As the nation still operates under the uncertainty of the coronavirus pandemic, Congress has taken a number of measures to pass legislation to aid the American public. On March 27, 2020 the Coronavirus Aid, Relief, and Economic Security (CARES) Act was signed into law which provided over $2 trillion in economic relief from the public health emergency of COVID-19. CARES Act is intended to provide economic relief for American workers, families, and small business to preserve American jobs and industries. In addition to small business loans and assistance for families through the Paycheck Protection Program, Congress also included the Provider Relief Fund (PRF). The PRF allows the Department of Health and Human Services (HHS) to distribute $175 billion to hospitals and healthcare providers on the front lines of the coronavirus response.
The breakdown of the distributions of funds can be found on HHS’ website. Additionally, healthcare providers can find further information how to accept the funds here and answers to FAQs here. Of note, as of May 22, 2020 HHS announced an extension of the 45-day compliance deadline to 90 days. The Department stated, “Today, the U.S. Department of Health and Human Services (HHS) is announcing a 45 day deadline extension for providers who are receiving payments from the Provider Relief Fund to accept the Terms and Conditions for Provider Relief Fund payments. This announcement means providers have now been granted 90 days from the date they received a payment to accept HHS Terms and Conditions or return the funds.” To keep up-to-date on the latest news releases from HHS visit their website.
The House and Senate are continuing to work on funding packages to provider further economic relief. Currently, Congress is working on the fourth funding bill that is expected to be completed in June 2020. The fourth bill will focus on unemployment insurance and then Congress may take time to evaluate the remaining needs of the country before beginning negotiations for an additional funding package.
In the meantime, the President has issued guidelines for Opening up American Again. Largely, each state Governor has determined how they will use the “phasing-in” approach to reopening their individual states. Even though some states are easing their restrictions, CDC recently reported that over 100,000 people in the United States have passed away from COVID-19. The path forward to resuming “normal life” still remains uncertain, however, please visit your state governor’s website for the most accurate and up-to-date information.
ASTCT and COVID-19
ASTCT physicians and healthcare providers have seen first-hand the impact coronavirus has had for patients. With a population of patients with the most comprised immune systems, ASTCT has worked hard to stay informed and to keep others informed on the best protocols for patients and for institutions. ASTCT has provided a COVID-19 resource page that is regularly updated with guidelines, webinars, news updates, and external resources. This information is a publicly available resource.
FY2021 IPPS Proposed Rule
On May 11, the Centers for Medicare and Medicaid Services (CMS) released the FY2021 Hospital Inpatient Prospective Payment System proposed rule. CMS stated that the objective of the proposed rule is to “transfor[m] the healthcare delivery system through competition and innovation to provide patients with better value and results.” CMS presented twenty-four new applications for new technology add-on payment (NTAP) for FY2021, however, for the eighteen technologies currently receiving NTAP on 10 will continue to receive the add-on payment. Of the eight technologies that will no longer be “in their newness” for FY 2021 includes Chimeric Antigen Receptor T-cell therapies (CAR-T). ASTCT has advocated for the extension of the NTAP for CAR-T therapies in order for additional, more accurate data to be collected by the agency. However, CMS did not extend the NTAP for these therapies.
Although, CMS did not extend the NTAP for CAR-T therapies, the agency did create a new MS-DRG for CAR-T. CMS put forth the proposal to create a new MS-DRG 018 for cases specific to CAR-T therapies and the payment group is intended to help predictably compensate hospitals for their costs in delivering these therapies to Medicare beneficiaries.
Additionally, the proposed rule addresses the implementation of the PACT Act (Sec. 108 of Further Consolidate Appropriations Act 2020), which reimburses for cell acquisition cost similar to that of solid organ transplant. ASTCT in partnership with NMDP is consulting with CMS on clarification on the requirements for providers to submit a standard donor acquisition charge. ASTCT’s comment letter to the agency will include this section as well.
CMS’ fact sheet on the proposed rule can be found here and the proposed rule itself can be found here.
On May 19, ASTCT held a webinar on our initial thoughts on the proposals put forth by CMS in the proposed rule. In the webinar we covered the specific proposals for CAR-T, which included the MS-DRG018 weight proposals to apply the adjusters such as wage-index and DSH charges. Additionally, CMS put forth a proposal for an updated outlier threshold payment with an increase of about $4,000 to $30,000 consistent with 5.1% of total IPPS payments. CMS also included its annual code changes which included new cytokine release syndrome codes. For more details on our initial thoughts please visit ASTCT’s website. Links to both the recording and slides can be found here.
Stay tuned for additional information coming from ASTCT as we go through the comment submittal process with CMS. For any questions please email firstname.lastname@example.org.
ASTCT Advocacy Recommendations for FY2021
In November 2019, ASTCT and ASH jointly submitted a letter on recommendations for the FY2021 IPPS proposed rule. Our letter can be found here. With the published proposed rule, CMS adopted many of the suggestions put forth by ASTCT and ASH, however, there are some outstanding questions we have that can be clarified in the final rule.
ASTCT continues to engage Congress with CAR-T therapy requests and helps members of Congress and staff to understand the importance of these innovative therapies and the institutions they represent in their districts. On February 12, a bipartisan group of 76 House members signed a letter to Administrator Verma requesting the creation of a new MS-DRG for CAR-T therapies. There remains continued engagement on these issues and support of ASTCT’s advocacy efforts. The bipartisan letter can be found here.