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.)

COVID-19 update for Monday, April 27 as of 3:30 p.m.

Pennsylvania Update

Department of Health

The Department of Health has issued guidance on the terms under which hospitals can begin performing elective procedures again and under which ambulatory surgical facilities may begin performing elective procedures again.

Department of Health Daily Briefing

• The number of newly reported cases has declined for the third consecutive day.
• 2394 positive tests have been among health care workers and 7037 have been among residents of 441 long-term-care facilities.
• 2799 people are currently hospitalized for COVID-19 and 615 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 not in use.
• Secretary Levine discussed the criteria for the state to reopen regions.  She cautioned against too great a focus on the number of cases per 100,000 population and explained that to reopen, regions also would need a certain level of testing capacity, enough personal protective equipment, have enough hospital staff to handle any surge in cases, and not be operating under crisis standards of care.
• The state is doing well in finding more testing materials for the state lab and Secretary Levine said more needs to be done to make this supply chain more reliable and to do the same for others that perform tests as well.

Governor Wolf

The Wolf administration has issued a news release elaborating on the data-driven and qualitative measures that will be used to determine when individual regions of the state will be permitted to reopen.

Federal Update

Department of Health and Human Services

• Last Friday HHS deposited its second tranche of CARES Act funding in hospitals’ bank accounts.  We have contacted HHS to inquire about the specifics of the funding formula, whether there are additional future attestation requirements, the timing for the next round of payments, and more.

In the meantime, providers that received Provider Relief Payments in either round of funding should visit the CARES Act General Distribution Portal, where you will be able to provide data that HHS may use to calculate payment distributions from the Provider Relief Fund.  (Other useful resources:  the CARES Act Provider Relief Fund web page and an FAQ on the General Distribution Portal.  Also, please note: the General Distribution Portal is not the same as the Attestation Portal.)

Specifically, the portal is collecting the following four pieces of information:

1. a provider’s “Gross Receipts or Sales” or “Program Service Revenue” as submitted on its federal income tax return;
2. the provider’s estimated revenue losses in March 2020 and April 2020 due to COVID;
3. a copy of the provider’s most recently filed federal income tax return; and
4. a listing of the tax identification numbers any of the provider’s subsidiary organizations that have received relief funds but that DO NOT file separate tax returns.

In addition, providers can submit separate applications for CARES Act funding for any additional entities that received Provider Relief Fund payments and that also filed a separate tax return for 2017, 2018, or 2019.  See the provider relief fund page and FAQ for further details.

• HHS has updated its CARES Act Provider Relief Fund web page. Included is a new update on the distribution of remaining funds designated for providers in the CARES Act and what providers need to do to receive their share of these funds.  It also reminds providers that they must agree to the terms and conditions of this funding through the CARES Act Provider Relief Fund Payment Attestation Portal.
• HHS’s Health Resources and Services Administration (HRSA) this afternoon opened a web portal through which providers can submit claims for payment for COVID-19-related services they have provided to uninsured patients.  As described in an HHS news release,

Health care providers who have conducted COVID-19 testing or provided treatment for uninsured COVID-19 individuals on or after February 4, 2020 can request claims reimbursement through the program electronically and will be reimbursed generally at Medicare rates, subject to available funding. Steps will involve: enrolling as a provider participant, checking patient eligibility, submitting patient information, submitting claims, and receiving payment via direct deposit.

To participate, providers must attest to the following at registration:

• You have checked for health care coverage eligibility and confirmed that the patient is uninsured. You have verified that the patient does not have coverage such as individual, employer-sponsored, Medicare or Medicaid coverage, and no other payer will reimburse you for COVID-19 testing and/or care for that patient
• You will accept defined program reimbursement as payment in full.
• You agree not to balance bill the patient.
• You agree to program terms and conditions and may be subject to post-reimbursement audit review.

The new web page also includes information about covered services, claims submission, and claims reimbursement.

Centers for Medicare & Medicaid Services

• CMS has announced that it is re-evaluating the amounts it will have available for Part A providers with new and pending applications under its Accelerated Payment Program and is suspending its Advance Payment Program for Medicare Part B suppliers effective immediately.  Now that Congress has appropriated $175 billion for the grant-style “Provider Relief Fund,” CMS is shifting away from the cash advance approach of the Advance and Accelerated Payment Programs.  Part B suppliers will no longer be able to apply for the Advance Payment Program and CMS will be re-evaluating the amounts available for Part A providers with new and pending applications under the Accelerated Payment Program.  Previously, Part A and Part B providers were able to request an advance on Medicare fee-for-service payments up to a maximum value of six months’ worth of payments.  See CMS’s news release explaining its shift in approach and an updated fact sheet on the Accelerated and Advance Payment Programs.
• CMS has updated its FAQ on Medicare fee-for-service billing.  In particular, the updated FAQ provided more specific information about use of the condition code “DR” and the modifier “CR” for claims for which Medicare payment is conditioned on the premise of a formal waiver.
• CMS has informed state governments that it will hold constant the inspection domain of the Nursing Home Compare site due to the prioritization and suspension of certain surveys during the COVID-19 emergency to ensure that the rating system provides fair information for consumers.

Centers for Disease Control and Prevention

• The CDC has updated its information for clinicians on therapeutic options for COVID-19 patients.

Food and Drug Administration

• The FDA has issued a news release reiterating the importance of close patient supervision for off-label use of anti-malaria drugs to mitigate the known risks of those drugs.
• The FDA will host a virtual town hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for COVID-19 on Wednesday, April 29 at 12:15 (eastern).
• The FDA has issued emergency use authorizations (EUAs) for two COVID-19 serology tests (here and here) and for a reagent to be used in such serology tests.

Occupational Safety and Health Administration

• OSHA has issued interim enforcement guidance on reusing disposable N95 filtering face piece respirators that have been decontaminated.

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, April 23 as of 4:00 p.m.

Attention:  Health Care Providers

HHS has extended until 3:00 p.m. (eastern) on Saturday, April 25 the deadline for providers to submit data that will be used to determine how it will allocate the $10 billion it will be distributing to providers hit especially hard by COVID-19.  Providers that have been targeted for possible assistance from this pool have already been notified of the need to submit data, although such notice does not assure funding.

State Update

Department of Health Daily Briefing

• After a week of declines in the number of new COVID-19 cases, the daily case count has returned to its higher levels of one to two weeks ago.
• More than 6000 residents of 418 long-term-care facilities located in 40 of the state’s counties have tested positive for COVID-19, as have more than 700 people who work at those facilities.
• More than 2000 of the Pennsylvanians who have tested positive for COVID-19 are health care workers.
• 2746 people are currently hospitalized with COVID-19 and 662 of them are on ventilators.
• 47 percent of the state’s acute-care beds and 40 percent of its ICU beds are currently unoccupied and nearly 70 percent of its ventilators are not in use at this time.

Department of Health

The Department of Health has issued a notice to hospitals reminding them that they are required to promptly notify any first responder agency that is known to have transported a patient determined to be positive for COVID-19 and that they must do so as soon possible and no later than 48 hours after the determination.  This requirement is the same as that called for in the Ryan White HIV/AIDS Treatment Extension Act of 2009.

Insurance Department

The state Insurance Department has published COVID-19 guidance regarding volunteer physicians, podiatrists, and certified nurse midwives practicing under a reactivated license.  The notice addresses the medical malpractice insurance obligations of such volunteers depending on where they practice during the COVID-19 pandemic.

Pennsylvania Health Law Center

The Pennsylvania Health Law Center has launched a “COVID-19 Resource Center.”  While it has useful information, its primary target audiences appears to be consumers and those who work with consumers.

Federal Update

Centers for Medicare & Medicaid Services

• CMS has launched a COVID-19 partner toolkit that includes links to almost all activity involving the federal response to the COVID-19 crisis.
• CMS has launched a new toolkit to help states navigate COVID-19 health workforce issues.
• CMS has issued two new section 1135 waivers to states this week. Go here to see them and other 1135 waivers the agency has issued since the beginning of the COVID-19 pandemic.

Centers for Disease Control and Prevention

• The CDC has posted a human infection with COVID-19 person under investigation and case report form.
• The CDC has posted a guide on the use of personal protective equipment when caring for COVID-19 patients.
• The CDC has posted updated guidance for different types of health care facilities dealing with COVID-19.
• The CDC has published clinical care guidance about COVID-19 for health care professionals.
• The CDC has posted information about assessing risk factors for severe COVID-19 illness.
• The CDC has posted guidance on water-borne transmission of COVID-19.
• The CDC has published interim guidance for public health and health care professionals managing people with COVID-19 in home care and isolation who have pets or other animals.
• The CDC has shared conventional, contingency, and crisis strategies for the use of elastomeric respirators.

Food and Drug Administration

• The FDA has published guidance on its enforcement policy for imaging systems during the COVID-19 emergency.
• The FDA has unveiled its enforcement policy for remote digital pathology devices during the COVID-19 emergency.
• The FDA has issued an emergency use authorization (EUA) for a specific commercial device for use to treat lung failure when used as an adjunct to non-invasive or invasive mechanical ventilation.
• The FDA has issued an EUA for a specific commercial blood purification system, including for use in continuous renal replacement therapy.

National Institutes of Health

• The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has shared its plan for accelerating research to diagnose, prevent, and treat COVID-19.

The White House

• Alabama, Alaska, and Delaware have been added to the list of states that the federal government has authorized to use the National Guard to assist with their COVID-19 response, with 100 percent of the cost of this assistance paid by the federal government.

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 23 as of 5:00 p.m.

Pennsylvania Update

Governor Wolf

On Wednesday night Governor Wolf addressed the state about his plan to gradually reopen Pennsylvania and its economy.  While the governor had previously announced some reopenings, he outlined general parameters for authorizing additional steps and further business activity.

Reopening the state, he said, would be based on a three-phase approach and guidelines for attempting to maintain control of COVID-19:  to make sure that case counts are under control and that the population of the regions identified for possible reopening have fewer than 50 cases per 100,000 residents over 14 days before people can return to work.  Target dates for some reopenings may change, he said, if conditions and case counts change, but the goal is to begin on May 8.

Governor Wolf emphasized that continued social distancing and use of masks is imperative and that reopening would not be state-wide but would be on a regional basis, depending on their conditions.  He will be making the decisions about regional reopenings, he said, and not local or county officials, and those decisions will be data-driven.  Based on current conditions, he said, reopening is most likely to start in northern central Pennsylvania and the northwestern part of the state, but that has not yet been decided.

The governor also said the Department of Health has been talking to hospital industry representatives about resuming non-urgent elective procedures.

Learn more about Governor Wolf’s plan here.

Department of Human Services

• DHS has written to the federal Centers for Medicare & Medicaid Services to request Medicaid state plan amendments in response to the COVID-19 emergency.  The amendments include suspension of co-payments for screening, diagnosis, and treatment for COVID-19; benefit flexibility to authorize the use of additional cough and cold suppressant products; suspension of prior authorization requirements for certain services and for the permitted supply of covered outpatient drugs; and more.
• DHS has also written to CMS to request approval of its disaster relief state plan amendment to seek flexibilities in how the state operates its Children’s Health Insurance Program (CHIP).  These flexibilities include:
• allowing enrollees to receive services beyond their certification period by extending CHIP renewal deadlines;
• temporarily delaying acting on certain changes in circumstances;
• accepting self-attestation and conduct post-enrollment verification;
• allowing individuals to provide a reasonable explanation of inconsistencies in lieu of requiring paper documentation;
• extending deadlines for submitting verification at renewal;
• temporarily suspending application of co-payments related to COVID-19 testing, screening, and treatment services; and
• temporarily delaying payment of premiums (and/or delay payment of premium balance).
• DHS has published an announcement listing the functions managed by its Office of Developmental Programs that it is suspending state-wide until further notice.  Previously, these functions had been suspended for a limited period of time.

Department of Health Daily Briefing

• Secretary Levine explained the difference between confirmed cases of COVID-19 and probable cases and between confirmed deaths from COVID-19 and probable deaths from COVID-19.  She said that in both situations, “probable” means the cases are under investigation.
• “Probable” classifications account for only about two percent of cases.
• Investigation of probable deaths has led the state to reduce its COVID-19 death count by 201 from yesterday.
• Secretary Levine responded to numerous questions about Governor Wolf’s plan for reopening Pennsylvania.
• When making decisions about regional reopenings the state will be using confirmed data, not probable data.
• She stressed that reopening parts of Pennsylvania will be on a regional basis and not a county-by-county basis.  The state has not yet completely defined the regions it will use for this purpose.
• When determining whether regions meet the cases per 100,000 population criterion for reopening, cases in long-term-care facilities will be counted because employees enter and exit those facilities.
• The Department of Health is currently formulating its plan for future contact tracing.
• When deciding whether to reopen regions, factors such as the availability of testing, an adequate supply of hospital beds, contact tracing capabilities, and other considerations will figure in the governor’s decisions.
• Those regions will need to have enough testing capacity to accommodate a loosening of the current, strict criteria for who can be tested for COVID-19.
• Amid concern about how many COVID-19 patients end up needing dialysis, the Department of Health will be exploring the adequacy of the current supply of dialysis machines.

Department of Health

With long-term-care facilities now accounting for approximately 50 percent of COVID-19 deaths in Pennsylvania. The Department of Health’s web site now tracks cases and deaths associated with nursing homes and personal care homes.  Go here and scroll about two-thirds of the way down the page.

Department of Community and Economic Development

The Department of Community and Economic Development has established a business-to-business exchange through which health care organizations seeking N95 masks, fabric and other masks, surgical and procedure masks, and thermometers can identify and do business with Pennsylvania companies that sell such supplies.

Pennsylvania Emergency Management Agency

The Wolf administration has launched an online portal for individuals, corporations, and community organizations to inform others about critical medical supplies available for donation during the COVID-19 pandemic.

Federal Update

Congress

The House has passed H.R. 266, the $384 billion COVID-19 relief/economic stimulus bill  that includes $75 billion for health care providers and $25 billion for testing.

Department of Health and Human Services

• Providers that received an email from CMS on Sunday night informing them that they are in a COVID-19 hotspot were directed to register their information through https://www.teletracking.com/ by noon on Saturday, April 25.  Doing so does not guarantee eligibility for a share of the $10 billion that CMS announced yesterday that it would be distributing among providers that have been hit hard by COVID-19 but failing to provide the requested information will exclude providers from eligibility.  Only providers that received the Sunday night email from CMS can submit the information to the site.
• The Department of Health and Human Services has updated its CARES Act Provider Relief Fund web page to include new information about how it intends to distribute the final $70 billion of the $100 billion designated for hospitals in the CARES Act.  It also describes its distribution methodology and timetable for distribution in this news release.
• HHS’s Office of the Inspector General has updated its FAQ addressing the application of its administrative enforcement authority to arrangements directly connected to the COVID-19 emergency.

Centers for Medicare & Medicaid Services

• CMS has issued an FAQ on utilization management flexibilities health insurers can offer to mitigate the impact of COVID-19 on health care providers.
• CMS has updated its guidance to Medicare Advantage organizations, Part D sponsors, and Medicare-Medicaid plans to further expand on a number of flexibilities they may implement during COVID-19 public health emergency to support efforts that can help curb the spread of the virus and to help ensure Medicare Advantage and Part D enrollees do not experience disruptions in care or disruptions in pharmacy and prescription drug access.
• CMS has updated its guidance for infection control and prevention of COVID-19 for home health agencies and religious non-medical health care institutions that make home health visits, including those that enter non-Medicare-licensed facilities.
• CMS has established a new toolkit for states to help accelerate adoption of broader telehealth coverage policies in the Medicaid and Children’s Health Insurance Programs (CHIP) during the COVID-19 pandemic.
• CMS has extended the comment period for stakeholder response to its proposed rule titled “Medicare Program:  Comprehensive Care for Joint Replacement Model Three-Year Extension and Changes to Episode Definition and Pricing,” which was published on February 24.  The comment deadline, originally April 24, is now June 23.

Centers for Disease Control and Prevention

• The CDC has published information about how health care providers can optimize their supply of personal protective equipment.
• The CDC has posted strategies or options to optimize supplies of disposable N95 masks in health care settings when there is a limited supply.
• The CDC has updated its guidance on the decontamination of filtering facepiece respirators using contingency and crisis capacity strategies.
• The CDC has published information about contact tracing and COVID-19.
• The CDC has posted a tool for individuals to assess and manage their risk based on different exposures to COVID-19.
• The CDC has updated its FAQ on children and COVID-19.
• The CDC has published information for health care providers about pregnant women and COVID-19.

Food and Drug Administration

• The FDA has announced an enforcement policy for the use of non-invasive fetal and maternal monitoring devices to support patient monitoring during the COVID-19 crisis to expand the availability and capabilities of those devices.
• The FDA has issued an emergency use authorizations (EUAs) for monitors intended for use in hospitals to monitor adult, pediatric, and neonate patients having or suspected of having COVID-19.
• The FDA has issued EUAs for two new tests (here and here) to detect COVID-19.
• The FDA has issued guidance on its temporary policy regarding accredited third-party certification program on-site observation and certification requirements during the COVID-19 emergency.

National Governors Association

• The National Governors Association has published “Roadmap to Recovery:  A Public Health Guide for Governors.”  The 38-page document presents the organization’s plan for reopening states in a manner that preserves public safety and confidence.

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.)

The following is the latest information from state and federal regulators and others as of 4:30 p.m. on Monday, April 20.

Pennsylvania Update

Governor Wolf

Governor Wolf today announced that he was extending his stay-at-home order through May 8, at which time the state may, depending on the status of spread of COVID-19, begin permitting some industries and businesses to resume operations while still observing social distancing guidelines.  Pennsylvania’s liquor stores have begun curbside pick-up and online auto sales will be permitted to resume, with notaries doing their work online.  Construction projects would be permitted to resume on May 8.  The administration is exploring permitting some retailers to engage in curbside pick-ups but the governor acknowledged that this presented different challenges in different places.  He said the reopening of the state’s economy would be regional rather than state-wide, that some things that may be realistic in Cameron County may not be feasible in Philadelphia, and that all reopening efforts would be contingent on the progress of the COVID-19 pandemic between now and May 8.  He did not speak about anything involving health care other than to note that social distancing appears to have been effective in preventing the health care system from becoming overwhelmed at the height of the crisis.

In addition, today Governor Wolf signed S.B. 841 into law, providing flexibilities for businesses.  The bill reauthorizes the Health Care Cost Containment Council (PHC4) and requires that it study the impact of COVID-19 on hospitals and health systems.  It also:

• permits local governments to conduct remote public meetings;
• provides property tax relief by permitting taxing districts to waive late fees and penalties for property taxes paid by December 31, 2020;
• permits school districts to renegotiate contracts with service providers to ensure payment of personnel and fixed costs during the school closure; and
• permits remote notarization of documents.

Governor Wolf vetoed S.B. 613, which would have immediately reopened the state and ended the governor’s stay-in-place orders.

Daily COVID-19 Briefing

• With a one-day exception, the number of new cases reported daily has continued to decline in recent days and fell into three figures yesterday for the first time this month.
• Despite this, the death count continues to rise, although this rise can be attributed in part to a more careful analysis of death reports and decisions to link some deaths to COVID-19 that were not previously categorized that way. The overall state death toll from COVID-19 now exceeds 1200, all of them adults.
• Data on COVID-19 cases in Pennsylvania is now available on the department’s web site at the county level and at the zip code level.
• 3057 Pennsylvanians are currently hospitalized with COVID-19 and 645 of them are now on ventilators.
• 42 percent of acute-care hospital beds and 36 percent of ICU beds are currently unoccupied and nearly 70 percent of ventilators are currently available for use.
• Secretary Levine reported that the state’s hospitals are doing well and are not overwhelmed with COVID-19 patients although she noted that hospitals in the southeastern part of the state have higher-than-usual daily censuses but are still doing well.

Department of Health

• The department has issued an FAQ about the Secretary’s order directing public health safety measures for businesses permitted to maintain in-person operations.
• The department has issued interim guidelines for the implementation of practices to safeguard the health of employees who work in life-sustaining businesses.

• The department posted an FAQ on staffing resources for nursing care facilities during the COVID-19 crisis in response to requests for guidance on what staffing measures can be implemented or contemplated during the crisis. In addition, guidance is now available for facilities that wish to expand their number of beds or convert closed wings or entire facilities to support COVID-19 patients or residents. Because this latter guidance is available only through a subscription-only department message board and cannot be reached through a direct link, it is presented in its entirety below:

If a facility wishes to expand the number of beds or convert closed wings or entire facilities to support COVID-19 patients or residents, first review PA-HAN 496, Universal Message Regarding Cohorting of Residents in Skilled Nursing Facilities. If the facility’s planned strategy appears to conform with PA-HAN 496, submit a request to the Department of Health’s (Department) field office (list below). Each request will be considered on a case-by-case basis, and dialogue with the facility will occur to acquire all details needed to render a decision. To ensure the Department has the necessary information to enter into that dialogue, include at a minimum the following (if applicable) with the request:

Number of beds and/or residents impacted, including whether residents will be moved initially

Whether the beds are Medicare or Medicaid (including proof of approval from the Department of Human Services to expand the number of MA beds, if applicable)

Location and square footage (with floor plan and pictures, if appropriate)

Available equipment

Staffing levels and plan for having adequate staffing for the duration

Plan for locating residents (including care of vulnerable residents (such as dementia residents)

Description of how residents with COVID-19 will be handled (e.g., moving within the facility, admitted from other facilities, admitted from the hospital)

Plan for discontinuing use of any new, altered or renovated space upon the expiration of the Governor’s Proclamation of Disaster Emergency issued on March 6, 2020

Upon submission of the request, a representative from the Department will reach out to the facility’s contact person to discuss next steps. Questions regarding this process can be directed to the appropriate field office.

Field Office Contacts:

Michele Gresko MGRESKO@pa.gov – Scranton Field Office
Traci Duncan tduncan@pa.gov – Williamsport Field Office
Rose Martin ROMARTIN@pa.gov – Lehigh Valley Field Office
Ellen Fuller elfuller@pa.gov – Lionville Field Office
Jennifer Lyons jelyons@pa.gov – Jackson Field Office
Mary Anne Bennis mbennis@pa.gov – Norristown Field Office
Heidi McKay hmckay@pa.gov – Norristown Field Office
Kiera Price kieprice@pa.gov – Harrisburg Field Office
Renee Bergamaschi rbergamasc@pa.gov – Johnstown Field Office
Denise Scolieri dscolieri@pa.gov – Pittsburgh Field Office
Lil Agostinella – LAGOSTINEL@pa.gov – Pittsburgh Field Office

Department of Human Services

• DHS has issued a document addressing Medicaid eligibility during the COVID-19 emergency reminding providers that as authorized by the governor, anyone who was eligible for Medicaid in Pennsylvania as of March 18 will remain eligible until the end of the current emergency. Providers that encounter problems with eligibility issues when using the state’s Medicaid eligibility verification system (EVS) should advise the individual they are attempting to serve to contact their local county assistance office.
• DHS has re-posted a memo it sent to HealthChoices physical health managed care plans in March conveying the same message.

Department of State

The Department of State has extended the expiration dates of temporary permits for more health care licenses during the COVID-19 emergency.  The boards and professions to which this temporary waiver applies are:

• State Board of Massage Therapy
• State Board of Physical Therapy – physical therapists, physical therapy assistants
• State Board of Medicine – graduate physician assistants, respiratory therapists, athletic trainers, orthotic fitters, pedorthists, graduate orthotist, provisional orthotist, prosthetist graduate permits, and genetic counselor provisional licenses
• State Board of Osteopathic Medicine – respiratory therapist temporary licenses, athletic trainer temporary licenses, genetic counselor temporary provisional licenses.

Federal Update

Centers for Medicare & Medicaid Services

• CMS has issued guidance on providing non-essential non-COVID-19 care to patients without symptoms of COVID-19 in regions with low and stable incidence of COVID-19. It views this guidance as part of phase one of the administration’s plan to reopen the U.S. economy.  See CMS’s news release on this guidance here and the guidance itself here.  Under this guidance, individual states will determine for themselves when it is appropriate to begin the “reopening” process.  As a practical matter, only Oklahoma, Texas, and Alaska, to our knowledge, have identified concrete dates for commencing the delivery of the described non-essential care.
• To ensure appropriate tracking, response, and mitigation of COVID-19 in nursing homes, CMS is reinforcing an existing requirement that nursing homes must report communicable diseases, health care-associated infections, and potential outbreaks to state and local health departments. In rulemaking that will follow, CMS is requiring facilities to report this data to the Centers for Disease Control and Prevention and Control (CDC) in a standardized format and frequency defined by CMS and CDC.  See CMS’s announcement of its intentions; a memo CMS has sent to state Medicaid agencies; and additional CDC guidance.
• In February, CMS published a rule that would change certain requirements for pre-admission screening and resident review (PASRR) to reflect updates in diagnostic criteria for mental illness and intellectual disability. Because of the COVID-19 emergency, the agency is extending the deadline for stakeholder comment from the current April 20 – today – to May 20.

Department of Health and Human Services

• HHS has published in the Federal Register a notice to inform the public that it is exercising its discretion in how it applies the privacy, security, and breach notification rules under HIPAA and that its Office of Civil Rights will not impose penalties for non-compliance with the regulatory requirements under the HIPAA rules against covered health care providers in connection with the good faith provision of telehealth during the COVID-19 nation-wide public health emergency.

Food and Drug Administration

• The FDA has issued a statement on the various approaches it is currently pursuing to accelerate the development of treatments for COVID-19.
• The FDA has issued a memorandum to manufacturers of face masks, health care personnel, hospital purchasing departments, distributors, and other stakeholders regarding face masks intended for use by the general public, as opposed to health care professionals. The memo addresses the purpose of such masks, how they must be labeled to prevent unauthorized and inappropriate uses, and how they must be labeled to prevent potentially harmful uses.
• The FDA has issued a temporary policy for the compounding of certain drugs for hospitalized patients by pharmacy compounders not registered as outsourcing facilities during the COVID-19 crisis.
• The FDA has issued an emergency use authorization (EUA) for a certain commercial product used to reduce pathogens and inflammatory mediators from the bloodstream of adult patients with COVID-19 and who have been admitted to a hospital intensive care unit with confirmed or imminent respiratory failure.
• The FDA has issued an EUA for a specific commercial qualitative test for the detection of nucleic acids from COVID-19 in nasopharyngeal, nasal, and mid-turbinate nasal swab specimens, bronchoalveolar lavage fluid, and sputum from individuals who are suspected of COVID-19.

Federal Emergency Management Agency

• FEMA has published a notice of exemptions to an April 10 regulation addressing the prioritization and allocation of certain scarce or threatened health and medical resources for domestic use. In the notice, FEMA details specific circumstances under which the ban against the export of certain scarce or threatened materials will not be enforced.

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.)

The following is the latest COVID-19 information from the state and federal governments as of 4:30 p.m. on Friday, April 17.

Pennsylvania Update

Daily COVID-19 Briefing

During today’s COVID-19 briefing, Governor Wolf addressed the subject of “reopening” Pennsylvania following the limits he has placed on the state’s residents and its businesses, community life, and social interactions in response to the COVID-19 crisis.  He emphasized the need to continue social distancing, said his administration has been working for weeks to develop plans for reopening the state, and explained that any such effort would be data-driven and local and regional, as opposed to state-wide.  He mentioned the importance of doing more to support the health care system and said that any reopening must ensure the state’s continued ability to respond to COVID-19 challenges if they re-emerge.  What he described today, he said, was a framework for future action, and he said he would provide more details next week.

In the meantime, his office released three documents in support of his plans:  one on relief, reopening, and recovery; one on businesses; and one on health care.

From the Department of Health’s daily update news release on the COVID-19 crisis:

• After several days of more modest numbers, new COVID-19 cases rose considerably yesterday and deaths remain high.
• More than half of all COVID-19 deaths in Pennsylvania to date have been among residents of 321 different long-term-care facilities.

Department of Health

The department has updated its March 24 interim infection prevention and control recommendations for patients in health care settings who have COVID-19 or are under investigation for COVID-19.  The new guidance explains that “As community transmission intensifies within a region, healthcare facilities may consider foregoing contact tracing for exposures in a healthcare setting in favor of universal source control for HCP and screening for fever and symptoms before every shift, as well as the end of every work shift…”

The Department of Health sent a letter to hospitals reminding them that the CARES Act requires each provider of a diagnostic test for COVID-19 to publicize the cash price of the test on a public internet website of the provider.

Department of Human Services

DHS has updated its March 20 guidance to reflect that it will not be conducting any annual licensing inspections for entities licensed by its Office of Developmental Programs, Office of Child Development and Early Learning, Office of Long-Term Living/Bureau of Human Services Licensing, and Office of Children, Youth and Families until Governor Wolf lifts his current disaster emergency proclamation or until such other time determined by DHS.

DHS has issued a memorandum to HealthChoices physical health managed care organizations about telemedicine guidelines related to COVID-19.  This memo clarifies issues related to HIPAA compliance in the use of communication technology and the use of out-of-state practitioners and supersedes a similar memo DHS sent to the HealthChoices plans last month.

Department of State

The Department of State has waived certain administrative requirements for graduate medical trainees during the COVID-19 emergency.  Until this waiver was implemented, medical residents with graduate medical trainee licenses who wished to work elsewhere, in addition to where they were serving as residents, needed to provide to the state a detailed written statement of the medical services they would be providing beyond the parameters of the graduate medical trainee program and receive a board evaluation of their training and education.  This required statement has now been temporarily waived.

Pennsylvania Congressional Delegation

Ten Democratic members of Pennsylvania’s congressional delegation have written to Health and Human Services Secretary Alex Azar and Centers for Medicare & Medicaid Services Administrator Seema Verma to complain that the manner in which they have allocated the first $30 billion of the $100 billion designated for hospital and health care providers in the federal CARES Act “…disadvantages Pennsylvania and many of our key providers in several ways.”  Go here for a link to the letter.

Federal Update

The White House

• President Trump has unveiled “Guidelines for Opening Up America Again,” a three-phase approach to reopening the economy.  Find that plan here.
• President Trump has signed a memorandum authorizing the use of the National Guard by governors in five more states to help with their response to the COVID-19 emergency, with the cost of National Guard assistance to be assumed 100 percent by the federal government.  The five states are Iowa, Kansas, Maine, Nebraska, Oklahoma, and Vermont.

Centers for Medicare & Medicaid Services

• In the latest edition of its online publication MLN Matters, CMS outlines new and expanded flexibilities for rural health clinics and federally qualified health centers during the COVID-19 emergency.

Food and Drug Administration

• The FDA has issued an emergency use authorization (EUA) for the use of a new commercial test to diagnose prior infection by the virus that causes COVID-19.
• The FDA issued guidance to help expand the availability of telethermographic systems used for body temperature measurements for triage use for the duration of the COVID-19 emergency.
• The FDA added content to the question-and-answer appendix in its guidance document “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.”

Centers for Disease Control and Prevention

• The CDC has updated its COVID-19 guidance to pharmacists and pharmacies.

National Institutes of Health

• The NIH has announced the launch of a public-private partnership to speed the development of COVID-19 vaccine and treatment options.

National Health Services Corps

• The National Health Service Corps and Nurse Corps has updated its FAQ for National Health Service Corps and Nurse Corps participants and approved sites.

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

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