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This excerpt taken from the LLY 10-K filed Feb 22, 2010. Regulations
Affecting Pharmaceutical Pricing and Reimbursement
In the United States, we are required to provide rebates to
state governments on their purchases of certain of our products
under state Medicaid programs. Additional cost containment
measures have been adopted or proposed by federal, state, and
local government entities that provide or pay for health care.
In most international markets, we operate in an environment of
government-mandated cost containment programs, which may include
price controls, reference pricing, discounts and rebates,
restrictions on physician prescription levels, restrictions on
reimbursement, compulsory licenses, health economic assessments,
and generic substitution.
In the U.S., the Medicare Prescription Drug Improvement and
Modernization Act of 2003 (MMA) provides a prescription drug
benefit for seniors under the Medicare program, known as
Medicare Part D. Pricing to manufacturers for drugs covered
by the program is currently established through competitive
negotiations
7
between the manufacturers and private payers. In addition,
comprehensive health care reform was the subject of recent
intense debate in Congress, and we expect the health care reform
debate to continue. Although it is difficult to predict the
direction of the debate, the ultimate outcome could have a
material adverse impact on our business. See Item 7,
“Management’s Discussion and Analysis—Executive
Overview—Legal, Regulatory, and Other Matters,” for
more discussion of MMA and U.S. health care reform. At the
state level, budget pressures are causing various states to
impose cost-control measures such as higher rebates and more
restrictive formularies.
International operations are also generally subject to extensive
price and market regulations, and there are many proposals for
additional cost-containment measures, including proposals that
would directly or indirectly impose additional price controls,
limit access to or reimbursement for our products, or reduce the
value of our intellectual property protection.
We cannot predict the extent to which our business may be
affected by these or other potential future legislative or
regulatory developments. However, we expect that pressures on
pharmaceutical pricing will become more severe.
These excerpts taken from the LLY 10-K filed Feb 27, 2009. Regulations
Affecting Pharmaceutical Pricing and Reimbursement
In the United States, we are required to provide rebates to
state governments on their purchases of certain of our products
under state Medicaid programs. Other cost containment measures
have been adopted or proposed by federal, state, and local
government entities that provide or pay for health care. In most
international markets, we operate in an environment of
government-mandated cost containment programs, which may include
price controls, reference pricing, discounts and rebates,
restrictions on physician prescription levels, restrictions on
reimbursement, compulsory licenses, health economic assessments,
and generic substitution.
In the U.S., the Medicare Prescription Drug Improvement and
Modernization Act of 2003 (MMA), took effect in 2006, providing
a prescription drug benefit for seniors under the Medicare
program, known as Medicare Part D. Pricing to manufacturers
for drugs covered by the program is currently established
through competitive negotiations between the manufacturers and
private payers. However, various measures have been proposed
that would allow or require the federal government to negotiate
Medicare Part D drug prices directly with manufacturers. In
addition, various proposals have been introduced that would
increase the rebates we pay to the government. See Part II,
Item 7, “Management’s Discussion and
Analysis − Executive Overview − Legal,
Regulatory, and Other Matters,” for more discussion of MMA
and other federal healthcare cost containment measures. At the
state level, budget pressures are causing various states to
impose cost-control measures such as higher rebates and more
restrictive formularies.
International operations are also generally subject to extensive
price and market regulations, and there are many proposals for
additional cost-containment measures, including proposals that
would directly or indirectly impose additional price controls,
limit access to or reimbursement for our products, or reduce the
value of our intellectual property protection.
We cannot predict the extent to which our business may be
affected by these or other potential future legislative or
regulatory developments. However, we expect that pressures on
pharmaceutical pricing will become more severe.
Regulations Affecting Pharmaceutical Pricing and Reimbursement In the United States, we are required to provide rebates to state governments on their purchases of certain of our products under state Medicaid programs. Other cost containment measures have been adopted or proposed by federal, state, and local government entities that provide or pay for health care. In most international markets, we operate in an environment of government-mandated cost containment programs, which may include price controls, reference pricing, discounts and rebates, restrictions on physician prescription levels, restrictions on reimbursement, compulsory licenses, health economic assessments, and generic substitution.
In the U.S., the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA), took effect in 2006, providing a prescription drug benefit for seniors under the Medicare program, known as Medicare Part D. Pricing to manufacturers for drugs covered by the program is currently established through competitive negotiations between the manufacturers and private payers. However, various measures have been proposed that would allow or require the federal government to negotiate Medicare Part D drug prices directly with manufacturers. In addition, various proposals have been introduced that would increase the rebates we pay to the government. See Part II, Item 7, “Management’s Discussion and Analysis − Executive Overview − Legal, Regulatory, and Other Matters,” for more discussion of MMA and other federal healthcare cost containment measures. At the state level, budget pressures are causing various states to impose cost-control measures such as higher rebates and more restrictive formularies. International operations are also generally subject to extensive price and market regulations, and there are many proposals for additional cost-containment measures, including proposals that would directly or indirectly impose additional price controls, limit access to or reimbursement for our products, or reduce the value of our intellectual property protection. We cannot predict the extent to which our business may be affected by these or other potential future legislative or regulatory developments. However, we expect that pressures on pharmaceutical pricing will become more severe. These excerpts taken from the LLY 10-K filed Oct 21, 2008. Regulations
Affecting Pharmaceutical Pricing and Reimbursement
In the United States, we are required to provide rebates to
state governments on their purchases of certain of our products
under state Medicaid programs. Other cost containment measures
have been adopted or proposed by federal, state, and local
government entities that provide or pay for health care. In most
international markets, we operate in an environment of
government-mandated cost containment programs, which may include
price controls, reference pricing, discounts and rebates,
restrictions on physician prescription levels, restrictions on
reimbursement, compulsory licenses, health economic assessments,
and generic substitution.
In the U.S., implementation of the Medicare Prescription Drug,
Improvement and Modernization Act of 2003 (MMA), providing a
prescription drug benefit under the Medicare program, took
effect January 1, 2006. See Part II, Item 7,
“Management’s Discussion and Analysis –
Executive Overview – Legal, Regulatory, and Other
Matters” for more discussion of MMA and other federal
healthcare cost containment measures. At the state level, budget
pressures are causing various states to impose cost-control
measures such as higher rebates and more restrictive formularies.
International operations are also generally subject to extensive
price and market regulations, and there are many proposals for
additional cost-containment measures, including proposals that
would directly or indirectly impose additional price controls,
limit access to or reimbursement for our products, or reduce the
value of our intellectual property protection.
We cannot predict the extent to which our business may be
affected by these or other potential future legislative or
regulatory developments. However, we expect that pressures on
pharmaceutical pricing will continue to increase.
Regulations Affecting Pharmaceutical Pricing and Reimbursement In the United States, we are required to provide rebates to state governments on their purchases of certain of our products under state Medicaid programs. Other cost containment measures have been adopted or proposed by federal, state, and local government entities that provide or pay for health care. In most international markets, we operate in an environment of government-mandated cost containment programs, which may include price controls, reference pricing, discounts and rebates, restrictions on physician prescription levels, restrictions on reimbursement, compulsory licenses, health economic assessments, and generic substitution. In the U.S., implementation of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), providing a prescription drug benefit under the Medicare program, took effect January 1, 2006. See Part II, Item 7, “Management’s Discussion and Analysis – Executive Overview – Legal, Regulatory, and Other Matters” for more discussion of MMA and other federal healthcare cost containment measures. At the state level, budget pressures are causing various states to impose cost-control measures such as higher rebates and more restrictive formularies. International operations are also generally subject to extensive price and market regulations, and there are many proposals for additional cost-containment measures, including proposals that would directly or indirectly impose additional price controls, limit access to or reimbursement for our products, or reduce the value of our intellectual property protection. We cannot predict the extent to which our business may be affected by these or other potential future legislative or regulatory developments. However, we expect that pressures on pharmaceutical pricing will continue to increase. These excerpts taken from the LLY 10-K filed Feb 29, 2008. Regulations
Affecting Pharmaceutical Pricing and Reimbursement
In the United States, we are required to provide rebates to
state governments on their purchases of certain of our products
under state Medicaid programs. Other cost containment measures
have been adopted or proposed by federal, state, and local
government entities that provide or pay for health care. In most
international markets, we operate in an environment of
government-mandated cost containment programs, which may include
price controls, reference pricing, discounts and rebates,
restrictions on physician prescription levels, restrictions on
reimbursement, compulsory licenses, health economic assessments,
and generic substitution.
In the U.S., implementation of the Medicare Prescription Drug,
Improvement and Modernization Act of 2003 (MMA), providing a
prescription drug benefit under the Medicare program, took
effect January 1, 2006. See Part II, Item 7,
“Management’s Discussion and Analysis –
Executive Overview – Legal, Regulatory, and Other
Matters” for more discussion of MMA and other federal
healthcare cost containment measures. At the state level, budget
pressures are causing various states to impose cost-control
measures such as higher rebates and more restrictive formularies.
International operations are also generally subject to extensive
price and market regulations, and there are many proposals for
additional cost-containment measures, including proposals that
would directly or indirectly impose additional price controls,
limit access to or reimbursement for our products, or reduce the
value of our intellectual property protection.
We cannot predict the extent to which our business may be
affected by these or other potential future legislative or
regulatory developments. However, we expect that pressures on
pharmaceutical pricing will continue to increase.
Regulations Affecting Pharmaceutical Pricing and Reimbursement In the United States, we are required to provide rebates to state governments on their purchases of certain of our products under state Medicaid programs. Other cost containment measures have been adopted or proposed by federal, state, and local government entities that provide or pay for health care. In most international markets, we operate in an environment of government-mandated cost containment programs, which may include price controls, reference pricing, discounts and rebates, restrictions on physician prescription levels, restrictions on reimbursement, compulsory licenses, health economic assessments, and generic substitution. In the U.S., implementation of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), providing a prescription drug benefit under the Medicare program, took effect January 1, 2006. See Part II, Item 7, “Management’s Discussion and Analysis – Executive Overview – Legal, Regulatory, and Other Matters” for more discussion of MMA and other federal healthcare cost containment measures. At the state level, budget pressures are causing various states to impose cost-control measures such as higher rebates and more restrictive formularies. International operations are also generally subject to extensive price and market regulations, and there are many proposals for additional cost-containment measures, including proposals that would directly or indirectly impose additional price controls, limit access to or reimbursement for our products, or reduce the value of our intellectual property protection. We cannot predict the extent to which our business may be affected by these or other potential future legislative or regulatory developments. However, we expect that pressures on pharmaceutical pricing will continue to increase. This excerpt taken from the LLY 10-K filed Feb 28, 2007. Regulations
Affecting Pharmaceutical Pricing and Reimbursement
In the United States, we are required to provide rebates to
state governments on their purchases of certain of our products
under state Medicaid programs. Other cost containment measures
have been adopted or proposed by federal, state, and local
government entities that provide or pay for health care. In most
international markets, we operate in an environment of
government-mandated cost containment programs, which may include
price controls, reference pricing, discounts and rebates,
restrictions on physician prescription levels, restrictions on
reimbursement, compulsory licenses, health economic assessments,
and generic substitution.
In the U.S., implementation of the Medicare Prescription Drug,
Improvement and Modernization Act of 2003 (MMA), providing a
prescription drug benefit under the Medicare program, took
effect January 1, 2006. See Part II, Item 7,
“Management’s Discussion and Analysis –
Executive Overview – Legal and Governmental
Matters” for a discussion of the impact of MMA and other
federal and state healthcare cost containment measures.
International operations are also generally subject to extensive
price and market regulations, and there are many proposals for
additional cost-containment measures, including proposals that
would directly or indirectly impose additional price controls or
reduce the value of our intellectual property protection.
We cannot predict the extent to which our business may be
affected by these or other potential future legislative or
regulatory developments. However, we expect that pressures on
pharmaceutical pricing will continue to increase.
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