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

1. It’s 2007! Mandatory Accreditation is Here!Are You Prepared?Wednesday, April 25, 2007MedTrade Spring Mary Ellen Conway President

2. 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 • First Ten Products for Bidding • Final Quality Standards • Inconspicuous Items” • Concerns

3. 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

4. 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by 2007--- this will be enforced initially through the Competitive Bidding Requirement • January 26 announcement rescinded BUT TODAY???

5. 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)

6. Who Are the Recognized Accreditors?…And then there were ten… Changed January 2007 JCAHO NB of A for Orthotic Suppliers CHAP CARF HQAA BOC ACHC NABP ABC of O&P The Compliance Team

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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 NOT MUCH TIME!

13. 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

14. 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

15. 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

16. Current Legislative Activity • Tanner Hobson (formerly Hobson Tanner) www.aahomecare.orgAdvocacy Updates Also: Price Repeal of 36 mo Oxygen Cap (H.R. 621)

17. 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

18. Product Selection • CMS selected products for CB based on: • High cost • High-volume • Greatest potential for savings

19. 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.)cms.hhs.gov/CompetitiveAcqforDMEPOS/04_New_Quality_Standards.asp • Compliance with these standards will be enforced through the accreditation provider you select

20. Final Supplier Quality Standards 2 Sections First Section: Business Services • Administration • Financial Management • Human Resource Management • Consumer Services • Performance Management • Product Safety • Information Management

21. 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

22. 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

23. 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

24. 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

25. Final Standards Administrative 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 www.oig.hhs.gov/fraud/exclusions.html 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

26. 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

27. Final Standards Human Resource Management Implement policies on: Specific qualifications Training Experience Continuing education requirements Technical personnel: Competent Licensed, certified or registered (and current copies on file)

28. 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

29. 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

30. 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

31. Final Standards Information Management Maintain accurate, pertinent, accessible, confidential and secure records in accordance with HIPAA and any state standards

32. 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

33. 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)

34. Clarifications • Final Rule was released on April 2, 2007 • Networks-TODAY • Use of American Association for Respiratory Care Practice Guidelines (last updated in 1992)

35. Every Organization’s “Must Haves” • Policy and Procedure Manual • Complete and Accurate Paperwork for Patients • Updated/Complete Educational Materials • Competency Program • Complete PI Program

36. 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

37. Must Have # 2:Complete Paperwork for Patients Such as: Consent for Treatment/Services AOB Third Party Review HIPAA Information Disaster/Emergency Preparedness How to Reach the Office (Hours)

38. Must Have # 3:Updated Educational Materials Many of the requirements of the standards speak directly to the educational materials you provide to your patients

39. 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

40. 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

41. How Do I Get Started???

42. 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

43. The Current Ten Recognized Accreditors

44. 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, nebulizers Rehabilitation- Power Mobility devices including complex Rehab and Assistive Technology Orthotics and Prosthetics- Custom fabricated, custom fitted, custom-made orthotics, prosthetic devices, somatic, ocular and facial prosthetics, therapeutic shoes, braces and artificial limbs

45. Accreditation Commission for Healthcare (ACHC) www.achc.org DME- All Equipment Medical Suppliers (Pharmacies) Respiratory Rehabilitation Orthotics and Prosthetics

46. American Board of Certification for Orthotics and Prosthetics (ABC of O&P) www.abcop.org 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 (www.cpeds.org)

47. Board of Orthotic/Prosthetist Certification (BOC) www.bocusa.org DME- All Equipment Medical Suppliers (Pharmacies) Respiratory Orthotics and Prosthetics

48. Commission on Accreditation of Rehabilitation Facilities (CARF) www.carf.org Rehabilitation Orthotics and Prosthetics

49. Community Health Accreditation Program (CHAP) www.chapinc.org DME- All Equipment Medical Suppliers (Pharmacies) Respiratory Rehabilitation Orthotics and Prosthetics

50. The Compliance Team www.exemplaryprovider.com DME- All Equipment Medical Suppliers (Pharmacies) Respiratory Rehabilitation Orthotics and Prosthetics