The Consolidated Appropriations Act, 2021, Public Law 116-260 (CAA) set forth new compensation disclosure requirements that apply to service providers who provide “brokerage services” or “consulting” to group health plans subject to the Employee Retirement Income Security Act of 1974
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Continuing Consolidation in Orthopedic Medicine
Physician consolidation continued on a robust pace this past year, despite, or maybe because of, the Pandemic. Physician-owned orthopedic practices appear to be no exception to this trend. Interestingly, orthopedic physicians, including spine physicians, are among the most independent of…
FDA Addresses the Role of Digital Health Technology in Clinical Trials
The U.S. Food & Drug Administration (FDA) recently issued draft guidance regarding the use of digital health technology (DHT) for the remote acquisition of clinical trial data.
DHT can take the form of hardware and software, and is capable of…
Medicare Telehealth and Substance Use Disorder Treatment FAQs: New CMS Reimbursement Requirements
In the 12-month period starting in April 2021, over 100,000 people have died from drug overdoses, a 28.5% increase from the same period the year before. While the opioid crisis has been a declared public health emergency (PHE) since October…
Four Key Takeaways for Digital Health Companies from the FTC’s Recent COPPA Settlement
True to its word, the Federal Trade Commission (FTC) has continued to focus on online privacy by targeting digital platforms that collect personal information. Most recently, the FTC has focused its enforcement authority on OpenX Technologies, Inc., a real-time…
New Jersey Allows Asynchronous Telemedicine
On December 21, 2021, New Jersey amended its telemedicine laws via SB 2559. The new changes expressly allow the use of asynchronous store-and-forward telemedicine as a standalone modality, remove prior prohibitions on audio-only modalities, and clarify what constitutes unacceptable…
FDA Drafts Public Health Emergency Transition Plan: What Device Manufacturers Need to Know
The U.S. Food & Drug Administration (FDA) previously issued emergency use authorizations (EUA) and adopted emergency policies in response to the COVID-19 public health emergency (PHE) to facilitate the availability of key medical devices such as in vitro diagnostic tests,…
Massachusetts DPH Delays Enforcement Penalties for State Surprise Billing Law
The Massachusetts Department of Public Health (DPH) has delayed the enforcement penalties for the new notice requirements under the “Patients First Law” until July 1, 2022. This news comes as a relief to the provider community that has been working…
COVID-19 At-Home Tests: Do CLIA Requirements Apply and what do Health Care Providers Need to Know?
Demand for COVID-19 tests, including over-the-counter at-home tests, has soared with the surge of the Omicron variant of the COVID-19 virus. However, health care providers, employers, and individuals have lacked clarity on if and how federal requirements might apply to…
The COVID-19 Vaccination Mandate: CMS is Ready for Enforcement … in Half of the United States
Despite continuing disputes as to the legality and enforcement of the CMS’ vaccine mandate for certified providers and suppliers, CMS has indicated it will proceed with enforcement of the mandate in those states where it is not enjoined from doing…