Advocacy Update

Read the Latest Issue of Advocacy Update

June 16, 2020

In this Issue:

CAP, AMA Fight to Protect Physician Scope of Practice

The American Medical Association (AMA), the CAP, and several other medical societies asked the Centers for Medicare & Medicaid Services (CMS) to reconsider changes to the scope of practice provisions in the proposed 2021 Inpatient Rehabilitation Facility (IRF) Prospective Payment System (PPS) regulation.

In a June 11 letter to CMS Administrator Seema Verma, the physician groups opposed changes that would allow the use of non-physician practitioners to perform the IRF services and documentation requirements currently performed by rehabilitation physicians. The groups asked that the CMS “uphold the role of the rehabilitation physician in delivering and overseeing care for patients in IRF settings.”

While the physician groups recognize the role that non-physician providers, such as nurse practitioners and physician assistants, play in providing care to patients, their “skillset is not interchangeable with that of fully-trained rehabilitation physicians.” Importantly, the group noted that by expanding the scope of practice sets a dangerous precedent for removing physician supervision requirements across all health care settings.

The group also emphasized that “the potential cost savings estimated by the CMS and purported reductions in burden” do not outweigh the risks. Additionally, the group expressed concerns that the risks to these vulnerable patients may contribute to increased health care costs.

The CAP actively monitors and engages in the scope of practice issues. For more, visit www.cap.org/advocacy/laboratory-and-political-action/scope-of-practice.

FDA Grants EUA for NGS COVID-19 Test

On June 10, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to Illumina, Inc. for the first COVID-19 diagnostic test that uses next-generation sequence technology. The FDA authorized the Illumina COVIDSeq Test for the qualitative detection of SARS-CoV-2 RNA from respiratory specimens collected from COVID-19 patients.

Emergency use of the diagnostic is limited to CLIA authorized laboratories to perform high complexity tests. The EUA was based on the public health emergency declared on February 4 by the Secretary of the US Department of Health and Human Services (HHS).

According to Illumina, Inc., COVIDSeq is a qualitative test that can detect SARS-CoV-2 RNA using "nasopharyngeal swabs or oropharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal wash/aspirates, nasal aspirates, and bronchoalveolar lavage specimens.”

Next-generation sequencing is a type of diagnostic technology that can determine the genetic sequence of a virus. Comparing sequencing results over time can help scientists understand if and how viruses mutate. Illumina, Inc. is required to evaluate analytical sensitivity and reactivity of the product using FDA-recommended reference materials, as well as monitor adverse events, including false results, for reporting to the FDA.

AMA, CAP Ask Congress for Liability Protections During Pandemic

The AMA, the CAP, and several other medical societies urged congressional leaders to include liability protection for physicians in the next COVID-19 relief legislation. Specifically, in a letter from the AMA, which was signed by dozens of associations, including the CAP, physicians urged Congress to include “targeted and limited liability protections that are in the bipartisan bill, HR 7059, the Coronavirus Provider Protection Act.”

Due to changing policies during the COVID-19 pandemic, front line, supporting physicians and other providers have faced unprecedented pressure to provide care outside their expertise area and rationed care due to supplies and equipment shortages. Therefore, “physicians face a greater threat of costly and emotionally draining medical liability lawsuits due to circumstances that are beyond their control,” according to the letter.

The physician groups asked Congress not to provide universal liability protection, but targeted and limited liability protections where “health care services are provided or withheld in situations that may be beyond the control of physicians/facilities (eg, following government guidelines, directives, and lack of resources) due to COVID-19.”

Archives Features Quality Payment Program Special Section

The June edition of Archives of Pathology and Laboratory Medicine features articles about Medicare’s Quality Payment Program (QPP) written by CAP experts. This special section of Archives provides an understanding of the QPP program for pathology practices to comply with the program’s requirements, including those concerning the Merit-based Incentive Payment System (MIPS). The articles in this special section are:

Additionally, the CAP has updated its Quality Payment Program for Pathologists web page to include the latest resources and tools to reduce the reporting burden faced by pathologists. The new Quality Payment Program for Pathologists web page features sought-after key QPP resources, information on eligibility and preparedness, reporting requirements, timeline, and information on how to contact CAP staff experts. There is also a direct links to the Pathologists Quality Registry.

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Test Your Advocacy News Knowledge

It’s June, and it’s time to test your CAP Advocacy News Quiz. Last month, over 100 pathologists took the quiz. See how you compare against your fellow CAP members’ in the June News Quiz. Take the June news quiz.