Top News Stories for the Week of March 30

CMS Issues Temporary Regulatory Waivers and New Rules to Address COVID-19

CMS Press Release

The Centers for Medicare & Medicaid Services (CMS) on Monday issued an array of temporary regulatory waivers and new rules to equip the American health care system with maximum flexibility to respond to the COVID-19 pandemic. The temporary changes will allow hospitals and health systems to deliver services at other locations to make room for COVID-19 patients needing acute care in their main facility. The changes empower local hospitals and health care systems to rapidly expand treatment capacity that allows them to separate patients infected with COVID-19 from those who are not affected. CMS's waivers and flexibilities will permit hospitals and health care systems to expand capacity by triaging patients to a variety of community-based locales, including ambulatory surgery centers, inpatient rehabilitation hospitals, hotels, and dormitories. Transferring uninfected patients will help hospital staffs to focus on the most critical COVID-19 patients, maintain infection control protocols, and conserve personal protective equipment. CMS will also 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. In addition, CMS will allow hospital emergency departments to test and screen patients for COVID-19 at drive-through and off-campus test sites.

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Small PAMA Victory in Aid Package, But Labs Remain in 'Untenable Situation'

MedTech Dive

On March 27, President Donald Trump signed the $2 trillion Coronavirus Aid, Relief, and Economic Security (CARES) Act into law. The American Clinical Laboratory Association (ACLA) had requested Congress to allocate $5 billion to reduce the cost burden related to uncompensated COVID-19 testing and rapidly scaling up capacity, and to guarantee government buyback of the equipment and supplies being used to expand testing availability. However, the measure does not include the necessary funding for labs to ramp up coronavirus testing in the United States. ACLA President Julie Khani said on March 25, "Our members remain in an untenable situation, absorbing growing, uncompensated costs for testing specimens with no assurance that they will be appropriately or fairly reimbursed for all the tests they are performing." A breakdown of the bill from the Senate Committee on Health, Education, Labor, and Pensions reveals that it contains $11 billion for diagnostics, treatments, and vaccines and $16 billion for the Strategic National Stockpile via the Public Health and Social Services Emergency Fund. Separately, $80 million is going to the Food and Drug Administration (FDA) for diagnostics, treatments, and vaccines. The bill stipulates that all COVID-19 testing, including those not yet awarded emergency use authorization by FDA, be covered by private insurers without patient cost sharing. In cases when providers and insurers are not contracted, providers must disclose their testing prices. ACLA welcomed the CARES Act's one-year freeze on upcoming major cuts to common lab test reimbursement under the Protecting Access to Medicare Act, which ACLA estimates will ultimately average roughly 30 percent. The CARES Act also adjusts the timing on the reporting period for private payer data and phase-in of reimbursement cuts, which has reduced how much the Centers for Medicare & Medicaid Services pays for testing.

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New Coronavirus Test Tries to Reduce Risk for Health Workers by Letting Patients Swab Selves

Wall Street Journal

UnitedHealth Group is unveiling a COVID-19 test that patients can self-administer. Ken Ehlert, chief scientific officer for UnitedHealth, says the new protocol will be implemented as rapidly as possible at the company's OptumCare network of more than 48,000 physicians. uan-Po Tu, MD, director of infectious diseases at UnitedHealth's Everett Clinic in Washington state, worked with other medical experts from UnitedHealth and elsewhere to conduct a weeklong study. The team reported its findings on March 22 to FDA, which updated its guidance for health care workers to include the method the following day. Officials of UnitedHealth say its study accurately detected COVID-19 in more than 90 percent of patients confirmed as infected, which is consistent with the test administered by a clinician. The study included nearly 500 patients at UnitedHealth's OptumCare facilities. The research was assisted by the Bill & Melinda Gates Foundation, among other organizations. Under the new method, a swab can be administered by the patient at the front of the nose, dropped into a test tube, and returned to health care staff. The patient can do it from inside a vehicle. Tu says, "This is groundbreaking, because it will radically change how the samples are obtained and make the health care worker much safer." The company's coronavirus test is one of several being rolled out by health companies, including a regimen from California-based Cepheid that provides results in 45 minutes.

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