Health Law Advisor

Reversing its prior position, CMS announced on December 28, 2021, that it would begin enforcement of the COVID-19 vaccine requirement, established by the interim final rule, published November 05, 2021, in 25 states and the District of Columbia[1] in a phased approach beginning January 27, 2022. With the announcement CMS issued guidance for surveyors regarding enforcement in S&C Memo QSO 22-07-ALL (“Memo”), describing how CMS will enforce the rule and how facilities that are non-compliant may avoid enforcement action if meeting certain threshold criteria during periods up to 90 days after issuance of the Memo as follows:

On the evening of Wednesday, December 22, 2021, the Supreme Court of the United States announced that it will hold a special session on January 7, 2022, to hear oral argument in cases concerning whether two Biden administration vaccine mandates should be stayed. One is an interim final rule promulgated by the Centers for Medicare and Medicaid Services (“CMS”); the other is an Emergency Temporary Standard (“ETS”) issued by the U.S. Department of Labor’s Occupational Safety and Health Administration (“OSHA”). The CMS interim final rule, presently stayed in 24 states, would require COVID-19 vaccination for staff employed at Medicare and Medicaid certified providers and suppliers. The OSHA ETS, which requires businesses with 100 or more employees to ensure that workers are vaccinated against the coronavirus or otherwise to undergo weekly COVID-19 testing, was allowed to take effect when a divided panel of the United States Court of Appeals for the Sixth Circuit, to which the consolidated challenges had been assigned by the Judicial Panel on Multidistrict Litigation issued a ruling, on December 17, 2021, lifting a stay that had been previously entered by the Fifth Circuit. Multiple private sector litigants and states immediately challenged the decision.

Recent data thefts and systems intrusions, particularly with respect to ransomware, have assured that cybersecurity is top of mind for corporate executives and compliance officials. We at EBG have tried to keep you up to date with respect to legislative, regulatory and litigation developments and recommended best practices and procedures.

As we close out the year, we all should remain mindful that cyber criminals, especially those who are supported or protected by foreign adversaries, have little incentive to rest up during the holidays.

As we previously reported, the Centers for Medicare & Medicaid Services' (CMS's) interim final rule (the “Rule”) requiring full COVID-19 vaccination for staff and others at Medicare- and Medicaid-certified providers and suppliers (i.e., the “vaccine mandate”) was effectively stayed nationwide on November 30, 2021, by the U.S. District Court for the Western District of Louisiana (the “Louisiana Court”).  In yet another twist to the ongoing legal battles, the U.S. Court of Appeals for the Fifth Circuit lifted the nationwide stay and held that the Louisiana Court only had authority to block the vaccine mandate in the fourteen plaintiff states that brought suit in that court. Those states are Alabama, Arizona, Georgia, Idaho, Indiana, Kentucky, Louisiana, Mississippi, Montana, Ohio, Oklahoma, South Carolina, Utah, and West Virginia.

Due to the litigation in the Eastern District of Missouri, as reported here, enforcement of the vaccine mandate is also blocked in ten other states:  Alaska, Arkansas, Kansas, Iowa, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota and Wyoming.  In total, the vaccine mandate under the Rule is now stayed in twenty-four states, but is now in effect in the remaining twenty-six states.

Important guidance regarding COVID-19 testing in the workplace was recently issued by the Centers for Medicare & Medicaid Services (“CMS”) in the form of Frequently Asked Questions regarding Over the Counter (“OTC”) Home Testing and CLIA Applicability.

CMS regulates clinical laboratory testing pursuant to the federal Clinical Laboratory Improvement Act (“CLIA”). Generally, a laboratory or clinical setting (such as a physician’s office) must obtain CLIA certification to perform laboratory testing. Some OTC tests, however, are approved by the Food and Drug Administration (“FDA”) for home use and the new FAQs address the use of OTC home tests in the workplace.

On December 13, 2021, the Supreme Court of the United States rejected the petition of New York health care workers seeking to stop the State from enforcing regulations requiring covered personnel of hospitals, nursing homes, public health centers, and other health care entities to be fully vaccinated against COVID-19 as a condition of continued employment, subject to narrow exceptions. The Supreme Court’s unsigned order allows the continuing enforcement of the regulations, as litigation of the multiple lawsuits challenging the statewide vaccine mandate for health care workers issued last August continues.

In this episode of the Diagnosing Health Care Podcast:  The No Surprises Act (NSA) will go into effect on January 1, 2022. Since our last episode on the topic, the federal government has issued additional interim final rules and guidance to implement the NSA, including the second interim final rule. In addition to describing how the NSA interacts with the plan external review procedures, the second interim final rule describes the independent dispute resolution (IDR) process and how the IDR’s determination is made.

Attorneys Helaine Fingold, Lesley Yeung, and Alexis Boaz dive into how these changes impact entities subject to the NSA’s balance billing prohibitions.

As we previously reported, the Centers for Medicare and Medicaid Services’ (CMS) interim final rule (“the Rule”) requiring full COVID-19 vaccination for staff and others at Medicare- and Medicaid-certified providers and suppliers (i.e., the “vaccine mandate”) has been challenged in the U.S. District Courts for the Eastern District of Missouri (“the Missouri Court”) and the Western District of Louisiana, Monroe Division (“the Louisiana Court”).  As of the date of this writing, both Courts have granted preliminary injunctions placing the Rule on hold.

On November 29, 2021, the Missouri Court granted a preliminary injunction of the Rule, which applies to the coalition of ten states [1] that filed the challenge there. The following day, the Louisiana Court entered a similar injunction, which applies to the remaining forty states.

This month, we’re going to look at a visualization that uses network techniques. Visualizing a network is a matter of nodes and edges. If the network were Facebook, the nodes would be people, and the edges would be the relationships between those people. Instead of people, we are going to look at specific device functionalities as defined by the product codes. And instead of relationships, we are going to look at when device functionalities (i.e., product codes) are used together in a marketed device as evidenced by a 510(k) submission.

From our Thought Leaders in Health Law video series:  Is your organization ready for the No Surprises Act (NSA)? The law goes into effect January 1, 2022, and contains a new federal ban on surprise billing as well as new disclosure requirements.

The NSA applies to certain payors, providers, facilities, and ancillary service entities that support patients who receive emergency services or other non-emergency services at certain facilities, such as hospitals, hospital outpatient departments, and ambulatory surgical centers.