Advocacy Update

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Pathology practices should apply early for new small business assistance loans as the funds are capped and loans are awarded on first-come-first-serve basis. Last week, the Paycheck Protection Program federal assistance program began offering loans to small businesses. The Coronavirus Aid, Relief, and Economic Security (CARES) Act created more than $350 billion in emergency aid for small businesses during the COVID-19 national emergency and economic downturn.

Published news reports stated some financial institutions were not immediately ready to accept loan applications or were initially limiting inquiries to those with an established financial relationship. To be eligible for CARES Act funds, the government defined a small business as a company with less than 500 employees.

The CAP compiled questions and answers regarding what is available to pathologists and their practices/laboratories from the CARES Act and other assistance programs from the federal government.

Tell Us Your Experiences with SBA Loans

Provide us with your feedback and additional questions about these financial programs by emailing the CAP at

Read our FAQs on small business assistance programs.

The American Medical Association (AMA), the CAP, and several other medical societies are requesting immediate financial assistance for physicians across the country who diagnose and treat patients with the novel coronavirus. Specifically, in a letter from the AMA signed by dozens of associations including the CAP, physicians are urging the Department of Health and Human Services (HHS) to provide one month of revenue to each physician and other health professionals enrolled in Medicare or Medicaid to account for financial loses and non-reimbursable expenses, the groups said in the letter to HHS Secretary Alex Azar.

The AMA notes the recently enacted CARES Act permits the Secretary of HHS to provide immediate financial relief by issuing funds via Medicare Administrative Contractors. “Physicians are continuing to put their patients’ needs first to combat this unprecedented public health emergency,” the letter said. “We urge you to support them against financial peril while they put their lives and businesses at risk.”

With the CMS expanding its accelerated and advance payment program for Medicare participating physicians, the CAP is providing its members with direct links to their Medicare Administrative Contractor (MAC) and request forms to apply for emergency funding.

The accelerated and advance Medicare-payments provide emergency funds and address cashflow issues based on historical payments when there is a disruption in claims submission or processing. For COVID-19, the CMS expanded the program for all Medicare providers throughout the country during the public health emergency.

The table below shows contains links to MACs and advanced payment program request forms. If you don’t know which contractor is your MAC, use this map from the CMS.

The COVID-19 pandemic has caused unprecedented challenges to the US blood supply. In response, the Food and Drug Administration (FDA) issued guidance to meet an urgent need for blood and blood components.

On April 2, the FDA revised recommendations in several guidance regarding blood donor eligibility. These changes took effect immediately and will remain as policy until the pandemic ends. The revised recommendations to encourage more blood donations include:

The FDA is also providing notice of alternatives to certain requirements regarding blood donor eligibility. The FDA expects that the alternative procedures will improve the availability of blood and blood components while helping to ensure adequate protections for donor health and maintaining a safe blood supply for patients.

Over 1,000 CAP Members Successfully Submit MIPS Data, Will Earn Bonuses with Pathologists Quality Registry

More than 1,000 pathologists from nearly 100 practices completed their 2019 performance year reporting for Medicare’s Merit-based Incentive Payment System (MIPS) by utilizing the Pathologists Quality Registry and its top-tier staff expertise. Our expectation is that this success will result in all Pathologists Quality Registry participants receiving increased Medicare reimbursements next year for their efforts.

The partnership between the Pathologists Quality Registry participants and the CAP is one that can be emulated by other pathology practices to ensure their pathologists have the best qualified clinical data registry for continuous quality improvement and demonstrating their value in MIPS. Pathologists Quality Registry enrollment is currently open for Medicare’s 2020 MIPS. CAP members can also send their questions about the MIPS program to the CAP’s experts email address:

CMS Reopens Hardship Application

For pathologists and other physicians and clinicians who don’t use the CAP’s registry and are unable to submit 2019 MIPS data due to the COVID-19 pandemic, the Centers for Medicare & Medicaid Services (CMS) announced that the MIPS automatic extreme and uncontrollable circumstances policy will apply to anyone who cannot meet an April 30 deadline.

The CMS states if you are a MIPS eligible clinician and do not submit any MIPS data by April 30, 2020, you won’t need to take any additional action to qualify for the automatic extreme and uncontrollable circumstances policy. You will be automatically identified and will receive a neutral payment adjustment for the 2021 MIPS payment year.

The CMS has updated its QPP Participation Status Tool so eligible clinicians can see if the policy has been automatically applied.

The CMS also reopened its MIPS extreme and uncontrollable circumstances application for individuals, groups, and virtual groups. Who should submit an application?

  • Individual clinicians who started, but are unable to complete, their MIPS data submission
  • Groups that started, but are unable to complete, their data submission
  • Virtual groups that are unable to start or complete their data submission.

An application submitted between April 3 and April 30, 2020, citing COVID-19, will override any previous data submission.

The Trump administration proposed guidance for future federal regulation of artificial intelligence (AI) used in medicine. The proposed guidance would promote private sector applications of AI that are safe and fair, while also pushing back against stricter regulations. In response, the CAP warned the Trump administration that “promoting AI adoption in health care does not adequately address the practical difficulties of controlling actions of autonomous machines,” as stated in the March 13 comment letter.

The CAP asked the Trump administration to proceed with caution with respect to the unknown factors of AI in health care when creating these policies. For instance, regarding the impact of AI in pathology and laboratory medicine, the CAP urged the administration to “balance the advancement in technology and innovation with patient safety and regulatory oversight. Regulations for AI will need to ensure the appropriate levels of safety can be reliably determined,” the CAP said in its letter.

The CAP also urged for transparency when developing these AI guidelines as it executes decision-making with continued updates of those autonomous systems’ potential risks and benefits. Additionally, the CAP insisted that awareness of when patients’ data would be used in AI programming is protected, regardless of who is developing the AI (public vs private entities), among other concerns.

Previously, the CAP advocated for a risk-based approach to the FDA to ensure that any AI devices technology is safe because of the impact on the many uses in pathology and laboratory medicine, especially in next-generation sequencing and digital pathology.

The CAP asked the administration to create these new AI guiding principles to reflect the same regulatory approach strategy as CLIA for measuring and verifying performance and calibration. To meet this strategic approach, the CAP encouraged the administration to include these principles:

  • Validate prior to use with documentation kept of such validation with each new and updated implementation of AI
  • Check for potential or actual continuation or exacerbations of bias, prejudice, inequality, risk
  • Verify that it performs as intended
  • Check for spurious illogical associations that could increase risk, bias, prejudice, inequality, etc.

Earlier this year, the White House drafted a memorandum on the Guidance for Regulation of Artificial Intelligence Applications.

On March 31, Washington State Governor Jay Inslee signed into law legislation (SB 5601) which was supported by the Washington State Society of Pathologists (WSSP) and the CAP, regulating health and laboratory benefit management programs. Specially the new definition of "laboratory benefit management" in the legislation was crafted by the CAP with the support from the WSSP.

The Washington state law is the first time that a state has directly regulated, using this definition, this aspect of insurance program control over the utilization of pathology and laboratory services. Broadly, the legislation requires the application and state registration of such insurance programs by the Department of Insurance, including disclosure by the regulated program of any potential conflict of interest in the form of a "controlling interest" of a laboratory by such benefit management program.

The legislation established Department of Insurance state oversight regarding program conduct, including purview over complaints. The bill was unanimously passed by both state legislative houses in early March.

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