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.
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.
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.
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 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.
As previously addressed on this blog, Connecticut Governor Ned Lamont recently signed into law the state’s fiscal year 2023 budget (HB5506) (Act). Among other things, the Act prohibits homemaker-companion or home health agencies from contractually preventing their clients from hiring agency employees. The Act deems such “no-hire” clauses as against public policy.
A federal court in Delaware recently determined that the Health Resources and Services Administration (HRSA) – the federal agency responsible for administering the 340B drug pricing program – did not comply with the Administrative Procedure Act (APA) when it issued a May 17, 2021 letter to AstraZeneca to enforce the use of contract pharmacies under the 340B statute (“Enforcement Letter”). In its decision, AstraZeneca v. Becerra, No. 1:21-cv-00027 (D. Del.) (Feb. 16, 2022), the federal district court for the District of Delaware vacated and set aside HRSA’s Enforcement Letter, and remanded the matter to HRSA for further consideration. The Court stated that it will further solicit the parties’ views on the impact of the Court’s conclusions to assess if and how the case should proceed, in terms of affording relief under AstraZeneca’s complaint.
Continue Reading Delaware District Court Determines that HRSA Enforcement Letter Targeting 340B Program Restrictions Violates the APA
On November 12, 2021, the Centers for Medicare & Medicaid Services (CMS) issued finalized guidance (“Guidance”) clarifying that hospitals can share space, services, or personnel with another hospital or health care provider so long as they demonstrate independent compliance with the Medicare Conditions of Participation (CoPs). This Guidance, which finalizes the prior draft guidance issued on May 3, 2019, explains how CMS and state agency surveyors will evaluate a hospital’s space sharing or contracted staff arrangements when assessing the hospital’s compliance with the Medicare CoPs. The Guidance took effect immediately upon publication on November 12, 2021.
As relayed by CMS, hospitals have increasingly co-located with other hospitals or other healthcare entities as they seek efficiencies and develop different delivery systems of care. Co-location occurs when two Medicare certified hospitals or a Medicare certified hospital and another healthcare entity are located on the same campus or in the same building and share space, staff, or services.
Continue Reading CMS Finalizes Guidance on Hospital Co-Location