Advocacy Update

Read the Latest Issue of Advocacy Update

• 85% of Pathologists Report Adverse Economic Impacts from Pandemic, CAP Survey Finds
• CAP Objects to Congressional Effort to Penalize Labs for COVID-19 Test Delays
• FDA No Longer Issues EUAs for COVID-19 Laboratory-Developed Tests
• CMS Updates Terms for Accelerated and Advance Payments
• CAP Asks CMS to Include Biomarkers in Date-of-Service Policy
• Test Your Advocacy Knowledge with the News Quiz

The CAP surveyed board-certified pathologists nationwide and 85% reported the COVID-19 pandemic has negatively affected pathologists. The CAP’s latest survey confirmed the pandemic’s ongoing adverse effects on pathologists as the United States has relied on COVID-19 testing throughout this national crisis.

The CAP, which routinely conducts socioeconomic surveys of its members to better inform its advocacy, fielded this survey from August 31 through September 11. The CAP received 811 responses, constituting a 5.5% response rate, making the sample nationally representative with a +/-3.4 margin of error.

Read more about the survey by downloading a report and executive summary.

In this latest survey, the most prevalent impacts reported by pathologists were reductions in compensation and/or benefits, hiring freezes, delayed or postponed recruitment of pathologists, temporary furloughs, and requirements to take paid time off (PTO) or annual leave.

Approximately 90% reported a decrease in their practice’s estimated year-to-date (YTD) anatomic pathology (AP) testing volume and 75% reported a decrease in their practice’s clinical pathology test volume relative to the same period in 2019. The average estimated 2019-2020 decline in AP testing was 24.5% (median decline = 24.0%), and the average estimated 2019-2020 decline in non-COVID-19 CP testing was 15.9% (median decline = 19.0%). These estimated rates of decline still represent an improvement from the situation reported by respondents to the CAP’s April 2020 and June 2020 COVID-19 Laboratory Impact Surveys.

Another by-product of the pandemic for pathologists is increased stress. Seventy percent of pathologists surveyed reported having higher stress levels. Reports of increased stress levels are higher among practice leaders than nonpractice leaders.

In addition, 20% of the pathologists surveyed reported they began performing remote sign out after the pandemic began. When the pandemic started, the CAP advocated for pathologists to perform remote sign-out of primary diagnosis. Approximately 5% of respondents were using remote sign-out to perform digital pathology primary diagnosis (ie, whole slide imaging).

The CAP objected to new legislation that would penalize laboratories for any delay in COVID-19 testing, including when such delays are due to factors outside of a laboratory’s control.

On October 9, the CAP wrote House lawmakers with concerns over the SPEEDY COVID-19 PCR Test Act (HR 8496). The bill would adjust Medicare payment rates depending on how quickly laboratories provide tests for SARS-CoV-2, the virus that causes coronavirus disease. Laboratories returning results within 24 hours would receive a 25% increase in Medicare payment. Those that provide results within 48 hours receive the standard the standard Medicare payment rate. And, those test results returned after 72 hours would receive no reimbursement.

While pathologists and laboratories remain committed to providing patients with timely test results, they have no control on when they receive samples from patients since most specimens are collected offsite and are later sent to the laboratory. Furthermore, directors of CAP-accredited laboratories have consistently reported problems acquiring necessary reagents, test kits, and other supplies that impede COVID-19 testing.

“Any effort to penalize laboratories during a pandemic due to the multitude of problems within the supply chain and other matters outside their control will only exacerbate any current issues with testing,” the CAP stated. “Our attention must focus on proactive solutions that give pathologists and laboratories the resources requested to meet America’s diagnostic needs.”

Read the CAP’s letter to members of Congress

On October 7, the Food and Drug Administration (FDA) announced that it will no longer review emergency authorization applications (EUA) for laboratory-developed coronavirus tests or LDTs.

Following the FDA announcement, the CAP evaluated how the decision will affect clinical laboratories. The recent FDA decision affects tests created by an individual academic, commercial, or public health laboratories. The Department of Health and Human Services (HHS) had told the FDA that it does not have the legal authority to require a premarket review of such tests without rulemaking.

The FDA said it would end premarket reviews of LDTs to focus on diagnostics that can significantly increase testing capacity, such as point-of-care tests, home collection tests, and at-home tests.

The FDA updated their Frequently Asked Questions for laboratories to reflect this update. Read the FDA FAQs here and check out the resources below:

• HHS FAQs on LDTs
• Interim Guidance for Rapid Antigen Testing for SARS-CoV-2
• COVID-19 Information for Laboratories
• FAQs on COVID-19 for Laboratories
• CDC COVID-19 Website
• Clinical Laboratory COVID-19 Response Calls
• CDC Laboratory Outreach Communication System (LOCS)

The CMS announced updated terms for the Medicare Accelerated and Advance Payment Program, which reflects CAP-backed provisions recently enacted by Congress. Due to the pandemic's economic effects on pathologists and laboratories, the CAP asked Congress to make several changes to the Medicare Accelerated and Advance Payment Program, including those that extend the program participants’ repayment deadline and lowering the interest rate.

The legislation lowered the interest rate for these loans to 4% from 10.25% and extended the loan repayment period. The new repayment period will be one year from the issuance date of each provider’s accelerated or advance payment. After that first year, Medicare will automatically recoup 25% of Medicare payments otherwise owed to the provider or supplier for eleven months. At the end of the eleven months, recoupment will increase to 50% for another six months.

If a provider or supplier is unable to repay the total amount of the loan during this time-period, a total of 29 months, then the CMS will issue letters requiring repayment of any outstanding balance, subject to a 4% interest rate.

The CMS also provided information on requesting an Extended Repayment Schedule for providers experiencing financial hardships. The CMS will contact each provider regarding the repayment terms and amounts owed for any program payment issued.

For more information, read the CMS’ fact sheet and visit the CAP’s Practice Resources for Pathologists webpage.

In the latest response to the proposed 2021 Hospital Outpatient Prospective Payment System & Ambulatory Surgical Center regulation, the CAP asked the CMS to exclude Multianalyte Assays with Algorithmic Analysis (MAAA) from the outpatient payment system and add the service to the laboratory date of service policy. Additionally, the CAP urged the CMS to assign payable status indicators for CAR T-Cell therapies to enable hospitals to bill and be paid appropriately. The CAP further asked the CMS to reduce regulatory and reporting burdens for pathologists and the laboratories they serve to provide critical diagnostic medicine.

In the October 2 letter to the CMS, the CAP asked to “exclude cancer-related protein-based MAAAs, which are generally not performed in the hospital outpatient setting, from the Hospital [payment] policy and add them to laboratory date of service provisions instead.” Medicare would then pay for cancer-related protein-based MAAAs under the Clinical Laboratory Fee Schedule rather than being packaged with other services. The performing laboratory would bill Medicare directly for the test if it meets all the laboratory date of service requirements. The cancer-related protein-based MAAAs are typically used to guide and manage the patient’s potential future oncologic surgical and chemotherapeutic interventions.

The CAP requested that the CMS change the Status Indicator Assignment for CAR T-cell therapy Category III CPT Codes 0537T – 0539T. In the letter, the CAP explained that changing the status would be in line with the American Society of Hematology and the CMS Advisory Panel on Hospital Outpatient Payment recommendations. “Changing the status indicators from ‘B’ to ‘Q1’ would allow these patient services to be eligible for payment on the condition that no other procedures or visits were provided on the same claim,” the CAP said.

Additionally, the CAP asked that the CMS “work with the Healthcare Common Procedure Coding System (HCPCS) group to modify the description of the two CAR T-cell Q codes, Q2041, and Q2042, to separate the cell collection and cell processing services from the product itself.” This would create consistency for these physician services with other coding and billing practices and further make the CMS data available to set future payment rates.

On August 4, the CMS had released the Proposed 2021 Hospital Outpatient Prospective Payment System & Ambulatory Surgical Center regulation. The CAP’s letter to the CMS followed an analysis and review of the proposed regulation by the CAP and its experts on payment policy.

Attended the Advocacy Town Hall during CAP20? Then test your CAP Advocacy knowledge with the Advocacy news quiz. See how you compare against your fellow CAP members’ by taking this month’s quiz.

Take the October news quiz