Alicia Ault

Beginning next year, health insurance companies will be required to prove that they spend at least 80% of premium dollars collected on direct medical care and quality improvement efforts under new federal regulations issued Nov. 22.

The interim final rule takes effect Jan. 1 and was required by the Affordable Care Act. The so-called medical loss ratio rule was developed by the National Association of Insurance Commissioners, which submitted its recommendations to the Health and Human Services department in late October.

According to the rule, HHS will review insurers' medical loss data at the end of 2010. Companies that spend less than 80%-85% of their premium dollar on direct medical care will be required to issue rebates to consumers, said HHS Secretary Kathleen Sebelius at a press briefing. The rebate checks will begin arriving in 2012.

In some markets, insurers spend as little as 60% of the premium dollar on direct care, said Ms. Sebelius, who added that under the rule, those companies might have "to return nearly $3,500 to every family they insure." Her calculation was based on an average annual premium of $13,250 paid by a family of four.

Ms. Sebelius and other HHS officials said the rule was an important new consumer law. An estimated 74.8 million Americans will be protected by the new medical loss ratio requirements, and up to 9 million Americans could be eligible for rebates in the first year, according to HHS.

Timothy Jost, a professor of law at Washington and Lee University, Lexington, Va., who advised the NAIC task force, said he estimated that insurers currently spend 12% of the premium dollar on pharmaceuticals and 31% for physician services, and 31% on administrative costs.

The rule "will drive insurers to become more efficient," and "incentivize them to not raise premiums more than necessary," Mr. Jost said during the briefing.

Perhaps in response to opponents who have complained that the passage of the ACA was a closed-door process, HHS and NAIC officials at the briefing said that the medical loss ratio rule had been developed in a very public fashion, with open hearings.

"These rules were carefully developed through a transparent and fair process with significant input from the public, the states, and other key stakeholders," said Jay Angoff, director of the HHS Office of Consumer Information and Insurance Oversight.

Jane Cline, president of the NAIC and insurance commissioner for West Virginia, said there were safeguards in the rule to ensure that it would not destabilize the insurance markets. The HHS Secretary will have the ability to adjust the medical loss ratio on a state-by-state basis to ensure that there is access to insurance, Ms. Cline said.

Four states – Maine, Iowa, South Carolina, and Georgia – have already asked HHS to change the requirements for insurers operating there; others could follow suit, Mr. Angoff said.

Transparency will be required of insurers as well. Starting in 2011 they will have to report publicly how they spend their premium dollars.

Beginning next year, health insurance companies will be required to prove that they spend at least 80% of premium dollars collected on direct medical care and quality improvement efforts under new federal regulations issued Nov. 22.

The interim final rule takes effect Jan. 1 and was required by the Affordable Care Act. The so-called medical loss ratio rule was developed by the National Association of Insurance Commissioners, which submitted its recommendations to the Health and Human Services department in late October.

According to the rule, HHS will review insurers' medical loss data at the end of 2010. Companies that spend less than 80%-85% of their premium dollar on direct medical care will be required to issue rebates to consumers, said HHS Secretary Kathleen Sebelius at a press briefing. The rebate checks will begin arriving in 2012.

In some markets, insurers spend as little as 60% of the premium dollar on direct care, said Ms. Sebelius, who added that under the rule, those companies might have "to return nearly $3,500 to every family they insure." Her calculation was based on an average annual premium of $13,250 paid by a family of four.

Ms. Sebelius and other HHS officials said the rule was an important new consumer law. An estimated 74.8 million Americans will be protected by the new medical loss ratio requirements, and up to 9 million Americans could be eligible for rebates in the first year, according to HHS.

Timothy Jost, a professor of law at Washington and Lee University, Lexington, Va., who advised the NAIC task force, said he estimated that insurers currently spend 12% of the premium dollar on pharmaceuticals and 31% for physician services, and 31% on administrative costs.

The rule "will drive insurers to become more efficient," and "incentivize them to not raise premiums more than necessary," Mr. Jost said during the briefing.

Perhaps in response to opponents who have complained that the passage of the ACA was a closed-door process, HHS and NAIC officials at the briefing said that the medical loss ratio rule had been developed in a very public fashion, with open hearings.

"These rules were carefully developed through a transparent and fair process with significant input from the public, the states, and other key stakeholders," said Jay Angoff, director of the HHS Office of Consumer Information and Insurance Oversight.

Jane Cline, president of the NAIC and insurance commissioner for West Virginia, said there were safeguards in the rule to ensure that it would not destabilize the insurance markets. The HHS Secretary will have the ability to adjust the medical loss ratio on a state-by-state basis to ensure that there is access to insurance, Ms. Cline said.

Four states – Maine, Iowa, South Carolina, and Georgia – have already asked HHS to change the requirements for insurers operating there; others could follow suit, Mr. Angoff said.

Transparency will be required of insurers as well. Starting in 2011 they will have to report publicly how they spend their premium dollars.

Beginning next year, health insurance companies will be required to prove that they spend at least 80% of premium dollars collected on direct medical care and quality improvement efforts under new federal regulations issued Nov. 22.

The interim final rule takes effect Jan. 1 and was required by the Affordable Care Act. The so-called medical loss ratio rule was developed by the National Association of Insurance Commissioners, which submitted its recommendations to the Health and Human Services department in late October.

According to the rule, HHS will review insurers' medical loss data at the end of 2010. Companies that spend less than 80%-85% of their premium dollar on direct medical care will be required to issue rebates to consumers, said HHS Secretary Kathleen Sebelius at a press briefing. The rebate checks will begin arriving in 2012.

In some markets, insurers spend as little as 60% of the premium dollar on direct care, said Ms. Sebelius, who added that under the rule, those companies might have "to return nearly $3,500 to every family they insure." Her calculation was based on an average annual premium of $13,250 paid by a family of four.

Ms. Sebelius and other HHS officials said the rule was an important new consumer law. An estimated 74.8 million Americans will be protected by the new medical loss ratio requirements, and up to 9 million Americans could be eligible for rebates in the first year, according to HHS.

Timothy Jost, a professor of law at Washington and Lee University, Lexington, Va., who advised the NAIC task force, said he estimated that insurers currently spend 12% of the premium dollar on pharmaceuticals and 31% for physician services, and 31% on administrative costs.

The rule "will drive insurers to become more efficient," and "incentivize them to not raise premiums more than necessary," Mr. Jost said during the briefing.

Perhaps in response to opponents who have complained that the passage of the ACA was a closed-door process, HHS and NAIC officials at the briefing said that the medical loss ratio rule had been developed in a very public fashion, with open hearings.

"These rules were carefully developed through a transparent and fair process with significant input from the public, the states, and other key stakeholders," said Jay Angoff, director of the HHS Office of Consumer Information and Insurance Oversight.

Jane Cline, president of the NAIC and insurance commissioner for West Virginia, said there were safeguards in the rule to ensure that it would not destabilize the insurance markets. The HHS Secretary will have the ability to adjust the medical loss ratio on a state-by-state basis to ensure that there is access to insurance, Ms. Cline said.

Four states – Maine, Iowa, South Carolina, and Georgia – have already asked HHS to change the requirements for insurers operating there; others could follow suit, Mr. Angoff said.

Transparency will be required of insurers as well. Starting in 2011 they will have to report publicly how they spend their premium dollars.

Beginning next year, health insurance companies will be required to prove that they spend at least 80% of premium dollars collected on direct medical care and quality improvement efforts under new federal regulations issued Nov. 22.

The interim final rule takes effect Jan. 1 and was required by the Affordable Care Act. The so-called medical loss ratio rule was developed by the National Association of Insurance Commissioners, which submitted its recommendations to the Health and Human Services department in late October.

According to the rule, HHS will review insurers’ medical loss data at the end of 2010. Companies that spend less than 80%-85% of their premium dollar on direct medical care will be required to issue rebates to consumers, said HHS Secretary Kathleen Sebelius at a press briefing. The rebate checks will begin arriving in 2012.

In some markets, insurers spend as little as 60% of the premium dollar on direct care, said Ms. Sebelius, who added that under the rule, those companies might have "to return nearly $3,500 to every family they insure." Her calculation was based on an average annual premium of $13,250 paid by a family of four.

Ms. Sebelius and other HHS officials said the rule was an important new consumer law. An estimated 74.8 million Americans will be protected by the new medical loss ratio requirements, and up to 9 million Americans could be eligible for rebates in the first year, according to HHS.

Timothy Jost, a professor of law at Washington and Lee University, Lexington, Va., who advised the NAIC task force, said he estimated that insurers currently spend 12% of the premium dollar on pharmaceuticals and 31% for physician services, and 31% on administrative costs.

The rule "will drive insurers to become more efficient," and "incentivize them to not raise premiums more than necessary," Mr. Jost said during the briefing.

Perhaps in response to opponents who have complained that the passage of the ACA was a closed-door process, HHS and NAIC officials at the briefing said that the medical loss ratio rule had been developed in a very public fashion, with open hearings.

"These rules were carefully developed through a transparent and fair process with significant input from the public, the states, and other key stakeholders," said Jay Angoff, director of the HHS Office of Consumer Information and Insurance Oversight.

Jane Cline, president of the NAIC and insurance commissioner for West Virginia, said there were safeguards in the rule to ensure that it would not destabilize the insurance markets. The HHS Secretary will have the ability to adjust the medical loss ratio on a state-by-state basis to ensure that there is access to insurance, Ms. Cline said.

Four states – Maine, Iowa, South Carolina, and Georgia – have already asked HHS to change the requirements for insurers operating there; others could follow suit, Mr. Angoff said.

Transparency will be required of insurers as well. Starting in 2011 they will have to report publicly how they spend their premium dollars.

Beginning next year, health insurance companies will be required to prove that they spend at least 80% of premium dollars collected on direct medical care and quality improvement efforts under new federal regulations issued Nov. 22.

The interim final rule takes effect Jan. 1 and was required by the Affordable Care Act. The so-called medical loss ratio rule was developed by the National Association of Insurance Commissioners, which submitted its recommendations to the Health and Human Services department in late October.

According to the rule, HHS will review insurers’ medical loss data at the end of 2010. Companies that spend less than 80%-85% of their premium dollar on direct medical care will be required to issue rebates to consumers, said HHS Secretary Kathleen Sebelius at a press briefing. The rebate checks will begin arriving in 2012.

In some markets, insurers spend as little as 60% of the premium dollar on direct care, said Ms. Sebelius, who added that under the rule, those companies might have "to return nearly $3,500 to every family they insure." Her calculation was based on an average annual premium of $13,250 paid by a family of four.

Ms. Sebelius and other HHS officials said the rule was an important new consumer law. An estimated 74.8 million Americans will be protected by the new medical loss ratio requirements, and up to 9 million Americans could be eligible for rebates in the first year, according to HHS.

Timothy Jost, a professor of law at Washington and Lee University, Lexington, Va., who advised the NAIC task force, said he estimated that insurers currently spend 12% of the premium dollar on pharmaceuticals and 31% for physician services, and 31% on administrative costs.

The rule "will drive insurers to become more efficient," and "incentivize them to not raise premiums more than necessary," Mr. Jost said during the briefing.

Perhaps in response to opponents who have complained that the passage of the ACA was a closed-door process, HHS and NAIC officials at the briefing said that the medical loss ratio rule had been developed in a very public fashion, with open hearings.

"These rules were carefully developed through a transparent and fair process with significant input from the public, the states, and other key stakeholders," said Jay Angoff, director of the HHS Office of Consumer Information and Insurance Oversight.

Jane Cline, president of the NAIC and insurance commissioner for West Virginia, said there were safeguards in the rule to ensure that it would not destabilize the insurance markets. The HHS Secretary will have the ability to adjust the medical loss ratio on a state-by-state basis to ensure that there is access to insurance, Ms. Cline said.

Four states – Maine, Iowa, South Carolina, and Georgia – have already asked HHS to change the requirements for insurers operating there; others could follow suit, Mr. Angoff said.

Transparency will be required of insurers as well. Starting in 2011 they will have to report publicly how they spend their premium dollars.

Beginning next year, health insurance companies will be required to prove that they spend at least 80% of premium dollars collected on direct medical care and quality improvement efforts under new federal regulations issued Nov. 22.

The interim final rule takes effect Jan. 1 and was required by the Affordable Care Act. The so-called medical loss ratio rule was developed by the National Association of Insurance Commissioners, which submitted its recommendations to the Health and Human Services department in late October.

According to the rule, HHS will review insurers’ medical loss data at the end of 2010. Companies that spend less than 80%-85% of their premium dollar on direct medical care will be required to issue rebates to consumers, said HHS Secretary Kathleen Sebelius at a press briefing. The rebate checks will begin arriving in 2012.

In some markets, insurers spend as little as 60% of the premium dollar on direct care, said Ms. Sebelius, who added that under the rule, those companies might have "to return nearly $3,500 to every family they insure." Her calculation was based on an average annual premium of $13,250 paid by a family of four.

Ms. Sebelius and other HHS officials said the rule was an important new consumer law. An estimated 74.8 million Americans will be protected by the new medical loss ratio requirements, and up to 9 million Americans could be eligible for rebates in the first year, according to HHS.

Timothy Jost, a professor of law at Washington and Lee University, Lexington, Va., who advised the NAIC task force, said he estimated that insurers currently spend 12% of the premium dollar on pharmaceuticals and 31% for physician services, and 31% on administrative costs.

The rule "will drive insurers to become more efficient," and "incentivize them to not raise premiums more than necessary," Mr. Jost said during the briefing.

Perhaps in response to opponents who have complained that the passage of the ACA was a closed-door process, HHS and NAIC officials at the briefing said that the medical loss ratio rule had been developed in a very public fashion, with open hearings.

"These rules were carefully developed through a transparent and fair process with significant input from the public, the states, and other key stakeholders," said Jay Angoff, director of the HHS Office of Consumer Information and Insurance Oversight.

Jane Cline, president of the NAIC and insurance commissioner for West Virginia, said there were safeguards in the rule to ensure that it would not destabilize the insurance markets. The HHS Secretary will have the ability to adjust the medical loss ratio on a state-by-state basis to ensure that there is access to insurance, Ms. Cline said.

Four states – Maine, Iowa, South Carolina, and Georgia – have already asked HHS to change the requirements for insurers operating there; others could follow suit, Mr. Angoff said.

Transparency will be required of insurers as well. Starting in 2011 they will have to report publicly how they spend their premium dollars.

The United States Senate on Nov. 18 approved a 1-month extension of current Medicare physician fee rates, moving Congress one step closer to avoiding the statutory 23% reduction that is due to go into effect Dec. 1.

The Physician Payment and Therapy Relief Act of 2010 was introduced in the Senate by Finance Committee Chairman Max Baucus (D-Mont.) and ranking minority member Chuck Grassley (R-Iowa). It was originally introduced in the House in July by Rep. Sander Levin (D-Mich.) and was agreed to by voice vote that month. But the Senate amended the bill Nov. 18, which means it has to go back to the House for approval.

The American College of Physicians expects the House, which has gone out on recess for the Thanksgiving holiday, to take up the bill Nov. 29 or 30, according to a spokesman for the physician organization.

The estimated cost for the 1-month extension: $1 billion over 10 years. The Senate would pay for that by using savings from a new Centers for Medicare and Medicaid Services policy that reduces Medicare payments for multiple therapy services provided to patients in 1 day. Therapists would not be squeezed, however; the proposal would also shrink the called-for reduction from 25% to 20%, according to Sens. Baucus and Grassley.

"Seniors and military families can rest assured that they will continue to have access to the doctors, treatments, and medications they need," said Sen. Baucus in a statement. "Once signed into law by the president, it will mean that seniors and military families are spared the threat of a lapse in care. The next step is moving on to finding a yearlong extension before this fix runs out."

The United States Senate on Nov. 18 approved a 1-month extension of current Medicare physician fee rates, moving Congress one step closer to avoiding the statutory 23% reduction that is due to go into effect Dec. 1.

The Physician Payment and Therapy Relief Act of 2010 was introduced in the Senate by Finance Committee Chairman Max Baucus (D-Mont.) and ranking minority member Chuck Grassley (R-Iowa). It was originally introduced in the House in July by Rep. Sander Levin (D-Mich.) and was agreed to by voice vote that month. But the Senate amended the bill Nov. 18, which means it has to go back to the House for approval.

The American College of Physicians expects the House, which has gone out on recess for the Thanksgiving holiday, to take up the bill Nov. 29 or 30, according to a spokesman for the physician organization.

The estimated cost for the 1-month extension: $1 billion over 10 years. The Senate would pay for that by using savings from a new Centers for Medicare and Medicaid Services policy that reduces Medicare payments for multiple therapy services provided to patients in 1 day. Therapists would not be squeezed, however; the proposal would also shrink the called-for reduction from 25% to 20%, according to Sens. Baucus and Grassley.

"Seniors and military families can rest assured that they will continue to have access to the doctors, treatments, and medications they need," said Sen. Baucus in a statement. "Once signed into law by the president, it will mean that seniors and military families are spared the threat of a lapse in care. The next step is moving on to finding a yearlong extension before this fix runs out."

The United States Senate on Nov. 18 approved a 1-month extension of current Medicare physician fee rates, moving Congress one step closer to avoiding the statutory 23% reduction that is due to go into effect Dec. 1.

The Physician Payment and Therapy Relief Act of 2010 was introduced in the Senate by Finance Committee Chairman Max Baucus (D-Mont.) and ranking minority member Chuck Grassley (R-Iowa). It was originally introduced in the House in July by Rep. Sander Levin (D-Mich.) and was agreed to by voice vote that month. But the Senate amended the bill Nov. 18, which means it has to go back to the House for approval.

The American College of Physicians expects the House, which has gone out on recess for the Thanksgiving holiday, to take up the bill Nov. 29 or 30, according to a spokesman for the physician organization.

The estimated cost for the 1-month extension: $1 billion over 10 years. The Senate would pay for that by using savings from a new Centers for Medicare and Medicaid Services policy that reduces Medicare payments for multiple therapy services provided to patients in 1 day. Therapists would not be squeezed, however; the proposal would also shrink the called-for reduction from 25% to 20%, according to Sens. Baucus and Grassley.

"Seniors and military families can rest assured that they will continue to have access to the doctors, treatments, and medications they need," said Sen. Baucus in a statement. "Once signed into law by the president, it will mean that seniors and military families are spared the threat of a lapse in care. The next step is moving on to finding a yearlong extension before this fix runs out."

The Food and Drug Administration on Nov. 18 approved the monoclonal antibody denosumab (Xgeva) for the prevention of skeletal-related events in patients with bone metastases from solid tumors.

Denosumab maker Amgen made the announcement, which was expected since the agency was required to make a decision on the indication by Nov. 18. The drug was given a 6-month priority review, indicating that it was considered a major advance in treatment.

“Xgeva has a different mechanism of action than currently approved drugs aimed at reducing bone complications from cancer,” Dr. Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, said in a written statement on the approval.

A fully human monoclonal antibody with a unique mechanism of action, denosumab specifically targets the receptor activator of the nuclear factor kappa-B (RANK) ligand, the essential mediator of osteoclast fusion. The drug inhibits osteoclast formation, function, and survival, resulting in reduced bone resorption. The RANK ligand pathway was discovered by Amgen scientists in the mid-1990s, according to the company.

According to Amgen, bone metastases occur in 1.5 million cancer patients worldwide. They are most commonly seen in prostate, lung, and breast cancer. Denosumab was not approved for bone metastases related to multiple myeloma.

“A diagnosis of bone metastases is a major event for patients living with cancer, and the consequences can be devastating,” Amgen chairman and CEO Kevin Sharer said in a written statement. “We are pleased to offer this new advance to patients and their health care providers.”

The approval of denosumab was based on three phase III head-to-head trials comprising 5,700 patients that compared the drug with zoledronic acid (Zometa). The drug was superior to zoledronic acid in preventing skeletal-related events (SRE) in breast and prostate cancer. Some of that data was presented in June at the annual meeting of the American Society of Clinical Oncology. Denosumab was noninferior in preventing SREs in multiple myeloma and other solid tumors.

Adverse effects include hypocalcemia, fatigue, hypophosphatemia, and nausea. Osteonecrosis of the jaw can also occur.

The drug is given by subcutaneous injection once every 4 weeks. *

Because of the drug’s expense, Amgen is launching a new patient assistance program. The Xgeva First Step Coupon Program will provide assistance to eligible patients who need help meeting a deductible, copayment, or coinsurance. The first injection would be covered and subsequent injections would cost a maximum of $25.

Denosumab was approved in June to treat postmenopausal women with osteoporosis who are at high risk for fracture.

* CORRECTION, 11/19/2010: The original version of this article misstated the dosage frequency of denosumab (Xgeva). It is administered every 4 weeks as a subcutaneous injection. This version has been updated.

The Food and Drug Administration on Nov. 18 approved the monoclonal antibody denosumab (Xgeva) for the prevention of skeletal-related events in patients with bone metastases from solid tumors.

Denosumab maker Amgen made the announcement, which was expected since the agency was required to make a decision on the indication by Nov. 18. The drug was given a 6-month priority review, indicating that it was considered a major advance in treatment.

“Xgeva has a different mechanism of action than currently approved drugs aimed at reducing bone complications from cancer,” Dr. Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, said in a written statement on the approval.

A fully human monoclonal antibody with a unique mechanism of action, denosumab specifically targets the receptor activator of the nuclear factor kappa-B (RANK) ligand, the essential mediator of osteoclast fusion. The drug inhibits osteoclast formation, function, and survival, resulting in reduced bone resorption. The RANK ligand pathway was discovered by Amgen scientists in the mid-1990s, according to the company.

According to Amgen, bone metastases occur in 1.5 million cancer patients worldwide. They are most commonly seen in prostate, lung, and breast cancer. Denosumab was not approved for bone metastases related to multiple myeloma.

“A diagnosis of bone metastases is a major event for patients living with cancer, and the consequences can be devastating,” Amgen chairman and CEO Kevin Sharer said in a written statement. “We are pleased to offer this new advance to patients and their health care providers.”

The approval of denosumab was based on three phase III head-to-head trials comprising 5,700 patients that compared the drug with zoledronic acid (Zometa). The drug was superior to zoledronic acid in preventing skeletal-related events (SRE) in breast and prostate cancer. Some of that data was presented in June at the annual meeting of the American Society of Clinical Oncology. Denosumab was noninferior in preventing SREs in multiple myeloma and other solid tumors.

Adverse effects include hypocalcemia, fatigue, hypophosphatemia, and nausea. Osteonecrosis of the jaw can also occur.

The drug is given by subcutaneous injection once every 4 weeks. *

Because of the drug’s expense, Amgen is launching a new patient assistance program. The Xgeva First Step Coupon Program will provide assistance to eligible patients who need help meeting a deductible, copayment, or coinsurance. The first injection would be covered and subsequent injections would cost a maximum of $25.

Denosumab was approved in June to treat postmenopausal women with osteoporosis who are at high risk for fracture.

* CORRECTION, 11/19/2010: The original version of this article misstated the dosage frequency of denosumab (Xgeva). It is administered every 4 weeks as a subcutaneous injection. This version has been updated.

The Food and Drug Administration on Nov. 18 approved the monoclonal antibody denosumab (Xgeva) for the prevention of skeletal-related events in patients with bone metastases from solid tumors.

Denosumab maker Amgen made the announcement, which was expected since the agency was required to make a decision on the indication by Nov. 18. The drug was given a 6-month priority review, indicating that it was considered a major advance in treatment.

“Xgeva has a different mechanism of action than currently approved drugs aimed at reducing bone complications from cancer,” Dr. Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, said in a written statement on the approval.

A fully human monoclonal antibody with a unique mechanism of action, denosumab specifically targets the receptor activator of the nuclear factor kappa-B (RANK) ligand, the essential mediator of osteoclast fusion. The drug inhibits osteoclast formation, function, and survival, resulting in reduced bone resorption. The RANK ligand pathway was discovered by Amgen scientists in the mid-1990s, according to the company.

According to Amgen, bone metastases occur in 1.5 million cancer patients worldwide. They are most commonly seen in prostate, lung, and breast cancer. Denosumab was not approved for bone metastases related to multiple myeloma.

“A diagnosis of bone metastases is a major event for patients living with cancer, and the consequences can be devastating,” Amgen chairman and CEO Kevin Sharer said in a written statement. “We are pleased to offer this new advance to patients and their health care providers.”

The approval of denosumab was based on three phase III head-to-head trials comprising 5,700 patients that compared the drug with zoledronic acid (Zometa). The drug was superior to zoledronic acid in preventing skeletal-related events (SRE) in breast and prostate cancer. Some of that data was presented in June at the annual meeting of the American Society of Clinical Oncology. Denosumab was noninferior in preventing SREs in multiple myeloma and other solid tumors.

Adverse effects include hypocalcemia, fatigue, hypophosphatemia, and nausea. Osteonecrosis of the jaw can also occur.

The drug is given by subcutaneous injection once every 4 weeks. *

Because of the drug’s expense, Amgen is launching a new patient assistance program. The Xgeva First Step Coupon Program will provide assistance to eligible patients who need help meeting a deductible, copayment, or coinsurance. The first injection would be covered and subsequent injections would cost a maximum of $25.

Denosumab was approved in June to treat postmenopausal women with osteoporosis who are at high risk for fracture.

* CORRECTION, 11/19/2010: The original version of this article misstated the dosage frequency of denosumab (Xgeva). It is administered every 4 weeks as a subcutaneous injection. This version has been updated.

The United States Senate on Nov. 18 approved a 1-month extension of current Medicare physician fee rates, moving Congress one step closer to avoiding the statutory 23% reduction that is due to go into effect Dec. 1.

The Physician Payment and Therapy Relief Act of 2010 was introduced in the Senate by Finance Committee Chairman Max Baucus (D-Mont.) and ranking minority member Chuck Grassley (R-Iowa). It was originally introduced in the House in July by Rep. Sander Levin (D-Mich.) and was agreed to by voice vote that month. But the Senate amended the bill Nov. 18, which means it has to go back to the House for approval.

The American College of Physicians expects the House, which has gone out on recess for the Thanksgiving holiday, to take up the bill Nov. 29 or 30, according to a spokesman for the physician organization.

The estimated cost for the 1-month extension: $1 billion over 10 years. The Senate would pay for that by using savings from a new Centers for Medicare and Medicaid Services policy that reduces Medicare payments for multiple therapy services provided to patients in 1 day. Therapists would not be squeezed, however; the proposal would also shrink the called-for reduction from 25% to 20%, according to Sens. Baucus and Grassley.

"Seniors and military families can rest assured that they will continue to have access to the doctors, treatments, and medications they need," said Sen. Baucus in a statement. "Once signed into law by the president, it will mean that seniors and military families are spared the threat of a lapse in care. The next step is moving on to finding a yearlong extension before this fix runs out."

The United States Senate on Nov. 18 approved a 1-month extension of current Medicare physician fee rates, moving Congress one step closer to avoiding the statutory 23% reduction that is due to go into effect Dec. 1.

The Physician Payment and Therapy Relief Act of 2010 was introduced in the Senate by Finance Committee Chairman Max Baucus (D-Mont.) and ranking minority member Chuck Grassley (R-Iowa). It was originally introduced in the House in July by Rep. Sander Levin (D-Mich.) and was agreed to by voice vote that month. But the Senate amended the bill Nov. 18, which means it has to go back to the House for approval.

The American College of Physicians expects the House, which has gone out on recess for the Thanksgiving holiday, to take up the bill Nov. 29 or 30, according to a spokesman for the physician organization.

The estimated cost for the 1-month extension: $1 billion over 10 years. The Senate would pay for that by using savings from a new Centers for Medicare and Medicaid Services policy that reduces Medicare payments for multiple therapy services provided to patients in 1 day. Therapists would not be squeezed, however; the proposal would also shrink the called-for reduction from 25% to 20%, according to Sens. Baucus and Grassley.

"Seniors and military families can rest assured that they will continue to have access to the doctors, treatments, and medications they need," said Sen. Baucus in a statement. "Once signed into law by the president, it will mean that seniors and military families are spared the threat of a lapse in care. The next step is moving on to finding a yearlong extension before this fix runs out."

The United States Senate on Nov. 18 approved a 1-month extension of current Medicare physician fee rates, moving Congress one step closer to avoiding the statutory 23% reduction that is due to go into effect Dec. 1.

The Physician Payment and Therapy Relief Act of 2010 was introduced in the Senate by Finance Committee Chairman Max Baucus (D-Mont.) and ranking minority member Chuck Grassley (R-Iowa). It was originally introduced in the House in July by Rep. Sander Levin (D-Mich.) and was agreed to by voice vote that month. But the Senate amended the bill Nov. 18, which means it has to go back to the House for approval.

The American College of Physicians expects the House, which has gone out on recess for the Thanksgiving holiday, to take up the bill Nov. 29 or 30, according to a spokesman for the physician organization.

The estimated cost for the 1-month extension: $1 billion over 10 years. The Senate would pay for that by using savings from a new Centers for Medicare and Medicaid Services policy that reduces Medicare payments for multiple therapy services provided to patients in 1 day. Therapists would not be squeezed, however; the proposal would also shrink the called-for reduction from 25% to 20%, according to Sens. Baucus and Grassley.

"Seniors and military families can rest assured that they will continue to have access to the doctors, treatments, and medications they need," said Sen. Baucus in a statement. "Once signed into law by the president, it will mean that seniors and military families are spared the threat of a lapse in care. The next step is moving on to finding a yearlong extension before this fix runs out."

The United States Senate on Nov. 18 approved a 1-month extension of current Medicare physician fee rates, moving Congress one step closer to avoiding the statutory 23% reduction that is due to go into effect Dec. 1.

The Physician Payment and Therapy Relief Act of 2010 was introduced in the Senate by Finance Committee Chairman Max Baucus (D-Mont.) and ranking minority member Chuck Grassley (R-Iowa). It was originally introduced in the House in July by Rep. Sander Levin (D-Mich.) and was agreed to by voice vote that month. But the Senate amended the bill Nov. 18, which means it has to go back to the House for approval.

The American College of Physicians expects the House, which has gone out on recess for the Thanksgiving holiday, to take up the bill Nov. 29 or 30, according to a spokesman for the physician organization.

The estimated cost for the 1-month extension: $1 billion over 10 years. The Senate would pay for that by using savings from a new Centers for Medicare and Medicaid Services policy that reduces Medicare payments for multiple therapy services provided to patients in 1 day. Therapists would not be squeezed, however; the proposal would also shrink the called-for reduction from 25% to 20%, according to Sens. Baucus and Grassley.

"Seniors and military families can rest assured that they will continue to have access to the doctors, treatments, and medications they need," said Sen. Baucus in a statement. "Once signed into law by the president, it will mean that seniors and military families are spared the threat of a lapse in care. The next step is moving on to finding a yearlong extension before this fix runs out."

The United States Senate on Nov. 18 approved a 1-month extension of current Medicare physician fee rates, moving Congress one step closer to avoiding the statutory 23% reduction that is due to go into effect Dec. 1.

The Physician Payment and Therapy Relief Act of 2010 was introduced in the Senate by Finance Committee Chairman Max Baucus (D-Mont.) and ranking minority member Chuck Grassley (R-Iowa). It was originally introduced in the House in July by Rep. Sander Levin (D-Mich.) and was agreed to by voice vote that month. But the Senate amended the bill Nov. 18, which means it has to go back to the House for approval.

The American College of Physicians expects the House, which has gone out on recess for the Thanksgiving holiday, to take up the bill Nov. 29 or 30, according to a spokesman for the physician organization.

The estimated cost for the 1-month extension: $1 billion over 10 years. The Senate would pay for that by using savings from a new Centers for Medicare and Medicaid Services policy that reduces Medicare payments for multiple therapy services provided to patients in 1 day. Therapists would not be squeezed, however; the proposal would also shrink the called-for reduction from 25% to 20%, according to Sens. Baucus and Grassley.

"Seniors and military families can rest assured that they will continue to have access to the doctors, treatments, and medications they need," said Sen. Baucus in a statement. "Once signed into law by the president, it will mean that seniors and military families are spared the threat of a lapse in care. The next step is moving on to finding a yearlong extension before this fix runs out."

The United States Senate on Nov. 18 approved a 1-month extension of current Medicare physician fee rates, moving Congress one step closer to avoiding the statutory 23% reduction that is due to go into effect Dec. 1.

The Physician Payment and Therapy Relief Act of 2010 was introduced in the Senate by Finance Committee Chairman Max Baucus (D-Mont.) and ranking minority member Chuck Grassley (R-Iowa). It was originally introduced in the House in July by Rep. Sander Levin (D-Mich.) and was agreed to by voice vote that month. But the Senate amended the bill Nov. 18, which means it has to go back to the House for approval.

The American College of Physicians expects the House, which has gone out on recess for the Thanksgiving holiday, to take up the bill Nov. 29 or 30, according to a spokesman for the physician organization.

The estimated cost for the 1-month extension: $1 billion over 10 years. The Senate would pay for that by using savings from a new Centers for Medicare and Medicaid Services policy that reduces Medicare payments for multiple therapy services provided to patients in 1 day. Therapists would not be squeezed, however; the proposal would also shrink the called-for reduction from 25% to 20%, according to Sens. Baucus and Grassley.

"Seniors and military families can rest assured that they will continue to have access to the doctors, treatments, and medications they need," said Sen. Baucus in a statement. "Once signed into law by the president, it will mean that seniors and military families are spared the threat of a lapse in care. The next step is moving on to finding a yearlong extension before this fix runs out."

Washington – Dr. Don Berwick, administrator of the Centers for Medicare and Medicaid Services, largely escaped criticism from the Republican senators during his first official appearance on Capitol Hill on Nov. 17, but several senators vowed that they would ensure that he answered all their questions in writing or at another hearing.

Dr. Berwick was appointed by President Obama in July while Congress was in recess. Thus, Dr. Berwick was never subject to confirmation hearings, leaving most Republicans and some Democrats saying that the legislative authority to confirm high-level executive branch appointments had been bypassed.

Speaking before the Finance committee on Nov. 17, Dr. Berwick tried to soothe his potential critics by discussing the potential he sees in addressing the wrongs of the American health care system.

"I feel incredibly lucky to be able to join CMS at a historic time, a time of enormous promise for the future of our nation’s health care," he said. He added that he felt that the federal government "should aim for three goals simultaneously: better care for individuals, better health for the American people, and lower costs through improvement."

The Affordable Care Act (ACA) is "the best opportunity we’ve had in a generation or more to make progress," said Dr. Berwick.

The hearing was led by Chairman Max Baucus (D-Mont.), who scheduled 1 hour for opening statements, testimony, and questioning – an unusually short duration for any congressional committee hearing.

Democratic members of the panel used their allotted 5 minutes of questioning to express enthusiasm for various parts of the ACA and to give Dr. Berwick the opportunity to do the same. Republicans mainly expressed concern that they did not have the ability to properly question Dr. Berwick, given the hearing’s tight timeline.

During his turn to question the CMS administrator, the committee’s ranking minority member, Sen. Chuck Grassley (R-Iowa), wanted to know whether Dr. Berwick supported the conclusions of an April report by Rick Foster, the Medicare Chief Actuary. According to Sen. Grassley, that report said that the reductions envisioned in the ACA would threaten beneficiaries’ access to care.

Dr. Berwick countered that Mr. Foster’s estimates were just that – estimates based on his best judgement.

"Our intention is to increase access to care," he told Sen. Grassley. He added that beneficiaries will "find themselves in better shape after implementation of this act is fully engaged."

Sen. Orrin Hatch (R-Utah) also queried Dr. Berwick about the actuary’s report. But he used most of his time to complain that the CMS Administrator – in charge of a budget that is larger than the Pentagon’s, as he noted – had not been available until that day.

"Obviously, asking us to cover all of our concerns in this hour-long hearing with only 5 minutes...per person, is like asking us to drain the Pacific Ocean with a thimble," Sen. Hatch said.

He said that he hoped that Dr. Berwick would answer any and all questions put to him in writing and that the Administration would allow him to fully answer the queries.

Sen. Hatch and Sen. Grassley and other Republicans asked for additional hearings with Dr. Berwick after the Thanksgiving break, but Chairman Baucus was noncommittal about scheduling such an event.

That prompted a blunt assessment from Sen. Jim Bunning (R-Ky.), who is not returning for the next Congress.

"I can assure you that you will not get special treatment next year," when Republicans hold the majority in the House. "I suspect that you will be spending a lot of time testifying before the House of Representatives, partly because we in the Senate have been shut out," Sen. Bunning said

Washington – Dr. Don Berwick, administrator of the Centers for Medicare and Medicaid Services, largely escaped criticism from the Republican senators during his first official appearance on Capitol Hill on Nov. 17, but several senators vowed that they would ensure that he answered all their questions in writing or at another hearing.

Dr. Berwick was appointed by President Obama in July while Congress was in recess. Thus, Dr. Berwick was never subject to confirmation hearings, leaving most Republicans and some Democrats saying that the legislative authority to confirm high-level executive branch appointments had been bypassed.

Speaking before the Finance committee on Nov. 17, Dr. Berwick tried to soothe his potential critics by discussing the potential he sees in addressing the wrongs of the American health care system.

"I feel incredibly lucky to be able to join CMS at a historic time, a time of enormous promise for the future of our nation’s health care," he said. He added that he felt that the federal government "should aim for three goals simultaneously: better care for individuals, better health for the American people, and lower costs through improvement."

The Affordable Care Act (ACA) is "the best opportunity we’ve had in a generation or more to make progress," said Dr. Berwick.

The hearing was led by Chairman Max Baucus (D-Mont.), who scheduled 1 hour for opening statements, testimony, and questioning – an unusually short duration for any congressional committee hearing.

Democratic members of the panel used their allotted 5 minutes of questioning to express enthusiasm for various parts of the ACA and to give Dr. Berwick the opportunity to do the same. Republicans mainly expressed concern that they did not have the ability to properly question Dr. Berwick, given the hearing’s tight timeline.

During his turn to question the CMS administrator, the committee’s ranking minority member, Sen. Chuck Grassley (R-Iowa), wanted to know whether Dr. Berwick supported the conclusions of an April report by Rick Foster, the Medicare Chief Actuary. According to Sen. Grassley, that report said that the reductions envisioned in the ACA would threaten beneficiaries’ access to care.

Dr. Berwick countered that Mr. Foster’s estimates were just that – estimates based on his best judgement.

"Our intention is to increase access to care," he told Sen. Grassley. He added that beneficiaries will "find themselves in better shape after implementation of this act is fully engaged."

Sen. Orrin Hatch (R-Utah) also queried Dr. Berwick about the actuary’s report. But he used most of his time to complain that the CMS Administrator – in charge of a budget that is larger than the Pentagon’s, as he noted – had not been available until that day.

"Obviously, asking us to cover all of our concerns in this hour-long hearing with only 5 minutes...per person, is like asking us to drain the Pacific Ocean with a thimble," Sen. Hatch said.

He said that he hoped that Dr. Berwick would answer any and all questions put to him in writing and that the Administration would allow him to fully answer the queries.

Sen. Hatch and Sen. Grassley and other Republicans asked for additional hearings with Dr. Berwick after the Thanksgiving break, but Chairman Baucus was noncommittal about scheduling such an event.

That prompted a blunt assessment from Sen. Jim Bunning (R-Ky.), who is not returning for the next Congress.

"I can assure you that you will not get special treatment next year," when Republicans hold the majority in the House. "I suspect that you will be spending a lot of time testifying before the House of Representatives, partly because we in the Senate have been shut out," Sen. Bunning said

Washington – Dr. Don Berwick, administrator of the Centers for Medicare and Medicaid Services, largely escaped criticism from the Republican senators during his first official appearance on Capitol Hill on Nov. 17, but several senators vowed that they would ensure that he answered all their questions in writing or at another hearing.

Dr. Berwick was appointed by President Obama in July while Congress was in recess. Thus, Dr. Berwick was never subject to confirmation hearings, leaving most Republicans and some Democrats saying that the legislative authority to confirm high-level executive branch appointments had been bypassed.

Speaking before the Finance committee on Nov. 17, Dr. Berwick tried to soothe his potential critics by discussing the potential he sees in addressing the wrongs of the American health care system.

"I feel incredibly lucky to be able to join CMS at a historic time, a time of enormous promise for the future of our nation’s health care," he said. He added that he felt that the federal government "should aim for three goals simultaneously: better care for individuals, better health for the American people, and lower costs through improvement."

The Affordable Care Act (ACA) is "the best opportunity we’ve had in a generation or more to make progress," said Dr. Berwick.

The hearing was led by Chairman Max Baucus (D-Mont.), who scheduled 1 hour for opening statements, testimony, and questioning – an unusually short duration for any congressional committee hearing.

Democratic members of the panel used their allotted 5 minutes of questioning to express enthusiasm for various parts of the ACA and to give Dr. Berwick the opportunity to do the same. Republicans mainly expressed concern that they did not have the ability to properly question Dr. Berwick, given the hearing’s tight timeline.

During his turn to question the CMS administrator, the committee’s ranking minority member, Sen. Chuck Grassley (R-Iowa), wanted to know whether Dr. Berwick supported the conclusions of an April report by Rick Foster, the Medicare Chief Actuary. According to Sen. Grassley, that report said that the reductions envisioned in the ACA would threaten beneficiaries’ access to care.

Dr. Berwick countered that Mr. Foster’s estimates were just that – estimates based on his best judgement.

"Our intention is to increase access to care," he told Sen. Grassley. He added that beneficiaries will "find themselves in better shape after implementation of this act is fully engaged."

Sen. Orrin Hatch (R-Utah) also queried Dr. Berwick about the actuary’s report. But he used most of his time to complain that the CMS Administrator – in charge of a budget that is larger than the Pentagon’s, as he noted – had not been available until that day.

"Obviously, asking us to cover all of our concerns in this hour-long hearing with only 5 minutes...per person, is like asking us to drain the Pacific Ocean with a thimble," Sen. Hatch said.

He said that he hoped that Dr. Berwick would answer any and all questions put to him in writing and that the Administration would allow him to fully answer the queries.

Sen. Hatch and Sen. Grassley and other Republicans asked for additional hearings with Dr. Berwick after the Thanksgiving break, but Chairman Baucus was noncommittal about scheduling such an event.

That prompted a blunt assessment from Sen. Jim Bunning (R-Ky.), who is not returning for the next Congress.

"I can assure you that you will not get special treatment next year," when Republicans hold the majority in the House. "I suspect that you will be spending a lot of time testifying before the House of Representatives, partly because we in the Senate have been shut out," Sen. Bunning said

WASHINGTON – Dr. Don Berwick, administrator of the Centers for Medicare and Medicaid Services, largely escaped criticism from the Republican senators during his first official appearance on Capitol Hill on Nov. 17, but several senators vowed that they would ensure that he answered all their questions in writing or at another hearing.

Dr. Berwick was appointed by President Obama in July while Congress was in recess. Thus, Dr. Berwick was never subject to confirmation hearings, leaving most Republicans and some Democrats saying that the legislative authority to confirm high-level executive branch appointments had been bypassed.

Speaking before the Finance committee on Nov. 17, Dr. Berwick tried to soothe his potential critics by discussing the potential he sees in addressing the wrongs of the American health care system.

"I feel incredibly lucky to be able to join CMS at a historic time, a time of enormous promise for the future of our nation’s health care," he said. He added that he felt that the federal government "should aim for three goals simultaneously: better care for individuals, better health for the American people, and lower costs through improvement."

The Affordable Care Act (ACA) is "the best opportunity we’ve had in a generation or more to make progress," said Dr. Berwick.

The hearing was led by Chairman Max Baucus (D-Mont.), who scheduled 1 hour for opening statements, testimony, and questioning – an unusually short duration for any congressional committee hearing.

Democratic members of the panel used their allotted 5 minutes of questioning to express enthusiasm for various parts of the ACA and to give Dr. Berwick the opportunity to do the same. Republicans mainly expressed concern that they did not have the ability to properly question Dr. Berwick, given the hearing’s tight timeline.

During his turn to question the CMS administrator, the committee’s ranking minority member, Sen. Chuck Grassley (R-Iowa), wanted to know whether Dr. Berwick supported the conclusions of an April report by Rick Foster, the Medicare Chief Actuary. According to Sen. Grassley, that report said that the reductions envisioned in the ACA would threaten beneficiaries’ access to care.

Dr. Berwick countered that Mr. Foster’s estimates were just that – estimates based on his best judgement.

"Our intention is to increase access to care," he told Sen. Grassley. He added that beneficiaries will "find themselves in better shape after implementation of this act is fully engaged."

Sen. Orrin Hatch (R-Utah) also queried Dr. Berwick about the actuary’s report. But he used most of his time to complain that the CMS Administrator – in charge of a budget that is larger than the Pentagon’s, as he noted – had not been available until that day.

"Obviously, asking us to cover all of our concerns in this hour-long hearing with only 5 minutes...per person, is like asking us to drain the Pacific Ocean with a thimble," Sen. Hatch said.

He said that he hoped that Dr. Berwick would answer any and all questions put to him in writing and that the Administration would allow him to fully answer the queries.

Sen. Hatch and Sen. Grassley and other Republicans asked for additional hearings with Dr. Berwick after the Thanksgiving break, but Chairman Baucus was noncommittal about scheduling such an event.

That prompted a blunt assessment from Sen. Jim Bunning (R-Ky.), who is not returning for the next Congress.

"I can assure you that you will not get special treatment next year," when Republicans hold the majority in the House. "I suspect that you will be spending a lot of time testifying before the House of Representatives, partly because we in the Senate have been shut out," Sen. Bunning said.

WASHINGTON – Dr. Don Berwick, administrator of the Centers for Medicare and Medicaid Services, largely escaped criticism from the Republican senators during his first official appearance on Capitol Hill on Nov. 17, but several senators vowed that they would ensure that he answered all their questions in writing or at another hearing.

Dr. Berwick was appointed by President Obama in July while Congress was in recess. Thus, Dr. Berwick was never subject to confirmation hearings, leaving most Republicans and some Democrats saying that the legislative authority to confirm high-level executive branch appointments had been bypassed.

Speaking before the Finance committee on Nov. 17, Dr. Berwick tried to soothe his potential critics by discussing the potential he sees in addressing the wrongs of the American health care system.

"I feel incredibly lucky to be able to join CMS at a historic time, a time of enormous promise for the future of our nation’s health care," he said. He added that he felt that the federal government "should aim for three goals simultaneously: better care for individuals, better health for the American people, and lower costs through improvement."

The Affordable Care Act (ACA) is "the best opportunity we’ve had in a generation or more to make progress," said Dr. Berwick.

The hearing was led by Chairman Max Baucus (D-Mont.), who scheduled 1 hour for opening statements, testimony, and questioning – an unusually short duration for any congressional committee hearing.

Democratic members of the panel used their allotted 5 minutes of questioning to express enthusiasm for various parts of the ACA and to give Dr. Berwick the opportunity to do the same. Republicans mainly expressed concern that they did not have the ability to properly question Dr. Berwick, given the hearing’s tight timeline.

During his turn to question the CMS administrator, the committee’s ranking minority member, Sen. Chuck Grassley (R-Iowa), wanted to know whether Dr. Berwick supported the conclusions of an April report by Rick Foster, the Medicare Chief Actuary. According to Sen. Grassley, that report said that the reductions envisioned in the ACA would threaten beneficiaries’ access to care.

Dr. Berwick countered that Mr. Foster’s estimates were just that – estimates based on his best judgement.

"Our intention is to increase access to care," he told Sen. Grassley. He added that beneficiaries will "find themselves in better shape after implementation of this act is fully engaged."

Sen. Orrin Hatch (R-Utah) also queried Dr. Berwick about the actuary’s report. But he used most of his time to complain that the CMS Administrator – in charge of a budget that is larger than the Pentagon’s, as he noted – had not been available until that day.

"Obviously, asking us to cover all of our concerns in this hour-long hearing with only 5 minutes...per person, is like asking us to drain the Pacific Ocean with a thimble," Sen. Hatch said.

He said that he hoped that Dr. Berwick would answer any and all questions put to him in writing and that the Administration would allow him to fully answer the queries.

Sen. Hatch and Sen. Grassley and other Republicans asked for additional hearings with Dr. Berwick after the Thanksgiving break, but Chairman Baucus was noncommittal about scheduling such an event.

That prompted a blunt assessment from Sen. Jim Bunning (R-Ky.), who is not returning for the next Congress.

"I can assure you that you will not get special treatment next year," when Republicans hold the majority in the House. "I suspect that you will be spending a lot of time testifying before the House of Representatives, partly because we in the Senate have been shut out," Sen. Bunning said.

WASHINGTON – Dr. Don Berwick, administrator of the Centers for Medicare and Medicaid Services, largely escaped criticism from the Republican senators during his first official appearance on Capitol Hill on Nov. 17, but several senators vowed that they would ensure that he answered all their questions in writing or at another hearing.

Dr. Berwick was appointed by President Obama in July while Congress was in recess. Thus, Dr. Berwick was never subject to confirmation hearings, leaving most Republicans and some Democrats saying that the legislative authority to confirm high-level executive branch appointments had been bypassed.

Speaking before the Finance committee on Nov. 17, Dr. Berwick tried to soothe his potential critics by discussing the potential he sees in addressing the wrongs of the American health care system.

"I feel incredibly lucky to be able to join CMS at a historic time, a time of enormous promise for the future of our nation’s health care," he said. He added that he felt that the federal government "should aim for three goals simultaneously: better care for individuals, better health for the American people, and lower costs through improvement."

The Affordable Care Act (ACA) is "the best opportunity we’ve had in a generation or more to make progress," said Dr. Berwick.

The hearing was led by Chairman Max Baucus (D-Mont.), who scheduled 1 hour for opening statements, testimony, and questioning – an unusually short duration for any congressional committee hearing.

Democratic members of the panel used their allotted 5 minutes of questioning to express enthusiasm for various parts of the ACA and to give Dr. Berwick the opportunity to do the same. Republicans mainly expressed concern that they did not have the ability to properly question Dr. Berwick, given the hearing’s tight timeline.

During his turn to question the CMS administrator, the committee’s ranking minority member, Sen. Chuck Grassley (R-Iowa), wanted to know whether Dr. Berwick supported the conclusions of an April report by Rick Foster, the Medicare Chief Actuary. According to Sen. Grassley, that report said that the reductions envisioned in the ACA would threaten beneficiaries’ access to care.

Dr. Berwick countered that Mr. Foster’s estimates were just that – estimates based on his best judgement.

"Our intention is to increase access to care," he told Sen. Grassley. He added that beneficiaries will "find themselves in better shape after implementation of this act is fully engaged."

Sen. Orrin Hatch (R-Utah) also queried Dr. Berwick about the actuary’s report. But he used most of his time to complain that the CMS Administrator – in charge of a budget that is larger than the Pentagon’s, as he noted – had not been available until that day.

"Obviously, asking us to cover all of our concerns in this hour-long hearing with only 5 minutes...per person, is like asking us to drain the Pacific Ocean with a thimble," Sen. Hatch said.

He said that he hoped that Dr. Berwick would answer any and all questions put to him in writing and that the Administration would allow him to fully answer the queries.

Sen. Hatch and Sen. Grassley and other Republicans asked for additional hearings with Dr. Berwick after the Thanksgiving break, but Chairman Baucus was noncommittal about scheduling such an event.

That prompted a blunt assessment from Sen. Jim Bunning (R-Ky.), who is not returning for the next Congress.

"I can assure you that you will not get special treatment next year," when Republicans hold the majority in the House. "I suspect that you will be spending a lot of time testifying before the House of Representatives, partly because we in the Senate have been shut out," Sen. Bunning said.

WASHINGTON – Dr. Don Berwick, administrator of the Centers for Medicare and Medicaid Services, largely escaped criticism from the Republican senators during his first official appearance on Capitol Hill on Nov. 17, but several senators vowed that they would ensure that he answered all their questions in writing or at another hearing.

Dr. Berwick was appointed by President Obama in July while Congress was in recess. Thus, Dr. Berwick was never subject to confirmation hearings, leaving most Republicans and some Democrats saying that the legislative authority to confirm high-level executive branch appointments had been bypassed.

Speaking before the Finance committee on Nov. 17, Dr. Berwick tried to soothe his potential critics by discussing the potential he sees in addressing the wrongs of the American health care system.

"I feel incredibly lucky to be able to join CMS at a historic time, a time of enormous promise for the future of our nation’s health care," he said. He added that he felt that the federal government "should aim for three goals simultaneously: better care for individuals, better health for the American people, and lower costs through improvement."

The Affordable Care Act (ACA) is "the best opportunity we’ve had in a generation or more to make progress," said Dr. Berwick.

The hearing was led by Chairman Max Baucus (D-Mont.), who scheduled 1 hour for opening statements, testimony, and questioning – an unusually short duration for any congressional committee hearing.

Democratic members of the panel used their allotted 5 minutes of questioning to express enthusiasm for various parts of the ACA and to give Dr. Berwick the opportunity to do the same. Republicans mainly expressed concern that they did not have the ability to properly question Dr. Berwick, given the hearing’s tight timeline.

During his turn to question the CMS administrator, the committee’s ranking minority member, Sen. Chuck Grassley (R-Iowa), wanted to know whether Dr. Berwick supported the conclusions of an April report by Rick Foster, the Medicare Chief Actuary. According to Sen. Grassley, that report said that the reductions envisioned in the ACA would threaten beneficiaries’ access to care.

Dr. Berwick countered that Mr. Foster’s estimates were just that – estimates based on his best judgement.

"Our intention is to increase access to care," he told Sen. Grassley. He added that beneficiaries will "find themselves in better shape after implementation of this act is fully engaged."

Sen. Orrin Hatch (R-Utah) also queried Dr. Berwick about the actuary’s report. But he used most of his time to complain that the CMS Administrator – in charge of a budget that is larger than the Pentagon’s, as he noted – had not been available until that day.

"Obviously, asking us to cover all of our concerns in this hour-long hearing with only 5 minutes...per person, is like asking us to drain the Pacific Ocean with a thimble," Sen. Hatch said.

He said that he hoped that Dr. Berwick would answer any and all questions put to him in writing and that the Administration would allow him to fully answer the queries.

Sen. Hatch and Sen. Grassley and other Republicans asked for additional hearings with Dr. Berwick after the Thanksgiving break, but Chairman Baucus was noncommittal about scheduling such an event.

That prompted a blunt assessment from Sen. Jim Bunning (R-Ky.), who is not returning for the next Congress.

"I can assure you that you will not get special treatment next year," when Republicans hold the majority in the House. "I suspect that you will be spending a lot of time testifying before the House of Representatives, partly because we in the Senate have been shut out," Sen. Bunning said.

WASHINGTON – Dr. Don Berwick, administrator of the Centers for Medicare and Medicaid Services, largely escaped criticism from the Republican senators during his first official appearance on Capitol Hill on Nov. 17, but several senators vowed that they would ensure that he answered all their questions in writing or at another hearing.

Dr. Berwick was appointed by President Obama in July while Congress was in recess. Thus, Dr. Berwick was never subject to confirmation hearings, leaving most Republicans and some Democrats saying that the legislative authority to confirm high-level executive branch appointments had been bypassed.

Speaking before the Finance committee on Nov. 17, Dr. Berwick tried to soothe his potential critics by discussing the potential he sees in addressing the wrongs of the American health care system.

"I feel incredibly lucky to be able to join CMS at a historic time, a time of enormous promise for the future of our nation’s health care," he said. He added that he felt that the federal government "should aim for three goals simultaneously: better care for individuals, better health for the American people, and lower costs through improvement."

The Affordable Care Act (ACA) is "the best opportunity we’ve had in a generation or more to make progress," said Dr. Berwick.

The hearing was led by Chairman Max Baucus (D-Mont.), who scheduled 1 hour for opening statements, testimony, and questioning – an unusually short duration for any congressional committee hearing.

Democratic members of the panel used their allotted 5 minutes of questioning to express enthusiasm for various parts of the ACA and to give Dr. Berwick the opportunity to do the same. Republicans mainly expressed concern that they did not have the ability to properly question Dr. Berwick, given the hearing’s tight timeline.

During his turn to question the CMS administrator, the committee’s ranking minority member, Sen. Chuck Grassley (R-Iowa), wanted to know whether Dr. Berwick supported the conclusions of an April report by Rick Foster, the Medicare Chief Actuary. According to Sen. Grassley, that report said that the reductions envisioned in the ACA would threaten beneficiaries’ access to care.

Dr. Berwick countered that Mr. Foster’s estimates were just that – estimates based on his best judgement.

"Our intention is to increase access to care," he told Sen. Grassley. He added that beneficiaries will "find themselves in better shape after implementation of this act is fully engaged."

Sen. Orrin Hatch (R-Utah) also queried Dr. Berwick about the actuary’s report. But he used most of his time to complain that the CMS Administrator – in charge of a budget that is larger than the Pentagon’s, as he noted – had not been available until that day.

"Obviously, asking us to cover all of our concerns in this hour-long hearing with only 5 minutes...per person, is like asking us to drain the Pacific Ocean with a thimble," Sen. Hatch said.

He said that he hoped that Dr. Berwick would answer any and all questions put to him in writing and that the Administration would allow him to fully answer the queries.

Sen. Hatch and Sen. Grassley and other Republicans asked for additional hearings with Dr. Berwick after the Thanksgiving break, but Chairman Baucus was noncommittal about scheduling such an event.

That prompted a blunt assessment from Sen. Jim Bunning (R-Ky.), who is not returning for the next Congress.

"I can assure you that you will not get special treatment next year," when Republicans hold the majority in the House. "I suspect that you will be spending a lot of time testifying before the House of Representatives, partly because we in the Senate have been shut out," Sen. Bunning said.

WASHINGTON – Dr. Don Berwick, administrator of the Centers for Medicare and Medicaid Services, largely escaped criticism from the Republican senators during his first official appearance on Capitol Hill on Nov. 17, but several senators vowed that they would ensure that he answered all their questions in writing or at another hearing.

Dr. Berwick was appointed by President Obama in July while Congress was in recess. Thus, Dr. Berwick was never subject to confirmation hearings, leaving most Republicans and some Democrats saying that the legislative authority to confirm high-level executive branch appointments had been bypassed.

Speaking before the Finance committee on Nov. 17, Dr. Berwick tried to soothe his potential critics by discussing the potential he sees in addressing the wrongs of the American health care system.

"I feel incredibly lucky to be able to join CMS at a historic time, a time of enormous promise for the future of our nation’s health care," he said. He added that he felt that the federal government "should aim for three goals simultaneously: better care for individuals, better health for the American people, and lower costs through improvement."

The Affordable Care Act (ACA) is "the best opportunity we’ve had in a generation or more to make progress," said Dr. Berwick.

The hearing was led by Chairman Max Baucus (D-Mont.), who scheduled 1 hour for opening statements, testimony, and questioning – an unusually short duration for any congressional committee hearing.

Democratic members of the panel used their allotted 5 minutes of questioning to express enthusiasm for various parts of the ACA and to give Dr. Berwick the opportunity to do the same. Republicans mainly expressed concern that they did not have the ability to properly question Dr. Berwick, given the hearing’s tight timeline.

During his turn to question the CMS administrator, the committee’s ranking minority member, Sen. Chuck Grassley (R-Iowa), wanted to know whether Dr. Berwick supported the conclusions of an April report by Rick Foster, the Medicare Chief Actuary. According to Sen. Grassley, that report said that the reductions envisioned in the ACA would threaten beneficiaries’ access to care.

Dr. Berwick countered that Mr. Foster’s estimates were just that – estimates based on his best judgement.

"Our intention is to increase access to care," he told Sen. Grassley. He added that beneficiaries will "find themselves in better shape after implementation of this act is fully engaged."

Sen. Orrin Hatch (R-Utah) also queried Dr. Berwick about the actuary’s report. But he used most of his time to complain that the CMS Administrator – in charge of a budget that is larger than the Pentagon’s, as he noted – had not been available until that day.

"Obviously, asking us to cover all of our concerns in this hour-long hearing with only 5 minutes...per person, is like asking us to drain the Pacific Ocean with a thimble," Sen. Hatch said.

He said that he hoped that Dr. Berwick would answer any and all questions put to him in writing and that the Administration would allow him to fully answer the queries.

Sen. Hatch and Sen. Grassley and other Republicans asked for additional hearings with Dr. Berwick after the Thanksgiving break, but Chairman Baucus was noncommittal about scheduling such an event.

That prompted a blunt assessment from Sen. Jim Bunning (R-Ky.), who is not returning for the next Congress.

"I can assure you that you will not get special treatment next year," when Republicans hold the majority in the House. "I suspect that you will be spending a lot of time testifying before the House of Representatives, partly because we in the Senate have been shut out," Sen. Bunning said.

The use of comparative effectiveness research would give Medicare a sophisticated tool for making coverage decisions on the basis of quality, but the federal health program's ability to use such data is hamstrung by political interests and the new health reform law, according to two researchers.

“We believe that the time is ripe for Medicare to use comparative effectiveness research to reach a new paradigm of paying equally for services that provide equivalent results,” said Dr. Steven D. Pearson, president of the Institute for Clinical and Economic Review, Boston, and Dr. Peter B. Bach of Memorial Sloan-Kettering Cancer Center, New York (Health Affairs 2010;29:1796-804).

The Obama administration is helping create a larger comparative effectiveness enterprise through some $1.1 billion that was set aside as part of the American Recovery and Reinvestment Act of 2009, and 15 experts are to guide investments and coordinate research through the Federal Coordinating Council for Comparative Effectiveness Research.

However, the council's role is limited. It will not set clinical guidelines, or establish payment rates, or tell Medicare what to cover. The Act further spelled out restrictions on how comparative effectiveness findings could be used by the federal government.

Currently, Medicare covers a drug, device, product, or service if the evidence supports its effectiveness. No comparisons are made to comparable technologies. Payment is set separately, based on arcane formulas that cover cost and maybe a small profit.

Dr. Pearson and Dr. Bach propose that Medicare instead link coverage and payment decisions at the outset. The program could still use the “reasonable and necessary” threshold in deciding when to cover a product or service. But regulators could adopt a three-tiered effectiveness scale that would let them assign differing reimbursement to each level.

For instance, a superior rating would garner the highest payment. Such a product would have the fewest side effects or offer the most effective treatment when compared with similar treatments.

Next down would be the “comparable” product or service. Payment would be slightly less than that for the superior product, as in the difference between what is paid for a brand name and a generic pharmaceutical, for example.

The lowest rating would be “insufficient evidence.” The service would be covered and reimbursed at the conventional cost plus a small profit, but the payment level would be reevaluated every 3 years.

The authors said that a 3-year time frame can act as both a carrot and a stick. Having coverage at current Medicare rates is better than not having coverage, so innovation will not be stifled. But limiting that rate to only 3 years gives manufacturers and clinicians greater incentives to conduct comparative effectiveness studies, they said.

The new payment and coverage scheme might end up restricting access to new services, but the authors said they believe the “trade-off would be justifiable” because the services being reimbursed at the lower rate would have the least amount of evidence supporting their use.

They also said that using comparative effectiveness data, although threatening to manufacturers, might actually end up encouraging the development of superior products and services. “Paying more for better results is the best way to spur the kind of innovation desired most by patients, clinicians, and payers,” they wrote.

The new approach raises conundrums, they noted. It could be difficult to rate a service if effectiveness differed across patient subgroups. And there is the question of whether previously covered services should be grandfathered in. But overall, said Dr. Pearson and Dr. Bach, using comparative effectiveness data to guide payment would benefit both Medicare and physicians, who would no longer have “perverse incentives to invest in and deliver services that add to the cost but not the quality of care.”

Dr. Pearson and Dr. Bach reported no conflicts.

The use of comparative effectiveness research would give Medicare a sophisticated tool for making coverage decisions on the basis of quality, but the federal health program's ability to use such data is hamstrung by political interests and the new health reform law, according to two researchers.

“We believe that the time is ripe for Medicare to use comparative effectiveness research to reach a new paradigm of paying equally for services that provide equivalent results,” said Dr. Steven D. Pearson, president of the Institute for Clinical and Economic Review, Boston, and Dr. Peter B. Bach of Memorial Sloan-Kettering Cancer Center, New York (Health Affairs 2010;29:1796-804).

The Obama administration is helping create a larger comparative effectiveness enterprise through some $1.1 billion that was set aside as part of the American Recovery and Reinvestment Act of 2009, and 15 experts are to guide investments and coordinate research through the Federal Coordinating Council for Comparative Effectiveness Research.

However, the council's role is limited. It will not set clinical guidelines, or establish payment rates, or tell Medicare what to cover. The Act further spelled out restrictions on how comparative effectiveness findings could be used by the federal government.

Currently, Medicare covers a drug, device, product, or service if the evidence supports its effectiveness. No comparisons are made to comparable technologies. Payment is set separately, based on arcane formulas that cover cost and maybe a small profit.

Dr. Pearson and Dr. Bach propose that Medicare instead link coverage and payment decisions at the outset. The program could still use the “reasonable and necessary” threshold in deciding when to cover a product or service. But regulators could adopt a three-tiered effectiveness scale that would let them assign differing reimbursement to each level.

For instance, a superior rating would garner the highest payment. Such a product would have the fewest side effects or offer the most effective treatment when compared with similar treatments.

Next down would be the “comparable” product or service. Payment would be slightly less than that for the superior product, as in the difference between what is paid for a brand name and a generic pharmaceutical, for example.

The lowest rating would be “insufficient evidence.” The service would be covered and reimbursed at the conventional cost plus a small profit, but the payment level would be reevaluated every 3 years.

The authors said that a 3-year time frame can act as both a carrot and a stick. Having coverage at current Medicare rates is better than not having coverage, so innovation will not be stifled. But limiting that rate to only 3 years gives manufacturers and clinicians greater incentives to conduct comparative effectiveness studies, they said.

The new payment and coverage scheme might end up restricting access to new services, but the authors said they believe the “trade-off would be justifiable” because the services being reimbursed at the lower rate would have the least amount of evidence supporting their use.

They also said that using comparative effectiveness data, although threatening to manufacturers, might actually end up encouraging the development of superior products and services. “Paying more for better results is the best way to spur the kind of innovation desired most by patients, clinicians, and payers,” they wrote.

The new approach raises conundrums, they noted. It could be difficult to rate a service if effectiveness differed across patient subgroups. And there is the question of whether previously covered services should be grandfathered in. But overall, said Dr. Pearson and Dr. Bach, using comparative effectiveness data to guide payment would benefit both Medicare and physicians, who would no longer have “perverse incentives to invest in and deliver services that add to the cost but not the quality of care.”

Dr. Pearson and Dr. Bach reported no conflicts.

The use of comparative effectiveness research would give Medicare a sophisticated tool for making coverage decisions on the basis of quality, but the federal health program's ability to use such data is hamstrung by political interests and the new health reform law, according to two researchers.

“We believe that the time is ripe for Medicare to use comparative effectiveness research to reach a new paradigm of paying equally for services that provide equivalent results,” said Dr. Steven D. Pearson, president of the Institute for Clinical and Economic Review, Boston, and Dr. Peter B. Bach of Memorial Sloan-Kettering Cancer Center, New York (Health Affairs 2010;29:1796-804).

The Obama administration is helping create a larger comparative effectiveness enterprise through some $1.1 billion that was set aside as part of the American Recovery and Reinvestment Act of 2009, and 15 experts are to guide investments and coordinate research through the Federal Coordinating Council for Comparative Effectiveness Research.

However, the council's role is limited. It will not set clinical guidelines, or establish payment rates, or tell Medicare what to cover. The Act further spelled out restrictions on how comparative effectiveness findings could be used by the federal government.

Currently, Medicare covers a drug, device, product, or service if the evidence supports its effectiveness. No comparisons are made to comparable technologies. Payment is set separately, based on arcane formulas that cover cost and maybe a small profit.

Dr. Pearson and Dr. Bach propose that Medicare instead link coverage and payment decisions at the outset. The program could still use the “reasonable and necessary” threshold in deciding when to cover a product or service. But regulators could adopt a three-tiered effectiveness scale that would let them assign differing reimbursement to each level.

For instance, a superior rating would garner the highest payment. Such a product would have the fewest side effects or offer the most effective treatment when compared with similar treatments.

Next down would be the “comparable” product or service. Payment would be slightly less than that for the superior product, as in the difference between what is paid for a brand name and a generic pharmaceutical, for example.

The lowest rating would be “insufficient evidence.” The service would be covered and reimbursed at the conventional cost plus a small profit, but the payment level would be reevaluated every 3 years.

The authors said that a 3-year time frame can act as both a carrot and a stick. Having coverage at current Medicare rates is better than not having coverage, so innovation will not be stifled. But limiting that rate to only 3 years gives manufacturers and clinicians greater incentives to conduct comparative effectiveness studies, they said.

The new payment and coverage scheme might end up restricting access to new services, but the authors said they believe the “trade-off would be justifiable” because the services being reimbursed at the lower rate would have the least amount of evidence supporting their use.

They also said that using comparative effectiveness data, although threatening to manufacturers, might actually end up encouraging the development of superior products and services. “Paying more for better results is the best way to spur the kind of innovation desired most by patients, clinicians, and payers,” they wrote.

The new approach raises conundrums, they noted. It could be difficult to rate a service if effectiveness differed across patient subgroups. And there is the question of whether previously covered services should be grandfathered in. But overall, said Dr. Pearson and Dr. Bach, using comparative effectiveness data to guide payment would benefit both Medicare and physicians, who would no longer have “perverse incentives to invest in and deliver services that add to the cost but not the quality of care.”

Dr. Pearson and Dr. Bach reported no conflicts.