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It’s 2007! Mandatory Accreditation is Here! Are You Prepared? Wednesday, April 25, 2007 MedTrade Spring. Mary Ellen Conway President. Overview. What is the accreditation requirement? Who are the recognized accreditation providers? When do YOU need to be ready? First 10 MSA’s, Next 80

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it s 2007 mandatory accreditation is here are you prepared wednesday april 25 2007 medtrade spring

It’s 2007! Mandatory Accreditation is Here!Are You Prepared?Wednesday, April 25, 2007MedTrade Spring

Mary Ellen Conway


  • What is the accreditation requirement?
  • Who are the recognized accreditation providers?
  • When do YOU need to be ready?
  • First 10 MSA’s, Next 80
  • First Ten Products for Bidding
  • Final Quality Standards
  • Inconspicuous Items”
  • Concerns
overview continued
Overview Continued
  • Clarifications
  • Every Organization’s “Must Haves”
  • Accreditation choices- tips to use in your selection
  • How do you get started?
  • Review of the Final Quality Standards
  • Review of the recognized Accreditation Providers
  • Ten things you can do now to be ready
what is the accreditation requirement
What is the Accreditation Requirement?
  • The Medicare Modernization Act of 2003 (MMA ’03) states that ALL DME Providers billing Medicare for identified Part B products must be accredited by 2007--- this will be enforced initially through the Competitive Bidding Requirement
  • January 26 announcement rescinded BUT TODAY???
the dominos
The “Dominos”
  • CMS is enforcing the law that requires competitive bidding in 2007

(Now April 2008)

  • Only accredited organizations can submit a bid and “compete” in the bidding process
  • Accreditation must be by “recognized” accreditors
  • Provider must comply with Final Quality Standards (Released 8-14-06)
who are the recognized accreditors and then there were ten
Who Are the Recognized Accreditors?…And then there were ten…

Changed January 2007

JCAHO NB of A for Orthotic Suppliers




ABC of O&P The Compliance Team

when does competitive bidding begin and where
When Does Competitive Bidding Begin and Where?
  • Competitive bidding “rolls out” in 2007 in 10 Metropolitan Statistical Areas (MSA’s) and in 80 in 2009
    • Excludes New York, Chicago and Los Angeles in 2007
  • Only accredited providers can participate in competitive bidding
the first 10 msa s temporarily listed on cms website at 9 00 am 3 30 07
The First 10 MSA’sTemporarily Listed on CMS Websiteat 9:00 AM 3/30/07

Charlotte-Gastonia-Concord: NC-SC

Cincinnati-Middletown, OH-KY-IN

Cleveland-Elyria-Mentor, OH

Dallas-FT Worth-Arlington, TX

Kansas City, KS-MO

Miami, Ft Lauderdale, Miami Beach, FL

Riverside, San Bernadino, Ontario, CA

Orlando, Kissimmee, FL

Pittsburgh, PA

San Juan, Caguas, Guaynabo, Puerto Rico

the top 20 msa s were
The Top 20 MSA’s Were

Charlotte Boston

Miami Kansas City, MO and KS

Riverside, CA Pittsburgh

Phoenix San Francisco

Cincinnati Atlanta

Houston San Juan

Dallas St. Louis

Orlando Detroit

Tampa Seattle

Cleveland Philadelphia

next 80 largest msa s
Next 80 Largest MSA’s

Los Angeles New York Chicago San Diego

Washington, DC St Louis, MO/IL Richmond, VA Louisville

Nassua/Suffolk Oakland, CA Denver Newark, NJ

Portland, OR Ft Worth, TX Las Vegas San Jose, CA

Ft Lauderdale Indianapolis San Antonio Virginia Beach

Columbus, OH Milwaukee Bergen, NJ New Orleans

Salk Lake City Greensboro, NC Austin Nashville

Providence. RI Raleigh/Durham Hartford Buffalo

Middlesex/Somerset Memphis W Palm/Boca Monmouth

Jacksonville Rochester, NY Grand Rapids Fresno

next 80 largest msa s con t
Next 80 Largest MSA’s Con’t

Oklahoma City Greenville, SC Dayton, OHHonolulu

Albany Tucson Tulsa Ventura, CA

Syracuse Omaha Albuquerque Akron

Knoxville El Paso Bakersfield Gary, IN

Allentown, PA Harrisburg Scranton Toledo, OH

Jersey City Baton Rouge Youngstown, OH Springfield, MA

Little Rock Ann Arbor Stockton, CA Wichita

Charleston New Haven, CT Mobile, AL Columbia, SC

McAllen/Edinburg, TX Sarasota/Bradenton

in order to bid in the first round
In order to bid in the first round
  • You must be accredited by August 31st!
  • Means:
    • Survey scheduled by early- mid July
    • Work through all process through May/June


the msa

Uses US Census Data

  • Applies to defined Zip Codes where the beneficiary resides, not where the provider is located
  • Was excluding Mail Order in the First Round, but now includes only diabetic supplies via mail order
when do you need to be ready
When Do You Need to Be Ready?
  • If you provide any of the identified products or services to Medicare beneficiaries in any of the first 10 defined areas and wish to continue, you will be required to bid.
  • In order to bid, you will need to be accredited.
  • If you provide products and services to Medicare beneficiaries in such areas as who are NOT in the first defined service areas, you may be required to participate in Competitive Bidding in 2009 (80 MSA’s identified for Competitive Bidding in 2009)
  • All mail order starts in 2009 in the First 10 MSA’s and the subsequent 70.
  • All others are required to be accredited (whether or not there is Competitive Bidding in your service area) as early as 2009-2010—TODAY”S ANNOUNCEMENT
what if you provide products and services in rural areas only
What if You Provide Products and Services in Rural Areas Only?
  • You may never have to participate in Competitive Bidding
  • You will get a rate adjustment as CMS will begin to reimburse providers the rates paid in the closest MSA’s
  • You must be accredited by some date- no finite date released yet.
    • CMS advisory released Friday, January 26 (CR 5415 Transmittal 188) rescinded
current legislative activity
Current Legislative Activity
  • Tanner Hobson (formerly Hobson Tanner)

www.aahomecare.orgAdvocacy Updates

Also: Price Repeal of 36 mo Oxygen Cap (H.R. 621)

Final Product Categories
  • Oxygen Supplies and Equipment
  • Standard Power Wheelchairs, Scooters and Related Accessories
  • Complex Rehab Power Chairs and Related Accessories
  • Mail Order Diabetic Supplies
  • Enteral Nutrients, Equipment and Supplies
  • CPAP, RAD’s and Related Supplies and Accessories
  • Hospital Beds and Related Accessories
  • Negative Pressure Wound Therapy Pumps and Related Supplies and Accessories
  • Walkers and Related Accessories
  • Support Surfaces (Groups 2 and 3 mattresses and overlays) in Miami and San Juan only
product selection
Product Selection
  • CMS selected products for CB based on:
    • High cost
    • High-volume
    • Greatest potential for savings
final quality standards
Final Quality Standards
  • Were released on 8-14-06 !!!
  • 14 pages—as compared to 104 in September 2005
  • VERY MINIMAL compared to proposed standards- but don’t be fooled!

Found on the CMS website at: (http://www.)

  • Compliance with these standards will be enforced through the accreditation provider you select
final supplier quality standards
Final Supplier Quality Standards

2 Sections

First Section: Business Services

  • Administration
  • Financial Management
  • Human Resource Management
  • Consumer Services
  • Performance Management
  • Product Safety
  • Information Management
final supplier quality standards21
Final Supplier Quality Standards

Second Section: General Product Specific Service Standards

  • Preparation
    • Intake
    • Beneficiary Record
  • Delivery and Set-Up
  • Training/Instruction to Beneficiary and Caregiver
  • Follow-up
final supplier quality standards22
Final Supplier Quality Standards

Appendix A- C

A: Respiratory Equipment, Supplies and Services

  • Oxygen concentrators, reservoirs, high pressure cylinders, oxygen accessories and supplies, oxygen conserving devices
  • Home invasive mechanical ventilators
  • CPAP Devices
  • Respiratory Assist Devices
  • IPPPB Devices
  • Nebulizers
final supplier quality standards23
Final Supplier Quality Standards

Appendix A- C

B: Manual Wheelchairs, Power Mobility Devices, Complex Rehab and Assistive Technology

Key Issues in Complex Rehab and Assistive Technology:

  • Check items listed
  • Employ at least one qualified RTS per location
  • Provide appropriate equipment for trial
  • Provide private, clean and safe rooms appropriate for fitting and evaluation
  • Maintain a repair shop located in the facility
final supplier quality standards24
Final Supplier Quality Standards

Appendix A- C

C: Custom Fabricated, Custom Fitted, Custom-made Orthotics, Prosthetic Devices, Somatic, Ocular and Facial Prosthetics and Therapeutic Shoes and Inserts

  • Not off-the-shelf items
final standards
Final Standards


1. Obtains and supplies appropriate quality equipment, items and services

2. Have a physical location and display all licenses, certificates and permits

3. FDA approved items and obtain copies of features, warranties and instructions

4. Comply with Medicare policies (coverage, claims processing, payment policies and disclosure of ownership) Example:

Disbarment List

5. Implement business practices to prevent and control fraud, waste and abuse

6. Use procedures that articulate standards of conduct that ensure compliance with appl. laws and regs.

7. Designate leader(s) responsible for compliance issues

final standards26
Final Standards

Financial Management

1. Implement financial management practices that ensure accurate accounting and billing.

2. Accurate, complete and current financial records

3. Cash or accrual based accounting

4. Link equipment to client

5. Manage revenues and expenses on an ongoing basis:

  • Reconcile charges with invoices, receipts and deposits
  • Operating budget
  • Mechanism to track actual revenues and expenses
final standards27
Final Standards

Human Resource Management

Implement policies on:

Specific qualifications



Continuing education requirements

Technical personnel:


Licensed, certified or registered (and current copies on file)

final standards28
Final Standards

Consumer Services

Provide clear instructions on use, maintenance and potential hazards of item(s)

Provide expected time frame for receipt of delivered item(s)

Verify item/service was received

Provide contact information and options for rental or purchase

Provide information and telephone numbers for customer assistance:

Regular business hours, after hours, repair, emergencies

final standards29
Final Standards

Performance Management

Implement performance management plan that measures outcomes of customer service, billing practices and adverse events. At a minimum, measure:

  • Beneficiary satisfaction and complaints
  • Timeliness of response to questions, problems and concerns
  • Impact of business practices on adequacy of beneficiary access to items, services, information
  • Frequency of billing/coding errors
  • Adverse events
final standards30
Final Standards

Product Safety

Equipment management program that promotes the safe use of equipment and minimizes safety risks and hazards including:

  • Plan for identifying, monitoring and reporting failures, repair and preventive maintenance
  • Investigate any accident or injury (within 72 hours or 24 hours if results in hospitalization or death)
  • Contingency plan for response to emergencies and disasters
final standards31
Final Standards

Information Management

Maintain accurate, pertinent, accessible, confidential and secure records in accordance with HIPAA and any state standards

other inconspicuous items
Other “Inconspicuous” Items

Health screenings, drug testing and criminal background checks

  • According to state requirements

Infection Control

  • No specific requirement, but certainly required by accreditors

Mail Order

  • “Verify” training and instructions at the time of initial mail order delivery
many concerns
Many Concerns
  • This is not the program that was used in the demonstration project that Congress had in mind when they were voting on this in 2003
  • CMS has been VERY far behind in their timeline
  • They are basing components of the program on information that may be inadequate
    • Focus groups (44 participants in 22 states)
  • Final Rule was released on

April 2, 2007

  • Networks-TODAY
  • Use of American Association for Respiratory Care Practice Guidelines (last updated in 1992)
every organization s must haves
Every Organization’s “Must Haves”
  • Policy and Procedure Manual
  • Complete and Accurate Paperwork for Patients
  • Updated/Complete Educational Materials
  • Competency Program
  • Complete PI Program
must have 1 complete policy and procedure manual
Must Have # 1:Complete Policy and Procedure Manual
  • Must meet the needs and requirements of the accreditation provider you select
  • Not worth trying to create on your own at this point
must have 2 complete paperwork for patients
Must Have # 2:Complete Paperwork for Patients

Such as:

Consent for Treatment/Services


Third Party Review

HIPAA Information

Disaster/Emergency Preparedness

How to Reach the Office (Hours)

must have 3 updated educational materials
Must Have # 3:Updated Educational Materials

Many of the requirements of the standards speak directly to the educational materials you provide to your patients

must have 4 competency program
Must Have # 4:Competency Program
  • Review the requirements of your accreditor and be sure you meet them
  • Generally only technical staff are required to have competency evaluated
  • Can be written (testing) but must be observed for technical staff
must have 5
Must Have # 5

Performance Management

  • Beneficiary satisfaction surveys
  • Patient complaint log
  • After hours (on call) log to prove timeliness of response to questions, problems and concerns
  • Log that documents frequency of billing and/or coding errors
  • Log documenting adverse events (as defined by your P & P manual)

Most accrediting organizations require at least three months of surveys collected and summarized with plans for improvement or you will have to provide written follow-up and possible a re-visit

tips to use in choosing your accreditor
Tips to Use in Choosing Your Accreditor
  • CMS is not your only payer!
    • Payer or state licensure requirements to be accredited
  • What is the accreditor’s schedule and what are the requirements for in-between?
    • Ex:triennial and 18 month written update
  • Fees paid vs. administrative costs
  • Network participation
  • Other services (infusion, home health)
  • Process (electronic vs. paper)
  • Interview/discussions with accrediting organization—your perceptions
  • Your peer’s experience
comparing apples to apples
Comparing “Apples-to-Apples”

Product Category Definitions

DME Limited Mobility Aids: Manual W/C, Cane, Walker, Crutches,

Stationary Commode Chairs, Wound Care and Ostomy Supplies Urological Supplies: Bedpans, Urinals

DME includes Limited and- Manual and Electric Beds, Traction Equipment

Medical Supplies- Diabetic Supplies, Enteral Products (Non-home visit items)

Respiratory- Home medical equipment and supplies covered include respiratory

equipment and supplies, oxygen, concentrators, reservoirs,

conserving devices, cylinders and oxygen accessories and supplies,

home invasive mechanical ventilators, respiratory assist devices,

continuous and intermittent positive pressure breathing devices,


Rehabilitation- Power Mobility devices including complex Rehab and Assistive


Orthotics and Prosthetics- Custom fabricated, custom fitted, custom-made orthotics, prosthetic

devices, somatic, ocular and facial prosthetics, therapeutic shoes, braces

and artificial limbs

accreditation commission for healthcare achc
Accreditation Commission for Healthcare (ACHC)

DME- All Equipment

Medical Suppliers (Pharmacies)



Orthotics and Prosthetics

american board of certification for orthotics and prosthetics abc of o p
American Board of Certification for Orthotics and Prosthetics (ABC of O&P)

Orthotics and Prosthetics

DME Limited- Wound Care/Incontinence, Mobility Aids only if in conjunction with O&P

Merged with the Board for Certification in Pedorthics (

board of orthotic prosthetist certification boc
Board of Orthotic/Prosthetist Certification (BOC)

DME- All Equipment

Medical Suppliers (Pharmacies)


Orthotics and Prosthetics

commission on accreditation of rehabilitation facilities carf
Commission on Accreditation of Rehabilitation Facilities (CARF)


Orthotics and Prosthetics

community health accreditation program chap
Community Health Accreditation Program (CHAP)

DME- All Equipment

Medical Suppliers (Pharmacies)



Orthotics and Prosthetics

the compliance team
The Compliance Team

DME- All Equipment

Medical Suppliers (Pharmacies)



Orthotics and Prosthetics

healthcare quality association on accreditation hqaa
Healthcare Quality Association on Accreditation (HQAA)

DME- All Equipment

Medical Suppliers (Pharmacies)



Orthotics and Prosthetics

joint commission jcaho
Joint Commission (JCAHO)

DME- All Equipment

Medical Suppliers (Pharmacies)



Orthotics and Prosthetics

national association of boards of pharmacy nabp
National Association of Boards of Pharmacy (NABP)

DME Limited- Wound Care/Incontinence, Mobility Aids

Medical Suppliers (Pharmacies)

national board of accreditation for orthotic suppliers nbaos
National Board of Accreditation for Orthotic Suppliers (NBAOS)

Orthotics and Prosthetics

10 things you can do
10 Things You Can Do

10. Download and become VERY comfortable with the final quality standards---read them carefully

9. Monitor the activity of the first 10 MSA’s and updates from the recognized accreditors

8. Review and talk to your payers to make an informed decision as you choose your accreditation provider---especially if you are in any of the first 10 MSA’s

7. Send for your accreditor’s standards and then review and update your P&P (or BUY one!)

6. Identify your team(s)--- review the standards by team and identify what you need to do

10 things you can do56
10 Things You can Do
  • Create a work plan based on what you need to accomplish (Sample at March 2006 issue)
  • Create/review your PI program NOW– begin to collect patient satisfaction data and implement the required logs ASAP--- Gather at least 3 mos of data before notifying accreditor that you are ready

3. Review all patient education materials to see what you will need to update/change so that they match the final standards

2. Review physical plant, warehouse, vehicles

1. Perform a Mock Survey- make corrections

Notify your provider that you’re ready!

Stay Tuned!
  • Work with AAHC on legislative endeavors-
  • More updates from the Recognized Accreditors
  • Conferences held by the “CBIC” to instruct on Competitive Bidding Applications
  • Pricing for items for bid in the MSA
thank you
Thank You!

Mary Ellen Conway


Capital Healthcare Group, LLC

Bethesda, MD