On March 23, 2020, Governor Phil Murphy signed Executive Order 109, which “limit[ed] non-essential adult elective surgery and invasive procedures, whether medical or dental, [in order to] assist in the management of vital healthcare resources during this public health emergency.” The purpose of EO 109 was to “limit exposure of healthcare providers, patients, and staff to COVID-19 and conserve critical resources such as ventilators, respirators, anesthesia machines, and Personal Protective Equipment (‘PPE’) [that] are essential to combatting the spread of the virus.” At the time EO 109 was executed, coronavirus cases were rapidly increasing within the State. On March 23rd, New Jersey had 2,844 coronavirus cases in all 21 counties, an increase of 935 over the previous day, and at least 27 people had died.
To address the COVID-19 public health emergency fiscal burdens, Congress authorized and appropriated the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act, Public Health and Social Services Emergency Fund (“Relief Fund”) for healthcare providers and facilities. The Department of Health and Human Services (“HHS”) has begun to distribute several tranches of the Relief Funds. All totaled, Congress provided $175 billion to the Public Health and Social Services Emergency Fund (“Relief Fund”) through the CARES Act and the Payroll Protection Program and Health Care Act.
One of the many relief efforts contained in the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), signed into law on March 27th, 2020, is a hiatus of sequestration as it applies to Medicare payments. Section 4408 of the CARES Act exempts Medicare from the effects of sequestration from May 1, 2020, through December 31, 2020. It also postpones the sunset of sequestration as it applies to Medicare from the end of 2029 to the end of 2030.
HHS Relief Fund’s Terms and Conditions Certifications, Acknowledgments and Reports Public Disclosure of Payments
The CARES Act, passed by Congress and signed into law on March 27, 2020, provides $100 billion for the Public Health and Social Services Emergency Fund (“Relief Fund”) to support eligible health care providers. Less than a month later, Congress passed the Payroll Protection Program and Health Care Act, providing an additional $75 billion to the Relief Fund, raising the total funds available to $175 billion. As of the end of April 2020, the Department of Health and Human Services (“HHS”) released to providers two tranches of Relief Funds totaling $50 billion. HHS disbursed the first $30 billion tranche (“Tranche 1”) between April 10 and April 17, 2020. Currently, HHS is disbursing the second $20 billion tranche (“Tranche 2”). Because these are grant funds – not loans – repayment is not required. What HHS requires is that the Recipients attest to and follow the Relief Fund’s Terms and Conditions. Before we turn to the Terms and Conditions, it is important to understand HHS’ Relief Fund disbursement process.
This article on the sweeping and urget changes in the telehealth space has been updated to reflect the April 30, 2020, press release by the Centers for Medicare & Medicaid Services (CMS) announcing expanded Medicare payments and coverage for telehealth services.
Congress has passed the Paycheck Protection Program and Health Care Enhancement Act, increasing the total amount available under the Paycheck Protection Program by $310 billion. Of that sum, $60 billion is set aside for loans to be made through small and very small community banks and credit unions. The bill also includes an increase of $10 billion for EIDL grants, $75 billion to help overwhelmed providers and hospitals, and $25 billion for coronavirus research.
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.
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.
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.
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.”