis

    • Home training nurse

      • RN, 12 months nursing + 3 months in home therapy

    • Charge nurse

      • RN, LPN/LVN, 12 months nursing including 3 months dialysis

    • Staff nurse

      • RN, LPN/LVN


494 140 personnel qualifications1
494.140: Personnel Qualifications Conditions for Coverage

  • Dietitian

    • Must now have 1 year experience clinical experience AFTER registration

  • Social Worker

    • Has not changed but there are more specific directions as to the educational preparation

    • Council of Social Work Education

      www. cswe.org


494 140 personnel qualifications2
494.140: Personnel Qualifications Conditions for Coverage

  • Patient Care Technicians

    • High school diploma

    • Completed formal training program

      • Facility-based or college based

    • Obtain certification

      • National approved program (there are 3)

      • State certification programs if

        • Curricula meets regs

        • Standardized test

        • Proctored exam not given by dialysis facility


Patient care technicians
Patient Care Technicians Conditions for Coverage

  • Formalized training program

    • Written program

    • Approved by medical director

    • Under the direction of a registered nurse

    • Meets specific components of the dialysis procedure and patient care

    • Demonstrated competency

      • Written exam

      • Skills validation


Patient care technicians1
Patient Care Technicians Conditions for Coverage

  • National certification

    • Current PCTs – by 4/15/2010

    • Newly hired PCTs after 10/14/2008 – 18 months after hire date

    • Nationally accepted program

      • Nephrology Nursing Certification Commission

      • Board of Nephrology Examiners for Nursing and Technology

      • National Nephrology Certification Organization


Patient care technicians2
Patient Care Technicians Conditions for Coverage

  • FAQs:

    • PCTs with > 4 years experience with NO high school diploma may use work experience in lieu of diploma

    • Non-certified PCTs must complete formal training program before independently providing care

    • PCTs with > 2years experience as of 10/14/08 do not need to go through formalized training BUT must demonstrate competency with test and skills validation


494 150 medical director responsibilities
494.150: Medical Director Responsibilities Conditions for Coverage

  • Medical Director is specifically responsible for the following:

    • Quality assessment and performance improvement program

    • Staff education, training, and performance

    • Policies and procedures

      • All P/P related to patient care are adhered to

      • Interdisciplinary team adheres to discharge/transfer policies and procedures – including involuntary discharge


494 180 governance
494.180: Governance Conditions for Coverage

  • CEO/Administrator is responsible for

    • Staff appointments

    • Relationship with the ESRD Network

      • Pursuing the goals and objectives of the Network – including the electronic submission of data – Crown Web

    • Allocation of staff resources for QAPI program

    • Adequate staffing

    • An RN is present in the facility at all times when patients are being treated


494 180 governance1
494.180: Governance Conditions for Coverage

  • Internal Grievance Process

    • Also addressed under Patient Rights

    • Clearly defined procedure including time frames

    • Processes for communicating with the patient

    • Those complaints or grievances that involve patient safety must be addressed immediately


494 180 governance2
494.180: Governance Conditions for Coverage

  • Involuntary Discharge

    • The medical director assures that no patient is discharged or transferred from the facility except for the following reasons:

      • Failure to pay for ordered services

      • The facility ceases to operate

      • The transfer is necessary for the patient’s welfare because the facility can no longer meet the patient’s documented medical needs

        OR


Involuntary discharge
Involuntary Discharge Conditions for Coverage

  • The facility has reassessed the patient and determined that the patient’s behavior is disruptive and abusive to the extent that the delivery of care to the patient or the ability of the facility to operate effectively is seriously impaired.


Involuntary discharge1
Involuntary Discharge Conditions for Coverage

  • The Medical Director ensures that the interdisciplinary team

    • Documents the reassessment and on-going problems

    • Provides the patient and ESRD Network with 30 day notice

    • Obtains a written order from patient’s physician and the medical director


Involuntary discharge2
Involuntary Discharge Conditions for Coverage

4. Makes contact with at least one other facility and attempts to place the patient there

5. Notifies the State Survey Agency of the discharge

And…

Document, Document, Document


Involuntary discharge3
Involuntary Discharge Conditions for Coverage

  • In the event of immediate severe threats to the health and safety of others, the facility may use an abbreviated involuntary discharge procedure

    • Threat of physical harm

    • Calling 911 or otherwise seeking police involvement

    • After emergency is addressed, medical director and patient physician are notified as well as Network and State Agency


Involuntary discharge4
Involuntary Discharge Conditions for Coverage

  • Interpretive Guidelines strongly suggest the use of the Decreasing Dialysis Patient Provider (DPC) tools to proactively address conflict in the dialysis facility.


494 180 governance3
494.180 Governance Conditions for Coverage

  • Electronic forms submission for the ESRD program administration

    • Working with ESRD Networks in the Crown Web process

      • February 1, 2009 process will begin for ESRD forms

      • 2728 Medical Evidence Form

      • 2746 Death form

      • Clinical Performance Measures

      • Cost report and Administrative data


494 180 governance4
494.180: Governance Conditions for Coverage

  • Relationship with the ESRD Network

    • Improve the quality and safety of dialysis related services

    • Improve independence, quality of life, and rehabilitation through encouragement of transplant, self care dialysis, and home dialysis therapies

    • Encourage and support collaborative activities to achieve goals through the most efficient and effective means possible

    • Improve collection, reliability, timeliness of data to measure processes of care, maintain the patient registry, and support the ESRD Network program


Implementation of the conditions moving from paper to practice
Implementation of the Conditions: Conditions for CoverageMoving from paper to practice


Where do i start
Where Do I Start? Conditions for Coverage

  • Get to know your regulations

    • What is new and will have an effect on the day-to-day operation on the dialysis unit?

  • Ask the questions

    • How do we put this into practice?

    • What changes need to be made?

  • Develop the policy/procedure

  • Put it into practice!


How am i going to get everything done
How am I going to get everything done? Conditions for Coverage

  • Creative thinking

    • What is the best way to make this work?

  • Ground up – Bottom down

    • Supportive leadership

    • The best ideas come from those who are closest to the work

  • Use the team

    • Delegate, delegate, delegate!


The goal is
The Goal is… Conditions for Coverage

  • Safe

  • Effective

  • Patient Centered

  • Timely

  • Equitable

  • Efficient

  • The Right care for every patient every time


Important links
Important Links Conditions for Coverage

  • Conditions

    http://www.cms.hhs.gov/CFCsAndCoPs/13_ESRD.asp#TopOfPage

  • Interpretive Guidelines

    http://www.cms.hhs.gov/SurveyCertificationGenInfo/downloads/SCletter08-31.pdf

  • ANNA/NKF Comprehensive Assessment Form

    http://www.annanurse.org/download/reference/health/cmpa.pdf



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