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Michael W. Paddock is a partner in the Corporate Practice Group in the firm's Washington D.C. office.

As the COVID-19 emergency continues to heavily impact the U.S. and its health care system, CMS has issued additional flexibilities for providers and payors seeking to respond to the pandemic.  These new flexibilities are described both in revisions to CMS’ blanket waivers and in a new Interim Final Rule with comment period, both issued on April 30.  Many of these flexibilities are responsive to questions and requests submitted to CMS over the past few weeks, providers’ experiences with developing and implementing pandemic response plans, and the regulatory obstacles they have encountered.  While these new flexibilities will not eliminate all of the regulatory challenges currently facing providers responding to COVID-19, and providers must be careful to continue to track the scope of CMS’ flexibilities, they will be very helpful to many providers in their ongoing COVID-19 response efforts.  In particular, and among other things, CMS’ new guidance expands flexibility for telehealth services, provides additional support for COVID-19 testing, relaxes additional regulatory requirements applicable to certain payors, provides other key regulatory flexibilities, and offers guidance to MSSP ACOs on payment calculations for periods affected by the public health emergency.
Continue Reading CMS Updates Waivers, Provides More Flexibility for Providers Responding to COVID-19

On April 21, 2020, the Centers for Medicare and Medicaid Services (“CMS”) released “Explanatory Guidance” related to the March 30, 2020 Blanket Waivers of Section 1877(g) of the Social Security Act (information about those waivers available in our previous blog post here), applicable during the COVID-19 public health emergency (“PHE”). The Explanatory Guidance clarifies the scope and application of the Blanket Waivers to certain financial relationships and responds to some of the issues raised by stakeholders since the release of the Blanket Waivers. The Explanatory Guidance offers some new insight, which providers should consider in structuring any arrangements that rely on the Blanket Waivers, but leaves many key questions and challenges unaddressed.
Continue Reading Even in a Crisis, Stark Law Compliance Demands Attention: CMS Issues Explanatory Guidance on Stark Law Blanket Waivers

On Friday, April 10, 2020, the Department of Health and Human Services (“HHS”) began distributing $30B of the $100B appropriated in the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act to the Public Health and Social Services Emergency Fund (“PHSSEF”), also called the “CARES Act Provider Relief Fund”.  HHS distributed the funds to providers based on their 2019 Medicare fee-for-service (“FFS”) reimbursement.  We understand that $26B of this $30B have already been directly deposited into providers’ accounts. Many providers have questions about what happens next.  We address the top ten questions here.
Continue Reading HHS Distributes First $30B of CARES Act Provider Relief Fund – What Providers Need to Know and Do Next

The Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) provides many avenues of potential funding relief for health care providers and suppliers who are suffering increased expenses and lost revenues as a result of the coronavirus pandemic.  Some of these funding opportunities may or will require affirmative action by a health care provider or supplier, e.g., the submission of an application for relief.  Other funding mechanisms will go into effect without additional provider action.  Set forth below is a summary description of these opportunities.
Continue Reading Increased Expenses and Lost Revenues? CARES Act Funding Opportunities for Health Care Providers and Suppliers

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

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

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

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, and emitting from various agencies, leaving many confused about the scope and applicability of the waivers, whether one “supersedes” another, as well as whether any affirmative steps need to be taken in order to “procure” or properly operate under the terms of a waiver.  To help resolve any confusion, outlined below is a summary of the authority for these waivers, how they work together, how and when they apply, and where gaps remain.  We are available to answer your questions as you continue to develop your organization’s COVID-19 preparedness and response plan.

 Coronavirus, COVID-19 pandemic
Continue Reading Bringing Clarity to Section 1135 and Other Waivers amid the COVID-19 Emergency

As the coronavirus strain (COVID-19) continues to spread, the government, insurance companies and medical providers are rushing to find paths to more efficiently and effectively provide care for those in need. The Centers for Disease Control and Prevention (“CDC”) warns that the virus is spread mainly from person to person and that people are most contagious when they are most symptomatic.
Continue Reading Telehealth and Federal and State Government Responses to the Coronavirus Pandemic