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Week Ahead in Health Care Law: October 4, 2021

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Sept 30 (Reuters) - (Reuters) - Here are some events of interest to the Health Care Law community this week. All times are local unless otherwise noted.

Monday, Oct. 4

1 p.m. - Four large pharmacy chains are set to face their first trial over the deadly U.S. opioid epidemic. The Ohio counties of Lake and Trumbull allege that oversight failures at pharmacies run by Walgreens Boots Alliance Inc, CVS Health Corp, Walmart Inc and Giant Eagle Inc led to excessive amounts of opioid pills in their communities. Lawyers for the counties and companies are set to deliver opening statements on Monday to a federal jury in Cleveland, where thousands of similar lawsuits are pending before U.S. District Judge Dan Polster.

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The case is In re National Prescription Opiate Litigation, U.S. District Court, Northern District of Ohio, No. 17-md-02804. For the plaintiffs: W. Mark Lanier of The Lanier Law Firm, Frank Gallucci of Plevin & Gallucci, Hunter Shkolnik and Salvatore Badala of Napoli Shkolnik, Jayne Conroy of Simmons Hanly Conroy, Joseph Rice of Motley Rice and Paul Farrell of Farrell & Fuller. For CVS: Eric Delinsky and Alexandra Miller of Zuckerman Spaeder. For Walgreens: Kaspar Stoffelmayr, Brian Swanson, Katherine Swift, Alex Harris, Sharon Desh and Sten Jernudd of Bartlit Beck. For Walmart: John Majoras, Benjamin Mizer, Tina Tabacchi and Tara Fumerton of Jones Day. For Giant Eagle: Robert Barnes, Scott Livingston, Joshua Kobrin and Daniel Stuart of Marcus & Shapira.

Tuesday, Oct. 5

10 a.m. – The 2nd U.S. Circuit Court of Appeals will hear an appeal by a class of investors whose shares in Bristol Myers Squibb fell 16% in August 2016, when the company announced that its existing cancer treatment Opdivo (nivolumab) had not performed as expected in a late-stage clinical trial testing its use as a first-line treatment against the most common form of lung cancer. The shares fell again that October, when BMS revealed study parameters that, according to the plaintiffs, had destined the trial to fail. A federal judge in Manhattan dismissed the plaintiffs’ second amended complaint last year, finding that it failed to adequately plead scienter or, indeed, any material misrepresentation or omission of fact, as required by Section 10(b) of the Securities Exchange Act of 1934. The case is Arkansas Public Employees Retirement et al. v. Bristol-Myers Squibb Co. et al, 2nd U.S. Circuit Court of Appeals No. 20-3716. For APERS: Salvatore Graziano of Bernstein Litowitz Berger & Grossmann. For BMS: Yosef J. Riemer of Kirkland & Ellis.

Wednesday, Oct. 6

11:55 a.m. (ET) – David Godfrey, chair of the ABA’s Commission on Law and Aging, opens the 2021 Virtual National Aging and Law Conference with “Dorothy Was Right: There’s No Place Like Home” – a panel discussion on aging-in-place, housing issues and home- and community-based care. The conference runs through Friday, with three half-day sessions covering topics like guardianship issues, new reporting requirements for legal assistance providers under the Older Americans Act, and “Lightning Trends in Law and Aging,” with panelists including Assistant Secretary for Aging Alison Barkoff of the Health and Human Services Department. For the full agenda and speakers list, go to https://web.cvent.com/event/767f2c20-156e-4fe6-8b0a-e948d0864249/summary

12 noon – The 2nd U.S. Circuit Court of Appeals will consider whether people covered by Medicare can appeal a physician's or hospital’s determination to admit them informally, as outpatients for observation, rather than as inpatients. “Observation status” carries heavy financial consequences for Medicare patients because formal admission as an inpatient is required for hospitalization coverage under Medicare Part A and for rehabilitation services after discharge. After a 2019 bench trial, a federal judge in Connecticut ruled in favor of one category of patients -- those who were initially admitted as inpatients, but whose status was changed following a hospital utilization review required by Medicare – and ordered the U.S. Health and Human Services Department to create an appeals process for them. The 2nd Circuit stayed the order pending the outcome of HHS’ appeal. Both sides have drawn amicus support. The case is Lee Barrows et al. v. Xavier Becerra, Secretary of Health and Human Services, 2nd U.S. Circuit Court of Appeals No. 20-1642. For Barrows et al.: Alice Bers of the Center for Medicare Advocacy. For HHS: Adam Jed, U.S. Justice Department.

Thursday, Oct. 7

9 a.m. – The 5th U.S. Circuit Court of Appeals will again consider whether the government can recoup alleged overpayments by Medicare while the provider awaits a hearing by an Administrative Law Judge – a 90-day period by statute, but a three- to five-year period in real life. A federal judge in Dallas ruled in January 2020 that recoupment of $7.6 million from Family Rehabilitation Inc. during the lengthy wait would be a due process violation. The government argues the case is indistinguishable from Sahara Health v. Azar, which the 5th Circuit decided in its favor last November. However, Family Rehab notes that the government was the appellee in Sahara Health; in this case, the government is the appellant, and must overcome the district court’s finding that ALJ hearings are necessary to safeguard against a high rate of error in the government’s audits and pre-ALJ reviews. The case is Family Rehabilitation Inc. v. Xavier Becerra, Secretary of Health and Human Services, 5th U.S. Circuit Court of Appeals No. 20-10271. For Family Rehab: Rebekah Plowman of Stimlabs; Chesley McLeod of Arnall, Golden & Gregory. For Becerra et al.: Joshua Salzman, U.S. Justice Department.

Know of an event that could be included in Week Ahead in Health Law? Contact Brendan Pierson at brendan.pierson@thomsonreuters.com

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Reporting by Barbara Grzincic; additional reporting by Nate Raymond

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