Resource Library

Any entities that plan to invest or are already invested in digital health companies, entities that contract with them, or providers that offer in-house telehealth modalities must be aware of the significant regulatory oversight the industry faces. This article discusses the US Department of Health and Human Services' Office of Inspector General's Special Fraud Alert published on July 20, 2022, which was the same day the US Department of Justice announced a massive fraud takedown, targeting telemedicine providers and physicians that netted criminal charges against 36 defendants in schemes that allegedly defrauded the government out of more than $1.2 billion.

In the wake of the US Supreme Court’s decision to overturn Roe v. Wade, the US Department of Health and Human Services (HHS) Office of Civil Rights (OCR) issued new guidance to address patient privacy under the Health Insurance Portability and Accountability Act (HIPAA) for those seeking reproductive health care services. This article discusses the guidance, which states that HIPAA allows providers to disclose certain protected health information (PHI), which includes information relating to one’s abortion or other reproductive care, without patient authorization only in specific circumstances that are “narrowly tailored to
protect the individual’s privacy and support their access to health services.”

Check out this article by Foley & Lardner in response to an unprecedented move by the U.S. Food and Drug Administration (FDA or Agency) detailing a warning letter sent to Amazon.com, Inc. (Amazon), a fulfillment house, with respect to distributing over-the-counter (OTC) drug products that are in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

On August 15, 2022, the Federal Trade Commission (FTC)—in a bipartisan, 5-0 vote—issued a policy paper detailing its concerns with Certificates of Public Advantage (COPAs). Check out this article by Foley & Lardner article detailing the policy paper and the future of the FTC and COPAs.

On August 17, 2022, the Centers for Medicare and Medicaid Services (CMS) issued a bulletin (Bulletin) to states addressing potentially inappropriate cost-based proposals and practices related to governmental ambulance providers in the delivery of ground emergency medical transportation to Medicaid beneficiaries (GEMT). Check out this article by Foley & Lardner detailing the CMS bulletin.

Read this article from Foley & Lardner to find out how President Biden's Inflation Reduction Act affects the healthcare industry.

Check out this Foley & Lardner article detailing the steps California is taking to ensure access to abortion care in response to Dobbs v Jackson.

The Centers for Medicare and Medicaid Services (CMS), as part of 2023 Physician Fee Schedule proposed rule, has proposed significant revisions to the Medicare Shared Savings Program (MSSP). The revisions to the MSSP in the proposed rule (the Rule) are designed to address the lack of growth in beneficiary participation in the MSSP and the fact that higher spending beneficiary populations, and racial and minority beneficiaries are increasingly underrepresented in the MSSP. Read this article by Foley & Lardner to learn more about the proposed revisions to the MSSP.

This guide provides a compilation of insights from legal practitioners around the world to assist in the identification and understanding of the laws and regulations that impact the drug and medical device industry.

On April 23, 2024, the U.S. Federal Trade Commission finalized a rule, by a vote of 3-2, abolishing the vast majority of employee covenants not to compete across the United States.

While certain health care providers will be exempted from the rule, many will not. As such, and if the rule survives legal challenge, health care industry participants should carefully consider how the rule will impact their recruitment and retention strategies going forward.