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OCR Proposes HIPAA Amendments to Protect Reproductive Health Care Information
April 13, 2023 | Blog | By Dianne Bourque, Kate Stewart, Pat Ouellette
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.
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FTC Sends Notice of Potential Penalties to Approximately 670 Companies Regarding Substantiation of Advertising Claims
April 13, 2023 | Blog | By Bruce Sokler, Joanne Hawana, Robert Kidwell, Benjamin Zegarelli
CMS Builds Upon Interoperability Rules with Prior Authorization Proposal
April 12, 2023 | Blog | By Pat Ouellette
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.
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The Sixth Circuit Adopts Narrow Interpretations of “Causation” and “Remuneration” for False Claims Act Suits Based on Alleged Kickback Schemes
April 6, 2023 | Blog | By Brian Dunphy, Grady Campion
OIG Issues Favorable Advisory Opinion on Gift Cards to Incentivize Patients to Return Samples for At-Home Colorectal Cancer Screening
April 4, 2023 | Blog | By Rachel Yount, Ryan Rasdall
The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued yet another favorable Advisory Opinion on the use of gift cards to motivate patients to receive medically necessary or preventive care services. The proposed arrangement involves an in-home colorectal cancer screening company’s proposal to provide gift cards of up to $75 to encourage patients to return their samples for their colorectal cancer screening. Though the OIG noted that the gift cards implicate the federal Anti-Kickback Statute (AKS) and the Beneficiary Inducements CMP because they would influence patients to receive reimbursable services from the requestor, the OIG concluded that the arrangement presented a minimal level of risk.
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Medical Device Developers Now Required to Incorporate Cybersecurity Plans into FDA Premarket Submissions for “Cyber” Devices
March 30, 2023 | Blog | By Joanne Hawana
One of the new Food and Drug Omnibus Reform Act requirements is that developers of “cyber devices” design and implement plans to “monitor, identify and address” cybersecurity vulnerabilities of marketed devices and to submit those plans to FDA as part of every new product application for a cyber device. The amended law defines a “cyber device” as one that includes software, connects to the internet, and contains any technological features that could be vulnerable to cybersecurity threats.
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Massachusetts to End Public Health Emergency
March 23, 2023 | Blog | By Ryan Rasdall
On March 15, 2023, Massachusetts Governor Maura Healey and Lieutenant Governor Kim Driscoll announced that the state’s COVID-19 public health emergency would end on May 11, 2023, in conjunction with the federal government’s end date for the public health emergency. This announcement by the Healey-Driscoll administration puts state organizations on notice, as required by law, at least 45 days ahead of the changes. As part of this announcement, Governor Healey also announced that she will be (i) rescinding Executive Order 595 which required state employees to be vaccinated against COVID-19, and (ii) proposing new legislation that allows for further flexibility in health care settings.
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FDA Modernizes Mammography Regulations, Provides Facilities with Eighteen-Month Compliance Deadline
March 20, 2023 | Blog | By Joanne Hawana, Jane Haviland
The AI Search Engine Doctor Is Always In: What Are the Regulatory and Legal Implications?
March 14, 2023 | Blog | By Benjamin Zegarelli, Daniel Herling
The information age in which we live is reaching a new milestone with the development and ready access to conversational artificial intelligence based on advanced transformer algorithms, or AI chatbots, including their upcoming integration into multiple Internet search engines. This development creates exciting opportunities and potentially terrifying risks in the health care space. Inevitably, people will ask AI chatbot-enabled search engines for information on diseases, conditions, medicines, or medical devices and use the response in some way to make certain medical decisions. But what happens when the AI chatbot’s response is inaccurate or even provides advice that may lead to harm if the user follows it? Can AI chatbots be regulated by the U.S. Food and Drug Administration (FDA)? What are the liability implications if a user is harmed? We provide some initial thoughts on such legal issues in this post.
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Federal Trade Commission’s GoodRx Settlement: Not Just a $1.5 Million Penalty
March 8, 2023 | Blog | By Lara Compton, Pat Ouellette
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).
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Telehealth Update: DEA Issues Long-Awaited Proposed Rule on Prescribing Controlled Substances via Telehealth
March 3, 2023 | Blog | By Ellen Janos, Cassandra Paolillo
With just over two months before the COVID-19 Public Health Emergency (PHE) expected expiration on May 11, 2023, the Drug Enforcement Agency (DEA) has finally announced its proposed rule on prescribing controlled substances via telehealth. This post provides continued coverage of telehealth updates and dissects what this DEA's proposed rule could entail.
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New York Proposes Regulatory Review and Approval of Material Health Care Entity Transactions
March 1, 2023 | Blog | By Jean D. Mancheno, Pamela Polevoy, Lara Compton
On February 1, 2023, New York Governor Kathy Hochul announced the Fiscal Year 2024 New York State Executive Budget (the Executive Budget). One component of the Executive Budget’s Health and Mental Hygiene Article VII Legislation is a proposal to require certain “health care entities” to obtain approval from the New York State Department of Health (DOH) prior to consummating a material transaction.
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EnforceMintz: False Claims Act Statistical Year in Review — A Study in Contrasts
February 27, 2023 | Article | By Kevin McGinty
Mintz's Health Care Enforcement group analyzes trends in False Claims Act (FCA) investigations and lawsuits using data compiled its Qui Tam Database, the Department of Justice's (DOJ) annual report of FCA statistics, and the DOJ’s discussion of FCA enforcement trends.
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CMS Proposes New Disclosure of Ownership Regulations for Nursing Facilities - Top Five Takeaways for Private Equity Firms and REITs
February 21, 2023 | Blog | By Lauren Moldawer, Karen Lovitch
Private equity ownership of health care providers is unquestionably under scrutiny by federal and state regulators. States are passing laws that either directly or indirectly target PE health care transactions. This post highlights the top five takeaways related to the proposed regulations for private equity companies or real estate investment trust ownership.
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Health Care Deal Structures: What Will the Deal Look Like?
February 15, 2023 | Blog | By Pamela Polevoy, Deborah Daccord, Cody Keetch
Deal structure is the foundation of a health care transaction. This post offers practical tips and hypothetical case studies for laying the groundwork for a successful health care transaction.
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FDA’s Digital Health High Notes from 2022
February 13, 2023 | Blog | By Benjamin Zegarelli
There has been a lot of discussion of the Food and Drug Omnibus Reform Act of 2022 (FDORA), which was enacted on December 29, 2022 as part of the larger Consolidated Appropriations Act for 2023, but we should also take a moment to review last year’s actions and policy updates on digital health from the Food and Drug Administration (FDA). The year 2022 marked the conclusion of the five-year Software Precertification Pilot Program and the release of the final Clinical Decision Support Software guidance, among other things (both described below); however, major digital health policy updates and announcements were few and far between. In this post, we summarize the agency’s key actions in the digital health space in 2022.
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EnforceMintz Newsletter — Quick Hits
February 9, 2023 | Blog | By Karen Lovitch
EnforceMintz — 2022 Saw the Expansion of EKRA Outside of the Addiction Treatment Setting
February 9, 2023 | Blog | By Kathryn Edgerton
EnforceMintz — With Telemedicine Here to Stay, Enforcement Agencies Continued their Scrutiny
February 9, 2023 | Blog | By Karen Lovitch
Getting The Deal Done! Best Practices For Health Care Transactions
February 9, 2023 | Webinar
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