Health Care Checkup
November 12, 2021
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Late last Friday, the House voted 228-206 to pass the Infrastructure Investment and Jobs Act. The legislation will invest $550 billion in new funding toward the nation’s aging infrastructure, including highways, bridges, public transit, airports, and power grids. The bill also includes funding to help mitigate climate change and make drinking water cleaner. The passage came after months of negotiation and marked a win for President Joe Biden. Since the Senate already passed the legislation in August, Biden plans to sign it into law on Monday, and the House is expected to continue work on the reconciliation bill (Build Back Better Act), when it comes back next week.
The Congressional Budget Office (CBO) announced Tuesday that it is in the process of preparing a cost estimate for the current version of H.R. 5376, the Build Back Better Act and plans to release estimates for individual titles of the bill as soon as they are completed, with smaller titles already completed this week. However, the CBO said that it cannot give a definitive date for when it will have a final cost estimate score of the bill, potentially pushing the timing back in the House due to moderate Democrats who have indicated they want a complete CBO score before voting on the package.
After last week’s workplace vaccine mandate was released by the Biden Administration, Missouri, Montana, Arizona and Nebraska led an 11-state coalition in filing a lawsuit against the Administration over the mandate. As a reminder, the Occupational Safety and Health Administration’s emergency temporary standard (ETS) requires that companies with 100 or more employees require their personnel to either get fully vaccinated against COVID-19 by January 4, 2022 or submit to weekly testing. The suit alleges that the mandate is “unconstitutional, unlawful, and unwise.” It also asserts that, “The federal government lacks constitutional authority under its enumerated powers to issue [the] mandate, and its attempt to do so unconstitutionally infringes on the States’ powers expressly reserved by the Tenth Amendment.” On Friday, a federal appeals court in New Orleans halted the Biden Administration’s ETS. The Biden Administration has since asked the federal appeals court to lift the temporary order blocking the ETS. A lawyer for the Administration stated, “There is no need to address petitioners’ stay motions now, and the Court should lift its administrative stay and allow this matter to proceed under the process that Congress set forth for judicial review of OSHA standards.” We will continue to monitor this situation as it unfolds.
On Tuesday, Pfizer asked the Food and Drug Administration (FDA) to amend its emergency use authorization (EUA) for COVID-19 booster shots to include all adults. Currently, booster doses of Pfizer’s COVID-19 vaccine are only authorized for adults ages 65 and older, adults who are immunocompromised, and adults whose occupational setting puts them at higher risk of contracting the virus. The FDA will review the request and may also schedule a meeting of its advisory panel to review it.
On Monday, the U.S. Department of Health and Human Services (HHS) Office on Women’s Health announced a new HHS Perinatal Improvement Collaborative with Premier, Inc to improve health outcomes for mothers and infants. 200 hospitals across the country will participate in this initiative to “evaluate how pregnancy affects overall population health by linking inpatient data of newborns to their mothers.” Each participating hospital will capture more than 150 measures in hopes of gaining a better understanding of the clinical and non-clinical factors that impact overall maternal and infant health outcomes. A list of the participating hospitals and more information on the collaborative can be found here.
The Centers for Medicare & Medicaid Services (CMS) announced their decision to repeal the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” (MCIT/R&N) final rule over concerns that “the provisions in the final rule may not have been sufficient to protect Medicare patients.” However, CMS has stated their intentions to continue to search for alternative coverage process improvements to increase access to new and better medical devices for people with health care needs under Medicare. In addition, this will also establish a process for the Medicare program to cover new technologies “on the basis of scientifically sound clinical evidence, with appropriate health and safety protections in place for the Medicare population.” Lastly, despite the repeal of this final rule, coverage for specific medical devices or services may still be covered through claim-by-claim determinations, under one or more local coverage determinations, or a national coverage determination. Please see the final rule and press release attached.
After a months-long search for the new Food and Drug Administration (FDA) Commissioner, President Biden will nominate Robert M. Califf to lead the agency. Califf is no stranger to the FDA and previously served as Commissioner under former President Obama from 2016 to 2017. While his previous nomination faced some push back from Democrats over his close ties to the pharmaceutical industry, he was ultimately confirmed by the Senate in a 89-4 vote. Califf also served as Deputy Commissioner of the United States Food and Drug Administration's Office of Medical Products and Tobacco and is a trained cardiologist.
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What to Expect Next Week: On Wednesday, November 17, the House Veterans' Affairs Subcommittee on Disability Assistance and Memorial Affairs will hold a hearing titled, “Supporting Survivors: Assessing VA's Military Sexual Trauma Programs;” the House Education and Labor Subcommittee on Early Childhood, Elementary, and Secondary Education and Subcommittee on Higher Education and Workforce Investment will hold a joint hearing titled, “Examining the Implementation of COVID-19 Education Funds;” and the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies will hold a hearing titled, “ U.S. Role in Global COVID-19 Vaccine Equity.”
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House Passes Bipartisan Infrastructure Bill
Late last Friday, the House voted 228-206 to pass the Infrastructure Investment and Jobs Act. The legislation will invest $550 billion in new funding toward the nation’s aging infrastructure, including highways, bridges, public transit, airports, and power grids. The bill also includes funding to help mitigate climate change and make drinking water cleaner. The passage came after months of negotiation and marked a win for President Joe Biden. Since the Senate already passed the legislation in August, Biden plans to sign it into law on Monday, and the House is expected to continue work on the reconciliation bill (Build Back Better Act), when it comes back next week.
Latest on Reconciliation Timing
The Congressional Budget Office (CBO) announced Tuesday that it is in the process of preparing a cost estimate for the current version of H.R. 5376, the Build Back Better Act and plans to release estimates for individual titles of the bill as soon as they are completed, with smaller titles already completed this week. However, the CBO said that it cannot give a definitive date for when it will have a final cost estimate score of the bill, potentially pushing the timing back in the House due to moderate Democrats who have indicated they want a complete CBO score before voting on the package.
States Sue Biden Administration Over Vaccine Mandate
After last week’s workplace vaccine mandate was released by the Biden Administration, Missouri, Montana, Arizona and Nebraska led an 11-state coalition in filing a lawsuit against the Administration over the mandate. As a reminder, the Occupational Safety and Health Administration’s emergency temporary standard (ETS) requires that companies with 100 or more employees require their personnel to either get fully vaccinated against COVID-19 by January 4, 2022 or submit to weekly testing. The suit alleges that the mandate is “unconstitutional, unlawful, and unwise.” It also asserts that, “The federal government lacks constitutional authority under its enumerated powers to issue [the] mandate, and its attempt to do so unconstitutionally infringes on the States’ powers expressly reserved by the Tenth Amendment.” On Friday, a federal appeals court in New Orleans halted the Biden Administration’s ETS. The Biden Administration has since asked the federal appeals court to lift the temporary order blocking the ETS. A lawyer for the Administration stated, “There is no need to address petitioners’ stay motions now, and the Court should lift its administrative stay and allow this matter to proceed under the process that Congress set forth for judicial review of OSHA standards.” We will continue to monitor this situation as it unfolds.
Pfizer Requests FDA Amend its EUA to Allow for all Adults to Receive its COVID-19 Booster
On Tuesday, Pfizer asked the Food and Drug Administration (FDA) to amend its emergency use authorization (EUA) for COVID-19 booster shots to include all adults. Currently, booster doses of Pfizer’s COVID-19 vaccine are only authorized for adults ages 65 and older, adults who are immunocompromised, and adults whose occupational setting puts them at higher risk of contracting the virus. The FDA will review the request and may also schedule a meeting of its advisory panel to review it.
HHS Announces 200 Hospitals Participating in New Collaborative to Improve Maternal and Infant Health Outcomes
On Monday, the U.S. Department of Health and Human Services (HHS) Office on Women’s Health announced a new HHS Perinatal Improvement Collaborative with Premier, Inc to improve health outcomes for mothers and infants. 200 hospitals across the country will participate in this initiative to “evaluate how pregnancy affects overall population health by linking inpatient data of newborns to their mothers.” Each participating hospital will capture more than 150 measures in hopes of gaining a better understanding of the clinical and non-clinical factors that impact overall maternal and infant health outcomes. A list of the participating hospitals and more information on the collaborative can be found here.
CMS t0 repeal the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” (MCIT/R&N) final rule
The Centers for Medicare & Medicaid Services (CMS) announced their decision to repeal the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” (MCIT/R&N) final rule over concerns that “the provisions in the final rule may not have been sufficient to protect Medicare patients.” However, CMS has stated their intentions to continue to search for alternative coverage process improvements to increase access to new and better medical devices for people with health care needs under Medicare. In addition, this will also establish a process for the Medicare program to cover new technologies “on the basis of scientifically sound clinical evidence, with appropriate health and safety protections in place for the Medicare population.” Lastly, despite the repeal of this final rule, coverage for specific medical devices or services may still be covered through claim-by-claim determinations, under one or more local coverage determinations, or a national coverage determination. Please see the final rule and press release attached.
Biden Taps Robert Califf to be FDA commissioner
After a months-long search for the new Food and Drug Administration (FDA) Commissioner, President Biden will nominate Robert M. Califf to lead the agency. Califf is no stranger to the FDA and previously served as Commissioner under former President Obama from 2016 to 2017. While his previous nomination faced some push back from Democrats over his close ties to the pharmaceutical industry, he was ultimately confirmed by the Senate in a 89-4 vote. Califf also served as Deputy Commissioner of the United States Food and Drug Administration's Office of Medical Products and Tobacco and is a trained cardiologist.
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SENATE HEARINGS AND EXECUTIVE SESSIONS |
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HOUSE HEARINGS AND EXECUTIVE SESSIONS |
Wednesday, November 17, at 10:00 AM ET
House Committee on Veterans' Affairs - Hearing
Subcommittee on Disability Assistance and Memorial Affairs Hearing: Supporting Survivors: Assessing VA's Military Sexual Trauma Programs
Wednesday, November 17, at 10:15 AM ET
House Committee on Education and Labor - Hearing
Subcommittee on Early Childhood, Elementary, and Secondary Education (Committee on Education and Labor) and Subcommittee on Higher Education and Workforce Investment (Committee on Education and Labor) Joint Hearing: Examining the Implementation of COVID-19 Education Funds
Wednesday, November 17, at 10:30 AM ET
House Committee on Appropriations - Hearing
Subcommittee on Labor, Health and Human Services, Education, and Related Agencies Hearing: U.S. Role in Global COVID-19 Vaccine Equity
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ADMINISTRATION ANNOUNCEMENTS |
Centers for Medicare & Medicaid Services
- CMS Releases Updated COVID-19 Medicaid and CHIP Data Snapshot for Services through May 2021: To monitor the impact of the COVID-19 public health emergency (PHE), the Centers for Medicare & Medicaid Services (CMS) conducted extensive data analysis using the Transformed Medicaid Statistical Information System (T-MSIS) Analytic Files (TAF) and is releasing an updated Medicaid and Children’s Health Insurance Program (CHIP) data snapshot that provides insight into the impact of COVID-19 on beneficiaries and service utilization through May 2021. Specifically, CMS is releasing updated data that examines:
- Monitoring COVID-19: enrollment, treatment, acute care use, and testing;
- Service use among Medicaid & CHIP beneficiaries under age 19 during the COVID-19 PHE;
- Services delivered via telehealth to Medicaid and CHIP beneficiaries during the COVID-19 PHE;
- Services for mental health and substance use disorders (SUDs) among Medicaid & CHIP beneficiaries during the COVID-19 PHE; and
- Reproductive health services for female Medicaid and CHIP beneficiaries during the COVID-19 PHE.
- Click here for the full list of all new CMS updates.
Food and Drug Administration
Guidance Documents from the Centers for Disease Control and Prevention
National Institutes of Health
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