Coronavirus update for Wednesday, June 10 as of 3:00 p.m.

Pennsylvania Update

General Assembly

This week the General Assembly passed a concurrent resolution that seeks to end the governor’s COVID-19 emergency disaster declaration; on June 4 the governor extended that declaration for an additional 90 days.  During a press conference today, Governor Wolf said he will defend in court his right to veto the resolution.  The measure’s proponents believe the resolution, having passed both chambers, is effective and does not require the governor’s consideration.

Department of Health

The Department of Health has issued an order requiring hospitals to implement measures to protect their staff and patients.  The policies and procedures must, at a minimum, include distribution of respirators to hospital staff providing direct patient care to COVID-19-positive and suspected cases and hospital staff assigned to provide direct patient care in COVID-19 units.  Respirator distribution must occur prior to the beginning of the hospital staff member’s shift and respirators must be replaced as soon as practical if the hospital is notified by a staff member that their mask has become soiled, damaged, or otherwise ineffective.  The policies and procedures also must include access to testing upon request for staff members who have been exposed to patients with or suspected of having COVID-19, measures for notifying staff members who have been in contact with such patients, and a requirement that all hospital visitors over the age of two wear masks.  See a news release summarizing the order here.

Department of Health – by the numbers

• Today’s new COVID-19 case and death counts are comparable to what they have been in recent days.
• More than 5800 Pennsylvania health care workers have contracted COVID-19.
• 986 Pennsylvanians are currently hospitalized for COVID-19 and 206 of them are on ventilators.
• 40 percent of state hospitals’ acute-care beds, 39 percent of their ICU beds, 57 percent of their pediatric beds, and 30 percent of their pediatric ICU beds are currently unoccupied.

Department of Human Services

CMS has approved a section 1135 waiver request from DHS’s Office of Medical Assistance Programs.  The waiver permits the state to temporarily allow payments for section 1905(a) personal care services to be rendered by legally responsible individuals and gives the state the ability to modify deadlines for face-to-face encounters required for home health services.  These waivers will remain in effect until the official end of the current public health emergency.

DHS’s Office of Medical Assistance Programs has written to local education agencies participating in its School-Based ACCESS Program to inform them of temporary flexibilities in the program’s usual practices and requirements that it has authorized in response to the COVID-19 emergency.

DHS’s Office of Developmental Programs has published an announcement that provides additional guidance to individual support planning teams on the criteria for requesting a cap exception for the Person/Family Directed Support and Community Living Waivers.  It also has posted a  template for applying for such waivers.

Federal Update

Department of Health and Human Services

On Tuesday HHS announced that it will be distributing $15 billion to clinicians and facilities that participate in state Medicaid and CHIP programs and/or Medicaid and CHIP managed care organizations that have not yet received any general distribution grants from the Provider Relief Fund.

This funding is intended to supply relief to Medicaid and CHIP providers experiencing lost revenues or increased expenses due to COVID-19.  Examples of providers serving Medicaid/CHIP beneficiaries that may be eligible for this funding include pediatricians, obstetrician-gynecologists, dentists, opioid treatment and behavioral health providers, assisted living facilities, and other home and community-based services providers.

Providers that believe they may be eligible for this funding may submit their annual patient revenue information to a new provider relief portal to seek a distribution equal to at least two percent of their reported gross revenues from patient care; that portal is supposed to be established today but was not up at the time this update was written.

Learn more from:

• HHS’s news release announcing this distribution;
• its Provider Relief Fund web page;
• its Provider Relief Fund general information page; and
• its CARES Act Provider Relief Fund FAQ, which has been updated more than two dozen times in the past 48 hours to reflect changes related to yesterday’s announced distributions (additions and modifications are marked within this FAQ).

Centers for Medicare & Medicaid Services

• CMS has published recommendations for health care providers reopening facilities to provide non-emergency non-COVID-19 services.
• CMS has published a guide with information about what patients should know about seeking health care as health care providers begin restoring services.

Food and Drug Administration

• The FDA approved an abbreviated new drug application for succinylcholine chloride injection USP 200 mg/10 mL, which is indicated in addition to general anesthesia to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
• The FDA has issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test using next generation sequence technology.
• The FDA has issued an EUA for a new commercial diagnostic test for COVID-19.

Centers for Disease Control and Prevention

• The CDC has updated its brochure on the use of personal protective equipment when caring for patients with confirmed or suspected COVID-19.
• The CDC has updated its resources for laboratories.
• The CDC has updated its FAQ about COVID-19 for laboratories.
• The CDC has updated its guidance for health care facilities with recommendations and resources.

Resources to Consult

Pennsylvania Department of Human Services

Main COVID-19 Page

COVID-19 Provider Resources

Press Releases

Pennsylvania Department of Health

Main COVID-19 Page

PA Health Alert Network

Centers for Disease Control and Prevention

Main COVID-19 Page

FAQ

(To receive this daily update directly, sign up for our mailing list at   info@pasafetynet.org.)

Coronavirus update for Monday, June 8 as of 2:30 p.m.

Pennsylvania Update

The Wolf Administration

• The Wolf administration announced the launch of an enhanced dashboard with data on COVID-19 in the state. Find the announcement here and the dashboard here.
• The Wolf administration has issued a universal testing order requiring all nursing homes to complete initial baseline testing no later than July 24. It also published updated testing guidance to all long-term-care facilities in the state.  See the announcement here, the nursing home testing order here, and the guidance for long-term-care facilities here.  Also released today as part of this initiative:  requirements for testing of residents and staff in skilled nursing facilities and an FAQ about these requirements.
• The Wolf administration announced that the Public Health Management Corporation will become the state’s health care emergency preparedness vendor as of July 8.

Department of Health – by the numbers

• The weekend’s COVID-19 new case count continued its downward trend while the death count declined significantly.
• More than 5700 health care workers have contracted COVID-19.
• 1174 people are currently hospitalized with COVID-19 and 257 of them are on ventilators.
• The state has seen 20 confirmed cases of multisystem inflammatory syndrome in children (MIS-C). Another 14 possible cases are currently being investigated.

Federal Update

Centers for Medicare & Medicaid Services

CMS has updated its “COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers” document.  Added since the last version are a new section, on page 14, on altered time lines for Medicare’s Comprehensive Care for Joint Replacement Model, along with two modifications:  one on page 10, addressing site-neutral payments for long-term care hospitals, and another on page 13, in support of care for patients in long-term care hospital patients.

CMS – Stakeholder Engagement Calls

CMS hosts recurring stakeholder engagement sessions to share information related to 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 attendees an opportunity to ask questions of CMS and other subject matter experts.  Conference lines are limited so CMS encourages interested parties to join via audio webcast.

Calls recordings and transcripts are posted on the CMS podcast page here.

COVID-19 Office Hours Call

Office Hour Calls provide an opportunity for hospitals, health systems, and providers to ask questions of agency officials regarding CMS’s temporary actions that empower local hospitals and health care systems to increase hospital capacity, expand their workforce, and make greater use of telehealth.

Tuesday, June 9 at 5:00 (eastern)

Toll Free Attendee Dial In:  833-614-0820; Access Passcode: 4892554

Audio Webcast link:  Go here.

COVID Home Health and Hospice Call

Tuesday, June 9 at 3:00 – 3:30 PM (eastern)

Toll Free Attendee Dial-In:  833-614-0820; Access Passcode: 7359947

Audio Webcast Link:  Go here.

COVID Nursing Homes Call

Wednesday, June 10 at 4:30 (eastern)

Toll Free Attendee Dial-In:  833-614-0820; Access Passcode: 9782909

Audio Webcast Link:  Go here.

COVID Dialysis Organizations Call

Wednesday, June 10 at 5:30 (eastern)

Toll Free Attendee Dial-In:  833-614-0820; Access Passcode: 6553907

Audio Webcast Link:  Go here.

COVID Nurses Call

Thursday, June 11 at 3:00 (eastern)

Toll Free Attendee Dial-In:  833-614-0820; Access Passcode: 2863547

Audio Webcast Link: Go here.

Food and Drug Administration

• On Tuesday, June 9 at noon (eastern), the FDA will hold a webinar about emergency use authorizations for respirators, importing respirators, and more. Learn more about the webinar here.
• The FDA is reissuing certain EUAs to specify which respirators are appropriate for decontamination and reuse.
• The FDA has issued EUAs for two new commercial diagnostic tests for COVID-19. Find them here and here.
• The FDA has issued an EUA for a new commercial serology test for COVID-19.
• The FDA has published its temporary policy on prescription drug marketing act requirements for the distribution of drug samples during the COVID-19 emergency.

National Institutes of Health

The NIH has issued a news release describing a study that identifies a potential approach to treating severe respiratory distress in patients with COVID-19.

Congressional Research Service

The Congressional Research Service has published a brief new report called “HIPAA, Telehealth, and COVID-19” that takes a high level look at the interplay among these three considerations from a legal perspective.

Resources to Consult

Pennsylvania Department of Human Services

Main COVID-19 Page

COVID-19 Provider Resources

Press Releases

Pennsylvania Department of Health

Main COVID-19 Page

PA Health Alert Network

Centers for Disease Control and Prevention

Main COVID-19 Page

FAQ

(To receive this daily update directly, sign up for our mailing list at  info@pasafetynet.org.)

Coronavirus update for Friday, June 5 as of 2:30 p.m.

Pennsylvania Update

Department of Health

The Department of Health and Department of Human Services have issued issued guidance for nursing homes, personal care homes, and other long-term and congregate care facilities as counties enter the green phase of reopening.  To prevent further COVID-19 outbreaks within these vulnerable populations, continuing restrictions in long-term and congregate care facilities will remain in place at least 28 days after an individual facility’s county enters the green phase.  Go here to see the Wolf administration’s announcement, here to see the guidance for nursing homes, and here to see the guidance for personal care homes, intermediate care facilities, assisted living residences, and other providers licensed by DHS.

Department of Health – by the numbers

• Yesterday’s new case and death totals were slightly lower than those of the previous day.
• The number of health care workers who have contracted COVID-19 now exceeds 5600.
• 1174 Pennsylvanians are currently hospitalized with COVID-19 and 257 of them are on ventilators – the same figures as the previous day.
• 45 percent of acute-care beds, 38 percent of ICU beds, and 24 percent of pediatric ICU beds are currently unoccupied, as are 53 percent of hospital isolation rooms.

Federal Update

Centers for Medicare & Medicaid Services

In the past week CMS issued six section 1135 waiversto give states greater flexibility to serve their Medicaid beneficiaries during the COVID-19 public health emergency.  It issued waivers to Alaska (two waivers), Arizona, Mississippi, Ohio, and Wisconsin.

Centers for Disease Control and Prevention

• The CDC has updated its guidance on recommendations for people who believe they have been exposed to people with confirmed or suspected COVID-19 when the people to whom they have been exposed are neither health care workers nor critical infrastructure workers – that is, possible community transmission of COVID-19.
• The CDC has updated its FAQ on laboratory biosafety and COVID-19.
• The CDC has updated its guidance for the collection and submission of postmortem specimens from deceased persons under investigation for COVID-19, including recommendations for biosafety and infection control practices during specimen collection and handling, including during autopsy procedures.

Food and Drug Administration

• The FDA approved an abbreviated new drug application for dexmedetomidine hydrochloride in 0.9% sodium chloride injection (ANDA 209307), indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive-care setting.
• The FDA issued a letter to clinical laboratory staff and health care providers about a safety risk with using transport media and SARS-CoV-2 testing platforms that are not compatible. There is a risk of exposure to harmful cyanide gas when certain transport media are used with an incompatible testing platform or laboratory process that uses bleach.
• The FDA has issued an emergency use authorization (EUA) for a new test to assist in identifying severe inflammatory response in patients with confirmed COVID-19 illness to aid in determining the risk of intubation with mechanical ventilation. Find that EUA here and go here for an FDA fact sheet on the known and potential risks and benefits of this test.
• On Tuesday, June 9 at 12:00 p.m. (eastern), the FDA will launch a webinar series on the topic of Respirators for Health Care Personnel Use during COVID-19 Pandemic. The webinar will provide FDA information and answer questions about emergency use authorizations (EUAs) for respirators, importing respirators, and overall FDA actions to help ensure that health care personnel on the front lines have the necessary supplies of respirators to meet the demand. Go here for further information.
• The FDA has updated its enforcement policy for non-invasive remote monitoring devices used to support patient monitoring during the COVID-19 emergency.
• The FDA has posted test performance data from four more serology test kits from its independent performance validation study.
• The FDA has issued an EUA for a new commercial serology test for COVID-19. Find it here.
• The FDA has issued an EUA for a new commercial test to diagnose COVID-19. Find it here.

Resources to Consult

Pennsylvania Department of Human Services

Main COVID-19 Page

COVID-19 Provider Resources

Press Releases

Pennsylvania Department of Health

Main COVID-19 Page

PA Health Alert Network

Centers for Disease Control and Prevention

Main COVID-19 Page

FAQ

(To receive this daily update directly, sign up for our mailing list at  info@pasafetynet.org.)

Coronavirus update for Wednesday, June 3 as of 12:00 p.m.

Pennsylvania Update

Department of Health

The Department of Health has announced that nursing homes located in green counties will continue operating under restrictions for 28 days after the beginning of the green phase in those counties. Those facilities should continue to follow the department’s operations guidance updated on May 12.

The Department of Health issued an update to its dental health care guidance removing the prohibition on non-urgent and non-emergent dental procedures.

Department of Health – by the numbers

• Yesterday’s new case and death figures were slightly lower than those of the previous day.
• More than 18,300 long-term-care residents and workers have contracted COVID-19.
• As have more than 5500 health care workers.
• 1302 Pennsylvanians are currently hospitalized for COVID-19, with 257 of them on ventilators.
• 45 percent of state hospitals’ acute-care beds, 38 percent of their ICU beds, and 24 percent of their pediatric ICU beds are currently unoccupied, as are 53 percent of their isolation rooms.

Federal Update

Centers for Medicare & Medicaid Services

• CMS has updated its FAQ on Medicare COVID-19 fee-for-service billing.  All of the changes address national coverage determinations and are clearly marked within the document.  Providers should review them carefully.
• In response to COVID-19, CMS is providing new flexibilities and adjustments to current and future CMMI models to address the emergency.  It has released a chart that outlines the models and the new changes.  CMS also has written a blog post describing additional CMMI model flexibilities.
• CMS has released guidance to states supporting implementation of the Optional COVID-19 Testing (XXIII) Group­­­ established by the Families First Coronavirus Response Act (FFCRA) for uninsured individuals for COVID-19 testing and testing-related services.  This guidance identifies the different requirements associated with implementing the new group (including eligibility and enrollment, claiming, and data reporting) and provides guidance on strategies that states may employ to meet these requirements.

Department of Health and Human Services

• HHS has updated its CARES Act Provider Relief Fund FAQ.  See additions on pages 5, 14, and 20.  Providers should review these additions carefully.
• HHS announced that the next deadline for submitting data to inform the agency’s distribution of its supply of remdesivir is Monday, June 8 at 8 p.m. (eastern).  HHS is requesting the same data as last month’s remdesivir request:  the number of currently hospitalized COVID-19 patients, and of those hospitalized, the number requiring placement in ICUs.  Hospitals should submit the data using the HHS TeleTracking web portal. ​
• HHS has provided $250 million to help health care systems treating patients and responding to the COVID-19 pandemic.  According to an HHS news release, the money will support hospitals and other health care entities to train workers, expand telemedicine and the use of virtual health care, procure supplies and equipment, and coordinate across jurisdictions and facilities.  Most of this money is going to state hospital associations for distribution.

Centers for Disease Control and Prevention

• The CDC has established a new web page with a data set of health care entities that have received federal claims reimbursement for COVID-19 testing of uninsured individuals and/or treatment for uninsured individuals with a COVID-19 diagnosis as of May 26, 2020.
• The CDC has updated its interim clinical guidance for managing patients with COVID-19.
• The CDC has updated its FAQ about COVID-19 and children.

Food and Drug Administration

• The FDA has published guidance, titled Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators, that includes recommendations regarding procedures for single IRB member review.  This is in response to physician requests for a waiver from the requirement for full IRB review.
• The FDA has added a second ventilator to its list of authorized ventilators, ventilator tubing connectors, and ventilator accessories that was issued in response to concerns relating to insufficient supply and availability of FDA-cleared ventilators for use in health care settings to treat patients during the COVID-19 pandemic. This new ventilator is tailored to provide respiratory support for COVID-19 patients who are experiencing respiratory failure or insufficiency.
• The FDA has added an emergency resuscitator to its list of authorized ventilators, ventilator tubing connectors, and ventilator accessories.  This commercial resuscitator is a continuous respiratory support system that includes an FDA-cleared manual resuscitator and its design is intended for use in treating patients with COVID-19.
• The FDA and the European Medicines Agency have published procedural assistance for sponsors and applicants that anticipate submitting pediatric product development plans for the treatment and prevention of COVID-19.

Department of Labor

The Department of Labor has issued an alert with information about how to keep stockroom and loading dock workers safe during the COVID-19 pandemic.  See an announcement about the alert and the alert itself.

Resources to Consult

Pennsylvania Department of Human Services

Main COVID-19 Page

COVID-19 Provider Resources

Press Releases

Pennsylvania Department of Health

Main COVID-19 Page

PA Health Alert Network

Centers for Disease Control and Prevention

Main COVID-19 Page

FAQ

(To receive this daily update directly, sign up for our mailing list at  info@pasafetynet.org.)