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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 Thursday, April 16, 2020, the California Department of Managed Health Care (the “Department”) released an all plan letter (the “Letter”) regarding changes to the Department’s General Licensure Regulation (the “Regulation”) in light of the coronavirus (COVID-19) pandemic.  The Letter updated the Department’s previous guidance concerning the Regulation that was issued on June 13, 2019.  For further information, see our previous post regarding the Regulation here.  
Continue Reading The California Department of Managed Health Care Extends the Phase-In Period for the General Licensure Regulation

On April 23, 2020, the Kaiser Family Foundation (“KFF”) issued a report authored by Priya Chidambaram entitled, “State Reporting of Cases and Deaths Due to COVID-19 in Long-Term Care Facilities.” In the KFF report, Ms. Chidambaram cited to previous KFF studies showing that COVID-19 has had a disproportionate impact on people who reside or work in long-term care facilities – such populations including 1.3 million nursing home residents, 800,000 assisted living facility residents, 75,000 intermediate care facility residents, and 3 million people who work in skilled nursing or residential care facilities.
Continue Reading Data Reporting, Patient Access and Malpractice Liability: Nursing Homes and Long-Term Care Facilities Command Federal and State Attention during the COVID-19 Public Health Emergency

The unprecedented impact of COVID-19 has created a myriad of challenges for healthcare providers to safely meet the evolving needs of their patients solely through a traditional in-person model. Telehealth has quickly shifted from a “nice-to-have” strategy to an essential tool for all healthcare organizations.
Continue Reading Sheppard Mullin and Citrin Cooperman Rollout Telehealth Maturity Model

On April 16, 2020, the Trump Administration issued its “Opening Up America Again Guidelines” (the “OUAA Guidelines”) as a self-styled roadmap to the staged reopening of the American economy.

On Sunday, April 19, 2020, the Centers for Medicare & Medicaid Services (“CMS”) followed suit by issuing new guidance (the “Reopening Guidance”) designed to reintroduce the provision of non-essential surgeries and medical procedures by healthcare providers located in “Phase 1” states and/or regions.  Such non-elective procedures were previously put on hold at the state and local levels in accordance with prior CMS guidance dated March 18, 2020 (the “March Guidance”) in which CMS called for the delay of all elective surgeries, non-essential medical, surgical, and dental procedures during the COVID-19 state of emergency.
Continue Reading Elective and Non-Essential Medical Procedures: States React to Federal Recommendations and the Opening Up America Again Guidelines

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 Wednesday, April 9, 2020, the Centers for Medicare and Medicaid Services (“CMS”) hosted a call entitled “COVID-19 with Nursing Homes.” CMS leadership aimed to provide updates on the agency’s latest guidance, joined by leaders in the field interested in sharing best practices with their peers.
Continue Reading CMS Addresses Nursing Home and Long-Term Care Providers Amidst COVID-19 Pandemic: Best Practices and What’s to Come

On Tuesday, April 7, 2020, the California Department of Managed Health Care (the “DMHC”) released a guidance letter (the “Letter”) to all health care service plans regarding billing for and delivering telehealth services during the COVID-19 state of emergency.  The Letter provides  follow-up guidance to previous guidance the DMHC released on Wednesday, March 18, 2020 (the “Initial Guidance”).  The DMHC has also provided additional information regarding the most frequently asked telehealth questions it has received (the “FAQs”).
Continue Reading California Department of Managed Health Care Releases Additional Guidance on Telehealth Services

On April 2, 2020, the Office for Civil Rights at the U.S. Department of Health and Human Services (“HHS”) announced a Notification of Enforcement Discretion to allow certain uses and disclosures of Protected Health Information (“PHI”) by HIPAA business associates during the COVID-19 public health emergency.  Understanding that the CDC, CMS and state and local health departments need quick access to COVID-19 related healthcare data in order to fight the pandemic, HHS decided to grant HIPAA business associates greater freedom to cooperate and exchange COVID-19-related information with public health and oversight agencies.
Continue Reading HHS Further Relaxes HIPAA Regulations Governing Use and Disclosure of Protected Health Information During the COVID-19 Public Health Emergency