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 waivers, that CMS has made in the midst of the COVID-19 emergency in an effort to provide health care practitioners and providers with flexibility in safely getting patients the care they need.  We have summarized the Interim Final Rule’s key changes here.   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 handle the anticipated surge of COVID-19 patients through the duration of the public health emergency (“PHE”).  See, “CMS Issues Temporary Waivers in Broad Coronavirus Response,” as posted on April 2,2020 on this blog for general information regarding the March 30, 2020 1135 waiver. Continue Reading

CMS Issues Temporary Waivers in Broad Coronavirus Response

On March 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a series of temporary regulatory waivers in order to aid the response to the 2019 Novel Coronavirus (COVID-19), as follows. 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 to stockholders, and so it provided some detail on the obligations of companies to report such items. Continue Reading

CMS Releases Interoperability Rule Designed to Increase Patient Access to Health Information

On March 9th, the U.S. Department of Health and Human Services (HHS) finalized two rules that are designed to give patients access to their health data and to increase interoperability among health care providers and payers using health information technology.  The two rules, issued by the HHS Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare & Medicaid Services (CMS), implement interoperability and patient access provisions of the 21st Century Cures Act.  A primary aim of the 21st Century Cures Act was to push the healthcare industry to facilitate interoperability of healthcare data across the spectrum, including amongst health care payers, providers, patients and technology vendors.  For decades, HHS has largely relied on the industry to enable interoperability through a market-driven approach that would, in theory, benefit industry while achieving the interoperability goals established by the regulators. Unfortunately, it has been observed that the theory behind a market-driven approach has not been manifested in reality. In reality, the market-driven approach has allowed industry to monetize data by limiting data sharing and, in turn, impeding the benefits of interoperability which rely upon data sharing to promote improved care coordination, better patient outcomes, and material cost reductions. In order to bend the curve toward interoperability, the new HHS rules are designed to provide for binding and specific steps to “free” health care data and recognize the aforementioned benefits. 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 entities that provided designated health services (“DHS”) and physicians and physician organizations (or immediate family members of physicians).  The Waiver will provide tremendous comfort and flexibility to health care providers attempting to respond rapidly and effectively to the COVID-19 outbreak by lowering many administrative hurdles to and other restrictions on effectuating critical financial relationships.  Providers seeking to operate under the Waiver, however, should be mindful of its limitations in proceeding with their COVID-19 response plans. 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 attended the Forum and has summarized below some of the outstanding content covered throughout the day. 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 types of individual health care providers. 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 for multiple patient ventilation).  FDA’s policies on permitting uncleared medical devices shift daily toward greater relaxation of regulatory hurdles for suppliers and manufacturers.  The most recent policies on PPE importation and use in healthcare settings create more options for healthcare providers and patients in need of ventilatory support and help alleviate bottlenecks of necessary medical supplies in the supply chain. Continue Reading

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