Articles by Anthony
Texas Moves to Rein in Ketamine Therapy: And Other States are Likely Next
The regulatory environment surrounding ketamine therapy is entering a new phase of maturity and enforcement. Recently, the Texas M…

New Executive Order Signals Faster Psychedelic Drug Approvals--and Closer DEA Scrutiny
On Saturday, April 18, President Trump signed an executive order designed to accelerate federal drug approvals for psychedelic dru…

HLA’s Latest PBM Win Highlights the Dangers of Inventory Discrepancies
Inventory discrepancies are one of the first things PBMs look for during an audit. Even minor clerical errors like entering the in…

Clashing with Caremark: $45,000+ in Clawbacks Fully Reversed for Florida Pharmacy
Health Law Alliance helped n independent pharmacy in Florida reverse over $45,000 in clawbacks.

DOJ Targets Ketamine Clinics: Federal Charges Lead to Prison and Probation for Two Providers
The explosion in demand for ketamine-assisted psychotherapy (“KAP”) has garnered significant media attention over the past few yea…

Defeating Optum: How HLA Won Full Termination Reversals for 7 New York Pharmacies
Health Law Alliance successfully reversed pending terminations for 7 New York pharmacies. Read more about how our PBM audit team a…

Ketamine Marketing Risks for Mental Health Providers
Ketamine marketing is under increasing regulatory scrutiny, with providers facing risk over claims, off-label promotion, and patie…

Why PBMs are Investigating Provider-Patient Relationships: And What it Means for Your Pharmacy
PBMs are ramping up audit pressure in 2026, now targeting provider-patient relationships to justify recoupments and even network t…

From Prior Authorization to Network Termination: The PBM Audit Trend Independent Pharmacies Must Watch
PBMs are increasingly targeting pharmacies over their role in the prior authorization process, using vague allegations to justify…

Building a Regulatory Compliance Checklist for Ketamine Therapy Providers
Ketamine providers face growing regulatory scrutiny across prescribing, marketing, and care models. A focused compliance checklist…

Health Law Alliance Welcomes Compounding Expert Pharmacist-Attorney Dr. Martha Rumore as Of Counsel
Health Law Alliance adds powerhouse Pharmacist/Attorney Dr. Martha Rumore to their team of boutique healthcare attorneys.

Italian Gold Broker Criminally Charged in $86 Million Customs Duty and Tariff Evasion Scheme Released on Bail
Italian national Claudio Fogale was released from federal jail after his attorney, Anthony J. Mahajan, successfully argued that th…

What to Expect in a Wound Care Audit - And Why You Shouldn’t Go It Alone
In 2025, wound care audits have become a top enforcement priority for federal and private payors, leaving providers unprepared and…

DOJ Targets Florida Dermatology Practices’ Wound Care Coding
Earlier this year, the DOJ announced a settlement with Florida dermatology practices over allegations of false wound care claims s…

When a Wound Care Audit Hits, Call Counsel First: How Specialized Attorneys Protect Your Practice
Medicare is intensifying scrutiny of wound care, OIG’s work plan spotlights skin-substitutes and related services, while CMS’s CER…

Approaching the Telehealth Policy Cliff: Medicare Telehealth Flexibilities to Expire Next Week
Without further congressional action, COVID-19 era telehealth flexibilities are set to expire on September 30, 2025. Read more to…

OIG Doubles Down on Increased Oversight for RPM in New Report
On August 28, 2025, the US Department of Health and Human Services’ Office of the Inspector General published a report outlining b…

Standing Up for Pharmacies: How HLA Fought and Reversed Optum’s Termination of a New York Pharmacy
In a recent victory, our attorneys at Health Law Alliance achieved a full reversal of Optum’s termination of a New York pharmacy.…

Health Law Alliance Successfully Sues the DEA and its Administrator, Terrance Cole, in Federal Court to Lift Immediate Suspension Order
Health Law Alliance is proud to announce a major victory in federal court, where it successfully secured the immediate lifting of…

RPM Roundup: Compliance Insights from Recent Remote Patient Monitoring Settlements
Federal enforcement actions are increasingly focused on remote patient monitoring (RPM) services. In this article, we break down t…

Ketamine Clinics & Compounders Now the Focus of Increased DEA Enforcement
The DEA is increasingly targeting ketamine providers with record-keeping inspections and audits, making expert Medicare and DEA co…

HLA's Diana Yastrovskaya Featured on Live TV for PBM Expertise
The feature underscores HLA’s mission to elevate thought leadership within the healthcare space and provide trusted expertise on i…

9th Circuit’s Landmark EKRA Ruling: What Providers Should Know
On July 11, 2025, the 9th Circuit upheld a laboratory operator’s convictions for violating EKRA by paying marketing agents to misl…

Proposed HIPAA Security Rule Overhaul: What’s Changing - and Why Telehealth Providers Should Act Now
The proposed changes to the HIPAA Security Rule stand to have a significant impact on telehealth providers, as they aim to strengt…

OIG Issues Advisory Opinion 25-03, A Roadmap for Compliant Telehealth Staffing Models
On June 6, 2025, the US Department of Health and Human Services’ Office of the Inspector General issued Advisory Opinion 25-03, of…

HLA Wins Full Reversal of PBM Audit Findings for Maryland Pharmacy
Health Law Alliance achieved full reversal of final audit findings for a Maryland pharmacy, just one of numerous victories our att…

DOJ’s 2025 National Health Care Fraud Takedown: What it Means for Telehealth Providers
The DOJ’s 2025 National Health Care Fraud Takedown charged 324 people in schemes totaling $14 billion in intended losses, includin…

Telehealth Audit Season: OIG Found 7 Percent Error Rate in Pandemic-Era E/M Billing
A 2024 OIG study found that 7% of E/M services billed during the pandemic were noncompliant with Medicare billing requirements. We…

Balancing Patient Access and Privacy in Audio-Only Telehealth
Address the specific compliance and privacy challenges associated with audio-only telehealth services. This article will provide t…

10 Telehealth Fraud Red Flags (and How to Avoid Them)
Provide telehealth providers with a concise guide to recognizing and mitigating potential fraud risks. Each “red flag” will highli…

DOJ Files False Claims Lawsuit Against Nationwide Specialty Wound Care Provider
The U.S. Department of Justice has filed a civil action against Vohra Wound Physicians Management, alleging various schemes to sub…

Federal Indictment Against NJ Doctor Collapses in Stunning DOJ Reversal
Health Law Alliance secured a full dismissal of all federal charges against NJ urologist Dr. Mukaram Gazi, marking an unprecedente…

Sun Pharma RICO Lawsuit Exposes Bribery Conspiracy Involving Big Three Wholesalers
Health Law Alliance attorney Anthony Mahajan, a former federal prosecutor, analyzes Sun Pharma's RICO lawsuit against independent…

Understanding Subpoenas for Medical Records: Types, Issuers, and Legal Risks
Many healthcare providers face the challenge of dealing with subpoenas for medical records. These legal demands require careful ha…

How to Respond to an OIG Subpoena: Defense Strategies for Healthcare Providers
Receiving an OIG subpoena means your healthcare practice is under federal investigation, typically for healthcare fraud or regulat…

Provider Alert: New York Physician Indicted in Louisiana for Virtually Prescribing Abortion Medication
New York doctor indicted in Louisiana for prescribing abortion pills via telehealth, raising legal battles over state laws, shield…

DEA Announces Three New Rules Expanding Telehealth Access
This article outlines the details of the three new telehealth rules promulgated by the Drug Enforcement Agency (DEA) and their imp…

Remote Patient Monitoring: Know the Basics of Compliant Billing and Coding
In the article we outline the basics of RPM billing and coding, including which RPM services are billable by payor, the unique fra…

Cross-State Licensing in Telehealth: Challenges, Solutions, and Opportunities
Explore the complexities and barriers telehealth providers face when offering services across state lines. This article will provi…

PBM Audits: Proven Strategies, Practical Insights, and Expert Guidance
PBM audits extend beyond paperwork, assessing pharmacy operations, staff preparedness, SOPs, and compliance culture. Proactive str…

Navigating PBM Audits in 2025: A Guide for Pharmacies
Navigate 2025 PBM audits confidently: Key triggers, trends, and preparation tips to protect your pharmacy.

Mastering PBM Audit Documentation: Tips for Pharmacies
Dive deep into the documentation side of audits. PBMs often demand a mountain of paperwork, and missteps here can trigger penaltie…

Leveraging Technology to Stay Ahead of PBM Audits
How technology can transform audit readiness, making compliance less stressful.

Telehealth and Fraud Prevention: Protecting Your Practice
Address the increasing scrutiny telehealth providers face regarding potential fraud, waste, and abuse in virtual care. This articl…

Telehealth in 2025: Medicare Providers Get Temporary Relief, But Uncertainty Remains
The American Relief Act, 2025, temporarily extends key Medicare telehealth flexibilities through March 31, 2025, preserving access…

Telehealth in 2025: What Medicare Providers Should Know
During COVID-19, Medicare expanded telehealth access by waiving geographic restrictions, broadening provider eligibility, and cove…

Establishing and Documenting Patient-Provider Relationships in Telehealth
Actionable steps to properly establish, document, and maintain these relationships, minimizing risks and enhancing compliance.

Top 10 Telehealth Compliance Mistakes You Might Be Making Right Now (and How to Fix Them)
Top 10 list of common telehealth compliance mistakes, with practical advice on how to identify and correct each issue.

DEA and HHS Extend COVID-19 Telehealth Prescribing Flexibilities Through 2025
Discuss the DEA/HHS joint rule extending the prescribing flexibilities for controlled substances. Include: 1) an overview of the p…

Maximizing Reimbursement for Telehealth Services
Offer telehealth providers a practical guide to navigating billing and reimbursement challenges specific to virtual care. This art…

Common PBM Audit Triggers and How to Avoid Them
Guide independent pharmacies in recognizing and proactively managing specific behaviors and operational trends that commonly lead…

Navigating Informed Consent Requirements in Telehealth: A Provider’s Guide
We examine the complex requirements and risks associated with informed consent for telehealth providers. The article provides acti…

Understanding the Investigative Agencies in Healthcare
After the Department of Justice threatened to indict our client for involvement in an alleged $6M healthcare fraud, we stood firm…

Department of Justice Declines to Prosecute HLA Client for Alleged $6M Fraud
After the Department of Justice threatened to indict our client for involvement in an alleged $6M healthcare fraud, we stood firm…

Enforcement of Arbitration Clauses in PBM Network Agreements: A Guide for Pharmacy Owners
This article explains arbitration clauses in Pharmacy Benefit Manager (PBM) network agreements, outlining when these clauses can b…

HLA's Lawsuit Against Optum Achieves Return of Hundreds of Thousands of Dollars in Withheld Reimbursement
Health Law Alliance's lawsuit against Optum has resulted in the immediate release of hundreds of thousands of dollars in reimburse…

HLA Attorney Anthony Mahajan Wins Dismissal of False Claims Lawsuit Against Oncology Dispensing Practice
Health Law Alliance's Anthony Mahajan is pleased to announce the complete dismissal of a lawsuit brought on behalf of the federal…

HLA Files Emergency Texas Lawsuit Against Optum PBM Audit Termination
Health Law Alliance announces the filing of an emergency lawsuit in federal court for the Northern District of Texas, Dallas Divis…
FTC Issues Interim Report Condemning Anticompetitive PBM Practices
The top Pharmacy Benefit Managers (PBMs) are condemned by the FTC for manipulating the healthcare system to generate significant p…

Seized Ozempic Shipments Highlight Rising Demand and Safety Concerns
Ozempic, a well-known medication for type 2 diabetes, has gained popularity for its off-label use in weight loss, leading to incre…

A Golden Opportunity for Compounding Pharmacies: Navigating the Ozempic Shortage
There has never been a more fortunate time for compounding pharmacies looking to capitalize on the "Gold Rush" of Ozempic. Due to…

Semaglutide Compliance Program: A Must Have
The semaglutide industry is relatively new, and significant regulatory enforcement typically lags by at least two years. According…

Federal Prosecutors Focus on Ozempic Violations
Intense semaglutide demand has now drawn the attention of regulators beyond the Food & Drug Administration (FDA) and state boards.…

Express Scripts FWA Investigative Alert: Crackdown on CoverMyMeds Provider Accounts
Express Scripts is targeting prior authorization Fraud, Waste & Abuse involving the use of CoverMyMeds provider accounts by pharma…

Increased Scrutiny for DEA Registration Applications
DEA registration applications are receiving increased scrutiny as DEA turns its sights on providers and pharmacies to curtail cont…

Medicare Advantage Cuts to Increase PBM Pressures
Insurers have bet big on Medicare Advantage, but the government is slowly cutting back. Faced with rising medical loss ratios and…

Pharmacy Alert: Texas Board of Pharmacy Investigations
Texas pharmacies are facing increasing scrutiny by the Board of Pharmacy, which is working closely with the DEA and other federal…

Semaglutide Demand is Skyrocketing: Ozempic Opportunities
As summer approaches, soaring demand for weight-loss drugs like Ozempic, Wegovy, and semaglutide compounded copies, will exacerbat…

MFCU Agrees Not to Charge HLA Client Following PBM Audit Referral
PBM audits must be handled correctly or severe consequences may result. In this case, HLA was able to persuade prosecutors not to…

HLA Wins Dismissal of Criminal Charges After PBM Audit
Health Law Alliance has successfully challenged OptumRx's termination decisions for numerous pharmacies, ensuring they can continu…

HLA's Coffey Appointed by Attorney General
HLA's Nancy Coffey, a former government official and healthcare expert, has been appointed to serve a three-year term as an indepe…

SafeGuard Audits: Don't Let CMS's Contractor Infringe Your Rights
Providers need to know their rights when it comes to investigations and audits by CMS UPIC contractors, such as SafeGuard and Qlar…

State PBM Reform in Jeopardy After Mulready
The federal government continues to bring enforcement actions relating to false prior authorizations given the high-priced medicat…

Walgreens Must Face Lawsuit Based on False Prior Authorizations
The federal government continues to bring enforcement actions relating to false prior authorizations given the high-priced medicat…

DOJ Maintains Focus on Inventory Shortfalls
Department of Justice prosecutors continue to file numerous cases against pharmacies and their owners for inventory shortfalls and…

HHS-OIG Prioritizes 2024 Pharmacy Audits
Based on a recent announcement, the federal government (HHS-OIG) will be prioritizing audits of pharmacy claims in 2024. This furt…

DEA's Dangerous New Agenda
Although DEA has long targeted wholesalers as the "choke-point" for stemming diversion, the Agency has now shifted its focus to do…

PBM Audit Response Summary
PBM audits can be resolved successfully, but more frequent and aggressive audits will require careful planning. Providers should a…

Firm Overview & Capabilities
In this article we profile the The Health Law Alliance, a specialized healthcare boutique with a team of experts in government inv…

Off-Label Prescribing and Dispensing: Ozempic, Wegovy, and Other Medications
Anthony Mahajan delves into the intricacies of off-label prescribing and dispensing for medications such as Ozempic, Wegovy, and R…

Federal Investigation for OTC Cards is Expanding
Federal prosecutors are expanding a healthcare fraud investigation, charging New York pharmacy owners and employees for violations…

NYRx Transition May Increase Medicaid Program Risk
The transition of Medicaid pharmacy benefit to NYRx in New York brings increased dispensing fees but also heightened audit and enf…

Semaglutide Compounding Pharmacies Subject to Increasing Regulatory Threats
Semaglutide compounding pharmacies face regulatory threats as state boards interpret statutes restrictively; Health Law Alliance,…

Health Law Alliance Recovers More than $20M Unlawfully Seized from Clients by Financial Institutions
Health Law Alliance, with Anthony Mahajan at the helm, recovers $20M+ unlawfully seized by financial institutions, highlighting po…

Novo Nordisk’s Recent Lawsuits to Stop Semaglutide Compounding are Baseless
Anthony Mahajan, an attorney at Health Law Alliance, contends that Novo Nordisk's recent lawsuits against Florida compounding phar…

How PBM Audits Can Provoke Government Scrutiny
Health Law Alliance's Anthony Mahajan discusses the potential outcomes and strategies related to Pharmacy Benefit Manager (PBM) au…

Federal Prosecutors Drop Criminal Charges Against Specialty Pharmacy Owner Relating to False Prior Authorizations
Federal prosecutors have decided not to prosecute the CEO of a Florida specialty pharmacy, represented by Health Law Alliance's An…

OIG Accepts Healthcare Fraud Self-Disclosure by Physician and Physician Group
Health Law Alliance, led by Anthony Mahajan, announces the acceptance of a self-disclosure by OIG on behalf of Shore Orthopaedic U…

OIG Accepts Healthcare Fraud Self-Disclosure by Pharmacy
Health Law Alliance, under Anthony Mahajan's guidance, reports the successful acceptance of a self-disclosure for Delmar Pharmacy…

Inventory Shortfall Case Studies
Health Law Alliance, under Anthony Mahajan's leadership, celebrates favorable outcomes in federal and state cases involving invent…

Key PBM Audit Considerations
Health Law Alliance provides an overview of the PBM audit process and relevant background for providers who suddenly find themselv…

Defending Inventory Shortfalls
Health Law Alliance addresses the complexities of defending against inventory shortfalls in the context of PBM audits, emphasizing…

Potential Windows of Opportunity
Health Law Alliance, specializing in PBM audit defense, highlights the potential benefits of discrepant PBM audits as early warnin…

OIG’s Self-Disclosure Protocol
Healthcare providers facing PBM audits can leverage the OIG's Self-Disclosure Protocol (SDP) to reduce liability by self-reporting…

When to Seek Help
Providers facing PBM audits must decide whether to rely on internal staff or seek audit counsel from experienced attorneys, partic…

Audit-Related Prosecutions Rise Sharply
Federal prosecutors are now pursuing felony charges under Section 1035 for false statements in pharmacy audits, extending the risk…

