By instead issuing a national coverage determination (NCD) for CAR T-cell therapies, the additional administrative burden of a CED on providers is prevented, which could have resulted in patient access issues if providers had opted not to provide the therapy to Medicare beneficiaries.
Full Answer
Does Medicare cover CAR T-cell therapy?
Today the Centers for Medicare & Medicaid Services (CMS), under the leadership of President Trump and Secretary Azar, finalized the decision to cover FDA-approved Chimeric Antigen Receptor T-cell, or “CAR T-cell” therapy, which is a form of cancer treatment that uses a patient’s own genetically-modified immune cells to fight disease.
Will Medicare pay for CAR-T treatments?
The Centers for Medicare & Medicaid Services (CMS) finalized its previously proposed changes to how hospital inpatient treatments using chimeric antigen receptor T-cell therapy (CAR-T) products will be reimbursed under Medicare fee-for-service.
What is CAR T-cell therapy and how does it work?
Even after the cancerous cells have been attacked and destroyed, the CAR T cells remain in the body to help prevent cancer reoccurrence, allowing for long-term remission. CAR T-cell therapy can be used by most people with acute lymphoblastic leukemia (ALL) and certain types of non-Hodgkin lymphoma.
What is CAR-T therapy and how does it work?
CAR-T therapy, also known as CAR T-cell therapy, is a cancer treatment that involves modifying a patient’s own immune cells so that they will fight and kill cancer cells and then reinserting them into the body. These cells are taken from the patient’s blood.
Does Medicare Cover CAR T-cell therapy?
Medicare currently pays for therapies like CAR-T at the average sales price plus a margin of 4.3% to cover costs associated with delivering these therapies.
What is the most common toxicity with CAR T-cell therapy?
Cytokine release syndrome (CRS), a systemic inflammatory response caused by cytokines released by infused CAR T cells can lead to widespread reversible organ dysfunction. CRS is the most common type of toxicity caused by CAR T cells.
What are the risks associated with CAR T-cell therapy?
While the therapy can lead to long-lasting remissions for some patients with very advanced cancer, it can also cause neurologic side effects such as speech problems, tremors, delirium, and seizures. Some side effects can be severe or fatal.
Is CAR-T considered cell therapy?
CAR T-cell therapy is used to treat certain blood cancers, and it is being studied in the treatment of other types of cancer. Also called chimeric antigen receptor T-cell therapy.
What is the success rate of CAR T-cell therapy?
The CAR T-cell therapy success rate is about 30% to 40% for lasting remission, with no additional treatment, according to Michael Bishop, MD, director of UChicago Medicine's cellular therapy program.
What cancers does car t treat?
The types of cancer that are currently treated using CAR T-cell therapy are diffuse large B-cell lymphoma (DLBCL), follicular lymphoma, mantle cell lymphoma, multiple myeloma, and B-cell acute lymphoblastic leukemia (ALL) in pediatric and young adult patients up to age 25.
What are the three biggest challenges with manufacturing CAR T cells?
The pivotal challenges in the field of solid tumor CAR T cell therapy can be summarized in three major parts: recognition, trafficking, and surviving in the tumor.
Is CAR T-cell therapy FDA approved?
On February 28, the Food and Drug Administration (FDA) approved ciltacabtagene autoleucel (Carvykti) for adults with multiple myeloma that is not responding to treatment (refractory) or has returned after treatment (relapsed).
Is CAR T-cell therapy a bone marrow transplant?
CAR T-cell infusion occurs on the Northside Hospital Inpatient Blood and Marrow Transplant, Leukemia and Immunotherapy Unit. The infusion process is similar to receiving a blood product infusion.
Is car T cell therapy a last resort?
June estimates that tens of thousands of people have received CAR-T cell treatment. But the therapy is expensive, risky and technically demanding. It remains a last resort, to be used when all other treatments have failed.
Is T cell therapy covered by insurance?
Medicare agreed to cover her treatment. Now more patients are likely to have it covered as well. In August 2019, the Centers for Medicare & Medicaid Services announced that CAR-T cell therapy would be covered for all people with Medicare.
Is CAR-T therapy considered a transplant?
Chimeric antigen receptor (CAR)-T cell therapy, also known as CAR -T cell therapy, was approved by the Food and Drug Administration in October 2017. CAR -T cell therapy is not the same as stem cell transplant or chemotherapy.
Reimbursement still a major issue
But the coverage decision is tempered by a related CMS decision regarding the reimbursement percentage Medicare will provide to hospitals for the costs of CAR-T.
Will some people be left out?
Dr. Dimitrios Tzachanis, an associate clinical professor of medicine at the UC San Diego Moores Cancer Center, said the CMS decision on reimbursement is hopefully just a first step rather than the final say in the matter.
The approved CAR-T therapies
Fata’s clinical trial and others are what led the CAR-T with which he was treated, Yescarta, to be approved by the FDA.
Ongoing clinical trials
There are clinical trials for multiple CAR-T treatments in the United States, China, Europe, and other regions.
Veterans department now pays
When Alan Izumigawa, 51, an Army veteran from Riverside County in California, was diagnosed with DLBCL, he tried chemotherapy.
What type of cancer is a car T cell?
FDA-approved CAR T-cell therapies are approved to treat some people with specific types of cancer – certain types of non-Hodgkin lymphoma and B-cell precursor acute lymphoblastic leukemia.
Does Medicare cover car T cells?
Medicare will cover CAR T-cell therapies when they are provided in healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) for FDA-approved indications (according to the FDA-approved label). In addition, Medicare will cover FDA-approved CAR T-cell therapies for off-label uses that are recommended by CMS-approved ...
When did CMS start coverage analysis for car T cell therapy?
CMS first initiated a national coverage analysis for CAR T-cell therapy for cancers in May 2018 and began considering public comments. In February, CMS posted a proposed decision memo saying it intends to allow Medicare to pay for CAR T.
What is car T cell therapy?
In CAR T-cell therapy, a patient’s white blood cells are extracted and modified with a receptor that drives the cells to seek out the cancer and attack it. The ultimate goal of the therapy is to not only kill existing tumors but provide an internal line of defense against future cancers.
What is a car T cell?
A growing number of drug companies have begun seeking and achieving regulatory approval for chimeric antigen receptor (CAR) T-cell therapy , in which oncologists use a patient’s own immune system to attack certain cancers.
Does Medicare cover car T cells?
Medicare will begin covering the growing collection of immunotherapy drugs referred to as CAR T-cell therapy for cancer patients being treated in some healthcare facilities, the Centers for Medicare & Medicaid Services announced Wednesday. A growing number of drug companies have begun seeking and achieving regulatory approval for chimeric antigen ...
Does Medicare cover outpatient care?
And then any of their outpatient or inpatient care as well.". Medicare will cover the therapies when they are provided in healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) for FDA-approved indications, officials said. In addition, Medicare will cover the FDA-approved therapies for off-label uses ...
How much is a CAR T episode in 2021?
Hospital charges for CAR-T episode are consistent with the average case-weighted charge listed in the FY 2021 IPPS proposed/final rules ($1,237,393 ). Clinical trial charges are assumed to be 15% of non-clinical trial charges for the proposed rule and 17% of charges for the final rule.
Does total reimbursement vary by hospital?
Total reimbursement will vary by hospital and case, with adequate reimbursement in some cases but with potential risk for hospitals on significantly costly cases, especially if the CMS doesn’t appropriately account for a hospital’s costs to treat a patient with CAR-T.
Is Car T a precedent?
Policy changes to Medicare’s CAR-T inpatient reimbursement set a precedent for high-cost durable treatments. Looking ahead, questions and concerns remain for pipeline cell and gene therapies that have high up-front costs.
What is the CPT code for Car T?
In instances when you administer the CAR-T drug in the hospital outpatient setting, report CPT code 0540T for the administration and HCPCS Q-code Q2041 or Q2042 for the drug/biological. As discussed in the CY 2019 OPPS/ASC final rule (83 FR 58904), the procedures described by CPT codes 0537T (collection/handling), 0538T (preparation for transport), and 0539T (receipt and preparation) represent the various steps required to collect and prepare the genetically modified T-cells, and these steps are not paid separately under the OPPS.
What is car T cell therapy?
CAR T-cell therapy is a cell-based gene therapy in which T-cells are collected and genetically engineered to express a chimeric antigen receptor that binds to a certain protein on a patient’s cancerous cells. The CAR T-cells are then administered to the beneficiary to attack certain cancerous cells and the individual is observed for potential serious side effects that require medical intervention if present.
Can a hospital report a car T drug Q code?
In instances when the CAR-T drug is not ultimately administered to the beneficiary, but the CAR-T preparation services are initiated or performed in the HOPD facility, the hospital may not report the drug Q-code (which only applies when the T-cells are administered in the HOPD setting). HOPDs may report CPT codes 0537T, 0538T, and 0539T (as appropriate) and the charges associated with each code under the appropriate revenue code on the HOPD claim. Medicare will reject these codes.