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OCR Releases Long Awaited Final Rule Regarding the Conscience Protections for Religious and Moral Objections in Health Care

January 29, 2024 | Blog | By Madison Castle, Kathryn Edgerton, Maya Lytje, Matthew Tikhonovsky, Rachel Wang

On January 11, 2024, the Office of Civil Rights (OCR) issued its highly anticipated Final Rule regarding conscience protections. The Final Rule clarifies the religious beliefs and moral convictions protections practitioners and entities may assert in their health care practices. The Final Rule, entitled Safeguarding the Rights of Conscience as Protected by Federal Statutes, becomes effective March 11, 2024.
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Health Care Privacy and Security in 2024: Six Critical Topics to Watch

January 25, 2024| Blog|

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Federal Judge Rejects Pharma Manufacturers’ Challenge to Negative OIG Advisory Opinion

January 22, 2024 | Blog | By Rachel Yount, Abdie Santiago

A Virginia Federal Judge recently rejected a challenge to a negative Advisory Opinion issued by the Department of Health & Human Services’ Office of Inspector General (OIG) that disapproved of a proposal where certain pharmaceutical manufacturers would fund financial assistance for the manufacturers’ Part D oncology drugs. The Advisory Opinion was requested by the Pharmaceutical Coalition for Patient Access (PCPA), which is a charitable organization formed and fully funded by pharmaceutical manufacturers of oncology drugs. Subsequently, PCPA brought the lawsuit alleging that the negative Advisory Opinion violated the Administrative Procedure Act (APA).
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HHS, ONC HTI-1 Final Rule Introduces New Transparency Requirements for Artificial Intelligence in Certified Health IT

January 8, 2024 | Blog | By Pat Ouellette

The Department of Health and Human Services (HHS) was tasked with formalizing and coordinating efforts to regulate artificial intelligence (AI) in health care under the November 2023 Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (AI EO) and has already begun its regulation of AI within certain certified health IT. HHS and Office of the National Coordinator for Health Information Technology (ONC) recently published the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule.
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OIG Issues a Favorable Advisory Opinion on Vendor’s Offer of Gift Cards to Physician Practices for Recommending the Vendor’s Services

January 5, 2024 | Blog | By Rachel Yount

The Office of Inspector General (OIG) started 2024 with a flurry of activity by issuing four new Advisory Opinions on January 3, 2024. In one of these Advisory Opinions, the OIG approved a vendor’s referral program that offered gift cards to physician practices that are existing customers in exchange for recommending the vendor’s services to prospective physician customers. In doing so, the OIG adopts a position that directly contradicts the position that the Department of Justice (DOJ) espoused in multiple False Claims Act (FCA) settlements involving similar referral programs offered by electronic health record (EHR) vendors in which the DOJ alleged these programs violated the federal Anti-Kickback Statute (AKS).
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White House Launches Initiative on Women’s Health Research

January 3, 2024 | Blog | By Joanne Hawana, Maya Lytje, Rachel Wang

An important new initiative focused on women’s health research – defined as “the study of health across a woman’s lifespan in order to preserve wellness and to prevent, diagnose, and treat disease” – was recently kicked off in the United States. On November 13, 2023 the White House announced the Initiative on Women’s Health Research, to be led by First Lady Jill Biden and the Gender Policy Council. The Initiative aims to recognize and address the historic and persisting gaps in women’s health research and, by extension, in our collective knowledge about women’s health as well as how women experience certain conditions or respond to certain treatments differently than men.
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Looking Back and Moving Forward: MoCRA Regulatory Developments Ring in the New Year

January 2, 2024| Blog|

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Approved: California Regulations for the Pre-Closing Review of Health Care Transactions Finalized

December 28, 2023 | Blog | By Kathryn Edgerton, Deborah Daccord, Lara Compton

California’s new Office of Health Care Affordability (OHCA) is set to start pre-closing regulatory review of certain health care transactions on 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) soon will be subject to potential pre-closing transaction review.
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2023: Another Year Chock Full of Challenges for FDA

December 20, 2023 | Blog | By Joanne Hawana, Benjamin Zegarelli

In 2023, the FDA navigated challenges while achieving significant public health milestones. Member Joanne Hawana and Of Counsel Benjamin Zegarelli highlight key takeaways from the year, addressing multifaceted issues such as CBD regulation, the overhaul of in vitro clinical tests, and the management of manufacturing failures. These pivotal topics underscore the FDA’s proactive approach to evolving healthcare regulations and technological advancements.
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HHS Proposes Plan to Advance Cyber Resiliency in Health Care; OCR Settles Phishing Attack Investigation

December 12, 2023 | Blog | By Pat Ouellette

The U.S. Department of Health and Human Services (HHS) released a concept paper on December 6, 2023 outlining its action plan to enhance cyber resiliency in the health care sector by proposing certain voluntary cybersecurity actions and standards that may ultimately become requirements. For health care organizations such as hospitals, “cyber resiliency” generally means how organizations anticipate, operate during, respond to, and recover from cyber attacks such as ransomware attacks, cloud exploitations, phishing or spear-phishing attacks, software and zero-day vulnerabilities, or distributed denial of service attacks.
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Mintz Launches Podcast Series on Women Leaders in Health Care

December 8, 2023 | Blog

Mintz recently launched a new series of Health Law Diagnosed titled Women Leaders in Health Care. This new series highlights women leaders in the health care industry and includes discussions on key issues in the health care industry, women leaders’ reflections on their career, and the impact of mentorship. In our inaugural episode, Leah Pollema, Vice President and General Counsel at InhibRx, and Serene Katranji, Chief Operating Officer, Chief Compliance Officer, and Corporate Counsel at Orchard Laboratories, join host Bridgette Keller to share personal stories about their experiences as both mentees and mentors, shedding light on the invaluable impact mentorship has had on their professional journeys.
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Challenge to False Claims Act Qui Tam Provisions Fails in an Initial Attempt to Revive Long-Dormant Arguments as to Constitutionality Under Article II

December 7, 2023 | Blog | By Kevin McGinty, Keshav Ahuja

This July, we detailed the Supreme Court’s surprising revival in United States ex rel. Polansky v. Exec. Health Resources, No. 21-1052 (S. Ct. June. 16, 2023), of the question of whether the qui tam provisions of the False Claims Act (“FCA”), see 31 U.S.C. § 3730(b)(1), violate the Executive Branch’s exclusive grant of authority under Article II of the United States Constitution. In Polansky, a lengthy dissent by Justice Thomas questioned whether the False Claims Act qui tam provisions violated the Appointments Clause and Take Care Clause of Article II of the United States Constitution, arguments that had been endorsed by the Department of Justice (“DOJ”) in the 1989, though ultimately repudiated by DOJ just seven years later. A concurrence by Justice Kavanagh, joined by Justice Barrett, stated that “the Court should consider the competing arguments on the Article II issue in an appropriate case.” Shortly after Polansky was decided, a defendant in a declined qui tam case pending in the United States District Court for the Northern District of Alabama accepted Justice Kavanagh’s invitation, and moved to dismiss on Article II grounds. In a decision entered in November, the District Court rejected that challenge.
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HHS Court Filings Indicate that Agency Intends to Preserve Copay Accumulators

December 4, 2023 | Blog | By Theresa Carnegie, Xavier Hardy, David Gilboa

As we wrote about in our prior blog post, on September 29, 2023, John D. Bates of the U.S. District Court for the District of Columbia struck down a federal rule that permitted health plans and pharmacy benefit managers (PBMs) to exclude drug manufacturer copayment (copay) assistance from a patient’s cost sharing limits. In two separate filings this week, HHS signaled that it intends to support the continued use of copay accumulator programs as the industry has been using them since 2021.
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California Further Revises Proposed Regulations for the Pre-Closing Review of Health Care Transactions and Notifies Stakeholders of Upcoming Submission to the Office of Administrative Law

November 30, 2023 | Blog | By Lara Compton, Pamela Polevoy, Kathryn Edgerton, Daniel Cody, Deborah Daccord

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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New York State Prepares to Regulate Hospital Cybersecurity Programs

November 28, 2023 | Blog | By Sophia Temis, Cody Keetch, Jean D. Mancheno

On November 13, 2023, Governor Kathy Hochul announced plans to regulate cybersecurity for New York general hospitals regulated under Article 28 of the Public Health Law. As proposed, the regulations will provide an additional level of security for hospitals, which have been increasingly targeted for cybersecurity scams and breaches. The proposed regulations would be additive to those requirements of the federal Health Insurance Portability and Accountability Act (HIPAA), which already includes a variety of requirements meant to safeguard Protected Health Information (PHI). Accompanying the proposed regulations, a $500 million dollar fund has been appropriated under Governor Hochul’s FY24 budget to assist hospitals in complying with the proposed cybersecurity regulations. The funds will be made available through a Health Care Technology Capital program, which will be established by the New York State Department of Health (DOH).
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The LDT Debate: Unpacking Public Responses to FDA’s Proposed Rule

November 20, 2023 | Blog | By Benjamin Zegarelli, David Gilboa

The U.S. Food and Drug Administration (FDA) recently released a proposed rule that would seek to regulate laboratory developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). This rule could reshape the landscape of LDTs and, as expected, has generated substantial attention and feedback from the public, with both supportive and negative comments flooding in. We previously provided a summary of the proposed rule and FDA’s lengthy justification for it here. In this blog post, we will examine some of the key arguments presented in the public comments submitted to Docket FDA-2023-N-2177, as well as public statements published by industry trade associations.
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State AGs Demand Action on Pulse Oximeter Inaccuracy as FDA's Efforts Lag

November 14, 2023 | Blog | By Benjamin Zegarelli

A new battle is emerging in the fight for health equity, and it’s centered on the humble pulse oximeter. On November 1, 2023, 25 state attorneys general sent a letter to the Food and Drug Administration (FDA) demanding that the agency take urgent action to address pulse oximeter inaccuracies that continue to create health care risks for people of color. The letter comes exactly one year after a public meeting held by the Anesthesiology and Respiratory Therapy Devices Panel of the FDA’s Medical Devices Advisory Committee titled “Pulse Oximeter Accuracy and Limitations,” and nearly 21 months after the agency issued a safety communication about pulse oximeter inaccuracies when used on people with dark skin pigmentation (see our previous blog post on pulse oximeter performance here).
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FDA Delays Enforcement of MoCRA Facility Registration and Cosmetic Product Listing Requirements

November 13, 2023 | Blog | By Madison Castle, Jean D. Mancheno

Since the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was signed into law, cosmetics companies have spent the past year preparing to comply with its provisions. This includes the facility registration and cosmetic product listing requirements that have were mandated by Congress in the new law. Under MoCRA, the statutory deadline for meeting these foundational requirements is set at December 29, 2023 (one year after MoCRA’s enactment). However, on November 8, 2023, the Food and Drug Administration (FDA) issued Guidance for Industry: Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing (Compliance Guidance) and announced that enforcement of facility registration and cosmetic product listing requirements will be delayed six months.
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Key Takeaways from the OIG’s New Comprehensive General Compliance Program Guidance

November 10, 2023 | Blog | By Rachel Yount, Jane Haviland

The Department of Health and Human Services’ Office of Inspector General (OIG) published a General Compliance Program Guidance (GCPG) on November 6, 2023, marking the first update to OIG’s compliance program guidance documents (CPGs) since 2008 and advancing OIG’s Modernization Initiative first announced in a September 2021 Request for Information.
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Connecticut Law Imposes New Requirements on Pharmaceutical Manufacturers, Defined to Include Device and Cosmetic Manufacturers, that Employ “Pharmaceutical Sales Representatives”

November 9, 2023 | Blog | By Joanne Hawana, Jean D. Mancheno

Public Act No. 23-171: An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs (Act) took effect in Connecticut on October 1, 2023. Under the Act, a pharmaceutical manufacturer (PM) that employs pharmaceutical sales representatives (PSRs) is required to register with the Connecticut Department of Consumer Protection (Department) as a so-called “pharmaceutical marketing firm” (PMF). As discussed in our previous blog post, there are few jurisdictions in the United States that require registration or licensure of PSRs, and up until now, these obligations were placed on PSRs at the individual level. However, this new Connecticut law deviates from the typical regulatory scheme. In this post, we will provide an overview of the affirmative obligations that the Act imposes on PMs, PMFs, and PSRs and compare them to the laws, regulations, and ordinances of other United States jurisdictions.
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