Drugs, Biologicals and Injections - JE Part A
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.
- 340B Drug Program
- Audit Findings - OIG
- Biosimilars Coverage
- Chemotherapy Administration Billing
- Determination of Approved and Accepted Off-label Drug Indications
- Drug Wastage - JW and JZ Modifiers
- Implantable Infusion Pumps for Chronic Pain
- Initial Drug Administration
- Opioid Treatment Program (OTP)
- Outpatient Drugs Administration Orders
- Pain Society Letter
- Radium 223 (Xofigo) A9606 - Updated Instructions
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||Code Description||Units|
|J0885||Injection, epoetin alfa (for non-ESRD use), 1000 units||1 unit per 1000 units|
|J1745||Injection, infliximab, 10 mg||1 unit per 10 mgs|
|J2805||Injection, sincalide, 5 mcg||1 unit per 5 mcgs|
|J9395||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 J9035). However, the provider should have billed for 200 units of azacitidine (HCPCS 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.
Outpatient Drugs Administration Orders
Coverage for outpatient drugs requires that documentation must support that services were properly authenticated or intended by the physician. 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 Signature Requirements webpage for more information.
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-1450 Claim Form or electronic equivalent.
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.
- Healthcare Common Procedural Coding System (HCPCS) Manual
- CMS Internet Only Manual (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
- CMS Change Request (CR) 7097
Last Updated Wed, 07 Jun 2023 19:54:16 +0000