False Claims Act Insights - An FCA Perspective on Artificial Intelligence in the Healthcare Industry
The State of Healthcare Enforcement
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
What’s in Your Operating Agreement? Legal Tips for Healthcare Providers
10 For 10: Top Compliance Stories For the Week Ending, July 26, 2025
Key Discovery Points: Don’t Get Caught with Your Hand in the Production Cookie Jar
Work this Way: An Employment Law Video Podcast | Episode 50: Creating a Competitive Advantage Through Employee Benefits with Connor Shaw of Gallagher
False Claims Act Insights - Will Recent Leadership Changes Lead to FCA Enforcement Policy Changes?
Podcast: Addressing Patient Complaints About Privacy Violations
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney Severance of Operation Upright
Podcast - Navigating the New Landscape of Private Equity in Healthcare
Taking the Pulse: A Health Care and Life Sciences Video Podcast | Episode 235: Revolutionizing Cancer Care with Eric Perrault of Kiyatec
Evolving AI Legislation: Federal Policies, Task Forces, and Proposed Laws — The Good Bot Podcast
CareYaya: A Revolutionary Approach to Elder Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
False Claims Act Insights - Trump DOJ Sharpens Its Focus on Healthcare Fraud
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care Video Podcast
Criminal Health Care Fraud Enforcement: Projections for 2025 and Beyond – Diagnosing Health Care Video Podcast
Healthcare Industry Segment-Specific Compliance Program Guidances (ICPGs)
On December 23, 2023, CMS issued its Final Rule, establishing new Clinical Laboratory Improvement Amendments (CLIA) regulations (the Final Rule). Several provisions only became effective December 28, 2024. CMS was driven to...more
Compared with other issues, healthcare enforcement during President-elect Donald Trump’s upcoming second term has received little attention. When he takes office again on January 20, should industry actors like pharmaceutical...more
On March 22, 2023, the Centers for Medicare & Medicaid Services (CMS) announced that it will begin sending electronic Clinical Laboratory Improvement Amendments (CLIA) certificates to those laboratories that opt on their CLIA...more
Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more
First Data Collection Period for Clinical Laboratories Is July 1, 2015 to December 31, 2015 - In the October 1, 2015 Federal Register, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule...more
Guest Post By: Perry Dimas, Senior Vice President and General Manager for Premier Source, part of AmerisourceBergen The 2015 Business of Personalized Medicine Summit was an inspiring day with talented professionals. One...more
On Friday, the Centers for Medicare & Medicaid Services (“CMS”) issued a long-awaited proposed rule that would drastically change the payment rates for clinical laboratory services beginning January 1, 2017 (the “Proposed...more
CMS Announces New SNF Payment – On August 27, 2015, CMS announced “a new funding opportunity” for SNFs that is intended “to reduce avoidable hospitalizations by funding higher-intensity interventions in nursing...more
On December 5, 2014, the Centers for Medicare & Medicaid Services (CMS) issued a final rule titled “Requirements for Medicare Incentive Reward Program and Provider Enrollment” (“the Rule”). The Rule implemented several...more
On Oct. 6, 2014, a final rule issued jointly by the Centers for Medicare & Medicaid Services (CMS), Centers for Disease Control and Prevention (CDC), and Office for Civil Rights (OCR) will require all HIPAA-covered labs...more
In the wake of a new Medicare reimbursement framework, FDA plans stricter regulation of some in vitro diagnostic devices. On July 31, 2014, the U.S. Food and Drug Administration (FDA; Agency) announced its intent to...more
Advances in medical technology have increased the use of diagnostic tests to guide therapeutic decisions for many diseases and conditions, especially in the context of personalized medicine. Citing the need to ensure that...more
Perhaps not coincidentally, immediately following the release of the Questionable Laboratory Payments Special Fraud Alert by the OIG, posted yesterday on the Med Law Blog, the OIG has followed up with Audit Report OIG –...more
Through two recently issued regulations, the Centers for Medicare and Medicaid Services have announced their intention to reform and improve Medicare policies addressing clinical diagnostic laboratory services. These...more
In a previous Payment Matters article, we described a new CMS policy under which, effective January 1, 2014, hospitals would no longer be permitted to bill Medicare separately for clinical laboratory tests for hospital...more
Yesterday the Centers for Medicare & Medicaid Services (CMS) finally published the long-awaited final rule amending the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the Health Insurance Portability and...more
Hospitals Lose Right to Bill Separately for Laboratory Tests for Outpatients - As part of its calendar year 2014 hospital outpatient prospective payment system (OPPS) policy changes, the Centers for Medicare & Medicaid...more
On the day before Thanksgiving and a little over one month after the end of the government shutdown, the Centers for Medicare & Medicaid Services (“CMS”) published a rule finalizing revisions to payment policies under the...more
On November 6, 2013, CMS announced that it plans to turn on claims processing edits (effective January 6, 2014) to deny Part B clinical laboratory and imaging, and DMEPOS, and Part A home health agency claims that fail...more
On July 8, 2013, the Centers for Medicare & Medicaid Services (CMS) released a pre-publication version of the 2014 Medicare Physician Fee Schedule and the 2014 Medicare Hospital Outpatient Prospective Payment System Notices...more