SB 1120 (the “Bill”), which takes effect on January 1, 2025, amends existing California law to adopt guardrails around the use of artificial intelligence tools for the purpose of utilization management. As discussed in a...more
12/24/2024
/ Algorithms ,
Anti-Discrimination Policies ,
Artificial Intelligence ,
Audits ,
California ,
Centers for Medicare & Medicaid Services (CMS) ,
CMIA ,
Health Insurance ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Medical History ,
Medicare Advantage Organizations (MAOs) ,
New Legislation ,
Personal Information ,
Physicians ,
Policies and Procedures ,
Software
On December 11, 2024, the Office of Inspector General for the U.S. Department of Health and Human Services (“OIG”) issued a special fraud alert warning about certain marketing schemes that involve questionable payments and...more
12/18/2024
/ Anti-Kickback Statute ,
Compliance ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud Alerts ,
Health Care Providers ,
Marketing ,
Medicare Advantage ,
OIG ,
Telemedicine ,
Third-Party
In the context of Medicare Advantage (“MA”) reform initiatives, we previously addressed the Centers for Medicare & Medicaid Services’ (“CMS”) December 27, 2022 proposal to amend its regulations set forth at 42 C.F.R. §...more
8/6/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
False Claims Act (FCA) ,
Final Rules ,
Healthcare Fraud ,
Investigations ,
Medicare Advantage ,
Medicare Part D ,
Overpayment ,
Physician Fee Schedule ,
Proposed Rules ,
Regulatory Reform ,
Reporting Requirements ,
Voluntary Disclosure
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,...more
7/25/2024
/ 21st Century Cures Act ,
Affordable Care Act ,
Artificial Intelligence ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Diversity ,
Final Rules ,
Food and Drug Administration (FDA) ,
National Institute of Health (NIH) ,
OCR ,
OIG
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...more
6/24/2024
/ Attestation Requirements ,
Audits ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Dobbs v. Jackson Women’s Health Organization ,
False Claims Act (FCA) ,
Final Rules ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
HIPAA Violations ,
Medicaid ,
Medicare ,
OCR ,
OIG ,
Patients ,
PHI ,
Popular ,
Reproductive Healthcare Issues ,
SCOTUS
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. ...more
5/23/2024
/ Antitrust Division ,
Collusion ,
Data Protection ,
Department of Justice (DOJ) ,
Federal Trade Commission (FTC) ,
Healthcare ,
Investigations ,
Monopolization ,
Patients ,
Private Equity ,
Technology
Past long-standing chair of Proskauer’s Health Care Department, Ed Kornreich is a recognized authority on the legal, regulatory and business issues related to health care… Past long-standing chair of Proskauer’s Health Care...more
4/26/2024
/ Antitrust Provisions ,
Competition ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
FTC Act ,
Hart-Scott-Rodino Act ,
Healthcare ,
Robinson-Patman Act ,
Sherman Act ,
The Clayton Act
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...more
2/20/2024
/ Audits ,
Licensing Rules ,
NYDFS ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drug Coverage ,
Proposed Regulation ,
Public Comment ,
Regulatory Agenda ,
Reimbursements ,
Rulemaking Process
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...more
2/8/2024
/ Budgets ,
Cybersecurity ,
Drug Pricing ,
Executive Branch ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Home Health Care ,
Hospitals ,
Medicaid ,
Mental Health ,
New Legislation ,
Proposed Legislation
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...more
2/5/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Health and Essential Rights (HERO) Act ,
Healthcare ,
Insurance Industry ,
MCOs ,
Medicaid ,
Mental Health ,
New Amendments ,
New York ,
Social Security Act ,
State Budgets ,
Value-Based Payments ,
Waivers
A conversation with Kindbody’s Dr. Fahimeh Sasan and Proskauer partner Whitney Phelps on how more dialogue can increase opportunities in the sector. There has been a massive shift in the conversation around women’s health,...more
On April 5, the Centers for Medicare & Medicaid Services (“CMS”) released the 2024 Medicare Advantage and Prescription Drug Benefit Programs Final Rule (“Final Rule”), which will be codified at 42 C.F.R. Parts 417, 422, 423,...more
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...more
“We continue to see interest across the health care M&A vertical and buyers need to be ready to move quickly when attractive assets come on the market. The current environment rewards potential acquirers who are willing to...more
10/19/2022
/ Acquisitions ,
Antitrust Violations ,
Carve Out Provisions ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Healthcare ,
Industry Consolidation ,
Risk Assessment ,
State Regulators ,
Valuation ,
Vertical Mergers
The Centers for Medicare & Medicaid Services (“CMS”) recently published the proposed 2023 Physician Fee Schedule (“PFS”), which contains several important changes affecting Accountable Care Organizations (“ACOs”) that...more
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...more
7/11/2022
/ Abortion ,
Dobbs v. Jackson Women’s Health Organization ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HIPAA Privacy Rule ,
Patient Access ,
Patient Privacy Rights ,
PHI ,
Reproductive Healthcare Issues ,
Roe v Wade ,
SCOTUS
This past week, the Supreme Court of the United States (Supreme Court) denied UnitedHealthcare Insurance Company’s (UnitedHealthcare) petition for a writ of certiorari (Petition) challenging, in part, the Centers for Medicare...more
As part of the Fiscal Year 2023 New York state Executive Budget legislation, $1.2 billion in funding has been allocated for the payment of bonuses for certain “frontline” healthcare workers.
With the stated goals to...more
5/11/2022
/ Audits ,
Bonuses ,
Essential Workers ,
Healthcare ,
Healthcare Workers ,
Home and Community Based Services (HCBS) ,
Medicaid ,
New York ,
State Budgets ,
State Funding ,
Wage and Hour
The 21st Century Cures Act directed the National Coordinator to “develop or support a trusted exchange framework, including a common agreement among health information networks nationally.” Fulfilling that mandate, the Office...more
On February 24, 2022, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS), announced the Accountable Care Organization Realizing Equity, Access, and Community Health (ACO REACH)...more
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 ...more
1/19/2022
/ Drug Pricing ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
New Legislation ,
New York ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Price Transparency ,
TPAs
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...more