Advocacy Update

Read the Latest Issue of Advocacy Update

• Majority of House Members Support Stopping ‘Devastating’ Medicare Cuts
• Sen. Daines, Rep. Duncan Speak with PathPAC Donors During CAP20
• CAP Demands CMS to Stop Payment Cuts for COVID-19 Tests
• Information Blocking Provisions Go Into Effect November 2
• FDA Issues New Policy for FDA-Cleared Flu and RSV Tests
• Michigan Passes Out-Of-Network Legislation With Pathologist Support
• Test Your Advocacy Knowledge with the News Quiz

A bipartisan group of more than 229 House lawmakers urged Speaker Nancy Pelosi (D-CA) and Minority Leader Kevin McCarthy (R-CA) to stop Medicare cuts to pathologists and other providers in 2021. Support to stop these cuts, which amount a 9% decrease for pathologists next year, reached a critical threshold in the House of Representatives following months of advocacy by the CAP and a coalition group of physician and nonphysician specialists.

The Centers for Medicare & Medicaid Services (CMS) outlined the cuts in the proposed 2021 Medicare Physician Fee Schedule published in August. The CAP and the other provider groups supported the bipartisan letter to House leadership that specifically urged Congress to pass legislation canceling the cuts for 2021 and beyond.

In the October 19 letter, the representatives said the “payment cuts of this magnitude will surely strain a health care system that is already stressed by the COVID-19 pandemic and could jeopardize patient access to medically necessary services.” The group further stated that to protect Medicare beneficiaries “access to care during this pandemic, we as Congress should examine possible bipartisan solutions to address excessively steep cuts. We encourage you to incorporate the resulting policy changes in any upcoming legislation moving through the House.”

The CAP opposes payment cuts to pathologists in 2021 and launched an advocacy campaign to encourage our members to contact their federal legislators. Already, hundreds of CAP members have contacted, called, and virtually met with many Congress members to educate them on the impact these cuts will have on patient access to care and reimbursement. Only Congress can stop the cuts. As such, we are asking CAP members to tell their representatives and senators how destructive these drastic decreases in payment to pathologists will be to their constituents back home.

Go to the CAP’s action center to send a message to your representatives in Washington, DC.

To learn more, watch an on-demand training webinar explaining everything you need to know about this issue and how you can best engage.

Make sure you follow the CAP Advocacy Twitter account to get breaking legislative and regulatory news. If you’re on social media, please feel free to help us get the word out by using the hashtag #fightthecuts!

PathPAC held its annual reception virtually on October 14 by hosting Sen. Steve Daines (R-MT) and Rep. Jeff Duncan (R-SC), more than 40 members of the CAP’s political action committee.

Members of the CAP and PathPAC spoke with the two federal lawmakers for about 30 minutes. Sen. Daines and Rep. Duncan answered questions from pathologists after delivering brief opening remarks, which included an update on the current status of a COVID-19 relief package. CAP members then asked them questions and for their support on key issues concerning pathologists. Top issues discussed included Medicare cuts to pathologists that are set to take effect in 2021, private insurance coverage of COVID-19 tests, legislation to stop surprise medical bills, and funding to support autopsy services.

Sen. Daines has been extremely helpful to Montana pathologists during the COVID-19 and he is also been a leader in the Senate advocating for Congress to mitigate the upcoming Medicare cuts to pathologists.

PathPAC is bipartisan and represents the interests of pathologists on Capitol Hill through political and financial means. PathPAC strives to increase the political awareness of our members through political analysis, education, and helping our members build relationships with members of Congress. PathPAC is the voice of pathology in the election process. Through the PAC, the CAP provides direct support for federal candidates for Congress. The PAC also has a political education fund that supports the political education of our members through events like the annual Policy Meeting in Washington, DC.

Learn more about PathPAC and how you can contribute

The CAP strongly objected to Medicare cuts to fees for certain COVID-19 tests, which the CMS announced October 15. Additionally, the CAP asked the CMS to cease implementation of this payment structure that will cut fees for COVID-19 testing performed on a high throughput technology platform and penalize laboratories in the middle of a global pandemic.

CAP President Patrick Godbey, MD, FCAP released a statement regarding this recent decision saying that “every pathologist and the laboratory that he or she leads strives to provide patients with high-quality testing and fast results—especially during this pandemic,” Dr. Godbey said. “With roughly one million COVID-19 tests being provided every day, laboratories are processing tests efficiently and quickly in most instances. However, there are several factors outside of our control that lead to delays. These factors include the delivery times of off-site specimen collection and the availability of testing supplies needed to run tests. The CMS’ new pricing scheme does absolutely nothing to solve these problems but will penalize laboratories and create a new administrative burden during the billing process.”

On October 15, the CMS said it would cut the price for high-throughput COVID-19 tests by 25%, reducing the fee to $75 from $100, beginning January 1, 2021. Medicare will also adopt an add-on payment of $25 for tests run on the high-throughput platform if the laboratory completes the test in two calendar days or less, and if the majority of its testing using the high-throughput technologies is done in two calendar days or less for all patients (not just Medicare beneficiaries) in the previous month. This cut will take effect despite the fact that current fees are already inadequate in many parts of the country.

For non-high throughput COVID-19 laboratory tests, local Medicare Administrative Contractors remain responsible for developing the payment amount in their respective jurisdictions. Medicare contractors are currently paying approximately $51 for those tests. The CMS earlier defined a high-throughput technology as a platform that employs automated processing of more than two hundred specimens a day. Examples of high-throughput systems include technologies the Roche cobas 6800 System, Roche cobas 8800 System, Abbott m2000 System, Hologic Panther Fusion System, GeneXpert Infinity System, and NeuMoDx 288 Molecular.

In a October 16 letter to the CMS, the CAP “called on the administration to cease implementation of a payment structure that will cut fees for COVID-19 testing performed on a high throughput technology platform and penalize laboratories in the middle of a global pandemic.”

Earlier this year, the CMS and the Office of the National Coordinator for Health Information Technology (ONC) finalized information blocking and interoperability regulations to change how providers, including pathologists, exchange health data. The final regulation information blocking provision starts on November 2 and applies to Certified Electronic Health Record Technology (CEHRT) but not laboratory information systems (LISs). However, pathologists and laboratories are required to provide certain information to their organization’s CEHRT. As a partner to ease reporting and regulatory burdens for pathologists, the CAP wants to note that there are complex situations in which ONC will consider certain exceptions to information blocking that would warrant blocking the release of information.

While it is the performing laboratory’s responsibility to report results to the ordering provider (or laboratory in the case of send-outs), the specifics of what information should be provided are not indicated in the final regulation. Therefore, it will be a local decision between the pathologist and their organization. While important data stewardship issues may exist with patient portals and modules like “CareEverywhere” in Epic, there are not direct regulatory or accreditation issues for the performing laboratory.

In most cases, patient care health data will be reported to the certified Electronic Health Record (EHR) and then on to the patient through a portal like MyChart. The provider organization decides what to report by that mechanism in consultation with its medical staff. A similar situation would exist where a laboratory does outreach work and reports back to the office EHR. That report should satisfy information-sharing requirements, and the responsibility for reporting directly to patients should rest with the EHR. In cases where laboratories support direct patient testing without a report to an EHR or physician, there would be a need to maintain a mechanism for reporting to the patient or others a patient might designate—but that need exists apart from the 21st Century Cures Act final regulation.

In most instances, the laboratory would not require reporting other than the required regulation that has agreed to have been provided to its clients. Reporting to the ordering physician with reasonable turnaround time should satisfy the law.

The Food and Drug Administration (FDA) implemented a new policy on October 13 for FDA-cleared flu and Respiratory Syncytial Virus (RSV) tests citing the national health crisis and the upcoming flu season. The new Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency became effective policy without the traditional public comment period from industry stakeholders, like the CAP.

The new guidance is being implemented without prior public comment because the FDA “determined that prior public participation for this guidance is not feasible or appropriate.” However, the guidance document remains subject to comments from the public following the agency’s good guidance practices.

Many flu virus and RSV tests require the same critical components as many COVID-19 molecular assays. The new FDA policy expanded access to certain FDA-cleared molecular tests intended to detect and identify flu viruses, including molecular influenza tests that also detect and identify RSV.

Read the full guidance

The Michigan Society of Pathologists (MSP) and the CAP worked together to support out-of-network billing legislation, (HB 4459) and (HB 4460), which passed the Michigan Legislature on October 13. The legislation protects patients from balance billing while providing an out-of-network payment methodology that is the greater of 150% of Medicare, or the median in-network rate. Both the MSP and the CAP worked with the Michigan State Medical Society's physician coalition to advocate for critical changes to the bill. Michigan Governor Gretchen Whitmer is expected to sign both bills into law soon.

Both the MSP and the CAP were engaged through the entire course of the legislative process. In the final stages of the process, health plans urged the state legislature to allow them to divert payment for out-of-network services to the patient who would then have to be billed by providers. Because of grassroots support of Michigan pathologists and testimony from the MSP, the group countered that such a payment diversion would compel providers to collect additional payments from enrollees beyond co-insurance, deductibles, and co-payments. The provision was ultimately removed by a Senate amendment that requires health plans to directly pay out-of-network providers, as is the case with other state out-of-network laws.

Early in the process, the MSP and CAP successfully urged that the Medicare minimum out-of-network payment safeguard be raised from 125% of Medicare to 150% of Medicare. Both groups also asked to remove the initial legislation's obligation on pathologists and other physicians to provide a written estimate of services before the service's performance. The final bill clarified that the written estimate is only applicable when the service is scheduled in advance or involves direct patient interaction.

While the final bill does not contain an arbitration mechanism for non-emergency services or health plan network adequacy advocated by pathology, both the MSP and the CAP are pleased with both bills' outcome. However, both groups still see the need and opportunity for additional legislative work on outstanding issues next year.

Think you have the Advocacy knowledge after reading this week’s issue? Test it with the Advocacy news quiz. See how you compare against your fellow CAP members’ by taking this month’s quiz and share it on social media.

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