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Erica Kraus is an associate 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

When Alex Azar, the Secretary of the Department of Health and Human Services (“DHHS”), declared a national emergency on January 31, 2020 in response to the COVID-19 pandemic, he triggered an exception to the “in-person medical evaluation” requirement for online prescribing as set forth in the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Haight Act”).  In short, the Haight Act prohibits physicians and other prescribers from issuing a valid prescription for a controlled substance by means of the internet (which includes telehealth technologies) without having first conducted at least one in-person medical evaluation, except in certain specified circumstances.  A public health emergency is one such exception to the in-person medical examination requirement.
Continue Reading Telehealth and Online Prescribing: COVID-19 Triggers Changes to the Prescriber/Patient/Pharmacist Relationship

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

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

CMS issued guidance this afternoon on expanded Medicare coverage of telehealth services during the COVID-19 outbreak. Under the guidance, Medicare will pay for office, hospital, and other visits furnished via telehealth across the country, including in patient’s places of residence, retroactive to March 6, 2020. CMS does not plan to enforce any requirement that visits be provided by physicians or practitioners with an established relationship with the patient. Telehealth visits will be paid at the same rate as regular, in person visits.  Read CMS’ fact sheet on waiver of telehealth requirements. CMS has also published a FAQ on the waiver, available here.

Coronavirus; Telehealth
Continue Reading Dateline: Telehealth and COVID-19

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