Healthcare

HHS Office for Civil Rights Bulletin on Civil Rights Issues During the COVID-19 Crisis

Numerous media reports concern the shortage of medical resources, personal protective equipment, and qualified professionals during the growing COVID-19 medical emergency.  As a result, providers may ultimately have to make choices regarding resource allocation among hospitalized patients suffering from COVID-19.  Disability rights and other advocacy groups have expressed concern about resource allocation from the point of view of how individuals with pre-existing disabilities and other individuals may have been treated in the past by the medical system.  While bioethicists may work to address the ethical issues involved with treating patients under conditions of resource scarcity, providers rightfully may worry about potential legal liability in distributing scarce resources among those in need.  While both the Trump Administration and Congress have acted to allay some of these worries, concerns remain for both individual practitioners and the facilities with which they work.

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CAUTION FOR PHYSICIANS DURING COVID-19

As COVID-19 cases surge, medical regulators are taking swift action to ensure that drugs required to treat the virus are prescribed based on evidence, and that they remain available to patients who need them. A directive was issued this week from the Ontario Pharmacists Association, Ontario Medical Association, and Registered Nurses’ Association of Ontario, which can be found here. The Directive reminds medical professionals of their obligation to educate patients that treatments for COVID-19, like with any illness, need to be evidence based. Read the full article.

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Some States Are Prioritizing Telehealth Through Section 1135 Waiver Requests

On March 13, 2020, President Trump issued a proclamation that the novel coronavirus (“COVID-19”) outbreak in the United States constituted a national emergency. Following this proclamation, pursuant to section 1135(b) of the Social Security Act, the Secretary of the Department of Health and Human Services (“HHS”), Alex Azar, invoked his authority to waive or modify certain requirements of titles of the Act as a result of the consequences of the COVID-19 pandemic, to the extent necessary, as determined by the Centers for Medicare & Medicaid Services (“CMS”), to ensure that sufficient health care items and services are available to meet the needs of individuals enrolled in the Medicare, Medicaid, and Children’s Health Insurance Programs (“CHIP”). This authority took effect on March 15, 2020, with a retroactive effective date of March 1, 2020 and will terminate at the conclusion of the public health emergency period.[1] Pursuant to this authority, HHS announced a number of nationwide blanket waivers, including a waiver related to telehealth, in order for providers to respond to the COVID-19 public health emergency.[2]

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HHS Issues Blanket Waivers for Certain Financial Relationships Subject to the Stark Law

WHO: The Secretary of the Department of Health and Human Services (HHS)

WHAT: Issued nationwide “blanket waivers” of the federal Stark Law (Section 1877 of the Social Security Act) pursuant to his authority Section 1135 of the Social Security Act.

WHEN: Although issued on March 30, 2020, the waivers are retroactively effective as of March 1, 2020.

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FDA Issues Update to Guidance for Clinical Trials During the COVID-10 Pandemic

On Friday, March 27, 2020, FDA issued an update to previous guidance titled, “FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic” (the “Guidance”), adding an Appendix with ten questions and answers for specific topics based on feedback received on the initial March 18th Guidance. To supplement our prior blog post, we identify some key takeaways from the updated Guidance below:

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Value-Based Payment Arrangements During the COVID-19 Pandemic

The ongoing pandemic caused by the novel coronavirus has upended the American health care system in many ways. One of the many effects of COVID-19 will likely be substantial disruption in value-based payment arrangements between health plans and providers. Though this is an issue that is not on the top of providers or payors minds as the health care system prepares to respond to the crisis, there are some simple steps that providers can take now to avoid issues in the future.

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LEGAL AND REGULATORY FRAMEWORK FOR DIGITAL HEALTH – TELEMEDICINE PRACTICE GUIDELINES

In a significant move, the Ministry of Health and Family Welfare (“MoHFW”) on March 25, 2020 has issued the Telemedicine Practice Guidelines (“Guidelines”) for enabling Registered Medical Practitioners (“RMPs”) to provide healthcare using telemedicine. As per the Guidelines, ‘telemedicine’ is the delivery of health care services, where distance is a critical factor, by all the healthcare professionals using information and communication technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, all in the interests of advancing the health of individuals and their communities.

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HOW TO ASSIST WITH THE MEDICAL SUPPLY SHORTAGE

As the COVID-19 pandemic continues to develop across Canada, medical professionals anticipate that there could be a shortage in medical supplies and equipment. While all levels of government have been taking steps to respond to COVID-19 and to obtain necessary supplies, they have also reached out to the private sector to assist. Read the full article.

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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

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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

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