Alicia Ault

WASHINGTON – Flat funding over the last decade combined with inflation has effectively cut 20% out of the research budget for the National Institutes of Health – and now another 5% is gone thanks to the federal budget sequester.

Cancer researchers, practicing oncologists, advocates, and congressional supporters took a break from the annual meeting of the American Association for Cancer Research to protest the long and lingering decline in funding. They were joined at the Rally for Medical Research by representatives from at least 200 partner organizations involved in research, patient care, or advocacy for diabetes, heart disease, stroke, Alzheimer’s disease, and AIDS, among other conditions.

Even President Obama chimed in via a message read by Dr. Margaret Foti, AACR chief executive officer.

"By investing in the best ideas and supporting the work of our scientists, we will improve health and change lives in ways we could have never imagined," read Dr. Foti from the president’s remarks.

In her own remarks, Dr. Foti said that just showing up was important to the greater goal. "By participating in today’s rally, you are taking a very important step to ensure that America will continue to lead the world in medical research," she said.

The rally focused on the cuts to funding for the 27 institutes and centers at the National Institutes of Health. The NIH is currently funded at $30.6 billion, which makes it biggest supporter of medical research in the world, according to rally organizers. But, they said, NIH appropriations have been flat since 2003. Factoring in biomedical inflation, the agency has effectively lost approximately $6 billion, or 20% of its purchasing power over that same time period. Sequestration threatens another 5%, or $5 billion cut.

Rep. Rosa DeLauro (D-Conn.), an ovarian cancer survivor, said at the rally that biomedical research helps grow the economy. "Every dollar that goes to the NIH results in $2 of business activity," she said, calling on rally participants to visit their congressional delegations and urge them to take money from other programs to balance the budget.

Rep. Chris Van Hollen (D-Md.), is whose district NIH is headquartered, said that continued cuts to biomedical funding could deter young people from pursuing careers in science.

"We should not be retreating on medical research, we should be redoubling our efforts," said Rep. Van Hollen, who serves as ranking member on the House Budget Committee.

Rep. Van Hollen said he hoped the rally would bring a sharper focus to the impact of the sequester. "The more public attention we draw to this issue, the better chance we’ll have at replacing the sequester," he said in an interview. "This is one area that has consequences for people of every political persuasion."

The sequester cuts are being felt already, according to Candace Johnson, Ph.D., deputy director of the Roswell Park Cancer Institute, Buffalo, N.Y. The institute could lose at least $8 million from its overall budget of $550 million, but the cuts will fall disproportionately on the research programs, Dr. Johnson said in an interview. And there’s continued uncertainty with the sequester – it is possible that some grants will be cut even more than anticipated. "We’re in the dark here," she said.

Cutting research will also have an effect on clinical care, Dr. Johnson said. "When you cut basic science, you cut that road to better and more innovative clinical care. If you don’t have basic science, you don’t have cancer centers doing basic discovery, then you don’t have a phase I program."

Dr. Sandra Swain, president of the American Society of Clinical Oncology, said that sustained and predictable funding increases were crucial to progress. And she noted, there’s no substitute for federal funds. "While private industry is a strong partner in cancer research, public funding is essential to pursue the types of research in which industry may have no interest," she said, in a statement. "This is particularly true for rare diseases, combinations of different companies’ products, therapies with multiple treatment modalities (such as surgery, radiation, and chemotherapy), and direct comparisons of company products," Dr. Swain said.

ASCO also sounded a note of caution about the budget for the Food and Drug Administration, which is also cut under sequestration. ASCO "is concerned that sequestration will cause slower approval of new and potentially life-saving drugs, difficulty in meeting challenges in monitoring of food and drug safety, and an inability to keep up with advancing science and technology," Dr. Swain said.

[email protected]

On Twitter @aliciaault

WASHINGTON – Flat funding over the last decade combined with inflation has effectively cut 20% out of the research budget for the National Institutes of Health – and now another 5% is gone thanks to the federal budget sequester.

Cancer researchers, practicing oncologists, advocates, and congressional supporters took a break from the annual meeting of the American Association for Cancer Research to protest the long and lingering decline in funding. They were joined at the Rally for Medical Research by representatives from at least 200 partner organizations involved in research, patient care, or advocacy for diabetes, heart disease, stroke, Alzheimer’s disease, and AIDS, among other conditions.

Even President Obama chimed in via a message read by Dr. Margaret Foti, AACR chief executive officer.

"By investing in the best ideas and supporting the work of our scientists, we will improve health and change lives in ways we could have never imagined," read Dr. Foti from the president’s remarks.

In her own remarks, Dr. Foti said that just showing up was important to the greater goal. "By participating in today’s rally, you are taking a very important step to ensure that America will continue to lead the world in medical research," she said.

The rally focused on the cuts to funding for the 27 institutes and centers at the National Institutes of Health. The NIH is currently funded at $30.6 billion, which makes it biggest supporter of medical research in the world, according to rally organizers. But, they said, NIH appropriations have been flat since 2003. Factoring in biomedical inflation, the agency has effectively lost approximately $6 billion, or 20% of its purchasing power over that same time period. Sequestration threatens another 5%, or $5 billion cut.

Rep. Rosa DeLauro (D-Conn.), an ovarian cancer survivor, said at the rally that biomedical research helps grow the economy. "Every dollar that goes to the NIH results in $2 of business activity," she said, calling on rally participants to visit their congressional delegations and urge them to take money from other programs to balance the budget.

Rep. Chris Van Hollen (D-Md.), is whose district NIH is headquartered, said that continued cuts to biomedical funding could deter young people from pursuing careers in science.

"We should not be retreating on medical research, we should be redoubling our efforts," said Rep. Van Hollen, who serves as ranking member on the House Budget Committee.

Rep. Van Hollen said he hoped the rally would bring a sharper focus to the impact of the sequester. "The more public attention we draw to this issue, the better chance we’ll have at replacing the sequester," he said in an interview. "This is one area that has consequences for people of every political persuasion."

The sequester cuts are being felt already, according to Candace Johnson, Ph.D., deputy director of the Roswell Park Cancer Institute, Buffalo, N.Y. The institute could lose at least $8 million from its overall budget of $550 million, but the cuts will fall disproportionately on the research programs, Dr. Johnson said in an interview. And there’s continued uncertainty with the sequester – it is possible that some grants will be cut even more than anticipated. "We’re in the dark here," she said.

Cutting research will also have an effect on clinical care, Dr. Johnson said. "When you cut basic science, you cut that road to better and more innovative clinical care. If you don’t have basic science, you don’t have cancer centers doing basic discovery, then you don’t have a phase I program."

Dr. Sandra Swain, president of the American Society of Clinical Oncology, said that sustained and predictable funding increases were crucial to progress. And she noted, there’s no substitute for federal funds. "While private industry is a strong partner in cancer research, public funding is essential to pursue the types of research in which industry may have no interest," she said, in a statement. "This is particularly true for rare diseases, combinations of different companies’ products, therapies with multiple treatment modalities (such as surgery, radiation, and chemotherapy), and direct comparisons of company products," Dr. Swain said.

ASCO also sounded a note of caution about the budget for the Food and Drug Administration, which is also cut under sequestration. ASCO "is concerned that sequestration will cause slower approval of new and potentially life-saving drugs, difficulty in meeting challenges in monitoring of food and drug safety, and an inability to keep up with advancing science and technology," Dr. Swain said.

[email protected]

On Twitter @aliciaault

WASHINGTON – Flat funding over the last decade combined with inflation has effectively cut 20% out of the research budget for the National Institutes of Health – and now another 5% is gone thanks to the federal budget sequester.

Cancer researchers, practicing oncologists, advocates, and congressional supporters took a break from the annual meeting of the American Association for Cancer Research to protest the long and lingering decline in funding. They were joined at the Rally for Medical Research by representatives from at least 200 partner organizations involved in research, patient care, or advocacy for diabetes, heart disease, stroke, Alzheimer’s disease, and AIDS, among other conditions.

Even President Obama chimed in via a message read by Dr. Margaret Foti, AACR chief executive officer.

"By investing in the best ideas and supporting the work of our scientists, we will improve health and change lives in ways we could have never imagined," read Dr. Foti from the president’s remarks.

In her own remarks, Dr. Foti said that just showing up was important to the greater goal. "By participating in today’s rally, you are taking a very important step to ensure that America will continue to lead the world in medical research," she said.

The rally focused on the cuts to funding for the 27 institutes and centers at the National Institutes of Health. The NIH is currently funded at $30.6 billion, which makes it biggest supporter of medical research in the world, according to rally organizers. But, they said, NIH appropriations have been flat since 2003. Factoring in biomedical inflation, the agency has effectively lost approximately $6 billion, or 20% of its purchasing power over that same time period. Sequestration threatens another 5%, or $5 billion cut.

Rep. Rosa DeLauro (D-Conn.), an ovarian cancer survivor, said at the rally that biomedical research helps grow the economy. "Every dollar that goes to the NIH results in $2 of business activity," she said, calling on rally participants to visit their congressional delegations and urge them to take money from other programs to balance the budget.

Rep. Chris Van Hollen (D-Md.), is whose district NIH is headquartered, said that continued cuts to biomedical funding could deter young people from pursuing careers in science.

"We should not be retreating on medical research, we should be redoubling our efforts," said Rep. Van Hollen, who serves as ranking member on the House Budget Committee.

Rep. Van Hollen said he hoped the rally would bring a sharper focus to the impact of the sequester. "The more public attention we draw to this issue, the better chance we’ll have at replacing the sequester," he said in an interview. "This is one area that has consequences for people of every political persuasion."

The sequester cuts are being felt already, according to Candace Johnson, Ph.D., deputy director of the Roswell Park Cancer Institute, Buffalo, N.Y. The institute could lose at least $8 million from its overall budget of $550 million, but the cuts will fall disproportionately on the research programs, Dr. Johnson said in an interview. And there’s continued uncertainty with the sequester – it is possible that some grants will be cut even more than anticipated. "We’re in the dark here," she said.

Cutting research will also have an effect on clinical care, Dr. Johnson said. "When you cut basic science, you cut that road to better and more innovative clinical care. If you don’t have basic science, you don’t have cancer centers doing basic discovery, then you don’t have a phase I program."

Dr. Sandra Swain, president of the American Society of Clinical Oncology, said that sustained and predictable funding increases were crucial to progress. And she noted, there’s no substitute for federal funds. "While private industry is a strong partner in cancer research, public funding is essential to pursue the types of research in which industry may have no interest," she said, in a statement. "This is particularly true for rare diseases, combinations of different companies’ products, therapies with multiple treatment modalities (such as surgery, radiation, and chemotherapy), and direct comparisons of company products," Dr. Swain said.

ASCO also sounded a note of caution about the budget for the Food and Drug Administration, which is also cut under sequestration. ASCO "is concerned that sequestration will cause slower approval of new and potentially life-saving drugs, difficulty in meeting challenges in monitoring of food and drug safety, and an inability to keep up with advancing science and technology," Dr. Swain said.

[email protected]

On Twitter @aliciaault

Several organizations representing gay, lesbian, and transgender people have filed an administrative challenge seeking to overturn Medicare’s 32-year-old prohibition on coverage of sex reassignment surgery.

"This administrative challenge is being considered and working its way through the proper administrative channels," a spokesman for the Centers for Medicare and Medicaid Services said.

The American Civil Liberties Union, Gay & Lesbian Advocates & Defenders, the National Center for Lesbian Rights, and civil rights attorney Mary Lou Boelcke filed the challenge on March 26 on behalf of Denee Mallon, "a transgender woman whose doctors have recommended surgery to alleviate her severe gender dysphoria," according to a statement.

"Medicare’s categorical exclusion of this care lacks any scientific basis," said NCLR legal director Shannon Minter, in the statement. "Study after study has shown that these surgeries are the only effective treatment for many patients suffering from severe gender dysphoria."

Joshua Block, a staff attorney with the ACLU Lesbian Gay Bisexual Transgender Project, noted that "the American Medical Association, the Endocrine Society, and the American Psychological Society all support these treatments for transgender patients." He added, "These procedures have been performed for decades and are proven to be safe and effective."

The AMA House of Delegates adopted a resolution in 2008 advocating private and public health insurance coverage for treatment of gender identity disorder, as recommended by a physician. The American Psychological Association’s Council of Representatives adopted a policy statement the same year that, among other things, advocated adequate mental and physical health care for transgender and gender variant individuals. The Endocrine Society approved guidelines for transgender care in 2009.

In 2012, the American Psychiatric Association’s Assembly approved a new policy backing public and private insurance coverage of gender transition treatment, and opposing exclusions for medically necessary treatment for transgender and gender variant people.

Kenneth Zucker, Ph.D., chair of the DSM-5 Workgroup on Sexual and Gender Identity Disorders, said in an interview that "there’s considerable evidence that hormonal therapy and sex reassignment surgery is often the treatment of choice for adults with gender dysphoria who are carefully assessed." Dr. Zucker, psychologist in chief at the Centre for Addiction and Mental Health in Toronto, called that "beyond debate." The DSM-5, which is to be published in mid-May, will include gender dysphoria as a diagnosis.

But Dr. Zucker said that a diagnosis does not dictate the best practice or treatment for any individual patient. He added that gender dysphoria had existed as a diagnosis since the DSM-III was published in 1980; however, it previously was known by other terms.

Surgical and other medical treatment of gender dysphoria has lagged in the United States primarily because of a lack of insurance coverage, Dr. Zucker said.

"If Medicare endorses sex reassignment surgery as a treatment option for carefully evaluated patients and this was then taken up and supported by more private insurers, this would reduce barriers to care," he said.

"A decision by Medicare that this treatment is medically necessary and not experimental could impact other health coverage of this surgery," agreed Dr. Dan Karasic, clinical professor of psychiatry at the University of California, San Francisco. He said a Medicare policy change could benefit some, including those who are disabled by HIV or mental illness, and elderly patients with gender dysphoria. "The clear preponderance of the evidence and consensus of experts supports the medical necessity of surgical treatment for gender dysphoria," Dr. Karasic said in an interview.

Treatment for the gender dysphoria is covered in many countries with national health systems including the Netherlands, Belgium, and the United Kingdom, Dr. Zucker said.

Mr. Block of the ACLU notes that California, Oregon, the District of Columbia, and Colorado have issued regulations clarifying that private insurers cannot exclude transition-related health care from their coverage.

According to the Human Rights Campaign’s Corporate Equality Index, only 25% of Fortune 500 companies currently offer transgender inclusive health benefits. That is defined as equal health coverage for transgender individuals without exclusion for medically necessary care, without blanket exclusions, and based on the World Professional Association for Transgender Health Standards of Care.

The administrative challenge was filed with the departmental appeals board of the U.S. Health and Human Services department. Mr. Block of the ACLU said that the board will first weigh the evidence that was used to make the initial coverage decision in 1981. If it finds that the decision was not properly supported – or that developments have called into question the reasonableness of the decision – it will consider new evidence. The ACLU-led complaint included an expert declaration "that collects the contemporary evidence to show the national coverage decision lacks any scientific basis," Mr. Block said.

There appears to be no time limit on when the Appeals Board must make a decision, he said.

Coincidentally, the administration challenge was filed the same week that the CMS posted a notice that it would reopen its national coverage decision on sex reassignment surgery, which has been in place since 1981. The notice was subsequently removed.

"In light of the challenge, we are no longer reopening the national coverage determination for reconsideration," a CMS spokesman said.

Brian Moulton, legal director of the Human Rights Campaign, applauded the challenge.

"Regardless of the mechanism, we are pleased that CMS will be reviewing its outdated policy with regard to treatment related to gender transition and hope they will follow the mainstream medical opinion that public and private insurance programs should provide coverage for this medically necessary care," he said.

[email protected]

On Twitter @aliciaault

Several organizations representing gay, lesbian, and transgender people have filed an administrative challenge seeking to overturn Medicare’s 32-year-old prohibition on coverage of sex reassignment surgery.

"This administrative challenge is being considered and working its way through the proper administrative channels," a spokesman for the Centers for Medicare and Medicaid Services said.

The American Civil Liberties Union, Gay & Lesbian Advocates & Defenders, the National Center for Lesbian Rights, and civil rights attorney Mary Lou Boelcke filed the challenge on March 26 on behalf of Denee Mallon, "a transgender woman whose doctors have recommended surgery to alleviate her severe gender dysphoria," according to a statement.

"Medicare’s categorical exclusion of this care lacks any scientific basis," said NCLR legal director Shannon Minter, in the statement. "Study after study has shown that these surgeries are the only effective treatment for many patients suffering from severe gender dysphoria."

Joshua Block, a staff attorney with the ACLU Lesbian Gay Bisexual Transgender Project, noted that "the American Medical Association, the Endocrine Society, and the American Psychological Society all support these treatments for transgender patients." He added, "These procedures have been performed for decades and are proven to be safe and effective."

The AMA House of Delegates adopted a resolution in 2008 advocating private and public health insurance coverage for treatment of gender identity disorder, as recommended by a physician. The American Psychological Association’s Council of Representatives adopted a policy statement the same year that, among other things, advocated adequate mental and physical health care for transgender and gender variant individuals. The Endocrine Society approved guidelines for transgender care in 2009.

In 2012, the American Psychiatric Association’s Assembly approved a new policy backing public and private insurance coverage of gender transition treatment, and opposing exclusions for medically necessary treatment for transgender and gender variant people.

Kenneth Zucker, Ph.D., chair of the DSM-5 Workgroup on Sexual and Gender Identity Disorders, said in an interview that "there’s considerable evidence that hormonal therapy and sex reassignment surgery is often the treatment of choice for adults with gender dysphoria who are carefully assessed." Dr. Zucker, psychologist in chief at the Centre for Addiction and Mental Health in Toronto, called that "beyond debate." The DSM-5, which is to be published in mid-May, will include gender dysphoria as a diagnosis.

But Dr. Zucker said that a diagnosis does not dictate the best practice or treatment for any individual patient. He added that gender dysphoria had existed as a diagnosis since the DSM-III was published in 1980; however, it previously was known by other terms.

Surgical and other medical treatment of gender dysphoria has lagged in the United States primarily because of a lack of insurance coverage, Dr. Zucker said.

"If Medicare endorses sex reassignment surgery as a treatment option for carefully evaluated patients and this was then taken up and supported by more private insurers, this would reduce barriers to care," he said.

"A decision by Medicare that this treatment is medically necessary and not experimental could impact other health coverage of this surgery," agreed Dr. Dan Karasic, clinical professor of psychiatry at the University of California, San Francisco. He said a Medicare policy change could benefit some, including those who are disabled by HIV or mental illness, and elderly patients with gender dysphoria. "The clear preponderance of the evidence and consensus of experts supports the medical necessity of surgical treatment for gender dysphoria," Dr. Karasic said in an interview.

Treatment for the gender dysphoria is covered in many countries with national health systems including the Netherlands, Belgium, and the United Kingdom, Dr. Zucker said.

Mr. Block of the ACLU notes that California, Oregon, the District of Columbia, and Colorado have issued regulations clarifying that private insurers cannot exclude transition-related health care from their coverage.

According to the Human Rights Campaign’s Corporate Equality Index, only 25% of Fortune 500 companies currently offer transgender inclusive health benefits. That is defined as equal health coverage for transgender individuals without exclusion for medically necessary care, without blanket exclusions, and based on the World Professional Association for Transgender Health Standards of Care.

The administrative challenge was filed with the departmental appeals board of the U.S. Health and Human Services department. Mr. Block of the ACLU said that the board will first weigh the evidence that was used to make the initial coverage decision in 1981. If it finds that the decision was not properly supported – or that developments have called into question the reasonableness of the decision – it will consider new evidence. The ACLU-led complaint included an expert declaration "that collects the contemporary evidence to show the national coverage decision lacks any scientific basis," Mr. Block said.

There appears to be no time limit on when the Appeals Board must make a decision, he said.

Coincidentally, the administration challenge was filed the same week that the CMS posted a notice that it would reopen its national coverage decision on sex reassignment surgery, which has been in place since 1981. The notice was subsequently removed.

"In light of the challenge, we are no longer reopening the national coverage determination for reconsideration," a CMS spokesman said.

Brian Moulton, legal director of the Human Rights Campaign, applauded the challenge.

"Regardless of the mechanism, we are pleased that CMS will be reviewing its outdated policy with regard to treatment related to gender transition and hope they will follow the mainstream medical opinion that public and private insurance programs should provide coverage for this medically necessary care," he said.

[email protected]

On Twitter @aliciaault

Several organizations representing gay, lesbian, and transgender people have filed an administrative challenge seeking to overturn Medicare’s 32-year-old prohibition on coverage of sex reassignment surgery.

"This administrative challenge is being considered and working its way through the proper administrative channels," a spokesman for the Centers for Medicare and Medicaid Services said.

The American Civil Liberties Union, Gay & Lesbian Advocates & Defenders, the National Center for Lesbian Rights, and civil rights attorney Mary Lou Boelcke filed the challenge on March 26 on behalf of Denee Mallon, "a transgender woman whose doctors have recommended surgery to alleviate her severe gender dysphoria," according to a statement.

"Medicare’s categorical exclusion of this care lacks any scientific basis," said NCLR legal director Shannon Minter, in the statement. "Study after study has shown that these surgeries are the only effective treatment for many patients suffering from severe gender dysphoria."

Joshua Block, a staff attorney with the ACLU Lesbian Gay Bisexual Transgender Project, noted that "the American Medical Association, the Endocrine Society, and the American Psychological Society all support these treatments for transgender patients." He added, "These procedures have been performed for decades and are proven to be safe and effective."

The AMA House of Delegates adopted a resolution in 2008 advocating private and public health insurance coverage for treatment of gender identity disorder, as recommended by a physician. The American Psychological Association’s Council of Representatives adopted a policy statement the same year that, among other things, advocated adequate mental and physical health care for transgender and gender variant individuals. The Endocrine Society approved guidelines for transgender care in 2009.

In 2012, the American Psychiatric Association’s Assembly approved a new policy backing public and private insurance coverage of gender transition treatment, and opposing exclusions for medically necessary treatment for transgender and gender variant people.

Kenneth Zucker, Ph.D., chair of the DSM-5 Workgroup on Sexual and Gender Identity Disorders, said in an interview that "there’s considerable evidence that hormonal therapy and sex reassignment surgery is often the treatment of choice for adults with gender dysphoria who are carefully assessed." Dr. Zucker, psychologist in chief at the Centre for Addiction and Mental Health in Toronto, called that "beyond debate." The DSM-5, which is to be published in mid-May, will include gender dysphoria as a diagnosis.

But Dr. Zucker said that a diagnosis does not dictate the best practice or treatment for any individual patient. He added that gender dysphoria had existed as a diagnosis since the DSM-III was published in 1980; however, it previously was known by other terms.

Surgical and other medical treatment of gender dysphoria has lagged in the United States primarily because of a lack of insurance coverage, Dr. Zucker said.

"If Medicare endorses sex reassignment surgery as a treatment option for carefully evaluated patients and this was then taken up and supported by more private insurers, this would reduce barriers to care," he said.

"A decision by Medicare that this treatment is medically necessary and not experimental could impact other health coverage of this surgery," agreed Dr. Dan Karasic, clinical professor of psychiatry at the University of California, San Francisco. He said a Medicare policy change could benefit some, including those who are disabled by HIV or mental illness, and elderly patients with gender dysphoria. "The clear preponderance of the evidence and consensus of experts supports the medical necessity of surgical treatment for gender dysphoria," Dr. Karasic said in an interview.

Treatment for the gender dysphoria is covered in many countries with national health systems including the Netherlands, Belgium, and the United Kingdom, Dr. Zucker said.

Mr. Block of the ACLU notes that California, Oregon, the District of Columbia, and Colorado have issued regulations clarifying that private insurers cannot exclude transition-related health care from their coverage.

According to the Human Rights Campaign’s Corporate Equality Index, only 25% of Fortune 500 companies currently offer transgender inclusive health benefits. That is defined as equal health coverage for transgender individuals without exclusion for medically necessary care, without blanket exclusions, and based on the World Professional Association for Transgender Health Standards of Care.

The administrative challenge was filed with the departmental appeals board of the U.S. Health and Human Services department. Mr. Block of the ACLU said that the board will first weigh the evidence that was used to make the initial coverage decision in 1981. If it finds that the decision was not properly supported – or that developments have called into question the reasonableness of the decision – it will consider new evidence. The ACLU-led complaint included an expert declaration "that collects the contemporary evidence to show the national coverage decision lacks any scientific basis," Mr. Block said.

There appears to be no time limit on when the Appeals Board must make a decision, he said.

Coincidentally, the administration challenge was filed the same week that the CMS posted a notice that it would reopen its national coverage decision on sex reassignment surgery, which has been in place since 1981. The notice was subsequently removed.

"In light of the challenge, we are no longer reopening the national coverage determination for reconsideration," a CMS spokesman said.

Brian Moulton, legal director of the Human Rights Campaign, applauded the challenge.

"Regardless of the mechanism, we are pleased that CMS will be reviewing its outdated policy with regard to treatment related to gender transition and hope they will follow the mainstream medical opinion that public and private insurance programs should provide coverage for this medically necessary care," he said.

[email protected]

On Twitter @aliciaault

The Food and Drug Administration has approved canagliflozin, an oral, once-daily therapy for adult patients with type 2 diabetes.

The drug will be marketed by Janssen Pharmaceuticals as Invokana.

Canagliflozin is the first in a new class of medications known as selective sodium glucose cotransporter 2 (SGLT2) inhibitors; they act by blocking the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels in people with diabetes who have elevated blood glucose levels, the FDA said in a statement announcing the approval. Canagliflozin was recommended for approval by an FDA advisory panel in a 10-5 vote in January.

For the approval, Janssen submitted the results of nine phase III international studies in almost 10,300 patients, comparing the drug with placebo or active controls, as monotherapy and as add-on therapy to other antihyperglycemic drugs.

The company also submitted the interim results of a cardiovascular outcomes study, required by the FDA for all new type 2 diabetes drugs. In the outcomes study, there were more cardiovascular events in the canagliflozin-treated patients in the first 30 days, but the risk dropped after that to below the threshold set by the FDA as acceptable.

Still, the agency is requiring five postmarketing studies including a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes; a bone safety study; and two studies under the Pediatric Research Equity Act, which include a pharmacokinetic and pharmacodynamic study and a safety and efficacy study.

Canagliflozin’s most common side effects are vulvovaginal candidiasis and urinary tract infection. Use of the medication can also lead to orthostatic or postural hypotension; that side effect is most common in the first 3 months of therapy, according to the FDA.

The agency said that the drug should not be used in patients with type 1 diabetes, patients on dialysis, or in patients who have diabetic ketoacidosis, severe renal impairment, or end stage renal disease.

Several other SGLT2 inhibitors are in development, including ipragliflozin and empagliflozin. The FDA declined to approve dapagliflozin in 2012 because of safety concerns.

[email protected]

On Twitter @aliciaault

The Food and Drug Administration has approved canagliflozin, an oral, once-daily therapy for adult patients with type 2 diabetes.

The drug will be marketed by Janssen Pharmaceuticals as Invokana.

Canagliflozin is the first in a new class of medications known as selective sodium glucose cotransporter 2 (SGLT2) inhibitors; they act by blocking the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels in people with diabetes who have elevated blood glucose levels, the FDA said in a statement announcing the approval. Canagliflozin was recommended for approval by an FDA advisory panel in a 10-5 vote in January.

For the approval, Janssen submitted the results of nine phase III international studies in almost 10,300 patients, comparing the drug with placebo or active controls, as monotherapy and as add-on therapy to other antihyperglycemic drugs.

The company also submitted the interim results of a cardiovascular outcomes study, required by the FDA for all new type 2 diabetes drugs. In the outcomes study, there were more cardiovascular events in the canagliflozin-treated patients in the first 30 days, but the risk dropped after that to below the threshold set by the FDA as acceptable.

Still, the agency is requiring five postmarketing studies including a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes; a bone safety study; and two studies under the Pediatric Research Equity Act, which include a pharmacokinetic and pharmacodynamic study and a safety and efficacy study.

Canagliflozin’s most common side effects are vulvovaginal candidiasis and urinary tract infection. Use of the medication can also lead to orthostatic or postural hypotension; that side effect is most common in the first 3 months of therapy, according to the FDA.

The agency said that the drug should not be used in patients with type 1 diabetes, patients on dialysis, or in patients who have diabetic ketoacidosis, severe renal impairment, or end stage renal disease.

Several other SGLT2 inhibitors are in development, including ipragliflozin and empagliflozin. The FDA declined to approve dapagliflozin in 2012 because of safety concerns.

[email protected]

On Twitter @aliciaault

The Food and Drug Administration has approved canagliflozin, an oral, once-daily therapy for adult patients with type 2 diabetes.

The drug will be marketed by Janssen Pharmaceuticals as Invokana.

Canagliflozin is the first in a new class of medications known as selective sodium glucose cotransporter 2 (SGLT2) inhibitors; they act by blocking the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels in people with diabetes who have elevated blood glucose levels, the FDA said in a statement announcing the approval. Canagliflozin was recommended for approval by an FDA advisory panel in a 10-5 vote in January.

For the approval, Janssen submitted the results of nine phase III international studies in almost 10,300 patients, comparing the drug with placebo or active controls, as monotherapy and as add-on therapy to other antihyperglycemic drugs.

The company also submitted the interim results of a cardiovascular outcomes study, required by the FDA for all new type 2 diabetes drugs. In the outcomes study, there were more cardiovascular events in the canagliflozin-treated patients in the first 30 days, but the risk dropped after that to below the threshold set by the FDA as acceptable.

Still, the agency is requiring five postmarketing studies including a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes; a bone safety study; and two studies under the Pediatric Research Equity Act, which include a pharmacokinetic and pharmacodynamic study and a safety and efficacy study.

Canagliflozin’s most common side effects are vulvovaginal candidiasis and urinary tract infection. Use of the medication can also lead to orthostatic or postural hypotension; that side effect is most common in the first 3 months of therapy, according to the FDA.

The agency said that the drug should not be used in patients with type 1 diabetes, patients on dialysis, or in patients who have diabetic ketoacidosis, severe renal impairment, or end stage renal disease.

Several other SGLT2 inhibitors are in development, including ipragliflozin and empagliflozin. The FDA declined to approve dapagliflozin in 2012 because of safety concerns.

[email protected]

On Twitter @aliciaault

The Food and Drug Administration has approved a new, twice-daily oral medication, dimethyl fumarate, for relapsing-remitting multiple sclerosis.

The drug, to be marketed as Tecfidera, is thought to defend the brain against oxidative stress, and experimental evidence has suggested that it may also act both as an anti-inflammatory and as a neuroprotective agent.

Tecfidera joins a host of already approved medications for MS. Two forms of interferon beta-1a (Avonex and Rebif) and two forms of interferon beta-1b (Betaseron and Extavia) have been approved for the relapsing-remitting form, as has glatiramer acetate (Copaxone), fingolimod (Gilenya), and teriflunomide (Aubagio). Natalizumab (Tysabri) is approved for relapsing-remitting MS, but with restrictions. Mitoxantrone (Novantrone) is approved for secondary progressive, progressive-relapsing, and worsening relapsing-remitting MS, according to the National MS Society. Dalfampridine (Ampyra) is approved to improve walking in individuals with MS.

"No drug provides a cure for multiple sclerosis, so it is important to have a variety of treatment options available for patients," said Dr. Russell Katz, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, in a statement.

According to the FDA, MS is among the most common causes of neurologic disability in young adults and occurs more frequently in women than men. Some 400,000 Americans are living with the condition, and the relapsing-remitting form is the most common. That is characterized by episodes of worsening function, followed by recovery periods. But recovery periods become less complete over time, leading to progressive decline in function and increased disability.

Dimethyl fumarate was approved based on results from two phase III trials that enrolled more than 2,600 patients: DEFINE and CONFIRM. DEFINE data were originally reported at the Fourth Cooperative Meeting on Multiple Sclerosis in 2011 and the CONFIRM data were reported at the Joint Congress of ECTRIMS/ACTRIMS in 2012.

According to Biogen Idec, which makes dimethyl fumarate, relapses were reduced by 49% in patients taking the drug in the DEFINE trial, and disability by 38%. Relapses declined by 34% in the CONFIRM study. In both trials, dimethyl fumarate significantly reduced lesions in the brain, when compared with placebo.

"In clinical trials, patients treated with dimethyl fumarate had less disease activity when compared to patients on placebo – whether they were in the early stages of MS or had more established disease," said Dr. Robert Fox, medical director of the Mellen Center for Multiple Sclerosis at Cleveland Clinic, in a Biogen statement. Dr. Fox was the lead investigator of the CONFIRM study, and is a paid adviser for Biogen Idec for projects not related to dimethyl fumarate. "This drug provides physicians with an important additional treatment option for their patients across the MS spectrum," Dr. Fox said.

The FDA said that dimethyl fumarate decreases lymphocyte counts, but that there was no evidence of an increase in infections in patients taking the drug in trials. The agency recommends monitoring lymphocyte counts before starting therapy, and annually thereafter. Flushing and gastrointestinal problems were the most common adverse reactions.

Biogen said the drug would be available in a matter of days. The recommended starting dose is 120 mg twice a day orally. After a week, the recommended dose increases to 240 mg twice daily.

[email protected]

On Twitter @aliciaault

The Food and Drug Administration has approved a new, twice-daily oral medication, dimethyl fumarate, for relapsing-remitting multiple sclerosis.

The drug, to be marketed as Tecfidera, is thought to defend the brain against oxidative stress, and experimental evidence has suggested that it may also act both as an anti-inflammatory and as a neuroprotective agent.

Tecfidera joins a host of already approved medications for MS. Two forms of interferon beta-1a (Avonex and Rebif) and two forms of interferon beta-1b (Betaseron and Extavia) have been approved for the relapsing-remitting form, as has glatiramer acetate (Copaxone), fingolimod (Gilenya), and teriflunomide (Aubagio). Natalizumab (Tysabri) is approved for relapsing-remitting MS, but with restrictions. Mitoxantrone (Novantrone) is approved for secondary progressive, progressive-relapsing, and worsening relapsing-remitting MS, according to the National MS Society. Dalfampridine (Ampyra) is approved to improve walking in individuals with MS.

"No drug provides a cure for multiple sclerosis, so it is important to have a variety of treatment options available for patients," said Dr. Russell Katz, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, in a statement.

According to the FDA, MS is among the most common causes of neurologic disability in young adults and occurs more frequently in women than men. Some 400,000 Americans are living with the condition, and the relapsing-remitting form is the most common. That is characterized by episodes of worsening function, followed by recovery periods. But recovery periods become less complete over time, leading to progressive decline in function and increased disability.

Dimethyl fumarate was approved based on results from two phase III trials that enrolled more than 2,600 patients: DEFINE and CONFIRM. DEFINE data were originally reported at the Fourth Cooperative Meeting on Multiple Sclerosis in 2011 and the CONFIRM data were reported at the Joint Congress of ECTRIMS/ACTRIMS in 2012.

According to Biogen Idec, which makes dimethyl fumarate, relapses were reduced by 49% in patients taking the drug in the DEFINE trial, and disability by 38%. Relapses declined by 34% in the CONFIRM study. In both trials, dimethyl fumarate significantly reduced lesions in the brain, when compared with placebo.

"In clinical trials, patients treated with dimethyl fumarate had less disease activity when compared to patients on placebo – whether they were in the early stages of MS or had more established disease," said Dr. Robert Fox, medical director of the Mellen Center for Multiple Sclerosis at Cleveland Clinic, in a Biogen statement. Dr. Fox was the lead investigator of the CONFIRM study, and is a paid adviser for Biogen Idec for projects not related to dimethyl fumarate. "This drug provides physicians with an important additional treatment option for their patients across the MS spectrum," Dr. Fox said.

The FDA said that dimethyl fumarate decreases lymphocyte counts, but that there was no evidence of an increase in infections in patients taking the drug in trials. The agency recommends monitoring lymphocyte counts before starting therapy, and annually thereafter. Flushing and gastrointestinal problems were the most common adverse reactions.

Biogen said the drug would be available in a matter of days. The recommended starting dose is 120 mg twice a day orally. After a week, the recommended dose increases to 240 mg twice daily.

[email protected]

On Twitter @aliciaault

The Food and Drug Administration has approved a new, twice-daily oral medication, dimethyl fumarate, for relapsing-remitting multiple sclerosis.

The drug, to be marketed as Tecfidera, is thought to defend the brain against oxidative stress, and experimental evidence has suggested that it may also act both as an anti-inflammatory and as a neuroprotective agent.

Tecfidera joins a host of already approved medications for MS. Two forms of interferon beta-1a (Avonex and Rebif) and two forms of interferon beta-1b (Betaseron and Extavia) have been approved for the relapsing-remitting form, as has glatiramer acetate (Copaxone), fingolimod (Gilenya), and teriflunomide (Aubagio). Natalizumab (Tysabri) is approved for relapsing-remitting MS, but with restrictions. Mitoxantrone (Novantrone) is approved for secondary progressive, progressive-relapsing, and worsening relapsing-remitting MS, according to the National MS Society. Dalfampridine (Ampyra) is approved to improve walking in individuals with MS.

"No drug provides a cure for multiple sclerosis, so it is important to have a variety of treatment options available for patients," said Dr. Russell Katz, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, in a statement.

According to the FDA, MS is among the most common causes of neurologic disability in young adults and occurs more frequently in women than men. Some 400,000 Americans are living with the condition, and the relapsing-remitting form is the most common. That is characterized by episodes of worsening function, followed by recovery periods. But recovery periods become less complete over time, leading to progressive decline in function and increased disability.

Dimethyl fumarate was approved based on results from two phase III trials that enrolled more than 2,600 patients: DEFINE and CONFIRM. DEFINE data were originally reported at the Fourth Cooperative Meeting on Multiple Sclerosis in 2011 and the CONFIRM data were reported at the Joint Congress of ECTRIMS/ACTRIMS in 2012.

According to Biogen Idec, which makes dimethyl fumarate, relapses were reduced by 49% in patients taking the drug in the DEFINE trial, and disability by 38%. Relapses declined by 34% in the CONFIRM study. In both trials, dimethyl fumarate significantly reduced lesions in the brain, when compared with placebo.

"In clinical trials, patients treated with dimethyl fumarate had less disease activity when compared to patients on placebo – whether they were in the early stages of MS or had more established disease," said Dr. Robert Fox, medical director of the Mellen Center for Multiple Sclerosis at Cleveland Clinic, in a Biogen statement. Dr. Fox was the lead investigator of the CONFIRM study, and is a paid adviser for Biogen Idec for projects not related to dimethyl fumarate. "This drug provides physicians with an important additional treatment option for their patients across the MS spectrum," Dr. Fox said.

The FDA said that dimethyl fumarate decreases lymphocyte counts, but that there was no evidence of an increase in infections in patients taking the drug in trials. The agency recommends monitoring lymphocyte counts before starting therapy, and annually thereafter. Flushing and gastrointestinal problems were the most common adverse reactions.

Biogen said the drug would be available in a matter of days. The recommended starting dose is 120 mg twice a day orally. After a week, the recommended dose increases to 240 mg twice daily.

[email protected]

On Twitter @aliciaault

WASHINGTON – Only about 11% of health plan payments to physicians and hospitals are tied to performance or efficiency – meaning that almost 90% of payments are still fee for service, according to a report released March 26 by Catalyst for Payment Reform.

Alicia Ault/IMNG Medical Media

The San Francisco–based nonprofit is a collaborative of employers and health plans that advocates the overhaul of the nation’s health care payment infrastructure by encouraging more value-based payment.

Using data provided by commercial health plans, the group determined that 11% of hospital payments, 6% of outpatient specialist payments, and 6% of primary care physician payments are "value oriented."

Of those payment arrangements, 57% involve provider risk such as bundled payment, capitation, and shared risk payment. The remaining 43% provide incentives, such as shared savings or pay for performance.

The main goal of Catalyst for Payment Reform (CPR) is to raise the volume of value-based commercial payments to health care providers to 20% by 2020. Coalition members said that they saw reason for both pessimism and optimism in the report’s findings.

"Obviously, these results are pretty disappointing," said Dr. Robert Galvin, chief executive officer of Equity Healthcare, which buys health care coverage for private equity companies. Even so, the report itself represents "the triumph of transparency," he said at the press briefing. "It is just simply good to know."

Susan Delbanco, executive director of CPR, noted that in 2010, 1%-3% of provider payments were tied to performance. Given the latest information, "it looks to me like we are on a fast track and that we may get there before 2020,"she said.

The group's research also found that about 2% of health plan enrollees are enrolled in an accountable care organization or a patient-centered medical home.

Most health plan payments (about 75%) are still made to specialists, while 25% go to primary care physicians, according to their analysis. Non–fee-for-service payments are still not entirely rewarding or providing incentives to improve the quality of care. Only 35% of those value-based payments have quality of care as a factor.

Dr. Richard Gilfillan, director of the Center for Medicare and Medicaid Innovation at the Centers for Medicare and Medicaid Services, said that the agency was "thrilled" with the report, noting that it showed that private payers were helping encourage a transformation in payment.

"We’re not discouraged – we think that change is happening, it’s underway," Dr. Gilfillan said at the press briefing.

The growing number of physicians participating in new payment models reflects a cultural shift, said Dr. Mark Smith, president and chief executive officer of the California HealthCare Foundation. "I think we have turned the corner on providers recognizing the feasibility, the desirability, and in fact, the inevitability of the kinds of payment reforms that you’ve heard about."

The California HealthCare Foundation and the Commonwealth Fund provided the funding for the National Scorecard on Payment Reform, and a sister effort, the National Compendium on Payment Reform.

The scorecard tabulated data that 57 health plans provided to the National Business Coalition on Health. Participation is voluntary, and not all 57 plans answered all questions posed. The plans represent 104 million people in the commercial group market, or about two-thirds of the total commercially insured population in the United States. Respondents were primarily large health plans, which means the results may not necessarily reflect the entire group market.

[email protected]

On Twitter @aliciaault

WASHINGTON – Only about 11% of health plan payments to physicians and hospitals are tied to performance or efficiency – meaning that almost 90% of payments are still fee for service, according to a report released March 26 by Catalyst for Payment Reform.

Alicia Ault/IMNG Medical Media

The San Francisco–based nonprofit is a collaborative of employers and health plans that advocates the overhaul of the nation’s health care payment infrastructure by encouraging more value-based payment.

Using data provided by commercial health plans, the group determined that 11% of hospital payments, 6% of outpatient specialist payments, and 6% of primary care physician payments are "value oriented."

Of those payment arrangements, 57% involve provider risk such as bundled payment, capitation, and shared risk payment. The remaining 43% provide incentives, such as shared savings or pay for performance.

The main goal of Catalyst for Payment Reform (CPR) is to raise the volume of value-based commercial payments to health care providers to 20% by 2020. Coalition members said that they saw reason for both pessimism and optimism in the report’s findings.

"Obviously, these results are pretty disappointing," said Dr. Robert Galvin, chief executive officer of Equity Healthcare, which buys health care coverage for private equity companies. Even so, the report itself represents "the triumph of transparency," he said at the press briefing. "It is just simply good to know."

Susan Delbanco, executive director of CPR, noted that in 2010, 1%-3% of provider payments were tied to performance. Given the latest information, "it looks to me like we are on a fast track and that we may get there before 2020,"she said.

The group's research also found that about 2% of health plan enrollees are enrolled in an accountable care organization or a patient-centered medical home.

Most health plan payments (about 75%) are still made to specialists, while 25% go to primary care physicians, according to their analysis. Non–fee-for-service payments are still not entirely rewarding or providing incentives to improve the quality of care. Only 35% of those value-based payments have quality of care as a factor.

Dr. Richard Gilfillan, director of the Center for Medicare and Medicaid Innovation at the Centers for Medicare and Medicaid Services, said that the agency was "thrilled" with the report, noting that it showed that private payers were helping encourage a transformation in payment.

"We’re not discouraged – we think that change is happening, it’s underway," Dr. Gilfillan said at the press briefing.

The growing number of physicians participating in new payment models reflects a cultural shift, said Dr. Mark Smith, president and chief executive officer of the California HealthCare Foundation. "I think we have turned the corner on providers recognizing the feasibility, the desirability, and in fact, the inevitability of the kinds of payment reforms that you’ve heard about."

The California HealthCare Foundation and the Commonwealth Fund provided the funding for the National Scorecard on Payment Reform, and a sister effort, the National Compendium on Payment Reform.

The scorecard tabulated data that 57 health plans provided to the National Business Coalition on Health. Participation is voluntary, and not all 57 plans answered all questions posed. The plans represent 104 million people in the commercial group market, or about two-thirds of the total commercially insured population in the United States. Respondents were primarily large health plans, which means the results may not necessarily reflect the entire group market.

[email protected]

On Twitter @aliciaault

WASHINGTON – Only about 11% of health plan payments to physicians and hospitals are tied to performance or efficiency – meaning that almost 90% of payments are still fee for service, according to a report released March 26 by Catalyst for Payment Reform.

Alicia Ault/IMNG Medical Media

The San Francisco–based nonprofit is a collaborative of employers and health plans that advocates the overhaul of the nation’s health care payment infrastructure by encouraging more value-based payment.

Using data provided by commercial health plans, the group determined that 11% of hospital payments, 6% of outpatient specialist payments, and 6% of primary care physician payments are "value oriented."

Of those payment arrangements, 57% involve provider risk such as bundled payment, capitation, and shared risk payment. The remaining 43% provide incentives, such as shared savings or pay for performance.

The main goal of Catalyst for Payment Reform (CPR) is to raise the volume of value-based commercial payments to health care providers to 20% by 2020. Coalition members said that they saw reason for both pessimism and optimism in the report’s findings.

"Obviously, these results are pretty disappointing," said Dr. Robert Galvin, chief executive officer of Equity Healthcare, which buys health care coverage for private equity companies. Even so, the report itself represents "the triumph of transparency," he said at the press briefing. "It is just simply good to know."

Susan Delbanco, executive director of CPR, noted that in 2010, 1%-3% of provider payments were tied to performance. Given the latest information, "it looks to me like we are on a fast track and that we may get there before 2020,"she said.

The group's research also found that about 2% of health plan enrollees are enrolled in an accountable care organization or a patient-centered medical home.

Most health plan payments (about 75%) are still made to specialists, while 25% go to primary care physicians, according to their analysis. Non–fee-for-service payments are still not entirely rewarding or providing incentives to improve the quality of care. Only 35% of those value-based payments have quality of care as a factor.

Dr. Richard Gilfillan, director of the Center for Medicare and Medicaid Innovation at the Centers for Medicare and Medicaid Services, said that the agency was "thrilled" with the report, noting that it showed that private payers were helping encourage a transformation in payment.

"We’re not discouraged – we think that change is happening, it’s underway," Dr. Gilfillan said at the press briefing.

The growing number of physicians participating in new payment models reflects a cultural shift, said Dr. Mark Smith, president and chief executive officer of the California HealthCare Foundation. "I think we have turned the corner on providers recognizing the feasibility, the desirability, and in fact, the inevitability of the kinds of payment reforms that you’ve heard about."

The California HealthCare Foundation and the Commonwealth Fund provided the funding for the National Scorecard on Payment Reform, and a sister effort, the National Compendium on Payment Reform.

The scorecard tabulated data that 57 health plans provided to the National Business Coalition on Health. Participation is voluntary, and not all 57 plans answered all questions posed. The plans represent 104 million people in the commercial group market, or about two-thirds of the total commercially insured population in the United States. Respondents were primarily large health plans, which means the results may not necessarily reflect the entire group market.

[email protected]

On Twitter @aliciaault

NEW ORLEANS – The continuing onslaught of digital demands is overwhelming many practices’ ability to keep up, driving efficiency down and costs up. The Centers for Medicare and Medicaid Services wants to show that it feels physicians’ pain, and has launched what it calls its "eHealth" initiative to better coordinate and streamline the requests that come out of its offices.

The agency unveiled the initiative at the Healthcare Information and Management Systems Society Annual Conference and exhibition here, with officials telling attendees in multiple sessions – and with an exhibit hall booth and full-page ad in the daily meeting newspaper – how they plan to start paring down demands.

Alicia Ault/IMNG Medical Media

The initiative is the result of at least 18 months of strategizing within the Department of Health and Human Services (HHS) and represents just the beginning of a transformation, Robert Tagalicod, director of the CMS’s Office of E-Health Standards and Services, said in an interview.

HHS officials wanted to curb what they acknowledge is a huge – and growing – regulatory burden for physicians and other health care providers in the information technology area. Much of the focus was on how to better align rules and policies that come out of the CMS with those issued by the Office of the National Coordinator (ONC), which is located within the Office of the Secretary of HHS.

Among other things, the CMS set up a dedicated website for the initiative, www.cms.gov/eHealth, and a listserv that will "act as a central hub of information on implementation, guidance, milestones, and critical steps so that providers and other stakeholders have a single source of information on coordinating efforts toward implementing ICD-10, EHRs and meaningful use, operating standards, electronic quality measurement, and payment models," according to a blog post by Mr. Tagalicod.

The initiative aims to get more physicians using ICD-10, with which they must comply by Oct. 14, 2014. Although the move to that new coding system has been delayed several times, it will not be again, according to CMS Acting Administrator Marilyn Tavenner. "ICD-10 will go forward as designed," Ms. Tavenner told HIMSS13 attendees.

To make it easier for clinicians, the CMS and the ONC are talking about making use of ICD-10 eligible for an incentive payment under stage 3 of the meaningful use program, said Mr. Tagalicod.

In the quality arena, the CMS is going to align measurements with the six core areas set out by the National Quality Strategy. Wherever possible, quality measures will be made similar across CMS programs, said Dr. Kate Goodrich, acting director of the quality measurement and health assessment group at CMS’s Center for Clinical Standards and Quality.

For physicians, that means aligning the measures in the Physician Quality Reporting System with those required for meaningful use, for the Physician Value Modifier (PVM), and for the Medicare Shared Savings Program, said Dr. Goodrich. "The goal is report once – that’s become our mantra," she said. Physicians would report once and get credit for all the programs.

Ms. Tavenner told attendees the agency understands that, over the years, the quality of care programs had become "not easy to understand and even more difficult to implement." Now, the agency has "tried to reduce measures, align measures across programs, and become more focused on outcomes, less on process," she said, adding, "We want your feedback on that."

The eHealth initiative is also working with the National Quality Forum on a task force that aims to come up with a core set of measures that can be used across all payers, not just federal payers.

Part of the eHealth rollout included a "request for information" from health information technology companies on how to accelerate the exchange of data. "Our focus has to be on interoperability this year and we need your help in understanding what is working and where we are going to need to put additional resources," Ms. Tavenner said.

The CMS and other health agencies also are looking ahead to the future, Mr. Tagalicod said – what might happen 10 years down the road in a very quickly developing area. Among the developments the agency is monitoring: mobile health, data exchange in real time, and predictive health.

In the meantime, a big focus will be on "outreach, education, and training to providers" to help them "adopt a whole slew of eHealth," he noted.

"We want to get all the stakeholders together and say: How can we make this all better in a way that we plan it with clear goals, with clear milestones, and with clear roles and responsibilities?" he said.

NEW ORLEANS – The continuing onslaught of digital demands is overwhelming many practices’ ability to keep up, driving efficiency down and costs up. The Centers for Medicare and Medicaid Services wants to show that it feels physicians’ pain, and has launched what it calls its "eHealth" initiative to better coordinate and streamline the requests that come out of its offices.

The agency unveiled the initiative at the Healthcare Information and Management Systems Society Annual Conference and exhibition here, with officials telling attendees in multiple sessions – and with an exhibit hall booth and full-page ad in the daily meeting newspaper – how they plan to start paring down demands.

Alicia Ault/IMNG Medical Media

The initiative is the result of at least 18 months of strategizing within the Department of Health and Human Services (HHS) and represents just the beginning of a transformation, Robert Tagalicod, director of the CMS’s Office of E-Health Standards and Services, said in an interview.

HHS officials wanted to curb what they acknowledge is a huge – and growing – regulatory burden for physicians and other health care providers in the information technology area. Much of the focus was on how to better align rules and policies that come out of the CMS with those issued by the Office of the National Coordinator (ONC), which is located within the Office of the Secretary of HHS.

Among other things, the CMS set up a dedicated website for the initiative, www.cms.gov/eHealth, and a listserv that will "act as a central hub of information on implementation, guidance, milestones, and critical steps so that providers and other stakeholders have a single source of information on coordinating efforts toward implementing ICD-10, EHRs and meaningful use, operating standards, electronic quality measurement, and payment models," according to a blog post by Mr. Tagalicod.

The initiative aims to get more physicians using ICD-10, with which they must comply by Oct. 14, 2014. Although the move to that new coding system has been delayed several times, it will not be again, according to CMS Acting Administrator Marilyn Tavenner. "ICD-10 will go forward as designed," Ms. Tavenner told HIMSS13 attendees.

To make it easier for clinicians, the CMS and the ONC are talking about making use of ICD-10 eligible for an incentive payment under stage 3 of the meaningful use program, said Mr. Tagalicod.

In the quality arena, the CMS is going to align measurements with the six core areas set out by the National Quality Strategy. Wherever possible, quality measures will be made similar across CMS programs, said Dr. Kate Goodrich, acting director of the quality measurement and health assessment group at CMS’s Center for Clinical Standards and Quality.

For physicians, that means aligning the measures in the Physician Quality Reporting System with those required for meaningful use, for the Physician Value Modifier (PVM), and for the Medicare Shared Savings Program, said Dr. Goodrich. "The goal is report once – that’s become our mantra," she said. Physicians would report once and get credit for all the programs.

Ms. Tavenner told attendees the agency understands that, over the years, the quality of care programs had become "not easy to understand and even more difficult to implement." Now, the agency has "tried to reduce measures, align measures across programs, and become more focused on outcomes, less on process," she said, adding, "We want your feedback on that."

The eHealth initiative is also working with the National Quality Forum on a task force that aims to come up with a core set of measures that can be used across all payers, not just federal payers.

Part of the eHealth rollout included a "request for information" from health information technology companies on how to accelerate the exchange of data. "Our focus has to be on interoperability this year and we need your help in understanding what is working and where we are going to need to put additional resources," Ms. Tavenner said.

The CMS and other health agencies also are looking ahead to the future, Mr. Tagalicod said – what might happen 10 years down the road in a very quickly developing area. Among the developments the agency is monitoring: mobile health, data exchange in real time, and predictive health.

In the meantime, a big focus will be on "outreach, education, and training to providers" to help them "adopt a whole slew of eHealth," he noted.

"We want to get all the stakeholders together and say: How can we make this all better in a way that we plan it with clear goals, with clear milestones, and with clear roles and responsibilities?" he said.

NEW ORLEANS – The continuing onslaught of digital demands is overwhelming many practices’ ability to keep up, driving efficiency down and costs up. The Centers for Medicare and Medicaid Services wants to show that it feels physicians’ pain, and has launched what it calls its "eHealth" initiative to better coordinate and streamline the requests that come out of its offices.

The agency unveiled the initiative at the Healthcare Information and Management Systems Society Annual Conference and exhibition here, with officials telling attendees in multiple sessions – and with an exhibit hall booth and full-page ad in the daily meeting newspaper – how they plan to start paring down demands.

Alicia Ault/IMNG Medical Media

The initiative is the result of at least 18 months of strategizing within the Department of Health and Human Services (HHS) and represents just the beginning of a transformation, Robert Tagalicod, director of the CMS’s Office of E-Health Standards and Services, said in an interview.

HHS officials wanted to curb what they acknowledge is a huge – and growing – regulatory burden for physicians and other health care providers in the information technology area. Much of the focus was on how to better align rules and policies that come out of the CMS with those issued by the Office of the National Coordinator (ONC), which is located within the Office of the Secretary of HHS.

Among other things, the CMS set up a dedicated website for the initiative, www.cms.gov/eHealth, and a listserv that will "act as a central hub of information on implementation, guidance, milestones, and critical steps so that providers and other stakeholders have a single source of information on coordinating efforts toward implementing ICD-10, EHRs and meaningful use, operating standards, electronic quality measurement, and payment models," according to a blog post by Mr. Tagalicod.

The initiative aims to get more physicians using ICD-10, with which they must comply by Oct. 14, 2014. Although the move to that new coding system has been delayed several times, it will not be again, according to CMS Acting Administrator Marilyn Tavenner. "ICD-10 will go forward as designed," Ms. Tavenner told HIMSS13 attendees.

To make it easier for clinicians, the CMS and the ONC are talking about making use of ICD-10 eligible for an incentive payment under stage 3 of the meaningful use program, said Mr. Tagalicod.

In the quality arena, the CMS is going to align measurements with the six core areas set out by the National Quality Strategy. Wherever possible, quality measures will be made similar across CMS programs, said Dr. Kate Goodrich, acting director of the quality measurement and health assessment group at CMS’s Center for Clinical Standards and Quality.

For physicians, that means aligning the measures in the Physician Quality Reporting System with those required for meaningful use, for the Physician Value Modifier (PVM), and for the Medicare Shared Savings Program, said Dr. Goodrich. "The goal is report once – that’s become our mantra," she said. Physicians would report once and get credit for all the programs.

Ms. Tavenner told attendees the agency understands that, over the years, the quality of care programs had become "not easy to understand and even more difficult to implement." Now, the agency has "tried to reduce measures, align measures across programs, and become more focused on outcomes, less on process," she said, adding, "We want your feedback on that."

The eHealth initiative is also working with the National Quality Forum on a task force that aims to come up with a core set of measures that can be used across all payers, not just federal payers.

Part of the eHealth rollout included a "request for information" from health information technology companies on how to accelerate the exchange of data. "Our focus has to be on interoperability this year and we need your help in understanding what is working and where we are going to need to put additional resources," Ms. Tavenner said.

The CMS and other health agencies also are looking ahead to the future, Mr. Tagalicod said – what might happen 10 years down the road in a very quickly developing area. Among the developments the agency is monitoring: mobile health, data exchange in real time, and predictive health.

In the meantime, a big focus will be on "outreach, education, and training to providers" to help them "adopt a whole slew of eHealth," he noted.

"We want to get all the stakeholders together and say: How can we make this all better in a way that we plan it with clear goals, with clear milestones, and with clear roles and responsibilities?" he said.

NEW ORLEANS – The Centers for Medicare and Medicaid Services is expecting half of eligible physician offices and 80% of eligible hospitals to be meaningful users of electronic health records this year – a target that even the agency itself calls aggressive.

To date, 161,890 eligible professionals – out of 527,200 who are eligible – have attested to meaningful use, according to the most recent statistics from CMS. Most of those (161,677) did so successfully. About 200 were not successful. Of the 5,011 hospitals that are eligible, 2,653 have been successful. None failed.

So far, all of the eligible professionals and hospitals have had to prove only that they are meaningful users under stage 1 of the program. The rules outlining stage 2 criteria were published last year. The earliest physicians would have to attest to stage 2 criteria would be in 2014.

Even so, "2013 is going to be a busy year," said CMS Acting Administrator Marilyn Tavenner at the Healthcare Information and Management Systems Society annual conference. But the agency will try to take some heat off physicians and hospitals struggling to work within stage 1 and ramping up for stage 2, she said.

"We are going to spend 2013 focusing on education, focusing on learning, and focusing on what is working in stage 2 and what is not working in stage 2," said Ms. Tavenner.

She added that doctors would get a special focus this year. "We’re going to spend a lot more time with physicians – helping physicians learn, and helping physicians work with their current vendors to make things a little easier for them," Ms. Tavenner promised.

Under stage 2, physicians will have to meet a total of 20 core objectives. Among the new objectives: demonstrating the ability to use secure electronic messaging to communicate with patients; and providing patients the ability to view online, download, and transmit their health information within 4 days of those data being available to the doctor.

CMS still aims to have physicians begin attesting to stage 3 in 2016. However, the agency will hold off on issuing any stage 3 regulations for now, she said. "We are not going to issue additional rules in 2013," Ms. Tavenner said. "We are going to learn from stage 2 so it can help us design where we are going in stage 3."

Part of that learning curve will include what Ms. Tavenner called "tiny" audits. The idea is that CMS would work collaboratively with physicians and hospitals to figure out how to begin to audit electronic health records.

"This is a give and take – this is not like a payment audit," she explained. The goal is to understand what happens once a system is installed – that is, are physicians using it regularly and getting any benefit – and to determine what changes CMS might need to make, said Ms. Tavenner.

The agency will also convene a summit with physicians, hospitals, systems vendors, and government officials in May, she said. Again, the focus will be on understanding what needs to happen in stage 2.

[email protected]

On Twitter @aliciaault

NEW ORLEANS – The Centers for Medicare and Medicaid Services is expecting half of eligible physician offices and 80% of eligible hospitals to be meaningful users of electronic health records this year – a target that even the agency itself calls aggressive.

To date, 161,890 eligible professionals – out of 527,200 who are eligible – have attested to meaningful use, according to the most recent statistics from CMS. Most of those (161,677) did so successfully. About 200 were not successful. Of the 5,011 hospitals that are eligible, 2,653 have been successful. None failed.

So far, all of the eligible professionals and hospitals have had to prove only that they are meaningful users under stage 1 of the program. The rules outlining stage 2 criteria were published last year. The earliest physicians would have to attest to stage 2 criteria would be in 2014.

Even so, "2013 is going to be a busy year," said CMS Acting Administrator Marilyn Tavenner at the Healthcare Information and Management Systems Society annual conference. But the agency will try to take some heat off physicians and hospitals struggling to work within stage 1 and ramping up for stage 2, she said.

"We are going to spend 2013 focusing on education, focusing on learning, and focusing on what is working in stage 2 and what is not working in stage 2," said Ms. Tavenner.

She added that doctors would get a special focus this year. "We’re going to spend a lot more time with physicians – helping physicians learn, and helping physicians work with their current vendors to make things a little easier for them," Ms. Tavenner promised.

Under stage 2, physicians will have to meet a total of 20 core objectives. Among the new objectives: demonstrating the ability to use secure electronic messaging to communicate with patients; and providing patients the ability to view online, download, and transmit their health information within 4 days of those data being available to the doctor.

CMS still aims to have physicians begin attesting to stage 3 in 2016. However, the agency will hold off on issuing any stage 3 regulations for now, she said. "We are not going to issue additional rules in 2013," Ms. Tavenner said. "We are going to learn from stage 2 so it can help us design where we are going in stage 3."

Part of that learning curve will include what Ms. Tavenner called "tiny" audits. The idea is that CMS would work collaboratively with physicians and hospitals to figure out how to begin to audit electronic health records.

"This is a give and take – this is not like a payment audit," she explained. The goal is to understand what happens once a system is installed – that is, are physicians using it regularly and getting any benefit – and to determine what changes CMS might need to make, said Ms. Tavenner.

The agency will also convene a summit with physicians, hospitals, systems vendors, and government officials in May, she said. Again, the focus will be on understanding what needs to happen in stage 2.

[email protected]

On Twitter @aliciaault

NEW ORLEANS – The Centers for Medicare and Medicaid Services is expecting half of eligible physician offices and 80% of eligible hospitals to be meaningful users of electronic health records this year – a target that even the agency itself calls aggressive.

To date, 161,890 eligible professionals – out of 527,200 who are eligible – have attested to meaningful use, according to the most recent statistics from CMS. Most of those (161,677) did so successfully. About 200 were not successful. Of the 5,011 hospitals that are eligible, 2,653 have been successful. None failed.

So far, all of the eligible professionals and hospitals have had to prove only that they are meaningful users under stage 1 of the program. The rules outlining stage 2 criteria were published last year. The earliest physicians would have to attest to stage 2 criteria would be in 2014.

Even so, "2013 is going to be a busy year," said CMS Acting Administrator Marilyn Tavenner at the Healthcare Information and Management Systems Society annual conference. But the agency will try to take some heat off physicians and hospitals struggling to work within stage 1 and ramping up for stage 2, she said.

"We are going to spend 2013 focusing on education, focusing on learning, and focusing on what is working in stage 2 and what is not working in stage 2," said Ms. Tavenner.

She added that doctors would get a special focus this year. "We’re going to spend a lot more time with physicians – helping physicians learn, and helping physicians work with their current vendors to make things a little easier for them," Ms. Tavenner promised.

Under stage 2, physicians will have to meet a total of 20 core objectives. Among the new objectives: demonstrating the ability to use secure electronic messaging to communicate with patients; and providing patients the ability to view online, download, and transmit their health information within 4 days of those data being available to the doctor.

CMS still aims to have physicians begin attesting to stage 3 in 2016. However, the agency will hold off on issuing any stage 3 regulations for now, she said. "We are not going to issue additional rules in 2013," Ms. Tavenner said. "We are going to learn from stage 2 so it can help us design where we are going in stage 3."

Part of that learning curve will include what Ms. Tavenner called "tiny" audits. The idea is that CMS would work collaboratively with physicians and hospitals to figure out how to begin to audit electronic health records.

"This is a give and take – this is not like a payment audit," she explained. The goal is to understand what happens once a system is installed – that is, are physicians using it regularly and getting any benefit – and to determine what changes CMS might need to make, said Ms. Tavenner.

The agency will also convene a summit with physicians, hospitals, systems vendors, and government officials in May, she said. Again, the focus will be on understanding what needs to happen in stage 2.

[email protected]

On Twitter @aliciaault

NEW ORLEANS – Frustrated with your electronic medical record system? Getting increasingly irritated? You most definitely are not alone.

A survey of thousands of physicians across multiple specialties shows that user satisfaction with electronic health records fell 12% from 2010 to 2012.

The survey was conducted by the American College of Physicians and AmericanEHR Partners, an online agent that helps physicians select and evaluate health information technology. It is supported by 16 medical societies and five health IT organizations.

"Dissatisfaction is increasing regardless of practice type or EHR system," said Dr. Michael S. Barr, who leads ACP\'s Medical Practice, Professionalism & Quality division. "These findings highlight the need for the Meaningful Use program and EHR manufacturers to focus on improving EHR features and usability to help reduce inefficient work flows, improve error rates and patient care, and for practices to recognize the importance of ongoing training at all stages of EHR adoption," said Dr. Barr, in a statement issued along with the survey results.

The survey was released at the Healthcare Information and Management Systems Society Annual Conference and exhibition.

Dr. Alan Brookstone, a cofounder of AmericanEHR Partners, said at the meeting that satisfaction rates may be dropping in part because there had been so much adoption of technology so quickly. Also, it’s not just the early adopters anymore, he said.

The largest number of respondents – almost 1,900 – was from primary care. Specialists, surgeons, hospital-based physicians, and psychiatrists were also represented.

The vast majority of respondents – 70% – were from practices with fewer than 10 physicians.

The number who said they intended to participate in meaningful use has grown over the past few years, with a full 82% saying they would apply for incentives paid by Medicare and Medicaid.

Satisfaction rates with current EHR systems were low across a spectrum of parameters. While 45% said they would recommend the product they use to a colleague, 39% said they would not. In 2010, more physicians said they’d recommend that system, while only 24% said they would urge against use.

Of those surveyed, 36% said that they had encountered unexpected events, problems, or costs after signing the initial contract for the system.

Physicians were especially frustrated with the systems’ promise to decrease their workload. Thirty-four percent said they were dissatisfied with that promised ability, up from only 19% in 2010. Some respondents said that the EHR had decreased productivity and increased the amount of time needed to complete documentation. Fully a third of respondents said they had not returned to the productivity they had before they began to use the system.

About half of respondents were satisfied with functionality and ease of use, but a third were dissatisfied with those measures. That level of dissatisfaction was higher than it had been in 2010.

For instance, thirty-six percent said that it was difficult to reconcile an imported medication list with medications listed in a patient record.

Overall, when compared with other specialties, primary care physicians were the most satisfied with their system’s ability to improve patient care. Surgeons, representing about 660 respondents, were the least satisfied.

Good customer support and training for the EHR systems was rated as crucial to satisfaction. There was an 11% increase in dissatisfaction with customer support from 2010 to 2012. Thirty-three percent of respondents said they weren’t happy with the customer support they received.

The number of practices using a patient portal increased by 20% from 2010 to 2012, rising to 40%. This is probably driven by the stage 2 meaningful use rules, which require physicians to be able to securely communicate with patients and for patients to be able to download and share their health information. Still, 50% of respondents did not have a portal.

Dr. Brookstone said they survey showed that vendors needed to better integrate functionality, improve training, and find ways to help physicians rebalance their workload.

If physicians’ concerns aren’t addressed, it will lead to a decline in willingness to use the systems, he said.

NEW ORLEANS – Frustrated with your electronic medical record system? Getting increasingly irritated? You most definitely are not alone.

A survey of thousands of physicians across multiple specialties shows that user satisfaction with electronic health records fell 12% from 2010 to 2012.

The survey was conducted by the American College of Physicians and AmericanEHR Partners, an online agent that helps physicians select and evaluate health information technology. It is supported by 16 medical societies and five health IT organizations.

"Dissatisfaction is increasing regardless of practice type or EHR system," said Dr. Michael S. Barr, who leads ACP\'s Medical Practice, Professionalism & Quality division. "These findings highlight the need for the Meaningful Use program and EHR manufacturers to focus on improving EHR features and usability to help reduce inefficient work flows, improve error rates and patient care, and for practices to recognize the importance of ongoing training at all stages of EHR adoption," said Dr. Barr, in a statement issued along with the survey results.

The survey was released at the Healthcare Information and Management Systems Society Annual Conference and exhibition.

Dr. Alan Brookstone, a cofounder of AmericanEHR Partners, said at the meeting that satisfaction rates may be dropping in part because there had been so much adoption of technology so quickly. Also, it’s not just the early adopters anymore, he said.

The largest number of respondents – almost 1,900 – was from primary care. Specialists, surgeons, hospital-based physicians, and psychiatrists were also represented.

The vast majority of respondents – 70% – were from practices with fewer than 10 physicians.

The number who said they intended to participate in meaningful use has grown over the past few years, with a full 82% saying they would apply for incentives paid by Medicare and Medicaid.

Satisfaction rates with current EHR systems were low across a spectrum of parameters. While 45% said they would recommend the product they use to a colleague, 39% said they would not. In 2010, more physicians said they’d recommend that system, while only 24% said they would urge against use.

Of those surveyed, 36% said that they had encountered unexpected events, problems, or costs after signing the initial contract for the system.

Physicians were especially frustrated with the systems’ promise to decrease their workload. Thirty-four percent said they were dissatisfied with that promised ability, up from only 19% in 2010. Some respondents said that the EHR had decreased productivity and increased the amount of time needed to complete documentation. Fully a third of respondents said they had not returned to the productivity they had before they began to use the system.

About half of respondents were satisfied with functionality and ease of use, but a third were dissatisfied with those measures. That level of dissatisfaction was higher than it had been in 2010.

For instance, thirty-six percent said that it was difficult to reconcile an imported medication list with medications listed in a patient record.

Overall, when compared with other specialties, primary care physicians were the most satisfied with their system’s ability to improve patient care. Surgeons, representing about 660 respondents, were the least satisfied.

Good customer support and training for the EHR systems was rated as crucial to satisfaction. There was an 11% increase in dissatisfaction with customer support from 2010 to 2012. Thirty-three percent of respondents said they weren’t happy with the customer support they received.

The number of practices using a patient portal increased by 20% from 2010 to 2012, rising to 40%. This is probably driven by the stage 2 meaningful use rules, which require physicians to be able to securely communicate with patients and for patients to be able to download and share their health information. Still, 50% of respondents did not have a portal.

Dr. Brookstone said they survey showed that vendors needed to better integrate functionality, improve training, and find ways to help physicians rebalance their workload.

If physicians’ concerns aren’t addressed, it will lead to a decline in willingness to use the systems, he said.

NEW ORLEANS – Frustrated with your electronic medical record system? Getting increasingly irritated? You most definitely are not alone.

A survey of thousands of physicians across multiple specialties shows that user satisfaction with electronic health records fell 12% from 2010 to 2012.

The survey was conducted by the American College of Physicians and AmericanEHR Partners, an online agent that helps physicians select and evaluate health information technology. It is supported by 16 medical societies and five health IT organizations.

"Dissatisfaction is increasing regardless of practice type or EHR system," said Dr. Michael S. Barr, who leads ACP\'s Medical Practice, Professionalism & Quality division. "These findings highlight the need for the Meaningful Use program and EHR manufacturers to focus on improving EHR features and usability to help reduce inefficient work flows, improve error rates and patient care, and for practices to recognize the importance of ongoing training at all stages of EHR adoption," said Dr. Barr, in a statement issued along with the survey results.

The survey was released at the Healthcare Information and Management Systems Society Annual Conference and exhibition.

Dr. Alan Brookstone, a cofounder of AmericanEHR Partners, said at the meeting that satisfaction rates may be dropping in part because there had been so much adoption of technology so quickly. Also, it’s not just the early adopters anymore, he said.

The largest number of respondents – almost 1,900 – was from primary care. Specialists, surgeons, hospital-based physicians, and psychiatrists were also represented.

The vast majority of respondents – 70% – were from practices with fewer than 10 physicians.

The number who said they intended to participate in meaningful use has grown over the past few years, with a full 82% saying they would apply for incentives paid by Medicare and Medicaid.

Satisfaction rates with current EHR systems were low across a spectrum of parameters. While 45% said they would recommend the product they use to a colleague, 39% said they would not. In 2010, more physicians said they’d recommend that system, while only 24% said they would urge against use.

Of those surveyed, 36% said that they had encountered unexpected events, problems, or costs after signing the initial contract for the system.

Physicians were especially frustrated with the systems’ promise to decrease their workload. Thirty-four percent said they were dissatisfied with that promised ability, up from only 19% in 2010. Some respondents said that the EHR had decreased productivity and increased the amount of time needed to complete documentation. Fully a third of respondents said they had not returned to the productivity they had before they began to use the system.

About half of respondents were satisfied with functionality and ease of use, but a third were dissatisfied with those measures. That level of dissatisfaction was higher than it had been in 2010.

For instance, thirty-six percent said that it was difficult to reconcile an imported medication list with medications listed in a patient record.

Overall, when compared with other specialties, primary care physicians were the most satisfied with their system’s ability to improve patient care. Surgeons, representing about 660 respondents, were the least satisfied.

Good customer support and training for the EHR systems was rated as crucial to satisfaction. There was an 11% increase in dissatisfaction with customer support from 2010 to 2012. Thirty-three percent of respondents said they weren’t happy with the customer support they received.

The number of practices using a patient portal increased by 20% from 2010 to 2012, rising to 40%. This is probably driven by the stage 2 meaningful use rules, which require physicians to be able to securely communicate with patients and for patients to be able to download and share their health information. Still, 50% of respondents did not have a portal.

Dr. Brookstone said they survey showed that vendors needed to better integrate functionality, improve training, and find ways to help physicians rebalance their workload.

If physicians’ concerns aren’t addressed, it will lead to a decline in willingness to use the systems, he said.

NEW ORLEANS – Haven’t received your meaningful use incentive? Check your mail for an audit letter.

If in January you submitted an attestation of meaningful use of your electronic health record – with an eye to reaping the federal health IT incentive – an audit letter may be on its way to you.

A contractor for the Centers for Medicare and Medicaid Services began sending audit letters this week to randomly selected Medicare-eligible professionals and hospitals, Elizabeth Holland, a director of the HIT Initiatives Group in the agency’s Office of E-Health Standards and Services, said March 5 at the Healthcare Information and Management Systems Society annual conference. The audits could result in delays or ultimately, non-payment, she said.

©Brian Jackson/iStockphoto.com

"We have a fiduciary responsibility to make sure that we are paying appropriately," Ms. Holland explained, adding that providers who were not selected for the audit have already received their payments.

Audit letters are being sent by Figliozzi & Co. to Medicare-eligible hospitals and physicians. If recipients do not respond, "their payment will be held up until they respond and provide the documentation" to back up their attestation, Ms. Holland said. "If a certain amount of time goes by and they still don’t respond, they will not be getting a payment."

These prepayment audits follow on the heels of postpayment audits that the CMS began in July 2012. Under that program, Figliozzi & Co. audited Medicare-eligible professionals and states audited Medicaid-eligible professionals.

Ms. Holland said that more than 2,000 postpayment audits are underway; some are random and some are targeted. The data generated by the audits is, and will be, used to modify the agency’s approach to meaningful use. For instance, one goal is to see whether providers are appropriately reporting measures, she said.

CMS also has found that professionals do not have the proper documentation to support what they are attesting to. In the next month, the CMS will issue guidance on what documentation is needed, Ms. Holland said.

She presented data showing that so far, 161,890 eligible professionals – out of 527,200 who are eligible – have attested to meaningful use. Most of those (161,677) did so successfully. About 200 were not successful.

Of the 5,011 hospitals that are eligible, 2,653 have been successful. None failed.

[email protected]

On Twitter @aliciaault

NEW ORLEANS – Haven’t received your meaningful use incentive? Check your mail for an audit letter.

If in January you submitted an attestation of meaningful use of your electronic health record – with an eye to reaping the federal health IT incentive – an audit letter may be on its way to you.

A contractor for the Centers for Medicare and Medicaid Services began sending audit letters this week to randomly selected Medicare-eligible professionals and hospitals, Elizabeth Holland, a director of the HIT Initiatives Group in the agency’s Office of E-Health Standards and Services, said March 5 at the Healthcare Information and Management Systems Society annual conference. The audits could result in delays or ultimately, non-payment, she said.

©Brian Jackson/iStockphoto.com

"We have a fiduciary responsibility to make sure that we are paying appropriately," Ms. Holland explained, adding that providers who were not selected for the audit have already received their payments.

Audit letters are being sent by Figliozzi & Co. to Medicare-eligible hospitals and physicians. If recipients do not respond, "their payment will be held up until they respond and provide the documentation" to back up their attestation, Ms. Holland said. "If a certain amount of time goes by and they still don’t respond, they will not be getting a payment."

These prepayment audits follow on the heels of postpayment audits that the CMS began in July 2012. Under that program, Figliozzi & Co. audited Medicare-eligible professionals and states audited Medicaid-eligible professionals.

Ms. Holland said that more than 2,000 postpayment audits are underway; some are random and some are targeted. The data generated by the audits is, and will be, used to modify the agency’s approach to meaningful use. For instance, one goal is to see whether providers are appropriately reporting measures, she said.

CMS also has found that professionals do not have the proper documentation to support what they are attesting to. In the next month, the CMS will issue guidance on what documentation is needed, Ms. Holland said.

She presented data showing that so far, 161,890 eligible professionals – out of 527,200 who are eligible – have attested to meaningful use. Most of those (161,677) did so successfully. About 200 were not successful.

Of the 5,011 hospitals that are eligible, 2,653 have been successful. None failed.

[email protected]

On Twitter @aliciaault

NEW ORLEANS – Haven’t received your meaningful use incentive? Check your mail for an audit letter.

If in January you submitted an attestation of meaningful use of your electronic health record – with an eye to reaping the federal health IT incentive – an audit letter may be on its way to you.

A contractor for the Centers for Medicare and Medicaid Services began sending audit letters this week to randomly selected Medicare-eligible professionals and hospitals, Elizabeth Holland, a director of the HIT Initiatives Group in the agency’s Office of E-Health Standards and Services, said March 5 at the Healthcare Information and Management Systems Society annual conference. The audits could result in delays or ultimately, non-payment, she said.

©Brian Jackson/iStockphoto.com

"We have a fiduciary responsibility to make sure that we are paying appropriately," Ms. Holland explained, adding that providers who were not selected for the audit have already received their payments.

Audit letters are being sent by Figliozzi & Co. to Medicare-eligible hospitals and physicians. If recipients do not respond, "their payment will be held up until they respond and provide the documentation" to back up their attestation, Ms. Holland said. "If a certain amount of time goes by and they still don’t respond, they will not be getting a payment."

These prepayment audits follow on the heels of postpayment audits that the CMS began in July 2012. Under that program, Figliozzi & Co. audited Medicare-eligible professionals and states audited Medicaid-eligible professionals.

Ms. Holland said that more than 2,000 postpayment audits are underway; some are random and some are targeted. The data generated by the audits is, and will be, used to modify the agency’s approach to meaningful use. For instance, one goal is to see whether providers are appropriately reporting measures, she said.

CMS also has found that professionals do not have the proper documentation to support what they are attesting to. In the next month, the CMS will issue guidance on what documentation is needed, Ms. Holland said.

She presented data showing that so far, 161,890 eligible professionals – out of 527,200 who are eligible – have attested to meaningful use. Most of those (161,677) did so successfully. About 200 were not successful.

Of the 5,011 hospitals that are eligible, 2,653 have been successful. None failed.

[email protected]

On Twitter @aliciaault

The Department of Health and Human Services has issued its final rule on what kinds of coverage must be offered by almost all health plans starting in 2014.

The rule outlines the parameters for the so-called essential health benefits that must be included in health plans offered through the health exchanges, and in the individual and small group markets, and also sets out guidelines for an expansion of mental health and substance use disorders.

As outlined in previous proposals and bulletins from the Administration, the rule requires plans to cover services in 10 categories: ambulatory patient services; emergency services; hospitalization; maternity and newborn care; mental health and substance use disorder services, including behavioral health treatment; prescription drugs; rehabilitative and habilitative services and devices; laboratory services; preventive and wellness services and chronic disease management; and pediatric services, including oral and vision care.

The final rule also spells out that health insurers must cover mental health and substance abuse services starting in 2014.

At that time, some 3.9 million Americans who currently have individual policies, and 1.2 million who are in small group plans will be covered for those benefits for the first time, according to the HHS.

The essential health benefit rule also broadens the parity requirement for mental health coverage, first established under the Mental Health Parity and Addiction Equity Act of 2008.

Health plans covered by the rule will also be categorized according to the value of the benefits they provide. The lowest-value plan will be bronze, in which patients will be responsible for about 40% of the costs of covered benefits. For the silver plans, policyholders will pay 30% of the costs; for a gold plan, 20%, and for a platinum plan, 10%.

As expected, the rule gives states a fair amount of flexibility in meeting the requirements for essential health benefits. But they must select a "benchmark" plan and offer benefits that are equivalent – either by matching benefits or providing the actuarial equivalent – to that benchmark.

The benchmark plan is required to include the services and benefits in the 10 categories. If the benchmark plan is missing any of those services, the final rule gives guidance on how the state or health plan can add the benefits.

Benchmark plans selected now will be used for coverage in 2014 and 2015.

Under the Affordable Care Act, the rule applies to all "non-grandfathered" health insurance plans offered through state health insurance exchanges, and also policies in the individual and small group market that are sold outside the exchanges.

Grandfathered plans are primarily those that were already in place when the ACA was signed into law on March 23, 2010.

HHS said that it received almost 6,000 comments on the various proposals it floated on the essential health benefits package since December 2011.

The final rule issued on Feb. 20 goes into effect on March 20.

[email protected]

On Twitter @aliciaault

The Department of Health and Human Services has issued its final rule on what kinds of coverage must be offered by almost all health plans starting in 2014.

The rule outlines the parameters for the so-called essential health benefits that must be included in health plans offered through the health exchanges, and in the individual and small group markets, and also sets out guidelines for an expansion of mental health and substance use disorders.

As outlined in previous proposals and bulletins from the Administration, the rule requires plans to cover services in 10 categories: ambulatory patient services; emergency services; hospitalization; maternity and newborn care; mental health and substance use disorder services, including behavioral health treatment; prescription drugs; rehabilitative and habilitative services and devices; laboratory services; preventive and wellness services and chronic disease management; and pediatric services, including oral and vision care.

The final rule also spells out that health insurers must cover mental health and substance abuse services starting in 2014.

At that time, some 3.9 million Americans who currently have individual policies, and 1.2 million who are in small group plans will be covered for those benefits for the first time, according to the HHS.

The essential health benefit rule also broadens the parity requirement for mental health coverage, first established under the Mental Health Parity and Addiction Equity Act of 2008.

Health plans covered by the rule will also be categorized according to the value of the benefits they provide. The lowest-value plan will be bronze, in which patients will be responsible for about 40% of the costs of covered benefits. For the silver plans, policyholders will pay 30% of the costs; for a gold plan, 20%, and for a platinum plan, 10%.

As expected, the rule gives states a fair amount of flexibility in meeting the requirements for essential health benefits. But they must select a "benchmark" plan and offer benefits that are equivalent – either by matching benefits or providing the actuarial equivalent – to that benchmark.

The benchmark plan is required to include the services and benefits in the 10 categories. If the benchmark plan is missing any of those services, the final rule gives guidance on how the state or health plan can add the benefits.

Benchmark plans selected now will be used for coverage in 2014 and 2015.

Under the Affordable Care Act, the rule applies to all "non-grandfathered" health insurance plans offered through state health insurance exchanges, and also policies in the individual and small group market that are sold outside the exchanges.

Grandfathered plans are primarily those that were already in place when the ACA was signed into law on March 23, 2010.

HHS said that it received almost 6,000 comments on the various proposals it floated on the essential health benefits package since December 2011.

The final rule issued on Feb. 20 goes into effect on March 20.

[email protected]

On Twitter @aliciaault

The Department of Health and Human Services has issued its final rule on what kinds of coverage must be offered by almost all health plans starting in 2014.

The rule outlines the parameters for the so-called essential health benefits that must be included in health plans offered through the health exchanges, and in the individual and small group markets, and also sets out guidelines for an expansion of mental health and substance use disorders.

As outlined in previous proposals and bulletins from the Administration, the rule requires plans to cover services in 10 categories: ambulatory patient services; emergency services; hospitalization; maternity and newborn care; mental health and substance use disorder services, including behavioral health treatment; prescription drugs; rehabilitative and habilitative services and devices; laboratory services; preventive and wellness services and chronic disease management; and pediatric services, including oral and vision care.

The final rule also spells out that health insurers must cover mental health and substance abuse services starting in 2014.

At that time, some 3.9 million Americans who currently have individual policies, and 1.2 million who are in small group plans will be covered for those benefits for the first time, according to the HHS.

The essential health benefit rule also broadens the parity requirement for mental health coverage, first established under the Mental Health Parity and Addiction Equity Act of 2008.

Health plans covered by the rule will also be categorized according to the value of the benefits they provide. The lowest-value plan will be bronze, in which patients will be responsible for about 40% of the costs of covered benefits. For the silver plans, policyholders will pay 30% of the costs; for a gold plan, 20%, and for a platinum plan, 10%.

As expected, the rule gives states a fair amount of flexibility in meeting the requirements for essential health benefits. But they must select a "benchmark" plan and offer benefits that are equivalent – either by matching benefits or providing the actuarial equivalent – to that benchmark.

The benchmark plan is required to include the services and benefits in the 10 categories. If the benchmark plan is missing any of those services, the final rule gives guidance on how the state or health plan can add the benefits.

Benchmark plans selected now will be used for coverage in 2014 and 2015.

Under the Affordable Care Act, the rule applies to all "non-grandfathered" health insurance plans offered through state health insurance exchanges, and also policies in the individual and small group market that are sold outside the exchanges.

Grandfathered plans are primarily those that were already in place when the ACA was signed into law on March 23, 2010.

HHS said that it received almost 6,000 comments on the various proposals it floated on the essential health benefits package since December 2011.

The final rule issued on Feb. 20 goes into effect on March 20.

[email protected]

On Twitter @aliciaault