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In Stopgap Move, Congress Extends SCHIP Until 2009
After months of debate and two presidential vetoes, Congress has voted to extend the State Children's Health Insurance Program to April 2009.
President Bush signed the legislation on December 29th. The SCHIP extension is included in a bill that also addressed Medicare physician reimbursement, payments for Part B drugs, lab tests used by diabetics, and long-term care hospitals.
Authorization for SCHIP expired Sept. 30. The program continued to operate through two continuing resolutions that kept the entire federal government funded until mid-December while lawmakers and the President wrangled over a 5-year reauthorization.
The showdown ended in late December when the Senate and House both agreed to a stripped-down version of the Democrats' wish list. Congress voted to allocate enough federal funds to keep SCHIP enrollment at 2007 levels—or about 6 million children and adults—through March 31, 2009. Democrats had sought to broaden SCHIP to cover 10 million children.
And the bill provided enough funding to keep programs afloat in a handful of states that were facing budgetary shortfalls.
Democrats and child advocates were relieved that the program was at least extended temporarily, but many expressed concern about SCHIP's future.
“Today we passed a package that puts a band-aid on Medicare and buys just a little more time for families currently relying on SCHIP to keep their children healthy,” Rep. Charles B. Rangel (D-N.Y.) said in a statement. “My concern with this legislation is not what's in it, but what's not in it.”
House Speaker Nancy Pelosi issued a statement noting that the bill “does not make headway in reducing the number of uninsured.”
Some Republicans weren't happy, either. Sen. Charles Grassley (R-Iowa) said that although the original bill was passed unanimously in the Senate, he knew that the bill fell short of what many in Congress were hoping for. “I do hope we can do more when we come back next year,” he said in a statement.
The SCHIP package that was passed did not—as Democrats had preferred—reverse a directive issued by the Centers for Medicare and Medicaid Services last August. States were notified that if they were raising eligibility for children whose family incomes were equal to or above 250% of the federal poverty level, they would have to meet stringent new requirements. Primarily, states would have to prove that 95% of eligible children—those at 250% of poverty—were enrolled. The goal: to ensure that these families are not opting for SCHIP instead of private insurance.
States must meet that target by August 2008. In a briefing with reporters, Acting CMS Administrator Kerry Weems said that at least two states, Vermont and Massachusetts, will soon meet the goal. Currently, there is no set enforcement plan, he said. The CMS would likely look at each state individually to determine whether it was meeting the directive, Mr. Weems said.
In a conference call with reporters, Robert Greenstein, executive director of the Center on Budget and Policy Priorities, a Washington think tank, said the directive could have a huge impact on enrollment. Fourteen states cover children above 250% of poverty, and 10 more had plans to expand eligibility above that level. Thus, the SCHIP bill “was not a maintenance of the current situation but backwards progress,” he said.
After months of debate and two presidential vetoes, Congress has voted to extend the State Children's Health Insurance Program to April 2009.
President Bush signed the legislation on December 29th. The SCHIP extension is included in a bill that also addressed Medicare physician reimbursement, payments for Part B drugs, lab tests used by diabetics, and long-term care hospitals.
Authorization for SCHIP expired Sept. 30. The program continued to operate through two continuing resolutions that kept the entire federal government funded until mid-December while lawmakers and the President wrangled over a 5-year reauthorization.
The showdown ended in late December when the Senate and House both agreed to a stripped-down version of the Democrats' wish list. Congress voted to allocate enough federal funds to keep SCHIP enrollment at 2007 levels—or about 6 million children and adults—through March 31, 2009. Democrats had sought to broaden SCHIP to cover 10 million children.
And the bill provided enough funding to keep programs afloat in a handful of states that were facing budgetary shortfalls.
Democrats and child advocates were relieved that the program was at least extended temporarily, but many expressed concern about SCHIP's future.
“Today we passed a package that puts a band-aid on Medicare and buys just a little more time for families currently relying on SCHIP to keep their children healthy,” Rep. Charles B. Rangel (D-N.Y.) said in a statement. “My concern with this legislation is not what's in it, but what's not in it.”
House Speaker Nancy Pelosi issued a statement noting that the bill “does not make headway in reducing the number of uninsured.”
Some Republicans weren't happy, either. Sen. Charles Grassley (R-Iowa) said that although the original bill was passed unanimously in the Senate, he knew that the bill fell short of what many in Congress were hoping for. “I do hope we can do more when we come back next year,” he said in a statement.
The SCHIP package that was passed did not—as Democrats had preferred—reverse a directive issued by the Centers for Medicare and Medicaid Services last August. States were notified that if they were raising eligibility for children whose family incomes were equal to or above 250% of the federal poverty level, they would have to meet stringent new requirements. Primarily, states would have to prove that 95% of eligible children—those at 250% of poverty—were enrolled. The goal: to ensure that these families are not opting for SCHIP instead of private insurance.
States must meet that target by August 2008. In a briefing with reporters, Acting CMS Administrator Kerry Weems said that at least two states, Vermont and Massachusetts, will soon meet the goal. Currently, there is no set enforcement plan, he said. The CMS would likely look at each state individually to determine whether it was meeting the directive, Mr. Weems said.
In a conference call with reporters, Robert Greenstein, executive director of the Center on Budget and Policy Priorities, a Washington think tank, said the directive could have a huge impact on enrollment. Fourteen states cover children above 250% of poverty, and 10 more had plans to expand eligibility above that level. Thus, the SCHIP bill “was not a maintenance of the current situation but backwards progress,” he said.
After months of debate and two presidential vetoes, Congress has voted to extend the State Children's Health Insurance Program to April 2009.
President Bush signed the legislation on December 29th. The SCHIP extension is included in a bill that also addressed Medicare physician reimbursement, payments for Part B drugs, lab tests used by diabetics, and long-term care hospitals.
Authorization for SCHIP expired Sept. 30. The program continued to operate through two continuing resolutions that kept the entire federal government funded until mid-December while lawmakers and the President wrangled over a 5-year reauthorization.
The showdown ended in late December when the Senate and House both agreed to a stripped-down version of the Democrats' wish list. Congress voted to allocate enough federal funds to keep SCHIP enrollment at 2007 levels—or about 6 million children and adults—through March 31, 2009. Democrats had sought to broaden SCHIP to cover 10 million children.
And the bill provided enough funding to keep programs afloat in a handful of states that were facing budgetary shortfalls.
Democrats and child advocates were relieved that the program was at least extended temporarily, but many expressed concern about SCHIP's future.
“Today we passed a package that puts a band-aid on Medicare and buys just a little more time for families currently relying on SCHIP to keep their children healthy,” Rep. Charles B. Rangel (D-N.Y.) said in a statement. “My concern with this legislation is not what's in it, but what's not in it.”
House Speaker Nancy Pelosi issued a statement noting that the bill “does not make headway in reducing the number of uninsured.”
Some Republicans weren't happy, either. Sen. Charles Grassley (R-Iowa) said that although the original bill was passed unanimously in the Senate, he knew that the bill fell short of what many in Congress were hoping for. “I do hope we can do more when we come back next year,” he said in a statement.
The SCHIP package that was passed did not—as Democrats had preferred—reverse a directive issued by the Centers for Medicare and Medicaid Services last August. States were notified that if they were raising eligibility for children whose family incomes were equal to or above 250% of the federal poverty level, they would have to meet stringent new requirements. Primarily, states would have to prove that 95% of eligible children—those at 250% of poverty—were enrolled. The goal: to ensure that these families are not opting for SCHIP instead of private insurance.
States must meet that target by August 2008. In a briefing with reporters, Acting CMS Administrator Kerry Weems said that at least two states, Vermont and Massachusetts, will soon meet the goal. Currently, there is no set enforcement plan, he said. The CMS would likely look at each state individually to determine whether it was meeting the directive, Mr. Weems said.
In a conference call with reporters, Robert Greenstein, executive director of the Center on Budget and Policy Priorities, a Washington think tank, said the directive could have a huge impact on enrollment. Fourteen states cover children above 250% of poverty, and 10 more had plans to expand eligibility above that level. Thus, the SCHIP bill “was not a maintenance of the current situation but backwards progress,” he said.
SCHIP Gets Extension to April 2009
After months of debate and two presidential vetoes, Congress voted to extend the State Children's Health Insurance Program to April 2009. President Bush signed the legislation on Dec. 29.
The SCHIP extension is included in a bill that also addressed Medicare physician reimbursement, payments for Part B drugs, lab tests used by diabetics, and long-term care hospitals.
Authorization for SCHIP expired Sept. 30. The program continued to operate through two continuing resolutions that kept the entire federal government funded until mid-December while lawmakers and the President wrangled over a 5-year reauthorization.
The showdown ended in late December when the Senate and House both agreed to a stripped-down version of the Democrats' wish list. Congress voted to allocate enough federal funds to keep SCHIP enrollment at 2007 levels—or about 6 million children and adults—through March 31, 2009. Democrats have sought to broaden SCHIP to cover 10 million children.
And the bill provided enough funding to keep programs afloat in a handful of states that were facing budgetary shortfalls.
Democrats and child advocates were relieved that the program was at least extended temporarily, but many expressed concern about SCHIP's future. House Speaker Nancy Pelosi issued a statement noting that the bill “does not make headway in reducing the number of uninsured.”
Sen. Charles Grassley (R-Iowa) said that although the original bill was passed unanimously in the Senate, he knew that the bill fell short of what many in Congress were hoping for.
The SCHIP package did not—as Democrats wanted—reverse a directive issued by the Centers for Medicare and Medicaid Services last August. States were notified that if they were raising eligibility for children whose family incomes were equal to or above 250% of the federal poverty level, they would have to meet stringent new requirements. Primarily, states would have to prove that 95% of eligible children—those at 250% of poverty—were enrolled. The goal: to ensure that these families are not opting for SCHIP instead of private insurance.
States must meet that target by August 2008. Fourteen states already cover children above 250% of poverty, and 10 more had plans to expand eligibility above that level.
After months of debate and two presidential vetoes, Congress voted to extend the State Children's Health Insurance Program to April 2009. President Bush signed the legislation on Dec. 29.
The SCHIP extension is included in a bill that also addressed Medicare physician reimbursement, payments for Part B drugs, lab tests used by diabetics, and long-term care hospitals.
Authorization for SCHIP expired Sept. 30. The program continued to operate through two continuing resolutions that kept the entire federal government funded until mid-December while lawmakers and the President wrangled over a 5-year reauthorization.
The showdown ended in late December when the Senate and House both agreed to a stripped-down version of the Democrats' wish list. Congress voted to allocate enough federal funds to keep SCHIP enrollment at 2007 levels—or about 6 million children and adults—through March 31, 2009. Democrats have sought to broaden SCHIP to cover 10 million children.
And the bill provided enough funding to keep programs afloat in a handful of states that were facing budgetary shortfalls.
Democrats and child advocates were relieved that the program was at least extended temporarily, but many expressed concern about SCHIP's future. House Speaker Nancy Pelosi issued a statement noting that the bill “does not make headway in reducing the number of uninsured.”
Sen. Charles Grassley (R-Iowa) said that although the original bill was passed unanimously in the Senate, he knew that the bill fell short of what many in Congress were hoping for.
The SCHIP package did not—as Democrats wanted—reverse a directive issued by the Centers for Medicare and Medicaid Services last August. States were notified that if they were raising eligibility for children whose family incomes were equal to or above 250% of the federal poverty level, they would have to meet stringent new requirements. Primarily, states would have to prove that 95% of eligible children—those at 250% of poverty—were enrolled. The goal: to ensure that these families are not opting for SCHIP instead of private insurance.
States must meet that target by August 2008. Fourteen states already cover children above 250% of poverty, and 10 more had plans to expand eligibility above that level.
After months of debate and two presidential vetoes, Congress voted to extend the State Children's Health Insurance Program to April 2009. President Bush signed the legislation on Dec. 29.
The SCHIP extension is included in a bill that also addressed Medicare physician reimbursement, payments for Part B drugs, lab tests used by diabetics, and long-term care hospitals.
Authorization for SCHIP expired Sept. 30. The program continued to operate through two continuing resolutions that kept the entire federal government funded until mid-December while lawmakers and the President wrangled over a 5-year reauthorization.
The showdown ended in late December when the Senate and House both agreed to a stripped-down version of the Democrats' wish list. Congress voted to allocate enough federal funds to keep SCHIP enrollment at 2007 levels—or about 6 million children and adults—through March 31, 2009. Democrats have sought to broaden SCHIP to cover 10 million children.
And the bill provided enough funding to keep programs afloat in a handful of states that were facing budgetary shortfalls.
Democrats and child advocates were relieved that the program was at least extended temporarily, but many expressed concern about SCHIP's future. House Speaker Nancy Pelosi issued a statement noting that the bill “does not make headway in reducing the number of uninsured.”
Sen. Charles Grassley (R-Iowa) said that although the original bill was passed unanimously in the Senate, he knew that the bill fell short of what many in Congress were hoping for.
The SCHIP package did not—as Democrats wanted—reverse a directive issued by the Centers for Medicare and Medicaid Services last August. States were notified that if they were raising eligibility for children whose family incomes were equal to or above 250% of the federal poverty level, they would have to meet stringent new requirements. Primarily, states would have to prove that 95% of eligible children—those at 250% of poverty—were enrolled. The goal: to ensure that these families are not opting for SCHIP instead of private insurance.
States must meet that target by August 2008. Fourteen states already cover children above 250% of poverty, and 10 more had plans to expand eligibility above that level.
FDA Sets New Conflict-of-Interest Rules for Advisory Panels
The Food and Drug Administration said it wants to require more public disclosure of advisory committee members' conflicts of interest and the information will be available on a new and improved Web site.
The agency also said it will also post more data in advance of upcoming meetings.
The changes were announced in November in a draft guidance, which does not carry the weight of a rule, but is generally followed by most companies that have products regulated by the FDA. A draft guidance represents the agency's “current thinking on the topic.”
According to the FDA, the new emphasis on disclosure is a response to recommendations made by the Institute of Medicine in its 2006 report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public.”
The draft guidance will apply to all members of the 31 current advisory panels. Committee members are either government employees or outsiders who are designated as special government employees. The FDA will ask panelists to state publicly the type, nature, and magnitude of any “disqualifying financial interests.”
Panel members will be required to complete a waiver request when they have a financial conflict. As part of that document, they'll list the nature of the interest (for instance, whether it's a stock holding, or if they've been a paid consultant or an expert witness); whether the conflicting relationship is with the sponsor or a competitor; and the value of the remuneration, up to $50,000. At least 15 days before an advisory committee meeting, any disclosures from panelists will be posted on the Web site, along with the agency's waiver decision. Currently, waivers may or may not be posted a few days in advance of a committee meeting, and are read aloud at the start of the proceedings.
Critics have charged that panel reviews of products have become less rigorous because so many committee members have conflicts of interest. Essentially, the panels are biased in favor of approval, critics contend.
The National Research Center for Women and Families, a consumer advocacy group, issued a report in 2006 showing that advisory panels backed approval for 76% of new drugs and 82% of new medical devices, and that 96% of those products were later approved by the FDA.
The new guidance “focuses on disclosure, not on change,” Diana Zuckerman, Ph.D., president of the National Research Center, said in an interview. “Although disclosure is nice, it doesn't solve the problems.”
A recent report that was commissioned by the FDA concluded that creating conflict-free panels would require higher recruiting and screening costs, and would take much more time than the current process, potentially delaying important decisions.
Eastern Research Group, a consulting firm in Lexington, Mass., studied 16 advisory committee meetings that involved 124 panel members. Of the 124, 32 (26%) required waivers for at least one meeting. Almost the same number required waivers for multiple meetings. An equal number of standing members and consumer representatives required waivers (29%). More than half of patient representatives required waivers.
Dr. Zuckerman questioned the study's validity, noting that the consulting company used literature searches to form the basis of its conclusions on panelists' conflicts. The FDA would be more proactive in searching for conflict-free advisers, she said.
She was in favor of the FDA's proposed new voting procedures. The agency said that it wanted to have simultaneous votes. Currently, committees often have panelists vote individually, one by one. That can influence the votes of successive voting members.
Even with this reform, Dr. Zuckerman said she was not satisfied. “I do actually think it's mostly a sham process,” she said. “I don't believe that these are independent scientific advisory committees.”
The Food and Drug Administration said it wants to require more public disclosure of advisory committee members' conflicts of interest and the information will be available on a new and improved Web site.
The agency also said it will also post more data in advance of upcoming meetings.
The changes were announced in November in a draft guidance, which does not carry the weight of a rule, but is generally followed by most companies that have products regulated by the FDA. A draft guidance represents the agency's “current thinking on the topic.”
According to the FDA, the new emphasis on disclosure is a response to recommendations made by the Institute of Medicine in its 2006 report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public.”
The draft guidance will apply to all members of the 31 current advisory panels. Committee members are either government employees or outsiders who are designated as special government employees. The FDA will ask panelists to state publicly the type, nature, and magnitude of any “disqualifying financial interests.”
Panel members will be required to complete a waiver request when they have a financial conflict. As part of that document, they'll list the nature of the interest (for instance, whether it's a stock holding, or if they've been a paid consultant or an expert witness); whether the conflicting relationship is with the sponsor or a competitor; and the value of the remuneration, up to $50,000. At least 15 days before an advisory committee meeting, any disclosures from panelists will be posted on the Web site, along with the agency's waiver decision. Currently, waivers may or may not be posted a few days in advance of a committee meeting, and are read aloud at the start of the proceedings.
Critics have charged that panel reviews of products have become less rigorous because so many committee members have conflicts of interest. Essentially, the panels are biased in favor of approval, critics contend.
The National Research Center for Women and Families, a consumer advocacy group, issued a report in 2006 showing that advisory panels backed approval for 76% of new drugs and 82% of new medical devices, and that 96% of those products were later approved by the FDA.
The new guidance “focuses on disclosure, not on change,” Diana Zuckerman, Ph.D., president of the National Research Center, said in an interview. “Although disclosure is nice, it doesn't solve the problems.”
A recent report that was commissioned by the FDA concluded that creating conflict-free panels would require higher recruiting and screening costs, and would take much more time than the current process, potentially delaying important decisions.
Eastern Research Group, a consulting firm in Lexington, Mass., studied 16 advisory committee meetings that involved 124 panel members. Of the 124, 32 (26%) required waivers for at least one meeting. Almost the same number required waivers for multiple meetings. An equal number of standing members and consumer representatives required waivers (29%). More than half of patient representatives required waivers.
Dr. Zuckerman questioned the study's validity, noting that the consulting company used literature searches to form the basis of its conclusions on panelists' conflicts. The FDA would be more proactive in searching for conflict-free advisers, she said.
She was in favor of the FDA's proposed new voting procedures. The agency said that it wanted to have simultaneous votes. Currently, committees often have panelists vote individually, one by one. That can influence the votes of successive voting members.
Even with this reform, Dr. Zuckerman said she was not satisfied. “I do actually think it's mostly a sham process,” she said. “I don't believe that these are independent scientific advisory committees.”
The Food and Drug Administration said it wants to require more public disclosure of advisory committee members' conflicts of interest and the information will be available on a new and improved Web site.
The agency also said it will also post more data in advance of upcoming meetings.
The changes were announced in November in a draft guidance, which does not carry the weight of a rule, but is generally followed by most companies that have products regulated by the FDA. A draft guidance represents the agency's “current thinking on the topic.”
According to the FDA, the new emphasis on disclosure is a response to recommendations made by the Institute of Medicine in its 2006 report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public.”
The draft guidance will apply to all members of the 31 current advisory panels. Committee members are either government employees or outsiders who are designated as special government employees. The FDA will ask panelists to state publicly the type, nature, and magnitude of any “disqualifying financial interests.”
Panel members will be required to complete a waiver request when they have a financial conflict. As part of that document, they'll list the nature of the interest (for instance, whether it's a stock holding, or if they've been a paid consultant or an expert witness); whether the conflicting relationship is with the sponsor or a competitor; and the value of the remuneration, up to $50,000. At least 15 days before an advisory committee meeting, any disclosures from panelists will be posted on the Web site, along with the agency's waiver decision. Currently, waivers may or may not be posted a few days in advance of a committee meeting, and are read aloud at the start of the proceedings.
Critics have charged that panel reviews of products have become less rigorous because so many committee members have conflicts of interest. Essentially, the panels are biased in favor of approval, critics contend.
The National Research Center for Women and Families, a consumer advocacy group, issued a report in 2006 showing that advisory panels backed approval for 76% of new drugs and 82% of new medical devices, and that 96% of those products were later approved by the FDA.
The new guidance “focuses on disclosure, not on change,” Diana Zuckerman, Ph.D., president of the National Research Center, said in an interview. “Although disclosure is nice, it doesn't solve the problems.”
A recent report that was commissioned by the FDA concluded that creating conflict-free panels would require higher recruiting and screening costs, and would take much more time than the current process, potentially delaying important decisions.
Eastern Research Group, a consulting firm in Lexington, Mass., studied 16 advisory committee meetings that involved 124 panel members. Of the 124, 32 (26%) required waivers for at least one meeting. Almost the same number required waivers for multiple meetings. An equal number of standing members and consumer representatives required waivers (29%). More than half of patient representatives required waivers.
Dr. Zuckerman questioned the study's validity, noting that the consulting company used literature searches to form the basis of its conclusions on panelists' conflicts. The FDA would be more proactive in searching for conflict-free advisers, she said.
She was in favor of the FDA's proposed new voting procedures. The agency said that it wanted to have simultaneous votes. Currently, committees often have panelists vote individually, one by one. That can influence the votes of successive voting members.
Even with this reform, Dr. Zuckerman said she was not satisfied. “I do actually think it's mostly a sham process,” she said. “I don't believe that these are independent scientific advisory committees.”
E-Prescribing Standards Are Proposed for Medicare Use
The U.S. Health and Human Services Department has proposed federal e-prescribing standards to be used for Medicare participating physicians, pharmacists, and software vendors.
The proposal was issued last month; comments are being accepted through mid-January.
E-prescribing is not required for participation in the Medicare Part D drug benefit.
But under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003—the law that established the benefit—drug plans, physicians, and pharmacists who use electronic prescribing are required to meet the HHS standards.
Some organizations have pushed for required e-prescribing for Medicare participation.
The Pharmaceutical Care Management Association (PCMA), which represents pharmacy benefit managers, is spearheading the effort. The organization launched a print and broadcast ad campaign in November that called for adoption of e-prescribing by 2010—the same deadline set by the Institute of Medicine in a report on reducing adverse drug reactions that was issued in July 2006.
The American Health Information Community has also urged the HHS to require e-prescribing for Medicare.
The American Medical Association and other groups oppose a mandate.
“From a practical side, a mandate would be premature,” Stacey Swartz, Pharm.D., senior director of pharmacy affairs at the National Community Pharmacists Association, said in an interview.
“We can see the benefits of it, but we can't ignore that there are costs involved,” she added.
The final e-prescribing standards are expected to be issued by April 1, 2008.
The U.S. Health and Human Services Department has proposed federal e-prescribing standards to be used for Medicare participating physicians, pharmacists, and software vendors.
The proposal was issued last month; comments are being accepted through mid-January.
E-prescribing is not required for participation in the Medicare Part D drug benefit.
But under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003—the law that established the benefit—drug plans, physicians, and pharmacists who use electronic prescribing are required to meet the HHS standards.
Some organizations have pushed for required e-prescribing for Medicare participation.
The Pharmaceutical Care Management Association (PCMA), which represents pharmacy benefit managers, is spearheading the effort. The organization launched a print and broadcast ad campaign in November that called for adoption of e-prescribing by 2010—the same deadline set by the Institute of Medicine in a report on reducing adverse drug reactions that was issued in July 2006.
The American Health Information Community has also urged the HHS to require e-prescribing for Medicare.
The American Medical Association and other groups oppose a mandate.
“From a practical side, a mandate would be premature,” Stacey Swartz, Pharm.D., senior director of pharmacy affairs at the National Community Pharmacists Association, said in an interview.
“We can see the benefits of it, but we can't ignore that there are costs involved,” she added.
The final e-prescribing standards are expected to be issued by April 1, 2008.
The U.S. Health and Human Services Department has proposed federal e-prescribing standards to be used for Medicare participating physicians, pharmacists, and software vendors.
The proposal was issued last month; comments are being accepted through mid-January.
E-prescribing is not required for participation in the Medicare Part D drug benefit.
But under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003—the law that established the benefit—drug plans, physicians, and pharmacists who use electronic prescribing are required to meet the HHS standards.
Some organizations have pushed for required e-prescribing for Medicare participation.
The Pharmaceutical Care Management Association (PCMA), which represents pharmacy benefit managers, is spearheading the effort. The organization launched a print and broadcast ad campaign in November that called for adoption of e-prescribing by 2010—the same deadline set by the Institute of Medicine in a report on reducing adverse drug reactions that was issued in July 2006.
The American Health Information Community has also urged the HHS to require e-prescribing for Medicare.
The American Medical Association and other groups oppose a mandate.
“From a practical side, a mandate would be premature,” Stacey Swartz, Pharm.D., senior director of pharmacy affairs at the National Community Pharmacists Association, said in an interview.
“We can see the benefits of it, but we can't ignore that there are costs involved,” she added.
The final e-prescribing standards are expected to be issued by April 1, 2008.
Care Quality Rises, Driven by Public Reporting
WASHINGTON — Thousands of lives are being saved each year as health plans and physicians more closely follow quality measures such as giving β-blockers after a heart attack, managing hypertension and hypercholesterolemia, and controlling hemoglobin A1c levels, according to the latest report card from the National Committee for Quality Assurance.
And, plans that report publicly on these measures deliver higher quality care, said NCQA president Margaret O'Kane in a briefing.
The NCQA's recently released report card shows that commercial and Medicaid plans that publicly disclose NCQA-tracked quality measures perform anywhere from half a percent to 16% better than plans that do not disclose their data.
However, even with some notable successes, some of the gains—such as in controlling blood sugar—are starting to plateau, said Ms. O'Kane. And, there are still gaps in quality between top-performing and average health plans. Thousands more lives could be saved if the laggards did as well as the top performers in the NCQA database, she said.
The report is based on data that are voluntarily submitted to the NCQA, which also accredits health plans. In 2006, 767 organizations—626 managed care plans covering private patients and Medicare and Medicaid enrollees, and 83 commercial and 58 Medicare PPO plans—submitted data using the NCQA's Healthcare Effectiveness Data and Information Set (HEDIS) .
Much of the data come from claims, but some also come from chart reviews. None of them are adjusted for severity-of-illness, socioeconomic, or other factors.
Approximately 84 million Americans were enrolled in plans that used HEDIS measures to report to the NCQA in 2006. Although that is a big number, at least 100 million Americans are in health plans that do not report quality data, and some 47 million have no insurance, said Ms. O'Kane. The quality picture is completely dark for the uninsured, she said.
But for those plans that did report, the news was good. Overall, commercial plans improved performance in 30 of 44 HEDIS measures where a trend could be discerned, Medicaid plans notched increases in 34 of 43 “trendable” measures, and Medicare plans achieved increase only on 7 of 21 trendable measures.
Among the biggest successes was that 98% of commercial plans, 94% of Medicare, and 88% of Medicaid plans reported prescribing a β-blocker upon discharge after acute myocardial infarction. Over the last 6 years, β-blocker treatment has saved an estimated 4,400–5,600 lives, said Ms. O'Kane.
Given the high prescribing rates, the NCQA will no longer track this measure. Instead, the organization will collect data on how many patients still receive β-blockers 6 months after discharge—currently, only about 74% in commercial plans and 70% for Medicare and Medicaid.
Childhood immunization rates are also at all-time highs, at about 80% for commercial plans and 73% for Medicaid plans for the recommended series of vaccinations.
There has been “stalling” in some of the older HEDIS measures, however, said Ms. O'Kane. Baseline screening for HbA1c has plateaued at 88% in commercial plans and is down slightly for Medicare and Medicaid, at 87% and 78%, respectively.
Cholesterol screening and control of total cholesterol is also trending flat or down. The NCQA has no explanation for the leveling off, said Ms. O'Kane.
Adherence to mental health measures—which are already abysmally low—has also been flat for almost a decade. For instance, only 20% of commercial, 21% of Medicaid, and 11% of Medicare plans are meeting the benchmark of treating newly diagnosed depression patients with an antidepressant and following up with at least three visits within the 12-week acute treatment phase. These rates have stayed virtually the same since 1998.
Similarly, patients who have been hospitalized for a mental illness are not getting quality care, said Ms. O'Kane. Only 57% of patients in commercial plans, 37% of those in a Medicare plan, and 39% of those in a Medicaid plan had a follow-up within a week of hospitalization. Rates improved somewhat a month out, to 75%, 55%, and 58%. Studies have shown that follow-up care decreases the risk of repeat hospitalizations and improves adherence, according to the NCQA.
The low follow-up rates are “a national disgrace,” said Ms. O'Kane, adding that for anyone to be “out 30 days with no one checking on you is unacceptable.”
Several new HEDIS measures are in place for 2007, including tracking of potentially harmful drug-disease interactions in the elderly.
And, for the first time, health plans are being asked to report on their use of resources in treating various conditions. In 2007, they were diabetes, asthma, and low back pain. In 2008, chronic obstructive pulmonary disease, hypertension, and cardiovascular disease have been added. These conditions account for 60% of health care spending, said Ms. O'Kane.
The data will be used to determine the variations in resource use among health plans.
Coupled with the HEDIS quality measures, the NCQA will eventually be able to rate which plans give the best quality care for the least amount of money, said Ms. O'Kane.
WASHINGTON — Thousands of lives are being saved each year as health plans and physicians more closely follow quality measures such as giving β-blockers after a heart attack, managing hypertension and hypercholesterolemia, and controlling hemoglobin A1c levels, according to the latest report card from the National Committee for Quality Assurance.
And, plans that report publicly on these measures deliver higher quality care, said NCQA president Margaret O'Kane in a briefing.
The NCQA's recently released report card shows that commercial and Medicaid plans that publicly disclose NCQA-tracked quality measures perform anywhere from half a percent to 16% better than plans that do not disclose their data.
However, even with some notable successes, some of the gains—such as in controlling blood sugar—are starting to plateau, said Ms. O'Kane. And, there are still gaps in quality between top-performing and average health plans. Thousands more lives could be saved if the laggards did as well as the top performers in the NCQA database, she said.
The report is based on data that are voluntarily submitted to the NCQA, which also accredits health plans. In 2006, 767 organizations—626 managed care plans covering private patients and Medicare and Medicaid enrollees, and 83 commercial and 58 Medicare PPO plans—submitted data using the NCQA's Healthcare Effectiveness Data and Information Set (HEDIS) .
Much of the data come from claims, but some also come from chart reviews. None of them are adjusted for severity-of-illness, socioeconomic, or other factors.
Approximately 84 million Americans were enrolled in plans that used HEDIS measures to report to the NCQA in 2006. Although that is a big number, at least 100 million Americans are in health plans that do not report quality data, and some 47 million have no insurance, said Ms. O'Kane. The quality picture is completely dark for the uninsured, she said.
But for those plans that did report, the news was good. Overall, commercial plans improved performance in 30 of 44 HEDIS measures where a trend could be discerned, Medicaid plans notched increases in 34 of 43 “trendable” measures, and Medicare plans achieved increase only on 7 of 21 trendable measures.
Among the biggest successes was that 98% of commercial plans, 94% of Medicare, and 88% of Medicaid plans reported prescribing a β-blocker upon discharge after acute myocardial infarction. Over the last 6 years, β-blocker treatment has saved an estimated 4,400–5,600 lives, said Ms. O'Kane.
Given the high prescribing rates, the NCQA will no longer track this measure. Instead, the organization will collect data on how many patients still receive β-blockers 6 months after discharge—currently, only about 74% in commercial plans and 70% for Medicare and Medicaid.
Childhood immunization rates are also at all-time highs, at about 80% for commercial plans and 73% for Medicaid plans for the recommended series of vaccinations.
There has been “stalling” in some of the older HEDIS measures, however, said Ms. O'Kane. Baseline screening for HbA1c has plateaued at 88% in commercial plans and is down slightly for Medicare and Medicaid, at 87% and 78%, respectively.
Cholesterol screening and control of total cholesterol is also trending flat or down. The NCQA has no explanation for the leveling off, said Ms. O'Kane.
Adherence to mental health measures—which are already abysmally low—has also been flat for almost a decade. For instance, only 20% of commercial, 21% of Medicaid, and 11% of Medicare plans are meeting the benchmark of treating newly diagnosed depression patients with an antidepressant and following up with at least three visits within the 12-week acute treatment phase. These rates have stayed virtually the same since 1998.
Similarly, patients who have been hospitalized for a mental illness are not getting quality care, said Ms. O'Kane. Only 57% of patients in commercial plans, 37% of those in a Medicare plan, and 39% of those in a Medicaid plan had a follow-up within a week of hospitalization. Rates improved somewhat a month out, to 75%, 55%, and 58%. Studies have shown that follow-up care decreases the risk of repeat hospitalizations and improves adherence, according to the NCQA.
The low follow-up rates are “a national disgrace,” said Ms. O'Kane, adding that for anyone to be “out 30 days with no one checking on you is unacceptable.”
Several new HEDIS measures are in place for 2007, including tracking of potentially harmful drug-disease interactions in the elderly.
And, for the first time, health plans are being asked to report on their use of resources in treating various conditions. In 2007, they were diabetes, asthma, and low back pain. In 2008, chronic obstructive pulmonary disease, hypertension, and cardiovascular disease have been added. These conditions account for 60% of health care spending, said Ms. O'Kane.
The data will be used to determine the variations in resource use among health plans.
Coupled with the HEDIS quality measures, the NCQA will eventually be able to rate which plans give the best quality care for the least amount of money, said Ms. O'Kane.
WASHINGTON — Thousands of lives are being saved each year as health plans and physicians more closely follow quality measures such as giving β-blockers after a heart attack, managing hypertension and hypercholesterolemia, and controlling hemoglobin A1c levels, according to the latest report card from the National Committee for Quality Assurance.
And, plans that report publicly on these measures deliver higher quality care, said NCQA president Margaret O'Kane in a briefing.
The NCQA's recently released report card shows that commercial and Medicaid plans that publicly disclose NCQA-tracked quality measures perform anywhere from half a percent to 16% better than plans that do not disclose their data.
However, even with some notable successes, some of the gains—such as in controlling blood sugar—are starting to plateau, said Ms. O'Kane. And, there are still gaps in quality between top-performing and average health plans. Thousands more lives could be saved if the laggards did as well as the top performers in the NCQA database, she said.
The report is based on data that are voluntarily submitted to the NCQA, which also accredits health plans. In 2006, 767 organizations—626 managed care plans covering private patients and Medicare and Medicaid enrollees, and 83 commercial and 58 Medicare PPO plans—submitted data using the NCQA's Healthcare Effectiveness Data and Information Set (HEDIS) .
Much of the data come from claims, but some also come from chart reviews. None of them are adjusted for severity-of-illness, socioeconomic, or other factors.
Approximately 84 million Americans were enrolled in plans that used HEDIS measures to report to the NCQA in 2006. Although that is a big number, at least 100 million Americans are in health plans that do not report quality data, and some 47 million have no insurance, said Ms. O'Kane. The quality picture is completely dark for the uninsured, she said.
But for those plans that did report, the news was good. Overall, commercial plans improved performance in 30 of 44 HEDIS measures where a trend could be discerned, Medicaid plans notched increases in 34 of 43 “trendable” measures, and Medicare plans achieved increase only on 7 of 21 trendable measures.
Among the biggest successes was that 98% of commercial plans, 94% of Medicare, and 88% of Medicaid plans reported prescribing a β-blocker upon discharge after acute myocardial infarction. Over the last 6 years, β-blocker treatment has saved an estimated 4,400–5,600 lives, said Ms. O'Kane.
Given the high prescribing rates, the NCQA will no longer track this measure. Instead, the organization will collect data on how many patients still receive β-blockers 6 months after discharge—currently, only about 74% in commercial plans and 70% for Medicare and Medicaid.
Childhood immunization rates are also at all-time highs, at about 80% for commercial plans and 73% for Medicaid plans for the recommended series of vaccinations.
There has been “stalling” in some of the older HEDIS measures, however, said Ms. O'Kane. Baseline screening for HbA1c has plateaued at 88% in commercial plans and is down slightly for Medicare and Medicaid, at 87% and 78%, respectively.
Cholesterol screening and control of total cholesterol is also trending flat or down. The NCQA has no explanation for the leveling off, said Ms. O'Kane.
Adherence to mental health measures—which are already abysmally low—has also been flat for almost a decade. For instance, only 20% of commercial, 21% of Medicaid, and 11% of Medicare plans are meeting the benchmark of treating newly diagnosed depression patients with an antidepressant and following up with at least three visits within the 12-week acute treatment phase. These rates have stayed virtually the same since 1998.
Similarly, patients who have been hospitalized for a mental illness are not getting quality care, said Ms. O'Kane. Only 57% of patients in commercial plans, 37% of those in a Medicare plan, and 39% of those in a Medicaid plan had a follow-up within a week of hospitalization. Rates improved somewhat a month out, to 75%, 55%, and 58%. Studies have shown that follow-up care decreases the risk of repeat hospitalizations and improves adherence, according to the NCQA.
The low follow-up rates are “a national disgrace,” said Ms. O'Kane, adding that for anyone to be “out 30 days with no one checking on you is unacceptable.”
Several new HEDIS measures are in place for 2007, including tracking of potentially harmful drug-disease interactions in the elderly.
And, for the first time, health plans are being asked to report on their use of resources in treating various conditions. In 2007, they were diabetes, asthma, and low back pain. In 2008, chronic obstructive pulmonary disease, hypertension, and cardiovascular disease have been added. These conditions account for 60% of health care spending, said Ms. O'Kane.
The data will be used to determine the variations in resource use among health plans.
Coupled with the HEDIS quality measures, the NCQA will eventually be able to rate which plans give the best quality care for the least amount of money, said Ms. O'Kane.
SCHIP Wins Extension Until 2009
After months of debate and two presidential vetoes, Congress has successfully voted to extend the State Children's Health Insurance Program to April 2009.
President Bush signed the legislation on Dec. 29. The SCHIP extension is included in a bill that also addressed Medicare physician reimbursement, payments for Part B drugs, lab tests used by diabetics, and long-term care hospitals.
Authorization for SCHIP expired Sept. 30. The program continued to operate through two continuing resolutions that kept the entire federal government funded until mid-December while lawmakers and the President wrangled over a 5-year reauthorization.
The showdown ended when the Senate and House both agreed to a stripped-down version of the Democrats' wish list. Congress voted to allocate enough funds to keep SCHIP enrollment at 2007 levels—about 6 million children and adults—through March 31, 2009. Democrats had sought to cover 10 million children.
And the bill provided enough funding to keep programs afloat in a handful of states that were facing budgetary shortfalls.
Democrats and child advocates were relieved the program was extended temporarily, but many expressed concern about SCHIP's future.
“Today we passed a package that puts a band-aid on Medicare and buys just a little more time for families currently relying on SCHIP to keep their children healthy,” Rep. Charles B. Rangel (D-N.Y.) said in a statement. “My concern with this legislation is not what's in it, but what's not in it.”
House Speaker Nancy Pelosi issued a statement noting the bill “does not make headway in reducing the number of uninsured.”
Some Republicans weren't happy, either. Sen. Charles Grassley (R-Iowa) said although the original bill was passed unanimously in the Senate, he knew it fell short of what many in Congress were hoping for. “I do hope we can do more when we come back next year,” he said in a statement.
The SCHIP package that was passed did not—as Democrats had preferred—reverse a directive issued by the Centers for Medicare and Medicaid Services last August. States were notified that if they were raising eligibility for children whose family incomes were equal to or above 250% of the federal poverty level, they would have to meet stringent new requirements. Primarily, states would have to prove that 95% of eligible children—those at 250% of poverty—were enrolled. The goal: to ensure that these families are not opting for SCHIP instead of private insurance.
States must meet that target by August 2008. In a briefing, Acting CMS Administrator Kerry Weems said at least two states, Vermont and Massachusetts, will soon meet the goal. Currently, there is no enforcement plan, he said.
In a conference call with reporters, Robert Greenstein, executive director of the Center on Budget and Policy Priorities, a liberal-leaning think tank in Washington, said that the directive could have a huge impact on enrollment. Fourteen states already cover children above 250% of poverty, and 10 more had plans to expand eligibility above that level.
Thus, the SCHIP bill “was not a maintenance of the current situation but backwards progress,” he said.
After months of debate and two presidential vetoes, Congress has successfully voted to extend the State Children's Health Insurance Program to April 2009.
President Bush signed the legislation on Dec. 29. The SCHIP extension is included in a bill that also addressed Medicare physician reimbursement, payments for Part B drugs, lab tests used by diabetics, and long-term care hospitals.
Authorization for SCHIP expired Sept. 30. The program continued to operate through two continuing resolutions that kept the entire federal government funded until mid-December while lawmakers and the President wrangled over a 5-year reauthorization.
The showdown ended when the Senate and House both agreed to a stripped-down version of the Democrats' wish list. Congress voted to allocate enough funds to keep SCHIP enrollment at 2007 levels—about 6 million children and adults—through March 31, 2009. Democrats had sought to cover 10 million children.
And the bill provided enough funding to keep programs afloat in a handful of states that were facing budgetary shortfalls.
Democrats and child advocates were relieved the program was extended temporarily, but many expressed concern about SCHIP's future.
“Today we passed a package that puts a band-aid on Medicare and buys just a little more time for families currently relying on SCHIP to keep their children healthy,” Rep. Charles B. Rangel (D-N.Y.) said in a statement. “My concern with this legislation is not what's in it, but what's not in it.”
House Speaker Nancy Pelosi issued a statement noting the bill “does not make headway in reducing the number of uninsured.”
Some Republicans weren't happy, either. Sen. Charles Grassley (R-Iowa) said although the original bill was passed unanimously in the Senate, he knew it fell short of what many in Congress were hoping for. “I do hope we can do more when we come back next year,” he said in a statement.
The SCHIP package that was passed did not—as Democrats had preferred—reverse a directive issued by the Centers for Medicare and Medicaid Services last August. States were notified that if they were raising eligibility for children whose family incomes were equal to or above 250% of the federal poverty level, they would have to meet stringent new requirements. Primarily, states would have to prove that 95% of eligible children—those at 250% of poverty—were enrolled. The goal: to ensure that these families are not opting for SCHIP instead of private insurance.
States must meet that target by August 2008. In a briefing, Acting CMS Administrator Kerry Weems said at least two states, Vermont and Massachusetts, will soon meet the goal. Currently, there is no enforcement plan, he said.
In a conference call with reporters, Robert Greenstein, executive director of the Center on Budget and Policy Priorities, a liberal-leaning think tank in Washington, said that the directive could have a huge impact on enrollment. Fourteen states already cover children above 250% of poverty, and 10 more had plans to expand eligibility above that level.
Thus, the SCHIP bill “was not a maintenance of the current situation but backwards progress,” he said.
After months of debate and two presidential vetoes, Congress has successfully voted to extend the State Children's Health Insurance Program to April 2009.
President Bush signed the legislation on Dec. 29. The SCHIP extension is included in a bill that also addressed Medicare physician reimbursement, payments for Part B drugs, lab tests used by diabetics, and long-term care hospitals.
Authorization for SCHIP expired Sept. 30. The program continued to operate through two continuing resolutions that kept the entire federal government funded until mid-December while lawmakers and the President wrangled over a 5-year reauthorization.
The showdown ended when the Senate and House both agreed to a stripped-down version of the Democrats' wish list. Congress voted to allocate enough funds to keep SCHIP enrollment at 2007 levels—about 6 million children and adults—through March 31, 2009. Democrats had sought to cover 10 million children.
And the bill provided enough funding to keep programs afloat in a handful of states that were facing budgetary shortfalls.
Democrats and child advocates were relieved the program was extended temporarily, but many expressed concern about SCHIP's future.
“Today we passed a package that puts a band-aid on Medicare and buys just a little more time for families currently relying on SCHIP to keep their children healthy,” Rep. Charles B. Rangel (D-N.Y.) said in a statement. “My concern with this legislation is not what's in it, but what's not in it.”
House Speaker Nancy Pelosi issued a statement noting the bill “does not make headway in reducing the number of uninsured.”
Some Republicans weren't happy, either. Sen. Charles Grassley (R-Iowa) said although the original bill was passed unanimously in the Senate, he knew it fell short of what many in Congress were hoping for. “I do hope we can do more when we come back next year,” he said in a statement.
The SCHIP package that was passed did not—as Democrats had preferred—reverse a directive issued by the Centers for Medicare and Medicaid Services last August. States were notified that if they were raising eligibility for children whose family incomes were equal to or above 250% of the federal poverty level, they would have to meet stringent new requirements. Primarily, states would have to prove that 95% of eligible children—those at 250% of poverty—were enrolled. The goal: to ensure that these families are not opting for SCHIP instead of private insurance.
States must meet that target by August 2008. In a briefing, Acting CMS Administrator Kerry Weems said at least two states, Vermont and Massachusetts, will soon meet the goal. Currently, there is no enforcement plan, he said.
In a conference call with reporters, Robert Greenstein, executive director of the Center on Budget and Policy Priorities, a liberal-leaning think tank in Washington, said that the directive could have a huge impact on enrollment. Fourteen states already cover children above 250% of poverty, and 10 more had plans to expand eligibility above that level.
Thus, the SCHIP bill “was not a maintenance of the current situation but backwards progress,” he said.
New DEA Rule Allows Multiple Prescriptions for Pain Drugs
In a reversal, the Drug Enforcement Administration will now allow physicians to write up to three prescriptions for a 90-day supply of schedule II controlled substances.
The final rule, published in November, is viewed as a victory by pain medicine specialists, said Dr. B. Todd Sitzman, American Academy of Pain Medicine president and director of advanced pain therapy at the Forrest General Hospital's cancer center in Hattiesburg, Miss.
“It's an indication that [DEA officials] have listened to pain physicians and to the pain patient community,” he said in an interview.
The rule overturns an interim policy that prohibited the dispensing of multiple prescriptions at a single office visit and clarifies the DEA's expectations, said Dr. Sitzman.
Under the new policy, physicians may write prescriptions labeled “do not fill until,” with a preset date. This means patients can get a new prescription every 30 days, for 3 months, without having to return to the physician's office.
The prescriptions do not qualify as refills. They still must be taken to a pharmacy to be filled. DEA also said that the 90-day limit is the maximum according to its interpretation of congressional intent and the statute covering schedule II controlled substances.
In the rule, the DEA addressed several areas of concern to prescribing physicians.
The agency said it “wishes to dispel the mistaken notion among a small number of medical professionals that the agency has embarked on a campaign to 'target' physicians who prescribe controlled substances for the treatment of pain (or that physicians must curb their legitimate prescribing of pain medications to avoid legal liability).”
The agency noted that in any given year, fewer than 1 in 10,000 physicians lose their controlled substance registration because of a DEA investigation.
But, added the agency, the rule does not alter longstanding state and federal requirements that controlled substances can only be prescribed, administered or dispensed for a legitimate medical purpose by a physician acting in the usual course of professional practice.
The changes were first proposed in 2006, when the DEA was asked by commenters to issue specific guidance on how a clinician could assess pain, when a physician should prescribe an opioid, or how to use opioids.
But the agency said it would not do so, noting it does not regulate the practice of medicine and these topics are better addressed by professional organizations, medical schools, and postgraduate medical training.
Dr. Sitzman said the lack of strict guidelines is a positive thing.
Other organizations were also heartened by the rule change. In a statement, Dr. Rebecca Patchin, an American Medical Association board member, said the change “will give patients better access to the prescription drugs they need and continue to minimize the risks controlled substances pose to public health and safety.”
In a reversal, the Drug Enforcement Administration will now allow physicians to write up to three prescriptions for a 90-day supply of schedule II controlled substances.
The final rule, published in November, is viewed as a victory by pain medicine specialists, said Dr. B. Todd Sitzman, American Academy of Pain Medicine president and director of advanced pain therapy at the Forrest General Hospital's cancer center in Hattiesburg, Miss.
“It's an indication that [DEA officials] have listened to pain physicians and to the pain patient community,” he said in an interview.
The rule overturns an interim policy that prohibited the dispensing of multiple prescriptions at a single office visit and clarifies the DEA's expectations, said Dr. Sitzman.
Under the new policy, physicians may write prescriptions labeled “do not fill until,” with a preset date. This means patients can get a new prescription every 30 days, for 3 months, without having to return to the physician's office.
The prescriptions do not qualify as refills. They still must be taken to a pharmacy to be filled. DEA also said that the 90-day limit is the maximum according to its interpretation of congressional intent and the statute covering schedule II controlled substances.
In the rule, the DEA addressed several areas of concern to prescribing physicians.
The agency said it “wishes to dispel the mistaken notion among a small number of medical professionals that the agency has embarked on a campaign to 'target' physicians who prescribe controlled substances for the treatment of pain (or that physicians must curb their legitimate prescribing of pain medications to avoid legal liability).”
The agency noted that in any given year, fewer than 1 in 10,000 physicians lose their controlled substance registration because of a DEA investigation.
But, added the agency, the rule does not alter longstanding state and federal requirements that controlled substances can only be prescribed, administered or dispensed for a legitimate medical purpose by a physician acting in the usual course of professional practice.
The changes were first proposed in 2006, when the DEA was asked by commenters to issue specific guidance on how a clinician could assess pain, when a physician should prescribe an opioid, or how to use opioids.
But the agency said it would not do so, noting it does not regulate the practice of medicine and these topics are better addressed by professional organizations, medical schools, and postgraduate medical training.
Dr. Sitzman said the lack of strict guidelines is a positive thing.
Other organizations were also heartened by the rule change. In a statement, Dr. Rebecca Patchin, an American Medical Association board member, said the change “will give patients better access to the prescription drugs they need and continue to minimize the risks controlled substances pose to public health and safety.”
In a reversal, the Drug Enforcement Administration will now allow physicians to write up to three prescriptions for a 90-day supply of schedule II controlled substances.
The final rule, published in November, is viewed as a victory by pain medicine specialists, said Dr. B. Todd Sitzman, American Academy of Pain Medicine president and director of advanced pain therapy at the Forrest General Hospital's cancer center in Hattiesburg, Miss.
“It's an indication that [DEA officials] have listened to pain physicians and to the pain patient community,” he said in an interview.
The rule overturns an interim policy that prohibited the dispensing of multiple prescriptions at a single office visit and clarifies the DEA's expectations, said Dr. Sitzman.
Under the new policy, physicians may write prescriptions labeled “do not fill until,” with a preset date. This means patients can get a new prescription every 30 days, for 3 months, without having to return to the physician's office.
The prescriptions do not qualify as refills. They still must be taken to a pharmacy to be filled. DEA also said that the 90-day limit is the maximum according to its interpretation of congressional intent and the statute covering schedule II controlled substances.
In the rule, the DEA addressed several areas of concern to prescribing physicians.
The agency said it “wishes to dispel the mistaken notion among a small number of medical professionals that the agency has embarked on a campaign to 'target' physicians who prescribe controlled substances for the treatment of pain (or that physicians must curb their legitimate prescribing of pain medications to avoid legal liability).”
The agency noted that in any given year, fewer than 1 in 10,000 physicians lose their controlled substance registration because of a DEA investigation.
But, added the agency, the rule does not alter longstanding state and federal requirements that controlled substances can only be prescribed, administered or dispensed for a legitimate medical purpose by a physician acting in the usual course of professional practice.
The changes were first proposed in 2006, when the DEA was asked by commenters to issue specific guidance on how a clinician could assess pain, when a physician should prescribe an opioid, or how to use opioids.
But the agency said it would not do so, noting it does not regulate the practice of medicine and these topics are better addressed by professional organizations, medical schools, and postgraduate medical training.
Dr. Sitzman said the lack of strict guidelines is a positive thing.
Other organizations were also heartened by the rule change. In a statement, Dr. Rebecca Patchin, an American Medical Association board member, said the change “will give patients better access to the prescription drugs they need and continue to minimize the risks controlled substances pose to public health and safety.”
Congress Buys Some Time, Extends SCHIP Until 2009
After months of debate and two presidential vetoes, Congress has successfully voted to extend the State Children's Health Insurance Program to April 2009.
President Bush signed the legislation on December 29th. The law containing the SCHIP extension also addressed Medicare physician reimbursement, payments for Part B drugs, lab tests used by diabetics, and long-term care hospitals.
Authorization for SCHIP expired Sept. 30. The program continued to operate through two resolutions that kept the entire federal government funded until December while lawmakers and President Bush wrangled over a 5-year reauthorization. The showdown ended in December when the Senate and House both agreed to a stripped-down version of the Democrats' wish list. Congress allocated enough federal funds to keep SCHIP enrollment at 2007 levels—or about 6 million children and adults—through March 31, 2009. Democrats sought to cover 10 million children.
“Today we passed a package that puts a band-aid on Medicare and buys just a little more time for families currently relying on SCHIP,” Rep. Charles B. Rangel (D-N.Y.) said in a statement.
Also in a statement, House Speaker Nancy Pelosi said the bill “does not make headway in reducing the number of uninsured.” Sen. Charles Grassley (R-Iowa) said although the original bill was passed unanimously in the Senate, he knew it fell short of what many in Congress were hoping for.
The SCHIP package that was passed did not—as Democrats had preferred—reverse a directive issued by the Centers for Medicare and Medicaid Services last August. States were notified that if they were raising eligibility for children whose family incomes were equal to or above 250% of the federal poverty level, they would have to meet stringent new requirements proving that 95% of eligible children—those at 250% of poverty—were enrolled. The goal: to ensure these families are not opting for SCHIP instead of private insurance.
States must meet that target by August 2008. In a briefing with reporters, Acting CMS Administrator Kerry Weems said at least two states, Vermont and Massachusetts, will soon meet the goal.
In a conference call, Robert Greenstein, executive director of the Center on Budget and Policy Priorities, a liberal-leaning think tank in Washington, said the directive could have a huge impact on enrollment. Fourteen states already cover children above 250% of poverty, and 10 more had plans to expand eligibility above that level.
Thus, the SCHIP bill “was not a maintenance of the current situation but backwards progress,” he said.
After months of debate and two presidential vetoes, Congress has successfully voted to extend the State Children's Health Insurance Program to April 2009.
President Bush signed the legislation on December 29th. The law containing the SCHIP extension also addressed Medicare physician reimbursement, payments for Part B drugs, lab tests used by diabetics, and long-term care hospitals.
Authorization for SCHIP expired Sept. 30. The program continued to operate through two resolutions that kept the entire federal government funded until December while lawmakers and President Bush wrangled over a 5-year reauthorization. The showdown ended in December when the Senate and House both agreed to a stripped-down version of the Democrats' wish list. Congress allocated enough federal funds to keep SCHIP enrollment at 2007 levels—or about 6 million children and adults—through March 31, 2009. Democrats sought to cover 10 million children.
“Today we passed a package that puts a band-aid on Medicare and buys just a little more time for families currently relying on SCHIP,” Rep. Charles B. Rangel (D-N.Y.) said in a statement.
Also in a statement, House Speaker Nancy Pelosi said the bill “does not make headway in reducing the number of uninsured.” Sen. Charles Grassley (R-Iowa) said although the original bill was passed unanimously in the Senate, he knew it fell short of what many in Congress were hoping for.
The SCHIP package that was passed did not—as Democrats had preferred—reverse a directive issued by the Centers for Medicare and Medicaid Services last August. States were notified that if they were raising eligibility for children whose family incomes were equal to or above 250% of the federal poverty level, they would have to meet stringent new requirements proving that 95% of eligible children—those at 250% of poverty—were enrolled. The goal: to ensure these families are not opting for SCHIP instead of private insurance.
States must meet that target by August 2008. In a briefing with reporters, Acting CMS Administrator Kerry Weems said at least two states, Vermont and Massachusetts, will soon meet the goal.
In a conference call, Robert Greenstein, executive director of the Center on Budget and Policy Priorities, a liberal-leaning think tank in Washington, said the directive could have a huge impact on enrollment. Fourteen states already cover children above 250% of poverty, and 10 more had plans to expand eligibility above that level.
Thus, the SCHIP bill “was not a maintenance of the current situation but backwards progress,” he said.
After months of debate and two presidential vetoes, Congress has successfully voted to extend the State Children's Health Insurance Program to April 2009.
President Bush signed the legislation on December 29th. The law containing the SCHIP extension also addressed Medicare physician reimbursement, payments for Part B drugs, lab tests used by diabetics, and long-term care hospitals.
Authorization for SCHIP expired Sept. 30. The program continued to operate through two resolutions that kept the entire federal government funded until December while lawmakers and President Bush wrangled over a 5-year reauthorization. The showdown ended in December when the Senate and House both agreed to a stripped-down version of the Democrats' wish list. Congress allocated enough federal funds to keep SCHIP enrollment at 2007 levels—or about 6 million children and adults—through March 31, 2009. Democrats sought to cover 10 million children.
“Today we passed a package that puts a band-aid on Medicare and buys just a little more time for families currently relying on SCHIP,” Rep. Charles B. Rangel (D-N.Y.) said in a statement.
Also in a statement, House Speaker Nancy Pelosi said the bill “does not make headway in reducing the number of uninsured.” Sen. Charles Grassley (R-Iowa) said although the original bill was passed unanimously in the Senate, he knew it fell short of what many in Congress were hoping for.
The SCHIP package that was passed did not—as Democrats had preferred—reverse a directive issued by the Centers for Medicare and Medicaid Services last August. States were notified that if they were raising eligibility for children whose family incomes were equal to or above 250% of the federal poverty level, they would have to meet stringent new requirements proving that 95% of eligible children—those at 250% of poverty—were enrolled. The goal: to ensure these families are not opting for SCHIP instead of private insurance.
States must meet that target by August 2008. In a briefing with reporters, Acting CMS Administrator Kerry Weems said at least two states, Vermont and Massachusetts, will soon meet the goal.
In a conference call, Robert Greenstein, executive director of the Center on Budget and Policy Priorities, a liberal-leaning think tank in Washington, said the directive could have a huge impact on enrollment. Fourteen states already cover children above 250% of poverty, and 10 more had plans to expand eligibility above that level.
Thus, the SCHIP bill “was not a maintenance of the current situation but backwards progress,” he said.
E-Prescribing Standards Proposed
The Health and Human Services department has proposed federal e-prescribing standards to be used for Medicare participating physicians, pharmacists, and software vendors.
The proposal was issued November 16; comments are being accepted through mid-January.
E-prescribing is not required for participation in the Medicare Part D drug benefit. But under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003—the law that established the benefit—drug plans, physicians, and pharmacists who use electronic prescribing are required to meet the HHS standards.
Some organizations have pushed for required e-prescribing for Medicare participation. The Pharmaceutical Care Management Association (PCMA), which represents pharmacy benefit managers, is spearheading the effort.
The organization launched a print and broadcast ad campaign in November that called for adoption of e-prescribing by 2010—the same deadline set by the Institute of Medicine in a report on reducing adverse drug reactions that was issued in July 2006.
The American Health Information Community has also urged the HHS to require e-prescribing for Medicare.
The American Medical Association and other groups oppose a mandate.
“From a practical side, a mandate would be premature,” said Stacey Swartz, Pharm.D., senior director of pharmacy affairs at the National Community Pharmacists Association, in an interview.
“We can see the benefits of it, but we can't ignore that there are costs involved,” she added.
The final e-prescribing standards should be issued by April 1, 2008.
The Health and Human Services department has proposed federal e-prescribing standards to be used for Medicare participating physicians, pharmacists, and software vendors.
The proposal was issued November 16; comments are being accepted through mid-January.
E-prescribing is not required for participation in the Medicare Part D drug benefit. But under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003—the law that established the benefit—drug plans, physicians, and pharmacists who use electronic prescribing are required to meet the HHS standards.
Some organizations have pushed for required e-prescribing for Medicare participation. The Pharmaceutical Care Management Association (PCMA), which represents pharmacy benefit managers, is spearheading the effort.
The organization launched a print and broadcast ad campaign in November that called for adoption of e-prescribing by 2010—the same deadline set by the Institute of Medicine in a report on reducing adverse drug reactions that was issued in July 2006.
The American Health Information Community has also urged the HHS to require e-prescribing for Medicare.
The American Medical Association and other groups oppose a mandate.
“From a practical side, a mandate would be premature,” said Stacey Swartz, Pharm.D., senior director of pharmacy affairs at the National Community Pharmacists Association, in an interview.
“We can see the benefits of it, but we can't ignore that there are costs involved,” she added.
The final e-prescribing standards should be issued by April 1, 2008.
The Health and Human Services department has proposed federal e-prescribing standards to be used for Medicare participating physicians, pharmacists, and software vendors.
The proposal was issued November 16; comments are being accepted through mid-January.
E-prescribing is not required for participation in the Medicare Part D drug benefit. But under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003—the law that established the benefit—drug plans, physicians, and pharmacists who use electronic prescribing are required to meet the HHS standards.
Some organizations have pushed for required e-prescribing for Medicare participation. The Pharmaceutical Care Management Association (PCMA), which represents pharmacy benefit managers, is spearheading the effort.
The organization launched a print and broadcast ad campaign in November that called for adoption of e-prescribing by 2010—the same deadline set by the Institute of Medicine in a report on reducing adverse drug reactions that was issued in July 2006.
The American Health Information Community has also urged the HHS to require e-prescribing for Medicare.
The American Medical Association and other groups oppose a mandate.
“From a practical side, a mandate would be premature,” said Stacey Swartz, Pharm.D., senior director of pharmacy affairs at the National Community Pharmacists Association, in an interview.
“We can see the benefits of it, but we can't ignore that there are costs involved,” she added.
The final e-prescribing standards should be issued by April 1, 2008.
E-Prescribing Standards Proposed
The Health and Human Services department has proposed federal e-prescribing standards to be used for Medicare participating physicians, pharmacists, and software vendors.
The proposal was issued last month; comments are being accepted through mid-January, and the final e-prescribing standards should be issued by April 1.
E-prescribing is not required for participation in the Medicare Part D drug benefit. But under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, drug plans, physicians, and pharmacists who use electronic prescribing are required to meet the HHS standards.
Some organizations have pushed for required e-prescribing for Medicare participation. The Pharmaceutical Care Management Association (PCMA), which represents pharmacy benefit managers, is spearheading the effort. The organization launched a print and broadcast ad campaign in November that called for adoption of e-prescribing by 2010—the same deadline set by the Institute of Medicine in a report on reducing adverse drug reactions that was issued in July 2006.
The American Medical Association and other groups oppose a mandate. “From a practical side, a mandate would be premature,” Stacey Swartz, Pharm.D., senior director of pharmacy affairs at the National Community Pharmacists Association, said in an interview. “We can see the benefits of it, but we can't ignore that there are costs involved.”
The Health and Human Services department has proposed federal e-prescribing standards to be used for Medicare participating physicians, pharmacists, and software vendors.
The proposal was issued last month; comments are being accepted through mid-January, and the final e-prescribing standards should be issued by April 1.
E-prescribing is not required for participation in the Medicare Part D drug benefit. But under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, drug plans, physicians, and pharmacists who use electronic prescribing are required to meet the HHS standards.
Some organizations have pushed for required e-prescribing for Medicare participation. The Pharmaceutical Care Management Association (PCMA), which represents pharmacy benefit managers, is spearheading the effort. The organization launched a print and broadcast ad campaign in November that called for adoption of e-prescribing by 2010—the same deadline set by the Institute of Medicine in a report on reducing adverse drug reactions that was issued in July 2006.
The American Medical Association and other groups oppose a mandate. “From a practical side, a mandate would be premature,” Stacey Swartz, Pharm.D., senior director of pharmacy affairs at the National Community Pharmacists Association, said in an interview. “We can see the benefits of it, but we can't ignore that there are costs involved.”
The Health and Human Services department has proposed federal e-prescribing standards to be used for Medicare participating physicians, pharmacists, and software vendors.
The proposal was issued last month; comments are being accepted through mid-January, and the final e-prescribing standards should be issued by April 1.
E-prescribing is not required for participation in the Medicare Part D drug benefit. But under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, drug plans, physicians, and pharmacists who use electronic prescribing are required to meet the HHS standards.
Some organizations have pushed for required e-prescribing for Medicare participation. The Pharmaceutical Care Management Association (PCMA), which represents pharmacy benefit managers, is spearheading the effort. The organization launched a print and broadcast ad campaign in November that called for adoption of e-prescribing by 2010—the same deadline set by the Institute of Medicine in a report on reducing adverse drug reactions that was issued in July 2006.
The American Medical Association and other groups oppose a mandate. “From a practical side, a mandate would be premature,” Stacey Swartz, Pharm.D., senior director of pharmacy affairs at the National Community Pharmacists Association, said in an interview. “We can see the benefits of it, but we can't ignore that there are costs involved.”