Health Law Advisor

[UPDATE, Nov. 30, 2021: The District Court for the Eastern District of Missouri grants injunction for the ten plaintiff states listed in the First Complaint.]

As we previously reported, effective November 5, 2021, the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule (the Rule) requiring full COVID-19 vaccination for staff and others at Medicare- and Medicaid-certified providers and suppliers as a Condition of Participation by January 4, 2022.

On November 10, 2021, a coalition of ten states lodged a complaint in the U.S. District Court for the Eastern ...

Interest in, and acceptance of, telehealth services continues to grow. Federal and state legislators are under pressure to codify the flexibilities granted in response to the COVID-19 pandemic that increased access to telehealth services. Meanwhile, increased use of telehealth has put a much greater focus on the potential for fraudulent behavior and increased enforcement activity as a result. Telehealth providers should continue to monitor developments in federal and state laws, regulations, and policies to capitalize on telehealth opportunities while at the same time ...

As featured on the Diagnosing Health Care Podcast:  As 2021 nears a close, acute care hospitals and health systems are facing a host of financial, regulatory, and legislative challenges. In this special episode of Diagnosing Health Care, Rick Pollack, President and CEO of the American Hospital Association, and Epstein Becker Green’s Ted Kennedy, Jr., discuss the ways in which the industry is working with the Biden administration and Congress to shape policy around critical issues, such as surprise billing, coverage expansion, value-based care, and telehealth.

Rick ...

While this column typically uses data visualizations you’ve probably seen before, I want to introduce one that perhaps you have not.  This is in the realm of text analysis.  When looking at FDA data, there are numerous places where the most interesting information is not in a data field that can be easily quantified, but rather in narrative text.  Take, for example, Medical Device Reports of adverse events, or “MDRs.”  While we can do statistical analysis of MDRs showing, for example, which product categories have the most, the really interesting information is in the descriptions ...

The Federal Trade Commission (“FTC”) recently issued guidance clarifying protections applicable to consumers’ sensitive personal data increasingly collected by so-called “health apps.” The FTC press release indicated it has approved a policy statement by a vote of 3-2 offering guidance that organizations using “health applications and connected devices” to “collect or use” consumers’ personal health information must comply with the cybersecurity, privacy and notification mandates of the Health Breach Notification Rule (the “Rule”).

The ...

On September 30, 2021, the Provider Reimbursement Review Board (the “Board”) issued a revised set of rules that become effective November 1, 2021. These new and revised rules affect all new and some pending Medicare Part A provider appeals. These rules clarify several aspects of Board appeals and simplify some of the Board’s complex procedures.

The most significant change is the requirement that all submissions to the Board must be made electronically through the Office of Hearings Case and Document Management System (“OH-CDMS”) unless the provider or representative ...

In this column, in the coming months we are going to dig into the data regarding FDA regulation of medical products, deeper than the averages that FDA publishes in connection with its user fee obligations.  For many averages, there’s a high degree of variability, and it’s important for industry to have a deeper understanding.  In each case, we will offer a few preliminary observations on the data, but we would encourage a conversation around what others see in the data.

Chart

This is an interactive chart that you can explore by clicking on the colors in the legend to see how specific ...

In this episode of the Diagnosing Health Care Podcast:  On December 27, 2020, President Trump signed into law the No Surprises Act as part of the $2.3 billion Consolidated Appropriations Act. Recently, the Biden administration issued its first interim final rule in order to implement this act, which will go into effect on January 1, 2022. While the goal is to protect patients from surprise billing, the law will also impose significant compliance burdens on plans, providers, and facilities.

Epstein Becker Green attorneys Helaine Fingold, Bob Hearn, and Alexis ...

Starting in 2022, Ohio will require owners of tax-exempt real property to notify the county auditor if the exempt property ceases to qualify for exemption.

This is a substantial departure from current law, which had left the role of monitoring changes in exempt properties’ uses to the county auditors or Ohio’s tax commissioner; under the new law, health care entities that own property in the state must determine whether or not their property continues to qualify for exemption.

Ohio’s recent Budget Bill – House Bill 110 – created the new reporting requirement, which will be ...

On September 15, 2021, CMS published a proposed rule that would repeal a final rule that created an expedited pathway for Medicare coverage of breakthrough devices and established formal criteria for applying the “reasonable and necessary” standard for coverage in Section 1862(a)(1)(A) of the Social Security Act, which has been the basic standard for coverage since the inception of the Medicare program.[1]  CMS has set a short period for comments, and interested parties must submit comments by October 15, 2021.

The new proposed rule reflects a significant policy change.  Where the initial rule focused on expanding access to new innovations, the current approach focuses more on Medicare program goals and outcomes data.