Georgia Medicare Clinical Laboratory Services Benefit

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By Brevy Care Team · Last verified May 13, 2026

Section 1861(s)(3) of the Social Security Act, codified at 42 U.S.C. 1395x(s)(3), establishes diagnostic laboratory tests as a Medicare Part B benefit. Section 1833(h) governs payment under the Clinical Laboratory Fee Schedule (CLFS), the national fee schedule that has paid clinical diagnostic laboratory tests since its inception. Section 1834A, added by the Protecting Access to Medicare Act of 2014, fundamentally restructured CLFS payment by requiring "applicable laboratories" to report private payer rate and volume data so that CMS could calculate market-based rates derived from a weighted median of those rates. The regulatory framework at 42 CFR Part 414 Subpart G implements the CLFS, and 42 CFR Part 493 implements the Clinical Laboratory Improvement Amendments of 1988 (CLIA), the federal quality and personnel standards that govern every laboratory testing human specimens for health assessment in the United States.

For Georgia Medicare beneficiaries undergoing annual blood work at a Quest Diagnostics or LabCorp patient service center, receiving anatomic pathology at Emory University Hospital after a biopsy, awaiting tumor genomic testing through Foundation Medicine after a colorectal cancer diagnosis at Augusta University Medical Center, completing a screening mammogram at Piedmont Atlanta, or receiving homebound specimen collection in Athens for chronic Coumadin monitoring, the clinical laboratory services benefit determines what tests Medicare will pay for, what frequency rules apply to preventive screening tests, what cost-sharing applies (typically zero for CLFS tests under the long-standing Section 1833(a)(1)(D)(i) exemption), and what to do when claims are denied for medical necessity or frequency reasons.

This guide explains every component of the Medicare clinical laboratory services benefit as it applies in Georgia: the statutory framework under Sections 1861(s)(3) and 1833(h), the PAMA 2014 market-based reform under Section 1834A, the CLIA 1988 regulatory framework including the three CLIA certificate types and the moderate-complexity and high-complexity personnel standards, the National Coverage Determinations for laboratory tests, the Local Coverage Determinations issued by Palmetto GBA Jurisdiction J for Georgia, the Independent Diagnostic Testing Facility standards under 42 CFR 410.33, the screening laboratory tests with statutory frequency limits (Section 1861(nn) pap smear, Section 1834(c) screening mammography, Section 1834(g) colorectal cancer screening), the specimen collection fees, the role of Palmetto GBA as the Medicare Administrative Contractor for Georgia Part B claims, and the Georgia laboratory landscape from hospital central laboratories to national chains to physician office laboratories. Six worked examples illustrate real Georgia beneficiary scenarios from annual blood work in Atlanta to homebound monitoring in Athens, and a 25-question accordion FAQ closes the remaining gaps. :::

::: callout Key Takeaways: Medicare Clinical Laboratory Services Benefit in Georgia

1. Section 1861(s)(3) SSA establishes diagnostic laboratory tests as a Part B benefit. Section 1833(h) establishes the Clinical Laboratory Fee Schedule.
2. Section 1833(a)(1)(D)(i) exempts CLFS tests from cost-sharing: no Part B deductible, no 20 percent coinsurance. This is one of the most significant cost-sharing exemptions in Medicare Part B and applies to the vast majority of clinical laboratory tests.
3. Section 1834A, added by PAMA 2014, fundamentally restructured CLFS payment. "Applicable laboratories" report private payer rate and volume data; CMS calculates weighted median market rates that become the new CLFS rates.
4. CLIA 1988 (Public Law 100-578) establishes federal quality standards for all laboratories testing human specimens. Three certificate types: Certificate of Waiver, Provider-Performed Microscopy, and Certificate of Compliance or Certificate of Accreditation. Personnel and quality standards vary by test complexity.
5. National Coverage Determinations govern specific laboratory tests including PSA screening tests, thyroid testing, lipid testing, and others. LCDs issued by Palmetto GBA Jurisdiction J apply in Georgia.
6. Statutory frequency limits for screening laboratory tests: pap smear and pelvic exam under Section 1861(nn); screening mammography under Section 1834(c); colorectal cancer screening per Section 1834(g) options. Consult current Medicare guidelines for applicable frequency rules.
7. Palmetto GBA Jurisdiction J is the Medicare Administrative Contractor for Part B claims in Georgia, Alabama, and Tennessee. Palmetto processes Georgia laboratory claims, issues LCDs, and handles initial appeals.
8. Georgia laboratory landscape: hospital central laboratories (Emory, Piedmont, Wellstar, NGHS, Memorial Health, AU Health, Atrium Navicent, Phoebe Putney, Grady), national chains (LabCorp, Quest Diagnostics, BioReference), and physician office laboratories with CLIA Certificates of Waiver or Provider-Performed Microscopy. :::

Federal Statutory and Regulatory Authority for the Medicare Clinical Laboratory Services Benefit

The Medicare clinical laboratory services benefit rests on multiple layers of statutory and regulatory authority that have accumulated since the original Medicare statute in 1965. Understanding these layers is essential because laboratory coverage disputes are common, particularly for tests not specifically addressed by National Coverage Determinations and for tests whose coverage depends on specific diagnostic indications.

Section 1861(s)(3) of the Social Security Act, codified at 42 U.S.C. 1395x(s)(3), is the foundational provision establishing diagnostic laboratory tests as a Part B benefit. The provision covers tests furnished by independent laboratories, hospital outpatient laboratories, and physician office laboratories. Coverage is limited to tests that meet the Section 1862(a)(1)(A) reasonable-and-necessary standard plus any applicable National or Local Coverage Determination requirements.

Section 1833(h) of the Social Security Act, codified at 42 U.S.C. 1395l(h), establishes the Clinical Laboratory Fee Schedule. The CLFS was originally enacted by the Deficit Reduction Act of 1984. The original CLFS replaced the prior reasonable-charge methodology with a regional fee schedule, later consolidated to a single national fee schedule. The CLFS has historically been used for "clinical diagnostic laboratory tests" (CDLTs), generally those defined as automated multichannel chemistry panels, hematology, microbiology, immunology, urinalysis, and other tests that do not require the professional services of a pathologist for interpretation.

Critically, Section 1833(a)(1)(D)(i) exempts CLFS tests from the Part B deductible and the 20 percent coinsurance. This is one of the most significant cost-sharing exemptions in the Medicare Part B benefit structure and reflects the long-standing congressional policy of encouraging both diagnostic and preventive laboratory testing.

Section 1834A of the Social Security Act, codified at 42 U.S.C. 1395m-1, is the PAMA 2014 reform that fundamentally restructured CLFS payment. Added by the Protecting Access to Medicare Act of 2014, Section 1834A requires "applicable laboratories" to report private payer rate and volume data for each CLFS HCPCS code, and authorizes CMS to calculate a weighted median of those rates that becomes the new CLFS rate.

Key Section 1834A provisions:

• Definition of "applicable laboratory" at 42 CFR 414.502: a laboratory meeting specified revenue threshold criteria from CLFS or PFS combined, with a minimum CLFS revenue floor, from a data collection period.
• Definition of "applicable information": each private payer rate paid by each private payer for each HCPCS code, and the corresponding volume.
• Payment limit phase-in: annual payment reduction caps apply to prevent abrupt rate disruption (subject to multiple statutory delays).
• Advanced Diagnostic Laboratory Test (ADLT) pathway: separate pricing methodology for novel single-source tests including initial pricing at the laboratory's list price for three quarters, then transition to CLFS market rates.

Section 1861(nn) establishes screening pap smear and screening pelvic examination as covered Part B preventive services. Section 1834(c) establishes screening mammography with statutory frequency limits. Section 1834(g) establishes colorectal cancer screening.

Section 1862(a)(1)(A) of the Social Security Act is the reasonable-and-necessary standard. Even when a laboratory test is technically within the CLFS, Medicare will not pay unless the test was reasonable and necessary for the patient's diagnosis or treatment.

Section 1869(f) of the Social Security Act establishes the framework for National Coverage Determinations and Local Coverage Determinations. NCDs are issued by CMS and apply nationally; LCDs are issued by Medicare Administrative Contractors and apply only within the MAC's jurisdiction.

42 CFR 410.32 establishes that diagnostic tests must be ordered by the treating physician for the purpose of diagnosing or treating an illness or injury. The "treating physician" requirement is the regulatory mechanism that prevents standing orders, mass screening orders unrelated to clinical care, and similar improper uses.

42 CFR 410.33 establishes the Independent Diagnostic Testing Facility (IDTF) framework, with 14 IDTF performance standards governing operational capability, licensure compliance, physical site requirements, medical record maintenance, HIPAA compliance, and other operational and quality standards.

42 CFR Part 414, Subpart G implements the CLFS payment methodology, including the rate-setting under Section 1834A, the data reporting requirements, and the new-test pricing pathway.

42 CFR Part 493 implements the Clinical Laboratory Improvement Amendments of 1988, establishing the three CLIA certificate types, personnel standards by test complexity, quality control requirements, proficiency testing, and survey and enforcement procedures.

Statutory history: Clinical laboratory services have been a Part B benefit from Medicare's inception under Section 1861(s)(3). Pre-CLFS payment was under reasonable-charge methodology. The Deficit Reduction Act of 1984 established the CLFS. The Clinical Laboratory Improvement Amendments of 1988 (Public Law 100-578) established CLIA. The Omnibus Budget Reconciliation Act of 1989 (Public Law 101-239) consolidated the CLFS to a single national fee schedule. The Balanced Budget Act of 1997 (Public Law 105-33) imposed payment freezes. The Medicare Modernization Act of 2003 (Public Law 108-173) established the Welcome to Medicare Physical Examination and expanded preventive services. The Affordable Care Act of 2010 (Public Law 111-148) in Section 4103 established the Annual Wellness Visit and in Section 4104 removed cost-sharing for grade A and B preventive services. The Protecting Access to Medicare Act of 2014 fundamentally restructured CLFS payment via Section 1834A. The CARES Act of 2020 (Public Law 116-136) in Section 6001 required Medicare coverage of COVID-19 testing with no cost-sharing.

The Clinical Laboratory Fee Schedule and PAMA 2014 Market-Based Reform

The Clinical Laboratory Fee Schedule pays for clinical diagnostic laboratory tests (CDLTs) furnished to Medicare beneficiaries. CDLTs include automated chemistry panels, hematology, microbiology, immunology, urinalysis, molecular pathology, and similar tests that generally do not require the professional services of a pathologist for interpretation. Anatomic pathology services (such as biopsy interpretation, cytology slide review, and immunohistochemistry interpretation) are paid under the Medicare Physician Fee Schedule rather than the CLFS.

Pre-2018 CLFS methodology

From 1984 through 2017, the CLFS operated on a national fee schedule with annual updates based on the Consumer Price Index for All Urban Consumers (CPI-U) or, in some years, frozen or reduced by congressional action. The base rates were essentially set in 1984 with adjustments over subsequent decades. By the early 2010s, multiple studies found that Medicare CLFS rates substantially exceeded the rates paid by private commercial insurers for the same tests.

PAMA 2014 Section 216 reform

The Protecting Access to Medicare Act of 2014 ordered fundamental reform. The statute added Section 1834A to the Social Security Act, establishing a market-based payment methodology.

The mechanism works as follows:

1. Applicable laboratories (defined as laboratories meeting defined CLFS/PFS revenue thresholds) collect data on private payer rates and volumes for each CLFS HCPCS code during a six-month Data Collection Period (DCP).
2. Applicable laboratories report this "applicable information" to CMS during a Data Reporting Period (DRP).
3. CMS calculates a weighted median of the private payer rates for each HCPCS code.
4. The weighted median becomes the new CLFS rate for that code.
5. To prevent abrupt rate disruption, payment reductions are capped by statute per applicable year (subject to statutory delays).

Reporting delays and methodology challenges

The PAMA reform has experienced multiple delays and methodological challenges. The initial reporting period was followed by subsequent reporting periods that were repeatedly postponed by the Further Consolidated Appropriations Act of 2020, the CARES Act of 2020, the Consolidated Appropriations Act of 2021, and subsequent appropriations and continuing resolutions. As of recent statutory action, the next data reporting period remains delayed to permit CMS and Congress to revisit the methodology, particularly with respect to definitional issues around "applicable laboratory" (hospital outreach laboratories were largely excluded from reporting under the original implementation, leading to questions about representativeness).

Advanced Diagnostic Laboratory Tests (ADLTs)

Section 1834A established a separate pricing pathway for Advanced Diagnostic Laboratory Tests, defined as clinical diagnostic laboratory tests that are:

• Offered and furnished only by a single laboratory
• Covered under Medicare
• Either molecular pathology analyses of multiple biomarkers, OR otherwise novel and unique tests cleared or approved by the FDA

For an ADLT, the initial three quarters of pricing are at the laboratory's list price, after which the test transitions to CLFS market-based rates derived from private payer reporting. ADLT status must be requested by the laboratory and approved by CMS.

Cost-sharing exemption

The PAMA reform did not change the long-standing CLFS cost-sharing exemption under Section 1833(a)(1)(D)(i). Beneficiaries continue to owe $0 for clinical laboratory tests paid under the CLFS: no Part B deductible, no coinsurance. This is the single most important cost-sharing rule in the Medicare laboratory benefit.

CLIA 1988: Federal Quality Standards for All Clinical Laboratories

The Clinical Laboratory Improvement Amendments of 1988 (Public Law 100-578), codified principally at 42 U.S.C. 263a (Section 353 of the Public Health Service Act), established federal quality and personnel standards for all laboratories testing human specimens for health assessment, diagnosis, prevention, or treatment. Implementation is at 42 CFR Part 493.

CLIA applies to virtually every clinical laboratory in the United States, from large national reference laboratories to hospital central laboratories to physician office laboratories. A laboratory cannot legally test human specimens for clinical purposes (and cannot bill Medicare for such testing) without an appropriate CLIA certificate.

Three CLIA certificate types

1. Certificate of Waiver: For laboratories performing only "waived" tests. Waived tests are FDA-categorized as simple tests with insignificant risk of erroneous result, such that the laboratory may perform them following the manufacturer's instructions without personnel qualifications or quality control beyond manufacturer guidance. Common waived tests:

• Urine dipstick (chemistry and microscopy modes)
• Fingerstick blood glucose
• Rapid strep test (Group A Streptococcus)
• Rapid influenza A/B test
• Fecal occult blood test (immunochemical and guaiac)
• Pregnancy test (urine HCG)
• Hemoglobin A1c (selected FDA-cleared waived devices)
• INR (prothrombin time, selected FDA-cleared waived devices)
• Strep group A direct
• BNP (selected waived devices)

A Certificate of Waiver is the simplest CLIA certificate, with an annual fee and no personnel standards beyond following manufacturer instructions. Waived-certificate laboratories are subject to limited oversight (typically random sample CLIA inspections).

2. Provider-Performed Microscopy (PPM): For physicians (or PAs, NPs, CNSs with appropriate credentialing) who personally perform certain direct microscopy tests during a patient encounter. Common PPM tests:

• Wet mount preparations (vaginal, urine)
• KOH preparations
• Pinworm examinations
• Urine sediment examinations
• Fecal leukocytes
• Fern test
• Qualitative semen analysis (presence/absence of sperm)

PPM certification requires the practitioner to personally perform the test (not delegated to a technician) at the point of care.

3. Certificate of Compliance (CoC) or Certificate of Accreditation (CoA): For laboratories performing moderate-complexity, high-complexity, or PPM tests. CoC laboratories are surveyed by CMS or the state survey agency. CoA laboratories are surveyed by CMS-deemed Accreditation Organizations, including:

• College of American Pathologists (CAP): the most common AO for hospital and reference laboratories
• The Joint Commission (TJC)
• COLA: common for physician office laboratories and small independent laboratories
• American Association of Blood Banks (AABB): for blood banks and transfusion services
• American Society for Histocompatibility and Immunogenetics (ASHI): for histocompatibility laboratories

Personnel standards by test complexity

CLIA categorizes tests as waived, moderate-complexity, or high-complexity based on FDA categorization. Personnel standards scale with complexity:

• Moderate-complexity testing: laboratory director must have qualified credentials (MD/DO, doctoral-level scientist, or specified bachelor's-degree-plus-experience pathways). Testing personnel must have at least an associate degree in laboratory science or equivalent training. Technical consultant and clinical consultant required.
• High-complexity testing: laboratory director must be a board-certified pathologist or doctoral-level scientist with specified credentials. Technical supervisor required for each specialty. Clinical consultant required. Testing personnel must meet specific education and training standards.

Quality control and proficiency testing

• Quality control requirements vary by test specialty and complexity
• Daily quality control documentation required for most tests
• Proficiency testing: three times per year for most regulated analytes
• Laboratories receive samples from approved proficiency testing providers, test them as patient samples, and submit results
• Failure to pass proficiency testing triggers enforcement actions: directed plan of correction, suspension of testing in the specialty, certificate revocation in extreme cases

Survey and enforcement

CLIA inspections occur biennially (every two years). Inspectors review records, observe testing procedures, interview personnel, and identify deficiencies. Deficiencies are classified by severity:

• Standard-level deficiencies: corrected through plan of correction
• Condition-level deficiencies: more serious; may require directed plan of correction
• Immediate jeopardy: severe deficiencies posing immediate risk to patient health; may result in suspension or revocation

Enforcement actions can include civil monetary penalties, certificate suspension, certificate revocation, and (in cases of willful misrepresentation or fraud) criminal prosecution.

National Coverage Determinations for Laboratory Tests

National Coverage Determinations specifically address laboratory tests, establishing covered indications, frequency limits, and diagnostic-code requirements. Some of the most important NCDs include:

• Prostate-Specific Antigen (PSA): covers PSA testing for the diagnosis of prostate cancer and for monitoring of patients with diagnosed prostate cancer, with specified diagnostic indications.
• Prostate Cancer Screening Tests: covers screening PSA testing annually for men age 50 and older, with no cost-sharing.
• Thyroid Testing: covers TSH, free T4, free T3, T3 uptake, total T4, total T3 for specific clinical indications including suspected hyperthyroidism, hypothyroidism, monitoring of thyroid replacement therapy, and others.
• Lipid Testing: covers lipid panel components (total cholesterol, HDL, LDL, triglycerides) for evaluation of suspected lipid disorders, monitoring of established disorders, and cardiovascular risk assessment.
• Glycated Hemoglobin/Glycated Protein: covers hemoglobin A1c for diabetes diagnosis and monitoring.
• Blood Counts: covers complete blood count for specific clinical indications.
• Human Immunodeficiency Virus (HIV): covers HIV testing for diagnosis and monitoring of suspected or diagnosed HIV infection.
• Hepatitis Panel: covers hepatitis testing panels for specific clinical indications.
• Tumor Antigens (CA 125, CA 15-3/27-29, CA 19-9): cover tumor markers for specific oncologic indications.

Each NCD typically lists covered diagnosis codes (ICD-10) that establish medical necessity. Laboratories and ordering providers must ensure that claims include a covered diagnosis code to avoid denials.

Local Coverage Determinations Issued by Palmetto GBA for Georgia

Palmetto GBA Jurisdiction J issues Local Coverage Determinations applicable in Georgia, Alabama, and Tennessee. LCDs cover laboratory tests not specifically addressed by national NCDs. Examples include:

• Molecular pathology procedures (various)
• Drug testing panels
• Allergy testing
• Vitamin D testing
• Various tumor genetic tests
• Genetic testing for hereditary cancer syndromes

LCDs include covered indications, non-covered indications, ICD-10 diagnostic-code requirements, and documentation requirements. Suppliers and providers should consult the current Palmetto GBA LCD database before billing.

Screening Laboratory Tests and Statutory Frequency Limits

Several preventive laboratory tests have specific statutory frequency limits and are exempt from cost-sharing under the ACA 2010 Section 4104 expanded preventive services provisions.

Screening pap smear and screening pelvic exam (Section 1861(nn))

• Covered periodically for women not at high risk for cervical or vaginal cancer (see current Medicare guidelines for applicable frequency)
• Covered more frequently for women at high risk (specified clinical history including DES exposure, abnormal pap history, immunocompromised status, or other defined high-risk factors)
• HCPCS Q0091 for obtaining the screening pap specimen; HCPCS 88142 (or related codes) for the pap test itself
• $0 cost-sharing for preventive screening (Grade A or B USPSTF recommendation)

Screening mammography (Section 1834(c))

• Annual screening mammography for eligible women (see current Medicare guidelines for applicable age requirements)
• One baseline mammogram permitted for eligible women in a specified age range
• HCPCS 77067 (screening mammography, bilateral)
• $0 cost-sharing
• Diagnostic mammography (after abnormal screening result) follows standard Part B cost-sharing in some cases; specific provisions apply

Colorectal cancer screening (Section 1834(g))

Multiple screening modalities available:

• Fecal occult blood test (FOBT) or fecal immunochemical test (FIT): annual, age 50+
• Multi-target stool DNA test (Cologuard): covered periodically for eligible beneficiaries (see current Medicare coverage for frequency and age criteria)
• Flexible sigmoidoscopy: covered at defined intervals
• Screening colonoscopy: covered periodically based on risk level and prior screening history (see current Medicare guidelines for frequency)
• CT colonography: covered for diagnostic purposes; screening coverage varies

The Consolidated Appropriations Act of 2021 phased in reduced coinsurance for screening colonoscopy that becomes diagnostic when a polyp is removed, with coinsurance decreasing over a multi-year phase-in to zero. This provision addressed the long-standing inequity in which a beneficiary scheduled for a screening colonoscopy who had a polyp removed faced standard Part B coinsurance on the procedure converted to diagnostic.

Other preventive screening tests

• Cardiovascular screening blood test (lipid panel): covered periodically for at-risk beneficiaries
• Diabetes screening (Section 1861(yy)): covered for at-risk beneficiaries (multiple tests may be covered per year based on clinical criteria)
• HIV screening: annual for at-risk beneficiaries
• Hepatitis C screening: one-time for at-risk; annual for high-risk
• Bone mass measurement (Section 1861(rr)): covered periodically for at-risk women and certain men

The Independent Diagnostic Testing Facility Framework

The Independent Diagnostic Testing Facility (IDTF) is a separate Medicare provider type established at 42 CFR 410.33. IDTFs are fixed-location, mobile, or individual entities that furnish diagnostic procedures with physician supervision. Common examples include freestanding imaging centers, sleep study laboratories, electrocardiography (EKG) laboratories, and certain mobile diagnostic services.

Fourteen IDTF performance standards (42 CFR 410.33(g))

1. Demonstrate operational capability to furnish all of the services listed on its enrollment application.
2. Comply with applicable Federal and State licensure and regulatory requirements.
3. Provide complete and accurate information on its enrollment application.
4. Maintain a physical site at the location indicated on its enrollment application.
5. Maintain a comprehensive liability insurance policy meeting the minimum coverage requirements established by 42 CFR 410.33(g)(5).
6. Maintain medical records and patient records.
7. Comply with HIPAA privacy and security regulations.
8. Operate in a manner consistent with applicable State licensure requirements.
9. Be open and operating during posted hours.
10. Have one or more supervising physicians.
11. Permit unannounced site visits by CMS or its agents.
12. Provide written notice of changes in IDTF operations or ownership.
13. Maintain Q&A documentation.
14. Other standards as specified.

IDTF supervision levels

Diagnostic tests furnished by IDTFs require physician supervision at one of three levels:

• General supervision: physician must be available by telephone but need not be physically present
• Direct supervision: physician must be present in the office suite and immediately available
• Personal supervision: physician must be in attendance during the procedure

Most diagnostic tests require general supervision. Certain higher-complexity procedures require direct or personal supervision.

Specimen Collection Fees

Medicare pays separately for specimen collection in defined circumstances:

• HCPCS 36415: routine venipuncture, paid under Part B
• HCPCS P9612: collection of capillary blood specimen
• HCPCS G0471: collection of venous blood by venipuncture in SNF or HHA setting
• HCPCS P9603 and P9604: travel allowance for collection from a homebound patient or patient in a SNF (per mile or flat fee)

The travel allowance is particularly important for mobile phlebotomy services serving homebound Medicare beneficiaries in Georgia. LabCorp and Quest both offer mobile phlebotomy in metropolitan Atlanta, Macon, Savannah, Augusta, and other Georgia urban areas. Hospital-affiliated home health programs and certain independent mobile phlebotomy services also serve rural Georgia.

Hospital Outpatient Laboratory: CLFS or OPPS

A common point of confusion is the payment methodology for laboratory tests furnished by hospital outpatient laboratories. The general rules:

• Hospital outpatient laboratory tests furnished to a patient receiving other outpatient hospital services on the same day: generally bundled into the OPPS Ambulatory Payment Classification for the primary service. The lab is not separately payable under the CLFS in this scenario.
• Hospital outpatient laboratory tests furnished as a standalone service (no other outpatient hospital services on the same day): separately payable under the CLFS.
• Hospital inpatient laboratory tests: bundled into the IPPS Diagnosis-Related Group payment for the admission. Not separately payable.
• Physician office laboratory and independent laboratory tests: paid under the CLFS.

These distinctions affect both supplier payment and (because CLFS tests are exempt from cost-sharing while OPPS-bundled tests follow OPPS cost-sharing) beneficiary cost-sharing.

Palmetto GBA Jurisdiction J for Georgia Part B Claims

Palmetto GBA is the Medicare Administrative Contractor for Part B claims in Jurisdiction J, which covers Georgia, Alabama, and Tennessee. Palmetto's responsibilities include:

• Claims processing and payment for clinical laboratory services
• Local Coverage Determinations for tests not addressed by NCDs
• Initial appeals (redetermination, the first level of the Medicare five-level appeals process)
• Coding and billing education for laboratories and ordering providers
• Provider enrollment for Georgia laboratories

Palmetto GBA Jurisdiction J contact information is available at palmettogba.com.

The Georgia Laboratory Landscape

Hospital central laboratories

Each major Georgia hospital system operates a central laboratory and one or more satellite laboratories for its inpatient, outpatient, and physician practice testing volume. Major Georgia hospital laboratories include those at Emory Healthcare (Atlanta), Piedmont Healthcare (statewide), Wellstar Health System, Northeast Georgia Health System (Gainesville), Memorial Health (Savannah), Augusta University Health, Atrium Health Navicent (Macon), Phoebe Putney (Albany), and Grady Health System (Atlanta).

National laboratory chains

Two major national laboratory chains have extensive Georgia operations:

• LabCorp (Laboratory Corporation of America Holdings): Burlington, North Carolina headquartered, with hundreds of patient service centers across Georgia and an extensive network of in-office partnerships with Georgia physician practices.
• Quest Diagnostics: Secaucus, New Jersey headquartered, with hundreds of patient service centers across Georgia and a similar in-office partnership network.

Both operate hub-and-spoke logistics with regional core laboratories serving Georgia and surrounding states, plus specialized national laboratories for complex molecular and pathology testing.

Specialty and reference laboratories

For complex testing not performed by hospital or national chain laboratories, specimens may be sent to:

• Foundation Medicine, Tempus, NeoGenomics, Caris Life Sciences (oncology genomics)
• Mayo Clinic Laboratories, ARUP Laboratories (reference testing)
• Ambry Genetics, GeneDx, Invitae (hereditary cancer and genetic testing)

Physician office laboratories

Many Georgia primary care, urgent care, and specialty physician practices operate small office laboratories with CLIA Certificates of Waiver or Provider-Performed Microscopy certifications. Common point-of-care tests include fingerstick glucose, urinalysis, rapid strep, rapid flu, and INR.

Georgia Department of Public Health Bureau of Laboratories

The Georgia DPH Bureau of Laboratories is the state public health laboratory located in Decatur, Georgia. It performs newborn screening, infectious disease surveillance testing, environmental testing, and emergency response testing. Phone 404-327-7900.

Worked Examples: Georgia Medicare Clinical Laboratory Beneficiary Scenarios

Example 1: Margaret, 78, Atlanta, annual blood work at Piedmont Atlanta laboratory

Margaret attends her annual wellness visit at Piedmont Atlanta. Her primary care physician orders complete blood count (CBC, HCPCS 85025) and comprehensive metabolic panel (CMP, HCPCS 80053).

The Piedmont phlebotomist draws the specimen. The specimens are run on automated analyzers in the Piedmont central laboratory. Results return to the physician within 24 hours.

Billing:

• HCPCS 85025 CBC: paid under CLFS
• HCPCS 80053 CMP: paid under CLFS
• HCPCS 36415 venipuncture: paid under Part B

Margaret's cost-sharing: $0 on the lab tests (CLFS cost-sharing exemption). She owes Part B coinsurance on the venipuncture and the physician visit, covered by her Medigap Plan G.

Example 2: Robert, 82, Savannah, annual PSA screening at Memorial Health Imaging and Outpatient Services

Robert receives annual PSA screening as part of his preventive care. His physician orders total PSA (HCPCS 84153) as a screening test.

The blood draw is performed at Memorial Health Outpatient Services laboratory. The sample is run on Memorial's chemistry analyzer.

Billing:

• HCPCS 84153 PSA screening: paid under CLFS as preventive screening
• $0 cost-sharing under the preventive services provision

If the PSA is elevated and Robert's urologist orders a reflex free PSA (HCPCS 84154) for borderline cases, that test would be diagnostic rather than screening but still on the CLFS, so cost-sharing remains $0.

Example 3: Linda, 75, Macon, bone marrow biopsy with pathology at Atrium Health Navicent

Linda has new-onset anemia of unclear etiology. Her hematologist at Atrium Health Navicent performs a bone marrow biopsy in the outpatient setting.

Billing:

• HCPCS 38221 bone marrow biopsy procedure: paid under MPFS (physician fee schedule)
• HCPCS 88305 surgical pathology gross/microscopic examination Level IV: paid under MPFS
• HCPCS 88312 special stain Group I and 88313 special stain Group II: paid under MPFS
• HCPCS 88184/88185 flow cytometry: paid under MPFS

These services are not on the CLFS because they require professional interpretation by a pathologist. Linda pays 20 percent coinsurance after Part B deductible on the MPFS-paid services. Her Medigap covers.

The actual specimen processing and laboratory technician work is bundled into the technical component of the MPFS-paid services.

Example 4: Charles, 80, Augusta, newly diagnosed colorectal adenocarcinoma with tumor markers and oncology genomics at AU Medical Center

Charles is diagnosed with stage III colon adenocarcinoma after colonoscopy and biopsy at Augusta University Medical Center. The oncology team orders multiple laboratory tests:

• Tumor markers: CEA (HCPCS 82378), CA 19-9 (HCPCS 86301). Paid under CLFS. $0 cost-sharing.
• Molecular pathology: KRAS, NRAS, BRAF mutation testing on the tumor specimen (HCPCS 81210, 81311, 81406, etc.). Paid under CLFS (some codes) or MPFS (some codes depending on whether interpretation is required).
• Mismatch repair (MMR) immunohistochemistry: HCPCS 88341 for each marker (MLH1, MSH2, MSH6, PMS2). Paid under MPFS as pathology professional service.
• Microsatellite instability (MSI) testing: HCPCS 81301. Paid under CLFS.
• Comprehensive genomic profiling: if the oncologist orders Foundation Medicine FoundationOne CDx (an FDA-approved companion diagnostic), the test may qualify as an Advanced Diagnostic Laboratory Test under Section 1834A.

Charles's cost-sharing: $0 on CLFS tests. 20 percent coinsurance on MPFS-paid pathology services, covered by Medigap.

Example 5: Patricia, 73, Columbus, screening mammography and screening pap smear

Patricia receives her annual preventive care at Piedmont Columbus. Her physician orders screening mammography and a screening pap smear.

Screening mammography:

• HCPCS 77067 screening mammography, bilateral
• $0 cost-sharing under ACA 2010 Section 4104

Screening pap smear:

• HCPCS Q0091 obtaining screening pap specimen (PCP visit)
• HCPCS 88142 pap test, monolayer preparation
• $0 cost-sharing

Example 6: Henry, 85, Athens, dual-eligible QMB, homebound monthly INR monitoring

Henry is bedbound at home in Athens, Georgia. He has atrial fibrillation requiring warfarin anticoagulation with monthly INR monitoring.

His primary care physician orders monthly INR (HCPCS 85610). LabCorp mobile phlebotomy serves Henry's home each month.

Billing:

• HCPCS 85610 prothrombin time/INR: paid under CLFS, $0 cost-sharing
• HCPCS G0471 collection of venous blood in homebound setting: paid under Part B
• HCPCS P9604 travel allowance, flat fee per visit

Henry is QMB enrolled in Georgia Medicaid. Georgia Medicaid covers any Medicare cost-sharing under Section 1902(n)(3)(B). LabCorp must accept the Medicare-allowed amount as payment in full and cannot balance bill Henry.

Fourteen Common Mistakes Georgia Medicare Laboratory Beneficiaries Should Avoid

1. Assuming a non-CLIA-certified laboratory can bill Medicare. Every laboratory testing Medicare specimens must have an appropriate CLIA certificate. Confirm CLIA certification before service.

2. Missing the diagnosis-code requirement supporting medical necessity. Laboratory claims must include ICD-10 diagnosis codes that establish medical necessity under the applicable NCD or LCD.

3. Confusing screening with diagnostic testing. Screening tests have specific frequency limits and may have different cost-sharing rules.

4. Not understanding the CLFS cost-sharing exemption. No Part B deductible, no 20 percent coinsurance for clinical laboratory tests paid under the CLFS.

5. Ordering tests outside applicable NCD criteria. A PSA test for a patient without covered indications is unlikely to be covered for screening purposes.

6. Confusing CLFS with MPFS. Anatomic pathology services (biopsy interpretation, special stains, immunohistochemistry interpretation) are paid under MPFS, not CLFS, and follow MPFS cost-sharing.

7. Allowing improper balance billing for CLFS tests. Participating Medicare laboratories must accept the CLFS allowed amount as payment in full and cannot balance bill.

8. Not appealing denied lab claims through Palmetto GBA redetermination. The first level of appeal is available for any denial.

9. Missing the screening pap smear or mammography frequency rules. These preventive services have statutory frequency limits; review current Medicare guidelines before ordering.

10. Failing to obtain an Advance Beneficiary Notice (ABN) when the supplier expects denial. Without an ABN, the supplier cannot bill the beneficiary for a denied service.

11. Not recognizing the difference between Independent Laboratory and Independent Diagnostic Testing Facility for billing. IDTFs have separate enrollment and performance standards.

12. Confusing a CLIA Certificate of Waiver with full CLIA certification. Waived certificate laboratories can only perform FDA-categorized waived tests.

13. Allowing improper billing for unbundled tests. Some tests must be billed as a panel HCPCS (e.g., 80053 CMP) rather than individual component HCPCS codes.

14. Missing the COVID-19 testing rules post-public health emergency. The CARES Act $0 cost-sharing for diagnostic COVID-19 testing applied during the PHE; post-PHE, standard Part B rules apply for tests not paired with a covered medical visit.

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Frequently Asked Questions About the Georgia Medicare Clinical Laboratory Services Benefit

1. What laboratory tests does Medicare cover? Medicare Part B covers diagnostic laboratory tests under Section 1861(s)(3) of the Social Security Act, including blood chemistry, hematology, microbiology, immunology, urinalysis, molecular pathology, and pathology. Coverage requires that the test be reasonable and necessary for diagnosis or treatment, ordered by the treating physician, and consistent with any applicable National or Local Coverage Determination.

2. How much do I pay for laboratory tests under Medicare? For clinical laboratory tests paid under the Clinical Laboratory Fee Schedule, you pay $0: no Part B deductible, no 20 percent coinsurance. This long-standing exemption is at Section 1833(a)(1)(D)(i). For pathology services paid under the Medicare Physician Fee Schedule (such as biopsy interpretation), standard Part B cost-sharing applies (deductible plus 20 percent coinsurance).

3. What is the Clinical Laboratory Fee Schedule? The Clinical Laboratory Fee Schedule (CLFS), established by Section 1833(h) of the Social Security Act, is the national fee schedule that pays for clinical diagnostic laboratory tests in Medicare. The original CLFS was enacted by the Deficit Reduction Act of 1984. The Protecting Access to Medicare Act of 2014 fundamentally restructured the CLFS through Section 1834A, requiring labs to report private payer rates so that CMS could calculate market-based rates.

4. What is PAMA 2014 and how did it change laboratory payment? The Protecting Access to Medicare Act of 2014 added Section 1834A to the Social Security Act, establishing a market-based payment methodology for the CLFS. "Applicable laboratories" report private payer rate and volume data; CMS calculates weighted median rates that become the new CLFS rates. Payment reductions are capped by statute per applicable year (subject to delays).

5. What is CLIA? The Clinical Laboratory Improvement Amendments of 1988 (Public Law 100-578), codified at 42 U.S.C. 263a, establish federal quality and personnel standards for all laboratories testing human specimens. CLIA categorizes tests as waived, moderate-complexity, or high-complexity, and establishes corresponding personnel and quality requirements. All laboratories testing Medicare specimens must have an appropriate CLIA certificate.

6. What are the three CLIA certificate types? (1) Certificate of Waiver: for laboratories performing only FDA-categorized waived tests. (2) Provider-Performed Microscopy: for physicians personally performing certain direct microscopy. (3) Certificate of Compliance or Certificate of Accreditation: for laboratories performing moderate-complexity, high-complexity, or PPM tests. CoC laboratories are surveyed by CMS or state survey agency; CoA laboratories are surveyed by CMS-deemed Accreditation Organizations such as CAP, TJC, COLA, AABB, or ASHI.

7. What is a National Coverage Determination? A National Coverage Determination (NCD) under Section 1869(f) is a CMS-issued determination of whether a specific service is covered nationally. Multiple NCDs specifically address laboratory tests, including PSA, thyroid testing, lipid testing, hemoglobin A1c, and others.

8. What is a Local Coverage Determination? A Local Coverage Determination (LCD) is a coverage policy issued by a Medicare Administrative Contractor that applies only within the MAC's jurisdiction. For Georgia, Palmetto GBA Jurisdiction J issues LCDs that apply in Georgia, Alabama, and Tennessee.

9. What is the screening mammography benefit under Medicare? Section 1834(c) covers annual screening mammography for eligible women. There is no cost-sharing for screening mammography. Consult current Medicare guidelines for the applicable age requirements.

10. What is the screening pap smear benefit under Medicare? Section 1861(nn) covers screening pap smear and pelvic exam periodically based on risk level (more frequently for high-risk women). No cost-sharing applies. Consult current Medicare guidelines for applicable frequency limits.

11. What is the screening colorectal cancer benefit under Medicare? Section 1834(g) covers multiple colorectal cancer screening modalities: fecal occult blood test or fecal immunochemical test; multi-target stool DNA test (Cologuard); flexible sigmoidoscopy; and screening colonoscopy. Each modality has specific frequency and eligibility requirements under current Medicare guidelines. The Consolidated Appropriations Act of 2021 phased in reduced coinsurance for screening colonoscopy converted to diagnostic when a polyp is removed.

12. Can my doctor order any lab test for me? Yes, but Medicare will only pay for tests that are reasonable and necessary, ordered by the treating physician, and consistent with any applicable NCD or LCD. Tests outside coverage criteria may be denied, and the patient may be billed if an Advance Beneficiary Notice (ABN, CMS-R-131) was obtained in advance.

13. What is an Advance Beneficiary Notice (ABN)? An ABN (CMS-R-131) is a written notice from a provider to a Medicare beneficiary that a specific service may not be covered by Medicare. The beneficiary must sign the ABN before service. If the service is later denied by Medicare, the beneficiary is responsible for payment.

14. What is an Independent Diagnostic Testing Facility? An Independent Diagnostic Testing Facility (IDTF) is a Medicare provider type under 42 CFR 410.33. IDTFs furnish diagnostic procedures with physician supervision. Examples include freestanding imaging centers, sleep study centers, and EKG laboratories. IDTFs must meet 14 specific performance standards.

15. Who is Palmetto GBA and why does it matter for Georgia laboratory claims? Palmetto GBA is the Medicare Administrative Contractor for Part B claims in Jurisdiction J: Georgia, Alabama, and Tennessee. Palmetto processes Georgia laboratory claims, issues LCDs, and handles initial appeals. Contact information is available at palmettogba.com.

16. How do I appeal a denied laboratory claim? The Medicare appeals process has five levels: (1) Redetermination by Palmetto GBA (within the applicable filing deadline); (2) Reconsideration by a Qualified Independent Contractor (within the applicable filing deadline); (3) Administrative Law Judge hearing if the amount in controversy meets the threshold; (4) Medicare Appeals Council; (5) federal district court review.

17. Are home laboratory specimen collections covered? Yes. For homebound patients, Medicare covers specimen collection in the home with a travel allowance under HCPCS P9603/P9604 and a specimen collection fee under HCPCS G0471. LabCorp and Quest Diagnostics both offer mobile phlebotomy in metropolitan Georgia.

18. Does Medicare cover genetic testing? Yes, in specific circumstances. Genetic testing is covered when ordered by the treating physician for diagnostic purposes consistent with applicable NCDs or LCDs. Hereditary cancer testing (BRCA1/2 and others) is covered for patients meeting specific personal or family history criteria.

19. Does Medicare cover tumor genomic testing? Yes, for specific clinical scenarios. CMS coverage determinations establish coverage for FDA-approved companion diagnostic tests for advanced cancer patients. Other tumor genomic tests are covered under various LCDs depending on the test and clinical indication.

20. Does Medicare cover COVID-19 testing? The CARES Act of 2020 Section 6001 required Medicare to cover COVID-19 diagnostic testing without cost-sharing during the public health emergency. After the PHE ended, standard Part B rules apply for tests not paired with a covered medical visit.

21. Does Medicare cover home tests like at-home COVID-19 antigen tests? Generally Original Medicare does not cover over-the-counter at-home tests except in specific defined circumstances. Medicare Advantage plans may cover at-home tests as supplemental benefits.

22. What is the difference between an independent laboratory and a hospital laboratory? Independent laboratories are freestanding laboratory entities (such as LabCorp or Quest) that are not part of a hospital. Hospital laboratories are part of a hospital provider, and their billing depends on whether the test is furnished to an inpatient (bundled into IPPS), an outpatient receiving other hospital services (bundled into OPPS), or an outpatient receiving only the laboratory service (separately billable under CLFS).

23. What is the role of the Georgia Department of Public Health Bureau of Laboratories? The Georgia DPH Bureau of Laboratories is the state public health laboratory in Decatur, Georgia. It performs newborn screening, infectious disease surveillance, environmental testing, and emergency response testing. It is not a clinical service laboratory for individual Medicare beneficiaries.

24. Can a Medicare Advantage plan have different laboratory coverage than Original Medicare? Medicare Advantage plans must cover the same Section 1861(s)(3) laboratory benefit. Plans may have different networks (limiting which laboratories may be used), different prior authorization rules, and different cost-sharing structures. The CLFS cost-sharing exemption generally applies in MA but verify with the specific plan.

25. How can a Georgia Medicare beneficiary report laboratory fraud? Laboratory fraud (medically unnecessary testing, kickbacks, upcoding, billing for tests not performed, balance billing in violation of Medicare rules) may be reported to: (1) HHS Office of Inspector General hotline at 1-800-HHS-TIPS (1-800-447-8477); (2) 1-800-MEDICARE; (3) GeorgiaCares Senior Medicare Patrol at 1-866-552-4464; (4) Georgia Attorney General's Medicaid Fraud Control Unit at 404-656-3300. :::

::: cta Georgia Medicare Clinical Laboratory Services Benefit: Where to Get Help

If you or a family member needs help with a laboratory test, coverage question, or appeal in Georgia, the following resources can help. Brevy compiles these contacts as a service to Georgia families and updates them regularly at brevy.com.

• 1-800-MEDICARE (1-800-633-4227): Medicare general information, claims questions, plan choices.
• Palmetto GBA Jurisdiction J (Part B MAC for Georgia): Part B laboratory claims, Local Coverage Determinations, redetermination appeals. Contact information at palmettogba.com.
• GeorgiaCares (Georgia SHIP) at 1-866-552-4464: free, unbiased Medicare counseling and Senior Medicare Patrol fraud reporting.
• CMS CLIA Program at 410-786-3531: CLIA certification, laboratory quality, and CLIA-related complaints.
• Georgia Department of Public Health Bureau of Laboratories at 404-327-7900: state public health laboratory.
• KEPRO (Beneficiary and Family Centered Care Quality Improvement Organization for Georgia) at 1-844-455-8708: quality of care complaints.
• Georgia Department of Community Health (DCH) Medicaid Member Services at 1-866-211-0950: Medicaid coordination, dual-eligible questions, QMB billing protections.
• Social Security Administration at 1-800-772-1213: Medicare enrollment.
• Medicare Rights Center at 1-800-333-4114: independent counseling on Medicare coverage and appeals.
• Center for Medicare Advocacy at 1-860-456-7790: legal advocacy on Medicare coverage and appeals.
• Atlanta Legal Aid Society Senior Citizens Law Project at 404-377-0701: free legal assistance for Medicare beneficiaries 60 and over in metropolitan Atlanta.
• Georgia Legal Services Program at 1-800-498-9469: free legal assistance for Medicare beneficiaries outside metropolitan Atlanta.
• HHS Office of Inspector General Hotline at 1-800-447-8477: Medicare fraud and improper billing reports.
• HHS Office of Civil Rights at 1-800-368-1019: discrimination complaints.
• Eldercare Locator at 1-800-677-1116: connects callers to Georgia Area Agencies on Aging.
• VA Benefits at 1-800-827-1000: for veterans who may have VA laboratory coverage.
• 211 Georgia: connects to community resources statewide.
• Brevy at brevy.com: comprehensive eldercare guides covering Medicare, Medicaid, VA benefits, and caregiving for Georgia families and across the country. Brevy is not affiliated with the federal government or with the State of Georgia.

This guide is for general educational purposes only and is not legal advice or medical advice. Specific cases should be discussed with a licensed attorney, certified Medicare counselor, or qualified medical provider. Brevy is committed to providing the most trustworthy and current eldercare information available; please report any inaccuracies to our editorial team at brevy.com.

Find personalized help navigating Georgia Medicare clinical laboratory benefits at brevy.com. :::