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Michelle Chipetine is a counsel in Crowell & Moring’s New York office and a member of the firm’s Intellectual Property and Health Care groups. Michelle’s practice focuses on patent litigation and representing health care entities and not-for-profit corporations on a wide range of transactional, corporate, and regulatory matters. Michelle also maintains an active pro bono practice.

Michelle graduated cum laude from Fordham University School of Law, where she was a legal writing and torts teaching assistant and actively involved with Fordham’s Neuroscience and Law Center. During law school, Michelle worked for Mount Sinai Innovation Partners, where she facilitated the transfer and commercialization of technologies developed by Mount Sinai researchers. Michelle also studied neuroscience at Vassar College, where she graduated cum laude.

In late March 2023, Dr. Paul Koch, the former owner of a chain of Rhode Island ophthalmology practices, agreed to pay $1.1 million to the U.S. Attorney’s Office to settle false claims act allegations.  This case arose from a qui tam complaint brought by two whistleblowers alleging that over a five-year period, Koch paid kickbacks to optometrists to induce referrals for patients for cataract surgeries.  Notably, the settlement included a non-admission clause by Dr. Koch, denying liability and disputing the relators’ entitlement to attorneys’ fees, and the court entered a Stipulation of Partial Dismissal and Consent to Dismissal on Behalf of the United States shortly thereafter.Continue Reading Settling False Claims Act Cases Involves More than Just Cutting a Check to DOJ

For several years now, the United States Department of Justice (“DOJ”) has indicated an increased desire to exercise its dismissal authority over qui tam actions, even over the objections of relators who initially brought the claims.  However, the slight uptick in such dismissals was seemingly stunted while United States ex rel. Polansky v. Exec. Health Res., Inc., 599 U.S. 419 (2023) (which involved the scope of the government’s authority to dismiss False Claims Act (“FCA”) qui tam actions) made its way to the United States Supreme Court (“SCOTUS”). Continue Reading Encouraging Signs that DOJ May Finally Be Using Its Dismissal Authority

In a pivotal ruling that may reshape the landscape of False Claims Act (“FCA”) litigation, the United States Court of Appeals for the Second Circuit adopted a nuanced interpretation of “willfulness” under the federal Anti-Kickback Statute (“AKS”).Continue Reading Significant Implications for FCA Defendants: Second Circuit Clarifies “Willfulness” in McKesson Decision

In a recent landmark decision, the United States District Court for the District of Minnesota dramatically reduced the damages and penalties awarded in a major False Claims Act (“FCA”) case.  United States of America ex rel. Kipp Fesenmaier v. The Cameron-Ehlen Group, Inc., et al., Case No. 13-cv-3003 (D. Minn., Feb. 8 2024) (Dkt. 1086).  The case initially concluded with a staggering judgment of over $487 million against the defendants.  However, after post-trial motions, the court reduced the judgment over 55% to approximately $216 million, citing the Excessive Fines Clause of the federal constitution as a limiting factor.Continue Reading Monumental Reduction in FCA Damages Based on Excessive Fines Clause

The Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) published the General Compliance Program Guidance (GCPG) on November 6, 2023. The GCPG provides updated descriptions of the seven elements of an effective compliance program that health care entities have long relied upon. The new guidance also includes

On July 29, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that updates Medicare payment policies and rates for skilled nursing facilities (SNFs) and enacts changes to the SNF Quality Reporting Program and the SNF Value-Based Purchasing Program beginning in FY 2023.

SNF Payment Rates and PDPM Adjustments

Nursing homes

Last week, the Centers for Medicare & Medicaid Services (CMS) released data—for the first time—reporting on mergers, acquisitions, consolidations, and changes of ownership of Medicare enrolled hospitals and nursing homes over the past six years. This data, expected to be updated on a quarterly basis moving forward, has been lauded as an important step in improving transparency around nursing facility ownership and enhancing nursing home safety and quality of care. In conjunction with the release of CMS’ data, HHS’s Office of the Assistant Secretary for Planning and Evaluation (ASPE) released a related report analyzing the data and examining trends in changes of ownership over the past six years. In its report, ASPE also offers preliminary insights into how the data on ownership changes can support implementing policies bolstering competition in health care as well as ensuring program integrity in Medicare and Medicaid.Continue Reading Changing Hands, Not Washing Them: CMS’ First Report on Nursing Home M&A Data

On November 13, 2020, the Centers for Medicare & Medicaid Services (“CMS”) published a final rule, demonstrating long-awaited efforts to streamline the regulatory framework governing the Medicaid and Children’s Health Insurance Program (“CHIP”) managed care programs.

According to CMS, the purpose of the final rule is to relax certain administrative burdens imposed by the Medicaid managed care rule promulgated by the Obama Administration in 2016. The 2016 rule (the “Mega Reg”), reflecting efforts to modernize the Medicaid and CHIP managed care programs and frustrate widespread fraud and abuse, was the first update to Medicaid managed care regulations in more than a decade.  The following blog post presents a brief summary of the final rule’s key changes.Continue Reading 2020 Medicaid Managed Care Rule Summary

On October 29, 2020, the Departments of Health and Human Services, Labor, and the Treasury (“the Departments”) issued a final rule requiring private-sector health insurers and self-insured health plans to disclose treatment prices and cost-sharing information with consumers.  The Transparency in Coverage rule comes in response to President Trump’s executive order aiming to increase transparency in the healthcare industry. It is slated to become effective on January 11, 2021.

The final rule contains three main parts: (1) requirements for plans and issuers to disclose estimated costs associated with covered items or services furnished by a particular provider; (2) requirements for plans and issuers to publicly disclose reimbursement rates; and (3) amendments to the medical loss ratio program rules to allow issuers to receive credit for enrollees’ savings. Each part is discussed below.

Estimated Costs

First, insurers and employer-sponsored health plans will be required to provide price estimates, including in-network and out-of-network negotiated rates, for health care items and services upon request.  The regulation requires these estimates beginning in 2023 for the 500 most “shoppable” items and services on an internet-based self-service tool (and in paper form, if requested by the participant, beneficiary, or enrollee).  Among the 500 “shoppable services” are mammograms, physician visits, colonoscopies, and various blood tests, biopsies, and X-rays, and the full list is specified in the regulations.  Then, beginning in 2024, price estimates for all remaining items and services offered, including procedures, drugs, durable medical equipment, must be disclosed. The price transparency requirements include disclosure of the following:Continue Reading HHS Finalizes Health Plan Price Transparency Rule

On January 1, 2019, portions of the U.S. Department of Labor’s (DOL) Final Rule expanding the availability of Association Health Plans (AHPs) went into effect. AHPs allow small businesses to band together and negotiate better deals when buying insurance for their members.

The partial government shutdown hasn’t slowed the raging debate over how states are to implement the DOL’s final rule. On December 28, 2018, a federal judge ordered litigation concerning the rule to continue despite the shutdown.

States have reacted to the final rule in dramatically divergent ways. Some states believe that AHPs will make it finally possible for small employers to offer affordable healthcare options for their employees. Other states worry that AHPs will destabilize the individual insurance marketplace. They predict that healthy people will join AHPs because they are less expensive than other insurance options, and this shift will leave sicker people in a smaller pool with higher premiums.  
Continue Reading Taking the Pulse of New Association Health Plans