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.
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 23-204, “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.
Connecticut Places Checks on PBM Contracts in Support of 340B Covered Entities
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
Addressing COVID-Related Staffing Shortages: Strategies To Recruit And Retain Employees
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
OIG Compliance Updates
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.
HHS Proposes Rule to Align Part 2 Records and HIPAA
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.
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340B Update: District Court Rejects 2022 Payment Methodology for 340B Hospitals Following Supreme Court Win
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.
The DOJ Continues to Prosecute Providers for Fraudulent Telemarketing and Telehealth
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.
Supreme Court Decides in Favor of 340B Hospitals Regarding Medicare Reimbursement Methodology
On June 15, 2022, the U.S. Supreme Court unanimously ruled in favor of “340B” hospitals in a notable statutory interpretation case concerning how the federal Medicare program reimburses hospitals for prescription drugs. The case, which was brought by the American Hospital Association, arises from reimbursement reductions imposed by the Department of Health and Human Services (HHS) in 2018 and 2019 on hospitals participating in the 340B program (which the Court noted are hospitals that “generally serve low-income or rural communities”). In those years, HHS sought to impose reductions in reimbursement due to favorable pricing available to 340B hospitals under that program. The hospitals challenged those reductions based on the process HHS followed when setting the reimbursement rates, claiming that HHS’s failure to conduct a survey of hospitals’ average acquisition costs for the drugs prevented HHS from varying reimbursement rates for this distinct group. Therefore, according to the hospitals, HHS was required to pay them based on the average sales price charged by manufacturers for the drugs.
Connecticut Expands Advanced Practice Providers’ Scope of Practice to Include Certain Forms of Abortion
Connecticut Governor Ned Lamont recently signed legislation to expand the scope of practice of advanced practice registered nurses (APRNs), nurse-midwives, and physician assistants (PAs) to perform certain forms of abortion.