Coronavirus update for Friday, May 8 as of 2:30 p.m.

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.

CMS and Inpatient Rehabilitation Facilities

Today CMS sent to subscribers the latest edition of its publication MLN Matters (not yet available online) in which it announced flexibilities for inpatient rehabilitation facilities during the COVID-19 crisis.  The following is that notice, presented verbatim.

CMS is exercising regulatory flexibilities for Inpatient Rehabilitation Facilities (IRFs) during the COVID-19 Public Health Emergency (PHE) to waive the 60 percent rule.

We are also waiving IRF coverage and classification requirements if all of these criteria are satisfied:

• Patient is admitted to a freestanding IRF to alleviate acute care hospital bed capacity issues
• IRF is located in an area that is in Phase 1 or has not entered Phase 1; see Guidelines for Opening Up America Again

Add the following letters at the end of your unique hospital patient identification number (the number that identifies the patient’s medical record in the IRF) to identify patients eligible for each waiver:

• D- 60 percent rule
• DS- Coverage and classification requirements
• DDS- Both 60 percent rule and coverage and classification requirements

For More Information:

• COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers: See page 10 for 60 percent rule
• Interim Final Rule: Coverage and classification requirements

Also from the latest MLN Matters and also presented verbatim:

COVID-19: IRF Interdisciplinary Team Meetings During the Pandemic

CMS expects Inpatient Rehabilitation Facilities (IRFs) to hold in-person weekly interdisciplinary team meetings to discuss Medicare Part A fee-for-service patients. During the public health emergency, it may be safest to conduct meetings electronically. We will accept all appropriate forms of social distancing precautions.

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.

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.

Federal Funding Opportunities for Hospitals

• NASH has prepared a document that collects and presents in one place the various new federal funding opportunities for hospitals resulting from legislation addressing the COVID-19 public health emergency.  Find that document here.

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