In 2015, Assistant Attorney General Leslie Caldwell spoke publicly about the importance for every healthcare provider to not only have a compliance program on its shelf, but also being sure that the compliance program is “tailored to the unique needs, risks and structure of each business or industry.” Assistant Attorney General Caldwell explained, “the adequacy of a compliance program is a factor when [the DOJ] decide[s] how and whether to prosecute a company. The lack or insufficiency of a compliance program can have real consequences for a company when a violation of law is discovered.”
How serious is the federal government that corporate compliance is necessary for healthcare providers?
In late 2015, the Department of Justice (DOJ) hired the agency’s first Compliance Counsel. Then, in early 2017, the DOJ published “common questions” that US Attorneys should ask as part of a criminal investigation when the DOJ evaluates a company’s compliance program. The “common questions” published by the DOJ describe specific factors that prosecutors should consider in conducting an investigation of a corporate entity, determining whether to bring charges, and negotiating plea or other agreements. These factors include “the existence and effectiveness of the corporation’s pre-existing compliance program” and the corporation’s remedial efforts “to implement an effective corporate compliance program or to improve an existing one.”
Telehealth law Florida is constantly evolving The latest example is found with Florida’s Department of Children and Families (DCF) recent proposed rule change which now includes a definition of Telehealth as a delivery system in substance abuse. Telehealth can be used in treatment or prevention services through electronic communications from one site to another. However, it does not include delivery of services using only the audio on a telephone, or e-mails, text messages, fax transmissions, US mail or other parcel service. Proposed Rule 65D-30.0031 (83) Definitions.
Telehealth services can be used in intensive outpatient, day or night treatment, day or night treatment with community housing, outpatient, interventions, aftercare, and prevention. If a substance abuse provider plans on including telehealth services it must submit to DCF detailed procedures outlining which services it intends to provide. The provider will be responsible for the quality of the equipment and technology used in the telehealth service. Proposed Rule 65D-30.004 (20) Common Licensing Standards.
The U.S. Food and Drug Administration (FDA) has issued new guidance for regenerative medicine manufacturers and healthcare providers. At the core of the guidance are two central interpretations: 1) the FDA’s current interpretation of the minimal manipulation and homologous use criteria set forth in 21 CFR Part 1271; and 2) the FDA’s current view on the same surgical procedure exception under 21 CFR 1271.15(b). Additionally, the FDA issued a notice to all interested stakeholders that the FDA intends to initiate increased discretionary enforcement over the next 36 months for human cell and tissue-based products. Given these developments, healthcare companies and providers impacted by this guidance are strongly encouraged to ensure compliance with the FDA’s new interpretations.
I had a law school professor who repeatedly referred to his class as “Doom at Noon.” The topic was dry, the cases were boring and, if not for the professor himself, the class would have been unbearable. I think of that, all these years later, every time I have to counsel a client on a topic that makes his or her eyes glaze over, like healthcare compliance.
Compliance means that you’re operating within the bounds of law. Sure, it sounds boring, but it’s a giant undertaking for any business, and especially for one so regulated as healthcare. Over the last three decades, the Department of Health and Human Services’ Office of the Inspector General has urged the private healthcare community in to take steps to combat fraudulent conduct and prevent the submission of erroneous claims.
Health law is the federal, state, and local law, rules, regulations and other jurisprudence among providers, payers and vendors to the healthcare industry and its patient and delivery of health care services; all with an emphasis on operations, regulatory and transactional legal issues.