Danielle Tangorre Comments in The Dark Report on Rulings in No Surprises Act Court Challenges

Health Law Group lawyer Danielle H. Tangorre was quoted in the article, “No Surprises Act Sparks a Slew of Court Decisions,” published in The Dark Report on September 11, 2023. The No Surprises Act requires insurers to determine the Qualifying Payment Amount (QPA) for the “same or a similar service that is delivered by a provider in the same or similar specialty” in the geographic region where the service is provided. The issue of QPA came up repeatedly in the court rulings. In August, parts of the government’s interim final rule that dealt with QPA calculation was struck down in a case brought by the Texas Medical Association. “QPA is thorny,” stated Danielle. “The government and the Texas Medical Association have taken very different approaches to interpretation of the statute regarding QPA. Part of the issue from the Texas Medical Association’s perspective—which represents the providers—is that the QPA can be an amorphous number that is hard to judge because a lot of the data used to calculate it is held only by the insurance companies.” Danielle reminded clinical lab managers and pathologists that the No Surprises Act does not apply to all diagnostic testing, which is an important delineation.

“There are discrete circumstances where laboratories are impacted by the No Surprises Act. If a lab gets referrals from a hospital or an urgent care center, then the lab needs to be following the No Surprises Act. “But if a lab gets its referrals from a doctor’s office or substance abuse facility, for example, the majority of the No Surprises Act doesn’t apply,” she added. Read the article.

Danielle Tangorre Quoted in The Dark Report on the End of Remote Readings by Pathologists

Health Law Group lawyer Danielle H. Tangorre was quoted in the article “CMS Ends Remote Reading of Pathology Glass Slides,” published in The Dark Report on May 30, 2023. On the day the federal government ended the public health emergency (PHE) for COVID-19, the Centers for Medicare and Medicaid Services (CMS) announced that remote reading of glass slides would no longer be permitted, a move previously hinted at but still unanticipated by clinical laboratory managers and pathologists. Danielle pointed out that given current staffing shortages in labs, the CMS announcement could make it even more challenging for labs to process glass slide reviews. “The CMS news has some huge impacts on workflow, particularly with the challenges of staffing right now. If labs have been using a remote workforce, including for the review of physical slides, now suddenly they have to pivot.” Earlier this year the American Clinical Laboratory Association took an active role in discussions with CMS about updated guidance, as the end of the PHE grew closer. Danielle suggested that, “If this restriction is going to a be a significant challenge, labs might want to think about reaching out to CMS or their state survey agencies. There is risk to doing that because a lab could basically disclose its noncompliance to CMS. Interested labs should weigh those risks. This may be where trade associations come in and ask CMS for more time to adapt to this change.” Moving forward from pandemic, reforms to the Clinical Laboratory Improvement Amendments of 1988 might be necessary. “CMS is taking into consideration the discussions within the Clinical Laboratory Improvement Amendments Committee (CLIAC) for the last four or five years,” Danielle said. “CLIAC’s recommendation is that digital reads are effective, and a variety of the trade associations have written that the pandemic proved that. So, I think CMS is slowly adapting to the concept of bio-informatics and related new technology being useful.” Read the article.

Danielle Tangorre Alerts Labs to Changes as PHE Ends in G2 Intelligence

Health Law Group lawyer Danielle H. Tangorre authored the article, “4 Things to Know About the End of the COVID-19 PHE,” published in G2 Intelligence on May 31, 2023. In the article, Danielle points out numerous issues that will be impacted by the termination of the COVID-19 Public Health Emergency (PHE) that officially ended on May 11, 2023. They include the End of HIPAA Flexibilities, COVID-19 testing, Stark Law and Anti-Kickback Waivers, and Remote Review of Laboratory Data and Pathology Digital Reads. Danielle suggests that, “as the PHE terminates and the pandemic-era flexibilities come to an end, laboratories should review their current policies and procedures and take appropriate steps to implement compliance.” Read the article.

Danielle Tangorre Quoted in G2 Intelligence Article on Recent DOJ Enforcement Actions

Comments from Health Law Group lawyer Danielle H. Tangorre closed the article “Urine Drug & Genetic Testing Remain Top Enforcement Targets,” published in G2 Intelligence on May 3, 2023. While there had been a lull in laboratory-related enforcement actions early in 2023, several high-profile cases recently announced by the U.S. Department of Justice involved unnecessary urine drug or genetic testing. This telegraphed that fraud involving toxicology labs remains a top priority for enforcement agencies, however, genetic testing-related fraud also continues to be a target. Danielle points out that the relative lack of COVID-19-related announcements up to April 20 doesn’t mean this area isn’t still important to enforcement agencies, but more likely reflects the fact that many such cases are still in “their investigative infancy.” She also notes that “the DOJ has tended to coordinate law enforcement actions related to COVID-19 healthcare fraud across multiple districts, often leading to delayed announcements,” citing the department’s April 20 announcement as a recent example. Read the article.

Danielle Tangorre Warns High Billing Labs Could Trigger Audits for G2 Intelligence

Health Law Group lawyer Danielle H. Tangorre discussed the continuing focus by regulating agencies on the clinical lab industry in her article “High Billing by Labs Continues to Be Trigger for Audits,” featured in the "National Lab Reporter" section of G2 Intelligence, on February 13, 2023. In the article, Danielle explains that the themes and take-aways of the December 2022 reports issued by the U.S. Department of Health and Human Services Office of the Inspector General are not necessarily new, as they continue the refrain from the regulating agencies that laboratories need to be mindful of compliance when it comes to billing. A lack of medical necessity, not upcoding, and being careful about bundling tests are concerns of the regulators and engaging in such conduct may signal that a laboratory is engaged in fraud, waste, and abuse. With an eye toward how this is likely to play out in 2023, Danielle suggests that as continued analysis is performed by regulatory agencies, laboratories should expect a continued focus and potential for audits particularly focused on COVID-19 tests and genetic testing. As there was a significant increase in spending by the government and presumably other payors, it is reasonable to expect a renewed focus on such increase. Laboratories should be diligent in a review of their claims and the analysis of medical necessity, upcoding, bundling, and overall billing compliance. Read the full article.

Danielle Tangorre Quoted in Dark Daily Article Highlighting Four Regulatory Developments on the Horizon for Clinical Labs

Health Law Group lawyer Danielle H. Tangorre was quoted in the article, “Four Regulatory Developments Coming This Fall That Are Relevant for Clinical Laboratory Leaders and Pathology Group Managers,” published in DarkDaily on October 31, 2022. A number of federal bills and regulations are anticipated this fall that could potentially affect how laboratory managers and staff do their jobs and how much Medicare reimbursement medical laboratories receive for certain diagnostic tests next year. Following the federal indictment in July of 13 defendants for alleged genetic testing and telemedicine fraud, the U.S. Department of Health and Human Services Office of the Inspector General (OIG) issued a warning about telemedicine fraud and identified seven “suspect characteristics” of telemedicine that could point to fraudulent Medicare billing.

“In the telehealth space, the issue the OIG has flagged is that genetic tests are being ordered without patient interaction or with only brief telephone conversations,” Danielle said. “Clinical laboratories need to make sure that they have proper requisitions and documentation for genetic testing that involves telemedicine.” Read the article.

Danielle Tangorre Quoted in The Dark Report Suggests OIG Report and LCDs as Guidance for Labs

Health Law Group lawyer Danielle H. Tangorre was quoted in the article, “Attorney Advises Labs to Track Genetic Test LCDs,” published in The Dark Report on September 19, 2022. The article considers what guidance exists for clinical labs following the nationwide Department of Justice takedown in July and the indictment of telehealth providers, labs, medical equipment companies, and pharmacies around the country. “Labs need to keep on top of the coverage determinations,” Danielle emphasized. “In the infectious disease testing space, an LCD (local coverage determination) went into effect recently which lists specific criteria for who can order the test…These LCDs include specific criteria for when the test is appropriate and when it’s medically necessary.” Danielle also suggested that labs consult a July 2022 Special Fraud Alert from the Office of the Attorney General. “…the OIG alert outlines seven characteristics of telemedicine that might point to fraud…Looking at the suspect characteristics is a great way for labs to review compliance…the OIG has flagged tests that physicians ordered without patient interaction or with only brief telephonic conversations. Labs must ensure that when they submit the bills and attest to the accuracy of the billing, that the test has been properly ordered.” Read the article.

Danielle Tangorre Quoted in G2 Intelligence Article Offering Lessons for Labs Following DOJ Takedown

Health Law Group lawyer Danielle H. Tangorre was quoted in the article “Compliance Lessons for Labs Following Massive Takedown,” published in G2 Intelligence on August 3, 2022. The article examines some steps labs may want to take in the aftermath of the 2022 National Health Care Fraud Enforcement Action, a nationwide Department of Justice (DOJ) takedown that ensnared telehealth providers, laboratories, medical equipment companies, and pharmacies. Danielle also suggests that labs refer to the Special Fraud Alert issued by the Office of Inspector General for the U.S. Department of Health and Human Services following the DOJ’s action, to determine what sort of relationships may be problematic moving forward. Read the article.

Danielle Tangorre Authors Legal Update on Changing Requirements for COVID-19 Testing

Health Law Group member, Danielle H. Tangorre, authored the Legal Update “COVID-19 Testing – Additional Considerations,” published on December 1, 2021. The article addresses the various state and federal regulations that were modified or suspended at the start of the pandemic to enable authorities to “suspend or modify various laws, rules, and regulations to accommodate and focus on efforts to respond to the pandemic.” She focused on the laboratory sector and accommodations that were necessary in response to the pandemic related to COVID-19 testing procedures, many of which now “have ceased and the laws, rules and regulations that laboratories relied on during the pandemic are no longer applicable.” Read the full Legal Update here. 

Danielle Tangorre Quoted in 360Dx Article on EKRA Compliance

Health Law Group lawyer Danielle H. Tangorre was quoted in the article “Recent Prosecutions Give Labs Insight Into DOJ's Use of Opioid Bill's Anti-Kickback Statute,” published in 360Dx on August 19, 2021. The article examines whether the passage of the Eliminating Kickbacks in Recovery Act (EKRA) of 2018, which was meant to outlaw patient brokering in the addiction treatment industry, criminalized common lab business practices such as paying sales staff on commission or placing phlebotomists in physician offices for sample collection. Danielle noted that while EKRA was written with the opioid crisis in mind, a recent case of a New York physician who was indicted for violations of several laws including EKRA as part of a scheme in which he solicited payments in exchange for referring pharmacogenetic testing to a pair of laboratories suggests it will be used to prosecute fraud in other areas, as well — genetic testing, for instance. "We were hoping for regulations or a fix for [the law] to be made more narrow, but we haven't seen that, and, instead, the cases are showing a broader applicability of how the [US Department of Justice] is using EKRA," [she] said. Danielle added that “while some labs outside the toxicology space might have been on the fence as to whether they needed to change their practices to comply with the law, ‘we can now point to these cases and say, you're a clinical lab, you need to be concerned about EKRA and how you conduct your business, whether it is how you structure your sales and marketing or how you address your pricing models. Labs need to think about it as they would any other statute.’" Launched in 2016, 360Dx covers emerging economic and technological trends in the clinical diagnostic market. Subscribers can read the article.

Danielle Tangorre Named to 2021 Upstate New York Super Lawyers® Rising Stars List

Health Law Group lawyer Danielle H. Tangorre has been named to the 2021 Upstate New York Super Lawyers® Rising Stars list. The Super Lawyers® designation is based on regional balloting by attorneys, third-party research, and a peer review process encompassing myriad practice areas. The selection process for the Rising Stars list is the same as the Super Lawyers selection process, with one exception: to be eligible for inclusion in Rising Stars, a candidate must be either 40 years old or younger or in practice for 10 years or less. While up to five percent of the lawyers in the state are named to Super Lawyers, no more than 2.5 percent are named to the Rising Stars list. An explanation of the Super Lawyers methodology can be found here.

Danielle Tangorre Presents Webinar on EKRA Compliance

Health Law Group lawyer Danielle H. Tangorre presented during the client, Lighthouse Lab Services', webinar, "How to Keep Your Lab EKRA Compliant" on July 28, 2021. The program offered an overview of compensation arrangements barred under the Eliminating Kickbacks in Recovery Act (EKRA), including safe harbor exceptions, how the law interacts with and differs from the Anti-Kickback Statute, and alternative compensation strategies for sales and marketing employees.

Robinson+Cole Lawyers Recognized in 2023 Super Lawyers®

A total of 35 Robinson+Cole attorneys were named to Super Lawyers® lists in the States of Connecticut, Delaware, Massachusetts, New York, Pennsylvania, and Rhode Island for 2023. In addition, 27 attorneys at the firm were recognized as “Rising Stars.”

Appellate Group chair Linda L. Morkan and Manufacturing Industry Team chair Jeffrey J. White were named to the Top 50: 2023 Connecticut Super Lawyers list. Linda also appears on the Top 25: 2023 Women Connecticut Super Lawyers list. Read more in the press release.

78 Robinson+Cole Lawyers Listed in The Best Lawyers in America© 2024

78 Robinson+Cole lawyers were selected by their peers for inclusion in The Best Lawyers in America© 2024. Of the 78 lawyers from across the firm’s practice groups and offices named to the list, 57 are from Connecticut. The firm continues to have the highest number of recognized lawyers in the state. Robinson+Cole also has the highest number of listed lawyers in Connecticut in the areas of environmental law and insurance law. Approximately, the top 5 percent of all practicing lawyers in the U.S. were selected by their peers for inclusion in the 30th edition of The Best Lawyers in America®.

Additionally, five lawyers were named Best Lawyers® 2024 “Lawyer of the Year” in the following offices, in the noted practice areas:

Hartford, CT – Best Lawyers® 2024 “Lawyer of the Year”

Jacqueline Pennino Scheib – Trademark Law

Michael R. Enright – Bankruptcy and Creditor Debtor Rights / Insolvency and Reorganization Law

Theodore J. Tucci – Insurance Law

Boston, MA – Best Lawyers® 2024 “Lawyer of the Year”

Michael S. Giaimo – Land Use and Zoning Law

Stamford, CT – Best Lawyers® 2024 “Lawyer of the Year”

Patricia D. Weitzman – Health Care Law and Litigation-Health Care

A Best Lawyers “Lawyer of the Year” designation is awarded to one lawyer in each of various high-profile specialties in large legal communities. These particular lawyers received the highest ratings among their peers for their abilities, professionalism, and integrity.

The fourth edition of Best Lawyers: Ones to Watch® in America was also released, which includes 23 Robinson+Cole lawyers. The “Ones to Watch” recognition is given to attorneys early in their careers for their outstanding professional excellence in private practice in the United States. The firm has the highest number of lawyers to receive this designation in Hartford, Connecticut. Read more in the press release.

Robinson+Cole Lawyers Recognized in 2022 Super Lawyers®

A total of 39 Robinson+Cole attorneys were named to Super Lawyers® lists in the States of Connecticut, Delaware, Massachusetts, New York, Pennsylvania, and Rhode Island for 2022. In addition, 30 attorneys at the firm were recognized as “Rising Stars.”

Jeffrey J. White was named to the Top 50: 2022 Connecticut Super Lawyers list. Linda L. Morkan appears on the Top 25: 2022 Women Connecticut Super Lawyers list and, similarly, Natalie D. Ramsey was included in the Top 50: 2022 Women Pennsylvania Super Lawyers list. Read more in the press release.

74 Robinson+Cole Lawyers Listed in The Best Lawyers in America 2023

74 Robinson+Cole lawyers were selected by their peers for inclusion in The Best Lawyers in America© 2023. Of the 74 lawyers from across the firm’s practice groups and offices named to the list, 54 are from Connecticut. The firm continues to have the highest number of recognized lawyers in the state. Robinson+Cole also has the highest number of listed lawyers in Connecticut in the areas of environmental law insurance law and construction litigation. Only the top 5.3 percent of all practicing lawyers in the U.S. were selected by their peers for inclusion in the 29th edition of The Best Lawyers in America®.

Additionally, the following five lawyers were named the Best Lawyers® 2023 “Lawyer of the Year” in Hartford, Connecticut, in the noted practice areas: Brian R. Smith in Land Use and Zoning Law, Christine E. Bromberg in Tax Law, James P. Ray in Litigation – Environmental, Joey Lee Miranda in Energy Regulatory Law, Norman H. Roos in Banking and Finance Law, Rachel V. Kushel in Employment Law – Management, Theodore J. Tucci in  Health Care Law and Virginia E. McGarrity – in Employee Benefits (ERISA) Law.

The third edition of Best Lawyers: “Ones to Watch” was also released, includes 23 Robinson+Cole lawyers. The “Ones to Watch” recognition is given to attorneys early in their careers for their outstanding professional excellence in private practice in the United States. The firm has the highest number of lawyers to receive this designation in Hartford, Connecticut. Read more in the press release.

Robinson+Cole Lawyers Recognized by Super Lawyers®

A total of 42 Robinson+Cole attorneys were named to Super Lawyers® lists in the States of Connecticut, Delaware, Massachusetts, New York, Pennsylvania, and Rhode Island for 2021. In addition, 29 attorneys at the firm were recognized as “Rising Stars.”

Bruce B. Barth and Jeffrey J. White were named to the Top 50: 2021 Connecticut Super Lawyers list. Linda L. Morkan appears on the Top 25: 2021 Women Connecticut Super Lawyers list and, similarly, Natalie D. Ramsey was included in the Top 50: 2021 Women Pennsylvania Super Lawyers list. Read more in the press release.

Robinson+Cole Expands Health Law Practice with Partner Addition in New York

Robinson+Cole is pleased to announce the addition of Danielle H. Tangorre as a partner in the firm’s Health Law Group. Danielle represents and advises a broad range of health care providers and trade associations on transactional matters, litigation, operational and compliance issues, fraud and abuse, HIPAA, and regulatory matters. Her addition expands Robinson+Cole’s legal practice in Albany, New York, where the firm also has a significant government relations practice.

“Danielle has impressive experience and I’m delighted to welcome her to our team,” said Rhonda J. Tobin, Managing Partner, Robinson+Cole. “Continuing to expand the depth and geographical diversity of our health law practice is another step in the execution of our strategic plan to expand some of our strongest practices in our most strategic locations. The firm continues to look for growth opportunities in these practices, as well as in the large commercial centers where we have offices, including New York, Boston, Philadelphia, Wilmington and Miami.” Read more in the press release.