In response to concerns about the confidentiality of protected health information (PHI) related to reproductive health care less than one year after Dobbs v. Jackson Women’s Health Organization decision, and the prospect of such PHI being weaponized by states and used against patients, the U.S. Department of Health & Human Services Office for Civil Rights (OCR) has proposed amendments to the HIPAA Privacy Rule to protect that information.

The Centers for Medicare & Medicaid Services (CMS) recently published the Advancing Interoperability and Improving Prior Authorization Processes Proposed Rule (Prior Authorization Proposed Rule), and, if certain components are finalized, impacted payors will be required to be in compliance by January 1, 2026. The Prior Authorization Proposed Rule is meant to build upon the CMS Interoperability and Patient Access Final Rule (Patient Access Final Rule) and includes five proposals aimed at, according to CMS, increasing efficiency, reducing overall payor and provider burden, and improving patient access to electronic health information (EHI). Impacted health care payors include Medicare Advantage (MA) Organizations, Medicaid Managed Care Plans and Children’s Health Insurance Program (CHIP) Managed Care Entities, State Medicaid and CHIP Fee-for-Service (FFS) Programs, and Qualified Health Plan (QHP) Issuers on the Federally Facilitated Exchanges (FFEs). Among the more significant changes in the rule was the inclusion of MA Organizations as impacted payors.

The Federal Trade Commission (FTC) recently kicked off enforcement of its Health Breach Notification Rule (Breach Rule) by taking aim at GoodRx’s use of tracking technologies (e.g. pixels) and the sharing of consumer health data for advertising purposes. According to Samuel Levine, director of the FTC's Bureau of Consumer Protection, the FTC “is serving notice that it will use all of its legal authority to protect American consumers' sensitive data from misuse and illegal exploitation." Bottom line, HIPAA applicability may no longer be as significant of a factor when it comes to the risk presented by collecting, using, disclosing, and maintaining identifiable health information (IHI).

Bridgette Keller speaks with the Mintz Health Law team about what they are grateful for as they look back on a year of client service, mentorship, and working together as a team.

As illustrated by a recent Office for Civil Rights (OCR) settlement with a dental practice, health care entities continue to struggle with how to respond to negative online reviews while maintaining compliance with the HIPAA Privacy Rule. Given the significant reputational harm that negative reviews on Yelp and other social media and public platforms (Platforms) can create, providers may be tempted to respond to such negative comments with patient specifics in an attempt to mitigate harm to their businesses.

The Pandemic Response Accountability Committee (PRAC) Health Care Subgroup recently published an expansive report that highlighted the sheer volume of expanded access to and use of telehealth services in certain federal health care programs during the first year of the COVID-19 pandemic. The report also focused on program integrity risks related to this expanded use and included recommended safeguards for future oversight of telehealth services.

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The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) has been busy over the past month announcing new enforcement actions and settlement agreements related to violations of the Privacy Rule implemented under the Health Insurance Portability and Accountability Act (HIPAA). OCR’s latest actions offer a reminder for HIPAA Covered Entities that Privacy Rule enforcement activity can come in a variety of types and sizes.

Pharmacies have long been a focus of enforcement actions brought by the Department of Justice (DOJ) and Department of Health and Human Services Office of Inspector General (OIG). This summer has been no exception, with the DOJ and OIG bringing a number of fraud cases against pharmacies and pharmacists. We also saw enforcement against pharmacies for allegedly falsifying prior authorization information and providing more insulin than the pharmacy billed to payors. This blog summarizes some of these and other key pharmacy enforcement trends this summer.

Important developments related to required price reporting to Medicare for clinical laboratories under the Protecting Access to Medicare Act of 2014 (PAMA)  have recently occurred.  As a result, the clinical laboratory industry is hopeful that Medicare cuts scheduled to resume in 2023 and other aspects of PAMA’s price reporting requirements will be reformed. This blogpost provides an analysis of the ACLA lawsuit and newly introduced legislation that amends PAMA.