Knowledge Base Article

CMS Administrator Seema Verma is quoted as saying in an April 23rd Press Release that “transformative technologies are coming to the private market, but Medicare’s antiquated payment systems have not contemplated these technologies…I am particularly concerned about cases that have been reported to the agency in which Medicare’s inadequate payment has led hospitals to curtail access to needed therapies. We must continually update our policies in response to the rapid pace of advancement in medical science.”

Over the past two weeks we have covered finalized changes to ICD-10-CM diagnosis code severity designation and MS-DRGs found in the FY 2020 IPPS Final Rule. This week we examine the finalized New Technology Add-On Payments.

Background

Annually, CMS addresses applications for new technology add-on payments in the IPPS proposed rule. They do not make proposals, instead the proposed rule describes any concerns they may have about an applicant meeting the criteria for payment as a new technology and seeks additional information as needed to make a decision in the IPPS final rule. To be eligible for an add-on payment a new technology must meet the following three criteria:

• The medical service or technology must be new;
• The medical service or technology must be costly such that the DRG rate otherwise applicable to discharges involving the medical service or technology is determined to be inadequate; and
• The service or technology must demonstrate a substantial clinical improvement over existing services or technologies.

Once a new technology add-on payment status is granted hospitals are eligible to receive the payment for up to three years.

Increasing Add-On-Payment Amount

For FY 2019, the calculation for add-on payments is based on cost to hospitals for the new medical service or technology. Specifically, Medicare makes an add-on payment equal to the lesser of the following:

• 50% of the costs of the new medical service or technology, or
• 50% of the amount by which the costs of the case exceed the standard DRG payment.

In response to concerns from commenters and stakeholders, CMS agrees “that capping the add-on payment amount at 50 percent could, in some cases, no longer provide a sufficient incentive for the use of the technology.” As such, for discharges on or after October 1, 2019, CMS finalized their proposal to make the add-on payment be equal to the lesser of the following:

• 65% of the costs of the new medical service or technology, or
• 65% of the amount by which the costs of the case exceed the standard DRG payment.

New Technology Add-On Payment for Qualified Infectious Disease Products

CMS received comments and concerns related to antimicrobial resistance and its serious impact on Medicare beneficiaries and public health overall and finalized that for medical products designated as a Qualified Infectious Disease Product (QIDP) by the FDA, “if the costs of a discharge involving a new medical service or technology exceed the full DRG payment…Medicare will make an add-on payment equal to the lesser of (1) 75 percent of the costs of the new medical service or technology; or (2) 75 percent of the amount by which the costs of the case exceed the standard DRG payment.”

CMS Finalizes Proposal to Modernize Payment Policies for Medical Devices Meeting FDA’s Breakthrough Devices Designation

In December 2018 the U.S. Food and Drug Administration (FDA) implemented the Breakthrough Devices Program. At that time, the FDA indicated this “is a voluntary program for certain medical devices and device-led combination products that provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions…this program is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health.”

CMS finalized the proposal that “for applications received for IPPS new technology add-on payments for FY 2021 and subsequent fiscal years, if a medical device is part of the FDA’s Breakthrough Devices Program and received FDA marketing authorization, such a device would be considered new and not substantially similar to an existing technology for purposes of new technology add-on payment under the IPPS.” CMS also finalized extending this proposal to products designated by the FDA as a QIDP.

Applications for New Technology Add-On Payments for FY 2020

• For FY 2020, CMS proposed to continue 10 of 13 technologies receiving NTAP in FY 2019.
• The remaining 3 of 13 technologies receiving NTAP in FY 2019 were no longer considered “new” and have been discontinued for FY 2020.
• There were 17 new applicants for new technology add-on payment for FY 2020
• Eight of the 17 new applicants discussed in the proposed rule either withdrew their application, did not receive FDA approval by the deadline of July 1 or after evaluation CMS found they did not meet the criteria to be considered a new technology.
• Effective October 1, 2019, there will be 19 New Technologies eligible for Add-On Payments.

CMS estimates the payment amounts for new technology add-on payments in the Final Rule based on the applicant’s estimates. This amount and the estimated number of patients is highlighted in the following table:  

‍For Your Consideration

While the number of patients estimated to receive one of the FY 2020 technologies approved for add-on payments is relatively small, this is an opportunity not to be missed for those hospitals providing the service. Looking at paid claims data in RealTime Medicare Data (RTMD), it appears that not all hospitals are taking advantage of the additional payment opportunity by not including a code for these medical services or technologies on the claim. That said, some questions come to mind for you to think about:

• Is your hospital providing any of these medical services or technology?
• Who needs to be aware of what the new technologies are? (i.e. Physicians, Pharmacy, Coding Professionals, Clinical Documentation Integrity Specialists, Case Managers)
• What process do you have in place to alert your Coding Staff of the need to code the new technologies?

To help you get started, I have put together a document detailing each New Technology including a description of the technology, the ICD-10-PCS code(s) and code description and the maximum new technology add-on payment in FY 2019 and for FY 2020. To download this document, click here.