North America

PRRB Updates Its Rules and Mandates Electronic Filing

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 submits a request to the Board for an exemption and the Board grants that request. If an exemption is necessary, a provider or representative may communicate with the Board at a new email address (PRRB@cms.hhs.gov).   In order to file documents electronically, providers or their representatives should register with OH-CDMS in advance of any filing date.

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Federal contractor vaccine mandates: Preparing for compliance

President Joe Biden’s September 9, 2021 COVID-19 Action Plan laid out a broad strategy to get more people vaccinated. A key piece of that strategy is the Executive Order for Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors (“order”) that requires employees of federal government contractors to be vaccinated, unless they fall within an approved exemption. Consistent with the president’s approach, the Safer Federal Workforce Task Force issued COVID19 Workplace Safety: Guidance for Federal Contractors and Subcontractors (“guidance”) on September 24 that spell out the steps of complying with the Order. Read more…

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Podcast: No Surprises Act: Considerations for Plans and Providers – Diagnosing Health Care

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.

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Charitable Health Systems and Other Owners of Tax-Exempt Property with Operations in Ohio Should Prepare for Upcoming Changes to Real Property Tax Exemption Laws

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 codified at section 5713.083 of the Ohio Revised Code.  The change will require those who own real estate that is exempt from property tax to notify the county auditor by December 31 of the year in which the property ceases to qualify for exemption.

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Federal contractors have new guidance and December 8 deadline for vaccine mandates

On September 24, 2021, the U.S. Safer Federal Workforce Task Force released new guidance on compliance with President Joe Biden’s Executive Order 14042 “Ensuring Adequate Safety Protocols For Federal Contractors,” which mandates COVID-19 safety protocols that all federal prime contractors and subcontractors must follow. Read more…

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CMS Proposes to Reverse Course and Repeal Its Final Rule Expediting Medicare Coverage of Breakthrough Devices and Defining the Medicare “Reasonable and Necessary” Coverage Standard

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.

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Planning for the COVID-19 ETS: Vaccine mandates, regular testing, and more

President Joe Biden announced the COVID-19 Action Plan, which included broad-ranging initiatives designed to provide a path out of the pandemic, on September 9.  The plan included an element most employers had not expected:  Employers with 100 or more employees must mandate vaccines or require weekly COVID-19 testing of unvaccinated employees.  Read more…

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Unpacking Averages: FDA Review Time for 510(k)s

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.

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Navigating New Jersey’s Telemedicine Business Registry

The New Jersey Department of Health (the “Department”) recently finalized regulations initially proposed in April 2020 that will now require all telehealth organizations providing telemedicine services to patients located in New Jersey to register their business with the Department before October 15, 2021, and annually thereafter.  In addition to annual registrations, telehealth companies will also be required to submit annual reports on activity and encounter data.

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Mandatory Vaccinations Are Coming for Many Employees Nationwide

On September 9, 2021, President Biden announced that his Administration is implementing a six-pronged, comprehensive national strategy to ensure that all available tools are being used to combat COVID-19.  The plan addresses: (1) vaccinating the unvaccinated; (2) further protecting the vaccinated; (3) keeping schools safely open; (4) increasing testing and requiring masking; (5) protecting the economic recovery; and (6) improving care for those with COVID-19.  The first strategy is germane to employers.

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