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ELN » Topics » If we fail to comply with our reporting and payment obligations under the Medicaid rebate program or other governmental pricing programs, then we could be subject to additional reimbursements, penalties, sanctions and fines, which could have a material adThis excerpt taken from the ELN 20-F filed Feb 26, 2009. If we
fail to comply with our reporting and payment obligations under
the Medicaid rebate program or other governmental pricing
programs, then we could be subject to material reimbursements,
penalties, sanctions and fines.
As a condition of reimbursement under Medicaid, we participate
in the U.S. federal Medicaid rebate program, as well as
several state rebate programs. Under the federal and state
Medicaid rebate programs, we pay a rebate to each state for our
products that are reimbursed by those programs. The amount of
the rebate for each unit of product is set by law, based on
reported pricing data. The rebate amount may also include a
penalty if our prices increase faster than the rate of inflation.
As a manufacturer of single-source, innovator and non-innovator
multiple-source products, rebate calculations vary among
products and programs. The calculations are complex and, in some
respects, subject to interpretation by governmental or
regulatory agencies, the courts and us. The Medicaid rebate
amount is computed each quarter based on our pricing data
submission to the Centers for Medicare and Medicaid Services at
the U.S. Department of Health and Human Services. The terms
of our participation in the program impose an obligation to
correct the prices reported in previous quarters, as may be
necessary. Any such corrections could result in an overage or
shortfall in our rebate liability for past quarters (up to 12
past quarters), depending on the direction of the correction.
Governmental agencies may also make changes in program
interpretations, requirements or conditions of participation,
some of which may have implications for amounts previously
estimated or paid.
U.S. federal law requires that any company that
participates in the federal Medicaid rebate program extend
comparable discounts to qualified purchasers under the Public
Health Service’s pharmaceutical pricing program. This
pricing program extends discounts comparable to the Medicaid net
price to a variety of community health clinics and other
entities that receive health services grants from the Public
Health Service, as well as outpatient utilization at hospitals
that serve a disproportionate share of poor patients.
Additionally, each calendar quarter, we calculate and report an
Average Sales Price (ASP) for all products covered by Medicare
Part B (primarily injectable or infused products). We
submit ASP information for each such product within 30 days
of the end of each calendar quarter. This information is then
used to set reimbursement levels to reimburse Part B
providers for the drugs and biologicals dispensed to Medicare
Part B participants.
Table of Contents
Furthermore, pursuant to the Veterans Health Care Act, a
Non-Federal Average Manufacturer Price is calculated each
quarter and a Federal Ceiling Price is calculated each year for
every Covered Drug marketed by us. These prices are used to set
pricing for purchases by the military arm of the government.
These price reporting obligations are complicated and often
involve decisions regarding issues for which there is no
clear-cut guidance from the government. Failure to submit
correct pricing data can subject us to material civil,
administrative and criminal penalties.
This excerpt taken from the ELN 20-F filed Feb 28, 2008. If we
fail to comply with our reporting and payment obligations under
the Medicaid rebate program or other governmental pricing
programs, then we could be subject to material reimbursements,
penalties, sanctions and fines.
As a condition of reimbursement under Medicaid, we participate
in the U.S. federal Medicaid rebate program, as well as
several state rebate programs. Under the federal and state
Medicaid rebate programs, we pay a rebate to each state for our
products that are reimbursed by those programs. The amount of
the rebate for each unit of product is set by law, based on
reported pricing data. The rebate amount may also include a
penalty if our prices increase faster than the rate of inflation.
As a manufacturer of single-source, innovator and non-innovator
multiple-source products, rebate calculations vary among
products and programs. The calculations are complex and, in some
respects, subject to interpretation by governmental or
regulatory agencies, the courts and us. The Medicaid rebate
amount is computed each quarter based on our pricing data
submission to the Centers for Medicare and Medicaid Services at
the U.S. Department of Health and Human Services. The terms
of our participation in the program impose an obligation to
correct the prices reported in previous quarters, as may be
necessary. Any such corrections could result in an overage or
shortfall in our rebate liability for past quarters (up to 12
past quarters), depending on the direction of the correction.
Governmental agencies may also make changes in program
interpretations, requirements or conditions of participation,
some of which may have implications for amounts previously
estimated or paid.
Table of Contents
U.S. Federal law requires that any company that
participates in the federal Medicaid rebate program extend
comparable discounts to qualified purchasers under the Public
Health Services pharmaceutical pricing program. This pricing
program extends discounts comparable to the Medicaid net price
to a variety of community health clinics and other entities that
receive health services grants from the Public Health Service,
as well as outpatient utilization at hospitals that serve a
disproportionate share of poor patients.
Additionally, each calendar quarter, we calculate and report an
Average Sales Price (ASP) for all products covered by Medicare
Part B (primarily injectable or infused products). We
submit ASP information for each such product within 30 days
of the end of each calendar quarter. This information is then
used to set reimbursement levels to reimburse Part B
providers for the drugs and biologicals dispensed to Medicare
Part B participants.
Furthermore, pursuant to the Veterans Health Care Act, a
Non-Federal Average Manufacturer Price is calculated each
quarter and a Federal Ceiling Price is calculated each year for
every Covered Drug marketed by us. These prices are used to set
pricing for purchases by the military arm of the government.
These price reporting obligations are complicated and often
involve decisions regarding issues for which there is no
clear-cut guidance from the government. Failure to submit
correct pricing data can subject us to material civil,
administrative and criminal penalties.
This excerpt taken from the ELN 20-F filed Feb 28, 2007. If we
fail to comply with our reporting and payment obligations under
the Medicaid rebate program or other governmental pricing
programs, then we could be subject to additional reimbursements,
penalties, sanctions and fines, which could have a material
adverse effect on our business.
As a condition of reimbursement under Medicaid, we participate
in the US federal Medicaid rebate program, as well as several
state rebate programs. Under the federal and state Medicaid
rebate programs, we pay a rebate to each state for our products
that are reimbursed by those programs. The amount of the rebate
for each unit of product is set by law based on reported pricing
data. The rebate amount may also include a penalty if our prices
increase faster than the rate of inflation.
As a manufacturer of single source, innovator and non-innovator
multiple source products, rebate calculations vary among
products and programs. The calculations are complex and, in some
respects, subject to interpretation by
Table of Contents
governmental or regulatory agencies, the courts and us. The
Medicaid rebate amount is computed each quarter based on our
pricing data submission to the Centers for Medicare and Medicaid
Services at the US Department of Health and Human Services. The
terms of our participation in the program impose an obligation
to correct the prices reported in previous quarters, as may be
necessary. Any such corrections could result in an overage or
shortfall in our rebate liability for past quarters (up to 12
past quarters), depending on the direction of the correction.
Governmental agencies may also make changes in program
interpretations, requirements or conditions of participation,
some of which may have implications for amounts previously
estimated or paid.
US Federal law requires that any company that participates in
the federal Medicaid rebate program extend comparable discounts
to qualified purchasers under the Public Health Services
pharmaceutical pricing program. This pricing program extends
discounts comparable to the Medicaid net price to a variety of
community health clinics and other entities that receive health
services grants from the Public Health Service, as well as
outpatient utilization at hospitals that serve a
disproportionate share of poor patients.
Additionally, each calendar quarter, we calculate and report an
Average Sales Price (ASP) for all products covered by Medicare
Part B (primarily injectable or infused products). We
submit ASP information for each such product within 30 days
of the end of each calendar quarter. This information is then
used to set reimbursement levels to reimburse Part B
providers for the drugs and biologicals dispensed to Medicare
Part B participants.
Furthermore, pursuant to the Veterans Health Care Act, a
Non-Federal Average Manufacturer Price is calculated each
quarter and a Federal Ceiling Price is calculated each year for
every Covered Drug marketed by us. These prices are used to set
pricing for purchases by the military arm of the government.
These price reporting obligations are complicated and often
involve decisions regarding issues for which there is no
clear-cut guidance from the government. Failure to submit
correct pricing data can subject us to civil, administrative,
and criminal penalties, and could have a material adverse effect
on our business, financial condition and results of operations.
This excerpt taken from the ELN 20-F filed Mar 30, 2006. If we
fail to comply with our reporting and payment obligations under
the Medicaid rebate program or other governmental pricing
programs, then we could be subject to additional reimbursements,
penalties, sanctions and fines, which could have a material
adverse effect on our business.
As a condition of reimbursement under Medicaid, we participate
in the U.S. federal Medicaid rebate program, as well as
several state rebate programs. Under the federal and state
Medicaid rebate programs, we pay a rebate to each state for our
products that are reimbursed by those programs. The amount of
the rebate for each unit of product is set by law based on
reported pricing data. The rebate amount may also include a
penalty if our prices increase faster than the rate of inflation.
As a manufacturer of single source, innovator and non-innovator
multiple source products, rebate calculations vary among
products and programs. The calculations are complex and, in some
respects, subject to interpretation by governmental or
regulatory agencies, the courts and us. The Medicaid rebate
amount is computed each quarter based on our pricing data
submission to the Centers for Medicare and Medicaid Services at
the U.S. Department of Health and Human Services. The terms
of our participation in the program impose an obligation to
correct the prices reported in previous quarters, as may be
necessary. Any such corrections could result in an overage or
shortfall in our rebate liability for past quarters (up to 12
past quarters), depending on the direction of the correction.
Governmental agencies may also make changes in program
interpretations, requirements or conditions of participation,
some of which may have implications for amounts previously
estimated or paid.
U.S. Federal law requires that any company that
participates in the federal Medicaid rebate program extend
comparable discounts to qualified purchasers under the Public
Health Services pharmaceutical pricing program. This pricing
program extends discounts comparable to the Medicaid net price
to a variety of community health clinics and other entities that
receive health services grants from the Public Health Service,
as well as outpatient utilization at hospitals that serve a
disproportionate share of poor patients.
Additionally, each calendar quarter, we calculate and report an
Average Sales Price (ASP) for all products covered by Medicare
Part B (primarily injectable or infused products). We
submit ASP information for each such product within 30 days
of the end of each calendar quarter. This information is then
used to set reimbursement levels to reimburse Part B
providers for the drugs and biologicals dispensed to Medicare
Part B participants.
Furthermore, pursuant to the Veterans Health Care Act, a
Non-Federal Average Manufacturer Price is calculated each
quarter and a Federal Ceiling Price is calculated each year for
every Covered Drug marketed by us. These prices are used to set
pricing for purchases by the military arm of the government.
These price reporting obligations are complicated and often
involve decisions regarding issues for which there is no
clear-cut guidance from the government. Failure to submit
correct pricing data can subject us to civil, administrative,
and criminal penalties, and could have a material adverse effect
on our business, financial condition and results of operations.
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