What the DOJ and FTC Merger Guidelines mean for healthcare M&A–review of the Epstein Becker Green podcast

April 23, 2024 | by

Are you in the (mostly) lucky group of companies seeking to buy or be bought? This podcast is a ‘must hear’ as likely you’ll be affected. Healthcare law firm Epstein Becker Green’s roundtable podcast in the ‘Diagnosing Health Care’ series is their half-hour condensed view on the new Federal Merger Guidelines that the Department of Justice (DOJ) and the Federal Trade Commission (FTC) finalized last 18 December. Their view on how it will affect healthcare organizations is not too different from your Editor’s lengthy review of the DOJ/FTC document published on 20 December. The DOJ/FTC end-of-year drop perhaps (ahem) was timed to bury the bad news, drowning it in a punch bowl of good cheer or in holiday busy-ness.

This Editor (note: not a lawyer nor do I play one on TV or YouTube) took the view that it was that it was a whole scuttle of coal for healthcare holiday stockings (right) and that it would discourage much of 2024’s healthcare M&A until companies figured what mergers would likely past muster, among other predictions. The EBG folks mostly agree. They also point out that the final Guidelines’ language is “more aggressive” than the draft that many healthcare organizations took issue with–what the article referred to as “substantially more restrictive language and interpretation”. There are some wins from the draft, but much of the language, especially on vertical mergers, simply moved into one or another of the 11 Guidelines. 

The EBG team on the podcast (available for play on the web page and download) are Trish Wagner, John Steren, and Jeremy Morris, moderated by Dan Fahey. Below are some key points made by the team on the podcast. Your Editor recommends that you pull up our 20 December article as a reference to the specific Guideline references they make.

  • Background: Horizontal merger Guidelines were last updated in 2010. Vertical merger Guidelines were issued in 2020 but later rescinded. These new Guidelines apply to both horizontal and vertical mergers and acquisitions. US antitrust is based on three acts passed by Congress: The Sherman Antitrust Act (1890), the Clayton Act (1914), and the Federal Trade Commission Act of 1914, now in US Code Title 15. The Guidelines since then are based on them as well as case law.  (From the wrapup) Courts tend to be very deferential to the Guidelines.
  • The wording of Guideline #8, When a Merger is Part of a Series of Multiple Acquisitions, the Agencies May Examine the Whole Series, is both interesting and aggressive in that it will be considered and opens up a pattern of acquisitions. This can be by private equity (PE) or other owners.
  • Guidelines #1, Mergers Raise a Presumption of Illegality When They Significantly Increase Concentration in a Highly Concentrated Market, and 2, Mergers Can Violate the Law When They Eliminate Substantial Competition Between Firms, impact hospital mergers. Prior merger guidelines focused on highly concentrated markets using a point system (HHI, the Herfindahl-Hirschman Index, is a common measure of market concentration). This measure sets a lower bar.
    • To trigger #1, a market share above 30% and an HHI over 100 can trigger it even in unconcentrated markets.
    • On #2, elimination of direct competition is maybe in and of itself harmful
  • Guideline #6, Mergers Can Violate the Law When They Entrench or Extend a Dominant Position: for horizontal mergers, ‘entrench’ is in practice the operative term, whereas ‘extend’ applies mainly to vertical mergers. Companies will have to demonstrate that the beneficial competitive effects outweigh the anticompetitive, especially when involving consumers. And they will have to demonstrate why the merger is necessary. 
  • Wrapping up:
    • Ms. Wagner: the Guidelines don’t have the force of law, but they do have impact because they are about the process on how mergers are evaluated. Courts have been very deferential to the Guidelines.
    • Mr. Morris: hospital leaders will have to contemplate this “huge change in a moment” which he questioned. He emphasized that organizations involve their antitrust counsel now even earlier than previously.
    • Mr. Steren: “healthcare has a bullseye on its back”. It is immediately more restrictive. It fits right in with what current enforcers do in trying to bring “persuasive authority” to bring new, novel, cases into court. He seconded Mr. Morris’ last remark.

This Editor, as the Canary in the Coal Mine, will assume that UnitedHealth Group and others have already anticipated that they will have difficulty now making new acquisitions, obtaining approvals for ones that haven’t been finalized, or making quick sales of units they no longer want (Walgreens). Hospitals will find that divestiture and regional mergers will be discouraged. Acquirers who’ve been concentrating on filling out their platforms with vertical acquisitions may find that these Guidelines are also written to trip them up–and once tripped, each Guideline knocks on another. (For other predicted consequences, see the 20 December article.)

Telehealth reimbursement: a major growth obstacle overcome this year?

March 4, 2016 | by

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/03/Hurdle.jpg” thumb_width=”150″ /]Will 2016 be the year where the hurdles are jumped? Telehealth systems and platforms are becoming more comprehensive and compatible with mobile technologies. While there are still discussions (arguments!) as to telehealth remote patient monitoring effectiveness in care models, with the occasional naysaying short-term or IVR study ‘proving’ RPM doesn’t work, the long-term positive VA Home Telehealth results since 2003, and the large body of research prove otherwise when integrated within a chronic or transitional care model. Yet at $14 million or .0025 percent, it was in 2014 a tiny part of Medicare payments because of CMS’ emphasis on rural telehealth at that point (and still). Medicaid (state programs for low-income children and adults under CMS oversight and administered through private payers) is more generous, with most states providing some payment and some having parity (with in-person visits) regulations.

A retrospective look at telehealth reimbursement is in a just-published paper by the Health Care Cost Institute (full PDF of report) which analyzed thousands of claims from four major insurers (Aetna, Humana, Kaiser Permanente and United Healthcare).to track trends in telehealth billings from 2009-2013. Key findings are summarized by senior counsel René Quashie of leading health tech law firm Epstein Becker Green in this article. It’s evident that the private payer sector didn’t exactly lead the way on commercial adoption of telehealth and telemedicine.

Here, the public sector is forcing change. Medicare rules on chronic care management changed for year 2015 to permit telehealth integration, and while complex (and not especially generous), CMS has further expanded them for ACOs in the Medicare Shared Savings Program (MSSP) and for new Next Generation ACOs. Yet only 20 percent of ACOs in the 2015 MSSP program actually used telehealth in care programs.

You can understand why from practices’ past experiences with payers. Becker’s Hospital Review cites from excerpts that while telehealth claims reimbursement on average rose 2009-2011 from $60 to $68/visit, in 2013 they dropped precipitously to $38. For all the hand-wringing over mental health, psychiatrists get the short end once again: a diagnostic interview exam (which is generally 1-2 hours if not more) cost $200 via telehealth (telemedicine) and $288 when the exam was conducted in person, but reimbursement was $77 and $105 respectively. After needing to invest in equipment and software, it’s understandable why physicians don’t look forward to getting paid less for their trouble.

But the argument is that things are changing for the better, and that is advocated by Nathaniel Lacktman, partner of tech law firm Foley & Lardner in his optimistic article in Advance Executive Insights, which maintains that 2016 is going to be the Year of Telehealth and remote patient monitoring. (more…)

2016: will telehealth catch on or stagnate, due to factors out of control?

November 25, 2015 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/11/Robert-Graham-Center-logo.jpg” thumb_width=”150″ /]Updated. Reviewing the Robert Graham Center study summarized by Editor Chrys last week, René Quashie of Epstein Becker Green, perhaps the leading law firm in the health tech area, opines that despite the great progress made by telehealth (telemedicine/virtual consults, but also remote patient monitoring), “state legal and regulatory issues, reimbursement, and provider training and education continue to be serious barriers to wider adoption of telehealth. And until the landscape evolves to address these barriers, telehealth adoption is likely to stagnate despite the great promise of telehealth holds as a tool to improve quality and access.” Yes, that old FBQ* (actually the top two) continues to be as true now as five years ago. While in closing Mr Quashie puts his trust in the ‘pull’ factor of consumers and patients “who will continue to demand better access and more innovative delivery models outside the conventional office visit,” this Editor is far less sanguine, despite having used a virtual consult app recently. It was turned to more out of sheer frustration–time pressure (work, travel), being unable to secure a timely visit with a specialist (no one seems to be taking new patients!) despite good (non-Obamacare) medical coverage, and a condition which was eminently photographable (plus $40 at hand). National Law Review  * The Five Big Questions (FBQs)–who pays, how much, who’s looking at the data, who’s actioning it, how data is integrated into patient records.

Then again, if you read Health Populi and believe Gallup’s polling (based on a slightly skewed question), a majority of Americans aren’t thinking about delivery models or telehealth at all. They’re unhappy, and would like to hand the whole hot mess over to the government when asked if “government is responsible for ensuring that people have health insurance.” Yet the Affordable Care Act, now two years in, was supposed to do exactly that by forcing everyone to pay for a healthcare policy or else pay a punitive tax. Too many did the math; the tax penalty was cheaper, especially for those Young ‘n’ Healthy Invincibles with slim purses and other things to spend on. They were the ones who were expected to pony up premiums, use few services and generally prop up the system.

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/11/shockedshocked.jpg” thumb_width=”150″ /]Now the American populace are shocked, shocked to find that out-of-pocket costs are way up and access is down. The same Health Populi article cites Fair Health’s spring 2015 consumer survey, finding that 33 percent of American patients felt that their out-of-pocket costs were ‘much more than expected’, with an additional 17 percent in the ‘somewhat’ category–a total of 50 percent. The contradiction of government control versus spending (and actuarial) reality is, in this Editor’s opinion, not going to be solved easily or well.

As to the wisdom of government involvement, there’s another developing and embarrassing ACA Big Fail.  (more…)

FDA’s ‘ossification tango’ side 2: what’s the social cost?

October 23, 2015 | by | 1 Comment

Catching up in the back file of articles is another in Bradley Merrill Thompson’s (Epstein Becker Green) series in Mobihealthnews on how the FDA is biased, by its very structure, against novel healthcare technology even if low risk. He further reflects on what’s truly novel, and what’s not. ‘Novel’ means Class III clearance and potentially millions of dollars. to gain it. He reckons that 80 percent of new digital health technology doesn’t qualify as ‘new’ in a regulatory sense–it may be ingenious in transferring the color reading of a test strip to, for instance, a smartphone and an analytic back end. All the new technology has to do is to demonstrate equivalence to the clunky traditional test–in other words, incremental improvement. What he’s worried about is the 20 percent that don’t fit any FDA classification, in particular software that automates what professionals do, repurposing non-healthcare technology for healthcare use (e.g. videogames for ADHD) or algorithms that automate what’s been done manually through a different method. The social cost is that the most in need, who would benefit from novel health tech that cuts cost and improves quality for individuals and populations (that old Triple Aim), will forever be blocked from having it by regulation. “We need a new paradigm where new technology is quickly evaluated for potential risk, and placed promptly into an appropriate regulatory category.”

There are certainly regulatory parallels ex-US. Much more here to ponder for your Weekend Reading.

Previously and related by Mr Thompson: Avoiding the FDA health IT-medical device regulatory trap for general IT companies, FDA, new technology approval and the Ossification Tango

FDA, new technology approval and the Ossification Tango (US)

September 22, 2015 | by

When it comes to new technologies–and drugs for that matter–the worst thing that can happen to your invention is to receive a letter from FDA that you have been classified into Class III. Based on regulations passed by Congress in 1976, there are three FDA classes primarily based on device risk. Exception: Class III. Anything not ‘substantially equivalent’ to an existing device is automatically put into Class III, regardless of risk level. Author and health tech legal advocate Bradley Merrill Thompson of Epstein Becker Green takes a comprehensive review at this flawed and outdated system that puts groundbreaking health tech at an extreme disadvantage in his latest article on regulation in Mobihealthnews. (more…)

Avoiding the FDA health IT-medical device regulatory trap for general IT companies (US)

September 1, 2015 | by

If you are an IT company in the US or internationally with services which could be useful to healthcare companies or practitioners, it’s easy to be overly specific and stray into FDA-regulated territory. The always-informative Bradley Merrill Thompson of the Epstein Becker Green law firm delineates the fine regulatory line that general purpose IT companies must observe when working with healthcare customers. First there is intended use, based on how the manufacturer intends its customer to use the product; if the customer uses it for the diagnosis or treatment of disease or other conditions, FDA will regulate it as a medical device. This is less clear than it seems, and Mr Thompson explores where a general IT company can, in the old PR adage, ‘say it safely’ and avoid falling into the unwanted medical device trap by avoiding medical feature and advice claims, and keeping the context away from medical use. The Journal of mHealth (August)–online version, optional PDF download. Hat tip to Mr Thompson via the Continua LinkedIn group. Other articles of interest in the JMH are: Scottish company HCi Viocare and its ‘smart insole’ pressure sensors for foot ulcer detection following, Northwestern University’s research around patterns of smartphone usage detecting depression (page 19) and a lengthy article on transforming patient data into actionable insights (page 34).

The PROTECT Act for HIT doesn’t: mHealth Coalition

March 6, 2014 | by

The mHealth Regulatory Coalition, which is a four-year-old alliance of legal and software companies in the health IT/software area, and whose most vocal spokespersons are well-known industry legal counsels Brad Thompson and Kim Tyrrell-Knott of Epstein Becker Green, has come out against the PROTECT Act (S 2007). PROTECT, which was proposed by Senators Fischer and King, would limit FDA regulation of certain ‘low-risk’ clinical software in the interest of fostering innovation and reducing regulatory burden. Original reports indicated that this responsibility would be transferred to the National Institute of Standards and Technology (NIST) [TTA 28 Feb]. According to Mr. Thompson, “The rush to avoid expert reviews of complex technologies with far-reaching health ramifications ignores the fact that we cannot separate the high risk from the low risk apps using broad terms in legislation.” His example: a theoretical smartphone app designed to diagnose melanomas from photos. PROTECT is being supported by IBM, athenahealth, Software & Information Industry Association, Newborn Coalition and McKesson. The bill also would exempt certain health IT software from being charged a 2.3% medical device tax, which is perhaps the ‘long game’ being played here by the aforementioned companies, as most Washington watchers give the bill as it stands little chance of clearing both houses of Congress and a congressional committee, much less being signed into law. The question remains: how best to speed less clinically significant wellness software to market without logjamming FDA.  iHealthBeat summary, Clinical Innovation + Technology, MRC press release