In an important decision limiting the reach of the Federal Anti-Kickback Statute (42 U.S.C. 1320a-7b(b)) (“AKS”) and its application to violations of the False Claims Act (31 U.S.C. 3729, et seq.) (“FCA”), the U.S. Court of Appeals for the Sixth Circuit (“Sixth Circuit”) recently contended that, “[w]hile the word remuneration may be broad, it customarily requires a payment or transfer of some kind,” and mandated “but-for” causation standard for determining whether claims paid by Federal health care programs were tainted by an AKS violation such that they violated the FCA. See U.S. ex rel. Martin et al. v. Hathaway, et al., Case No. 22-1463, at 11 (6th Cir.) (appeal from 1:19-cv-00915, ECF Doc. No. 108 (W.D. Mich.)) (emphasis added).
Edward S. Kornreich
Past long-standing chair of Proskauer’s Health Care Department, Ed Kornreich is a recognized authority on the legal, regulatory and business issues related to health care services.
Areas of Concentration
Ed works primarily on health care transactions, regulatory compliance, health care payment and governance issues for varied providers (both for-profit and not-for-profit), vendors, GPOs, distributors and entrepreneurs. His approach combines sensitivity to meeting regulatory business goals with a comprehensive and realistic assessment of the health care environment, and he is particularly experienced in dealing with the complex issues related to integrated health care systems.
Industry Experience
After working for the Legal Aid Society, Ed entered private practice, where he helped represent a major public hospital corporation in a series of reimbursement disputes with the state and federal governments, and counseled New York area hospitals and nursing homes on reimbursement and operational issues. Thereafter, Ed served as General Counsel of St. Luke's-Roosevelt Hospital Center, one of the largest teaching hospitals in New York. After leaving St. Luke's-Roosevelt Hospital Center, Ed joined Proskauer as a Partner in 1990.
Thought Leadership
Ed frequently writes and lectures on Medicare and Medicaid reimbursement, health care integration, not-for-profit law and corporate governance issues, and the application of federal and state anti-kickback and “Stark” laws to health care transactions.
Challenges to the No Surprises Act Continue: The Latest includes a Challenge to a 600% Increase in Administrative Fees
On February 6, 2023, a judge for the United States District Court for the Eastern District of Texas (“Texas District Court”) ruled in favor of the Texas Medical Association (“TMA”) and against the United States Departments of Treasury, Labor, and Health and Human Services (the “Departments”) over a challenge to…
President Biden Announces the End of the COVID-19 Emergencies: The Health Care Industry Has Less Than Four Months to Prepare
After multiple extensions over the past three years, on Monday, January 30, 2023, President Biden announced that the COVID-19 national emergency and public health emergency (“PHE”) will officially end on May 11, 2023.
However, with less than four months until that date, providers must quickly review their…
The Saga of the No Surprises Act Continues to be … Surprising
We previously noted that the regulations implementing the No Surprises Act (“NSA”) appeared to be inconsistent with the NSA because they seemed to establish the qualifying payment amount (“QPA”) as the appropriate payment amount to be used in arbitrations by certified IDR entities (viz. the regulation-established independent dispute resolution (“IDR”) process) between plans and providers, and that the United States District Court for the Eastern District of Texas (“Texas District Court”) vacated portions of the NSA regulations relating to the QPA for purposes of the IDR process. The Federal government recently responded to the Texas District Court—by removing such portions of the NSA regulations.
New York State to Fund Bonuses for Certain Healthcare Workers as Part of State Budget
As part of the Fiscal Year 2023 New York state Executive Budget legislation, $1.2 billion in funding has been allocated for the payment of bonuses for certain “frontline” healthcare workers.
With the stated goals to “recruit, retain, and reward health care and mental hygiene workers,” the provision – located within Part D of the Health and Mental Hygiene Bill, as amended – requires the state Commissioner of Health, in consultation with the state Commissioner of Labor and the Medicaid inspector general, to develop procedures to facilitate payment of claims to covered employers for the purpose of funding worker bonuses in accordance with the provision’s requirements. Bonus amounts will be commensurate with the number of hours worked by covered workers during designated vesting periods up to a total of $3,000 per covered worker.
No Surprises Act’s Regulation Establishing QPA as Presumptive Payment Amount Vacated by District Court
We previously noted that the No Surprises Act (NSA) regulation’s establishment of the presumption that the qualifying payment amount (QPA)—generally, the median payment by the plan to providers in the region—is the appropriate payment amount in arbitrations between plans and providers under the NSA did not appear to comport with…
Failure to Disclose Speakers at Protected QA Meeting Loses Protection for All Speakers
Recently, in Siegel v. Snyder, Slip.Op. 07624, New York’s Appellate Division, Second Department interpreted New York’s peer review/quality assurance confidentiality statute in a manner that may require modifications to the standard documentation of such meetings. New York’s Education Law 6527(3) shields from disclosure “the proceedings [and] the records relating to performance of a medical or a quality assurance review function or participation in a medical . . . malpractice prevention program,” as well as testimony of any person in attendance at such a meeting when a medical or quality assurance review function or medical malpractice prevention program was performed (see Logue v Velez, 92 NY2d 13, 16-17). Public Health Law 2805-m(2) affords similar protection from disclosure for “records, documentation or committee actions or records” required by law, which includes peer review activity.
Physician Fee Schedule Final Rule for Calendar Year 2022 – CMS Cuts Rates and Extends Telehealth
On November 2, 2021, the Centers for Medicare and Medicaid Services (“CMS”) issued its Calendar Year (CY) 2022 Physician Fee Schedule (“PFS”) Final Rule. In this post, we sample some key highlights from the Final Rule.
CMS Appears to Soften Co-Location Restrictions in Newly-Revised Guidelines
In a November 12, 2021 revision of its prior draft guidelines for hospital co-location compliance with Medicare conditions of participation (COP) for hospitals (QSO-19-13), CMS has apparently softened its approach to co-location. The modified guidance is less prescriptive and appears more practical and supportive of co-location where appropriate. In July…
OIG Publishes Favorable Advisory Opinion Related to the Employment Safe Harbor
In an advisory opinion posted November 10, 2021 (AO 21-15), the Office of the Inspector General of the United States Department of Health and Human Services (OIG) appeared to soften a disturbing position that it had taken in 2012 regarding the employment safe harbor.
The issue is the…