Transcript www.nhia.org

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 CPIUrban 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
 Medical
consolidated claims
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
 Other
organizations
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
[email protected]