Knowledge Base Article

This week we highlight key updates spanning from April 13th through April 19th, 2021.

April 13, 2021: CDC Health Alert: Cases of Cerebral Venous Sinus Thrombosis with Thrombocytopenia after Johnson & Johnson COVID-19 Vaccination

The CDC issued an official Health Alert relaying information about six cases of cerebral venous sinus thrombosis (CVST) in the U.S. after receiving the Johnson & Johnson COVID-19 vaccine. All six cases were women aged 18 – 48 years and the lag time from vaccination to onset of symptoms ranged from 6 – 13 days. Five of the six women had an initial presenting symptom of a headache. One woman died.

The CDC indicated they would convene an emergency meeting of the Advisory Committee on Immunization Practices (ACIP) on April 14th… “until this process is complete, CDC and FDA are recommending a pause in the J&J COVID-19 vaccine out of an abundance of caution.”

Recommendations for Clinicians, Public Health, and the general public are also included in this Alert.

April 13, 2021: New Legal Guidance & Resources to Ensure Expansion of Access to COVID-19 Vaccines

HHS issued a Press Release announcing new resources that have been published to assist in ensuring people with disabilities and older adults access to COVID-19 vaccines. HHS notes that “these resources clarify legal requirements, illustrate some of the barriers to vaccine access faced by people with disabilities and older people, and provide strategies – and examples of how the aging and disability network can help employ them to ensure accessibility.”

April 14, 2021: H.R. 1868 Becomes a Law – Sequestration Suspension Extended

The Coronavirus Aid, Relief, and Economic Security (CARES) act was enacted on March 27, 2020 and suspended the 2% sequestration payment adjustment applied to all Medicare FFS claims from May 1 through December 31, 2020. This payment adjustment was included in the Budget Control Act signed into law in August 2011 and became effective April 1, 2013. This Act required that $1.2 trillion in federal spending cuts be achieved over the course of nine years. With no action from Congress, sequestration would last until 2022. You can read more about the 2013 Sequestration in an American Medical Association FAQ document.

Additional legislation extended the suspension through March 31, 2021. A subsequent House Resolution (H.R.) finally made its way through the House and Senate. On April 14, 2021, an Act to Prevent Across-the-Board Direct Spending Cuts, and for Other Purposes was signed into law extending the Sequestration suspension through December 31, 2021.

CMS noted in the Friday April 16, 2021 edition of MLN Connects that Medicare Administrative Contractors will:

• Release any previously held claims with dates of service on or after April 16, 2021, and
• The emergency blanket waiver of the timeframe requirements for completing and transmitting resident assessment information (Minimum Data Set (MDS).

They ended the announcement by noting that you do not need to take any action.

April 15, 2021: CDC Clinical Outreach & Communication Call – Johnson & Johnson/Janssen COVID-19 Vaccine and Cerebral Venous Sinus Thrombosis with Thrombocytopenia – Update for Clinicians on Early Detection and Treatment

The CDC held this call to present the latest evidence on cerebral venous sinus thrombosis (CVST) with thrombocytopenia associated with the Johnson & Johnson/Janssen COVID-19 vaccine. If you missed this April 15th call, you can download the call materials from this CDC webpage.

April 15, 2021: OIG Message on COVID-19 Vaccination Program and Provider Compliancet

The OIG released a letter reminding vaccine providers and the public that the Federal Government is providing this vaccine and must be provided at no cost to recipients. They go on to note they are aware of patient complaints about charges by providers when getting their COVID-19 vaccines.

April 15, 2021: COVID-19 Public Health Emergency Extended

Secretary of Health and Human Services, Xavier Becerra, renewed the Public Health Emergency (PHE) due to the continued consequences of the COVID-19 pandemic. This most current extension will expire on July 20, 2021. In January of this year, HHS sent a letter to governors indicating the likelihood that the PHE will remain in place for all of 2021. They also indicated that states would be given a 60 days’ notice to the states prior to the termination of the PHE due to COVID-19.

April 16, 2021: COVID-19 Health Equity Task Force Virtual Meeting April 30, 2021

HHS posted a “Notice of Meeting” regarding the next COVID-19 Health Equity Task Force (Task Force) virtual meeting scheduled for April 30, 2021. As background, this Task Force was established by a January 21, 2021 Executive Order and the group is tasked with making recommendations for “mitigating the health inequities caused or exacerbated by the COVID-19 pandemic and for preventing such inequities in the future.” This meeting is open to the public and will be lived streamed at www.hhs.gov/live. The confirmed time and agenda will be posted on the Task Forces’ webpage at www.minorityhealth.hhs.gov/healthequitytaskforce/.

April 16, 2021: COVID-19 Health Equity Task Force Virtual Meeting April 30, 2021

CMS included the following information regarding COVID-19 Vaccine history in their Friday April 16, 2020 edition of MLN Connects:

“Starting April 16, in addition to screening your patients, you can check Medicare eligibility (PDF) for COVID-19 vaccine administration history from Fee-for-Service (FFS) claims paid for calendar years 2020 and 2021. This includes Medicare Advantage patients.

You can get the following eligibility information for each paid vaccine administration claim:

• CPT or HCPCS codes
• Date of service
• National provider identifier for who administered the vaccine

We can only provide this information if the provider billed Medicare for administering the vaccine. If your patients got vaccinated and the provider didn’t submit a Medicare claim (like if they got vaccinated at a free event), ask your patients about their COVID-19 vaccination history.”

April 16, 2021: Medicare Telehealth Services List Updated

CMS indicated in the April 16, 2021 edition of MLN Connects that CMS had published an updated list of Medicare telehealth services on March 30th. They noted that due to the public health emergency, many audiology and speech-language pathology services have been added to the list effective March 1, 2021.

April 16, 2021: FDA Revokes EUA for Monoclonal Antibody Bamlanivimab

The FDA announced that they have revoked the Emergency Use Authorization (EUA) for Bamlanivimab, when administered alone, to treat mild-to-moderate COVID-19 in adults and certain pediatric patients. Patizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research stated in this announcement that “while the risk-benefit assessment for using bamlanivimab alone is no longer favorable due to the increased frequency of resistant variants, other monoclonal antibody therapies authorized for emergency use remain appropriate treatment choices when used in accordance with the authorized labeling and can help keep high risk patients with COVID-19 out of the hospital.” .