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Heart failure readmission metric not linked to care quality
Metrics used by the Centers for Medicare & Medicaid Services to determine penalties for heart failure hospital readmissions are not associated with quality of care or overall clinical outcomes, according to data presented at the annual scientific sessions of the American Heart Association.
Ambarish Pandey, MD, of the University of Texas Southwestern Medical Center in Dallas, and his colleagues analyzed data from centers participating in the American Heart Association’s Get With The Guidelines-Heart Failure (GWTG-HF) registry linked to Medicare claims from July 2008 to June 2011. Centers were stratified as having low risk-adjusted readmission rates and high risk-adjusted readmission rates based on publicly available data from 2013.
The study included 171 centers with 43,143 patients. Centers were almost evenly split between low- and high-risk–adjusted 30-day readmission rates, with just a few more (51%) falling in the low-risk–adjusted category.
Performance was nearly equal (95.7% for centers with a low risk-adjusted readmission rate vs. 96.5% for those with high risk-adjusted rate) for median adherence to all performance measures, as was the case for median percentage of defect-free care (90.0% vs. 91.1%, respectively) and composite 1-year outcome of death or all-cause readmission rates (median 62.9% vs. 65.3%, respectively). The higher readmission group had higher 1-year all-cause readmission rates (median, 59.1% vs. 54.7%), Dr. Pandey and his colleagues reported in the study that was published simultaneously in JACC: Heart Failure (2016 Nov 15. doi. org/10.1016/j.jchf.2016). One-year mortality rates were lower in the higher readmission group with a trend toward statistical significance (median, 28.2% vs. 31.7%; P = 0.07).
Taken together, the findings suggest the 30-day readmission metrics currently used by CMS to determine readmission penalties are not associated with quality of care or overall clinical outcomes, Dr. Pandey and his colleagues wrote. Results showing higher 30-day readmissions do not necessarily reflect poor quality of care and may be related to other factors.
“These findings question the usefulness of the [hospital readmission reduction program] metric in identifying and penalizing hospitals with low quality of care,” Dr. Pandey wrote, adding that the findings were consistent with previous studies that have demonstrated a lack of association between in-hospital quality of care and 30-day readmission rates.
CMS implemented the federal Hospital Readmissions Reduction Program (HRRP) in 2012 to provide financial incentives for hospitals to reduce readmissions. Under the program, CMS uses claims data to determine whether readmission rates for heart failure, acute myocardial infarction, and pneumonia at eligible hospitals are higher than would be predicted by CMS models. Centers with higher than expected readmission rates face up to a 3% reimbursement penalty.
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These authors add to a chorus of voices expressing concern regarding the appropriateness and validity of the 30-day readmission metric. Arguably, this metric has driven our entire provider workforce to construct machinery designed to reduce short-term posthospitalization utilization, while doing little to improve quality for the 5.7 million (and counting) Americans with heart failure.
Marvin A. Konstam, MD, of Tufts University, Boston, made these comments in an accompanying editorial (JACC: Heart Fail. 2016 Nov 15. doi: 10.1016/j.jchf.2016.10.004). He reported no relevant disclosures.
These authors add to a chorus of voices expressing concern regarding the appropriateness and validity of the 30-day readmission metric. Arguably, this metric has driven our entire provider workforce to construct machinery designed to reduce short-term posthospitalization utilization, while doing little to improve quality for the 5.7 million (and counting) Americans with heart failure.
Marvin A. Konstam, MD, of Tufts University, Boston, made these comments in an accompanying editorial (JACC: Heart Fail. 2016 Nov 15. doi: 10.1016/j.jchf.2016.10.004). He reported no relevant disclosures.
These authors add to a chorus of voices expressing concern regarding the appropriateness and validity of the 30-day readmission metric. Arguably, this metric has driven our entire provider workforce to construct machinery designed to reduce short-term posthospitalization utilization, while doing little to improve quality for the 5.7 million (and counting) Americans with heart failure.
Marvin A. Konstam, MD, of Tufts University, Boston, made these comments in an accompanying editorial (JACC: Heart Fail. 2016 Nov 15. doi: 10.1016/j.jchf.2016.10.004). He reported no relevant disclosures.
Metrics used by the Centers for Medicare & Medicaid Services to determine penalties for heart failure hospital readmissions are not associated with quality of care or overall clinical outcomes, according to data presented at the annual scientific sessions of the American Heart Association.
Ambarish Pandey, MD, of the University of Texas Southwestern Medical Center in Dallas, and his colleagues analyzed data from centers participating in the American Heart Association’s Get With The Guidelines-Heart Failure (GWTG-HF) registry linked to Medicare claims from July 2008 to June 2011. Centers were stratified as having low risk-adjusted readmission rates and high risk-adjusted readmission rates based on publicly available data from 2013.
The study included 171 centers with 43,143 patients. Centers were almost evenly split between low- and high-risk–adjusted 30-day readmission rates, with just a few more (51%) falling in the low-risk–adjusted category.
Performance was nearly equal (95.7% for centers with a low risk-adjusted readmission rate vs. 96.5% for those with high risk-adjusted rate) for median adherence to all performance measures, as was the case for median percentage of defect-free care (90.0% vs. 91.1%, respectively) and composite 1-year outcome of death or all-cause readmission rates (median 62.9% vs. 65.3%, respectively). The higher readmission group had higher 1-year all-cause readmission rates (median, 59.1% vs. 54.7%), Dr. Pandey and his colleagues reported in the study that was published simultaneously in JACC: Heart Failure (2016 Nov 15. doi. org/10.1016/j.jchf.2016). One-year mortality rates were lower in the higher readmission group with a trend toward statistical significance (median, 28.2% vs. 31.7%; P = 0.07).
Taken together, the findings suggest the 30-day readmission metrics currently used by CMS to determine readmission penalties are not associated with quality of care or overall clinical outcomes, Dr. Pandey and his colleagues wrote. Results showing higher 30-day readmissions do not necessarily reflect poor quality of care and may be related to other factors.
“These findings question the usefulness of the [hospital readmission reduction program] metric in identifying and penalizing hospitals with low quality of care,” Dr. Pandey wrote, adding that the findings were consistent with previous studies that have demonstrated a lack of association between in-hospital quality of care and 30-day readmission rates.
CMS implemented the federal Hospital Readmissions Reduction Program (HRRP) in 2012 to provide financial incentives for hospitals to reduce readmissions. Under the program, CMS uses claims data to determine whether readmission rates for heart failure, acute myocardial infarction, and pneumonia at eligible hospitals are higher than would be predicted by CMS models. Centers with higher than expected readmission rates face up to a 3% reimbursement penalty.
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On Twitter @legal_med
Metrics used by the Centers for Medicare & Medicaid Services to determine penalties for heart failure hospital readmissions are not associated with quality of care or overall clinical outcomes, according to data presented at the annual scientific sessions of the American Heart Association.
Ambarish Pandey, MD, of the University of Texas Southwestern Medical Center in Dallas, and his colleagues analyzed data from centers participating in the American Heart Association’s Get With The Guidelines-Heart Failure (GWTG-HF) registry linked to Medicare claims from July 2008 to June 2011. Centers were stratified as having low risk-adjusted readmission rates and high risk-adjusted readmission rates based on publicly available data from 2013.
The study included 171 centers with 43,143 patients. Centers were almost evenly split between low- and high-risk–adjusted 30-day readmission rates, with just a few more (51%) falling in the low-risk–adjusted category.
Performance was nearly equal (95.7% for centers with a low risk-adjusted readmission rate vs. 96.5% for those with high risk-adjusted rate) for median adherence to all performance measures, as was the case for median percentage of defect-free care (90.0% vs. 91.1%, respectively) and composite 1-year outcome of death or all-cause readmission rates (median 62.9% vs. 65.3%, respectively). The higher readmission group had higher 1-year all-cause readmission rates (median, 59.1% vs. 54.7%), Dr. Pandey and his colleagues reported in the study that was published simultaneously in JACC: Heart Failure (2016 Nov 15. doi. org/10.1016/j.jchf.2016). One-year mortality rates were lower in the higher readmission group with a trend toward statistical significance (median, 28.2% vs. 31.7%; P = 0.07).
Taken together, the findings suggest the 30-day readmission metrics currently used by CMS to determine readmission penalties are not associated with quality of care or overall clinical outcomes, Dr. Pandey and his colleagues wrote. Results showing higher 30-day readmissions do not necessarily reflect poor quality of care and may be related to other factors.
“These findings question the usefulness of the [hospital readmission reduction program] metric in identifying and penalizing hospitals with low quality of care,” Dr. Pandey wrote, adding that the findings were consistent with previous studies that have demonstrated a lack of association between in-hospital quality of care and 30-day readmission rates.
CMS implemented the federal Hospital Readmissions Reduction Program (HRRP) in 2012 to provide financial incentives for hospitals to reduce readmissions. Under the program, CMS uses claims data to determine whether readmission rates for heart failure, acute myocardial infarction, and pneumonia at eligible hospitals are higher than would be predicted by CMS models. Centers with higher than expected readmission rates face up to a 3% reimbursement penalty.
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On Twitter @legal_med
FROM THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: Performance was nearly equal (95.7% for centers with a low risk-adjusted readmission rate vs. 96.5% for those with high risk-adjusted rate) for median adherence to all performance measures.
Data source: Analysis of publicly available data reported to the CMS Hospital Readmission Reduction program.
Disclosures: No relevant conflicts of interest.
Doctors have at least seven APM options in 2017
Physicians will have several options to choose from when it comes to advanced alternative payment models (APMs) in 2017.
In an Oct. 25 release, the Centers for Medicare & Medicaid Services announced seven models that will be considered advanced APMs in 2017, including the new Oncology Care Model with two-sided risk. Other advanced APM choices will include:
• Comprehensive Primary Care Plus (CPC+).
• Comprehensive ESRD Care Model (Large Dialysis Organization [LDO] arrangement).
• Comprehensive ESRD Care Model (non-LDO arrangement).
• Medicare Shared Savings Program Accountable Care Organizations (ACOs) – Track 2.
• Medicare Shared Savings Program ACOs – Track 3.
• Next Generation ACO Model.
For the 2017 performance year, CMS estimates that 70,000-120,000 clinicians will participate in an advanced APM. In 2018, more than 125,000 clinicians will likely participate, according to CMS. The agency plans to reopen applications for new practices in the Comprehensive Primary Care Plus (CPC+) model and the Next Generation ACO model for the 2018 performance year.
Other models available for the 2018 performance year will include:
• ACO – Track 1+.
• New voluntary bundled payment model.
• Comprehensive Care for Joint Replacement Payment Model (Certified Electronic Health Record Technology [CEHRT] track).
• Advancing Care Coordination through Episode Payment Models – Track 1 (CEHRT).
For performance years 2017 and 2018, participation requirements will apply only to Medicare payments and physicians who treat Medicare patients. Starting in 2019, clinicians may also meet an alternative standard for advanced APMs that will include non-Medicare payments and patients.
“With these new opportunities, CMS expects that by the 2018 performance period, 25% of clinicians in the Quality Payment Program will earn incentive payments by being a part of these advanced models,” Patrick Conway, MD, CMS deputy administrator said in a statement. “Thanks to MACRA and the Innovation Center, we’re striving to see more Medicare patients benefit from better care when they visit their doctor for a knee replacement, receive cancer treatment, or have a coordinated care team manage their complex conditions.”
CMS is accepting feedback from physicians on the Quality Payment Program final rule until Dec. 17. Doctors can submit their comments and suggestions electronically through the CMS e-Regulation website.
AGA supports physician-focused payment models (PFPMs) tailored to the practice and goals of GIs through the development of episodes of care. We appreciate that CMS has provided flexibility to allow more physicians to be eligible to participate in APMs and are hopeful that there will be new options in the future for gastroenterologists to demonstrate their value and maximize their earnings under APMs.
[email protected]
On Twitter @legal_med
AGA Resource
AGA is committed to preparing you for success in possible new reimbursement environments. Learn more about bundled and episode payment models at http://www.gastro.org/practice-management/quality/bundled-payment-options.
Physicians will have several options to choose from when it comes to advanced alternative payment models (APMs) in 2017.
In an Oct. 25 release, the Centers for Medicare & Medicaid Services announced seven models that will be considered advanced APMs in 2017, including the new Oncology Care Model with two-sided risk. Other advanced APM choices will include:
• Comprehensive Primary Care Plus (CPC+).
• Comprehensive ESRD Care Model (Large Dialysis Organization [LDO] arrangement).
• Comprehensive ESRD Care Model (non-LDO arrangement).
• Medicare Shared Savings Program Accountable Care Organizations (ACOs) – Track 2.
• Medicare Shared Savings Program ACOs – Track 3.
• Next Generation ACO Model.
For the 2017 performance year, CMS estimates that 70,000-120,000 clinicians will participate in an advanced APM. In 2018, more than 125,000 clinicians will likely participate, according to CMS. The agency plans to reopen applications for new practices in the Comprehensive Primary Care Plus (CPC+) model and the Next Generation ACO model for the 2018 performance year.
Other models available for the 2018 performance year will include:
• ACO – Track 1+.
• New voluntary bundled payment model.
• Comprehensive Care for Joint Replacement Payment Model (Certified Electronic Health Record Technology [CEHRT] track).
• Advancing Care Coordination through Episode Payment Models – Track 1 (CEHRT).
For performance years 2017 and 2018, participation requirements will apply only to Medicare payments and physicians who treat Medicare patients. Starting in 2019, clinicians may also meet an alternative standard for advanced APMs that will include non-Medicare payments and patients.
“With these new opportunities, CMS expects that by the 2018 performance period, 25% of clinicians in the Quality Payment Program will earn incentive payments by being a part of these advanced models,” Patrick Conway, MD, CMS deputy administrator said in a statement. “Thanks to MACRA and the Innovation Center, we’re striving to see more Medicare patients benefit from better care when they visit their doctor for a knee replacement, receive cancer treatment, or have a coordinated care team manage their complex conditions.”
CMS is accepting feedback from physicians on the Quality Payment Program final rule until Dec. 17. Doctors can submit their comments and suggestions electronically through the CMS e-Regulation website.
AGA supports physician-focused payment models (PFPMs) tailored to the practice and goals of GIs through the development of episodes of care. We appreciate that CMS has provided flexibility to allow more physicians to be eligible to participate in APMs and are hopeful that there will be new options in the future for gastroenterologists to demonstrate their value and maximize their earnings under APMs.
[email protected]
On Twitter @legal_med
AGA Resource
AGA is committed to preparing you for success in possible new reimbursement environments. Learn more about bundled and episode payment models at http://www.gastro.org/practice-management/quality/bundled-payment-options.
Physicians will have several options to choose from when it comes to advanced alternative payment models (APMs) in 2017.
In an Oct. 25 release, the Centers for Medicare & Medicaid Services announced seven models that will be considered advanced APMs in 2017, including the new Oncology Care Model with two-sided risk. Other advanced APM choices will include:
• Comprehensive Primary Care Plus (CPC+).
• Comprehensive ESRD Care Model (Large Dialysis Organization [LDO] arrangement).
• Comprehensive ESRD Care Model (non-LDO arrangement).
• Medicare Shared Savings Program Accountable Care Organizations (ACOs) – Track 2.
• Medicare Shared Savings Program ACOs – Track 3.
• Next Generation ACO Model.
For the 2017 performance year, CMS estimates that 70,000-120,000 clinicians will participate in an advanced APM. In 2018, more than 125,000 clinicians will likely participate, according to CMS. The agency plans to reopen applications for new practices in the Comprehensive Primary Care Plus (CPC+) model and the Next Generation ACO model for the 2018 performance year.
Other models available for the 2018 performance year will include:
• ACO – Track 1+.
• New voluntary bundled payment model.
• Comprehensive Care for Joint Replacement Payment Model (Certified Electronic Health Record Technology [CEHRT] track).
• Advancing Care Coordination through Episode Payment Models – Track 1 (CEHRT).
For performance years 2017 and 2018, participation requirements will apply only to Medicare payments and physicians who treat Medicare patients. Starting in 2019, clinicians may also meet an alternative standard for advanced APMs that will include non-Medicare payments and patients.
“With these new opportunities, CMS expects that by the 2018 performance period, 25% of clinicians in the Quality Payment Program will earn incentive payments by being a part of these advanced models,” Patrick Conway, MD, CMS deputy administrator said in a statement. “Thanks to MACRA and the Innovation Center, we’re striving to see more Medicare patients benefit from better care when they visit their doctor for a knee replacement, receive cancer treatment, or have a coordinated care team manage their complex conditions.”
CMS is accepting feedback from physicians on the Quality Payment Program final rule until Dec. 17. Doctors can submit their comments and suggestions electronically through the CMS e-Regulation website.
AGA supports physician-focused payment models (PFPMs) tailored to the practice and goals of GIs through the development of episodes of care. We appreciate that CMS has provided flexibility to allow more physicians to be eligible to participate in APMs and are hopeful that there will be new options in the future for gastroenterologists to demonstrate their value and maximize their earnings under APMs.
[email protected]
On Twitter @legal_med
AGA Resource
AGA is committed to preparing you for success in possible new reimbursement environments. Learn more about bundled and episode payment models at http://www.gastro.org/practice-management/quality/bundled-payment-options.
7 tips for successful value-based care contracts
During a recent webinar presented by the American Bar Association, legal experts provided guidance on how doctors can successfully draft pay-for-performance contracts and prevent disputes with payers.
1. Clearly define terms
Contract terms and definitions should be clearly outlined and understood by both parties before value-based agreements are signed, said Melissa J. Hulke, a director in the Berkeley Research Group, LLC health analytics practice.
“Contract terms become central to resolving differences, so it’s important the contract is well defined, especially when moving away from fee for service,” she said. “These are more complex arrangements.”
Another area that needs thorough definition surrounds referral volume. Contracts can include the phrases, “predominately refer” or “primarily refer,” without defining the meaning of “predominately” or “primarily,” Ms. Hulke said.
“If that’s not defined in the contract, it’s hard to establish a benchmark to not only project the provider’s performance under the arrangement and how much revenue they can expect to receive, but it’s hard to know if you’re meeting that benchmark, as well,” she said. “I strongly encourage that if [a term states] “primarily, predominately, [or] mostly refer,” that you have a specific percentage benchmark included. That will help to avoid any disagreement later on.”
2. Review payment calculations
Ensure that payment formulas are examined and agreed upon.
“I think that should be baked into the contracts of today because they are so complex and there is so much money at stake,” she said. “Walk through that compensation exhibit, walk through the examples of what’s supposed to happen.
If not in agreement with calculations, talk to the payer’s financial personnel about how the numbers were reached and try to resolve any differences.
3. Monitor results
Actively monitor projected-to-actual financial performance under the contract. If performance is not being monitored and results are not being tested, it’s impossible to tell whether the contract is succeeding or failing, Ms. Hulke said.
It’s a good idea to monitor projected-to-actual financial performance monthly or at least quarterly, she advised.
“Tracking budget to actual performance and investigating successes and failures are important if the contracts are material to the provider’s business,” Ms. Hulke said.
4. Institute time frames for government methodologies
Be specific about when contracts are linked to Medicare reimbursement methodologies.
If commercial payers are tying payment rates to government programs, which often occurs, contracts should include whether the reimbursement is based on Medicare rates and methodologies as of a particular date and time, according to Ms. Hulke. For instance, the contract could specify that rates are tied to Medicare methodologies at the time the contract was executed. Alternatively, contracts could allow the physician payment rate to fluctuate depending on changes the government makes to Medicare rates and methodologies during the span of the contract.
“If this is not defined, when Medicare makes a change, the parties may have differing opinions on the appropriate rate of reimbursement that’s being paid,” she said.
5. Structure around state and federal laws
Conduct a regulatory analysis before inking any value based payment arrangement/transaction, and structure and document around potential legal constraints, Ms. Hanna said.
Know the laws in your state, she advised. Some states have requirements for provider incentive programs, while others may have rules for provider organizations or intermediaries that assume certain financial risk. When working with federal health care payers, review the Stark Law and Anti-Kickback regulations and ensure that if triggered by the arrangement, the venture falls within an exception of the statutes. Other legal considerations when drafting contracts include:
• HIPAA and state privacy laws.
• Antitrust laws.
• Telemedicine and telehealth laws.
• Medicare Advantage benefit guidelines for programs designed for specific Medicare Advantage populations.
• Scope of practice laws applicable to mid-level medical providers.
6. Design a dispute-resolution strategy
Include a thorough dispute-resolution strategy within the contract. The strategies help facilitate an orderly process for resolving disputes cost effectively, Ms. Hanna said. She suggested that policies start with an informal dispute-resolution process that sends unresolved matters to senior executives at each organization.
“This allows business leaders – and not the lawyers – to find a business solution to a thorny and potentially costly problem before each party gets entrenched in its own position and own sense of having been wronged,” she said in an interview. “The business solution may or may not rely on contract language but may be tailored to keep the relationship moving forward. However, if the informal process proves unsuccessful, then the process gets punted to the legal system – whether in a court proceeding or arbitration.”
7. Have an exit strategy
Include an exit strategy that ensures an end to the arrangement goes as smoothly and fairly as possible. The strategy will depend on the nature and structure of the payer-provider alignment and the value-based payment arrangement, Ms. Hanna said in an interview.
For example, in a true, corporate joint venture, the exit strategy may include buyout rights of the newly formed entity. In this case, it’s important to consider and negotiate the price of the buyout and what circumstances that will trigger the buyout. Termination rights should also be included in an exit strategy, Ms. Hanna said. One option is to allow termination “without case,” by either party.
“Clients often do not like this approach because the intention of the parties going in is to build a strong, long-term relationship where provider and payer benefit,” she said. “A ‘without cause’ termination rights gives the parties a safety valve if circumstances change or the relationship is just not successful.”
An alternative is to allow the relationship time to mature and grow before either party can exercise a without cause termination. A related approach is to develop triggering events that would give one or both parties the right to terminate the agreement, without the other party “having committed a bad act,” Ms. Hanna said in the interview.
“For instance, if the relationship does not meet certain financial or other benchmarks within an agreed-upon time frame, this may be a sufficient reason to terminate the relationship, abandon, or renegotiate the value-based purchasing payment formula or, perhaps, end an exclusive or other preferential relationship,” she said.
[email protected]
On Twitter @legal_med
During a recent webinar presented by the American Bar Association, legal experts provided guidance on how doctors can successfully draft pay-for-performance contracts and prevent disputes with payers.
1. Clearly define terms
Contract terms and definitions should be clearly outlined and understood by both parties before value-based agreements are signed, said Melissa J. Hulke, a director in the Berkeley Research Group, LLC health analytics practice.
“Contract terms become central to resolving differences, so it’s important the contract is well defined, especially when moving away from fee for service,” she said. “These are more complex arrangements.”
Another area that needs thorough definition surrounds referral volume. Contracts can include the phrases, “predominately refer” or “primarily refer,” without defining the meaning of “predominately” or “primarily,” Ms. Hulke said.
“If that’s not defined in the contract, it’s hard to establish a benchmark to not only project the provider’s performance under the arrangement and how much revenue they can expect to receive, but it’s hard to know if you’re meeting that benchmark, as well,” she said. “I strongly encourage that if [a term states] “primarily, predominately, [or] mostly refer,” that you have a specific percentage benchmark included. That will help to avoid any disagreement later on.”
2. Review payment calculations
Ensure that payment formulas are examined and agreed upon.
“I think that should be baked into the contracts of today because they are so complex and there is so much money at stake,” she said. “Walk through that compensation exhibit, walk through the examples of what’s supposed to happen.
If not in agreement with calculations, talk to the payer’s financial personnel about how the numbers were reached and try to resolve any differences.
3. Monitor results
Actively monitor projected-to-actual financial performance under the contract. If performance is not being monitored and results are not being tested, it’s impossible to tell whether the contract is succeeding or failing, Ms. Hulke said.
It’s a good idea to monitor projected-to-actual financial performance monthly or at least quarterly, she advised.
“Tracking budget to actual performance and investigating successes and failures are important if the contracts are material to the provider’s business,” Ms. Hulke said.
4. Institute time frames for government methodologies
Be specific about when contracts are linked to Medicare reimbursement methodologies.
If commercial payers are tying payment rates to government programs, which often occurs, contracts should include whether the reimbursement is based on Medicare rates and methodologies as of a particular date and time, according to Ms. Hulke. For instance, the contract could specify that rates are tied to Medicare methodologies at the time the contract was executed. Alternatively, contracts could allow the physician payment rate to fluctuate depending on changes the government makes to Medicare rates and methodologies during the span of the contract.
“If this is not defined, when Medicare makes a change, the parties may have differing opinions on the appropriate rate of reimbursement that’s being paid,” she said.
5. Structure around state and federal laws
Conduct a regulatory analysis before inking any value based payment arrangement/transaction, and structure and document around potential legal constraints, Ms. Hanna said.
Know the laws in your state, she advised. Some states have requirements for provider incentive programs, while others may have rules for provider organizations or intermediaries that assume certain financial risk. When working with federal health care payers, review the Stark Law and Anti-Kickback regulations and ensure that if triggered by the arrangement, the venture falls within an exception of the statutes. Other legal considerations when drafting contracts include:
• HIPAA and state privacy laws.
• Antitrust laws.
• Telemedicine and telehealth laws.
• Medicare Advantage benefit guidelines for programs designed for specific Medicare Advantage populations.
• Scope of practice laws applicable to mid-level medical providers.
6. Design a dispute-resolution strategy
Include a thorough dispute-resolution strategy within the contract. The strategies help facilitate an orderly process for resolving disputes cost effectively, Ms. Hanna said. She suggested that policies start with an informal dispute-resolution process that sends unresolved matters to senior executives at each organization.
“This allows business leaders – and not the lawyers – to find a business solution to a thorny and potentially costly problem before each party gets entrenched in its own position and own sense of having been wronged,” she said in an interview. “The business solution may or may not rely on contract language but may be tailored to keep the relationship moving forward. However, if the informal process proves unsuccessful, then the process gets punted to the legal system – whether in a court proceeding or arbitration.”
7. Have an exit strategy
Include an exit strategy that ensures an end to the arrangement goes as smoothly and fairly as possible. The strategy will depend on the nature and structure of the payer-provider alignment and the value-based payment arrangement, Ms. Hanna said in an interview.
For example, in a true, corporate joint venture, the exit strategy may include buyout rights of the newly formed entity. In this case, it’s important to consider and negotiate the price of the buyout and what circumstances that will trigger the buyout. Termination rights should also be included in an exit strategy, Ms. Hanna said. One option is to allow termination “without case,” by either party.
“Clients often do not like this approach because the intention of the parties going in is to build a strong, long-term relationship where provider and payer benefit,” she said. “A ‘without cause’ termination rights gives the parties a safety valve if circumstances change or the relationship is just not successful.”
An alternative is to allow the relationship time to mature and grow before either party can exercise a without cause termination. A related approach is to develop triggering events that would give one or both parties the right to terminate the agreement, without the other party “having committed a bad act,” Ms. Hanna said in the interview.
“For instance, if the relationship does not meet certain financial or other benchmarks within an agreed-upon time frame, this may be a sufficient reason to terminate the relationship, abandon, or renegotiate the value-based purchasing payment formula or, perhaps, end an exclusive or other preferential relationship,” she said.
[email protected]
On Twitter @legal_med
During a recent webinar presented by the American Bar Association, legal experts provided guidance on how doctors can successfully draft pay-for-performance contracts and prevent disputes with payers.
1. Clearly define terms
Contract terms and definitions should be clearly outlined and understood by both parties before value-based agreements are signed, said Melissa J. Hulke, a director in the Berkeley Research Group, LLC health analytics practice.
“Contract terms become central to resolving differences, so it’s important the contract is well defined, especially when moving away from fee for service,” she said. “These are more complex arrangements.”
Another area that needs thorough definition surrounds referral volume. Contracts can include the phrases, “predominately refer” or “primarily refer,” without defining the meaning of “predominately” or “primarily,” Ms. Hulke said.
“If that’s not defined in the contract, it’s hard to establish a benchmark to not only project the provider’s performance under the arrangement and how much revenue they can expect to receive, but it’s hard to know if you’re meeting that benchmark, as well,” she said. “I strongly encourage that if [a term states] “primarily, predominately, [or] mostly refer,” that you have a specific percentage benchmark included. That will help to avoid any disagreement later on.”
2. Review payment calculations
Ensure that payment formulas are examined and agreed upon.
“I think that should be baked into the contracts of today because they are so complex and there is so much money at stake,” she said. “Walk through that compensation exhibit, walk through the examples of what’s supposed to happen.
If not in agreement with calculations, talk to the payer’s financial personnel about how the numbers were reached and try to resolve any differences.
3. Monitor results
Actively monitor projected-to-actual financial performance under the contract. If performance is not being monitored and results are not being tested, it’s impossible to tell whether the contract is succeeding or failing, Ms. Hulke said.
It’s a good idea to monitor projected-to-actual financial performance monthly or at least quarterly, she advised.
“Tracking budget to actual performance and investigating successes and failures are important if the contracts are material to the provider’s business,” Ms. Hulke said.
4. Institute time frames for government methodologies
Be specific about when contracts are linked to Medicare reimbursement methodologies.
If commercial payers are tying payment rates to government programs, which often occurs, contracts should include whether the reimbursement is based on Medicare rates and methodologies as of a particular date and time, according to Ms. Hulke. For instance, the contract could specify that rates are tied to Medicare methodologies at the time the contract was executed. Alternatively, contracts could allow the physician payment rate to fluctuate depending on changes the government makes to Medicare rates and methodologies during the span of the contract.
“If this is not defined, when Medicare makes a change, the parties may have differing opinions on the appropriate rate of reimbursement that’s being paid,” she said.
5. Structure around state and federal laws
Conduct a regulatory analysis before inking any value based payment arrangement/transaction, and structure and document around potential legal constraints, Ms. Hanna said.
Know the laws in your state, she advised. Some states have requirements for provider incentive programs, while others may have rules for provider organizations or intermediaries that assume certain financial risk. When working with federal health care payers, review the Stark Law and Anti-Kickback regulations and ensure that if triggered by the arrangement, the venture falls within an exception of the statutes. Other legal considerations when drafting contracts include:
• HIPAA and state privacy laws.
• Antitrust laws.
• Telemedicine and telehealth laws.
• Medicare Advantage benefit guidelines for programs designed for specific Medicare Advantage populations.
• Scope of practice laws applicable to mid-level medical providers.
6. Design a dispute-resolution strategy
Include a thorough dispute-resolution strategy within the contract. The strategies help facilitate an orderly process for resolving disputes cost effectively, Ms. Hanna said. She suggested that policies start with an informal dispute-resolution process that sends unresolved matters to senior executives at each organization.
“This allows business leaders – and not the lawyers – to find a business solution to a thorny and potentially costly problem before each party gets entrenched in its own position and own sense of having been wronged,” she said in an interview. “The business solution may or may not rely on contract language but may be tailored to keep the relationship moving forward. However, if the informal process proves unsuccessful, then the process gets punted to the legal system – whether in a court proceeding or arbitration.”
7. Have an exit strategy
Include an exit strategy that ensures an end to the arrangement goes as smoothly and fairly as possible. The strategy will depend on the nature and structure of the payer-provider alignment and the value-based payment arrangement, Ms. Hanna said in an interview.
For example, in a true, corporate joint venture, the exit strategy may include buyout rights of the newly formed entity. In this case, it’s important to consider and negotiate the price of the buyout and what circumstances that will trigger the buyout. Termination rights should also be included in an exit strategy, Ms. Hanna said. One option is to allow termination “without case,” by either party.
“Clients often do not like this approach because the intention of the parties going in is to build a strong, long-term relationship where provider and payer benefit,” she said. “A ‘without cause’ termination rights gives the parties a safety valve if circumstances change or the relationship is just not successful.”
An alternative is to allow the relationship time to mature and grow before either party can exercise a without cause termination. A related approach is to develop triggering events that would give one or both parties the right to terminate the agreement, without the other party “having committed a bad act,” Ms. Hanna said in the interview.
“For instance, if the relationship does not meet certain financial or other benchmarks within an agreed-upon time frame, this may be a sufficient reason to terminate the relationship, abandon, or renegotiate the value-based purchasing payment formula or, perhaps, end an exclusive or other preferential relationship,” she said.
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On Twitter @legal_med
Doctors have at least seven APM options in 2017
Physicians will have several options to choose from when it comes to advanced alternative payment models (APMs) in 2017.
In an Oct. 25 release, the Centers for Medicare & Medicaid Services announced seven models that will be considered advanced APMs in 2017, including the new Oncology Care Model with two-sided risk. Other advanced APM choices will include:
• Comprehensive Primary Care Plus (CPC+).
• Comprehensive ESRD Care Model (Large Dialysis Organization [LDO] arrangement).
• Comprehensive ESRD Care Model (non-LDO arrangement).
• Medicare Shared Savings Program Accountable Care Organizations (ACOs) – Track 2.
• Medicare Shared Savings Program ACOs – Track 3.
• Next Generation ACO Model.
For the 2017 performance year, CMS estimates that 70,000-120,000 clinicians will participate in an advanced APM. In 2018, more than 125,000 clinicians will likely participate, according to CMS. The agency plans to reopen applications for new practices in the Comprehensive Primary Care Plus (CPC+) model and the Next Generation ACO model for the 2018 performance year.
Other models available for the 2018 performance year will include:
• ACO – Track 1+.
• New voluntary bundled payment model.
• Comprehensive Care for Joint Replacement Payment Model (Certified Electronic Health Record Technology [CEHRT] track).
• Advancing Care Coordination through Episode Payment Models – Track 1 (CEHRT).
For performance years 2017 and 2018, participation requirements will apply only to Medicare payments and physicians who treat Medicare patients. Starting in 2019, clinicians may also meet an alternative standard for advanced APMs that will include non-Medicare payments and patients.
“With these new opportunities, CMS expects that by the 2018 performance period, 25% of clinicians in the Quality Payment Program will earn incentive payments by being a part of these advanced models,” Patrick Conway, MD, CMS deputy administrator said in a statement. “Thanks to MACRA and the Innovation Center, we’re striving to see more Medicare patients benefit from better care when they visit their doctor for a knee replacement, receive cancer treatment, or have a coordinated care team manage their complex conditions.”
CMS is accepting feedback from physicians on the Quality Payment Program final rule until Dec. 17. Doctors can submit their comments and suggestions electronically through the CMS e-Regulation website.
[email protected]
On Twitter @legal_med
Physicians will have several options to choose from when it comes to advanced alternative payment models (APMs) in 2017.
In an Oct. 25 release, the Centers for Medicare & Medicaid Services announced seven models that will be considered advanced APMs in 2017, including the new Oncology Care Model with two-sided risk. Other advanced APM choices will include:
• Comprehensive Primary Care Plus (CPC+).
• Comprehensive ESRD Care Model (Large Dialysis Organization [LDO] arrangement).
• Comprehensive ESRD Care Model (non-LDO arrangement).
• Medicare Shared Savings Program Accountable Care Organizations (ACOs) – Track 2.
• Medicare Shared Savings Program ACOs – Track 3.
• Next Generation ACO Model.
For the 2017 performance year, CMS estimates that 70,000-120,000 clinicians will participate in an advanced APM. In 2018, more than 125,000 clinicians will likely participate, according to CMS. The agency plans to reopen applications for new practices in the Comprehensive Primary Care Plus (CPC+) model and the Next Generation ACO model for the 2018 performance year.
Other models available for the 2018 performance year will include:
• ACO – Track 1+.
• New voluntary bundled payment model.
• Comprehensive Care for Joint Replacement Payment Model (Certified Electronic Health Record Technology [CEHRT] track).
• Advancing Care Coordination through Episode Payment Models – Track 1 (CEHRT).
For performance years 2017 and 2018, participation requirements will apply only to Medicare payments and physicians who treat Medicare patients. Starting in 2019, clinicians may also meet an alternative standard for advanced APMs that will include non-Medicare payments and patients.
“With these new opportunities, CMS expects that by the 2018 performance period, 25% of clinicians in the Quality Payment Program will earn incentive payments by being a part of these advanced models,” Patrick Conway, MD, CMS deputy administrator said in a statement. “Thanks to MACRA and the Innovation Center, we’re striving to see more Medicare patients benefit from better care when they visit their doctor for a knee replacement, receive cancer treatment, or have a coordinated care team manage their complex conditions.”
CMS is accepting feedback from physicians on the Quality Payment Program final rule until Dec. 17. Doctors can submit their comments and suggestions electronically through the CMS e-Regulation website.
[email protected]
On Twitter @legal_med
Physicians will have several options to choose from when it comes to advanced alternative payment models (APMs) in 2017.
In an Oct. 25 release, the Centers for Medicare & Medicaid Services announced seven models that will be considered advanced APMs in 2017, including the new Oncology Care Model with two-sided risk. Other advanced APM choices will include:
• Comprehensive Primary Care Plus (CPC+).
• Comprehensive ESRD Care Model (Large Dialysis Organization [LDO] arrangement).
• Comprehensive ESRD Care Model (non-LDO arrangement).
• Medicare Shared Savings Program Accountable Care Organizations (ACOs) – Track 2.
• Medicare Shared Savings Program ACOs – Track 3.
• Next Generation ACO Model.
For the 2017 performance year, CMS estimates that 70,000-120,000 clinicians will participate in an advanced APM. In 2018, more than 125,000 clinicians will likely participate, according to CMS. The agency plans to reopen applications for new practices in the Comprehensive Primary Care Plus (CPC+) model and the Next Generation ACO model for the 2018 performance year.
Other models available for the 2018 performance year will include:
• ACO – Track 1+.
• New voluntary bundled payment model.
• Comprehensive Care for Joint Replacement Payment Model (Certified Electronic Health Record Technology [CEHRT] track).
• Advancing Care Coordination through Episode Payment Models – Track 1 (CEHRT).
For performance years 2017 and 2018, participation requirements will apply only to Medicare payments and physicians who treat Medicare patients. Starting in 2019, clinicians may also meet an alternative standard for advanced APMs that will include non-Medicare payments and patients.
“With these new opportunities, CMS expects that by the 2018 performance period, 25% of clinicians in the Quality Payment Program will earn incentive payments by being a part of these advanced models,” Patrick Conway, MD, CMS deputy administrator said in a statement. “Thanks to MACRA and the Innovation Center, we’re striving to see more Medicare patients benefit from better care when they visit their doctor for a knee replacement, receive cancer treatment, or have a coordinated care team manage their complex conditions.”
CMS is accepting feedback from physicians on the Quality Payment Program final rule until Dec. 17. Doctors can submit their comments and suggestions electronically through the CMS e-Regulation website.
[email protected]
On Twitter @legal_med
Texas medical board drops appeal against Teladoc
The Texas Medical Board (TMB) has dropped an appeal that had challenged whether national telemedicine company Teladoc could sue over telemedicine restrictions enacted by the board. Both parties will now prepare to argue the merits behind the case in U.S. District Court in Austin, Texas.
TMB plans to vigorously defend its telemedicine rules in court, said Scott Freshour, interim executive director. He did not elaborate on the reasons behind the board’s Oct. 14 vote to withdraw its appeal in the case.
TMB withdrew its appeal because it didn’t want to suffer another loss to Teladoc in the courts, said Adam Vandervoort, Teladoc’s chief legal counsel. In a public meeting, a TMB official called the decision to withdraw “purely strategic,” according to Mr. Vandervoort.
This “raises troubling questions about the TMB’s motives in both filing, and subsequently retracting, the appeal,” Mr. Vandervoort said in a statement. “Teladoc and its amicus parties expended substantial resources on defending the appeal, which now will not result in a decision.”
The dispute stems from a medical board rule that requires Texas physicians to conduct a “face-to-face” evaluation before treating a patient via telemedicine. The face-to-face visit can be conducted through telemedicine at an established medical site, but it may not be established through an online questionnaire, e-mail, text, chat, or telephonic evaluation or consultation. In addition, the TMB requires that distant site providers establish a physician-patient relationship, which at a minimum includes: establishing that the person requesting the treatment is in fact who the person claims to be, establishing a diagnosis through the use of acceptable medical practices, discussing with the patient the risks and benefits of various treatment options, and ensuring the availability of the distant site provider or coverage of the patient for appropriate follow-up care.
Teladoc sued the medical board in April 2015 claiming the face-to-face rule violates federal antitrust laws. Teladoc provides access to medical care via phone or interactive video and treats patients for nonemergency conditions. A judge halted the rule’s enforcement until the litigation is resolved.
The TMB requested that a judge throw out the suit, arguing that the board is immune from antitrust liability as a state agency. A district court disagreed and allowed the case to proceed. The board then appealed to 5th U.S. Circuit Court of Appeals to overturn the district court’s decision.
It’s likely that the board’s decision not to pursue the appeal was affected by the recent backing of Teladoc by the U.S. Department of Justice (DOJ) and the Federal Trade Commission (FTC) regarding the application of the state action doctrine, said Paul W. Pitts, a San Francisco health law attorney who has closely followed the case. The doctrine protects the deliberate policy choices of sovereign states to displace competition with regulation or monopoly public service.
In a brief to the 5th Circuit, the DOJ and the FTC urged the appeals court to dismiss the board’s appeal. The agencies called TMB’s telemedicine rules anticompetitive and said the board was not protected by the state action doctrine because requirements under the doctrine were not satisfied. However, the America Medical Association and the Texas Medical Association sided with the TMB, telling the court the entity should be immune from federal antitrust liability.
Aside from the AMA and Texas Medical Association, the Texas board had few allies in the appeals dispute,” Mr. Pitts said in an interview.
“Many interested parties were lining up on the side of Teledoc by filing amici curiae arguing that the 5th Circuit lacked jurisdiction to hear this appeal and that the state action doctrine is not applicable,” he said. “As the market for telemedicine grows rapidly, there is an increasing number of parties with something at stake in this case.”
Now that the appeal has ended, the district court can get back to the primary issue at hand: whether the rule requiring a face-to-face exam can be justified or whether it’s just a means of protecting the traditional physician practice, Mr. Pitts said. The ultimate ruling in the case has broad implications for the practice of telemedicine in Texas and beyond.
“Medical boards in other states are revising their rules to be more accommodating of telemedicine as the use of this approach grows in acceptance around the country.” he said. “The Texas Medical Board is increasingly an outlier in this space. If Teledoc prevails, you can expect to see investors taking another look at the telemedicine space as the Texas market opens up and the role of the state medical board is diminished.”
[email protected]
On Twitter @legal_med
The Texas Medical Board (TMB) has dropped an appeal that had challenged whether national telemedicine company Teladoc could sue over telemedicine restrictions enacted by the board. Both parties will now prepare to argue the merits behind the case in U.S. District Court in Austin, Texas.
TMB plans to vigorously defend its telemedicine rules in court, said Scott Freshour, interim executive director. He did not elaborate on the reasons behind the board’s Oct. 14 vote to withdraw its appeal in the case.
TMB withdrew its appeal because it didn’t want to suffer another loss to Teladoc in the courts, said Adam Vandervoort, Teladoc’s chief legal counsel. In a public meeting, a TMB official called the decision to withdraw “purely strategic,” according to Mr. Vandervoort.
This “raises troubling questions about the TMB’s motives in both filing, and subsequently retracting, the appeal,” Mr. Vandervoort said in a statement. “Teladoc and its amicus parties expended substantial resources on defending the appeal, which now will not result in a decision.”
The dispute stems from a medical board rule that requires Texas physicians to conduct a “face-to-face” evaluation before treating a patient via telemedicine. The face-to-face visit can be conducted through telemedicine at an established medical site, but it may not be established through an online questionnaire, e-mail, text, chat, or telephonic evaluation or consultation. In addition, the TMB requires that distant site providers establish a physician-patient relationship, which at a minimum includes: establishing that the person requesting the treatment is in fact who the person claims to be, establishing a diagnosis through the use of acceptable medical practices, discussing with the patient the risks and benefits of various treatment options, and ensuring the availability of the distant site provider or coverage of the patient for appropriate follow-up care.
Teladoc sued the medical board in April 2015 claiming the face-to-face rule violates federal antitrust laws. Teladoc provides access to medical care via phone or interactive video and treats patients for nonemergency conditions. A judge halted the rule’s enforcement until the litigation is resolved.
The TMB requested that a judge throw out the suit, arguing that the board is immune from antitrust liability as a state agency. A district court disagreed and allowed the case to proceed. The board then appealed to 5th U.S. Circuit Court of Appeals to overturn the district court’s decision.
It’s likely that the board’s decision not to pursue the appeal was affected by the recent backing of Teladoc by the U.S. Department of Justice (DOJ) and the Federal Trade Commission (FTC) regarding the application of the state action doctrine, said Paul W. Pitts, a San Francisco health law attorney who has closely followed the case. The doctrine protects the deliberate policy choices of sovereign states to displace competition with regulation or monopoly public service.
In a brief to the 5th Circuit, the DOJ and the FTC urged the appeals court to dismiss the board’s appeal. The agencies called TMB’s telemedicine rules anticompetitive and said the board was not protected by the state action doctrine because requirements under the doctrine were not satisfied. However, the America Medical Association and the Texas Medical Association sided with the TMB, telling the court the entity should be immune from federal antitrust liability.
Aside from the AMA and Texas Medical Association, the Texas board had few allies in the appeals dispute,” Mr. Pitts said in an interview.
“Many interested parties were lining up on the side of Teledoc by filing amici curiae arguing that the 5th Circuit lacked jurisdiction to hear this appeal and that the state action doctrine is not applicable,” he said. “As the market for telemedicine grows rapidly, there is an increasing number of parties with something at stake in this case.”
Now that the appeal has ended, the district court can get back to the primary issue at hand: whether the rule requiring a face-to-face exam can be justified or whether it’s just a means of protecting the traditional physician practice, Mr. Pitts said. The ultimate ruling in the case has broad implications for the practice of telemedicine in Texas and beyond.
“Medical boards in other states are revising their rules to be more accommodating of telemedicine as the use of this approach grows in acceptance around the country.” he said. “The Texas Medical Board is increasingly an outlier in this space. If Teledoc prevails, you can expect to see investors taking another look at the telemedicine space as the Texas market opens up and the role of the state medical board is diminished.”
[email protected]
On Twitter @legal_med
The Texas Medical Board (TMB) has dropped an appeal that had challenged whether national telemedicine company Teladoc could sue over telemedicine restrictions enacted by the board. Both parties will now prepare to argue the merits behind the case in U.S. District Court in Austin, Texas.
TMB plans to vigorously defend its telemedicine rules in court, said Scott Freshour, interim executive director. He did not elaborate on the reasons behind the board’s Oct. 14 vote to withdraw its appeal in the case.
TMB withdrew its appeal because it didn’t want to suffer another loss to Teladoc in the courts, said Adam Vandervoort, Teladoc’s chief legal counsel. In a public meeting, a TMB official called the decision to withdraw “purely strategic,” according to Mr. Vandervoort.
This “raises troubling questions about the TMB’s motives in both filing, and subsequently retracting, the appeal,” Mr. Vandervoort said in a statement. “Teladoc and its amicus parties expended substantial resources on defending the appeal, which now will not result in a decision.”
The dispute stems from a medical board rule that requires Texas physicians to conduct a “face-to-face” evaluation before treating a patient via telemedicine. The face-to-face visit can be conducted through telemedicine at an established medical site, but it may not be established through an online questionnaire, e-mail, text, chat, or telephonic evaluation or consultation. In addition, the TMB requires that distant site providers establish a physician-patient relationship, which at a minimum includes: establishing that the person requesting the treatment is in fact who the person claims to be, establishing a diagnosis through the use of acceptable medical practices, discussing with the patient the risks and benefits of various treatment options, and ensuring the availability of the distant site provider or coverage of the patient for appropriate follow-up care.
Teladoc sued the medical board in April 2015 claiming the face-to-face rule violates federal antitrust laws. Teladoc provides access to medical care via phone or interactive video and treats patients for nonemergency conditions. A judge halted the rule’s enforcement until the litigation is resolved.
The TMB requested that a judge throw out the suit, arguing that the board is immune from antitrust liability as a state agency. A district court disagreed and allowed the case to proceed. The board then appealed to 5th U.S. Circuit Court of Appeals to overturn the district court’s decision.
It’s likely that the board’s decision not to pursue the appeal was affected by the recent backing of Teladoc by the U.S. Department of Justice (DOJ) and the Federal Trade Commission (FTC) regarding the application of the state action doctrine, said Paul W. Pitts, a San Francisco health law attorney who has closely followed the case. The doctrine protects the deliberate policy choices of sovereign states to displace competition with regulation or monopoly public service.
In a brief to the 5th Circuit, the DOJ and the FTC urged the appeals court to dismiss the board’s appeal. The agencies called TMB’s telemedicine rules anticompetitive and said the board was not protected by the state action doctrine because requirements under the doctrine were not satisfied. However, the America Medical Association and the Texas Medical Association sided with the TMB, telling the court the entity should be immune from federal antitrust liability.
Aside from the AMA and Texas Medical Association, the Texas board had few allies in the appeals dispute,” Mr. Pitts said in an interview.
“Many interested parties were lining up on the side of Teledoc by filing amici curiae arguing that the 5th Circuit lacked jurisdiction to hear this appeal and that the state action doctrine is not applicable,” he said. “As the market for telemedicine grows rapidly, there is an increasing number of parties with something at stake in this case.”
Now that the appeal has ended, the district court can get back to the primary issue at hand: whether the rule requiring a face-to-face exam can be justified or whether it’s just a means of protecting the traditional physician practice, Mr. Pitts said. The ultimate ruling in the case has broad implications for the practice of telemedicine in Texas and beyond.
“Medical boards in other states are revising their rules to be more accommodating of telemedicine as the use of this approach grows in acceptance around the country.” he said. “The Texas Medical Board is increasingly an outlier in this space. If Teledoc prevails, you can expect to see investors taking another look at the telemedicine space as the Texas market opens up and the role of the state medical board is diminished.”
[email protected]
On Twitter @legal_med
Unvaccinated patients rack up billions in preventable costs
Adult patients who avoid vaccines cost the health care system $7 billion in preventable illness in 2015, according to a meta-analysis.
Sachiko Ozawa, PhD., of the University of North Carolina at Chapel Hill and her colleagues estimated the annual economic burden of diseases associated with 10 adult vaccines recommended by the Centers for Disease Control and Prevention that protect against 14 pathogens by looking at studies with U.S. cost data for adult age groups and using cost-of-illness modeling (Health Affairs 2016 Oct. doi:10.1377/hlthaff.2016.0462).
The cost of outpatient care ranged between $108 and $457 per patient, while the cost of medication ranged from $0 per patient for diseases that do not have curative drug treatments to $605 per patients treated for tetanus, investigators found. When it came to inpatient care, costs ranged from $5,770 per patient for those hospitalized for influenza to $15,600 for those hospitalized for invasive meningococcal disease.
Outpatient productivity loss per patient ranged from $29 for patients requiring a single outpatient visit to $154 for patients diagnosed with HPV-related cancers. Inpatient productivity loss per person ranged from $122 for patients with mumps to $580 for patients with tetanus.
The results underscore the need for improved uptake of vaccines among adults and the need for patients to better appreciate the value of vaccines, Dr. Ozawa said in an interview.
“If these individuals were to be vaccinated, than $7 billion in costs would be eliminated every year from the U.S. economy,” she said. “That’s pretty big. That’s the high-level takeaway.”
Dr. Ozawa said that she hopes the study will spur some creative policy solutions to increase vaccine usage, while preserving the autonomy of patients to make more informed choices.
[email protected]
On Twitter @legal_med
Adult patients who avoid vaccines cost the health care system $7 billion in preventable illness in 2015, according to a meta-analysis.
Sachiko Ozawa, PhD., of the University of North Carolina at Chapel Hill and her colleagues estimated the annual economic burden of diseases associated with 10 adult vaccines recommended by the Centers for Disease Control and Prevention that protect against 14 pathogens by looking at studies with U.S. cost data for adult age groups and using cost-of-illness modeling (Health Affairs 2016 Oct. doi:10.1377/hlthaff.2016.0462).
The cost of outpatient care ranged between $108 and $457 per patient, while the cost of medication ranged from $0 per patient for diseases that do not have curative drug treatments to $605 per patients treated for tetanus, investigators found. When it came to inpatient care, costs ranged from $5,770 per patient for those hospitalized for influenza to $15,600 for those hospitalized for invasive meningococcal disease.
Outpatient productivity loss per patient ranged from $29 for patients requiring a single outpatient visit to $154 for patients diagnosed with HPV-related cancers. Inpatient productivity loss per person ranged from $122 for patients with mumps to $580 for patients with tetanus.
The results underscore the need for improved uptake of vaccines among adults and the need for patients to better appreciate the value of vaccines, Dr. Ozawa said in an interview.
“If these individuals were to be vaccinated, than $7 billion in costs would be eliminated every year from the U.S. economy,” she said. “That’s pretty big. That’s the high-level takeaway.”
Dr. Ozawa said that she hopes the study will spur some creative policy solutions to increase vaccine usage, while preserving the autonomy of patients to make more informed choices.
[email protected]
On Twitter @legal_med
Adult patients who avoid vaccines cost the health care system $7 billion in preventable illness in 2015, according to a meta-analysis.
Sachiko Ozawa, PhD., of the University of North Carolina at Chapel Hill and her colleagues estimated the annual economic burden of diseases associated with 10 adult vaccines recommended by the Centers for Disease Control and Prevention that protect against 14 pathogens by looking at studies with U.S. cost data for adult age groups and using cost-of-illness modeling (Health Affairs 2016 Oct. doi:10.1377/hlthaff.2016.0462).
The cost of outpatient care ranged between $108 and $457 per patient, while the cost of medication ranged from $0 per patient for diseases that do not have curative drug treatments to $605 per patients treated for tetanus, investigators found. When it came to inpatient care, costs ranged from $5,770 per patient for those hospitalized for influenza to $15,600 for those hospitalized for invasive meningococcal disease.
Outpatient productivity loss per patient ranged from $29 for patients requiring a single outpatient visit to $154 for patients diagnosed with HPV-related cancers. Inpatient productivity loss per person ranged from $122 for patients with mumps to $580 for patients with tetanus.
The results underscore the need for improved uptake of vaccines among adults and the need for patients to better appreciate the value of vaccines, Dr. Ozawa said in an interview.
“If these individuals were to be vaccinated, than $7 billion in costs would be eliminated every year from the U.S. economy,” she said. “That’s pretty big. That’s the high-level takeaway.”
Dr. Ozawa said that she hopes the study will spur some creative policy solutions to increase vaccine usage, while preserving the autonomy of patients to make more informed choices.
[email protected]
On Twitter @legal_med
CMS pilot aims to reduce physician administrative burdens
Officials at the Centers for Medicare & Medicaid Services are launching a new initiative aimed at reducing administrative burdens for physicians who participate in certain value-based payment models.
Under an 18-month pilot, providers practicing within certain Advanced Alternative Payment Models (Advanced APMs) will be relieved of additional documentation scrutiny under Medicare medical review programs, according to an Oct. 13 CMS announcement. As part of the effort, the agency will direct Medicare Administrative Contractors and Recovery Audit Contractors to consider doctors participating in Advanced APMs as a low-priority for postpayment claim reviews.
“As we implement the Quality Payment Program under [the Medicare Access and CHIP Reauthorization Act of 2015], we cannot do it without making a sustained, long-term commitment to take a holistic view on the demands on the physician and clinician workforce,” Mr. Slavitt said in a statement. “The new initiative will launch a nationwide effort to work with the clinician community to improve Medicare regulations, policies, and interaction points to address issues and to help get physicians back to the most important thing they do – taking care of patients.”
The pilot will have two phases, beginning in early 2017, and will include Advanced APMs, Next Generation Accountable Care Organizations, Medicare Shared Savings Program Track 2 and Track 3 participants, Pioneer Accountable Care Organizations, and Oncology Care Model two-sided track participants.
As part of the program, clinicians will be engaged in regional discussions with CMS regarding documentation requirements and their interactions with the agency. To that end, each of the 10 CMS regional offices will oversee local meetings to gather feedback from physician practices within the next 6 months and conduct regular meetings thereafter. The local meetings will result in a report with targeted recommendations to the CMS Administrator in 2017.
The American Medical Association praised the effort to reduce regulatory burdens.
The American College of Physicians also applauded the initiative, but said the initiative should be expanded to include other advanced APMs, such as the Comprehensive Primary Care Plus program, Nitin S. Damle, MD, the college’s president, said in a statement.
“It is critical to us that this initiative be conducted in addition to – not in lieu of – other needed reforms to reduce burdensome administrative tasks and simplify MACRA implementation,” Dr. Damle said.
[email protected]
On Twitter @legal_med
Officials at the Centers for Medicare & Medicaid Services are launching a new initiative aimed at reducing administrative burdens for physicians who participate in certain value-based payment models.
Under an 18-month pilot, providers practicing within certain Advanced Alternative Payment Models (Advanced APMs) will be relieved of additional documentation scrutiny under Medicare medical review programs, according to an Oct. 13 CMS announcement. As part of the effort, the agency will direct Medicare Administrative Contractors and Recovery Audit Contractors to consider doctors participating in Advanced APMs as a low-priority for postpayment claim reviews.
“As we implement the Quality Payment Program under [the Medicare Access and CHIP Reauthorization Act of 2015], we cannot do it without making a sustained, long-term commitment to take a holistic view on the demands on the physician and clinician workforce,” Mr. Slavitt said in a statement. “The new initiative will launch a nationwide effort to work with the clinician community to improve Medicare regulations, policies, and interaction points to address issues and to help get physicians back to the most important thing they do – taking care of patients.”
The pilot will have two phases, beginning in early 2017, and will include Advanced APMs, Next Generation Accountable Care Organizations, Medicare Shared Savings Program Track 2 and Track 3 participants, Pioneer Accountable Care Organizations, and Oncology Care Model two-sided track participants.
As part of the program, clinicians will be engaged in regional discussions with CMS regarding documentation requirements and their interactions with the agency. To that end, each of the 10 CMS regional offices will oversee local meetings to gather feedback from physician practices within the next 6 months and conduct regular meetings thereafter. The local meetings will result in a report with targeted recommendations to the CMS Administrator in 2017.
The American Medical Association praised the effort to reduce regulatory burdens.
The American College of Physicians also applauded the initiative, but said the initiative should be expanded to include other advanced APMs, such as the Comprehensive Primary Care Plus program, Nitin S. Damle, MD, the college’s president, said in a statement.
“It is critical to us that this initiative be conducted in addition to – not in lieu of – other needed reforms to reduce burdensome administrative tasks and simplify MACRA implementation,” Dr. Damle said.
[email protected]
On Twitter @legal_med
Officials at the Centers for Medicare & Medicaid Services are launching a new initiative aimed at reducing administrative burdens for physicians who participate in certain value-based payment models.
Under an 18-month pilot, providers practicing within certain Advanced Alternative Payment Models (Advanced APMs) will be relieved of additional documentation scrutiny under Medicare medical review programs, according to an Oct. 13 CMS announcement. As part of the effort, the agency will direct Medicare Administrative Contractors and Recovery Audit Contractors to consider doctors participating in Advanced APMs as a low-priority for postpayment claim reviews.
“As we implement the Quality Payment Program under [the Medicare Access and CHIP Reauthorization Act of 2015], we cannot do it without making a sustained, long-term commitment to take a holistic view on the demands on the physician and clinician workforce,” Mr. Slavitt said in a statement. “The new initiative will launch a nationwide effort to work with the clinician community to improve Medicare regulations, policies, and interaction points to address issues and to help get physicians back to the most important thing they do – taking care of patients.”
The pilot will have two phases, beginning in early 2017, and will include Advanced APMs, Next Generation Accountable Care Organizations, Medicare Shared Savings Program Track 2 and Track 3 participants, Pioneer Accountable Care Organizations, and Oncology Care Model two-sided track participants.
As part of the program, clinicians will be engaged in regional discussions with CMS regarding documentation requirements and their interactions with the agency. To that end, each of the 10 CMS regional offices will oversee local meetings to gather feedback from physician practices within the next 6 months and conduct regular meetings thereafter. The local meetings will result in a report with targeted recommendations to the CMS Administrator in 2017.
The American Medical Association praised the effort to reduce regulatory burdens.
The American College of Physicians also applauded the initiative, but said the initiative should be expanded to include other advanced APMs, such as the Comprehensive Primary Care Plus program, Nitin S. Damle, MD, the college’s president, said in a statement.
“It is critical to us that this initiative be conducted in addition to – not in lieu of – other needed reforms to reduce burdensome administrative tasks and simplify MACRA implementation,” Dr. Damle said.
[email protected]
On Twitter @legal_med
Almost half of health providers will see PQRS pay cut
About half of all doctors who participate in the Physician Quality Reporting System (PQRS) soon will learn that their Medicare pay will be cut by up to 2% in 2017.
The Centers for Medicare & Medicaid Services has completed its assessments for reporting year 2015 and has begun notifying physicians that a 2.0% negative payment adjustment is forthcoming for those who did not satisfactorily report PQRS quality measures or who failed to satisfactorily participate in a qualified clinical data registry.
Doctors have just 2 months to challenge findings that they believe were made in error to spare themselves the 2017 cut, according to a CMS announcement.
If doctors believe their 2017 PQRS pay cut is erroneous, they can submit an informal review request by 11:59 p.m. EST on Nov. 30. CMS will investigate the merits of all review requests and issue a decision within 90 days. All requests for informal review must be submitted via a Web-based tool on the quality reporting communication support page. There are no hardship exemptions for the PQRS pay cuts.
In addition, some 2015 PQRS performance scores will be publicly reported on the Physician Compare website. CMS is hosting two sessions in October to provide further information about such public reporting.
In 2015, approximately 1.15 million professionals were eligible and able to participate in PQRS; just over half (624,077 or 54%) of eligible professionals successfully submitted data. The rest – about 528,000, or 46% – will see a pay cut in 2017, according to CMS.
Last year, slightly more health providers – 558,885 eligible professionals – were subject to the 2016 PQRS pay cut based on their 2014 reporting experience.
Walter J. Gorski, director of regulatory affairs for the American College of Physicians, said the college will be monitoring the notifications as they go out to physicians to assess impacts at the individual practice level and overall.
“In past years, the PQRS experience reports have shown a low level of participation in the program and, thus, a large number of physicians being subject to these negative adjustments,” Mr. Gorski said in an interview. “This low level of overall participation has long been a concern of ours and something we have recommended that CMS work to mitigate by simplifying reporting – something that we are pushing strongly for as the program is rolled into the new MIPS pathway [Merit-Based Incentive Payment System] within the [Quality Payment Program].”
The new Quality Payment Program will replace both PQRS and the Value Modifier program, as well as the separate payment adjustments under the Medicare EHR Incentive Program. The streamlined program will have reduced quality reporting requirements and a flexible design that allows eligible clinicians to pick the pace of participation during the first year, according to CMS.
“The newly announced ‘pick your pace’ approach for the first year of MIPS reporting will give physicians an opportunity to get their feet wet with quality reporting in a way that will protect them from future negative adjustments,” Mr. Gorski said.
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On Twitter @legal_med
About half of all doctors who participate in the Physician Quality Reporting System (PQRS) soon will learn that their Medicare pay will be cut by up to 2% in 2017.
The Centers for Medicare & Medicaid Services has completed its assessments for reporting year 2015 and has begun notifying physicians that a 2.0% negative payment adjustment is forthcoming for those who did not satisfactorily report PQRS quality measures or who failed to satisfactorily participate in a qualified clinical data registry.
Doctors have just 2 months to challenge findings that they believe were made in error to spare themselves the 2017 cut, according to a CMS announcement.
If doctors believe their 2017 PQRS pay cut is erroneous, they can submit an informal review request by 11:59 p.m. EST on Nov. 30. CMS will investigate the merits of all review requests and issue a decision within 90 days. All requests for informal review must be submitted via a Web-based tool on the quality reporting communication support page. There are no hardship exemptions for the PQRS pay cuts.
In addition, some 2015 PQRS performance scores will be publicly reported on the Physician Compare website. CMS is hosting two sessions in October to provide further information about such public reporting.
In 2015, approximately 1.15 million professionals were eligible and able to participate in PQRS; just over half (624,077 or 54%) of eligible professionals successfully submitted data. The rest – about 528,000, or 46% – will see a pay cut in 2017, according to CMS.
Last year, slightly more health providers – 558,885 eligible professionals – were subject to the 2016 PQRS pay cut based on their 2014 reporting experience.
Walter J. Gorski, director of regulatory affairs for the American College of Physicians, said the college will be monitoring the notifications as they go out to physicians to assess impacts at the individual practice level and overall.
“In past years, the PQRS experience reports have shown a low level of participation in the program and, thus, a large number of physicians being subject to these negative adjustments,” Mr. Gorski said in an interview. “This low level of overall participation has long been a concern of ours and something we have recommended that CMS work to mitigate by simplifying reporting – something that we are pushing strongly for as the program is rolled into the new MIPS pathway [Merit-Based Incentive Payment System] within the [Quality Payment Program].”
The new Quality Payment Program will replace both PQRS and the Value Modifier program, as well as the separate payment adjustments under the Medicare EHR Incentive Program. The streamlined program will have reduced quality reporting requirements and a flexible design that allows eligible clinicians to pick the pace of participation during the first year, according to CMS.
“The newly announced ‘pick your pace’ approach for the first year of MIPS reporting will give physicians an opportunity to get their feet wet with quality reporting in a way that will protect them from future negative adjustments,” Mr. Gorski said.
[email protected]
On Twitter @legal_med
About half of all doctors who participate in the Physician Quality Reporting System (PQRS) soon will learn that their Medicare pay will be cut by up to 2% in 2017.
The Centers for Medicare & Medicaid Services has completed its assessments for reporting year 2015 and has begun notifying physicians that a 2.0% negative payment adjustment is forthcoming for those who did not satisfactorily report PQRS quality measures or who failed to satisfactorily participate in a qualified clinical data registry.
Doctors have just 2 months to challenge findings that they believe were made in error to spare themselves the 2017 cut, according to a CMS announcement.
If doctors believe their 2017 PQRS pay cut is erroneous, they can submit an informal review request by 11:59 p.m. EST on Nov. 30. CMS will investigate the merits of all review requests and issue a decision within 90 days. All requests for informal review must be submitted via a Web-based tool on the quality reporting communication support page. There are no hardship exemptions for the PQRS pay cuts.
In addition, some 2015 PQRS performance scores will be publicly reported on the Physician Compare website. CMS is hosting two sessions in October to provide further information about such public reporting.
In 2015, approximately 1.15 million professionals were eligible and able to participate in PQRS; just over half (624,077 or 54%) of eligible professionals successfully submitted data. The rest – about 528,000, or 46% – will see a pay cut in 2017, according to CMS.
Last year, slightly more health providers – 558,885 eligible professionals – were subject to the 2016 PQRS pay cut based on their 2014 reporting experience.
Walter J. Gorski, director of regulatory affairs for the American College of Physicians, said the college will be monitoring the notifications as they go out to physicians to assess impacts at the individual practice level and overall.
“In past years, the PQRS experience reports have shown a low level of participation in the program and, thus, a large number of physicians being subject to these negative adjustments,” Mr. Gorski said in an interview. “This low level of overall participation has long been a concern of ours and something we have recommended that CMS work to mitigate by simplifying reporting – something that we are pushing strongly for as the program is rolled into the new MIPS pathway [Merit-Based Incentive Payment System] within the [Quality Payment Program].”
The new Quality Payment Program will replace both PQRS and the Value Modifier program, as well as the separate payment adjustments under the Medicare EHR Incentive Program. The streamlined program will have reduced quality reporting requirements and a flexible design that allows eligible clinicians to pick the pace of participation during the first year, according to CMS.
“The newly announced ‘pick your pace’ approach for the first year of MIPS reporting will give physicians an opportunity to get their feet wet with quality reporting in a way that will protect them from future negative adjustments,” Mr. Gorski said.
[email protected]
On Twitter @legal_med
Diagnostic error most common claim against internists
The majority of lawsuits against internists stem from alleged diagnostics errors, results of a new study show.
Of 1,180 legal claims against internists, 39% were related to failed, delayed, or wrong diagnosis allegations, according to an analysis published by The Doctors Company, a nationwide medical malpractice insurer. Negligence associated with medical treatment accounted for 32% of the claims, while 19% were related to alleged medication errors.
The Doctors Company evaluated 1,180 claims from its database against internal medicine physicians that closed from 2007 to 2014. Of diagnostic-related cases, 56% alleged inadequate patient assessments, such as failure to order or delay in ordering diagnostic tests. The final diagnoses most commonly related to these allegations were myocardial infarction (6%), lung cancer (5%), and colorectal cancer (5%). More than 200 other diagnoses were seen in fewer than 2% of the claims, according to the study.
In cases that involved injury, a top contributing factor was patient assessment issues, such as failure to establish a differential diagnosis or inadequate assessment. Patient factors, such as noncompliance, were also a primary contributer to injuries. The third most common factor for injury was poor communication among providers, family, and patients, such as inadequate education about the risks of medications.
The findings hopefully will assist internists and risk managers in understanding common allegations and factors behind lawsuits so that improvements can be made, study coauthor David B. Troxel, MD, medical director for The Doctors Company said in a statement.
“With the data on patient allegations and the actual factors that led to injuries included in this study, physicians and risk managers can identify system weaknesses and reduce risk of harm to patients,” he said.
“Physicians, internists, would benefit from something we’re doing in my group where we talk about why it is that there are cognitive errors,” he said. “Is there a system problem here, rather than someone who just made a mistake?”
Dr. Marcus advised physicians to read a recent report by the National Academies of Sciences, Engineering, and Medicine, which calls for more emphasis on identifying and learning from diagnostic errors and near misses in clinical practice, a payment and care delivery environment that supports the diagnostic process, and a dedicated focus on new research.
Ensuring that patients understand the treatment plan and follow-up care management are also key risk mitigation steps, adds Dr. Troxel.
“Patient compliance is a major problem,” he said in an interview. “It’s not that patients are not listening to the doctor. Sometimes they don’t understand what the doctor is explaining. We encourage physicians to really make sure the patient understands by asking them to repeat back what you’ve told them. Make sure they got the information.”
[email protected]
On Twitter @legal_med
The majority of lawsuits against internists stem from alleged diagnostics errors, results of a new study show.
Of 1,180 legal claims against internists, 39% were related to failed, delayed, or wrong diagnosis allegations, according to an analysis published by The Doctors Company, a nationwide medical malpractice insurer. Negligence associated with medical treatment accounted for 32% of the claims, while 19% were related to alleged medication errors.
The Doctors Company evaluated 1,180 claims from its database against internal medicine physicians that closed from 2007 to 2014. Of diagnostic-related cases, 56% alleged inadequate patient assessments, such as failure to order or delay in ordering diagnostic tests. The final diagnoses most commonly related to these allegations were myocardial infarction (6%), lung cancer (5%), and colorectal cancer (5%). More than 200 other diagnoses were seen in fewer than 2% of the claims, according to the study.
In cases that involved injury, a top contributing factor was patient assessment issues, such as failure to establish a differential diagnosis or inadequate assessment. Patient factors, such as noncompliance, were also a primary contributer to injuries. The third most common factor for injury was poor communication among providers, family, and patients, such as inadequate education about the risks of medications.
The findings hopefully will assist internists and risk managers in understanding common allegations and factors behind lawsuits so that improvements can be made, study coauthor David B. Troxel, MD, medical director for The Doctors Company said in a statement.
“With the data on patient allegations and the actual factors that led to injuries included in this study, physicians and risk managers can identify system weaknesses and reduce risk of harm to patients,” he said.
“Physicians, internists, would benefit from something we’re doing in my group where we talk about why it is that there are cognitive errors,” he said. “Is there a system problem here, rather than someone who just made a mistake?”
Dr. Marcus advised physicians to read a recent report by the National Academies of Sciences, Engineering, and Medicine, which calls for more emphasis on identifying and learning from diagnostic errors and near misses in clinical practice, a payment and care delivery environment that supports the diagnostic process, and a dedicated focus on new research.
Ensuring that patients understand the treatment plan and follow-up care management are also key risk mitigation steps, adds Dr. Troxel.
“Patient compliance is a major problem,” he said in an interview. “It’s not that patients are not listening to the doctor. Sometimes they don’t understand what the doctor is explaining. We encourage physicians to really make sure the patient understands by asking them to repeat back what you’ve told them. Make sure they got the information.”
[email protected]
On Twitter @legal_med
The majority of lawsuits against internists stem from alleged diagnostics errors, results of a new study show.
Of 1,180 legal claims against internists, 39% were related to failed, delayed, or wrong diagnosis allegations, according to an analysis published by The Doctors Company, a nationwide medical malpractice insurer. Negligence associated with medical treatment accounted for 32% of the claims, while 19% were related to alleged medication errors.
The Doctors Company evaluated 1,180 claims from its database against internal medicine physicians that closed from 2007 to 2014. Of diagnostic-related cases, 56% alleged inadequate patient assessments, such as failure to order or delay in ordering diagnostic tests. The final diagnoses most commonly related to these allegations were myocardial infarction (6%), lung cancer (5%), and colorectal cancer (5%). More than 200 other diagnoses were seen in fewer than 2% of the claims, according to the study.
In cases that involved injury, a top contributing factor was patient assessment issues, such as failure to establish a differential diagnosis or inadequate assessment. Patient factors, such as noncompliance, were also a primary contributer to injuries. The third most common factor for injury was poor communication among providers, family, and patients, such as inadequate education about the risks of medications.
The findings hopefully will assist internists and risk managers in understanding common allegations and factors behind lawsuits so that improvements can be made, study coauthor David B. Troxel, MD, medical director for The Doctors Company said in a statement.
“With the data on patient allegations and the actual factors that led to injuries included in this study, physicians and risk managers can identify system weaknesses and reduce risk of harm to patients,” he said.
“Physicians, internists, would benefit from something we’re doing in my group where we talk about why it is that there are cognitive errors,” he said. “Is there a system problem here, rather than someone who just made a mistake?”
Dr. Marcus advised physicians to read a recent report by the National Academies of Sciences, Engineering, and Medicine, which calls for more emphasis on identifying and learning from diagnostic errors and near misses in clinical practice, a payment and care delivery environment that supports the diagnostic process, and a dedicated focus on new research.
Ensuring that patients understand the treatment plan and follow-up care management are also key risk mitigation steps, adds Dr. Troxel.
“Patient compliance is a major problem,” he said in an interview. “It’s not that patients are not listening to the doctor. Sometimes they don’t understand what the doctor is explaining. We encourage physicians to really make sure the patient understands by asking them to repeat back what you’ve told them. Make sure they got the information.”
[email protected]
On Twitter @legal_med
Zika funding slated for prevention, vaccine development
Federal health officials are wasting no time in putting to use long-awaited congressional funding aimed at strengthening Zika prevention and advancing research efforts.
The country’s health care agencies will split the $1.1 billion in funding approved by Congress on Sept. 28, dividing the money among Zika vaccine development, mosquito control, and response to virus outbreaks in the United States and globally, Sylvia Burwell, Health and Human Services secretary, said during an Oct. 3 press conference.
“At HHS, we’ll put this funding to use quickly and wisely,” Secretary Burwell said during the press conference. “It will support essential strategies to combat this virus, like expanding mosquito surveillance and control programs. It will also help us further accelerate the development of tests to detect Zika treatment and vaccines, including beginning human testing of additional vaccine candidates. It will also fund vital research as we continue to learn about the virus and monitor the progress of babies born with Zika-related birth defects.”
Of the $1.1 billion included in the final package to fight Zika, $15 million will go to the state of Florida and $60 million to the territory of Puerto Rico to respond to Zika outbreaks in those areas.
The Centers for Disease Control and Prevention will receive $394 million, of which $44 million will go toward replenishing funds pulled from the Public Health Emergency Preparedness (PHEP) cooperative agreement to address the Zika crisis, said CDC Director Tom Frieden, MD. The CDC’s remaining $350 million will allow the agency to extend existing responses to Zika outbreaks and grow partnerships with state and local authorities.
The National Institutes of Health will use its portion of the Zika funding – $152 million – to further vaccine development and move forward clinical trials already in the works, said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases. The NIH is well on its way with a phase I vaccine trial, having enrolled 80 patients thus far, Dr. Fauci said during the press call. The agency will soon have enough information to determine to move onto phase II, he said.
Meanwhile, HHS will use its portion of the funding – $245 million – to support advanced vaccine development and ensure the drug manufacturing process runs smoothly and quickly, said Nicole Lurie, MD, HHS assistant secretary for preparedness and response. Agency officials also plan to support more clinical trials that will be integrated with the ongoing NIH trials, she said.
The remaining funds from the bill will go toward global health programs, operating costs, and other expenses.
Despite the positives from the supplemental funding, Secretary Burwell noted that Congress’ delay in approving the extra money has caused irreparable harm to other health care programs and initiatives. HHS diverted funds from other departments, such as the Administration for Children and Families and the Substance Abuse and Mental Health Services Administration to address Zika outbreaks and begin research. Vaccine and diagnostic developments are also behind because of funding delays, according to officials.
“The damage that occurred because we took those funds will continue,” Secretary Burwell said. “The time and energy that was spent in seeking and working to get the funding instead of working to use the funding [was detrimental]. That money would be out the door if we were in a situation where we had received that money at the point at which we had asked for it.”
[email protected]
On Twitter @legal_med
Federal health officials are wasting no time in putting to use long-awaited congressional funding aimed at strengthening Zika prevention and advancing research efforts.
The country’s health care agencies will split the $1.1 billion in funding approved by Congress on Sept. 28, dividing the money among Zika vaccine development, mosquito control, and response to virus outbreaks in the United States and globally, Sylvia Burwell, Health and Human Services secretary, said during an Oct. 3 press conference.
“At HHS, we’ll put this funding to use quickly and wisely,” Secretary Burwell said during the press conference. “It will support essential strategies to combat this virus, like expanding mosquito surveillance and control programs. It will also help us further accelerate the development of tests to detect Zika treatment and vaccines, including beginning human testing of additional vaccine candidates. It will also fund vital research as we continue to learn about the virus and monitor the progress of babies born with Zika-related birth defects.”
Of the $1.1 billion included in the final package to fight Zika, $15 million will go to the state of Florida and $60 million to the territory of Puerto Rico to respond to Zika outbreaks in those areas.
The Centers for Disease Control and Prevention will receive $394 million, of which $44 million will go toward replenishing funds pulled from the Public Health Emergency Preparedness (PHEP) cooperative agreement to address the Zika crisis, said CDC Director Tom Frieden, MD. The CDC’s remaining $350 million will allow the agency to extend existing responses to Zika outbreaks and grow partnerships with state and local authorities.
The National Institutes of Health will use its portion of the Zika funding – $152 million – to further vaccine development and move forward clinical trials already in the works, said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases. The NIH is well on its way with a phase I vaccine trial, having enrolled 80 patients thus far, Dr. Fauci said during the press call. The agency will soon have enough information to determine to move onto phase II, he said.
Meanwhile, HHS will use its portion of the funding – $245 million – to support advanced vaccine development and ensure the drug manufacturing process runs smoothly and quickly, said Nicole Lurie, MD, HHS assistant secretary for preparedness and response. Agency officials also plan to support more clinical trials that will be integrated with the ongoing NIH trials, she said.
The remaining funds from the bill will go toward global health programs, operating costs, and other expenses.
Despite the positives from the supplemental funding, Secretary Burwell noted that Congress’ delay in approving the extra money has caused irreparable harm to other health care programs and initiatives. HHS diverted funds from other departments, such as the Administration for Children and Families and the Substance Abuse and Mental Health Services Administration to address Zika outbreaks and begin research. Vaccine and diagnostic developments are also behind because of funding delays, according to officials.
“The damage that occurred because we took those funds will continue,” Secretary Burwell said. “The time and energy that was spent in seeking and working to get the funding instead of working to use the funding [was detrimental]. That money would be out the door if we were in a situation where we had received that money at the point at which we had asked for it.”
[email protected]
On Twitter @legal_med
Federal health officials are wasting no time in putting to use long-awaited congressional funding aimed at strengthening Zika prevention and advancing research efforts.
The country’s health care agencies will split the $1.1 billion in funding approved by Congress on Sept. 28, dividing the money among Zika vaccine development, mosquito control, and response to virus outbreaks in the United States and globally, Sylvia Burwell, Health and Human Services secretary, said during an Oct. 3 press conference.
“At HHS, we’ll put this funding to use quickly and wisely,” Secretary Burwell said during the press conference. “It will support essential strategies to combat this virus, like expanding mosquito surveillance and control programs. It will also help us further accelerate the development of tests to detect Zika treatment and vaccines, including beginning human testing of additional vaccine candidates. It will also fund vital research as we continue to learn about the virus and monitor the progress of babies born with Zika-related birth defects.”
Of the $1.1 billion included in the final package to fight Zika, $15 million will go to the state of Florida and $60 million to the territory of Puerto Rico to respond to Zika outbreaks in those areas.
The Centers for Disease Control and Prevention will receive $394 million, of which $44 million will go toward replenishing funds pulled from the Public Health Emergency Preparedness (PHEP) cooperative agreement to address the Zika crisis, said CDC Director Tom Frieden, MD. The CDC’s remaining $350 million will allow the agency to extend existing responses to Zika outbreaks and grow partnerships with state and local authorities.
The National Institutes of Health will use its portion of the Zika funding – $152 million – to further vaccine development and move forward clinical trials already in the works, said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases. The NIH is well on its way with a phase I vaccine trial, having enrolled 80 patients thus far, Dr. Fauci said during the press call. The agency will soon have enough information to determine to move onto phase II, he said.
Meanwhile, HHS will use its portion of the funding – $245 million – to support advanced vaccine development and ensure the drug manufacturing process runs smoothly and quickly, said Nicole Lurie, MD, HHS assistant secretary for preparedness and response. Agency officials also plan to support more clinical trials that will be integrated with the ongoing NIH trials, she said.
The remaining funds from the bill will go toward global health programs, operating costs, and other expenses.
Despite the positives from the supplemental funding, Secretary Burwell noted that Congress’ delay in approving the extra money has caused irreparable harm to other health care programs and initiatives. HHS diverted funds from other departments, such as the Administration for Children and Families and the Substance Abuse and Mental Health Services Administration to address Zika outbreaks and begin research. Vaccine and diagnostic developments are also behind because of funding delays, according to officials.
“The damage that occurred because we took those funds will continue,” Secretary Burwell said. “The time and energy that was spent in seeking and working to get the funding instead of working to use the funding [was detrimental]. That money would be out the door if we were in a situation where we had received that money at the point at which we had asked for it.”
[email protected]
On Twitter @legal_med