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Quarterly Advocacy Update

Keeping you informed on policy issues affecting pathology and laboratory medicine.

Recap of the Latest Advocacy News from January-March 2021

In this Issue:

Senate Passes CAP-Supported Moratorium on Medicare Cuts

On March 25, the Senate passed CAP-supported legislation to prevent a 2% cut from hitting physician Medicare payments until the end of 2021. The 2% cut is set to take effect on April 1. The Senate legislation extends the Medicare sequester moratorium through the end of the year, but the bill does not include a House provision that would also stop additional sequester cuts created by the recently approved American Rescue Plan. The Senate legislation, which passed 90-2, will have to go back to the House for a vote once the lower chamber returns from recess in April.

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President Biden Signs American Rescue Plan Providing $48 Billion for COVID-19 Testing

On March 11, President Biden signed into law the American Rescue Plan that includes $48.3 billion for COVID-19 testing. The new law enables the Department of Health and Human Services (HHS) to use the new funding for COVID-19 testing programs in its national strategy. In addition, the law also expanded COVID-19 vaccination efforts and included other key health care provisions supported by the CAP.

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How the CAP Shaped Surprise Billing Legislation with its Advocacy

After the passage of the No Surprises Act, legislation that addressed surprise medical bills in December, the CAP reviewed the final law and will remain engaged in the law’s implementation. As the legislation evolved last year, CAP members met with their federal lawmakers to discuss the CAP’s policy priorities. Through the CAP’s engagement and collaboration with other physician associations, the legislation improved drastically as a result of our influence.

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Download the CAP’s Updated Impact Table on the 2021 Medicare Physician Fee Schedule

Because of the CAP’s advocacy efforts, pathologists will save up to $85 million in 2021. The CAP’s efforts reduced the -9% Medicare cut to approximately -2 to -3% to pathologists, amounting to between $76 to $85 million more for pathologists in 2021. Congress mitigated the cut by adding $3 billion to the 2021 Medicare Physician Fee schedule and delayed the implementation of a new evaluation and management add-on code for three years. The CAP updated its the 2021 Medicare Physician Fee Schedule Impact Table based on the new rates. The original proposed a -9% Medicare cut to pathologists’ has now been drastically reduced.

CAP Responds to White House COVID-19 Plan, Outlines Pathologists’ Priorities

The CAP outlined its priorities to fight the COVID-19 pandemic following the release of the White House’s National Strategy for the COVID-19 Response and Pandemic Preparedness. The CAP has engaged with the new Biden administration as its plan to leverage the federal government to counter the current pandemic has taken shape, especially those elements of the new strategy concerning diagnostic testing.

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CAP Welcomes Release of National COVID-19 Response Plan

On January 21, President Joe Biden signed several executive orders to create a Pandemic Testing Board and address other issues concerning COVID-19 testing. The CAP applauded these actions as it engages with the new administration on pathologists' health care policy priorities. Additionally, President Biden released a National Strategy for the COVID-19 Response and Pandemic Preparedness, which the CAP also welcomed as a comprehensive plan that coordinates critical diagnostic testing.

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New Survey Reveals Almost Half of Labs Can’t Get Enough COVID-19 Testing Supplies

A new CAP survey of board-certified pathologists nationwide showed that less than half, or 45% of laboratories testing for COVID-19 still have difficulties obtaining the testing supplies they need. While this represents an improvement since last summer, shortages still represent a significant burden on those laboratories diagnosing coronavirus disease and require national attention to mitigate disruptions.

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CAP Meets with Top FDA Officials to Discuss COVID-19 Testing

The Food and Drug Administration’s (FDA) leadership convened the meeting on March 1 to update the laboratory community on the current state of their COVID-19 activities. Acting FDA Commissioner Janet Woodcock, MD, and Jeff Shuren, MD, Director of the Center for Device and Radiological Health reinforced that career officials would make regulatory determinations based on science not politics.

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CAP Advocacy Win: Biden Administration Increases COVID-19 Testing Funds

The White House expanded resources for COVID-19 testing after calls by the CAP for assistance to address supply shortages. On February 17, the Biden Administration announced that the Department of the Health and Human Services (HHS) released $650 million in resources to expand testing, increase manufacturing of testing supplies, and support genomic sequencing. Previously, the CAP had engaged with the Biden administration on its COVID-19 pandemic strategy and encouraged the government to increase testing and supplies resources.

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Becerra Confirmed as HHS Secretary

California Attorney General Xavier Becerra was confirmed as Secretary of Health and Human Services (HHS) by the Senate on March 18. He was approved by a vote of 50 to 49, becoming the first Latino Secretary of HHS, the largest federal department in terms of spending.

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Biden Nominates Brooks-LaSure for CMS Administrator

On February 17, President Joe Biden nominated Chiquita Brooks-LaSure, a former appointee from the Obama administration, to be the next administrator of the Centers for Medicare & Medicaid Services (CMS).

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Who Will Lead Important Senate Health Care Committees in the 117th Congress

As the 117th Congress took office in early January, Democrats will now be in control of both the House and the Senate, where they will now hold a slim majority. The Democrats gained control in the Senate with the addition of two Senators elected from Georgia on January 5. The Senate will be split with 50 senators caucusing with Democrats and 50 senators caucusing with Republicans, but Vice President–elect Kamala Harris will break ties on votes cast following political party lines. The CAP expects several leadership changes on key congressional committees overseeing Medicare, Medicaid, and health care that will be pertinent to the CAP's advocacy strategy in the Senate.

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CAP Obtains More Clarification on UnitedHealthcare’s Designated Diagnostic Provider Program

Effective July 1, 2021, and subject to state regulatory approval, the insurer UnitedHealthcare is launching a new benefit design where outpatient diagnostic laboratory services will only be covered for fully insured commercial plan members when they are delivered by a “Designated Diagnostic Provider.” The CAP initially met with UnitedHealthcare (UHC) leaders on February 19 to discuss the insurer’s upcoming plan changes and address a number of concerns. In response to CAP member questions, the CAP met again with UnitedHealthcare on March 22 to secure additional clarification on the Designated Diagnostic Provider program.

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UnitedHealthcare Deadline Flexibility for Designated Provider Program

The CAP followed up with UnitedHealthcare leaders to discuss the insurer’s upcoming plan changes and the newly-announced Designated Diagnostic Provider laboratory program. While the February 28 deadline for laboratories to submit a quality questionnaire passed, UnitedHealthcare officials confirmed to the CAP that they would be flexible on that deadline, and CAP members can contact ddp_lab@uhc.com with concerns and questions.

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NJ Pathologists, CAP Fight for Network Adequacy

The New Jersey Society of Pathologists (NJSP) and the CAP worked closely with the New Jersey Physician Coalition to advocate for increased network adequacy requirements for health plans. The NJSP and the CAP introduced legislation that requires network adequacy in health plans for pathologists and other specialty physicians. The CAP has worked with the NJSP to ensure that New Jersey health plan networks are inclusive of pathologists to reduce surprise bill incidents for patients.

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Ohio Pathologists, CAP Seek Revision to Out-of-Network Reimbursement

The Ohio Society of Pathologists (OSP) and the CAP asked the Ohio State Medical Association (OSMA) House to seek revisions to the payment for out-of-network services and adopt a specific policy requiring health plan network adequacy hospital-based physicians by specialty. The CAP has worked closely with the OSP to advocate on requiring health plans to have adequate networks of hospital-based physicians, including pathologists.

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Advocacy Win: Two Autopsy Bills Supported by Mississippi Pathologists, CAP Signed Into Law

Mississippi Gov. Tate Reeves signed two crucial forensic pathology laws that the Mississippi Association of Pathologists (MAP) and the CAP worked together on to protect the scope of practice for pathologists and eliminate regulatory burdens. The CAP’s strong partnership with the MAP reinforces advocacy efforts to ensure the scope of practice policies are applied at the state level.

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Rhode Island Pathologists, CAP Oppose Genetic Counselors Interpreting Test Results

The Rhode Island Society of Pathologists (RISP) and the CAP are working together to oppose a bill in the Rhode Island state house that would infringe upon pathologists’ scope of practice and allow genetic counselors the ability to interpret genetic tests. The RISP and CAP are committed to protecting pathologists’ scope of practice and ensuring laboratory personnel and genetic counselors' scope of practice are consistent with their education and training.

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Arizona Pathologists, CAP Secures Amendment in Genetic Testing Legislation

The Arizona Society and Pathologists (ASP) and the CAP successfully amended state legislation to protect Arizona pathologists’ scope of practice who conduct genetic testing. The amendment included in the state house bill proposes to regulate non-medical testing with no impact on medical genetic testing, which would cause legal confusion and increase reporting burdens for Arizona pathologists. The amendment will protect pathologists from great legal confusion and regulatory burdens in Arizona.

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CAP Urges Missouri House to Revise Autopsy Bill

The CAP urged Missouri State House to clarify technical concerns with a current autopsy state house bill where only pathologists are the ones who conduct or oversee autopsies and how to communicate with the deceased family after the autopsy. Through its state advocacy program, the CAP lobbies state legislatures to ensure that pathologists have a scope of practice consistent with their education and training.

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CAP Cautions FDA on Digital Pathology Deregulations

The CAP urged the Food and Drug Administration (FDA) to cautiously proceed with new regulations and increase flexibility for digital pathology devices under premarket notification requirements. In a March 15 letter, the CAP cautioned against moving forward with three of four digital pathology product codes because it may result in unintended consequences.

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Relentless CAP Advocacy Wins MIPS Relief for Pathologists; No Medicare MIPS Penalties During Pandemic

The CMS will not enforce reporting penalties for 2020 reporting due to the COVID-19 public health emergency. The CMS will apply the Extreme and Uncontrollable Circumstances Hardship Exception policy to all MIPS eligible clinicians who do not submit any MIPS data for the 2020 performance period and avoid a 2022 payment penalty. This will include physicians, including pathologists, who will be held harmless from up to 9% Merit-based Incentive Payment Program (MIPS) penalties. The CAP has advocated to reduce reporting burdens for pathologists and asked for relief from MIPS penalties.

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Final Medicare Medical Device Coverage Policy Includes Changes Sought by CAP

On January 12, the CMS issued its final regulation Medicare Coverage of Innovative Technology and Definition of “reasonable and necessary.” At the CAP’s urging, this final regulation established a Medicare coverage pathway to provide Medicare beneficiaries with faster access to new, innovative medical devices designated as a breakthrough by the Food and Drug Administration (FDA). The CAP sought Medicare coverage that would not complicate or circumvent the current coverage determination process.

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CAP Agrees with Medicare Improvements to Address Burdens in Prior Authorization

In December, the CMS released a proposed regulation to improve the electronic exchange of health care data and streamline processes related to prior authorization. The CAP urged the CMS to move forward with changes that streamline prior authorization requests and ensure expedited prior authorization timeframes but expressed concern about the continued burden and challenges related to prior authorization for pathology.

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