Demystifying the New Regulations: A User’s Guide to the Conditions for Coverage Jan Deane, RN, CNN...

Demystifying the New Regulations: A User’s Guide to

the Conditions for Coverage

Jan Deane, RN, CNNNetwork 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

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

• 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

• 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 ESRD Regulation Timeline

• 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

From• First: Paper reviews

To• First: Patient safety

– Water– Reuse– Infection Control– Physical Environment

Change in Regulatory Focus

1994: Change in the Survey Process

From a focus on: To a focus on:

• Policies

• Procedures

• Personnel records

• Reviewing data

• Observing care

• Interviewing patients• Interviewing the

people doing the work

1994: Change in the Survey Process

From a focus on: To a focus on:Structure Outcomes

• Practices: water treatment results, dialysis adequacy

• Data: Dialysis Facility Reports

• Community-set minimum standards

Common Themes on the Long 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 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• Necessary if CMS moves to bundled

reimbursement for ESRD care

Reasons for Change

• 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

• 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??

Subpart A: General Provisions

Subpart B:Patient Safety

494.30: Infection Control

• 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 Control

• 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

• 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

• 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

• Patient care environment– Comfortable temperature– Patient privacy– Patients within view of care staff including

vascular access and line connections


• 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


• 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)


• Fire Safety– Compliance with the applicable sections of the

2000 Life Safety Code (National Fire Protection Association)

– Exemption to sprinklered section if 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

494.70: Patient Rights

• 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 Rights

• 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

• Interdisciplinary team involvement – at a minimum– Patient or patient’s designee– Registered nurse– Patient’s nephrologist– Social worker– Dietitian

494.80: Patient Assessment• 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 Assessment

• 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 dialysisFacilities need to have a method of classifying patients

494.80: Patient Assessment- 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• 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• 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 Care

• 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.


• 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


• 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 Care• Additional points to remember

– If expected outcome for any area is not achieved and sustained

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

– Nephrologist visits required monthly• Can be Advanced practice RN or physician assistant

– Transplant referral tracking• Workup process• Waitlist tracking

494.90: Patient Care Planning

• 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

• 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 Home

• 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

“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.”


• Facility-wide – all services must be included– In-center hemodialysis– Home hemodialysis– Peritoneal dialysis– Reprocessing– Water quality…Just to mention a few…


• 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


• 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


• Adequacy of dialysis• 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

Measures Assessment Tool

Subpart DAdministration

494.140: Personnel Qualifications• 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 Qualifications

• 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 Educationwww. cswe.org

494.140: Personnel Qualifications

• 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

• 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 Technicians

• 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 Technicians• 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

• 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• 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: Governance

• 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: Governance• 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

• 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.


• The Medical Director ensures that the interdisciplinary team1. Documents the reassessment and on-going

problems2. Provides the patient and ESRD Network with

30 day notice3. Obtains a written order from patient’s

physician and the medical director


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 Discharge• 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


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

494.180 Governance• 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: Governance• 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

Where Do I Start?• 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?

• 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…

• Safe• Effective• Patient Centered• Timely• Equitable• Efficient

• The Right care for every patient every time

Important Links

• Conditionshttp://www.cms.hhs.gov/CFCsAndCoPs/13_ESRD.asp#TopOfPage • Interpretive Guidelineshttp://www.cms.hhs.gov/SurveyCertificationGenInfo/downloads/SCletter08-31.pdf

• ANNA/NKF Comprehensive Assessment Formhttp://www.annanurse.org/download/reference/health/cmpa.pdf

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










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










Thank you!!

Questions?

[email protected]

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