ASTCT’s Continued Engagement on CAR-T
ASTCT remains involved in conversations with the Centers for Medicare and Medicaid (CMS) along with Capitol Hill regarding policy changes for CAR-T therapies. On March 15, CMS released a transmittal with updates on CAR-T coding and billing in the Hospital Outpatient Prospective Payment System (HOPPS) effective on April 1. The transmittal states, effective April 1, 2019 hospitals may report the new CAR-T revenue codes 087X (Cell/Gene Therapy) and 089X (Pharmacy) and value code 086X (Invoice Cost) established by the National Uniform Billing Committee when reporting claims so that the agency may track utilization and cost data.
In the transmittal CMS provided three claim scenarios which can be found here. In one of the scenarios, CMS describes that when viable T-cells are administered in the hospital outpatient setting providers should report the new Category III CPT code 0540T for the administration and HCPCS Q-code Q2041 or Q2042 as appropriate for the drug or biologic. Further, the transmittal states that services in support of the administration, such as CAR-T cell collection, dosing and preparation, may be reported as non-covered charges on the outpatient claim. The reference to reporting cell collection and cell processing as non-covered was greatly concerning to ASTCT given these are Part B hospital services ordered by a physician. Not unlike collection and cell processing services associated with autologous stem cell transplant which are not only covered, but also separately paid. Moreover, CAR-T cell collection is specifically referenced in CMS’ March 2019 proposed coverage decision memo as a covered service in support of the overall treatment protocol.
CMS’ third claim example indicates that when the CAR-T cell infusion/administration occurs in the inpatient setting, hospitals may report these very same cell collection and cell processing services as covered but they must do so by first holding these charges when they occur in the outpatient setting and reporting them as part of the pharmacy charge of the CAR-T product when it’s billed on the inpatient claim. ASTCT is continuing to question CMS’ instruction about holding and moving charges from the outpatient visit that occurs weeks prior to an infusion service. In most cases today, these services occur in the inpatient setting and by comingling what are clinic and lab services with the actual drug product code, by either embedding dollars for these things into the product dollar charge reported as covered as part of the inpatient claim, remains unclear to providers. There is outstanding confusion and questions which is why providers and ASTCT are continuing to review this transmittal and question CMS on it.
With many outstanding questions, ASTCT representatives attended the National Uniform Billing Committee (NUBC) meeting on April, 9 in Baltimore, MD. CMS staff were in attendance at the meeting and there was a robust conversation on the different interpretations of the transmittal. The feedback CMS provided explained their point of view that because the current CAR-T products were FDA approved as biologics everything associated with producing the biologic, even the hospital services of cell collection and processing, appear to be considered by CMS part of the biologic and thus paid for through the manufacturer’s ASP. However, as ASTCT and the NUBC interpreted the transmittal, the manufacturer’s ASP does not cover those services and thus providers are not being reimbursed for providing these services by the manufacturer or by CMS since they do not accept the Category III CPT codes for cell collection or cell processing.
What was clear from the NUBC meeting is that ASTCT was not alone in expressing its concerns. Members of the NUBC were deeply concerned and raised multiple questions to CMS staff. The Committee’s chief complaint was that CMS instructed providers to submit claims in a way that goes against NUBC requirements and since the NUBC is the legally governing body of transaction code sets under HIPAA, all payer and all providers must abide by NUBC requirements. From that meeting, the NUBC determined that it would form a small working group to sort through the transmittal’s sticking points and provide CMS with a detailed list of concerns. Fortunately, CMS heard the confusion the transmittal has created, not to mention the serious concerns the NUBC raised about the legality of what CMS was doing, and said they would reconvene internally over the next few weeks and either revise or give further guidance on the transmittal.
ASTCT held a webinar on this issue on April 23. The recording of the webinar and the presented slides can be found here.
Additional information on the HOPPS rule can be found here and here.
ASTCT will continue to engage with CMS and will relay any updates from the agency as they become available.
CMS IPPS Proposed Rule
ASTCT released the following statement on the proposed rule:
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 assure appropriate patient access to this lifesaving therapy and will continue to work with the agency on this important issue.
ASTCT applauds CMS for being responsive to our concerns about CAR-T reimbursement by releasing some specific proposals and a request for comments on a number of additional ideas. Some of the issues outlined in the proposed rule reflect the concerns and proposals ASTCT has provided CMS over the past 18 months. While we are encouraged by the forward movement, ASTCT believes that the proposal does not go far enough to protect patient access and does not address the significant reimbursement inadequacies that make delivering these therapies to Medicare patients unsustainable for centers.
The agency proposed to increase the amount of the new technology add-on payment (NTAP) for all eligible services, including the two approved CARs, from 50 percent to 65 percent of the cost. Previously, ASTCT had recommended increasing the maximum NTAP to 80%, which still would not cover the full cost of CAR-T therapy but would provide much needed relief to providers. In what appears to be a response to an ASTCT recommendation from last year, CMS requests comments on eliminating the NTAP payment calculation for the two currently approved CAR-T products and replacing the calculation with a uniform payment in the amount of $242,500 (65% of the product cost). In addition, CMS is looking for input on developing a new MS-DRG and is interested in receiving feedback on creating alternative payment models for CAR-T. ASTCT is still examining these requests and will provide feedback to the agency.
ASTCT is pleased that CMS is engaged on the issue of improving reimbursement for current and future CAR-T therapies. We welcome the opportunity to continue to work with CMS to ensure these policy changes support the needs of patients. ASTCT is reviewing the proposed rule and appreciates the opportunity to respond with comments.
To view the proposed rule please click here. Additionally, CMS’ press release can be found here.
OMB Memo
On April 11, the Office of Management and Budget (OMB) released a memorandum that reinforces the obligations of the Federal agencies under the Congressional Review Act in order to ensure consistent compliance with the act’s requirements. This means that any guidance put out by a federal agency can be reviewed and voted on by Congress prior to enactment. This could significantly slow down FDA guidance and slow policy development for cell and gene therapies. ASTCT will be engaging on the Hill with this matter and voicing our opposition. We will continue to monitor this. More information on the memorandum can be found here.
Capitol Hill Activity
Both the House of Representatives and the Senate have been busy with drug pricing legislation and hearings in the 116th Congress. The House Ways and Means Committee and the Energy and Commerce Committee held mark ups on bills that they have passed out of committee and sent to the full House for consideration.
The Energy and Commerce bills include measures to improve price transparency, eliminate barriers to drug and biosimilar competition, and address REMs abuses. The bills also include ACA reforms that would provide federal funds to state reinsurance programs and stop policies that expand short term limited duration plans.
The Ways and Means Committee reported out H.R. 2113, the Prescription Drug Star Act. Provisions in that bill include measures that require manufacturers to publicly justify large price increases for existing drugs and high initial prices for new drugs; requires applicable manufacturers to report to the Secretary of HHS the total aggregate monetary value and quantity of samples provided to certain health care providers for patients’ use; the bill also requires HHS Secretary to conduct a study on Part A drug costs and the impact of shortages; requires the Secretary of HHS to publicly disclose the aggregate rebates, discounts, and other price concessions achieved by PBMs on a public website; and it requires all manufacturers to submit information to the Secretary on the ASP for Part B drugs.
The Senate Finance committee also held a hearing on Drug Pricing in America as part of their 3 part series of investigative hearings on pricing.
ASTCT will continue to monitor the activity on Capitol Hill.
PCORI Reauthorization
As of December 2018, Patient-Centered Outcomes Research Institute (PCORI) has awarded more than $2.4 billion in grants to more than 600 research-related projects in 44 states across the U.S. PCORI-funded research also supports personalized care by discouraging ineffective and low-value care.
Authorized by the Affordable Care Act (ACA), PCORI funding expires on September 30 and will need to be reauthorized by Congress. Senators Bill Cassidy (R-LA), Shelley Moore Capito (R-WV), Chris Van Hollen (D-MD) and Mark Warner (D-VA) plan to develop and introduce reauthorization legislation in the Senate, but are still determining its content, including the length of a reauthorization and whether to preserve the existing funding mechanism. On the House side, Representatives Diana DeGette (D-CO), Don Beyer (D-VA), Fred Upton (R-MI) and Tom Reed (R-NY) have come forward to lead the effort.
There are currently two letters being circulated in the House and Senate that ask the leadership to reauthorize PCORI. ASTCT is supportive of these efforts. More information on PCORI can be found here.
ICYMI
Drug Pricing, Access, and Innovation—In an editorial piece by former Acting Administrator of CMS, Andy Slavitt, and former FDA Commissioner, Robert Califf, the pair discuss US health outcomes and the effects that policy solutions can have to reduce drug costs while increasing access to beneficial drugs, all while continuing to incentivize innovation. They recommend a sustainable, fair payment system in which drug prices reflect the value provided and reward innovations that improve outcomes.
Pushback on CMS’ Approach to National CAR-T Coverage—Modern Healthcare’s article describes the concerns both hospitals and exempt cancer centers have regarding the final decision for a national coverage analysis by CMS on CAR-T therapies. Many have expressed that this policy is premature and many centers have emphasized the additional burdens it may place on providers and institutions. The final decision from CMS is expect to come out on May 17.
NIH Streamlines Gene Therapy Oversight—On April 25, the NIH released amended guidelines as part of the 2018 joint proposal from NIH and FDA to streamline duplicative and burdensome oversight over gene therapy. The amended guidelines can be found here.
CMS Proposes Change to Wage Index—As part of the recently released IPPS rule, CMS proposed to increase the wage index that sets the nation’s hospital payments to address the disparity in the system between urban and rural hospitals. The proposal would be in effect for four years and would also decrease the wage index for hospitals above the 75th percentile.