Advocacy Update

Read the Latest Issue of Advocacy Update

• White House Releases Testing Blueprint to Work with States; Outlines Prior Actions
• CAP Calls on Anthem to Stop Cuts to Pathologists
• HHS Releases Additional $20 Billion More in Funds for Physicians
• CMS Suspends Accelerated and Advance Payment Program
• CAP Demands Coverage for Respiratory Viral Panel Tests
• FDA Releases Guidance for Remote Digital Pathology Devices
• FDA Releases Serology Testing for COVID-19
• CT Governor Rescinds Order that Would Have Lowered Pay to Physicians
• Last Week to Take April Advocacy News Quiz

The White House published a “National Testing Blueprint” on April 27 in response to growing criticism regarding availability of testing. The blueprint document outlines three stages, mostly recounting prior actions, but commits to continue to work with the private sector to increase testing and pledges to support the states in their efforts to expand testing.

The majority of the National Testing Blueprint is much more of a status report than a plan of action as its content is devoted to laying out the chronology of multiple actions taken by Congress, the White House, the Food and Drug Administration (FDA), and Centers for Medicare & Medicaid Services (CMS) dating back to January in response to the COVID 19 pandemic. The White House report specifically thanks the American Society of Microbiology for its help, but the chronology of government actions laid out in the report 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.

In the Testing Blueprint, the Trump administration states that to expand the number of testing platforms, the FDA has issued 70 emergency authorizations for new tests, including eight for serological tests, over the last several weeks. As a result, the United States has performed more than 5.4 million tests in less than 45 days. More than 1,000 laboratories accredited by the CAP have worked to bring online tests to diagnose the virus SARS-CoV-2 that causes coronavirus. The CAP has assisted laboratories as needed, for instance, by providing guidance for testing validation, by answering questions received about these tests through the CAP’s laboratory support hotline, and offering a new proficiency testing program for SARS-CoV-2.

The CAP remains engaged with the Trump Administration and Congress regarding its response to the COVID 19 pandemic, including testing and will be reviewing certain elements of the blueprint, such as the reliance on states and how the government plans to address issues concerning testing supplies. As the CAP engages with the administrative officials and federal lawmakers, we will seek input and feedback from laboratory directors, presidents of state pathology societies, and members of the CAP House of Delegates to best inform decisions of policymakers. 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 urged Anthem BlueCross and BlueShield (BCBS) to stop its implementation of the 2019 fee schedule cuts as well as reinstate payments to previous levels where the cuts were implemented. In addition, the CAP emphasized our longstanding policy that the professional services of the pathologist must be recognized.

In an April 17 letter to the insurer, the CAP asked Anthem BCBS to “cease implementation of the announced 2019 fee schedule cuts and where already implemented, reinstate payments to the previous levels.” The CAP outlined how the current national emergency placed pathology practices in jeopardy as the routine anatomic pathology services are not being utilized at their usual demand. Simultaneously, the pandemic has increased the critical demand for laboratory directorship, which are professional services that should be compensated fairly.

The COVID-19 national emergency not only highlights the importance of ensuring access to the usual care of needed pathology and laboratory services, including those of hospital-based pathologists, independent laboratories, and others. The pandemic casts a bright light on the full range of patient services pathologists provide. For example, during the current crisis pathologists have been responsible for developing new test methodologies, approving testing for patient use, and expanding the testing capabilities of the communities to meet emergent needs. Pathologists also assure compliance with all laboratory regulatory and accreditation standards, while preventing overuse or improper application of tests. Therefore, the CAP argued that hindering access to high-quality pathology services through reduced rates or lack of payment for pathology and laboratory services adversely affects patient diagnosis, treatment, and outcome. “Now more than ever, patients and their treating physicians appreciate their reliance on the expertise of pathologists and the availability of appropriate testing.”

Since April 2019, the CAP has worked with Anthem BCBS 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. The CAP argued that the cuts undermine the viability of pathologists’ practices and access to care for pathology services.

The Department of Health and Human Services (HHS) released an additional $20 billion from its Provider Relief Fund to physicians and other providers enrolled in the Medicare program. Previously, an initial $30 billion was allocated to physicians and facilities based on their proportion of Medicare Part A and B fee-for-service spending in 2019.

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 relief funds are payments, not loans, to health care providers, and will not need to be repaid. However, providers must sign an attestation confirming receipt of the funds and agree to the terms and conditions within 30 days of payment. The CARES Act Provider Relief Fund Payment Attestation Portal is online here.

The American Medical Association (AMA) has additional information available about the Provider Relief Fund on its website.

Earlier, the HHS released an initial $30 billion to physicians and other providers. Of the remaining $50 billion, $10 billion will be targeted for distribution to hospitals in areas that have been particularly impacted by the COVID-19 outbreak based on information they provide on the number of ICU beds and admissions for patients with a COVID-19 diagnosis. An additional $10 billion is allocated to rural hospitals and rural health clinics based on their operating expenses, and $400 million is being directed to Indian Health Service facilities.

Some portion of the remaining funds will cover the costs associated with care for uninsured patients with COVID-19. These funds may be claimed beginning April 27 at the HRSA’s website here: https://www.hrsa.gov/coviduninsuredclaim and the reimbursement for the uninsured will be based on Medicare payment rates. Physician services provided to uninsured patients, such as office and emergency visits, including those provided via telehealth, may be reimbursed in this manner.

The Paycheck Protection Program and Health Care Enhancement Act signed into law on April 24, provides an additional $75 billion be distributed to health care providers but details from the HHS on that round of funding is not yet available.

The CAP will provide updated details as the HHS makes them available. More information is available at https://www.hhs.gov/provider-relief/index.html.

On April 27, the Centers for Medicare & Medicaid Services (CMS) announced they will reevaluate the amounts that will be paid under its Accelerated Payment Program and will suspend its Advance Payment Program to Part B suppliers effective immediately. The CMS will not accept any new applications for the Advance Payment Program. According to the CMS, the decision was made in light of direct payments made available through the Department of Health & Human Services’ (HHS) Provider Relief Fund. The CAP has guidance for pathologists regarding other relief programs that are still available to pathologists.

The Coronavirus Aid, Relief, and Economic Security (CARES) Act and the CMS expanded the Accelerated and Advance Payment Program for Medicare-participating physicians to ensure they have resources needed to combat COVID-19. The CMS has paid over $100 billion to health care providers and suppliers through these programs. For Part B suppliers, including doctors, non-physician practitioners, and durable medical equipment suppliers, the CMS approved almost 24,000 applications advancing $40.4 billion in payments. These payments are not a grant, and providers and suppliers are typically required to pay back the funding within one year or less, depending on provider or supplier type.

Funding will continue to be available to hospitals and other health care providers on the front lines of the coronavirus response primarily from the Provider Relief Fund. The HHS recently announced additional details on the allocation of this fund. More information is available at hhs.gov/providerrelief.

The CMS has provided an updated fact sheet on the Accelerated and Advance Payment Program. The CAP can answer questions about these financial programs at smallbusiness@cap.org .

To meet the demand to test for coinfections of other respiratory pathogens, the CAP and several other organizations urged the CMS to provide coverage for multiplex polymerase chain reaction (PCR) respiratory viral panel (RVP) tests during the COVID-19 national emergency.

In an April 28 letter to CMS Administrator Seema Verma, the CAP reinforced the critical role these tests provide in current pandemic triage protocols to rule out COVID-19. In the letter, the groups outline how these tests "help guide immediate appropriate treatment and minimize disease transmission during this public health emergency. Unfortunately, laboratories are currently absorbing the cost of performing these tests, which are critical to preventing transmission and speeding recovery during this national emergency," the groups stated in the letter.

Nationwide, laboratories are dealing with an exponential increase for RVP tests to identify patients who may be infected with more than one virus at the same time as COVID-19. There are several RVP tests currently; however, coverage of RVPs is severely limited. Current local coverage determinations for respiratory viral panels, which severely restrict coverage only to patients who are immunocompromised are superseded by the clinical circumstances of the public health emergency. Therefore, the CAP and others asked that the CMS cover PCR panel tests to support the critical role that RVPs have in the ongoing public health response to COVID-19.

The FDA on April 24 issued a guidance document covering its Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. The FDA published the guidance to provide a policy to expand the availability of devices for remote reviewing and reporting of scanned digital images of pathology slides, or digital pathology slides, during the COVID-19 pandemic.

On March 26, the CMS issued a memorandum describing its enforcement discretion to ensure pathologists may review pathology slides and images remotely. The CAP had secured the remote work waiver for pathologists following a strong advocacy campaign.

The FDA issued updated guidance on March 26 to accelerate the availability of COVID-19 tests during the national emergency. Laboratories have the option of submitting a laboratory-developed test for an emergency use authorization (EUA) for the serology testing policy under this FDA guidance but it is not required.

Laboratories can bring a serology test online when they include a disclaimer. This FDA Serology testing policy is for laboratories without a EUA. The FDA will not object to the development and distribution by commercial manufacturers of serology tests to identify COVID-19 antibodies. The policy outlines that the test must be validated, and notification must be provided to the FDA.

Here are the details on the FDA policy guidance for serology testing.

The governor of Connecticut rescinded part of a recently issued executive order that would have resulted in a reduction of payment to out-of-network physicians providing emergency services.

On April 21, Gov. Ned Lamont issued a modification to Executive order No. 7U, that originally had stated if emergency services were rendered to an insured by an out-of-network health care provider, the provider could bill the carrier directly. Then the carrier would reimburse the provider the amount the insured’s health care plan would pay if the services were rendered in-network.

In an April 14 letter to the governor, the Connecticut Society of Pathologists and CAP, along with several other physician groups, asked that the provision be rescinded, noting that Connecticut already provides well-established, robust protection for patients who receive out-of-network emergency services. Currently, the statutory payment formula for these services is based on the 80th percentile of charges and emulates the current law in New York and a recently enacted law in Maine.

Executive Order No. 7CC, which addressed protection of public health and safety during the COVID-19 pandemic, specifically and retroactively repeals the sections of Executive Order 7U that would have revised how out-of-network emergency service provides would be reimbursed. Thus, the current statutory payment formula based on the 80th percentile of charges remains in effect.

This is the last week to take the April CAP advocacy news quiz. See how you compare against your fellow CAP members’ in the April News Quiz. Take the April news quiz.