FDA’S New Cancer Trial Guidance – Industry News, March 2022

FDA Released New Cancer Trial Guidance

Following the relaunch of the White House’s Cancer Moonshot initiative, the U.S. Food and Drug Administration (FDA) issued new guidance for cancer trials to align with the goals drawn up within the initiative.

The FDA responded to the Moonshot initiative’s goals of reducing the cancer death rate and improving the experience of living with and surviving cancer by outlining new clinical trial guidance to the industry. The new guidances are as follows:

  1. Inclusion of Older Adults in Cancer Clinical Trials
    This guidance recommends enrolling patients, aged 65 years and older, in early phase clinical trials of drugs for cancer treatment when appropriate. It also includes guidance for trial design, participant recruitment, information collection, and developing and reporting more isolated age groups to encourage enrollment of older adults.
  2. Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologicals
    This guidance provides information on performing trials with multiple group extensions that allow for the concurrent collection of data on patients in different cohorts to assess safety, pharmacokinetics, and anti-tumor activity of cancer drugs. This will allow researchers to assess many different aspects of a drug within a single trial to expedite the clinical development of the drug.
  3. Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics
    Provides guidance with the goal of accelerating drug development by directing the design and conduct of clinical trials to evaluate multiple drugs, disease types, and/or patient populations in multiple sub studies. By allowing more than one investigational drug, disease, or patient population within a single clinical trial, can provide answers more quickly and efficiently than with traditional clinical trials. This guidance also advises how clinical sponsors should interact with the FDA to protect patient safety while obtaining quality data and to ensure efficient review.
“With today’s actions the FDA is recommending important principles that involve addressing inequities, targeting the right treatments to the right patients, speeding progress against the most deadly and rare cancers, and learning from the experience of all patients,” said Richard Pazdur, M.D., Director for the FDA’s Oncology Center for Excellence. “All of these are tenets of Cancer Moonshot’s mission.”

Judge Rules Against Provision in No Surprises Act

In late February, a Texas judge ruled against the dispute-resolution process detailed with the No Surprises Act citing it to be in violation of the Administrative Procedure Act.

The Texas Medical Association brought a suit against the Act in October and Judge Jeremy Kernodle ruled the Act, specifically the dispute-resolution process between providers and payers, violated the Administrative Procedure Act, which is the process by which federal agencies develop and issue regulations. Judge Kernodle’s order does not apply nationally but the federal government can appeal.

The Departments of Health and Human Services, Labor and Treasury are taking actions to comply with the Texas court’s order. Including withdrawing guidance related the dispute-resolution process that has been invalidated and providing training to certified independent dispute-resolution entities on the changes. In an update released February 28, 2022 the Department of Labor stated the Judge’s order did not affect any other rulemaking within the No Surprises Act and consumers will still be protected from surprise bills related to out-of-network emergency services.

New Therapy, Imaging Receives FDA Approval for Metastatic Prostate Treatment

The manufacturer Novartis announce Pluvicto has received U.S Food and Drug Administration (FDA) approval for treatment metastatic, castration-resistant prostate cancer, along with Locametz, a complementary diagnostic imaging agent.

Pluvicto is the first FDA-approved targeted radioligand therapy for the treatment of castration-resistant metastatic prostate cancer boasting a 38% reduced risk of death and 60% progression reduction when combined with the standard of care according to Novartis.

The FDA additionally approved imaging agent Locametz which is used to pinpoint prostate specific membrane antigen (PSMA) positive lesions via a PET scan. The Society of Nuclear Medicine and Molecular Imagining (SNMMI) has updated its appropriate use criteria for PSMA PET imaging to include evaluating patients eligibility for the radioligand therapy.

“The development of radiopharmaceutical therapies is advancing rapidly, and we fully expect there will be more to come as they can be so effective and beneficial for patients fighting cancer.”
– SNMMI President Richard L. Wahl, MD, FACNM

CAAP Percentage Increases Coming Soon

Providers with any remaining COVID-19 Accelerated or Advance Payment (CAAP) balances will see their recoupment percentages increase soon, dependent on the date of CAAP issuance. In accordance with the Continuing Appropriations Act, 2021 and Other Extensions Act, the Centers for Medicare and Medicaid Services (CMS) collected 25% over an 11-month period followed by a recovery of 50% over a six-month period. We are closing in on the one year of the current recoupment of 25 percent. It is recommended to review the repayment terms in their entirety.

Congress Extends Access to Telehealth Services

On March 10, Congress voted to allow an extension to the relaxed requirements for telehealth services provided during the pandemic. This extension was granted as part of the $1.5T Omnibus bill which was just passed.

The extension leaves the current expanded access to telehealth services in place for 151 days (or 5 months) after the end of the public health emergency, which is set to end in April but is likely to extend through July 2022.

The telehealth waivers allow Medicare coverage for telehealth visits, including certain audio-only visits, from “any site in the United States” including the patient’s home. Medicare previously only covered these services for patients in rural areas and only provided coverage for certain physicians & qualified healthcare providers. Under the extended telehealth conditions, all Medicare-enrolled providers can bill for telehealth services.

The bill also delays the requirement for beneficiaries pursuing virtual mental health care to have an in-person visit within six months of the telehealth visit.

These flexibilities for telehealth apply only to Medicare reimbursement, but private payers tend to follow Medicare guidelines.

To view the bill in its entirety, please click here.

Quarterly NCCI Updates Reflect Deleted Edits for Radiation Therapy, Inpatient Visits

The recently published quarterly CMS/NCCI procedure-to-procedure (PTP) edits contain several updates related to radiation therapy codes. These edits go into effect on April 1, 2022.

Medicare Physician Fee Schedule (MPFS) PTP edits were removed for code combinations relating to column 2 CPT® Category III codes for intradermal cancer immunotherapy (0708T and 0709T) and many radiation oncology CPT® codes (column 1), including those for infusion or instillation of radioelement solution, intracavitary radiation source application, and surface application of low dose rate radionuclide source. Additionally, edits were deleted for 0708T and 0709T (column 2) with column 1 codes G0406-G0408 (Follow-up telehealth inpatient consultation). These combinations previously had a “1” modifier indicator, which states a modifier is allowed to bypass this edit under certain circumstances, but as of April 1, no PTP edits are in place for these code combinations.

Figure 1

Please note this is not an exhaustive list of the updated PTP edits; it only provides an overview of relevant updates. A review of the quarterly NCCI MUE and PTP edits in their entirety is recommended. To view the current edits, visit this link: National Correct Coding Initiative Edits | CMS

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Billing and Coding Articles Effective 4.1.2022

  • Bevacizumab and biosimilars (A52370)
  • Filgrastim, Pegfilgrastim, Tbo-filgrastim and biosimilars (A52408)
  • Intravenous Immune Globulin (IVIG) (A52446)
  • Nivolumab (A54862)
  • Ranibizumab, Aflibercept and Brolucizuman-dbll and Faricimab-svoa (A52451)
  • Stem Cell Transplantation (A52879)

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New NCD Effective April 22: Billing and Coding: NCD Coding Article for Positron Emission Tomography (PET) Scans used for Non-Oncologic Conditions

March 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: I just finished printing a plan where we are using an Electron beam to treat a sternum and also treating the iliac using a wedge pair photon beam protecting bowel, bladder, and rectum. We used 2 different datasets for each plan (both areas scanned yesterday). Can I charge a special therapy plan (77321) and a 3D plan (77295) both on the same day or only charge 1 or the other? I printed both of them today. What codes can be charged on this case?

Advice: Yes, codes 77295 and 77321 for two different volumes and two different documented treatment plans can be billed on the same date.

Question: Can we charge/bill a special physics consult for SRS and SBRT?

Advice: It is allowable to bill a special physics consult (77370) for stereotactic courses when there is an order by the physician to address a specific reason and the work involved in addressing the physician’s request requires the expertise of a qualified medical physicist. This service would be ordered on a case-by-case basis, and it is recommended against utilizing blanket treatments/diagnoses in ordering this service. A report must be generated by the physicist addressing the specific request, which must be signed by the physician. As a reminder, 77370 should not be reported as part of the development of an IMRT plan.

Question: I have a question about codes when two different sites are used. If a patient receives Taxol, Magnesium, Benadryl, Dexamethasone, and Zofran with the times and sites below what administration codes would be used? Thank you. Taxol – L Forearm – 14:37-1737 Benadryl – L Forearm – 12:17-12:18 Dexamethasone – L Forearm – 12:19- 12:39 Zofran – L Forearm – 12:10-12:12 Magnesium – R Forearm – 11:32-13:32

Advice: It is recommended that there are very explicit orders from the physician to have the other IV site accessed and used. Because a totally different site was accessed, an additional “initial” code may be used. Per CPT and CMS guidelines, the two initial codes (one for the initial chemo from the L hand site and one for the initial therapeutic from the R hand site) would be reported on separate claim lines with a 59 modifier on the second initial code, or the therapeutic code. So, your billing scenario would be this: Taxol – L Forearm – 14:37-1737 96413 x 1, 96415 x 2 Benadryl – L Forearm – 12:17-12:18 96375 x 1 Dexamethasone – L Forearm – 12:19- 12:39 96367 x 1 Zofran – L Forearm – 12:10-12:12 96375 x 1 Magnesium – R Forearm – 11:32-13:32 96365-59 x 1, 96366 x 1 I hope this makes sense. Make sure there is adequate documentation for establishing medical necessity to have the two sites accessed.