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ABIM responds to criticism, makes major changes to MOC
In a frank announcement, the American Board of Internal Medicine has apologized to doctors for a Maintenance of Certification program that “clearly got it wrong,” and pledged to make the program more consistent with internists’ practice and values.
Among the immediate changes: updates to its internal medicine exam; suspension of the practice assessment, patient voice, and patient safety requirements for at least 2 years; and MOC enrollment fees set at or below the 2014 levels through at least 2017.
Dr. David A. Fleming, president of the American College of Physicians (ACP), called the move monumental and historic.
“This turnaround has occurred in the face of mounting pressure and discontent expressed by a growing number of U.S. internists concerned about the MOC process,” Dr. Fleming said in an interview. “With the new changes in MOC, internists are still being held accountable and responsible for maintaining professional competence, but by removing the practice assessment and patient [safety] requirements that are not well supported by evidence, we go a long way in taking the pressure off very busy physicians who already feel burdened by many layers of regulatory and administrative reporting that many view as burdensome and a barrier to our first duty – caring for patients.”
In a statement, ABIM President and CEO Dr. Richard J. Baron said it was clear that aspects of the program were not meeting physicians’ needs.
“We got it wrong and sincerely apologize,” Dr. Baron said in the statement. “We are sorry. ABIM is changing the way it does its work so that it is guided by, and integrated fully with, the medical community that created it. The goal is to co-create an MOC program that reflects the medical community’s shared values about the practice of medicine today and provides a professionally created and publicly recognizable framework for keeping up in our discipline.”
As part of the newly announced changes, ABIM will make its internal medicine exam more reflective of physician practice, with changes to be incorporated in fall 2015, according to the announcement. The decision to suspend the practice assessment, patient voice, and patient safety requirements means internists who have not completed activities in these areas will not have their certification status changed. Diplomates who are currently uncertified but who have satisfied all requirements for MOC except for the practice assessment requirement will be issued a new certificate this year. Within the next 6 months, ABIM will also change the language used to publicly report a diplomate’s MOC status on its website from “meeting MOC requirements” to “participating in MOC.”
By the end of 2015, ABIM said it will assure new and more flexible ways for internists to demonstrate self-assessment of medical knowledge by recognizing most forms of Accreditation Council for Continuing Medical Education–approved continuing medical education. An online FAQ provides more information on the changes.
ABIM initially revamped its certification policies beginning in January 2014, shortening the time physicians had to earn MOC points and publishing online whether doctors were meeting requirements. The actions meant every 2 years, physicians certified by ABIM had to earn at least some points by completing some of the educational activities approved for MOC credit, and at the 5-year mark, earn 100 points. Previously, physicians were given 10 years to earn 100 points. Physicians were also listed publicly as either “certified, meeting maintenance of certification requirements” or “certified, not meeting MOC requirements.”
The changes were met with almost immediate backlash. Doctors expressed frustration that the requirements were burdensome, expensive, and irrelevant. By January 2015, a Web-based petition against the program garnered more than 19,000 signatures and has drawn thousands of comments in protest of the new requirements. A second petition had nearly 6,000 signatures with doctors taking a “pledge of noncompliance” with the requirements.
A January perspective piece in the New England Journal of Medicine expressed that the MOC program is essentially a money-generating activity for the ABIM and that the organization has lost contact with the realities of day-to-day clinical practice.
In an interview, Dr. Baron said such feedback drove ABIM to make the changes. He acknowledged that it would take time to build back trust within the community.
“Part of why we’re taking the steps we’re taking is that it’s critical to have trust with the community,” Dr. Baron said. “Part of how you do that is if you got something wrong, you apologize for it, you acknowledge you got it wrong, and you commit to making changes and try to get it right.”
Dr. Wayne J. Riley, ACP president-elect and a clinical professor of medicine at Vanderbilt University in Nashville said the ABIM’s program changes rightly respond to the high level of dissatisfaction and angst with MOC strongly voiced by internists of all stripes.
“The reality of modern medical practice in this dynamic era of health care change really argues for an improved process that better reflects how we practice in various practice settings and which does not threaten livelihoods and professional privileges,” he said in an interview. “With these impending changes, it is my hope that now all ABIM diplomates can embrace with gusto the continuous improvement ideal reflected in certification in a more value-added, time-efficient and more educationally rich manner.”
Dr. Baron noted that ABIM will be working with medical societies and directly with diplomates to seek input regarding the MOC program through meetings, webinars, forums, online communications channels, surveys, and other mediums.
“I fervently hope that we will come together as a community to figure out how to build a program that embodies and actualizes the values that internists have,” he said in the interview. “We’re going to need a lot of community participation to make that work and I hope that people will step up.”
On Twitter @legal_med
In a frank announcement, the American Board of Internal Medicine has apologized to doctors for a Maintenance of Certification program that “clearly got it wrong,” and pledged to make the program more consistent with internists’ practice and values.
Among the immediate changes: updates to its internal medicine exam; suspension of the practice assessment, patient voice, and patient safety requirements for at least 2 years; and MOC enrollment fees set at or below the 2014 levels through at least 2017.
Dr. David A. Fleming, president of the American College of Physicians (ACP), called the move monumental and historic.
“This turnaround has occurred in the face of mounting pressure and discontent expressed by a growing number of U.S. internists concerned about the MOC process,” Dr. Fleming said in an interview. “With the new changes in MOC, internists are still being held accountable and responsible for maintaining professional competence, but by removing the practice assessment and patient [safety] requirements that are not well supported by evidence, we go a long way in taking the pressure off very busy physicians who already feel burdened by many layers of regulatory and administrative reporting that many view as burdensome and a barrier to our first duty – caring for patients.”
In a statement, ABIM President and CEO Dr. Richard J. Baron said it was clear that aspects of the program were not meeting physicians’ needs.
“We got it wrong and sincerely apologize,” Dr. Baron said in the statement. “We are sorry. ABIM is changing the way it does its work so that it is guided by, and integrated fully with, the medical community that created it. The goal is to co-create an MOC program that reflects the medical community’s shared values about the practice of medicine today and provides a professionally created and publicly recognizable framework for keeping up in our discipline.”
As part of the newly announced changes, ABIM will make its internal medicine exam more reflective of physician practice, with changes to be incorporated in fall 2015, according to the announcement. The decision to suspend the practice assessment, patient voice, and patient safety requirements means internists who have not completed activities in these areas will not have their certification status changed. Diplomates who are currently uncertified but who have satisfied all requirements for MOC except for the practice assessment requirement will be issued a new certificate this year. Within the next 6 months, ABIM will also change the language used to publicly report a diplomate’s MOC status on its website from “meeting MOC requirements” to “participating in MOC.”
By the end of 2015, ABIM said it will assure new and more flexible ways for internists to demonstrate self-assessment of medical knowledge by recognizing most forms of Accreditation Council for Continuing Medical Education–approved continuing medical education. An online FAQ provides more information on the changes.
ABIM initially revamped its certification policies beginning in January 2014, shortening the time physicians had to earn MOC points and publishing online whether doctors were meeting requirements. The actions meant every 2 years, physicians certified by ABIM had to earn at least some points by completing some of the educational activities approved for MOC credit, and at the 5-year mark, earn 100 points. Previously, physicians were given 10 years to earn 100 points. Physicians were also listed publicly as either “certified, meeting maintenance of certification requirements” or “certified, not meeting MOC requirements.”
The changes were met with almost immediate backlash. Doctors expressed frustration that the requirements were burdensome, expensive, and irrelevant. By January 2015, a Web-based petition against the program garnered more than 19,000 signatures and has drawn thousands of comments in protest of the new requirements. A second petition had nearly 6,000 signatures with doctors taking a “pledge of noncompliance” with the requirements.
A January perspective piece in the New England Journal of Medicine expressed that the MOC program is essentially a money-generating activity for the ABIM and that the organization has lost contact with the realities of day-to-day clinical practice.
In an interview, Dr. Baron said such feedback drove ABIM to make the changes. He acknowledged that it would take time to build back trust within the community.
“Part of why we’re taking the steps we’re taking is that it’s critical to have trust with the community,” Dr. Baron said. “Part of how you do that is if you got something wrong, you apologize for it, you acknowledge you got it wrong, and you commit to making changes and try to get it right.”
Dr. Wayne J. Riley, ACP president-elect and a clinical professor of medicine at Vanderbilt University in Nashville said the ABIM’s program changes rightly respond to the high level of dissatisfaction and angst with MOC strongly voiced by internists of all stripes.
“The reality of modern medical practice in this dynamic era of health care change really argues for an improved process that better reflects how we practice in various practice settings and which does not threaten livelihoods and professional privileges,” he said in an interview. “With these impending changes, it is my hope that now all ABIM diplomates can embrace with gusto the continuous improvement ideal reflected in certification in a more value-added, time-efficient and more educationally rich manner.”
Dr. Baron noted that ABIM will be working with medical societies and directly with diplomates to seek input regarding the MOC program through meetings, webinars, forums, online communications channels, surveys, and other mediums.
“I fervently hope that we will come together as a community to figure out how to build a program that embodies and actualizes the values that internists have,” he said in the interview. “We’re going to need a lot of community participation to make that work and I hope that people will step up.”
On Twitter @legal_med
In a frank announcement, the American Board of Internal Medicine has apologized to doctors for a Maintenance of Certification program that “clearly got it wrong,” and pledged to make the program more consistent with internists’ practice and values.
Among the immediate changes: updates to its internal medicine exam; suspension of the practice assessment, patient voice, and patient safety requirements for at least 2 years; and MOC enrollment fees set at or below the 2014 levels through at least 2017.
Dr. David A. Fleming, president of the American College of Physicians (ACP), called the move monumental and historic.
“This turnaround has occurred in the face of mounting pressure and discontent expressed by a growing number of U.S. internists concerned about the MOC process,” Dr. Fleming said in an interview. “With the new changes in MOC, internists are still being held accountable and responsible for maintaining professional competence, but by removing the practice assessment and patient [safety] requirements that are not well supported by evidence, we go a long way in taking the pressure off very busy physicians who already feel burdened by many layers of regulatory and administrative reporting that many view as burdensome and a barrier to our first duty – caring for patients.”
In a statement, ABIM President and CEO Dr. Richard J. Baron said it was clear that aspects of the program were not meeting physicians’ needs.
“We got it wrong and sincerely apologize,” Dr. Baron said in the statement. “We are sorry. ABIM is changing the way it does its work so that it is guided by, and integrated fully with, the medical community that created it. The goal is to co-create an MOC program that reflects the medical community’s shared values about the practice of medicine today and provides a professionally created and publicly recognizable framework for keeping up in our discipline.”
As part of the newly announced changes, ABIM will make its internal medicine exam more reflective of physician practice, with changes to be incorporated in fall 2015, according to the announcement. The decision to suspend the practice assessment, patient voice, and patient safety requirements means internists who have not completed activities in these areas will not have their certification status changed. Diplomates who are currently uncertified but who have satisfied all requirements for MOC except for the practice assessment requirement will be issued a new certificate this year. Within the next 6 months, ABIM will also change the language used to publicly report a diplomate’s MOC status on its website from “meeting MOC requirements” to “participating in MOC.”
By the end of 2015, ABIM said it will assure new and more flexible ways for internists to demonstrate self-assessment of medical knowledge by recognizing most forms of Accreditation Council for Continuing Medical Education–approved continuing medical education. An online FAQ provides more information on the changes.
ABIM initially revamped its certification policies beginning in January 2014, shortening the time physicians had to earn MOC points and publishing online whether doctors were meeting requirements. The actions meant every 2 years, physicians certified by ABIM had to earn at least some points by completing some of the educational activities approved for MOC credit, and at the 5-year mark, earn 100 points. Previously, physicians were given 10 years to earn 100 points. Physicians were also listed publicly as either “certified, meeting maintenance of certification requirements” or “certified, not meeting MOC requirements.”
The changes were met with almost immediate backlash. Doctors expressed frustration that the requirements were burdensome, expensive, and irrelevant. By January 2015, a Web-based petition against the program garnered more than 19,000 signatures and has drawn thousands of comments in protest of the new requirements. A second petition had nearly 6,000 signatures with doctors taking a “pledge of noncompliance” with the requirements.
A January perspective piece in the New England Journal of Medicine expressed that the MOC program is essentially a money-generating activity for the ABIM and that the organization has lost contact with the realities of day-to-day clinical practice.
In an interview, Dr. Baron said such feedback drove ABIM to make the changes. He acknowledged that it would take time to build back trust within the community.
“Part of why we’re taking the steps we’re taking is that it’s critical to have trust with the community,” Dr. Baron said. “Part of how you do that is if you got something wrong, you apologize for it, you acknowledge you got it wrong, and you commit to making changes and try to get it right.”
Dr. Wayne J. Riley, ACP president-elect and a clinical professor of medicine at Vanderbilt University in Nashville said the ABIM’s program changes rightly respond to the high level of dissatisfaction and angst with MOC strongly voiced by internists of all stripes.
“The reality of modern medical practice in this dynamic era of health care change really argues for an improved process that better reflects how we practice in various practice settings and which does not threaten livelihoods and professional privileges,” he said in an interview. “With these impending changes, it is my hope that now all ABIM diplomates can embrace with gusto the continuous improvement ideal reflected in certification in a more value-added, time-efficient and more educationally rich manner.”
Dr. Baron noted that ABIM will be working with medical societies and directly with diplomates to seek input regarding the MOC program through meetings, webinars, forums, online communications channels, surveys, and other mediums.
“I fervently hope that we will come together as a community to figure out how to build a program that embodies and actualizes the values that internists have,” he said in the interview. “We’re going to need a lot of community participation to make that work and I hope that people will step up.”
On Twitter @legal_med
Study: Surgical readmissions tied to new discharge complications, not prior conditions
Surgical site infection and ileus were the most frequent reason for hospital readmission within 30 days, according to an analysis of data from the National Surgical Quality Improvement Program.
The findings, published online in the Feb. 3 JAMA, suggest that policies that penalize hospitals for readmissions may be ineffective and potentially counterproductive.
Dr. Karl Y. Bilimoria of Northwestern University, Chicago, and his colleagues examined patient data from 346 hospitals participating in the American College of Surgeon’s National Surgical Quality Improvement Program (ACS NSQIP) between January 2012 and December 2012. Readmission rates and reasons were assessed for all surgical procedures and for six representative operations: bariatric surgery, colectomy or proctectomy, hysterectomy, total hip or knee arthroplasty, ventral hernia repair, and lower extremity vascular bypass (JAMA 2015;313;483-95 [doi:10.1001/jama.2014.18614]).
Of the 498, 875 patient sample, the overall readmission rate was 5.7%. For individual procedures, the readmission rate ranged from 3.8% for hysterectomy to 14.9% for lower extremity vascular bypass.
The most common reason for readmission was surgical site infection (SSI; 19.5%), ranging from 11.4% after bariatric surgery to 36.4% after lower extremity vascular bypass. Ileus was the most common reason for readmission after bariatric surgery (24.5%) and the second most common reason overall (10.3%). Other common causes for readmission included dehydration or nutritional deficiency, bleeding or anemia, venous thromboembolism, and prosthesis or graft issues (after arthroplasty and lower extremity vascular bypass procedures). Only 2% of patients were readmitted for the same complication they had experienced during their index hospitalization. Just 3% of patients readmitted for SSIs had experienced an SSI during their index hospitalization.
The results show readmissions after surgery may not be an appropriate measure for pay-for-performance and cost-containment programs, such as the Centers for Medicare & Medicaid Service’s Hospital Readmissions Reduction Program, Dr. Bilimoria said. Performance targets without accepted courses of intervention might be more prone to unintended or ineffective behaviors and consequences, he noted.
“Surgical readmissions mostly reflect postdischarge complications, and readmission rates may be difficult to reduce until effective strategies are put forth to reduce common complications such as SSI,” he said. “Efforts should focus on reducing complication rates overall than simply those that occur after discharge, and this will subsequently reduce readmission rates as well.”
On Twitter @legal_med
These findings provide an unprecedented opportunity to apply these lessons and make substantial reductions in surgical complications, Dr. Lucian L. Leape said in an editorial accompanying the study.
Changing systems is hard work and requires serious commitment. Changing hospital systems is especially difficult because of long-standing traditions and entrenched practices. Successful change requires leadership by those with the will, the determination, and the perseverance to overcome obstacles and motivate colleagues. It requires commitment, which comes from a sense of urgency and a sense of possibility.
One way to develop a sense of urgency is to translate rates into numbers – i.e., actual patients. For example, in this study, surgical site infections accounted for 19.5% of the unplanned readmissions. Even though this only represents 1% of the 498,875 ACS NSQIP patients undergoing surgery in 2012, that 1% equals 5,565 patients. Reducing that number by half would reduce pain and suffering for more than 2,700 patients. If similar success were achieved nationwide, the total would be many times that.
Dr. Lucian L. Leape is with the department of health policy and management at Harvard School of Public Health, Boston, and made these comments in an accompanying editorial (doi:10.1001/jama.2014.18666). He reported having no relevant financial disclosures.
These findings provide an unprecedented opportunity to apply these lessons and make substantial reductions in surgical complications, Dr. Lucian L. Leape said in an editorial accompanying the study.
Changing systems is hard work and requires serious commitment. Changing hospital systems is especially difficult because of long-standing traditions and entrenched practices. Successful change requires leadership by those with the will, the determination, and the perseverance to overcome obstacles and motivate colleagues. It requires commitment, which comes from a sense of urgency and a sense of possibility.
One way to develop a sense of urgency is to translate rates into numbers – i.e., actual patients. For example, in this study, surgical site infections accounted for 19.5% of the unplanned readmissions. Even though this only represents 1% of the 498,875 ACS NSQIP patients undergoing surgery in 2012, that 1% equals 5,565 patients. Reducing that number by half would reduce pain and suffering for more than 2,700 patients. If similar success were achieved nationwide, the total would be many times that.
Dr. Lucian L. Leape is with the department of health policy and management at Harvard School of Public Health, Boston, and made these comments in an accompanying editorial (doi:10.1001/jama.2014.18666). He reported having no relevant financial disclosures.
These findings provide an unprecedented opportunity to apply these lessons and make substantial reductions in surgical complications, Dr. Lucian L. Leape said in an editorial accompanying the study.
Changing systems is hard work and requires serious commitment. Changing hospital systems is especially difficult because of long-standing traditions and entrenched practices. Successful change requires leadership by those with the will, the determination, and the perseverance to overcome obstacles and motivate colleagues. It requires commitment, which comes from a sense of urgency and a sense of possibility.
One way to develop a sense of urgency is to translate rates into numbers – i.e., actual patients. For example, in this study, surgical site infections accounted for 19.5% of the unplanned readmissions. Even though this only represents 1% of the 498,875 ACS NSQIP patients undergoing surgery in 2012, that 1% equals 5,565 patients. Reducing that number by half would reduce pain and suffering for more than 2,700 patients. If similar success were achieved nationwide, the total would be many times that.
Dr. Lucian L. Leape is with the department of health policy and management at Harvard School of Public Health, Boston, and made these comments in an accompanying editorial (doi:10.1001/jama.2014.18666). He reported having no relevant financial disclosures.
Surgical site infection and ileus were the most frequent reason for hospital readmission within 30 days, according to an analysis of data from the National Surgical Quality Improvement Program.
The findings, published online in the Feb. 3 JAMA, suggest that policies that penalize hospitals for readmissions may be ineffective and potentially counterproductive.
Dr. Karl Y. Bilimoria of Northwestern University, Chicago, and his colleagues examined patient data from 346 hospitals participating in the American College of Surgeon’s National Surgical Quality Improvement Program (ACS NSQIP) between January 2012 and December 2012. Readmission rates and reasons were assessed for all surgical procedures and for six representative operations: bariatric surgery, colectomy or proctectomy, hysterectomy, total hip or knee arthroplasty, ventral hernia repair, and lower extremity vascular bypass (JAMA 2015;313;483-95 [doi:10.1001/jama.2014.18614]).
Of the 498, 875 patient sample, the overall readmission rate was 5.7%. For individual procedures, the readmission rate ranged from 3.8% for hysterectomy to 14.9% for lower extremity vascular bypass.
The most common reason for readmission was surgical site infection (SSI; 19.5%), ranging from 11.4% after bariatric surgery to 36.4% after lower extremity vascular bypass. Ileus was the most common reason for readmission after bariatric surgery (24.5%) and the second most common reason overall (10.3%). Other common causes for readmission included dehydration or nutritional deficiency, bleeding or anemia, venous thromboembolism, and prosthesis or graft issues (after arthroplasty and lower extremity vascular bypass procedures). Only 2% of patients were readmitted for the same complication they had experienced during their index hospitalization. Just 3% of patients readmitted for SSIs had experienced an SSI during their index hospitalization.
The results show readmissions after surgery may not be an appropriate measure for pay-for-performance and cost-containment programs, such as the Centers for Medicare & Medicaid Service’s Hospital Readmissions Reduction Program, Dr. Bilimoria said. Performance targets without accepted courses of intervention might be more prone to unintended or ineffective behaviors and consequences, he noted.
“Surgical readmissions mostly reflect postdischarge complications, and readmission rates may be difficult to reduce until effective strategies are put forth to reduce common complications such as SSI,” he said. “Efforts should focus on reducing complication rates overall than simply those that occur after discharge, and this will subsequently reduce readmission rates as well.”
On Twitter @legal_med
Surgical site infection and ileus were the most frequent reason for hospital readmission within 30 days, according to an analysis of data from the National Surgical Quality Improvement Program.
The findings, published online in the Feb. 3 JAMA, suggest that policies that penalize hospitals for readmissions may be ineffective and potentially counterproductive.
Dr. Karl Y. Bilimoria of Northwestern University, Chicago, and his colleagues examined patient data from 346 hospitals participating in the American College of Surgeon’s National Surgical Quality Improvement Program (ACS NSQIP) between January 2012 and December 2012. Readmission rates and reasons were assessed for all surgical procedures and for six representative operations: bariatric surgery, colectomy or proctectomy, hysterectomy, total hip or knee arthroplasty, ventral hernia repair, and lower extremity vascular bypass (JAMA 2015;313;483-95 [doi:10.1001/jama.2014.18614]).
Of the 498, 875 patient sample, the overall readmission rate was 5.7%. For individual procedures, the readmission rate ranged from 3.8% for hysterectomy to 14.9% for lower extremity vascular bypass.
The most common reason for readmission was surgical site infection (SSI; 19.5%), ranging from 11.4% after bariatric surgery to 36.4% after lower extremity vascular bypass. Ileus was the most common reason for readmission after bariatric surgery (24.5%) and the second most common reason overall (10.3%). Other common causes for readmission included dehydration or nutritional deficiency, bleeding or anemia, venous thromboembolism, and prosthesis or graft issues (after arthroplasty and lower extremity vascular bypass procedures). Only 2% of patients were readmitted for the same complication they had experienced during their index hospitalization. Just 3% of patients readmitted for SSIs had experienced an SSI during their index hospitalization.
The results show readmissions after surgery may not be an appropriate measure for pay-for-performance and cost-containment programs, such as the Centers for Medicare & Medicaid Service’s Hospital Readmissions Reduction Program, Dr. Bilimoria said. Performance targets without accepted courses of intervention might be more prone to unintended or ineffective behaviors and consequences, he noted.
“Surgical readmissions mostly reflect postdischarge complications, and readmission rates may be difficult to reduce until effective strategies are put forth to reduce common complications such as SSI,” he said. “Efforts should focus on reducing complication rates overall than simply those that occur after discharge, and this will subsequently reduce readmission rates as well.”
On Twitter @legal_med
Key clinical point: The majority of 30-day readmissions after surgery are associated with new postdischarge complications and not the worsening of medical conditions patients had when initially hospitalized.
Major finding: Of 498,875 patients, the overall unplanned readmission rate was 5.7%. Only 2% of patients were readmitted for the same complication they had experienced during their index hospitalization. The most common reason for readmission was surgical site infections (19.5%).
Data source: A study of 346 hospitals participating in the American College of Surgeon’s National Surgical Quality Improvement Program (ACS NSQIP) between January and December 2012.
Disclosures: The investigators reported no relevant conflicts of interest.
President’s budget would extend Medicaid pay bump, repeal SGR
President Barack Obama’s 2016 budget calls for extending the Medicaid pay bump for primary care physicians, improving access to health providers, and installing a permanent fix to Medicare’s Sustainable Growth Rate reimbursement formula.
The president outlined his nearly $4 trillion budget in a summary released Feb. 2 by the White House. The proposal includes extending increased payments for primary care services delivered by physicians who accept Medicaid through 2016, with modifications to expand provider eligibility. The president also wants to enhance training of primary care practitioners and other physicians in high-need specialties by providing $5.25 billion over 10 years to support 13,000 new medical school graduate residents through a new graduate medical education program.
In addition, the president is seeking the end of sequestration, the broad federal cuts triggered by the Budget Control Act of 2011. During a Feb. 2 news conference, the president stressed that the deficit reduction achieved during his presidency – a reported cut of two-thirds – makes his budget proposals possible.
“We can afford to make these investments, while remaining fiscally responsible,” President Obama said during the conference. “In fact, we would be making a critical error if we avoided making these investments.”
The president’s budget includes a number of recommendations that would cut billions in Medicare funding over the next 10 years.
The budget would reduce the projected growth of Medicare payments for graduate medical education by $16 billion, while saving more than $100 billion by reducing inflation updates for providers who treat Medicare beneficiaries after they leave the hospital. Meanwhile, improving payment accuracy for the Medicare Advantage program would result in $43 billion in savings over 10 years, according to the plan.
The proposal also seeks to extend funding for the Children’s Health Insurance Program (CHIP) through 2019 and give states the option to streamline eligibility determinations for children in Medicaid and CHIP.
The president said he wants to accelerate physician participation in high-quality and efficient health care delivery systems by repealing the SGR and reforming Medicare physician payments consistent with recent bipartisan legislation. Obama also suggested extending increased Medicaid payments to primary care physicians through 2016 at a cost of $6.3 billion.
Other medical and public health care proposals include:
• Directing more than $100 million to reduce abuse of prescription opioids and $4.2 billion to the Health Center Program to expand services to an additional 1 million patients.
• Funding increases for every state to expand existing prescription drug monitoring programs, and funding increases for the Centers for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration, and the Agency for Healthcare Research and Quality to decrease the rates of inappropriate prescription drug abuse.
• An increase of more than $550 million above 2015 enacted levels across the federal government to prevent, detect, and control illness and death related to infections caused by antibiotic-resistant bacteria.
• More than $500 million to enhance the advanced development of next-generation medical countermeasures against chemical, biologic, radiologic, and nuclear threats.
• A 6% spending increase in medical research and development to fuel programs such as the Precision Medicine Initiative and the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative.
• Increased access to generic drugs by stopping companies from entering into anticompetitive deals intended to block consumer access to generics.
The administration contends the budget will trim the deficit by $1.8 trillion over the next decade, primarily because of health, tax, and immigration reforms. That includes $400 billion in health savings that would grow over time – raising about $1 trillion in the second decade and extending the Medicare hospital insurance trust fund solvency by about 5 years, the president said.
Republican lawmakers criticized the budget proposal, calling it a repeat of past failures.
“Today President Obama laid out a plan for more taxes, more spending, and more of the Washington gridlock that has failed middle-class families,” House Speaker John Boehner (R-Ohio) said in a statement. “It may be Groundhog Day, but the American people can’t afford a repeat of the same old top-down policies of the past. Like the president’s previous budgets, this plan never balances – ever.”
Liberal groups, such as the Center for American Progress, praised the budget proposal.
“President Obama’s budget lays out a detailed agenda to create good jobs, raise wages, and help working families achieve middle-class security,” Carmel Martin, the center’s executive vice president, said in a statement. “Rather than stumbling through a series of unnecessary manufactured crises or clinging to failed austerity measures such as sequestration, Congress has an opportunity to work with President Obama to build an economy that works for everyone, not just the wealthy few.”
On Twitter @legal_med
President Barack Obama’s 2016 budget calls for extending the Medicaid pay bump for primary care physicians, improving access to health providers, and installing a permanent fix to Medicare’s Sustainable Growth Rate reimbursement formula.
The president outlined his nearly $4 trillion budget in a summary released Feb. 2 by the White House. The proposal includes extending increased payments for primary care services delivered by physicians who accept Medicaid through 2016, with modifications to expand provider eligibility. The president also wants to enhance training of primary care practitioners and other physicians in high-need specialties by providing $5.25 billion over 10 years to support 13,000 new medical school graduate residents through a new graduate medical education program.
In addition, the president is seeking the end of sequestration, the broad federal cuts triggered by the Budget Control Act of 2011. During a Feb. 2 news conference, the president stressed that the deficit reduction achieved during his presidency – a reported cut of two-thirds – makes his budget proposals possible.
“We can afford to make these investments, while remaining fiscally responsible,” President Obama said during the conference. “In fact, we would be making a critical error if we avoided making these investments.”
The president’s budget includes a number of recommendations that would cut billions in Medicare funding over the next 10 years.
The budget would reduce the projected growth of Medicare payments for graduate medical education by $16 billion, while saving more than $100 billion by reducing inflation updates for providers who treat Medicare beneficiaries after they leave the hospital. Meanwhile, improving payment accuracy for the Medicare Advantage program would result in $43 billion in savings over 10 years, according to the plan.
The proposal also seeks to extend funding for the Children’s Health Insurance Program (CHIP) through 2019 and give states the option to streamline eligibility determinations for children in Medicaid and CHIP.
The president said he wants to accelerate physician participation in high-quality and efficient health care delivery systems by repealing the SGR and reforming Medicare physician payments consistent with recent bipartisan legislation. Obama also suggested extending increased Medicaid payments to primary care physicians through 2016 at a cost of $6.3 billion.
Other medical and public health care proposals include:
• Directing more than $100 million to reduce abuse of prescription opioids and $4.2 billion to the Health Center Program to expand services to an additional 1 million patients.
• Funding increases for every state to expand existing prescription drug monitoring programs, and funding increases for the Centers for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration, and the Agency for Healthcare Research and Quality to decrease the rates of inappropriate prescription drug abuse.
• An increase of more than $550 million above 2015 enacted levels across the federal government to prevent, detect, and control illness and death related to infections caused by antibiotic-resistant bacteria.
• More than $500 million to enhance the advanced development of next-generation medical countermeasures against chemical, biologic, radiologic, and nuclear threats.
• A 6% spending increase in medical research and development to fuel programs such as the Precision Medicine Initiative and the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative.
• Increased access to generic drugs by stopping companies from entering into anticompetitive deals intended to block consumer access to generics.
The administration contends the budget will trim the deficit by $1.8 trillion over the next decade, primarily because of health, tax, and immigration reforms. That includes $400 billion in health savings that would grow over time – raising about $1 trillion in the second decade and extending the Medicare hospital insurance trust fund solvency by about 5 years, the president said.
Republican lawmakers criticized the budget proposal, calling it a repeat of past failures.
“Today President Obama laid out a plan for more taxes, more spending, and more of the Washington gridlock that has failed middle-class families,” House Speaker John Boehner (R-Ohio) said in a statement. “It may be Groundhog Day, but the American people can’t afford a repeat of the same old top-down policies of the past. Like the president’s previous budgets, this plan never balances – ever.”
Liberal groups, such as the Center for American Progress, praised the budget proposal.
“President Obama’s budget lays out a detailed agenda to create good jobs, raise wages, and help working families achieve middle-class security,” Carmel Martin, the center’s executive vice president, said in a statement. “Rather than stumbling through a series of unnecessary manufactured crises or clinging to failed austerity measures such as sequestration, Congress has an opportunity to work with President Obama to build an economy that works for everyone, not just the wealthy few.”
On Twitter @legal_med
President Barack Obama’s 2016 budget calls for extending the Medicaid pay bump for primary care physicians, improving access to health providers, and installing a permanent fix to Medicare’s Sustainable Growth Rate reimbursement formula.
The president outlined his nearly $4 trillion budget in a summary released Feb. 2 by the White House. The proposal includes extending increased payments for primary care services delivered by physicians who accept Medicaid through 2016, with modifications to expand provider eligibility. The president also wants to enhance training of primary care practitioners and other physicians in high-need specialties by providing $5.25 billion over 10 years to support 13,000 new medical school graduate residents through a new graduate medical education program.
In addition, the president is seeking the end of sequestration, the broad federal cuts triggered by the Budget Control Act of 2011. During a Feb. 2 news conference, the president stressed that the deficit reduction achieved during his presidency – a reported cut of two-thirds – makes his budget proposals possible.
“We can afford to make these investments, while remaining fiscally responsible,” President Obama said during the conference. “In fact, we would be making a critical error if we avoided making these investments.”
The president’s budget includes a number of recommendations that would cut billions in Medicare funding over the next 10 years.
The budget would reduce the projected growth of Medicare payments for graduate medical education by $16 billion, while saving more than $100 billion by reducing inflation updates for providers who treat Medicare beneficiaries after they leave the hospital. Meanwhile, improving payment accuracy for the Medicare Advantage program would result in $43 billion in savings over 10 years, according to the plan.
The proposal also seeks to extend funding for the Children’s Health Insurance Program (CHIP) through 2019 and give states the option to streamline eligibility determinations for children in Medicaid and CHIP.
The president said he wants to accelerate physician participation in high-quality and efficient health care delivery systems by repealing the SGR and reforming Medicare physician payments consistent with recent bipartisan legislation. Obama also suggested extending increased Medicaid payments to primary care physicians through 2016 at a cost of $6.3 billion.
Other medical and public health care proposals include:
• Directing more than $100 million to reduce abuse of prescription opioids and $4.2 billion to the Health Center Program to expand services to an additional 1 million patients.
• Funding increases for every state to expand existing prescription drug monitoring programs, and funding increases for the Centers for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration, and the Agency for Healthcare Research and Quality to decrease the rates of inappropriate prescription drug abuse.
• An increase of more than $550 million above 2015 enacted levels across the federal government to prevent, detect, and control illness and death related to infections caused by antibiotic-resistant bacteria.
• More than $500 million to enhance the advanced development of next-generation medical countermeasures against chemical, biologic, radiologic, and nuclear threats.
• A 6% spending increase in medical research and development to fuel programs such as the Precision Medicine Initiative and the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative.
• Increased access to generic drugs by stopping companies from entering into anticompetitive deals intended to block consumer access to generics.
The administration contends the budget will trim the deficit by $1.8 trillion over the next decade, primarily because of health, tax, and immigration reforms. That includes $400 billion in health savings that would grow over time – raising about $1 trillion in the second decade and extending the Medicare hospital insurance trust fund solvency by about 5 years, the president said.
Republican lawmakers criticized the budget proposal, calling it a repeat of past failures.
“Today President Obama laid out a plan for more taxes, more spending, and more of the Washington gridlock that has failed middle-class families,” House Speaker John Boehner (R-Ohio) said in a statement. “It may be Groundhog Day, but the American people can’t afford a repeat of the same old top-down policies of the past. Like the president’s previous budgets, this plan never balances – ever.”
Liberal groups, such as the Center for American Progress, praised the budget proposal.
“President Obama’s budget lays out a detailed agenda to create good jobs, raise wages, and help working families achieve middle-class security,” Carmel Martin, the center’s executive vice president, said in a statement. “Rather than stumbling through a series of unnecessary manufactured crises or clinging to failed austerity measures such as sequestration, Congress has an opportunity to work with President Obama to build an economy that works for everyone, not just the wealthy few.”
On Twitter @legal_med
Medicare at 50: Hassles lead to doctor opt-outs, new business models
After suffering through reduced reimbursement year after year and encountering government rules that caused her to restrict the way she practiced, Atlanta otolaryngologist Dr. Elaina George was fed up with Medicare and what seemed its endless red tape.
“We found that the time it took to be reimbursed was much longer than the average commercial payer,” Dr. George said in an interview. Because of global period payment rules, “several times, we got paid nothing. [Medicare] stopped me from doing the things I was trained to do. I stopped doing head and neck surgeries because it wasn’t cost effective.”
Instead of complaining or appealing payment decisions, Dr. George made a more drastic move. She dropped Medicare altogether. Nearly a decade later, the solo practitioner continues to opt out of Medicare, obtaining payment through some commercial insurers and direct pay contracts with patients.
“Direct pay is going to be the future, and anybody who can figure out how to work around the (traditional) insurance model is going to save money,” said Dr. George, an advisory council member of Project 21 black leadership network, an initiative of the National Center for Public Policy Research, a conservative think tank and policy institute.
Dr. George is far from alone. She is part of a growing vocal minority that says dropping Medicare is the only remedy to ongoing payment reductions, extended waits for reimbursement, audits, and growing regulations, such as meaningful use. The feasibility of leaving the program however, depends on specialty, geographic location, and patient base, physician leaders say.
Measuring the number of doctors who opt out of Medicare isn’t easy. The U.S. Department of Health & Human Service’s Office of Inspector General (OIG) said in a 2012 letter to the Centers for Medicare & Medicaid Services (CMS) that CMS does not maintain sufficient data regarding physicians who opt out of Medicare, and therefore the OIG could not complete an analysis into reasons doctors choose not to participate.
However, federal data released to the Wall Street Journal in 2013 show that 9,539 physicians who previously accepted Medicare opted out of the program in 2012, up from 3,700 in 2009. The CMS had never before released annual opt-out figures, and the data cannot be found on CMS’ website. A CMS spokeswoman declined comment for this story.
Despite the drop-out figures, government statistics paint a picture of growing physician participation in Medicare. A 2014 CMS report shows that a total of 1,226,728 health providers of all specialties participated in Medicare in 2013, up from 1,089,306 in 2012, according to federal data. (The report noted physicians may have been counted in more than one specialty.) There were 219,536 primary care physicians/suppliers who treated Medicare patients in 2013, up from 215,919 in 2012.
But the stats on physician participation do not tell the whole story, said Dr. Austin King, president of the Texas Medical Association and an Abilene otolaryngologist. While many physicians take Medicare patients, he notes that a large portion do not accept new Medicare patients. In Abilene for example, Dr. King said he knows of no internists who accept new Medicare patients. The dilemma means as more of the population reaches Medicare age, there could be fewer doctors to treat them.
“It seems like the government is almost making it more difficult for physicians to treat Medicare patients,” said Dr. King, who limits the number of Medicare patients he treats. “It’s difficult for many reasons, but what I hear most are complaints about the enormous amount of red tape and bureaucracy associated with Medicare.”
For family physician Dr. Andrew Merritt of Marcellus, N.Y., the decision not to accept new Medicare patients made sense 15 years ago and still does today. Medicare is one of the lowest payers in the Marcellus area, he said, second only to Medicaid.
“The trends were there” back in 2000 when he made the decision, he said. “For us, it was fees and regulations, and the regulations have gotten worse.”
The government disputes that more doctors are rejecting new Medicare patients. The percentage of all office-based physicians who report accepting new Medicare patients has not changed significantly between 2005 and 2012, with 87.9% of physicians accepting new Medicare patients in 2005 and 90.7% accepting new patients in 2012, according to a 2013 issue brief from the HHS Office of the Assistant Secretary for Planning and Evaluation. The percentage of doctors accepting new Medicare patients in 2011-2012 is slightly higher than the percentage accepting new private insurance – about 86% of physicians in 2012 accepted new privately insured patients, according to the brief.
“To the extent that there may have been a very small increase in the number of providers ‘opting out,’ that increase has been mitigated by an increase in the share of other physicians who accept new Medicare patients,” according to the issue brief. “Further, the total number of providers participating in and billing Medicare has steadily increased since 2007.”
Dr. Merritt notes while opting out of Medicare might work for some physicians, it’s not practical for all. For instance, in his area, most psychiatrists have opted out of Medicare. “In primary care, it becomes difficult,” he said. “You have to see a lot of people, and it depends on the level of competition.”
Similarly, where a doctor practices impacts Medicare participation, said Dr. Theodore Mazer, a San Diego otolaryngologist and house of delegates speaker at the California Medical Association.
“In my area, Medicare payment is kind of a gold standard,” he said in an interview. “There’s not much that pays better than that. If I can’t pay costs with Medicare, that means I can’t pay costs with any carrier in the area.”
The Association of American Physicians and Surgeons (AAPS) on the other hand, believes with some assessment and planning, most physicians could successfully opt out of Medicare. The AAPS has been hosting a series of workshops and presentations on how to drop Medicare and move to a cash-only practice.
When considering the transition, physicians need to examine their patient base, practice demographics and costs with and without Medicare, said Dr. Lawrence Huntoon, editor-in-chief of the Journal of the Association of American Physicians and Surgeons. He notes a significant amount of professional time and money is often spent on Medicare-related paperwork and administrative burdens.
Dr. Huntoon stopped participating in Medicare in 2004. His practice works with no third-party insurers, including Medicare, and contracts directly with patients for payment.
“I’m very happy with it, and I’ve never regretted it,” he said in an interview. “You just don’t have someone constantly interfering with the care you’re trying to provide.”
On Twitter @legal_med
After suffering through reduced reimbursement year after year and encountering government rules that caused her to restrict the way she practiced, Atlanta otolaryngologist Dr. Elaina George was fed up with Medicare and what seemed its endless red tape.
“We found that the time it took to be reimbursed was much longer than the average commercial payer,” Dr. George said in an interview. Because of global period payment rules, “several times, we got paid nothing. [Medicare] stopped me from doing the things I was trained to do. I stopped doing head and neck surgeries because it wasn’t cost effective.”
Instead of complaining or appealing payment decisions, Dr. George made a more drastic move. She dropped Medicare altogether. Nearly a decade later, the solo practitioner continues to opt out of Medicare, obtaining payment through some commercial insurers and direct pay contracts with patients.
“Direct pay is going to be the future, and anybody who can figure out how to work around the (traditional) insurance model is going to save money,” said Dr. George, an advisory council member of Project 21 black leadership network, an initiative of the National Center for Public Policy Research, a conservative think tank and policy institute.
Dr. George is far from alone. She is part of a growing vocal minority that says dropping Medicare is the only remedy to ongoing payment reductions, extended waits for reimbursement, audits, and growing regulations, such as meaningful use. The feasibility of leaving the program however, depends on specialty, geographic location, and patient base, physician leaders say.
Measuring the number of doctors who opt out of Medicare isn’t easy. The U.S. Department of Health & Human Service’s Office of Inspector General (OIG) said in a 2012 letter to the Centers for Medicare & Medicaid Services (CMS) that CMS does not maintain sufficient data regarding physicians who opt out of Medicare, and therefore the OIG could not complete an analysis into reasons doctors choose not to participate.
However, federal data released to the Wall Street Journal in 2013 show that 9,539 physicians who previously accepted Medicare opted out of the program in 2012, up from 3,700 in 2009. The CMS had never before released annual opt-out figures, and the data cannot be found on CMS’ website. A CMS spokeswoman declined comment for this story.
Despite the drop-out figures, government statistics paint a picture of growing physician participation in Medicare. A 2014 CMS report shows that a total of 1,226,728 health providers of all specialties participated in Medicare in 2013, up from 1,089,306 in 2012, according to federal data. (The report noted physicians may have been counted in more than one specialty.) There were 219,536 primary care physicians/suppliers who treated Medicare patients in 2013, up from 215,919 in 2012.
But the stats on physician participation do not tell the whole story, said Dr. Austin King, president of the Texas Medical Association and an Abilene otolaryngologist. While many physicians take Medicare patients, he notes that a large portion do not accept new Medicare patients. In Abilene for example, Dr. King said he knows of no internists who accept new Medicare patients. The dilemma means as more of the population reaches Medicare age, there could be fewer doctors to treat them.
“It seems like the government is almost making it more difficult for physicians to treat Medicare patients,” said Dr. King, who limits the number of Medicare patients he treats. “It’s difficult for many reasons, but what I hear most are complaints about the enormous amount of red tape and bureaucracy associated with Medicare.”
For family physician Dr. Andrew Merritt of Marcellus, N.Y., the decision not to accept new Medicare patients made sense 15 years ago and still does today. Medicare is one of the lowest payers in the Marcellus area, he said, second only to Medicaid.
“The trends were there” back in 2000 when he made the decision, he said. “For us, it was fees and regulations, and the regulations have gotten worse.”
The government disputes that more doctors are rejecting new Medicare patients. The percentage of all office-based physicians who report accepting new Medicare patients has not changed significantly between 2005 and 2012, with 87.9% of physicians accepting new Medicare patients in 2005 and 90.7% accepting new patients in 2012, according to a 2013 issue brief from the HHS Office of the Assistant Secretary for Planning and Evaluation. The percentage of doctors accepting new Medicare patients in 2011-2012 is slightly higher than the percentage accepting new private insurance – about 86% of physicians in 2012 accepted new privately insured patients, according to the brief.
“To the extent that there may have been a very small increase in the number of providers ‘opting out,’ that increase has been mitigated by an increase in the share of other physicians who accept new Medicare patients,” according to the issue brief. “Further, the total number of providers participating in and billing Medicare has steadily increased since 2007.”
Dr. Merritt notes while opting out of Medicare might work for some physicians, it’s not practical for all. For instance, in his area, most psychiatrists have opted out of Medicare. “In primary care, it becomes difficult,” he said. “You have to see a lot of people, and it depends on the level of competition.”
Similarly, where a doctor practices impacts Medicare participation, said Dr. Theodore Mazer, a San Diego otolaryngologist and house of delegates speaker at the California Medical Association.
“In my area, Medicare payment is kind of a gold standard,” he said in an interview. “There’s not much that pays better than that. If I can’t pay costs with Medicare, that means I can’t pay costs with any carrier in the area.”
The Association of American Physicians and Surgeons (AAPS) on the other hand, believes with some assessment and planning, most physicians could successfully opt out of Medicare. The AAPS has been hosting a series of workshops and presentations on how to drop Medicare and move to a cash-only practice.
When considering the transition, physicians need to examine their patient base, practice demographics and costs with and without Medicare, said Dr. Lawrence Huntoon, editor-in-chief of the Journal of the Association of American Physicians and Surgeons. He notes a significant amount of professional time and money is often spent on Medicare-related paperwork and administrative burdens.
Dr. Huntoon stopped participating in Medicare in 2004. His practice works with no third-party insurers, including Medicare, and contracts directly with patients for payment.
“I’m very happy with it, and I’ve never regretted it,” he said in an interview. “You just don’t have someone constantly interfering with the care you’re trying to provide.”
On Twitter @legal_med
After suffering through reduced reimbursement year after year and encountering government rules that caused her to restrict the way she practiced, Atlanta otolaryngologist Dr. Elaina George was fed up with Medicare and what seemed its endless red tape.
“We found that the time it took to be reimbursed was much longer than the average commercial payer,” Dr. George said in an interview. Because of global period payment rules, “several times, we got paid nothing. [Medicare] stopped me from doing the things I was trained to do. I stopped doing head and neck surgeries because it wasn’t cost effective.”
Instead of complaining or appealing payment decisions, Dr. George made a more drastic move. She dropped Medicare altogether. Nearly a decade later, the solo practitioner continues to opt out of Medicare, obtaining payment through some commercial insurers and direct pay contracts with patients.
“Direct pay is going to be the future, and anybody who can figure out how to work around the (traditional) insurance model is going to save money,” said Dr. George, an advisory council member of Project 21 black leadership network, an initiative of the National Center for Public Policy Research, a conservative think tank and policy institute.
Dr. George is far from alone. She is part of a growing vocal minority that says dropping Medicare is the only remedy to ongoing payment reductions, extended waits for reimbursement, audits, and growing regulations, such as meaningful use. The feasibility of leaving the program however, depends on specialty, geographic location, and patient base, physician leaders say.
Measuring the number of doctors who opt out of Medicare isn’t easy. The U.S. Department of Health & Human Service’s Office of Inspector General (OIG) said in a 2012 letter to the Centers for Medicare & Medicaid Services (CMS) that CMS does not maintain sufficient data regarding physicians who opt out of Medicare, and therefore the OIG could not complete an analysis into reasons doctors choose not to participate.
However, federal data released to the Wall Street Journal in 2013 show that 9,539 physicians who previously accepted Medicare opted out of the program in 2012, up from 3,700 in 2009. The CMS had never before released annual opt-out figures, and the data cannot be found on CMS’ website. A CMS spokeswoman declined comment for this story.
Despite the drop-out figures, government statistics paint a picture of growing physician participation in Medicare. A 2014 CMS report shows that a total of 1,226,728 health providers of all specialties participated in Medicare in 2013, up from 1,089,306 in 2012, according to federal data. (The report noted physicians may have been counted in more than one specialty.) There were 219,536 primary care physicians/suppliers who treated Medicare patients in 2013, up from 215,919 in 2012.
But the stats on physician participation do not tell the whole story, said Dr. Austin King, president of the Texas Medical Association and an Abilene otolaryngologist. While many physicians take Medicare patients, he notes that a large portion do not accept new Medicare patients. In Abilene for example, Dr. King said he knows of no internists who accept new Medicare patients. The dilemma means as more of the population reaches Medicare age, there could be fewer doctors to treat them.
“It seems like the government is almost making it more difficult for physicians to treat Medicare patients,” said Dr. King, who limits the number of Medicare patients he treats. “It’s difficult for many reasons, but what I hear most are complaints about the enormous amount of red tape and bureaucracy associated with Medicare.”
For family physician Dr. Andrew Merritt of Marcellus, N.Y., the decision not to accept new Medicare patients made sense 15 years ago and still does today. Medicare is one of the lowest payers in the Marcellus area, he said, second only to Medicaid.
“The trends were there” back in 2000 when he made the decision, he said. “For us, it was fees and regulations, and the regulations have gotten worse.”
The government disputes that more doctors are rejecting new Medicare patients. The percentage of all office-based physicians who report accepting new Medicare patients has not changed significantly between 2005 and 2012, with 87.9% of physicians accepting new Medicare patients in 2005 and 90.7% accepting new patients in 2012, according to a 2013 issue brief from the HHS Office of the Assistant Secretary for Planning and Evaluation. The percentage of doctors accepting new Medicare patients in 2011-2012 is slightly higher than the percentage accepting new private insurance – about 86% of physicians in 2012 accepted new privately insured patients, according to the brief.
“To the extent that there may have been a very small increase in the number of providers ‘opting out,’ that increase has been mitigated by an increase in the share of other physicians who accept new Medicare patients,” according to the issue brief. “Further, the total number of providers participating in and billing Medicare has steadily increased since 2007.”
Dr. Merritt notes while opting out of Medicare might work for some physicians, it’s not practical for all. For instance, in his area, most psychiatrists have opted out of Medicare. “In primary care, it becomes difficult,” he said. “You have to see a lot of people, and it depends on the level of competition.”
Similarly, where a doctor practices impacts Medicare participation, said Dr. Theodore Mazer, a San Diego otolaryngologist and house of delegates speaker at the California Medical Association.
“In my area, Medicare payment is kind of a gold standard,” he said in an interview. “There’s not much that pays better than that. If I can’t pay costs with Medicare, that means I can’t pay costs with any carrier in the area.”
The Association of American Physicians and Surgeons (AAPS) on the other hand, believes with some assessment and planning, most physicians could successfully opt out of Medicare. The AAPS has been hosting a series of workshops and presentations on how to drop Medicare and move to a cash-only practice.
When considering the transition, physicians need to examine their patient base, practice demographics and costs with and without Medicare, said Dr. Lawrence Huntoon, editor-in-chief of the Journal of the Association of American Physicians and Surgeons. He notes a significant amount of professional time and money is often spent on Medicare-related paperwork and administrative burdens.
Dr. Huntoon stopped participating in Medicare in 2004. His practice works with no third-party insurers, including Medicare, and contracts directly with patients for payment.
“I’m very happy with it, and I’ve never regretted it,” he said in an interview. “You just don’t have someone constantly interfering with the care you’re trying to provide.”
On Twitter @legal_med
President unveils details of precision medicine initiative
President Obama seeks to invest $215 million to improve the nation’s ability to explore and leverage precision medicine. He announced details of his plan at a White House event Jan. 30.
The Precision Medicine Initiative, first unveiled at his State of the Union address, will focus on finding the personalized, genetic factors that can lead to cancer and on developing one of the largest patient data sets in the world to study a host of diseases and conditions. The goal of the initiative is to increase physicians’ ability to take a patient’s individual genetic makeup and molecular subtypes of diseases into account to improve the chances of successful treatment.
“Analyzing data from one of the largest research populations ever assembled will teach us more about the connections between us than ever before,” President Obama said during his speech. “This new information will help doctors discover the causes, and one day, the cures, of some of the most deadly diseases that we face.”
The effort will be led by officials at the National Institutes of Health, with the support of other agencies including the Food and Drug Administration and the Office of the National Coordinator for Health Information Technology.
The time is right for this visionary initiative, according to NIH Director Francis S. Collins and National Cancer Institute Director Harold Varmus, who both have key leadership roles.
Oncology is a clear choice for enhancing the near-term impact of precision medicine, they wrote in a perspective published Jan. 30 in the New England Journal of Medicine.
“The cancer-focused component of this initiative will be designed to address some of the obstacles that have already been encountered in precision oncology: unexplained drug resistance, genomic heterogeneity of tumors, insufficient means of monitoring responses and tumor reoccurrence and limited knowledge about the use of drug combinations,” according to the editorial (N. Engl. J. Med. 2015 [doi 10.1056/NEJMp1500523]).
“Precision medicine’s more individualized, molecular approach to cancer will enrich and modify, but not replace the successful staples of oncology – prevention, diagnostics, some screening methods, and effective treatments – while providing a strong framework for accelerating the adoption of precision medicine in other spheres,” Dr. Collins and Dr. Varmus wrote.
The initiative’s plan to generate a giant patient data set will enable the next generation of scientists to develop new ways to detect, measure, and analyze a wide range of biomedical information. The research component will be assembled in part from existing NIH-funded studies that have already been collected or are well positioned to collect data from willing participants.
“Many possibilities for future applications spring to mind,” the authors said of new data set. “Today’s blood counts might be replaced by a census of hundreds of distinct types of immune cells; data from mobile devices might provide real-time monitoring of glucose; blood pressure and cardiac rhythm; genotyping might reveal particular genetic variants that confer protection against specific diseases.”
In unveiling the initiative, President Obama asked for support from patient advocates, researchers, hospitals, and privacy experts. A long-term goal of the initiative is to enable patients to securely access and analyze their own health data, he said.
“Ultimately, this has the possibility to not only help us find new cures, but also help us create a genuine health care system as oppose to just a disease care system,” he said. “Part of what we want to do is allow each of us to have sufficient information about our particular quirks so that we can make better life decisions.”
On Twitter @legal_med
President Obama seeks to invest $215 million to improve the nation’s ability to explore and leverage precision medicine. He announced details of his plan at a White House event Jan. 30.
The Precision Medicine Initiative, first unveiled at his State of the Union address, will focus on finding the personalized, genetic factors that can lead to cancer and on developing one of the largest patient data sets in the world to study a host of diseases and conditions. The goal of the initiative is to increase physicians’ ability to take a patient’s individual genetic makeup and molecular subtypes of diseases into account to improve the chances of successful treatment.
“Analyzing data from one of the largest research populations ever assembled will teach us more about the connections between us than ever before,” President Obama said during his speech. “This new information will help doctors discover the causes, and one day, the cures, of some of the most deadly diseases that we face.”
The effort will be led by officials at the National Institutes of Health, with the support of other agencies including the Food and Drug Administration and the Office of the National Coordinator for Health Information Technology.
The time is right for this visionary initiative, according to NIH Director Francis S. Collins and National Cancer Institute Director Harold Varmus, who both have key leadership roles.
Oncology is a clear choice for enhancing the near-term impact of precision medicine, they wrote in a perspective published Jan. 30 in the New England Journal of Medicine.
“The cancer-focused component of this initiative will be designed to address some of the obstacles that have already been encountered in precision oncology: unexplained drug resistance, genomic heterogeneity of tumors, insufficient means of monitoring responses and tumor reoccurrence and limited knowledge about the use of drug combinations,” according to the editorial (N. Engl. J. Med. 2015 [doi 10.1056/NEJMp1500523]).
“Precision medicine’s more individualized, molecular approach to cancer will enrich and modify, but not replace the successful staples of oncology – prevention, diagnostics, some screening methods, and effective treatments – while providing a strong framework for accelerating the adoption of precision medicine in other spheres,” Dr. Collins and Dr. Varmus wrote.
The initiative’s plan to generate a giant patient data set will enable the next generation of scientists to develop new ways to detect, measure, and analyze a wide range of biomedical information. The research component will be assembled in part from existing NIH-funded studies that have already been collected or are well positioned to collect data from willing participants.
“Many possibilities for future applications spring to mind,” the authors said of new data set. “Today’s blood counts might be replaced by a census of hundreds of distinct types of immune cells; data from mobile devices might provide real-time monitoring of glucose; blood pressure and cardiac rhythm; genotyping might reveal particular genetic variants that confer protection against specific diseases.”
In unveiling the initiative, President Obama asked for support from patient advocates, researchers, hospitals, and privacy experts. A long-term goal of the initiative is to enable patients to securely access and analyze their own health data, he said.
“Ultimately, this has the possibility to not only help us find new cures, but also help us create a genuine health care system as oppose to just a disease care system,” he said. “Part of what we want to do is allow each of us to have sufficient information about our particular quirks so that we can make better life decisions.”
On Twitter @legal_med
President Obama seeks to invest $215 million to improve the nation’s ability to explore and leverage precision medicine. He announced details of his plan at a White House event Jan. 30.
The Precision Medicine Initiative, first unveiled at his State of the Union address, will focus on finding the personalized, genetic factors that can lead to cancer and on developing one of the largest patient data sets in the world to study a host of diseases and conditions. The goal of the initiative is to increase physicians’ ability to take a patient’s individual genetic makeup and molecular subtypes of diseases into account to improve the chances of successful treatment.
“Analyzing data from one of the largest research populations ever assembled will teach us more about the connections between us than ever before,” President Obama said during his speech. “This new information will help doctors discover the causes, and one day, the cures, of some of the most deadly diseases that we face.”
The effort will be led by officials at the National Institutes of Health, with the support of other agencies including the Food and Drug Administration and the Office of the National Coordinator for Health Information Technology.
The time is right for this visionary initiative, according to NIH Director Francis S. Collins and National Cancer Institute Director Harold Varmus, who both have key leadership roles.
Oncology is a clear choice for enhancing the near-term impact of precision medicine, they wrote in a perspective published Jan. 30 in the New England Journal of Medicine.
“The cancer-focused component of this initiative will be designed to address some of the obstacles that have already been encountered in precision oncology: unexplained drug resistance, genomic heterogeneity of tumors, insufficient means of monitoring responses and tumor reoccurrence and limited knowledge about the use of drug combinations,” according to the editorial (N. Engl. J. Med. 2015 [doi 10.1056/NEJMp1500523]).
“Precision medicine’s more individualized, molecular approach to cancer will enrich and modify, but not replace the successful staples of oncology – prevention, diagnostics, some screening methods, and effective treatments – while providing a strong framework for accelerating the adoption of precision medicine in other spheres,” Dr. Collins and Dr. Varmus wrote.
The initiative’s plan to generate a giant patient data set will enable the next generation of scientists to develop new ways to detect, measure, and analyze a wide range of biomedical information. The research component will be assembled in part from existing NIH-funded studies that have already been collected or are well positioned to collect data from willing participants.
“Many possibilities for future applications spring to mind,” the authors said of new data set. “Today’s blood counts might be replaced by a census of hundreds of distinct types of immune cells; data from mobile devices might provide real-time monitoring of glucose; blood pressure and cardiac rhythm; genotyping might reveal particular genetic variants that confer protection against specific diseases.”
In unveiling the initiative, President Obama asked for support from patient advocates, researchers, hospitals, and privacy experts. A long-term goal of the initiative is to enable patients to securely access and analyze their own health data, he said.
“Ultimately, this has the possibility to not only help us find new cures, but also help us create a genuine health care system as oppose to just a disease care system,” he said. “Part of what we want to do is allow each of us to have sufficient information about our particular quirks so that we can make better life decisions.”
On Twitter @legal_med
Poll: Congress should act if subsidies struck down by high court
Most Americans believe Congress should make health insurance subsidies available in all states should the Supreme Court restrict the use of federal tax credits to help purchase coverage.
The findings come from a poll released Jan. 28 by the Kaiser Family Foundation. The results show that few people are paying attention to the pending King v. Burwell, but that nearly two-thirds of patients think Congress should take action if the high court eliminates use of the tax credits. A majority of people in states that use the federal marketplace want their state to create its own marketplace if the Supreme Court limits federal subsidies.
The Supreme Court is set to hear arguments March 4 in the high profile case of King v. Burwell. Justices will weigh whether residents in states that rely on the federal marketplace are eligible for tax credits to purchase insurance, or whether such assistance can only go to residents with state-run marketplaces.
Estimates vary on how many Americans could lose subsidies in 2016 if the high court strikes down the financial assistance. An Urban Institute analysis estimated that just over 6 million people would lose coverage – 61% would be non-Hispanic white, 81% would work full- or part-time, and 82% would have modest incomes, but not be considered poor.
According to a study by the Rand. Corp., individual-market enrollment would decline by an estimated 70%, or 10 million people, if subsidies are eliminated.
As the Supreme Court prepares to hear the case, 34% of adults in states with the federal or partnership marketplaces are aware their state uses the federal marketplace, while 39% believe their state operates its own exchange (28% don’t know), according to the Kaiser Health Tracking Poll. In contrast, most people (63%) in states operating their own exchange are aware that theirs is a state-run marketplace, while about 17% think their state uses the federal marketplace (19% don’t know). More than half of those surveyed said they’ve never heard about the Burwell case.
The Kaiser survey analyzed the responses of 1,503 adults from Jan. 15 through Jan. 21 among a nationally representative random digit dial telephone sample. The combined landline and cell phone sample was weighted to match estimates for the national population using data from the Census Bureau’s 2013 American Community Survey and data from the 2010 Census on population density.
Overall views of the ACA haven’t changed much in the past few months, the survey found. Forty-six percent of people have an unfavorable opinion of the law, while 40% have a favorable opinion. Among uninsured respondents, 60% were unaware that the deadline to enroll in health insurance under the ACA is Feb. 15.
A large number of those surveyed said that they oppose legislation that would change the ACA’s employer coverage threshold for a full-time worker from 30 hours to 40 hours per week: 40% opposed the change while 26% supported it, and 34% said they did not know enough to comment.
On Twitter @legal_med
Most Americans believe Congress should make health insurance subsidies available in all states should the Supreme Court restrict the use of federal tax credits to help purchase coverage.
The findings come from a poll released Jan. 28 by the Kaiser Family Foundation. The results show that few people are paying attention to the pending King v. Burwell, but that nearly two-thirds of patients think Congress should take action if the high court eliminates use of the tax credits. A majority of people in states that use the federal marketplace want their state to create its own marketplace if the Supreme Court limits federal subsidies.
The Supreme Court is set to hear arguments March 4 in the high profile case of King v. Burwell. Justices will weigh whether residents in states that rely on the federal marketplace are eligible for tax credits to purchase insurance, or whether such assistance can only go to residents with state-run marketplaces.
Estimates vary on how many Americans could lose subsidies in 2016 if the high court strikes down the financial assistance. An Urban Institute analysis estimated that just over 6 million people would lose coverage – 61% would be non-Hispanic white, 81% would work full- or part-time, and 82% would have modest incomes, but not be considered poor.
According to a study by the Rand. Corp., individual-market enrollment would decline by an estimated 70%, or 10 million people, if subsidies are eliminated.
As the Supreme Court prepares to hear the case, 34% of adults in states with the federal or partnership marketplaces are aware their state uses the federal marketplace, while 39% believe their state operates its own exchange (28% don’t know), according to the Kaiser Health Tracking Poll. In contrast, most people (63%) in states operating their own exchange are aware that theirs is a state-run marketplace, while about 17% think their state uses the federal marketplace (19% don’t know). More than half of those surveyed said they’ve never heard about the Burwell case.
The Kaiser survey analyzed the responses of 1,503 adults from Jan. 15 through Jan. 21 among a nationally representative random digit dial telephone sample. The combined landline and cell phone sample was weighted to match estimates for the national population using data from the Census Bureau’s 2013 American Community Survey and data from the 2010 Census on population density.
Overall views of the ACA haven’t changed much in the past few months, the survey found. Forty-six percent of people have an unfavorable opinion of the law, while 40% have a favorable opinion. Among uninsured respondents, 60% were unaware that the deadline to enroll in health insurance under the ACA is Feb. 15.
A large number of those surveyed said that they oppose legislation that would change the ACA’s employer coverage threshold for a full-time worker from 30 hours to 40 hours per week: 40% opposed the change while 26% supported it, and 34% said they did not know enough to comment.
On Twitter @legal_med
Most Americans believe Congress should make health insurance subsidies available in all states should the Supreme Court restrict the use of federal tax credits to help purchase coverage.
The findings come from a poll released Jan. 28 by the Kaiser Family Foundation. The results show that few people are paying attention to the pending King v. Burwell, but that nearly two-thirds of patients think Congress should take action if the high court eliminates use of the tax credits. A majority of people in states that use the federal marketplace want their state to create its own marketplace if the Supreme Court limits federal subsidies.
The Supreme Court is set to hear arguments March 4 in the high profile case of King v. Burwell. Justices will weigh whether residents in states that rely on the federal marketplace are eligible for tax credits to purchase insurance, or whether such assistance can only go to residents with state-run marketplaces.
Estimates vary on how many Americans could lose subsidies in 2016 if the high court strikes down the financial assistance. An Urban Institute analysis estimated that just over 6 million people would lose coverage – 61% would be non-Hispanic white, 81% would work full- or part-time, and 82% would have modest incomes, but not be considered poor.
According to a study by the Rand. Corp., individual-market enrollment would decline by an estimated 70%, or 10 million people, if subsidies are eliminated.
As the Supreme Court prepares to hear the case, 34% of adults in states with the federal or partnership marketplaces are aware their state uses the federal marketplace, while 39% believe their state operates its own exchange (28% don’t know), according to the Kaiser Health Tracking Poll. In contrast, most people (63%) in states operating their own exchange are aware that theirs is a state-run marketplace, while about 17% think their state uses the federal marketplace (19% don’t know). More than half of those surveyed said they’ve never heard about the Burwell case.
The Kaiser survey analyzed the responses of 1,503 adults from Jan. 15 through Jan. 21 among a nationally representative random digit dial telephone sample. The combined landline and cell phone sample was weighted to match estimates for the national population using data from the Census Bureau’s 2013 American Community Survey and data from the 2010 Census on population density.
Overall views of the ACA haven’t changed much in the past few months, the survey found. Forty-six percent of people have an unfavorable opinion of the law, while 40% have a favorable opinion. Among uninsured respondents, 60% were unaware that the deadline to enroll in health insurance under the ACA is Feb. 15.
A large number of those surveyed said that they oppose legislation that would change the ACA’s employer coverage threshold for a full-time worker from 30 hours to 40 hours per week: 40% opposed the change while 26% supported it, and 34% said they did not know enough to comment.
On Twitter @legal_med
Court allows generic colchicine to enter market
After a 5-year monopoly on the sale of colchicine put the gout medication out of reach for many patients, a federal judge in January denied an injunction request by Takeda Pharmaceuticals U.S.A. to halt the distribution of colchicine products by Hikma Pharmaceuticals PLC.
The availability of a generic colchicine will introduce competition into the marketplace and drive down costs, said Dr. E. William St.Clair, president of the American College of Rheumatology and chief of the division of rheumatology and immunology at Duke University, Durham, N.C. The ACR issued a friend-of-the-court brief to the federal district court in support of a generic colchicine product entering the market.
“With the steep price increase in colchicine, many patients with gout were now unable to afford chronic colchicine therapy,” Dr. St.Clair said in an interview. “Improving access to colchicine by making it more affordable will increase patient compliance and reduce the suffering and disability associated with repeated gout flares.”
The debate over colchicine and the right to market the medication has a lengthy history. The drug has been prescribed to treat gout for decades, predating the law that requires drugs to be approved by the Food and Drug Administration. In 2009, the FDA approved a brand name colchicine product (Colcrys) by Mutual Pharmaceutical Company/URL Pharmacy Inc. – now Takeda Pharmaceuticals U.S.A. – after the company conducted clinical trials on dosing regimens and performed drug interaction studies. The FDA’s approval of Colcrys came with exclusive marketing rights for gout for 3 years and for familial Mediterranean fever for 7 years.
Mutual Pharmaceutical Company then sued other manufacturers of colchicine, claiming the drug makers were falsely implying that their products were FDA approved. Shortly later, the FDA ordered companies marketing single-ingredient oral colchicine to remove their unapproved products from the market. Physicians and patients meanwhile saw the price of colchicine increase from about 10 cents per tablet to $5 per tablet.
In September 2014, the FDA granted approval for Hikma to market and sell Mitigare, a colchicine capsule for the prophylactic treatment of gout. Hikma had also planned to launch an authorized generic of Mitigare. Before Mitigare could fully launch, Takeda obtained a temporary restraining order against the sale of colchicine products by Hikma, citing Takeda’s patents for acute gout treatment. Takeda simultaneously sued the FDA in a separate proceeding. Takeda said the FDA’s approval of Hikma’s colchicine product was legally impermissible.
In its brief to the federal court, the ACR argued the public interest would be severely disserved by the barring of Hikma’s colchicine product.
“The unfortunate reality is that nearly 30% of patients in the United States take risky and potentially dangerous steps to save money on prescription medicines, with many choosing to skip doses, or not fill their prescriptions altogether,” the ACR said in its brief. “Takeda’s monopoly and the associated price increase for colchicine has resulted in precisely the sorts of risky behavior described.”
A lower court denied Takeda’s preliminary injunction request and the decision was upheld by the U.S. Court of Appeals for the Federal Circuit on Jan. 9. Pending the outcome of further litigation, the federal court ruled that both Takeda and Hikma are free to immediately offer colchicine products for prophylactic use. Also on Jan. 9, the U.S. District Court for the District of Columbia denied Takeda’s request to overturn the FDA’s approval of Mitigare.
In an interview, a Takeda spokeswoman said the company will continue its patent infringement litigation against Hikma and its U.S. subsidiary, West-Ward Pharmaceuticals, along with its lawsuit against the FDA. The company offered no comment on the judge’s decision to deny the injunction.
West-Ward, meanwhile, launched its authorized generic to Mitigare following the judge’s Jan. 9 decision, and Mitigare’s entry to the market was resumed.
“We immediately sought to launch a generic of Mitigare to ensure that adult patients in need of treatment for the prophylaxis of gout flares had access to a lower-cost, alternative colchicine capsule product,” said Spiro Gavaris, vice president of sales and marketing for West-Ward Pharmaceuticals. “We understood that in recent years, some patients may have lost access to, or became frustrated with, colchicine when there was one brand product at a significantly higher price point. With our launch of the authorized generic of Mitigare capsules, doctors can now choose to prescribe Mitigare for the prophylaxis of gout flares in adults, thereby providing these patients with a lower cost generic medication.”
Days after the decision, Takeda announced that it also would be offering access to a generic colchicine. In a statement, the company said it would partner with Prasco Laboratories to distribute Colchicine Tablets, USP, an authorized generic version of Colcrys. The product is being marketed under the Prasco label and became available in U.S. pharmacies in mid-January.
“At Takeda, we remain committed to providing patients with therapies that are safe, efficacious and meet high quality standards,” Douglas Cole, Takeda Pharmaceuticals President, said in a statement. “This new partnership will help enhance patient access to an important gout medicine by supplying Prasco with Colchicine Tablets, USP, manufactured under the same rigorous standards and processes as Colcrys.”
Prices for the Mitigare authorized generic and the Colcrys authorized generic have not been publicly announced. In an interview, West-Ward said it could not comment on exact savings to patients as savings will vary between insurance plans and pharmacy distribution channels.
“Our goal is to provide the most aggressive discounts on generic colchicine in the market with the intent for those discounts to be passed on to adult patients in need of treatment for the prophylaxis of gout flares,” Mr. Gavaris said.
At this article’s deadline, Takeda and Prasco had not responded to a question about the price of the generic Colcrys.
While rheumatologists expressed relief that generic colchicine products have finally become available, they also voiced concerns about potential barriers to access.
“I am proud of what the ACR did here and would hope that it serves as a model for future efforts by professional medical organizations to get into the (often legal) trenches and truly help their patients get affordable care. … [They] put their mouth where the money is and stood up for patients,” said Dr. Christopher M. Burns, a rheumatologist at the Geisel School of Medicine at Dartmouth College, Lebanon, N.H.
“I hope that this will, in fact, reduce the pricing for colchicine, and that it will not allow payers to add an onerous out-of-pocket cost for the drug far in excess of the cost if paid without utilizing pharmacy benefits,” said Dr. Norman B. Gaylis, a rheumatologist in private practice in Aventura, Fla.
Dr. St.Clair added that the future availability and cost of generic colchicine is not certain given common supply-and-demand problems that can arise with generic drugs.
“We have observed critical shortages of several generic medications during the past several years that have drastically affected medical therapy for many common conditions,” he said in an interview. “We will need to keep a close eye on the supply of generic colchicine to ensure it keeps up with the demand. The FDA and the pharmaceutical industry has an obligation to ensure that patients have access to these critical generic drugs.”
On Twitter @legal_med
After a 5-year monopoly on the sale of colchicine put the gout medication out of reach for many patients, a federal judge in January denied an injunction request by Takeda Pharmaceuticals U.S.A. to halt the distribution of colchicine products by Hikma Pharmaceuticals PLC.
The availability of a generic colchicine will introduce competition into the marketplace and drive down costs, said Dr. E. William St.Clair, president of the American College of Rheumatology and chief of the division of rheumatology and immunology at Duke University, Durham, N.C. The ACR issued a friend-of-the-court brief to the federal district court in support of a generic colchicine product entering the market.
“With the steep price increase in colchicine, many patients with gout were now unable to afford chronic colchicine therapy,” Dr. St.Clair said in an interview. “Improving access to colchicine by making it more affordable will increase patient compliance and reduce the suffering and disability associated with repeated gout flares.”
The debate over colchicine and the right to market the medication has a lengthy history. The drug has been prescribed to treat gout for decades, predating the law that requires drugs to be approved by the Food and Drug Administration. In 2009, the FDA approved a brand name colchicine product (Colcrys) by Mutual Pharmaceutical Company/URL Pharmacy Inc. – now Takeda Pharmaceuticals U.S.A. – after the company conducted clinical trials on dosing regimens and performed drug interaction studies. The FDA’s approval of Colcrys came with exclusive marketing rights for gout for 3 years and for familial Mediterranean fever for 7 years.
Mutual Pharmaceutical Company then sued other manufacturers of colchicine, claiming the drug makers were falsely implying that their products were FDA approved. Shortly later, the FDA ordered companies marketing single-ingredient oral colchicine to remove their unapproved products from the market. Physicians and patients meanwhile saw the price of colchicine increase from about 10 cents per tablet to $5 per tablet.
In September 2014, the FDA granted approval for Hikma to market and sell Mitigare, a colchicine capsule for the prophylactic treatment of gout. Hikma had also planned to launch an authorized generic of Mitigare. Before Mitigare could fully launch, Takeda obtained a temporary restraining order against the sale of colchicine products by Hikma, citing Takeda’s patents for acute gout treatment. Takeda simultaneously sued the FDA in a separate proceeding. Takeda said the FDA’s approval of Hikma’s colchicine product was legally impermissible.
In its brief to the federal court, the ACR argued the public interest would be severely disserved by the barring of Hikma’s colchicine product.
“The unfortunate reality is that nearly 30% of patients in the United States take risky and potentially dangerous steps to save money on prescription medicines, with many choosing to skip doses, or not fill their prescriptions altogether,” the ACR said in its brief. “Takeda’s monopoly and the associated price increase for colchicine has resulted in precisely the sorts of risky behavior described.”
A lower court denied Takeda’s preliminary injunction request and the decision was upheld by the U.S. Court of Appeals for the Federal Circuit on Jan. 9. Pending the outcome of further litigation, the federal court ruled that both Takeda and Hikma are free to immediately offer colchicine products for prophylactic use. Also on Jan. 9, the U.S. District Court for the District of Columbia denied Takeda’s request to overturn the FDA’s approval of Mitigare.
In an interview, a Takeda spokeswoman said the company will continue its patent infringement litigation against Hikma and its U.S. subsidiary, West-Ward Pharmaceuticals, along with its lawsuit against the FDA. The company offered no comment on the judge’s decision to deny the injunction.
West-Ward, meanwhile, launched its authorized generic to Mitigare following the judge’s Jan. 9 decision, and Mitigare’s entry to the market was resumed.
“We immediately sought to launch a generic of Mitigare to ensure that adult patients in need of treatment for the prophylaxis of gout flares had access to a lower-cost, alternative colchicine capsule product,” said Spiro Gavaris, vice president of sales and marketing for West-Ward Pharmaceuticals. “We understood that in recent years, some patients may have lost access to, or became frustrated with, colchicine when there was one brand product at a significantly higher price point. With our launch of the authorized generic of Mitigare capsules, doctors can now choose to prescribe Mitigare for the prophylaxis of gout flares in adults, thereby providing these patients with a lower cost generic medication.”
Days after the decision, Takeda announced that it also would be offering access to a generic colchicine. In a statement, the company said it would partner with Prasco Laboratories to distribute Colchicine Tablets, USP, an authorized generic version of Colcrys. The product is being marketed under the Prasco label and became available in U.S. pharmacies in mid-January.
“At Takeda, we remain committed to providing patients with therapies that are safe, efficacious and meet high quality standards,” Douglas Cole, Takeda Pharmaceuticals President, said in a statement. “This new partnership will help enhance patient access to an important gout medicine by supplying Prasco with Colchicine Tablets, USP, manufactured under the same rigorous standards and processes as Colcrys.”
Prices for the Mitigare authorized generic and the Colcrys authorized generic have not been publicly announced. In an interview, West-Ward said it could not comment on exact savings to patients as savings will vary between insurance plans and pharmacy distribution channels.
“Our goal is to provide the most aggressive discounts on generic colchicine in the market with the intent for those discounts to be passed on to adult patients in need of treatment for the prophylaxis of gout flares,” Mr. Gavaris said.
At this article’s deadline, Takeda and Prasco had not responded to a question about the price of the generic Colcrys.
While rheumatologists expressed relief that generic colchicine products have finally become available, they also voiced concerns about potential barriers to access.
“I am proud of what the ACR did here and would hope that it serves as a model for future efforts by professional medical organizations to get into the (often legal) trenches and truly help their patients get affordable care. … [They] put their mouth where the money is and stood up for patients,” said Dr. Christopher M. Burns, a rheumatologist at the Geisel School of Medicine at Dartmouth College, Lebanon, N.H.
“I hope that this will, in fact, reduce the pricing for colchicine, and that it will not allow payers to add an onerous out-of-pocket cost for the drug far in excess of the cost if paid without utilizing pharmacy benefits,” said Dr. Norman B. Gaylis, a rheumatologist in private practice in Aventura, Fla.
Dr. St.Clair added that the future availability and cost of generic colchicine is not certain given common supply-and-demand problems that can arise with generic drugs.
“We have observed critical shortages of several generic medications during the past several years that have drastically affected medical therapy for many common conditions,” he said in an interview. “We will need to keep a close eye on the supply of generic colchicine to ensure it keeps up with the demand. The FDA and the pharmaceutical industry has an obligation to ensure that patients have access to these critical generic drugs.”
On Twitter @legal_med
After a 5-year monopoly on the sale of colchicine put the gout medication out of reach for many patients, a federal judge in January denied an injunction request by Takeda Pharmaceuticals U.S.A. to halt the distribution of colchicine products by Hikma Pharmaceuticals PLC.
The availability of a generic colchicine will introduce competition into the marketplace and drive down costs, said Dr. E. William St.Clair, president of the American College of Rheumatology and chief of the division of rheumatology and immunology at Duke University, Durham, N.C. The ACR issued a friend-of-the-court brief to the federal district court in support of a generic colchicine product entering the market.
“With the steep price increase in colchicine, many patients with gout were now unable to afford chronic colchicine therapy,” Dr. St.Clair said in an interview. “Improving access to colchicine by making it more affordable will increase patient compliance and reduce the suffering and disability associated with repeated gout flares.”
The debate over colchicine and the right to market the medication has a lengthy history. The drug has been prescribed to treat gout for decades, predating the law that requires drugs to be approved by the Food and Drug Administration. In 2009, the FDA approved a brand name colchicine product (Colcrys) by Mutual Pharmaceutical Company/URL Pharmacy Inc. – now Takeda Pharmaceuticals U.S.A. – after the company conducted clinical trials on dosing regimens and performed drug interaction studies. The FDA’s approval of Colcrys came with exclusive marketing rights for gout for 3 years and for familial Mediterranean fever for 7 years.
Mutual Pharmaceutical Company then sued other manufacturers of colchicine, claiming the drug makers were falsely implying that their products were FDA approved. Shortly later, the FDA ordered companies marketing single-ingredient oral colchicine to remove their unapproved products from the market. Physicians and patients meanwhile saw the price of colchicine increase from about 10 cents per tablet to $5 per tablet.
In September 2014, the FDA granted approval for Hikma to market and sell Mitigare, a colchicine capsule for the prophylactic treatment of gout. Hikma had also planned to launch an authorized generic of Mitigare. Before Mitigare could fully launch, Takeda obtained a temporary restraining order against the sale of colchicine products by Hikma, citing Takeda’s patents for acute gout treatment. Takeda simultaneously sued the FDA in a separate proceeding. Takeda said the FDA’s approval of Hikma’s colchicine product was legally impermissible.
In its brief to the federal court, the ACR argued the public interest would be severely disserved by the barring of Hikma’s colchicine product.
“The unfortunate reality is that nearly 30% of patients in the United States take risky and potentially dangerous steps to save money on prescription medicines, with many choosing to skip doses, or not fill their prescriptions altogether,” the ACR said in its brief. “Takeda’s monopoly and the associated price increase for colchicine has resulted in precisely the sorts of risky behavior described.”
A lower court denied Takeda’s preliminary injunction request and the decision was upheld by the U.S. Court of Appeals for the Federal Circuit on Jan. 9. Pending the outcome of further litigation, the federal court ruled that both Takeda and Hikma are free to immediately offer colchicine products for prophylactic use. Also on Jan. 9, the U.S. District Court for the District of Columbia denied Takeda’s request to overturn the FDA’s approval of Mitigare.
In an interview, a Takeda spokeswoman said the company will continue its patent infringement litigation against Hikma and its U.S. subsidiary, West-Ward Pharmaceuticals, along with its lawsuit against the FDA. The company offered no comment on the judge’s decision to deny the injunction.
West-Ward, meanwhile, launched its authorized generic to Mitigare following the judge’s Jan. 9 decision, and Mitigare’s entry to the market was resumed.
“We immediately sought to launch a generic of Mitigare to ensure that adult patients in need of treatment for the prophylaxis of gout flares had access to a lower-cost, alternative colchicine capsule product,” said Spiro Gavaris, vice president of sales and marketing for West-Ward Pharmaceuticals. “We understood that in recent years, some patients may have lost access to, or became frustrated with, colchicine when there was one brand product at a significantly higher price point. With our launch of the authorized generic of Mitigare capsules, doctors can now choose to prescribe Mitigare for the prophylaxis of gout flares in adults, thereby providing these patients with a lower cost generic medication.”
Days after the decision, Takeda announced that it also would be offering access to a generic colchicine. In a statement, the company said it would partner with Prasco Laboratories to distribute Colchicine Tablets, USP, an authorized generic version of Colcrys. The product is being marketed under the Prasco label and became available in U.S. pharmacies in mid-January.
“At Takeda, we remain committed to providing patients with therapies that are safe, efficacious and meet high quality standards,” Douglas Cole, Takeda Pharmaceuticals President, said in a statement. “This new partnership will help enhance patient access to an important gout medicine by supplying Prasco with Colchicine Tablets, USP, manufactured under the same rigorous standards and processes as Colcrys.”
Prices for the Mitigare authorized generic and the Colcrys authorized generic have not been publicly announced. In an interview, West-Ward said it could not comment on exact savings to patients as savings will vary between insurance plans and pharmacy distribution channels.
“Our goal is to provide the most aggressive discounts on generic colchicine in the market with the intent for those discounts to be passed on to adult patients in need of treatment for the prophylaxis of gout flares,” Mr. Gavaris said.
At this article’s deadline, Takeda and Prasco had not responded to a question about the price of the generic Colcrys.
While rheumatologists expressed relief that generic colchicine products have finally become available, they also voiced concerns about potential barriers to access.
“I am proud of what the ACR did here and would hope that it serves as a model for future efforts by professional medical organizations to get into the (often legal) trenches and truly help their patients get affordable care. … [They] put their mouth where the money is and stood up for patients,” said Dr. Christopher M. Burns, a rheumatologist at the Geisel School of Medicine at Dartmouth College, Lebanon, N.H.
“I hope that this will, in fact, reduce the pricing for colchicine, and that it will not allow payers to add an onerous out-of-pocket cost for the drug far in excess of the cost if paid without utilizing pharmacy benefits,” said Dr. Norman B. Gaylis, a rheumatologist in private practice in Aventura, Fla.
Dr. St.Clair added that the future availability and cost of generic colchicine is not certain given common supply-and-demand problems that can arise with generic drugs.
“We have observed critical shortages of several generic medications during the past several years that have drastically affected medical therapy for many common conditions,” he said in an interview. “We will need to keep a close eye on the supply of generic colchicine to ensure it keeps up with the demand. The FDA and the pharmaceutical industry has an obligation to ensure that patients have access to these critical generic drugs.”
On Twitter @legal_med
Robert Califf to lead FDA’s medical products and tobacco
In his new role as deputy commissioner for medical products and tobacco for the Food and Drug Administration, cardiologist Dr. Robert Califf plans to tackle a number of emerging public health and biomedical science issues, including 21st-Century Cures, Big Data, and precision medicine.
“What is especially interesting right now is that there a number of key issues that the FDA needs do deal with,” Dr. Califf said during a press teleconference. “There are so many critical issues where there’s not a single right answer, but there’s a balance that needs to be struck. It’s a great opportunity to help shape these concepts in a broad way.”
The FDA on Jan. 26 announced that Dr. Califf would take on the role of FDA deputy commissioner for medical products, a position that has been vacant since 2013. Dr. Califf is currently vice chancellor of clinical and translational research and professor of medicine in the division of cardiology at Duke University, Durham, N.C. He plans to take a 2-year leave of absence from Duke when he begins his new position in late February.
In his new role, Dr. Califf, a master of the American College of Cardiology, will provide executive leadership to the FDA’s Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Tobacco Products, according to a Jan. 26 announcement by FDA Commissioner Margaret A. Hamburg. Dr. Califf will begin his new role in late February.
“I am delighted to announce this important addition to FDA’s senior leadership team,” Dr. Hamburg said in the statement. “Dr. Califf’s deep knowledge and experience in the areas of medicine and clinical research will enable the agency to capitalize on, and improve upon, the significant advances we’ve made in medical product development and regulation over the last few years.”
As part of his new position, Dr. Califf will also oversee the FDA’s Office of Special Medical Programs and play a critical role in providing high-level advice and policy direction on the agency’s medical product and tobacco priorities, according to the announcement. Additionally, he will manage cross-cutting clinical, scientific, and regulatory initiatives for the agency, including personalized medicine, orphan drugs, pediatric science, and the advisory committee system.
Dr. Califf said he is excited to take on the position during the rapidly changing landscape of health care delivery and scientific advancements. For example, he noted the progress being made in medical data collection and utilization of that information.
“We’re just entering this amazing era of Big Data,” he said during the press conference. “You have multiple dimensions of data on a scale that we’ve never seen before and the question of how to sort out true signal from noise is just a great challenge.”
Dr. Califf acknowledged that he has some learning ahead of him to get up speed on the position, especially when it comes to tobacco.
“As a cardiologist, I’ve only had one theme with tobacco, which is ‘don’t smoke,’ ” he said. “I need a very rapid education about the specifics of tobacco. It’s a very complex issue. I’m not coming in from the outside to tell the center directors what to do. I’m really there to support them.”
Dr. Califf has held multiple roles at Duke, including director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute. He is one of the Top 10 most-cited medical authors with more than 1,200 peer-reviewed publications, according to a Jan. 26 statement released from Duke. He is also an internationally recognized expert in cardiovascular medicine and health outcomes research and played a pivotal role in the development and leadership of the national Patient-Centered Outcomes Research Network. The network is designed to enhance the quality and relevance of clinical evidence used to guide health decisions.
Dr. Califf is currently a member of the Institute of Medicine (IOM) Policy Committee and a liaison to the IOM’s Forum in Drug Discovery, Development, and Translation. He was formally a member of the IOM committees that recommended Medicare coverage of clinical trials and the removal of the dietary supplement ephedra from the market, and a former member of the IOM’s Committee on Identifying and Preventing Medication Errors. In addition, he served on the FDA’s Cardiorenal Advisory Panel and on the Science Board’s Subcommittee on Science and Technology that reviewed the FDA in 2007.
The transition from academia to a regulatory agency will no doubt be challenging, Dr. Califf said. He joked that the hardest part may be not saying what’s on his mind immediately. However, overall, he said he is ready for change.
“Obviously, when you’re on the regulatory side, you have the ultimate responsibility for the public health and not just the well-being of the product you’re interested in,” he said. But “I have spent so much time on all sides of the FDA that I feel pretty comfortable with what the role is going to be.”
Dr. Stephen Spielberg last held the position of FDA deputy commissioner for medical products, serving from 2011 to 2013.
On Twitter @legal_med
In his new role as deputy commissioner for medical products and tobacco for the Food and Drug Administration, cardiologist Dr. Robert Califf plans to tackle a number of emerging public health and biomedical science issues, including 21st-Century Cures, Big Data, and precision medicine.
“What is especially interesting right now is that there a number of key issues that the FDA needs do deal with,” Dr. Califf said during a press teleconference. “There are so many critical issues where there’s not a single right answer, but there’s a balance that needs to be struck. It’s a great opportunity to help shape these concepts in a broad way.”
The FDA on Jan. 26 announced that Dr. Califf would take on the role of FDA deputy commissioner for medical products, a position that has been vacant since 2013. Dr. Califf is currently vice chancellor of clinical and translational research and professor of medicine in the division of cardiology at Duke University, Durham, N.C. He plans to take a 2-year leave of absence from Duke when he begins his new position in late February.
In his new role, Dr. Califf, a master of the American College of Cardiology, will provide executive leadership to the FDA’s Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Tobacco Products, according to a Jan. 26 announcement by FDA Commissioner Margaret A. Hamburg. Dr. Califf will begin his new role in late February.
“I am delighted to announce this important addition to FDA’s senior leadership team,” Dr. Hamburg said in the statement. “Dr. Califf’s deep knowledge and experience in the areas of medicine and clinical research will enable the agency to capitalize on, and improve upon, the significant advances we’ve made in medical product development and regulation over the last few years.”
As part of his new position, Dr. Califf will also oversee the FDA’s Office of Special Medical Programs and play a critical role in providing high-level advice and policy direction on the agency’s medical product and tobacco priorities, according to the announcement. Additionally, he will manage cross-cutting clinical, scientific, and regulatory initiatives for the agency, including personalized medicine, orphan drugs, pediatric science, and the advisory committee system.
Dr. Califf said he is excited to take on the position during the rapidly changing landscape of health care delivery and scientific advancements. For example, he noted the progress being made in medical data collection and utilization of that information.
“We’re just entering this amazing era of Big Data,” he said during the press conference. “You have multiple dimensions of data on a scale that we’ve never seen before and the question of how to sort out true signal from noise is just a great challenge.”
Dr. Califf acknowledged that he has some learning ahead of him to get up speed on the position, especially when it comes to tobacco.
“As a cardiologist, I’ve only had one theme with tobacco, which is ‘don’t smoke,’ ” he said. “I need a very rapid education about the specifics of tobacco. It’s a very complex issue. I’m not coming in from the outside to tell the center directors what to do. I’m really there to support them.”
Dr. Califf has held multiple roles at Duke, including director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute. He is one of the Top 10 most-cited medical authors with more than 1,200 peer-reviewed publications, according to a Jan. 26 statement released from Duke. He is also an internationally recognized expert in cardiovascular medicine and health outcomes research and played a pivotal role in the development and leadership of the national Patient-Centered Outcomes Research Network. The network is designed to enhance the quality and relevance of clinical evidence used to guide health decisions.
Dr. Califf is currently a member of the Institute of Medicine (IOM) Policy Committee and a liaison to the IOM’s Forum in Drug Discovery, Development, and Translation. He was formally a member of the IOM committees that recommended Medicare coverage of clinical trials and the removal of the dietary supplement ephedra from the market, and a former member of the IOM’s Committee on Identifying and Preventing Medication Errors. In addition, he served on the FDA’s Cardiorenal Advisory Panel and on the Science Board’s Subcommittee on Science and Technology that reviewed the FDA in 2007.
The transition from academia to a regulatory agency will no doubt be challenging, Dr. Califf said. He joked that the hardest part may be not saying what’s on his mind immediately. However, overall, he said he is ready for change.
“Obviously, when you’re on the regulatory side, you have the ultimate responsibility for the public health and not just the well-being of the product you’re interested in,” he said. But “I have spent so much time on all sides of the FDA that I feel pretty comfortable with what the role is going to be.”
Dr. Stephen Spielberg last held the position of FDA deputy commissioner for medical products, serving from 2011 to 2013.
On Twitter @legal_med
In his new role as deputy commissioner for medical products and tobacco for the Food and Drug Administration, cardiologist Dr. Robert Califf plans to tackle a number of emerging public health and biomedical science issues, including 21st-Century Cures, Big Data, and precision medicine.
“What is especially interesting right now is that there a number of key issues that the FDA needs do deal with,” Dr. Califf said during a press teleconference. “There are so many critical issues where there’s not a single right answer, but there’s a balance that needs to be struck. It’s a great opportunity to help shape these concepts in a broad way.”
The FDA on Jan. 26 announced that Dr. Califf would take on the role of FDA deputy commissioner for medical products, a position that has been vacant since 2013. Dr. Califf is currently vice chancellor of clinical and translational research and professor of medicine in the division of cardiology at Duke University, Durham, N.C. He plans to take a 2-year leave of absence from Duke when he begins his new position in late February.
In his new role, Dr. Califf, a master of the American College of Cardiology, will provide executive leadership to the FDA’s Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Tobacco Products, according to a Jan. 26 announcement by FDA Commissioner Margaret A. Hamburg. Dr. Califf will begin his new role in late February.
“I am delighted to announce this important addition to FDA’s senior leadership team,” Dr. Hamburg said in the statement. “Dr. Califf’s deep knowledge and experience in the areas of medicine and clinical research will enable the agency to capitalize on, and improve upon, the significant advances we’ve made in medical product development and regulation over the last few years.”
As part of his new position, Dr. Califf will also oversee the FDA’s Office of Special Medical Programs and play a critical role in providing high-level advice and policy direction on the agency’s medical product and tobacco priorities, according to the announcement. Additionally, he will manage cross-cutting clinical, scientific, and regulatory initiatives for the agency, including personalized medicine, orphan drugs, pediatric science, and the advisory committee system.
Dr. Califf said he is excited to take on the position during the rapidly changing landscape of health care delivery and scientific advancements. For example, he noted the progress being made in medical data collection and utilization of that information.
“We’re just entering this amazing era of Big Data,” he said during the press conference. “You have multiple dimensions of data on a scale that we’ve never seen before and the question of how to sort out true signal from noise is just a great challenge.”
Dr. Califf acknowledged that he has some learning ahead of him to get up speed on the position, especially when it comes to tobacco.
“As a cardiologist, I’ve only had one theme with tobacco, which is ‘don’t smoke,’ ” he said. “I need a very rapid education about the specifics of tobacco. It’s a very complex issue. I’m not coming in from the outside to tell the center directors what to do. I’m really there to support them.”
Dr. Califf has held multiple roles at Duke, including director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute. He is one of the Top 10 most-cited medical authors with more than 1,200 peer-reviewed publications, according to a Jan. 26 statement released from Duke. He is also an internationally recognized expert in cardiovascular medicine and health outcomes research and played a pivotal role in the development and leadership of the national Patient-Centered Outcomes Research Network. The network is designed to enhance the quality and relevance of clinical evidence used to guide health decisions.
Dr. Califf is currently a member of the Institute of Medicine (IOM) Policy Committee and a liaison to the IOM’s Forum in Drug Discovery, Development, and Translation. He was formally a member of the IOM committees that recommended Medicare coverage of clinical trials and the removal of the dietary supplement ephedra from the market, and a former member of the IOM’s Committee on Identifying and Preventing Medication Errors. In addition, he served on the FDA’s Cardiorenal Advisory Panel and on the Science Board’s Subcommittee on Science and Technology that reviewed the FDA in 2007.
The transition from academia to a regulatory agency will no doubt be challenging, Dr. Califf said. He joked that the hardest part may be not saying what’s on his mind immediately. However, overall, he said he is ready for change.
“Obviously, when you’re on the regulatory side, you have the ultimate responsibility for the public health and not just the well-being of the product you’re interested in,” he said. But “I have spent so much time on all sides of the FDA that I feel pretty comfortable with what the role is going to be.”
Dr. Stephen Spielberg last held the position of FDA deputy commissioner for medical products, serving from 2011 to 2013.
On Twitter @legal_med
Nine states introduce telemedicine legislation
Legislators in nine states have introduced legislation that would expand the practice of telemedicine by streamlining physician licensure.
Lawmakers in Iowa, Minnesota, Nebraska, Oklahoma, South Dakota, Texas, Utah, Vermont, and Wyoming have proposed bills based on the Interstate Medical Licensure Compact. This model bill was crafted by the Federation of State Medical Boards (FSMB) in an effort to speed the process of issuing licenses for physicians who wish to practice across state lines
The compact offers an effective solution to balancing patient safety and quality care with the needs of a growing and changing health care market, Dr. Humayun J. Chaudhry, president and CEO of FSMB said in a statement. “The growing number of introductions in state legislatures represents the desire for a dynamic system of expedited licensure that simultaneously respects the inherent role of state regulatory agencies in protecting the public,” Dr. Chaudhry said. “At a time when some within the telemedicine industry seek to implement licensing frameworks that undermine and circumvent state licensing rules and practice requirements, the compact is a key element to ensuring state sovereignty while providing the license portability necessary to enhance the delivery of health care.”
The FSMB House of Delegates unanimously approved the development of an interstate compact to expedite medical licensure and facilitate multistate practice at its 2013 annual meeting. Under the proposed system, states and doctors would voluntarily enter into the compact, and approved physicians would be under the jurisdiction of the state medical board in which the patient is located at the time of the medical interaction.
State boards of medicine would retain their individual authority for discipline and oversight, according to the compact. Interested physicians would also need to complete a background check including biometric data (such as fingerprints) and pass all components of either the U.S. Medical Licensing Examination or the Comprehensive Osteopathic Medicine Licensing Examination within three attempts.
More than 25 medical and osteopathic boards have publicly expressed support for the model legislation, according to the FSMB.
On Twitter @legal_med
Legislators in nine states have introduced legislation that would expand the practice of telemedicine by streamlining physician licensure.
Lawmakers in Iowa, Minnesota, Nebraska, Oklahoma, South Dakota, Texas, Utah, Vermont, and Wyoming have proposed bills based on the Interstate Medical Licensure Compact. This model bill was crafted by the Federation of State Medical Boards (FSMB) in an effort to speed the process of issuing licenses for physicians who wish to practice across state lines
The compact offers an effective solution to balancing patient safety and quality care with the needs of a growing and changing health care market, Dr. Humayun J. Chaudhry, president and CEO of FSMB said in a statement. “The growing number of introductions in state legislatures represents the desire for a dynamic system of expedited licensure that simultaneously respects the inherent role of state regulatory agencies in protecting the public,” Dr. Chaudhry said. “At a time when some within the telemedicine industry seek to implement licensing frameworks that undermine and circumvent state licensing rules and practice requirements, the compact is a key element to ensuring state sovereignty while providing the license portability necessary to enhance the delivery of health care.”
The FSMB House of Delegates unanimously approved the development of an interstate compact to expedite medical licensure and facilitate multistate practice at its 2013 annual meeting. Under the proposed system, states and doctors would voluntarily enter into the compact, and approved physicians would be under the jurisdiction of the state medical board in which the patient is located at the time of the medical interaction.
State boards of medicine would retain their individual authority for discipline and oversight, according to the compact. Interested physicians would also need to complete a background check including biometric data (such as fingerprints) and pass all components of either the U.S. Medical Licensing Examination or the Comprehensive Osteopathic Medicine Licensing Examination within three attempts.
More than 25 medical and osteopathic boards have publicly expressed support for the model legislation, according to the FSMB.
On Twitter @legal_med
Legislators in nine states have introduced legislation that would expand the practice of telemedicine by streamlining physician licensure.
Lawmakers in Iowa, Minnesota, Nebraska, Oklahoma, South Dakota, Texas, Utah, Vermont, and Wyoming have proposed bills based on the Interstate Medical Licensure Compact. This model bill was crafted by the Federation of State Medical Boards (FSMB) in an effort to speed the process of issuing licenses for physicians who wish to practice across state lines
The compact offers an effective solution to balancing patient safety and quality care with the needs of a growing and changing health care market, Dr. Humayun J. Chaudhry, president and CEO of FSMB said in a statement. “The growing number of introductions in state legislatures represents the desire for a dynamic system of expedited licensure that simultaneously respects the inherent role of state regulatory agencies in protecting the public,” Dr. Chaudhry said. “At a time when some within the telemedicine industry seek to implement licensing frameworks that undermine and circumvent state licensing rules and practice requirements, the compact is a key element to ensuring state sovereignty while providing the license portability necessary to enhance the delivery of health care.”
The FSMB House of Delegates unanimously approved the development of an interstate compact to expedite medical licensure and facilitate multistate practice at its 2013 annual meeting. Under the proposed system, states and doctors would voluntarily enter into the compact, and approved physicians would be under the jurisdiction of the state medical board in which the patient is located at the time of the medical interaction.
State boards of medicine would retain their individual authority for discipline and oversight, according to the compact. Interested physicians would also need to complete a background check including biometric data (such as fingerprints) and pass all components of either the U.S. Medical Licensing Examination or the Comprehensive Osteopathic Medicine Licensing Examination within three attempts.
More than 25 medical and osteopathic boards have publicly expressed support for the model legislation, according to the FSMB.
On Twitter @legal_med
Attorney: Be Prepared for Next Round of HIPAA Audits
With the next round of HIPAA compliance audits on the horizon, clinicians should ensure they are prepared for both on-site and off-site privacy investigations.
The Office for Civil Rights (OCR) concluded its first pilot of HIPAA audits in 2012 after reviewing the practices and compliance of 115 health care entities. The assessments included health care providers, health plans, and clearing houses. Round two of the audits, originally scheduled for 2014, is expected to begin in early 2015. The next phase will be based on preaudit surveys of 800 covered entities and 400 business associates of covered entities, according to a May announcement in the Federal Register.
The first wave of HIPAA audits revealed weaknesses in the internal controls and compliance programs of many health care entities, particularly small group practices, said Anna C. Watterson, a Washington-based health information privacy and securities attorney and a former OCR policy analyst. Practices of 10-50 providers (Level 4) made up 41% of findings by the OCR and “struggled” with all three focus areas – breach notification, privacy, and security, according to audit results. Findings were generated only for entities that did not meet audit criteria or had potential compliance violations.
“Small providers generally have struggled more with compliance than other organizations,” Ms. Watterson said in an interview. “It’s largely a resource issue. Having a full HIPAA security program is very resource-intensive.”
Understanding the differences between on and off-site audits and what may be required is key to preparing for inquires, said Ms. Watterson, who spoke about HIPAA audits at the American Health Lawyers Association’s health fraud and compliance forum. Off-site audits refer to documentation requests by phone or electronic means. These audits often are limited in scope and pertain to one or two provisions under HIPAA. On-site audits are frequently more intensive and include visits by federal investigators to the provider’s premises.
It is essential to make certain that all compliance and sanction policies are well documented and to reply to requests in a timely manner, Ms. Watterson said. All documentation must be current as of the request date and cannot be created after the inquiry.
Next page: On-site audits >>
During on-site audits, doctors should be prepared to answer questions and have inquires directed at their staff. For example, HIPAA investigators may ask employees about their HIPAA privacy officer, whether they can bring work laptops home and if so, what privacy safeguards are in place.
“Be prepared for OCR to ask employees about actual practices,” Ms. Watterson said. “It’s something organizations want to think about.”
For the first time, phase 2 of the audits will include business associates. Under the omnibus rule, a business associate is defined as any person or entity that creates, receives, maintains, or transmits protected health information (PHI) on behalf of a covered entity. The regulation includes patient safety organizations, data transmission organizations, personal health record vendors, entities that transmit and need routine access to PHI, and data storage vendors – paper based and cloud based.
“OCR will be asking all covered entities for a list of their business associates,” Ms. Watterson said. “Vendor management is something organizations should be [considering]. Have they identified all their vendors? Do they have agreements?”
Business-associate agreements should confirm that associates comply with all measures of the Security Rule for electronic PHI and that business associates report any breach of unsecured PHI.
Having an IT consultant or third-party company perform a security risk analysis is one way to address security weaknesses before an audit, Ms. Watterson said. For doctors in smaller practices with fewer resources, the Office of the National Coordinator for Health Information Technology provides a free, downloadable security risk assessment tool. The National Institute of Standards and Technology also has a free HIPAA Security Rule toolkit for health care organizations.
While preparing for a HIPAA audit may seem daunting, physicians within all practice sizes can plan by reviewing and improving compliance one step at a time, Ms. Watterson stressed. “For a lot of organizations, it’s difficult to set aside the time and resources to just look at all of the compliance. Providers need to prioritize and take a few things that they can tackle” at a time.
With the next round of HIPAA compliance audits on the horizon, clinicians should ensure they are prepared for both on-site and off-site privacy investigations.
The Office for Civil Rights (OCR) concluded its first pilot of HIPAA audits in 2012 after reviewing the practices and compliance of 115 health care entities. The assessments included health care providers, health plans, and clearing houses. Round two of the audits, originally scheduled for 2014, is expected to begin in early 2015. The next phase will be based on preaudit surveys of 800 covered entities and 400 business associates of covered entities, according to a May announcement in the Federal Register.
The first wave of HIPAA audits revealed weaknesses in the internal controls and compliance programs of many health care entities, particularly small group practices, said Anna C. Watterson, a Washington-based health information privacy and securities attorney and a former OCR policy analyst. Practices of 10-50 providers (Level 4) made up 41% of findings by the OCR and “struggled” with all three focus areas – breach notification, privacy, and security, according to audit results. Findings were generated only for entities that did not meet audit criteria or had potential compliance violations.
“Small providers generally have struggled more with compliance than other organizations,” Ms. Watterson said in an interview. “It’s largely a resource issue. Having a full HIPAA security program is very resource-intensive.”
Understanding the differences between on and off-site audits and what may be required is key to preparing for inquires, said Ms. Watterson, who spoke about HIPAA audits at the American Health Lawyers Association’s health fraud and compliance forum. Off-site audits refer to documentation requests by phone or electronic means. These audits often are limited in scope and pertain to one or two provisions under HIPAA. On-site audits are frequently more intensive and include visits by federal investigators to the provider’s premises.
It is essential to make certain that all compliance and sanction policies are well documented and to reply to requests in a timely manner, Ms. Watterson said. All documentation must be current as of the request date and cannot be created after the inquiry.
Next page: On-site audits >>
During on-site audits, doctors should be prepared to answer questions and have inquires directed at their staff. For example, HIPAA investigators may ask employees about their HIPAA privacy officer, whether they can bring work laptops home and if so, what privacy safeguards are in place.
“Be prepared for OCR to ask employees about actual practices,” Ms. Watterson said. “It’s something organizations want to think about.”
For the first time, phase 2 of the audits will include business associates. Under the omnibus rule, a business associate is defined as any person or entity that creates, receives, maintains, or transmits protected health information (PHI) on behalf of a covered entity. The regulation includes patient safety organizations, data transmission organizations, personal health record vendors, entities that transmit and need routine access to PHI, and data storage vendors – paper based and cloud based.
“OCR will be asking all covered entities for a list of their business associates,” Ms. Watterson said. “Vendor management is something organizations should be [considering]. Have they identified all their vendors? Do they have agreements?”
Business-associate agreements should confirm that associates comply with all measures of the Security Rule for electronic PHI and that business associates report any breach of unsecured PHI.
Having an IT consultant or third-party company perform a security risk analysis is one way to address security weaknesses before an audit, Ms. Watterson said. For doctors in smaller practices with fewer resources, the Office of the National Coordinator for Health Information Technology provides a free, downloadable security risk assessment tool. The National Institute of Standards and Technology also has a free HIPAA Security Rule toolkit for health care organizations.
While preparing for a HIPAA audit may seem daunting, physicians within all practice sizes can plan by reviewing and improving compliance one step at a time, Ms. Watterson stressed. “For a lot of organizations, it’s difficult to set aside the time and resources to just look at all of the compliance. Providers need to prioritize and take a few things that they can tackle” at a time.
With the next round of HIPAA compliance audits on the horizon, clinicians should ensure they are prepared for both on-site and off-site privacy investigations.
The Office for Civil Rights (OCR) concluded its first pilot of HIPAA audits in 2012 after reviewing the practices and compliance of 115 health care entities. The assessments included health care providers, health plans, and clearing houses. Round two of the audits, originally scheduled for 2014, is expected to begin in early 2015. The next phase will be based on preaudit surveys of 800 covered entities and 400 business associates of covered entities, according to a May announcement in the Federal Register.
The first wave of HIPAA audits revealed weaknesses in the internal controls and compliance programs of many health care entities, particularly small group practices, said Anna C. Watterson, a Washington-based health information privacy and securities attorney and a former OCR policy analyst. Practices of 10-50 providers (Level 4) made up 41% of findings by the OCR and “struggled” with all three focus areas – breach notification, privacy, and security, according to audit results. Findings were generated only for entities that did not meet audit criteria or had potential compliance violations.
“Small providers generally have struggled more with compliance than other organizations,” Ms. Watterson said in an interview. “It’s largely a resource issue. Having a full HIPAA security program is very resource-intensive.”
Understanding the differences between on and off-site audits and what may be required is key to preparing for inquires, said Ms. Watterson, who spoke about HIPAA audits at the American Health Lawyers Association’s health fraud and compliance forum. Off-site audits refer to documentation requests by phone or electronic means. These audits often are limited in scope and pertain to one or two provisions under HIPAA. On-site audits are frequently more intensive and include visits by federal investigators to the provider’s premises.
It is essential to make certain that all compliance and sanction policies are well documented and to reply to requests in a timely manner, Ms. Watterson said. All documentation must be current as of the request date and cannot be created after the inquiry.
Next page: On-site audits >>
During on-site audits, doctors should be prepared to answer questions and have inquires directed at their staff. For example, HIPAA investigators may ask employees about their HIPAA privacy officer, whether they can bring work laptops home and if so, what privacy safeguards are in place.
“Be prepared for OCR to ask employees about actual practices,” Ms. Watterson said. “It’s something organizations want to think about.”
For the first time, phase 2 of the audits will include business associates. Under the omnibus rule, a business associate is defined as any person or entity that creates, receives, maintains, or transmits protected health information (PHI) on behalf of a covered entity. The regulation includes patient safety organizations, data transmission organizations, personal health record vendors, entities that transmit and need routine access to PHI, and data storage vendors – paper based and cloud based.
“OCR will be asking all covered entities for a list of their business associates,” Ms. Watterson said. “Vendor management is something organizations should be [considering]. Have they identified all their vendors? Do they have agreements?”
Business-associate agreements should confirm that associates comply with all measures of the Security Rule for electronic PHI and that business associates report any breach of unsecured PHI.
Having an IT consultant or third-party company perform a security risk analysis is one way to address security weaknesses before an audit, Ms. Watterson said. For doctors in smaller practices with fewer resources, the Office of the National Coordinator for Health Information Technology provides a free, downloadable security risk assessment tool. The National Institute of Standards and Technology also has a free HIPAA Security Rule toolkit for health care organizations.
While preparing for a HIPAA audit may seem daunting, physicians within all practice sizes can plan by reviewing and improving compliance one step at a time, Ms. Watterson stressed. “For a lot of organizations, it’s difficult to set aside the time and resources to just look at all of the compliance. Providers need to prioritize and take a few things that they can tackle” at a time.