What’s Ahead: This Week

Hearings & Markups –

  • Monday, June 27
    • House Oversight and Reform Committee, “Examining the 2022 National Drug Control Strategy and the Federal Response to the Overdose Crisis.” Additional information
  • Tuesday, June 28
    • House Energy & Commerce Committee, Subcommittee on Oversight and Investigations, “Protecting America’s Seniors: Oversight of Private Sector Medicare Advantage Plans.” Additional information
  •  Wednesday, June 29
    • House Energy & Commerce Committee, Subcommittee on Health, “Investing in Public Health: Legislation to Support Patients, Workers, and Research.” Additional information
  • Friday, July 1
    • Senate Special Committee on Aging, “Affordable Prescriptions Now: Examining Legislation to Lower Costs for Seniors.” Additional information

Notable Policy Events – 

  • Tuesday, June 28
    • U.S. Chamber of Commerce, “9th Annual Health Summit, The Business of Health: Advancing Value and Containing Costs.” Additional information
    • The Atlantic, “The Next Scientific Revolution.” Additional information
    • Food & Drug Administration, “Vaccines and Related Biological Products Advisory Committee Meeting.” Additional information
  • Wednesday, June 29
  • Thursday, June 30
    • The Commonwealth Fund, “Virtual Symposium: Health Care Transformation to Advance Black Maternal Health Equity.” Additional information

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

COVID-19 Surveillance, Funding, Oversight and Data –
  • Data: To date, there are 86,787,443 total COVID-19 cases and 1,011,013 COVID-19 deaths in the United States. Also, 762,236,905 COVID-19 vaccines have been delivered and 593,739,529 individual COVID-19 vaccine doses have been administered. Data
  • FDA Action Update: To date, FDA has authorized 438 tests under Emergency Use Authorizations (EUAs), including 303 molecular tests, 85 antibody tests and 50 antigen tests. FDA also continues to update COVID-19 FAQs.
  • On June 21, CDC released a report on the dispensing of oral antiviral drugs for treatment of COVID-19 by zip code–level social vulnerability between December 23, 2021–May 21, 2022, finding that 1,076,762 oral antiviral prescriptions were dispensed in the United States. The overall number of antivirals dispensed increased; however, by the end of the study period, dispensing rates were lowest in high vulnerability zip codes, despite these zip codes having the largest number of dispensing sites. Report
  • On June 22, HHS Office of Inspector General (OIG) released a report from an audit into influx care facilities (ICFs) and opened emergency intake sites (EISs) to determine whether or not these locations had procedures in place to test for, and protect against the spread of, COVID-19 and report testing and results to the Office of Refugee Resettlement and state and local health entities. The OIG found that most facilities could have done more to meet the CDC and HHS recommendations and requirements designed to keep children safe and protect against the spread of COVID-19. Press Release Report in Brief Report
  • Also on June 22, the CDC  announced that children aged six months to five years with Medicaid and Children’s Health Insurance Program (CHIP) coverage are eligible for COVID-19 vaccinations without cost-sharing. Press Release
  • On June 23, the Government Accountability Office (GAO) released a report on a 2006 requirement for HHS to develop a real-time electronic network that would improve the nation’s situational awareness during a public health emergency. The GAO found that the network is still not operational 15 years later. Therefore, the GAO made 12 recommendations to HHS to prioritize the development of the public health situational awareness and biosurveillance network. Press Release Report Highlights
  • Also on June 23, GAO released a report based on a survey of 24 federal agencies finding that most agencies specified using regulatory flexibilities adapted to meet emergent needs during the COVID-19 pandemic more often than usual. The purpose of the study was to assess flexibilities to help agencies understand their successes or challenges in using such flexibilities. Press Release Report Highlights
  • On June 24, the CDC released a media statement that recommends the Moderna COVID-19 vaccine be used as an option for children ages six through 17 years old, in addition to its already recommended use in children aged six months through five years and adults 18 years and older. Media Statement

Medicare, Medicaid & Marketplaces –

  • On June 21, CMS issued a proposed rule that would update payment rates and policies under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis furnished to Medicare beneficiaries on or after January 1, 2023. CMS projects that the updates in the proposed rule would increase the total payments to all ESRD facilities by 3.1 percent over payments for the calendar year 2022. For rural ESRD facilities, CMS projects an increase in total payments of 2.3 percent, and for urban facilities, CMS projects an increase in total payments of 3.2 percent. These proposals, if finalized, would help ensure that CMS policies are appropriately supporting innovation for new drugs that are truly innovative and not simply variations of existing drugs, as well as ensure that Medicare beneficiaries with ESRD have continued access to technologies that can improve health outcomes and quality of life. Fact Sheet Proposed Rule
  • On June 22, HHS released a fact sheet related to the American Rescue Plan Act (ARPA) which included information on subsidies that sought to lower health care costs and expand access to affordable health coverage. The fact sheet reviewed what would happen to premiums if the extra help from ARPA expires, projecting that more than three million Americans could lose health coverage and more than 10 million could have reduced premium tax credits or lose them entirely. Press Release Fact Sheet
  • On June 23, HHS announced approval of Colorado’s Section 1332 State Innovation Waiver amendment request to create the “Colorado Option,” a state-specific health coverage plan that aims to increase health coverage enrollment and lower health care costs, making insurance more affordable and accessible for nearly 10,000 Coloradans starting in 2023. Press Release  CMS Press Release Fact sheet
  • Also on June 23, House Energy & Commerce Committee Ranking Member McMorris Rodgers (R-WA) and Subcommittee on Oversight and Investigations Ranking Member Griffith (R-VA) invited CMS Administrator Chiquita Brooks-LaSure to testify before the committee during an upcoming hearing on Medicare Advantage (MA). As CMS Administrator, the Members believe she is best positioned to speak to the details and operations of the MA program, including benefits and challenges for those who are enrolled in MA, as well as the oversight that CMS conducts of the program. Press Release Letter
  • Also on June 23, CMS released a report and toolkit by the Medicaid and CHIP Coverage Learning Collaborative for state Medicaid and CHIP agencies to use in the event of a public health emergency or disaster. The report provides a summary overview and inventory of available strategies and authorities available to support Medicaid and CHIP operations and beneficiaries, and the toolkit consists of three modules and serves as a comprehensive preparedness and response toolkit. Report Toolkit

Payment & Delivery System Models 

  • On June 23, CMS released the second annual report for the Pennsylvania Rural Health Model. The report confirmed findings from the first evaluation report that global budgets continued to help stabilize finances for participating hospitals. Report Model Summary

Health IT & Digital Health –

  • On June 21, HHS Office of the National Coordinator for Health IT (ONC) posted a blog providing updates on the Sync for Genes program, launched by ONC in 2017 in partnership with the National Institutes of Health’s All of Us Research Program. ONC highlighted the Sync for Genes Phase 4 Final Report includes more information about the demonstration projects. One key finding was that additional work is needed on integrating genomic information within the clinical record. Blog Post Final Report
  • On June 23, ONC published a blog post on the status of the HL7® Fast Healthcare Interoperability Resources (FHIR) at Scale Taskforce (FAST) initiative. ONC recognized that FAST is now an official HL7 FHIR Accelerator. ONC has joined the FAST FHIR Accelerator as a founding member and encourages other organizations to get involved. Blog Post

Mental Health and Substance Use Disorder Policy –

  • On June 22, the White House Office of National Drug Control Policy (ONDCP) announced the release of a report on Telehealth and Substance Use Disorder Services in the Era of COVID-19. The report outlines several recommendations to improve access to telehealth, including making permanent the regulatory relief granted during the public health emergency which made it easier to access medications for opioid use disorder. Press Release Report

Veterans Health and Military Health  –

  • On June 22, the Veterans Affairs (VA) Office of Inspector General (OIG) evaluated the merits of a May 2021 hotline complaint alleging that the Veterans Benefits Administration (VBA) disregarded privacy procedures so it could more quickly use a workload tracking system without receiving the appropriate security authorization. The OIG found that VBA and the Office of Information and Technology (OIT) did not correctly follow privacy and security procedures. Press Release Report House Committee on Veterans’ Affairs Chairman Statement
  • On June 23, the VA OIG reviewed pharmaceutical proposals submitted to the VA National Acquisition Center for Federal Supply Schedule contracts valued annually at $5 million or more. The reviews are not published because they contain sensitive commercial information protected from release under the Trade Secrets Act. The review team concluded, in part, that commercial disclosures were accurate, complete, and current for four of the 15 proposals reviewed. Press Release Report
  • Also on June 23, the VA encouraged veterans, service members and civilians to take a 50-second self-screen on PTSD Screening Day (June 27) for posttraumatic stress disorder. The short, five-question screen can be answered alone, with a friend, family member or health care provider. Press Release
  • Also on June 23, the Senate Committee on Veterans’ Affairs announced that the VA deployed mobile Vet Centers to areas impacted by major flooding across south-central Montana—including Gardiner-Livingston, Red Lodge, and Fromberg. Mobile Vet Centers provide critical mental health services and support. Press Release

Public Health & Health Equity –

  • On June 21, HHS published a blog post highlighting significant health care challenges, including the health care workforce, data and analytics as related to social determinants of health, and maximizing the role of health services research as key challenges. Blog Post
  • On June 24, HHS announced the prioritization of 13 programs to join President Biden’s Justice40 Initiative, which would ensure that federal agencies deliver 40 percent of the overall benefits of climate, clean energy, affordable and sustainable housing, clean water, and other investments to disadvantaged communities. Press Release
  • Also on June 24, HHS released a request for information on input from persons, communities, health care providers, purchasers and payers, educators, researchers, and other members of the public about what the federal government could do to strengthen primary health care in the U.S. Comments are due by August 1, 2022. RFI

Maternal & Reproductive Health –

  • On June 24, the Supreme Court of the United States ruled 6-3 that the Constitution does not confer a right to abortion and the authority to regulate abortion is returned to the people and their elected representatives. The court upheld Mississippi’s Gestational Age Act (Miss. Code Ann. §41–41–191). Ruling
  • Also on June 24, President Biden announced actions that the Administration plans to take in the wake of the Supreme Court’s decision to overturn Roe v. Wade. The President emphasized in his remarks that Congress must act to restore the protections of Roe v. Wade as federal law, and that the Administration will take action to protect the right to seek medical care and protect access to medication for reproductive health care approved by the FDA. Fact Sheet Remarks CMS Statement HHS Statement
  • Also on June 24, the White House released the Blueprint for Addressing the Maternal Health Crisis, a whole-of-government approach to combatting maternal mortality and morbidity. The Blueprint outlines five priorities to improve maternal health and outcomes in the United States: (1) Increasing access to and coverage of comprehensive high-quality maternal health services, including behavioral health services; (2) Ensuring women giving birth are heard and are decisionmakers in accountable systems of care; (3) Advancing data collection, standardization, harmonization, transparency, and research; (4) Expanding and diversifying the perinatal workforce; and (5) Strengthening economic and social supports for people before, during, and after pregnancy. Press Release Blueprint
  • On June 25, HHS released a notice called “Knowing Your Rights: Reproductive Health Care” in response to the Supreme Court decision to overturn Roe v. Wade. HHS noted its commitment to providing accurate and up-to-date information about access to and coverage of reproductive health care and resources. Notice

Infant Formula –

  • On June 21, HHS announced that 13 Operation Fly Formula flights are currently scheduled for the week of June 20, projected to import approximately four million eight-ounce bottle equivalents of infant formula to the United States. By June 26, Operation Fly Formula flights will have completed 32 flights and imported more than 17 million eight-ounce bottle equivalents of infant formula. Press Release
  • On June 22, the White House announced that through HHS, an Operation Fly Formula to transport Nestlé infant formula from Germany to Fort Worth, TX will occur on June 26. This delivery will include over 110,000 pounds of Nestlé SupremePro 2 formula, the equivalent of approximately 1.65 million eight-ounce bottle. Press Release
  • Also on June 22, the White House announced that through HHS, an Operation Fly Formula to transport Bubs Australia infant formula from Melbourne, Australia to Los Angeles, CA will occur on June 26 and to Philadelphia, PA on July 5. These deliveries will include in total approximately 320,000 pounds of Bubs Organic Infant Formula S1, Bubs Organic Follow On Formula S2, Bubs Supreme Infant Formula Supreme Follow On Formula, Bubs Goat Milk Infant Formula S1, and Bubs Goat Milk Follow On Formula S2, the equivalent of approximately 5.5 million eight-ounce bottles. Press Release
  • Also on June 22, the White House announced that through HHS, an Operation Fly Formula to transport Gerber infant formula from Mexico to Fort Worth, TX will occur starting on June 24. This delivery will include approximately one million pounds of Gerber Good Start Gentle infant formula, the equivalent of approximately 16 million eight-ounce bottles. Press Release
  • Also on June 22, the Food and Drug Administration (FDA) provided an update on the steps it has taken, and will continue to take, to ensure that American consumers have access to safe and nutritious infant formula in the coming weeks and months. Thus far, FDA flexibilities have resulted in approximately 365 million bottles worth of infant formula. Press Release
  • Also on June 22, the FDA provided an update on additional steps it has taken that will lead to more infant formula available in the U.S. under the agency’s recent increased flexibilities. More than 4.8 million cans (more than 8.5 million pounds or more than 128 million full-size, eight-ounce bottles) of Kendamil First Infant Formula with Iron (Kosher formula) have been imported into the US. Press Release
Misc. –
  • On June 21, President Biden announced his intent to nominate Dr. Arati Prabhakar to serve as Director of the Office of Science and Technology Policy (OSTP), and once confirmed to this position, Assistant to the President for Science and Technology. In this capacity, Dr. Prabhakar will be the President’s Chief Advisor for Science and Technology, a co-chair of the President’s Council of Advisors on Science and Technology, and a member of the President’s Cabinet. White House Press Release HHS Press Release
  • Also on June 21, the FDA announced plans to develop a proposed product standard that would establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain other combusted tobacco products. The goal of the potential rule would be to reduce youth use, addiction and death. Press Release
  • On June 22, HHS announced that the CDC began shipping monkeypox tests to five commercial laboratory companies, including the nation’s largest reference laboratories, to quickly increase monkeypox testing capacity and access in every community. The companies include Aegis Science, Labcorp, Mayo Clinic Laboratories, Quest Diagnostics and Sonic Healthcare. Press Release
  • On June 23, the FDA issued marketing denial orders (MDOs) to JUUL Labs Inc. for all of their products currently marketed in the United States. As a result, the company must stop selling and distributing these products. Press Release HHS Statement
  • Also on June 23, the FDA release its Action Plan for Rare Neurodegenerative Diseases including Amyotrophic Lateral Sclerosis (ALS) – a five-year strategy for improving and extending the lives of people living with rare neurodegenerative diseases by advancing the development of safe and effective medical products and facilitating patient access to novel treatments. Specific actions include regulatory science initiatives, enhancements to existing programs and new policy initiatives. Press Release Action Plan
Legislative Activity –
Votes and Committee Activity –
  • On June 22, the Advanced Research Projects Agency-Health (ARPA-H) Act (H.R. 5585) passed the House by a vote of 336-85. The bill establishes the Advanced Research Projects Agency-Health. The bill now heads to the Senate for consideration. Bill text Press release
  • Also on June 22, the Restoring Hope for Mental Health and Well-Being Act of 2022 (H.R. 7666) passed the House by a vote of 402-20. The bill reauthorizes certain programs relating to mental health and substance use disorders. The bill now heads to the Senate for consideration. Bill text Press release
  • On June 23, the LGBTQI+ Data Inclusion Act (H.R. 4176) passed the House by a vote of 220-201. The bill would improve Federal population surveys by requiring the collection of voluntary, self-disclosed information on sexual orientation and gender identity in certain surveys. The bill now heads to the Senate for consideration. Press release
  • Also on June 23, the Justice and Mental Health Collaboration Reauthorization Act of 2022 (S. 3846) passed the Senate without amendment by Unanimous Consent. The bill reauthorizes the Justice and Mental Health Collaboration Program. The bill now heads to the House for consideration. Bill text Press release
  • Also on June 23, the Fixing Our Regulatory Mayhem Upsetting Little Americans (FORMULA) Act (S.4261) passed the Senate by Unanimous Consent. The bill would suspend duties and other restrictions on the importation of infant formula to address the shortage of infant formula in the US. The bill now heads to the House for consideration. Bill text Press release
  • Also on June 23, the VA Electronic Health Record Transparency Act of 2021 (H.R. 4591) was signed into law by the President. The bill would increase transparency surrounding the Department of Veterans Affairs’ (VA) Electronic Health Record Modernization (EHRM) program. Press release
  • Also on June 23, the Enhancing Mental Health and Suicide Prevention Through Campus Planning Act (H.R. 5407) passed the House by a vote of 405-16. The bill would promote comprehensive campus mental health and suicide prevention plans. The bill now heads to the Senate for consideration. Press release
  • Also on June 23, the Supporting the Resilience of Our Nation’s Great (STRONG) Veterans Act of 2022 (H.R. 6411) passed the House by voice vote. The bill makes certain improvements in the mental health care provided by the Department of Veterans Affairs. The bill now heads to the Senate for consideration. Press release
  • Also on June 23, the House Appropriations Committee, Subcommittee on Labor, HHS, Education, and Related Agencies passed the Fiscal Year 2023 Labor, Health and Human Services, Education, and Related Agencies Funding Bill by voice vote. The bill now heads to the full House Appropriations Committee for consideration. Bill text Press release
  • Also on June 23, the House Energy & Commerce Committee, Subcommittee on Consumer Protection and Commerce held a markup of eight bills, including the bipartisan, bicameral American Data Privacy and Protection Act (H.R. 8152), the Informing Consumers about Smart Devices Act (H.R. 4081), and Reese’s Law (H.R. 5313). All eight bills were reported favorably to the full Committee. Bill texts Press release Markup notice Subcommittee Action Summary Sheet
  • On June 25, President Biden signed into law the Bipartisan Safer Communities Act (S. 2938), which enhances certain restrictions and penalties on firearms purchases, promotes evidence-based best practices for school safety, authorizes grants to expand access to mental health services, and appropriates emergency funding for mental health resources and school safety measures. The bill passed the Senate on June 23 and passed the House on June 24. Bill text Press release
  • Also on June 25, President Biden signed into law the Keep Kids Fed Act of 2022 (S. 2089), which extends certain flexibilities for child nutrition programs and provides temporary increases in reimbursement rates for school meals and meals provided at child care centers. The bill passed the Senate on March 7 and the House on June 23. Bill text Press release
Introduced Legislation –
  • On June 21, Rep. Ruiz (D-CA) introduced the Building a Sustainable Workforce for Healthy Communities Act (H.R. 8151), which would provide awards to support community health workers and community health. Bill text Press release
  • Also on June 21, Rep. O’Halleran (D-AZ) introduced the Improving Trauma Systems and Emergency Care Act (H.R. 8163), which would amend the Public Health Service Act with respect to trauma care.  Bill text Press release
  • On June 22, Reps. Pence (R-IN) and Craig (D-MN) introduced the Rural Telehealth Access Task Force Act (H.R. 8169), which would establish a Rural Telehealth Access Task Force to determine how to address barriers to the adoption of telehealth technology and access to broadband internet access service in rural areas.  Bill text Press release
  • Also on June 22, Rep. Banks (R-IN) and seven cosponsors introduced the Protecting Minors from Medical Malpractice Act (H.R. 8171), which would protect children from medical malpractice in the form of gender transition procedures. Sen. Cotton (R-IN) introduced the companion legislation in the Senate (S.4457). Bill text Press release
  • Also on June 22, Reps. Beyer (D-VA) and Schrier (D-WA) introduced the Improving Diagnosis in Medicine Act (H.R. 8172), which would improve the quality, appropriateness, and effectiveness of diagnosis in health care. Sens. Van Hollen (D-MD) and Lujan (D-NM) introduced the companion legislation in the Senate (S. 4468). Bill text Press release
  • Also on June 22, Reps. Buck (R-CO), Stanton (D-AZ), Joyce (R-OH), and Correa (D-CA) introduced the Stop Pills That Kill Act (H.R. 8175), which would prohibit certain acts related to fentanyl, analogues of fentanyl, and counterfeit substances. Sens. Grassley (R-IA), Feinstein (D-CA), Cornyn (R-TX), and Hassan (D-NH) introduced the companion legislation in the Senate on May 5, 2022. Bill text Press release
  • Also on June 22, Rep. Emmer (R-MN) introduced the Securing Facilities for Mental Health Services Act (H.R. 8179), which would provide parity with respect to access to the mortgage insurance for hospitals program for licensed hospitals. Press release
  • Also on June 22, Rep. Gonzales (R-TX) introduced the Undertaking Needed Investments in Therapy, Education and De-escalation (UNITED) Act (H.R. 8180), which would provide for increased authorization of funding to secure schools and improve access to mental health and crisis care. Press release
  • Also on June 22, Reps. Morelle (D-NY), Barragan (D-CA), and Fitzpatrick (R-PA) introduced the Screening for Communities to Receive Early and Equitable Needed Services (SCREENS) for Cancer Act (H.R. 8185), which would reauthorize and improve the National Breast and Cervical Cancer Early Detection Program for fiscal years 2023 through 2027. Sens. Baldwin (D-WI), Collins (R-ME), Cortez Masto (D-NV), Capito (R-WV), and Klobuchar (D-MN) introduced the companion legislation in the Senate (S. 4440). Press release
  • Also on June 22, Reps. Pascrell (D-NJ), Peters (D-CA), Hudson (R-NC), Schrader (D-OR), and Bilirakis (R-FL) introduced the Saving Access to Laboratory Services Act (SALSA) (H.R. 8188), which would improve the accuracy of market-based Medicare payment for clinical diagnostic laboratory services, to reduce administrative burdens in the collection of data. Press release
  • Also on June 22, Rep. Schiff (D-CA) and 18 cosponsors introduced the Equal Access to Reproductive Care Act (H.R. 8190), which would treat certain assisted reproduction expenses as medical expenses of the taxpayer. Bill text Press release
  • Also on June 22, Sens. Casey (D-PA), Young (R-IN), Scott (R-SC), and Kelly (D-AZ) introduced the Informing Grand Families Act (S.4443), which would provide information about available benefits and services to kinship caregivers. Press release
  • Also on June 22, Sens. Burr (R-NC) and Brown (D-OH) introduced the Saving Access to Laboratory Services Act (S. 4449), which would improve the accuracy of market-based Medicare payment for clinical diagnostic laboratory services, to reduce administrative burdens in the collection of data. Press release
  • On June 23, Reps. Houlahan (D-PA), Meijer (R-MI), and Hill (R-AR) introduced the CLIMB Act (H.R. 8208), which would promote early literacy among certain young children as part of pediatric primary care. Bill text Press release
  • Also on June 23, Rep. Maloney (D-NY) and 58 cosponsors introduced the Stop Anti-Abortion Disinformation Act (H.R. 8210), which would prescribe rules prohibiting disinformation in the advertising of abortion services. Sens. Menendez (D-NJ) and 15 cosponsors introduced the companion legislation in the Senate (S. 4469). Bill text Press release
  • Also on June 23, Rep. Nehls (R-TX) and 11 cosponsors introduced the Stop Child Abuse Act (H.R. 8212), which would rescind the Executive Order on Advancing Equality for Lesbian, Gay, Bisexual, Transgender, Queer, and Intersex Individuals. Press release
  • Also on June 23, Sens. Rosen (D-NV) and Cassidy (R-LA) introduced the Expanding Access to Mental Health Training Act (S. 4461), which would reauthorize the program for mental health awareness training grants. Press release
  • Also on June 23, Sen. Smith (D-MN) introduced the Protecting Access to Medication Abortion Act (S. 4467), which would preserve access to abortion medications. One pager Press release
  • Also on June 23, Sens. Casey (D-PA) and Cassidy (R-LA) introduced the Health Care Capacity for Pediatric Mental Health Act (S. 4472), which would expand the availability of mental, emotional, behavioral, and substance use disorder health services. One pager Press release
  • Also on June 23, Sens. Rubio (R-FL) and 13 cosponsors introduced the Prohibiting Federal Emergencies for Abortion Act (S. 4474), which would prohibit the declaration of a federal emergency relating to abortion. Bill text Press release
  • Also on June 23, Sens. Ernst (R-IA) and Grassley (R-IA) introduced the Insulin For Our Reoccurring Medical Needs (INFORM) Act (S. 4481), which would require the Secretary of Health and Human Services to collect and disseminate information about pharmaceutical affordability assistance programs. Press release