As described in our blog post last year, an increasing number of states across the country are seeking to regulate physician practice management (“PPM”) and private equity transactions in the health care sector. As part of this trend, which generally appears to target private capital investors and large health
Healthcare
NYS DFS Revisits PBM Regulation with Scaled-Back Draft Rules
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including a dispensing fee of $10.18 per drug claim to be paid to pharmacies, but the proposed regulations were later withdrawn by the agency in October 2023 following the public comment period.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
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:
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
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…
HHS Publishes Roadmap of New Strategy for Cybersecurity in the Healthcare Sector
The U.S. Department of Health and Human Services (HHS) recently issued a strategy paper highlighting key aspects of its plan to revamp cybersecurity requirements in the healthcare industry. Citing a 93% increase in large data breaches in healthcare from 2018 to 2022 and a rapid increase in ransomware attacks against…
California Releases Proposed Regulations on Health Care Transaction Notice Requirements
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.
Medicare Advantage 2024 Rate Announcement – Further Impacts to Risk Adjustment
On Friday, March 31, 2023, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2024 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (Rate Announcement). This Rate Announcement follows CMS’s February 1 notice of planned changes to rates and the risk adjustment methodology, which provided an opportunity for the public to submit comments during a 30-day period (Advance Notice), as required by Section 1853(b)(2) of the Social Security Act (the Act). The Rate Announcement — providing for 60 days prior to the bid submission deadline of June 5, 2023 — provides notice of the annual capitation for MA for CY2024 related to the benchmark, risk adjustment, and other factors to be used in adjusting rates and responds to all substantive comments received from the Advance Notice.
We summarize the key factors and adjustments to the overall expected average rate increase of 3.32% (which is about $13.8 billion more than CY2023, and an increase from the 1.03% in the Advance Notice), and comments from CMS. We also highlight other key developments affecting MA rates, notably relating to the MA risk adjustment methodology (the 2024 Risk Model). Major changes identified in the Rate Announcement include updates to the risk adjustment model that uses International Classification of Diseases (ICD)-10 codes instead of the ICD-9 system, using data from 2018 diagnoses and 2019 expenditures, and the removal or reclassification of codes disproportionately coded in MA compared to Medicare Fee-For-Service (FFS) that CMS does not consider to accurately reflect increased costs to care for beneficiaries.
FTC’s One-Two Punch on Data Tracking and Health Privacy
On March 2, 2023, the Federal Trade Commission (FTC) announced that it had reached a $7.8 million settlement with mental health and online counseling platform, BetterHelp, Inc. (“BetterHelp”). The FTC alleged that BetterHelp shared consumers’ sensitive health data combined with other personal information (PI) with third party advertising platforms without…
Challenges to the No Surprises Act Continue: The Latest includes a Challenge to a 600% Increase in Administrative Fees
On February 6, 2023, a judge for the United States District Court for the Eastern District of Texas (“Texas District Court”) ruled in favor of the Texas Medical Association (“TMA”) and against the United States Departments of Treasury, Labor, and Health and Human Services (the “Departments”) over a challenge to…