Robinson Cole LLP
High Contrast Mode

Danielle H. Tangorre has extensive experience counseling clinical laboratories, health care providers, behavioral health providers, hospitals, and other healthcare entities to navigate operational and compliance issues and assist with business transactions. Danielle takes a holistic approach to help her clients achieve their business goals within the regulatory maze of federal and state laws. In addition, Danielle regularly advises clinical laboratories and other health care entities with respect to federal and state fraud and abuse laws and represents clients before federal and state agencies related to payment disputes and investigations.

Danielle’s work with clients involves:

Compliance, Operational + Regulatory Matters

Danielle advises clients on operational and compliance issues, federal and state fraud and abuse laws, including the Stark law, Anti-Kickback Statute and the Eliminating Kickbacks in Recovery Act (as well as state law counterparts), the HIPAA (Health Insurance Portability and Accountability Act of 1996), corporate practice of medicine, reimbursement and billing compliance, and other regulatory matters.

As a result of her clinical ethics fellowship at the Alden March Bioethics Institute at Albany Medical Center, Danielle provides her clients with an uncommon, holistic perspective. With her experience in ethics and day-to-day experience in delivering care in the hospital, Danielle actively engages with and advises clients on the ethical and legal requirements related to delivery of health care services, consent issues, guardianship, and other advanced care planning.

Transactional

Danielle has experience representing health care providers with the buying and selling of practices, structuring transactions, joint ventures, and partnerships and conducting healthcare due diligence. She has counseled several health care providers through complex re-organizations and affiliations while navigating various business and healthcare regulatory concerns. Danielle also routinely advises clients on how to navigate complex federal and state laws and obtain required state consents.

Government Investigations

Danielle assists in conducting internal investigations and conducting the healthcare analysis as it relates to governmental inquiries conducted by the Centers for Medicare and Medicaid, state Medicaid Fraud Control units, the Office of Inspector General and the United States Department of Justice, as well as other state regulatory agencies.

Community Involvement

Danielle serves on the Board of Directors of the Ronald McDonald House of Charities of the Capital Region. She is also an Adjunct Professor at Albany Law School and an Assistant Adjunct Professor at Albany Medical Center. She was also previously a member of Albany Medical Center’s Institutional Review Board. Danielle also serves on the Advisory Board for the Government Law Center of Albany Law School.

  • Albany Law School of Union University (Juris Doctor)
  • Albany Medical School (Masters)
    • Bioethics
  • University of Virginia (Bachelors)
    • B.A., Political Philosophy, Policy and Law

  • State of New York
  • U.S. District Court, Eastern District of New York
  • U.S. District Court, Northern District of New York
  • U.S. District Court, Southern District of New York

Selected by her peers for inclusion in The Best Lawyers in America© in the areas of Administrative / Regulatory Law, Elder Law, and Health Care Law for 2026

Listed as a Future Star in Benchmark Litigation for 2026 and 2025

Selected as a Rising Star to the New York - Upstate Super Lawyers list from 2015 to 2025

Selected by her peers for inclusion in the Best Lawyers: Ones to Watch in the areas of Administrative / Regulatory Law, Elder Law, and Health Care Law from 2021 to 2025

Albany Law School
Advisory Board Member of the Government Law Center

New York State Bar Association

Albany County Bar Association

American Health Lawyers Association

Ronald McDonald House of the Capital Region
Secretary 
 

Publications


OIG Reiterates a Core Message: Stark Compliance and Fair Market Value Alone Do Not Shield Against Anti-Kickback Statute Risk teaser
April 24, 2026

OIG Reiterates a Core Message: Stark Compliance and Fair Market Value Alone Do Not Shield Against Anti-Kickback Statute Risk

Health Law Diagnosis
Legal Update: DOJ Announces First False Claims Act Settlement for “Illegal DEI Practices” teaser
April 14, 2026

Legal Update: DOJ Announces First False Claims Act Settlement for “Illegal DEI Practices”

Continuing Appropriations Act, 2026: Another Lifeline for Medicare Telehealth Flexibilities teaser
February 4, 2026

Continuing Appropriations Act, 2026: Another Lifeline for Medicare Telehealth Flexibilities

Health Law Diagnosis
OIG Reiterates a Core Message: Stark Compliance and Fair Market Value Alone Do Not Shield Against Anti-Kickback Statute Risk teaser
April 24, 2026

OIG Reiterates a Core Message: Stark Compliance and Fair Market Value Alone Do Not Shield Against Anti-Kickback Statute Risk

Health Law Diagnosis
Legal Update: DOJ Announces First False Claims Act Settlement for “Illegal DEI Practices” teaser
April 14, 2026

Legal Update: DOJ Announces First False Claims Act Settlement for “Illegal DEI Practices”

Continuing Appropriations Act, 2026: Another Lifeline for Medicare Telehealth Flexibilities teaser
February 4, 2026

Continuing Appropriations Act, 2026: Another Lifeline for Medicare Telehealth Flexibilities

Health Law Diagnosis
New Year Brings Old Obligations with a Recent Twist: PAMA Reporting is Back teaser
February 3, 2026

New Year Brings Old Obligations with a Recent Twist: PAMA Reporting is Back

The ColLABorative Brief
Medicare Part B Lab Spending Increased in 2024: Here’s what the Latest OIG Report Reveals teaser
February 2, 2026

Medicare Part B Lab Spending Increased in 2024: Here’s what the Latest OIG Report Reveals

The ColLABorative Brief
Eliminating Kickbacks in Recovery Act – 2025 Updates and Looking to 2026 teaser
February 2, 2026

Eliminating Kickbacks in Recovery Act – 2025 Updates and Looking to 2026

The ColLABorative Brief
DOJ Enforcement of Clinical Laboratories: Trends from Q4 2025 teaser
February 2, 2026

DOJ Enforcement of Clinical Laboratories: Trends from Q4 2025

The ColLABorative Brief
Song Remains the Same – Medicare Telehealth Services At Risk of Expiring Again on January 30, 2026 teaser
January 29, 2026

Song Remains the Same – Medicare Telehealth Services At Risk of Expiring Again on January 30, 2026

Health Law Diagnosis
South Carolina Lab Settles False Claim Act Case – A Study on Commercial Reasonableness and Disguised Kickbacks teaser
January 12, 2026

South Carolina Lab Settles False Claim Act Case – A Study on Commercial Reasonableness and Disguised Kickbacks

Health Law Diagnosis


New Year Brings Old Obligations with a Recent Twist: PAMA Reporting is Back teaser
February 3, 2026

New Year Brings Old Obligations with a Recent Twist: PAMA Reporting is Back

The ColLABorative Brief
Medicare Part B Lab Spending Increased in 2024: Here’s what the Latest OIG Report Reveals teaser
February 2, 2026

Medicare Part B Lab Spending Increased in 2024: Here’s what the Latest OIG Report Reveals

The ColLABorative Brief
Eliminating Kickbacks in Recovery Act – 2025 Updates and Looking to 2026 teaser
February 2, 2026

Eliminating Kickbacks in Recovery Act – 2025 Updates and Looking to 2026

The ColLABorative Brief
DOJ Enforcement of Clinical Laboratories: Trends from Q4 2025 teaser
February 2, 2026

DOJ Enforcement of Clinical Laboratories: Trends from Q4 2025

The ColLABorative Brief
Song Remains the Same – Medicare Telehealth Services At Risk of Expiring Again on January 30, 2026 teaser
January 29, 2026

Song Remains the Same – Medicare Telehealth Services At Risk of Expiring Again on January 30, 2026

Health Law Diagnosis
South Carolina Lab Settles False Claim Act Case – A Study on Commercial Reasonableness and Disguised Kickbacks teaser
January 12, 2026

South Carolina Lab Settles False Claim Act Case – A Study on Commercial Reasonableness and Disguised Kickbacks

Health Law Diagnosis

News


April 22, 2026

Danielle Tangorre Explains Significance of Groundbreaking Decision for Clinical Laboratories

Health Care Enforcement + False Claims Act Litigation team member Danielle Tangorre spoke with The Dark Report and G2 Intelligence about the significance of the U.S. Court of Appeals for the First Circuit  in U.S. ex rel OMNI Healthcare v. MD Spine Solutions LLC, et al that came down in December 2025. The decision affirmed a lower court’s dismissal of a “high stakes” False Claims Act lawsuit, providing clarity for the diagnostic laboratory industry. Danielle, along with team members Edward J. Heath and Seth B. Orkand, represented MD Labs in the appeals case. Covering the decision from a legal risk perspective, The Dark Report said, “this decision creates a new 'safe harbor' for medical necessity while defining the specific boundaries where that protection ends.” Danielle explained the decision enshrined that “clinical laboratories can generally rely on a physician’s order as evidence that testing is reasonable and necessary…[T]hat’s significant because labs bill for tests but do not treat patients. They rely on the physician’s clinical judgment.” Danielle noted, however, that the relationship is collaborative and labs also have a corollary duty. Danielle also highlighted how the decision shifted the burden of proof, as the First Circuit Court focused specifically on the intent required for a lab to be held liable for fraud. “The court also clarified that if a lab relies on a physician’s order, the burden shifts to the relator to show the lab should not have relied on it—for example, if the lab influenced or usurped the physician’s decision-making,” said Tangorre. “That’s a major takeaway for laboratories.” Because Circuit Court rulings are often cited by other courts across the country, the decision provides a defensive blueprint for labs facing similar allegations. The decision “provides clarity on how courts view a lab’s role in certifying medical necessity while relying on physicians,” Danielle said.  “It essentially gives labs guardrails: Labs can rely on physician orders, but here’s where you can run into trouble. Organizations that operate cohesively and not in silos are in the best position to manage risk,” Danielle concluded. G2 Intelligence’s "Lab Industry Advisor,” another leading publication for the clinical lab industry examined the decision by focusing on compliance elements of the case. The article said a practical takeaway from the case for clinical lab directors involves the design of test requisition forms. “The courts emphasized that MD Labs did not improperly design its requisition. That’s an important lesson. Labs need to ensure requisitions are not steering or influencing test selection,” Danielle warned. “The same applies to marketing. Overpromising test value or implying broader clinical utility than supported can create risk, even if labs can generally rely on physician orders.” While the appellate ruling focused on medical necessity, it allowed the lower court’s findings on independent contractor commissions to stand. The clinical lab industry has long assumed that paying commissions to independent sales agents is “per se” violation of the Anti-Kickback Statue or the Eliminating Kickbacks in Recovery Act. The MD Labs case suggests that context and compliance matter most. “Importantly, the relator did not appeal the independent contractor issue, so the finding that commission payments are not inherently illegal stands,” Danielle pointed out. “That aligns with a growing trend in the courts: Sales commissions are not automatically violations of AKS or EKRA unless there is some additional improper conduct—what I call a ‘plus factor’—such as influencing ordering behavior.” The court was persuaded by the fact that MD Labs had a robust compliance framework, Danielle said. “Independent contractors were treated similarly to employees, and compliance oversight was robust,” she added. “That’s critical.”

Dark Report
G2 Intelligence’s Lab Industry Advisor
March 23, 2026

Danielle Tangorre Discusses Pathology Arrangement Scrutiny in Healthcare

​​​​​​​AHLA's “Speaking of Health Law” Podcast
December 18, 2025

Business Transactions in Health Care Team Wins “Pharma & Devices Deal of the Year” at Global M&A Network’s 7th Annual USA Middle Markets M&A Atlas Awards Gala

Global M&A Network
Business Transactions in Health Care Team Wins “Pharma & Devices Deal of the Year” at Global M&A Network’s 7th Annual USA Middle Markets M&A Atlas Awards Gala teaser
April 22, 2026

Danielle Tangorre Explains Significance of Groundbreaking Decision for Clinical Laboratories

Health Care Enforcement + False Claims Act Litigation team member Danielle Tangorre spoke with The Dark Report and G2 Intelligence about the significance of the U.S. Court of Appeals for the First Circuit  in U.S. ex rel OMNI Healthcare v. MD Spine Solutions LLC, et al that came down in December 2025. The decision affirmed a lower court’s dismissal of a “high stakes” False Claims Act lawsuit, providing clarity for the diagnostic laboratory industry. Danielle, along with team members Edward J. Heath and Seth B. Orkand, represented MD Labs in the appeals case. Covering the decision from a legal risk perspective, The Dark Report said, “this decision creates a new 'safe harbor' for medical necessity while defining the specific boundaries where that protection ends.” Danielle explained the decision enshrined that “clinical laboratories can generally rely on a physician’s order as evidence that testing is reasonable and necessary…[T]hat’s significant because labs bill for tests but do not treat patients. They rely on the physician’s clinical judgment.” Danielle noted, however, that the relationship is collaborative and labs also have a corollary duty. Danielle also highlighted how the decision shifted the burden of proof, as the First Circuit Court focused specifically on the intent required for a lab to be held liable for fraud. “The court also clarified that if a lab relies on a physician’s order, the burden shifts to the relator to show the lab should not have relied on it—for example, if the lab influenced or usurped the physician’s decision-making,” said Tangorre. “That’s a major takeaway for laboratories.” Because Circuit Court rulings are often cited by other courts across the country, the decision provides a defensive blueprint for labs facing similar allegations. The decision “provides clarity on how courts view a lab’s role in certifying medical necessity while relying on physicians,” Danielle said.  “It essentially gives labs guardrails: Labs can rely on physician orders, but here’s where you can run into trouble. Organizations that operate cohesively and not in silos are in the best position to manage risk,” Danielle concluded. G2 Intelligence’s "Lab Industry Advisor,” another leading publication for the clinical lab industry examined the decision by focusing on compliance elements of the case. The article said a practical takeaway from the case for clinical lab directors involves the design of test requisition forms. “The courts emphasized that MD Labs did not improperly design its requisition. That’s an important lesson. Labs need to ensure requisitions are not steering or influencing test selection,” Danielle warned. “The same applies to marketing. Overpromising test value or implying broader clinical utility than supported can create risk, even if labs can generally rely on physician orders.” While the appellate ruling focused on medical necessity, it allowed the lower court’s findings on independent contractor commissions to stand. The clinical lab industry has long assumed that paying commissions to independent sales agents is “per se” violation of the Anti-Kickback Statue or the Eliminating Kickbacks in Recovery Act. The MD Labs case suggests that context and compliance matter most. “Importantly, the relator did not appeal the independent contractor issue, so the finding that commission payments are not inherently illegal stands,” Danielle pointed out. “That aligns with a growing trend in the courts: Sales commissions are not automatically violations of AKS or EKRA unless there is some additional improper conduct—what I call a ‘plus factor’—such as influencing ordering behavior.” The court was persuaded by the fact that MD Labs had a robust compliance framework, Danielle said. “Independent contractors were treated similarly to employees, and compliance oversight was robust,” she added. “That’s critical.”

Dark Report
G2 Intelligence’s Lab Industry Advisor
March 23, 2026

Danielle Tangorre Discusses Pathology Arrangement Scrutiny in Healthcare

​​​​​​​AHLA's “Speaking of Health Law” Podcast
December 18, 2025

Business Transactions in Health Care Team Wins “Pharma & Devices Deal of the Year” at Global M&A Network’s 7th Annual USA Middle Markets M&A Atlas Awards Gala

Global M&A Network
Business Transactions in Health Care Team Wins “Pharma & Devices Deal of the Year” at Global M&A Network’s 7th Annual USA Middle Markets M&A Atlas Awards Gala teaser
December 4, 2025

Health Care Enforcement Team Secures First Circuit Win for Clinical Lab in False Claims Act Appeal

November 12, 2025

Danielle Tangorre Shares 2026 Predictions Citing AI, Audits and Increased Enforcement Facing Clinical Labs

G2 Intelligence
November 6, 2025

Robinson+Cole Commends 62 Attorneys Recognized in 2025 Super Lawyers®

Recognition spans key regions and highlights the firm’s seasoned practitioners and emerging leaders in many business transactions and litigation practices
Robinson+Cole Commends 62 Attorneys Recognized in 2025 <i>Super Lawyers</i>® teaser
October 20, 2025

Conor Duffy and Danielle Tangorre Author Article on Expiration of COVID-Era Telehealth Policies amid Government Shutdown

Law360 Expert Analysis
October 8, 2025

Robinson+Cole Healthcare Transactions Team Represents The Pennant Group in One of 2025’s Largest Homecare and Hospice Transactions

August 28, 2025

Danielle Tangorre Discusses Lessons Learned From the Recent $14.6 Billion Healthcare Fraud Takedown

G2 Intelligence

December 4, 2025

Health Care Enforcement Team Secures First Circuit Win for Clinical Lab in False Claims Act Appeal

November 12, 2025

Danielle Tangorre Shares 2026 Predictions Citing AI, Audits and Increased Enforcement Facing Clinical Labs

G2 Intelligence
November 6, 2025

Robinson+Cole Commends 62 Attorneys Recognized in 2025 Super Lawyers®

Recognition spans key regions and highlights the firm’s seasoned practitioners and emerging leaders in many business transactions and litigation practices
Robinson+Cole Commends 62 Attorneys Recognized in 2025 <i>Super Lawyers</i>® teaser
October 20, 2025

Conor Duffy and Danielle Tangorre Author Article on Expiration of COVID-Era Telehealth Policies amid Government Shutdown

Law360 Expert Analysis
October 8, 2025

Robinson+Cole Healthcare Transactions Team Represents The Pennant Group in One of 2025’s Largest Homecare and Hospice Transactions

August 28, 2025

Danielle Tangorre Discusses Lessons Learned From the Recent $14.6 Billion Healthcare Fraud Takedown

G2 Intelligence

Events


Past

Redefining Audit Preparedness & Compliance for Future-Proof Payments

May 14 2026
Q1 Productions’ 33rd Tri-Annual Diagnostic Coverage & Reimbursement Conference
Past

The Slippery Slope to Enforcement: How Payor Audits Trigger Government Action—and How to Identify Compliance Risk Early

Apr 28 2026
2026 Executive War College
Past

Redefining Audit Preparedness & Compliance for Future-Proof Payments

May 14 2026
Q1 Productions’ 33rd Tri-Annual Diagnostic Coverage & Reimbursement Conference
Past

The Slippery Slope to Enforcement: How Payor Audits Trigger Government Action—and How to Identify Compliance Risk Early

Apr 28 2026
2026 Executive War College
Past

Under OIG Scrutiny: Translating 2025 Enforcement Trends Into Actionable Strategies for Laboratory Compliance, Test Utilization Optimization, and Enterprise-Wide Risk Mitigation in 2026

Apr 28 2026
2026 Executive War College
Past

Lab Compliance and Test Utilization: Prepare for 2026 and Beyond

Mar 25 2026
Whitehat Communications’ Point of Care Group Webinar Series
Past

Redefining Audit Preparedness & Compliance for Future-Proof Payments

Mar 18 2026
Q1 Productions’ 32nd Tri-Annual Diagnostic Coverage & Reimbursement Conference
Past

KnowledgeBridge: Proactive Approaches to Compliance: A Preventative Checkup

Jan 29 2026
Consero Healthcare Chief Ethics & Compliance Officer Forum
Past

Under OIG Scrutiny: Translating 2025 Enforcement Trends Into Actionable Strategies for Laboratory Compliance, Test Utilization Optimization, and Enterprise-Wide Risk Mitigation in 2026

Apr 28 2026
2026 Executive War College
Past

Lab Compliance and Test Utilization: Prepare for 2026 and Beyond

Mar 25 2026
Whitehat Communications’ Point of Care Group Webinar Series
Past

Redefining Audit Preparedness & Compliance for Future-Proof Payments

Mar 18 2026
Q1 Productions’ 32nd Tri-Annual Diagnostic Coverage & Reimbursement Conference
Past

KnowledgeBridge: Proactive Approaches to Compliance: A Preventative Checkup

Jan 29 2026
Consero Healthcare Chief Ethics & Compliance Officer Forum

Health Law Diagnosis Blog


Below is an excerpt of the Health Law Diagnosis blog posts authored by Danielle.

OIG Reiterates a Core Message: Stark Compliance and Fair Market Value Alone Do Not Shield Against Anti-Kickback Statute Risk

On April 23, 2026, the HHS Office of Inspector General (OIG) quietly—but pointedly—added two new FAQs to its “General Questions Regarding Certain Fraud and Abuse Authorities.” Although the principles articulated are not new, the timing and clarity of these FAQs reflect OIG’s continued effort to correct common—and risky—misunderstandings in the health care industry regarding the federal Anti‑Kickback Statute (AKS), the physician self‑referral law (“Stark”), and the role of fair market value (FMV) analyses. Together, these FAQs serve as a reminder that technical compliance with Stark or reliance on a fair market benchmark do not, standing alone, insulate an arrangement from AKS scrutiny. The first new FAQ is FAQ #4: “Could a financial arrangement that satisfies an exception to the physician self-referral law (42 U.S.C. § 1395nn) violate the federal anti-kickback statute?” In its answer, OIG squarely addresses a persistent misconception that satisfying a Stark exception somehow rebuts AKS risk. OIG emphasizes several foundational points: Stark and AKS serve different purposes, prohibit different conduct, and impose different consequences; Stark is a strict liability statute; intent is irrelevant; AKS is an intent‑based statute; knowing and willful intent to induce referrals is the core inquiry; and Compliance with a Stark exception is not evidence that the parties lack AKS intent. Even where a financial arrangement “fits” squarely within a Stark exception, the arrangement may still violate AKS if one purpose of the remuneration is to induce or reward referrals. To illustrate this point, the OIG provides the “sporting event” example. It pointed out that hospitals, laboratories, or other providers may offer sporting event tickets or entertainment to referring physicians. OIG acknowledges that such arrangements might, depending on facts, technically satisfy the Stark exception for nonmonetary compensation under 42 C.F.R. § 411.357(k). However, OIG warns that these forms of remuneration are “unlikely to receive protection under any safe harbor to the federal anti-kickback statute” and therefore remain subject to totality‑of‑the‑circumstances review, including intent. Importantly, OIG reiterates its long‑standing position that providing remuneration to referral sources can violate AKS regardless of Stark compliance, a theme echoed in enforcement actions and advisory opinions over many years. The second new FAQ is FAQ #17: “Can fair market value arrangements violate the federal anti-kickback statute?” This FAQ tackles another common compliance belief that fair market value may be the sole compliance cornerstone for AKS purposes. OIG again says no. While confirming that fair market value analyses are important and often one of the elements of a safe harbor, OIG stresses that fair market value is just one element and that compliance with a safe harbor requires meeting each element. As discussed in a prior podcast with the American Health Law Association, there are other factors that are important including commercial reasonableness. OIG expressly rejects the industry argument that FMV eliminates unlawful remuneration, calling that position inconsistent with (i) the statutory text, (ii) the regulatory safe harbors, and (iii) decades of OIG guidance that OIG characterizes as “consistent and unwavering.” Why These FAQs Matter Now Although neither FAQ announces new law, their explicit pairing and contemporaneous release is notable. OIG appears focused on dispelling two closely related myths that continue to surface in enforcement matters: “We meet Stark, so AKS isn’t a problem.” “We paid fair market value, so there’s no kickback.” For entities in the healthcare space, these FAQs signal that you must look at the totality of the arrangement and ask the hard questions surrounding the relationship.

Visit Blog

Continuing Appropriations Act, 2026: Another Lifeline for Medicare Telehealth Flexibilities

This post was co-authored by Paul Palma, legal intern at Robinson+Cole. Paul is not admitted to practice law. On February 3, 2026, President Trump signed HR 7148, the Consolidated Appropriations Act, 2026 (“the Act”) ending the 4-day partial government shutdown. The Act, part of a broader fiscal year (FY) 2026 spending package, includes a further extension of Medicare telehealth flexibilities that recently expired on January 31, 2026. Originally introduced as temporary pandemic-era measures, these telehealth policies have been repeatedly sustained through short term legislative extensions. Here’s what the latest development means for the future of telehealth care. Medicare Telehealth Flexibilities Extended by the Act Geographic and Originating Site flexibilities: Medicare beneficiaries may continue to receive telehealth services in any location through December 31, 2027. Expanded Practitioner Eligibility: Occupational therapists, physical therapists, speech-language pathologists, and audiologists may continue providing Medicare-covered services via telehealth through December 31, 2027. Telehealth for FQHCs and RHCs: Federally qualified health centers (FQHCs) and rural health clinics (RHCs) may continue providing telehealth services through December 31, 2027, including the provision of mental health visits via telehealth to Medicare beneficiaries without needing to meet annual in-person service requirements. Audio-Only Telehealth: Telehealth services can continue to be provided via audio-only communications systems through December 31,2027. In-Person Requirement for Mental Health Visits: Medicare patients receiving services for the diagnosis, evaluation, or treatment of a mental health disorder via telehealth may continue to do so without having received a Medicare-covered in person item or service through January 1, 2028. Telehealth for the Recertification of Hospice Care: Hospice physicians and nurse practitioners may continue having face-to-face encounters to recertify a patient’s eligibility to remain on hospice via telehealth through December 31,2027. While this bill once again provides temporary relief for telehealth services, Congress is currently considering legislation that would make the current telehealth flexibilities permanent. Notably, H.R. 4206 and S. 1261, the house and senate versions of the CONNECT for Health Act of 2025, were introduced in early 2025. Although progress on those bills has been limited since their introduction, they continue to enjoy strong bipartisan back with H.R. 4206 obtaining 212 cosponsors and S. 1261 obtaining 71 co-sponsors. We will continue to monitor the progress of these and other telehealth related bills and provide updates as they arise.

Visit Blog

New Year Brings Old Obligations with a Recent Twist: PAMA Reporting is Back

After uncertainty over the last few months, the last few weeks saw potential changes to the Protecting Access to Medicare Act of 2014 (PAMA) under section 6226 of the Consolidated Appropriations Act of 2026. On January 20, 2026, the House Appropriations Committee released the Consolidated Appropriations Act 2026, which included several healthcare extenders, among them revisions to the upcoming PAMA rate cuts and reporting deadlines. The Senate passed the bill on January 30, 2026, and went back to the House on February 3, 2026, at which point it has been set for President Trump’s signature.   First, there are no additional Clinical Laboratory Fee Schedule (CLFS) rate cuts scheduled for 2026.  The act then extends the phase-in of the rate reductions for an additional year, delaying this until 2027, 2028, and 2029. The act also updates the data collection period to use 2025 rather than 2019 data, and shifts the reporting period to May 1, 2026, through July 31, 2026.  While there is still possibility around the Reforming and Enhancing Sustainable Updates to Laboratory Testing Services Act (RESULTS) which was introduced in September 2025, it has not yet passed. As such, laboratories must prepare for PAMA with the changes implemented by the passage of the Continuing Resolution. PAMA requires independent, hospital outreach, and physician office laboratories to report private payor rate information and volumes every three years (or annually for Advance Diagnostic Laboratory Tests). CMS used this data to calculate rates under the Clinical Laboratory Fee Schedule (CLFS) to align Medicare payment with commercial market rates by developing a weighted median of the reported private payor rates. Due to underreporting (less than one percent of all laboratories reported data) and underrepresentation of key segments such as hospital outreach and physician office labs, the initial reporting cycle resulted in steeper payment cuts between 2018 and 2020 for laboratories than anticipated. Current rates are based on 2016 data that was reported in 2017. Congress has postponed reporting six times, and with the passage of the CR, the next reporting cycle will be May 1, 2026, through July 31, 2026, resetting the time period for applicable data and relieving labs from the burden (or near impossibility) of reporting 2019 data. What you need to know about PAMA Who must report? “Applicable laboratories” must report private payor rates to CMS. Applicable laboratory means a laboratory under 42 C.F.R. § 493.2 (the Clinical Laboratory Improvement Amendments definition of a laboratory) that: Bills Medicare Part B under its own NPI or for hospital outreach laboratories, bills Medicare Part B on the Form CMS-1450 under type of bill (TOB) 14x; Meets the “majority of Medicare revenue” threshold in a data collection period. Meaning that the laboratory receives more than 50% of its Medicare revenue (Parts A, B, & D including any applicable co-pays/deductibles) under the CLFS and/or Medicare Physician Fee Schedule; and Receives at least $12,500 in CLFS revenue during the data collection period. Entities that do not meet the definition of “applicable laboratory” are not permitted to report. Who is a private payor? A private payor includes any of the following: A health insurance issuer as defined in § 2791(b)(2) of the Public Health Service (PHS) Act; A group health plan as defined in § 2791(a)(1) of the PHS Act; A Medicare Advantage Plan under Part C as defined in § 1859(b)(1) of the Social Security Act (SSA); or A Medicaid Managed Care Organization as defined in § 1903(m) of the SSA. What is reported? An applicable laboratory must collect and report “applicable information” received during the data collection period for each laboratory test code subject to the data collection requirements. Applicable information includes: 1) the specific Healthcare Common Procedure Coding System (HCPCS) code for the test; 2) each private payor rate for which final payment has been made during the data collection period; and 3) the associated volume tests performed for each private payor rate. “Zero dollars,” payments that cannot be identified at the HCPCS level (i.e., bundled payments), payments that were under appeal during the data collection period, and tests billed with miscellaneous/NOC code are not to be reported. How to report? CMS has released a list of applicable HCPCS codes that are subject to PAMA’s data reporting and collection requirements. Additionally, CMS has released a spreadsheet template that an applicable laboratory may use to collect and report the applicable information for each test subject to reporting. The spreadsheet includes information on the HCPCS code, payment rate, volume at the payment rate, and NPI. This spreadsheet may be uploaded to the CMS Enterprise Portal. What happens if an applicable laboratory fails to report? If the Secretary determines that an applicable laboratory has failed to report or has made a misrepresentation or omission of reporting information, the Secretary may apply a civil monetary penalty of up to $10,000 per day for each failure to report or each misrepresentation or omission. Beyond civil money penalties, failure to accurately report can negatively impact the weighted median of private payor rates leading to disproportionate CLFS rate cuts. Important Dates Data Reporting Period: May 1 – July 31, 2026 With the reporting period fast approaching, laboratories should determine whether they are an applicable laboratory and begin preparing the required 2025 private payor data carefully. As the reporting period approaches, CMS plans to issue additional fact sheets to assist labs in the data submission. Laboratories may want to consider consulting with knowledgeable legal counsel to ensure compliance and strategy alignment.

Visit Blog

Medicare Part B Lab Spending Increased in 2024: Here’s what the Latest OIG Report Reveals

This post was co-authored by Paul Palma, legal intern at Robinson+Cole. Paul is not admitted to practice law. Introduction On January 28, 2026, the U.S. Department of Health and Human Services Office of Inspector General (OIG) released a new report analyzing Medicare Part B (Part B) spending on laboratory tests in 2024. The Protecting Access to Medicare Act of 2014 (PAMA) requires OIG to publish an annual report detailing the top 25 clinical lab tests by expenditure. Each year, OIG evaluates Part B claims data for tests covered under the clinical laboratory fee schedule (CLFS). Below is a breakdown of the key trends highlighted in the 2024 report. Most notably, 2024 showed a significant rise in genetic and infectious Polymerase Chain Reaction (PCR) disease testing.  Overall Part B Spending and Enrollment Part B spending on clinical laboratory tests reached a peak of $7.9 billion in 2021 during the COVID-19 public health emergency, then declined to $7.8 billion by 2023. In a notable shift, spending rose again in 2024, increasing 5% to $8.4 billion, despite there being no changes to the CLFS since 2020. Strikingly, while overall spending increased, the number of Part B enrollees receiving lab tests fell by 15%, dropping from 27.7 million in 2018 to 23.4 million in 2024. According to OIG, this decline may reflect a broader migration of beneficiaries from Medicare Part B to Medicare Advantage (Part C) enrollment. “Genetic” Testing Continues to Rise The OIG report broadly defines “genetic” testing to include: (a) analysis of genetic material to monitor for genetic variations, mutations or other markers associated with disease or hereditary risk; and (b) analysis of genetic material from pathogens for bacteria or viruses. With the industry seeing an increase of PCR testing for infectious disease and detailed genetic antibiotic resistance testing, Medicare spending significantly increased in 2024. Historically, spending on non-genetic tests such as complete blood counts, metabolic panels, lipid panels, and thyroid tests have far exceeded spending on genetic tests relating to conditions such as cancer, fungal infection, and epilepsy. In 2018, genetic testing accounted for 18% of Part B spending on laboratory tests while 82% went to non-genetic tests.  By 2024, that gap had significantly narrowed with 43% of Part B spending on laboratory tests attributed to genetic testing compared to 57% for non-genetic testing. Over just one year (from 2023 to 2024), Part B spending on genetic testing increased by 20% from $3 billion to $3.6 billion. Utilization trends reflect this same shift. In 2018, 2.4 million Part B enrollees received at least one genetic test, out of the seven million total genetic tests performed that year. By 2024, the number of enrollees receiving at least one genetic test increased by 85% to 4.5 million while the total number of genetic tests performed that year increased by 160% to 18 million. In 2024, the average Part B enrollee received four genetic tests at a cost of $794 per enrollee, and 16 non-genetic tests at a cost of $207 per enrollee. In 2024, genetic testing related to infectious disease totaled $1.4 billion, up from $1.2 billion in 2023, and hereditary/disease genetic testing increased from $1.8 billion in 2023 to $2.2 billion in 2024. In 2024, a total of 346 laboratories received over $1M in reimbursement for “genetic” testing. Among them, 55 received over $10M in reimbursement for genetic testing. Top 25 Lab Tests So, now ranking at the top of the chart of all tests paid under Part B spending is CPT 87798 for infectious disease. Also ranking in the top 15 is CPT 87481.  The top 25 lab tests accounted for $4.1 billion, nearly 50% of all Part B laboratory spending in 2024. Among these, ten were genetic/PCR infectious disease tests, totaling $1.5 billion in Part B spending, while the remaining 15 were non-genetic tests totaling $2.6 billion in Part B spending. Notably, six of the ten genetic tests in 2024 showed at least a 30% increase in Part B spending compared to 2023. The OIG report focused on the fact that the average amount that Medicare Part B paid per enrollee for “genetic” tests approached $800, a 26% increase since 2023. Some of the largest growth was seen for tests billed under procedure CPT 87798, which reached $443 million in Part B spending, representing a 51% increase between 2023 and 2024. Takeaways The 2024 OIG report provides context for the increase in audits around the primarily used codes for infectious disease testing of 87798 and 87481. It also highlights the fact that genetic and PCR infectious disease testing is reshaping the Medicare Part B laboratory spending landscape. These types of testing, once a small share of the Part B landscape, now accounts for nearly half of all spending and continues to grow at a significant rate year after year. The impact of genetic and PCR infectious disease testing on Part B spending is highlighted by the increase in costs despite the decreased utilization.   Laboratories should recognize that genetic and PCR infectious disease testing has become a central driver of Part B costs which is resulting in a shift of audits and likely enforcement priorities by OIG to ensure that labs performing this type of testing are remaining compliant with all Medicare billing policies.

Visit Blog

Eliminating Kickbacks in Recovery Act – 2025 Updates and Looking to 2026

The Eliminating Kickbacks in Recovery Act (EKRA), enacted in 2018 as part of the SUPPORT Act, established a criminal statute prohibiting payments for patient referrals related to recovery homes, clinical treatment facilities, and laboratories. EKRA mostly mirrors the Anti-Kickback Statute (AKS) but extends its reach to commercial health insurance as well as federal programs like Medicare and Medicaid. Despite limited regulations and slow enforcement, some guidance emerged in 2025, though significant questions remain unresolved. National Fraud Takedown and EKRA EKRA drew some attention but generally remained a secondary focus. That changed in 2025, when an increase in allegations and indictments for EKRA violations occurred. During the 2025 National Fraud Takedown, several cases involved alleged breaches of both EKRA and the AKS. Kimberly Mable Sims, owner of a laboratory company, Francine Sims Super, office manager at a substance abuse treatment facility in North Carolina, and Keke Komeko Johnson, the Compliance Officer, were all indicted. In addition to accusations about gift cards, it was claimed that the substance abuse clinic routinely sent orders to Sims’s lab, which then performed urine drug tests on its patients and billed Medicaid. Allegedly, employees at the treatment center received kickbacks from the lab, while profits from referred specimens were equally split among the office manager, lab owner, and a biller. Earlier in 2025, Sims admitted guilt for EKRA violations. On August 25, 2025, Johnson and Super also pleaded guilty to paying kickbacks, resulting in a six-year sentence for Super. Ninth Circuit Clarifies EKRA In July 2025, in United States v. Schena, No. 23-2989 (9th Cir. July 11, 2025), the Court of Appeals for the Ninth Circuit upheld Mark Schena’s conviction for violating EKRA. Schena, who owned a laboratory, had paid marketing intermediaries to encourage referrals for questionable allergy tests. During the original trial, there was disagreement between Schena and the Department of Justice (DOJ) over how EKRA should be interpreted, particularly regarding whether the district court had correctly applied EKRA in S&G Labs Hawaii, LLC v. Graves, No. 1:2019cv00310 (D. Haw. 2021), aff’d, No. 24-823 (9th Cir. Jul 11, 2025) (unpublished). The Ninth Circuit panel considered two main issues: (1) whether marketing intermediaries were covered by 18 USC § 220(a)(2)(A); and (2) if payments to these intermediaries constituted “inducement” under EKRA. The court concluded that marketing intermediaries who interact with ordering providers can fall under EKRA, further clarifying that payments do not have to go directly to the provider to violate EKRA. Finally, the court addressed the confusion created by the district court’s  interpretation of EKRA was incorrect in S&G Labs Hawaii and realigned the Ninth Circuit’s reading of EKRA with other circuits’ approaches to the AKS. Regarding what “to induce” a referral means, the Ninth Circuit found that simply paying percentage-based compensation is not automatically a violation of EKRA. There must be intent to improperly influence providers’ referrals through false or fraudulent means. However, the court did not define exactly which situations would show wrongful attempts to sway medical professionals’ decisions. The case isn’t finished yet. Mark Schena has asked the United States Supreme Court to determine whether paying healthcare marketers a commission counts as “remuneration...to induce a referral” under EKRA. The Supreme Court has not yet decided whether it will hear the case. Other Notable EKRA cases A relator brought a False Claims Act case against a laboratory consortium of four interrelated companies (one investment firm and three executive), but the government declined to intervene.  The relator has proceeded with the case, and the amended complaint alleges violations of the False Claims Act based, in part, on violations of EKRA and the AKS. It is alleged that the laboratory consortium paid sales representatives based on the volume and profitability of laboratory testing specimens based on a percentage of its reimbursement.  The laboratory consortium argued: [U]nder Fifth Circuit precedent, Thompson’s allegations that defendants paid sales representatives volume- and profitability-based commissions is insufficient to plead a violation of the AKS and the EKRA, and Thompson must allege instead that the sales representatives improperly influenced the clinicians who sent samples to Apollo Labs and Arbor, such as by paying them a kickback or substituting their own judgment for that of the clinician. U.S. ex. rel Thompson v. Apollo Path LLC, No. 3:20-cv-02917, Dkt. 77, at 8 (N.D. Tex. Mar. 5, 2025). The court agreed, relying on U.S. v. Marchetti¸ 96 F.4th 818(5th Cir. 2024), and stated: In sum, a defendant’s payments to a third party to procure referrals from clinicians are made with the intent “to induce referrals” within the meaning of the AKS and the EKRA when there is evidence that the defendant intended for the third party to improperly influence the clinicians. Examples of improper influence include exploiting personal access and making the final decision about patient care. Id. at 14. In April 2025, the Court dismissed both the federal and state law claims. Id., Dkt. 94 (Apr. 30, 2025). Throughout 2025, there have been several indictments involving EKRA that have not necessarily involved laboratories but have been focused on substance abuse facilities, brokers, and marketing for sober homes and substance abuse facilities. A number of these actions are focused on California. See, e.g., United States v. Patton, No. 2:25-cr-00489 (C.D. Cal. June 17, 2025) (owner of a marketing company was indicted for allegedly referring patients with commercial health insurance to substance abuse treatment facilities); United States v. Mahoney, No. 8:21-cr-00183 (C.D. Cal. Mar. 21, 2025) (owner of addiction treatment facility sentenced to 41 months for violating EKRA) (appeal filed Mar. 2025); United States v. Simons, No. 3:25-cr-02444 (S.D. Cal. June 18, 2025) (CEO of multiple substance use disorder treatment facilities and sober homes was indicted for allegedly paying entities for marketing services).  Each of these focus on payment that varies based on referral quotas, a lesson that can be instructive for clinical laboratories navigating EKRA too.  Conclusion These recent developments in EKRA enforcement and judicial interpretation highlight the statute’s evolving scope and its increasing impact on laboratories, substance abuse facilities, and associated marketing practices. New Jersey expanded its patient brokering act to revise the law to specifically address substance user disorder treatment facilities and clinical laboratories. (Approved P.L. 2025, c.121). The Ninth Circuit clarified that EKRA can apply to payments made to sales representatives and that intent plays a critical role in determining whether such payments constitute improper inducement. However, Schena applied for certiorari at the Supreme Court. Texas dismissed a False Claims Act focusing on the lack of allegations regarding improper influence. Ultimately, the trajectory of recent cases signals that both regulators and courts are committed to upholding the integrity of clinical decision-making and preventing undue influence through financial incentives.

Visit Blog

DOJ Enforcement of Clinical Laboratories: Trends from Q4 2025

This post was co-authored by Paul Palma, legal intern at Robinson+Cole. Paul is not admitted to practice law. The final quarter of 2025 saw continued enforcement actions against clinical labs and other related healthcare entities. The Office of Inspector General (OIG) and Department of Justice (DOJ) heavily focused on False Claims Act (FCA) violations, Anti-Kickback Statute (AKS) violations, conspiracies, and COVID-19 related fraud. Below are highlights of these enforcement actions. Across Q4 2025, federal enforcement actions against clinical laboratories and related entities reflected consistent patterns of fraudulent genetic testing schemes, kickback arrangements, telemarketing‑driven referrals, and billing misconduct. Many cases involved medically unnecessary cancer genetic (CGx) and respiratory pathogen panel (RPP) testing, often ordered without patient contact, physician-patient relationships or proper clinical oversight. Enforcement also targeted laboratories that concealed ownership, shifted billing to evade scrutiny, or paid marketers, recruiters, and physicians to induce referrals. The DOJ and OIG continued to pursue individuals and entities that exploited Medicare beneficiaries—particularly older adults—through telemarketing campaigns, data harvesting, and fraudulent COVID‑19 test claims. Collectively, these actions underscore the government’s intensified focus on schemes that capitalize on vulnerable patient populations and exploit gaps in laboratory oversight. Enforcement agencies are also scrutinizing financial arrangements that mask kickbacks—whether framed as consulting fees, MSAs, or commission‑based compensation—as well as billing practices designed to maximize reimbursement through unbundling or duplicative claims Case Highlights On October 23, 2025, a New York doctor was sentenced to seven years in prison for participating in a scheme where he ordered CGx and other laboratory tests despite never treating, speaking to, or examining the patients in exchange for kickbacks. Specifically, he ordered CGx testing on Medicare beneficiaries who attended COVID-19 testing events at assisted living facilities, adult day care centers and retirement communities. On October 23, 2025, a lab owner that operated several laboratories out of Louisiana and Texas was sentenced to ten years in prison for orchestrating a scheme in which he conspired with telemarketers and call centers who implemented aggressive campaigns to induce beneficiaries to receive CGx and cardiovascular genetic testing. The orders were then signed by purported telehealth physicians who did not consult with, treat, or follow up with the beneficiaries receiving the testing. The owner also shifted billing between laboratories to evade scrutiny from Medicare and concealed ownership and control of the laboratories. On October 29, 2025, a clinical laboratory self-disclosed conduct and agreed to pay $85,000 for allegedly employing an excluded individual in violation of the Civil Monetary Penalties Law. On November 13, 2025, the owners of a telemarketing company were sentenced for their roles in a CGx testing fraud scheme where they targeted and steered Medicare beneficiaries to labs where they would receive medically unnecessary testing. Additionally, during a pending criminal case for genetic testing fraud, one of the owners opened a clinical laboratory and disguised his ownership of the laboratory. On November 17, 2025, an urgent care clinic agreed to pay $2.8 million to settle claims that they allegedly “unbundled” respiratory and urinary tract infection panel tests and billed for each individual component separately resulting in overbilling to federal health care programs. On November 20, 2025, the owner of two clinical laboratories pleaded guilty to one count of wire fraud for a scheme in which he paid his co-conspirators kickbacks to obtain the Medicare numbers and identifiers of patients without their consent. The lab owner then used the information to submit Medicare claims for COVID-19 test kits which were sent to patients who had not requested them. The owner also persisted after patients called stating that they had not requested the test kits. On November 20, 2025, a diagnostic laboratory agreed to pay $1.635 million to resolve allegations that the lab submitted claims for RPPs which were obtained through kickbacks or were medically unnecessary in violation of the FCA and AKS. More specifically, the government alleged that the lab entered into a Marketing Services Agreement (MSA) in which they paid a purported infection prevention company between $4,000 and $4,500 per facility per month for marketing and management services when, in reality, the MSA was a way to cover-up payments for laboratory referrals. Further, the laboratory allegedly combined RPPs with COVID-19 tests when facilities were only seeking COVID-19 tests. On November 24, 2025, it was announced that a diagnostic laboratory agreed to pay over $9.6 million to resolve allegations that it violated the FCA and AKS by submitting claims for RPPs that were medically unnecessary or obtained through kickbacks and by paying commissions to sales and marketing representatives based on volume or value of lab referrals which were later billed to Medicare. On December 2, 2025, a Georgia man was sentenced to 46 months in prison and ordered to pay $7.2 million in restitution for engaging in a scheme where he instructed recruiters to convince Medicare beneficiaries to accept medically unnecessary genetic testing. As part of the scheme, he created sham invoices documenting fabricated numbers of hours worked instead of the per-referral payments he received. As a result of the scheme, the man received $4.3 million in kickbacks and bribes. On December 2, 2025, a man was sentenced to two years in prison for his role in a conspiracy to bill Medicare for COVID-19 tests and RPPs which were never ordered or performed. On December 4, 2025, a clinical laboratory agreed to pay $758,000, plus additional amounts if certain financial contingencies occur, to resolve allegations that they violated the FCA and AKS by paying doctors and marketers illegal kickbacks which were disguised as consulting and medical director fees to induce laboratory testing referrals. In addition, the lab was also alleged to have paid independent contractors marketers’ commissions based on volume and value of referrals. This settlement also resolved an underlying lawsuit raised under the qui tam provision of the false claims act. On December 5, 2025, two Illinois men were indicted in a superseding indictment for their alleged role in a scheme to defraud federal and private health insurers by submitting fraudulent claims for COVID-19 laboratory testing services which were never provided and for participating in a conspiracy to launder the fraudulent proceeds by transferring the funds between laboratories and other businesses under their control. Takeaways Clinical labs should take these enforcement actions as warnings. First, conduct internal audits of referral relationships to ensure compliance with the AKS, as kickbacks remain a top enforcement priority and continue to monitor the arrangements in practice. Second, strengthen billing oversight and implement internal controls to avoid FCA exposure, which continues to drive multimillion-dollar settlements. Third, screen employees and contractors against exclusion lists to avoid potential violations of the CMP law. Finally, stay alert to evolving enforcement trends, including scrutiny of genetic testing, telemarketing arrangements, and lingering COVID-related fraud. Proactive compliance is essential for mitigating risk. The Q4 enforcement trends send a clear message that laboratory enforcement remains a top priority at the federal level. Now is the time for laboratories to review their compliance programs, oversight and monitoring practices and close any potential gaps.

Visit Blog

Song Remains the Same – Medicare Telehealth Services At Risk of Expiring Again on January 30, 2026

Healthcare providers are currently facing yet another termination of Medicare telehealth flexibilities at the end of the day on January 30, 2026, unless Congress acts on proposals to further extend the COVID-era flexibilities for telehealth. If no legislative action is taken before January 30, 2026, the providers and Medicare patients who have depended on expanded telehealth options will encounter substantial limitations in access beginning January 31, 2026.   As a reminder, in October-November 2025, in connection with the government shutdown, federal COVID-era telehealth flexibilities for Medicare beneficiaries expired, which led to significant billing challenges and restrictions in access for patients (which we previously discussed here). Those flexibilities were retroactively extended as part of the government funding bill passed in November 2025, through January 30, 2026. Health care providers, and their patients, are now in the same position of looking to Congress to act to further extend those flexibilities to protect continued access to telehealth services. It remains to be seen whether Congress will be able to pass another extension and, if so, how long the extension may be. There has been at least one proposal passed in the House of Representatives that would extend the telehealth flexibilities through December 31, 2027, but it remains to be seen if that will be taken up by the Senate. A summary of the existing telehealth waivers and their newly proposed expiration dates is included below. Key Telehealth Provisions Proposed to be Extended Geographic and Originating Site Flexibility: Without another extension, beginning January 31, 2026, Medicare beneficiaries may only receive telehealth services in approved health care facilities in rural locations (outside of metropolitan statistical areas); Note that the Social Security Act contains exceptions that would permit telehealth services at home (or other locations) for patients in specific circumstances approved by law or regulation, including patients being treated for: (1) symptoms of acute stroke; (2) substance use disorder; or (3) patients with mental health disorder; and (4) patients on home dialysis; Expanded Practitioner Eligibility: If the “cliff” is averted: Medicare patients would be allowed to receive care from approved Medicare-enrolled providers, which under the prior COVID-era waiver includes occupational therapists, physical therapists, speech-language pathologists, and audiologists; If the “cliff” is not averted:  Medicare beneficiaries will lose access to telehealth services provided by PTs, Ots, SLPs, and audiologists, all of whom play a key role in rehabilitation; Telehealth for FQHCs and RHCs: If the “cliff” is averted: Federally qualified health centers (FQHCs) and rural health clinics (RHCs) would be allowed to continue providing telehealth services to patients in other locations; Audio-Only Telehealth: If the “cliff” is averted: Telehealth services could continue to be provided via audio-only communications systems; If the “cliff” is not averted: Substantial limitation on coverage for audio-only services and providers must be technically capable of using audio-video technology; In-Person Requirement for Mental Health Visits: If the “cliff” is averted: Medicare patients may continue to receive mental health services from FQHCs and RHCs via telehealth; If the “cliff” is averted: Medicare patients receiving services for the diagnosis, evaluation, or treatment of a mental health disorder may continue to do so without receiving in-person care; If the “cliff” is not averted:  providers are required to furnish a Medicare-covered item to the beneficiary in-person at least six months prior to furnishing telehealth services. Additionally, the provider must furnish a Medicare-covered item in person at least once a year following each subsequent telehealth service. Note that the annual in-person follow-up requirement may be waived if the provider and beneficiary agree that the risks of receiving an in-person service outweigh the benefits; and Telehealth for the Recertification of Hospice Care: If the “cliff” is averted: Hospice physicians or nurse practitioners may continue having face-to-face encounters to recertify a patient’s eligibility to remain on hospice via telehealth. With the expiration date for the existing telehealth waivers looming, health care organizations should prepare to comply with additional telehealth restrictions beginning on January 31, 2026, similar to the situation faced in October 2025. We will continue to closely monitor this issue and will provide additional updates as soon as they become available.

Visit Blog

South Carolina Lab Settles False Claim Act Case – A Study on Commercial Reasonableness and Disguised Kickbacks

A clinical lab in Anderson, South Carolina, and its founder and CEO have agreed to pay a minimum of $6.8 million to settle a federal qui tam case based on allegations for paying illegal kickbacks to physicians in exchange for referrals of laboratory tests. Under the settlement agreement, this figure may increase to approximately $10.1 million if certain financial contingencies are triggered. The Government alleged that from March 2018 to November 2021, the laboratory and its CEO offered inducements aimed at directing referrals for clinical lab services. As part of the investigation and settlement, the DOJ identified and alleged five distinct types of illegal kickbacks: Fraudulent Contracts: Payments disguised as office rental, phlebotomy services, or toxicology services and allegedly falsified payments, square footage and hours in certification forms; Hand-Delivered Money Orders: The CEO personally delivered money orders to referring physicians to mask their intent; Inflated Equipment Sale: Inflated payment was made to a physician practice for used lab equipment in late 2016 to generate referrals; and Free Services and Supplies: A pain management practice was provided with free drug-screening services and supplies, securing consistent test referrals. The government focused on these kickbacks because the government claims it corrupted the impartiality of medical decision-making and improperly induced referrals, thereby violating the False Claims Act. As we start 2026, this case is another demonstration of the DOJ’s ongoing focus on laboratories and other healthcare providers and executives. It also highlights the importance of thoroughly vetting and asking questions around any arrangements, particularly those related to office rental space and phlebotomists and whether one purpose is to induce referrals. With references to documentation in the case of “certifications” of compliance, this highlights the focus on the “commercial reasonableness” prong of the safe harbor and highlights that purported documentation alone is not sufficient. Overall, this enforcement action underscores the legal and financial risks of non‑compliant referral arrangements. It serves as a strong reminder for laboratories and healthcare organizations to carefully audit and document all arrangements to ensure they are commercially reasonable, properly disclosed, and compliant with federal regulations—both to protect patients and avoid significant penalties. For a full overview, see the DOJ press release here.

Visit Blog

Update on Processing of Telehealth Claims Impacted During the Government Shutdown

The recent government shutdown caused multiple Medicare statutory payment provisions to lapse on October 1, 2025, due to the absence of Congressional action. With the passage of the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (Pub. L. 119-37), (discussed here), Congress has retroactively restored many of these provisions. The looming question at the time of the passage was whether there would be retroactive payments.  On November 21, 2025, Centers for Medicare and Medicaid Services (CMS) issued a Special Edition to clarify retroactive processing of claims. Telehealth and Acute Hospital Care at Home Claims On November 6, 2025, CMS instructed Medicare Administrative Contractors (MACs) to return certain telehealth claims submitted on or before November 10, 2025, that were previously non-payable after the lapse of statutory provisions. These claims are now payable if they meet all Medicare requirements. Practitioners should resubmit returned claims and any held telehealth claims. Refund any beneficiary payments for services now retroactively covered. The prior instructions to append the “GY “modifier are rescinded. Similarly, beginning November 10, 2025, MACs returned claims for the Acute Hospital Care at Home initiative for dates of service on or after October 1, 2025. Hospitals may resubmit these claims. Next Steps for ProvidersFacilities, practitioners, and suppliers should expect a return to normal processing operations soon.

Visit Blog

OIG Greenlights Sponsored Diagnostic Testing in Advisory Opinion 25-07

This post is co-authored with Paul Palma, legal intern at Robinson+Cole. Paul is not admitted to practice law. On July 2, 2025, the Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-07, which concluded that a pharmaceutical manufacturer’s proposed arrangement to sponsor a free, FDA-approved companion diagnostic test for eligible patients would not implicate the Federal Anti-Kickback Statute (AKS) or the Beneficiary Inducements civil monetary penalties (CMP). Background The requestor (a pharmaceutical manufacturer) produces an FDA-approved enzyme inhibitor. Treatment with the inhibitor is only appropriate with specific genetic deficiencies. A clinical laboratory developed an FDA-approved companion diagnostic test which is required to determine patient eligibility for the inhibitor. The two wished to work together. The Arrangement Under the parties’ proposed arrangement, the requestor pays the lab a fixed fee for each test performed on an eligible patient, and prohibits the lab from billing any patients, or payors other than the requestor for the testing. The test is offered to patients who: (i) have a prior negative result for a related genetic mutation; (ii) have previously collected tumor samples available for testing; (iii) have not previously received the test; and, in addition, (iv) the test must be used in accordance with FDA labeling. According to the requestor, this arrangement is designed to better identify patients whose deficiency has gone undetected and to determine whether use of the inhibitor would be appropriate. The requestor certified that the lab is contractually prohibited from: (i) referencing any of the lab’s other products on their “provider facing webpage;” (ii) promoting any of the lab’s or requestor’s other products in any “lab developed communications” to ordering providers or patients; and (iii) communicating with patients regarding the Arrangement unless required by law.  Additionally, the requestor certified that it would only receive “limited aggregated de-identified date” relating to the test through monthly reports. According to the requestor the reports would include: (i) the number of tests performed under the arrangement; (ii) the cumulative results of all tests performed under the arrangement, and (iii) digital awareness results including the source and number of visits to the the parties’ dedicated website and the clicks on the QR code in pamphlets that were left behind at the provider’s office . The requestor further certified that this data will only be used to: (i) better understand the number of patients with the condition which was missed by  standard testing; (ii)verify the amount invoiced the requestor; and (iii) ensure that the parties’ arrangement is “being conducted in accordance with the terms of the agreement between the lab and the requestor.” OIG Analysis Anti-Kickback Statute The OIG acknowledged that the arrangement could implicate the AKS by offering remuneration (i.e., the free test) that may induce referrals for federally reimbursable items or services and the safe harbor would not apply in this situation. However, OIG concluded that it would not impose sanctions for several reasons: The arrangement presents little risk of overutilization or skewing clinical decision making. The test determines whether the inhibitor would be an appropriate method of treatment for patients and would only be appropriate for patients presenting with the deficiency. The test may also show the drug is not indicated in approximately half the cases. Providers do not receive any remuneration from the requestor for prescribing the drug. Additionally, the requestor’s field personnel are prohibited from discussing the drug in relation to the arrangement. The requestor will only receive de-identified data which it certifies will not be used for sales or marketing purposes including sales targeting or incentives. The agreement prohibits the lab from promoting the arrangement to patients and providers and the requestor certified that it will not provide information about the arrangement to patients or providers directly. There are various safeguards in place to prevent this being used as a marketing or sales tool to steer providers to order any items or services from requestor or the lab, including the drug. Beneficiary Inducements CMP OIG also concluded that the parties’ arrangement does not violate the Beneficiary Inducements CMP. Although providing a free test constitutes remuneration, OIG found that the arrangement meets the statutory exception for promoting access to care with a low risk of harm. Specifically, the arrangement: May improve a beneficiary’s ability “to obtain items and services payable by Medicare or Medicaid” in instances when the inhibitor is covered by those programs. Is unlikely to interfere with clinical decision making because the test only confirms whether the inhibitor can be prescribed for a particular patient which a provider may already be considering. Does not raise quality of care or patient safety concerns because it is used to determine whether the inhibitor would be an effective treatment for a specific patient. Is unlikely to increase costs to federal health care programs because the inhibitor may be a life-extending treatment that is already under consideration by the provider. Additionally, the test will determine the appropriateness of prescribing the inhibitor and nearly 50% of patients will be ineligible for the inhibitor after testing. Finally, the arrangement does not incentivize providers to prescribe the inhibitor in any way. As is standard, OIG cautioned that its advisory opinion is limited to the proposed arrangement only and does not cover any other arrangements. OIG further cautioned that the opinion does not provide any opinion on liability in relation to the False Claims Act and, finally, that the opinion is only binding on the Department of Health and Human Services but no other government agencies. Takeaways The advisory opinion provides valuable insight into how OIG evaluates pharmaceutical manufacturer sponsored diagnostic testing programs under the AKS and CMP. By imposing certain structural safeguards including clear eligibility criteria, de-identified data sharing, and marketing restrictions manufacturers may be able to establish programs that increase access to care without implicating the AKS or CMP. The advisory opinion may provide a potential model for other labs and pharmaceutical manufacturers to enter into agreements where the manufacturer would sponsor companion laboratory tests. We will continue to monitor for additional guidance that OIG may issue on this and related topics.

Visit Blog