Danielle E. Sapega

Member

Danielle is a health law attorney focused on transactions and regulatory compliance. She helps clients navigate the complexities of health care industry mergers and acquisitions, divestitures, joint ventures and co-management agreements, venture capital and private equity investments, public offerings, and recapitalizations. Danielle advises clients on sophisticated deal transactions in nuanced health care sectors, assisting with due diligence, pre- and post-transaction compliance, licensing, regulatory filings, risk mitigation, and operational transition issues. She also regularly counsels clients on technical federal and state health law matters, including fraud and abuse, privacy and data breach incidents, Medicare and Medicaid reimbursement-related issues and audits, corporate practice of medicine and fee-splitting prohibitions, and general corporate compliance. Danielle is considered go-to counsel for compliance, training, and advice on HIPAA.

Before joining Cozen O’Connor, Danielle was associate counsel at Penn Medicine Lancaster General Health (LGH) where she negotiated hospital contracts and counseled hospital leadership on HIPAA/HITECH, Stark and Anti-Kickback laws, governance, policy management, medical credentialing, governmental survey preparation and accreditation, regulatory filings, and information security. She assisted with the development and establishment of several clinical and non-clinical joint venture projects with partner providers, employers, and community-based assistance programs. She drafted board governance documents and presented to LGH boards on relevant legal issues. She also provided counsel to inpatient and outpatient clinical personnel on day-to-day patient risk and legal matters.

Danielle has many years of experience serving as a member of multiple Institutional Review Boards. In this role, she provided legal perspective on informed consent documents and clinical protocols, assisting with regulatory compliance, ethical standards, and risk mitigation. During her time at LGH, Danielle negotiated clinical trial sponsorship agreements on behalf of LGH’s affiliated research institute and assisted with maintaining the institute’s AAHRPP accreditation.

Danielle earned her bachelor’s degree in political science from the University of Michigan and her law degree from Temple University Beasley School of Law, where she served as executive editor of the Temple Journal of Science, Technology, and Environmental Law. Danielle also holds a master’s degree in health policy from Thomas Jefferson University College of Population Health.

News

Cozen O’Connor Represents Albaron Partners in First Private Equity Exit in U.S. Podiatry

January 09, 2024

PHILADELPHIA, January 9, 2024 — Cozen O’Connor advised Albaron Partners, a middle-market private equity firm focused on founder-led health care companies, in its sale of Albaron Podiatry Holdings LLC d/b/a Beyond Podiatry, a leader in the management of podiatric medicine in the Midwest, to CUC Inc. The deal represents the first private equity exit in U.S. podiatry history.

Cozen O’Connor Promotes 15 Attorneys to Member

March 25, 2021

Cozen O'Connor promoted 15 attorneys to member: Donnie Apodaca, Brian Burack, Jason Cabrera, Kristina Cherevas, Jonathan Gale, Matthew Glavin, Yehudah Gordon, Max Kaplan, Jason Kreps, Anna Will Kentz, Daniel Levine, Peter Lim, Matthew Policastro Laura Reinhart, and Danielle Sapega.

Pro Bono Lawyers at Weber Gallagher, Cozen O'Connor and Other Firms Have Gotten Creative in COVID-19 Response

May 06, 2020

Greg Fliszar and Danielle Sapega were quoted in The Legal Intelligencer about their pro bono work with the Physician Support Line during the COVID-19 pandemic.

Publications

HIPAA “Right of Access” Enforcement Trend Continues [Health Law Informer Blog]

September 27, 2022

The Office of Civil Rights of the Department of Health and Human Services (“OCR”) announced the resolution of three more right of access cases, bringing the total to a whopping 41 since the start of its drive to increase compliance with this Health Insurance Portability and Accountability Act...

Office of Civil Rights Releases Patient Privacy Guidance in the Wake of Dobbs Decision [Health Law Informer Blog]

July 01, 2022

Patient privacy concerns are at an all-time high following the Supreme Court’s ruling in Dobbs v. Jackson Women’s Health Organization. Following their statements affirming that abortion constitutes basic and essential health to which every woman should be entitled issued by both Xavier Becerra,...

Compliance with the hospital price transparency law almost a year in: Where are we now? [Cosmos]

December 01, 2021

Christopher Raphaely and Danielle Sapega co-authored an article about the Centers for Medicare & Medicaid Services (CMS) hospital price transparency rule, which has been in effect since January 1, 2021.

HHS, Treasury and Labor Release First Set of Surprise Billing Rules [Health Law Informer Blog]

July 02, 2021

The United States Departments of Health and Human Services, Treasury and Labor released interim final rules (“Rules”) regarding the “No Surprises Act” (“Act”) yesterday. The Rules are effective beginning on January 1, 2022. They cover the requirements for the billing and payment of emergency and...

Northern District of California Grants Preliminary Injunction Against Most Favored Nation Rule [Health Law Informer Blog]

December 29, 2020

On December 28, 2020, the District Court for the Northern District of California granted a motion for a preliminary injunction enjoining the Centers for Medicare and Medicaid Services from implementing the Most Favored Nation Rule (the “Rule”, summarized in our December 23 post) until the notice...

District Court grants TRO on Most Favored Nation Rule [Health Law Informer Blog]

December 23, 2020

On December 23, 2020, The District Court for the District of Maryland granted a temporary restraining order temporarily ceasing the implementation of the Centers for Medicare and Medicaid Services’ (“CMS”) Most Favored Nations Rule (the “Rule”) for fourteen (14) days. The Rule, published on...

CMS Releases Final Stark Rules To Promote Value-Based Care [Health Law Informer Blog]

November 23, 2020

On Friday, November 20, 2020, the Centers for Medicare and Medicaid Services (“CMS”) released final regulations to remove certain barriers to the implementation of physician compensation arrangements under value-based payment arrangements posed by the “Stark” Physician Self-Referral law. The...

Pennsylvania Act 80: Central Service Technician and Surgical Technologist Regulation Act [Health Law Informer Blog]

November 06, 2020

On October 29, 2020, Governor Wolf signed House Bill 81 into law, creating new minimum education and certification requirements for central service technicians and surgical technicians working in the Commonwealth, and regulating the practice of surgical technology. The Act will take effect on...

A Week After Pharma Price Disclosure Is Rule Struck Down, D.C. Judge Upholds Hospital Price Transparency Rule [Health Law Informer Blog]

June 24, 2020

As we indicated in last week’s blog post , the D.C. Circuit Court’s refusal to uphold HHS’ pharmaceutical price disclosure rule (“RX Rule”) was not a predictor of how the trial court might rule in the closely watched challenge to HHS’ hospital price transparency rule (“Hospital Rule”). In a June...

Pharma Price Disclosure Rule Struck Down: Will Hospital Price Transparency Rule Meet the Same Fate? [Health Law Informer Blog]

June 19, 2020

On June 16, the D.C. Circuit Court struck down the Centers for Medicare and Medicaid Services’ (“CMS”) rule issued in May 2019 requiring pharmaceutical companies to disclose the wholesale acquisition cost of drugs over $35 in their direct-to-consumer television advertisements (“RX Rule”). Similar...

Pennsylvania Attorney General Announces Nursing Home Criminal Investigations [Alert]

May 15, 2020

Danielle Sapega discusses the Pennsylvania attorney general's investigation into nursing homes, the Department of Health's guidance for nursing homes, and the governor's executive order granting immunity to health care workers.

Additional Health Care Provider Relief Funds In April Stimulus Bill [Health Law Informer Blog]

April 28, 2020

On Friday, April 24th, President Trump signed the Paycheck Protection Program and Health Care Enhancement Act (“Act”) into law that will send an additional $75 billion to the Public Health Emergency and Social Services Fund (“Fund”) used to reimburse eligible health care providers for health care...

CMS Announces Enhanced Nursing Home Reporting Requirements

April 20, 2020

Danielle E. Sapega and Gregory M. Fliszar discuss CMS's new guidance for nursing homes when it comes to reporting confirmed or suspected cases of COVID-19.

OCR Releases Notification of Enforcement Discretion at COVID-19 Community-Based Testing Sites [Alert]

April 14, 2020

Danielle Sapega and Gregory M. Fliszar discuss OCR's announcement relaxing HIPAA rules in connection with the good faith participation in the operation of a COVID-19 Community-Based Testing Site(s)

HHS to Release Highly Anticipated Public Health and Social Services Emergency Fund Guidance Soon [Health Law Informer Blog]

April 03, 2020

The CARES Act (“Act”) appropriates $100 billion to create a Public Health Social Service Emergency Fund (“Fund”) to prevent, prepare for, and respond to coronavirus domestically and internationally for necessary expenses to reimburse, through grants or other mechanisms, eligible health...

Summary and Analysis of Key Provisions of the CARES Act

March 28, 2020

Members of Cozen O'Connor's Coronavirus Task Force provide analysis of the CARES Act and how it will impact small businesses, distressed industries, employers and employees, taxes, and the health care, real estates, and energy industries.

OCR Releases Guidance on the Disclosure of PHI to First Responders and Public Health Authorities [Alert]

March 26, 2020

Danielle E. Sapega and Gregory M. Fliszar discuss the latest guidance from OCR on when it is permissible to disclose the minimum necessary information of individuals infected with COVID-19.

HIPAA and COVID-19: Balancing Public Health Concerns and Patient Privacy in the Midst of a Pandemic [Alert]

March 13, 2020

Gregory M. Fliszar and Danielle Sapega discuss the HIPAA Privacy and Novel Coronavirus bulletin and what providers and covered entities need to know during a public health emergency.

5th Circuit Holds Individual Mandate is Unconstitutional, but Remands to District Court to Decide Severability [Health Law Informer Blog]

December 19, 2019

In a 2-1 decision published on December 18, 2019, a 5th Circuit panel upheld the Texas District Court’s decision ruling that the ACA individual mandate tax which, since January 2019, has had no monetary consequence, is unconstitutional. Citing the Supreme Court’s 2012 NFIB v. Sebelius opinion, the...

Pennsylvania Act 112 of 2019: Opioid Treatment Agreements [Health Law Informer Blog]

December 03, 2019

As another mark of progress in the fight against opioid addiction, Governor Wolf signed Senate Bill 572 (the “Act”) into law on November 27, 2019, requiring prescribing providers (referred to as “Prescribers”) to take several additional steps before issuing a prescription for an opioid in...

Events & Seminars

Upcoming Events

Health Care & Life Sciences 2025

December 05, 2024 - Philadelphia, PA

Cozen O'Connor will host Health Care & Life Sciences 2025, our annual in-person seminar exploring critical issues impacting health care and life sciences businesses.

Past Events

Health Law 2024

December 05, 2023 - Philadelphia, PA

Health Law 2022

December 08, 2021 - Webinar

Health Law 2021

December 07, 2020 - Webinar

Health Law 2020

December 04, 2019 - Philadelphia, PA

Education

  • Temple University—James E. Beasley School of Law, J.D., 2011
  • Thomas Jefferson University College of Population Health, M.S., 2018
  • University of Michigan, B.A., 2007
  • New Jersey
  • Pennsylvania