As a manufacturer of an FDA-registered Class II or Class III medical device, the FDA may conduct an inspection of your organization at any time. In other words, your company is subject to random, unscheduled inspections. Reasons for an inspection may include a routinely scheduled investigation, an accumulation of incident reports or consumer complaints, or […]

California’s 2022 – 2023 budget allocates slightly more than $100 million to establish the CalRx Biosimilar Initiative – where California will develop, in partnership with a contract manufacturer, biosimilar insulin products and sell them at very reasonable prices. California intends to be selling insulin products, at a massive scale, within a few short years. 37 […]

  CHANGES COMING TO THE INSULIN MARKET! Branded as “$30 Insulin by CalRx,” Governor Newsom announced on March 18, 2023, that California has entered into a $50 million, ten-year contract with Civica Rx for it to manufacture and distribute generic insulin in California. While Civica still needs to obtain FDA approval for its proposed insulin […]

  The California legislature is debating proposed legislation (Assembly Bill 3129) that would significantly increase the California Attorney General’s powers to review and, in some circumstances, prevent private equity groups and hedge funds from investing in California hospitals, physician practices and the like. In order to become law, AB 3129 must secure approval in both […]

CMS recently adopted new rules that regulate the amount that Medicare Advantage and MAPD plans can pay to third parties for providing administrative services. These services include providing Health Benefit Assessment support and call center services, developing software to permit agents to compare plan benefits, helping beneficiaries fill out forms and monitoring agent licensure and […]

Elizabeth Mann, Managing Partner California’s legislature passed Assembly Bill 3129 on August 31, 2024. Governor Newsom has 30 days to veto or sign the new law.  If signed, the statute becomes effective on January 1, 2025.This law would significantly increase the California Attorney General’s powers to review and, in some circumstances, prevent private equity groups […]

Elizabeth Mann, Managing Partner California’s legislature passed a law that required PE firms and hedge funds to obtain prior written consent from the AG’s office before closing a transaction that involved a material investment in, or a change of control of, a California healthcare facility or provider group. Governor Newsom vetoed this bill.  His rationale […]

Elizabeth Mann, Managing Partner California’s Office of Health Care Affordability (OHCA) has jurisdiction to review proposed material change transactions involving healthcare entities for cost and market impact. Current law does not capture private equity or hedge fund activity, nor does the statute regulate management service organizations. California’s legislature passed AB 1415, which expands OHCA’s authority […]

Elizabeth Mann, Managing Partner SB 351 adds a new section to the California Health & Safety Code entitled “Private Equity or Hedge Fund Ownership of Health Care Practices.” This statute pointedly applies California’s Corporate Practice of Medicine/Dentistry rules to PE/hedge fund healthcare transactions. The statute exempts lenders, i.e., “banks and credit unions, commercial real estate […]