Phil Porte

Under current Medicare law and regulations, the Center for Medicare and Medicaid Services (CMS) has a confusing mix of rules that is complicated to understand and certainly contrary to the current standards of practice. Earlier this year, NAMDRC, CHEST, and about a dozen other societies wrote to CMS citing problems:

• Medicare does not recognize FDA classifications of devices as ventilators. Therefore, while one agency within the Department of Health & Human Services is specifically charged with the responsibility for determining safety and efficacy of medical devices and providing strict rules for labeling, a sister agency in the same department is not bound to accept those determinations. This has the effect of CMS stating that “just because FDA calls a device a ventilator does not make it a ventilator.”

This bizarre scenario is undoubtedly tied to a current statute that requires CMS to pay for certain ventilators under the “frequent and substantial servicing” payment methodology rather than the “capped rental” payment methodology. If CMS believes it might pay too much for home mechanical ventilators, it simply says that the worrisome device is actually a “respiratory assist device,” a term it has created for payment purposes.

• In 2001, CMS issued a Decision Memo that has the effect of signaling that in order to receive home mechanical ventilation, there must be the presence of an artificial airway AND removal of the device would lead to death. This principle is fraught with problems from various perspectives. First, even though the memo explicitly states “contractor discretion,” the key Medicare contractors have repeatedly signaled they have no flexibility and must adhere to that principle.

Secondly, with the advent of noninvasive mechanical ventilation, CMS created codes for processing such devices through the payment system, even though the 2001 Decision Memo refers to the need for an artificial airway. The inconsistency in these policies have led to confusion from ordering physicians and suppliers as well.

• Now, in 2015, the state-of-the-art of home mechanical ventilation is a world apart from 2001, and no policies have been updated related to home mechanical ventilation. Respiratory assist devices (RADs) or bilevel devices to everyone except Medicare recipients, are part of the problem. Because access to RADs are covered by very strict, inflexible Medicare rules, physicians and suppliers often find it easier to prescribe a ventilator for treatment of respiratory failure.

Possible solutions: Crafting solutions might seem relatively easy, but we want to ensure that rules we might agree to today need to be flexible enough to address innovations 2, 3, or 5 years from now. Therefore, the pathway of a national coverage determination (NCD) might not be the best approach because once an NCD is set into policy, it is a challenging effort to modify it, even if CMS agrees that problems with the relatively new policy need adjustment. Therefore, NAMDRC is working with other societies to craft some important principles and shape those principles into new policies that CMS could adopt outside of the NCD framework. Those principles include the following:

• A specific definition of “respiratory failure” that can be used to guide physicians, suppliers, and payers. Under this principle, if a diagnosis of respiratory failure meets the clinical definition and the physician certifies the medical necessity of treating respiratory failure, part of the treatment plan, by definition, includes a home mechanical ventilator.

• We see little need to distinguish between invasive and noninvasive home mechanical ventilation for coverage purposes. The principle outlined in the 2001 Decision Memo is outdated and no one genuinely believes that, by definition, the most critically ill must have a trach in order to survive. Let the physician determine the best approach; and in the case of many patients, particularly in the neuromuscular arena, a patient might use invasive mechanical ventilation nocturnally and noninvasive ventilation at other times. Importantly, most devices today can accommodate either approach.

• CMS’s RAD policy should be reshaped to provide greater flexibility to ensure that bilevel devices are available to those patients where less intensive therapy is appropriate.

We are hopeful that a revamped set of policies could be in place by the end of the year or early in 2016.

Under current Medicare law and regulations, the Center for Medicare and Medicaid Services (CMS) has a confusing mix of rules that is complicated to understand and certainly contrary to the current standards of practice. Earlier this year, NAMDRC, CHEST, and about a dozen other societies wrote to CMS citing problems:

• Medicare does not recognize FDA classifications of devices as ventilators. Therefore, while one agency within the Department of Health & Human Services is specifically charged with the responsibility for determining safety and efficacy of medical devices and providing strict rules for labeling, a sister agency in the same department is not bound to accept those determinations. This has the effect of CMS stating that “just because FDA calls a device a ventilator does not make it a ventilator.”

This bizarre scenario is undoubtedly tied to a current statute that requires CMS to pay for certain ventilators under the “frequent and substantial servicing” payment methodology rather than the “capped rental” payment methodology. If CMS believes it might pay too much for home mechanical ventilators, it simply says that the worrisome device is actually a “respiratory assist device,” a term it has created for payment purposes.

• In 2001, CMS issued a Decision Memo that has the effect of signaling that in order to receive home mechanical ventilation, there must be the presence of an artificial airway AND removal of the device would lead to death. This principle is fraught with problems from various perspectives. First, even though the memo explicitly states “contractor discretion,” the key Medicare contractors have repeatedly signaled they have no flexibility and must adhere to that principle.

Secondly, with the advent of noninvasive mechanical ventilation, CMS created codes for processing such devices through the payment system, even though the 2001 Decision Memo refers to the need for an artificial airway. The inconsistency in these policies have led to confusion from ordering physicians and suppliers as well.

• Now, in 2015, the state-of-the-art of home mechanical ventilation is a world apart from 2001, and no policies have been updated related to home mechanical ventilation. Respiratory assist devices (RADs) or bilevel devices to everyone except Medicare recipients, are part of the problem. Because access to RADs are covered by very strict, inflexible Medicare rules, physicians and suppliers often find it easier to prescribe a ventilator for treatment of respiratory failure.

Possible solutions: Crafting solutions might seem relatively easy, but we want to ensure that rules we might agree to today need to be flexible enough to address innovations 2, 3, or 5 years from now. Therefore, the pathway of a national coverage determination (NCD) might not be the best approach because once an NCD is set into policy, it is a challenging effort to modify it, even if CMS agrees that problems with the relatively new policy need adjustment. Therefore, NAMDRC is working with other societies to craft some important principles and shape those principles into new policies that CMS could adopt outside of the NCD framework. Those principles include the following:

• A specific definition of “respiratory failure” that can be used to guide physicians, suppliers, and payers. Under this principle, if a diagnosis of respiratory failure meets the clinical definition and the physician certifies the medical necessity of treating respiratory failure, part of the treatment plan, by definition, includes a home mechanical ventilator.

• We see little need to distinguish between invasive and noninvasive home mechanical ventilation for coverage purposes. The principle outlined in the 2001 Decision Memo is outdated and no one genuinely believes that, by definition, the most critically ill must have a trach in order to survive. Let the physician determine the best approach; and in the case of many patients, particularly in the neuromuscular arena, a patient might use invasive mechanical ventilation nocturnally and noninvasive ventilation at other times. Importantly, most devices today can accommodate either approach.

• CMS’s RAD policy should be reshaped to provide greater flexibility to ensure that bilevel devices are available to those patients where less intensive therapy is appropriate.

We are hopeful that a revamped set of policies could be in place by the end of the year or early in 2016.

Under current Medicare law and regulations, the Center for Medicare and Medicaid Services (CMS) has a confusing mix of rules that is complicated to understand and certainly contrary to the current standards of practice. Earlier this year, NAMDRC, CHEST, and about a dozen other societies wrote to CMS citing problems:

• Medicare does not recognize FDA classifications of devices as ventilators. Therefore, while one agency within the Department of Health & Human Services is specifically charged with the responsibility for determining safety and efficacy of medical devices and providing strict rules for labeling, a sister agency in the same department is not bound to accept those determinations. This has the effect of CMS stating that “just because FDA calls a device a ventilator does not make it a ventilator.”

This bizarre scenario is undoubtedly tied to a current statute that requires CMS to pay for certain ventilators under the “frequent and substantial servicing” payment methodology rather than the “capped rental” payment methodology. If CMS believes it might pay too much for home mechanical ventilators, it simply says that the worrisome device is actually a “respiratory assist device,” a term it has created for payment purposes.

• In 2001, CMS issued a Decision Memo that has the effect of signaling that in order to receive home mechanical ventilation, there must be the presence of an artificial airway AND removal of the device would lead to death. This principle is fraught with problems from various perspectives. First, even though the memo explicitly states “contractor discretion,” the key Medicare contractors have repeatedly signaled they have no flexibility and must adhere to that principle.

Secondly, with the advent of noninvasive mechanical ventilation, CMS created codes for processing such devices through the payment system, even though the 2001 Decision Memo refers to the need for an artificial airway. The inconsistency in these policies have led to confusion from ordering physicians and suppliers as well.

• Now, in 2015, the state-of-the-art of home mechanical ventilation is a world apart from 2001, and no policies have been updated related to home mechanical ventilation. Respiratory assist devices (RADs) or bilevel devices to everyone except Medicare recipients, are part of the problem. Because access to RADs are covered by very strict, inflexible Medicare rules, physicians and suppliers often find it easier to prescribe a ventilator for treatment of respiratory failure.

Possible solutions: Crafting solutions might seem relatively easy, but we want to ensure that rules we might agree to today need to be flexible enough to address innovations 2, 3, or 5 years from now. Therefore, the pathway of a national coverage determination (NCD) might not be the best approach because once an NCD is set into policy, it is a challenging effort to modify it, even if CMS agrees that problems with the relatively new policy need adjustment. Therefore, NAMDRC is working with other societies to craft some important principles and shape those principles into new policies that CMS could adopt outside of the NCD framework. Those principles include the following:

• A specific definition of “respiratory failure” that can be used to guide physicians, suppliers, and payers. Under this principle, if a diagnosis of respiratory failure meets the clinical definition and the physician certifies the medical necessity of treating respiratory failure, part of the treatment plan, by definition, includes a home mechanical ventilator.

• We see little need to distinguish between invasive and noninvasive home mechanical ventilation for coverage purposes. The principle outlined in the 2001 Decision Memo is outdated and no one genuinely believes that, by definition, the most critically ill must have a trach in order to survive. Let the physician determine the best approach; and in the case of many patients, particularly in the neuromuscular arena, a patient might use invasive mechanical ventilation nocturnally and noninvasive ventilation at other times. Importantly, most devices today can accommodate either approach.

• CMS’s RAD policy should be reshaped to provide greater flexibility to ensure that bilevel devices are available to those patients where less intensive therapy is appropriate.

We are hopeful that a revamped set of policies could be in place by the end of the year or early in 2016.

NAMDRC is bringing together representatives of key medical societies, including CHEST, ATS, AARC, SCCM, AACN, SHM (hospitalists), PPAHS (patient safety), and ACEP (emergency physicians) to address respiratory compromise, that cascade of events that moves from respiratory insufficiency to respiratory failure to respiratory arrest. Recognizing that respiratory compromise occurs in various settings, the conference, Feb 26-27 in Orlando, Florida, will focus on the hospital setting.

In addition to society representatives, the NAMDRC leadership, in consultation with recognized experts, has also invited several key opinion leaders to participate, including physicians, respiratory therapists, and nurses.

There are several challenges facing the participants, perhaps paramount is to define the concept of “respiratory compromise.” Some of have signaled, “I know it when I see it,” but the expectation is to formulate a specific clinical definition of the respiratory deterioration, and devise a recognition pathway that can easily be used in the hospital setting to identify patients earlier in the course of this cascade.

How to identify high risk patients is critical to the discussion, because it is generally believed that this is where resources need to be focused, both from a personnel and monitoring perspective. Can consensus be drawn to determine which patient characteristics can reliably classify that patient into a high risk for respiratory compromise, and, if so, those characteristics should be delineated. The corollary challenge is to identify the low risk patients so that inappropriate resources are not focused where such efforts might not be necessary.

Individual hospital policies are integral to this issue, as the relative value of rapid response teams appears to vary greatly. Add to the equation a recent Wall Street Journal article (http://online.wsj.com/search/term.html?KEYWORDS=Heart%20attack) that highlighted the success of managing heart attacks outside the hospital but the notable challenges of managing those events when they occur within the inpatient population.

Another key challenge facing roundtable participants will be to focus their discussions on what clinical parameters should be monitored and which, if any, should be put on the back burner. There is a relatively wide variation of views regarding what should be monitored, what thresholds are problematic and indicative of a declining patient, and what actions need to be taken, and how swiftly, to abate the downward cascade of respiratory compromise. A related challenge facing participants is, “should the industry be moving toward refinement of their monitoring technologies to give physicians and the health-care team more valuable and more timely information? Are we monitoring the right parameters, or are we monitoring what the technology allows us to monitor? Are there gaps that can be addressed?”

While no one is confident of the specific direction these discussions will take, it is likely that not only will the proceedings be documented for submission for publication, but it may very well lead to other conferences that focus on respiratory compromise in other settings. Both the skilled nursing facility and long-term acute care hospital settings provide care for a spectrum of pulmonary/ventilator patients, and the characteristics of their potential cascade of deterioration may or may not be the same as in an acute care hospital. The challenges are similar, but solutions may be different—a subject for further discussion.

This conference is just one example of NAMDRC’s approach to a range of pulmonary-related clinical issues. While NAMDRC’s broad mission is to “improve access to quality care for patients with respiratory disease by removing regulatory and legislative barriers to appropriate treatment,” the roundtable does fit into the mission because of growing concerns that we are facing challenges that are solvable if we take the initiative to address solutions to these challenges.

Another very broad challenge facing NAMDRC is its belief that the growing area of home mechanical ventilation is being shaped by archaic and outdated legislation and regulation. In fact, in a discussion with Marilyn Tavenner, CMS Administrator (and critical care nurse by training) last August, she conceded that the laws and regulations have not kept pace with innovations as basic as noninvasive mechanical ventilation. The idea that mechanical ventilation involves intubation or tracheostomy is universally recognized as archaic. As archaic is the concept that, by definition, ending mechanical ventilation leads to imminent death. While that may have reflected technologies of the 1980s and early 1990s, it is not reflective of today’s standards of care. Amending the existing laws and regulations in this area may become a high priority for NAMDRC over the next few years.

For membership information, visit the NAMDRC website at www.namdrc.org or call 703/752-4359.

NAMDRC is bringing together representatives of key medical societies, including CHEST, ATS, AARC, SCCM, AACN, SHM (hospitalists), PPAHS (patient safety), and ACEP (emergency physicians) to address respiratory compromise, that cascade of events that moves from respiratory insufficiency to respiratory failure to respiratory arrest. Recognizing that respiratory compromise occurs in various settings, the conference, Feb 26-27 in Orlando, Florida, will focus on the hospital setting.

In addition to society representatives, the NAMDRC leadership, in consultation with recognized experts, has also invited several key opinion leaders to participate, including physicians, respiratory therapists, and nurses.

There are several challenges facing the participants, perhaps paramount is to define the concept of “respiratory compromise.” Some of have signaled, “I know it when I see it,” but the expectation is to formulate a specific clinical definition of the respiratory deterioration, and devise a recognition pathway that can easily be used in the hospital setting to identify patients earlier in the course of this cascade.

How to identify high risk patients is critical to the discussion, because it is generally believed that this is where resources need to be focused, both from a personnel and monitoring perspective. Can consensus be drawn to determine which patient characteristics can reliably classify that patient into a high risk for respiratory compromise, and, if so, those characteristics should be delineated. The corollary challenge is to identify the low risk patients so that inappropriate resources are not focused where such efforts might not be necessary.

Individual hospital policies are integral to this issue, as the relative value of rapid response teams appears to vary greatly. Add to the equation a recent Wall Street Journal article (http://online.wsj.com/search/term.html?KEYWORDS=Heart%20attack) that highlighted the success of managing heart attacks outside the hospital but the notable challenges of managing those events when they occur within the inpatient population.

Another key challenge facing roundtable participants will be to focus their discussions on what clinical parameters should be monitored and which, if any, should be put on the back burner. There is a relatively wide variation of views regarding what should be monitored, what thresholds are problematic and indicative of a declining patient, and what actions need to be taken, and how swiftly, to abate the downward cascade of respiratory compromise. A related challenge facing participants is, “should the industry be moving toward refinement of their monitoring technologies to give physicians and the health-care team more valuable and more timely information? Are we monitoring the right parameters, or are we monitoring what the technology allows us to monitor? Are there gaps that can be addressed?”

While no one is confident of the specific direction these discussions will take, it is likely that not only will the proceedings be documented for submission for publication, but it may very well lead to other conferences that focus on respiratory compromise in other settings. Both the skilled nursing facility and long-term acute care hospital settings provide care for a spectrum of pulmonary/ventilator patients, and the characteristics of their potential cascade of deterioration may or may not be the same as in an acute care hospital. The challenges are similar, but solutions may be different—a subject for further discussion.

This conference is just one example of NAMDRC’s approach to a range of pulmonary-related clinical issues. While NAMDRC’s broad mission is to “improve access to quality care for patients with respiratory disease by removing regulatory and legislative barriers to appropriate treatment,” the roundtable does fit into the mission because of growing concerns that we are facing challenges that are solvable if we take the initiative to address solutions to these challenges.

Another very broad challenge facing NAMDRC is its belief that the growing area of home mechanical ventilation is being shaped by archaic and outdated legislation and regulation. In fact, in a discussion with Marilyn Tavenner, CMS Administrator (and critical care nurse by training) last August, she conceded that the laws and regulations have not kept pace with innovations as basic as noninvasive mechanical ventilation. The idea that mechanical ventilation involves intubation or tracheostomy is universally recognized as archaic. As archaic is the concept that, by definition, ending mechanical ventilation leads to imminent death. While that may have reflected technologies of the 1980s and early 1990s, it is not reflective of today’s standards of care. Amending the existing laws and regulations in this area may become a high priority for NAMDRC over the next few years.

For membership information, visit the NAMDRC website at www.namdrc.org or call 703/752-4359.

NAMDRC is bringing together representatives of key medical societies, including CHEST, ATS, AARC, SCCM, AACN, SHM (hospitalists), PPAHS (patient safety), and ACEP (emergency physicians) to address respiratory compromise, that cascade of events that moves from respiratory insufficiency to respiratory failure to respiratory arrest. Recognizing that respiratory compromise occurs in various settings, the conference, Feb 26-27 in Orlando, Florida, will focus on the hospital setting.

In addition to society representatives, the NAMDRC leadership, in consultation with recognized experts, has also invited several key opinion leaders to participate, including physicians, respiratory therapists, and nurses.

There are several challenges facing the participants, perhaps paramount is to define the concept of “respiratory compromise.” Some of have signaled, “I know it when I see it,” but the expectation is to formulate a specific clinical definition of the respiratory deterioration, and devise a recognition pathway that can easily be used in the hospital setting to identify patients earlier in the course of this cascade.

How to identify high risk patients is critical to the discussion, because it is generally believed that this is where resources need to be focused, both from a personnel and monitoring perspective. Can consensus be drawn to determine which patient characteristics can reliably classify that patient into a high risk for respiratory compromise, and, if so, those characteristics should be delineated. The corollary challenge is to identify the low risk patients so that inappropriate resources are not focused where such efforts might not be necessary.

Individual hospital policies are integral to this issue, as the relative value of rapid response teams appears to vary greatly. Add to the equation a recent Wall Street Journal article (http://online.wsj.com/search/term.html?KEYWORDS=Heart%20attack) that highlighted the success of managing heart attacks outside the hospital but the notable challenges of managing those events when they occur within the inpatient population.

Another key challenge facing roundtable participants will be to focus their discussions on what clinical parameters should be monitored and which, if any, should be put on the back burner. There is a relatively wide variation of views regarding what should be monitored, what thresholds are problematic and indicative of a declining patient, and what actions need to be taken, and how swiftly, to abate the downward cascade of respiratory compromise. A related challenge facing participants is, “should the industry be moving toward refinement of their monitoring technologies to give physicians and the health-care team more valuable and more timely information? Are we monitoring the right parameters, or are we monitoring what the technology allows us to monitor? Are there gaps that can be addressed?”

While no one is confident of the specific direction these discussions will take, it is likely that not only will the proceedings be documented for submission for publication, but it may very well lead to other conferences that focus on respiratory compromise in other settings. Both the skilled nursing facility and long-term acute care hospital settings provide care for a spectrum of pulmonary/ventilator patients, and the characteristics of their potential cascade of deterioration may or may not be the same as in an acute care hospital. The challenges are similar, but solutions may be different—a subject for further discussion.

This conference is just one example of NAMDRC’s approach to a range of pulmonary-related clinical issues. While NAMDRC’s broad mission is to “improve access to quality care for patients with respiratory disease by removing regulatory and legislative barriers to appropriate treatment,” the roundtable does fit into the mission because of growing concerns that we are facing challenges that are solvable if we take the initiative to address solutions to these challenges.

Another very broad challenge facing NAMDRC is its belief that the growing area of home mechanical ventilation is being shaped by archaic and outdated legislation and regulation. In fact, in a discussion with Marilyn Tavenner, CMS Administrator (and critical care nurse by training) last August, she conceded that the laws and regulations have not kept pace with innovations as basic as noninvasive mechanical ventilation. The idea that mechanical ventilation involves intubation or tracheostomy is universally recognized as archaic. As archaic is the concept that, by definition, ending mechanical ventilation leads to imminent death. While that may have reflected technologies of the 1980s and early 1990s, it is not reflective of today’s standards of care. Amending the existing laws and regulations in this area may become a high priority for NAMDRC over the next few years.

For membership information, visit the NAMDRC website at www.namdrc.org or call 703/752-4359.