LCD ID Number: L33394 Status: A-Approved
LCD Title: Drugs and Biologicals, Coverage of, for Label and Off-Label Uses
Geographic Jurisdiction: New York - Upstate Other Jurisdictions
Original Determination Effective Date:
Original Determination Ending Date:
Revision Effective Date:
Revision End Date:
CMS National Coverage Policy:
Language quoted from Centers for Medicare and Medicaid Services (CMS), National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See Section 1869(f)(1)(A)(i) of the Social Security Act.
Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:
Title XVIII of the Social Security Act (SSA):
Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.
Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.
CMS Publication Pub 100-02, Medicare Benefit Policy Manual, Chapter 15:
50 - Drugs and Biologicals
50.4.5 - Off-Label Use of Drugs and Biologicals in an Anti-Cancer Chemotherapeutic Regimen
CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 17:
10 - Payment Rules for Drugs and Biologicals
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