New Palmetto JJ Part A Medical Reviews

on Tuesday, 11 December 2018. All News Items | MAC Reviews

Trust, But Verify

People do not seem to be as trusting as they once were. I believe this is in part due to the fact our lives are more complicated and complex than those of our forefathers. Technology, for example, offers numerous ways to deceive, cheat, and steal from others that did not exist 50 years ago. To be good stewards of our resources, we must be diligent against theft and deception – maybe “trust, but verify.” Medicare receives and pays billions of dollars in claims each year and for the majority of those claims, they “trust” them to be correct. But CMS also has numerous agencies and contractors who oversee the integrity of the Medicare program to ensure proper payments are being made. These contractors “verify” appropriate Medicare payments through automated claim edits and complex medical reviews.

On December 3, 2018, Medicare Administrative Contractor (MAC) Palmetto Jurisdiction J updated their list of Targeted Probe and Educate (TPE) Active Medical Reviews. They added Part A (hospital) reviews for several drugs: Rituximab (J9310), Infliximab (J1745), and Bevacizumab (J9035). These new drug reviews are in addition to still active medical reviews for drugs Pegfilgrastim (J2505) and Denosumab (J0897). Palmetto is also reviewing all of these drugs in their other MAC jurisdiction, JM.

For coverage of drugs, there first has to be a signed physician’s order for the medication. The order should specify the drug, the dosage, the route of administration, frequency, and the diagnosis or condition for which the drug is being given. Years ago, Medicare accepted the diagnosis to support medical necessity if it was simply documented on the order. They are not so trusting these days and now expect to see documentation, such as physician progress notes or a relevant history and physical, that includes a clear indication of the diagnosis, clinical signs and symptoms, prior treatments and response, and the stage of treatment if applicable. For hospitals, this often requires requesting office notes from the ordering physician to include with records submitted to Palmetto for review. Another option is to require this type of documentation up front from physicians’ offices scheduling outpatient drug infusions and maintain it in the patient’s medical record.

Another thing to consider up front is the drug protocol. Does the dose and indication for use meet the FDA-approved usage which is described in the manufacturer’s insert? Or if the drug is being used off-label, is it in accordance with Medicare approved drug compendia? This is a lot for the hospital to consider, but not knowing puts the hospital at risk of not being paid. The “recommended protocol was not ordered or followed” is a common denial reason in the published findings of prior Palmetto drug reviews. For example, here are some granular denial reasons from November 2017 findings of a Pegfilgrastim review in which 48% of the denials were for this reason:

  • For the prophylactic treatment of febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy,
    • the recommended dose of Pegfilgrastim was administered before 24 hours after administration of cytotoxic chemotherapy.
    • the recommended dose of Pegfilgrastim of less than or equal to 1-6 mg administered subcutaneously once per chemotherapy cycle was not ordered or followed.
    • the recommended dose of Pegfilgrastim is administered between 14 days before and 24 hours after administration of cytotoxic chemotherapy.
  • Pegfilgrastim was administered with contraindicated non-myelosuppressive chemotherapy.

To provide Palmetto Medical Review with more information on drug usage, a recent Palmetto article on Billing and Coding for Chemotherapy requires the inclusion of remarks on the claim to describe specifics of usage, such as drug combination therapy and the condition being treated. 

Next there must be documentation of the actual administration of the drug. The drug administration record must include the drug name, the date administered, the dosage, the route of administration, start and stop times when applicable, patient response to treatment and the signature of the clinician who administered the drug. Also remember that if the drug dosage is dependent on the patient’s weight or body surface area, that information must also be documented in the record.

Providers also need to verify they are reporting the appropriate number of units. Units are reported based on the HCPCS code description. This means if the drug descriptor is per 100 mg and 536 mg are administered to the patient, 6 units would be reported on the claim. Here is some information from a prior Wednesday@One article about the challenges of reporting drug units.

  • Drug HCPCS codes must be billed based on the amount, such as milligrams (mgs) in the HCPCS code description, not on standard usage or packaging amounts.
  • Most hospitals accomplish this by using a “multiplier” in their charge description master (CDM), which presents the challenges of making sure all drugs that need a multiplier have one, there are no errors or typos in the multiplier amounts, and the multipliers are kept updated with code description changes.
  • CMS often changes drug HCPCS codes and/or the HCPCS description. This is especially challenging when the amount in the description changes.
  • Medical record documentation should include the dosage amount in the physician’s order and in the administration record.
  • If the dose administered does not match the dosage amount the physician ordered, a corrected order should be obtained from the ordering physician.
  • If the drug dose is based on the patient’s weight, there should be documentation in the medical record of the patient’s weight.
  • Medicare has published Medically Unlikely Edits (MUEs) applicable to drug quantities for over 550 drug codes. Limits are based on anatomic or clinical considerations, prescribing information, CMS policy, or code descriptor/instructions.
  • Medicare does not allow providers to bill for wastage of multi-dose vials.
  • When billing for wastage associated with single-dose vials, there should be documentation in the medical record of the dose given and the amount wasted.

For more information on drug wastage, please see Palmetto's article on Drug Wastage Billing and Coverage Guidelines.

Hospital providers should be diligent to verify the accuracy of their claims before a Medicare reviewer does so. It is more often not an intent to deceive, but lack of knowledge or simple errors that cause inaccurate claims. Hospitals, like Medicare, should “trust, but verify.”

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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