Category Archives: Coronavirus

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Summary of Key Provisions of Interim Final Rule: CMS Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency

On March 30, 2020, the Centers for Medicare and Medicaid Services (“CMS”) announced an Interim Final Rule with Comment Period (the “IFC”) to address numerous regulatory and administrative changes in response to the COVID-19 pandemic. This Interim Final Rule was announced in conjunction with many other revisions and relaxations, and in addition to previously issued … Continue Reading

CMS Issues COVID-19 Prevention Guidance for PACE Organizations

On March 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued a memorandum to provide information to organizations that participate in the Programs of All-Inclusive Care for the Elderly (“PACE”) program in furtherance of preventing the spread of the 2019 Novel Coronavirus (“COVID-19”).… Continue Reading

CMS “Hospitals Without Walls” Waiver: Looking To ASCs to Provide Relief

On March 30, 2020, CMS through its blanket 1135 waiver authority[1] implemented a “Hospital without Walls” policy to allow hospitals to provide and bill for hospital services in other healthcare facilities and sites, such as ambulatory surgery centers (“ASCs”).  The waiver is intended to ensure that local hospitals and health systems have the capacity to … Continue Reading

SEC Guidance on COVID-19 Disclosures for Healthcare Providers

On March 25, 2020, the Division of Corporate Finance of the Securities and Exchange Commission published guidance on disclosure obligations of companies with respect to COVID-19 and related disruptions. The SEC recognizes that the full impact of COVID-19 on any company or industry may be difficult to predict, but such effects may still be material … Continue Reading

CMS’ Blanket Waiver of Stark Law Sanctions During the COVID-19 Outbreak: Opportunities and Limitations

On Monday, March, 30, 2020, CMS released a blanket waiver (the “Waiver”) of the physician self-referral law under section 1135 of the Social Security Act to enable health care provider responses to the COVID-19 outbreak.  Effective retroactively to March 1, 2020, the Waiver broadly eliminates certain key Stark Law requirements for direct financial relationships between … Continue Reading

Highlights From The Wall Street Journal’s Health Forum

The Wall Street Journal’s Health Forum convened—virtually—on March 24th during an extraordinary period in global health: the novel coronavirus is threatening populations, overwhelming provider systems, and sending economies into uncharted territory. The interactive event assembled executives, investors, health professionals, industry experts, and leaders in health policy to provide insight into managing the crisis. Sheppard Mullin … Continue Reading

Strategies in Responding to COVID-19: Expanding Scope of Practice to Increase Patient Access to Healthcare

As the COVID-19 pandemic continues and our health system is pushed to and beyond capacity, lawmakers and stakeholders are assessing different ways to handle the incredible volume of patients suddenly needing care. One approach being examined, largely at the state level although supported at the federal level, is expanding the scope of practice for different … Continue Reading

Personal Protective Equipment & Ventilators: How FDA Is Increasing Supply for the US Healthcare System

In light of the widely reported shortage of personal protective equipment (PPE), ventilators, and other medical devices, the U.S. Food and Drug Administration (FDA) is working around the clock to authorize medical supplies for the US healthcare system, including relaxing its rules for importing and distributing PPE and ventilators and their accessories (e.g., vent splitters … Continue Reading

Speeding Up and Slowing Down Antitrust Reviews – How the Federal Antitrust Agencies Are Responding to the COVID-19 Crisis

Make no mistake, the antitrust laws remain in full effect.  The leadership of the Antitrust Division of the Department of Justice (“DOJ”) and the Federal Trade Commission (“FTC”) have made clear that these enforcers “stand ready to pursue civil violations of the antitrust laws, which include agreements between individuals and business to restrain competition through … Continue Reading

Key Health Care Provisions of the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”)

On Friday, March 27, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) was enacted.  Organized below are concise summaries of select CARES Act sections that will impact various sectors of the health care industry:… Continue Reading

Coronavirus Aid, Relief, And Economic Security Act Of 2020: Telehealth Front and Center

The Sheppard Mullin Healthcare Law Blog has included many blog articles over the last weeks and months regarding telehealth.  As our most recent blog articles show, telehealth is playing an important role in the COVID-19 pandemic – telehealth is a natural-born solution to the problem of providing healthcare while meeting the challenges of social distancing.… Continue Reading

Key Provisions in the Senate Stimulus Bill

On March 25, 2020 the Senate passed a $2 trillion stimulus bill “[p]roviding emergency assistance and healthcare response for individuals, families and businesses affected by the 2020 coronavirus pandemic.”  The House and the President are both expected to approve the Bill in short order.  The Bill contains many provisions important to all companies, including government … Continue Reading

Top 10 Questions Asked By Medical Group Clients In Response To COVID-19

In response to COVID-19, medical groups are doing their best to care for patients and ensure the safety of their contracted and employed healthcare providers in the face of this new virus. Given the scope of the virus and the questions it raises for medical groups, Sheppard Mullin has prepared, “COVID-19: Legal Guide for Medical … Continue Reading

COVID-19 — Legal Guide for Medical Groups

This COVID-19 – LEGAL GUIDE FOR MEDICAL GROUPS (“Guide”) provides a general discussion of legal issues confronting medical groups as a result of COVID-19, including employee protections, infection control, and reporting obligations, workforce management and related mitigation strategies, employee obligations, business and payor relationships, privacy and telehealth, Medicare changes, and strategic transactions.… Continue Reading

U.S. Antitrust Agencies to Streamline Review for COVID-19 Collaborations

On Monday, March 23, it was reported that the U.S. Department of Justice (DOJ) and Federal Trade Commission (FTC) were preparing to announce a streamlined procedure through which companies seeking to collaborate on a response to the coronavirus pandemic may obtain an expedited review and approval of their contemplated venture.  (https://www.bloomberg.com/news/articles/2020-03-23/u-s-to-speed-antitrust-reviews-for-firms-teaming-up-on-virus).  Specifically, the DOJ and … Continue Reading

Bringing Clarity to Section 1135 and Other Waivers amid the COVID-19 Emergency

On a daily basis, if not more frequently, we are astounded by our clients’ efforts to prepare for and respond to the COVID-19 pandemic.  As the federal government works to respond to the COVID-19 pandemic, guidance from HHS and CMS with respect to waiver of Social Security Act requirements has been rapidly evolving, seemingly overlapping, … Continue Reading

Presidential Executive Order Calls on HHS to Issue Priority Contracts and Allocate Scarce Medical Resources

On March 18, 2020, the President issued an Executive Order on Prioritizing and Allocating Health and Medical Resources to Respond to the Spread of COVID-19 (the “EO”). The EO was issued pursuant to the Defense Production Act of 1950 (50 U.S.C. §4501 et seq.) (“DPA”), which allows the President to invoke special Federal Contracting powers … Continue Reading

Guard Against False Claims as Massive Government Spending Rolls Out to Combat COVID-19

Introduction Federal and state governments are ready to roll out over one trillion dollars in funding in response to the novel coronavirus (COVID-19) pandemic.  As past is often prologue, we expect this new round of massive government spending to someday be subjected to strict government oversight, targeted audits and investigations, and whistleblowers all searching for … Continue Reading

Families First Coronavirus Response Act Imposes Benefit Mandates on Insurers and Group Health Plans

In a much needed sign of bipartisanship, the Senate passed and President Trump signed last night  the Families First Coronavirus Response Act.  The new law is effective today and requires insurers and group health plans to provide coverage for FDA-approved COVID-19 testing and related items and services.  The mandated coverage applies during the current state … Continue Reading

California Health Plans Take Note: California Department of Managed Health Care issues All Plan Letter on Social Distancing and COVID-19

On Thursday, March 12, 2020, the California Department of Managed Health Care (the “Department”) released a guidance letter (the “Letter”) to all health care service plans regarding the coronavirus (COVID-19) pandemic. The Letter encourages plans to take certain steps to promote social distancing to decrease in-person visits during the delivery of health care services.  The … Continue Reading
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