With the change of administrations typically comes a flurry of activity across all government agencies, and the same can be expected with the official start of the Biden Administration now well underway. What should...more
2/1/2021
/ Biden Administration ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Final Rules ,
Government Agencies ,
Healthcare Fraud ,
Healthcare Reform ,
Medicare ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Proposed Rules ,
Reimbursements
Most Favored Nations Model will alter how certain Medicare Part B drugs are reimbursed.
The Centers for Medicare & Medicaid Services (CMS) released an advance copy of an interim final rule with a comment period announcing...more
Final Rule largely tracks prior proposal to make significant changes to the Discount Safe Harbor and other regulatory safe harbors to the Federal Anti-Kickback Statute.
The Department of Health and Human Services Office of...more
The Department of Health and Human Services Office of the Inspector General (OIG) published a Special Fraud Alert on November 16, 2020 (the Alert) regarding a common practice within the pharmaceutical and medical device...more
11/18/2020
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Fraud ,
Health Care Providers ,
Medicaid ,
Medical Devices ,
Medicare ,
OIG ,
Pharmaceutical Industry ,
Remuneration ,
Speaker Programs ,
TRICARE
Three organizations serving primarily HIV and AIDS patients and who each are also considered “Covered Entities” under the 340B Drug Pricing Program (the Plaintiffs) filed a lawsuit against Department of Health and Human...more
10/16/2020
/ Administrative Procedure Act ,
AIDS ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Dispute Resolution ,
Drug Pricing ,
HIV ,
HRSA ,
New Regulations ,
Pharmaceutical Industry ,
Pharmacies ,
Section 340B
The White House released a new Executive Order on September 13, 2020, related to drug prices titled “Lowering Drug Prices by Putting America First” the September Order), whose stated purpose is to address reimbursement for...more
9/17/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Medicare Part B ,
Medicare Part D ,
Medicare Prescription Drug Improvement and Modernization Act (MMA) ,
Mitigation ,
Prescription Drugs ,
Secretary of HHS ,
Trump Administration
In a move with far reaching implications for the health care industry, the Department of Health and Human Services (HHS) recently released a proposed rule that would codify into regulation specific requirements that it and...more
CMS is soliciting comments on whether future payments for devices that may have been impacted by the COVID-19 PHE should be adjusted.
The Centers for Medicare & Medicaid Services (CMS) issued its annual proposed rule related...more
8/24/2020
/ 21st Century Cures Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
HCPCS ,
HOPPS ,
Interim Final Rules (IFR) ,
Manufacturers ,
Medical Devices ,
Medicare Part B ,
Medicare Part D ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Pharmacist ,
Physician Fee Schedule ,
Proposed Rules ,
Public Health Emergency ,
Social Security Act
Members of the industry should be on the lookout for proposed rules related to this Order and take advantage of all public comment periods.
The White House issued an executive order “Ensuring Essential Medicines, Medical...more
The White House released three Executive Orders on July 24, 2020 setting forth policies that the Administration believes will “deliver lower prescription drug prices to American patients.” A fourth Executive Order tying...more
7/31/2020
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
FQHC ,
Medicare Part B ,
Medicare Part D ,
OIG ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Public Safety ,
Safe Harbors
The Centers for Medicare & Medicaid Services (CMS) published a Proposed Rule on June 19, 2020 (the Proposed Rule) which, among other things, suggests updates to Medicaid policies and practices related to drug pricing and...more
A HHS Final Rule for Exchange plans states that coupons and copay cards offered directly by drug manufacturers can be counted towards a patient’s annual cost-sharing limit.
The Department of Health and Human Services (HHS)...more
In what has been considered a huge win for community pharmacists, the Department of Health and Human Services (HHS) Office of the General Counsel (OGC) issued an Advisory Opinion on May 19, 2020.
The Advisory...more
On March 11, 2020, the Centers for Medicare & Medicaid Services (CMS) announced a voluntary model within the Medicare Part D program that would allow certain Part D plans to cap Medicare beneficiaries’ out-of-pocket costs for...more
On March 10, 2020 the Centers for Medicare & Medicaid Services released a memo to Medicare Advantage Organizations and Part D Sponsors to inform them of their obligations and permissible flexibilities related to disasters and...more
The Centers for Medicare & Medicaid Services (CMS) published the Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program,...more
3/9/2020
/ Call Letter ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Cost-Sharing ,
Health Care Providers ,
Medicare ,
Medicare Advantage ,
Medicare Part D ,
Pharmacies ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
Reporting Requirements
Whistleblower Collects on Cybersecurity FCA Case -
On July 31, 2019, Cisco Systems agreed to pay $8.6 million in civil damages to settle claims that it sold video surveillance technology with known security flaws to several...more
Telemarketing Business Agrees to Pay $2.5 Million to Settle FCA Allegations of Telemedicine Scheme -
The US Attorney’s Office for the Middle District of Florida, in collaboration with the US Attorney’s Office for the...more
8/12/2019
/ Department of Justice (DOJ) ,
Dismissals ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Indictments ,
Kickbacks ,
Medicare ,
Physicians ,
Settlement ,
Telemarketing
Patient Recruiter Convicted in $1.3 Million Kickback Conspiracy Scheme -
After a six-day trial, a federal jury in Detroit found a patient recruiter guilty of one count of conspiracy to pay and receive health care...more
8/5/2019
/ Aiding and Abetting ,
Blue Book ,
Civil Monetary Penalty ,
Criminal Conspiracy ,
Criminal Convictions ,
Criminal Prosecution ,
False Claims Act (FCA) ,
Federal Contractors ,
Foreclosure Sales ,
Health Care Providers ,
Healthcare Fraud ,
Home Health Agencies ,
Kickbacks ,
Medicare ,
Mortgage Lenders ,
Public Contracts ,
Settlement ,
Wire Fraud
On July 29, 2019, the Centers for Medicare & Medicaid Services (CMS) released its annual proposed update to the hospital outpatient prospective payment system (Proposed Rule)....more
Podiatrist Sentenced to Prison for Fraudulent Billing Scheme -
On July 19, 2019, a New York podiatrist was sentenced to 366 days in prison, assessed a $50,000 fine, ordered to pay $869,651 in restitution and forfeit...more
7/29/2019
/ Anti-Kickback Statute ,
Criminal Convictions ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medicaid ,
Medical Devices ,
Medicare ,
Pharmacies ,
Physicians ,
Prescription Drugs
DOJ News & Litigation Updates -
ITT Cannon to Pay $11 Million to Settle False Claims Allegations -
ITT Cannon (ITT), a division of ITT Inc., has agreed to pay $11 million to settle whistleblower claims that it supplied...more
7/22/2019
/ Banks ,
Bond Traders ,
Civil Monetary Penalty ,
CMBS ,
Corporate Integrity Agreement ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Contractors ,
Hospitals ,
Misrepresentation ,
RMBS ,
Securities and Exchange Commission (SEC) ,
Settlement ,
Whistleblower Awards ,
Whistleblowers
DOJ News -
Inpatient Rehabilitation Company Agrees to Pay $48 Million to Resolve FCA Allegations -
DOJ announced that Encompass Health Corporation (f/k/a HealthSouth Corporation), the nation’s largest operator of...more
7/17/2019
/ Criminal Conspiracy ,
Department of Justice (DOJ) ,
Disgorgement ,
False Claims Act (FCA) ,
Guilty Pleas ,
Health Care Providers ,
Healthcare Facilities ,
Insider Trading ,
Laboratories ,
Medicare ,
Most-Favored Nations ,
OIG ,
Permanent Injunctions ,
Pre-Judgment Interest ,
Qui Tam ,
Relators ,
Securities and Exchange Commission (SEC) ,
Securities Fraud ,
Securities Violations ,
Settlement ,
State False Claims Acts ,
Wire Fraud
On July 8, 2019, in Merck & Co., Inc. v. United States Department of Health and Human Services, the US District Court for the District of Columbia invalidated a final rule pursuant to which pharmaceutical manufacturers would...more