NAMDRC Legislative and Regulatory Agenda Once Again Focuses on Patient Access

 

NAMDRC’s Mission Statement declares, “NAMDRC’s primary mission is to improve access to quality care for patients with respiratory disease by removing regulatory and legislative barriers to appropriate treatment.” This mission is clear as we review our legislative and regulatory agenda on an ongoing and continuing basis.

Home Mechanical Ventilation: Close to 20 years ago, HCFA (now CMS) was faced with an important reality: advances in technology related to home mechanical ventilation are triggering an exponential growth in availability of these life supporting devices, but a price would be paid. At that time, Medicare law was quite explicit, indicating that certain ventilators would be paid under a “frequent and substantial servicing” payment methodology, authorizing payment on an ongoing basis as long as the prescribing physician documented medical necessity. To circumvent that statutory reality, the agency created a new category of medical device – a respiratory assist device/RAD – and declared that these devices are no longer ventilators and are now subject to capped rental rules and regulations.

NAMDRC was determined to work within the system, but roadblocks were consistently encountered, ie, contractor policies that did not reflect current medical standards of care, peer reviewed literature, etc. Even defining a “respiratory assist device” was (and still is) a challenge, as the term does not appear in the medical literature or in FDA vernacular.

Spin forward to 2018 and numerous realities come into play. Physicians still struggle with the concept of RADs without a definitive, consistent definition and no FDA language to guide usage. Today, it is easier to secure a ventilator if a physician documents the patient experiences some level of respiratory failure than it is to prescribe a simple ventilator with a back-up rate. Because of that dichotomy, the growth of life support ventilator usage is well documented.

If one takes the approach that a device should be paired with the actual clinical characteristics/medical need of the patient, changes in policy are necessary. While CMS clearly has the authority to act to improve policy and match clinical need to patient access, years and years of back and forth have signaled a definite unwillingness of the agency to move in that direction; therefore, the only genuine recourse is to seek legislative relief.

NAMDRC is working closely with the United States Senate, particularly the Finance Committee, Senator Cassidy (R-LA), and the Office of Senate Legislative Counsel to craft legislative language to address the myriad of issues associated with home mechanical ventilation.

 

Home Oxygen Therapy: In 1986, Congress revamped the statute governing coverage and payment of home oxygen. Pondering the reality of a segment of pulmonary medicine that has seen dramatic technological improvements and enhancements over the past 30-plus years, coupled with a payment system that is stuck with e-cylinders and competitive bidding, it is no wonder that both patients and physicians experience ongoing frustration trying to match a patient’s needs with an oxygen system that reflects the patient’s needs.

It’s a challenge to even consider where to start a reasonable discussion of home oxygen therapy. While the concept of supplemental oxygen is well accepted, the actual clinical evidence relies heavily on a very small number of studies. While virtually no one challenges the concept of the therapy, the actual science has progressed modestly in 30-plus years. But the technology surrounding oxygen therapy has become an industry all to itself. There are concentrators, portable oxygen concentrators, liquid systems, transfill systems, transtracheal oxygen therapy, and so on.

Add to the environment the growing demand for high flow systems that would deliver continuous flow oxygen at rates in excess of 4 L/min, and you begin to realize that the current payment system is a barrier to access. After all, the current payment system has problematic characteristics:

1. A flawed competitive bidding methodology;

2. Payment tied to liter flow pegged at a baseline of 2 L/min, regardless of actual patient need;

3. The major shift from a “delivery model” of care to a nondelivery model that reflects these newer technologies;

4. Virtual disappearance of liquid system availability as an option for physicians/patients;

5. The total failure of CMS to monitor, let alone act on, patient concerns.

Again, taking the NAMDRC Mission Statement into context, NAMDRC is working with all the key societies to craft a broad strategy to address these problems, acknowledging that it will likely take a mix of legislative and regulatory actions to bring home oxygen therapy into the 21st century, let alone to reflect realities of care in 2018.

 

NAMDRC’s Mission Statement declares, “NAMDRC’s primary mission is to improve access to quality care for patients with respiratory disease by removing regulatory and legislative barriers to appropriate treatment.” This mission is clear as we review our legislative and regulatory agenda on an ongoing and continuing basis.

Home Mechanical Ventilation: Close to 20 years ago, HCFA (now CMS) was faced with an important reality: advances in technology related to home mechanical ventilation are triggering an exponential growth in availability of these life supporting devices, but a price would be paid. At that time, Medicare law was quite explicit, indicating that certain ventilators would be paid under a “frequent and substantial servicing” payment methodology, authorizing payment on an ongoing basis as long as the prescribing physician documented medical necessity. To circumvent that statutory reality, the agency created a new category of medical device – a respiratory assist device/RAD – and declared that these devices are no longer ventilators and are now subject to capped rental rules and regulations.

NAMDRC was determined to work within the system, but roadblocks were consistently encountered, ie, contractor policies that did not reflect current medical standards of care, peer reviewed literature, etc. Even defining a “respiratory assist device” was (and still is) a challenge, as the term does not appear in the medical literature or in FDA vernacular.

Spin forward to 2018 and numerous realities come into play. Physicians still struggle with the concept of RADs without a definitive, consistent definition and no FDA language to guide usage. Today, it is easier to secure a ventilator if a physician documents the patient experiences some level of respiratory failure than it is to prescribe a simple ventilator with a back-up rate. Because of that dichotomy, the growth of life support ventilator usage is well documented.

If one takes the approach that a device should be paired with the actual clinical characteristics/medical need of the patient, changes in policy are necessary. While CMS clearly has the authority to act to improve policy and match clinical need to patient access, years and years of back and forth have signaled a definite unwillingness of the agency to move in that direction; therefore, the only genuine recourse is to seek legislative relief.

NAMDRC is working closely with the United States Senate, particularly the Finance Committee, Senator Cassidy (R-LA), and the Office of Senate Legislative Counsel to craft legislative language to address the myriad of issues associated with home mechanical ventilation.

 

Home Oxygen Therapy: In 1986, Congress revamped the statute governing coverage and payment of home oxygen. Pondering the reality of a segment of pulmonary medicine that has seen dramatic technological improvements and enhancements over the past 30-plus years, coupled with a payment system that is stuck with e-cylinders and competitive bidding, it is no wonder that both patients and physicians experience ongoing frustration trying to match a patient’s needs with an oxygen system that reflects the patient’s needs.

It’s a challenge to even consider where to start a reasonable discussion of home oxygen therapy. While the concept of supplemental oxygen is well accepted, the actual clinical evidence relies heavily on a very small number of studies. While virtually no one challenges the concept of the therapy, the actual science has progressed modestly in 30-plus years. But the technology surrounding oxygen therapy has become an industry all to itself. There are concentrators, portable oxygen concentrators, liquid systems, transfill systems, transtracheal oxygen therapy, and so on.

Add to the environment the growing demand for high flow systems that would deliver continuous flow oxygen at rates in excess of 4 L/min, and you begin to realize that the current payment system is a barrier to access. After all, the current payment system has problematic characteristics:

1. A flawed competitive bidding methodology;

2. Payment tied to liter flow pegged at a baseline of 2 L/min, regardless of actual patient need;

3. The major shift from a “delivery model” of care to a nondelivery model that reflects these newer technologies;

4. Virtual disappearance of liquid system availability as an option for physicians/patients;

5. The total failure of CMS to monitor, let alone act on, patient concerns.

Again, taking the NAMDRC Mission Statement into context, NAMDRC is working with all the key societies to craft a broad strategy to address these problems, acknowledging that it will likely take a mix of legislative and regulatory actions to bring home oxygen therapy into the 21st century, let alone to reflect realities of care in 2018.

 

NAMDRC’s Mission Statement declares, “NAMDRC’s primary mission is to improve access to quality care for patients with respiratory disease by removing regulatory and legislative barriers to appropriate treatment.” This mission is clear as we review our legislative and regulatory agenda on an ongoing and continuing basis.

Home Mechanical Ventilation: Close to 20 years ago, HCFA (now CMS) was faced with an important reality: advances in technology related to home mechanical ventilation are triggering an exponential growth in availability of these life supporting devices, but a price would be paid. At that time, Medicare law was quite explicit, indicating that certain ventilators would be paid under a “frequent and substantial servicing” payment methodology, authorizing payment on an ongoing basis as long as the prescribing physician documented medical necessity. To circumvent that statutory reality, the agency created a new category of medical device – a respiratory assist device/RAD – and declared that these devices are no longer ventilators and are now subject to capped rental rules and regulations.

NAMDRC was determined to work within the system, but roadblocks were consistently encountered, ie, contractor policies that did not reflect current medical standards of care, peer reviewed literature, etc. Even defining a “respiratory assist device” was (and still is) a challenge, as the term does not appear in the medical literature or in FDA vernacular.

Spin forward to 2018 and numerous realities come into play. Physicians still struggle with the concept of RADs without a definitive, consistent definition and no FDA language to guide usage. Today, it is easier to secure a ventilator if a physician documents the patient experiences some level of respiratory failure than it is to prescribe a simple ventilator with a back-up rate. Because of that dichotomy, the growth of life support ventilator usage is well documented.

If one takes the approach that a device should be paired with the actual clinical characteristics/medical need of the patient, changes in policy are necessary. While CMS clearly has the authority to act to improve policy and match clinical need to patient access, years and years of back and forth have signaled a definite unwillingness of the agency to move in that direction; therefore, the only genuine recourse is to seek legislative relief.

NAMDRC is working closely with the United States Senate, particularly the Finance Committee, Senator Cassidy (R-LA), and the Office of Senate Legislative Counsel to craft legislative language to address the myriad of issues associated with home mechanical ventilation.

 

Home Oxygen Therapy: In 1986, Congress revamped the statute governing coverage and payment of home oxygen. Pondering the reality of a segment of pulmonary medicine that has seen dramatic technological improvements and enhancements over the past 30-plus years, coupled with a payment system that is stuck with e-cylinders and competitive bidding, it is no wonder that both patients and physicians experience ongoing frustration trying to match a patient’s needs with an oxygen system that reflects the patient’s needs.

It’s a challenge to even consider where to start a reasonable discussion of home oxygen therapy. While the concept of supplemental oxygen is well accepted, the actual clinical evidence relies heavily on a very small number of studies. While virtually no one challenges the concept of the therapy, the actual science has progressed modestly in 30-plus years. But the technology surrounding oxygen therapy has become an industry all to itself. There are concentrators, portable oxygen concentrators, liquid systems, transfill systems, transtracheal oxygen therapy, and so on.

Add to the environment the growing demand for high flow systems that would deliver continuous flow oxygen at rates in excess of 4 L/min, and you begin to realize that the current payment system is a barrier to access. After all, the current payment system has problematic characteristics:

1. A flawed competitive bidding methodology;

2. Payment tied to liter flow pegged at a baseline of 2 L/min, regardless of actual patient need;

3. The major shift from a “delivery model” of care to a nondelivery model that reflects these newer technologies;

4. Virtual disappearance of liquid system availability as an option for physicians/patients;

5. The total failure of CMS to monitor, let alone act on, patient concerns.

Again, taking the NAMDRC Mission Statement into context, NAMDRC is working with all the key societies to craft a broad strategy to address these problems, acknowledging that it will likely take a mix of legislative and regulatory actions to bring home oxygen therapy into the 21st century, let alone to reflect realities of care in 2018.