Advocacy Update

Read the Latest Issue of Advocacy Update

• How the CAP Secured Remote Work for Pathologists
• In Historic Stimulus Bill Congress Fixed COVID-19 Coverage Sought by CAP, Lab Groups
• CAP Pushes CMS to Raise Price for COVID-19 Tests
• Federal Waivers Allow Flexibility In Medicare, Medicaid Testing Coverage; States Waive Licensure Restrictions
• CMS Broadens Medicare Accelerated and Advance Pay Program to All Physicians
• Maine Implements Favorable OON Billing Law
• Despite Pathologists’ Veto Request, IN Governor Signs Out-of-Network Bill into Law
• Take a Break: Take Our April Advocacy News Quiz

Through a strategic advocacy campaign deploying the necessary resources only the CAP can provide, the CAP persuaded the federal government to issue a waiver that allows pathologists to work remotely during this national emergency.

On March 26, the Trump administration announced the temporary waiver giving pathologists the regulatory flexibility requested by the CAP. CLIA regulations mandate that pathologists must perform diagnostic tests in CLIA-licensed facilities. But the Centers for Medicare & Medicaid Services (CMS) stated during this public health emergence, it will exercise enforcement discretion to ensure pathologists may review pathology slides remotely using these guidelines.

Backstory of Our Lobbying Effort

The CAP’s campaign began prior to President Donald Trump’s national emergency declaration on March 13. The CAP discussed with the administration additional flexibility for pathologists and laboratory staff but federal officials demurred. The CAP responded after the national emergency declaration with a formal letter to the CMS and Department of Health and Human Services (HHS). Given the relaxation of federal telehealth restrictions on other health professionals, the CAP said it was critical that pathologists be given the discretion to work remotely. In addition, the CAP states that all laboratories should be given the discretion to determine what is best for their staff in managing this pandemic.

On March 16, CAP President Patrick Godbey, MD, FCAP sent an email to all CAP members urging them to contact Congress and the HHS about granting pathologists remote work capability. CAP House of Delegates (HOD) Speaker Kathryn Knight, MD, FCAP, sent a separate message to the HOD to also engage with officials in Washington, DC. Because of your active involvement in grassroots participation, the CAP was able to successfully get the CMS to grant the temporary remote work capability for pathologists.

The CAP also sent a letter to House and Senate leaders about remote work on March 20 while our team of lobbyists spoke directly with officials in the administration and on Capitol Hill.

The CAP’s campaign was bolstered by others joining the effort. We found support from the greater health care community, including the American Hospital Association, American Medical Association, American Clinical Laboratory Association, Association of Pathology Chairs, and American Society of Clinical Pathology joining our cause.

37 Members of Congress Lend Support

As discussions with the administration moved forward, the CAP asked for additional support from Congress to urge the administration to grant pathologists and laboratory personnel the flexibility that the CAP requested. The CAP approached members of Congress with the idea of sending a strongly worded letter to the CMS and worked with the letter’s leaders, Rep. Buddy Carter (R-GA) and Rep. Bobby Rush (D-IL), to gather the signatures in just 48 hours. The CAP again activated its grassroots network to specifically encourage members of the House of Representatives to join Reps. Carter and Rush.

A total of 37 lawmakers signed on and the letter was sent on March 25. One day later, the CMS announced the waiver.

“Pathologists are a critical component in our medical system,” said Rep. Carter after the waiver was granted. “These health care professionals are integral in the testing and diagnosis of patients, and their services are needed now more than ever. As the American health care system continues to face the heavy weight of the coronavirus, it is commonsense to allow pathologists to perform their job no matter where they are.”

The $2 trillion pandemic relief and economic stimulus bill signed into law by President Donald J. Trump on March 28 clarified insurance coverage for all diagnostic tests for COVID-19, suspended scheduled Medicare cuts to clinical laboratory services in 2021, and provided billions of dollars in relief to hospitals and providers preparing for the surge of patients during the current national emergency. The CAP had asked for these provisions with other laboratory groups and is pleased that they are included in the Coronavirus Aid, Relief, and Economic Security (CARES) Act.

Read our summary of the bill.

Given the large expenses to bring online tests to diagnose COVID-19 patients, the CAP stated the recent pricing set for COVID-19 diagnostic tests by the CMS is “woefully inadequate.” The CAP urged CMS to increase the payment to reflect the real costs of the tests accurately and delete the current HCPCS codes U0001 and U0002 and utilize the new CPT code 87635 to price laboratory tests for COVID-19.

In a letter to the agency, the CAP outlined how the initial pricing published March 12 for U00001 and U0002 was too low and lacked the transparency expected in establishing pricing for clinical laboratory fee schedule reimbursement for COVID-19 diagnostic testing.

“Based on our review of costs from our members providing or seeking to offer the test in their laboratory, it is clear that the payment amount set for both tests by the CMS is woefully inadequate,” the CAP stated in the letter to the CMS. “The cost of the reagents, supplies, and labor involved to produce one test kit, as well as the incremental equipment and other fixed capital costs, far exceed the current MAC reported payment amounts. Cost estimates vary greatly between laboratories, and many supplies and clinical labor are now being reported to be in erratic and short supply, resulting in even higher costs for all producers.”

On March 13, the American Medical Association (AMA) fast-tracked CPT code 87635 for COVID-19 laboratory testing. Later on March 26, the AMA announced new CPT guidance for physician practices during the COVID-19 pandemic.

The Food and Drug Administration (FDA) increased flexibility for states to determine whether a laboratory-developed test (LDT) for COVID-19 administered at a high-complexity laboratory is allowed during this national emergency to be used. The FDA Emergency Use Authorization (EUA) has allowed states to authorize such testing upon such findings without prior FDA approval for the duration of the crisis. To date, New York, Maryland, Nevada, and Washington are the only states to have requested the EUA authority to authorize LDTs.

On March 24, HHS Secretary Alex Azar sent letters to all governors further calling on them to prepare for a surge of patients by extending the capacity of the health care workforce. The AMA and the CAP are monitoring and reviewing actions taken by states around the country during this unprecedented crisis to ensure broad expansions for scope of practice of non-physician practitioners do not occur. Instead, physicians and other health care providers must come together as a team focused on diagnosing and curing the sick and vulnerable patient populations.

Most states have issued emergency declarations to allow for interstate physician and health care practice, so that physicians, including pathologists, can provide services in other states for the duration of the emergency.

Other states with laboratory personnel licensure requirements have made emergency adjustments as well. Under the New York emergency declaration (202-5) laboratory technicians not licensed by the state may perform COVID-19 testing provided they "meet federal requirements for high complexity testing." California issued a similar executive order (N-25-20). In Tennessee, (Executive Order 15) individuals without a license employed by a licensed medical laboratory and working under the supervision of a medical laboratory director can perform COVOID-19 testing; provided, that, such an individual must be a postdoctoral fellow in a biological science field such as pathology, microbiology, chemistry, molecular diagnostics, or immunology. Other states like North Dakota have waived out all laboratory personnel requirements.

As COVID-19 ravages the nation, many states were also granted Section 1135 Federal waivers to allow flexibility in Medicare, Medicaid, and CHIP health care coverage for their patients. However, the CAP noted that these waivers do not provide CLIA oversight flexibility as such waivers are limited to the administration of government insurance programs.

The waivers offer states new flexibilities to focus their resources on combatting the outbreak. Thirty-four states so far that received Section 1135 waivers are: Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, Missouri, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Virginia, Washington, and Wyoming.

On March 28, the CMS announced an expansion of its accelerated and advance payment program for Medicare participating physicians and other providers to ensure they have resources needed to combat COVID-19.

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

For more information about the program, read the CMS’s fact sheet on accelerated and advanced payments.

A new Maine law that took effect earlier this month addressed surprise medical bills in a way that is favorable to out-of-network providers, including pathologists. The CAP applauded the new law, noting that it appears to be one of the most favorable legislative outcomes on this issue in the nation.

Under the measure (H.P. 1501 – L.D. 2105), out-of-network health care providers will be paid at the median in-network rate as determined by the state’s all-payer claims database. Previously, out-of-network providers were compelled to accept the average network rate established by health plans.

The new Maine law also expressly states that voluntarily select out-of-network services are not subject to balance billing protections described in the measure. The law, “An Act to Protect Consumers from Surprise Emergency Medical Bills,” took effect on March 18.

The law also includes an arbitration mechanism to address further disputes between providers and health plans when such payments are deemed inadequate by the provider. However, when the disparity between the provider’s charge and the payer-allowed amount is under $750, the carrier must pay the provider at the 80th percentile of billed charges as determined by the payer claims database.

The Indiana Medical Association, the Indiana Association of Pathologists (IAP), and the CAP tried to block legislation that allows Indiana insurance companies to unilaterally determine payment for all out-of-network, non-emergency services at in-network hospitals. Unfortunately, the bill (HB 1004) was signed into law on March 18.

The IAP and the CAP urged the Indiana governor to veto this legislation. In a letter, IAP President Shaoxiong Chen, MD, PhD, FCAP, noted that the bill, which adversely impacts non-emergency hospital-based physicians, including pathologists, was pending during the COVID-19 national public health emergency. Dr. Chen also outlined how the bill is “detrimental to the medical economics of providing critical physician services at the very time the nation and the State of Indiana are relying upon us in the current health crisis.”

The Indiana legislation (HB 1004) is a national outlier when compared to other state laws to regulate out-of-network billing enacted in Texas, Washington, New York, and California. Specifically, unlike these other laws, the Indiana law provides no limitation on how low the payer could decide the "allowed" amount could be for the out-of-network pathology service. Also, unlike other state laws, the new Indiana law provides physicians with no mechanism for appealing the unilateral decision of the insurance payer.

It’s a new month and there is a new CAP advocacy news quiz. In March, over 100 of your CAP members took the March News Quiz. See how you compare against your fellow CAP members’ in the April News Quiz. Take the April news quiz today. 

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