Tag Archives: COVID-19

CMS unveils additional COVID-19 LTC facility testing and reporting rules during public health emergency

On August 27, 2020, the Centers for Medicare & Medicaid Services (“CMS”) filed an interim final rule with comment period (“IFC”), detailing new long-term care (“LTC”) facility COVID-19 testing requirements and strengthening enforcement of existing related facility reporting requirements.  According to CMS, the IFC represents the agency’s latest effort in an ongoing initiative to control … Continue Reading

Reliance on telehealth ramps up during COVID-19, and may be here to stay

As technology has advanced over the years, there has been a corresponding push for virtual visits with health care providers.  In fact, many state boards of medicine and other regulatory agencies have sought to amend regulations and guidances to make telehealth a reality for patients across the U.S.  However, despite the technical allowance for telehealth, … Continue Reading

FDA issued guidance on statistical considerations for clinical trials during the COVID-19 public health emergency

On June 17, the Food and Drug Administration (FDA) continued its efforts to mitigate COVID-19’s disrupting impact on clinical trials by issuing guidance on statistical considerations for changes to trial conduct (FDA previously relaxed restrictions on protocol modifications). As expected, public health measures designed to control COVID-19’s rapid emergence as a global pandemic—social distancing, travel … Continue Reading

HHS announces another round of CARES Act funding for Medicaid and CHIP providers as well as Safety Net Hospitals

On June 9, 2020, the U.S. Department of Health and Human Services (HHS) announced additional distributions from the CARES Act Provider Relief Fund to several groups of providers, totaling approximately $25 billion. $15 billion of these funds is targeted towards eligible Medicaid and Children’s Health Insurance Program (CHIP) providers participating in state Medicaid and CHIP … Continue Reading

CMS announces increased penalties and oversight for states and nursing homes during COVID-19 emergency

On June 1, 2020, the Centers for Medicare & Medicaid Services (CMS) unveiled new measures designed to enhance enforcement and oversight of nursing homes and related state survey agencies.  CMS announced the new policies concurrently with the release of federal data detailing the incidence of nursing home COVID-19 infections, which was also made available on … Continue Reading

OIG releases strategic plan for oversight of COVID-19 response

Following the distribution of billions of relief aid to healthcare providers and amidst the guidance issued around reopening of nursing homes throughout the country, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) unveiled a COVID-19 Response Strategic Plan on May 26, 2020 after updating its Workplan a few days earlier. … Continue Reading

CARES Act Relief Funds: HHS continues rolling updates to FAQs and extends attestation deadline by another 45 days

On May 21, 2020, the U.S. Department of Health and Human Services (HHS) issued additional guidance, by again updating its FAQs, for Medicare providers and suppliers (collectively, providers) receiving relief from the Public Health and Social Services Emergency Fund. Of the $175 billion appropriated by Congress, HHS has allocated $50 billion for general distribution to … Continue Reading

HHS Office of General Counsel advises that the PREP Act preempts state and local requirements that prevent pharmacists from testing for COVID-19

Earlier this week, the Department of Health and Human Services (HHS) Office of General Counsel issued Advisory Opinion 20-02, which declared that the Public Readiness and Emergency Preparedness Act (PREP Act), combined with the HHS Secretary’s March 10, 2020 declaration, preempts state or local requirements that would prevent pharmacists from ordering or administering COVID-19 tests … Continue Reading

Nursing homes face increased scrutiny by attorneys general during COVID-19

Pennsylvania Attorney General Josh Shapiro announced on May 12, 2020, that his office is investigating several nursing homes in the Commonwealth for neglect of patients and residents: “We will hold nursing facilities and caretakers criminally accountable if they fail to properly provide care to our loved ones … we will not tolerate those who mistreat … Continue Reading

CMS issues nursing home reopening recommendations for state and local officials

With portions of the country beginning to reopen, on May 18, 2020, the Centers for Medicare & Medicaid Services (CMS) issued its recommendations to state and local officials for best practices regarding the reopening of nursing homes. Because nursing homes have been severely impacted by COVID-19, CMS issued a memorandum to state officials regarding the … Continue Reading

CMS releases additional COVID-19 blanket waivers for health care providers

On May 11, 2020, the Centers for Medicare & Medicaid Services (CMS) released a new suite of blanket waivers for hospitals and other health care providers in response to the COVID-19 public health emergency.[1] The blanket waivers have a retroactive effective date of March 1, which extends through the end of the public health emergency … Continue Reading

CARES Act Relief Funds: HHS updates General Distribution Fund FAQs and extends attestation deadline from 30 days to 45 days

On May 6, 2020, the U.S. Department of Health and Human Services (HHS) issued additional guidance, by way of updated FAQs, for providers receiving relief from the $50 billion general allocation of the Public Health and Social Services Emergency Fund (known as the Provider Relief Fund) that was appropriated in the Coronavirus Aid, Relief, and … Continue Reading

U.S. Department of Education releases higher education grants under CARES Act, but also invokes False Claims Act

Academic medical centers and other health care entities operating within institutes of higher education need to be aware of the compliance risks surrounding the recent release of higher education grants under the CARES Act. On April 21, 2020, the U.S. Department of Education (Department of Education) announced the release of $6.2 billion in connection with … Continue Reading

Sweeping “CARES Act” Legislation Will Have Wide Impact on Health Care, Life Sciences Companies

The recently passed “Coronavirus Aid, Relief, and Economic Security Act” (CARES Act) is sweeping legislation that will have widespread impact on companies in the health care and life sciences space. In addition to expanding coverage of COVID-19 testing and preventive services, the Act includes provisions to address health care workforce needs, eases restrictions surrounding telehealth … Continue Reading

HHS expands access to telehealth services in response to COVID-19

As discussed in our client alert, recent legal developments have greatly expanded funding for and access to telehealth services during the COVID-19 crisis. Among the changes instituted by HHS are expanded Medicare coverage and payment for services, reduced or waived cost-sharing obligations for physicians, and loosening of the HIPAA enforcement policies for covered entities (which … Continue Reading

CMS Offers Guidance to Health Care Providers on Limiting Elective Surgeries, Other Nonessential Procedures During Coronavirus Outbreak

In a recent guidance, the Centers for Medicare & Medicaid Services (CMS) encouraged health care providers (HCPs) to limit elective surgeries and nonessential procedures during the 2019 novel coronavirus (COVID-19) outbreak. CMS offered a number of recommendations to help HCPs decide how to best serve patients requiring emergent or urgent attention. In addition to clinical … Continue Reading

MedPAC recommends Medicare payment updates for 2021 – but all rate bets are off in light of COVID-19

The Medicare Payment Advisory Commission (MedPAC) released its 2021 Medicare provider rate update recommendations on March 13, 2020 – the same day President Trump declared a national emergency due to COVID-19.  MedPAC’s recommendations were based on an assessment of various Medicare “payment adequacy indicators” that are unlikely to reflect the state of the health care industry in … Continue Reading

CDC Offers Guidance to Health Providers on ICD-10 Coding for Coronavirus/COVID-19 Encounters

The Centers for Disease Control and Prevention (CDC) recently released official diagnosis coding guidance for health care encounters and deaths related to the 2019 novel coronavirus (COVID-19), potentially in anticipation of more frequent cases in the United States. The guidance identifies specific ICD-10-CM codes to be used to code encounters. CDC advises that patients presenting … Continue Reading

Potential Tensions Lie Ahead Between Federal and State Authorities Over the Application of CDC Quarantine Powers

According to the U.S. Centers for Disease Control and Prevention (CDC), although there have been imported cases of Covid-19 detected in the United States, “at this time, the virus is NOT currently spreading in the community in the United States.”[1]  However, on Tuesday, February 25, 2020, Nancy Messonier, the CDC’s Director of National Center for … Continue Reading

Analysis:  Navigating US federal and state rules during the novel coronavirus public health emergency

The novel coronavirus (2019-nCoV, also known as “SARS-CoV-2”) has been declared a public health emergency (PHE) by the U.S. Department of Health and Human Services (HHS).  This designation authorizes HHS to direct funding to: (1) enable the dissemination of information about the virus; (2) encourage research and development of diagnostic and treatment techniques; (3) improve … Continue Reading
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