Latest Publications

Share:

OIG Increases Expectations for Compliance Officers in Its New Compliance Program Guidance – What Compliance Officers at...

On November 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued its anticipated General Compliance Program Guidance (“GCPG”) for the health care industry. The GCPG serves as a...more

DOJ Increases Scrutiny of Arrangements with EHR Vendors: What the ModMed Settlement Means for the Life Sciences Industry

On November 1, 2022, Modernizing Medicine, Inc. (“ModMed”), an electronic health record (“EHR”) technology vendor, entered into a settlement agreement with the Department of Justice (“DOJ”), agreeing to pay $45 million to...more

COVID-19 Health Care Fraud Enforcement on the Rise: What’s Ahead for the Life Sciences & Healthcare Industries

On April 20, 2022, the Department of Justice (“DOJ”) announced twenty-one (21) defendants were charged in nine (9) different districts related to $149 million in COVID-19-related false billing issues. $8 million in cash and...more

AdvaMed Updates Code of Ethics on Interactions with HCPs: What’s the Impact on MedTech?

On March 18, 2022, the Advanced Medical Technology Association (“AdvaMed”) announced revisions to its Code of Ethics on Interactions with Health Care Professionals (“Code”). The revised Code will take effect June 1, 2022. ...more

Revised PhRMA Code Provides Stricter Controls on HCP Speaker Programs

The Revised PhRMA Code Takes Effect January 1, 2022 - On August 6, 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) released highly anticipated revisions to its Code on Interactions with Health Care...more

Implementation of Final Rule Excluding PBM Rebates from Discount Safe Harbor Delayed Until 2023

Pharmaceutical Care Management Association (“PCMA”) lawsuit results in delayed implementation of Final Rule while Biden Administration review is ongoing - Pursuant to a Court Order, implementation of the U.S. Dept. Health...more

CMS Proposes New DMEPOS Coverage Policies and Payment Rates, and Seeks to Codify HCPCS Application, Benefit Category and Payment...

On November 4, 2020, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule (the Proposed Rule) outlining proposals for the coverage and payment for durable medical equipment, prosthetics, orthotics, and...more

HHS Finalizes Rule Challenging Drug Manufacturer Rebates to PBMs and Payors

Final Rule Closely Resembles Previously Withdrawn 2019 Proposed Rule - INTRODUCTION - On November 20, 2020, as part of a release of several drug pricing rules, the U.S. Department of Health and Human Services (“HHS”)...more

Are Pharma Speaker Programs Facing an Existential Crisis?

Exploring the Implications of HHS-OIG’s Special Fraud Alert and Groundbreaking Novartis CIA Requirements on Compliance Program Policies and Controls that Govern Speaker Programs - A Special Fraud Alert issued by the U.S....more

France – Thresholds for Prior Authorization of Agreements with Healthcare Professionals and for Benefits of Low Value are Finally...

The two arrêtés [orders] setting thresholds for transfers of value from pharmaceutical and medical devices companies to healthcare professionals, institutions, and other actors of the healthcare sectors (Healthcare...more

France - New notification and authorization regime for exemptions from benefits/payments to the healthcare sector will enter into...

In France, Ordinance No 2017-49 of 19 January 2017 significantly modified the rules governing payments from life sciences companies to the healthcare sector. After more than three years, on June 15, 2020, Decree No 2020-730...more

New Risks, New Rewards, New Exposure

Value-Based Purchasing, Multiple Best Prices, Expanded Alternative URA, and other MDRP Drug Pricing Changes in Proposed Rule - On June 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a major...more

FDA Issues Proposed Rule and Draft Guidance on Drug Importation

In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more

HHS Issues Proposed Rule to Update Anti-Kickback Statute Safe Harbors – What Does it Mean for Life Sciences Companies?

HHS’ Proposals are Designed to Promote Patient Care Coordination, Management, and Efficiencies, and Include Several Points of Interest for Pharmaceutical and Medical Device Manufacturers - In today’s Federal Register, the...more

CMS Issues Final Rule Requiring the Disclosure of Drug List Prices in Direct-to-Consumer Television Ads

The Final Rule Requires Manufacturers to Disclose List Prices of Prescription Drugs and Biological Products in Television Advertisements - On May 8, 2019, the U.S. Department of Health and Human Services (HHS or the...more

Congress Acts to Eliminate MDRP Misclassification

President Trump on Thursday signed into law the most extensive set of amendments to the Medicaid Drug Rebate Program statute since the Affordable Care Act in 2010. The new law addresses the perception that drug manufacturers...more

HHS Proposes Rule Challenging Drug Manufacturer Rebates to PBMs and Payors

The Proposed Rule Would Make Clear that the Anti-Kickback Statute’s Discount Safe Harbor Does Not Protect Manufacturer Rebates to PBMs or Payors, But Would Create New Safe Harbors for Rebates Passed Through to the...more

AdvaMed Updates Code of Ethics on Interactions with U.S. Health Care Professionals

The Updated Code Includes Several New Topics and Additional Guidelines on Existing Topics - The Advanced Medical Technology Association (AdvaMed) published in late December 2018 an updated version of its widely-adopted...more

CMS Announces that Current DMEPOS CBP Contracts Will Not Be Renewed or Extended for January 2019, and Proposes Changes to the...

On July 11, 2018, CMS announced that the process for recompeting contracts with suppliers currently in effect under the durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) Competitive Bidding Program (CBP)...more

Trump Administration Releases 'Blueprint' to Address Drug Prices

On Friday, May 11, the Trump Administration released a 39-page “Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs” (“Blueprint”). The Blueprint raises in very broad strokes potential Administration strategies to...more

FDA Issues Final Rule and Guidance Creating New Standards for the Acceptance of Data Obtained from Clinical Investigations...

On February 21, 2018, the Food and Drug Administration (FDA) issued a final rule amending the Agency’s regulations on acceptance of data from clinical investigations form medical devices. The final rule amends requirements...more

New York Institutes New Medicaid Drug Price Control Measures

State Budget Includes Medicaid Drug Expenditure Cap - On April 20, 2017, New York Governor Andrew Cuomo signed into law certain cost-control measures that attempt to cap the state’s Medicaid drug spending, making New York...more

HHS Issues Final Rule that Substantially Revises the Federal Policy for the Protection of Human Subjects

On January 19, 2017, the Department of Health and Human Services (HHS) and fifteen other Federal departments and agencies published a final rule that extensively revises and modernizes the Federal Policy for the Protection of...more

29 Results
 / 
View per page
Page: of 2

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide