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Tracey Toll

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Tracey focuses her practice on healthcare and regulatory compliance and works with a wide range of clients, including pharmacies, durable medical equipment suppliers, home health agencies, and hospitals. She advises clients on state and federal regulatory and compliance issues, transactional matters, licensure issues, and Medicare and Medicaid reimbursement procedures.

Electronic medical record with patient data and health care information in tablet. Doctor using digital smart device to read report online. Modern technology in hospital.

On December 10, 2020, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) released a proposed rule that would revise the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

In its news release, OCR noted that the changes “seeks to promote value-based health care by examining federal regulations that impede efforts among healthcare providers and health plans to better coordinate care for patients.”  The proposed changes come on the heels of the recently delayed Information Blocking Rule, which seeks to prohibit interferences with access, exchange, or use of electronic health information (EHI).   The key proposed changes are discussed below.

Hospice Insights

With all that 2020 has brought, the Information Blocking Rule that came out of the Cures Act was under the radar of many hospices. Thankfully, HHS extended the compliance date for the Rule to April 5, 2021, from November 2, 2020. With this additional time, hospices need to evaluate how they will achieve compliance; what…

Telehealth

On May 1, 2020, the Department of Health and Human Services, Office of the National Coordinator for Health Information Technology (ONC) released its final rule (Final Rule) on “Information Blocking” as part of the 21st Century Cures Act. The Final Rule applies to the following (ONC refers to each one as an “Actor”): (i) healthcare providers, (ii) health IT developers subject to ONC’s Health IT Certification Program, (iii) health information networks (HIN) or (iv) health information exchanges (HIE). With the initial enforcement date fast approaching (November 2), we explain the rule below.

Economic Hardship Covid19

On October 1, 2020 the Department of Health and Human Services (“HHS”) announced that it will distribute a total of $20 billion as part of Phase 3 of the Provider Relief Funds. The application for Phase 3 funding is now open and will be available from October 5 – November 6, 2020. However, HHS has urged providers to apply early, which may be an indication that the funds will be available on a first-come first-serve basis.

Below are some key details regarding Phase 3:

Laboratory Testing

On August 4, 2020, the Office of Inspector General for the United States Department of Health and Human Services (OIG) released an FAQ regarding whether a clinical laboratory may provide free antibody testing to federal health care program beneficiaries (e.g. Medicare/Medicaid beneficiaries). In its FAQ, the OIG acknowledged that providing such testing would implicate two federal anti-fraud statutes–the federal Anti-Kickback Statute (AKS) and the federal Civil Monetary Penalties Law (CMPL). However, so long as the laboratory implemented certain safeguards, the arrangement would pose a sufficiently low risk that OIG would not pursue an enforcement action.

PHI Covid19 population-based activities

On June 12, 2020, the U.S. Department of Health and Human Services, Office for Civil Rights (OCR), issued guidance confirming HIPAA permits a covered healthcare provider (Provider) to use protected health information (PHI) to identify and contact recovered COVID-19 patients to inform them of how they can donate their blood and plasma.  As background, HIPAA…