- Change to Roster Claims Information Entry in the Fiscal Intermediary Standard System Direct Data Entry
- Drugs and Biologicals - Coverage and Billing
- Medicare Part B Drug Coverage
- Covered Medicare Part B Drugs/Biologicals
- Self-Administered Drug Exclusion
- Medicare Part B General Billing
- Discarded Drugs/Wastage and JW, JZ Modifier
- Chemotherapy General Infusion Information
- Unlisted Codes for Drugs and Biologicals (J3490, J3590 and J9999)
- Compound Drugs
- Patient-Supplied or Free-of-Charge Drugs
- Prolonged Drug and Biological Infusions Using an External Pump
- Coding for Sinuva™ Claims
- Radiopharmaceutical Reimbursement
- Dermal Injections for Treatment of Facial Lipodystrophy Syndrome
- Factor VIII Billing
- Intravitreal Beovu (Brolucizumab-dbl) Billing
- Proper Billing for LEQVIO® HCPCS Code J1306
- Erythropoiesis Stimulating Agents: Clinical Indications and Coverage Criteria Overview
- Proper Billing for TEZSPIRE™ HCPCS Code J2356
- Proper Billing Units for HCPCS Code J7320
- Providers Performing Facet Joint Injections (CPT Code 64476)
- Skin Substitutes
- Vaccines
- Related Content
Covered Medicare Part B Drugs/Biologicals
Each drug and biologic that can be considered for coverage under Medicare Part B has its own set of coverage guidelines.
Below are examples of covered Medicare Part B drugs and biologicals, which may not be inclusive, along with a resource for coverage information.
Antigens
CMS allows Medicare Part B payment for a reasonable supply of antigens that have been prepared for a particular patient if:
- the antigens are prepared by a physician who is a Doctor of Medicine or osteopathy and
- the physician who prepared the antigens has examined the patient, determined a plan of treatment and the dosage regimen.
Note: CMS determined a reasonable supply of antigens is considered to be not more than a 12-month supply prepared at any one time.
Review CMS Internet-Only Manual (IOM) Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.4.4.1 for additional guidance.
Blood Clotting Factors
Medicare Part B provides coverage of self-administered blood clotting factors for hemophilia patients who are competent to use such factors to control bleeding without medical supervision.
There are two reasons you may need to split your claim:
- If the submitted amount exceeds $99,999.99
- If the units exceed the allowed 9,999 units per line item
If you submit electronically, you’ll split the service into two claims. If you submit via paper, you can bill on one line or submit the charges on two claims. Either way you must submit the units of service in item 19 on the CMS-1500 form or the electronic equivalent and append modifier 76.
Include the dose and frequency in the claim comment field (Loop 2300) NTE Segment to avoid an ADR. If comments are left out, a claim ADR will be issued to obtain the information and payment will be delayed.
Review MLN Matters® MM10474 Revised: Diagnosis Code Update for Add-on Payments for Blood Clotting Factor Administered to Hemophilia Inpatients for additional guidance.
DME Drugs
Medicare Part B will consider coverage of a nebulizer, compressor and related accessories when the patient’s medical record verifies that the patient has a condition that requires certain inhalation medication.
Under the DME benefit, Medicare does not reimburse for inhalation drugs unless they are administered with a nebulizer compressor; however, coverage may be available through other Medicare benefits such as Part D.
Review Durable Medical Equipment, Prosthetics, Orthotics and Supplies for additional guidance.
Injectable and Infused Drugs
Medicare Part B covers most injectable and infused drugs given by a licensed medical provider. There are CPT codes for several different types of infusions and injections for drugs and biologicals. These include codes for chemotherapy infusions and injections, therapeutic, prophylactic, and diagnostic infusions/injections, and hydration.
Billing Reminders:
- The start and stop times must be evident in the documentation in order to bill units for hours infused. If no start and stop time or total hours infused can be determined from the providers documentation, the best course is for you to query the clinician.
- The use of a doctor’s order or pharmacy directive/label to calculate times is not appropriate as correct coding is based on how incidents/services occur; not how services are planned.
Review Chemotherapy General Infusion Information for additional guidance.
Injectable Osteoporosis Drugs
Medicare Part B will cover Injectable osteoporosis drugs when specific indications are met.
Hypovitaminosis D may result from inadequate intake, insufficient sunlight, malabsorption, liver, kidney and genetic disease. It results in the inadequate mineralization of bone.
Review Local Coverage Determination L37535 – Vitamin D Assay Testing for additional guidance.
IVIG
IVIG is a blood product containing human immunoglobulins specifically prepared for intravenous infusion.
IVIG is used in the treatment of primary immunodeficiency diseases featuring low or dysfunctional antibody levels to prevent infection and for certain inflammatory, autoimmune and other diseases featuring to interfere with harmful antibodies and/or for blocking damage from immune cells.
Billing Reminders:
- The dose and frequency of administration should be consistent with the FDA approved package insert. When dose and/or frequency are different from the FDA approved package insert, literature to support the specific schedule chosen should be available.
- Claims submitted for procedures performed at unusually frequent intervals or high dosages may be reviewed for medical necessity.
- If coverage of IVIG is denied, the administration and pre-administration services associated with IVIG will also be denied.
Review L39314 Off-Label Use of Intravenous Immune Globulin (IVIG) for additional guidance.
Oral Anti-Nausea Drugs
Medicare Part B covers anti-nausea drugs when the following apply:
- Administered immediately before, at, or within 48 hours after chemotherapy
- Used as a full therapeutic replacement for an intravenous anti-nausea drug
Review CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.5.4 for additional guidance.
Oral Cancer Drugs
Medicare Part B covers anti-nausea drugs when the following apply:
- The same drug is available in injectable form, or
- The drug is a prodrug of the injectable or oral form
Review CMS IOM Publication 100-04, Medicare Claims Processing Manual, Chapter 17, Section 80.1 for additional guidance.
Parenteral and Enteral Nutrition (Intravenous and Tube Feeding)
This prosthetic benefit is covered by Medicare for individuals with “permanent” dysfunction of the digestive tract. When the medical record documentation, including the judgment or the attending physician, indicates that the impairment will be a long and indefinite duration, then the test of permanence is met.
Parenteral nutrition is considered reasonable and necessary for:
- A patient with severe pathology of the alimentary tract which does not allow absorption of sufficient nutrients to maintain weight and strength commensurate with the patient’s general condition.
Enteral nutrition is considered reasonable and necessary for:
- A patient with a functioning gastrointestinal tract who, due to pathology to, or nonfunction of, the structures that normally permit food to reach the digestive tract, cannot maintain weight and strength corresponding with his or her general condition.
For both parenteral and enteral nutrition therapy to be covered under Part B, the claim must contain a physician’s written order or prescription and sufficient medical documentation to permit an independent conclusion that the requirements of the prosthetic device benefit are met, and parental nutrition therapy is medically necessary.
Review NCD 180.2: Enteral and Parenteral Nutritional Therapy for additional guidance.
Oral ESRD Drugs
Medicare Part B helps pay for some oral ESRD drugs if:
- The same drug is available in injectable form, and
- The drug is covered under the Part B ESRD benefit
Review CMS IOM Publication 100-04, Medicare Claims Processing Manual, Chapter 8 for additional guidance.
ESA
ESA treatment for anemia secondary to myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphoma, and lymphocytic leukemia. Medicare Part B will consider coverage when specific indications are met.
It is considered not reasonable and necessary for beneficiaries with the following clinical conditions:
- Damaging effect of the ESA on their underlying disease
- The underlying disease increases their risk of adverse effects related to ESA use
Review NCD 110.21: Erythropoiesis Stimulating Agents (ESAs) in Cancer and Related Neoplastic Conditions for additional guidance.
Transplant Drugs
Medicare Part B will cover FDA approved drug therapy if a persons organ transplant was also covered by Medicare.
- If a person has Medicare only because of ESRD, their Medicare coverage will end 36 months after the month of a successful kidney transplant unless they’re otherwise eligible for Medicare. Note: People without certain types of other insurance coverage who lose Medicare 36 months after a successful kidney transplant can sign up for a new benefit that only covers their immunosuppressive drugs. It isn’t a substitute for full health coverage.
- Part D may cover other immunosuppressive drugs that Part B doesn’t cover. A person with ESRD can get Part D coverage by signing up for Original Medicare and joining a Medicare drug plan, or by signing up for a Medicare Advantage Plan with drug coverage.
Review CMS IOM Publication 100-04, Medicare Claims Processing Manual, Chapter 17, Section 80.3 for additional guidance.
Revised 4/29/2024