Drugs, Biologicals and Injections - JF Part B
Drugs, Biologicals and Injections
Hospitals and providers must ensure that units of drugs or biologicals administered to patients are accurately reported in terms of the dosage/units specified in the complete HCPCS code descriptor. Prior to submitting Medicare claims for drugs or biologicals, it is important to review the complete long descriptors for the applicable HCPCS codes. Providers and hospitals should not bill the units based on the way the drug is packaged, priced, stored, or stocked.
Alert: Part B Medical Review is seeing claims from providers that administer drugs, especially biologics, outside of the FDA label. This becomes a medical necessity issue; e.g., in reviewing HCPCS J3262 for Rheumatoid Arthritis, the FDA label’s directions provide the medication at 4-8 mg. per kg.
Per the provider’s documentation, they are providing the patient over the 8 mg./kg. dose, or rounding to the nearest vial. Do not provide or bill over the FDA label directions. If it involves wastage, read the modifier JW information as well.
- Unlabeled use of a drug, not included as indication on drug’s label (as approved by FDA)
- FDA approved drugs used for indications other than what indicated on official label may be covered under Medicare, if A/B MAC (B) determines use to be medically accepted
- Medicare takes into consideration major drug compendia, authoritative medical literature and/or accepted standards of medical practice
- Read more at CMS Internet Only Manual (IOM), Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.4.2 - Unlabeled Use of Drug.
Access the below related information from this page.
- Audit Findings - OIG
- Biosimilars Coverage
- Chemotherapy and Nonchemotherapy: Bundling and Unbundling of Services and Supplies
- Compounded Drugs Billing
- Determination of Approved and Accepted Off-label Drug Indications
- Documentation Requirements
- Drug Testing/Screenings Documentation
- Drug Wastage - JW and JZ Modifiers
- Hemophilia Clotting Factor Billing
- High-Cost Injections Exceeding $99,999.99
- Home Infusion Therapy (HIT)
- Implantable Infusion Pumps for Chronic Pain
- Infusion Drug Billing
- Opioid Treatment Program (OTP)
- Outpatient Drugs Administration Orders
- Pain Society Letter
- Radium 223 (Xofigo) A9606 - Updated Instructions
- Tetanus and Diphtheria Vaccinations Billing Guidelines
- Unclassified Drug Billing When Submitting EMC
Audit Findings - OIG
Recent OIG audit findings indicate a problem with providers correctly coding the number of units billed with drug and biological charges. Below are examples of drugs and biologicals HCPCS codes, code descriptions and information on units to illustrate and assist in proper billing.
|HCPCS Level II Code
|Injection, epoetin alfa (for non-ESRD use), 1000 units
|1 unit per 1000 units
|Injection, infliximab, 10 mg
|1 unit per 10 mgs
|Injection, sincalide, 5 mcg
|1 unit per 5 mcgs
|Injection, fulvestrant, 25 mg
|1 unit per 25 mgs
- Example 1 - HCPCS drug descriptor is 10 mg. 700 mgs of drug is administered to patient; units billed is 70
- Example 2 - HCPCS drug descriptor is 5 mcg. 5 mcgs of drug is administered to patient; units billed is 1
- Example 3 - HCPCs drug descriptor is 25 mg. 250 mgs of drug is administered to patient; units billed is 10
Additional findings included the following: Providers are reporting a combination of incorrect units of service and incorrect HCPCS codes. For example, provider treating prostate cancer billed 12 units of service for leuprolide acetate injection (HCPCS J1950, 3.75 milligrams per unit---total 45 mg), which is indicated for the treatment of endometriosis, uterine leiomyoma, and malignant neoplasm's of the breast; however, the provider should have billed 6 units of service for leuprolide acetate injections (HCPCS J9217, 7.5 milligrams per unit---total 45 mg), which is indicated for the treatment of prostate cancer and was the dose actually administered.
Lack of Supporting Documentation - No documentation provided to support that a patient had received the drug service billed.
Incorrect HCPCS Codes - Providers are using incorrect HCPCS codes. For example, provider billed Medicare for 200 units of bevacizumab (HCPCS code J9035); however, the provider should have billed for 200 units of azacitidine (HCPCS code J9025), the drug actually administered.
Non-covered Use of a Drug - Providers are billing Medicare for the non-covered use of an outpatient drug. For example, provider billed for a drug (plerixafor) administered during a tandem bone-marrow transplant to a beneficiary with multiple myeloma, a service (tandem bone marrow transplant) that Medicare does not consider reasonable and necessary. Medicare does not pay for drugs administered for services not considered reasonable and necessary.
Proper coding and billing of claims are necessary for accurate claim processing. Incorrect billing and documentation may result in underpayments or overpayments with subsequent recoupment and/or investigation.
The FDA approved use of biosimilars for FDA approved drugs, has increased recently. Noridian will accept a biosimilar drug on the same criteria as the drug to which it is a biosimilar unless an article is published to the contrary. These biosimilars remain subject to any FDA restrictions, if any, that do not apply to the original drug.
Compounded Drugs Billing
Compounded drugs created by a pharmacist in accordance with the Federal Food, Drug and Cosmetic Act and the FDA Modernization Act of 1997 may be covered under Medicare when their use meets all other criteria for services incident to a physician's service. Compounded drugs do not have a National Drug Code number (NDC).
Mixing two or more pre-packaged products in the same syringe when prepared according to label instructions, does not meet the definition of a compounded drug.
Compounded drugs are used to meet the special needs of a patient. Examples of when a compounded drug is used include, but are not limited to the following:
- Patient is allergic to an inactive ingredient in off-the-shelf drug and a compound is made omitting that ingredient
- Dosage strength required is not available when prepared according to label instructions. (For drugs requiring reconstitution, this means after drug has been reconstituted per label instructions.) For example, a drug used in an infusion pump or reservoir may require compounding
Since the compounded medications do not have an NDC, specific HCPCS J-codes cannot be used. Instead, providers should bill J3490 (unclassified drugs); J3590 (unclassified biologics); J7999 (compounded drug, not Oral) or J9999 (Not Otherwise Classified (NOC), antineoplastic drug).
When billing for a compounded drug, the information must be put into item 19 of the CMS-1500 paper claim form or the electronic equivalent. Providers should indicate the drug is compounded and include the drug name and total dosage given for each drug.
- Bill JXXXX for one (1) unit of service
- Include compound verbiage or abbreviation (CMP) to indicate a compounded drug
- Drug name(s) and dosage(s)
- Route administration if multiple routes
If any of the required information is not submitted, it will be denied as unprocessable.
Noridian does not reimburse separately for a compounding fee.
Outpatient Drugs Administration Orders
Coverage for outpatient drugs requires that documentation must support that services were properly authenticated or intended by the physician. While a physician order is not required to be signed, the physician must clearly document in the medical record his or her intent that the service or test be performed. Orders are a communication requesting services be completed, and may be signed by:
- Doctor of Medicine (MD)
- Doctor of Osteopathy (DO)
- Doctor of Dental Surgery (DDS)
- Doctor of Dental Medicine (DM)
- Doctor of Optometry
- Non Physician Practitioners (NPP), such as Nurse Practitioner (NP) or Physician Assistant (PA)
A Doctor of Pharmacy (Pharm D) is not an authorized CMS provider and is unable to write orders for Medicare purposes. While Pharm Ds may act within their state license for functions, they are not considered an authorized CMS billing provider. As such, any orders written or transcribed by a Pharm D need to be cosigned by an authorized provider listed above.
It is important for providers to submit all applicable documentation to substantiate services as billed and support the medical necessity of services rendered.
See the Documentation Guidelines for Medicare Services webpage for more information on signature requirements.
Radium 223 (Xofigo) A9606 - Updated Instructions
Noridian will no longer require the submission of the invoice price for payment for Radium 223 (Xofigo). This radiopharmaceutical should be billed with A9606 when billing from the Medicare Physician Fee Schedule (MPFS) on a CMS-1500 Claim Form or electronic equivalent. In the Quantity Billed column (one unit is one microcurie), enter the number of units representing the dose administered in microcuries.
Fees for radiopharmaceuticals billed through the MPFS are determined using the methods the contractor used before November 2003, (see CMS Internet Only Manual (IOM), Publication 100-04, Chapter 17, Section 20.1.3 for contractor instructions). The CMS may post an Average Wholesale Price (AWP) for use by contractors using other pricing methods.
Unclassified Drug Billing When Submitting EMC
For faster and cleaner claim processing when submitting an unclassified drug EMC (Electronic Media Claim), submit only the below required information in loop 2400/SV101-7.
- Drug name and dosage administered
Unfortunately, submitting information in both SV101-7 and Loop 2300 NTE segment or submitting extra information, slows down processing and may result in incorrect dosage calculations or denials.
- Healthcare Common Procedural Coding System (HCPCS) Manual
- CMS IOM, Publication 100-04, Medicare Claims Processing Manual, Chapter 17, Section 20.1.3 and Section 70
- CMS IOM, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50
- CMS IOM, Publication 100-03, Medicare National Coverage Determination (NCD) Manual, Chapter 1, Part 4, Section 280.14