On Wednesday July 10, 2024, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule that includes its decision regarding Medicare coverage for autoimmune disease patients on immunosuppressive therapy (on page 435). The nomination, led by the Sjögren’s Foundation, argued that certain dental services are inextricably linked to immunosuppressive therapies for individuals with autoimmune disorders.
Unfortunately, despite two years of fighting for Sjögren’s and autoimmune disease patients to obtain access to dental coverage under Medicare, CMS did not move forward with our nomination. Instead, CMS is seeking further information regarding this inextricable link. This setback is obviously disappointing, but we feel that CMS has provided feedback that offers a way forward to continue our pursuit for Medicare dental coverage for this population of Medicare beneficiaries with an autoimmune disease.
Specifically, CMS agrees that research should continue into whether there is a connection between dental and oral evaluations and treatment prior to immunosuppressive therapy and outcomes for such therapies. CMS also seeks comment on whether the level of immunosuppression utilized in the treatment of autoimmune diseases is similar to the immunosuppression levels employed in the treatment of cancer. CMS previously finalized payment for dental exams for certain cancers and chemotherapy.
CMS is also seeking information on the connection between immunosuppressive therapy in the treatment of autoimmune disease and the likelihood of systemic infection and sepsis. In our nomination, we noted that CMS stated that proceeding without a dental or oral exam of the mouth prior to chemotherapy could lead to systemic infection or sepsis, among other complications, and similar outcomes can follow for those receiving immunosuppressive therapy to treat autoimmune diseases.
Lastly, CMS is seeking information regarding standards of care or clinical guidelines that recommend that a dental infection be addressed before proceeding with the immunosuppressive treatment. This could be an area where we could demonstrate certain immunosuppressive therapies pose relatively higher risks to patients, but further research is necessary.
We have two months from the rules publication date to provide comments and will continue to review the rule and determine next steps in the coming days and weeks.
Background
The Sjögren’s Foundation led the charge for Medicare coverage of medically necessary dental treatment for Sjögren’s and other autoimmune disease patients in 2023 and again this year. The Centers for Medicare and Medicaid Services (CMS) first opened the door for potential coverage in the fall of 2022 allowing for nominations of diseases and conditions for whom dental exams were inextricably link to the success of the covered treatment, and the Foundation jumped on the opportunity to apply by the February 2023 deadline.
CMS declined to cover dental services for Sjögren’s and other autoimmune diseases last year despite our documented need and presentation before CMS that demonstrated a clear systemic-oral link, with oral issues directly caused by a systemic disease and leading to systemic complications and autoimmune disease exacerbation. For information on the first CMS ruling, you can learn more here.
CMS subsequently clarified its mandate for nominees, and this year, we followed their lead and narrowed the scope of coverage for Medicare to consider those autoimmune disease patients on immunosuppressant therapy. CMS also mandated that requests cite precise circumstances in which dental services are linked to a specific Medicare-covered service instead of a diagnosis. Since CMS approved the coverage of certain dental services for cancer patients undergoing chemotherapy, we argued there is a similar need for autoimmune disease patients undergoing immunosuppressant therapy.
Never give up!
The Foundation submitted its new proposal in February of this year and attained the full and active support of other autoimmune disease patient organizations, so we had as many voices as possible behind our request.
Our hard work before and since then has involved engaging in fruitful dialogue with key opinion leaders as well as with CMS to build recognition of the need for dental services for Sjögren’s and other autoimmune disease patients and strategize about paths forward to ensure this happens. We collaborated with the Oral Health Coalition (oralhealthconsortium.org) to garner a wide range of critical support and met with the coalition and many federal agencies and offices. We also met independently with legislators on Capitol Hill, provided written Congressional testimony for two years on the issue, and obtained lead support from U.S. Representative Joseph D. Morelle who circulated a letter on patient needs among Congressional colleagues.
We are proud of our work to-date and will not give up the fight as we gauge the next best steps to ensure all patients get the coverage they need!
CMS Publishes Decision on Medicare Coverage Nomination for Autoimmune Disease Patients on Immunosuppressive Therapy
On Wednesday July 10, 2024, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule that includes its decision regarding Medicare coverage for autoimmune disease patients on immunosuppressive therapy (on page 435). The nomination, led by the Sjögren’s Foundation, argued that certain dental services are inextricably linked to immunosuppressive therapies for individuals with autoimmune disorders.
Unfortunately, despite two years of fighting for Sjögren’s and autoimmune disease patients to obtain access to dental coverage under Medicare, CMS did not move forward with our nomination. Instead, CMS is seeking further information regarding this inextricable link. This setback is obviously disappointing, but we feel that CMS has provided feedback that offers a way forward to continue our pursuit for Medicare dental coverage for this population of Medicare beneficiaries with an autoimmune disease.
Specifically, CMS agrees that research should continue into whether there is a connection between dental and oral evaluations and treatment prior to immunosuppressive therapy and outcomes for such therapies. CMS also seeks comment on whether the level of immunosuppression utilized in the treatment of autoimmune diseases is similar to the immunosuppression levels employed in the treatment of cancer. CMS previously finalized payment for dental exams for certain cancers and chemotherapy.
CMS is also seeking information on the connection between immunosuppressive therapy in the treatment of autoimmune disease and the likelihood of systemic infection and sepsis. In our nomination, we noted that CMS stated that proceeding without a dental or oral exam of the mouth prior to chemotherapy could lead to systemic infection or sepsis, among other complications, and similar outcomes can follow for those receiving immunosuppressive therapy to treat autoimmune diseases.
Lastly, CMS is seeking information regarding standards of care or clinical guidelines that recommend that a dental infection be addressed before proceeding with the immunosuppressive treatment. This could be an area where we could demonstrate certain immunosuppressive therapies pose relatively higher risks to patients, but further research is necessary.
We have two months from the rules publication date to provide comments and will continue to review the rule and determine next steps in the coming days and weeks.
Background
The Sjögren’s Foundation led the charge for Medicare coverage of medically necessary dental treatment for Sjögren’s and other autoimmune disease patients in 2023 and again this year. The Centers for Medicare and Medicaid Services (CMS) first opened the door for potential coverage in the fall of 2022 allowing for nominations of diseases and conditions for whom dental exams were inextricably link to the success of the covered treatment, and the Foundation jumped on the opportunity to apply by the February 2023 deadline.
CMS declined to cover dental services for Sjögren’s and other autoimmune diseases last year despite our documented need and presentation before CMS that demonstrated a clear systemic-oral link, with oral issues directly caused by a systemic disease and leading to systemic complications and autoimmune disease exacerbation. For information on the first CMS ruling, you can learn more here.
CMS subsequently clarified its mandate for nominees, and this year, we followed their lead and narrowed the scope of coverage for Medicare to consider those autoimmune disease patients on immunosuppressant therapy. CMS also mandated that requests cite precise circumstances in which dental services are linked to a specific Medicare-covered service instead of a diagnosis. Since CMS approved the coverage of certain dental services for cancer patients undergoing chemotherapy, we argued there is a similar need for autoimmune disease patients undergoing immunosuppressant therapy.
Never give up!
The Foundation submitted its new proposal in February of this year and attained the full and active support of other autoimmune disease patient organizations, so we had as many voices as possible behind our request.
Our hard work before and since then has involved engaging in fruitful dialogue with key opinion leaders as well as with CMS to build recognition of the need for dental services for Sjögren’s and other autoimmune disease patients and strategize about paths forward to ensure this happens. We collaborated with the Oral Health Coalition (oralhealthconsortium.org) to garner a wide range of critical support and met with the coalition and many federal agencies and offices. We also met independently with legislators on Capitol Hill, provided written Congressional testimony for two years on the issue, and obtained lead support from U.S. Representative Joseph D. Morelle who circulated a letter on patient needs among Congressional colleagues.
We are proud of our work to-date and will not give up the fight as we gauge the next best steps to ensure all patients get the coverage they need!