Coronavirus response leads to cuts to 166 or more FDA, EPA, Medicare, alcohol and education regulations

The Trump administration and state and local governments are wisely suspending regulations to help fight the coronavirus.
Many of these rules and regulations were not necessary in the first place, given their tendency to reduce innovation and access to care, not to mention their restriction on American liberty.
Below is a list of suspended rules and regulations, starting with federal waivers, followed by state and local waivers. If you have another example to add, please send it to [email protected].

Imagine de Gerd Altmann de la Pixabay

Suspended federal rules and regulations:
“The FDA will allow states to take responsibility for tests developed and used by laboratories within their borders. The labs will not have to pursue Emergency Use Authorization from the agency, an emergency clearance that is normally required.” – STAT News (3/16/20)
“Under certain circumstances, the agency will not object to any manufacturers that distribute newly developed tests before the FDA grants emergency clearance, and a similar stance will be taken toward labs that use these new tests.” – STAT News (3/16/20)
“The CDC has granted a right of reference to the performance data contained in CDC’s EUA request (FDA submission number EUA200001) to any entity seeking an FDA EUA for a COVID-19 diagnostic device.”
So far, they have has issued dozens (and counting) emergency authorizations for COVID-19 tests. This includes Abbott Laboratories’ portable coronavirus test and Bodysphere Inc.’s serological testing kit, that can detect a positive or negative result for COVID-19 in two minutes. Follow the link here to find the list. – U.S. Food and Drug Administration (2/29/20 – Present)
“This deregulatory action will allow greater flexibility for truck drivers transporting goods such as necessary medical supplies, testing equipment, hand sanitizer, disinfectants and food required for emergency restocking of stores.” – Americans for Tax Reform (3/16/20)
“The administration removed a regulation that required all test kits to be sent to a CDC lab to be confirmed by federal authorities, a process that extended the wait times for patients to be notified about their results.” – Washington Examiner (3/13/20)
The “requirements that physicians or other health care professionals hold licenses in the State in which they provide services, if they have an equivalent license from another State (and are not affirmatively barred from practice in that State or any State a part of which is included in the emergency area)” are being waived. – U.S. Department of Health and Human Services (3/13/20)
“TSA is allowing passengers to bring liquid hand sanitizer containers up to 12 ounces in carry-on bags until further notice. Passengers can expect that these containers larger than the standard allowance of 3.4 ounces of liquids permitted through a checkpoint will need to be screened separately…” – Transportation Security Administration (3/13/20)
In order to allow patients to more easily communicate with their providers, the Administration loosened the HIPAA requirements surrounding telemedicine. This important change allows doctors to see patients via commonly used apps like FaceTime and Skype that were previously non-HIPAA compliant. – U.S. Department of Health and Human Services (3/17/20)
“HHS Secretary Alex Azar waive certain laws to expand the use of telehealth, which public health experts say can help reduce risk of transmission. The new order appears to let Azar waive federal licensing requirements so out-of-state doctors can treat patients virtually in states with the greatest need.” – Politico (3/13/20)
The Department of Education has moved to ease rules on colleges and universities who are shifting their classes online. There are a collection of rules being eased, not enforced. – Office of Postsecondary Education (3/5/20)
“Due to the Coronavirus 2019 (COVID-19) pandemic, the Acting Administrator of the Alcohol and Tobacco Tax and Trade Bureau (TTB) has found that it is necessary or desirable to waive provisions of internal revenue law with regard to distilled spirits, and therefore is providing certain exemptions and authorizations to distilled spirits permittees who wish to produce ethanol-based hand sanitizers to address the demand for such products during this emergency.” – Alcohol and Tobacco Tax and Trade Bureau (3/18/20)
“Faster, Easier Qualification Process for States Seeking SBA Disaster Assistance. Historically, the SBA has required that any state or territory impacted by disaster provide documentation certifying that at least five small businesses have suffered substantial economic injury as a result of a disaster, with at least one business located in each declared county/parish. Under the just-released, revised criteria, states or territories are only required to certify that at least five small businesses within the state/territory have suffered substantial economic injury, regardless of where those businesses are located.” – Small Business Administration (3/17/20)
The Trump Administration has extended the tax deadline to allow more flexibility in filing during this chaotic time. Americans for Tax Reform still recommends that taxpayers file their returns as soon as possible. Most taxpayers get refunds, in total amounting to about $50B in refunds that could be injected into the economy now. Taxpayers should be encouraged to file their returns as soon as possible to get refunds NOW to help them recover.
“Income tax payment deadlines for individual returns, with a due date of April 15, 2020, are being automatically extended until July 15, 2020, for up to $1 million of their 2019 tax due.”  – Internal Revenue Service (3/18/20)
“First, the guidance describes the agency’s intention to exercise enforcement discretion for certain modifications to these FDA-cleared devices. Normally, any time a manufacturer or user makes a modification to a ventilator device, for instance, adding wireless and/or Bluetooth capability for remote monitoring, those modifications can often trigger an FDA premarket review, which can delay the time it takes to get these devices to the bedside. The guidance also helps manufacturers ramp up their manufacturing by adding production lines or alternative sites, for instance, using non-medical device manufacturers such as automobile manufacturers, to start manufacturing ventilator parts….Second, as outlined in this guidance, hospitals and health care professionals may use ventilators intended for other environments… Finally, the agency encourages manufacturers, whether foreign or domestic, to talk to FDA about pursuing an emergency use authorization (EUA), which would allow them to distribute their ventilators in the United States.” – U.S. Food and Drug Administration (3/22/20)
“Federal Emergency Management Agency (FEMA) gave Puerto Rico and other territories the discretion to acquire personal protective equipment from non-U.S. sources… Previously, U.S. territories and the District of Columbia were obliged to purchase only U.S.-made personal protective equipment in accordance with the Buy American Act.” – Reason (3/24/20)
“The 60-day grant of special temporary authority (STA) for use of the lower 45 MHz of the band is to help them serve rural communities during the COVID-19 pandemic. The FCC said the grants will help with telehealth, distance learning and telework in rural communities in Arizona, California, Colorado, Florida, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, Nebraska, New Hampshire, New Mexico, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Virginia, Vermont, Washington, Wisconsin, and West Virginia.” – Multichannel News (3/27/20)
“CMS will allow communities to take advantage of local ambulatory surgery centers that have canceled elective surgeries, per federal recommendations. Surgery centers can contract with local healthcare systems to provide hospital services, or they can enroll and bill as hospitals during the emergency declaration as long as they are not inconsistent with their State’s Emergency Preparedness or Pandemic Plan. The new flexibilities will also leverage these types of sites to decant services typically provided by hospitals such as cancer procedures, trauma surgeries and other essential surgeries.” – Centers for Medicare & Medicaid Services (3/30/20)
“CMS will now temporarily permit non-hospital buildings and spaces to be used for patient care and quarantine sites, provided that the location is approved by the State and ensures the safety and comfort of patients and staff. This will expand the capacity of communities to develop a system of care that safely treats patients without COVID-19, and isolate and treat patients with COVID-19.” – Centers for Medicare & Medicaid Services (3/30/20)
“CMS will allow hospitals, laboratories, and other entities to perform tests for COVID-19 on people at home and in other community-based settings outside of the hospital. This will both increase access to testing and reduce risks of exposure. The new guidance allows healthcare systems, hospitals, and communities to set up testing sites exclusively for the purpose of identifying COVID-19-positive patients in a safe environment. In addition, CMS will allow hospital emergency departments to test and screen patients for COVID-19 at drive-through and off-campus test sites.” – Centers for Medicare & Medicaid Services (3/30/20)
“During the public health emergency, ambulances can transport patients to a wider range of locations when other transportation is not medically appropriate. These destinations include community mental health centers, federally qualified health centers (FQHCs), physician’s offices, urgent care facilities, ambulatory surgery centers, and any locations furnishing dialysis services when an ESRD facility is not available.” – Centers for Medicare & Medicaid Services (3/30/20)
“Physician-owned hospitals can temporarily increase the number of their licensed beds, operating rooms, and procedure rooms. For example, a physician-owned hospital may temporarily convert observation beds to inpatient beds to accommodate patient surge during the public health emergency.” – Centers for Medicare & Medicaid Services (3/30/20)
“In addition, hospitals can bill for services provided outside their four walls. Emergency departments of hospitals can use telehealth services to quickly assess patients to determine the most appropriate site of care, freeing emergency space for those that need it most. New rules ensure that patients can be screened at alternate treatment and testing sites which are not subject to the Emergency Medical Labor and Treatment Act (EMTALA) as long as the national emergency remains in force. This will allow hospitals, psychiatric hospitals, and critical access hospitals (CAHs) to screen patients at a location offsite from the hospital’s campus to prevent the spread of COVID-19.” – Centers for Medicare & Medicaid Services (3/30/20)
“Local private practice clinicians and their trained staff may be available for temporary employment since nonessential medical and surgical services are postponed during the public health emergency. CMS’s temporary requirements allow hospitals and healthcare systems to increase their workforce capacity by removing barriers for physicians, nurses, and other clinicians to be readily hired from the local community as well as those licensed from other states without violating Medicare rules.” – Centers for Medicare & Medicaid Services (3/30/20)
“CMS is issuing waivers so that hospitals can use other practitioners, such as physician assistants and nurse practitioners, to the fullest extent possible, in accordance with a state’s emergency preparedness or pandemic plan. These clinicians can perform services such as order tests and medications that may have previously required a physician’s order where this is permitted under state law.” – Centers for Medicare & Medicaid Services (3/30/20)
“CMS is waiving the requirements that a certified registered nurse anesthetist (CRNA) is under the supervision of a physician. This will allow CRNAs to function to the fullest extent allowed by the state, and free up physicians from the supervisory requirement and expand the capacity of both CRNAs and physicians.” – Centers for Medicare & Medicaid Services (3/30/20)
“CMS also is issuing a blanket waiver to allow hospitals to provide benefits and support to their medical staffs, such as multiple daily meals, laundry service for personal clothing, or child care services while the physicians and other staff are at the hospital and engaging in activities that benefit the hospital and its patients.” – Centers for Medicare & Medicaid Services (3/30/20)
“CMS is temporarily eliminating paperwork requirements and allowing clinicians to spend more time with patients. Medicare will now cover respiratory-related devices and equipment for any medical reason determined by clinicians so that patients can get the care they need; previously Medicare only covered them under certain circumstances.” – Centers for Medicare & Medicaid Services (3/30/20)
“During the public health emergency, hospitals will not be required to have written policies on processes and visitation of patients who are in COVID-19 isolation. Hospitals will also have more time to provide patients a copy of their medical record.” – Centers for Medicare & Medicaid Services (3/30/20)
“CMS is providing temporary relief from many audit and reporting requirements so that providers, healthcare facilities, Medicare Advantage health plans, Medicare Part D prescription drug plans, and states can focus on providing needed care to Medicare and Medicaid beneficiaries affected by COVID-19.” – Centers for Medicare & Medicaid Services (3/30/20)
“Building on prior action to expand reimbursement for telehealth services to Medicare beneficiaries, CMS will now allow for more than 80 additional services to be furnished via telehealth. During the public health emergencies, individuals can use interactive apps with audio and video capabilities to visit with their clinician for an even broader range of services. Providers also can evaluate beneficiaries who have audio phones only.” – Centers for Medicare & Medicaid Services (3/30/20)
“Providers can bill for telehealth visits at the same rate as in-person visits. Telehealth visits include emergency department visits, initial nursing facility and discharge visits, home visits, and therapy services, which must be provided by a clinician that is allowed to provide telehealth. New as well as established patients now may stay at home and have a telehealth visit with their provider.” – Centers for Medicare & Medicaid Services (3/30/20)
“CMS is making it clear that clinicians can provide remote patient monitoring services to patients with acute and chronic conditions, and can be provided for patients with only one disease. For example, remote patient monitoring can be used to monitor a patient’s oxygen saturation levels using pulse oximetry.” – Centers for Medicare & Medicaid Services (3/30/20)
“The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to BARDA to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile (SNS) to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible.” – Department of Health and Human Services (3/29/20)
“The EPA will exercise the enforcement discretion specified below for noncompliance covered by this temporary policy and resulting from the COVID-19 pandemic…
The consequences of the pandemic may affect facility operations and the availability of key staff and contractors and the ability of laboratories to timely analyze samples and provide results. As a result, there may be constraints on the ability of a facility or laboratory to carry out certain activities required by our federal environmental permits, regulations, and statutes. These consequences may affect reporting obligations and milestones set forth in settlements and consent decrees. Finally, these consequences may affect the ability of an operation to meet enforceable limitations on air emissions and water discharges, requirements for the management of hazardous waste, or requirements to ensure and provide safe drinking water… The enforcement discretion described in this temporary policy do not apply to any criminal violations or conditions of probation in criminal sentences. Appropriate consideration of potential criminal liability is discussed separately.” – U.S. Environmental Protection Agency (3/26/20)
Suspended state rules and regulations:
“Officials in Alabama have signed an emergency order to allow for the sale of alcoholic beverages curbside at licensed businesses in the state.” – WBRC (3/17/20)
“Due to the ongoing threat of coronavirus, the Alabama Board of Pharmacy is allowing pharmacists to process emergency refills on essential medications.” – WHNT (3/16/20)

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- Writer and Co-Founder of The Global Dispatch, Brandon has been covering news, offering commentary for years, beginning professionally in 2003 on Crazed Fanboy before expanding into other blogs and sites. Appearing on several radio shows, Brandon has hosted Dispatch Radio, written his first novel (The Rise of the Templar) and completed the three years Global University program in Ministerial Studies to be a pastor. To Contact Brandon email [email protected] ATTN: BRANDON

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