Advocacy Update

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• CAP Pushes Congress to Stop Medicare Cuts in Year-End Spending Deal
• COVID-19 Vaccines Administered to Health Care Personnel, Long-Term Care Patients
• Transition: Who Will Lead Important Health Care Committee in the House of the 117th Congress
• CMS Will Offer Extreme, Uncontrollable Exemption Option for 2021 MIPS Year
• CAP Urges Medicare Advisory Panel to Ensure Accurate Clinical Lab Reimbursement Rates
• FDA Authorizes LabCorp’s Consumer COVID-19 Test Without Prescription
• Ohio Pathologists, CAP Oppose Out-of-Network Legislation
• Missed Our Medicare Fee Schedule Webinar? Watch the Recording
• Test Your Round-Up of Advocacy News Knowledge
• Breaking Advocacy News: Check out the Advocacy Twitter Channel

With Congress maneuvering to complete its year-end business before the holidays, the CAP lobbied congressional lawmakers and staff to stop -9% Medicare cuts to pathologists in 2021. Progress has been made with gaining support amongst lawmakers to stop or mitigate the cuts to pathologists and other specialty physicians next year.

At the same time, key congressional health care committee leaders agreed to a legislative compromise on surprise medical bills that now includes several of the CAP’s policy priorities. The changes agreed to by congressional lawmakers reflect more than two years of lobbying by the CAP and a physician coalition that improved legislation that was once one-sided and favored the interests of the insurance industry.

Stopping Medicare Cuts to Pathologists

At this article’s deadline, a final agreement had yet to be reached. On December 11, Sen. John Boozman (R-AR) introduced The Holding Providers Harmless from Medicare Cuts During COVID-19 Act of 2020. The legislation, which is a companion bill to legislation introduced in the House, would hold pathologists and other physicians harmless from the Medicare cuts for two years. In 2021, overall Medicare payments to pathologists are scheduled to decrease by -9%. The CAP has strongly opposed the cuts. CAP members have contacted their federal legislators to fight the Medicare cuts throughout the year.

Already, 51 senators have signed a letter to Senate leadership expressing their support to stopping the cuts.

The CAP remains engaged with congressional staff on the importance of passing legislation to stop the Medicare payment cuts from hitting pathology services next year. More updates on congressional news will be reported in the next edition of Advocacy Update and our Advocacy Twitter feed.

Success on Surprise Medical Bills

On December 11, the Senate Health, Education, Labor, and Pensions (HELP) Committee and House Energy and Commerce, Education and Labor, and Ways and Means committees agreed to language for a draft No Surprises Act bill. Importantly, the legislation would hold patients harmless from bills for out-of-network services provided at in-network hospitals or facilities once enacted. The CAP also notes the following provisions which it strongly advocated for inclusion:

• An independent dispute resolution (IDR) process with no minimum dollar amount threshold to access IDR and an option to batch claims together.
• Insurers will make payments for out-of-network services that is determined either through negotiation between the physician and insurer or the independent dispute resolution process.
• Will not interfere with state-level laws already enacted to address out-of-network services.
• Require a study on adequacy of provider networks by the Government Accountability Office.

Leaders of the House and Senate are negotiating whether the legislation can pass before the end of the year.

Americans began receiving COVID-19 vaccinations on December 14 after the Food and Drug Administration (FDA) approved emergency use of the Pfizer-BioNTech COVID-19 vaccine. Following the Centers for Disease Control and Prevention (CDC) recommendations for the initial phase of the COVID-19 vaccination, health care personnel and residents of long-term care facilities first received the vaccines.

Pathologists and laboratory personnel are included in this definition of health care personnel, which the CDC defines as “paid and unpaid people serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials.” And, based on guidance published earlier this year by the Department of Homeland Security Cybersecurity and Infrastructure Agency, “workers, including laboratory personnel, that perform critical clinical, biomedical and other research, development, and testing needed for COVID-19 or other diseases” were identified as essential critical infrastructure workers.

Each state will have different vaccination plans with partners to administer the vaccine. As vaccine availability increases, the government’s recommendations will expand to include more groups.

Editor's Note: Advocacy Update will feature stories about the upcoming transition to the Biden Administration and new Congress. These stories will highlight major news on the future of President-elect Joe Biden's cabinet, other administrative officials, and both chambers of Congress that will enact and execute new health care policies affecting pathologists, their laboratories, and the patients they serve.

The 117th Congress will officially take office on January 4, 2021, the Democratic party will retain its majority with 222 House seats, with 209 seats for the Republicans. The CAP expects several leadership changes on key House congressional committees overseeing Medicare, Medicaid, and health care that will be pertinent to the CAP's advocacy strategy.

In the House Committee on Energy and Commerce, Democrat Chairman Rep. Frank Pallone, (D-NJ) will keep control of his seat, and Republican Rep. Cathy McMorris Rodgers (R-WA), will be the Ranking member.

For the House Committee on Ways and Means, Democrat Rep. Richie Neal (D-MA) will continue to serve as Chair as well as Republican Rep. Kevin Brady (R-TX) will continue to serve as ranking member. Democrat Rep. Lloyd Doggett (D-TX) will most likely continue to serve as Health Subcommittee chair.

Finally, on the House Committee on Education and Labor, Democrat Rep. Bobby Scott (D-VA) will most likely remain as chair and Republican Rep. Virginia Foxx (R-SC) will remain as ranking member.

Citing the strains of the current pandemic on physician practices, the Centers for Medicare & Medicaid Services (CMS) announced it would offer its “Extreme and Uncontrollable Circumstances” policy for eligible clinicians unable to meet requirements for the 2021 Merit-based Incentive Payment System (MIPS).

Earlier in 2020, the CMS created its Extreme and Uncontrollable Circumstances policy to allow MIPS eligible physicians and other clinicians the ability to request to reweigh one or more 2020 MIPS performance categories to 0% due to the current COVID-19 public health emergency. The CMS anticipates the public health emergency will continue well into 2021 and many physician practices will not be able to participate. In the final 2021 Quality Payment Program regulation released on December 1, the CMS said the policy would continue for the next MIPS performance year. The CMS expects the application to be open for practices in the of Spring 2021.

The CMS also said many physicians will opt to report MIPS data despite the pandemic. The CAP notes that many pathology practices, especially those enrolled in the Pathologists Quality Registry, have used the data to improve contracting positions with health insurance payers and hospitals. In 2019, 100% of the CAP’s registry participants were eligible for positive Medicare payment adjustments during 2021 from MIPS.

In addition, during the 2021 reporting year, more money will likely be available for those MIPS participants achieving an exceptional score. A $500 million pool is split between participants with these scores and with likely fewer physicians participating, by applying for the Extreme and Uncontrollable Circumstances policy, it’s anticipated that disbursements will increase.

If you have questions about this process or other aspects of the MIPS program, email the CAP’s experts at mips@cap.org.

The CAP expressed concerns to the Medicare Payment Advisory Commission (MedPAC) regarding accurate clinical laboratory reimbursements rates in response to the public meeting in September. The CAP asked that any recommendations to the Centers for Medicare & Medicaid Services (CMS) clinical laboratory fee schedule (CLFS) rates under the Protecting Access to Medicare Act (PAMA) must ensure a broad representation of the laboratory market and accurate payment rates.

In a December 3 letter to MedPAC, the CAP said it is “significantly concerned about the impact any failure in collecting accurate [laboratory] data will have on quality patient care and access to medically necessary laboratory testing.” The CAP also stated that “private payers are, as was noted during the discussion, being aggressive in terms of negotiating rates for laboratory tests, while pathology practices and laboratories across the country continue to face increasing regulatory burden and ongoing public health crises including the COVID-19 public health emergency.”

On September 3, the MedPAC convened a public meeting to discuss the methodology the CMS uses to set private payer-based rates for laboratory tests under PAMA. MedPAC has been tasked by Congress to issue recommendations to the CMS on PAMA implementation by June of next year. MedPAC is an independent federal group that periodically produces reports and nonbinding recommendations to Congress on the Medicare program.

The 2014 PAMA required the CMS to establish those rates based on what private payers paid. PAMA requires applicable laboratories to report private payer rates for clinical laboratory services to the CMS, using the data to calculate Medicare reimbursement rates for tests on the clinical laboratory fee schedule. As a result of recent legislation, the next reporting period is required to begin January 1, 2022.

On December 10, the FDA issued an Emergency Use Authorization (EUA) to LabCorp for its Pixel COVID-19 Test Home Collection Kit for use with LabCorp’s COVID-19 RT-PCR Test.

The Pixel COVID-19 Test Home Collection Kit is the first COVID-19 direct-to-consumer (non-prescription) test system, allowing a person to self-collect a nasal sample in their home and then send the sample to LabCorp for testing. This at-home COVID-19 test system can be used by anyone aged 18 or over and can be purchased online or in a store without a prescription.

A health care provider delivers positive or invalid test results to the user by phone call. Users may access negative test results by an online portal or by email.

In November, the FDA also issued an EUA for the Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single-use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. That test was administered by prescription only, whereas the LabCorp test does not require a prescription. As noted in the EUA, prescribing health care providers are required to report all test results they receive from individuals who use the test to their relevant public health authorities by local, state, and federal requirements.

The Ohio Society of Pathologists (OSP) and the CAP opposed legislation negotiated by the state's medical society to pay for out-of-network services at 100% of the Medicare rate or the median in-network rate. The legislation has already passed the Ohio House and is pending in the Ohio Senate. The CAP’s partnerships with state pathology societies strengthen advocacy efforts at the state level.

On December 8, the Ohio Society of Pathologists President Sean Kirby, MD, FCAP, testified before the State Senate Insurance Committee outlining how, "applying the federal emergency services out-of-network payment formula, under the ACA, to non-emergency services, based upon the greater median in-network rates, the out-of-network rate, or 100% of Medicare was rejected in CA, NY, CO, NM, MI, NJ, WA, VA, FL, TX, AZ, NH, MN, and ME." Dr. Kirby further emphasized that “for non-emergency services, these states modified the payment safeguard to be a higher percentage of Medicare, or higher in-network rate, or retrospectively tied to a default date, or a ‘commercially reasonable’ rate…HB 388 potentially enhances the profit margin for insurance companies at the expense of patient care and health care delivery."

On December 1, the Ohio State Medical Association also testified in support of the bill, "While the substitute bill is not a perfect solution... our major concerns have been addressed..." If enacted into law, the Ohio bill would provide the lowest Medicare payment safeguard for out-of-network services in the nation. The OSP and CAP will continue to oppose the bill and request a veto. If the bill becomes law, the CAP and OSP will seek to revise the law in the next legislative session.

The CMS released final the 2021 Medicare Physician Fee Schedule and the Quality Payment Program regulations. The CAP hosted a webinar where experts reviewed the final regulation changes that will impact your pay, practice, and participation in the Merit-based Incentive Payment System (MIPS).

Missed the webinar? Check out the recording and download the slides.

Take the year-end December Advocacy News Quiz. See how you compare to your fellow CAP members by sharing your results on social media.

Take the December news quiz

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