Author: WadeEmmert

Tom Greeson, writing for ReedSmith:

Although it is possible to enter into business ventures with referral sources, care needs to be taken to ensure that the arrangement does not run afoul of the Medicare fraud and abuse laws. This month, the U.S. Health and Human Services Office of the Inspector General (OIG) refused to give its blessing to such a venture. In Advisory Opinion 23-05, the OIG reviewed the structure of a venture between surgeons who would become investors and an entity that would supply these same surgeons with intraoperative neuromonitoring (IONM) services.

Lily Hay Newman, writing for Wired.com and Ars Technica:

The Advanced Research Projects Agency for Health (Arpa-H), a research support agency within the United States Department of Health and Human Services, said today that it is launching an initiative to find and help fund the development of cybersecurity technologies that can specifically improve defenses for digital infrastructure in US health care. Dubbed the Digital Health Security project, also known as Digiheals, the effort will allow researchers and technologists to submit proposals beginning today through September 7 for cybersecurity tools geared specifically to health care systems, hospitals and clinics, and health-related devices.

Douglas A. Grimm, Gayland O. Hethcoat II, writing for ArentFox Schiff:

In Advisory Opinion No. 23-04, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) analyzed certain proposed changes to the functionality of a health care technology company’s online provider marketplace. As in an earlier 2019 opinion, OIG concluded that the company’s business model would not result in unlawful kickbacks and patient inducements.

Andrew Lacy, Arman Oruc, John Goheen Kevin Walsh, and Andrew Jensen, writing for Goodwin Procter:

In the second quarter, the US antitrust agencies continued efforts to bolster their aggressive enforcement agenda by rewriting long-standing policies and procedures, including sweeping revisions to Merger Guidelines, significant changes to the HSR filing process, and withdrawing long-established antitrust healthcare guidance.

Pressure on PBMs continued to mount as the FTC expanded its study of the industry and withdrew previous advocacy statements and market studies related to PBMs.

The FTC continued to challenge major healthcare mergers, including the ongoing challenge to Illumina/Grail and a new challenge to IQVIA/Propel.

Beyond merger review, the FTC has not relented in its focus on state COPA laws, which may intensify enforcement actions in this space. Further, two states enacted notification laws for healthcare transactions that will require additional information and extend the timeline for regulatory approval.

Dallas Morning News:

Texas officially ousted the organization from the state’s Medicaid program in 2021 after four years of trying and a subsequent legal battle.

Planned Parenthood continued to collect Medicaid payments from the state during legal appeals, $17 million the state says the health care group should now pay back, in addition to fines that far exceed the amount the state said Planned Parenthood owes in reimbursement funds. Planned Parenthood said the total judgment could be greater than $1 billion.

Now-suspended Texas Attorney General Ken Paxton filed the lawsuit last year under the False Claims Act, which establishes liability for health care fraud and allows fines for every incorrect payment.

Joseph J. Lazzarotti, writing for JacksonLewis:

A recent study suggests that the likelihood for hospitals to experience a data breach doubles during the year before and after a merger. As some expect an increase in hospital mergers in the coming year, one can expect the number of healthcare data breaches to increase.

According to the research, Nan Clement, a Ph.D. candidate in economics in the School of Economic, Political and Policy Sciences in the University of Texas at Dallas looked at reporting on data breaches from the Office for Civil Rights during the period 2010 to 2022. Based on her analysis, for the two-year period surrounding a transaction closing (one year before and after the closing date), the chances of a data breach was 6%, compared to 3% for hospitals that merged but were outside that two-year period.

By Noah Tong, for Fierce Healthcarel:

Among numerous tweaks, CMS reduced the beneficiary alignment minimum for new entrant accountable care organizations from 5,000 to 4,000. It also reduced minimums for high needs populations. A 10% buffer will be applied across all ACO types, allowing an ACO to temporarily drop below the new beneficiary minimum, but an ACO cannot remain below the threshold for more than one of the model’s remaining years, according to the newly released standards.

By Ryan P. Blaney & Jonian Rafti, for Proskauer:

The Final Rule codifies the prohibition on “information blocking” introduced by the 21st Century Cures Act (“Act”), which was enacted on December 13, 2016. In the Act, “information blocking” was defined as any activity that, in part, is “likely to interfere with, prevent, or materially discourage access, exchange, or use” of electronic health information (“EHI”).[1] The Final Rule provides an enforcement process for alleged information blocking violations by health information networks, health information exchanges, and developers of health IT certified by the HHS Office of the National Coordinator for Health Information Technology (“ONC”). Enforcement of the information blocking penalties will begin on September 1, sixty days after publication of the final rule in the Federal Register.

By Wendy Arends, Mark Tobey & Kelsey Toledo, for HuschBlackwell:

The draft Merger Guidelines were published on July 19, 2023, by the Agencies just weeks after the FTC issued newly proposed rules under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR). The Merger Guidelines represent a significant departure from the 2010 Horizontal and Vertical Merger Guidelines, and the proposed HSR rules represent the first time the HSR process has been substantively updated in over 40 years.If implemented in their current form, both will have the effect of making the merger review process lengthier, more complicated, and more burdensome for virtually all companies, including those operating in the healthcare industry. The Agencies are seeking comments on the Merger Guidelines through September 18, 2023, and the FTC is currently accepting comments on the Proposed HSR Rules, extending the comment period until September 27, 2023.