On November 15, 2024, the California Board of Pharmacy issued a public notice of its intent to modify Cal. Code Regs. tit. 16 § 1708.2, which governs the discontinuation of pharmacy businesses in California. The regulation currently states:
“Any permit holder shall contact the board prior to transferring or selling any dangerous drugs, devices or
Keypoint: With the increased frequency and severity of cyberattacks against healthcare systems, state and federal agencies strive to improve cybersecurity controls with varied success.
In November 2023, New York Governor Kathy Hochul announced proposed regulations that would be the first state regulations for hospitals in New York. The governor described the proposed regulation as a “nation-leading blueprint” that would complement the federal Health Insurance Portability and Accountability Act (HIPAA) Security Rule enforced by the U.S. Department of Health and Human Services (HHS).
Engaging in management and investor conversations about maintaining and growing a business is critical, no matter the industry. Whether you’re discussing normal business sustainability, organic growth, or contemplating a sale, these discussions become more complex when practicing physicians are the business’s revenue generators. These conversations must be handled carefully to comply with the spirit and letter of healthcare’s strict fraud and abuse laws. To ensure these discussions are both productive and compliant, it’s essential to navigate these complex regulations effectively.
On July 3, 2024, Judge Louis Guirola, Jr. of the federal district court in Mississippi issued a nationwide preliminary injunction prohibiting the U.S. Department of Health and Human Services (HHS) from “enforcing, relying on, implementing, or otherwise acting on” the gender identity provisions of a HHS Final Rule that purported to implement Section 1557 of the Patient Protection and Affordable Care Act (ACA) and was set to go into effect on July 5, 2024. The injunction was sought by a plaintiff group comprised of fifteen individual states that alleged the Final Rule violates existing statutory and constitutional law. The breadth of the injunction includes 42 C.F.R. §§ 438.3, 438.206, 440.262, 460.98, and 460.112; 45 C.F.R. §§ 92.5, 92.6, 92.7, 92.8, 92.9, 92.10, 92.101, 92.206-211, 92.301, 92.303, and 92.304 “in so far as these regulations are intended to extend discrimination on the basis of sex to include discrimination on the basis of gender identity.” While the injunction halts the gender identity provisions of the 2024 Final Rule, the remaining provisions of the 2024 Final Rule remain in effect.
Exiting a business, whether you are a serial entrepreneur looking to move on to the next project or a healthcare provider like a physician or therapist who has nurtured your practice for decades, can be difficult. After all, corporate transactions are complex affairs that often hang on small details. That’s to say nothing of the emotions that business owners sometimes experience when stepping away from an enterprise into which they have poured their sweat and passion.
For those in the healthcare industry, the complexities only get tougher to tackle. As one of the most heavily regulated industries, healthcare embodies a level of regulatory risk—from merely annoying to existential—that most businesses don’t have to contemplate, making succession and exit plans hard to develop and harder still to execute.
This post is the first in a series dedicated to Colorado’s Medicaid finance and payment systems, challenges faced by those programs, and opportunities for expansion.
The Colorado Healthcare Affordability and Sustainability Enterprise (CHASE) oversees Colorado’s hospital provider tax and the use of those taxes to support Medicaid supplemental payments. CHASE uses the largest portion of those taxes to generate payments targeting the cost shortfalls from treating Medicaid and uninsured patients. Broadly speaking, federal regulations (see 42 C.F.R. §§ 447.272, 447.321) allow each class of institutional providers to be paid for Medicaid services (on a fee-for-service basis) to a level that approximates what could have been paid under Medicare payment principles. This is known as the Upper Payment Limit (UPL). For the past several years, CHASE has limited these payments to less than the full amount permitted by federal law out of concerns about potential overpayments and statewide recoupment risks. The Colorado Hospital Association (CHA) is currently advocating for CHASE to increase payments to 100% of the UPL—i.e. “the full UPL.”
On April 29, 2024, the Food and Drug Administration (FDA) announced a Final Rule amending regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act including when the manufacturer of the IVD is a laboratory. Under the new rule, the FDA will phase out its laboratory developed test (LDT) enforcement discretion policy over a four-year period. The phaseout policy “applies to IVDs that are manufactured and offered as LDTs by laboratories that are certified under CLIA[1] and that meet the regulatory requirements under CLIA to perform high complexity testing, and used within such laboratories, even if those IVDs do not fall within FDA’s traditional understanding of an LDT because they are not designed, manufactured, and used within a single laboratory.”
Every year, I look forward to the SXSW Interactive Health & MedTech Track, which showcases and explores the future of healthcare technology being created by innovators, entrepreneurs, and tech enthusiasts. This year is no different!
The recent, rapid advancement of the development of artificial intelligence and machine learning (AI) has revolutionized various industries. It is unsurprising then, that at this year’s South by Southwest Conference (SXSW), there are more AI related panels than any other subject — by far.
Husch Blackwell’s False Claims Act team previously covered the results of a rare False Claims Act (FCA) trial in which a federal jury found that a surgical product distributor was liable for paying kickbacks to physicians. The federal judge overseeing that trial initially entered judgment against the distributor defendants for $487 million after trebling the government’s actual damages and then adding penalties for each kickback-tainted claim.
On February 8, 2024, however, that same federal judge amended the judgment over concerns that the statutory penalties were unconstitutionally excessive. This article highlights the issue and explains what those accused of violating the FCA can learn from this decision.