April 24, 2020 

To expand the availability of devices for remote reviewing and reporting of scanned digital images of pathology slides, the FDA issued guidance, Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.  The intent of this policy is to increase availability of these devices to facilitate continuity of patient care by preventing disruptions to critical pathology services while reducing healthcare personnel risk of exposure to COVID-19. The FDA advised it does not intend to object to (1) modifications to the FDA-cleared indications, functionality, hardware and/or software, of the digital pathology devices identified in the policy to provide for use in a remote setting, or (2) the marketing of new digital pathology devices of the types specified in the policy that are intended for use in remote settings and that are not currently 510(k) cleared for any use, without compliance with submission of a premarket notification under section 510(k) of the FD&C Act and 21 CFR 807.81,6 Good Manufacturing Practice requirements in 21 CFR Part 820, and Unique Device Identification (UDI) requirements in 21 CFR Part 830 and 21 CFR 801.20.

Additionally, for remote digital pathology devices subject to this policy, FDA does not intend to enforce compliance with the special controls identified in 21 CFR 864.1860 which includes requirements for the content of a premarket notification submission for a whole slide imaging system. This policy will remain in effect through the duration of the public health emergency and may be found here. 

April 23, 2020 

States have broad flexibility to cover telehealth services through Medicaid, including which methods of communication providers are allowed to use to provide telehealth services. CMS issued a toolkit for the use of states to assist with the adoption of broader telehealth coverage. The toolkit will help states identify their current policies which may impede the rapid provision of telehealth and may be found here.

April 23, 2020

Guidance was issued by CMS to allow licensed, independent freestanding emergency departments, which the law currently law does not recognize as a certified Medicare provider, in four states (Colorado, Delaware, Rhode Island, and Texas) to temporarily be certified as a hospital and provide care to Medicare and Medicaid patients to handle any COVID-19 surge.  The guidance may be found here. 

April 19, 2020

Under the leadership of President Trump, CMS will require nursing homes to inform residents, their families and representatives of COVID-19 cases in their facilities. CDC will be providing a reporting tool to nursing homes that will support CMS’ efforts in COVID-19 transparency efforts, surveillance and response. This is a joint effort between CMS and the CDC.  The data that is collected will be made available to the public. 

The requirements for notification may be found here. 

CMS also issued recommendations for healthcare facilities and providers to gradually re-open in areas throughout the country that are seeing a decline in cases, such as communities in Phase 1 of the Guidelines for Opening Up American Again.   The recommendations update earlier guidance issued by CMS. 
The Guidelines for Opening Up America Again can be found here. 

The new recommendations can be found here. 

April 17, 2020

The Florida Agency for Health Care Administration (AHCA) issued a reminder to long-term care and residential facilities that although it is critical to notify residents, families, authorized representatives and staff of confirmation of positive cases, facilities must protect residents’ privacy rights by limiting disclosure to the fact that a positive case was confirmed. Facilities must not disclose the identity of the person who tested positive, and must have a process in place to meet the Agency’s expectations. 

April 17, 2020 

The Florida Agency for Health Care Administration (AHCA) published additional requirements and instructions to hospitals on information that must be included in reports on hospital census and available bed data. 

The publication may be found online. 

April 15, 2020 

The Centers for Medicare & Medicaid Services (CMS) announced Medicare will nearly double payment for certain lab tests that use high-throughput technologies to rapidly diagnose large numbers of 2019 Novel Coronavirus (COVID-19) cases.  Effective April 14, 2020, through the duration of the COVID-19 national emergency, Medicare will pay the higher payment of $100 for COVID-19 clinical diagnostic lab tests making use of high-throughput technologies developed by the private sector that allow for increased testing capacity, faster results, and more effective means of combating the spread of the virus.  Medicare also will pay new specimen collection fees for COVID-19 testing for homebound and non-hospital inpatients to help facilitate the testing of homebound individuals and those unable to travel. For other COVID-19 laboratory tests, local Medicare Administrative Contractors (MACs) remain responsible for developing the payment amount in their respective jurisdictions.  

More information on this payment announcement may be found here.

CMS additionally published guidance for Inpatient Prospective Payment System (IPPS) hospitals and long-term care hospital (LTCH) inpatient hospitals on how to code claims to receive the increased payment the Coronavirus Aid, Relief, and Economic Security (CARES) Act. 

The guidance may be found online.

April 14, 2020

Revisions were made by the Centers for Disease Control and Prevention to the Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for COVID-19 to clarify specimen collection procedures for all swab types and align with other respiratory disease specimen collection guidelines. 

The Guidelines may be found here. 

April 14, 2020

To date, the FDA has issued 34 emergency use authorizations for diagnostic tests that detect the COVID-19 virus.  The FDA also updated its FAQs on diagnostics, including that it supports at-home testing, but has not yet authorized such testing, with or without the use of telemedicine. 

Currently, no products are approved by the U.S. Food and Drug Administration (FDA) to prevent or treat COVID-19.  The FDA announced it issued warning letters to three sellers of fraudulent COVID-19 products, including herbal and other products misbranded for the prevention and treatment of COVID-19.

April 13, 2020

By memorandum dated April 13, 2020, Centers for Medicare & Medicaid Services (CMS) announced its postponement of the 2019 benefit year HHS Risk Adjustment Data Validation process to allow health insurance issuers and providers to focus on threats due to the COVID-19 virus.

The memorandum may be found here. 

CMS additionally released further guidance through Frequently Asked Questions (FAQs) including on enhanced Medicaid funding and the new optional Medicaid eligibility group for uninsured individuals, and benefits and cost sharing for testing and diagnostic services during the COVID-19 public health emergency under the Families First Coronavirus Response Act and the Coronavirus Aid, Relief, and Economic Security (CARES) Act. 

The Frequently Asked Questions may be found here. 

April 13, 2020

The U.S. Food and Drug Administration (FDA) announced the steps taken to ensure an adequate supply of chloroquine phosphate and hydroxychloroquine sulfate. Among other things, the FDA published product-specific guidances (PSGs) to support generic drug development for the drugs, and prioritized review of newly submitted Abbreviated New Drug Applications (ANDAs) for chloroquine phosphate and hydroxychloroquine sulfate under MAPP 5240.3: Prioritization of the Review of Original ANDAs, Amendments, and Supplements.  

The PSGs may be found here. 

April 11, 2020

Guidance was issued today by the Centers for Medicare & Medicaid Services (CMS) and the Departments of Labor and the Treasury implementing the Families First Coronavirus Response Act (FFCRA) and Coronavirus Aid, Relief, and Economic Security (CARES) Act.  The new guidance implements the requirement for group health plans and group and individual health insurance to cover both diagnostic testing and certain related items and services provided during a medical visit with no cost sharing, including urgent care visits, emergency room visits, and in-person or telehealth visits to the doctor’s office that result in an order for or administration of a COVID-19 test. Covered COVID-19 tests include all FDA-authorized COVID-19 diagnostic tests, COVID-19 diagnostic tests that developers request authorization for on an emergency basis, COVID-19 diagnostic tests developed in and authorized by states, and COVID-19 antibody testing.

The guidance may be found here. 

April 10, 2020 

Florida Department of Health (DOH) adopted Emergency Rule No. 64DER20-26 (64D-3.029), effective upon its filing with the Department of State, on April 10, 2020, updating the “Table of Reportable Diseases or Conditions to be Reported” to specifically include COVID-19 in the list of diseases of public health significance which must be reported by practitioners, hospitals, and laboratories to the DOH.  The Emergency Rule mandates that results should be reported immediately and accompanied by any testing conducted, both positive and negative results.  

The Emergency Rule may be found here. 

April 10, 2020 

The U.S. Food and Drug Administration issued an emergency use authorization for a blood purification system to treat patients 18 years of age or older with confirmed Coronavirus Disease 2019 (COVID-19) admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.

The emergency use authorization may be found here. 

April 10, 2020

Today the HHS Office for Human Research Protections (OHRP) issued guidance on COVID-19 for investigators, institutional review boards, and institutions conducting human subjects research during the coronavirus (COVID-19) pandemic, highlighting that the Common Rule should allow necessary actions to be taken to protect public health, but continue to protect the research participants. 

The guidance may be found here. 

April 9, 2020

The Office for Civil Rights (OCR) announced that during the nationwide public health emergency and retroactive to March 13, 2020, it will not impose penalties for HIPAA Rules violations against covered entities or business associates for their good faith participation in the operation of COVID-19 testing sites. This exercise of OCR’s enforcement discretion supports those providers participating in operating Community Based-Testing Site (CBTS), such as mobile, drive-through, or walk-up sites that only provide COVID-19 specimen collection or testing services to the public.

The notice may be found here. 

April 9, 2020

Yesterday, the Office of the Assistant Secretary for Health issued new guidance under the Public Readiness and Emergency Preparedness Act (“PREP Act”) designed to expand COVID-19 testing capabilities by relaxing pharmacy regulations. Under the new guidance, licensed pharmacists, who often are the most accessible and the first healthcare professionals contacted by many individuals, may order and administer COVID-19 tests, including serology tests, authorized by the FDA. These pharmacists qualify as “covered persons” under the PREP Act, and thus will have the benefit of the Act’s immunity protection for all claims--except for death or serious physical injury caused by willful misconduct--for any loss, including death and physical or mental injury resulting from the administration or use of these tests as a covered countermeasure.  The guidance does not change government or private payer reimbursement rules. 

The full guidance document can be found here.