On July 27, 2023, California’s Office of Health Care Access and Information (the “Office”) released its long-awaited proposed regulations on the notice requirements for material health care transactions in California. The anticipated regulations follow the passing of SB 184 on June 30, 2022, which, in part, created the Office and granted it the authority to collect and analyze data related to health care costs, specifically via monitoring mergers and acquisitions in the health care industry. Following the lead of states like New York, whose wide-range health care transaction requirements were discussed in a previous blog post, California seeks to address the increasing costs of health care services by imposing significant notice and review requirements for mergers and acquisitions beginning in 2024.
Legislation
2024 New York Budget Proposes Wide-Ranging Transaction Approval Requirement That Targets Private Investment in Physician Practices and MSOs, and Permits DOH to Extract Concessions
By David Manko & Jonian Rafti on
On February 1, 2023, New York Governor Kathy Hochul announced the 2024 Executive Budget. As alluded to in the Governor’s State of the State address, and as described in an earlier Proskauer Health Care Law Brief article, the Governor is proposing to adopt a wide-ranging approval requirement for health care transactions that appears to target investor-backed physician practices.
The legislative proposals related to health care, as contained in the Governor’s budget, were introduced as Senate Bill 4007 and Assembly Bill A3007. The bills propose to amend the Public Health Law (“PHL”) to introduce a new Article 45-A, named “Review and Oversight of Material Transactions.” See 2023 New York Senate-Assembly Bill S4007, A3007, Part M § 5.
The Future of Health Care Reform is Top of Governor Hochul’s State of the State Address
By Jacquelyn R. Daniel on
On January 10, New York’s Governor, Kathy Hochul, delivered the 2023 “State of the State” address. The address featured a number of health care reform initiatives—a strong indication that New York will prioritize health care issues and spending in the year ahead. Below is a summary of Governor Hochul’s…
Privacy Post-Dobbs
By Whitney Phelps & Angela Gichinga on
Fifty years of legal precedent established by Roe v. Wade, 410 U.S. 113 (1973), and Planned Parenthood of Southern Pa. v. Casey, 505 U.S. 833 (1992), were overturned in Dobbs v. Jackson Women’s Health Organization, holding that the Constitution does not confer a right to abortion and leaving…
Department of Health and Human Services Issues Request for Information on Cybersecurity Standards
By Ryan P. Blaney & Vincent J. Tennant on
The Department of Health and Human Services (“HHS”) has issued a formal request for information from the public about how regulated entities are implementing industry recognized security practices. The request for information represents a chance for the private sector to contribute to HHS regulation. Interested parties have until June 6,…
No Surprises Act’s Regulation Establishing QPA as Presumptive Payment Amount Vacated by District Court
By Edward S. Kornreich on
We previously noted that the No Surprises Act (NSA) regulation’s establishment of the presumption that the qualifying payment amount (QPA)—generally, the median payment by the plan to providers in the region—is the appropriate payment amount in arbitrations between plans and providers under the NSA did not appear to comport with…
New York Enacts Landmark Legislation Regulating PBMs
By Whitney Phelps & Angela Gichinga on
On December 31, 2021, New York Governor Kathy Hochul signed landmark legislation to increase the transparency of prescription drug pricing and to establish requirements on pharmacy middlemen. This new law is amongst 100 [1] state bills introduced in 2021 that shed light on the business practices of pharmacy benefit managers…
CMS releases guidance on Expanded Home Health Value-Based Purchasing (“HHVBP”) Model
By Whitney Phelps & Angela Gichinga on
On November 2, 2021, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule (“Final Rule”) that advances the shift from paying for Medicare home health services based on volume to a system that pays based on value. In addition to other matters, the Final Rule expands the…
False Claims Act Spotlight (2 of 3): Recent Proposed Amendments to the FCA Fall Short of Cohesive and Substantive Change
This is the second installment in our series of posts covering recent developments in False Claims Act (“FCA”) doctrine and practice, with the first post discussing the rescission of the “Brand Memo” and restoring the role of sub-regulatory guidance in FCA enforcement actions. A third post, to come later this week, will address recent federal court cases construing the FCA.
In July 2021, Senator Chuck Grassley led a bipartisan group of senators in introducing S.B. 2428, the “False Claims Amendments Act of 2021,” which aims to address legal developments in FCA doctrine that, according to the bill’s sponsors, made it “more difficult for plaintiffs and whistleblowers to succeed in lawsuits against government contractors engaged in fraud.” S.B. 2428 proposes amendments to the FCA in four key areas more fully described below:
- to shift the burden to defendants to disprove plaintiffs’ showing of materiality of alleged FCA misconduct;
- to provide a means by which the government can seek reimbursement for costs incurred for responding to burdensome discovery requests;
- to resolve a Circuit Court split regarding the appropriate standard of review for evaluating government’s (c)(2)(A) motions to dismiss qui tam complaints; and
- to extend the FCA’s anti-retaliation whistleblower protections.
The Surprises Continue: The Biden Administration Delays Implementation of Certain Provisions of the No Surprises Act and Transparency in Coverage Final Rules Applicable to Providers and Insurers
In a FAQ published on August 20, 2021, the Departments of Labor, Health and Human Services, and the Treasury (collectively, the “Departments”) significantly delayed implementation of statutory requirements on surprise billing and price transparency, which we had previously summarized in a series of blog posts throughout this past year:
- No Surprises: Congress Enacts Surprise Bill Law and Adds Mandatory Billing Transparency
- No Surprises in Initial No Surprises Act Regulations
- New Federal Transparency Requirements Impacting Health Providers and Plans
Specifically, the FAQs focus on the implementation of certain provisions of the Affordable Care Act’s (the “ACA’s”) Transparency in Coverage Final Rules (the “TiC Final Rules”) and certain provisions of title I (the No Surprises Act) and title II (Transparency) of Division BB of the Consolidated Appropriations Act, 2021 (the “CAA”).