U.S. COVID Public Health Emergency to End on May 11; World Health Organization Takes Similar Step
After more than three years, the U.S. government will end the COVID Public Health Emergency (PHE) on May 11. Last week, the World Health Organization took a similar step after its COVID emergency advisory panel declared that the disease no longer met the criteria as a Public Health Emergency of International Concern. “The emergency phase of this global crisis that we’ve all been facing for three-and-a-half years is over, but COVID is here to stay,” said Maria Van Kerkhove, WHO’s COVID technical lead. The U.S. Department of Health & Human Services (HHS) announced earlier this year that the national PHE would end in May. Since that time, the department has provided guidance on a plethora of topics related to the PHE expiration. On May 5, CMS updated its PHE Expiration FAQ Document that covers issues such topics as COVID vaccines for people with Medicare (they’re still covered without patient cost sharing), access to COVID anti-viral therapies (things won’t change), waiver of the Medicare three-day qualifying hospital stay before a skilled nursing facility (SNF) stay (this waiver will end on 5/11) and broad expansion of telehealth coverage (it will continue in most cases, but with some restrictions—see article below). The 30-question FAQ document covers issues facing Medicare, Medicaid and private insurance consumers.
Bipartisan Efforts to Ensure Permanent Expansion of Telehealth Services Continue in Congress
While legislation passed in late 2022 ensures the general expansion of covered telehealth services through 2024, members in both parties continue to lay the groundwork for permanent expansion. In the House, Reps. Troy Balderson (R-OH) and Susie Lee (D-NV) are teaming up on H.R. 1110, the Knowing the Efficiency and Efficacy of Permanent Telehealth Options Act (KEEP). The bill requires HHS, the Medicare Payment Advisory Committee (MedPAC) and the Medicaid and Children’s Health Payment and Access Committee (MACPAC) to conduct reports and issue recommendations on parameters for permanent telehealth expansion, building off of what was learned during the COVID-19 pandemic. Balderson said the data would be critical to legislating permanent expansion of telehealth before the end of 2024. The legislation is supported by a wide range of health care groups, including the American Hospital Association. In addition to legislation, stakeholders are pressing CMS to continue some practices that were allowed during the pandemic but will not be allowed after the PHE expires May 11. Johns Hopkins is asking the agency to extend flexibility allowing virtual supervision of residents in metro and non-rural areas and remove requirements that both the physician and the resident have to both see the patient concurrently (with both the resident and supervision physician in the same physical location) in order for the telehealth visit to be covered. Both Johns Hopkins and the Association of American Medical Colleges (AAMC) are asking CMS for additional guidance to clarify this post-PHE requirements.
Inflation Reduction Act (IRA): Former FDA Commissioner Calls for Utilizing “Non-Political” Value-Based Pricing Resources to Determine Drug Prices
Former FDA Commissioner Scott Gottlieb told participants at the Pharmaceutical Care Management Association (PCMA) Policy Forum in late April that given the political nature of drug pricing, the government should rely on outside value-based recommendations developed by outside experts to determine the price the government will pay, not internal CMS and HHS resources. Gottlieb specifically said the controversial Institute for Clinical and Economic Review (ICER) should be considered. This September, HHS will announce the list of drugs selected for negotiation. Final prices will be released in September 2024 following the negotiation process. These prices will go into effect in January 2026. Gottlieb said that President Biden sees drug pricing as a winning campaign issue and given the timing of the drug price announcements (two months before the 2024 presidential election), it would be wise for the federal government to partner with outside value-based resources to make the process more focused on clinical data and economic value, rather than politics. Gottlieb was sharply critical of CMS’ initial guidance on the Medicare drug price negotiation program, including the requirement that manufacturers destroy records relating to the negotiation after the process has concluded. “They very clearly don’t want to be bound by any precedent,” Gottlieb said.
Minnesota and Nevada Legislatures Advance Prescription Drug Pricing Bills
Long-awaited legislation to create a Prescription Drug Affordability Board (PDAB) in Minnesota has been included in omnibus budget bills that are likely to receive final approval and be signed by Governor Tim Walz (D). In a last-minute attempt to sway a handful of Democratic members (Democrats control the legislature by slim margins in Minnesota), newspaper ads and billboards are calling on specific legislators to oppose the proposal, calling it a gift to pharmacy benefit managers and big insurance companies. In Nevada, one chamber has passed AB 250, dubbed the Affordable Medicine Act, which applies price caps set by Medicare in the forthcoming Inflation Reduction Act (IRA) implementation to all Nevadans, including those not receiving Medicare. The bill is opposed by PhRMA, as well as the state’s powerful Culinary Union, which has supported previous state drug pricing legislation. PhRMA said the Nevada bill sets an arbitrary price cap in Nevada based on federal decisions that would restrict patients’ access to medicines. The Culinary Union believes AB 250 is too drastic in its scope. Despite this opposition, the bill passed the Nevada Assembly 27-15 and is now under consideration in the Senate.