Health Care

As regular readers of our blog know, the Centers for Medicare & Medicaid Services (CMS) intensified its push for drug pricing transparency in 2019. In 2020, we see a continuation of those efforts, and their impacts on the 340B program are now starting to reveal themselves. On January 1, 2019, the Health Resources & Services Administration (HRSA) finally implemented the ceiling price and manufacturer civil monetary penalties (CMPs) regulations that the agency proposed in 2017. The regulations implement certain provisions of the Affordable Care Act and were initially scheduled to go into effect on February 28, 2017, but were repeatedly delayed.

Theresa Carnegie reviews both the OIG’s and the CMS’s proposed rules as they relate to the new value-based arrangements safe harbors and Stark Law exceptions.

Rachel Yount discusses the proposed new safe harbor that would protect patient engagement and support arrangements designed to improve quality, efficiency of care, and health outcomes.

It feels like we’ve been seeing a lot more health care breaches caused by hackers and other IT security incidents recently, and there’s a good reason why: a recent report by cloud security company Bitglass confirms that both the number of breaches and individuals affected by breaches caused by hackers and IT incidents grew significantly last year.  Bitglass analyzed data from the breach portal, affectionately known as the “Wall of Shame,” published by the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR).  Pursuant to the HITECH Act, HHS is required to post a list of all reported breaches that affect 500 or more individuals. OCR classifies the types of breaches reported on the Wall of Shame, and the "Hacking/IT Incident" category includes a variety of breaches, including malicious intrusion, malware, ransomware, phishing, and general IT security failures.

On Tuesday, February 11, 2020, Senators Bill Cassidy (R-LA), Jeanne Shaheen (D-NH), and Tammy Baldwin (D-WI) introduced legislation to eliminate the “orphan drug loophole.” Current law allows the Food and Drug Administration (FDA) to grant seven years of market exclusivity to a drug manufacturer if the drug is intended to treat a disease or condition affecting fewer than 200,000 patients in the U.S., or less commonly, if the manufacturer cannot expect to recover the costs of developing and marketing a drug. In some cases, even if the drug developer meets the orphan drug criterion of having no hope of recovering the costs, the drug does actually become profitable—some significantly so—but competitors are still barred from entering the market with a lower-cost alternative during the 7-year exclusivity period that exists by operation of law. To combat this issue, the recently introduced Senate bill (as well as a nearly-identical House bill introduced in October 2019) targets a loophole that allows market exclusivity under the Orphan Drug Act to be extended for future versions of the same drug without the drug's manufacturer having to show that the drug remains unprofitable.

In this video, Aaron Josephson discusses FDA user fee agreements, the timeline for the reauthorization process, and why it is important for companies with FDA-regulated products to be paying attention now.

In CMS’s recently released proposed rule (the Medicare and Medicaid Programs: Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program and Programs of All-Inclusive Care for the Elderly) (the “Proposed Rule”) and supplemental HPMS memos, CMS is proposing several significant changes to its star rating system and to its methodology for reviewing plan past performance. This blog post highlights the key details of the proposed changes to the star rating system and past performance methodology and their potential impact on Medicare Advantage and Part D plans.

As the coronavirus remains to be an active outbreak with cases increasing within the United States, this is a good time to review how HIPAA applies in a public health emergency, including its restrictions and flexibility in these types of situations. Accordingly, last week, the Office for Civil Rights (OCR) released a helpful bulletin on how the HIPAA Privacy Rule comes into play with the coronavirus outbreak and other public health emergencies.

Karen Lovitch, Chair of Mintz's Health Law Practice, and Theresa Carnegie, a Member in the Health Law Practice, discuss the proposed changes to the Anti-Kickback Statute (AKS) and Stark Law issued by Department of Health & Human Services (HHS) and dive into some of the key issues.

Karen Lovitch, Chair of Mintz’s Health Law Practice, discusses the proposed new safe harbor and Stark Law exception for donations of cybersecurity technology and related services as well as the significant proposed modifications to the existing safe harbor and exception for electronic health records (EHR) technology and services.

Like many states, Massachusetts is considering drug pricing transparency legislation. The legislation would require pharmaceutical manufacturers to disclose certain pricing information.  Governor Charlie Baker has proposed legislation which would expand upon current reporting requirements for drug manufacturers in Massachusetts, and the Massachusetts Senate passed legislation which includes drug price transparency requirements and increased regulatory oversight of the pharmaceutical industry in Massachusetts. 

Joanne Hawana talks about the rise in direct-to-consumer genetic testing and how FDA has adapted its regulatory approach to such tests over the past few years as it has become more comfortable with genetic testing and sequencing technologies.

Joanne Hawana explains how FDA regulatory due diligence fits into the broader diligence that is done when a transaction involves an FDA-regulated entity as well as what the team is looking for when conducting an FDA regulatory diligence project.

This week, the U.S. Department for Health and Human Services (HHS) Centers for Medicare and Medicaid Services (CMS) released a proposed rule (the Medicare and Medicaid Programs: Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program and Programs of All-Inclusive Care for the Elderly), the 2021 Medicare Advantage and Part D Advance Notice of Methodological Changes for Medicare Advantage Capitation Rates and Part C and Part D Payment Policies (Part II), and multiple Health Plan Management System (HPMS) memos and notices covering topics including Medicare Advantage (MA) benefits, Medicare Part D bidding, and suspension of its Past Performance Review Methodology.  

Artificial Intelligence is a growing part of our day-to-day life. And AI promises to improve our health care system. ML Strategies Vice President Christian Tomatsu Fjeld recently sat down with other experts for a panel discussion hosted by the San Francisco Business Times to discuss AI and some business and policy considerations across multiple industries. This viewpoint considers some of the impacts on health care specifically, and links out to the panel's discussion.

Continuing progress on the initiatives announced in its Biosimilars Action Plan in July 2018 (see our prior post here), the Food and Drug Administration (FDA) released information about several important biosimilar-related actions on February 3, 2020. These recent moves make clear that FDA Commissioner Stephen Hahn, who was confirmed and sworn in to his new role at the tail end of 2019, is continuing to focus agency resources on the Biosimilars and Drug Competition Action Plans developed under the leadership of his predecessor, Dr. Scott Gottlieb.

As discussed in an earlier blog post, the process for reauthorizing human medical product user fee programs at the Food and Drug Administration (FDA) for another 5-year period is getting started this year. Below we highlight some changes made to the programs when they were last reauthorized through the 2017 Food and Drug Administration Reauthorization Act (FDARA) (P.L. 115-52) and consider what could be included in the upcoming user fee reauthorization package.

The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued a favorable Advisory Opinion regarding a proposal by a pharmaceutical manufacturer (Requestor) to provide financial assistance for travel, lodging, and other expenses to certain patients receiving a cell therapy that it offers (the Arrangement). The OIG concluded that the Arrangement could potentially violate the Anti-Kickback Statute as well as the prohibition on beneficiary inducement in the Civil Monetary Penalties Law (the Beneficiary Inducement CMP) but ultimately declined to impose administrative sanctions.

In November 2019, the Department of Health, along with the Department of Treasury and Department of Labor (“Departments”) released a proposed rule requiring group health plans and health insurance issuers in the individual and group markets to disclose cost-sharing information to enrollees (“Proposed Rule”). Earlier this month, the Departments extended the deadline for comments on Proposed Rule to January 29, 2020. To date and with one day remaining in the comment period, the Departments have already received over 20,000 comments on the Proposed Rule.

A history of FDA human medical product user fee programs, including those for prescription drugs (PDUFA), generic drugs (GDUFA), biosimilars (BsUFA), and medical devices (MDUFA), their negotiation and reauthorization, and how manufacturers and patients can participate and get involved in the negotiations.