1. NHIA 3 rd Annual Legislative Conference – June 19, 2007 The Medicare Home Infusion Coverage Act of 2007 (H.R. 2567)

2. Basic Facts about H.R. 2567 Introduced in the House of Representatives on June 5, 2007 Primary sponsor is Eliot Engel (D-NY), member of House Energy & Commerce Committee Other initial sponsors: Kay Granger (R-TX)

3. Basic Facts about H.R. 2567 (Cont’d) Tammy Baldwin (D-WI) – E&C Chip Pickering (R-MS) – E&C Randy Kuhl (R-NY) John Tierney (D-MA) Effective date of statute – January 1, 2008

4. Basic Approach of H.R. 2567 Cover infusion-related services, supplies and equipment under Medicare Part B Consolidate coverage of infusion drugs in Part D Develop national standards for provision of infusion therapy

5. Coverage of Professional Services, Supplies and Equipment (Cont’d) The bill adds a new Part B benefit to the Social Security Act entitled “Home Infusion Therapy” The definition of home infusion therapy encompasses professional services (other than nursing services) and all necessary supplies and equipment for the provision of home infusion therapy

6. Coverage of Professional Services, Supplies and Equipment (Cont’d) Definition separately includes nursing services, except for nursing services that are covered under the home health benefit

7. Coverage of Professional Services, Supplies and Equipment (Cont’d) The Secretary must establish uniform standards of care, based on Standards used by Medicare Advantage plans Standards commonly used in the private sector Consultation with stakeholders

8. Definitions “Home” is defined as an individual’s residence and may include other settings as the Secretary determines

9. Definitions (Cont’d) “Qualified home infusion therapy provider” is defined as any pharmacy, physician or other provider licensed by the State and who has expertise in preparation of parenteral medications in compliance with enforceable standards of the USP

10. Definitions (Cont’d) provides infusion therapy to patients requiring parenteral administration of drugs and biologicals administered through catheters and/or needles in the home setting, and meets the standards established by the Secretary for the safe and effective provision of home infusion therapy on a 7-day a week, 24-hour a day basis

11. Definitions (Cont’d) A qualified home infusion therapy provider may subcontract with a pharmacy, physician, provider or supplier to meet these requirements.

12. Payment for Infusion Services, Supplies and Equipment under Medicare Part B (Cont’d) The Secretary shall establish a per diem payment schedule for the professional services (other than nursing), supplies and equipment

13. Payment for Infusion Services, Supplies and Equipment under Medicare Part B (Cont’d) The per diem schedule must reflect reasonable costs of providing home infusion therapy in conformance with applicable laws, regulations and standards, and which assures patients’ reasonable access to home infusion therapy

14. Payment for Infusion Services, Supplies and Equipment under Medicare Part B (Cont’d) The payment schedule shall be updated by the percentage increase of the CPI- Urban Index for the 12-month period ending in June of the preceding year

15. Payment for Infusion Nursing Services under Medicare Part B The Secretary must develop a payment methodology (outside of the per diem) that reflects the cost of providing infusion nursing services in compliance with applicable laws, regulations and standards and which assures Medicare beneficiaries of reasonable access to home infusion therapy

16. Payment for Infusion Nursing Services under Medicare Part B (Cont’d) The payment amounts must be updated similarly to the other professional services, supplies and equipment

17. Medicare Coverage of Home Infusion Drugs Consolidates coverage of home infusion drugs under Part D Terminates coverage of infusion drugs under the durable medical equipment benefit

18. Medicare Coverage of Home Infusion Drugs (Cont’d) Defines infusion drug as “A parenteral drug or biological administered via an intravenous, intraspinal, intra-arterial, intrathecal, epidural, subcutaneous, or intramuscular access device inserted into the body, and includes a drug used for catheter maintenance and declotting, a drug contained in a device, vitamins, intravenous solutions, diluents and minerals, and other components used in the provision of home infusion therapy.”

19. Infusion Drug Formularies Open formularies required for infusion drugs for first two years USP to develop a model formulary for infusion drugs to guide prescription drug plans after the first two years

20. Why Keep Infusion Drugs in Part D? Most infusion drugs already are covered under Part D Lower budget score Broaden support for the bill among physicians and manufacturers Avoid average sales price issues

21. Payment for Infusion Drugs under Part D Generally, same as other Part D drugs Negotiated prices and fee schedules Specific infusion drug provisions Detailed definition of infusion drug Must qualify patients quickly to ensure meaningful access Formulary provisions

22. Coordination between Part B and Part D The Secretary is required to make the benefit work as seamlessly as possible Beneficiaries must have timely and appropriate access to home infusion therapy

23. Coordination between Part B and Part D (Cont’d) The Secretary must minimize administrative burdens Consider consolidated claims Medical necessity determinations made by Part B carrier and communicated to appropriate prescription drug plan or MA-PD

24. Coordination between Part B and Part D (Cont’d) Coverage for ninety-day periods The Secretary must model the benefit on private sector coverage and coding for home infusion therapy

25. Home Infusion Therapy Advisory Panel The Secretary must establish an advisory panel to assist in development and implementation of benefit Members shall include Qualified home infusion therapy providers and their representative organizations

26. Home Infusion Therapy Advisory Panel (Cont’d) Patient organizations Hospital discharge planners, care coordinators or social workers Prescription drug plan sponsors and Medicare Advantage organizations

27. Government Accountability Office Report Submit report to Congress on beneficiary access to home infusion therapy by January 1, 2010 and every two years thereafter Determine if objectives of this legislation have been met Provide Congress with recommendations to ensure appropriate access to therapy

28. Next Steps, If Enacted… Congressional report language to clarify several technical issues Many details to be worked out with DHHS via the regulatory process On-going consultative role in fashioning a workable benefit

29. What We Need to Do Now Develop widespread support for bill in both houses of Congress Senate version of the bill Attract more co-sponsors

30. What We Need to Do Now (Cont’d) Develop support from other outside groups Patient organizations Other provider organizations

31. What We Need to Do Now (Cont’d) Congressional Hearings Dialogue with DHHS Congressional Budget Office analysis Don Moran analysis Funded by BIO

32. Difference between 2006 and 2007 Part D is not untouchable in 2007 Strong support within House Energy & Commerce Committee Congressman Engel and Congresswoman Baldwin serve on Health Subcommittee

33. Difference between 2006 and 2007 (Cont’d) Congressman Pickering is a member of full Committee Broader support from other infusion stakeholders But Cost analysis and score still loom as major issues

34. Your Grassroots Efforts Essential to success on this legislation Essential to NHIA role in policymaking

35. CONTACT INFORMATION aparver@pogolaw.com