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Clinical Laboratory Fee Schedule
Outpatient clinical laboratory services are paid based on the Medicare Part B Clinical Laboratory Fee Schedule (CLFS) in accordance with Section 1833(h) of the Social Security Act. Payment is the lesser of the amount billed, the local fee for a geographic area, or a national limit. In accordance with the statute, the national limits are set at a percent of the median of all local fee schedule amounts for each laboratory test code. Each year, fees are updated for inflation based on the percentage change in the Consumer Price Index. However, legislation by Congress can modify the update to the fees.
Co-payments and deductibles do not apply to services paid under the Medicare clinical laboratory fee schedule.
Each year, new laboratory test codes are added to the clinical laboratory fee schedule and corresponding fees are developed in response to a public comment process. Also, for a cervical or vaginal smear test (Pap smear), the fee cannot be less than a national minimum payment amount, initially established at $14.60 and updated each year for inflation.
Critical access hospitals are paid for outpatient laboratory services on a reasonable cost basis, instead of by the fee schedule. Hospitals with fewer than 50 beds in qualified rural areas—those with population densities in the lowest quartile of all rural areas—are paid based on a reasonable cost basis for outpatient clinical laboratory tests for cost reporting periods between July 2004 and July 2006.
The Protecting Access to Medicare Act of 2014 (PAMA) that became law on April 1, 2014, required labs to report such data and the test volumes associated with that data, beginning on Jan. 1, 2016.
On Jan. 1, 2017, CMS will use the market data to set prices for the Part B Clinical Laboratory Fee Schedule. As currently written, PAMA specifies that CMS cannot cut the price of a specific lab test by more than 10% in each of 2017, 2018, and 2019, nor by more than 15% in each of 2020, 2021, and 2022. There is no limit on price reductions outlined in the law for years following 2022.
Coverage, Reimbursement Still Difficult for New Lab Tests
By Robert Michel | From the Volume XXIX, No. 11 – August 8, 2022 Issue
CEO SUMMARY: Bringing a new proprietary diagnostic test to market is an arduous process. It takes patience and planning to complete the journey from test development to payer reimbursement. This slow process stems from the fact that the healthcare reimbursement system is fragmented,…
Labcorp to Buy Outreach, Manage Ascension Labs
By Robert Michel | From the Volume XXIX, No. 3 – February 22, 2022 Issue
CEO SUMMARY: In a blockbuster deal valued at almost half a billion dollars, Labcorp will manage dozens of hospital labs in 10 states on behalf of Ascension Health, one of the biggest health systems in the country. Labcorp will also spend $400 million to acquire certain assets of Asc…
Non-COVID Part B Lab Spend Declined by 15.9% in 2020
By Robert Michel | From the Volume XXIX, No. 2 – January 31, 2022 Issue
MEDICARE PART B CLINICAL LABORATORY FEE SCHEDULE CUTS mandated by PAMA continue to bite deeply. A new government report shows that during fiscal 2020, the Medicare program spent 15.9% less for lab tests, when COVID-19 test payments are excluded. The fed…
Congress Votes: No PAMA Price Cuts for 2022
By R. Lewis Dark | From the Volume XXVIII, No. 17 – December 20, 2021 Issue
IT’S WELCOME NEWS THAT CONGRESS VOTED EARLIER THIS MONTH to defer the PAMA price cuts to the Clinical Laboratory Fee Schedule (CLFS) that were scheduled to take place in 2022. This is a positive development for the finances of the nation’s clinical labs, particularly the smaller, independent labs t…
CMS Publishes Proposed 2021 Medicare Physician Fee Schedule
By Robert Michel | From the Volume XXVII, No. 12 – August 24, 2020 Issue
MEDICARE’S PROPOSED PHYSICIAN FEE SCHEDULE (PFS) rule was announced on Aug. 4, 2020. The rule had one positive development for clinical laboratories and hospital laboratory outreach programs and a negative development for anatomic pathologists. Clinical laboratories and hospital outreach lab…
Lab, Path Finances Crash; Next Test Wave: Serology
By Robert Michel | From the Volume XXVII No. 6 – April 20, 2020 Issue
CEO SUMMARY: For clinical laboratories and anatomic pathology groups, the day-by-day impact of the COVID-19 pandemic is unfolding much like Hurricane Katrina hitting New Orleans in 2005. Every 24 hours, labs get unwelcome news, along with uncertainty about whether it will …
January 6, 2020 Intelligence: Late Breaking Lab News
On Dec. 19, Congress passed a year-end spending bill that included the Laboratory Access for Beneficiaries (LAB) Act. The bill went to the President for his signature. The bill mandates that the federal Centers or Medicare and Medicaid Services (CMS) delay by one year having labs rep…
Lawsuits Alleging Overcharges to Proceed in Two Courts in 2020
By Joseph Burns
CEO SUMMARY: Two lawsuits filed in federal courts against Laboratory Corporation of America and Quest Diagnostics may have consequences for the entire lab industry. The plaintiffs are patients who allege that the two defendant lab companies charged them as much as 10 times more than what …
2019’s Top 10 Lab Stories Reveal Major Laboratory Industry Trends
This is an excerpt of a 3,163-word article in the Dec. 16, 2019 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: There was plenty of bad news in 2019 for clinical labs and pathology groups. Yet lurking inside this new…
In New Mexico, Three Collaborators Improve Patient Care, Outcomes
By Joseph Burns | From the Volume XXVI No. 11 – August 12, 2019 Issue
IT’S OFFICIAL! A YEAR-LONG COLLABORATION involving a health insurer, a clinical laboratory, and an analytics company showed that insurers and physicians can use clinically-actionable intelligence developed from medical lab test data to improve patient outcomes. This important accomplishment in patie…
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Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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