The following is the latest health policy news from the federal government as of 2:15 p.m. on Monday, June 21. Some of the language used below is taken directly from government documents.
Supreme Court Decision in Affordable Care Act Challenge
- The Supreme Court upheld the constitutionality of the Affordable Care Act in the California v. Texas case by a 7-2 vote in which the court concluded that the plaintiffs did not have standing to pursue the matter because they were not directly harmed. See the court’s opinion here.
- The White House has posted a transcript of the June 17 press briefing given by its COVID-19 response team and public health officials.
Department of Health and Human Services
- HHS’s Office of the Assistant Secretary for Preparedness and Response (ASPR) has suspended distribution of the monoclonal antibodies bamlanivimab/etesevimab in Rhode Island because of the rising prevalence in that state of the COVID-19 P.1 (Gamma) variant (first identified in Brazil) and the B.1.351 (Beta) variant (first identified in South Africa) and the relative ineffectiveness of these therapies in fighting these variants. ASPR has already suspended distribution of these monoclonal antibodies in Arizona, California, Florida, Indiana, Oregon, Washington, Illinois, and Massachusetts for the same reason and recommends the use of alternative therapies. Go here for further information.
- HHS announced that the administration will invest more than $3 billion in American Rescue Plan money to accelerate the discovery, development, and manufacture of antiviral medicines as treatments for COVID-19 and other viruses. For more information on the plan and how the $3 billion will be allocated, see the HHS announcement.
- HHS and its Office of the National Coordinator for Health Information Technology (ONC) announced the establishment of an $80 million Public Health Informatics & Technology Workforce Development Program (PHIT Workforce Program) to strengthen U.S. public health informatics and data science. As part of this launch, ONC is inviting colleges and universities – particularly Historically Black Colleges and Universities (HBCUs), Tribal Colleges and Universities (TCUs), Hispanic Serving Institutions (HSIs), Asian American and Native American Pacific Islander-Serving Institutions (AANAPISIs), and other minority-serving institutions (MSIs) to apply for funding through a consortium that will develop the curriculum, recruit and train participants, secure paid internship opportunities, and assist in career placement at public health agencies, public health-focused non-profits, or public health-focused private sector or clinical settings. Learn more about the program from this HHS announcement and this notice of the funding opportunity. Applications are due August 11.
Health Policy News
- HHS’s Office of the National Coordinator for Health Information Technology (ONC), in collaboration with standards development organizations and others, has released the Project US@ (‘USA’) Draft Technical Specification Version 1.0 for public comment. Project US@ was created to develop a unified, cross-standards, health care industry-wide specification for representing patient addresses to improve patient matching. See the HHS/ONC announcement about the release here and find the draft specifications here. Comments are due July 31.
- The White House has nominated Christi Grimm to be HHS’s inspector general. The position is subject to Senate confirmation. Learn more about her here.
- Medicaid enrollment rose by nearly 9.9 million individuals, a 13.9 percent increase, between February 2020, the month before the COVID-19 emergency was declared, and the end of January 2021. Among the 50 states and the District of Columbia more than 80.5 million people were enrolled and receiving full benefits from the Medicaid and CHIP programs by the end of January 2021. Learn more from this HHS news release.
Centers for Medicare & Medicaid Services
- CMS has written a letter about hospital recertification survey suspensions that may become necessary due to new COVID-19 case surges. The last national hospital survey suspension expired on March 23, 2021, and while CMS has concluded that extending the suspension is not merited, it outlines in the letter the conditions under which it will consider suspending individual surveys. See the CMS letter here.
- On May 11 CMS published an interim final rule with comment period that added new COVID-19 vaccination reporting requirements for nursing home staff and residents and provided a four-week grace period for facilities to educate themselves on the new requirements and to operationalize reporting. On June 10 CMS posted the first set of weekly nursing home COVID-19 vaccination data, which includes vaccination status of both residents and staff, as reported by facilities. Current data shows that at nursing homes that have reported, approximately 75 percent of residents and 50 percent of staff have received a COVID-19 vaccine. Learn more from the Nursing Home Data web site.
Health Policy News
- CMS has published the latest edition of MLN Connects, its online publication. For articles about monoclonal antibodies, HCPCS coding additions, and more, go here.
Centers for Disease Control and Prevention
- The CDC has updated its provider agreements for those administering COVID-19 vaccines to reinforce that participants may not sell or divert vaccines or reproduce vaccination record cards without the CDC’s written permission. Go here for further information.
- The CDC has updated its guidance on COVID-19 vaccines for women who are pregnant or breastfeeding.
- The CDC has updated its guidance on COVID-19 vaccines for people with underlying medical conditions.
- The CDC has updated its guidance on daily activities and going out for people who are fully vaccinated against COVID-19.
- The CDC has updated its pediatric health care professionals’ vaccination toolkit.
Food and Drug Administration
- The FDA has translated its Pfizer vaccine fact sheet for recipients and caregivers into additional languages. Find the complete collection here.
- The FDA has approved a nasal antihistamine for non-prescription use through a process called a partial prescription to non-prescription switch. The FDA approved Astepro (azelastine hydrochloride nasal spray, 0.15 percent) for seasonal and perennial allergic rhinitis for adults and children six years of age and older. See the FDA announcement here.
Tuesday, June 22 – FDA
FDA Drug Topics: Overview of Risk Evaluation and Mitigation Strategies (REMS) for Health Care Providers
Tuesday, June 22 at 1:00 – 2:15 pm ET Click here to learn more
This webinar will provide an overview of REMS and discuss how REMS safety requirements affect prescribers, dispensers, and patients. Participants should gain an understanding of the REMS authorities, how REMS are implemented, and the entities that provide oversite and support. REMS is a drug safety program that the FDA can require for certain medications with serious safety concerns to help ensure that the benefits of the medication outweigh its risks.
Wednesday, Thursday, and Friday, July 7, July 8, and July 9 – CMS
CMS – Revisions to the Healthcare Common Procedure Coding System (HCPCS) Code Set
CMS will hold virtual meetings on July 7, 8, and 9, to discuss its preliminary coding recommendations for revisions of the HCPCS Level II code set. For information about times, registration, submission of materials, signing up to speak, and submitting comments, click here.
CMS – Coronavirus (COVID-19) Stakeholder Calls
HHS’s “We Can Do This” campaign is a national initiative to build confidence in COVID-19 vaccines and get more people vaccinated. This campaign offers tailored resources and toolkits for stakeholders to use to provide COVID-19 vaccine information to at-risk populations. CMS is partnering with the campaign to offer several webinars to walk through each toolkit and its resources and train community organizations, local voices, and trusted leaders to use the campaign tools for vaccine outreach efforts to diverse communities. Webinar dates and registration links are below:
- Tuesday, June 22, 1:00-1:30 pm ET: Spanish Language Toolkits – Register here
- Thursday June 24, 1:00-1:30 pm ET: Healthcare workers Toolkit – Register here
- Tuesday, June 29, 1:00-1:30 pm ET: Faith-Based Toolkit – Register here
- Thursday, July 1, 1:00-2:00 pm ET: Toolkits for Racial and Ethnic Minority Communities – Register here
- Thursday, July 8, 1:00-1:30 pm ET: Older Adults Toolkit – Register here