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…

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…

On October 29, 2020, the Departments of Health and Human Services, Labor, and the Treasury (“the Departments”) issued a final rule requiring private-sector health insurers and self-insured health plans to disclose treatment prices and cost-sharing information with consumers.  The Transparency in Coverage rule comes in response to President Trump’s executive order aiming to increase transparency in the healthcare industry. It is slated to become effective on January 11, 2021. The final rule contains three main parts:…

On October 29, 2020, CMS issued the Home Health Prospective Payment System final rule [CMS-1730-F, CMS-1744-IFC, and CMS-5531-IFC], which permanently authorizes use of telecommunications technology as part of patient care under the Medicare home health benefit.[1] The final rule is another regulatory step toward CMS recognizing the critical role of virtual care in the home health and other care settings, beyond the COVID-19 pandemic.[2] Use of Telecommunications Technology in Home Health…

Last week, the Office of the National Coordinator for Health Information Technology (ONC)  published an Interim Final Rule: Information Blocking and the ONC Health IT Certification Program: Extension of Compliance Dates and Timeframes in Response to the COVID-19 Public Health Emergency (Interim Final Rule) providing needed relief to entities working toward compliance.  In the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule (ONC Rule), issued on May…

On August 20, 2020 the Department of Health and Human Services (HHS) published a notice of proposed rulemaking (85 Fed. Reg. 51397) on good practices for the release and maintenance of agency guidance documents. Comments must be posted by 11:59 pm on September 16, 2020. As instructed in the October 9, 2019 Executive Order 13891 (EO), titled ‘‘Promoting the Rule of Law Through Improved Agency Guidance Documents (84 FR 55235 (Oct. 15, 2019)),…

Payers, Providers, and Patients – Oh My! Is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors. In this episode, hosts Payal Nanavati and Joe Records sit down with Todd Rosenberg and Samuel Krause to discuss ERISA preemption of state regulation of pharmacy benefit managers (PBMs) in light of the upcoming U.S. Supreme Court hearing in Rutledge v. Pharmaceutical Care Management Association. Subscribe…