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Manufacturers Should Carefully Evaluate OIG’s Approval of Medicare Cost Sharing Subsidies in Clinical Trials

At the end of last year, the US Department of Health and Human Services Office of Inspector General (OIG) issued an Advisory Opinion (AO 23-11, the Opinion) in which OIG approved an arrangement where a medical device...more

Medicare Part B Enrollees Will Save on 64 Newly Selected Drugs Under Inflation Rebate Program

Medicare Part B enrollees as of July 1, 2024 will experience savings on coinsurance for 64 drugs selected by the Biden administration. Pursuant to the Inflation Reduction Act and its Medicare Prescription Drug Inflation...more

State-Mandated Upper Payment Limits: Maryland PDAB Evaluates 6 Drugs for Affordability

Pharmaceutical drug pricing and reimbursement continues to make headlines nationwide. In a recent development, Maryland’s Prescription Drug Affordability Board (PDAB) finalized its list of selected drugs for affordability...more

Mass. USAO Hints at Healthcare Fraud Enforcement Focus in Rare Disease Space at White Collar Crime Conference

The Boston Bar Association hosted its fifth annual White Collar Crime Conference on May 2, 2024, featuring prosecutors from the US Attorney’s Office for the District of Massachusetts (the Office) and the Office of the...more

California’s Revised Prescription Drug Price Transparency Regulations Effective April 1

Effective April 1, 2024, California will expand its existing prescription drug price transparency requirements by enacting legislation to amend and clarify requirements on wholesale acquisition cost increase reporting and...more

Once Again #1: Health Care Fraud Leads DOJ False Claims Act Recoveries in 2024

The US Department of Justice (DOJ) Civil Division released its annual fraud statistics on February 22, highlighted by False Claims Act (FCA) settlements and judgments exceeding $2.68 billion in fiscal year 2023. DOJ released...more

New York Enacts Prescription Drug Price Transparency Bill

New York expanded its existing efforts at monitoring and understanding prescription drug prices by enacting legislation addressing prescription drug price transparency. Effective June 19, 2024, S.599-A/A.1707 amends the New...more

Trending in 2024: What Does the HCFAC Report Signal About Federal Enforcement Mechanisms?

The Health Care Fraud and Abuse Control Program (HCFAC), an annual report jointly issued by the US Department of Justice (DOJ) and Department of Health and Human Services (HHS), can be helpful in predicting DOJ and HHS...more

Florida Healthcare Director Charged in Fraud Case Against CMS

Continuing its recent slate of high-profile indictments, convictions, and plea agreements involving healthcare executives who have violated federal healthcare laws, the US Department of Justice (DOJ) recently announced...more

Get Ready, Set, and Go to the JPM Healthcare Conference

As Prescribed and Health Law Scan subscribers know that the end of the holidays means the annual J.P. Morgan (JPM) Healthcare Conference is only days away. To make the most of the 2024 conference and conference-adjacent...more

DOJ Offers Encouragement for Organizations Looking Into M&A Deals

At a recent Food and Drug Law Institute (FDLI) conference, Arun Rao, Deputy Assistant Attorney General for the US Department of Justice’s (DOJ’s) Consumer Protection Branch (CPB), reiterated DOJ’s “Safe Harbor Policy” with...more

Connecticut Rolls Out Legislation on Pharmaceutical Sales Reps, Costly Outpatient Drugs

Connecticut will bolster its existing prescription drug reporting and transparency regime with new requirements on pharmaceutical sales representative registration and updates to existing manufacturer transparency reporting,...more

Texas Attorney Convicted of Conspiracy with Clients to Commit Healthcare Fraud

n the second blog post of our series on healthcare chief compliance officers and lawyers accused of “going bad,” we discuss Texas attorney Peter J. Bennett (licensed since 2007) who was charged in the Eastern District of...more

New Jersey Latest to Join States Signing Drug Price Transparency Reporting Measures into Law

Following in the footsteps of other states, New Jersey’s state legislature has recently signed into law three bills for containing prescription drug costs. One bill—Senate Bill 1615—is likely to have a particularly sweeping...more

False Claims Act Breakups Are Harder to Do in the District of Massachusetts

As we at Morgan Lewis pride ourselves on excellent client service, we feel it is our duty to provide critical dispatches from the romantic world of healthcare fraud. Specifically, we want to highlight developments in the...more

State Drug Price Transparency Reporting Legislative Update: Florida Joins the Bandwagon and Minnesota Adds Onerous New...

As their 2023 sessions draw to a close, mostly part-time state legislatures have continued their efforts throughout the spring to promote drug price transparency across the prescription drug supply chain. Notable among these...more

Chief Compliance Officer Convicted in Healthcare Fraud Case

The US Department of Justice (DOJ) announced on June 8, 2023 that Steven King, a compliance executive of pharmacy holding company A1C Holdings LLC, was convicted of defrauding Medicare out of more than $50 million in a scheme...more

US Supreme Court Affirms Easy Government Dismissal Standard in Declined Qui Tam Cases, But Renews Constitutionality Debate

The US Supreme Court’s decision in United States ex rel. Polansky v. Executive Health Resources ­confirms the relative ease by which the US government can exercise its dismissal authority under False Claims Act (FCA) Section...more

White Collar Crime Conference Talks Healthcare Fraud

The Boston Bar Association held its annual White Collar Crime Conference on May 4, 2023, featuring lawyers from the defense and plaintiffs’ bar and current and former prosecutors from the US Attorney’s Office for the District...more

How the End of the PHE Will Impact the Healthcare Industry

The Biden administration announced on January 30, 2023 that the COVID-19 Public Health Emergency (PHE) would officially end on May 11, 2023. The PHE declaration, which first was issued by the Secretary of the US Department of...more

DOJs False Claims Act 2022 Year in Review Shows Significantly Lower Recoveries in the Healthcare Industry

The US Department of Justice’s (DOJ’s) Civil Division released its annual fraud statistics on February 7, covering fiscal year 2022. Settlements and judgments under the False Claims Act (FCA) exceeded $2.2 billion in the...more

CMS’s Delayed Final Rule on the FFS Adjuster Gets Delayed . . . Again

The Centers for Medicare & Medicaid Services (CMS) delayed the publication of the final rule on the use of extrapolation and the application of a fee-for-service adjuster (FFS Adjuster) in risk adjustment data validation...more

Inflation Reduction Act: Initial Takeaways for Green Technology, Taxes, and Healthcare

The Inflation Reduction Act of 2022, passed by the US Senate on August 7, 2022, will dramatically affect a range of climate change, healthcare, prescription drug pricing, and tax matters. With an investment of more than $400...more

November Fast Break Recap: Compliance Topics for Healthcare Professionals Interacting with Pharma/Device Manufacturers

Last month, we had an engaging Fast Break session covering compliance topics regarding healthcare professionals’ relationships with pharmaceutical and medical device manufacturers. We were joined by Terrence Burek, senior...more

CMS PFS Emphasizes Health Equity via Payment Policy Updates

The Centers for Medicare & Medicaid Services released its CY 2022 Physician Fee Schedule final rule on November 2 reflecting the Biden-Harris administration’s goal of increasing access to and quality of care and reducing...more

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