Health Law Advisor

Our colleague Steven M. Swirsky at Epstein Becker Green has recently published a post on the Management Memo blog that will be of interest to our readers in the health care industry: “NLRB Reverses Position on Confidentiality Concerning Workplace Investigations – Holds That Confidentiality Requirements Are Presumptively Lawful.”

Following is an excerpt:

The National Labor Relations Board, in its December 17^th decision in Apogee Retail LLC d/b/a Unique Thrift Store, has reversed its prior rule and held that employer requirements that employees treat ...

With 2019 nearly rolled up, it is time to exhale and recap the latest dose of marijuana laws affecting the workplace.  In the last twelve months, Illinois became the eleventh state to legalize recreational marijuana use by adults[1] and several other jurisdictions passed or modified their existing laws governing marijuana and the workplace.  Below is a summary of this year’s developments and some thoughts about what 2020 might bring.

Illinois Legalizes Recreational Marijuana Use

On June 25, 2019, Governor Pritzker signed the Illinois’ Cannabis Regulation and Tax Act into law ...

Our colleague Steven M. Swirsky at Epstein Becker Green has recently published a post on the Management Memo blog that will be of interest to our readers in the health employment and labor services industry: “NLRB Issues Proposed Rule to Scale Back 2014 Expedited Election Rules.”

Following is an excerpt:

The National Labor Relations Board (“Board” or “NLRB”) has announced that it is publishing proposed changes to its Rules and Regulations that will begin to reverse the Board’s 2014 changes, which took effect in 2015, to its representation election ...

Our colleague Sharon L. Lippett at Epstein Becker Green has recently published a post on the Financial Services and Employment Law blog that will be of interest to our readers in the health employment and labor services industry: “Monitoring ERISA Investment Fiduciaries.”

Following is an excerpt:

Fiduciaries of employee benefit plans subject to the Employee Retirement Income Security Act of 1974, as amended (“ERISA”) that appoint investment managers (“Appointing Fiduciaries”) will be interested in the opinion of the U.S. District Court for the Western ...

Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under Which Homeopathic Drugs May Be Marketed, and, concurrently, published revised draft guidance titled Drug Products Labeled as Homeopathic (the “Revised Homeopathic Draft Guidance”).

Homeopathy—an alternative medical approach that began in the late 18^th century—is based on the belief that (1) a substance that causes symptoms in a healthy ...

Today, a final rule issued by the Centers for Medicare & Medicaid Services (CMS) establishing new enforcement initiatives aimed at removing and excluding previously sanctioned entities from Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP) goes into effect.[1] Published September 10 with a comment period that also closed today, the new rule expands CMS’s “program integrity enhancement” capabilities by introducing new revocation and denial authorities and increasing reapplication and enrollment bars as part of the Trump Administration’s efforts to reduce spending. While CMS suggests that only “bad actors” will face additional burdens from the regulation, the new policies will have significant impacts on all providers and suppliers participating in Medicare, Medicaid, and CHIP.[2]

AN OVERVIEW OF THE NEW RULE

The New “Affiliations” Revocation Authority

The new “affiliations” enforcement framework—the regulation’s most significant expansion of CMS’s revocation authority—permits CMS to revoke or deny a provider’s or supplier’s enrollment in Medicare if CMS determines an “affiliation” with a problematic entity presents undue risk of fraud, waste, or abuse. Generally to bill Medicare, providers and suppliers not only must submit an enrollment application to CMS for initial enrollment, but also must recertify enrollment, reactivate enrollment, change ownership, and to change certain information.[3] In the rule’s current form, providers or suppliers submitting an enrollment application or recertification to CMS (“applicants”) will be required to submit affiliation disclosures upon CMS’s request if the agency determines the entity likely has an affiliation with a problematic entity as described below.[4] CMS will base its request on a review of various data, including Medicare Provider Enrollment, Chain, and Ownership System data and other CMS and external databases that might indicate problematic behavior, such as patterns of improper billing.[5] Upon CMS’s request, applicants identified as having at least one affiliation with a problematic entity would be required to report any current or previous direct or indirect “affiliations” to CMS.[6]

On October 22, 2019, the Centers for Medicare and Medicaid Services (“CMS”) issued a Request for Information (“RFI”) to obtain input on how CMS can utilize Artificial Intelligence (“AI”) and other new technologies to improve its operations.  CMS’ objectives to leverage AI chiefly include identifying and preventing fraud, waste, and abuse.  The RFI specifically states CMS’ aim “to ensure proper claims payment, reduce provider burden, and overall, conduct program integrity activities in a more efficient manner.”  The RFI follows last month’s White House ...

Our colleagues Amy F. Lerman, Francesca R. Ozinal, and team have released the 2019 update to Epstein Becker Green’s Telemental Health Laws survey.

Available as a complimentary app for iPhone, iPad, and Android devices, the survey covers state telehealth laws, regulations, and policies within mental health.

For more about the survey findings, visit “Epstein Becker Green Finds Telehealth Services Are Increasingly Accessible to Mental Health Professionals Despite Legislative Barriers.”

Also see the "Telemental Health Laws: Overview" for more about the ...

Continuing New Jersey’s efforts to eliminate and to hold employers accountable for employee misclassification, the state’s Department of Labor and Workforce Development (NJDOL) recently adopted Regulations implementing a 2010 law (“Law”) that empowers the NJDOL Commissioner (“Commissioner”) under certain circumstances to direct the suspension or revocation of one or more licenses held by an employer who has failed to maintain and report required State wage, benefits and tax records or who has failed to pay wages, benefits, taxes or other contributions ...

The Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services Office of Inspector General (OIG) issued their long-awaited proposed rules in connection with the Regulatory Sprint to Coordinated Care today.  Transforming our healthcare system to one that pays for value is one of the Department’s top four priorities, and the Deputy Secretary launched the Regulatory Sprint to remove potential regulatory barriers to care coordination and value-based care.

OIG’s proposed rule revising the safe harbors under the anti-kickback statute ...