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NCD Manual section 310: Clinical Trials

Section 310 of the Medicare National Coverage Determinations Manual (Pub. 100-03, chapter 1, part 4) holds 1 National Coverage Determination on clinical trials. It binds every Medicare Administrative Contractor; this page lists it with its effective date, the local policies that cite it and the contractor articles that turn it into claim edits.

Compiled from CMS files by the QuickIntell RCM Editorial Team · Data effective · Method: reference methodology · Report a data correction

Data currency: Medicare Coverage Database NCDs: API snapshot September 27, 2026 (effective September 20, 2026); Medicare Coverage Database billing and coding articles: MCD release October 8, 2026 (effective October 4, 2026). Next CMS release: weekly, every Thursday.

NCDs in the section
1
1 with a full reference page
Laboratory NCDs
0
Cited by local policies
1
8 LCD citations
With contractor articles
1
5 articles
Coverage analyses linked
2
Newest effective date
2024-05-27
NCD 310.1

Every NCD in section 310

Local policies counts the active LCDs that list the NCD as related; contractor articles counts the current Medicare Coverage Database articles that name it. NCDs with an indexed reference page are linked; the others are listed by number and title.

National Coverage Determinations in NCD Manual section 310, Clinical Trials
NCDTitleBenefit categoryEffectiveLocal policiesContractor articles
310.1Routine Costs in Clinical TrialsAmbulance Services, Ambulatory Surgical Center Facility Services, Antigens, Artificial Legs, Arms, and Eyes, Audiology Services, Blood Clotting Factors for Hemophilia Patients, Bone Mass Measurement, Certified Nurse-Midwife Services, Certified Registered Nurse Anesthetist Services, Chiropractor Services, Clinical Nurse Specialist Services, Clinical Social Worker Services, Colorectal Cancer Screening Tests, Comprehensive Outpatient Rehabilitation Facility (CORF) Services, Critical Access Hospital Services, Dentist Services, Diabetes Outpatient Self-Management Training, Diagnostic Laboratory Tests, Diagnostic Services in Outpatient Hospital, Diagnostic Tests (other), Diagnostic X-Ray Tests, Drugs and Biologicals, Durable Medical Equipment, Erythropoietin for Dialysis Patients, Extended Care Services, Eyeglasses After Cataract Surgery, Federally Qualified Health Center Services, Hepatitis B Vaccine and Administration, Home Dialysis Supplies and Equipment, Home Health Services, Hospice Care, Immunosuppressive Drugs, Incident to a physician's professional Service, Influenza Vaccine and Administration, Inpatient Hospital Services, Inpatient Psychiatric Hospital Services, Institutional Dialysis Services and Supplies, Leg, Arm, Back, and Neck Braces (orthotics), Medical Nutrition Therapy Services, Nurse Practitioner Services, Optometrist Services, Oral Anticancer Drugs, Oral Antiemetic Drugs, Orthotics and Prosthetics, Osteoporosis Drug, Outpatient Hospital Services Incident to a Physician's Service, Outpatient Occupational Therapy Services, Outpatient Physical Therapy Services, Outpatient Speech Language Pathology Services, Partial Hospitalization Services, Physician Assistant Services, Physicians' Services, Pneumococcal Vaccine and Administration, Podiatrist Services, Post-Hospital Extended Care Services, Post-Institutional Home Health Services, Prostate Cancer Screening Tests, Prosthetic Devices, Qualified Psychologist Services, Religious NonMedical Health Care Institution, Rural Health Clinic Services, Screening for Glaucoma, Screening Mammography, Screening Pap Smear, Screening Pelvic Exam, Self-Care Home Dialysis Support Services, Shoes for Patients with Diabetes, Skilled Nursing Facility, Splints, Casts, Other Devices Used for Reduction of Fractures and Dislocations, Surgical Dressings, Transplantation Services for ESRD-Entitled Beneficiaries, X-ray, Radium, and Radioactive Isotope Therapy2024-05-2785

What the section covers and how to read it

The NCD Manual groups national policies by body system or service type, and the section number is the first part of every NCD number in it. Section 310 covers clinical trials. Most of its NCDs fall under the Ambulance Services, Ambulatory Surgical Center Facility Services, Antigens, Artificial Legs, Arms, and Eyes, Audiology Services, Blood Clotting Factors for Hemophilia Patients, Bone Mass Measurement, Certified Nurse-Midwife Services, Certified Registered Nurse Anesthetist Services, Chiropractor Services, Clinical Nurse Specialist Services, Clinical Social Worker Services, Colorectal Cancer Screening Tests, Comprehensive Outpatient Rehabilitation Facility (CORF) Services, Critical Access Hospital Services, Dentist Services, Diabetes Outpatient Self-Management Training, Diagnostic Laboratory Tests, Diagnostic Services in Outpatient Hospital, Diagnostic Tests (other), Diagnostic X-Ray Tests, Drugs and Biologicals, Durable Medical Equipment, Erythropoietin for Dialysis Patients, Extended Care Services, Eyeglasses After Cataract Surgery, Federally Qualified Health Center Services, Hepatitis B Vaccine and Administration, Home Dialysis Supplies and Equipment, Home Health Services, Hospice Care, Immunosuppressive Drugs, Incident to a physician's professional Service, Influenza Vaccine and Administration, Inpatient Hospital Services, Inpatient Psychiatric Hospital Services, Institutional Dialysis Services and Supplies, Leg, Arm, Back, and Neck Braces (orthotics), Medical Nutrition Therapy Services, Nurse Practitioner Services, Optometrist Services, Oral Anticancer Drugs, Oral Antiemetic Drugs, Orthotics and Prosthetics, Osteoporosis Drug, Outpatient Hospital Services Incident to a Physician's Service, Outpatient Occupational Therapy Services, Outpatient Physical Therapy Services, Outpatient Speech Language Pathology Services, Partial Hospitalization Services, Physician Assistant Services, Physicians' Services, Pneumococcal Vaccine and Administration, Podiatrist Services, Post-Hospital Extended Care Services, Post-Institutional Home Health Services, Prostate Cancer Screening Tests, Prosthetic Devices, Qualified Psychologist Services, Religious NonMedical Health Care Institution, Rural Health Clinic Services, Screening for Glaucoma, Screening Mammography, Screening Pap Smear, Screening Pelvic Exam, Self-Care Home Dialysis Support Services, Shoes for Patients with Diabetes, Skilled Nursing Facility, Splints, Casts, Other Devices Used for Reduction of Fractures and Dislocations, Surgical Dressings, Transplantation Services for ESRD-Entitled Beneficiaries, X-ray, Radium, and Radioactive Isotope Therapy (1) benefit category, which decide whether Medicare can pay for the item at all before the NCD's clinical criteria are applied. A claim is judged against the version in force on the date of service, so the effective date and the revision history on each NCD page matter as much as the criteria.

Read an NCD in three layers. The item or service description says what the policy is about; the indications and limitations say when Medicare covers it, often with documentation, setting or frequency conditions; and the contractor articles say how the claim must be coded for the national criteria to be applied automatically. In this section 1 NCD has such contractor articles, listed on each NCD page under "How MACs bill" with their covered ICD-10-CM codes. Where a contractor has also written a Local Coverage Determination that cites the NCD, the LCD adds local documentation and coding detail but cannot narrow or widen the national coverage.

Local policies and contractor articles

1 of the 1 NCDs in this section are cited by active Local Coverage Determinations, 8 citations in all; 1 have contractor billing articles (5 articles across the Medicare Administrative Contractors). To see what applies to a claim, open the NCD, then the local policy and article of the contractor that processes it: the LCD list carries every active local policy, the LCD lookup guide explains which contractor covers which state, and the code-and-diagnosis checker tests one procedure code and one ICD-10-CM code against every article that applies in a state. A denial under an NCD returns CARC 50 with remark N386.

The most searched NCD in this section is NCD 310.1 Routine Costs in Clinical Trials, at about 260 US Google searches a month for its number.

Other sections of the NCD Manual

Chapter 1 of the manual is published in four parts on cms.gov; every section with a current NCD has its own page here.

Where QuickIntell fits in coverage checks

QuickAuth coordinates requirement checks, documentation, submission and status tracking for prior authorization with human review, so national and local coverage criteria are looked at before the service. QuickRCM picks up the claim and any coverage denial afterwards.

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Frequently asked questions

Which NCDs are in NCD Manual section 310?

Section 310, Clinical Trials, holds 1 National Coverage Determination in the current Medicare Coverage Database: 310.1 Routine Costs in Clinical Trials.

How are NCD numbers assigned?

An NCD number is its place in chapter 1 of the NCD Manual: the part before the dot is the section (310 here), and the rest orders the policies inside it. Section 310 is in part 4 of the chapter. The number stays with the policy when CMS revises it; each revision gets a new version and transmittal instead.

Do Medicare contractors add local rules to section 310 NCDs?

1 of the 1 NCDs are cited by at least one active Local Coverage Determination, and 1 have contractor articles that implement them in the Medicare Coverage Database. A local policy may add documentation and coding detail but may not contradict the national determination.

How current is this list?

It is rebuilt from the CMS Coverage API NCD records and the weekly Medicare Coverage Database article export. The most recent effective date in the section is 2024-05-27 (NCD 310.1).

Sources

Every figure on this page is taken from the CMS publications below, as released by the Centers for Medicare & Medicaid Services. Projection built 2026-10-10. Verify against the primary file before billing or contracting decisions. The reference methodology explains how each figure is computed from these files.

Disclaimer

NCD titles, dates and counts are compiled from the CMS Coverage API and the Medicare Coverage Database export as an operational reference. Coverage depends on the full policy text, the claim and the contractor; verify against the current NCD on cms.gov. Not legal, clinical or billing advice.

Found a figure that does not match the CMS file? Report a data correction with the CMS file and the value you expected; the request reaches the editorial team through the contact form.