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Erica M. Ash

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Erica helps healthcare clients navigate regulatory matters so they can get back to the business of patient care. She assists clients with compliance, transactional and licensure matters, including Health Insurance Portability and Accountability Act (HIPAA) compliance, Medicare and Medicaid reimbursement procedures, Stark Law compliance, and fraud, waste and abuse issues.

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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.

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.

Background

 On Wednesday, April 8, 2020, the U.S. Department of Health & Human Services (HHS) Office of the Assistant Secretary for Health released guidance authorizing pharmacists to “order and administer COVID-19 tests, including serology tests, that the Food and Drug Administration (FDA) has authorized.”  In its guidance, HHS granted licensed pharmacists immunity when administering or ordering FDA-authorized COVID-19 tests and stated that they will be considered a “covered person” under the Public Readiness and  Preparedness Act (PREP Act) when taking such actions. The PREP Act confers immunity for covered persons, from claims arising out of state law. For more background information about the April 8, 2020 HHS guidance, see our previous post available here.

On April 14, 2020, CMS released a ruling that will increase the reimbursement for tests conducted to detect SARS–CoV–2 (the diagnosis of the virus that causes COVID–19) for tests utilizing “high throughput technologies.” The reimbursement under Medicare Part B for these laboratory tests will be raised from about $51 per test to $100 per test. This increase will begin with tests performed on or after March 18, 2020 and end when the national emergency is over.

On April 8, 2020, the U.S. Department of Health & Human Services (HHS) Office of the Assistant Secretary for Health released guidance authorizing pharmacists to order and administer COVID-19 tests.  Immediately following this guidance, on April 9, 2020, the HHS Office of Civil Rights (OCR) announced that it will exercise its enforcement discretion and will refrain from imposing penalties for violations of HIPAA for covered entities or business associates participating, in good faith, in the operation of COVID-19 Community-Based Testing Sites (CBTS) during the nationwide public health emergency.  The guidance regarding pharmacists testing for COVID-19 and the notice related to the relaxation of HIPAA rules comes on the heels of pharmacies, such as CVS and Walgreens, taking on a more active and critical role in the fight against the COVID-19 pandemic.

On Wednesday, April 8, 2020, the U.S. Department of Health & Human Services (HHS) Office of the Assistant Secretary for Health released guidance authorizing pharmacists to “order and administer COVID-19 tests, including serology tests, that the Food and Drug Administration (FDA) has authorized.”  HHS noted that it recognized that most Americans are relatively close to a retail pharmacy and they interact with pharmacists more frequently than other healthcare professionals. Allowing pharmacists to administer the tests should reduce travel to testing locations – an important mitigation step.  HHS Secretary Alex Azar issued the following statement:

On March 27, 2020, President Trump signed the Coronavirus Aid, Relief and Economic Security Act (the CARES Act) into law. Section 3221 of the CARES Act ratified fundamental changes to the Public Health Service Act, codified at 42 U.S.C. § 290dd-2 and associated regulations, which govern the confidentiality requirements of substance use disorder records, commonly known as 42 C.F.R. Part 2, or simply, “Part 2.” Substance use disorder (SUD) records are defined broadly as “[r]ecords of the identity, diagnosis, prognosis, or treatment of any patient which are maintained in connection with the performance of any program or activity relating to substance abuse education, prevention, training, treatment, rehabilitation, or research.” The changes are significant and align with the increasing movement to align the Part 2 rules with the Health Insurance Portability and Accountability Act (HIPAA). The CARES Act requires the Department of Health and Human Services (HHS) to revise the Part 2 regulations within 12 months to comply with the CARES Act.

On March 17, 2020, the Department of Health and Human Services, Office of Civil Rights (OCR) issued guidance related to how Covered Entities can comply with HIPAA and the Privacy Rule and still disclose protected health information (PHI) about individuals infected with or exposed to COVID-19 to law enforcement, paramedics, other first responders, and public health authorities (Essential Providers).

In this short recording, Healthcare attorneys Wakaba Tessier and Erica Ash discuss a recent Department of Justice (DOJ) settlement involving a specialty pharmacy and its private equity owner. This case is significant because – not only did the DOJ name the compounding pharmacy and its two executives – but it also named the private equity firm that owned

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