On Tuesday, January 9, 2024, the Centers for Medicare & Medicaid Services (“CMS”) approved a request from New York State (“NYS”) to amend its Medicaid section 1115(a) demonstration (the “Demonstration Amendment”),[1] which will allow for important expansion of the NYS Medicaid program, including:Continue Reading 2024 Brings Expansion to Medicaid in New York State

Congress passed the Corporate Transparency Act (the “CTA”) in 2021 with the aim of enhancing transparency in entity structures and ownership as well as combating terrorism, money laundering, and other forms of corporate misconduct. This sweeping new rule is designed to cast a wide net over entities that, except in the case of taxes, do not regularly report to federal agencies (i.e., non-publicly traded entities), regardless of the degree to which they are already regulated at the state level. This post specifically speaks to medical groups and management services organizations (“MSOs”) that now need to navigate the new CTA requirements and account for their complex contractual relationships (e.g., management services agreements, equity restriction or succession agreements). For additional information on a particular topic, links to helpful resources have been provided in the footnotes.Continue Reading The Corporate Transparency Act: A Reporting Guide for Medical Groups and MSOs

On December 13, 2022, the Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule, titled Advancing Interoperability and Improving Prior Authorization Processes (“Proposed Rule”), to improve patient and provider access to health information and streamline processes related to prior authorizations for medical items and services. We provided key information about that proposed rule on our website here. Then, on January 17, 2024, CMS issued a final rule, titled CMS Interoperability and Prior Authorization (“Final Rule”), which affirms CMS’ commitment to advancing interoperability and improving prior authorization processes.Continue Reading CMS Finalizes its Proposal to Advance Interoperability and Improve Prior Authorization Processes

1. Higher Jurisdictional Thresholds For HSR Filings

On January 22, 2024, the Federal Trade Commission announced revised, higher thresholds for premerger filings under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act). The jurisdictional thresholds are revised annually, based on the change in Gross National Product (GNP).Continue Reading Higher Jurisdictional and Filing Fees Thresholds for HSR Act Premerger Notifications and Interlocking Directorates Announced

On January 17, 2024, the Departments of Health and Human Services, Labor, and the Treasury (collectively, the “Departments”) and the Office of Personnel Management issued a notice that they will reopen the period for submitting comments on the proposed rule, “Federal Independent Dispute Resolution (IDR) Operations” (the “Proposed Rule”) under the No Surprises Act (the “Act”).Continue Reading Comment Period for the No Surprises Act Proposed Rule, “Federal Independent Dispute Resolution (IDR) Operations,” Will Reopen

Will your business have to go through the new Office of Health Care Affordability (OHCA) reporting regime for material healthcare transactions? What would such a filing involve, and how long would it take to complete the process? Those questions will be among key discussion items addressed in Sheppard Mullin’s upcoming webinar on February 7, 2024, co-sponsored with America’s Physician Groups and Moss Adams LLP. As we have highlighted in our blog series[1] on SB 184 and OHCA throughout the past year, OHCA’s recently finalized cost and market impact review (CMIR) regulations set forth the framework for OHCA’s authority to receive advance notice of and review a large scope of healthcare transactions in the coming months, reflecting a dramatic change to California’s healthcare regulatory landscape moving forward. Please tune in to this important webinar where our knowledgeable presenters will present an overview of the key components and practical considerations surrounding this new law, including:Continue Reading Webinar: New OHCA Rules Requiring Notice and Review of Material Healthcare Transaction

On December 28, 2023, the Office of Inspector General (the “OIG”) issued a favorable Advisory Opinion (No. 23-15) (the “Opinion”) to a consulting vendor (the “Requestor”) that wanted to provide up to $75 in gift cards to physician practices in exchange for referring the Requestor’s practice optimization services (e.g., workflow and performance assessment, data analytics, and certain Medicare eligibility and performance assistance). Among other things, the Requestor: (i) did not itself provide any services that were eligible for reimbursement under any Federal healthcare program to any of its clients, (ii) did not have an ownership or investment interest in any entity that provided items or services paid for by any Federal healthcare program, and (iii) received compensation from the physician practices that did not vary based on whether the physician practices received a greater or lesser reimbursement from Medicare based on the Requestor’s services. The Opinion concluded that this proposed arrangement would not generate prohibited remuneration under Section 1128B(b) of the Social Security Act (the “Act”), also known as the Federal Anti-Kickback Statute (“Anti-Kickback Statute”), and thus OIG would not impose administrative sanctions under Section 1128A(a)(7) (exclusion) or Section 1128(b)(7) (civil monetary penalty) of the Act on the Requestor. As always, the Opinion stipulated that it may only be relied on by the Requestor on the specific facts presented to OIG, and that certain state and federal laws may continue to limit similar arrangements. However, the Opinion indicates that the tight scope of potential marketing options for physician practice vendors could expand a bit for those who are similarly situated to the Requestor.Continue Reading New Marketing Possibilities for Vendors Contracted with Medicare Providers and Suppliers Following OIG’s Favorable Advisory Opinion on Limited Referral Bonuses

The 21st-century healthcare landscape has been dramatically shaped by the rise of digitized healthcare solutions aimed at making healthcare more accessible, affordable, and personalized. In the third episode of Sheppard Mullin’s Health-e Law Podcast, Viveka Rydell-Anderson, the CEO of Pacific Vision Foundation, delved into the increasing relevance of digital health technology, particularly in the area of specialized care, with Sheppard Mullin’s Digital Health Team co-chairs, Sara Shanti and Phil Kim.Continue Reading Digital Health to the Rescue – Improving Access to Specialized Care: A Discussion with Viveka Rydell-Anderson

Looking out at the San Francisco skyline from the top floor of the Westin St. Francis on Day 3 of the 42nd Annual J.P. Morgan Healthcare Conference, the iconic Transamerica pyramid is not too far away. But my mind, being chock-full of value-based care presentations, quickly imagines the building as the shining pyramid of patient segmentation and risk stratification, envisioning the proper way to sort patients for effective intervention and total cost of care reduction. John Kao, CEO of Alignment Healthcare, shared today that only 12% percent of their Medicare Advantage membership accounts for approximately 74% percent of their institutional cost (hospital and facility costs), while conversely their “healthy” membership of 74% accounted for only 5% of their institutional costs. These days, institutional costs and pharmaceutical costs are almost equal, according to the Advisory Board, and together far outweigh professional physician and other provider costs. Therefore, keeping patients out of the hospital and post-acute facilities as medically possible and appropriate and effectively managing medications should result in a large reduction in the total cost of care, right? So, what’s not happening that should be?Continue Reading Day 3 Notes from the 42nd Annual J.P. Morgan Healthcare Conference