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