The Office of Inspector General for the Department of Health and Human Services (OIG) recently published an Advisory Opinion in which it concluded that the provision of free genetic testing and counseling services by a...more
Before the COVID-19 pandemic derailed even the best-laid plans, the Trump Administration and Congress were focused on a different public health issue: drug pricing. For years, President Trump has targeted “Big Pharma” as...more
On June 26, the Department of Health and Human Services Office of the Inspector General (OIG) issued Advisory Opinion No. 20-03 approving the payment by a discount medical plan organization (DMPO) of a five dollar ($5.00) fee...more
The Centers for Medicare & Medicaid Services (CMS) has taken another step to further the adoption of value-based purchasing within the health care industry. (Readers may recall the Department of Health & Human Services’ two...more
6/26/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Medicaid ,
OIG ,
Proposed Regulation ,
Proposed Rules ,
Safe Harbors ,
Trump Administration ,
Value-Based Purchasing
This post is the third installment of our blog series on recent proposed rules from the Department of Health & Human Services (HHS) that, if finalized, would implement major changes to the Anti-Kickback Statute (AKS) and the...more
10/23/2019
/ Anti-Kickback Statute ,
Beneficiary Inducement ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Healthcare Reform ,
OIG ,
Personal Services ,
Proposed Rules ,
Regulatory Requirements ,
Safe Harbors ,
Stark Law ,
Value-Based Care ,
Warranties
On October 17, 2019, the Department of Health & Human Services (HHS) published two proposed rules (one by the Office of Inspector General (OIG) and one by the Centers for Medicare & Medicaid Services (CMS)) that, if...more
10/22/2019
/ 21st Century Cures Act ,
Anti-Kickback Statute ,
Beneficiary Inducement ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Comment Period ,
Cybersecurity ,
EHR ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Reform ,
OIG ,
Popular ,
Proposed Rules ,
Public Comment ,
Safe Harbors ,
Stark Law ,
Value-Based Care
As we reported last week, the Department of Health & Human Services (HHS) recently issued two proposed rules (one by the Office of Inspector General (OIG) and one by the Centers for Medicare & Medicaid Services (CMS)) that,...more
10/16/2019
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Hospitals ,
OIG ,
Physicians ,
Proposed Amendments ,
Proposed Rules ,
Regulatory Oversight ,
Safe Harbors ,
Stark Law ,
Value-Based Care
On October 9, 2019, the Department of Health & Human Services (HHS) announced significant changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (known as the Stark Law) through proposed rules issued...more
10/11/2019
/ Anti-Kickback Statute ,
Beneficiary Inducement ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Exceptions ,
Health Care Providers ,
Healthcare Reform ,
Hospitals ,
OIG ,
Physicians ,
Proposed Rules ,
Public Comment ,
Regulatory Requirements ,
Safe Harbors ,
Stark Law ,
Value-Based Care
Senators Chuck Grassley (R-IA) and Ron Wyden (D-OR), Chairman and Ranking Member (respectively) of the Senate Finance Committee, have fired the latest shot in Congress’s ongoing battle against high drug prices. Last week, the...more
In an unexpected turn of events, the Trump administration has apparently reversed course and has withdrawn the proposed rule that would have amended the discount safe harbor under the Anti-Kickback Statute to eliminate...more
7/12/2019
/ Anti-Kickback Statute ,
Drug Pricing ,
Executive Orders ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Price Transparency ,
Proposed Rules ,
Safe Harbors ,
Secretary of HHS ,
Trump Administration
On January 31, 2019, the U.S. Department of Health & Human Services (HHS) issued a proposed rule that would amend the discount safe harbor under the Anti-Kickback Statute (AKS) to eliminate protection for certain drug...more
2/5/2019
/ Anti-Kickback Statute ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
Safe Harbors
In May, the Trump Administration announced its Blueprint to Lower Drug Prices and HHS Secretary Azar issued a Request for Information seeking comments from interested parties “to help shape future policy development and...more
7/24/2018
/ Anti-Kickback Statute ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Secretary of HHS ,
Trump Administration
As the healthcare industry moves towards value-based purchasing, pay-for-performance, and other payment reform models, industry leaders have identified federal fraud and abuse laws as a barrier to full implementation of such...more
3/16/2017
/ ACOs ,
Anti-Kickback Statute ,
Civil Monetary Penalty ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Hospitals ,
Medical Devices ,
Medicare Shared Savings Program ,
OIG ,
Pharmaceutical Industry ,
Physicians ,
Safe Harbors ,
Stark Law ,
Value-Based Care
In recent years, copayment coupon programs have become standard promotional practices for both large and small pharmaceutical manufacturers. Copayment coupons are typically offered to commercially insured patients in order to...more
10/21/2014
/ Affordable Care Act ,
Ambulance Providers ,
Anti-Kickback Statute ,
CMP Law ,
Gainsharing ,
Hospitals ,
OIG ,
Pharmacies ,
Physicians ,
Proposed Regulation ,
Safe Harbors
Fridays never seem to be slow in the health care regulatory world. On Friday, October 3rd, the HHS Office of the Inspector General (OIG) issued a highly anticipated proposed rule (the Proposed Rule) that provides amendments...more
On the heels of HHS’s recent announcement that qualified health plans (QHPs) purchased through the Affordable Care Act (ACA) insurance exchanges are not “federal health care programs” for purposes of the federal anti-kickback...more
In a surprising move late last week, HHS Secretary Kathleen Sebelius announced that qualified health plans (QHPs) purchased through the Affordable Care Act’s (ACA) insurance exchanges are not “federal health care programs”...more
In Advisory Opinion 12-21, the OIG concluded that a Federally qualified health center’s offer of grocery store gift cards to capitated managed care patients would not constitute grounds for the imposition of sanctions under...more
In OIG Advisory Opinion 12-20, the OIG determined that a proposed arrangement (the “Proposed Arrangement”) by a hospital (the “Requestor”) would not constitute grounds for the imposition of sanctions under the Anti-Kickback...more