Stacey L. Gulick
Partner
516-393-2264
Telemedicine
- Overview
- Attorneys
- Insights
Telemedicine is changing the delivery of health care in many exciting ways and presenting new opportunities and challenges. Our health care attorneys provide updated advice on telehealth models of care, guide investment and expansion of telemedicine companies, and help clients navigate the ever-changing regulatory landscape. This includes securing reimbursement, completing complex transactions in the telehealth space, and properly structuring innovative and managed care arrangements with third parties. Our clients operate in many different clinical areas including mental health, primary health, and orthopedics.
Working together across diverse Garfunkel Wild legal groups, our health care attorneys provide a range of services to our clients in the telemedicine and telehealth space, including advising on:
- Arrangements between telehealth providers and insurers and other third parties including government payors
- Licensure and practice of medicine issues arising under state laws, including those involving informed consent, prescribing, practitioner supervision, and more
- Reviewing Telehealth service delivery models
- Health care fraud and abuse laws applicable to telehealth services and digital technology offerings
- Application of privacy and data security laws
- Negotiations of vendor and technology relationships
Practice Group Contacts
Team
Post-Shutdown Telehealth Guidance
As we explained in our previous client alert, at the time the government shutdown ended, it was unclear whether Medicare telehealth services provided during that time (October 1 through November 12, 2025) would be reimbursed. CMS has since issued updated guidance.
NEW TELEHEALTH UPDATE: Medicare Waivers Extended to January 30, 2026
Congress has once again temporarily extended key Medicare telehealth flexibilities, this time through January 30, 2026.
FDA Seeks Comment on AI-Enabled Medical Devices
The U.S. Food and Drug Administration (FDA) has issued a Request for Public Comment to gather feedback on practical approaches for measuring and evaluating the performance of AI-enabled medical devices in real-world clinical settings to help the FDA ensure such medical devices remain safe and effective throughout their life cycle. This move underscores the FDA’s increasing focus on post-market oversight of AI technologies, including generative AI, and their evolving behavior in dynamic healthcare environments.
OIG Allows Grants to Offset Therapy Costs
Access to and the cost of health care for children with complex medical needs is a significant burden for many families. Grants can serve as an important lifeline that allows families to obtain and afford medically necessary and appropriate care for their children. The U.S. Department of Health and Human Services, Office of Inspector General’s (OIG) favorable advisory opinion (25-10) is another positive step towards ensuring that children with special medical needs receive timely and affordable care.
OIG Scrutinizes Remote Patient Monitoring
As remote patient monitoring (RPM) continues to grow in popularity, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) is keeping close watch on how providers are billing, coding, and documenting these services.
OIG Rejects Payments for Exclusion Screenings
OIG recently rejected a medical device company’s (Company) novel proposal to pay a third-party (Screener) to perform exclusion screenings of the Company for the Company’s customers. OIG’s unfavorable Advisory Opinion (25-04) determined that this proposed arrangement (Arrangement) implicates the Federal Anti-Kickback Statute and raises concerns about inappropriate steering and anti-competitiveness.
OIG Approves Telehealth Arrangement for Leased Employees
The U.S. Department of Health and Human Services, Office of Inspector General (OIG), recently issued a favorable Advisory Opinion (25-03) regarding a proposed arrangement (Arrangement) where a non-clinical management support organization and an affiliated professional corporation wholly owned by physician shareholders (PC) enters into lease agreements with telehealth platforms (Platforms) and providers employed by or contracted with these Platforms (Platform Providers).
OIG Report Identifies Emerging Priorities
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) recently released its Semiannual Report (SAR) covering the period October 1, 2024 to March 31, 2025. The SAR is a must-read because it identifies a wide array of risk areas, which will undoubtedly help providers modify their own risk assessments and audit work plans to stay ahead of government regulators in the ongoing fight against fraud, waste, and abuse.
Connecticut Court Holds Providers Can Sue to Enforce NSA IDR Awards
On May 14, 2025, Judge Michael P. Shea of the Connecticut District Court soundly rejected the Texas NSA decision, and held that “the NSA creates a private cause of action to enforce IDR awards.”
NY DOH Publishes FAQs Regarding Reporting of Health Care Transactions
In March, the New York Department of Health (DOH) published “frequently asked questions” (FAQs) related to the law that requires “health care entities” party to a “material transaction” to report the transaction to the DOH in advance.
New Telehealth Update: Medicare Waivers Extended To September 30, 2025
Congress has once again extended certain telehealth flexibilities until September 30, 2025 (which coincides with the end of the Congressional fiscal year).
Marketing Arrangements in Medicare Advantage Plans Under OIG Scrutiny
On December 11, 2024, the U.S. Department of Health and Human Services, Office of the Inspector General (OIG) published a Special Fraud Alert in response to the uptick in abusive marketing practices between Medicare Advantage Organizations (MAOs), health care providers, and ancillary participants (such as agents and brokers).
New York Proposes More Scrutiny for Health Care Transactions
On January 21, 2025, New York Governor Kathy Hochul released the proposed FY 2026 New York State Executive Budget, which includes enhanced scrutiny of material transactions involving health care entities.
Second Circuit Adopts “One Purpose” Test
The United States Court of Appeals for the Second Circuit (Second Circuit or Court), which has Federal jurisdiction in Connecticut, New York, and Vermont, recently issued an important decision regarding health care provider liability under the False Claims Act (FCA) when a whistleblower alleges a violation of the Anti-Kickback Statute (AKS). The Second Circuit explicitly adopted the “one purpose” test for the first time to determine whether a financial arrangement between a provider and a referral source violates the AKS, and thus potentially subjects the parties to substantial fines and penalties under the FCA.
UPDATED: Medicare Telehealth Waivers Extended to March 31, 2025
We previously reported that Congress issued stopgap government funding legislation that extended current telehealth waivers and flexibilities through December 31, 2026. However, as a result of unrelated 11th hour political negotiations, the initial proposed legislation containing the full two-year extension was withdrawn. On December 20, 2024, Congress passed the American Relief Act 2025 (“H.R. 10545”), which was signed into law by President Biden on December 21, 2024.
Medicare Telehealth Waivers – Status Unknown
We previously let you know that the Medicare telehealth waivers would be extended based upon Congressional action. Unfortunately, at the 11th hour, the waivers did not go through and there has been much vacillation about next steps by Congress. Therefore, the status of the Medicare telehealth waivers remains unclear. We are monitoring the situation, and will keep you updated when we learn anything definitive.
New DOJ Report: Providers Beware
Last week, the U.S. Department of Justice (DOJ) and the U.S. Department of Health and Human Services (HHS) released its annual, jointly authored Health Care Fraud and Abuse Control Program Report (the Report) for Fiscal Year 2023.
New OIG Priorities Emerge in Report
The U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG) released its Semiannual Report (SAR) to Congress on December 4, 2024.
The Brave New World of Telehealth Post COVID – What You Need to Know
Garfunkel Wild’s Stacey L. Gulick and Kathleen M. Brown will present the webinar “The Brave New World of Telehealth Post COVID - What You Need to Know ” on December 12, 2024, from 12:00 PM – 1:00 PM ET.
OIG Highlights New Concerns
This week, the U.S. Department of Health and Human Services (“HHS”), Office of Inspector General (“OIG”) fulfilled its annual statutory obligation by releasing its 2024 Top Management and Performance Challenges Report (the “Report”). Historically, the Report has not attracted widespread interest in the provider community because it largely focuses on HHS operational challenges. Importantly for providers and other stakeholders, however, the Report reveals crucial insights about compliance priorities for the year ahead.
DEA Extends Telemedicine Prescription Rules Through 2025
The Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) have jointly issued a third emergency extension allowing health care practitioners to prescribe Schedule II-V controlled substances via audio-video telemedicine encounters without an initial in-person evaluation. This extension, effective from January 1, 2025 through December 31, 2025, also provides the DEA with additional time to finalize permanent regulations for prescribing controlled substances through telemedicine.
OIG Approves Patient Travel, but Not Fertility Services
OIG posted a partially favorable Advisory Opinion (24-05) permitting a biotechnology company to provide transportation, lodging, and payment of associated expenses for certain patients receiving gene therapy treatments for two severe genetic diseases. In the same Advisory Opinion, however, OIG responded unfavorably to the Company’s proposal to subsidize some or all costs related to fertility preservation and storage procedures for these same patients.
OIG Report Highlights Enforcement Priorities
The U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG) released its revamped Semiannual Report (SAR) on June 3, 2024. The SAR’s new format focuses on the oversight work OIG completed during the reporting period, and emphasizes how this work directly addresses the Top Management Challenges Facing HHS.
Telehealth Update: NY Proposes Controlled Substance Prescribing, Waiting on DEA
On May 15, 2024, the New York State Department of Health (DOH) announced a pivotal change in its regulations, as it intends to permit health care providers to use telemedicine to conduct patient evaluations before prescribing controlled substances. Prior to the COVID-19 pandemic, DOH required health care providers to perform an initial in-person physical evaluation of patients before prescribing controlled substances.
Be Prepared! NYS OMIG’s 2024 Work Plan Provides an Audit Roadmap for Health Care Providers of All Types
Garfunkel’s Compliance Webinar Series rolls on with an examination of the 2024 Work Plan published by the New York State Office of Medicaid Inspector General (OMIG).
FTC Bans Non-Competes Across the Nation
On Tuesday, April 23, 2024, the Federal Trade Commission (FTC) promulgated a final rule banning most non-compete agreements, in any industry, and is set to become effective 120 days after its publication in the Federal Register (the “Final Rule”).
OIG Issues New Resource for Single Audits
The United States Department of Health and Human Services (HHS), Office of Inspector General (OIG) recently posted a new educational resource on its website about Single Audits. HHS is the largest grant-making agency in the Federal government, and OIG’s new resource is designed to help key stakeholders understand the scope of Single Audits, as well as improve the overall quality of such audits.
New York OMIG Updates Self-Disclosure Guidance
The New York State Office of the Medicaid Inspector General (OMIG) recently updated its Self-Disclosure Guidance and Frequently Asked Questions (collectively, “Updates”). These Updates give participating providers and entities additional insight into how to report overpayments involving unresponsive Medicaid Managed Care Organizations (MMCOs) or multiple entities, as well as those that are untimely, have adjusted or voided claims, or lost or damaged records.
OMIG’s 2024 Work Plan Gives Critical Insights into Program Integrity Initiatives
The New York State Office of the Medicaid Inspector General (OMIG) released its 2024 work plan in furtherance of its mission to coordinate and conduct activities to prevent, detect and investigate medical assistance program fraud, waste and abuse, and to recover improperly expended Medicaid funds.
OIG Approves Creative Approach to Restructuring Medical Practice Partnerships
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (23-12) that allows a limited liability partnership (the Partnership) consisting of two classes of physician partners to make a one-time, voluntary redemption offer (offer) to individual partners when they reach age 67.
More Provider “Nuggets” From OIG’s Year-End Reporting Blitz
Continuing its year-end reporting blitz, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Semiannual Report (SAR) to Congress on December 1, 2023.
OIG Provides Roadmap to Hot-Button Issues
The OIG fulfilled its annual statutory obligation by releasing its Top Management and Performance Challenges (TMC) document. Providers should take note because the document provides important insight into the specific areas over which HHS (and the OIG) will remain focused.
OIG Releases New General Compliance Program Reference Guide
On November 6, 2023, the OIG released its General Compliance Program Guidance, the first in a series of new, non-binding reference guides designed to share information with health care compliance professionals and other health care industry stakeholders
DEA Proposes Temporary Rule that Impacts In-Person Requirements
The Federal Drug Enforcement Administration (“DEA”) announced that it has submitted a draft temporary rule to extend the COVID-19 PHE flexibilities around prescribing controlled substances (the “Temporary Rule”).
HHS-OIG Issues Telemedicine Special Fraud Alert
The Department of Health and Human Services, Office of the Inspector General (“OIG”) published a Special Fraud Alert regarding arrangements with telemedicine companies. According to the OIG, it investigated dozens of fraud schemes involving companies that purported to provide telehealth, telemedicine, or telemarketing services (collectively, “Telemedicine Companies”).
Garfunkel Wild Webinar – Federal No Surprises Act – One Month In. What Have We Learned? What Questions Remain?
Garfunkel Wild’s Debra Silverman and John Martin will present the webinar “Federal No Surprises Act – One month in. What have we learned? What questions remain?" on February 1, 2022, from 12:00 pm – 1:00 pm (EST).
Behavioral Health News Webinar “This Will Only Hurt a Little – Stoicism in the Face of EHR Implementations”
Garfunkel Wild Partner Terence Russo will present at Behavioral Health News Webinar “This Will Only Hurt a Little – Stoicism in the Face of EHR Implementations” on October 13, 2021 from 1:00 pm – 2:00 pm EDT.
New York City Bar Webcast – Telehealth 2021 – Rapid Legal Changes and the Implications Resulting from the COVID-19 Pandemic
Garfunkel Wild Partner, Stacey Gulick, will present at the New York City Bar Webcast – Telehealth 2021 – Rapid Legal Changes and the Implications Resulting from the COVID-19 Pandemic on May 4, 2021.
OIG Issues Important New And Revised Safe Harbors
The United States Department of Health and Human Services (“HHS”), Office of Inspector General (“OIG”) recently issued an important final rule (the “Final Rule”) that makes significant changes to existing “Safe Harbors” under the Federal Anti-kickback Statue (“AKS”) and that adds new Safe Harbors that provide protection from AKS sanctions for certain types of arrangements.
CMS Makes Sweeping Changes to Telehealth Rules during COVID-19 Pandemic
CMS has again made significant changes to the current rules and regulations in response to the public health emergency related to the COVID-19 pandemic (PHE). Among the litany of evolving rule modifications, CMS has provided greater flexibility regarding the provision of telehealth and other services in order to provide patients and clinicians with the ability to access and deliver safe patient care during the PHE.
Garfunkel Wild Webinar – Nursing Facility Update: 1135 Waivers and NYS Executive Orders Explained Emergency Treatment Protection Act (Immunity) and Telehealth Expansion
Garfunkel Wild’s Eve Green Koopersmith will present the webinar “Nursing Facility Update: 1135 Waivers and NYS Executive Orders Explained Emergency Treatment Protection Act (Immunity) And Telehealth Expansion” on April 21, 2020.
FCC Establishes New COVID-19 Telehealth Program
The Federal Communications Commission (FCC) has issued a new emergency program – the COVID-19 Telehealth Program (Program) – to provide eligible health care providers with funding of up to $1 million to maximize the provision of connected care services (e.g., telehealth) during the pandemic. Following is a brief overview of the Program and its requirements.
Garfunkel Wild Webinar – COVID-19 Telehealth Rules Applicable to FQHCs
Garfunkel Wild’s Jeff Adest and Sandra Jensen will present the webinar “COVID-19 Telehealth Rules Applicable to FQHCs” on March 26, 2020.
Garfunkel Wild Webinar – Implementing and Expanding Telehealth to Address COVID-19
Garfunkel Wild Partner/Director Debra A. Silverman and Partners Stacey L. Gulick and Sandra M. Jensen will present the webinar “Implementing and Expanding Telehealth to Address COVID-19” on March 19, 2020.
Garfunkel Wild Webinar – “Telehealth: Effective Risk Management Strategies to Reduce Liability”
Garfunkel Wild Partner/Directors Barry Cepelewicz will present the webinar “Telehealth: Effective Risk Management Strategies to Reduce Liability” on February 26, 2020. This webinar is the first of our Telehealth webinar series.
2019 ASC and Healthcare Management Pre-Symposium Webinar: Resolving Payer Obstacles
Garfunkel Wild Partner/Director Debra A. Silverman and will be joined by Garfunkel Health Advisors to present a complimentary webinar entitled “Resolving Payer Obstacles.”
The Gitenstein Institute for Health Law & Policy at Hofstra University School of Law – Thought Leadership In Action Speaker Series
Judith A. Eisen and Stacey L. Gulick present at the Gitenstein Institute For Health Law & Policy At Hofstra University School of Law – Thought Leadership in Action Speaker Series on April 4, 2019.
Fairfield County Medical Association’s Webinar– Creating a Medical Record that Protects Your Patients, Your Practice and You
Barry B. Cepelewicz will present at the Fairfield County Medical Association’s Webinar – Creating a Medical Record that Protects Your Patients, Your Practice & You – March 6, 2019.
Telemedicine is changing the delivery of health care in many exciting ways and presenting new opportunities and challenges. Our health care attorneys provide updated advice on telehealth models of care, guide investment and expansion of telemedicine companies, and help clients navigate the ever-changing regulatory landscape. This includes securing reimbursement, completing complex transactions in the telehealth space, and properly structuring innovative and managed care arrangements with third parties. Our clients operate in many different clinical areas including mental health, primary health, and orthopedics.
Working together across diverse Garfunkel Wild legal groups, our health care attorneys provide a range of services to our clients in the telemedicine and telehealth space, including advising on:
- Arrangements between telehealth providers and insurers and other third parties including government payors
- Licensure and practice of medicine issues arising under state laws, including those involving informed consent, prescribing, practitioner supervision, and more
- Reviewing Telehealth service delivery models
- Health care fraud and abuse laws applicable to telehealth services and digital technology offerings
- Application of privacy and data security laws
- Negotiations of vendor and technology relationships
Practice Group Contacts
Team
Post-Shutdown Telehealth Guidance
As we explained in our previous client alert, at the time the government shutdown ended, it was unclear whether Medicare telehealth services provided during that time (October 1 through November 12, 2025) would be reimbursed. CMS has since issued updated guidance.
NEW TELEHEALTH UPDATE: Medicare Waivers Extended to January 30, 2026
Congress has once again temporarily extended key Medicare telehealth flexibilities, this time through January 30, 2026.
FDA Seeks Comment on AI-Enabled Medical Devices
The U.S. Food and Drug Administration (FDA) has issued a Request for Public Comment to gather feedback on practical approaches for measuring and evaluating the performance of AI-enabled medical devices in real-world clinical settings to help the FDA ensure such medical devices remain safe and effective throughout their life cycle. This move underscores the FDA’s increasing focus on post-market oversight of AI technologies, including generative AI, and their evolving behavior in dynamic healthcare environments.
OIG Allows Grants to Offset Therapy Costs
Access to and the cost of health care for children with complex medical needs is a significant burden for many families. Grants can serve as an important lifeline that allows families to obtain and afford medically necessary and appropriate care for their children. The U.S. Department of Health and Human Services, Office of Inspector General’s (OIG) favorable advisory opinion (25-10) is another positive step towards ensuring that children with special medical needs receive timely and affordable care.
OIG Scrutinizes Remote Patient Monitoring
As remote patient monitoring (RPM) continues to grow in popularity, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) is keeping close watch on how providers are billing, coding, and documenting these services.
OIG Rejects Payments for Exclusion Screenings
OIG recently rejected a medical device company’s (Company) novel proposal to pay a third-party (Screener) to perform exclusion screenings of the Company for the Company’s customers. OIG’s unfavorable Advisory Opinion (25-04) determined that this proposed arrangement (Arrangement) implicates the Federal Anti-Kickback Statute and raises concerns about inappropriate steering and anti-competitiveness.
OIG Approves Telehealth Arrangement for Leased Employees
The U.S. Department of Health and Human Services, Office of Inspector General (OIG), recently issued a favorable Advisory Opinion (25-03) regarding a proposed arrangement (Arrangement) where a non-clinical management support organization and an affiliated professional corporation wholly owned by physician shareholders (PC) enters into lease agreements with telehealth platforms (Platforms) and providers employed by or contracted with these Platforms (Platform Providers).
OIG Report Identifies Emerging Priorities
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) recently released its Semiannual Report (SAR) covering the period October 1, 2024 to March 31, 2025. The SAR is a must-read because it identifies a wide array of risk areas, which will undoubtedly help providers modify their own risk assessments and audit work plans to stay ahead of government regulators in the ongoing fight against fraud, waste, and abuse.
Connecticut Court Holds Providers Can Sue to Enforce NSA IDR Awards
On May 14, 2025, Judge Michael P. Shea of the Connecticut District Court soundly rejected the Texas NSA decision, and held that “the NSA creates a private cause of action to enforce IDR awards.”
NY DOH Publishes FAQs Regarding Reporting of Health Care Transactions
In March, the New York Department of Health (DOH) published “frequently asked questions” (FAQs) related to the law that requires “health care entities” party to a “material transaction” to report the transaction to the DOH in advance.
New Telehealth Update: Medicare Waivers Extended To September 30, 2025
Congress has once again extended certain telehealth flexibilities until September 30, 2025 (which coincides with the end of the Congressional fiscal year).
Marketing Arrangements in Medicare Advantage Plans Under OIG Scrutiny
On December 11, 2024, the U.S. Department of Health and Human Services, Office of the Inspector General (OIG) published a Special Fraud Alert in response to the uptick in abusive marketing practices between Medicare Advantage Organizations (MAOs), health care providers, and ancillary participants (such as agents and brokers).
New York Proposes More Scrutiny for Health Care Transactions
On January 21, 2025, New York Governor Kathy Hochul released the proposed FY 2026 New York State Executive Budget, which includes enhanced scrutiny of material transactions involving health care entities.
Second Circuit Adopts “One Purpose” Test
The United States Court of Appeals for the Second Circuit (Second Circuit or Court), which has Federal jurisdiction in Connecticut, New York, and Vermont, recently issued an important decision regarding health care provider liability under the False Claims Act (FCA) when a whistleblower alleges a violation of the Anti-Kickback Statute (AKS). The Second Circuit explicitly adopted the “one purpose” test for the first time to determine whether a financial arrangement between a provider and a referral source violates the AKS, and thus potentially subjects the parties to substantial fines and penalties under the FCA.
UPDATED: Medicare Telehealth Waivers Extended to March 31, 2025
We previously reported that Congress issued stopgap government funding legislation that extended current telehealth waivers and flexibilities through December 31, 2026. However, as a result of unrelated 11th hour political negotiations, the initial proposed legislation containing the full two-year extension was withdrawn. On December 20, 2024, Congress passed the American Relief Act 2025 (“H.R. 10545”), which was signed into law by President Biden on December 21, 2024.
Medicare Telehealth Waivers – Status Unknown
We previously let you know that the Medicare telehealth waivers would be extended based upon Congressional action. Unfortunately, at the 11th hour, the waivers did not go through and there has been much vacillation about next steps by Congress. Therefore, the status of the Medicare telehealth waivers remains unclear. We are monitoring the situation, and will keep you updated when we learn anything definitive.
New DOJ Report: Providers Beware
Last week, the U.S. Department of Justice (DOJ) and the U.S. Department of Health and Human Services (HHS) released its annual, jointly authored Health Care Fraud and Abuse Control Program Report (the Report) for Fiscal Year 2023.
New OIG Priorities Emerge in Report
The U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG) released its Semiannual Report (SAR) to Congress on December 4, 2024.
The Brave New World of Telehealth Post COVID – What You Need to Know
Garfunkel Wild’s Stacey L. Gulick and Kathleen M. Brown will present the webinar “The Brave New World of Telehealth Post COVID - What You Need to Know ” on December 12, 2024, from 12:00 PM – 1:00 PM ET.
OIG Highlights New Concerns
This week, the U.S. Department of Health and Human Services (“HHS”), Office of Inspector General (“OIG”) fulfilled its annual statutory obligation by releasing its 2024 Top Management and Performance Challenges Report (the “Report”). Historically, the Report has not attracted widespread interest in the provider community because it largely focuses on HHS operational challenges. Importantly for providers and other stakeholders, however, the Report reveals crucial insights about compliance priorities for the year ahead.
DEA Extends Telemedicine Prescription Rules Through 2025
The Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) have jointly issued a third emergency extension allowing health care practitioners to prescribe Schedule II-V controlled substances via audio-video telemedicine encounters without an initial in-person evaluation. This extension, effective from January 1, 2025 through December 31, 2025, also provides the DEA with additional time to finalize permanent regulations for prescribing controlled substances through telemedicine.
OIG Approves Patient Travel, but Not Fertility Services
OIG posted a partially favorable Advisory Opinion (24-05) permitting a biotechnology company to provide transportation, lodging, and payment of associated expenses for certain patients receiving gene therapy treatments for two severe genetic diseases. In the same Advisory Opinion, however, OIG responded unfavorably to the Company’s proposal to subsidize some or all costs related to fertility preservation and storage procedures for these same patients.
OIG Report Highlights Enforcement Priorities
The U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG) released its revamped Semiannual Report (SAR) on June 3, 2024. The SAR’s new format focuses on the oversight work OIG completed during the reporting period, and emphasizes how this work directly addresses the Top Management Challenges Facing HHS.
Telehealth Update: NY Proposes Controlled Substance Prescribing, Waiting on DEA
On May 15, 2024, the New York State Department of Health (DOH) announced a pivotal change in its regulations, as it intends to permit health care providers to use telemedicine to conduct patient evaluations before prescribing controlled substances. Prior to the COVID-19 pandemic, DOH required health care providers to perform an initial in-person physical evaluation of patients before prescribing controlled substances.
Be Prepared! NYS OMIG’s 2024 Work Plan Provides an Audit Roadmap for Health Care Providers of All Types
Garfunkel’s Compliance Webinar Series rolls on with an examination of the 2024 Work Plan published by the New York State Office of Medicaid Inspector General (OMIG).
FTC Bans Non-Competes Across the Nation
On Tuesday, April 23, 2024, the Federal Trade Commission (FTC) promulgated a final rule banning most non-compete agreements, in any industry, and is set to become effective 120 days after its publication in the Federal Register (the “Final Rule”).
OIG Issues New Resource for Single Audits
The United States Department of Health and Human Services (HHS), Office of Inspector General (OIG) recently posted a new educational resource on its website about Single Audits. HHS is the largest grant-making agency in the Federal government, and OIG’s new resource is designed to help key stakeholders understand the scope of Single Audits, as well as improve the overall quality of such audits.
New York OMIG Updates Self-Disclosure Guidance
The New York State Office of the Medicaid Inspector General (OMIG) recently updated its Self-Disclosure Guidance and Frequently Asked Questions (collectively, “Updates”). These Updates give participating providers and entities additional insight into how to report overpayments involving unresponsive Medicaid Managed Care Organizations (MMCOs) or multiple entities, as well as those that are untimely, have adjusted or voided claims, or lost or damaged records.
OMIG’s 2024 Work Plan Gives Critical Insights into Program Integrity Initiatives
The New York State Office of the Medicaid Inspector General (OMIG) released its 2024 work plan in furtherance of its mission to coordinate and conduct activities to prevent, detect and investigate medical assistance program fraud, waste and abuse, and to recover improperly expended Medicaid funds.
OIG Approves Creative Approach to Restructuring Medical Practice Partnerships
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (23-12) that allows a limited liability partnership (the Partnership) consisting of two classes of physician partners to make a one-time, voluntary redemption offer (offer) to individual partners when they reach age 67.
More Provider “Nuggets” From OIG’s Year-End Reporting Blitz
Continuing its year-end reporting blitz, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Semiannual Report (SAR) to Congress on December 1, 2023.
OIG Provides Roadmap to Hot-Button Issues
The OIG fulfilled its annual statutory obligation by releasing its Top Management and Performance Challenges (TMC) document. Providers should take note because the document provides important insight into the specific areas over which HHS (and the OIG) will remain focused.
OIG Releases New General Compliance Program Reference Guide
On November 6, 2023, the OIG released its General Compliance Program Guidance, the first in a series of new, non-binding reference guides designed to share information with health care compliance professionals and other health care industry stakeholders
DEA Proposes Temporary Rule that Impacts In-Person Requirements
The Federal Drug Enforcement Administration (“DEA”) announced that it has submitted a draft temporary rule to extend the COVID-19 PHE flexibilities around prescribing controlled substances (the “Temporary Rule”).
HHS-OIG Issues Telemedicine Special Fraud Alert
The Department of Health and Human Services, Office of the Inspector General (“OIG”) published a Special Fraud Alert regarding arrangements with telemedicine companies. According to the OIG, it investigated dozens of fraud schemes involving companies that purported to provide telehealth, telemedicine, or telemarketing services (collectively, “Telemedicine Companies”).
Garfunkel Wild Webinar – Federal No Surprises Act – One Month In. What Have We Learned? What Questions Remain?
Garfunkel Wild’s Debra Silverman and John Martin will present the webinar “Federal No Surprises Act – One month in. What have we learned? What questions remain?" on February 1, 2022, from 12:00 pm – 1:00 pm (EST).
Behavioral Health News Webinar “This Will Only Hurt a Little – Stoicism in the Face of EHR Implementations”
Garfunkel Wild Partner Terence Russo will present at Behavioral Health News Webinar “This Will Only Hurt a Little – Stoicism in the Face of EHR Implementations” on October 13, 2021 from 1:00 pm – 2:00 pm EDT.
New York City Bar Webcast – Telehealth 2021 – Rapid Legal Changes and the Implications Resulting from the COVID-19 Pandemic
Garfunkel Wild Partner, Stacey Gulick, will present at the New York City Bar Webcast – Telehealth 2021 – Rapid Legal Changes and the Implications Resulting from the COVID-19 Pandemic on May 4, 2021.
OIG Issues Important New And Revised Safe Harbors
The United States Department of Health and Human Services (“HHS”), Office of Inspector General (“OIG”) recently issued an important final rule (the “Final Rule”) that makes significant changes to existing “Safe Harbors” under the Federal Anti-kickback Statue (“AKS”) and that adds new Safe Harbors that provide protection from AKS sanctions for certain types of arrangements.
CMS Makes Sweeping Changes to Telehealth Rules during COVID-19 Pandemic
CMS has again made significant changes to the current rules and regulations in response to the public health emergency related to the COVID-19 pandemic (PHE). Among the litany of evolving rule modifications, CMS has provided greater flexibility regarding the provision of telehealth and other services in order to provide patients and clinicians with the ability to access and deliver safe patient care during the PHE.
Garfunkel Wild Webinar – Nursing Facility Update: 1135 Waivers and NYS Executive Orders Explained Emergency Treatment Protection Act (Immunity) and Telehealth Expansion
Garfunkel Wild’s Eve Green Koopersmith will present the webinar “Nursing Facility Update: 1135 Waivers and NYS Executive Orders Explained Emergency Treatment Protection Act (Immunity) And Telehealth Expansion” on April 21, 2020.
FCC Establishes New COVID-19 Telehealth Program
The Federal Communications Commission (FCC) has issued a new emergency program – the COVID-19 Telehealth Program (Program) – to provide eligible health care providers with funding of up to $1 million to maximize the provision of connected care services (e.g., telehealth) during the pandemic. Following is a brief overview of the Program and its requirements.
Garfunkel Wild Webinar – COVID-19 Telehealth Rules Applicable to FQHCs
Garfunkel Wild’s Jeff Adest and Sandra Jensen will present the webinar “COVID-19 Telehealth Rules Applicable to FQHCs” on March 26, 2020.
Garfunkel Wild Webinar – Implementing and Expanding Telehealth to Address COVID-19
Garfunkel Wild Partner/Director Debra A. Silverman and Partners Stacey L. Gulick and Sandra M. Jensen will present the webinar “Implementing and Expanding Telehealth to Address COVID-19” on March 19, 2020.
Garfunkel Wild Webinar – “Telehealth: Effective Risk Management Strategies to Reduce Liability”
Garfunkel Wild Partner/Directors Barry Cepelewicz will present the webinar “Telehealth: Effective Risk Management Strategies to Reduce Liability” on February 26, 2020. This webinar is the first of our Telehealth webinar series.
2019 ASC and Healthcare Management Pre-Symposium Webinar: Resolving Payer Obstacles
Garfunkel Wild Partner/Director Debra A. Silverman and will be joined by Garfunkel Health Advisors to present a complimentary webinar entitled “Resolving Payer Obstacles.”
The Gitenstein Institute for Health Law & Policy at Hofstra University School of Law – Thought Leadership In Action Speaker Series
Judith A. Eisen and Stacey L. Gulick present at the Gitenstein Institute For Health Law & Policy At Hofstra University School of Law – Thought Leadership in Action Speaker Series on April 4, 2019.
Fairfield County Medical Association’s Webinar– Creating a Medical Record that Protects Your Patients, Your Practice and You
Barry B. Cepelewicz will present at the Fairfield County Medical Association’s Webinar – Creating a Medical Record that Protects Your Patients, Your Practice & You – March 6, 2019.