On March 12, the Centers for Medicare & Medicaid Services (CMS) announced that certain Medicare value-based payment models will terminate early and signaled a new strategy will be announced soon. Specifically, the Centers for...more
On January 17, the Drug Enforcement Administration (DEA) and the U.S. Department of Health and Human Services (HHS) jointly published two final rules addressing the prescription of controlled substances via telemedicine in...more
On January 8, the governor of Massachusetts signed House Bill 5159 into law (Law). At a high level, the new Law expands Massachusetts’ existing health care transaction notice process and implements new reporting and oversight...more
On November 1, the Centers for Medicare & Medicaid Services (CMS) finalized its proposal to extend virtual direct supervision—i.e., the ability to provide direct supervision through real-time, audio-visual technology (rather...more
12/10/2024
/ Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
Medicare ,
MPFS ,
Outpatient Prospective Payment System (OPPS) ,
Physician Fee Schedule ,
Technology ,
Telehealth
New policies tucked into the Centers for Medicare and Medicaid Services’ (CMS) 2025 Medicare Physician Fee Schedule Rule (Final Rule) will likely spur increased Accountable Care Organization (ACO) participation in the...more
12/3/2024
/ ACOs ,
Beneficiaries ,
Centers for Medicare & Medicaid Services (CMS) ,
Final Rules ,
Health Care Providers ,
Medicare ,
Medicare Part A ,
Medicare Part B ,
Medicare Shared Savings Program ,
New Rules ,
Physician Fee Schedule ,
Physicians ,
Regulatory Requirements
On November 1, the Centers for Medicare & Medicaid Services (CMS) filed its Medicare Physician Fee Schedule (PFS) final rule (Final Rule) for calendar year (CY) 2025. As part of the Final Rule, CMS finalized Medicare coverage...more
Effective October 15, a new Final Rule issued by the Centers for Medicare & Medicaid Services (CMS) will allow the Medicare Shared Savings Program (MSSP) to adjust calendar year (CY) 2023 benchmark and expenditure...more
On September 13, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 24-08, in which it declined to approve a proposal by a Medicare Advantage organization (MAO)...more
9/19/2024
/ Advisory Opinions ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Employer Group Health Plans ,
Health Insurance ,
Healthcare ,
Medicare ,
Medicare Advantage Organizations (MAOs) ,
OIG ,
Shared Savings Program
On August 28, as part of its Fiscal Year 2025 Hospital Inpatient Prospective Payment System (IPPS) Final Rule, the Centers for Medicare & Medicaid Services (CMS) finalized the Transforming Episode Accountability Model (TEAM)...more
8/29/2024
/ Acute Facilities ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Final Rules ,
Health Care Providers ,
Hospitals ,
Inpatient Prospective Payment System (IPPS) ,
Mandatory Requirements ,
Medicare Part A ,
Medicare Part B ,
Value-Based Payments
On May 6, 2024, the Food and Drug Administration (FDA) published its final rule for laboratory developed tests (LDTs). The final rule cemented the agency’s forecasted decision to increase the FDA’s regulatory oversight of...more
The Centers for Medicare & Medicaid Services (CMS) recently proposed the Transforming Episode Accountability Model (TEAM) – a new, mandatory, episode-based alternative payment model in the Fiscal Year 2025 Hospital Inpatient...more
We are pleased to bring you our 12th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more
2/27/2024
/ Anti-Kickback Statute ,
CARES Act ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Kickbacks ,
Medical Devices ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Qui Tam ,
Settlement ,
Stark Law ,
Telemedicine
W ith various headwinds resulting in down volume in 2023, buyers and sellers alike find themselves asking whether 2024 will see a rebound in deal activity. As we begin 2024, we have highlighted the issues and trends that...more
1/9/2024
/ Acquisitions ,
Artificial Intelligence ,
Corporate Transparency Act ,
Department of Justice (DOJ) ,
Diversity ,
Equity Markets ,
FinCEN ,
Funding ,
Healthcare ,
Investment ,
Investors ,
Mergers ,
Non-Compete Agreements ,
Pharmaceutical Industry ,
Popular ,
Privacy Laws ,
Private Equity ,
Reporting Requirements ,
Restrictive Covenants ,
Risk Management ,
Safe Harbors ,
Section 340B ,
Self-Disclosure Requirements ,
Value-Based Care
On November 16, the Centers for Medicare & Medicaid Services (CMS) published its Medicare Physician Fee Schedule (PFS) final rule for calendar year 2024 (PFS Final Rule). According to the CMS press release, the PFS Final Rule...more
11/21/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Final Rules ,
Health Care Providers ,
Healthcare ,
Healthcare Facilities ,
Healthcare Reform ,
Medical Reimbursement ,
Medicare ,
Mental Health ,
New Regulations ,
Outpatient Prospective Payment System (OPPS) ,
Outpatient Services ,
Physician Fee Schedule ,
Physicians ,
Psychological Counseling ,
Telehealth
On September 25, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 23-06, in which it declined to approve an anatomic pathology laboratory’s proposal to purchase...more
On October 6, the Drug Enforcement Administration (DEA) and Substance Abuse and Mental Health Services Administration (SAMHSA) issued a temporary rule providing for a second temporary extension of its COVID-19 telemedicine...more
On October 3, the U.S. Food & Drug Administration (FDA) published a highly anticipated proposed rule (Proposed Rule) to regulate laboratory-developed tests (LDTs) as medical devices. LDTs are tests that are developed and...more
The U.S. Department of Health and Human Services Office of Inspector General (OIG) recently issued Advisory Opinion 23-03, approving a proposal by the manufacturer of a colorectal cancer screening test and its wholly owned...more
The Health Resources and Services Administration (HRSA) is seeking repayment of Provider Relief Fund (PRF) payments from providers who failed to submit the required report(s) on their use of the funds. Recipients were...more
On November 2, 2022, Centers for Medicare & Medicaid Services (CMS) filed its final rule implementing changes to the Medicare Physician Fee Schedule for CY 2023 (Final Rule). Embedded within this Final Rule are important...more
11/17/2022
/ ADLT ,
Bureau of Labor Statistics ,
Centers for Medicare & Medicaid Services (CMS) ,
CLFS ,
Clinical Laboratories ,
Data Collection ,
Fees ,
Final Rules ,
Home Health Agencies ,
Medicare ,
PAMA ,
Physician Fee Schedule
On November 2, 2022, the Centers for Medicare & Medicaid Services (CMS) filed its Medicare Physician Fee Schedule (PFS) final rule (Final Rule) for calendar year (CY) 2023. CMS finalized several noteworthy updates specific to...more
This client alert highlights recent regulatory developments from the Centers for Medicare & Medicaid Services (CMS) relevant to clinical laboratories. CMS is implementing or considering implementing several updates to the...more
On August 19, the federal government issued a final rule addressing certain aspects of the No Surprises Act (NSA). The NSA was enacted in December 2020 to protect commercially insured patients from receiving surprise medical...more
On April 28, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-09, declining to approve a laboratory company’s proposal to pay hospitals a fair market...more
5/6/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Clinical Laboratories ,
Enforcement Actions ,
Fair Market Value ,
Fraud ,
Hospitals ,
Kickbacks ,
OIG ,
Pay-Per-Click ,
Payment Services Directive ,
Remuneration ,
Risk Factors
On October 18, the Food and Drug Administration (FDA) issued a letter reminding developers of in vitro diagnostics (IVDs) that institutional review board (IRB) approval is required before initiating a clinical investigation...more
10/25/2021
/ Clinical Trials ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Investigational Device Exemptions ,
Investigations ,
IRB ,
Life Sciences ,
Medical Devices ,
Research and Development ,
The Common Rule