Advocacy Update

Read the Latest Issue of Advocacy Update

• House Passes CAP Backed Paycheck Protection Program Flexibility Act of 2020
• HHS Announces 45-Day Provider Relief Deadline Extension
• Pathologists Have Until June 3 To Receive Additional Relief Funds
• CDC Alert: Molecular Transport Media and Cyanide Gas
• FDA Issues EUA for At Home COVID-19 Testing Kits
• HHS Releases National Testing Strategy Plan
• CAP To Provide Pivotal CLIA Recommendations for New Laboratory Technologies
• Hematologists, ED Physicians Create COVID-19 Resource for Sickle Cell Patients
• New Month, New Advocacy News Quiz

The CAP applauded that the House passed HR 7010, the Paycheck Protection Program Flexibility Act of 2020, as it provides flexibility to use funds beyond an initial eight-week timeframe. The bipartisan bill would modify certain provisions of the paycheck protection program, including those related to the forgiveness of loans and the ability to defer payroll taxes. The House vote was nearly unanimous at 417-1.

If enacted, the bill would expand the terms of the loans from the Paycheck Protection Program, created by the $2.2 trillion Coronavirus Aid, Relief, and Economic Security Act (CARES) relief package. The bill would give recipients additional opportunities to repay or seek loan forgiveness. “We applaud the efforts of Rep. Roy Chip for leading this bipartisan bill with Reps. Dean Phillips, Tom Emmer, and Fred Upton. Pathologists appreciate their work, and the work of the Ways and Means Small Business Subcommittee, as pathologists have worked tirelessly to bring new COVID-19 testing to communities across the United States as regular revenues from pathology and laboratory services ceased,” the CAP said in support of the bill in a May 27 statement.

The legislation is intended to make loans more accessible under the program by making its terms more flexible. For instance, the bill would give small businesses, like pathology practices of less than 500 people, more time to use emergency loans under the program by extending the eight-week period in which they must use the money to qualify for loan forgiveness to 24 weeks.

The bill would also allow small businesses to spend more of the loans on non-payroll costs. The current terms of the loans require recipients to use 75% of the funds on payroll and up to 25% on other costs to qualify for loan forgiveness. But the legislation would change the ratio to at least 60% on payroll and up to 40% on rent, overhead, and other costs.

However, the Senate still needs to pass legislation to implement the changes. The Senate version is largely similar to what the House has passed, but it only would extend the timeframe for small businesses to spend the funds to 16 weeks instead of 24.

The Department of Health and Human Services (HHS) announced a 45-day deadline extension for providers receiving payments from the Provider Relief Fund to accept the program’s terms and conditions. This announcement means providers have been granted 90 days from the date they received a payment to accept the terms and conditions or return the funds. Not returning the payment within 90 days of receipt will be viewed as acceptance of the terms and conditions.

The CAP has developed a guide for pathologists with questions about the Provider Relief Fund. View the CAP guide online here. View the latest version of HHS’s FAQ document online here (updated 5/29/20).

The CARES Act allocated $100 billion for a Provider Relief Fund to help physicians and other health care entities that are responding to the coronavirus pandemic. Of that, $50 billion is allocated for general distribution to Medicare facilities and providers impacted by COVID-19, based on eligible providers' net patient revenue. The Paycheck Protection Program and Health Care Enhancement Act added another $75 billion to the fund.

The CAP has additional resources for pathologists and their practices facing financial difficulty on our COVID-19 webpage. Other questions or concerns can be emailed to smallbusiness@cap.org.

The HHS published a reminder that eligible pathologists and other physicians have until June 3 to accept the terms and conditions, as mentioned in the previous story, and submit their revenue information for the Provider Relief Fund. Additionally, providers who have automatically received an additional General Distribution payment before 5 PM on April 24 must provide the HHS with an accounting of their annual revenues by submitting tax forms or financial statements and agree to the program terms and conditions by June 3.

If providers do not submit their revenue information by June 3, they will no longer be eligible to receive potential additional funding from the $50 billion General Distribution.

The CARES Act allocated $100 billion for a Provider Relief Fund to help physicians responding to the coronavirus pandemic. Of that, $50 billion of the Provider Relief Fund is allocated for general distribution to Medicare facilities and providers impacted by COVID-19, based on eligible providers' net patient revenue. This funding supports health care-related expenses or lost revenue attributable to COVID-19 and ensures uninsured Americans can get treatment for COVID-19.

For questions related to the HHS’s Provider Relief Fund, see the CAP’s guide.

The Centers for Disease Control and Prevention (CDC) issued a warning on May 30 that stated PrimeStore Molecular Transport Media (MTM) contains guanidine thiocyanate, which produces a dangerous chemical reaction that releases cyanide gas when exposed to bleach (sodium hypochlorite).

The CDC warned laboratories to not use PrimeStore MTM with platforms that include a disinfecting step that uses bleach (eg, Hologic Panther, Panther Fusion Systems).

Other MTM may contain guanidine thiocyanate, and ingredients in MTM may not be listed on individual vials, the CDC said. If samples are received in unfamiliar transport media, laboratories should make sure the media does not contain guanidine thiocyanate before processing the samples in a system that uses bleach.

On May 29, the Food and Drug Administration (FDA) released a voluntary Emergency Use Authorization (EUA) template for COVID-19 at-home sample collection kits. The template provides information on what data clinical laboratories and commercial diagnostic test makers should submit to support the EUA submission for home COVID-19 collection devices, such as nasal or saliva swabs. The template does not cover non-prescription home collection devices or over-the-counter COVID-19 tests.

The FDA has authorized two at-home test kits, Everlywell’s standalone at-home collection test kit and LetsGetChecked’s kit, to be used with the company’s COVID-19 test platform.

The FDA will authorize more at-home collection kits, including for OTC use, but still has concerns about test accuracy and reliability.

On May 25, the HHS released a national COVID-19 testing plan holding states responsible for planning and executing COVID-19 testing while providing some supplies needed for the tests. The national testing plan, which was required by the Paycheck Protection Program and Health Care Enhancement Act, codified the current testing strategy that is decentralized and allows the states to establish their COVID-19 testing goals.

The national testing strategy said that, “the current existing testing capacity is sufficient to contain the outbreak.” Additionally, the national strategy provides information about diagnostic technologies, platforms, and inventory that states can utilize to develop flexible, adaptable, and robust testing plans.

The testing strategy further emphasized that the federal government should be considered “the supplier of last resort” and that states should develop their testing plans. The federal government plans to distribute some testing supplies to tests, including swabs and viral transport media, and to store test kits in the strategic national stockpile.

To increase national testing capacity, the focus must be on the development and production of commercially available diagnostic assays and the myriad of components necessary to support the testing enterprise, including instruments, supplies, PPE for health care, and laboratory personnel involved in sample collection and testing. The HHS would achieve increased capacity through existing coordination efforts with the private sector, such as the federal government Laboratory Diagnostic Testing Task Force, to gain a better understanding of supply chain challenges and projected inventory.

To respond to future pandemics, the HHS will develop a secure data collection and utilization system; enhanced domestic production and supply chain management capabilities for testing supplies and reagents; and develop public-private partnerships to enhance testing capacity.

Elements from the national testing strategy have been advocated for by a broad array of health care organizations and health care experts including the American Medical Association, American Hospital Association, the CAP and many other organizations within the laboratory community such as the American Clinical Laboratory Association, Association of Public Health Laboratories, and the American Society for Clinical Pathology.

The CAP remains engaged with the HHS regarding its response to the COVID 19 pandemic. The CAP is committed to working with laboratories to overcome the challenges they are facing by advocating on their behalf in multiple venues, including federal officials in Washington, DC.

The CAP has long advocated for cutting-edge laboratory technology standards. Recently the CDC asked the CAP and others for personnel recommendations and the retention of next-generation sequencing data in clinical and public health laboratories. As a leader in laboratory medicine, the CAP will provide guidance to the CDC on the qualifications of personnel performing bioinformatics activities, storage and retention of next-generation sequencing (NGS) data files, and maintenance of sequence analysis software.

Clinical laboratory testing technology has advanced since CLIA regulations were first implemented. Additionally, NGS technology requires a specialized skill set to provide accurate patient care.

The CAP has worked with the Clinical Laboratory Improvement Advisory Committee (CLIAC) to ensure regulations keep up with new and emerging technologies. As an advisory committee, CLIAC offers recommendations and guidance to federal oversight agencies to improve clinical laboratory quality and laboratory medicine practice. In 2019, the CAP provided its comments for workgroup summary reports on next-generation sequencing (NGS), CLIA personnel regulations, and a nontraditional testing workflow model.

In November 2019, the CAP provided testimony that CLIA should be modified to address emerging technologies and roles that support them. At the meeting the CAP recommended CLIA add the following:

• CLIA certification should be required of any organization performing portions of the testing process, including the application of proprietary or complex algorithmic interpretations of a clinical laboratory test that generates an individual result, whether or not that organization receives or processes physical specimens.
• Bioinformaticists personnel requirements are needed for clinical and public health laboratories since these roles need specialized expertise.

The CAP will work with its committees to provide recommendations by the July 14 deadline.

In the light in the COVID-19 pandemic, the American Society of Hematology (ASH) released a checklist to assist in the evaluation of individuals with sickle cell disease (SCD) with COVID-19 symptoms and/or complications of SCD. The checklist was developed by hematologists and emergency department physicians who have expertise with SCD. As a member of the Sickle Cell Disease Alliance, the CAP wants this resource available to members during this national emergency. The resource is available on ASH’s website, Frequently Asked Clinical Questions on COVID-19 and SCD, and links to other SCD specific resources.

It’s a new month and the CAP has a new Advocacy News Quiz. Last month, over 100 pathologists took the quiz. See how you compare against your fellow CAP members’ in the June News Quiz. Take the June news quiz.