As mentioned in our November 25, 2000 Healthcare Law Blog article, “Big Changes for Health Care Fraud and Abuse: HHS Gifts Providers Updates to the Stark Law and the AKS, Just in Time for the Holidays,” the Centers for Medicare & Medicaid Services (CMS) published a final rule (“Final Rule”) on December 2, 2020 making significant changes to the regulatory framework implementing the federal physician self-referral prohibition (the “Stark Law”), 42 C.F.R. 411.351 et seq.
Continue Reading Critical Analysis and Practical Implications of CMS’ Changes to the Stark Law’s Implementing Regulations

On November 20, 2020, the Centers for Medicare and Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) promulgated much-anticipated and significant final rules intended to “modernize” and “clarify” regulations regarding the Physician Self-Referral Law (“Stark Law Final Rule”) and the Anti-Kickback Statute (“AKS Final Rule”).  In the immediate future, Sheppard Mullin will post on this Healthcare Law Blog a comprehensive critical analysis of both the Stark Law Final Rule and the AKS Final Rule and their practical impacts.
Continue Reading Big Changes for Health Care Fraud and Abuse: HHS Gifts Providers Updates to the Stark Law and the AKS, Just in Time for the Holidays

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

On January 9, 2019, California Attorney General Xavier Becerra filed a motion with the U.S. Bankruptcy Court for the Central District of California – Los Angeles Division (the “Court”), requesting that the court stay its December 27th Sale Order, which approved Santa Clara County’s $235 million bid to purchase two hospitals from Verity Health System of California (“Verity”).[1] The Sale Order authorized Santa Clara County’s (the “County”) acquisition of O’Connor Hospital in San Jose and St. Louise Regional Hospital in Gilroy (including the DePaul Health Center in Morgan Hill) as part of Verity’s ongoing Chapter 11 Bankruptcy reorganization.[2]
Continue Reading California AG Aims to Block County’s Purchase of Two San Jose-Area Hospitals

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

San Francisco (January 11, 2018) – The final day of the 2018 JP Morgan Healthcare Conference gave us food for thought about the topic of healthcare navigation, as well as updates on the home health sector. Post-acute has become the focus of more attention, especially with the recently announced purchase by Humana of Kindred’s home health business. Genesis Healthcare’s presentation today also shared that they (the largest skilled nursing facility (SNF) operator in the U.S.) were at 84.6% occupancy and, given the growth in senior citizens, expected the SNF industry to run out of beds somewhere between 2020 and 2025. That’s a daunting forecast and clearly also emphasizes the importance of home health. But first, let’s look at the interesting topic of patient engagement and healthcare navigation.
Continue Reading Day 4 Notes on the 2018 JP Morgan Healthcare Conference

Retail clinics—the popular term for walk-in clinics located in pharmacies, supermarkets, and “big-box” stores—are playing an expanding role in the health care market. According to a study published by the New England Journal of Medicine, over 2,000 retail clinics were operating in the U.S. as of 2015.[1] Major players, such as CVS Health’s MinuteClinic, Walgreens’ Healthcare Clinics, and Kroger’s Little Clinic, are continuing to grow and adapt their strategy.
Continue Reading Patient Check-Ups Before Checking Out: Partnering to Bring Health Care into the “One-Stop Shopping” Sector

Someone asked me last week what it was like to attend the JP Morgan Healthcare Conference in San Francisco, which started its annual run today. Outside the conference hotel right now is the obligatory lunchtime sidewalk protest with chants of “Personal Health, Not Corporate Wealth,” while inside healthcare industry investors and operators together are chanting “pop health” instead.  The conference again is well attended, with a broad representation of for-profit and non-profit companies from the health services, health information technology and life sciences sectors.  In a sense, it’s the old-style Times Square of the healthcare industry – stand in one spot at the conference long enough and you’ll see almost every major organization walk by.
Continue Reading Day One Notes – JP Morgan Healthcare Conference, San Francisco

In Medical Center at Elizabeth Place v. Premier Health Partners et. al, Case No. 12-cv-26 (S.D. Oh. Oct. 20, 2014), the Southern District of Ohio held that previously-competing health care systems who join together in a revenue-sharing arrangement are incapable of conspiring with each other under Section 1 of the Sherman Act.  This is the latest decision to weigh in on the level of integration required among legally separate entities to be deemed a single economic actor for antitrust purposes, and particularly significant given the rapidly increasing number of collaborations within the health care industry following passage of the Affordable Care Act.
Continue Reading District Court Weighs in on Level of Integration Required to Shield Health Care Collaborations from Section 1 Scrutiny