The following is the latest COVID-19 information from the federal government as 3:00 p.m. on Thursday, December 10.

Centers for Medicare & Medicaid Services

• CMS has updated its FAQs for Medicare fee-for-service billing with 20 new or updated questions, all marked “12/8/2020,” that address payments for monoclonal antibody treatments and vaccines, including billing and payments for skilled nursing facilities and non-excepted off-campus provider-based departments; requirements for providing antibodies through infusion therapy; and “hospital without walls” flexibilities.  Find the new and updated questions between pages 122 and 135.
• CMS has posted an infographic on coverage of monoclonal antibody products to treat COVID-19.
• In its online publication MLN Matters CMS announced that to support clinicians during the COVID-19 emergency it has extended the 2020 Merit-based Incentive Payment System (MIPS) Extreme and Uncontrollable Circumstances Exception application deadline to February 1.  For the 2020 performance year, MIPS-eligible clinicians, groups, and virtual groups may submit an application asking CMS to reweight one or more performance categories to 0 percent due to the current emergency.  For further information, consult the following resources:
• MIPS Extreme and Uncontrollable Circumstances Exception Application user guide and fact sheet
• How to Submit an Extreme and Uncontrollable Circumstances Exception Application video
• Extreme and Uncontrollable Circumstances Exception webpage
• Quality Payment Program Exceptions Application fact sheet
• Contact the Quality Payment Program at QPP@cms.hhs.gov or 866-288-8292; affected parties who are hearing impaired can dial 711 for a TRS Communications Assistant
• In response to the COVID-19 public health emergency, the following new ICD-10 codes take effect on January 1:
• 21 procedure codes (ICD-10-PCS):  CMS will implement new codes to describe the introduction or infusion of therapeutics, including monoclonal antibodies and vaccines for COVID-19 treatment
• 6 diagnosis codes (ICD-10-CM):  CDC National Center for Health Statistics

See the announcement (ZIP) for more information about assignment of these new diagnosis and procedure codes under the ICD-10 Medicare Severity Diagnosis Related Group (MS-DRG).

• CMS has updated the FAQ for its acute-care hospital “Care at Home” program.
• In MLN Matters CMS has revised a past article about new and expanded flexibilities for rural health centers and federally qualified health centers during the COVID-19 public health emergency.  The update includes additional guidance on telehealth services for which there is cost-sharing and for which cost-sharing is waived.
• CMS and the CDC will hold a call on fundamentals of COVID-19 prevention for nursing homes on January 7 at 4:00 p.m. (eastern).  Go here for information on registration and more.

CMS COVID-19 Stakeholder Calls 

CMS hosts recurring stakeholder engagement sessions to share information about the agency’s response to COVID-19.  These sessions are open to members of the health care community and are intended to provide updates, share best practices among peers, and offer participants an opportunity to ask questions of CMS and other subject matter experts.

COVID-19 Office Hours Call

Tuesday, December 22 at 5:00 (eastern)

Toll Free Dial In:  833-614-0820; Access Passcode:  3968359

Audio Webcast link:  go here.

Conference lines are limited so CMS encourages interested parties to join via audio webcast.

To listen to the audio files and read the transcripts for past stakeholder calls, go here.

Department of Health and Human Services

• HHS has updated its COVID-19 guidance for hospital reporting and FAQs for hospitals, hospital laboratory, and acute-care facility data reporting.  Among the requirements, reporting on COVID-19 therapeutics will be required beginning on January 8, 2021.
• HHS’s Office of the Inspector General has issued an advisory opinion about whether providers can offer other providers or suppliers free items and services related to COVID-19 vaccine storage, distribution, redistribution, or administration.
• HHS has posted a brief case study of the establishment of an alternative care site – a field hospital – in response to a surge of COVID-19 patients.

Food and Drug Administration

• The FDA has authorized the first direct-to-consumer COVID-19 test home collection kit that can be used without a prescription.  This product enables consumers to self-collect a nasal swab sample at home and then send that sample to the manufacturer’s lab for analysis.  Positive or invalid test results are delivered to users by phone call from a health care provider.  Negative test results are delivered via email or online portal.  See the FDA’s announcement here.
• The FDA has posted a notice warning health care providers and patients that patients may be injured if they wear face masks (such as surgical or non-surgical masks and respirators) with metal parts and coatings during a magnetic resonance imaging (MRI) exam
• The FDA has approved an abbreviated new drug application for dexmedetomidine hydrochloride in 0.9% sodium chloride injection, indicated for sedation of initially intubated and mechanically ventilated patients – such as those with COVID-19 – during treatment in an intensive-care setting and sedation of non-intubated patients prior to and/or during surgical and other procedures.

Centers for Disease Control and Prevention

• The CDC has updated its clinical guidance for the management of patients with COVID-19.
• The CDC has updated its toolkit for clinicians.
• The CDC has updated its COVID-19 testing guidelines for nursing home residents and personnel.

Congressional Research Service

• The Congressional Research Service has published a list of all of the temporary provisions related to the COVID-19 emergency that have already expired or will expire at the end of calendar year 2020.