Advocacy Update

Read the Advocacy Update

• CAP Advocacy Saves Pathologists $85 million in 2021 as Congress Mitigates Medicare Cut
• Pathologists Quality Registry Earns 2021 Approval to Improve Practice Performance, Payment
• CAP Urges Members to Get COVID-19 Vaccine
• CAP Asked for Provider Relief, HHS Responds with $24 Billion COVID-19 Funding
• CMS Issues Guidance for COVID-19 Point-of-Care Tests, CLIA Waivers
• FDA Authorizes Nasal Swab At-Home Rapid COVID-19 Test
• Insurer Price Transparency Regulation Starts January 1
• Save the Date: 2021 Pathologists Leadership Summit, May 1-4, 2021
• Test Your Year-End Advocacy News Knowledge

Following a sustained lobbying campaign against Medicare payment cuts to pathologists in 2021 by the CAP and a coalition of physician associations, Congress will mitigate the cut by adding $3 billion to next year’s Medicare fee schedule and delaying implementation of a new evaluation and management add-on code for three years (the implementation delay is expected to restore roughly 3% to pathologists each year). The result amounts to $85 million more for pathologists in 2021, according to an analysis by the CAP.

What was once a -9% Medicare cut to pathologists’ total reimbursement in 2021 has now been drastically reduced to an estimated -2.25% next year pending congressional action. On December 20, leaders in the House and Senate announced key provisions in a $900 billion COVID-19 relief package and a $1.4 trillion federal spending bill that will keep the government open through September 2021.

In addition to government spending bills and several measures providing financial relief to Americans, the year-end legislation included sections to mitigate and reduce the Medicare cut. The legislation passed by overwhelming margins in the House and Senate on December 21. And, President Donald Trump was expected to sign the legislation into law once the bill arrived on his desk.

Due to Medicare policy to increase reimbursement to evaluation and management services, an overall Medicare payment decrease of -9% to pathology services was scheduled to take effect to maintain budget neutrality. The CAP had strongly opposed the cuts and rallied CAP members to contact their federal legislators to fight the Medicare cuts throughout 2019 and 2020. Many elected officials in the House and Senate responded to our calls, as well as the calls from a broad coalition of physician associations that included the American Medical Association and the CAP, by supporting efforts to stop or mitigate the cut.

In another section of the legislation, Congress also delayed a -2% budget sequester cut to Medicare that was scheduled for January 2021. The cut is delayed for three months and would apply to Medicare services beginning April 1, 2021, unless Congress delays the cut further.

Additional Improvements Made to Surprise Billing Legislation
After a breakthrough agreement on surprise medical bills in early December, congressional leaders made further refinements to legislation to hold patients harmless from bills for out-of-network services provided at in-network hospitals or facilities.

Key provisions of the No Surprises Act, which has also been added to the year-end spending legislation, advocated for by the CAP include:

• An independent dispute resolution (IDR), or arbitration, process with no minimum dollar amount threshold to access IDR and an option to batch claims together.
• Removal of Medicare and Medicaid rates from consideration by the arbiter during the IDR process.
• Insurers will make payments for out-of-network services that is determined either through negotiation between the physician and insurer or the IDR 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.

The CAP has lobbied for more than two years to save patients from unexpected medical bills and support network adequacy requirements for health insurance plans.

More coverage of this congressional action will be reported in future editions of Advocacy Update and on our Twitter feed.

On December 18, the College of American Pathologists’ (CAP’s) Pathologists Quality Registry once again received its qualified clinical data registry status from the Centers for Medicare & Medicaid Services (CMS). This recognizes our registry’s ability to improve care for patients and collect quality data to submit for the Merit-based Incentive Payment System (MIPS). The Pathologists Quality Registry reduces pathologists’ burdens when participating in MIPS by providing practice-specific guidance, consolidating reporting for both the Quality and the Improvement Activities categories and providing pathology practices with real-time performance benchmark reports.

“Quality diagnostic patient care is at the foundation of the CAP’s mission,” said CAP President Patrick Godbey, MD, FCAP. “Our Pathologists Quality Registry guarantees that pathologists have the best qualified clinical data registry for continuous quality improvement. It helps us improve our practices and successfully fulfill the requirements of Medicare’s Merit-based Incentive Payment System. Our registry enhances the pathologist’s ability to get paid fairly for the value he or she provides to Medicare patients.”

To support pathologists, the Pathologists Quality Registry offers pathology-specific quality measures and the ability to integrate with a practices’ laboratory information system or billing system for automated and simplified data collection for practices that prefer not to use the web data entry tool. The registry will offer a choice of 15 quality reporting measures, most of which are exclusively available in the Pathologists Quality Registry. Moreover, the CAP’s expert staff can guide participants through the measure selection and reporting process.

The CMS is offering, again for 2021, its Extreme and Uncontrollable Circumstances policy for eligible clinicians unable to meet requirements for the MIPS program in 2021, but they also said many physicians will opt to report MIPS data. Despite the potential exemption, almost 1,000 pathologists are using the CAP’s registry. Since its inception, 100% of the CAP’s registry participants submitting MIPS data have been eligible for positive adjustments. Pathology practices enrolled in the Pathologists Quality Registry, have also used the data to improve contracting positions with health insurance payers and hospitals.

As physicians and health care professionals from around the United States begin to receive the COVID-19 vaccine, the College of American Pathologists urged pathologists and laboratory professionals to take advantage of this access during the initial phase of the vaccine’s distribution as they continue their heroic efforts against the pandemic.

“Stopping this pandemic requires our health care system to utilize all the tools we have available and the COVID-19 vaccine is an important one,” said CAP President Patrick Godbey, MD, FCAP. “Vaccine development in the United States is a rigorous process rooted in evidence and scientific protocols. The clinical trials for the vaccine have also included diverse communities to ensure safety and efficacy for our patients. It is essential that early access to the vaccine be provided to all pathologists and laboratory personnel. Pathologists have led throughout this pandemic by bringing tests for the coronavirus online in communities across the country and we must ensure that patient access to testing continues. We must also serve as a resource to discuss the facts about the vaccine and answer questions patients, family members, and friends have about why they should get the vaccine when it is available to them.”

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 once approved by the Food and Drug Administration. 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.”

Other medical industry groups such as the American Hospital Association and the American Medical Association encouraged their members to get the vaccine as well, to protect themselves and the nation from COVID-19.

The CAP encourages pathologists to post images about their own vaccination experience and use the hashtag #igottheshot in their social media posts.

The Department of Health and Human Services (HHS) is distributing additional funds to 70,000 physicians and other providers through the Provider Relief Fund. The CAP has advocated for financial relief for pathologists and laboratories suffering economic hardships due to the COVID-19 pandemic.

The fund will allocate $24.5 billion, which is more than the $20 billion in the original allocation. This funding will distribute to providers up to 88% of their reported lost revenues and net change in expenses caused by the coronavirus pandemic during the first half of 2020.

Payment distribution started on December 16 and will continue through January 2021.

The CAP had asked the HHS to give pathologists and laboratories support through the relief funds. In addition to the baseline payment of 2% of annual revenue from patient care, the HHS changed its phase 3 distribution to consider the actual revenue losses and expenses experienced by providers. The HHS found submissions for lost revenues and net expense changes would exceed the $20 billion budgeted for the phase 3 allocation and added $4.5 billion to available funds.

The HHS provided a state-by-state breakdown on the first batch of phase 3 payments. The HHS has also published several resources, and the CAP is here to help. The CAP encouraged pathologists to apply for these federal programs when eligible and we have provided CAP members with resources with information about the program.

Provide us with your feedback and additional questions about these financial programs by emailing the CAP at smallbusiness@cap.org.

The Centers for Medicare & Medicaid Services (CMS) on December 14 released updated guidance and resources for laboratories conducting COVID-19 point-of-care testing and updates for facilities that applied for a CLIA Certificate of Waiver.

The CMS also updated its question and answers document that guides the temporary enforcement discretion for any facility that has applied for a CLIA Certificate of Waiver. The guidance also applies to facilities that perform SARS-CoV-2 point-of-care testing but do not have a CLIA number.

According to the CMS, laboratories must be CLIA-certified if they perform point-of-care SARS-CoV-2 testing. Facilities that submitted a CLIA 116 application for a waiver certificate must check with their state agency before testing. States may have more stringent licensure requirements that the facility must meet before point-of-care testing can begin. However, facilities that have applied for a CLIA waiver to perform SARS-CoV-2 point-of-care testing may conduct the tests and report patient results as soon as they have submitted their application to their state agency.

Below are additional resources

• Interim Guidance for Rapid Antigen Testing for SARS-CoV-2
• Frequently Asked Questions about Coronavirus for Laboratories
• Clinical Laboratory COVID-19 Response Calls
• CDC Laboratory Outreach Communication System (LOCS)
• COVID-19 Information for Laboratories
• CDC COVID-19 website

On December 15, the Food and Drug Administration (FDA) granted emergency authorization to an over-the-counter, at-home test for COVID-19.

Unlike previous home tests, this version does not require samples to be sent to a laboratory and can be taken without a doctor’s order. For this at-home test, people will swab their nose and then use a “Bluetooth connected analyzer” to send the results to their smartphone. The COVID-19 test was developed by Australian company Ellume.

The company said it plans to have 20 million tests available in the United States in the first half of 2021. The FDA said 3 million tests would be produced in January.

The HHS’ new price transparency regulations will go into effect on January 1, 2021. The CAP has supported patient access to appropriate price information for medical services but stressed the complication of determining the cost of diagnostic services and ensuring compliance with reporting requirements. The new regulations mostly affect administrators who are typically tasked with compliance, but pathologists should be aware of the requirements.

Hospitals are required to provide publicly accessible standard charge information online about the items and services they provide in two ways:

• Comprehensive machine-readable file with all items and services
• Display of 300 shoppable services in a consumer-friendly format

The Centers for Medicare & Medicaid Services (CMS) will audit a sample of hospitals for compliance starting in January, in addition to investigating complaints that are submitted to the CMS and reviewing analyses of non-compliance, and hospitals may face civil monetary penalties for noncompliance. The CMS monitoring activities may include, but would not be limited to, the following, as appropriate:

• Evaluation of complaints made by individuals or entities to the CMS
• Review of individuals’ or entities’ analysis of noncompliance
• Audit of hospital websites

On October 28, the HHS issued a final regulation on health care price transparency where the CAP had urged HHS to consider the complexities of pathology practices as the agency implements changes. The final regulation requires most group health plans, including self-insured plans, and health insurance issuers to disclose price and cost-sharing information to patients. While the CAP supports patient access to appropriate price information, the CAP is concerned about potential for risk stemming from delays in determining the cost of pathology services in advance or prior to the delivery of the services.

The CAP encourages pathologists to visit the Hospital Price Transparency website for additional information and resources to help hospitals prepare for compliance, including:

• FAQs
• 8 Steps to a Machine-Readable File
• 10 Steps to a Consumer-Friendly Display
• Quick Reference Checklists

The Pathologists Leadership Summit will be held from May 1 through the 4, 2021. This is a dynamic experience focused on helping CAP members advocate to protect the future of pathology and advance their leadership skillset to the next level of performance. Get updated on what you need to know today to effect positive change and make a bigger difference tomorrow. This meeting is exclusively available to CAP members including CME.

This is the last week to take the December Advocacy News Quiz. Last month, over 80 pathologists took the quiz. See how you compare against your fellow CAP members’ in the December News Quiz

Take the December news quiz