Trastuzumab-dttb, Biosimilar of Herceptin, Launches on U.S. Market

On April 15, Merck announced the U.S. launch of Ontruzant (trastuzumab-dttb), as a biosimilar of the reference biologic medicine Herceptin. Ontruzant is available in both 150 mg single-dose vials and 420 mg multiple-dose vials, according to the company press release. 

Read company announcement.

4/15/2020 

CMS Issues Guidance on Payer COVID-19 Coverage

On April 11, the Centers for Medicare & Medicaid Services (CMS) released guidance for implementation of the requirement for group health plans and group and individual health insurance to cover both COVID-19 diagnostic testing and certain related items and services provided during a medical visit with no cost sharing. This includes urgent care visits, emergency room visits, and in-person or telehealth visits to the doctor’s office that result in an order for or administration of a COVID-19 test. Covered COVID-19 tests include all FDA-authorized COVID-19 diagnostic tests, COVID-19 diagnostic tests that developers request authorization for on an emergency basis, and COVID-19 diagnostic tests developed in and authorized by states.

The guidance also ensures that COVID-19 antibody testing will be covered. When a COVID-19 antibody test becomes widely available, it could become a key element in fighting the pandemic.

Access the guidance. 

4/13/2020

ASCO Launches COVID-19 Registry

HHS Starts Distribution of $30 Billion in Provider Relief Funds

 

CMS Adds New COVID-19 Workforce Flexibility Waivers

On April 9, the Centers for Medicare & Medicaid Services (CMS) temporarily suspended a number of rules so that hospitals, clinics, and other healthcare facilities can boost their frontline medical staffs during the novel Coronavirus (COVID-19) pandemic.

These changes affect doctors, nurses, and other clinicians nationwide, and focus on reducing supervision and certification requirements so that practitioners can be hired quickly and perform work to the fullest extent of their licenses. The new waivers sharply expand the workforce flexibilities CMS announced on March 30.

Access CMS fact sheet on detailing Blanket Waivers for Healthcare Providers (includes information on the new waivers and those announced previously).

Posted 4/10/2020

FDA Approves Braftovi in Combo with Cetuximab for mCRC with BRAF V600E Mutation

HHS Announces Upcoming Funding to Provide $186 Million for COVID-19 Response

• Supplement an existing cooperative agreement to a number of states and local  identified as having the highest number of reported COVID-19 cases (“hot zones”) and jurisdictions with accelerating or rapidly accelerating COVID-19 cases.

Novartis Announces New C-Code for Adakveo®, Effective April 1

Novartis has announced that, effective April 1, 2020, the Centers for Medicare & Medicaid Services (CMS) has issued a product-specific C-code, C9053 for 100 mg/10 mL (10 mg/mL) solution in a single-dose vial of ADAKVEO® (crizanlizumab-tmca) for IV infusion. The code can be reported in box 44 on the CMS-1450 (UB-04) claim form for the hospital outpatient department.

C-codes are used primarily to report services under the Outpatient Prospective Payment System (OPPS), but may also be recognized by other private and public payer types. Please check with each payer for specific requirements.

Important billing and coding information:

ADAKVEO is supplied as a 100 mg/10 mL (10 mg/mL) single dose vial. See below for coding details:

Please make sure to include C9053 on appropriate claims submission forms for ADAKVEO administered April 1 and later. If you have questions or need further clarification, please contact your Reimbursement Manager or ADAKVEO Support at PANO at 1-800-282-7630.

Posted 3/24/2020

FDA Approves Durvalumab for Extensive-Stage Small Cell Lung Cancer

CMS Expands Accelerated & Advance Payment Program for Medicare Providers & Suppliers

On March 28, the Centers for Medicare & Medicaid Services (CMS) announced it is expanding the Accelerated and Advance Payment Program for all Medicare providers throughout the country during the COVID-19 public health emergency. The payments can be requested by hospitals, doctors, durable medical equipment suppliers, and other Medicare Part A and Part B providers and suppliers.

To qualify for accelerated or advance payments, the provider or supplier must:

• Have billed Medicare for claims within 180 days immediately prior to the date of signature on the provider’s/ supplier’s request form,
• Not be in bankruptcy,
• Not be under active medical review or program integrity investigation, and
• Not have any outstanding delinquent Medicare overpayments.

Medicare will start accepting and processing the Accelerated/Advance Payment Requests immediately. CMS anticipates that the payments will be issued within seven days of the provider’s request. Access CMS fact sheet for more information.

Posted 3/29/2020

ASCO Announces Virtual Annual Meeting

CMS FAQs on Medicare Provider Enrollment Relief in Response to COVID-19

CMS Announces Exceptions & Extensions for Quality Reporting Requirements

CMS Posts Fact Sheet on Coverage for COVID-19 Tests

The Centers for Medicare & Medicaid Services (CMS) will be covering COVID-19 tests, and for those original Medicare there is generally no copay (deductible applies). CMS is also permitting Medicare Advantage plans to waive cost-sharing for these tests. 

CMS has posted a fact sheet to the agency's website to aid Medicare providers with information relating to the pricing of both the CDC and non-CDC COVID-19 tests. Read the fact sheet. 

Visit the CMS "Current Emergencies" webpage for updates on CMS' response to this COVID-19. 

Posted 3/13/2020

Report to the Nation Shows Overall Decline in Cancer Death Rates

The Annual Report to the Nation on the Status of Cancer finds that from 2001 to 2017, deaths from cancer (all sites combined) continued to decline. The report was released on March 12 and is published in the journal, Cancer.

The annual report, which represents the collaborative efforts of the Centers for Disease Control (CDC), the National Cancer Institute (NCI), the American Cancer Society (ACS), and the North American Association of Central Cancer Registries NAACCR), found decreases in the overall cancer death rates in all major racial and ethnic groups and among men, women, adolescents, young adults, and children. From 2012 to 2016 incidence of new cancers (for all cancers combined) held steady for men and increased slightly for women.

Over a four-year period (2013 to 2017), the report found:

Cancer death rates for men declined in 11 of the 19 most prevalent cancers, remained stable in four cancers (including prostate), and increased in four cancers (oral cavity and pharynx; soft tissue including heart, brain, and other nervous system; and pancreas).

Cancer death rates for women decreased in 14 of the 20 most common cancers, including (lung and bronchus, breast, and colorectal), but increased for cancers of the uterus; liver; brain and other nervous system; soft tissue including heart; and pancreas. Rates for cancers of the oral cavity and pharynx remained stable.

A companion report assesses progress on the federal government’s Healthy People 2020 objectives for four leading cancers: lung, prostate, breast cancer in women, and colorectal cancer. The targets for reducing death rates were met for all cancers combined as well as for lung, prostate, female breast, and colorectal cancers overall. However, these decreases were not consistent across all sociodemographic groups. Despite some progress over the past decade, the report points to the continued need to address disparities in cancer screening and in certain risk behaviors.

In addition, the report finds that Healthy People 2020 targets were not met for decreasing adult cigarette smoking; increasing success in smoking cessation; lowering excessive alcohol use; or reducing obesity—behaviors that have been associated with cancer risk.

Posted 3/11/2020

Udenyca Well Prepared to Meet Market Demand

FDA Approves Sarclisa® for Relapsed Refractory Multiple Myeloma

On March, 2, 2020, the U.S. Food and Drug Administration (FDA) approved Sarclisa^® (isatuximab-irfc) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with relapsed refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Sarclisa is expected to be available to patients in the U.S. shortly.

Sarclisa is a monoclonal antibody that binds to the CD38 receptor on multiple myeloma cells.

Sarclisa has Orphan Drug Designation status from the FDA.

Read corporate press release.

Posted 3/2/2020

CMS Issues Proposed Changes to Medicare Advantage & Part D

On Feb. 5, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule and Advance Notice Part II.  

The CY 2021/2022 Medicare Advantage and Part D Proposed Rule (CMS- 4190-P) would:

• require Part D plans to offer real-time drug price comparison tools to beneficiaries starting Jan. 1, 2022, to allow consumers to shop for lower-cost alternative therapies under their prescription drug benefit plan. 


• allow a second, “preferred” specialty tier in Part D with a lower cost sharing amount.


• require Part D plans to disclose the measures they use to evaluate pharmacy performance in their network agreements. This would allow CMS to track and report publicly how plans are measuring and applying pharmacy performance measures.

Download Medicare Advantage and Part D Advance Notice Part II.

Posted 2/6/2020

FDA Approves Avapritinib for GIST Subset

ACS Report Finds Largest One-Year Drop in Cancer Deaths

The American Cancer Society’s annual report on U.S. cancer statistics, released Jan. 8, announced the greatest one-year decline in deaths from cancer since 1930. From 2016 to 2017, overall deaths from cancer dropped 2.2 percent. Between 1991 and 2017, the U.S. has seen the overall cancer death rate drop 29 percent.  

In a statement, lead study author Rebecca Siegel, MPH, attributed the record drop to improved statistics related to lung cancer. While a decrease in smoking rates has contributed to the decline, Siegel also credited recent advances in lung cancer treatment for this year's record drop. These include surgical advances, improved diagnostic screening, as well as advances in radiation therapy and anticancer therapeutics.

The U.S. continues to see increases in new cases of certain cancers including cancers of the kidney, pancreas, liver, and oral cavity and pharynx (among non-Hispanic whites), and melanoma skin cancer.

Read the full report.
Read Facts & Figures 2020.

Posted 1/9/2019