COVID-19 Update: Thursday, December 10

The following is the latest COVID-19 information from the state and federal governments as 5:00 p.m. on Thursday, December 10.

Pennsylvania Update

Governor Wolf

In a news conference held Thursday afternoon from his home in York, where he is under quarantine because he was diagnosed with COVID-19, Governor Wolf announced new state mitigation efforts to attempt to stem the current surge of cases in the state. Joining Governor Wolf for the news conference was Department of Health Secretary Rachel Levine, who also is under quarantine because she recently was exposed to people who have tested positive for the disease. (Members of the governor’s staff and security team have tested positive for COVID-19.)

The new mitigation steps take effect at 12:01 a.m. on Saturday morning, December 12, expire on January 4 at 8:00 a.m., and include:

All in-person indoor dining at restaurants, bars, and other such establishments is prohibited. Outdoor dining is permitted, as is take-out service.
Indoor gatherings and events of more than 10 persons are prohibited. Places of worship are excluded from this limit but urged to find alternative methods of worship.
Outdoor gatherings of more than 50 people are prohibited.
All in-person businesses, such as retail, may operate at only 50 percent of capacity.
Indoor operations at gyms and fitness facilities are prohibited. Outdoor facilities and classes are permitted but participants must wear masks.
All in-person businesses in the entertainment industry serving the public within a building or indoor defined area, including but not limited to theaters, concert venues, museums, movie theaters, arcades, casinos, bowling alleys, private clubs, and other such venues, are prohibited from operating.
Voluntary activities sponsored by or approved by school systems are suspended but may be held virtually.
All sports at K-12 public schools, non-public schools, private schools, and club, travel, and recreational, intermural, and intramural sports are “paused.”
Professional and collegiate sports activities may continue, subject to current CDC and Department of Health guidelines, but spectators are prohibited.

The governor said his administration has engaged state and local law enforcement and other state agencies to help enforce these new requirements. These steps are necessary, he said, because “This virus continues to rage in Pennsylvania.” He also noted that his latest COVID-19 test was negative.

To learn more, go here to see the governor’s news release about the new mitigation efforts; go here to see the governor’s limited-time mitigation order; and go here to see Department of Health Secretary Levine’s limited-time mitigation order.

Department of Health – by the numbers

Pennsylvania’s number of new COVID-19 cases was in five figures yesterday for the sixth time in the past eight days.
The state’s number of COVID-19 cases to date now exceeds 450,000.
Pennsylvania’s overall COVID-19 death toll surpassed 12,000 on Thursday after one of the highest single-day totals the state has suffered since the pandemic began.

Around the State

The Pittsburgh Tribune-Review reports that “Allegheny County on Wednesday reported 34 new coronavirus deaths, a record for a single day, and 727 additional coronavirus cases.”
“Uniontown Hospital has run out of intensive care unit or medical/surgical beds available as it deals with a flood of Covid-19 cases that has hit Fayette County over the last week and forced a significant number of staff to quarantine or isolate due to the virus,” reports the Pittsburgh Business Times. The report continues that “The 145-bed hospital has about 50 Covid-19 patients, up from 25 or so a week ago and the previous peak, earlier in the pandemic, of about a dozen. The ICU unit has been completely converted to COVID-19 care and a secondary ICU unit has been set up within the hospital, and there are COVID-19 patients on multiple floors and in multiple areas. Patients are being held in the emergency department sometimes until a bed opens up.”
With a 43 percent test positivity rate last week, Lycoming County officials, reports the web site northcentralpa.com, are

…putting tighter restrictions on accessibility to public buildings and services. To enter any county facility, a person must be masked. “We are not making exceptions,” said Lycoming County Sheriff Mark Lusk. “We’re going to ask you to go back to your vehicle. We’ll give you a sheet to make the calls that you need to make to make an arrangement with the particular office in the courthouse, to discuss how you want to transact your business.”

Visitors to the courthouse will have to make appointments before arriving. No extra family members will be permitted into courtroom proceedings. Essentially the courthouse will be operating on a “call before you come” basis.

On Wednesday the New York Times published an interactive map that presented the degree to which hospital intensive care units across the country are occupied largely because of COVID-19 patients (based on a data set made available by the federal government on Monday). Among the Pennsylvania areas showing especially high occupation rates were:
- Easton – 104 percent (all ICU beds occupied plus one patient)
- Allentown – 90 percent of 135 ICU beds occupied
- Norristown – 95 percent of 27 ICU beds occupied
- Erie – 94 percent of 111 ICU beds occupied
- Philadelphia – 84 percent of 1113 ICU beds occupied
- Pittsburgh – 87 precent of 698 ICU beds occupied
- Harrisburg – 85 percent of 67 ICU beds occupied
- Reading – 90 percent of 60 ICU beds occupied
- Lancaster – 87 percent of 72 ICU beds occupied

Federal Update

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