Policy Perspectives: Continuing to Track COVID-19

The Public Health Emergency (PHE) declaration for COVID-19 is set to expire on July 25 if it is not extended. The Department of Health and Human Services (HHS) has mentioned that they expect to extend the PHE by 90 days, however there is no formal extension as of yet. Additionally, many stakeholders have reached out to the Administration regarding the July 25 PHE deadline and have expressed concerns for the delivery of effective and efficient care. AMA’s statement can be found here.

HHS also put out a statement on June 29 that announced an agreement by the Administration to secure a large supply of therapies for the first authorized drug for COVID-19. The agreement with Gilead Sciences ensures treatments for American hospitals through September. Find more information about the statement here.

As the nation continues to operate under the uncertainty of the coronavirus pandemic, Congress has taken 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. HHS last updated their FAQs on June 25, be sure to regularly check for updates.

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.

Rest of the Legislative Year

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 at the end of July. The focus of the fourth bill is still undetermined however there will likely be some unemployment insurance issues covered. An additional funding package will be among some of the legislation that must pass by years end. Congress is expected to pass its extenders package for programs that will be expiring this year as well as its appropriations bills for the upcoming fiscal year.

The legislative calendar is slim for the rest of the year considering Members will be in their district over the Fourth of July holiday and will have August recess three weeks later. Additionally, with 2020 as an election year the window for legislation closes sooner than it would in a non-election year. For more information on Congressional calendars please see here and here.

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.

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.

The submittal deadline for comments is July 10 at 5pm EST. To submit your own comments please do so at www.regulations.gov.

ASTCT IPPS Response

ASTCT is currently in the process of crafting its response to the FY21 IPPS proposed rule, however, a draft of the comments will be shared and available prior to the deadline.

ASTCT’s recommendations to CMS include:

Supporting the proposal to create a new CAR-T MS-DRG and requesting CMS to finalize that proposal
Recommending CMS adopt revenue code 0891 charges as drug charges for purposes of rate-setting
Update their methodology for payment for clinical trial cases to reflect actual acquisition cost for claims data
Recommending that ICD-10-CM codes for CRS be assigned a higher severity level
Suggesting CMS to not require transplant centers to submit a standard averages charge for donor search and cell, rather allow providers to report actual acquisition costs
Requesting further guidance and clarification on record keeping for transplant centers
Requiring further transparency on the coding committee processes.

This list of priorities is not exhaustive, however, ASTCT did its best to weigh in on the most crucial elements of the proposed rule that directly impact our community. For information on ASTCT’s draft please contact info@astct.org.

ASTCT Support for Work Visas

ASTCT sent a letter of support to the Senate regarding the Healthcare Workforce Resilience Act (S. 3599). The bill makes unused visas available to nurses and physicians who petition for them before the date that is 90 days after the end of the declared national emergency relating to coronavirus. More information on the bill can be found here. This is an important issue for ASTCT because many of our physicians and healthcare workforce will have limited ability to practice if this bill is not passed. ASTCT’s letter of support for the legislation is below. Senators Perdue, Durbin, Young and Coons are trying to get the legislation into the next healthcare legislative vehicle. Updates on the legislation will be forth coming.

On June 22, President Trump issued and Executive Order that suspends entry into the United States of any alien immigrant seeking entry pursuant to nonimmigrant visas through December 31, 2020. The order includes any H-1B or H-2b visas along with any family accompaniment. ASTCT is concerned with the executive order because it will impact healthcare workforce and may leave patients with limited care options during a global pandemic, potentially slow down innovative research and adversely affect the future healthcare workforce if talented professionals are not able to contribute to the American healthcare system. ASTCT will continue to monitor this issue as it develops.