FDA authorizes first at-home COVID-19 test

On April 21, 2020, the Food and Drug Administration announced its approval of the first at-home COVID-19 test pursuant to its Emergency Use Authorization authority.

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UPDATE: CMS reevaluates Accelerated Payment Program, suspends Advance Payment Program for Part B suppliers and points providers to relief fund

On April 26, 2020, the Centers for Medicare & Medicaid Services (CMS) announced that it is reevaluating pending and future amounts that it will pay under its Accelerated Payment Program and is suspending its Advance Payment Program for Part B suppliers, effective immediately. CMS noted it has already approved almost 24,000 applications resulting in $40.4 billion of payments for Part B suppliers, including doctors, non-physician practitioners and durable medical equipment suppliers.

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CMS increases Medicare payment for COVID-19 lab tests using high-production equipment

The Centers for Medicare and Medicaid Services (CMS) issued a new payment ruling and announced that effective April 14, 2020, and through the remainder of the emergency period, Medicare will pay $100 under Part B for each COVID-19 clinical diagnostic laboratory test (CDLT) processed using “high-throughput” equipment.

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FDA Authorizes the First Home Collection of Specimens to be Tested for COVID-19

As an update to our prior blog post, on April 20, 2020 FDA announced the authorization of the first COVID-19 test for home collection of specimens. This announcement, made via the Agency’s FAQs on Diagnostic Testing for SARS-CoV-2 webpage, comes after weeks of FDA reporting that it has been working closely with manufacturers on such a test during the weekly Virtual Town Hall Meetings hosted by the Center for Devices and Radiological Health. FDA clarifies that the test is only authorized for home collection of specimens to be sent back to a laboratory for processing. FDA still has not authorized a COVID-19 test “to be completely used and processed at home.”

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Governor Murphy Signs Various Bills into Law Seeking to Help Business Operations and Health Care Providers

Governor Murphy signed a number of bills into law on Tuesday, April 14, 2020 to help mitigate various negative impacts of the COVID-19 pandemic. The selection below illustrates new laws that specifically seek to facilitate the running of certain business operations as well as help licensed professionals, which may be of interest to a wide array of health care providers.

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$100 Billion Emergency Fund for Providers Under the CARES Act: New Guidance and Terms & Conditions of Acceptance

On April 10, 2020, the U.S. Department of Health and Human Services (“HHS”) provided additional details regarding its plan to provide billions in relief to providers in an effort to off-set healthcare-related expenses resulting from the Coronavirus (“COVID-19”) outbreak.

Passed into law on March 27, 2020, the Coronavirus Aid, Relief and Economic Security Act, also called the “CARES Act”, provided $100 billion in funding for the Public Health and Social Services Emergency Fund (the “Fund”). The Fund is a pre-existing resource overseen by the Office of Financial Planning & Analysis within HHS. The $100 billion added via the CARES Act was made available to qualifying healthcare providers to reimburse them for “health care related expenses or lost revenues that are attributable to [COVID-19]”. The CARES Act stipulated that the $100 billion would be made available to public entities, Medicare or Medicaid enrolled suppliers and providers and other entities as may be further specified in regulations or guidance, provided that any such provider must “provide diagnoses, testing or care for individuals with possible or actual cases of COVID-19”. Monies received from the Fund may not be used to cover expenses that have already been reimbursed through other sources or that other sources are obligated to reimburse. Little other detail regarding the funding or mechanism for disbursal was provided in the CARES Act itself.

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Covid-19 in Latvia: Updates regarding Covid-19

Amendments to the procedure for granting idle time benefits

Today, 9 April 2020, the Cabinet of Ministers amended the criteria for granting idle time benefits to employers affected by the crisis. The most essential amendments:

  • An employee receiving an idle time benefit shall be granted an additional allowance of EUR 50 for each dependent child under the age of 24 for whom the employee is entitled to a personal income tax credit on the date of granting the idle time benefit;
  • The members of the management board and supervisory board of the employer affected by the crisis may also receive the idle time benefit, if the income from economic activity of the employer affected by the crisis in 2019 does not exceed EUR 100,000;
  • Idle time benefit is also available to employees concurrently receiving old-age or retirement pension.
  • The procedure for calculating the idle time benefit for micro-enterprise taxpayers affected by the crisis has been adjusted.
  • From now on, only Cabinet Regulation No. 165 will apply to all employers affected by the crisis, regardless of the sector.

The text of the amendments to the Cabinet Regulation No. 165 is available here.

Changes in employment

  • It is determined that illness due to Covid-19 is not considered to be an accident at work;
  • Self-isolation during performance of job duties, if a person does not show signs of acute respiratory infection and the person is not recognized as a contact person of Covid-19 infectious disease, does not apply to:
  1. Latvian citizens, who return from Lithuania and Estonia after performing their job duties;
  2. Lithuanian and Estonian citizens, who enter the territory of Latvia to perform their job duties.

Medical devices and personal protective equipment

  • Procurement organized by public persons, subject to certain conditions, allows the purchase of personal protective equipment and medical devices, the conformity assessment procedure whereof has not been initiated or has not been fully completed, and which do not contain CE mark.

The text of the amendments to the Cabinet Order on declaring the state of emergency is available here.

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Compliance Tips for Medical Health APPs (Part II) – Personal Information Collection and Use

The Internet has been changing our lives at an unprecedented pace. In addition to E-shopping and food delivery, Internet medical services have become a significant part of our life. People start trying online diagnosis services when they feel sick; when they visit a doctor, they make online appointments beforehand; people also buy pharmaceuticals online as opposed to from brick and mortar pharmacies. Moreover, Internet medical services have permeated into our life, largely unnoticed. Our watches can measure our heart rate, electrocardiograph and even blood pressure, and more and more medical tests and assessments that were only available at hospitals can now be done remotely from home…… Read more…

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As media sources detail a supply shortage among COVID-19 first responders, physicians are questioning where the line is drawn between their right to refuse unsafe work and their duty to provide care. Read the full article.

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COVID-19: New Jersey Takes Action to Raise Health Care Personnel Levels

As the number of COVID-19 cases in the State of New Jersey continues to grow, Governor Murphy has issued various executive orders aimed at combatting COVID-19.  On April 1, 2020 the Governor signed Executive Order 112 (“EO 112”), which focuses on the health care industry with a goal of increasing the number of health care workers responding to COVID-19 in New Jersey.  EO 112, among others things:

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