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Investigations Newsletter: Chicago Laboratory Owner Charged with Defrauding Medicare in $60 Million COVID-19 Test Kit Scheme

Chicago Laboratory Owner Charged with Defrauding Medicare in $60 Million COVID-19 Test Kit Scheme - The Chicago-based owner of two laboratories, Zoom Labs Inc. and Western Labs Co., has been charged with health care fraud...more

Investigations Newsletter: District Court Declines to Stay Case Pending Resolution of FCA Causation Standard Issue Before Court of...

District Court Declines to Stay Case Pending Resolution of FCA Causation Standard Issue Before Court of Appeals - Earlier this week, a Massachusetts federal judge denied a motion to stay proceedings filed by Medtronic,...more

Health Care Providers Navigate Fallout of Major Cyberattack on Change Healthcare

Change Healthcare, an affiliate of Optum and UnitedHealth Group, processes more than 15 billion health care transactions annually and touches one of every three patient records. On February 21, Change disconnected its...more

Access to Mifepristone Hangs in the Balance

As those in the reproductive health space scramble to keep up with the ever-changing landscape of mifepristone (Mifeprex) access, it seems that every party must have their say. The last three months have seen updates from...more

Modified REMS, Clarification on Mailing Drugs, and Movement in Texas Case Mark Significant Weeks in the Reproductive Health Legal...

With the approval of the modified mifepristone Risk Evaluation and Mitigation Strategy (REMS), it has been a momentous few weeks in the reproductive health legal space. Modification to the REMS for Mifepristone...more

New Challenge to Abortion Access Takes on FDA Drug Approvals

On November 18, 2022, a collection of organizations and providers that oppose abortion filed suit against the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS), seeking — among...more

DOJ Prosecutes Physician and Pharmaceutical Sales Representative for Criminal HIPAA Scheme

Most violations of the Health Information Portability and Accountability Act (HIPAA) are addressed through administrative enforcement action. But, in some circumstances of improper conduct affecting the privacy or security of...more

OIG Reports Indicate the Government's Interest in Balancing Ongoing Telehealth Access With Increased Oversight

A pair of reports recently issued by the US Department of Health and Human Services (HHS) Office of the Inspector General (OIG) highlight the important role telehealth services have played in ensuring access to medical...more

OIG Warns Health Care Practitioners About Fraud Schemes With Telemedicine Companies in Special Fraud Alert

On July 20, 2022, the HHS Office of Inspector General (OIG) issued a Special Fraud Alert cautioning physicians and other health care practitioners to use “heightened scrutiny” when entering into telemedicine arrangements that...more

Health Care Providers Take Note: New Surprise Billing Regulations Mandate Provision of “Good Faith Estimates” Uninsured and...

Beginning January 1, 2022, all state licensed or certified health care facilities and providers must follow extensive rules for providing a "good faith estimate" of health care charges to uninsured and self-pay patients prior...more

CMS’s 2022 Physician Fee Schedule Holds in Place Telehealth Physician Supervision Requirements 

Makes Permanent Telehealth Behavioral Health Rules - CMS published the 2022 Physician Fee Schedule Final Rule on November 2, 2021. The Rule keeps intact CMS’s temporary physician supervision requirements related to the...more

New Safe Harbors Offer Opportunities for Innovative Arrangements, Including Digital Health

Recent updates to the federal Anti-Kickback Statute give providers additional flexibility to enter into innovative arrangements, but before doing so, providers must ensure they understand the safe harbor requirements...more

New Stark Exception Provides Additional Flexibility for Limited Financial Arrangements With Physicians

As part of its recent rulemaking process, the Centers for Medicare and Medicaid Services (CMS) finalized a new exception to the Physician Self-Referral Law (the Stark Law) to protect arrangements where limited remuneration is...more

Congress’ Efforts To End Surprise Medical Bills - The Latest From Washington

Lawmakers remain in negotiations among the three key committees in the House of Representatives: Energy & Commerce, Ways & Means, and Education & Labor, along with the Senate Committee on Health, Education, Labor and Pensions...more

Congress Moves Forward on Legislation to End Surprise Medical Bills

The Senate Health, Education, Labor, and Pensions Committee recently voted to advance bipartisan legislation, called the Lower Health Care Costs Act (the Act), aimed at, among other things, curbing surprise medical bills. ...more

FTC Hosts ‘Health Check on COPAs: Assessing the Impact of Certificates of Public Advantage in Health Care Markets’

On June 18, 2019, the Federal Trade Commission (FTC) hosted a workshop to discuss and analyze the effects of Certificates of Public Advantage (COPAs) and Certificates of Need (CONs) on price and access to health care...more

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