Advocacy Update

April 20, 2021

In this Issue:

CAP Leaders Testify on Laboratory Regulations for Post Pandemic Practice

As the leading accreditor of laboratories, CAP leaders participated in the April 14 Clinical Laboratory Improvement Advisory Committee (CLIAC) meeting on laboratory regulations during and after the COVID-19 pandemic. Joe Saad, MD, FCAP, who is the Vice-Chair of the Council of Government and Professional Affairs (CGPA), and Christina Wojewoda, MD, FCAP, who is the Chair of the Microbiology Committee, testified before the committee on issues related to laboratory-developed tests (LDTs) and consumer at home tests during the COVID-19 pandemic. The CAP works to ensure regulations protect patients without overburdening pathologists and laboratories, including advocating for a sensible public-private oversight approach and guaranteeing the quality of laboratory-developed tests.

During the meeting, Dr. Saad provided testimony on the quick deployment of the emergency use of laboratory-developed tests (LDTs) during the COVID-19 pandemic. Dr. Saad stated in his submitted testimony that, “The (EUA) process of having uniform standards and guidelines made the ramp-up process more effective, but timely consistent communication from federal agencies is essential. While the Food and Drug Administration (FDA) and the CMS have made recent improvements in this area, initial delays and shortcomings affected the prevalence of testing in the United States.” In light of Dr. Saad’s testimony and discussion, the group recommended creating regionals certified hubs exempt from the Emergency Use Authorization (EUA) process, developing a response network of academic and community laboratories for LDTs.

Dr. Saad also testified on laboratory regulations should include flexibility granted during the public health emergency. “We welcomed the CMS providing flexibility on-site locations, the (remote sign-out) waiver was granted on March 26, 2020 – two weeks after the national emergency declaration – delaying critical testing. Importantly, while we support efforts to streamline administrative procedures for personnel, the CAP strongly believes the current CLIA personnel requirements for testing should be maintained.” The CLIAC committee did discuss on the need for CLIA modernization, which would expand the clinical laboratory response network to pandemics and remote work waivers under CLIA.

Additionally, Dr. Wojewoda provided testimony on Point-of-Care Testing, Self-Collection, and Self-Testing. Because of COVID-19, over-the-counter diagnostic testing increased, the FDA is moving to enable an increased level of at-home diagnostic testing. Dr. Wojewoda, explained the critical performance of these tests are inferior to traditional laboratory testing with the end-user further diminishing the performance of these systems. The CLIAC discussed ways to improve access to US populations, educate end-users on implications of results and limitations of the systems, and determine whether additional regulations are needed.

CAP Calls on UnitedHealthcare to Withdraw Designated Provider Program

The CAP continues to express concerns with UnitedHealthcare on their Designated Diagnostic Provider laboratory program. In an April 20 letter, the CAP urged UnitedHealthcare to immediately and permanently cease implementation of this program because of the burden and confusion created for pathologists and their patients, the lack of transparency, and – most importantly – the potential financial harm for UnitedHealthcare plan members. The CAP works with the private-sector insurers, like UnitedHealthcare, to ensure access to pathology and laboratory services across all settings.

The Designated Diagnostic Provider program requires laboratories to meet UnitedHealthcare-determined efficiency and quality requirements to become a Designated Diagnostic Provider. However, laboratories that do not meet these requirements will still be in-network, “but UnitedHealthcare will not cover and will deny payment for outpatient diagnostic laboratory services provided by these facilities, leaving patients likely ‘liable for charges.’” The CAP told UnitedHealthcare that it would potentially subject patients to the full payment for services received at in-network but non-DDP facilities and is counter to efforts to protect patients and eliminate surprise medical bills.

“Even those patients who are diligent about seeking care from in-network facilities may find themselves with unanticipated bills,” the CAP letter states. “Similar confusion can be expected from ordering providers when making referrals. This is the essence of our concern: the proposed program sets up a needlessly confusing situation by having providers who are nominally in your network (as explained to us) whose services will not be covered, which will (legitimately) be perceived as predisposing to the issuance of ‘surprise bills’ to patients.”

The CAP also reiterated concern with the additional requirements put forward by UnitedHealthcare in their Laboratory Test Registry Protocol, saying it would take significant time, resources, and education to implement, on top of the efficient and adequate CPT coding currently in use. The CAP strongly supports the continued use of the CPT code set as it is developed with broad stakeholder input and provides a uniform language that accurately describes medical, surgical, and diagnostic services provided by physicians and other qualified health care professionals.

UnitedHealthcare had announced the new Designated Diagnostic Provider program impacting outpatient laboratory services for fully insured commercial members. Effective July 1, 2021, the insurer will only cover outpatient laboratory services for members when delivered by a “Designated Diagnostic Provider” laboratory. Laboratories that are not a “Designated Diagnostic Provider” will remain in-network, but outpatient diagnostic laboratory services will be denied as non-covered. UnitedHealthcare sent communications to all diagnostic providers to encourage them to become a Designated Diagnostic Provider by completing a quality questionnaire.

Visit the CAP’s private sector advocacy webpage for more information.

Ohio Pathologists Force Favorable Vote at State HOD

The Ohio Society of Pathologists (OSP), with CAP support, successfully argued for passage of a Ohio State Medical Association (OSMA) House of Delegates (HOD) resolution to compel that organization to reconsider their past support for an Ohio out-of-network payment law in light of the enactment of the federal "No Surprises Act." Working with state societies, the CAP advocates for state laws to require health plans to have adequate networks of hospital-based physicians, including pathologists. The CAP’s strong partnerships with societies like the OSP bolsters advocacy efforts at the state level.

On April 10, the OSMA House of Delegates, in a final vote, while not endorsing the original OSP resolution, voted to direct and authorize the establishment of a multi-specialty working group of physicians to include all impacted specialties. The working group is charged to report back to the OSMA on the effects of the Ohio out-of-network law and "evaluate recommendations for further legislative advocacy." The OSP leadership crafted the authorizing language during HOD deliberations as a substitute amendment.

The vote on the final resolution was contentious, with some within OSMA arguing against consideration of any legislative action to repeal or revise the Ohio out-of-network law that ties payment to the median in-network rate of the health plan payer, or 100% of Medicare, whichever is greater. By contrast, the recently enacted federal No Surprises Act law contains no adverse payment formula. Moreover, the 100% Medicare benchmark in the Ohio law is the lowest nationwide and was opposed by the OSP and CAP. The OSP is looking forward to participating in the newly created OSMA working group.

Advocacy Win: Congress Delays 2% Medicare Cut Until End of 2021

Because of CAP advocacy and support from the American Medical Association (AMA) and other medical professional groups, Congress finalized the bipartisan legislation that extended the moratorium on a 2% cut to physician Medicare payments until the end of 2021. The Centers for Medicare & Medicaid Services (CMS) will now release all claims held since the start of April. Following congressional action, President Joe Biden signed the bill into law on April 15.

On April 13, the House voted on the legislation to delay the 2% cut from April 1, 2021, to December 31, 2021. The legislation previously passed the Senate by a strong bipartisan margin. The CAP had asked its members to contact their elected officials to support the legislation. About 425 pathologists sent 1,408 messages to 319 members of Congress in support of this legislation through the CAP Action Center. And because of our members’ actions and CAP advocacy, Congress pushed the moratorium until the end of 2021. The moratorium on Medicare sequestration was originally slated to expire on April 1, 2021 per previous legislation.

In a March 15 letter, the CAP strongly called for bipartisan action to stop the Medicare budget sequester cuts and provide critical relief for pathologists who have been on the front lines to fight the pandemic. Additionally, the AMA, the CAP, and 127 medical and state organizations lobbied Congress to relieve the financial burdens of the COVID-19 pandemic on physicians during the current national emergency. In a February 12 letter to congressional leaders in the House and the Senate, the CAP joined the groups to support legislation that would suspend a 2% across-the-board cut.

The CMS held off on processing Medicare claims in April while Congress debated the legislation to avoid making reduced payments to providers. The CMS directed Medicare contractors to release any claims held in April because of the policy.

Congress originally paused the 2% Medicare sequester cuts as part of the Coronavirus Aid, Relief, and Economic Security (CARES) Act in 2020 as providers started to struggle with the financial fallout of the COVID-19 pandemic. Sequestration is the automatic reduction of specific federal spending that was part of the Budget Control Act of 2011. Congress has often used extending the sequestration as a payfor for other pieces of legislation over the last ten years. Currently, the sequestration is expected to last until 2031.

CAP Opposes Cigna’s Plan to Deny Pay for Professional Component of Clinical Pathology

The CAP opposes a new payment policy announced by Cigna on April 12 to deny claims when the professional component (modifier 26) of clinical pathology is billed. The denials will take effect July 11. The CAP will engage with Cigna and ask for a meeting to further discuss the policy.

The change would affect pathologists in many states as CAP has been alerted to this issue by pathologists in Pennsylvania and California. Cigna also offers individual and family health insurance plans in Arizona, Colorado, Florida, Illinois, Kansas, Missouri, North Carolina, Tennessee, Utah, and Virginia.

The CAP maintains the professional component of clinical pathology services are critical to the reliable and accurate diagnosis and treatment of patients. For Cigna to discontinue reimbursement for these services will prove detrimental to patients, and the integrated delivery of care to which laboratory diagnostic services are central.

The CAP will keep its members informed on this issue as new developments are available. Go to our private sector advocacy webpage for more information.

CAP Urges Transparency, Medical Experts Review in New Medicare Coverage

In a communication to Medicare agency officials, the CAP continued to urge the CMS to ensure that Medicare coverage decisions will be by health experts through a transparent process based on medical evidence. Additionally, the CAP asked the CMS to include robust transparency in any process providing coverage for Medicare beneficiaries. The CAP is concerned that the new CMS coverage for innovative medical devices would increase regulatory burdens that would complicate the current coverage determination process.

In the April 14 letter to the CMS about the Medicare Program; Medicare Coverage of Innovative Technology and Definition of ‘Reasonable and Necessary’ interim final regulation, the CAP asked the CMS and its Medicare Administrative Contractors (MACs) to “adopt the least restrictive coverage policy so as not to inadvertently limit coverage or impede access for Medicare patients.

“We continue to urge CMS to grandfather current policies, including those that were included as part of negotiated rulemaking. This revised definition should not put our prior efforts to ensure meaningful coverage for key items and services in jeopardy. Equally important, we do not support allowing MACs to develop alternate approaches to address any or all of the considerations outlined in the final rule. Coverage should continue to be based on the steps outlined in Chapter 13 of the PIM regarding the process for attaining an LCD {Local Coverage Determination}.”

Additionally, the CAP said it appreciated that the CMS increased beneficiary access to newly FDA market-authorized treatments and increased coverage under the new voluntary pathway. However, the CAP called for additional flexibility in national coverage policies to allow for new technologies.

The CAP has supported the CMS’s proposal to classify the existing coverage determination policy definition of reasonable, including the proposed modification.

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