Industry News, October 2023

Palmetto Releases Radiation Therapies LCD/LCA

Medicare Administrative Contractor (MAC) Palmetto GBA released a new Radiation Therapies Local Coverage Determination (LCD), Local Coverage Article (LCA) and an article with Response to Comments on October 19, 2023.

Palmetto Releases Radiation Therapies LCD/LCA

The Radiation Therapies LCD and LCA have a future effective date of December 3, 2024. The guidance is applicable to both Palmetto jurisdictions covering Alabama, Georgia, Tennessee, South Carolina, Virginia, West Virginia, and North Carolina. The new policies provide a comprehensive outline of documentation requirements, coding guidance, coverage indications, limitations, and/or medical necessity for IMRT, SRS, and SBRT.  Some specific information within the policies include:

• Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature and credentials of the physician, non-physician practitioner, dosimetrist, physicist or radiation therapist responsible for and providing the described care for the patient.
• *** WHEN INVERSE TREATMENT PLANNING IS PERFORMED AND THAT PLAN IS UTILIZED, THE RADIATION ONCOLOGIST OR PHYSICIST MUST DOCUMENT THAT FACT. [Despite notations of optimization or use of certain computerized systems or other data, it is still necessary for the type of treatment planning either conventional forward planning or inverse planning to be specifically documented. Collaboration with one’s electronic medical record vendor is strongly recommended to help support meeting this documentation requirement.]

While this guidance is specific to Palmetto jurisdictions, it would be beneficial for anyone to review the new policies as there is valuable information that would likely be applicable to most Medicare beneficiaries.

Resources

• Radiation Therapies LCD (L39553)
• Billing and Coding: Radiation Therapies LCA (A59350)
• Response to Comments: Radiation Therapies

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Beta-Amyloid PET NCD Removed

The Centers for Medicare and Medicaid Services (CMS) recently announced their removal of the national coverage determination (NCD) for beta-amyloid PET scans, instead allowing Medicare Administrative Contractors (MACs) to determine appropriate coverage.

CMS’ longstanding NCD restricted patients to one amyloid-detecting positron emission tomography (PET) exam in their lifetime. The removal of the restrictive policy expands access to nuclear medicine testing for patients receiving monoclonal antibody treatments for Alzheimer’s disease and nuclear testing for patients with other neurodegenerative diseases.
The Society of Nuclear Medicine and Molecular Imaging (SNMMI) recommends amyloid PET scans to confirm the presence of amyloid plaque buildup in the brain and should also be performed during treatment to monitor reduction in amyloid plaque levels for those receiving monoclonal antibody treatments. The removal of the limiting NCD and allowing MACs to determine appropriate PET coverage will help facilitate access to the management of Alzheimer’s and other dementias to Medicare beneficiaries.

SNMMI president Helen Nadel, MD, FRCPC, FSNMMI stated: “This decision ensures increased accessibility to this crucial nuclear medicine test for eligible patients and facilitates the targeted use of new treatments for those who can benefit.”

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ACR® Highlights Negative Impact of G2211
The American College of Radiology® (ACR®) along with approximately 50 additional provider groups are pushing to terminate the implementation of Healthcare Common Procedure Coding System (HCPCS) code G2211, claiming implementation will penalize clinicians who do not use the code.

Evaluation and Management (E/M) add-on HCPCS code G2211 was created in 2021 by the Centers for Medicare and Medicaid Services (CMS) to account for the inherent complexity of care related to patients with serious or complex conditions. CMS delayed reimbursement of the code until January 1, 2024. Currently, the add-on code can be reported, but is a bundled code and is not separately reimbursed. CMS has proposed to change the status indicator of the code from “B” (bundled) to “A” (active), effective January 1, 2024, within the CY 2024 proposed Medicare Physician Fee Schedule (MPFS) rules.

CMS has estimated the code would be responsible for 90% of the overall budget neutrality reduction tied to the conversion factor (CF). It is in this conversion factor reduction where the ACR and coalition of provider groups cite the penalization for clinicians who cannot or do not report G2211. The ACR refers to a 2020 analysis from Health Policy Alternative which estimated that, if the add-on code were implemented in 2021 as initially planned, diagnostic radiology would have faced one of the highest payment decreases at approximately 10.3%.
Pressing both the Senate and House, the ACR-led advocacy wishes to permanently terminate the implementation of G2211, seeking short-term relief but continues to push long term reform to MPFS as well. 
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Beta-Amyloid PET NCD Removed

The 2022 Medicare Fee-for-Service (FFS) Supplemental Improper Payment Data reflected a 46.2% improper payment rate for oral anticancer drugs with an improper payment amount totaling $8.4 million.

For the 2022 reporting period, 75% of improper payments were attributed to insufficient documentation, while 13.4% was due to no documentation and 11.5% was reported as “other” errors. Oral anticancer drugs are covered by the Centers for Medicare and Medicaid (CMS) under the oral anticancer drug benefit as well as under Section 80.1 of the Medicare Claims Processing Manual, Chapter 17. To prevent oral anticancer drug denials, all four criteria must be met:

1. It’s an FDA-approved drug or biological.
2. It has the same active ingredients as a non-self-administrable anticancer chemotherapeutic drug or biological that’s covered when given incident to a practitioner’s service. The oral anticancer drug and the non-self-administrable drug must have the same chemical or generic name as shown by the FDA’s Approved Drug Products (Orange Book), Physician’s Desk Reference (PDR), or an authoritative drug compendium, or it’s a prodrug which, when ingested, is metabolized into the same active ingredient found in the non-self-administrable form of the drug.
3. It’s used for the same anticancer chemotherapeutic indications, including unlabeled or off-label uses, as the non-self-administrable form of the drug.
4. It’s prescribed by a practitioner licensed under state law to prescribe these drugs as anticancer chemotherapeutic agents.

CMS will cover self-administered antiemetic drugs used with oral anticancer drugs if the following criteria are met:

• It’s used with a covered oral anticancer drug
• It’s likely the given covered oral anticancer drug will induce emesis if you don’t give the antiemetic drug
• You give the antiemetic drug within 2 hours before you give the covered oral anticancer drug

Resources

• Oral Anticancer Drugs LCD L33826
• Oral Anticancer Drugs LCA A52479

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Drug Companies Agree to Negotiations

All ten drug companies whose drugs were selected under the Medicare Drug Price Negotiation Program have agreed to participate in the negotiation proceedings.

These 10 companies manufacture some of the costliest and most commonly used prescription drugs amongst Medicare beneficiaries. Negotiations between the drug manufacturers and the Centers for Medicare and Medicaid Services (CMS) will proceed through the end of 2023 and into 2024. Any agreed upon prices will be published by CMS by September 1, 2024, and will become effective January 1, 2026.

Resources

• 10 Drug Companies
• HHS Press Release
• Selected Drugs
• CMS Statement
• Medicare Drug Negotiation Webpage

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Mass General Develops New Imaging Technique

Researchers from Mass General Brigham in Somerville, MA and Massachusetts General Hospital in Boston have developed a new imaging technique that distinguishes tumors from normal tissue.

Fluorescence lifetime (FLT) imaging is a technique that combines indocyanine green (ICG), an injectable dye, with high-speed cameras. The researchers noted ICG is cleared by the U.S. Food and Drug Administration for other indications but is not yet cleared for a tumor marking agent.

The imaging technique has been tested on multiple cancer types including liver, brain, tongue, skin, breast, bone, and soft tissue. The initial 60 patients tested with the technique showed a 97% accuracy in differentiating tumor tissue from healthy tissue. The results of the group’s results were published in Nature Biomedical Engineering.

“Our work suggests that the combination of fluorescence lifetime imaging with ICG could improve surgical resections, thereby impacting patient lives,” Anand Kumar, PhD, of Massachusetts General Hospital.

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ACR Updates Appropriateness Criteria

The American College of Radiology (ACR) has released, among other updates, nine new and nine revised topics to their Appropriateness Criteria® (AC).

The ACR AC are evidence-based guidelines to assist referring physicians in making the most appropriate imaging or treatment decisions. The criteria includes a total of 233 diagnostic imaging and interventional radiology topics with more than 1,100 clinical variants and more than 3,000 clinical scenarios. Some new topics of note include Imaging of Invasive Breast Cancer, Preprocedural Planning for Left Atrial Procedures in Atrial Fibrillation, Sepsis, Workup of Pleural Effusion or Pleural Disease and Screening for Abdominal Aortic Aneurysm. Revised topics include Female Breast Cancer Screening, Pretreatment Evaluation and Follow-up of Invasive Cancer of the Cervix, and Management of Uterine Fibroids. Additional information can be found on the ACR website.

Educational Opportunities
Palmetto GBA

• Drugs and Biologicals Webinar – On Demand
• Single-Dose Container & Single Use Package Drug Wastage Modifiers Webinar – November 15, 2023

Noridian

• Modifier 59 Webinar – November 14, 2023
• Drugs & Biologicals – Outpatient Hydration, Infusions, Documentation and Post-Pay Review Webinar – November 21, 2023

First Coast

• Verify your E/M code selection in 2023 Webinar – November 15, 2023
• Incident-to and Fee-for-Time Webinar – On Demand

MLN Fact Sheet

• Complying with Medical Record Documentation Requirements – Updated

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