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Yelena Greenberg advises hospitals, academic medical centers, nursing homes, physician groups, and university health centers and clinical programs on a broad range of health law issues. Lena is a member of the firm’s Health Law Group. Read her full rc.com bio here.

Below is an excerpt of an article published in American Health Law Association’s Regulation, Accreditation, and Payment Practice Group on March 21, 2024.

The 340B program, as established under Section 340B to the Public Health Service Act (PHSA), Pub. L. No. 78-410, 58 Stat. 682 (1944) (“340B Statute”),[1] has experienced significant legal challenges

On February 8, 2024, the U.S. Department of Health and Human Services (HHS) issued a final rule (Final Rule) updating federal “Part 2” regulations to more closely align the requirements applicable to substance use disorder (SUD) treatment records with the HIPAA privacy rule, and to make certain other changes. The regulations at 42

On September 27, 2023, the Health Resources and Services Administration (HRSA) issued a Notice in the Federal Register applicable to all 340B Program hospitals that formally ends a COVID-era waiver of the long-standing HRSA requirement that off-site, outpatient facilities be (1) listed as reimbursable on the hospital’s Medicare Cost Report (MCR) prior to participating in the 340B Program; and (2) registered and listed in the Office of Pharmacy Affairs Information System (OPAIS) prior to participating in the 340B Program.Continue Reading HRSA Confirms End of COVID Waiver of Advance Registration Requirement for Provider-Based Clinics

On June 27, 2023, Connecticut Governor Ned Lamont signed into law Public Act 23-204, “An Act Concerning the State Budget for the Biennium Ending June 30, 2025, and Making Appropriations Therefor, and Provisions Related to Revenue and Other Items Implementing the State Budget” (the Act). Among other things, the Act includes provisions addressing hospitals’ obligations with regards to staffing, nurse overtime, and nurse scope of practice.Continue Reading Connecticut Expands Nurse Protections Relating to Hospital Nurse Staffing Plans, Scope of Practice, and Overtime

On June 27, 2023, Connecticut Governor Ned Lamont signed into law Public Act 23-171“An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs” (Act), which includes changes to the state’s implementation of the federal 340B Drug Pricing Program. The Act: (a) requires the Commissioner of Social Services to convene a working group to evaluate the myriad issues affecting the 340B Program and opportunities for the state to support the 340B Program; and (b) prevents pharmacy benefit managers (PBMs) from incorporating certain contract provisions in agreements with qualifying Covered Entities under the 340B Program that lower reimbursement to such Covered Entities, among other restrictions.Continue Reading Connecticut Places Checks on PBM Contracts in Support of 340B Covered Entities

Below is an excerpt of an article co-authored with Robinson+Cole Labor and Employment Group lawyer Sapna Jain and published in the April/May 2023 issue of the Massachusetts Bar Association’s (MBA) eJournal. Yelena and Sapna will also be presenting an informative MBA webinar on the same topic on May 10, 2023.

Health care staffing continues

The Office of Inspector General (OIG) recently issued two notable compliance updates, of which health care organizations should take note as the COVID-19 public health emergency ends and regulatory compliance activities ramp up.Continue Reading OIG Compliance Updates

On November 28, 2022, the Department of Health and Human Services (HHS) issued a proposed rule to modify the confidentiality protections of Substance Use Disorder (SUD) patient treatment records under 42 CFR Part 2 (Part 2) to implement statutory amendments passed under Section 3221 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act (42 U.S.C. 290dd-2). Comments are being accepted for 60 days from the date of publication.Continue Reading HHS Proposes Rule to Align Part 2 Records and HIPAA

We follow up on our previous blog post concerning the U.S. Supreme Court’s unanimous ruling in favor of 340B hospitals. The Supreme Court previously held that “absent a survey of hospitals’ acquisition costs, HHS may not vary the reimbursement rates for 340B hospitals” and therefore, that HHS exceeded its statutory authority by varying the 2018 and 2019 rates for 340B hospitals without first conducting such survey.Continue Reading 340B Update: District Court Rejects 2022 Payment Methodology for 340B Hospitals Following Supreme Court Win

A physician in Washington state pled guilty on September 28, 2022, to a criminal charge of conspiring to accept kickbacks related to fraudulent genetic testing. According to the Department of Justice (DOJ), the physician ordered certain genetic testing for Medicare beneficiaries that he was not treating and with whom a physician-patient relationship was not established as part of the scheme. According to the plea agreement accepted by the physician, the physician would be connected by telemarketers to the beneficiaries for a few minutes, the physician would order the diagnostic test, the labs would then bill for the test, and another company billed Medicare for the purported telemedicine visit. The physician received almost $168,000 in kickbacks for ordering the medically-unnecessary testing and other services, which resulted in over $18 million being paid by Medicare.Continue Reading The DOJ Continues to Prosecute Providers for Fraudulent Telemarketing and Telehealth