Oncology News & Updates

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.

Learn More

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).

Learn More

 
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.

Learn More

 
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.

Learn More

Coding and Reimbursement Updates

View the August E-Reimbursement Newsletter

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

Other

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

Learn More

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).

Learn More

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

Learn More

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.

Learn More

Coding and Reimbursement Updates

View the August E-Reimbursement Newsletter

Learn More

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).

Learn More

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.

Learn More

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