COVID-19

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Earlier this month, in response to the end of the COVID-19 public health emergency, the Department of Health and Human Services (“HHS”) issued the Eleventh Amendment to the declaration under the Public Readiness and Emergency Preparedness Act (“PREP Act”) for medical countermeasures against COVID-19. The PREP Act allows the Secretary of HHS to provide liability immunity, through a declaration, to certain individuals and entities against claims associated with the manufacture, distribution, administration, or use of certain defined medical products or devices, referred to as countermeasures.

HHS originally announced this PREP Act declaration in January 2020 in response to the COVID-19 pandemic (the “Declaration”).  The Declaration has been amended at various points throughout the pandemic.  This latest amendment makes several different updates:…

Continue Reading HHS Amends and Extends COVID-19 PREP Act Declaration

On April 8, 2022, President Biden issued a memorandum ordering his executive departments to take steps to combat the long term effects of COVID-19.

In particular, the memorandum focused on efforts to address the effects of “Long COVID.” The memorandum noted that “Long COVID” symptoms “can include anxiety and depression, fatigue, shortness of breath, difficulty concentrating, heart palpitations, disordered sleep, chest and joint pain, headaches, and other symptoms.” Further, the memorandum also acknowledged that “Long COVID” can affect a wide-range of people regardless of race, ethnicity, underlying conditions, or even severity of original infection.

The memorandum requires the Secretary of Health and Human Services to work with the heads of agencies as well private experts, organizations, and stakeholders to coordinate a government-wide response to “Long COVID.” Further, the Secretary must publish a public report within 120 days regarding government support services available or that will be available to those experiencing “Long COVID,” those experiencing loss because of COVID-19, and those who are experiencing mental health and substance use issues due to the pandemic. The report must also directly address disparities in these services available to underserved communities.
Continue Reading Biden administration announces efforts to combat “Long COVID”

In a notice published on April 7, 2022, the Health Resources and Services Administration (HRSA), the division of HHS that manages the distribution and oversight of CARES Act Provider Relief Funds (PRFs), requested comments from stakeholders on proposed changes to its Information Collection Request (ICR) Form that it will be submitting to the Office of Management and Budget (OMB).

The approved ICR uses an OMB form that is set to expire on January 1, 2023, so HRSA is requesting comments before submitting revisions to OMB. This is the first opportunity for providers who were subject to the first two PRF reporting periods (Period 1 and Period 2) to comment on the reporting program and provide feedback on requirements related to those reports. In addition to revising the PRF reporting form, HRSA is looking to add reporting for the American Rescue Plan (ARP) rural provider program to the ICR.

The ARP rural provider program was put in place by Congress to provide payments to providers and suppliers who served rural Medicaid, CHIP and Medicare beneficiaries from January 1, 2019 through September 30, 2020. The ARP Rural plan is distinct from the PRF, but it has similar reporting requirements and uses the PRF reporting portal for applications.
Continue Reading HRSA asks for comment on provider relief fund and ARP rural reporting requirements

The Department of Health and Human Services (HHS), through its Health Resources and Services Administration (HRSA) office, is taking action to recoup CARES Act funding from health care providers who received relief funding but did not meet the reporting requirements set by HRSA.

To receive COVID-19 relief funding from HRSA pursuant to the CARES Act, providers had to attest to compliance with the terms and conditions promulgated by HRSA. Recipients of the funds must agree to the terms and conditions specific to the Phase in which they received funding distribution. Those terms and conditions evolved over time, with different reporting periods for each wave of funding. Under all waves, failure to report to HRSA regarding the use or allocation of received funds constitutes noncompliance with HRSA’s terms and conditions and requires repayment of the funds.

Providers who completed reporting, but reported unused funds, will have 30 days from the end of their specific reporting deadline to return all unused funds.
Continue Reading Provider relief fund reporting: HRSA to recoup funds from providers who didn’t meet deadlines

The Occupational Safety and Health Administration (“OSHA”) has reopened the comment period on its June 2021 interim final rule establishing an Emergency Temporary Standard governing occupational exposure to COVID-19 in healthcare settings, codified at 29 C.F.R. § 1910 Subpart U (“Healthcare ETS”).

While this reopening reaches certain questions and issues presented by OSHA and not the entire rule, the reopening of the comment period signals the beginning of the effort to finalize a permanent standard by OSHA only three months after the agency withdrew the Healthcare ETS. The Healthcare ETS required healthcare organizations to develop a COVID-19 plan for its workplace that included health screening and management, masking, distancing, and support for vaccination. The Healthcare ETS was withdrawn in December 2021 because OSHA determined that its efforts to establish a permanent standard would exceed the six-month time period allowed under the Occupational Safety and Health Act.

The notice reopening the comment period gives stakeholders both an early view into potential regulatory outcomes of the final rule as well as a series of information requests.
Continue Reading OSHA reopens comments on COVID-19 Healthcare Emergency Temporary Standard

On February 23, 2022, the Federal Bar Association (FBA) kicked off its fifth annual Qui Tam Conference to highlight key areas for False Claims Act (FCA) enforcement in the coming year. The conference opened with a keynote address by Gregory E. Demske, Chief Counsel to the Inspector General, Department of Health and Human Services (HHS), Office of Inspector General (OIG). Then, a series of panels analyzed the FCA-related developments from the prior year, recent efforts by the U.S. Department of Justice (DOJ) to combat cybersecurity fraud, and some of the schemes promoting alleged telehealth fraud during the ongoing COVID-19 public health emergency. Based on the comments of government speakers, all speaking in their individual capacities, below are key takeaways of what we expect the government to prioritize in 2022:

Pandemic-related fraud and telehealth fraud are key targets

Reinforcing the DOJ’s current enforcement priorities, we expect the DOJ to continue to focus its resources and enforcement activity on where it stands to recover the most dollars swiftly: pandemic-related fraud (e.g., misuse of CARES Act relief funds) and telehealth fraud.

During his keynote address, Demske similarly acknowledged these two areas of focus and added Medicare Advantage, the opioid epidemic, and nursing homes as ongoing priorities for OIG enforcement. Notably, Demske cited OIG’s Data Analytics Group as a robust resource for the agency to identify anomalies in large data sets (e.g., outlier distributions of CARES Act provider relief funds) that may lead to targeted enforcement.

For more information about the fraud and abuse implications of CARES Act provider relief funds, as well as practical tips for navigating the evolving CARES Act regulatory environment, please check this Reed Smith client alert.
Continue Reading FBA’s 2022 Qui Tam Conference Puts Annual Spotlight on FCA Enforcement Trends and Developments

UPDATE 1/20/22:

At the request of the state of Texas, the federal court has dismissed that state’s challenge to the Omnibus Covid-19 Health Care Staff Vaccination Rule. As a result, facilities within that state will now be subject to the requirements of the Rule. The CMS has set the following deadlines for compliance within the state:

Phase 1: As of February 22, 2022, all covered individuals must have either completed the initial dose of a primary series of vaccine or applied for an exemption for religious or health reasons.

Phase 2: As of March 21, 2022, all covered individuals must have either completed the primary series of vaccine or been approved for an exemption for religious or health reasons. The employee need not have passed through the two-week post-vaccination period that generally defines complete vaccination; they need only have received their complete series of vaccines.

The CMS Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule survived its initial trip to the U.S. Supreme Court on January 13 with a per curiam decision that stayed injunctions placed on the rule by federal district courts in December.

The Supreme Court took the rare action of holding oral argument and then issuing a full opinion (with dissents) on the emergency stay application that had been brought by the Centers for Medicare & Medicaid Services, asking the Court to allow the agency to enforce the rule while challenges to its validity continue in the lower federal courts.

The Court was definitive that the rule as published falls within the authority of the Secretary of Health and Human Services to promulgate based on the statutory authority conferred by Congress through the Social Security Act (SSA). Specifically, the court found that the various statutory provisions within the SSA allow the Secretary to impose conditions of participation on the receipt of Medicare and Medicaid funds that are necessary in the interest of the health and safety of individuals who furnish services reimbursable under those programs and the federal program beneficiaries that they serve.

However, the Court’s opinion still leaves some questions unanswered about whether the rule will be enforceable in Texas and whether eventually some facilities may be exempted.…

Continue Reading CMS health care staff vaccination rule enforceable as challenges continue UPDATED

The Centers for Medicare and Medicaid Services (CMS) has published an interim final rule that changed the conditions of participation in Medicare and Medicaid to require vaccination of certain healthcare workers. The rule, title “Omnibus COVID-19 Health Care Staff Vaccination Rule” was published in the Federal Register on November 5, 2021.

The rule requires all employees of certain health care entities that are regulated by CMS to obtain their first vaccination shot or apply for a religious or other health or disability related exemption by December 6, 2021. Additionally, the rule requires either completed vaccination series or approved exemption by January 4, 2022.

Covered Entities and Individuals

The rule is not a blanket vaccine mandate for all health care workers and Medicare sites of service as had been speculated in various media reports. Instead the rule is limited to only those entities who are surveyed by CMS and have Conditions of Participation, Conditions for Coverage, or Requirements for Participation in the Medicare and Medicaid programs.…

Continue Reading CMS issues interim final rule on SARS-CoV-2 vaccination for health care workers

On August 1, 2021, the Senate released the legislative text of the bipartisan infrastructure bill, the “Infrastructure Investment and Jobs Act,” H.R. 3684.  The Senate is expected to vote this week, before a month-long recess beginning on August 9, 2021.  The 2,702 page legislation contains several relevant health care-related provisions, including a delay of the implementation of the rule eliminating the Anti-Kickback Statute (“AKS”) safe harbor protection for Medicare Part D rebates.

Rebate for Discarded Amounts of Medicare Part B Single-Dose Container or Single-Use Package Drugs

First, the legislation requires manufacturers of single-dose container or single-use package drugs payable under Medicare Part B to provide a rebate to the government for any discarded portion of that drug.  The rebates will be charged each quarter, beginning with the first quarter of 2023, and must be paid in regular intervals, as determined appropriate by the Secretary of the U.S. Department of Health and Human Services (“HHS”).  The legislation provides that, in order to enforce this provision, HHS will conduct periodic audits of both drug manufacturers and providers who submit claims.  For violations of this provision, HHS will impose Civil Monetary Penalties in amounts equal to the sum of the amount that the manufacturer would have paid and twenty-five percent of such amount.…

Continue Reading Health Care Provisions in the Infrastructure Investment and Jobs Act

Over the last decade, members of the medical and public health communities around the world have widely studied and acknowledged the impact of social determinants of health (SDOH)—the conditions in the environments where people live, learn, work, play, and age—on a wide range of health, functioning, and quality-of-life-risks and outcomes.[1]  In the past year…

On July 1, 2021, the U.S. Department of Health and Human Services (“HHS”), through the Health Resources and Services Administration (“HRSA”) notified recipients of Provider Relief Fund (“PRF”) payments via e-mail that the PRF Reporting Portal is now open for providers who are required to report on the use of funds in Reporting Period 1…

On June 11, 2021, the Department of Health and Human Services (“HHS”) announced that it had released revised reporting requirements for those providers and suppliers that have received Provider Relief Fund payments during the COVID-19 pandemic. Readers may recall that HHS previously issued notices on post-payment reporting requirements starting in July 2020, and that previous…

On May 18, 2021, in a statement issued by the U.S. Department of Health and Human Services’ (HHS) Office of Inspector General, Acting U.S. Attorney for the Eastern District of California, Phillip Talbert, and California Attorney General, Rob Bonta (the Statement), the health care industry was reminded of the prohibition against charging individuals for COVID-19…

The 2019 Novel Coronavirus pandemic (“COVID-19”) introduced several unfamiliar hardships adversely impacting the long-term care industry, especially for nursing homes.  Acknowledging these hardships, the Centers for Medicare & Medicaid Services (“CMS”) enacted several temporary emergency blanket waivers effective March 1, 2020, lending flexibility to nursing homes in their COVID-19 response efforts.  Since that time, according…

During a press conference on Monday, March 29, 2021, Florida Governor Ron DeSantis signed Senate Bill 72, which grants civil immunity to corporations, hospitals, nursing homes, government entities, schools, and churches from COVID-19-related lawsuits, except in cases of gross negligence or intentional misconduct.  Plaintiffs who file suit in Florida alleging coronavirus-related injuries will face…

It is no secret that the coronavirus pandemic has driven our daily lives digital—work, education, social gatherings, and, of course, health care. Congress and CMS responded to the public health emergency by waiving limitations on reimbursement for telehealth services rendered to Medicare patients. These waivers introduced new flexibility and vastly expanded Medicare patients’ access to…

On January 28, 2021, the White House issued President Biden’s Executive Order on Strengthening Medicaid and the Affordable Care Act (the “Executive Order”), which seeks to increase access to affordable health insurance and strengthen Medicaid and the Affordable Care Act, particularly in light of the ongoing COVID-19 pandemic.  In addition to this Executive Order, the…

On the last full day of the Trump Administration, the Department of Justice (DOJ) submitted a statement of interest in litigation supporting the position that the Public Readiness and Emergency Preparedness (PREP) Act preempts legal claims relating to the administration or use of covered countermeasures with respect to a public health emergency and, therefore, makes…

In the evening of December 21, 2020, both Houses of Congress passed the Consolidated Appropriations Act, 2021, H.R. 133.  The sprawling, 5,593-page legislation includes the most significant health care-related provisions to be passed since the CARES Act.  The President is expected to sign the legislation shortly.  Of note, in the course of appropriating billions of…