Healthcare

SAMHSA issues guidance on disclosure of substance use disorder patient information

On March 19, 2020, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued guidance on disclosure of substance use disorder (SUD) information during the COVID-19 pandemic national emergency period. READ MORE

Read full article

SAMHSA encourages telehealth for substance use disorder patients

Late last week the Substance Abuse and Mental Health Services Administration (SAMHSA) issued guidance encouraging the use of telehealth for substance use disorder (SUD) patients during the COVID-19 pandemic national emergency period. READ MORE

Read full article

DEA allows remote prescribing of controlled substances

On March 20, 2020, the Drug Enforcement Administration (DEA) posted guidance allowing DEA-registered practitioners to prescribe controlled substances remotely (e.g., through telehealth) during the COVID-19 national emergency period. READ MORE

Read full article

CMS issues guidance on payments for state medicaid telehealth services provided during COVID-19 pandemic

In recent guidance, the Centers for Medicare and Medicaid Services (CMS) intended to help states better understand policy options for paying Medicaid providers using telehealth to deliver patient services in combating COVID-19. CMS has recently been encouraging providers to use telehealth services due to the benefit of increasing access to care while reducing the risks for spread of infection and exposure for vulnerable populations. READ MORE

Read full article

Secretary Azar Urges Governors to Take Action to Lift Restrictions to Extend the Capacity of the Health Care Workforce

In response to the growing concerns of the capacity of the health care workforce as a result of the COVID-19 pandemic, on March 24, 2020 the Secretary of Health and Human Services, Alex Azar, issued a letter and associated Guidance to all Governors urging them to take immediate action.  While the federal government, and some states, have admirably waived and relaxed many rules related to the provision of various types of benefits and services, including relaxed telehealth and privacy rules/enforcement, many necessary actions are within the authority of state governments. Presumably, this plea from Secretary Azar is an attempt to “close the gap” between what the federal government has done to remove these barriers and the stringent restrictions of many state licensure laws. Specifically, Azar sets forth eight action items that he is asking Governors and the District of Columbia to consider in order to lift the limits that state rules currently place on licensure, scope of practice, certification, and recertification/relicensure. The action items include:

Read full article

Personal Jurisdiction in a Time of Social Distancing

Across the nation, authorities are scrambling to meet the new challenges posed by COVID-19. The United States Centers for Disease Control and Prevention (“CDC”) has recommended that individuals remain six feet apart in order to prevent the spread of COVID-19. On March 13, 2020, the White House proclaimed a national emergency and many State governments have ordered non-essential businesses to close, and residents to self-distance. However, these emergency measures conflict with the rules for personal service of process established by Federal Rule of Civil Procedure 4.

Read full article

FDA Eases Device Modification Rules to Expand Availability of Ventilators During COVID-19 Pandemic

On March 22, 2020, the U.S. Food and Drug Administration (“FDA”) issued guidance, for immediate implementation, that aims to increase the availability of ventilators and other respiratory devices needed to address the COVID-19 pandemic.  While FDA urges health care facilities to use, wherever possible, FDA-cleared standard full-featured ventilators to treat COVID-19 patients (as well as other patients requiring ventilatory support), FDA will allow a more flexible approach to modifications to these devices to help boost manufacturing capacity and supply.  FDA also took the opportunity to lay out guidelines that encourage submission of Emergency Use Authorization (“EUA”) applications for devices not marketed in the United States, continuing an unprecedented Agency response to the pandemic.

Read full article

FDA Confirms That At-Home Collection Kits Are Not Authorized for Use with COVID-19 Tests

On March 16, 2020, FDA finalized its guidance titled Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (the “Policy”). The Policy includes information and recommendations to assist laboratories and commercial manufacturers in development of diagnostic tests for the novel coronavirus (“COVID-19”) during the ongoing pandemic.

During the first week of implementation, questions arose regarding the extent to which the Emergency Use Authorization (“EUA”) pathway to market, as described by the Policy, covers at-home tests. The Policy specifically provides that it “does not apply to at home testing” (emphasis added). However, the industry still questioned the FDA’s stance on the use of at-home collection kits, allowing a consumer to self-collect a specimen and mail in a swab or similar collection device to a laboratory running an FDA-approved COVID-19 test.

Read full article

First Federal COVID-19-Related Enforcement Action Filed as DOJ and FBI Commit to Preventing Fraud in the Nation’s Response to the COVID-19 Pandemic

After U.S. Attorney General, William P. Barr[1] and the Federal Bureau of Investigation issued warnings this week regarding potential fraudulent schemes that are being perpetrated in the nation’s response to the COVID-19 pandemic, on Sunday, March 22, 2020, the U.S. Department of Justice (DOJ) filed its first enforcement action to shut down COVID-19-related fraud.  DOJ attorneys moved in federal court in Austin, Texas for a temporary restraining order against operators of a website, coronavirustestingkit.com, alleged to have engaged in a wire fraud scheme by offering consumers access to “free” World Health Organization (WHO) vaccine kits in exchange for a shipping charge, which required consumers to enter credit card information on the website.[2] The website stated that the kits “only” required water to administer the vaccine and provided testimonials from “recent users.” The government alleged that claims made on the website are false, as the WHO is not offering free vaccine kits and there is not yet a scientifically proven vaccine, and that the intent of the website is to gain access to consumer credit card information.

Read full article

COVID-19 impact on telehealth services

The Centers for Medicare & Medicaid Services, the Office of Inspector General of the Department of Health and Human Services and the Office for Civil Rights have each issued separate announcements that enhance the ability to furnish telehealth during the COVID-19 public health emergency. These policies will allow flexibility during the coronavirus emergency period to provide telehealth services:

  • Without collecting coinsurance and deductible amounts from federal health care program patients. Click here to read more
  • Using applications such as FaceTime, Skype, Messenger video, or Google Hangouts even if the applications don’t meet HIPAA standards. Click here to read more
  • Using smart phone for telehealth communication and providing services via telehealth even when the patient is at a location (such as his or her home) that does not satisfy Medicare telehealth originating site standards.
    Click here to read more

CMS has also issued guidance intended to help states better understand policy options for paying Medicaid providers using telehealth to deliver patient services in combating COVID-19. Click here to read more

Read full article