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California is taking steps through Assembly Bill 254 (the “Bill”), approved by the State’s Governor on September 27, 2023, to ensure that patient information collected through reproductive or sexual health applications enjoys protections under the Confidentiality of Medical Information Act (the “CMIA”).[1] In addition to applying to providers and plans, the CMIA applies to businesses that offer software or hardware to consumers, such as mobile applications, which maintain medical information for the purpose of enabling management of such medical information or to otherwise support diagnosis, treatment, or management of a medical condition.[2] As a result, software and application developers may need to consider the CMIA with respect to their obligations relating to this particular data. In addition to certain confidentiality requirements, the CMIA also prohibits certain marketing uses and disclosures and requires breach notification in certain qualifying instances.Continue Reading California Moves to Protect Medical Information Collected Through Reproductive and Sexual Health Applications

The Florida Legislature recently amended the Florida Electronic Health Records Exchange Act (the “Act”) to prohibit certain health care providers utilizing certified electronic health record technologies from storing qualified electronic health records[1] outside of the United States, its territories, or Canada.[2] Significantly, the prohibition also extends to qualified electronic health records that are stored through a third-party or subcontracted computing facility or cloud service provider.[3]Continue Reading Florida Bans Offshoring of Certain Patient Information

Executive Summary

The California Department of Managed Health Care (“DMHC”) issued a recent guidance interpreting the application of the No Surprises Act (“NSA”)—a new federal law prohibiting out-of-network healthcare providers from balance-billing patients for certain emergency and non-emergency services—in California.  Significantly, when determining which payment and dispute resolution processes will apply in a dispute regarding the value of non-contracted emergency and non-emergency services, the NSA expressly defers to existing state law which already protects patients from receiving “surprise” medical bills, as long as such state laws conform to certain requirements set forth in the NSA.  The NSA refers to such qualifying laws as “specified State law[s]”.  However, the NSA does not explicitly indicate which states’ existing balance billing laws qualify as “specified State law[s]”—rather, each state must independently review the provisions of the NSA to determine if its existing balance billing laws qualify.
Continue Reading DMHC Guidance Confirms that California Law, Not the Federal No Surprises Act, Governs Payment and Dispute Resolution Processes for Certain Out-of-Network Services Provided in California

On March 18, 2022, AdvaMed announced updates to the Code of Ethics on Interactions with Health Care Professionals (“Code”), a voluntary code that provides medical technology companies with guidance on ethically compliant interactions and relationships with healthcare professionals. The changes will take effect on June 30, 2022. The updates are part of a concerted effort by the medical device industry to respond to recent regulatory guidance and health industry trends. Below are 7 things that you need to know about these latest modifications.
Continue Reading 7 Things to Know About the New AdvaMed Code Updates

This post originally appeared as an article in the Los Angeles Daily Journal on October 29, 2021.

As of January 1, 2022, patients will no longer be at risk for one of the most detested practices in healthcare: surprise out-of-network bills.Continue Reading Relief from Surprise Bills – Congress Passes the No Surprises Act What Providers and Insurers Need to Know

If I printed a tee shirt for the 2020 J.P. Morgan Healthcare Conference, what would it say? In past years, it would have been “Big Data,” Analytics, Artificial Intelligence, ACA, Risk, Medicare Advantage or Quality. This year, I’d have to say it was: diversification, organic growth and scale. Almost every presentation we attended used those terms, to the point where I wanted to jump up and yell “Bingo! I got it already.” But the message that came through loud and clear this year is that the healthcare industry has figured out what it needs to do and where it needs to go – and that it is creating positive impact for patients while generating good profits by doing so.
Continue Reading Day 1 Notes at the 2020 J.P. Morgan Healthcare Conference

On March 4, 2019, the Centers for Medicare & Medicaid Services (“CMS”) published a wide-ranging proposed rule (“Proposed Rule”)[1] with the intent to “move the health care ecosystem in the direction of interoperability” in alignment with the objectives set out in the 21st Century Cures Act (“Cures Act”)[2] and Executive Order 13813.[3] According to CMS, this Proposed Rule is a key step in putting patients at the center of their health care and ensuring that they have access to their health information – attempting to solve the problem of accessing complete health information from different providers and payors. CMS believes patients should have the “ability to move from health plan to health plan, provider to provider, and have both their clinical and administrative information travel with them throughout their journey.”[4] A twin goal is that health IT should not “detract from the clinician-patient relationship… or from the quality of work life for physicians, nurses, and other health care professionals.”[5]
Continue Reading Overview of Proposed Rule from the Centers for Medicare & Medicaid Services Regarding Interoperability and Patient Access to Data

Laguna Niguel, California. Another wild year in healthcare is upon us and another insightful and inspiring week of discussions at the 2019 Health Evolution Summit (HES) has just wrapped up in California. HES, which many refer to as “Baby JP Morgan” (a reference to the annual JP Morgan Healthcare Conference in San Francisco, California), brings together some of the most influential minds and leaders in healthcare in an intimate setting offering the opportunity to participate in frank and detailed discussions regarding the healthcare industry, what we’re doing right, what we can do better, and what we envision for the future. Healthcare thought-leaders focused on disruptive technologies and Artificial Intelligence (“AI”), managed care, legislation and policy and virtually all other aspects of the healthcare system all participated in lively discussions throughout the week and we were privileged to join the fun.

Health, Not Healthcare. There was a true focus on consumerism, patient experience, and the delivery of “health, not healthcare” at the conference with an interesting dichotomy among companies focused on engagement of the portion of the population that does not take an active role in managing their own health (i.e., healthy people) and companies focused on those suffering from chronic conditions that require more hands-on involvement to manage a completely different set of challenges.
Continue Reading Notes from the 2019 Health Evolution Summit: Promoting Quality Healthcare and a Quality Healthcare Experience

The 2019 JP Morgan Healthcare Conference did not see multiple blockbuster announcements like in some earlier years but instead showcased an industry hard at work calmly and meaningfully trying to address and innovate to solve the industry’s structural, systemic and demographic challenges. We saw some companies trying to respond to the current fragmentation of healthcare delivery and financing through expansion of their vertical continuum, while others continued to strive to use technological solutions to shift behaviors and close gaps. There frankly was little question that the industry is continuing to move toward value-based and risk-based reimbursement – the challenge now is building or buying the necessary infrastructure, educating stakeholders and obtaining commitment and engagement, and structuring appropriate partnerships and relationships with other industry participants. We expect the pace of acquisitions and alliances to continue at current or higher levels as the industry repositions for this reimbursement shift. Similarly, the industry appears ready to innovate with artificial intelligence and machine learning, as incumbent technology providers develop new products and strategy and disruption is expected from new market entrants.

There also was no panic nor concerns voiced in the presentations we attended about the Affordable Care Act or the other possible results of the current political situation. Rather, several presenters noted that the exchange population relatively is minimal in size as compared to the commercial and Medicare/Medicaid markets. With exchange enrollment holding relatively steady and many plans reaching profitability with their exchange products, plans and providers are looking instead to the coming massive transformation of the commercial and federal products markets as risk further proliferates.
Continue Reading Day 3 Notes from the 2019 JP Morgan Healthcare Conference

What is Quality Anyways?: James Hinton, the CEO of Baylor Scott and White, got a good laugh from the audience when he said that he was proud to be one of the five or six hundred hospitals in the nation’s top 100 hospitals. And looking at the multiple “ego wall” slides we saw in day one and day two of the conference, all of which systems or companies were recognized for their outstanding quality and achievements, it brings to mind the old Lake Woebegon comment by Garrison Keillor that their town is a place where all of the children are above average. As some/many may ask, if everyone is doing so well per the awards, then how is it that we as a nation are not doing well with our health and our healthcare system? Is it just “those other guys” who are not winning those awards that are so far below average and dragging us all down in quality and exceeding in costs? Perhaps there is a place for some new thinking on measuring quality based on meeting patient goals, rather than third party quality organization goals. Put another way, healthcare today still is focusing more on process than results. Did you get your mammogram is the question, rather than did you make it another year without succumbing to a major disease.
Continue Reading Day 2 Notes from the 2019 JPMorgan Healthcare Conference

Please Don’t Poke the Baby – Sharing a best practice and talking about taking a local hospital learning and turning it into a systemwide approach, Mark Harrison of Intermountain Healthcare shared the fact that taking fewer blood samples from neonatal intensive care unit (NICU) babies was shown to lead to less infections in the NICU and on average a two week earlier discharge from the NICU. Who knew?

Drug Pricing – Drug pricing was on many lips today. Intermountain Healthcare launched Civica to address generic drug pricing and reported that it had approximately 500 hospital members now. More than one-third of US hospitals (!!) have inquired about joining Civica, which provides an exclamation point on the issue of generic drug pricing and availability. Mark Harrison of Intermountain said that products would start being available in 2019. He also noted that Civica doesn’t have to produce pills if the generic manufacturers will engage appropriately. Teva predicted generic drug market stabilization in their presentation today, which was also noted in the Walgreens Boots presentation as well. Walgreens Boots thought that the pace of cost reduction has slowed though. Let’s see who wins this game of “chicken.” Also today, Northwell announced that they were launching their own pharmacy benefit management (PBM) operation. We expect to see a lot of realignment and new entries in the PBM space, given the recent mergers and other activity (CVS/Aetna, Cigna/ESI, Anthem/IngenioRx). Much of the PBM space is being rethought now as its scope can expand to chronic condition management (an objective highlighted by Cigna today) or to medical benefits management as ESI is hoping with its recent acquisition of eviCore.
Continue Reading Day 1 Notes on the 2019 JP Morgan Healthcare Conference