Kathleen M. Brown
Kathleen M. Brown
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Kathleen (“Kat”) Brown advises clients on a broad spectrum of regulatory and compliance matters in the highly regulated health care sector.
She assists health care providers, organizations, and stakeholders in navigating complex regulatory frameworks, including federal and state anti-referral laws, HIPAA compliance, and fee splitting and corporate practice of medicine (CPOM) rules. Kat also counsels clients on licensure and scope of practice issues, telehealth and remote patient monitoring, and regulatory concerns related to pharmaceuticals and medical devices, including 340B Program compliance. In addition to her regulatory work, Kat frequently performs health care diligence in large transactions, including mergers and acquisitions, helping clients address compliance and risk management issues throughout the process.
Kat also advises nonprofit and charitable organizations at every stage of their lifecycle, from formation and tax exemption to day-to-day operations, governance, and dissolution. She assists organizations and their boards in implementing strong internal controls and compliance policies to meet legal and fiduciary obligations.
Before joining the firm, Kat gained extensive experience in private practice, New York State government, government relations, and health care consulting. This diverse background provides her with a deep understanding of the regulatory landscape and empowers her to advocate effectively for clients across both public and private sectors.
Super Lawyers has recognized Garfunkel Wild Attorneys across a range of the firm’s practice areas to the 2025 Super Lawyers and Rising Stars list.
Garfunkel Wild attorneys have once again been selected by their peers for inclusion in the 2023 edition of Super Lawyers.
Thirty-Eight Garfunkel Wild attorneys were selected by their peers for inclusion in the 2024 editions of The Best Lawyers in America and The Best Lawyers: Ones to Watch.
Thirty-Three Garfunkel Wild attorneys were selected by their peers for inclusion in 2022 New York Metro Super Lawyers, and 2022 New York Metro/Upstate New York Rising Stars.
Thirty-Six Garfunkel Wild attorneys were selected by their peers for inclusion in 2021 New York Metro Super Lawyers, and 2021 New York Metro/Upstate New York Rising Stars.
Garfunkel Wild, P.C., a premier law firm with a specialty in health law, is pleased to announce the formal launch of the firm’s multi-disciplinary Cannabis Law Practice Group to help clients navigate the rapidly evolving cannabis landscape and conflicting federal, state, and local laws and regulations.
Thirty-Six Garfunkel Wild attorneys were selected by their peers for inclusion in 2020 New York Metro Super Lawyers, and 2020 New York Metro/Upstate Rising Stars.
Garfunkel Wild received prominent recognition in the 2025 editions of The Best Lawyers in America and The Best Lawyers in America: Ones to Watch. A total of 38 attorneys were honored with 59 individual recognitions across various practices and offices nationwide. Additionally, 3 Garfunkel Wild attorneys were distinguished as Lawyer of the Year, an accolade awarded to only one […]
Super Lawyers has recognized 36 Garfunkel Wild Attorneys across a range of the firm’s practice areas to the 2024 Super Lawyers and Rising Stars list.
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.
Congress has once again temporarily extended key Medicare telehealth flexibilities, this time through January 30, 2026.
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.
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.
On August 1, 2025, the Health Resources and Services Administration issued a new pilot initiative under the 340B Drug Pricing Program that may significantly reshape longstanding pricing and discount frameworks. The 340B Rebate Model Pilot Program will allow participating drug manufacturers to offer post-sale, rebates to eligible 340B Covered Entities for select drugs, rather than providing upfront discounts.
On July 23, 2025, the United States Department of Health and Human Services, Office of Civil Rights (“OCR”) announced a $250,000 settlement with the Specialty Surgery Center of Central New York (the “Surgery Center”) as a result of a ransomware attack involving the PYSA ransomware variant, which is known to target the healthcare industry.
Garfunkel Wild's Stacey L. Gulick, Kathleen M. Brown, and Alison T. Schimel will present the webinar "Starting the Patient Journey: Essential Documentation for Treatment and Payment" on April 16, 2025, from 12:00 PM - 1:00 PM ET.
Congress has once again extended certain telehealth flexibilities until September 30, 2025 (which coincides with the end of the Congressional fiscal year).
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.
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.
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.
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.
On October 12, 2024, the New York State Department of Health (“DOH”) published the final cybersecurity regulations for general hospitals (the “Regulations”), with some provisions effective immediately.
Andrew E. Blustein and Kathleen M. Brown will present "Compliance and Governance: Maintaining Operational Excellence for FQHCs" at the 2024 New Jersey Primary Care Association (“NJPCA”) Annual Conference, on October 10th.
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.
The HIPAA Privacy Rule to Support Reproductive Health Care Privacy was recently announced as a final rule that becomes effective on June 25, 2024 (the “Final Rule”).
On March 9, 2024, CMS announced it will make available Change Healthcare/Optum Payment Disruption accelerated payments to providers experiencing potentially significant cash-flow problems as a result of the cyberattack on UnitedHealth Group’s subsidiary Change Healthcare/Optum .
Additional speaking & writing
Publications
- Authored chapters entitled “Immunizations” and “Issues Involving Infectious Diseases” in the Legal Manual for New York Physicians (Sixth Edition)
Kathleen (“Kat”) Brown advises clients on a broad spectrum of regulatory and compliance matters in the highly regulated health care sector.
She assists health care providers, organizations, and stakeholders in navigating complex regulatory frameworks, including federal and state anti-referral laws, HIPAA compliance, and fee splitting and corporate practice of medicine (CPOM) rules. Kat also counsels clients on licensure and scope of practice issues, telehealth and remote patient monitoring, and regulatory concerns related to pharmaceuticals and medical devices, including 340B Program compliance. In addition to her regulatory work, Kat frequently performs health care diligence in large transactions, including mergers and acquisitions, helping clients address compliance and risk management issues throughout the process.
Kat also advises nonprofit and charitable organizations at every stage of their lifecycle, from formation and tax exemption to day-to-day operations, governance, and dissolution. She assists organizations and their boards in implementing strong internal controls and compliance policies to meet legal and fiduciary obligations.
Before joining the firm, Kat gained extensive experience in private practice, New York State government, government relations, and health care consulting. This diverse background provides her with a deep understanding of the regulatory landscape and empowers her to advocate effectively for clients across both public and private sectors.
Congress has once again temporarily extended key Medicare telehealth flexibilities, this time through January 30, 2026.
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.
The HIPAA Privacy Rule to Support Reproductive Health Care Privacy was recently announced as a final rule that becomes effective on June 25, 2024 (the “Final Rule”).
On March 9, 2024, CMS announced it will make available Change Healthcare/Optum Payment Disruption accelerated payments to providers experiencing potentially significant cash-flow problems as a result of the cyberattack on UnitedHealth Group’s subsidiary Change Healthcare/Optum .
Andrew E. Blustein and Kathleen M. Brown will present "Compliance and Governance: Maintaining Operational Excellence for FQHCs" at the 2024 New Jersey Primary Care Association (“NJPCA”) Annual Conference, on October 10th.
On October 12, 2024, the New York State Department of Health (“DOH”) published the final cybersecurity regulations for general hospitals (the “Regulations”), with some provisions effective immediately.
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.
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.
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.
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.
Congress has once again extended certain telehealth flexibilities until September 30, 2025 (which coincides with the end of the Congressional fiscal year).
Garfunkel Wild's Stacey L. Gulick, Kathleen M. Brown, and Alison T. Schimel will present the webinar "Starting the Patient Journey: Essential Documentation for Treatment and Payment" on April 16, 2025, from 12:00 PM - 1:00 PM ET.
On July 23, 2025, the United States Department of Health and Human Services, Office of Civil Rights (“OCR”) announced a $250,000 settlement with the Specialty Surgery Center of Central New York (the “Surgery Center”) as a result of a ransomware attack involving the PYSA ransomware variant, which is known to target the healthcare industry.
On August 1, 2025, the Health Resources and Services Administration issued a new pilot initiative under the 340B Drug Pricing Program that may significantly reshape longstanding pricing and discount frameworks. The 340B Rebate Model Pilot Program will allow participating drug manufacturers to offer post-sale, rebates to eligible 340B Covered Entities for select drugs, rather than providing upfront discounts.
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.
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.
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.
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.
Congress has once again temporarily extended key Medicare telehealth flexibilities, this time through January 30, 2026.
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.
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.
On August 1, 2025, the Health Resources and Services Administration issued a new pilot initiative under the 340B Drug Pricing Program that may significantly reshape longstanding pricing and discount frameworks. The 340B Rebate Model Pilot Program will allow participating drug manufacturers to offer post-sale, rebates to eligible 340B Covered Entities for select drugs, rather than providing upfront discounts.
On July 23, 2025, the United States Department of Health and Human Services, Office of Civil Rights (“OCR”) announced a $250,000 settlement with the Specialty Surgery Center of Central New York (the “Surgery Center”) as a result of a ransomware attack involving the PYSA ransomware variant, which is known to target the healthcare industry.
Garfunkel Wild's Stacey L. Gulick, Kathleen M. Brown, and Alison T. Schimel will present the webinar "Starting the Patient Journey: Essential Documentation for Treatment and Payment" on April 16, 2025, from 12:00 PM - 1:00 PM ET.
Congress has once again extended certain telehealth flexibilities until September 30, 2025 (which coincides with the end of the Congressional fiscal year).
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.
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.
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.
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.
On October 12, 2024, the New York State Department of Health (“DOH”) published the final cybersecurity regulations for general hospitals (the “Regulations”), with some provisions effective immediately.
Andrew E. Blustein and Kathleen M. Brown will present "Compliance and Governance: Maintaining Operational Excellence for FQHCs" at the 2024 New Jersey Primary Care Association (“NJPCA”) Annual Conference, on October 10th.
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.
The HIPAA Privacy Rule to Support Reproductive Health Care Privacy was recently announced as a final rule that becomes effective on June 25, 2024 (the “Final Rule”).
On March 9, 2024, CMS announced it will make available Change Healthcare/Optum Payment Disruption accelerated payments to providers experiencing potentially significant cash-flow problems as a result of the cyberattack on UnitedHealth Group’s subsidiary Change Healthcare/Optum .
Additional speaking & writing
Publications
- Authored chapters entitled “Immunizations” and “Issues Involving Infectious Diseases” in the Legal Manual for New York Physicians (Sixth Edition)
Practices
Education
- cum laude
- Kate Stoneman Award, 2014
- Student Service Award, 2013
- cum laude, Criminal Justice
Court admissions
U.S. District Court: Northern District of New York
PROFESSIONAL MEMBERSHIPS
Women’s Bar Association of the State of New York (WBASNY); 2011 to present
Capital District Women’s Bar Association (CDWBA); 2011 to present
New York State Bar Association (NYSBA); 2011 to present
American Health Law Association
Committee on Character & Fitness, NYS Supreme Court, Appellate Division, 3rd Judicial Department
AWARDS & RANKINGS
Best Lawyers in America® Ones to Watch – Health Care Law (2024-2025)
Super Lawyers – Upstate New York Rising Star (2020-2025)
