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On October 20, 2024, New York implemented a new law (NYS Public Health Law 18-c) that prohibits obtaining a patient's consent to pay before healthcare services are provided. Providers must now wait until after discussing treatment costs with the patient and after the services are rendered to obtain consent for payment.
For more information, read the article by Antony Kamel and Brandon Zarsky here.
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The Health Resources & Services Administration (HRSA) issued a letter to Johnson & Johnson (J&J) regarding its proposed 340B rebate model for STELARA and XARELTO purchases by Disproportionate Share Hospitals (DSH). HRSA stated the model violates the 340B statute, and J&J has until September 30, 2024, to notify HRSA that it has ceased implementation of the rebate proposal.
Arielle Miliambro and Maria Stahl delve further into HRSA’s remarks in a new article, read here.
UPDATE: On September 30th, J&J responded to HRSA’s statement on J&J’s proposed 340B rebate model and has formally rescinded its proposed rebate model. Although J&J contends that its rebate model does not violate the 340B statute and has reserved its rights in future legal disputes, J&J will not implement its 340B rebate model for purchases of STELARA and XARELTO by Disproportionate Share Hospitals.
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Independent healthcare providers face significant challenges, including clawbacks, competitive tactics, and administrative burdens. To combat these, small practices can join coalitions at various levels to drive change.
Daniel Frier and Theresa DiGuglielmo discuss strategies for identifying opportunities for alignment to support these efforts in a new article. Read here.
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The NJ Supreme Court recently issued a decision that clarified the limited scope of the privilege provided under the Patient Safety Act (PSA). The Court ruled that the confidentiality protections under the PSA apply only to documents and information generated exclusively by a facility's independent patient safety committee.
To learn more about the PSA and the court’s decision, read the article by Todd Brower and Christina Segreto here.
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A recent Settlement Agreement serves as a warning for healthcare providers involved in capitated payment models. Oak Street Health, a large provider with mostly Medicare and Medicaid patients, allegedly paid insurance agents and brokers to refer patients to its practice in order to increase its patient membership size, violating the AKS and FCA.
For a deeper dive into the case and key takeaways for capitated providers, read the article by Jason Silberberg and Diana Ryzhova here.
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On September 24, 2024, CMS announced that all certified Skilled Nursing Facility (SNF) and Nursing Facility (NF) providers will receive off-cycle provider enrollment revalidation notices beginning in October 2024. This follows a CMS Final Rule from November 2023, which mandates more extensive disclosure of ownership information.
To learn more, read the article by Christina Segreto and Todd Brower here.
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DMEPOS suppliers, is your surety bond up to date? Even an unintentional lapse could result in the revocation of your Medicare billing privileges and a re-enrollment bar of up to 10 years.
Learn more about the risks and how to protect your practice in our latest article by Nicole DeWitt and Theresa DiGuglielmo here.
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In a significant ruling, a Federal District Court in Colorado ordered HydraMed IV LLC, a mobile IV therapy company, to cease using Eli Lilly’s trademarks for MOUNJARO® and ZEPBOUND® in advertising and marketing. The court found HydraMed’s actions misleading, including claims suggesting their compounded drugs were genuine or generic versions of Eli Lilly's products.
Read the article by Arielle Miliambro and Maria Stahl here.
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In recent years, government agencies have increased scrutiny on the billing practices of mental health providers, particularly focusing on violations of the False Claims Act (FCA) through the "impossible day" scenario.
Jason Silberberg and Diana Ryzhova discuss this uptick in enforcement and what providers need to know in a new article here.
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Earlier this year, Eli Lilly and Pfizer launched direct-to-consumer (DTC) telehealth platforms, allowing patients to connect with remote prescribers and access medications. This week, several senators issued letters to these manufacturers expressing concerns around potential conflicts of interest and kickbacks in these programs.
Arielle Miliambro and Christopher Maniscalco shed light on the senators’ scrutiny surrounding these DTC programs and highlight considerations you need to know to remain compliant. Read here.
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Balancing Physician Rights and Hospital Actions in Harassment Cases
Join Frier Levitt partners Todd Brower, Alex Keoskey, and Christopher Mayer for an insightful webinar, “Balancing Physician Rights and Hospital Actions in Harassment Cases” on Wednesday, November 13, 2024, from 12:30 – 1:30 p.m. ET. The webinar will focus on the balance between physicians’ due process rights and hospitals’ obligations in harassment cases. These situations are complex and difficult to navigate. This webinar will equip viewers with the education tools and legal insights necessary to make informed decisions.
Click the image below to register:
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Who should attend?
This webinar is ideal for physicians and dentists with clinical privileges, in-house hospital counsel, corporate leaders at hospitals and healthcare systems, medical staff leaders, government regulatory counsel and investigators.
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340B & Telehealth: Regulatory Considerations
In this on-demand webinar, Frier Levitt attorneys Jesse Dresser, Arielle Miliambro, and Maria Stahl provide an in-depth overview of the 340B Drug Pricing Program and its intersection with innovative telehealth arrangements. This presentation highlights the complex regulatory landscape and underscores the importance for stakeholders to stay informed about legal developments and proposed changes.
Click the image below to view the webinar:
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Maria F. Stahl has earned the ANSI-accredited Certified Information Privacy Professional/United States (CIPP/US) credential through the International Association of Privacy Professionals (IAPP).
Maria is an attorney in Frier Levitt’s Healthcare Group and focuses her practice on regulatory and transactional law. She counsels pharmacies, diagnostic laboratories, healthcare practitioners, manufacturers, and healthcare technology and management companies on regulatory matters, including digital and telehealth data privacy.
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Frier Levitt’s Government Investigations, Litigation & White-Collar Defense Group is comprised of seasoned professionals, including a former Assistant United States Attorney, Deputy Attorneys General, and healthcare litigators who have decades of experience defending corporate entities, executives, and healthcare and life sciences professionals for alleged healthcare violations.
Our attorneys bring a wealth of firsthand knowledge of how government agencies conduct investigations and prosecute cases. This litigation-centric experience and skillset, combined with the firm’s extensive regulatory, transactional, and clinical knowledge, work to resolve such cases successfully, often doing so before public charges are filed.
Contact Frier Levitt to speak to an attorney about regulatory concerns, government inquiries, subpoena and CID defense, as well as litigation defense.
Learn more about Frier Levitt's Government Investigations, Litigation & White-Collar Defense here.
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© 2024 Frier Levitt. All rights reserved. ATTORNEY ADVERTISING.
The contents of this newsletter and all related communications do not constitute legal advice or an attorney-client relationship. Publication contents are for general information purposes and are not intended to be a substitute for legal advice. You should seek legal advice or other professional advice in relation to any particular questions that you or your organization may have.
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