Anne Brendel is an associate based in San Francisco and a member of Goodwin’s Life Sciences group and Healthcare practice.

Ms. Brendel 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.

Ms. Brendel’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. Ms. Brendel 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.

Experience

工作经历

EXPÉRIENCE

ERFAHRUNG

Ms. Brendel’s recent experience includes representation of:

Regulatory

  • Provide day-to-day compliance counseling for management services organization (MSO); emergency medicine, anesthesia, intensivist and hospitalist groups; hospitals; and nursing groups.
  • Provide day-to-date compliance counseling for ambulatory surgery centers (ASCs).
  • Regularly assist newly formed telehealth companies with launches and nation-wide expansions, including setting up Friendly PC Models.
  • Prepared and assisted with implementing Compliance Programs for various health care providers, including laboratories, medical groups, billing companies, management companies, and nursing groups.
  • Advised various provides, including ASCs, remote patient monitoring (“RPM”) providers, and dialysis providers, on billing and reimbursement related matters.
  • Regularly advise telehealth companies, health technology companies, health care providers, and other clients on HIPAA-related matters, including compliance and breach notification requirements.
  • Regularly advise clients on billing and reimbursement related matters, including federal and state 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

  • Represent and advise clinical diagnostic laboratory in connection with responding to a Civil Investigative Demand from the U.S. Department of Justice (“DOJ”) related to medical necessity and various state-level investigations and audits.
  • Represented and advise oncology provider in connection with responding to Civil Investigative Demand from DOJ, including settlement agreement and Corporate Integrity Agreement (“CIA”).
  • Represented and advise 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 mental health care payor, including negotiating a settlement.

Transactional

  • 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.
  • 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 sales of ABA clinics, behavioral centers, substance abuse treatment centers, comprehensive rehabilitation outpatient facilities (“CORFs”), sleep center, fertility clinics, medical groups, 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.
  • Represent private equity firm in its investment of a family benefits platform.
  • Assist with launch of telehealth group focused on menopause management.
  • Assist with launch of telehealth company providing hormone testing and primary care for women.
  • Regularly provide day-to-day compliance counseling to fertility clinics, including consent form, patient agreement, and compliance program reviews and updates.

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.
Professional Experience
Prior to joining Goodwin, Ms. Brendel was most recently an associate at Buchalter in Los Angeles. 
Professional Activities
Ms. Brendel 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.

In The News

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ACTUALITÉS

MELDUNGEN

Credentials

专业资格

RÉFÉRENCES

WERDEGANG

Education

J.D., 2014
The George Washington University
B.S., Business Administration, International Business, 2008
University of Nevada, Reno

Admissions

Bar

California
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