Coronavirus update for Wednesday, May 20 as of 3:00 p.m.

Pennsylvania Update

Department of Human Services

DHS has published a Medical Assistance Bulletin advising providers of the diagnosis coding guidance issued by the CDC for health care encounters related to COVID-19.

DHS has updated its FAQ on CHIP program coverage of COVID-19 testing and related services.

Department of Health

The Department of Health has published an FAQ on its strategy for universal COVID-19 testing in long-term-care facilities.

As of 4:15 on Wednesday afternoon the department had not published its usual news release with a summary of new case and death statistics and other matters and did not provide a daily briefing.

Federal Update

Department of Health and Human Services

• HHS has updated its FAQ for the distribution of CARES Act money through the Provider Relief Fund on four occasions in the past two weeks, including new updates dated yesterday.  Updates from yesterday include instructions on attestation and questions about change in ownership.  Go here to see the changes, which are identified within the document.
• HHS announced that its Health Resources and Services Administration provided $225 million to rural health clinics for COVID-19 testing and shared a state-by-state breakdown of the funding.

Centers for Medicare & Medicaid Services

• For COVID-19 tests that do not use high throughput technology, CMS has announced that Medicare Administrative Contractors have developed payment amounts for claims in their jurisdictions that will be used until CMS establishes national payment rates though the annual laboratory meeting process. The same notice includes reminders about other payment policies implemented in response to the COVID-19 crisis.
• CMS has published a therapy codes update that includes the addition of codes related to the COVID-19 emergency.
• CMS has posted information for hospitals requesting Medicare approval for swing beds as a hospital service to provide skilled nursing care for hospitalized patients who do not need acute care but cannot find nursing home placement during the COVID-19 crisis.
• During the COVID-19 emergency, CMS is relaxing billing requirements for a limited number of laboratory tests required for a COVID-19 diagnosis. Any health care professional authorized under state law may order these tests and Medicare will pay for these tests without a written order from the treating physician or other practitioner.
• During the COVID-19 crisis, Medicare will cover medically necessary emergency and non-emergency ground ambulance transportation from any point of origin to a destination that is equipped to treat the condition of the patient consistent with state and local emergency medical services protocols where the services will be furnished.
• CMS’s Office of Minority Health has compiled federal resources on COVID-19 to assist those who work with vulnerable patients, such as older adults, those with underlying medical conditions, racial and ethnic minorities, rural communities, and people with disabilities.

Centers for Disease Control and Prevention

• The CDC has posted its original plan for guiding the reopening of the country. This is the detailed, 60-page plan that was not released publicly but was instead revised into a series of shorter advisory documents.
• The CDC has updated its information for pediatric providers about multi-system inflammatory syndrome in children (MIS-C).

Food and Drug Administration

• The FDA approved the use of succinylcholine chloride injection to facilitate tracheal intubation and provide skeletal muscle relaxation during surgery or mechanical ventilation.
• The FDA has issued emergency use authorization for a specific commercial diagnostic test for COVID-19.

Congressional Research Service

The CRS has published a new report titled “FCC COVID-19 Telehealth Program and Connected Care Pilot Program: Funding to Assist Health Care Providers and Patients.”

Department of Labor

The department’s Occupational Safety and Health Administration has adopted revised policies for enforcing OSHA’s requirements involving COVID-19 as economies reopen in states throughout the country.

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 Tuesday, May 19 as of 2:30 p.m.

Pennsylvania Update

Governor Wolf

Governor Wolf has vetoed three COVID-19-related bills.

• Senate Bill 317 would have authorized counties to develop and implement their own mitigation plans and decide when businesses within their county could reopen and would have prohibited state agencies from promulgating regulations until 90 days after the COVID-19 emergency declaration is terminated except with permission from the legislation
• House Bills 2388 and 2412 would have permitted various industries to reopen in red phase counties.

See the governor’s news release announcing the vetoes and also find links to his veto messages for each of the bills.

Department of Health

The department announced that the CDC has sent three teams to Pennsylvania to help with the state’s response to COVID-19.  The teams arrived last week and will stay for two weeks, with two teams assisting with long-term-care facilities and one team helping to address food facility outbreaks.  They will teach infection control practices, provide training on the use of personal protective equipment and outbreak response, and assist with developing the state’s testing strategy for nursing homes.

Department of Health Daily Briefing

• The state continues to report high death figures as the number of new cases continues to decline. Secretary Levine explained that this results from a combination of the continued reconciliation of past case data and deaths resulting from times when the case counts were higher.  The death figures should eventually reflect the declining case counts, she said.
• The state has seen its first pediatric death from COVID-19.
• More than 16,000 residents and employees in 557 long-term-care facilities in 44 counties have been diagnosed with COVID-19. More than 3100 of those residents have passed away from the disease.
• Secretary Levine discussed the work of the three teams from the CDC (described above) and said the teams working with long-term-care facilities would be developing facility-specific testing plans for nursing homes.
• The department’s web site now has case and death data for all long-term-care facilities regulated by the Department of Health and Department of Human Services.
• Secretary Levine said the state is ahead of its schedule for increasing testing in Pennsylvania.
• Contact tracing is under way in all of the yellow counties with adequate staffing but the state is also working to increase that staffing.

Department of Human Services/Office of Long-Term Living

Noting that federal guidance directs nursing homes to restrict visitors and non-essential personnel to protect residents, OLTL announced that Pennsylvania has received approval to use funds from civil money penalties for the purchase of technology that enables residents to engage in virtual social and telehealth visits in the absence of visitors.  Facilities interested in pursuing such resources can learn more from this FAQ for state Medicaid agencies and use this application template.

Federal Update

Department of Health and Human Services

• HHS has updated its FAQ for the distribution of CARES Act money through the Provider Relief Fund on three occasions in the past two weeks. Go here to see the changes, which are identified within the document.
• HHS is providing $11 billion in new funding to support COVID-19 testing to states, territories, and tribes. States must submit to HHS their projected month-to-month testing plans and capabilities for the rest of calendar year 2020.

Centers for Medicare & Medicaid Services

• CMS issued recommendations on the safe reopening of nursing homes. See CMS’s announcement, the recommendations, and an FAQ.

Centers for Disease Control and Prevention

• The CDC updated its interim infection prevention and control recommendations for patients with suspected or confirmed COVID-19.
• The CDC has updated its advice on strategies for optimizing the supply of personal protective equipment.

Food and Drug Administration

• The FDA published guidance on the implementation of acceptable full-length and abbreviated donor history questionnaires and accompanying materials for use in screening donors of source plasma.
• On Wednesday, May 20, the FDA will hold a virtual town hall meeting for clinical laboratories and commercial manufacturers that are developing or have developed COVID-19 diagnostic tests to answer technical questions about the development and validation of such tests. The FDA will hold another such town hall next Wednesday, May 27.

National Institutes of Health

The NIH has launched a multi-pronged study to understand the effects of the COVID-19 pandemic during and after pregnancy. The study will be conducted by researchers in the Maternal-Fetal Medicine Units Network, a group of 12 U.S. clinical centers funded in part by the NIH.

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.)

COVID-19 update for Monday, May 18 as of 2:30 p.m.

Pennsylvania Update

Department of Health

The Department of Health issued revised guidance for health care providers that have not already received guidance on how to reopen elective procedures.  The guidance would not apply to hospitals, ambulatory surgical facilities, dental practices, and any others operating under separate department guidance.

The department issued additional clarification late Friday about Secretary Levine’s order for nursing homes to report information about COVID-19 patients to the Department of Health.

Because of the serious implications that COVID-19 has had and is having for the residents and staff of nursing homes, and the surrounding communities, and because of the need for the most timely and accurate data the Department of Health is able to obtain, the Secretary of Health has chosen to exercise her public health authority and issue an Order requiring the reporting in question. The Department of Health has provided instructions today to all skilled nursing facilities regarding how to report into its system for this purpose. The Department is requiring facilities to report daily, even over weekends and holidays, precisely because of the serious consequences that spread of the virus has for nursing home residents, its ability to spread asymptomatically, and the need for the most current, timely and accurate data to inform the Commonwealth’s response.

Information provided to skilled nursing facilities by the Department today did also include a letter reminding them of their obligations under CMS’ new regulations. This letter, while intended to be a timely reminder of those federal regulatory obligations, was not intended to define their obligations under the Secretary’s public health Order. The Secretary’s Order stands separate and apart from requirements mandated by CMS and is authorized by her authority to protect the health of the people of this Commonwealth, and to determine and employ the most efficient and practical means for the prevention and suppression of disease. Therefore, the letter detailing federal requirements relating to CMS should be disregarded for purposes of complying with the Secretary’s Order. The Department is not taking the issuance of this Order as a regulatory step, but as a public health imperative.

Department of Health Daily Briefing

• More than 13,600 residents of long-term-care facilities and more than 2000 people who work at such facilities have tested positive for COVID-19.  Those cases are spread over 561 facilities in 44 counties.
• Nearly 69 percent of all COVID-19-related deaths in Pennsylvania have been people who resided in long-term-care facilities.
• Nearly 4500 health care workers have tested positive for COVID-19, as have more than 2400 people employed in the food industry in 159 different facilities.
• Secretary Levine explained that the state is now using a new death reporting system.  When publicly reporting long-term care deaths, they will be reported based on the county of the facility.  When reporting overall deaths, patients who passed away in long-term-care facilities – and those who do so in hospitals as well – will be reported based on their county of residence, not the county where the long-term-care facility or hospital was located.
• More testing at long-term-care facilities will be introduced this week but it will not necessarily be weekly testing.  The frequency of testing will be based on the situations of the individual facilities.
• Case and mortality data for individual long-term-care facilities will be publicly reported beginning tomorrow.
• Secretary Levine reported that the state is still seeking to acquire COVID-19 antibody testing for state labs and hopes to have it by the end of the month but some hospitals, as well as LabCorp and Quest, already have this capacity.  She warned that the value of such tests is still not entirely clear.

Federal Update

Centers for Medicare & Medicaid Services

• CMS has posted a compendium of COVID-19-related flexibilities it has authorized for ambulance services during the COVID-19 crisis.
• CMS has updated its collections of COVID-19-related waiver flexibilities for several types of health care providers.
  • For health care providers, a new section on ambulance services and the Medicare ground ambulance data collection system (p. 29).
  • For hospitals, new provisions addressing specific life safety code matters for hospitals (p. 3); expanded ability for hospitals to offer long-term-care services (swing beds) (p. 6); hospitals classified as sole-community hospitals (p. 7); and hospitals classified as Medicare-dependent small rural hospitals (p. 7).
  • For teaching hospitals, teaching physicians, and medical residents, new sections on the expanded ability of hospitals to offer long-term-care services (swing beds) for patients who do not require acute care but do meet the skilled nursing facility level-of-care criteria (p. 5) and its waiving of certain physical requirements under the Medicare conditions of participation to allow for increased flexibilities for surge capacity and patient quarantine at hospitals, psychiatric hospitals, and critical hospitals as a result of COVID-19 (p. 6).
  • For long-term-care facilities (skilled nursing facilities or nursing facilities), a new section on the training required for paid feeding assistants (p. 11).
  • For home health agencies, a new provision that permits occupational therapists, physical therapists, and speech language pathologists to perform initial and comprehensive assessments for all patients and not only for patients for whom physical therapy has been ordered (see page 4).
  • For end-stage renal disease facilities, new information about the requirement that facilities furnish dialysis services on the main premises (p. 5).

CMS Weekly Stakeholder Calls

COVID-19: Office Hours Call — May 19

Tuesdays and Thursdays from 5 to 6 pm ET

Hospitals, health systems, and providers: Ask CMS questions about its temporary actions.

To Participate on May 19:

• Conference lines are limited but you also can join via audio webcast
• Or, call 833-614-0820; Access Passcode: 9984433

Target Audience: Physicians and other clinicians

COVID-19: Home Health and Hospice Call — May 19

Tuesdays from 3 to 3:30 pm ET

These calls provide targeted updates on the agency’s latest COVID-19 guidance. Leaders in the field also share best practices.  There is an opportunity to ask questions if time allows.

To Participate on May 19:

• Conference lines are limited but you also can join via audio webcast
• Or, call 833-614-0820; Access Passcode: 6477704

COVID-19: Nursing Home Call — May 20

Wednesdays from 4:30 to 5 pm ET

These calls provide targeted updates on the agency’s latest COVID-19 guidance.  Leaders in the field also share best practices.  There is an opportunity to ask questions if time allows.

To Participate on May 20:

• Conference lines are limited but you also can join via audio webcast
• Or, call 833-614-0820; Access Passcode: 4879622

COVID-19: Dialysis Organization Call — May 20

Wednesdays from 5:30 to 6 pm ET

These calls provide targeted updates on the agency’s latest COVID-19 guidance.  Leaders in the field also share best practices.  There is an opportunity to ask questions if time allows.

To Participate on May 20:

• Conference lines are limited but you also can join via audio webcast
• Or, call 833-614-0820; Access Passcode: 3287645

COVID-19: Nurses Call — May 21

Thursdays from 3 to 3:30 pm ET

These calls provide targeted updates on the agency’s latest COVID-19 guidance.  Leaders in the field also share best practices.  There is an opportunity to ask questions if time allows.

To Participate on May 21:

• Conference lines are limited but you also can join  via audio webcast
• Or, call 833-614-0820; Access Passcode: 2874976

COVID-19: Office Hours Call — May 21

Tuesdays and Thursdays from 5 to 6 pm ET

Hospitals, health systems, and providers: Ask CMS questions about its temporary actions.

To Participate on May 21:

• Conference lines are limited but you also can join via audio webcast
• Or, call 833-614-0820; Access Passcode: 9984433

Target Audience: Physicians and other clinicians

COVID-19: Lessons from the Front Lines Call — May 22

Fridays from 12:30 to 2 pm ET

These weekly calls are a joint effort between CMS Administrator Seema Verma, Food and Drug Administration Commissioner Stephen Hahn, MD, and the White House Coronavirus Task Force. Physicians and other clinicians: Share your experience, ideas, strategies, and insights related to your COVID-19 response. There is an opportunity to ask questions.

To Participate on May 22:

• Conference lines are limited but you also can join via audio webcast
• Or, call 877-251-0301; Access Code: 6086125

To catch up on past calls, go here for transcripts and podcasts.

Department of Health and Human Services

• ASPR TRACIE, sponsored by HHS’s Office of the Assistant Secretary for Preparedness and Response (ASPR) to provide Technical Resources, Assistance Center, and Information Exchange (TRACIE) services, has published a summary on funding for alternative care sites for helping to increase hospital surge capacity in communities overwhelmed by patients diagnosed with COVID-19.  In particular, see the charts on pages 3 and 4.
• HHS will be distributing another large quantity of the drug remdesivir to state health departments later this week.  Those state health departments, in turn, will distribute the drug to their states’ hospitals as they believe appropriate.  This distribution is about the same size as last week’s.  Another, smaller distribution is expected next week.

Neither this week’s nor next week’s distributions require any action by hospitals; they do not have to provide any data through the COVID-19 teletracking portal.

Gilead, manufacturer of remdesivir, is expected to donate more than 300,000 additional vials to the federal government in early June.  Hospitals will be asked to input their COVID-19 data through the teletracking portal in early June as that next donation draws closer.

Centers for Disease Control and Prevention

The CDC updated its information for pediatric health care providers on multi-system inflammatory syndrome in children (MIS-C).

Food and Drug Administration

The FDA has issued an emergency use authorization (EUA) for an at-home sample collection kit that can then be sent to specified laboratories for COVID-19 diagnostic testing.

• The FDA has issued an EUA for a commercial device to be used for remote monitoring of cardiograms among COVID-19 patients whose hearts may be susceptible to cardiac arrhythmias when taking certain prescription drugs.
• The FDA has updated its guidance document on conducting clinical trials of medical products during the COVID-19 emergency.

• The FDA has issued EUAs for four new commercial diagnostic tests for COVID-19.  Find them here, here, here, and 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.)

COVID-19 update for Friday, May 15 as of 2:30 p.m.

Pennsylvania Update

Governor Wolf

Governor Wolf announced that 12 more counties will move to the yellow phase and begin reopening next Friday, May 22.  This will bring 49 of Pennsylvania’s 67 counties into the yellow phase of partial reopening.

Department of Health

The Department of Health has issued an order requiring nursing homes to report to the department daily beginning on May 16 the same information CMS requires these facilities to report to the CDC under the interim final rule issued on May 8.  Click here for a letter from CMS to states explaining these requirements.

Department of Health Daily Briefing

• Nearly 1000 new cases of COVID-19 brings Pennsylvania’s total to more than 60,000.
• Nearly 13,000 residents of long-term-care facilities and more than 2000 who work in 550 such facilities in 44 counties have tested positive for COVID-19.
• As have more than 4300 health care workers and nearly 2400 people who work in 150 food facilities.
• Pennsylvania has cut its case count in half in recent weeks.
• But the state is still seeing pockets of outbreaks and some parts of the state are only now beginning to show signs of declining cases.
• Secretary Levine said testing and contact tracing are working well in yellow counties.
• Secretary Levine confirmed that the state now has cases of multi-system inflammatory syndrome in children (MIS-C) associated with COVID-19. She said she has no information about how many such cases there are and where in the state these children live.

General Assembly

The House is scheduled to reconvene next Monday and the Senate canceled its session for next week.

Federal Update

Centers for Medicare & Medicaid Services

• CMS released a bulletin that gives guidance to states on how to temporarily modify provider payment methodologies and capitation rates under their Medicaid managed care contracts to address the impact of the COVID-19 emergency while preserving systems of care and access to services for Medicaid beneficiaries.  See CMS’s announcement of the bulletin here and find the bulletin itself here.
• CMS updated its COVID-19 FAQ on Medicare fee-for-serving billing with new information about accountable care organizations that terminate their Shared Savings Program agreement (p. 40).
• HHS’s Office of the Inspector General updated its FAQ addressing how it will apply its administrative enforcement authorities to arrangements directly connected to the COVID-19 public health emergency.  The new information makes clear the circumstances under which a physician group that contracts with a nursing home to provide care to its residents could furnish protective face masks to the nursing home at no or reduced cost during the COVID-19 crisis.
• HHS’s Office of Civil Rights published a notice of enforcement discretion informing interested parties that it will not impose penalties for non-compliance with regulatory requirements under the HIPAA rules against covered health care providers and their business associates in connection with their good-faith participation in the operation of a community-based testing site during the public health emergency.
• In the past week CMS issued 13 section 1135 waivers to give states greater flexibility to serve their Medicaid beneficiaries during the COVID-19 public health emergency.  The states receiving waivers this week are Alabama, Alaska, California, Connecticut, Georgia, Indiana, Louisiana, Massachusetts, Minnesota, Missouri, Nebraska, and Oregon and the District of Columbia.
• CMS posted a message announcing temporary changes in its Medicare Diabetes Prevention Program as a result of the COVID-19 crisis.
• CMS issued a call for nominations for individuals to serve on its Coronavirus Commission on Safety and Quality in Nursing Homes.  The commission process will be led by a contractor that will, among other things, manage the nomination and selection of commission members.

Department of Health and Human Services

HHS and its Agency for Healthcare Research and Quality (AHRQ) will award $5 million in fiscal year 2020 to support novel, high-impact studies that evaluate the responsiveness of health care delivery systems, health care professionals, and the overall U.S. health care system to the COVID-19 pandemic.   See HHS’s announcement of the grant program here and find the full funding announcement here.

Centers for Disease Control and Prevention

The CDC issued a health advisory through its health alert network with background information on several cases of a recently reported multi-system inflammatory syndrome in children (MIS-C) associated with COVID-19.  The advisory includes a case definition for this syndrome and the CDC’s recommendation that providers report any patient who meets the case definition to local, state, and territorial health departments to enhance knowledge of risk factors, pathogenesis, clinical course, and treatment of this syndrome.

Food and Drug Administration

• The FDA issued a news release alerting the public to early data that suggests potentially inaccurate results from using the Abbott ID NOW point-of-care test to diagnose COVID-19.  Specifically, the test may return false negative results.

• The FDA issued an update to its guidance for pharmacy compounders that experience shortages of the personal protective equipment they typically use to compound human drugs that are intended or expected to be sterile.  In the update, FDA clarifies that drugs can be compounded under the policy in a segregated compounding area that is not in a cleanroom when specific beyond-use dates are used.

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.)

COVID-19 update for Thursday, May 14as of 2:30 p.m.

Pennsylvania Update

Governor Wolf

The Wolf administration released an updated Carnegie Mellon University Risk-Based Decision Support Tool report for May 12.  The support tool is used when making decisions about which Pennsylvania counties to reopen.

Department of Health

On its message board for licensed entities (go here and click “message board”), the Department of Health sent the following reminder to skilled nursing facilities:

As the COVID-19 pandemic unfolds, the Department is aware that some skilled nursing care facilities may struggle with adequate staffing.  Despite this challenge, the facility remains responsible for providing adequate care and maintaining a safe environment for residents.  The Department will continue to uphold its regulatory responsibilities but will not cite a facility based solely on a request for assistance from federal, state, and local resources such as the National Guard, the Department’s consultant, ECRI, Inc., or others. The Department expects facilities to reach out for assistance during this unprecedented time.

Department of Health Daily Briefing

• With 275 new deaths to report, most of which are the result of reconciling past case data, Pennsylvania’s COVID-19 death toll now exceeds 4000 people. All were adults.
• More than 12,600 residents of long-term-care facilities and nearly 2000 employees in those facilities have tested positive for COVID-19, as have more than 4000 health care workers.
• Secretary Levine discussed strategies for pediatricians to provide well-child visits and ensure that children stay current with their immunizations.
• Department of Health officials are contacting the state’s six children’s hospitals about whether they have seen any cases of a COVID-19-related inflammatory syndrome that shows similar symptoms to Kawasaki disease, which is a childhood illness. Despite published reports, Secretary Levine said she is unaware of any such cases in the state.
• Secretary Levine announced that CVS will begin performing drive-through testing at some of its locations using self-swabs. She does not know the criteria CVS will employ for whom it tests.  Rite Aid testing locations will test anyone.
• Secretary Levine said there have been no troubling spikes in case counts in counties that have moved from red to yellow but warned that only five days have passed since those reopenings.
• Next week the state will begin considering criteria for moving counties and regions from yellow to green.
• Secretary Levine expressed no opinion when asked about HAP’s complaints about the governor’s veto of telehealth legislation, the state helping hospitals with loans instead of grants, and other matters.
• The state has no plans to reopen any areas on anything less than a county-wide area.

Department of Human Services

• DHS reissued its comprehensive guidance document for hospitals to reflect a requirement to test patients for COVID-19 prior to discharge to a nursing care facility, personal care home, or assisted living residence.
• DHS issued new guidance documents for nursing homes summarizing several recent health alerts on topics such as testing protocols for residents returning from a hospital, cohorting patients, and periodic screening of residents and staff. Find those documents here and here.

• DHS has posted a notice about the reprocessing of Medicaid fee-for-service claims with COVID-19-related diagnosis code and co-pay collection.

Federal Update

Department of Health and Human Services

HHS is sending out its largest distribution of remdesivir this week. As of this week, HHS will have sent out 40 percent of its current supply.  The drug is being sent to state health departments, which will distribute it to hospitals.   Hospitals are being asked to update their data on COVID and suspected COVID inpatients and ICU patients on a weekly basis via the teletracking portal.  The next deadline is Monday, May 18 at midnight.  Once the federal supply is exhausted the federal government will not receive any additional donated doses of the drug.

Federal Emergency Management Agency

FEMA has updated its policy on COVID-19 medical costs eligible for public assistance under the agency’s FEMA Public Assistance Program. Eligible recipients for these funds include state, local, tribal, and territorial entities and certain private, non-profit organization-owned and/or operated medical facilities.

Department of Homeland Security/U.S. Citizenship and Immigration Services

The U.S. Citizenship and Immigration Services has issued a policy memorandum describing temporary policy changes for certain foreign medical graduates during the COVID-19 emergency.  The temporary policy addresses situations in which H-1B foreign medical graduates are temporarily unable to work full-time due to quarantine, illness, travel restrictions, or other consequences of the pandemic during the COVID-19 emergency.

Centers for Medicare & Medicaid Services

CMS has issued a new toolkit on state actions and best practices to mitigate the prevalence of COVID-19 in nursing homes.

Occupational Safety and Health Administration

OSHA has issued an alert with information to keep nursing home and long-term care facility workers safe during the COVID-19 pandemic.

Substance Abuse and Mental Health Services Administration

SAMHSA is inviting applications for $40 million in grants to support states and communities during the COVID-19 pandemic in advancing efforts to prevent suicide and suicide attempts among adults 25 and older in order to reduce the overall suicide rate and number of suicides in the United States.

National Institutes of Health

The NIH announced that a clinical trial has begun to evaluate whether hydroxychloroquine, given together with the antibiotic azithromycin, can prevent hospitalization and death from COVID-19.

Food and Drug Administration

• The FDA has posted information about thermal imaging systems and their uses, and limits, in serving confirmed and suspected COVID-19 patients. This information supplements the agency’s enforcement policy for telethermographic systems during the COVID-19 emergency, which was issued last month.

• On Friday, May 15, the FDA will hold a virtual town hall for researchers, clinical laboratories, and commercial manufacturers to discuss the production and use of 3D-printed swabs during the COVID-19 crisis. Learn more here.

• In light of an insufficient supply of infusion pumps and infusion pump accessories needed to treat COVID-19 patients, the FDA has written to the manufacturers of such equipment, health care providers, distributors, and other stakeholders outlining the conditions under which it will issue emergency use authorizations (EUA) for infusion pumps and infusion pump accessories.

• The FDA has issued EUAs for four specific commercial diagnostic tests for COVID-19; find them here, here, here, and 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.)

COVID-19 update for Wednesday, May 13 as of 2:30 p.m.

Pennsylvania Update

Governor Wolf

Governor Wolf announced that gender identity, sexual orientation, and expression will be included in the state’s COVID-19 data collection.

Department of Health

The Department of Health announced its plans for distributing 1200 doses of remdesivir that it has received from the federal government.  See its announcement, including links to the department’s distribution formula and a list of the 51 recipient hospitals.

Department of Health Daily Briefing

• The state’s new COVID-19 case count was down over the past 24 hours but the death count climbed as a result of continued reconciliation of past data.
• More than 12,400 residents of long-term-care facilities and 1800 employees of those facilities have been diagnosed with COVID-19.
• As have more than 4000 health care workers across the state.
• Secretary Levine announced that the state has distributed more than 1200 doses of remdesivir, a drug that preliminary clinical trials suggest can help people recover from COVID-19 (see link above for the department’s formal announcement). The federal Department of Health and Human Services is managing distribution of the drug among the states and has assured that Pennsylvania will receive more in the future.
• Pennsylvania now has the laboratory capacity to do much more testing.
• The state is now able to test those who in the past were considered likely cases of COVID-19 but were not tested because of the scarcity of testing supplies.
• But while the state’s goal is broad surveillance testing, that is not yet possible.

Department of Human Services

• DHS has posted a notice that nurse aide testing is suspended until May 16, 2020 or until conditions are deemed safe to reopen.
• DHS’s Bureau of Human Services Licensing has published an FAQ on how economic impact payments made under the federal CARES Act might affect the Medicaid eligibility of residents of personal care homes and assisted living facilities who participate in programs operated by the department’s Office of Long-Term Living. The FAQ also addresses how such facilities must handle those payments on their residents’ behalf.

State Board of Medicine

The State Board of Medicine has suspended a regulation requiring physicians to provide paper prescriptions within 72 hours of issuing emergency prescriptions by telephone during the COVID-19 emergency.

Attorney General

State Attorney General Josh Shapiro has announced that his office has opened criminal investigations into “several” nursing homes for possible criminal neglect of patients and residents.

General Assembly

• Yesterday the Senate unanimously passed SB 1122, which would appropriate $507 million in federal CARES Act money to state long-term care budget lines. This was added as an amendment to a bill that directed $34 million in CARES Act money to firefighters and EMS service.  Find further information in the fiscal note on the bill.
• Senate leaders said that in light of the unpredictability of the COVID-19 pandemic and state revenues, they are working on a five-month state budget that would run from July through November and would therefore require additional budget legislation to cover state spending as of December 1, 2020.
• House Speaker Mike Turzai has introduced HB 2510, the Senior Protection Act, which would spend $500 million in federal CARES Act money to address the spread of COVID-19 in long-term-care facilities. Unveiled earlier this week, the bill focuses on three areas: enhancing testing capabilities, infection control, and advancing clinical practices including the use of telemedicine.  According to the Speaker, this would be accomplished by utilizing Pennsylvania’s academic medical centers (AMC) to ensure greater protection of seniors.
• The House is expected to return to session on Thursday, May 14.

Federal Update

Centers for Medicare & Medicaid Services

• CMS has posted an FAQ on price transparency and requirements for providers to make public their cash prices for COVID-19 diagnostic testing.

Centers for Disease Control and Prevention

• The CDC has updated its FAQs for health care personnel working among and around patients who have or are suspected of having COVID-19.
• The CDC has updated its resources for hospitals and health care professionals preparing for patients with suspected or confirmed COVID-19.
• The CDC has published information providing a framework for health systems providing non-COVID-19-related services during the COVID-19 pandemic.
• The CDC has updated its FAQ for laboratories that perform or wish to perform COVID-19 tests.
• The CDC has updated its information for pediatric providers.
• The CDC has posted information about COVID-19 and patients on home dialysis.
• The CDC has published guidance on serving patients in memory care units of long-term-care facilities and dealing with COVID-19 in this context.

Food and Drug Administration

• The FDA has updated its information for blood establishments regarding the COVID-19 emergency.

• The FDA has issued emergency use authorization (EUA) for a commercial nurse call system for use by providers for remotely monitoring and communicating with patients on ventilators.

• The FDA has issued an EUA for a commercial cardiogram system to be used as a diagnostic aid for identifying potential cardiac complications associated with COVID-19 or underlying conditions that may affect the clinical management of patients who have or are suspected of having COVID-19.

• The FDA has issued an EUA for a specific commercial diagnostic test for COVID-19.

Government Accountability Office

• The GAO has published a brief review of the science underlying social distancing.

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.)

COVID-19 update for Tuesday, May 12 as of 3:00 p.m.

Pennsylvania Update

Department of Health

The Department of Health has issued an advisory calling on skilled nursing facilities to develop and implement plans to perform COVID-19 tests on their residents and employees.

Department of Health Daily Briefing

• Nearly 14,000 residents of long-term-care facilities and people who work at those facilities have now tested positive for COVID-19.
• As have nearly 4000 other health care workers.
• The state is introducing a new testing strategy for the residents and employees of skilled nursing facilities that calls for testing every resident of every such facility. All patients who are returning to such facilities from hospitals must be tested and then accommodated appropriately.  The Department of Health issued guidance on its new approach today.  This guidance, linked above, calls for different levels and frequency of testing for different facilities based on how many COVID-19 cases they have had and how recently they have had them.
• Secretary Levine said the state is introducing this strategy now because it is the first time it has had sufficient access to testing supplies and equipment and laboratory resources to undertake such an effort.
• She said the department also has directed skilled nursing facilities to report daily, starting May 17, on their testing activity and case counts. This information will be reported publicly.

Department of Human Services/Office of Long-Term Living

OLTL has issued a reminder to OLTL-regulated programs operating in counties that are moving from red to yellow that previous guidance that applied to those programs remains in effect.  Specifically:

• For programs involving home and community-based services, this DHS memo to Community HealthChoices managed care plans addressing temporary changes in the Community HealthChoices program and this notice to OBRA waiver service coordinators and providers describing temporary changes of the OBRA waiver.
• For nursing facilities, this DHS clarification guidance for pre-admission screening resident review (PASRR); Department of Health interim guidance on visitation in nursing facilities during the COVID-19 emergency; and CMS guidance for infection control and prevention.
• For Living Independence for the Elderly (LIFE) programs, OLTL’s LIFE provider guidance related to COVID-19.
• For assisted living residents and personal care homes, the Department of Health’s interim guidance on visitation to nursing facilities during the COVID-19 pandemic; CMS’s guidance for infection control and prevention; OLTL’s guidance suspending and restricting license requirements for personal care homes and assisted living residences; and DHS’s visitation restrictions in personal care homes and assisted living residences.

Federal Update

Congress

House Democrats have unveiled their newest pandemic relief bill.  The overall bill is estimated to cost around $3 trillion.  A few of the health care provisions included in this bill are:

• $100 billion for eligible health care providers to be distributed through the Health Care Provider Relief Fund. This is in addition to the $175 billion Congress has already appropriated for providers.  This bill would include a prescriptive and structured methodology for distribution of the Health Care Provider Relief Fund that would include, among other things:
• quarterly relief funds based on hospital cost reports, with aid providers already received from the relief fund subtracted from the quarterly amount
• eligibility to receive up to 60 percent of revenue lost in comparison to the previous year, to help compensate for pandemic-related expenses
• a requirement that recipients not charge COVID-19 patients and not engage in balance billing
• Reduces interests rates and lengthens the payback period for Part A and Part B advance payments.
• $75 billion for testing, contact-tracing, and other activities.
• Prohibits the administration from finalizing the Medicaid Fiscal Accountability Rule (MFAR) during the current public health emergency.
• $7.6 billion to health centers.
• $4.5 billion to NIH to expand COVID-10-related research.
• $3 billion for the Substance Abuse and Mental Health Services Administration (SAMHSA).
• Increases federal medical assistance percentage (FMAP) 14 percentage points from July 1, 2020 through June 30, 2021.
• Temporarily increases Medicaid DSH allotments to states by 2.5 percent.
• Eliminates cost-sharing for most patients for COVID-19 treatment.

These are only a few of the health care provisions included in this sprawling bill.  You can find a summary of the bill here and the text of the bill here.

The House is expected to vote on the bill this Friday but the Senate is working on its own plan and is not expected to take up any new pandemic relief legislation until after Memorial Day.

Centers for Disease Control and Prevention

• The CDC has published information about factors to consider when purchasing ventilators from another country.
• The CDC has updated its FAQ on infection prevention and control in health care settings.
• The CDC has updates its interim laboratory biosafety guidelines for handling and processing specimens associated with COVID-19.

Food and Drug Administration

• The FDA has published guidance for industry and investigators addressing pre-investigational new drug application (IND) meeting requests for COVID-19-related drugs and biological products.

• The FDA has published guidance on developing drugs and biological products for the treatment or prevention of COVID-19.

• The FDA has issued an emergency use authorization for a specific commercial laboratory test to diagnose COVID-19.

Occupational Safety and Health Administration

OSHA issued an alert with information about helping to keep dental industry practitioners safe during the COVID-19 emergency. See the announcement here and the alert itself 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.)

COVID-19 update for Monday, May 11 as of 2:30 p.m.

Pennsylvania Update

Governor Wolf

Governor Wolf held a news conference during which he spoke about the state’s need to stay the course in the fight against COVID-19 and responded to the plans of certain Pennsylvania county officials to move their counties to the yellow phase of reopening on their own.  See his remarks here.

Department of Health

The Department of Health has posted revised guidance on COVID-19 for dental services.  The guidance revises past business closure orders and removes the prohibition against elective (non-urgent, non-emergency) dental procedures under specific conditions.

The department has posted a health alert with information about pediatric multi-system inflammatory syndrome, a condition potentially associated with COVID-19.  The alert calls for hospitals to report to the Department of Health any patients meeting clinical criteria consistent with this condition regardless of COVID-19 testing results.

Department of Health Daily Briefing

• Secretary Levine reported 543 new cases of COVID-19 yesterday. This is the lowest new case count in Pennsylvania since late March and only about half the number of new cases reported in recent days.  The Secretary warned, however, that case counts can be low the day after a holiday, noting that yesterday was mother’s day.
• Among Pennsylvanians who have been diagnosed with COVID-19, more than 13,000 live or work in 540 long-term-care facilities located in 44 of the state’s 67 counties.
• 3790 health care workers have tested positive for COVID-19.
• Sixty-eight percent of all COVID-19 deaths in the state have been among residents of long-term-care facilities.
• Starting today, Rite Aid is opening nine new drive-through testing sites in eastern Pennsylvania at which people can be tested without charge. These new sites are in addition to six similar Rite Aid sites already operating elsewhere in the state.
• After receiving guidance from the federal Centers for Medicare & Medicaid Services (CMS), the state will begin releasing facility-specific data on COVID-19 cases in long-term-care facilities later this week.
• The Secretary said that the department should have information later this week about a plan for periodic testing at long-term-care facilities.
• The state Department of Health has begun discussing with officials in Philadelphia and its surrounding counties the metrics it might employ to determine when it might be appropriate to begin reopening those areas.
• The state has not yet begun developing criteria for moving counties or regions from the yellow phase to the green phase.

Federal Update

Department of Health and Human Services

• HHS has announced its allocation plan for the distribution of the prescription drug remdesivir to treat patients with COVID-19. The initial shipments were to Connecticut, Illinois, Iowa, Maryland, Michigan, and New Jersey.  The drug is being shipped to state health departments, which will decide how it will be distributed among hospitals.
• HHS will base future distribution of remdesivir on hospitals’ active COVID-19 cases. For this reason, it is asking hospitals log on to the COVID-19 Web Portal at https://teletracking.protect.hhs.gov, using the same login information they recently used to provide year-to-date coronavirus-related admissions.  Once logged in, hospitals are asked to provide the number of currently hospitalized COVID-19 patients, and of those admissions, the number of currently hospitalized patients requiring placement in an intensive care unit as of May 10 or the date they are submitting this data, up to the submission deadline of 8:00 pm ET on Tuesday, May 12.  Hospitals will be asked to provide this information weekly so HHS can adjust to the changing national need for remdesivir.  Hospitals will receive additional information about future submissions later this week.  Find additional help about HHS’s teletracking portal here.

Centers for Medicare & Medicaid Services

• CMS has updated its compendium of information about COVID-19 emergency declaration blanket waivers for health care providers. Changes include:
• Expanded ability for hospitals to offer long-term-care services (swing beds) (p. 7).
• Waiving of certain eligibility criteria for sole-community hospitals (p. 10) and Medicare-dependent hospitals (p. 10).
• Reduced training requirements for long-term-care facility and nursing facility feeding assistants (p. 18).
• Expanded scope of responsibilities for occupational therapists, physical therapists, and speech language pathologists working for home health agencies (p. 19).
• Changes in service delivery requirements for end-stage renal dialysis providers (p. 24).
• Life-safety code waivers for hospitals, skilled nursing facilities, and others (p. 26).

CMS Stakeholder Engagement Calls

CMS COVID-19 Office Hours Calls (Tuesdays and Thursdays at 5:00 – 6:00 PM Eastern)

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 healthcare systems to:

• Increase Hospital Capacity – CMS Hospitals Without Walls;
• Rapidly Expand the Healthcare Workforce;
• Put Patients Over Paperwork; and
• Further Promote Telehealth in Medicare

Tuesday, May 12th at 5:00 – 6:00 PM Eastern

Toll Free Attendee Dial In: 833-614-0820;

Access Passcode: 8968295

Link to live audio webcast

Thursday, May 14th at 5:00 – 6:00 PM Eastern

Toll Free Attendee Dial In: 833-614-0820;

Access Passcode: 5688374

Link to live audio webcast

Lessons from the Front Lines: COVID-19 (Fridays at 12:30 – 2:00 PM Eastern)

Lessons from the Front Lines  calls are a joint effort between CMS Administrator Seema Verma, FDA Commissioner Stephen Hahn, MD, and the White House Coronavirus Task Force. Physicians and other clinicians are invited to share their experience, ideas, strategies, and insights with one another related to their COVID-19 response. There is an opportunity to ask questions of presenters.

This week’s Lessons from the Front Lines:

Friday, May 15th at 12:30 – 2:00 PM Eastern

Toll Free Attendee Dial-In: 877-251-0301;

Access Code: 8983296

Link to live audio webcast

Weekly COVID-19 Care Site-Specific Calls

CMS hosts weekly calls for certain types of organizations to provide targeted updates on the agency’s latest COVID-19 guidance. One to two leaders in the field also share best practices with their peers. There is an opportunity to ask questions of presenters if time allows.

Home Health and Hospice (Tuesdays at 3:00 PM Eastern)

Tuesday, May 12th at 3:00 – 3:30 PM Eastern

Toll Free Attendee Dial-In: 833-614-0820;

Access Passcode: 9503927

Link to live audio webcast

Nursing Homes (Wednesdays at 4:30 PM Eastern)

Wednesday, May 13th at 4:30 – 5:00 PM Eastern

Toll Free Attendee Dial-In: 833-614-0820;

Access Passcode: 2675207

Link to live audio webcast

Dialysis Organizations (Wednesdays at 5:30 PM Eastern)

Wednesday, May 13th at 5:30 – 6:00 PM Eastern

Toll Free Attendee Dial-In: 833-614-0820;

Access Passcode: 6772827

Link to live audio webcast

Nurses (Thursdays at 3:00 PM Eastern)

Thursday, May 14th at 3:00 – 3:30 PM Eastern

Toll Free Attendee Dial-In: 833-614-0820;

Access Passcode: 4279137

Link to live audio webcast

Past Stakeholder Engagement Calls

Find links to audio versions of past stakeholder calls here.

Centers for Disease Control and Prevention

• The CDC has published a list of the 395 hospitals that received payments from $12 billion from the Provider Relief Fund set aside for providers that admitted 100 or more COVID-19 patients through April 10.
• The CDC has updated its interim guidance and resources for laboratory professionals working with specimens from persons under investigation for COVID-19.
• The CDC has posted an overview of its SARS-Co-V-2 Sequencing for Public Health Emergency, Epidemiology, and Surveillance (SPHERES) program, a new national genomics consortium to coordinate COVID-19 sequencing across the country.
• The CDC has updated its guidance and resources for COVID-19 contact tracing.
• The CDC has updated its FAQ on COVID-19 and children.

Food and Drug Administration

• The FDA has published a fact sheet on the use of remdesivir.
• The FDA has updated its policy for COVID-19 tests during the public health emergency. The policy, for clinical laboratories, commercial manufacturers, and FDA staff, seeks to help accelerate the availability of COVID-19 tests developed by laboratories and commercial manufacturers.
• The FDA has issued an emergency use authorization (EUA) for the first antigen test to help in the rapid detection of the virus that causes COVID-19.
• The FDA has issued an EUA for a specific commercial system for use by providers for temporary isolation and transport of patients with suspected or confirmed COVID-19.
• The FDA has issued an EUA for emergency use of a specific prescription drug to maintain sedation via continuous infusion in adult patients who require ventilation for COVID-19.
• The FDA has issued EUAs for three specific commercial tests for COVID-19. Find those EUAs here, here, and here.

Department of Labor

The Department of Labor has provided additional guidance to states on the federal pandemic unemployment compensation program. See its announcement and explanation here and the formal guidance itself 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.)

COVID-19 update for Friday, May 8 as of 2:30 p.m.

Pennsylvania Update

Governor Wolf

• Governor Wolf announced that 13 more counties in southwestern Pennsylvania, including Allegheny County, will move to the yellow phase and be permitted to reopen partially next Friday, May 15.
• Yesterday Governor Wolf extended his stay-at-home order for counties in the COVID-19 red phase until June 4 and issued an executive order for counties in the yellow phase that began reopening today.
• The state also issued guidance for businesses in the yellow phase that are permitted to reopen and updated guidance for life-sustaining businesses.

Department of Human Services

• DHS sent a message to all county administrators of Medical Assistance Transportation Programs, brokers for those programs, and contracted transit agencies working for the program advising of the precautions necessary to ensure the safe provision of non-emergency medical transportation services during the COVID-19 emergency.
• DHS has announced to users of its Medical Assistance Transportation Program that use of the program is limited during the COVID-19 emergency. The announcement addresses the circumstances under which program participants will or will not be permitted to use the service, what they need to do to use the service, and what they need to do if they are not permitted to use the service in the usual manner.
• DHS has issued guidance to health care providers to remind them that non-emergency ambulance transportation may be used when medically necessary to transport Medicaid beneficiaries in the fee-for-service and HealthChoices programs to medical appointments when transportation through the Medical Assistance Transportation Program is not available or appropriate based on COVID-19 screening criteria. See those screening criteria here.

Department of Health

The Department of Health has posted an application for nursing homes to request civil money penalty reinvestment funds to purchase adaptive technologies such as iPads, tablets, webcams, and accessories to facilitate virtual and social telehealth visits between residents and their families while visitor restrictions are in place.  See an FAQ prepared by CMS here.

Department of Health Daily Briefing

• Between the continued reconciliation of recent death data and new deaths, the state reported an increase of 200 deaths from COVID-19. This brings the state-wide total to 3616.
• Continued death data reconciliation and new cases have raised Pennsylvania’s total deaths from COVID-19 nearly 50 percent in the past week.
• Nearly 11,000 long-term-care facility residents and more than 1500 people who work at 522 such facilities in 44 counties have tested positive for COVID-19.
• Long-term-care facility residents currently account for 68 percent of all COVID-19 deaths state-wide.
• More than 3500 health care workers have been diagnosed with COVID-19.

Department of State

The Department of State has published a notice that it will permit students about to graduate from physical therapist and physical therapist assistant programs during the COVID-19 emergency to take their licensure examination before they graduate.

General Assembly

The Senate will be in session on May 11, 12, and 13.  The House is not expected to return to session until May 18.

Federal Update

Department of Health and Human Services

• HHS has updated its general distribution FAQ for the CARES Act Provider Relief Fund. The updated FAQ includes items that are identified as new.  Among other things, it clarifies that HHS will not generally seek to recoup payments as long as providers’ lost revenue and increased expenses are greater than any payments in question.  The FAQ also instructs hospitals on what they should do if they believe they received a mistaken payment or an overpayment.
• HHS’s Office of the Inspector General has updated its FAQ on how it will apply its administrative enforcement authority to arrangements directly connected to the COVID-19 emergency. The new guidance specifically outlines conditions under which a clinical lab could offer remuneration to a retail pharmacy for costs incurred running test sites during the COVID-19 emergency.

Centers for Medicare & Medicaid Services

• CMS has added the QW modifier to Healthcare Common Procedure Coding System (HCPCS) codes U0002 and 87635, both of which involve testing for COVID-19. The notice is relevant for labs that have a current Clinical Laboratory Improvement Amendments (CLIA) certificate of waiver and bill for Medicare services.
• CMS has posted a video with answers to common questions about the expanded Medicare telehealth services benefit under the 1135 waiver authority and Coronavirus Preparedness and Response Supplemental Appropriations Act.
• CMS has published a notice that Medicare pharmacies and other suppliers may temporarily enroll as independent clinical diagnostic laboratories to help address COVID-19 testing.
• In the past week CMS issued six section 1135 waivers to give states greater flexibility to serve their Medicaid beneficiaries during the COVID-19 emergency. The states receiving waivers this week are Arizona, Arkansas, Iowa, Maryland, New York, and Washington.

Food and Drug Administration

• The FDA has posted a letter to caregivers warning that certain respirators from China may not provide adequate protection. The letternotes that the FDA has reissued its emergency use authorization (EUA) for non-NIOSH-approved disposable filtering facepiece respirators manufactured in China to revise one of the eligibility criteria and includes a link to an updated list of authorized respirators.
• The FDA has issued an EUA for a specific commercial product for use in decontaminating compatible N95 or N95-compatible respirators.
• The FDA has issued a warning to health care providers about the risk of misinterpreting hydrogen peroxide indicator colors for vapor sterilization. During the COVID-19 epidemic, the FDA warns, “…health care facilities are rapidly adopting conservation practices, including decontaminating disposable compatible N95 and N95-equivalent respirators for single-user reuse.  Reprocessing staff may be using sterilization systems for the first time or concurrently using sterilization systems from different manufacturers.  If staff assume that all manufacturers use the same color code to validate sterilization, they may mistakenly release contaminated devices for reuse.”
• The FDA has issued an EUA for a specific commercial diagnostic test for COVID-19 that is the first authorized use of CRISPR technology for an infectious disease test.
• The FDA has issued an EUA for the first diagnostic test for COVID-19 using at-home collection of saliva specimens.
• The FDA has issued four EUAs for specific commercial diagnostic tests for COVID-19. Find them here, here, here, and here.

Centers for Disease Control and Prevention

• The CDC has issued guidance on how laboratories, including hospital laboratories, should report the results of their COVID-19 testing to their local or state health department. The guidance includes specific information about the formats and codes labs should use when submitting their data.

National Institutes of Health

• The NIH announced that clinical trial testing has begun on antiviral remdesivir plus the anti-inflammatory drug baricitinib for COVID-19. The trial is now enrolling hospitalized adults and is expected to be undertaken at approximately 100 U.S. and international sites and involve more than 1000 participants.
• The NIH announced its collaboration on a research survey to examine the impact of COVID-19 on rare diseases communities.

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

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

COVID-19 update for Thursday, May 7 as of 2:30 p.m.

Pennsylvania Update

General Assembly

The House canceled its plan to meet next week, on May 11, 12, and 13, and has added May 18, 19, 20, 26, and 27 to its legislative calendar.  The Senate is scheduled to return to session on May 18.

Department of Human Services

• DHS has posted a notice rescinding prior guidance on elective services.  This has been done to reflect the phased reopening of Pennsylvania and its health care system and updated guidance for hospitals and guidance for ambulatory surgical facilities from the Department of Health based on that reopening.
• DHS has sent a similar message to the managed care organizations that participate in the state’s HealthChoices physical health program.
• DHS has sent a memo to the managed care organizations that participate in the state’s Children’s Health Insurance Program (CHIP) informing them that unemployment income must be calculated for a 39-week period when determining eligibility for CHIP for the duration of the COVID-19 emergency.

Governor Wolf

Governor Wolf has signed an executive order giving health care practitioners protection against liability for good faith actions taken in response to the call to supplement the health care provider workforce during the COVID-19 pandemic.  HAP and the PA Chamber of Commerce and Industry are calling for the protection to be expanded to institutional health care providers.

Governor Wolf has signed an executive order protecting businesses and individuals whose livelihood has been disrupted by COVID-19 from foreclosures or evictions through July 10.

The governor has announced the formation of a volunteer think tank to “…strategize how to heal the trauma that all Pennsylvanians are experiencing due to the COVID-19 pandemic.”  This marks an expansion of the group’s original scope of work, introduced last July, which was to advise the state government on policies that are sensitive to the needs of individuals who have suffered traumatic experiences.

Department of Health

The Department of Health has posted an FAQ for families of nursing care facility staff and residents.

Department of Health Daily Briefing

• As part of its continuing reconciliation of data, the Department of Health added more than 300 people to its total of deaths from COVID-19.
• Among Pennsylvanians who have tested positive from COVID-19, 3437 are health care workers (including nursing home staff), 2107 are food industry workers, and more than 10,000 reside in 514 long-term-care facilities.
• 2484 Pennsylvanians are currently hospitalized for COVID-19 and 528 are on ventilators.
• 45 percent of the state’s acute-care beds and 39 percent of its ICU beds are currently unoccupied and 73 percent of its ventilators are idle.
• Governor Wolf said the state will announce more county/regional openings tomorrow.
• The state is looking at various Bluetooth technologies to facilitate contact tracing and is now working on a contract for such technology.

Federal Update

Department of Health and Human Services Provider Relief Fund

• HHS has extended the deadline for attestation and acceptance of terms and conditions for payments from the Provider Relief Fund from the current 30 days to 45 days.
• HRSA, which is administering the program through which providers can submit claims for COVID-19-related care they provide to uninsured patients, has posted an FAQ based on a webinar it held last week to address how providers can submit those claims.
• HRSA also has posted a video demonstrating how to add and attest to the patient roster on the portal for submitting claims for COVID-19 care for the uninsured.

Department of Health and Human Services

HHS’s Office of the Assistant Secretary for Preparedness and Response’s Technical Resources Assistance Center and Information Exchange will hold a webinar titled “COVID-19:  Healthcare System Operations Strategies and Experiences” next Monday, May 11 at 2:00 p.m. (eastern) to help health systems incorporate experiences and lessons learned from hospitals in New York, Louisiana, and Arizona that have been hit especially hard by COVID-19.  Find information about the webinar here.

Health Resources and Services Administration

HRSA has awarded nearly $583 million to 1385 HRSA-funded health centers in all 50 states.  The primary purpose of this funding is to expand COVID-19 testing.  See HRSA’s announcement here and an interactive map showing award recipients here.

Centers for Medicare & Medicaid Services

• CMS has issued an interim final rule updating requirements for notification of confirmed and suspected COVID-19 cases among residents and staff in nursing homes.  In the guidance, nursing homes are directed to report COVID-19 data to the CDC and the residents of nursing homes and their families and representatives.
• CMS has posted an updated list of lab test codes for COVID-19, influenza, and respiratory syncytial virus (RSV).

Centers for Disease Control and Prevention

• The CDC has updated its FAQ for infection prevention and control in health care settings.
• The CDC has created a web page to share information about its own COVID-19 serology test and its possible future uses.
• The CDC has posted guidance for cleaning and disinfecting public spaces, workplaces, businesses, schools, and homes.
• The CDC also has published separate reopening guidance for cleaning and disinfecting public spaces, workplaces, businesses, schools, and homes.

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.)