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Daniel A. Cody

Member

[email protected]

+1.415.432.6114

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Dan has more than 20 years of experience representing clients across the health care and life sciences sectors, including in the digital health industry, providing strategic counseling and leading civil fraud and abuse investigations.

Dan represents a diverse set of clients, such as hospitals, health systems, physicians, post-acute care entities, digital health and medical technology companies, life sciences organizations, and investors on a broad range of complex regulatory, compliance, privacy, and transactional matters. Dan assists clients in navigating evolving federal and state laws and regulations regarding pricing and reimbursement, licensing and accreditation, state corporate practice of medicine, privacy and consent, federal and state anti-kickback statutes, and federal and state self-referral provisions. He additionally oversees regulatory due diligence in mergers, acquisitions, and other transactional matters.

Drawing upon knowledge gained from representing a wide range of health industry sector clients and leveraging his extensive regulatory and compliance background, Dan represents clients in fraud and abuse matters in federal and state courts around the country, with an emphasis on matters involving the civil False Claims Act and similar state laws. Dan also conducts internal investigations and leads mediations and settlement negotiations.

Through the course of his practice, Dan regularly interacts with federal and state entities such as the Department of Justice, the Department of Health and Human Services, and state administrative and enforcement agencies.

In law school, Dan was a staff member of the William & Mary Law Review and an articles editor for the William & Mary Environmental Law and Policy Review.

Dan has more than 20 years of experience representing clients across the health care and life sciences sectors, including in the digital health industry, providing strategic counseling and leading civil fraud and abuse investigations.

Experience

Regulatory

  • Represent digital health companies, hospital systems, and home health and palliative care providers in maintaining compliance with multistate regulatory requirements applicable to telehealth activates of physicians and other health care professionals including licensing, establishing patient relationships, provider-to-provider consulting, supervision and delegation among providers, and prescribing and treatment standards.
  • Providing on-going strategic corporate, regulatory, and privacy advice and counsel to innovative membership-based clinics, hybrid, and telehealth only platforms providing primary, behavioral, and specialty health care.
  • Provide on-going counsel to health systems, physician groups, and other providers in connection with federal and state physician self-referral statutes including structuring arrangements, assessing compensation models, and making necessary self-disclosures.
  • Developed and implemented comprehensive compliance and data privacy programs for health care entities including digital health companies, hospitals, and post-acute care organizations.
  • Advised digital health companies and hospital systems in the establishment and operation of international telehealth programs.
  • Counseled an institutional pharmacy in its internal reorganization of its pharmacy services delivery system.

Investigations/Enforcement

  • Successfully represented a hospital system in resolving two novel federal and California qui tam False Claims Act matters involving the federal and California Department of Justice, Office of Inspector General of the Department of Health and Human Services, and California Department of Health Care Services alleging improper arrangements with Medicaid managed health care plans. 
  • Obtained favorable outcomes for digital health companies and their affiliated physician groups in responding to state medical board investigations regarding the provisions of clinical services including certain laboratory tests and prescription drug orders.
  • Represented a durable medical equipment company in connection with a federal and California qui tam False Claims Act lawsuit alleging violation of state best price requirements.
  • Successfully negotiated on behalf of a hospital system a favorable settlement of a national False Claims Act investigation involving implantable cardiac devices.
  • Obtained reversals of a Medicare contractor post-payment review overpayment determinations against physicians and post-acute care providers utilizing a creative administrate appeal/litigation strategy.
  • Represented an Arizona hospital in a False Claims Act investigation of Medicare claims submitted in connection with a clinical research trial.
  • Obtained successful dismissal of federal lawsuits filed against several hospitals and skilled nursing facilities alleging violation of the Medicare Secondary Payer provisions.

Transactional

  • Conducted health care regulatory due diligence on behalf of digital health companies, genetic testing laboratories, and post-acute care providers in connection with financing transactions.
  • Advised private equity companies in their acquisition of health care entities including strategic advice, regulatory due diligence, purchase agreement negotiations, and post-acquisition compliance activities.  
  • Advised a leading genetic testing laboratory in a sale to a newly formed international joint venture in a transaction exceeding $1.0 billion.

 

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viewpoints

The indictment, arrest, and arraignment of Ruthia He, the founder, CEO, and clinical president of Done Global (Done), and David Brody, clinical president of Done and the sole shareholder of Done Health, P.C. (PC) in connection with their alleged criminal conspiracy to distribute controlled substances, commit health care fraud, and obstruct justice may bring heightened scrutiny to behavioral health telemedicine companies and other virtual health platforms. The seven-count indictment represents the Department of Justice’s (DOJ’s) first criminal drug distribution prosecutions related to telemedicine prescribing. The prosecution of the defendants is proceeding in federal court in the Northern District of California and several additional Done personnel including an executive, physician, and nurse practitioners are similarly being prosecuted.

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States are increasingly exercising regulatory oversight of health care transactions by enacting laws requiring prior notice or approval of certain health care transactions. Currently, 15 states have enacted health care transaction review laws applicable to for-profit transactions. On Wednesday, March 20, 2024, Mintz members Daniel A. Cody, Deborah A. Daccord, and Karen S. Lovitch engaged in an insightful discussion with Lois Johnson, General Counsel of Massachusetts Health Policy Commission, to discuss the latest developments surrounding these laws and gain valuable insight from Ms. Johnson’s expertise, as Massachusetts was one of the first states to implement a health care transaction review process. The highlights of this informative conversation are summarized below, and the webinar can be viewed here.

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Despite the DOJ Criminal Division’s January 2023 revisions to its Corporate Enforcement Policy defining the criteria for declining to prosecute a criminal case, based on the two case examples from this past year, it is unclear how often the DOJ will actually put that policy into practice and decline or defer prosecution.

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In the past year, DOJ obtained some of its largest recoveries in cases where violations of the Stark Law, which bars physicians from profiting from self-referrals for certain services payable by Medicare or Medicaid, served as a predicate offense for FCA claims. These included cases against Community Health Network, Covenant Healthcare System, Cardiac Imaging, and Steward Health entities.

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Since May 2023, federal legislators have introduced more than 50 bills focused on issues related to AI technologies, with patient privacy, the role of clinicians, and health equity emerging as areas of focus. In addition, the Biden administration released an Executive Order focused on promoting AI safety in October 2023.

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In 2023, the Supreme Court and the US Courts of Appeals published a number of significant decisions involving FCA issues with implications for health care and life science entities, including a deepening circuit split on the causation standard applicable to FCA cases based on theories under the Anti-Kickback Statute.

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Several case dispositions from this past year, both criminal and civil, reaffirm DOJ’s policy of ensuring individual accountability in resolving allegations of wrongdoing and underscore the importance of considering that issue in the resolution of any FCA case.

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Health care companies using algorithms and AI applications face increased compliance risks. Previous technology-related enforcement suggests how relators and enforcement agencies might use AI to detect potential fraud and develop allegations based on how the technology is being used.

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California’s new Office of Health Care Affordability (OHCA) is set to begin advance regulatory review of certain health care transactions beginning January 1, 2024. As further explained in our previous post, subject to certain exceptions, a broad range of health care entities (collectively, Health Care Entities) will soon be subject to potential prospective transaction review. OHCA initially published proposed regulations for the new transaction review process in early August (for more details, see our prior post and podcast).  As further discussed in our previous post, these proposed regulations were revised in October and made available on the OHCA website, with a comment period that ended on October 17, 2023. In response to October’s public comments, OHCA has further revised the proposed regulations (Revised Regulations), which are available here. This time however, OHCA has also provided notice of proposed emergency regulatory action, indicating that this version of the regulations will be submitted to the California Office of Administrative Law (OAL) for approval. Once submitted, the public will have five days to provide comments to the OAL. If the OAL approves the regulations, it will file them with the California Secretary of State and the regulations will become effective as emergency regulations for five years as of the filing date. During this period, OHCA will proceed with regular rulemaking action addressing prospective health care transaction review.

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News & Press

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Mintz proudly announced the election of 13 attorneys to Members and the addition of a record-setting 22 new lateral Members in 2023, with 11 Partners in the newly opened Toronto office. This diverse group strengthens Mintz’s core areas, spanning Commercial and IP Litigation, Life Sciences, Tech, Private Equity, and Energy & Sustainability. The elevated Members and new lateral additions bring invaluable expertise to help clients navigate complex legal landscapes. 

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BOSTON –Mintz announced today that 39 of its practices and 81 of its attorneys earned recognition in the 2023 edition of Chambers USA, a guide to the country’s leading law firms.

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Law360 covered the arrival of Daniel Cody to the firm's San Francisco office.

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To support the growth of our San Francisco office in our core practices — including life sciences, private equity, and litigation — Mintz welcomed two new Members. Litigator Marc Axelbaum and health law attorney Daniel Cody will help serve hundreds of clients and kick-start plans to double our Bay Area headcount within two years.

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SAN FRANCISCO – Mintz is pleased to announce that Daniel Cody has joined the firm’s Health Law Practice as a Member in the San Francisco office.

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Dan has more than 20 years of experience representing clients across the health care and life sciences sectors, including in the digital health industry, providing strategic counseling and leading civil fraud and abuse investigations.

Recognition & Awards

  • Chambers USA: California ‬– Healthcare (2021‬ – 2024)

  • Daily Journal: "Top Health Care Lawyers" (2020)

  • The Legal 500 United States: Healthcare: Insurers (2017); Healthcare: Service Providers (2014, 2024)

  • Daily Journal: "Top 20 Attorneys Under the Age of 40" (2009) 

  • Nightingale's Healthcare News: "Outstanding Young Healthcare Lawyer" (2008)

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Dan has more than 20 years of experience representing clients across the health care and life sciences sectors, including in the digital health industry, providing strategic counseling and leading civil fraud and abuse investigations.

Involvement

  • Member, Health Law Section, American Bar Association
  • Member, American Health Lawyers Association
  • Member, California Society for Healthcare Attorneys
  • Honorary Board Member, Larkin Street Youth Services
  • Board Member, William & Mary Alumni Association Board
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