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Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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Multiple Pathology and Other Healthcare Organizations Request CDC Include Clinical Laboratory Personnel in First Round of COVID-19 Vaccinations

CAP president maintains medical laboratory staff are ‘indispensable’ in pandemic fight and should be in ‘top tier’ for vaccination

As COVID-19 vaccinations continue to roll out, the College of American Pathologists (CAP) is lobbying for clinical pathologists and medical laboratory staff to be moved up the priority list for vaccinations, stating they are “indispensable” in the pandemic fight.

In a news release, CAP’s President Patrick Godbey, MD, FCAP argued for the early vaccination of laboratory workers, “It is essential that early access to the vaccine be provided to all pathologists and laboratory personnel,” he said. “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.”

In a phone call following a virtual press conference, pathologists and CAP President Patrick Godbey, MD (above), told MedPage Today that even if medical laboratory staff are not directly in contact with patients, they should be considered “top tier” (designated as Phase 1a) for getting the vaccine. “I think they [clinical laboratory workers] should be considered in the same tier as nurses,” said Godbey, who also is Laboratory Director at Southeastern Pathology Associates and Southeast Georgia Health System in Brunswick, Ga. “They’re indispensable. Without them, there’d be no one to run the tests.” (Photo copyright: Southeast Georgia Health System.)

Who Does CDC Think Should Be First to Be Vaccinated?

According toThe New York Times (NYT), there are an estimated 21 million healthcare workers in the United States, making it basically “impossible,” the NYT wrote, for them all to get vaccinated in the first wave of COVID-19 vaccinations.

A December 11, 2020, CDC Morbidity and Mortality Weekly Report, titled, “ACIP Interim Recommendation for Allocating Initial Supplies of COVID-19 Vaccine—United States, 2020,” notes that “The [federal] Advisory Committee on Immunization Practices (ACIP) recommended, as interim guidance, that both 1) healthcare personnel and 2) residents of long-term care facilities be offered COVID-19 vaccine in the initial phase of the vaccination program.”

The ACIP report defines healthcare personnel as “paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials.”

However, a CDC terminology guidance document listed at the bottom of the ACIP report states, “For this update, HCP [Healthcare Personnel] does not include dental healthcare personnel, autopsy personnel, and laboratory personnel, as recommendations to address occupational infection prevention and control (IPC) services for these personnel are posted elsewhere.”

On December 16, the American Society for Clinical Pathology (ASCP) called attention to this discrepancy by sending a letter to CDC Director Robert R. Redfield, MD. The letter was co-signed by the:

In part, the letter stated, “We are convinced that ACIP did not intend to exclude any healthcare workers from its recommendation to offer vaccinations to healthcare personnel in the initial phase of the COVID-19 vaccination program (Phase 1a). However, we would hate for jurisdictions to overlook dental, autopsy, and laboratory personnel because of a minor footnote in [CDC] guidance that was developed for an entirely different purpose (i.e., infection control).

“We respectfully ask CDC to clarify,” the letter continues, “… that all healthcare workers—including dental, autopsy, and laboratory personnel—are among those who should be given priority access to vaccine during the initial phase of the COVID-19 vaccination program.”

Forgotten Frontline Healthcare Workers?

Clinical laboratory professionals continue to maintain they should be in the first priority grouping, because they are in direct contact with the virus even if they are not directly interacting with patients. In the CAP virtual press conference streamed on Dec. 9, 2020, Godbey; Amy Karger, MD, PhD, faculty investigator at the University of Minnesota and Medical Director of MHealth Fairview Point-of-Care Testing; and Christine Wojewoda, MD, FCAP, Director of Clinical Microbiology at the University of Vermont Medical Center, made their case for early vaccination of medical laboratory workers.

“In the laboratory, they are encountering and handling thousands of samples that have active live virus in them,” said Karger, who called clinical laboratory staff and phlebotomists the “forgotten” frontline healthcare workers. “We’re getting 10,000 samples a day. That’s a lot of handling of infectious specimens, and we do want [staff] to be prioritized for vaccination.”

Karger continued to stress the vital role clinical laboratories play not only in COVID-19 testing but also in the functioning of the overall health system. She added that staff burnout is a concern since laboratory staff have been working “full throttle” since March.

“From an operational standpoint, we do need to keep our lab up and running,” she said. “We don’t want to have staff out such that we would have to decrease our testing capacity, which would have widespread impacts for our health system and state.”

Testing for Post-Vaccine Immunity

The CAP panelists also highlighted the need to prepare for the aftermath of widespread COVID-19 vaccinations—the need to test for post-vaccine immunity.

“It’s not routine practice to check antibody levels after getting a vaccine but given the heightened interest in COVID testing, we are anticipating there is going to be some increased in demand for post-vaccine antibody testing,” Karger said. “We’re at least preparing for that and preparing to educate our providers.”

Karger pointed out that clinical pathologists will play an important role in educating providers about the type of antibody tests necessary to test for COVID-19 immunity, because, she says, only the SARS-CoV-2 spike protein antibody test will check for an immune response.

With the pandemic expected to stretch far into 2021, clinical laboratories will continue to play a crucial role in the nation’s healthcare response to COVID-19. As essential workers in the fight against infectious disease, clinical pathologists, clinical chemists, and all medical laboratory staff should be prioritized as frontline healthcare workers.

—Andrea Downing Peck

Related Information:

Pathologists Want First Crack at COVID Vaccines

The Rapidly Changing COVID-19 Testing Landscape

Some Health Care Workers Getting the Vaccine. Other’s Aren’t. Who Decides?

The Advisory Committee on Immunization Practices’ Interim Recommendation for Allocating Initial Supplies of COVID-19 Vaccine–United States, 2020

CDC Appendix 2-Terminology: Infection Control in Healthcare Personnel

ASCP Letter: COVID-19 Vaccination Playbook for Jurisdictional Operations

Prioritizing the COVID-19 Vaccine to Protect Patient Access to DiagnosticsCMS Changes Medicare Payment to Support Faster COVID-19 Diagnostic Testing

CMS Proposes a New Rule That Would Shift Many Procedures from High-Cost Inpatient Healthcare Settings to Lower-Cost Outpatient Ambulatory Surgical Centers

If the proposed rule becomes final, it may shift some inpatient medical laboratory testing away from hospital labs and to independent clinical laboratories

Medical laboratories in hospitals and health systems already feel the pinch of less test orders originating from their own emergency departments (ED). Now, more tests associated with inpatient care might also shift away from hospital labs due to a new proposed rule from the federal Centers for Medicaid and Medicare Services (CMS) that would move 1,740 specific procedures from inpatient care settings to outpatient ambulatory surgical centers (ACS).

Further, the proposed rule would completely phase out the “inpatient only” (IPO) list of services over a three-year transitional period, with total elimination of the IPO list by Calendar Year (CY) 2024.

If finalized as written, the rule (CMS-1736-P) would have a negative impact on the finances of hospitals laboratories as more patients get their care in outpatient settings instead of their local hospitals.

Conversely, hospital outreach labs that service ambulatory surgical centers and other outpatient settings could have an opportunity to pick up more medical laboratory test referrals.

The proposed rule, titled, “Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; New Categories for Hospital Outpatient Department Prior Authorization Process; Clinical Laboratory Fee Schedule: Laboratory Date of Service Policy; Overall Hospital Quality Star Rating Methodology; and Physician-Owned Hospitals,” was published in the Federal Register on August 12, 2020, and is open for comments until 10/05/2020.

Its summary reads: “This proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for Calendar Year (CY) 2021 based on our continuing experience with these systems.

“In this proposed rule, we describe the proposed changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system.

“Also, this proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. In addition, this proposed rule would establish and update the Overall Hospital Quality Star Rating beginning with the CY 2021; remove certain restrictions on the expansion of physician-owned hospitals that qualify as ‘high Medicaid facilities,’ and clarify that certain beds are counted toward a hospital’s baseline number of operating rooms, procedure rooms, and beds; and add two new service categories to the OPD [Outpatient Department] Prior Authorization Process.”

Moving from Highest Cost Settings to Lower Cost Settings

In the big picture, these changes can save Medicare money. By shifting procedures for Medicare patients from the highest cost settings—hospital inpatient—to lower cost settings, such as outpatient ambulatory surgical centers, and by eliminating the inpatient-only list, physicians have more leeway to determine for themselves whether a patient needs to be hospitalized for any given procedure.

In “Do Hospitals Have a Target on their Back?” healthcare coding and reimbursement consultant, Terry Fletcher, an editorial board member with ICD10monitor, wrote, “Last year, CMS proposed removing certain services from the inpatient-only list and making them available on an outpatient basis, which it said would help lower costs.

“According to the proposal, ambulatory surgical centers would get a payment increase of 2.6%, and CMS estimated total payments to them for 2021 will be about $5.45 billion, an increase of $160 million from this year,” she added.

Fewer Referrals for Inpatient Lab, More for Hospital Outreach Labs

The impact of the proposed rule is predictable—price shopping will ensue, which is what Medicare wants. Thus, with the removal of the inpatient-only procedure list, the clinical laboratories of hospitals and health systems will likely see a reduction in inpatient test orders. But clinical laboratories participating in hospital outreach programs may see an increase in test orders, as doctors transition to more outpatient procedures.

This seemingly simple shift may be more complicated than it appears, however, for both patients and labs. “In general, any routine test is going to be more expensive at a hospital,” Jean Pinder, founder and CEO of ClearHealthCosts, told

There may be other concerns as well. Convenience, insurance coverage, and physician recommendations often influence patient decisions about clinical laboratories.

Compares prices for common clinical laboratory and imaging tests charged
The chart above, taken from the article by, “compares prices for common clinical laboratory and imaging tests charged by an independent lab and local hospitals. These are charges that a person would pay without insurance reimbursements. Some University Hospitals prices in the chart differ from those on its website because some prices reflect inpatient, hospital-based services. Many factors can affect [a patient’s] final out-of-pocket costs, including health insurance coverage and individual aspects of your medical treatment.” (Graphic and caption copyright:

Change Is the Only Constant

The entire healthcare industry is undergoing change that is unlikely to end any time soon. Clinical laboratory managers who stay aware of trends in the industry and remain informed on regulatory changes, and who look for opportunities as the business landscape evolves, will have the best chance for guiding their labs to success.

That would certainly be true if CMS is able to publish a final rule that shifts a large number of procedures away from inpatient care and categorizes them as outpatient procedures.

Dava Stewart

Related Information:

CMS Proposed Rule (CMS-1736-P) Medicare Program

Do Hospitals Have a Target on their Back?

PAMA Price Reporting Update: Insights to Help Prepare to Meet the Requirement