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 April 4, the Centers for Medicare & Medicaid Services (CMS) issued the Contract Year (CY) 2025 Medicare Advantage (MA) Final Rule (Final Rule), which will have significant implications for MA plans and other industry...more
4/16/2024
/ Agents ,
Anti-Competitive ,
Beneficiaries ,
Brokers ,
Centers for Medicare & Medicaid Services (CMS) ,
Equity ,
Final Rules ,
Healthcare ,
Marketing ,
MCOs ,
Medicaid ,
Medicare Advantage ,
Medicare Part D ,
Mental Health ,
Shareholders ,
Third-Party Service Provider
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 15, CMS published a proposed rule, which, as currently written, has potentially significant implications for Medicare Advantage (MA) plans and Medicare Prescription Drug Benefit Program (PDP) plans in Contract...more
11/16/2023
/ Brokers ,
Centers for Medicare & Medicaid Services (CMS) ,
Compensation ,
Health Care Providers ,
MCOs ,
Medicare Advantage ,
Mental Health ,
Opioid ,
Proposed Rules ,
Quotas ,
Risk Assessment ,
Telehealth
As addressed in the first installment of this three-part series, healthcare providers face potential audits from an increasing number of Medicare and Medicaid contractors. Failing to respond properly can lead to significant...more
On February 1, the Centers for Medicare & Medicaid Services (CMS) published the Medicare Advantage (MA) Risk Adjustment Data Validation (RADV) Program Final Rule (Final Rule), which will take effect on April 3, 2023. The...more
On December 14, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule that contemplates several changes to, and clarifications of, guidance for the Medicare Advantage (MA) program in coverage year 2024....more
12/21/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Equity ,
Health Care Providers ,
Marketing ,
Medicare ,
Medicare Advantage ,
Medicare Part A ,
Medicare Part B ,
Medicare Part C ,
Medicare Part D ,
Notice Requirements ,
Overpayment ,
Proposed Rules ,
Star Ratings ,
Termination Clauses ,
Translations ,
Utilization Review
On November 14, Judge Edward Chen in the Northern District of California issued rulings on the pending motions to dismiss in U.S. ex rel. Osinek v. Kaiser Permanente, granting in part and denying in part Kaiser’s motion to...more
In a decision issued on September 30, Judge Andrew Carter of the U.S. District Court for the Southern District of New York denied Anthem Inc.’s motion to dismiss a government lawsuit filed in March 2020 claiming Anthem...more
10/7/2022
/ Anthem Insurance ,
Dismissals ,
Failure to Comply ,
False Claims Act (FCA) ,
Insurance Litigation ,
Kaiser Permanente ,
Medical Billing Codes ,
Medicare Advantage ,
Medicare Part C ,
New York ,
Overpayment
In a September 2022 filing in U.S. ex rel. Osinek v. Kaiser Permanente, the Kaiser Permanente consortium defendants (Kaiser) highlighted the distinction between clinically inaccurate diagnoses (factual falsity) and clinically...more
10/7/2022
/ Clinical Evaluations ,
Enforcement ,
False Claims Act (FCA) ,
Health Care Providers ,
Kaiser Permanente ,
Managed Service Providers (MSPs) ,
Medical Billing Codes ,
Medicare Advantage ,
Objective Falsity ,
Physicians ,
Qui Tam ,
Regulatory Oversight
The Centers for Medicare & Medicaid Services (CMS) recently issued Advisory Opinion No. CMS-AO-2021-01, clarifying that physician groups that furnish designated health services (e.g., laboratory, imaging) through wholly-owned...more
Ensuring compliance with the False Claims Act has never been more important for healthcare providers. By March 2020, we saw healthcare professionals standing at the forefront of one of the greatest health crises in a...more
2/4/2021
/ Annual Reports ,
Anti-Kickback Statute ,
CARES Act ,
Coronavirus/COVID-19 ,
Criminal Investigations ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Fraud ,
Long Term Care Facilities ,
Medical Devices ,
Medicare ,
Medicare Advantage Organizations (MAOs) ,
Nurses ,
Nursing Homes ,
OIG ,
Opioid ,
Pharmaceutical Industry ,
Pharmacist ,
Physicians ,
Qui Tam ,
Settlement Agreements ,
Stark Law ,
Telemedicine
The COVID-19 pandemic has stressed the M&A market at every stage of the deal-making process – from complicating on-site visits and intensifying the diligence process to introducing valuation gaps (relative to pre-COVID-19...more
12/7/2020
/ Accelerated Payments ,
Buyers ,
CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Economic Injury Disaster Loans ,
Employee Retention ,
False Claims Act (FCA) ,
Families First Coronavirus Response Act (FFCRA) ,
Government Investigations ,
Indemnification ,
Loan Forgiveness ,
Main Street Lending Programs ,
Material Adverse Effects ,
Paycheck Protection Program (PPP) ,
Payroll Taxes ,
Private Equity ,
Provider Relief Fund ,
Representations and Warranties ,
SBA ,
Securities and Exchange Commission (SEC) ,
Sellers ,
SIGPR ,
Tax Credits ,
Tax Deferral
Specialty pharmacies should carefully evaluate their relationships with drug manufacturers and charitable assistance programs in light of an August $3.5 million settlement between the United States Department of Justice (DOJ)...more
Widespread testing of patients and the public for COVID-19 exposure appears to be the key to reopening society sooner rather than later. Current estimates suggest that clinical laboratories across the United States have...more
Under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), the federal government is delivering a significant influx of money to the healthcare industry, particularly healthcare organizations, to aid in the...more
Despite the mounting pressures on healthcare entities related to the COVID-19 (coronavirus) pandemic and recent announcements of regulatory waivers and flexibility in particular areas, regulators are still showing interest in...more
The financial relief programs enacted by the Coronavirus Aid, Relief, and Economic Security (CARES) Act stand ready to provide crucial financial support to people and businesses impacted by the novel coronavirus (COVID-19)...more
As the impact of the COVID-19 pandemic continues to spread, the federal government is preparing to take unprecedented action to curb its effects on the nation’s health and economy by freeing up federal dollars for private...more
As the impact of the COVID-19 pandemic continues to spread, the federal government is preparing to take unprecedented action to curb its effects on the nation’s health and economy by freeing up federal dollars for private...more
On March 23, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) updated its Work Plan in response to the COVID-19 pandemic. The OIG Work Plan sets forth planned or ongoing agency evaluations,...more
3/28/2020
/ Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Guidance Update ,
Hospitals ,
Inspections ,
Nursing Homes ,
OIG ,
Public Health Emergency ,
Refugees ,
Unaccompanied Minors ,
Work Plans
In a remarkable move, the Department of Justice (DOJ) recently sought dismissal of 11 False Claims Act (FCA) cases, each of which assert that patient assistance services supplied by pharmaceutical manufacturers constitute...more
Recent opinions by the Fifth Circuit, the Northern and Southern Districts of Texas, and the District of South Carolina offer hope to providers seeking relief from substantial monetary recoupments during the Medicare appeals...more
9/28/2018
/ Administrative Appeals ,
Administrative Law Judge (ALJ) ,
Administrative Remedies ,
Audits ,
Centers for Medicare & Medicaid Services (CMS) ,
Complaint Procedures ,
Health Care Providers ,
Injunctive Relief ,
Irreparable Harm ,
Medicare ,
Medicare Claims Appeals Process ,
Motion for Reconsideration ,
OMHA ,
Overpayment ,
Physician Medicare Reimbursements ,
Recoupment ,
Redeterminations ,
TRO
August 24, 2018 marked a busy day for the U.S. Department of Health & Human Services' (HHS) self-designated "Regulatory Sprint to Coordinated Care," an initiative aimed at dismantling the regulatory barriers to providers...more
9/7/2018
/ Alternative Payment Models (APM) ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
CMMI ,
Comment Period ,
Commercial Reasonableness ,
Cost-Sharing ,
Cybersecurity ,
Data-Sharing ,
Department of Health and Human Services (HHS) ,
EHR ,
Fraud and Abuse ,
Health Care Providers ,
Hospitals ,
Incentives ,
Medicare Shared Savings Program ,
OIG ,
Physicians ,
Public Comment ,
Request For Information ,
Safe Harbors ,
Stark Law ,
Telehealth ,
Value-Based Care ,
Waivers