Cost Analysis & Reimbursement

In the modern healthcare environment, the laboratory is simultaneously a clinical powerhouse and a financial business unit. To ensure the laboratory remains viable, the laboratory scientist and administration must understand exactly how much it costs to generate a test result and how the healthcare system reimburses for that work. This balance determines whether the laboratory generates a profit (margin) or operates at a loss. Mastery of these concepts is essential for pricing strategies, contract negotiations, and the decision-making process regarding whether to perform testing in-house or send it to a reference laboratory

Cost Analysis: Determining the Cost Per Test

Cost analysis is the accounting process of defining the actual expense incurred by the laboratory to produce a single reportable result (e.g., one CBC). This is distinct from the “Price” or “Charge” (what the lab bills the patient). A precise understanding of the cost per test allows the lab to set charges that cover expenses and generate a margin

Classification of Costs

To calculate the cost of a test, expenses must be broken down by their behavior relative to testing volume

  • Fixed Costs: These expenses remain constant regardless of the volume of testing performed. Whether the lab runs 1 sample or 1,000 samples, these bills must be paid
    • Examples: Instrument lease/rental fees, Laboratory Information System (LIS) maintenance fees, management salaries, accreditation fees (CAP/CLIA), and facility overhead (rent, electricity)
  • Variable Costs: These expenses fluctuate in direct proportion to the volume of testing. If zero tests are performed, these costs are zero
    • Examples: Reagents (lyse, diluent), consumables (pipette tips, sample tubes, glass slides), and biomedical waste disposal fees
  • Semi-Variable (Stepped) Costs: These costs remain fixed over a certain range of volume but jump to a new level when volume increases significantly
    • Example: Staffing. A lab needs a minimum staff to open the doors. However, if volume doubles, the lab must hire an additional laboratory scientist or pay overtime, causing a “step up” in cost

Components of the Cost Per Test

The formula for the cost of a single test combines three distinct elements:

  1. Direct Materials: The sum of all reagents, controls, calibrators, and disposables used for that specific test. This also accounts for “dead volume” (wasted reagent) and repeat testing
  2. Direct Labor: Calculated by measuring the “hands-on” time required by the laboratory scientist to receive, process, analyze, and verify the specimen, multiplied by the average hourly wage (plus benefits)
  3. Indirect Costs (Overhead): A calculated allocation of the hospital’s general operating expenses. This includes the lab’s share of Human Resources, Purchasing, Janitorial services, and building depreciation. This is often applied as a percentage surcharge to the direct costs

Break-Even Analysis

Break-even analysis is a financial calculation used to determine the volume of testing required to cover all costs. It is the tipping point where the laboratory stops losing money and starts making a profit. This is the primary tool used for “Make vs. Buy” decisions (deciding whether to perform a test in-house or send it to a reference lab)

  • The Formula: \(\text{Break-Even Volume} = \frac{\text{Total Fixed Costs}}{\text{Revenue per Test} - \text{Variable Cost per Test}}\)
  • Contribution Margin: The denominator (Revenue minus Variable Cost) is known as the Contribution Margin. It represents the amount of money from each test available to pay down the Fixed Costs
  • Clinical Application: If a Hematology lab is considering bringing a molecular Factor V Leiden test in-house, they calculate the Break-Even point. If the break-even volume is 50 tests/month, but the lab only sees 10 patients/month, the analysis suggests it is financially sounder to continue sending the test out, regardless of the clinical desire to have it in-house

Reimbursement Coding: The Language of Payment

Laboratories do not bill for “a white count”; they bill for specific alpha-numeric codes defined by regulatory bodies. If the coding is incorrect, the claim is denied, and the laboratory receives zero revenue

  • CPT Codes (Current Procedural Terminology): Developed by the AMA, these 5-digit codes describe what medical service was performed
    • Example: 85025: is the CPT code for a Complete Blood Count (CBC) with Automated Differential
    • Example: 85027: is the CPT code for a CBC without differential
  • ICD-10 Codes (International Classification of Diseases): These codes describe the patient’s diagnosis or symptoms - the why the test was performed
    • Medical Necessity: Payers (insurance) will only reimburse if the ICD-10 code justifies the CPT code. For example, Medicare will pay for a Ferritin level (CPT 82728) if the diagnosis is Anemia (ICD-10 D64.9), but they may deny payment if the diagnosis is “Ingrown Toenail”
  • HCPCS Codes (Healthcare Common Procedure Coding System): While Level I HCPCS are identical to CPT, Level II codes cover products, supplies, and services not included in CPT (often relevant for blood products in Transfusion Medicine)

Reimbursement Models

How the laboratory gets paid depends heavily on the patient’s status (Inpatient vs. Outpatient) and the payer (Government vs. Private). The shift from “Fee-for-Service” to “Value-Based Care” significantly impacts laboratory economics

Inpatient Reimbursement (DRG)

Medicare and many private insurers pay for inpatient hospital stays using the Diagnosis Related Group (DRG) system

  • The Bundle: Under DRG, the hospital receives a single lump-sum payment based on the patient’s discharge diagnosis (e.g., “Pneumonia”). This payment covers the room, nursing, pharmacy, and Laboratory
  • Cost Center Dynamic: Because the payment is fixed, performing more lab tests does not generate more revenue. Instead, every test performed subtracts from the hospital’s profit margin for that patient. Consequently, for inpatients, the lab acts as a Cost Center, and the administrative goal is Utilization Management (reducing unnecessary testing)

Outpatient Reimbursement (Fee Schedule/APC)

For outpatients (clinic visits, ER), reimbursement is typically based on a Fee Schedule or Ambulatory Payment Classification (APC)

  • Fee-for-Service: In this model, the laboratory is paid a specific amount for each individual CPT code performed
  • Revenue Center Dynamic: Because every test generates a specific payment, performing more tests generally increases revenue. Here, the lab acts as a Revenue Center
  • Clinical Laboratory Fee Schedule (CLFS): Medicare sets a national limit on the amount they will pay for every lab test. Private insurance companies often peg their reimbursement rates to a percentage of the Medicare CLFS

Capitation

Common in HMOs, this model pays the provider a fixed amount Per Member Per Month (PMPM) regardless of how many services the patient uses. The provider assumes the financial risk. If the laboratory runs too many tests on these patients, the provider loses money

Compliance & Revenue Integrity

To prevent fraud and abuse, strict regulations govern how laboratories bill for services

  • Unbundling: It is illegal to use multiple CPT codes for the components of a test that has a single comprehensive code
    • Example: A lab performs a CBC (85025). They cannot bill separately for the RBC count, WBC count, and Platelet count to increase revenue. The NCCI (National Correct Coding Initiative) edits automatically reject these “unbundled” claims
  • Advance Beneficiary Notice (ABN): If a lab believes Medicare will deny payment for a test because it lacks “Medical Necessity” (the diagnosis code doesn’t match the test), they must present an ABN to the patient before collection. The ABN notifies the patient that they may be personally responsible for the cost. If the lab fails to get a signed ABN and Medicare denies the claim, the lab cannot bill the patient and must absorb the loss