The Departments of Labor, Health and Human Services (“HHS”), and the Treasury (the “Tri-agencies”) released their 2022 annual report to Congress on the Mental Health Parity and Addiction Equity Act (“MHPAEA”) on Tuesday, January 25. The Employee Benefits Security Administration (“EBSA”) released an FY 2021 MHPAEA Enforcement Fact Sheet alongside the annual report. Together, the Tri-agencies’ report and EBSA fact sheet provide additional, important information for group health plans and health insurance issuers looking to comply with the 2021 Consolidated Appropriations Act’s (“CAA”) non-quantitative treatment limitation (“NQTL”) comparative analysis requirements. But plans and issuers need additional agency guidance. Continue Reading 2022 MHPAEA Annual Report Illuminates Tri-agency Review and Enforcement Priorities in a Post-Consolidated Appropriations Act World

On January 18, 2022, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) and the entity chosen as a contracting partner, The Sequoia Project, Inc., published the long-awaited Trusted Exchange Framework and Common Agreement (TEFCA) for health information exchange. In simple terms, TEFCA is a framework that health information networks (HINs) may enter into to share health data with other HINs, individuals, and entities. The stated goal of TEFCA is to develop uniform policies and technical requirements to scale health information exchange nationwide and ensure that HINs, health care providers, health plans, individuals, and other stakeholders can access real-time, interoperable health information. Continue Reading ONC Releases a Framework for Nationwide Health Information Exchange

On January 31, 2022, the U.S. Food & Drug Administration (FDA) published a notice in the Federal Register announcing the availability of a final guidance for industry and FDA staff entitled “Principles of Premarket Pathways for Combination Products”. The final guidance is available on the FDA’s website. It provides FDA’s current thinking on principles for premarket review of combination products. It finalizes previously available draft guidance, dated February 6, 2019, which altogether are part of FDA’s efforts to implement section 3038 of the 21st Century Cures Act expressly addressing combination products. The final guidance is nonbinding. Continue Reading FDA Finalizes Guidance on Combination Products

A recent survey of top decision-makers by Crowell & Moring finds that nearly 80% of responding companies have identified and adopted environmental performance goals beyond what regulations require. Fewer than half of those surveyed measure their company’s performance against those goals—and in some cases are experiencing challenges implementing them. Continue Reading Crowell & Moring Survey Finds Companies Are Setting Environmental Goals, But Questions of Measurement Persist

On October 27, 2021, the U.S. Food and Drug Administration (FDA) in collaboration with Health Canada, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), published Guiding Principles for the use of artificial intelligence and machine learning (AI/ML) in medical devices.   The principles are designed to support good machine learning practices (GMLP) and to help promote safe, effective, and high-quality medical devices that use AI/ML. The FDA is accepting public comment on these principles on an ongoing basis.

Continue Reading FDA Publishes Principles for AI and ML in Medical Devices

Today, CMS released its strategy for the CMS Innovation Center (the “Strategy”) in a White Paper, Innovation Center Strategy Refresh. This Strategy and the connection to broader CMS priorities was outlined by CMS Administrator Brooks-LaSure and CMS Innovation Center Director, Liz Fowler, in a webinar and is intended as a blueprint for the next 10 years.  While the Innovation Center’s overarching goal continues to be expansion of successful models that reduce program costs and improve quality and outcomes for Medicare and Medicaid beneficiaries, CMS highlights five strategic objectives: Drive Accountable Care, Advance Health Equity, Support Innovation, Address Affordability, and Partner to Achieve System Transformation and created a new vision: “A health system that achieves equitable outcomes through high-quality, affordable, and person-centered care.”

Continue Reading CMS Innovation Center Announces New Strategic Direction Under the Biden Administration

This article was originally published in Corporate Compliance Insights.

Both your company’s data supply chain and its physical version have fundamentally similar business risks. Given the consequences of unethical practices along both, enterprises can no longer ignore how data is sourced, how it is managed or where it is going.

While many organizations go to great lengths to monitor their physical supply chain, their data supply chain often gets short shrift. For any company interacting with large sets and various streams of information, this can represent a significant exposure to risk.

Since the first investigation under the U.S. FCPA concerning a third party acting on behalf of a U.S. company was initiated nearly 40 years ago, upholding integrity in global supply chains has garnered attention. Rightfully so, as compounding risks in physical production and movement of goods abound upstream (e.g., forced labor, conflict materials, environmental impact) and downstream (e.g., bribery, fraud, misuse). Continue Reading Is Your Data Supply Chain Ethical? Don’t Restrict Due Diligence to Physical Operations.

On May 14, 2021, CMS published FAQs addressing questions that have been raised regarding the Interoperability and Patient Access final rule published May 2020.  CMS is careful to note that the FAQs “do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract, as directed by a program.”  CMS has provided links and other guidance, including regarding technical standards, best practices, and privacy and security resources, and has directly addressed questions raised by trade associations and others.

We summarize some of the key points addressed in the FAQs.  We encourage you to review the full CMS response where questions arise in your implementation. Continue Reading CMS Issues First FAQs on the CMS Interoperability and Patient Access Rule

On November 13, 2020, the Centers for Medicare & Medicaid Services (“CMS”) published a final rule, demonstrating long-awaited efforts to streamline the regulatory framework governing the Medicaid and Children’s Health Insurance Program (“CHIP”) managed care programs.

According to CMS, the purpose of the final rule is to relax certain administrative burdens imposed by the Medicaid managed care rule promulgated by the Obama Administration in 2016. The 2016 rule (the “Mega Reg”), reflecting efforts to modernize the Medicaid and CHIP managed care programs and frustrate widespread fraud and abuse, was the first update to Medicaid managed care regulations in more than a decade.  The following blog post presents a brief summary of the final rule’s key changes.

Continue Reading 2020 Medicaid Managed Care Rule Summary

Earlier this month, OIG issued a Special Fraud Alert on Speaker Programs warning drug and device companies and health care providers that it has significant concerns about payments for “speaker programs.” Based on recent investigations and enforcement activity, the OIG has found that a number of speaker programs sponsored by drug and device manufacturers violate the federal Anti-Kickback Statute (AKS). OIG is skeptical about the educational value of speaker programs provided under circumstances that are not conducive to learning and to audience members who have no legitimate reason to attend. Additionally, OIG questions the value of such events given that health care providers can access the same or similar information online, on the product’s package insert, third-party educational conferences, medical journals, and more. Because all of this material is already available, OIG warns “that at least one purpose of remuneration associated with speaker programs is often to induce or reward referrals” in violation of the federal Anti-Kickback Statute (AKS).

OIG defined speaker programs as drug or device “company-sponsored events at which a [outside] physician or other health care professional (collectively, “HCP”) makes a speech or presentation to other [outside] HCPs about a drug or device product or a disease state on behalf of the company” using a presentation developed and approved by the company. HCPs are paid an honorarium and attendees are paid generally through free meals and drinks, for example.

Based on its investigations to date, OIG provided an illustrative list of speaker program characteristics that result in higher level of scrutiny with respect to AKS violations:

Continue Reading OIG Sends a Special Fraud Alert on Speaker Programs