Health Care Policy Update – Weekly Wrap-Up and What’s Ahead – July 18, 2022


What’s Ahead: This Week

Hearings & Markups –

  • Tuesday, July 19
    • House Oversight and Reform Committee, Select Subcommittee on the Coronavirus Crisis, “Hearing on Understanding and Addressing Long COVID and its Health and Economic Consequences.” Additional information
    • House Energy & Commerce Committee, “Roe Reversal: The Impacts of Taking Away the Constitutional Right to an Abortion.” Additional information
  • Wednesday, July 20
    • Senate Committee on Veterans Affairs, “Hearing on Examining the Status of VA’s Electronic Health Record Modernization Program.” Additional information
    • Senate Committee on Appropriations, “Hearing on Food Safety and the Food and Drug Administration.” Additional information

Notable Policy Events –

  • Monday, July 18
  • Tuesday, July 19
    • HHS Office of the National Coordinator for Health Information Technology (ONC), “ONC SDOH Information Exchange Learning Forum – July 2022 Webinar.” Additional information
    • The Hill, “The Future of Health Care Summit.” Additional information
    • Centers for Medicare and Medicaid Services, “National Stakeholder Call with CMS Administrator, Chiquita Brooks-LaSure.” Press release
    • CDC, “Advisory Committee on Immunization Practices (ACIP) Public Meeting.” Additional information
  • Wednesday, July 20
    • Alliance for Health Policy, “Summit on Mental Health in America.” Additional information
    • S. News & World Report, “Webinar: How Community Partnerships Can Transform Children’s Healthcare.” Additional information
    • Urban Institute, “Improving the Collection of Race and Ethnicity Data for Health Plans to Advance Health Equity.” Additional information
    • Kaiser Family Foundation, “The Health Wonk Shop: Medication Abortion in a Post-Roe v. Wade America.” Additional information
    • STAT, “Democrats’ Last Chance for Drug Pricing Reform?” Additional information
  • Thursday, July 21
  • Friday, July 22
    • Washington Post Live, “Walensky on the latest COVID variants and public health safety.” Additional information

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

Medicare, Medicaid & Marketplaces –

  • On July 13, CMS released information regarding several types of health coverage options available to certain Ukrainian nationals. Fact Sheet
  • On July 14, Senate Finance Committee Chair Ron Wyden (D-OR) released a statement in response to a new Tax Policy Centeranalysis on who will pay to extend Medicare solvency. Statement
  • On July 15, CMS released the CY2023 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed rule, which makes policy and payment updates for hospital outpatient and ambulatory surgical centers. CMS also incorporated into the OPPS payment policies, enrollment procedures, and updates to the physician self-referral law for the new Rural Emergency Hospitals (REH) provider type. Press Release General Fact Sheet REH Fact Sheet Proposed Rule
  • Also on July 15, CMS released the 2022 Medicaid and CHIP Beneficiary Profile and Infographic, which provide an overview of the enrollment, expenditures, characteristics, health status and experience of the beneficiaries served by Medicaid and CHIP. Press Release Beneficiary Profile Infographic

Public Health & Prevention –

  • COVID-19 Data: To date, there are 89,067,445 total COVID-19 cases and 1,018,578 COVID-19 deaths in the United States. Also, 779,563,765 COVID-19 vaccines have been delivered and 599,289,113 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 July 11, the Government Accountability Office (GAO) recommended ways to improve CDC’s air passenger data system based on a report that examined CDC’s process for collecting and managing air passengers’ contact information to facilitate contact tracing. GAO provided three recommendations including that CDC redesign its data management system for air passenger information or deploy a new one. Report in Brief Report
  • Also on July 11, the CDC announced that Mayo Clinic Laboratories will begin testing for monkeypox using CDC’s orthopoxvirus test, which detects most non-smallpox related orthopoxviruses, including monkeypox. Press Release
  • Also on July 11, HHS announced that it secured 3.2 million doses of Novavax’s COVID-19 vaccine. The vaccine will be free to states, jurisdictions, federal pharmacy partners, and federally qualified health centers if it receives FDA Emergency Use Authorization and recommendation from the CDC. Press Release
  • On July 12, HHS published a study in the Journal of the American Medical Association (JAMA) finding that the rates of in-hospital adverse events for health care related patient harm fell significantly in the U.S. in the decade prior to the onset of the COVID-19 pandemic. Press Release
  • Also on July 12, the Biden Administration announced its strategy to manage BA.5 – a subvariant of the Omicron variant that currently accounts for a majority of COVID-19 cases in the U.S. The Administration will continue mobilizing the full strength and capabilities of the federal government and work with state and local leaders, health care workers, the private sector, and community- and faith-based organizations. Fact Sheet
  • Also on July 12, the CDC concluded an analysis of the state of antimicrobial resistance in the United States immediately following the 2020 peaks of the COVID-19 pandemic. The data show that the threat of antimicrobial resistant infection has gotten worse, with an alarming increase in resistant infections starting during hospitalization, growing an overall 15 percent from 2019 to 2020 among seven pathogens. Press Release Report
  • Also on July 12, leaders of the House Energy & Commerce Committee wrote to the FDA Commissioner Robert Califf to request an update on the agency’s plans for strengthening its food safety efforts. Press Release Letter
  • On July 13, President Biden announced his intent to appoint Dr. Mitchel Berger, Dr. Carol Brown, and Dr. Elizabeth Jaffee to the President’s Cancer Panel and outlined the Cancer Cabinet’s priority actions. The Cancer Panel will advise President Biden on barriers to and opportunities for progress in reducing the burden of cancer. Fact Sheet
  • Also on July 13, Quest Diagnostics announced that it will begin testing for monkeypox. The company has developed a real-time polymerase chain reaction (PCR) test that uses patient swab specimens to qualitatively detect non-variola orthpoxviruses and monkeypox virus DNA. The test is now available to health care providers nationwide (except in New York). Press Release
  • Also on July 13, the FDA issued an emergency use authorization for the Novavax COVID-19 Vaccine, Adjuvanted, for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. Press Release
  • Also on July 13, Senator Burr (R-NC) sent a letter to HHS Secretary Becerra demanding clarity on the Biden Administration’s strategy to respond to the monkeypox outbreak. Press Release Letter
  • On July 14, the CDC announced that Aegis Sciences will begin testing for monkeypox using CDC’s orthopoxvirus test, which detects most non-smallpox related orthopoxviruses, including monkeypox virus. Press Release
  • On July 15, HHS placed an order for another 2.5 million doses of Bavarian Nordic’s JYNNEOS vaccine to respond to the current monkeypox outbreak and strengthen the country’s smallpox preparedness. Deliveries from this order will begin arriving at the Strategic National Stockpile in 2023. Press Release
  • Also on July 15, HHS Secretary Becerra renewed the public health emergency for an additional 90 days. Renewal Declaration

Health IT, Privacy, & Digital Health –

  • On July 11, GAO reported a variety of issues found with the quality of agencies’ data submissions under the Digital Accountability and Transparency Act of 2014 (DATA Act). The report summarizes the results in the 57 reports OIG issued on or before December 31, 2021, assessing the quality of agencies’ federal spending data. Report in Brief Report
  • Also on July 11, the Federal Trade Commission (FTC) posted a blog related to location data, health data and other sensitive information and reiterated the FTC’s commitment to fully enforcing the law against illegal use and sharing of highly sensitive data. Blog
  • On July 12, ONC released a data brief showing the latest data on interoperable exchange of health information among office-based physicians in 2019. The brief also examines engagement in various aspects of interoperability and variation in interoperability by physician practice characteristics and the type of data exchanged. Data Brief
  • On July 14, the ONC announced that 100 percent of Certified Health IT Developers submitted attestations as a Condition of Certification in the ONC Certification Program, which was implemented as part of the ONC Cures Act Final Rule. Blog
  • On July 15, HHS announced the resolution of 11 investigations in its HIPAA Right of Access Initiative, which supports individuals’ right to timely access to their health records at a reasonable cost under the HIPAA Privacy Rule. This brings the total number of these enforcement actions to 38 since the initiative began. Press Release

Mental Health and Substance Use Disorder Policy –

  • On July 13, the FDA issued two warning letters to manufacturers for unlawfully marketing non-tobacco nicotine e-liquid products without the required authorization. Press Release
  • On July 15, HHS announced that the US will transition the National Suicide Prevention Lifeline to 988 for easier access to 24/7 crisis care. The lifeline also links to the Veterans Crisis Line. Press Release Secretary Becerra Statement

Prescription Drugs, Medical Devices, and Biomedical Research –

  • On July 12, the FDA issued warning letters to four companies for illegally selling honey-based products that may pose a significant health risk to consumers. The undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Press Release
  • On July 15, the Congressional Budget Office (CBO) released its estimated budgetary effects of the Improving Needed Safeguards for Users of Lifesaving Insulin Now Act. CBO estimates that the average annual cost to comply with the mandates would exceed the private-sector threshold established in the Unfunded Mandates Reform Act ($184 million in 2022, adjusted annually for inflation). CBO Score

Veterans Health and Military Health  –

  • On July 13, the Department of Veterans Affairs (VA) reported a focused evaluation, by the OIG Comprehensive Healthcare Inspection Program, of the quality of care delivered in the inpatient and outpatient settings of the Martinsburg VA Medical Center. The inspection covered key clinical and administrative processes associated with promoting quality care and issued nine recommendations for improvement. Report in Brief Report
  • Also on July 13, House Committee on Veterans’ Affairs (HVAC) Chairman Mark Takano (D-CA) issued a statement on the passage of S.3373, the vehicle used to carry the Honoring our PACT Act. The Honoring our PACT Act addresses the full scope of issues affecting toxic-exposed veterans’ access to VA care and benefits, while reforming VA’s presumptive decision-making process. Statement
  • On July 14, the VA reported a focused evaluation, by the OIG Comprehensive Healthcare Inspection Program, of the leadership performance and oversight by Veterans Integrated Service Network (VISN) 5: VA Capitol Health Care Network in Linthicum, Maryland, covering leadership and organizational risks and key processes associated with promoting quality care. OIG issued one recommendation for improvement. Report in Brief Report
  • Also on July 14, VA OIG released an administrative investigation addressing concerns of possible misconduct by two leaders responsible for overseeing medical facility staff training on implementing VA’s new patient electronic health record system. The investigation revealed that while the leaders were not intentionally misleading, their lack of diligence resulted in delays and misinformation being submitted. Report in Brief Report
  • Also on July 14, VA OIG released a report on an inspection that was conducted to assess a safety concern with the new VA electronic health record that resulted in patient harm. The OIG found that the new EHR sent thousands of orders for medical care to an undetectable location, or unknown queue, instead of to the intended location. Report in Brief Report
  • On July 15, leaders from the House Committee on Oversight and Reform, and the Subcommittee on National Security, sent letters to three veteran records-retrieval companies requesting information about their potential misuse of National Personnel Records Center (NPRC) procedures, including their records request procedures, their use of emergency requests, and their terms of use. Press Release

Health Systems, Public Health & Health Equity –

  • On July 13, OIG published a study that interviewed CDC staff responsible for collecting and analyzing COVID-19 data. The study concluded that the CDC found ways to use data to understand and address COVID-19 health disparities, despite challenges with existing data. Report in Brief Report
  • Also on July 13, HHS released apractice guide as a resource for a broad range of human services programs aiming to be more inclusive of and responsive to fathers. Report in Brief Report

Maternal Health

  • On July 11, HHS issued clarifying guidance on the Emergency Medical Treatment and Active Labor Act (EMTALA) to ensure all patients have access to the full rights and protections for emergency medical care afforded under the law. The guidance reaffirmed that EMTALA protects providers when offering legally mandated, life- or health-saving abortion services in emergency situations. In addition to the guidance, Secretary Becerra published a letter to providers stating that this federal law preempts state law restricting access to abortion in emergency situations. Press Release Letter
  • Also on July 11, Reps. Lieu (D-CA) and Ocasio-Cortez (D-NY) sent a letter to Senate Majority Leader Schumer (D-NY) urging Senate leadership to state on the record whether they believe Justices Kavanaugh and Gorsuch lied under oath to the Senate Judiciary Committee in regard to established precedent of Roe v. Wade and Casey v. Planned Parenthood during their confirmation hearings. Press Release Letter
  • On July 12, the Department of Justice (DOJ) announced the establishment of the Reproductive Rights Task Force, which formalizes an existing working group and efforts by the DOJ to identify ways to protect access to reproductive health care. The Task Force will monitor and evaluate state and local legislation and enforcement actions that threaten various reproductive rights as a result of the Dobbs Press Release
  • On July 13, HHS issued clarifying guidance to retail pharmacies on their obligations to ensure access to comprehensive reproductive health care services including prescribed medications; making determinations regarding the suitability of prescribed medications for a patient; and advising a patient about prescribed medications and how to take them.  Press Release
  • Also on July 13, Senators Feinstein (D-CA), Murray (D-WA), and Warren (D-MA) led 15 Senate Democrats in calling on Senate and House Democratic leadership to support robust funding for the Title X Family Planning Program after the Supreme Court overturned Roe v. Wade. Press Release Letter
  • Also on July 13, Reps. Doggett (D-TX) and Fletcher (D-TX) led a group of 83 lawmakers in urging the Biden Administration to issue a national emergency declaration and a Public Health Emergency declaration on abortion access, and to use authorities under the PREP Act to help ensure continued access to medication abortion across the country. Press Release Letter
  • On July 14, the House Committee on Oversight and Reform issued a press release highlighting key takeaways from a hearing held on July 13 to examine the impact of the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization. Press Release
  • Also on July 14, the Texas Attorney General filed a lawsuit against the Biden Administration challenging the guidance released earlier this week on EMTALA, claiming that this new guidance forces hospitals and doctors to commit crimes and risk their licensure under Texas law. Lawsuit

Infant Formula –

  • On July 11, HHS announced there were six Operation Fly Formula flights scheduled for the week of July 11, projected to import eight million eight-ounce bottle equivalents of infant formula to the US. Press Release
  • On July 14, the FDA announced the availability of educational resources for parents and caregivers with questions about using imported infant formula that is headed to the U.S. The FDA is creating “Names to Know” graphics featuring the label pictures and details about imported formulas to help parents and caregivers recognize these products. Press Release

Misc. –

  • On July 11, the White House released a fact sheet on 21 ways the Biden Administration is actively using executive action to make communities safer by addressing gun violence. Fact Sheet
  • On July 12, Senate Finance Committee Chair Wyden (D-OR) announced the nomination of Dr. Rebecca Haffajee to serve as the Assistant Secretary for Planning and Evaluation at the Department of Health and Human Services. Also announced was the nomination of Dr. Jay Shambaugh to serve as Under Secretary for International Affairs at the Treasury Department. Press Release Remarks

Legislative Activity –

Votes and Committee Activity –

  • On July 13, the Prevent Exposure to Narcotics and Toxics (PREVENT) Act of 2021 (H.R. 5274) passed the House by a vote of 429-0. The bill provides training for U.S. Customs and Border Protection personnel on the use of containment devices to prevent secondary exposure to fentanyl and other potentially lethal substances. The bill now heads to the Senate for consideration. Bill text Press release
  • Also on July 13, the House Energy & Commerce Committee marked up five bills. Press release Ranking Member Press release
    • The Spectrum Innovation Act of 2022 (H.R. 7624) was passed, as amended, by a vote of 52-0.
    • The Ensuring Phone and Internet Access Through Lifeline and Affordable Connectivity Program Act of 2022 (H.R. 4275) was passed, as amended, by a vote of 48-0.
    • The Institute for Telecommunication Sciences (ITS) Codification Act (H.R. 4990) was passed, as amended, by a vote of 51-0.
    • The Safe Connections Act of 2022 (H.R. 7132) was passed, as amended, by a vote of 53-0.
    • The Lymphedema Treatment Act (H.R. 3630) was passed, as amended, by voice vote.
  • On July 14, Senator Cortez Masto (D-NV) and Senate HELP Committee Chair Murray (D-WA), sought unanimous consent to pass the Freedom to Travel for Health Care Act of 2022 (S.4504) to protect Americans’ ability to travel across state lines and reproductive rights. Senator Lankford (R-OK) blocked the effort. Press release
  • Also on July 14, the National Defense Authorization Act for Fiscal Year 2023 (H.R. 7900) passed the House by a vote of 329-101. The bill, which authorizes FY2023 appropriations for military activities and programs of the Department of Defense, contains a number of health care provisions related to TRICARE and other Department of Defense related programs. The bill now goes to the Senate for consideration. Bill text Press release
  • On July 15, the Ensuring Access to Abortion Act of 2022 (H.R. 8297) passed the house by a vote of 223-205. The bill would prohibit anyone acting under state law from interfering with a person’s ability to access out-of-state abortion services. The bill now goes to the Senate for consideration. Bill text Press release
  • Also on July 15, the Women’s Health Protection Act of 2022 (H.R. 8296) passed the House by a vote of 219-210. The bill would prohibit governmental restrictions on the provision of, and access to, abortion services. The bill now goes to the Senate for consideration. Bill text

Introduced Legislation –

  • On July 11, Reps. Huffman (D-CA), Kuster (D-NH), Raskin (D-MD), and Pocan (D-WI) introduced the Health Share Transparency Act of 2022 (H.R. 8324), which would establish requirements for the disclosure of certain information relating to health care sharing ministries. Bill text Press release
  • Also on July 11, Sens. Blackburn (R-TN), Risch (R-ID), and Crapo (R-ID) introduced legislation (S. 4499), which would prohibit any requirement that a member of the National Guard receive a vaccination against COVID-19. Bill text
  • On July 12, Reps. Golden (D-ME) and McKinley (R-WV) introduced legislation (H.R. 8332), which would repeal the VA Asset and Infrastructure Review Act of 2018. Press release
  • Also on July 12, Sens. Duckworth (D-IL) and six cosponsors introduced the Public Health Air Quality Act of 2022 (S. 4510), which would protect clean air and public health by expanding fence line and ambient air monitoring and access to air quality information for communities affected by air pollution. Press release
  • Also on July 13, Rep. Axne (D-IA) and six cosponsors introduced the Locked Out Workers’ Healthcare Protection Act (H.R. 8345), which would prohibit an employer from terminating the coverage of an employee under a group health plan while the employer is engaged in a lock-out. Press release
  • Also on July 13, Reps. DeLauro (D-CT), Barragan (D-CA), Panetta (D-CA), Moore (D-WI), Jackson Lee (D-TX), and Watson Coleman (D-NJ) introduced the Food Safety Administration Act (H.R. 8358), which would protect the public health by ensuring the safety of food, preventing foodborne illness, maintaining safety reviews and reassessments of food additives, enforcing pesticide residue tolerances, and improving the surveillance of foodborne pathogens. Sens. Durbin (D-IL) and Blumenthal (D-CT) introduced the companion legislation in the Senate (S. 4520). Bill text Fact sheet Press release
  • Also on July 13, Reps. Jayapal (D-WA) and Curtis (R-UT) introduced the Preventing Suicide Through Voluntary Firearm Purchase Delay Act (H.R. 8361), which would help prevent suicide by giving people more control over their own lethal means purchase decisions, through the creation of a voluntary purchase delay database. Press release
  • Also on July 13, Sens. Braun (R-IN), Rubio (R-FL), and Hassan (D-NH) introduced legislation (S. 3372), which would strengthen benefits for children of Vietnam veterans born with spina bifida. Bill text
  • Also on July 13, Sen. Bennet (D-CO) introduced the Supporting Mental Assistance Responder Teams (SMART) Community Policing Act (S. 4513), which would provide funding or innovations in community policing, mental health care, and community safety. Bill text One pager Press release
  • Also on July 13, Sen. Cramer (R-ND) and nine cosponsors introduced the Unborn Child Support Act (S. 4512), which would ensure that child support for unborn children is collected and distributed under the child support enforcement program. Bill text Press release
  • Also on July 13, Sen. Rubio (R-FL) and eight cosponsors introduced the Prohibiting Abortion on Federal Lands Act (S. 4519), which would prohibit the Federal Government from promoting, supporting, or contracting with abortion entities, or otherwise expanding access to abortions on Federal lands or in Federal facilities. Bill text Press release
  • On July 14, Rep. Boebert (R-CO) and 29 cosponsors introduced the Shall Not Be Infringed Act (H.R. 8374), which would repeal the Bipartisan Safer Communities Act. Bill text Press release
  • Also on July 14, Rep. Mace (R-SC) introduced the Standing with Moms Act (H.R. 8384), which would furnish tailored information to expecting mothers. Sen. Rubio (R-FL) and eight cosponsors introduced the companion legislation in the Senate (S. 4541). Bill text Press release
  • Also on July 14, Reps. Trone (D-MD), Raskin (D-MD), and Fitzpatrick (R-PA) introduced the Continuity in Necessary Evaluative Crisis Treatment (CONNECT) Act (H.R. 8391), which would direct the Secretary of HHS, acting through the Assistant Secretary for Mental Health and Substance Abuse, to award grants to eligible crisis centers to provide follow-up services to individuals receiving suicide prevention and crisis intervention services. Bill text One pager Press release
  • Also on July 14, Sen. Burr (R-NC) introduced the Food and Drug Administration Simple Reauthorization Act (S. 4535), which would revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products. Bill text Press release