As the largest public funder of biomedical research in the world, the National Institutes of Health (“NIH”) annually funds over $38 billion in extramural research, including about $6 billion for clinical trials. On May 28, 2024, OIG published a report (“OIG Report”) summarizing its finding that, of the NIH‑funded clinical trials randomly selected by OIG for review, a majority failed to meet NIH’s requirements for inclusion of diverse trial participants.
No Surprises Here! Divergent Court Rulings Spotlight Ongoing Challenges in No Surprises Act Implementation; Tee Up Split in Authority on Award Enforcement Mechanisms
By D. Austin Rettew & Vinay Kohli on
Two District Courts have reached opposite conclusions on the enforceability of arbitration awards under the No Surprises Act (“NSA”). The two decisions, while far from the final word on the subject, highlight the most recent challenge relating to the implementation of the NSA.
Enacted by Congress in 2020, the NSA…
New HIPAA Requirements Place Additional Privacy Obligations on Covered Entities and Patients in an Effort to Protect Reproductive Health Care Information
By Whitney Phelps & Michael Menconi on
On April 22, 2024, the Office for Civil Rights (OCR) for the United States Department of Health and Human Services issued a Final Rule amending the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA). The Final Rule, which goes into effect on June 25, 2024, promulgates…
Recent Circuit Litigation Continues to Highlight “But-For” Causation Requirement for the Government to Demonstrate an FCA Violation Predicated on an AKS Violation
By Matthew J. Westbrook & Vinay Kohli on
In recent years, a circuit split among the United States Courts of Appeals has emerged over how courts have interpreted the False Claims Act’s (“FCA”) causation element in cases where a violation of the Anti-Kickback Statute (“AKS”) is a predicate violation for the false claim. The spotlight is now on…
As Scrutiny Escalates, DOJ Announces the Formation of the Health Care Monopolies and Collusion Task Force
The U.S. Department of Justice (“DOJ”) recently announced the creation of the Health Care Monopolies and Collusion Task Force (the “HCMC Task Force”) aimed at resolving antitrust issues in the health care industry. Specifically, the HCMC Task Force will focus on investigating issues related to the quality of patient care…
Public Portal to Promote Healthy Competition
On Thursday, April 18, the Department of Justice (“DOJ”), the Federal Trade Commission (“FTC”), and the Department of Health and Human Services (“HHS”) announced the launch of an online portal that allows the public to report potential health care antitrust violations.
The portal, HealthyCompetition.gov, aims to advance government efforts…
California Considers New Restrictions as Health Care Notice Requirements Go Live for Transactions Closing on or After April 1
By Jacquelyn R. Daniel & Vinay Kohli on
In August 2023, we published a blog post about the California Office of Health Care Access and Information’s (“OHCA”) proposed cost and market impact review (“CMIR”) regulations under the California Health Care Quality and Affordability Act (“Proposed Regulations”). The final CMIR regulations implementing the notice requirements for large health care transactions in California (“Final Regulations”) were approved on December 18, 2023. As enacted, all health care entities that meet certain threshold requirements and are a party to a “material change transaction” expected to close on or after April 1, 2024, must provide at least 90 days’ advance notice to OHCA. OHCA began accepting notices as of January 1.
Continuing the trend towards greater scrutiny of health care transactions, on February 16, the California Assembly introduced a new bill, AB-3129, which would subject private equity groups and hedge funds to a 90-day notice and consent requirement for change of control transactions or acquisitions of health care facilities or provider groups that are expected to close on or after January 1, 2025. While the Final Regulations are intended to promote competition in the health care sector, the stated purpose of AB‑3129 is to improve the quality and lower the cost of health care.
This blog discusses the scope of the Final Regulations and what to look out for as AB-3129 makes its way through the California legislative process.
Oregon CPOM Bill Inches Closer to Becoming Law, Targeting Investors and the PPM/Friendly PC Model
Update as of 3/13/24:
House Bill 4130 died on March 4, 2024, after it failed to reach the Senate Floor. Representative Ben Bowman, the Bill’s chief sponsor, pledged to reintroduce the Bill as soon as the opportunity arises. The Bill garnered national attention as the latest state-led effort to regulate…
NYS DFS Revisits PBM Regulation with Scaled-Back Draft Rules
By Ashley Seibler & Whitney Phelps on
On February 6, 2024, the New York State Department of Financial Services (“DFS”) released “pre-proposed” consolidated rulemaking related to the business practices of Pharmacy Benefit Managers (“PBMs”) licensed to operate in New York.
The draft regulations represent DFS’s latest attempt to promulgate PBM market conduct rules following state PBM licensing legislation that was enacted in 2021. In August 2023, DFS issued proposed regulations addressing consumer protection, conflicts of interest, and transparency issues related to PBM industry practices, including a dispensing fee of $10.18 per drug claim to be paid to pharmacies, but the proposed regulations were later withdrawn by the agency in October 2023 following the public comment period.
DFS’s announcement of the draft regulations and pre-proposal comment period stated that the draft regulations were informed by DFS’s “extensive outreach to industry, health plans, pharmacy groups, state and federal regulators, and the general public.”
The Corporate Transparency Act: Key Considerations for Health Systems and Practice Management Companies (MSOs/DSOs)
In 2021, Congress enacted the Corporate Transparency Act (the “CTA”) to “better enable critical national security, intelligence, and law enforcement efforts to counter money laundering, the financing of terrorism, and other illicit activity.”[1] The CTA, which became effective January 1, 2024,[2] is described, in detail, in a series of Proskauer alerts compiled by Proskauer’s CTA Task Force. The CTA will create a national registry of the “beneficial owners” and “company applicants”[3] of millions[4] of entities across the country. A reporting company must disclose certain information about its beneficial owners and (for entities formed in 2024 and later) company applicants, including: (i) legal name; (ii) date of birth; (iii) residential address (or business address for certain company applicants); (iv) unique identifying number from a non-expired government-issued identification document; and (v) an image of such identification document.[5] In addition, states are following the Federal government’s lead and have adopted similar regulatory regimes; last month, for example, New York enacted the LLC Transparency Act, which comes into effect in December 2024.