Advocacy Update

Read the Advocacy Update

February 2, 2021

In this Issue:

CAP Responds to White House COVID-19 Plan, Outlines Pathologists’ Priorities

The CAP outlined its priorities to fight the COVID-19 pandemic following the release of the White House’s National Strategy for the COVID-19 Response and Pandemic Preparedness. The CAP has engaged with the new Biden administration as its plan to leverage the federal government to counter the current pandemic has taken shape, especially those elements of the new strategy concerning diagnostic testing.

In a January 27 letter the CAP reviewed issues throughout the testing process, in addition to problems with obtaining testing supplies, continued access to services, and the financial implications of the pandemic on laboratories. The CAP also responded to the new administration’s public health efforts, health care disparities, and global health security. Further, the CAP noted it looks forward to opportunities to engage with administrative officials to help inform health care policy decisions.

“As pathologists are the experts on medical diagnoses, pathologists share your desire to provide greater access to COVID-19 testing, and we must also be part of the public policy decision-making process,” said CAP President Patrick Godbey, MD, FCAP. “Specifically, our expertise can help address needed COVID-19 coverage and testing improvements, supply chain issues, required regulatory action, and the economics of laboratory medicine that ensure continued access to necessary services. For questions about the testing process, the College of American Pathologists can help provide the answers. Together, we will effectively combat this pandemic.”

On COVID-19 testing and supply shortages, the CAP welcomed the Biden administration’s plans to improve the supply chain. The CAP further encouraged the federal government to improve transparency, coordination, and management of testing supplies that laboratories need.

The CAP also requested that the government cover multiplex polymerase chain reaction (PCR) respiratory viral panel (RVP) tests. Many respiratory pathogens present similarly in patients and it is difficult to differentiate between influenza, coronavirus, rhinoviruses, and many other pathogens without accurate testing. Ensuring rapid results with uniform coverage policies is essential to triaging patients and minimizing disease transmission.

Final Medicare Medical Device Coverage Policy Includes Changes Sought by CAP

On January 12, the Centers for Medicare & Medicaid Services (CMS) issued its final regulation Medicare Coverage of Innovative Technology and Definition of “reasonable and necessary.” At the CAP’s urging, this final regulation established a Medicare coverage pathway to provide Medicare beneficiaries with faster access to new, innovative medical devices designated as a breakthrough by the Food and Drug Administration (FDA). The CAP sought Medicare coverage that would not complicate or circumvent the current coverage determination process.

The Medicare Coverage of Innovative Technology pathway will result in up to four years of national Medicare coverage starting on the date of FDA market authorization or a manufacturer date chosen within two years thereafter. This rule also implements regulatory standards to make reasonable and necessary determinations for items and services that are furnished under Part A and Part B. The regulations are effective March 15, 2021.

Reasonable and Necessary

The regulation finalized the term “reasonable and necessary” based on the factors currently found in the Medicare Program Integrity Manual. Further, for national and local coverage determinations, which have insufficient evidence to meet the long-standing appropriateness criteria, the CMS will extend Medicare coverage to the extent of how the majority of commercial insurers cover the item or services. Because of CAP advocacy to ensure adequate stakeholder engagement on the standards, the CMS will establish the methodology by which commercial insurers’ policies are determined.

The CAP had urged the CMS to ensure that the new Medicare coverage decisions will be by health experts through a transparent process based on medical evidence. In the November 2 letter, the CAP supported the CMS’ proposal to classify the existing coverage determination policy definition as reasonable, including the proposed modification. For more information on this regulation, check out the CMS Fact Sheet.

Bipartisan House Lawmakers Introduce Bill that Would Delay Medicare Budget Sequester

To relieve the financial burden of the COVID-19 pandemic on physicians, a bipartisan group of House lawmakers has introduced legislation to suspend a 2% across-the-board Medicare budget sequester for the duration of the COVID-19 public health emergency. The CAP has supported similar efforts over the past year to stop Medicare cuts and protect the value of pathology services. Without additional action, the 2% cut will go into effect on April 1, 2021.

Reps. Brad Schneider (D-IL) and David McKinley (R-WV) introduced the Medicare Sequester COVID Moratorium Act on January 29. Previously, Congress postponed the budget sequester until March 31 in its large spending bill enacted during the final days of 2020. A 2021 moratorium on the budget sequester is being championed by the American Medical Association and other physician associations representing specialties like the CAP.

New Grassroots Advocacy Learning Program Outlines the Fundamentals of the Legislative Process

PathNET, the CAP's grassroots advocacy network, has released a new online interactive course, Grassroots Advocacy: How to Get Involved, to help CAP members learn the fundamentals of the legislative process through a series of self-guided tutorials. This online course will allow pathologists to become more familiar with how Congress drafts and enacts legislation. The modules include definitions of health policy terms, provides an overview of the legislative process, and details current health care policy issues pathologists are facing.

Pathologists have a key role in the delivery of health care and with the new Congress it is important that CAP members are aware of the issues that may impact their profession and ways they can become involved. PathNET designed this tool to provide participants with the core fundamentals to be an effective advocate, as well as provide the resources for the more seasoned advocate.

The learning course also details the many grassroots activities pathologists can get involved in and provides the confidence pathologists seek to be effective advocates because it has been explicitly developed for pathologists. Check out the free course to also learn how to become involved with PathNET. Please contact if you have any questions about the course.

The CAP Wants to Know How COVID-19 Impacted Your Practice

Help the CAP by completing a survey about how the COVID-19 pandemic has impacted your practice. Data from this survey is critical informing CAP leaders, policymakers, and government regulators of the economic and personal challenges that COVID-19 presented to pathologists.

The CAP is surveying all board-certified pathologists until February 9 to see the economic and testing impact from the COVID-19 pandemic. All board-certified pathologists, including CAP members, should have received an email on January 27 to participate in the survey. Participation is vital as the CAP can then fully understand the gravity of COVID-19 on laboratories and testing. All participants will receive a $5 Amazon gift card. The CAP recognizes the value of your time and privacy, and your information will be treated as confidential and will not be associated with you or with your practice/group.

Breaking Advocacy News? Check out the Advocacy Twitter Channel

Want up to the minute CAP Advocacy news? Then follow us on twitter at 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.

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New Month, New Advocacy News Quiz

It's February and that means a new Advocacy News Quiz. Last month, over 60 pathologists take the quiz. See how you compare against your fellow CAP members’ in the February News Quiz.

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