Articles by Anthony

The Medicare ALJ Hearing: What to Expect
The Medicare ALJ hearing is the third level of appeals: qualifying thresholds, hearing format, witness testimony, the OMHA backlog…

Applied Behavior Analysis Medicaid Audits
OIG's multi-state ABA audit series found improper billing in nearly every sampled case. Supervision, session notes, and authorizat…

Texas Medicaid OIG Audits and Investigations
HHSC-OIG audits Texas Medicaid providers under Chapter 531, with payment holds and a SOAH appeal route that runs on strict, unforg…

Ambulance Medicare Audits: Medical Necessity and Destination
Repetitive non-emergent ambulance transport draws Medicare scrutiny on medical necessity, destination rules, and run-sheet documen…

Physical Security Requirements for Controlled Substances
DEA's physical security rules for controlled substances set different storage, screening, and reporting duties for pharmacies than…

PDMP Obligations and Enforcement
State PDMP check-and-report mandates create a dispensing record. DEA and state boards use that record as evidence in diversion inv…

Reinstatement After Medicaid Exclusion
Completing a Medicaid exclusion period does not restore eligibility. Covers OIG reinstatement timing, application standards, and s…

Personal Care Services Medicaid Audits
How state Medicaid auditors use EVV records, attendant timesheets, and aide qualification files to build personal care services ov…

Taking a Medicare Overpayment to Federal Court
Providers must exhaust five levels of Medicare appeal before federal court review, then face a strict deadline and a narrow standa…

Signature Requirements in Medicare Documentation
How CMS defines a valid Medicare signature, when a signature log or attestation statement can fix a missing or illegible one, and…

Partial Fills of Schedule II Prescriptions
DEA rules allow partial fills of Schedule II prescriptions in three distinct scenarios, each with its own timing limits and requir…

Opioid Treatment Program DEA Obligations
DEA registration, SAMHSA certification, and state approval are all required before an OTP can dispense methadone or buprenorphine.

RAC Audits Versus UPIC Audits: Know Which One You Have
RAC audits chase improper payments for a contingency fee. UPIC audits investigate fraud and can trigger a payment suspension befor…

New Jersey Medicaid Fraud Division Investigations
New Jersey Medicaid audits can trigger a parallel Medicaid Fraud Control Unit investigation, with separate civil and criminal expo…

Emergency Oral Schedule II Prescriptions
DEA rules limit an emergency oral Schedule II prescription to the emergency period and require a written follow-up within 7 days,…

New York OMIG Audits: Process and Defense
New York's OMIG moves audits through a draft report, a 30-day response window, and a 60-day appeal deadline that cannot be extende…

QIC Reconsideration: Building the Record for ALJ
Level 2 of the Medicare appeals process sets a 180-day filing deadline and an evidence rule that can decide the case before it rea…

Employee Screening Obligations for DEA Registrants
DEA rules bar hiring anyone with a controlled-substance felony or a denied, revoked, or surrendered registration. What the duty to…

Michigan Medicaid Audits and Provider Defense
How MDHHS OIG audits Michigan Medicaid providers, when self-audit and disclosure options apply, and how the state's appeal process…

Physician Orders and Certifications Under Audit
What a valid Medicare physician order or certification must contain, the timing and signature rules, and the defects that trigger…

Medicaid Transportation Provider Audits
State Medicaid programs and MFCUs are auditing non-emergency medical transportation providers over trip logs, eligibility, and mil…

Modifier 25 Audits: Separately Identifiable Service
How Medicare contractors evaluate modifier 25 claims, the documentation that supports separately identifiable E/M services, and co…

Dispensing Controlled Substances to Out-of-State Patients
Nonresident pharmacy licensure, prescriber DEA registration, and shipping verification obligations for controlled substances sent…

Distributor and Reverse Distributor Registration
A guide to when pharmacy transfers, returns, or destruction of controlled substances trigger DEA distributor or reverse distributo…

Medicaid Self-Disclosure: When and How
When a discovered Medicaid overpayment calls for self-disclosure, the federal 60-day rule, state variation, and how to preserve po…

Medicaid Provider Agreement Termination
For-cause termination, non-renewal, and the reinstatement route under 42 CFR 455.416 and 455.101, and why procedures vary by state…

Medicare Revalidation: Getting It Right the First Time
The five-year cycle under 42 CFR 424.515, why a missed deadline triggers deactivation rather than revocation, and how to reactivat…

Medicare Reenrollment Bars: How Long You Are Out
The bar under 42 CFR 424.535(c) runs one to 10 years, longer for felony convictions or a second revocation, and it follows a physi…

DEA Registration Renewal and Lapse Consequences
The DEA's three-year renewal cycle, the 45-day rule that preserves authority during processing, and what a lapsed registration exp…

DEA Civil Penalty Settlements for Recordkeeping Violations
The current per-violation cap for DEA recordkeeping findings, how DEA counts violations, and when a finding stays civil instead of…

Medicare Appeals Council Review After an ALJ Loss
The 60-day deadline, the Council's de novo standard, and when escalating a Medicare ALJ loss toward federal court is worth pursuin…

Medicaid Payment Suspension: Getting the Hold Lifted
How the credible allegation of fraud standard triggers a Medicaid payment suspension under 42 CFR 455.23, and the good-cause argum…

Closing a Pharmacy: Transferring Controlled Substance Inventory
How a closing pharmacy must notify DEA before transferring inventory, take a closing count, surrender its registration, and retain…

Medicaid Managed Care Plan Audits Versus State Audits
How a managed care plan's SIU review differs from a state Medicaid program integrity audit, and why a provider can face both on th…

DEA Administrative Hearings: Process and Preparation
How the DEA administrative hearing process works under 21 CFR Part 1316, from the order to show cause through the public interest…

Medicare Redetermination: Winning at Level One
What a Medicare redetermination request must include, the 120-day filing deadline, and why treating Level One as a formality costs…

MAC Targeted Probe and Educate: What TPE Really Means
What triggers a Medicare Administrative Contractor's Targeted Probe and Educate review, the three-round structure, and the referra…

Medicaid Extrapolation Challenges at the State Level
State Medicaid extrapolation runs on state law, not the federal standard Medicare RAC and UPIC audits follow, and the sampling met…

Medical Necessity Denials: Building the Clinical Record
What Medicare auditors look for in the clinical record before denying a claim as not reasonable and necessary, and how physicians…

Medicaid Fair Hearings: Preparing Your Case
How a Medicaid provider should prepare evidence and witnesses before a fair hearing under 42 CFR Part 431, Subpart E.

ARCOS Reporting and What DEA Sees About You
ARCOS captures every controlled substance transaction from manufacturer to pharmacy, giving DEA data on your pharmacy before it op…

Buprenorphine Prescribing After the X-Waiver Repeal
The DATA-Waiver requirement for buprenorphine prescribing is gone, but a pharmacist's corresponding responsibility and recordkeepi…

Medicaid Dental Audits and Documentation
How Medicaid dental audits test radiograph support, medical necessity narratives for restorative work, and heightened pediatric cl…

Interest on Medicare Overpayments: How It Accrues
How interest accrues on a Medicare overpayment appeal under 42 CFR 405.378, how the rate is set, and what recoupment pauses do not…

Incident-To Billing: The Rules Auditors Apply
Medicare's incident-to billing rules require direct physician supervision and an established plan of care, and RAC and MAC auditor…

Perpetual Inventory as a Defense Against Shortage Findings
How a continuously reconciled perpetual inventory helps a pharmacist-in-charge document variance before a DEA shortage finding bec…

Refusal to Fill: Balancing Diversion Risk and Patient Care
How a pharmacist-in-charge weighs the corresponding responsibility to prevent diversion under 21 CFR 1306.04 against ADA patient a…

Medicaid Exclusion and Its Effect on Other Payers
How a state Medicaid exclusion reported to the OIG becomes a federal exclusion and a trigger for commercial payer network terminat…

Illinois Medicaid Audits and HFS-OIG Review
How the Illinois HFS Office of Inspector General audits Medicaid providers, recoups overpayments, withholds payments, and the appe…

Home and Community Based Services Audits
How CMS plan-of-care rules for 1915(c) and 1915(k) HCBS waivers work, what OIG audits have found, and the records providers need t…

Immediate Recoupment: Should You Request It
How Medicare overpayment interest under 42 CFR 405.378 weighs against a physician's appeal rights, and when requesting immediate r…

Failing Round Three of TPE: What Happens Next
What happens when a physician's error rate stays high after three rounds of TPE: MAC referral to CMS, prepayment review, extrapola…

Employee Drug Diversion: Detection and Response
Detection controls, internal investigation steps, and the DEA and state board reporting duties that apply once a pharmacy suspects…

Electronic Prescribing of Controlled Substances Compliance
What DEA's EPCS rule under 21 CFR Part 1311 requires of a pharmacist-in-charge: identity proofing, two-factor authentication, and…

Good Cause Exceptions to a Medicaid Payment Suspension
42 CFR 455.23(e) lets a state decline a Medicaid fraud payment suspension when beneficiary access to care is at risk, if the provi…

Georgia Medicaid Audits and Program Integrity Review
How DCH's Program Integrity Unit audits Georgia Medicaid providers, the records it demands, and the 10-day OSAH appeal deadline.

Face-to-Face Encounter Requirements and Audit Denials
How 42 CFR 424.22 and 42 CFR 410.38 define the Medicare face-to-face encounter, what the note must show, and why audits deny it.

Documenting Red Flag Resolution at the Counter
How pharmacist-in-charge documentation of red flag resolution under DEA's corresponding responsibility standard shows diligence, n…

Extended Repayment Schedules for Medicare Overpayments
ERS eligibility under 42 CFR 401.607, the hardship and extreme hardship showings, and structuring repayment around practice cash f…

DEA Form 41 and Controlled Substance Destruction
The DEA Form 41 witness rule, the reverse distributor's 30-day clock, and the documentation a pharmacy needs before destroying con…

E/M Level Selection Under Audit After the 2021 Changes
Since 2021, physicians choose an E/M level by time or medical decision making. Medicare audits test whether the note supports whic…

Florida AHCA Medicaid Audits: Overpayment Calculation and Hearing Rights
AHCA calculates Florida Medicaid overpayments through statistical extrapolation and gives providers 21 days to request a Chapter 1…

Electronic Visit Verification and Medicaid Audit Findings
Medicaid EVV records verify home visits, and mismatches are now central evidence in personal care and home health audit findings.

Corrective Action Plans After Medicare Revocation
A Medicare revocation opens a 30-day window for a Corrective Action Plan and a 60-day window for reconsideration, and missing eith…

DEA Form 222 and CSOS Ordering Errors
Schedule II orders run through DEA Form 222 or CSOS under 21 CFR Parts 1305 and 1311. Small recordkeeping errors in either draw in…

DEA Form 106: Reporting Theft or Significant Loss
The 45-day DEA Form 106 deadline, the one-business-day notice rule, and the six factors DEA uses to judge whether a loss is signif…

California Medi-Cal Audits and Recovery
How DHCS selects providers for a Medi-Cal audit, how the overpayment and withhold work, and the OAHA appeal sequence providers mus…

Behavioral Health Medicaid Audits
State Medicaid audits of behavioral health providers turn on service definitions, staff credentialing files, and time-based billin…

CMS-855 Enrollment Errors That Trigger Revocation
CMS revokes Medicare billing privileges over CMS-855 misrepresentation, missed 30-day ownership reports, and undisclosed felony co…

Change of Ownership and Medicare Enrollment Risk
A Medicare change of ownership can transfer the seller's overpayment liability to the buyer. What CHOW mechanics and CMS-855 timin…

Corresponding Responsibility: The Pharmacist's Duty
Under 21 CFR 1306.04, pharmacists share legal responsibility for every controlled substance prescription, including how they resol…

DEA Biennial Inventory Requirements: Getting It Right
DEA biennial inventory rules govern timing, exact counts by schedule, and retention. What a pharmacist-in-charge needs to get righ…

Marketing Arrangements in Telehealth: Where Kickback Risk Concentrates
Lead generators, per-consult fees, and telemarketing deals can cross from bona fide advertising into referral payments the Anti-Ki…

Practicing Across State Lines: Telehealth Licensure Enforcement
State boards can discipline telehealth providers who treat out-of-state patients without proper licensure, even when compact pathw…

Physician License Investigations: Standard of Care and Documentation Cases
A standard-of-care investigation turns on the chart, not the encounter. Peer review, NPDB reporting, and documentation gaps shape…

Telehealth Platform Agreements: Terms That Create Liability for Clinicians
Volume-based pay, clinical control limits, and one-sided indemnification clauses in telehealth platform agreements can expose phys…

Pharmacist License Defense: Common Allegations and Outcomes
How state pharmacy boards evaluate dispensing error, recordkeeping, and diversion allegations, and the outcomes each type typicall…

Remote Patient Monitoring Audits: The 16-Day Rule and Time Requirements
CMS's 2026 RPM billing changes reshape CPT 99453, 99454, 99457, and 99458, raising audit stakes for telehealth providers on device…

License Reinstatement: Building the Rehabilitation Record
A guide for physicians petitioning to reinstate a suspended or revoked license: eligibility windows, rehabilitation evidence, and…

National Practitioner Data Bank Reports: Triggers and Disputes
A National Practitioner Data Bank report can follow a physician for a career. What triggers a report, subject statement rights, an…

Inside an FCA Investigation: The Defense Timeline
How a False Claims Act investigation moves from civil investigative demand to DOJ decision, damages workup, and settlement for phy…

Suspicious Order Monitoring: What DEA Expects From Registrants
DEA requires registrants to design, operate, and document a suspicious order monitoring system, or face registration and civil pen…

Red Flags in Controlled Substance Dispensing: The Resolution Record
Federal law imposes corresponding responsibility on dispensing pharmacists. What a defensible red flag resolution record must cont…

When Auditors Pull Telehealth Prescribing Records
How Medicare and UPIC auditors evaluate telehealth prescribing records for synchronous-visit proof and patient identity verificati…

Telehealth Fraud Enforcement: What DOJ Actions Target
DOJ's 2026 national takedown charged 455 defendants and $6.5 billion in fraud, with telemedicine schemes again central to the patt…

License Cases That Run Beside Criminal Investigations
A medical board complaint and a criminal referral can arise from the same conduct, and a board statement can become evidence again…

Monitoring and Impaired-Practitioner Programs: Entry, Terms, and Exit
Voluntary and board-ordered PHP monitoring differ sharply in confidentiality. Here is what happens when compliance or completion i…

DEA Voluntary Surrender of Registration: What Form 104 Waives
DEA Form 104 ends a registration the moment it is signed and waives the right to a hearing. Here is what counsel can still preserv…

DEA Registration Denials and the Public Interest Factors
DEA weighs five statutory public interest factors before denying or renewing a physician's registration, and prior board disciplin…

Statistical Sampling in FCA Cases: Where Courts Draw Limits
Courts let sampling size FCA damages routinely, but proving liability by extrapolation turns on representativeness and sample meth…

The 60-Day Overpayment Rule: Identification, Quantification, and Repayment
CMS's 2025 rule replaced reasonable diligence with the False Claims Act's knowing standard for when a Medicare overpayment is iden…

Telehealth Billing Audits: Modifiers, Originating Sites, and Time
Medicare and Medicaid audits of telehealth claims focus on billing modifiers, the originating site requirement, and time-based doc…

Consent Orders in License Cases: What You Give Up and What You Keep
A consent order can end a licensing board case without a hearing, but it carries reporting and payor consequences that outlast the…

Prescribing Controlled Substances via Telehealth: The Current Rules
The DEA's telemedicine flexibilities for controlled-substance prescribing run through the end of 2026. Here is what prescribers ne…

How a Licensing Board Complaint Becomes an Investigation
How a state board of pharmacy or medical board complaint moves from intake through an investigator interview to dismissal, informa…

DEA Recordkeeping: The Audit-Ready Controlled Substance File
What pharmacies must document under DEA recordkeeping rules, from biennial inventories to theft and loss reports, before an inspec…

Responding to a DEA Order to Show Cause
A DEA order to show cause starts a 30-day deadline to request a hearing. Here are the grounds for revocation and the settlement pa…

The Materiality Defense After Escobar
The Supreme Court's Escobar decision made materiality a rigorous, fact-intensive defense in False Claims Act cases against healthc…

How a Qui Tam Lawsuit Unfolds: From Sealed Complaint to Intervention
A qui tam lawsuit under the False Claims Act moves through a sealed investigation before a physician or practice ever learns a cas…

DEA Inspections: A Pharmacy's Rights and Obligations
DEA investigators at the pharmacy door: the difference between a warrant and a consent request, and the lawful scope limits on eit…

DEA Immediate Suspension Orders: The Imminent Danger Standard
An Immediate Suspension Order halts controlled substance dispensing the moment it is served. Here is the imminent danger standard…

Parallel Proceedings: Managing Civil, Criminal, and Administrative Tracks at Once
An audit, a False Claims Act case, and a licensure action can arise from one billing pattern at the same time. Coordinating the th…

SMRC Audits: What Providers Should Know
The Supplemental Medical Review Contractor runs CMS-directed project reviews with a 45 day ADR deadline. Here is how compliance of…

OIG Exclusion: Scope, Screening, and Collateral Damage
An OIG exclusion bars billing to federal health programs and forces termination from any employer that receives federal funds, cli…

False Claims Act Damages and Per-Claim Penalties
Treble damages combine with a per-claim civil penalty to turn a modest per-claim error into ruinous total exposure, and claim volu…

FCA Civil Exposure vs Criminal Charges: Keeping Them Apart
A civil FCA demand and a criminal healthcare fraud charge trigger different statutes, standards, and remedies. Physicians need to…

From Desk to Courtroom: When a PBM Audit Leads to a Legal Battle
For many pharmacies, a PBM audit begins innocently enough. A letter arrives requesting prescription records, invoices, proof of de…

Health Law Alliance Secures a Reversal of OptumRx’s Network Termination for a California Pharmacy
Health Law Alliance recently secured a favorable outcome for a California independent pharmacy after OptumRx rescinded its decisio…

PBM Audit Defense Insights: Avoiding the Top PBM Audit Traps That Lead to Termination
For many pharmacies, a PBM audit begins as a routine request for records and ends with a startling realization: what appeared to b…

When “Retail” Isn’t Retail Enough: PBMs Increase Scrutiny of Mailed Prescriptions
Independent pharmacies have increasingly adapted their operations to compete with major pharmacy chains, finding ways to meet pati…

Health Law Alliance Successfully Prevents OptumRx Network Termination Following Pharmacy Audit
Independent pharmacies across the country continue to face aggressive scrutiny from Pharmacy Benefit Managers (“PBMs”) through aud…

Debunking 5 Common PBM Audit Myths That Put Pharmacies at Risk
For many independent pharmacies, receiving a PBM audit notice can feel like a routine administrative matter. But in today’s enforc…

Medicaid Self-Audit Demand Letters: Options Before You Certify
A Medicaid self-audit letter can convert a routine compliance review into False Claims Act exposure. Scope the response before you…

Medicare Payment Suspensions: Credible Allegations and the Path Back
CMS can suspend Medicare payments on reliable information or a credible fraud allegation, long before any hearing on the underlyin…

Corporate Integrity Agreements: Terms, Costs, and Negotiation
A Corporate Integrity Agreement binds a provider for five years, with IRO review, self-reporting duties, and stipulated penalties…

UPIC Prepayment Review: The Exit Strategy
A UPIC holding claims for individual review freezes cash flow claim by claim. Here is the documented path CMS requires to end prep…

When a UPIC Audit Becomes a Law Enforcement Referral
A UPIC audit can escalate into a referral to HHS-OIG or DOJ. Here is what triggers it and why the audit response matters.

Medicaid Payment Suspensions Under 42 CFR 455.23
A credible allegation of fraud triggers a mandatory Medicaid payment suspension under 42 CFR 455.23, but a written rebuttal can li…

Medicare Prepayment Review: Getting Off the Payment Hold
A Medicare payment hold can drain a practice's cash reserves. Learn how providers land on prepayment review and the exit criteria…

Billing Error or Fraud: Where Enforcement Draws the Line
Civil and criminal healthcare fraud statutes apply different knowledge standards. Documentation is what separates a billing error…

Stark Law vs the Anti-Kickback Statute: The Differences That Matter
Stark Law imposes strict liability on physician referrals. The Anti-Kickback Statute requires proof of intent. How the exposure di…

SafeGuard Services UPIC Audits: What Providers Should Know
SafeGuard Services LLC is the CMS UPIC for the Northeast and Southeast. Here is how its fraud reviews unfold and what providers sh…

The Five Levels of Medicare Overpayment Appeals
A physician's guide to Medicare overpayment appeals: filing deadlines, recoupment timing, and where cases are won at each level.

Medicaid Managed Care Audits: How MCOs and PBMs Enforce Contract Terms
Medicaid MCOs delegate pharmacy audits to PBMs under 42 CFR Part 438, but the network contract, not state regulation, controls the…

CoventBridge UPIC Audits: Process and Response
CoventBridge holds CMS's Midwest UPIC contract. Here is how its Medicare and Medicaid fraud reviews unfold, and how physicians sho…

Challenging Extrapolation in Medicare Overpayment Demands
A small claims sample can produce a six-figure Medicare demand. Learn how the sampling universe and methodology can be challenged.

A DOJ Target Letter: What Happens in the First 48 Hours
A DOJ target letter signals substantial evidence, not a guaranteed indictment. What happens in the first 48 hours often matters mo…

Medicaid Fair Hearings: Appealing Audit and Enrollment Actions
How the Medicaid fair hearing process works under 42 CFR Part 431: notice, evidentiary record, and preserving payment during appea…

Medicare Billing Privilege Revocations Under 42 CFR 424.535
A physician's guide to Medicare revocation grounds, the reenrollment bar, corrective action plan deadlines, and the appeal path un…

The Federal Healthcare Fraud Statute (18 USC 1347) Explained
A physician's guide to 18 USC 1347: the elements, intent standard, penalties on conviction, and the line separating it from civil…

Grand Jury Subpoenas in Healthcare Investigations
A guide to document and testimony subpoenas, grand jury secrecy, privilege, and production strategy for physicians facing a federa…

UPIC Site Visits: How to Prepare and What Inspectors Review
An unannounced UPIC site visit can arrive without warning. What inspectors review, how staff interviews work, and why counsel belo…

The Credible Allegation of Fraud Standard in Medicaid Enforcement
A thin, unverified referral can trigger a mandatory Medicaid payment suspension. Here is how states define a credible fraud allega…

UPIC Audits Explained: The Fraud-Focused Medicare Contractor
UPICs investigate suspected Medicare and Medicaid fraud, not payment accuracy. What a UPIC letter means and how its mandate differ…

Medicaid Exclusion and Termination: Collateral Consequences of an Audit
A state Medicaid termination for cause can trigger mandatory cross-state termination and federal OIG exclusion. What physicians sh…

When to Engage a Medicare Audit Attorney
The points in a Medicare audit where legal exposure escalates: extrapolated demands, prepayment review, fraud referrals, and revoc…

Responding to a Civil Investigative Demand (CID)
How a civil investigative demand works under the False Claims Act, what it can compel, and how to negotiate its scope before respo…

Responding to a Medicare Additional Documentation Request (ADR)
Medicare ADR deadlines run 45 days for MAC, RAC, and SMRC requests, 30 days for UPIC requests. What a complete response package mu…

The Anti-Kickback Statute: Remuneration, Intent, and Safe Harbors
A compliance guide to the Anti-Kickback Statute: the statutory elements, the one-purpose intent test, key safe harbors, and market…

Qlarant UPIC Audits: Jurisdiction and Process
Qlarant runs UPIC fraud investigations across the Western and Southwestern jurisdictions. What triggers a review, what the samplin…

Responding to a UPIC Records Request
A UPIC records request starts a 30-day clock, demands a complete production, and requires a privilege review most practices skip u…

State Medicaid OMIG Audits: Process and Defense
How New York's OMIG audit process works: records demands, the six-year lookback, extrapolation, and the 60-day window to appeal a…

CERT Audits and Error Rate Findings: The Provider Response
How the CERT program samples Medicare claims, calculates the error rate, and what a provider must do after an improper payment fin…

Medicaid Fraud Control Unit Investigations: What Providers Face
A Medicaid Fraud Control Unit investigation can proceed on a civil track, a criminal track, or both. Here is what providers need t…

The Medicare Audit Process: Contractors, Stages, and Deadlines
MAC, RAC, UPIC, SMRC, CERT: which Medicare contractor is auditing you determines the risk. The stages and deadlines every provider…

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…
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…

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…

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.

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…

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…

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…

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…

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…

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…

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…

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…

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…

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

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…

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.

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…

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…

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…
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…

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…

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

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…

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

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…

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…

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…

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…

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…

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…

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

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…

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

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…

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…

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…

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

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

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…

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

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

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

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

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…

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…

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…

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…

