Advocacy Update

Read the Latest Issue of Advocacy Update

March 3, 2020

In This Issue:

New FDA Policy to Expedite Availability of Diagnostics to Test COVID-19

The US Food and Drug Administration (FDA) issued guidance to expand testing capacity by facilitating the development of molecular SARS-CoV-2 diagnostic assays (coronavirus). The policy described in the guidance published on February 29 applies to laboratories certified to perform high-complexity testing under CLIA, that comply with CLIA requirements, that have developed and are using their own validated diagnostic test, and are pursuing an Emergency Use Authorization (EUA). The FDA has additional updates for EUA submissions on its website.

Clinical laboratories should contact their state health departments for guidance if they have a suspected COVID-19 case specimen. Clinical laboratories should NOT attempt viral isolation from specimens collected from COVID-19 persons under investigation (PUIs). For interim guidelines for collecting, handling, and testing clinical specimens from PUIs for COVID-19, please see the CDC COVID-19 website.

The CAP is working with federal agencies to monitor the outbreak and laboratory capacity to provide testing. Check the latest news section of for more updates on the coronavirus.

President, Congress Debates Funding Resources for COVID-19

The Trump administration asked Congress to appropriate $2.5 billion to fight COVID-19. In total, the administration is seeking $1.25 billion in new funding, and the request relies on re-programming existing funds from other agencies and programs to account for the rest.

However, the request was met with immediate resistance from Republican and Democratic leaders in the House of Representatives and the Senate. Congressional leaders argued that the budget request is not adequate to manage the potential outbreak, and are concerned that the request did not have sufficient details on how the money would be spent.

In the administration’s proposal, more than $1 billion would fund vaccine development, and the other funds would support stockpiling protective equipment. While the money is meant to be spent in 2020, the request would allow spending to continue through 2021, if needed. The president also indicated that the administration would increase the funding if Congress was willing to allocate more money.

The CAP will monitor the issue and report on future updates.

CAP Urges CMS to Correct Flawed Pricing Data to Improve Pathology Practice Expense Values

The CAP urged the Centers for Medicare & Medicaid Services (CMS) to correct prices used to calculate the practice expense value of pathology services. The CMS engaged with an independent contractor to update prices for all medical equipment and supplies, resulting in pricing errors impacting practice expense values for pathology services. As a result, the CAP worked with the CMS to provide updated information on the costs for medical equipment and supplies used in pathology and laboratory services to calculate the practice expense value. This effort ensures the accurate value for pathology services for the proposed 2021 Medicare Physician Fee Schedule.

Over the years, the CAP has been instrumental in increasing Medicare payment for pathology services through this advocacy effort to correct errors affecting Medicare reimbursements for pathology services. For instance, in its 2020 Medicare physician fee schedule, the CMS updated 36 direct practice expense supplies and equipment prices, adding $30 million to Medicare payment to pathology services. Twenty-four of these prices increases are due to the direct work of the CAP’s engagement to correct previous errors by the CMS. These prices largely account for the technical component of many pathology services and are also reflected in global payment rates.

The CAP submitted once again to the CMS current accurate pricing data to correct practice expense values, as it continuously educates the agency on the complexity of laboratory and pathology services. The CAP is the only pathology member group that directly advocates fair pay for the value pathologists provide with the CMS—actively representing pathologists' interests in nearly every payment-related policy discussion.

The CAP continues to engage with the CMS on this issue.

Dr. Foster: How Laboratory Tours Show Policymakers the Impact of Pathology

Periodically Advocacy Update features a CAP member who is a champion for pathology in Washington through our grassroots programs. Recently Advocacy Update caught up with Matthew Foster, MD, FCAP, who part of the Pathology Consultants of Central Virginia and the Medical Director of the Cancer Service line at the Alan B. Pearson Regional Cancer Center in Lynchburg, Virginia. Dr. Foster is also the Vice-Chair of the CAP Federal and State Affairs Committee.

Matthew Foster, MD, FCAP looks on as Joni Look, Lead Medical Laboratory Technician, shows the Honorable Ben Cline (R-VA) how a diagnostic test is completed.

Recently, Dr. Foster hosted a laboratory tour for Rep. Ben Cline (R-VA). Dr. Foster knew that a laboratory tour provided hands-on opportunity to familiarize policymakers with the essential role pathologists play in health care. The laboratory tour also provided Rep. Cline a critical understanding of what pathologists do and how changes to the health system will impact their ability to deliver quality care and accurate diagnoses to their patients.

During the tour, Dr. Foster had an opportunity to thank Rep. Cline on his support in the surprise billing policy debate and even discussed the important aspects of batch codes and arbitration without a threshold. This unparalleled access to a policymaker, while they see a laboratory in action, left quite an impression on Rep. Cline, who saw “the importance of pathology and laboratory medicine and having rapid access to care close to home,” according to Dr. Foster.

Rep. Cline sits on the House Education and Labor Committee, which released its own version of surprise billing legislation that the CAP opposes. Rep. Cline championed the voices of patients and physicians and voted no to release the bill out of committee. The CAP appreciates the support of Rep. Cline.

Laboratory tours are also an opportunity for you to build a relationship with your Member of Congress. Learn more about scheduling a laboratory tour.

CAP’s Private Sector Advocacy

The CAP champions policies that protect access to pathology services for patients, and fights against overburdening pathologists with administrative requirements with private payors and health insurance plans.

For instance, the CAP opposed a Horizon BlueCross BlueShield of New Jersey reimbursement policy that imposed limits on maximum daily units for surgical pathology and microscopic examination services. In a November 22 letter from the CAP to Horizon BlueCross BlueShield of New Jersey, we urged the insurer to reverse its restrictive policy and requested a meeting to discuss this issue further. Then in January of 2020, Horizon notified the CAP it would be revising the biopsy limits and policy.

Since April 2019, the CAP has engaged with Anthem Blue Cross and Blue Shield on policy regarding fee schedule changes to pathology services in several states. Given the serious impact on pathologists, CAP leaders pressed Anthem to reverse fee cuts to pathologists.

Read more on how CAP efforts promote favorable private payer coverage, payment, and other policies.

Breaking Advocacy News? Check out the Advocacy Twitter Channel

Want up to the minute CAP Advocacy news? Then follow CAPDCAdvocacy, where you will be the first to know about CAP Advocacy wins, see your fellow members engage with Congressional leaders on key policies affecting the practice of pathology and, of course, breaking Advocacy news.

Check it out and follow it today.

New Month, New Advocacy News Quiz

It’s a new month, and that means a new Advocacy news quiz. See how you compare against your fellow CAP members’ savvy advocacy knowledge. And then share your results on social media. Take the March news quiz today.