Biosimilars – Industry News, May 2022


With the ever-rising cost of cancer treatments, biosimilars provide opportunities for treatment to patients with limited access to patented originator biotherapeutics.

Biosimilar refers to those biotherapeutic produces which are extremely similar in quality, safety, and efficacy to an existing licensed originator product but are not considered identical chemical copies. The International Society of Oncology Pharmacy Practitioners (ISOPP) global position on the use of biosimilars in cancer treatment and supportive care states: “A thorough understanding of these differences and their clinical implications is necessary for optimising medicines-use practices involving biosimilars. ISOPP believes that training and education are paramount to ensure the safe and effective use of biosimilars within healthcare institutions.”

The Food and Drug Administration (FDA) has a Biosimilar Curriculum Toolkit which includes both Foundational Concepts and Regulatory and Scientific Concepts along with videos and exercises to complement the educational material.

AUC Full Implementation – Is It Happening?

After experiencing several delays as well as a call for repeal from several medical imaging societies, the penalty phase of the Appropriate Use Criteria (AUC) Program may be implemented starting January 1, 2023; dependent on the end of the public health emergency (PHE).

The 2022 Physician Fee Schedule Final Rule outlined that the AUC program will be fully implemented starting January 1, 2023, OR the January 1 that follows the declared end of the PHE for the COVID-19 pandemic. While the PHE has seen several extensions since the initial declaration and is currently extended into July 2022 with the expectation it will be renewed again for an additional 90 days, it is uncertain if it will extend into 2023.

With the uncertainty surrounding the full implementation of the AUC program, including penalties for non-compliance, practices are gearing up now in preparation for the possibility of a January 1, 2023, start date. Upon full implementation, ordering physicians will be required to consult an approved qualified clinical decision-support mechanism (CDSM) before ordering advanced imaging exams for outpatient Medicare Part B beneficiaries. If the CDSM consult is not completed or the proper result codes are not reported by the radiologist, payment for both the professional and technical portions of the service will be denied.

While the full implementation start date of the penalty phase for the AUC remains uncertain, practices are being advised to be prepared for the earliest possible date.

ACR Passes Paid Family Medical Leave Resolution

The American College of Radiology (ACR) passed a resolution this month to recommend physicians be provided with up to twelve weeks of paid family and medical leave per year. The resolution is aimed at all practices, departments and training programs for all modalities and specialties.

The ACR called family and medical leave a “critical component” of maintaining the health and wellbeing of radiologists. The Family Medical Leave Act (FMLA) guarantees up to 12 work weeks of unpaid leave for certain eligible employees for childbirth and care, serious health conditions, or caring for an immediate family member who is seriously ill.

The ACR also provided recommendations for reducing the cost of paid leave, such as utilizing short term disability insurance or creating a practice fund to help offset family and medical leave costs.

Shifts in LDCT

Low Dose Computed Tomography (LDCT) for lung cancer screening is an important tool in detecting early-stage lung cancer, which can directly affect a patient’s survival rate. There are many changes to be aware of with national policy updates, future updates in quality assurance metrics, and a negative trend in compliance that is affecting reimbursement.

In 2021, The US Preventive Services Task Force (USPSTF) released its revised recommendations on Screening for Lung Cancer. Their recommendation lowered the screening age from 55 years to 50 years and reduced the 30 pack-year metric to a 20 pack-year metric for individuals who should be screened for lung cancer yearly using LDCT.

Following the USPSTF recommendations, The Centers for Medicare and Medicaid Services (CMS) released an updated version of their Lung Cancer Screening with Low Dose Computed Tomography (LDCT) National Coverage Determination (NCD) to expand their coverage of screening to include the recommendations. They also released an MLN Matters article outlining the changes in line with the recommendations.

One of the main stipulations outlined within the LDCT NCD is the required counseling and shared decision-making (SDM) visit with the beneficiary before their first screening. The NCD highlights the four main components of the SDM visit that must be performed and documented within the patient’s electronic medical record (EMR). The encounter and subsequent documentation are requirements to ensure compliance while providing the necessary support for proper and timely reimbursement. A study published in the Journal of American College of Radiology found that an alarming number of individuals who had a LDCT for lung cancer screening did not have the required shared decision-making encounter documented within their electronic record.

At the beginning of May 2022, The American College of Radiology (ACR) announced they will be releasing updates to their Lung CT Screening Reporting & Data System (Lung-RADS). The Lung-RADS system, created in 2014 and updated last in 2019, aims to standardize lung cancer screening CT interpretations, provide guidance on follow-up imaging, and helps to monitor patient outcomes more effectively. The updates are expected to be released in the fall of 2022 and are aimed to allow clinicians to more precisely categorize and track lung cancer.

“Clinical outcome of lung cancer is related to stage at time of diagnosis.” she said. “Lung cancer is survivable if it’s found early.”
–Debra Dyer of National Jewish Health in Denver, CO

Hospital Group Warns of Global Contrast Shortage; Provides Guidance Along With ACR

On May 4, the Greater New York Hospital Association (GNYHA) warned imaging providers there is a temporary global shortage of iodinated imaging contrast, brought about in part because of the supply chain issues affecting GE Healthcare’s production of Omnipaque. GE has indicated a likely 80% reduction in supply over the next six to eight weeks due to the current COVID-19 lockdown in Shanghai, China, where Omnipaque (iohexol) is manufactured. Omnipaque is typically used for CT and x-ray procedures.

Both GNYHA and the American College of Radiology (ACR) have provided guidance for providers relating to how best to manage patients & conserve contrast during the shortage. Recommendations include evaluating current inventory, using alternative contrast distributors or brands, reviewing orders to verify contrast is necessary or a different imaging modality could be used, and minimizing doses to reduce waste.

“The ACR recognizes that this is a rapidly evolving situation,” the organization said in their statement issued May 10. “Guidance may be revised as circumstances continue to change.”

For the full ACR statement, please click here.

For ACR resources on contrast medial shortage, please click here.

CAR T-Cell Therapy Approved for Lymphoma Initial Relapse

Recently, The Food and Drug Administration (FDA) approved chimeric antigen receptor (CAR) T-cell therapy as an initial treatment for relapsed large B-cell lymphoma (LBCL).

The approval for CAR T-cell therapy as an initial treatment is designated for patients with LBCL with a proven refractory to first-line chemoimmunotherapy or has relapsed within 12 months of first-line chemoimmunotherapy. While the FDA approval does move CAR T-therapy to the earliest approved line of treatment since it was introduced to the marketplace 5 years ago, it is still not indicated for patients with primary central nervous system lymphoma.

Earlier use of the therapy was supported by findings from the ZUMA-7 trial, which was presented at the annual American Society of Hematology (ASH) meeting. The trial found that treatment with CAR T-therapy more than doubled event-free survival at 24 months. The continuing study of CAR T-therapy has also provided researchers the experience to better manage or prevent treatment side-effects making the treatment more accessible to a wider range of patients.

May Coding Corner

Within this section, current topics will be the focus. In some cases, the Q&A could reflect common questions received by Revenue Cycle Coding Strategies and in other cases, represent current issues encountered by Revenue Cycle Coding Strategies professionals.

Question: If we mix two drugs for a patient in separate bags and bring both to chair side but during the first drug infusion the patient has a reaction, can we bill for the second drug as it was intended to give even though it was never hooked up to the patient’s line? What are the guidelines around these types of scenarios from both Medicare as well as private payors? At what point, if any, is drug #2 a clinic cost vs a billable service?

Advice: Regarding drug #1 (the one partially administered) would be considered billable because a portion of the infusate has been administered, and the infusion was discontinued due to a patient contraindication, the drugs and administration can be charged to the payer. Note, it may be necessary to add Z53.09 (Procedure not carried out because of other contraindication) to the diagnosis coding help explain the scenario to the payer. Regarding drug #2 (the one not given) where drugs are mixed, but no portion of the drug was given to the patient, the drugs cannot be charged to insurance.

Medicare guidelines allow for payment of drugs administered to a patient to include the drug amount discarded up to the amount listed on the single dose vial or package label. Please note, discarded drugs are defined as the amount of the drug remaining after administration. In the scenario provided, however, no amount of drug was given, therefore, no waste would be considered billable.

Question: In a hospital setting. Can we charge a VMAT and a 3D planning charge on a scan that is all done in one day? There will be 2 different CTs but simulated the same day.

Advice: There are edits with billing VMAT and 3D on same date of service. Due to the hierarchy, a VMAT plan that is inversely planned and supports IMRT would be billed with 77301, the 3D plan (77295) would not be billable on same date as the IMRT (VMAT) plan.

Question: For an eye plaque case where sutures were used to hold the plaque in place to treat malignant melanoma and choroid mass of ciliary body OS, I should bill 77789?

Advice: If the sources are placed on the surface the correct LDR code is 77789. If they are placed interstitially, defined as within tissue, then 77778 would be the correct code. Eye plaques are surface placement, unless an unusual one where the sources are placed within the eye and the plaque holding the sources is not used.