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On March 15, 2023, the Centers for Medicare & Medicaid Services (“CMS”) issued an initial guidance memorandum (“Memorandum”) describing how it proposes to implement the Inflation Reduction Act Medicare Drug Price Negotiation Program (“Negotiation Program”) for the Initial Price Applicability Year of 2026 (the “Initial Year”). In the Memorandum, CMS provides further guidance regarding (i) how it intends to select the Medicare Part D drugs and biologics for which it will negotiate a maximum fair price (“MFP”) for the Initial Year (the “Selected Drugs”), (ii) the data and evidence that manufacturers will be required to submit that will inform CMS’s initial price proposals, (iii) the structure of the negotiation process, and (iv) implementation and enforcement of the MFP.

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Five-Phase “Restore Illinois” Plan Announced to Re-Open State

Time to Read: 2 minutes Practices: Health Care

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On May 5, 2020, shortly after extending the stay-at-home order through the end of May, Governor J.B. Pritzker announced the “Restore Illinois” plan (the “Plan”) that details the governor’s phased approach to safely re-open Illinois. The Plan outlines a five-phase approach for restoring operations for businesses, educational institutions, and recreational activities. Progression between the phases occurs only when certain benchmarks are achieved. While the final phase contemplates the existence of a vaccine, effective and widely available treatment, or the elimination of new cases over a sustained period of time, the interim phases offer a gradual return to normalcy as salons, gyms, movie theaters, and bars and restaurants are allowed to open with appropriate precautions.

Importantly, the Plan provides for four general regions of Illinois—Southern, Central, Northeast, and North-Central—that can progress independently through the phases or be demoted based upon each region meeting appropriate benchmarks. We anticipate that this is a direct response to growing pressure from lawmakers and the public to re-open the areas of the state outside of Cook County more expeditiously in light of the fact that the Northeast Illinois region accounts for most of the COVID-19 cases in the state.

According to the Governor, each region of Illinois is in Phase 2, given that the rate of COVID-19 infection is stabilizing. Phase 2’s business and social distancing requirements mirror the requirements outlined in the Governor’s May stay-at-home orders. To progress to Phase 3, a region must meet three criteria: (a) COVID-19 positivity and regional hospital surge capacity measurements must be satisfied;1 (b) COVID-19 testing must be available for all patients, health care workers, first responders, people with underlying conditions, and individuals in congregate living facilities; and (c) contact tracing of individuals who test positive for COVID-19 must be available within 24 hours of diagnosis (which will likely involve, within 24 hours of the individual testing positive for COVID-19, attempting to contact all people that the positive individual had contact with for the previous two weeks). Key to the criteria that must be satisfied to move to Phase 3 is that the region have not experienced an overall increase in hospital admissions for COVID-19-like illnesses for 28 days. In light of this requirement, Governor Pritzker confirmed during his May 5, 2020 press conference (the “Press Conference”) that the earliest a region can move to Phase 3 is May 29, 2020 (28 days after each region entered Phase 2).

Given the regional variances in current COVID-19 cases, Southern, Central, and North-Central Illinois may progress to Phase 3 more quickly than Northeast Illinois based on current data made available by the Illinois Department of Public Health (the “IDPH”). As of May 5, 2020, IDPH published regional hospital resource availability, and the current data further support the notion that Southern, Central, and North-Central Illinois have significant bed availability and a COVID-19 test positivity rate under 15 percent. Separately, we note that while Governor Pritzker announced Illinois’s plan to start a contact tracing program at the Press Conference, the details have not yet been worked through.

We anticipate that the Governor’s office and state agencies will release further guidance throughout the month of May on how to implement each phase of the Plan. Please feel free to contact us with any questions concerning the Plan. We also welcome you to visit the Ropes & Gray Coronavirus Resource Center for more information and updates concerning COVID-19 developments.

  1. The three criteria are that the region (1) is at or under a 20 percent positivity rate and increasing no more than 10 percentage points over a 14-day period, (2) has no overall increase in hospital admissions for COVID-19-like illness for 28 days, and (3) has available surge capacity of at least 14 percent of ICU beds, medical and surgical beds, and ventilators.
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