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What Awaits in the First Year of Medicare Drug Price Negotiations? CMS Issues Guidance and Solicits Comment on the 2026 Inflation Reduction Act Part D Negotiation Process

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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Nine Key Takeaways for Providers as Illinois Returns to Phase 4 of the “Restore Illinois” Plan

Time to Read: 3 minutes Practices: Health Care

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As of February 4, 2021, each of Illinois’s eleven regions has returned to Phase 4 of the “Restore Illinois” plan, with the City of Chicago returning to Phase 4 on January 31, 2021. Relatedly, on February 5, 2021, Governor Pritzker extended the COVID-19 Disaster Proclamation through March 6, 2021, and issued Executive Order 2021-04 (the “Order”) that reissues most prior Executive Orders through March 6, 2021 (certain of which are detailed below). We summarize below nine key takeaways for health care providers from the Order, Phase 4 guidance1 and other recent state actions.

Nine Key Takeaways for Providers

  • Extension of Licensure Reinstatement Executive Order.2 The Order extends the simplified medical licensure reinstatement requirements that enable providers with recently inactive licensure to return to work to further combat the pandemic. Additionally, the temporary practice permit program created by the Illinois Department of Financial and Professional Regulation (“IDFPR”) remains in effect, allowing out-of-state health care providers to receive temporary practice authorizations. All Temporary Practice Permits are currently set to expire on May 31, 2021. It remains to be seen whether IDFPR will extend the temporary practice permit program beyond May.
  • Extension of Telehealth Executive Order.3 To maintain expanded access to telehealth services during the COVID-19 public health emergency, providers may continue to use a host of technologies to deliver telehealth services, and will remain eligible for reimbursement from commercial payors for telehealth services.
  • Suspension of Laws Applicable to Hospitals.4 For the duration of the COVID-19 disaster proclamations, the following provisions continue to be suspended: (1) all requirements under the Hospital Report Card Act with the exception of the whistleblower protections and private right of action granted under the law; (2) most reporting deadlines under the Illinois Adverse Health Care Events Reporting Law of 2005;5 and (3) the Emergency Medical Services (EMS) Systems Act to the extent necessary to permit EMS personnel to transport patients to alternate care facilities (“ACF”).
  • Creation of ACFs. Hospitals licensed by the Illinois Department of Public Health (“IDPH”) or the State of Illinois can establish an ACF to treat COVID-19 patients or to treat non-COVID-19 patients to increase regional hospital capacity pursuant to emergency rules issued by IDPH.
  • Hospital Bed Capacity. Hospitals may still increase bed capacity and re-allocate bed designations between clinical services without prior authorization, so long as notice is provided to IDPH within 30 days after the temporary bed increase occurs and within 30 days after the facility’s normal bed capacity is resumed.
  • Provider Immunity Executive Order Not Extended. The Executive Order6 that granted immunity from civil liability to certain health care providers during the COVID-19 pandemic expired in June 2020. Accordingly, providers should be aware of increased potential for liability when providing services for COVID-19 patients.
  • CMS Waiver for Inpatient Services. To implement the recently created “Acute Hospital Care at Home” waiver from the Centers for Medicare and Medicaid (“CMS”), IDPH issued an emergency amendment to the Hospital Licensing Requirements on January 8, 2021, set to last 150 days. Qualifying hospitals will be permitted to provide limited inpatient services directly in a patient’s home to alleviate strain on hospital resources and capacity while protecting those with comorbidities from contracting COVID-19.
  • Non-Discrimination in Administration of COVID-19 Vaccine. On January 6, 2021, IDPH issued guidance concerning steps that the health care community should consider to ensure that marginalized communities have access to medical treatment during the COVID-19 public health emergency.7
  • Dentists May Administer COVID-19 Vaccines. On January 29, 2021, IDFPR issued a proclamation expanding the scope of practice for Illinois licensed dentists to include administration of COVID-19 vaccines to individuals age sixteen and older. Such temporary changes expire upon the termination of the COVID-19 Disaster Proclamation. To be eligible, dentists must meet certain requirements, such as completion of an approved practical training program of at least four hours concerning vaccine administration, possessing a current basic certificate in CPR, and complying with vaccine recordkeeping and reporting requirements.8 IDPH’s guidance concerning the provision of routine oral and dental care remains in effect.
  1. For guidance for businesses operating in the state of Illinois in Phase 4, including industry-specific guidance, please see the Illinois Department of Commerce & Economic Opportunity Phase 4 guidance. The City of Chicago has also released industry-specific guidance for Chicago businesses operating during Phase 4, including updated capacity guidance for industries and activities in the City of Chicago.
  2. Executive Order 2020-09, as modified by Executive Order 2020-52.
  3. Id. For additional information, please see our prior alert.
  4. Executive Order 2020-26.
  5. It is ambiguous under the Hospital Capacity Order and emergency rule when the clock begins to run on submitting un-submitted adverse event reports. Adverse event reports are ordinarily due 30 days after discovery of the event, and root cause analyses are due 90 days after submission of a report.
  6. Executive Order 2020-37.
  7. Relatedly, on February 11, 2021, Chicago Mayor Lori Lightfoot and Cook County Board President Toni Preckwinkle jointly announced that the City of Chicago and Cook County will not be expanding eligibility for COVID-19 vaccines during Phase 1B to individuals with certain underlying medical conditions. This follows Governor Pritzker’s announcement on February 10, 2021 that Illinois residents outside of Cook County who are younger than 65 years old and have preexisting health conditions will be eligible to receive the COVID-19 vaccine beginning on February 25, 2021.
  8. Alternatively, an Illinois licensed dentist may volunteer, as part of a mass vaccination effort, to administer COVID-19 vaccines to individuals age sixteen or older under the supervision and coordination of a medical facility or local health mass vaccination plan under a Just in Time Training Model so long as certain requirements listed in the proclamation are met.
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