Phil Porte, Executive Director, NAMDRC

In mid-September, NAMDRC, along with the American Thoracic Society, the American Association for Respiratory Care, the COPD Foundation, the American Lung Association, and others met to discuss the components of a legislative agenda for the coming years. The primary purpose behind the meeting was the premise that IF the current Republican majority would shift in either the House or Senate after the 2018 election, the community should be prepared to move an already agreed upon legislative agenda. CHEST was involved in the preliminary discussions, as well as follow-up, but was not in attendance at the meeting due to a scheduling conflict. There was also tacit agreement that as these policies are fleshed out and crafted into specific legislative language, the community would re-evaluate the current political climate to determine the value of pushing an agreed upon agenda prior to the 2018 elections.

Various patient groups were also invited to participate, but scheduling conflicts precluded some societies from participating but signaled their desire to work with the broad pulmonary medicine community to pursue common goals.

Each society brought its legislative priorities to the table, and there was active discussion on issues ranging from funding for NIH/NHLBI, to CDC and its COPD Action Plan, to a range of Medicare-related issues.

NAMDRC brought three specific Medicare coverage and payment issues to the discussion: home mechanical ventilation, payment for high flow oxygen therapy, and site of service/Section 603 issues.

Home mechanical ventilation is admittedly a complex issue, but it is moving forward in at least two political directions. First, Senator Bill Cassidy (R-LA) and a physician by training, has signaled his desire to move this issue forward, either legislatively or giving CMS one last chance to move forward through the regulatory structure. He agrees that a payment system that inhibits access to appropriate bi-level mechanical ventilators and encourages access to more complex life-sustaining ventilators, regardless of documented medical need, is appropriate. While CMS does have the authority to act, it has chosen to ignore repeated requests for action over the past 4 years.

Ironically, the House Energy and Commerce Committee, which shares jurisdiction on the House of Representatives with the Ways and Means Committee on Medicare issues, has sent a request to the Congressional Budget Office to provide a cost estimate (a “score” in Washington vernacular) of likely savings from a legislative solution to this matter. In the current political climate, a legislative proposal that actually saves $$$ is politically attractive, and we are working both the regulatory and legislative pathway to seek a workable solution.

On the oxygen therapy issue, there is growing evidence that, for a small group of Medicare beneficiaries who need high flow oxygen therapy as their disease progresses (pulmonary fibrosis, end-stage COPD, etc), there are no oxygen systems readily available to meet that need outside the home. At home, numerous concentrators can meet that need, but outside the home, the ideal solution, liquid systems, is not readily available because of the payment system tied to competitive bidding. CMS payment data indicate that a very low percentage of oxygen users need more than 4 liters per minute, and current law would make a payment adjustment unique to certain patients a very difficult hurdle, particularly in the era of competitive bidding, a legislative change is the best solution facing the community. The challenge is to craft legislative language that addresses the need but would preclude abuse by suppliers who might jump at the chance for higher payment for liquid, well above current payment levels. And because liquid systems fit into a “delivery model” business plan, contrary to portable oxygen concentrators and transfill systems, the solution is not as easy as a payment bump to make provision of liquid systems more attractive.

Site of service regulations are hitting pulmonary rehabilitation particularly hard, and CMS concedes that the only solution is a legislative one. Under current policy, a pulmonary rehab program that is located off campus but needs to expand or move from its current location (losing a lease, for example), if the expanded program is NOT within 250 yards of the main hospital campus, the program is then reimbursed at the physician fee schedule rate, a rate cut of approximately 50%. Needless to say, hospitals are not pursuing that approach. Likewise, a hospital that chooses to open a NEW program is also constrained, needing to locate within 250 yards of the main campus or face the dramatic cut in payment.

As these issues evolve and the political climate perhaps opens unique opportunities, we can expect the broad pulmonary community to pursue these and other issues.

In mid-September, NAMDRC, along with the American Thoracic Society, the American Association for Respiratory Care, the COPD Foundation, the American Lung Association, and others met to discuss the components of a legislative agenda for the coming years. The primary purpose behind the meeting was the premise that IF the current Republican majority would shift in either the House or Senate after the 2018 election, the community should be prepared to move an already agreed upon legislative agenda. CHEST was involved in the preliminary discussions, as well as follow-up, but was not in attendance at the meeting due to a scheduling conflict. There was also tacit agreement that as these policies are fleshed out and crafted into specific legislative language, the community would re-evaluate the current political climate to determine the value of pushing an agreed upon agenda prior to the 2018 elections.

Various patient groups were also invited to participate, but scheduling conflicts precluded some societies from participating but signaled their desire to work with the broad pulmonary medicine community to pursue common goals.

Each society brought its legislative priorities to the table, and there was active discussion on issues ranging from funding for NIH/NHLBI, to CDC and its COPD Action Plan, to a range of Medicare-related issues.

NAMDRC brought three specific Medicare coverage and payment issues to the discussion: home mechanical ventilation, payment for high flow oxygen therapy, and site of service/Section 603 issues.

Home mechanical ventilation is admittedly a complex issue, but it is moving forward in at least two political directions. First, Senator Bill Cassidy (R-LA) and a physician by training, has signaled his desire to move this issue forward, either legislatively or giving CMS one last chance to move forward through the regulatory structure. He agrees that a payment system that inhibits access to appropriate bi-level mechanical ventilators and encourages access to more complex life-sustaining ventilators, regardless of documented medical need, is appropriate. While CMS does have the authority to act, it has chosen to ignore repeated requests for action over the past 4 years.

Ironically, the House Energy and Commerce Committee, which shares jurisdiction on the House of Representatives with the Ways and Means Committee on Medicare issues, has sent a request to the Congressional Budget Office to provide a cost estimate (a “score” in Washington vernacular) of likely savings from a legislative solution to this matter. In the current political climate, a legislative proposal that actually saves $$$ is politically attractive, and we are working both the regulatory and legislative pathway to seek a workable solution.

On the oxygen therapy issue, there is growing evidence that, for a small group of Medicare beneficiaries who need high flow oxygen therapy as their disease progresses (pulmonary fibrosis, end-stage COPD, etc), there are no oxygen systems readily available to meet that need outside the home. At home, numerous concentrators can meet that need, but outside the home, the ideal solution, liquid systems, is not readily available because of the payment system tied to competitive bidding. CMS payment data indicate that a very low percentage of oxygen users need more than 4 liters per minute, and current law would make a payment adjustment unique to certain patients a very difficult hurdle, particularly in the era of competitive bidding, a legislative change is the best solution facing the community. The challenge is to craft legislative language that addresses the need but would preclude abuse by suppliers who might jump at the chance for higher payment for liquid, well above current payment levels. And because liquid systems fit into a “delivery model” business plan, contrary to portable oxygen concentrators and transfill systems, the solution is not as easy as a payment bump to make provision of liquid systems more attractive.

Site of service regulations are hitting pulmonary rehabilitation particularly hard, and CMS concedes that the only solution is a legislative one. Under current policy, a pulmonary rehab program that is located off campus but needs to expand or move from its current location (losing a lease, for example), if the expanded program is NOT within 250 yards of the main hospital campus, the program is then reimbursed at the physician fee schedule rate, a rate cut of approximately 50%. Needless to say, hospitals are not pursuing that approach. Likewise, a hospital that chooses to open a NEW program is also constrained, needing to locate within 250 yards of the main campus or face the dramatic cut in payment.

As these issues evolve and the political climate perhaps opens unique opportunities, we can expect the broad pulmonary community to pursue these and other issues.

In mid-September, NAMDRC, along with the American Thoracic Society, the American Association for Respiratory Care, the COPD Foundation, the American Lung Association, and others met to discuss the components of a legislative agenda for the coming years. The primary purpose behind the meeting was the premise that IF the current Republican majority would shift in either the House or Senate after the 2018 election, the community should be prepared to move an already agreed upon legislative agenda. CHEST was involved in the preliminary discussions, as well as follow-up, but was not in attendance at the meeting due to a scheduling conflict. There was also tacit agreement that as these policies are fleshed out and crafted into specific legislative language, the community would re-evaluate the current political climate to determine the value of pushing an agreed upon agenda prior to the 2018 elections.

Various patient groups were also invited to participate, but scheduling conflicts precluded some societies from participating but signaled their desire to work with the broad pulmonary medicine community to pursue common goals.

Each society brought its legislative priorities to the table, and there was active discussion on issues ranging from funding for NIH/NHLBI, to CDC and its COPD Action Plan, to a range of Medicare-related issues.

NAMDRC brought three specific Medicare coverage and payment issues to the discussion: home mechanical ventilation, payment for high flow oxygen therapy, and site of service/Section 603 issues.

Home mechanical ventilation is admittedly a complex issue, but it is moving forward in at least two political directions. First, Senator Bill Cassidy (R-LA) and a physician by training, has signaled his desire to move this issue forward, either legislatively or giving CMS one last chance to move forward through the regulatory structure. He agrees that a payment system that inhibits access to appropriate bi-level mechanical ventilators and encourages access to more complex life-sustaining ventilators, regardless of documented medical need, is appropriate. While CMS does have the authority to act, it has chosen to ignore repeated requests for action over the past 4 years.

Ironically, the House Energy and Commerce Committee, which shares jurisdiction on the House of Representatives with the Ways and Means Committee on Medicare issues, has sent a request to the Congressional Budget Office to provide a cost estimate (a “score” in Washington vernacular) of likely savings from a legislative solution to this matter. In the current political climate, a legislative proposal that actually saves $$$ is politically attractive, and we are working both the regulatory and legislative pathway to seek a workable solution.

On the oxygen therapy issue, there is growing evidence that, for a small group of Medicare beneficiaries who need high flow oxygen therapy as their disease progresses (pulmonary fibrosis, end-stage COPD, etc), there are no oxygen systems readily available to meet that need outside the home. At home, numerous concentrators can meet that need, but outside the home, the ideal solution, liquid systems, is not readily available because of the payment system tied to competitive bidding. CMS payment data indicate that a very low percentage of oxygen users need more than 4 liters per minute, and current law would make a payment adjustment unique to certain patients a very difficult hurdle, particularly in the era of competitive bidding, a legislative change is the best solution facing the community. The challenge is to craft legislative language that addresses the need but would preclude abuse by suppliers who might jump at the chance for higher payment for liquid, well above current payment levels. And because liquid systems fit into a “delivery model” business plan, contrary to portable oxygen concentrators and transfill systems, the solution is not as easy as a payment bump to make provision of liquid systems more attractive.

Site of service regulations are hitting pulmonary rehabilitation particularly hard, and CMS concedes that the only solution is a legislative one. Under current policy, a pulmonary rehab program that is located off campus but needs to expand or move from its current location (losing a lease, for example), if the expanded program is NOT within 250 yards of the main hospital campus, the program is then reimbursed at the physician fee schedule rate, a rate cut of approximately 50%. Needless to say, hospitals are not pursuing that approach. Likewise, a hospital that chooses to open a NEW program is also constrained, needing to locate within 250 yards of the main campus or face the dramatic cut in payment.

As these issues evolve and the political climate perhaps opens unique opportunities, we can expect the broad pulmonary community to pursue these and other issues.

The old adage of not wanting to see how laws or sausage is made holds true today, perhaps more so than ever. But certain clinical realities within pulmonary medicine virtually ensure that legislation is actually part of any reasonable solution.

NAMDRC has initiated an outreach to all the key medical, allied health, and patient societies that focus on pulmonary medicine to determine if consensus can be reached on a focused laundry list of issues that, for varying reasons, lean toward Congress for legislative solutions.

Here is a list of some of the issues under discussion:

• Home mechanical ventilation. Under current law, “ventilators” are covered items under the durable medical equipment benefit. In the 1990s, in order to circumvent statutory requirements that ventilators be paid under a “frequent and substantial servicing” payment methodology, HCFA (now CMS) created a new category – respiratory assist devices and declared that these devices, despite classification by FDA as ventilators, are not ventilators in reality, and the payment methodology, therefore, does not apply.

Over the past several years, the pulmonary medicine community tried its best to convince CMS that its rules were problematic, archaic, and costing the Medicare program tens of millions of dollars in unnecessary expenditures. A formal submission to CMS, a request for a National Coverage Determination reconsideration, was denied with a phrase now echoed throughout health care, “it’s complicated.” The only effective solution is a legislative one.

• High flow oxygen therapy for ILD patients. Oxygen remains the largest single component of the durable medical equipment benefit and, largely due to competitive bidding, has seen payment drop dramatically since the implementation of competitive bidding.

One can easily argue that competitive pricing is self-inflicted by the DME industry as the rates are set through a complicated formula based on bids from suppliers. But the impact has been particularly hard on liquid systems, the delivery system choice of not only many Medicare beneficiaries but also is the modality of choice for patients with clear need for high flow oxygen. While delivery in the home for high flow needs can be met by some stationary concentrators, the virtual disappearance of liquid systems, attributable to pricing triggered by competitive bidding, results in many ILD patients unable to leave their homes. The only effective solution is a legislative one.

• Section 603. This provision of the Balanced Budget Act of 2015 was designed to inhibit hospital purchases of certain physician practices that were based on aberrations within the Medicare payment system that rewarded hospitals significantly more than the same service provided in a physician office. For example, a physician office-based sleep lab may be able to bill Medicare for a particular service, but if the hospital purchases that physician practice and bills for the same service, it might receive upwards of twice as much payment.

While all involved seem to agree that this provision was not intended to target pulmonary rehabilitation services, it is being hit particularly hard by CMS rules implementing the statute. Any new pulmonary rehab program that is not within 250 yards of the main hospital campus must bill at the physician fee schedule rate, a rate about half of the hospital outpatient rate. Furthermore, existing programs that choose to expand must do so within the confines of their specific current location, unable to move a floor away. Doing so would trigger the reduced payment methodology.
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CMS agrees this is clearly an example of unintended consequences, but CMS also acknowledges it does not have the authority to remedy the situation. The agency itself signaled the only way to exempt pulmonary rehabilitation services is to seek Congressional action.

And now to the “sausage” part of the equation. Congressional action on virtually anything except renaming a post office becomes a political, as well as substantive, challenge. Here are just some of the considerations that must be addressed by any legislative strategy.
 

1. Any “fix” must be clinically sound and supported across a broad cross section of physician and patient groups. And the fix must give some level of flexibility to CMS to implement it in a reasonable way but tie their hands to force changes in policy.

2. Any “fix” must have a strong political strategy that can muster support within key Congressional committees (House Ways & Means Committee and Energy & Commerce Committee, along with the Senate Finance Committee, let alone 218 votes in the House and 51 votes in the Senate.

Given these issues, almost regardless of the political environment, it is time to begin working on substantive solutions so that when the political climate improves, pulmonary medicine is ready to move forward with a coordinated cohesive strategy.

The old adage of not wanting to see how laws or sausage is made holds true today, perhaps more so than ever. But certain clinical realities within pulmonary medicine virtually ensure that legislation is actually part of any reasonable solution.

NAMDRC has initiated an outreach to all the key medical, allied health, and patient societies that focus on pulmonary medicine to determine if consensus can be reached on a focused laundry list of issues that, for varying reasons, lean toward Congress for legislative solutions.

Here is a list of some of the issues under discussion:

• Home mechanical ventilation. Under current law, “ventilators” are covered items under the durable medical equipment benefit. In the 1990s, in order to circumvent statutory requirements that ventilators be paid under a “frequent and substantial servicing” payment methodology, HCFA (now CMS) created a new category – respiratory assist devices and declared that these devices, despite classification by FDA as ventilators, are not ventilators in reality, and the payment methodology, therefore, does not apply.

Over the past several years, the pulmonary medicine community tried its best to convince CMS that its rules were problematic, archaic, and costing the Medicare program tens of millions of dollars in unnecessary expenditures. A formal submission to CMS, a request for a National Coverage Determination reconsideration, was denied with a phrase now echoed throughout health care, “it’s complicated.” The only effective solution is a legislative one.

• High flow oxygen therapy for ILD patients. Oxygen remains the largest single component of the durable medical equipment benefit and, largely due to competitive bidding, has seen payment drop dramatically since the implementation of competitive bidding.

One can easily argue that competitive pricing is self-inflicted by the DME industry as the rates are set through a complicated formula based on bids from suppliers. But the impact has been particularly hard on liquid systems, the delivery system choice of not only many Medicare beneficiaries but also is the modality of choice for patients with clear need for high flow oxygen. While delivery in the home for high flow needs can be met by some stationary concentrators, the virtual disappearance of liquid systems, attributable to pricing triggered by competitive bidding, results in many ILD patients unable to leave their homes. The only effective solution is a legislative one.

• Section 603. This provision of the Balanced Budget Act of 2015 was designed to inhibit hospital purchases of certain physician practices that were based on aberrations within the Medicare payment system that rewarded hospitals significantly more than the same service provided in a physician office. For example, a physician office-based sleep lab may be able to bill Medicare for a particular service, but if the hospital purchases that physician practice and bills for the same service, it might receive upwards of twice as much payment.

While all involved seem to agree that this provision was not intended to target pulmonary rehabilitation services, it is being hit particularly hard by CMS rules implementing the statute. Any new pulmonary rehab program that is not within 250 yards of the main hospital campus must bill at the physician fee schedule rate, a rate about half of the hospital outpatient rate. Furthermore, existing programs that choose to expand must do so within the confines of their specific current location, unable to move a floor away. Doing so would trigger the reduced payment methodology.
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CMS agrees this is clearly an example of unintended consequences, but CMS also acknowledges it does not have the authority to remedy the situation. The agency itself signaled the only way to exempt pulmonary rehabilitation services is to seek Congressional action.

And now to the “sausage” part of the equation. Congressional action on virtually anything except renaming a post office becomes a political, as well as substantive, challenge. Here are just some of the considerations that must be addressed by any legislative strategy.
 

1. Any “fix” must be clinically sound and supported across a broad cross section of physician and patient groups. And the fix must give some level of flexibility to CMS to implement it in a reasonable way but tie their hands to force changes in policy.

2. Any “fix” must have a strong political strategy that can muster support within key Congressional committees (House Ways & Means Committee and Energy & Commerce Committee, along with the Senate Finance Committee, let alone 218 votes in the House and 51 votes in the Senate.

Given these issues, almost regardless of the political environment, it is time to begin working on substantive solutions so that when the political climate improves, pulmonary medicine is ready to move forward with a coordinated cohesive strategy.

The old adage of not wanting to see how laws or sausage is made holds true today, perhaps more so than ever. But certain clinical realities within pulmonary medicine virtually ensure that legislation is actually part of any reasonable solution.

NAMDRC has initiated an outreach to all the key medical, allied health, and patient societies that focus on pulmonary medicine to determine if consensus can be reached on a focused laundry list of issues that, for varying reasons, lean toward Congress for legislative solutions.

Here is a list of some of the issues under discussion:

• Home mechanical ventilation. Under current law, “ventilators” are covered items under the durable medical equipment benefit. In the 1990s, in order to circumvent statutory requirements that ventilators be paid under a “frequent and substantial servicing” payment methodology, HCFA (now CMS) created a new category – respiratory assist devices and declared that these devices, despite classification by FDA as ventilators, are not ventilators in reality, and the payment methodology, therefore, does not apply.

Over the past several years, the pulmonary medicine community tried its best to convince CMS that its rules were problematic, archaic, and costing the Medicare program tens of millions of dollars in unnecessary expenditures. A formal submission to CMS, a request for a National Coverage Determination reconsideration, was denied with a phrase now echoed throughout health care, “it’s complicated.” The only effective solution is a legislative one.

• High flow oxygen therapy for ILD patients. Oxygen remains the largest single component of the durable medical equipment benefit and, largely due to competitive bidding, has seen payment drop dramatically since the implementation of competitive bidding.

One can easily argue that competitive pricing is self-inflicted by the DME industry as the rates are set through a complicated formula based on bids from suppliers. But the impact has been particularly hard on liquid systems, the delivery system choice of not only many Medicare beneficiaries but also is the modality of choice for patients with clear need for high flow oxygen. While delivery in the home for high flow needs can be met by some stationary concentrators, the virtual disappearance of liquid systems, attributable to pricing triggered by competitive bidding, results in many ILD patients unable to leave their homes. The only effective solution is a legislative one.

• Section 603. This provision of the Balanced Budget Act of 2015 was designed to inhibit hospital purchases of certain physician practices that were based on aberrations within the Medicare payment system that rewarded hospitals significantly more than the same service provided in a physician office. For example, a physician office-based sleep lab may be able to bill Medicare for a particular service, but if the hospital purchases that physician practice and bills for the same service, it might receive upwards of twice as much payment.

While all involved seem to agree that this provision was not intended to target pulmonary rehabilitation services, it is being hit particularly hard by CMS rules implementing the statute. Any new pulmonary rehab program that is not within 250 yards of the main hospital campus must bill at the physician fee schedule rate, a rate about half of the hospital outpatient rate. Furthermore, existing programs that choose to expand must do so within the confines of their specific current location, unable to move a floor away. Doing so would trigger the reduced payment methodology.
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CMS agrees this is clearly an example of unintended consequences, but CMS also acknowledges it does not have the authority to remedy the situation. The agency itself signaled the only way to exempt pulmonary rehabilitation services is to seek Congressional action.

And now to the “sausage” part of the equation. Congressional action on virtually anything except renaming a post office becomes a political, as well as substantive, challenge. Here are just some of the considerations that must be addressed by any legislative strategy.
 

1. Any “fix” must be clinically sound and supported across a broad cross section of physician and patient groups. And the fix must give some level of flexibility to CMS to implement it in a reasonable way but tie their hands to force changes in policy.

2. Any “fix” must have a strong political strategy that can muster support within key Congressional committees (House Ways & Means Committee and Energy & Commerce Committee, along with the Senate Finance Committee, let alone 218 votes in the House and 51 votes in the Senate.

Given these issues, almost regardless of the political environment, it is time to begin working on substantive solutions so that when the political climate improves, pulmonary medicine is ready to move forward with a coordinated cohesive strategy.