Oncotype DX(R) AR-V7 Nucleus Detect(TM) Test - Favorable Draft LCD

Epic Sciences and Genomic Health Announce Favorable Draft Local Coverage Determination (LCD) on Medicare Coverage for Use of the Oncotype DX(R) AR-V7 Nucleus Detect(TM) Test in Patients with Metastatic Castration-Resistant Prostate Cancer.

Medicare Draft Coverage Supports Clinical Utility of the Oncotype DX AR-V7 Nucleus Detect Test, Providing 25,000 Medicare Patients with Coverage Once LCD Is Finalized Epic Sciences, Inc. (Epic) and Genomic Health, Inc. (Nasdaq: GHDX) announced today that Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses molecular diagnostic technologies, has issued a draft local coverage determination (LCD) for the Oncotype DX® AR-V7 Nucleus Detect™ test. The draft LCD recommends Medicare coverage for use of the test throughout the United States to help determine which patients with metastatic castration-resistant prostate cancer (mCRPC) may benefit from androgen receptor signaling inhibitor (ARSi) therapy and which may benefit from chemotherapy. The Oncotype DX AR-V7 Nucleus Detect test is a circulating tumor cell (CTC)-based, liquid biopsy test that is commercially available in the United States through Epic's partnership with Genomic Health.  


"The Oncotype DX AR-V7 Nucleus Detect test is the first and only predictive and prognostic test in prostate cancer that can identify which patients will no longer benefit from ARSi therapies, such as enzalutamide and abiraterone, and need to switch to chemotherapy or start another type of therapy in order to extend life," said Murali Prahalad, Ph.D., president and CEO of Epic Sciences. "The rapid issuance of the draft LCD recommending Medicare coverage highlights the clinical utility and value of this new test in prolonging survival for men with metastatic castration-resistant prostate cancer." 

LONSURF® Receives New FDA Approval

On February 25, 2019 Taiho Oncology, Inc. announced that the United States Food and Drug Administration (FDA) has approved LONSURF® as a treatment for adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.  

Click Here to read the entire press release.

https://www.taihooncology.com/us/newsroom/press-releases/2019-02-25-LON-PM-US-1213-FDA-Approves-Gastric

 

IMFINZI® Assigned Unique HCPCS Code J9173

AstraZeneca is pleased to announce that IMFINZI® (Durvalumab) injection has been assigned a unique HCPCS code by the Centers for Medicare & Medicaid Services (CMS).

Effective for dates of services on or after January 1, 2019, the following code can be used to identify IMFINZI® (Durvalumab) when billing across settings of care as noted in the Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs available at:


https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-24243.pdf

Each provider is responsible for ensuring all coding is accurate and documented in the medical record based on the condition of the patient. The use of this information does not guarantee reimbursement.  Healthcare providers are encouraged to contact payers to confirm code adoption and approved usage prior to submitting claims. 

AstraZeneca Access 360™ can help with questions you may have about coding and reimbursement. For additional assistance, please contact your Reimbursement Counselor at 1-833-360-4357, Monday through Friday from 8 AM to 8 PM Eastern Time, or visit www.MyAccess360.com.

References: 1. Centers for Medicare & Medicaid Services. Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs. November 2, 2018.

New FDA Approval for KEYTRUDA®

Merck is pleased to announce that KEYTRUDA has been approved by the FDA for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic MCC. 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.

·    PD-L1 diagnostic testing is not required prior to initiating treatment with KEYTRUDA in these patients.

Before prescribing KEYTRUDA® (pembrolizumab), please read the Prescribing Information

The Medication Guide also is available.

New FDA Approval for TECENTRIQ®

Genentech is excited to share the news of a new FDA-approved indication. TECENTRIQ® (atezolizumab), in combination with Avastin® (bevacizumab), paclitaxel, and carboplatin, is now indicated for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (nsqNSCLC) with no EGFR or ALK genomic tumor aberrations.Click Here for the BFRM Quick reference.Click Here for the full prescribing information.

FDA Approves Vitrakvi® (larotrectinib)

FDA Approves Vitrakvi® (larotrectinib), the First Ever TRK Inhibitor, for Patients with Advanced Solid Tumors Harboring an NTRK Gene Fusion1,2 

• First treatment with a tumor-agnostic indication at the time of initial FDA approval

• 75% overall response rate (ORR) (95% CI, 61%, 85%) [22% complete response (CR) and 53% partial response (PR)] across various solid tumors in adults and children (N=55)2

• Adverse events (AE) of any grade observed in 20% or more of patients, regardless of attribution, included increased ALT (45%), increased AST (45%), anemia (42%), fatigue (37%), nausea (29%), dizziness (28%), cough (26%), vomiting (26%), constipation (23%), and diarrhea (22%)2

Vitrakvi will be available in oral capsules as well as a liquid formulation for adults and children.2

Bayer to Provide Comprehensive Value and Access Programs

Bayer is committed to ensuring that patients in the U.S. who are prescribed Vitrakvi are able to access the medication and receive the support they may need. As part of this commitment, Bayer is providing two comprehensive programs, the Vitrakvi Commitment ProgramTM and the TRAK AssistTM patient support program. 

The Vitrakvi Commitment Program will refund the cost of Vitrakvi to payers, patients and third-party organizations paying on behalf of patients, in the event eligible patients do not experience clinical benefit within 90 days of treatment initiation. Eligible patients include those who have tested positive for an NTRK gene fusion, have not received clinical benefit within 90 days of treatment initiation, and received Vitrakvi from an in-network specialty pharmacy.

 

The TRAK AssistTM patient support program provides comprehensive reimbursement support and patient assistance services. For more information and eligibility requirements, please call 1-844-634-TRAK (8725) or www.vitrakvi.com .

Click Here to read the Press Release.

Click Here to read the Prescribing Information. 

New J Code for Rituxan

The Centers for Medicare & Medicaid Services (CMS) has made a change to the RITUXAN® (rituximab) J-code and has assigned a permanent J-code for RITUXAN HYCELA® (rituximab/hyaluronidase human subcutaneous injection). 

Effective January 1, 2019 J-code J9312 will replace J9310 for RITUXAN and the billable units will change from 100 mg to 10 mg. 

Click Here for the RITUXAN AND RITUXAN HYCELA J-Code Flash Card provided by Genentech. 

Apple Health (Medicaid) Provider Alert

What is changing? 

There is no change to the agency’s current process for hospice 5-day notification for Washington Apple Health (Medicaid) clients. 

When does the agency require a completed hospice 5-day notification?

The agency requires a completed hospice 5-day notification form (HCA/Medicaid Hospice Notification, HCA 13-746) when the client is enrolled in hospice and resides in a nursing home, or may be admitted to a nursing home, and is one of the following: 

  • A Medicare client whose Medicaid eligibility is pending or who has not yet applied for Medicaid; or
  • A dual-eligible client (currently enrolled in Medicare and Medicaid). 

Please review the HCA/Medicaid Hospice Notification (HCA 13-746) form for complete and valid information, including current attending physician. The agency will return incomplete or incorrect forms by fax. To download an agency provider form, go to HCA’s Billers and provider’s web page, select Forms & publications.

When does the agency NOT require a completed hospice 5-day notification? 

Do not send an HCA/Medicaid Hospice Notification form to the agency for anyone who is private pay and not enrolled in Washington Apple Health (Medicaid).