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Nation’s First Conviction Under EKRA

Last month, the Department of Justice announced its first ever guilty plea under the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”). This came following an investigation conducted by the U.S. Department of Health and Human Services, Office of Inspector General as well as the Kentucky Office of Attorney General, Medicaid Fraud Control Unit. The investigation uncovered that a Kentucky woman, Theresa C. Merced, had solicited kickbacks from a toxicology laboratory in exchange for urine drug testing referrals. She then lied about the misconduct and the kickbacks that she received when confronted by law enforcement. Thereafter, Ms. Merced attempted to cover her tracks by requesting an alteration of certain financial records.

Ms. Merced appeared before the United States Attorney’s Office for the Eastern District of Kentucky and pleaded guilty to one count of violating EKRA, 18 U.S.C. § 220, among other charges. Sentencing in this case is scheduled for May 1, 2020 and Ms. Merced faces up to 20 years in prison and a maximum fine of $250,000.

On October 5, 2018, the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”) was signed into law as part of the federal government’s ongoing efforts to address and combat the nationwide opioid crisis. Like its predecessor, the federal Anti-Kickback Statute, EKRA established prohibitions against certain health care payment arrangements involving federal health care programs as well as instituted criminal sanctions for any statutory violation. What distinguishes EKRA, however, is that its authority applies to only certain entities including recovery homes, clinical treatment facilities, and laboratories.[1]

EKRA makes it illegal for any person, with respect to services covered by any health care benefit program (federal or private) to knowingly and willfully: (1) solicit or receive renumeration in return for referring a patient or patronage to a Subject Entity, or (2) pay or offer any renumeration to induce a referral to a Subject Entity or in exchange for an individual using the services of a Subject Entity.[2] A Subject Entity includes recovery homes, clinical treatment facilities, and laboratories. [3]

Penalties for a violation under EKRA can include a fine of not more than $200,000, imprisonment for not more than 10 years, or both, for each occurrence.[4]

For questions or more information about this topic, contact Jeana Singleton at jmsingleton@bmdllc.com or 330.253.2001, or feel free to contact any member of BMD’s Health Care Practice Group.

[1] Reesa N. Benkoff, Esq. & Dustin T. Wachler, Esq., EKRA: Enactment and Implications of the SUPPORT Act’s New All-Payor Federal Antikickback Law, American Bar Association (https://www.americanbar.org/groups/health_law/publications/aba_health_esource/2018-2019/march/ekra/).

[2] 18 U.S.C. § 220 (2018)

[3] Id.

[4] Id

 

 

Investment Training for the Second and Third Generations

Consider this scenario. Mom and Dad started the business from the ground up. Over the decades it has expanded into a money-making machine. They are able to sell the business and it results in a multimillion-dollar payday for their labors. The excess money has allowed Mom and Dad to invest with various financial advising firms, several fund management groups, and directly with new startups and joint ventures. Their experience has made them savvy investors, with a detailed understanding of how much to invest, when, and where. They cannot justify formation of a full family office with dedicated investors to manage the funds, but Mom and Dad have set up a trust fund for the children to allow these investments to continue to grow over the years. Eventually, Mom and Dad pass. Their children enjoy the fruits of their labors, and, by the time the grandchildren are adults, Mom and Dad's savvy investments are gone.

Provider Relief Funds – Continued Confusion Regarding Reporting Requirements and Lost Revenues

In Fall 2020, HHS issued multiple rounds of guidance and FAQs regarding the reporting requirements for the Provider Relief Funds, the most recently published notice being November 2, 2020 and December 11, 2020. Specifically, the reporting portal for the use of the funds in 2020 was scheduled to open on January 15, 2021. Although there was much speculation as to whether this would occur. And, as of the date of this article, the portal was not opened.

Ohio S.B. 310 Loosens Practice Barrier for Advanced Practice Providers

S.B. 310, signed by Ohio Governor DeWine and effective from December 29, 2020 until May 1, 2021, provides flexibility regarding the regulatorily mandated supervision and collaboration agreements for physician assistants, certified nurse-midwives, clinical nurse specialists and certified nurse practitioners working in a hospital or other health care facility. Originally drafted as a bill to distribute federal COVID funding to local subdivisions, the healthcare related provisions were added to help relieve some of the stresses hospitals and other healthcare facilities are facing during the COVID-19 pandemic.

HHS Issues Opinion Regarding Illegal Attempts by Drug Manufacturers to Deny 340B Discounts under Contract Pharmacy Arrangements

The federal 340B discount drug program is a safety net for many federally qualified health centers, disproportionate share hospitals, and other covered entities. This program allows these providers to obtain discount pricing on drugs which in turn allows the providers to better serve their patient populations and provide their patients with access to vital health care services. Over the years, the 340B program has undergone intense scrutiny, particularly by drug manufacturers who are required by federal law to provide the discounted pricing.

S.B. 263 Protects 340B Covered Entities from Predatory Practices in Ohio

Just before the end of calendar year 2020 and at the end of its two-year legislative session, the Ohio General Assembly passed Senate Bill 263, which prohibits insurance companies and pharmacy benefit managers (“PBMs”) from imposing on 340B Covered Entities discriminatory pricing and other contract terms. This is a win for safety net providers and the people they serve, as 340B savings are crucial to their ability to provide high quality, affordable programs and services to patients.