CAR-T Therapy: Reflecting on our accomplishments and a look ahead
ASBMT has devoted significant time and resources to protecting appropriate patient access to CAR-T therapy and improving provider reimbursement for the therapy in 2018. There is still a great deal that must be done in the New Year, but as 2018 comes to a close, I want to take this opportunity to reflect on all the organization has been able to accomplish.
Many of you have been engaged in the research on CAR-T, delivered the therapy as part of clinical trials, and practice at the centers delivering this therapy to patients. Your expertise has been integral to the Association’s work and allowed us to have meaningful engagement with the Centers for Medicare and Medicaid Services (CMS) as Kymriah was awaiting Food and Drug Administration (FDA) approval in 2017. ASBMT has been raising concerns about patient access and equitable reimbursement with CMS even as the first Medicare patients were receiving this therapy.
In the last year, ASBMT has meaningfully engaged with CMS on all of the following topics related to CAR-T:
- Proposals to improve inpatient and outpatient reimbursement;
- Improving the accuracy and transparency of coding;
- The initiation of the National Coverage Analysis (NCA); and
- Value-based payment model options to be implemented once more data is collected and providers have more experience with the therapy.
While we did not always achieve our desired outcome, ASBMT has continued to advance these discussions with CMS. We have detailed our success and setbacks in CAR-T reimbursement policy in this space over the last 12 months, so I won’t repeat all of that now. Instead, I want to take the opportunity to thank all of you for sharing your experiences, positive and negative, with ASBMT staff and consultants. Your feedback has been critical to allowing us to propose innovative policy solutions and to be seen as the leaders in this field. ASBMT has successfully partnered with other organizations, like the American Society of Hematology (ASH) and the Association of Dedicated Cancer Centers (ADCC), and has been recognized as the organization that is developing and proposing meaningful policy solutions. We continue to engage in more meaningful collaborations all focused on improving CAR-T reimbursement policy.
Looking ahead to 2019, we will continue to be the advocacy leaders in this space. Early in the year, ASBMT will be launching a Government Relations Committee that will play an integral role in CAR-T policy issues. If you are interested in joining this committee, email a statement of interest to governmentaffairs@asbmt.org.
We are also planning to hold a meeting with CMS early in the year in advance of the start of the inpatient rulemaking for FY 2020 to discuss short and long term policy solutions. Besides focusing our efforts on CMS, we will also be discussing our concerns and potential policy solutions with Members of Congress and are already scheduling meetings with key members for early in January in conjunction with ASH. ASBMT and ASH will be doing these Hill meetings with the goal of having key members make the same policy requests to improve reimbursement as we are to CMS.
Again, thank you for all the work you have done and continue to do in this space. In 2019, we remain dedicated to finding meaningful solutions to ensure your patients have access to CAR-T and other potentially lifesaving therapies. We will continue to keep you updated on our efforts in this space, as well as through regular Town Hall webinars on CAR-T and other topics important to membership.
OPPS/PFS Town Hall
On December 12, ASBMT policy advisors Jugna Shah and Erika Miller held a Town Hall to educate members on the policies finalized in the Medicare Outpatient Prospective Payment System (OPPS) and Physician Fee Schedule (PFS) rules for CY 2019. These rules included many policies of interest to ASBMT members, including reimbursement for HCT and CAR-T therapy in the outpatient setting, documentation and payment changes for physician office visits, and the Quality Payment Program. If you missed the webinar, the slides are available here.
Affordable Care Act Update
Late on December 14, 2018, the day before the 2019 Affordable Care Act (ACA) open enrollment period closed, a judge ruled in Texas vs. United States that the ACA in its entirely was unconstitutional. Earlier this year, 20 Republican state attorneys general and governors filed the lawsuit challenging the constitutionality of the ACA now that the Tax Cuts and Jobs Act, the tax reform package passed in December 2017, zeroed out the individual mandate penalty as of January 1, 2019. In his decision, the Texas judge referenced a prior Supreme Court ruling that the ACA is a tax and found that the individual mandate was not severable from the rest of the law, forcing him to find the entire ACA unconstitutional.
The judge did not issue an injunction that would have immediately ceased implementation of the ACA. Therefore, there will be no immediate impact on patients or providers. Democratic state attorneys general plan to appeal the ruling, and it may go all the way to the Supreme Court. As the appeals process proceeds, people will still have coverage through ACA exchange plans and the Medicaid expansion. Insurers must still follow ACA patient protections, like the ban on pre-existing conditions exclusions and lifetime caps. The payment reforms included in the law, including demonstrations run by the Center for Medicare and Medicaid Innovation, will also continue.
ASBMT will be monitoring the case as it works its way through the appeals courts and will notify members of any developments, particularly those that will impact patient access to appropriate care.
Congressional Health Bills
In the final days of the 115th Congress’ lame duck session, both chambers slipped in late actions on health care bills. The House passed S. 2465, the Sickle Cell Disease & Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2018 (ASBMT joined a coalition supporting this legislation with the American Society of Hematology and other organizations, which we addressed in our August Policy Perspectives). The House also passed S. 3029, the Prematurity Research Expansion & Education for Mothers who deliver Infants Early (PREEMIE) Act. Both bills were signed into law by President Donald Trump on December 19th, 2018.
Additionally, the House passed H.R. 7217, the Improving Medicaid Programs & Opportunities for Eligible Beneficiaries (IMPROVE) Act. This bipartisan package of Medicaid bills includes new provisions aimed at addressing overcharging for drugs in the Medicaid program (especially cracking down on misclassifications of branded drugs as generics, an issue which gained notoriety with Mylan’s EpiPen last year), improving care for children on Medicaid, and extending short-term funding for various programs.
Medicare Advantage/Part D Proposal Released
The Centers for Medicare & Medicaid Services (CMS) released a new proposal to modify and modernize the Medicare Parts C (Medicare Advantage) and D (Prescription Drug Benefit) programs for CY 2020. The proposal comes as part of the administration’s efforts to reduce drug pricing across the board. The proposed changes include: providing Part D plans with greater flexibility to negotiate discounts for some protected classes, increasing transparency around out-of-pocket costs for patients, and implementing the prohibition on pharmacy gag clauses recently signed into law. For more information on the proposal from CMS, click here.
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CMS Approves Outcome-Based Drug Pricing Proposal in Michigan
CMS recently approved a proposal by the Michigan Medicaid program to negotiate drug prices based on the outcomes the drugs achieve. CMS Administrator Seema Verma announced the approval of the plan as part of the administration’s larger efforts to reduce drug prices in the U.S. healthcare system. The agency approved a similar waiver request from the state of Oklahoma earlier this year. To read more, click here.
FDA Announces Changes to Medical Device Approval Process
The Food & Drug Administration announced changes to the 510(k) program, which dictates the approval process for new medical devices. The FDA is tasked with evaluating the safety and effectiveness of medical devices before they are allowed to hit the U.S. market. The commonly used 510(k) pathway allows manufacturers to request an expedited process if they demonstrate their products are significantly similar to products grandfathered-in products on the market before 1976. Recent investigations have demonstrated instances of the expedited process missing key issues with new devices that may have put patients and consumers at risk. To read the statement by FDA Commissioner Scott Gottlieb, click here. For more information on the changes, click here.
MEDPAC Meeting on Hospital Payment Rates
The Medicare Payment Advisory Commission (MEDPAC) discussed hospital inpatient and outpatient payment rates at their meeting on December 6 and 7. During the public comment period, ASBMT shared the impact of the payment rates on patient access and provider reimbursement for CAR-T therapy. ASBMT will continue to work with MEDPAC, the administration, Congress and other stakeholders to ensure that CAR-T is available to all appropriate patients and that personalized and patient-first care is not hampered by inadequate reimbursement levels.
Comment Letter Submitted on FDA Draft Guidance Documents
ASBMT submitted comments on December 10 to the Food and Drug Administration (FDA) in support of the Foundation for the Accreditation of Cellular Therapy (FACT) comments on two draft guidance documents. ASBMT concurred that the guidance on “Chemistry, Manufacturing and Control (CMC) Information for Human Gene Therapy Investigational New Drug Application” is useful for users and encouraged FDA to adopt FACT’s recommendations to improve standardization and quality controls. The letter also encouraged FDA to share FACT’s suggestions for compliance with manufacturers for the “Long Term Follow-up after Administration of Human Gene Therapy Products” draft guidance.
ICYMI
There Is a Magic Bullet for Some Cancers. What If It Misses? – Bloomberg takes a look at the promise of CAR-T therapy and its outcomes. This article focuses on some of the difficulties with patients who relapse after receiving CAR-T and managing expectations with the treatment.
Hospital Chain Settles U.S. Suit Over Stifled Competition – The Wall Street Journal analyzes Atrium Health’s settlement regarding anticompetitive language in insurer contracts.
When Hospitals Merge to Save Money, Patients Often Pay More – The New York Times explores the effects of increasing hospital mergers on health care costs.
Check Your Medical Records for Dangerous Errors – This Kaiser Health News column takes a look at medical record errors and their impacts on patients.
The Drug Pricing Maze – As drug pricing continues to eat up more of the health care policy debate, Axios does a deep dive into the policy implications of the pharmaceutical pricing system.