Off-Label Drug Use: Medicare Quarterly Compliance Newsletter

on Tuesday, 28 July 2015. All News Items | Outpatient Services | Medicare Coverage | Documentation

A Team Approach

We all realize that to be effective in our jobs, we must have the cooperation of others and this is especially true when it comes to healthcare. Physicians rely on hospitals to provide the tools and services they need to care for their patients, and hospitals rely on physicians to utilize those services appropriately and to provide sufficient documentation to support coding, billing and payment. The Medicare Quarterly Compliance Newsletter for July is now available and provides several examples of issues where team work between physicians and hospitals is a must. Most of the articles in this quarter’s edition focus on physician issues, but there are a couple of articles that relate to hospital outpatient services and some instructions in the physician articles that will benefit hospitals as well.

Bevacizumab Medical Necessity (page 15 in the Compliance Newsletter)

Recovery Auditors have an automated edit to identify claims for Bevacizumab, J9035, that are incorrectly paid when they do not contain a diagnosis code required by a Local Coverage Determination (LCD). After a general description of Medicare requirements for drug coverage and identification of a specific CGS LCD that list diagnoses for a number of drugs and biologicals used to treat cancer and other acute and chronic conditions, the article discusses Medicare coverage of off-label drug usage. Drugs used for indications other than those in the approved labeling may be covered under Medicare if it is determined that the use is medically accepted, taking into consideration the major drug compendia, authoritative medical literatures, and/or accepted standards of medical practice. Some local coverage policies have been expanded to include off label usage in accordance with CMS Policy for Off Label Usage.

The Medicare Benefit Policy Manual, Chapter 15, section 50.4.5, provides guidance on the off-label use of drugs and biologicals in an anti-cancer chemotherapeutic regimen. Per the manual, “In general, a use is identified by a compendium as medically accepted if the:

  1. indication is a Category 1 or 2A in NCCN, or Class I, Class IIa, or Class IIb in DrugDex; or,
  2. narrative text in AHFS-DI or Clinical Pharmacology is supportive.

A use is not medically accepted by a compendium if the:

  1. indication is a Category 3 in NCCN or a Class III in DrugDex; or,
  2. narrative text in AHFS or Clinical Pharmacology is “not supportive.”

The complete absence of narrative text on a use is considered neither supportive nor non-supportive.”

Contractors may also determine to cover off-label uses that are supported by clinical research based on evaluation of evidence in certain specified peer-reviewed medical literature. FDA-approved drugs and biologicals may also be considered for use in the determination of medically accepted indications for off-label use if determined by the contractor to be reasonable and necessary. Refer to the complete manual instructions for specific details of coverage.

There are also a number of LCDs and Articles that address the coverage of chemotherapeutic use of Bevacizumab and off-label uses of drugs.

MACMAC Jurisdiction(s)Policy ID #Description
Cahaba J-J L29992 Drugs and Biologicals: BEVACIZUMAB (AVASTIN®)
Cahaba J-J A48896 Drugs and Biologicals - Chemotherapeutic Agents
CGS J15 A50707 Drugs and Biologicals, Coverage of, for LABEL and OFF-LABEL Uses - Supplemental Instructions Article
CGS J15 A50831 OFF-LABEL Cancer Chemotherapy Use
CGS J15 L31836 CHEMOTHERAPY and Biologicals
First Coast J-N L32094 LABEL and OFF-LABEL Coverage of Outpatient Drugs and Biologicals
National Government Services J-6 and J-K A44930 Drugs and Biologicals, Coverage of, for LABEL and OFF-LABEL Uses - Supplemental Instructions Article
National Government Services J-6 and J-K L25820 Drugs and Biologicals, Coverage of, for LABEL and OFF-LABEL Uses
National Government Services J-6 and J-K A46095 BEVACIZUMAB (Avastin™) - Related to LCD L25820
Novitas J-L A47797 Approved Drugs and Biologicals; Includes Cancer Chemotherapeutic Agents
Novitas J-H A52018 Approved Drugs and Biologicals; Includes Cancer Chemotherapeutic Agents
Palmetto J-11 A53434 CHEMOTHERAPY and Biologicals: Medicare Guidance
Wiscosin Physician Services J-5 and J-8 L28576 Chemotherapy Drugs and their Adjuncts

Providers also need to bear in mind that some Medicare Administrative Contractors (MACs) are performing probe reviews and targeted reviews on anti-cancer drugs including Bevacizumab. These reviews have significant denial rates due to lack of medical necessity, failure to follow established protocols and lack of documentation, such as physician’s orders.

So What Should Providers Do to Ensure Coverage of Anti-Cancer Treatments

  • Be aware of any coverage policies in your MAC jurisdiction and follow the diagnosis requirements.
  • For off-label use not included as covered in your MAC’s LCD, verify that your off-label usage is supported by Medicare approved standards in the pharmaceutical compendia or accepted peer-reviewed medical literature. Appeal any denials and be sure to include the supporting medical literature with your appeal.
  • Follow established and accepted protocols for anti-cancer chemotherapeutic regimens.
  • Make sure the documentation of services is complete and sufficient to support your billing.
  • Be aware of probe and targeted reviews by your MAC for anti-cancer drugs and monitor your denial rates. Take corrective actions based on denial reasons.

Other issues related to hospitals identified in the July Compliance Newsletter include:

  • Claims lacking medical necessity for hydration services based on LCD requirements (page 22)
  • Physician claims with insufficient documentation for nasal endoscopy (pg 7), lithotripsy (pg 9), and lumbar spinal fusion (pg 12). Although these reviews focused on physician services, hospital payment may also be affected as it is often dependent on the physician’s documentation. Hospitals must work with physicians to make sure the documentation for these services includes:
    • The correct date of service;
    • The reason for performing the procedure;
    • The results of the procedure;
    • A physician’s signature; and/or
    • A signature log or attestation for an illegible signature.

As often is the case, the hospital’s payment for services is dependent on the physician’s documentation and treatment choices. It must be a team effort for all providers to follow Medicare requirements and get the reimbursement they deserve.

Article by Debbie Rubio

Debbie Rubio, BS, MT (ASCP), is the Manager of Regulatory Affairs and Compliance at Medical Management Plus, Inc. Debbie has over twenty-seven years of experience in healthcare including nine years as the Clinical Compliance Coordinator at a large multi-facility health system. In her current position, Debbie monitors, interprets and communicates current and upcoming regulatory and compliance issues as they relate to specific entities concerning Medicare and other payers. You may contact Debbie at This email address is being protected from spambots. You need JavaScript enabled to view it..

This material was compiled to share information. MMP, Inc. is not offering legal advice. Every reasonable effort has been taken to ensure the information is accurate and useful.

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