What’s Ahead: This Week

Hearings & Markups –

  • Tuesday, May 17
    • House Appropriations Committee, Military Construction, Veterans Affairs, and Related Agencies Subcommittee, “FY23 VA Electronic Health Record Modernization Budget Hearing.” Additional information
  • Wednesday, May 18
    • Senate HELP Committee, “Cybersecurity in the Health and Education Sectors.” Additional information
    • House Judiciary Committee, “Revoking Your Rights: The Ongoing Crisis in Abortion Care Access.” Additional information
  • Thursday, May 19
    • Senate Special Committee on Aging, “Mental Health Care for Older Adults: Raising Awareness, Addressing Stigma, and Providing Support” Additional information
    • House Appropriations Committee, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Subcommittee, “Fiscal Year 2023 Budget Request for the Food and Drug Administration.” Additional information

Notable Policy Events –

Weekly Wrap-Up: Notable Health Care Developments from Last Week

COVID-19 Surveillance, Funding, Oversight and Data

  • Data: To date, there are 82,302,126 total COVID-19 cases and 997,083 COVID-19 deaths in the United States. Also, 736,970,055 COVID-19 vaccines have been delivered and 581,670,838 individual COVID-19 vaccine doses have been administered. Data
  • FDA Action Update: To date, FDA has authorized 432 tests under Emergency Use Authorizations (EUAs), including 297 molecular tests, 84 antibody tests and 50 antigen tests. FDA also continues to update COVID-19 FAQs.
  • On May 10, Committee on Oversight and Reform Chair Maloney (D-NY) and Select Subcommittee on the Coronavirus Crisis Chair Clyburn (D-SC) released a staff report on their joint investigation into coronavirus vaccine manufacturing failures of Emergent BioSolutions, Inc. Press release Report
  • On May 12, U.S. General Accountability Office (GAO) released a report with recommendations for the FDA around how to handle the use of unauthorized tests in a future public health emergency. Overview Highlights Full report
  • Also on May 12, President Biden and HHS Secretary Becerra released statements acknowledging the milestone ot one million American lives lost to COVID-19. White House press release HHS Press release
  • Also on May 12, Republican Whip and Select Subcommittee on the Coronavirus Crisis Ranking Member Scalise (R-LA), House Committee on Oversight and Reform Ranking Member Comer (R-KY), and Rep. Biggs (R-AZ), along with 19 other Republican lawmakers, called on Oversight and Reform Committee Chair Maloney (D-NY) and Select Subcommittee Chair Clyburn (D-SC) to hold an oversight hearing on CDC’s response to the COVID-19 pandemic. Press release Lhttps://www.hhs.gov/sites/default/files/styles/hero_billboard/public/covid-hero-image-720×533.jpg?itok=3giDsNFletter

Medicare, Medicaid & Marketplaces –

  • On May 9, HHS Office of the Inspector General (OIG) released a report finding twenty-five percent of Medicare patients experienced patient harm during their hospital stays in October 2018. Overview Complete report
  • Also on May 9, HHS OIG released a report finding HHS met many requirements, but it did not fully comply with the Payment Integrity Information Act of 2019 and Applicable Improper Payment Guidance for the Fiscal Year 2021. Overview Report
  • Also on May 9, Senate Special Committee on Aging Chair Casey (D-PA) raised concerns about the timeliness of inspections at poor performing nursing homes in a letter sent to CMS Administrator Brooks-LaSure. Press release Letter
  • On May 11, Senate HELP Committee Ranking Member Burr (R-NC), Senate Banking, Housing and Urban Affairs Committee Ranking Member Toomey (R-PA) and Sen. Cassidy (R-LA) sent a letter to Internal Revenue Service (IRS) Commissioner Charles Rettig asking for additional information around the IRS proposed “Family Glitch” rule. Press release Letter
  • On May 12, CMS released new guidance around Medicaid and CHIP coverage and payment of stand-alone vaccine counseling. This guidance covers when a patient receives counseling about vaccines without receiving a vaccine at the same time. Guidance
  • Also on May 12, CMS released a final rule related to Reassignment of Medicaid Provider Claims. This final rule authorizes States to make payments to third parties on behalf of individual practitioners, for individual practitioners’ health insurance and welfare benefits, skills training, and other benefits customary for employees. Final rule
  • Also on May 12, HHS released a report that explores the evidence for using assistive technologies and home modifications for lifting, transferring, and repositioning to reduce homecare worker injuries. Overview Report

Payment and Delivery System Models –

  • On May 12, CMS announced the CY 2023 Benchmarks and Achievement Thresholds for the Expanded Home Health Value-Based Purchasing Model. The model was designed to incentivize all Medicare-certified home health agencies to provide higher quality and more efficient care within the Medicare Home Health Prospective Payment System. Overview Access instructions

Mental Health and Substance Use Disorder Policy –

  • On May 9, Reps. Pappas (D-NH) and Bacon (R-NE) led their 18 of their colleagues in a bipartisan letter to HHS Secretary Becerra calling on him to update the Public Health Emergency declaration that an opioid public health emergency exists nationwide to include stimulants, and especially methamphetamines. Press release Letter
  • On May 10, HHS released a press release about HHS Secretary Becerra’s travel to the Pacific Northwest to discuss the Biden Administration’s effort to tackle the nation’s mental health crisis. Press release

Digital Health, Health IT and Privacy –

  • On May 11, the Office of the National Coordinator for Health IT (ONC) released a blog post about the advancements from the Strengthening the Technical Advancement & Readiness of Public Health via Health Information Exchange Program (The STAR HIE Program). The initial STAR HIE Program was expanded in 2021 to further support efforts to increase vaccination data sharing between jurisdictional Immunization Information Systems (IIS) and HIEs. Blog
  • On May 11, ONC announced that Leidos has been granted status as an ONC-Authorized Testing Laboratory (ONC-ATL) in the ONC Health IT Certification Program. Leidos now becomes one of four organizations to hold current ONC-ATL status alongside Drummond Group, ICSA Labs, and SLI Compliance. Blog

Veteran Health and Military Health –

  • On May 10, VA OIG released a report that assessed how the Veterans Health Administration (VHA) addressed the emotional well-being of employees during the COVID-19 pandemic. The OIG recommended increasing leadership and staff awareness of COVID-19 emotional well-being resources for VHA employees and awareness of resources about potential risks and signs of burnout. Overview Report
  • On May 12, GAO released a report with recommendations for VA to meet its infrastructure needs, such as accepting facility donations from non-federal entities and integrating facilities with DOD. Overview Highlights Full report

Public Health and Health Equity–

  • On May 9, Indian Health Service (HIS) announced $5 million to target resources directly to tribes, tribal organizations, urban Indian organizations, and IHS direct service facilities to address Alzheimer’s disease within tribal communities. Press release
  • On May 10, CDC released new data about firearm homicides and suicides. Firearms were involved in 79 percent of all homicides and 53 percent of all suicides in 2020. The report also found a widening of racial, ethnic, and other disparities. Press release Quick stats
  • On May 11, HHS announced the availability of $5 million for community health centers to increase equitable access to life-saving cancer screenings. Press release
  • Also on May 11, the White House announced private sector commitments to increasing cancer screening as part of Cancer Moonshot Initiative. Fact sheet
  • On May 12, HHS Secretary Becerra hosted the first in-person meeting of the President’s Advisory Commission on Asian Americans, Native Hawaiians, and Pacific Islanders. The Commission advises the President on ways the public, private and non-profit sectors can work together to advance equity, justice, and opportunity for Asian American, Native Hawaiian, and Pacific Islander communities. Press release
  • On May 13, HHS released the National Action Plan for Combating Antibiotic-Resistant Bacteria Progress Report for Year 5, which summarizes major accomplishments achieved between 2015 and 2020 in combatting antibiotic resistant bacteria. Overview Report
  • Also on May 13, CMS released a new report about Malignant Mesothelioma Mortality in Women, finding the annual number of deaths increased significantly from 1999 to 2020. The largest number of deaths in 2020 was associated with the health care and social assistance industry and homemaker occupation. Report

Women’s Health –

  • On May 10, Reps. Fletcher (D-TX) and Bush (D-MO) led a letter, with 98 other lawmakers, to CMS Administrator Brooks-LaSure to urge the immediate enforcement of Medicaid’s free choice of provider requirement. The federal “free choice” provision, also known as the “any willing provider” provision, guarantees Medicaid enrollees the right to receive family planning services from any willing and qualified provider. Press release Letter
  • Also on May 10, HHS awarded $16.3 million in grant funding to support 31 grantees to enhance and expand the telehealth infrastructure and capacity of Title X family planning clinics in 26 states, one U.S. territory, and one freely associated state. Press release
  • Also on May 10, Reps. Casten (D-IL), Bush (D-MO), Crow (D-CO), Lee (D-CA), DeGette (D-CO), and Chu (D-CA) sent a letter to Senate Leadership signed by 113 House colleagues calling on the Senate to abolish the filibuster to protect abortion rights by passing the Women’s Health Protection Act. Press release Letter
  • On May 11, President Biden released a statement about the Senate’s failure to pass the Women’s Health Protection Act to codify the right to abortion. Press release

Misc. –

  • On May 9, the Biden Administration announced new actions to ensure that all households eligible for the Affordable Connectivity Program can take advantage of the program. The Biden Administration also announced it had secured commitments from 20 internet providers to cut prices and increase speeds. Fact sheet
  • On May 12, President Biden announces additional steps to address infant formula shortage including simplifying product offerings to get formula to consumers faster and cracking down on any price gouging activity. Fact sheet
  • Also on May 12, House Energy & Commerce Committee Ranking Member McMorris Rodgers (R-WA) and 106 of her House Republican colleagues sent a letter to President Biden and FDA Commissioner Califf asking them to explain their plan for handling the nationwide formula shortage. Press release Letter
  • On May 13, Senate HELP Committee Chair Murray (D-WA) and Senator Casey (D-PA) led 30 of their Democratic colleagues in sending a letter to Mardi Mountford, President of the Infant Nutrition Council of America, calling on infant formula manufacturers to address the formula shortage. Press release Letter
  • Also on May 13, Committee on Oversight and Reform Chair Maloney (D-NY) and Rep. Krishnamoorthi (D-IL) sent letters to four baby formula manufacturers—Abbott Nutrition, Mead Johnson Nutrition, Nestlé USA, and Perrigo Company—requesting information on the steps these companies are taking to address the shortage of infant formula. Press release Abbott NutritionMead Johnson NutritionNestlé USA, Perrigo Company

Legislative Activity –

Votes and Committee Activity –

  • On May 11, the Energy & Commerce Health Subcommittee marked up six bills. Press release
    • The Food and Drug Amendments of 2022 (H.R. 7667), was forwarded, as amended, to the Full Committee by a vote of 30-0.
    • The Restoring Hope for Mental Health and Well-Being Act (H.R. 7666) was forwarded, without amendment, to the Full Committee by a vote of 32-0.
    • The KIDS CARES Act (H.R. 7233) was forwarded, as amended, to the Full Committee by a vote of 32-0.
    • The Gabriella Miller Kids First Research Act 2.0. (H.R. 623) was forwarded, as amended, to the Full Committee by a voice vote.
    • The South Asian Heart Health Awareness Act of 2021 (H.R. 3771), was forwarded, as amended, to the Full Committee by a voice vote.
    • The Advanced Research Project Agency (ARPA-H) Act (H.R. 5585) was forwarded, without amendment, to the Full Committee by voice vote.

Introduced Legislation –

  • On May 9, Sen. Bennet (D-CO) introduced the School Shooting Safety and Preparedness Act (S.4162), which would require the Secretary of Education, in consultation with the Attorney General and the Secretary of Health and Human Services, to publish an annual report on indicators of school crime and safety that includes data on school shootings. Bill text One Pager Press release
  • Also on May 9, Sens. Rubio (R-FL) and Lee (R-UT) introduced the Conscience Objections to Negligent State COVID-19 Inoculation Edicts Need Constitutional Enforcement (CONSCIENCE) Act (S. 4163), which would prohibit the imposition of certain substantial burdens, relating to COVID-19 vaccine mandates, on religious exercise. Bill text Press release
  • Also on May 10, Del. Norton (D-DC) introduced the Promoting Healthier Lifelong Improvements in Food and Exercise (LIFE) Act (H.R.7711), which would provide for a national program to conduct and support activities toward the goal of significantly reducing the number of cases of overweight and obesity among individuals in the United States. Press release
  • Also on May 10, Sens. Tester (D-MT), Moran (R-KS), and Murray (D-WA) introduced the Expanding Veterans’ Options for Long Term Care Act (S.4169), which would require the Secretary of Veterans Affairs to carry out a pilot program to provide assisted living services to eligible veterans. Bill text Press release
  • Also on May 10, Sens. Cassidy (R-LA) and Murphy (D-CT) introduced the Mental Health Reform Reauthorization Act of 2022 (S.4170), which would reauthorize programs for mental health. Bill text One Pager Press release
  • Also on May 10, Sen. Cruz (R-TX) and 13 cosponsors introduced the Allowing Military Exemptions, Recognizing Individual Concerns About New Shots (AMERICANS) Act of 2022 (S.4172), which would modify the limitation on discharge of members of the Armed Forces solely on the basis of failure to obey a lawful order to receive a vaccine for COVID-19. Bill text Press release
  • On May 11, Rep. Feenstra (R-IA) and Bice (R-OK) introduced the Formula Act (H.R.7718), which would review and update internationally recognized standards for infant formula to ensure that such standards are consistent with the requirements applicable to the importation of infant formula into the United States. Press release
  • Also on May 11, Sen. Baldwin (D-WI) and 26 cosponsors introduced the Workplace Violence Prevention for Health Care and Social Service Workers Act (S.4182), which would direct the Secretary of Labor to issue an occupational safety and health standard that requires covered employers within the health care and social service industries to develop and implement a comprehensive workplace violence prevention plan. Bill text Press release Summary
  • Also on May 11, Sens. Baldwin (D-WI) and Cassidy (R-LA) introduced the Retaining Access and Restoring Exclusivity (RARE) Act (S.4185), which would set forth limitations on exclusivity for orphan drugs. Press release Summary
  • On May 12, Rep. DeSaulnier (D-CA) introduced the Employee and Retiree Access to Justice Act (H.R.7740), which would provide that any mandatory predispute or coerced postdispute arbitration clause, class action waiver, representation waiver, or discretionary clause with respect to a plan is unenforceable, to prohibit any such clause or waiver from being included in a plan document or other agreement with plan participants. Sen. Smith (D-MN) introduced companion legislation in the Senate (S.4219). Press release
  • Also on May 12, Reps. Guthrie (R-KY), Dean (D-PA) and McKinley (R-WV) introduced the Building America’s Health Care Workforce Act (H.R.7744), which would extend beyond the COVID-19 emergency period, with certain modifications, the Emergency Declaration Blanket Waiver relating to training and certification of nurse aides to alleviate burdens imposed on staff of skilled nursing facilities and nursing facilities. Press release
  • Also on May 12, Rep. Pappas introduced the Preventing Homelessness for Veteran Families Act (H.R.7753), which would extend authority for supportive services for very low-income veteran families in permanent housing. Press release
  • Also on May 12, Rep. Sewell (D-AL) and five cosponsors introduced the John Lewis Equality in Medicare and Medicaid Treatment (EMMT) Act (H.R.7755), which would improve access to care for all Medicare and Medicaid beneficiaries through models tested under the Center for Medicare and Medicaid Innovation. On April 7, Sen. Booker(D-NJ),Padilla (D-CA) and Brown (D-OH) introduced companion legislation in the Senate (S.4067). Press release
  • Also on May 12, Sens. Menendez (D-NJ) and Collins (R-ME) introduced the Autism Family Caregivers Act (S.4198), which would award grants for providing evidence-based caregiver skills training to caregivers of children with autism spectrum disorder and other developmental disabilities. Press release
  • Also on May 12, Sen. Sanders (D-VT) and 14 cosponsors introduced (S.4204), which would establish a Medicare-for-all national health insurance program. Bill text Press release Summary Fact sheet
  • Also on May 12, Sen. Kennedy (R-LA) introduced the Mother and Baby Formula Safety Act (S.4212), which would require the Food and Drug Administration to publish guidelines for parents to prepare baby formula at home. Bill text Press release
  • Also on May 12, Sens. Rubio (R-FL) and Bennet (D-CO) introduced the Give Kids a Chance Act (S.4215), which would establish additional authorities of the Food and Drug Administration regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer. Press release