The Competition and Markets Authority (CMA), the competition regulator in the UK, has undertaken a number of investigations into suspected anticompetitive practices in the pharma sector in recent years. Most recently, the CMA announced on 3 October 2019 that it has issued a Statement of Objections to pharmaceutical companies Aspen, Amilco and Tiofarma. The CMA’s … Continue Reading
A recent Centers for Medicare & Medicaid Services (CMS) final rule reduces some Medicare reimbursements to hospitals in 2018, paying 28 percent less for certain “specified covered outpatient drugs” (SCODs) purchased at a discount through the 340B Drug Pricing Program (340B). Although hospitals recently lost a challenge to the lower CMS rates in American Hospital Association … Continue Reading
According to press reports, CVS/Caremark’s proposed $66 billion acquisition of Aetna is at the Department of Justice Antitrust Division (DOJ) for antitrust review, as opposed to the Federal Trade Commission (FTC). Under our bifurcated system of antitrust review, both agencies theoretically could have made a claim for the deal. The FTC historically has reviewed transactions … Continue Reading
As discussed previously here, here, and here, antitrust matters are a key consideration in the design of the Shared Savings Program and ACO development. For example, antitrust review of prospective ACOs by the FTC and/or DOJ is a critical aspect of the ACO application process. Despite the release of the joint statement, there is evidence … Continue Reading
On Friday, April 8, Peter Pavarini and I co-presented a webinar overviewing the ACO regulations from a legal perspective. We were part of a three-firm “task force” that came together to analyze the rules and provide guidance to our clients and friends. In addition to Squire Sanders, Paul Lee and others from Strategic Health Care and … Continue Reading
In commentary to the proposed regulations, CMS has committed to coordinate with other Federal agencies on various issues that relate to the Shared Savings Program. This includes coordination with the FTC and DOJ (the “Antitrust Agencies”) with respect to antitrust issues. This coordination is shown through CMS’s intention to incorporate the FTC/DOJ Proposed Statement on … Continue Reading
The Federal Trade Commission and Department of Justice (the “Agencies”) recently released Proposed Statement of Antitrust Enforcement Policy Regarding ACOs, which contains several points of interest: Rule of Reason Treatment. The Agencies will provide rule of reason treatment to an ACO if, in the commercial market, the ACO uses the same governance and leadership structure and … Continue Reading
Several important antitrust points of interest in the hot-off-the-presses ACO regulations issued today: The Department of Justice and the Federal Trade Commission have a new challenge – figuring rules of the road as joint administrators of the ACO antitrust review process, acting through a newly formed joint working committee. The agencies will either have to … Continue Reading
