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Of Counsel · Health Law Alliance

Damon McDougal

State Prosecutor | Former Criminal Defense Attorney · NJ | 4 Consecutive Jury Acquittals · Essex County

Damon McDougal is a state prosecutor and former defense attorney with particular expertise in courtroom proceedings and jury trials. He has tried dozens of significant cases on behalf of the government and routinely works with investigators from various state agencies. As a defense attorney, Damon earned a consecutive string of four jury acquittals over a two-year period in Essex County, New Jersey, and served clients in federal and state court matters for nearly a decade. He earned his J.D. from Fordham University School of Law, where he was a member of the Fordham Environmental Law Journal.

Latest Articles
12 articles
Ketamine Marketing

Ketamine Marketing Risks for Mental Health Providers

Ketamine marketing is under increasing regulatory scrutiny, with providers facing risk over claims, off-label promotion, and patient targeting. Even well-intentioned messaging can trigger audits or enforcement if it crosses compliance lines.

March 26, 2026
PBM Audit

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 terminations. Without precise documentation, even well-established prescriptions can put pharmacies at serious financial and operational risk.

March 18, 2026
PBM Audit

HLA Wins Full Reversal of PBM Credentialing Denial for an Independent Pharmacy

This week, Health Law Alliance achieved full reversal of a PBM credentialing denial for a New York pharmacy—mere weeks after it received a termination notice. Read more to learn how Health Law Alliance’s tireless advocacy can help your pharmacy in credentialing disputes.

March 19, 2026
PBM Audit

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 massive recoupments and even terminations. Without airtight documentation and clear procedures, even compliant pharmacies can face serious financial and legal risk.

March 18, 2026
Ketamine Compliance

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 is essential to reduce risk and stay ahead of enforcement.

March 18, 2026
Wound Care

CMS Skin Substitute Reimbursement Limitations Signal Continued Scrutiny of Wound Care Providers in 2026

CMS’s 2026 reimbursement overhaul for skin substitutes signals more than cost control. It marks a sharp rise in audits, enforcement, and compliance risk for wound care providers. Clinics relying on advanced wound care billing should prepare now, as regulators and payers intensify scrutiny across documentation, utilization, and financial relationships.

March 18, 2026
GLP-1

Peptides: Legal and Regulatory Risks 503A Compounding Pharmacies Must Understand

FDA scrutiny of peptide compounding is intensifying, and 503A pharmacies are squarely in focus. If you compound, source, or dispense peptides, now is the time to assess your regulatory exposure before enforcement escalates.

March 23, 2026
Wound Care Audit

The 2025 Healthcare Fraud Takedown Is a Warning Shot for Wound Care Providers

Wound care is now an enforcement priority. The 2025 fraud takedown targets skin substitute billing, graft utilization, and Medicare compliance.

February 16, 2026
GLP-1

FDA and Novo’s Uncharted Waters to Exert Pressure on Hims & Hers and GLP-1 Compounders

Novo’s lawsuit against Hims & Hers, coupled with FDA’s referral to the DOJ, marks a direct escalation against 503A compounded semaglutide. If your pharmacy dispenses, compounds, or markets GLP-1 therapies, this is not a headline, it is a regulatory turning point.

February 16, 2026
FDA Enforcement

What Wells Pharma v. Zyla Life Sciences Means for Compounding Pharmacies and Outsourcing Facilities

A pending Supreme Court case could reshape how compounding pharmacies face litigation under state unfair competition laws tied to FDA approval standards.

January 26, 2026
Pharmacist / Attorney

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.

January 20, 2026
PBM Audit Triggers

Why Even Minor Documentation Errors Can Be Costly for Pharmacies Facing a PBM Audit

PBMs are using rigid documentation standards to recoup payments and pressure pharmacies. Minor clerical errors can now threaten reimbursement and network participation.

January 9, 2026
PBM Audit Triggers

The Hidden PBM Threat Putting Pharmacies at Risk: Affiliation-Based Network Terminations

PBMs are quietly expanding their power, terminating pharmacies based on affiliation rather than wrongdoing and putting entire businesses at risk overnight.

January 9, 2026
PBM Audit

Health Law Alliance Successfully Defends a New York Pharmacy in an Optum Audit

Facing an Optum PBM audit that threatened network participation, a New York pharmacy turned to Health Law Alliance for strategic legal guidance, resulting in a successful audit resolution and uninterrupted network status.

January 9, 2026
Peptide Compounding

FDA Targets GLP-1 and Peptide Compounding, Advertising and ‘Research Use Only’ Labeling

FDA ramps up enforcement on GLP-1s, peptides, RUO labeling, and compounding practices. See how 503A and 503B facilities are affected.

January 8, 2026
RAC Audits

The Performant Audit Playbook: How to Protect Your Practice from New York’s New Medicaid RAC

For years, New York healthcare providers have navigated the complex oversight of the Office of the Medicaid Inspector General (OMIG), primarily through its Medicaid Recovery Audit Contractor (RAC) vendors. In April 2025 the landscape shifted as the state engaged Performant Healthcare Solutions (“Performant”) as its exclusive Medicaid Recovery Audit Contractor (“RAC”).

January 8, 2026
FDA Enforcement

Darmerica - FDA Issues Warning Letter Targeting GLP-1 API Supply Chain Manufacturer

FDA issued a Warning Letter to Darmerica citing cGMP violations and improper distribution of GLP-1 and peptide APIs. Learn what this means for 503A compounding pharmacies and supply chain compliance.

January 7, 2026
Bailed Out

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 the evidence was weak and legal requirements were ambiguous.

December 16, 2025
PBM Enforcement Trends

PBM Enforcement Trends Independent Pharmacies Must Prepare for in 2026

Independent pharmacies are heading into 2026 under tighter PBM oversight, more aggressive audit practices, and evolving reimbursement models driven by regulatory pressure and DIR fee reform. To survive in this environment, pharmacies must strengthen compliance, documentation, and inventory controls while partnering with experienced PBM counsel to manage audits, protect reimbursements, and avoid network termination.

December 16, 2025
PBM Audit Triggers

PBM Audit Triggers: Understanding How Prescription Activity Is Evaluated

Pharmacy benefit managers (PBMs) increasingly use data analytics and algorithmic surveillance to identify “red flag” prescriptions and atypical dispensing patterns, which can trigger audits, recoupments, network terminations, and payment withholds for independent pharmacies. By understanding common PBM risk indicators and implementing strong compliance practices, internal audits, documentation, and timely legal support, pharmacies can reduce exposure and more effectively defend themselves during PBM reviews and appeals.

December 11, 2025
PBM Audit

Health Law Alliance Successfully Reverses OptumRx’s Network Termination for a Michigan Pharmacy

We are proud to announce that the Health Law Alliance has successfully reversed a network termination from OptumRx for a Michigan-based independent pharmacy.

December 7, 2025
Wound Care Audit

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 facing thousands in recoupments. Understanding how wound care audits progress is crucial to defending your practice from unjust penalties, and engaging counsel early is essential to protecting your practice. Learn how Health Law Alliance can help prepare a strategy-driven defense designed to minimize risk and preserve your practice’s reputation.

November 20, 2025
Wound Care

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 submitted to Medicare. Learn more about the settlement and how Health Law Alliance can protect your wound care practice before regulators come knocking.

November 17, 2025
Wound Care

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 CERT program still finds sizable fee-for-service improper payments - so a targeted audit can escalate quickly to payment suspensions and referrals if mishandled.

November 11, 2025
PBM Audit Risks

When Inventory Discrepancies Become Audit Nightmares: Understanding One of the Most Common and Costly Audit Findings

Inventory reconciliation is one of the most scrutinized areas in PBM and payer audits and even small discrepancies can trigger major financial, reputational, and regulatory fallout.

November 4, 2025
PBM Audit

Collateral Consequences of PBM Audits: What Pharmacies Need to Know

PBM audits can quickly escalate from routine reviews into high-stakes enforcement actions with lasting financial, reputational, and regulatory consequences for pharmacies.

November 4, 2025
ESI Win

Victory for an Independent Pharmacy: Health Law Alliance Successfully Reverses Over $30,000 in PBM Inventory Discrepancy Findings

Health Law Alliance successfully overturned more than $30,000 in alleged inventory discrepancy findings asserted by Express Scripts’ Special Investigations Unit (SIU) against a Texas pharmacy.

November 4, 2025
PBM Audit

Navigating PBM Audits: A Legal Guide for New Pharmacy Owners

New pharmacy owners face complex PBM audit requirements that demand strict documentation, accurate claims, and ongoing compliance. Establishing strong recordkeeping systems and proactive audit readiness can help prevent costly recoupments and protect long-term network participation.

October 8, 2025
PBM Audit

How Pharmacies Can Challenge Unfair PBM Audit Findings

PBM audits can leave pharmacies facing exaggerated findings, steep recoupments, and even network termination. With the right strategies and legal support, pharmacies can successfully challenge unfair results and protect their business.

September 29, 2025
PBM Audit

Top Red Flags That May Trigger a PBM Audit

PBM audits can be disruptive, costly, and often triggered by high prescription volumes, dispensing irregularities, or claim activity. Pharmacies can reduce risks through strong documentation, compliance, and legal support to challenge unfair findings and protect network status.

September 30, 2025
Telehealth Policy

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 learn about what’s set to change and key guidance for telehealth providers to prepare to adapt to pre-pandemic coverage rules.

September 30, 2025
OIG

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 billing data trends for remote patient monitoring (RPM) in Medicare, renewing its calls for increased oversight into RPM services. Learn more about the reports key findings.

September 30, 2025
Audit Defense

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. Read about how HLA fought tirelessly to rebut Optum’s allegations and how Health Law Alliance can defend your pharmacy from an unjust termination.

September 22, 2025
DME Audit

DME Supplier Defense Attorneys' Guide to the Different Types of Government Audits

For DME suppliers, a notice from CMS can be daunting, especially when you're trying to figure out the difference between a TPE, SMRC, and UPIC. Each of these audit contractors has a different mission, scope, and level of risk for your business. Our latest blog post breaks down the "alphabet soup" of CMS audits, explaining what each entity does, what they look for, and how you should respond when they contact you. Protect your business by understanding who is on the other side of the audit.

September 19, 2025
UPIC Audits

More Than a Records Request: The Threat of UPIC Audits for DME Suppliers

For DME suppliers, a letter from a Unified Program Integrity Contractor (UPIC) is not a routine records request; it's a high-stakes fraud investigation that can trigger payment suspensions and threaten your company's survival. Our latest article explores the aggressive tactics of these powerful auditors, identifies the specific CMS contractors that monitor and police the industry, and details the common billing patterns that can place your business directly under their microscope. Read our guide to understand the immense financial risks of a UPIC audit and learn how to prepare for and respond to this critical business threat.

October 13, 2025
DME Audit

Building an Audit-Proof Documentation System for Your DME Supplier Business

In a CMS audit, your documentation is your only defense. A missing signature or an incomplete progress note can lead to a costly overpayment demand. Is your record-keeping system truly protecting you? This article provides a blueprint for creating an audit-proof documentation system. We cover everything from intake checklists to monthly note requirements for wound care supplies, helping you ensure every claim is fully supported and ready for scrutiny.

September 11, 2025
DEA Victory

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 a DEA suspension against a Florida community pharmacy, restoring its full authority to dispense controlled substances. This outcome ensures uninterrupted patient care and underscores the firm’s commitment to protecting healthcare providers from government overreach.

September 8, 2025
Remote Patient Monitoring

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 two recent settlements involving RPM companies—Health Wealth Safe and Capital Health—and discuss key compliance takeaways for telehealth providers.

August 25, 2025
Ketamine Compliance

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 compliance defense essential to avoid steep fines and license risks.

August 21, 2025
PBM Advocacy

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 issues that directly impact patients, providers, and policymakers.

August 20, 2025
DME

By Appointment Only: How DME Suppliers Can Prevent Unexpected DME License Revocations

DME suppliers can prevent unexpected and costly license revocations by strategically applying with a "By Appointment Only" designation. This article explores the common compliance trap of failing unannounced site visits due to conflicts between standard pharmacy operating hours and Medicare's "posted hours" requirement for DME suppliers. "By Appointment Only" status is a crucial safeguard, which suppliers can take to implement to protect their DME billing privileges.

August 19, 2025
Controlled Substances

Resolving Prescription “Red Flags” Is No Longer Optional: Federal Scrutiny Tightens on Controlled-Substance Dispensing

Pharmacists must resolve “red flags” under the Controlled Substances Act’s corresponding-responsibility requirements before dispensing controlled substances. Overlooking warning signs, such as cash-paid, high-dose opioid prescriptions—can now trigger False Claims Act liability and massive penalties, as demonstrated by Walgreens’ $350 million settlement in April 2025.

August 15, 2025
EKRA compliance

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 mislead providers into providing patient referrals for medically unnecessary blood tests. In this article, we analyze the 9th Circuit’s ruling and what it means for the future of EKRA enforcement.

August 14, 2025
DEA Inspections

Collateral Consequences Mount Quickly After Adverse DEA Inspection

Adverse findings during a DEA inspection can trigger a chain reaction of serious consequences for pharmacies, including increasing fines, suspension or revocation of DEA registrations and pharmacy licenses, costly False Claims Act (FCA) lawsuits, and potential criminal liability.

August 13, 2025
Suspension Reversed

Heath Law Alliance Secures Reversal of a Medicaid Payment Suspension

Health Law Alliance successfully secured a full reversal of a Medi-Cal payment suspension for a California pharmacy, overturning speculative allegations made by the Department of Health Care Services. This case highlights the firm’s ability to protect healthcare providers against unjust enforcement actions and the critical value of experienced legal counsel in Medicaid and insurance disputes.

August 13, 2025
HIPPA

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 strengthen cybersecurity by making many previous guidelines mandatory and introducing new, more specific requirements. In this article, we outline seven key changes from the Proposed Rule and outline how providers can prepare their practices once the Rule is in effect.

August 10, 2025
DME Compliance

How DME Suppliers Can Maintain Compliance with Medicare Enrollment Requirements

If you are a Durable Medical Equipment (DME) supplier and you are fearful of being scrutinized by CMS or the National Provider Enrollment contractors for violating the onerous Medicare enrollment standards, we hope this article will help. It lays out the essential steps to maintain compliance with Medicare's enrollment requirements. We break down the complex regulations surrounding Medicare enrollment standards, covering everything from initial enrollment and accreditation to revalidation and reporting changes, and tells providers to reach out to Health Law Alliance if they are seeking advice.

July 24, 2025
OIG

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, offering key compliance guidance for telehealth arrangements involving the leasing of health care providers and other administrative services to a physician-owned professional corporation (PC). Learn more about the opinion and what it tells us about the future of telehealth regulatory compliance.

July 19, 2025
PBM Audit Victory

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 attorneys has achieved for our clients. Learn more about the stunning reversal and how Health Law Alliance’s tenacious advocacy can help your pharmacy in PBM disputes.

July 18, 2025
Case Dismissed

HLA Attorney Anthony Mahajan Secures Major Victory Over Cardinal as Federal Court Dismisses Lawsuit Against Independent Pharmacies

Health Law Alliance secured a major win for independent pharmacies with the dismissal of Cardinal Health’s lawsuit, exposing it as a baseless attempt to intimidate smaller providers. This outcome reinforces the firm’s commitment to protecting healthcare businesses from corporate overreach.

July 14, 2025
Telehealth Fraud

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, including $1.17 billion tied to telemedicine and genetic‑testing fraud that implicated 49 defendants - signaling the government’s continued crack‑down on virtual‑care abuses. The surge in criminal and civil actions, coupled with CMS suspensions and the new DOJ‑HHS False Claims Act Working Group, warns telehealth providers to rigorously audit their compliance practices or risk severe penalties and exclusion from federal programs.

July 12, 2025
Telehealth Audit

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 break down OIG’s findings and explain what they mean in an era where RPM audits are on the rise.

June 27, 2025
DME

Health Law Alliance Earns Reinstatement for DME Supplier Whose Medicare Billing Privileges Were Unjustly Revoked

Due to Health Law Alliance’s advocacy, a prominent DME vendor in Texas had their billing privileges reinstated this week, without having to jump through the arduous, costly hoops of a fair hearing in front of an Administrative Law Judge or a Departmental Appeals Board review.

June 16, 2025
Patient Access in Telehealth

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 telehealth providers with actionable strategies to ensure compliance with privacy regulations, such as HIPAA, while effectively using audio-only visits to increase access to care.

June 11, 2025
Red Flags in Telehealth

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 highlight a common scenario that could indicate fraud vulnerability, followed by practical steps to address it. With clear, actionable insights, the article will be an essential resource for telehealth providers aiming to safeguard their practice.

June 9, 2025
False Claims

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 submit false claims for payment to Medicare. Learn more about the ongoing lawsuit and how Health Law Alliance supports wound care providers to avoid legal scrutiny.

May 15, 2025
Doctor Acquitted

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 unprecedented acquittal in an otherwise unbroken string of 35 Insys-related prosecutions brought by federal and state prosecutors.

May 19, 2025
DEA Registration

DEA Registration Requirements for Healthcare Providers: How to Stay Compliant

Understanding DEA registration requirements is crucial for healthcare providers handling controlled substances. Compliance with state and federal regulations helps avoid legal risks and ensures smooth practice operations.

May 12, 2025
Surrender your DEA registration

Should You Voluntarily Surrender Your DEA Registration? What Healthcare Professionals Need to Know

Considering voluntarily surrendering your DEA registration? Our experts can help you navigate the process and understand your options. Call (800) 345-4125.

May 7, 2025
Manufacturer Returns

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 pharmacies and opines that Sun Pharma's attempt to recover refunds it paid on returned goods is prohibited by the federal Anti-Kickback Statute and state commercial bribery laws.

April 28, 2025
Subpoena Risks

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 handling. It's important to balance the duty to comply with court processes and privacy laws.

April 2, 2025
OIG Subpoena

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 regulatory violations. Understanding how to respond to an OIG subpoena effectively is crucial to protecting your practice.

March 31, 2025
Telehealth Indictment

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 protections, and provider risks post-Dobbs.

March 4, 2025
DEA New Rules

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 impact on telehealth providers.

February 25, 2025
Remote Patient Monitoring

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 fraud risks associated with RPM, and best practices for providers to ensure their billing/coding procedures for RPM services are legally compliant.

February 18, 2025
Phishing Audits

PBM Audit Alert: Express Scripts Targeting Pharmacies for "Claim Phishing"

Express Scripts is using aggressive audits and investigations to recoup the dollar value of test claims that were never paid. Don't let ESI intimidate you—contact us today for effective audit defense.

February 14, 2025
DEA Registration

A Step-by-Step Guide to Securing (and Keeping) Your DEA Registration

Learn how to obtain and protect your DEA registration with our step-by-step guide, updated for 2025 telehealth rules and audit trends—plus proven strategies to resolve denials and maintain compliance. Designed for healthcare providers by legal experts specializing in regulatory defense.

February 12, 2025
Cross-State Licensing

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 provide expert guidance on managing licensing requirements, navigating compacts, and understanding the legal limitations of interstate telehealth.

February 4, 2025
PBM Audits

PBM Audits: Proven Strategies, Practical Insights, and Expert Guidance

PBM audits extend beyond paperwork, assessing pharmacy operations, staff preparedness, SOPs, and compliance culture. Proactive strategies, training, and legal expertise ensure audit readiness.

January 23, 2025
PBM Audits in 2025

Navigating PBM Audits in 2025: A Guide for Pharmacies

Navigate 2025 PBM audits confidently: Key triggers, trends, and preparation tips to protect your pharmacy.

January 20, 2025
PBM Audits

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 penalties.

January 28, 2025
PBM Audits

Leveraging Technology to Stay Ahead of PBM Audits

How technology can transform audit readiness, making compliance less stressful.

January 30, 2025
PBM

How PBMs Profited from the Opioid Crisis: The Hidden Deals Fueling Addiction

Pharmacy Benefit Managers prioritized profits over safety, accepting rebates from opioid manufacturers and enabling unrestricted access, worsening the opioid epidemic.

January 23, 2025
Telehealth Fraud Prevention

Telehealth and Fraud Prevention: Protecting Your Practice

Address the increasing scrutiny telehealth providers face regarding potential fraud, waste, and abuse in virtual care. This article delivers expert insights into structuring telehealth practices to avoid fraud allegations, including strategies for compliance with the Anti-Kickback Statute, Stark Law, and other relevant regulations.

January 17, 2025
Telehealth in 2025

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 to remote care for now but leaving providers and patients uncertain about the future. This update outlines what the extension covers, highlights permanent changes, and offers guidance to help providers prepare for potential disruptions.

January 14, 2025
Telehealth in 2025

Telehealth in 2025: What Medicare Providers Should Know

During COVID-19, Medicare expanded telehealth access by waiving geographic restrictions, broadening provider eligibility, and covering more services. These temporary flexibilities are set to expire at the end of 2024, requiring providers to adjust to stricter pre-pandemic rules unless Congress intervenes.

December 15, 2024
DEA Inspections

DEA Inspections Overview: What to Expect and How to Prepare for a DEA Inspection

Learn what to expect during DEA inspections and how to protect your practice with proactive preparation strategies.

December 13, 2024
Patient-Provider Relationships

Establishing and Documenting Patient-Provider Relationships in Telehealth

Actionable steps to properly establish, document, and maintain these relationships, minimizing risks and enhancing compliance.

December 6, 2024
Telehealth 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.

December 3, 2024
Telehealth Prescribing

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 prescribing flexibilities that emerged during the COVID pandemic re: controlled substances; 2) the details of the proposed rule, and 3) what the rule means for providers.

November 29, 2024
Reimbursements

Maximizing Reimbursement for Telehealth Services

Offer telehealth providers a practical guide to navigating billing and reimbursement challenges specific to virtual care. This article will delve into coding practices, reimbursement parity, and strategies to optimize revenue by understanding insurer requirements for telehealth.

November 26, 2024
PBM Audit Triggers

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 to PBM audits. This article will offer a detailed watchlist of PBM audit triggers and present practical, actionable steps for minimizing risks of audit findings and compliance issues.

November 21, 2024
Telehealth Consent

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 actionable advice on navigating the regulatory landscape and practical steps to ensure legal compliance and patient safety.

November 19, 2024
Board investigation

Pennsylvania Board Closes Investigation of HLA Client with No Action

Telemedicine business models may prompt regulatory scrutiny, including board investigations. In this case, HLA's experienced defense attorneys successfully resolved a three-year, multi-state investigation with no licensing or other implications.

February 12, 2024
Charges Declined

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 and our tenacious advocacy ultimately convinced the Strike Force to decline prosecution, representing a complete win for HLA's client.

January 25, 2024
Charges Declined

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 and our tenacious advocacy ultimately convinced the Strike Force to decline prosecution, representing a complete win for HLA's client.

January 25, 2024
Termination Reversed

Triumph Over Optum: HLA’s Tenacious Advocacy Reverses Optum’s Termination of a Texas Pharmacy

Health Law Alliance successfully reversed Optum’s termination of a Texas pharmacy from its network, protecting the pharmacy from severe financial and reputational damage. Our healthcare attorneys used strategic legal expertise and negotiations to overturn the decision, ensuring the pharmacy could continue serving patients. This victory highlights our dedication to strong advocacy and proven results.

August 15, 2024
PBM Agreements

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 be enforced and how they affect dispute resolution for pharmacies.

August 15, 2024
COVID Test Kit Fraud

U.S. Justice Department Investigates Alleged Medicare Fraud Involving COVID-19 Test Kits

The U.S. Justice Department is investigating allegations of Medicare fraud, where senior citizens' ID numbers were used to order unwanted COVID-19 test kits. Learn more about the ongoing investigation and its implications.

August 29, 2024
Termination Reversed

HLA Convinces Optum to Reverse PBM Audit Termination

Health Law Alliance is pleased to announce that Optum recently agreed to reverse its network termination of a Texas pharmacy client despite significant claim discrepancies based on inventory shortages, patient denials, and other alleged violations of the terms and conditions of the Provider Manual and network enrollment agreements.

August 15, 2024
PBM Lawsuit

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 reimbursement that Optum unlawfully refused to release to our client prior to being sued.

August 15, 2024
Corporate Deals

Despite Litigation, Small Businesses Must Comply with Transparency Act

Discover how the new Corporate Transparency Act (CTA), effective January 1, 2024, will change the way businesses disclose ownership information.

December 31, 2023
Case dismissed

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 government against a cancer care provider for the submission of false Medicare claims for oncology drugs.

July 31, 2024
PBM Termination

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 Division, to stop Optum's termination of an independent pharmacy that dispensed medications on telemedicine prescriptions and force Optum to comply with federal and state "prompt payment" laws that prohibit withholding of reimbursement.

July 23, 2024
FTC Lawsuit

Pharmacy Benefit Managers (PBMs) Face Possible FTC Lawsuit

The Federal Trade Commission (FTC) plans to sue the top Pharmacy Benefit Managers (PBMs) for anti-competitive practices, including influencing drug prices and favoring their own networks, which disadvantage independent pharmacies and raise prescription drug costs.

July 10, 2024
Optum Audits

Victories Against Optum Rx: Protecting Pharmacy Clients Nationwide

Health Law Alliance has successfully challenged Optum Rx's termination decisions for numerous pharmacies, ensuring they can continue to operate and serve their communities. These victories highlight the firm's expertise in healthcare law and its dedication to protecting pharmacy clients from unjust PBM actions.

July 15, 2024
PBMs Condemned

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 profits, thereby inflating drug costs and overcharging patients, particularly for critical medications like cancer drugs.

July 9, 2024
Ozempic Seizure

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 increased scrutiny by authorities. Recently, U.S. Customs and Border Protection (CBP) officers in Cincinnati seized several shipments of the drug, underscoring the growing demand and associated risks.

July 8, 2024
Ozempic Shortage

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 the forecasted limited supply of the brand name drug, the FDA has put Ozempic on the shortage list, which will allow for a more accommodating set of rules regarding compounding and distribution of semaglutide-based drugs.

July 3, 2024
Ozempic Compliance

Semaglutide Compliance Program: A Must Have

The semaglutide industry is relatively new, and significant regulatory enforcement typically lags by at least two years. Accordingly, all participants involved in the semaglutide supply chain should implement well-designed compliance programs now to reduce the risk and severity of future regulatory action.

June 15, 2024
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