Health Law Advisor

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 ...

In September 2019, the New Jersey Division of Rights (“DCR”) issued enforcement guidance (“Guidance”) clarifying and explaining how the DCR applies the state’s Law Against Discrimination (“LAD”) to discrimination based on hairstyles, particularly with respect to those “closely associated with Black people.”  The Guidance states that the LAD’s prohibition on discrimination based on race encompasses discrimination that is ostensibly based on hairstyles that are inextricably intertwined with or closely associated with race and therefore prohibits ...

Earlier this month, the FDA released programmatic guidance intended to clarify the current review practices for the Humanitarian Device Exemption (“HDE”) Program (“Guidance”) reflecting recent changes in the HDE Program resulting from statutory amendments made by the 21^st Century Cures. The Guidance addresses frequently asked questions about FDA actions on HDE applications, post-approval requirements, and includes a filing checklist to clarify the required information for the FDA to consider whether an HDE application is ready for substantive review.

Unlike ...

Based on findings of the Payment Accuracy Report recently issued by the Department of Health and Human Services (DHHS), six Democratic United States Senators questioned the Centers of Medicare and Medicaid Services’ (CMS) oversight and enforcement of Medicare Advantage (MA) plans. In a letter dated September 13, 2019, the Senators highlighted their belief that MA plans have been overbilling the federal government for years, specifically in excess of $30 billion dollars over the last three years.

The Senators requested that CMS provide a response on how the Agency intends to ...

Interoperability and patient access to data has been pushed to the forefront as a primary concern for the health industry. This is largely due to proposed rules published this spring by the Office of the National Coordinator for Health Information Technology (ONC) and the Center for Medicare and Medicaid Services (CMS) that seek to advance interoperability and support the access, exchange, and use of electronic health information. In August 2019, the ONC held its third annual National Coordinator for Health IT Interoperability Forum in Washington DC. The event brings together the ...

On September 10, 2019, the Office of Inspector General of the Department of Health and Human Services (“OIG”) published Advisory Opinion 19-04.  In this favorable opinion, OIG approved a technology company’s proposal to make its online healthcare directory search results visible to federal healthcare beneficiaries in locations where the company charges the healthcare professionals a per-click or per-booking fee to be included in the directory.  It also approved the company’s proposal to make sponsored advertisements that appear on its online healthcare directory and ...

In an effort to address the challenge of increasing drug prices for patients and families, the U.S. Food and Drug Administration (“FDA”) and the U.S. Department of Health and Human Services (“HHS”) recently outlined a proposal for facilitating the importation of pharmaceuticals originally intended for foreign markets.  The Safe Importation Action Plan (the “Action Plan”), jointly announced on July 31, 2019, describes two different potential pathways for importing certain drugs. The Action Plan offers only a limited overview of the proposed pathways and does not ...

As discussed in our March 28, 2019 blog post, New Jersey adopted its own individual health insurance mandate, the   New Jersey Health Insurance Market Preservation Act (“NJHIMPA”).  The NJHIMPA requires, with certain qualifying exemptions, New Jersey residents to have minimum essential health coverage. New Jersey employers must verify health coverage information provided by individuals. To assist with employer reporting, New Jersey launched an official website with guidance on the filing requirements.

Recent updates to the official website, which was lasted updated on ...

Following an effort in the state legislature to legalize recreational marijuana, on July 29, 2019, Governor Andrew Cuomo signed S.6579A/A.8420 (the “Law”), a law decriminalizing marijuana possession in New York State. The Law will take effect on August 28, 2019. The Law expunges many past convictions for marijuana use and reduces the penalty for possession of small amounts (less than two ounces) of the drug from a misdemeanor to a violation.

Importantly, the Law does not legalize marijuana, and – relevant to this blog – therefore provides no employment protections for ...

Federal lawmakers are debating legislation to address surprise medical bills that, if passed in its current form, would significantly impact how hospitals, physicians and insurers negotiate payment for the provision of certain out-of-network services. A bipartisan coalition led by Senator Lamar Alexander (R-Tennessee), Chairman of the Senate Health, Education, Labor and Pension Committee, and Senator Patty Murray (D-Washington) aims to present to the President for signature a bill to curb surprise billing practices by the end of the year.

Instances of surprise medical ...