NHIA 3rd Annual Legislative Conference – June 19, 2007

The Medicare Home Infusion

Coverage Act of 2007 (H.R. 2567)

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)

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

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

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

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

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

Definitions

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

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

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

Definitions (Cont’d)

A qualified home infusion therapy provider may subcontract with a pharmacy, physician, provider or supplier to meet these requirements.

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

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

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

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

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

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

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.”

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

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

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

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

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

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

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

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

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

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

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

What We Need to Do Now (Cont’d)

Develop support from other outside groups

Patient organizations

Other provider organizations

What We Need to Do Now (Cont’d)

Congressional Hearings

Dialogue with DHHS

Congressional Budget Office analysis

Don Moran analysis

Funded by BIO

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

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

                   

Your Grassroots Efforts 

Essential to success on this legislation

Essential to NHIA role in policymaking

CONTACT INFORMATION

aparver@pogolaw.com