Advocacy Update

Read the Latest Issue of Advocacy Update

November 3, 2020

In this Issue:

UnitedHealthcare Delays Test Registry in Response to Concerns from CAP

After discussions with the CAP over concerns of overburdening laboratories during the current pandemic, UnitedHealthcare announced it will delay implementation of its test registry program until April 2021. On October 30, UnitedHealthcare said it pushed back the deadline of its laboratory test registry to ensure compliance with new requirements.

CAP leaders previously met with UnitedHealthcare to express continued opposition of the insurer’s laboratory test registry. The CAP leaders had said that the new requirements would interfere with critical diagnostic care to patients and create unnecessary reporting burdens. The CAP urged UnitedHealthcare to cease implementing the program and work with the CAP to address any outstanding needs for information and transparency.

The CAP has also expressed concerns about laboratory responsibility for specifying the maximum service units and providing price transparency because the clinical request for diagnostic services is not under the pathologist's control. Additionally, the complexity of insurance plans makes determining the patient's liability for payment for such services complicated to assess in advance. Finally, the CAP has stressed the difficulty of implementing this program during the COVID-19 public health emergency. UnitedHealthcare acknowledged this unique situation and said they would make adjustments as needed.

Not only did CAP leaders recently meet with UnitedHealthcare, but we also sent a letter outlining the issues with the test registry. Under the UnitedHealthcare program, all freestanding and outpatient hospital laboratories will need to register.

The CAP remains engaged with UnitedHealthcare regarding its registry and will provide additional updates to CAP members as they become available. Learn more about the CAP’s private sector advocacy.

CAP Praises Bipartisan House Bill to Delay Steep Medicare Cuts to Pathologists

In a statement released October 30, the CAP applauded Reps. Ami Bera, MD, and Larry Bucshon, MD, for their leadership on the introduction Holding Providers Harmless From Medicare Cuts During COVID-19 Act of 2020, which would delay Medicare cuts to pathology practice until 2023.

CAP President Patrick Godbey. MD, FCAP said the bill would “stop Medicare cuts set to hit our pathology practices serving patients across the country beginning January 1, 2021. The Holding Providers Harmless From Medicare Cuts During COVID-19 Act of 2020 will address this issue by giving providers a hold harmless payment for the next two years. The CAP appreciates that this bill will prevent sharp decreases to pathologists and support the very diagnostic services that drive health care decisions to keep patients healthy.”

In addition to the lead sponsors, the CAP commended the efforts of the bill’s original sponsors: Reps. Brendan Boyle, George Holding, Raul Ruiz, MD, Phil Roe, MD, Abby Finkenauer, and Roger Marshall, MD.

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.

Fight the Medicare Cuts

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.

Increased State, Federal Coordination Among Lessons Learned Regarding COVID-19 Laboratory Regulations

The CAP informed the Clinical Laboratory Improvements Advisory Committee (CLIAC) on October 28 and 29 of key lessons learned from COVID-19 pandemic, including the burden of additional laboratory reporting and the lack of state and federal coordination of Laboratory Data Exchange. The CAP conveyed the three main lessons learned from the initial COVID-19 response which were: uniform consistent action, regulatory waivers, and coordination of federalist system. The CAP shared additional lessons from pathologists, including the impact on pathologists and the laboratories they lead.

One top issue of the many lessons learned was the rollout of the mandatory laboratory reporting requirements for COVID-19 data. The CAP opposed some aspects of laboratory COVID-19 reporting, and remains concerned about this unfunded mandate, and would like increased coordination between state and federal agencies regarding laboratory supplies and COVID-19 testing coordination.

In an October 27 statement prepared for CLIAC, the CAP outlined lessons learned during the COVID-19 pandemic. For instance, the CAP supported the need for “improved public health reporting regarding SARS-CoV-2/COVID-19, the CAP believes that the new rules and penalties place unworkable requirements and undue burden on laboratories during a time in which laboratories’ resources must focus on performing vital SARS-CoV-2/COVID-19 testing.” The HHS will only penalize laboratories for failing to report positive or negative test results, and laboratories would further receive a three-week grace period to meet new rules.

One of the lessons the CAP stated is how “clinical laboratories worked quickly to ramp up diagnostic testing. To do this successfully, consistent regulatory guidance was needed to support these efforts. While the FDA and the CMS have made recent improvements in this area, initial delays and shortcomings continue to affect the prevalence of testing in the United States.”

Another lesson was the need for a coordinated response between federal and state governments. The CAP reiterated that, “there has been a lack of clarity on coordination between states and federal government on regulatory guidance, supplies and information. The Administration released a testing plan calling for states to lead many of the testing activities which led states, hospitals, and clinical laboratories to compete for testing supplies. Many laboratories report excess testing capacity and excess instrument capacity but are being constrained by different factors.”

Additionally, Jonathan Myles, MD, FCAP, chair of the CAP Council on Government and Professional Affairs, provided testimony on the impact of COVID-19 on pathologists and laboratories. In his statement, Dr. Myles discussed, “the pressures faced by pathologists and the rest of the laboratory workforce are increasing. As a result of the public health crisis, many are seeing an increase in staff burnout. Further, laboratories are imposing hiring freezes, reducing benefits, furloughing employees, and cutting pay.” These concerns are reflected in the CAP’s latest survey, where 85% of board-certified pathologists nationwide reported the COVID-19 pandemic has negatively affected pathologists. Dr. Myles further outlined how, “coordination between the federal and state governments is required with clearly defined roles and responsibilities for the federal and state government. Included in these roles and responsibilities should be who has primary responsibility for interfacing with clinical laboratories on infrastructure and resources such as supplies.”

The CAP continues to engage with the CLIAC and other federal agencies during this unprecedented time.

Provider Relief Fund Deadline is November 6

The deadline to apply for Provider Relief Fund payments from the Department of Health and Human Services (HHS) is November 6.

On October 1, the HHS announced it would allow up to $20 billion in new funding for providers on the frontlines of the coronavirus pandemic. The HHS will update its most recent Provider Relief Fund reporting instructions to broaden the use of program. The CAP had urged Congress and the HHS to give pathologists and laboratories greater support through relief funds to pathologists. We have also encouraged pathologists to apply for these federal programs when eligible and have provided CAP members with resources for the program.

Further, the HHS invited laboratories that already received relief fund payments to apply for additional funding “that considers changes in patient care operating revenue and expenses caused by the coronavirus.” The HHS also expanded the list of eligible applicants to providers who had not previously received fund payments. The newly eligible providers will receive “a baseline payment of approximately 2% of annual revenue from patient care plus an add-on payment that considers changes in operating revenues and expenses from patient care, including expenses incurred related to coronavirus.” All payment recipients must accept the associated terms and conditions.

Reporting Requirements Update

The HHS amended the reporting instructions to include revenues attributable to coronavirus. After reimbursing health care-related expenses attributable to coronavirus, providers may use remaining funds to cover any lost revenue from patient care related sources.

The HHS has published several resources, and the CAP is here to help. A policy memorandum on the reporting requirement decision can be found here. The amended reporting requirements guidance can be found here. Provide us with your feedback and additional questions about these financial programs by emailing the CAP at smallbusiness@cap.org.

HHS Pushes Back Deadline for Information Blocking Rules to April 2021

Citing public health threats posed by the coronavirus pandemic, the HHS delayed enforcement of new information blocking and interoperability rules that change how providers, including pathologists, exchange health data. The delay was announced on October 29, just days before the rules were set to go into effect on November 2. The CAP had been keeping its members informed of the upcoming deadline and our advocacy efforts on this issue, and first announced the delay on our Twitter account.

Earlier this year, the CMS and the Office of the National Coordinator for Health Information Technology (ONC) finalized the information blocking and interoperability regulations that aim to improve the exchange of health data and information and give patients ready access to their health care information. The rules specifically apply to Certified Electronic Health Record Technology (CEHRT) and not laboratory information systems (LISs). However, pathologists and laboratories are required to provide certain information to their organization’s CEHRT, such as a hospital or health system electronic health record system. As a partner to ease reporting and regulatory burdens for pathologists, the CAP has noted there are complex situations in which ONC will consider certain exceptions to information blocking that would warrant blocking the release of information. The American Medical Association has created documents, Part I and Part II, with more information about these new regulations.

The new deadline to comply with the rules, which are required by the 21st Century Cures Act, is now April 5, 2021, giving pathologists and laboratories more time to become familiar with requirements. Most decisions on what information to share will be determined by the pathologist, laboratory, 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.

Pathologists Must Update Billing Info By November 13 to Get APM Payments

The CMS notified pathologists and other qualifying Alternative Payment Model (APM) participants that they may need to verify their Medicare billing information by November 13 in order to receive their 5% APM incentive payment.

Many eligible pathologists who were Qualifying APM Participants based on their 2018 performance began receiving their 2020 5% Incentive Payments last month. If you have already received your payment, you do not need to do anything. However, pathologists who have not received a payment check out this public notice and verify your Medicare billing information. The CMS will not issue APM Incentive Payments if pathologists do not verify their Medicare billing information.

For more information, review the Public Notice File for Payment Year 2020 Excel Spreadsheet and supporting forms in the 2020 Qualifying Participant Notice for APM Incentive Payment zip file. The spreadsheet will indicate which form you need to submit—the IP Form and/or 588 Form—in order to verify your Medicare billing information.

If you have any questions or require assistance, please contact the Quality Payment Program Service Center via telephone at 1-866-288-8292 or via email at QPP@cms.hhs.gov.

CMS Releases Preliminary 2019 Quality Payment Program Results

Eligible pathologists who submitted 2019 Merit-based Incentive Payment System (MIPS) data can view their performance feedback and MIPS final score. The CMS released a blog post and infographic to share preliminary participation data for the Quality Payment Program (QPP) in 2019. The CAP encourages all MIPS eligible pathologists to log in and review their MIPS 2019 scores.

For 2019 MIPS, the CMS automatically applied the extreme and uncontrollable circumstances policy to provide relief to clinicians due to the COVID-19 pandemic. Since budget neutrality still applies, 2019 payment adjustments were lower than in 2018. Those clinicians and groups who scored above the performance threshold (30 points) but below the exceptional performance threshold (75 points) received a 0.00% payment adjustment instead of a positive payment adjustment. Those clinicians and groups who scored above the exceptional performance threshold of 75 points received a positive payment adjustment ranging from 0.09% - 1.79%.

Individual pathologists can access their 2019 MIPS scores by logging in to the QPP web site with their QPP login credentials. If you have any questions or require assistance, you can contact a CAP MIPS staff member at mips@cap.org or the Quality Payment Program Service Center via telephone at 1-866-288-8292 or via email at QPP@cms.hhs.gov.

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