Latest NewsCOLA comments on new Clinical Laboratory Fee Schedule

COLA, a physician-directed, non-profit laboratory accrediting organization, recently pointed to their study data showing the importance of near patient testing to the elderly and medically frail and calls upon the Centers for Medicare and Medicaid Services (CMS) and Congress to consider how the anticipated steep cuts from the new Clinical Laboratory Fee Schedule will harm access to critical, rapid, life-saving clinical laboratory testing for Medicare beneficiaries, especially in rural communities.

COLA’s research shows that patients in rural communities will be particularly impacted.  Physicians who participated in the 2017 study reported that their laboratory had saved lives. If they had waited for the tests to return from the nearest laboratory 80-100 miles away, the patient would have died.

“Near patient testing is invaluable to early diagnosis and treatment and it can prevent patients from ending up in more expensive treatment settings,” according to Dr. John Daly, Chief Medical Officer of COLA. “Access to laboratory testing in rural communities will be devastated if these cuts proceed.”

On Friday, September 22, 2017, CMS released the 2018 Clinical Laboratory Fee Schedule as required under the Protecting Access to Medicare Act (PAMA) of 2014. PAMA directed CMS to gather data from labs on what private insurers reimburse for clinical laboratory testing. CMS is using payment data submitted by certain laboratories to establish what Medicare will pay for lab tests. Unfortunately, experts report that the complex implementation of the law has led to inaccuracies and incomplete laboratory payment data resulting in a pricing schedule that does not reflect the market.

The proposed CMS reimbursement cuts for lab tests, which are commonly performed in patient care settings including physician offices, nursing homes, rehabilitation centers and urgent care centers, will impose burdens on the frailest Medicare beneficiaries and will harm patient care. Near patient testing offers many benefits, including rapid, accurate results in the treatment of diabetes; same day laboratory information for oncologists to treat their patients undergoing chemotherapy; and the quick detection of infectious diseases.

COLA’s preliminary data from the evaluative study is published on

Comments are due to CMS on the Clinical Laboratory Fee Schedule October 23, 2017.

About Dr. John Daly

John T. Daly, M.D. has served as COLA’s Chief Medical Officer since 2011, where he provides professional medical knowledge and experience to represent the clinical voice in the implementation of COLA policy. His responsibilities include taking a proactive approach to the development and implementation of COLA policy in a rapidly evolving healthcare environment, with maintaining a continuing emphasis on quality laboratory medicine and patient safety.

Dr. Daly previously practiced clinical pathology in both the community and academic settings until his retirement from Duke Medicine in 2009.  Dr. Daly earned his M.D. degree at Cornell University Medical College in New York City, and performed his internship and residency in pathology at Duke University Medical Center.  He is certified by the American Board of Pathology in Anatomic, Clinical and Forensic Pathology and is a member of the American Association for Clinical Chemistry, the College of American Pathologists and the American Society for Clinical Pathology.

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