ASN and Partnership for Medicare Part D Access Prevail in Fight to Preserve Six Protected Classes

By David White

After strenuous objection from the American Society of Nephrology (ASN) and its fellow coalition members in the Partnership for Part D Access, the Centers for Medicare & Medicaid Services (CMS) issued a final rule on May 16, 2019, on Medicare Part D prescription drugs that dropped an earlier CMS proposal that would have undermined current protections for the six protected classes of drugs. The final rule maintains protections for these classes: 1) antidepressants; 2) antipsychotics; 3) anticonvulsants; 4) immunosuppressants for treatment of transplant rejection; 5) antiretrovirals; and 6) antineoplastics. ASN Policy wrote about an administration proposal to alter the status of the six classes earlier this year in KNO when ASN submitted comments to Medicare on its Medicare Advantage and Part D Drug Pricing Proposed Rule on January 25.

ASN and its Partnership partners strongly objected to segments of the proposed rule that would have removed protections from the “six protected classes of drugs” in Medicare Part D. Specifically, ASN objected to the proposal to implement broader use of prior authorization and step therapy for protected class drugs, including to determine use for protected class indications.

“Immunosuppression medications are not interchangeable and limiting options for immunosuppression will likely negatively impact patient outcomes. Not all patients tolerate immunosuppressive drugs, even if listed within the same class, in the same way. Their therapeutic benefits and adverse effects can vary significantly from patient to patient. Physicians often must adjust therapeutic regimens to address their patient-to patient variability,” wrote ASN President Mark E. Rosenberg, MD, FASN in a letter to CMS Administration Seema Verma.  “For some patients, especially children who are unable to take tablets or capsules, liquid formulations of immunosuppressive drugs must be prescribed. Limiting immunosuppressive options can also negatively impact transplant recipients doing well on a particular immunosuppressive regime. Altering their drugs as a result of the proposed rule could result in reduced efficacy or intolerable side effects and result in allograft rejection.”

Dr. Rosenberg continued “[t]herefore, to guarantee optimal treatment and preserve the gift of life for kidney transplant patients, physicians need to have all FDA approved immunosuppressive drugs at their disposal. The society strongly believes that decisions about this complicated drug regimen should be left to a physician and their patient, and not limited or constrained by payment policies.”

This isn't the first time that the federal government has backed off wholesale changes to protected drug classes. In 2014, the Obama administration sought to remove antidepressants, immunosuppressants and antipsychotics as protected classes but the changes were scrapped.

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After strenuous objection from the American Society of Nephrology (ASN) and its fellow coalition members in the Partnership for Part D Access, the Centers for Medicare & Medicaid Services (CMS) issued a final rule on May 16, 2019, on Medicare Part D prescription drugs that dropped an earlier CMS proposal that would have undermined current protections for the six protected classes of drugs. The final rule maintains protections for these classes: 1) antidepressants; 2) antipsychotics; 3) anticonvulsants; 4) immunosuppressants for treatment of transplant rejection; 5) antiretrovirals; and 6) antineoplastics. ASN Policy wrote about an administration proposal to alter the status of the six classes earlier this year in KNO when ASN submitted comments to Medicare on its Medicare Advantage and Part D Drug Pricing Proposed Rule on January 25.

ASN and its Partnership partners strongly objected to segments of the proposed rule that would have removed protections from the “six protected classes of drugs” in Medicare Part D. Specifically, ASN objected to the proposal to implement broader use of prior authorization and step therapy for protected class drugs, including to determine use for protected class indications.

“Immunosuppression medications are not interchangeable and limiting options for immunosuppression will likely negatively impact patient outcomes. Not all patients tolerate immunosuppressive drugs, even if listed within the same class, in the same way. Their therapeutic benefits and adverse effects can vary significantly from patient to patient. Physicians often must adjust therapeutic regimens to address their patient-to patient variability,” wrote ASN President Mark E. Rosenberg, MD, FASN in a letter to CMS Administration Seema Verma.  “For some patients, especially children who are unable to take tablets or capsules, liquid formulations of immunosuppressive drugs must be prescribed. Limiting immunosuppressive options can also negatively impact transplant recipients doing well on a particular immunosuppressive regime. Altering their drugs as a result of the proposed rule could result in reduced efficacy or intolerable side effects and result in allograft rejection.”

Dr. Rosenberg continued “[t]herefore, to guarantee optimal treatment and preserve the gift of life for kidney transplant patients, physicians need to have all FDA approved immunosuppressive drugs at their disposal. The society strongly believes that decisions about this complicated drug regimen should be left to a physician and their patient, and not limited or constrained by payment policies.”

This isn't the first time that the federal government has backed off wholesale changes to protected drug classes. In 2014, the Obama administration sought to remove antidepressants, immunosuppressants and antipsychotics as protected classes but the changes were scrapped.

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Tuesday, May 21, 2019