Background

The U.S. Department of Health and Human Services (HHS) recently finalized transformative rules that will give patients unprecedented safe, secure access to their health data. The rules are issued by the HHS Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare & Medicaid Services (CMS) to implement interoperability and patient access provisions of the bipartisan 21st Century Cures Act (Cures Act).  These final rules mark the most extensive healthcare data sharing policies the federal government has implemented, requiring both public and private entities to share health information between patients and other parties while keeping that information private and secure. These final rules became effective as of June 30, 2020. NOTE: Due to the COVID-19 public health emergency, HHS has delayed enforcement until future dates. Continue Reading How HHS Information Blocking Regulations Apply to Healthcare Providers

Regulatory developments—such as the Stark Law blanket waivers and the OIG’s enforcement deferral for use of the waivers—have helped healthcare providers during the COVID-19 crisis, but healthcare fraud remains a prime target of the DOJ and the OIG (in addition to state regulators).  Between October 2018 and September 2019, the DOJ obtained over $3 billion in judgments and settlements from fraud claims, a substantial portion of those claims relating to healthcare fraud.[1]  The significant increase in qui tam litigation since the 1980s is also notable.[2]  So what fraud and abuse actions could regulators pursue in COVID-19’s shadow? Continue Reading Do Covid-19 Regulatory Changes Pose an Increased Risk of Fraud and Abuse Liability for Healthcare Providers?

Among the multitude of relief options under the CARES Act, the U.S. Department of Health & Human Services (HHS) allocated provider relief funds (PRF) to healthcare providers.  Phase I in late April saw healthcare providers receive $50 billion in general PRF distributions, largely based on historical Medicare volume or net revenues.  Phase II followed in early May with general PRF distributions of $15 billion for Medicaid, Children’s Health Insurance Program (CHIP), and dental providers.  And continuing after that, HHS issued some $52 billion in targeted PRF distributions among: (1) hospitals treating large numbers of COVID-19 patients; (2) rural providers; (3) skilled nursing facilities; (4) safety net hospitals; and (5) tribal healthcare providers.  All in all, HHS issued $175 billion in PRF to support healthcare providers.

Continue Reading If You Received Provider Relief Funds Under the CARES Act, Are You Preparing Adequate Support for Your Use of the Funds?

On August 4, 2020, the Office of Inspector General of Health & Human Services (OIG) used a new website resource to share informal guidance on the ability of laboratories to provide free COVID-19 antibody testing to Medicare beneficiaries.  For the specific situation, the requestors indicated that the clinical lab would provide free COVID-19 antibody testing to patients—including federal healthcare program beneficiaries—in conjunction with other medically necessary blood tests performed by the lab.  The lab indicated that it would not charge any patient or other payors for the COVID-19 antibody tests offered in conjunction with other paid lab tests.  The requestors also indicated that the purpose of the arrangement had a public health focus as it was intended to increase patient awareness of antibodies to promote donations of COVID-19 blood plasma, which can be used for certain experimental convalescent plasma therapy treatments for COVID-19.

Continue Reading OIG Approves Free COVID-19 Antibody Testing for Medicare Beneficiaries

On June 30, 2020, Winstead PC attorney Sarah Churchill Llamas participated in a panel discussion—How to Increase Enterprise UX?—as part of the UX & Telehealth RapidConf. Discussions centered on telehealth and its overall market-effect in the rapidly evolving healthcare landscape. The panel was hosted by Fabien Beckers (Arterys), and included other panelists such as Laura Berrara (ECG Management), John Fryer (Lumeris), and Balint Bene (bene : studio). Here are a few key takeaways from the discussion:

Continue Reading UX & TeleHealth RapidConf | Key Takeaways

It is difficult to identify any aspect of everyday life that the global COVID-19 pandemic has not, in some way, impacted or altered. As the healthcare community valiantly responds and adjusts to the myriad challenges associated with the novel coronavirus, individual patients have also been forced to rearrange in the midst of the public health crisis. For healthcare providers and patients, COVID-19 has upended many aspects of life that not long ago seemed rather stable and relatively predictable, such as education, travel, employment, entertainment, shopping, finances and social gatherings. A disruption of this magnitude has spurred innovation in the delivery of medical care.  At the same time, providers should be mindful of recent studies indicating nearly half (45%) of adult Americans report having their mental health negatively impacted due to COVID-19[1], demonstrating an increase in the need for behavioral and mental health treatment and services during the public health crisis.

Continue Reading Considerations for Telehealth Providers When Developing Policies and Procedures for Treating Patients with Behavioral/ Mental Health Warning Signs

The past few years have seen an unprecedented number of bankruptcies in the healthcare space, primarily from hospitals and senior living operators.  The pressure placed on healthcare operating companies will only increase as they deal with the effects of the COVID-19 pandemic and continued downward pressure on reimbursements.  As the owner of the real estate leased to these operators, the landlord has a large stake in the success of the healthcare business being conducted on its premises, and needs to understand the drivers of the underlying business model in order to assess the risk profile of the tenant operator.  This understanding should allow the landlord to detect the early warning signs of distress and take proactive steps toward nursing the operator back to health.  While a failing tenant is not the landlord’s fault or responsibility, it often does become the landlord’s problem, and a landlord with healthcare tenants has many factors to consider that landlords of other asset classes do not.  This article will address the unique nature of the healthcare tenant/operator, as well as some strategies and tactics for landlords to consider when working with a troubled healthcare tenant.

Read the full article.

On Friday May 22, HHS announced its decision to award funding in the amount of $50,000 per skilled nursing facility (SNF) with an additional $2500 per licensed bed as part of the Coronavirus Aid, Relief, and Economic Security (CARES) Act stimulus package in response to the COVID 19 crisis.  This funding is intended to address critical needs such as increased testing capacity, increased labor costs, acquisition costs related to personal protective equipment and other expenses linked directly to the COVID-19 pandemic.  SNFs have forty-five (45) days from receipt of the funding to attest to the terms and conditions on the HHS portal. Failure to timely attest is considered automatic acceptance of the terms and conditions.

Continue Reading HHS Announces COVID Funds for Skilled Nursing Facilities