Advocacy Update

Read the Advocacy Update

• Trump Signs COVID-19 Relief Package Provisions Affecting Pathologists, Laboratories
• New Billing Details for Medicare’s 2-Day Turnaround Policy for COVID-19 Tests
• Save the Date: 2021 Pathologists Leadership Summit, May 1-4, 2021
• Test Your Year-End Advocacy News Knowledge

For several months, the CAP had urged Congress to enact additional relief to alleviate the effects of the coronavirus pandemic and further support pathologists and laboratories. In year-end legislation that mitigated future Medicare payment cuts to pathologists, which passed by the House and Senate on December 21, the Congress provided additional monies for public health, physician and other health care provider support, and financial and economic relief. President Donald Trump signed the bill into law on December 27.

In addition to the relief from 2021 Medicare cuts that the CAP and other physician associations secured, the following provisions will affect the US health care system:

• Public Health and Social Services Emergency Fund: $22.9 billion to prevent, prepare for, and respond to the coronavirus. The fund includes money for testing, contact tracing, surveillance, containment, and mitigation to monitor and suppress COVID-19. The testing component is for both active infection and prior exposure and supports the development of testing plans.
• Strategic National Stockpile: $3.25 billion to reinforce the national supply of medical supplies.
• Provider Support Relief Fund Payments: $3 billion for the Provider Relief Fund and ensures 85% of the monies currently obligated for the fund are allocated equitably. The legislation also allows additional flexibility for physicians and providers by clarifying that eligible individuals may transfer all or any portion of the payments among subsidiary eligible health care providers of the parent organization.
• Rural Health Investments: Increases Medicare payments to rural health clinics subject to a payment cap by phasing-in an increase in payment and extends a provision that ensures Medicare physician payments reflect the local cost of care.
• Paycheck Protection Program: $284.5 billion for first- and second-time borrowers. It offers a process for small businesses, a simplified loan forgiveness application for loans under $150,000, and other reforms. In addition, it develops a process for small businesses to receive a second loan if the small business has less than 300 employees and can demonstrate a revenue reduction of 25%.
• Graduate Medical Education: Adds 1,000 new Medicare-funded graduate medical education full-time equivalent residency positions beginning in fiscal year 2023.
• Transparency in Health Care: Bans gag clauses in contracts between providers and health plans that prevent enrollees, plan sponsors, or referring providers from seeing cost and quality data on providers.

Read more about these and other provisions in the legislation.

While the CAP firmly opposed the Centers for Medicare & Medicaid Services’ (CMS’) cuts to fees for certain COVID-19 tests, the agency will move forward with implementing its new payment policy for high-throughput tests to detect SARS-CoV-2 on January 1, 2021. The CAP maintains that the CMS should not cut fees during a global pandemic nor penalize laboratories for issues, such as national shortages for testing supplies, outside of their control.

On October 15, the CMS announced it would reduce the fee for clinical diagnostic laboratory tests (CDLTs) run on certain high-throughput platforms by 25% beginning January 1, 2021. In an October 16 letter to the CMS, the CAP called on the administration to cease implementation of the new payment structure. The CMS declined the CAP’s request and plans to move forward with its ruling and further updated frequently asked questions detailing how it plans to implement the new policy. The CAP still opposes the change.

How Much Medicare Will Pay for High-Throughput COVID-19 Tests

Beginning January 1, 2021, the revised payment amounts will be:

• $75 per test for CDLTs making use of high-throughput technologies for the detection of SARS-CoV-2 or the diagnosis of the virus that causes COVID-19, as identified by HCPCS codes U0003 and U0004.
• $25 add-on payment as identified by HCPCS code U0005. As required by the HCPCS code U0005 descriptor, this add-on payment may be billed with either HCPCS code U0003 or U0004 when the applicable test is completed within 2 calendar days of the specimen being collected.

Laboratories that do not complete the CDLT making use of high-throughput technologies for the detection of SARS-CoV-2 or the diagnosis of the virus that causes COVID-19 within two calendar days may not bill HCPCS code U0005 and will not receive the $25 add-on payment. Payment for these CDLTs will be $75.

How Can Laboratories Meet the Two-Day Turnaround Time Requirement?

To bill the U0005 add-on code and receive the additional $25, a laboratory must meet the following requirements:

• Complete the COVID-19 CDLT in two calendar days or less from the date of specimen collection, and
• Complete the majority of its COVID-19 CDLTs using high throughput technology in the previous calendar month within two calendar days or less for all of its patients (not just Medicare patients).

To comply with the requirements, laboratories should assess the timeliness of those tests in the month preceding the month identified by the line date of service for the corresponding test (U0003 or U0004). This means laboratories must complete 51% of their CDLTs making use of the testing technology to diagnosis of COVID-19 within two calendar days from the date the specimen was collected during the applicable month. In the event of an audit or medical review, the CMS said laboratories will need to produce documentation of meeting the requirement for timeliness.

The CMS notes that a test is complete when the results of a test is finalized and ready for release. The CMS gives this example:

A laboratory is submitting a claim to Medicare for a CDLT performed on high throughput technology for the detection of SARS-CoV-2 or the diagnosis of the virus that causes COVID-19 using HCPCS code U0003 with a line date of service of May 15, 2021. The laboratory would assess its performance based on those CDLTs completed during the calendar month (April 1, 2021 – April 30, 2021) that precedes the month identified by the CDLT line date of service (May 2021). If the laboratory completed a total of 1,000 of the same CDLTs using high throughput technology (including all tests from non-Medicare patients) in April, and 490 had been completed within 2 calendar days of the specimen being collected, the laboratory would have a 49% test timeliness completion rate and may not bill for the $25 add-on payment as represented by HCPCS code U0005.

What Constitutes as Two Days

The two-day timeframe begins on the date the specimen is collected. For example, if a specimen is collected anytime on a Wednesday then the high-throughput test would need to be completed by 11:59 PM on Friday, the CMS said. In other words, Wednesday is day 0, Thursday is day 1, and Friday is day 2.

This is the last week to take the December Advocacy News Quiz. Last month, over 80 pathologists took the quiz. See how you compare against your fellow CAP members’ in the December News Quiz

Take the December news quiz