Amy Jeon McCullough

Amy McCullough represents a range of healthcare providers, including health systems, physician practices, and healthcare technology clients, among others. Her ability to effectively and efficiently navigate the complex healthcare regulatory landscape allows her to provide legal counsel to healthcare providers on federal and state healthcare statutory and regulatory issues, including, Federal and state fraud and abuse laws including the Stark Law, Anti-Kickback Statute, and False Claims Act; corporate practice of medicine and fee splitting; HIPAA and state privacy and security laws; Medicare and Medicaid compliance; reimbursement and billing, including alternative payment models; and telehealth.

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CMS Issues Additional Waivers and Guidance on Telehealth

To ensure Medicare beneficiaries have access to necessary care without risking exposure to COVID-19, the Centers for Medicare & Medicaid Services (CMS) has further expanded telehealth services and relaxed certain requirements related to the same with the issuance of additional waivers (available here) and an interim final rule (IFR) available here. … Continue Reading

California Telehealth Updates

By Amy Jeon McCullough and Danielle C. Gordet on April 9, 2020 Posted in Government Affairs, Licensure & Regulatory, Healthcare Law, HIPAA, Privacy, and Data Security, Hospitals & Health Systems, Medicare & Medicaid, Pharmacy, Drugs, Medical Devices & Equipment

California has joined the growing ranks of states, as well as the federal government, in efforts to facilitate the efficient provision of healthcare services during the pandemic. Accordingly, in response to federal agency updates with respect to relaxations to existing requirements related to telehealth services, California’s Governor Gavin Newsom issued an Executive Order No. 43-20 on April 3, 2020 (the … Continue Reading

North Carolina Telehealth Updates

By Amy Jeon McCullough, Sidney S. Welch and Danielle C. Gordet on April 1, 2020 Posted in Government Affairs, Licensure & Regulatory, Healthcare Law, Hospitals & Health Systems, Medicare & Medicaid, Pharmacy, Drugs, Medical Devices & Equipment

North Carolina has drastically expanded its telehealth services during the COVID-19 pandemic in order to give individuals increased access to remote care. The following article outlines many of the important changes implemented.

Licensure

On March 10, 2020, Governor Roy Cooper issued Executive Order No. 116 (available here) waiving the requirement that healthcare and behavioral healthcare personnel be licensed in … Continue Reading

Texas Telemedicine Updates

By Sidney S. Welch and Amy Jeon McCullough on March 27, 2020 Posted in Government Affairs, Licensure & Regulatory, Healthcare Law, Hospitals & Health Systems, Medicare & Medicaid, Pharmacy, Drugs, Medical Devices & Equipment

As with other states, in response to the COVID-19 pandemic and the guidance that the federal government has issued (see here), Governor Abbott of Texas issued a disaster declaration on March 13, 2020 (the Disaster Declaration) resulting in the loosening of certain existing telemedicine and telehealth related requirements in Texas.

Licensure.

For current license holders, the Texas … Continue Reading

Florida Telehealth Updates

By Danielle C. Gordet, Sidney S. Welch and Amy Jeon McCullough on March 25, 2020 Posted in Government Affairs, Licensure & Regulatory, Healthcare Law, Hospitals & Health Systems, Medicare & Medicaid, Pharmacy, Drugs, Medical Devices & Equipment

In response to the public health emergency declared in Florida on March 1, 2020, Florida loosened existing licensure and other telehealth requirements in response to the COVID-19 pandemic, as outlined below.

However, unless specifically waived or relaxed by the Orders (as defined below), all current minimum practice requirements and standards of care for telehealth services set forth under F.S.A. §456.47 … Continue Reading

Illinois Telehealth Updates

By Amy Jeon McCullough and Sidney S. Welch on March 24, 2020 Posted in Government Affairs, Licensure & Regulatory, Healthcare Law, Hospitals & Health Systems, Medicare & Medicaid, Pharmacy, Drugs, Medical Devices & Equipment

Like many other states, in response to the COVID-19 pandemic and the guidance that the federal government has issued, Governor Pritzker of Illinois issued an executive order (2020-09) on March 19, 2020, amending and relaxing existing telehealth related requirements under 225 ILCS 60/49.5 regarding: (1) telemedicine services provided by licensed Illinois physicians; (2) telemedicine and telepsychiatry services provided to Illinois … Continue Reading

Breaking Developments for Telehealth and Teleprescribing in Georgia

By Amy Jeon McCullough and Sidney S. Welch on March 23, 2020 Posted in Government Affairs, Licensure & Regulatory, Healthcare Law, Hospitals & Health Systems, Medicare & Medicaid, Pharmacy, Drugs, Medical Devices & Equipment, Technology

Unsurprisingly, COVID-19 has created a great degree of liberalization in the telehealth requirements previously in place. What has not changed is the fact that telehealth services are governed by a number of different laws and regulations, all of which are constantly changing – now more than ever. In addition to the multiple changes at the federal level, what follows is … Continue Reading

OCR Fee Limits for Third Party Directive Record Requests Struck Down

By Amy Jeon McCullough on February 4, 2020 Posted in Electronic Health Records & Medical Records, Healthcare Law, HIPAA, Privacy, and Data Security

On January 28, 2020, the U.S. Department of Health & Human Services Office for Civil Rights (OCR) issued a notice (the OCR Notice) regarding individuals’ right of access to health records in response to a January 23, 2020 court ruling in the Ciox Health, LLC v. Azar, et al., No. 18-cv-0040 (D.D.C. Jan. 23, 2020) case. OCR noted that … Continue Reading

Georgia Leads the Way with Enactment of Pharmacy Anti-Steering Law

By Amy Jeon McCullough on May 29, 2019 Posted in Fraud & Abuse & False Claims Act, Healthcare Law, Pharmacy, Drugs, Medical Devices & Equipment

With an overwhelming amount of bi-partisan support, on May 7, 2019, Georgia enacted the Pharmacy Anti-Steering and Transparency Act, O.C.G.A. §26-4-119 (the GA Act). The GA Act goes into effect as of January 1, 2020.

As healthcare providers are well aware, prohibitions against self-referrals are not new – federal and state laws prohibiting self-referrals by physicians and other healthcare … Continue Reading

Caution: Curb Your Enthusiasm for the Reduced HIPAA Annual Limits

By Amy Jeon McCullough on May 22, 2019 Posted in Healthcare Law, HIPAA, Privacy, and Data Security

Until recently, the annual limit for civil monetary penalties (CMP) that could be levied against covered entities and business associates in violation of the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations, as amended from time to time (collectively, HIPAA) was $1,500,000. On … Continue Reading