Advocacy Update

Read the Latest Issue of Advocacy Update

• CAP Survey of Laboratories Finds COVID-19 Testing Challenges, Supply Shortages
• CAP Engages with Congress on Next Iteration of ‘Cures 2.0’ Landmark Legislation
• CAP Meets With MedPAC as Commission Studies Improve PAMA Data Collection Accuracy
• SBA Extends Deadline To Return Funds for PPP Loans
• HHS Extends Deadline For Providers to Accept Funding
• Ohio Pathologists, CAP Oppose Out-Of-Network Legislation
• Want COVID-19 Breaking Advocacy News? Follow the Advocacy Twitter Channel
• Take a Break With The May Advocacy News Quiz

With a need for quantitative information on how COVID-19 is affecting laboratories, the CAP surveyed laboratory directors of accredited laboratories nationwide regarding the rate of COVID-19 testing, critical barriers to expanding testing, and the impact on pathologists. On May 6, the CAP published results confirming that while clinical laboratories are expanding testing, over 60% of laboratory directors report difficulties in obtaining critical supplies needed to conduct COVID-19 testing.

According to the survey, nearly 60% of CAP-accredited laboratories nationwide are providing COVID-19 testing. Nearly 80% of those laboratories providing COVID-19 tests reported that they have the capacity for more testing than their current levels. However, laboratory directors do expect their COVID-19 testing volume to increase by about 40% over the next two weeks.

However, the survey documented that laboratories face substantial challenges in obtaining supplies necessary for COVID-19 testing. For instance:

• 69% reported difficulty in acquiring test kits to conduct COVID-19 testing.
• 66% reported difficulty in acquiring nasopharyngeal swabs.
• 62% reported difficulty in acquiring viral transport media/universal transport media to conduct the tests.

Laboratory directors surveyed also reported increased stress on pathologists and laboratory professionals as a result of long work hours, leading to an increase in burnout. Additionally, all laboratories are facing substantial financial pressures, regardless of whether they are providing COVID-19 testing. Nearly all laboratories surveyed reported significant losses in revenues, including the need to furlough employees in some cases.

The CAP’s survey is the first to gather frontline data on the burdens pathologists are facing in responding to the national emergency. The CAP surveyed 3,784 laboratory directors from CAP-accredited laboratories nationwide and received 434 responses in seven days for an 11.5 % response rate. About 65% of the respondents were from hospital-based laboratories. Of the respondents, 43% were based in nonacademic hospitals, and 22% were based in academic hospitals. The CAP’s survey generated media in Chicago ABC 7 and other media outlets.

The CAP discussed its priorities regarding national testing and response strategy for future pandemics in a May 11 letter to congressional lawmakers who released a concept paper that will be the foundation for new legislation focused on medical research and new treatments. Dubbed “Cures 2.0,” the concept paper would establish themes for a legislative framework that would build upon the 21st Century Cures Act that passed in 2016.

“As Congress works on further COVID-19 and Cures 2.0 legislation, we urge you to consider our recommendations, including the need for regulatory flexibility, quick development of and appropriate pricing and coverage for diagnostic testing, and funds to support testing services and laboratory frontline providers in any comprehensive testing strategy,” the CAP stated in the letter.

While much has been done to improve the nation’s surveillance and testing capabilities during the COVID-19 pandemic, the CAP called for improvements that would provide more flexibility. In addition, new legislation should allow for the quick development of appropriate coverage and pricing for diagnostic testing. Further, funding mechanisms should be in place to support testing services and laboratories.

The CAP supports the establishment of a fund up to $5 billion to support pathology and laboratory frontline providers. This fund would assist pathologists and the laboratories they lead in performing COVID-19 testing services, such as support for personnel, uncompensated testing, capital and supplies, research and development, and other costs associated with testing. The CAP also urged Congress to stop an 8% Medicare cut to pathology services beginning January 1, 2021. This cut will exacerbate the financial instability of pathology practices that have been greatly impacted by the pandemic and the resulting economic downturn.

Read more by downloading the CAP’s letter.

On May 4, CAP leadership met with the Medicare Payment Advisory Commission (MedPAC) to discuss concerns with the Protecting Access to Medicare Act (PAMA) and reimbursement rates for tests on the clinical laboratory fee schedule (CLFS). The MedPAC is an independent federal group that periodically produces reports to Congress on Medicare program recommendations. The LAB Act that passed in 2019 as a part of federal spending legislation mandated that MedPAC report on the implementation of PAMA and provide recommendations for reform. In light of the mandated study, the CAP urged MedPAC to improve how data is collected and validated under PAMA to ensure an accurate, market-based payment system for laboratories.

Given the integral roles pathologists play in directing clinical laboratories, overseeing the quality and appropriateness of laboratory testing in their medical communities, and developing laboratory tests, the CAP and its members have a significant stake in the implementation of PAMA. During the meeting with MedPAC, the CAP discussed ways to improve PAMA to ensure more accurate PAMA rates and continued access to laboratory tests for Medicare patients. During the meeting the CAP discussed the importance of:

• Ensuring that the private payer data accurately represents all segments of the market
• Ensuring appropriate private payor rates
• Ensuring quality and validation of data collected by the Centers for Medicare & Medicaid Services (CMS)

The CAP will continue to meet with federal groups to ensure accurate PAMA rates and continued access to laboratory tests for Medicare patients.

The Coronavirus Aid, Relief, and Economic Security (CARES) Act created more than $350 billion in emergency aid for small businesses, including pathology practices of 500 employees or less, during the COVID-19 national emergency and economic downturn. A key aspect of the CARES Act relief package is the now-well-known Paycheck Protection Program (PPP) administered by the Small Business Administration (SBA). On May 5 the SBA extended the deadline to pay back PPP loans to May 14.

On May 5, the SBA issued a new FAQ 43, extending the deadline for this safe harbor until May 14. The FAQ also states that the SBA intends to provide additional guidance on how it will review the necessity certification prior to May 14. Accordingly, borrowers considering repaying the loan should strongly consider doing so prior to May 14 but may wish to wait for additional guidance.

The PPP loan application requires that applicants certify that the “current economic uncertainty makes this loan request necessary to support the ongoing operations of the Applicant.” The CAP recommends that pathology practices in need of financial assistance should apply for SBA loans.

Previously, the SBA loans informed that any borrower that applied for a PPP loan prior to the issuance of FAQ 31 on April 23 would be deemed to have made the necessary certification in good faith if the loan is repaid in full by May 7.

On April 3, the CAP outlined and provided links to resources in FAQs about the SBA loans. These loans are available on a first-come, first-serve basis and are open for application until June 30. Provide us with your feedback and additional questions about these financial programs by emailing the CAP at smallbusiness@cap.org.

The Department of Health and Human Services (HHS) extended the deadline for providers to attest to receipt of Provider Relief Fund payment. Providers will now have 45 days instead of 30 to attest and accept the terms and conditions, or return the funding. The 45 days starts from the date the payment is received. Attestation is available online at https://covid19.linkhealth.com/#/step/1.

The CAP developed a FAQ guide for members with questions related to the Provider Relief Fund payments.

Starting April 1, an initial $30 billion from the Provider Relief Fund was allocated to health care providers based on Medicare fee-for-service payments in 2019. On April 24, a second wave of funds was available to reconcile the initial payment, if any, so that the provider ultimately receives a proportion of a provider’s 2018 patient revenue. Only Medicare providers who have already received a payment from the Provider Relief Fund will be eligible to apply for this additional wave of funds.

The CARES Act, enacted on March 27, allocated $100 billion for a Provider Relief Fund to help physicians and other health care entities that are responding to the coronavirus pandemic. The Paycheck Protection Program and Health Care Enhancement Act provides another $75 billion for the fund.

The Ohio Society of Pathologists (OSP), the Ohio State Medical Association (OSMA), and the CAP are strongly opposed to House Bill 388, a measure designed to address out-of-network billing, but which the groups say will unfairly punish out-of-network physicians.

The measure, which is under consideration in the Ohio State House Finance Committee, would prohibit out-of-network providers from billing covered individuals the difference between the out-of-network reimbursement rate and the provider’s charge. However, the provider can inform the patient that they are not in-network and tell them in advance of a good faith estimate of the cost of the services. It also would establish a payment mechanism for health insurers to reimburse out-of-network providers when services are provided to a covered person at an in-network facility.

Under the bill, unless the individual provider wishes to negotiate reimbursement with the insurer, the reimbursement would be the greater of:

• The amount paid to in-network providers
• The amount for the service calculated using the same method the health benefit plan generally uses to determine payments for out-of-network services, such as usual, customary and reasonable, or
• The amount that would be paid under the Medicare program

All three methods would exclude any in-network cost-sharing.

In a May 4 letter to the committee, OSP President Sean Kirby, MD, FCAP, said that consideration of this legislation during the current COVID-19 public health emergency “shows a disregard for patient access to physician care and, therefore, the future economic viability of hospital-based physician health care services.” 

Additionally, two states – Maine and Virginia – recently enacted broad out-of-network anti-balance billing laws that were supported by the physician community and could be used as a model in Ohio, he added.

The OSP, OSMA, and the CAP urged Ohio lawmakers to enact legislation that gives patients strong protections against surprise bills without threatening access to quality care. The CAP will continue to monitor developments on this issue.

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