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.
Healthcare
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…
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…
Oregon CPOM Bill Inches Closer to Becoming Law, Targeting Investors and the PPM/Friendly PC Model
By Jason S. Madden, Jonian Rafti & Michael Menconi on
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 Key Health Care Initiatives Proposed in Governor Hochul’s Fiscal Year (FY) 2025 Executive Budget
By Jacquelyn R. Daniel & Whitney Phelps on
This year’s Health and Mental Hygiene Bill (“HMH Bill”) (part of the Governor’s FY 2025 Executive Budget, which proposes a $233 billion balanced budget), includes $35.5 billion to fund Medicaid, $4.8 billion to address serious mental illness and $6 billion in federal funding through the 1115 Waiver.
In addition to those provisions that look to extend current government programs, the HMH Bill proposes the following new initiatives:
Using OIG’s Cross-Component Audit and Enforcement Data to Strengthen Your Compliance Program
By Matthew J. Westbrook on
The U.S. Department of Health and Human Services Office of Inspector General’s (OIG) core responsibility is to promote efficiency and economy in myriad programs by eliminating fraud, waste and abuse. For years, compliance professionals have come to rely on OIG’s advisory opinions, special fraud alerts, advisory bulletins and industry-specific guidance…
Long Awaited Approval of the 1115 Waiver Amendment for New York State Medicaid – Just in Time for the Executive Budget State Fiscal Year (SFY) 2025
By Whitney Phelps & Michael Menconi on
On Tuesday, January 16, 2024, Governor Kathy Hochul released the SFY 2025 New York State Executive Budget (“Executive Budget”). While still subject to legislative approval, the Executive Budget incorporates the recently approved amendment (“Waiver Amendment”) to New York’s Medicaid Section 1115 Demonstration that includes $7.5 billion in Medicaid investments over…
Cybersecurity a Top Priority – HHS Publishes New Cybersecurity Performance Goals
The U.S. Department of Health and Human Services (“HHS”) has expanded upon its recent Healthcare Sector Cybersecurity Concept Paper (which we covered in a prior blog post), issuing cybersecurity performance goals (“CPGs”) for the healthcare and public health (“HPH”) sector. These CPGs aim to help healthcare organizations protect against…