Photo of 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.

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.

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.

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.

On June 10, 2021, the U.S. Department of Labor Occupational Safety and Health Administration (“OSHA”) announced “an emergency temporary standard to protect healthcare workers from contracting coronavirus.” The standard focuses on healthcare workers that are on the front lines of the fight against COVID-19, aiming to increase protections for those who “continue to be at high risk of contracting the [disease] . . . while they provide us with critical healthcare services.”
Continue Reading OSHA Releases Emergency Temporary Standards to Protect Healthcare Workers from COVID-19 Infection

The U.S. Department of Justice (the “DOJ”) recently settled whistleblower False Claims Act (“FCA”) allegations against The University of Miami (“UMiami”) for $22 million, which resolves claims from three separate lawsuits related to billing practices at UMiami’s off-campus hospital-based facilities (“Off-Campus Hospital Facilities”) and fraudulent claims for laboratory services.
Continue Reading The University of Miami to Pay $22 Million to Settle Medicare False Claims Act Allegations

The COVID-19 pandemic has seen a wave of telehealth policy changes across the nation at both federal and state levels. Such changes have expanded access to health care and addressed underutilization in chronic disease management while minimizing the risk of exposure for individuals seeking care. One such policy change in particular has received widespread attention and support from industry stakeholders and lawmakers alike: expansion of telehealth to include audio-only telephonic communications. However, the longevity of telehealth’s expansion to audio-only services remains uncertain as states and the federal government each pursue revisions to pandemic-era policies and flexibilities.
Continue Reading Hold the Phone: Audio-Only Telehealth Expanding in New York and other States, but National Policies May Lag

In a prior blog post, we discussed CMS’ Hospital Price Transparency Rule at 45 C.F.R. § 180.10 et. seq., effective January 1, 2021 (the “Rule”), which requires hospitals to make public “a machine-readable file containing a list of all standard charges for all items and services.” Specifically, the Rule requires hospitals to post (1) a description of each item or service provided by the hospital; (2) the gross charge that applies to each individual item or service; (3) payer-specific negotiated rates that apply to each item or service for which a payer negotiated rate has been established. Each payer negotiated price must be clearly associated with the name of the applicable third-party payer and plan; (4) de-identified minimum negotiated rates that apply to each item or service; (5) de-identified maximum negotiated rates that apply to each item or service; (6) discounted cash prices that apply to each item or service; and (7) CPT, HCPCS, or other billing codes used by the hospital for purposes of accounting or billing for the item or service.

In a study published on March 16, 2021, Health Affairs found that out of the largest 100 hospitals in the U.S. (by certified bed count), 65 were “unambiguously noncompliant.” 12 of these 65 (18%) did not post any files or provided links to searchable databases that were not downloadable and 53 (82%) either did not include the payer-specific negotiated rates with the name of payer and plan clearly associated with the charges or were in some other way noncompliant. The data informing this study was pulled from late January 2021 to early February 2021.
Continue Reading Recent Study Shows Lack of Compliance With CMS’ Hospital Price Transparency Rule

In a report issued by the Office of the Inspector General (OIG) at the Department of Health and Human Services (HHS) on March 23, 2021 (the “2021 Report”), representatives from 320 hospitals in 45 states, the District of Columbia, and Puerto Rico were interviewed on their experiences responding to the COVID-19 pandemic. Questions were focused on the hospitals’ most difficult challenges in responding to COVID-19, strategies used by the hospitals in addressing or mitigating those challenges, and how the government could best support hospitals responding to COVID-19. This report was a follow-up to a similar OIG pulse survey released about a year ago on April 3, 2020 (the “2020 Report”), which summarized hospitals’ answers to the same questions near the start of the pandemic. The two reports, published one year apart, provide a useful snapshot into how hospital challenges have evolved in responding to the pandemic. Looking at the two reports side-by-side, we compare the challenges hospitals faced in 2020 versus the challenges they are now contending with one year later in 2021.
Continue Reading One Year Later: OIG Reports Describe Evolving Challenges Hospitals Have Faced in Pandemic Health Care Delivery

A recent Fourth Circuit decision, United States v. Mallory (988 F.3d 730), upheld damages and penalties for more than $100 million for violations of the Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)) (the “AKS”) and the False Claims Act (31 U.S.C. § 3729) by a blood testing laboratory and its contracted sales agents.  The Court held that commission payments made by the laboratory to its sales agents (sales companies that, in turn, hired and contracted salespeople to sell the laboratory blood tests), which were based on the percentage of revenue the sales agents generated for the laboratory through marketing services, constituted improper “remuneration” that intended to induce the sales agents to sell as many laboratory tests as possible. The defendants failed to show that the arrangements fit within an AKS Safe Harbor.
Continue Reading Developments Regarding Commission-Based Compensation Arrangements with Independent Contractors

As promised, this is a follow-up to our first blog post on the new federal transparency requirements. In our prior post, we summarized the Hospital Price Transparency rule which went into effect on January 1, 2021, and here we discuss the transparency rules contained in the Consolidated Appropriations Act, 2021 (the “Act”), which apply to both health plans and health care providers.

Beginning January 1, 2022, the Act requires providers (individual practitioners and facilities) to send the health plan a “good faith estimated amount” of scheduled services, including any expected ancillary services and the expected billing and diagnostic codes for all items and services to be provided. This notice then triggers the health plan’s obligation to send enrollees an “Advanced Explanations of Benefits” (“AEOB”) prior to scheduled care (or upon patient request). If the patient is uninsured, the provider must send the notice directly to the patient.
Continue Reading New Federal Transparency Requirements Impacting Health Providers and Plans

This post is part one of two in a series on new transparency requirements impacting both health plans and health care providers.

In an effort to assist patients in understanding the cost of hospital services, the Hospital Price Transparency rule at 45 C.F.R. § 180.10 et. seq., effective January 1, 2021, requires all hospitals to make public the following pricing information:
Continue Reading The Hospital Price Transparency Rule: Is it Worth the Cost of Compliance?

The latest COVID-19 stimulus bill, the American Rescue Plan of 2021 (the “Act”), enacted on March 11, 2021, provides $1.9 trillion in funding for various COVID-19 relief measures. However, while the Act includes many funding provisions, including those funding direct assistance to lower-income individuals and families, expanding “Obamacare” insurance subsidies and availability, increasing federal medical assistance percentage (“FMAP”) rates for Medicaid programs under certain circumstances, supporting public health workforce development, funding technical assistance to skilled nursing facilities (“SNFs”), and bolstering COVID-19 vaccine and testing efforts, it also has a few provisions that create new or directly augment existing financial supports available to providers and hospitals that have sustained losses during the pandemic.
Continue Reading The COVID-19 Provider Funding Tap Begins to Run Dry: The American Rescue Plan Offers Minimal Financial Relief to Non-Rural Providers and Hospitals