Antitrust

The Colorado General Assembly is back in session and has introduced legislation (SB26-041) that, if enacted, would create new notification requirements and antitrust review processes for healthcare transactions. While Colorado already requires state-level notification of transactions that trigger federal notifications under the Hart-Scott-Rodino Act and notification of certain hospital transactions under the Hospital Transfer Act (“HTA”) of 2023, the proposed bill would create new notification requirements for a broader set of healthcare transactions, and would authorize the Colorado attorney general (“COAG”) to block or delay closing of transactions. The proposed bill also expands the scope of hospital transactions that must be reported under the HTA.

Consistent with the Biden Administration’s whole-of-government approach to address perceived consolidation in a variety of industries, including in the healthcare industry, the Federal Trade Commission (FTC) and U.S. Department of Justice (DOJ) Antitrust Division (collectively, the Agencies) are continuing to make good on their promise to increase scrutiny of mergers and acquisitions through newly proposed HSR rules and revised merger guidelines.

Because the healthcare industry is heavily regulated and complex, most healthcare deals involve a sign-then-close structure; that is, they have a period of time between signing the agreement and the closing date. This built-in period after signing the purchase agreement gives the parties time to obtain necessary approvals or perform necessary pre-closing covenants.

As with any transaction, a healthcare deal typically starts with a Letter of Intent (“LOI”) or Term Sheet to outline the base agreements on the business deal. The LOI or Term Sheet should include not only the purchase price (or range), purchase price adjustments, payment terms, closing conditions, confidentiality, exclusivity, and other common items, but also the transaction structure – for example, asset sale, stock/membership interest sale, merger, joint venture, affiliation, etc.

The U.S. Court of Appeals for the 9th Circuit affirmed a lower court’s findings Feb. 10, 2015, that the acquisition by St. Luke’s Health System (“St. Luke’s”) of Saltzer Medical Group (“Saltzer”), a physician group consisting mostly of primary care physicians, violated Section 7 of the Clayton Act. This is the first case in which the Federal Trade Commission (“FTC”) litigated through trial a challenge to a physician acquisition.

Due diligence is often perceived as a mundane part of the mergers & acquisitions (M&A) process, but its importance in healthcare transactions is critical. Due diligence is one of the first steps of any transaction and involves a buyer undertaking an in-depth examination of the target to evaluate the business and uncover potential issues or liabilities. In the healthcare industry, diligence is especially important considering the heavy regulation of the industry, the unique areas of risk, and the significant liabilities that could be imposed upon a buyer if issues and liabilities are not identified before the transaction closes.

The American Health Lawyers Association (AHLA) Fundamentals of Health Law conference, Nov. 12-14 in Chicago, featured Husch Blackwell Partner Cori Turner as a speaker and key member of the planning committee.

The conference primarily focused on ensuring attendees gained an understanding of laws and regulations for the health law industry, including Stark and Anti-Kickback, False Claims Act, antitrust, tax and HIPPA regulations. Its goals also included increasing knowledge of the legal challenges faced by hospitals, physicians, long-term care providers and managed care organizations, as well as learning about the impact of the health reform law on the healthcare industry.

On April 16, in a win for Purdue Pharma, the maker of OxyContin, the FDA issued a decision approving updated labeling for Purdue’s reformulated, abuse-resistant OxyContin tablets. The decision places drug makers on notice that the FDA will not accept or approve any abbreviated new drug applications (generics) that rely upon the agency’s December 1995 approval of Purdue’s original OxyContin formulation.

The FDA’s decision was issued just as Purdue was set to lose its patent on the original formulation of OxyContin. Loss of this patent would have opened the opioid-painkiller market to competition from generic drug makers. But now, going forward, new applications for generic “copycat” forms of the drug must meet Purdue’s approved, abuse-resistant standard, without infringing upon Purdue’s patent for reformulated OxyContin, which lasts until 2025.

Concern over abuse of the well-known painkiller was central to the FDA’s decision. The agency explained, in a press release accompanying its decision: Purdue’s “labeling indicates that the [reformulated] product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting).” The press release further stated that: The original formulation of OxyContin “was abused, often following manipulation intended to defeat its extended-release properties. Such manipulation causes the drug to be released more rapidly, which increases the risk of serious adverse events, including overdose and death.”

According to the New York Times, the FDA’s decision was pushed by some state attorneys general, as well as pain treatment experts, who argued that the release of generic versions of OxyContin would feed street demand for the narcotic. Critics, however, have argued that the decision will result in higher prices for OxyContin, as the reformulated drug will not face generic competition.

The FTC recently provided yet another warning to healthcare organizations that they must take the time to analyze potential antitrust implications when considering an acquisition or consolidation.  On August 6, the FTC  and Nevada Attorney General announced the filing of a lawsuit and proposed consent decrees settling litigation filed against Renown Health, the largest hospital provider in…