Anne Brendel is an associate based in San Francisco and a member of Goodwin’s Life Sciences group and Healthcare practice.
Anne focuses her practice on regulatory and transactional-support matters affecting a variety of health care industry clients, including telehealth companies, physician groups, pharmacies, ambulatory surgery centers, outpatient clinics, behavioral health providers, residential treatment centers, sober living facilities, and hospitals.
Anne’s regulatory practice is concentrated on healthcare fraud and abuse, corporate practice, privacy, consent, Medicare and Medicaid enrollment, reimbursement and billing, licensing and certification, accreditation, and compliance. Anne assists clients with meeting reporting and payment requirements under the Medicare 60-Day Rule and 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, lab diagnostic tests, and medications and negotiating settlements, including Corporate Integrity Agreements.
She also has healthcare service plan licensing experience and advises healthcare service plans with regard to compliance with California’s Knox-Keene Act.
- 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
- 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
- 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.
The George Washington University
BSBusiness Administration, International Business2008
University of Nevada, Reno
- 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