District Court Invalidates Medicare GME Regulation and Orders CMS to Recalculate Hospitals’ Medicare Reimbursement

Teaching hospitals should find that their Medicare reimbursement for training physicians will be a little sweeter thanks to a decision by the United States District Court for the District of Columbia.  Milton S. Hershey Medical Center, et al. v. Becerra, No. 19-2680 (D.D.C. May 17, 2021).  The hospitals challenged a 1997 regulation that set out a formula for counting the number of full-time residents and fellows. Under the Medicare statute, the government reimburses hospitals for salaries and administrative costs directly related to graduate medical education (“GME”). The statute contains a formula for determining the weighted number of full-time equivalent residents (“FTEs”) employed by the hospital.  The formula weights FTEs based on the length of their employment, and imposes a cap on the number of FTEs that a hospital can count for Medicare reimbursement. 42 U.S.C. § 1395ww(h)(3-5).  The formula also counts residents differently from fellows, who have completed a residency in a specialty and are receiving further training in a subspecialty; for purposes of the FTE count, the weighting factor for residents is 1.0 and for fellows the weighting factor is 0.5. 42 U.S.C. § 1395ww(h)(4)(C).  Congress also capped the number of FTEs that can be counted for purposes of Medicare reimbursement at the FTE count for that hospital as of December 31, 1996.

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Podcast: Federal and State Cannabis Rules Are Moving in Different Directions – Diagnosing Health Care

In this episode of the Diagnosing Health Care Podcast:  Federal and state cannabis regulation and enforcement appear to be moving in different directions. While the Food and Drug Administration (“FDA”) has broadened its net to target businesses making claims that their products can treat specific conditions, a growing number of states have passed bills that, among other things, legalize adult-use cannabis.

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EEOC weighs in with updated guidance on vaccine mandates, incentives and more

Responding to COVID-19 was uncharted territory for many employers. The EEOC helped guide employers through many challenging employment aspects of the pandemic with regular updates to its Technical Assistance document, What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws. However, since addressing just a few vaccine-related issues in December 2020, the EEOC has been silent for months. With questions mounting, employers and business groups have clamored for answers from the EEOC on critical issues such as vaccine mandates, incentives, proof of status, and confidentiality. Now, with progress on vaccines well underway and many employers implementing return to office plans, the EEOC finally weighed in with updated guidance on May 28, 2021. Read more…

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Defendant Aventis Pharma Awarded Over $17.2 Million in Attorneys’ Fees in False Claims Act Case

In a move that reminds us that successful defendants can—and should—seek attorneys’ fees in the right case, a magistrate judge in the U.S. Court of Appeals for the Ninth Circuit awarded pharmaceutical company Aventis Pharma SA (“Aventis”) attorneys’ fees in a False Claims Act (“FCA”) case brought by a competitor, Amphastar Pharmaceuticals Inc. (“Amphastar”). The FCA contains a fee-shifting component, permitting prevailing parties to recover attorneys’ fees from the opposing party—but the playing field is not equal. This fee-shifting provision entitles a prevailing plaintiff to an award of reasonable attorneys’ fees and costs, regardless of whether the government elects to intervene in the case. 31 U.S.C. § 3730(d)(1)-(2). A defendant, on the other hand, can only be awarded attorneys’ fees in cases in which the government has declined to intervene and where the defendant can show that the opposing party’s action was “clearly frivolous, clearly vexatious, or brought primarily for purposes of harassment.” 31 U.S.C. § 3730(d)(4).

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Restaurants with unconfirmed bankruptcy plans may seek emergency dismissal of bankruptcy case to gain access to Restaurant Revitalization Funds

The Restaurant Revitalization Fund, which is a $28.6 billion federal fund for struggling restaurants that was established as part of the $1.9 trillion American Rescue Plan passed on March 6, appears to be having an unintended effect on bankrupt restaurants trying to apply while their bankruptcy cases are pending. We previously summarized the key terms of the Restaurant Revitalization Fund and details regarding the portal and the initial applicants for the fund can be found here. Unlike the Paycheck Protection Program that provided loans throughout the COVID-19 pandemic, the Restaurant Revitalization Fund (the RRF) offers substantial grants, not loans, to restaurants that have struggled for the past year, and restaurants may use the grants to pay for payroll expenses, mortgage payments, rent utilities, supplies, and food and beverage expenses, among other costs. Like the Paycheck Protection Program, however, funds will be distributed on a first-come, first-serve basis, and companies that are currently in chapter 11 bankruptcy are not eligible for grants from the RRF unless the bankrupt company already has a confirmed plan of reorganization. Although companies in bankruptcy were not eligible for PPP loans for much of last year, the Small Business Administration recently revised its guidelines in April 2021 to provide the companies in chapter 11 bankruptcy are eligible for PPP loans if they have a confirmed reorganization plan. Read more…

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OIG Issues Favorable Advisory Opinion on Ambulatory Surgery Center Joint Venture

The U.S. Department of Health and Human Services’ Office of Inspector General (“OIG”) recently issued Advisory Opinion No. 21-02, regarding a joint investment by a health system, a manager, and certain surgeons in an ambulatory surgery center (“ASC”) (the “Proposed Arrangement”). According to a national survey, most hospitals and health systems are planning to increase their investments in ASCs and anticipate converting hospital outpatient departments to ASCs. Many hospitals with ASCs operate the ASCs as physician joint ventures. As payors and patients continue to show interest in having outpatient procedures performed in ASCs, there is an expected trend to see an increase in investments and joint ventures in ASCs therefore making the Advisory Opinion particularly noteworthy.

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Lidings Wins Trademark Battle for “Miloserdie” Aid Service

Lawyers of the Lidings Intellectual Property practice have successfully represented interests of the Russian “Miloserdie” (eng.:Mercy) aid service in a trademark protection case. The work was done pro bono.

An entrepreneur used a trademark similar to the trademark of our client – the “Miloserdie”. The client, whose logo was registered a year earlier, for six months tried to settle the issue out of court, pointing out to the entrepreneur that it was inadmissible to copy the logo. However, did not achieve an understanding and had to go to court.

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Podcast: Are Vaccine Passports the Key to Reopening? – Diagnosing Health Care

In this episode of the Diagnosing Health Care PodcastThe vaccine passport has been a major topic of discussion as businesses and governments consider how to balance privacy and safety through the rollout of the COVID-19 vaccine. Epstein Becker Green attorneys Patricia WagnerAlaap Shah, and Jessika Tuazon discuss the privacy and security concerns companies must weigh as they consider developing or implementing vaccine passports, such as the collection and use of an individual’s personal health information. As state governments and the private sector take the lead on developing vaccine passport initiatives, it is imperative that businesses implement better privacy and security practices to mitigate or manage risk.

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Video: CDC Guidance for the Fully Vaccinated, NY HERO Act, ABC Test, and FAAAA Preemption – Employment Law This Week

As featured in #WorkforceWednesday: This week, we focus on the Centers for Disease Control and Prevention’s (CDC’s) new guidance for vaccinated individuals and what it means for accommodations.

Employers Navigate New CDC Guidance for Fully Vaccinated Individuals

Last week, the CDC updated its guidelines to state that it is safe for fully vaccinated people to resume normal activities without masks or social distancing “except where required by federal, state, local, tribal, or territorial laws, rules, and regulations, including local business and workplace guidance.” Attorneys Shira Blank and Susan Gross Sholinsky explain what this means for employers and businesses that are places of public accommodation.

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Health Care Providers with Claims Arising Out of New York’s Failed Health Republic Insurance Co. to Be Paid in Full

In December 2015, we wrote about the many failed health insurance co-ops created under the Affordable Care Act (“ACA”), and the impact of those failures on providers and other creditors, consumers, and taxpayers. At that time, co-ops across the country had more than one million enrollees. As of January 2021, there were roughly 120,000 enrollees in three remaining co-op plans. Nonprofit co-op insurers were intended to increase competition and provide less expensive coverage to consumers. However, low prices, lack of adequate government funding, restrictions on the use of federal loans for marketing, and low risk corridor payments from the Centers for Medicare & Medicaid Services created financial challenges for these insurance plans

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