According to a Centers for Medicare and Medicaid Services (“CMS”) study reported in Health Affairs on March 24, 2020, national health care spending reached $3.81 trillion in 2019 and is projected to increase to $4.01 trillion by the end of 2020.  CMS also projects that by 2028, health care spending will reach $6.19 trillion, and will account for 19.7% of GDP, up from 17.7% in 2018.
Continue Reading Venture Capital And Private Equity Investors Take Note: Primary Care May Be The Next Behavioral Health

On Friday, President Trump announced four executive orders directed at decreasing prescription drug prices by ordering certain actions by the Department of Health and Human Services (“HHS”).  One order – which has received the most negative reaction from the pharmaceutical industry – would create a “most-favored nation” policy to limit the price Medicare Part B pays for certain drugs to the lowest price paid in another Organization for Economic Cooperation and Development country.  The White House did not release the text of this order on Friday and stated that it would not take effect until August 24, or at all if pharmaceutical companies can offer an alternative proposal to substantially reduce drug prices or if Congress acts.
Continue Reading A Shot Across the Bow of the Pharmaceutical Industry: President Trump Issues a Quartet of Executive Orders on Drug Pricing that Might Eventually (OR NEVER?) Take Effect

While traditionally healthcare businesses have tended to look to patent protection, it would behoove them to also think about trade secret protection to protect their valuable inventions.  Given the financial strains on businesses from the COVID-19 pandemic, some businesses may find trade secret protection a cost-efficient alternative to the patent process. Trade secret enforcement also potentially can yield hundreds of millions, sometimes even over a billion, dollars for the trade secret holder.[1] Further, patent protection is not always available.[2]
Continue Reading Admonition To Members Of The Healthcare Industry: Don’t Give Trade Secret Protection The Short Shrift!

On May 18, 2020, California  Senate Bill 977 (“SB-977”) was passed out of the California Senate Health Committee and is now scheduled for its first hearing before the Senate Appropriations Committee on June 1, 2020.   SB-977 as written would subject all acquisitions and affiliations on and after January 1, 2021 by larger health systems, private equity funds and hedge funds of (i) hospitals, (ii) other health facilities, (iii) physicians, (iv) clinics, (v) ambulatory surgery centers or  (vi) laboratories to prior approval by the California Attorney General.  In its current form, SB-977 would require the California Attorney General to withhold his approval from a proposed transaction unless the transaction would (i) increase clinical integration and/or (ii) increase access or availability of healthcare services to underserved populations, and would not otherwise be anti-competitive.  SB-977 would also give the Attorney General the discretion to hold a public hearing on a proposed transaction.  In short, with SB-977, the California Legislature is going far beyond earlier proposals or legislation in other states – including Connecticut and Washington State – that have prior approval requirements for healthcare transactions.

In this article, we consider the forces behind SB-977 – a decade or more of healthcare consolidations and the financial distress being experienced by hospitals and other healthcare providers as a result of the current healthcare emergency – and the potential impact that SB-977 could have on the California healthcare marketplace if it were signed into law in its current form.
Continue Reading Getting Ahead of California’s Post-Pandemic M&A Surge: California Senate Bill 977 Seeks to Expand Attorney General Oversight of Healthcare Acquisitions and Affiliations involving Hospitals, Health Systems, Private Equity Groups, and Hedge Funds

In a highly anticipated opinion in the AseraCare case, issued on September 9, 2019, the Eleventh Circuit Court of Appeals affirmed the district court’s holding that “a clinical judgment of terminal illness warranting hospice benefits under Medicare cannot be deemed false, for the purposes of the False Claims Act, when there is only a reasonable disagreement between medical experts as to the accuracy of their conclusion, with no other evidence to prove the falsity of the assessment.” U.S. v. AseraCare, Inc., No. 16-13004, at *3 (Sept. 9, 2019 11th Cir.) (“Op.”). Although the Court remanded the case to the district court to consider any such “other evidence” the Government might identify in the record, it also made clear that such evidence would need to “link” to specific claims submitted for payment, creating a substantial practical impediment to the Government’s ability to prove falsity in this and similar cases. See Op. at 56.
Continue Reading The Eleventh Circuit Remands AseraCare, But Affirms High Hurdle for Proving Falsity

Where does my prescription come from? Has it been altered or diluted? Can I trust the label? With millions of prescriptions filled each year, quality control and security across the pharmaceutical supply chain seems like a herculean task. In an attempt to slay this proverbial hydra, the Food and Drug Administration (FDA) developed a new pilot program – the DSCSA Blockchain Interoperability Pilot (the “Blockchain Pilot”) – which aims to use blockchain to create a secure electronic, interoperable system that tracks and traces certain prescription drugs as they are distributed in the United States.
Continue Reading What’s in the Bottle? FDA Announces New Blockchain Pilot Program for Tracking Drug Distribution

Though beloved as a service, hospice can be a difficult subject for patients, families, and even caregivers. The recent short filmEnd Game (2018 NetFlix), follows a set of patients, families, and their caregivers through the difficult discussions and choices faced at end of life. It may help facilitate difficult discussions.
Continue Reading Hospice Short Film End Game Up For Academy Award

Tuesday’s midterm elections showed that healthcare is now a top issue among voters, according to exit polls. In an NBC News poll, healthcare was the top issue for a plurality of voters, ahead of the economy, immigration, and gun policy. [1] As voters made their voices heard, they also helped to solidify the position of the Affordable Care Act (“ACA”) nationwide. While the country waits for final vote counts to be tallied, three key takeaways have emerged:
Continue Reading Midterms Bring New Focus to Healthcare

On September 7, 2018, Governor Jerry Brown signed into law Assembly Bill No. 595, A.B. 595, which amends the California Health and Safety Code to increase oversight by the California Department of Managed Health Care (“DMHC”) of health care service plan mergers and acquisitions (M&A). (See, Cal. Health & Safety Code §§1399.65 and 1399.66). The law allows DMHC to reject M&A transactions that DMHC determines will have an adverse impact on, among other things, competition, subscribers and enrollees, and the stability of the health care delivery system. In addition, DMHC will be empowered to impose conditions that it believes will protect subscribers and enrollees and the public interest as a condition of approval of the transaction (as further described below).
Continue Reading New California Law re HMO M&A

It has been widely reported that healthcare mergers and acquisitions are off to a strong start this year after ending a record-breaking year in 2017. In fact, the healthcare press this year has been replete with articles extolling the “good news” about healthcare investment and transaction activity. For example:

  1. As reported by Kaufman Hall, the number of “hospital and health system transactions announced in 2017 totaled 115, up 13% over 2016 and the highest number recorded in recent history.” Kaufman Hall, “2017 in Review: The Year M&A Shook the Healthcare Landscape,” January 29, 2018;
  2. According to data from Bloomberg, the total deal value of healthcare transactions announced in the first quarter of 2018 is approximately $156 billion. “Health-Care M&A Balloons in Busiest Start in More than a Decade,” by Manuel Baigorri (March 28, 2018) (https://www.bloomberg.com/news/articles/2018-03-28/health-care-m-a-booming-in-busiest-start-in-more-than-a-decade). Not surprisingly, Bloomberg’s transaction value data also shows that first quarter 2018 is the busiest first quarter in more than ten years; and
  3. As reported last month by Forbes in, “Why Private Equity Loves Retail Healthcare from 2012 to 2017,” Nirad Jain, Kara Murphy and Jeremy Martin, April 4, 2018, https://www.forbes.com/sites/baininsights/2018/04/04/why-private-equity-loves-retail-healthcare/#4883ce071924, “From 2012 to 2017, the number of deals involving retail health companies—those that operate freestanding health-related outlets like dental clinics or urgent care facilities—has soared, increasing at a compound annual rate of 34% in the North American market.” Citing, the Bain & Company’s Global Private Equity Report 2018 (http://go.bain.com/global-private-equity-report-2018.html), the authors write that the growth in retail healthcare transactions is, in some significant part, a function of the fact that, “retail health is a fragmented, high-margin sector with strong growth characteristics. In a sea of high prices, it still offers targets at reasonable multiples and many opportunities to unlock substantial value.”


Continue Reading The Shape of Healthcare: Blockbuster Mergers, Retail Healthcare, and Marcus Welby, M.D