On April 23, the Centers for Medicare & Medicaid (CMS) released the FY2020 Inpatient Prospective Payment System (IPPS) proposed rule. The IPPS rule addresses ways to improve payment for CAR-T therapies and is a step in the right direction. The American Society for Transplantation and Cellular Therapy (ASTCT) has been working closely with CMS to improve reimbursement for chimeric antigen receptor T-cell (CAR-T) therapy to ensure appropriate patient access to this lifesaving therapy and will continue to work with the agency on this important issue.
In the proposed rule, CMS indicates that the agency should collect more clinical data prior to creating a new MS-DRG for these therapies. ASTCT along with other stakeholder groups agree with CMS that there is not enough clinical data yet available for CMS to create a new MS-DRG; ASTCT supports keeping the MS-DRG 016 “Autologous Bone Marrow Transplant with CC/MCC or T-cell Immunotherapy” for FY2020 in the interim while CMS collects further data as more claims become available.
However, ASTCT will weigh in and let the agency know that while we agree it is premature for a new DRG, that when CMS is prepared to create a new DRG in the future, when developing the relative weight they should not include clinical trial cases in the calculation of the DRG because the inclusion of those cases will disproportionately represent the costs associated with delivery of these therapies.
CMS has found that the costs have varied widely for these therapies because of the differences in billing and charging practices and because of the limited number of cases. ASTCT has engaged with CMS on the billing and coding issues when ASTCT attended the April 9th NUBC meeting in Baltimore and continues to engage with the agency to sort through the confusion.
In the proposed rule CMS also seeks comment on a payment alternative for CAR-T cases that would include eliminating the CCR in calculating the new technology add-on payment (NTAP) for the two currently approved FDA therapies by making a uniform add-on payment that equals the proposed maximum add-on payment that is 65 percent of the cost of the technology. While ASTCT is encouraged by the suggestion of a new uniform NTAP, we believe that the 65 percent is not an adequate maximum NTAP amount. ASTCT will respond in comments and let CMS know that we are interested the uniform NTAP payment but at 80 percent of the cost of the technology so there is some relief to institutions. ASTCT is remaining consistent with previous comments sent to the agency.
CMS proposed to continue the NTAP through FY2020, which ASTCT is supportive of, while CMS collects further data for these cases. Additionally, CMS requests comment on alternative payment models, improving payment for PPS-exempt centers, and implementation of a CCR of 1.0. ASTCT is continuing to sort through the proposals and requests for comments and will respond to CMS by the comment due date of June 24. ASTCT will release their comments publicly on ASTCT’s website. The proposed rule can be viewed here. CMS’ press release on the proposed rule can be found here.
ASTCT Hill Day 2019
On May 21 and 22, the Government Relations Committee participated in Hill Day 2019, where members met with nearly 50 Congressional offices over two days. During the Hill Day, ASTCT participants educated Members of Congress and their staff on the importance of supporting these new innovative therapies and to support our efforts with CMS. Government Relations Committee members observed Congressional committee hearings, met with Members of Congress and their staff, attended a Hill briefing sponsored by Representative Higgins, and traveled around the Nation’s Capital.
In the meetings, ASTCT asked Congress to support the society’s comments on the IPPS proposed rule by urging CMS to continue the NTAP payment for CAR-T therapies through FY2020 and to institute a uniform NTAP at 80 percent of the product cost. Additionally, ASTCT sought co-sponsorship for the recently introduced PACT Act (H.R. 2498/S. 1268) legislation, which ensures that hospitals receive adequate Medicare payment for the acquisition of hematopoietic stem cells. The PACT Act is a bipartisan, bicameral bill that will greatly help relieve some of the financial burden on our institutions delivering these transplant therapies. The text of the legislation can be found here. ASTCT’s one pagers on both the PACT Act and the IPPS proposed rule can be found here and here, respectively. For more information and pictures from the day please check out ASTCT’s Twitter feed here.
National Coverage Analysis Decision Delay
On February 15, 2019, CMS released a proposed decision memo to cover autologous treatment with T-cells expressing at least one chimeric antigen receptor (CAR) through coverage with evidence development (CED) when prescribed by the treating oncologist, performed in a hospital, and if the patient has relapsed or refractory cancer. The proposed decision memo can be found here. ASTCT submitted public comments on our opposition to the NCD and explained the concerns we had with releasing one prematurely. ASTCT’s comments can be found in the Public Register here.
CMS was set to release the final decision on May 17, however, they released the following statement: “CMS will not be issuing a final National Coverage Determination on CAR T-cell therapy for cancer today, but a decision is forthcoming.”
Stay tuned for further updates on the final decision.
ICYMI
Seema Verma Says CMS Taking Care to Get CAR-T Coverage Decision Right- Inside Health Policy published an article on May 22 that gets insight into the delayed NCD decision. Verma explains that the agency is taking the time to get the Medicare coverage policy for new expensive hospital-administered cancer drugs right. She said, “It’s not only new technology for the entire medical community, cancer care, but it’s also new ground for the agency.” ASTCT will continue to monitor for the final decision.
Senate Takes Measures to Lower Health Care Costs through Sweeping Legislation- According to The Hill reporting, the U.S. Senate has drafted a bipartisan piece of legislation that address issues like surprise medical billing, drug prices, maternal mortality, and vaccine hesitancy. The goal is to have the package on the Senate floor by this summer.
Medicare for All Losing Steam? – On Kaiser Health News’ podcast What the Health this week the hosts address the Medicare for All proposals that have been addressed in two separate House hearings. The episode dives into the dramatic overhaul of the nation’s health care system and how the excitement surrounding it seems to be dying down on Capitol Hill.