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Addressing issues related to step therapy and adapting the Stark Law for a value-based care environment are on the Department of Health & Human Service’s agenda this year, according to agency Secretary Alex M. Azar II.

Gregory Twachtman/MDedge News
HHS Secretary Alex Azar speaking at the AMA National Advocacy Conference, Feb. 12, 2019.

Speaking Feb. 12 at the American Medical Association’s National Advocacy Conference, Secretary Azar said the agency will be looking into ensuring that patients on medical plans who have found a working drug after going through a step-therapy protocol will not have to restart on a drug that has already failed for them if they switch insurance providers.

“I was very disturbed to hear that stable patients switching among insurance plans, like switching among Medicare Advantage plans, can often be required to start over again on a step therapy regimen,” he said.

“This is not just potentially injurious to their health, it’s also penny-wise and pound-foolish,” Secretary Azar continued. “We know that getting a patient on the right drug, at the right time, is one of the best investments we can make in their health, and we do not want to impede physicians from making that happen. We’re looking at how we can address that issue now.”

The other area Secretary Azar highlighted that the agency is working on is making changes to the Stark Law.

 

 


“The Stark Law was written with noble purposes in mind, but it was designed for a fee-for-service system, not the kind of system we are moving toward today,” he said. “We’ve heard from many, many stakeholders, including the AMA, about the need to update the enumerated exceptions in the Stark Law to include value-based approaches to care.”

He added that how care coordination interacts with the antikickback statutes and HIPAA are also going to be examined.

He used most of his speech to discuss recent regulatory actions around drug pricing and pushed for support for the Part B drug pricing model that the agency is preparing for a formal proposed rule, despite having received a critical reception from medical societies.

“If you have a small practice that uses infusions, and you don’t want to bear the risk of buy and bill, now you’re off the hook,” he said. “We’ll allow you to work with private vendors who can take the risk for buying the drugs in a way that isn’t possible today. But if you’re part of a much larger practice that’s able to drive a better deal than you could on your own, or want to band together with other practices to do the purchasing, then you can do that, too.”

He continued: “Next is the launch of the actual proposed rule, followed by the rule itself, which, I’ll remind you, is just a model.”

However, despite it being a model under test from the Center for Medicare & Medicaid Innovation, the advanced notice of proposed rule making that was issued in October 2018 suggested that participation in the so-called International Pricing Index model would be mandatory.

AGA is pleased about Secretary Azar’s commitment to ensuring Medicare beneficiaries will continue to have access to and coverage of medications that work for them. Patients should not be forced to switch to a therapy that they have already failed if they change insurance plans. Read more about AGA’s advocacy for similar federal legislation at http://ow.ly/2t3030nLbcB.

AGA, in conjunction with other physician specialty organizations, continues to advocate for changes in the Stark Law to allow physician practices to participate in advanced payment models in the Medicare program that will improve care coordination and patient outcomes.

gtwachtman@mdedge.com

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Addressing issues related to step therapy and adapting the Stark Law for a value-based care environment are on the Department of Health & Human Service’s agenda this year, according to agency Secretary Alex M. Azar II.

Gregory Twachtman/MDedge News
HHS Secretary Alex Azar speaking at the AMA National Advocacy Conference, Feb. 12, 2019.

Speaking Feb. 12 at the American Medical Association’s National Advocacy Conference, Secretary Azar said the agency will be looking into ensuring that patients on medical plans who have found a working drug after going through a step-therapy protocol will not have to restart on a drug that has already failed for them if they switch insurance providers.

“I was very disturbed to hear that stable patients switching among insurance plans, like switching among Medicare Advantage plans, can often be required to start over again on a step therapy regimen,” he said.

“This is not just potentially injurious to their health, it’s also penny-wise and pound-foolish,” Secretary Azar continued. “We know that getting a patient on the right drug, at the right time, is one of the best investments we can make in their health, and we do not want to impede physicians from making that happen. We’re looking at how we can address that issue now.”

The other area Secretary Azar highlighted that the agency is working on is making changes to the Stark Law.

 

 


“The Stark Law was written with noble purposes in mind, but it was designed for a fee-for-service system, not the kind of system we are moving toward today,” he said. “We’ve heard from many, many stakeholders, including the AMA, about the need to update the enumerated exceptions in the Stark Law to include value-based approaches to care.”

He added that how care coordination interacts with the antikickback statutes and HIPAA are also going to be examined.

He used most of his speech to discuss recent regulatory actions around drug pricing and pushed for support for the Part B drug pricing model that the agency is preparing for a formal proposed rule, despite having received a critical reception from medical societies.

“If you have a small practice that uses infusions, and you don’t want to bear the risk of buy and bill, now you’re off the hook,” he said. “We’ll allow you to work with private vendors who can take the risk for buying the drugs in a way that isn’t possible today. But if you’re part of a much larger practice that’s able to drive a better deal than you could on your own, or want to band together with other practices to do the purchasing, then you can do that, too.”

He continued: “Next is the launch of the actual proposed rule, followed by the rule itself, which, I’ll remind you, is just a model.”

However, despite it being a model under test from the Center for Medicare & Medicaid Innovation, the advanced notice of proposed rule making that was issued in October 2018 suggested that participation in the so-called International Pricing Index model would be mandatory.

AGA is pleased about Secretary Azar’s commitment to ensuring Medicare beneficiaries will continue to have access to and coverage of medications that work for them. Patients should not be forced to switch to a therapy that they have already failed if they change insurance plans. Read more about AGA’s advocacy for similar federal legislation at http://ow.ly/2t3030nLbcB.

AGA, in conjunction with other physician specialty organizations, continues to advocate for changes in the Stark Law to allow physician practices to participate in advanced payment models in the Medicare program that will improve care coordination and patient outcomes.

gtwachtman@mdedge.com

Addressing issues related to step therapy and adapting the Stark Law for a value-based care environment are on the Department of Health & Human Service’s agenda this year, according to agency Secretary Alex M. Azar II.

Gregory Twachtman/MDedge News
HHS Secretary Alex Azar speaking at the AMA National Advocacy Conference, Feb. 12, 2019.

Speaking Feb. 12 at the American Medical Association’s National Advocacy Conference, Secretary Azar said the agency will be looking into ensuring that patients on medical plans who have found a working drug after going through a step-therapy protocol will not have to restart on a drug that has already failed for them if they switch insurance providers.

“I was very disturbed to hear that stable patients switching among insurance plans, like switching among Medicare Advantage plans, can often be required to start over again on a step therapy regimen,” he said.

“This is not just potentially injurious to their health, it’s also penny-wise and pound-foolish,” Secretary Azar continued. “We know that getting a patient on the right drug, at the right time, is one of the best investments we can make in their health, and we do not want to impede physicians from making that happen. We’re looking at how we can address that issue now.”

The other area Secretary Azar highlighted that the agency is working on is making changes to the Stark Law.

 

 


“The Stark Law was written with noble purposes in mind, but it was designed for a fee-for-service system, not the kind of system we are moving toward today,” he said. “We’ve heard from many, many stakeholders, including the AMA, about the need to update the enumerated exceptions in the Stark Law to include value-based approaches to care.”

He added that how care coordination interacts with the antikickback statutes and HIPAA are also going to be examined.

He used most of his speech to discuss recent regulatory actions around drug pricing and pushed for support for the Part B drug pricing model that the agency is preparing for a formal proposed rule, despite having received a critical reception from medical societies.

“If you have a small practice that uses infusions, and you don’t want to bear the risk of buy and bill, now you’re off the hook,” he said. “We’ll allow you to work with private vendors who can take the risk for buying the drugs in a way that isn’t possible today. But if you’re part of a much larger practice that’s able to drive a better deal than you could on your own, or want to band together with other practices to do the purchasing, then you can do that, too.”

He continued: “Next is the launch of the actual proposed rule, followed by the rule itself, which, I’ll remind you, is just a model.”

However, despite it being a model under test from the Center for Medicare & Medicaid Innovation, the advanced notice of proposed rule making that was issued in October 2018 suggested that participation in the so-called International Pricing Index model would be mandatory.

AGA is pleased about Secretary Azar’s commitment to ensuring Medicare beneficiaries will continue to have access to and coverage of medications that work for them. Patients should not be forced to switch to a therapy that they have already failed if they change insurance plans. Read more about AGA’s advocacy for similar federal legislation at http://ow.ly/2t3030nLbcB.

AGA, in conjunction with other physician specialty organizations, continues to advocate for changes in the Stark Law to allow physician practices to participate in advanced payment models in the Medicare program that will improve care coordination and patient outcomes.

gtwachtman@mdedge.com

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