Clinical Practice Newsletters
Clinical Practice Updates
Posted December 6, 2019
Signatera is a personalized, tumor informed circulating tumor DNA (ctDNA) test for molecular residual disease (MRD) assessment and surveillance monitoring. Signatera’s unique assay design is optimized to detect low levels of ctDNA with high sensitivity and specificity earlier than current colorectal cancer (CRC) standard of care. Signatera recently received Medicare draft coverage for certain forms...
Posted July 2, 2019
Recently, the FLASCO Clinical Practice Committee Chairman and Co-Chairmen, sent a letter to FL Blue expressing FLASCO’s support for Gilotrif coverage. Last week Florida Blue provided the following response to FLASCO and we wanted to share this info with all members. “First of all thanks for reaching out to us and sharing feedback from FLASCO. ...
Posted June 10, 2019
The Centers for Medicare and Medicaid Services (“CMS”) announced a final rule permitting Medicare Part B plans, including those administered through Medicare Advantage, to impose step therapy on new starts of Part B drugs. CMS noted that this utilization management tool will “ensure that Medicare beneficiaries pay less overall … for Part B drugs.” CMS...
Posted April 17, 2019
Effective June 1 or October 1, 2019, (based on your contract) UnitedHealthcare will no longer reimburse Current Procedural Terminology (CPT) Consultation Codes 99241 to 99255 when billed by any health care professional or medical practice. For detailed information about the updated policy, please review page 20 of the March 2019 edition of the UnitedHealthcare Network...
Posted March 22, 2019
Genentech is excited to share the news of a new FDA-approved indication. TECENTRIQ, in combination with carboplatin and etoposide, is indicated for the first-line (1L) treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). Please see the attached TECENTRIQ 1L SCLC Day 1 Letter, as well as the TECENTRIQ full Prescribing Information, for...
Posted March 22, 2019
The FDA approved Tecentriq (atezolizumab), in combination with carboplatin and etoposide (chemotherapy), for the initial (first-line) treatment of adults with extensive-stage small lung cancer (ES-SCLC). It is the first new initial treatment option approved by the FDA for people with ES-SCLC in more than 20 years. The Genentech press release including Important Safety Information is...
Posted March 22, 2019
National Comprehensive Cancer Network© (NCCN©) has updated the Clinical Practice Guidelines in Oncology for Colon and Rectal Cancer to include BRAFTOVI® in combination with MEKTOVI® and cetuximab or panitumumab as a Category 2a treatment for patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC), after failure of one to two prior lines of therapy for metastatic disease....
Posted January 12, 2017
NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) and the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Penile Cancer. These NCCN Guidelines® are currently available as Version 1.2017. Primary treatment Tis or Ta disease (PN-1) The second option was revised: “Wide local excision .” The fifth option was...
Posted October 27, 2016
NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) and the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Non-Small Cell Lung Cancer. These NCCN Guidelines® are currently available as Version 2.2017. Metastatic Disease (NSCL-17) Testing results modified for PD-L1: PD-L1 positive and EGFR, ALK, ROS1 negative or unknown Subsequent...
Posted October 14, 2016
On October 14, HHS finalized its policy implementing the Merit-Based Incentive Payment System (MIPS) and the Advanced Alternative Payment Model (APM) incentive payment provisions in the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), collectively referred to as the Quality Payment Program. Accompanying the announcement is a new Quality Payment Program website, which will explain the...
Posted October 13, 2016
CMS has communicated that the ICD-10 flexibilities expire on October 1, 2016. At this time, providers will be required to code to accurately reflect the clinical documentation in as much specificity as possible, as per the required coding guidelines. In addition, effective January 1, 2017, CMS will require the use of the JW modifier on...
Posted October 13, 2016
NDC NUMBER CHANGE Former GlaxoSmithKline (fGSK) Products EFFECTIVE IMMEDIATELY, please note that the current NDC numbers are being replaced by the NEW NDC NUMBERS referenced below: Product Name: ARRANON® (nelarabine) Old NDC #0007-4401-06 New NDC # 0078-0683-06 Package Size: 6 vials x 50 mL Package Strength: 250 mg/50 mL Direct Purchasers: Effective immediately, please use the New...
Posted October 5, 2016
The following is important information regarding a unique C-code that was recently assigned to TECENTRIQ™ (atezolizumab) by the Centers for Medicare & Medicaid Services (CMS). The C-code for TECENTRIQ is C9483 (Injection, atezolizumab, 10 mg). The unique C-code goes into effect on October 1, 2016. Payers may require its use until a permanent J-code is...
Posted October 5, 2016
NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia. These NCCN Guidelines® are currently available as Version 2.2016. The Discussion section has been updated to reflect the changes in the algorithm. (MS-1) *For your reference, the previous update (Version 1.2016) to the NCCN Guidelines for Acute...
Posted September 29, 2016
ASCO is pleased to announce that oncology practices can now complete all of their Physician Quality Reporting System (PQRS) requirements through the Quality Oncology Practice Initiative (QOPI®) platform. All users will be able to use the QOPI system to fulfill the Oncology Measures Group set of seven measures for PQRS reporting. QOPI is free to...
Posted September 29, 2016
NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Genetic/Familial High-Risk Assessment: Colorectal. These NCCN Guidelines® are currently available as Version 2.2016. The Discussion section has been updated to reflect the changes in the algorithm. (MS-1) *For your reference, the previous update (Version 1.2016) to the NCCN Guidelines for...
Posted September 29, 2016
NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) and NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL). These NCCN Guidelines® are currently available as Version 1.2017. · The NCCN Guidelines for CLL/SLL (previously included as part of NCCN Guidelines for Non-Hodgkin’s Lymphomas) have...
Posted September 22, 2016
NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Small Cell Lung Cancer. These NCCN Guidelines® are currently available as Version 2.2017. The discussion section has been updated to reflect the changes in the algorithm. *For your reference, the previous update (Version 1.2017) to the NCCN Guidelines for Small...
Posted September 22, 2016
NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Genetic/Familial High-Risk Assessment: Breast and Ovarian. These NCCN Guidelines® are currently available as Version 1.2017. Breast and Ovarian Cancer Risk Assessment (BR/OV-1) First column, 2nd bullet, “An individual with a breast cancer diagnosis meeting any of the following” For the 4th...
Posted September 22, 2016
Three leading national cancer organizations today issued a joint clinical practice guideline update for physicians treating women with breast cancer who have undergone a mastectomy. The update provides additional considerations for physicians to determine which patients might benefit from postmastectomy radiotherapy (PMRT). “We still don’t have a single, validated formula that can determine who needs...
Posted September 16, 2016
NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Older Adult Oncology. These NCCN Guidelines® are currently available as Version 2.2016. Disease-Specific Issues Related to Age/Central Nervous System Cancers: (OAO-B 8 of 32) The recommendations for adjuvant therapy for newly diagnosed patients with glioblastoma multiforme (GBM) were revised as...
Posted September 16, 2016
On September 13, 2016, the U.S. Food and Drug Administration modified the dosage regimen for nivolumab (Opdivo, Bristol-Myers Squibb Co.) for the currently approved indications for renal cell carcinoma, metastatic melanoma, and non-small cell lung cancer. The currently approved recommended dosage regimens were modified to 240 mg intravenously (IV) every two weeks. The approval modifies the...
Posted September 16, 2016
Billing for the pump services rendered in the Part B setting are billed to PART B Medicare per the “Clarification” from CMS within MLN Matters, SE1609. CMS had “clarified” that prolonged drug and biological infusions using an external pump rendered IN THE PART B SETTING are billed to PART B MEDICARE and not the DME....
Posted September 16, 2016
ASCO has confirmed that CMS is currently working to correct technical errors that occurred when they recently updated national coverage policies regarding certain genetic tests. CMS confirms that steps are being taken to reprocess claims that have been denied. According to CMS, the errors occurred during the mapping process from ICD-9 to ICD-10. During...
Posted September 16, 2016
Amgen announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BLINCYTO®(blinatumomab) to include new data supporting the treatment of pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This indication is approved under accelerated approval, and continued approval may be...
Posted September 16, 2016
Cigna has revised its medical coverage policy for breast cancer screening and will now cover three-dimensional (3D) mammography for routine breast cancer screening. Under its previous policy, the company covered 3D mammography for diagnostic purposes, but not for routine screening. The policy had been based on guidance from the U.S. Preventive Services Task Force...
Posted September 16, 2016
The National Comprehensive Cancer Network® (NCCN®), a Centers for Medicare & Medicaid Services (CMS)-approved provider-led entity for imaging appropriate use criteria (AUC), continues to build its library of AUC and has published NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC™) for eight new cancer types. Launched in June 2016, NCCN Imaging AUC™ currently are available...
Posted September 16, 2016
Amerigen Pharmaceuticals Limited (“Amerigen”) announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company’s Abbreviated New Drug Application (ANDA) for a generic version of Temodar® (temozolomide capsules 5, 20, 100, 140, 180 and 250mg). The product has been launched and is manufactured by Stason Pharmaceuticals, Inc. (“Stason”) in Irvine,...
Posted September 16, 2016
FDA granted accelerated approval to pembrolizumab (KEYTRUDA injection, Merck Sharp & Dohme Corp.) for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. Click here for Merck’s announcement For More FDA Information Click Here Medication Guide Prescribing Information...
Posted September 16, 2016
CVS Health Corp. will add 35 products to its lists of excluded drugs in 2017 and no longer cover some treatments for cancer and diabetes, in an aggressive move to favor lower-priced treatments and target what the company called “hyperinflation” of some other products. The drug benefit manager will remove coverage for Novartis AG’s leukemia...
Posted September 16, 2016
Foundation Medicine has launched a new assay, FoundationACT (Assay for Circulating Tumor DNA), a rigorously validated and highly accurate blood-based circulating tumor DNA (ctDNA) assay that provides patients and oncologists with a new option for comprehensive genomic profiling when a tissue biopsy is not feasible or when tissue is not available. By analyzing cell-free...
Posted September 16, 2016
CMS recently provided additional clarification to MACs and providers regarding reimbursement for prolonged drug and biological infusions that are started in the office or outpatient hospital and are associated with care that is billed incident to a physician service using an external pump. In order for Medicare to pay for a drug or biological, the...
Posted September 16, 2016
AbbVie and Bristol-Myers Squibb Company announced a clinical trial collaboration to evaluate the safety, tolerability and efficacy of AbbVie’s investigational biomarker-specific antibody drug conjugate Rova-T (rovalpituuzumab tesirine) in combination with Bristol-Myers Squibb’s Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) regimen as a treatment for relapsed extensive-stage small cell lung cancer (SCLC). The Phase 1/2...
Posted September 16, 2016
Molecular Test to Guide CML Therapy OK’d FDA clears first quantitative nucleic acid assay for BCR-ABL A molecular diagnostic for measuring BCR-ABL levels in patients with chronic myeloid leukemia (CML) was cleared for marketing Friday, the FDA announced. It’s the first quantitative nucleic acid assay for this purpose to be approved in the U.S., the...
Posted August 11, 2016
Merck is pleased to announce that EMEND for oral suspension is now available. (Click the below image to enlarge) EMEND® is a substance P/neurokinin 1 (NK1) receptor antagonist. EMEND for oral suspension is indicated in combination with other antiemetic agents, in patients 6 months of age and older for prevention of: acute and delayed nausea and...
Posted August 11, 2016
Heron Therapeutics Announces U.S. FDA Approval of SUSTOL® (granisetron) Extended-Release Injection for the Prevention of Chemotherapy-Induced Nausea and Vomiting SUSTOL is the first extended-release 5-HT3 receptor antagonist approved for the prevention of acute and delayed nausea and vomiting associated with both moderately emetogenic chemotherapy and anthracycline and cyclophosphamide combination chemotherapy regimens A standard of care...
Posted August 9, 2016
On August 5, 2016, the U. S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA injection, Merck Sharp & Dohme Corp.) for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. The approval was based on demonstration of a...
Posted August 8, 2016
The Centers for Medicare and Medicaid Services (CMS) has issued two proposed rules to update payment policies and payment rates for services furnished under the Medicare Physician Fee Schedule (PFS) and the Hospital Outpatient Prospective Payment System (OPPS). CMS will be accepting comments on these rules until September 6, 2016. The final rules are expected...
Posted July 21, 2016
An independent, peer-reviewed clinical study published today in Oncotarget entitled “Clinical Benefit of A Precision Medicine Based Approach For Guiding Treatment of Refractory Cancers” provides additional data supporting the clinical utility of the Paradigm PCDx test to significantly help improve outcomes for patients with cancer. This independent study was performed by the Indiana University Health...
Posted July 14, 2016
NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Melanoma. These NCCN Guidelines® are currently available as Version 3.2016. Imaging recommendations were clarified, including the following: Addition of footnote “i”, specifying modalities wherever imaging is mentioned: “Chest/abdominal/pelvic CT with contrast, brain MRI with contrast, and/or FDG PET/CT. Neck CT with...
Posted July 7, 2016
Insys Therapeutics, Inc. (“Insys” or “the Company”) (INSY) today announced that the U.S. Food and Drug Administration (FDA) has approved Insys’ dronabinol oral solution, SyndrosTM, an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol (“THC”). Syndros is approved for use in treating anorexia associated with weight loss in patients...
Posted July 7, 2016
NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Ovarian Cancer. These NCCN Guidelines® are currently available as Version 1.2016. · For patients with a suspicious palpable mass and/or symptoms, the following primary treatment option has been revised: “Patients with bulky stage III/IV who are poor surgical candidates due...
Posted June 28, 2016
NATIONAL COMPREHENSIVE CANCER NETWORK®(NCCN®) STATUS1 NCCN CLINICAL PRACTICE GUIDELINES IN ONCOLOGY (NCCN GUIDELINES®) CATEGORY DESIGNATION1 Rituximab (RITUXAN®) is included in the NCCN Guidelines® with a category 1 designation for first-line maintenance therapy (one 375 mg/m2 dose every 2 months for 2 years) in follicular lymphoma patients initially presenting with high tumor burden1 Note: Category 1 designation is given...
Posted June 14, 2016
As you likely know, CMS has a National Coverage Determination policy outlining when to bill under Medicare Part B vs Part D when using oral anti-emetic therapies. Under these policies, providers should bill under Part B only when specific criteria are met, including that the oral anti-emetics are used “as full replacement for the anti-emetic...
Posted June 14, 2016
The American Society of Clinical Oncology (ASCO) has issued a series of guidelines on the management of all stages of” pancreatic cancer. The “guidelines on the management of potentially curable, locally advanced unresectable, and metastatic pancreatic cancer were published online…in the Journal of Clinical Oncology.”
Posted June 10, 2016
CMS Pushes Modifier -JW Requirement to 2017 Source: Medicare Compliance Watch If CMS’ late April release of a change request requiring reporting of the previously optional modifier -JW (drug amount discarded/not administered to any patient) by July 1 seemed too sudden, the good news is many other providers—and the agency—agreed. Due to stakeholder concerns about...
Posted June 10, 2016
UF Health Cancer Center has several clinical trials in process, below please find information about four trials that are currently accepting participants: ADU-CL-11 A Phase 1/2, Open-Label Safety and Efficacy Evaluation of CRS-207 in Combination With Epacadostat in Adults With Platinum-Resistant Ovarian, Fallopian, or Peritoneal Cancer. https://clinicaltrials.gov/ct2/show/NCT02575807?term=adu-cl-11&rank=1 ARGO A Phase III Randomized Placebo-Controlled Study Evaluating...
Posted June 10, 2016
Source: Modern Healthcare By Virgil Dickson Despite outcry from industry stakeholders, advocates and beneficiaries, the CMS is moving forward with a three-year demonstration in which beneficiaries from five states would need to get prior approval before they get home health services. The demonstration will launch in Florida, Illinois, Massachusetts, Michigan and Texas—states that are all tagged...
Posted June 2, 2016
New NCCN Imaging Appropriate Use Criteria Compendium provides a single access point for all imaging recommendations within the NCCN Guidelines FORT WASHINGTON, PA — The National Comprehensive Cancer Network® (NCCN®) has published the NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC™) to support clinical decision-making around the use of imaging in patients with cancer, helping...
Posted June 2, 2016
The American Society of Clinical Oncology (ASCO) today published an updated framework for assessing the relative value of cancer therapies that have been compared in clinical trials. The framework, published in the Journal of Clinical Oncology, defines value as a combination of clinical benefit, side effects, and improvement in patient symptoms or quality of life in...
Posted May 26, 2016
Posted May 19, 2016
New Clinical Trials Available at FHCI: Ovarian Cancer and peritoneal carcinomatosis: GL-ONC1-015: This is an open-label, non-randomized Phase 1b study evaluating the safety and immunotherapeutic effect of GL-ONC1, an oncolytic vaccinia virus, in women diagnosed with platinum-resistant ovarian cancer and peritoneal carcinomatosis. GL-ONC1 is administered via an intraperitoneal catheter. https://clinicaltrials.gov/ct2/show/NCT02759588?term=GL-ONC1&rank=2 Clinical Trial Profile: Clinical...
Posted May 12, 2016
Source: Medscape New joint guidelines on the management of bladder cancer issued by the American Urological Association (AUA) and the Society of Urologic Oncology (SUO) validate many long-standing practices used in the management of superficial bladder cancer but also affirm the real benefits associated with newer technologies to better visualize bladder tumors. Most notabable among...
Posted April 25, 2016
Medscape reported that the American Society of Clinical Oncology (ASCO) “issued comprehensive clinical guidelines on adjuvant chemotherapy for early breast cancer and targeted adjuvant therapy for HER2-positive breast cancer.” The “guidelines are largely adapted from the 2015 Cancer Care Ontario (CCO) clinical practice guidelines, with some additional guidance from ASCO.” The recommendations were published online in...
Posted April 25, 2016
The Food and Drug Administration issued three draft guidance documents on Friday that answer providers’ and pharmacists’ burning questions about drug compounding standards. The proposed rules clarify the amount of drugs that providers can compound without a prescription, set requirements for health system compounding pharmacies and clarify how large-scale compounding sites known as “outsourcing facilities” may be...
