We’ve been talking about telehealth and mental health this week. Here’s both combined in one interesting and highly valued announcement today, followed by several tests – well, 3 million COVID tests a week to be exact, and, speaking of Exact Sciences, developments in the early detection tests for the other major disease that is most feared, cancer.
Continue Reading Day 3 Notes for the 39th Annual J.P. Morgan Healthcare Conference, 2021

It’s Day 2 of the J.P. Morgan Annual Healthcare Conference at its finest – looking closely at healthcare inequities, strategic business shifts and killer robots, all in the same day! (Yes, we did say killer robots and it’s your reward for reading all the way to the end of this article).
Continue Reading Day 2 Notes for the 39th Annual J.P. Morgan Healthcare Conference, 2021

In our December 7, 2020 Blog Post, “Permanent Expansion of Medicare Telehealth Services,” we discussed the 2021 Medicare Physician Fee Schedule Final Rule (the “Final Rule”) and the regulatory changes made therein by the Centers for Medicare and Medicaid Services (“CMS”) to expand Medicare telehealth coverage within the confines of existing Medicare statutory law.  The Final Rule was first posted on December 2, 2020 and was formally published in the Federal Register on December 28, 2020.
Continue Reading The Permanency for Audio-Only Telehealth Act: A Matter of Healthcare Equity?

On December 1, 2020, the Centers for Medicare and Medicaid Services (“CMS”) released the annual Physician Fee Schedule final rule (“Final Rule”) which, among other things, aimed to further President Trump’s October 3, 2019 Executive Order #13890 on “Protecting and Improving Medicare for Our Nation’s Seniors” (the “EO”) by expanding the use of proven alternatives like telehealth services to Medicare beneficiaries even after the conclusion of the COVID-19 Public Health Emergency (the “Pandemic”).
Continue Reading Permanent Expansion of Medicare Telehealth Services

On September 3, 2020, the Department of Health and Human Services (HHS) released its Rural Action Plan (the “Plan”). The Plan: (i) details the challenges rural communities endure; (ii) provides an assessment of current and upcoming rural healthcare efforts; (iii) lays out a “Four Point Strategy” to address the disparities between rural and urban communities; and (iv) lays out an action plan featuring 71 action items for remediating the disparities consistent with the Four Point Strategy.

Continue Reading HHS Releases Rural Action Plan

On June 25, 2020, the Centers for Medicare & Medicaid Services (“CMS”) announced its proposed Home Health Prospective Payment System Rule, for calendar year 2021 (the “Rule”), which aims to increase home health agency Medicare payment rates.  This Rule also includes a provision to make permanent the regulatory changes related to telecommunication technologies in providing care under the Medicare home health benefit beyond the expiration of the COVID-19 public health emergency (“PHE”), which is set to time out at the end of July 2020.
Continue Reading CMS Issues Proposed Home Health Agency Rule On Making Certain Telehealth Flexibilities Permanent, Increasing Medicare Payment Rates And Home Infusion Therapy Service Payment Rates For CY 2021

Last week, new legislation was introduced in the U.S. House of Representatives that would require Medicare to reimburse certain telehealth services post the public health emergency period.  If passed, the bipartisan  Helping Ensure Access to Local TeleHealth Act of 2020 or HEALTH Act of 2020 (the “HEALTH Act of 2020”) would codify Medicare reimbursement and allow reimbursement for telehealth services provided by federally qualified health centers (“FQHCs”) and rural health clinics (“RHCs”).
Continue Reading Introducing the HEALTH ACT: Expanding Medicare Reimbursement

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

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

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 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