Oncology News & Updates

FDA Approvals

On November 15, 2023, the Food and Drug Administration approved repotrectinib (Augtyro, Bristol-Myers Squibb Company) for locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). This is the first FDA approval that includes patients with ROS1-positive NSCLC who have previously received a ROS1 tyrosine kinase inhibitor (TKI), in addition to patients who are TKI naïve.

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On November 16, 2023, the Food and Drug Administration approved enzalutamide (Xtandi, Astellas Pharma US, Inc.) for non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR).

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On November 16, 2023, the Food and Drug Administration approved capivasertib (Truqap, AstraZeneca Pharmaceuticals) with fulvestrant for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, as detected by an FDA-approved test, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. FDA also approved the FoundationOne®CDx assay as a companion diagnostic device to identify patients with breast cancer for treatment with capivasertib with fulvestrant.

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On December 1, 2023, the Food and Drug Administration granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

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On December 14, 2023, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) for patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).

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On December 15, 2023, the Food and Drug Administration (FDA) approved enfortumab vedotin-ejfv (Padcev, Astellas Pharma) in combination with pembrolizumab (Keytruda, Merck) for patients with locally advanced or metastatic urothelial cancer (la/mUC). FDA previously granted accelerated approval to this combination for patients with la/mUC who are ineligible for cisplatin-containing chemotherapy.

Full prescribing information for Padcev and Keytruda will be posted here.

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Merck would like to inform you that the FDA has approved KEYTRUDA® (pembrolizumab) Injection 100 mg, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.

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Merck would like to inform you that the FDA has approved KEYTRUDA® (pembrolizumab) Injection 100 mg, in combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC).

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Updated indication treatment for patients with recurrent locally advanced or Metastatic Merkel Cell Carcinoma (MCC). KEYTRUDA® (pembrolizumab) Injection 100 mg is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic MCC.

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The U.S. Food and Drug Administration has approved of PADCEV + pembrolizumab for the treatment of adult patients with locally advanced or mUC based on data from the EV-302 trial. This latest approval expands the indication of PADCEV + pembrolizumab and the patient population that may benefit from this treatment.

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National Guideline Updates

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®), for Prevention and Treatment of Cancer Related Infections. These NCCN Guidelines® are currently available as Version 2.2023.

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This notification is being provided to update you on the official withdrawal of EXKIVITY (mobocertinib), which will occur no later than March 2024, with the specific date still to be determined by the US Food and Drug Administration (FDA) based on review of ongoing operational activities related to the withdrawal. Until withdrawal, EXKIVITY continues to be available to prescribe for patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive locally advanced or metastatic non-small cell lung cancer (mNSCLC) whose disease has progressed on or after platinum-based chemotherapy.

 

Patients receiving EXKIVITY will be able to maintain access following withdrawal from the market through a compassionate use program that is being established. After withdrawal, the compassionate use program will provide prescribed patients access to EXKIVITY free of charge for as long as they are benefiting from the medication, as assessed by their HCP. However, EXKIVITY will no longer be available for new patients following withdrawal from the market, which will occur no later than March 2024.

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Register for Clinical Care Solutions webinar, “A Treatment Option for ROS1+ NSCLC”, on Wednesday January 17, 2024 from 12:15 – 12:45 pm ET. Join a leading oncology expert to discuss recent clinical data for the application of an emerging treatment for ROS1-positive NSCLC.​

View the invitation at the link below for more information.

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CMS & Noridian Updates

Medicare Jurisdiction E Part B Updates

• Payment of Codes for Chemotherapy Administration and Nonchemotherapy Injections and Infusions CR13468
  • CR 13468 provides clarification regarding the Medicare guidance/policy that relates to CPT codes 96401-96549. Read the complete update here.
• January 2024 Quarterly ASP Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files CR13380
  • CR 13380 supplies the contractors with the ASP and NOC drug pricing files.

State and National Legislative & Regulatory Issues

Read the latest CMA practice resources newsletter.

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Northern California Clinical Trials

List of newly available adjuvant trials for patients with high-risk melanoma at UCSF:

 

1. A Clinical Study of V940 Plus Pembrolizumab in People With High-Risk Melanoma (V940-001). This is a personalized neoantigen mRNA vaccine trial that randomizes patients with stage IIB-IV melanoma s/p surgery to either the vaccine and pembro or pembro alone in a 2:1 ratio. Data from a smaller trial has been presented at ASCO and ESMO recently showing benefit.
2. Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010). Vibostolimab is a TIGIT antibody and in a prior trial appeared beneficial in the neoadjuvant setting.
3. Adjuvant Fianlimab plus Cemiplimab versus cemiplimab in Resected High-Risk Stage II-IV Melanoma. Fianlimab is a Lag-3 antibody and this trial randomizes patients to this combination versus cemiplimab alone (PD-1 antibody).

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FDA Approvals

Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo®(nivolumab) was approved by the U.S. Food and Drug Administration (FDA) for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stage IIB or IIC melanoma, expanding upon the existing adjuvant indication for Opdivo and further reinforcing the company’s legacy of providing treatment options for melanoma patients. The approval is based on the Phase 3 CheckMate -76K trial, which compared Opdivo (n=526) to placebo (n=264).

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US Food and Drug Administration has approved FRUZAQLA™ (fruquintinib), an oral therapy for adult patients with previously treated metastatic colorectal cancer (mCRC).

FRUZAQLA is a kinase inhibitor indicated for the treatment of adult patients with mCRC who have been previously treated with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy.

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On November 7, 2023, the Food and Drug Administration revised the existing indication of pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. This updated indication, which remains approved under accelerated approval regulations, restricts its use to patients whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA-approved test.

The FDA also approved the Agilent PD-L1 IHC 22C3 pharmDx as a companion diagnostic device to select patients with gastric or GEJ adenocarcinoma whose tumors express PD-L1 (CPS ≥ 1).

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On November 8, 2023, the Food and Drug Administration approved fruquintinib (Fruzaqla, Takeda Pharmaceuticals, Inc.) for adult patients with metastatic colorectal cancer (mCRC) who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.

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On November 16, 2023, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.

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NCCN Updates

An option for the first-line treatment of certain adult patients with locally advanced or metastatic urothelial carcinoma who are cisplatin-ineligible recommended by the National Comprehensive Cancer Network® (NCCN®)

KEYTRUDA® (pembrolizumab) Injection 100 mg, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

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NCCN Guidelines Updated for Non-Small Cell Lung Cancer

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) and the NCCN Drugs and Biologics Compendium (NCCN Compendium®) for Non-Small Cell Lung Cancer. These NCCN Guidelines® are currently available as Version 5.2023.

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NCCN Guidelines Updated

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) and the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Colon Cancer. These NCCN Guidelines® are currently available as Version 4.2023.

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Coding and Reimbursement Updates

View the November E-Reimbursement Newsletter

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BREAKING E-Reimbursement News: Q1 Mega HCPCS, Split Visits, SDoH, and Payer Shenanigans 11-30-2024

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Treatment for Patients With Resectable (Tumors ≥4 cm or Node Positive) Non–Small Cell Lung Cancer (NSCLC) KEYTRUDA® (pembrolizumab) Injection 100 mg is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

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State and National Legislative & Regulatory Issues

ASCO Research Statement Recommends Cancer Clinical Trials Provide A Way To Assess Ovarian Toxicity

Healio (10/3, Shinkle) reports, “ASCO released a research statement outlining new recommendations regarding the appropriate assessment of ovarian toxicity in cancer clinical trials.” The new “statement’s three key recommendations aim to provide researchers with a way to measure ovarian toxicity in cancer clinical trials while also encouraging data acquisition.” According to Healio, “The goal is to provide patients and clinicians with information regarding potential long-term effects of certain treatments.” The statement was published in The Lancet Oncology.

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FDA Approvals

On October 16, 2023, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent pembrolizumab as post-surgical adjuvant treatment for resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).

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On October 20, 2023, the Food and Drug Administration granted accelerated approval to entrectinib (Rozlytrek, Genentech Inc.) for pediatric patients older than 1 month with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory standard therapy. In August 2019, FDA granted accelerated approval to entrectinib for pediatric patients 12 years of age and older for this indication.

FDA also approved a new oral pellet formulation for entrectinib, and the prescribing information now includes instructions for making an oral suspension from the capsules.

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On October 27, 2023, the Food and Drug Administration approved toripalimab-tpzi (LOQTORZ, Coherus BioSciences, Inc.) with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (NPC). FDA also approved toripalimab-tpzi as a single agent for adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy.

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Coding and Reimbursement Updates

View the August E-Reimbursement Newsletter

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The Centers for Medicare & Medicaid Services Office of Minority Health (CMS OMH) released a new Z code infographic entitled: Improving the Collection of Social Determinants of Health (SDOH) Data with ICD-10-CM Z Codes (2023). This resource aims to assist providers with understanding and using Z codes to improve the quality and collection of health equity data.

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FDA Approvals

On September 14, 2023, the Food and Drug Administration (FDA) approved updated labeling for temozolomide (Temodar, Merck) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date.

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Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Reblozyl^® (luspatercept-aamt) for the treatment of anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions.

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On September 26, 2023, the Food and Drug Administration approved bosutinib (Bosulif, Pfizer) for pediatric patients 1 year of age and older with chronic phase (CP) Ph+ chronic myelogenous leukemia (CML) that is newly diagnosed (ND) or resistant or intolerant (R/I) to prior therapy. The FDA also approved a new capsule dosage form available in strengths of 50 mg and 100 mg.

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Are you interested in learning about and staying up to date with VENCLEXTA?

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FDA Approvals

On July 31, 2023, the Food and Drug Administration approved dostarlimab-gxly (Jemperli, GlaxoSmithKline) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for primary advanced or recurrent endometrial cancer (EC) that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H).

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Pfizer Oncology is proud to announce the FDA approval of ELREXFIO™ (elranatamab-bcmm).

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Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. announced on August 2, 2023 that the FDA has approved LONSURF® (trifluridine/tipiracil) as a single agent or in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.

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Coding and Reimbursement Updates

View the August E-Reimbursement Newsletter

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For the first time, the law provides Medicare the ability to directly negotiate the prices of certain high expenditure, single source drugs without generic or biosimilar competition. These 10 drugs are covered under Medicare Part D and selected for negotiation for initial price applicability year 2026, based on total gross covered prescription drug costs under Medicare Part D and other criteria as required by the IRA (Inflation Reduction Act).

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State and National Legislative & Regulatory Issues

The American Society of Clinical Oncology (ASCO) recently released a position statement on white bagging. The statement was developed in close consultation with leading ASCO volunteers and affirms ASCO’s opposition to the mandated use of white bagging.

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NCCN Updates

NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates®) for Head and Neck Cancers to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Head and Neck Cancers v2.2023.

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates®) for Endometrial Carcinoma to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Uterine Neoplasms v2.2023.

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NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) and the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for B-Cell Lymphomas. These NCCN Guidelines® are currently available as Version 5.2023.

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NCCN has published updates to the NCCN Chemotherapy Order Templates (NCCN Templates®) for Gastrointestinal Stromal Tumors (GIST) to reflect the currently published NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Gastrointestinal Stromal Tumors (GIST) v1.2023.

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FDA Approvals

On July 20, 2023, the Food and Drug Administration approved quizartinib (Vanflyta, Daiichi Sankyo, Inc.) with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive, as detected by an FDA-approved test.

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Updated KEYTRUDA® Indication
KEYTRUDA® (pembrolizumab) Injection 100 mg is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

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Genentech is pleased to announce the US Food and Drug Administration (FDA) approval of COLUMVI™ (glofitamab-gxbm), a T-cell engaging bispecific antibody. COLUMVI (glofitamab-gxbm) is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL).

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Coding and Reimbursement Updates

View the July E-Reimbursement Newsletter

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On July 13, 2023, the Centers for Medicare & Medicaid Services (CMS) released its proposed rule for the 2024 Medicare Physician Fee Schedule (PFS) and updates to the Quality Payment Program (QPP). The agency also released the 2024 Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed rule.

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CMS & Noridian Updates

Incident to Billing Webinar – August 24, 2023
The Noridian Provider Outreach and Education (POE) staff is hosting the Incident to Billing webinar on 08/24/2023 at 1:00 PM PT.
This event includes: Incident to; Overview and Coverage; Supervision; Nonphysician Practitioners; Split/Shared; Substitute Providers

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Billing and Coding: MolDX: Germline Testing for use of PARP inhibitors (A55294) – R10 – Effective July 28, 2022
This coverage article has been revised and published for notice under contract numbers: 01112 (NCA), 01182 (SCA), 01212 (HI and Territories), and 01312 (NV).

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MolDX: Genetic Testing for BCR-ABL Negative Myeloproliferative Disease (L36180) – R12 – Effective July 06, 2023
This Local Coverage Determination (LCD) has been revised under contractor numbers: 01112 (NCA), 01182 (SCA), 01212 (AS, GU, HI, and NMI), and 01312 (NV).

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Billing and Coding: MolDX: Minimal Residual Disease Testing for Solid Tumor Cancers (A58454) – R4 – Effective July 06, 2023
This coverage article has been revised and published for notice under contract numbers: 01112 (NCA), 01182 (SCA), 01212 (HI and Territories), and 01312 (NV).

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Billing and Coding: MolDX: Inivata™, InVisionFirst®, Liquid Biopsy for Patients with Lung Cancer (A57664) – R2 – Effective July 01, 2023
This coverage article has been revised and published for notice under contract numbers: 01112 (NCA), 01182 (SCA), 01212 (HI and Territories), and 01312 (NV).

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AstraZeneca is pleased to announce that IMJUDO® (tremelimumab-actl) has been assigned a unique Healthcare Common Procedure Coding System (HCPCS) code and Average Sales Price (ASP) by the Centers for Medicare & Medicaid Services (CMS).

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State and National Legislative & Regulatory Issues

California Supreme Court rules CMA can sue Aetna Health under Unfair Competition Law
The California Medical Association (CMA) has achieved a significant victory for providers, consumers and public interest advocates in the case of California Medical Association v. Aetna Health of California Inc. The California Supreme Court ruled unanimously in favor of CMA, confirming the organization’s legal standing to sue Aetna Health for alleged violations of the Unfair Competition Law.

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FDA Approvals

On June 15, 2023, the Food and Drug Administration granted accelerated approval to glofitamab-gxbm (Columvi, Genentech, Inc.) for relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy.

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PADCEV® (enfortumab vedotin-ejfv) is now approved with an updated indication in combination with pembrolizumab. On April 3, 2023, PADCEV’s indication was expanded based on data from the open-label, multi-cohort, EV-103 trial that evaluated PADCEV in combination with pembrolizumab.

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KEYTRUDA® (pembrolizumab) Injection 100 mg, as a single agent, is indicated for adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage IB (T2a ≥4 cm), II, or IIIA non–small cell lung cancer (NSCLC).

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The US Food and Drug Administration (FDA) has approved a new indication for LYNPARZA® (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

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On June 20, 2023, the Food and Drug Administration approved talazoparib (Talzenna, Pfizer, Inc.) with enzalutamide for homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

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Industry Update

New data from the ADAURA trial regarding TAGRISSO® (osimertinib) has been released. The ADAURA trial is an ongoing study of TAGRISSO as adjuvant therapy after tumor resection in adult patients with completely resected Stage IB-IIIA EGFRm (exon 19 deletions or exon 21 L858R mutations) non-small cell lung cancer (NSCLC).

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Coding and Reimbursement Updates

ImmunoGen informs ANCO of a permanent ELAHERE Healthcare Common Procedure Coding System (HCPCS) J-code Effective July 1, 20231

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ANCO and MOASC STATEMENT ON CANCER CARE DRUG SHORTAGE

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FDA Approvals

Genentech is pleased to announce the US Food and Drug Administration (FDA) approval of POLIVYĒį (polatuzumab vedotin-piiq) in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index score of 2 or greater.

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The Food and Drug Administration granted approval to epcoritamab-bysp (EPKINLY, Genmab) as the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B cell lymphoma, after two or more lines of systemic therapy.

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The Food and Drug Administration approved olaparib (Lynparza, AstraZeneca Pharmaceuticals LP) with abiraterone and prednisone (or prednisolone) for adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved companion diagnostic test.

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Coding and Reimbursement Updates

On May 1, the Center for Medicare & Medicaid Innovation (CMMI) updated its information and calculations relative to the forthcoming (July 1) Enhancing Oncology Model (EOM). This communication describes updates to the EOM payment methodology, specifically concerning the calculation of episode expenditures for performance period episodes.

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View the May E-Reimbursement Newsletter

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CMS & Noridian Updates

MolDX: Molecular Diagnostic Tests (MDT) (L35160) – R16 – Effective May 04, 2023
This Local Coverage Determination (LCD) has been revised under contractor numbers: 01112 (NCA), 01182 (SCA), 01212 (AS, GU, HI, and NMI), and 01312 (NV).

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Top Denials and Solutions – Q2 Webinar – June 19, 2023
This event includes: Claim Denials, Electonic Data Interchange (EDI), Medical Necessity, Medicare Secondary Payer, Duplicate claims, Medical Review

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State and National Legislative & Regulatory Issues

Late stage cancer rates could rise if ACA ruling stands, experts worry
A federal judge’s recent ruling on the Affordable Care Act means that patients would have to pay for some cancer screenings that are currently free—a ruling that, if it holds, could make the potentially life-saving tests unaffordable for many, experts say.

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President Biden Prioritizes Cancer Research, Access to Care in FY 2024 Budget Proposal
The proposal allocates $48.3 billion for the National Institutes of Health (NIH)—an $811 million increase compared to FY 2023; $7.8 billion for the National Cancer Institute (NCI)—a $500 million increase compared to FY 2023; and $2.5 billion for the Advanced Research Projects Agency for Health (ARPA-H)—a $1 billion increase compared to FY 2023. The request also specifically allocates $1 billion for the Cancer Moonshot initiative.

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CMS & Noridian Updates

Hospital In-Patient, Long-Term Care Proposed Rule Aims to Advance Equity, Support Underserved Communities
On April 10, 2023, the Centers for Medicare & Medicaid Services (CMS) issued the fiscal year (FY) 2024 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) proposed rule.

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On April 5, 2023, the Centers for Medicare & Medicaid Services (CMS) released the 2024 Medicare Advantage and Part D Final Rule, which will revise regulations governing Medicare Advantage (MA), the Medicare Prescription Drug Benefit (Part D), Medicare cost plans, and Programs of All-Inclusive Care for the Elderly (PACE). The rule makes changes related to prior authorization, health equity, marketing and communications, and other areas.

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CMS Proposes Policies to Improve Patient Safety and Promote Health Equity

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Reduced Beneficiary Coinsurance for 20 Part B Drugs in Effect April 1; Includes Cancer Drugs
On January 1, a provision of the Inflation Reduction Act (IRA) went into effect requiring drug companies to pay rebates to Medicare when prescription drug prices increase faster than the rate of inflation for certain drugs given to people enrolled in the program. The provision also provides for lower Medicare Part B beneficiary cost sharing on such drugs beginning April 1, 2023.

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FDA Approvals

31 Patient and Provider Groups Warn that Mifepristone Ruling Threatens All FDA-approved Drugs

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Coding and Reimbursement Updates

The California Medical Association (CMA) has submitted a letter in strong opposition to Cigna’s decision to re-release its costly, burdensome modifier 25 policy. The policy – Modifier 25-Significant, Separately Identifiable Evaluation and Management Service by the Same Physician on the Same Day of the Procedure or Other Service – will require the submission of medical records with all Evaluation and Management (E/M) claims with CPT 99212-99215 and modifier 25 when a minor procedure is billed. It is scheduled to become effective nationwide on May 25, 2023.

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