Oncology News & Updates

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.

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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).

Learn More

Coding and Reimbursement Updates

View the July E-Reimbursement Newsletter

Learn More

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.

Learn More

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

Learn More

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).

Learn More

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).

Learn More

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).

Learn More

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).

Learn More

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).

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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).

Learn More

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.

Learn More

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).

Learn More

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).

Learn More

Coding and Reimbursement Updates

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

Learn More

ANCO and MOASC STATEMENT ON CANCER CARE DRUG SHORTAGE

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

View the May E-Reimbursement Newsletter

Learn More

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).

Learn More

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

Learn More

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.

Learn More

 
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.

Learn More

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.

Learn More

 
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.

Learn More

 
CMS Proposes Policies to Improve Patient Safety and Promote Health Equity

Learn More

 
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.

Learn More

FDA Approvals

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

Learn More

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.

Learn More