There are currently six states with active Prescription Drug Affordability Boards (PDABs) — Colorado, Maryland, Washington, Oregon, New Hampshire, and Minnesota....more
In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General (OIG), manufacturers have contested the OIG’s...more
Disputes between 340B Drug Pricing Program-covered entities and the drug manufacturers required to sell outpatient drugs to those entities at discounted prices will be governed by an alternative dispute resolution (ADR)...more
5/15/2024
/ Affordable Care Act ,
Conflicts of Interest ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Dispute Resolution ,
Federal Rules of Civil Procedure ,
Federal Rules of Evidence ,
Final Rules ,
HRSA ,
Manufacturers ,
Office of Pharmacy Affairs (OPA) ,
Prescription Drugs ,
Section 340B
Earlier this month, the US District Court for the District of Oregon issued a declaratory judgment invalidating a key component of the Oregon Drug Price Transparency Program.
The Oregon Drug Price Transparency Program was...more
It is the annual summer pastime for the pharmaceutical community. Time to review the Centers for Medicare & Medicaid Services (CMS) release of the 2024 proposed Hospital Outpatient Prospective Payment System (HOPPS) and...more
The Centers for Medicare & Medicaid Services (CMS) and the US Department of Health and Human Services Office of Inspector General (OIG) continue to issue guidance regarding the implementation of the drug pricing provisions of...more
After many years of policy debate and attempts at proposed legislation, some of the most meaningful changes to the ways in which Medicare pays for prescription drugs – and the obligations of manufacturers selling drugs to...more
8/23/2022
/ Abbreviated New Drug Application (ANDA) ,
American Rescue Plan Act of 2021 ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Final Rules ,
Inflation Reduction Act (IRA) ,
Medicaid Drug Rebate Program ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
New Legislation ,
Prescription Drugs ,
Section 340B
The Centers for Medicare & Medicaid Services (CMS) issued its annual proposed rule related to the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems for 2023 (the HOPPS Proposed Rule) on...more
8/3/2022
/ American Hospital Association et al v Becerra Secretary Of Health And Human Services et al ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
HOPPS ,
Manufacturers ,
Payment Systems ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
SCOTUS ,
Supply Chain
The Pharmaceutical Research and Manufacturers of America (PhRMA) – a leading lobbying and advocacy group for drug manufacturers – has released an updated version of its “Code on Interactions with Health Care Professionals”...more
The United States Supreme Court has agreed to hear a case that has a direct impact on the 340B Drug Discount Program (the 340B Program) and how Medicare will reimburse hospitals for dispensing of 340B covered drugs, as well...more
In July 2020, the Trump Administration issued an Executive Order (the EO) directing the Secretary of the Department of Health and Human Services (HHS) to take certain actions and finalize rulemakings designed to “support the...more
6/14/2021
/ Biden Administration ,
Canada ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Motion to Dismiss ,
Pharmaceutical Industry ,
Prescription Drugs ,
Rulemaking Process ,
Secretary of HHS ,
Standing ,
Subject Matter Jurisdiction
Similar to the laws of several other states, the North Dakota law contains three main disclosure requirements that apply to “drug manufacturers” -
The Governor of North Dakota signed House Bill 1032 into law on April 27,...more
Texas Health and Human Services announced that beginning April 1, 2021, drug manufacturers who wish for their products to be added to the Texas Drug Code Index (the Texas Medicaid formulary) must create an electronic account...more
The American Rescue Plan Act of 2021, signed into law by President Biden on March 11, 2021, is a $1.9 trillion aid package that provides assistance to businesses and individuals experiencing financial hardship due to...more
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
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
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
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
In the DOJ’s first-ever criminal action against an electronic health records vendor, San Francisco-based Practice Fusion Inc. agreed to pay $145 million to resolve allegations that it received kickbacks from pharmaceutical...more
2/3/2020
/ Anti-Kickback Statute ,
Criminal Penalties ,
Deferred Prosecution Agreements ,
Department of Justice (DOJ) ,
Electronic Medical Records ,
False Billing ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Information Technologies ,
Healthcare Fraud ,
Investigations ,
Kickbacks ,
Opioid ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Qui Tam ,
Software ,
Whistleblowers
Omnicare and CVS Face Fraudulent Billing Lawsuit -
On Tuesday, the US Attorney’s Office for the Southern District of New York announced a False Claims Act lawsuit against Omnicare, Inc. and its parent company, CVS Health...more
12/20/2019
/ CVS ,
Department of Justice (DOJ) ,
Dismissals ,
False Claims Act (FCA) ,
Government Investigations ,
Medicaid ,
Medicare ,
Medicare Part D ,
Omnicare ,
Pharmacies ,
Prescription Drugs ,
Rite Aid ,
State Attorneys General ,
TRICARE ,
Whistleblowers
Headlines that Matter for Companies and Executives in Regulated Industries -
Kentucky Hospital Agrees to Pay $10 Million to Resolve False Claims Act Allegations -
Jewish Hospital & St. Mary’s Healthcare Inc. d/b/a...more
11/25/2019
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Compounding ,
Drug Testing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Hospitals ,
Laboratories ,
Medicaid ,
Medicare ,
Pharmacies ,
Prescription Drugs ,
Settlement
DOJ Issues Guidance on Ability-to-Pay in False Claims Act Cases -
On October 8, 2019, Assistant Attorney General Brian Benczkowski announced new guidance for federal prosecutors evaluating whether a corporation is unable...more
10/21/2019
/ Corporate Criminal Fines ,
Corporate Misconduct ,
Criminal Investigations ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Sentencing Guidelines ,
Healthcare Facilities ,
Healthcare Fraud ,
Kickbacks ,
Medicare ,
New Guidance ,
Prescription Drugs
Late Friday, September 27, 2019, President Trump signed the Fair and Accurate Medicaid Pricing Act into law as part of the Continuing Appropriations Act....more