On August 2, the Centers for Medicare & Medicaid (CMS) released the FY2020 Inpatient Prospective Payment System (IPPS) final rule that includes payment policy for chimeric antigen receptor T-cell (CAR-T) therapy. The American Society for Transplantation and Cellular Therapy (ASTCT) has been working closely with CMS to improve reimbursement for CAR-T therapy and the data the agency collects on its delivery to assure appropriate patient access to this lifesaving therapy. Despite our advocacy efforts, ASTCT is disappointed in the agency’s final payment policy as it did not significantly improve the payment policy for FY 2020 nor did it position the agency to implement an equitable, long-term reimbursement policy for this innovative therapy.
CMS finalized a change to the New Technology Add-On Payment (NTAP) formula increasing its cap from 50 percent to 65 percent for all NTAPs. Centers now may be able to receive an NTAP payment in the amount of $242,500 for CAR-T therapy depending on their total covered billed charges. We are very disappointed CMS did not change the existing “lesser of” portion of the NTAP formula; this means providers will have to continue setting charges in such a manner to receive the maximum NTAP payment available. The agency declined to implement the policies ASTCT suggested that would allow all centers to receive the maximum NTAP regardless of their charging practices and for the agency to collect accurate data on the actual product acquisition cost that would be used to develop a sustainable payment policy when the NTAP is no longer available in FY 2021.
ASTCT has been encouraged by the agency’s continued engagement about our concerns with CAR-T reimbursement and their interest in addressing specific policies for this therapy. The Society appreciates the improvement in the NTAP policy, but this does not go far enough to protect patient access to CAR-T therapy or address the significant concerns of the members and the centers where they practice. ASTCT recognizes many centers have already made the decision to not have a CAR-T program at their institution due to inadequate Medicare payment.
At ASTCT we support our patients and their access to potentially lifesaving treatment. We will continue to work to improve payment policies for CAR-T therapy working both with CMS and our champions on Capitol Hill. Please watch for future communications regarding the Society’s advocacy on this topic to improve and protect patient access.
CMS Final NCD on CAR-T
On August 7, 2019 The Centers for Medicare and Medicaid Services (CMS) released its final decision memo for chimeric antigen receptor (CAR) T-cell therapy for cancers. The final decision memo can be found here. ASTCT was very pleased with the announcement from the agency that the NCD would be finalized and would cover CAR-T therapies. ASTCT worked closely with CMS on the proposed decision memo and asked that the agency eliminate the requirement for coverage with evidence development (CED) as it would create significant barriers to providing these therapies. The agency eliminate the CED requirement for coverage and encourages centers to submit data to registries such as the Center for International Blood and Marrow Transplantation Research (CIBMTR). ASTCT will continue to encourage CMS to make data reporting mandatory so that CMS can collect the most accurate and efficient data for CAR-T. ASTCT is encouraged by this step forward from the agency, however, the Society remains deeply concerned about the reimbursement challenges for these therapies. ASTCT will continue to work with the agency and emphasize the importance of adequate reimbursement. Please find ASTCT’s President’s letter to CMS on the NCD final decision here.
HOPPS Proposed Rule/ Advisory Panel
On July 29, 2019 CMS released the CY2020 Medicare Hospital Outpatient Prospective Payment System (HOPPS) proposed rule. The proposed rule follows the directives from the Presidential Executive Order (EO) entitled “Improving Price and Quality Transparency in American Healthcare to Put Patients First.” According to CMS’ press release the EO, “lay[s] the foundation for a patient-driven healthcare system by making prices for items and services provided by all hospitals in the United States more transparent for patients so that they can be more informed about what they might pay for hospital items and services.” CMS proposes price transparency changes through defining words such as “hospital”, “standard charges”, and “items and services” more clearly. Additionally there will be requirements for hospitals to make public a machine-readable file online that includes all standard charges for all hospital items and services. There are several additional price transparency proposals that can be found in the rule.
The proposed rule not only focuses on price transparency but also on site neutrality, wage index disparities, level of supervision for outpatient services (from direct supervision to general supervision), 340B payment methodologies, and revisions to the organ procurement organization conditions for certification.
For CAR-T therapies, CMS continues to believe that the costs for cell collection and cell processing (hospital outpatient department services) are included in the payment for the product Q-codes. Neither manufacturers nor hospitals pay for these services, therefore the reported ASPs for CAR-T therapies do not include dollars for these services. Neither is CMS currently separately paying for these services by continuing to assign status indicator “B” to the CPT codes for CAR-T, resulting in a rejection of the services because CMS cannot recognize the charges in its APC rate-setting system. ASTCT has engaged the agency on this issue and will include this in the comment letter due September 27th.
ASTCT attended the Advisory Panel on Hospital Outpatient Payment (HOP Panel) on August 19, 2019. ASTCT presented its findings in relation to separate payments for hospital services furnished for CAR-T and put forth a request to the panel for recommendation to CMS. ASTCT sited that CMS provides separate payment for other autologous cellular services for other collection/harvesting CPT codes. Additionally, in the CY 2020 OPPS Proposed Rule, CMS proposes a separate conditional payment for a new Category III CPT code which also involved collection and harvesting of cells in the form of tissue. Ultimately, ASTCT requested that the HOP Panel recommend to CMS that the agency change status indicator “B” assigned to CAR-T Category III CPT codes for cell collection and processing services to a payable indicator and that the status indicator “B” should change to “Q1” similar to the other new CPT code for cell collection. The HOP Panel accepted the Society’s request and made the recommendation to CMS. ASTCT will continue to monitor the progress of this coding and payment issue.
Physician Fee Schedule
On July 29, 2019 CMS released the CY 2020 Physician Fee Schedule proposed rule. This proposed rule updates payment policies, payment rates, and other provisions for services furnished under the Medicare Physician Fee Schedule (PFS) on or after Jan. 1, 2020. According to CMS’ press release on the proposed rule, “…the agency’s proposals are aimed at reducing burden, recognizing clinicians for the time they spend with patients, removing unnecessary measures and making it easier for them to be on the path towards value-based care.” This proposed rule includes a number of new proposals, including a proposal to align the E/M coding and payment with changes recommended by the CPT Editorial Panel and AMA RUC for office/outpatient E/M visits.
Of note, CMS estimates the specialty level impact of these E/M changes should they be implemented in CY 2021 with Hematology/Oncology expected to see a 12 percent increase in E/M reimbursement. CMS proposes to retain separate payment for the individual E/M services as revised by the CPT Editorial Panel. This includes the elimination of CPT code 99201. CMS proposes to adopt all of the RUC-recommended work RVUs and times for the revised code family and new prolonged add-on code that were based on a survey of over 50 specialty societies. CMS believes these values more accurately account for the time and intensity of these services than the policy finalized in last year’s rule.
CMS is also proposing to implement the documentation requirements that were included in the CPT Editorial Panel’s revisions to the code set in 2021. They allow physicians to select a code level based on time or medical decision-making and eliminate the history and physical exam as required elements to select a code level. Documentation of these elements must be specific to each code level. Detailed information about these requirements can be found here.
CMS proposes to pay separately for prolonged outpatient E/M services using the new CPT add-on code 99XXX and delete GPRO1 that had been finalized last year for such services. CMS proposes that this code only be available when physicians choose to document based on time and the time for a level 5 visit is exceeded by 15 minutes or more on the date of service. This service could be billed multiple times for each additional 15-minute increment beyond the level 5 visit time. The agency proposed to adopt the RUC-recommended work RVU for this service.
Additionally, CMS does not believe that the revised code set adequately describes or reflects the resources required for primary care and certain types of specialty care and continues to believe there is a need to capture these additional resource costs with an add-on code. Last year CMS finalized a policy to create two add-on codes, one for primary care and another for types of complex specialty care. In this rule, the agency is proposing to consolidate two services into a single add-on code with a revised descriptor to better describe the work associated with ongoing, comprehensive primary care and/or visits that are part of ongoing care related to a patient’s single, serious, or complex chronic condition. CMS is proposing a work RVU of 0.33 and physician time of 11 minutes. The agency proposes to allow the code to be billed with any level outpatient E/M service. The agency requests comments on these proposed changes including the revised code descriptor and whether or not more than one add-on code would be necessary.
CMS also put forth other proposals that include: care management services, reimbursement for e-Visits, supervision of physician assistants, review of medical record documentation, and coinsurance for colorectal cancer screening.
ASTCT will respond to the CY 2020 proposed PFS rule by the September 27 deadline. More information on the proposed rule can be found here and here.
Year End Priorities for 116th Congress
Both chambers of Congress have been out of session during the August district work period. The 116th Congress will resume on September 9, 2019. We can expect to see a lot of movement from Capitol Hill this fall as there are many priorities that need to move.
Prior to the August recess, on July 25 the House passed the budget caps measure which provides an additional 4324 billion to be added to the spending caps over the next two years. The Senate passed the bill prior to the summer recess. We can expect to see upon the Senate’s return, the Senate Appropriations Committee to consider the FY 2020 spending bills. Congress will have to pass a continuing resolution to fund the government when the FY 2020 begins on October 1, because the Senate has not finalized nor passed its spending bills. More information on the spending caps deal can be found here.
There will be a lot of discussion on Capitol Hill surrounding drug pricing legislation. On July 25, the Senate Finance Committee held a markup on The Prescription Drug Pricing Reduction ACT of 2019 (PDPRA) and passed the bill out of committee. The text of the bill can be found here. PDPRA aims to modernize and improve Medicare Parts B and D. According to the Congressional Budget Office (CBO), taxpayers will save $85 billion in Medicare through the combination of the Part D redesign and the inflation-rebate policies that would save $85 billion over a 10 year period. Provisions in the bill include: simplifying Part D’s program design and capping beneficiary out-of-pocket for high costs; increasing transparency into pharmacy benefit manager (PBM) practices and manufacturer drug pricing decisions; and eliminating excess Part B drug payments that drive up program costs. ASTCT will be paying close attention to the conversation as it unfolds and will give updates as the legislation moves through the chambers.
Additionally, we can also expect to see surprise billing legislation movement again this fall. Prior to the August recess both chambers failed to pass any surprise billing legislation. The House’s surprise billing legislation H.R. 3630, No Surprises Act, was passed out of the Energy and Commerce Committee in July. The House bill included an amendment in the nature of a substitute which included ab independent dispute resolution (IDR) process for these surprise billing claims. The IDR process has been a point of contention in both the House and the Senate because not all members nor stakeholders agree on whether or not this measure should be included. This has caused delays in movement in the House bill as well as the Senate version, S. 1895 Lower Health Care Costs Act. ASTCT will continue to monitor the progress of surprise billing issues once Congress reconvenes.
CMS Podcast- In this episode of Beyond the Policy, Administrator Verma discusses the Blue Button Developers Conference, which brings together top private-sector developers who are helping CMS to better serve Medicare beneficiaries by leveraging Medicare claims data.
KHN Article- Kaiser Health News takes a look and Congress’ surprise billing legislation and address the long term effects it could have.
The Hill Article- This article discusses a news briefing from the World Health Organization stating that there has been three times as many measles cases reported than last year.
HHS Surgeon General Advisory- The recording from the press conference of Secretary Azar and Surgeon General Jerome Adams addressing public health issues.
Health Affairs Blog Post- The post discusses a new HHS policy on drug coupons that the Department has walked back.
District Work-The local Madison, WI news reports that Rep. Pocan (D-WI) discussed the Congressional priorities for fall 2019 to a group of constituents.
Alycia Maloney is ASTCT's Director of Government Relations.