Legislative Update – Week of March 20, 2023

Mar 21, 2023

Last week in DC, ARPA-H, announced that the Washington region will serve as the first of three hubs for the agency, and that it has opened up site solicitation to find the remaining two hubs to be located outside the capital region. The agency plans to announce those sites by the fall. The request for proposals timeline includes a listening session on March 24 with whitepapers to be submitted by April 7. Massachusetts is one of the states that is vying for a Hub.

CMS released two important pieces of information related to the Inflation Reduction Act. First, CMS released the initial negotiation guidance. This initial guidance describes how CMS intends to implement the Negotiation Program for initial price applicability year 2026 (January 1, 2026 to December 31, 2026.) CMS is also voluntarily soliciting comment on certain topics in this memorandum where noted. Comments are due by April 14, 2023. CMS will issue revised guidance for initial price applicability year 2026 after considering the public comments received in response to this initial guidance.

In addition, CMS announced 27 Part B drug and biological products for which Part B beneficiary coinsurances may be lower from April 1 – June 30, 2023. CMS also released information about these 27 products in the quarterly ASP public file, available here. A fact sheet is available here.

Last week in Massachusetts, the Healey Administration announced that they will lift the state’s modified COVID-19 public health emergency effective May 11. Governor Healey also plans to walk back a vaccine mandate for tens of thousands of executive branch workers. The end to the state-level public health emergency aligns with the May 11 end of the federal public health emergency.

The Center for Health Information and Analysis (CHIA) released its 2023 Annual Report on the Performance of the Massachusetts Health Care System. It was different than in past years as it assesses two years of spending data offering a three-year trend 2019 – 2021. https://www.chiamass.gov/annual-report/ . The report stated that net spend increased 7.5% 2019-2021 making it the fastest growing three year spend category (and much higher than the ~3% it had been averaging for years).

MassBio’s statement on the report:“Although the CHIA report does not analyze why pharmacy spend increased during this time period, if national trends are any indication, increases in utilization are the most likely cause, not increased cost of drugs. During a pandemic an increase in the utilization of medicines that can keep people healthy and out of the hospital should be viewed as money well spent. The real cause for concern is that member cost-sharing increased 16.9% forcing patients to pay more out of their pocket for their healthcare despite total healthcare spending only increasing by 3.2% in those three years.”

This week in DC, the Health, Education, Labor, and Pensions (HELP) Committee will hold a hearing entitled, “Taxpayers Paid Billions For It: So Why Would Moderna Consider Quadrupling the Price of the COVID Vaccine?” The hearing will take place on Wednesday, March 22, 2023, at 10:00 a.m. Witnesses include: Stéphane Bancel, Moderna; Christopher J. Morten, Ph.D., J.D., Columbia Law School; Ameet Sarpatwari, Ph.D., J.D., Harvard Medical School; and Craig Garthwaite, Ph.D., M.P.P., Kellogg School of Management, Northwestern University.

See all MassBio News