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New Program Integrity Rule Expanding Medicare Revocation and Denial Authorities Takes Effect Today

By George B. Breen, Melissa L. Jampol & Alexis Boaz

November 4, 2019

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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…

Health Law Advisor

CMS’s Request for Information Provides Additional Signal That AI Will Revolutionize Healthcare

By Alaap Shah & Audrey Davis

October 28, 2019

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…

Health Law Advisor

Telemental Health Laws Update: 2019 Survey and App Released

By Epstein Becker & Green, P.C.

October 21, 2019

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…

Health Law Advisor

Arrangements, Exceptions, and Modifications – OIG and CMS Challenge the Status Quo

By Anjali N.C. Downs, Jennifer Michael & Victoria Vaskov Sheridan

October 9, 2019

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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 …

Health Law Advisor

Federal Legislators Express Continued Concerns with Oversight of Medicare Advantage Plans

By Jason E. Christ, Helaine I. Fingold & Ashley Creech

September 25, 2019

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…

Health Law Advisor

FDA Guidance Clarifies HDE Program Review

By Elizabeth Scarola

September 25, 2019

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 21st 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…

Health Law Advisor

The FDA Looks Inward as It Tackles Interoperability

By Ebunola Aniyikaiye

September 13, 2019

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…

Health Law Advisor

OIG Approves Per-Click Fee Arrangement for Online Healthcare Directory

By Jennifer Michael

September 12, 2019

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…

Health Law Advisor

HHS and FDA Propose Action Plan for the Importation of Certain Foreign Drugs into the United States

By Jessika Tuazon

September 9, 2019

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…

Health Law Advisor

Congress Explores Surprise Medical Bill Legislation to Reduce Impact on Patients

By Helaine I. Fingold & Sidra S. Galvin

August 21, 2019

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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…

Health Law Advisor

Thought Leaders on Laws and Regulations Affecting Health Care and Life Sciences

Blog Authors

New Program Integrity Rule Expanding Medicare Revocation and Denial Authorities Takes Effect Today

CMS’s Request for Information Provides Additional Signal That AI Will Revolutionize Healthcare

Telemental Health Laws Update: 2019 Survey and App Released

Arrangements, Exceptions, and Modifications – OIG and CMS Challenge the Status Quo

Federal Legislators Express Continued Concerns with Oversight of Medicare Advantage Plans

FDA Guidance Clarifies HDE Program Review

The FDA Looks Inward as It Tackles Interoperability

OIG Approves Per-Click Fee Arrangement for Online Healthcare Directory

HHS and FDA Propose Action Plan for the Importation of Certain Foreign Drugs into the United States

Congress Explores Surprise Medical Bill Legislation to Reduce Impact on Patients

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