Advocacy Update

Read the Latest Issue of Advocacy Update

• CAP Details Priorities for Next COVID-19 Relief Legislation
• Congress Can Act to Address Testing Supply Chain Issues, CAP Says
• Medicare Finalizes Proposal for Pathology Services in 2021, CAP Advocating to Stop the Cuts
• CMS Proposes 2021 Medicare Quality Payment Program Requirements
• CAP Seeks Greater Clarity on Data Reporting Requirements from CDC
• FDA Revokes Umbrella EUA, Publishes Additional COVID-19 Updates
• Michigan Pathologists, CAP Call for Amendments to State Surprise Bill Legislation
• Attention: Proposed 2021 Medicare Payment for Pathologists Webinar Postponed
• New Month, New Advocacy News Quiz

With the United States still grappling with the coronavirus pandemic, the CAP urged Congress to take up COVID-19 emergency response legislation and enact the priorities important to pathologists and their patients. These priorities include support for pathology practices and laboratories, allocating additional resources to perform SARS-CoV-2 testing, liability protections, resolving supply and equipment shortages, and offering funds to support medical examiners.

Congressional leaders are presently negotiating COVID-19 relief legislation. Earlier in July, the House and Senate proposed competing for COVID-19 bills that failed to gain traction. The CAP supports several provisions in both bills and has sought to build consensus amongst lawmakers in Washington, DC. In an August 3 letter to Congress, the CAP urged top leaders in the House and Senate to consider its recommendations to support pathologists and frontline providers in any comprehensive strategy.

Support for Pathology Practices

The CAP called on congressional leaders to allocate additional funds providing financial relief to pathologists. Many small businesses, including pathology practices and laboratories, are under tremendous stress due to lost revenue from the pandemic. To relieve these financial pressures, the CAP urged Congress to allocate more money and support for the Provider Relief Fund, Medicare Accelerated and Advance Payment Program, and the Paycheck Protection Program.

The CAP also said people must have access to timely and accurate testing to reopen schools, businesses, and other parts of the economy. Congress must provide a significant financial commitment to testing. Currently, the reimbursement structure for performing SARS-CoV-2 testing is inadequate. The cost of the typical laboratory performing these tests should be taken into account when prices are determined. In addition, the CAP supports additional funding for contact tracing so state and local governments can fund COVID-19 testing and surveillance activities.

Liability Protections for Physicians

The CAP also urged Congress to enact targeted liability protections where health care services are provided or withheld in situations beyond the control of physicians. Examples of these situations include government guidelines, directives, and lack of resources due to COVID-19. The CAP said protections should also extend to those who provide care in good faith during the COVID-19 public health emergency. These liability protections would not extend to situations of gross negligence or willful misconduct.

Following up on the CAP’s July 30 meeting with White House officials to discuss testing supply shortages, the CAP urged Congress to take up legislation to increase testing supply and equipment inventories.

In recent months, laboratories have reported excess overall testing and instrument capacity but are constrained by a variety of limitations. Laboratory directors cite persistent problems acquiring testing supplies as the greatest barriers to increased testing. In response, the CAP has engaged with federal officials to help its members overcome ongoing obstacles they face in performing diagnostic and serology tests.

In its August 3 letter to congressional leaders, the CAP highlighted Senate and House provisions, such as supporting manufacturing surge capacity and strengthening the Strategic National Stockpile, to assist with the current and future pandemics.

Offer Assistance for Medical Examiners

The CAP also encouraged Congress to extend federal funds addressing the fiscal impacts of the pandemic affecting state, local, and tribal governments. Specifically, there should be a direct commitment of funds to assist local medical examiners who are dealing with an increased volume of work and have a key role in understanding the impact of COVID-19.

Congress must also provide additional funds to the Centers for Disease Control and Prevention (CDC). This funding would further assist federal, state, and local public health agencies coordinate efforts to respond to the pandemic.

The Centers for Medicare & Medicaid Services (CMS) will follow through with significant payment cuts to pathologists in 2021, the agency announced in its proposed 2021 Medicare Physician Fee Schedule on August 3. The reduction, which the CAP has strongly opposed for more than a year, is a result of budget neutrality requirements that offset the cost of major changes to evaluation and management (E/M) services set to take effect next year. Without intervention, pathologists will see an overall decrease in Medicare payment of 9% to fund increases in payment for E/M services.  

The CAP has advocated stopping these cuts through direct lobbying with the CMS, Congress, and other key stakeholders. These cuts could not come at a worse time for pathologists and their laboratories, due to the effects of the current COVID-19 pandemic. At present, the CAP is leading a major summer advocacy campaign to urge Congress to stop these cuts. The CAP will also continue communicating its objections directly to the CMS (comments on the proposed fee schedule are due by October 5).

Although the CMS accepted the CAP’s recommendations on other changes, such as those for molecular interpretation services elsewhere in the fee schedule, the cuts due to the E/M policy change will have a detrimental effect on pathologists' reimbursement in future years. The exact impact of the overall 9% decrease in 2021 on an individual pathologist's reimbursement will depend on the physician’s case mix.

The proposed 2021 conversion factor used for the fee schedule’s payment formula is $32.26, representing a 10.61% decrease from the 2020 conversation factor. Review all the proposed changes to pathology services in our proposed 2021 Medicare Physician Fee Schedule Impact Table.

Proposed 2021 Medicare Physician Fee Schedule

Through its ongoing work to protect the value of pathology services, the CAP recommends physician work relative value units (RVUs) used to calculate the professional component. Because the CAP engaged with the CMS for the past year, the CAP developed direct practice expense inputs for pathology services, impacting payment for the technical component. The CAP recommended, and the AMA RUC agreed to increase the current physician work RVU from 0.37 to 0.93 for the molecular interpretation code G0452. The CMS agreed and proposed to increase the physician work RVUs for G0452.

Increase in Evaluation and Management (E/M) Services Causes Reimbursement Decrease by 9 % to Pathology in 2021

The CMS outlined that payment to pathologists will decrease by 9% overall due to the E/M changes and to the CMS’ budget neutrality payment policies and E/M utilization rate by pathologists. Pathologists were not the only physician specialty to see such sharp cuts. Other specialties, such as radiology, that do not generally bill office/outpatient E/M codes will see the greatest decrease in payment in 2021 of up to 11%.

The CAP, together with a coalition of 45 other medical specialties, has worked with the CMS and Congress to describe the detrimental impact these cuts would have on health care during the COVID-19 national emergency. The CAP has also urged congressional leaders to fix the E/M issue in future COVID-19 legislative bills.

What Will Be the Impact of the Proposed Fee Schedule on Your Practice?

CAP members can learn more about the proposed fee schedule changes by attending a complimentary webinar on August 14 at 2 PM ET where experts will review the proposed 2021 Medicare regulations and their impact on payment for pathology services.

Register today

On August 3, the CMS published its proposed 2021 Quality Payment Program (QPP) proposals that will take effect next year. According to the proposed regulation, nearly all pathologists will be required to participate in Medicare’s QPP either through Advanced Alternative Payment Models (APMs) or the Merit-based Incentive Payment System (MIPS).

With the COVID-19 pandemic's impact, the CAP has advocated reducing MIPS reporting burdens for pathologists. The CMS previously announced COVID-19 related relief for MIPS participants who would not be able to submit MIPS data in the current performance year (2020). These practices can submit an extreme and uncontrollable hardship exemption application that CMS will review on a case by case basis.

In this regulation, the CMS proposed additional COVID-19 reporting relief, including:

• Slightly decreasing the planned increase of the performance threshold to avoid a penalty;
• Delaying implementation of MIPS Value Pathways (MVPs) until 2022; and
• Avoiding skewed benchmarks due to an impact in data submission by using for benchmarks only 2021 performance year submitted data.

Proposed 2021 MIPS Reporting for Pathologists

In 2021, pathologists reporting MIPS will have to take action to avoid penalties that reduce future Medicare Part B payments for their services. Performance in MIPS in 2021 affects Medicare Part B payments in 2023, by +/-9%.

In the proposal, the CMS said it will:

• Increase the Performance Threshold to 50 points from the current 45 points. The Exceptional Performance Threshold is proposed to remain at 85 points.
• Maintain the Pathology Specialty Measure Set as-is for 2021. The Pathology Specialty Measure Set will contain the same six quality measures that it did in 2020.

The CAP has actively worked with the CMS to demonstrate the need for more appropriate and alternate measures and improvement activities so that pathologists can more fully participate in MIPS.

Alternative Payment Models

For those pathologists who practice in an Alternative Payment Model (APM), the proposed 2021 QPP regulation provides a new APM Performance Pathway (APP) composed of a fixed set of measures for each performance category. The new APP participation pathway is only for MIPS APM participants and will start in 2021. The agency is also making changes to the calculation for the QP Threshold Scores used in making Qualifying APM Participant (QP) determinations. Finally, the CMS is also making changes to the reporting for Accountable Care Organizations (ACOs) participating in the Shared Savings Program.

The CAP will analyze in detail the provisions of the proposed regulation and submit comments during the agency’s 60-day comment period.

What Do The 2021 Proposed QPP Regulations Mean For Your Practice

The CAP will review detail the provisions included in the proposed regulation during a member-exclusive webinar on August 14 at 2 PM ET.

Register today

On July 30, the CAP sought additional guidance from the Centers for Disease Control and Prevention (CDC) regarding additional data for COVID-19 tests that laboratories must report to the federal government. The CAP is engaged with the agency to ensure new rules are not overly burdensome to laboratories while ensuring that the government receives the information it needs for necessary public health surveillance activities during the pandemic.

Beginning August 1, laboratories were expected to follow the data reporting guidance published by the Department of Health and Human Services (HHS) in June. The CAP has engaged with the HHS and CDC multiple times regarding barriers laboratories face to meeting the requirements. To reduce the reporting burdens on clinical laboratories, the CAP wants the HHS to extend the implementation deadline of this regulatory guidance until further clarification is provided. The CAP suggested delaying the reporting requirements until laboratories can effectively address the abilities to provide this data consistently during this national emergency. However, the HHS and CDC provided no such delay.

In its July 30 correspondence with the CDC, the CAP sent a dozen questions to the government that, once answered, will provide laboratories with additional information on, for example, who has oversight responsibility and data reporting alternatives. The CAP will publish these answers once it receives them from the CDC.

The Food and Drug Administration (FDA) issued Emergency Use Authorizations for SARS-CoV-2 diagnostic tests that include the pooling of specimens, and the first EUA for the screening of asymptomatic individuals. Review the FDA’s list of In Vitro Diagnostics EUAs.

In addition, the FDA issued guidance on transport media, revoked the serology umbrella EUA, and updated its frequently asked questions to include information about SARS-CoV-2 diagnostic tests and sample pooling:

• The FDA issued COVID-19 Transport Media Policy guidance to expand the availability of transport media used for testing certain clinical specimens during the COVID-19 public health emergency. The agency also published new FAQs on Viral Transport Media During COVID-19 and updated its Testing Supply FAQs.
• The FDA revoked the Umbrella EUA for Independently Validated Serology Tests for SARS-CoV-2. Any test that was once eligible for consideration under the umbrella EUA will now be considered for an individual EUA.
• The FDA updated the FAQs on Testing for SARS-CoV-2 webpage to include a list of commercial manufacturers of diagnostic tests that have been removed from the notification list. The FDA now has “do not use” lists for laboratory developers of diagnostic tests, commercial manufacturers of diagnostic tests, and commercial manufacturers of serological tests.

The Michigan Society of Pathologists (MSP) and the CAP called for changes to state legislation that fails to adequately protect patients from surprise medical bills and that passed the Michigan House last month. On July 29, James Richard, DO, FCAP, provided testimony on behalf of MSP to the state Senate Insurance Committee, requesting amendment to legislation that ensures patients are not dragged into billing disputes by their own insurance companies who do not want the financial responsibility to pay out-of-network physicians.

Michigan insurers had amended the out-of-network legislation before it passed the House so that patients would receive payment from the health plan and then be held accountable for paying the out-of-network bill.

“If enacted this payment diversion will force physicians to then bill patients for the health plan out-of-network payment amounts to which the providers are legally entitled,” Dr. Richard said. “This provision does not take patients out of billing disputes—it drags patients into the billing dispute and thereby defeats the primary purpose of this legislation.”

The legislation, Michigan House Bill 4459 has drawn strong opposition from, the CAP, and several others, unless it amended to take patients out of the billing dispute. Both the CAP and the MSP support the current 150% Medicare safeguard in the out-of-network payment and language on network adequacy, but are also supporting several amendments to the bill to enhance the arbitration provision in the current bill. Specifically, amendments from physicians would:

• Require insurers to directly pay physicians and limit patients’ out-of-pocket expenses.
• Set median in-network payment rate to 115% using the 2017 rate schedule adjusted for inflation.
• Allow payments from the same insurer for a similar service to be bundled together when accessing arbitration to ensure a more efficient process.
• Ensure criteria for arbitrators to consider when determining the appropriate payment for a disputed claim includes consideration of any prior contracting between the provider and the insurer.

Due to a delay in the CMS’ release of the proposed 2021 Medicare Physician Fee Schedule and Quality Payment Program regulations, the CAP has postponed its webinar to Friday, August 14, at 2 PM ET/ 1 PM CT.

Webinar presenters will be the Chair of the Council on Government and Professional Affairs Jonathan Myles, MD, FCAP; Chair of the Economic Affairs Committee W. Stephen Black-Schaffer MD, FCAP; and Vice Chair, Economic Affairs Committee Diana Cardona, MD, FCAP.

During the 60-minute webinar, attendees will learn about updates to the 2021 Medicare Physician Fee Schedule and the Quality Payment Program regulations and its impact on pathologists. The CAP panel will also answer questions from attendees.

If you are unable to attend the live event, a link to view an archived recording of the presentation will be sent to all registrants following the webinar. The recording can be viewed at your convenience.

We appreciate your flexibility and look forward to your participation during the webinar on August 14.

Register today for the webinar 

It’s a new month and that means a new Advocacy News Quiz. Last month over 100 CAP members took the July news quiz. See how you compare against your fellow CAP members’ in this month.

Take the August news quiz