Rush, Carter Lead Successful Effort to Ensure Pathologists are Able to Address Critical Testing Needs During Pandemic

Mar 26, 2020
Press Release

WASHINGTON — Following a request led by U.S. Representatives Bobby L. Rush (D-Ill.) and Earl L. “Buddy” Carter (R-Ga.), the Centers for Medicare and Medicaid Services (CMS) today announced that it would allow pathologists to perform their important testing capabilities remotely to help address the coronavirus pandemic.

Specifically, Reps. Rush and Carter called on the agency to temporarily waive Clinical Laboratory Improvement Amendments of 1988 (CLIA) requirements regarding working remotely and to allow local pathologists and laboratories to determine what is best for their situation.  On March 26, 2020, the Centers for Medicare and Medicaid Services (CMS) announced that it would allow pathologists to review slides remotely given that certain criteria is met.

“Almost all pathologists have the infrastructure to sign-out cases from remote facilities but do not currently because of requirements under CLIA.  This presents a unique problem for pathologists who are either currently under quarantine or who must remain home to supervise their children due to coronavirus related school closures,” said Rep. Rush.  “As such, I am pleased that HHS has agreed to allow local labs to have flexibility to work remotely.  This will increase capacity, while also protecting the health of staff and ensuring that remaining pathologists are not overburdened with excess work due to staffing shortages.”

“Pathologists are a critical component in our medical system,” said Rep. Carter. “These health care professionals are integral in the testing and diagnosis of patients, and their services are needed now more than ever. As the American health care system continues to face the heavy weight of the coronavirus, it is common sense to allow pathologists to perform their job no matter where they are.”

Typically, it takes several months for pathologists to obtain home CLIA certification. A CLIA waiver is also necessary.  To increase lab space for COVID-19 testing, and to avoid unnecessary exposure to infected patients, pathologists are seeking CLIA certification exemptions to review slides from home.

Today, following a request from Reps. Rush, Carter, and a group of bipartisan members, CMS released guidance announcing they would practice enforcement discretion — allowing pathologists to work from home without a CLIA certification during the pandemic, given that certain criteria is met.

A copy of the letter can be found here, and the agency guidance can be found here.

The following members also signed onto the letter:

Cindy Axne (D-Iowa)

Troy Balderson (R-Ohio)

Ami Bera, M.D. (D-Calif.)

Gus M. Bilirakis (R-Fla.)

Susan Brooks (R-Ind.)

Larry Bucshon (R-Ind.)

Tony Cárdenas (D-Calif.)

André Carson (D-Ind.)

Emanuel Cleaver (D-Mo.)

Diana DeGette (D-Colo.)

Val B. Demings (D-Fla.)

Lloyd Doggett (D-Texas)

Neal P. Dunn, M.D. (R-Fla.)

Brian Fitzpatrick (R-Pa.)

Ruben Gallego (D-Ariz.)

Jesús “Chuy” García (D-Ill.)

H. Morgan Griffith (R-Va.)

Raúl M. Grijalva (D-Ariz.)

Jody Hice (R-Ga.)

Will Hurd (R-Texas)

John B. Larson (D-Conn.)

Stephen F. Lynch (D-Mass.)

Sean Patrick Maloney (D-N.Y.)

Roger Marshall, M.D. (R-Kan.)

James P. McGovern (D-Mass.)

David B. McKinley, P.E. (R-W. Va.)

Scott Peters (D-Calif.)

David E. Price (D-N.C.)

John H. Rutherford (R-Fla.)

Terri Sewell (D-Ala.)

Donna E. Shalala (D-Fla.)

Albio Sires (D-N.J.)

Bryan Steil (R-Wis.)

Steve Stivers (R-Ohio)

Fred Upton (R-Mich.)