August 24, 2021
This Weekly's Hot Topics
  • You have until this Thursday, August 26, to have a voice in insurers step therapy protocols, AB347! California News
 
  • Comments are due September 13, on proposed rule for the Medicare Physician Fee Schedule! CMS News & ASCO News
 
  • Tomorrow, August 25, MOASC LunchTime Series discussing new California law affecting your practice. MOASC News
 
  • FDA amends emergency use authorizations for certain COVID-19 vaccines. Medicare News/Noridian News
MOASC News
We are pleased to announce that the MOASC Program Committee has expanded to include the following physicians:
Anthony Nguyen, MD, UCSD as the new Program Director; and Committee Members:
Dani Castillo, MD (Second Year Fellow – Loma Linda);
Esther Chong, MD (First Year Fellow – Loma Linda);
Yen Cao, MD (Second Year Fellow – UCI);
Munveer Bhangoo, MD, Scripps Health;
Misagh Karimi,MD, City of Hope and
Ashkan Lashkari, MD, Wellness Oncology.
 Save-the-date: Saturday, March 26, 2022 – Annual Oncology Summit.

MOASC wishes to congratulate MOASC Charter Member, N. Simon Tchekmedyian, MD and Pacific Shores Medical Group in joining the City of Hope (a MOASC Institution Member). In joining the City of Hope family, Pacific Shores Medical Group, a world-renowned independent research and treatment center for cancer, will enable greater access to oncology & hematology care for patients from Orange County, CA, as well.
MOASC members are experiencing issues with Blue Shield of CA – Commercial Plans requiring White Bagging of drugs. MOASC is trying to determine if this is just a few offices or across Southern California. If YOU have been experiencing any White Bagging issues with Blue Shield of California, please contact the MOASC Office at moasc@moasc.org. Thank you.
 
CBCC Global is excited to pursue a clinical trial opportunity with MOASC member sites. The study details are below and CBCC Global looks forward to hearing from the interested Investigators/sites. The budget per patient completing the study as per protocol is up to USD. 40,000.00
Briefly, the study details are as mentioned below,
  1. Objective: To compare and evaluate the single dose bioavailability of paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/vial by Sponsor Ltd., India (test product) to ABRAXANE® for injectable suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) 100 mg/vial by Celgene Corporation, USA (reference product)
  2. Patient population: Breast cancer patients after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.
  3. No. of Patients: 32
  4. Drug administration: 30 min infusion Q3W under Yellow monochromatic light (Yellow monochromatic bulbs may be arranged by CRO if needed)
  5. No. of Cycles: 4
  6. Housing: In-house (up to 24 hour post dose) or Outpatient study (up to 12 hour on the day of infusion); hotel accommodation can be provided to the patients who stay away from the study site.
  7. PK sample schedule: 4.0 mL each will be collected at 0.00 (pre-dose), 0.167 (10 min), 0.333 (20 min), 0.500 (30 min), 0.583 (35 min), 0.750 (45 min), 1.000, 1.500, 2.000, 2.500, 3.000, 4.000, 6.000, 8.000, 12.000, 24.000, 36.000, 48.000, 72.000 and 96.000 hours under yellow monochromatic light. 
Please let me know for further requirements if any. We look forward to hearing from you.
Thank you,
Jayadev Sureddi
Director- Clinical Operations
CBCC Global Research
6501 Truxtun Ave.,
Bakersfield, CA 93309
Ph. (661) 616-6453
Cell. (661) 201-2536
MOASC Programs - Save the Dates - All Times are Pacific
August 25th at 12:30pm, MOASC LunchTime Series presents a zoom meeting with Bradley Behrendt, Financial Consultant discussing new California law requirements that force business with more than 5 employees to provide a qualified health plan to their employees. 
Cedars Sinai invites GI Nurses and Interdisciplinary Professionals to their 2021 Annual Seminar for GI Nurses and Associates on September 25, 2021.
California News
Assemblymember Dr. Joaquin Arambula (D-Fresno) has authored Assembly Bill (AB) 347, which would create a more transparent and standardized process in step therapy protocols. The bill would require health insurers to formulate a standard exception process, require an insurer to send an approval or denial request, and create clinical peer-to-peer review appeals by specialists working in similar medical fields. The Senate Committee in Appropriations hearing was last week on August 16. The final committee vote will be this Thursday, August 26! Read the following article to see how you can help!
Below please find social media posts that your organization may share regarding AB347.  The Arthritis Foundation is taking the lead in advocacy and continues to seek out health care providers to share supportive quotes about the importance of the clinical peer piece of AB 347.
Please reach out to Silvina Martinez smartinez@arthritis.org or Jennifer Wagner jwagner@arthritis.org if you or your organization has connections with Senator Portantino or if you have a connection with a health care provider who is interested in helping! The Senator is the key decision maker on whether this bill moves out of committee. Please use the samples below to advance this important cause.
Sample Social Media samples
Symptoms & medication reactions can be avoided with new and innovative medicines. Additional guidelines and processes would ensure that patients receive treatments without unnecessary and dangerous delays. #steptherapy #ab347 https://bit.ly/375vTA3
 
Insurers need transparency, standardization in step therapy by patient advocate, Chloe Hubbard. @Capitol_Weekly #steptherapy #ab347 https://bit.ly/375vTA3
Medicare News 
Noridian News
Vaccinate Your Patients - Help protect your patients from COVID-19. Medicare covers the COVID-19 vaccine administration. There’s no cost to your Medicare patient for the vaccine and its administration.
The FDA amended the emergency use authorizations (EUAs) for both the Pfizer BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine to allow for an additional dose in certain immunocompromised people. Effective August 12, 2021, CMS will pay to administer additional doses of COVID-19 vaccines consistent with the FDA EUAs using CPT code 0003A (Pfizer) and 0013A (Moderna). Noridian will pay approximately $40 each. Noridian will hold and then process all claims with these codes after they complete claims system updates, no later than August 27, 2021.
Noridian Programs
August 25, Provider Enrollment: PECOS Overview. Learn the advantages of PECOS. How it saves you time, tracks associates and applications. This session includes the PECOS questionnaire and submitting the e- signatures.
August 25, Beneficiary Forms for Medicare Part A and Part B. This webinar is intended for Medicare Part A/B Providers and will include: • Beneficiary Notices Initiative (BNI) • Medicare Outpatient Observation Notice (MOON) • Important Message from Medicare (IM) • Detailed Notice of Discharge (DND) • Hospital-Issued Notice of Noncoverage (HINN) • Advance Beneficiary Notice of Noncoverage (ABN).
August 31, Noridian Medicare Portal (NMP) Claim Denial Details and Appeals. This webinar is intended for Medicare Part A/B Providers and will include: • Claim Status • Additional Documentation Request (ADR) • Reopenings • Appeals • Message Center • Resources
CMS News

The Centers for Medicare and Medicaid Services (CMS) released a proposed rule on the Medicare Physician Fee Schedule (PFS) updates for calendar year (CY) 2022. The PFS Proposed Rule announces planned policies for the sixth and future years of the Quality Payment Program (QPP) established by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Comments are due September 13, 2021 by 2:00pm PDT/5:00 pm EDT
National News
Last week public health and medical experts from the U.S. Department of Health and Human Services (HHS) released a joint statement on the Administration’s plan for COVID-19 booster shots for the American people.
Ask your Congressional representatives to cosponsor H.R. 3258, the Timely Access to Cancer Treatment Act of 2021. The Timely Access to Cancer Treatment Act of 2021 (TACT Act) was recently introduced by Representatives Terri Sewell (D-AL) and Gus Bilirakis (R-FL).
The TACT Act requires PBMs and insurers to ensure patients with cancer can receive their prescribed medication within 72 hours – failing that, the patient will be allowed to seek out medication from any professionally licensed source of their choosing. Contact your Congressional offices as soon as possible and ask them to cosponsor H.R. 3258! Don’t know who your representative or senator is? Click here to access our list of key staff or email Deandra Dickson for help.
Affiliate Association News
ACCC News
The ACCC has partnered with The PROVE Center at the Brigham & Women’s Hospital (BWH) for a proposed research study, Bridging the Gap in Breast Cancer Disparities: Implementing Patient-Reported Outcomes in Data Collection Across Cancer Centers. This proposed study aims to utilize health information technology (HIT) to engage diverse and underserved patients and the community cancer centers that serve them to increase patient-reported outcome (PRO) measurement and address disparities in cancer care. The HIT platform for this study will be the IMPROVE Breast Cancer Care app developed and piloted at The PROVE Center at BWH to collect PROs and provide immediate feedback and tailored resources to patients. For any questions, please contact Janelle Schrag, MPH, Assistant Director, Research Programs, Provider Education, jschrag@accc-cancer.org. Apply by Friday, August 27, 2021 to be considered.
The Association of Community Cancer Centers (ACCC) today announced the launch of a new content series for cancer care practitioners: Returning to Practice in the COVID-19 Era. The series is designed to help cancer care professionals navigate the uncertain environment of caring for patients with cancer and immunocompromised patients during the continued threat of a global pandemic, while vaccination rates remain alarmingly low and masking and social distancing mandates change daily. The project teaches multidisciplinary cancer care teams what to anticipate as they resume pre-pandemic services, specifically for patients with hematologic malignancies including chronic lymphocytic leukemia (CLL), acute myeloid leukemia (AML), and multiple myeloma (MM).
ASH News
ASH is committed to educating its members on how to become effective advocates for hematology research and practice, by hosting a new series titled the ASH Advocacy Webinar Series. Registration is free and open to all interested. The series will be composed of four, hour-long webinars covering the following topics: Federal Agencies and Hematology: An inside look at the NIH, CDC, and FDA on 9/27; Working with Advocacy Groups and Coalitions: How to Amplify Your Voice in Washington on 10/4. All programs are 1-2pm PDT (4-5pm EDT).
ASCO News

ASCO released an in-depth analysis of what the impact of the 2022 Medicare Physician Fee Schedule (PFS) and Hospital Outpatient Prospective Payment System (OPPS) proposed rules—as well as pending sequestration cuts—could have on cancer care beginning January 1, 2022. The analysis was performed using a PracticeNET dataset of 35 physician and hospital-based practices in the United States. ASCO’s modeling of the PFS proposal showed slightly larger reimbursement cuts, compared to Centers for Medicare & Medicaid Services (CMS) estimates, for both the hematology/oncology specialty (an ASCO-estimated 2.9% decrease vs. CMS-estimated 2% decrease) and for radiation oncology (an ASCO-estimated 6.4% cut vs. a CMS-estimated 5% cut). The difference between the ASCO and CMS estimates may be due to the higher proportion of private practices in the PracticeNET dataset. 
Industry News
Bristol-Myers Squibb Co. announced their FDA approval of Nivolumab (Opdivo) for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection. This is the first FDA approval for adjuvant treatment of patients with high-risk urothelial carcinoma.
Incyte Corp. strives to provide assistance to physicians and patient education through their patient webinar programs. Please share this invitation with your patients and their caregivers who have been diagnosed with myeloproliferative neoplasms (MPN), including Polycythemia Vera, Essential thrombocythemia and Myelofibrosis. They will hear from Incyte Oncology Clinical Nurse Educators about MPNs. There are four live webinars, September 1,2,21 & 22 to choose from. Thank you.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANTTM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations. The initial data showed anti-tumor activity in patients with METex14 mutations and a safety profile consistent with reported experience at the approved CHRYSALIS Phase 2 dose (RYBREVANTTM 1050 mg [<80 kg] / 1400 mg [≥80 kg]).
Merck announced that the FDA approved WELIREG, an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. The recommended dose of WELIREG (40 mg tablets) is 120 mg once daily until disease progression or unacceptance toxicity. The approval is based on results from the open-label Study 004 trial (N=61), where the major efficacy endpoint was overall response rate (ORR) in patients with VHL-associated RCC.
The Medical Oncology Association of Southern California (MOASC) is a leading oncology society that advances and protects the ability of cancer patients to obtain, and the ability of the oncology physicians to provide, optimal cancer care. The material contained in the California Oncology Weekly is intended as general information for MOASC members. Because diagnostic, treatment, contracting, coding, and billing decisions should be made on a case-by-case basis, any such information contained in the California Oncology Weekly may not apply in any given situation. Members are encouraged to contact their own consultants or advisors to obtain specific advice on matters relating to contracting, coding, and billing. The information contained in California Oncology Weekly should not be used as a substitute for such advice. This publication provides a summary of regulations affecting oncology and its business practices. Reading this newsletter does not substitute for understanding regulations and verifying the validity of every claim. This information is time-sensitive and is subject to change. MOASC accepts no liability for any statements or articles herein. CPT codes are owned and trademarked by the American Medical Association. All Rights Reserved.