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.)

COVID-19 update for Wednesday, May 6 as of 3:00 p.m.

Pennsylvania Update

Governor Wolf

• The Wolf administration announced that it is establishing a facility in Delaware County that has the capacity to decontaminate “tens of thousands” of N95 respirators a day.  The equipment has been provided by the U.S. Department of Health and Human Services, the service is free, and among those eligible to use this service are health care facilities, first responders, and others, such as hospitals, urgent care centers, nursing homes, rehabilitation facilities, cancer centers, pharmacies, dialysis centers, assisted living facilities, clinical laboratories, emergency medical services, private practice/outpatient facilities, first responder organizations, and others.  Interested organizations must register and information will be available through the Pennsylvania Department of Health, the Pennsylvania Emergency Management Agency, the Hospital and Healthsystem Association of Pennsylvania, and others.  Read the Wolf administration’s announcement here.
• Governor Wolf announced the creation of a new Commonwealth Civilian Coronavirus Corps to “…support efforts this fall to increase testing and contact tracing and provide critical new job opportunities in the public health sector.”  Learn more from the Wolf administration’s announcement, which includes a description of the anticipated areas of endeavor of the new organization.

Department of Human Services

• DHS has circulated a survey requesting detailed information about the financial impact of COVID-19 on hospitals.  It requests responses by May 20.

• DHS’s Office of Mental Health and Substance Abuse Services has issued a bulletin with instructions for the delivery of behavioral health rehabilitation services and licensed intensive behavioral health services to Medicaid beneficiaries via telehealth during the COVID-19 emergency.  The bulletin applies to providers enrolled in the state’s fee-for-service and managed care delivery systems, including primary contractors and behavioral health managed care organizations in the HealthChoices program.
• The Office of Mental Health and Substance Abuse Services has issued a supplemental FAQ about the delivery of Medicaid-covered behavioral health services during the COVID-19 crisis.  This new FAQ supplements a previous FAQ issued on March 25.
• The Office of Mental Health and Substance Abuse Services also has issued a memorandum to clarify the ability of providers to use telehealth to provide behavioral health services to Medicaid beneficiaries.  The memo notes that the office is temporarily suspending certain requirements that otherwise govern the provision of behavioral health services using telehealth.
• DHS’s Office of Long-Term Living has published clarification of visitation restrictions in personal care homes and assisted living residences.  This clarification supplements guidance issued on March 29 to explain that the March 29 guidance does not restrict medically necessary visits from essential health care personnel.

Department of Health

The Department of Health has issued a message to its Health Alert Network to reflect that among the various types of COVID-19 tests available, the federal Food and Drug Administration has now authorized some serology tests.

Department of Health Daily Briefing

• Governor Wolf and Secretary Levine participated in today’s briefing.
• The governor discussed the new Commonwealth Civilian Coronavirus Corps and said he will provide further information about it in the near future.
• Secretary Levine reported that among the more than 50,000 cases of COVID-19 in the state, more than 3300 are health care workers, more than 2000 work in the food industry in 122 establishments, and more than 10,000 reside in long-term-care facilities.
• 2553 COVID-patients are currently hospitalized and 549 are on ventilators.
• Today marked the fourth straight day of new case counts under 1000, a point that the Secretary described as potentially signifying a promising trend.
• 46 percent of the state’s acute-care beds and 40 percent of its ICU beds are currently unoccupied and nearly 75 percent of its ventilators are idle.
• Governor Wolf described the N95 mask decontamination facility in Delaware County.
• The governor said his administration is not discussing giving civil liability immunity to long-term-care facilities but is discussing some protections for some other health care providers.
• The state’s overall testing numbers are down, the governor said, because as long as the criteria for testing remains showing symptoms of COVID-19 and the number of cases in the state declines, the number of tests administered declines along with it.
• The state wants to expand testing, Secretary Levine elaborated, especially in southeastern and northeastern Pennsylvania.  It also hopes to engage in some population-based and surveillance testing, especially in the parts of the state that are reopening, at which time the number of tests performed in the state will increase significantly.

Federal Update

Department of Health and Human Services/Health Resources and Services Administration

• HHS’s Health Resources and Services Administration, which is administering the program through which providers can be reimbursed for COVID-19-related services they provide to uninsured patients, has posted information on how to batch enter patient roster information.
• HRSA has posted a list of billing vendors and clearinghouses that have committed to submitting claims as part of the program for providers to seek payment for care provided to uninsured COVID-19 patients.
• HRSA has posted information about timing expectations for COVID-19 claims processing.

Department of Health and Human Services/Office of Civil Rights

• HHS’s Office of Civil Rights has issued guidance to remind covered health care providers that HIPAA does not permit them to give media and film crews access to facilities where patients’ protected health information will be accessible without patients’ prior authorization.  The guidance clarifies that masking or obscuring patients’ faces or identifying information before broadcasting a recording of a patient is not sufficient to satisfy HIPAA requirements.

Centers for Disease Control and Prevention

• The CDC has published a report, “Evidence Supporting Transmission of Severe Acute Respiratory Syndrome Coronavirus 2 While Presymptomatic or Asymptomatic,” that supports the possibility of people who are presymptomatic or asymptomatic for COVID-19 transmitting the disease to others.
• The CDC has posted a guide on the differences between isolation and quarantine for COVID-19.

Food and Drug Administration

• The FDA has approved two generic drugs indicated 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 a specific laboratory’s test for detecting COVID-19.
• The FDA has issued an EUA for a specific commercial product to be used in hospitals for remote monitoring and detection of changes in the QT interval of electrocardiograms in adult patients being treated for COVID-19.

Department of Labor

• The Labor Department has announced that Dislocated Worker Grant funding made available to states and territories to employ workers temporarily to respond to the COVID-19 emergency can be used for contact tracing.  States must apply for these grants.
• The Department of Labor’s Occupational Safety and Health Administration (OSHA) has released a new video and poster for employees and workers on how to properly wear and remove a respirator.

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 5 as of 3:00 p.m.

Pennsylvania Update

Governor Wolf:  Reopening Pennsylvania

Governor Wolf has provided guidance to businesses as 24 counties move to the “yellow phase” of reopening beginning this Friday, May 8.  The guidance details procedures businesses must follow to conduct in-person operations.  See the administration’s announcement of the guidance here and go here for the guidance itself.

Department of Human Services

• During its April 29 COVID-19 webinar, DHS officials explained that the department has accelerated certain capitation payments to Medicaid MCOs.  This action will enable the advance in appendix 14 and appendix 17 payments described previously, which are expected to be distributed to hospitals on June 4.
• During that same webinar, DHS officials also discussed a recent change in prior authorization requirements for long-term acute hospital admissions.
• DHS’s Office of Medical Assistance Programs has updated its FAQ about coverage of COVID-19 testing and related services for participants in the state’s CHIP program.

Department of Health

The Department of Health has published interim guidance on conditions and circumstances for discontinuing non-health care isolation for persons with COVID-19.

The department has written to the leaders of hospitals, health care facilities, and laboratories asking them to complete a survey that will be used by the state to determine Pennsylvania’s current capacity for administering COVID-19 tests.  See the letter here and the survey here.

Department of Health Daily Briefing

• After reconciling death count data over the past two weeks, including data from Philadelphia, the state has added 554 new deaths to its total count.  This raises the total death count nearly 23 percent over yesterday’s announced total.
• Among the nearly 51,000 Pennsylvanians who have been diagnosed with COVID-19 are 3200 health care workers, more than 9600 residents of long-term-care facilities, and more than 2000 workers in food processing facilities.
• 2583 Pennsylvanians are currently hospitalized with COVID-19 and 542 of them are on ventilators.
• 46 percent of the state’s acute-care hospital beds and 40 percent of its ICU vents are unoccupied and nearly 75 percent of its ventilators are idle.
• Secretary Levine told a legislative committee that the state would not provide personal protective equipment to hospitals that have resumed performing non-urgent procedures because one of the conditions for resuming such procedures is having an adequate supply of such materials.

Federal Update

Centers for Medicare & Medicaid Services

• CMS has updated its FAQ for state Medicaid and CHIP programs.  Among the issues the FAQ addresses are emergency preparedness and response, eligibility and enrollment flexibilities, benefit flexibilities, cost-sharing flexibilities, financing flexibilities, managed care flexibilities, information technology and  data reporting.  A separate document includes only the new questions.

Centers for Disease Control and Prevention

• The CDC has posted guidance for nasal (anterior nasal) specimen collection for COVID-19 diagnostic testing.
• The CDC has updated its interim guidance for collecting, handling, and testing clinical specimens from persons with COVID-19.
• The CDC has updated its strategies for optimizing supplies of personal protective equipment.
• The CDC has posted general guidance for handling bulk-packaged sterile swabs properly for upper respiratory sample collection during the COVID-19 crisis.
• The CDC has posted guidance for proposed use of point-of-care testing platforms for COVID-19.

Food and Drug Administration

• The FDA has updated its policy on the review and approval of diagnostic and antibody tests for COVID-19.  In a commentary titled “Insight Into FDA’s Revised Policy on Antibody Tests for COVID-19,” FDA officials explain the evolution of the agency’s approach to issuing emergency use authorizations for antibody tests.  The new policy itself can be found here.
• The FDA has issued emergency use authorizations (EUA) for two specific commercial diagnostic tests for COVID-19.  See them here and here.

Medicaid Health Plans of America

• Medicaid Health Plans of America, a trade association that represents more than 90 Medicaid managed care plans serving Medicaid beneficiaries in 37 states, has written to leaders of Congress to ask that they increase the federal medical assistance percentage (FMAP), the rate at which the federal government matches state Medicaid expenditures, by 12 percent retroactive to January 1, 2020 and through September 30, 2021.  The group also asked Congress to delay or cancel CMS’s Medicaid fiscal accountability regulation (MFAR).

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 4 as of 2:30 p.m.

Pennsylvania Update

Department of Health

The Department of Health has issued an advisory on the criteria for the discontinuation of transmission-based precautions for patients with COVID-19.

The department has issued an update on its criteria for health care personnel returning to work after confirmed or suspected COVID-19.  The advisory includes extending the amount of time such personnel need to be excluded from work after the first symptoms arise.

The department has posted an alert reminding health care providers that only labs with CLIA certification can perform COVID-19 tests, that only molecular and serology tests have been authorized by the FDA, and providing additional clarifications.  It also offers a graphic depiction of COVID-19 testing requirements.

Department of Health Daily Briefing

• With 825 new cases yesterday, Pennsylvania has surpassed 50,000 people diagnosed with COVID-19.  2500 of them have passed away.
• Of the 50,000 cases, 3100 are health care workers and more than 9300 reside in long-term-care facilities.
• 2689 people are currently hospitalized with COVID-19; among them, 553 are on ventilators.
• 46 percent of the state’s acute-care beds and 40 percent of its ICU beds are currently unoccupied and nearly 75 percent of its ventilators are now idle.
• The process of reviewing counties and regions for eligibility to reopen will be conducted on a continual basis as new data becomes available.
• Secretary Levine believes that if mitigation measures are reduced that case counts will rise.
• She believes the strategy the state has been employing has been appropriate.
• She said the state is still not getting the data on race that it needs to perform a more complete analysis of the impact of COVID-19.
• The Department of Health is working on guidance for dental practices and hopes to have that guidance by the end of the week.
• State officials are still discussing whether to share data with the public on cases and deaths in individual long-term-care facilities.
• The death counts Philadelphia announces and those the state announces for Philadelphia continue to disagree.  The two jurisdictions use different data systems and are working to reconcile the differences between those systems.
• With another outbreak predicted for later this year, Secretary Levine said that one of the major lessons the state has learned, and that it should apply in the future, is to seek to be able to do more testing, especially at the point of care and with a faster turnaround time for results.

Department of Human Services

DHS has issued a Medical Assistance Bulletin adding COVID-19 lab test codes to the Medicaid program fee schedule.

DHS has issued a Medical Assistance Bulletin adding the multi-function ventilator to the Medicaid program fee schedule.

DHS has issued a Medical Assistance Bulletin on COVID-19 testing and related treatments that are exempt from Medicaid copayment requirements.

DHS has issued a Medical Assistance Bulletin to advise providers that certain non-physician practitioners may prescribe home health services and medical supplies, equipment, and appliances effective March 1.

DHS’s Office of Long-Term Living has posted a notice presenting a new way to certify people to administer insulin injections in long-term-care facilities that may have a shortage of qualified staff to perform this task.

Federal Update

Department of Health and Human Services

• Last Friday HHS began processing $22 billion in payments from the CARES Act’s provider relief fund to hospitals with large numbers of COVID-19 admissions through April 10 and to rural providers in support of the national response to COVID-19.  See HHS’s announcement of the distribution of this money, including a breakdown by state of grant recipients.

Centers for Medicare & Medicaid Services

• CMS has posted a presentation that elaborates on the regulatory changes the agency introduced last week.  It includes explanations of how to interpret the new regulation’s flexibilities and offers examples of how health systems can expand services.
• In response to the increased need for providing telehealth due to COVID-19, CMS has given additional consideration to telehealth services in HHS-operated risk adjustment for issuers in the individual and small group health insurance markets inside and outside the marketplaces.  In new guidance, CMS clarifies which telehealth services are valid for HHS-operated risk adjustment data submission in light of the COVID-19 pandemic.
• CMS has published CARES Act financial guidance to state survey agencies for the award and administration of supplemental funding for the cost of survey and certification efforts with a focus on areas where there is community spread of COVID-19.  This funding is expected to be used to complete focused infection control surveys for nursing homes, to increase complaint surveys, and to perform reopening surveys of facilities with previous COVID-19 outbreaks.
• CMS has updated its COVID-19 FAQ on Medicare fee-for-service billing.

CMS Stakeholder Calls

Centers for Disease Control and Prevention

• The CDC has updated its FAQ on COVID-19 testing at laboratories.
• The CDC has updated information about its Coronavirus Disease-Associated Hospitalization Surveillance Network, a population-based surveillance system that collects data on laboratory-confirmed COVID-19-associated hospitalizations among children and adults through a network of over 250 acute-care hospitals in 14 states.
• The CDC has updated its interim guidance on health care workers returning to work after confirmed or suspected COVID-19.
• The CDC has issued a lab advisory with additional guidance on COVID-19 laboratory testing.
• The CDC has updated its guidance on COVID-19 evaluation and testing.
• The CDC has updated its clinical care guidance for health care professionals about COVID-19.
• The CDC has updated its interim guidance on the discontinuation of home isolation for persons with COVID-19, including increasing the length of recommended time for home isolation.
• The CDC has updated its guidance on the care of children with COVID-19.
• The CDC has launched a national viral genomics consortium to better map COVID-19 transmission.
• The CDC has updated its page collecting contact tracing training guidance and resources.
• The CDC has updated its interim guidance for the collection and submission of post-mortem specimens from deceased persons under investigation for COVID-19.

Food and Drug Administration

• The FDA has approved an emergency use authorization (EUA) for the use of the investigational anti-viral drug remdesivir for the treatment of suspected or confirmed COVID-19.
• The FDA has issued guidance to provide recommendations to health care providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 during the public health emergency.  The guidance also provides recommendations to blood establishments on the collection of COVID-19 convalescent plasma.
• The FDA has approved EUAs for four new COVID-19 tests (here, here, here, and here ) and three new COVID-19 serology tests (here, here, and here).
• The FDA has issued an EUA for a specific commercial respiratory muscle ventilator to be used to reduce atrophy of the abdominal walls among COVID-19 patients who require mechanical ventilation.
• The FDA has sent a letter to manufacturers of protective barrier enclosures, health care providers, and other stakeholders outlining the characteristics it will be looking for when considering issuing EUAs for protective barrier enclosures to help protect health care personnel caring for confirmed or suspected COVID-19 patients.
• The FDA has issued an EUA for a specific commercial product used to provide continuous renal replacement therapy to treat patients in an acute-care environment during the COVID-19 crisis.

Department of Labor

• The Department of Labor has issued additional guidance about 100 percent federal reimbursement of certain state short-term compensation payments and other changes in short-term compensation programs.  The guidance seeks to address “…how states can take advantage of this program as they look to re-open their businesses.”  For further information see the department’s news release and its official unemployment insurance program letter.

National Institutes of Health

• The NIH has launched its study to determine the incidence of COVID-19 in children.

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, April 30 as of 4:00 p.m.

Pennsylvania Update

Governor Wolf

Earlier this month the state launched a $450 million Hospital Emergency Loan Program to provide short-term loans to hospitals struggling financially with their response to the COVID-19 emergency.  Today the Wolf administration announced that it has provided $324 million in loans from this fund to 31 Pennsylvania hospitals.  The news release includes a link to a list of loan recipients.

Department of Health

The Department of Health and Pennsylvania Emergency Management Agency have updated their guidance on the distribution of state-acquired personal protective equipment to reflect the state’s current priorities when deciding on the distribution of such materials.  According to the new guidance, the state’s current priority is “…congregate care settings with an identified and investigated need.”  Hospitals, the latest guidance explains, “…will no longer receive PPE directly from the commonwealth.”

Department of Health Daily Briefing

• The number of new cases increased again yesterday.
• Among those who have tested positive for COVID-19 in Pennsylvania, 2753 are health care workers and 8112 reside in 468 long-term-care facilities.
• 2706 people are currently hospitalized with COVID-19 and 562 of them are on ventilators.  The latter is a decline of about 100 in the past week.
• 40 percent of the state’s acute-care beds and 40 percent of its ICU beds are currently unoccupied and 70 percent of its ventilators are idle.
• Since the start of the pandemic, the state has made 1378 shipments of personal protective equipment to providers and institutions.  This includes more than four million N95 respirators, 241,000 hospital gowns, 1.3 million surgical masks, 1.3 million pairs of gloves, and 80,000 face shields.
• Pennsylvania’s stay-at-home order remains in effect.
• If and when some counties or regions are declared “yellow” and targeted for partial reopening, some businesses will remain closed.  The state will provide more information about this tomorrow.
• Testing is still not being done for those without symptoms but is being expanded for those with symptoms of COVID-19, including those with just mild symptoms.
• The state is still collecting and reconciling death data so there could be another spike in the death count in the future.
• The capacity to perform tests around the state has expanded.
• Hospitals will be testing patients before they undergo elective procedures.

Federal Update

Major New Regulation From CMS

CMS this afternoon published a 279-page interim final rule with comment period covering Medicare and Medicaid, the Basic Health Program, and additional policy and regulatory revisions in response to the COVID-19 emergency and delaying certain reporting requirements for the skilled nursing facility quality reporting program.  The CMS news release announcing the policy changes describes them as a “…round of sweeping regulatory waivers and rule changes to deliver expanded care to the nation’s seniors and provide flexibility to the healthcare system as America reopens.  These changes include making it easier for Medicare and Medicaid beneficiaries to get tested for COVID-19 and continuing CMS’s efforts to further expand beneficiaries’ access to telehealth services.”

If you would like to explore the changes, you can do so through the following resources:

• the CMS news release announcing the changes
• the document COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers, which includes the policy changes
• the posted interim final rule itself

As of this writing we believe the following are the highlights, which are taken directly from CMS’s compendium document on blanket waivers and from the interim final rule posted today.

Flexibility for Medicare Telehealth Services

• “When a registered outpatient of the hospital is receiving a telehealth service, the hospital may bill the originating site facility fee to support such telehealth services furnished by a physician or practitioner who ordinarily practices there.”
• CMS is increasing reimbursement for the audio-only E/M codes 99441-99443 that were temporarily recategorized as reimbursable under the last IFC.  Reimbursement for CPT Codes 98966-98968 is not being increased.  CMS describes the revised RVUs for these codes as follows:
• “Specifically, we are crosswalking CPT codes 99212, 99213, and 99214 to 99441, 99442, and 99443 respectively. We are finalizing, on an interim basis and for the duration of the COVID-19 PHE the following work RVUs: 0.48 for CPT code 99441; 0.97 for CPT code 99442; and 1.50 for CPT code 99443. We are also finalizing the direct PE inputs associated with CPT code 99212 for CPT code 99441, the direct PE inputs associated with CMS-5531-IFC 140 CPT code 99213 for CPT code 99442, and the direct PE inputs associated with CPT code 99214 for CPT code 99443.”
• Eligible Practitioners. Pursuant to authority granted under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) that broadens the waiver authority under section 1135 of the Social Security Act, the Secretary has authorized additional telehealth waivers. CMS is waiving the requirements of section 1834(m)(4)(E) of the Act and 42 CFR § 410.78 (b)(2) which specify the types of practitioners that may bill for their services when furnished as Medicare telehealth services from the distant site. The waiver of these requirements expands the types of health care professionals that can furnish distant site telehealth services to include all those that are eligible to bill Medicare for their professional services. This allows health care professionals who were previously ineligible to furnish and bill for Medicare telehealth services, including physical therapists, occupational therapists, speech language pathologists, and others, to receive payment for Medicare telehealth services.
• Audio-Only Telehealth for Certain Services. Pursuant to authority granted under the CARES Act, CMS is waiving the requirements of section 1834(m)(1) of the ACT and 42 CFR § 410.78(a)(3) for use of interactive telecommunications systems to furnish telehealth services, to the extent they require use of video technology, for certain services. This waiver allows the use of audio-only equipment to furnish services described by the codes for audio-only telephone evaluation and management services, and behavioral health counseling and educational services (see designated codes https://www.cms.gov/Medicare/MedicareGeneral-Information/Telehealth/Telehealth-Codes). Unless provided otherwise, other services included on the Medicare telehealth services list must be furnished using, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician or practitioner.

Physician Services

• Quality Assurance and Performance Improvement (QAPI). (New since 4/21 Release) CMS is modifying certain requirements in 42 CFR §483.75, which requires long-term care facilities to develop, implement, evaluate, and maintain an effective, comprehensive, data-driven QAPI program. Specifically, CMS is modifying §483.75(b)–(d) and (e)(3) to the extent necessary to narrow the scope of the QAPI program to focus on adverse events and infection control. This will help ensure facilities focus on aspects of care delivery most closely associated with COVID-19 during the PHE.
• In-Service Training: (New since 4/21 Release) CMS is modifying the nurse aide training requirements at §483.95(g)(1) for SNFs and NFs, which requires the nursing assistant to receive at least 12 hours of in-service training annually. In accordance with section 1135(b)(5) of the Act, we are postponing the deadline for completing this requirement throughout the COVID-19 PHE until the end of the first full quarter after the declaration of the PHE concludes.
• Detailed Information Sharing for Discharge Planning for Long-Term Care (LTC) Facilities. (New since 4/21 Release) CMS is waiving the discharge planning requirement in §483.21(c)(1)(viii), which requires LTC facilities to assist residents and their representatives in selecting a post-acute care provider using data, such as standardized patient assessment data, quality measures and resource use. This temporary waiver is to provide facilities the ability to expedite discharge and movement of residents among care settings. CMS is maintaining all other discharge planning requirements, such as but not limited to, ensuring that the discharge needs of each resident are identified and result in the development of a discharge plan for each resident; involving the interdisciplinary team, as defined at 42 CFR §483.21(b)(2)(ii), in the ongoing process of developing the discharge plan address the resident’s goals of care and treatment preferences.
• Clinical Records. (New since 4/21 Release) Pursuant to section 1135(b)(5) of the Act, CMS is modifying the requirement at 42 CFR §483.10(g)(2)(ii) which requires long-term care (LTC) facilities to provide a resident a copy of their records within two working days (when requested by the resident). Specifically, CMS is modifying the timeframe requirements to allow LTC facilities ten working days to provide a resident’s record rather than two working days.

Medical Education

• Hospitals may expand their number of beds without affecting their resident to bed ratios for IME (they will use the ratio from before the public health emergency) and , in a significant departure from normal policy, residency programs can count time of residents sent to other hospitals.
• On an interim basis for the duration of the PHE for the COVID-19 pandemic, the teaching physician may not only direct the care furnished by residents, but also review the services provided with the resident, during or immediately after the visit, remotely through virtual means via audio/video real time communications technology.

Home Health

• 12-hour Annual In-Service Training Requirement for Home Health Aides. (New since 4/21 Release) CMS is modifying the requirement at 42 C.F.R. §484.80(d) that home health agencies must assure that each home health aide receives 12 hours of in-service training in a 12-month period. In accordance with section 1135(b)(5) of the Act, we are postponing the deadline for completing this requirement throughout the COVID-19 PHE until the end of the first full 17 04/29/2020 quarter after the declaration of the PHE concludes. This will allow aides and the registered nurses (RNs) who teach in-service training to spend more time delivering direct patient care and additional time for staff to complete this requirement.
• Detailed Information Sharing for Discharge Planning for Home Health Agencies.  (New since 4/21 Release) CMS is waiving the requirements of 42 CFR §484.58(a) to provide detailed information regarding discharge planning, to patients and their caregivers, or the patient’s representative in selecting a post-acute care provider by using and sharing data that includes, but is not limited to, (another) home health agency (HHA), skilled nursing facility (SNF), inpatient rehabilitation facility (IRF), and long-term care hospital (LTCH) quality measures and resource use measures. o This temporary waiver provides facilities the ability to expedite discharge and movement of residents among care settings. CMS is maintaining all other discharge planning requirements.
• Clinical Records: (New since 4/21 Release) In accordance with section 1135(b)(5) of the Act, CMS is extending the deadline for completion of the requirement at 42 CFR §484.110(e), which requires HHAs to provide a patient a copy of their medical record at no cost during the next visit or within four business days (when requested by the patient). Specifically, CMS will allow HHAs ten business days to provide a patient’s clinical record, instead of four.

Home Health and Hospice

• Training and Assessment of Aides: (New since 4/21 Release) CMS is waiving the requirement at 42 CFR §418.76(h)(2) for Hospice and 42 CFR §484.80(h)(1)(iii) for HHAs, which require a registered nurse, or in the case of an HHA a registered nurse or other appropriate skilled professional (physical therapist/occupational therapist, speech language pathologist) to make an annual onsite supervisory visit (direct observation) for each aide that provides services on behalf of the agency. In accordance with section 1135(b)(5) of the Act, we are postponing completion of these visits. All postponed onsite assessments must be completed by these professionals no later than 60 days after the expiration of the PHE.
• Quality Assurance and Performance Improvement (QAPI). (New since 4/21 Release) CMS is modifying the requirement at 42 CFR §418.58 for Hospice and §484.65 for HHAs, which requires these providers to develop, implement, evaluate, and maintain an effective, ongoing, hospice/HHA-wide, data-driven QAPI program. Specifically, CMS is modifying the requirements at §418.58(a)–(d) and §484.65(a)–(d) to narrow the scope of the QAPI program to concentrate on infection control issues, while retaining the requirement that remaining activities should continue to focus on adverse events. This modification decreases burden associated with the development and maintenance of a broad-based QAPI program, allowing the providers to focus efforts on aspects of care delivery most closely associated with COVID-19 and tracking adverse  events during the PHE. The requirement that HHAs and hospices maintain an effective, ongoing, agency-wide, data-driven quality assessment and performance improvement program will remain.

Hospice

• Annual Training. (New since 4/21 Release) CMS is modifying the requirement at 42 CFR §418.100(g)(3), which requires hospices to annually assess the skills and competence of all 19 04/29/2020 individuals furnishing care and provide in-service training and education programs where required. Pursuant to section 1135(b)(5) of the Act, we are postponing the deadline for completing this requirement throughout the COVID-19 PHE until the end of the first full quarter after the declaration of the PHE concludes. This does not alter the minimum personnel requirements at 42 CFR §418.114. Selected hospice staff must complete training and have their competency evaluated in accordance with unwaived provisions of 42 CFR Part 418.

Physical Environment for Multiple Providers/Suppliers

• Inspection, Testing & Maintenance (ITM) under the Physical Environment Conditions of Participation: CMS is waiving certain physical environment requirements for Hospitals, CAHs, inpatient hospice, ICF/IIDs, and SNFs/NFs to reduce disruption of patient care and potential exposure/transmission of COVID-19. The physical environment regulations require that facilities and equipment be maintained to ensure an acceptable level of safety and quality.
• CMS will permit facilities to adjust scheduled inspection, testing and maintenance (ITM) frequencies and activities for facility and medical equipment.
• Specific Physical Environment Waiver Information: o 42 CFR §482.41(d) for hospitals, §485.623(b) for CAH, §418.110(c)(2)(iv) for inpatient hospice, §483.470(j) for ICF/IID; and §483.90 for SNFs/NFs all require these facilities and their equipment to be maintained to ensure an acceptable level of safety and quality. CMS is temporarily modifying these requirements to the extent necessary to permit these facilities to adjust scheduled inspection, testing and maintenance (ITM) frequencies and activities for facility and medical equipment. o 42 CFR §482.41(b)(1)(i) and (c) for hospitals, §485.623(c)(1)(i) and (d) for CAHs, §482.41(d)(1)(i) and (e) for inpatient hospices, §483.470(j)(1)(i) and (5)(v) for ICF/IIDs, and §483.90(a)(1)(i) and (b) for SNFs/NFs require these facilities to be in compliance with the Life Safety Code (LSC) and Health Care Facilities Code (HCFC). CMS is temporarily modifying these provisions to the extent necessary to permit these facilities to adjust scheduled ITM frequencies and activities required by the LSC and HCFC. The following LSC and HCFC ITM are considered critical are not included in this waiver:
• Sprinkler system monthly electric motor-driven and weekly diesel engine-driven fire pump testing.
• Portable fire extinguisher monthly inspection.
• Elevators with firefighters’ emergency operations monthly testing.
• Emergency generator 30 continuous minute monthly testing and associated transfer switch monthly testing.
• Means of egress daily inspection in areas that have undergone construction, repair, alterations or additions to ensure its ability to be used instantly in case of emergency. o 42 CFR §482.41(b)(9) for hospitals, §485.623(c)(7) for CAHs, §418.110(d)(6) for inpatient hospices, §483.470(e)(1)(i) for ICF/IIDs, and §483.90(a)(7) for SNFs/NFs require these facilities to have an outside window or outside door in every sleeping room. CMS will permit a waiver of these outside window and outside door requirements to permit these providers to utilize facility and non-facility space that is not normally used for patient care to be utilized for temporary patient care or quarantine.

Ambulatory Surgical Centers

• Medical Staff. 42 CFR 416.45(b). CMS is waiving the requirement at § 416.45(b) that medical staff privileges must be periodically reappraised, and the scope of procedures performed in the ASC must be periodically reviewed. This will allow for physicians whose privileges will expire to continue practicing at the ambulatory surgical center, without the need for reappraisal, and for ASCs to continue operations without performing these administrative tasks during the PHE. This waiver will improve the ability of ASCs to maintain their current workforce during the PHE.

Community Mental Health Centers

• Quality assessment and performance improvement (QAPI). 42 CFR 485.917(a)-(d) We are modifying the requirements for CMHC’s quality assessment and performance improvement (QAPI). Specifically, we are retaining the overall requirement that CMHC’s maintain an effective, ongoing, CMHC-wide, data-driven QAPI program, while providing flexibility for CMHCs to use their QAPI resources to focus on challenges and opportunities for improvement related to the PHE by waiving the specific detailed requirements for the QAPI program’s organization and content at § 485.917(a)-(d). Waiving the requirements related to the details of the QAPI program’s organization and content will make it easier for CMHCs to reconfigure their QAPI programs, as needed, to adapt to specific needs and circumstances that arise during the PHE. These flexibilities may be implemented so long as they are consistent with a state’s emergency preparedness or pandemic plan.
• Provision of Services. 42 CFR 485.918(b)(1)(iii). We are waiving the specific requirement at § 485.918(b)(1)(iii) that prohibits CMHCs from providing partial hospitalization services and other CMHC services in an individual’s home so that clients can safely shelter in place during the PHE while continuing to receive needed care and services from the CMHC. This waiver is a companion to recent regulatory changes (INSERT IFR CITATION WHEN RELEASED) that clarify how CMHCs should bill for services provided in an individual’s home, and how such services should be documented in the medical record. While this waiver will now allow CMHCs to furnish services in client homes, including through the use of using telecommunication technology, CMHCs continue to be, among other things, required to comply with the nonwaived provisions of 42 CFR Part 485, Subpart J, requiring that CMHCs: 1) assess client needs, including physician certification of the need for partial hospitalization services, if needed; 2) implement and update each client’s individualized active treatment plan that sets forth the 25 04/29/2020 type, amount, duration, and frequency of the services; and 3) promote client rights, including a client’s right to file a complaint.
• 40 Percent Rule. 42 CFR 485.918(b)(1)(v) We are waiving the requirement at § 485.918(b)(1)(v) that a CMHC provides at least 40 percent of its items and services to individuals who are not eligible for Medicare benefits. Waiving the 40 percent requirement will facilitate appropriate timely discharge from inpatient psychiatric units and prevent admissions to these facilities because CMHCs will be able to provide PHP services to Medicare beneficiaries without restrictions on the proportion of Medicare beneficiaries that they are permitted to treat at a time. This will allow communities greater access to health services, including mental health services.

Centers for Medicare & Medicaid Services

• CMS has published new information for clinicians about multiple flexibilities for its Quality Payment Program in response to the COVID-19 crisis, including extending the 2019 MIPS data submission deadline, information on reporting data from clinical trials, and more.
• CMS has published a memo to state Medicaid programs to clarify the different types of testing available for laboratories, whether the tests are being offered under an emergency use authorization issued by the FDA or as described in the FDA’s COVID-19 Test Guidance for these tests systems, and the CLIA certificates under which testing can be performed.
• CMS has posted a guide to flexibilities for home health agencies in their response to COVID-19.
• CMS has awarded $20 million in grants to combat COVID-19 through greater use of telehealth.
• CMS will host a call on nursing homes on Wednesday, May 6 at 4:30 p.m. (eastern) to provide updates on its latest COVID-19 guidance and leaders in the field will share best practices.  The call-in number is 833-614-0820 and the access passcode is 8899983.  Individuals who cannot get through to the call can follow it on an audio webcast.
• CMS will host an “office hours” call on Tuesday, May 5 at 5:00 p.m. (eastern) during which providers can ask CMS staff questions about the agency’s temporary actions in response to the COVID-19 emergency.  The call-in number is 833-614-0820 and the access code is 3996146.  Individuals who cannot get through to the call can follow it on an audio webcast.
• CMS will host a call on home health and hospice care on Tuesday, May 5 at 3:00 (eastern) to provide updates on its latest COVID-19 guidance and to hear leaders in the field share their best practices.  The call-in number is 833-614-0820 and the access passcode is 7844154.  Individuals who cannot get through to the call can follow it on an audio webcast.

Centers for Disease Control and Prevention

• The CDC has posted new resources on contact tracing, including:
  • a document with information about the role of contact tracing as part of a multi-pronged approach to fighting COVID-19;
  • a guide to contact tracing training;
  • COVID-19 contact tracing training guidance and resources;
  • principles of contact tracing; and
  • preliminary criteria for the evaluation of digital contact tracing tools for COVID-19.

Food and Drug Administration

• The FDA has issued guidance on exemption and exclusion from certain requirements of the Drug Supply Chain Security Act during the COVID-19 emergency.
• The FDA has posted an FAQ on ventilators.

National Institutes of Health

• The NIH has issued a news release announcing the launch of its Rapid Acceleration of Diagnostics (RADx) initiative aimed at speeding innovation, development, and commercialization of COVID-19 testing technologies.

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, April 29 as of 3:30 p.m.

Pennsylvania Update

Department of Human Services

DHS is accelerating estimated April-June 2020 Appendix 14 and 17 payments to the HealthChoices physical health managed care plans.  That money should be distributed to hospitals on June 4.

Department of Health Daily Briefing

• The state today reported a large increase in the COVID-19 death count, the result of researching and then reconciling data regarding questionable cases dating back a week or more. The increase does not suggest a sudden surge in deaths.
• 7698 residents of 461 long-term-care facilities have contracted COVID-19, as have 2634 health care workers.
• 2781 people with COVID-19 are currently hospitalized and 602 of them are on ventilators.
• 47 percent of the state’s hospital beds and 40 percent of its ICU beds are currently unoccupied and nearly 70 percent of its ventilators are idle.
• Social distancing and masks will still be needed in areas of the state that reopen.
• The state will provide information later this week about which types of businesses will be permitted to reopen and how it intends to undertake contact tracing.
• The state has distributed a large quantity of N95 masks in the last 24 hours.
• The state is still taking a regional approach to deciding which areas can begin to reopen but may deviate from that approach if appropriate.
• Regular flu cases are not included in COVID-19 case counts. The state counts 130,000 cases of flu this season resulting in 102 deaths while it has had (so far) more than 43,000 cases of COVID-19 leading to 2195 deaths.
• In addition to the quantitative measure to be used to help determine whether regions or counties are permitted to open, the state also will consider testing capacity, contact tracing plans, and health system capacity if there were to be another outbreak.
• State officials are still discussing how much information, if any, to reveal about death and case counts in individual long-term-care facilities.

Governor Wolf

Governor Wolf, as expected, vetoed S.B. 857, which would have authorized health care professionals to use telemedicine and require its coverage and payment by health insurers.  In his veto message, Governor Wolf noted that the bill, as amended in the House, interferes with women’s health care and the decision-making between patients and their physicians.  As a reminder, the amendment would have prohibited numerous drugs determined by the U.S. Food and Drug Administration to be “risky,” including a drug used to induce abortions, from eligibility for telemedicine consultative services.

General Assembly

Pennsylvania Senate Democrats unveiled their plan for using $3.9 billion in federal CARES Act money the state has received.  To date, Governor Wolf and Senate and House Republican leaders have agreed to keep the money in the state Treasury while awaiting what they hope will be additional guidance from the federal government – and the possibility that they will be permitted to use the money to replace state revenue lost amid the COVID-19 crisis.

The Senate Democrats’ proposal would allocate $650 million of the $3.9 billion for certain health care providers, first responders, and frontline workers and $1.1 billion for individuals/families.  See a complete list of how they would allocate the funding here.

Federal Update

Centers for Medicare & Medicaid Services

• CMS has posted a letter to clinicians participating in its Merit-based Incentive Payment System (MIPS) explaining how participating in a clinical trial and reporting their findings to a clinical data repository or registry may earn them credit in the 2020 performance period.
• CMS has updated its FAQ on Medicare fee-for-service billing. The update features a new question on the MIPS program.
• CMS has issued a transmittal on the quarterly update of the long-term-care hospital (LTCH) prospective payments system fiscal year 2020 pricer to reflect changes in the 50 percent rule, site-neutral payments, and the 25-day length-of-stay requirement during the COVID-19 emergency. The change request updates the LTCH pricer software used in original Medicare claims processing.  The update also is described in an article in CMS’s online publication MLN Matters.
• CMS is holding a COVID-19 stakeholders call for nurses on Thursday, April 30 at 3:30 p.m. (eastern). The toll-free dial-in number is 833-614-0820 and the access code is 4268398.  An audio webcast can be reached here.  Individuals who cannot participate during the call can find information about transcripts and podcasts here.
• CMS is hosting a call for ambulatory surgery centers and freestanding emergency departments to provide updates on the agency’s latest COVID-19 guidance on Thursday, April 30 at 12 noon (eastern). Agency officials will be available to answer technical and operational questions from providers.  The toll-free dial-in number is 833-614-0820 and the access code is 4366486.  An audio webcast can be reached here.  Individuals who cannot participate during the call can find information about transcripts and podcasts here.
• CMS is holding a COVID-19 stakeholders call on “lessons from the front lines,” featuring CMS Administrator Seema Verma, FDA Commissioner Stephen Hahn, MD, and the White House Coronavirus Task Force on Friday, May 1 at 12:30 p.m. (eastern). The toll-free dial-in number is 877-251-0301 and the access code is 9545128.  An audio webcast can be reached here.  Individuals who cannot participate during the call can find information about transcripts and podcasts here.

Centers for Disease Control and Prevention

• The CDC has published its serology surveillance strategy.
• The CDC has collected its various guidance documents for different types of health care facilities.
• The CDC has updated its guidelines for collecting, handling, and testing clinical specimens for persons with COVID-19.
• The CDC has published guidance for cleaning and disinfecting public spaces, workplaces, businesses, schools, and home.
• The CDC has updated its frequently asked questions and answers about COVID-19 and children (scroll down about one-third of the way down the web page).
• The CDC has posted interim guidance on breastfeeding and breast milk feeds in the context of COVID-19.

Food and Drug Administration

• The FDA has posted advice on bioequivalence studies for submission in abbreviated new drug applications (ANDAs) during the COVID-19 pandemic. This advice also addresses clinical trials for such drugs that have been affected by COVID-19.
• The FDA has issued an emergency use authorization (EUA) for a new serology test.
• The FDA has issued an EUA for the accelerated use of a COVID-19 test by a single children’s hospital.

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, April 28 as of 4:00 p.m.

Pennsylvania Update

Department of Human Services

DHS has sent a memo to the HealthChoices physical health managed care organizations advising them on the use of the CR modifier and the DR condition code for COVID-19-related claims.

Department of Health Daily Briefing

• After three days of declines in the number of new COVID-19 cases, the total increased yesterday.
• More than 2500 of the state’s 43,000 positive tests for COVID-19 are for health care workers and more than 7300 are residents of 452 long-term-care facilities.
• 2777 patients are currently hospitalized with COVID-19 and 611 of them are on ventilators.
• 47 percent of the state’s hospital beds and 40 percent of its ICU beds are currently unoccupied and 70 percent of its ventilators are not in use.
• Governor Wolf has indicated that the state will be looking at both counties and regions when deciding which parts of the state to reopen.
• The current plan is to announce the first openings on May 1, with those openings to take effect on May 8.
• The state has not developed benchmarks for testing capacity when counties or regions reopen but will provide further information about this on Friday.
• Secretary Levine agrees with Philadelphia’s health commissioner that the COVID-19 peak has probably passed in Philadelphia but cautioned against future outbreaks and spoke of the need to be prepared for them if they occur.

Federal Update

White House

The Trump administration has released two new documents to support its plan for reopening the country and its economy:  a testing overview and an accompanying testing blueprint.

Centers for Disease Control and Prevention

The CDC has updated its COVID-19 guidance for different types of clinical facilities.

Food and Drug Administration

• After questions arose about its April 18 emergency use authorization (EUA) about the uses of non-surgical face masks, the FDA has re-issued that EUA to manufacturers of face masks, health care personnel, hospital purchasing departments, distributors, and other stakeholders to clarify that face masks, including cloth face coverings, that are authorized by the EUA are only authorized for use by the general public and health care personnel as “source control.”  See the FDA’s FAQ about its clarification on the use of non-surgical face masks and its letter to stakeholders on the authorized uses of non-surgical masks.
• The FDA’s Small Business and Industry Assistance office will hold a webinar on conducting clinical trials during the COVID-19 emergency on Thursday, April 30.
• The FDA has issued an EUA for the use of a specific commercial monitoring system to be used for the remote monitoring of changes in cardiac activity among patients hospitalized with COVID-19 who are being treated with drugs such as hydroxychlorine and chloroquine that may cause life-threatening arrhythmias.
• The FDA has issued EUAs for the use of four new specific commercial tests for detecting COVID-19.  Find those EUAs 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.)