Anne M. Brendel

Anne Brendel is a senior associate based in Washington, DC, working remotely in Reno, NV, and is a member of the firm’s Healthcare, Technology, and Women’s Health and Wellness groups.

Anne focuses her practice on regulatory, privacy, and litigation and transactional-support matters affecting a variety of healthcare industry clients, including digital health companies (including early stage and high growth companies), laboratories, fertility clinics, medical groups, pharmacies, ambulatory surgery centers, outpatient clinics, behavioral health providers, residential treatment centers, sober living facilities, and hospitals.

Anne is a comprehensive, trusted advisor to both healthcare providers, healthcare support technology platforms, and their private equity and venture capitalist investors. She advises clients on complex matters related to licensing, certification, and accreditation; consent; HIPAA (including breach notifications); reimbursement and billing; fraud and abuse; restrictions on corporate practice and fee-splitting; and compliance with federal and state laws and third-party payor requirements. Anne regularly supports digital healthcare start-ups from concept to nationwide expansion.

Anne assists clients with responding to recoupment requests from third-party payors and meeting reporting and payment requirements under the Medicare 60-Day Rule, including filing self-disclosures under the OIG’s Self-Disclosure Protocol for potential violations involving civil monetary penalties and CMS’s Voluntary Self-Referral Disclosure Protocol for potential Stark Law violations. She has experience responding to federal government subpoenas and civil investigative demands involving alleged fraudulent billing for professional services, clinical laboratory tests, and medications – and negotiating settlements, including Corporate Integrity Agreements.

She also has healthcare service plan, including dental plan, licensing experience and advises health plans with regard to compliance with California’s Knox-Keene Act and analogous state laws.

Regulatory

• Provide day-to-day compliance counseling for management services organization (MSO); emergency medicine, anesthesia, intensivist and hospitalist groups; hospitals; nursing groups; and ambulatory surgery centers (ASCs)
• Assist newly formed telehealth companies with launches and nation-wide expansions, including setting up Friendly PC Models
• Prepare and assist with implementing Compliance Programs for various health care providers and billing companies
• Advise health care providers, including ASCs, remote patient monitoring (“RPM”) providers, telehealth, and durable medical equipment (DME) suppliers on billing and reimbursement related matters
• Advise on HIPAA-related matters, including responses to OCR requests and compliance and breach notification requirements
• Advise clients on billing and reimbursement related matters, including federal and state anti-kickback, fee-splitting, and fraud and abuse compliance
• Negotiate agreements with health plans in connection with pilot programs and participation in health plan networks

Investigations and Enforcement

• Represented and advised clinical diagnostic laboratories in connection with responding to a Civil Investigative Demand from the U.S. Department of Justice (“DOJ”) and demands from various state-level agencies related to CLIA certification and medical necessity
• Represented and advised oncology provider in connection with responding to Civil Investigative Demand from DOJ, including settlement agreement negotiation and compliance with a Corporate Integrity Agreement (“CIA”)
• Represented and advised gynecologist in connection with responding to Medicaid audit related to California’s Family PACT program
• Represented applied behavioral analysis (“ABA”) provider with responding to Special Unit Investigations letter from a major behavioral health care plan, including negotiating a settlement

Transactional

• Represented Medical Properties Trust, Inc. (“MPT”) in conjunction with an affiliated of Lifepoint Health, Inc.’s (“LifePoint”) acquisition of a majority ownership interest in Springstone Health Opco, LLC (“Springstone”), from Springstone’s management group. In conjunction with this transaction, MPT, also an owner of Springstone, sold its approximately $190 million loan, plus accrued interest, to Lifepoint for approximately $205 million in a cash transaction
• Advised Pear Therapeutics, the leader in developing and commercializing software-based medicines, called prescription digital therapeutics (PDTs), in its business combination with Thimble Point Acquisition Corp. (“THMA”), a special purpose acquisition company (SPAC), pursuant to which Pear went public via de-SPAC transaction
• Assisted Generate Biomedicines, the first drug generation company pioneering a machine learning-powered multimodality Generative Biology platform and Amgen, a leader in biotechnology-based human therapeutics, with in their research collaboration agreement to discover and create protein therapeutics for five clinical targets across several therapeutic areas and multiple modalities
• Represented MPT in its acquisition of Springstone Holdings, Inc. operator of 18 inpatient behavioral health hospital facilities in Arizona, Colorado, Indiana, Kansas, North Carolina, Ohio, Oklahoma, Texas, and Washington) from Welsh, Carson, Anderson & Stowe for an aggregate purchase price of $950 million
• Represented Found Health, Inc. in completing its initial closing of its $100 million Series B financing, raising approximately $99.3 million
• Advised the underwriters in Bright Health Group’s, a healthcare company aligning the local resources in healthcare delivery with the financing of care, driving a superior consumer experience, optimizing clinical outcomes, reducing systemic waste, and lowering costs, $924.3 million initial public offering
• Advised JMI Equity on its definitive agreement and complete health care regulatory diligence in connection with the acquisition of Timely Telehealth, student-focused telehealth platform company
• Regularly advise various buyers and sellers in connection with the health care regulatory aspects of transactions involving ABA clinics, substance abuse treatment centers, comprehensive rehabilitation outpatient facilities (“CORFs”), sleep centers, pharmacies, fertility clinics, medical groups, digital health companies, psychiatric hospitals, and ASCs
• Regularly assist with change of ownership requirements affecting Medicare, Medicaid, federal and state health care licenses, and third-party payor agreements triggered by transactions

Women's Health / Fertility

• Advised women’s mail order contraceptive companies and pharmacies with telehealth visit requirements, child prescribing limitations, nursing supervision, and Medicaid managed care compliance matters
• Assisted naturopathic hormone-assistance company with launch and regulatory compliance
• Represented private equity firm in its investment of a family benefits platform
• Assisted with launch of telehealth group focused on menopause management
• Assisted with launch of telehealth company providing hormone testing and primary care for women
• Regularly provide day-to-day compliance counseling to fertility clinics

Pro Bono

• Provide health care compliance counseling to non-profit health care providers, including pediatric practices and health technology companies
• Assist non-profits, including a disability advocacy group, with third-party payor agreement negotiations

Prior to joining Goodwin, Anne was most recently an associate at Buchalter in Los Angeles.

Anne is a member of the American Health Law Association, Leadership Development Program participant in the Payers, Plans, and Medical Care Practice Group, California Society for Healthcare Attorneys, and the Center for Connected Health Policy’s California Telehealth Policy Coalition.

Winner of Mondaq’s Autumn 2023 Thought Leadership Awards for Data Protection in the US.

• Co-Author, “A Changing Regulatory and Reimbursement Landscape for Weight-Loss Drugs,” Goodwin Client Alert, March 27, 2024
• Co-Author, “In Updated Guidance on Use of Tracking Technologies by HIPAA Regulated Entities, HHS-OCR Takes Expansive View of When Information Related to Unauthenticated Individuals Is PHI,” Goodwin Client Alert, March 27, 2024
• Co-Author, “Alabama IVF Clinics: Potential Implications of the LePage Case,” Goodwin Client Alert, February 23, 2024
• Co-Author, “HHS OCR Proposes Changes to HIPAA to Support Reproductive Health Care Privacy,” Goodwin Client Alert, August 10, 2023
• Co-Author, “Starting in April 2024, California Joins Growing Trend of Implementing Advance Review Processes for Healthcare Transactions,” Goodwin Client Alert, June 21, 2023
• Co-Author, “DEA Proposes Rules to Allow Prescribing Controlled Substances via Telemedicine, Subject to Significant Limitations,” Goodwin Client Alert, March 23, 2023
• Co-Author, “Implications of Abortion Laws for Fertility Services,” Goodwin Insight, January 20, 2023
• Co-Author, “Five Key Regulatory Considerations for Virtual Ketamine Clinics,” Goodwin Client Alert, November 16, 2022
• Co-Author, “The Potential Impact of State Abortion Laws on Reproductive Health Apps,” Goodwin Client Alert, July 19, 2022
• Co-Author, “Taking Security Interests in Human Reproductive Tissue: Clarifying Lender Options under Federal and State Law,” Goodwin Client Alert, July 14, 2022
• Co-Author, “President Biden Signs Into Law Medicare Telehealth Coverage Extension Post-Public Health Emergency,” Goodwin Blog: Life Sciences Perspectives, March 16, 2022
• Speaker, “Key Regulatory Issues for Digital Health Companies,” Lawline, December 2023
• Speaker, “Telemedicine Management Services Agreements,” LawPracticeCLE, October 19, 2022
• Quoted, “The No Surprises Act is in effect. Here’s what you need to know.,” Phreesia, January 26, 2022
• Contributor, “Practical Considerations for Analyzing Telemedicine and Telehealth Legal Issues,” AHLA Toolkit, May 2021
• Speaker, “Telehealth Legal Components — Licensure. State Waivers, etc.,” Healthcare Training Leader, May 5, 2021
• Co-Author, “Enforcement 2020: Telehealth Providers Move to the Top of OIG’s Watch List,” AHLA PG Bulletin, December 16, 2020
• Quoted, “Ethics of Warrantless Blood Draws in Hospital Setting,” Medical Ethics Advisor, January 1, 2020
• Panelist, 2018 Los Angeles State of Reform Health Policy Conference, September 19, 2019
• Author, “Navigating the comanagement waters: It can be treacherous, so don’t go it alone.,” Ophthalmology Management, March 1, 2018
• Co-Author, “Law Enforcement and Healthcare: When Consent, Privacy, and Safety Collide,” The Journal of Urgent Care Medicine, February 1, 2018
• Quoted, “The Lost Art of Talking to the Patient,” The Review of Ophthalmology, December 15, 2017
• Author, “Section 1115 Waivers, The Future of Medicaid Expansion,” The Health Lawyer, February 1, 2015