1. CMS Update MedTrade Fall Atlanta, Georgia Tuesday, October 28, 2008 3:00 PM Mary Ellen Conway President

2. 2 Overview What is the Accreditation Requirement? New Deadlines to Know Update on Important Legislation Your Options for Accreditation Tips on Choosing Your Accreditor –Issues with fees/costs

3. 3 Overview Continued How Do You Get Started? “Must Have’s” Video Examples Main Reasons Organizations Fail How Long Does It Take? Ten Things You Can Do Now to be Ready

4. 4 Common Acronyms CMS Center for Medicare Medicaid Services DME Durable Medical Equipment DMEPOSDurable Medical Equipment, Prosthetics, Orthotics and Supplies ESRDEnd Stage Renal Disease HMEHome Medical Equipment MMA ’03Medicare Modernization Act of ’03

5. 5 Download the presentation www.medtrade.com/mt/1500/conference/ Conference_handouts_info.jsp www.capitalhealthcaregroup.com/media

6. 6 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--- this will be enforced initially through the Competitive Bidding Requirement There were between 117,000 and 150,000 Medicare Part B supplier numbers at the start in 2005 This applied to DME’s as well as pharmacies billing for identified items as well as PT’s, MD’s and all others

7. 7 The BIG Announcement ALL providers who expect to receive reimbursement for identified Part B products and supplies must be accredited by September 30, 2009

8. 8 Other Recently Announced Deadlines New DMEPOS suppliers who applied by March 1, 2008 -accreditation by January 1, 2009 New DMEPOS suppliers submitting enrollment applications on or after March 1, 2008- accreditation prior to submitting the application (exempt if more than 25 locations)

9. 9 Newest Deadline If you contract for DME services to a Medicare Certified Hospice, you must be accredited by December 2, 2009 –Medicare Certified Hospices had new Conditions of Participations released on June 5, 2008 requiring that they contract only with accredited DME’s. These regulations so into effect on December 2, 2008.

10. 10 Update on Legislative Activity HR 3331: Medicare Improvements for Patients and Providers Act of 2008

11. 11 Medicare Improvements for Patients and Providers Act of 2008 Passed July 15, 2009 Key Items: Delays Competitive Bidding 18 to 24 months –Scheduled to restart Round 1 in 2009, improves the bidding process and establishes quality measures for DME Repeals title transfer of oxygen concentrators –Now stays with dealer, although at 36 months equipment rental is no longer paid and issues of maintenance and service and payment for those is still to be defined

12. 12 Medicare Improvements for Patients and Providers Act of 2008 To offset the cost savings that were to be accomplished in competitive bidding, all items that were to be included are reduced 9.5%, starting January 1, 2009: Oxygen Supplies and Equipment Standard Power Wheelchairs, Scooters and Related Accessories Complex Rehab Power Chairs and Related Accessories Enteral Nutrients, Equipment and Supplies CPAP, RAD’s and Related Supplies and Accessories Hospital Beds and Related Accessories Mail Order Diabetic Supplies Negative Pressure Wound Therapy Pumps and Related Supplies and Accessories (excluded from Round One) Walkers and Related Accessories

13. 13 Medicare Improvements for Patients and Providers Act of 2008 Quality measures: –Requires contracting suppliers to disclose all subcontracting relationships –Now excludes physicians and other practitioners from DMEPOS accreditation requirements until CMS develops provider specific standards (clarified 9-2-08) –Establishes a separate ombudsman program within CMS to handle supplier and beneficiary issues related to the competitive bidding program

14. 14 Medicare Improvements for Patients and Providers Act of 2008 Excludes Puerto Rico from Round One re- bidding Allows physician and other treating providers to supply “off the shelf” orthotics without being awarded competitive bidding contracts and hospitals to provide those items without contracts Uses a broader definition of physician to cover podiatrist

15. 15 Medicare Improvements for Patients and Providers Act of 2008 Provides Medicare mental health parity –Gradually reduces 50% co-pay to 20% Offer new preventive benefits to Medicare beneficiaries –Makes it easier to add preventive services to the list of Medicare-covered services Extends the exceptions process for therapy caps –Allows for specific diagnosis and procedures to receive coverage after beneficiary has met their therapy cap for the year

16. 16 Medicare Improvements for Patients and Providers Act of 2008 Modifies the Medigap program –Directs HHS to work with the states to establish new requirements for Medigap plans Provides better care for patients with ESRD –“Bundles” all of the costs of ESRD care into a single payment beginning January 1, 2010 –Establishes a new benefit to allow those with advanced disease, but before failure, to learn more about options for dialysis and transplants Provides additional coverage under Part D –Requires Part D to cover benzodiazepines and barbiturates

17. 17 Medicare Improvements for Patients and Providers Act of 2008 Codifies a Part D plan requirement to cover most drugs in certain important classes –Requires coverage of “all or substantially all” drugs in classes for which lack of timely access to medication can result in serious consequences Blocks a scheduled 10.6% cut to physician fees –Averts the cut and increases fees by 1.1% in 2009 Incentivizes adoption of electronic prescribing by physicians –Creates new incentives for MD’s to adopt technology for electronic prescriptions Increases incentives for physician quality reporting –Extends the Medicare Physician Quality Reporting Initiative for services delivered in 2009 and 2010

18. 18 When Do You Need to Be Ready? All others are required to be accredited (whether or not there is Competitive Bidding in your service area when/if it resurfaces in 2009) by September 30, 2009 Other payer, state and regional requirements could be an issue

19. 19 Items Identified by CMS for Accreditation Mobility Assist Equipment Canes and Crutches, Patient Lifts, Walkers, Scooters, Wheelchairs (Standard, Power, Complex, Related Accessories, Seating/Cushions) Respiratory Equipment CPAP, IPPB, RAD’s, High Frequency Chest Wall Oscillation Devices, Invasive Mechanical Ventilation Devices, Invasive Mechanical Ventilation Devices, Ventilators Accessories and Supplies, Intrapulmonary Percussive Ventilation Devices, Intrapulmonary Percussive Ventilation Devices Tracheostomy Care Supplies Oxygen Equipment and Supplies Nebulizer Equipment and Supplies Suction Pumps

20. 20 Durable Medical Equipment Automatic External Defibrillators, Commodes/Urinals/Bedpans, Continuous Passive Motion (CPM) Devices Contracture Treatment Devices: Dynamic Splint Blood Glucose Monitors and Supplies (mail order and non-mail order), Gastric Suction Pumps, Heat and Cold Applications, Hospital Beds (all), Infrared Heating Pad Systems, External Infusion Pumps and Supplies, Insulin Infusion Pumps and Supplies, Implanted Infusion Pumps, Negative Pressure Wound Therapy Pumps and Supplies, Neuromuscular Electrical Stimulators, Osteogenesis Stimulators, Pneumatic Compression Devices, Speech Generating Devices, Support Surfaces/Overlays/Pads, Traction Equipment, Transcutaneous Electrical Nerve Stimulators (TENS Units) Ultraviolet Light Devices, Urologicals, Ostomy Supplies, Wound Care/Surgical Dressings

21. 21 More Items Enteral Nutrients, Equipment and Supplies Parenteral Nutrients, Equipment and Supplies Home Dialysis Equipment and Supplies Diabetic Shoes and Inserts Orthotics: Custom Fabricated Prefabricated (non-custom fabricated) Off-the Shelf Prosthetics: Breast Prostheses and Supplies Limb Prostheses Eye Prostheses Many more items under prosthetics

22. 22 Update “October 2008” Revisions were released last week. www.cms.hhs.gov/MedicareProvide rSupEnrollwww.cms.hhs.gov/MedicareProvide rSupEnroll –Left side of page “DMEPOS Accreditation Updates (found in red) are as follows…

23. 23 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 www.oig.hhs.gov/fraud/exclusions.html 5. The supplier shall comply with all Medicare statutes, regulations (including the disclosure of ownership and control information requirements at 42 CFR §420.201 through §420.206), manuals, program instructions, and contractor policies and articles.

24. 24 Administrative, continued 6. Implement business practices to prevent and control fraud, waste and abuse by: Using procedures that articulate standards of conduct that ensure compliance with applicable laws and regulations. Designate leader(s) responsible for compliance issues

25. 25 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

26. 26 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) Implement policies and issue job descriptions that specify personnel qualifications, training, certifications/licensures where applicable, experience, and continuing education requirements consistent with the specialized equipment, items, and services it provides to beneficiaries; Provide copies of such policies and job descriptions, upon request, to accreditation organizations and government officials or their authorized agents; Verify and maintain copies of licenses, registrations, certifications and competencies for personnel who provide beneficiary services

27. 27 Consumer Services Provide clear written or pictorial, and oral instructions on use, maintenance infection control practices and potential hazards of item(s) as appropriate Provide expected time frame for receipt of delivered item(s) Verify item/service was received Document in the beneficiary’s record the make and model number of any non-custom equipment and/or item(s) provided; Provide contact information and options for rental or purchase Provide information and telephone numbers for customer assistance: Regular business hours, after hours, repair, emergencies If the supplier cannot or will not provide the equipment, item(s) or service(s) that are prescribed for a beneficiary, the supplier shall notify the prescribing physician, practitioner or other healthcare team member promptly, within five calendar days.

28. 28 Consumer Services 3. Within 5 calendar days of receiving a beneficiary’s complaint, the supplier shall notify the beneficiary, using either oral, telephone, e-mail, fax or letter format, that it has received the complaint and is investigating. Within 14 calendar days, the supplier shall provide written notification to the beneficiary of the results of the investigation. The supplier shall maintain documentation of all complaints received, copies of the investigations and responses to the beneficiaries.

29. 29 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 to beneficiaries due to inadequate service(s) or malfunctioning equipment and/or item(s) (e.g injuries, accidents, signs and symptoms of infection, hospitalization) T he supplier shall seek input from employees, customers, and referral sources when assessing the quality of its operations and services.

30. 30 Product Safety The supplier shall: Implement a program that promotes the safe use of equipment and items and minimizes safety risks, infections and hazards both for its staff and for beneficiaries. Implement and maintain a plan for identifying, monitoring, and reporting (where indicated) equipment and item failure, repair, and preventive maintenance provided to beneficiaries. Investigate any incident, injury or infection in which DMEPOS may have contributed to the injury or incident or infection, when the supplier becomes aware. The investigation should be initiated within 24 hours after a supplier becomes aware of an injury, incident or infection resulting in a beneficiary’s hospitalization or death. For other occurrences, the supplier shall investigate within 72 hours after being made aware of the incident, injury or infection. The investigation includes all necessary information, pertinent conclusions about what happened, and whether changes in systems or processes are needed. The supplier should consider possible links between the items and services furnished and the adverse event. Have a contingency plan that enables it to respond to emergencies and disasters or to have arrangements with alternative suppliers in the event that the supplier cannot service its own customers as the result of an emergency or disaster

31. 31 Product Safety Verify, authenticate, and document the following prior to distributing, dispensing, or delivering products to an end-user: –The products are not adulterated, counterfeit, suspected of being counterfeit, and have not been obtained by fraud or deceit; –The products are not misbranded and are appropriately labeled for their intended distribution channels; and –The products were obtained from a distributor or wholesaler approved and authorized by the manufacturer of the products.

32. 32 Appendix B “Complex Rehab” Employ (W-2 employee) at least one qualified individual as a Rehabilitation Technology Supplier (RTS) per location. A qualified RTS is an individual that has one of the following credentials: –Certified Rehabilitation Supplier (CRTS) (discontinued 12/31/08) –Assistive Technology Supplier (ATS) (discontinued 12/31/08) –Assistive Technology Practitioner (ATP) (discontinued 12/31/08) –Assistive Technology Professional (AT) (effective 1/1/09) Completed at least 10 hours annually of continuing education specific to Rehabilitation Technology

33. 33 Not to CONFUSE anyone… Additional Supplier Standards

34. 34 DMEPOS suppliers are not required to disclose the 25 supplier standards to Medicare beneficiaries until the full implementation date - September 30, 2009. Suppliers are encouraged however, to release the updated list of standards as existing reserves are depleted. (Supplier Standard 16 requires DMEPOS suppliers to disclose all supplier standards to each beneficiary to whom it provides a Medicare-covered item.)

35. 35 22. All suppliers must be accredited by a CMS- approved accreditation organization in order to receive and retain a supplier billing number. The accreditation must indicate the specific products and services, for which the supplier is accredited in order for the supplier to receive payment of those specific products and services (except for certain exempt pharmaceuticals). 23. All suppliers must notify their accreditation organization when a new DMEPOS location is opened.

36. 36 24. All supplier locations, whether owned or subcontracted, must meet the DMEPOS quality standards and be separately accredited in order to bill Medicare. 25. All suppliers must disclose upon enrollment all products and services, including the addition of new product lines for which they are seeking accreditation

37. 37 CMS-6036-P This is a 2008 proposed rule to amend DMEPOS enrollment requirements and revise the current supplier standards. Comments were submitted by many stakeholders; the comment period ended March 25, 2008. CMS-6036-P also proposes to add new standards (#26 - #31). A final rule is expected later this year.

38. 38 The proposed Additional Supplier Standards…

39. 39 ( 26) [Reserved] (27) Must obtain oxygen from a State-licensed oxygen supplier (applicable only to those suppliers in States that require oxygen licensure.) Thus if a supplier is located in oxygen license state it must obtain its oxygen from a state licensed oxygen supplier regardless of which state the oxygen supplier obtained its licensure. CMS contends this standard would “promote quality in the furnishing of oxygen.” Effectively, this will prevent suppliers from purchasing oxygen from an outside vendor in a state where a license is required.

40. 40 (28) Is required to maintain ordering and referring documentation, including the NPI, received from a physician, nurse practitioner, physician assistant, clinical social worker, or certified nurse midwife, for 7 years after the claim has been paid. Few comments were submitted on this issue. (29) Is prohibited from sharing a practice location with any other Medicare supplier. This would include physician or physician groups or other DMEPOS suppliers. CMS proposed this requirement because it believed that allowing suppliers to “commingle” locations, staff, inventory and other supplier operations “constitutes a significant risk to the Medicare program.”

41. 41 In addition CMS does not believe that legitimate DMEPOS suppliers routinely share practice locations with other Medicare suppliers. However, CMS noted that it is aware that physicians and other practitioners may supply DMEPOS from their office. CMS solicited comments on whether an exception for physicians and nonphysician practitioners “and the circumstances which warrant an exception” should be established. We await the final standard.

42. 42 (30) Is open to the public a minimum of 30 hours per week, except for those DMEPOS suppliers who are working with custom made or fitted orthotics and prosthetics. CMS proposed this standard because the NSC had found a number of suppliers with posted business hours that were so limited it is “nearly impossible” to conduct an onsite visit or for a beneficiary to obtain services..

43. 43 In addition, CMS contended that most legitimate DMEPOS suppliers are open to the public at least 30 hours per week (either six hours a day, five days a week or five hours a day, six days a week). "We believe that... all legitimate DMEPOS would need to be open at least 30 hours a week in order to attract, retain and serve Medicare beneficiaries," according to the proposal. Industry commenters suggested this could be a significant issue for small providers who must handle both the office activities and deliveries. “We would have to be in the office a significant amount of time, which could limit routine delivery times," one stated.

44. 44 (31) Does not have an Internal Revenue Service (IRS) or a State taxing authority tax delinquency. This is defined as money owed, a conviction for or a charge of tax evasion, or a tax lien. CMS also proposed to revise the enrollment application to require that suppliers certify that it does not have delinquencies and consent to having CMS or a contractor verify that the information. Providers who do not comply with this standard will have billing privileges revoked. In its reasoning, the agency noted a report from the Government Accountability Office that found more than 21,000 providers reimbursed under Part B owed taxes totaling more than $1 billion in 2005.

45. 45 Back to Accreditation!

46. 46 First Steps Choosing Your Accreditor

47. 47 The Recognized Accreditors JCAHO CHAP HQAA ACHC NABP The Compliance Team NB of A for Orthotic Suppliers ABC of O&P BOC CARF

48. 48 Tips to Use in Choosing Your Accreditor CMS is not your only payer! (How about hospice???) –Payer or state licensure requirements to be accredited ex: Anthem BC, State of Florida, Oklahoma Medicaid What is the accreditor’s schedule and what are the requirements for in-between? –ex: Triennial and or annual updates Fees paid vs. administrative costs Other services (infusion, home health) Process (electronic vs. paper) Interview/discussions with accrediting organization— your perceptions--- Who’s downstairs in Accreditation Central? Your peer’s experience

49. 49 One Main Area to Concentrate Performance Improvement

50. 50 Performance Management 1.Beneficiary satisfaction surveys 2.Patient complaint log 3.After hours (on call) log to prove timeliness of response to questions, problems and concerns 4.Log that documents frequency of billing and/or coding errors 5.Log documenting adverse events (as defined by your P & P manual) 6.Log documenting staff and patient infections Many 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

51. 51 Performance Improvement Examples are Everywhere… Where do you see them?

52. 52

53. 53

54. 54

55. 55 Main Reasons Organization Fail Lack of Preparedness Few Staff Aware of Process/Requirements Lack of Focus and Follow-through

56. 56

57. 57

58. 58 Is this your future if you’re not accredited?

59. 59 Stay Tuned! Watch for updates on a weekly basis: AAHC Wednesday in Washington (www.aahomecare.org) Homecare Monday (www.homecaremonday.com) HME News (www.hmenews.com )www.hmenews.com The Friday Report (www.hmetoday.com)

60. 60 Your Questions ???

61. 61 Thank You! Mary Ellen Conway President Capital Healthcare Group, LLC Bethesda, MD 301-896-0193 www.capitalhealthcaregroup.com